{"nct_id":"NCT04999163","start_date":"2021-12-31","phase":"N/A","enrollment":50,"brief_title":"Aortix Therapy for Perioperative Reduction of Renal Injury","official_title":"Aortix Therapy for Perioperative Reduction of Renal Injury","primary_completion_date":"2022-12-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2023-06-30","last_update":"2021-08-10","description":"The study is a prospective, non-randomized feasibility study to evaluate the safety and performance of providing support with the Aortix System to patients at heightened risk of acute kidney injury (AKI) undergoing abdominal or cardiovascular surgery.","other_id":"PVP054","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":21,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Have the following risk factor(s) for AKI prior to surgery:\r\n\r\n               1. Estimated glomerular filtration rate (eGFR) of  15 and < 30 ml/min/1.73m2, OR\r\n\r\n               2. eGFR  30 and < 60 ml/min/1.73m2 and ONE or more of the following:\r\n\r\n                    1. Diabetes (regardless of cause) with metabolic, renal, ophthalmic,\r\n                       neurologic, circulatory, or other complications\r\n\r\n                    2. Documented NYHA class III or IV heart failure within 1 year prior to\r\n                       enrollment\r\n\r\n                    3. Left ventricular ejection fraction < 35%\r\n\r\n                    4. Hypertension with comorbid heart or kidney disease\r\n\r\n                    5. Persistent Atrial Fibrillation\r\n\r\n          2. Planned abdominal or cardiac surgical procedure (that does not use femoral artery\r\n             cannulation for cardiopulmonary bypass) including, but not limited to:\r\n\r\n               1. Cardiac surgery including bypass surgery, surgical valve replacement or valve\r\n                  repair OR\r\n\r\n               2. Abdominal surgery including gastrointestinal, liver, or pancreatic surgery\r\n\r\n          3. Age >21 years, willing and able to provide written informed consent.\r\n\r\n             -\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. An eGFR of <15 ml/min/1.73m2 at enrollment\r\n\r\n          2. Current support with a durable LVAD, intra-aortic balloon pump, extracorporeal\r\n             membrane oxygenation (ECMO), or percutaneous ventricular assist devices (e.g., Impella\r\n             or TandemHeart)\r\n\r\n          3. Patient has known hypo- or hyper-coagulable state such as disseminated intravascular\r\n             coagulation or heparin induced thrombocytopenia (HIT)\r\n\r\n          4. Endovascular procedure with ilio-femoral access >12F within previous 30 days\r\n\r\n          5. Severe Bleeding Risk (any of the following):\r\n\r\n               1. Previous intracranial bleed such that the patient cannot safely use\r\n                  anticoagulation per the study requirements\r\n\r\n               2. Platelet count <75,000 cells/mm3\r\n\r\n               3. Uncorrectable bleeding diathesis or coagulopathy (e.g., INR  2 not due to\r\n                  anticoagulation therapy\r\n\r\n          6. Current endovascular stent graft in the descending aorta or ilio-femoral vessels\r\n\r\n          7. Contraindicated Anatomy:\r\n\r\n               1. Descending aortic anatomy that would prevent safe placement of the device [<18 mm\r\n                  or >31 mm aorta diameter at deployment location (measured between the superior\r\n                  aspect of the T10 vertebra and superior aspect of the L1 vertebra)]\r\n\r\n               2. Ilio-femoral diameter or peripheral vascular anatomy that would preclude safe\r\n                  placement of a 21F (outer diameter) introducer sheath\r\n\r\n               3. Abnormalities or severe vascular disease that would preclude safe access and\r\n                  device delivery (e.g., aneurysm with thrombus; marked tortuosity; significant\r\n                  narrowing or inadequate size of the abdominal aorta, iliac, or femoral arteries;\r\n                  or severe calcification)\r\n\r\n               4. Known connective tissue disorder (e.g., Marfan Syndrome) or other aortopathy at\r\n                  risk of vascular injury\r\n\r\n          8. Known hypersensitivity or contraindication to study required medications (e.g.,\r\n             anticoagulation therapy) or device materials (e.g., history of severe reaction to\r\n             nickel or nitinol)\r\n\r\n          9. Positive pregnancy test if of childbearing potential\r\n\r\n         10. Participation in any other clinical investigation that is likely to confound study\r\n             results or affect the study\r\n\r\n             -\r\n      ","sponsor":"Procyrion","sponsor_type":"Industry","conditions":"Acute Kidney Injury","interventions":[{"intervention_type":"Device","name":"Device: Aortix System","description":"Aortix is indicated as a partial circulatory support device to increase renal perfusion and reduce the incidence of acute kidney injury (AKI) in patients undergoing abdominal or cardiac surgeries who are at heightened risk of developing AKI."}],"outcomes":[{"outcome_type":"primary","measure":"Safety","time_frame":"Enrollment to 30 days post-surgery","description":"Report the rate of Occurrence of Serious Adverse Events related to the Aortix therapy"},{"outcome_type":"primary","measure":"Effectiveness","time_frame":"baseline to 72 hours post-surgery","description":"Characterize change in AKI observed pre and post-surgery using the KDIGO criteria"},{"outcome_type":"primary","measure":"Effectiveness","time_frame":"Aortix placement to 30 days post- surgery","description":"Characterize the rate of perioperative use of renal replacement therapy (RRT), ultrafiltration and/or dialysis"},{"outcome_type":"primary","measure":"Effectiveness","time_frame":"If discharged by day 30 post-surgery","description":"Characterize the rate of 30-day post-surgery readmission due to worsening renal function"},{"outcome_type":"primary","measure":"Effectiveness","time_frame":"Admission to 30 days post-surgery","description":"Characterize the rate of patients remaining hospitalized 7, 14 and 30 days post-surgery"},{"outcome_type":"primary","measure":"Effectiveness","time_frame":"Admission to 30 days post-surgery","description":"Characterize the length of stay in the ICU/CCU post-surgery"}]}
{"nct_id":"NCT05033782","start_date":"2021-12-01","enrollment":1500,"brief_title":"Impact of the Modifications of Environmental Exposures and Health Care Access During COVID-19 Lockdown on Multiple Sclerosis","official_title":"Impact of the Modifications of Environmental Exposures and Health Care Access During COVID-19 Lockdown on the Risk of Multiple Sclerosis Clinical Relapse or Clinical Worsening","primary_completion_date":"2022-09-01","study_type":"Observational","rec_status":"Not yet recruiting","completion_date":"2022-09-15","last_update":"2021-09-05","description":"Multiple Sclerosis (MS) is a demyelinating auto immune disease of the central nervous system, affecting 2500000 people worldwide. Risk factors for MS severity are not yet well-known , but previous studies highlighted that relapse rate increased during influenzae epidemics, and air pollution could be a risk factor for MS relapses. MS is a neurological chronic disease that requires constant medical treatment and regular rehabilitation care. COVID-19 pandemic and restrictive measures taken to limit contaminations have drastically decreased air pollution and seasonal viral infections exposure, but sanitary crisis also limited care access for MS patients (medical treatment, rehabilitation). Therefore, this particular period offers a unique opportunity to evaluate the impact of air pollution, viral infections, and health care access on the severity of MS. The main objective is to evaluate the impact of air pollution and seasonal viral infections on the risk of MS relapse, using the year 2020 as a quasi-experimental model. The secondary objective will be to evaluate the impact of health care access limitations on the risk of neurological disability accumulation. This study will include 1500 MS patients, living in Ile de France, followed in the neurological department of Piti-Salptrire Hospital. This is a retrospective observational study nested in OFSEP registry (Observatoire Francais de la Sclrose en Plaques), which is a prospective cohort of MS patients in France. Air pollution data will come from AIRPARIF, and viral infections data will come from Sant Publique France. A better knowledge of the impact of air pollution, viral infections, and health care access on the course of MS will enable to better guide information to patients and public health care decisions.","other_id":"APHP210935","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients living in Ile de France and followed in the neurology department of the Piti\r\n        Salptrire Hospital in Paris for relapsing-remitting MS.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  MS defined by the Mac-Donald 2017 criteria\r\n\r\n          -  Age greater than or equal to 18 years\r\n\r\n          -  Relapsing-remitting form\r\n\r\n          -  Patient residing in Ile de France\r\n\r\n          -  Patient included in the OFSEP registry Observatoire Franais de la Sclrose en\r\n             Plaques) with at least one visit before 2020 and at least one after January 2021\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Secondary progressive or primary progressive MS\r\n      ","sponsor":"Assistance Publique - Hpitaux de Paris","sponsor_type":"Other","conditions":"Multiple Sclerosis","interventions":[{"intervention_type":"Other","name":"Other: questionnaire","description":"Each included patient will be given a paper questionnaire, with the following questions:\r\nZip code of patient's iterative residences since 2018, as well as the zip code of residence at the time of the 2 confinements\r\nOccupational status\r\nOccurrence of COVID infection/date needed for hospitalization\r\nDuring the COVID-19 outbreak, did the patient: avoid seeing a doctor, avoid going to health care facilities, stop background treatment for MS. If yes to any of the questions, the reason, date and duration of the cessation will be asked.\r\nOther sources of data will be used together:\r\nClinical data from the OFSEP registry Pollution data from approved air quality monitoring associations Data on the circulation of influenza and gastroenteritis, produced by Sant Publique France"}],"outcomes":[{"outcome_type":"primary","measure":"Multiple Sclerosis Relapse","time_frame":"01/01/2018 - 01/01/2022","description":"a neurologic deficit associated with an acute inflammatory demyelinating event that lasts at least 24 hours in the absence of fever and infection"},{"outcome_type":"secondary","measure":"Neurological disability accumulation","time_frame":"01/01/2018 - 01/01/2022","description":"increase of EDSS of 1.5 points for EDSS <2, and 1 point for EDSS [2-5.5], and 0.5 point for EDSS >5.5."}]}
{"nct_id":"NCT05002153","start_date":"2021-11-30","phase":"N/A","enrollment":300,"brief_title":"The Role of Microbiome in Recurrent Obesity","official_title":"The Role of Microbiome in Recurrent Obesity","primary_completion_date":"2023-02-28","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2024-11-30","last_update":"2021-08-19","description":"This past century witnessed a significant increase in the prevalence of obesity, when since 1980 worldwide obesity has more than doubled. According to the World Health Organization, 39% of adults from the age of 18 years or older are overweight while 13% are obese. Successful maintenance of weight loss as losing at least 10% of the initial body weight and maintaining it for at least one year. However, keeping the low body weight is rarely maintained, as 80% of people who lost 10% of their body weight will return to their initial weight within a year. When weight loss is maintained for 2-5 years the chance of long term success was shown to dramatically increase. Although there is no agreement as to what contributes to the recurrent weight regain phenomenon (also known as 'weight cycling' or 'yo-yo diet'), it is strongly associated with the risk of developing metabolic risk factors and their complications including heart disease and all-cause mortality. Altering the gut microbiota is one method to treat disease states associated with gut bacteria. For instance, fecal microbiota transplant (FMT) or fecal bacteriotherapy, is the process of transferring stool from a healthy donor to another. The goal of FMT is to restore host health by increasing diversity and function of the gut microbiota. The main advantage of FMT over probiotics is its ability to transplant the entire gut microbiota and metabolites from the donor to the recipient. Although numerous individual microbes have been identified as related to obesity, multiple studies suggest that loss of microbial diversity has a stronger impact on the development of metabolic dysfunction, this diversity may be restored by FMT. This study will determine whether microbiome modulation might be a possible future target against recurrent obesity in humans, and whether orally administered FMT from a lean donor, post weight loss might be an effective intervention to prevent weight regain.","other_id":"0215-19-ASF","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  28<BMI>35\r\n\r\n          -  Age: 18-65\r\n\r\n          -  Capable of working with a smartphone application\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Consumption of antibiotics/probiotics/oral antifungals 3 months prior to the first day\r\n             of the experiment.\r\n\r\n          -  Pregnancy, fertility treatments, breastfeeding women six months prior to enrollment\r\n             and during the study.\r\n\r\n          -  Chronic disease (e.g. AIDS, Cushing syndrome, CKD, acromegaly,\r\n             hyperthyroidism/hypothyroidism etc.)\r\n\r\n          -  Cancer and recent anticancer treatment\r\n\r\n          -  Psychiatric disorders\r\n\r\n          -  Coagulation disorders\r\n\r\n          -  IBD (inflammatory bowel diseases)\r\n\r\n          -  Bariatric surgery\r\n\r\n          -  Eating disorders (Anorexia nervosa. Bulimia nervosa. Binge eating disorder, Night\r\n             eating syndrome).\r\n\r\n          -  Alcohol or substance abuse\r\n\r\n          -  Weight loss attempts one year prior to the first day of the experiment - independent\r\n             or with a dietitian.\r\n      ","sponsor":"Assaf Harofeh MC","sponsor_type":"Other","conditions":"Obesity|Weight Loss|FMT","interventions":[{"intervention_type":"Other","name":"Other: Fecal microbiota transplantation (FMT)","description":"FMT is the process of transferring stool from a healthy donor to another."},{"intervention_type":"Other","name":"Other: Placebo","description":"Placebo capsules consist a combination of agarose in normal saline/glycerol (the same vehicle as in a FMT capsules)"}],"outcomes":[{"outcome_type":"secondary","measure":"Glycemic Response","time_frame":"1.5 years","description":"Performing continuous glucose monitoring (CGM) and oral glucose tolerance test (OGTT)"},{"outcome_type":"secondary","measure":"Metabolic Rate","time_frame":"1.5 years","description":"RMR"},{"outcome_type":"secondary","measure":"Substrate Utilization","time_frame":"1.5 years","description":"measured by indirect calorimetry"},{"outcome_type":"primary","measure":"Microbiome Profiling","time_frame":"1.5 years","description":"Collection of stool, urine and oral samples for microbiome composition. 16S RNA analysis."},{"outcome_type":"primary","measure":"Reaching Target Weight","time_frame":"1.5 years","description":"Investigate the effect of FMT administration after reaching target weight (kg) on the recurrent weight regain phenomenon."}]}
{"nct_id":"NCT04472702","start_date":"2021-11-30","phase":"N/A","enrollment":45,"brief_title":"Fluoroscopic Versus Ultrasound Guidance for Cooled Radiofrequency Ablation of Geniculate Nerves in Knee Osteoarthritis: A Randomized Control Trial","official_title":"Fluoroscopic Versus Ultrasound Guidance for Cooled Radiofrequency Ablation of Geniculate Nerves in Knee Osteoarthritis: A Randomized Control Trial","primary_completion_date":"2022-10-01","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2023-06-01","last_update":"2021-09-09","description":"Cooled radiofrequency ablation (cRFA) of the knee geniculate nerves is a promising treatment option for knee osteoarthritis, but has variable efficacy. Fluoroscopy is the typical guidance of choice, but uses bony landmarks to target these nerves which have variable positions around the knee. Alternatively, ultrasound allows for targeting based on visualization of bony landmarks, the nerves, and their accompanying vascular structures, and thus may offer greater accuracy. However, there are few studies which directly compare the clinical efficacy of these two guidance options. This study will compare these two options.","other_id":"IRB202001574","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","intervention_model_description":"Participants (N=90; 45 at each site) will be randomized with equal probability to either treatment group, restricted by equal enrollment and equal distribution at each site. Patients will be enrolled for the exploratory aim separately at the University of Florida site only. After enrollment into the main study (primary and secondary aims), subjects at the UF site will be offered enrollment into the exploratory aim (N=24) on a consecutive basis restricted by equal enrollment into each treatment arm. A random number table will be used for group allocation and the values recorded separately into opaque, sealed envelopes. This will be performed by a clinical coordinator who is not involved in study to ensure allocation concealment. Outcomes for the primary, secondary, and exploratory aims will be completed by research staff who are blinded to the subject treatment allocation. Data analyses will also be completed in a blinded fashion by the study statistical consultant.","sampling_method":"","gender":"All","minimum_age":35,"maximum_age":99,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  1) patients of either gender with primary knee OA of one or both knees fulfilling the\r\n             diagnostic criteria for knee OA by the American College of Rheumatology,\r\n\r\n          -  2) Kellgren-Lawrence score of two to four,\r\n\r\n          -  3) reported NPRS pain intensity of at least four on most or all days of the past week\r\n\r\n          -  4) pain resistant to conventional treatments which may include but is not limited to\r\n             medications (e.g. acetaminophen, oral or topical non-steroidal anti-inflammatory\r\n             drugs, opioids), physical therapy, and intra-articular injections (e.g.\r\n             corticosteroids, hyaluronic acid, platelet-rich-plasma) for at least 3 months. In the\r\n             case of bilateral knee OA, the most symptomatic knee will be treated and studied.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  1) age <35 years,\r\n\r\n          -  2) non-English speaking patients,\r\n\r\n          -  3) body mass index greater than 40,\r\n\r\n          -  4) previous radiofrequency ablation procedure for the knee,\r\n\r\n          -  5) active systemic or local infections at the site of needle/cRFA probe placement,\r\n\r\n          -  6) previous knee joint replacement surgery,\r\n\r\n          -  7) autoimmune or inflammatory cause of knee arthritis such as rheumatoid or psoriatic\r\n             arthritis,\r\n\r\n          -  8) non-ambulatory patients,\r\n\r\n          -  9) patients who are unable to provide their own consent (e.g. dementia),\r\n\r\n          -  10) unstable medical or psychiatric illness,\r\n\r\n          -  11) patients with pacemakers, spinal cord stimulators, deep brain stimulators, or\r\n             similar devices,\r\n\r\n          -  12) patients seeking care as a part of workman's compensation or have litigation\r\n             pending\r\n\r\n          -  13) a negative response to diagnostic geniculate nerve lidocaine injections.\r\n      ","sponsor":"University of Florida","sponsor_type":"Other","conditions":"Knee Osteoarthritis","interventions":[{"intervention_type":"Procedure","name":"Procedure: cRFA","description":"cRFA intervention will occur under sterile conditions, the patient will be placed in a supine position on a table and a bolster to provide flexion in the treated knee joint. Skin and soft tissues will be anaesthetized with 2 mL 1% lidocaine at each of the three anatomic sites for cRFA, and a introducer needle will then be placed under ultrasound or fluoroscopic guidance to the SLG, SMG, and IMG nerves. Adjustments at these positions will be made when using ultrasound guidance in order to capture the geniculate nerve if the nerve and/or its accompanying vasculature can be directly visualized using greyscale or Doppler modes. When using ultrasound, the physician will note and record whether their positioning of the needle is based on bony landmarks, direct visualization of the nerve, and/or vascularity accompanying the nerve. Once the introducer needle is placed, the cRFA will be placed into the introducer needle."}],"outcomes":[{"outcome_type":"primary","measure":"Numeric Pain Rating Scale","time_frame":"Baseline up to 24 months","description":"The objective is to rate patient's reported pain. The NPRS asks for a number between zero and ten that fits best to the subject's pain intensity, with zero as \"no pain at all\" and ten representing \"the worst pain ever possible\". It has a similar minimal clinically significant difference (20%) as the visual analog scale and can be administered via a phone interview."},{"outcome_type":"primary","measure":"Western Ontario and McMaster Universities Arthritis Index (WOMAC)","time_frame":"Baseline up to 24 months","description":"The objective is to measure the patient's reported functional status.The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).\r\nThe scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score, however there are other methods that have been used to combine scores"},{"outcome_type":"primary","measure":"PROMIS - Depression","time_frame":"Baseline up to 24 months","description":"The objective is to measure items relevant to the subject's mood, views of self, and engagement. The test version 8b has good responsiveness with a minimally important difference range of 3-3.1 in adults with knee OA."},{"outcome_type":"primary","measure":"PROMIS - Pain Interference","time_frame":"Baseline up to 24 months","description":"The objective is to measure the consequences of pain on the subject's life with a minimally important difference range of 2.35 to 2.4"},{"outcome_type":"secondary","measure":"30-Second Chair Stand Test","time_frame":"The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods.","description":"The objective is to determine the maximum number of chair stand repetitions possible in a 30 second period."},{"outcome_type":"secondary","measure":"Stair Climb Test","time_frame":"The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods.","description":"The objective is to determine the time (seconds) it takes to ascend and descend a flight of stairs."},{"outcome_type":"secondary","measure":"40m Fast Paced Walk Test","time_frame":"The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods.","description":"The objective is to determine the time (seconds) it takes to complete a fast-paced walking task over 4x10m (total 40m)."},{"outcome_type":"secondary","measure":"Timed Up and Go Test48","time_frame":"The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods.","description":"The objective is to determine the time (seconds) to rise from a chair, walk 3m, turn, walk back to the chair, and then sit down."},{"outcome_type":"secondary","measure":"Six Minute Walk Test","time_frame":"The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods.","description":"The objective is to determine the maximal distance covered in a 6min period."}]}
{"nct_id":"NCT05032157","start_date":"2021-11-30","phase":"Phase 3","enrollment":450,"brief_title":"A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1- Antihistamines","official_title":"A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of Remibrutinib (LOU064) to Investigate the Efficacy, Safety and Tolerability for 52 Weeks in Adult Chronic Spontaneous Urticaria (CSU) Patients Inadequately Controlled by H1-antihistamines","primary_completion_date":"2024-02-02","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2024-03-01","last_update":"2021-09-02","description":"The purpose of this study is to establish the efficacy, safety, and tolerability of remibrutinib (LOU064) in adult participants suffering from chronic spontaneous urticaria (CSU) inadequately controlled by H1-antihistamines in comparison to placebo.","other_id":"CLOU064A2302","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Signed informed consent must be obtained prior to participation in the study.\r\n\r\n          -  Male and female adult participants 18 years of age at the time of screening.\r\n\r\n          -  CSU duration for  6 months prior to screening (defined as the onset of CSU determined\r\n             by the investigator based on all available supporting documentation).\r\n\r\n          -  Diagnosis of CSU inadequately controlled by second generation H1-antihistamines at the\r\n             time of randomization defined as:\r\n\r\n          -  The presence of itch and hives for 6 consecutive weeks prior to screening despite the\r\n             use of second generation H1-antihistamines during this time period\r\n\r\n          -  UAS7 score (range 0-42) 16, ISS7 score (range 0-21)  6 and HSS7 score (range 0-21) \r\n             6 during the 7 days prior to randomization (Day 1)\r\n\r\n          -  Documentation of hives within three months before randomization (either at screening\r\n             and/or at randomization; or documented in the participants medical history).\r\n\r\n          -  Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for the duration\r\n             of the study and adhere to the study protocol.\r\n\r\n          -  Participants must not have had more than one missing UPDD entry (either morning or\r\n             evening) in the 7 days prior to randomization (Day 1).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Participants having a clearly defined predominant or sole trigger of their chronic\r\n             urticaria (CU) (chronic inducible urticaria (CINDU)) including urticaria factitia\r\n             (symptomatic dermographism), cold-, heat-, solar-, pressure-, delayed pressure-,\r\n             aquagenic-, cholinergic-, or contact-urticaria\r\n\r\n          -  Other diseases with symptoms of urticaria or angioedema, including but not limited to\r\n             urticaria vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis,\r\n             hereditary urticaria, or drug-induced urticaria\r\n\r\n          -  Any other skin disease associated with chronic itching that might influence in the\r\n             investigator's opinion the study evaluations and results, e.g. atopic dermatitis,\r\n             bullous pemphigoid, dermatitis herpetiformis, senile pruritus or psoriasis\r\n\r\n          -  Evidence of clinically significant cardiovascular (such as but not limited to\r\n             myocardial infarction, unstable ischemic heart disease, New York heart association\r\n             (NYHA) Class III/IV left ventricular failure, arrhythmia and uncontrolled hypertension\r\n             within 12 months prior to Visit 1), neurological, psychiatric, pulmonary, renal,\r\n             hepatic, endocrine, metabolic, hematological disorders, gastrointestinal disease or\r\n             immunodeficiency that, in the investigator's opinion, would compromise the safety of\r\n             the participant, interfere with the interpretation of the study results or otherwise\r\n             preclude participation or protocol adherence of the participant\r\n\r\n          -  Significant bleeding risk or coagulation disorders\r\n\r\n          -  History of gastrointestinal bleeding, e.g. in association with use of nonsteroidal\r\n             anti-inflammatory drugs (NSAID), that was clinically relevant (e.g. requiring\r\n             hospitalization or blood transfusion)\r\n\r\n          -  Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100\r\n             mg/d or clopidogrel. The use of dual anti-platelet therapy (e.g. acetylsalicylic acid\r\n             + clopidogrel) is prohibited.\r\n\r\n          -  Requirement for anticoagulant medication (for example, warfarin or Novel Oral\r\n             Anti-Coagulants (NOAC))\r\n\r\n          -  History or current hepatic disease including but not limited to acute or chronic\r\n             hepatitis, cirrhosis or hepatic failure or Aspartate Aminotransferase (AST)/ Alanine\r\n             Aminotransferase (ALT) levels of more than 1.5 x upper limit of normal (ULN) or\r\n             International Normalized Ratio (INR) of more than 1.5 at screening\r\n      ","sponsor":"Novartis Pharmaceuticals","sponsor_type":"Industry","conditions":"Chronic Spontaneous Urticaria","interventions":[{"intervention_type":"Drug","name":"Drug: LOU064 (blinded)","description":"LOU064 (blinded) active treatment"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo"},{"intervention_type":"Drug","name":"Drug: LOU064 (open-label)","description":"LOU064 (open -label) active treatment"}],"outcomes":[{"outcome_type":"primary","measure":"Change from baseline in UAS7 (Scenario 1 with UAS7 as primary efficacy endpoint)","time_frame":"12 weeks","description":"To demonstrate that remibrutinib is superior to placebo in CSU with respect to change from baseline in UAS7 at Week 12 by assessing absolute change from baseline in UAS7 at Week 12.\r\nTo demonstrate that remibrutinib is superior to placebo in CSU with respect to change from baseline in UAS7 at Week 12 by assessing absolute change from baseline in weekly Urticaria Activity Score (UAS7) at week 12.\r\nThe UAS7 is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0"},{"outcome_type":"primary","measure":"Absolute change in ISS7 an absolute change in HSS7 (Scenario 2 with ISS7 and HSS7 as co-primary efficacy endpoints)","time_frame":"12 weeks","description":"To demonstrate that remibrutinib is superior to placebo in CSU with respect to change from baseline in ISS7 and HSS7 at Week 12 by assessing absolute change from baseline in ISS7 an HSS7 at Week 12.\r\nTo demonstrate that remibrutinib is superior to placebo in CSU with respect to change from baseline in ISS7 and HSS7 at Week 12 by assessing absolute change from baseline in weekly Itch Severity Score (ISS7) and weekly Hive Severity Score (HSS7) at week 12. The ISS7 and HSS7 combined together make up the UAS7 scoring system to evaluate urticaria signs and symptoms. The HSS7 score is the wheal/hives severity score for 7 days and the ISS7 is the itch severity score for 7 days, both these scores range from 0 to 21."},{"outcome_type":"secondary","measure":"Change from baseline in UAS7 (only in scenario 2)","time_frame":"12 weeks","description":"To demonstrate that remibrutinib is superior to placebo in CSU with respect to change from baseline in UAS7 at Week 12 by assessing absolute change in baseline in UAS7 at week 12."},{"outcome_type":"secondary","measure":"Disease activity control (UAS7 ≤ 6)","time_frame":"12 weeks","description":"To demonstrate that a greater proportion of participants achieve disease activity control (UAS7 ≤ 6) at Week 12 who are treated with remibrutinib compared to placebo-treated participants by achievement of UAS7 ≤ 6 at Week 12"},{"outcome_type":"secondary","measure":"Complete absence of hives and itch (UAS7 = 0)","time_frame":"12 weeks","description":"To demonstrate that a greater proportion of participants achieve complete absence of hives and itch (UAS7 = 0) at Week 12 who are treated with remibrutinib compared to placebo-treated participants by achievement of UAS7 = 0 at week 12"},{"outcome_type":"secondary","measure":"Reduction in weekly ISS score (only in scenario 1)","time_frame":"12 weeks","description":"To demonstrate the superiority of remibrutinib treated participants with respect to a reduction from baseline in the weekly itch severity score at Week 12 compared to placebo-treated participants by assessing the absolute change from baseline in ISS7 score at week 12."},{"outcome_type":"secondary","measure":"Reduction of weekly HSS score (only in scenario 1)","time_frame":"12 weeks","description":"To demonstrate the superiority of remibrutinib treated participants with respect to a reduction from baseline in the weekly hive severity score at Week 12 compared to placebo-treated participants assessed by the absolute change from baseline in HSS7 score at Week 12"},{"outcome_type":"secondary","measure":"Early onset of disease activity control","time_frame":"2 weeks","description":"To demonstrate that a greater proportion of participants achieve UAS7 ≤ 6 at Week 2 who are treated with remibrutinib compared to placebo-treated participants by assessing achievement of UAS7 ≤ 6 at Week 2"},{"outcome_type":"secondary","measure":"Achievement of DLQI = 0-1","time_frame":"12 weeks","description":"To demonstrate that a greater proportion of participants who are treated with remibrutinib achieve DLQI = 0-1 at Week 12 compared to placebo-treated participants by assessing achievement of DLQI = 0-1 at Week 12"},{"outcome_type":"secondary","measure":"Sustained disease activity control (UAS7 ≤ 6)","time_frame":"12 weeks","description":"To demonstrate that remibrutinib treated participants maintain disease activity control (defined as UAS7 ≤ 6) for more weeks compared to placebo treated participants over 12 weeks by assessing cumulative number of weeks with an UAS7 ≤ 6 response between baseline and Week 12"},{"outcome_type":"secondary","measure":"Number of weeks without angiodema (AAS7 = 0)","time_frame":"12 weeks","description":"To demonstrate that remibrutinib treated participants have more angioedema occurrence-free weeks over 12 weeks compared with placebo-treated participants by assessing the cumulative number of weeks with an AAS7 = 0 response between baseline and Week 12"},{"outcome_type":"secondary","measure":"Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability of remibrutinib]","time_frame":"56 weeks","description":"To demonstrate the safety and tolerability of remibrutinib by assessing occurrence of treatment emergent adverse events and serious adverse events during the study."}]}
{"nct_id":"NCT04471142","start_date":"2021-11-08","phase":"N/A","enrollment":270,"brief_title":"Effectiveness of Compressive Bandage Use in Seroma Prevention","official_title":"Effectiveness of Compressive Bandage Use in Post-Treatment Seroma Prevention Breast Cancer Surgery","primary_completion_date":"2022-06-30","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2023-03-30","last_update":"2021-09-21","description":"INTRODUCTION: Seroma is the most common complication after surgical treatment for breast cancer. It is the abnormal accumulation of serous fluid that develops under skin flaps and may be associated with necrosis, dehiscence, sepsis, and shoulder dysfunction. The therapeutic bandage has been inserted in clinical practice because it is similar to the elasticity of the skin and is able to help the circulatory and lymphatic system, reduce pain and local swelling, and may have benefits for prevention and treatment of seroma when applied compressively. . OBJECTIVE: To evaluate the effectiveness of compressive bandage in preventing seroma. METHODOLOGY: Randomized study of women over 18 years who underwent mastectomy at HCIII / INCA. Eligible patients will be allocated to the intervention and control groups by lot (270 envelopes, 135 patients per group). The intervention group, in addition to the use of the drain, will be submitted to the compression bandage on the day of hospital discharge and will be reevaluated on the seventh day. The control group will follow the institutional routine, using only the drain. The incidence and volume of the seroma, as well as the length of stay of the drain will be evaluated after 30 days through the medical record. Symptoms and skin changes resulting from the use of the bandage will be evaluated through a specific form. ANALYSIS: Descriptive analysis will be by measures of central tendency, dispersion and frequency distribution. Outcome assessment will be performed by odds ratio (for categorical variables) and by mean difference (Student's t-test), considering a 95% confidence interval. To control the confounding variables, multiple logistic regression (categorical outcome) and multiple linear regression (continuous outcome) will be performed by the Stepwise Forward method, including variables with p <0.20.","other_id":"Instituto Nacional do Cncer","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","intervention_model_description":"All patients undergoing mastectomy will be evaluated for eligibility criteria after the first dressing, those considered eligible will be randomized to the intervention or control group. 27 blocks will be available containing 10 envelopes where 05 will contain a code that allocates the patients in group A and 05 in group B. Group A: intervention group with preventive application of compressive bandage in addition to the suction drain (routine adopted in the institution). The bandage will be applied on the day of discharge after the first dressing, withdrawal and new bandage applied on the fourth day and permanently removed on the seventh day when they will be reevaluated. Group B: control group. Patient will follow the routine of the institution only with the suction drain.","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Women aged 18 and over\r\n\r\n          -  underwent mastectomy assurgical treatment for breast cancer.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  bilateral breast cancer;\r\n\r\n          -  patient undergoing neoadjuvant radiotherapy;\r\n\r\n          -  infection in the surgical wound or hematoma;\r\n\r\n          -  autoimmune disease reporting (dermatomyositis, hidradenitis suppurativa, nephropathy,\r\n             lupus erythematosus, morphea, psoriasis, pemphigus vulgaris, scleroderma);\r\n\r\n          -  patients with difficulties in understanding.\r\n      ","sponsor":"Instituto Nacional de Cancer, Brazil","sponsor_type":"Other","conditions":"Seroma","interventions":[{"intervention_type":"Device","name":"Device: neuromuscular bandage","description":"After the dressing is performed by the nursing team with a sterile gauze covering over the region of the healing points, the 7 cm wide Vitaltape neuromuscular bandage will be applied. For the application of the bandage, maximum stretching will be performed over the region of the plastron and finished with the two ends, from two to three centimeters, without stretching. As many bundles of bandages as necessary will be applied according to the patient's body characteristics."}],"outcomes":[{"outcome_type":"primary","measure":"Seroma Incidence","time_frame":"30 days","description":"the presence of assessed local fluctuation will be considered seroma by the nursing team during dressing care, with indication of puncture aspiration to resolve the condition, regardless of the volume drained."},{"outcome_type":"primary","measure":"Seroma volume","time_frame":"30 days","description":"the total volume drained and the number of aspirations will be considered necessary until resolution of the picture."},{"outcome_type":"primary","measure":"Permanence time with the Suction Drain","time_frame":"15 days","description":"The permanence time (in days) will be checked with the suction drain, as reported by the dressing team."},{"outcome_type":"secondary","measure":"Safety of the use of the compressive bandage in mastectomized women","time_frame":"7 days","description":"The dermal changes will be evaluated at the location of the bandage application of the 135 participants in the intervention group, such as discoloration, increased local temperature, skin peeling, presence of a wound and formation of bullous lesions at the site of the application of the neuromuscular bandage, graded in light, moderate or severe, according to the severity of the change, from a semi-structured questionnaire."},{"outcome_type":"secondary","measure":"To assess the tolerance reported by the patient to the use of compressive taping","time_frame":"7 days","description":"The symptoms of pain, itching, burning, discomfort, tightness, increased fluctuation of the seroma at the site of application of the bandage of the 135 participants will be evaluated. The symptoms will be graded according to the Visual Numeric Scale (0-10), where 0 will be considered no sensation and 10 unbearable sensation with the use of the bandage."}]}
{"nct_id":"NCT04772651","start_date":"2021-11-01","phase":"N/A","enrollment":108,"brief_title":"Mediterranean Diet and the Microbiota Gut Brain Axis in Major Depression","official_title":"Mediterranean Diet and the Microbiota Gut Brain Axis- Does Diet Interact With the Function of Vagal Nerve in Major Depression?","primary_completion_date":"2022-09-01","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2022-09-30","last_update":"2021-09-01","description":"The purpose of this study is to assess the efficacy of a Mediterranean diet on the function of the vagal nerve in patients with depression.","other_id":"EK 1087 ex 2021","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  legally competent persons aged 18-80 years\r\n\r\n          -  diagnosis of depression according to ICD-10 or DSM.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  other neurologic or psychiatric disorders (epilepsy, brain tumor, head injury, head\r\n             surgery, trauma)\r\n\r\n          -  drug or alcohol dependency\r\n\r\n          -  acute suicidality\r\n\r\n          -  heart disorders, disorders of the circulatory system\r\n\r\n          -  pregnancy and period of breastfeeding\r\n\r\n          -  severe mental disability, dementia (MMST<20)\r\n\r\n          -  autoimmune disorder, severe immunosuppression (Lupus, HIV, multiple sclerosis)\r\n\r\n          -  therapy with antibiotics in the last month\r\n\r\n          -  chronic laxative abuse\r\n\r\n          -  acute infectious diarrhea\r\n\r\n          -  GI surgeries (except appendectomy)\r\n\r\n          -  regular intake of probiotics, antibiotics and food supplements (1 month before and\r\n             during the study)\r\n\r\n          -  food allergies or other food intolerances which are incompatible with a mediterranean\r\n             diet\r\n\r\n          -  vegetarians, vegans\r\n      ","sponsor":"Medical University of Graz","sponsor_type":"Other","conditions":"Depression","interventions":[{"intervention_type":"Other","name":"Other: Mediterranean Diet","description":"Diet meeting the requirements for mediterranean style (rich in vegetables, fruit, olive oil, fish) (Davis et al., 2015)"},{"intervention_type":"Other","name":"Other: Normal hospital diet","description":"Normal hospital diet"},{"intervention_type":"Other","name":"Other: dietary coaching","description":"dietary coaching"},{"intervention_type":"Other","name":"Other: Psychoeducation on depression","description":"Psychoeducation on depression (50minutes once a week for 4 weeks)"}],"outcomes":[{"outcome_type":"primary","measure":"Change in Vagal function","time_frame":"at study entry, after 7 days, after 4 weeks and after 3 months","description":"Vagal function measured by 24-hr ECG (logRSA, SDNN)"},{"outcome_type":"secondary","measure":"Change of C-reactive protein (CRP)","time_frame":"at study entry, after 7 days, after 4 weeks and after 3 months","description":"CRP will be measured from serum samples at the Institute of laboratory diagnostics (Cobas analyzer)"},{"outcome_type":"secondary","measure":"Change in Interleukine-6","time_frame":"at study entry, after 7 days, after 4 weeks and after 3 months","description":"Interleukine-6 will be measured from serum samples at the Institute of laboratory diagnostics"},{"outcome_type":"secondary","measure":"Change in Oxytocin","time_frame":"at study entry, after 7 days, after 4 weeks and after 3 months","description":"measured from serum samples with ELISA"},{"outcome_type":"secondary","measure":"Change of Gut microbiome","time_frame":"at study entry, after 7 days, after 4 weeks and after 3 months","description":"16S sequencing of a stool sample, gut microbiome data will be analyzed with QIIME2 with regard to diversity metrices (alpha-diversity, beta-diversity) and differential bacterial abundance."},{"outcome_type":"secondary","measure":"Change of Body mass Index","time_frame":"at study entry, after 7 days, after 4 weeks and after 3 months","description":"Weight will be measured with a calibrated scale, height will be measured with a non-expandable measuring tape. BMI will be calculated according to the formula [kg/m2]."},{"outcome_type":"secondary","measure":"Change in Hamilton Scale for Depression (HAMD)","time_frame":"at study entry, after 7 days, after 4 weeks and after 3 months","description":"Scale to rate severity of depressive symptoms; Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression"},{"outcome_type":"secondary","measure":"Change in Beck Depression Inventory (BDI)","time_frame":"at study entry, after 7 days, after 4 weeks and after 3 months","description":"Self-rated scale to rate severity of depressive symptoms; Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depression."},{"outcome_type":"secondary","measure":"Change in Pittsburgh Sleep Quality Inventory (PSQI)","time_frame":"at study entry, after 7 days, after 4 weeks and after 3 months","description":"Questionnaire to assess sleep quality; global PSQI score is calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality."},{"outcome_type":"secondary","measure":"Change in Adult Attachment Scale","time_frame":"at study entry, after 7 days, after 4 weeks and after 3 months","description":"Questionnaire to assess attachment style in adults; The scale consists of 18 items scored on a 5 point likert-type scale. It measures adult attachment styles named \"Secure\", \"Anxious\" and \"Avoidant\", defined as:\r\nSecure = high scores on Close and Depend subscales, low score on Anxiety subscale\r\nAnxious = high score on Anxiety subscale, moderate scores on Close and Depend subscales\r\nAvoidant = low scores on Close, Depend, and Anxiety subscales"},{"outcome_type":"secondary","measure":"Change in Wiener Ernährungsprotokoll","time_frame":"at study entry, after 7 days, after 4 weeks and after 3 months","description":"24-hr food recall"},{"outcome_type":"secondary","measure":"Change in Mediterranean Diet Score","time_frame":"at study entry, after 7 days, after 4 weeks and after 3 months","description":"Questionnaire rating the diet according to Mediterranean dietary style; three categories of adherence to the Mediterranean diet can be calculated (≤5, 6-9 and ≥10 points of the 14-item questionnaire)"},{"outcome_type":"secondary","measure":"Change in International Physical Acitivity Questionnaire","time_frame":"at study entry, after 7 days, after 4 weeks and after 3 months","description":"Questionnaire to rate physical activity; Physical activity is given in MET-minutes (METs are multiples of the resting metabolic rate)"}]}
{"nct_id":"NCT04390451","start_date":"2021-11-01","phase":"Phase 1","enrollment":54,"brief_title":"Initial Testing of Whole Health STEPS","official_title":"Initial Testing of Whole Health STEPS (Structured Tiered Engagement With Peer Support)","primary_completion_date":"2024-06-30","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2024-06-30","last_update":"2021-09-02","description":"This clinical trial is evaluating Whole Health STEPS (Structured Tiered Engagement with Peer Support), a package of services designed to improve functional outcomes for primary care Veterans with mental health concerns who are not actively engaged in mental health services. Whole Health STEPS uses a Peer Support Specialist, or Peer, to provide support for Veterans to make progress on wellness goals using the Whole Health model. The level of support provided will be determined based on Veterans' progress and will be stepped-up until Veterans receive the level of support they need. Whole Health STEPS offers a non-mental health referral option for primary care Veterans with mental health concerns, provides a structured package of existing Whole Health services, and provides a structured service for peers in primary care settings.","other_id":"D3390-W","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","intervention_model_description":"The study compares Whole Health STEPS to a waitlist control.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Veteran status\r\n\r\n          -  Enrolled in primary care at a participating site\r\n\r\n          -  Have at least mild functional impairment\r\n\r\n          -  Screen positive on at least one primary care mental health screener\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Actively engaged with an equivalent or higher level of care\r\n\r\n          -  Preference for direct referral to mental health care\r\n\r\n          -  Recent changes to psychotropic medications\r\n\r\n          -  Severe impairment preventing engagement in the intervention or warranting a direct\r\n             referral to a licensed independent provider\r\n\r\n          -  Inability to independently communicate in verbal and written English\r\n\r\n          -  Inability to complete the research tasks or intervention\r\n      ","sponsor":"VA Office of Research and Development","sponsor_type":"U.S. Fed","conditions":"Mental Health","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Whole Health STEPS","description":"A peer-delivered package of Whole Health services."}],"outcomes":[{"outcome_type":"primary","measure":"Inventory of Psychosocial Functioning (IPF)","time_frame":"4 months","description":"This 80 item self-report inventory measures several domains of psychosocial functioning (e.g., family relationships, work, self-care) on a 0-100 scale with lower scores indicating better outcomes."}]}
{"nct_id":"NCT04696861","start_date":"2021-11-01","phase":"N/A","enrollment":60,"brief_title":"Telehealth to Reduce Suicidality and Improve HIV Care Engagement in Tanzania","official_title":"Telehealth to Reduce Suicidality and Improve HIV Care Engagement in Tanzania","primary_completion_date":"2025-03-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2025-03-31","last_update":"2021-09-20","description":"The overall objectives of the proposed research are to develop a brief telehealth counseling intervention to provide support for people living with HIV and experiencing suicidal ideation, and to support HIV care engagement. The investigators hypothesize that a brief telehealth counseling intervention will be safe (participants in the clinical trial will not have increased risk of suicidal behavior), acceptable (high patient retention and satisfaction, high fidelity), and will demonstrate preliminary efficacy (reduced suicidal ideation, improved care engagement, improved mental well-being).","other_id":"Pro00107424","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Patients who screen positive for suicidal ideation will be enrolled in the study, complete the baseline survey, and then randomly assigned to the intervention (3 sessions of counseling) or enhanced standard of care (brief safety planning).","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18 years of age or older\r\n\r\n          -  Attending HIV care at study clinic\r\n\r\n          -  Screen positive for suicidal ideation\r\n\r\n          -  Able to understand Kiswahili or English\r\n\r\n          -  Medically stable\r\n\r\n          -  Capable of providing informed consent to participate\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Under 18 years old\r\n\r\n          -  Unable to understand Kiswahili or English\r\n\r\n          -  Experiencing medical or psychiatric symptoms requiring immediate treatment\r\n\r\n          -  Incapable of providing informed consent to participate\r\n      ","sponsor":"Duke University","sponsor_type":"Other","conditions":"Suicide|Suicidal Ideation|HIV Infections|Adherence, Medication|Treatment Adherence and Compliance|Stigma, Social|Disclosure|Quality of Life","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: IDEAS for Hope","description":"Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement."},{"intervention_type":"Behavioral","name":"Behavioral: Enhanced Standard of Care (Safety Planning)","description":"Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning."}],"outcomes":[{"outcome_type":"secondary","measure":"HIV Disclosure","time_frame":"3 months post enrollment","description":"Self-reported disclosure to partner, family, friends, others (yes/no) and total number of disclosures"},{"outcome_type":"primary","measure":"Suicidal Ideation","time_frame":"3 months post enrollment","description":"Columbia-Suicide Severity Rating Scale (C-SSRS), 6 items, scale 0 to 6 with higher indicating more ideation"},{"outcome_type":"primary","measure":"HIV Care Engagement","time_frame":"3 months post enrollment","description":"Self-reported clinic attendance"},{"outcome_type":"primary","measure":"HIV Medication Adherence","time_frame":"3 months post enrollment","description":"Self-reported medication adherence"},{"outcome_type":"secondary","measure":"Depression","time_frame":"3 months post enrollment","description":"Patient Health Questionnaire (PHQ-9), 9 items, score 0-27 with higher indicating more depression"},{"outcome_type":"secondary","measure":"HIV Stigma","time_frame":"3 months post enrollment","description":"HIV Stigma Scale (HSS), 12 items, score 12-48 with higher indicating more stigma"},{"outcome_type":"secondary","measure":"HIV Acceptance","time_frame":"3 months post enrollment","description":"Illness Cognition Questionnaire (ICQ), 6 items, score 0-18 with higher indicating more acceptance"},{"outcome_type":"secondary","measure":"Social Support","time_frame":"3 months post enrollment","description":"Perceived Availability of Support Scale (PASS), 7 items, score 7 to 35 with higher indicating more social support"},{"outcome_type":"secondary","measure":"Attitudes About Antiretroviral Therapy","time_frame":"3 months post enrollment","description":"Beliefs About Medicine Questionnaire (BMQ), 10 items, score 10 to 50 with higher indicating more positive attitudes about medication"},{"outcome_type":"secondary","measure":"Acceptability of Intervention","time_frame":"3 months post enrollment","description":"10 items adapted from the Client Satisfaction Questionnaire (CSQ), score 10 to 40 with higher indicating greater satisfaction with the intervention"},{"outcome_type":"secondary","measure":"Suicide Coping Self-Efficacy","time_frame":"3 months post enrollment","description":"Self-Efficacy to Avoid Suicidal Action (SEASA) Scale, 6 items, score 0 to 60 with higher indicating more coping self-efficacy"},{"outcome_type":"secondary","measure":"Hopelessness","time_frame":"3 months post enrollment","description":"Beck Hopelessness Scale (Balsamo Short Form), 9 items, score 0 to 9 with higher indicating more hopelessness"},{"outcome_type":"secondary","measure":"Reasons for Living","time_frame":"3 months post enrollment","description":"Brief Reasons for Living Inventory, 12 items, score 12 to 72 with higher indicating more reasons to live"},{"outcome_type":"secondary","measure":"Anxiety","time_frame":"3 months post enrollment","description":"Brief Symptom Inventory Anxiety Subscale, 6 items, score 0 to 24 with higher indicating more anxiety"},{"outcome_type":"secondary","measure":"Quality of Life (Overall and Health Satisfaction)","time_frame":"3 months post enrollment","description":"WHOQOL-BREF, 2 items, score 2 to 10 with higher indicating better quality of life"}]}
{"nct_id":"NCT03954431","start_date":"2021-10-31","phase":"Phase 1/Phase 2","enrollment":100,"brief_title":"High-Resolution Lower Dose Dedicated Breast Computed Tomography (CT)","official_title":"Study of High-resolution, Lower Dose Dedicated Breast CT for Visualization and Diagnosis of Breast Imaging Reporting And Data System (BIRADS) 4/5 Findings.","primary_completion_date":"2022-10-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2023-10-31","last_update":"2021-09-16","description":"This study is being performed to find out if a new kind of breast imaging (called contrast-media enhanced breast CT or CE-BCT) can help doctors to see the small structures in breast tissue more clearly. This study is also being performed to find out if using the CE-BCT will separate cancers from non-cancers. This is important because 25% to 35% of structures that do not appear to be normal and are removed from the breast (biopsied) for studying under a microscope turn out to be cancer.","other_id":"1903399639","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":40,"population":"","criteria":"\n        Inclusion criteria:\r\n\r\n          -  who were asymptomatic and 40 years of age or older (typical screening age range) at\r\n             the time of the screening exam that prompted the recall\r\n\r\n          -  who were assigned BI-RADS category 4 or 5 after x-ray based diagnostic work-up such as\r\n             mammography or digital breast tomosynthesis (DBT)\r\n\r\n          -  who have no known adverse reaction to iodinated contrast media\r\n\r\n          -  who satisfy University of Arizona (UA) - Banner University Medical Center (BUMC),\r\n             Department of Medical Imaging policy for administration of iodinated contrast media\r\n             for computed tomography (CT) imaging, which may include a blood draw for renal\r\n             function assessment.\r\n\r\n        Exclusion criteria:\r\n\r\n          -  Males,\r\n\r\n          -  women less than 40 years old,\r\n\r\n          -  women unable to self-consent,\r\n\r\n          -  prisoners,\r\n\r\n          -  pregnant or lactating women (If premenopausal, urine pregnancy test will be used to\r\n             determine pregnancy)\r\n\r\n          -  women with physical limitations that may prohibit resting prone on the exam table,\r\n             such as, but not limited to: frozen shoulder, recent heart surgery, pace maker;\r\n\r\n          -  women who are unable to tolerate study constraints, frail, or unable to cooperate;\r\n\r\n          -  women who weigh more than 440 lbs (200 Kg), which is the weight limit for the patient\r\n             support table of the BCT system;\r\n\r\n          -  women who have received radiation treatments to the thorax for malignant and\r\n             nonmalignant conditions, such as (but not limited to) treatment for enlarged thymus\r\n             gland as an infant, irradiation for benign breast conditions, including breast\r\n             inflammation after giving birth, and treatment for Hodgkin's disease;\r\n\r\n          -  women who have participated in a prior breast clinical trial that gave additional\r\n             radiation dose, such as an additional mammogram;\r\n\r\n          -  women with glomerular filtration rate (GFR) less than 30 mL/min/1.73 m^2 indicative of\r\n             impaired kidney function,\r\n\r\n          -  women with known allergies to contrast media,\r\n\r\n          -  women who have received large number of diagnostic x-ray examinations for monitoring\r\n             of disease such as (but not limited to) tuberculosis, and severe scoliosis.\r\n      ","sponsor":"University of Arizona","sponsor_type":"Other","conditions":"Breast Cancer","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Contrast-media enhanced breast CT(CE-BCT)","description":"The breast CT device will take multiple pictures of the subject's breast and create a 3-D image of the breast."},{"intervention_type":"Drug","name":"Drug: Iodinated Contrast Agent","description":"The CE-BCT diagnostic test will use an iodinated contrast agent. This drug is FDA approved for contrast-enhanced x-ray imaging examinations, though not specifically for dedicated breast computed tomography."}],"outcomes":[{"outcome_type":"primary","measure":"Lesion conspicuity","time_frame":"18 months","description":"The conspicuity of lesions will be evaluated using CE-BCT."},{"outcome_type":"secondary","measure":"Contrast enhancement quantification","time_frame":"18 months","description":"The amount of contrast enhancement with CE-BCT will be quantified."}]}
{"nct_id":"NCT04273022","start_date":"2021-10-31","phase":"N/A","enrollment":20,"brief_title":"Effect of Exercise on Biomarkers in SCT","official_title":"The Effect of Exercise on Resting Biomarkers in Subjects With Sickle Cell Trait","primary_completion_date":"2022-08-01","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2022-08-01","last_update":"2021-09-13","description":"This study measures the effect of exercise on a variety of biomarkers in blood and urine selected to evaluate the physiological pathways of hemolysis, myolysis, thrombosis, inflammation, and renal function in subjects with sickle cell trait. These pathways have been shown to be associated with adverse events in athletes and warfighters with SCT upon protracted, repeated, strenuous exertion. Changes in biomarkers post-exercise compared to pre-exercise (and compared to healthy controls) suggest activation of the associated pathway(s) which may contribute to exercise-related events in athletes and warfighters and subclinical complications in non-athletes.","other_id":"30577","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"Single","intervention_model_description":"SCT subjects will be evaluated for activation of five physiological pathways by measuring 15 biomarkers before and after a single bout of moderate exercise. The control group will confirm normal biomarkers at rest and determine the natural response to moderate exercise.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria: Sickle Cell Trait Group (AS)\r\n\r\n          -  Health subjects with sickle cell trait (AS)\r\n\r\n          -  Ages 18-70 years\r\n\r\n        Inclusion Criteria: Control group (AA)\r\n\r\n          -  Healthy subjects without sickle cell trait (AA)\r\n\r\n          -  Ages 18-70 years\r\n\r\n        Exclusion Criteria: Sickle Cell Trait group (AS) AND healthy controls (AA).\r\n\r\n        Subjects will be excluded if they:\r\n\r\n          -  weigh less than 110 pounds,\r\n\r\n          -  are pregnant,\r\n\r\n          -  have hemoglobinopathies (other than sickle cell trait) as determined by Hb\r\n             electrophoresis,\r\n\r\n          -  have other self-reported conditions known to cause blood coagulation activation,\r\n             myocyte destruction, hemolysis, chronic inflammation, or renal disease\r\n\r\n          -  any condition that places subjects at risk during exercise.\r\n      ","sponsor":"St. Louis University","sponsor_type":"Other","conditions":"Sickle Cell Trait","interventions":[{"intervention_type":"Other","name":"Other: Exercise","description":"A single bout of standardized, moderate exercise"}],"outcomes":[{"outcome_type":"primary","measure":"Change in reticulocyte count","time_frame":"Immediately before, immediately after, & 24 hours after a single bout of submaximal exercise on a treadmill","description":"Reticulocytes will be counting using a manual microscopic method (New Methylene Blue) from blood collected in EDTA and reported as percentage of reticulocytes per 100 erythrocytes. Elevated reticulocytes suggest the bone marrow response to hemolysis."},{"outcome_type":"primary","measure":"Change in erythrocyte morphology amounts","time_frame":"Immediately before, immediately after, & 24 hours after a single bout of submaximal exercise on a treadmill","description":"Blood collected in EDTA will be smeared on a microscope slide, stained with Wright stain, and analyzed for abnormal morphologic forms with a particular interest in sickle cells. Each abnormal erythrocyte morphologic form will be reported on a Likert scale from 1-4+ as follows: 1+ (few abnormal cells); 2+ (approximately 1/3 abnormal cells); 3+ (approximately 1/2 abnormal cells); 4+ (>1/2 abnormal cells). Increasing numbers of sickle cells in response to exercise may be associated with increased hemolysis, myocyte destruction, inflammation, initiation of coagulation, and renal dysfunction."},{"outcome_type":"primary","measure":"Change in haptoglobin level","time_frame":"Immediately before, immediately after, & 24 hours after a single bout of submaximal exercise on a treadmill","description":"Haptoglobin will be measured on serum collected in a clot tube and reported as mg/dL (milligrams/deciliter) using a radial immunodiffusion method. Low haptoglobin levels suggest intravascular hemolysis."},{"outcome_type":"primary","measure":"Change in potassium (K+) level","time_frame":"Immediately before, immediately after, & 24 hours after a single bout of submaximal exercise on a treadmill","description":"Potassium will be measured in serum collected in a clot tube, analyzed by ion selective electrode, and reported in mEq/L (milliequivalents/liter) or mmole/L (millimoles/liter). Elevated potassium levels suggest intravascular hemolysis."},{"outcome_type":"primary","measure":"Change in creatine kinase (CK) level","time_frame":"Immediately before, immediately after, & 24 hours after a single bout of submaximal exercise on a treadmill","description":"Creatine kinase will be measured in serum from a clot tube, analyzed spectrophotometrically by enzyme kinetics and reported in U/L (units [of enzyme activity]/liter. Elevated creating kinase levels suggest myocyte destruction in the post-exercise environment."},{"outcome_type":"primary","measure":"Change in serum myoglobin level","time_frame":"Immediately before, immediately after, & 24 hours after a single bout of submaximal exercise on a treadmill","description":"Myoglobin will be measured in urine, analyzed by electrochemiluminescent Immunoassay or nephelometry and reported in ng/mL (nanograms/milliliter). Elevated myoglobin suggests myocyte destruction."},{"outcome_type":"primary","measure":"Change in urine myoglobin level","time_frame":"Immediately before, immediately after, & 24 hours after a single bout of submaximal exercise on a treadmill","description":"Myoglobin will be measured in urine, analyzed by electrochemiluminescent immunoassay or nephelometry and reported in mg/L (milligrams/liter). Elevated myoglobin suggests myocyte destruction."},{"outcome_type":"primary","measure":"Change in D-dimer level","time_frame":"Immediately before, immediately after, & 24 hours after a single bout of submaximal exercise on a treadmill","description":"D-dimer will be measured in citrated plasma, analyzed by immunoturbidimetry and reported in ug/mL (micrograms/milliliter). Elevated D-dimer suggests the initiation of abnormal clotting or an inflammatory reaction."},{"outcome_type":"primary","measure":"Change in fibrin monomer level","time_frame":"Immediately before, immediately after, & 24 hours after a single bout of submaximal exercise on a treadmill","description":"Fibrin monomer will be measured in citrated plasma, analyzed by the hemeagglutination method, and reported as negative (normal) or positive (abnormal). Elevated fibrin monomers suggest the initiation of coagulation."},{"outcome_type":"primary","measure":"Change in antithrombin III (ATIII) level","time_frame":"Immediately before, immediately after, & 24 hours after a single bout of submaximal exercise on a treadmill","description":"Antithrombin III will be measured in serum from a clot tube, analyzed by radial immunodiffusion, and reported in mg/dL (milligrams/deciliter). Low antithrombin III levels suggest the initiation of coagulation."},{"outcome_type":"primary","measure":"Change in C-reactive protein (CRP) level","time_frame":"Immediately before, immediately after, & 24 hours after a single bout of submaximal exercise on a treadmill","description":"C-reactive protein will be measured in serum from a clot tube, analyzed by radial immunodiffusion, and reported in mg/dL (milligrams/deciliter). Elevated C-reactive protein suggest an inflammatory reaction."},{"outcome_type":"primary","measure":"Change in erythrocyte sedimentation rate (ESR) level","time_frame":"Immediately before, immediately after, & 24 hours after a single bout of submaximal exercise on a treadmill","description":"Erythrocyte sedimentation rate will be measured on whole blood collected in EDTA using the Wintrobe method and reported in mm/hr (millimeters/hour). An elevated erythrocyte sedimentation rate suggests an inflammatory reaction."},{"outcome_type":"primary","measure":"Change in 11-dehydrothrombaxaneB2 (11-DTXB2) level","time_frame":"Immediately before, immediately after, & 24 hours after a single bout of submaximal exercise on a treadmill","description":"11-dehydrothromboxane B2 will be measured in urine using an enzyme-linked immunosorbant assay (ELISA) and will be reported as pg/mL of creatinine (picogram/milliliter of creatinine). 11-dehydrothrombozane B2 is a direct measure of platelet activation and an indirect measure of an inflammatory reaction."},{"outcome_type":"primary","measure":"Change in complete urinalysis results","time_frame":"Immediately before, immediately after, & 24 hours after a single bout of submaximal exercise on a treadmill","description":"A 10 parameter dipstick and a microscopic examination of urine will be performed on each urine sample collected. Each of the 10 dipstick parameters will be reported according to the package insert. We will pay particular attention to intact RBCs on the dipstick and sediment as an indicator of glomerular dysfunction, free hemoglobin as an indicator of hemolysis, elevated protein as an indicator of renal dysfunction or hemoglobinuria or myoglobinuria (hemolysis), and specific gravity interpreted in the context of blood and protein levels (and glucose) as an indicator of renal dysfunction."},{"outcome_type":"primary","measure":"Change in microalbumin level","time_frame":"Immediately before, immediately after, & 24 hours after a single bout of submaximal exercise on a treadmill","description":"Microalbumin will be measured in urine with a dipstick using the sulfonephthalein dye method as an indicator of renal dysfunction and reported in mg/L (millighrams/liter)."}]}
{"nct_id":"NCT04298567","start_date":"2021-10-28","enrollment":300,"brief_title":"Study to Learn More About the Effectiveness and Safety of Rivaroxaban (Xarelto) When Given Together With Acetylsalicylic Acid to Patients Suffering From a Condition That Affects the Blood Vessels Supplying the Heart (CAD) and/or a Condition That Affects the Blood Vessel of the Lower Limbs (PAD).","official_title":"A Phase IV Study to Investigate the Safety and Effectiveness of Rivaroxaban(Xarelto) 2.5mg [BID]+Acetylsalicylic Acid(ASA) 75mg [OD] in Indian Patients With Coronary and/or Symptomatic Peripheral Artery Disease","primary_completion_date":"2023-10-25","study_type":"Observational","rec_status":"Not yet recruiting","completion_date":"2023-11-22","last_update":"2021-09-05","description":"In this study researcher want to gather more information on the effectiveness and safety of Rivaroxaban(Xarelto) when given together with Acetylsalicylic Acid to patients suffering from coronary artery disease (a condition that affects the blood vessels supplying the heart) and / or peripheral artery disease (a condition that affects the blood vessel of the lower limbs) in the routine clinical practice in India. The study plans to enroll about 300 male or female patients who are at least 18 years old and are already on the treatment with the two drugs. Researchers are especially interested whether patients experience under treatment any events such as minor or major bleedings, stroke, sickness of the heart or blood vessels. In addition information on why and when treating doctors are deciding to start or stop the treatment with Rivaroxaban and Acetylsalicylic Acid are of interest for the researchers.","other_id":"21269","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Female and male patients with a diagnosis of CAD or symptomatic PAD will be enrolled within\r\n        4 weeks after the decision for treatment with rivaroxaban plus ASA has been made by the\r\n        investigator.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adult (18 years) patient.\r\n\r\n          -  Diagnosis of CAD or PAD.\r\n\r\n          -  Treatment with Rivaroxaban 2.5mg tablet, co administered with acetylsalicylic acid\r\n             (ASA), for the prevention of atherothrombotic events in adult patients with coronary\r\n             artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of\r\n             ischaemic events within 4 weeks prior to enrolment. also patients already on\r\n             rivaroxaban treatment for ACS, who are subsequently fulfilling criteria for CAD, are\r\n             allowed to be enrolled within 4 weeks of this decision being made.\r\n\r\n          -  Patients who are willing to participate in this study (signed informed consent).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Contra-indications according to the local marketing authorization.\r\n\r\n          -  Patients who will be treated with chronic anticoagulation therapy other than\r\n             rivaroxaban 2.5mg given for CAD/PAD.\r\n\r\n          -  Participation in an interventional trial.\r\n      ","sponsor":"Bayer","sponsor_type":"Industry","conditions":"Coronary Artery Disease(CAD)|Peripheral Artery Disease(PAD)","interventions":[{"intervention_type":"Drug","name":"Drug: Rivaroxaban (Xarelto,Bay 59-7939)","description":"Rivaroxaban (2.5 mg [BID])"},{"intervention_type":"Drug","name":"Drug: Acetylsalicylic acid(ASA)","description":"ASA (75mg [QD]; dose according to local label."}],"outcomes":[{"outcome_type":"secondary","measure":"Number of participants with peripheral revascularization procedures","time_frame":"Up to 13 months"},{"outcome_type":"secondary","measure":"Number of participants with carotid revascularization procedures","time_frame":"Up to 13 months"},{"outcome_type":"primary","measure":"Number of participants with haemorrhagic events and complications","time_frame":"Up to 13 months","description":"Consisting of minor and major bleeding events. The major bleeding complications are collected according to the International Society on Thrombosis and Haemostasis (ISTH) criteria as a composite of fatal bleeding, symptomatic bleeding into a critical organ (such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome), bleeding into surgical site requiring reoperation, bleeding leading to hospitalization."},{"outcome_type":"secondary","measure":"Number of participants with major adverse cardiovascular events (MACE)","time_frame":"Up to 13 months","description":"MACE: composite of MI, stroke, and cardiovascular death (and single components)"},{"outcome_type":"secondary","measure":"Number of participants with major adverse limb events (MALE)","time_frame":"Up to 13 months","description":"MALE: Major adverse limb events, incl. major amputation (and single components), and antithrombotic treatment patterns after MALE"},{"outcome_type":"secondary","measure":"Number of participants with thromboembolic events","time_frame":"Up to 13 months","description":"Thromboembolic events includes systemic embolism, venous thromboembolism"},{"outcome_type":"secondary","measure":"Number of participants with cardiovascular mortality","time_frame":"Up to 13 months"},{"outcome_type":"secondary","measure":"Number of participants with all-cause mortality","time_frame":"Up to 13 months"},{"outcome_type":"secondary","measure":"Number of participants with cardiac revascularization procedures","time_frame":"Up to 13 months","description":"Cardiac revascularization procedure includes Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Grafting (CABG)"},{"outcome_type":"secondary","measure":"Duration of hospitalizations","time_frame":"Up to 13 months","description":"Hospitalizations includes stroke, cardiovascular reasons, MALE, or bleeding complications."},{"outcome_type":"secondary","measure":"Total and pain free walking distance per individual for PAD patients","time_frame":"Change from baseline up to 13 months"},{"outcome_type":"secondary","measure":"Number of participants with history and diagnosis of CAD or PAD","time_frame":"Up to 13 months","description":"History and diagnosis of CAD, incl. history of myocardial infarction and vessel status.\r\nHistory and diagnosis of PAD, incl. ankle-brachial index (ABI)."},{"outcome_type":"secondary","measure":"Number of participants with individual risk","time_frame":"Up to 13 months","description":"Individual Risk classification: Co-morbidities (e.g. worsening symptoms, diabetes mellitus, chronic heart failure (CHF) renal impairment (eGFR <60 ml/min), Cerebrovascular disease(, ≥ 2 peripheral vascular beds affected, intermittent claudication, ABI <0.9, smoking, hypertension, hyperlipidaemia, carotid stenosis), and routinely collected key laboratory data."},{"outcome_type":"secondary","measure":"Number of participants with revascularization procedures and prior interventions (PCI, CABG), peripheral revascularization procedures","time_frame":"Up to 13 months"},{"outcome_type":"secondary","measure":"Type of prior and concomitant antithrombotic treatment and other secondary prevention therapies in patients with CAD or PAD","time_frame":"Up to 13 months"},{"outcome_type":"secondary","measure":"Dose of prior and concomitant antithrombotic treatment and other secondary prevention therapies in patients with CAD or PAD","time_frame":"Up to 13 months"},{"outcome_type":"secondary","measure":"Duration of prior and concomitant antithrombotic treatment and other secondary prevention therapies in patients with CAD or PAD","time_frame":"Up to 13 months"},{"outcome_type":"secondary","measure":"Reasons and decision points for introducing rivaroxaban 2.5 mg [BID]","time_frame":"Up to 13 months","description":"BID: twice per day dosing"},{"outcome_type":"secondary","measure":"Reasons for discontinuation of rivaroxaban 2.5 mg [BID].","time_frame":"Up to 13 months"},{"outcome_type":"secondary","measure":"Planned and actual duration of treatment with rivaroxaban 2.5 mg [BID].","time_frame":"Up to 13 months"},{"outcome_type":"secondary","measure":"Planned and actual duration of treatment with ASA 75 mg [OD]","time_frame":"Up to 13 months","description":"QD:once per day dosing"}]}
{"nct_id":"NCT05033548","start_date":"2021-10-10","enrollment":4000,"brief_title":"Technology Enabled And Molecular Monitoring of the Allograft and Transplant rEcipient","official_title":"Technology Enabled And Molecular Monitoring of the Allograft and Transplant rEcipient","primary_completion_date":"2024-10-10","study_type":"Observational [Patient Registry]","rec_status":"Not yet recruiting","completion_date":"2024-10-10","last_update":"2021-09-05","description":"The primary objective of the study is to assess the impact of AlloCare mHealth remote monitoring on the early post-transplant period in solid organ transplantation.The outcome measure for primary objective is overall reduction in Readmission Rate to hospital in 90 days for all causes. Patients will be assessed across 4 different organ groups (Kidney, Liver, Lung and Heart Transplantation). The secondary objective is to consider the impact of mHealth and app-based monitoring on variables known to impact long term outcomes over the first 12 months post transplantation, as well as impact on quality of life. The outcome measures for secondary objective are: 1. Tacrolimus Variability (Time in Therapeutic Range,) as a surrogate to adherence and compliance 2. BPAR within 3,6, and 12 months 3. Patient satisfaction at 90 days 4. SF-36 change at 90 days 5. HbA1c monitoring (diabetic patients only)","other_id":"SN-C-00018","observational_model":"Case-Control","time_perspective":"Cross-Sectional","sampling_method":"Probability Sample","gender":"All","minimum_age":12,"population":"Participants with a single solid organ transplant of either Lung, Liver, Kidney or Heart,\r\n        will be invited to participate.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Participant is willing and able to give informed consent for participation in the\r\n             study.\r\n\r\n          -  Male or Female, aged 12 years or above. (Gillick Competent)\r\n\r\n        Exclusion Criteria:\r\n\r\n        The participant may not enter the trial if ANY of the following apply:\r\n\r\n          -  Participant who is pregnant, lactating or planning pregnancy during the trial.\r\n\r\n          -  Significant hepatic impairment (determined by the PI)\r\n\r\n          -  Scheduled elective surgery or other procedures requiring general anaesthesia during\r\n             the trial.\r\n\r\n          -  Participant with life expectancy of less than 6 months, or inappropriate for\r\n             diagnostic monitoring through regular blood sampling.\r\n\r\n          -  >3 months post-transplant\r\n\r\n          -  Any other significant disease or disorder which, in the opinion of the Investigator,\r\n             may either put the participants at risk because of participation in the trial, or may\r\n             influence the result of the trial, or the participant's ability to participate in the\r\n             trial.\r\n\r\n          -  Participants who have participated in another research trial involving an\r\n             investigational pharmaceutical product in the past 12 weeks.\r\n\r\n          -  Multi-organ transplant (e.g., Kidney-Pancreas).\r\n\r\n          -  Recipients of a transplant from a monozygotic (identical) twin\r\n\r\n          -  Recipient of non-autologous bone marrow transplant\r\n\r\n          -  Patients with a history of needle phobia.\r\n\r\n          -  Patients who are not English or Spanish speaking\r\n      ","sponsor":"CareDx","sponsor_type":"Industry","conditions":"Transplant","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Overall reduction in Readmission Rate to hospital within 90 days (all causes)","time_frame":"90 days","description":"The aim of this study is to evaluate AlloCare and remote patient monitoring developed as an integrated mHealth service, assessing whether the combination of app and monitoring deployed within the solid organ transplant population can help support durable behavioral changes in patients that improve self-care and shared decision-making within the patient-provider relationship."},{"outcome_type":"secondary","measure":"Tacrolimus Variability (Time in Therapeutic Range,) at 3,6, and 12 months as a surrogate to adherence and compliance","time_frame":"3, 6, and 12 months","description":"Use of Allocare is hoped to empower patient self-care with improved monitoring with result in fewer readmissions after transplant and reduced clinic visits, better medication adherence, and fewer immunosuppression related complications when compared to standard of care."},{"outcome_type":"secondary","measure":"BPAR at 3, 6, and 12 months","time_frame":"3, 6, and 12 months","description":"Use of Allocare is hoped to empower patient self-care with improved monitoring with result in fewer readmissions after transplant and reduced clinic visits, better medication adherence, and fewer immunosuppression related complications when compared to standard of care."},{"outcome_type":"secondary","measure":"Patient satisfaction at 90 days","time_frame":"90 days","description":"Use of Allocare is hoped to empower patient self-care with improved monitoring with result in fewer readmissions after transplant and reduced clinic visits, better medication adherence, and fewer immunosuppression related complications when compared to standard of care. In addition, use of the app will lead to improved patient and provider satisfaction at 90 days."},{"outcome_type":"secondary","measure":"SF-36 change at 90 days","time_frame":"90 days","description":"Use of Allocare is hoped to empower patient self-care with improved monitoring with result in fewer readmissions after transplant and reduced clinic visits, better medication adherence, and fewer immunosuppression related complications when compared to standard of care."},{"outcome_type":"secondary","measure":"HbA1c monitoring (diabetic patients only) at 3,6, and 12 months","time_frame":"3, 6, and 12 months","description":"Use of Allocare is hoped to empower patient self-care with improved monitoring with result in fewer readmissions after transplant and reduced clinic visits, better medication adherence, and fewer immunosuppression related complications when compared to standard of care."}]}
{"nct_id":"NCT05038761","start_date":"2021-10-08","enrollment":150,"brief_title":"A Study to Learn How Well a Blood Sugar Monitoring System Called Cascade Which Measures Glucose on an Ongoing Basis Works and How Safe it is in Chinese Patients in Usual Practice","official_title":"A Prospective Observational Study to Evaluate the Effectiveness and Safety of Cascade Continuous Glucose Monitoring System in China: A Real World Study","primary_completion_date":"2022-01-07","study_type":"Observational","rec_status":"Not yet recruiting","completion_date":"2022-03-04","last_update":"2021-09-09","description":"Researchers are looking for a better way to help Chinese people who have diabetes to monitor their blood sugar situation. There are 2 types of diabetes. In people with type 1 diabetes, the body's immune system attacks and destroys cells in the pancreas that produce a hormone called insulin. In people with type 2 diabetes, the body does not make enough insulin or does not use insulin well. This results in high blood sugar (glucose) levels. Over time, high blood sugar levels can cause damage to certain parts of the body. These include the eyes, the kidneys, the nerves, and the heart. There are tests and devices available for doctors and patients to measure blood sugar levels. In order to see if the diabetes treatment is workable to stabilize the blood sugar level, repeated blood sugar measurement is always needed. Such tracking of the blood sugar is also called blood sugar monitoring. Blood sugar monitoring tests and devices can however be difficult to use and one test or device may not work for all patients. Researchers think that better monitoring systems would help patients improve the control of their blood sugar levels. This could help to stabilize their blood sugar condition. In this study, the researchers want to learn more about how well a new monitoring system called Cascade works in Chinese patients with diabetes. Cascade is a continuous glucose monitoring system. It regularly measures the level of glucose in the tissue throughout the day and night. Cascade is made up of a small sensor that patients apply in the belly region where it is placed just under the skin, into the so-called subcutaneous tissue. The sensor measures the level of glucose in the fluid that surrounds cells in the subcutaneous tissue. It also has a transmitter which attaches to the sensor and sends the results via Bluetooth to a smart device, which can instantly display the glucose level. The glucose level can then be used to adjust the treatment. The main purpose of this study is to learn how well Cascade monitors glucose levels in Chinese patients when used in usual practice. To answer this question, the researchers will compare the glucose levels collected with the Cascade monitor to the blood sugar levels collected with venous blood glucose testing. This is where a blood sample is taken from the veins, and then the level of sugar in the blood sample is measured. The study will include adult Chinese patients who have type 1 or type 2 diabetes and who the study doctors think need to monitor their diabetes using Cascade and venous blood glucose testing. There will be no study treatments given as part of this study. The patients will be in the study for up to 18 days. The device will be worn up to a maximum of 14 days. The total duration of the study will be about 4 months. The patients will get training on how to use the Cascade monitor and will attach it to their belly area on Day 1 of the study. The patients will wear Cascade for up to 14 days. The researchers will then collect the information about their glucose levels. The study doctors will also take blood samples and measure blood sugar levels using venous blood glucose testing. They will compare the sugar levels recorded from the blood samples to the glucose levels recorded by Cascade at the closest time points. After wearing Cascade for 14 days, the study doctors will remove it from the patients' bellies. About 3 days later, the researchers will call the patients to check for any discomfort that has happened after the removal of the Cascade device. The patients may also take photos of the area and send these to the study doctors. During the study, the study staff will: - take blood samples as part of the usual care - compare glucose levels recorded by Cascade to the levels recorded from the venous blood glucose tests - check the skin for any swelling or areas of rash where Cascade was worn  record any instances of Cascade errors or malfunctioning - record any alarms for when glucose levels are too high or too low - check the patients' overall health - ask the patients about how they are feeling and what medical problems they are having.","other_id":"21972","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Female and/or male patients with a diagnosis of type 1 or type 2 diabetes mellitus will be\r\n        enrolled after the decision to initiate venous blood glucose testing and Cascade CGM as per\r\n        investigator's routine treatment practice.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adult female or male (18 years of age or older)\r\n\r\n          -  Diagnosed with type 1 or type 2 diabetes mellitus\r\n\r\n          -  Decision to initiate venous blood glucose testing and Cascade CGM as per\r\n             investigator's routine treatment practice;\r\n\r\n          -  Signed informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with moderate or more serious anemia defined as hemoglobin < 90g/L\r\n\r\n          -  Patients with moderate or more serious subcutaneous edema: grading can be referred to:\r\n             mild edema (a visible mild depression of eyelid, soft tissues below the orbit,\r\n             subcutaneous tissue of the anterior tibia or subcutaneous tissue of the ankle after\r\n             finger pressure); moderate (all the sparse tissues of the whole body have visible\r\n             edema with obvious or deeper tissue depressions after finger pressure and slow\r\n             subsidence); severe (severe edema of tissues all over the body, the skin of the low\r\n             hanging part of the body is tense and shiny, and there may even be fluid exudation,\r\n             sometimes accompanied by fluid accumulation in the thoracic cavity, abdominal cavity\r\n             and sphincter cavity)\r\n\r\n          -  Pregnant women\r\n      ","sponsor":"Bayer","sponsor_type":"Industry","conditions":"Continuous Glucose Monitoring|Diabetes Mellitus","interventions":[{"intervention_type":"Device","name":"Device: Cascade CGM System","description":"Following the manner of observational study, no intervention will be used for the study.\r\nParticipants will wear one Cascade CGM on abdomen or lower area for no longer than 14 days."},{"intervention_type":"Device","name":"Device: Blood Glucose Meter (BGM)","description":"Calibration device"}],"outcomes":[{"outcome_type":"secondary","measure":"15/15% agreement rate with reference value","time_frame":"From the device-wearing to device-removal, up to 14 days","description":"To compare Cascade CGM values with reference venous blood glucose values and to analyze the agreement rate"},{"outcome_type":"primary","measure":"20/20% agreement rate with reference value","time_frame":"From the device-wearing to device-removal, up to 14 days","description":"To compare Cascade CGM values with reference venous blood glucose values and to analyze the agreement rate"},{"outcome_type":"secondary","measure":"30/30% agreement rate with reference value","time_frame":"From the device-wearing to device-removal, up to 14 days","description":"To compare Cascade CGM values with reference venous blood glucose values and to analyze the agreement rate"},{"outcome_type":"secondary","measure":"Scores of questionnaire on Ease of Use","time_frame":"Day 14","description":"A questionnaire on Ease of Use will be used to evaluate the Ease of Use of the study device through user ratings of the study device.\r\n5-point-scale with 1=Very Unsatisfied, 5=Very Satisfied."},{"outcome_type":"secondary","measure":"Sensor lifespan: proportion of sensor failures","time_frame":"From the device-wearing to device-removal, up to 14 days"},{"outcome_type":"secondary","measure":"The frequency and cause of study device alarm/alert","time_frame":"From the device-wearing to device-removal, up to 14 days"},{"outcome_type":"secondary","measure":"Number and proportion of cases of device failure/defect event","time_frame":"From the device-wearing to device-removal, up to 14 days"},{"outcome_type":"secondary","measure":"Pain score","time_frame":"Day 1","description":"The Gracely Box Scale will be used to evaluate the pain level of first Cascade CGM sensor insertion, and the pain level of first BGM fingertip blood glucose collection.\r\nGracely Box Scale is a visual analog of 0 (0=No pain sensation) to 20, used by a participant to define the pain intensity experience."},{"outcome_type":"secondary","measure":"Number of participants with adverse events/serious adverse events","time_frame":"From day 1 to follow up (day 17 +- 1)"},{"outcome_type":"secondary","measure":"AE with special concern: erythema/edema under the adhesive patch or at the insertion site","time_frame":"From the device-wearing to device-removal, up to 14 days","description":"A Draize score (0 to 3) will be used to assess the degree of erythema and edema, with higher scores representing a higher severity of symptoms."}]}
{"nct_id":"NCT05029856","start_date":"2021-10-04","phase":"Phase 1/Phase 2","enrollment":240,"brief_title":"Evaluation of the Safety and Immunogenicity of SII Vaccine Constructs Based on the SARS-CoV-2 (COVID-19) Variant in Adults","official_title":"A Randomized, Observer-Blinded, Phase 1/2 Study With an Open-Label Group to Evaluate the Safety and Immunogenicity of SII Vaccine Constructs Based on SARS-CoV-2 Variants in Adults","primary_completion_date":"2021-11-10","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2022-06-30","last_update":"2021-09-16","description":"This is a randomized, observer-blinded, Phase 1/2 study with an open-label group to evaluate the safety and immunogenicity of 3 novel SARS-CoV-2 variant vaccine constructs adjuvanted with Matrix-M1 adjuvant. Investigational products will include a monovalent SII SARS-CoV-2 B.1.351 (Beta) variant vaccine (SII B.1.351), a bivalent SII vaccine containing antigen for both the ancestral strain and B.1.351 (Beta) variant of SARS-CoV-2 (SII Bivalent), and a monovalent SII SARS-CoV-2 B.1.617.2 (Delta) variant vaccine (SII B.1.617.2).","other_id":"2019nCoV-102","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":64,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Adults 18 to 64 years of age, inclusive, at screening.\r\n\r\n          2. Willing and able to give informed consent prior to study enrollment and to comply with\r\n             study procedures.\r\n\r\n          3. Female participants of childbearing potential (defined as any participant who has\r\n             experienced menarche and who is NOT surgically sterile [ie, hysterectomy, bilateral\r\n             tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at\r\n             least 12 consecutive months]) must agree to be heterosexually inactive from at least\r\n             28 days prior to enrollment and through the end of the study OR agree to consistently\r\n             use a medically acceptable method of contraception listed below from at least 28 days\r\n             prior to enrollment and through the end of the study.\r\n\r\n               1. Condoms (male or female) with spermicide (if acceptable in country)\r\n\r\n               2. Diaphragm with spermicide\r\n\r\n               3. Cervical cap with spermicide\r\n\r\n               4. Intrauterine device\r\n\r\n               5. Oral or patch contraceptives\r\n\r\n               6. Norplant, Depo-Provera, or other in-country regulatory approved contraceptive\r\n                  method that is designed to protect against pregnancy\r\n\r\n               7. Abstinence, as a form of contraception, is acceptable if in line with the\r\n                  participant's lifestyle\r\n\r\n          4. Is medically stable, as determined by the investigator (based on a review of health\r\n             status, vital signs [to include body temperature], medical history, and targeted\r\n             physical examination [to include body weight]). Vital signs must be within medically\r\n             acceptable ranges prior to the first vaccination.\r\n\r\n          5. Agrees to not participate in any other SARS-CoV-2 prevention or treatment trials for\r\n             the duration of the study.\r\n\r\n             For previously vaccinated Participants (Groups C, D and H):\r\n\r\n          6. Documented receipt of 2 doses of the investigational Novavax vaccine with Matrix-M1\r\n             adjuvant (NVX-CoV2373) administered approximately 21 days apart or 2 doses of a\r\n             TGA-authorized/approved COVID-19 vaccine administered at least 60 days prior to first\r\n             study vaccination.\r\n\r\n        Exclusion Criteria:\r\n\r\n        If an individual meets any of the following criteria, he or she is ineligible for this\r\n        study:\r\n\r\n          1. History of laboratory-confirmed (by PCR or serology to SARS-CoV-2) COVID-19 infection\r\n             at any time prior to randomization/enrollment.\r\n\r\n          2. Previous receipt of any investigational or authorized/approved vaccine, prophylactic\r\n             or therapeutic agent for the prevention or treatment of SARS-CoV-2 infection, except\r\n             for previously vaccinated participants.\r\n\r\n          3. Participation in research involving receipt of investigational products\r\n             (drug/biologic/device) within 90 days prior to first study vaccination.\r\n\r\n          4. Received influenza vaccination within 14 days prior to first study vaccination, or any\r\n             other vaccine within 30 days prior to the first study vaccination.\r\n\r\n          5. Any known allergies to products contained in the investigational product.\r\n\r\n          6. Any history of anaphylaxis to any prior vaccine.\r\n\r\n          7. Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) requiring\r\n             ongoing immunomodulatory therapy.\r\n\r\n          8. Chronic administration (defined as > 14 continuous days) of immunosuppressants,\r\n             systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to\r\n             first study vaccination.\r\n\r\n          9. Received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90\r\n             days prior to first study vaccination.\r\n\r\n         10. Active cancer (malignancy) on therapy within 3 years prior to first study vaccination\r\n             (with the exception of adequately treated non-melanomatous skin carcinoma or lentigo\r\n             maligna and uterine cervical carcinoma in situ without evidence of disease, at the\r\n             discretion of the investigator).\r\n\r\n         11. Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to\r\n             the end of study.\r\n\r\n         12. Suspected or known history of alcohol abuse or drug addiction within 2 years prior to\r\n             the first study vaccine dose that, in the opinion of the investigator, might interfere\r\n             with protocol compliance.\r\n\r\n         13. Any other condition that, in the opinion of the investigator, would pose a health risk\r\n             to the participant if enrolled or could interfere with evaluation of the study vaccine\r\n             or interpretation of study results (including neurologic or psychiatric conditions\r\n             likely to impair the quality of safety reporting).\r\n\r\n         14. Study team member or immediate family member of any study team member (inclusive of\r\n             Sponsor, CRO, and study site personnel involved in the conduct or planning of the\r\n             study).\r\n      ","sponsor":"Novavax","sponsor_type":"Industry","conditions":"Covid19","interventions":[{"intervention_type":"Biological","name":"Biological: SII B.1.351","description":"Intramuscular (deltoid) injections of 3 g SII B.1.351 and 50 g Matrix-M1 Adjuvant,\r\n1 or 2 doses:1 on Day 0 and  1 on Day 21."},{"intervention_type":"Biological","name":"Biological: SII B.1.351","description":"Intramuscular (deltoid) injections of 5 g SII B.1.351 and 50 g Matrix-M1 Adjuvant,\r\n1 or 2 doses:1 on Day 0 and  1 on Day 21."},{"intervention_type":"Biological","name":"Biological: SII Bivalent","description":"Intramuscular (deltoid) injections of 6 g SII Bivalent and 50 g Matrix-M1 Adjuvant, 2 doses: 1 on Day 0 and 1 on Day 21."},{"intervention_type":"Biological","name":"Biological: SII Bivalent","description":"Intramuscular (deltoid) injections of 10 g SII Bivalent and 50 g Matrix-M1 Adjuvant, 2 doses: 1 on Day 0 and 1 on Day 21."},{"intervention_type":"Biological","name":"Biological: SII B.1.617.2","description":"Intramuscular (deltoid) injections of 5 g SII B.1.617.2 and 50 g Matrix-M1 Adjuvant,\r\n1 or 2 doses:1 on Day 0 and  1 on Day 21."}],"outcomes":[{"outcome_type":"primary","measure":"MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) expressed as GMT","time_frame":"Day 14 and Day 35","description":"(MN50) geometric mean titers (GMTs) to the SARS-CoV-2 B.1.351 (Beta) variant at Day 14 (one-dose regimen; Groups C and D) and Day 35 (two-dose regimen; Groups A and B);"},{"outcome_type":"primary","measure":"MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) expressed as SCRs/SRRs","time_frame":"Day 14 and Day 35","description":"Seroconversion rates (SCRs) or seroresponse rates (SRRs) (proportion of participants who achieve ≥ 4-fold increase from baseline) in MN50 titer concentrations to the SARS-CoV-2 B.1.351 (Beta) variant following their last vaccination."},{"outcome_type":"primary","measure":"MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta)expressed as GMT","time_frame":"Day 14 and Day 35","description":"Neutralizing antibody MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta) variant at Day 14 (one-dose regimen; Group H) and Day 35 (two-dose regimen; Group G);"},{"outcome_type":"primary","measure":"MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta)expressed as SCRs/SRRs","time_frame":"Day 14 and Day 35","description":"SCRs/SRRs (proportion of participants who achieve ≥ 4-fold increase from baseline) in MN50 titer concentrations to the SARS-CoV-2 Delta variant following their last vaccination."},{"outcome_type":"primary","measure":"Incidence, duration, and severity of solicited local and systemic adverse events (AEs)","time_frame":"Day 0 to Day 7","description":"Incidence, duration, and severity of solicited local and systemic adverse events (AEs) for 7 days following each vaccination"},{"outcome_type":"primary","measure":"Incidence, duration, severity, and relationship of unsolicited AEs through 28 days","time_frame":"Day 0 to Day 28","description":"Incidence, duration, severity, and relationship of unsolicited AEs through 28 days after the last vaccination"},{"outcome_type":"primary","measure":"Incidence and relationship of medically attended adverse events (MAAEs), adverse events of special interest (AESIs) (predefined list), and serious adverse events (SAEs)","time_frame":"Day 0 to Day 217","description":"Incidence and relationship of medically attended adverse events (MAAEs), adverse events of special interest (AESIs) (predefined list), and serious adverse events (SAEs) throughout the study."},{"outcome_type":"secondary","measure":"MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) expressed as GMFR in previously vaccinated patients","time_frame":"Day 0 to Day 189","description":"MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) variants and to the ancestral SARS-CoV-2 strain at Days 0, 14, and 189 in previously vaccinated individuals"},{"outcome_type":"secondary","measure":"MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) expressed as GMFR in participants seronegative at baseline","time_frame":"Day 0 to Day 217","description":"MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) variants and to the ancestral SARS-CoV-2 strain at Days 0, 21, 35, and 217 in participants seronegative at baseline."},{"outcome_type":"secondary","measure":"MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) expressed as SCRs/SRRs in previously vaccinated patients","time_frame":"Day 0 to Day 189","description":"MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) variants and to the ancestral SARS-CoV-2 strain at Days 0, 14, and 189 in previously vaccinated individuals"},{"outcome_type":"secondary","measure":"MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) expressed as SCRs/SRRs in participants seronegative at baseline.","time_frame":"Day 0 to Day 217","description":"MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) variants and to the ancestral SARS-CoV-2 strain at Days 0, 21, 35, and 217 in participants seronegative at baseline."},{"outcome_type":"secondary","measure":"MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta) expressed as GMFR in participants seronegative at baseline","time_frame":"Day 0 to Day 217","description":"MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta) variants and to the ancestral SARS-CoV-2 strain at Days 0, 21, 35, and 217 in participants seronegative at baseline."},{"outcome_type":"secondary","measure":"MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta) expressed as GMFR in previously vaccinated participants","time_frame":"Day 0 to Day 189","description":"MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta) variants and to the ancestral SARS-CoV-2 strain at Days 0, 14, and 189 in previously vaccinated individuals"},{"outcome_type":"secondary","measure":"MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta)expressed as SCRs/ SRRs in participants seronegative at baseline","time_frame":"Day 0 to Day 217","description":"MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta) variants and to the ancestral SARS-CoV-2 strain at Days 0, 21, 35, and 217 in participants seronegative at baseline."},{"outcome_type":"secondary","measure":"MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta)expressed as SCRs/ SRRs in previously vaccinated participants","time_frame":"Day 0 to Day 189","description":"MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta) variants and to the ancestral SARS-CoV-2 strain at Days 0, 14, and 189 in previously vaccinated individuals"},{"outcome_type":"secondary","measure":"IgG geometric mean concentrations (GMCs) to the SARS-CoV-2 B.1.351 (Beta) expressed as GMFR in previously vaccinated participants","time_frame":"Day 0 to Day 189","description":"IgG geometric mean concentrations (GMCs) to the SARS-CoV-2 B.1.351 (Beta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein at Days 0, 14, and 189 in previously vaccinated individuals"},{"outcome_type":"secondary","measure":"IgG geometric mean concentrations (GMCs) to the SARS-CoV-2 B.1.351 (Beta) expressed as GMFR in participants seronegative at baseline","time_frame":"Day 0 to Day 217","description":"IgG geometric mean concentrations (GMCs) to the SARS-CoV-2 B.1.351 (Beta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein at Days 0, 21, 35, and 217 in participants seronegative at baseline."},{"outcome_type":"secondary","measure":"IgG geometric mean concentrations (GMCs) to the B.1.617.2 (Delta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein in participants seronegative at baseline","time_frame":"Day 0 to Day 217","description":"IgG geometric mean concentrations (GMCs) to the SARS-CoV-2 B.1.617.2 (Delta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein at Days 0, 21, 35, and 217 in participants seronegative at baseline."},{"outcome_type":"secondary","measure":"IgG geometric mean concentrations (GMCs) to the B.1.617.2 (Delta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein in previously vaccinated participants","time_frame":"Day 0 to Day 189","description":"IgG geometric mean concentrations (GMCs) to the SARS-CoV-2 B.1.617.2 (Delta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein at Days 0, 14, and 189 in previously vaccinated individuals"},{"outcome_type":"secondary","measure":"Human Angiotensin-Converting Enzyme 2 (hACE2) receptor binding inhibition assay GMT to the SARS-CoV-2 B.1.351 (Beta) expressed as GMFR in previously vaccinated participants","time_frame":"Day 0 to Day 189","description":"GMTs to the SARS-CoV-2 B.1.351 (Beta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein at Days 0, 14, and 189 in previously vaccinated individuals"},{"outcome_type":"secondary","measure":"Human Angiotensin-Converting Enzyme 2 (hACE2) receptor binding inhibition assay GMT to the SARS-CoV-2 B.1.351 (Beta) expressed as GMFR in participants seronegative at baseline","time_frame":"Day 0 to Day 217","description":"GMTs to the SARS-CoV-2 B.1.351 (Beta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein at Days 0, 21, 35, and 217 in participants seronegative at baseline."},{"outcome_type":"secondary","measure":"Human Angiotensin-Converting Enzyme 2 (hACE2) receptor binding inhibition assay GMT to the SARS-CoV-2 B.1.351 (Beta) expressed as SCRs/SRRs in previously vaccinated participants","time_frame":"Day 0 to Day 189","description":"GMTs to the SARS-CoV-2 B.1.351 (Beta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein at Days 0, 14, and 189 in previously vaccinated individuals"},{"outcome_type":"secondary","measure":"Human Angiotensin-Converting Enzyme 2 (hACE2) receptor binding inhibition assay GMT to the SARS-CoV-2 B.1.351 (Beta) expressed as SCRs/SRRs in participants seronegative at baseline","time_frame":"Day 0 to Day 217","description":"GMTs to the SARS-CoV-2 B.1.351 (Beta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein at Days 0, 14, and 189 at Days 0, 21, 35, and 217 in participants seronegative at baseline."},{"outcome_type":"secondary","measure":"Human Angiotensin-Converting Enzyme 2 (hACE2) receptor binding inhibition assay GMT to the SARS-CoV-2 B.1.617.2 (Delta) expressed as GMFR in participants seronegative at baseline","time_frame":"Day 0 to Day 217","description":"GMTs to the SARS-CoV-2 B.1.617.2 (Delta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein and at Days 0, 21, 35, and 217 in participants seronegative at baseline."},{"outcome_type":"secondary","measure":"Human Angiotensin-Converting Enzyme 2 (hACE2) receptor binding inhibition assay GMT to the SARS-CoV-2 B.1.617.2 (Delta) expressed as GMFR in previously vaccinated participants","time_frame":"Day 0 to Day 189","description":"GMTs to the SARS-CoV-2 B.1.617.2 (Delta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein and at Days 0, 14, and 189 in previously vaccinated individuals"},{"outcome_type":"secondary","measure":"Human Angiotensin-Converting Enzyme 2 (hACE2) receptor binding inhibition assay GMT to the SARS-CoV-2 B.1.617.2 (Delta) expressed as SCRs/SRRs in participants seronegative at baseline","time_frame":"Day 0 to Day 217","description":"GMTs to the SARS-CoV-2 B.1.617.2 (Delta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein and at Days 0, 21, 35, and 217 in participants seronegative at baseline."},{"outcome_type":"secondary","measure":"Human Angiotensin-Converting Enzyme 2 (hACE2) receptor binding inhibition assay GMT to the SARS-CoV-2 B.1.617.2 (Delta) expressed as SCRs/SRRs in previously vaccinated participants","time_frame":"Day 0 to Day 189","description":"GMTs to the SARS-CoV-2 B.1.617.2 (Delta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein and at Days 0, 14, and 189 in previously vaccinated individuals"}]}
{"nct_id":"NCT05044754","start_date":"2021-10-01","enrollment":50,"brief_title":"SCAP vs HIFU for Recurrent Prostate Cancer After Radiation Therapy","official_title":"Salvage Cryoablation of the Prostate (SCAP) vs High Intensity Focal Ultrasounds (HIFU) for Recurrent Prostate Cancer After Radiation Therapy","primary_completion_date":"2023-10-01","study_type":"Observational [Patient Registry]","rec_status":"Recruiting","completion_date":"2024-10-01","last_update":"2021-09-16","description":"The evidence base relating to the use of SCAP and HIFU is poor, with significant uncertainties relating to long-term oncological outcomes. One of the main limitations when the few studies reported are analyzed is the lack of information about the histopathology both before starting treatment and at the time of recurrence after cryotherapy. The vast majority of studies refer only to BCR-free survival as end point, thus limiting interpretation of real oncological performance of this technique. Furthermore, side effects vary widely from study to study and there are uncertainties about the real morbidity associated to cryotherapy in the salvage setting. Another important hot issue in this scenario is the potential benefit that new imaging and diagnosis techniques (MRI, targeted biopsy, PSMA) may add for a more accurate indication. This could provide the possibility of better results for SCAP. The clinical value of this new diagnostic tools is unknown in this scenario and needs to be explored.","other_id":"SALVPROST-YAU-21","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"Male","minimum_age":18,"maximum_age":90,"population":"Patients suffering local recurrence of prostate cancer after primary treatment with\r\n        radiation therapy","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with local recurrence (with histological confirmation) after treatment with\r\n             radiotherapy or brachytherapy without evidence of distant involvement evaluated\r\n             preferably with PET/PSMA (if not available then Fluciclovine PET/CT or choline PET/CT\r\n             must be performed).\r\n\r\n          -  Life expectancy >10 years\r\n\r\n          -  Prostate volume < 100cc\r\n\r\n          -  PSA<10 ng/mL\r\n\r\n          -  mpMRI + fusion/systematic biopsy (template suppl 1) o mpMRI cT3a without affecting\r\n             the bladder neck or the membranous urethra so that the continence mechanisms of the\r\n             sphincter are not compromised.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with clinically confirmed distant metastasis\r\n\r\n          -  Any previous major rectal surgery\r\n\r\n          -  Clinically significant lower urinary tract or rectal anomalies\r\n\r\n          -  Existing urethral, rectal, or bladder fistulae\r\n      ","sponsor":"University Hospital Virgen de las Nieves","sponsor_type":"Other","conditions":"Cryotherapy|High Intensity Focused Ultrasounds|Recurrent Prostate Cancer","interventions":[{"intervention_type":"Procedure","name":"Procedure: Local treatment of the prostate (SCAP or HIFU)","description":"Once the local involvement of the recurrent prostate cancer is confirmed, patient will undergo local treatment of the prostate (SCAP or HIFU)"}],"outcomes":[{"outcome_type":"secondary","measure":"Sexual function","time_frame":"1 year","description":"Changes in sexual function (IIEF questionanaire)"},{"outcome_type":"secondary","measure":"Low urinary tract function","time_frame":"1 year","description":"Changes in IPSS questionnaire"},{"outcome_type":"primary","measure":"DFS-histology","time_frame":"1 year","description":"Disease free survival (confirmed by follow-up biopsy)"},{"outcome_type":"primary","measure":"DFS-image","time_frame":"1 year","description":"Disease free survival (confirmed by follow-up PET-CT )"},{"outcome_type":"primary","measure":"ADT-FS","time_frame":"5 years","description":"Androgen deprivation therapy free survival."},{"outcome_type":"secondary","measure":"BCR free survival","time_frame":"5 years","description":"Time free of biochemical recurrence (PSA)"},{"outcome_type":"secondary","measure":"MFS-PET","time_frame":"5 years f-u","description":"Metastasis free survival. rate of patients without any metastasis detected on PET-CT."},{"outcome_type":"secondary","measure":"Complications rate","time_frame":"1 year","description":"Rate of early and long-term complications"},{"outcome_type":"secondary","measure":"Continence","time_frame":"1 year","description":"Change in continence scores (ICIQ-SF q)"}]}
{"nct_id":"NCT04325802","start_date":"2021-10-01","phase":"Phase 2","enrollment":56,"brief_title":"Treatment of Chronic Itch in Atopic Dermatitis With Opioid Antagonist Naltrexone","official_title":"Treatment of Chronic Itch in Atopic Dermatitis With Opioid Antagonist Naltrexone and Effects on Skin Circadian Rhythm","primary_completion_date":"2024-06-30","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2024-06-30","last_update":"2021-04-19","description":"Purpose: To study the etiology and the epigenetic pathways leading to and regulating chronic itch. Similarly, to examine the mechanisms underlying skin changes, including epigenetic alterations while also testing the efficacy of opioid antagonists in atopic dermatitis. In this study, the investigators aim to examine chronic sensory disorder mechanisms related to chronic itch.","other_id":"DERM-2019-28471","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosis of AD via simplified UK Working Group Criteria and a baseline PSGA score of\r\n             2 or greater\r\n\r\n          -  Willingness to adhere to study protocol\r\n\r\n          -  Subjects taking hormone-containing medications must be on a stable dose for 6 months\r\n             prior to study start to avoid any confounding influence on sensory and pain perception\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Use of topical or oral anti-inflammatory medications for 2 weeks prior to the study\r\n             start.\r\n\r\n          -  Use of topical or oral anti-histamines for 2 weeks prior to the study start (as rescue\r\n             medication allowed).\r\n\r\n          -  Use of topical or oral anti-pruritic agents for 2 weeks prior to the study start.\r\n\r\n          -  Use of oral neuromodulatory agents for 2 months prior to study start.\r\n\r\n          -  Current use of chronic pain medications (including opioids, antidepressants and\r\n             anti-epileptic drugs).\r\n\r\n          -  Use of nicotine-containing products for the past 6 months prior to study start.\r\n\r\n          -  History of radiation or chemotherapy.\r\n\r\n          -  History of traumatic injury on prospective test sites.\r\n\r\n          -  Unstable thyroid function within the past 6 months prior to study start to exclude\r\n             thyroid-related neuropathy\r\n\r\n          -  Known history of central or peripheral nervous system dysfunction.\r\n\r\n          -  History of acute hepatitis, chronic liver disease or end stage liver disease.\r\n\r\n          -  History of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome.\r\n\r\n          -  History of neuropathy associated with chronic obstructive pulmonary disease, diabetes\r\n             mellitus, documented exposure to organophosphates or heavy metals or polychlorinated\r\n             biphenyls.\r\n\r\n          -  Known nutritional deficiency (vitamin B12, vitamin D, iron or zinc) within 3 months\r\n             prior to the study start.\r\n\r\n          -  Use of illicit drugs within the past 6 months prior to study start and/or opioid use\r\n             disorder.\r\n\r\n          -  Regular use of opioids for chronic pain\r\n\r\n          -  Lyme disease, porphyria, rheumatoid arthritis, Hansen's disease (leprosy) or use of\r\n             antineoplastic chemotherapeutic agents.\r\n\r\n          -  Subject has any medical condition that, in the judgment of the Investigator, would\r\n             jeopardize the subject's safety following exposure to the administered medications.\r\n\r\n          -  Adults lacking capacity to consent\r\n      ","sponsor":"University of Minnesota","sponsor_type":"Other","conditions":"Atopic Dermatitis|Pruritus|Pruritus Chronic|Dermatitis","interventions":[{"intervention_type":"Drug","name":"Drug: Naltrexone","description":"50mg Naltrexone daily"},{"intervention_type":"Other","name":"Other: Placebo","description":"Placebo (Mannitol) daily"}],"outcomes":[{"outcome_type":"primary","measure":"Change in Itch Intensity (Visual Analog Scale)","time_frame":"1 week","description":"Change in itch intensity will be measured using a Visual Analogue scale (VAS). Scores range from 0 to 10, with higher scores indicating greater itch intensity."}]}
{"nct_id":"NCT04982614","start_date":"2021-10-01","phase":"Phase 4","enrollment":1400,"brief_title":"HPV Vaccination in HIV Infected and HIV Uninfected Adolescents in Eswatini","official_title":"A Multi-site, Open-label Non-inferiority Trial to Assess Immunogenicity of Two Doses of the Nonavalent Human Papillomavirus (HPV) Vaccine Among Children, Adolescents and Young Adults (9-26 Years) Living With HIV vs Three Doses of Nonavalent HPV Vaccine Among HIV Uninfected Young Women (15-26 Years) in Eswatini","primary_completion_date":"2023-03-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2023-03-31","last_update":"2021-07-29","description":"This is a multi-site, open-label non-inferiority study of the 9vHPV vaccine among a population of children, adolescents and young women living with HIV in Eswatini. This protocol seeks to assess immunogenicity of a two-dose 9vHPV vaccine regimen among girls and boys (9-14 years) and young women (15-26 years) living with HIV on antiretroviral therapy versus a three-dose 9vHPV vaccine regimen among HIV uninfected young women (15-26 years) in Eswatini. The secondary objectives include examining the safety profiles of the two-dose 9vHPV regimen in those living with HIV and the three-dose 9vHPV regimen in HIV-uninfected young women, as well as measuring the completion of the vaccination series among those living with HIV and those who are not infected with HIV.","other_id":"AAAT6912","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":9,"maximum_age":26,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        For people living with HIV receiving two-dose regimen:\r\n\r\n          -  Females 9-26 years and males 9-14 years,\r\n\r\n          -  Documented HIV infection,\r\n\r\n          -  Aware of HIV+ status,\r\n\r\n          -  Currently receiving antiretroviral treatment (ART) for HIV infection for at least six\r\n             months,\r\n\r\n          -  Living in Eswatini,\r\n\r\n          -  For individuals 18+ years: able to provide informed consent,\r\n\r\n          -  For individuals 15-17 years: able to provide informed assent,\r\n\r\n          -  For individuals 9-14 years of age: able to provide informed assent AND accompanied by\r\n             an adult caregiver who is able to give informed consent,\r\n\r\n          -  Intending to remain in the vicinity of the study sites for the study period\r\n\r\n        For reference group of HIV-uninfected women receiving three-dose regimen:\r\n\r\n          -  Females 15-26 years,\r\n\r\n          -  Documented negative HIV test at baseline\r\n\r\n          -  Living in Eswatini,\r\n\r\n          -  Able to provide informed assent (15-17 years) or informed consent (18-26 years)\r\n\r\n          -  Intending to remain in the vicinity of the study sites for the study period\r\n\r\n        Exclusion Criteria:\r\n\r\n        For ALL participants:\r\n\r\n          -  Diagnosis of other immunosuppressive diseases or receipt of immunosuppressive\r\n             medications,\r\n\r\n          -  Diagnosis of other acute or chronic illness,\r\n\r\n          -  Receipt of other vaccinations within 2-3 weeks before or after study vaccination,\r\n\r\n          -  Receipt of blood-derived products within 6 months before or during the study,\r\n\r\n          -  Previous receipt of an HPV vaccine,\r\n\r\n          -  Currently pregnant,\r\n\r\n          -  Known allergies to a vaccine component\r\n      ","sponsor":"Columbia University","sponsor_type":"Other","conditions":"HPV Infection|Hiv|HPV Vaccine","interventions":[{"intervention_type":"Biological","name":"Biological: Gardasil  9","description":"GARDASIL 9 is a vaccine indicated in girls and women 9 through 45 years of age for the prevention of the following diseases: Cervical, vulvar, vaginal, and anal cancer, and Genital warts (condyloma acuminata) caused by Human Papillomavirus (HPV).\r\n0.5-mL suspension for intramuscular injection as a single-dose vial and prefilled syringe at the following regimen/schedule: 9 through 14 years - 2-dose at 0, 6 to 12 months OR 3-dose at 0, 2, 6 months 15 through 45 years - 3-dose at 0, 2, 6 months"}],"outcomes":[{"outcome_type":"primary","measure":"Anti-HPV geometric mean antibody titers","time_frame":"Month 7 (4 weeks post Month 6 vaccine dose)","description":"Serum antibodies against HPV antigens (IgG, IFNg, TNF, IL2, CXCL10, granzyme, perforin, PTX3) based on cLIA testing. Geometric mean titers will be summarized by treatment group, and the ratios of mean GMTs between treatment and control and their 95% confidence intervals calculated around point estimates."},{"outcome_type":"primary","measure":"Number of seroconversions","time_frame":"Month 7 (4 weeks post Month 6 vaccine dose)","description":"Number of participants who seroconvert, defined as having no HPV antibodies pre-vaccination, but detectable HPV antibodies at 4 weeks post month 6 vaccine dose"},{"outcome_type":"secondary","measure":"Number of participants with serious adverse events (SAE)","time_frame":"Up to 6 months","description":"Number of participants who reported experiences of SAE. SAE is defined as those that experienced death, life-threatening conditions or hospitalizations."},{"outcome_type":"secondary","measure":"Number of participants completing vaccination series","time_frame":"Up to 6 months","description":"Number of eligible participants completing the 2-dose or 3-dose regimens will be tallied."}]}
{"nct_id":"NCT04597437","start_date":"2021-10-01","phase":"Early Phase 1","enrollment":74,"brief_title":"Zanamivir Treatment of Vascular Permeability in Dengue (ZAP-DENGUE)","official_title":"Zanamivir Treatment of Vascular Permeability in Dengue (ZAP-DENGUE): A Pilot Randomized Controlled Trial","primary_completion_date":"2022-09-30","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2022-09-30","last_update":"2020-10-22","description":"ZAP-DENGUE is a pilot randomized, double-blind, placebo-controlled evaluation of the safety and efficacy of five days of intravenous zanamivir treatment to treat vascular permeability syndrome which is the main cause of death in dengue fever.","other_id":"NCR203024","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","intervention_model_description":"Pilot, randomized, double-blind, placebo-controlled trial of the safety and efficacy of inhaled zanamivir (n=37) versus placebo (n=37) therapy for dengue","sampling_method":"","gender":"All","minimum_age":7,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Provision of signed and dated informed consent form.\r\n\r\n          2. Stated willingness to comply with all study procedures and availability for the\r\n             duration of the study.\r\n\r\n          3. Male or female, aged >7 years\r\n\r\n          4. Willingness to receive intravenous medication and be willing to adhere to the\r\n             medication regimen\r\n\r\n          5. Have a diagnosis of dengue by dengue NS1 rapid test\r\n\r\n          6. Have had a documented fever >38C in the last 24 hours.\r\n\r\n          7. Have dengue with warning signs as per the 2009 WHO criteria including one of the\r\n             following: abdominal pain or tenderness, persistent vomiting, clinical fluid\r\n             accumulation, mucosal bleeding, lethargy, restlessness, liver enlargement over 2 cm,\r\n             augmented hematocrit, thrombocytopenia or severe dengue defined as dengue with severe\r\n             plasma leakage leading to dengue shock and/or fluid accumulation with respiratory\r\n             distress; severe hemorrhage; severe organ impairment (hepatic damage, renal\r\n             impairment, cardiomyopathy, encephalopathy or encephalitis).\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Pregnancy or lactation\r\n\r\n          2. Children in Care of the state\r\n\r\n          3. Patients who are unlikely to survive 48 hours\r\n\r\n          4. Elevated alanine aminotransferase 3 times the upper limit of normal (ULN)\r\n\r\n          5. Total bilirubin 2  ULN\r\n\r\n          6. Unstable cardiac disease or arrhythmia at baseline\r\n\r\n          7. History of significant cardiac disease\r\n\r\n          8. Treatment with another investigational drug or other intervention within 1 month.\r\n      ","sponsor":"George Washington University","sponsor_type":"Other","conditions":"Dengue Fever","interventions":[{"intervention_type":"Drug","name":"Drug: Zanamivir","description":"Intravenous zanamivir"},{"intervention_type":"Other","name":"Other: Placebo","description":"In the placebo group, participants will receive placebo normal saline solution intravenously every twelve hours for 5 days."}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of Treatment-Emergent Adverse Events of intravenous zanamivir treatment versus placebo in dengue","time_frame":"Over 14 days","description":"Incidence of Treatment-Emergent Adverse Events will be assessed by daily active surveillance during drug administration and at 2-week follow-up as per the United States Food and Drug Administration guidelines."},{"outcome_type":"secondary","measure":"Levels of endothelial glycocalyx biomarkers in intravenous zanamivir treatment versus placebo in dengue","time_frame":"Over 14 days","description":"Serum concentration of key endothelial glycocalyx components due to endothelial damage such as sialic acid, heparan sulfate, and syndecan-1 will be assessed by ELISA.\r\nSerum concentration of sialidases (NEU2 and NEU3) that are directly inhibited by zanamivir will be assessed by ELISA."},{"outcome_type":"secondary","measure":"Preliminary clinical efficacy of intravenous zanamivir treatment versus placebo in dengue","time_frame":"Over 14 days","description":"Presence of moderate or severe plasma leakage as defined by the Standard Clinical Endpoints for Use in Dengue Interventional Trials where moderate plasma leakage is defined as 15% change in hematocrit or evidence of fluid on ultrasound or X-ray and severe plasma leakage is defined at the presence of shock or respiratory compromise with evidence of plasma leakage."}]}
{"nct_id":"NCT04530799","start_date":"2021-10-01","enrollment":350,"brief_title":"Prospective Observational Trial of IAPA","official_title":"Influenza-associated Pulmonary Aspergillosis (IAPA) in ICU Patients With Severe Influenza: Incidence and Host- and Pathogen Related Risk Factors","primary_completion_date":"2024-03-03","study_type":"Observational","rec_status":"Not yet recruiting","completion_date":"2024-03-03","last_update":"2021-06-04","description":"A prospective multi-center observational study to assess the incidence of influenza-associated pulmonary aspergillosis (IAPA) in ICU patients and to identify host- and pathogen related risk factors for IAPA in EORTC negative ICU patients with severe influenza.","other_id":"IAPAFLU","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"The target patient population is the EORTC-negative population of critically ill influenza\r\n        patients at ICU. Patient identification will rely on daily review of ICU patients with\r\n        respiratory virus panels ordered in the previous 24 hours.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with a PCR-positive respiratory virus panel (RVP) result for influenza within\r\n             96 hours before or 48 hours after ICU admission.\r\n\r\n          -  Patients who require ICU admission for more than 24 hours for severe influenza.\r\n\r\n          -  Patients who have respiratory distress (respiratory rate >= 25x/minute and paO2/fiO2 <\r\n             300 with or without bilateral infiltrates) as the main reason for ICU admission.\r\n\r\n          -  Patients who do not have an EORTC host factor.\r\n\r\n          -  Patients who are at least 18 years of age.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with age < 18 years as extensive sampling is required\r\n\r\n          -  Expected survival on ICU admission  48h\r\n\r\n          -  Patients that are being treated actively with antifungal agents for invasive\r\n             aspergillosis.\r\n\r\n          -  Patients or their legal representatives who did not sign the informed consent form\r\n      ","sponsor":"Radboud University","sponsor_type":"Other","conditions":"Influenza With Pneumonia|Pulmonary Aspergillosis","interventions":[{"intervention_type":"Other","name":"Other: Identification of biomarkers for IAPA via patient sampling","description":"Blood, BAL, microbiome"}],"outcomes":[{"outcome_type":"secondary","measure":"Length of ICU stay","time_frame":"from date of admission in ICU assessed up to ICU discharge, approximately 21 days"},{"outcome_type":"secondary","measure":"Length of hospital stay","time_frame":"from date of admission in hospital assessed up to hospital discharge, approximately 30 days"},{"outcome_type":"secondary","measure":"ICU mortality","time_frame":"up to ICU discharge, approximately 21 days"},{"outcome_type":"primary","measure":"The incidence of IAPA-infection at ICU discharge","time_frame":"from date of admission in ICU assessed up to ICU discharge, approximately 21 days","description":"The diagnosis of IAPA will be made by the treating physician, according to a strict case definition."},{"outcome_type":"secondary","measure":"Time to IAPA diagnosis","time_frame":"from date of admission in ICU assessed up to ICU discharge, approximately 21 days","description":"The diagnosis of IAPA will be made by the treating physician, according to a strict case definition."},{"outcome_type":"secondary","measure":"Hospital mortality","time_frame":"from date of admission in hospital assessed up to hospital discharge, approximately 30 days"},{"outcome_type":"secondary","measure":"30-day mortality","time_frame":"30 days"},{"outcome_type":"secondary","measure":"90-day mortality","time_frame":"90 days"}]}
{"nct_id":"NCT04859296","start_date":"2021-10-01","phase":"Phase 1","enrollment":20,"brief_title":"AnalgeSiC and appEtite-stimulating Effects of caNnabigerol and THC (ASCENT)","official_title":"Analgesic and Appetite-stimulating Effects of Cannabigerol Administered Alone and in Combination With Delta-9-tetrahydrocannabinol","primary_completion_date":"2024-04-01","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2025-04-01","last_update":"2021-09-02","description":"This study will assess the analgesic, appetite-stimulating, and subjective effects of cannabigerol (CBG) alone and in combination with THC.","other_id":"21-000208","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Basic Science","masking_description":"Double","intervention_model_description":"This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.","sampling_method":"","gender":"All","minimum_age":21,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or non-pregnant and non-lactating females aged 21-55 years\r\n\r\n          -  Report monthly use of cannabis (1 day per week) over the 6 months prior to screening,\r\n\r\n          -  Not currently seeking treatment for their cannabis use\r\n\r\n          -  Have a Body Mass Index from 18.5 - 34kg/m2.\r\n\r\n          -  Able to perform all study procedures\r\n\r\n          -  Must be using a contraceptive (hormonal or barrier methods)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Meeting DSM-V criteria for moderate-severe Cannabis Use disorder (CUD) or any\r\n             substance use disorder other than nicotine, caffeine, or mild CUD\r\n\r\n          -  Any other Axis I disorder\r\n\r\n          -  Report using other illicit drugs in the prior 4 weeks\r\n\r\n          -  Current use of prescription analgesics, or any medications that may affect study\r\n             outcomes\r\n\r\n          -  If medical history, physical and psychiatric examination, or laboratory tests\r\n             performed during the screening process are not within the normal range and / or reveal\r\n             any significant illness (e.g., hypertension) as judged by the study physician and to\r\n             put the participant at greater risk of experiencing adverse events due to completion\r\n             of study procedures.\r\n\r\n          -  Current pain\r\n\r\n          -  Pregnancy is exclusionary due to the possible effects of the study medication on fetal\r\n             development.\r\n\r\n          -  History of an allergic reaction or adverse reaction to cannabis is exclusionary.\r\n\r\n          -  History of respiratory illness or current respiratory illness\r\n\r\n          -  Currently enrolled in another research protocol\r\n\r\n          -  Not using a contraceptive method (hormonal or barrier methods)\r\n\r\n          -  Insensitivity to the cold water stimulus of the Cold Pressor Test\r\n\r\n          -  Any disorders that might make cannabis administration hazardous are exclusionary, as\r\n             determined by the evaluating physician\r\n      ","sponsor":"University of California, Los Angeles","sponsor_type":"Other","conditions":"Pain|Appetite Loss|Abuse, Drug","interventions":[{"intervention_type":"Drug","name":"Drug: Placebo","description":"Vaporized placebo"},{"intervention_type":"Drug","name":"Drug: Low CBG","description":"Vaporized CBG (10 mg)"},{"intervention_type":"Drug","name":"Drug: High CBG","description":"Vaporized CBG (30 mg)"},{"intervention_type":"Drug","name":"Drug: Low THC","description":"Vaporized THC (5 mg)"},{"intervention_type":"Drug","name":"Drug: High THC","description":"Vaporized THC (15 mg)"}],"outcomes":[{"outcome_type":"primary","measure":"Analgesia","time_frame":"7 hours","description":"Pain threshold and pain tolerance assessed with the Cold Pressor Test - time to report first feeling pain (0-180 seconds) and remove the hand from the cold water (0-180 seconds). Increased duration means increased pain tolerance and pain threshold."},{"outcome_type":"primary","measure":"Appetite stimulation","time_frame":"7 hours","description":"Subjective ratings of hunger assessed with a visual analog scale (0-100 mm; 0 mm = no effect, 100 mm = maximum possible effect). Higher ratings indicate higher ratings of hunger / appetite stimulation."},{"outcome_type":"primary","measure":"Abuse liability","time_frame":"7 hours","description":"Subject ratings of \"Good Drug Effect\" as measured using a visual analog scale (0-100 mm; 0 mm = no effect, 100 mm = maximum possible effect). Higher ratings indicate higher ratings of abuse liability."},{"outcome_type":"secondary","measure":"Subjective ratings of intoxication","time_frame":"7 hours","description":"Subject ratings of \"High\" as measured using a visual analog scale (0-100 mm; 0 mm = no effect, 100 mm = maximum possible effect). Higher ratings indicate higher ratings of intoxication."},{"outcome_type":"secondary","measure":"Subjective ratings of pain","time_frame":"7 hours","description":"Subject ratings of Painfulness and Bothersomeness of the Cold Pressor Test. Scale is from 0 (Not painful / bothersome at all) to 10 (The most painful / bothersome feeling imaginable), higher ratings indicate greater painfulness and bothersomeness."}]}
{"nct_id":"NCT04681339","start_date":"2021-09-30","enrollment":200,"brief_title":"Antibiotic Prescription in Children Hospitalized for Community-acquired Pneumonia","official_title":"Antibiotic Prescription in Children Hospitalized for Community-acquired Pneumonia: a Prospective, Observational Study","primary_completion_date":"2024-11-30","study_type":"Observational","rec_status":"Not yet recruiting","completion_date":"2024-12-31","last_update":"2021-05-10","description":"A study to observe how often antibiotics are prescribed in children hospitalized for pneumonia and how doctors decide if a child needs antibiotics or not. Parent satisfaction will also be recorded.","other_id":"PKA-03","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":0.25,"maximum_age":18,"population":"Children (aged 3 months to 18 years) who are hospitalized for pneumonia.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Hospital admission at the pediatric department of the Filderklinik or at the pediatric\r\n             department of the Herdecke Community Hospital\r\n\r\n          -  Admission diagnosis pneumonia or pneumonia diagnosis within 48 hours of admission\r\n\r\n          -  Written informed consent by care giver\r\n\r\n          -  All inclusion criteria have to be fulfilled\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Insufficient knowledge of German to understand the written patient information and\r\n             questionnaire\r\n      ","sponsor":"ARCIM Institute Academic Research in Complementary and Integrative Medicine","sponsor_type":"Other","conditions":"Community Acquired Pneumonia in Children|Antibiotic Stewardship","interventions":[{"intervention_type":"Other","name":"Other: Antibiotic treatment","description":"Antibiotic treatment"},{"intervention_type":"Other","name":"Other: No antibiotic treatment","description":"No antibiotic treatment"}],"outcomes":[{"outcome_type":"primary","measure":"Antibiotic treatment rates in hospitalized children with non-severe community-acquired pneumonia and fever","time_frame":"During hospitalization, an average of 7 days","description":"Rates of treatment with and without antibiotics during hospitalization"},{"outcome_type":"secondary","measure":"Number of medical complications","time_frame":"During hospitalization, an average of 7 days","description":"Medical complications defined as a) admission to intensive care, mechanical ventilation, transfer to tertiary car center OR b) pleural effusion or empyema, pneumothorax, lung abscess, bronchopleural fistula, necrotizing pneumonia, acute respiratory failure, infectious complication (meningitis, septic shock)."},{"outcome_type":"secondary","measure":"Factors in physician decision making on antibiotic prescription","time_frame":"During hospitalization, an average of 7 days","description":"Physician questionnaire (closed-ended questions)"},{"outcome_type":"secondary","measure":"Parental satisfaction","time_frame":"At discharge, assessing the entire duration of the hospital stay, an average of 7 days","description":"Parental satisfaction questionnaire (closed-ended questions)"},{"outcome_type":"secondary","measure":"Hospitalization duration","time_frame":"At discharge, assessing the entire duration of the hospital stay, an average of 7 days","description":"Number of hospitalization days"},{"outcome_type":"secondary","measure":"Number of children with relevant comorbidity","time_frame":"During hospitalization, an average of 7 days","description":"Co-morbidities that may affect decision on antimicrobial use: a) chronic conditions (e.g. neurological conditions such as cerebral palsy, Down syndrome; or chronic respiratory conditions such as asthma, cystic fibrosis; or heart conditions). b) acute infectious comorbidities: bronchiolitis, otitis media, urinary tract infection, confirmed influenza virus or Respiratory Syncytial Virus or SARS-CoV2."},{"outcome_type":"secondary","measure":"Days of supplemental oxygen use","time_frame":"During hospitalization, an average of 7 days","description":"Oxygen therapy for O2 saturation <92%"},{"outcome_type":"secondary","measure":"Use of antipyretic medications","time_frame":"During hospitalization, an average of 7 days","description":"Number of doses of paracetamol or ibuprofen during hospitalization"},{"outcome_type":"secondary","measure":"Number of complementary medicine medications used per child","time_frame":"During hospitalization, an average of 7 days","description":"Number of complementary medication during hospitalization"},{"outcome_type":"secondary","measure":"Number of readmissions for pneumonia or new pneumonia recurrences within 4 weeks of hospital discharge","time_frame":"4 weeks after end of hospitalization","description":"New hospital admission for pneumonia; treatment requiring recurrence of pneumonia"}]}
{"nct_id":"NCT05039372","start_date":"2021-09-30","phase":"N/A","enrollment":74,"brief_title":"Rheumatoid Arthritis, Planned Behavor Theory And Nurse Counselng","official_title":"The Effect Of Nurse Counselng Appled Accordng To Planned Behavor Theory On Pan, Fatgue And Functonal Status In Patents Wth Rheumatoid Arthritis","primary_completion_date":"2022-12-30","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2023-01-30","last_update":"2021-09-09","description":"Ensuring disease management begins with comprehensive education and drug therapy. Symptoms such as deformities, pain and fatigue, which are most common in rheumatoid arthritis patients, seriously affect the daily activities of the patients. In order to improve the quality of life of the patient, it is essential that he receives planned education about his disease and constant follow up it like this helps him manage his disease by providing behavioral changes. There are similar studies on chronic diseases in the literature, and it has been seen to make a positive contribution. Studies have shown that patient education includes only information, counseling or behavioral therapies, and does not necessarily turn into behavior change on its own. Which was developed on the basis of education and human behavior theories, According to The Theory of Planned Behavior it is thought that patients can cope with their illnes, manage their illnesses and show behavioral changes by adapting to the illness with the help of nursing counseling. The importance of patient follow-up has once again come to the fore when it comes to the problems that those with chronic diseases may experience during the pandemic process and the difficulties in finding solutions. Recently, training and follow-up are carried out with remote access in the management of many chronic diseases. Especially in chronic diseases such as rheumatoid arthritis, which affects all systems, the counseling service to be provided to the extent that behavior change can be achieved has become more important. In this direction, it is thought that it will be beneficial in the long term for patients to gain behavioral changes by telephone monitoring after education.","other_id":"interventional","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","intervention_model_description":"experimental randomized controlled","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":64,"population":"","criteria":"\n        Criteria:\r\n\r\n        Inclusion Criteria for Research\r\n\r\n          -  Between 18 and 64 years old\r\n\r\n          -  Diagnosed with Rheumatoid Arthritis at least 6 months ago,\r\n\r\n          -  Can communicate in Turkish and does not have a cognitive problem that prevents\r\n             communication,\r\n\r\n          -  No neurological or psychiatric disease without malignancy,\r\n\r\n          -  Without heart failure (stages III and IV according to NYHA)\r\n\r\n          -  Not pregnant,\r\n\r\n          -  Able to use a telephone,\r\n\r\n          -  Patients who volunteer to participate in the study will be included in the study.\r\n\r\n        Exclusion Criteria\r\n\r\n          -  Under 18 years old,\r\n\r\n          -  Newly diagnosed, treated for less than 6 months,\r\n\r\n          -  Having a malignant type of disease,\r\n\r\n          -  Patients who do not volunteer to participate in the study will not be included.\r\n      ","sponsor":"Hasan Kalyoncu University","sponsor_type":"Other","conditions":"Rheumatoid Arthritis","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: TRAINING AND CONSULTANCY","description":"TRAINING AND CONSULTANCY"}],"outcomes":[{"outcome_type":"primary","measure":"Evaluation of Fatigue in a Rheumatoid Arthritis Patient","time_frame":"0","description":"Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire (BRAF-MDQ): It was developed to evaluate the effect of fatigue in different dimensions in patients with rheumatoid arthritis. There are 20 questions in total. Total BRAF-MDQ scores range from 0 to 70. Higher scores indicate higher fatigue."},{"outcome_type":"primary","measure":"Evaluation of Pain in a Rheumatoid Arthritis patient","time_frame":"0","description":"McGill Pain Scale Short Form (MAS-SF): The scale provides information about the sensory characteristics, severity and effect of pain. The main component of the scale consists of 15 descriptive adjectives for sensation of pain and is self-rated by the patient according to the level of intensity on a scoring scale (0 = none, 1 = mild, 2 = moderate, 3 = severe)."},{"outcome_type":"primary","measure":"Evaluation of Patient-Reported Pain","time_frame":"3 months","description":"McGill Pain Scale Short Form (MAS-SF): The scale provides information about the sensory characteristics, severity and effect of pain. The main component of the scale consists of 15 descriptive adjectives for sensation of pain and is self-rated by the patient according to the level of intensity on a scoring scale (0 = none, 1 = mild, 2 = moderate, 3 = severe)."},{"outcome_type":"primary","measure":"Evaluation of Patient-Reported Fatigue","time_frame":"3 months","description":"Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire (BRAF-MDQ): It was developed to evaluate the effect of fatigue in different dimensions in patients with rheumatoid arthritis. There are 20 questions in total. Total BRAF-MDQ scores range from 0 to 70. Higher scores indicate higher fatigue."},{"outcome_type":"primary","measure":"Evaluation of Functional Status in a Rheumatoid Arthritis patient","time_frame":"0","description":"Stanford Health Assessment Scale (HAQ): The Health Assessment Scale is a functional measurement method that is frequently used to evaluate the functional status of rheumatology patients in their daily lives. The scale consists of 20 items in the form of 8 sections. A high score on the scale indicates functional disability."},{"outcome_type":"primary","measure":"Assessment of Patient-Reported Functional Status","time_frame":"3 months","description":"Stanford Health Assessment Scale (HAQ): The Health Assessment Scale is a functional measurement method that is frequently used to evaluate the functional status of rheumatology patients in their daily lives. The scale consists of 20 items in the form of 8 sections. A high score on the scale indicates functional disability."}]}
{"nct_id":"NCT04963179","start_date":"2021-09-30","phase":"N/A","enrollment":154,"brief_title":"PREvention of Intrauterine Adhesion After Adhesiolysis With Novel Tri-block deGradable Polymer Film.","official_title":"PREvention of Intrauterine Adhesion After Adhesiolysis With Novel Tri-block deGradable Polymer Film.","primary_completion_date":"2023-03-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2024-09-30","last_update":"2021-07-15","description":"PREG2 is a randomized controlled trial that aims to evaluate efficacy in preventing intrauterine adhesion recurrence after hysteroscopic adhesiolysis of a novel intrauterine barrier film named Womed Leaf","other_id":"PREG2","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Women with moderate or severe intrauterine adhesions according to the AFS\r\n             classification, i.e AFS score >=5, confirmed by hysteroscopy right before adhesiolysis\r\n\r\n          -  Scheduled for hysteroscopic adhesiolysis\r\n\r\n          -  Age above or equal to 18\r\n\r\n          -  Subjects who are willing to provide a written informed consent.\r\n\r\n          -  Subjects who can comply with the study follow-up (second look hysteroscopy) and other\r\n             study requirements\r\n\r\n        Exclusion Criteria:\r\n\r\n        Pre-operative criteria\r\n\r\n          -  Post menopause\r\n\r\n          -  Abnormal uterine cavity according to ESHRE classification I to V such as unicornis,\r\n             bicornis, septate, duplex\r\n\r\n          -  Known or suspected endometrial hyperplasia\r\n\r\n          -  History of cervical or endometrial cancer\r\n\r\n          -  Active pelvic infection or history of pelvic peritonitis\r\n\r\n          -  History of endometrial ablation\r\n\r\n          -  Known contraindication or hypersensitivity to Womed Leaf component\r\n\r\n          -  Current participation in another clinical investigation that has not yet received the\r\n             primary endpoint.\r\n\r\n          -  Any other condition that makes participation in the study contrary to the patient's\r\n             best interests.\r\n\r\n        Intra-operative criteria, post adhesiolysis:\r\n\r\n          -  Perforation during adhesiolysis\r\n\r\n          -  Uterine depth < 5cm or > 10cm\r\n      ","sponsor":"Womed","sponsor_type":"Industry","conditions":"Asherman Syndrome|Intrauterine Adhesion","interventions":[{"intervention_type":"Device","name":"Device: Womed Leaf","description":"Womed Leaf device is composed of a uterine anti-adhesion film pre-loaded inside a flexible inserter.\r\nWomed Leaf is inserted in the uterine cavity by the gynecologist surgeon as a film folded into a 5 mm diameter flexible inserter. Once released, the film will unfold and swell into the uterine cavity to keep uterus walls separated during approximately 5 days. It is degraded and discharged naturally through the cervix and vagina in less than 30 days."}],"outcomes":[{"outcome_type":"primary","measure":"Efficacy - IUA severity","time_frame":"At second look hysteroscopy between 4 and 8 weeks","description":"Change of AFS score between pre-adhesiolysis and second-look hysteroscopy (AFS) score"},{"outcome_type":"primary","measure":"Safety - Adverse events","time_frame":"At second look hysteroscopy between 4 and 8 weeks","description":"The number, severity and type of adverse events at second look hysteroscopy."},{"outcome_type":"secondary","measure":"Freedom from IUA","time_frame":"At second look hysteroscopy between 4 and 8 weeks","description":"Rate of IUA"},{"outcome_type":"secondary","measure":"IUA severity at second look","time_frame":"At second look hysteroscopy between 4 and 8 weeks","description":"Average of AFS scores at second look hysteroscopy"},{"outcome_type":"secondary","measure":"IUA severity after adhesiolysis","time_frame":"Just after adhesiolysis","description":"Average of AFS scores post adhesiolysis"},{"outcome_type":"secondary","measure":"AFS score components","time_frame":"At second look hysteroscopy between 4 and 8 weeks","description":"Average of each component of AFS score: extent of IUA, type of IUA and menstrual pattern"},{"outcome_type":"secondary","measure":"Change in AFS score components","time_frame":"At second look hysteroscopy between 4 and 8 weeks","description":"Average of the change in each component of AFS score between post-adhesiolysis and second look hysteroscopy"},{"outcome_type":"secondary","measure":"Change in AFS score","time_frame":"At second look hysteroscopy between 4 and 8 weeks","description":"Change of AFS score between post-adhesiolysis and second-look hysteroscopy"},{"outcome_type":"secondary","measure":"IUA severity according to ESGE classification","time_frame":"At second look hysteroscopy between 4 and 8 weeks","description":"Median of ESGE stage at second look hysteroscopy"},{"outcome_type":"secondary","measure":"Reintervention rate","time_frame":"1 year","description":"Reintervention rate, during second look hysteroscopy or scheduled later up to one year"},{"outcome_type":"secondary","measure":"Number of re-intervention procedures","time_frame":"1 year","description":"Number of adhesiolysis procedures after second look up to one year"},{"outcome_type":"secondary","measure":"Pregnancy rate","time_frame":"1 year","description":"Pregnancy rate defined as presence of foetal sac or heartbeat by ultrasound, whether spontaneous or IVF"},{"outcome_type":"secondary","measure":"Pregnancy rate","time_frame":"2 years","description":"Pregnancy rate defined as presence of foetal sac or heartbeat by ultrasound, whether spontaneous or IVF"},{"outcome_type":"secondary","measure":"Live birth","time_frame":"1 year","description":"Live birth rate"},{"outcome_type":"secondary","measure":"Live birth","time_frame":"2 years","description":"Live birth rate"},{"outcome_type":"secondary","measure":"Pregnancy complication","time_frame":"2 years","description":"Pregnancy complication rate"},{"outcome_type":"secondary","measure":"Time to pregnancy","time_frame":"2 years","description":"Time to pregnancy (i.e. time between the second look hysteroscopy and pregnancy start)"},{"outcome_type":"secondary","measure":"Improvement of IUA severity","time_frame":"At second look hysteroscopy between 4 and 8 weeks","description":"Percentage of patients who have improvement on the IUA severity according to Clinical Category:\r\nPercentage of patients who have Mild adhesions or no adhesion at second look Percentage of patients who improved from Severe to Moderate or from Moderate to Mild Percentage of patients who improved from Severe to Mild"}]}
{"nct_id":"NCT05016271","start_date":"2021-09-30","phase":"N/A","enrollment":110,"brief_title":"Health Benefits of Air Purifiers in Primary School Students","official_title":"Health Benefits of Air Purifiers in Primary School Students: A Randomized Controlled Trial","primary_completion_date":"2022-01-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2022-02-28","last_update":"2021-08-27","description":"This study aims to explore changes in cardiopulmonary function and other health indicators in primary school students with the intervention of air purifiers on a randomized controlled trial.","other_id":"FDUEH-7","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":8,"maximum_age":12,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age of between 8 and 12 years old\r\n\r\n          -  Males and female of ethnic Han\r\n\r\n          -  Subjects who have no plans to change classroom during the intervention period\r\n\r\n          -  Subjects who staying in Jiaozuo city during the intervention period\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subjects with asthma, childhood diabetes, childhood hypertension, and behavioral\r\n             disorders\r\n\r\n          -  Subjects who plan to transfer or move offsite within six months\r\n\r\n          -  Subjects who decorated or plan to decorate home within six months\r\n\r\n          -  Subjects with smokers in the household\r\n      ","sponsor":"Fudan University","sponsor_type":"Other","conditions":"Cardiopulmonary Function|Child","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Air purifier and fresh air ventilation systems with high-efficiency particulate air (HEPA) filters","description":"This group will receive an intervention of true air purifiers. The air purifiers in classroom (air purifiers and fresh air ventilation systems with HEPA filters) will operate during the school time and the air purifiers in bedrooms (air purifiers with HEPA filters) operate during the home time in the intervention period (4 months anticipated)."},{"intervention_type":"Behavioral","name":"Behavioral: Air purifier and fresh air ventilation systems without high-efficiency particulate air (HEPA) filters","description":"This group will receive an intervention of sham air purifiers. The air purifiers in classroom (air purifiers and fresh air ventilation systems without HEPA filters) will operate during the school time and the air purifiers in bedrooms (air purifiers without HEPA filters) operate during the home time in the intervention period (4 months anticipated)."}],"outcomes":[{"outcome_type":"primary","measure":"Changes of heart rate variability","time_frame":"Baseline and after the completion of intervention period (4 months anticipated)","description":"Nihon Kohden Electrocardiograph and Carepatch Electrocardiogram are used to measure heart rate variability, including standard deviation of all normal-to-normal R-R intervals (SDNN), standard deviation of sequential five-minute R-R interval means (SDANN), root-mean-square difference of successive normal R-R intervals (RMSSD), low frequency (LF), and high frequency (HF) in intervention and control groups. To eliminate possible errors, measurements are conducted by the same trained staff using the same instrument."},{"outcome_type":"primary","measure":"Changes of forced expiratory volume in 1 s (FEV1)","time_frame":"Baseline and after the completion of intervention period (4 months anticipated)","description":"The pulmonary function measures are performed by the professional medical device. Before the pulmonary function test, subjects practice several times with the guidance of professional staff. During the examination, each subject in a sitting position and clamp the nose clip, and repeat the test, with the best result as the criterion."},{"outcome_type":"primary","measure":"Changes of forced vital capacity (FVC)","time_frame":"Baseline and after the completion of intervention period (4 months anticipated)","description":"The pulmonary function measures are performed by the professional medical device. Before the pulmonary function test, subjects practice several times with the guidance of professional staff. During the examination, each subject in a sitting position and clamp the nose clip, and repeat the test, with the best result as the criterion."},{"outcome_type":"primary","measure":"Changes of forced expiratory volume in 1 s (FEV1) / forced vital capacity (FVC) ratio","time_frame":"Baseline and after the completion of intervention period (4 months anticipated)","description":"The pulmonary function measures are performed by the professional medical device. Before the pulmonary function test, subjects practice several times with the guidance of professional staff. During the examination, each subject in a sitting position and clamp the nose clip, and repeat the test, with the best result as the criterion."},{"outcome_type":"primary","measure":"Changes of peak expiratory flow (PEF)","time_frame":"Baseline and after the completion of intervention period (4 months anticipated)","description":"The pulmonary function measures are performed by the professional medical device. Before the pulmonary function test, subjects practice several times with the guidance of professional staff. During the examination, each subject in a sitting position and clamp the nose clip, and repeat the test, with the best result as the criterion."},{"outcome_type":"primary","measure":"Changes of fractional exhaled nitric oxide (FeNO) levels","time_frame":"Baseline and after the completion of intervention period (4 months anticipated)","description":"A NIOX VERO Sensor is used to measure fractional exhaled nitric oxide (FeNO) as a biomarker for airway inflammation. After deep breathing, the subjects gently inhaled into the device. The instrument shows FeNO level of the subjects."},{"outcome_type":"primary","measure":"Changes of fractional exhaled carbon monoxide (FeCO) levels","time_frame":"Baseline and after the completion of intervention period (4 months anticipated)","description":"Use PICO to measure fractional exhaled carbon monoxide (FeCO) as a biomarker for cardiovascular risk. After deep breathing and holding the breath for 15 seconds, the subjects gently inhaled into the device. The instrument shows FeCO level of the subjects."},{"outcome_type":"primary","measure":"Changes of blood pressure","time_frame":"Baseline and after the completion of intervention period (4 months anticipated)","description":"Using Omron blood pressure monitor to measure the systolic blood pressure (SBP), diastolic blood pressure (DBP), and pulse pressure for each subject by the trained staff using the same instrument."},{"outcome_type":"secondary","measure":"Changes of C-reactive protein (CRP)","time_frame":"Baseline and after the completion of intervention period (4 months anticipated)","description":"Detect the concentration of C-reactive protein (CRP) in blood sample to examine the different level of inflammation between the groups of intervention and control."},{"outcome_type":"secondary","measure":"Changes of 8-hydroxydeoxyguanosine (8-OHdG)","time_frame":"Baseline and after the completion of intervention period (4 months anticipated)","description":"Detect the concentration of 8-hydroxydeoxyguanosine (8-OHdG) in urine sample of groups of intervention and control. 8-OHdG is a biomarker for DNA oxidative damage."},{"outcome_type":"secondary","measure":"Changes of persistent response (PR)","time_frame":"Baseline and after the completion of intervention period (4 months anticipated)","description":"Examine persistent response (PR) as the index to test the focus ability of children. The test is performed by the Wisconsin Card Sorting Test (WCST) through a computer, and the index reflects the ability of cognitive transfer. The normal value is less than or equal to 27."},{"outcome_type":"secondary","measure":"Differences in metabolite levels detected in metabolomics between groups of intervention and control.","time_frame":"Baseline and after the completion of intervention period (4 months anticipated)","description":"Mass spectrometry-based serum metabolomics is non-targeted. The study is to explore the differential metabolites in blood/urine/exhaled breath condensate (EBC) samples of the groups of intervention and control."}]}
{"nct_id":"NCT04661280","start_date":"2021-09-30","phase":"Phase 3","enrollment":240,"brief_title":"Donepezil Versus Non-drug Treatment in Alzheimer's Disease.","official_title":"Donepezil Use Versus Non-drug Approach in Treatment of Newly Diagnosed Alzheimer's Disease : a Multicentric, Randomized, Open Study : the CHOLINE-2 Study","primary_completion_date":"2023-09-30","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2024-03-31","last_update":"2021-07-20","description":"Donepezil, as well as the other symptomatic drugs of Alzheimer's disease, is not any more reimbursed by the French healthcare system, due to a controversy about its efficiency. French health authorities currently preconize a non-rug approach based on cognitive remediation or stimulation. The aim of this study is to compare the efficiency of the 2 approaches (non-drug versus donepezil) on the symptoms of Alzheimer's disease after 6 months of treatment.","other_id":"APHP201183","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosis of Alzheimer's disease according to the IWG-2 criteria.\r\n\r\n          -  Age  50 years.\r\n\r\n          -  Absence of legal protection measures (guardianship, curatorship).\r\n\r\n          -  MMSE score  10 at inclusion.\r\n\r\n          -  abnormal values for A42 in the CSF or A40 / A42 ratio.\r\n\r\n          -  abnormal values for phosphorylated Tau in CSF\r\n\r\n          -  Presence of a family carer or a person at home who can ensure compliance with\r\n             treatment if MMSE score <20.\r\n\r\n          -  French native speaker.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Other cause of dementia.\r\n\r\n          -  Previous use of symptomatic treatment for Alzheimer's disease.\r\n\r\n          -  Hypersensitivity to donepezil hydrochloride or to any of the excipients listed in the\r\n             SPC.\r\n\r\n          -  Cardiological contraindication after possible opinion of a cardiologist, at the\r\n             initiative of the investigator, in particular bradycardia, sinus disease or other\r\n             supra-ventricular conduction abnormalities such as sinoatrial or atrioventricular\r\n             block.\r\n\r\n          -  Patients at particular risk of ulcer, known ulcer disease or receiving concomitant\r\n             treatment with non-steroidal anti-inflammatory drugs.\r\n\r\n          -  Patient at risk of urinary retention.\r\n\r\n          -  History of epileptic disease.\r\n\r\n          -  History of neuroleptic malignant syndrome.\r\n\r\n          -  History of asthma or obstructive bronchopulmonary disease.\r\n\r\n          -  Severe hepatic impairment.\r\n\r\n          -  Taking one of the following treatments:\r\n\r\n               -  CYP3A4 inhibitors, such as ketonazole.\r\n\r\n               -  2D6 inhibitors, such as quinidine.\r\n\r\n               -  CYP3A4 inhibitors, such as itraconazole and erythromycin.\r\n\r\n               -  CYP2D6 inhibitors, such as fluoxetine.\r\n\r\n               -  Enzyme inducers such as rifampicin, phenytoin, carbamazepine.\r\n\r\n          -  Participation in another interventional study.\r\n      ","sponsor":"Assistance Publique - Hpitaux de Paris","sponsor_type":"Other","conditions":"Alzheimer Disease, Early Onset","interventions":[{"intervention_type":"Drug","name":"Drug: Donepezil","description":"Donepezil 5 mg per day during one month, then 10 mg per day during 5 months."}],"outcomes":[{"outcome_type":"primary","measure":"Difference of change in the MMSE score","time_frame":"26 weeks","description":"Difference of change in the MMSE score between baseline and 26 weeks in the 2 ams (donepezil versus non-drug). MMSE is measured at baseline, 6 weeks, 13 weeks, and 26 weeks."},{"outcome_type":"secondary","measure":"Difference of change in the ADAS-Cog scale","time_frame":"26 weeks","description":"Difference of change in the ADAS-Cog scale between baseline and 26 weeks in the 2 ams (donepezil versus non-drug).\r\nADAS-Cog scale = Alzheimer's Disease Assessment Scale-Cognitive Subscale, scored from 0 to 70"},{"outcome_type":"secondary","measure":"Difference of change in the CDR scale","time_frame":"26 weeks","description":"Difference of change in the CDR scale between baseline and 26 weeks in the 2 ams (donepezil versus non-drug).\r\nCDR scale = Clinical Dementia Rating, scored from 0 to 3"},{"outcome_type":"secondary","measure":"Difference of change in the ADL scale","time_frame":"26 weeks","description":"Difference of change in the ADL scale between baseline and 26 weeks in the 2 ams (donepezil versus non-drug).\r\nADL scale = Autonomy scale on daily activities, scored from 0 to 78"},{"outcome_type":"secondary","measure":"Difference of change in the quality of life scale","time_frame":"26 weeks","description":"Difference of change in the quality of life scale between baseline and 26 weeks in the 2 ams (donepezil versus non-drug)."},{"outcome_type":"secondary","measure":"Difference of change in the ZARIT scale","time_frame":"26 weeks","description":"Difference of change in the ZARIT scale between baseline and 26 weeks in the 2 ams (donepezil versus non-drug).\r\nZARIT scale = for assessing caregiver burden, scored from 0 to 88"}]}
{"nct_id":"NCT04188119","start_date":"2021-09-30","phase":"Phase 2","enrollment":42,"brief_title":"A Proof of Concept Window Trial of the IMmunological Effects of AveLumab and Aspirin in Triple-Negative Breast Cancer","official_title":"A Proof of Concept Window Trial of the IMmunological Effects of AveLumab and Aspirin in Triple-Negative Breast Cancer","primary_completion_date":"2022-08-30","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2022-08-30","last_update":"2021-05-17","description":"This research is being done because the investigators are looking for new and better ways to treat a type of breast cancer called triple negative breast cancer. This type of breast cancer can be more difficult to treat than other types of breast cancer as it does not respond to drugs such as hormonal therapies. One type of treatment that looks promising is immunotherapy using new drugs called immune checkpoint inhibitors. Immune checkpoints help to regulate the immune system and can stop the immune system from attacking cancer cells. Immune checkpoint inhibitors block this 'off-switch' and aim to help the immune system control the cancer. These drugs have been very effective in other cancers such as melanoma and are now being tested in breast cancer. In this study patients will receive an immune checkpoint inhibitor called avelumab. Half the patients on the study will also receive aspirin tablets for approximately 18 days as the investigators wish to compare the effects of avelumab alone versus in combination with aspirin. Patients will attend hospital approximately five times in order to complete all necessary study assessments. The first visit screens patients for suitability, after which a baseline visit will collect the first of two breast tissue biopsies. At the third visit a single dose of Avelumab will be given via an infusion (a drip in the forearm). Patients will then return approximately two weeks later for a second breast tissue biopsy before having a final follow up visit another two weeks later. Blood and urine samples will be taken at various visits throughout the study to help us learn more about the effects these treatments may have on the immune system and on breast cancer cells.","other_id":"CFT / sp123","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","intervention_model_description":"Patients will be randomly assigned to one of two arms:-\r\n21 patients into Arm A: Avelumab + Proton Pump Inhibitor (PPI)\r\n21 patients into Arm B: Avelumab + Aspirin + PPI","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Written informed consent, willing and able to comply with the trial protocol for the\r\n             duration of the trial including all treatments and scheduled biopsies.\r\n\r\n          2. Female patients, age 18 and over\r\n\r\n          3. Histologically confirmed triple negative invasive breast cancer as defined as\r\n             oestrogen receptor (ER) negative, progesterone receptor (PgR) negative (if available,\r\n             otherwise PgR unknown), (as defined by Allred score 0- 2 or <1% of tumour cells\r\n             positive for stain) and HER2 negative (immunohistochemistry 0/1+ or negative by in\r\n             situ hybridization) as determined by local laboratory. Have previously untreated,\r\n             nonmetastatic TNBC with a tumour amenable to multiple biopsies including a T stage of\r\n             at least T2. Note multifocal primary tumours are allowed providing at least one tumour\r\n             meets the criteria above. All biopsies should be obtained from the same tumour.\r\n\r\n          4. Have previously untreated, non-metastatic TNBC with a tumour amenable to multiple\r\n             biopsies including a T stage of at least T2. Note multifocal primary tumours are\r\n             allowed providing at least one tumour meets the criteria above. All biopsies should be\r\n             obtained from the same tumour.\r\n\r\n          5. ECOG performance status 0/1\r\n\r\n          6. Women of childbearing potential (WOCBP), defined as not surgically sterilized or not\r\n             post-menopausal for at least 24 months if age 55 years or 12 months if age >55 years,\r\n             must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or\r\n             equivalent units of HCG) within 14 days prior to the start of either IMP study\r\n             treatment (Avelumab, and Aspirin if applicable).\r\n\r\n          7. Adequate organ function:\r\n\r\n               1. Adequate Hepatic function:\r\n\r\n                    -  AST and ALT <2.5x ULN\r\n\r\n                    -  Alkaline phosphatase 2 x ULN\r\n\r\n                    -  Total Bilirubin within normal range i.e. 1.5 x ULN. If AST/ ALT and\r\n                       Alkaline phosphatase are within normal limits then isolated elevation of\r\n                       bilirubin to 3 ULN and a presumptive diagnosis of Gilbert's syndrome is\r\n                       permitted.\r\n\r\n               2. Adequate organ function as defined by:\r\n\r\n                    -  Bone marrow function: Hb 100g/L\r\n\r\n                    -  Absolute neutrophil count 1.5 x 109/L\r\n\r\n                    -  Platelets 100 x 109/L\r\n\r\n                    -  Hemoglobin >9 g/dL\r\n\r\n                    -  Renal function: Creatinine 1.5 x ULN OR > 50ml/min using the\r\n                       Cockcroft-Gault formula (appendix 4).\r\n\r\n        Exclusion Criteria:\r\n\r\n        Patients meeting any of the following criteria must not be enrolled in the study:\r\n\r\n          1. Prior systemic anti-cancer treatment (immune therapy, targeted therapy, vaccine\r\n             therapy, or investigational treatment) for triple negative breast cancer.\r\n\r\n          2. Current use of a prohibited medication as described in section 7.11.\r\n\r\n          3. Malignancy within the last 5 years except: adequately treated nonmelanoma skin cancer;\r\n             curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS);\r\n             stage 1, grade I endometrial carcinoma.\r\n\r\n          4. Has received a live vaccine within 30 days of the first dose of study treatment. NB\r\n             Seasonal influenza vaccines are generally inactivated flu vaccines and are allowed;\r\n             intranasal influenza vaccines (eg FluMist) are live attenuated vaccines and are not\r\n             allowed.\r\n\r\n          5. Contraindications to aspirin dosing including hypersensitivity to aspirin (eg known\r\n             aspirin sensitive asthma; history of peptic ulcer disease, gastric bleeding or\r\n             cerebrovascular haemorrhages; haemorrhagic diathesis.\r\n\r\n          6. Evidence of distant metastases apparent prior to randomisation. Patients who are\r\n             diagnosed with distant metastases during the course of the study can complete study\r\n             procedures if willing to do so.\r\n\r\n          7. Significant cardiovascular disease including a history of myocardial infarction, acute\r\n             coronary syndrome or coronary angioplasty/stenting/ bypass grafting within the last 6\r\n             months or clinically significant congestive heart failure.\r\n\r\n          8. Any other serious or unstable pre-existing medical conditions (aside from malignancy\r\n             exceptions specified above), psychiatric disorders, or other conditions that in the\r\n             opinion of the investigator could interfere with the patient's safety, obtaining\r\n             informed consent, or compliance with study procedures.\r\n\r\n          9. Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C\r\n             Virus (HCV) infection (patients with laboratory evidence of cleared or chronic (not\r\n             active) HBV and HCV infection will be permitted).\r\n\r\n         10. Patients with active, known or suspected autoimmune disease. Patients with type 1\r\n             diabetes mellitus, hypothyroidism only requiring hormone replacement, skin or\r\n             rheumatological disorders (such as vitiligo, psoriasis, rheumatoid arthritis or\r\n             alopecia) not requiring systemic treatment, or conditions not expected to recur in the\r\n             absence of an external trigger will be permitted to enrol. Autoimmune conditions such\r\n             as ulcerative colitis that have been definitively treated (e.g. with total colectomy)\r\n             will be permitted to enrol but should be discussed with the CI.\r\n\r\n         11. Patients with a condition requiring systemic treatment with either corticosteroids\r\n             (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14\r\n             days of study drug administration. Inhaled or topical steroids and adrenal replacement\r\n             steroid doses > 10 mg daily prednisone equivalent are permitted in the absence of\r\n             active autoimmune disease.\r\n\r\n         12. Patients with interstitial lung disease that is symptomatic or may interfere with the\r\n             detection or management of suspected drug-related pulmonary toxicity.\r\n\r\n         13. Patients unable to swallow orally administered medication and patients with\r\n             gastrointestinal disorders likely in to interfere with absorption of the trial\r\n             medication.\r\n\r\n         14. Females who are pregnant or breast-feeding.\r\n\r\n         15. Active infection requiring systemic treatment.\r\n\r\n         16. Current or previous regular use of aspirin (at any dose) or current use of another\r\n             NSAID for any indication (see appendix IV for list of medications not permitted in the\r\n             trial). Regular aspirin use is defined as taking aspirin more than twice in any given\r\n             week for more than 4 consecutive weeks. Current NSAID use is defined as taking any\r\n             NSAID for more than a week in the preceding month. If investigators feel that this\r\n             definition may unfairly exclude a participant, this can be discussed with the CI/MCTU\r\n             and a case by case decision will be made.\r\n\r\n         17. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs\r\n             chemically related to the study treatments.\r\n      ","sponsor":"The Christie NHS Foundation Trust","sponsor_type":"Other","conditions":"Breast Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Aspirin","description":"300mg tablets"},{"intervention_type":"Drug","name":"Drug: Lansoprazole","description":"30mg"},{"intervention_type":"Drug","name":"Drug: Avelumab","description":"(Arm A) Avelumab + Proto Pump Inhibitor (PPI)"}],"outcomes":[{"outcome_type":"primary","measure":"1. Mean combined gene expression of COX-2 tumour-promoting genes","time_frame":"7 weeks","description":"1. Mean combined gene expression of COX-2 tumour-promoting genes, in samples taken post treatment"},{"outcome_type":"secondary","measure":"Post treatment tumour infiltrating lymphocytes (TIL)","time_frame":"7 weeks","description":"Post treatment tumour infiltrating lymphocytes (TIL) assessed by IHC using standardised methodology (Salgado et al., 2015)"},{"outcome_type":"secondary","measure":"Mean combined gene expression of the cancer-inhibitory elements of the COX-2 inflammatory signature","time_frame":"7 weeks","description":"Mean combined gene expression of the cancer-inhibitory elements of the COX-2 inflammatory signature, in samples taken post treatment"},{"outcome_type":"secondary","measure":"The post treatment COX-2 inflammatory signature","time_frame":"7 weeks","description":"The post treatment COX-2 inflammatory signature"},{"outcome_type":"secondary","measure":"Safety and tolerability assessed by grade 3-4 AEs and SAEs","time_frame":"7 weeks","description":"Safety and tolerability assessed by grade 3-4 AEs and SAEs. In addition, grade 2 renal toxicity AEs (creatinine rise) and grade 2 gastrointestinal toxicity AEs (duodenal perforation, dyspepsia, oesophageal haemorrhage, dysphagia, oesophageal pain, oesophageal perforation, oesophagitis)"}]}
{"nct_id":"NCT04933513","start_date":"2021-09-30","enrollment":22,"brief_title":"Development and Validation of a Scale Measuring Preoperative Expectations in Parkinson's Disease","official_title":"Development and Validation of a French Scale Measuring Preoperative Expectations of Parkinson's Disease Patients Candidate to Deep Brain Stimulation : the DBS-PS (Deep Brain Stimulation Perception Scale)","primary_completion_date":"2021-09-30","study_type":"Observational","rec_status":"Not yet recruiting","completion_date":"2021-09-30","last_update":"2021-08-18","description":"Subthalamic nucleus deep brain stimulation (STN-DBS) has become a choice treatment for fluctuating Parkinson's disease (PD) patients, inducing remarkable improvement in motor symptoms. However, as PD is a complex neuropsychiatric disease, it has been hypothesized that in some patients, non-motor features, i.e. dysfunctional expectations for the result of neurosurgery, could interfere with postoperative result of DBS, even in case of motor improvement. Recent literature highlights the necessity to take these preoperative expectations into account, but to our knowledge, no specific scale investigating these cognitions in this PD-specific condition is available. So, the investigators developped the DBS-PS, a self-scale constructed to measure preoperative expectations for DBS, with 11 questions and visuo-analogical responses (1 to 10), theorically divided in three domains investigating the expectations concerning symptoms of PD, postoperative social-life and leisures, and postoperative familial and marital sphere. The investigators would like to validate this new-developped scale in the preoperative subthalamic nucleus deep brain stimulation population through patients recruited in the Predistim study, whereas the investigators did not recruite sufficiently patients through the PsyParkinson study, the one in which the DBS-PS scale was developed. The DBS-PS constitutes an interesting basis for the consideration of these cognitive and affective factors in preoperative PD patients.","other_id":"2020PI179","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"- Parkinson's disease patients selected for STN DBS and participating to the Predistim\r\n        study","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Parkinson's disease patients included in the Predistim study and having completed the\r\n             DBS-PS scale during the preoperative phase\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Parkinson's disease patients not included in the Predistim study or not having\r\n             completed the DBS-PS scale during the preoperative phase\r\n      ","sponsor":"Central Hospital, Nancy, France","sponsor_type":"Other","conditions":"Parkinson's Disease","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: pre DBS patients responding to the DBS-PS scale","description":"we propose to parkinson's disease patients selected for subthalamic deep brain stimulation to complete the DBS-PS scale preoperatively"}],"outcomes":[{"outcome_type":"primary","measure":"Validation of the Deep-brain stimulation - perception scale (DBS-PS scale)","time_frame":"during the inclusion/baseline period of Predistim study","description":"Deep Brain Stimulation-Perception Scale completed by Parkinson's disease patients enrolled in the Predistim study; minimum scale score 0 - maximum scale score 50, for each sub-scores (3 dimensions) ; a higher score corresponding to higher expectations in the dimension, and a lower score coresponding to lower expectations in the dimension"}]}
{"nct_id":"NCT05039073","start_date":"2021-09-30","phase":"Phase 2","enrollment":46,"brief_title":"Brentuximab Vedotin and Nivolumab for the Treatment of Relapsed/Refractory Classic Hodgkin Lymphoma Previously Treated With Brentuximab Vedotin or Checkpoint Inhibitors","official_title":"A Phase 2 Study of Brentuximab Vedotin Plus Nivolumab in Patients With Relapsed/Refractory Hodgkin Lymphoma Previously Treated With Brentuximab or Checkpoint Inhibitors","primary_completion_date":"2026-11-30","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2027-11-30","last_update":"2021-09-09","description":"This phase II trial studies the effect of brentuximab vedotin and nivolumab in treating patients with classic Hodgkin lymphoma that has come back (relapsed) or does not respond to treatment (refractory) that have been previously treated with brentuximab vedotin or checkpoint inhibitors. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to CD30 positive cancer cells in a targeted way and delivers vedotin to kill them. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving brentuximab vedotin and nivolumab in combination may be an effective treatment in patients with relapsed or refractory classic Hodgkin lymphoma previously treated with brentuximab vedotin or checkpoint inhibitors.","other_id":"STUDY00002348","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":12,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically confirmed classical Hodgkin lymphoma\r\n\r\n          -  Patients must be 12 years of age or older\r\n\r\n          -  Patients must have received at least 1-2 prior multi-agent chemotherapy or\r\n             immunotherapy regimens will be divided into two cohorts based on the following\r\n             clinical scenarios:\r\n\r\n               -  Patients enrolled to cohort A must have received only ONE prior\r\n                  brentuximab-containing regimen with NO prior checkpoint inhibitors. Patients\r\n                  enrolled to cohort A must have received brentuximab as part of their first-line\r\n                  treatment regimen.\r\n\r\n               -  Patients enrolled to cohort B must have received only ONE prior immune checkpoint\r\n                  inhibitor- (i.e. nivolumab or pembrolizumab) containing regimen and NO prior\r\n                  brentuximab. Patients in cohort B may have received an immune checkpoint\r\n                  inhibitor during either their first- or second-line treatment regimen.\r\n\r\n               -  If radiation is used as part of the planned front-line treatment regimen (i.e.,\r\n                  brentuximab vedotin-doxorubicin-vinblastine-dacarbazine [BV-AVD] + radiation\r\n                  therapy [RT] for bulky stage II disease), this will count as only 1 prior\r\n                  therapy. Additionally, radiation as consolidation after a second-line multi-agent\r\n                  chemotherapy regimen is permitted and will not be counted as a third regimen\r\n\r\n          -  No prior autologous or allogeneic transplant\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 2 for patients > 18\r\n             years old, or Lansky performance status of >= 50 for patients ages 12-18 years\r\n\r\n          -  Enrolling patients must have measurable disease defined as a tumor or nodal mass > 1.5\r\n             cm in at least one dimension\r\n\r\n          -  Resolution of all prior toxicities, including peripheral neuropathy, to a =< grade 1\r\n\r\n          -  Absolute neutrophil count (ANC) >= 750, unless disease related (within 28 days of\r\n             cycle 1 day 1)\r\n\r\n          -  Platelets >= 50,000, unless disease related (within 28 days of cycle 1 day 1)\r\n\r\n          -  Creatinine =< upper limit of normal (ULN) (within 28 days of cycle 1 day 1)\r\n\r\n          -  Aspartate aminotransferase/alanine aminotransferase (AST/ALT) =< 3 x ULN (within 28\r\n             days of cycle 1 day 1)\r\n\r\n          -  Bilirubin =< 2 mg/dL (within 28 days of cycle 1 day 1)\r\n\r\n          -  Patients with human immunodeficiency virus (HIV) infection are eligible. Patients with\r\n             HIV infection must meet the following criteria: No evidence of co-infection with\r\n             hepatitis B or C; CD4+ count >= 400/mm; no evidence of resistant strains of HIV; on\r\n             anti-HIV therapy with an HIV viral load < 50 copies HIV ribonucleic acid (RNA)/mL.\r\n             Patients with HIV must have ongoing follow-up with an infectious disease specialist\r\n             and must have been evaluated within 90 days of cycle 1 day 1.\r\n\r\n          -  Females of child-bearing potential (FCBP) must have a negative urine pregnancy test\r\n             prior to starting therapy. If the test is positive, pregnancy must be ruled out\r\n\r\n          -  FCBP and men treated or enrolled on this protocol must agree to use adequate\r\n             contraception (hormonal or barrier method of birth control; abstinence) prior to study\r\n             entry for the duration of study participation, and 6 months after completion of\r\n             brentuximab and/or nivolumab administration. Should a woman become pregnant or suspect\r\n             she is pregnant while she or her partner is participating in this study, she should\r\n             inform her treating physician immediately.\r\n\r\n               -  A female of childbearing potential (FCBP) is a post-menarcheal woman who: 1) has\r\n                  not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been\r\n                  naturally postmenopausal for at least 24 consecutive months (i.e., has had menses\r\n                  at any time in the preceding 24 consecutive months\r\n\r\n          -  Completion of all previous therapy (including surgery, radiotherapy, chemotherapy,\r\n             immunotherapy, or investigational therapy) for the treatment of cancer >= 2 weeks\r\n             before the start of study therapy\r\n\r\n          -  Patients with known history or current symptoms of cardiac disease, or history of\r\n             treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac\r\n             function using the New York Heart Association Functional Classification. To be\r\n             eligible for this trial, patients should be class 2B or better\r\n\r\n          -  Willingness and ability of the subject to comply with scheduled visits, drug\r\n             administration plan, protocol-specified laboratory tests, other study procedures, and\r\n             study restrictions\r\n\r\n          -  Evidence of a personally signed informed consent by patients >= 18 year old (YO) or\r\n             parent or legally authorized representative (LAR) for patients 12-17 YO indicating\r\n             that the subject is aware of the neoplastic nature of the disease and has been\r\n             informed of the procedures to be followed, the experimental nature of the therapy,\r\n             alternatives, potential risks and discomforts, potential benefits, and other pertinent\r\n             aspects of study participation. Patients 12-17 will also be required to give assent to\r\n             the process per institutional guidelines\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior malignancy, except for adequately treated basal cell or squamous cell skin\r\n             cancer, in situ cervical cancer, or other cancer from which the subject has been\r\n             disease free for >= 2 years or which will not limit survival to < 2 years\r\n\r\n          -  Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering\r\n             the study or those who have not recovered from adverse events to =< grade 1\r\n\r\n          -  Active autoimmune disease or history of autoimmune disease such as hepatitis,\r\n             hypophysitis, nephritis, interstitial lung disease, and colitis\r\n\r\n          -  Active central nervous system (CNS) involvement with lymphoma\r\n\r\n          -  Patients with hepatitis B (positive hepatitis B virus surface antigen [HBsAg] or\r\n             hepatitis B virus core antibody [HBcAb]) and those with positive hepatitis C virus\r\n             (HCV) antibodies are not permitted to enroll\r\n\r\n          -  No active infection, or other active illness including, but not limited to, ongoing or\r\n             active infection, symptomatic congestive heart failure, unstable angina pectoris,\r\n             cardiac arrhythmia, or psychiatric illness/social situations that would limit\r\n             compliance with study requirements\r\n      ","sponsor":"Emory University","sponsor_type":"Other","conditions":"Recurrent Classic Hodgkin Lymphoma|Refractory Classic Hodgkin Lymphoma","interventions":[{"intervention_type":"Drug","name":"Drug: Brentuximab Vedotin","description":"Given IV"},{"intervention_type":"Procedure","name":"Procedure: Hematopoietic Cell Transplantation","description":"Undergo HSCT"},{"intervention_type":"Biological","name":"Biological: Nivolumab","description":"Given IV"},{"intervention_type":"Other","name":"Other: Quality-of-Life Assessment","description":"Ancillary studies"},{"intervention_type":"Other","name":"Other: Questionnaire Administration","description":"Ancillary studies"}],"outcomes":[{"outcome_type":"primary","measure":"Overall response rate (ORR)","time_frame":"Up to 16 cycles (each cycle is 21 days)","description":"Will be calculated and a 95% confidence interval will be estimated using the Clopper-Pearson method. Assessed per Lugano 2014 Criteria at any time point while on study therapy. Will be analyzed independently for each cohort (A and B)."},{"outcome_type":"secondary","measure":"Complete response rate (CRR)","time_frame":"Up to 16 cycles (each cycle is 21 days)","description":"Will be calculated and a 95% confidence interval will be estimated using the Clopper-Pearson method. Will be determined per Lugano 2014 criteria at any disease assessment time point while the patient is receiving study therapy."},{"outcome_type":"secondary","measure":"Progression-free survival (PFS)","time_frame":"From time of study enrollment until first documentation of progressive disease or death from any cause, assessed up to 5 years","description":"Will be described using the Kaplan-Meier methodology. 95% confidence intervals for 1-year and 2-year PFS will be calculated, with standard errors estimated using the Greenwood formula. Patients alive without disease progression will be censored at last follow-up date."},{"outcome_type":"secondary","measure":"Overall survival (OS)","time_frame":"From time of study enrollment until death from any cause, assessed up to 5 years","description":"Will be described using the Kaplan-Meier methodology. 95% confidence intervals for 1-year and 2-year OS will be calculated, with standard errors estimated using the Greenwood formula. Patients who have not died will be censored at last follow-up date."},{"outcome_type":"secondary","measure":"Incidence of adverse events","time_frame":"Up to 5 years","description":"According to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0)."},{"outcome_type":"secondary","measure":"Incidence of symptomatic toxicity","time_frame":"Up to 5 years","description":"Evaluated by Patient Reported Outcomes (PRO)-CTCAE or Pediatric PRO-CTCAE."}]}
{"nct_id":"NCT04753359","start_date":"2021-09-30","phase":"N/A","enrollment":232,"brief_title":"Mediterranean Diet and Weight Loss: Targeting the Bile Acid/Gut Microbiome Axis to Reduce Colorectal Cancer","official_title":"Mediterranean Diet and Weight Loss: Targeting the Bile Acid/Gut Microbiome Axis to Reduce Colorectal Cancer","primary_completion_date":"2024-03-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2025-03-31","last_update":"2021-04-27","description":"A Mediterranean Diet (MedDiet), a largely plant-based dietary pattern, is relevant to CRC prevention and microbial production of anti-cancer metabolites in observational studies. A MedDiet can shift BA metabolism as shown in primates and when combined with calorie restriction, shows superior adherence and weight control in humans, given its palatability. To date, no studies have tested in an RCT the effects of a MedDiet alone (MedA), WL through lifestyle intervention (WL-A) or a calorie-restricted MedDiet for WL (WL-Med) on the BA-gut microbiome axis and its relevance to CRC prevention among AAs. A multidisciplinary team combining expertise in psychology, nutrition, microbiology, molecular cell biology, computational biology, medicine and biostatistics, propose to conduct a four-arm RCT in which 200 obese AAs, 45-75 years old complete one of the following 8-month interventions: Med-A, weight stable; WL-A, calorie restriction with no diet pattern change; WLMed; or Control. The investigators will use samples and data collected at baseline, mid-study (month-4) and post-intervention to compare the effects of the interventions on 1) Concentration and composition of circulating and fecal BAs; 2) Gut microbiota and metabolic function; and 3) Gene expression profiles of exfoliated intestinal epithelial cells.","other_id":"2020-1342","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","intervention_model_description":"This study is a four-arm RCT designed to test the effect of a weight-stable MedDiet alone (Med-A) lifestyle intervention, calorie restriction for WL with no diet composition change (WL-A) intervention, a MedDiet WL lifestyle intervention (WL-Med) compared to Control on BA metabolism, the gut microbiome, and gene expression in exfoliated intestinal epithelial cells. The study includes 1) screening potential subjects; 2) baseline assessment of diet, lifestyle behaviors (e.g., physical activity), anthropometrics, and blood and fecal sampling; 3) a four-arm RCT; and 4) mid-(month 4) and post-intervention (month 8) assessments.","sampling_method":"","gender":"All","minimum_age":45,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Men and women 45-75 years of age\r\n\r\n          -  Self-identify as AA\r\n\r\n          -  BMI 30-50 kg/m2\r\n\r\n          -  Up to date with CRC screening (confirmed via EMR) or if not up to date, negative fecal\r\n             immunochemical test (FIT) (UI Health can offer FIT to all eligible patients, and\r\n             navigate those with positive results to direct access colonoscopy)\r\n\r\n          -  Willingness to participate in all procedures including maintaining weight/current\r\n             physical activity if randomized to Med-A/Control\r\n\r\n          -  Willingness to provide informed consent\r\n\r\n          -  Willingness to be randomized\r\n\r\n          -  Understands English\r\n\r\n          -  Has access to a phone\r\n\r\n          -  Plans to reside in Chicago for the next 8-10 months.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Renal disease\r\n\r\n          -  autoimmune disorders\r\n\r\n          -  immunodeficiency\r\n\r\n          -  malabsorptive disorders\r\n\r\n          -  significant gastrointestinal and/or hepatic diseases\r\n\r\n          -  severe ischemic heart disease\r\n\r\n          -  severe pulmonary disease\r\n\r\n          -  history of bariatric surgery\r\n\r\n          -  alcohol abuse (> 50 grams/day)\r\n\r\n          -  illicit drug abuse (other than marijuana based on self-report)\r\n\r\n          -  combustible tobacco use\r\n\r\n          -  uncontrolled diabetes based on HbA1c > 9.0%\r\n\r\n          -  eating disorder\r\n\r\n          -  cancer treatment within the past 12 months\r\n\r\n          -  positive FIT at the time of screening (subject can participate in a later wave pending\r\n             results of direct access colonoscopy)\r\n\r\n          -  history of CRC\r\n\r\n          -  genetic predisposition to CRC (e.g., Lynch syndrome)\r\n\r\n          -  gait disorder\r\n\r\n          -  weight > 450 lbs. (weight limitation of the DXA scanner)\r\n\r\n          -  currently adhering to a MedDiet based on a diet screener\r\n\r\n          -  self-reported WL > 3% in the past 12 months\r\n\r\n          -  currently on a WL diet or actively involved in a formal WL program (e.g., Weight\r\n             Watchers)\r\n\r\n          -  food allergies that would interfere with adopting a MedDiet\r\n\r\n          -  antibiotic use in the past 3 months\r\n\r\n          -  night-shift work\r\n\r\n          -  regular use (i.e.,  3 times per week) of prebiotics/probiotics/synbiotics, dietary\r\n             fiber supplements, or laxatives,\r\n      ","sponsor":"University of Illinois at Chicago","sponsor_type":"Other","conditions":"Colorectal Cancer|Diet Habit","interventions":[{"intervention_type":"Other","name":"Other: Med","description":"Mediterranean diet"},{"intervention_type":"Other","name":"Other: WL","description":"Measuring change in weight"}],"outcomes":[{"outcome_type":"primary","measure":"Circulating and fecal bile acids","time_frame":"baseline","description":"Absolute measurement of BAs in stool and serum obtained at baseline will be performed under the direction of Co-I Ridlon. Samples will be extracted, and supernatants will be dried and resuspended for LC/MS analysis following validated and published methods. We will quantify all major primary and secondary BAs (e.g., DCA) and glycine and taurine conjugates and their ratios, as well as total BAs and total unconjugated BAs. Authentic reference BAs will be purchased from Sigma-Aldrich and Steraloids. Blind duplicate samples will be used to assess inter- and intra-batch precision."},{"outcome_type":"primary","measure":"Circulating and fecal bile acids","time_frame":"4 month","description":"Absolute measurement of BAs in stool and serum obtained at mid-study (4 month follow up) will be performed under the direction of Co-I Ridlon. Samples will be extracted, and supernatants will be dried and resuspended for LC/MS analysis following validated and published methods. We will quantify all major primary and secondary BAs (e.g., DCA) and glycine and taurine conjugates and their ratios, as well as total BAs and total unconjugated BAs. Authentic reference BAs will be purchased from Sigma-Aldrich and Steraloids. Blind duplicate samples will be used to assess inter- and intra-batch precision."},{"outcome_type":"primary","measure":"Circulating and fecal bile acids","time_frame":"8 month","description":"Absolute measurement of BAs in stool and serum obtained at post-intervention (8 month follow up) will be performed under the direction of Co-I Ridlon. Samples will be extracted, and supernatants will be dried and resuspended for LC/MS analysis following validated and published methods. We will quantify all major primary and secondary BAs (e.g., DCA) and glycine and taurine conjugates and their ratios, as well as total BAs and total unconjugated BAs. Authentic reference BAs will be purchased from Sigma-Aldrich and Steraloids. Blind duplicate samples will be used to assess inter- and intra-batch precision."},{"outcome_type":"primary","measure":"Gut microbiota for metabolic function","time_frame":"baseline","description":"The UIC Genomics core will PCR amplify genomic DNA with primers CS1_515F and CS2_806R (modified from the set used by the Earth Microbiome Project) targeting the V4 region of microbial small subunit ribosomal RNA genes. Amplicons will be generated using a two-stage PCR protocol. The V4 region of the 16S rRNA gene will be sequenced with the Illumina MiSeq platform to generate 2x250 bp paired end reads per sample. Environmental controls will be included in the sequences to distinguish from any contaminants in reagents or the lab environment."},{"outcome_type":"primary","measure":"Gut microbiota for metabolic function","time_frame":"4 month","description":"The UIC Genomics core will PCR amplify genomic DNA with primers CS1_515F and CS2_806R (modified from the set used by the Earth Microbiome Project) targeting the V4 region of microbial small subunit ribosomal RNA genes. Amplicons will be generated using a two-stage PCR protocol. The V4 region of the 16S rRNA gene will be sequenced with the Illumina MiSeq platform to generate 2x250 bp paired end reads per sample. Environmental controls will be included in the sequences to distinguish from any contaminants in reagents or the lab environment."},{"outcome_type":"primary","measure":"Gut microbiota for metabolic function","time_frame":"8 month","description":"The UIC Genomics core will PCR amplify genomic DNA with primers CS1_515F and CS2_806R (modified from the set used by the Earth Microbiome Project) targeting the V4 region of microbial small subunit ribosomal RNA genes. Amplicons will be generated using a two-stage PCR protocol. The V4 region of the 16S rRNA gene will be sequenced with the Illumina MiSeq platform to generate 2x250 bp paired end reads per sample. Environmental controls will be included in the sequences to distinguish from any contaminants in reagents or the lab environment."},{"outcome_type":"primary","measure":"Gene expression","time_frame":"baseline","description":"From stool preserved in Ambion Denaturation Solution, eukaryotic polyA+ RNA will be isolated using the Active Motif mTRAP Maxi kit followed by DNA removal with DNAFree (Invitrogen). Libraries will be quantified using the Library Quantification kit (Kapa Biosystems), and sequencing will be performed on an Illumina HiSeq 2500 platform using standard Illumina protocols. RNA reads will be mapped with the STAR aligner using the default parameters to the Ensembl GRCh38 human reference. Reads will be examined for quality control using FastQC and quantified using HTSeq-count. Sequencing reads will be filtered to remove genes present in low abundance. For stool exfoliated cells, the RNA-seq gene count matrix is very sparse, with most entries corresponding to zero transcripts; thus, genes in stool will be removed if >33% of the samples contain only 0 or 1 read."},{"outcome_type":"primary","measure":"Gene expression","time_frame":"4 month","description":"From stool preserved in Ambion Denaturation Solution, eukaryotic polyA+ RNA will be isolated using the Active Motif mTRAP Maxi kit followed by DNA removal with DNAFree (Invitrogen). Libraries will be quantified using the Library Quantification kit (Kapa Biosystems), and sequencing will be performed on an Illumina HiSeq 2500 platform using standard Illumina protocols. RNA reads will be mapped with the STAR aligner using the default parameters to the Ensembl GRCh38 human reference. Reads will be examined for quality control using FastQC and quantified using HTSeq-count. Sequencing reads will be filtered to remove genes present in low abundance. For stool exfoliated cells, the RNA-seq gene count matrix is very sparse, with most entries corresponding to zero transcripts; thus, genes in stool will be removed if >33% of the samples contain only 0 or 1 read."},{"outcome_type":"primary","measure":"Gene expression","time_frame":"8 month","description":"From stool preserved in Ambion Denaturation Solution, eukaryotic polyA+ RNA will be isolated using the Active Motif mTRAP Maxi kit followed by DNA removal with DNAFree (Invitrogen). Libraries will be quantified using the Library Quantification kit (Kapa Biosystems), and sequencing will be performed on an Illumina HiSeq 2500 platform using standard Illumina protocols. RNA reads will be mapped with the STAR aligner using the default parameters to the Ensembl GRCh38 human reference. Reads will be examined for quality control using FastQC and quantified using HTSeq-count. Sequencing reads will be filtered to remove genes present in low abundance. For stool exfoliated cells, the RNA-seq gene count matrix is very sparse, with most entries corresponding to zero transcripts; thus, genes in stool will be removed if >33% of the samples contain only 0 or 1 read."}]}
{"nct_id":"NCT05000138","start_date":"2021-09-30","enrollment":134,"brief_title":"FDG Digital PET/CT as First Line Investigation for Giant Cell Arteritis","official_title":"FDG Digital PET/CT as First Line Investigation for Giant Cell Arteritis","primary_completion_date":"2022-12-30","study_type":"Observational","rec_status":"Not yet recruiting","completion_date":"2023-03-30","last_update":"2021-08-11","description":"Giant cell arteritis (GCA) causes inflammation of the arteries and can lead to serious complications such as blindness, necessitating rapid diagnosis and treatment. Although older technology non-digital PET/CT scans are routinely used for the diagnosis of GCA in large arteries, they have not been able to reliably detect inflammation of the small arteries responsible for blindness. Recent technological advances have enabled PET/CT imaging of millimetric disease in the body, and Quebec has been one of the first to deploy these new digital PET/CT scanners, which are now able to resolve small arteries. In the proposed research study, patients who are suspected by their doctors to have GCA will undergo temporal artery biopsy (the standard of care), an ultrasound of the temporal arteries, and digital PET/CT scan after injection of radioactive glucose. Digital PET/CT scans will be interpreted for the presence of abnormal uptake in the large and small arteries, as well as for the presence of other causes of the patient's symptoms. The diagnostic accuracy of PET/CT and ultrasound will be evaluated with respect to an expert panel diagnosis of giant cell arteritis and compared. Results will be adjusted for lack of a perfect reference test using advanced statistics. The goal will be to see if digital PET/CT can become a single, integrated test to diagnose this disease.","other_id":"MP-05-2021-2846","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":50,"population":"Patients with suspected GCA","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age  50 years, capable and willing to provide informed consent and can tolerate\r\n             PET/CT.\r\n\r\n          -  ESR  50 mm/h and/or CRP  10mg/L within 1 week of PET/CT referral.\r\n\r\n          -  New suspected giant cell arteritis according to at least one of the following\r\n             criteria:\r\n\r\n        Cranial GCA symptoms (new-onset localized headache, scalp or temporal artery tenderness,\r\n        ischemia-related vision loss, masseter pain on prolonged mastication) PMR symptoms:\r\n        shoulder and/or hip girdle pain associated with inflammatory stiffness.\r\n\r\n        Suspected large-vessel vasculitis based on angiography, MRA, or CTA.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Initiation of corticosteroid or immunosuppressive therapy >4 days before PET/CT.\r\n\r\n          -  Prior TAB or treated GCA with suspected relapse.\r\n\r\n          -  Non-fasting or hyperglycemia (>11.1 mmol/L) resulting in altered FDG biodistribution.\r\n      ","sponsor":"Jewish General Hospital","sponsor_type":"Other","conditions":"Giant Cell Arteritis|Vasculitis","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: FDG PET/CT","description":"Patients with suspected giant cell arteritis, of which FDG PET/CT is indicated for diagnosis of large vessel involvement, will have the small cranial arteries analyzed for involvement."}],"outcomes":[{"outcome_type":"primary","measure":"Diagnostic Performance","time_frame":"2 years","description":"of Digital PET/CT and DUS for the diagnosis of GCA"}]}
{"nct_id":"NCT04875975","start_date":"2021-09-30","phase":"Phase 2","enrollment":68,"brief_title":"A Study to Test the Efficacy, Safety, and Pharmacokinetics of Rozanolixizumab in Adult Study Participants With Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis","official_title":"A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Rozanolixizumab in Adult Study Participants With Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis","primary_completion_date":"2023-11-30","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2023-11-30","last_update":"2021-08-23","description":"The purpose of the study is to assess the efficacy of rozanolixizumab as measured by seizure freedom, onset of seizure freedom, change in cognitive function, use of rescue medication and to assess safety and tolerability.","other_id":"AIE001","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":89,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Study participant must be 18 to 89 years of age, at the time of signing the informed\r\n             consent\r\n\r\n          -  Study participant must be seropositive for leucine-rich glioma inactivated 1 (LGI1)\r\n             antibody measured by LGI1 serum autoantibody cell-binding assay\r\n\r\n          -  Study participant must have faciobrachial dystonic seizures (FBDS) and/or other\r\n             partial [focal] seizures with or without secondary generalization (2 seizures/week)\r\n             during the Screening Period, or have experienced such seizures that stopped as a\r\n             result of intravenous methylprednisolone (IVMP) initiation\r\n\r\n          -  Study participant is currently considered for treatment with IVMP by the investigator\r\n             or has initiated IVMP treatment at a dose of 500 to 1000 mg/day within 14 days prior\r\n             to randomization. If the study participant has initiated a steroid taper, the study\r\n             participant cannot be receiving an oral steroid dose lower than 60 mg/day when\r\n             randomized\r\n\r\n          -  Study participant with onset of disease between 0 to 12 months prior to Screening\r\n\r\n          -  Study participant weighs at least 35 kg (for males and females) at Screening\r\n\r\n          -  A male participant must agree to use contraception during the treatment period and for\r\n             at least 90 days after the final dose of study treatment and refrain from donating\r\n             sperm during this period\r\n\r\n          -  A female participant is eligible to participate if she is not pregnant, not\r\n             breastfeeding, and at least one of the following conditions applies:\r\n\r\n             i) Not a woman of childbearing potential (WOCBP) OR ii) A WOCBP who agrees to follow\r\n             the contraceptive guidance during the treatment period and for at least 90 days after\r\n             the final dose of study treatment\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Study participant has a known hypersensitivity to any components of the study\r\n             medication or any other anti-neonatal Fc receptor (FcRn) medications. This includes a\r\n             known history of hyperprolinemia, since L-proline is a constituent of the\r\n             rozanolixizumab formulation\r\n\r\n          -  Study participant has a confirmed prior diagnosis of epilepsy that is unrelated to\r\n             LGI1 autoimmune encephalitis (AIE)\r\n\r\n          -  Study participant has active neoplastic disease or history of neoplastic disease\r\n             within 5 years of study entry (except for basal or squamous cell carcinoma of the skin\r\n             or carcinoma in situ of the uterine cervix which has been definitively treated with\r\n             standard of care approaches)\r\n\r\n          -  Study participant has 12-lead electrocardiogram (ECG) with findings considered\r\n             clinically significant upon medical review\r\n\r\n          -  Study participant has current unstable liver or biliary disease, per investigator\r\n             assessment, defined by the presence of ascites, encephalopathy, coagulopathy,\r\n             hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis\r\n\r\n          -  Study participant has positive tuberculosis (TB) test at the Screening Visit\r\n\r\n          -  Study participant has any of the following active gastrointestinal (GI) disorders:\r\n             inflammatory bowel disease, GI ulceration, or diverticulitis\r\n\r\n          -  Study participant has a history of solid organ transplant or hematopoietic stem cell\r\n             transplant\r\n\r\n          -  Study participant has undergone a splenectomy\r\n\r\n          -  Study participant has a current or medical history of primary immune deficiency\r\n\r\n          -  Study participant has been treated with prohibited immunosuppressants, biologics, and\r\n             other therapies\r\n\r\n          -  Study participant has received a live vaccination within 8 weeks prior to the Baseline\r\n             Visit; or intends to have a live vaccination during the course of the study or within\r\n             8 weeks following the final dose of investigational medicinal product (IMP)\r\n\r\n          -  Study participant has previously received rozanolixizumab drug product\r\n\r\n          -  Alanine transaminase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase\r\n             (ALP) are >2x upper limit of normal (ULN)\r\n\r\n          -  Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is\r\n             fractionated and direct bilirubin <35 %)\r\n\r\n          -  Current or chronic history of liver disease, or known hepatic or biliary abnormalities\r\n             (with the exception of Gilbert's syndrome or asymptomatic gallstones)\r\n\r\n          -  For randomized study participants with a Baseline result >ULN for ALT, AST, ALP, or\r\n             total bilirubin but <1.5xULN, a Baseline diagnosis and/or the cause of any clinically\r\n             meaningful elevation will have to be understood and recorded in the electronic case\r\n             report form (eCRF)\r\n\r\n          -  If study participant has >ULN for ALT, AST, or ALP that does not meet the exclusion\r\n             limit at Screening, the tests should be repeated, if possible, prior to dosing to\r\n             ensure there was no further ongoing clinically relevant increase. In case of a\r\n             clinically relevant increase, inclusion of the study participants will have to be\r\n             discussed with the medical monitor\r\n\r\n          -  Tests that result in ALT, AST, or ALP up to 25 % above the exclusion limit (>2xULN)\r\n             will have to be repeated once for confirmation. This includes rescreening\r\n\r\n          -  Study participant has an IgG level 5.5 g/L at the Screening Visit\r\n\r\n          -  Study participant has absolute neutrophil count <1500 cells/mm^3 at the Screening\r\n             Visit\r\n\r\n          -  Participant has QT interval corrected for heart rate using Fridericia's formula (QTcF)\r\n             >450 msec (for male participants) or QTcF >470 msec (for female participants) or QTcF\r\n             >480 msec in participants with bundle branch block\r\n      ","sponsor":"UCB Biopharma SRL","sponsor_type":"Industry","conditions":"Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis","interventions":[{"intervention_type":"Drug","name":"Drug: Rozanolixizumab","description":"Pharmaceutical form: Solution for infusion\r\nRoute of administration: Subcutaneous use\r\nSubjects will receive rozanolixizumab in a pre-specified sequence during the Treatment Period."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Pharmaceutical form: Solution for infusion\r\nRoute of administration: Subcutaneous use\r\nSubjects will receive placebo in a pre-specified sequence during the Treatment Period."}],"outcomes":[{"outcome_type":"primary","measure":"Proportion of seizure free study participants at the end of the Treatment Period","time_frame":"From Baseline until the end of the Treatment Period (Week 25)","description":"Seizure freedom is defined by 28 consecutive days of no seizures maintained until the end of the Treatment Period"},{"outcome_type":"secondary","measure":"Change from Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) total scale index score at the end of the Treatment Period","time_frame":"From Baseline until the end of the Treatment Period (Week 25)","description":"The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) consists of 12 subtests that contribute to 5 age-based domain index scores (immediate memory, visuospatial, language, attention, delayed memory) that are aggregated for a total scale index score. Higher scores reflect better neurocognitive performance."},{"outcome_type":"secondary","measure":"Proportion of participants who required rescue medication due to an absence or loss of clinical benefit during the Treatment Period","time_frame":"From Baseline until the end of the Treatment Period (Week 25)","description":"Study participants who require rescue medication due to an absence or loss of clinical benefit will discontinue blinded treatment, and complete the assessments for the Early Discontinuation Visit."},{"outcome_type":"secondary","measure":"Time to first occurrence of seizure freedom during the Treatment Period","time_frame":"From Baseline until the end of the Treatment Period (Week 25)","description":"The time to first occurrence of seizure freedom (TTFSF) is defined by the number of days after randomization to the first day of the first 28 consecutive days without seizures during the Treatment Period"},{"outcome_type":"secondary","measure":"Incidence of Treatment-Emergent Adverse Events (TEAEs)","time_frame":"From Baseline until the End of Study Visit (Week 32)","description":"An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product."}]}
{"nct_id":"NCT04909879","start_date":"2021-09-30","phase":"Phase 2","enrollment":100,"brief_title":"Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Non-COVID-19 Acute Respiratory Distress Syndrome","official_title":"Treatment of Non-COVID-19 Acute Respiratory Distress Syndrome: A Phase 2 Study of the Efficacy and Safety of Intravenous Allogeneic Adipose-Derived Mesenchymal Stem Cells","primary_completion_date":"2022-02-28","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2022-04-30","last_update":"2021-06-07","description":"This is a Phase 2 randomized study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care treatments for subjects hospitalized subjects with acute respiratory distress syndrome not related to COVID-19 infection.","other_id":"MSC-ARDS-201","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Negative for SARS-CoV-2 infection as determined by an approved polymerase chain\r\n             reaction (PCR) or an approved antigen test of any specimen\r\n\r\n          -  Hospitalized with non-COVID-19-induced ARDS (any severity) with a PaO2/FiO2 (PF ratio)\r\n              300\r\n\r\n          -  Requires oxygen supplementation at Screening\r\n\r\n          -  Willing to follow contraception guidelines\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Current standard of care treatments for ARDS appear to be working and the subject is\r\n             clinically improving\r\n\r\n          -  A previous stem cell infusion unrelated to this trial\r\n\r\n          -  Pregnant or breast feeding or planning for either during the study\r\n\r\n          -  Suspected uncontrolled active bacterial, fungal, viral, or other infection\r\n\r\n          -  History of a splenectomy, lung transplant or lung lobectomy\r\n\r\n          -  Concurrent participation in another clinical trial involving therapeutic interventions\r\n             (observational study participation is acceptable)\r\n\r\n          -  Expected survival or time to withdrawal of life-sustaining treatments expected to be <\r\n             7 days\r\n      ","sponsor":"Sorrento Therapeutics, Inc.","sponsor_type":"Industry","conditions":"Acute Respiratory Distress Syndrome|Ards","interventions":[{"intervention_type":"Biological","name":"Biological: COVI-MSC","description":"COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Excipient solution"}],"outcomes":[{"outcome_type":"primary","measure":"All-cause mortality rate at Day 28","time_frame":"Baseline to Day 28","description":"All-cause mortality rate at Day 28"},{"outcome_type":"secondary","measure":"All-cause mortality rate at Days 60 and 90","time_frame":"Baseline to Day 60 and Day 90","description":"All-cause mortality rate at Days 60 and 90"},{"outcome_type":"secondary","measure":"Number of ventilator-free days through Day 28","time_frame":"Baseline through Day 28","description":"Number of ventilator-free days through Day 28"},{"outcome_type":"secondary","measure":"Number of ICU days through Day 28","time_frame":"Baseline through Day 28","description":"Number of ICU days through Day 28"},{"outcome_type":"secondary","measure":"Clinical status at Day 28","time_frame":"Baseline to Day 28","description":"Clinical status as assessed using the Ordinal Scale for Clinical Improvement (0-8 scale, where lower score means better outcome)"},{"outcome_type":"secondary","measure":"Change in oxygenation","time_frame":"Baseline to Day 2, Day 4, Day 6, Day 14, Day 28","description":"Change in oxygenation at Days 2, 4, 6, 14, and 28 as measured using PaO2:FiO2 ratio."}]}
{"nct_id":"NCT04961229","start_date":"2021-09-30","phase":"Phase 4","enrollment":450,"brief_title":"Booster Dose of COVID-19 Vaccine for Kidney Transplant Recipients Without Adequate Humoral Response","official_title":"Booster Dose of mRNA SARS-CoV-2 Vaccine for Kidney Transplant Recipients Without Adequate Humoral Response With or Without Immunosuppression Reduction - Protocol for a Randomised Controlled Trial (BECAME Study)","primary_completion_date":"2022-02-28","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2022-07-31","last_update":"2021-08-17","description":"Introduction: Inadequate antibody response to mRNA SARS-CoV-2 vaccination has been described among kidney transplant recipients. Immunosuppression level and specifically, use of antimetabolite in the maintenance immunosuppressive regimen, are associated with inadequate response. In light of the severe consequences of COVID-19 in solid organ transplant recipients, we believe it is justified to examine new vaccination strategies in these patients. Methods and analysis: BECAME is a single center, open label, investigator-initiated randomised controlled, superiority trial, aiming to compare immunosuppression reduction combined with a third BNT162b2 vaccine dose versus third dose alone. The primary outcome will be seropositivity rate against SARS-CoV-2. A sample size of 154 patients was calculated for the seropositivity endpoint assuming 25% seropositivity in the control group and 50% in the intervention group. A sample of participant per arm will be also teste for T-cell response. We also plan to perform a prospective observational study, evaluating seropositivity among ~500 kidney transplant recipients consenting to receive a third vaccine dose, who are not eligible for the randomised controlled trial. Ethics and dissemination: The trial is approved by local ethics committee of Rabin medical center (RMC-0192- 21). Results of this trial will be published; trial data will be available. Protocol amendments will be submitted to the local ethics committee.","other_id":"0192-21-RMC","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  kidney transplant recipients that received two doses of BNT162b2 vaccine at least 3\r\n             weeks prior to enrollment, and were seronegative (IgG against the spike protein of\r\n             SARS-CoV-2 below 50 AU/ml) at least two weeks after the second vaccine dose\r\n\r\n        Additional inclusion criteria for the RCT:\r\n\r\n          -  Recipients treated by three anti-rejection medications including: prednisone,\r\n             tacrolimus, mycophenolate mofetil or mycophenolic acid.\r\n\r\n          -  Tacrolimus trough blood levels 5-10 nGr/ml (lower or higher doses will have to be\r\n             adjusted before re-considering for inclusion)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Past infection with SARS-CoV-2\r\n\r\n          -  Pregnancy\r\n\r\n          -  Age below 18 years\r\n\r\n          -  Active infection\r\n\r\n        Additional exclusion criteria for RCT only:\r\n\r\n        - Recipients at a high risk for acute or chronic humoral rejection including:\r\n\r\n          -  Recipients with positive panel-reactive antibody (PRA) (any positive value) at any\r\n             time before or after transplantation\r\n\r\n          -  Recipients that had an acute rejection in the last year\r\n\r\n          -  Recipients less than 6 months after transplantation\r\n\r\n          -  Recipients that are considered at high risk for rejection according to the primary\r\n             care nephrologist\r\n\r\n          -  Recipients taking less than 3 anti-rejection medications\r\n\r\n          -  Recipients currently treated with mTOR inhibitors (everolimus, sirolimus) and/or\r\n             azathioprine\r\n\r\n          -  Recipients treated with plasmapheresis in the previous 3 months\r\n\r\n          -  Recipients treated with eculizumab in the last year\r\n\r\n          -  Recipient treated with IVIG in the previous 3 months\r\n\r\n          -  Recipient treated with rituximab in the previous 6 months\r\n      ","sponsor":"dafna yahav","sponsor_type":"Other","conditions":"COVID-19 Acute Respiratory Distress Syndrome|Immunosuppression","interventions":[{"intervention_type":"Biological","name":"Biological: The Pfizer mRNA-based BNT162b2 vaccine","description":"participants who gave informed consent to participate in either the prospective non-randomised study or RCT will receive a single vaccine dose.\r\nIn addition, participants in the RCT will be randomised into two groups:\r\nThird booster dose of BNT162b2 (one standard dose) with no change in immunosuppression protocol\r\nThird booster dose of BNT162b2 (one standard dose) with immunosuppression reduction according to protocol (mycophenolic temporary cessation 4 days before (5 half-lives) and one week (expected antibody response) after vaccination (to allow for antibody response)."}],"outcomes":[{"outcome_type":"primary","measure":"anti-spike protein titer above 50 AU/ml 2 weeks post vaccination","time_frame":"2 weeks post vaccination","description":"positive humoral response against SARS-CoV-2"},{"outcome_type":"secondary","measure":"anti-spike protein titer above 50 AU/ml 3-, 6-, and 12-months post vaccination","time_frame":"3-, 6-, and 12-months post vaccination","description":"positive humoral response against SARS-CoV-2"},{"outcome_type":"secondary","measure":"Log transformed titer of anti-spike protein weeks and 3, 6, and 12 months post vaccination","time_frame":"2 weeks and 3, 6, and 12 months post vaccination","description":"Log transformed titer of anti-spike protein"},{"outcome_type":"secondary","measure":"Adverse events to booster dose using CTCAE v4.0 criteria","time_frame":"2 weeks post vaccine","description":"Severity of adverse events will be assessed using CTCAE v4.0 criteria"},{"outcome_type":"secondary","measure":"Acute rejection of the allograft either documented by biopsy or clinically suspected, defined as increase in creatinine by 20% from baseline, without any other plausible explanation","time_frame":"2 weeks, 3,6, and 12 months post vaccination","description":"either documented by biopsy or clinically suspected, defined as increase in creatinine by 20% from baseline, without any other plausible explanation"},{"outcome_type":"secondary","measure":"positive PCR test to SARS-CoV-2 during the follow up period","time_frame":"until 12 months following vaccine","description":"positive PCR test to SARS-CoV-2 during the follow up period"},{"outcome_type":"secondary","measure":"Positive PCR tests to VZV, CMV","time_frame":"during the follow up period","description":"Other viral reactivation during the follow up period: VZV, CMV, tested according to clinical suspicion"},{"outcome_type":"secondary","measure":"Number of hospitalizations (numerical count)","time_frame":"until 12 months following vaccine","description":"Number of hospitalizations"}]}
{"nct_id":"NCT04925674","start_date":"2021-09-29","phase":"Phase 1","enrollment":60,"brief_title":"Study of HEC53856 in Patients With Subjects With End-Stage Renal Disease Receiving Dialysis.","official_title":"Phase Ic Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HEC53856 Capsules in Subjects With Renal Anemia on Dialysis","primary_completion_date":"2022-09-01","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2023-01-14","last_update":"2021-06-14","description":"To evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of HEC53856 capsules on anemia in subjects with chronic kidney disease on dialysis.","other_id":"HEC53856-RAD-103","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. The subject voluntarily participated in this clinical trial and signed an informed\r\n             consent form;\r\n\r\n          2. 18-70 years old, weight 45~90kg, including cut-off value;\r\n\r\n          3. Hemodialysis (Hemodialysis, HD): Patients with end-stage renal disease who are on\r\n             stable dialysis receive 3 times a week hemodialysis for at least 3 months before\r\n             screening, and can receive 3 times a week hemodialysis at regular intervals during the\r\n             test. The duration of the subject's hemodialysis treatment must be 3-4.5 hours\r\n             (including the cut-off value); Peritoneal dialysis: For patients with end-stage renal\r\n             disease on stable dialysis, the subject must receive peritoneal dialysis for at least\r\n             3 months before screening;\r\n\r\n          4. Subjects stop EPO 14 days or 5 half-lives (whichever is the longest) before taking the\r\n             test drug for the first time;\r\n\r\n          5. Subjects have stable dialysis methods and dialysis prescriptions, and are expected to\r\n             have no major treatment changes or no drastic changes in their condition during the\r\n             clinical trial period;\r\n\r\n          6. During the screening period, the hemoglobin value obtained by the two tests of Visit 1\r\n             and Visit 2 must be > or = 8.0 g/dL and <11.0 g/dL, and the difference between the two\r\n             must be < or = 1.5 g/dL.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Existence of past medical history or conditions that may cause anemia other than\r\n             nephropathy, including but not limited to blood system diseases, such as thalassemia,\r\n             aplastic anemia, hemolytic anemia, multiple myeloma, myelodysplastic syndrome, etc.;\r\n             Autoimmune diseases that may affect red blood cell production, such as systemic lupus\r\n             erythematosus, rheumatoid arthritis, etc.; Bleeding diseases, such as gastrointestinal\r\n             bleeding, obstetrics and gynecology bleeding diseases, etc.\r\n\r\n          2. During the study period, those who plan to change the dialysis method/mode or the flux\r\n             of the hemodialysis machine, such as changing from peritoneal dialysis to hemodialysis\r\n\r\n          3. Those who have any of the following heart/cerebrovascular diseases:\r\n\r\n               1. Acute coronary syndrome, stroke (except lacunar infarction) or thromboembolic\r\n                  disease (such as deep vein thrombosis or pulmonary embolism) occurred within 6\r\n                  months before screening;\r\n\r\n               2. Heart Function III of New York Society of Cardiology Or grade IV congestive heart\r\n                  failure, or severe arrhythmia, including but not limited to ventricular\r\n                  tachycardia, ventricular fibrillation, III degree atrioventricular block, etc.\r\n\r\n          4. Those who have any of the following medical or surgical history:\r\n\r\n               1. Those who plan to undergo major surgery 3 months before screening or during the\r\n                  study period (except for hemodialysis access repair) or blood transfusion\r\n                  therapy;\r\n\r\n               2. Have peritoneal dialysis related 3 months before screening Peritonitis, history\r\n                  of infection or leakage of peritoneal tube tunnel;\r\n\r\n               3. history of malignant tumor within 5 years prior to screening (except for cured\r\n                  skin basal cell carcinoma and cervical carcinoma in situ), or current assessment\r\n                  of potential malignant tumor;\r\n\r\n               4. suffering Uncontrollable or symptomatic secondary hyperparathyroidism, plasma\r\n                  iPTH>800pg/ml;\r\n\r\n               5. History of dysphagia or any gastrointestinal disease that affects drug\r\n                  absorption, history of gastric/jejunum/colon resection; f ) Those who have a\r\n                  serious infection and are receiving systemic antibiotic treatment;\r\n\r\n             g) Anyone who has participated or plans to participate in an organ transplant within 6\r\n             months; h) Have a history of chronic liver disease (such as: chronic infectious\r\n             hepatitis, chronic autoimmune liver disease, cirrhosis Or liver fibrosis); i) Patients\r\n             with a history of polycystic kidney disease.\r\n\r\n          5. Any of the following laboratory abnormalities during the screening period:\r\n\r\n               1. Folic acid <6.8nmol/L (3ng/ml) and/or VitB12<74pmol/L (100ng/ml);\r\n\r\n               2. Serum albumin <3 g/dL;\r\n\r\n               3. AIDS antibody , Treponema pallidum antibody, hepatitis B surface antigen or\r\n                  hepatitis C antibody positive for any one;\r\n\r\n               4. ALT>3ULN and/or AST>3ULN, or total bilirubin>1.5 ULN;\r\n\r\n          6. Subjects received intravenous iron supplementation within 4 weeks before screening, or\r\n             used Chinese patent medicines, androgens and anabolic hormone drugs, hypoxia-inducible\r\n             factor prolyl hydroxylase for the treatment of anemia within 4 weeks before screening\r\n             Inhibitors (such as Roxastat capsules) and other drugs (except ESAs and their\r\n             derivatives, oral irons, stable oral irons can be taken within 4 weeks before the\r\n             screening, and in the screening period and after the start of the trial drug Continue\r\n             to take the fixed dose for 6 weeks.)\r\n\r\n          7. Subjects who are expected to take BCRP inhibitors, BCRP inducers, CYP2C8 inhibitors\r\n             and inducers within 14 days before taking the test drug (or 5 half-lives of the drug,\r\n             whichever is the longest) until the end of the drug;\r\n\r\n          8. Those who have a history of drug abuse or drug abuse within 6 months before screening;\r\n\r\n          9. The mean systolic blood pressure =180 mmHg and/or the diastolic blood pressure > or =\r\n             110 mmHg of two supine blood pressure measurements at least 1 hour apart during the\r\n             screening period;\r\n\r\n         10. People with a history of severe allergic disease or drug allergy, or those who are\r\n             allergic to test drugs or their excipients;\r\n\r\n         11. Those who drink more than 14 units per week in the 3 months before screening (1 unit\r\n             of alcohol  360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of\r\n             wine), or those who cannot abstain from alcohol during the hospitalization;\r\n\r\n         12. Those who smoked more than 10 cigarettes per day in the 3 months before screening, or\r\n             who could not stop using any tobacco products during the hospitalization;\r\n\r\n         13. Women who have a positive pregnancy test or are breastfeeding, or men and women who\r\n             refuse to take effective contraceptive measures within 4 weeks from the signing of the\r\n             informed consent form to the end of the last trial drug administration;\r\n\r\n         14. Participated in other clinical trials within 3 months before screening (Definition of\r\n             participation: accepted experimental drugs or instrument);\r\n\r\n         15. Subjects may not be able to complete all research visits or procedures required by the\r\n             research protocol, and/or fail to comply with all required research procedures;\r\n\r\n         16. The investigator believes that there are other factors that are not suitable for\r\n             participating in this trial;\r\n      ","sponsor":"Sunshine Lake Pharma Co., Ltd.","sponsor_type":"Industry","conditions":"Hemodialysis|Peritoneal Dialysis","interventions":[{"intervention_type":"Drug","name":"Drug: HEC53856","description":"The 100mg dose cohort in the hemodialysis: D1 single oral administration of the investigation product 2.5h before hemodialysis; Three times a week for 6 weeks starting from D8, oral administration of the test drug 2.5h after hemodialysis.\r\nThe rest dose cohorts in the hemodialysis: Three times a week for 6 weeks starting from D1, oral administration of the investigation product 2.5h after hemodialysis.\r\nThe dose cohort in the peritoneal dialysis: Three times a week for 6 weeks starting from D1, oral administration of the investigation product after fasting."}],"outcomes":[{"outcome_type":"secondary","measure":"Cmax","time_frame":"Up to 72 hours after single and multiple drug dosing","description":"Maximum observed plasma concentration"},{"outcome_type":"secondary","measure":"Tmax","time_frame":"Up to 72 hours after single and multiple drug dosing","description":"Time of the maximum observed plasma concentration"},{"outcome_type":"secondary","measure":"T½","time_frame":"Up to 72 hours after single and multiple drug dosing","description":"Apparent terminal elimination half-life"},{"outcome_type":"primary","measure":"Incidence of Adverse Events","time_frame":"Up to 2 weeks after last dose","description":"To assess the safety and tolerability of therapy by incidence of treatment-emergent adverse events after multiple doses of HEC53856 capsule"},{"outcome_type":"secondary","measure":"AUC0-t","time_frame":"Up to 72 hours after single and multiple drug dosing","description":"Area under the concentration versus time curve (AUC) from time zero to the time of the last quantifiable concentration"},{"outcome_type":"secondary","measure":"Vz/F","time_frame":"Up to 72 hours after single and multiple drug dosing","description":"Apparent volume of distribution"},{"outcome_type":"secondary","measure":"Changes in mean hemoglobin","time_frame":"Up to 2 weeks after the last dose","description":"Changes in mean hemoglobin (Hb) relative to baseline during visit 8 and 9."},{"outcome_type":"secondary","measure":"Hemoglobin response","time_frame":"Up to 2 weeks after the last dose","description":"Percentage of subjects who met the hemoglobin response after dosing"},{"outcome_type":"secondary","measure":"E-AUC0-t","time_frame":"Up to 72 hours after single and multiple drug dosing","description":"Area under the EPO concentration versus time curve (AUC) from time zero to the time of the last quantifiable concentration"},{"outcome_type":"secondary","measure":"Emax","time_frame":"Up to 72 hours after single and multiple drug dosing","description":"Maximum observed EPO concentration"},{"outcome_type":"secondary","measure":"E-Tmax","time_frame":"Up to 72 hours after single and multiple drug dosing","description":"Time of the maximum observed EPO concentration"},{"outcome_type":"secondary","measure":"Serum lipid","time_frame":"week 6","description":"Changes in Serum lipid relative to baseline at visit 8."},{"outcome_type":"secondary","measure":"Indicators of iron","time_frame":"week 6","description":"Changes in the Indicators of iron relative to baseline at visit 8"},{"outcome_type":"secondary","measure":"High-sensitivity C-reactive protein","time_frame":"week 6","description":"Changes in the High-sensitivity C-reactive protein relative to baseline at visit 8."},{"outcome_type":"secondary","measure":"Reticulocytes","time_frame":"Up to week 8","description":"Changes in the mean Reticulocytes relative to baseline after doses."},{"outcome_type":"secondary","measure":"VEGF","time_frame":"week 6","description":"Changes in the VEGF relative to baseline after doses."}]}
{"nct_id":"NCT04935177","start_date":"2021-09-17","phase":"Phase 3","enrollment":64,"brief_title":"Renal Function in Highly Sensitized Patients 1 Year After Desensitization With Imlifidase Prior to DD Kidney Tx","official_title":"An Open-label, Controlled, Randomized Phase 3 Trial Evaluating 12-month Kidney Function in Highly Sensitized (cPRA 99.9%) Kidney Tx Patients With Positive XM Against a Deceased Donor, Comparing Desensitization Using Imlifidase With SoC","primary_completion_date":"2023-07-30","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2023-07-30","last_update":"2021-09-10","description":"An open-label, controlled, randomized Phase 3 trial evaluating 12-month kidney function in highly sensitized (cPRA 99.9%) kidney transplant patients with positive crossmatch against a deceased donor, comparing desensitization using imlifidase with standard of care","other_id":"20-HMedIdeS-17","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Open-label, controlled and randomized","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Signed Informed Consent obtained before any trial-related procedures\r\n\r\n          -  Male or female age 18-70 years at the time of screening\r\n\r\n          -  Chronic kidney disease (CKD) stage 5, highly sensitized as evaluated by standard\r\n             selection criteria, and active on the OPTN waiting list for a DD kidney transplant\r\n\r\n          -  Original calculated panel reactive antibody (cPRA) 99.9%\r\n\r\n          -  Virtual crossmatch (vXM), predictive of a positive crossmatch to an available deceased\r\n             donor (DD)\r\n\r\n          -  Willingness and ability to comply with the protocol\r\n\r\n          -  Willingness to participate in the planned 4-year extension trial\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  High dose IVIg (2 g/kg) treatment within 28 days prior to imlifidase treatment\r\n\r\n          -  Previous treatment with imlifidase\r\n\r\n          -  Breast feeding or pregnancy\r\n\r\n          -  Women of child-bearing potential not willing or able to practice FDA-approved forms of\r\n             contraception, or abstinence. Two medically acceptable methods of highly effective\r\n             contraception must be used for the duration of the study (e.g. oral, transdermal,\r\n             intravaginal, injectable or implantable contraceptive; intrauterine device;\r\n             intrauterine hormone-releasing system; vasectomized partner; bilateral tubal\r\n             occlusion; or double barrier method). For a woman to be considered postmenopausal this\r\n             ascertainment must be made according to medical records and clinical history and may\r\n             be aided by measurement of elevated postmenopausal serum gonadotropin levels (FSH).\r\n\r\n          -  ABO blood group incompatible transplantations (A2 or A2B kidneys will not be accepted\r\n             for B recipients)\r\n\r\n          -  Positive serology for human immunodeficiency virus (HIV)\r\n\r\n          -  Clinical signs of hepatitis B virus (HBV) or hepatitis C virus (HCV) infections\r\n\r\n          -  Clinical signs of cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infections\r\n\r\n          -  Positive test for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)\r\n             (according to local hospital routines)\r\n\r\n          -  Active tuberculosis\r\n\r\n          -  Severe other conditions requiring treatment and close monitoring, e.g. cardiac failure\r\n             grade 4 (New York Heart Association), unstable coronary disease or oxygen dependent\r\n             chronic obstructive pulmonary disease (COPD)\r\n\r\n          -  Any condition that in the view of the Investigator precludes transplantation\r\n\r\n          -  History of a proven hypercoagulable condition\r\n\r\n          -  Present or history of thrombotic thrombocytopenic purpura (TTP), or known familial\r\n             history of TTP\r\n\r\n          -  Intake of investigational drugs within 5 half-lives of the drug or 3 months, whichever\r\n             is the longest\r\n\r\n          -  Contemporaneous participation in a medical device study\r\n\r\n          -  Known mental incapacity or language barriers precluding adequate understanding of the\r\n             Informed Consent information and the trial activities\r\n\r\n          -  Inability by the judgement of the investigator to participate in the trial for any\r\n             other reason\r\n      ","sponsor":"Hansa Biopharma AB","sponsor_type":"Industry","conditions":"Kidney Transplantation in Highly Sensitized Patients","interventions":[{"intervention_type":"Drug","name":"Drug: Imlifidase","description":"Imlifidase is an immunoglobulin G (IgG)-degrading enzyme of Streptococcus pyogenes that is highly selective towards IgG. The cleavage of IgG generates one F(ab')2- and one homodimeric Fc-fragment and efficiently neutralizes Fc-mediated activities of IgG."},{"intervention_type":"Procedure","name":"Procedure: PLEX","description":"PLEX is performed according to the respective site's standard procedure for desensitization."},{"intervention_type":"Drug","name":"Drug: IVIg","description":"IVIg prepared from a pool of immunoglobulins from the plasma of thousands of healthy donors is administered in accordance with respective site's standard procedure for desensitization."},{"intervention_type":"Drug","name":"Drug: Anti-CD20 antibodies","description":"Rituximab and other anti-CD20 according to the respective site's standard procedure for desensitization."},{"intervention_type":"Drug","name":"Drug: Eculizumab","description":"Eculizumab according to the respective site's standard procedure for desensitization."},{"intervention_type":"Other","name":"Other: Remain on wait list","description":"Remain on wait list for a more compatible organ offer if desentization with institutional protocol is not appropriate"}],"outcomes":[{"outcome_type":"primary","measure":"Mean estimated glomerular filtration rate (eGFR) at 12 months","time_frame":"12 months after randomization","description":"eGFR is a measure of kidney function and will be compared between treatment arms.\r\neGFR will be calculated based on p-creatinine according to the modification of diet in renal disease (MDRD) equation.\r\neGFR for a kidney with normal function is 90 mL/min/1.73m2. Kidney disease is characterised by a decreased eGFR value. For randomized patients who do not undergo transplantation, lose their graft or die before 12 months, eGFR will be set to zero, consistent with kidney failure."},{"outcome_type":"secondary","measure":"Patient survival at 12 months","time_frame":"12 months after randomization","description":"Patient survival will be summarized by end of trial and compared between treatment arms."},{"outcome_type":"other","measure":"Frequency of dialysis dependency at 12 months","time_frame":"12 months after randomization","description":"Dialysis dependency is a measure of kidney function. A comparison between treatment arms will be done. Patients who are lost to follow up will be imputed as being dialysis-dependent."},{"outcome_type":"other","measure":"Graft failure-free survival at 12 months","time_frame":"12 months after randomization","description":"Graft failure-free survival is defined as the time from randomization to the first of either graft loss or death and will be compared between treatment arms."},{"outcome_type":"other","measure":"Graft survival at 12 months","time_frame":"12 months after randomization","description":"Graft survival will be compared between treatment arms in transplanted patients. Time to graft loss will be presented."},{"outcome_type":"other","measure":"Frequency of wait-list categories at 12 months","time_frame":"12 months after randomization","description":"Frequency of patients on different wait-list categories (i.e. on waitlist, temporarily delisted, delisted, dead) will be summarized by randomized treatment group"},{"outcome_type":"other","measure":"Frequency of delayed graft function","time_frame":"Within 7 days after transplantation","description":"Delayed graft function is defined as need for dialysis within 7 days of transplantation. Delayed graft function will be summarized by randomized treatment group"},{"outcome_type":"other","measure":"Antibody-mediated rejection (AMR) frequency","time_frame":"During 12 months after randomization","description":"Confirmed AMRs will be summarized by treatment. Presumed/suspected AMRs not confirmed with biopsies will be recorded as AE/SAE."},{"outcome_type":"other","measure":"Cell-mediated rejection (CMR) frequency","time_frame":"During 12 months after randomization","description":"Confirmed CMRs will be summarized by treatment. Presumed/suspected CMRs not confirmed with biopsies will be recorded as AE/SAE."},{"outcome_type":"other","measure":"Conversion of positive crossmatch test to negative","time_frame":"Within 4 hours after imlifidase treatment","description":"Imlifidase is highly efficacious in converting a positive crossmatch test to a negative. This outcome will be assessed for patients treated with imlifidase."},{"outcome_type":"other","measure":"Donor specific antibody (DSA) levels for all antibodies with a mean fluorescence intensity (MFI) of ≥1000","time_frame":"Prior first dose, 2, 4, 24, 48, 72 h and Days 5, 6, 8,15 and Months 1, 3, 6, 8, 10, and 12","description":"Analysis of DSAs will be done in serum from patients randomized to imlifidase using an IgG single antigen solid-phase immunoassay (SAB-HLA). Least square mean and standard error of DSA levels will be displayed over time."},{"outcome_type":"other","measure":"Anti-drug antibodies (ADA)","time_frame":"Prior first dose, 48 hours, Days 8, 15, and Months 1, 2, 3, 6, 8, 10, and 12","description":"Immunogenicity towards imlifidase will be assessed by the measurement of ADA levels in patient serum using a customized ImmunoCAP analysis."},{"outcome_type":"other","measure":"Imlifidase pharmacokinetics (AUC)","time_frame":"Within 24 hours prior to imlifidase treatment and up to Day 15","description":"AUC = Area under the imlifidase plasma concentration versus time curve"},{"outcome_type":"other","measure":"Imlifidase pharmacokinetics (Cmax)","time_frame":"Within 24 hours prior to imlifidase treatment and up to Day 15","description":"Cmax = Maximum observed plasma concentration of imlifidase following dosing"},{"outcome_type":"other","measure":"Imlifidase pharmacokinetics (tmax)","time_frame":"Within 24 hours prior to imlifidase treatment and up to Day 15","description":"tmax = Time point for maximum observed plasma concentration of imlifidase following dosing"},{"outcome_type":"other","measure":"Imlifidase pharmacokinetics (t1/2)","time_frame":"Within 24 hours prior to imlifidase treatment and up to Day 15","description":"t1/2 = Terminal half-life of imlifidase"},{"outcome_type":"other","measure":"Imlifidase pharmacokinetics (CL)","time_frame":"Within 24 hours prior to imlifidase treatment and up to Day 15","description":"CL = Clearance of imlifidase"},{"outcome_type":"other","measure":"Imlifidase pharmacokinetics (Vz)","time_frame":"Within 24 hours prior to imlifidase treatment and up to Day 15","description":"Vz = Apparent volume of distribution during terminal phase"},{"outcome_type":"other","measure":"Imlifidase pharmacodynamics","time_frame":"Within 24 hours prior to imlifidase treatment and up to Day 10","description":"Concentration of IgG in patient serum will be measured. Scoring of IgG fragments will be done."},{"outcome_type":"other","measure":"Safety as measured by adverse events (AEs)","time_frame":"From signing informed consent to 12 months","description":"Safety is assessed as type, frequency and intensity of adverse events (AEs)/Serious adverse events (SAEs) including clinically relevant changes in clinical laboratory tests, vital signs and ECG)"},{"outcome_type":"other","measure":"Safety as measured by serious adverse events (SAEs)","time_frame":"From signing informed consent to 12 months","description":"Safety is assessed as type and frequency serious adverse events (SAEs)"},{"outcome_type":"other","measure":"Safety as measured by other adverse events (AEs)","time_frame":"From signing informed consent to 12 months","description":"Safety is assessed as type and frequency of other adverse events (AEs) - i.e. not including SAEs"},{"outcome_type":"other","measure":"Change in patient-reported life participation, as measured by PROMIS-SF-8a","time_frame":"At pre-screening and at 12 months after randomization","description":"The PROMIS Social Health domain \"Ability to participate in social roles & activities PROMIS-SF-8\" will be used as a measure of the patients' health related quality of life."}]}
{"nct_id":"NCT04815278","start_date":"2021-09-17","phase":"N/A","enrollment":600,"brief_title":"NC Works4Health: Reducing Chronic Disease Risks in Socioeconomically Disadvantaged, Unemployed Populations","official_title":"NC Works4Health: Reducing Chronic Disease Risks in Socioeconomically Disadvantaged, Unemployed Populations","primary_completion_date":"2025-09-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2025-09-30","last_update":"2021-09-22","description":"The proposed study, NC Works4Health (NCW4H), builds on the strengths of long-standing academic-community research partnerships between this UNC at Chapel Hill (UNC) team of investigators and key stakeholders across health, social service, employment, and economic development sectors. The overall goal of this study is to test the effectiveness of a multilevel intervention that can be readily adopted by communities to reduce chronic disease risks in socioeconomically disadvantaged populations by (a) embedding prevention efforts in DSS-E programs at the individual level, and (b) enhancing supervisor supports for DSS-E hires at the employer level. Interventions at each level, and their joint effects, are designed to mitigate the psychological, behavioral, and clinically relevant risks for chronic disease onset, morbidity, and comorbidity that accrue with unemployment and the employment-entry transition.","other_id":"18-3058","allocation":"Randomized","intervention_model":"Factorial Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","intervention_model_description":"Random 2x2 factorial design. The temporal nature of the phenomenon under study requires individuals (DSS-E participants) are first randomized to the individual-level treatment group, follow them as they are naturally hired into employment settings, and then enroll / randomize / allocate employers to the employer-level treatment group","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  receiving DSS-E services\r\n\r\n          -  between the age of 18 and 55 years old\r\n\r\n          -  unemployed\r\n\r\n          -  fluent and able to read English\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  receiving or applied for disability benefits\r\n\r\n          -  pregnant\r\n\r\n          -  Any of the following chronic conditions: severe high blood pressure (with a reading of\r\n             180/110 or higher in the past 6 months), a health condition or injury that has left\r\n             you unsteady, or unbalanced when you walk, a history of falling in the past 6 months,\r\n             cancer that is actively being treated with chemotherapy of radiation to your chest or\r\n             abdomen (stomach area), inflammatory bowel disease (such as Crohn's disease, or\r\n             ulcerative colitis), an implanted cardiac defibrillator (a small device placed under\r\n             the skin on your chest to help your heart function)\r\n      ","sponsor":"University of North Carolina, Chapel Hill","sponsor_type":"Other","conditions":"Psychological Distress|Chronic Disease|Diabetes","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Immediate Chronic Disease Prevention Program (CDPP)","description":"The CDPP is an adaptation of the Diabetes Prevention Program (DPP). It will take place over a 24 week period and involve online instruction and individualized lifestyle coaching sessions. The online classroom curriculum includes 8 modules: Goal setting, self-monitoring and problem solving (M1), Managing stress and negative thoughts (M2), Healthy eating (M3), Taking more steps (M4), Keeping alcohol in check (M5), Lifestyle change (M6), Taking charge of what (and who) is around you (M7), and Staying motivated (M8). The lifestyle coaches will meet in person and over the phone intermittently over the 24 week period (Weeks 2, 4, 6, 10, 12, 16, 24)."},{"intervention_type":"Behavioral","name":"Behavioral: Workplace Equity, Job and Health Supports Employer Intervention","description":"The employer intervention combines implicit bias awareness training for supervisors of hired DSS-E clients, and regular, structured, interactions between supervisors and DSS-E hires."},{"intervention_type":"Behavioral","name":"Behavioral: Delayed, attenuated Chronic Disease Prevention Program (CDPP)","description":"Participants will have access to a delayed, attenuated online-only version of the CDPP at the time they complete the 12 month data collection. This version will provide all modules, self-monitoring options (including through use of a Fitbit contingent on the completion of the 12 month data collection) but will not include face-to-face or phone lifestyle coach sessions."}],"outcomes":[{"outcome_type":"secondary","measure":"Scores on Health Self-Regulation Scale","time_frame":"Up to 12 months","description":"Health Self-Regulation will be gauged by the Index of Self-Regulation (ISR) which measures Stimulus Control, Reconditioning, and Behavioral Monitoring self-regulation domains. The ISR is a 12- item measure rated on a 6-point scale from \"Strongly Disagree\" (score 1) to \"Strongly Agree\" (score 6). Higher scores indicate higher levels of self-regulation while lower scores indicate lower levels of self-regulation. Scores range from 12-72. Outcome data will be collected at Baseline (Month 0), and Months 3, 6, and 12."},{"outcome_type":"primary","measure":"Mean Psychological Distress Scores at Baseline","time_frame":"Baseline (Month 0)","description":"The Patient Health Questionnaire (PHQ-8) is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. It is an 8 item scale with each item rated on a 4 point scale from \"Not at all\" (score 0) to \"Nearly every day\" (score 3). Higher scores indicate higher levels of depression while lower scores indicate lower levels of depression. Scores range from 0-24.\r\nThe Generalized Anxiety Disorder (GAD-7) is a 7 item instrument that is used to measure or assess the severity of generalized anxiety disorder (GAD). Each item asks the individual to rate the severity of his or her symptoms over the past two weeks. Items are rated on a 4 point scale from \"Not at all\" (score 0) to \"Nearly every day\" (score 3). Higher scores indicate higher levels of anxiety while lower scores indicate lower levels of anxiety. Scores range from 0-21.\r\nTo obtain an aggregate score for Psychological Distress, the PHQ & GAD will be combined. Scores will range from 0-45."},{"outcome_type":"primary","measure":"Mean Psychological Distress Scores at Month 3","time_frame":"3 Months","description":"The Patient Health Questionnaire (PHQ-8) is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. It is an 8 item scale with each item rated on a 4 point scale from \"Not at all\" (score 0) to \"Nearly every day\" (score 3). Higher scores indicate higher levels of depression while lower scores indicate lower levels of depression. Scores range from 0-24.\r\nThe Generalized Anxiety Disorder (GAD-7) is a 7 item instrument that is used to measure or assess the severity of generalized anxiety disorder (GAD). Each item asks the individual to rate the severity of his or her symptoms over the past two weeks. Items are rated on a 4 point scale from \"Not at all\" (score 0) to \"Nearly every day\" (score 3). Higher scores indicate higher levels of anxiety while lower scores indicate lower levels of anxiety. Scores range from 0-21.\r\nTo obtain an aggregate score for Psychological Distress, the PHQ & GAD will be combined. Scores will range from 0-45."},{"outcome_type":"primary","measure":"Mean Psychological Distress Scores at Month 6","time_frame":"Month 6","description":"The Patient Health Questionnaire (PHQ-8) is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. It is an 8 item scale with each item rated on a 4 point scale from \"Not at all\" (score 0) to \"Nearly every day\" (score 3). Higher scores indicate higher levels of depression while lower scores indicate lower levels of depression. Scores range from 0-24.\r\nThe Generalized Anxiety Disorder (GAD-7) is a 7 item instrument that is used to measure or assess the severity of generalized anxiety disorder (GAD). Each item asks the individual to rate the severity of his or her symptoms over the past two weeks. Items are rated on a 4 point scale from \"Not at all\" (score 0) to \"Nearly every day\" (score 3). Higher scores indicate higher levels of anxiety while lower scores indicate lower levels of anxiety. Scores range from 0-21.\r\nTo obtain an aggregate score for Psychological Distress, the PHQ & GAD will be combined. Scores will range from 0-45."},{"outcome_type":"primary","measure":"Mean Psychological Distress Scores at Month 12","time_frame":"Month 12","description":"The Patient Health Questionnaire (PHQ-8) is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. It is an 8 item scale with each item rated on a 4 point scale from \"Not at all\" (score 0) to \"Nearly every day\" (score 3). Higher scores indicate higher levels of depression while lower scores indicate lower levels of depression. Scores range from 0-24.\r\nThe Generalized Anxiety Disorder (GAD-7) is a 7 item instrument that is used to measure or assess the severity of generalized anxiety disorder (GAD). Each item asks the individual to rate the severity of his or her symptoms over the past two weeks. Items are rated on a 4 point scale from \"Not at all\" (score 0) to \"Nearly every day\" (score 3). Higher scores indicate higher levels of anxiety while lower scores indicate lower levels of anxiety. Scores range from 0-21.\r\nTo obtain an aggregate score for Psychological Distress, the PHQ & GAD will be combined. Scores will range from 0-45."},{"outcome_type":"primary","measure":"Weight at Baseline","time_frame":"Baseline (Month 0)","description":"Weight will be measured using the Tanita WB-800 Plus professional grade scale. Lightweight and portable, it has a weight capacity of 660 lbs, and has been used in studies of weight gain prevention by others on the research team."},{"outcome_type":"primary","measure":"Weight at Month 3","time_frame":"Month 3","description":"Weight will be measured using the Tanita WB-800 Plus professional grade scale. Lightweight and portable, it has a weight capacity of 660 lbs, and has been used in studies of weight gain prevention by others on the research team."},{"outcome_type":"primary","measure":"Weight at Month 6","time_frame":"Month 6","description":"Weight will be measured using the Tanita WB-800 Plus professional grade scale. Lightweight and portable, it has a weight capacity of 660 lbs, and has been used in studies of weight gain prevention by others on the research team."},{"outcome_type":"primary","measure":"Weight at Month 12","time_frame":"Month12","description":"Weight will be measured using the Tanita WB-800 Plus professional grade scale. Lightweight and portable, it has a weight capacity of 660 lbs, and has been used in studies of weight gain prevention by others on the research team."},{"outcome_type":"primary","measure":"Blood Pressure at Baseline","time_frame":"Baseline (Month 0)","description":"Blood Pressure will be assessed using the American Heart Association Guidelines for BP measurement and the Omron HEM-705CPN, which meets strict calibration standards and is validated at +/- 3-5 mmHg (millimeters of mercury)."},{"outcome_type":"primary","measure":"Blood Pressure at Month 3","time_frame":"Month 3","description":"Blood Pressure will be assessed using the American Heart Association Guidelines for BP measurement and the Omron HEM-705CPN, which meets strict calibration standards and is validated at +/- 3-5 mmHg (millimeters of mercury)."},{"outcome_type":"primary","measure":"Blood Pressure at Month 6","time_frame":"Month 6","description":"Blood Pressure will be assessed using the American Heart Association Guidelines for BP measurement and the Omron HEM-705CPN, which meets strict calibration standards and is validated at +/- 3-5 mmHg (millimeters of mercury)."},{"outcome_type":"primary","measure":"Blood Pressure at Month 12","time_frame":"Month 12","description":"Blood Pressure will be assessed using the American Heart Association Guidelines for BP measurement and the Omron HEM-705CPN, which meets strict calibration standards and is validated at +/- 3-5 mmHg (millimeters of mercury)."},{"outcome_type":"secondary","measure":"Scores on Situational Stress Scale","time_frame":"Up to 12 months","description":"Situational stress will be measured by the Perceived Stress Scale (PSS), a 14 item measure of the extent to which the circumstances of one's life are appraised as stressful. Each item is rated on a 5-point scale from \"Never\" (score 0) to \"Very Often\" (score 4). Higher scores indicate higher levels of stress while lower scores indicate lower levels of stress. Scores range from 0-56. Outcome data will be collected at Baseline (Month 0), and Months 3, 6, and 12."},{"outcome_type":"secondary","measure":"Scores on Coping Strategies Scale","time_frame":"Up to 12 months","description":"Coping style will be measured by the Coping Strategies Inventory (CSI), a 32 item measure designed to assess coping thoughts and behaviors in response to a specific stressor. Each item is rated on a 5-point scale from \"Not at All\" (score 1) to \"Very Much\" (score 5). Higher scores indicate higher levels of coping while lower scores indicate lower levels of coping. Scores range from 32-160. Outcome data will be collected at Baseline (Month 0), and Months 3, 6, and 12."},{"outcome_type":"secondary","measure":"Number of Steps Taken as Determined by ActiGraph Accelerometer","time_frame":"Up to 12 months","description":"ActiGraph wGT3X-BT, 3-axis accelerometers will measure physical activity over 3 days. These are small, water resistant, lightweight, and worn on the wrist or hip. Data download electronically; algorithm generates mean number of steps taken. Measurements will be assessed for a 3 day period at Baseline (Month 0), and Months 3, 6, and 12."},{"outcome_type":"secondary","measure":"Physical Activity Intensity as Determined by ActiGraph Accelerometer","time_frame":"Up to 12 months","description":"ActiGraph wGT3X-BT, 3-axis accelerometers will measure physical activity over 3 days. These are small, water resistant, lightweight, and worn on the wrist or hip. Data download electronically; algorithm generates mean physical activity intensity values using using units of Moderate to Vigorous Physical Activity (MVPA). Measurements will be assessed for a 3 day period at Baseline (Month 0), and Months 3, 6, and 12."},{"outcome_type":"secondary","measure":"Sedentary Bouts as Determined by ActiGraph Accelerometer","time_frame":"Up to 12 months","description":"ActiGraph wGT3X-BT, 3-axis accelerometers will measure physical activity over 3 days. These are small, water resistant, lightweight, and worn on the wrist or hip. Data download electronically; algorithm generates sedentary \"bouts\" in units of time (seconds). Measurements will be assessed for a 3 day period at Baseline (Month 0), and Months 3, 6, and 12."},{"outcome_type":"secondary","measure":"MET Rate as Determined by ActiGraph Accelerometer","time_frame":"Up to 12 months","description":"ActiGraph wGT3X-BT, 3-axis accelerometers will measure Metabolic Equivalent (MET) physical activity over 3 days. These are small, water resistant, lightweight, and worn on the wrist or hip. Data download electronically; algorithm generates a mean MET rate. Measurements will be assessed for a 3 day period at Baseline (Month 0), and Months 3, 6, and 12."},{"outcome_type":"secondary","measure":"Dietary Intake Log","time_frame":"Up to 12 months","description":"NCI's Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24®) will collect all dietary intake data over 3 days. With portion size images, accuracy of the ASA24® (+/- 3.7g) now supersedes that of the long-standing gold standard. Outcome data will be collected at Baseline (Month 0), and Months 3, 6, and 12."},{"outcome_type":"secondary","measure":"Scores on Alcohol Use Scale","time_frame":"Up to 12 months","description":"The Patient-Reported Outcomes Measurement Information System (PROMIS) Alcohol Use scale will assess the consumption quantity and frequency, and problem drinking. It is a 14 item measure rated on a 5-point scale from \"Never\" (score 1) to \"Almost Always\" (score 5). Higher scores indicate higher levels of alcohol use while lower scores indicate lower levels of alcohol use. Scores range from 14-70. Outcome data will be collected at Baseline (Month 0) and a Months 3, 6, and 12."},{"outcome_type":"secondary","measure":"Scores on Smoking Quantity Scale","time_frame":"Up to 12 months","description":"The Patient-Reported Outcomes Measurement Information System (PROMIS) Smoking Module assesses smoking quantity. The PROMIS Smoking module is a 10 item measure rated on a 5-point scale from \"Never\" (score 1) to \"Always\" (score 5). Higher scores indicate higher levels of smoking while lower scores indicate lower levels of smoking. Scores range from 10-50. These scores will only be reported for participants that indicate they are current smokers. Outcome data will be collected at Baseline (Month 0), and Months 3, 6, and 12."},{"outcome_type":"secondary","measure":"Responses to Motivation to Stop Smoking","time_frame":"Up to 12 months","description":"The Motivation to Stop Scale (MTSS) assesses readiness to quit. The MTSS is a 1 item multiple choice measure with 7 options. These scores will only be reported for participants that indicate they are current smokers. Outcome data will be collected at Baseline (Month 0), and Months 3, 6, and 12."},{"outcome_type":"secondary","measure":"Scores on Employment Functioning Scale","time_frame":"Up to 12 months","description":"The Work Limitations Questionnaire (WLQ) captures health-related absenteeism and presenteeism. The WLQ is a 25 item measure rated on a 5-point scale from \"None of the time\" (score 1) to \"All of the time\" (score 5). Higher scores indicate higher levels of employment functioning while lower scores indicate lower levels of employment functioning. Average item scores will be calculated to a 25-125 range. Outcome data will be collected at Baseline (Month 0), and Months 3, 6, and 12."},{"outcome_type":"secondary","measure":"Mean Change in Perceived Discrimination Scores","time_frame":"Up to 12 Months","description":"The Perceived Supervisor Discrimination scale (adapted) is an aggregate measure of two short measures: the job harassment index and the treated unfairly on job index. The job harassment index consists of 2 items and the treated unfairly on job index consists of 3 items. Each is rated on the same 5 point scale from Never (score 0) to 1+ times a week (score 4). Higher scores indicate higher occurrences of harassment/unfair treatment. Scores range from 0-20. Because the 2 sub-scales are rated on the same 5-point scale, the scores will be added together for an aggregate score. Measurements will be collected at Baseline (Month 0), and Months 3, 6, and 12."},{"outcome_type":"secondary","measure":"Mean Change in Perceived Supervisor Support Scores","time_frame":"Up to 12 Months","description":"The Perceived Supervisor Support Scale is a 12 item measure that quantitatively captures employee's relationship with their supervisor and the extent to which they believe their supervisor is supportive of them. The scale is adapted from the Perceived Organizational Support scale by replacing the word \"Organization\" with \"Supervisor. Respondents indicate their agreement with each item using a 7-point Likert-type scale (0=strongly disagree, 6=strongly agree). Higher scores indicate higher levels of agreement. Scores range from 0-72. Measurements will be assessed at Baseline (Month 0), and Months 3, 6, and 12."},{"outcome_type":"secondary","measure":"Proportion of Days Employed","time_frame":"Up to 12 months","description":"Employment duration will be measured by Person-Time Employed (proportion of days employed regardless of breaks in employment) over the entire one year study period. Employment start and stop dates will be collected at each of the data collection time points (Baseline (Month 0), and Months 3, 6, and 12). Employment duration proportion will be calculated after the 12 month data collection."},{"outcome_type":"secondary","measure":"Weeks of Continuous Employment","time_frame":"Up to 12 months","description":"Employment duration will be measured by Continuous Employment (number of consecutive weeks employed, with any reported work in a given week counted as a positive week of employment) over the entire study period. Continuous weeks of employment will be collected at each of the data collection time points (Baseline (Month 0), and Months 3, 6, and 12). Weeks continuous employment will be calculated after the 12 month data collection."},{"outcome_type":"secondary","measure":"Number of Times of Healthcare Utilization","time_frame":"Up to 12 months","description":"Participants will self-report their health care utilization by point of service in the previous three months (e.g., ER visits, meds). Outcome data will be collected at Baseline (Month 0), and Months 3, 6, and 12."},{"outcome_type":"secondary","measure":"Total Amount of Supplementary Out-of-pocket costs","time_frame":"Up to 12 months","description":"Participants will self-report total amount of supplementary out-of-pocket costs (e.g., dietary supplements, gym classes, health-related equipment) in the previous three months. Outcome data will be collected at Baseline (Month 0), and Months 3, 6, and 12."},{"outcome_type":"secondary","measure":"Scores on Organizational Citizenship Behaviors Checklist","time_frame":"Up to 12 months","description":"The Organizational Citizenship Behaviors Checklist (OCB-C) Scale assesses the frequency of employee behaviors that go above and beyond job responsibilities. The OCB-C is a 20-item scale that is scored on a 5-point Likert scale (1= Never, 5= Every day). High scores indicate more organizational citizenship behaviors. Low scores indicate less organizational citizenship behaviors. Scores range from 20-100. Outcome data will be collected at Baseline (Month 0), and Months 3, 6, and 12."},{"outcome_type":"secondary","measure":"Scores on General Health","time_frame":"Up to 12 months","description":"The Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health assesses general health. The PROMIS Global Health module is a 10 item measure rated on a 5-point scale from \"Excellent\" (score 1) to \"Poor\" (score 5). Higher scores indicate poorer health while lower scores indicate better health. Scores range from 10-50. Outcome data will be collected at Baseline (Month 0), and Months 3, 6, and 12."},{"outcome_type":"secondary","measure":"Health Care Provider Status","time_frame":"Up to 12 months","description":"Participants will answer a single item that asks if they currently have a primary health care provider. Answer choices are binary; yes or no. This item will not be scored. Outcome data will be collected at Baseline (Month 0), and Months 3, 6, and 12."},{"outcome_type":"secondary","measure":"Chronic Conditions","time_frame":"At Baseline (Month 0)","description":"Participants will answer a single item that asks for all chronic conditions they have ever had that have been diagnosed by a health care professional. There is a list of 28 chronic condition options. Participants may choose multiple conditions. This item will not be scored."},{"outcome_type":"secondary","measure":"Health Management Apps/Programs/Wearables Use","time_frame":"Up to 12 months","description":"The Health Management Use scale measures how frequently participants have used apps, gadgets, or strategies to manage their health in the last 3 months. It is a 13 item measure rated on a 4-point scale from \"Used daily or almost daily\" (score 1) to \"Have not used\" (score 4) scale. Higher scores indicate less health management use while lower scores indicate more health management use. Scores range from 13-52. Outcome data will be collected at Baseline (Month 0), and Months 3, 6, and 12."},{"outcome_type":"secondary","measure":"Medication Covariates","time_frame":"Up to 12 months","description":"A single item about current medications: Diabetes (Thiazolidinediones, Sulfonylureas, insulin), Anti-psychotics (Haloperidol,Clozapine, Risperidone, Olanzapine, Quetiapine, Lithium, Valproic acid, Carbamezapine), Anti-depressants (Amitriptyline, Imipramine, Paroxetine, Escitalopram, Citalopram, Mirtazapine, Sertraline), Anti-epileptics (Valproate, Divalproex, Carbamazepine, Gabapentin, nortriptyline, valproic acid), Steroids (Prednisone, prednisolone, Cortisone, methylprednisolone, Anti-hypertensives, Propranolol, Metoprolol, Amiodipine, Conidine, atenolol), Diabetes (Metformin, Liraglutide), Bronchodilator (Theophylline), Stimulants (Methylphenidate, Dextroamphetamine), Anticonvulsant (Topiramate), Antidepressant (Bupropion, Fluoxetine), Anti-inflammatory (Sulphasalazine), Other weight loss medications (Orlistat, Lorcaserin, Phentermine-topiramate, Naltrexone-bupropion). The item is multiple choice. Outcome data will be collected at Baseline (Month 0), and Months 3, 6, and 12."},{"outcome_type":"other","measure":"Responses to CDC Scorecard","time_frame":"Up to 60 months","description":"The Center for Disease Control and Prevention (CDC) ScoreCard consists of 154 yes or no binary questions that measure worksite health strategies in 16 areas being implemented in employer organizations. It will be used to assess and adjust for (if necessary) employer group equivalence, and for guiding generalizing findings to a broader population of employers. Outcome data will be collected at Baseline (Month 0) and every 12 months."},{"outcome_type":"other","measure":"Scores on Chronic Financial Strain Scale","time_frame":"Up to 12 months","description":"The Chronic Financial Strain (CFS) scale (5 items) assesses the frequency that funds are unavailable to purchase basic necessities (i.e., food, medical care, clothing). Items are rated on a 5-point scale from \"Never\" (score 0) to \"Always\" (score 4). Lower scores indicate lower levels of financial strain while higher scores indicate higher levels of financial strain. Scores range from 0-20. Outcome data will be collected at Baseline (Month 0), and Months 3, 6, and 12."},{"outcome_type":"other","measure":"Scores on Effort-Reward Imbalance Scale","time_frame":"Up to 12 months","description":"The Effort-Reward Imbalance-Short (ERI-S) scale (16 items) will measure work effort, reward, and commitment. Item responses are scored on a 4-point Likert-type scale (1 = strongly disagree, 4 = strongly agree). High scores indicate high effort and high reward. Scores range from 16-64. Outcome data will be collected at Baseline (Month 0), and Months 3, 6, and 12."}]}
{"nct_id":"NCT05025293","start_date":"2021-09-15","phase":"Phase 4","enrollment":300,"brief_title":"Zoledronate Early to Hip Fracture Patients - Safe and Effective?","official_title":"Zoledronate Early to Hip Fracture Patients - Safe and Effective? A Double-blinded Randomized Controlled Treatment Strategy Trial on Zoledronate in Hip Fracture Patients","primary_completion_date":"2024-12-01","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2024-12-01","last_update":"2021-08-27","description":"To prevent hip fracture patients for having another fracture, secondary fracture preventing medication should be given as soon as possible. Zoledronate is the most efficient bisphosphonate and is given as an intravenous infusion once yearly. However, the appropriate time to initiate zoledronate treatment after a hip fracture has not yet been established. To clarify the optimal timing of zoledronate to hip fracture patients we have designed a double-blinded, placebo-controlled randomized non-inferiority trial to compare if zoledronate administered early (within 3 days) after hip fracture surgery is as good as zoledronate given late (3 months) after hip fracture surgery.","other_id":"2018/2234","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Quadruple","intervention_model_description":"Double-blinded randomized controlled non-inferiority trial","sampling_method":"","gender":"All","minimum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Low energy hip fracture\r\n\r\n          -  Surgery within 72 hours\r\n\r\n          -  >50 years old norwegian\r\n\r\n          -  Women age 50-60 must be postmenopausal or not pregnant\r\n\r\n          -  Acceptable kidney function (estimated GFR >=35) and calcium levels\r\n\r\n          -  Fit to complete the follow-up judged by the recruiting physician\r\n\r\n          -  Signed informed consent by the patient or the next of kin\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Metal in the opposite hip\r\n\r\n          -  Anti-osteoporosis treatment with bisphosphonates, denosumab, teriparatide,\r\n             abaloparatide or romosozumab within the last 10 years\r\n\r\n          -  Glucocorticoid therapy\r\n\r\n          -  Too sick to receive treatment with zoledronate judged by the recruiting or treating\r\n             physician\r\n\r\n          -  Any other contraindication listed on the SmPC of the IMP(s) including pregnancy\r\n\r\n          -  Participating in another trial that might affect the current study\r\n      ","sponsor":"Lene Bergendal Solberg","sponsor_type":"Other","conditions":"Hip Fractures|Osteoporosis","interventions":[{"intervention_type":"Drug","name":"Drug: Zoledronic Acid 5Mg/Bag 100Ml Inj","description":"100ml Zoledronic acid (5mg/100ml) administered intravenously"},{"intervention_type":"Drug","name":"Drug: sodium chloride","description":"100ml NaCl 9mg/ml administered intravenously"}],"outcomes":[{"outcome_type":"primary","measure":"Difference between the two groups (ZOLearly vs ZOLlate) in proportion of patients having P1NP>35µg/L 12 months after treatment with zoledronate","time_frame":"12 months after treatment with zoledronate","description":"Measured by the bone turnover marker N-terminal propeptide of type 1 procollagen (P1NP) (µg/ml) in blood samples"},{"outcome_type":"secondary","measure":"Grade of early mobilization","time_frame":"1-30 days","description":"Measured by Cumulated Ambulation Score (CAS) in hospital and at discharge from hospital. The score range from 0 to 6, where 6 is the best. The patient is scored daily during the stay in hospital."},{"outcome_type":"secondary","measure":"Delirium assessment","time_frame":"1-30 days","description":"Number of patients with delirium assessed by 4 \"A\" test (4AT) in hospital"},{"outcome_type":"secondary","measure":"Difference between the two groups in proportion of patients having CTX>0.28µg/L 12 months after treatment with zoledronate","time_frame":"12 months after treatment with zoledronate","description":"Measured by the bone turnover marker C-telopeptide of type 1 collagen (CTX) (µg/ml) in blood samples"},{"outcome_type":"secondary","measure":"Change in bone mineral density (BMD)","time_frame":"12 months after treatment with zoledronate","description":"Measured by dual-energy x-ray absorbtiometry (DXA) in g/cm2 right after hip fracture surgery and after 12 months with zoledronate treatment"},{"outcome_type":"secondary","measure":"Grade of mobilization and rehabilitation","time_frame":"3 months after fracture surgery","description":"Measured by Time-up-and-go (TUG) test"},{"outcome_type":"secondary","measure":"Fever (T> 38'C) during hospital stay for fracture surgery","time_frame":"1-30 days","description":"Temperature measured in 'C in each patient"},{"outcome_type":"secondary","measure":"Use of antibiotics during hospital stay for fracture surgery","time_frame":"1-30 days","description":"Measure duration of antibiotic treatment in each patient"},{"outcome_type":"secondary","measure":"Hospital stay after hip fracture surgery","time_frame":"1-30 days","description":"Measure time from admission to discharge from hospital and time from hip fracture surgery to discharge from hospital"},{"outcome_type":"secondary","measure":"Time to readmission to hospital (any department) after first discharge","time_frame":"15 months","description":"Measure time to first readmission for each patient"},{"outcome_type":"secondary","measure":"Number of readmissions to hospital (any department) after first discharge","time_frame":"15 months","description":"Measure number of readmissions for each patient"},{"outcome_type":"secondary","measure":"Time to new fracture","time_frame":"15 months","description":"Measure time to first new fracture after the index fracture for each patient"},{"outcome_type":"secondary","measure":"Total number of new fractures","time_frame":"15 months","description":"Measure total number of new fractures"},{"outcome_type":"secondary","measure":"Deaths","time_frame":"15 months","description":"Measure total number of deaths"},{"outcome_type":"other","measure":"Health-related quality of life","time_frame":"12 months after treatment with zoledronate","description":"Measured by EQ-5D-5L"},{"outcome_type":"other","measure":"Time to fracture healing for the patients with osteosynthesis","time_frame":"3 months after fracture treatment","description":"Examined by x-rays and TUG test"}]}
{"nct_id":"NCT04980521","start_date":"2021-09-15","phase":"N/A","enrollment":500,"brief_title":"Promoting Radon Testing Via Smartphone App: A Clinical Trial in a High Radon State","official_title":"Promoting Radon Testing Via Smartphone App: A Clinical Trial in a High Radon State","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2022-05-31","last_update":"2021-07-28","description":"This research will compare (1) the effectiveness of a mobile radon-education app (vs. traditional brochures) and (2) that of the radon app with in-app reminders (vs. the radon app without in-app reminders and the no app use with postal reminders) to increase radon awareness and testing among North Dakotans. The prevalence of exceptionally high levels of residential radon in ND, coupled with public's poor understanding of this hazard, is a critical public health problem.","other_id":"CTR radon DaCCoTA","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  The principal eligibility criterion is that participants own a smartphone.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  The principal exclusion criterion is previous testing for radon within the past two\r\n             years.\r\n      ","sponsor":"University of North Dakota","sponsor_type":"Other","conditions":"Lung Cancer","interventions":[{"intervention_type":"Other","name":"Other: The radon app","description":"Participants will be asked to use the radon app."},{"intervention_type":"Other","name":"Other: Print brochure","description":"Participants will receive print brochures."}],"outcomes":[{"outcome_type":"primary","measure":"Ordering a free radon test kit","time_frame":"Through the study completion - 3 months","description":"The rate at which participants order a free radon test kit"},{"outcome_type":"primary","measure":"Using the radon test kit","time_frame":"Through the study completion - 3 months","description":"The rate at which participants use the radon test kit to test their houses"},{"outcome_type":"primary","measure":"Change from baseline radon knowledge at 3 months","time_frame":"Change from baseline knowledge level to the completion of study at 3 months","description":"Participants' knowledge about radon and its dangers, how to protect themselves from radon, etc."}]}
{"nct_id":"NCT04868630","start_date":"2021-09-10","enrollment":80,"brief_title":"Calibration of the Average Breathing Rate Measurement of the Cloud DX Pulsewave Health Monitor (PAD-2A) Device (CCV-3)","official_title":"Calibration of the Average Breathing Rate Measurement of the Cloud DX Pulsewave Health Monitor (PAD-2A) Device (CCV-3)","primary_completion_date":"2022-09-30","study_type":"Observational","rec_status":"Recruiting","completion_date":"2022-09-30","last_update":"2021-09-20","description":"The purpose of this study is to calibrate the average breathing rate measurement of the PAD-2A device to be within 2 breaths per minute of clinical capnography breathing rate measurements.","other_id":"RS#: 2020-2908; R#: 100948","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":19,"population":"For the PAD-2A device calibration phase of the study, we will recruit and consent\r\n        approximately 80 adult male and female patient participants ( 19 years of age; minimum 30%\r\n        male/female) who are referred to the Atlantic Sleep Centre or the Respiratory Clinic at the\r\n        Saint John Regional Hospital (SJRH) and who are willing to volunteer to participate in the\r\n        study. Eligibility of participants will be determined based on the inclusion/exclusion\r\n        criteria of the study, as described below.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adults  19 years of age (minimum 30% male/female)\r\n\r\n          -  Wrist circumference between 13.5cm - 23cm (5.3 in. - 9.1in.)\r\n\r\n               -  At least 20% of total participants, greater than 20.6cm\r\n\r\n               -  At least 20% of total participants, between 18.3cm & 20.6cm\r\n\r\n               -  At least 20% of total participants, between 15.9cm & 18.3cm\r\n\r\n               -  At least 20% of total participants, less than 15.9cm\r\n\r\n               -  At least 10% of total participants, greater than 21.8cm\r\n\r\n               -  At least 10% of total participants, less than 14.7cm\r\n\r\n          -  Willing to volunteer to participate and to sign the study specific informed consent\r\n             form\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Wrist circumference less than 13.5cm (5.3 in.) or greater than 23cm (9.1 in)\r\n\r\n          -  Hand or body tremors\r\n\r\n          -  Canadian Cardiovascular Society (CCS) grade III or IV angina pectoris (chest pain)\r\n\r\n          -  Unexplained shortness of breath at rest\r\n\r\n          -  History of seizures (except childhood febrile seizures)\r\n\r\n          -  Epilepsy\r\n\r\n          -  History of unexplained syncope (fainting)\r\n\r\n          -  Pregnant\r\n\r\n          -  A musculoskeletal disorder that prevents a non-invasive device to be inflated/deflated\r\n             on the arm\r\n\r\n          -  Unwilling to volunteer to participate and to sign the study specific informed consent\r\n             form\r\n      ","sponsor":"Cardiovascular Research New Brunswick","sponsor_type":"Other","conditions":"Outpatients","interventions":[{"intervention_type":"Device","name":"Device: Pulsewave Health Monitor (PAD-2A) Device","description":"This is an observational study of the average breathing rate measurement of a non-invasive wrist cuff device. The purpose of this study is to calibrate the average breathing rate measurement of the Pulsewave Health Monitor (PAD-2A) wrist cuff device with the breathing rate measurement of a standard clinical capnography device. Additionally, we will also compare the average breathing rate measurement of the capnography device with other standard clinical respiratory devices (i.e. nasal pressure transducer, thermistor, and respiratory inductance plethysmography (RIP) belts of the chest and abdomen)."}],"outcomes":[{"outcome_type":"primary","measure":"Breathing rate","time_frame":"From the start of cuff deflation to the end of cuff deflation (approximately 60 seconds).","description":"Non-invasive Pulsewave Health Monitor (PAD-2A) wrist cuff device (breaths per minute)"},{"outcome_type":"primary","measure":"Breathing rate","time_frame":"Simultaneous measurement with the PAD-2A wrist cuff device from the start of cuff deflation to the end of cuff deflation (approximately 60 seconds).","description":"Standard clinical capnograph device via nasal cannula (breaths per minute)"},{"outcome_type":"primary","measure":"Breathing rate","time_frame":"Simultaneous measurement with the PAD-2A wrist cuff device from the start of cuff deflation to the end of cuff deflation (approximately 60 seconds).","description":"Standard clinical nasal pressure transducer via nasal cannula (breaths per minute)"},{"outcome_type":"primary","measure":"Breathing rate","time_frame":"Simultaneous measurement with the PAD-2A wrist cuff device from the start of cuff deflation to the end of cuff deflation (approximately 60 seconds).","description":"Standard clinical thermistor via nasal cannula (breaths per minute)"},{"outcome_type":"secondary","measure":"Breathing rate","time_frame":"Simultaneous measurement with the PAD-2A wrist cuff device from the start of cuff deflation to the end of cuff deflation (approximately 60 seconds).","description":"Standard clinical respiratory inductance plethysmography (RIP) belts (breaths per minute)"}]}
{"nct_id":"NCT04266457","start_date":"2021-09-01","enrollment":125,"brief_title":"Establishing Alpha-synuclein RT-QuIC Assay as a Diagnostic Technique in REM Sleep Behaviour Disorder","official_title":"Establishing Alpha-synuclein Real Time - Quaking Induced Conversion (RT-QuIC) Assay as a Diagnostic Technique in Rapid Eye Movement (REM) Sleep Behaviour Disorder (RBD)","primary_completion_date":"2022-09-01","study_type":"Observational","rec_status":"Suspended","completion_date":"2022-09-01","last_update":"2021-05-19","description":"We hypothesise that a real-time quaking induced conversion assay for the detection of pathological alpha-synuclein ( -syn RTQuIC) can be used to differentiate between cases of idiopathic REM-sleep behaviour disorder (RBD) and RBD that is symptomatic of prodromal -synucleinopathies.","other_id":"AC20015","observational_model":"Cohort","time_perspective":"Cross-Sectional","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"Patients diagnosed with REM Sleep Behavioural Disorder using ICSD-3 criteria","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients diagnosed with Rapid Eye Movement Behaviour Disorder (RBD) using the\r\n             International Classification of Sleep Disorders version 3 (ICSD-3) criteria [18] -\r\n             Patients aged 18 years and over - Patient able to give written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  RBD secondary to medication or withdrawal state. - <18 years old - Inability to give\r\n             written informed consent - Contraindication to lumbar puncture procedure (e.g.\r\n             patients taking Warfarin)\r\n      ","sponsor":"University of Edinburgh","sponsor_type":"Other","conditions":"Sleep Disorder Rem Sleep Behavior|Parkinson's Disease, Lewy Body","interventions":[{"intervention_type":"Other","name":"Other: No Intervention","description":"No Intervention"}],"outcomes":[{"outcome_type":"primary","measure":"Presence of pathological α-synuclein within the cerebrospinal fluid (CSF)","time_frame":"0-24 months after sample taken","description":"The primary outcome measure will be either a positive/negative (binary) result from the α-syn RT-QuIC assay. A positive output confirms presence of pathological α-synuclein within the CSF."}]}
{"nct_id":"NCT04864470","start_date":"2021-09-01","phase":"N/A","enrollment":122,"brief_title":"Stroke Odysseys: Evaluation of a Community-based Performance Arts Programme for People That Have Experienced Stroke","official_title":"Stroke Odysseys: Evaluation of a Community-based Performance Arts Programme for People That Have Experienced Stroke","primary_completion_date":"2022-09-01","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2022-09-01","last_update":"2021-04-29","description":"There are over 1.2 million stroke survivors in the UK and annual costs of stroke care to the NHS will treble from 3.4 billion in 2015 to 10.2 billion in 2035. More than 60% of stroke survivors leave hospital with a disability, and half experience depression within the first five years. Emotional, social and psychological needs are common, often compounded by patients' perceptions of 'abandonment' when rehabilitation ends. Currently there is a gap between the social, emotional and physical needs of stroke survivors and the availability and suitability of long-term recovery and rehabilitation services. In 2018, a commissioned survey by the Stroke Association found 50% of stroke survivors and 85% of carers felt they needed more support than currently exists. Stroke Odysseys - the performance art programme- provides an opportunity for communication of experiences of stroke to an audience through acquired skills in movement, music, song and the spoken word. The performance arts courses delivered by Rosetta Life for stroke survivors have been evaluated in previous studies and have shown that engagement in and learning about performance skills can have a positive impact on perceptions of disability, improve cognition, mobility and speech disabilities among a stroke community that can be stigmatised by the public perception of disabling illness. The Stroke Odysseys programme will be scaled up to a large number of participants with the aim to evaluate the experience, impact and implementation of the programme. This prospective study will evaluate the experience and impact of Stroke Odysseys on those participating using mixed methods (interviews, observations and surveys) prior to and after each stage of the programme, and carry out non-participant observations during a percentage of the workshops, training and tour. This trial will also examine how effectively the programme is implemented and the factors (facilitators or barriers) that affect its implementation (i.e. implementation effectiveness). This will help us to identify not just 'if' but also 'why' the programme works and support our understanding of how it can be successfully delivered and scaled up within clinical pathways. Within this, the researchers will also explore the cost effectiveness of the programme, including the cost of its delivery and the balance of the benefit for the health sector, in order to be able to develop strong business plan for its longer-term use and wider scale implementation.","other_id":"219425/Z/19/Z-SO","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  over 18 years of age\r\n\r\n          -  have had one or more stroke(s)\r\n\r\n          -  received inpatient care in a UK stroke care pathway and are able to follow a 2-stage\r\n             command and hold a conversation in English if no supporter/friend is available to\r\n             translate\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  any person with co-morbidities that would prevent participation in group activities\r\n             e.g. dementia or deteriorating or fluctuating palliative conditions\r\n\r\n          -  unable to understand English\r\n\r\n          -  unable to commit to the 12-week programme\r\n      ","sponsor":"King's College London","sponsor_type":"Other","conditions":"Stroke","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Stroke Odysseys","description":"The participants will take part in a twelve-week performance programme that takes place online/in a community halls/arts centre. Sessions run for three hours and during these sessions, participants devise a dance and music performance work from their own stories. The culmination of the programme will be a public facing performance to an audience of carers, health care practitioners, friends, family and the wider community, done online through Zoom.\r\nAfter the performance is completed, participants will be invited to a training programme where they learn to act as advocates for life after stroke - termed 'stroke ambassadors'. The training will be a four-day programme. The programme will take place once weekly and is led by a team of artists supported by a leadership coach, on Zoom.\r\nFollowing training, ambassadors will support artists in recruitment, befriend the newly discharged stroke survivors and take part in small scale performance tours to challenge the perception of disability."}],"outcomes":[{"outcome_type":"primary","measure":"To evaluate emotional wellbeing, participation and activity of stroke participants and any change pre and post SO programme using the Oxford Participation and Activities Questionnaire (OX-PAQ)","time_frame":"The primary clinical outcome measure is change in Ox-PAQ total score between baseline and Week 12 (end of workshop)","description":"To evaluate emotional wellbeing, participation and activity of stroke participants and any change pre and post intervention. using the Oxford Participation and Activities Questionnaire (OX-PAQ): The Oxford Participation and Activities Questionnaire is a short, 23-item, patient-reported outcome measure developed to assess participation and activity in patients experiencing a range of health conditions.."},{"outcome_type":"primary","measure":"To evaluate to what extent Stroke Odysseys is acceptable, to survivors and wider stakeholders using the Acceptability of Intervention Measure (AIM)","time_frame":"The AIM will be collected during the workshop (Week 6), after the workshop is completed (Week 12) and after stroke ambassador training (Week 16). Interviews will be conducted after the workshop (Week 12) and after stroke ambassador training (Week 16).","description":"The primary outcome implementation measure is acceptability as measured by the Acceptability of Intervention Measure (AIM) A 4-item measure of perceived intervention acceptability. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean."},{"outcome_type":"primary","measure":"To evaluate to what extent Stroke Odysseys is acceptable, to survivors and wider stakeholders using semi-structured interviews.","time_frame":"Interviews will be conducted after the workshop (Week 12) and after stroke ambassador training (Week 16).","description":"The primary outcome implementation measure is acceptability as measured by semi-structured interviews to explore reasons for acceptability."},{"outcome_type":"secondary","measure":"To study the context, mechanisms and interactions which take place during Stroke Odysseys delivery","time_frame":"During workshop delivery (Week 6)","description":"Non-participant observations of workshops"},{"outcome_type":"secondary","measure":"To explore learning and experiences of facilitators and participants","time_frame":"After the workshop is completed (Week 12)","description":"Semi-structured interviews (stroke participants and facilitators)"},{"outcome_type":"secondary","measure":"To explore stroke survivors' preparation and participation in performances","time_frame":"Baseline","description":"Semi structured interviews (stroke participants)"},{"outcome_type":"secondary","measure":"To evaluate to what extent Stroke Odysseys is appropriate to survivors and wider stakeholders","time_frame":"The IAM will be collected during the workshop (Week 6), after the workshop is completed (Week 12) and after stroke ambassador training (Week 16). Interviews will be conducted after the workshop (Week 12) and after stroke ambassador training (Week 16)..","description":"Intervention Appropriateness Measure (IAM) & Semi-structured interviews to explore reasons for appropriateness score.\r\nThe A 4-item measure of perceived intervention appropriateness. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean."},{"outcome_type":"secondary","measure":"To evaluate to what extent Stroke Odysseys feasible to survivors and wider stakeholders","time_frame":"The FIM will be collected during the workshop (Week 6), after the workshop is completed (Week 12) and after stroke ambassador training (Week 16). Interviews will be conducted after the workshop (Week 12) and after stroke ambassador training (Week 16).","description":"Feasibility Intervention Measure (FIM) & Semi-structured interviews to explore reasons for feasibility score The FIM is a 4-item instrument to assess perceived intervention feasibility. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean"},{"outcome_type":"secondary","measure":"To assess any unintended consequences of the programme","time_frame":"Interviews will be conducted after completion of the workshop (Week 12) and after completion of stroke ambassador training (Week 16).","description":"Semi-structured interviews"},{"outcome_type":"secondary","measure":"To explore the facilitators and barriers to implementing the programme","time_frame":"Interviews will be conducted after completion of the workshop (Week 12) and after completion of stroke ambassador training (Week 16).","description":"Semi-structured interviews"},{"outcome_type":"secondary","measure":"To explore the facilitators and barriers to sustained use of the programme","time_frame":"Interviews will be conducted after completion of the workshop (Week 12) and after completion of stroke ambassador training (Week 16).","description":"Semi-structured interviews"},{"outcome_type":"secondary","measure":"To assess service utilisation and cost associated costs and changes in quality of life associated with the implementation of the programme","time_frame":"These measures will be collected after completion of the workshop (Week 12) and after completion of stroke ambassador training (Week 16).","description":"EQ5D-5L (quality of life measure) and AD-SUS (adult service receipt schedule) and semi structured interviews and activity data (to estimate implementation costs).\r\nThe EQ5D-5L is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.\r\nThe AD-SUS measures the use of adult health services."},{"outcome_type":"secondary","measure":"To explore the strategies including resource inputs utilised, used within individual sites to implement the programme","time_frame":"Interviews will be conducted after completion of the workshop (Week 12) and after completion of stroke ambassador training (Week 16).","description":"Semi-structured interviews"},{"outcome_type":"secondary","measure":"To assess the adoption of the programme","time_frame":"This will be measured at baseline, after completion of the workshop (Week 12) and after completion of stroke ambassador training (Week 16).","description":"Count the number of individuals delivering the programme, and the number of individuals supporting the programme (and continuing to do so)"},{"outcome_type":"secondary","measure":"To assess programme adherence and attrition rates","time_frame":"Data recorded from register on weekly attendance rates for 12-week programme (stage 1) and for 4-week ambassador programme (stage 2)","description":"Data on the overall adherence to the programme, number of drops-outs and reasons why"}]}
{"nct_id":"NCT04943484","start_date":"2021-09-01","enrollment":360,"brief_title":"ICG (Indocyanine Green) Imaging Fluorescence Technology in Surgical Treatment of Advanced Gastric Cancer","official_title":"[The iGreenGO Study]. Investigation About the Clinical Value of Indocyanine Green Imaging Fluorescence (NIR/ICG) Technology as a Modifier of Surgeon's Conduct During Curative Treatment of Advanced Gastric Cancer. Study Protocol for a Western, Observational, Prospective, Multicentric Study","primary_completion_date":"2024-08-31","study_type":"Observational","rec_status":"Not yet recruiting","completion_date":"2024-11-30","last_update":"2021-06-29","description":"The aim of the iGreenGO Study is to investigate whether the intraoperative application of NIR/ICG technology is associated with a change of the surgical conduct (CSC) during curative-intent gastrectomy with D2 lymphadenectomy in a cohort of western patients affected by gastric cancer. The patterns of ICG fluorescence distribution to the abdominal lymph node stations were also investigated, together with identification of preoperative clinical variables potentially associated with CSC.","other_id":"380-09062021","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Male and female subjects, over 18 years of age, with histological diagnosis of locally\r\n        advanced gastric carcinoma (AGC), surgically resectable, without evidence of distant\r\n        metastases (cT2-T4a; N0-3; M0) for which a surgical intervention with curative purposes is\r\n        indicated both as a first treatment and following preoperative neoadjuvant chemotherapy","criteria":"\n        Inclusion criteria\r\n\r\n          -  Age  18 years old\r\n\r\n          -  Preoperative histologically proven adenocarcinoma of the upper, middle or lower part\r\n             of the stomach.\r\n\r\n          -  Advanced disease (Staged cT2-T4a, N0-3;M0 according to 8th edition of the AJCC TNM\r\n             Staging System) at diagnosis, in which resection can be safely achieved by distal or\r\n             total gastrectomy with D2 lymphadenectomy, either as first treatment or after\r\n             preoperative neoadjuvant treatment.\r\n\r\n          -  No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby\r\n             in the preoperative and intraoperative examinations\r\n\r\n          -  Written informed consent\r\n\r\n        Exclusion criteria\r\n\r\n          -  Women during pregnancy or breast-feeding\r\n\r\n          -  History of previous upper abdominal surgery (laparoscopic cholecystectomy will be\r\n             allowed)\r\n\r\n          -  History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal\r\n             dissection\r\n\r\n          -  History of allergy to iodine agents\r\n\r\n          -  Cancer located at the esophago-gastric junction (Siewert I, II, III tumors 29)\r\n\r\n          -  Patients candidates to transthoracic esophagectomy, transhiatal extended gastrectomy\r\n             or proximal gastrectomy\r\n\r\n          -  History of previous neoadjuvant chemotherapy (except perioperative chemotherapy for\r\n             gastric cancer) or radiotherapy\r\n      ","sponsor":"Niguarda Hospital","sponsor_type":"Other","conditions":"Gastric Cancer","interventions":[{"intervention_type":"Procedure","name":"Procedure: imaging fluorescence NIR/ICG","description":"Preoperative upper GI endoscopy (UGE) UGE with submucosal injection of 2ml of ICG 0.125mg/ml solution to four peritumoral sites 15-20 hours before surgery Surgery D2 Distal gastrectomy with dissection of 1, 3, 4sb, 4sd, 5, 6, 7, 8a, 9, 11p, 12a lymph node stations (LNS) D2 Total gastrectomy with dissection of 1, 2, 3, 4sa, 4sb, 4d, 5, 6, 7, 8a, 9, 11p, 11d, 12a LNS Intraoperative NIR/ICG technology, \"change of surgical conduct\" (CSC) A visualization of the operative field (OF) with NIR/ICG technology is performed at the beginning of surgery and before to dissect each LNS. Subsequently, surgery is performed \"with the naked eye\".\r\nAt the end, a visualization of the OF is performed using NIR/ICG technology to verify whether residual lymph nodes in each D2 nodal station exist. CSC is defined as the occurring of the following situation: in case of persistence of nodal fluorescence in D2 nodal stations, the completion of the dissection of the residual nodal fluorescent structures."}],"outcomes":[{"outcome_type":"primary","measure":"Surgical conduct","time_frame":"During surgical intervention (hours)","description":"Incidence of \"change of the surgical conduct\" (CSC) at the moment of intraoperative NIR/ICG technology activation after a D2 lymphadenectomy performed \"with the naked eye\""},{"outcome_type":"secondary","measure":"Nodal fluorescence distribution","time_frame":"During surgical intervention (hours)","description":"Pattern of nodal fluorescence distribution according to tumor and patient characteristics"},{"outcome_type":"secondary","measure":"Clinical variables associated with change of the surgical conduct","time_frame":"During surgical intervention (hours)","description":"Identification of preoperative clinical variables potentially associated with change of the surgical conduct"}]}
{"nct_id":"NCT04084574","start_date":"2021-09-01","phase":"N/A","enrollment":50,"brief_title":"Diet and Hypertension Management in African Americans With Chronic Kidney Disease","official_title":"Diet and Hypertension Management in African Americans With Chronic Kidney Disease","primary_completion_date":"2024-08-30","study_type":"Interventional","rec_status":"Suspended","completion_date":"2024-08-30","last_update":"2021-05-24","description":"The purpose of this study is to determine cultural and disease-related barriers and facilitators to following the Dietary Approaches to Stop Hypertension (DASH) dietary pattern among Black Americans with moderate chronic kidney disease (CKD) and test the impact of a behavioral diet counseling intervention on DASH diet adherence, blood pressure, and CKD-relevant outcomes.","other_id":"Pro00102823","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":21,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Black race (self-identified)\r\n\r\n          -  21 years old\r\n\r\n          -  CKD defined as an eGFR of 30-59 ml/min/1.73m2\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of kidney transplant\r\n\r\n          -  Pregnant of breast-feeding\r\n\r\n          -  Risk factors for hyperkalemia including insulin-dependent diabetes mellitus, diabetes\r\n             with poor blood glucose control (A1C >10), baseline serum potassium 4.8 mg/dl, and\r\n             serum bicarbonate <18 mg/dl\r\n\r\n          -  History of hypertension in the preceding 6 months defined as serum potassium greater\r\n             than 5.1 mg/dl\r\n\r\n          -  Risk for hypotension or severe hypertension (SBP <120 or 180 or DBP 110 mmHg)\r\n\r\n          -  History of kidney transplant\r\n\r\n          -  Lack of English language proficiency\r\n      ","sponsor":"Duke University","sponsor_type":"Other","conditions":"Chronic Kidney Diseases|High Blood Pressure","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: DASH diet counseling","description":"Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants who complete the 12 week intervention program","time_frame":"Up to 12 weeks","description":"Completion will be measured by the number of group counseling sessions attended by participants randomized to the treatment arm."},{"outcome_type":"primary","measure":"Number of participants who complete data collection visits","time_frame":"Up to 6 months","description":"Completion will be measured by the number of randomized participants who provide blood and urine biospecimens, clinic and 24-hour ambulatory blood pressure measurements, and 24-hour dietary recall data during scheduled data collection visits at baseline, 1 month, 3 months, and 6 months."},{"outcome_type":"primary","measure":"Change in 24-hour mean systolic blood pressure during treatment","time_frame":"Baseline to 12 weeks","description":"Change will be measured by comparing the 24-hr mean systolic blood pressures (mmHg) obtained at baseline and at 12 weeks (end of treatment.)"},{"outcome_type":"primary","measure":"Change in serum potassium concentration during treatment","time_frame":"Baseline to 12 weeks","description":"Change will measured by comparing serum potassium concentration levels obtained at baseline and at 12 weeks (end of treatment.)"},{"outcome_type":"primary","measure":"Change in 24 hour urine concentrations of sodium during treatment","time_frame":"Baseline to 12 weeks","description":"Change will be measured by comparing sodium concentration levels (mmol/24 hr) obtained from 24 hour urine samples collected at baseline and 12 weeks (end of treatment.)"},{"outcome_type":"primary","measure":"Change in 24 hour urine concentrations of potassium during treatment","time_frame":"Baseline to 12 weeks","description":"Change will be measured by comparing potassium concentration levels (mmol/24 hr) obtained from 24 hour urine samples collected at baseline and 12 weeks (end of treatment.)"},{"outcome_type":"primary","measure":"Change in 24 hour urine concentrations of phosphorus during treatment","time_frame":"Baseline to 12 weeks","description":"Change will be measured by comparing phosphorus concentration levels (mg/24 hr) obtained from 24 hour urine samples collected at baseline and 12 weeks (end of treatment.)"},{"outcome_type":"primary","measure":"Change in 24 hour urine concentrations of urea nitrogen during treatment","time_frame":"Baseline to 12 weeks","description":"Change will be measured by comparing phosphorus concentration levels (g/24 hr) obtained from 24 hour urine samples collected at baseline and 12 weeks (end of treatment.)"},{"outcome_type":"secondary","measure":"Change in clinic systolic blood pressure during treatment","time_frame":"Baseline to 12 weeks","description":"Change will be measured by comparing clinic systolic blood pressures (mgHH) obtained at baseline and at 12 weeks (end of treatment.)"},{"outcome_type":"secondary","measure":"Change in body weight during treatment","time_frame":"Baseline to 12 weeks","description":"Change will be measured by comparing body weights (kg.) obtained at baseline and at 12 weeks (end of treatment.)"},{"outcome_type":"secondary","measure":"Change in 24-hour mean systolic blood pressure 3-months post-treatment.","time_frame":"12 weeks to 24 weeks","description":"Change will be measured by comparing the 24-hour mean systolic blood pressures (mmHg) obtained at 12 weeks (end of treatment) and at 24 weeks (3-months post-treatment.)"},{"outcome_type":"secondary","measure":"Change in body weight 3 months after intervention","time_frame":"12 weeks to 24 weeks","description":"Change will be measured by comparing body weights (kg.) obtained at 12 weeks (end of treatment) and at 24 weeks (3-months post-treatment.)"},{"outcome_type":"secondary","measure":"Number of participants who sustained their end of treatment DASH diet adherence scores for 3 months after intervention.","time_frame":"12 weeks to 24 weeks","description":"Sustained DASH diet scores will be measured by comparing scores derived from 24-hour dietary recall data obtained at 12 weeks (end of treatment) and at 24 weeks (3-months post-treatment.)"}]}
{"nct_id":"NCT04992975","start_date":"2021-08-31","enrollment":40,"brief_title":"Brain Iron Toxicity and Neurodegeneration - A 7T MRI Study","official_title":"Brain Iron Toxicity and Neurodegeneration - An Ultrahigh Field (7T) MRI Study","primary_completion_date":"2023-01-31","study_type":"Observational","rec_status":"Enrolling by invitation","completion_date":"2023-09-30","last_update":"2021-08-06","description":"A longitudinal observational neuroimaging study of individuals with Early Onset Alzheimer's disease during the prodromal phase, and matched control group - Ultrahigh Field MRI study at 7T","other_id":"19NS038","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":75,"population":"Alzheimer's Group: Preclinical or Prodromal Alzheimer's disease classified as either A+T-N-\r\n        or A+T+N- Control Group: individual within 1.5 standard deviation of normal cognition in\r\n        all tests","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Ability to provide informed consent\r\n\r\n          -  Patients with pathological diagnosis of Alzheimer's disease according to the National\r\n             Institute on Aging and Alzheimer's Association, NIA-AA, criteria (Alzheimer's group)\r\n             or cognitively normal individuals within 1.5 standard deviation of normal in all tests\r\n             (control group)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Lack of mental capacity to consent to study involvement\r\n\r\n          -  Not speaking English before age 5 years\r\n\r\n          -  Learning disability\r\n\r\n          -  Schizophrenia\r\n\r\n          -  Substance misuse\r\n\r\n          -  Implanted devices not certified as compatible with ultra-high field MRI (e.g. cardiac\r\n             pacemaker)\r\n\r\n          -  Pregnancy\r\n      ","sponsor":"Nottingham University Hospitals NHS Trust","sponsor_type":"Other","conditions":"Prodromal Alzheimer's Disease|Mild Cognitive Impairment","interventions":[{"intervention_type":"Other","name":"Other: MRI at 7T","description":"MRI at 7T"}],"outcomes":[{"outcome_type":"primary","measure":"Quantitative Susceptibility Mapping, QSM (from 7T MRI data) to hippocampal subfield volume loss at 1 year","time_frame":"one year","description":"Relationship between QSM at recruitment and to hippocampal subfield volume (QSM and hippocampal subfield volume are obtained from 7T MRI Susceptibility Weighted and T1 Weighted images)"},{"outcome_type":"secondary","measure":"cross-sectional and longitudinal changes in QSM in the hippocampal subfields","time_frame":"one year","description":"cross-sectional and longitudinal changes in QSM in the local hippocampal subfield QSM and volume loss after 1 year. QSM and hippocampal subfields volume will be obtained from 7T MRI data"},{"outcome_type":"secondary","measure":"neuropsychological measures in relation to QSM and volume loss in hippocampal subfields","time_frame":"one year","description":"neuropsychological measures at 0 and 12 months in relation to QSM and volume loss in hippocampal subfields (adjusted for APOe). QSM and hippocampal subfield volume loss are obtained from 7T MRI Susceptibility Weighted and T1 Weighted images."}]}
{"nct_id":"NCT04956744","start_date":"2021-08-31","phase":"Phase 1","enrollment":30,"brief_title":"A Study to Evaluate the Safety, Tolerability, and Exploratory Efficacy of IMS001 in Subjects With Multiple Sclerosis","official_title":"A Phase 1, Dose-Escalating, Open-label Study to Evaluate the Safety, Tolerability, and Exploratory Efficacy of Single Dose of IV IMS001 in Subjects With Multiple Sclerosis and Treatment Failure to Prior Disease Modifying Treatments (DMTs)","primary_completion_date":"2027-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2027-12-31","last_update":"2021-09-21","description":"This is a Phase 1 study of IMS001, given as a single dose to subjects with Multiple Sclerosis who experience inadequate response and/or intolerability to disease modifying treatments. IMS001 is a human embryonic cell derived (hESC) mesenchymal stem cell (MSC). MSCs have the potential to modulate disease course.","other_id":"IMS001-01","allocation":"Non-Randomized","intervention_model":"Sequential Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Provides signed and dated informed consent in accordance with local regulations.\r\n\r\n          -  18 to 65 years of age.\r\n\r\n          -  Diagnosis of MS.\r\n\r\n          -  Has had an inadequate response DMTs.\r\n\r\n          -  EDSS within protocol parameters.\r\n\r\n          -  Able and willing to undergo MRIs.\r\n\r\n          -  Must be clinically stable for 1 month prior to Day 1.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Has a known or suspected hypersensitivity to human serum albumin, diphenhydramine,\r\n             acetaminophen, methylprednisolone, or any of the components of IMS001.\r\n\r\n          -  Has history of excluded medications, per protocol, prior to Day 1.\r\n\r\n          -  Has a history of neoplastic disease except for basal cell carcinoma, non-metastatic\r\n             squamous cell carcinoma of the skin that has been excised with clean margins, or\r\n             adequately treated in-situ carcinoma of the cervix.\r\n\r\n          -  Prior history of any other autoimmune disease, myelodysplasia, or hematologic disease.\r\n\r\n          -  Prior treatment with any allogeneic cell therapy or tissue transplant.\r\n\r\n          -  Prior history of smoking equivalent to 20 cumulative pack years of cigarettes.\r\n\r\n          -  Recent clinically significant infection during the Screening Phase.\r\n\r\n          -  Has any medical or psychiatric condition that would impact outcome or participation in\r\n             the study.\r\n\r\n          -  Has clinically significant abnormal findings on the electrocardiogram (ECG) during the\r\n             Screening Phase.\r\n\r\n          -  Has known or documented human immunodeficiency virus (HIV) infection or active\r\n             Hepatitis B, or C.\r\n\r\n          -  Has an elevated liver function test abnormality during the Screening Phase.\r\n\r\n          -  Has abnormalities of blood count during the Screening Phase.\r\n\r\n          -  Has laboratory abnormalities of renal function during the Screening Phase.\r\n\r\n          -  Has other clinically significant laboratory abnormalities during Screening Phase.\r\n\r\n          -  Body weight 120 kg.\r\n\r\n          -  Women pregnant, breast feeding, or planning to become pregnant during the study.\r\n\r\n          -  Is unavailable for the duration of the trial, is likely to be noncompliant with the\r\n             protocol, or is generally felt to be unsuitable by the principal investigator.\r\n\r\n          -  Current or recent participation in any other clinical or device trials within 3 months\r\n             prior to Day 1.\r\n      ","sponsor":"ImStem Biotechnology","sponsor_type":"Industry","conditions":"Multiple Sclerosis","interventions":[{"intervention_type":"Biological","name":"Biological: IMS001","description":"IMS001 is a human embryonic cell derived (hESC) mesenchymal stem cell (MSC)."}],"outcomes":[{"outcome_type":"primary","measure":"Safety and tolerability","time_frame":"Day 1 to Month 60","description":"Frequency of treatment-emergent adverse events (TEAEs)."},{"outcome_type":"primary","measure":"Safety and tolerability","time_frame":"Day 1 to Month 60","description":"Clinically significant laboratory abnormalities."}]}
{"nct_id":"NCT04920253","start_date":"2021-08-31","phase":"N/A","enrollment":180,"brief_title":"Real World Evidence With the Debritom+ TM Novel Micro Water Jet Technology at a Single Wound Center","official_title":"Real World Evidence With the Debritom+ TM Novel Micro Water Jet Technology at a Single Wound Center","primary_completion_date":"2023-09-30","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2023-09-30","last_update":"2021-06-11","description":"Prospective, single-blinded, single-center, parallel group, randomized controlled trial (RCT) to assess rate and frequency of wound healing, and associated financial savings, when using Medaxis debritom+ versus standard of care as a choice of debridement method, where both arms follow normal wound care practice in use of advanced wound care treatments.","other_id":"MEDX-DT-03","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","intervention_model_description":"Prospective, single-blinded, single-center, parallel group, randomized controlled trial (RCT). Control and Treatment Arms","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        General\r\n\r\n        Potential subjects are required to meet all of the following criteria for enrollment into\r\n        the study and subsequent randomization:\r\n\r\n          1. At least 18 years old.\r\n\r\n          2. The index wound (i.e. current episode of the wound or ulcer) has been present for\r\n             greater than 4 weeks prior to SV 1 and less than 1 year, as of the subject's consent\r\n             for the study participation.\r\n\r\n          3. The index wound is a minimum of 1.0 cm2 and a maximum of 25 cm2 at SV1.\r\n\r\n          4. Subject understands and is willing to participate in the clinical study and can comply\r\n             with weekly visits.\r\n\r\n          5. Subject must have read and signed the IRB approved Informed Consent Form (ICF) before\r\n             study specific screening procedures that are not standard of care are undertaken.\r\n\r\n             DFU\r\n\r\n          6. Presence of diabetic foot ulcer (DFU) that meets all of the following features:\r\n\r\n             a. Wagner Grade 1 or 2 (see Appendix A for definitions), including wounds that extend\r\n             to the ligament, tendon, joint capsule or fascia\r\n\r\n          7. Without abscess or osteomyelitis\r\n\r\n               1. The index ulcer will be the largest ulcer if two or more DFUs are present and\r\n                  will be the only one evaluated in the study. If other ulcerations are present on\r\n                  the same foot, they must be more than 2cm distant from index ulcer (edge to\r\n                  edge).\r\n\r\n               2. The index ulcer has been offloaded for at least 14 days prior to randomization\r\n\r\n               3. Adequate circulation to the affected foot as documented by a Clarifi SFDI\r\n                  Vascular Assessment Tool, or an Ankle Brachial Index (ABI) between 0.7 and 1.3\r\n                  within 3 months of SV1, using the affected study extremity. As an alternative,\r\n                  arterial Doppler ultrasound can be performed, evaluating for bi-phasic dorsalis\r\n                  pedis and posterior tibial vessels at the level of the ankle within 3 months of\r\n                  SV1 or if monophasic wave forms present must have adequate micro circulation as\r\n                  evidenced by Clarifi SFDI Vascular Assessment Tool. Note: A documented record of\r\n                  an ABI test performed using the index ulcer leg, within 3 months of SV1 is\r\n                  acceptable for the purposes of this study. Otherwise, this must be completed in\r\n                  the Screening Visit. Acceptable alternatives include arterial Doppler ultrasound\r\n                  evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level\r\n                  of the ankle, or documented adequate microcirculation as determined by a Clarifi\r\n                  SFDI Vascular Assessment Tool.\r\n\r\n             VLU\r\n\r\n          8. All wounds using the CEAP VLU Classification, except for those in the exclusion\r\n             criteria. (See Appendix A for definitions)\r\n\r\n          9. The index ulcer will be the largest ulcer if two or more VLUs are present and will be\r\n             the only one evaluated in the study. If other Ulcerations are present on the same leg,\r\n             they must be more than 2cm distant from index ulcer.\r\n\r\n             Surgical Dehisced\r\n\r\n         10. All wounds using the Sandy Grading System, except those in the exclusion criteria.\r\n             (See Appendix A for definitions) Traumatic\r\n\r\n         11. All wounds as per the CDC Surgical Wound Classification, with the exception of Class\r\n             IV or dirty infected wounds, SSI - Deep incisional and organ space. (See Appendix A\r\n             for definitions)\r\n\r\n        Exclusion Criteria:\r\n\r\n        General\r\n\r\n        Potential subjects meeting any of the following criteria will be excluded from enrollment\r\n        and subsequent randomization:\r\n\r\n          1. The index wound, in the opinion of the investigator, is suspicious for cancer or have\r\n             a positive carcinoma diagnosis.\r\n\r\n          2. Subject has a history of more than two weeks of treatment with immune-suppressants\r\n             (including systemic corticosteroids >10mg daily dose), cytotoxic chemotherapy, or\r\n             application of topical steroids to the wound surface within 1 month prior to first\r\n             SV1, or who receive such medications during the screening period or who are\r\n             anticipated to require such medications during the course of the study.\r\n\r\n          3. Subject is taking a selective COX-2 inhibitor, such as Celecoxib, for any condition.\r\n\r\n          4. Subject is on any investigational drug(s) or therapeutic device(s) within 30 days\r\n             preceding SV1.\r\n\r\n          5. History of radiation at the wound site (regardless of time since last radiation\r\n             treatment).\r\n\r\n          6. Index wound has been previously treated or will need to be treated with any prohibited\r\n             therapies (See Section 6 of this protocol for a list of prohibited medications and\r\n             therapies).\r\n\r\n          7. Subject has a previous diagnosis of HIV, Hepatitis C, or other contagious diseases.\r\n\r\n          8. Presence of any condition(s) which seriously compromises the subject's ability to\r\n             complete this study or the subject has a known history of poor adherence with medical\r\n             treatment.\r\n\r\n          9. Subject is pregnant or breast-feeding.\r\n\r\n         10. Presence of diabetes with poor metabolic control as documented with an HbA1c >12.0 %\r\n             within 90 days of randomization.\r\n\r\n         11. Subject has end-stage renal disease as evidenced by a serum creatinine > 3.0mg/dL\r\n             within 6 months of randomization.\r\n\r\n         12. BMI >40 DFU\r\n\r\n         13. Wagner 2 wounds that require debridement of bone.\r\n\r\n         14. Osteomyelitis or bone infection of the affected foot as verified by x-ray, CAT Scan,\r\n             or MRI within 30 days prior to randomization (In the event of an ambiguous diagnosis,\r\n             the Principal Investigator will make the final decision).\r\n\r\n             VLU\r\n\r\n         15. Exclude\r\n\r\n               1. Secondary post thrombotic\r\n\r\n               2. Venous Obstruction\r\n\r\n               3. Venous Obstruction with reflux\r\n\r\n               4. Lipodermato sclerosis or atrophic blanche\r\n\r\n         16. Osteomyelitis or bone infection of the affected leg as verified by x-ray, CAT Scan, or\r\n             MRI within 30 days prior to randomization (In the event of an ambiguous diagnosis, the\r\n             Principal Investigator will make the final decision).\r\n\r\n             Surgical Dehisced\r\n\r\n         17. Using the Sandy Grading System for Surgical Wound Dehiscence: Wounds Grade 3 where\r\n             organs are exposed, and 3a, where the infection is severe as deemed by the Principal\r\n             Investigator.\r\n\r\n             Traumatic\r\n\r\n         18. Using CDC Surgical Wound Classification, exclude\r\n\r\n               1. Class IV - dirty infected wounds\r\n\r\n               2. SSI - Deep incisional and organ space\r\n      ","sponsor":"Medaxis, LLC","sponsor_type":"Industry","conditions":"Diabetic Foot Ulcer|Venous Leg Ulcer|Surgical Wound Dehiscence|Traumatic Wounds","interventions":[{"intervention_type":"Device","name":"Device: Study Device Debridement","description":"debritom+ water jet debridement"},{"intervention_type":"Device","name":"Device: SOC Debridement","description":"Sharp Scalpel"}],"outcomes":[{"outcome_type":"primary","measure":"Wound Closure","time_frame":"20 weeks","description":"Time to heal"},{"outcome_type":"secondary","measure":"Complications","time_frame":"20 weeks","description":"Incidence of all index wound-related complications (eg. cellulitis or Infection), hospitalization, wound recurrence"},{"outcome_type":"secondary","measure":"Advanced Wound Care Treatments","time_frame":"20 weeks","description":"Number of successful advanced wound care treatments placed (eg. Negative Pressure Wound Therapy /grafts)"},{"outcome_type":"secondary","measure":"Cost","time_frame":"20 weeks","description":"Cost of Treatment (including Advance Wound Care) and including any index wound-related, event-driven complications using patient records or Medicare reimbursement method."},{"outcome_type":"secondary","measure":"Healed Proportion","time_frame":"20 weeks","description":"Proportion of wounds completely healed"},{"outcome_type":"other","measure":"Unhealed Proportion","time_frame":"20 weeks","description":"Proportion of wounds not completely healed"},{"outcome_type":"other","measure":"PAR","time_frame":"20 weeks","description":"Percent Area Reduction of Wound"},{"outcome_type":"other","measure":"AWC Failure","time_frame":"20 weeks","description":"Number of failures in regard to advanced wound care treatments"}]}
{"nct_id":"NCT04949854","start_date":"2021-08-31","phase":"N/A","enrollment":360,"brief_title":"Evaluating the Role of the Guidewire in Peripheral Intravenous Access","official_title":"Evaluating the Role of the Guidewire in Peripheral Intravenous Access: A Randomized Controlled Trial of Ultrasound-Guided Catheter Survival","primary_completion_date":"2022-08-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2023-08-31","last_update":"2021-07-02","description":"This study is to demonstrate that the control ultralong intravenous catheter without the guide wire is equivalent to the experimental catheter with the guide wire. The hypothesis of this study is that the 6.35 cm 20G ultralong Ultrasound Guided Peripheral Intravenous (USPIV) will have no difference in survival compared to the 5.71 cm ultralong with wire USPIV.","other_id":"2021-049","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","intervention_model_description":"This is a prospective, parallel, non-blinded, two-arm randomized (like the flip of a coin) controlled trial of catheter failure evaluating the impact of a built-in guide wire. This study plans to enroll 360 participants (two equally sized groups of 180 participants in each arm).","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Eligible patients must be:\r\n\r\n          1.  than 18 years old\r\n\r\n          2. History of difficult access (at least one of the following):\r\n\r\n               1. Pt. recounts a prior visit/hospitalization when > 2 sticks required to obtain\r\n                  access\r\n\r\n               2. History of a rescue catheter (such as US-guided IV, PICC line, midline, or CVC)\r\n\r\n               3. ESRD on dialysis\r\n\r\n               4. History of IV Drug Use\r\n\r\n               5. History of Sickle Cell\r\n\r\n          3. No palpable or visible (< 2 mm) superficial veins\r\n\r\n        Clinicians Eligibility Criteria:\r\n\r\n          1. Clinician working in the emergency room (physician, advanced practice provider, nurse,\r\n             technician) OR clinician working on the inpatient vascular access team (advanced\r\n             practice provider, nurse)\r\n\r\n          2. Greater than 6 months experience in ultrasound guided IV insertions\r\n\r\n        Patients are excluded:\r\n\r\n          1. <18 years old\r\n\r\n          2. Restricted mobility of elbow joint\r\n      ","sponsor":"William Beaumont Hospitals","sponsor_type":"Other","conditions":"Peripheral Intravenous Vein Catheter Phlebitis|Intravenous Infection","interventions":[{"intervention_type":"Device","name":"Device: B.Braun 6.35 cm 20 Gauge ultralong intravenous catheter","description":"control Arm 1 (6.35 cm 20 Gauge ultralong intravenous catheter without guidewire"},{"intervention_type":"Device","name":"Device: B.D Accucath 5.71 cm 20 Gauge ultralong intravenous catheter","description":"Experimental Arm B.D Accucath 5.71 cm 20 Gauge ultralong intravenous catheter with guide wire"}],"outcomes":[{"outcome_type":"primary","measure":"Catheter survival","time_frame":"During hospitalization, up to 60 days","description":"Survival in hours or days of the catheter will be evaluated by functionality of catheter for intravenous therapy prior to patient discharge. The event of interest is failure of functionality identified during follow-up assessment during hospitalization."},{"outcome_type":"secondary","measure":"First-stick success.","time_frame":"First day of hospitalization","description":"Number of patients with only one puncture of skin to achieve venous access"},{"outcome_type":"secondary","measure":"Time to insertion","time_frame":"First day of hospitalization","description":"Time to insertion (measured in minutes) is defined as needlestick to dressing application."},{"outcome_type":"secondary","measure":"Provider proficiency","time_frame":"Study period, a maximum of 1 year","description":"Change in mean number of attempts per patient for successful insertion, from baseline mean for first three patients attempted to last three patients attempted."},{"outcome_type":"secondary","measure":"Total cost for all vascular access needs during hospitalization.","time_frame":"During hospitalization, up to 60 days","description":"Cost per patient for vascular access during hospitalization, comprising (i) direct costs of IV insertion based on estimated labor and material cost per insertion attempt and estimated similar costs for rescue devices if needed and (ii) cost of treatment based on estimated cost per hour."},{"outcome_type":"secondary","measure":"Catheter-associated thrombosis","time_frame":"During hospitalization, up to 60 days","description":"The number of patients with all symptomatic catheter related upper extremity venous thrombosis inclusive of superficial thrombophlebitis (SVT), deep venous thrombosis(DVT), and pulmonary embolism will be confirmed by upper extremity doppler evaluation, computed tomography, and/or ventilation perfusion testing."},{"outcome_type":"secondary","measure":"Catheter-associated bloodstream infection","time_frame":"During hospitalization, up to 60 days","description":"The number of patients with catheter-associated bloodstream infection. Cases of infection will be diagnosed per laboratory confirmed bloodstream infection criteria published by the National Healthcare Safety Network (NHSN) and identified by the Department of Epidemiology at Beaumont Hospital."},{"outcome_type":"secondary","measure":"Inflammatory complications by clinical assessment","time_frame":"During hospitalization, up to 60 days","description":"Number of patients with inflammatory complications measured by a score of 2 or greater on a standardized visual phlebitis scale, with a range of 0 to 5 where 0 is no inflammation and 5 is advanced stage thrombophlebitis."},{"outcome_type":"secondary","measure":"Inflammatory complications by ultrasound assessment","time_frame":"During hospitalization, up to 60 days","description":"Number of patients with inflammatory complications measured by presence of subcutaneous edema on ultrasound."}]}
{"nct_id":"NCT04898348","start_date":"2021-08-31","phase":"Phase 2","enrollment":30,"brief_title":"A Study to Investigate Efficacy and Safety of KBL697 in Patients With Mild to Moderate Active Ulcerative Colitis","official_title":"A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of KBL697 in Patients With Mild to Moderate Active Ulcerative Colitis","primary_completion_date":"2022-08-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2022-09-30","last_update":"2021-05-26","description":"The study is designed to investigate efficacy and safety of KBL697 in patients with mild to moderate active ulcerative colitis. KBL697 has been developed as a potential new treatment for ulcerative colitis.","other_id":"KBL-CURE-2020-03","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patient has an established diagnosis of ulcerative colitis for at least 3 months prior\r\n             to Screening\r\n\r\n          -  Patient has active mild to moderate ulcerative colitis at Visit 2\r\n\r\n          -  Patient is taking at least one of the following oral medication: 5-ASA,\r\n             Corticosteroids, Immunomodulators\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patient has a possible or confirmed diagnosis of Crohn's Disease or other forms of\r\n             inflammatory bowel disorders\r\n\r\n          -  Patient has a persistent fever of  38.3C\r\n\r\n          -  Patient has current signs or symptoms of infection\r\n\r\n          -  Patient has any immunosuppressant condition\r\n\r\n          -  Patient has a known malignancy within 5 years prior to Screening\r\n\r\n          -  Patient has a known allergy or intolerance to vancomycin\r\n\r\n          -  Patient has any contraindication for use of vancomycin\r\n\r\n          -  Patient who has a medical history of drug abuse or alcohol abuse\r\n\r\n          -  Patient who, in the opinion of the Investigator, has a clinically significant\r\n             co-morbid disease\r\n\r\n          -  Patient has hepatic failure\r\n\r\n          -  Patient is pregnant or plans a pregnancy within the study period\r\n\r\n          -  Patient has no previous history of treatment for ulcerative colitis (treatment-nave\r\n             patient)\r\n\r\n          -  Patient has ongoing or failed treatment for ulcerative colitis with calcineurin\r\n             inhibitor\r\n\r\n          -  Patient has received biologic medication\r\n\r\n          -  Patient has received antibiotics within 4 weeks prior to Visit 2\r\n\r\n          -  Patient is unable to stop previous antibiotics treatment during study period\r\n\r\n          -  Patient has received probiotics within 2 weeks prior to Visit 2\r\n\r\n          -  Patient with history of major surgery in any region of the gastrointestinal tract\r\n\r\n          -  Patient has received any investigational product or participated in another clinical\r\n             trial\r\n\r\n          -  Patient has a stool culture or other examination positive for an enteric pathogen\r\n\r\n          -  Patient tests positive for CMV by PCR test at Screening\r\n\r\n          -  Patient tests positive for HIV at Screening\r\n\r\n          -  Exclusion criteria based on results of Hepatitis B at Screening\r\n\r\n          -  Exclusion criteria based on results of Hepatitis C at Screening\r\n      ","sponsor":"KoBioLabs","sponsor_type":"Industry","conditions":"Ulcerative Colitis","interventions":[{"intervention_type":"Drug","name":"Drug: Vancomycin Pre-Treatment","description":"Four times per day dosing of Vancomycin pre-treatment"},{"intervention_type":"Drug","name":"Drug: KBL697","description":"3 capsules twice a day dosing of KBL697"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"3 capsules twice a day dosing of Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"Proportion of Patients with Clinical Remission","time_frame":"Week 9","description":"Proportion of Patients with Clinical Remission at Week 9"},{"outcome_type":"secondary","measure":"Change from baseline in Partial Mayo Score","time_frame":"Week 9","description":"Change from baseline in Partial Mayo Score at Week 9 Minimum value: 0, Maximum value: 9, higher score mean a worse outcome"},{"outcome_type":"secondary","measure":"Portion of patients with Endoscopic subscore change","time_frame":"Week 9","description":"Portion of patients with endoscopic subscore decrease to ≥ 1 at Week 9"},{"outcome_type":"secondary","measure":"Change from baseline in C-reactive Protein","time_frame":"Week 9","description":"Change from baseline in concentration of C-reactive Protein"},{"outcome_type":"secondary","measure":"Change from baseline in Fecal Calprotectin","time_frame":"Week 9","description":"Change from baseline in concentration of fecal Calprotectin"},{"outcome_type":"secondary","measure":"Changes from baseline in Inflammatory Bowel Disease Questionnaire score","time_frame":"Week 9","description":"Changes from baseline in Inflammatory Bowel Disease Questionnaire score Minimum value: 0, Maximum value: 224, higher score mean a worse outcome"},{"outcome_type":"secondary","measure":"Change from baseline in Histologic Disease Activity","time_frame":"Week 9","description":"Change from baseline in histologic disease activity measured by Geboes score"},{"outcome_type":"secondary","measure":"Safety measure through incidence of treatment-emergent adverse events (TEAEs)","time_frame":"Week 13","description":"Occurrence of TEAEs, treatment-related TEAEs, TEAEs by severity (mild/moderate/severe), serious TEAEs, TEAEs leading to dose adjustment, treatment termination, or death will be summarized by actual treatment groups respectively."}]}
{"nct_id":"NCT04998149","start_date":"2021-08-31","phase":"N/A","enrollment":598,"brief_title":"The Effect of the Use of Peanut Ball on Labor Time in Nulliparous Women","official_title":"The Effect of the Use of a Peanut Ball on Labor Time and \"Pushing\" After Epidural Anesthesia in Nulliparous Women.","primary_completion_date":"2023-03-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2023-03-31","last_update":"2021-08-10","description":"Peanut ball use has become popular with midwives and nurses because it is an inexpensive, nonpharmacological intervention that can help with positioning the patient to decrease labor time. The peanut ball allows the patient to reposition her legs in a way that mimics squatting and changes the diameter of the pelvis. This can aid in cervical dilatation and the descent of the fetus. In turn, laboring down can decrease the time spent pushing and prevent maternal exhaustion. This study aims to test the following hypotheses: The use of the peanut ball compared to standard of care will: 1. Reduce the time (in minutes) between administration of epidural and complete cervical dilation 2. Reduce pushing time as measured by duration of time pushing to the delivery of the baby 3. Decrease the rate of cesarean sections in nulliparous women","other_id":"21-0330","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","intervention_model_description":"There will be a standard group and an intervention group selected by BRMS.","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Women between 18 -50 years of age presenting in labor or for induction of labor\r\n\r\n          -  Nulliparous (first delivery)\r\n\r\n          -  37 0/7- 41 6/7 weeks of gestation\r\n\r\n          -  Singleton, Vertex presentation\r\n\r\n          -  Plan to deliver with epidural anesthesia\r\n\r\n          -  Has had at least one vaginal exam to determine the cervical dilatation prior to the\r\n             proposed intervention\r\n\r\n          -  Prescribed Oxytocin (Pitocin)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Multi gravida women\r\n\r\n          -  Admitted in second stage of labor\r\n\r\n          -  Multiple gestations\r\n\r\n          -  Non-vertex presentations\r\n\r\n          -  Women receiving magnesium sulfate\r\n\r\n          -  Preterm or post term labor (<37 weeks or >42 weeks)\r\n\r\n          -  Women with hypertensive disorders of pregnancy\r\n\r\n          -  Diabetes including gestational diabetes\r\n\r\n          -  Muscular or skeletal limitations that does not allow for positioning\r\n\r\n          -  Un-medicated labors ( delivery without epidural, about 5-20% )\r\n\r\n          -  Category III fetal heart rate tracings\r\n\r\n          -  Suspected infections (e.g. STDs, viral/bacterial infections)\r\n\r\n          -  Planned cesarean delivery\r\n      ","sponsor":"Northwell Health","sponsor_type":"Other","conditions":"Laboring Women","interventions":[{"intervention_type":"Device","name":"Device: Peanut Ball positioning device","description":"Peanut Ball manufactured by Clinton industries at graylinemedical.com https://www.graylinemedical.com/products/clinton-industries-peanut-ball-peanut-ball-40-cm-yellow-8540?_pos=3&_sid=d6e52e63c&_ss=r"}],"outcomes":[{"outcome_type":"primary","measure":"Decrease labor time","time_frame":"From epidural analgesia to delivery of the baby","description":"The primary outcome goal is to decrease the length of first and second stage of labor in nulliparous women after receiving epidural analgesia, measured in minutes"},{"outcome_type":"secondary","measure":"Decrease cesarean section deliveries","time_frame":"From epidural analgesia to delivery of the baby","description":"to decrease the rate of cesarean births among nulliparous women and to decrease the rate of operative vaginal deliveries (forceps/vacuum) by 10%."}]}
{"nct_id":"NCT04841512","start_date":"2021-08-31","phase":"Phase 1/Phase 2","enrollment":60,"brief_title":"Preliminary Safety and Efficacy of XT-150 in Facet Joint Osteoarthritis","official_title":"A Placebo-controlled, Double-blind Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Facet Joint Osteoarthritis Pain","primary_completion_date":"2022-08-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2022-09-30","last_update":"2021-08-04","description":"Preliminary safety and efficacy of XT-150 in the synovial capsule of osteoarthritic facet joints in the vertebra of the spine.","other_id":"XT-150-1-0301","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":90,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Male or female, between 18 and 90 years of age, inclusive.\r\n\r\n          2. Sufficiently severe facet arthropathy (OA) of lumbar facets as determined by imaging,\r\n             eg. CT or MRI, to establish an underlying basis of disease, as determined by usual\r\n             bony and ligamentous signs of OA.\r\n\r\n          3. Complaint of nociceptive, mechanical pain of lumbar spine, in particular pain\r\n             localized to paramedian axis as opposed to midline or radicular. Radicular pain as a\r\n             secondary finding may be allowed if it is addition to mechanical pain and can be\r\n             clinically distinguished by subject\r\n\r\n          4. Low Back Pain (LBP) worsened by activity or motion of region\r\n\r\n          5. Have had a positive diagnostic facet pain block with lignocaine; admittance if subject\r\n             gains 50% relief of pain within 30 minutes of test injection\r\n\r\n          6. Be free of local or intra-articular infection, tumor or other causes of localized LBP,\r\n             for example Including spondylolysis/pars defect, and adjacent vertebral body\r\n             compression fracture based on MRI evaluation.\r\n\r\n          7. Symptomatic disease because of osteoarthritis, established by imaging of facet joint\r\n             and defined as a worst pain of at least 40 at any time during the preceding week\r\n             (based on scale of 0 to 100, with 100 representing \"pain as bad as you can imagine\")\r\n             using Visual Analog Scale (VAS).\r\n\r\n          8. Stable analgesic regimen during the 4 weeks prior to enrollment.\r\n\r\n          9. Inadequate pain relief (minimum 50 mean on VAS with prior therapies lasting 3\r\n             months.\r\n\r\n         10. In the judgment of the Investigator, acceptable general medical condition\r\n\r\n         11. Male and female participants who are heterosexually active and not surgically sterile\r\n             or post-menopausal must agree to use effective contraception, including abstinence,\r\n             for the duration of the study and for 3 months after the study is completed\r\n\r\n         12. Have suitable facet joint anatomy for intra-articular injection\r\n\r\n         13. Willing and able to return for the follow-up (FU) visits\r\n\r\n         14. Able to reliably provide pain assessment (FAST test score R20.7)\r\n\r\n         15. Able to read and understand study instructions, and willing and able to comply with\r\n             all study procedures\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Hypersensitivity, allergy, or significant reaction to any ingredient of the study\r\n             drug, including double-stranded DNA, mannose, and sucrose\r\n\r\n          2. Scheduled surgical procedure or nerve ablation to joint within the next 6 months;\r\n             participant agrees not to schedule a surgical procedure, nerve ablation, or added\r\n             facet injection within 6 months of study treatment\r\n\r\n          3. High peri-operative risks which in the judgment of the investigator preclude a safe\r\n             facet joint injection procedure (e.g. extreme obesity putting injection accuracy at\r\n             risk, etc.)\r\n\r\n          4. Current treatment with immunosuppressive (systemic corticosteroid therapy [equivalent\r\n             to >10mg/day prednisone] or other strong immunosuppressant)\r\n\r\n          5. History of immunosuppressive therapy; high-potency systemic steroids in the last 3\r\n             months.\r\n\r\n          6. Currently receiving systemic chemotherapy or radiation therapy for malignancy\r\n\r\n          7. Clinically significant hepatic disease as indicated by clinical laboratory results 3\r\n             times the upper limit of normal for any liver function test (e.g., aspartate\r\n             aminotransferase, alanine aminotransferase, lactate dehydrogenase)\r\n\r\n          8. Severe anemia (Grade 3; hemoglobin <8.0 g/dL, <4.9 mmol/L, <80 g/L; transfusion\r\n             indicated), Grade 1 white cell counts (lymphocytes <LLN - 800/mm3; <LLN - 0.8 x 109\r\n             /L, neutrophils <LLN - 1500/mm3; <LLN - 1.5 x 109 /L)\r\n\r\n          9. Positive serology with reflex for human immunodeficiency virus, hepatitis B virus, or\r\n             hepatitis C virus within 4 weeks of commencing the study\r\n\r\n         10. Significant neuropsychiatric conditions; dementia, major depression, or altered mental\r\n             state that in the opinion of the Investigator will interfere with study participation\r\n\r\n         11. Current treatment with systemic antibiotics or antivirals (EXCEPTION: topical\r\n             treatments)\r\n\r\n         12. Current treatment with anticoagulants, other than low-dose aspirin\r\n\r\n         13. Known or suspected history of active alcohol or intravenous/oral drug abuse within 1\r\n             year before the screening visit\r\n\r\n         14. Use of any investigational drug or device within 1 month before enrollment or current\r\n             participation in a trial that included intervention with a drug or device; or\r\n             currently participating in an investigational drug or device study.\r\n\r\n         15. Any condition that, in the opinion of the Principal Investigator, could compromise the\r\n             safety of the participant, the participant's ability to communicate with the study\r\n             staff, or the quality of the data\r\n      ","sponsor":"Xalud Therapeutics, Inc.","sponsor_type":"Industry","conditions":"Osteoarthritis, Spine","interventions":[{"intervention_type":"Biological","name":"Biological: XT-150","description":"non-viral Plasmid DNA encoding an IL-10 variant transgene"}],"outcomes":[{"outcome_type":"primary","measure":"Visual analog scale (VAS)","time_frame":"6 months","description":"0 - 100, 100 worst possible pain"},{"outcome_type":"secondary","measure":"Oswestry Disability Index","time_frame":"6 months","description":"10 dimensions, 0 - 5 score in each, with 5 as worst score in a dimension"}]}
{"nct_id":"NCT05001854","start_date":"2021-08-31","phase":"Phase 2/Phase 3","enrollment":40,"brief_title":"Hemodynamics Effects of Fludrocortisone on the Pressor Response to Noradrenaline Septic Shock Patients","official_title":"Evaluation of the Hemodynamics Effects of Fludrocortisone on the Pressor Response to Noradrenaline in Septic Shock Patients","primary_completion_date":"2023-10-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2024-04-30","last_update":"2021-08-12","description":"The benefit of low-dose steroids in septic shock is still debated today, especially with mineralocorticoids. Fludrocortisone is a synthetic mineralocorticoid, an analogue of aldosterone, which has shown, in combination with hydrocortisone, a favorable effect on the mortality of septic shock patients with relative adrenal insufficiency. In a previous study in healthy volunteers, we showed for the first time that fludrocortisone at a dose of 400 g per day significantly improved the pressor response to phenylephrine. These results confirm the observations reported in rats with endotoxin shock, where fludrocortisone was shown to significantly increase blood pressure and contractile response to phenylephrine. These encouraging results argue for a potential vascular beneficial effect of fludrocortisone and need to be confirmed in a population of septic shock patients. In this context, we aimed to evaluate the effect of oral administration of 100 g every 6 hours of fludrocortisone on vascular responsiveness to noradrenaline in septic shock patients.","other_id":"35RC19_8860","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age > 18 years\r\n\r\n          -  Patient with septic shock for less than 24 hours, defined according to The Third\r\n             International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) by the\r\n             combination of:\r\n\r\n               -  Sepsis defined as organ dysfunction caused by an inappropriate host response to\r\n                  infection (increase in SOFA score of at least 2 points secondary to infection),\r\n\r\n               -  Persistent hypotension requiring vasopressor drugs to maintain mean arterial\r\n                  pressure  65 mmHg,\r\n\r\n               -  Serum lactate level > 2 mmol/l despite adequate vascular filling.\r\n\r\n          -  Hemodynamic stability for >30 min with mean arterial pressure  65 mmHg and\r\n             noradrenaline dose  0.5 g/kg/min,\r\n\r\n          -  Consent signed by the patient, family member, or legal representative or inclusion\r\n             under emergency procedure,\r\n\r\n          -  Negative to a diagnostic test for SARS-CoV2 less than 72 hours old; the test used must\r\n             be on the the list published on the Ministry of Solidarity and Health website\r\n\r\n        Non-inclusion Criteria:\r\n\r\n          -  Current treatment with steroids or other treatment that may affect the\r\n             hypothalamic-pituitary-adrenal axis,\r\n\r\n          -  Anesthetic induction with etomidate within 6 hours prior to randomization given its\r\n             selective inhibitory effect on 11 -hydroxylase,\r\n\r\n          -  Known hypersensitivity to fludrocortisone (or any of its excipients), or to\r\n             tetracosactide (Synacthen),\r\n\r\n          -  Disturbed gastric emptying (gastric residue > 500 ml) in the absence of an alternative\r\n             route of administration available (naso-jejunal tube or jejunostomy),\r\n\r\n          -  Pregnant or nursing woman,\r\n\r\n          -  Patient participating in another trial, possibly interfering with the study\r\n             procedures,\r\n\r\n          -  Person not affiliated to a social security system,\r\n\r\n          -  Known situation of deprivation of freedom (safeguard of justice), guardianship or\r\n             curatorship,\r\n\r\n          -  Patient with a life expectancy of less than 24 hours.\r\n\r\n          -  Patient with known or suspected SARS-CoV2 pneumonia\r\n\r\n        Exclusion criteria:\r\n\r\n          -  Patients under court protection will be excluded as soon as the investigator is aware\r\n             of their status.\r\n\r\n          -  Hemodynamic worsening with noradrenaline dose >1.5 g/kg/min before evaluation of the\r\n             primary end point.\r\n\r\n          -  Catecholamine withdrawal before evaluation of the primary end point.\r\n      ","sponsor":"Rennes University Hospital","sponsor_type":"Other","conditions":"Septic Shock","interventions":[{"intervention_type":"Drug","name":"Drug: Fludrocortisone","description":"100 g every 6 hours of fludrocortisone per os"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"100 g every 6 hours of placebo per os"}],"outcomes":[{"outcome_type":"secondary","measure":"Cardiac index","time_frame":"Baseline, before the first administration of the experimental drug (fludrocortisone/placebo)","description":"Cardiac index"},{"outcome_type":"secondary","measure":"Cardiac index","time_frame":"1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)","description":"Cardiac index"},{"outcome_type":"primary","measure":"Mean arterial blood pressure (mmHg)","time_frame":"1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)","description":"Mean arterial blood pressure (mmHg) after a dose escalation of norepinephrine in increments of 0.2 μg/kg/min to a maximum dose of 1.5 μg/kg/min."},{"outcome_type":"secondary","measure":"Heart rate","time_frame":"Baseline, before the first administration of the drug (fludrocortisone/placebo)","description":"Heart rate"},{"outcome_type":"secondary","measure":"Heart rate","time_frame":"1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)","description":"Heart rate"},{"outcome_type":"secondary","measure":"Heart rate","time_frame":"After the 3rd administration of fludrocortisone or placebo (12 hours)","description":"Heart rate"},{"outcome_type":"secondary","measure":"Heart rate","time_frame":"After the 4th administration of fludrocortisone or placebo (18 hours)","description":"Heart rate"},{"outcome_type":"secondary","measure":"arterial pressure","time_frame":"Baseline, before the first administration of the experimental drug (fludrocortisone/placebo)","description":"Mean arterial pressure, systolic arterial pressure, diasystolic arterial pressure"},{"outcome_type":"secondary","measure":"arterial pressure","time_frame":"1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)","description":"Mean arterial pressure, systolic arterial pressure, diasystolic arterial pressure"},{"outcome_type":"secondary","measure":"arterial pressure","time_frame":"After the 3rd administration of fludrocortisone or placebo (12 hours)","description":"Mean arterial pressure, systolic arterial pressure, diasystolic arterial pressure"},{"outcome_type":"secondary","measure":"arterial pressure","time_frame":"After the 4th administration of fludrocortisone or placebo (18 hours)","description":"Mean arterial pressure, systolic arterial pressure, diasystolic arterial pressure"},{"outcome_type":"secondary","measure":"Cardiac output","time_frame":"Baseline, before the first administration of the experimental drug (fludrocortisone/placebo)","description":"Cardiac output"},{"outcome_type":"secondary","measure":"Cardiac output","time_frame":"1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)","description":"Cardiac output"},{"outcome_type":"secondary","measure":"Cardiac output","time_frame":"After the 3rd administration of fludrocortisone or placebo (12 hours)","description":"Cardiac output"},{"outcome_type":"secondary","measure":"Cardiac output","time_frame":"After the 4th administration of fludrocortisone or placebo (18 hours)","description":"Cardiac output"},{"outcome_type":"secondary","measure":"Cardiac index","time_frame":"After the 3rd administration of fludrocortisone or placebo (12 hours)","description":"Cardiac index"},{"outcome_type":"secondary","measure":"Cardiac index","time_frame":"After the 4th administration of fludrocortisone or placebo (18 hours)","description":"Cardiac index"},{"outcome_type":"secondary","measure":"Indexed Systemic Vascular Resistances (ISVR)","time_frame":"Baseline, before the first administration of the experimental drug (fludrocortisone/placebo)","description":"Indexed Systemic Vascular Resistances (ISVR)"},{"outcome_type":"secondary","measure":"Indexed Systemic Vascular Resistances (ISVR)","time_frame":"1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)","description":"Indexed Systemic Vascular Resistances (ISVR)"},{"outcome_type":"secondary","measure":"Indexed Systemic Vascular Resistances (ISVR)","time_frame":"After the 3rd administration of fludrocortisone or placebo (12 hours)","description":"Indexed Systemic Vascular Resistances (ISVR)"},{"outcome_type":"secondary","measure":"Indexed Systemic Vascular Resistances (ISVR)","time_frame":"After the 4th administration of fludrocortisone or placebo (18 hours)","description":"Indexed Systemic Vascular Resistances (ISVR)"},{"outcome_type":"secondary","measure":"Indexed Global Telediastolic Volume (IGVT)","time_frame":"Baseline, before the first administration of the experimental drug (fludrocortisone/placebo)","description":"Indexed Global Telediastolic Volume (IGVT)"},{"outcome_type":"secondary","measure":"Indexed Global Telediastolic Volume (IGVT)","time_frame":"1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)","description":"Indexed Global Telediastolic Volume (IGVT)"},{"outcome_type":"secondary","measure":"Indexed Global Telediastolic Volume (IGVT)","time_frame":"After the 3rd administration of fludrocortisone or placebo (12 hours)","description":"Indexed Global Telediastolic Volume (IGVT)"},{"outcome_type":"secondary","measure":"Indexed Global Telediastolic Volume (IGVT)","time_frame":"After the 4th administration of fludrocortisone or placebo (18 hours)","description":"Indexed Global Telediastolic Volume (IGVT)"},{"outcome_type":"secondary","measure":"Ejection Volume Variability (EVV)","time_frame":"Baseline, before the first administration of the experimental drug (fludrocortisone/placebo)","description":"Ejection Volume Variability (EVV)"},{"outcome_type":"secondary","measure":"Ejection Volume Variability (EVV)","time_frame":"1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)","description":"Ejection Volume Variability (EVV)"},{"outcome_type":"secondary","measure":"Ejection Volume Variability (EVV)","time_frame":"After the 3rd administration of fludrocortisone or placebo (12 hours)","description":"Ejection Volume Variability (EVV)"},{"outcome_type":"secondary","measure":"Ejection Volume Variability (EVV)","time_frame":"After the 4th administration of fludrocortisone or placebo (18 hours)","description":"v"},{"outcome_type":"secondary","measure":"Extravascular Pulmonary Water (EVW)","time_frame":"Baseline, before the first administration of the experimental drug (fludrocortisone/placebo)","description":"Extravascular Pulmonary Water (EVW)"},{"outcome_type":"secondary","measure":"Extravascular Pulmonary Water (EVW)","time_frame":"1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)","description":"Extravascular Pulmonary Water (EVW)"},{"outcome_type":"secondary","measure":"Extravascular Pulmonary Water (EVW)","time_frame":"After the 3rd administration of fludrocortisone or placebo (12 hours)","description":"Extravascular Pulmonary Water (EVW)"},{"outcome_type":"secondary","measure":"Extravascular Pulmonary Water (EVW)","time_frame":"After the 4th administration of fludrocortisone or placebo (18 hours)","description":"Extravascular Pulmonary Water (EVW)"},{"outcome_type":"secondary","measure":"Mortality","time_frame":"Day 28","description":"Percentage of deceased patients"},{"outcome_type":"secondary","measure":"Mortality","time_frame":"Day 90","description":"Percentage of deceased patients"},{"outcome_type":"secondary","measure":"Length of stay in intensive care unit","time_frame":"Day 90","description":"Length of stay in intensive care unit"},{"outcome_type":"secondary","measure":"Length of stay in care unit","time_frame":"Day 90","description":"Length of stay in care unit"},{"outcome_type":"secondary","measure":"Time to wean from catecholamines","time_frame":"Day 90","description":"Time to wean from catecholamines"},{"outcome_type":"secondary","measure":"Duration of mechanical ventilation (MV)","time_frame":"Day 90","description":"Duration of mechanical ventilation (MV)"},{"outcome_type":"secondary","measure":"Inflammation markers","time_frame":"Baseline, before the first administration of the experimental drug (fludrocortisone/placebo)","description":"IFNγ, TNF α, IL1β, IL6, IL10 dosage"},{"outcome_type":"secondary","measure":"Inflammation markers","time_frame":"1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)","description":"IFNγ, TNF α, IL1β, IL6, IL10 dosage"},{"outcome_type":"secondary","measure":"natremia dosage","time_frame":"Baseline, before the first administration of the experimental drug (fludrocortisone/placebo)","description":"blood sodium"},{"outcome_type":"secondary","measure":"natremia dosage","time_frame":"1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)","description":"blood sodium"},{"outcome_type":"secondary","measure":"urinary sodium dosage","time_frame":"Baseline, before the first administration of the experimental drug (fludrocortisone/placebo)","description":"urinary sodium"},{"outcome_type":"secondary","measure":"urinary sodium dosage","time_frame":"1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)","description":"urinary sodium"},{"outcome_type":"secondary","measure":"kalemia dosage","time_frame":"Baseline, before the first administration of the experimental drug (fludrocortisone/placebo)","description":"blood potassium"},{"outcome_type":"secondary","measure":"kalemia dosage","time_frame":"1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)","description":"blood potassium"},{"outcome_type":"secondary","measure":"urinary potassium dosage","time_frame":"Baseline, before the first administration of the experimental drug (fludrocortisone/placebo)","description":"urinary potassium"},{"outcome_type":"secondary","measure":"urinary potassium dosage","time_frame":"1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)","description":"urinary potassium"},{"outcome_type":"secondary","measure":"pharmacokinetics of fludrocortisone : Area under the plasma concentration-time curve (plasma concentrations of fludrocortisone at 5 times)","time_frame":"After 4th dose of fludrocortisone (18 hours)","description":"in the experimental group only."},{"outcome_type":"other","measure":"Dose-response relationship","time_frame":"1,5 hours after the second administration of fludrocortisone or placebo (7,5 hours)","description":"The dose-response relationship (mean arterial blood pressure to doses of norepinephrine) will be modeled according to a sigmoid Emax model with determination of the maximum effect (Emax) obtained on blood pressure, estimation of the dose of norepinephrine inducing half of the Emax (ED50), and the Hill coefficient γ reflecting the sigmoidality of the curve."}]}
{"nct_id":"NCT05023577","start_date":"2021-08-26","phase":"Phase 4","enrollment":504,"brief_title":"Antibiotic Combination for H. Pylori Eradication in Penicillin-allergic Patients","official_title":"Clarithromycin-, Metronidazole-, or Levofloxacin-containing Therapy for Helicobacter Pylori-infected Penicillin-allergic Patients: A Randomized Controlled Trial","primary_completion_date":"2022-12-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-12-30","last_update":"2021-09-14","description":"This randomized controlled clinical trial will compare the eradication efficacy of bismuth quadruple therapy containing clarithromycin+metronidazole, clarithromycin+levofloxacin, or metronidazole+levofloxacin for Helicobacter pylori first-line treatment in penicillin-allergic patients. The completion of this trial will expand new therapy for the treatment of Helicobacter pylori, which can not only ensure clinical efficacy, but also reduce the use of antibiotics.","other_id":"B2021-3762","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Participate in the trial voluntarily, fully understand the trial, and sign the\r\n             informed consent form (ICF).\r\n\r\n          -  18-75 years old on the day of signing the ICF.\r\n\r\n          -  Helicobacter pylori infection confirmed by 13C-urea breath test or rapid urease test.\r\n\r\n          -  Have not received Helicobacter pylori eradication treatment before.\r\n\r\n          -  allergic to penicillin.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Have received Hp eradication treatment.\r\n\r\n          -  Patients with severe heart, lung, kidney, liver, blood, nerve, endocrine, and\r\n             psychiatric diseases.\r\n\r\n          -  Subjects or guardians refused to participate in the trial.\r\n\r\n          -  Alcohol and/or drugs Abuse (addiction or dependence) or poor compliance with doctor's\r\n             judgment.\r\n\r\n          -  Have taken antibiotics, bismuth, proton pump inhibitors or Chinese traditional\r\n             medicine 4 weeks before treatment.\r\n\r\n          -  Pregnant or lactating women.\r\n\r\n          -  Active peptic ulcer.\r\n\r\n          -  allergic to drugs used in the trial.\r\n\r\n          -  any other circumstances that are not suitable for recruitment.\r\n      ","sponsor":"Shanghai Zhongshan Hospital","sponsor_type":"Other","conditions":"Helicobacter Pylori Infection","interventions":[{"intervention_type":"Drug","name":"Drug: Rabeprazole","description":"20mg bid"},{"intervention_type":"Drug","name":"Drug: Bismuth potassium citrate","description":"0.6g bid"},{"intervention_type":"Drug","name":"Drug: Metronidazole","description":"0.4g qid"},{"intervention_type":"Drug","name":"Drug: Clarithromycin","description":"0.5g bid"},{"intervention_type":"Drug","name":"Drug: Levofloxacin","description":"0.5g qd"}],"outcomes":[{"outcome_type":"primary","measure":"Eradication rate of Helicobacter pylori","time_frame":"At least 4 weeks after completion of therapy","description":"Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value)."},{"outcome_type":"secondary","measure":"Eradication rate of Helicobacter pylori resistant strains","time_frame":"At least 4 weeks after completion of therapy","description":"Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value). The antibiotic resistant strains were assessed using the E test method."},{"outcome_type":"secondary","measure":"Eradication rate of Helicobacter pylori susceptible strains","time_frame":"At least 4 weeks after completion of therapy","description":"Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value). The antibiotic susceptible strains were assessed using the E test method."},{"outcome_type":"other","measure":"Adherence rate","time_frame":"2 weeks during therapy","description":"Adherence was defined as poor when subjects took less than 80% of the total medication."},{"outcome_type":"other","measure":"Frequency of adverse events","time_frame":"2 weeks during therapy","description":"Any possible adverse events during the 14-day treatment period were recorded."}]}
{"nct_id":"NCT04723303","start_date":"2021-08-25","phase":"Early Phase 1","enrollment":9,"brief_title":"Phase 1 Study of ULSC in Patients With Polymyositis (PM) and Dermatomyositis (DM)","official_title":"Phase 1 Study of Mesenchymal Stromal Cells, Umbilical Cord Lining Stem Cells (ULSC), in Patients With Polymyositis (PM) and Dermatomyositis (DM)","primary_completion_date":"2022-02-28","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-02-28","last_update":"2021-07-29","description":"This study will investigate Umbilical Cord Lining Stem Cells (ULSC) as an investigational medicinal product and its use in patients with polymyositis (PM) or dermatomyositis (DM) to see if a single intravenous (IV) infusion of allogeneic umbilical cord lining stem cells (ULSC) safe, tolerable, and feasible to administer.","other_id":"DM/PM V2.0","allocation":"N/A","intervention_model":"Sequential Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Study Participants will be assigned to one of 3 doses of stem cells depending on when the subject is enrolled. The first three patients will be assigned to the low dose group, the next three patients will be assigned the intermediate dose group and last three patients will receive the high dose of ULSC's. An independent review group will evaluate the response to therapy to each dose group before moving to the next dose. The groups and doses are described below:\r\nA low dose group receives an IV infusion of 50 million stem cells.\r\nAn intermediate dose group receives an IV infusion of 100 million stem cells.\r\nA high dose group receives an IV infusion of 200 million stem cells.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":90,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Adult, male or female, age 18 years old\r\n\r\n          2. Diagnosis of definite or probable DM or PM, according to the criteria of Bohan and\r\n             Peter\r\n\r\n          3. Patients with PM will either be positive for a myositis-associated antibody or have\r\n             undergone evaluation to exclude mimics, as deemed appropriate by the Investigator (See\r\n             Note below).\r\n\r\n          4. Signs informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. A diagnosis of inclusion body myositis, juvenile DM or PM, myositis in the context of\r\n             significant overlap with another systemic autoimmune rheumatologic disease.\r\n\r\n          2. Non immune myopathies.\r\n\r\n          3. Cancer associated myositis.\r\n\r\n          4. Hypersensitivity to study product components. History of hypersensitivity to dimethyl\r\n             sulfoxide (DMSO).\r\n\r\n          5. Pregnant or lactating women.\r\n\r\n          6. Concomitant severe cardiac, pulmonary disease, active infection or other conditions\r\n             that preclude assessment of safety and efficacy of the study product.\r\n\r\n          7. Patients with predominant muscle atrophy secondary to uncontrolled or chronic DM or\r\n             PM, based on clinical, biochemical, and/or radiologic assessment, despite previous\r\n             optimized treatment.\r\n\r\n          8. Anticipated need for surgery during the trial period.\r\n\r\n          9. A history of prevalent noncompliance with medical therapy.\r\n\r\n         10. Recipient of an organ transplant.\r\n\r\n         11. Neutropenia (absolute neutrophil count<1,800/mm3 [or <1,000/mm3 in African-American\r\n             subjects]).\r\n\r\n         12. Severe impairment in renal function (estimated glomerular filtration rate <30\r\n             ml/kg*min).\r\n\r\n         13. Recent or planned use of vaccination with live attenuated viruses.\r\n\r\n         14. Active cancer or prior diagnosis of cancer within the past 2 years (patients with\r\n             basal and squamous cell cancer of skin will not be excluded).\r\n\r\n         15. Condition that would impair an assessment of muscle strength, including neurological\r\n             disorders such as Parkinson's disease or severe musculoskeletal condition.\r\n\r\n         16. Any other condition that, in the judgment of the Investigator or Sponsor, would be a\r\n             contraindication to enrollment, study product administration, or follow-up.\r\n\r\n         17. History of Atrial septal defect or ventricular septal defect\r\n      ","sponsor":"University of Florida","sponsor_type":"Other","conditions":"Polymyositis|Dermatomyositis","interventions":[{"intervention_type":"Drug","name":"Drug: MESENCHYMAL STROMAL CELLS (MSC's)","description":"An IV infusion of ULSCs will be administered."}],"outcomes":[{"outcome_type":"primary","measure":"Number of Subjects with Dose Limiting Toxicity (DLT) that begins during or following ULSC infusion as assessed within 24 hours.","time_frame":"Within 24 hours","description":"Dose Limiting Toxicities are treatment-emergent suspected adverse reactions graded severe, such as severe infusion-related hypersensitivity toxicities of grade ≥3, and any serious adverse event (SAE). (Note: DLT during an infusion will stop that infusion in that subject.)"}]}
{"nct_id":"NCT04630496","start_date":"2021-08-25","phase":"N/A","enrollment":30,"brief_title":"Geriatric Thoracic Surgery Ambulation Challenge","official_title":"Pre-Operative Exercise Challenge In Geriatric Thoracic Patients","primary_completion_date":"2022-01-23","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-01-23","last_update":"2021-09-10","description":"This study is examining collecting data on steps walked (ambulation) per day by thoracic surgery patients over the age of 70 years-old before surgery. The name(s) of the study device involved in this study is: - Fitbit inspire","other_id":"20-061","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients Aged  70 years\r\n\r\n               -  Who are preparing to undergo lung resection of the magnitude of wedge resection\r\n                  or greater (segmentectomy, lobectomy, bilobectomy, or pneumonectomy) at Brigham\r\n                  and Women's Hospital (BWH)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who are completely non-ambulatory (i.e. wheelchair-bound-patients) *\r\n\r\n          -  Those who lack capacity to consent due to cognitive disease.\r\n\r\n          -  Patient for which surgery is felt to be more urgent and therefore performed earlier\r\n             then our required timeframe for intervention.\r\n\r\n          -  Patients with cardiac disease or angina for which formal cardiac testing is required\r\n             for clearance.\r\n\r\n               -  Our exclusion criteria do not include patients with gait disturbances or those\r\n                  who require assistance devices for ambulation.\r\n      ","sponsor":"Dana-Farber Cancer Institute","sponsor_type":"Other","conditions":"Thoracic Diseases|Surgery|Therapy, Exercise","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Fitbit","description":"Electronic activity tracker"}],"outcomes":[{"outcome_type":"primary","measure":"Step Tracking Rate","time_frame":"1 week","description":"Feasibility will be determined by the successful tracking of steps and keeping a diary of step-count for one-week duration. Completion of a minimum of 5/7 days will be considered as a success"},{"outcome_type":"primary","measure":"Diary of Steps Rate","time_frame":"1 week","description":"Feasibility will be determined by the successful tracking of steps and keeping a diary of step-count for one-week duration. We will consider completion of a minimum of 5/7 days as a success."},{"outcome_type":"primary","measure":"Return Rate","time_frame":"1 week","description":"If 90% of trackers are returned, it will be considered a successful return."},{"outcome_type":"primary","measure":"Data Retrieval Rate","time_frame":"1 week","description":"assess extraction of the data from the mobility upon return. Success will be considered if 90% of data is retrievable"}]}
{"nct_id":"NCT04948034","start_date":"2021-08-23","phase":"Phase 2","enrollment":68,"brief_title":"The Combination of Fruquintinib, Tislelizumab and Stereotactic Ablative Radiotherapy in Metastatic Colorectal Cancer(RIFLE)","official_title":"A Phase  Trial of Multisite Stereotactic Ablative Radiotherapy (SABR) Combined With Fruquintinib and Tislelizumab in Metastatic Colorectal Cancer","primary_completion_date":"2022-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-12-31","last_update":"2021-08-27","description":"This is a prospective, single-center, single-arm phase II clinical trial.This study aims to evaluate the safety and tolerability of stereotactic ablative radiotherapy (SABR) in combination with Fruquintinib and Tislelizumab, and to examine the impact of the combination therapy on tumor control, long-term survival and quality of life in patients with Metastatic colorectal cancer. A total of 68 metastatic colorectal cancer patients who have failed the first-line standard treatment, will be recruited and receive multisite SABR(8-12 Gy, 4-5 times) followed by fruquintinib(5mg, qd) and tislelizumab(200mg, q3w) within two weeks from completion.The overall response rate (ORR), disease control rate(DCR), progression-free survival(PFS) and overall survival(OS) will be analyzed.","other_id":"FDRT-2020-274-2194","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Aged over 18 years old, regardless of gender\r\n\r\n          -  Fully informed and willing to provide written informed consent for the trial\r\n\r\n          -  ECOG performance status 0-1\r\n\r\n          -  Has an investigator determined life expectancy of at least 6 months\r\n\r\n          -  Histologically or cytologically confirmed stage IV colorectal cancer (UICC 8th\r\n             version)\r\n\r\n          -  Has at least 2 measurable oligometastatic lesions on imaging (RECIST version 1.1). One\r\n             will be treated with SABR and the other will be biopsied and evaluated against RECIST\r\n             1.1.\r\n\r\n          -  Has progressive disease after receiving first-line standard antitumor therapy\r\n             (chemotherapeutic agents including fluorouracil, oxaliplatin and irinotecan); previous\r\n             neoadjuvant or adjuvant pelvic area radiotherapy is allowed; subjects included in the\r\n             safety introduction phase may include third-line treatment or above, but these\r\n             subjects will not be included in the final statistical analysis.\r\n\r\n          -  Subjects receiving adjuvant oxaliplatin should progress during adjuvant therapy or\r\n             within 6 months after completion.\r\n\r\n          -  Demonstrate adequate organ function (bone marrow, liver, kidney and clotting function)\r\n             within 7 days before the first administration without using blood products or\r\n             hematopoietic stimulating factors.\r\n\r\n          -  Subjects who withdraw from standard treatment before disease progressing due to\r\n             unacceptable toxicity and exclude the use of the same drug are also allowed to be\r\n             included.\r\n\r\n          -  Non pregnant or lactating patients. Effective contraceptive methods should be used\r\n             during the study and within 6 months of the last administration.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnant or lactating women\r\n\r\n          -  The presence of a clinically detectable second primary malignancy, or history of other\r\n             malignancies within 5 years excluding adequately treated non-melanoma skin cancer,\r\n             carcinoma in situ of cervix and superficial bladder tumor (non-invasive tumor, or\r\n             carcinoma in situ, or T1)\r\n\r\n          -  Baseline laboratory indicators do not meet the following criteria: neutrophils\r\n             1.510^9/L, Hb90g/L, PLT10010^9/L , ALT 2.5 ULN, AST 2.5 ULN, Cr 1.5 ULN or\r\n             creatinine clearance rate <50ml/min, TBIL 1.5 ULN, APTT 1.5 ULN, PT 1.5 ULN (the\r\n             criteria of patients with liver metastasis: PLT 8010^9/L, ALT 5 ULN, AST 5 ULN,\r\n             TBIL 2.5 ULN)\r\n\r\n          -  Serious electrolyte abnormalities\r\n\r\n          -  Urinary protein  2+, or 24-hour urine protein 1.0g/24h\r\n\r\n          -  Uncontrolled hypertension: SBP >140mmHg or DBP > 90mmHg\r\n\r\n          -  Receiving radiotherapy within 4 weeks\r\n\r\n          -  Receiving anti-VEGF or anti-EGFR therapy within 4 weeks\r\n\r\n          -  Stroke event or transient ischemic attack occurred within 12 months\r\n\r\n          -  A history of arterial thrombosis or deep vein thrombosis within 6 months; a history of\r\n             bleeding or evidence of bleeding tendency within 2 months\r\n\r\n          -  A histroy of heart disease within 6 months (including congestive heart failure, acute\r\n             myocardial infarction, severe/unstable angina, coronary artery bypass grafting,\r\n             cardiac insufficiency  NYHA grade 2 and LVEF<50%)\r\n\r\n          -  Uncontrolled malignant pleural effusion, ascites, or pericardial effusion\r\n\r\n          -  Previous treatment with immunotherapy or fruquintinib\r\n\r\n          -  The presence of gastrointestinal diseases such as gastric or duodenal active ulcers,\r\n             ulcerative colitis or unresected tumors with active bleeding; or other conditions\r\n             likely to cause gastrointestinal bleeding or perforation; or unhealed gastrointestinal\r\n             perforation or gastrointestinal fistula after surgical treatment\r\n\r\n          -  A history of liver disease including, but not limited to HBV infection or HBV DNA\r\n             positive(110^4/ml), HCV infection or HCV DNA positive(110^3/ml) and liver\r\n             cirrhosis\r\n\r\n          -  Serious mental abnormalities\r\n      ","sponsor":"Fudan University","sponsor_type":"Other","conditions":"Metastatic Colorectal Cancer","interventions":[{"intervention_type":"Radiation","name":"Radiation: Stereotactic Ablative Radiotherapy (SABR)","description":"We plan to irradiate as many metastatic lesions as possible, in the precondition that normal tissues can tolerate.\r\nTarget dose will be adjusted depending on site of the lesion and organs at risk (BED > 100Gy).\r\nTreatment schedule is once per day and five days per week. Sequence of irradiation for multiple metastases is at the discretion of the investigators based on their experience."},{"intervention_type":"Drug","name":"Drug: Fruquintinib","description":"Starts within two weeks upon SABR completion: 5mg, d1-14, qd; Continued until disease progression, unacceptable toxicity or patient withdrawal."},{"intervention_type":"Drug","name":"Drug: Tislelizumab","description":"Starts within one week upon SABR completion: 200mg, d1, q3w; the dosing will continue for up to two years until disease progression, unacceptable toxicity or patient withdrawal."}],"outcomes":[{"outcome_type":"primary","measure":"Objective Response Rate","time_frame":"Up to 2 years","description":"The percentage of patients with objective response in the non-irradiated metastatic lesions. Objective response is defined as complete response (CR) or partial response (PR) per response evaluation criteria (RECIST v1.1) and the immune related response criteria (iRECIST) after treatment."},{"outcome_type":"secondary","measure":"Disease Control Rate","time_frame":"Up to 2 years","description":"The percentage of patients with disease control in the non-irradiated metastatic lesions. Disease control is defined as CR, PR, or stable disease (SD) per RECIST v1.1 and iRECIST after treatment."},{"outcome_type":"secondary","measure":"Duration of Response","time_frame":"Up to 2 years","description":"Defined as the time between PR/CR and subsequent progression disease (PD) per RECIST v1.1 and iRECIST or death from any cause."},{"outcome_type":"secondary","measure":"Progression-Free Survival","time_frame":"Up to 3 years","description":"Defined as the time from initiation of treatment to PD or death from any cause."},{"outcome_type":"secondary","measure":"Overall Survival","time_frame":"Up to 3 years","description":"Defined as the time from initiation of treatment to death from any cause."},{"outcome_type":"secondary","measure":"Acute Toxicity","time_frame":"Up to 2 years","description":"The percentage of patients with treatment-related acute toxicities as assessed by NCI CTCAE v5.0, from treatment initiation until 90 days upon completion of immunotherapy."}]}
{"nct_id":"NCT04989816","start_date":"2021-08-20","phase":"Phase 2","enrollment":75,"brief_title":"Study of T-DXd Monotherapy in Patients With HER2-positive Locally Advanced or Metastatic Gastric or GEJ Adenocarcinoma Who Have Received 2 or More Prior Regimens","official_title":"A Single-arm Study of Trastuzumab Deruxtecan (T-DXd) Monotherapy for Patients With HER2-positive Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Who Have Received 2 or More Prior Regimens (DESTINY-Gastric06)","primary_completion_date":"2022-12-28","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-08-31","last_update":"2021-09-16","description":"This is a Phase II, open-label, single-arm, multicentre, study in China assessing the efficacy and safety of T-DXd in participants with HER2-positive advanced gastric or GEJ adenocarcinoma who have received at least 2 prior regimens including a fluoropyrimidine agent and a platinum agent","other_id":"D9676C00002","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Single group assignment","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Male or female  18 years of age\r\n\r\n          2. Pathologically documented gastric or GEJ adenocarcinoma\r\n\r\n          3. Disease progression on or after  2 prior platinum and fluoropyrimidine agents for\r\n             advanced/metastatic disease\r\n\r\n          4. ECOG PS 0-1\r\n\r\n          5. Willing and able to provide an adequate newly-acquired tumour sample for confirmation\r\n             of HER2 status\r\n\r\n          6. LVEF  50%\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal\r\n             shunt, or Cell-free and CART. Drainage and CART.\r\n\r\n          2. Spinal cord compression or brain metastases unless asymptomatic, stable, and not\r\n             requiring steroids\r\n\r\n          3. Active primary immunodeficiency, known HIV, active HBV, HCV infection.\r\n\r\n          4. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.\r\n\r\n          5. History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD that\r\n             cannot be ruled out by imaging at screening.\r\n\r\n          6. Lung-specific intercurrent clinically significant severe illnesses.\r\n      ","sponsor":"AstraZeneca","sponsor_type":"Industry","conditions":"Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma","interventions":[{"intervention_type":"Drug","name":"Drug: Trastuzumab Deruxtecan","description":"Trastuzumab deruxtecan (T-DXd) by intravenous infusion"}],"outcomes":[{"outcome_type":"primary","measure":"Confirmed objective response rate by RECIST 1.1 based on independent central review (ICR)","time_frame":"An average of approximately 14 months","description":"Confirmed ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined by ICR per RECIST 1.1."},{"outcome_type":"secondary","measure":"investigator-assessed ORR","time_frame":"An average of approximately 14 months","description":"Confirmed ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined by the investigator at local site per RECIST 1.1"},{"outcome_type":"secondary","measure":"PFS","time_frame":"An average of approximately 14 months","description":"PFS is defined as time from date of first dose of study intervention until progression per RECIST 1.1 as assessed by ICR or death due to any cause. PFS will be evaluated based on ICR and on investigator assessment."},{"outcome_type":"secondary","measure":"DCR","time_frame":"Approximately 6 weeks","description":"DCR is defined as the percentage of participants who have a confirmed CR/PR or who have SD for at least 5 weeks (without subsequent anticancer therapy) after date of first dose of study intervention. DCR will be evaluated based on ICR and on investigator assessment."},{"outcome_type":"secondary","measure":"DoR","time_frame":"An average of approximately 14 months","description":"DoR is defined as the time from the date of first documented response until date of documented progression or death in the absence of disease progression. DoR will be evaluated based on ICR and on investigator assessment."},{"outcome_type":"secondary","measure":"OS","time_frame":"At least 16 months","description":"OS is defined as time from date of first dose of study intervention until the date of death due to any cause"},{"outcome_type":"secondary","measure":"Tumour size change","time_frame":"An average of approximately 14 months","description":"Tumour size change will be evaluated based on ICR and investigator assessment."},{"outcome_type":"secondary","measure":"Serum concentrations of T-DXd","time_frame":"An average of approximately 14 months","description":"Individual patient data and descriptive statistics will be provided for serum concentration data at each time point for T-DXd."},{"outcome_type":"secondary","measure":"Serum concentration of total anti-HER2 antibody.","time_frame":"An average of approximately 14 months.","description":"Individual patient data and descriptive statistics will be provided for serum concentration data at each time point for total anti-HER2 antibody."},{"outcome_type":"secondary","measure":"Serum concentration of MAAA-1181a.","time_frame":"An average of approximately 14 months.","description":"Individual patient data and descriptive statistics will be provided for serum concentration data at each time point for MAAA-1181a."},{"outcome_type":"secondary","measure":"Immunogenicity","time_frame":"An average of approximately 14 months","description":"Presence of ADAs against T-DXd in serum during treatment (before infusion on Day 1 of Cycles 1, 2, and 4, and every 4 cycles thereafter) and at follow-up. Neutralising ADAs will also be assessed"},{"outcome_type":"other","measure":"Occurrence of adverse events (AEs) and serious adverse events (SAEs)","time_frame":"On average of approximately 16 months","description":"Occurrence of AEs and SAEs graded according to NCI CTCAE v5.0"}]}
{"nct_id":"NCT05033678","start_date":"2021-08-16","enrollment":8000,"brief_title":"Implementation of Teledermoscopy and Artificial Intelligence","official_title":"Teledermoscopy and Artificial Intelligence: Effects of Implementation in Clinical Practice","primary_completion_date":"2029-08-31","study_type":"Observational [Patient Registry]","rec_status":"Recruiting","completion_date":"2029-08-31","last_update":"2021-09-17","description":"The study has 2 parts. Part 1 will investigate the effects of introducing teledermoscopy in clinical practice, more specifically the change in referral patterns, the risk of undetected skin cancers and the effect on diagnostic accuracy in general practitioners. Part 2 will investigate how to introduce artificial intelligence (AI) within teledermocsopy. In this study the investigators will measure the effect of displaying the results of artificial intelligence in different ways and at different time points. Data will be collcted through teledermoscopic referrals, patient records, national registries and questionnairs.","other_id":"2020-04763","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":15,"population":"All patients, 15 years or older, seeking care for a suspected skin lesion, or when a\r\n        suspected skin lesion is detected during a visit for another complaint, and it is decided\r\n        to send a teledermoscopic consultation.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Has a skin lesion assessed by a physician during a visit\r\n\r\n          -  The physician decides to create a teledermoscopy referral\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  inability or unwillingness to participate in the study\r\n\r\n          -  the patient is younger than 15 years old\r\n      ","sponsor":"Region Skane","sponsor_type":"Other","conditions":"Skin Cancer","interventions":[{"intervention_type":"Device","name":"Device: Diagnostic algorithms","description":"Assessors of teledermoscopy will be asked to review the results of artificial intelligence displayed differently and at different time points in their assessment."}],"outcomes":[{"outcome_type":"primary","measure":"Effect on referral patterns","time_frame":"2 years","description":"Measure how referral patterns are affected by the introduction of teledermoscopy"},{"outcome_type":"primary","measure":"Effect on diagnostic accurcay in general practioners","time_frame":"2 years","description":"Measuring how the continuous use of teledermoscopy affects the diagnostic accuracy in general practitioners"},{"outcome_type":"primary","measure":"Risk of undetected skin cancer","time_frame":"2 years","description":"Measuring if the risk of undetected skin cancer increases with the use of teledermoscopy"},{"outcome_type":"primary","measure":"Effect on diagnostic accuracy due to different display of artificial intelligence","time_frame":"8 years","description":"Measuring if the diagnostic accurcy differs depending on how artificial intelligence is presented to the physician"},{"outcome_type":"primary","measure":"Artificial intelligence timing and effect on diagnostic accuracy and willingness to rethink the preliminary diagnosis","time_frame":"8 years","description":"Measuring if the diagnostic accuracy and the willingness to reconsider the preliminary diagnosis differs according to when in the process a physician is presented with the results of the artificial intelligence"}]}
{"nct_id":"NCT04749355","start_date":"2021-08-14","phase":"Phase 2","enrollment":40,"brief_title":"Phase 2, Open-Label, Single Arm Study, With BST-236 in Adults With R/R AML or Higher-Risk MDS","official_title":"A Phase 2, Open-Label, Single Arm, Multi-Center Study to Assess the Efficacy and Safety of BST-236 as a Single Agent in Adults Unfit for Intensive Chemotherapy With Relapsed or Refractory AML or Higher-Risk Myelodysplastic Syndromes","primary_completion_date":"2023-08-14","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2024-03-14","last_update":"2021-07-21","description":"An open label multi center study to assess the safety and efficacy of BST-236 as single agent in adult patients unfit for standard therapy with Acute Myeloid Leukemia (AML) or higher-risk (HR) Myelodysplastic Syndromes (MDS) who fail to respond or relapsed following first line therapy. Approximately 20 adult patients with relapsed and/or refractory AML and approximately 20 adult patients with relapsed and/or refractory HR MDS, will be enrolled into the study. Patients will be treated with 1-2 induction courses and 2-4 maintenance courses. All patients will be followed for 1 year in the study and additional 1 year post study follow-up.","other_id":"BST004","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Open-label, multi-center, single arm, single agent study","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        1. Documented diagnosis of MDS, according to World Health Organization (WHO)\r\n             classification and Revised International Prognostic Scoring System (IPSS-R) overall\r\n             score  4.5 Or\r\n\r\n             Diagnosed AML according to the 2016 revision to the WHO classification of myeloid\r\n             neoplasms and acute leukemia: 20% blasts in peripheral blood or bone marrow\r\n\r\n          2. Adult 18 years of age\r\n\r\n          3. MDS relapse following treatment with azacitidine or decitabine Or\r\n\r\n             MDS failure to achieve complete or partial response or stable disease with hematologic\r\n             improvement after at least 4 cycles of azacitidine or decitabine, all within the last\r\n             1 year Or\r\n\r\n             MDS progression while on azacitidine or decitabine treatment irrespective of the\r\n             number of cycles the patient has received Or\r\n\r\n             AML relapse after initial CR/CRi/CRh following treatment with: azacitidine,\r\n             decitabine, Low-Dose Ara-C (LDAC) , venetoclax+HMA, or venetoclax+LDAC Or\r\n\r\n             AML failure to achieve CR, CRh or CRi following at least 4 cycles of azacitidine or\r\n             decitabine or 2 cycles of venetoclax+HMA or venetoclax+LDAC within the last 1 year.\r\n\r\n             Or\r\n\r\n             AML progression while on azacitidine, decitabine, LDAC, venetoclax+HMA,\r\n             venetoclax+LDAC, irrespective of the number of cycles the patient has received.\r\n\r\n          4. Not able to receive an allogeneic bone marrow transplantation (BMT) at the time of\r\n             study enrolment.\r\n\r\n          5. Not eligible for intensive chemotherapy;\r\n\r\n               1. Age 75 years Or\r\n\r\n               2. Age 18 years with at least one of the following comorbidities:\r\n\r\n               3. Significant heart or lung comorbidities, as reflected by at least one of the\r\n                  following:\r\n\r\n               4. Left ventricular ejection fraction (LVEF) 50%\r\n\r\n               5. Lung diffusing capacity for carbon monoxide (DLCO) 65% of expected\r\n\r\n               6. Forced expiratory volume in 1 second (FEV1) 65% of expected\r\n\r\n               7. Chronic stable angina or congestive heart failure controlled with medication\r\n\r\n               8. Other comorbidity or conditions that the Investigator judges as incompatible with\r\n                  intensive chemotherapy, which must be documented\r\n\r\n               9. ECOG=2\r\n\r\n          6. Creatinine clearance (estimated by the Modification of Diet in Renal Disease (MDRD)\r\n             equation or measured by 24 hours urine collection) 45 mL/min\r\n\r\n          7. Liver enzymes (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)\r\n             2.5 times the upper limits of normal (ULN), unless attributed to leukemia (in AML\r\n             patients)\r\n\r\n          8. Total bilirubin 3 XULN unless due to Gilbert disease\r\n\r\n          9. Eastern Cooperative Oncology Group (ECOG) performance status  2\r\n\r\n         10. Women of reproductive potential must have a negative serum pregnancy test within 48\r\n             hours prior to the first day of any BST-236 treatment course\r\n\r\n         11. Women of reproductive potential must use two forms of effective birth control methods\r\n             starting from at least 1 month prior to BST-236 first dose and until 3 months\r\n             following the last BST-236 administration day (acceptable methods of birth control in\r\n             this study include: surgical sterilization, intrauterine devices, oral contraceptives,\r\n             contraceptive patch, long-acting injectable contraceptives, or double-barrier method\r\n             condom or diaphragm with spermicide)\r\n\r\n         12. Male subjects must agree to refrain from unprotected sex and sperm donation from\r\n             initial study drug administration until 3 months following the last dose of study drug\r\n\r\n         13. Subject must voluntarily sign and date an informed consent, approved by an Independent\r\n             Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of\r\n             any screening or study-specific procedures\r\n\r\n         14. Patient must be able to adhere to the study visit schedule and other protocol\r\n             requirements\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. MDS or AML evolving from a pre-existing myeloproliferative neoplasm (MPN)\r\n\r\n          2. MDS/MPN including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid\r\n             leukemia (CML), juvenile myelomonocytic leukemia (JMML) and unclassifiable MDS/MPN\r\n\r\n          3. Acute promyelocytic leukemia\r\n\r\n          4. Previous treatment for AML or MDS with drugs other than HMA or LDAC or combinations of\r\n             venetoclax with either HMA or LDAC\r\n\r\n          5. Previous allogeneic hematopoietic stem cell transplantation (HSCT) or solid organ\r\n             transplantation\r\n\r\n          6. Participation in a previous clinical trial involving use of an investigational drug\r\n             within 30 days or at least 5 half-lives of tested drug (whichever is shorter) of study\r\n             day 1\r\n\r\n          7. Peripheral White Blood Cell (WBC) count >30,000 /L in the 48 hours prior to first\r\n             BST-236 dose administration. Hydroxyurea administration or leukapheresis is permitted\r\n             to meet this criterion\r\n\r\n          8. Administration of HMA, LDAC, or venetoclax within 14 days prior to Study Day 1\r\n\r\n          9. Previous treatment with cytarabine at a dose higher than 20 mg/ m2/d\r\n\r\n         10. Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing\r\n             signs/symptoms related to the infection without improvement despite appropriate\r\n             antibiotics or other treatment)\r\n\r\n         11. Any medical or surgical condition, presence of laboratory abnormalities or psychiatric\r\n             illness that may preclude safe and complete study participation based on the\r\n             Investigator's judgment\r\n\r\n         12. Diagnosis of malignant disease (other than AML) within the previous 12 months\r\n             (excluding basal cell carcinoma of the skin without complications, \"in-situ\"\r\n             carcinoma, or other local malignancy excised or irradiated with a high probability of\r\n             cure and not treated with systemic or topical chemotherapy)\r\n\r\n         13. Surgical procedure, excluding central venous catheter placement or other minor\r\n             procedures (e.g. skin biopsy) in the 14 days prior to first BST-236 dose\r\n             administration\r\n\r\n         14. History of allergic reactions attributed to compounds of similar chemical composition\r\n             as BST-236 and/or cytarabine\r\n\r\n         15. Life expectancy shorter than 3 months attributed to any known medical condition other\r\n             than AML/MDS\r\n\r\n         16. In 12 leads ECG, corrected QT interval (QTc)>480msec or history of QT prolongation or\r\n             Torsades de pointes\r\n      ","sponsor":"BioSight Ltd.","sponsor_type":"Industry","conditions":"AML, Adult|MDS|Relapse/Recurrence|Refractory Acute Myeloid Leukemia","interventions":[{"intervention_type":"Drug","name":"Drug: BST-236","description":"BST-236 is a conjugate of cytarabine and asparagine, provided as a sterile lyophilized powder for IV administration"}],"outcomes":[{"outcome_type":"primary","measure":"CR rate","time_frame":"To be assessed 5 months after the last patient was enrolled to the study","description":"In AML patients -The proportion of patients who achieve a CR per the IWG 2006 Criteria"},{"outcome_type":"primary","measure":"Overall response rate (ORR)","time_frame":"To be assessed 5 months after the last patient was enrolled to the study","description":"In MDS patients -Overall response rate (ORR), defined as the proportion of patients who achieve a CR or PR per proposal for modification of the International Working Group (IWG) criteria for MDS, 2006"}]}
{"nct_id":"NCT04927663","start_date":"2021-08-10","phase":"Phase 1","enrollment":25,"brief_title":"11C-YJH08 PET Imaging for the Detection of Glucocorticoid Receptor Expression in Patients With Metastatic Prostate Cancer","official_title":"A First-in-Human, Phase I PET Imaging Study of 11C-YJH08, a Selective Glucocorticoid Receptor-Targeting Agent, in Patients With Advanced Solid Tumor Malignancies","primary_completion_date":"2022-10-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-10-31","last_update":"2021-08-17","description":"This phase I trial studies if positron emission tomography (PET) imaging using 11C-YJH08 can be useful for detecting certain cell receptor expression in tumor cells in patients with prostate cancer that has spread to other parts of the body (metastatic). 11C-YJH08 is a small-molecule radiotracer that binds to receptors on cells (glucocorticoid receptor) so that they show up better on the PET scan. Anti-hormone therapy (including enzalutamide) can cause more glucocorticoid receptors to be produced in tumor cells, which can make the tumor cells resist hormone therapies. If researchers can find a better way to detect whether glucocorticoid receptors are increasing during therapy, it may lead to more successful therapies using glucocorticoid receptor antagonists.","other_id":"20926","allocation":"Non-Randomized","intervention_model":"Sequential Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  COHORT A: Histologically-confirmed progressive metastatic castration resistant\r\n             prostate cancer with evidence of progression by the Prostate Cancer Clinical Trials\r\n             Working Group 3 (PCWG3) on current enzalutamide or apalutamide treatment at the time\r\n             of study entry\r\n\r\n          -  COHORT B: Metastatic castration-resistant prostate cancer with planned treatment with\r\n             enzalutamide or apalutamide as next line of systemic therapy at the time of study\r\n             entry. Patients must not have received first dose of enzalutamide or apalutamide prior\r\n             to baseline 11C-YJH08 PET\r\n\r\n          -  Patients in Cohort A and B must have serum testosterone level < 50 ng/dL and must\r\n             remain on luteinizing hormone-releasing hormone (LHRH) analog therapy for the duration\r\n             of study participation, in the absence of prior bilateral orchiectomy\r\n\r\n          -  The subject is able and willing to comply with study procedures and provide signed and\r\n             dated informed consent\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\r\n\r\n          -  Age 18 years or older at the time of study entry\r\n\r\n          -  Serum creatinine =< 1.5 x upper limit of normal (ULN) OR estimated creatinine\r\n             clearance > 50 ml/min\r\n\r\n          -  Total bilirubin =< 1.5 x ULN\r\n\r\n          -  Hemoglobin >= 8.0 g/dL\r\n\r\n          -  Platelet count >= 50,000/microliter\r\n\r\n          -  Absolute neutrophil count >= 1000/microliter\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who because of age, general medical or psychiatric condition, or physiologic\r\n             status cannot give valid informed consent\r\n\r\n          -  Concurrent treatment with any dose of systemic glucocorticoids within 7 days prior to\r\n             cycle 1 day 1 (C1D1)\r\n\r\n          -  History of adrenal insufficiency requiring use of systemic glucocorticoid replacement\r\n\r\n          -  History of Cushing's disease or Cushing's syndrome\r\n\r\n          -  Any condition that, in the opinion of the principal investigator, would impair the\r\n             patient's ability to comply with study procedures\r\n\r\n          -  Contra-indication to MRI (e.g. pacemaker placement, severe claustrophobia) (applicable\r\n             only for patients scheduled for PET/MRI)\r\n      ","sponsor":"Michael Evans","sponsor_type":"Other","conditions":"Castration-Resistant Prostate Carcinoma|Metastatic Prostate Carcinoma|Stage IV Prostate Cancer AJCC v8|Stage IVA Prostate Cancer AJCC v8|Stage IVB Prostate Cancer AJCC v8","interventions":[{"intervention_type":"Procedure","name":"Procedure: Positron Emission Tomography","description":"Undergo PET imaging"},{"intervention_type":"Drug","name":"Drug: 11C-YJH08","description":"Given IV"},{"intervention_type":"Procedure","name":"Procedure: Computed Tomography","description":"Undergo CT imaging"},{"intervention_type":"Procedure","name":"Procedure: Magnetic Resonance Imaging","description":"Undergo MRI"}],"outcomes":[{"outcome_type":"primary","measure":"Sensitivity of 11C-YJH08 PET in metastatic lesion detection (Cohort A only)","time_frame":"Up to day 1 follow-up","description":"Will be descriptively reported on a lesion-per-lesion basis, using as reference standard staging scans including computed tomography or magnetic resonance imaging of the chest/abdomen/pelvis and whole body bone scan."},{"outcome_type":"primary","measure":"Mean percent change from baseline at the time of progression in standardized uptake value (SUV)max-ave on paired 11C-YJH08 PET per-patient basis (Cohort B only)","time_frame":"Up to 24 months","description":"Will be descriptively reported along with range on a per-patient basis. Wilcoxon signed rank test will be used to compare the follow up to baseline PET scan values at patient level."},{"outcome_type":"primary","measure":"Mean percent change from baseline at the time of progression in standardized uptake value (SUV)max-ave on paired 11C-YJH08 PET per-lesion (Cohort B only)","time_frame":"Up to 24 months","description":"Will be descriptively reported along with range on a per-lesion basis. Wilcoxon signed rank test will be used to compare the follow up to baseline PET scan values at lesion level."},{"outcome_type":"secondary","measure":"Incidence of adverse events","time_frame":"Up to day 1 follow-up","description":"As recorded by Common Terminology Criteria for Adverse Events Version 5.0 criteria and organ dosimetry of 11C-YJH08 PET. Will be descriptively reported."},{"outcome_type":"secondary","measure":"Descriptive patterns of intra-tumoral uptake of 11C-YJH08 on whole body PET","time_frame":"Up to 24 months","description":"Including by site of disease, uptake by tumor type, inter-tumoral and interpatient heterogeneity, and tumor-to-background signal."},{"outcome_type":"secondary","measure":"Association between baseline uptake on 11C-YJH08 PET and objective response rate (Cohort B only)","time_frame":"Up to 24 months","description":"Will be compared between dichotomized groups using the chi-squared test."},{"outcome_type":"secondary","measure":"Association between baseline uptake on 11C-YJH08 PET with progression-free survival (Cohort B only)","time_frame":"Up to 24 months","description":"The log rank test will be used to compare progression-free survival between dichotomized subgroups."},{"outcome_type":"secondary","measure":"Association between baseline uptake on 11C-YJH08 PET with prostate specific antigen (PSA50) response (Cohort B only)","time_frame":"Up to 24 months","description":"Will be compared between dichotomized groups using the chi-squared test."}]}
{"nct_id":"NCT04470024","start_date":"2021-08-05","phase":"Phase 1","enrollment":56,"brief_title":"Phase Ib Trial of Multivalent Autophagosome Vaccine With or Without GITR Agonist, With Anti-PD-1 Immunotherapy in HNSCC","official_title":"A Phase Ib Study of Multivalent Autophagosome Vaccine, With or Without GITR Agonist, With Sequenced Checkpoint Inhibition (Anti-PD-1) - Immunotherapy Trio in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)","primary_completion_date":"2023-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2024-07-31","last_update":"2021-09-10","description":"This is a phase Ib study with a safety lead-in (n = 6 per arm) evaluating combinatorial DPV-001 + sequenced PD-1 blockade, with or without GITR agonist, in recurrent or metastatic HNSCC.","other_id":"2020000480","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"The trial will have a run-in safety phase for each of the 2 arms, starting with arm 1 using a standard 3+3 design. If arm 1 is deemed safe, the safety run-in for arm 2 will begin enrollment, using the same 3+3 design. If arm 2 is deemed safe, enrollment will continue to 15 in each arm (total n = 30). Patients enrolling after the safety run-in will be randomly assigned to either arm 1 or arm 2.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 (Appendix C)\r\n\r\n          -  Age 18 years or above.\r\n\r\n          -  Laboratory values:\r\n\r\n          -  WBC 2000/uL\r\n\r\n          -  Hgb >8.0 g/dl (patients may be transfused to reach this level)\r\n\r\n          -  Platelets >75,000 cells/mm3\r\n\r\n          -  Serum creatinine clearance  50 mL/min measured or calculated by Cockcroft-Gault (C-G)\r\n             equation\r\n\r\n          -  Negative bHCG (urine/serum) Women of childbearing potential only\r\n\r\n          -  AST (SGOT) and ALT (SGPT) 2.5  upper limit of laboratory normal (ULN) OR  5  ULN\r\n             for participants with liver metastases\r\n\r\n          -  Alkaline phosphatase 2.5  ULN OR  5  ULN for participants with liver metastases\r\n\r\n          -  Total bilirubin 1.5  ULN. If total bilirubin is >1.5, conjugated bilirubin must be \r\n             ULN (conjugated bilirubin only needs to be tested if total bilirubin exceeds ULN). If\r\n             there is no institutional ULN, then conjugated bilirubin must be < 40% of total\r\n             bilirubin.\r\n\r\n          -  Patients positive for hepatitis B core antibody (anti-HBc, total), are eligible only\r\n             if HBV DNA is non-detectable by qPCR.\r\n\r\n          -  Patients positive for hepatitis C virus (HCV) antibody are eligible only if HCV RNA is\r\n             non-detectable by qPCR.\r\n\r\n          -  Patients positive for HIV 1/2 antibodies, are eligible if ARV treatment compliant with\r\n             documented stable CD4 > 300 for at least 6 months and undetectable viral load\r\n\r\n          -  Ability to give informed consent and comply with the protocol.\r\n\r\n          -  Anticipated lifespan greater than 12 weeks.\r\n\r\n          -  Women of childbearing potential must have negative serum/urine pregnancy test <5 days\r\n             prior to start of study.\r\n\r\n          -  Males and women of childbearing potential, must agree to take appropriate precautions\r\n             to avoid pregnancy during treatment and through 180 days after last dose of study\r\n             treatment (see Appendix A).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Concurrent enrollment in another clinical study, unless it is an observational\r\n             (non-interventional) clinical study or during the follow-up period of an\r\n             interventional study.\r\n\r\n          -  Receipt of any investigational anticancer therapy during the last 28 days or 5\r\n             half-lives, whichever is shorter, prior to the first dose of study treatment.\r\n\r\n          -  Any concurrent chemotherapy, investigational agent, biologic, or hormonal therapy for\r\n             cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions\r\n             (e.g., hormone replacement therapy) is acceptable.\r\n\r\n          -  Local treatment of isolated lesions for palliative intent is acceptable (e.g., local\r\n             surgery or radiotherapy), excluding target lesions, Palliative radiation therapy\r\n             cannot be administered less than 1 week prior to the first dose of study treatment.\r\n\r\n          -  Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of\r\n             radiation within 4 weeks of the first dose of study drug.\r\n\r\n          -  Radiation therapy in the thoracic region that is > 30 Gy within 6 months of the first\r\n             dose of study treatment. Note: Participants must have recovered from all\r\n             radiation-related toxicities, not require corticosteroids for this purpose, and not\r\n             have had radiation pneumonitis.\r\n\r\n          -  Major surgical procedure (as defined by the Investigator) within 28 days prior to the\r\n             first dose of study treatment. Note: Local surgery of isolated lesions for palliative\r\n             intent is acceptable.\r\n\r\n          -  History of organ transplant, including allogeneic stem cell transplantation.\r\n\r\n          -  Uncontrolled intercurrent illness as deemed by the investigator, including but not\r\n             limited to, ongoing or active infection, symptomatic congestive heart failure,\r\n             uncontrolled hypertension, unstable angina pectoris, unstable cardiac arrhythmia,\r\n             interstitial lung disease or history of, serious chronic gastrointestinal conditions\r\n             associated with diarrhea, active noninfectious pneumonitis, or psychiatric\r\n             illness/social situations that would limit compliance with study requirement,\r\n             substantially increase risk of incurring AEs or compromise the ability of the patient\r\n             to give written informed consent.\r\n\r\n          -  History of another primary malignancy except for:\r\n\r\n               -  Malignancy treated with curative intent and with no known active disease 1.5\r\n                  years before the first dose of investigational product and of low potential risk\r\n                  for recurrence\r\n\r\n               -  Adequately treated non-melanoma skin cancer or lentigo maligna without evidence\r\n                  of disease\r\n\r\n               -  Adequately treated carcinoma in situ without evidence of disease\r\n\r\n          -  History of leptomeningeal carcinomatosis\r\n\r\n          -  Has untreated central nervous system (CNS) metastases and/or carcinomatous meningitis.\r\n             Patients whose brain metastases have been treated may participate provided they show\r\n             radiographic stability (imaging at least four weeks apart showing no evidence of\r\n             intracranial progression). In addition, any neurologic symptoms that developed either\r\n             as a result of the brain metastases or their treatment must have resolved or be stable\r\n             either, without the use of steroids, or are stable on a steroid dose of 10mg/day of\r\n             prednisone or its equivalent and anti-seizure medications for at least 14 days prior\r\n             to the start of treatment. Patients on a stable dose of seizure medicines for epilepsy\r\n             unrelated to cancer are eligible for the trial.\r\n\r\n          -  History of active primary immunodeficiency.\r\n\r\n          -  Active tuberculosis infection (clinical evaluation that includes clinical history,\r\n             physical examination and radiographic findings, and TB testing in line with local\r\n             practice).\r\n\r\n          -  Active autoimmune disease requiring systemic immunosuppression in excess of\r\n             physiologic maintenance doses of corticosteroids (> 10 mg/day of prednisone or\r\n             equivalent).:\r\n\r\n               -  Physiologic corticosteroid replacement therapy at doses > 10 mg/day of prednisone\r\n                  or equivalent for adrenal or pituitary insufficiency and in the absence of active\r\n                  autoimmune disease is permitted.\r\n\r\n               -  Participants with asthma that requires intermittent use of bronchodilators,\r\n                  inhaled steroids, or local steroid injections may participate.\r\n\r\n               -  Participants using topical, ocular, intra-articular, or intranasal steroids (with\r\n                  minimal systemic absorption) may participate.\r\n\r\n               -  Brief courses of corticosteroids for prophylaxis (eg, contrast dye allergy) or\r\n                  study treatment-related standard premedication are permitted.\r\n\r\n          -  Receipt of live attenuated vaccine within 28 days prior to the first dose of study\r\n             treatment. Note: patients should not receive live vaccine during study treatment and\r\n             up to 30 days after the last dose of study treatment.\r\n\r\n          -  Known allergy or hypersensitivity to study drug(s) or compounds of similar biologic\r\n             composition to the study drug(s), or any of the study drug excipients.\r\n\r\n          -  Any unresolved NCI CTCAE Grade 2 toxicities from prior anti-cancer therapy with the\r\n             exception of vitiligo, alopecia, and the laboratory values defined in the inclusion\r\n             criteria.\r\n\r\n          -  Patients with Grade 2 neuropathy will be evaluated on a case-by-case basis after\r\n             consultation with the Principal Investigator or one of the Co-Principal Investigators.\r\n\r\n          -  Patients with irreversible toxicity not reasonably expected to be exacerbated by study\r\n             treatment may be included only after consultation with the Principal Investigator or\r\n             one of the Co-Principal Investigators.\r\n\r\n          -  Immune-related toxicity during prior checkpoint inhibitor therapy for which permanent\r\n             discontinuation of therapy is recommended (per product label or consensus guidelines)\r\n             OR\r\n\r\n          -  any immune-related toxicity requiring intensive or prolonged immunosuppression to\r\n             manage (with the exception of endocrinopathy that is well controlled on replacement\r\n             hormones).\r\n\r\n          -  Receipt of systemic antibiotics  7 days prior to the first dose of study drug.\r\n      ","sponsor":"Providence Health & Services","sponsor_type":"Other","conditions":"Cancer of the Head and Neck","interventions":[{"intervention_type":"Drug","name":"Drug: INCAGN01876","description":"agonistic antihuman GITR mAb"},{"intervention_type":"Drug","name":"Drug: INCMGA00012","description":"humanized, hinge-stabilized, IgG4 mAb that recognized human PD-1"},{"intervention_type":"Biological","name":"Biological: DPV-001","description":"autophagosome cancer vaccine"}],"outcomes":[{"outcome_type":"primary","measure":"Adverse Events Assessment","time_frame":"from time of informed consent through 90 days after the last study treatment","description":"frequency, duration, and severity of adverse events"},{"outcome_type":"secondary","measure":"ORR, DOR, DCR","time_frame":"week 12, 24, and every 12 weeks thereafter","description":"Determined by investigator assessment per RECIST v1.1"},{"outcome_type":"secondary","measure":"Overall survival (OS)","time_frame":"1 year, 2 years, and study completion","description":"Determined from the start of combination until death due to any cause"},{"outcome_type":"secondary","measure":"Duration of disease control","time_frame":"week 12, 24, and every 12 weeks thereafter","description":"Measured from first report of SD or better (per RECIST v1.1) until PD or death"}]}
{"nct_id":"NCT04944212","start_date":"2021-08-05","enrollment":400,"brief_title":"Prevalence of Vitamin D Deficiency in Pregnant Women and Their Fetus in North Jordan","official_title":"Prevalence of Vitamin D Deficiency in Pregnant Women and Their Newborns and Their Association With Maternal and Newborns Characteristics","primary_completion_date":"2022-01-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2022-01-31","last_update":"2021-08-10","description":"In Jordan, there are few data about the prevalence of hypovitaminosis D in pregnant women and their newborns and factors that affect their levels. Hence, in this study, investigators will : 1. Determine vitamin D levels among newborns born in north Jordan 2. Determine vitamin D levels among pregnant women in north Jordan 3. Study the association between maternal and infants levels of vitamin D 4. Explore the association between maternal and fetal characteristics and maternal and/or fetal vitamin D level 5. Study the effect of low fetal vitamin D on newborn anthropometry 6. Study the effect of maternal vitamin D supplement use during pregnancy in raising cord serum vitamin D levels","other_id":"39/131/2020","observational_model":"Other","time_perspective":"Cross-Sectional","sampling_method":"Probability Sample","gender":"All","population":"Pregnant women with singleton live fetuses who attended to labour ward","criteria":"\n        Inclusion Criteria:\r\n\r\n        All pregnant women who attend to labour ward with singleton alive pregnancies\r\n\r\n        Exclusion Criteria:\r\n\r\n        women with multiple pregnancies or with dead fetuses\r\n      ","sponsor":"Jordan University of Science and Technology","sponsor_type":"Other","conditions":"Vitamin D Deficiency","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Measuring vitamin D serum level using ELIZA","description":"Venous blood will be obtained from pregnant women at the time of admission and from the umbilical cord veins of the newborns immediately after their delivery. The quantitative measurement of 25OHD in serum will be performed using ELIZA."}],"outcomes":[{"outcome_type":"primary","measure":"Determine maternal and fetal vitamin D level among pregnant women and their newborns in north Jordan","time_frame":"5 minutes","description":"Measurement of vitamin D using ELIZA"},{"outcome_type":"secondary","measure":"Study the association between maternal and infants levels of vitamin D. Study factors that affect maternal and fetal vitamin D level","time_frame":"5 months","description":"Both are measured using ELIZA"}]}
{"nct_id":"NCT05002803","start_date":"2021-08-04","phase":"N/A","enrollment":10,"brief_title":"The Development and Validation of the Arabic Otago Exercise Program","official_title":"The Development and Validation of the Arabic Otago Exercise Program: A Feasibility Pilot Randomized Controlled Trial","primary_completion_date":"2021-10-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-12-31","last_update":"2021-08-12","description":"Falls are common in older adults and may lead to disability or even death. Therefore, exercise programs that focus on preventing falls by improving strength and balance are important to investigate in older adults. One of the home-based exercise programs that was found effective in reducing the risk of falling and the rate of subsequent falls in older adults is the Otago exercise program (OEP). The OEP is an individualized home based retraining program that works mainly on balance and lower extremity strength through several progressive resistive exercises. The OEP is available in English language since late 1990. However, its use in the Arabic-speaking countries is limited due to the language barrier. Therefore, translating such a program to the Arabic language would facilitate its use among Arabic-speaking older adults. Therefore, this study aims: - To translate the Otago Exercise Program (OEP) into the Arabic language. - To assess the feasibility of the Arabic OEP in a pilot sample of Arabic-speaking older adults.","other_id":"2021/134","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adults who are 60 years of age and older.\r\n\r\n          -  Who can read and write in Arabic language.\r\n\r\n          -  Who are able to walk outdoors with no more support than a single point cane.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Who have a serious orthopedic condition (e.g., recent lower limb surgery, severe\r\n             arthritis of a lower limb) or major neurological disorder (e.g., stroke with\r\n             unilateral or bilateral paresis, Parkinson disease or multiple sclerosis) that could\r\n             restrict functional mobility.\r\n\r\n          -  Who are unable to comprehend study information and consent processes due to any\r\n             illness including dementia.\r\n      ","sponsor":"University of Jordan","sponsor_type":"Other","conditions":"Older Adults","interventions":[{"intervention_type":"Other","name":"Other: Otago Exercise Program","description":"A Home-based Exercise Program to improve strength and balance and prevent falls."}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of falls","time_frame":"2 months post intervention.","description":"The effect of the intervention on the incidence of falls."},{"outcome_type":"secondary","measure":"Fear of Falling (using the Falls Efficacy Scale-International)","time_frame":"2 months post intervention.","description":"The effect of the intervention on fear of falling. The total score ranges between 16 and 64 with a higher score indicates greater fear of falling (worse)."},{"outcome_type":"secondary","measure":"Balance (using Chair balance test and Four test balance scale)","time_frame":"2 months post intervention.","description":"The effect of the intervention on balance. The time taken to conduct these balance tasks are timed using a stopwatch. The longer the time taken by the participant to perform the tasks, the worse the balance. There is no minimum or maximum scores for these tests."},{"outcome_type":"secondary","measure":"Mobility (using Timed-Up and go)","time_frame":"2 months post intervention.","description":"The effect of the intervention on mobility. This assessments of mobility is timed out using a stopwatch."},{"outcome_type":"secondary","measure":"Muscle strength (Hand grip and Quadriceps muscle strength using a dynamometer)","time_frame":"2 months post intervention.","description":"The effect of the intervention on upper and lower extremity muscle strength. The strength of Hand grip and Quadriceps muscle will be assessed using a dynamometer in kilograms."},{"outcome_type":"secondary","measure":"The Quality of Life (using Medical Outcomes Study Short Form 12)","time_frame":"2 months post intervention.","description":"The effect of the intervention on Quality of Life. The total score ranges between 0% to 100% with higher score indicates a better quality of life (better)."}]}
{"nct_id":"NCT04978675","start_date":"2021-08-04","phase":"Phase 1","enrollment":25,"brief_title":"An Investigational Scan (rh PSMA 7.3 PET/MRI) for the Detection of Recurrent Disease and Aid in Radiotherapy Planning in Biochemically Recurrent Prostate Cancer","official_title":"A Prospective Pilot Study Investigating rhPSMA 7.3 PET/MRI in Detecting Recurrent Disease and Aid in Radiotherapy Planning in Patients With Biochemically Recurrent Prostate Cancer","primary_completion_date":"2023-04-28","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-04-28","last_update":"2021-08-26","description":"This prospective pilot study will assess the feasibility of rh PSMA 7.3 positron emission tomography/magnetic resonance imaging (PET/MRI) scans in detecting prostate cancer that may have come back (recurrent) in patients with increasing levels of prostate-specific antigen (PSA) following prostate surgery (biochemically recurrent). An increase in PSA levels alone does not tell the doctor where the cancer may be or how much cancer there may be. Imaging tests, like a bone scan, MRI, and/or computed tomography, are often performed to help the doctor learn where or how much cancer there is, and how best to treat the cancer. rhPSMA-7.3 is a radioactive tracer agent that when used with PET/MRI imaging may help diagnose and look for the spread of prostate cancer. Prostate-specific membrane antigen (PSMA) is a protein that is expressed in prostate cancer and this agent targets the PSMA molecule. Giving rh PSMA 7.3 during PET/MRI may help doctors better find where the cancer may be spreading and how much of it there is. The results of this trial may also guide in radiotherapy planning.","other_id":"2020-1347","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patient is male and aged > 18 years old\r\n\r\n          -  History of localized adenocarcinoma of the prostate status post (s/p) radical\r\n             prostatectomy\r\n\r\n          -  An initial elevated PSA >= 0.2 followed by a subsequent confirmatory PSA >= 0.2\r\n             clinically suspicious for biochemically recurrent disease\r\n\r\n          -  If the patients were previously taking androgen deprivation therapy (ADT), it should\r\n             be discontinued at least 12 weeks prior to the study\r\n\r\n          -  Patient willing to provide signed informed consent and willing to comply with all\r\n             required study schedule events, where safe and feasible\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with any medical condition or circumstance that the investigator believes may\r\n             compromise the data collected or lead to a failure to fulfil the study requirements\r\n\r\n          -  Patients who are planned to have an Iodinated contrast agent with computed tomography\r\n             (CT) or gadolinium based contrast agent with MRI or other PET radiotracer < 24 hours\r\n             prior to the PET scan\r\n\r\n          -  Patients with contraindication to undergo MRI\r\n\r\n          -  Patients with extreme claustrophobia\r\n\r\n          -  Patients with prior allergy to MRI contrast agent\r\n      ","sponsor":"M.D. Anderson Cancer Center","sponsor_type":"Other","conditions":"Biochemically Recurrent Prostate Carcinoma|Localized Prostate Carcinoma|Prostate Adenocarcinoma","interventions":[{"intervention_type":"Drug","name":"Drug: Fluorine F 18 rhPSMA-7.3","description":"Given IV"},{"intervention_type":"Procedure","name":"Procedure: Magnetic Resonance Imaging","description":"Undergo PET/MRI"},{"intervention_type":"Procedure","name":"Procedure: Positron Emission Tomography","description":"Undergo PET/MRI"}],"outcomes":[{"outcome_type":"primary","measure":"Positive predictive value (PPV) of F-18 rhPSMA-7.3 positron emission tomography/magnetic resonance imaging (PET/MRI) in detecting recurrent disease","time_frame":"Up to 6 months","description":"Will be evaluated on both a per-patient and per-region basis. Will estimate the PPV rate and corresponding 95% confidence interval."},{"outcome_type":"secondary","measure":"Detection rate","time_frame":"Up to 6 months","description":"Defined as the proportion of patients with prostate-specific membrane antigen (PSMA) positive results. The association between detection and prostate specific antigen level will be assessed by Wilcoxon rank-sum tests."},{"outcome_type":"secondary","measure":"Change in salvage radiation treatment plan","time_frame":"Baseline up to 6 months","description":"The proportion of patients with major and minor changes will be summarized."}]}
{"nct_id":"NCT04813120","start_date":"2021-08-01","phase":"N/A","enrollment":80,"brief_title":"Digital Mirror Therapy With Uni- and Bilateral Mirror Visual Feedback After Stroke: Treatment Effects and EEG Evidence","official_title":"The Use of a New Digital Mirror Therapy System Providing Unilateral and Bilateral Mirror Visual Feedback for Patients With Stroke: Treatment Effects and EEG-physiological Evidence","primary_completion_date":"2024-07-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2024-07-31","last_update":"2021-03-24","description":"The specific study aims will be: 1. To examine the treatment effects of a new digital mirror therapy (MT) system versus a mirror box in patients with stroke by conducting a 4-group randomized controlled trial. 2. To examine the electrophysiological mechanisms of uni-mirror visual feedback (uni-MVF) condition with unimanual training mode, uni-MVF condition with bimanual training mode, and bi-MVF condition with bimanual training mode in the new MT system by EEG.","other_id":"202002234A3","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":80,"population":"","criteria":"\n        Part : Validation of Treatment Efficacy of the New Digital MT System with Different MVF\r\n        Conditions and Training Modes\r\n\r\n        Inclusion Criteria:\r\n\r\n          -  diagnosed with a unilateral stroke;\r\n\r\n          -  at least 6 months after stroke onset;\r\n\r\n          -  age between 20 and 80 years old;\r\n\r\n          -  having a baseline score of Fugl-Meyer Assessment (FMA) in a range of 20 to 60;\r\n\r\n          -  able to follow the study instructions;\r\n\r\n          -  capable of participating in therapy and assessment sessions\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  global or receptive aphasia;\r\n\r\n          -  severe neglect measured by line bisection test;\r\n\r\n          -  other major medical diseases or comorbidities that have influenced upper-limb usage or\r\n             caused severe pain\r\n\r\n        Part II: Investigation of the Electrophysiological Mechanisms Underlying Different MVF\r\n        Conditions by EEG\r\n\r\n        Inclusion Criteria:\r\n\r\n          -  diagnosed with a unilateral stroke;\r\n\r\n          -  at least 2 weeks after stroke onset and medical stable;\r\n\r\n          -  aged 20 to 80 years;\r\n\r\n          -  having a baseline score of FMA  40 and wrist flexion  20 degrees in order to perform\r\n             EEG motor tasks;\r\n\r\n          -  both wrist flexion and extension scores of Modified Ashworth Scale  1;\r\n\r\n          -  able to follow the study instructions\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  global or receptive aphasia;\r\n\r\n          -  severe neglect measured by line bisection test;\r\n\r\n          -  other major medical diseases or comorbidities, such as neurological and psychiatric\r\n             diseases, that have caused severe pain of upper-limb or interfered brain neural\r\n             activities\r\n      ","sponsor":"Chang Gung Memorial Hospital","sponsor_type":"Other","conditions":"Stroke|Cerebrovascular Disorders|Central Nervous System Diseases","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Uni-MVF condition and unimanual training mode using the new MT system (UM-UT)","description":"For the UM-UT group, the participants will be seated in front of the new MT system, and will be instructed to watch the real-time image reflection of movements of the non-affected arm and hand on the screen carefully. At the same time, the patients will need to imagine that the movements were performed by their affected arm and hand. In this group, only the non-affected arm and hand will need to perform the movements, but the affected one will not need to move."},{"intervention_type":"Behavioral","name":"Behavioral: Uni-MVF condition and bimanual training mode using the new MT system (UM-BT)","description":"During the UM-BT, as similar as the first group (UM-UT), the participants will be also seated in front of the new MT system, and be instructed to watch the real-time image reflection of the non-affected arm and hand's movements on the screen carefully and imagine that the movements were performed by the affected arm. However, in this UM-BT group, the bilateral training mode is emphasized, and thus both arms and hands will need to move. That is, during therapy, the patient's affected arm and hand will be required to move at his/her best motor ability with the non-affected arm and hand at the same time."},{"intervention_type":"Behavioral","name":"Behavioral: Bi-MVF condition and bimanual training mode using the new MT system (BM-BT)","description":"For the BM-BT group, the participants will be seated in front of this new MT system, and be instructed to observe the real-time image reflection of the non-affected arm and hand's movements transformed and superimposed on both arms and hands (i.e., bi-MVF), and to imagine that the movements were performed by both arms and hands. In this group, bi-MVF and bilateral training mode are emphasized, and thus both arms and hands will also need to move. The patient's affected arm and hand will be required to move as could as possible simultaneously."},{"intervention_type":"Behavioral","name":"Behavioral: Traditional MT using a mirror box","description":"During traditional MT, the participants will be seated in front of a mirror box placed at their mid-sagittal plane. The affected arm and hand of the participants will be placed inside the mirror box, and the non-affected arm and hand will be in front of the mirror. As similar to the UM-UT group, the participants will be instructed to watch the mirror reflection of the movements performed by the non-affected arm and hand carefully and to imagine that the movements were performed by the aected arm and hand. In this group, the patient's affected arm and hand inside the mirror box will not need to move."}],"outcomes":[{"outcome_type":"primary","measure":"Change scores of Fugl-Meyer Assessment","time_frame":"baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)","description":"The upper-limb subsection of Fugl-Meyer Assessment is a measure with sound psychometric properties to evaluate motor impairments."},{"outcome_type":"primary","measure":"Change scores of Chedoke Arm and Hand Activity Inventory","time_frame":"baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)","description":"The Chedoke Arm and Hand Activity Inventory is a reliable and validated measure to assess the independence of stroke patients to perform activities of daily living with an affected upper limb."},{"outcome_type":"secondary","measure":"change scores of Box and Block Test","time_frame":"baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)","description":"The Box and Block Test is a tool with sound reliability and validity to evaluate hand dexterity of stroke patients."},{"outcome_type":"secondary","measure":"change scores of Revised Nottingham Sensory Assessment","time_frame":"baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)","description":"The Revised Nottingham Sensory Assessment is a standardized measure with good reliability to assess sensory function in patients with stroke."},{"outcome_type":"secondary","measure":"change scores of Movement Imagery Questionnaire-Revised, Second Edition","time_frame":"baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)","description":"The Movement Imagery Questionnaire-Revised, Second Edition is a 14-item questionnaire with sound reliability and validity to evaluate the ability of motion imagination in patients with stroke."},{"outcome_type":"secondary","measure":"change scores of Barthel Index","time_frame":"baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)","description":"The Barthel Index is a validated tool designed to measure activities reflecting the daily living independence."},{"outcome_type":"secondary","measure":"change scores of Motor Activity Log","time_frame":"baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)","description":"The Motor Activity Log is a semi-structured interview with good psychometric properties to assess the level of use of affected upper limb in 30 main activities of daily living."},{"outcome_type":"secondary","measure":"change scores of the health state of EQ-5D-5L","time_frame":"baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)","description":"The questionnaire of EQ-5D-5L contains 5 dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and uses a 5-point Likert scale scored from 1 (no problem) to 5 (unable to/extreme problems); whereas, the numerical description of 5 dimensions represents the health state."},{"outcome_type":"secondary","measure":"change scores of the visual analogue scale (VAS) of EQ-5D-5L","time_frame":"baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)","description":"The VAS of EQ-5D-5L scores will be scored from 0 to 100, with a higher score indicating better overall current health."}]}
{"nct_id":"NCT04938167","start_date":"2021-08-01","phase":"N/A","enrollment":30,"brief_title":"Preductal Oxygen Saturation Target in Term and Late Preterm Neonates With Hypoxemic Respiratory Failure or Pulmonary Hypertension","official_title":"Preductal Oxygen Saturation Target in Term and Late Preterm Neonates With Hypoxemic Respiratory Failure or Pulmonary Hypertension (POST-IT)","primary_completion_date":"2023-08-01","study_type":"Interventional","rec_status":"Enrolling by invitation","completion_date":"2024-02-01","last_update":"2021-08-19","description":"The purpose of this research is to evaluate two oxygen saturation goals for newborns with pulmonary hypertension. Participation in this research will involve random assignment to one of two oxygen saturation goals, review of the medical record and targeted echocardiograms.","other_id":"1766675","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Randomized assignment to Standard arm (target preductal SpO2 91% to 95%) or Intervention arm (target preductal SpO2 95% to 99%)","sampling_method":"","gender":"All","maximum_age":0.07671,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Corrected gestational age (postmenstrual age) > 34 6/7 weeks\r\n\r\n          -  postnatal age  28 d\r\n\r\n          -  on respiratory support with invasive mechanical ventilation, non-invasive ventilation,\r\n             CPAP or high flow nasal cannula (defined as flow rates  2 LPM with a humidifier),\r\n             inspired oxygen concentration, FiO2  0.3\r\n\r\n          -  and echocardiography shows any finding suggestive of PH (or score > 0 for PH in table\r\n             2).\r\n\r\n          -  Infants with congenital diaphragmatic hernia (CDH), Down syndrome, hypoxic ischemic\r\n             encephalopathy (HIE) on therapeutic hypothermia and patent ductus arteriosus (PDA),\r\n             patent foramen ovale/atrial septal defect (PFO/ASD) and ventricular septal defect\r\n             (VSD) (single or multiple) < 2 mm can be included in the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  < 32 weeks gestation at birth (31 6/7 or lower)\r\n\r\n          -  Weight < 2000 g at the time of enrollment\r\n\r\n          -  Severe HRF with OI > 35 or SpO2 < 75% on FiO2 = 1.0 on mechanical ventilation for > 60\r\n             minutes in spite of correction of reversible factors such as pneumothorax\r\n\r\n          -  A condition or congenital anomaly known to be lethal (high likelihood of death during\r\n             infancy) - e.g., trisomy 18 or trisomy 13\r\n\r\n          -  Congenital heart disease other than ASD/PFO, PDA or VSD (single or multiple defects) <\r\n             2 mm.\r\n      ","sponsor":"University of California, Davis","sponsor_type":"Other","conditions":"Persistent Pulmonary Hypertension of the Newborn|Hypoxemic Respiratory Failure","interventions":[{"intervention_type":"Other","name":"Other: 95% - 99% SpO2 target","description":"If the infant is randomized to the intervention arm, the oxygen saturation goal will be changed from the standard goal of 91% - 95% to the experimental goal of 95%-99%. The treating medical team will then adjust the oxygen and respiratory support to maintain these goals (SpO2 alarm levels will be set at 93% and 100%)."}],"outcomes":[{"outcome_type":"primary","measure":"Hypoxemic Respiratory Failure and Pulmonary Hypertension (HRF/PH) score","time_frame":"At enrollment","description":"Most randomized trials evaluating PPHN have taken oxygenation, echocardiographic evidence of PH or survival with extracorporeal membrane oxygenation (ECMO) as primary endpoints. Oxygenation was primarily assessed with postductal arterial gases. More recently, preductal SpO2 and blood gases have been shown to have advantages during management of PPHN with congenital diaphragmatic hernia (CDH). Given the low need for ECMO in PPHN (other than due to CDH), the investigators have developed a HRF/PH score combining oxygenation using preductal SpO2 and echocardiographic parameters. The score ranges from 0 to 15, with a higher score corresponding to worse respiratory failure or pulmonary hypertension. The primary aim of this pilot trial to understand the variation of this score at two oxygen saturation targets and assess its reliability and validity."},{"outcome_type":"primary","measure":"Correlation of the Oxygenation and Echocardiography components of the HRF/PH scores","time_frame":"At enrollment"},{"outcome_type":"secondary","measure":"Intracluster correlation coefficients of the HRF/PH score","time_frame":"Days 3-7","description":"The investigators will fit a sequence of two-level multilevel models to estimate intracluster correlation coefficients based on the between-infant (level 2) and other relevant variance component(s), after adjusting for fixed effects, including study arm and sex. Interrater reliability at specific days will be estimated by having two or more raters (level 1) score each infant's underlying oxygenation and echocardiography measurements, while within-infant, over-time intracluster correlation will be estimated by analyzing a data set with one score per infant per day (level 1), with fixed effects added to account for day effects and possibly restricted to a smaller number of the later days (e.g. days 3 to 7), in case early-day values are grossly unstable."},{"outcome_type":"secondary","measure":"Preliminary estimates of intervention effects on outcomes (length of stay, duration of mechanical ventilation, and ECMO)","time_frame":"Day 7","description":"For obtaining preliminary estimates of intervention effects on Day-7 HRF/PH, the investigators will use the results of Outcome 1 to inform our choice of how best to account for the baseline HRF/PH score, although the investigators anticipate that the within-infant correlation will be suitably modest that ANCOVA-like approaches will be preferred over differences-in-differences. Intervention effects and other regression-parameters will be estimated with robust 95% confidence intervals, to ensure accurate coverage."}]}
{"nct_id":"NCT04798898","start_date":"2021-08-01","phase":"N/A","enrollment":200,"brief_title":"Improving Survival of COlorectal LIver Metastases by RFA-mediated Immunostimulation","official_title":"Improving Survival of COlorectal LIver Metastases by RFA-mediated Immunostimulation","primary_completion_date":"2023-02-01","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2024-08-01","last_update":"2021-03-15","description":"To examine radio frequency ablation as a treatment supplement to stimulate immunogenicity and improve survival for patients undergoing curative-intent surgery for colorectal liver metastases.","other_id":"ISCOLIM","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":99,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with metachronous colorectal liver metastases planned for resection\r\n\r\n          -  At least one tumor size >=3cm\r\n\r\n          -  Performance status 0-1\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Liver cirrhosis\r\n\r\n          -  Extrahepatic metastases\r\n\r\n          -  Other malignant diseases within 5 years prior to diagnosis\r\n      ","sponsor":"University of Aarhus","sponsor_type":"Other","conditions":"Liver Metastasis Colon Cancer","interventions":[{"intervention_type":"Device","name":"Device: RFA (radiofrequency ablation)","description":"Preoperative RFA-induced partial necrosis of the liver metastasis"}],"outcomes":[{"outcome_type":"primary","measure":"Overall survival","time_frame":"3 years","description":"Median survival in each arm"},{"outcome_type":"secondary","measure":"One-year survival","time_frame":"1 year","description":"One-year survival in each arm"},{"outcome_type":"secondary","measure":"Two-year survival","time_frame":"2 years","description":"Two-year survival in each arm"},{"outcome_type":"secondary","measure":"Three-year survival","time_frame":"3 years","description":"Three-year survival in each arm"},{"outcome_type":"secondary","measure":"Recurrence rate","time_frame":"1, 2, and 3 years","description":"Recurrence rate at 1, 2, and 3 years follow-up"},{"outcome_type":"other","measure":"Complications","time_frame":"30-day postoperatively","description":"Immediate postoperative complications (bleeding, surgical site infection, intraabdominal abscesses, bile leak)"}]}
{"nct_id":"NCT04948294","start_date":"2021-08-01","phase":"N/A","enrollment":140,"brief_title":"Comparison of the Intubation Condition Between Two Different Types of Video Laryngoscope Blades","official_title":"Comparison of the Intubation Condition Between Using Two Types of Blade in Patients Receiving Tracheal Intubation Using Videolaryngoscope: Channeled Blade vs. Non-channeled Blade","primary_completion_date":"2021-09-30","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2021-10-31","last_update":"2021-07-26","description":"The present study compares two different types of videolaryngoscope blade, which is a channeled and non-channeled blade. The purpose of the study is to investigate the effect of the type of videolaryngoscope blade on the intubation condition.","other_id":"KHNMC 2019-07-020-001","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"Double","intervention_model_description":"Patients requiring tracheal intubation for general anesthesia","sampling_method":"","gender":"All","minimum_age":19,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients receiving tracheal intubation for general anesthesia\r\n\r\n          -  Patients with physical status 1, 2, or 3 by American Society of Anesthesiologists\r\n             Physical Status.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Body mass index <18.5 kg/m2 or >35 kg/m2\r\n\r\n          -  Patients with a history of airway surgery\r\n\r\n          -  Patients with increased risk of aspiration\r\n\r\n          -  Patients who have any pathology (polyp, tumor, or inflammation) in the upper airway\r\n             and larynx\r\n      ","sponsor":"Kyung Hee University Hospital at Gangdong","sponsor_type":"Other","conditions":"Intubation Complication","interventions":[{"intervention_type":"Device","name":"Device: Channeled blade","description":"In the present group, a tracheal tube was launched in the channel of the blade before tracheal intubation"},{"intervention_type":"Device","name":"Device: Non-channeled blade","description":"In the present group, a tracheal tube was not launched in the videolaryngoscope blade before tracheal intubation"}],"outcomes":[{"outcome_type":"primary","measure":"Intubation time","time_frame":"Immediately after tracheal intubation completed","description":"the time for tracheal intubation"},{"outcome_type":"secondary","measure":"First-pass rate","time_frame":"Immediately after tracheal intubation completed","description":"the success rate of tracheal intubation with one attempt"},{"outcome_type":"secondary","measure":"Intubation-related complications","time_frame":"within 24 hours after surgery","description":"the incidence of overall complications related with tracheal intubation"}]}
{"nct_id":"NCT04473937","start_date":"2021-07-31","phase":"N/A","enrollment":20,"brief_title":"Radiation Post-CAR T in Refractory Lymphoma","official_title":"Radiation Therapy To Enhance CAR T Efficacy Early in Post-CAR T Cell Therapy Refractory Lymphoma: A Pilot Study","primary_completion_date":"2022-05-01","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2024-05-01","last_update":"2021-01-20","description":"This study is evaluating the safety and efficacy of using radiotherapy in participants who have refractory lymphoma shortly after receiving CAR T cell therapy (axicel or tisacel).","other_id":"19-861","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients must be able to undergo biopsy. Biopsy will be obtained for patients to\r\n             exclude possibility of false negative residual FDG avidity on PET/CT that is not\r\n             substantially increased relative to pre-CAR-T PET/CT. Exceptions are allowed for\r\n             patients who have clearly progressive disease for whom delaying radiation therapy to\r\n             obtain a biopsy may worsen outcome (such as cases of cord compression), and for\r\n             patients for whom the risks of biopsy are high (such as patients with evidence for CNS\r\n             involvement).\r\n\r\n          -  Biopsy-confirmed refractory disease within 30-90 days following commercial\r\n             axicabtagene ciloleucel or tisagenlecleucel therapy for a hematologic malignancy\r\n             (these include relapsed or refractory large B-cell lymphoma after two or more lines of\r\n             systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise\r\n             specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and\r\n             DLBCL arising from follicular lymphoma). Of note, 'refractory' refers to patients who\r\n             had early refractory disease after CAR-T cell therapy and not to patients who have\r\n             received CAR-T for refractory disease, but had complete response to CAR-T cell\r\n             therapy.\r\n\r\n          -  At least 1 measurable lesion according to the Lugano criteria1. Lesions that have been\r\n             previously irradiated will be considered measurable only if progression has been\r\n             documented following completion of radiation therapy\r\n\r\n          -  The following criteria pertain to pattern of progression:\r\n\r\n               -  Patients may have one refractory lesion without other residual or progressive\r\n                  disease as per PET/CT\r\n\r\n               -  Patients may have more than one refractory lesion, but with evidence for at least\r\n                  partial response of at least one other lesion as per PET/CT\r\n\r\n               -  Patients with more than one site of refractory disease without evidence for at\r\n                  least partial response of at least one other lesion are eligible if they are:\r\n\r\n                    -  A. Symptomatic from a refractory lesion (such as cord compression or focal\r\n                       pain) or\r\n\r\n                    -  B. Have disease that can locally affect the spinal canal or brain if left\r\n                       untreated.\r\n\r\n          -  Toxicities due to prior therapy must be stable and recovered to  Grade 1 (except for\r\n             clinically non-significant toxicities such as alopecia and prolonged cytopenias that\r\n             are not expected to worsen during RT) if there is concern for overlap of anticipated\r\n             radiation-related toxicity and toxicity from prior therapy due to where the RT field\r\n             is located.\r\n\r\n          -  Age 18 or older\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to\r\n             2.\r\n\r\n          -  Ability to understand and the willingness to sign a written informed consent document.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any medical condition likely to interfere with assessment of safety or efficacy of RT\r\n\r\n          -  Patients with more than one site of disease without any evidence for response to CAR T\r\n             cell therapy who are not focally symptomatic due to progressive disease or do not have\r\n             disease that can locally affect the spinal canal or brain if left untreated\r\n\r\n          -  Women of child-bearing potential who are pregnant because of the potentially dangerous\r\n             effects of the preparative chemotherapy on the fetus or infant. Females who have\r\n             undergone surgical sterilization or who have been postmenopausal for at least 2 years\r\n             are not considered to be of childbearing potential.\r\n\r\n          -  In the investigators judgment, the subject is unlikely to complete all\r\n             protocol-required study visits or procedures, including follow-up visits, or comply\r\n             with the study requirements for participation.\r\n      ","sponsor":"Massachusetts General Hospital","sponsor_type":"Other","conditions":"Hematologic Malignancy|Refractory Lymphoma","interventions":[{"intervention_type":"Radiation","name":"Radiation: Radiotherapy","description":"Radiotherapy at pre-determined dose and schedule"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0","time_frame":"30 days","description":"Rate and severity of RT-related toxicity as per CTCAE v5.0 criteria during RT or within the first 30 days of completing RT."},{"outcome_type":"secondary","measure":"Duration of response (DOR)","time_frame":"First objective response (which is subsequently confirmed) to disease progression per Lugano criteria or death regardless of cause or up to 2 years","description":"The competing-risk analysis method will be used to estimate the cumulative incidence of relapse. The cumulative incidence of relapse in the presence of non-disease related mortality (the competing risk) will be estimated along with 2-sided 95% confidence intervals at 3-month intervals.\r\nAmong subjects who experience an objective response, DOR is defined as the date of their first objective response (which is subsequently confirmed) to disease progression per Lugano criteria or death regardless of cause. Subjects not meeting the criteria for progression or death by the analysis data cutoff date will be censored at their last evaluable disease assessment date and their response will be noted as ongoing."},{"outcome_type":"secondary","measure":"Objective response rate (ORR) per IRRC","time_frame":"defined as the incidence of either a complete response or a partial response by Lugano criteria or up to 2 years","description":"ORR per IRRC is defined as the incidence of either a complete response or a partial response by Lugano criteria as determined by the IRRC. All subjects that do not meet the criteria for an objective response by the analysis data cutoff date will be considered non-responders."},{"outcome_type":"secondary","measure":"Progression-free Survival (PFS)","time_frame":"Time from RT completion date to the date of disease progression per Lugano criteria or death from any cause up to 2 years","description":"Kaplan-Meier estimates and 2-sided 95% confidence intervals will be generated for progression free survival time. Estimates of the proportion of subjects alive and progression-free at 3-month intervals will be provided.\r\nPFS is defined as the time from RT completion date to the date of disease progression per Lugano criteria or death from any cause. Subjects not meeting the criteria for progression by the analysis data cutoff date will be censored at their last evaluable disease assessment date."},{"outcome_type":"secondary","measure":"Overall All Survival","time_frame":"OS is defined as the time from RT completion to the date of death up to 2 years","description":"Kaplan-Meier estimates and 2-sided 95% confidence intervals will be generated for OS. Estimates of the proportion of subjects alive at 3-month intervals will be provided"}]}
{"nct_id":"NCT04946968","start_date":"2021-07-31","phase":"Phase 2","enrollment":104,"brief_title":"Phase-2 Dacomitinib Study on Patients With EGFR-Driven Advanced Solid Tumours With Low EGFR-AS1 IncRNA Expr or Other Novel Emerging Biomarkers","official_title":"A Phase II Multi-Centre Study Evaluating the Efficacy of Dacomitinib for Patients With Epidermal Growth Factor Receptor (EGFR)-Driven Advanced Solid Tumours With Low EGFR-AS1 IncRNA Expression or Other Novel Emerging Biomarkers","primary_completion_date":"2025-07-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2026-07-31","last_update":"2021-07-01","description":"Eligible subjects will be allocated to one of four cohorts based on tumour type and presence of specific biomarker. Subjects will receive open-label Dacomitinib as tablets for oral administration on a continuous daily basis at a dose of 30 mg for one cycle. After one cycle, a toxicity assessment will be conducted. Subjects with >=G2 toxicity attributable to dacomitinib, will continue dacomitinib at 30 mg orally once daily. In subjects with <=G1 toxicity, investigator and subjects will make a shared decision for dose escalation of dacomitinib to 45 mg orally once daily or continuation of dacomitinib at 30 mg orally once daily. Subjects will then continue on therapy until disease progression, new systemic anticancer therapy instituted, intolerable toxicities, withdrawal of consent, death, or investigator decision dictated by protocol compliance, whichever occurs first.","other_id":"STCC-01","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Eligible subjects will be allocated to one of four cohorts based on tumour type and presence of specific biomarker. All subjects in cohorts 1 to 3 will have tumours that demonstrate low EGFR-AS1 lncRNA expression as determined through a companion diagnostic biomarker suite (consisting of three components - EGFR Q787Q AA genotype, low AS1 lncRNA levels and increased EGFR isoform D/A ratio).\r\nCohort 1 will consist of squamous NSCLC patients with the presence of at least 1 out of 3 in the biomarker suite.\r\nCohort 2 will consist of HNSCC patients with the presence of at least 1 out of 3 in the biomarker suite.\r\nCohort 3 will consist of any other solid tumour with the presence of at least 1 out of 3 in the biomarker suite.\r\nCohort 4 will have tumours that demonstrate the presence of a novel emerging biomarker including but not limited to NRG1 fusions and specific MET SNPs.","sampling_method":"","gender":"All","minimum_age":21,"maximum_age":99,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Provision of a voluntarily given, personally signed and dated, written informed\r\n             consent document. If consent cannot be expressed in writing, it must be formally\r\n             documented and witnessed, ideally via an independent trusted witness;\r\n\r\n          -  Age  21 years, male or female;\r\n\r\n          -  Documentation of the presence of low EGFR-AS1 lncRNA expression as determined using\r\n             the specifically designed companion diagnostic biomarker suite provided by the Sponsor\r\n             (cohorts 1 to 3) or the presence of a novel emerging biomarker of EGFR family pathway\r\n             addiction as determined by the Sponsor (cohort 4);\r\n\r\n          -  Study cohorts:\r\n\r\n               -  Cohort 1: advanced or metastatic EGFR wildtype squamous NSCLC, after progression\r\n                  on or after, or intolerance to, one or more lines of standard of care (SOC)\r\n                  therapy, per local SOC guidelines. In subjects without an activating oncogenic\r\n                  driver mutation, after progression on or after, or intolerance to,\r\n                  platinum-containing combination chemotherapy. In subjects harbouring an\r\n                  activating oncogenic driver mutation, after progression on one or more SOC\r\n                  mutation-targeting TKI, per local SOC guidelines, or for whom no SOC\r\n                  mutation-targeting TKI is available. TKI therapy need not be the most recent\r\n                  prior therapy. Subjects harbouring an activating EGFR mutation are not eligible;\r\n\r\n               -  Cohort 2: advanced or metastatic head and neck squamous cell carcinoma, after\r\n                  progression on or after, or intolerance to, platinum-containing combination\r\n                  chemotherapy. This need not be the most recent or prior regimen;\r\n\r\n               -  Cohort 3: all advanced or metastatic solid tumours (excluding squamous NSCLC and\r\n                  HNSCC), after progression on or intolerance to at least one line of SOC therapy\r\n                  per local guidelines;\r\n\r\n               -  Cohort 4: all advanced or metastatic solid tumours, after progression on or\r\n                  intolerance to at least one line of SOC therapy per local guidelines;\r\n\r\n          -  Have an ECOG PS of 2;\r\n\r\n          -  Life expectancy of at least 3 months;\r\n\r\n          -  Site of disease amenable to biopsy and be a candidate for tumour biopsy according to\r\n             the treating institution's own guidelines and requirements for such procedure.\r\n             Subjects must be willing to undergo a tumour biopsy at screening, and on treatment on\r\n             this study;\r\n\r\n          -  Radiologically measurable disease by RECIST v1.1 criteria:\r\n\r\n               -  At least one target lesion that has not previously been radiated and is\r\n                  measurable according to RECIST v1.1;\r\n\r\n               -  Acceptable radiologic procedures for disease assessment include contrast enhanced\r\n                  conventional or spiral computed tomography (CT), or contrast enhanced magnetic\r\n                  resonance imaging (MRI);Non contrast CT scan is acceptable only for subjects who\r\n                  are both allergic to intravenous contrast and unable to cooperate with MRI, or\r\n                  MRI is not available. The following are not allowed as sole documentation of\r\n                  target lesions: CT component of a positron emission tomography (PET)/CT,\r\n                  ultrasound alone, nuclear scans (including bone or PET scans), chest X-ray or\r\n                  bone radiographs, and tumour markers;\r\n\r\n          -  Adequate organ function, including:\r\n\r\n               -  Estimated creatinine clearance 30 mL/min (as determined by Cockcroft-Gault\r\n                  formula or the study site's standard formula);\r\n\r\n               -  Absolute neutrophil count (ANC) 1500 cells/mm3;\r\n\r\n               -  Platelets 100,000 cells/mm3;\r\n\r\n               -  Hemoglobin 10.0 g/dL;\r\n\r\n               -  Bilirubin 1.5 x upper limit of normal (ULN);\r\n\r\n               -  Aspartate aminotransferase (AST; also known as SGOT) and Alanine aminotransferase\r\n                  (ALT; also known as SGPT) 2.5 x ULN (5.0 x ULN if hepatic metastases).\r\n\r\n          -  Female subjects must be postmenopausal (defined as 12 months of amenorrhea following\r\n             last menses), or they or their partners must be surgically sterile, or must agree to\r\n             use effective contraception while receiving study treatment and for at least 3 months\r\n             thereafter. The definition of effective contraception will be based on the judgment of\r\n             the investigator using following criteria:\r\n\r\n               -  Acceptable contraception for women include implants, injectables, combined oral\r\n                  contraceptives, intrauterine devices (IUDs), sexual abstinence, or a partner who\r\n                  has been surgically sterile (e.g. by vasectomy) for at least 6 months. Acceptable\r\n                  contraception for a male includes surgical sterility (e.g. by vasectomy) for at\r\n                  least 6 months, sexual abstinence, or condoms plus spermicide.\r\n\r\n          -  All female subjects with reproductive potential must have a negative pregnancy test\r\n             (serum or urine) before starting study treatment;\r\n\r\n          -  Male subjects or their female partners must be surgically sterile or must agree to use\r\n             effective contraception while receiving study treatment and for at least 3 months\r\n             thereafter. The definition of effective contraception will be based on the judgment of\r\n             the investigator. Or female partners must be postmenopausal (defined as 12 months of\r\n             amenorrhea following last menses);\r\n\r\n          -  Willing and able to comply with study scheduled visits, treatment plans, laboratory\r\n             tests, and other study procedures.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subjects with symptomatic brain metastases or leptomeningeal metastases who are\r\n             neurologically unstable or require increasing doses of steroids to manage central\r\n             nervous system (CNS) symptoms within two weeks prior to starting dacomitinib;\r\n\r\n          -  Any surgery (not including minor procedures such as lymph node biopsy), palliative\r\n             radiotherapy or pleurodesis within 2 weeks of baseline assessments;\r\n\r\n          -  Any clinically significant gastrointestinal abnormalities that may impair intake,\r\n             transit or absorption of the study drug, such as the inability to take oral\r\n             medication;\r\n\r\n          -  Current enrollment in another therapeutic clinical study;\r\n\r\n          -  Any psychiatric or cognitive disorder that would limit the understanding or rendering\r\n             of informed consent and/or compromise compliance with the requirements of this study\r\n             or known drug abuse/alcohol abuse;\r\n\r\n          -  History of, or currently suspected, diffuse non-infectious pneumonitis or interstitial\r\n             lung disease including:\r\n\r\n               -  Past medical history of interstitial lung disease, drug-induced interstitial\r\n                  disease, radiation pneumonitis which required steroid treatment or any evidence\r\n                  of clinically active interstitial lung disease;\r\n\r\n               -  Pre-existing idiopathic pulmonary fibrosis evidenced by CT scan at baseline;\r\n\r\n               -  Insufficient lung function as determined by either clinical examination or an\r\n                  arterial oxygen tension of <70 Torr.\r\n\r\n          -  Any history of galactose intolerance, Lapp lactase deficiency or glucose-galactose\r\n             malabsorption;\r\n\r\n          -  Clinically important abnormalities in cardiac rhythm, conduction or morphology of\r\n             resting ECG (e.g. complete left bundle branch block, second degree heart block, third\r\n             degree heart block) OR:\r\n\r\n               -  Diagnosed or suspected congenital long QT syndrome;\r\n\r\n               -  Any history of clinically significant ventricular arrhythmias (such as\r\n                  ventricular tachycardia, ventricular fibrillation, or Torsades de pointes);\r\n\r\n               -  Prolonged QTc interval on electrocardiogram (ECG); QTc must be less than\r\n                  CTCAEv5.0 Grade 2 (480 msec) using Fridericia's or Bazett's correction formula\r\n                  with a manual reading by the investigator if required. The ECG may be repeated\r\n                  for evaluation of eligibility after management of correctable causes for observed\r\n                  QTc prolongation;\r\n\r\n               -  Any history of second- or third-degree heart block;\r\n\r\n               -  Heart rate <45 beats per minute on ECG in the presence of clinical symptoms\r\n                  (e.g., hypotension, evidence of hypoperfusion);\r\n\r\n          -  Severely impaired (defined as Child-Pugh Class C) hepatic dysfunction;\r\n\r\n          -  Prior malignancy: Subjects will not be eligible if they have history of, or evidence\r\n             of another concurrent malignancy within 2 years prior to registration. Exception would\r\n             be effectively treated past history of non-melanoma skin cancer or in-situ cervical\r\n             cancer with no evidence of active disease. Patients with a history of other\r\n             malignancies are eligible if they have been continuously disease free for at least 2\r\n             years after definitive primary treatment;\r\n\r\n          -  Other severe acute or chronic medical condition that may increase the risk associated\r\n             with study participation or study drug administration or may interfere with the\r\n             interpretation of study results and, in the judgment of the investigator, would make\r\n             the subject inappropriate for entry into this study;\r\n\r\n          -  Use of narrow therapeutic index drugs that are CYP2D6 substrates (procainamide,\r\n             pimozide, and thioridazine etc.) from screening to randomization.\r\n      ","sponsor":"National Cancer Centre, Singapore","sponsor_type":"Other","conditions":"Advanced Solid Tumours|Non-small Cell Lung Cancer|Head and Neck Squamous Cell Carcinoma","interventions":[{"intervention_type":"Drug","name":"Drug: Oral Dacomitinib","description":"All subjects will receive the open-label Dacomitinib as tablets for oral self-administration on a continuous daily basis at a dose of 30 mg for one cycle. For subjects eligible for dose titration after Cycle 1, and after shared patient and investigator decision, these subjects will receive Dacomitinib 45 mg orally on a continuous daily basis."}],"outcomes":[{"outcome_type":"primary","measure":"Objective Response Rate","time_frame":"From time of first study drug administration until first occurrence of disease progression, up to 36 months.","description":"The proportion of subjects with a BOR of either CR or PR, where BOR is the best response recorded from the start of treatment until disease progression."},{"outcome_type":"secondary","measure":"Progression Free Survival","time_frame":"The time from start of treatment to the date of disease progression as defined by RECIST v1.1 per investigator review or death due to any cause, whichever occurs first, up to 36 months.","description":"The time from start of treatment to the date of disease progression or death due to any cause, whichever occurs first."},{"outcome_type":"secondary","measure":"Duration of Response","time_frame":"The time from the initial response to therapy to the date of subsequent disease progression as defined by RECIST v1.1 per investigator review or date of death (if cause of death is due to PD), whichever earlier, up to 36 months.","description":"The time from the initial response to therapy to the date of subsequent disease progression or date of death (if cause of death is due to PD), whichever earlier."},{"outcome_type":"secondary","measure":"Overall Survival","time_frame":"The time from start of treatment to the date of death for any cause, up to 36 months.","description":"The time from start of treatment to the date of death for any cause."}]}
{"nct_id":"NCT04233606","start_date":"2021-07-31","phase":"N/A","enrollment":16,"brief_title":"Influence of Osmotic Stimulation of Vasopressin on Autonomic Function","official_title":"Influence of Osmotic Stimulation of Vasopressin on Autonomic Function","primary_completion_date":"2022-02-28","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2022-05-31","last_update":"2020-11-04","description":"The regulation of total body water that defines human hydration status is a complex and dynamic process. Current methods of assessing hydration status (e.g. hematologic and urinary analyses) lack the ability to track changes in hydration status in real-time due to whole-body homeostatic physiologic processes required to maintain central pressure and cardiovascular function. This project will address this problem by assessing the relationship between autonomic function (measured using heart rate variability), a brain-derived process that regulates cardiovascular function, and changes in the hydration-mediated hormone vasopressin.","other_id":"20-0206","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","intervention_model_description":"Participants will complete two trials under two different hydration states: isovolemic increase in plasma osmolality and isovolemic control (maintain normal plasma osmolality)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":35,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Males and Females between the ages of 18 - 35\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  1) evidence of clinically relevant diseases that may alter body water regulation\r\n             (e.g., diabetes, kidney disease, metabolic disorders, cardiovascular disease, and\r\n             other potential fluid balance covariates such as habitual use of non-steroidal\r\n             anti-inflammatory drugs or serotonin reuptake inhibitors,\r\n\r\n             2) previous surgery on the digestive tract that may impair the body's ability to\r\n             normally regulate body water,\r\n\r\n             3) regular drug treatment within the previous 15 days,\r\n\r\n             4) actively attempting to gain or lose body weight,\r\n\r\n             5) For female participants, testing will take place during the early follicular phase\r\n             of their menstrual cycle (days 1-8) to maintain consistency in the hydration status\r\n             measures as total body water fluctuates over the course of the menstrual cycle.\r\n             Females who are currently using contraceptives (e.g., IUD) that limit the number of\r\n             menstrual cycles occurring in a given year will be excluded from this study to ensure\r\n             accuracy in the testing periods for this study.\r\n      ","sponsor":"University of North Carolina, Greensboro","sponsor_type":"Other","conditions":"Water Stress|Body Water Dehydration","interventions":[{"intervention_type":"Other","name":"Other: Hypertonic Saline","description":"Infusion of hypertonic saline to induce an osmotic secretion of the hormone vasopressin"},{"intervention_type":"Other","name":"Other: Normal Saline","description":"Infusion of normal saline to inhibit the secretion of the hormone vasopressin"}],"outcomes":[{"outcome_type":"primary","measure":"Change in autonomic function","time_frame":"0, 15, 30, 45, 60, 75, 90, 105, 120 minutes of saline infusion period","description":"Changes in parasympathetic and sympathetic tone as measured by heart rate variability"}]}
{"nct_id":"NCT04975711","start_date":"2021-07-31","phase":"Phase 1","enrollment":48,"brief_title":"Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP2105 to RLD2104 in Healthy Volunteers","official_title":"A Randomized, Open-label, Multiple Dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP2105 to RLD2104 in Healthy Volunteers","primary_completion_date":"2021-11-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-11-30","last_update":"2021-07-23","description":"A Phase 1 Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP2105 to RLD2104 in Healthy Volunteers","other_id":"HM-ESOB-102","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":19,"maximum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy volunteers in the age between 19 and 50 years old.\r\n\r\n          -  Body mass index (BMI) in the range of 19 to 28 kg/m2 and weight 55.0kg to 90.0kg.\r\n\r\n          -  After fully hearing and understanding the details of this clinical trial, Subjects who\r\n             have willingness to sign of informed consent before the screening.\r\n\r\n          -  Subject who are eligible from physical examination, clinical laboratory test by\r\n             investigators judgment.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Gastrointestinal disorders (gastrointestinal ulcers, gastritis, stomach cramps,\r\n             gastro-esophageal reflux disease, Crohn's disease or chronic pancreatitis) or\r\n             gastrointestinal surgery (except for simple cecal or hernia surgery) which may affect\r\n             the safety and pharmacokinetic evaluation of test drug.\r\n\r\n          -  Subjects who have a history of hypersensitivity or clinically significant\r\n             hypersensitivity to investigational product or the same component or other drugs\r\n             (aspirin, antibiotics, etc.).\r\n\r\n          -  Aspartate aminotransferase and alanine aminotransferase exceed 1.5 times the upper\r\n             limit of normal range from screening laboratory results before randomization.\r\n\r\n          -  Subject who continues to drink (21 units / week, 1 unit = 10 g of pure alcohol) within\r\n             a month before the screening visit or who cannot abstain during the hospital stay.\r\n\r\n          -  Heavy smoker (>10 cigarettes/day).\r\n      ","sponsor":"Hanmi Pharmaceutical Company Limited","sponsor_type":"Industry","conditions":"Healthy Volunteer","interventions":[{"intervention_type":"Drug","name":"Drug: HIP2105","description":"Test drug"},{"intervention_type":"Drug","name":"Drug: RLD2104","description":"Reference drug"}],"outcomes":[{"outcome_type":"primary","measure":"AUCtau","time_frame":"0-24hours"},{"outcome_type":"primary","measure":"Reduced rate from baseline in 24h integrated gastric pH","time_frame":"0-24hours"},{"outcome_type":"secondary","measure":"Cmax","time_frame":"0-24hours"},{"outcome_type":"secondary","measure":"Tmax","time_frame":"0-24hours"},{"outcome_type":"secondary","measure":"t1/2","time_frame":"0-24hours"},{"outcome_type":"secondary","measure":"CL/F","time_frame":"0-24hours"},{"outcome_type":"secondary","measure":"Vd/F","time_frame":"0-24hours"},{"outcome_type":"secondary","measure":"AUClast","time_frame":"0-24hours"},{"outcome_type":"secondary","measure":"Cmin,ss","time_frame":"0-24hours"},{"outcome_type":"secondary","measure":"Cmax,ss","time_frame":"0-24hours"},{"outcome_type":"secondary","measure":"t1/2,ss","time_frame":"0-24hours"},{"outcome_type":"secondary","measure":"CLss/F","time_frame":"0-24hours"},{"outcome_type":"secondary","measure":"Vd,ss/F","time_frame":"0-24hours"},{"outcome_type":"secondary","measure":"Reduced rate from baseline in 24h integrated gastric pH","time_frame":"0-24hours"},{"outcome_type":"secondary","measure":"Duration time with integrated gastric pH>4 / 24hr","time_frame":"0-24hours"},{"outcome_type":"secondary","measure":"Median 24 hr gastric pH","time_frame":"0-24hours"}]}
{"nct_id":"NCT04932057","start_date":"2021-07-31","phase":"N/A","enrollment":60,"brief_title":"The Investigation of Acute Effects of Action Observation Training on Upper Extremity Functionality, Reaction Time and Cognitive Functions in Right-handed Healthy Subjects","official_title":"The Investigation of Acute Effects of Action Observation Training on Upper Extremity Functionality, Reaction Time and Cognitive Functions in Right-handed Healthy Subjects","primary_completion_date":"2021-08-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2021-09-30","last_update":"2021-07-22","description":"The aim of the study is to investigate the acute effects of action observation training on upper extremity functionality, reaction times, and cognitive functions in right-handed healthy subjects.","other_id":"Izmir Katip Celebi University","allocation":"Randomized","intervention_model":"Sequential Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":30,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  >18 years old\r\n\r\n          -  willingness\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  any kind of neurological or musculoskeletal problems\r\n\r\n          -  sight problems\r\n\r\n          -  pain in the upper limb\r\n\r\n          -  left handedness\r\n      ","sponsor":"Dokuz Eylul University","sponsor_type":"Other","conditions":"Right-handed Healthy Adults","interventions":[{"intervention_type":"Other","name":"Other: Action observation Training","description":"Action observation training is a relatively new rehabilitation approach in which the subject is asked to carefully observe the actions presented through a video clip or performed by an operator."},{"intervention_type":"Other","name":"Other: Action Practice","description":"Participants perform an upper extremity functionality test a couple of times."},{"intervention_type":"Other","name":"Other: Observation","description":"Participants will watch a slide show of landscape"}],"outcomes":[{"outcome_type":"primary","measure":"Change in upper extremity functionality","time_frame":"The outcome will be assessed at baseline and immediately after the intervention.","description":"Jebsen-Taylor Hand Function Test will be used"},{"outcome_type":"primary","measure":"Change in upper extremity dexterity","time_frame":"The outcome will be assessed at baseline and immediately after the intervention.","description":"Nine-Hole Peg Test will be used."},{"outcome_type":"primary","measure":"Change in cognitive functions","time_frame":"The outcome will be assessed at baseline and immediately after the intervention.","description":"Serial Reaction Time Task will be used."},{"outcome_type":"primary","measure":"Change in cognitive functions","time_frame":"The outcome will be assessed at baseline and immediately after the intervention.","description":"d2 Test of Attention will be used."},{"outcome_type":"primary","measure":"Change in reaction time","time_frame":"The outcome will be assessed at baseline and immediately after the intervention.","description":"Ruler drop test will be used."}]}
{"nct_id":"NCT04882878","start_date":"2021-07-30","phase":"Phase 2","enrollment":225,"brief_title":"A Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus","official_title":"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus","primary_completion_date":"2023-07-06","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2024-05-28","last_update":"2021-08-04","description":"The purpose of this study is to evaluate the efficacy of nipocalimab versus placebo in participants with active systemic lupus erythematosus (SLE).","other_id":"CR109011","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Has a clinical diagnosis of systemic lupus erythematosus (SLE) greater than or equal\r\n             to (>=) 6 months prior to the screening visit and according to Systemic Lupus\r\n             International Collaborating Clinics (SLICC)-2012 classification criteria: at least 4\r\n             criteria fulfilled, with at least 1 clinical criterion and 1 immunologic criterion\r\n\r\n          -  Has at least 1 BILAG (british isles lupus assessment group) A and/or 2 BILAG B scores\r\n             observed during screening\r\n\r\n          -  Must have at least moderately active SLE, as defined as systemic lupus erythematosus\r\n             disease activity index 2000 (SLEDAI-2K) score >= 6 at screening visit. Must also have\r\n             SLEDAI 2K >= 4 for clinical features (that is, SLEDAI-2K score excluding headache and\r\n             laboratory abnormalities) present at Week 0 prior to randomization\r\n\r\n          -  Has a CLASI (cutaneous lupus erythematosus disease area and severity index) activity\r\n             score of at least 6 (excluding diffuse non-inflammatory alopecia) or at least 4 joints\r\n             with pain and signs of inflammation (active joints) at screening or at Week 0, or both\r\n\r\n          -  At least 1 unequivocally positive autoantibody test including antinuclear antibodies\r\n             (ANA) (>= 1:80) and/or anti-double stranded deoxyribonucleic acid (dsDNA) antibodies\r\n             (level >= 75 international units/milliliter [IU/mL]) and/or anti-Smith antibodies\r\n             (>120 Absorbance unit/milliliter [AU/mL]) detected during screening\r\n\r\n          -  Must be receiving 1 or more of the following protocol-permitted, systemic\r\n             standard-of-care treatments prior to first administration of study intervention at a\r\n             stable dose: oral glucocorticoids, antimalarial or up to 2 immunomodulatory drugs\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Current or history of, severe, progressive, or uncontrolled renal disease, with the\r\n             exception of active lupus nephritis (LN). Have severe active LN as determined by\r\n             sponsor (or designee) adjudication\r\n\r\n          -  Has any unstable or progressive manifestation of SLE that is likely to warrant\r\n             escalation in therapy beyond permitted background medications\r\n\r\n          -  Has other inflammatory diseases that might confound the evaluations of efficacy\r\n\r\n          -  Has a severe infection including opportunistic infections requiring parenteral\r\n             anti-infectives, and/or hospitalization within 8 weeks prior to screening\r\n\r\n          -  Has received a single B-cell targeting agent within 3 months prior to first\r\n             administration of study intervention\r\n      ","sponsor":"Janssen Research & Development, LLC","sponsor_type":"Industry","conditions":"Systemic Lupus Erythematosus","interventions":[{"intervention_type":"Other","name":"Other: Placebo","description":"Placebo will be administered intravenously."},{"intervention_type":"Drug","name":"Drug: Nipocalimab","description":"Nipocalimab dose 1 and dose 2 will be administered intravenously."},{"intervention_type":"Drug","name":"Drug: Standard-of-care treatment","description":"Standard-of-care treatment including immunomodulators, antimalarial drugs and GCs will be administered orally."}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of Participants Achieving an Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4 Composite Response at Week 24","time_frame":"Week 24","description":"SLE SRI-4 composite response is a composite of at least 4-point improvement in SLE Disease Activity Index 2000(SLEDAI-2K), no worsening in British Isles Lupus Assessment Group (BILAG), no worsening in Physician's Global Assessment of Disease Activity score (PGA) and not meeting study treatment failure criteria."},{"outcome_type":"secondary","measure":"Percentage of Participants with Baseline Active Mucocutaneous Lupus Manifestations (Cutaneous Lupus Erythematosus Disease Area and Severity Index [CLASI] Activity Score >= 6) Achieving >= 50 Percent (%) Reduction in the CLASI Activity Score at Week 24","time_frame":"Week 24","description":"Percentage of participants achieving at least 50% improvement in CLASI Activity Score at Week 24 will be reported in participants with a CLASI Activity Score of 6 or greater at baseline. Cutaneous lupus disease activity and severity will be measured by the CLASI. The CLASI is an instrument to assess the disease activity and damage caused to the skin for cutaneous lupus erythematosus participants with or without systemic involvement. The CLASI consists of 2 scores; the first summarizes the activity of the disease while the second is a measure of the damage caused by the disease."},{"outcome_type":"secondary","measure":"Percentage of Participants with Baseline Arthritis (with at Least 4 Active Joints at Baseline) Achieving >= 50% Reduction in Active Joints at Week 24","time_frame":"Week 24","description":"Percentage of participants with baseline arthritis (with at least 4 active joints at baseline) achieving >= 50% reduction in active joints at Week 24 will be reported."},{"outcome_type":"secondary","measure":"Percentage of Participants with >= 4 Point Improvement in SLE Disease Activity Index 2000 (SLEDAI-2K) at Week 24","time_frame":"Week 24","description":"Percentage of participants achieving at least 4 point improvement in SLEDAI-2K will be reported. The SLEDAI-2K is an established, validated SLE activity index. It is based on the presence of 24 features in 9 organ systems and measures disease activity in SLE participants at the time of the visit or in the previous 30 days; the index is weighted according to the feature. Features are scored by the assessing physician if present at the time of the visit or within the last 30 days, with more severe features having higher scores, and then simply added to determine the total SLEDAI-2K score, which ranges from 0 to 105, with higher scores representing increased disease activity."},{"outcome_type":"secondary","measure":"Percentage of Participants Achieving the British Isles Lupus Assessment Group (BILAG) Composite Lupus Assessment (BICLA) Response at Week 24","time_frame":"Week 24","description":"Percentage of participants achieving BICLA Response (BILAG-2004 disease activity improvement without worsening, and without worsening of SLEDAI-2K or PGA compared to baseline) at Week 24 will be reported."},{"outcome_type":"secondary","measure":"Time to First Flare Through Week 24","time_frame":"Up to Week 24","description":"Time to first flare through Week 24, with flare defined as either 1 or more new BILAG A or 2 or more new BILAG B scores will be reported."},{"outcome_type":"secondary","measure":"Percentage of Participants Achieving SRI-4 Composite Response at Week 52","time_frame":"Week 52","description":"Percentage of participants achieving SRI-4 composite response at Week 52 will be reported."},{"outcome_type":"secondary","measure":"Percentage of Participants Receiving >= 10 milligram/day (mg/day) Prednisone or Equivalent at Baseline who Achieve Week 6-16 Glucocorticoid (GC) Taper Goal (at Week 16 to <= 7.5 mg/day Prednisone or Equivalent) and Maintain that Reduction Until Week 24","time_frame":"Up to Week 24","description":"Percentage of participants receiving >= 10 mg/day prednisone or equivalent at baseline who achieve Week 6-16 GC taper goal (at Week 16 to <= 7.5 mg/day prednisone or equivalent) and maintain that reduction until Week 24 will be reported."},{"outcome_type":"secondary","measure":"Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) Through Week 58","time_frame":"Up to Week 58","description":"An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment."},{"outcome_type":"secondary","measure":"Percentage of Participants with Treatment-emergent Serious Adverse Events (SAEs) Through Week 58","time_frame":"Up to Week 58","description":"SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. Treatment-emergent SAEs are defined as SAEs with onset or worsening on or after date of first dose of study treatment."},{"outcome_type":"secondary","measure":"Percentage of Participants with Treatment-emergent Adverse Events of Special interests (AESIs) Through Week 58","time_frame":"Up to Week 58","description":"Percentage of participants with treatment-emergent AESIs will be reported. Treatment-emergent adverse events associated with the following situations are considered as AESIs: infections that are severe or require intravenous anti-infective or operative/invasive intervention, hypoalbuminemia with albumin less than (<) 20 gram/liter (g/L) (<2.0 gram/deciliter [g/dL])."},{"outcome_type":"secondary","measure":"Percentage of Participants with Treatment-emergent AEs leading to treatment discontinuation Through Week 58","time_frame":"Up to Week 58","description":"Percentage of participants with treatment-emergent AEs leading to discontinuation of study intervention will be reported."},{"outcome_type":"secondary","measure":"Number of Participants with Change from Baseline in Laboratory Parameters Over Time","time_frame":"Up to Week 58","description":"Number of participants with change from baseline in laboratory parameters (hematology, chemistry, urinalysis and lipid profile) over time will be reported."},{"outcome_type":"secondary","measure":"Number of Participants with Change from Baseline in Vital Signs Parameters Over Time","time_frame":"Up to Week 58","description":"Number of participants with change from baseline in vital sign parameters (temperature, pulse/heart rate, respiratory rate, and blood pressure) will be reported."},{"outcome_type":"secondary","measure":"Serum Concentration of Nipocalimab Over Time","time_frame":"Up to Week 58","description":"Serum concentrations of nipocalimab over time in participants receiving active study intervention will be reported."},{"outcome_type":"secondary","measure":"Number of Participants with Antibodies to Nipocalimab (Anti-Drug Antibodies [ADAs] and Neutralizing Antibodies [Nabs])","time_frame":"Up to Week 58","description":"Number of participants with antibodies to nipocalimab (ADAs and Nabs) in participants receiving active study intervention will be reported."}]}
{"nct_id":"NCT04996108","start_date":"2021-07-29","enrollment":119,"brief_title":"Pericarditis: Auto-Inflammation in Recurrent Disease","official_title":"An Observational Study to Investigate the Auto-inflammatory Basis of Recurrent Pericarditis","primary_completion_date":"2024-06-13","study_type":"Observational","rec_status":"Recruiting","completion_date":"2024-06-13","last_update":"2021-08-17","description":"Pericarditis is swelling of the sac that surrounds the heart, the pericardium, causing chest pain. For most patients, the condition improves with simple anti-inflammatory medications like colchicine and ibuprofen. However, in 20-30% of patients the condition comes back. Diagnosis of recurrent pericarditis is frequently missed or delayed, and many patients require prolonged courses of corticosteroids to control their disease. Together these factors damage the quality of life of patients with recurrent pericarditis. Currently there is limited understanding of why pericarditis comes back in some patients, and how best to treat it when it does. PAIReD (Pericarditis: Auto-Inflammation in Recurrent Disease) is an observational research study funded by the British Heart Foundation that will investigate the role inflammation plays in recurrent pericarditis. Patients with recurrent pericarditis and other auto-inflammatory diseases will be recruited from the specialist fever clinic at the Royal Free Hospital, where they will be asked to donate blood up to six times over a three year period. Healthy participants will be recruited at the Royal Free Hospital or Guy's Hospital. Relatives of participants with recurrent pericarditis will be recruited at the Royal Free Hospital. They latter two groups will attend one appointment where blood or saliva samples will be taken. A subset of participants will also provide fingerstick blood samples and questionnaires from home, for up to one year. Clinical data will be collected prospectively and by retrospective case note review. Blood from participants will be analysed to look at how the immune cells of patients with recurrent pericarditis function during the course of their disease, and to look for genetic changes in patients with recurrent pericarditis that might contribute to their condition. Together this knowledge has to potential to help clinicians diagnose and monitor patients with recurrent pericarditis more accurately, and researchers to design more effective treatments.","other_id":"286959","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":16,"population":"Study population for cases comprises patients under the care of the recruiting sites with a\r\n        diagnosis of RP.","criteria":"\n        Inclusion Criteria:\r\n\r\n        Recurrent pericarditis (RP) cases:\r\n\r\n          1. Patients with RP, diagnosed by a clinician, meeting the European Society of Cardiology\r\n             (ESC) diagnostic criteria.\r\n\r\n          2. Where the aetiology of the RP is defined as idiopathic (i.e. there is no other\r\n             aetiology identified, such as infective, malignant, post cardiac injury, as part of an\r\n             autoimmune condition, as part of another known auto-inflammatory disease).\r\n\r\n        Relatives of RP cases:\r\n\r\n        First degree relatives of participants meeting the criteria for, and included in the study\r\n        as, RP cases.\r\n\r\n        Disease Controls:\r\n\r\n        Patients with a systemic auto-inflammatory disease, diagnosed by a trained specialist.\r\n\r\n        Healthy Controls:\r\n\r\n        Sex, ethnicity and aged matched healthy individuals who do not have a personal history of\r\n        pericarditis or systemic auto-inflammatory disease.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Individuals under 12 years of age\r\n\r\n          2. Adults who are unable to give written informed consent\r\n\r\n          3. Individuals who have received a blood transfusion within 4 weeks\r\n      ","sponsor":"King's College London","sponsor_type":"Other","conditions":"Idiopathic Recurrent Pericarditis","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Immune cell phenotype","time_frame":"Three years","description":"Exploratory analysis of the proportion, maturity and activation state of different immune cell populations in the peripheral blood, comparing cases and controls and correlated to disease activity in cases"},{"outcome_type":"primary","measure":"Immune cell gene expression","time_frame":"Three years","description":"Exploratory analysis of the transcriptome in immune cells in cases compared to controls, and correlated to disease activity in cases."},{"outcome_type":"secondary","measure":"Genotype","time_frame":"Three years","description":"Candidate gene analysis and whole exome sequencing of cases and familial controls."},{"outcome_type":"secondary","measure":"Clinical phenotype","time_frame":"Three years","description":"Characterisation of clinical course of cohort of RP patients, gathering data on disease activity and quality of life prospectively over three years"}]}
{"nct_id":"NCT04905277","start_date":"2021-07-27","phase":"Phase 3","enrollment":420,"brief_title":"Atenolol for the Prevention of Osteoporosis (APO)","official_title":"Beta1-Selective Blockade for Prevention of Postmenopausal Bone Loss: A Phase 3, Multi-Center, Double-Blinded, Randomized Placebo-Controlled Trial","primary_completion_date":"2024-06-21","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2025-01-20","last_update":"2021-07-29","description":"Evaluate whether treatment with a widely used beta blocker, atenolol, will prevent bone loss at the lower back and hip in postmenopausal women.","other_id":"18-005725","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","intervention_model_description":"Atenolol vs. Placebo","sampling_method":"","gender":"Female","minimum_age":50,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Able and willing to provide informed consent\r\n\r\n          -  Postmenopausal women (FSH  16 IU/L) (no menses for at least one year)\r\n\r\n          -  Aged 50-75 years\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Clinical diagnosis of diabetes mellitus requiring insulin\r\n\r\n          -  Clinically significant abnormality in any of the additional screening laboratory\r\n             studies\r\n\r\n          -  A1c- 8\r\n\r\n          -  Calcium - > upper limit lab value per site\r\n\r\n          -  AST- 2x upper normal limit\r\n\r\n          -  FSH- < 16IU/L\r\n\r\n          -  eGFR- < 45 mL/min/1.73m2 based on creatinine\r\n\r\n          -  CBC- Per PI interpretation of each patient\r\n\r\n          -  Presence of (documented clinical diagnosis of any of the following):\r\n\r\n               -  Significant liver or renal disease\r\n\r\n               -  Malignancy (including myeloma or clinical diagnosis of MGUS)\r\n\r\n               -  Malabsorption (as defined by clinical diagnosis)\r\n\r\n               -  Hypoparathyroidism (as defined by clinical diagnosis)\r\n\r\n               -  Hyperparathyroidism (as defined by clinical diagnosis)\r\n\r\n               -  Acromegaly\r\n\r\n               -  Cushing syndrome\r\n\r\n               -  Hypopituitarism\r\n\r\n               -  Severe chronic obstructive pulmonary disease\r\n\r\n               -  Pheochromocytoma\r\n\r\n               -  History of cardiac failure\r\n\r\n               -  Ejection Fraction <35%\r\n\r\n               -  PR interval > 200 msec on screening ECG or known heart block\r\n\r\n               -  History of bronchospastic disease\r\n\r\n               -  Gastric Bypass\r\n\r\n               -  Parkinson's\r\n\r\n               -  Rheumatoid Arthritis\r\n\r\n               -  Psoriatic Arthritis\r\n\r\n               -  Connective Tissue disease\r\n\r\n          -  Undergoing treatment with any medications that affect bone turnover, including the\r\n             following:\r\n\r\n               -  adrenocorticosteroids (oral for > 3 months within the past year or sustained\r\n                  inhaled corticosteroid use)\r\n\r\n               -  anticonvulsant therapy for seizures (carbamazepine, phenobarbital, or phenytoin\r\n                  within the previous year) pharmacological doses of: thyroid hormone (causing\r\n                  decline of thyroid stimulating hormone below normal, i.e. < 0.3 miU/L)\r\n                  bisphosphonates (within the past 3 yrs) denosumab, romosozumab, estrogen therapy\r\n                  or treatment with a selective estrogen receptor modulator, or\r\n                  teriparatide/abaloparatide (within the past year)\r\n\r\n               -  Current use of calcium channel blockers\r\n\r\n               -  Current use of digitalis glycosides\r\n\r\n               -  Current or within the past 3 months use of thiazide diuretics\r\n\r\n               -  Current or within the past 3 months use of beta blockers\r\n\r\n          -  Clinical history of osteoporotic fracture (vertebral, hip, distal forearm, humerus, or\r\n             pelvis), or any recent fracture within the past 6 months prior to screening (other\r\n             than fingers, toes and facial fractures, which are all acceptable)\r\n\r\n          -  Evidence of moderate/severe vertebral deformity based on DXA vertebral fracture\r\n             assessment at screening\r\n\r\n          -  Spine or femur neck T-score  -2.5, or 1/3 radius T-score  -3, as they may be\r\n             candidates for standard osteoporosis drugs\r\n\r\n          -  Patients with serum 25-hydroxyvitamin D levels of < 20 ng/ml, in order to ensure\r\n             vitamin D sufficiency\r\n\r\n          -  Resting systolic blood pressure < 120 mm Hg, heart rate < 55 bpm (average of 3\r\n             readings after a 5-minute rest and one minute between readings with an automatic cuff)\r\n      ","sponsor":"Sundeep Khosla, M.D.","sponsor_type":"Other","conditions":"Healthy","interventions":[{"intervention_type":"Drug","name":"Drug: Atenolol 50 MG","description":"50 mg Atenolol daily"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"one placebo daily"}],"outcomes":[{"outcome_type":"primary","measure":"Primary Outcome: Percent change in femur neck bone mineral density (BMD)","time_frame":"Baseline, 24 months","description":"Percent change in femur neck bone mineral density (BMD) by DXA"},{"outcome_type":"secondary","measure":"Secondary Outcomes: Percent changes in lumbar spine and total hip BMD","time_frame":"Baseline, 24 months","description":"Percent changes in lumbar spine and total hip BMD"}]}
{"nct_id":"NCT04978363","start_date":"2021-07-21","phase":"N/A","enrollment":30,"brief_title":"iWalk Hands Free Crutch","official_title":"Effects of a Hands Free Crutch on Walking Stability During Gait","primary_completion_date":"2022-02-11","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-04-20","last_update":"2021-08-06","description":"The proposed study evaluates the effects of a hands free crutch (iWalkFree, Inc.) on walking balance and stability compared to standard crutches. It is expected that the hands free crutch will provide better stability during walking on a level surface and better reported balance confidence compared to standard crutches. In this study, walking stability will be assessed using motion capture data from an infrared camera system with 12 mounted cameras surrounding a level walkway. Balance will be assessed through a self-reported activity-specific balance confidence (ABC) questionnaire. An improved understanding of the effects of the hands free crutch on gait may benefit the future prescription of ambulatory assistive devices. The proposed study may provide insight that can be used by physical therapists and other providers to select the ambulatory assistive device that best meets their patients' needs.","other_id":"202101408","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","intervention_model_description":"All participants will complete all six testing conditions, including:\r\nBOOT (walking boot)\r\nHFC + BOOT (Hands Free Crutch with the walking boot)\r\nSAC + BOOT (Standard Axillary Crutches with the walking boot)\r\nNONE (no device/baseline)\r\nHFC NO BOOT (Hands Free Crutch with no walking boot) and\r\nSAC NO BOOT (Standard Axillary Crutches with no walking boot).\r\nThe order of the four primary conditions will be randomized using an online random number generator (1-4) with:\r\n1=NONE, 2=BOOT only, 3=HFC+BOOT, and 4=SAC+BOOT.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or Female\r\n\r\n          -  Ages: 18 - 45\r\n\r\n          -  Height between 5'2\" and 6'6\"\r\n\r\n          -  Foot size that corresponds to available walking boots\r\n\r\n          -  Healthy individuals without current complaint of lower extremity pain, spine pain,\r\n             open wounds or active infection\r\n\r\n          -  Full active pain free range of motion of the bilateral upper and lower extremities and\r\n             spine\r\n\r\n          -  Able to hop without pain\r\n\r\n          -  Able to perform a full squat without pain\r\n\r\n          -  Able to walk up and down a flight of stairs at normal walking speed without using the\r\n             hand rail\r\n\r\n          -  Able to stand on one leg for at least 30 seconds\r\n\r\n          -  Able to read and write in English and provide written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Weight greater than 270 lbs\r\n\r\n          -  BMI greater than 35\r\n\r\n          -  Maximum thigh circumference at top of the leg greater than 28\"\r\n\r\n          -  Prior medical or neuromusculoskeletal disorders that have limited their participation\r\n             in work or exercise in the last 6 months\r\n\r\n          -  Prior lower extremity injury proximal to the ankle requiring surgery or limiting\r\n             function for greater than 6 weeks\r\n\r\n          -  Prior back pain that recurs or has limited activities for greater than 6 weeks\r\n\r\n          -  Diagnosed moderate or severe brain injury\r\n\r\n          -  Diagnosis of a physical or psychological condition that would preclude testing (e.g.\r\n             cardiac condition, clotting disorder, pulmonary condition)\r\n\r\n          -  Uncorrected visual or hearing impairment(s)\r\n\r\n          -  Require use of an assistive device\r\n\r\n          -  Pregnancy - Per participant self-report. Due to the expected small number of pregnant\r\n             individuals, and resulting inability to account for its effect on resulting outcomes,\r\n             participants will be withdrawn from the study\r\n      ","sponsor":"University of Iowa","sponsor_type":"Other","conditions":"Healthy","interventions":[{"intervention_type":"Device","name":"Device: BOOT","description":"A walking boot is a common type of brace/boot that restricts ankle and foot movement."},{"intervention_type":"Device","name":"Device: HFC","description":"The Hands Free Crutch (HFC) by iWalkFree, Inc. is a novel, ambulatory assistive device that prevents foot and ankle loading while also allowing free use of the arms and hands."},{"intervention_type":"Device","name":"Device: SAC","description":"Standard axillary crutches (SAC) are ambulatory assistive devices, commonly used for lower extremity injuries or surgeries."},{"intervention_type":"Device","name":"Device: HFC+BOOT","description":"The Hands Free Crutch (HFC) by iWalkFree, Inc. is a novel, ambulatory assistive device that prevents foot and ankle loading while also allowing free use of the arms and hands. A walking boot is a common type of brace/boot that restricts ankle and foot movement."},{"intervention_type":"Device","name":"Device: SAC+BOOT","description":"Standard axillary crutches (SAC) are ambulatory assistive devices, commonly used for lower extremity injuries or surgeries. A walking boot is a common type of brace/boot that restricts ankle and foot movement."}],"outcomes":[{"outcome_type":"primary","measure":"Whole Body Angular Momentum-sagittal plane","time_frame":"Baseline","description":"Range of whole-body angular momentum in the sagittal plane during gait using the motion capture system."},{"outcome_type":"secondary","measure":"Whole Body Angular Momentum-transverse and frontal planes","time_frame":"Baseline","description":"Range of whole-body angular momentum in the transverse and frontal planes during gait using the motion capture system."},{"outcome_type":"secondary","measure":"Segmental Angular Momentum-sagittal, transverse and frontal planes","time_frame":"Baseline","description":"Range of segmental angular momentum will be compared in the sagittal, transverse and frontal planes during gait using the motion capture system."},{"outcome_type":"other","measure":"Activity-specific Balance Confidence (ABC) Scale","time_frame":"Baseline","description":"Balance confidence will be assessed using the ABC Scale on 16 activities, using a 0-100% scale (0% = no confidence and 100% = completely confident)."},{"outcome_type":"other","measure":"Numerical Pain Rating Scale","time_frame":"Baseline","description":"Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable."},{"outcome_type":"other","measure":"Participant Device Comfort Score","time_frame":"Baseline","description":"A modified device comfort scale using an 11-point rating overall score (0=Most Uncomfortable; 10=Most Comfortable)."},{"outcome_type":"other","measure":"Participant Device Numerical Score","time_frame":"Baseline","description":"A modified device comfort scale using an 11-point rating scale (0=worst assistive device;10=best assistive device)."},{"outcome_type":"other","measure":"Participant Device Preference","time_frame":"Baseline","description":"The participant will rank in order (1-4) their preference of assistive device: NONE, BOOT, HFC and SAC."}]}
{"nct_id":"NCT04958902","start_date":"2021-07-15","phase":"N/A","enrollment":20,"brief_title":"RESTORE in Patients Who Had COVID-19 and Close Others","official_title":"RESTORE: An Online Self-directed Mental Health Intervention for Individuals Who Had COVID-19 and Close Others","primary_completion_date":"2021-11-01","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2021-11-01","last_update":"2021-07-23","description":"There is considerable need for psychological intervention targeting stressor-related mental health symptoms related to COVID-19. The investigators have developed an online self-directed transdiagnostic intervention to address this need called RESTORE: Recovering from Extreme Stressors Through Online Resources and E-health. The specific aims of this project are to refine and investigate the initial safety, efficacy, and desirability of RESTORE for addressing mental-health symptoms in individuals who have recovered from severe COVID-19 and close others.","other_id":"REB# 21-5394-0","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Experienced a traumatic or extremely stressful experience related to being COVID-19+\r\n             or having a close other who was COVID-19+\r\n\r\n          -  Participants who were COVID+ will be eligible once they are no longer exhibiting\r\n             COVID-19 symptoms and those who were hospitalized will be eligible post-discharge\r\n\r\n          -  Close others will be eligible once their close other with COVID-19 has recovered or if\r\n             their loved one is deceased\r\n\r\n          -   18 years of age\r\n\r\n          -  Scores at above clinical threshold on at least one of: Patient Health Questionnaire-9\r\n             ([PHQ-9] score  10), Generalized Anxiety Disorder Scale-7 ([GAD-7] score  10),\r\n             and/or Posttraumatic Stress Disorder Scale-5 ([PCL-5] score  33)\r\n\r\n          -  Access to a computer or a tablet with high speed internet access, be able to clearly\r\n             see the screen of a computer or tablet, and be fluent in English\r\n\r\n          -  Ability to provide consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Elevated risk of suicide\r\n\r\n          -  Currently enrolled in another intervention or treatment (e.g., cognitive behavioural\r\n             therapy) for stress responses related to the COVID-19 pandemic\r\n      ","sponsor":"University Health Network, Toronto","sponsor_type":"Other","conditions":"Mental Health|PTSD|Anxiety|Depressive Symptoms","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: RESTORE: Recovering from Extreme Stressors Through Online Resources and E-health","description":"RESTORE (www.restoreonline.ca) includes eight e-modules anticipated to be approximately 30-40 minutes each in length and intended to be completed over 4-8 weeks. The modules address cognitive and behavioural factors posited to cause and maintain psychological distress related to the COVID-19 pandemic. These include cognitions about the cause and meaning of stressors related to the pandemic, including self-blame, other blame and hindsight bias, as well as problematic beliefs related to safety, trust, and control. The modules also address the importance of: (1) expressing emotions that are natural to the events of the pandemic (e.g., sadness in the face of loss), (2) working through, rather than avoiding, thoughts, feelings and grief related to the pandemic, and (3) utilizing social supports. The modules consist of written materials, brief videos, and practice assignments delivered through the platform. RESTORE includes guidance via direct messaging and/or brief telephone calls."}],"outcomes":[{"outcome_type":"primary","measure":"Change in self-reported Post Traumatic Stress Disorder (PTSD) symptoms","time_frame":"Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up","description":"The PTSD Checklist-5 (PCL-5); Weathers, Litz, Keane, Palemeri, Marx, & Schnurr, 2013) weekly version will provide a measure of change in self-reported PTSD symptoms over the course of intervention. Items are rated from 0 (not at all) to 4 (extremely). Items are summed to create a total score ranging from 0 to 80. A cutoff score of ≥ 33 can be used for screening for PTSD diagnosis (Weathers et al, 2013)."},{"outcome_type":"primary","measure":"Change in Generalized Anxiety Disorder-7 (GAD-7)","time_frame":"Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up","description":"A brief clinical measure to assess anxiety severity. Each item is rated on a 4-point scale from 0 (not at all) to 3 (nearly every day). A symptom severity score is calculated based on the sum of the 7 items, with scores ranging from 0 to 21. GAD-7 scores of 10 and 15 are the cut-off points for moderate and severe anxiety, respectively (Spitzer et., 2006)."},{"outcome_type":"primary","measure":"Change in Patient Health Questionnaire-9 (PHQ-9)","time_frame":"Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up","description":"A self-report measure of depression symptoms. Each of the 9 items is rated on a 4-point scale, ranging from 0 (not at all) to 3 (nearly every day). Items are summed to produce a total severity score ranging from 0 to 27, with higher scores indicating greater symptom severity. PHQ-9 scores ≥ 10 are considered indicative of moderate levels of depression (Manea et al., 2011)."},{"outcome_type":"secondary","measure":"Change in Perceived Health, Functioning, and Quality of Life (QOL)","time_frame":"Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up","description":"Single items will be used to measure perceived health, work functioning, and quality of life over the past month. Each item is rated on a 5-point scale, ranging from 1 (not at all satisfied/poor) to 5 (extremely satisfied/excellent)."},{"outcome_type":"secondary","measure":"Change in Trauma-Related Guilt Inventory (TRGI)","time_frame":"Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up","description":"The TRGI is a 32-item self-report questionnaire designed to measure guilt experienced as a result of surviving a traumatic event. The inventory includes three scales: guilt cognitions, distress, and global guilt scales."},{"outcome_type":"secondary","measure":"Change in Adapted Brief Grief Questionnaire","time_frame":"Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up","description":"The Adapted Brief Grief Questionnaire is a 5-item self-report measure for screening for complicated grief (Shear et al., 2006). The items deal with difficulty accepting the death, interference in current life, troubling thoughts related to the death, avoidance of reminders of the loss, and feeling distant from others. Each item is scored from 0 to 2 (0 = not at all, 1 = somewhat, 2 = a lot)."},{"outcome_type":"secondary","measure":"Change in Perceived emotional social support","time_frame":"Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up","description":"Perceived Emotional Social Support is a single item measure of emotional of social support received in the past week from family and friends (Stappenbeck et al., 2015). The item is rated on a 5-point Likert scale, with responses ranging from 1 (strongly disagree) to 5 (strongly agree)."},{"outcome_type":"secondary","measure":"Change in Mental Health Seeking Attitudes/Intention Scale","time_frame":"Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up","description":"The Mental Health Seeking Attitudes/Intention Scale is an adapted 3-item measure to assess attitudes toward seeking help from a mental health professional (Hammer, Parent, & Spiker, 2018). Each of the items is rated on a 7-point scale, ranging from 1 (definitely false) to 7 (definitely true)."},{"outcome_type":"other","measure":"Qualitative interviews","time_frame":"Immediately after the intervention","description":"Qualitative interviews will be conducted post-intervention to further assess acceptability and to improve RESTORE content and presentation."},{"outcome_type":"other","measure":"Eligibility and enrolment rates","time_frame":"From screening through to study enrolment.","description":"Feasibility of recruitment measured by percentage of screened individuals who are eligible and percentage of those who screen eligible who are subsequently enrolled."},{"outcome_type":"other","measure":"Intervention adherence","time_frame":"Immediately after the intervention","description":"Adherence to the intervention measured by mean number of completed modules and drop out rate."},{"outcome_type":"other","measure":"Intervention engagement","time_frame":"Immediately after the intervention","description":"Engagement will be measured by mean number of platform log-ins, mean number of module entries and mean number of practice assignment entries."},{"outcome_type":"other","measure":"Client Satisfaction Questionnaire","time_frame":"Immediately after the intervention","description":"At the end of the intervention, participants will complete the Client Satisfaction Questionnaire (Attkisson & Zwick, 1982), which measures client satisfaction with the intervention they received. This short questionnaire consists of 6 items, and each item is rated on a 4-point scale with varying response alternatives (1=poor/no, definitely not/quite dissatisfied to 4=excellent/yes, definitely/very satisfied)."}]}
{"nct_id":"NCT04942457","start_date":"2021-07-07","phase":"N/A","enrollment":60,"brief_title":"Efficacy of Fasting on Hormone Dosage in Fertility Treatment","official_title":"Effects of Fasting on Hormone Dosage in Fertility Treatment in Women With Ovulation Disorders","primary_completion_date":"2022-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-12-31","last_update":"2021-07-12","description":"This exploratory study investigates fasting as a potential supportive therapy in infertility treatment for women undergoing ovulation induction","other_id":"KiWuA","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","intervention_model_description":"There are 3 parallel groups following different nutritional regimes.","sampling_method":"","gender":"Female","minimum_age":25,"maximum_age":38,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Women aged 25 to 38 years\r\n\r\n          -  Unfulfilled desire to have children >1 year\r\n\r\n          -  declaration of consent\r\n\r\n          -  25 kg/m  BMI  35 kg/m\r\n\r\n          -  Successful treatment for ovulation induction in cooperating infertily treatment center\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Language barriers\r\n\r\n          -  Previously known serious mental illness or cognitive impairment\r\n\r\n          -  Patients with anatomical/organic damage and proven uterine abnormalities\r\n\r\n          -  Eating disorders in the medical history\r\n\r\n          -  Serious previous internal diseases\r\n\r\n          -  Lack of internet access\r\n\r\n          -  No consent to randomisation\r\n\r\n          -  Participation in other studies\r\n      ","sponsor":"Charite University, Berlin, Germany","sponsor_type":"Other","conditions":"Sub Fertility, Female|Fertility Disorders|Cycle Disorders Menstrual|Ovulation Disorder|Ovulation Absent|Ovulation Delayed|Ovulation; Failure or Lack of|Sub-fertility","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Fasting","description":"Prolonged fasting for 7-10 days (caloric intake <500 kcal in liquid form)"},{"intervention_type":"Behavioral","name":"Behavioral: Weight-loss","description":"8 x dietary counselling for weight-loss"},{"intervention_type":"Behavioral","name":"Behavioral: Counselling on nutrients","description":"1 x dietary counselling on important nutrients while trying to conceive, usual diet should be maintained"}],"outcomes":[{"outcome_type":"primary","measure":"Cumulative drug dose for ovulation induction","time_frame":"baseline and until end of treatment for ovulation induction (2-6 months)","description":"Cumulative dosage of hormonal therapy for each assisted cycle of ovulation induction"},{"outcome_type":"primary","measure":"Qualitative interview analysis of fasting experience","time_frame":"in time frame of 24 weeks after fasting intervention","description":"individual and focus group interviews"},{"outcome_type":"secondary","measure":"pregancy rate","time_frame":"at baseline, after one month, at end of ovulation induction treatment (2-6 months) and 12 months after baseline","description":"pregnancy rate of the participants"},{"outcome_type":"secondary","measure":"complication rates in pregnancy","time_frame":"12 months after baseline","description":"complication rates monitored by the gynaecologist, if applicable"},{"outcome_type":"secondary","measure":"Hormonal status","time_frame":"at the beginning and end of each ovulatory cycle, for up to 12 months","description":"FSH, LH, Estrogen, Progesteron"},{"outcome_type":"secondary","measure":"HbA1c","time_frame":"baseline and at end of ovulation induction treatment (2-6 months), for up to 12 months","description":"serum parameter"},{"outcome_type":"secondary","measure":"WHO-5","time_frame":"at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline","description":"Quality of life"},{"outcome_type":"secondary","measure":"diet","time_frame":"at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline","description":"questionnaire to examine dietary behaviour"},{"outcome_type":"secondary","measure":"mindfulness","time_frame":"at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline","description":"MAAS-questionnaire, validated questionnaire to examine mindfulness"},{"outcome_type":"secondary","measure":"anxiety and depression","time_frame":"at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline","description":"HADS-questionnaire, validated questionnaire to examine anxiety and depression"},{"outcome_type":"secondary","measure":"current mood","time_frame":"at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline","description":"ASTS-questionnaire, validated questionnaire to examine current mood"},{"outcome_type":"secondary","measure":"experienced stress","time_frame":"at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline","description":"Cohen-stress scale, validated questionnaire to examine experienced stress"},{"outcome_type":"secondary","measure":"physical fitness","time_frame":"at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline","description":"questionnaire to examine physical fitness"},{"outcome_type":"secondary","measure":"quality of relationship","time_frame":"at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline","description":"questionnaire to examine the relationship between the two partners desiring to have a child"},{"outcome_type":"secondary","measure":"psychological stress caused by the unfulfilled desire to have children","time_frame":"at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline","description":"questionnaire to examine the psychological stress caused by the unfulfilled desire to have children"},{"outcome_type":"secondary","measure":"gratitude","time_frame":"at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline","description":"validated questionnaire to examine gratitude"},{"outcome_type":"secondary","measure":"self-efficacy","time_frame":"at baseline, after fasting (1-3 weeks), after one month, at end of ovulation induction treatment (2-6 months)and 12 months after baseline","description":"ASKU, validated questionnaire to examine self-efficacy"},{"outcome_type":"secondary","measure":"abdominal ultrasound after liver wrap","time_frame":"before, during and after the fasting intervention","description":"sonography in a subgroup"},{"outcome_type":"secondary","measure":"rate of ovulations","time_frame":"at baseline, after one month, at end of ovulation induction treatment (2-6 months) and 12 months after baseline","description":"ovulation visible in sonography"},{"outcome_type":"secondary","measure":"liver function parameters","time_frame":"at baseline, after one month, at end of ovulation induction treatment (2-6 months), after 12 months","description":"serum liver enzymes"},{"outcome_type":"secondary","measure":"pyruvate in culture medium of oocytes, if applicable (in case of IVF/ICSI)","time_frame":"after in vitro fertilisation, if applicable during study period of one year","description":"chemical composition of culture medium (pyruvate)"},{"outcome_type":"secondary","measure":"glucose in culture medium of oocytes, if applicable (in case of IVF/ICSI)","time_frame":"after in vitro fertilisation, if applicable during study period of one year","description":"chemical composition of culture medium (glucose)"},{"outcome_type":"secondary","measure":"lactate in culture medium of oocytes, if applicable (in case of IVF/ICSI)","time_frame":"after in vitro fertilisation, if applicable during study period of one year","description":"chemical composition of culture medium (lactate)"},{"outcome_type":"secondary","measure":"Continuous Glucose Monitoring","time_frame":"14 days after baseline","description":"Continuous Glucose Monitoring via CGM-Device in subgroup"},{"outcome_type":"secondary","measure":"Ketone bodies in breath","time_frame":"up to 4 days before, during and up to 7 days after fasting intervention","description":"Breath acetone, in subgroup"}]}
{"nct_id":"NCT04963959","start_date":"2021-07-05","phase":"N/A","enrollment":25,"brief_title":"PBMC Collection for Production of UCAR T Cells","official_title":"A Study on the Collection of Peripheral Blood Mononuclear Cells From Healthy Volunteers for UCAR T Production and Clinical Investigation","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2022-01-31","last_update":"2021-07-15","description":"The objective of the study is to collect peripheral blood mononuclear cells (PBMC) from healthy volunteers for the research and production of UCAR T cells used for Clinical trails.","other_id":"CT0590-CG6011","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Healthy volunteers who signed informed consent form\r\n\r\n          2. Age  18 years and  40 years, male or female, Han nationality.\r\n\r\n          3. Weight: male  50 kg, female  45 kg; 18.5  BMI  30.\r\n\r\n          4. Temperature: 36.3-37.2 (Forehead temperature).\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Those with known respiratory, circulatory, digestive, urinary, blood, immune,\r\n             endocrine disorders or metabolic disorders, neurological diseases, mental illnesses\r\n             and those with a family history;\r\n\r\n          2. Those with known chronic skin diseases, especially infectious, allergic or\r\n             inflammatory systemic skin diseases;\r\n\r\n          3. Those with known allergic diseases or recurrent allergies;\r\n\r\n          4. Those with known malignant tumors or health-affecting benign tumors;\r\n\r\n          5. Two or more physical examination results of blood pressure have shown (except for\r\n             white coat hypertension): systolic blood pressure < 90 or 140mmHg, or diastolic blood\r\n             pressure < 60 or  90 mmHg, or pulse pressure < 30 mmHg, heart rate: < 60 beats/min or\r\n             >100 beats/min;\r\n\r\n          6. Laboratory tests: hemoglobin is abnormal and has clinical significant; liver and\r\n             kidney function are higher than the normal upper limit and have clinical significance;\r\n             12-lead ECG is abnormal and has clinical significance, or abdominal ultrasound is\r\n             abnormal and has clinical significance, or chest X-ray is abnormal and has clinical\r\n             significance; abnormal coagulation function; increased CRP;\r\n\r\n          7. Those with active or latent hepatitis B or active hepatitis C, or Treponema pallidum\r\n             antibody, or human immunodeficiency virus antibody, or anti-EBV IgM antibody, or\r\n             anti-CMV IgM antibody, or COVID-19 DNA ;\r\n\r\n          8. Recipients of allogeneic tissue and organ or hematopoietic stem cell transplants;\r\n\r\n          9. Those who have undergone resection of vital internal organs such as stomach, kidney,\r\n             spleen and lung;\r\n\r\n         10. Those who have undergone minor surgery within last 3 months, such as appendectomy and\r\n             ophthalmic surgery; those who have undergone major surgery within 1 year, such as\r\n             surgical treatment for gynecological benign tumors or superficial benign tumors;\r\n\r\n         11. Women who are pregnant, or have an abortion within last 6 months or gave childbirth\r\n             within 1 year;\r\n\r\n         12. Those whose upper respiratory tract infection has recovered for less than 1 week, or\r\n             pneumonia has recovered for less than 3 months;\r\n\r\n         13. Those whose acute pyelonephritis has recovered for less than 3 months, or those with\r\n             acute exacerbation of urinary calculi;\r\n\r\n         14. Those who have been injured or wound-contaminated by equipment contaminated by blood\r\n             or tissue fluids, or who have got a tattoo for less than 1 year;\r\n\r\n         15. Those who have received whole blood and blood component transfusion within 1 year;\r\n\r\n         16. Those who have received the last dose of live attenuated vaccines within 2 weeks, or\r\n             have received the last dose of rubella live vaccine within 4 weeks;\r\n\r\n         17. Those who have received the last dose of rabies vaccines after being bitten by an\r\n             animal within 1 year;\r\n\r\n         18. Those who have received the last dose of antitoxin or immune serum injection within 4\r\n             weeks, or those who have received the last dose of hepatitis B human immunoglobulin\r\n             injection within 1 year;\r\n\r\n         19. Those who have participated in clinical trials within 3 months, or try to participate\r\n             in other intervention trials during the study.\r\n\r\n         20. Those who are considered by the investigator as unsuitable for participating in the\r\n             study.\r\n      ","sponsor":"The First Affiliated Hospital of Soochow University","sponsor_type":"Other","conditions":"Peripheral Blood Mononuclear Cell","interventions":[{"intervention_type":"Device","name":"Device: Peripheral blood mononuclear cell apheresis","description":"mononuclear cell donation for tumor immunotherapy study of UCAR-T cells"}],"outcomes":[{"outcome_type":"primary","measure":"The number of peripheral blood mononuclear cells (PBMC","time_frame":"2 year"}]}
{"nct_id":"NCT04921111","start_date":"2021-07-02","phase":"Phase 1","enrollment":240,"brief_title":"A Phase I Safty and Immunogenicity Study of SCT1000 in Healthy Women Aged 18 to 45 Years","official_title":"A Randomized, Double-Blind, Controlled (Positive and Placebo) Phase I Clinical Trial to Estimate Safty and Immunogenicity of the SCT1000 in Healthy Women Aged 18 to 45 Years","primary_completion_date":"2022-07-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-10-31","last_update":"2021-09-17","description":"A phase 1 random, double blind, positive and placebo control trail was conducted in 120 healthy women in the arm A: 18-26 years old and Arm B: 27-45 years old. The 40 subjects to be inoculated with low, middle, and high dose vaccinefirst in sequence if there was no safety issue. In each dose group SCT1000 : placebo: positive =3:1:1.Two arms can be recruited at the same time. If the DSMB assessment shows that the adverse events of a certain dose group meet the criteria of suspension / termination, the dose group will be suspended / terminated, and the vaccination of this dose group or higher dose group will not be carried out, and the study of other dose groups will continue. If this happens at a low dose, the study will be suspended / terminated.","other_id":"SCT1000-01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Female aged between 18 and 45 years at the first vaccination;\r\n\r\n          -  Be able to understand and comply with the request of the protocol, and sign written\r\n             informed consent;\r\n\r\n          -  Be able to read, understand and complete diary card;\r\n\r\n          -  According to the medical history and the results of physical examination and\r\n             laboratory examination, the subjects were judged to be in good health\r\n\r\n          -  Women who agree to use effective contraception throughout the study period\r\n\r\n        Exclusion Criteria:\r\n\r\n        Exclusion criteria of first injection\r\n\r\n          -  History of HPV positive\r\n\r\n          -  History of drug abuse, alcohol abuse or dependence in the last year\r\n\r\n          -  History of severe allergy (e.g., anaphylaxis and other significant reaction) to any\r\n             previous vaccines, or allergy to any of the components of investigational vaccine\r\n\r\n          -  People with low immune function may be diagnosed with congenital or acquired\r\n             immunodeficiency, HIV infection, lymphoma, tuberculosis, leukemia, systemic lupus\r\n             erythematosus, rheumatoid arthritis, inflammatory bowel disease or other autoimmune\r\n             conditions\r\n\r\n          -  People whose spleen has been removed\r\n\r\n          -  People received the following immunosuppressive therapy in the past year:\r\n             radiotherapy, cyclophosphamide, imidazolidine, methotrexate, chemotherapy,\r\n             cyclosporine, leflunomide, tumor necrosis factor-  Antagonists, monoclonal antibody\r\n             therapy, intravenous immunoglobulin, anti lymphocyte serum, or other known therapies\r\n             that interfere with immunity;\r\n\r\n          -  People are receiving systemic corticosteroid therapy, or received two or more courses\r\n             of high-dose corticosteroids for one week one year before enrollment (nasal inhaled\r\n             corticosteroids or topical corticosteroids can not be excluded);\r\n\r\n          -  People receiving any immunoglobulin products or blood products within the first 3\r\n             months, or planning to receive similar products during the study period;\r\n\r\n          -  Inactivated vaccine was inoculated 14 days before inoculation or attenuated vaccine\r\n             was inoculated 28 days before inoculation;\r\n\r\n          -  Contraindications of intramuscular injection such as thrombocytopenia or other\r\n             coagulation disorders;\r\n\r\n          -  Blood donation within the first week or planned during the study period;\r\n\r\n          -  Egg donation was planned during the study period;\r\n\r\n          -  Participating in other experimental clinical studies;\r\n\r\n          -  Have been vaccinated with HPV vaccine on the market or have participated in clinical\r\n             trials of HPV vaccine;\r\n\r\n          -  Failure to comply with the test procedures or planned relocation during the study;\r\n\r\n          -  Fever occurred within 24 hours before inoculation (axillary temperature > 37 );\r\n\r\n          -  Pregnant women (blood pregnancy test or urine pregnancy test positive) or lactating\r\n             women;\r\n\r\n          -  There is clinical evidence of purulent cervicitis;\r\n\r\n          -  Having serious cardiovascular diseases, such as arrhythmia, conduction block,\r\n             myocardial infarction, severe hypertension, diabetes and drug uncontrollable;\r\n\r\n          -  Acute infection;\r\n\r\n          -  Other abnormalities, which may confuse the results of the study, or which are not in\r\n             line with the maximization of the interests of the subjects, can be excluded by the\r\n             judgment of the investigators.\r\n\r\n        Exclusion criteria for 2nd or 3rd dose vaccination\r\n\r\n          -  having severe allergic reaction during the first or second dose of vaccination and\r\n             cannot continue to be vaccinated according to the judgment of investigators;\r\n\r\n          -  The serious adverse reactions with the previous vaccination were related, and the\r\n             investigators judged that they could not continue to be vaccinated;\r\n\r\n          -  After the first vaccination, the newly discovered or newly occurred serious medical\r\n             diseases, coagulation dysfunction, etc. can not continue to be vaccinated according to\r\n             the judgment of the investigators;\r\n      ","sponsor":"Sinocelltech Ltd.","sponsor_type":"Industry","conditions":"HPV Infection Vaccine Safety SCT1000","interventions":[{"intervention_type":"Drug","name":"Drug: SCT1000","description":"Recombinant 14 valent human papillomavirus vaccine (6,11,16,18,31,33,35,39,45,51,52,56,58,59) (insect cells)"},{"intervention_type":"Drug","name":"Drug: Gardasil9","description":"Recombinant 9 or 4 valent human papillomavirus vaccine"},{"intervention_type":"Drug","name":"Drug: placebo","description":"aluminium phosphate"},{"intervention_type":"Drug","name":"Drug: Gardasil","description":"Recombinant 4 valent human papillomavirus vaccine"}],"outcomes":[{"outcome_type":"primary","measure":"Occurrence of local reaction AEs","time_frame":"Up to 7 days following each dose","description":"Occurrence of local reaction AEs up to 7 days following each dose"},{"outcome_type":"primary","measure":"Occurrence of systemic AEs","time_frame":"Up to 7 days following each dose","description":"Occurrence of systemic AEs up to 7 days following each dose"},{"outcome_type":"primary","measure":"Occurrence of AEs","time_frame":"From dose1 to 30 days after each dose","description":"Occurrence of AEs from dose1 to 30 days after each dose"},{"outcome_type":"secondary","measure":"Occurrence of SAEs","time_frame":"From dose1 to 30 days after each dose and from dose1 to 12 months after first dose","description":"Occurrence of SAEs from dose1 to 30 days after each dose and from dose1 to 12 months after first dose"},{"outcome_type":"secondary","measure":"Abnormal hematology and chemistry laboratoty values 3 days after each dose","time_frame":"3 days after each dose","description":"Changes in laboratory test indicators (including white blood cell count, lymphocyte count, neutrophils, platelets, hemoglobin, ALT, AST, total bilirubin, fasting blood glucose, creatinine) 3 days after vaccination"}]}
{"nct_id":"NCT04901104","start_date":"2021-07-01","enrollment":900,"brief_title":"Long-term Prognosis of Patients With Sepsis After Immunotherapy","official_title":"Long-term Prognosis After Thymosin Alpha 1 Treatment in Patients With Sepsis: A Multicenter Cohort Study","primary_completion_date":"2026-12-31","study_type":"Observational [Patient Registry]","rec_status":"Not yet recruiting","completion_date":"2027-03-31","last_update":"2021-05-25","description":"Current clinical studies of thymosin 1 for sepsis have focused on short-term outcomes (28-day or 90-day mortality), and lack of clinical data on long-term outcomes (3 year mortality) of patients with sepsis after immunotherapy. Based on the preliminary clinical study (NCT02867267), this study will conduct long-term follow-up for sepsis patients to provide data support for the long-term prognosis of immunotherapy.","other_id":"Long-term prognosis in sepsis","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","population":"Sepsis patients who discharged from hospital after recovery in the TESTS study","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Sepsis patients in the TESTS study Patients who discharged from hospital after\r\n             recovery\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  None\r\n      ","sponsor":"Sun Yat-sen University","sponsor_type":"Other","conditions":"Long-term Effects of Thymosin Alpha 1 Treatment","interventions":[{"intervention_type":"Drug","name":"Drug: Thymosin Alpha1","description":"Drug interventions have been done in previous clinical studies"}],"outcomes":[{"outcome_type":"primary","measure":"three years mortality","time_frame":"3 years","description":"Mortality rate of patients treated with thymosin α1 or placebo within 3 years"},{"outcome_type":"secondary","measure":"Recurrence rate of sepsis","time_frame":"5 years","description":"Percentage of recurrent sepsis within 5 years of discharge sepsis patients"},{"outcome_type":"secondary","measure":"one year mortality","time_frame":"1 year","description":"Mortality rate of patients treated with thymosin α1 or placebo within 1 year"},{"outcome_type":"secondary","measure":"Five years mortality","time_frame":"5 years","description":"Mortality rate of patients treated with thymosin α1 or placebo within 5 years"},{"outcome_type":"secondary","measure":"short form 36 questionnaire","time_frame":"1 year","description":"Quality of life of sepsis patients after 1 year of thymosin α1 or placebo treatment"}]}
{"nct_id":"NCT04697849","start_date":"2021-07-01","phase":"N/A","enrollment":130,"brief_title":"Functional and Cognitive Rehabilitation of Hoarding Disorder","official_title":"Functional and Cognitive Rehabilitation of Hoarding Disorder","primary_completion_date":"2024-12-03","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2025-03-31","last_update":"2021-07-14","description":"Hoarding Disorder (HD) is serious and disabling in Veterans. Present in up to 7% of Veterans and even higher symptom rates in older Veterans; HD contributes to functional impairment and poor quality of life. Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) has shown promising functional improvement and symptom reduction. To reduce burdens and barriers to implementation of CREST, the proposed project will individualize CREST based on cognitive testing and participant preferences, provide all care in the participant's home through telemedicine and home visits, and shorten the timeframe of treatment. A randomized controlled trial comparing 24 sessions of Personalized-CREST to case management for 130 adult Veterans with HD is proposed. Multifaceted functional and recovery outcomes including quality of life, HD severity, and sustained recovery outcomes will be examined throughout treatment and follow-up. By advancing the knowledge of the rehabilitative care of HD, we can interrupt the trajectory of this chronic and debilitating condition.","other_id":"D3367-R","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","intervention_model_description":"The Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) intervention provides compensatory cognitive strategies to address the executive dysfunction typical of individuals with HD, and then uses exposure therapy to reduce the distress associated with discarding items. CREST will be compared to case management for hoarding symptoms.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Veterans age 18 and older\r\n\r\n          -  voluntary informed consent for participation\r\n\r\n          -  DSM-5 diagnosis of HD as measured by the Structured Interview for Hoarding Disorder\r\n\r\n          -  HD as a primary diagnosis, and 5) stable on medications for at least 6 weeks\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  current psychosis or mania as measured by the Mini-International Neuropsychiatric\r\n             Interview\r\n\r\n          -  current or history of any neurodegenerative disease\r\n\r\n          -  concurrent participation in any form of exposure-based psychotherapy\r\n\r\n               -  suicide ideation will be monitored by the clinicians during sessions and VA\r\n                  standard suicide measure will be completed at all assessment points\r\n      ","sponsor":"VA Office of Research and Development","sponsor_type":"U.S. Fed","conditions":"Hoarding Disorder","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Cognitive Rehabilitation and Exposure/Sorting Therapy","description":"Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) provides training in compensatory cognitive strategies to address the executive dysfunction typical of individuals with HD, then helps reduce the distress associated with discarding items via exposure therapy."},{"intervention_type":"Behavioral","name":"Behavioral: Case Management","description":"Case Management (CM). CM is the most widely available and utilized intervention for HD and is considered standard of care. This form of treatment involves managing the functional, housing, and legal ramifications of HD. Additionally, CM often involves assistance with economic, health, and social resources while providing support for the client."}],"outcomes":[{"outcome_type":"primary","measure":"World Health Organization Disability Assessment Schedule (WHODAS 2.0) Change","time_frame":"Baseline, 1.5 months, 3 months, and 9 months","description":"World Health Organization Disability Assessment Schedule (WHODAS 2.0) A 36-item, six domain (Cognitive, Mobility, Self-Care, Getting Along, Household, Work, Participation) assessment instrument developed by the World Health Organization (WHO) to provide a standardized method for measuring health and disability across cultures. The WHODAS has demonstrated high internal consistency, domain-specific reliability, and concurrent validity with similar disability measures. Total scores range from 0-100. Change is being assessed from baseline to post-treatment and again at follow-up."},{"outcome_type":"primary","measure":"Activities of Daily Living in Hoarding Scale Change","time_frame":"Baseline, 1.5 months, 3 months, and 9 months","description":"The Activities of Daily Living in Hoarding Scale is a 15-item measure that assesses functional impairments in daily activities due to hoarding behavior. The ADL-H assesses a respondents' ability to fulfill basic needs such as prepare meals, utilize appliances and furniture, move around the home, and exit the home. The ADL-H has demonstrated good test-retest reliability, internal and inter-rater reliability, and convergent and discriminant validity. Total scores range from 0-75. Change is being assessed from baseline to post-treatment and again at follow-up."},{"outcome_type":"primary","measure":"PROMIS-43 Profile v2.1 Change","time_frame":"Baseline, 1.5 months, 3 months, and 9 months","description":"The PROMIS-43 Profile v2.1 consists of a fixed collection of 6-item sets to assess global health and functioning (in physical, mental, and social domains). The PROMIS-43 assesses anxiety, depression, fatigue, pain interference, pain intensity (1-item), physical functioning, sleep disturbance, and ability to participate in social roles and activities. Substantial evidence supports the validity, reliability, and responsiveness to change of the PROMIS measures among adults with and without medical and mental health conditions. Total scores range from 0-275. Change is being assessed from baseline to post-treatment and again at follow-up."},{"outcome_type":"primary","measure":"Quality of Life in Neurological Disorders (Neuro-QoL) Positive Affect and Well-Being Short form Change","time_frame":"Baseline, 1.5 months, 3 months, and 9 months","description":"Quality of Life will be assessed using the Quality of Life in Neurological Disorders (Neuro-QoL) Positive Affect and Well-Being Short form, a 9-item self-report measure that assesses sense of well-being, life satisfaction, purpose, and learning. The Neuro-QoL has demonstrated good internal consistency, test-retest reliability, and convergent and discriminant validity. A total score will be used for analyses and scores range from 0-9. Change is being assessed from baseline to post-treatment and again at follow-up."},{"outcome_type":"secondary","measure":"Savings Inventory-Revised (SI-R) Change","time_frame":"Baseline, 1.5 months, 3 months, and 9 months","description":"Hoarding symptom severity will be measured using the Savings Inventory-Revised (SI-R), a 23-item self-report measure used to assess common HD symptoms. Subtests include excessive clutter, compulsive acquisition, and difficulty discarding. The SI-R has demonstrated good internal consistency, concurrent validity, divergent validity, and test-retest reliability in clinical samples with HD. The total score will be used for analyses and scores range from 0-92. Change is being assessed from baseline to post-treatment and again at follow-up."},{"outcome_type":"secondary","measure":"Clutter Image Rating Scale (CIR) Change","time_frame":"Baseline, 1.5 months, 3 months, and 9 months","description":"The Clutter Image Rating Scale (CIR) is a measure using a series of 9 photographs each of a kitchen, living room, and bedroom with varying levels of clutter. Participants and the rater independently select the photograph that most closely resembles each of the three rooms in the home. Internal consistency, test-retest reliability, and inter-rater reliability for the CIR were high, as well as correlations with validated hoarding measures. Scores range from 0-18. Change is being assessed from baseline to post-treatment and again at follow-up."}]}
{"nct_id":"NCT04915196","start_date":"2021-07-01","enrollment":20,"brief_title":"Tolerability of Iron Therapy in Women With AUB","official_title":"Investigation of Efficacy and Gastrointestinal Tolerability of Liposomally Bound Iron Compared to Ferrous Sulphate in Women With Abnormal Uterine Bleeding","primary_completion_date":"2022-07-01","study_type":"Observational","rec_status":"Not yet recruiting","completion_date":"2022-07-01","last_update":"2021-06-07","description":"Telephone surveys of female patients using liposomally-bound iron and traditional iron sulphate preparations for the management of iron deficiency anemia to determine gastrointestinal tolerability.","other_id":"REB20-1546","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"Female","minimum_age":18,"maximum_age":50,"population":"Nongravid women age 18-50 yo that have been diagnosed with iron deficiency secondary to\r\n        abnormal uterine bleeding","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosed with iron deficiency secondary to abnormal uterine bleeding\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Postmenopausal, premenarchal and pregnant women are excluded, as they do not have\r\n             regular uterine bleeding associated with menses.\r\n      ","sponsor":"University of Calgary","sponsor_type":"Other","conditions":"Iron Deficiency Anemia|Abnormal Uterine Bleeding","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Liposomally-bound Iron","description":"Ferric pyrophosphate microencapsulated in liposomal form is an over the counter natural health product approved by Health Canada and commonly used for iron replacement. If this product is prescribed as part of usual management of iron deficiency and patients consent to participation they will be contacted by telephone survey of gastrointestinal tolerability."}],"outcomes":[{"outcome_type":"primary","measure":"Subjective tolerability of oral administration","time_frame":"8 weeks","description":"Survey of gastrointestinal reactions to iron replacement"},{"outcome_type":"secondary","measure":"Hemoglobin","time_frame":"8 weeks","description":"Relative change of hemoglobin"},{"outcome_type":"secondary","measure":"Hematocrit","time_frame":"8 weeks","description":"Relative change of hematocrit"},{"outcome_type":"secondary","measure":"Ferritin","time_frame":"8 weeks","description":"Relative change of ferritin"}]}
{"nct_id":"NCT04933526","start_date":"2021-07-01","phase":"Phase 4","enrollment":118,"brief_title":"The Efficacy and Safety of Switching to Flumatinib Versus Dasatinib After Imatinib-related Low-grade Adverse Events in CML-CP Patients","official_title":"The Efficacy and Safety of Switching to Flumatinib Versus Dasatinib After Imatinib-related Low-grade Adverse Events in Patients With Chronic Myeloid Leukemia in Chronic Phase: an Randomized Controlled Trial.","primary_completion_date":"2023-04-30","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2023-06-30","last_update":"2021-06-21","description":"The purpose of this study is to explore the efficacy and safety of switching to flumatinib versus dasatinib after imatinib-related low-grade adverse events in patients with chronic myeloid leukemia in chronic phase (CML-CP) in China. This is a post-marketing, interventional, double-arm, prospective, open-label, randomized controlled study in CML-CP patients in China. Patients will be recruited consecutively from the study sites during the enrollment period. The enrolled patients will be given flumatinib or dasatinib under the conditions of informed consent and frequent monitoring according to the clinical guideline.","other_id":"20210609","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age  18 years;\r\n\r\n          -  Diagnosis of CML-CP with Ph+;\r\n\r\n          -  ECOG 0, 1, or 2;\r\n\r\n          -  Patients with imatinib-related Low-grade Adverse Events for more than 12 months and AE\r\n             lasting for at least 2 months, or relapsed at least 3 times in the past 12 months;\r\n\r\n          -  Ability to provide written informed consent prior to any study related screening\r\n             procedures being done\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Previously documented T315I mutation;\r\n\r\n          -  Previous treatment with any other tyrosine kinase inhibitor except for imatinib;\r\n\r\n          -  Prior accelerated phase or blast phase CML;\r\n\r\n          -  Loss of CHR or cytogenetic response\r\n      ","sponsor":"Shenzhen Second People's Hospital","sponsor_type":"Other","conditions":"Chronic Myeloid Leukemia in Chronic Phase","interventions":[{"intervention_type":"Drug","name":"Drug: Flumatinib","description":"Flumatinib 600mg QD orally form 1 to 12 months"},{"intervention_type":"Drug","name":"Drug: Dasatinib","description":"Dasatinib 100mg QD orally form 1 to 12 months"}],"outcomes":[{"outcome_type":"primary","measure":"Change of (CTCAE grading scale) of imatinib related chronic low grade non hematologic Adverse Event after switch to treatment with flumatinib or dasatinib at 3 months.","time_frame":"3 months"},{"outcome_type":"secondary","measure":"Rate of a Major Molecular Response (MMR) after the switch to flumatinib or dasatinibin the therapy.","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Time to optimal imatinib-related adverse event improvement.","time_frame":"12 months"}]}
{"nct_id":"NCT04847804","start_date":"2021-07-01","enrollment":200,"brief_title":"Large-scale COVID-19 Population Screening","official_title":"Large-scale Population Screening of Pooled Viral Nucleic Acid Samples Using Concurrent Isothermal Amplification and Electrochemical Detection for Novel Infectious Diseases on a Disposable Chip","primary_completion_date":"2024-05-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2024-05-31","last_update":"2021-08-27","description":"Infectious diseases pose a threat to the life of individuals worldwide. The pandemic has highlighted the need to develop an innovative and cost- effective large population-based screening methodology. The investigators propose a two-fold improvement barcode-labeled testing strategy specifically for pooled samples. This platform combines isothermal amplification and real-time electrochemical detection; electroactive modified loop probes will be used in the amplification step for barcode readout. This method enables four samples pooled detection at the same time. This platform will be integrated into a disposable microfluidic chip that allows minimal human intervention during the process to realize a massively parallel screening platform for infectious disease pathogens. Objectives 1. To develop a sensing method for concurrent electrochemical-tag coded isothermal amplification and real-time electrochemical detection; 2. To design a molecular strategy to barcode four individual samples so that they can be pooled together and to simultaneously amplify and identify a positive individual, if any, from the pooled sample. 3. To fabricate a microfluidic device integrating the sample processor and barcoding module with the nucleic acid amplification and detection step for large-scale population screening of up to 100 individuals. 4. To validate the performance of the prototype using clinical specimens and benchmark it against the detection data from commercially available testing equipment.","other_id":"CRE2021.188","observational_model":"Case-Control","time_perspective":"Cross-Sectional","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"Adult patients hospitalized at the Prince of Wales Hospital who have received testing for\r\n        SARS-CoV-2 PCR","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients hospitalized at the Prince of Wales Hospital who have received testing for\r\n             SARS-CoV-2 PCR\r\n\r\n          -  Age 18 years or above\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Mentally incompetent to provide informed consent\r\n      ","sponsor":"Hong Kong University of Science and Technology","sponsor_type":"Other","conditions":"Covid19","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Diagnostic test","time_frame":"through study completion, an average of 3 years","description":"The sensitivity, specificity, and positive and negative predictive values will be calculated for futher data analysis"}]}
{"nct_id":"NCT04690036","start_date":"2021-07-01","phase":"Early Phase 1","enrollment":20,"brief_title":"PD-1 Antibody for Reactive EBV After BMT","official_title":"Reactivation of EBV for Patients With CAEBV and EBV Associated HLH After Transplantation","primary_completion_date":"2023-01-01","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2023-01-01","last_update":"2021-06-29","description":"PD-1 antibody for reactivation of EBV after transplantation in patients with CAEBV/EBV-HLH","other_id":"PD-1,reactive EBV","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Meet hemophagocytic lymphohistiocytosis (HLH)-04 diagnostic criteria; EBV-DNA in\r\n             peripheral blood or EBER in tissue were positive, patients were diagnosed with EBV\r\n             associated HLH (EBV-HLH). Chronic active EBV infection (CAEBV) was diagnosed by WHO\r\n             criteria.\r\n\r\n          2. Undergo allo-HCT, have achieved full chimerism\r\n\r\n          3. Age >18 years old, gender is not limited.\r\n\r\n          4. After transplantation, EBV was reactivated and EBV-DNA was positive in blood\r\n\r\n          5. No secondary graft failure. (After grafted, ANC <0.5*10^9/l,PLT <10*10^9/l)\r\n\r\n          6. No uncontrollable infection\r\n\r\n          7. Withdraw immunosuppressor, no graft-versus-host disease was observed.\r\n\r\n          8. Before the start of the study, aminopherase (ALT/AST) and total bilirubin were normal.\r\n             Serum creatinine  1.5 times the upper limit of Normal (ULN); No thyroid dysfunction.\r\n             The left ventricular ejection fraction (LVEF) was normal.\r\n\r\n          9. Informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Allergic to toripalimab\r\n\r\n          2. Serious immunoreaction: myocardial damage, hepatitis, pneumonia\r\n\r\n          3. Central nervous system symptoms\r\n\r\n          4. Serious mental illness;\r\n\r\n          5. Active bleeding of the internal organs\r\n\r\n          6. Pancreatitis history. Patients unable to comply during the trial and/or follow-up\r\n             phase;\r\n\r\n          7. Participate in other clinical research at the same time.\r\n      ","sponsor":"Beijing Friendship Hospital","sponsor_type":"Other","conditions":"PD-1|EBV Infection|Transplant","interventions":[{"intervention_type":"Drug","name":"Drug: toripalimab injection","description":"when EBV-DNA is positive after allo-HCT, and EBV infected T/NK cell, one dose of toripalimab 3mg/kg would be used, the same dose would be repeated 4 weeks later."}],"outcomes":[{"outcome_type":"primary","measure":"EBV-DNA turn negative","time_frame":"4 weeks after PD-1 antibody was used","description":"after treatment, the EBV-DNA copies can not be detected in peripheral blood"},{"outcome_type":"secondary","measure":"treatment-related adverse events as assessed by CTCAE v5.0","time_frame":"4 weeks after PD-1 antibody was used","description":"Adverse events including thyroid function，liver function damage, myelosuppression, infection, bleeding and so on"},{"outcome_type":"other","measure":"Survival","time_frame":"1 year","description":"From enrollment until death or the end of the experiment"}]}
{"nct_id":"NCT04486846","start_date":"2021-06-30","phase":"N/A","enrollment":0,"brief_title":"Electronic Post-Treatment Surveillance Program for Prostate Cancer Survivors (eHealth)","official_title":"Evaluation of an Electronic Post-Treatment Surveillance Program for Prostate Cancer Survivors (eHealth)","primary_completion_date":"2022-03-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2022-03-31","last_update":"2021-06-10","description":"The purpose of this single institution pilot study is to determine the feasibility of implementing an eHealth prostate cancer surveillance program through the eVisit electronic medical record patient portal. The investigators will assess patient compliance and satisfaction with eVisit follow up care in lieu of in person clinic visits.","other_id":"Pro00104751","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Health Services Research","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -   18 years old with histologically confirmed prostate cancer\r\n\r\n          -  Completed curative intent treatment to the prostate +/- pelvis\r\n\r\n          -  Deemed to be \"without evidence of active disease\" by treating provider with at least 1\r\n             follow up visit 3 or more months after treatment completion\r\n\r\n          -  MyChart account or willingness to open account\r\n\r\n          -  Access to the internet\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Documented extrapelvic metastases\r\n\r\n          -  PSA meeting definition of recurrence (>0.2 ng/ml for prostatectomy patients or nadir +\r\n             2 ng/ml for radiation patients) and rising with doubling time less than 1 year\r\n      ","sponsor":"Duke University","sponsor_type":"Other","conditions":"Prostate Cancer","interventions":[{"intervention_type":"Other","name":"Other: eVisit","description":"electronic surveillance program in lieu of in-person clinic visit"}],"outcomes":[{"outcome_type":"primary","measure":"Proportion of patients who complete all scheduled eVisits at the end of follow-up","time_frame":"12 months","description":"Defined as completion of labwork and at least 80% of the questions asked at each eVisit"},{"outcome_type":"secondary","measure":"Feasibility of enrollment to the eVisit program","time_frame":"12 months","description":"Defined as the percentage of patients who are approached for eVisit and ultimately enroll"},{"outcome_type":"secondary","measure":"eVisit participant reported satisfaction","time_frame":"12 months","description":"Reported as the summary score from validated Brief Patient Satisfaction 10-item scale instrument assessed from \"1/strongly agree\" through \"5/strongly disagree\""},{"outcome_type":"secondary","measure":"Number of participants with cancer treatment related toxicities","time_frame":"12 months","description":"Defined specifically as CTCAE Grade 2 or higher GI, GU, hormonal, and sexual toxicities"},{"outcome_type":"secondary","measure":"Number of eVisit participants with cancer recurrence","time_frame":"12 months","description":"Defined as biochemical progression (PSA >0.2 ng/ml for prostatectomy patients or nadir + 2 ng/ml for radiation patients) or metastasis (by imaging)"},{"outcome_type":"secondary","measure":"Financial impact of the eVisit program on participants compared to in person follow up clinic visits","time_frame":"12 months","description":"Defined by the financial burden assessment completed by participants, scored from \"0/not at all\" through \"4/very much\""},{"outcome_type":"secondary","measure":"Financial impact of the eVisit program on Duke University Hospital (institution) compared to in person follow up","time_frame":"12 months","description":"Defined by percentage of participants/eVisits covered by insurance"},{"outcome_type":"secondary","measure":"Financial impact of the eVisit program on Duke University Hospital (institution) compared to in person follow up","time_frame":"12 months","description":"Defined by qualitative analysis of time commitment for providers"},{"outcome_type":"secondary","measure":"Financial impact of the eVisit program on Duke University Hospital (institution) compared to in person follow up","time_frame":"12 months","description":"Defined by qualitative analysis of reimbursement process"}]}
{"nct_id":"NCT04775381","start_date":"2021-06-30","phase":"Phase 3","enrollment":200,"brief_title":"Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation","official_title":"Study of Total Post-thyroidectomy Hypocalcemia After Preoperative Cholecalciferol Supplementation","primary_completion_date":"2024-03-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2024-03-31","last_update":"2021-08-17","description":"This prospective study evalue the inflence of pre operative vit D3 administration on post operative hypocalcemia in patients undergoing Total thyroidectomy","other_id":"CHRD 2115","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patient  18 years old\r\n\r\n          -  Patient shall be operated on for a total thyroidectomy in one time for any indication\r\n\r\n          -  Written informed consent (IC) obtained\r\n\r\n          -  Patients with affiliation to the social security system\r\n\r\n        Exclusion Criteria:\r\n\r\n         Medical history of : Thyroid or parathyroid surgery Hyperparathyroidism Granulomatosis\r\n        flare-up\r\n\r\n          -  Hypocalcemia, hypercalcemia/ hypercalciuria, or symptom of Hypocalcemia,\r\n             hypercalcemia/ hypercalciuria, not due to thyroid pathologies\r\n\r\n          -  Chronic kidney disease grade 4\r\n\r\n          -  Severe liver failure\r\n\r\n          -  25OHD supplementation within last 3 months before surgery\r\n\r\n          -  Malabsorption syndrome\r\n\r\n          -  Known hypersensitivity to vitamin D\r\n\r\n          -  Medical history of calcic lithiasis\r\n\r\n          -  Pregnant women\r\n\r\n          -  Vulnerable populations (guardianship or trusteeship)\r\n      ","sponsor":"Centre Hospitalier Ren Dubos","sponsor_type":"Other","conditions":"Hypocalcemia","interventions":[{"intervention_type":"Drug","name":"Drug: Vitamin D","description":"Patients will receive a cholecalciferol supplementation added to a fruit juice."}],"outcomes":[{"outcome_type":"primary","measure":"Assessment of the effect of pre-operative cholecalciferol supplementation on the occurrence of post-operative hypocalcemia after total thyroidectomy","time_frame":"At Day 15 after surgery","description":"Measure of the occurrence of serum and / or clinical hypocalcemia.\r\nSerum hypocalcemia is defined by a level of calcemia, corrected for albuminemia, of less than 2.00 mmol / L.\r\nClinical hypocalcemia is defined by the appearance of one of the following signs: sign of Chvostek, sign of Trousseau, paresthesias of the extremities and perioral between surgery and day 15"},{"outcome_type":"secondary","measure":"Comparison of clinical course in both Arm","time_frame":"At 3 month","description":"Clinical course will be measured, for several items, and compared between both groups to see if a significant difference is observed.\r\nItems, considered for comparison, are listed below :\r\nInitial hospital stay (number of days),\r\nnumber of readmission,\r\nadverse event (number)"},{"outcome_type":"secondary","measure":"Comparison of severity of hypocalcemia in both arm","time_frame":"At Day 1, Day 2 and Day 15","description":"The severity of hypocalcemia will be measured in both arm, to see if a significant difference is observed, with items listed below :\r\nCalcemia, corrected for albuminemia, of less than 1.90 mmol / L\r\nthe use of calcium gluconate IV in the first 15 post-operative days)\r\nduration of hypocalcemia's symptoms in the first 15 days postoperative"},{"outcome_type":"secondary","measure":"Comparison of the effect of supplementation on vitamin D deficiency in both arm","time_frame":"At Day 0","description":"Comparison between measured initial value of 25OHD at the inclusion visit to the measured value of 25OHD on the day of the operation in both groups."},{"outcome_type":"secondary","measure":"Comparison of parathyroid activity in both arm","time_frame":"At Day 0 (= Surgery), at Hour 4 post-surgery, Day 2 and Day 15","description":"Parathyroid activity will be evaluated in both group by measuring parathormone (PTH).\r\nHypoparathyroidism being defined by PTH < 15 ng / L."},{"outcome_type":"secondary","measure":"Assessment of the prevalence of definitive hypocalcemia","time_frame":"At Day 15","description":"Collect of the definitive hypocalcemia's numbers in each group"},{"outcome_type":"secondary","measure":"Assessment of the effect of vitamin D supplementation on the occurrence of hypocalcemia in risk groups: hyperthyroidism, cancer, dissection associated with thyroidectomy","time_frame":"At Day 15","description":"Collect of the number of adverse events and serum calcium levels for each participant"}]}
{"nct_id":"NCT04234191","start_date":"2021-06-30","phase":"Phase 2","enrollment":50,"brief_title":"Comparing Rapid Micro-Induction and Standard Induction of Buprenorphine/Naloxone for Treatment of Opioid Use Disorder","official_title":"Comparing Rapid Micro-Induction and Standard Induction of Buprenorphine/Naloxone for Treatment of Opioid Use Disorder: A Randomized Controlled Trial","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2021-12-31","last_update":"2021-06-03","description":"The current first-line treatment for Opioid Use Disorder (OUD) in Canada is buprenorphine/naloxone (bup/nx). The standard induction method of bup/nx requires patients to be abstinent from opioids and thereby experience withdrawal symptoms prior to induction, which can be a major barrier in starting treatment. Rapid micro-induction (micro-dosing) involves the administration of small, frequent does of bup/nx and removes the need for a period of withdrawal prior to the start of treatment. This study aims to compare the effectiveness and safety of rapid micro-induction versus standard induction of bup/nx in patients with OUD.","other_id":"H19-03254","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":19,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Opioid Use Disorder (OUD) as defined by the Diagnostic and Statistical Manual of\r\n             Mental Disorders-5 diagnostic criteria;\r\n\r\n          2. Individuals seeking Opioid Agonist Treatment (OAT);\r\n\r\n          3. Be 19 years of age or older;\r\n\r\n          4. Be willing and able to adhere to the study protocol and follow-up schedule;\r\n\r\n          5. Be able to provide written informed consent to participate in the clinical trial.\r\n\r\n          6. If female and of childbearing potential, agree to use an effective method of birth\r\n             control approved by the study investigators throughout the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Diagnosis of severe medical or psychiatric conditions contraindicated for\r\n             buprenorphine/naloxone or hydromorphone treatment;\r\n\r\n          2. Anticipated deterioration of health due to discontinuation of medications that are\r\n             contraindicated with buprenorphine/naloxone and/or hydromorphone;\r\n\r\n          3. Positive pregnancy test for women of childbearing potential;\r\n\r\n          4. Not experiencing mild to moderate opioid withdrawal after the last dose of methadone;\r\n\r\n          5. Positive urine test for methadone;\r\n\r\n          6. Known allergy or sensitivity to buprenorphine/naloxone and/or hydromorphone;\r\n\r\n          7. Anticipation that the patient may need to initiate pharmacological treatment during\r\n             the trial that is deemed unsafe by the study physician or could prevent study\r\n             completion;\r\n\r\n          8. Unwilling or unable to use an effective method of birth control approved by the study\r\n             investigators throughout the study.\r\n      ","sponsor":"University of British Columbia","sponsor_type":"Other","conditions":"Opioid Use Disorder","interventions":[{"intervention_type":"Drug","name":"Drug: Buprenorphine/naloxone","description":"Buprenorphine/naloxone is an opioid agonist treatment for opioid use disorder. It is administered orally via sublingual tablet form."},{"intervention_type":"Drug","name":"Drug: Hydromorphone","description":"Hydromorphone is an opioid used for managing pain, craving, and withdrawal. It is administered orally via tablet or liquid form; or administered intravenously, subcutaneously, or intramuscularly via liquid form."}],"outcomes":[{"outcome_type":"primary","measure":"Successful induction of bup/nx with low levels of withdrawal","time_frame":"Randomization to Day 3 (Standard Induction Arm) or Day 4 (Rapid Micro-Induction Arm)","description":"This is defined as the following: participants who remain in treatment until they have received a total daily dose of ≥ 12mg of bup/nx (successful induction), and score ≤ 12 on the COWS (low levels of withdrawal) from the time of randomization to when they reach that dose."},{"outcome_type":"secondary","measure":"Illicit drug use","time_frame":"Baseline (both arms), Day 3 (Standard Induction Arm), Day 4 (Rapid Micro-Induction Arm)","description":"Assessed by urine drug screens (UDS)."},{"outcome_type":"secondary","measure":"Drug use behaviour","time_frame":"Baseline (both arms), Day 3 (Standard Induction Arm), Day 4 (Rapid Micro-Induction Arm)","description":"Assessed by the Treatment Outcomes Profile (TOP)."},{"outcome_type":"secondary","measure":"Treatment retention","time_frame":"Day 5","description":"Participants who pick up their prescription of bup/nx on Day 7. Assessed via the pharmacy database."},{"outcome_type":"secondary","measure":"Craving","time_frame":"Baseline to Day 3 (both arms), Day 4 (Rapid Micro-Induction Arm)","description":"Assessed by a Visual analogue scale (0-10 scale)."},{"outcome_type":"secondary","measure":"Pain","time_frame":"Baseline to Day 3 (both arms), Day 4 (Rapid Micro-Induction Arm)","description":"Assessed by a Visual analogue scale (0-10 scale)."},{"outcome_type":"secondary","measure":"Physical health","time_frame":"Baseline (both arms)","description":"Assessed by the health section of the Opiate Treatment Index (OTI)."},{"outcome_type":"secondary","measure":"Client satisfaction","time_frame":"Day 3 (Standard Induction Arm), Day 4 (Rapid Micro-Induction Arm)","description":"Assessed by the Treatment Perceptions Questionnaire (TPQ)."},{"outcome_type":"secondary","measure":"Appearance of adverse events","time_frame":"Randomization to Day 3 (Standard Induction Arm) or Day 4 (Rapid Micro-Induction Arm)","description":"Assessed by an adverse events report form."}]}
{"nct_id":"NCT04917185","start_date":"2021-06-30","phase":"N/A","enrollment":1000,"brief_title":"EA for PAAS: A pRCT","official_title":"Electro-acupuncture for Protracted Amphetamine Abstinence Syndrome : A Pragmatic Randomized Controlled Trial","primary_completion_date":"2022-07-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-12-31","last_update":"2021-06-08","description":"In 2019, around 27 million people worldwide, corresponding to 0.5% of the adult population, have used amphetamine-type stimulants (ATS). More than one-third of these 27 million users of ATS were in East and South-East Asia. ATS are a group of synthetic psychostimulants including methamphetamine, amphetamine, 3,4-methylenedioxymethamphetamine (MDMA, ecstasy) and related substances. Although the biology underlying amphetamine withdrawal syndrome is not fully understood, amphetamine has been shown to produce long-lasting reductions in neuronal expression of dopamine neuronal markers. Abuse of these synthetic psychostimulants can lead to drug addiction, and subsequent withdrawal can cause a series of mental symptoms, such as anxiety, depression, confusion, insomnia, mood disturbances, cognitive impairments, and delusions. Some studies have shown two clear stages of ATS withdrawal syndrome: an acute phase lasting 7-10 days, and a subacute phase lasting a further 2 weeks or more, which is termed called \"Protracted amphetamine abstinence syndrome (PAAS)\". The relevant literature has indicated that the majority of patients with ATS withdrawal disorders can experience depression, cognitive impairments, insomnia, and anxiety, especially during the PAAS stage. These symptoms may affect the treatment and finally lead to a relapse. Nowadays, pharmacological therapies are mostly symptom-targeted and show an ungratified effectiveness for amphetamine-type drugs. There is no a medication approved by Food and Drug Administration for use in the treatment of methamphetamine addiction. Therefore, the treatment of PAAS is essential for the treatment of ATS use disorders. Traditional Chinese medicine (TCM), especially acupuncture, is effective in the treatment of withdrawal symptoms with few side effects. research on acupuncture detoxification originates from the treatment of opioid drug withdrawal. Studies have shown that acupuncture has high efficacy in the treatment of protracted abstinence symptoms after heroin addiction. This study hypothesizes that acupuncture has the same mechanism of action in the treatment of PAAS as in the treatment of protracted opioid abstinence syndrome. Therefore, investigators have designed a real-world-based pragmatic randomized controlled trial (pRCT) to determine the effectiveness of acupuncture in the treatment of PAAS and provide support for clinical decision-making. Investigators conduct a pragmatic randomized controlled trials(pRCT) to observe the effect of acupuncture in a larger sample. It combines the advantages of randomization and real-world data, and the results can provide the best real-world evidence for the assessment of intervention effects or comparative effects.","other_id":"18ZDYF3417","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients meet the diagnostic criteria in the Diagnostic and Statistical Manual of\r\n             Mental Disorders, Fifth Edition (DSM-5) (21);\r\n\r\n          -  A urine test for methamphetamine is negative.\r\n\r\n          -  18-60 years old, male or female, conscious, no aphasia, or mental retardation, primary\r\n             school education or above, and able to understand the contents of the scales and\r\n             cooperate with treatment;\r\n\r\n          -  Did not participate in other clinical trials within 3 months;\r\n\r\n          -  Signed the informed consent from.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Local trauma or infected persons who have received EA;\r\n\r\n          -  Can' not tolerate EA, EA treatment, or allergic to EA needles;\r\n\r\n          -  Pregnant or breastfeeding women;\r\n\r\n          -  Serious disorders of the heart, liver, or kidney, or suicidal tendencies.\r\n      ","sponsor":"Chengdu University of Traditional Chinese Medicine","sponsor_type":"Other","conditions":"Substance Withdrawal Syndrome","interventions":[{"intervention_type":"Other","name":"Other: Electro-Acupuncture","description":"Acupuncture used for thousands years is part of traditional Chinese medicine. We use electro-acupuncture to treat our patients because it is more sufficient than traditional acupuncture and proved effectively treating protracted withdrawal syndrome of opioid use disorder. Paired alligator clips of the EA apparatus will be attached to the needle holders of Shenmen and Neiguan points on both sides. EA stimulation will last for 30 min with a continuous wave of 2/100Hz and intensity of 10-15 mA which patients can stand. All needles will be removed in 30 min and use a dry sterilised cotton ball to press the points in case of bleeding."}],"outcomes":[{"outcome_type":"primary","measure":"Amphetamine Cessation Symptom Assessment","time_frame":"Change from baseline Amphetamine Cessation Symptom Assessment scores at 1 month.","description":"It consists of three subscales, namely, \"anxiety and mood\", \"fatigue\", and \"craving\". Items are scored on a five-point scale ranging from 0 to 4 with higher scores representing more severe Amphetamine Cessation Symptom"},{"outcome_type":"secondary","measure":"Visual Analog Scale","time_frame":"Change from baseline Visual Analog Scale scores at 1 month.","description":"Determining the craving for amphetamine.The scores is from 0 to 10, and the higher scores means the more craving for amphetamine."},{"outcome_type":"secondary","measure":"Hamilton Depression Scale","time_frame":"Change from baseline Hamilton Depression Scale scores at 1 month.","description":"Assessment for depression.And the interpretation of HAMD scores is as follows: <7, no depression; 7-17, mild depression; 17-24, moderate depression; and >24, severe depression."},{"outcome_type":"secondary","measure":"Hamilton Anxiety Scale","time_frame":"Change from baseline Hamilton Anxiety Scale scores at 1 month.","description":"Assessment for anxiety. And the interpretation of HAMA scores is as follows: <7, no anxiety;7-14, mild anxiety; 14-20, moderate anxiety; 21-28, severe anxiety; and >29, extremely severe anxiety."},{"outcome_type":"secondary","measure":"Pittsburgh Sleep Quality Index","time_frame":"Change from baseline Pittsburgh Sleep Quality Index scores at 1 month.","description":"The scores are from 0 to 21.Higher scores reflect worse sleep quality."},{"outcome_type":"secondary","measure":"36-item Short Form Health Survey","time_frame":"Change from baseline 36-item Short Form Health Survey scores at 1 month.","description":"This questionnaire contains 9 parts: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, Mental Health and Reported Health Transition."}]}
{"nct_id":"NCT04669574","start_date":"2021-06-29","enrollment":160,"brief_title":"Assessing Sleep and Circadian Rhythms in Primary Brain Tumors Patients","official_title":"Assessing Sleep and Circadian Rhythms in Primary Brain Tumors Patients: an Observational Study","primary_completion_date":"2022-02-01","study_type":"Observational","rec_status":"Enrolling by invitation","completion_date":"2022-06-01","last_update":"2021-09-05","description":"Background: Sleep disturbances are among the most common and severe symptoms reported by people with primary brain tumors (PBT). Smart wearable devices like Fitbits may be able to give detailed data about people s sleep and circadian rhythms. In this study, researchers will use Fitbits to learn more about sleep disruptions caused by tumors. This might help them design better future treatment and supportive care studies. Objective: To describe sleep disturbances and circadian disruption in people with PBT. Eligibility: English-speaking adults ages 18 and older who have PBT and are enrolled in the NIH study, Evaluation of the Natural History of and Specimen Banking for Patients with Tumors of the Central Nervous System. It is also known as the Natural History Study, trial #16C0151. Design: Participants will be screened over the telephone or in person. They will be asked about their medical history. Their cancer diagnosis will be confirmed through test results and pathology reports. Participants will complete 4 surveys. The surveys take about 20 minutes to complete and will ask about: The quality of their sleep Their ability to fall asleep and stay asleep How the quality of their sleep affects their daily activities Their sleep hygiene and preferences Participants will get a Fitbit. It looks like a watch and is worn on the wrist. They will connect the device to their smart phone to track sleep, heart rate, and activity. They will wear it for 1 month. Participants will keep a daily sleep diary for 1 week. It will be sent via an electronic link. They will also repeat 2 of the surveys. Participation will last for 1 month. ...","other_id":"10000085","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"cohort selection will be from Primary Brain Tumor patients enrolled onto the Natural\r\n        History Study (16C0151) at the Neuro-Oncology Branch and all tumor types and grades are\r\n        eligible.","criteria":"\n        -  INCLUSION CRITERIA:\r\n\r\n          -  Subjects with histologically documented PBT\r\n\r\n          -  PBT patients must be enrolled on the Natural History Study (NHS) trial 16C0151 in the\r\n             Neuro-Oncology Branch (NOB). Note: Concurrent enrollment in other NOB trials is also\r\n             permissible.\r\n\r\n          -  Adults (greater than or equal to 18 years of age) who are English-speaking\r\n\r\n          -  Participants must be able to self-report symptoms\r\n\r\n          -  Ability of subject to understand and the willingness to sign a written consent\r\n             document\r\n\r\n        EXCLUSION CRITERIA:\r\n\r\n        -Participants who are unwilling or unable to synchronize or link their Fitbit smart\r\n        wearable device to their personal smart phone\r\n      ","sponsor":"National Cancer Institute (NCI)","sponsor_type":"NIH","conditions":"Sleep Circadian Rhythms|Chronodisruption","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Number of participants who wore the Fitbit device and complete questionnaires","time_frame":"End of Study","description":"To describe the feasibility of using smart wearable devices, which quantify sleep stages, heart rate and activity, to measure the impact of oncologic therapy on sleep and circadian rhythms in the PBT population across disease trajectory"},{"outcome_type":"secondary","measure":"Measure correlation between physiological sleep data and self-reported sleep questionnaires","time_frame":"End of Study","description":"To access the correlation between physiological sleep data collected from smart wearables with a self-reported sleep disturbance (SD) instruments (PROMIS - Sleep Related Impairment (SRI))."},{"outcome_type":"secondary","measure":"Measure sleep onset latency and sleep quality, efficiency and architecture","time_frame":"End of Study","description":"To assess physiological sleep measurements attained from smart wearables, including daytime sleepiness (as measured by daytime napping duration/number, sleep onset latency [SOL] and Rapid Eye Movement Latency [RL]) and sleep quality (as measured by total sleep time [TST], Wake After Sleep Onset [WASO], Sleep Efficiency [SE] and sleep architecture - Awake, Rapid Eye Movement [REM], Light or Deep Slow Wave Sleep [SWS])"},{"outcome_type":"secondary","measure":"Measure comparability of clinical evaluation and at-home collection with sleep data from self-reported PROMIS questionnaires","time_frame":"End of Study","description":"To determine if reported quality of sleep collected with the PROMIS Sleep Indices are comparable between clinical evaluation and collection at-home."},{"outcome_type":"secondary","measure":"Measure if patient chronotype is more pronounced in individuals with circadian disruption as measured by smart wearables","time_frame":"End of Study","description":"To determine if patient chronotype, as measured by the Morningness-Eveningness Questionnaire (MEQ), are more pronounced in individuals with circadian disruption as measured by smart wearables"},{"outcome_type":"secondary","measure":"Measure if patient chronotype is more pronounced in individuals with sleep disturbance as measured by smart wearables","time_frame":"End of Study","description":"To determine if patient chronotype, as measured by the Morningness-Eveningness Questionnaire (MEQ), are more pronounced in individuals with sleep disturbance as measured by smart wearables"},{"outcome_type":"secondary","measure":"Measure circadian rhythm variables to see if they dampen in patients with moderate to severe levels of sleep disturbances","time_frame":"End of Study","description":"To determine if circadian rhythm variables (Amplitude and Phase onset/offset) are dampened or phase shifted in patients with moderate to severe levels of sleep disturbances (as measured by the MDASI-BT, score of >=5)."}]}
{"nct_id":"NCT04798261","start_date":"2021-06-25","enrollment":600,"brief_title":"Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System","official_title":"STRIKE-PE: A Prospective, Multicenter Study of the Indigo Aspiration System Seeking to Evaluate the Long-Term Safety and Outcomes of Treating Pulmonary Embolism","primary_completion_date":"2024-09-30","study_type":"Observational","rec_status":"Recruiting","completion_date":"2026-03-31","last_update":"2021-08-12","description":"The objective of this study is to evaluate real world long-term functional outcomes, safety and performance of the Indigo Aspiration System for the treatment of pulmonary embolism (PE).","other_id":"18135","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients with acute pulmonary embolism","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Clinical signs and symptoms consistent with acute PE with duration of 14 days or less\r\n\r\n          2. RV/LV ratio  0.9 assessed by diagnostic computed tomographic angiography (CTA) or\r\n             echocardiogram\r\n\r\n          3. Frontline endovascular treatment with the Indigo Aspiration System per IFU\r\n\r\n          4. Patient is  18 years of age\r\n\r\n          5. Informed consent obtained per Institutional Review Board/Ethics Committee requirements\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Contraindication to systemic or therapeutic doses of anticoagulants (e.g. heparin)\r\n\r\n          2. Stage III/IV cancer or cancer which requires active chemotherapy during the course of\r\n             the study\r\n\r\n          3. Known serious, uncontrolled sensitivity to radiographic agents\r\n\r\n          4. Life expectancy < 180 days\r\n\r\n          5. Patients on ECMO\r\n\r\n          6. Pregnant patients\r\n\r\n          7. Current participation in another investigational drug or device study that may\r\n             confound the results of this study. Studies requiring extended follow-up for products\r\n             that were investigational but have since become commercially available are not\r\n             considered investigational studies\r\n\r\n          8. Other medical, social, or psychological conditions that, in the opinion of the\r\n             Investigator, precludes the patient from appropriate consent, could limit the\r\n             patient's ability to participate in the study, including compliance with follow-up\r\n             requirements, or that could impact the scientific integrity of the study\r\n      ","sponsor":"Penumbra Inc.","sponsor_type":"Industry","conditions":"Pulmonary Embolism","interventions":[{"intervention_type":"Device","name":"Device: Indigo Aspiration System","description":"Indigo Aspiration System"}],"outcomes":[{"outcome_type":"secondary","measure":"Functional outcome assessed via 6MWT","time_frame":"90 days post-procedure","description":"Walking distance over a 6 minute period to assess functional capacity"},{"outcome_type":"secondary","measure":"Functional outcome assessed NYHA","time_frame":"90 days post-procedure","description":"Physician assessment of heart failure symptoms and activity level"},{"outcome_type":"secondary","measure":"Incidence of device related SAE(s)","time_frame":"365 days"},{"outcome_type":"secondary","measure":"Any-cause mortality","time_frame":"Within 30 days"},{"outcome_type":"secondary","measure":"Symptomatic PE recurrence","time_frame":"Within 30 days"},{"outcome_type":"primary","measure":"Safety: Composite of major adverse events","time_frame":"48 hours","description":"A composite of device-related death, major bleeding, device-related clinical deterioration, device-related pulmonary vascular injury and device-related cardiac injury"},{"outcome_type":"primary","measure":"Performance: Change in RV/LV Ratio","time_frame":"48 hours post-procedure","description":"Change in RV/LV Ratio (matched imaging pairs CTA or echocardiogram, as available)"},{"outcome_type":"secondary","measure":"Quality of Life assessed via PEmb-QoL","time_frame":"90 days post-procedure","description":"Self-assessment of PE related complaints and daily living limitations (including work and social)"}]}
{"nct_id":"NCT04843306","start_date":"2021-06-24","phase":"N/A","enrollment":20,"brief_title":"Breath-Hold Technique for Pancreatic Stereotactic Body Radiation Therapy (SBRT) Patients","official_title":"\"Real-time Augmented Reality Coaching for the Breath-Hold Technique for Pancreatic SBRT Patients\"","primary_completion_date":"2025-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2025-12-31","last_update":"2021-09-13","description":"The Investigator proposes the development of an extended reality (xR) training platform for patients undergoing radiation treatment for pancreatic cancer. The Investigator wants to investigate the ability of this technology to provide biophysical feedback and coaching during the planning and treatment sessions to help patients with the ABC technique to improve motion management outcomes and reduce treatment related anxiety.","other_id":"J20119","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","intervention_model_description":"This will be a prospective, randomized, and non-blinded trial to assess the benefit of xR technology for patient education, coaching, and comfort during radiation treatment of pancreatic cancer. Prior to any use of the xR platform for patients, the investigators will perform several dry runs with the Radiation Oncology Physics department to confirm the device and platform can be used safely.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Men and women over 18 years of age\r\n\r\n          -  Patients with a histologically confirmed diagnosis of pancreatic cancer with\r\n             borderline resectable or locally advanced disease\r\n\r\n          -  Receiving stereotactic body radiation therapy for pancreatic cancer with active\r\n             breathing control (ABC)\r\n\r\n          -  Able to read and write in English or able to understand/answer study questions and\r\n             instructions with the aid of an interpreter\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who do not provide informed consent\r\n\r\n          -  Patients who chose not to answer the study questions\r\n\r\n          -  Patients who chose not to use the xR device and platform\r\n\r\n          -  Patients with a seizure history\r\n      ","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","sponsor_type":"Other","conditions":"Pancreas Cancer","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Biofeedback","description":"Relaxation coaching will be used in this study."},{"intervention_type":"Behavioral","name":"Behavioral: Active Breathing Control Technique","description":"Active breathing control (ABC) requires patients to reproducibly perform multiple deep-inspiratory breath holds during treatment."}],"outcomes":[{"outcome_type":"primary","measure":"Effectiveness of motion management for SBRT for pancreatic cancer with real-time coaching for the ABC procedure using an augmented reality platform","time_frame":"Up to 3 months from final SBRT session","description":"The mean range of intra-fraction variation (in millimeters) will be used in assessing the effectiveness of motion management. The result will be compared to historical controls in a \"pick the winner\" design."},{"outcome_type":"secondary","measure":"Anxiety of patient with the ABC procedure with real-time coaching using an augmented reality platform during SBRT for pancreatic cancer as assessed by patient reported outcome measures (PROMs)","time_frame":"Up to 3 months from final SBRT session","description":"Patient anxiety will be assessed with PROMs and the mean score for all patients treated in AR mode 1 will be compared to the mean score for all patients treated in AR mode 2. This PROM consists of 20 questions on a 4-point Likert scale to assess patient anxiety with the ABC procedure and total score ranges from 20 to 80 with higher scores signifying greater anxiety with the procedure."},{"outcome_type":"secondary","measure":"Quality of patient confidence with the ABC procedure with real-time coaching using an augmented reality platform during SBRT for pancreatic cancer as assessed by patient reported outcome measures (PROMs)","time_frame":"Up to 3 months from final SBRT session","description":"Patient confidence will be assessed with PROMs and the mean score for all patients treated in AR mode 1 will be compared to the mean score for all patients treated in AR mode 2. This PROM consists of 8 questions on a 5-point Likert scale to assess the patient's confidence in performing the ABC procedure with AR mode 1 or 2, and total score ranges from 0 to 32 with higher score signifying greater confidence."}]}
{"nct_id":"NCT04957680","start_date":"2021-06-21","phase":"N/A","enrollment":400,"brief_title":"Effectiveness and Dissemination of Computer-based Cognitive Behavioral Therapy and Online Stress Management Program for Adolescents","official_title":"Effectiveness and Dissemination of Computer-based Cognitive Behavioral Therapy and Online Stress Management Program for Adolescents","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-12-31","last_update":"2021-07-12","description":"The aim of this study is to investigate the effectiveness of a computer-based Cognitive Behavioral Therapy (CCBT) and online stress management program for adolescents, and identify the characteristics of depressed adolescents that participate in the programs.","other_id":"KBN2021","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":13,"maximum_age":17,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  adolescents that scored above the threshold for mild depression (PHQ, CES-D)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  adolescents with severe depression/neuropsychiatric conditions\r\n      ","sponsor":"Seoul National University Hospital","sponsor_type":"Other","conditions":"Depression","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: CCBT","description":"computer-based treatment program for depressed adolescents"}],"outcomes":[{"outcome_type":"primary","measure":"CES-D","time_frame":"5 week"},{"outcome_type":"primary","measure":"PHQ","time_frame":"5 week"},{"outcome_type":"secondary","measure":"DSM-5 Severity measure for Depression, Child-Adolescent version","time_frame":"5 week"},{"outcome_type":"secondary","measure":"Perceived Stress Scale","time_frame":"5 week"},{"outcome_type":"secondary","measure":"Study Stress Scale","time_frame":"5 week"},{"outcome_type":"secondary","measure":"BAI","time_frame":"5 week"},{"outcome_type":"secondary","measure":"EPQ","time_frame":"5 week"},{"outcome_type":"secondary","measure":"Self-esteem Scale","time_frame":"5 week"},{"outcome_type":"secondary","measure":"PedsQL 4.0","time_frame":"5 week"},{"outcome_type":"secondary","measure":"Homework compliance","time_frame":"5 week"}]}
{"nct_id":"NCT04902573","start_date":"2021-06-17","enrollment":200,"brief_title":"A Trial Monitoring Therapy Pathways of Asthma Patients Treated With an Extrafine ICS/LABA/LAMA Single-inhaler Triple Therapy in a Real-world Setting and Characterizing the Effects on Health-related Out-comes","official_title":"A Multicentre, Prospective, Non-interventional Trial Monitoring Therapy Pathways of Asthma Patients Treated With an Extrafine ICS/LABA/LAMA Single-inhaler Triple Therapy in a Real-world Setting and Characterizing the Effects on Health-related Out-comes","primary_completion_date":"2023-06-30","study_type":"Observational","rec_status":"Recruiting","completion_date":"2023-06-30","last_update":"2021-07-09","description":"TriMaximize, a non-interventional trial aims to collect prospective, longitudinal data from asthma patients under routine care, for whom their treating physician has decided to prescribe Trimbow (beclometasone/formoterol/glycopyrronium).","other_id":"548_TriMaximize","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients will only be included in the Non-Interventional Trial if Trimbow has been\r\n        prescribed in line with its current marketing authorisation and the guidance specified in\r\n        the summary of product characteristics (SmPC).\r\n\r\n        Physicians are urged to offer enrolment to all of their eligible patients consecutively as\r\n        they present for their routine visit, and not select patients from their patient database.\r\n\r\n        Eligible patients may only be included in the NIT after providing written (witnessed, where\r\n        required by law or regulation), IEC-approved informed consent.","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patients  18 years of age,\r\n\r\n          2. Patients with confirmed leading diagnosis of asthma with or without concomitant COPD,\r\n\r\n          3. Physician decision to start fixed triple therapy with ICS/LABA/LAMA (Trimbow MS or HS)\r\n             according to its current authorised indication. The treatment decision must be made\r\n             independently from participation in this NIS,\r\n\r\n          4. Patients willing and able to sign an informed consent for use of their pseudonymised\r\n             clinical data within the present non-interventional study.\r\n\r\n        Exclusion Criteria:\r\n\r\n        1) Participation in an interventional clinical trial within 30 days prior to enrolment into\r\n        the present non-interventional study or planned enrolment in an interventional clinical\r\n        trial during the observational period.\r\n      ","sponsor":"Chiesi UK","sponsor_type":"Industry","conditions":"Asthma","interventions":[{"intervention_type":"Other","name":"Other: Non-interventional","description":"As this is a non-interventional trial, only data obtained within the current routine management of asthma at outpatient respiratory centres or GP centres will be documented."}],"outcomes":[{"outcome_type":"primary","measure":"To describe patient characteristics and therapy pathways for patients with a diagnosis of moderate to severe asthma who are treated with Trimbow in real world practice","time_frame":"12 months","description":"Descriptive analysis of patient demographics"},{"outcome_type":"secondary","measure":"Assess asthma control (ACT)","time_frame":"12 months","description":"Change from baseline in ACT scores"},{"outcome_type":"secondary","measure":"Assess quality of life","time_frame":"12 months","description":"Change from baseline in Mini-AQLQ scores"},{"outcome_type":"secondary","measure":"Assess treatment adherence","time_frame":"12 months","description":"Change from baseline in TAI scores"},{"outcome_type":"secondary","measure":"Analyse parameters of lung function using spirometry","time_frame":"12 months","description":"Change from baseline in FEV1"},{"outcome_type":"secondary","measure":"Analyse parameters of small airways disease","time_frame":"12 months","description":"Change from baseline in small airway function measured by pre-dose AUCAX (Area under the curve of reactance) using available oscillometry system"},{"outcome_type":"secondary","measure":"Analyse parameters of asthma-related airway inflammation","time_frame":"12 months","description":"Change from baseline in percentage of patients with a fraction of exhaled nitric oxide (FeNO) below or above 20 ppb"},{"outcome_type":"secondary","measure":"Analyse parameters of persistent airflow limitation","time_frame":"12 months","description":"Change from baseline in percentage of patients with persistent airflow limitation (PAL); PAL defined as post-BD FEV1 <80% predicted and post-BD FEV1/FVC Ratio < 0.7"},{"outcome_type":"secondary","measure":"Analyse the incidence of asthma exacerbations","time_frame":"12 months","description":"Number of exacerbations 12 months prior to baseline and during study"},{"outcome_type":"secondary","measure":"Analyse the severity of asthma exacerbations as defined by the American Thoracic Society/European Respiratory Society (ATS/ERS) classification of asthma exacerbations","time_frame":"12 months","description":"Severity of exacerbations, defined according to the ATS/ERS classification of asthma exacerbations, will be analysed 12 months prior to baseline and during study"},{"outcome_type":"secondary","measure":"Analyse use of rescue medication","time_frame":"12 months","description":"Use of any rescue medication 7 days prior to baseline and during study 7 days prior to respective visit"},{"outcome_type":"secondary","measure":"Analyse use of systemic corticosteroids","time_frame":"12 months","description":"Use of any systemic corticosteroids 12 months prior to baseline and during study"},{"outcome_type":"secondary","measure":"Assess adverse events associated with use of Trimbow","time_frame":"12 months","description":"Assessment of the number and type of adverse events"},{"outcome_type":"secondary","measure":"Assess retention rate with Trimbow","time_frame":"12 months","description":"Assess continuation of treatment with Trimbow (retention rate of Trimbow) at month 12"}]}
{"nct_id":"NCT04925284","start_date":"2021-06-07","phase":"Phase 1","enrollment":199,"brief_title":"Study of XB002 in Subjects With Solid Tumors","official_title":"A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XB002 in Subjects With Inoperable Locally Advanced or Metastatic Solid Tumors","primary_completion_date":"2024-06-07","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2024-10-07","last_update":"2021-09-05","description":"This is a Phase 1, non-randomized, open-label, multicenter, dose-escalation and expansion study evaluating the safety, tolerability, PK, pharmacodynamics, and clinical antitumor activity of XB002 administered IV q3w as a monotherapy to subjects with advanced solid tumors.","other_id":"XB002-101","allocation":"Non-Randomized","intervention_model":"Sequential Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Dose-escalation followed by cohort-expansion in tumor-specific expansion cohorts","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Cytologically or histologically and radiologically confirmed solid tumor that is\r\n             inoperable, locally advanced, metastatic, or recurrent.\r\n\r\n          -  Dose-Escalation Stage Cohort A and Cohort-Expansion Stage (Cohorts B - G): The subject\r\n             has received standard life-prolonging therapies unless they do not exist, or available\r\n             therapies are intolerable or no longer effective.\r\n\r\n          -  Cohort-Expansion Stage Cohort B (Non-small Cell Lung Cancer): Subjects with Stage IV\r\n             NSCLC who have documented radiographic disease progression during or following their\r\n             last systemic anticancer therapy.\r\n\r\n          -  Cohort-Expansion Stage Cohort C (Urothelial Cancer): Subjects with transitional cell\r\n             histology (including renal pelvis, ureter, urinary bladder, urethra) who have\r\n             documented radiographic disease progression during or following their last systemic\r\n             anticancer therapy.\r\n\r\n          -  Cohort-Expansion Stage Cohort D (Epithelial Ovarian Cancer): Subjects with epithelial\r\n             ovarian cancer, including primary peritoneal cancer (PPC) and fallopian tube cancer\r\n             (FTC) who have platinum-resistant disease following treatment with platinum-containing\r\n             chemotherapy. Note: Ovarian borderline epithelial tumors (low malignant potential) are\r\n             not eligible.\r\n\r\n          -  Cohort-Expansion Stage Cohort E (Cervical Cancer): Subjects with carcinoma of the\r\n             uterine cervix who have documented radiographic disease progression during or\r\n             following their last systemic anticancer therapy.\r\n\r\n          -  Cohort F (SCCHN): Subjects with head and neck cancer (squamous cell histology) who\r\n             have documented radiographic disease progression during or following their last\r\n             systemic anticancer therapy. Allowed primary tumor locations are oral cavity,\r\n             oropharynx, hypopharynx, glottic larynx. Note: Excluded are subjects with primary\r\n             tumor site of the nasopharynx.\r\n\r\n          -  Cohort G (Pancreatic Cancer): Subjects with pancreatic cancer (adenocarcinoma\r\n             histology) who have documented radiographic disease progression during or following\r\n             their last systemic anticancer therapy.\r\n\r\n          -  Expansion Cohorts: Subjects must have measurable disease per RECIST 1.1 as determined\r\n             by the Investigator.\r\n\r\n          -  Tumor tissue material collected approximately 2 years prior to consent. If archival\r\n             tumor tissue is not available, a fresh tumor biopsy may be collected from subjects\r\n             enrolled in the Dose-Escalation Stage and must be collected from subjects in the\r\n             Cohort-Expansion Stage, at least 7 days (and up to 60 days) prior to first dose.\r\n\r\n          -  Recovery to baseline or  Grade 1 severity (Common Terminology Criteria for Adverse\r\n             Events version 5 [CTCAE v5]) from AEs.\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.\r\n\r\n          -  Adequate organ and marrow function.\r\n\r\n          -  Sexually active fertile subjects and their partners must agree to use medically\r\n             accepted methods of contraception.\r\n\r\n          -  Female subjects of childbearing potential must not be pregnant at screening.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Receipt of prior therapies as defined in study protocol\r\n\r\n          -  Known brain metastases or cranial epidural disease unless adequately treated with\r\n             radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks\r\n             before first dose of study treatment.\r\n\r\n          -  Uncontrolled, significant intercurrent or recent illness.\r\n\r\n          -  Corrected QT interval calculated by the Fridericia formula (QTcF) > 480 ms per\r\n             electrocardiogram (ECG).\r\n\r\n          -  Pregnant or lactating females\r\n\r\n          -  Diagnosis of another malignancy within 2 years before first dose of study treatment,\r\n             except for superficial skin cancers, or localized, low grade tumors deemed cured and\r\n             not treated with systemic therapy.\r\n      ","sponsor":"Exelixis","sponsor_type":"Industry","conditions":"Non Small Cell Lung Cancer|Urothelial Cancer|Epithelial Ovarian Cancer|Cervical Cancer|SCCHN|Pancreatic Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: XB002","description":"IV administration of XB002"}],"outcomes":[{"outcome_type":"primary","measure":"Cohort-Expansion Stage: Objective Response Rate (ORR)","time_frame":"12 months","description":"To evaluate preliminary efficacy of XB002 by estimating the ORR per RECIST 1.1 as assessed by the Investigator"},{"outcome_type":"secondary","measure":"Safety of XB002: Adverse Events","time_frame":"30 months","description":"To evaluate the safety of XB002 through the evaluation of incidence and severity of nonserious adverse events (AEs) and serious adverse events (SAEs)"},{"outcome_type":"secondary","measure":"Tolerability of XB002 as evaluated by the duration of exposure for the study","time_frame":"30 months","description":"To evaluate the tolerability of XB002 through the evaluation of duration of exposure for the study treatment"},{"outcome_type":"primary","measure":"Dose-Escalation Stage: MTD/recommended dose for XB002","time_frame":"18 months","description":"To determine the MTD and/or RD for further evaluation of IV administration of XB002 in subjects with advanced malignancies"},{"outcome_type":"secondary","measure":"Tolerability of XB002 as evaluated dose intensity of the study treatment","time_frame":"30 months","description":"To evaluate the tolerability of XB002 through the evaluation of dose intensity of the study treatment"},{"outcome_type":"secondary","measure":"Maximum Plasma Concentration (Cmax)","time_frame":"30 months","description":"To evaluate the Cmax for XB002, total antibody, and free payload at scheduled visits over time"},{"outcome_type":"secondary","measure":"Trough Concentration (Ctrough)","time_frame":"30 months","description":"To evaluate the Ctrough of XB002, total antibody, and free payload at scheduled visits over time"},{"outcome_type":"secondary","measure":"Immunogenicity of XB002","time_frame":"30 months","description":"To assess the immunogenicity of XB002 as measured by anti-drug antibody (ADA) analysis"},{"outcome_type":"secondary","measure":"Dose-Escalation Stage: Anti-tumor activity of XB002: Objective Response Rate (ORR)","time_frame":"30 months","description":"To evaluate the anti-tumor activity of XB002, as measured by ORR, per RECIST 1.1 as assessed by the Investigator"},{"outcome_type":"secondary","measure":"Anti-tumor activity of XB002: Duration of Response (DOR)","time_frame":"30 months","description":"To evaluate the anti-tumor activity of XB002, as measured by DOR, per RECIST 1.1 as assessed by the Investigator (dose escalation stage) or by a BIRC for selected cohorts (cohort expansion stage)"},{"outcome_type":"secondary","measure":"Anti-tumor activity of XB002: Progression Free Survival (PFS)","time_frame":"30 months","description":"To evaluate the anti-tumor activity of XB002, as measured by PFS, per RECIST 1.1 as assessed by the Investigator (dose escalation stage) or by a BIRC for selected cohorts (cohort expansion stage)"},{"outcome_type":"secondary","measure":"Cohort-Expansion Stage: overall survival","time_frame":"12 months","description":"To evaluate overall survival"}]}
{"nct_id":"NCT04887298","start_date":"2021-06-05","phase":"Phase 1/Phase 2","enrollment":55,"brief_title":"Study of Liposomal Annamycin for the Treatment of Subjects With Soft-Tissue Sarcomas (STS) With Pulmonary Metastases","official_title":"Phase 1B/2 Study Of Liposomal Annamycin (L-Annamycin) In Subjects With Previously Treated Soft-Tissue Sarcomas With Pulmonary Metastases","primary_completion_date":"2023-01-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2024-05-31","last_update":"2021-09-22","description":"This is a multi-center, open-label, single-arm study that in Phase 1b will determine the maximum tolerated dose (MTD)/ recommended phase 2 dose (RP2D) and safety of L-Annamycin and in Phase 2 will explore the efficacy of L- Annamycin as a single agent for the treatment of subjects with STS with lung metastases for which chemotherapy is considered appropriate.","other_id":"MB-107","allocation":"N/A","intervention_model":"Sequential Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. The subject has a pathologically confirmed diagnosis of STS and documented lung\r\n             metastases that are considered eligible for chemotherapy and not eligible for\r\n             potentially curative surgical resection of pulmonary-only metastatic disease.\r\n\r\n          2. The subject had prior anthracycline therapy (cumulative dose of 450 mg/m2) for their\r\n             disease and has shown progression of disease prior to study entry.\r\n\r\n          3. The subject must have measurable disease in the lung, defined as at a minimum, 1\r\n             lesion that can be accurately measured in at least one dimension of >10 mm. Subjects\r\n             with extra-pulmonary disease are eligible.\r\n\r\n          4. The subject has an estimated life expectancy of greater than 3 months.\r\n\r\n          5. The subject has an Eastern Cooperative Oncology Group (ECOG) performance status 2.\r\n\r\n          6. The subject is 18 years old at the time of signing informed consent.\r\n\r\n          7. At least 2 weeks must have passed following treatment for their disease with\r\n             chemotherapy, investigational therapy, targeted agents, biological agents, immune\r\n             modulators, or radiotherapy, and any toxicities must have resolved to  grade 1 or\r\n             previous baseline levels no more than 4 weeks after completing therapy (except\r\n             alopecia and polyneuropathy).\r\n\r\n          8. The subject must have adequate laboratory results including the following:\r\n\r\n               1. Absolute neutrophil count  1500/mL and platelets 100,000/mL\r\n\r\n               2. Hemoglobin  8.0 g/dL\r\n\r\n               3. Adequate renal function (The Cockcroft-Gault equation will be used to estimate\r\n                  creatinine clearance. This equation is as follows: Creatinine clearance in\r\n                  milliliters per minute = [140-age] x body weight [kg]/72 x plasma creatinine\r\n                  [mg/dL]; multiplied by 0.85 for women. By using this equation, adequate renal\r\n                  function will be deemed to be a creatinine clearance of greater than 60\r\n                  mL/minute)\r\n\r\n               4. Bilirubin 1.5 x upper limit of normal (ULN) (unless due to Gilbert's syndrome)\r\n\r\n               5. Aspartate aminotransferase (serum glutamic oxaloacetic transaminase) and/or\r\n                  alanine aminotransferase (serum glutamic pyruvic transaminase)  2.5  ULN ( 5 x\r\n                  ULN in subjects with liver metastases)\r\n\r\n          9. The subject is able to understand and sign the informed consent document, can\r\n             communicate with the Investigator, and can understand and comply with the requirements\r\n             of the protocol.\r\n\r\n         10. All subjects (men and women) agree to practice effective contraception during the\r\n             entire study period and after discontinuing study drug, unless documentation of\r\n             infertility exists.\r\n\r\n               1. Sexually active, fertile women must use 2 effective forms of contraception\r\n                  (abstinence, intrauterine device, oral contraceptive, or double barrier device)\r\n                  from the time of informed consent and until at least 6 months after discontinuing\r\n                  study drug\r\n\r\n               2. Sexually active men and their sexual partners must use effective contraceptive\r\n                  methods from the time of informed consent until at least 6 months after\r\n                  discontinuing study drug\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. The subject has any condition that, in the opinion of the Investigator, places the\r\n             subject at unacceptable risk if they were to participate in the study.\r\n\r\n          2. The subject has left ventricular ejection fraction (LVEF) <50%, valvular heart\r\n             disease, or severe hypertension not controlled by medical therapy. Cardiac subjects\r\n             with a New York Heart Association classification of 3 or 4 will be excluded, as will\r\n             those with recent ( 6 months) myocardial infarction, unstable angina, or symptomatic\r\n             congestive heart failure.\r\n\r\n          3. The subject has a baseline QT/QTc interval >480 msec, a history of additional risk\r\n             factors for torsade des pointes (e.g., heart failure, hypokalemia, family history of\r\n             Long QT Syndrome) and use of concomitant medications that significantly prolong the\r\n             QT/QTc interval.\r\n\r\n          4. The subject has clinically relevant serious comorbid medical conditions including, but\r\n             not limited to active infection, known positive status for human immunodeficiency\r\n             virus or active hepatitis B or C, cirrhosis, or psychiatric illness/social situations\r\n             that would limit compliance with study requirements.\r\n\r\n          5. The subject is pregnant, lactating, or not using adequate contraception.\r\n\r\n          6. The subject has a known allergy to study drug or excipients.\r\n\r\n          7. The subject is required to use moderate or strong inhibitors and inducers of\r\n             Cytochrome P450 family enzymes CYP3A and CYP2B and transporters that cannot be held 3\r\n             days before treatment and on the day of treatment.\r\n      ","sponsor":"Moleculin Biotech, Inc.","sponsor_type":"Industry","conditions":"Pulmonary Metastasis|Sarcoma,Soft Tissue","interventions":[{"intervention_type":"Drug","name":"Drug: Liposomal Annamycin (L-Annamycin)","description":"2-hour intravenous (IV) infusion of L-Annamycin on Day 1 followed by 20 days off of study drug (i.e., 1 treatment cycle= 21 days)"}],"outcomes":[{"outcome_type":"primary","measure":"Dose Limiting Toxicity","time_frame":"21 days","description":"Number of patients with a dose limiting toxicity (DLT) at each dose evaluated"},{"outcome_type":"secondary","measure":"Efficacy of L-Annamycin","time_frame":"At the end of every other treatment cycle ( each cycle is 21 days)","description":"Determine preliminary efficacy of L-Annamycin as per revised Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1)"},{"outcome_type":"secondary","measure":"Area Under the Plasma Concentration Versus Time Curve (AUC) of L-Annamycin","time_frame":"Cycle 1 Day 1 ( each cycle is 21 days)","description":"Determine pharmacokinetics of L-Annamycin and its metabolite, annamycinol as measured by AUC"}]}
{"nct_id":"NCT04839757","start_date":"2021-06-03","enrollment":1400,"brief_title":"Dengue Vaccine Strategy in Children Aged 9 to 17 Years in the French Caribbean","official_title":"Preparing for the Use of a Dengue Vaccine in the French Caribbean Islands of Martinique and Guadeloupe : the DengueSEA Study","primary_completion_date":"2021-12-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2022-02-28","last_update":"2021-06-24","description":"Dengue fever, an arbovirus transmitted by the Aedes mosquito, is a public health problem in all tropical and subtropical regions of the world. There is currently no antiviral treatment and vector control has shown its limits. The 2018 European marketing authorization of the tetravalent chimeric yellow fever / dengue vaccine (Dengvaxia) is a major step forward in the fight against the disease. Dengvaxia is indicated for the prevention of dengue due to serotypes DENV 1-4 in subjects aged 9 to 45 years with a history of infection with the dengue virus and living in endemic areas (seroprevalence of at least 70% in the target population). Dengue seroprevalence data in the French Caribbean territories of Martinique and Guadeloupe dates back to 2011 and concerns only adult blood donors aged 18 to 70 years. To date, no data exists for individuals aged 9 to 17 years in the region. In order to implement an optimal vaccine introduction strategy for these territories, the main aim of the DengueSEA study is to estimate the seroprevalence of the Dengue viruses (DENV 1-4) in 9-17 year olds giving a blood sample as part of care in hospital departments of the French Caribbean islands of Martinique and Guadeloupe.","other_id":"19_RIPH3_19","observational_model":"Cohort","time_perspective":"Cross-Sectional","sampling_method":"Probability Sample","gender":"All","minimum_age":9,"maximum_age":17,"population":"Any child aged 9 to 17 years presenting to one of the hospital departments participating in\r\n        the study at the University Hospitals of Martinique or Guadeloupe who Need to take a blood\r\n        sample or place a peripheral venous line for the management of the child\r\n\r\n        Collection of the parent's or legal guardian's non-objection to participate in the\r\n        Dengvaxia vaccine acceptability survey","criteria":"\n        CHILDREN\r\n\r\n        Inclusion Criteria for children:\r\n\r\n          -  Any child aged 9 to 17 years presenting to one of the hospital departments\r\n             participating in the study at the University Hospitals of Martinique or Guadeloupe\r\n\r\n          -  Need to take a blood sample or place a peripheral venous line for the management of\r\n             the child\r\n\r\n          -  Residence in Martinique or Guadeloupe since at least one year\r\n\r\n          -  Information on the study given to the child and his/her parent or legal guardian\r\n\r\n          -  Collection of the parent's or legal guardian's non-objection to the child's\r\n             participation\r\n\r\n        Exclusion Criteria for children:\r\n\r\n          -  Presence of fever or suspected acute infection\r\n\r\n          -  Presence of an immune deficiency or any other dysimmune condition\r\n\r\n        PARENTS\r\n\r\n        Parental inclusion criteria (\"vaccine acceptability\" survey)\r\n\r\n          -  Collection of the parent's or legal guardian's non-objection to participate in the\r\n             Dengvaxia vaccine acceptability survey\r\n\r\n          -  Comprehension of spoken and written French\r\n\r\n        Non-inclusion criteria for parents (vaccine acceptability survey)\r\n\r\n        - None of the above\r\n      ","sponsor":"University Hospital Center of Martinique","sponsor_type":"Other","conditions":"Dengue|Vaccination|Seroprevalence|Infectious Disease","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Dengue seroprevalence in the study population","time_frame":"through study completion, an average of 1 year","description":"Number of anti-DENV IgG positive cases, with seroneutralization in favor of previous DENV infection, divided by the total number of 9-17 year odl children/adolescents included in the DengueSEA study"},{"outcome_type":"secondary","measure":"Frequency of primary dengue fever","time_frame":"through study completion, an average of 1 year","description":"Serum neutralisation with antibody titration by DENV serotype (DENV 1 to 4)"},{"outcome_type":"secondary","measure":"Temporal variation of the risk of dengue infection","time_frame":"through study completion, an average of 1 year","description":"Implementation of a mathematical prediction model, based on a dynamic mode of infection during dengue epidemics in the French Caribbean, and taking into account dengue seroprevalence and surveillance data in the region since 2001 (Public Health France, sentinel physicians network)"},{"outcome_type":"secondary","measure":"Seroprevalence of Zika infection","time_frame":"through study completion, an average of 1 year","description":"anti-ZIKV IgG positivity and seroneutralization in favor of a previous Zika virus infection divided by the total number of children included in the DengueSEA study"},{"outcome_type":"secondary","measure":"Assessment of Dengvaxia® vaccine acceptability/characterization of intentions and attitudes","time_frame":"through study completion, an average of 1 year","description":"Questionnaire developed using the \"3C\" model developed by the WHO SAGE group to predict the degree of vaccine hesitancy, i.e., the refusal or postponement of certain vaccinations despite the availability of these products. The factors favored by this model are confidence in the safety of the vaccine (Confidence), perception of the importance of the targeted vaccination (Complacency), and perceived difficulties in obtaining this vaccination (Convenience)."}]}
{"nct_id":"NCT04793880","start_date":"2021-06-01","phase":"N/A","enrollment":240,"brief_title":"Cost and Shared Decision-Making for Heart Failure","official_title":"Integrating Cost Into Shared Decision-Making for Heart Failure With Reduced Ejection Fraction","primary_completion_date":"2023-03-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-03-31","last_update":"2021-06-11","description":"This study is designed to understand the impact of providing patient-specific cost at the time of the clinical encounter on decision-making for heart failure medications. The researchers will provide patients with heart failure with patient-specific cost information for non-generic heart failure medications. This cost information will be populated onto a checklist of recommended HF medications so that patients and their clinicians will have this information available during their clinical encounter. Patients in the control arm will receive the same checklist but without the cost information.","other_id":"STUDY00002215","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"None (Open Label)","intervention_model_description":"This study utilizes a stepped wedge cluster-randomized design where study sites are assigned to transition to the intervention as recruitment milestone are met.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosis of HFrEF (ejection fraction < 40%)\r\n\r\n          -  Outpatient clinical encounter with cardiologist (virtual or in-person)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Advanced HF therapy (LVAD or transplant or undergoing active workup or listing for\r\n             these therapies; home inotrope usage)\r\n\r\n          -  Patient currently in hospice care or with known life expectancy under 1 year\r\n\r\n          -  Dialysis-dependence or glomerular filtration rate (GFR) < 30 (due to medication\r\n             contraindications)\r\n\r\n          -  Pregnancy (because many guideline-recommended drugs, including those with associated\r\n             high costs, are not approved for use in pregnancy)\r\n\r\n          -  Non-English speaking (because of the absence of non-English speaking research staff to\r\n             communicate with non-English speaking patients and to qualitatively analyze/code\r\n             audio-recorded data)\r\n      ","sponsor":"Emory University","sponsor_type":"Other","conditions":"Chronic Heart Failure","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Medication Cost Information","description":"This version of the HFrEF medication checklist includes patient-specific estimated monthly out-of-pocket cost for each medication. TailorMed, a company designed to provide financial counseling and planning for patients, will generate the patients' out-of-pocket cost based on insurance status. The costs for non-generic HFrEF medications will then be populated onto a checklist of recommended heart failure medications so that patients and their clinicians will have this information available during their clinical encounter."},{"intervention_type":"Behavioral","name":"Behavioral: Heart Failure Medicines Checklist","description":"The Heart Failure Medicines Checklist is an evidence-based medication checklist that describes guideline-recommended medications for HFrEF. This tool is used during the clinical encounter to facilitate a discussion about medications that may be most appropriate for the patient."}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of Participants who Discussed Medication Cost","time_frame":"Day 1 (during clinic encounter)","description":"The percentage of patients whose clinic encounters involved a discussion of medication cost will be compared between study arms. The discussion of medication cost is a binary outcome of whether or not the cost of medication was discussed during the recorded clinical encounter. Any mention of medication cost will be counted as a cost discussion."},{"outcome_type":"secondary","measure":"Physician Recommendation Coding System (PhyReCS) Score","time_frame":"Day 1 (during clinic encounter)","description":"The strength of the clinical recommendation for a medication will be assessed with the Physician Recommendation Coding System (PhyReCS) scale, using the audio recording of the clinic encounter. The PhyReCS is a 5-point scale indicating how strongly the physician recommended a particular treatment. A strong recommendation is coded as +2, a mild recommendation is +1, recommendations neither for nor against treatment are coded as 0, a mild recommendation against treatment is -1, and a strong recommendation against treatment is coded as -2."},{"outcome_type":"secondary","measure":"Length of discussion","time_frame":"Day 1 (during clinic encounter)","description":"The length of medication cost discussion will be measured in minutes, using the audio recording of the clinic encounter."},{"outcome_type":"secondary","measure":"Helpfulness of medication checklist score","time_frame":"2 to 3 weeks after clinic encounter","description":"Participants will rate how helpful they found the medication checklist to be on a 5-point scale where 1 = extremely helpful and 5 = not helpful at all."},{"outcome_type":"secondary","measure":"Helpfulness of medication checklist with price information score","time_frame":"2 to 3 weeks after clinic encounter","description":"Participants in the intervention arm will rate how helpful they found the price information included on the medication checklist to be on a 5-point scale where 1 = extremely helpful and 5 = not helpful at all."},{"outcome_type":"secondary","measure":"Low Literacy Decisional Conflict Scale score","time_frame":"2 to 3 weeks after clinic encounter","description":"Participant perception of the visit with their doctor will be assessed with the Low Literacy Decisional Conflict Scale (DCS). The DCS includes 10 questions which are responded to as yes (scored as 0), no (scored as 4), or unsure (scored as 2). Total scores range from 0 to 40 with low scores indicating less difficulty in understanding treatment options."},{"outcome_type":"secondary","measure":"Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Clinician & Group Survey score","time_frame":"2 to 3 weeks after clinic encounter","description":"To assess participant perceptions of their doctor, questions 14-18 of the CAHPS Clinician & Group Survey - Adult Visit 4.0 (beta) instrument will be used. Responses are given on a 3-point scale where 1 = yes, definitely, 2 = yes, somewhat, and 3 = no. The total score of these 4 items range from 4 to 12 with lower scores indicating a more positive experience with their healthcare provider."},{"outcome_type":"secondary","measure":"Prescription of non-generic medications","time_frame":"Day 1 (during clinic encounter)","description":"The number of participants prescribed non-generic medications at the clinic encounter will be obtained from electronic medical records."},{"outcome_type":"secondary","measure":"Medication persistence","time_frame":"3 months after clinic encounter","description":"The number of participants continuing to take their prescribed medication three months after the clinic encounter will be obtained from electronic medical records."},{"outcome_type":"secondary","measure":"Clinician perceptions","time_frame":"End of study (up to 26 months)","description":"Clinician perceptions will be assessed qualitatively through focus group interviews."}]}
{"nct_id":"NCT04851652","start_date":"2021-06-01","enrollment":500,"brief_title":"Observational Study for Patients With Hypertrophic Cardiomyopathy","official_title":"Observational Study for Patients With Hypertrophic Cardiomyopathy","primary_completion_date":"2025-12-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2025-12-31","last_update":"2021-04-20","description":"Observational study on patients with hypertrophic cardiomyopathy aims to investigate the correlation between cardiac fibrosis, as indicated by cardiac magnetic resonance, and the prognosis, and further to explore biomarkers for cardiac fibrosis and adverse prognosis of hypertrophic cardiomyopathy. Therefore, endpoints including all-cause mortality, cardiovascular death, ventricular arrythmia, non-fatal stroke, non-fatal myocardial infarction, sudden death, successful cardiopulmonary resuscitation will be evaluated.","other_id":"GDREC2019545HR1","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","population":"Patients diagnosed with hypertrophic cardiomyopathy by medical history, physical\r\n        examination and echocardiography.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients diagnosed with hypertrophic cardiomyopathy by medical history, physical\r\n             examination and echocardiography.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with cardiac hypertrophy caused by other factors such as hypertension,\r\n             diabetes, myocardial amyloidosis, mitochondria cardiomyopathy, congenital heart\r\n             disease, valvular heart disease, etc; Patients who had underwent heart transplatation;\r\n             Individuals not suitable for the present study due to maligant tumor or severe trauma\r\n             will be excluded.\r\n      ","sponsor":"Guangdong Provincial People's Hospital","sponsor_type":"Other","conditions":"HCM - Hypertrophic Cardiomyopathy","interventions":[{"intervention_type":"Other","name":"Other: No intervention nor exposure","description":"As an observational study, no intervention nor exposure is interested."}],"outcomes":[{"outcome_type":"primary","measure":"All-cause death","time_frame":"5 YEARS","description":"All-cause mortality refers to death from any causes."},{"outcome_type":"secondary","measure":"Cardiovascular death","time_frame":"5 YEARS","description":"Cardiovascular death include death caused by stroke, MI, HF, sudden death or any other death attributed to cardiovascular diseases."},{"outcome_type":"secondary","measure":"Ventricular tachycardia","time_frame":"5 YEARS.","description":"Ventricular tachycardia is an abnormally fast heart beat (with three or more consecutive heart beats at least 100 beats per minute) that originates from one of the ventricles in the heart (ICD-code I47.2)."},{"outcome_type":"secondary","measure":"Ventricular fibrillation and flutter","time_frame":"5 YEARS.","description":"Ventricular fibrillation (VF) is a very rapid (150-500 bpm) irregularly irregular disorganized ventricular rhythm of varying configuration; with time, the amplitude of the fibrillation wave becomes progressively smaller, particularly immediately before death. Ventricular flutter (VFL) is a very rapid (180-250 bpm) and regular ectopic ventricular rhythm with undulations of equal amplitude and usually rapidly degenerates to VF(ICD-code I49.0)."},{"outcome_type":"secondary","measure":"nonfatal stroke","time_frame":"5 YEARS.","description":"Stroke (ICD-Code I60, I61, I63, I64) is a focal neurological deficit with symptoms continuing for more than 24 hours or leading to death with no apparent cause other than vascular. Stroke as an endpoint in this study includes definite ischemic stroke, primary intracerebral hemorrhage and subarachnoid hemorrhage with evidence from CT or MRI scan within 14 days of onset or autopsy confirmation, and stroke of unknown type etiology when CT, MRI, or autopsy are not done and information is inadequate to diagnose the etiology definitely."},{"outcome_type":"secondary","measure":"nonfatal myocardial infarction","time_frame":"5 YEARS.","description":"Acute myocardial infarction (MI) (ICD-Code I21) is defined when any one of the following criteria occurs. (1) Detection of a rise and/or fall of cardiac biomarker values, with at least one value above the 99th percentile upper reference limit and with at least one of the following manifestations: symptoms of ischaemia that should have lasted for at least 30 minutes and should not have been responsive to sublingual administration of nitrates; new or presumed new significant ST-segment-T wave changes or new left bundle branch block (LBBB); development of pathological Q waves in the ECG; imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. (2) Identification of an intracoronary thrombus by angiography or autopsy. (3) Cardiac death with symptoms suggestive of myocardial ischaemia and presumed new ischaemic ECG changes or new LBBB, but death occurred before cardiac biomarkers were obtained, or before cardiac biomarker values would be increased."},{"outcome_type":"secondary","measure":"sudden death","time_frame":"5 YEARS.","description":"Sudden death (ICD-Code I46.1, R96) encompasses any death of unknown origin occurring instantly or within an estimated 24 hours after the onset of acute symptoms as well as unattended death for which no likely cause can be established by autopsy or recent medical history."},{"outcome_type":"secondary","measure":"Cardiac arrest with successful resuscitation","time_frame":"5 YEARS.","description":"ICD-Code I46.0"},{"outcome_type":"secondary","measure":"Hospitalization for heart failure","time_frame":"5 YEARS","description":"Congestive heart failure (HF) (ICD-Code I50) requires the presence of three conditions, namely symptoms, such as dyspnea, clinical signs, such as ankle edema or crepitations, and the necessity to initiate treatment with open-label diuretics, vasodilators or antihypertensive drugs. HF cases may also be adjudicated as chronic stable HF but this is not considered an outcome of the present study."}]}
{"nct_id":"NCT04812535","start_date":"2021-06-01","phase":"Phase 2","enrollment":70,"brief_title":"Non-comparative Study of IFX-1 Alone or IFX-1+Pembrolizumab in Patients With Locally Advanced or Metastatic cSCC.","official_title":"Open Label, Multicenter Phase II Study of the C5a Antibody IFX-1 Alone or IFX-1 + Pembrolizumab in Patients With PD-1 or PD-L1 Resistant/Refractory Locally Advanced or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC)","primary_completion_date":"2023-07-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2024-06-30","last_update":"2021-08-26","description":"This is an open-label, \"non comparative\", non-randomized, Phase II study. Patients will be enrolled in 2 treatment arms","other_id":"IFX-1 P2.8","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Arm A: IFX-1 monotherapy; Arm B: IFX-1 + in combination with approved dosing scheme of pembrolizumab","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  At least 18 years of age on day of signing informed consent\r\n\r\n          -  Patients with biopsy-proven, histologically or cytologically confirmed (a.) locally\r\n             advanced cSCC not amenable for curative treatment or (b.) metastatic cSCC. Patients\r\n             must have been treated with all approved therapies for (a.) inoperable locally\r\n             advanced cSCC contraindicated for radiation therapy or (b.) metastatic cSCC\r\n\r\n          -  Eastern Cooperative Oncology Group performance status (ECOG PS) status of 1\r\n\r\n          -  Patients must have progressed on treatment with an anti-PD-1/L1 monoclonal antibody\r\n             (mAb) administered either as monotherapy or in combination with other checkpoint\r\n             inhibitors or other therapies.\r\n\r\n          -  Patient provides written informed consent for the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with limited cSCC, who do not require systemic therapy\r\n\r\n          -  Has a diagnosis of immunodeficiency or autoimmune disease, or is receiving chronic\r\n             systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or\r\n             any other form of immunosuppressive therapy within 3 weeks prior the first dose of\r\n             study treatment\r\n\r\n          -  Has severe hypersensitivity (Grade 3) to pembrolizumab or IFX-1 and/or any of their\r\n             excipients or had a severe (Grade 3) infusion-related reaction to treatments with\r\n             other mAbs\r\n\r\n          -  Patients who have undergone major surgery <4 weeks prior to starting study treatment\r\n\r\n          -  Patients with known Grade 3 (per National Cancer Institute common terminology\r\n             criteria for adverse events [NCI CTCAE] v5.0 criteria) active systemic or cutaneous\r\n             viral, bacterial, or fungal infection\r\n\r\n          -  Has known active central nervous system metastases and/or carcinomatous meningitis.\r\n\r\n          -  Patients with a history of other malignancies during the past 5 years\r\n\r\n          -  Patients with congestive heart failure, Class III or IV, by New York Heart Association\r\n             criteria\r\n\r\n          -  Patients who are pregnant or breastfeeding or expecting to conceive or father children\r\n             within the projected duration of the study,\r\n      ","sponsor":"InflaRx GmbH","sponsor_type":"Industry","conditions":"SSC","interventions":[{"intervention_type":"Drug","name":"Drug: IFX-1","description":"IFX-1 Monotherapy"},{"intervention_type":"Drug","name":"Drug: IFX-1 + pembrolizumab combination therapy","description":"IFX-1 + pembrolizumab combination therapy"}],"outcomes":[{"outcome_type":"secondary","measure":"Response (CR/iCR/PR/iPR) and SD- Arm B","time_frame":"Up to 36 months","description":"Response (CR/iCR/PR/iPR) and SD duration"},{"outcome_type":"primary","measure":"ORR- Arm A","time_frame":"Up to 36 months","description":"Investigator assessed best overall response rate (ORR) for IFX-1, with response being defined as best response of CR/confirmed CR (iCR) or PR/confirmed PR (iPR) per modified RECIST v1.1/iRECIST"},{"outcome_type":"primary","measure":"DLT- Arm B","time_frame":"Cycle 1 Day - Cycle 1 Day 36","description":"Frequency of dose-limiting toxicities (DLTs) by dose cohort"},{"outcome_type":"primary","measure":"ORR- Arm B","time_frame":"Up to 36 months","description":"Investigator assessed best ORR for IFX-1 + pembrolizumab, with response being defined as best response of CR/confirmed CR (iCR) or PR/confirmed PR (iPR) per modified RECIST v1.1/iRECIST"},{"outcome_type":"primary","measure":"TEAEs- Arm B","time_frame":"Up to 36 months","description":"Frequency, severity, and investigational new drug (IND) attribution of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) according to Medical Dictionary for Regulatory Activities (MedDRA) coding (version valid at time of reporting) and the NCI CTCAE grading system (version 5.0, 27 November 2017)"},{"outcome_type":"secondary","measure":"Disease control rate - Arm A","time_frame":"Up to 36 months","description":"Disease control rate (CR/iCR+PR/iPR+SD)"},{"outcome_type":"secondary","measure":"Progression-free survival (PFS)- Arm A","time_frame":"Up to 36 months","description":"Progression free survival"},{"outcome_type":"secondary","measure":"Overall survival (OS)- Arm A","time_frame":"Up to 36 months","description":"Overall survival (OS)"},{"outcome_type":"secondary","measure":"TEAEs- Arm A","time_frame":"Up to 36 months","description":"Frequency, severity, and IND attribution of TEAEs and SAEs according to MedDRA coding (version valid at time of reporting) and the NCI CTCAE grading system v5.0"},{"outcome_type":"secondary","measure":"ADAs- Arm A","time_frame":"Up to 27 months","description":"Development of human antidrug antibodies (ADAs) against IFX-1"},{"outcome_type":"secondary","measure":"QoL- Arm A","time_frame":"Up to 36 months","description":"Changes in QoL as per the European Organisation for Research and Treatment of Cancer (EORTC)-QoL questionnaire (QLQ)-C30 total score"},{"outcome_type":"secondary","measure":"Disease control rate- Arm B","time_frame":"Up to 36 months","description":"Disease control rate (CR/iCR+PR/iPR+SD)"},{"outcome_type":"secondary","measure":"Progression free survival- Arm B","time_frame":"Up to 36 months","description":"Progression free survival-"},{"outcome_type":"secondary","measure":"Overall survival- Arm B","time_frame":"Up to 36 months","description":"Overall survival"},{"outcome_type":"secondary","measure":"QoL - Arm B","time_frame":"Up to 36 months","description":"Quality of Life"},{"outcome_type":"secondary","measure":"ADAs against IFX-1 - Arm B","time_frame":"Up to 36 months","description":"Development of human ADAs against IFX-1"}]}
{"nct_id":"NCT04889924","start_date":"2021-06-01","phase":"N/A","enrollment":1666,"brief_title":"ALND vs RDT in Positive Sentinel Node After Neoadjuvant Therapy","official_title":"Axillary Lymph Node Dissection Versus Axillary Radiotherapy in Patients With Positive Sentinel Node After Neoadjuvant Therapy: A Multicenter Randomized Phase III Study","primary_completion_date":"2022-06-30","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2026-06-30","last_update":"2021-05-20","description":"In the case of primary surgery, in patients with sentinel node involvement, it has already been shown that omitting axillary lymph node dissection (ALND), often combining axillary radiotherapy (RT), does not worsen the prognosis and does significantly reduce the appearance of lymphedema. However, patients who have received neoadjuvant systemic treatment cannot benefit from this option, even though in the majority of those who have responded well to treatment, a residual disease in the armpit is low, but there are no studies yet published that supports the possibility of not performing lymphadenectomy. The primary endpoint of this study is to assess whether the irradiation of the axilla concerning axillary lymph node dissection is not inferior in recurrences and overall survival, in patients with positive sentinel lymph node (SN) after neoadjuvant systemic treatment.","other_id":"PR148/21","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"A prospective, randomized, multicenter study.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  T1-T4b N0-1 at diagnosis and subsidiary of neoadjuvant treatment\r\n\r\n          -  Post-CT SLN with 2 macrometastasis\r\n\r\n          -  If N + pre-neoadjuvant treatment also include micrometastases\r\n\r\n          -  Post-CT axillary ultrasound, BEDI <4 in all visualized nodes\r\n\r\n          -  Complete at least 3 months of neoadjuvant chemotherapy and 6 months of endocrine\r\n             treatment.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Inflammatory carcinoma or cN2\r\n\r\n          -  ypN0\r\n\r\n          -  History of breast surgery for ipsilateral cancer\r\n\r\n          -  History of other cancer in the last 5 years, except squamous carcinoma of the skin\r\n      ","sponsor":"Hospital Universitari de Bellvitge","sponsor_type":"Other","conditions":"Breast Cancer|Axillary Adenopathy|Radiotherapy Side Effect|Therapy-Associated Cancer","interventions":[{"intervention_type":"Radiation","name":"Radiation: Axillary Radiotherapy","description":"Axillary radiotherapy without lymphadenectomy (level I and II) + level III and supraclavicular +/- internal mammary chain"},{"intervention_type":"Procedure","name":"Procedure: Lymphadenectomy","description":"Axillary Lymph node dissection"}],"outcomes":[{"outcome_type":"primary","measure":"Disease-free survival","time_frame":"From date of diagnosis until the date of first documented recurrence or death, wichever came first,assessed up to 5 years","description":"to assess whether the irradiation of the axilla concerning axillary lymph node dissection is not inferior in disease-free survival, in patients with positive sentinel lymph node (SN) after neoadjuvant systemic treatment."},{"outcome_type":"secondary","measure":"Overall survival","time_frame":"From date of diagnosis until the date of death from any cause, assessed up to 5 years","description":"to assess whether the irradiation of the axilla concerning axillary lymph node dissection is not inferior in overall survival, in patients with positive sentinel lymph node (SN) after neoadjuvant systemic treatment."},{"outcome_type":"secondary","measure":"Lymphedema Incidence","time_frame":"From date of surgery until the date of first lynphedema apparition, assessed up to 5 years","description":"Volume difference between both arms (cm^3) above 10%"}]}
{"nct_id":"NCT04814056","start_date":"2021-06-01","phase":"Phase 4","enrollment":15,"brief_title":"To Evaluate the Efficacy of Afatinib in the Treatment of Locally Advanced/Metastatic Non-Small Cell Lung Cancer With NRG1 Fusion","official_title":"An Open-Labeled, Single-Arm Clinical Study to Evaluate the Efficacy of Afatinib in Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer With NRG1-Fusion","primary_completion_date":"2023-09-29","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2024-01-31","last_update":"2021-04-01","description":"This is an open-label, sing-arm, phase IV clinical study. The study is designed to evaluate the efficacy of Afatinib in treatment of NRG1-fused locally advanced/metastatic non-small cell lung cancer (NSCLC), and explore the clinical factors that may predict the effectiveness of treatment.","other_id":"BI-IIT-AFATINIB-I","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  The patient or his/her legal representative has signed a written informed consent form\r\n             and dated it prior to any specific research procedure.\r\n\r\n          -  Aged 18 years or older.\r\n\r\n          -  Locally advanced or metastatic non-small cell lung cancer with NRG1 fusion detected by\r\n             DNA or RNA-based next-generation sequencing (NGS) technology in tumor tissue specimens\r\n             or liquid specimens.\r\n\r\n          -  The patient has received platinum-based doublet chemotherapy previously.\r\n\r\n          -  ECOG performance status score is 0~2.\r\n\r\n          -  The patient has sufficient bone marrow and organ functionality, which can be proved by\r\n             complete blood cell count, blood biochemistry and urine biochemistry tests at\r\n             baseline.\r\n\r\n          -  The patient has measurable lesion(s).\r\n\r\n          -  The female patient of childbearing age must adopt appropriate contraceptive measures\r\n             and are not allowed to breastfeed a child.\r\n\r\n          -  The male patient must voluntarily use contraceptives.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  The patient has shown any severe or uncontrollable systemic disease sign that the\r\n             investigators believe may significantly change the risk/benefit balance of the\r\n             patient, including uncontrollable hypertension, high active bleeding tendency, active\r\n             infection or significant damage of bone marrow or other functions.\r\n\r\n          -  The patient has previously been treated with EGFR-TKI or any monoclonal antibody that\r\n             acts on HER2/3.\r\n\r\n          -  The patient has been found with symptomatic metastatic tumor of central nervous system\r\n             (CNS).\r\n\r\n          -  The patient has a history of interstitial pneumonia or radiation pneumonia requiring\r\n             steroid therapy.\r\n\r\n          -  The patient has not recovered yet from toxic reactions with CTCAE grade 3 (CTCAE5.0)\r\n             caused by previous treatment.\r\n      ","sponsor":"Shanghai Chest Hospital","sponsor_type":"Other","conditions":"NRG1-fused Non-small Cell Lung Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Afatinib Dimaleate","description":"Afatinib is the second-generation TKI drug, which can irreversibly bind to receptors of erbB family. Afatinib will be administered orally at a dose of 40 mg per time, Q.D. If a patient cannot tolerate a dose of 40mg due to adverse reactions, when the adverse reactions restore to level 1 (CTCAE 5.0) or below, the dosage could be adjusted to 30mg per day, Q.D."}],"outcomes":[{"outcome_type":"primary","measure":"objective response rate (ORR)","time_frame":"Up to 12 months","description":"ORR"},{"outcome_type":"secondary","measure":"disease control rate (DCR)","time_frame":"Up to 12 months","description":"DCR"},{"outcome_type":"secondary","measure":"progression-free survival (PFS)","time_frame":"Up to 12 months","description":"PFS"}]}
{"nct_id":"NCT04973774","start_date":"2021-06-01","enrollment":600,"brief_title":"A Multi-center Prospective Study of Branch Atheromatous Disease in China","official_title":"A Multi-center Prospective Study of Branch Atheromatous Disease in China","primary_completion_date":"2023-05-31","study_type":"Observational [Patient Registry]","rec_status":"Recruiting","completion_date":"2025-06-01","last_update":"2021-08-04","description":"Branch atheromatous disease (BAD), is regarded as one of the important etiologies for acute isolated subcortical infarction, especially in Asian population. However, due to the fact that the existing imaging techniques cannot depict small vessel changes, the clinical diagnosis, therapy and research of BAD are facing challenges. We have started a multi-center prospective observational study of BAD in China, aiming at establishing a large-sample clinical-radiological cohort of BAD, analyzing predictors for functional outcome, and exploring the efficacy of tirofiban on BAD. A standardized Case Report Form (and eCRF on website) is used to collect baseline and follow-up information on epidemiological, clinical, radiologicalMRI, SWI, MRA, HRMRI,3TVWIand blood test. The primary outcome was mRS on 90 days with blind evaluation.","other_id":"BADstudy","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":80,"population":"Study population will include all acute ischemic stroke patients meeting the inclusion and\r\n        exclusion criteria in all centers of our study.","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age:18-80years\r\n\r\n          2. Acute cerebral infarction:if the clinical manifestations are TIA, new infarct lesions\r\n             should be found on DWI at the same time.\r\n\r\n          3. The time from onset to enrollment is less than 72 hours. If the onset time was\r\n             unknown, the time of last known free of new ischemic symptoms to enrollment is less\r\n             than 72h.\r\n\r\n          4. Meet the following radiological criterial 1) DWI infarct: single (isolated) deep\r\n             (subcortical) infarct. 2) The culprit vessels are the lenticulostriate artery or the\r\n             para-pontine median artery, and the infarct lesion on DWI conforms to one of the\r\n             following characteri stics(A/B): A. Lenticulostriate artery:  \"comma-like\" infarct\r\n             lesions with \"fan-shaped\" extension from bottom to top in the coronary position; OR \r\n             3 layers (layer thickness 5-7 mm) on axial DWI images of the head; B. Para-pontine\r\n             median artery: the infarct lesion extends from the deep pons to the ventral pons on\r\n             the axial DWI of the head.\r\n\r\n        3) No 50% stenosis on the parent artery of the criminal vessel (i.e. corresponding basilar\r\n        or middle cerebral artery) (confirmed by MRA or CTA or DSA).\r\n\r\n        5.Signed informed consent by the patient or legally authorised representatives\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Intracranial hemorrhagic diseases, vascular malformations, aneurysms, brain abscesses,\r\n             malignant space occupying lesions or other non-ischemic intracranial lesions observed\r\n             by baseline head CT and MRI, MRA/CTA/DSA;\r\n\r\n          2. There was 50% stenosis of extracranial vessels with ipsally serial relationship\r\n\r\n          3. Cardiogenic embolism: atrial fibrillation, myocardial infarction, valvular heart\r\n             disease, dilated cardiomyopathy, infective endocarditis, atrioventricular block\r\n             disease, heart rate less than 50 beats /min\r\n\r\n          4. Have received or plan to receive acute endovascular treatment after onset of the\r\n             disease\r\n\r\n          5. stroke caused by other clear causes, such as moyamoya disease, arterial dissection,\r\n             vasculitis, etc\r\n\r\n          6. mRS score prior to the onset of the disease was 2 points\r\n\r\n          7. Known malignant tumor\r\n\r\n          8. Life expectancy 6 months\r\n\r\n          9. Can not tolerate 3T MRI examination\r\n\r\n         10. Pregnant or lactating women\r\n\r\n         11. Participation in another clinical within 3 months before enrollment, or taking part in\r\n             another ongoing study.\r\n      ","sponsor":"Peking Union Medical College Hospital","sponsor_type":"Other","conditions":"Cerebral Infarction|Disease|Magnetic Resonance Imaging","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"modified ranking score","time_frame":"90 days","description":"modified ranking score on 90 days, range:0-6scores; higher score means worse outcome"}]}
{"nct_id":"NCT04859673","start_date":"2021-06-01","phase":"N/A","enrollment":30,"brief_title":"Influence of Radial Extracorpeal Shock Wave in Hemiplegic Shoulder Patients","official_title":"Influence of Radial Extracorpeal Shock Wave Therapy on Sonographic Findings in Patients With Hemiplegic Shoulder Pain","primary_completion_date":"2021-08-01","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2021-09-01","last_update":"2021-05-20","description":"The purposes of this study are to examine sonographic structural changes pre and post the radial extracorporeal shock wave intervention in hemiplegic shoulder pain, and to assess the relationships between sonographic structural changes and hemiplegic shoulder pain.","other_id":"P.T.REC/012/002870","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","intervention_model_description":"The selected patients will be randomly assigned to two equal groups (study group (GI), and control group (GII).The study group (GI) will be treated by the radial extracorporeal shock wave in addition to design physical therapy program.\r\n The control group (GII) will be treated by sham radial extracorporeal shock wave in addition to the same design physical therapy program of (GI).","sampling_method":"","gender":"All","minimum_age":30,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  1. Patient's age ranges from 40 to 60 years. 2. Spasticity of upper limb ranges from\r\n             mild to moderate (grade 1+: 2) according to modified aschworth scale (MAS).\r\n\r\n             3. Patients with sufficient cognitive abilities that enables them to understand and\r\n             follow instructions (Mini-Mental Scale >24).\r\n\r\n             4. Patient who understand the study process and signed the informed consent form.\r\n\r\n             5. Patient with stroke more than 3 months ago. 8. Patient with shoulder pain and\r\n             limited range of motion (ROM) or loss of motion in the proximal arm on the hemiplegic\r\n             side.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  The following patients will be excluded from the study:\r\n\r\n               1. Patients who cannot express their own pain intensity.\r\n\r\n               2. Patients with a history of trauma or surgery to the shoulder on the affected\r\n                  side.\r\n\r\n               3. Patients with history of oral NSAIDs 3 days before this study or take warfarin\r\n                  medication with an international normalized ratio above 4.0.\r\n\r\n               4. Patients with a history of shoulder pain before the stroke.\r\n\r\n             6. Patients who have received a previous shoulder intra-articular injection or other\r\n             interventions on the affected shoulder within one month before rESWT.\r\n\r\n             7. Patients with cardiac pacemaker. 8. Patients who have osteoporosis. 9. Patients\r\n             with psychological problems.\r\n      ","sponsor":"Delta University for Science and Technology","sponsor_type":"Other","conditions":"Hemiplegia|Spastic","interventions":[{"intervention_type":"Device","name":"Device: radial extracorpeal shock wave","description":"Swiss DolorClast Master - Shockwave Therapy System will be used to apply the radial extracorporeal shock wave. It consists of master console, Evo Blue hand-piece, 15mm and 36mm interchangeable contact heads (applicators), contact gel, cart, and external compressor"}],"outcomes":[{"outcome_type":"primary","measure":"Evaluation of hemiplegic shoulder structural changes by ultrasonography","time_frame":"Baseline","description":"Ultrasonography evaluation includes long head of biceps tendon ,subscapularis tendon, supraspinatus tendon, infraspinatus tendon. Each abnormal ultrasound (US) finding will be assigned a score of one (1) if present or zero (0) if absent. Long head of biceps effusion, sub acromial sub deltoid bursa effusion, subluxation, and adhesive capsulitis scored. Tendon tear, tendinosis, and tendon degeneration will be similarly scored for each of the four examined tendons per shoulder. The sum of these scores yielded a raw ultrasound (US) score; such that the minimum score was zero (normal examination) while the maximum score amounted to sixteen .The raw US scores will be further grouped into graded US scores, such that scores of 0, 1-2, 3-4, 5-6, and more than 6 abnormal sonographic findings represented normal shoulder, mild damage, moderate damage, severe damage, and intense damage, respectively"},{"outcome_type":"secondary","measure":"Pain assessment by using shoulder pain and disability index (SPADI).","time_frame":"Baseline","description":"Shoulder pain and disability index is a shoulder specific self-reported questionnaire measuring pain and disability in patients with shoulder pain. It contains 5 items assessing pain and 8 items assessing shoulder function. Each item is scored on visual analogue scale with (Right end) defined as \"worst pain imaginable/ so difficult required help\", (Left end)\"no pain/no difficulty\". Scores will be calculated as follow, in part one pain scores in all questions will be added, and the mean value will be chosen. In part two functional scores of all questions will add and the mean value will be chosen for the purpose of data analysis. Final score for each part will be statistically analyzed separately"}]}
{"nct_id":"NCT04838366","start_date":"2021-06-01","phase":"N/A","enrollment":66,"brief_title":"Effect of Preoperative Carbohydrate Loading in Femur Fracture","official_title":"The Effect of Pre-operative Carbohydrate Loading in Femur Fracture: A Randomized Controlled Trial","primary_completion_date":"2021-07-30","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2021-08-01","last_update":"2021-04-09","description":"Femur fracture is very common in older people. It makes the people bedridden for long time at hospital. The fracture of femur is generally managed by the surgical procedure. Prolonged fasting for surgery makes the patients harassed physically as well as mentally. The long fasting state emphasizes the body more in catabolic state which increases the insulin resistivity. Pre-operative carbohydrate loading before two hours the surgery has been launched in practice to overcome these problems in the world context, however it is not in existence in Nepal. The aim of the study is to evaluate the effect of pre-operative carbohydrate loading in the case of femur fracture surgery. This study utilize a hospital based randomized control trial study design to assess the effect of carbohydrate loading before two hours the surgery over the completely fasting state. A representative sample size of 66 patients (control group =33 and study group =33) aged 50 years and above having femur fracture planned for surgery will be selected for research. The pre-operative nutritional status will be identified and the post-operative outcomes will be measured by Visual Analogue Score (VAS) and Cumulative Ambulatory Score (CAS). Statistical analysis will be performed using chi square test, independent sample t-test or Mann-Whitney U test to compare between the outcome of study groups and control groups. The outcome of the study may provide a platform to the anaesthesiologists and surgeons towards the emerging concept of pre-operative carbohydrate loading practice in Orthopedics surgery in Nepal.","other_id":"Carbohydrateloading","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","intervention_model_description":"Participants will be randomized in a 1:1 ratio, and assigned into study group and control group randomly through computer generated block randomization.","sampling_method":"","gender":"All","minimum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -   Patients of age 50 years and above with femur fracture scheduled for surgery under\r\n             spinal anesthesia\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pre-existing diabetes (Type I or II)\r\n\r\n          -  Previous intolerance to carbohydrate drinks\r\n\r\n          -  Pathological fracture or any suspected pathology\r\n\r\n          -  Failure case of surgery or non-union case\r\n      ","sponsor":"Armed Police Force Hospital, Nepal","sponsor_type":"Other","conditions":"Femur Fracture","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Carbohydrate loading","description":"study group will be intervened with carbohydrate loading as the protocol made by ERAS(Li et al., 2021). Surgical patients will be asked to drink a beverage containing 100 grams carbohydrate the night before surgery. On the day of surgery, patients will drink a beverage containing 50 grams carbohydrate 2 hours before surgery under the supervision of research team member. We will provide glucose-D (Dabur Nepal Private Limited, Bara, Nepal, (Regd No.: 3506/045/046, DFTQC No.: 01-33-55-03-218)."}],"outcomes":[{"outcome_type":"primary","measure":"wellbeing of the patients","time_frame":"One week","description":"The visual analog scale (VAS) will be used to evaluate the well-being of the patients (pain, thirst, and hungry) after surgery. The VAS scores will be recorded on the morning of the first and second postoperative day (24, and 48 hours post-operative, respectively) for groups."},{"outcome_type":"primary","measure":"Functional mobility of the patients","time_frame":"One week","description":"The Cumulative Ambulatory Score (CAS) will be applied to find out the mobility function after surgery. The CAS scores will be recorded on the morning of the first, second, and third postoperative day (24, 48, and 72 hours post-operative, respectively) for both groups."},{"outcome_type":"secondary","measure":"Change serum albumin level","time_frame":"One week","description":"Serum albumin level will be assessed after surgery for both groups"}]}
{"nct_id":"NCT04860843","start_date":"2021-05-31","phase":"N/A","enrollment":30,"brief_title":"Nerve Blocks in Alloplastic Breast Reconstruction","official_title":"Regional Nerve Blocks in Alloplastic Breast Reconstructive Surgery: A Pilot, Randomized Controlled Trial","primary_completion_date":"2022-05-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-08-31","last_update":"2021-05-06","description":"Pain management is a major concern in oncologic breast surgery and reconstruction. Significant risks for acute and chronic pain after surgery might be reduced through improved pain control pre-operatively. Addition of regional anesthesia to a multimodal peri-operative pain management protocol offers a promising solution for improved recovery. For patients undergoing mastectomy with immediate alloplastic breast reconstruction, this RCT compares TPVB+Pecs II local anesthetic block with TPVB local anesthetic block and Pecs II placebo normal saline block for their effect on acute pain, chronic pain, opioid consumption, opioid-related side effects, patient-reported quality of recovery after surgery, and length of stay.","other_id":"H20-00787","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"Female","minimum_age":19,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patients must be female, and at least 19 years old.\r\n\r\n          2. Patients must be ASA grade I or II.\r\n\r\n          3. Patients must be undergoing total mastectomy with IBR using tissue expander or\r\n             implant, with or without axillary surgery.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients have a known contraindication for a regional block: known coagulation\r\n             disorder, treatment with anticoagulants, infection at the injection site, known\r\n             allergy to medication in the study.\r\n\r\n          2. Patients who are pregnant at the time of surgery.\r\n\r\n          3. Patients having bilateral mastectomy and immediate alloplastic breast reconstruction\r\n             (as only one side can be blocked to prevent local anesthesia toxicity).\r\n\r\n          4. Patients with ASA Class III or IV.\r\n\r\n          5. Patients with BMI>35kg/m2.\r\n\r\n          6. Patients weighing less than 50kg.\r\n\r\n          7. Patients living/staying outside of 1-hour driving distance from hospital.\r\n      ","sponsor":"University of British Columbia","sponsor_type":"Other","conditions":"Nerve Block|Surgery, Plastic|Mastectomy|Breast Reconstruction","interventions":[{"intervention_type":"Drug","name":"Drug: Thoracic paravertebral block","description":"Participants will receive a thoracic paravertebral with local anesthetic infiltrate (30ml of 0.35% ropivacaine with 1:400K epinephrine)."},{"intervention_type":"Drug","name":"Drug: Pecs II block","description":"Participants will receive a and a pecs II block with local anesthetic infiltrate (30ml of 0.25% ropivacaine with 1:400K epinephrine)."},{"intervention_type":"Drug","name":"Drug: Sham Pecs II block","description":"Participants will receive a and a pecs II block with saline infiltrate (30ml normal saline; 0.9% NaCl)."}],"outcomes":[{"outcome_type":"secondary","measure":"Number of participants with failure of early discharge.","time_frame":"Up to 48 hours post-operatively","description":"Failure of early discharge is defined as emergency room visits within 48 hours of discharge"},{"outcome_type":"primary","measure":"Rate of participant recruitment","time_frame":"1 year","description":"The definitive trial will be considered feasible if > 50% of eligible patients are enrolled in this pilot study."},{"outcome_type":"primary","measure":"Rate of successful nerve blocks","time_frame":"1 year","description":"The definitive trial will be considered feasible if > 90% of blocks are successful."},{"outcome_type":"primary","measure":"Rate of participant retention","time_frame":"6 months","description":"The definitive trial will be considered feasible if there is > 90% participant retention at 6 months."},{"outcome_type":"primary","measure":"Average pain score in the 24-hour post-operative period assessed by the Numerical Rating Scale.","time_frame":"24 hours post-operatively","description":"The Numerical Rating Scale is an 11-point scale (0-10), where a lower number indicates less pain. We will consider preliminary evidence of efficacy for a definitive trial if the 80% confidence interval for the between-group difference in average pain score in the 24-hour postoperative period favours LA block."},{"outcome_type":"secondary","measure":"Opioid analgesia requirements","time_frame":"24 hours post-operatively","description":"Will include intraoperative opioids administered in the OR and postoperative opioids administered/ingested in the Postanesthetic Care Unit (PACU), Surgical Day Care Unit (SDC), Inpatient Unit, and home in the 24-hour period after completion of surgery. Opioids consumed will be converted to MME."},{"outcome_type":"secondary","measure":"Acute patient-reported pain scores assessed by the Numerical Rating Scale","time_frame":"Up to 24 hours post-operatively","description":"The Numerical Rating Scale is an 11-point scale (0-10), where a lower number indicates less pain). It will be measured at the standard time points of nursing care assessments: preoperatively (baseline); four times per hour in PACU until discharge; if admitted, hourly for 2 hours, and then every 6 hours in the Inpatient Unit; and at discharge from hospital; 24 hours after surgery is complete."},{"outcome_type":"secondary","measure":"Post-operative nausea measured by the Numerical Rating Scale","time_frame":"24 hours post-operatively","description":"The Numerical Rating Scale is an 11-point scale (0-10), where a higher score indicates a better outcome/ less nausea."},{"outcome_type":"secondary","measure":"Post-operative vomiting measured by number of vomiting episodes","time_frame":"Up to 48 hours post-operatively","description":"Number of vomiting episodes in the post-anesthesia care unit and at home will be measured."},{"outcome_type":"secondary","measure":"Quality of Recovery Score measured by the Quality of Recovery 15 Questionnaire","time_frame":"Baseline (prior to surgery) and 24 hours after surgery","description":"The Quality of Recovery 15 (QoR-15) is a 15-item questionnaire that assesses patient-reported pain, physical comfort, physical independence, psychological support, and emotional state. Questions are rated in an 11-point scale (0-10), where a higher score indicates a better outcome. The QoR-15 takes an average of 2.5 minutes to complete. The QoR-15 has been statistically validated and is designed for both ambulatory and inpatient surgery populations. The QoR-15 will be completed at baseline prior to surgery and 24 hours after surgery."},{"outcome_type":"secondary","measure":"Length of stay in hospital in hours","time_frame":"Up to 96 hours post-operatively","description":"Measured from the time admitted to PACU to the time discharged from hospital. LOS includes time in the PACU, Surgical Day Care (SDC) and, if required, Inpatient Unit. Patients are transferred between units and discharged from hospital according to standardized institutional criteria"},{"outcome_type":"secondary","measure":"Time to perform ultrasound-guided TPVB+PecsII","time_frame":"Up to 24 hours post-operatively","description":"Measured in minutes."},{"outcome_type":"secondary","measure":"Time under general anesthesia","time_frame":"Up to 24 hours post-operatively","description":"Measured in minutes."},{"outcome_type":"secondary","measure":"Time in PACU","time_frame":"Up to 24 hours post-operatively","description":"Measured in minutes."},{"outcome_type":"secondary","measure":"Number of participants with failure of discharge from PACU and requiring admission to hospital","time_frame":"Up to 24 hours post-operatively","description":"Categorical."},{"outcome_type":"secondary","measure":"Number of participants requiring rescue opioid analgesics and anti-emetics.","time_frame":"Up to 7 days post-operatively","description":"Rescue medication are defined as those required \"as needed\" (ie. Beyond scheduled) in the PACU, ward and after discharge."},{"outcome_type":"secondary","measure":"Time to rescue opioid analgesics and anti-emetics.","time_frame":"Up to 7 days post-operatively","description":"Rescue medication are defined as those required \"as needed\" (ie. Beyond scheduled) in the PACU, ward and after discharge. Time to rescue medications is measured in minutes."},{"outcome_type":"secondary","measure":"Number of participants with complications and adverse events","time_frame":"Up to 24 hours post-operatively","description":"Related to the ultrasound-guided regional block: vascular or nerve injury, Horner's syndrome, bleeding/hematoma, local anesthetic systemic toxicity, pneumothorax, distortion tissue planes during axillary dissection, and other.\r\nRelated to the surgery: hematoma, tissue necrosis, urgent unplanned return to the operative theater within 24 hours of surgery."}]}
{"nct_id":"NCT04153955","start_date":"2021-05-31","phase":"Phase 3","enrollment":852,"brief_title":"Earlier Mobilization Post Acute Thrombectomy","official_title":"Earlier Mobilization Post Acute Thrombectomy","primary_completion_date":"2022-07-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2022-12-31","last_update":"2020-07-07","description":"This is a phase III trial trying to determine whether 12-hour bed rest following thrombectomy for ischemic stroke is non-inferior to 24-hour bed rest by measure of outcomes on the modified Rankin Scale (mRS) at 90 days post bed rest.","other_id":"H00018239","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age 18 years or older\r\n\r\n          -  Received thrombectomy (may have also received intravenous tPA) for a diagnosis of\r\n             acute ischemic stroke\r\n\r\n          -  TICI 2b/2c/3 score following thromectomy\r\n\r\n          -  Patient and/or Legally Authorized Representative provide consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  TICI 0/1/2a score following thrombectomy\r\n\r\n          -  Venous thromboembolism present at symptom onset\r\n\r\n          -  Pneumonia present at symptom onset\r\n\r\n          -  STEMI at symptom onset\r\n\r\n          -  Positive troponins at symptom onset according to local values\r\n\r\n          -  Bone fracture at symptom onset\r\n\r\n          -  Intubation anticipated or occurred\r\n\r\n          -  Symptomatic intracranial hemorrhage (defined as increase in NIHSS by 4 points or more\r\n             accompanied by PH2 hemorrhage on imaging) at the time of screening.\r\n\r\n          -  Pre-screening systolic blood pressure < 110 mmHg\r\n\r\n          -  Resting pulse oximetry < 92% (with or without supplemental oxygen)\r\n\r\n          -  Neurological worsening (defined as NIHSS increase of 4 points compared to initial\r\n             score) prior to screening.\r\n\r\n          -  Baseline modified Rankin Scale score > 2\r\n\r\n          -  Known Pregnancy\r\n\r\n          -  Patient not anticipated to survive 3 months\r\n\r\n          -  Patient not anticipated to follow-up at 3 months\r\n      ","sponsor":"Brian Silver","sponsor_type":"Other","conditions":"Stroke|Stroke, Acute|Stroke, Ischemic","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Mobilization","description":"Any movement out of bed"}],"outcomes":[{"outcome_type":"primary","measure":"90 Day Modified Rankin Scale (mRS) score","time_frame":"90 days post bed rest","description":"Proportion of patients with a modified Rankin Scale score (min 0, max 5 with 0 being the best outcome) of 0-2 at 90 days"},{"outcome_type":"secondary","measure":"Pneumonia","time_frame":"Duration of hospitalization stay, average 5 days","description":"Determine whether rates of pneumonia are at least similar in the two arms. Rates will be measured as percentages of the entire population at risk."},{"outcome_type":"secondary","measure":"Venous Thromboembolism","time_frame":"Duration of hospitalization stay, average 5 days","description":"Determine whether rates of Venous Thromboembolism (VTE) are at least similar in the two arms. Rates will be measured as percentages of the entire population at risk."},{"outcome_type":"secondary","measure":"Neurological Worsening","time_frame":"Duration of hospitalization stay, average 5 days","description":"Determine whether rates of neurological worsening are at least similar in the two arms. Rates will be measured as percentages of the entire population at risk."},{"outcome_type":"secondary","measure":"Readmission","time_frame":"90 days post bed rest","description":"Determine whether rates of readmission are at least similar in the two arms."},{"outcome_type":"secondary","measure":"Length of Stay","time_frame":"Duration of hospitalization stay, average 5 days","description":"Determine whether length of hospital stay are at least similar in the two arms. This will be measured in days."}]}
{"nct_id":"NCT04893304","start_date":"2021-05-30","phase":"N/A","enrollment":20,"brief_title":"Study of the Effect of Fractional co2 Laser Versus Q Switched:NdYAG Laser in the Treatment of Acanthosis Nigricans","official_title":"Study of the Effect of Fractional co2 Laser Versus Q Switched:NdYAG Laser in the Treatment of Acanthosis Nigricans","primary_completion_date":"2022-04-30","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2022-04-30","last_update":"2021-05-19","description":"This prospective randomized comparative split study will be conducted at the outpatient clinic, Dermatology department, Faculty of Medicine, Cairo University and will include 20 patients with acanthosis nigricans in otherwise healthy individuals which will be recruited and assessed for eligibility for inclusion according to the above criteria. -Evaluation: All patients will be subjected to: Pre-operative preparation: - Informed written consent will be taken from every patient prior to the study. - Detailed history taking including onset, course, duration of the disease and occupation (sun-exposed or not), predisposing factors, history of keloid tendency, associated diseases and previous treatments. - Assessment of skin type, BMI, degree of AN, HbA1C, site of lesions in all patients and degree of improvement. - Photography: will evaluate the clinical response to treatment for each patient Photos will be taken before starting the study, before every session, and two weeks after the last session. - Melanin index (MI) will be measured using reflectance spectrophotometer in order to assess the degree of hyperpigmentation before starting the study and two weeks after the last session. Research Template 8 Final Version: April 2019 - Acanthosis Nigricans Area and Severity Index (ANASI) score (Zaki et al., 2018) will be done for all patients before starting the study and two weeks after the last session. - Patient satisfaction score will be assessed before starting the study and two weeks after the last session. - Patient evaluation (clinical percentage of improvement). Operation : One side of the affected area will be randomly assigned to fractional CO2 laser every four weeks for three months. The other side will be assigned to Q-switched Nd:YAG laser every four weeks for three months. Method of randomization: Using closed envelopes containing cards with fractional CO2 Rt and fractional CO2 Lt and the patient will draw one of them blindly. The assessment will be done by blinded investigator. Post-operative: Patients will be instructed to avoid sun exposure for one week after the session and regular use of sun block in between sessions.","other_id":"LAS123","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. age more than 18 years old\r\n\r\n          2. both genders\r\n\r\n          3. skin type III to V\r\n\r\n          4. controlled diabetus\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. pregnancy and lactation\r\n\r\n          2. scarring\r\n\r\n          3. active skin infections\r\n\r\n          4. endocrinal disorders\r\n      ","sponsor":"Cairo University","sponsor_type":"Other","conditions":"Acanthosis Nigricans","interventions":[{"intervention_type":"Device","name":"Device: co2 laser","description":"types of laser"}],"outcomes":[{"outcome_type":"primary","measure":"patient evaluation","time_frame":"3 months","description":"Acanthosis nigricans area and severity index is scoring system used to assess patients before the session and after the session to assess finally the improvement"}]}
{"nct_id":"NCT04949867","start_date":"2021-05-20","phase":"Phase 4","enrollment":20,"brief_title":"Dual-Hormone Closed-Loop Glucose Control in Adolescents With Type 1 Diabetes","official_title":"Dual-Hormone Closed-Loop Glucose Control in Adolescents With Type 1 Diabetes","primary_completion_date":"2022-06-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-04-01","last_update":"2021-07-12","description":"Objective: To assess the efficacy and safety of an insulin-glucagon dual-hormone (DH) closed-loop system compared with an insulin-only single-hormone (SH) closed-loop system in adolescent with type 1 diabetes. Methods: In a 26-h, randomized, crossover, inpatient study, 20 children and adolescents with type 1 diabetes used two modes of the DiaCon Artificial Pancreas system: DH and SH closed-loop control. During each study period, participants will have one overnight stay, received three meals and performed exercise for 45 min (bicycle with estimated 50% V02max). Endpoint: The primary endpoint is sensor-derived percentage of time in hypoglycemia (<3.9 mmol/L).","other_id":"H-21000207","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Single","intervention_model_description":"A randomized, single-blinded, cross-over study of glycemic control during dual-hormone therapy compared with single-hormone therapy in adolescents with type 1 diabetes.","sampling_method":"","gender":"All","minimum_age":13,"maximum_age":17,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age = 13-17 years\r\n\r\n          -  T1D duration  2 years\r\n\r\n          -  Insulin pump therapy  1 year\r\n\r\n          -  Using CGM or isCGM (Flash Libre)\r\n\r\n          -  HbA1c  9.0% (75 mmol/mol)\r\n\r\n          -  Using carbohydrate counting\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Allergy to glucagon or lactose\r\n\r\n          -  Allergy to faster insulin aspart (FiAsp)\r\n\r\n          -  Pheochromocytoma\r\n\r\n          -  Self-reported lack of hypoglycemia symptoms when blood glucose is < 3.0 mmol/l\r\n\r\n          -  Inability to follow study procedures, e.g. exercise, sleeping, blood sampling, and\r\n             meal intake\r\n\r\n          -  Pregnancy, nursing, plan to become pregnant or sexually active and not using adequate\r\n             contraceptive methods (intrauterine device, contraceptive pill, patch or injection)\r\n\r\n          -  Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs\r\n             affecting glucose metabolism during or within 30 days prior to study participation\r\n\r\n          -  Other concomitant medical or psychological condition that according to the\r\n             investigator's assessment makes the participant unsuitable for study participation\r\n      ","sponsor":"Steno Diabetes Center Copenhagen","sponsor_type":"Other","conditions":"Type 1 Diabetes","interventions":[{"intervention_type":"Drug","name":"Drug: Glucagon","description":"Glucagon is filled in the pump and given automatically in case of hypoglycemia or pending hypoglycemia."},{"intervention_type":"Device","name":"Device: Closed-loop System","description":"Closed-loop system comprise of two DANA RS (R) insulin pumps (FiAsp-GlucaGen vs FiAsp-saline), one DexCom G6 sensor, and a smartphone for the control algorithm."}],"outcomes":[{"outcome_type":"secondary","measure":"Physical activity intensity measured by ActiGraph GT9X Link","time_frame":"26 hours","description":"Percentage of sedentary activity"},{"outcome_type":"secondary","measure":"Sleep efficiency measured by ActiGraph GT9X Link","time_frame":"26 hours","description":"The ratio of total sleep time to time in bed"},{"outcome_type":"primary","measure":"Percentage of time with glucose values < 3.9 mmol/l as measured by the continuous glucose monitor","time_frame":"26 hours during closed-loop control","description":"Percentage"},{"outcome_type":"secondary","measure":"Number of carbohydrate interventions to treat hypoglycemia","time_frame":"26 hours during closed-loop control"},{"outcome_type":"secondary","measure":"Percentage of time with glucose values in the range 3.9-10.0 mmol/l measured by continuous glucose monitor and plasma glucose","time_frame":"26 hours during closed-loop control","description":"Percentage"},{"outcome_type":"secondary","measure":"Percentage of time with glucose values < 3.9 mmol/l as measured by plasma glucose","time_frame":"26 hours during closed-loop control","description":"Percentage"},{"outcome_type":"secondary","measure":"Percentage of time with glucose values in the range > 13.9 mmol/l measured by continuous glucose monitor and plasma glucose","time_frame":"26 hours during closed-loop control","description":"Percentage"},{"outcome_type":"secondary","measure":"Percentage of time with glucose values < 3.0 mmol/l as measured by continuous glucose monitor and plasma glucose","time_frame":"26 hours during closed-loop control","description":"Percentage"},{"outcome_type":"secondary","measure":"Mean blood glucose value measured by continuous glucose monitor and plasma glucose","time_frame":"26 hours during closed-loop control","description":"mmol/L"},{"outcome_type":"secondary","measure":"Number of hypoglycemic episodes < 3.9 mmol/l on continuous glucose monitor and plasma glucose","time_frame":"26 hours during closed-loop control","description":"No."},{"outcome_type":"secondary","measure":"Continuous glucose monitored glycemic variability measured as SD","time_frame":"26 hours during closed-loop control","description":"mmol/L"},{"outcome_type":"secondary","measure":"Continuous glucose monitored glycemic variability measured as CV","time_frame":"26 hours during closed-loop control","description":"percentage"},{"outcome_type":"secondary","measure":"Composite outcome: Percentage of participants achieving (1) time in range (3.9-10) > 70 %, (2) time in alert hypoglycemia (<3.9 mmol/l) < 4 %, and (3) time in clinical hypoglycemia (<3.0 mmol) < 1% as measured by CGM and YSI","time_frame":"26 hours during closed-loop control","description":"percentage"},{"outcome_type":"secondary","measure":"Total insulin dose","time_frame":"26 hours during closed-loop control","description":"units"},{"outcome_type":"secondary","measure":"Total glucagon dose","time_frame":"26 hours during closed-loop control","description":"mg"},{"outcome_type":"secondary","measure":"Number of manual insulin boluses","time_frame":"26 hours during closed-loop control","description":"No."},{"outcome_type":"secondary","measure":"Number of adverse events - Nausea","time_frame":"26 hours during closed-loop control","description":"No of event if visual analog scale (0-100) increase >10 from baseline"},{"outcome_type":"secondary","measure":"Number of adverse events - Headache","time_frame":"26 hours during closed-loop control","description":"No of event if visual analog scale (0-100) increase >10 from baseline"},{"outcome_type":"secondary","measure":"Number of adverse events - Palpitation","time_frame":"26 hours during closed-loop control","description":"No of event if visual analog scale (0-100) increase >10 from baseline"},{"outcome_type":"secondary","measure":"Number of vomits","time_frame":"26 hours during closed-loop control","description":"No of event if visual analog scale (0-100) increase >10 from baseline"},{"outcome_type":"secondary","measure":"Difference between actual and participant-estimated carbohydrate content in meals","time_frame":"26 hours of closed-loop glucose control","description":"g per meal"},{"outcome_type":"secondary","measure":"Mean Borg scale","time_frame":"During 45 minutes exercise","description":"Scale of perceived exertion from 6 (no effort activity) to 20 (max effort activity)"}]}
{"nct_id":"NCT04483206","start_date":"2021-05-20","phase":"Phase 1","enrollment":90,"brief_title":"Personalized Autologous Transplant for Multiple Myeloma","official_title":"Phase 1 of Exposure Targeted Melphalan Dosing","primary_completion_date":"2022-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-12-31","last_update":"2021-06-03","description":"This phase I trial studies the best dose and side effects of mephalan in treating patients with multiple myeloma who are undergoing stem cell transplant. Chemotherapy drugs, such as mephalan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial uses a new method of dosing that is based on analysis of each individual's blood levels of melphalan after receiving a part of the dose, termed pharmacokinetic analysis. This may help to learn more about how to dose melphalan correctly and which patients are likely to benefit from a personalized dose.","other_id":"STUDY00000449","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patient must have the clinical diagnosis of a plasma cell neoplasm requiring treatment\r\n             per the treating physician using the International Myeloma Working Group (IMWG) and\r\n             World Health Organization (WHO) criteria as guidelines. This can include extraosseous\r\n             plasmacytoma, monoclonal immunoglobulin deposition disease, and heavy-chain diseases\r\n             as these diagnoses, while rare, can be treated in part with autologous transplant\r\n\r\n          -  If enrolling in phase A of this protocol, the patient\r\n\r\n               -  must have received 2+ lines of therapy as defined by the IMWG; and\r\n\r\n               -  Must have estimated glomerular filtration rate (eGFR) by Cockcroft-Gault > 40\r\n                  mL/min; and\r\n\r\n               -  Be eligible and appropriate per the treating physician to receive 200 mg/m^2\r\n\r\n                    -  If enrolling in phase B of the protocol, the transplant must be part of\r\n                       first line therapy to provide some level of homogeneity for toxicity\r\n                       assessment and preliminary efficacy\r\n\r\n          -  Absolute neutrophil count (ANC) >= 1000/uL\r\n\r\n          -  Platelet count >= 100,000\r\n\r\n          -  Total bilirubin < 1.5 x institutional upper limit of normal (unless the patient has an\r\n             established diagnosis of Gilbert's in which case total bilirubin < 3 mg/dL)\r\n\r\n          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x the\r\n             institutional upper limit of normal\r\n\r\n          -  Left ventricular ejection fraction >= 45%\r\n\r\n          -  Diffusion capacity of the lung for carbon monoxide (DLCO), forced expiratory volume in\r\n             1 second (FEV1), and forced vital capacity (FVC) > 50% of predicted value (corrected\r\n             for hemoglobin)\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)\r\n             is required for eligibility. Those patients with lower performance status based solely\r\n             on bone pain secondary to multiple myeloma are eligible\r\n\r\n          -  Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy\r\n             test prior to starting therapy. The effects of protocol therapy on the developing\r\n             human fetus are unknown. For this reason, FCBP and men must agree to use adequate\r\n             contraception (hormonal or barrier method of birth control; abstinence) prior to study\r\n             entry and for the duration of study participation. Should a woman become pregnant or\r\n             suspect she is pregnant while she or her partner is participating in this study, she\r\n             should inform her treating physician immediately. Men treated or enrolled on this\r\n             protocol must also agree to use adequate contraception prior to the study, for the\r\n             duration of study participation, and 3 months after completion of protocol therapy\r\n             administration. Female of childbearing potential (FCBP) is a sexually mature woman\r\n             who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been\r\n             naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at\r\n             any time in the preceding 24 consecutive months)\r\n\r\n          -  The patient must be willing to comply with fertility requirements\r\n\r\n          -  Ability to understand and the willingness to sign a written informed consent document\r\n\r\n          -  Patients with a prior or concurrent malignancy whose natural history or treatment does\r\n             not have the potential to interfere with the safety or efficacy assessment of the\r\n             investigational regimen are eligible for this trial\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients known to meet criteria for progressive disease or clinical relapse between\r\n             screening and planned melphalan infusion day -3\r\n\r\n          -  Subject has any of the following cardiac abnormalities\r\n\r\n               -  History of clinically significant cardiovascular disease with New York Heart\r\n                  Association class III or IV congestive heart failure or\r\n\r\n               -  Severe nonischemic cardiomyopathy or\r\n\r\n               -  Myocardial infarction within the previous 6 months prior to starting study\r\n                  treatment\r\n\r\n               -  Unstable or poorly controlled angina\r\n\r\n               -  Uncontrolled severe hypertension\r\n\r\n               -  Clinically/hemodynamically significant arrythmias\r\n\r\n               -  Severe uncontrolled cardiac arrhythmias (grade 3 or higher) or\r\n\r\n               -  Clinically significant electrocardiogram (ECG) abnormalities includingcorrected\r\n                  QT interval (QTc) > 480 msec\r\n\r\n          -  Human immunodeficiency virus (HIV) positive EXCEPT if the patient meets all the\r\n             following: CD4 > 350 cells/mm^3, undetectable viral load, maintained on modern\r\n             therapeutic regimen utilizing non CYP interacting agents (e.g. excluding ritonavir),\r\n             and no untreated acquired immune deficiency syndrome defining opportunistic\r\n             infections.\r\n\r\n          -  Seropositive for hepatitis B surface antigen [HBsAg]) EXCEPT subjects with resolved\r\n             infection (ie, subjects who are positive for antibodies to hepatitis B core antigen\r\n             [antiHBc] and/or antibodies to hepatitis B surface antigen [antiHBs]) must be screened\r\n             using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV)\r\n             DNA levels. Those who are PCR positive will be excluded. Subjects with serologic\r\n             findings suggestive of HBV vaccination (antiHBs positivity as the only serologic\r\n             marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV\r\n             DNA by PCR\r\n\r\n          -  Seropositive for hepatitis C except in the setting of a sustained virologic response\r\n             [SVR], defined as without viremia for at least 12 weeks after completion of antiviral\r\n             therapy\r\n\r\n          -  Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin change\r\n             (POEMS) syndrome, amyloid light-chain (AL) amyloidosis, and Waldenstrom\r\n             macroglobulinemia\r\n\r\n          -  Concurrent medical condition or disease (eg, active systemic infection) that is likely\r\n             to interfere with study procedures or results, or that in the opinion of the\r\n             investigator would constitute a hazard for participating in this study\r\n\r\n          -  Known or suspected of not being able to comply with the study protocol (eg, because of\r\n             alcoholism, drug dependency, or psychological disorder) or the subject has any\r\n             condition for which, in the opinion of the investigator, participation would not be in\r\n             the best interest of the subject (eg, compromise their well-being) or that could\r\n             prevent, limit, or confound the protocol-specified assessments\r\n\r\n          -  Pregnant women are excluded from this study because protocol therapy has the potential\r\n             for teratogenic or abortifacient effects. Because there is an unknown but potential\r\n             risk for adverse events in nursing infants secondary to protocol treatment of the\r\n             mother, breastfeeding should be discontinued\r\n      ","sponsor":"Emory University","sponsor_type":"Other","conditions":"Multiple Myeloma","interventions":[{"intervention_type":"Procedure","name":"Procedure: Autologous Hematopoietic Stem Cell Transplantation","description":"Undergo ASCT"},{"intervention_type":"Drug","name":"Drug: Melphalan","description":"Given IV"},{"intervention_type":"Other","name":"Other: Questionnaire Administration","description":"Ancillary studies"}],"outcomes":[{"outcome_type":"primary","measure":"Predicted versus observed total melphalan area under the curve (AUC)","time_frame":"At Days -3 and -1","description":"Will be measured using pharmacokinetic data from the day -3 and day -1 dose."},{"outcome_type":"primary","measure":"Incidence of exposure limiting toxicity","time_frame":"During the first 30-days of treatment","description":"Will measure proportion of patients with clinically significant mucositis, tachyarrhythmia, and delayed engraftment. Toxicity will be evaluated according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) guidelines."},{"outcome_type":"primary","measure":"Minimal residual disease (MRD) negativity post-transplant","time_frame":"Up to 90 days post-transplant","description":"MRD status will be determined per International Myeloma Working Group (IMWG) criteria using next generation sequencing in patients with suspected complete response (CR)."},{"outcome_type":"secondary","measure":"Overall response rate","time_frame":"Up to 90 days post transplantation","description":"The number and percentage of subjects experiencing objective response will be descriptively summarized overall and by cohort. Responders will be defined as those that achieve best response of partial response (PR) or better defined according to the IMWG Uniform response criterion. CR rate will be calculated with an exact 95% confidence interval, both within cohorts but not between cohorts."},{"outcome_type":"secondary","measure":"Incidence of selected grade 3/4 toxicities at the recommended AUC range","time_frame":"Up to 60 days post transplantation","description":"The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. Adverse events will be summarized and described within each cohort. They will initially be reviewed regardless of attribution, but also whether they are possibly, probably, or definitely related to treatment. In addition, will review all adverse event data that are graded as 3, 4, or 5 and classified as either \"unrelated\" or \"unlikely to be related\" to study treatment in the event of an actual relationship developing. The incidence of severe adverse events or toxicities will be described. Will assess the proportion of patients who experience grade 3 or higher non-hematologic toxicity. To assess tolerability, will also capture the proportion of patients who go off treatment due to adverse events."}]}
{"nct_id":"NCT05002933","start_date":"2021-05-20","phase":"Phase 4","enrollment":570,"brief_title":"A Clinical Efficacy and Safety Study of Insulin Glargine U300 in Chinese Adult Patients With Uncontrolled Type 2 Diabetes Mellitus With a 3-month Extension Period","official_title":"A 6-month, Multicenter, Prospective, Single-arm, Open-label, Phase IV Study Evaluating the Clinical Efficacy and Safety of Insulin Glargine U300 in Chinese Adult Patients With Uncontrolled Type 2 Diabetes Mellitus With a 3-month Extension Period","primary_completion_date":"2023-10-18","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-10-18","last_update":"2021-08-24","description":"This is a prospective, interventional, single arm, multicenter, phase 4 study to evaluate the clinical efficacy and safety of initiating Insulin glargine U300 in insulin-naive patients or switching from any other basal insulin to Insulin glargine U300 in insulin pre-treated patients with uncontrolled T2DM.","other_id":"LPS16585","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adult patients (age18 years) who diagnosed with type 2 diabetes\r\n\r\n          -  Patients who should initiate Insulin glargine U300 treatment following local label and\r\n             guideline at investigator's discretion, including:\r\n\r\n               -  insulin naive patients (no current or previous insulin used during the last year\r\n                  prior to screening except for a maximum 10 days in relation to acute illness or\r\n                  surgery, etc.) uncontrolled (HbA1c between 7.5% and 11.0%) at screening visit on\r\n                  stable dose treatment with  2 OADs (metformin, sulfonylurea, thiazolidinedione,\r\n                  DPP-4 inhibitor, SGLT-2 inhibitor, glinide, -glucosidase inhibitor) within 8\r\n                  weeks prior to screening, at least one of which must be on maximum tolerated\r\n                  dose, or\r\n\r\n               -  patients uncontrolled (HbA1c between 7.5% and 11.0%) at screening visit with\r\n                  other basal insulin, or\r\n\r\n               -  patients controlled with other basal insulin but experienced frequent\r\n                  hypoglycemia or with increased hypoglycemia risk at investigator's discretion\r\n\r\n          -  Patients who treated with basal insulin must have a stable dose of antidiabetic drugs\r\n             (dose change no more than 20% vs. the dose on screening visit for basal insulin)\r\n             within 8 weeks prior to screening\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any clinically significant abnormality identified on physical examination, laboratory\r\n             tests, or vital signs at the time of screening, or at baseline, or any major systemic\r\n             disease resulting in short life expectancy that in the opinion of the Investigator\r\n             would restrict or limit the patient's successful participation for the duration of the\r\n             study\r\n\r\n          -  Use of any product containing short or rapid acting insulin in the last 3 months prior\r\n             to screening (unless used for 10 days in relation to hospitalization or an acute\r\n             illness)\r\n\r\n          -  Use of oral anti-diabetic drugs other than those allowed and listed in the inclusion\r\n             criteria, Glucagon-like peptide-1 (GLP-1) receptor agonists, or any investigational\r\n             agent (drug, biologic, device) within 3 months prior to screening visit\r\n\r\n          -  Use of systemic glucocorticoids (excluding topical application or inhaled forms) for\r\n             two weeks or more within 8 weeks prior to the time of screening\r\n\r\n          -  Known hypersensitivity / intolerance to insulin glargine or any of its excipients\r\n\r\n          -  Pregnant or lactating women\r\n\r\n          -  Women of childbearing potential with no effective contraceptive method\r\n\r\n          -  Participation in another clinical trial\r\n\r\n        The above information is not intended to contain all considerations relevant to a patient's\r\n        potential participation in a clinical trial.\r\n      ","sponsor":"Sanofi","sponsor_type":"Industry","conditions":"Type 2 Diabetes Mellitus","interventions":[{"intervention_type":"Drug","name":"Drug: Insulin glargine 300 U/ml","description":"Solution for injection Subcutaneous injection"}],"outcomes":[{"outcome_type":"secondary","measure":"Mean change in fasting Self-Monitored Blood Glucose (SMBG) from baseline to week 12 and week 24","time_frame":"Baseline to Week 12 and 24"},{"outcome_type":"primary","measure":"Mean change in HbA1c from baseline to week 24","time_frame":"Baseline to Week 24"},{"outcome_type":"secondary","measure":"Mean change in HbA1c from baseline to week 12 and week 36","time_frame":"Baseline to Week 12 and 36"},{"outcome_type":"secondary","measure":"Percentage of participants achieving HbA1c target <7%","time_frame":"at Week 12, 24 and 36"},{"outcome_type":"secondary","measure":"Percentage of participants achieving HbA1c target <7% without hypoglycemic events","time_frame":"at Week 12 and 24"},{"outcome_type":"secondary","measure":"Mean change in Fasting Plasma Glucose (FPG) from baseline to week 12, 24 and 36","time_frame":"Baseline to Week 12, 24 and 36"},{"outcome_type":"secondary","measure":"Mean change in of 7-points SMBG per time point from baseline to week 12 and week 24","time_frame":"Baseline to Week 12 and 24"},{"outcome_type":"secondary","measure":"Mean change in Insulin glargine U300 dose from baseline to week 12, 24 and 36","time_frame":"Baseline to Week 12, 24 and 36"},{"outcome_type":"secondary","measure":"Number of participants experiencing hypoglycemia from baseline to week 12, 24 and 36","time_frame":"Baseline to Week 12, 24 and 36"},{"outcome_type":"secondary","measure":"Number of hypoglycemic events per patient-year","time_frame":"Baseline to Week 12, 24 and 36"},{"outcome_type":"secondary","measure":"Number of participants with adverse events","time_frame":"Baseline to Week 24 and 36"},{"outcome_type":"secondary","measure":"Mean change in body weight from baseline to Week 12 and Week 24","time_frame":"Baseline to Week 12 and 24"}]}
{"nct_id":"NCT04539808","start_date":"2021-05-18","phase":"Phase 2","enrollment":60,"brief_title":"NeoOPTIMIZE: Early Switching of mFOLFIRINOX or Gemcitabine/Nab-Paclitaxel Before Surgery for the Treatment of Resectable, Borderline Resectable, or Locally-Advanced Unresectable Pancreatic Cancer","official_title":"NeoOPTIMIZE: An Open-Label, Phase II Trial to Assess the Efficacy of Adaptive Switching of FOLFIRINOX or Gemcitabine/Nab-Paclitaxel as a Neoadjuvant Strategy for Patients With Resectable and Borderline Resectable/Locally Advanced Unresectable Pancreatic Cancer","primary_completion_date":"2024-01-15","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2025-10-05","last_update":"2021-08-24","description":"This phase II trial evaluates whether early switching from modified fluorouracil/irinotecan/leucovorin/oxaliplatin (mFOLFIRINOX) chemotherapy regimen to a combination of gemcitabine and nab-paclitaxel (GA) before surgery is effective in treating patients with pancreatic cancer that can be surgically removed (resectable or borderline resectable), or that has spread to nearby tissue or lymph nodes and cannot be removed by surgery (locally-advanced unresectable). Chemotherapy drugs, such as fluorouracil, irinotecan, leucovorin, oxaliplatin, gemcitabine, and nab-paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The study will also evaluate the drug losartan in combination with mFOLFIRINOX or GA.","other_id":"STUDY00021614","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Ability to understand and the willingness to sign a written informed consent document\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\r\n\r\n          -  Cytologic or histologic proof pancreatic ductal carcinoma is required prior to study\r\n             entry\r\n\r\n               -  If a biopsy (e.g., endoscopic ultrasound [EUS]-guided fine needle aspiration\r\n                  [FNA]) is planned per standard of care, the participant may be asked to consent\r\n                  to the additional collection of tumor tissue for research\r\n\r\n          -  No evidence of metastatic disease as determined by chest computed tomography (CT)\r\n             scan, abdomen/pelvis computed tomography (CT) scan (or magnetic resonance imaging\r\n             [MRI] with gadolinium and/or manganese) within 6 weeks of study entry\r\n\r\n          -  Diagnostic staging laparoscopy is not required for study eligibility\r\n\r\n               -  If staging laparoscopy is planned per standard of care, the participant may be\r\n                  asked to consent to the collection of tumor tissue for research\r\n\r\n          -  At time of screening, per National Comprehensive Cancer Network (NCCN) criteria, must\r\n             have either:\r\n\r\n               -  Resectable pancreatic ductal adenocarcinoma (PDAC), defined as no arterial tumor\r\n                  contact (celiac axis [CA], superior mesenteric artery [SMA], or common hepatic\r\n                  artery [CHA]), or\r\n\r\n               -  Node positive disease as defined by CT, MRI, or EUS imaging, or\r\n\r\n               -  Borderline resectable PDAC, defined as:\r\n\r\n                    -  For tumors of the head or uncinate process:\r\n\r\n                         -  Solid tumor contact with the superior mesenteric vein (SMV) or portal\r\n                            vein of > 180 degrees with contour irregularity of the vein or\r\n                            thrombosis of the vein, but with suitable vessel proximal and distal to\r\n                            the site of involvement, allowing for safe and complete resection and\r\n                            vein reconstruction\r\n\r\n                         -  Solid tumor contact with the inferior vena cava\r\n\r\n                         -  Solid tumor contact with the common hepatic artery without extension to\r\n                            the celiac axis or hepatic artery bifurcation, allowing for safe and\r\n                            complete resection and reconstruction\r\n\r\n                         -  Solid tumor contact with the SMA =< 180 degrees\r\n\r\n                         -  Solid tumor contact with variable anatomy (e.g., accessory right\r\n                            hepatic artery, replaced right hepatic artery, replaced common hepatic\r\n                            artery, and the origin of replaced or accessory artery), and the\r\n                            presence and degree of tumor contact should be noted if present, as it\r\n                            may affect surgical planning\r\n\r\n                    -  For tumors of the body/tail:\r\n\r\n                         -  Solid tumor contact with the celiac axis of =< 180 degrees\r\n\r\n                         -  Solid tumor contact with the celiac axis >180 degrees without\r\n                            involvement of the aorta and with an intact and uninvolved\r\n                            gastroduodenal artery, thereby permitting a modified Appleby procedure\r\n                            (although some members of the consensus committee preferred this\r\n                            criterion to be in the unresectable category)\r\n\r\n               -  Locally-advanced, unresectable disease as defined by NCCN guidelines as follows:\r\n\r\n                    -  Tumors of the head with SMA >= 180 degrees, or any celiac abutment,\r\n                       unreconstractable SMV or portal occlusion, or aortic invasion or encasement\r\n\r\n                    -  Tumors of the body with SMA or celiac encasement 180 degrees,\r\n                       unreconstractable SMV or portal occlusion, or aortic invasion\r\n\r\n                    -  Tumors of the tail with SMA or celiac encasement >= 180 degrees\r\n\r\n                    -  Irrespective of location, all tumors with evidence of nodal metastasis\r\n                       outside of the resection field that are considered unresectable\r\n\r\n          -  Must be deemed fit to undergo planned curative resection as determined by\r\n             institutional standards\r\n\r\n          -  No history of previous chemotherapy for pancreatic cancer. At the discretion of the\r\n             principal investigator (PI), patient that have received no more than 1 month of\r\n             systemic chemotherapy (e.g., mFOLFIRINOX), per standard of care, for the treatment of\r\n             their PDAC may be eligible to participate\r\n\r\n          -  Baseline systolic blood pressure (BP) > 100 mm Hg\r\n\r\n          -  Hemoglobin > 9 g/dL with no blood transfusion within 28 days of starting treatment (at\r\n             time of registration and within 4 weeks prior to initiating study therapy)\r\n\r\n          -  Absolute neutrophil count (ANC) >= 1.0 x 10^9/L (> 1000 cells/mm^3) (at time of\r\n             registration and within 4 weeks prior to initiating study therapy)\r\n\r\n               -  May be waived on a case-by-case basis for patient populations recognized to have\r\n                  normal baseline values below this level\r\n\r\n          -  Platelet count >= 100 x 10^9/L (> 100,000 per mm^3) (at time of registration and\r\n             within 4 weeks prior to initiating study therapy)\r\n\r\n          -  Creatinine =< 1.5 mg/dL OR measured or calculated creatinine clearance (glomerular\r\n             filtration rate [GFR] can also be used in place of creatinine or creatinine clearance\r\n             [CrCl]) >= 30 mL/min/1.73 m^2 for participants with creatinine levels > 1.5 x\r\n             institutional upper limit of normal (ULN) (at time of registration and within 4 weeks\r\n             prior to initiating study therapy)\r\n\r\n               -  Creatinine clearance should be calculated per institutional standard. For\r\n                  participants with a baseline calculated creatinine clearance below normal\r\n                  institutional laboratory values, a measured baseline creatinine clearance should\r\n                  be determined. Individuals with higher values felt to be consistent with inborn\r\n                  errors of metabolism will be considered on a case-by-case basis\r\n\r\n          -  Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN); or =< 2 x ULN or 2\r\n             down-trending values for individuals who have undergone biliary stenting (at time of\r\n             registration and within 4 weeks prior to initiating study therapy)\r\n\r\n          -  Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and\r\n             alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x\r\n             ULN, OR two consecutive down-trending values for individuals who have undergone\r\n             biliary stenting (at time of registration and within 4 weeks prior to initiating study\r\n             therapy)\r\n\r\n          -  Female participants of childbearing potential must have a negative urine or serum\r\n             pregnancy test within 72 hours prior to initiating study therapy. If the urine test is\r\n             positive or cannot be confirmed as negative, a serum pregnancy test will be required\r\n\r\n          -  Female participants of childbearing potential agree to use adequate methods of\r\n             contraception starting with the first dose of study therapy through 30 days after the\r\n             last dose of study therapy\r\n\r\n               -  Participants of childbearing potential are those who have not been surgically\r\n                  sterilized or have not been free from menses for > 1 year without an alternative\r\n                  medical cause\r\n\r\n          -  Male participants must agree to use an adequate method of contraception starting with\r\n             the first dose of study therapy through 30 days after the last dose of study therapy\r\n\r\n          -  Male patients must use a condom during treatment when having sexual intercourse with a\r\n             pregnant woman or with a woman of childbearing potential. Female partners of male\r\n             participant should also use a highly effective form of contraception if they are of\r\n             childbearing potential\r\n\r\n          -  Participants currently receiving an angiotensin-converting enzyme (ACE) inhibitor or\r\n             angiotensin II receptor blocker (ARB) will remain eligible for study participation. In\r\n             such cases, losartan will not be assigned as part of the study intervention. These\r\n             participants will continue to receive their ACE inhibitor or ARB per standard-of-care.\r\n             The ACE inhibitor or ARB type should be recorded as a concomitant medication\r\n             (including dose and frequency)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of previous chemotherapy (other than no more than one cycle of standard\r\n             systemic chemotherapy), targeted/biologic therapy, or radiation therapy for the\r\n             treatment of their PDAC\r\n\r\n          -  Evidence of metastasis to distant organs (liver, peritoneum, lung, others)\r\n\r\n          -  Any other active malignancy or prior history of malignancy with less than a 90% cure\r\n             rate in the judgement of the investigators\r\n\r\n          -  Medical co-morbidities that are deemed to make risk of surgery unacceptably high as\r\n             determined by institutional standards\r\n\r\n          -  Personal history of any of the following conditions: syncope of cardiovascular\r\n             etiology, ventricular arrhythmia of pathological origin (including, but not limited\r\n             to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest\r\n\r\n          -  Recent major surgery (excluding laparoscopy) within 4 weeks prior to starting study\r\n             treatment. Minor surgery within 2 weeks of starting study treatment. Patients must be\r\n             recovered from effects of surgery\r\n\r\n          -  Concomitant use of other anti-cancer therapy (chemotherapy, immunotherapy, hormonal\r\n             therapy [hormone replacement therapy is acceptable]), not otherwise allowed in this\r\n             study\r\n\r\n          -  Participants receiving any other study agents\r\n\r\n          -  Participants with a history of hypersensitivity reactions to study agents or their\r\n             excipients\r\n\r\n          -  Participant is pregnant or breastfeeding, or expecting to conceive or father children\r\n             within the projected duration of the trial, starting with the screening visit through\r\n             30 days after the last dose of trial therapy\r\n\r\n          -  Psychiatric illness/social situations, or any condition that, in the opinion of the\r\n             investigator, would: interfere with evaluation of study treatment or interpretation of\r\n             participant safety or study results, or substantially increase risk of incurring\r\n             adverse events (AEs), or compromise the ability of the patient to give written\r\n             informed consent\r\n\r\n          -  Judgment by the investigator that the patient should not participate in the study if\r\n             the patient is unlikely to comply with study procedures, restrictions and requirements\r\n      ","sponsor":"OHSU Knight Cancer Institute","sponsor_type":"Other","conditions":"Borderline Resectable Pancreatic Carcinoma|Locally Advanced Unresectable Pancreatic Adenocarcinoma|Resectable Pancreatic Ductal Adenocarcinoma|Stage 0 Pancreatic Cancer AJCC v8|Stage I Pancreatic Cancer AJCC v8|Stage IA Pancreatic Cancer AJCC v8|Stage IB Pancreatic Cancer AJCC v8|Stage III Pancreatic Cancer AJCC v8|Stage IV Pancreatic Cancer AJCC v8","interventions":[{"intervention_type":"Drug","name":"Drug: Capecitabine","description":"Given PO"},{"intervention_type":"Drug","name":"Drug: Fluorouracil","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: Irinotecan Hydrochloride","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: Leucovorin Calcium","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: Losartan Potassium","description":"Given PO"},{"intervention_type":"Drug","name":"Drug: Oxaliplatin","description":"Given IV"},{"intervention_type":"Radiation","name":"Radiation: Radiation Therapy","description":"Undergo short-course or long-course RT"},{"intervention_type":"Procedure","name":"Procedure: Resection","description":"Undergo surgical resection"}],"outcomes":[{"outcome_type":"primary","measure":"Proportion of participants with R0 resection","time_frame":"Up to time of surgery","description":"Using the surgery analysis set, the proportion of participants with R0 resection will be estimated with exact 95% confidence interval."},{"outcome_type":"secondary","measure":"Progression-free survival (PFS) NeoOPTIMIZE","time_frame":"From the start of neoadjuvant therapy (day 1) to the time of tumor progression, or death due to any cause, assessed up to 24 months","description":"Using the efficacy analysis set, the estimated distribution of the PFS will be plotted using Kaplan Meier curves and reported with median survival and 95% confidence intervals if available. When feasible, sub-group analyses for the different treatment regimens (i.e., gemcitabine/nab-paclitaxel [GA] or modified fluorouracil/irinotecan/leucovorin/oxaliplatin [mFOLFIRINOX] +/- radiation therapy [RT] [i.e., short- or long-course, or both RT modalities combined]) will be performed for PFS."},{"outcome_type":"secondary","measure":"PFSNeoOPTIMIZE + pre-operative (preop)-RT","time_frame":"From the start of neoadjuvant therapy (day 1) to the time of tumor progression, or death due to any cause, assessed up to 24 months","description":"Using the efficacy analysis set, the estimated distribution of the PFS will be plotted using Kaplan Meier curves and reported with median survival and 95% confidence intervals if available. When feasible, sub-group analyses for the different treatment regimens (i.e., GA or mFOLFIRINOX +/- RT [i.e., short- or long-course, or both RT modalities combined]) will be performed for PFS."},{"outcome_type":"secondary","measure":"Disease-free survival (DFS) NeoOPTIMIZE","time_frame":"From the date of surgery to the time of tumor progression, or death due to any cause, assessed up to 24 months","description":"Using the surgery analysis set, the estimated distribution of the DFS will be plotted using Kaplan Meier curves and reported with median survival and 95% confidence intervals if available. Using the efficacy analysis set, the estimated distribution of the DFS will be plotted using Kaplan Meier curves and reported with median survival and 95% confidence intervals if available. When feasible, sub-group analyses for the different treatment regimens (i.e., GA or mFOLFIRINOX +/- RT [i.e., short- or long-course, or both RT modalities combined]) will be performed for DFS."},{"outcome_type":"secondary","measure":"DFSNeoOPTIMIZE + preop-RT","time_frame":"From the date of surgery to the time of tumor progression, or death due to any cause, assessed up to 24 months","description":"Using the efficacy analysis set, the estimated distribution of the DFS will be plotted using Kaplan Meier curves and reported with median survival and 95% confidence intervals if available. When feasible, sub-group analyses for the different treatment regimens (i.e., GA or mFOLFIRINOX +/- RT [i.e., short- or long-course, or both RT modalities combined]) will be performed for DFS."},{"outcome_type":"secondary","measure":"Overall survival (OS) NeoOPTIMIZE","time_frame":"From the start of neoadjuvant therapy (day 1) to death due to disease, assessed up to 24 months","description":"Using the efficacy analysis set, the estimated distribution of the OS will be plotted using Kaplan Meier curves and reported with median survival and 95% confidence intervals if available. Using the efficacy analysis set, the estimated distribution of the OS will be plotted using Kaplan Meier curves and reported with median survival and 95% confidence intervals if available. When feasible, sub-group analyses for the different treatment regimens (i.e., GA or mFOLFIRINOX +/- RT [i.e., short- or long-course, or both RT modalities combined]) will be performed for OS."},{"outcome_type":"secondary","measure":"OSNeoOPTIMIZE + preop-RT","time_frame":"From the start of neoadjuvant therapy (day 1) to death due to disease, assessed up to 24 months","description":"Using the efficacy analysis set, the estimated distribution of the OS will be plotted using Kaplan Meier curves and reported with median survival and 95% confidence intervals if available. When feasible, sub-group analyses for the different treatment regimens (i.e., GA or mFOLFIRINOX] +/- RT [i.e., short- or long-course, or both RT modalities combined]) will be performed for OS."},{"outcome_type":"secondary","measure":"Proportion of participants with peri- and post-operative complications","time_frame":"Up to 30 days after surgery","description":"Peri- and post-operative complications occurring within 30 days following surgery will be categorized per the Clavien-Dindo classification system. Using the surgery analysis set, the proportion of participants with peri- and post-operative complications occurring within 30 days following surgery."},{"outcome_type":"secondary","measure":"Proportion of participants that die within 30 days of surgery","time_frame":"At 30 days post-surgery","description":"The proportion of 30-day post-operative mortality will be estimated and reported with two-sided exact 95% confidence intervals. If necessary, the proportion of 30-day post-operative mortality may be estimated from the Kaplan Meier product limit method."},{"outcome_type":"secondary","measure":"Incidence of grade >= 3 toxicities","time_frame":"Up to 90 days after last dose of protocol-directed therapy","description":"The incidence of grade >= 3 toxicities per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 will be determined using the safety analysis set. The exact 95% confidence interval will be reported with the point estimate of toxicity rate. Adverse events will be tabulated by the Medical Dictionary for Regulatory Activities (MedDRA version 21.1) preferred term and system organ class and a preferred term. The severity of the adverse events (AE) will be assessed by National Cancer Institute (NCI) CTCAE v 5.0 criteria. Descriptive statistics using the safety analysis set will be used to report on all on-study AEs, grade 3-4 AEs, treatment-related AEs, grade 3-4 treatment-related AEs, serious adverse events (SAEs), treatment-related SAEs, and AEs leading to discontinuation per CTCAE v 5.0. Grade 3-4 laboratory abnormalities will be summarized using worst grade NCI CTCAE v 5.0 criteria."},{"outcome_type":"other","measure":"CA19-9 serum levels (U/ml)","time_frame":"Baseline up to 24 months","description":"Using the safety analysis set, the levels of CA19-9 will be descriptively reported (across all participants)."},{"outcome_type":"other","measure":"Proportion of LAPC participants with R0 resection","time_frame":"From the start of neoadjuvant therapy (day 1) to time of surgery","description":"Will be estimated with exact 95% confidence interval."},{"outcome_type":"other","measure":"PFSNeoOPTMIZE for LAPC cohort","time_frame":"From the start of neoadjuvant therapy (day 1) to time of tumor progression, or death due to any cause (up to 24 months from start of study treatment)","description":"Results will be qualitatively described when statistical measures are not feasible."},{"outcome_type":"other","measure":"PFSNeoOPTMIZE + preop-RT for LAPC subset","time_frame":"From the start of neoadjuvant therapy (day 1) to time of tumor progression, or death due to any cause (up to 24 months from start of study treatment)","description":"Results will be qualitatively described when statistical measures are not feasible."},{"outcome_type":"other","measure":"DFSNeoOPTMIZE for LAPC cohort","time_frame":"From date of surgery to time of tumor progression, or death due to any cause (up to 24 months from start of study treatment)","description":"Results will be qualitatively described when statistical measures are not feasible."},{"outcome_type":"other","measure":"DFSNeoOPTMIZE + preop-RT for LAPC subset","time_frame":"From date of surgery to time of tumor progression, or death due to any cause (up to 24 months from start of study treatment)","description":"Results will be qualitatively described when statistical measures are not feasible."},{"outcome_type":"other","measure":"OSNeoOPTMIZE for LAPC cohort","time_frame":"From the start of neoadjuvant therapy (day 1) to death due to any cause, assessed up to 24 months from start of study treatment","description":"Results will be qualitatively described when statistical measures are not feasible."},{"outcome_type":"other","measure":"OSNeoOPTMIZE + preop-RT for LAPC subset","time_frame":"From the start of neoadjuvant therapy (day 1) to death due to any cause, assessed up to 24 months from start of study treatment","description":"Results will be qualitatively described when statistical measures are not feasible."},{"outcome_type":"other","measure":"Proportion of LAPC participants with peri- and post-operative complications","time_frame":"From date of surgery to within 30 days from date of surgery","description":"Assessed per the Clavien-Dindo classification system. Results will be qualitatively described when statistical measures are not feasible."},{"outcome_type":"other","measure":"Proportion of LAPC participants who die within 30 days of surgery","time_frame":"From date of surgery to 30 days post-surgery","description":"Results will be qualitatively described when statistical measures are not feasible."}]}
{"nct_id":"NCT04871802","start_date":"2021-05-10","phase":"N/A","enrollment":100,"brief_title":"Effect of the Dietary Supplement Taxifolin Aqua on the Recovery Period After COVID-19 Pneumonia","official_title":"A Prospective, Randomized, Comparative Study in Two Groups to Assess the Effect of the Use of a Dietary Supplement Taxifolin Aqua on the Recovery Period After COVID Pneumonia and on the Biological Age","primary_completion_date":"2021-09-01","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2021-10-01","last_update":"2021-05-04","description":"Objective of the study is to evaluate the effect of Taxifolin Aqua therapy on the indicators of respiratory function, the state of the arterial wall, the contractile function of the myocardium, as well as to assess the effect of Taxifolin Aqua therapy on markers of biological age, quality of patients life.","other_id":"COVID-AQUA-1","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Patients of both sexes who had covid pneumonia 3 months ago and signed an informed consent\r\n        and aged 18+.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Standard contraindications to Taxifolin Aqua use.\r\n      ","sponsor":"Pirogov Russian National Research Medical University","sponsor_type":"Other","conditions":"Covid19","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Taxifolin Aqua","description":"Dietary supplement"}],"outcomes":[{"outcome_type":"primary","measure":"Dynamics of spirometry indices","time_frame":"In 2 months after recruitment","description":"spirometry"},{"outcome_type":"primary","measure":"Dynamics of ECHO CG","time_frame":"In 2 months after recruitment","description":"ECHO CG"},{"outcome_type":"primary","measure":"Dynamics of pulse wave velocity","time_frame":"In 2 months after recruitment","description":"applanation tonometry"},{"outcome_type":"primary","measure":"Dynamics of augmentation index","time_frame":"In 2 months after recruitment","description":"applanation tonometry"},{"outcome_type":"secondary","measure":"Dynamics of biological age","time_frame":"In 2 months after recruitment","description":"Laboratory indicators"}]}
{"nct_id":"NCT04808401","start_date":"2021-05-07","phase":"N/A","enrollment":110,"brief_title":"Influence of Oxygen on Perioperative Outcome in Patients Undergoing General Anaesthesia for Elective Non-cardiac Surgery","official_title":"Influence of Different Inspired Oxygen Fractions on Perioperative Myocardial Biomarkers, Myocardial Strain and Outcome in Patients Undergoing General Anaesthesia for Elective Non-cardiac Surgery: A Prospective Randomized Open-label Single Centre Pilot Study","primary_completion_date":"2022-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-12-31","last_update":"2021-05-11","description":"The purpose of this study is to investigate the impact of supraphysiologic oxygen (hyperoxia) on myocardial function in anaesthetized patients undergoing non-cardiac vascular surgery.","other_id":"2020_02560","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"Single","intervention_model_description":"Patients start with a crossover design undergoing both TEE images at normoxia and hyperoxia in random order and then are randomized a second time to receive either normoxia or hyperoxia for the remaining procedure in a parallel design.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Written informed consent\r\n\r\n          -  Patients eligible for the study should be scheduled for elective or non-emergent\r\n             non-cardiac vascular surgery under general anaesthesia with endotracheal intubation,\r\n             and have either\r\n\r\n          -  proven CAD and will undergo high- or intermediate surgical risk procedure according to\r\n             European (European Society of Cardiology, ESC / European Society of Anaesthesiology\r\n             and Intensive Care, ESAIC) guidelines on non-cardiac surgery.\r\n\r\n        or\r\n\r\n          -  two or more risk factors for CAD and will undergo high- or intermediate surgical risk\r\n             procedures according to European ESC/ESAIC guidelines on non-cardiac surgery.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Acute coronary event 30 days before surgery\r\n\r\n          -  Acute congestive heart failure\r\n\r\n          -  Hemodynamic instability before induction of aneasthesia (vasopressor or inotrope\r\n             infusion since hospitalization for index surgery)\r\n\r\n          -  Atrial fibrillation or other severe arrhythmia\r\n\r\n          -  Severe pulmonary disease (dependent on oxygen therapy or the Global Initiative for\r\n             Chronic Obstructive Lung Disease (GOLD) stage 4 or severe carbon monoxide diffusion\r\n             impairment or severe pulmonary hypertension)\r\n\r\n          -  Preoperative oxygen saturation (SpO2) below 90% on room air\r\n\r\n          -  Increased risk of oxygen toxicity (e.g., chemotherapy for malignancy within 3 months,\r\n             bleomycin treatment, airway laser surgery)\r\n\r\n          -  Scheduled surgery in the thoracic cavity\r\n\r\n          -  ICU admission for respirator weaning and delayed extubation\r\n\r\n          -  Pre-existing surgical site infection (SSI)\r\n\r\n          -  Current active signs of systemic inflammatory response syndrome (SIRS) or sepsis\r\n             according The Third International Consensus Definitions for Sepsis and Septic Shock\r\n             (Sepsis-3)\r\n\r\n          -  Pregnancy\r\n\r\n          -  Emergency surgery (to be performed within less than 12 hours of scheduling)\r\n\r\n          -  Ambulatory surgery\r\n\r\n          -  Baseline hs-TnT level elevated above 65ng/L\r\n      ","sponsor":"University Hospital Inselspital, Berne","sponsor_type":"Other","conditions":"Coronary Artery Disease|Anesthesia","interventions":[{"intervention_type":"Drug","name":"Drug: Oxygen","description":"Two FIO2 settings during stable general anaesthesia resulting in normoxaemic and hyperoxic arterial oxygen partial pressures."}],"outcomes":[{"outcome_type":"secondary","measure":"Difference in myocardial time to peak displacement between oxygen levels","time_frame":"Through study completion, within 1hour post-induction","description":"Milliseconds (ms)"},{"outcome_type":"primary","measure":"Difference in hsTnT from preoperative baseline","time_frame":"at 24 hours after surgery","description":"ng/L"},{"outcome_type":"secondary","measure":"Incidence of myocardial injury in non-cardiac surgery (MINS)","time_frame":"at 24 hours after surgery","description":"MINS is defined as an absolute change of hsTnT levels of at least 5ng/L from preoperative baseline or an hs-TnT level of at least 65ng/L"},{"outcome_type":"secondary","measure":"Difference in high sensitive TnT from preoperative baseline","time_frame":"at 2 hours after surgery","description":"ng/L"},{"outcome_type":"secondary","measure":"Differences in N-terminal pro B-type natriuretic peptide (NT-proBNP) from preoperative baseline","time_frame":"at 2 hours and 24 hours after surgery","description":"pg/ml"},{"outcome_type":"secondary","measure":"Differences in heart type fatty acid binding protein (H-FABP) from preoperative baseline","time_frame":"at 2 hours and 24 hours after surgery","description":"pg/ml"},{"outcome_type":"secondary","measure":"Difference in myocardial time to peak strain between oxygen levels","time_frame":"Through study completion, within 1hour post-induction","description":"Milliseconds (ms)"},{"outcome_type":"secondary","measure":"Difference in myocardial strain rate between oxygen levels","time_frame":"Through study completion, within 1hour post-induction","description":"Change in strain over time (/second)"},{"outcome_type":"secondary","measure":"Difference in myocardial strain rate ratio between oxygen levels","time_frame":"Through study completion, within 1hour post-induction","description":"Change in E/A ratio"},{"outcome_type":"secondary","measure":"Difference in myocardial displacement between oxygen levels","time_frame":"Through study completion, within 1hour post-induction","description":"Millimeters (mm)"},{"outcome_type":"secondary","measure":"Difference in myocardial velocities between oxygen levels","time_frame":"Through study completion, within 1hour post-induction","description":"Change in displacement over time (millimeters/second)"},{"outcome_type":"secondary","measure":"Difference in myocardial velocity ratio between oxygen levels","time_frame":"Through study completion, within 1hour post-induction","description":"Change in E/A ratio"},{"outcome_type":"secondary","measure":"Difference in peak twist","time_frame":"Through study completion, within 1hour post-induction","description":"Degrees (°)"},{"outcome_type":"secondary","measure":"Difference in peak torsion","time_frame":"Through study completion, within 1hour post-induction","description":"Degrees/centimeter (°/cm)"},{"outcome_type":"secondary","measure":"Difference in ejection fraction (EF)","time_frame":"Through study completion, within 1hour post-induction","description":"Percent (%)"},{"outcome_type":"secondary","measure":"Difference in chamber volumes","time_frame":"Through study completion, within 1hour post-induction","description":"Millilitres (ml)"}]}
{"nct_id":"NCT04848506","start_date":"2021-05-06","phase":"Phase 2","enrollment":54,"brief_title":"CY 6022 is an Open Label Study to Collect Long-term Safety and Tolerability Data for CK-3773274","official_title":"An Open-Label Study of CK-3773274 for Patients With Symptomatic Hypertrophic Cardiomyopathy (HCM) and Left Ventricular Outflow Tract Obstruction","primary_completion_date":"2026-03-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2026-03-31","last_update":"2021-09-08","description":"The purpose of this study is to collect long-term safety and tolerability data for CK-3773274","other_id":"CY 6022","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Completion of a Cytokinetics trial investigating CK-3773274\r\n\r\n          -  LVEF 55% at the Screening Visit\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Has taken any investigational study drug other than CK-3773274 within 30 days prior to\r\n             screening\r\n\r\n          -  Since completion of a previous trial of CK-3773274 has:\r\n\r\n               -  Developed new-onset paroxysmal or permanent atrial fibrillation requiring rhythm\r\n                  restoring treatment (eg, direct-current cardioversion, ablation procedure, or\r\n                  antiarrhythmic therapy) <30 days prior to screening. Patient may re-screen for CY\r\n                  6022 after 30 days if heart rate (HR) <100 bpm and/or rhythm is stable >30 days\r\n\r\n               -  Undergone septal reduction therapy (surgical myectomy or transcatheter alcohol\r\n                  ablation)\r\n\r\n          -  Has current obstructive coronary artery disease (>70% stenosis documented in one or\r\n             more arteries)\r\n\r\n          -  Has moderate or severe aortic valve stenosis\r\n\r\n          -  Had a confirmed LVEF <40% with an associated dose interruption during CY 6021\r\n\r\n          -  Has been treated with drugs that have negative inotropic activity (except for beta-\r\n             blockers, calcium channel blockers, or disopyramide) as monotherapy or in combination\r\n             within 30 days prior to screening. Patients receiving treatment with disopyramide\r\n             require approval from the medical monitor prior to enrollment.\r\n\r\n          -  History of syncope or sustained ventricular tachyarrhythmia with exercise within 30\r\n             days prior to screening\r\n\r\n          -  History of appropriate ICD shock within 30 days prior to screening\r\n\r\n          -  Has received treatment with mavacamten within 3 months prior to screening\r\n      ","sponsor":"Cytokinetics","sponsor_type":"Industry","conditions":"Obstructive Hypertrophic Cardiomyopathy","interventions":[{"intervention_type":"Drug","name":"Drug: CK-3773274 (5 - 15 mg)","description":"CK-3773274 tablets administered orally"}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of adverse events observed during dosing of CK-3773274 in patients with oHCM","time_frame":"To End of study, up to 5 years","description":"Patient incidence of reported Adverse Events (AEs)"},{"outcome_type":"secondary","measure":"Incidence of serious adverse events observed during dosing of CK-3773274 in patients with oHCM","time_frame":"To End of study, up to 5 years","description":"Patient incidence of reported Serious Adverse Events (SAEs)"},{"outcome_type":"secondary","measure":"Incidence of left ventricular ejection fraction (LVEF) < 50% observed during dosing of CK-3773274 in patients with oHCM","time_frame":"To End of study, up to 5 years","description":"Patient incidence of reported LVEF <50%"},{"outcome_type":"secondary","measure":"Long-term effects of CK-3773274 on left ventricular outflow tract gradient (LVOT G)","time_frame":"Baseline through the end of participation at 12-week intervals","description":"Peak LVOT-G at rest"}]}
{"nct_id":"NCT04827732","start_date":"2021-05-04","phase":"N/A","enrollment":20,"brief_title":"Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) in Recurrent Rectal Cancer","official_title":"Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) in the Reirradiation of Locoregionally Recurrent Rectal Cancer - IMPARC","primary_completion_date":"2024-11-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2025-05-31","last_update":"2021-07-22","description":"The purpose of this trial is to determine the maximum tolerated dose (MTD) of hypofractionated IMPT for the reirradiation of locoregionally recurrent rectal cancer.","other_id":"202103218","allocation":"Non-Randomized","intervention_model":"Sequential Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  History of biopsy-proven adenocarcinoma of the rectum, anus or rectosigmoid junction\r\n             of any stage now with recurrent disease in the pelvis\r\n\r\n          -  One prior course of radiation therapy to the pelvis for rectal cancer\r\n\r\n          -  ECOG performance status 0-2\r\n\r\n          -  At least 18 years of age\r\n\r\n          -  Women of childbearing potential and men must agree to use adequate contraception\r\n             (hormonal or barrier method of birth control, abstinence) prior to study entry and for\r\n             the duration of study participation. Should a woman become pregnant or suspect she is\r\n             pregnant while participating in this study, she must inform her treating physician\r\n             immediately.\r\n\r\n          -  Able to understand and willing to sign an IRB-approved written informed consent\r\n             document.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with pre-existing radiosensitizing conditions, such as connective tissue\r\n             disorders (i.e. lupus, scleroderma) and genetic mutations (i.e. ataxia-telangiectasia)\r\n\r\n          -  A history of other malignancy with the exception of malignancies for which all\r\n             treatment was completed at least 2 years before registration and the patient has no\r\n             evidence of disease, basal cell or squamous cell carcinoma of the skin that were\r\n             treated with local resection only, or carcinoma in situ of the cervix. Patients with\r\n             history of prostate cancer treated without radiotherapy and no evidence of disease are\r\n             eligible\r\n\r\n          -  More than one prior course of radiation to the pelvis for rectal cancer\r\n\r\n          -  Prior radiation to the pelvis for disease other than rectal cancer\r\n\r\n          -  Current treatment with any investigational agents.\r\n\r\n          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active\r\n             infection, or unstable angina pectoris\r\n\r\n          -  Pregnant and/or breastfeeding. Women of childbearing potential must have a negative\r\n             urine or serum pregnancy test within 14 days of study entry.\r\n      ","sponsor":"Washington University School of Medicine","sponsor_type":"Other","conditions":"Recurrent Rectal Cancer","interventions":[{"intervention_type":"Radiation","name":"Radiation: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy","description":"When feasible it is strongly recommended that radiotherapy begin on a Monday"},{"intervention_type":"Device","name":"Device: MEVION S250i Hyperscan and Adaptive Aperture Proton Therapy Machine","description":"-The device that will administer the IMPT"}],"outcomes":[{"outcome_type":"primary","measure":"Maximum tolerated dose (MTD) of reirradiation using hypofractionated IMPT","time_frame":"Through 6 months from start of treatment for all participants enrolled (estimated to be 42 months)","description":"MTD is defined as the dose associated with a 35% probability of dose-limiting toxicity (DLT).\r\nDLT is defined as any toxicity listed below that occurs within 6 months from start of treatment and is considered possibly, probably, or definitely related to proton reirradiation:\r\nAny grade 5 toxicities\r\nAny grade 4-5 GI toxicities\r\nBowel obstruction\r\nGrade 3-5: diarrhea; anal, colonic, or bowel ulcers; bladder perforation; any fistula formations; peripheral motor/sensory neuropathy of the pelvis above baseline; osteonecrosis/soft tissue necrosis; radiation dermatitis; hematuria; hematochezia; bowel/pelvic hemorrhage; reproductive tract toxicity\r\nToxicity will be graded using CTCAE v5"},{"outcome_type":"secondary","measure":"Clinical complete response rate","time_frame":"Within 6-8 weeks post-completion of radiation therapy (estimated to be 7-9 weeks)","description":"-DRE, endoscopy, and cross sectional imaging will be used to measure clinical complete response rate"},{"outcome_type":"secondary","measure":"Median freedom from locoregional progression (FFLP)","time_frame":"At 12 months post-radiation therapy (estimated to be 12 months and 1 week)","description":"-Defined as time from end of radiation therapy to date of first local or regional tumor progression"},{"outcome_type":"secondary","measure":"Median overall survival (OS)","time_frame":"At 12 months post-radiation therapy (estimated to be 12 months and 1 week)"},{"outcome_type":"secondary","measure":"Median progression-free survival (PFS)","time_frame":"At 12 months post-radiation therapy (estimated to be 12 months and 1 week)","description":"-Defined as time from end of radiation therapy to the earliest date of locoregional progression, distant progression, or death from any cause"},{"outcome_type":"secondary","measure":"Change in quality of life as measured by the EORTC QLQ-C30","time_frame":"Prior to start of radiation therapy, 1-2 weeks post radiation therapy, 3 months post radiation therapy, 6 months post radiation therapy, 9 months post radiation therapy and 12 months post radiation therapy","description":"-The EORTC QLQ-C30 consists of a 30-question questionnaire, which assesses patient well-being with five functional scales (the physical, role, emotional, cognitive, social, and global). It also includes three symptom scales (fatigue, pain, nausea/vomiting) and six single items (dyspnea, sleep disturbance, appetite loss, diarrhea, constipation, and financial impact). Single-item QL scores for overall physical condition (question 29), overall quality of life (question 30), and the global and social functioning scales have been shown to be prognostic for overall survival in adult patients with advanced malignancies"},{"outcome_type":"secondary","measure":"Change in quality of life as measured by the EORTC QLQ-CR29","time_frame":"Prior to start of radiation therapy, 1-2 weeks post radiation therapy, 3 months post radiation therapy, 6 months post radiation therapy, 9 months post radiation therapy and 12 months post radiation therapy","description":"-The QLQ-CR29 contains 29 questions, including items in 4 scales (urinary frequency, blood/mucus in stools, stool frequency, body image) and 19 single items (urinary incontinence, dysuria, abdominal pain, buttock pain, bloating, dry mouth, hair loss, taste, anxiety, weight, flatulence, fecal incontinence, sore skin, embarrassment, stoma care problems, sexual interest for men, sexual interest for women, impotence, dyspareunia). There are 11 items allocated for specific sub-populations, including males, females, and stoma patients. Scores of the QLQ-CR29 can be linearly transformed to provide a score from 0 to 100, with higher scores representing higher levels of functioning on the functional scales, greater degrees of symptomatology on the symptom scales and improved QOL on the global QOL scale"},{"outcome_type":"secondary","measure":"Frequency of acute adverse events as measured by CTCAE v 5.0","time_frame":"From start of treatment through 3 months after completion of radiation therapy (estimated to be 3 months and 1 week)"},{"outcome_type":"secondary","measure":"Frequency of late adverse events as measured by CTCAE v 5.0","time_frame":"From 3 month post-completion of radiation therapy to 12 months post-completion of radiation therapy"}]}
{"nct_id":"NCT04880733","start_date":"2021-05-03","phase":"N/A","enrollment":165,"brief_title":"Acupuncture in the Emergency Department for Pain Management","official_title":"Acupuncture in the Emergency Department for Pain Management: A BraveNet Multi-Center Feasibility Study","primary_completion_date":"2022-06-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-08-31","last_update":"2021-05-11","description":"Our goal is to use the U01 mechanism to conduct a two-arm multisite, feasibility RCT (Acupuncture vs Usual Care) to refine procedures for conducting a future fully powered multi-site RCT. The effort will be led by the BraveNet Coordinating Center at Einstein and include 3 BraveNet PBRN sites University Hospitals/ Case Western Reserve University (UH/Case), Vanderbilt University Medical Center (VUMC), and University of California-San Diego (UCSD). During Year 1 (Aim 1), we will develop the manualized acupuncture intervention with consensus from experts in the delivery of acupuncture for acute pain. At the end of Year 1 (prior to the start of the RCT), a study investigator meeting will be held to ensure consistent training of all study coordinators and acupuncturists to the study data collection, human subjects, intervention delivery, and reporting requirements. In Year 2-3 (Aim 2), we will enroll 165 participants (55 per site) into the randomized trial (1:1 assignment to Acupuncture or Usual Care) over a ~9-month enrollment period for each site. Sites will participate in the study sequentially, thus general findings from the implementation evaluation may be used to improve implementation at subsequent sites. Treatment outcomes include pain intensity, state anxiety and pain medication utilization within the ED (via EHR data extraction). In Aim 2a, 75 structured qualitative interviews of ED providers, staff, study acupuncturists (~10 per site) and acupuncture patients (~15 per site) and direct observation at each site will be used to identify barriers and facilitators of successful implementation. The Implementation Evaluation includes two broad categories of data: implementation outcomes (collected in Aim 2 as the feasibility study is conducted at each site) and explanatory factors (Aim 2a).","other_id":"U01AT010598-01A1","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients 18 years of age\r\n\r\n          -  Ability to communicate in English.\r\n\r\n          -  Level 3, 4, 5 on triage rate scale\r\n\r\n          -  Presentation with acute non-emergent (musculoskeletal, back, pelvic, non-cardiac\r\n             chest, abdominal, flank or head) pain 4 on a 0-10-point NRS due to non-penetrating\r\n             injury.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Fever exceeding 100 F\r\n\r\n          -  Presenting with a chief complaint of a psychological / psychiatric concern\r\n\r\n          -  Presenting with chief complaint of Migraine\r\n\r\n          -  Patient arriving via ambulance or skipping triage\r\n\r\n          -  Current Pregnancy\r\n\r\n          -  Self-reported opioid medication taken orally within 4 hours\r\n\r\n          -  Presenting with chief complaint of Joint Dislocation\r\n\r\n          -  Presenting with chief complaint of Bone Fracture\r\n\r\n          -  Confirmed or suspected COVID-19\r\n      ","sponsor":"Case Western Reserve University","sponsor_type":"Other","conditions":"Acupuncture|Pain Management|Emergency Department|Acute Pain","interventions":[{"intervention_type":"Procedure","name":"Procedure: Acupuncture for pain management","description":"A manualized acupuncture protocol will be performed by a licensed acupuncturist in the patient's emergency department room."},{"intervention_type":"Other","name":"Other: Usual care for pain managment","description":"Patient will receive usual care for pain managment."}],"outcomes":[{"outcome_type":"primary","measure":"Successful recruitment of eligible participants into the study.","time_frame":"At Enrollment","description":"The recruitment rate (# enrolled / # eligible) will be assessed for the overall study. Separate recruitment rates will be calculated by site"},{"outcome_type":"secondary","measure":"Number of participants retained in the study","time_frame":"Immediately after the acupuncture intervention or usual care (an average of 60 minutes), at the end of individial patient's discharge from the ED (expected average of 2 hours), 1-week and 4-week follow-up assessments","description":"Retained patients will be defined as those providing patient reported outcomes scores (e.g., pain, anxiety) at ED discharge, 1 week and 4-week follow-up assessments. Separate retention rates (# retained / # enrolled) will be assessed overall and by site. Separate retention rates will also be calculated for each of the three timeframes."},{"outcome_type":"secondary","measure":"Proportion of Emergency Department clinical provider's eligible participants that are clinically approved for study participation.","time_frame":"At Enrollment","description":"Patient adoption rates will be defined as the number of approved individuals for inclusion in the study by ED clinical providers (MD, DO, NP, PA) divided by number of individuals who were prescreened for study participation by the research team for enrollment. Rates will be calculated the overall study and by site."},{"outcome_type":"secondary","measure":"Patient acceptability of pain management and treatment within the Emergency Department","time_frame":"Immediately after the acupuncture intervention or usual care (an average of 60 minutes), at the end of individial patient's discharge from the ED (expected average of 2 hours), 1-week and 4-week follow-up assessments","description":"Participants will be asked to rate their satisfaction with how their pain was managed and their satisfaction with assigned treatment at ED discharge. Separate scores will be calculated for the 1 and 4-week follow-up assessments. All enrolled participants will be asked to answer one question: \"How satisfied are you with how your pain was managed during your ED visit\" on the 5-point Likert scale (1-Very Satisfied--5-Strongly Dissatisfied). A second question will be asked only of acupuncture-assigned patients: \"Overall how satisfied are you with the acupuncture treatment you received your ED visit?\" on the same 5-point Likert Scale."},{"outcome_type":"secondary","measure":"Provider satisfaction with acupuncture treatment within the Emergency Department","time_frame":"At end of enrollment period for ED provider's site","description":"ED clinical providers (MD, DO, NP, PA) who had patients enrolled in the study will be asked to rate their general satisfaction with how their patients' pain was managed by acupuncture as part of the study. Providers will answer two questions: \"How satisfied were you with the acupuncture intervention as delivered in your setting?\" and \"To what degree was the acupuncture intervention helpful in managing patient pain in your ED setting?\" (1-Very satisfied/helpful-5-Very dissatisfied/Not at all helpful)."}]}
{"nct_id":"NCT04858503","start_date":"2021-05-01","phase":"N/A","enrollment":268,"brief_title":"An Internet-based Cardiac Rehabilitation Enhancement (i-CARE) Intervention to Support Self-care of Patients With Coronary Artery Disease","official_title":"An Internet-based Cardiac Rehabilitation Enhancement (i-CARE) Intervention to Support Self-care of Patients With Coronary Artery Disease: A Mixed-method Study","primary_completion_date":"2023-06-30","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2023-08-31","last_update":"2021-04-26","description":"This study aims to examine the effects of an internet-based cardica rehabilitation enhancement (i-CARE) programme for coronary artery disease (CAD) patients on self-care behaviour, biomarkers, physiological, anthropometric parameters, clinical outcomes and self-reported health outcomes and to understand why and how i-CARE influences patients' health behaviours.","other_id":"NTWC/REC/20139","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18 years of age\r\n\r\n          -  living in the community,\r\n\r\n          -  own a smartphone with internet access,\r\n\r\n          -  communicable in Cantonese,\r\n\r\n          -  type in Chinese or English,\r\n\r\n          -  with a confirmed diagnosis of CAD.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  enrolled to a structured centre-based or home-based cardiac rehabilitation program,\r\n             (2) psychiatric problems,\r\n\r\n          -  impaired cognitive functioning (i.e. Abbreviated Mental Test 6), and\r\n\r\n          -  terminal disease with life expectancy < 1 year.\r\n      ","sponsor":"The University of Hong Kong","sponsor_type":"Other","conditions":"Coronary Artery Disease","interventions":[{"intervention_type":"Other","name":"Other: internet-based cardiac rehabilitation enhancement intervention","description":"Participants in the intervention group will receive a 12-week i-CARE intervention, which will be designed to cover the core elements of CAD self-care: self-care maintenance, self-care monitoring and self-care management. The intervention will comprise: 1) a single individualized face-to-face session and 2) an internet-based intervention through a mobile application. Various behaviour change techniques will be used to increase the self-efficacy of CAD patients in enacting self-care behaviours."}],"outcomes":[{"outcome_type":"primary","measure":"Self-care behaviour","time_frame":"Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)","description":"the Chinese version of Self-Care of Coronary Heart Disease Inventory (SC-CHDI). This self-reported SC-CHDI (22 items) measures self-care maintenance, self-care management and self-care confidence on a four-point response scale. Each subscale score is transformed to 100 points, with higher scores indicate better self-care for that attribute."},{"outcome_type":"secondary","measure":"Biomarkers: lipid profile","time_frame":"Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)","description":"POCT"},{"outcome_type":"secondary","measure":"Physiological: blood pressure","time_frame":"Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)","description":"Blood pressure measured regularly"},{"outcome_type":"secondary","measure":"Anthropometric: waist-to-height ratio","time_frame":"Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)","description":"Measure waist-to-height ratio"},{"outcome_type":"secondary","measure":"Clinical: Cardiovascular event rates and mortality","time_frame":"Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)","description":"the admissions, cardiovascular event rates and mortality data will be retrieved"},{"outcome_type":"secondary","measure":"Self-reported health outcomes: functional status","time_frame":"Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)","description":"The functional status will be measured with the Chinese version of Seattle Angina Questionnaire. This 19-item questionnaire consists of five subscales, including physical limitation, angina stability, angina frequency, treatment satisfaction and the disease perception. The respondents have to rate on a 1 to 5 or 6 sequentially coded status. The subscale scores are transformed to a scale of 0 to 100, with higher scores indicate higher level of functioning/ satisfaction and fewer limitations."},{"outcome_type":"secondary","measure":"Health-related Quality of life (HRQoL)","time_frame":"Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)","description":"The Chinese version of MacNew will be used to measure disease-specific HRQoL.22 It consists of 27 items measuring HRQoL in three domains (physical, emotional and social). Each item is rated on a 1-7 scale, and a global score is calculated by summing the item scores, a higher score represents better HRQoL."}]}
{"nct_id":"NCT04966429","start_date":"2021-05-01","phase":"Phase 2","enrollment":150,"brief_title":"Safety and Efficacy of Maraviroc in Post-stroke Cognitive Impairment","official_title":"Safety and Efficacy of Maraviroc in Post-stroke Cognitive Impairment","primary_completion_date":"2024-04-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2024-06-30","last_update":"2021-07-19","description":"Hypotheses: 1. Subjects with mild post-stroke cognitive impairment (PSCI) are at risk of developing vascular dementia (VaD). Maraviroc treatment in patients suffering from mild PSCI will halt its progression and improve cognitive outcome by affecting synaptic plasticity. 2. CCR5 inhibition produces an anti-inflammatory and anti-atherogenic effect by lowering macrophage infiltration and adhesion molecules. Thus, PSCI patients treated with Maraviroc will present a better inflammatory profile and a deceleration of carotid atherosclerosis, vs. placebo. Objectives: To investigate the safety and efficacy of Maraviroc 150 mg and 600 mg per day vs. placebo in patients with recent subcortical stroke who experience mild PSCI on progression/improvement of clinical symptoms of post-stroke cognitive impairment, change in disease biomarkers and inflammatory profile. The study will include 150 participants aged 50-86 years treated with Maraviroc 150mg or 600mg per day compared to placebo for 12 months in 3 sites.","other_id":"TASMC-21-HH-0625-CTIL","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":50,"maximum_age":86,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Men and women aged 50 to 86 years;\r\n\r\n          2. Able to fully comprehend and sign an informed consent form;\r\n\r\n          3. Fulfill diagnostic criteria for Mild Cognitive Impairment (MCI), as outlined by Albert\r\n             and colleagues, and indicated by: 1. concern about a change in cognition, in\r\n             comparison with the person's previous level, expressed by the participant, an\r\n             informant who knows the patient well, or an investigator; 2. Montreal Cognitive\r\n             Assessment (MoCA) score lower than or equal to 26; 3. general preservation of\r\n             independence in functional abilities; 4. no dementia.\r\n\r\n          4. Fulfill the diagnostic criteria for PSCI/subcortical vascular cognitive impairment\r\n             that developed after the documented stroke/TIA, as outlined by Skrobot and colleagues.\r\n             This requires the presence of a cognitive syndrome (as defined in Section A below) and\r\n             SVD (as defined in Section B below). Impairment in at least one cognitive domain and\r\n             mild to no impairment in instrumental activities of daily living (IADLs)/activities of\r\n             daily living (ADLs), respectively (independent of the motor/ sensory sequelae of the\r\n             vascular event); A. Cognitive Syndrome defined as: 1. Dysexecutive Syndrome: Some\r\n             impairment in goal formulation, initiation, planning, organizing, sequencing,\r\n             executing, set-shifting and maintenance, or abstracting; 2. Memory Deficit: Some\r\n             impairment in recall, relative intact recognition, less severe forgetting, benefit\r\n             from cues. B. Small Vessel Ischaemic Disease defined as: Evidence of relevant\r\n             cerebrovascular disease by brain imaging (in the last 1-24 months) defined as the\r\n             presence of both: (i) Periventricular and deep WMLs (grading scale >1 on the Fazekas\r\n             score) plus at least one lacunar infarct; and (ii) Absence of cortical and/or\r\n             cortico-sub-cortical non-lacunar territorial infarcts and watershed infarcts,\r\n             indicating large vessel disease, signs of normal pressure hydrocephalus, or other\r\n             specific causes of WML.\r\n\r\n          5. Presence or a history of neurological signs as evidence for cerebrovascular disease at\r\n             least 1 month prior to enrollment.\r\n\r\n          6. Community-dwelling;\r\n\r\n          7. Able to comply with scheduled visits, treatment plan, and other trial procedures;\r\n\r\n          8. Able to walk independently;\r\n\r\n          9. Modified Rankin score <2.\r\n\r\n         10. Willing to have a study partner (see Appendix 1 for definition of study partner)\r\n             throughout the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients diagnosed with dementia or significant cognitive impairment as defined by a\r\n             MoCA score <17 at screening and clinical evaluation excluding diagnosis of dementia,\r\n             or other neurological conditions (multiple sclerosis, Parkinson's disease, epilepsy,\r\n             etc.) that affects cognition and mobility;\r\n\r\n          2. Hemorrhages and cerebral edema (e.g., subarachnoid hemorrhage, intracerebral\r\n             hemorrhage, subdural hematoma, epidural hematoma).\r\n\r\n          3. Patients in a state of coma or with severe disturbance of consciousness, aphasia,\r\n             agnosia, or deafness that subsequently affects expression and communication.\r\n\r\n          4. Significant acute medical illness including: drug overdose, severely disturbed liver,\r\n             kidney or lung function, anemia, hypothyroidism, or uncontrolled diabetes\r\n\r\n          5. Presence of cortical involvement on neurologic examination including aphasia,\r\n             extinsion etc.;\r\n\r\n          6. Diagnosed previously with a genetic cause of VCI (e.g., CADASIL);\r\n\r\n          7. Taking medications that may negatively affect cognitive function;\r\n\r\n          8. Unable to meet the specific scanning requirements of the 3T MRI;\r\n\r\n          9. History of hepatitis or elevated hepatic transaminases or bilirubin; positive serology\r\n             for Hepatitis B or C; positive serology for HIV;\r\n\r\n         10. Serum creatinine over 1.8;\r\n\r\n         11. Subject has a current or past diagnosis of bipolar or related disorders, intellectual\r\n             disability, or cluster b personality disorder (e.g., borderline personality disorder,\r\n             antisocial personality disorder, histrionic personality disorder, and narcissistic\r\n             personality disorder), psychotic disorder, schizophrenia, obsessive-compulsive\r\n             disorder, and substance/alcohol use disorders other than nicotine in the past year\r\n             (including barbiturates, methadone, opiates, cocaine, cannabinoids, and amphetamine/\r\n             methamphetamine).\r\n\r\n         12. Subject has suicidal ideation with intent to act during screening phase or on Day 1,\r\n             or has a history of suicidal behavior within the past year.\r\n\r\n         13. Diagnosis of attention deficit disorder;\r\n\r\n         14. Prolongation of the corrected QT (CTc) interval;\r\n\r\n         15. Use of drugs with possible interactions with Maraviroc.\r\n\r\n         16. Subject has known allergies, hypersensitivity, intolerance, or contraindication to\r\n             Maraviroc or its excipients.\r\n\r\n         17. Subject has received an investigational drug (including investigational vaccines) or\r\n             used an invasive investigational medical device within 60 days before the planned\r\n             first dose of study drug or is currently enrolled in an investigational study.\r\n\r\n         18. Subject has any condition for which, in the opinion of the investigator, participation\r\n             would not be in the best interest of the subject (e.g., compromise the well-being) or\r\n             that could prevent, limit, or confound the protocol-specified assessments.\r\n\r\n         19. Subject has had major surgery, (e.g., requiring general anesthesia) within 2 weeks\r\n             before screening, or will not have fully recovered from surgery, or has surgery\r\n             planned during the time the subject is expected to participate in the study.\r\n\r\n         20. Subject is a woman who is pregnant, breast-feeding, or planning to become pregnant\r\n             while enrolled in this study or within 3 months after the last dose of study drug.\r\n      ","sponsor":"Tel-Aviv Sourasky Medical Center","sponsor_type":"Other","conditions":"Post Stroke Cognitive Impairment","interventions":[{"intervention_type":"Drug","name":"Drug: Maraviroc","description":"Tablets"}],"outcomes":[{"outcome_type":"primary","measure":"To evaluate the efficacy of Maraviroc 150 mg and 600 mg per day compared with placebo on progression/ improvement of clinical symptoms of post-stroke dementia.","time_frame":"12 months"},{"outcome_type":"primary","measure":"To investigate the safety and tolerability of Maraviroc 150 mg and 600 mg per day vs. placebo in patients with recent subcortical stroke who experience mild PSCI.","time_frame":"12 months"},{"outcome_type":"secondary","measure":"To evaluate the efficacy of Maraviroc 150 mg and 600 mg compared with placebo on function.","time_frame":"12 months"},{"outcome_type":"secondary","measure":"To demonstrate the effect of Maraviroc 150 mg and 600 mg compared with placebo on markers of disease over time","time_frame":"12 months"}]}
{"nct_id":"NCT03943849","start_date":"2021-05-01","phase":"N/A","enrollment":30,"brief_title":"The Use of Dental Pulp Tissue as an Autogenous Graft for Ridge Augmentation","official_title":"The Use of Dental Pulp Tissue as an Autogenous Graft for Ridge Augmentation","primary_completion_date":"2022-09-01","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2022-09-01","last_update":"2020-11-09","description":"The purpose of this study is to examine and compare the effects of autogenous dental pulp tissue on bone formation in the extraction sockets as compared to commonly used particulate bone graft. The effects on bone formation will be examined using a wide variety of assays.","other_id":"HSC-DB-18-0873","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  American Society of Anesthesiologists (ASA) Physical Status Classification System ASA\r\n             1 (A normal healthy patient) or ASA 2 (A patient with mild systemic disease)\r\n\r\n          -  never smoker\r\n\r\n          -  patients with planned tooth extraction\r\n\r\n          -  intact extraction sockets\r\n\r\n          -  no medication or antibiotics intake for at least 6 months prior to the procedure\r\n\r\n          -  patients who gave their consent to participate in the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  vulnerable subjects (children, pregnant and lactating women, patients with learning\r\n             disabilities, and prisoners)\r\n\r\n          -  inability to obtain pulp tissue (for example, due to previous endodontic therapy,\r\n             obliterated pulp canals)\r\n      ","sponsor":"The University of Texas Health Science Center, Houston","sponsor_type":"Other","conditions":"Tooth Loss","interventions":[{"intervention_type":"Other","name":"Other: Particulate bone graft","description":"Creos allo.gain allogenic bone particulate mineralized cortical bone will be hydrated and placed in the extraction socket."},{"intervention_type":"Other","name":"Other: Autogenous dental pulp tissue","description":"Dental pulp will be isolated from teeth extracted for non-periodontal reasons chairside, mixed with hydrated particulate bone graft, and then placed in the extraction socket."},{"intervention_type":"Other","name":"Other: Resorbable collagen membrane","description":"After placement of particulate bone graft or particulate bone graft plus autogenous dental pulp tissue, socket will be covered by a resorbable collagen membrane and sutured."},{"intervention_type":"Other","name":"Other: Suture","description":"Resorbable or non-resorbable suture material"}],"outcomes":[{"outcome_type":"secondary","measure":"Expression of osteoblastic marker Bsp assessed by quantitative PCR (qPCR)","time_frame":"4 months after placement of bone graft"},{"outcome_type":"secondary","measure":"Expression of osteoblastic marker BSP assessed by immunostaining using anti-BSP antibody","time_frame":"4 months after placement of bone graft"},{"outcome_type":"primary","measure":"Bone fill as assessed by radiograph","time_frame":"immediately after placement of bone graft"},{"outcome_type":"primary","measure":"Bone fill as assessed by radiograph","time_frame":"2 months after placement of bone graft"},{"outcome_type":"primary","measure":"Bone fill as assessed by radiograph","time_frame":"4 months after placement of bone graft"},{"outcome_type":"secondary","measure":"Extent of mineralization as assessed by von Kossa staining","time_frame":"4 months after placement of bone graft"},{"outcome_type":"secondary","measure":"Extent of mineralization as assessed by Xylenol Orange staining","time_frame":"4 months after placement of bone graft"},{"outcome_type":"secondary","measure":"Expression of osteoblastic marker Bglap assessed by quantitative PCR (qPCR)","time_frame":"4 months after placement of bone graft"},{"outcome_type":"secondary","measure":"Expression of osteoblastic marker BGLAP assessed by immunostaining using anti-BGLAP antibody","time_frame":"4 months after placement of bone graft"},{"outcome_type":"secondary","measure":"Expression of osteoblastic marker Dmp1 assessed by quantitative PCR (qPCR)","time_frame":"4 months after placement of bone graft"},{"outcome_type":"secondary","measure":"Expression of osteoblastic marker DMP1 assessed by immunostaining using anti-DMP1 antibody","time_frame":"4 months after placement of bone graft"},{"outcome_type":"secondary","measure":"Expression of osteoblastic marker Col1a1 assessed by quantitative PCR (qPCR)","time_frame":"4 months after placement of bone graft"},{"outcome_type":"secondary","measure":"Expression of osteoblastic marker Sost assessed by quantitative PCR (qPCR)","time_frame":"4 months after placement of bone graft"}]}
{"nct_id":"NCT04725929","start_date":"2021-04-30","enrollment":160,"brief_title":"Vaginal Progesterone Against a Second Attack of Antepartum Haemorrhage in Placenta Previa Women","official_title":"Vaginal Progesterone as Prophylactic Against a Second Attack of Antepartum.Haemorrhage in Pregnant Women Diagnosed as Placenta Previa","primary_completion_date":"2021-08-31","study_type":"Observational [Patient Registry]","rec_status":"Not yet recruiting","completion_date":"2021-08-31","last_update":"2021-04-20","description":"Placenta praevia is associated with an increased risk of preterm delivery (PTD) especially if associated with bleeding and uterine contractions . In this study we will determine the effect of Progesterone in preventing a second attack of antepartum haemorrhage in pregnant women diagnosed with placenta previa","other_id":"Placenta Previa","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"Female","minimum_age":0.46154,"maximum_age":0.65385,"population":"-  Group I, vaginal Progesterone (Vaginal progesterone \"prontogest 400 MG\") Once Daily\r\n             starting from 24 to 34 weeks of gestation or rectal progesterone if the patient fears\r\n             of taking vaginal or still have bleeding,\r\n\r\n          -  Group II, included placenta praevia patients receivinv placebo","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  o Women diagnosed as placenta previa.\r\n\r\n               -  Women aged 20-40 years, who were pregnant in a single foetus\r\n\r\n               -  Gestational age ranging between 24 and 34 weeks\r\n\r\n               -  Patient had attack of Antepartum Haemorrhage or history of Antepartum Haemorrhage\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  o History of previous PTD\r\n\r\n               -  Polyhydramnios\r\n\r\n               -  Severe attack of bleeding requiring an immediate intervention\r\n\r\n               -  Intrauterine foetal death\r\n      ","sponsor":"Nourhan Ashraf ElSherbiny","sponsor_type":"Other","conditions":"Placenta Previa","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"patient with past history of antepartum haemorrhage will not have a secondary attack","time_frame":"2 weeks","description":"decrease the bleeding"},{"outcome_type":"secondary","measure":"duration between first and secondary attack","time_frame":"2 week","description":"time between primary and secondary attack"}]}
{"nct_id":"NCT04866108","start_date":"2021-04-30","phase":"Phase 2","enrollment":49,"brief_title":"A Phase II Study of Fruquintinib Combined With Capecitabine as First-line Treatment for Advanced Metastatic Colorectal Cancer Unsuitable for Intravenous Chemotherapy","official_title":"A Single Center, Open-labeled, Single Arm Phase II Study of Fruquintinib Combined With Capecitabine as First-line Treatment for Advanced Metastatic Colorectal Cancer Unsuitable for Intravenous Chemotherapy","primary_completion_date":"2024-06-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2024-06-30","last_update":"2021-04-29","description":"This is a single center, open-labeled, single arm phase II study aimed to investigate the efficacy and safety of fruquintinib combined with capecitabine as first-line treatment for advanced metastatic colorectal cancer patients unsuitable for intravenous chemotherapy.","other_id":"HMPL-013-FLAG-C104","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. 18 years old at the time of signing the informed consent;\r\n\r\n          2. Histologically or cytologically confirmed unresectable metastatic colorectal cancer;\r\n\r\n          3. Haven't received systematic therapy after diagnosis of metastatic colorectal cancer;\r\n\r\n          4. Intolerable to standard treatment of oxaliplatin- or irinotecan-based intravenous\r\n             combination therapy;\r\n\r\n          5. At least one measurable lesion(s);\r\n\r\n          6. ECOG PS 0-2;\r\n\r\n          7. Life expectancy3 months;\r\n\r\n          8. Adequate organ and bone marrow functions;\r\n\r\n          9. Women of childbearing age must have a negative pregnancy test within the first day of\r\n             the study, and contraceptive methods should be taken during the study until 6 months\r\n             after the last administration;\r\n\r\n         10. Willingness and able to comply with scheduled visits, treatment plans, laboratory\r\n             tests, and other study procedure.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Previous treatment with VEGFR inhibition;\r\n\r\n          2. Participating in other drug clinical trials within 4 weeks before recruited;\r\n\r\n          3. Have received other systemic anti-tumor therapies within 4 weeks before recruited;\r\n\r\n          4. Non-controlled hypertension after monotherapy, that is, systolic blood pressure >\r\n             140mmHg or diastolic blood pressure > 90mmHg;\r\n\r\n          5. Proteinuria  2+ (1.0g/24hr);\r\n\r\n          6. Clinically significant electrolyte abnormality;\r\n\r\n          7. Clinically significant cardiovascular diseases;\r\n\r\n          8. Thromboembolism or arteriovenous events occurred 6 months before recruited;\r\n\r\n          9. grade 3 bleeding events 4 weeks before recruited;\r\n\r\n         10. Evidence of CNS metastasis;\r\n\r\n         11. Active gastric and duodenal ulcer, ulcerative colitis or uncontrolled hemorrhage in\r\n             GI;\r\n\r\n         12. Active, symptomatic interstitial lung disease causing dyspnea ( grade 2 dyspnea),\r\n             pleural effusion or ascites;\r\n\r\n         13. History of organ transplantation;\r\n\r\n         14. APTT >1.5ULN or INR>1.5;\r\n\r\n         15. History of HIV infection or active hepatitis B / C;\r\n\r\n         16. Allergic to fruquintinib and / or capecitabine;\r\n\r\n         17. Pregnant or lactating women;\r\n\r\n         18. Clinically detectable secondary primary malignancies at the time of enrollment\r\n             (excluding fully treated basal cell carcinoma of the skin or carcinoma in situ of the\r\n             cervix);\r\n\r\n         19. Patients who are not suitable for the study judged by the researchers.\r\n      ","sponsor":"Beijing Friendship Hospital","sponsor_type":"Other","conditions":"Unresectable Metastatic Colorectal Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: fruquintinib plus capecitabine","description":"oral fruquintinib plus capecitabine"}],"outcomes":[{"outcome_type":"primary","measure":"Objective Response Rate (ORR)","time_frame":"From Baseline to primary completion date, about 3 years","description":"ORR according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1"},{"outcome_type":"secondary","measure":"Overall Survival (OS)","time_frame":"From Baseline to primary completion date, about 3 years","description":"OS is determined from the date of treatment to death from any cause or the last follow-up date"},{"outcome_type":"secondary","measure":"Progression Free Survival (PFS)","time_frame":"From Baseline to primary completion date, about 3 years","description":"PFS is determined from the date of treatment to PD or death from any cause"},{"outcome_type":"secondary","measure":"Disease Control Rate (DCR)","time_frame":"From Baseline to primary completion date, about 3 years","description":"DCR according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1"},{"outcome_type":"secondary","measure":"Adverse Events and Serious Adverse Events","time_frame":"From Baseline to primary completion date, about 3 years","description":"Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0."},{"outcome_type":"secondary","measure":"Quality of Life (QoL)","time_frame":"From Baseline to primary completion date, about 3 years","description":"Quality of life is assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30. It will be evaluated at Screening, Tumor Assessment Visit and End of Treatment visit."}]}
{"nct_id":"NCT04811209","start_date":"2021-04-30","enrollment":280,"brief_title":"MCID and PASS for Acute Pain and Quality of Recovery After Orthopedic Surgery","official_title":"Determining the Minimum Clinically Important Difference (MCID) and Patient Acceptable Symptom State (PASS) for Acute Pain and Quality of Recovery After Orthopedic Surgery","primary_completion_date":"2023-04-30","study_type":"Observational","rec_status":"Not yet recruiting","completion_date":"2023-04-30","last_update":"2021-03-23","description":"This study seeks to define what constitutes an MCID and a PASS in patients undergoing a variety of elective major orthopedic surgery.","other_id":"20-6059","observational_model":"Other","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":80,"population":"Study patients will be recruited at Toronto Western Hospital","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adult patients aged 18-80 years\r\n\r\n          -  ASA class I - III\r\n\r\n          -  Primary elective surgery\r\n\r\n          -  unilateral major shoulder surgery e.g., stabilization and arthroplasty procedures:\r\n\r\n          -  unilateral total hip replacement\r\n\r\n          -  unilateral total knee replacement, and\r\n\r\n          -  spinal decompression + fusion involving  2 levels.\r\n\r\n          -  Hospital admission for  24 hours after the surgery\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Inability to give informed consent\r\n\r\n          -  Poor English comprehension\r\n\r\n          -  Psychiatric disorders e.g., dementia\r\n\r\n          -  Known allergies to morphine / hydromorphone\r\n\r\n          -  Chronic substance abuse and use of recreational drugs\r\n\r\n          -  Any medical disorder that impairs accurate and objective completion of questionnaires\r\n      ","sponsor":"University Health Network, Toronto","sponsor_type":"Other","conditions":"Pain Management","interventions":[{"intervention_type":"Other","name":"Other: 1.Baseline Measurements Before Surgery","description":"Baseline demographic data\r\nBaseline physiological variables (blood pressure, heart rate, respiratory rate, oxygen saturation)\r\nBaseline investigations (hemoglobin, coagulation profile, serum electrolytes) if appropriate.\r\nPreoperative pain state using NRS (0-10)\r\nPreoperative functional state using the QoR-15 questionnaire\r\nPain expectation - patients will be asked preoperatively with the question \"In a scale from 0 to 10 (where 0 = no pain and 10 = worst pain imaginable), what do you consider is an acceptable pain score for your first (and second) day after surgery?... Two weeks after surgery?\"\r\nPain castastrophizing scale"},{"intervention_type":"Other","name":"Other: 2.Intraoperative Anesthetic Management","description":"All study patients will be managed per routine clinical practice and institutional standard for the performed surgery."},{"intervention_type":"Other","name":"Other: 3.Postoperative Analgesic Management","description":"postoperative pain will be managed on the ward using a multimodal analgesic regimen as appropriate. This includes:\r\nacetaminophen 650 - 1,000 mg given orally every 6 hours around the clock\r\nNSAIDs e.g., celecoxib or other agents given orally around the clock per clinical guideline; omit if contraindicated or per surgeon's preference\r\nOpioids e.g., hydromorphone 1-2 mg or oxycodone 15-30 mg given orally every 1-2 hours as required by the patient per standard nurse administered analgesic protocol.\r\nIn the event of severe pain refractory to the above treatments, the patient will be offered IV opioid e.g., intermittent doses of 0.2-0.4 mg hydromorphone IV every 10 minutes until pain becomes tolerable"},{"intervention_type":"Other","name":"Other: 4.Postoperative NRS Pain Assessment","description":"Pain assessment using NRS pain scores (0 = no pain and 10 = worst possible pain) will be performed by an independent research staff, starting immediately in the PACU and serially over the first 48 hours after surgery or until hospital discharge."},{"intervention_type":"Other","name":"Other: 5.Postoperative Global Rating Scale (GRS) Pain Assessment","description":"Also, the degree of pain relief after treatment is assessed using a subjective 15-point Global Rating Scale (GRS) as mentioned above (Background). This is performed at the same time of each NRS assessment and a minimum of twice daily"},{"intervention_type":"Other","name":"Other: 6.Postoperative Patient Acceptable Symptom State (PASS) Assessment for Pain","description":"During each NRS pain assessment before or after an analgesic intervention on POD 0, 1 and 2, the patient will also be asked this question- \"\"In your opinion, do you consider your current pain state satisfactory after your operation?\" Patients giving a positive response are considered having an acceptable pain state. The PASS is the 75th centile for the pain NRS score in those with a satisfactory pain state."},{"intervention_type":"Other","name":"Other: 7.Postoperative Quality of Recovery Assessment","description":"The quality of recovery 15 questionnaire (QoR-15) to measure the dimension of quality of recovery will be administered once in the morning of POD 1 and POD 2. The MCID and PASS for QoR are determined in the same way as for NRS score. The final MCID value will be average of 4 values, 1 generated by the anchor based method and 3 generated by the distribution based method. The PASS for QoR is the 75th centile of the QoR-15 score in those patients who rated their recovery as good."},{"intervention_type":"Other","name":"Other: 8.Other Postoperative Assessments","description":"Additionally, opioid related adverse effects e.g., nausea, vomiting, itchiness, constipation, sedation (RASS + Ramsay)/ and respiratory depression will be assessed daily."}],"outcomes":[{"outcome_type":"primary","measure":"MCID for NRS pain score after orthopedic surgery","time_frame":"The first 48 hours after 4 types of major orthopedic","description":"The MCID value represents the change in NRS score after treatment when the patient reports a small improvement of pain relief that corresponds to a GAR score of 2 or 3."},{"outcome_type":"secondary","measure":"The PASS for NRS pain score after orthopedic surgery","time_frame":"The first 48 hours after 4 types of major orthopedic","description":"The PASS for NRS pain score after orthopedic surgery"},{"outcome_type":"secondary","measure":"The amount of opioid consumption required to achieve MCID and PASS","time_frame":"The first 48 h hours 4 types of major orthopedic","description":"The amount of opioid consumption required to achieve MCID and PASS for acute pain after orthopedic surgery."},{"outcome_type":"secondary","measure":"Quality of recovery","time_frame":"The first 2 days after surgery","description":"Quality of recovery as assessed using the QoR-15 questionnaire (0-150), higher score means better recovery"},{"outcome_type":"secondary","measure":"The MCID and PASS for QoR-15","time_frame":"The first 2 days after surgery","description":"The MCID and PASS for QoR-15 (0-150), higher score means better recovery"},{"outcome_type":"secondary","measure":"The incidence of opioid related adverse reactions and treatments required","time_frame":"The first 2 days after surgery","description":"The incidence of opioid related adverse reactions and treatments required"}]}
{"nct_id":"NCT04768504","start_date":"2021-04-30","phase":"Phase 2","enrollment":10,"brief_title":"Tofacitinib for the Treatment of Refractory Immune-related Colitis From Checkpoint Inhibitor Therapy- TRICK Study","official_title":"An Open-label Study of Tofacitinib for the Treatment of Refractory Immune-related Colitis From checKpoint Inhibitor Therapy (TRICK)","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2022-04-30","last_update":"2021-02-24","description":"This is a single-arm pilot study evaluating the efficacy and safety of tofacitinib in cancer patients with immune-related colitis from immune checkpoint inhibitor (ICI) therapy.","other_id":"CR2108KE","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria\r\n\r\n          1. 18 years of age or older.\r\n\r\n          2. Able to provide informed consent.\r\n\r\n          3. Exposure to an immune checkpoint inhibitor (CTLA-4, PD-1, PDL-1) as part of a cancer\r\n             treatment regimen within 6 months of the onset of colitis symptoms. The ICI may be\r\n             used as a single agent, or in combination with other ICIs, or with chemotherapy.\r\n\r\n          4. Current diagnosis of immune-related colitis characterized by grade  2 diarrhea as per\r\n             CTCAE v5.0.\r\n\r\n          5. Patients should have failed corticosteroids (at least 1mg/kg equivalent of prednisone\r\n             for a minimum of 72 hours), and at least one dose of a biologic agent (i.e. either a\r\n             TNF inhibitor or an anti-integrin). Failure is defined as having ongoing grade  2\r\n             diarrhea per CTCAE v5.0.\r\n\r\n          6. Adequate hematological function, defined by:\r\n\r\n               1. hemoglobin  90 g/L\r\n\r\n               2. absolute neutrophil count  1.0 x 109/L\r\n\r\n               3. lymphocyte count  0.5 x 109/L\r\n\r\n               4. platelets  75 x 109/L\r\n\r\n               5. PT, PTT, INR  1.5 x upper limit of normal (ULN).\r\n\r\n          7. Adequate liver function, as assessed by the Child Pugh classification score (appendix\r\n             1). Patients with scores A and B are eligible for enrollment. Patients with severe\r\n             hepatic impairment (Child Pugh C) are excluded from the study.\r\n\r\n          8. Adequate renal function as defined by an estimated clearance  40 mL/min, calculated\r\n             per the Cockroft-Gault formula (appendix 2).\r\n\r\n          9. Women of childbearing potential (WOCBP) are eligible if they agree to use adequate\r\n             contraception while on study.\r\n\r\n        Exclusion criteria\r\n\r\n        Patients should meet none of the following exclusion criteria to be eligible for this\r\n        study:\r\n\r\n          1. Diagnosis of a thromboembolic event (deep vein thrombosis, pulmonary embolism, embolic\r\n             stroke, myocardial infarction, or peripheral arterial insufficiency) within 3 months\r\n             of enrollment.\r\n\r\n          2. Diagnosis of concomitant infectious colitis (e.g. C. Difficile or other bacterial\r\n             source), unless the patient has finished an appropriate length of treatment with\r\n             antibiotics as indicated for each diagnosis at the time of enrollment.\r\n\r\n          3. Any other grade  3 infection at the time of enrollment.\r\n\r\n          4. Prior therapy with a JAK inhibitor within 3 months preceding enrollment.\r\n\r\n          5. Active pregnancy or breastfeeding.\r\n\r\n          6. Patients on intravenous biologic agents for other baseline autoimmune conditions.\r\n\r\n          7. Patients having other concomitant uncontrolled irAEs at the time of enrollment which\r\n             would require systemic corticosteroids or biologic immunomodulatory agents.\r\n      ","sponsor":"Khashayar Esfahani","sponsor_type":"Other","conditions":"Immune-Mediated Colitis","interventions":[{"intervention_type":"Drug","name":"Drug: Tofacitinib 10 mg","description":"Tofacitinib 10 mg PO BID for 30 days"}],"outcomes":[{"outcome_type":"primary","measure":"Clinical Remission of Diarrhea","time_frame":"30 days","description":"Resolution of diarrhea to grade 1 or less per Common Terminology Criteria for Adverse Events"},{"outcome_type":"secondary","measure":"Safety of tofacitinib","time_frame":"30 days","description":"Defined as the occurrence of Grade 3 or higher adverse events"},{"outcome_type":"secondary","measure":"Endoscopic remission","time_frame":"At 8 weeks","description":"per Mayo score of less or equal than 2"}]}
{"nct_id":"NCT04549103","start_date":"2021-04-30","phase":"N/A","enrollment":60,"brief_title":"Effect of Baduanjin on Functional Performance in Pre-Frail/Frail Older Adults","official_title":"Effect of Community-based Baduanjin () on Functional Performance in Pre-Frail/Frail Older Adults: A Randomised Controlled Trial","primary_completion_date":"2022-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-12-31","last_update":"2021-08-12","description":"The aim for this study is to investigate the effectiveness of a 16-week realistic community-delivered Baduanjin training program compared to a waitlist control intervention, in improving functional outcomes among pre-frail and frail older adults in Singapore. It is hypothesized that participants that receive 16-week of BDJ training will have significant improvement in physical function (including balance, muscle strength, and endurance); alleviate exhaustion; reduce risk of falling and fear of falling; potentially reverse frailty; reduce depression; and improve quality of life, potentially with greater improvements in area(s) for individuals with lower baseline measures. Whereas, participants in the waitlist control group, will have insignificant changes to their baseline measures.","other_id":"TCMG BDJ RCT","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","intervention_model_description":"Randomised controlled trail","sampling_method":"","gender":"All","minimum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Pre-frail and frail adults aged 55 years and above\r\n\r\n          -  Able to ambulate (move about) without personal assistance and has no other physical\r\n             limitations affecting participation and adherence\r\n\r\n          -  Able to understand basic instructions\r\n\r\n          -  Generally sedentary lifestyle\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Participating in other intervention studies\r\n\r\n          -  Perform regular moderate to vigorous intensity exercise\r\n\r\n          -  Perform regular Taichi or Qigong exercise\r\n\r\n          -  Have severe audio-visual impairment\r\n\r\n          -  Diagnosed with cognitive impairment (e.g. dementia, Alzheimer's Disease) and/or\r\n             history of neurological disorder (e.g. cerebral palsy, Parkinson's Disease)\r\n\r\n          -  Diagnosed with postural hypotension (have a drop of 20mmHg systolic blood pressure, or\r\n             a drop of 10mmHg diastolic blood pressure within two to five minutes of standing up,\r\n             or if standing causes signs and symptoms)\r\n\r\n          -  Unable to participate for the full duration of the study\r\n\r\n          -  Unable to come to the training site by himself/herself or by the help of caregivers\r\n\r\n          -  Not suitable to participate in exercise as deemed by a medical doctor\r\n      ","sponsor":"Geriatric Education and Research Institute","sponsor_type":"Other","conditions":"Frailty|Frail Elderly Syndrome","interventions":[{"intervention_type":"Other","name":"Other: Baduanjin exercise program","description":"Baduanjin (BDJ), also known as Eight-Section Brocades, is one of the forms of traditional Chinese Qigong exercises, characterized by symmetrical physical posture, movements, mindfulness, and breathing. Its primary focus is on the release of 'Qi' or internal body energy with the intent of improving health outcomes. BDJ encompasses eight simple movements involving combinations of postures, meditation, slow relaxing movements, and breathing exercises. It is a low intensity exercise, which have been found to improve range of motion, strength and general health. The simplicity and low intensity level is ideal for older adults to practice at home using instructional videos."}],"outcomes":[{"outcome_type":"primary","measure":"Change in Knee Extension Strength","time_frame":"Baseline, and after 16-weeks of intervention","description":"Knee extension strength is measured using a digital dynamometer gauge. Prior to performing the test, leg dominant is determined by asking participants which is their dominant leg or which leg they would predominantly use when performing a task. For the assessment, participants will be asked to extend their leg against the spring gauge while seated with the hip and knee joint angles positioned at 90°. Maximal force is recorded in kilograms."},{"outcome_type":"primary","measure":"Change in Maastricht Vital Exhaustion Score (MQ)","time_frame":"Baseline, and after 16-weeks of intervention","description":"Maastricht vital exhaustion score (MQ) is a short questionnaires that requires between 5 to 10 minutes for completion. MQ is a validated tool to assess feelings of \"vital exhaustion\", which has three defining characteristics: (1) feeling of excessive fatigue and lack of energy, (2) increased irritability, and (3) feelings of demoralization."},{"outcome_type":"primary","measure":"Change in Falls Efficacy Scale-International (FES-I)","time_frame":"Baseline, and after 16-weeks of intervention","description":"The Falls Efficacy Scale-International (FES-I) is a short, easy to administer tool that measures the fear of falling in older population during social and physical activities inside and outside the home. The level of concern is measured on a four point Likert scale (1=not at all concerned to 4=very concerned). The 16-item FES-I is a well validated and feasible measure to assess fear of falling in older persons, and predicts future risks of falls."},{"outcome_type":"secondary","measure":"Change in Physiological Profile Assessment. (PPA - Short Form)","time_frame":"Baseline, and after 16-weeks of intervention","description":"Physiological Profile Assessment (PPA) is a valid and reliable measure of balance function and fall risk, is feasible for older adults to undertake, and can quantify changes in specific physical components contributing to falls in response to BDJ training. PPA comprises a series of five sensorimotor assessments: edge contrast sensitivity, lower limb proprioception, knee extension strength, hand reaction time, and postural sway. These five components will be weighted to compute a composite PPA fall risk score: high composite PPA scores indicate high risk of falling."},{"outcome_type":"secondary","measure":"Change in Hand Grip Strength","time_frame":"Baseline, and after 16-weeks of intervention","description":"Hand-grip dynamometer was found to be a valid tool in clinical and research practice, and is an easy, quick, and inexpensive way of assessing HGS in older adults. Prior to performing the hand-grip strength test, hand dominance is determined by asking participants which hand they use for writing or which hand they would predominantly use when performing a task. HGS is measured in kilograms by taking the average of the two dominant handgrip attempts using a Jamar Plus + Digital Hand Dynamometer."},{"outcome_type":"secondary","measure":"Change in 6-meter Fast Gait Speed Test","time_frame":"Baseline, and after 16-weeks of intervention","description":"The purpose of the gait speed test is to measure the participant's fastest speed while walking and mobility. Fast gait speed is determined across a distance of 6 meter, which is marked on the floor with tape. Subjects are allowed to use their usual walking aid. Two trails will be administered, time (in seconds) will be recorded for each trial. The average speed of two trails will be recorded as the fast gait speed."},{"outcome_type":"secondary","measure":"Change in Time Up and Go test (TUG)","time_frame":"Baseline, and after 16-weeks of intervention","description":"Time Up and Go test (TUG) is a reliable and valid test for quantifying functional mobility for frail elder person. The participant is observed and timed while he rises from an arm chair, walks 3 meters, turns, walks back, and sits down again. As the test is quick, and requires no special equipment or training, it is widely used in studies as a physical assessment."},{"outcome_type":"secondary","measure":"Change in 30 seconds Sit-to-stand (STS)","time_frame":"Baseline, and after 16-weeks of intervention","description":"Sit-to-stand (STS) test is a commonly used functional performance measure in clinical research and practice. STS performance is influenced by multiple physiological and psychological processes and represents a particular transfer skill, rather than a proxy measure of lower limb strength. In 30 seconds STS, participants will be asked to rise from the chair as fast as possible with their arms fold across their chest and the number of times they are able to perform sit-to-stand successfully within 30 seconds will be recorded. The performance of this test is suggested to be influenced by factors associated with balance, muscle strength, lower extremity endurance, and mobility as well."},{"outcome_type":"secondary","measure":"Change in Frailty Score","time_frame":"Baseline, and after 16-weeks of intervention","description":"Frailty score of the participants will be assessed based on the five criteria by Fried in the Cardiovascular Health Study (CHS). The five criteria (modified for this pilot study) include: unintentional weight loss >10 lbs (4.5kg) and/or BMI of <18.5 in the last 6 months measured by self-report, weakness measured by knee extension strength, slowness measured by 6-m gait speed, exhaustion measured by questionnaire (SF-12), and physical inactivity measured by LASA Physical Activity Questionnaire. One-point is assign for the presence of each component, and based on the individual's total score, participants are categorized as frail (3-5 points), pre-frail (1-2 points), and robust (0 point). Reduction in frailty during the study is defined as a transition to a lower frailty category from baseline over 3 months."},{"outcome_type":"secondary","measure":"Change in EuroQol-Five Dimensions (EQ-5D)","time_frame":"Baseline, and after 16-weeks of intervention","description":"EQ-5D is one of the most commonly used generic health quality of life (QoL) status measurement, and its good validity and reliability have been reported in various health conditions. In this study, EQ-5D will be used as a standardized instrument for measuring generic health-related QoL."},{"outcome_type":"secondary","measure":"Change in Geriatric Depression Scale (GDS)","time_frame":"Baseline, and after 16-weeks of intervention","description":"GDS is a 30-item self-report assessment used to identify depression in the elderly. One point is assigned to each answer and the cumulative score is rated on a scoring grid. The grid sets a range of 0-9 as \"normal\", 10-19 as \"mildly depressed\", and 20-30 as \"severely depressed\"."}]}
{"nct_id":"NCT04377945","start_date":"2021-04-28","phase":"Phase 2","enrollment":188,"brief_title":"Study in Parkinson's Disease Patients With Dyskinesia With Combinations of JM-010 and Its Individual Components","official_title":"A Randomized, Double-Blind, Placebo-Controlled, Two-Part Study in Parkinson's Disease Patients With Dyskinesia to Assess the Efficacy and Safety/Tolerability of Fixed Dose Combinations of JM-010 and Its Individual Components","primary_completion_date":"2022-12-12","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-12-31","last_update":"2021-05-19","description":"This is a two-part, double-blind, placebo-controlled, randomized, multicenter Phase 2 clinical trial of JM-010 in patients with Parkinson's Disease.","other_id":"BK-JM-201","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Is able to read, understand, and provide written, dated informed consent prior to\r\n             Screening Visit.\r\n\r\n          -  Is male or female, between 18 and 80 years of age at Screening Visit.\r\n\r\n          -  Is diagnosed with idiopathic PD that meets UK Parkinson's Disease Society (UKPDS)\r\n             Brain Bank Clinical Diagnostic Criteria\r\n\r\n          -  Has experienced dyskinesia\r\n\r\n          -  Has stable peak-effect dyskinesia\r\n\r\n          -  Has more than one hour of \"ON\" time with troublesome dyskinesia\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Has undergone surgery for the treatment of PD\r\n\r\n          -  Has a current diagnosis of Substance Use\r\n\r\n          -  Has psychiatric diagnosis of acute psychotic disorder or other psychiatric diagnoses\r\n\r\n          -  Has current seizure disorders requiring treatment with anticonvulsants.\r\n\r\n        Other criteria related to other medical conditions to be referred to the protocol.\r\n      ","sponsor":"Bukwang Pharmaceutical","sponsor_type":"Industry","conditions":"Dyskinesias|Parkinson Disease","interventions":[{"intervention_type":"Drug","name":"Drug: Part 1, JM-010 component Group A","description":"JM-010 component Group A"},{"intervention_type":"Drug","name":"Drug: Part 1, JM-010 component Group B","description":"JM-010 component Group B"},{"intervention_type":"Drug","name":"Drug: Part 1, JM-010 component Group C","description":"JM-010 component Group C"},{"intervention_type":"Drug","name":"Drug: Part 1, Placebo Group","description":"Placebo Group"},{"intervention_type":"Drug","name":"Drug: Part 2, JM-010 combination Group A","description":"JM-010 combination Group A"},{"intervention_type":"Drug","name":"Drug: Part 2, JM-010 combination Group B","description":"JM-010 combination Group B"},{"intervention_type":"Drug","name":"Drug: Part 2, JM-010 component Group C","description":"JM-010 component Group C"},{"intervention_type":"Drug","name":"Drug: Part 2, Placebo Group","description":"Placebo Group"}],"outcomes":[{"outcome_type":"primary","measure":"Unified Dyskinesia Rating Scale (UDysRS)","time_frame":"Week 12","description":"Unified Dyskinesia Rating Scale (Scoring range: 0-104), higher score indicates more severe dyskinesia"},{"outcome_type":"secondary","measure":"Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)","time_frame":"Week 12","description":"Movement Disorder Society Unified Parkinson's Disease Rating Scale (Part III Scoring range: 0-137), higher score indicates more severe motor impairment"}]}
{"nct_id":"NCT04864431","start_date":"2021-04-26","phase":"N/A","enrollment":54,"brief_title":"Vitamin D and Pre Cachexia and Cancer Cachexia in Epithelial Ovarian Cancer","official_title":"The Effect of Vitamin D on Factors Contributing Pre Cachexia and Cachexia, a Study on Epithelial Ovarian Cancer","primary_completion_date":"2022-04-26","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2022-10-31","last_update":"2021-04-28","description":"Several ex vivo, in vitro, and observational studies on various type of cancer shown positive effect of vitamin D. Vitamin D has widely known as immunomodulator property in various diseases. However, it remains limited studies on immunity and cachexia in cancer, particularly in ovarian cancer. This study will investigate the effect of vitamin D in immune response during chemotherapy among epithelial ovarian cancer patients who have a low level of vitamin D and cachexia","other_id":"VitDCaOV","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","intervention_model_description":"Intervention group: vitamin D 2000 IU ; Control group: placebo","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. age 18-60 years old who are newly diagnosed with ovarian cancer based on\r\n             histopathology\r\n\r\n          2. epithelial ovarian cancer stage II-III\r\n\r\n          3. haven't received chemotherapy\r\n\r\n          4. pre-cachexia or cachexia\r\n\r\n          5. level of vitamin D below 30 ng/ml\r\n\r\n          6. no vitamin D allergy\r\n\r\n          7. ability and willingness to understand and provide informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. autoimmune disease\r\n\r\n          2. chronic liver disease\r\n\r\n          3. chronic renal disease\r\n\r\n          4. known had hypercalcemia\r\n\r\n          5. refractory cachexia\r\n      ","sponsor":"Indonesia University","sponsor_type":"Other","conditions":"Epithelial Ovarian Cancer","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Vitamin D","description":"Vitamin D capsules: each capsule contain 2 tablets of vitamin D 1000 IU. One capsule will be taken on day 1 through 180"},{"intervention_type":"Other","name":"Other: Placebo","description":"Placebo capsule: Each capsule contain saccharum lactis. One capsule will be taken on day 1 through 180"}],"outcomes":[{"outcome_type":"primary","measure":"Rate of immune response in participants receiving vitamin D change from baseline as assessed by lymphocyte CD8","time_frame":"6 months","description":"lymphocyte CD8 is measured by flowcytometry"},{"outcome_type":"secondary","measure":"Find the change of vitamin D level","time_frame":"6 month","description":"vitamin D level is measured by Electro-Chemiluminescence Immunoassay (e CLIA). The normal range is 30-100 ng/ml"},{"outcome_type":"secondary","measure":"Find the daily intake of vitamin D from food","time_frame":"1 month","description":"The amount of vitamin D intake from food in one month is analyzed using food frequency questionnaire in microgram unit measurement. To find the daily intake from food is calculated the total intake in 1 month divided by 30 days. Recommended daily allowance of vitamin D intake from food is 15 microgram/day"},{"outcome_type":"secondary","measure":"Find the rate of sun exposure","time_frame":"1 week","description":"sun exposure defined as total duration of sun exposure per day. It assessed using \"sun exposure questionnaire\". It is calculated based on time outdoor multiply by amount of skin exposure (face, hand, arm, leg, sun bathing), added up everyday for one week. The minimum score is 0 and the maximum score is 56. No score is defined as either adequate or inadequate exposure"},{"outcome_type":"secondary","measure":"Effect of vitamin D in lowering inflammation","time_frame":"6 months","description":"defined inflammation as interleukin-6 which is measured by enzyme-linked immunosorbent assay in ng/ml unit measurement. Interleukin-6 increases if the level more than 4 pg/ml"},{"outcome_type":"secondary","measure":"Effect of vitamin D in lowering circulation tumor cells (CTC)","time_frame":"6 months","description":"the number of tumor cells in blood. Positive CTC if there are 5 tumor cells in 7,5 ml of blood"},{"outcome_type":"secondary","measure":"Effect of vitamin D in improving staging of cachexia","time_frame":"6 month","description":"a diagnostic tools for staging cachexia is measured by Cachexia Score (CASCO). The components of CASCO are body weight loss and composition, inflammation/metabolic disturbances, physical performance, anorexia, and quality of life. CASCO score is presented by numerical scale and classified as mild (score 0-25), moderate (26-50), severe (51-75), and terminal (76-100)"}]}
{"nct_id":"NCT04814329","start_date":"2021-04-22","enrollment":18,"brief_title":"Glioblastoma Response Prediction to Apatinib","official_title":"Study on Predicting Response of Recurrent Glioblastoma to Apatinib","primary_completion_date":"2022-09-30","study_type":"Observational","rec_status":"Recruiting","completion_date":"2022-12-31","last_update":"2021-06-24","description":"Anti-angiogenic therapy is an important treatment strategy for recurrent glioblastoma. Our previous study provided evidence for a potential benefit of apatinib, a humanized monoclonal antibody against VEGFR-2, when added to temozolomide chemotherapy in patients with recurrent glioblastoma. Some patients showed durable responses and prolonged survival, with recorded survival times of over 30 months in 6.4% patients. However, a subset of patients progressed in 2 months. There is a strong need to better predict and monitor apatinib treatment response to prevent patients from adverse effects of ineffective therapy. In this study, whole genome sequencing and RNA-sequencing of formalin-fixed, paraffin-embedded tumor materials from the participants who received apatinib and temozolomide treatment will be performed to identify the response biomarkers and patients who may benefit most from apatinib, avoiding unnecessary potential toxicity and cost for those who are unlikely to benefit from the drug.","other_id":"2021ZZLX03","observational_model":"Case-Control","time_perspective":"Retrospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":70,"population":"Neuro-oncology Department, Sanbo Bran Hospital Capital Medical University","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age 18-70 years old\r\n\r\n          2. recurrent glioblastoma\r\n\r\n          3. received apatinib plus temozolomide treatmentresponse and survival data were\r\n             available\r\n\r\n          4. tumor tissues were acquired\r\n\r\n        Exclusion Criteria:\r\n\r\n        -\r\n      ","sponsor":"Beijing Sanbo Brain Hospital","sponsor_type":"Other","conditions":"Glioblastoma","interventions":[{"intervention_type":"Other","name":"Other: genetic characteristic","description":"the underlying genetic characteristics that prodicting response"}],"outcomes":[{"outcome_type":"primary","measure":"genetic outcome","time_frame":"up to 2 years","description":"response prodicting biomarker"}]}
{"nct_id":"NCT04860713","start_date":"2021-04-22","phase":"Phase 4","enrollment":90,"brief_title":"An Efficacy and Safety of Proprietary Formulations of Oral Ketamine + Aspirin in Treatment of Acute","official_title":"An Efficacy and Safety of Proprietary Formulations of Oral Ketamine + Aspirin and Nurtec (Rimegepant) in Adult Patients Presenting to the ED With Acute Headache: Prospective, Randomized, Open-Label, Clinical Trial","primary_completion_date":"2021-11-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-12-31","last_update":"2021-04-28","description":"Headaches affect over 50% of patients annually, with close to 4% of ED visits for headache. Most headaches managed in the ED are benign, with 90% of these headaches classified as tension, migraine, or cluster. At present, the satisfaction with ED treatment of headache is low, and despite the multitude of available medications, the evidence- based treatment options are often quite limited. There are over twenty different types of medications available to the ED clinicians for managing headache, many with different routes of administration (parenteral, intranasal, subcutaneous, and oral). Many of these medications are provided in so-called \"headache cocktail\", which varies based on the physician, institution, and patient preferences.","other_id":"2021-02-03-MMC","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":120,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients age 18 and older\r\n\r\n          -  Acute Headache\r\n\r\n          -  Initial pain score of 5 or more on a standard 11- point (0 to 10) numeric rating\r\n             scale.\r\n\r\n          -  Awake, alert, and oriented to person, place, and time\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  altered mental status,\r\n\r\n          -  allergy to aspirin, ketamine and rimegepant,\r\n\r\n          -  pregnancy and breastfeeding\r\n\r\n          -  unstable vital signs (systolic blood pressure <90 or>180 mm Hg, pulse rate <50 or >150\r\n             beats/ min, and respiration rate <10 or >30 breaths/min)\r\n\r\n          -  inability to provide consent\r\n\r\n          -  consumption of Aspirin or NSAID's within 6 hours of arrival to the ED or acetaminophen\r\n             within 4 hours of arrival\r\n\r\n          -  active PUD\r\n\r\n          -  history of GI Hemorrhage\r\n\r\n          -  history of renal and hepatic insufficiency\r\n\r\n          -  past medical history of alcohol or drug abuse\r\n\r\n          -  schizophrenia\r\n\r\n          -  clinical findings concerning for acute intracranial process, acute infections process\r\n      ","sponsor":"Antonios Likourezos","sponsor_type":"Other","conditions":"Pain","interventions":[{"intervention_type":"Drug","name":"Drug: aspirin and ketamine","description":"Drug: Proprietary oral formulation of 0.85mg/kg of ketamine + 324mg of aspirin"},{"intervention_type":"Drug","name":"Drug: Nurtec (Rimegepant)","description":"Drug: 75 mg of ODT"}],"outcomes":[{"outcome_type":"primary","measure":"Change in Pain score at 60 minutes","time_frame":"60 minutes","description":"Change of pain scores on numeric rating pain scale (NRS) at 60 minutes mark form the baseline. The NRS is an 11 item Likert Scale ranging from 0 (no pain) to 10 (very severe pain) with 5 indicating moderate pain."}]}
{"nct_id":"NCT04840875","start_date":"2021-04-20","phase":"Phase 1","enrollment":20,"brief_title":"Phase I Clinical Trial of Autologous CD7-CAR T Cells in the Treatment of High-risk Acute T-cell Leukemia / Lymphoma","official_title":"Phase I Clinical Trial of Autologous CD7-CAR T Cells in the Treatment of High-risk Acute T-cell Leukemia / Lymphoma","primary_completion_date":"2022-04-20","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2025-04-20","last_update":"2021-07-02","description":"This is a phase 1 clinical trial of autologous CD7-CAR T cells in the treatment of high-risk acute T-cell leukemia / lymphoma. Twenty subjects will be enrolled. Subjects will be pretreated with chemotherapy prior to infusion of CAR T cells: about 3 days before cells transfusion, the patients who planned to reinfuse CAR T cells were treated with fluorodarabine 30 mg/m2( body surface area) and cyclophosphamide 250 mg/m2( body surface area) for 3 days. Then this study will be using a 3+3 dose escalation approach from dose 1 (DL-1): 5105 (20%) to dose 2 (dl-2): 1106 (20%). Below the lowest dose was reinfused at the PI's discretion.","other_id":"BRYY-IIT-LCYJ-2021-004","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        In order to be eligible to participate in this study, an individual must meet all of the\r\n        following criteria:\r\n\r\n          1. Diagnosed as a high-risk acute T-cell leukemia / lymphoma patient with complete\r\n             remission within 3 months and persistent positive of minimal residual disease,\r\n             expressing tumor surface antigen CD7\r\n\r\n          2. Male or female, aged 0-70 years\r\n\r\n          3. No serious allergic constitution\r\n\r\n          4. Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al., 1982) score\r\n             0 to 2\r\n\r\n          5. Have life expectancy of at least 60 days based on investigator's judgement\r\n\r\n          6. CD7 positive in bone marrow or peripheral blood or immunohistochemistry\r\n\r\n          7. Candidates aged 8-70 years need to be sufficiently conscious and able to sign the\r\n             treatment consent form and voluntary consent form. And Pediatric patients under 8\r\n             years old could be recruited after signing an informed consent form by a legal\r\n             surrogate (Guardian)\r\n\r\n          8. Minimal residual disease was positive after chemotherapy and there were\r\n             contraindications of allogeneic hematopoietic stem cell transplantation.\r\n\r\n        Exclusion Criteria:\r\n\r\n        An individual who meets any of the following criteria will be excluded from participation\r\n        in this study:\r\n\r\n          1. Intracranial hypertension or disorder of consciousness\r\n\r\n          2. Symptomatic heart failure or severe arrhythmia\r\n\r\n          3. Symptoms of severe respiratory failure\r\n\r\n          4. Complicated with other types of malignant tumors\r\n\r\n          5. Diffuse intravascular coagulation\r\n\r\n          6. Serum creatinine and / or blood urea nitrogen  1.5 times of the normal value\r\n\r\n          7. Suffering from septicemia or other uncontrollable infections\r\n\r\n          8. Patients with uncontrollable diabetes\r\n\r\n          9. Severe mental disorders\r\n\r\n         10. Obvious and active intracranial lesions were detected by cranial magnetic resonance\r\n             imaging (MRI)\r\n\r\n         11. Have received organ transplantation (excluding hematopoietic stem cell\r\n             transplantation);\r\n\r\n         12. Reproductive-aged female patients with positive blood HCG test\r\n\r\n         13. Screened to be positive of infection of hepatitis (including hepatitis B and C), AIDS\r\n             or syphilis\r\n      ","sponsor":"Beijing Boren Hospital","sponsor_type":"Other","conditions":"T Cell Lymphoma|T-cell Leukemia","interventions":[{"intervention_type":"Biological","name":"Biological: chimeric antigen receptor T cell treatment","description":"Subjects will be pretreated with chemotherapy prior to infusion of CAR T cells: about 3 days before cells transfusion, the patients who planned to reinfuse CAR T cells were treated with fluorodarabine 30 mg/m2( body surface area) and cyclophosphamide 250 mg/m2( body surface area) for 3 days. Then this study will be using a 3+3 dose escalation approach from dose 1 (DL-1): 5105 (20%) to dose 2 (dl-2): 1106 (20%). Below the lowest dose was reinfused at the PI's discretion."}],"outcomes":[{"outcome_type":"primary","measure":"CR rate","time_frame":"Time Frame: 1 month","description":"The complete remission(CR) rate to the CAR-T treatment"}]}
{"nct_id":"NCT04754308","start_date":"2021-04-19","phase":"N/A","enrollment":511,"brief_title":"COPD and Socially Vulnerable Individuals","official_title":"A Study of the Incidence and Treatment of Impaired Lung Function in Patients Constituting the Target Group of Social Nurses","primary_completion_date":"2026-09-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2026-09-01","last_update":"2021-08-31","description":"The trial investigates and describes the prevalence of COPD in patients who are in the social nurses' target group and investigates the effect of opportunistic screening for COPD in these vulnerable patients. The study population is patients who have been referred to a social nurse at hospitals in the Capital Region, Central Denmark Region and Region Zealand of Denmark during the inclusion period, and monitor them for up to 5 years in order to investigate variables that are significant in terms of the patients' treatment, hospitalisations, and mortality in relation to COPD. Our hypothesis is that there will be a higher incidence of COPD among those patients with whom the social nurses have contact than in the general population.","other_id":"H-20031386","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Screening","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18 years or older\r\n\r\n          -  Able to speak and understand Danish to such an extent that informed consent can be\r\n             obtained\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Not having a Danish civil registration number, since foreign patients do not have free\r\n             access to examinations and medical treatment, and cannot be followed up in the\r\n             national patient registry\r\n      ","sponsor":"Hvidovre University Hospital","sponsor_type":"Other","conditions":"COPD","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Spirometry","description":"The method of examination, Spirometry, is non-invasive (i.e. not an intervention that involves penetration into the body by means of incisions or injections.). It is a routine examination and there are no risks, adverse reactions, or discomforts associated with the examination."}],"outcomes":[{"outcome_type":"primary","measure":"Prevalence of obstructive lung function reduction in patients in the social nurses' target group","time_frame":"Baseline"},{"outcome_type":"primary","measure":"Distribution of diagnosed and undiagnoses COPD in patients","time_frame":"Baseline"},{"outcome_type":"primary","measure":"Numbers of patients diagnosed with obstructive lung function that are subsequently examined at a pulmonary medicine outpatient clinic/GP","time_frame":"Baseline"},{"outcome_type":"primary","measure":"Prevalence of patients diagnosed with COPD after screening","time_frame":"Baseline"},{"outcome_type":"primary","measure":"Does opportunistic screening by social nurses impact on the number of hospital visits?","time_frame":"Follow-up 5 years from inclusion","description":"The outcome is number of outpatient and acute visits with a-diagnosis related to COPD for 3 groups of patients: The group with undiagnosed COPD at inclusion who were investigated, and the group with undiagnosed COPD at inclusion who did not want investigation compared with the group of patients with already diagnosed COPD at inclusion (control group)."},{"outcome_type":"primary","measure":"Does opportunistic screening by social nurses affect medication consumption in connection with the treatment of COPD?","time_frame":"Follow-up 5 years from inclusion","description":"The outcome is redeemed prescriptions for COPD medication among the 2 groups of patients: The group with undiagnosed COPD at inclusion compared with the group of patients with already diagnosed COPD at inclusion (control group)."},{"outcome_type":"secondary","measure":"Prevalence of patients who smoke and wish to stop smoking","time_frame":"Baseline"},{"outcome_type":"secondary","measure":"Prevalence of patients with impaired lung function who have a desire to stop smoking","time_frame":"Baseline"},{"outcome_type":"secondary","measure":"Prevalence of patients who want to quit smoking and accept the smoking cessation offers.","time_frame":"Baseline"}]}
{"nct_id":"NCT04831710","start_date":"2021-04-15","phase":"Phase 2","enrollment":83,"brief_title":"Sintilimab in Combination With Chidamide in Refractory and Relapsed AITL","official_title":"Safety and Efficacy of Sintilimab(S) in Combination With Histone Deacetylase Inhibitor (Chidamide, C) in Refractory and Relapsed (R) Angioimmunoblastic T-cell Lymphoma (AT): A Single-arm, Multicenter Phase II Study(SCRAT)","primary_completion_date":"2022-04-15","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2023-04-15","last_update":"2021-04-05","description":"Angioimmunoblastic T-cell lymphoma (AITL) belongs to a subtype of peripheral T-cell lymphoma (PTCL) and is also a distinct type of non-Hodgkin lymphoma (NHL). The clinical outcomes of AITL is poor and optimal treatment strategies for AITL have not been fully defined. Patients with disseminated or relapsed disease have a very poor outcome, and there is no standard management for relapsed or refractory disease. Epigenetic drugs have been widely used to treat patients with refractory/relapse AITL. Several phase II clinical trails demonstrated the ORR of 33-50% in patients with r/r AITL treated with HDAC inhibitors (including Belimastat, Romidepsin, Chidamide). HDAC inhibitors are important drugs for the current treatment of AITL, but still more than half of the patients can not benefit from it. PD1/PD-L1 blockade was a potent strategy for r/r PTCL in two small sample studies. Current studies have found that HDACi can upregulate the expression of PDL1, In vivo testing of C57BL/6 mice revealed a synergistic tumor suppression after combining HDACi and PD-1 blockade. We carried out a single, open-label, multicenter clinical trial enrolled patients with relapsed/refractory AITL to investigate the safety and efficacy of sintilimab in combination with chidamide.","other_id":"SCRAT","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Volunteer to participate in clinical research; fully understand and know the research\r\n             and sign the Informed Consent Form (ICF); willing to follow and have the ability to\r\n             complete all trial procedures;\r\n\r\n          2. Aged 18-75 years old male or female;\r\n\r\n          3. Angioimmunoblastic T-cell lymphoma confirmed by histopathology examination;\r\n\r\n          4. Paraffin tissue specimens or fresh puncture tissue specimens are available;\r\n\r\n          5. Patients with refractory or relapsed angioimmunoblastic T-cell lymphoma after\r\n             anthracycline-contained regimen treatment. Refractory is defined as: patients did not\r\n             get partial remission (PR) or better responses after first line treatment or disease\r\n             progression within 6 months of the last protocol;\r\n\r\n          6. Eastern cooperative oncology group score: 0-1;\r\n\r\n          7. Estimated survival  3 months;\r\n\r\n          8. There must be at least one evaluate able or measurable lesion that meets the RECIL\r\n             2017 Lymphoma criteria [evaluable lesion: 18Ffluorodeoxyglucose/ Positron Emission\r\n             Tomography (18FDG/PET) examination showing increased lymph node or extranodal uptake\r\n             (higher than liver) and PET and/or computed tomography (Computed Tomography) CT)\r\n             features are consistent with lymphoma findings; lesions can be measured: nodular\r\n             lesions > 15mm or extranodal lesions > 10mm (if the only measurable lesion has\r\n             received radiotherapy in the past, there must be evidence of radiological progress\r\n             after radiotherapy), and accompanied by increased 18FDG uptake). Except for this,\r\n             there is no measurable increase in diffuse 18FDG uptake in the liver;\r\n\r\n          9. Adequate organ and bone marrow function, no severe hematopoietic dysfunction, cardiac,\r\n             pulmonary, liver, kidney, thyroid dysfunction and immune deficiency (no blood\r\n             transfusion, granulocyte colony stimulating factor or other medical support was\r\n             received within 14 days prior to the use of the research drug): 1) The absolute value\r\n             of neutrophils (>1.010^9/L); 2) platelet count (> 7510^9/L); 3) Hemoglobin (> 9 g/\r\n             dL); 4) Upper Limit Normal (ULN) or creatinine clearance rate (>40 mL/ min) of serum\r\n             creatinine (<1.5 times normal value upper limit) (estimated by Cockcroft-Gault\r\n             formula); 5) Serum total bilirubin < 1.5 times ULN; 6) Aspartate Aminotransferase\r\n             (AST), Alanine Aminotransferase (ALT) = 2.5 times ULN; 7) Coagulation function:\r\n             International Normalized Ratio (INR) = 1.5 times ULN; Prothrombin Time (PT), Activated\r\n             Partial Thromboplastin Time (APTT) = 1.5 times ULN (unless the subject is receiving\r\n             anticoagulant therapy and PT and APTT are using anticoagulant therapy at screening\r\n             time). Within the expected range; 8) Thyrotropin (TSH) or free thyroxine (FT4) or free\r\n             triiodothyronine (FT3) were all within the normal range (+10%);\r\n\r\n         10. There was no evidence that subjects had difficulty breathing at rest, and the measured\r\n             value of pulse oximetry at rest was more than 92%;\r\n\r\n         11. Participants must pass a pulmonary function test (PFT) to confirm that forced\r\n             expiratory volume (FEV1)/forced vital capacity (FVC) in the first second is more than\r\n             60%, unless it is a large mediastinal mass caused by lymphoma that cannot meet this\r\n             standard; carbon monoxide diffusion (DLCO), FEV1 and FVC are all above 50% of the\r\n             predicted value; all PFT results must be obtained within four weeks before the first\r\n             administration;\r\n\r\n         12. Subjects who have received antineoplastic therapy should be admitted to the group only\r\n             after the toxicity of the previous treatment has returned to the level of Common\r\n             Terminology Criteria for Adverse Events (CTCAE) V5.0 grade score < 1 or baseline\r\n             level; the level 2 toxicity caused by previous antineoplastic treatment is\r\n             irreversible and is not expected to deteriorate during the study period. (e.g.\r\n             thrombocytopenia, anemia, neurotoxicity, alopecia and hearing loss) can be enrolled\r\n             with the consent of the researchers;\r\n\r\n         13. Women of Childbearing Potential (WOBCP) must undergo a serum pregnancy test within\r\n             seven days before the first medication and the results are negative. WOBCP or men and\r\n             their WOBCP partners should agree to take effective contraceptive measures from the\r\n             signing of ICF until six months after the last dose of the research drug is used.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Hemophagocytic syndrome;\r\n\r\n          2. Primary central nervous system lymphoma or secondary central nervous system\r\n             involvement;\r\n\r\n          3. Received organ transplantation in the past;\r\n\r\n          4. Patients who received allogeneic hematopoietic stem cell transplantation within three\r\n             years before the drug was given (patients who received allogeneic hematopoietic stem\r\n             cell transplantation more than three years before the drug was given and who currently\r\n             have no graft-versus-host response can be enrolled);\r\n\r\n          5. Participating in other clinical studies or planning to start this study is less than 4\r\n             weeks from the end of the previous clinical study;\r\n\r\n          6. Autologous hematopoietic stem cell transplantation was performed within 90 days before\r\n             the start of the study;\r\n\r\n          7. Treated with immune checkpoint inhibitors or histone deacetylase inhibitors within one\r\n             year before administration;\r\n\r\n          8. Patients with active autoimmune diseases requiring systematic treatment in the past\r\n             two years (hormone replacement therapy is not considered systematic treatment, such as\r\n             type I diabetes mellitus, hypothyroidism requiring only thyroxine replacement therapy,\r\n             adrenocortical dysfunction or pituitary dysfunction requiring only physiological doses\r\n             of glucocorticoid replacement therapy); Patients with autoimmune diseases who do not\r\n             require systematic treatment within two years can be enrolled;\r\n\r\n          9. Begin the study on subjects requiring systemic glucocorticoid therapy or other\r\n             immunosuppressive therapy for a given condition within 14 days before treatment\r\n             [allowing subjects to use local, ocular, intra-articular, intranasal and inhaled\r\n             glucocorticoid therapy (with very low systemic absorption); and allowing short-term (<\r\n             7 days) glucocorticoid prophylaxis (e.g., contrast agent overdose) Sensitivity) or for\r\n             the treatment of non-autoimmune diseases (e.g. delayed hypersensitivity caused by\r\n             contact allergens);\r\n\r\n         10. In the past five years, patients with other malignant tumors have undergone radical\r\n             treatment, except for basal cell carcinoma of skin, squamous cell carcinoma of skin,\r\n             carcinoma in situ of breast and carcinoma in situ of cervix.\r\n\r\n         11. Begin the study and receive systemic antineoplastic therapy within 28 days before\r\n             treatment, including chemotherapy, immunotherapy, biotherapy (cancer vaccine,\r\n             cytokines, or growth factors that control cancer), etc.;\r\n\r\n         12. The study began with major surgery within 28 days before treatment or radiotherapy\r\n             within 90 days before treatment;\r\n\r\n         13. Start the study and receive Chinese herbal medicine or Chinese patent medicine\r\n             treatment within 7 days before treatment;\r\n\r\n         14. Begin research on live vaccination (except influenza attenuated vaccine) within 28\r\n             days before treatment;\r\n\r\n         15. History of human immunodeficiency virus (HIV) infection and/or patients with acquired\r\n             immunodeficiency syndrome are known;\r\n\r\n         16. Patients with active hepatitis B or active hepatitis C. Patients who are positive for\r\n             hepatitis B Surface Antigen (HBsAg) or hepatitis C Virus (HCV) antibodies at screening\r\n             stage must pass further detection of hepatitis B Virus (HBV) DNA titer (no more than\r\n             2500 copies/mL or 500 IU/mL) and HCV RNA (no more than the lower limit of the\r\n             detection method) in the row. In addition to active hepatitis B or hepatitis C\r\n             infections requiring treatment, group trials can be conducted. Hepatitis B carriers,\r\n             stable hepatitis B (DNA titer should not be higher than 2500 copies/mL or 500 IU/mL)\r\n             after drug treatment, and cured hepatitis C patients can be enrolled in the group;\r\n\r\n         17. Patients with active pulmonary tuberculosis;\r\n\r\n         18. Start studying any active infections requiring systemic anti-infective treatment\r\n             within 14 days of treatment.\r\n\r\n         19. Pregnant or lactating women;\r\n\r\n         20. People with known history of alcoholism or drug abuse;\r\n\r\n         21. Have uncontrollable complications, including but not limited to symptomatic congestive\r\n             heart failure, uncontrollable hypertension, unstable angina, active peptic ulcer or\r\n             hemorrhagic diseases;\r\n\r\n         22. History of interstitial lung disease or non-infectious pneumonia. Subjects who had\r\n             previously had non-infectious pneumonia caused by drugs or radiation but had no\r\n             symptoms were allowed to enter the group;\r\n\r\n         23. The QTcF interval is more than 450 msec, unless it is secondary to bundle branch\r\n             block;\r\n\r\n         24. Past psychiatric history; incapacitated or restricted;\r\n\r\n         25. According to the researchers' judgment, patients' underlying condition may increase\r\n             their risk of receiving research drug treatment, or confuse their judgment on toxic\r\n             reactions;\r\n\r\n         26. Other researchers consider it unsuitable for patients to participate in this study\r\n      ","sponsor":"Sun Yat-sen University","sponsor_type":"Other","conditions":"Angioimmunoblastic T-cell Lymphoma","interventions":[{"intervention_type":"Drug","name":"Drug: Sintilimab","description":"Sintilimab,200mg, ivd, d1"},{"intervention_type":"Drug","name":"Drug: Chidamide","description":"Chidamide,30mg,po,biw,d1-21"}],"outcomes":[{"outcome_type":"primary","measure":"Objective response rate (ORR), complete response rate (CRR), partial response rate (PRR)","time_frame":"Up to 24 months","description":"Assessed by the RECIL 2017 Response Criteria for Malignant Lymphoma"},{"outcome_type":"secondary","measure":"Progression-Free Survival (PFS)","time_frame":"Up to 24 months","description":"PFS is defined as the time from the treatment date to the date of disease progression per the RECIL 2017 Response Criteria for Malignant Lymphoma or death regardless of cause."},{"outcome_type":"secondary","measure":"Overall Survival (OS)","time_frame":"Up to 24 months","description":"OS is defined as the time from treatment to the date of death."},{"outcome_type":"secondary","measure":"Duration of Response (DOR)","time_frame":"Up to 24 months","description":"Among participants who experience an objective response, DOR is defined as the date of their first objective response (which is subsequently confirmed) to disease progression per the RECIL 2017 Response Criteria for Malignant Lymphoma or death regardless of cause."},{"outcome_type":"secondary","measure":"Time to disease response (TTR)","time_frame":"Up to 24 months","description":"Among participants who experience an objective response, TTR is defined as the date of their first administration to the day of their first objective response (which is subsequently confirmed) per the RECIL 2017 Response Criteria for Malignant Lymphoma."},{"outcome_type":"secondary","measure":"Time to progression (TTP)","time_frame":"Up to 24 months","description":"Among all participants, TTP is defined as the date of their first administration to the day of disease progression per the RECIL 2017 Response Criteria for Malignant Lymphoma or death regardless of cause."},{"outcome_type":"secondary","measure":"The frequency of adverse events (adverse events, AEs) and serious adverse events (SAEs)","time_frame":"Up to 24 months","description":"An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAE were defined as AEs with onset during the treatment period or that are a consequence of a pre-existing condition that has worsened since baseline."}]}
{"nct_id":"NCT04648319","start_date":"2021-04-15","phase":"Phase 2","enrollment":40,"brief_title":"A Study of BMS-936558 With SBRT After Induction Chemotherapy in Cholangiocarcinoma","official_title":"A Pilot Study of BMS-936558 With Stereotactic Ablative Radiation Therapy After Induction Chemotherapy in Cholangiocarcinoma","primary_completion_date":"2023-08-15","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2024-11-15","last_update":"2021-07-23","description":"This is an Open-label, single-arm, multicenter Phase II pilot study to assess the efficacy and safety of BMS-936558 with stereotactic ablative radiation therapy after induction chemotherapy in cholangiocarcinoma.","other_id":"BIO-2019-0447","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"single group assignment","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Inclusion criteria:\r\n\r\n               1. Signed and dated informed consent form.\r\n\r\n               2. Patients aged 18 years.\r\n\r\n               3. Pathologically (histologically or cytologically) and radiologically confirmed\r\n                  diagnosis of non-resectable locally advanced or metastatic or recurrent\r\n                  intrahepatic or extrahepatic CCA within 90 days of registration.\r\n\r\n               4. Patients who have stable disease or partial response following 4 cycles of\r\n                  cisplatin/gemcitabine.\r\n\r\n               5. ECOG performance score <3\r\n\r\n                  o An estimated life expectancy of more than 3 months.\r\n\r\n               6. Have adequate hematologic and biochemical function by meeting the following:\r\n\r\n                    -  Total bilirubin acceptable level  1.5  the institutional upper limit of\r\n                       normal (ULN) range;\r\n\r\n                    -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)\r\n                       acceptable levels up to 5 x ULN range;\r\n\r\n                    -  Serum urea and serum creatinine acceptable levels up to 1.5 x ULN range;\r\n\r\n                    -  Calculated glomerular filtration rate  45 mL/min according to the Chronic\r\n                       Kidney Disease Epidemiology Collaboration equation (or local institutional\r\n                       standard method).\r\n\r\n               7. Negative serum or urine pregnancy test at screening for women of childbearing\r\n                  potential who are sexually active.\r\n\r\n               8. Highly effective contraception for both males and females of child-bearing\r\n                  potential who are sexually active throughout the study and for at least 5 months\r\n                  and 7 months after the last BMS-936558 treatment administration, respectively.\r\n\r\n               9. Candidate for percutaneous biopsy as per tumor location evidenced by CT scan and\r\n                  interventional radiologist.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients who have progression following 4 cycles of cisplatin/gemcitabine evidenced by\r\n             CT scan as per RECIST 1.1.\r\n\r\n          2. Active brain metastases or leptomeningeal metastases.\r\n\r\n          3. Prior organ transplantation or allogenic stem-cell transplantation.\r\n\r\n          4. Known prior severe hypersensitivity to IMP or any component in its formulations,\r\n             including known severe hypersensitivity reactions to monoclonal antibodies (NCI-CTCAE\r\n             v4.03 Grade  3).\r\n\r\n          5. Active infection requiring systemic therapy within 28 days before the first dose of\r\n             study treatment (e.g., urinary tract infection).\r\n\r\n          6. Known history of testing positive for the human immunodeficiency virus or known\r\n             acquired immunodeficiency syndrome.\r\n\r\n          7. Evidence of liver cirrhosis.\r\n\r\n          8. Current use of immunosuppressive medication, except for the following:\r\n\r\n               -  Intranasal, inhaled, topical steroids, or local steroid injection (e.g.,\r\n                  intra-articular injection);\r\n\r\n               -  Systemic corticosteroids at physiologic doses  10 mg/day of prednisone or\r\n                  equivalent;\r\n\r\n               -  Steroids as premedication for hypersensitivity reactions (e.g., CT scan\r\n                  premedication).\r\n\r\n          9. Active autoimmune diseases that might deteriorate upon receiving an immune-stimulatory\r\n             agent.\r\n\r\n         10. Conditions such as vitiligo, psoriasis, diabetes type I, or hypo- or hyper-thyroid\r\n             diseases not requiring immunosuppressive treatment are eligible.\r\n\r\n         11. Commonly excluded conditions include: Addison's disease, thyroiditis/Hashimoto's\r\n             thyroiditis, systemic lupus erythematosus, Sjogren's syndrome, scleroderma, myasthenia\r\n             gravis, Goodpasture's syndrome, and Grave's disease\r\n\r\n         12. Hepatic insufficiency manifesting as clinical jaundice, hepatic encephalopathy, and/or\r\n             variceal bleed within 60 days prior to study entry.\r\n\r\n         13. Transmural myocardial infarction within 6 months of enrollment; provided that\r\n             anti-platelets cannot be stopped to perform percutaneous biopsy.\r\n\r\n         14. Congestive heart failure ( New York Heart Association Classification Class II)\r\n             requiring hospitalization within the last 6 months provided that anti-platelets cannot\r\n             be stopped to perform percutaneous biopsy.\r\n\r\n         15. Serious cardiac arrhythmia requiring medical treatment provided that anti-platelets\r\n             cannot be stopped to perform percutaneous biopsy.\r\n\r\n         16. Recent cerebral vascular accident/stroke within 6 months of enrollment provided that\r\n             anti-platelets cannot be stopped to perform percutaneous biopsy.\r\n\r\n         17. End-stage renal disease requiring dialysis.\r\n\r\n         18. Other severe acute or chronic medical conditions including immune colitis,\r\n             inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis, or psychiatric\r\n             conditions including recent (within the past year) or active suicidal ideation or\r\n             behavior.\r\n\r\n         19. Vaccination within 4 weeks of the first dose of BMS-936558 and while on trial is\r\n             prohibited except for administration of inactivated vaccines.\r\n\r\n         20. Treatment with an investigational agent within 28 days before the first dose of study\r\n             treatment.\r\n\r\n         21. Prior treatment with any drug or antibody (anti-PD-1, anti-PD-L1, anti-PD-L2,\r\n             anti-CD137, or anti-CTLA-4 antibody) targeting T cell co-stimulation or checkpoint\r\n             pathways.\r\n\r\n         22. Patients suspected by the physician that he/she will not be compliant to the protocol\r\n             conduct.\r\n\r\n         23. Pregnant women are excluded from this study; breastfeeding should be discontinued.\r\n\r\n         24. Patients participating in another clinical trial.\r\n\r\n         25. Patients not willing to sign the consent form.\r\n\r\n         26. Any psychiatric condition that would prohibit the understanding or rendering of\r\n             informed consent.\r\n\r\n         27. Legal incapacity or limited legal capacity patients receiving other oncology specific\r\n             medication not authorized in the protocol.\r\n      ","sponsor":"American University of Beirut Medical Center","sponsor_type":"Other","conditions":"Cholangiocarcinoma","interventions":[{"intervention_type":"Drug","name":"Drug: BMS-936558","description":"BMS-936558 followed by 30 grays of 3 to 5 fractions of high dose SBRT followed by monthly BMS-936558 until progression"}],"outcomes":[{"outcome_type":"primary","measure":"To evaluate the progression-free survival (PFS) at 8 months and the disease control rate (DCR) in patients with non-resectable locally-advanced or metastatic or recurrent intrahepatic or extrahepatic CCA following BMS-936558/SBRT treatment","time_frame":"8 months","description":"will be done at 8 months of the initial patient diagnosis and after 8 cycles of treatment"},{"outcome_type":"secondary","measure":"To evaluate the overall survival (OS) rate in patients with advanced intrahepatic or extrahepatic CCA following BMS-936558/SBRT treatment.","time_frame":"up to 2 years","description":"survival status will be evaluated every 3 months after progression"},{"outcome_type":"secondary","measure":"To evaluate tumor response rates at the primary and secondary sites using the response evaluation criteria in solid tumors (RECIST1.1) criteria.","time_frame":"every 4 months from the date of first treatment visit until the date of first documented progression, assessed up to 2 years.","description":"evaluation will be done by CT scan of chest ,abdomen and pelvis every 4 months from the D1 ( after each 4 cycles of treatment until progression )"},{"outcome_type":"secondary","measure":"To evaluate the duration of response at non-irradiated tumor sites in patients with Stage IV disease.","time_frame":"every 4 months from the date of first treatment visit until the date of first documented progression, assessed up to 2 years.","description":"evaluation will be done by CT scan of abdomen, pelvis and chest every 4 months (after every 4 cycles of treatment until progression )"},{"outcome_type":"secondary","measure":"To evaluate the following biomarkers: CD3+, CD4+, and CD8+ , and changes in PD-L1 expression at baseline and following first cycle of BMS-936558and SBRT.","time_frame":"at baseline/inclusion visit and Day20 (after radiotherapy)","description":"biomarkers will be assessed from baseline biopsy and after receiving first BMS-936558and SBRT for changes.\r\nCD3+, CD4+, and CD8+: Will be quantified in mm2 in the most abundant tumor-infiltrating area in both, the stroma and the tumor, of the baseline biopsy (continuous variable) PD-L1: Will be evaluated on tumor cells and infiltrating immune T cells and be classified as negative or positive or not applicable (categorical variable)"}]}
{"nct_id":"NCT04693611","start_date":"2021-04-14","phase":"N/A","enrollment":36,"brief_title":"Prefrontal Cortex Dynamics of the Elderly During a Cognitive Stimulation Programme","official_title":"Prefrontal Cortex Dynamics of the Elderly During a Cognitive Stimulation Programme: A Randomized and Controlled Trial in Old Adults With Normal Cognition and Mild Cognitive Impairment","primary_completion_date":"2021-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2021-08-31","last_update":"2021-09-01","description":"This research aims to evaluate the effect of cognitive stimulation (CS) on the functioning of the prefrontal cortex (PFC), seeking an analysis of both cerebral hemodynamics in neuroplasticity and aspects related to the initiation of neurodegenerative processes. The intervention presents an individual format and the participants are elderly without or with neurocognitive disorders (NCD). Concretely, to assess the effects of individual CS on global cognition, and mood, as well as to analyze neuronal activity with oxygenation, volume and blood flow in the brain, evaluating the impact of cognitive stimulation on brain hemodynamics. Participants in the intervention group receive two 45 min-session of CS per week for 12 weeks in addition to their treatment as usual. Participants in the control group will maintain their treatment as usual.","other_id":"16122020","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Being 65 years of age or older.\r\n\r\n          -  Being able to communicate and understand.\r\n\r\n          -  Being a native Portuguese speaker.\r\n\r\n          -  Educational level equal to or higher than 4 years old.\r\n\r\n          -  Have given informed consent for the project, duly completed and signed, after prior\r\n             information.\r\n\r\n          -  Have a score of 22 or more points in the MMSE.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Suffering from an acute or severe illness that prevent participation in the\r\n             intervention sessions.\r\n\r\n          -  Severe sensory and physical limitations that prevent participation.\r\n\r\n          -  Low level of consciousness and minimal attention span.\r\n\r\n          -  Presence of severe neuropsychiatric symptoms (such as agitation, psychosis, severe\r\n             depressive and anxiety symptoms, apathy), or presence of uncontrolled delirium that\r\n             would prevent participation in the sessions.\r\n\r\n          -  History of seizures or cerebrovascular disease.\r\n\r\n          -  Movement disorders diagnosis.\r\n\r\n          -  Psychoactive substances consumption.\r\n      ","sponsor":"CEDIARA - Assoc. Solidariedade Social de Ribeira de Frguas","sponsor_type":"Other","conditions":"Dementia|Neurocognitive Disorders|Cognitive Impairment|Cognitive Dysfunction|Cognitive Decline|Cognition Disorders in Old Age","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Individual cognitive stimulation therapy (iCST)","description":"The intervention group will receive 24 individual CS sessions per participant. Each session will last approximately 45 minutes and will have the following structure: session introduction (5 minutes); reality orientation (10 minutes); stimulation of cognitive domain (25 minutes); session closure (5 minutes). The sessions will be led by a previously trained therapist. The intervention program will include several activities based on the principles of CS and adjusted for participants without any neurocognitive disorder."},{"intervention_type":"Procedure","name":"Procedure: Functional near-infrared spectroscopy (fNIRS)","description":"The acquisition by fNIRS will be performed in each CS session in four regions of interest (ROIs) in the prefrontal cortex: left dorsolateral prefrontal cortex (LDLPFC); left medial prefrontal cortex (LMPFC); right medial prefrontal cortex (RMPFC); right dorsolateral prefrontal cortex (RDLPFC)."}],"outcomes":[{"outcome_type":"primary","measure":"Cognitive functioning evaluated through Mini-Mental State Examination (MMSE)","time_frame":"baseline","description":"Significant statistic improvement in the participant's test scores between pre-intervention assessment and postintervention assessment. MMSE is a brief cognitive screening test. Scores range between 0-30 points. Higher scores indicate better cognitive function."},{"outcome_type":"primary","measure":"Change in cognitive functioning evaluated through MMSE","time_frame":"12 weeks after the beginning of the intervention","description":"Significant statistic improvement in the participant's test scores between pre-intervention assessment and postintervention assessment. MMSE is a brief cognitive screening test. Scores range between 0-30 points. Higher scores indicate better cognitive function."},{"outcome_type":"primary","measure":"Executive functions evaluated through Frontal Assessment Battery (FAB)","time_frame":"baseline","description":"Significant statistic improvement in the participant's test scores between pre-intervention assessment and postintervention assessment. FAB assesses executive functions such as abstract thinking, mental flexibility, motor programming, interference sensibility, inhibitory control and environmental independence. Scores range between 0 - 18 points. Higher scores indicate better cognitive function."},{"outcome_type":"primary","measure":"Change in executive functions evaluated through FAB","time_frame":"12 weeks after the beginning of the intervention","description":"Significant statistic improvement in the participant's test scores between pre-intervention assessment and postintervention assessment. FAB assesses executive functions such as abstract thinking, mental flexibility, motor programming, interference sensibility, inhibitory control and environmental independence. Scores range between 0 - 18 points. Higher scores indicate better cognitive function."},{"outcome_type":"primary","measure":"Prefrontal cortex activation pattern through a fNIRS","time_frame":"baseline","description":"Analysis of Oxyhemoglobin (HbO2) and Deoxyhemoglobin (HHb) variation in four regions of interest (ROIs) in the PFC: left prefrontal dorsolateral cortex (LDLPFC); left medial prefrontal cortex (LMPFC); right medial prefrontal cortex (RMPFC); right dorsolateral prefrontal cortex (RDLPFC). An increase in brain activity is generally assumed to reflect an increase in HbO2 and decrease in HHb as based on a mechanism known as neurovascular coupling."},{"outcome_type":"primary","measure":"Change in prefrontal cortex activation pattern through a fNIRS","time_frame":"during the intervention","description":"Analysis of Oxyhemoglobin (HbO2) and Deoxyhemoglobin (HHb) variation in four regions of interest (ROIs) in the PFC: left prefrontal dorsolateral cortex (LDLPFC); left medial prefrontal cortex (LMPFC); right medial prefrontal cortex (RMPFC); right dorsolateral prefrontal cortex (RDLPFC). An increase in brain activity is generally assumed to reflect an increase in HbO2 and decrease in HHb as based on a mechanism known as neurovascular coupling."},{"outcome_type":"secondary","measure":"Depressive symptomatology assessed through the Geriatric Depression Scale-15 (GDS-15)","time_frame":"baseline","description":"Participants' scores in the GDS-15. This instrument evaluated depressive symptoms using yes/no answers. Scores range between 0 and 15 points. Higher scores indicate more severe depressive symptoms."},{"outcome_type":"secondary","measure":"Change in depressive symptomatology assessed through the GDS-15","time_frame":"12 weeks after the beginning of the intervention","description":"Participants' scores in the GDS-15. This instrument evaluated depressive symptoms using yes/no answers. Scores range between 0 and 15 points. Higher scores indicate more severe depressive symptoms."},{"outcome_type":"other","measure":"Sociodemographic information gathered through the sociodemographic questionnaire","time_frame":"baseline","description":"Participants' answers in the sociodemographic questionnaire designed specifically for this study. It gathers information about gender, age, marital status, formal education, which social response the participant attends, medical comorbidities and cognitive symptoms and will be administered to all participants."},{"outcome_type":"other","measure":"Adherence to the intervention and dropouts evaluated through a session form","time_frame":"during the intervention","description":"Adherence to the intervention and dropouts will be assessed using a session form, designed specifically for this study, completed by the technician after each session, regarding the attendance and mood/behavior of the participants throughout the intervention sessions."}]}
{"nct_id":"NCT04882631","start_date":"2021-04-13","phase":"Phase 1","enrollment":25,"brief_title":"A Study to Evaluate the Skin Irritation Potential of PBI-100 Topical Cream in Healthy Participants","official_title":"A 21 Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of PBI-100 Topical Cream in Healthy Participants Using a Cumulative Irritant Patch Test Design","primary_completion_date":"2021-05-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-05-31","last_update":"2021-05-12","description":"This is an open-label, single-arm, randomized, evaluator-blinded repeat insult patch testing (RIPT) study wherein test product is applied under an occlusive dressing to the upper back or arm continuously and repeatedly to the same site for a period of 21 days.","other_id":"PBI-100-101","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","intervention_model_description":"The order of test product patch placement is randomized.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy adult male and female volunteers between the ages of 18 and 70 years with\r\n             Fitzpatrick types I, II, or III.\r\n\r\n          -  Must be willing to follow the study requirements and voluntarily give their informed\r\n             consent.\r\n\r\n          -  Subjects must be able to read and follow study instructions in English.\r\n\r\n          -  Generally in good health as determined by the investigator, based on medical history\r\n             interview.\r\n\r\n          -  Evidence of a personally signed and dated Informed Consent indicating that the subject\r\n             has been informed of and understood all pertinent aspects of the trial.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Scars, moles, or other blemishes over the forearm, upper arm, or back that interfere\r\n             with the study.\r\n\r\n          -  Sunburn within the last three weeks or use of tanning beds.\r\n\r\n          -  History of allergy or hypersensitivity to skin care or consumer products including\r\n             fragrances, cosmetics, toiletries, or any kind of tape.\r\n\r\n          -  History of chronic or recurrent dermatological diseases, e.g., psoriasis, atopic\r\n             eczema, chronic urticaria.\r\n\r\n          -  Subjects receiving systemic or topical drugs which can interfere with the development\r\n             of an inflammatory response, e.g., steroids, immunosuppressive agents, or retinoids.\r\n\r\n          -  History of any significant systemic diseases e.g., cardiac, pulmonary, renal, hepatic,\r\n             etc. that would impact subject's ability to complete the study.\r\n\r\n          -  Pregnancy or mothers who are breastfeeding or planning a pregnancy.\r\n\r\n          -  Other conditions considered by the Investigator as sound reasons for disqualification\r\n             from enrollment into the study.\r\n      ","sponsor":"Pyramid Biosciences","sponsor_type":"Industry","conditions":"Healthy Volunteers","interventions":[{"intervention_type":"Drug","name":"Drug: PBI-100 Topical Cream","description":"A dose of approximately 560 ug (approximately 0.4 mL of each of the three concentrations to 3 different sites) of PBI-100 was applied daily (excluding weekends) to the skin test sites."},{"intervention_type":"Drug","name":"Drug: Positive Control - Sodium laurel sulfate (SLS)","description":"Approximately 0.4 mL of 0.25% SLS was applied daily (excluding weekends) as a positive control test site."},{"intervention_type":"Other","name":"Other: PBI-100 Topical Cream, Vehicle","description":"Approximately 0.4 mL of 0% placebo cream was applied daily (excluding weekends) as a positive control test site."},{"intervention_type":"Other","name":"Other: Negative Control","description":"A blank patch was applied daily (excluding weekends) as a negative control test site."}],"outcomes":[{"outcome_type":"primary","measure":"Irritation Potential","time_frame":"21 days","description":"Irritation potential based on the Cumulative Irritation Index (CII)"}]}
{"nct_id":"NCT04475783","start_date":"2021-04-13","phase":"N/A","enrollment":478,"brief_title":"Sirolimus- vs. Paclitaxel-Drug Coated Ballons in Patients With Peripheral Artery Disease","official_title":"Head-to-Head Comparison of SIROlimus Versus Paclitaxel Drug-Eluting BallooN Angioplasty in the Femoropopliteal Artery","primary_completion_date":"2027-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2028-05-31","last_update":"2021-07-09","description":"This study is a prospective, interventional, multi-center 1:1 randomized non-inferiority trial. The trial evaluates the safety and efficacy of the Magic Touch PTA sirolimus drug-coated balloon in comparison to the treatment with PTX drug-coated balloon (control device) in patients with femoropopliteal artery disease.","other_id":"ZKSJ0127","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"1:1-randomization, parallel design, stratified by Center.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Subject age  18\r\n\r\n          2. Subject has been informed on the nature of the study, the duration of the study,\r\n             agrees to attend follow-up visits, agrees to complete the required testing, agrees to\r\n             participate, and has signed an informed consent form.\r\n\r\n          3. Rutherford category 2-4 according to the investigator's subjective evaluation\r\n\r\n          4. Subject has a de novo or restenosed lesion with  70 % stenosis documented\r\n             angiographically\r\n\r\n          5. Target lesion length is  2 cm and  20 cm by visual estimate of the treating\r\n             physician\r\n\r\n          6. Multiple lesions with max. 3 cm healthy vessel segment in between lesions can be\r\n             considered at the discretion of the operator as one lesion. Total lesion length should\r\n             not exceed 20 cm\r\n\r\n          7. Reference vessel diameter (RVD)  4 mm and  6.5 mm by visual estimation\r\n\r\n          8. Patency of P2 and P3 segment of the popliteal artery and at least one (1)\r\n             infrapopliteal artery to the ankle (< 50 % diameter stenosis) in continuity with the\r\n             femoropopliteal artery\r\n\r\n          9. Patency of ipsilateral iliac artery ( 30% diameter stenosis). Iliac artery stenosis >\r\n             30 % may be treated during the index procedure to ensure sufficient inflow.\r\n\r\n         10. A guidewire has successfully traversed the target treatment segment intraluminal\r\n\r\n         11. Vascular disease in the opposite leg that requires treatment at the time point of\r\n             index procedure is allowed, but has to be treated according to randomization or with\r\n             POBA.\r\n\r\n         12. A patient can only be enrolled and randomized once with only one target lesion in the\r\n             SIRONA trial. Please note that only the lesion in one limb can be treated as target\r\n             lesion for index procedure.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Failure to successfully cross the target lesion or subintimal target lesion guidewire\r\n             crossing\r\n\r\n          2. Flow-limiting dissection after pre-dilatation\r\n\r\n          3. Angiographic evidence of severe calcification of the target vessel (contiguous\r\n             calcification on both sides of the vessel)\r\n\r\n          4. Presence of fresh thrombus in the target lesion\r\n\r\n          5. Presence of aneurysm in the target vessel/s\r\n\r\n          6. Prior vascular surgery (including atherectomy, bypass surgery) of the target limb\r\n\r\n          7. Prior stent in the target lesion\r\n\r\n          8. Stroke or heart attack within 3 months prior to enrollment\r\n\r\n          9. Any vascular surgical procedure or intervention performed in the target limb within 30\r\n             days prior to or planned within 30 days post index procedure\r\n\r\n         10. Any vascular treatment with PTX or sirolimus-coated devices 60 days prior to index\r\n             procedure\r\n\r\n         11. Target lesion requires treatment with alternative therapies such as primary stenting,\r\n             laser, lithotripsy, thrombectomy, atherectomy, cryoplasty, brachytherapy, re-entry\r\n             devices\r\n\r\n         12. Enrolled in another investigational drug, device or biologic study\r\n\r\n         13. Life expectancy of less than one year in the investigator's opinion\r\n\r\n         14. Known allergies or sensitivity to heparin, aspirin, other anticoagulant/ antiplatelet\r\n             therapies, sirolimus, paclitaxel or contrast media that cannot be adequately\r\n             pre-treated prior to index procedure\r\n\r\n         15. Significant gastrointestinal bleeding or any coagulopathy that would contra-indicate\r\n             the use of anti-platelet therapy\r\n\r\n         16. Receiving dialysis or immunosuppressant therapy\r\n\r\n         17. Pregnant or lactating females\r\n\r\n         18. History of major amputation in the same limb as the target lesion\r\n      ","sponsor":"Jena University Hospital","sponsor_type":"Other","conditions":"Peripheral Artery Disease","interventions":[{"intervention_type":"Combination Product","name":"Combination Product: Percutaneous Transluminal Angioplasty (PTA)","description":"PTA with an drug-coated balloon catheter (DCB) in the femoropopliteal artery"}],"outcomes":[{"outcome_type":"primary","measure":"Patency rate (Absence of clinically driven target lesion revascularization)","time_frame":"one year after study procedure (PTA with medical product under investigation or comparator)","description":"patency rate after one year defined as absence of clinically driven target lesion revascularization (TLR) due to symptoms and drop of ABI of ≥ 20% or > 0.15 when compared to post-procedure or restenosis with PVR > 2.4 evaluated by duplex ultrasound"},{"outcome_type":"primary","measure":"Safety outcome","time_frame":"through 12 months post-procedure","description":"Composite of freedom from device and procedure-related death through 12 months post procedure as well as freedom from both target limb major amputation and clinically-driven target vessel vessel revasculariza-tion"},{"outcome_type":"secondary","measure":"TLR rate","time_frame":"1, 6, 12, 24, 36, 48 and 60 months after study procedure","description":"ocurrence of Target lesion revascularization (TLR) at certain time Points"},{"outcome_type":"secondary","measure":"Rutherford classification","time_frame":"at 12 months after study procedure","description":"Sustained clinical improvement: an improvement shift in the Rutherford classification of one class in amputation and TVR free surviving patients"},{"outcome_type":"secondary","measure":"Walking capacity assessment 1","time_frame":"at 1, 6, 12, 24, 36, 48 and 60 months after study procedure","description":"patient-self-assessment of walking distance"},{"outcome_type":"secondary","measure":"Walking capacity assessment 2","time_frame":"at 6, 12, 24, 48 months after study procedure","description":"6-minute Walking test (6MWT)"},{"outcome_type":"secondary","measure":"Walking capacity assessment 3","time_frame":"at 6, 12, 24, 48 months after study procedure","description":"Treadmill test (optional)"},{"outcome_type":"secondary","measure":"Walking capacity assessment 4","time_frame":"at 6, 12, 24, 48 months after study procedure","description":"Walking Impairment Questionnaire (WIQ); 20 questions (scale 0 to 4); best score 0, worst score 80"},{"outcome_type":"secondary","measure":"Duplex Ultrasound","time_frame":"post-procedure and at 6, 12, 24 and 48 months or at any time of re-intervention","description":"Duplex-defined binary restenosis (PSVR >2.4) of the target lesion"},{"outcome_type":"secondary","measure":"ABI","time_frame":"at discharge, 6, 12, 24 and 48 months","description":"Ankle brachial index (ABI)"},{"outcome_type":"secondary","measure":"Qualilty of Life Assessment","time_frame":"at 1 month, 6, 12, 24, 36, 48 and 60 months","description":"Quality of life assessment (QoL) by EQ5D-3L questionnaire; 5 questions (scale 1 to 5), best score 5, worst score 25"},{"outcome_type":"secondary","measure":"Secondary Safety: freedom from all cause death, target limb major amputation and clinically-driven target vessel revascularization","time_frame":"trough 60 months after study procedure","description":"Composite of freedom from all cause death through 60 months post procedure as well as freedom from both target limb major amputation and clinically-driven target vessel revascularization"}]}
{"nct_id":"NCT04803786","start_date":"2021-04-10","enrollment":350,"brief_title":"A Patient-Centric, Prospective, Observational, Non-Interventional Switch Study of XYWAV in Narcolepsy","official_title":"Transition Experience of Persons With Narcolepsy Taking Oxybate in the Real-world (TENOR): A Patient-Centric, Prospective, Observational, Non-Interventional Study to Assess Dosing Regimen in Persons Switching From Xyrem to Xywav for the Treatment of Narcolepsy","primary_completion_date":"2022-03-07","study_type":"Observational","rec_status":"Recruiting","completion_date":"2022-03-07","last_update":"2021-08-03","description":"The rationale for the patient-centric, prospective, observational, non-interventional study design of JZP258-402 is to evaluate the transition experience of participants with narcolepsy treated with oxybate and to examine the impact of transitioning from Xyrem to Xywav in a real-world setting.","other_id":"JZP258-402","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Male or female asges 18 years and older with diagnosis of type 1 or type 2 narcolepsy. On\r\n        an active prescription for Xyrem with stable treatment for at least 2 consecutive months.","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Male or female, aged 18 years or older\r\n\r\n          2. Diagnosis of type 1 or type 2 narcolepsy by a physician\r\n\r\n          3. Active prescription for Xyrem with a stable treatment regimen for at least 2\r\n             consecutive months\r\n\r\n          4. Transitioning from Xyrem to Xywav within the next or past 7 days (- 7 days or + 7 days\r\n             from the first dose of Xywav)\r\n\r\n          5. Able to read and understand English\r\n\r\n          6. Able to access to a computer/smart phone with internet connection\r\n\r\n          7. Not currently a Jazz Pharmaceuticals employees or an immediate family member of a Jazz\r\n             employee\r\n\r\n          8. Willing and able to comply with the study schedule\r\n\r\n          9. Willing and able to provide electronically written informed consent\r\n      ","sponsor":"Jazz Pharmaceuticals","sponsor_type":"Industry","conditions":"Narcolepsy","interventions":[{"intervention_type":"Drug","name":"Drug: Transition from Xyrem to Xywav","description":"This is a single-group non-interventional study where participant's transitioning from Xyrem to Xywav will be observed. Investigational product (IP) or drug support or requested changes to their medication will not be provided to participants by Jazz Pharmaceuticals. The Xyrem and Xywav that the participants will take will be provided by the participant's health care provider."}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants with Increased/Decreased/Same Dose Transitioning from Xyrem to Xywav","time_frame":"Baseline to 21 Weeks","description":"• Difference between usual Xyrem total nightly dose and initial prescribed total nightly Xywav dose."},{"outcome_type":"secondary","measure":"Number Prescribed Dose Adjustments of Xywav","time_frame":"Baseline to 21 Weeks","description":"The number of dosing adjustments per participants and number of participants with one or more dosing adjustments during the Xywav Treatment Period (Period 2 to 5) by treating physician (dosing amount or number of nightly doses), details of adjustment, reason for adjustment and reason for unequal dosing will be summarized."},{"outcome_type":"secondary","measure":"Duration of Time Between the Last Meal Relative to Dosing","time_frame":"Baseline to 21 Weeks","description":"Timing and type of last meal prior to the first dose will be collected using both Daily Diary and Weekly Lookback of Daily Diary. The timing will be collected as actual time (HH:MM) from Daily Diary and as categorical data of usual number of hours relative to first dose (<0.5 hours, ≥0.5 but <1 hours, ≥1 but <1.5 hours, ≥1.5 but <2 hours, ≥2 hours) from Weekly Lookback of Daily Diary. In order to evaluate the timing of last meal across all study periods, the Daily Diary entry will be converted into categorical data using the same value scale as Weekly Lookback of Daily Diary. The type of last meal prior to the first dose will be collected as categorical data (regular meal, snack, and beverage). For both timing and type of last meal prior to the first dose, the number of participants with each response will be summarized."},{"outcome_type":"other","measure":"Time to Achieve Stable Dose of Xywav","time_frame":"Baseline to 21 Weeks","description":"Stable dose is defined as the dose and regimen which remain unchanged for at least 2 weeks. Compliance is not considered in the derivation of the time to stable dose. The time to achieve stable dose will be summarized."},{"outcome_type":"other","measure":"Number of Participants Achieving Treatment Adherence","time_frame":"Baseline to 21 Weeks","description":"Skipped doses will be collected using both the Daily Diary and Weekly Lookback Daily Diary. Skipped doses will be collected daily (yes/no) from the Daily Diary and as a weekly categorical variable (0, 1-2, 3-4, 5-6, or 7 days) from the Weekly Lookback of Daily Diary. In order to summarize skipped doses during the Xywav Treatment Period, the Daily Diary data will be converted to categorical data using the same categories as in the Weekly Lookback of Daily Diary. Skipped doses per week (0, 1-2, 3-4, 5-6, 7 days), most common dosing change (did not take Xywav, skipped first dose, skipped second dose, skipped third dose) and most common reasons for dosing change will be summarized."},{"outcome_type":"other","measure":"Number of Participants Who Discontinued Xywav Administration","time_frame":"Baseline to 21 Weeks","description":"The number of participants who discontinued Xywav administration during the Xywav Treatment Period (Period 2 to 5)."},{"outcome_type":"other","measure":"Change in Short-term and Long-term Nausea Using Patient Global Impression of Change (PGI-C)","time_frame":"Baseline to 21 Weeks","description":"The PGI-C is a series of self-administered questions designed to measure the meaningfulness of change in symptoms following an intervention. The PGI-C is used to assess the change in excessive daytime sleepiness, cataplexy, and short- and long-term nausea since the transition from Xyrem to Xywav. It is a 7-point Likert-type rating scale from 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, to 7 = very much worse. The score is the sum of responses to each of the answer choices."},{"outcome_type":"other","measure":"Changes in Sleep Pattern and Quality","time_frame":"Baseline to 21 Weeks","description":"Sleep pattern (how long usually took to fall asleep after the first dose, how long usually spent awake during the night) will be summarized. Sleep pattern and quality will be collected using both Daily Diary and Weekly Lookback of Daily Diary. The number of participants with each response to sleep quality (very poor ~ very good) and feeling on how rested/refreshed when woke-up for the day (not at all rested ~ very well rested) will be summarized by day and by week. In order to analyze the data together the intention is to combine the daily by deriving the categorical frequency for the responses so that it can be combined with the categorical data collected in the weekly diary. Which will allow for a full analysis of the change from the Baseline period (Xyrem) to Xywav Treatment Period (Period 2 to 5) will be summarized for weekly data collected during the Xywav Treatment Period (Period 2 to 5) using Weekly Lookback of Daily Diary."},{"outcome_type":"other","measure":"Change in Epworth Sleepiness Scale (ESS)","time_frame":"Baseline to 21 Weeks","description":"The ESS is a self-administered questionnaire with 8 questions (Johns 1991, Johns 1992). Respondents rate on a 4-point scale (0-3) their usual chances of dozing off or falling asleep while engaged in eight different activities. Most people engage in those activities at least occasionally, although not necessarily every day. The ESS total score (the sum of 8 item scores, 0-3) can range from 0 to 24. Higher ESS total scores are associated with higher sleep propensity in daily life, also referred to as 'daytime sleepiness'. The ESS has been validated in several conditions, including narcolepsy (Johns 1994)."},{"outcome_type":"other","measure":"Change in Functional Outcomes of Sleep Questionnaire (FOSQ-10) Total Score","time_frame":"Baseline to 21 Weeks","description":"The FOSQ-10 (Chasens 2009) is a self-administered questionnaire designed to assess the impact of daytime sleepiness on activities of daily living. It consists in 10 items measuring the participant's general productivity, activity level, vigilance, and intimacy and sexual relationships. For each item, participants are asked to rate the level of difficulty in completing an activity on a 4-point Likert scale, from 1 \"Yes, extreme\" to 4 \"No\"). From the FOSQ-10 a total score is calculated: a higher score indicates better functional status. The FOSQ-10 is a reduced version of the original FOSQ-30. The FOSQ-10 was tested and found to be a psychometrically strong instrument performing similarly to the long version."},{"outcome_type":"other","measure":"Change in British Columbia Cognitive Complaint Inventory (BC-CCI) Total Score","time_frame":"Baseline to 21 Weeks","description":"The BC-CCI was developed to measure cognitive complaints in individuals with Major Depressive Disorder (MDD). It is a 6-item self-report measure that asks respondents to rate problems with specific cognitive symptoms over the past 7 days. A four point scale (0 \"Not at all\" to 3 \"Very much\") is used to rate each item. The total score (ranges from 0 to 18) that is generated assesses domains of memory, concentration, trouble expressing thoughts, word-finding, and problem solving. Higher scores indicate greater severity of cognitive impairment, with four established classification ranges for the BC-CCI total score: 0 to 4 = \"broadly normal\"; 5 to 8 = \"mild\" cognitive complaints; 9 to 14 = \"moderate\" cognitive complaints; and 15 to 18 = \"severe\" cognitive complaints. Three additional items that ask about how these symptoms impact work, relationships and social/recreational activities are also included to provide further information on the nature of functional impairment."},{"outcome_type":"other","measure":"Change in Cataplexy using PGI-c","time_frame":"Baseline to 21 Weeks","description":"The PGI-C is a series of self-administered questions designed to measure the meaningfulness of change in symptoms following an intervention. The PGI-C is used to assess the change in excessive daytime sleepiness, cataplexy, and short- and long-term nausea since the transition from Xyrem to Xywav. It is a 7-point Likert-type rating scale from 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, to 7 = very much worse. The score is the sum of responses to each of the answer choices."}]}
{"nct_id":"NCT04902066","start_date":"2021-04-09","phase":"N/A","enrollment":256,"brief_title":"Face Your Fears: Cognitive Behavioural Virtual Reality Therapy for \"Paranoia\".","official_title":"Face Your Fears: An Assessor-blinded, RCT Evaluating the Effectiveness of Cognitive Behavioural Virtual Reality Therapy Versus Cognitive Behavioural Therapy in Patients With Schizophrenia Spectrum Disorders.","primary_completion_date":"2023-10-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2024-07-01","last_update":"2021-05-26","description":"The study is a randomised, assessor-blinded parallel-groups superiority clinical trial fulfilling the CONSORT criteria for non-pharmacological treatment. A total of 256 patients will be allocated to either Cognitive Behavioural Virtual Reality Therapy plus treatment as usual, versus traditional CBT for psychosis plus treatment as usual. All participants will be assessed at baseline and 3- and 9 months post baseline. A stratified block-randomisation with concealed randomisation sequence will be conducted. Independent assessors blinded to the treatment will evaluate outcome. Analysis of outcome will be carried out with the intention to treat principles.","other_id":"0134-00066B and ID 148727","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","intervention_model_description":"A randomised, assessor-blinded parallel-groups superiority clinical trial.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age 18 - years\r\n\r\n          2. Ability to give informed consent\r\n\r\n          3. A schizophrenia spectrum disorder (ICD-10 code: F20 -F29)\r\n\r\n          4. Green Paranoid Thought Scale total score  40\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Rejecting informed consent\r\n\r\n          2. A diagnosis of organic brain disease\r\n\r\n          3. IQ of 70 or lower (known mental retardation as assessed by medical record)\r\n\r\n          4. A command of spoken Danish or English inadequate for engaging in therapy\r\n\r\n          5. Inability to tolerate the assessment process\r\n      ","sponsor":"Mental Health Services in the Capital Region, Denmark","sponsor_type":"Other","conditions":"Paranoid Schizophrenia|Schizophrenia and Related Disorders|Schizophrenia Prodromal|Schizotypal Disorder|Paranoid Ideation|Paranoid Delusion|Ideas of Reference|Psychosis Paranoid|Psychotic Disorders|Psychotic Paranoia|Psychotic; Disorder, Delusional","interventions":[{"intervention_type":"Other","name":"Other: Cognitive Behavioural Virtual Reality Therapy.","description":"Cognitive Behavioural Therapy augmented with Virtual Reality."},{"intervention_type":"Other","name":"Other: Traditional Cognitive Behavioural Therapy","description":"Traditional Cognitive Behavioural Therapy for psychosis."}],"outcomes":[{"outcome_type":"primary","measure":"(GPTS) Green Paranoid Thought Scale Part B: Paranoid ideation.","time_frame":"3 months from inclusion","description":"The primary outcome is level of non-bizarre delusional ideas measured with Green Paranoid Thought Scale ideas of persecution at cessation of treatment at 3-months. The Green Paranoid Thought Scale has displayed good reliability and validity in patients with psychosis, displaying paranoid, persecutory delusions, and has also been used in patients at-risk for psychosis showing subthreshold psychotic symptoms.\r\nMinimum total score: 32. Maximum total score: 160. Part A (Ideas of reference) minimum score: 16 and maximum score: 80. Part B (Paranoid ideation) minimum score 16 and maximum score: 80. Part B score = or > 45 are assumed to be threshold for development of delusion. Higher score means worse outcome."},{"outcome_type":"secondary","measure":"SIAS (Social Interaction Anxiety Scale)","time_frame":"3 and 9 months from inclusion","description":"Minimum score: 0 Maximum score: 20*4=80. Item 5,9 and 11 have reverse score. Higher score means worse outcome."},{"outcome_type":"secondary","measure":"SBQ (Safety Behaviour Questionnaire)","time_frame":"3 and 9 months from inclusion","description":"Minimum score: 0. Maximum score is in theory unlimited depending on the number of identified, specific safety behaviours."},{"outcome_type":"secondary","measure":"PSP (Personal and Social Performance Scale)","time_frame":"3 and 9 months from inclusion","description":"Minimum score: 1 Maximum score: 100. Higher score means better outcome."},{"outcome_type":"secondary","measure":"CANTAB ERT (Emotion Recognition Task)","time_frame":"3 and 9 months from inclusion"},{"outcome_type":"secondary","measure":"(GPTS) Green Paranoid Thought Scale Part A: Ideas of reference","time_frame":"3 and 9 months from inclusion","description":"Minimum total score: 32. Maximum total score: 160. Part A (Ideas of reference) minimum score: 16 and maximum score: 80. Part B (Paranoid ideation) minimum score 16 and maximum score: 80. Part B score = or > 45 are assumed to be threshold for development of delusion. Higher score means worse outcome."},{"outcome_type":"secondary","measure":"(GPTS) Green Paranoid Thought Scale Part B: Paranoid ideation.","time_frame":"9 months from inclusion","description":"The primary outcome is level of non-bizarre delusional ideas measured with Green Paranoid Thought Scale ideas of persecution at cessation of treatment at 3-months. The Green Paranoid Thought Scale has displayed good reliability and validity in patients with psychosis, displaying paranoid, persecutory delusions, and has also been used in patients at-risk for psychosis showing subthreshold psychotic symptoms.\r\nMinimum total score: 32. Maximum total score: 160. Part A (Ideas of reference) minimum score: 16 and maximum score: 80. Part B (Paranoid ideation) minimum score 16 and maximum score: 80. Part B score = or > 45 are assumed to be threshold for development of delusion. Higher score means worse outcome."},{"outcome_type":"other","measure":"CDSS (Calgary Depression Scale for Schizophrenia)","time_frame":"3 and 9 months from inclusion","description":"Minimum score: 0 Maximum score: 9*3 = 27. Higher score means worse outcome."},{"outcome_type":"other","measure":"BNSS (Brief Negative Symptom Scale)","time_frame":"3 and 9 months from inclusion","description":"13 items with a score from minimum 0 to maximum 6 for each item. Higher score means worse outcome."},{"outcome_type":"other","measure":"COGDIS (Cognitive disturbances scale)","time_frame":"3 and 9 months from inclusion","description":"Score of 0-6 indicate a range. Minimum score: 0 Maximum score: 9*6 = 54. Higher score means worse outcome. Trait phenomenons are coded with a \"7\", unknown degree of severly is coded with a \"8\" and uncertainty whether the symptom is present is coded with a \"9\"."},{"outcome_type":"other","measure":"SAPS (Scale for the Assesment of Positive symptoms)","time_frame":"3 and 9 months from inclusion","description":"Composite total score: Minimum score: 0 Maximum score: 30*5 = 150. Higher score means worse outcome.\r\nGlobal score: Minimum score: 0 Maximum score: 4*5 = 20. Higher score means worse outcome."},{"outcome_type":"other","measure":"Trustworthiness Scale","time_frame":"3 and 9 months from inclusion","description":"Minimum score: -3*42=-126 Maximun score: +3*42=126. Higher positive score means better outcome. Higher negative score means worse outcome."},{"outcome_type":"other","measure":"DACOBS (Davos Assessment of the Cognitive Biases Scale)","time_frame":"3 and 9 months from inclusion","description":"Total score: Minimum score: 1*42=42. Maximum score:7*42=294. Higher score means worse outcome.\r\nSubscales of:\r\nJumping to conclusions bias: Item 3+8+16+18+25+30 Belief Inflexibility bias: Item 13+15+26+34+38+41 Attention for Threat bias: Item 1+2+6+10+20+37 External Attribution bias: Item 7+12+17+22+24+29\r\nSocial Cognition problems: Item 4+9+11+14+19+39 Subjective Cognitive problems: Item 5+21+28+32+36+40\r\nSafety behaviors: Item 23+27+31+33+35+42"},{"outcome_type":"other","measure":"SIDAS (Suicidal Ideation Attributes Scale)","time_frame":"3 and 9 months from inclusion","description":"Minimum score: 0. Maximum score: 50. Item 2 has a reverse score. Higher score means worse outcome."},{"outcome_type":"other","measure":"BCSS (The Brief Core Schema Scales: Beliefs about self and others)","time_frame":"3 and 9 months from inclusion","description":"Items with negative belief of self and others: Minimum score: 0. Maximum score: 2*6*4= 48. Higher score means worse outcome.\r\nItems with Positive belief of self and others: Minimum score: 0. Maximum score: 2*6*4= 48. Higher score means better outcome."},{"outcome_type":"other","measure":"SSPA (Social Skills Performance Assessment)","time_frame":"3 and 9 months from inclusion","description":"Scene I: Minimum score: 1*8=8. Maximum score: 5*8:40. Higher score means better outcome.\r\nScene II: Minimum score: 1*9=9. Maximum score: 5*9:45. Higher score means better outcome."},{"outcome_type":"other","measure":"TALE (Trauma And Life Events checklist)","time_frame":"Baseline measure"},{"outcome_type":"other","measure":"IBT (Intentionality Bias Task)","time_frame":"3 and 9 months from inclusion"},{"outcome_type":"other","measure":"(R-GPTS) Revised Green Paranoid Thought Scale","time_frame":"3 and 9 months from inclusion","description":"Minimum total score: 0. Maximum total score: 4*18=72. Part A (Ideas of reference) minimum score: 0 and maximum score: 4*8=32. Part B (Paranoid ideation) minimum score 0 and maximum score: 4*10=40. Part B score = or > 18 are assumed to be threshold for development of delusion. Higher score means worse outcome."},{"outcome_type":"other","measure":"GSE (General Self Efficacy Scale)","time_frame":"3 and 9 months from inclusion","description":"Minimum score: 1*10=10. Maximum score: 4*10=40. Higher score means better outcome."},{"outcome_type":"other","measure":"Big-5 (personality traits)","time_frame":"3 and 9 months from inclusion","description":"5 spectrums of personality traits assessed with 5 items each.\r\nMinimum score for each personality trait: Minimum score: 1*5=5. Maximum score: 5*5=25\r\nCertain items have reverse scores."},{"outcome_type":"other","measure":"EQ-5D-5L (EuroQOL five dimensions questionnaire)","time_frame":"3 and 9 months from inclusion","description":"Scoring the descriptive system:\r\nMinimum score: 1-1-1-1-1. Maximum score: 5-5-5-5-5. Higher score means worse outcome.\r\nScoring the VAS:\r\nMinimum score: 0. Maximum score: 100. Higher score means better outcome."},{"outcome_type":"other","measure":"WHO (World Health Organization 5)","time_frame":"3 and 9 months from inclusion","description":"Minimum score: 0. Maximum score: 5*5*4=100. Higher score means better outcome."},{"outcome_type":"other","measure":"CSQ (Client Satisfaction Questionnaire)","time_frame":"3 months follow-up"},{"outcome_type":"other","measure":"SFS (The Social Functioning Scale)","time_frame":"3 and 9 months from inclusion","description":"Minimum raw score: 0. Maximum raw score: 15+9+39+45+66+39+19=223. Higher score means better outcome."}]}
{"nct_id":"NCT04253951","start_date":"2021-04-01","phase":"N/A","enrollment":150,"brief_title":"Lung Ultrasound for Infants' Swallowing Disorders","official_title":"Lung Ultrasound for Early Detection of Silent and Apparent aspiratioN in Infants and Young CHildren With Cerebral Palsy and Other Developmental Disabilities: a New Fast, Safe, Cost-effective Infant-friendly Imaging Tool to Easily Monitor Feeding , Improve Outcomes and Reduce Morbidities (LUNCH)","primary_completion_date":"2022-09-15","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-12-15","last_update":"2021-02-10","description":"The aim is to test the effectiveness of lung ultrasound (LUS) in the dynamic assessment of aspiration related to abnormal swallowing in infants and young children with neurological impairment (cerebral palsy/developmental disabilities). Neither standardized measure is available, nor protocols for invasive fibre-optic endoscopic examination of swallowing (FEES) and x-Ray videofluoroscopic swallowing study (VFSS) to be used in such population. LUS offers several advantages: time saving for aspiration diagnosis; safeness (neither invasiveness nor radiation); repeatability with different meal consistencies or to monitor interventions efficacy; cost-effectiveness; savings of x-Ray exposition (compared to VFSS). All these advantages may lead infants to improve clinical behavioural and neurological outcomes and reduce stressful interactions with caregivers, and to reduce morbidities and hospitalization costs for respiratory and non-respiratory complications related to swallowing disorders.","other_id":"LUNCH-2019","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Diagnostic","masking_description":"Triple","intervention_model_description":"Double-blinded randomized parallel-designed controlled trial (Consort checklist, 21), with block randomization (blocks of size 4), in one of 2 groups: 1) LUS-monitored management (LUS-m); 2) Standard care management (SC-m). Both groups will undergo an experimental 6-months follow-up. In the first 3 months, participants will be evaluated a minimum of 1 time per month, in-hospital, for a total of 3 evaluations (T1, T2 and T3), plus baseline (T0).","sampling_method":"","gender":"All","maximum_age":3,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  cerebral palsy or abnormal muscular tone at any age between 0-3 years of life due\r\n             disorders other than cerebral palsy;\r\n\r\n          -  motor developmental delay assessed by a quantitative scale for infants and young\r\n             children development (<5 sd according to age)\r\n\r\n          -  in absence of the previous clinical indices, if there is the clinical suspicion of\r\n             GERD or dysphagia based on clinical symptoms\r\n\r\n          -  a brain MRI acquisition done before or programmed prior the end of the study period as\r\n             part of their diagnostic procedure.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  epileptic spasm\r\n\r\n          -  drugs for muscle tone abnormalities or GERD introduced or modified less than 3 weeks\r\n             before potential enrollment\r\n      ","sponsor":"IRCCS Fondazione Stella Maris","sponsor_type":"Other","conditions":"Cerebral Palsy|Pediatric Neurological Disorder|Developmental Disability","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Lung Ultrasound (LUS)-monitored feeding trial","description":"LUS-monitored (before and after) feeding trial (different consistencies might be tested in separate repeated trials according to clinical evaluation). A further LUS evaluation will be performed at a distance of 3 hours, before the next meal to check for resolution of after-meal abnormalities. All pulmonary fields will be explored according to semeiotics and previous literature."}],"outcomes":[{"outcome_type":"primary","measure":"invasive diagnostic","time_frame":"long term (T4, at 6 months)","description":"VFSS/FEES execution rates"},{"outcome_type":"primary","measure":"invasive diagnostic","time_frame":"short term (T3, at 3 months)","description":"VFSS/FEES execution rates"},{"outcome_type":"secondary","measure":"change from baseline laboratory exam at 6 months","time_frame":"baseline-long term (T4, at 6 months)","description":"blood cells count"},{"outcome_type":"secondary","measure":"change from baseline laboratory exam at 6 months","time_frame":"baseline-long term (T4, at 6 months)","description":"reticulocytes count"},{"outcome_type":"secondary","measure":"parents' stress","time_frame":"long term (T4, at 6 months)","description":"Parenting Stress Index questionnaire (PSI), with scores ranging from 0 to 120 including 4 domains, with higher scores corresponding to worse outcome"},{"outcome_type":"other","measure":"neurological outcome","time_frame":"short term (T3, at 3 months) and long term (T4, at 6 months)","description":"Hammersmith Infant Neurological Examination (HINE), with scores ranging from 0 to 78, with higher scores corresponding to better outcome"},{"outcome_type":"secondary","measure":"change from baseline laboratory exam at 6 months","time_frame":"baseline- long term (T4, at 6 months)","description":"total serum protein"},{"outcome_type":"secondary","measure":"change from baseline laboratory exam at 6 months","time_frame":"baseline- long term (T4, at 6 months)","description":"ferritin"},{"outcome_type":"primary","measure":"respiratory","time_frame":"long term (T4, at 6 months)","description":"respiratory illness rate (including pneumonia, wheezing, chronic cough, and apnoea rate)"},{"outcome_type":"primary","measure":"respiratory","time_frame":"short term (T3, at 3 months)","description":"respiratory illness rate (including pneumonia, wheezing, chronic cough, and apnoea rate)"},{"outcome_type":"primary","measure":"growth","time_frame":"long term (T4, at 6 months)","description":"growth rate"},{"outcome_type":"primary","measure":"growth","time_frame":"short term (T3, at 3 months)","description":"growth rate"},{"outcome_type":"secondary","measure":"chronic pain assessment","time_frame":"short term (T3, at 3 months)","description":"parents-report measure (Non-communicating Children's Pain Checklist, NCCPC), with scores ranging from 0 to 90, with higher scores corresponding to worse outcome"},{"outcome_type":"secondary","measure":"chronic pain assessment","time_frame":"long term (T4, at 6 months)","description":"parents-report measure (Non-communicating Children's Pain Checklist, NCCPC), with scores ranging from 0 to 90, with higher scores corresponding to worse outcome"}]}
{"nct_id":"NCT05008601","start_date":"2021-04-01","enrollment":30,"brief_title":"Aino ECG Ambulatory Study","official_title":"Detection of Cardiac Arrhythmias With Wrist-worn Combined Optical and ECG Based Heart Rate Monitor During Normal Daily Living","primary_completion_date":"2021-08-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2021-12-31","last_update":"2021-08-17","description":"The study includes collection of data from patients referred to a therapeutic evaluation in Tays Sydnkeskus Oy (Heart Center Co, Tampere University Hospital) or another unit of Sydnkeskus (hereafter the Heart Hospital) due to suspected cardiac arrhythmia. Data collection takes place outside the hospital in normal daily conditions. The monitoring is started during the outpatient visit at Heart hospital polyclinic or when leaving home from cardiac ward and it continues for 2 days. Reference information about the occurrence of arrhythmia episodes and the reference ECG data are obtained from simultaneously worn Holter device. During the two days the study device and the reference device are worn continuously. Wearing the devices does not affect the daily routines of the participant except there is no possibility to take a shower. The arrhythmia episodes are labelled in post-hoc signal analysis and annotations visually confirmed by a cardiologist. The participants are instructed to take ECG recordings with the wrist device every time the device gives a notification and also whenever the participant feels arrhythmia symptoms. There will be at least four intermittent ECG records taken on each day.","other_id":"AinoECG_Ambulatory","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":99,"population":"The source population of the study includes patients referred to a therapeutic evaluation\r\n        or treatment in Tays Heart Hospital due to suspected cardiac arrhythmia. A portion (up to\r\n        one third) of the subjects may be having on-going atrial fibrillation at the beginning of\r\n        the measurement and may suffer from persistent or permanent atrial fibrillation.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age:  18 years\r\n\r\n          -  Suspected or earlier diagnosed episodic cardiac arrhythmia, for example atrial\r\n             fibrillation or atrial flutter\r\n\r\n          -  Ability to give informed consent\r\n\r\n          -  Volunteering for the study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Implanted permanent pacemaker\r\n\r\n          -  Inability to give informed consent e.g. due to mental confusion\r\n\r\n          -  Denial\r\n      ","sponsor":"PulseOn Oy","sponsor_type":"Industry","conditions":"Arrhythmias, Cardiac|Atrial Fibrillation and Flutter","interventions":[{"intervention_type":"Device","name":"Device: Wrist-word optical heart rate and ECG measurement device","description":"Aino ECG: wrist-word optical heart rate and ECG measurement device"}],"outcomes":[{"outcome_type":"primary","measure":"Verification that the atrial fibrillation detection sensitivity satisfies the design input requirements defined for the Aino ECG device","time_frame":"6 months"},{"outcome_type":"primary","measure":"Verification that the data accuracy (accuracy of optically measured inter-beat-intervals) satisfies the design input requirement defined for the Aino ECG device.","time_frame":"6 months"},{"outcome_type":"primary","measure":"Verification that the quality of the ECG signal measured with Aino ECG satisfies the design input requirement defined for the Aino ECG device.","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Showing that the quality of the measured PPG signal is similar enough compared with the one measured with the earlier prototype","time_frame":"6 months"},{"outcome_type":"secondary","measure":"To obtain feedback regarding the usability of the Aino ECG wrist device","time_frame":"6 months","description":"The feedback is obtained with feedback form filled by the study participants. The form includes questions regarding: overall impression on the study device, easiness of noticing and interpret the notifications of the device, comfortability of using the device, easiness of adjusting the tightness of the wrist band, and operation of the intermittent ECG measurements."}]}
{"nct_id":"NCT04917744","start_date":"2021-04-01","enrollment":15,"brief_title":"Metabolite Levels in Ovarian Cancer Patients Receiving Maintenance PARP Inhibitors","official_title":"Longitudinal Metabolite Levels in Patients Receiving Maintenance PARP Inhibitors","primary_completion_date":"2023-03-19","study_type":"Observational","rec_status":"Recruiting","completion_date":"2024-03-19","last_update":"2021-06-18","description":"This study evaluates blood samples and compares levels of metabolites (levels of vitamins, carbohydrates, proteins, etc., that are in the blood), before and after the plasma exchange in patients scheduled to receive immunotherapy for their ovarian cancer. The information gained from this study may help researchers better understand the side effects from each treatment and possibly lessen those side effects for future treatments.","other_id":"20-013191","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"Female","population":"Patients with melanoma scheduled to receive immunotherapy for their ovarian cancer.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adults\r\n\r\n          -  Patients with ovarian cancer starting PARP inhibitor treatment\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients unwilling to return for blood draws, patients unwilling to continue PARP\r\n             inhibitor treatment for at least one month\r\n      ","sponsor":"Mayo Clinic","sponsor_type":"Other","conditions":"Ovarian Carcinoma","interventions":[{"intervention_type":"Procedure","name":"Procedure: Biospecimen Collection","description":"Undergo collection of blood samples"},{"intervention_type":"Other","name":"Other: Laboratory Biomarker Analysis","description":"Ancillary studies"},{"intervention_type":"Other","name":"Other: Medical Chart Review","description":"Review of medical charts"}],"outcomes":[{"outcome_type":"primary","measure":"Change of mesenchymal stem cell (MSC)-derived cancer support factors","time_frame":"At four weeks post PARP inhibitor treatment","description":"Levels of MSC-derived cancer support factors will be compared to baseline (i.e. pre-PARPi therapy) at each collection time point by Student's t test. In addition, outcomes by Cox proportional hazards will be compared between designated responders (i.e. patients whose MSC-derived cancer support factors decreased after PARP inhibition) and non-responders (i.e. patients whose MSC-derived cancer support factors did not decrease after PARP inhibition)"},{"outcome_type":"secondary","measure":"Progression-free survival","time_frame":"Up to 2 years","description":"Stratified by extent of MSC-derived cancer support factor reduction. Will also compare levels at progression and/or after discontinuation of therapy."}]}
{"nct_id":"NCT04761614","start_date":"2021-04-01","phase":"Phase 1","enrollment":15,"brief_title":"Riluzole in Combination With mFOLFOX6 and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer","official_title":"A Phase I Study of Riluzole in Combination With mFOLFOX6/Bevacizumab in Patients With Metastatic Colorectal Cancer","primary_completion_date":"2023-12-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2024-12-31","last_update":"2021-02-21","description":"This phase I trial is to find out the best dose, possible benefits, and/or side effects of riluzole and how well it works in combination with standard of care mFOLFOX6 and bevacizumab in treating patients with colorectal cancer that has spread to other places in the body (metastatic). Riluzole is a well-tolerated oral medication that has demonstrated it may make chemotherapy work better. Chemotherapy drugs, such as oxaliplatin, leucovorin calcium and fluorouracil, work in different ways to stop the growth of [cancer/tumor] cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab is an antibody that targets the blood vessel by blocking the activity of a protein called vascular endothelial growth factor alpha (VEGF-A). It helps to make the mFOLFOX6 more effective. Giving riluzole, mFOLFOX6, and bevacizumab may kill more tumor cells compared to mFOLFOX6 and bevacizumab alone in treating patients with colorectal cancer.","other_id":"OSU-20096","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with metastatic colorectal cancer, who are appropriate candidates to receive\r\n             mFOLFOX6/bevacizumab. Patients who progressed on FOLFOX-based regimen are allowed\r\n\r\n          -  Willingness to undergo both pre-treatment and post-treatment tumor tissue biopsies\r\n             (pre-treatment tumor tissue will be sent to pathology lab to confirm metastatic\r\n             colorectal cancer as the standard of care)\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1\r\n\r\n          -  Age >= 18 years\r\n\r\n          -  Absolute neutrophil count >= (ANC) 1,500/ul\r\n\r\n          -  Platelets >= 100,000/ul\r\n\r\n          -  Hemoglobin >= 9 g/dl\r\n\r\n          -  Serum total bilirubin < 1.5 x ULN\r\n\r\n          -  Serum albumin >= 2.5 g/dl\r\n\r\n          -  If no liver involvement, aspartate aminotransferase (AST) and alanine aminotransferase\r\n             (ALT) =< 1.5 x ULN. If liver involvement, AST and ALT =< 3.0 x ULN\r\n\r\n          -  Ability to understand and the willingness to sign a written informed consent document\r\n\r\n          -  A male subject of fathering potential must use an adequate method of contraception to\r\n             avoid conception throughout the study (and for up to 12 weeks after the last dose of\r\n             study drug) to minimize the risk of pregnancy. If the partner is pregnant or\r\n             breastfeeding, the subject must use a condom\r\n\r\n          -  Women of childbearing potential (WOCBP) must be using an adequate method of\r\n             contraception to avoid pregnancy throughout the study and for up to 12 weeks after the\r\n             last dose of study drug to minimize the risk of pregnancy. WOCBP must have a negative\r\n             serum or urine pregnancy test within 72 hours before the start of the investigational\r\n             product\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who are receiving any other investigational agents\r\n\r\n          -  Patients with history of hepatitis B or C\r\n\r\n          -  Patients with severe renal impairment (CrCl < 30 mL/min)\r\n\r\n          -  Prior full field radiotherapy < 4 weeks or limited field radiotherapy < 2 weeks prior\r\n             to first study drug administration. Patients with central nervous system (CNS)\r\n             metastases may participate in this trial provided they are clinically stable. Patients\r\n             who are < 1 month from radiation therapy must not be included\r\n\r\n          -  Patients with existing grade 2 peripheral neuropathy\r\n\r\n          -  Patients with a history of thrombotic or embolic events within the last six months\r\n             such as a cerebrovascular accident (including transient ischemic attacks), pulmonary\r\n             embolism or deep vein thrombosis\r\n\r\n          -  Cardiac conditions as follows:\r\n\r\n               -  Active coronary artery disease, unstable or newly diagnosed angina or myocardial\r\n                  infarction less than 6 months prior to first study drug administration\r\n\r\n               -  Class III-IV New York Heart Association (NYHA) congestive heart failure\r\n\r\n               -  Uncontrolled hypertension (Systolic blood pressure [BP] > 150 mmHg and diastolic\r\n                  BP > 90 mmHg for 24 hours) despite optimal medical management\r\n\r\n               -  Corrected QT (QTc) (Friderica) prolongation > 480 msec\r\n\r\n          -  Uncontrolled concurrent illness including, but not limited to, ongoing or active\r\n             infection, cardiac arrhythmia, active bleeding diatheses, and psychiatric\r\n             illness/social situations that would limit compliance with study requirements\r\n\r\n          -  Major surgical procedure or significant traumatic injury less than 3 weeks or those\r\n             who receive minor surgical procedures within 1 week from first dose of study drug\r\n             administration\r\n\r\n          -  Known inability to swallow capsules\r\n\r\n          -  Inability to comply with study and/or follow-up procedures\r\n\r\n          -  Pregnant women are excluded from this study. Because there is an unknown but potential\r\n             risk for adverse events in nursing infants secondary to treatment of the mother,\r\n             breastfeeding should be discontinued\r\n      ","sponsor":"Ning Jin","sponsor_type":"Other","conditions":"Metastatic Colorectal Carcinoma|Stage IV Colorectal Cancer AJCC v8|Stage IVA Colorectal Cancer AJCC v8|Stage IVB Colorectal Cancer AJCC v8|Stage IVC Colorectal Cancer AJCC v8","interventions":[{"intervention_type":"Biological","name":"Biological: Bevacizumab","description":"Given IVPB"},{"intervention_type":"Drug","name":"Drug: Fluorouracil","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: Leucovorin Calcium","description":"Given IVPB"},{"intervention_type":"Drug","name":"Drug: Oxaliplatin","description":"Given IVPB"},{"intervention_type":"Drug","name":"Drug: Riluzole","description":"Given PO"}],"outcomes":[{"outcome_type":"other","measure":"Objective response rate (complete response + partial response)","time_frame":"Up to 112 days","description":"Will be estimated along with exact 95% confidence interval."},{"outcome_type":"primary","measure":"Dose limiting toxicities (DLTs)","time_frame":"Up to 4 weeks (2 cycles of treatment) (1 cycle = 14 days)","description":"Will be defined by treatment related grade >= 4 adverse events or >= grade 3 alanine aminotransferase or aspartate aminotransferase elevation during the DLT period using the Common Terminology Criteria for Adverse Events version 5.0."},{"outcome_type":"secondary","measure":"Pharmacokinetic (PK) profile of riluzole (Cmax)","time_frame":"Day 1 on cycle 1 (each cycle is 14 days)","description":"K data analysis will utilize a nonlinear mixed effects approach whereby PK parameter estimates will be generated from the data, and 'dose day' will be evaluated as a covariate on clearance and volume of distribution. The PK parameters including Cmax. Peak Plasma Concentration (Cmax)"},{"outcome_type":"secondary","measure":"Pharmacokinetic (PK) profile of riluzole (AUC)","time_frame":"Day 1 on cycle 1 (each cycle is 14 days)","description":"PK data analysis will utilize a nonlinear mixed effects approach whereby PK parameter estimates will be generated from the data, and 'dose day' will be evaluated as a covariate on clearance and volume of distribution. The PK parameters including AUC. Area under the plasma concentration versus time curve (AUC)"},{"outcome_type":"other","measure":"Change in phosphorylated (p)AKT and pCREB levels","time_frame":"Up to 42 days (each cycle is 14 days)","description":"Will be summarized using mean +/- standard error of mean, range, and median at each time point. Graphical analyses will be largely used to assess potential patterns and relationships."},{"outcome_type":"other","measure":"Change in FCGRT/FcRn expression","time_frame":"Day 1 of cycle 1, 3, 5, 7 (each cycle is 14 days)","description":"Will be assessed using peripheral blood and summarized using mean +/- standard error of mean, range, and median at each time point. Graphical analyses will be largely used to assess potential patterns and relationships."},{"outcome_type":"other","measure":"Change in bevacizumab clearance (Cmax)","time_frame":"Day 1 of cycle 1, 3, 5, 7 (each cycle is 14 days)","description":"Peak Plasma Concentration (Cmax)"},{"outcome_type":"other","measure":"Change in bevacizumab clearance (AUC)","time_frame":"Day 1 of cycle 1, 3, 5, 7 (each cycle is 14 days)","description":"Area under the plasma concentration versus time curve (AUC)"},{"outcome_type":"other","measure":"interleukin 6","time_frame":"Day 1 of cycle 1 and day 1 of cycle 7 (each cycle is 14 days)","description":"Cytokines"},{"outcome_type":"other","measure":"leukemia inhibitory factor","time_frame":"Day 1 of cycle 1 and day 1 of cycle 7 (each cycle is 14 days)","description":"Cytokines"},{"outcome_type":"other","measure":"Necrosis factor alpha","time_frame":"Day 1 of cycle 1 and day 1 of cycle 7 (each cycle is 14 days)","description":"Cytokines"},{"outcome_type":"other","measure":"Interferon gamma","time_frame":"Day 1 of cycle 1 and day 1 of cycle 7 (each cycle is 14 days)","description":"Cytokines"},{"outcome_type":"other","measure":"C-reactive protein","time_frame":"Day 1 of cycle 1 and day 1 of cycle 7 (each cycle is 14 days)","description":"Cytokines"},{"outcome_type":"other","measure":"ferritin","time_frame":"Day 1 of cycle 1 and day 1 of cycle 7 (each cycle is 14 days)","description":"Cytokines"},{"outcome_type":"other","measure":"metalloproteinases 1","time_frame":"Day 1 of cycle 1 and day 1 of cycle 7 (each cycle is 14 days)","description":"Cytokines"},{"outcome_type":"other","measure":"body weight","time_frame":"Day 1 of cycle 1 and day 1 of cycle 7 (each cycle is 14 days)","description":"Will include body weight and summarized using mean +/- standard error of mean, range, and median at each time point. Graphical analyses will be largely used to assess potential patterns and relationships."},{"outcome_type":"other","measure":"skeletal muscle index","time_frame":"Day 1 of cycle 1 and day 1 of cycle 7 (each cycle is 14 days)","description":"Will include skeletal muscle index and summarized using mean +/- standard error of mean, range, and median at each time point. Graphical analyses will be largely used to assess potential patterns and relationships."},{"outcome_type":"other","measure":"body serum albumin","time_frame":"Day 1 of cycle 1 and day 1 of cycle 7 (each cycle is 14 days)","description":"Will include body serum albumin and summarized using mean +/- standard error of mean, range, and median at each time point. Graphical analyses will be largely used to assess potential patterns and relationships."},{"outcome_type":"other","measure":"Change in levels of circulating cytotoxic T cells","time_frame":"Day 1 of Cycle 1,3,5,7 (each cycle is 14 days)","description":"Will be assessed using peripheral blood mononuclear cells and summarized using mean +/- standard error of mean, range, and median at each time point. Graphical analyses will be largely used to assess potential patterns and relationships."}]}
{"nct_id":"NCT04812236","start_date":"2021-04-01","phase":"Phase 4","enrollment":320,"brief_title":"Clinical Study on Wuling Powder in Treating Metabolic Syndrome of Spleen Deficiency and Dampness","official_title":"A Randomized, Partially Double-blind, Controlled, Multi-center Clinical Study of Wulingsan Single Decoction Granules Combined With Conventional Therapy in the Treatment of Metabolic Syndrome of Spleen Deficiency, Dampness and Sleepiness","primary_completion_date":"2023-02-28","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2023-05-01","last_update":"2021-03-23","description":"In this study, a randomized, partially double-blind, controlled, multi-center clinical research method was used. A total of 4 groups were designed, namely, single decoction group, co-decoction group, powder group and simulation group. The four groups of patients all received basic health education, diet control and increased exercise guidance. All the patients in the group have taken western medicine according to their own conditions and followed the doctor's instructions for hypoglycemic, blood pressure, and lipid-lowering treatments. After joining the group, they continue to take the medicine at the original dose, and the patients are advised not to change the medicine during the observation period. Take 12 weeks as a course of treatment, and set the observation period to 12 weeks. Follow up every 4 weeks.","other_id":"FM-P8-2018052801","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patients who meet the diagnostic criteria of metabolic syndrome;\r\n\r\n          2. TCM syndrome differentiation of spleen deficiency and dampness patients;\r\n\r\n          3. Patients with phlegm-dampness constitution score>30;\r\n\r\n          4. Patients aged 18 to 70 years;\r\n\r\n          5. Patients who have signed informed consent and are highly compliant.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients with hypertension, hyperglycemia, and hyperlipidemia caused by secondary\r\n             metabolic syndrome (disease, drugs, surgery, etc.);\r\n\r\n          2. Patients with severe primary diseases such as heart, liver, kidney, lung, brain,\r\n             endocrine, hematopoietic system in the past or at the time of enrollment;\r\n\r\n          3. Those who are confirmed to have acute coronary syndrome, malignant arrhythmia, and\r\n             other serious heart diseases;\r\n\r\n          4. Patients with co-infection, malignant tumors or mental illness;\r\n\r\n          5. Patients with Cushing syndrome;\r\n\r\n          6. Patients with allergies or allergies to this drug;\r\n\r\n          7. Pregnant or breastfeeding women;\r\n\r\n          8. Those who have adjusted hypoglycemic, lipid-lowering, antihypertensive drugs or taking\r\n             weight-loss drugs within 1 month before enrollment.\r\n      ","sponsor":"Jiangsu Famous Medical Technology Co., Ltd.","sponsor_type":"Industry","conditions":"Metabolic Syndrome","interventions":[{"intervention_type":"Drug","name":"Drug: Wulingsan single decoction granules","description":"Wulingsan single decoction granules, the prescription is Alisma, Polyporus, Atractylodes, Poria, Guizhi. Oral, 2 times a day, 2 sachets each time, rinsed with warm water"},{"intervention_type":"Drug","name":"Drug: Wulingsan co-decoction granules","description":"Wulingsan co-decoction granules, the prescription is Alisma, Polyporus, Atractylodes, Poria, Guizhi. Oral, 2 times a day, 2 sachets each time, rinsed with warm water"},{"intervention_type":"Drug","name":"Drug: Wuling Powder","description":"Wuling powder is composed of Alisma, Polyporus, Atractylodes, Poria, Guizhi. 2 times a day, 5g each time, take it with warm water"},{"intervention_type":"Drug","name":"Drug: Wulingsan granule simulant","description":"Wulingsan granule simulant, the prescription is Alisma, Polyporus, Atractylodes, Poria, Guizhi. Oral, 2 times a day, 2 sachets each time, rinsed with warm water"}],"outcomes":[{"outcome_type":"primary","measure":"Analysis of changes in waist-to-hip ratio at 12 weeks","time_frame":"12 weeks","description":"Measure and record the waist-to-hip ratio of the patient before and after treatment"},{"outcome_type":"primary","measure":"Analysis of body mass index changes in 12 weeks","time_frame":"12 weeks","description":"Measure and record the patient's BMI before and after treatment"},{"outcome_type":"secondary","measure":"Improvement of the conversion score of phlegm-damp constitution judgment","time_frame":"12 weeks","description":"To study the improvement of the conversion score of phlegm-damp constitution before and after treatment"},{"outcome_type":"secondary","measure":"Lipid Index","time_frame":"4 weeks，8 weeks，12 weeks","description":"Investigate the changes in triglycerides, high-density lipoprotein cholesterol, cholesterol and low-density lipoprotein cholesterol during treatment"},{"outcome_type":"secondary","measure":"Fasting blood glucose index","time_frame":"4 weeks，8 weeks，12 weeks","description":"Investigate changes in fasting blood glucose during treatment"},{"outcome_type":"secondary","measure":"2h blood glucose after meal","time_frame":"4 weeks，8 weeks，12 weeks","description":"Investigate changes in 2h blood glucose after meal during treatment"},{"outcome_type":"secondary","measure":"HOMAA insulin resistance index","time_frame":"12 weeks","description":"To investigate the changes of HOMAA insulin resistance index during treatment"},{"outcome_type":"secondary","measure":"Blood pressure index","time_frame":"4 weeks，8 weeks，12 weeks","description":"Observe the changes in systolic and diastolic blood pressure during treatment"},{"outcome_type":"secondary","measure":"Inflammatory factors","time_frame":"12 weeks","description":"Investigate the changes of hypersensitivity C-reactive protein and endotoxin during treatment"}]}
{"nct_id":"NCT04620538","start_date":"2021-04-01","enrollment":500,"brief_title":"Volatile Organic Compounds for the Assessment of Liver Disease","official_title":"Volatile Organic Compounds for the Assessment of Liver Disease: Assessment of Hepatobiliary Disease Through Non-Invasive Detection of Exhaled Volatile Organic Compounds","primary_completion_date":"2022-06-30","study_type":"Observational","rec_status":"Recruiting","completion_date":"2022-09-30","last_update":"2021-09-05","description":"This study aims to determine whether a breath test could be used for early detection of hepatic fibrosis, cirrhosis or hepatocellular carcinoma. Patients who are attending for a planned liver outpatient services or investigations will be approached to provide a breath sample. Multi platform mass spectrometry analysis will be performed to establish volatile biomarkers that can discriminate between fibrosis, cirrhosis and hepatocellular carcinoma.","other_id":"19SM5129","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":90,"population":"Patients will be identified and recruited from Imperial College Healthcare NHS Trust\r\n        inpatient admissions, routine outpatient hepatobiliary clinics, the radiology departments\r\n        (e.g. for patients undergoing liver biopsy or imaging of their liver) and endoscopy units\r\n        (e.g. liver disease patients undergoing endoscopic surveillance for varices). Patients with\r\n        hepatocellular carcinoma may also be recruited from oncology outpatient clinics.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients seen in secondary care with suspected or confirmed liver / pancreatic disease\r\n             or hepatocellular carcinoma / pancreatic cancer\r\n\r\n          -  Patients able to understand and retain the information provided, thereby being able to\r\n             give informed consent for inclusion in this study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who lack capacity or unable to provide informed consent.\r\n\r\n          -  Any patient outside the established age range (18-90years).\r\n\r\n          -  Patients unable to fast.\r\n      ","sponsor":"Imperial College London","sponsor_type":"Other","conditions":"Cirrhosis|Cirrhosis, Liver|Fibrosis, Liver|Hepatocellular Carcinoma|Hepatocellular Cancer","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Breath Analysis","description":"Participants will be asked to provide 500mls of exhaled breath which will be loaded on to thermal desorption tubes and analysed via Mass Spectrometry."}],"outcomes":[{"outcome_type":"primary","measure":"Determine the diagnostic accuracy of breath test for detection of fibrosis, cirrhosis or hepatocellular carcinoma.","time_frame":"24 months","description":"Diagnostic accuracy will be measured by calculating the sensitivity and specificity of the test for detection of fibrosis / cirrhosis / hepatocellular carcinoma. Sensitivity and specificity values are represented by a number between 0 to 1 indicating the test's ability to pick up true positive results and true negative results respectively, where a number closer to one indicates a greater detection ability."}]}
{"nct_id":"NCT04732611","start_date":"2021-03-31","phase":"N/A","enrollment":60,"brief_title":"Effects of Pilates Exercises Versus Walking on Mechanical and Vascular Variables of Individuals With Type 2 Diabetes Mellitus","official_title":"Effects of Pilates Exercises Versus Walking on Mechanical and Vascular Variables of Individuals With Type 2 Diabetes Mellitus: Randomized Clinical Trial","primary_completion_date":"2021-04-30","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2022-08-31","last_update":"2021-02-01","description":"The Diabetes Mellitus (DM) is a major worldwide public health problem. The hyperglycemia resulting from DM could lead to metabolic adaptations and physiological changes in different body systems. The DM patients are usually sedentary, once the symptoms as the sensory deficits compromise balance and gait. Giving that this sedentary lifestyle needs to be reversed, since physical exercise is well known a fundamental element in the treatment and prevention of the DM. The major recommendations to this population is the practice of aerobic exercises and the strength training focused on the biggest muscle groups. It is well know that this type of exercise can improve the uptake of intramuscular glucose. In that context the Pilates Method seems as a good option of exercise, once the method works in a global way, working on different muscle groups in the same exercise. Besides that, to the best of our knowledge there aren't enough studies to support the Pilates Method as an alternative type exercise to help in the glycemic control and in the management of this kind of patients. The aim of this study is to evaluate the efficacy and safety of an exercise program using the Pilates Method versus a walking program in neuromuscular, metabolic and vascular variables in type 2 diabetic patients. 60 participants will be recruited by convenience. Individuals will be eligible if [1] they had type 2 diabetes mellitus; [2] men and women aged 35 to 60 years [3] medical approval to practice exercise; [4] do not have any bone, joint or muscle disease that make the practice of exercises impossible; [5] not being pregnant; [6] not being unable to follow the instructions for any reason and [7] at least 6 months without exercising. The participants' eligibility will be checked by the researcher. Subsequently, they will be allocated randomly in one of the two groups (Pilates Group or Walking). Pilates group participants will perform 3 Pilates sessions a week lasting approximately 50 minutes for 20 weeks. Walking group participants will perform 3 walking sessions a week lasting approximately 50 minutes for 20 weeks. All the exercises sessions will be supervised by a professional. All the participants will be evaluated at the baseline and after 20 weeks of exercises. The main outcome of this study are the Triceps surae muscle force and the blood glycose. The secondary outcomes are Triceps surae muscle architecture, mechanical adaptations of the Achilles tendon and endothelial function. Our hypothesis is that both groups will be safety and efficiency to improve the Triceps surae muscle force and to decrease blood glycose. Our secondary hypothesis is that the Pilates Group will show better results to both primary outcomes than the walking group.","other_id":"39137","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":35,"maximum_age":65,"population":"","criteria":"\n        Criteria:\r\n\r\n        Inclusion Criteria:\r\n\r\n          -  Men and women between 35 and 65 years old;\r\n\r\n          -  Possess type 2 diabetes mellitus diagnosed;\r\n\r\n          -  Medical approval to practice exercise;\r\n\r\n          -  Do not have any bone, joint or muscle disease that make impossible do the exercises;\r\n\r\n          -  not being pregnant;\r\n\r\n          -  not being unable to follow the instructions for any reason;\r\n\r\n          -  not be exercising for at least 6 months.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Incapacity to follow the instructions for any reason;\r\n\r\n          -  Beginning another treatment for DM2, either physical therapy, exercises or changes of\r\n             the medical care throughout the study period.\r\n\r\n          -  Having practiced exercises in the last six months;\r\n\r\n          -  Pregnancy;\r\n      ","sponsor":"Federal University of Rio Grande do Sul","sponsor_type":"Other","conditions":"Diabetes Mellitus, Type 2","interventions":[{"intervention_type":"Other","name":"Other: Pilates exercises","description":"Pilates group participants will perform 3 weekly Pilates sessions lasting approximately 50 minutes for 20 weeks."},{"intervention_type":"Other","name":"Other: Walking protocol","description":"Walking group participants will perform 3 weekly walking sessions lasting approximately 50 minutes for 20 weeks."}],"outcomes":[{"outcome_type":"primary","measure":"Triceps surae muscle force","time_frame":"20 weeks","description":"Triceps surae muscle force assessed by isokinetic dynamometry."},{"outcome_type":"primary","measure":"Blood Glycose","time_frame":"20 weeks","description":"Blood Glycose assessed by HbA1c"},{"outcome_type":"secondary","measure":"Triceps surae muscle architecture","time_frame":"20 weeks","description":"Triceps surae muscle architecture assessed by ultrasound"},{"outcome_type":"secondary","measure":"Mechanical adaptations of the Achilles tendon","time_frame":"20 weeks","description":"Mechanical adaptations of the Achilles tendon assessed by ultrasound"},{"outcome_type":"secondary","measure":"Endothelial function","time_frame":"20 weeks","description":"Endothelial function assessed by ultrasound"}]}
{"nct_id":"NCT04782219","start_date":"2021-03-31","enrollment":100,"brief_title":"Validity of Turkish Version of PROMIS-29 Measure","official_title":"Reliability and Validity of the Turkish Version of Patient-Reported Outcomes Measurement Information System-29 in Individuals With Musculoskeletal Diseases","primary_completion_date":"2021-04-30","study_type":"Observational","rec_status":"Not yet recruiting","completion_date":"2021-05-31","last_update":"2021-03-04","description":"This study will be carried out on 100 patients with chronic musculoskeletal disorders who applied to Acbadem Maslak Hospital Orthopedics and Traumatology Department. Demographic information (age, education level, occupation, marital status) will be obtained from the patients, they will be asked whether they have a chronic musculoskeletal disease diagnosed by the doctor, and they will be asked to fill in the PROMIS 29 and SF-36 v2 questionnaires. The PROMIS 29 questionnaire contains 4 questions from each of the seven contents of PROMIS (physical function, depression, anxiety, fatigue, sleep disorder, participation in social activities and pain interaction) and 1 question from the intensity of pain. Each item has 5 answer options (from 1 to 5), only pain intensity has 11 answer options (from 0 to 10). From the sum of the answers to each question in the domain, the total raw score for each domain is calculated, resulting in seven domain scores, each between 4 and 20. SF-36 is the most widely used scale to assess general health status, and 36 items question 8 content (physical function, physical role, pain, general health, social function, energy / fitness, social function, emotional role, mental health). The Turkish translation of the PROMIS 29 questionnaire is presented in ANNEX-2. The translation of the PROMIS 29 questionnaire into Turkish was made by Northwestern University according to the FACIT translation method. Its Turkish translation was obtained from Northwestern University by signing a license agreement for use in scientific research. Participants will first be asked to sign the informed consent form electronically. PROMIS 29 and SF-36 v2 forms will be sent to the volunteers via e-mail and will be asked to respond via an internet-based questionnaire platform. The external validity of the PROMIS 29 questionnaire will be evaluated by its correlation with the SF-36 v2, a similar general health profile questionnaire. To evaluate inter-rater test-retest reliability, both scales will be filled in by patients a second time between 7-14 days.","other_id":"AcibademH","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":80,"population":"Persons who applied to the Acibadem Maslak Hospital Orthopedics and Traumatology department\r\n        and were diagnosed with a chronic musculoskeletal disease by orthopedists will be included\r\n        in the study.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Being over the age of 18,\r\n\r\n          -  To be able to read and speak Turkish,\r\n\r\n          -  To have a chronic musculoskeletal disease\r\n\r\n          -  volunteering to participate in the study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  To have serious medical conditions or complications (such as vision or hearing\r\n             impairments) that may affect the participant's ability to respond to study\r\n             questionnaires\r\n      ","sponsor":"Baheehir University","sponsor_type":"Other","conditions":"Musculoskeletal Diseases","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Patient Reported Outcome Measures Information System-29 (PROMIS-29)","time_frame":"It will be filled for the second time between 7-14 days.","description":"The PROMIS 29 questionnaire contains 4 questions from each of seven PROMIS contents (physical function, depression, anxiety, fatigue, sleep disorder, participation in social activities and pain interaction) and 1 question from the intensity of pain. Each item has 5 answer options (from 1 to 5), only pain intensity has 11 answer options (from 0 to 10). From the sum of the answers to each question in the domain, the total raw score for each domain is calculated, resulting in seven domain scores, each between 4 and 20."},{"outcome_type":"primary","measure":"Short Form-36 (SF-36)","time_frame":"It will be filled for the second time between 7-14 days.","description":"SF-36 is the most widely used scale to assess general health status, and 36 items question 8 content (physical function, physical role, pain, general health, social function, energy / fitness, social function, emotional role, mental health)"}]}
{"nct_id":"NCT04658511","start_date":"2021-03-31","phase":"N/A","enrollment":25,"brief_title":"Presence of the Arcade of Struthers on Preoperative Ultrasound","official_title":"Correlation Between the Presence of the Arcade of Struthers on Preoperative Ultrasound and During Endoscopic Surgery","primary_completion_date":"2021-05-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2021-07-31","last_update":"2021-03-19","description":"To determine the correlation between the presence of the arcade of Struthers on preoperative ultrasound and during endoscopic surgery for cubital tunnel syndrome, and to determine the reliability of a portable ultrasound probe to detect the arcade of Struthers in the arm.","other_id":"20.1097","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":99,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosis of Cubital tunnel syndrome\r\n\r\n          -  Planned for endoscopic cubital tunnel release primary surgery\r\n\r\n          -  >=18 years of age\r\n\r\n          -  no previous arm or elbow surgeries\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Revision surgery\r\n\r\n          -  Planned for open cubital tunnel release\r\n\r\n          -  Prior surgical intervention around the arm or the elbow\r\n\r\n          -  <18 years of age\r\n      ","sponsor":"Christine M. Kleinert Institute for Hand and Microsurgery","sponsor_type":"Other","conditions":"Cubital Tunnel Syndrome","interventions":[{"intervention_type":"Device","name":"Device: Ultrasound","description":"On the spot, during the pre-op clinic visit, an ultrasound exam will be done by the PI trying to visualize the arcade of Struthers"}],"outcomes":[{"outcome_type":"primary","measure":"Presence of the arcade of Struthers","time_frame":"through study completion, average of 1 day/visit","description":"Presence/visualization of the arcade of Struthers with ultrasound"}]}
{"nct_id":"NCT04744779","start_date":"2021-03-31","phase":"N/A","enrollment":40,"brief_title":"Office Based Vergence/Accommodative Therapy for the Treatment of Intermittent Exotropia","official_title":"Effectiveness of Office Based Vergence/Accommodative Therapy for the Treatment of Intermittent Exotropia: A Randomized Clinical Trial","primary_completion_date":"2023-06-30","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2023-06-30","last_update":"2021-02-23","description":"Effectiveness of office based vergence/accommodative therapy for the treatment of intermittent exotropia is investigated through a randomized clinical trial","other_id":"XT4","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":6,"maximum_age":17,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. 6 to <18 years old\r\n\r\n          2. Distance exodeviation between 10 and 30 prism diopters (PD) measured by prism and\r\n             alternate cover test (PACT)\r\n\r\n          3. Near deviation not exceeding the distance deviation by >10PD by PACT (i.e.,\r\n             convergence insufficiency type intermittent exotropia excluded)\r\n\r\n          4. Control of deviation meeting all the following criteria based on the office control\r\n             score scale:\r\n\r\n             4.1 Intermittent or constant exotropia at distance (mean of 3 baseline assessments of\r\n             distance control  Grade 2)# 4.2 Intermittent exotropia or exophoria at near (at least\r\n             1 of 3 assessments of near control at the baseline visit Grade 0-4) or orthophoria\r\n\r\n          5. Stereoacuity: near stereoacuity of 400 arcsec or better by the Preschool Randot\r\n             stereotest\r\n\r\n          6. Cycloplegic subjective refraction spherical equivalent (SE) refractive error between\r\n             -6.00 diopters (D)and +3.50 D inclusive in either eye\r\n\r\n          7. Must be wearing the updated refractive correction (spectacles) for at least 2 weeks if\r\n             refractive error (based on cycloplegic subjective refraction performed within 6\r\n             months) meets any of the following:\r\n\r\n             7.1 Myopia >-0.50 D spherical equivalent in either eye 7.2 Anisometropia >1.00 D\r\n             spherical equivalent 7.3 Astigmatism in either eye >1.50 D\r\n\r\n          8. Refractive correction must meet the following guidelines:\r\n\r\n             8.1 Anisometropia spherical equivalent must be within 0.25 D of the full anisometropic\r\n             difference 8.2 Astigmatism cylinder must be within 0.25 D of full correction and axis\r\n             must be within 5 degree 8.3 For hyperopia and myopia, the spherical component can be\r\n             reduced by investigator discretion provided reduction is symmetrical and results in\r\n             residual (i.e., uncorrected) spherical equivalent refractive error that does not\r\n             exceed +3.50 D spherical equivalent hyperopia or -0.50 D spherical equivalent myopia\r\n\r\n          9. Gestational age >34 weeks\r\n\r\n         10. Birth weight >1500 g\r\n\r\n         11. No previous surgical or nonsurgical treatment for intermittent exotropia other than\r\n             single vision refractive correction (e.g. progressive addition lens, bifocals,\r\n             patching, or deliberate over-minus with spectacles >0.50 D)\r\n\r\n         12. No prior office-based vision therapy for any reason\r\n\r\n         13. No prior strabismus surgery or botulinum injection, intraocular surgery, or refractive\r\n             surgery\r\n\r\n         14. No planned strabismus surgery\r\n\r\n         15. Visual acuity correctable to at least 20/25 or better at distance and near in each\r\n             eye.\r\n\r\n               -  Inclusion criteria 4.1 may be changed to \"Intermittent or constant exotropia at\r\n                  distance (mean of 3 baseline assessments of distance control  Grade 1\" if there\r\n                  is difficulty in patient recruitment.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Amblyopia, nystagmus, restrictive or paretic strabismus\r\n\r\n          2. Regular use of any ocular or systemic medications known to affect accommodation or\r\n             vergence system, such as atropine, pirenzepine, and anti-epileptic medications, in the\r\n             most recent 3 months\r\n\r\n          3. Developmental disability, attention-deficit/hyperactivity disorder (ADHD), or learning\r\n             disability diagnosis in children that in the investigator's discretion would interfere\r\n             with office-based treatment\r\n\r\n          4. Relocation anticipated within 2 year\r\n\r\n          5. Significant ocular or neurologic disorders (e.g. cerebral palsy) other than strabismus\r\n\r\n          6. Vertical deviation greater than 3 pd\r\n\r\n          7. Household member already in the study\r\n      ","sponsor":"Sun Yat-sen University","sponsor_type":"Other","conditions":"Intermittent Exotropia","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Office-based accommodative/vergence therapy and home reinforcement","description":"Office-based accommodative/vergence therapy (60 minutes per visit, one time per week, 16 weeks) and home reinforcement (15 minutes each time, five times per week, 16 weeks)"}],"outcomes":[{"outcome_type":"primary","measure":"Comparison of the distant office control score between two groups at the primary outcome visit","time_frame":"16 months","description":"Comparison of the distant office control score between two groups at the primary outcome visit"},{"outcome_type":"secondary","measure":"Comparison of percentage of patients showing ≥ 1 point change and ≥ 2 points change in office control score","time_frame":"16 months","description":"Comparison of percentage of patients showing ≥ 1 point change and ≥ 2 points change in office control score"},{"outcome_type":"other","measure":"Comparison of deterioration rate between 2 groups","time_frame":"16 months","description":"Comparison of deterioration rate between 2 groups"}]}
{"nct_id":"NCT04841174","start_date":"2021-03-30","phase":"N/A","enrollment":40,"brief_title":"The Effect of Abdominal Massage on Gastric Problems in Pediatric Intensive Care: A Randomized Controlled Study","official_title":"The Effect of Abdominal Massage on Gastric Problems in Patients With Enteral Nutrition in Pediatric Intensive Care: A Randomized Controlled Study","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-12-31","last_update":"2021-04-13","description":"Many system functions differ in children dependent on mechanical ventilation support and may present with various complications. In the gastrointestinal system, gastric and duodenum-related decreased motility disorders are a very common problem in critically ill patients hospitalized in the intensive care unit, which increases mortality and morbidity. The prevalence of gastric dysmotility in pediatric intensive care is estimated to be 50%. Gastric problems such as vomiting, increase in the amount of gastric residue, decrease in bowel movements, abdominal distension, diarrhea/ constipation, etc. are observed as a result of the dysfunction of the gastrointestinal system. In addition to these problems; there are problems associated with the ventilator such as pneumonia, infection, bacterial growth, and stopping enteral feeding. Malnutrition as a result of stopping feeding prolongs the hospitalization of intensive care patients and affects mortality. Intensive care nurses play a key role in providing nutritional support to patients who receive mechanical ventilation support and whose level of consciousness is reduced. Intensive care nurses have many responsibilities such as timely initiation of nutrition, application of correct nutrition, correct placement of feeding tubes, and prevention of problems that may arise as a result of nutrition. Abdominal massage practice is a therapeutic, independent, and evidence-based nursing intervention. It has been used for many years to increase the motility of the gastrointestinal system and to treat constipation. Inexpensive and easy to apply abdominal massage compared to other methods; It increases intestinal motility, accelerates the mechanical advancement of nutrients in the digestive system, improves the blood flow of the region, and is effective in reducing intra-abdominal pressure. It has been reported in the literature that abdominal massage applied to preterm babies increases nutritional tolerance. Studies on adults have also reported that gastric residue is reduced, less vomiting is experienced, and abdominal distension is less common. However, there is no study examining the effects of abdominal massage in reducing gastrointestinal problems in children hospitalized in pediatric intensive care units and receiving ventilator support. Therefore, the aim of this study is to examine the effect of abdominal massage on gastric problems in children who are fed enterally in the pediatric intensive care unit.","other_id":"202173","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"Triple","intervention_model_description":"The study will be conducted in a randomized controlled experimental and single-blind study design.","sampling_method":"","gender":"All","minimum_age":0.08333,"maximum_age":2,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  The child's family volunteering to the research\r\n\r\n          -  The ages of the children participating in the study are between 30 days and 24 months.\r\n\r\n          -  At least 48 hours of mechanical ventilation support\r\n\r\n          -  Beginning of enteral feeding and at least 24 hours have passed since\r\n\r\n          -  Feeding with a nasogastric tube\r\n\r\n          -  Very low, low or moderate mortality score according to the PRISM III score\r\n\r\n          -  Not having had abdominal surgery\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  High or very high mortality score compared to the PRISM III score\r\n\r\n          -  Anatomically, the absence of gastrointestinal system integrity Having a gastrostomy or\r\n             stoma Having a tracheostomy\r\n\r\n          -  notrope receiving treatment\r\n\r\n          -  Hemodynamics is not stable\r\n\r\n          -  Intracranial bleeding, increased intracranial pressure, cranial tumor, etc. having a\r\n             severe neurological problem, such as\r\n      ","sponsor":"Istanbul University-Cerrahpasa","sponsor_type":"Other","conditions":"Intensive Care Units, Pediatric|Massage|Nutrition Disorders|Nurse's Role","interventions":[{"intervention_type":"Other","name":"Other: Abdominal massage","description":"The effect on gastric problems by applying abdominal massage to eligible participants in the study will be examined."}],"outcomes":[{"outcome_type":"primary","measure":"Variation of intra abdominal pressure measurement compared to abdominal massage","time_frame":"Three days","description":"Data will be collected in line with the intra-abdominal pressure measurement protocol created by the researcher. Measurements will be made with the help of a bladder catheter that is present in the patient. The measurement will be repeated before and after the massage."},{"outcome_type":"primary","measure":"Variation of gastric residue measurement compared to abdominal massage","time_frame":"Three days","description":"The gastric residue will be checked by the nurses with a feeding syringe and recorded on the investigation form. Before each feeding, gastric residue will be checked. Before and after the massage results will be compared."},{"outcome_type":"primary","measure":"Measurement of abdominal circumference in centimeters","time_frame":"Three days","description":"The abdominal circumference of the patient is measured with the help of a tape measure."},{"outcome_type":"primary","measure":"Bowel sounds in minutes / numbers","time_frame":"Three days","description":"Bowel sounds are listened to with a stethoscope on four quadrants for one minute."},{"outcome_type":"primary","measure":"Presence of abdominal distension","time_frame":"Three days","description":"The abdomen of the patient is examined manually and evaluated in terms of distension."},{"outcome_type":"primary","measure":"Presence of defect in terms of days / frequency","time_frame":"Three days","description":"It is recorded how many times the patient defecated during the day."},{"outcome_type":"primary","measure":"Presence of vomiting in terms of days / frequency","time_frame":"Three days","description":"How many times the patient vomited during the day is recorded."}]}
{"nct_id":"NCT04472845","start_date":"2021-03-30","phase":"N/A","enrollment":1018,"brief_title":"HYPofractionated Adjuvant RadioTherapy in 1 Versus 2 Weeks in High-risk Patients With Breast Cancer (HYPART).","official_title":"HYPofractionated Adjuvant RadioTherapy in 1 Versus 2 Weeks in High-risk Patients With Breast Cancer (HYPART): A Non-inferiority, Open-label, Phase III Randomized Trial.","primary_completion_date":"2023-08-20","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2028-08-20","last_update":"2021-06-25","description":"We at PGIMER have been practicing hypofractionated radiotherapy in breast cancer patients for the last 4 decades. Our standard doses have been 35Gy/15#/3wks to the chest wall after mastectomy and 40Gy/16#/3wks after breast conserving surgery (BCS).It is also a routine practice in the UK and in a few centers in Canada. Hypofractionation reduces treatment time to half while maintaining cosmesis and gives control rates equal to conventional fractionation. As breast cancer is a leading cancer in females and radiation therapy is an important part of its local management, hypofractionation helps radiation centers worldwide to meet the growing need for radiation treatment in breast cancer, particularly in developing countries where resources are limited. It also reduces the financial burden on the patient and family. In this study we want to evaluate the impact of reducing the treatment duration from 3 weeks to 1 week. Eligible patients with breast cancer after mastectomy or BCS will be treated with a radiotherapy dose of 26Gy in 5 fractions over 1 week in the study arm and 40Gy in 15 fractions over 2 weeks in the control arm. The primary endpoint of this noninferiority study will be locoregional tumour control. Secondary endpoints will be early and late radiation toxicities, quality of life, contralateral primary tumours, regional and distant metastases, survival and second cancers. A total of 1018 patients will be randomised (1:1) to receive 1 week or 2 weeks of radiotherapy. An event-driven analysis will be performed after at least 94 patients have documented locoregional recurrences.","other_id":"HYPART","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age 18 years\r\n\r\n          2. Female or male\r\n\r\n          3. Invasive carcinoma of the breast\r\n\r\n          4. Breast conserving surgery(BCS) with axillary clearance or total mastectomy with\r\n             axillary clearance(TMAC); (reconstruction allowed but not with implant; tissue\r\n             expanders with distant metal ports are allowed)\r\n\r\n          5. Concurrent trastuzumab and hormone therapy is allowed\r\n\r\n          6. Axillary staging and/or dissection\r\n\r\n          7. Complete microscopic excision of primary tumour\r\n\r\n          8. pT3-4pN2-3 M0 disease\r\n\r\n          9. Clinical stage III disease or pathological node positive if they have received\r\n             neo-adjuvant chemotherapy.\r\n\r\n         10. Written informed consent\r\n\r\n         11. Able to comply with follow-up\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Supraclavicular node or internal mammary node or distant metastasis\r\n\r\n          2. Past history of malignancy except (i) basal cell skin cancer and CIN cervix uteri\r\n             or(ii) non-breast malignancy allowed if treated with curative intent and at least 5\r\n             years disease free\r\n\r\n          3. Contralateral breast cancer, including DCIS, irrespective of date of diagnosis\r\n\r\n          4. Breast reconstruction using implants\r\n\r\n          5. Pregnancy\r\n\r\n          6. Concurrent cytotoxic chemotherapy(sequential neoadjuvant or adjuvant cytotoxic therapy\r\n             allowed)\r\n      ","sponsor":"Postgraduate Institute of Medical Education and Research","sponsor_type":"Other","conditions":"Breast Cancer|Hypofractionation|Radiotherapy Side Effect","interventions":[{"intervention_type":"Radiation","name":"Radiation: 1 week RT","description":"RT will be delivered over 1 week"},{"intervention_type":"Radiation","name":"Radiation: 2 week RT","description":"RT will be delivered over 2 week"}],"outcomes":[{"outcome_type":"primary","measure":"Loco-regional recurrence, Change is being assessed","time_frame":"5, 10 and 15 years","description":"disease recurrence in the ipsilateral chest wall or regional lymph nodes from the time of randomization until the end of follow-up."},{"outcome_type":"secondary","measure":"Disease-free survival, Change is being assessed","time_frame":"5, 10 and 15 years","description":"locoregional recurrence, distant metastasis, or death from any cause from the time of randomisation until the end of follow-up."},{"outcome_type":"secondary","measure":"Overall survival, Change is being assessed","time_frame":"5, 10 and 15 years","description":"death from any cause from the time of randomisation until the end of follow-up"},{"outcome_type":"secondary","measure":"Acute radiation toxicity","time_frame":"3 months","description":"Any loco-regional toxicity assessed and scaled according to the RTOG grading system."},{"outcome_type":"secondary","measure":"Late adverse events, Change is being assessed","time_frame":"5, 10 and 15 years","description":"Any adverse event occurring after 6 months of RT"},{"outcome_type":"secondary","measure":"Quality of life(QoL), Change is being assessed","time_frame":"Baseline, 3 and 5 years","description":"QoL will be assessed with EORTC QLQ -30. The QLQ-C30 is composed of both multi-item scales and single-item measures, as well as five functional scales, three symptom scales, a global health status/QoL scale, and six single items. The scores must be averaged and linearly transformed to obtain a range of scores from 0 to 100, with a higher score representing a greater response level."}]}
{"nct_id":"NCT04808180","start_date":"2021-03-25","phase":"N/A","enrollment":40,"brief_title":"Clinical Efficacy of Biomimetic Hydroxyapatite in the Treatment of Molar Incisor Hypomineralization.","official_title":"Effects of Biomimetic Hydroxyapatite in the Treatment of Molar Incisor Hypomineralization: a Randomized Clinical Trial.","primary_completion_date":"2021-11-27","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2021-12-27","last_update":"2021-06-02","description":"The aim of the following study is to evaluate che clinical efficacy of a toothpaste with biomimetic hydroxyapatite for the management of Molar-Incisor Hypomineralization. Patients who agree to participate to the study will use Biorepair toothpaste for the first 7 days of the month for 3 and 6 months depending on the degree of demineralizations. Intact Toot Application will be used for the evaluation of the demineralizations during the study and the following indices will be measured: BEWE, Bleeding Index, Gingival index, Plaque index and the dental sensitivity test.","other_id":"2021-MIH","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  presence of at least 2 enamel demineralizations of permanent molars and incisors\r\n             (Molar-Incisor Hypomineralization - MIH) in two different quadrants\r\n\r\n          -  good general health (absence of systemic diseases)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  patients undergoing orthodontic therapy\r\n\r\n          -  patients taking drugs\r\n      ","sponsor":"University of Pavia","sponsor_type":"Other","conditions":"Molar Incisor Hypomineralization","interventions":[{"intervention_type":"Other","name":"Other: Biorepair Shock Treatment","description":"Patients from this group will use Biorepair Toothpaste for the first 7 days of the month for 3 months (mild demineralizations) and for 6 months (moderate demineralizations)."}],"outcomes":[{"outcome_type":"primary","measure":"Change of the Bleeding Index","time_frame":"Study begin, 1,2,3 and 6 months","description":"Scoring criteria:\r\n0: absence of bleeding after 30 seconds\r\n1: bleeding observed after 30 seconds\r\n2: immediate bleeding"},{"outcome_type":"primary","measure":"Change of the GI - Gingival Index (Loe and Silness, 1963)","time_frame":"Study begin, 1,2,3, and 6 months","description":"Scoring criteria:\r\n0 = normal gingiva.\r\n= mild inflammation, edema and swelling; no bleeding.\r\n= moderate inflammation with edema, swelling and bleeding on probing.\r\n= severe inflammation with marked edema, redness tissues, ulceration and spontaneous bleeding."},{"outcome_type":"primary","measure":"Change of PCR - Plaque Control Record (O'Leary, 1972)","time_frame":"Study begin, 1,2,3, and 6 months","description":"4 surfaces scored (mesial, distal, vestibular, labial/palatal) per tooth by means of plaque relevator.\r\nThe Index is calculated multiplying the total number of surfaces with plaque per 100."},{"outcome_type":"primary","measure":"Change of the dental sensitivity - Dental sensitivity test","time_frame":"Study begin, 1,2,3, and 6 months","description":"A compressed air flow and then a cold stimulus with water at 0°C. The intensity of discomfort is assessed thanks to a VAS scale."},{"outcome_type":"primary","measure":"Change of the BEWE Index - Basic Erosive Wear Examination (Barlet et al., 2008)","time_frame":"Study begin, 1,2,3 and 6 months","description":"Scoring criteria:\r\n0: no erosive tooth wear;\r\n1: initial loss of surface texture;\r\n2: distinct defect, hard tissue loss < 50% of the surface area;\r\n3: hard tissue loss ≥ 50% of the surface area."}]}
{"nct_id":"NCT04748822","start_date":"2021-03-25","phase":"N/A","enrollment":200,"brief_title":"Quality of Life in Patients With Alcohol Use Disorder","official_title":"Factors Associated With Quality of Life in Patients With Alcohol Use Disorder","primary_completion_date":"2023-02-28","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-09-30","last_update":"2021-08-09","description":"The primary purpose of this study is to investigate the factors associated with quality of life of patients with alcohol use disorder (AUD) undergoing a detoxification program (cross-sectional analysis). The secondary purpose is (1) to identify the factors associated with change in quality of life between baseline and 6-month follow-up, and (2) to identify the factors associated with alcohol relapse at 6 months (longitudinal analyses).","other_id":"2020-A02853-36","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","intervention_model_description":"Prospective cohort study","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  DSM-5 AUD criteria\r\n\r\n          -  At least 18 years of age\r\n\r\n          -  Within the 10th and 21st day of a detoxification program.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Communication difficulties (insufficient level of French, major hearing or visual\r\n             impairment, major cognitive deficit)\r\n\r\n          -  Under guardianship\r\n\r\n          -  Under justice control\r\n\r\n          -  Cannot be reached by phone\r\n      ","sponsor":"Hpital le Vinatier","sponsor_type":"Other","conditions":"Alcohol Use Disorder","interventions":[{"intervention_type":"Other","name":"Other: questionnaires","description":"The Alcohol Quality of Life Scale (AQoLS) will be completed at baseline and at 6-month follow-up. Alcohol status (relapse/abstinence) will be assessed at 6 months."}],"outcomes":[{"outcome_type":"primary","measure":"Quality of life in patients with AUD.","time_frame":"Within the 10th and 21st day of the detoxification program (baseline assessment).","description":"Alcohol Quality of Life Scale."},{"outcome_type":"secondary","measure":"Quality of life in patients with AUD 6 months after the detoxification program.","time_frame":"6 months after the baseline assessment.","description":"Alcohol Quality of Life Scale."},{"outcome_type":"secondary","measure":"Alcohol status","time_frame":"6 months after the baseline assessment.","description":"Alcohol (relapse/abstinence)"}]}
{"nct_id":"NCT04793295","start_date":"2021-03-23","phase":"Phase 1","enrollment":111,"brief_title":"Study to Investigate Drug-Drug Interaction Between MT-7117 and Test Drugs in Healthy Subjects","official_title":"A Phase I, Open-Label, Four-Part, Single-Sequence Study to Investigate Drug-Drug Interaction Between MT-7117 and Test Drugs in Healthy Subjects","primary_completion_date":"2021-10-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-10-31","last_update":"2021-07-07","description":"Study is to investigate drug levels in the blood after taking single or multiple doses of the study drug, MT-7117, in healthy adults when taken together with another drug. This study will also look at the safety and the body's ability to tolerate MT-7117","other_id":"MT-7117-Z-102","allocation":"Non-Randomized","intervention_model":"Sequential Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","intervention_model_description":"Open Label","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria: Subjects will be eligible for inclusion in the study if they meet all\r\n        of the following criteria:\r\n\r\n          1. Able and willing to provide written informed consent to participate in this study\r\n             after reading the participant information sheet and Informed Consent Form (ICF) and\r\n             having the opportunity to discuss the study with the Investigator or designee.\r\n\r\n          2. White (a person having origins in any of the original peoples of Europe, the Middle\r\n             East or North Africa) male or female subjects, 18-55 years of age, inclusive, at the\r\n             time of signing the ICF.\r\n\r\n          3. Subjects must weigh at least 50 kg (110 pounds) and have a body mass index 18-30\r\n             kg/m2, inclusive, at Screening and on Day -1.\r\n\r\n          4. Female subjects must not be lactating, and women of childbearing potential must have a\r\n             negative serum pregnancy test at Screening and a negative urine pregnancy test within\r\n             24 hours prior to receiving the first dose of IMP or IMP Test Products.\r\n\r\n          5. Female subjects of childbearing potential and male subjects with a partner of\r\n             childbearing potential must agree to use 2 effective methods of contraception (in\r\n             female subjects, one method must be highly effective). Full details of contraception\r\n             in Section 4.6.5.\r\n\r\n          6. In the Investigator's opinion, the subject must be able to understand the nature of\r\n             the study and any risks involved in participation and be willing to cooperate and\r\n             comply with the protocol restrictions and requirements.\r\n\r\n        Exclusion Criteria: Any subject meeting any of the following criteria will not qualify for\r\n        enrolment in the study:\r\n\r\n          1. Current, or history of, clinically significant (in the opinion of the Investigator)\r\n             neurological conditions, endocrine, thyroid, hepatic, respiratory, gastrointestinal,\r\n             renal, or cardiovascular disease, or history (within the last 2 years) of any\r\n             clinically significant psychiatric/psychotic illness disorder (including anxiety,\r\n             depression, and reactive depression).\r\n\r\n          2. Clinically relevant abnormal medical history, physical findings, or laboratory values\r\n             at Screening or Day-1 that could interfere with the objectives of the study or the\r\n             safety of the subjects, in the opinion of the Investigator.\r\n\r\n          3. A history of gastrointestinal surgery known to affect the absorption, metabolism, or\r\n             excretion of the IMP or IMP Test Products such as bariatric surgery or removal of part\r\n             of the bowel. A history of appendicectomy and hernia repair/herniorrhaphy/hernioplasty\r\n             is permitted for inclusion in the study.\r\n\r\n          4. Family history of long or short QT syndrome, hypokalemia, syncope, or Torsades de\r\n             Pointes.\r\n\r\n          5. Clinically significant 12-lead electrocardiogram (ECG) abnormalities, including\r\n             subjects with corrected QC interval (QTc) using Fridericia's formula >450 ms (male)\r\n             and >470 ms (female), at Screening or Day -1. A repeat assessment is allowed at each\r\n             visit. If the repeat measurement is in range, the subject may be included.\r\n\r\n          6. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 1.5 the upper limit\r\n             of normal (ULN) reference range, or bilirubin  1.5 ULN at screening or Day-1. A\r\n             repeat assessment is allowed at each visit. If the repeat measurement is in range, the\r\n             subject may be included.\r\n\r\n          7. Systolic blood pressure outside the range of 90-145 mmHg, diastolic blood pressure\r\n             outside the range of 50-95 mmHg, or pulse rate outside the range of 50-100 bpm, taken\r\n             in the supine position at Screening or Day -1. A repeat assessment is allowed at each\r\n             visit. If the repeat measurement is in range, the subject may be included.\r\n\r\n          8. Receipt of any prescribed of nonprescribed systemic or topical medication within 30\r\n             days (or, if relevant, 5 half-lives, whichever is longer) prior to the first dose of\r\n             study drugs unless, in the opinion of the Investigator and Sponsor, the medication\r\n             will not interfere with the study procedures or compromise subject safety.\r\n\r\n               1. Occasional use of paracetamol (acetaminophen) for mild analgesia is permitted.\r\n\r\n               2. Vitamins and herbal supplements are not permitted 14 days prior to dosing\r\n\r\n          9. Presence or history of severe adverse reaction or allergy to food or any drug or\r\n             excipient or other allergy that is of clinical significance to the study drugs.\r\n\r\n         10. Previous receipt of MT-7117.\r\n\r\n         11. First-degree relative with a history of familial melanoma.\r\n\r\n         12. Previous use of afamelanotide or melanotan.\r\n\r\n         13. Female subjects planning to donate eggs (during the study and for 3 months after the\r\n             last visit).\r\n\r\n         14. Positive test for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C\r\n             antibody, or human immunodeficiency virus (HIV) 1 or HIV 2 antibodies at Screening.\r\n\r\n         15. Presence or history of drug abuse (as defined by Diagnostic and Statistical Manual of\r\n             Mental Disorders criteria), or a positive urine test for drugs of abuse at Screening\r\n             or Day -1.\r\n\r\n         16. Presence or history (in the last 2 years) of alcohol abuse or excessive alcohol\r\n             consumption, defined as subjects who regularly, or on average, drink more than 21\r\n             units (168 g) for males or 14 units (112 g) for females, of alcohol per week (1 unit\r\n             is equivalent to 8 g of alcohol).\r\n\r\n         17. Use of tobacco or nicotine-containing products (snuff, chewing tobacco, cigarettes,\r\n             cigars, pipes, e-cigarettes, or nicotine replacement products) within 3 months prior\r\n             to dosing, or a positive urine cotinine test at Screening or Day -1.\r\n\r\n         18. Consumption of food or drink containing oranges, grapefruit, liquorice, or cranberry\r\n             within the 7 days prior to the first dose of study drug.\r\n\r\n         19. Subjects who are not willing to abstain from consumption of caffeine and\r\n             methylxanthine (e.g., coffee, tea, cola, energy drinks, or chocolates) in the 48 hours\r\n             before Day -1 until completion of the post-treatment assessments and in the 48 hours\r\n             before the Follow-up/End of Study Visit.\r\n\r\n         20. Donation of 1 or more units of blood (450 mL) in the 3 months prior to Screening,\r\n             plasma in the 7 days prior to Screening, platelets in the 6 weeks prior to Screening,\r\n             or the intention to donate blood within 3 months after the last scheduled visit.\r\n\r\n         21. Heavy physical training, labor, or excessive exercise (e.g., long-distance running,\r\n             weightlifting, or any physical activity to which the subject is not accustomed) from 3\r\n             days before the administration of study drugs.\r\n\r\n         22. Participation in more than 3 clinical studies* involving administration of an IMP in\r\n             the previous year, or any study* involving administration of an IMP within 12 weeks\r\n             (or, if relevant, 5 half-lives, whichever is longer) prior to the first dose of study\r\n             drug.\r\n\r\n             *Disregarding any study Follow-up Periods.\r\n\r\n         23. Subjects with the presence of a skin lesion suspicious for dysplastic nevus or a\r\n             history of histologically proven dysplastic nevus.\r\n\r\n         24. Subjects who have any active malignancy (including melanoma) or history of significant\r\n             malignancy (including melanoma).\r\n\r\n         25. Subjects who have had Coronavirus Disease 2019 (COVID-19) in the 3 months prior to\r\n             Screening; or suspected active COVID-19 infection, a positive COVID-19 test, contact\r\n             with an individual with known COVID-19, or travel to an area with a high risk of\r\n             COVID-19 infection within 14 days of Screening.\r\n\r\n         26. Subjects that test positive for COVID-19 at Day - 1.\r\n\r\n         27. Subjects who have received a COVID-19 vaccination within 14 days of Day 1. COVID-19\r\n             vaccination is not permitted during the study. Subjects may not take part in the study\r\n             if they have started but not completed a COVID-19 vaccination course at the time of\r\n             Screening or Day -1.\r\n\r\n         28. Subjects who have a history of major surgery within 3 months of Day 1.\r\n      ","sponsor":"Mitsubishi Tanabe Pharma Development America, Inc.","sponsor_type":"Industry","conditions":"Healthy Subjects","interventions":[{"intervention_type":"Drug","name":"Drug: MT-7117","description":"MT-7117"}],"outcomes":[{"outcome_type":"primary","measure":"Maximum observed plasma concentration (Cmax)","time_frame":"Part 1 Day 1 to Day 19, Part 2 Day 1 to Day 15, Part 3 Day 1 to Day 17, Part 4 Day 1 to Day 13","description":"PK parameters of IMP Test Products in the absence and presence of MT-7117 (Parts 1, 2, and 3) and MT-7117 in the absence and presence of test drug 7 (Part 4)"},{"outcome_type":"primary","measure":"Area under the plasma concentration-time curve (AUC) from time zero to infinity (AUC0-∞)","time_frame":"Part 1 Day 1 to Day 19, Part 2 Day 1 to Day 15, Part 3 Day 1 to Day 17, Part 4 Day 1 to Day 13","description":"PK parameters of IMP Test Products in the absence and presence of MT-7117 (Parts 1, 2, and 3) and MT-7117 in the absence and presence of test drug 7 (Part 4)"},{"outcome_type":"primary","measure":"AUC from time zero to the last measurable concentration (AUC0-last)","time_frame":"Part 1 Day 1 to Day 19, Part 2 Day 1 to Day 15, Part 3 Day 1 to Day 17, Part 4 Day 1 to Day 13","description":"PK parameters of IMP Test Products in the absence and presence of MT-7117 (Parts 1, 2, and 3) and MT-7117 in the absence and presence of test drug 7 (Part 4)"},{"outcome_type":"secondary","measure":"Time to reach maximum plasma concentration (tmax)","time_frame":"Part 1 Day 1 to Day 19, Part 2 Day 1 to Day 15, Part 3 Day 1 to Day 17, Part 4 Day 1 to Day 13","description":"PK parameters of IMP Test Products in the absence and presence of MT-7117 (Parts 1, 2, and 3) and MT-7117 in the absence and presence of test drug 7 (Part 4)"},{"outcome_type":"secondary","measure":"t1/2","time_frame":"Part 1 Day 1 to Day 19, Part 2 Day 1 to Day 15, Part 3 Day 1 to Day 17, Part 4 Day 1 to Day 13","description":"PK parameters of IMP Test Products in the absence and presence of MT-7117 (Parts 1, 2, and 3) and MT-7117 in the absence and presence of test drug 7 (Part 4)"},{"outcome_type":"secondary","measure":"Apparent oral clearance","time_frame":"Part 1 Day 1 to Day 19, Part 2 Day 1 to Day 15, Part 3 Day 1 to Day 17, Part 4 Day 1 to Day 13","description":"PK parameters of IMP Test Products in the absence and presence of MT-7117 (Parts 1, 2, and 3) and MT-7117 in the absence and presence of test drug 7 (Part 4)"},{"outcome_type":"secondary","measure":"Apparent volume of distribution during the terminal phase after oral administration","time_frame":"Part 1 Day 1 to Day 19, Part 2 Day 1 to Day 15, Part 3 Day 1 to Day 17, Part 4 Day 1 to Day 13","description":"PK parameters of IMP Test Products in the absence and presence of MT-7117 (Parts 1, 2, and 3) and MT-7117 in the absence and presence of test drug 7 (Part 4)"},{"outcome_type":"secondary","measure":"Cmax","time_frame":"Part 1 Day 1 to Day 19, Part 2 Day 1 to Day 15, Part 3 Day 1 to Day 17, Part 4 Day 1 to Day 13","description":"PK parameters of IMP Test Products metabolites in the absence and presence of MT-7117 (Parts 1, 2, and 3)"},{"outcome_type":"secondary","measure":"tmax","time_frame":"Part 1 Day 1 to Day 19, Part 2 Day 1 to Day 15, Part 3 Day 1 to Day 17, Part 4 Day 1 to Day 13","description":"PK parameters of IMP Test Products metabolites in the absence and presence of MT-7117 (Parts 1, 2, and 3)"},{"outcome_type":"secondary","measure":"t1/2","time_frame":"Part 1 Day 1 to Day 19, Part 2 Day 1 to Day 15, Part 3 Day 1 to Day 17, Part 4 Day 1 to Day 13","description":"PK parameters of IMP Test Products metabolites in the absence and presence of MT-7117 (Parts 1, 2, and 3)"},{"outcome_type":"secondary","measure":"AUC0-last","time_frame":"Part 1 Day 1 to Day 19, Part 2 Day 1 to Day 15, Part 3 Day 1 to Day 17, Part 4 Day 1 to Day 13","description":"PK parameters of IMP Test Products metabolites in the absence and presence of MT-7117 (Parts 1, 2, and 3)"},{"outcome_type":"secondary","measure":"AUC0-∞","time_frame":"Part 1 Day 1 to Day 19, Part 2 Day 1 to Day 15, Part 3 Day 1 to Day 17, Part 4 Day 1 to Day 13","description":"PK parameters of IMP Test Products metabolites in the absence and presence of MT-7117 (Parts 1, 2, and 3)"},{"outcome_type":"secondary","measure":"MT-7117 concentrations in plasma","time_frame":"Part 1 Day 1 to Day 19, Part 2 Day 1 to Day 15, Part 3 Day 1 to Day 17, Part 4 Day 1 to Day 13"},{"outcome_type":"secondary","measure":"Safety and tolerability as measured by incidence of adverse events","time_frame":"Part 1 Day -1 to Day 25, Part 2 Day -1 to Day 21, Part 3 Day -1 to Day 23, Part 4 Day -1 to Day 19"}]}
{"nct_id":"NCT04809558","start_date":"2021-03-22","phase":"N/A","enrollment":100,"brief_title":"Optimal Method for Tongue Strengthening","official_title":"Determining an Optimal Delivery Method for Tongue Strengthening During Swallowing Rehabilitation: Building a Framework for Clinical Practice","primary_completion_date":"2022-03-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2022-05-01","last_update":"2021-03-22","description":"The research team will conduct a multi-site, randomized controlled trial examining the effectiveness of exercise intensity progression compared to standard practice (no progression) in the context of swallowing rehabilitation. The study will also determine the impact of using biofeedback during resistance training on tongue strength. The study is a first step in determining an optimal delivery of tongue strengthening exercise in typically aging older persons, with the plan to develop a framework for guiding clinical practice of tongue strengthening in various dysphagic populations. Participants will be randomized into one of four treatment groups and complete 8 weeks of tongue resistance training.","other_id":"EXPD-HP-20-F-5","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Are age 55 or older\r\n\r\n          -  < 3 score on Eating Assessment Tool-10 (screening tool for swallowing difficulty)\r\n\r\n          -  > 24 score on Mini Mental State Examination (screening tool for cognitive impairment)\r\n\r\n          -  Have a normal oral structure as assessed with an oral mechanism screener\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  A history of seizures (contraindication for Tongueometer use)\r\n\r\n          -  Past or present pain disorders involving the jaw or mandible (e.g., TMJ disorder,\r\n             myofascial pain disorder) (contraindication for Tongueometer use)\r\n\r\n          -  A history of oral surgery (routine dental surgery acceptable)\r\n\r\n          -  A history of neurogenic disorder (e.g., Parkinson's disease)\r\n\r\n          -  A history of swallowing difficulty\r\n\r\n          -  Not being able to complete an 8-week study protocol\r\n      ","sponsor":"Samford University","sponsor_type":"Other","conditions":"Focus of Study is Tongue Strength","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Tongue resistance exercise","description":"Participant will complete tongue resistance exercises."}],"outcomes":[{"outcome_type":"secondary","measure":"Exercise adherence tracking","time_frame":"Collected at Weeks, 2, 4, 6, 8; and 1-month post if participant was randomized to a maintenance program","description":"Adherence tracking will be completed by asking participants to keep record form logs of sessions completed"},{"outcome_type":"primary","measure":"Change in maximum isometric tongue pressure (MIP)","time_frame":"Multiple baselines (2), every 2 weeks following for 8 weeks, 1-month post if person randomized to a maintenance program","description":"MIP in kilopascals (kPa)"},{"outcome_type":"primary","measure":"Change in regular effort saliva swallow pressure (RESS)","time_frame":"Multiple baselines (2), every 2 weeks following for 8 weeks, 1-month post if person randomized to a maintenance program","description":"RESS is kilopascals (kPa)"},{"outcome_type":"primary","measure":"Change in effortful swallow pressure (ESP)","time_frame":"Multiple baselines (2), every 2 weeks following for 8 weeks, 1-month post if person randomized to a maintenance program","description":"ESP in kilopascals (kPa)"},{"outcome_type":"secondary","measure":"Change in participant-perceived motivation for assigned exercise regimen","time_frame":"Multiple baselines (2), every 2 weeks following for 8 weeks, 1-month post if person randomized to a maintenance program","description":"Standardized 0 mm (lowest level of perceived motivation) to 100 mm (highest level of perceived motivation) visual-analog scale participant perception of internal motivation."},{"outcome_type":"secondary","measure":"Change in participant-perceived confidence for assigned exercise regimen","time_frame":"Multiple baselines (2), every 2 weeks following for 8 weeks, 1-month post if person randomized to a maintenance program","description":"Standardized 0 mm (lowest level of perceived confidence) to 100 mm (highest level of perceived confidence) visual-analog scale participant perception of internal confidence."}]}
{"nct_id":"NCT04574778","start_date":"2021-03-18","phase":"Phase 3","enrollment":82,"brief_title":"Randomized Trial of Intraoperative IV Versus Preoperative Oral Acetaminophen During Ambulatory Lumbar Discectomy","official_title":"Randomized Trial of IV Versus Oral Acetaminophen for Ambulatory Lumbar Discectomy or Single-level Decompression","primary_completion_date":"2021-10-31","study_type":"Interventional","rec_status":"Enrolling by invitation","completion_date":"2021-10-31","last_update":"2021-03-23","description":"Effective non-opioid analgesics are of particular interest in ambulatory surgery, as providers may be able to reduce pain while avoiding perioperative opioids that can delay same day discharge. The value of maintaining an efficient flow of patients from the perioperative area to discharge is an important metric for same day surgery centers, and an improvement in efficiency with IV acetaminophen could potentially offset the increased cost of the medication while providing a more pleasant surgical experience for patients. The goal of this study is to compare the efficacy of intraoperative IV administration vs. preoperative oral administration of acetaminophen on postoperative opioid utilization, patient-reported pain scores, opioid-related adverse effects, and time to recovery and discharge from the post-anesthesia care unit (PACU) after ambulatory lumbar discectomy.","other_id":"GSCHR19D.660","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age greater than 18 years-old\r\n\r\n          -  Weight greater than 50 kg body weight\r\n\r\n          -  ASA physical status I-III\r\n\r\n          -  English-speaking\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Weight less than 50 kg\r\n\r\n          -  Pregnancy or breast feeding\r\n\r\n          -  Prior lumbar surgery\r\n\r\n          -  Contraindications to the administration of acetaminophen (e.g. allergy, liver failure,\r\n             etc)\r\n\r\n          -  Chronic pain conditions unrelated to back pain\r\n\r\n          -  Opioid tolerance ( defined as taking greater than oxycodone 20 mg daily for a week\r\n             during the past month).\r\n      ","sponsor":"Rothman Institute Orthopaedics","sponsor_type":"Other","conditions":"Pain, Postoperative|Spine Surgery","interventions":[{"intervention_type":"Drug","name":"Drug: Acetaminophen","description":"1000 mg of oral acetaminophen preoperatively + IV placebo infusion intraoperatively 30 minutes prior to closure"}],"outcomes":[{"outcome_type":"primary","measure":"Postoperative opioid usage","time_frame":"1 day","description":"Postoperative opioid usage over the first 24 hours will be reported in IV morphine equivalents"},{"outcome_type":"secondary","measure":"Quality of recovery","time_frame":"1 day","description":"assessed using the Quality of Recovery 15 scale, with a range of 0-150 (0 is the worst score and 150 is the best possible recovery)"},{"outcome_type":"secondary","measure":"Number of patients who report nausea or vomiting","time_frame":"1 day","description":"this will be a count of the number of patients who report nausea or vomiting in recovery room"},{"outcome_type":"secondary","measure":"Mean pain score","time_frame":"1 day","description":"(0-10 numerical rating scale where 0=no pain and 10=worst pain imaginable) - this will be the mean pain rating upon entering pacu and at least 1 other time point in each study group"}]}
{"nct_id":"NCT04687358","start_date":"2021-03-16","enrollment":500,"brief_title":"REgiStry Of the NAtural History of recurreNt periCarditis in pEdiatric and Adult Patients","official_title":"Registry of the Natural History of Recurrent Pericarditis in Pediatric and Adult Patients","primary_completion_date":"2026-02-28","study_type":"Observational [Patient Registry]","rec_status":"Recruiting","completion_date":"2026-02-28","last_update":"2021-08-06","description":"The registry will focus on furthering the understanding of the natural history of recurrent pericarditis (RP), as well as document RP-related clinical, health-related quality of life (HRQoL), and economic burden and will assist the medical community to refine or develop data-driven recommendations for clinical management of RP patients to optimize clinical outcomes. It also aims to generate data in support of the impact of rilonacept on clinical outcomes in a real-world population.","other_id":"KPL-914-Reg-001","observational_model":"Cohort","time_perspective":"Other","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":7,"population":"Patients with active or inactive recurrent pericarditis who have participated in the\r\n        RHAPSODY (KPL-914-C002) Phase 3 clinical study of rilonacept and patients from sites who\r\n        have expressed an interest in the registry will be included. In addition, RESONANCE will\r\n        also include decentralized sites for remote patients who wish to participate in the\r\n        registry but are not near a registry site.","criteria":"\n        ACTIVE RP PATIENTS\r\n\r\n        Select Inclusion Criteria:\r\n\r\n          -  Physician-confirmed (or confirmation in medical records) diagnosis of RP defined as an\r\n             initial, acute, episode and at least one pericarditis recurrence after the initial\r\n             acute episode\r\n\r\n          -  Experienced at least one pericarditis episode in the 3 years prior to inclusion\r\n\r\n          -  Under the care of a physician for the treatment and management of RP\r\n\r\n          -  Currently prescribed medication for RP\r\n\r\n        Select Exclusion Criteria:\r\n\r\n          -  Diagnosis of pericarditis secondary to tuberculosis (TB), cancer if not in full\r\n             remission, post thoracic blunt trauma (e.g., motor-vehicle accidents), myocarditis,\r\n             systemic autoimmune diseases, except SJIA and adult Still's disease, HIV\r\n\r\n          -  Appears to have an impairment (e.g., cognitive, hearing, visual) or insufficient\r\n             English or Spanish proficiency that could interfere with ability to complete\r\n             patient-completed assessments\r\n\r\n          -  Currently enrolled in a therapeutic investigational drug or device study\r\n\r\n        INACTIVE RP PATIENTS\r\n\r\n        Select Inclusion Criteria:\r\n\r\n          -  Physician-confirmed (or confirmation in medical records) diagnosis of RP defined as an\r\n             initial, acute, episode and at least one pericarditis recurrence after the initial,\r\n             acute episode\r\n\r\n          -  Patient had a last episode occurring at least 3 years and up to 5 years before\r\n             registry inclusion\r\n\r\n          -  Resolution of RP symptoms confirmed with no further RP treatment for 3 years prior to\r\n             registry enrollment\r\n\r\n        Select Exclusion Criteria:\r\n\r\n          -  Experienced a pericarditis episode within 3 years from enrolling in the registry\r\n\r\n          -  Currently receiving RP treatment prescribed by a treating physician (e.g., CS,\r\n             colchicine)\r\n\r\n          -  Diagnosis of pericarditis secondary to tuberculosis (TB), cancer if not in full\r\n             remission, post thoracic blunt trauma (e.g., motor-vehicle accidents), myocarditis,\r\n             systemic autoimmune diseases except SJIA and adult Still's disease, HIV\r\n\r\n          -  Enrolled in a therapeutic investigational clinical trial during the observation period\r\n      ","sponsor":"Kiniksa Pharmaceuticals (UK), Ltd.","sponsor_type":"Industry","conditions":"Recurrent Pericarditis","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Patients using 1 or more RP treatments","time_frame":"5 years","description":"Proportion of patients using 1, 2, 3, or more concomitant RP treatments"},{"outcome_type":"secondary","measure":"Most frequently used RP treatments","time_frame":"5 years","description":"Number of subjects who used each treatment recorded during the study"},{"outcome_type":"secondary","measure":"Reduction in the use of corticosteroids","time_frame":"5 years","description":"Change from baseline through end of observation in corticosteroid use"},{"outcome_type":"secondary","measure":"Change in RP activity","time_frame":"1 year","description":"Change from baseline in RP disease recurrences within 1 year (from 1 year prior to baseline to 1 year after baseline"},{"outcome_type":"secondary","measure":"Change in pericardial rub","time_frame":"5 years","description":"Change from baseline in pericardial rub"},{"outcome_type":"secondary","measure":"Change in pericardial effusion","time_frame":"5 years","description":"Change from baseline in pericardial effusion"},{"outcome_type":"secondary","measure":"Change in fever","time_frame":"5 years","description":"Change from baseline in fever"},{"outcome_type":"secondary","measure":"Change in dyspnea","time_frame":"5 years","description":"Change from baseline in dyspnea"},{"outcome_type":"secondary","measure":"Change in C-reactive protein (CRP)","time_frame":"5 years","description":"Change from baseline in CRP"},{"outcome_type":"secondary","measure":"Change in erythrocyte sedimentation rate (ESR)","time_frame":"5 years","description":"Change from baseline in ESR"},{"outcome_type":"secondary","measure":"Change in white blood count (WBC)","time_frame":"5 years","description":"Change from baseline in WBC"},{"outcome_type":"secondary","measure":"Change in interleukin-1 (IL-1)","time_frame":"5 years","description":"Change from baseline in IL-1"},{"outcome_type":"secondary","measure":"Change in interleukin-6 (IL-6)","time_frame":"5 years","description":"Change from baseline in IL-6"},{"outcome_type":"secondary","measure":"Change in electrocardiogram (ECG)","time_frame":"5 years","description":"Change from baseline in ST-, PR-, QRS- and QT- intervals"},{"outcome_type":"secondary","measure":"Change in echocardiogram","time_frame":"5 years","description":"Change from baseline in echocardiogram"},{"outcome_type":"secondary","measure":"Change in chest x-ray","time_frame":"5 years","description":"Change from baseline in chest x-ray"},{"outcome_type":"secondary","measure":"Change in cardiac magnetic resonance imaging (cMRI)","time_frame":"5 years","description":"Change from baseline in cMRI"},{"outcome_type":"secondary","measure":"Change in cardiovascular magnetic resonance (CMR) imaging","time_frame":"5 years","description":"Change from baseline in CMR"},{"outcome_type":"secondary","measure":"Change in Multidetector (cardiac) computed tomography (MDCT)","time_frame":"5 years","description":"Change from baseline in MDCT"},{"outcome_type":"secondary","measure":"Adverse event rate","time_frame":"5 years","description":"Rate of adverse events reported by PC treatment"},{"outcome_type":"secondary","measure":"Changes in PROMIS-29 patient-reported outcomes","time_frame":"5 years","description":"Change from baseline in PROMIS-29"},{"outcome_type":"secondary","measure":"Changes in PROMIS Pediatric/Parent 25 patient-reported outcomes","time_frame":"5 years","description":"Change from baseline in PROMIS Pediatric/Parent 25"},{"outcome_type":"secondary","measure":"Changes in insomnia severity index (ISI) patient-reported outcomes","time_frame":"5 years","description":"Change from baseline in ISI"},{"outcome_type":"secondary","measure":"Changes in Patient Global Impression of Pericarditis Severity (PGIPS) patient-reported outcomes","time_frame":"5 years","description":"Change from baseline in PGIPS"},{"outcome_type":"secondary","measure":"Changes in persistent pericarditis numerical rating scale (PPNRS) patient-reported outcomes","time_frame":"5 years","description":"Change from baseline in PPNRS"},{"outcome_type":"secondary","measure":"Changes in D12 patient-reported outcomes","time_frame":"5 years","description":"Change from baseline in D12 outcome measures"}]}
{"nct_id":"NCT04498468","start_date":"2021-03-16","phase":"Phase 4","enrollment":85,"brief_title":"Safety and Efficacy of Dexamethasone Ophthalmic Insert (Dextenza) in the Management of Clinically Significant Dry Eye","official_title":"Safety and Efficacy of Dexamethasone Ophthalmic Insert (Dextenza) in the Management of Clinically Significant Dry Eye","primary_completion_date":"2022-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-12-31","last_update":"2021-03-17","description":"To determine efficacy and safety profile of dexamethasone 0.4mg lacrimal insert in dry eye related ocular surface inflammation.","other_id":"IRB00246348","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"Double","intervention_model_description":"Prospective, Double Masked, Interventional Study.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":100,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        A patient's study eye must meet the following criteria to be eligible for inclusion in the\r\n        study:\r\n\r\n          -  Male or Female Age 18-100\r\n\r\n          -  Capacity to give informed consent\r\n\r\n          -  Ability to follow study direction and complete all study visits\r\n\r\n          -  A previous or current diagnosis of dry eye by an eye care specialist, whereas\r\n             treatment is requiring the use of a topical steroid\r\n\r\n          -  Able to have a lacrimal plug placement into both lower puncta. If lower puncta are\r\n             already plugged or cauterized/sealed, upper puncta will be used\r\n\r\n          -  Females of childbearing potential unwilling to use reliable form(s) of birth control\r\n             throughout study period\r\n\r\n          -  Clinical diagnosis of dry eye syndrome (DES) or keratoconjunctivitis sicca (KCS), in\r\n             which the following has been bilaterally documented in the ophthalmic and medical\r\n             histories:\r\n\r\n             i. history/diagnosis of dry eye ii. has taken or is on prescription drops (including\r\n             but not limited to topical steroids, cyclosporine or lifitegrast)\r\n\r\n          -  Presence of all of the following in both eyes at Baseline (Day 1):\r\n\r\n             i. Total OSS of 3 or more with at least 2+ corneal staining (0-6) ii. Unanesthetized\r\n             Schirmer level of <10 mm at 5 minutes iii. Presence of significant symptoms defined as\r\n             30mm or higher score of (1) eye dryness, or (2) eye fatigue, or (3) eye discomfort as\r\n             measured using VAS, in both eyes. At the baseline visit, the most bothersome symptom\r\n             (of the three) will be determined and used as the main symptom outcome measure\r\n             throughout the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n        A patient who meets any of the following criteria will be excluded from the study:\r\n\r\n          -  Use of Contact lenses within 1 week of screening visit or during the study\r\n\r\n          -  Any ocular surgery (including tear duct cauterization) within the 3 months\r\n\r\n          -  Inability to place a lacrimal device into upper or lower puncta of both eyes (if upper\r\n             in R eye should be upper in the left eye and vice versa)\r\n\r\n          -  Inability to participate in the wash out period\r\n\r\n          -  Use of topical glaucoma medications (With exception of rescue medication)\r\n\r\n          -  Pregnancy, nursing or intention of pregnancy or nursing in the study period.\r\n\r\n          -  Monocular patients\r\n\r\n          -  Uncontrolled systemic disease (defined as frequent or recent change in the medication\r\n             regimen)\r\n\r\n          -  Patients who are currently on with stable doses of oral steroids, topical cyclosporine\r\n             or lifitigrast, topical tacrolimus or pimecrolimus are eligible as long as there has\r\n             been no change in the dose in the last 3 months\r\n\r\n          -  Patients who are on topical steroids (With exception of rescue medication) (Patients\r\n             who have used steroids recently but have been off for at least 2 weeks will be\r\n             eligible.)\r\n\r\n          -  Current enrollment in any other investigational drug or device study or participation\r\n             of study within 30 days of baseline visit.\r\n\r\n          -  Known allergy or sensitivity to any of the clinical or experimental drugs used in this\r\n             study including history of steroid response.\r\n      ","sponsor":"Johns Hopkins University","sponsor_type":"Other","conditions":"Dry Eye","interventions":[{"intervention_type":"Drug","name":"Drug: Sustained Release Dexamethasone, 0.4 mg","description":"dexamethasone 0.4mg lacrimal insert"},{"intervention_type":"Other","name":"Other: E-Caprolactone-L-Lactide copolymer (PCL) punctal plug","description":"Control eye will receive a tear duct plug without the dexamethasone (EXTENDED WEAR SYNTHETIC ABSORBABLE PUNCTAL PLUG made of E-Caprolactone-L-Lactide copolymer (PCL). Absorbs in 60 to 180 days. Size 0.5mm which is comparable to the study treatment)"}],"outcomes":[{"outcome_type":"primary","measure":"Efficacy Endpoint as assessed by dry eye sign using Ocular Surface Scale (OSS)","time_frame":"28 days","description":"OSS will be graded according to the Sjögren's International Collaborative Clinical Alliance (SICCA) grading system. Conjunctival staining will be evaluated 1st, using a neutral density filter over the light source after instillation of lissamine green dye. The nasal and temporal conjunctiva, within the interpalpebral fissure, will be graded separately (maximum score of 3 and minimum of 0 for each area). Corneal staining will be evaluated using the cobalt blue filter at least 2 minutes after instillation of fluorescein dye. Maximum possible fluorescein score (the punctate epithelial erosions grade + any extra points for modifiers [central staining, confluent staining, and filaments]) will be 6 and minimum of 0. The total possible maximum OSS, derived by summing the corneal and conjunctival scores, will be 12 for each eye.\r\nThe difference between the average corneal staining in the treated arm versus the average corneal staining in the sham arm will be compared statistically."},{"outcome_type":"primary","measure":"Patient reported symptom","time_frame":"42 Days","description":"Most bothersome symptom (any one of the (1)eye dryness, (2)eye discomfort, or (3)eye fatigue will be established as the most bothersome symptom at baseline for each eye) measured using visual analogue scale (0 to 100). The difference between the average most bothersome symptom in the treated arm versus the average most bothersome symptom in the sham arm will be compared statistically."},{"outcome_type":"secondary","measure":"Percentage of subjects achieving 1 severity grade improvement in corneal staining","time_frame":"42 days","description":"Corneal staining responder analysis. Responder is defined as one full severity grade improvement in corneal staining. The percentage of subjects achieving 1 severity grade improvement in corneal staining (responders) in the treated arm versus sham arm will be compared statistically."},{"outcome_type":"secondary","measure":"Percentage of subjects achieving a 30% improvement in their most bothersome symptom","time_frame":"42 days","description":"Symptom responder analysis. Responder is defined as 30% improvement in the most bothersome symptom. The percentage of subjects achieving a 30% improvement in their most bothersome symptom (responders) in the treated arm versus the sham arm will be compared statistically."},{"outcome_type":"other","measure":"Change in Safety Endpoint as assessed by Intraocular pressure","time_frame":"At day 30 and day 42","description":"Intraocular Pressure (IOP) measurement using applanation tonometry"}]}
{"nct_id":"NCT04688034","start_date":"2021-03-15","phase":"Phase 1","enrollment":6,"brief_title":"Safety and Tolerability Study of OP-724 in Liver Cirrhosis Patients by HIV/HCV With Hemophilia.","official_title":"Phase I Clinical Trial of CBP/Beta-catenin Inhibitor OP-724 in Liver Cirrhosis Patients Caused by HIV/HCV Co-infection With Hemophilia. (OP-724-H101)","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-12-31","last_update":"2021-03-30","description":"To evaluate the safety and tolerability of OP-724 in liver cirrhosis patients caused by HIV/HCV co-infection with hemophilia.","other_id":"OP-724-H101","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":20,"maximum_age":74,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        1. Hemophilia patients with liver cirrhosis caused by HIV/HCV co-infection that fall under\r\n        the following 1) and 2).\r\n\r\n          1. HIV-RNA positive in serum or HIV antibody positive patients (the amount of HIV-RNA in\r\n             the blood at the time of screening is less than 200 copies/mL, and the number of CD4\r\n             positive T lymphocytes can be maintained at 200/micro L or more).\r\n\r\n          2. HCV-RNA positive in serum or HCV antibody positive patients (regardless of the amount\r\n             of viral and treatment).\r\n\r\n        2. Patients with Child-Pugh class A or B.\r\n\r\n        3. Patients who meet at least one of 1) to 3) for diagnosis of liver cirrhosis.\r\n\r\n          1. FIB-4 index value is 3.25 or higher.\r\n\r\n          2. Liver hardness value by FibroScan is 11.8 kPa or more.\r\n\r\n          3. Abdominal CT scan shows changes in liver shape and/or portal hypertension symptoms.\r\n\r\n        4. Patients who meet any of 1) to 3) for anti-HCV therapy.\r\n\r\n          1. Patients who have not reached the sustained virological response (SVR) * with the\r\n             direct acting antivirals (DAA) therapy. * SVR shall be as SVR12 (persistent virus\r\n             negative at 12 weeks after the end of administration).\r\n\r\n          2. Patients who have difficulty in performing DAA therapy.\r\n\r\n          3. Patients who have passed 24 weeks or more after achieving SVR* with DAA therapy or IFN\r\n             therapy.\r\n\r\n        5. Patients with Performance Status 0-2.\r\n\r\n        6. Male patients aged 20 to under 75 at the time of obtaining written consent.\r\n\r\n        7. Patients who provided voluntary written consent to participate in this clinical trial.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients who have cirrhosis due to causes other than HCV, and patients whose cause of\r\n             cirrhosis is unknown.\r\n\r\n          2. Patients with esophagogastric varices who are judged to require treatment by endoscopy\r\n             at the time of screening.\r\n\r\n          3. Patients with complication or with previous history of primary liver cancer (excluding\r\n             patients who have been for more than 1 year after hepatoma removing operation or\r\n             radiofrequency ablation etc.).\r\n\r\n          4. Patients with complication or with previous history of malignant tumor (within 3 years\r\n             before screening).However, except for the following diseases: treated basal cell\r\n             carcinoma, treated lung carcinoma in situ, or well-controlled superficial\r\n             (non-invasive) bladder cancer.\r\n\r\n          5. Patients with active AIDS index disease requiring treatment.\r\n\r\n          6. Patients for whom HBV, HTLV-1 active viral infection or syphilis infection cannot be\r\n             ruled out.\r\n\r\n          7. Serum creatinine level: Patients over 1.5 times the upper limit of the facility\r\n             reference value.\r\n\r\n          8. Patients with complications with uncontrolled diabetes, hypertension or heart failure.\r\n\r\n          9. Patients with psychiatric disorders that may affect the conduct of clinical trial.\r\n\r\n         10. Patients with or have a history of serious allergies to contrast agent.\r\n\r\n         11. Patients who have not passed the following period at the time of registration and\r\n             after the end of anti-HCV therapy.\r\n\r\n               -  IFN preparation 12 weeks after the last administration\r\n\r\n               -  Ribavirin preparation 16 weeks after the last administration\r\n\r\n               -  16 weeks after the last administration of DAA\r\n\r\n         12. Patients whose dosage and administration have been changed within 12 weeks prior to\r\n             registration if the following treatments have been given.\r\n\r\n               -  Liver cirrhosis\r\n\r\n               -  HIV\r\n\r\n         13. Patients with a history of drug or alcohol intoxication within 5 years prior to\r\n             obtaining written consent, or patients with a history of drug or alcohol abuse within\r\n             the last 1 year.\r\n\r\n         14. Patients who participated in other clinical trials within 30 days before obtaining\r\n             written consent and used or had used investigational drugs or investigational medical\r\n             devices.\r\n\r\n         15. Patients who have undergone liver transplantation or other organ transplantation\r\n             (including bone marrow transplantation) and patients who have difficulty in\r\n             intravenous administration.\r\n\r\n         16. Male patients who do not consent to contraception from the time of consent acquisition\r\n             to 12 weeks after the end of study drug administration.\r\n\r\n         17. In addition, patients who are judged by the investigator or sub-investigator to be\r\n             ineligible for this study.\r\n      ","sponsor":"Kiminori Kimura, MD","sponsor_type":"Other","conditions":"Liver Cirrhosis","interventions":[{"intervention_type":"Drug","name":"Drug: OP-724","description":"Twice a week for 4 hours continuous intravenous administration of OP-724."}],"outcomes":[{"outcome_type":"secondary","measure":"Adverse Events","time_frame":"28 days after the last administration of OP-724.","description":"Occurrence rate of adverse events. The data will be aggregated by each cohort, seriousness and severity."},{"outcome_type":"secondary","measure":"Side Effects","time_frame":"28 days after the last administration of OP-724.","description":"Occurrence rate of side effects."},{"outcome_type":"primary","measure":"Serious Adverse Events (Side Effects)","time_frame":"28 days after the last administration of OP-724.","description":"Occurrence rate of serious adverse events whose causal relationship with the investigational drug cannot be ruled out (side effects). The data will be aggregated by each cohort."},{"outcome_type":"secondary","measure":"Parameters on Pharmacokinetics (OP-724 and C-82): Maximum Plasma Concentration (Cmax)","time_frame":"Single administration part: pre-dose and post-dose at 0.5, 1, 2, 4, 5, 9 and 24 hours.","description":"Cmax of OP-724 and C-82 will be determined."},{"outcome_type":"secondary","measure":"Parameters on Pharmacokinetics (OP-724 and C-82): Area Under the Curve from 0 to 24 hours (AUC0-24h)","time_frame":"Single administration part: pre-dose and post-dose at 0.5, 1, 2, 4, 5, 9 and 24 hours.","description":"AUC0-24 of OP-724 and C-82 will be determined."},{"outcome_type":"secondary","measure":"Parameters on Pharmacokinetics (OP-724 and C-82): Time to Maximum Plasma Concentration (Tmax)","time_frame":"Single administration part: pre-dose and post-dose at 0.5, 1, 2, 4, 5, 9 and 24 hours.","description":"Tmax of OP-724 and C-82 will be determined."},{"outcome_type":"secondary","measure":"Parameters on Pharmacokinetics (OP-724 and C-82): t1/2","time_frame":"Single administration part: pre-dose and post-dose at 0.5, 1, 2, 4, 5, 9 and 24 hours.","description":"t1/2 of OP-724 and C-82 will be determined."},{"outcome_type":"secondary","measure":"Drug Concentration (OP-724 and C-82) in Plasma","time_frame":"A) Single administration part: pre-dose and post-dose at 0.5, 1, 2, 4, 5, 9 and 24 hours. B) Continuous administration part: pre-dose and post-dose at 4 hours on Day 1 and 4 in Cycle 1, 5, 9 and 12 (each cycle is 7days).","description":"Graphing with time course of drug concentration."},{"outcome_type":"secondary","measure":"Drug Concentration (Integrase inhibitor) in Plasma","time_frame":"A) Single administration part: pre-dose and post-dose at 2, 4, 9 and 24 hours. B) Continuous administration part: pre-dose on Day 1 in Cycle 5, 9 and 12 (each cycle is 7days).","description":"Graphing with time course of drug concentration."},{"outcome_type":"secondary","measure":"Blood HIV-RNA Level","time_frame":"Baseline, Cycle5Day1, Cycle9Day1 and up to 12 weeks after administration (each cycle is 7days).","description":"Amount of change in blood HIV-RNA level from baseline at each measurement time point."},{"outcome_type":"secondary","measure":"CD4 Positive T Lymphocyte Count","time_frame":"Baseline, Cycle5Day1, Cycle9Day1 and up to 12 weeks after administration (each cycle is 7days).","description":"Amount of change in CD4 positive T lymphocyte count from baseline at each measurement time point."},{"outcome_type":"secondary","measure":"FibroScan","time_frame":"Baseline and 12 weeks after administration","description":"Amount of change from baseline in the measured value of liver tissue hardness by FibroScan at 12 weeks after administration."},{"outcome_type":"secondary","measure":"FIB-4 Index","time_frame":"Baseline and 12 weeks after administration","description":"Amount of change from baseline in FIB-4 index at 12 weeks after administration."},{"outcome_type":"secondary","measure":"APRI","time_frame":"Baseline and 12 weeks after administration","description":"Amount of change from baseline in APRI at 12 weeks after administration."},{"outcome_type":"secondary","measure":"Child-Pugh Score","time_frame":"Baseline and 12 weeks after administration","description":"Amount of change from baseline in Child-Pugh Score at 12 weeks after administration. Child Pugh score (scale range 5-15 points, the severity increases sequentially from 5 to 15 points) is obtained by adding the score for each parameter (hepatic encephalopathy, ascites, bilirubin, albumin, PT). Based on the total points score (Child-Pugh Score) of each diagnostic parameter shown above, the severity of the disease is classified into Grades A to C shown below.\r\nGrade A: 5-6 points -> Compensated cirrhosis\r\nGrade B: 7-9 points -> Decompensated cirrhosis\r\nGrade C: 10-15 points -> Decompensated cirrhosis"},{"outcome_type":"secondary","measure":"MELD Score","time_frame":"Baseline and 12 weeks after administration","description":"Amount of change from baseline in MELD score at 12 weeks after administration.\r\nThe Model for End-Stage Liver Disease (MELD) is a scoring system for assessing the severity of chronic liver disease and uses the subject's values for total bilirubin, serum creatinine, and the international normalized ratio (INR) for prothrombin time to predict survival. MELD is calculated according to the following formula:\r\n* MELD score = 3.78×ln[serum bilirubin (mg/dL)] + 11.2×ln[INR] + 9.57×ln[serum creatinine (mg/dL)] + 6.43"}]}
{"nct_id":"NCT04777032","start_date":"2021-03-15","enrollment":600,"brief_title":"The Danish Comorbidity in Liver Transplant Recipients Study","official_title":"The Danish Comorbidity in Liver Transplant Recipients Study (DACOLT) - a Non-interventional Prospective Observational Cohort Study","primary_completion_date":"2022-03-15","study_type":"Observational","rec_status":"Not yet recruiting","completion_date":"2043-01-01","last_update":"2021-03-02","description":"Background: Liver transplantation is the only curative treatment for patients with end-stage liver disease. Short-term survival has improved due to improved surgical techniques and greater efficacy of immunosuppressive drugs. At present, the 10-year survival after liver transplantation is 60%, but long-term survival has not improved to the same extent the short-term survival. In addition to liver- and transplant-related causes, comorbidities such as cardiovascular, pulmonary, renal, and metabolic diseases have emerged as leading causes of morbidity and mortality in liver transplant recipients. The objective of this study is to assess the burden of comorbidities and identify both liver- and transplant-related risk factors as well as traditional risk factors that contribute to the pathogenesis of comorbidity in liver transplant recipients. Methods/design: The DACOLT study is an observational, longitudinal study. The investigators aim to include all adult liver transplant recipients in Denmark. Participants will be matched by sex and age to controls from the Copenhagen General Population Study (CGPS) and the Copenhagen City Heart Study (CCHS). Physical and biological measures including blood pressure, ancle-brachial index, spirometry, exhaled nitric oxide, electrocardiogram, transthoracic echocardiography, computed tomography (CT) angiography of the heart, unenhanced CT of chest and abdomen and blood samples will be collected using uniform protocols in participants in CGPS, CCHS and DACOLT. Blood samples will be collected and stored in a research biobank. Follow-up examinations at regular intervals up to 10 years of follow-up are planned. Discussion: There is no international consensus standard for optimal clinical care or monitoring of liver transplant recipients. The study will determine prevalence, incidence and risk factors for comorbidity in liver transplant recipients and may be used to provide evidence for guidelines on screening and long-term treatment and thereby contribute to improvement of the long-term survival.","other_id":"Sponsor1 - Rigshospitalet","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":16,"maximum_age":100,"population":"All liver transplanted individuals in Danmark.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Liver transplanted\r\n\r\n          -  age between 16 and 100 years\r\n\r\n          -  be able to understand the study information in either Danish or English and to be able\r\n             to provide an informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  none\r\n      ","sponsor":"Rigshospitalet, Denmark","sponsor_type":"Other","conditions":"Liver Transplantation|Comorbidities and Coexisting Conditions","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Renal function","time_frame":"Baseline cross-sectional data","description":"Estimated glomerular filtration rate"},{"outcome_type":"primary","measure":"Cardiac structure","time_frame":"Baseline cross-sectional data","description":"Assessed by cardiac computed tomography (CT)"},{"outcome_type":"primary","measure":"Change in Cardiac structure","time_frame":"10 years follow-up","description":"Assessed by cardiac computed tomography (CT)"},{"outcome_type":"primary","measure":"Change in Renal function","time_frame":"10 years follow-up","description":"Estimated glomerular filtration rate"},{"outcome_type":"primary","measure":"Cardiac function","time_frame":"Baseline cross-sectional data","description":"Assessed by cardiac computed tomography (CT)"},{"outcome_type":"primary","measure":"Change in Cardiac function","time_frame":"10 years follow-up","description":"Assessed by cardiac computed tomography (CT)"},{"outcome_type":"primary","measure":"Metabolic diseases","time_frame":"Baseline cross-sectional data","description":"Prevalence of Diabetes"},{"outcome_type":"primary","measure":"Metabolic diseases","time_frame":"10 years follow-up","description":"Change in Diabetes"},{"outcome_type":"primary","measure":"Metabolic diseases","time_frame":"Baseline cross-sectional data","description":"Prevalence of Dyslipidaemia"},{"outcome_type":"primary","measure":"Metabolic diseases","time_frame":"10 years follow-up","description":"Change in Dyslipidaemia"},{"outcome_type":"primary","measure":"Change in cardiac structure","time_frame":"10 years follow-up","description":"Determined by transthoracic echocardiography"},{"outcome_type":"primary","measure":"Dynamic lung function indices assessed by spirometry","time_frame":"Baseline cross-sectional data","description":"FVC and FEV1 assessed by spirometry"},{"outcome_type":"primary","measure":"Change in Dynamic lung function indices assessed by spirometry","time_frame":"10 years follow-up","description":"FVC and FEV1 assessed by spirometry"},{"outcome_type":"primary","measure":"Prevalence of coronary artery disease","time_frame":"Baseline cross-sectional data","description":"Assessed by coronary CT angiography"},{"outcome_type":"primary","measure":"Change in Coronary artery disease","time_frame":"10 years follow-up","description":"Assessed by coronary CT angiography"},{"outcome_type":"primary","measure":"Cardiac function","time_frame":"Baseline cross-sectional data","description":"Determined by transthoracic echocardiography"},{"outcome_type":"primary","measure":"Change in Cardiac function","time_frame":"10 years follow-up","description":"Determined by transthoracic echocardiography"},{"outcome_type":"primary","measure":"Cardiac structure","time_frame":"Baseline cross-sectional data","description":"Determined by transthoracic echocardiography"},{"outcome_type":"secondary","measure":"Prevalence of Depression","time_frame":"Baseline cross sectional data","description":"Major Depression Inventory (MDI): A depression questionnaire. The questionnaire consists of the ten symptoms contained in the World Health Organization WHO's depression demarcation. The patient's completed questionnaire is scored using a scoring key.\r\nWhen MDI is used as a rating scale in the same way as the Hamilton scales, then the sum of the ten questions indicates the degree of depression. The theoretical score range is from 0 (no depression) to 50 (maximum depression).\r\nMild depression: MDI total score from 21 to 25 Moderate depression: MDI total score from 26 to 30 Severe depression: MDI total score of 31 or higher"},{"outcome_type":"secondary","measure":"Change in Depression","time_frame":"10 years follow-up","description":"Major Depression Inventory (MDI): A depression questionnaire. The questionnaire consists of the ten symptoms contained in the World Health Organization WHO's depression demarcation. The patient's completed questionnaire is scored using a scoring key.\r\nWhen MDI is used as a rating scale in the same way as the Hamilton scales, then the sum of the ten questions indicates the degree of depression. The theoretical score range is from 0 (no depression) to 50 (maximum depression).\r\nMild depression: MDI total score from 21 to 25 Moderate depression: MDI total score from 26 to 30 Severe depression: MDI total score of 31 or higher"},{"outcome_type":"secondary","measure":"Fracture risk","time_frame":"Baseline cross sectional data","description":"FRAX® score. The FRAX® tool has been developed to evaluate fracture risk of patients. It is based on individual patient models that integrate the risks associated with clinical risk factors.\r\nThe FRAX® algorithms give the 10-year probability of fracture. The output is a 10-year probability of hip fracture and the 10-year probability of a major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture)."},{"outcome_type":"secondary","measure":"Change in Fracture risk","time_frame":"10 year follow-up","description":"FRAX® score. The FRAX® tool has been developed to evaluate fracture risk of patients. It is based on individual patient models that integrate the risks associated with clinical risk factors.\r\nThe FRAX® algorithms give the 10-year probability of fracture. The output is a 10-year probability of hip fracture and the 10-year probability of a major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture)."},{"outcome_type":"secondary","measure":"Obstructive pulmonary disease","time_frame":"Baseline cross sectional data","description":"Nitric oxide in exhaled breath"},{"outcome_type":"secondary","measure":"Obstructive pulmonary disease","time_frame":"10 year follow-up","description":"Change in Nitric oxide in exhaled breath"},{"outcome_type":"secondary","measure":"Prevalence of Peripheral artery disease","time_frame":"Baseline cross sectional data","description":"Ankle-brachial-index (ABI) is measured using a Doppler meter by determining the systolic pressure in the arm and ankle."},{"outcome_type":"secondary","measure":"Change in Peripheral artery disease","time_frame":"10 years follow-up","description":"Ankle-brachial-index (ABI) is measured using a Doppler meter by determining the systolic pressure in the arm and ankle."}]}
{"nct_id":"NCT04340492","start_date":"2021-03-15","phase":"N/A","enrollment":90,"brief_title":"Education for Adapted Physical Activity in Parkinson's Disease","official_title":"Effectiveness of Adapted Physical Activity Education on Physical Activity Daily in Patients With Parkinson's Disease at an Early Stage","primary_completion_date":"2024-05-31","study_type":"Interventional","rec_status":"Enrolling by invitation","completion_date":"2024-05-31","last_update":"2021-04-29","description":"Parkinson's disease is a progressive disorders characterized by motor and non-motor symptoms. Actual medical treatments are symptomatic and have little efficacy on late stage axial motor symptoms. Non-pharmacological approaches are therefore essential from the disease onset. Beside physiotherapy, to practice a regular adapted physical activity is crucial. To implement such a practice in everyday life implies to change habits. Patient Education programs are useful tools to help changing behaviors. The study evaluate the effect of a program aiming to promote adapted physical activity in early stage Parkinson's disease by comparing patients receiving the program and patients on a waiting list. The hypothesis that the program will increase the one-week mean daily moderate to intense physical activity as measured with an actimeter.","other_id":"2018_91","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":30,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  suffering from Parkinson's disease according to Movement Disorders Society criteria,\r\n\r\n          -  with a diagnosis of Parkinson for 3 years or less,\r\n\r\n          -  with a stable treatment for Parkinson's disease for 3 months or more,\r\n\r\n          -  having signed the consent form\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Woman child-bearing or breath-feeding\r\n\r\n          -  Co-morbidities that influence or contraindicated adapted physical activity (severe\r\n             respiratory symptoms, cardiopathy)\r\n\r\n          -  Major depressive disorder according to DSM-V\r\n\r\n          -  Significant cognitive trouble (MOCA<23)\r\n\r\n          -  Atypical parkinson's\r\n      ","sponsor":"University Hospital, Lille","sponsor_type":"Other","conditions":"Parkinson Disease","interventions":[{"intervention_type":"Other","name":"Other: Education to Adapted Physical Activity","description":"4 group sessions (5 patients) aiming at promoting physical activity, the first three focusing respectively on endurance, posture and balance and power re-enforcement at one-week interval. A fourth session, 3 months latter is a consolidating session aiming at identify and overcome obstacles to practice physical activity in everyday life."},{"intervention_type":"Other","name":"Other: Standard care","description":"Standard care concerning Parkinson's disease and physical activity"}],"outcomes":[{"outcome_type":"primary","measure":"Change in time spent in moderate to vigorous physical activity during one week","time_frame":"between baseline and 6 months after baseline","description":"Daily physical activity is assessed with an actimeter (Actigraph GT9X)."},{"outcome_type":"secondary","measure":"Change in fatigue as assessed with the Parkinson Fatigue Scale (PFS)","time_frame":"between baseline and 6 months after baseline","description":"This is a self-evaluation questionnaire, the physical aspects of fatigue and its influence on the everyday functionality and activity. An indication of the presence of clinically relevant fatigue is provided by the mean value calculated from the 16 items. A mean value of > 2.95 indicates the presence of fatigue symptoms"},{"outcome_type":"secondary","measure":"Change in quality of life as assessed with the PDQ-39 scale","time_frame":"between baseline and 6 months after baseline","description":"Parkinson's Disease Quality of Life Questionnaire (PDQ-39): the 39-Item Parkinson's Disease Questionnaire (PDQ-39) is a commonly used measure of self-appraisal in PD. It is a measure of health status and quality of life, by assessing difficulties in 8 dimensions of daily living: mobility (10 items), activities of daily living (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognition (4 items), communication (3 items) and bodily discomfort (3 items). The frequency of each event is determined by selecting one of 5 options: never (scored 0) / occasionally (scored 1) / sometimes (2) / often (3) / always (4). Each dimension total score range from 0 to 100, with lower scores reflecting better quality of life."},{"outcome_type":"secondary","measure":"Change in Non-motor symptoms as assessed with the Non Motor Symptoms Scale (NMSS)","time_frame":"between baseline and 6 months after baseline","description":"Non-motor symptoms scale for Parkinson's disease (NMSS). Non-motor symptoms are assessed over the last month. Each symptom is scored with respect to:\r\nSeverity: 0 = None; 1 = Mild: symptoms present but causes little distress or disturbance to patient; 2 = Moderate: some distress or disturbance to patient; 3 = Severe: major source of distress or disturbance to patient.\r\nFrequency: 1 = Rarely (<1/wk); 2 = Often (1/wk); 3 = Frequent (several times per week); 4 = Very Frequent (daily or all the time).\r\nNMSS contains nine dimensions: cardiovascular (2 items), sleep/fatigue (4 items), mood/cognition (6 items), perceptual problems (3 items), attention/memory (3 items), gastrointestinal (3 items), urinary (3 items), sexual function (2 items), and miscellaneous (4 items).\r\nSubscores are calculated through multiplication of frequency x severity. Total score is calculated by adding all subscores, range 0-360."},{"outcome_type":"secondary","measure":"Percentage of patients that complete all four sessions of the program","time_frame":"At 3 months ( duration of the program)"},{"outcome_type":"secondary","measure":"Change in physical activity during one week, assessed with the International Physical Activity Questionnaire (IPAQ)","time_frame":"between baseline and 6 months after baseline","description":"The International Physical Activity Questionnaire (IPAQ) short form measures walking, moderate- and vigorous intensity, and total PA and daily time spent sitting on weekdays. PA was reported in MET·minutes/week and days per week and was scored using standardized IPAQ scoring protocols to yield total metabolic equivalent minutes (MET·minutes/week) of PA per week. Sitting time was reported as the amount of time in hours and/or minutes participants spent sitting on a weekday during the past seven days."},{"outcome_type":"secondary","measure":"Change in Motor symptoms as assessed with the MDS-UPDRS-3","time_frame":"between baseline and 6 months after baseline","description":"The Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III. MDS-UPDRS Part III measures motor examination. Part III consists of 33 scores based on 18 items, and each question is anchored with five response scale from 0(normal) to 4(severe)."}]}
{"nct_id":"NCT04835675","start_date":"2021-03-12","enrollment":496,"brief_title":"AssesSment of Early-deteCtion basEd oN liquiD Biopsy in Hepatobiliary Cancer Malignancies","official_title":"Development and Validation of the Performance of a cfDNA Methylation-based Model Combined With Serum Tumor Markers for Early Hepatobiliary Malignancies Detection","primary_completion_date":"2022-03-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2022-06-30","last_update":"2021-04-08","description":"This study is a prospective, multicenter study aimed to develop and validate the performance of combined assays for cfDNA methylation markers and serum tumor markers in early hepatobiliary malignancies detection. Circulating tumor DNA (ctDNA) mutation, blood RNA markers and tissue will also be evaluated. The study will enroll approximately 496 participants, including participants with malignant or benign diseases of the hepatobiliary system.","other_id":"ZJYY-2020006","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":40,"maximum_age":75,"population":"Eligible participants will be recruited from medical centers and assigned into two arms,\r\n        including participants with new diagnosis of hepatobiliary malignancies and benign diseases\r\n        of the hepatobiliary system.","criteria":"\n        Inclusion Criteria for All the Participants:\r\n\r\n          -  40-75 years old\r\n\r\n          -  Ability to comply with study procedures\r\n\r\n          -  Ability to provide a written informed consent\r\n\r\n        Exclusion Criteria for All the Participants:\r\n\r\n          -  Pregnancy or lactating women\r\n\r\n          -  Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow\r\n             transplant or stem cell transplant\r\n\r\n          -  Recipients of blood transfusion within 7 days prior to study blood draw\r\n\r\n          -  Recipients of anti-microbial therapy within 14 days prior to study blood draw\r\n\r\n          -  Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to\r\n             diseases other than cancer\r\n\r\n        Inclusion Criteria for Cancer Arm Participants:\r\n\r\n          -  Confirmed diagnosis or highly suspicious cases of hepatobiliary malignancies\r\n\r\n          -  No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood\r\n             draw\r\n\r\n        Exclusion Criteria for Cancer Arm Participants:\r\n\r\n          -  Current diagnosis of other malignancies or multiple primary tumors\r\n\r\n          -  Diagnosis of benign diseases by histopathological assessments\r\n\r\n          -  Inability to characterize whether the lesion is malignant or benign\r\n\r\n          -  Prior or ongoing treatment of cancer\r\n\r\n        Inclusion Criteria for Benign Diseases Arm Participants:\r\n\r\n          -  Confirmed diagnosis of benign diseases of the hepatobiliary system\r\n\r\n          -  No prior radical treatment of the benign diseases prior to study blood draw\r\n\r\n        Exclusion Criteria for Benign Diseases Arm Participants:\r\n\r\n          -  Current or history of malignancies or precancerous lesions\r\n\r\n          -  No confirmed diagnosis or inability to characterize a benign disease\r\n      ","sponsor":"Zhujiang Hospital","sponsor_type":"Other","conditions":"Hepatobiliary Malignancies","interventions":[{"intervention_type":"Device","name":"Device: Multi-cancer early detection test","description":"Blood collection and multi-cancer early detection testing"}],"outcomes":[{"outcome_type":"primary","measure":"Sensitivity of early hepatobiliary malignancies detection and Tissue of origin (TOO) accuracy of a cfDNA methylation-based model combined with serum tumor markers when specificity was 90%, 95% or 98%","time_frame":"16 months"},{"outcome_type":"primary","measure":"Sensitivity and specificity of early hepatobiliary malignancies detection and TOO accuracy of a cfDNA methylation-based model combined with serum tumor markers","time_frame":"16 months"},{"outcome_type":"secondary","measure":"Sensitivity and specificity of a cfDNA methylation-based model combined with serum tumor markers in early detection of hepatobiliary malignancies in different stages","time_frame":"16 months"},{"outcome_type":"secondary","measure":"Sensitivity and specificity of a cfDNA methylation-based model combined with serum tumor markers, clinical characteristics and other biomarkers","time_frame":"16 months"},{"outcome_type":"secondary","measure":"Sensitivity and specificity of a cfDNA methylation-based model combined with serum tumor markers in participants with malignant or benign diseases of the hepatobiliary system","time_frame":"16 months"},{"outcome_type":"secondary","measure":"Sensitivity and specificity of a cfDNA methylation-based model or serum tumor markers in participants with hepatobiliary malignancies","time_frame":"16 months"}]}
{"nct_id":"NCT04885192","start_date":"2021-03-11","enrollment":200,"brief_title":"Implementation and Evaluation of a Stepped-Care Mental Health Treatment Program for Patients With Chronic Pain","official_title":"Implementation and Evaluation of a Virtually-Delivered, Stepped-Care Mental Health Treatment Program for Patients With Chronic Pain During COVID-19","primary_completion_date":"2021-09-30","study_type":"Observational","rec_status":"Recruiting","completion_date":"2022-01-11","last_update":"2021-05-13","description":"Chronic pain affects nearly 20% of Canadians, and sixty percent or more of individuals with chronic pain are also struggling with mental health or substance use disorders (referred to as complex chronic pain, or CCP, patients). This is a major concern in the best of times and has become an emergency during the COVID-19 pandemic. Now individuals suffering from chronic pain are faced with the additional challenges of quarantine, including the stress of isolation, delays in much needed medical care, and anxiety of possible infection to self or loved ones. Prior to COVID-19, psychologists at The Transitional Pain Service and the GoodHope Ehlers-Danlos Syndrome Clinic at Toronto General Hospital have adapted gold standard treatments for mental health and substance use for the unique needs of individuals with CCP. The investigators propose to develop these treatments into a virtual intervention that will meet the needs of patients during and after the COVID-19 pandemic. The investigators will use a mobile health application (called Manage My Pain or MMP) already in use by our patients to identify patients with CCP currently struggling with mental health issues or at risk of opioid misuse. Patients identified at risk will be offered a single-session Acceptance and Commitment Therapy workshop and then reassessed one month after the workshop. Patients still reporting high levels of emotional distress or substance use risk at that time will be offered a six-week Dialectic Behavior Therapy-informed group and will be reassessed one month after conclusion of the group. The investigators propose to conduct prospective data collection during the implementation of this program to facilitate 1) evaluation of the impact of stepped-care program components on mental health and substance use concerns, 2) examination of current rates mental health and substance use concerns in patients, and 3) examination of uptake for virtual mental health care amongst patients with chronic pain.","other_id":"20-6290","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":80,"population":"All patients currently being followed by the GoodHope Ehlers Danlos Syndrome Program or the\r\n        Transitional Pain Service at Toronto General Hospital.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age: 18-80\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Limited comprehension of English\r\n\r\n          -  Known history of serious mental illness (e.g., schizophrenia, dissociative identity\r\n             disorder)\r\n\r\n          -  Cognitive deficits due to dementia that may affect comprehension (and thereby may\r\n             limit benefit of the intervention)\r\n      ","sponsor":"University Health Network, Toronto","sponsor_type":"Other","conditions":"Chronic Pain","interventions":[{"intervention_type":"Other","name":"Other: Stepped-Care Model","description":"Step 0: Screening via Manage My Pain (MMP) App. Patients using MMP will be prompted to complete questionnaires on pain catastrophizing, depressive symptoms, anxiety, suicide risk and opioid risk. Those scoring above clinical risk cut-offs will be referred to Step 1.\r\nStep 1: Acceptance and Commitment Therapy (ACT) Workshop. Patients will be offered a virtual ACT workshop focusing on practical coping skills for dealing with pain, emotional dysregulation, and disability, while maximizing functioning and quality of life with chronic pain. Thirty days later, patients will be prompted to complete all questionnaires through MMP again; those who score above clinical risk cut-offs will be referred to Step 2.\r\nStep 2: Dialectic Behavior Therapy (DBT) group. A 6-week DBT-based skills group will cover topics such as self-compassion, radical acceptance, distress tolerance, and mindfulness, among others. Thirty days later, patients will be prompted to complete questionnaires through MMP."}],"outcomes":[{"outcome_type":"primary","measure":"Change in Pain Medication Misuse","time_frame":"Baseline to post-intervention (3.5 months)","description":"Measured using the Opioid Risk Tool (ORT). The ORT is a brief self-report tool for assessing risk for opioid misuse/abuse. Patients are asked to acknowledge (yes/no) the presence of Opioid Use risk factors, including family history of substance use, personal history of substance use, age between 16-45, history of preadolescent sexual abuse, and current psychological disorder. Each item is assigned a point value, which differs by respondent gender, and the points for each affirmative response are summed to create a total score. A score of 9 or above has been validated as a marker for increased risk for opioid use disorder for individuals with chronic pain on opioid therapy"},{"outcome_type":"primary","measure":"Change in Pain Catastrophizing","time_frame":"Baseline to post-intervention (3.5 months)","description":"Measured using the Pain Catastrophizing Scale (PCS). The PCS is a 13-item self-report scale that measures a negative cognitive orientation toward pain, featuring helplessness, magnification, and rumination. Patients are asked to rate the degree to which each statement applies to them on a scale from 0, never, to 4, all the time. A total score of 24 or above has been validated as clinical cut off indicating increased risk of negative pain-related outcomes, mental health issues, and opioid misuse/abuse for individuals with chronic pain."},{"outcome_type":"primary","measure":"Change in Depression","time_frame":"Baseline to post-intervention (3.5 months)","description":"Measured using the Patient Health Questionnaire - 9 (PHQ-9). The PHQ-9 is a 9-item scale designed to capture symptoms of major depressive disorder. Respondents are asked to rate the frequency at which they experience 9 symptoms of depression (e.g. \"little interest or pleasure in doing things\", \"feeling down, depressed, or hopeless\") over the past two weeks on a scale from 0, not at all, to 3, nearly every day. Items are summed to create a total score. Clinical cut offs of 5 (mild depression), 10 (moderate depression), and 15 (severe depression) have been determined and validated. The PHQ-9 has been extensively validated for use with chronic pain patients and has also been identified as a risk factor for opioid misuse in this population."},{"outcome_type":"primary","measure":"Change in Anxiety","time_frame":"Baseline to post-intervention (3.5 months)","description":"Measured using the Generalized Anxiety Disorder - 7 (GAD-7). The GAD-7 is a 7-item self-report measure of generalized anxiety. Patients are asked to rate the frequency at which they experience 7 symptoms of generalized anxiety (e.g. \"feeling nervous, anxious, or on edge\", \"not being able to stop or control worrying\") over the past two weeks on a scale from 0, not at all, to 3, nearly every day. Clinical cut offs of 5 (mild anxiety), 10 (moderate anxiety), and 15 (severe anxiety) have been determined and validated. This scale has previously been validated as a measure of anxiety symptoms for individuals with chronic pain."},{"outcome_type":"primary","measure":"Change in Suicidal Behaviour","time_frame":"Baseline to post-intervention (3.5 months)","description":"Measured using the Suicide Behaviour Questionnaire - Revised (SBQ-R). The SBQ-R is a 4-item self-report measure of suicide risk. Patients are asked about past suicidal behaviour, current suicidal ideation, communication of suicidal ideation, and perceived likelihood of a future suicide attempt. Responses are summed to create a total score ranging from 3-18. A clinical cut-off of 11 has been recommended as a marker of increased suicide risk."},{"outcome_type":"secondary","measure":"Change in Pain Intensity","time_frame":"Baseline to post-intervention (3.5 months)","description":"Pain Numerical Rating Scales"},{"outcome_type":"secondary","measure":"Uptake of the Stepped Care Mental Health Treatment Program","time_frame":"March 2021 to August 2021","description":"Percentage of those who screen positive that attend a session"},{"outcome_type":"secondary","measure":"Change in Pain Interference","time_frame":"Baseline to post-intervention (3.5 months)","description":"Measured using the PROMIS Pain Interference Scale 8a. The PROMIS Pain Interference Scale 8a is an eight item self-report measure of pain interference in physical, mental, and social health. Patients are asked to rate the extent to which pain interferes in activities on a scale from 0, not at all, to 5, very much. Responses can be summed to create a total score or compared. The PROMIS pain interference measure has been validated for use as a measure of functioning for individuals with chronic pain."}]}
{"nct_id":"NCT04751279","start_date":"2021-03-09","enrollment":80,"brief_title":"Expression and Role of the JAK/STAT Pathway in Sarcoidosis Granuloma Cells","official_title":"Expression and Role of the JAK/STAT Pathway in Sarcoidosis Granuloma Cells","primary_completion_date":"2024-01-01","study_type":"Observational","rec_status":"Recruiting","completion_date":"2024-01-02","last_update":"2021-05-19","description":"Recent studies suggest that the JAK/STAT signaling pathway constitutes a new step in the clinical and therapeutic progress of sarcoidosis. Further investigations are necessary to identify the most suitable patients to receive treatment targeting this pathway, in particular in cases of severe sarcoidosis refractory to the various therapeutic lines.","other_id":"APHP201205","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":80,"population":"Patients with a diagnosis of mediastinopulmonary sarcoidosis, including recent versus\r\n        persistant disease (>5years) or active versus inactive disease.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with a diagnosis of mediastinopulmonary sarcoidosis made according to ATS /\r\n             ERS / WASOG criteria\r\n\r\n          -  Or patient suspected of having mediastino-pulmonary sarcoidosis, without any other\r\n             probable causal factor identified on the usual standard examination at the time of the\r\n             sample with the need for diagnostic confirmation at the end of the study according to\r\n             the criteria of the ATS / ERS / WASOG\r\n\r\n          -  Sarcoidosis with stage 1 to 4 pulmonary involvement\r\n\r\n          -  Patients who had a chest CT scan in the 6 months preceding the sample. Examination\r\n             carried out as part of routine care\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnancy.\r\n\r\n          -  Opposition expressed to participation in the study.\r\n\r\n          -  Patients on State Medical Aid.\r\n      ","sponsor":"Assistance Publique - Hpitaux de Paris","sponsor_type":"Other","conditions":"Sarcoidosis|JAK-STAT Pathway Deregulation","interventions":[{"intervention_type":"Other","name":"Other: Blood sample","description":"Blood sample collection of 5 blood sample at the inclusion in the study the samle consite of 5 tubesEthylene Diamine Tetra Acetate (ADTA) of 7 ml"}],"outcomes":[{"outcome_type":"primary","measure":"JAK/STAT familly numbers protein expression in PBMCs","time_frame":"1 year after inclusion","description":"Evaluation will be carried out by:\r\n- studying the expression of members of the JAK/STAT pathway, the expression of cytokines and chemokines phagocytosis and macrophage differentiation the expression of cytokines and chemokines"}]}
{"nct_id":"NCT04879901","start_date":"2021-03-09","phase":"N/A","enrollment":30,"brief_title":"Changes in Shoulder Muscle Activation According to the Methods of Carrying Backpacks","official_title":"Changes in Muscle Activation of Serratus Anterior, Deltoid (Anterior) and Trapezius (Upper and Lower) According to the Methods of Carrying Backpacks","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Enrolling by invitation","completion_date":"2021-12-31","last_update":"2021-08-20","description":"To investigate change of shoulder muscles by measuring muscle activity according to the position of the backpack.","other_id":"BundangCHA","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":59,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy adults from 20s to 50s\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Restriction of joint motion range of shoulder and elbow\r\n\r\n          -  Hisory of upper limb surgery in the past 6 months\r\n\r\n          -  If there is an external wire such as a temporary external pacemaker or central line\r\n             guide wire\r\n      ","sponsor":"CHA University","sponsor_type":"Other","conditions":"Shoulder Muscle Activation|Surface Emg","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: surface EMG","description":"surface EMG estimation with Carrying backpacks forward or backward"}],"outcomes":[{"outcome_type":"primary","measure":"Root mean square of each muscle activation","time_frame":"through study completion, an average of 1 year","description":"Quantification of muscle activation"}]}
{"nct_id":"NCT04824638","start_date":"2021-03-08","phase":"Phase 2","enrollment":267,"brief_title":"BNT162b2 Vaccination With Two Doses in COVID-19 Negative Adult Volunteers and With a Single Dose in COVID-19 Positive Adult Volunteers","official_title":"A Phase II Trial Assessing Immunogenicity and Safety of COVID-19 mRNA Vaccine BNT162b2 in Adult Volunteers With no History of SARS-CoV-2 Infection Administered With Two Doses of Vaccine (D1-D29) and in Adult Volunteers With Documented History of SARS-CoV-2 Infection (of More Than 5 Months) Administered With Only One Dose of Vaccine","primary_completion_date":"2021-06-29","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2023-10-30","last_update":"2021-08-09","description":"As previously shown, individuals who experienced COVID-19 have developed some protective immunity to reinfection. The magnitude and duration of protection from reinfection conferred by the infection may be weaker after an asymptomatic infection as it is after a symptomatic COVID-19 episode. Moreover, it is known that immunity decreases among older adults compared to younger individuals often referred to as ''immune senescence,'' and leading to a decreased efficacy of vaccination. This study raises the question of whether a single administration of BNT162b2 in participants with prior SARS-CoV-2 infection leads to sufficient and durable immune response. We propose to evaluate the level of the single BNT162b2 vaccine dose response according to the severity of the previous SARS-CoV-2 infection in young and elderly participants with the same immunogenicity analyses to assess this response in participants receiving the two-dose vaccination regimen.","other_id":"ANRS0002S","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","intervention_model_description":"Participants of group 1 will receive two administrations of BNT162b2 at D1 and D29 Participants of group 2 will receive one administration of BNT162b2 at D1 and D29","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. 18 to 45 years old or at least 65 years old,\r\n\r\n          2. Healthy adults or stable medical condition for adults with pre-existing medical\r\n             conditions. A stable medical condition is defined as disease not requiring significant\r\n             change in therapy or hospitalization for worsening disease during 3 months before\r\n             enrolment, nor expected to require any significant change in therapy or\r\n             hospitalization for worsening disease in foreseeable future.\r\n\r\n          3. Group 1: Healthy adults with no previous history of SARS COV2 infection (PCR-,\r\n             antigenic test- or chest TDM- or serology SARS-CoV-2-) Group 2: Healthy adults with\r\n             history of infection with SARS COV 2 (PCR+, antigenic test+ or chest TDM+ or serology\r\n             SARS-CoV-2 of more than 5 months) OR have been a household contact subject and have\r\n             presented COVID-19 symptoms [Experienced at least TWO of the following systemic\r\n             symptoms: Fever ( 38C), chills, myalgia, headache, sorethroat, new olfactory and\r\n             taste disorder(s), gastrointestinal symptoms (diarrhea and/or vomiting) or at least\r\n             ONE of the following respiratory signs/symptoms: cough, shortness of breath or\r\n             difficulty breathing, OR clinical or radiographical evidence of pneumonia] since at\r\n             least 5 months ago and have had a positive SARS-CoV-2 serology between this episode\r\n             and pre-inclusion.\r\n\r\n          4. A female participant is eligible to participate if she is not pregnant or\r\n             breastfeeding and one of the following conditions applies:\r\n\r\n               -  Is of non-childbearing potential. To be considered of non-childbearing potential,\r\n                  a female must be post-menopausal for at least 1 year or surgically sterile. OR\r\n\r\n               -  Is of childbearing potential and agrees to use an effective contraceptive method\r\n                  from at least 4 weeks prior to vaccination until at least 4 weeks after the last\r\n                  vaccination. A participant of childbearing potential must have a negative blood\r\n                  pregnancy test at enrolment visit.\r\n\r\n          5. Understands and agrees to comply with the study procedures (visits, phone calls) based\r\n             on Investigator judgement\r\n\r\n          6. Written and informed consent signed by the person and the investigator (no later than\r\n             the day of pre-inclusion and prior to any examination realized in the frame of the\r\n             trial) (article L1122-1-1 of the Public Health Code)\r\n\r\n          7. Affiliated or beneficiary of a social security scheme (article L1121-11 of the Public\r\n             Health Code) (AME is not a social security scheme)\r\n\r\n          8. who agrees to be registered in the national file of persons who lend themselves to\r\n             biomedical research (article L1121-16 of the Public Health Code).\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Participant is ill or febrile (body temperature  38.0C) within 72 prior hours or\r\n             and/or symptoms suggestive of COVID-19 or being contact subject within the past 14\r\n             days at enrolment visit.\r\n\r\n             (Ill or febrile participants may be re-scheduled within the trial inclusion period\r\n             when no longer presenting symptoms, except if condition is COVID19)\r\n\r\n          2. Participants with positive PCR, antigenic test or chest TDM or serology to SARS-CoV-2\r\n             at the enrolment visit, only for the group1.\r\n\r\n          3. Participants who already received another anti-SARS-CoV-2-vaccine\r\n\r\n          4. Participants who received BCG given within the last year.\r\n\r\n          5. Use of immunosuppressive drugs like e.g. corticosteroids at a dosage > 10mg equivalent\r\n             prednisone /day (excluding topical preparations and inhalers) within 3 months prior to\r\n             enrolment or 6 months for chemotherapies\r\n\r\n          6. Received immunoglobulin or other blood product within 3 months prior to enrolment or\r\n             planned receipt of immunoglobulin or a blood product through study completion.\r\n\r\n          7. Received any vaccination within 4 weeks prior to first injection or plan to receive a\r\n             licensed vaccine within 4 weeks after the last injection.\r\n\r\n          8. History of severe adverse reactions to vaccine administration, including anaphylaxis\r\n             and related symptoms, such as rash, respiratory difficulty, laryngeal oedema and\r\n             abdominal pain to vaccines, or history of allergic reaction likely to be exacerbated\r\n             by any component of the anti-SARS-CoV-2-vaccine.\r\n\r\n          9. History of severe allergic event\r\n\r\n         10. Known HIV, active HCV or HBV infection\r\n\r\n         11. Any pathological condition, such as cancer, which may be susceptible of reducing\r\n             immunity response\r\n\r\n         12. Any bleeding disorder considered as contraindication to intramuscular injection or\r\n             phlebotomy\r\n\r\n         13. The use of investigational Ig, investigational monoclonal antibodies or convalescent\r\n             serum are not allowed during the study\r\n\r\n         14. Any condition which in the opinion of the investigator may interfere with the aim of\r\n             the study\r\n\r\n         15. Pregnant or breastfeeding or positive pregnancy blood test at enrolment visit.\r\n\r\n         16. An immediate family member or household member of study staff.\r\n\r\n         17. Participation in another investigational clinical study (Jard 1 or Jard 2) within 4\r\n             weeks before the enrolment visit or still in an exclusion period from another clinical\r\n             trial or participation in another investigational clinical study planned before the\r\n             study completion.\r\n\r\n         18. People under legal protection measure (tutorship, curatorship or safeguard measures)\r\n      ","sponsor":"ANRS, Emerging Infectious Diseases","sponsor_type":"Other","conditions":"Healthy|Immunization; Infection","interventions":[{"intervention_type":"Biological","name":"Biological: two doses of BNT162b2 vaccine","description":"Administration of BNT162 b2 vaccine (30g in 0.3mL) at D1 and D29, intramuscularly (participants without antecedent of SARS-CoV-2 infection)"},{"intervention_type":"Biological","name":"Biological: one dose of BNT162b2 vaccine","description":"Administration of BNT162 b2 vaccine (30g in 0.3mL) at D1, intramuscularly (participants with antecedent of SARS-CoV-2 infection)"}],"outcomes":[{"outcome_type":"primary","measure":"IgG humoral response to vaccine 28 days post vaccination","time_frame":"at Day 57 for patients of the group1 and at Day 29 for patient of the group 2","description":"Anti SARS-CoV-2 Spike IgG (ELISA test) 28 days after the last injection i.e. at Day 57 in adult volunteers receiving 2 vaccine doses (group 1, without documented history of SARS-CoV-2 infection) and at Day 29 in adult volunteers receiving 1 vaccine dose (group 2, with documented history of SARS-CoV-2 infection)."},{"outcome_type":"secondary","measure":"humoral response to vaccine","time_frame":"Day 1, Day 29, Day 57, Month 6, Month 12, Month 24","description":"Anti SARS-CoV-2 specific IgG at Day 1, Day 29 (group 1), Day 57 (group 2), as measured via ELISA Anti SARS-CoV-2 IgA and IgM (total and subclasses IgG 1-4) as measured by ELISA at D 1, D29, D57, M6, M12 and M24 Specific neutralizing antibody to SARS-CoV-2 and its variants (classical in vitro neutralisation assay and Pseudo neutralisation assay ) (all participants)"},{"outcome_type":"secondary","measure":"T cells response to vaccine","time_frame":"at Day1, Day 57 and Month 6","description":"Fluorospot assays (TH1, TH2, TH17, Cytotoxicity) Phenotyping of antigen specific T-Cells via Mass cytometry at D 1 and M6 selected from results of Fluorospot assay"},{"outcome_type":"secondary","measure":"Mucosal response to vaccine","time_frame":"at Day 1, Day 29, Day 57, Month 6, Month 12 and Month 24","description":"Mucosal SARS-CoV-2 -specific antibody via measure of IgA, IgM and IgG in saliva by specific home-made and commercially available ELISA assays for salivary IgA and IgG (all participants)"},{"outcome_type":"secondary","measure":"B cell response to vaccine","time_frame":"at Day 1, Day 57 and Month 12","description":"Determination of the epitope profiling and B cell repertoire (stereotype clonotype) of the humoral response"},{"outcome_type":"secondary","measure":"predictive determinants of vaccine response","time_frame":"at screening visit","description":"Pre-existing serology for SARS-CoV-2 or other coronavirus, clinical profile of COVID 19 for group 2, immunosenescence profile, transcriptomic analysis, immune cell phenotype"},{"outcome_type":"secondary","measure":"Safety of BNT162b2 vaccine","time_frame":"through 28 days after each dose of vaccine for reactions; throughout the study period for others adverse events","description":"All grade adverse reactions:\r\nImmediate reactogenicity defined as any adverse reactions\r\nLocal and systemic reactogenicity, all grade, measured by solicited adverse reactions\r\nUnsolicited adverse reactions\r\nOthers adverse events:\r\nAny AEs of grade ≥ 2, .\r\nAEs leading to withdrawal .\r\nMedically significant AEs\r\nSAEs"},{"outcome_type":"secondary","measure":"SARS-CoV-2 infection","time_frame":"study period","description":"Occurrence of confirmed SARS-CoV-2 infection."}]}
{"nct_id":"NCT04611399","start_date":"2021-03-05","phase":"N/A","enrollment":90,"brief_title":"MIND-VR: Virtual Reality for COVID-19 Operators' Psychological Support","official_title":"MIND-VR: Virtual Reality for COVID-19 Operators' Psychological Support","primary_completion_date":"2022-03-05","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-03-05","last_update":"2021-03-19","description":"Since the COVID-19 pandemic began, several psychological support programs for health care workers have been implemented, especially group or individual counseling sessions delivered face-to-face or using phones and video conferencing platforms. However, there are significant barriers to the delivery of such psychological initiatives. In this context, digital interventions to improve health services and care outcomes are recommended for implementing and providing remote psychological support. Virtual reality can play a relevant role in providing psychological care to healthcare workers facing COVID-19. New commercial head-mounted display have made virtual reality accessible even to the mass audience, breaking down the barriers in the diffusion and use of this technology. Thanks to this fact, virtual reality can now be autonomously used by people and offered to provide psychological assistance remotely. Within this context, this randomized controlled study aims to investigate the efficacy of a virtual reality home-based program for diminishing stress and anxiety in a sample of Italian healthcare workers involved in the COVID-19 pandemic.","other_id":"MIND-VR/Besta","allocation":"Randomized","intervention_model":"Sequential Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","intervention_model_description":"The study can be defined as a controlled and randomized clinical trial, single-blind and monocentric, aimed at studying the efficacy of the intervention with virtual reality contents in the reduction of psychopathological symptoms of stress and anxiety in healthcare personnel involved in the care of COVID-19 patients. The study will be conducted according to the indications of Good Clinical Practices. The clinical efficacy of the intervention will be assessed at four different time distances (T0, T1, T2 and T3). The distance between the end of the intervention (T1) and the subsequent follow-up (T2) will be 3 months. A further follow-up (T3) will be carried out 3 months after T2.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age > 18, < 65;\r\n\r\n          -  Having worked on the front line as a doctor or nurse during the COVID-19 emergency\r\n             (i.e., having assisted COVID-19 patients or having worked in departments dedicated to\r\n             COVID-19 patients);\r\n\r\n          -  Normal or corrected to normal visual acuity;\r\n\r\n          -  Normal or corrected to normal hearing ability.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Physical illness: cardiovascular issues, neurological illness, epilepsy;\r\n\r\n          -  Pharmacotherapy with: psychotropic drugs, anti-hypertensive drugs, anti-epileptics;\r\n      ","sponsor":"Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta","sponsor_type":"Other","conditions":"Stress Related Disorder","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: VR for psychoeducation and relaxation","description":"Use of specifically developed VR contents to deliver psychoeducational content on stress and anxiety (i.e., \"MIND-VR\") and to train on relaxation techniques (i.e., \"The Secret Garden\")."},{"intervention_type":"Behavioral","name":"Behavioral: Text material for psychoeducation and audio for relaxation techniques","description":"Use of non-immersive contents to deliver psychoeducation on stress and anxiety (i.e., a PowerPoint presentation containing the same words and images in static form on a desktop of virtual psychoeducational content), and to train on relaxation techniques (i.e.,watching a video for relaxation)"}],"outcomes":[{"outcome_type":"primary","measure":"Change in score at the State-Trait Anxiety Inventory -Y2","time_frame":"Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up","description":"A 20 item measure of the level of the state anxiety"},{"outcome_type":"primary","measure":"Change in score at the Perceived Stress Scale","time_frame":"Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up","description":"A 10 item measure of the level of stress perceived in the last month"},{"outcome_type":"primary","measure":"Change in score at the Depression, Anxiety ans Stress Scale-21 items","time_frame":"Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up","description":"A 21 item in 3 self-report scales which measures depression, anxiety and stress"},{"outcome_type":"primary","measure":"Change in score of knowledge on stress and anxiety","time_frame":"Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up","description":"A 7 item measure at the ad hoc questionnaire to assess the knowledge of stress and anxiety"},{"outcome_type":"secondary","measure":"Change in score at the EQ-5D-5L","time_frame":"Baseline; immediately after the procedure/intervention; 3 months and 6 months follow-up","description":"A measure which defines the state of health and the perceived quality of life"}]}
{"nct_id":"NCT04629027","start_date":"2021-03-03","enrollment":80,"brief_title":"Evaluation System for the Efficacy of Immunologic Checkpoint Inhibitors in NSCLC","official_title":"Establishment of a Comprehensive Evaluation System for the Efficacy of Immunologic Checkpoint Inhibitors in the Treatment of Advanced Non-small Cell Lung Cancer","primary_completion_date":"2023-05-30","study_type":"Observational","rec_status":"Not yet recruiting","completion_date":"2023-05-30","last_update":"2021-02-24","description":"Inhibitors of programmed cell death protein 1 (PD-1) and programmed cell death ligand 1 (PD-L1) are effective therapies for metastatic NSCLC lacking sensitizing EGFR or ALK mutations. First-line combination regimens that include a PD-1 or PD-L1 inhibitor may maximize the chance of response and lead to prolonged survival. PD-L1 expression is the only validated predictive biomarker for selecting pembrolizumab treatment. However, it is far from being the ideal biomarker and its role in predicting efficacy from ICPIs remains undefined due to conflicting results from randomized clinical trials. The selection of patients most likely to benefit from immunotherapy is crucial in order to avoid exposure to potentially toxic and ineffective drugs as well as to prevent inappropriate allocation of health resources. Further studies are clearly needed to better understand the mechanism of action of immunotherapy in vivo thus allowing the identification of other predictive biomarkers. Therefore, our research team intends to explore advanced non-small cell lung cancer treated with immune checkpoint inhibitors, by combining the evaluation criteria of solid tumor efficacy evaluation criteria (RECIST1.1), clinical pathological characteristics of patients, and dynamic monitoring of peripheral blood molecular biological markers, finding the correlation with the efficacy of immunotherapy, establish a detection mode for selecting patients with clinical benefits.","other_id":"2020-2-2153","observational_model":"Case-Only","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"The patients can accepted immune checkpoint inhibitors.","criteria":"\n        Inclusion Criteria:\r\n\r\n        Ages 18 years of age. Histologically confirmed stage IIIB-IV non-squamous non-small cell\r\n        lung cancer. Life expectancy of at least 3 months.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Previous treatment . Untreated CNS metastases. Active autoimmune disease. Surgery or\r\n             significant traumatic injury. Active infection. History of allergy or hypersensitivity\r\n             to immunotherapy components. Women are breastfeeding or pregnant. Requiring systemic\r\n             treatment with either corticosteroids or other immunosuppressive medications.\r\n      ","sponsor":"Beijing Cancer Hospital","sponsor_type":"Other","conditions":"Non Small Cell Lung Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Immune checkpoint inhibitor","description":"the patients receive necessary treatment without special intervention"}],"outcomes":[{"outcome_type":"primary","measure":"circulating tumor cell","time_frame":"3 year","description":"The selection of patients most likely to benefit from immunotherapy is crucial in order to avoid exposure to potentially toxic and ineffective drugs."},{"outcome_type":"primary","measure":"T cell marker","time_frame":"3 year","description":"The selection of patients most likely to benefit from immunotherapy is crucial in order to avoid exposure to potentially toxic and ineffective drugs."}]}
{"nct_id":"NCT04670796","start_date":"2021-03-02","phase":"Phase 1","enrollment":111,"brief_title":"A Safety and Pharmacokinetic Study Between HLX02 and Herceptin(US-licensed and EU-approved) in Healthy Chinese Male Subjects","official_title":"A Phase I Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity Between HLX02 and Herceptin (US-licensed and EU-approved Reference Products, Double-blind, Randomized, Parallel-group Part) in Healthy Chinese Male Subjects","primary_completion_date":"2021-06-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-06-30","last_update":"2021-03-23","description":"Randomised, double-blind, parallel group Phase I study to compare PK profiles and to assess the safety and immunogenicity between HLX02 and Herceptin (U.S. and EU).","other_id":"HLX02-HV02","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Voluntarily signed Informed Consent Form\r\n\r\n          2. Healthy Chinese male (healthy is defined as the fact that no clinically significant\r\n             abnormalities are identified by medical history, physical examination, vital signs,\r\n             chest X ray, 12-lead ECG and laboratory tests)\r\n\r\n          3. Aged  18 and  45 years\r\n\r\n          4. Body mass index (BMI)  19 and  28 kg/m2\r\n\r\n          5. Body weight  50 and  80 kg\r\n\r\n          6. LVEF within normal range as examined through echocardiogram within 14 days prior to\r\n             randomization (>50%)\r\n\r\n          7. Immunogenicity (anti-drug [anti-trastuzumab] antibody [ADA]) tested as negative\r\n\r\n          8. Subject agrees that he and his female spouse/partner use reliable contraceptive\r\n             methods from the time of administration of study drug until 3 months after the end of\r\n             study, or subject is infertile\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Any clinically serious disease history or allergic disease, such as hematologic,\r\n             renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, mental and\r\n             nervous diseases and tumor\r\n\r\n          2. Use of monoclonal antibodies or any biological agent within 6 months prior to the\r\n             administration of the study drug\r\n\r\n          3. History of allergic reactions, including allergic reactions caused by any drug or\r\n             excipient in clinical study\r\n\r\n          4. Use of any prescription or non-prescription drug or dietary supplement within 5 half\r\n             lives of such drug or dietary supplement or 2 weeks prior to the administration of the\r\n             study drug (whichever is longer). The traditional Chinese medicine-based dietary\r\n             supplement should be discontinued 28 days prior to administration of the study drug\r\n\r\n          5. Donation of blood within 3 months prior to the administration of the study drug\r\n\r\n          6. Participation in other clinical studies within 3 months prior to the administration of\r\n             the study drug\r\n\r\n          7. Positive test result(s) for hepatitis B surface antigen (HBsAg), hepatitis C virus\r\n             (HCV) antibody, human immunodeficiency virus (HIV) antibody and treponema pallidum\r\n\r\n          8. History of drug abuse\r\n\r\n          9. Inability to follow the protocol requirements, instructions and study limitations as\r\n             judged by investigators, such as noncooperation, inability to return to the site for\r\n             follow-up visits or inability to complete the whole clinical study\r\n\r\n         10. Subject confirmed SARS-CoV-2 infection by appropriate test (including but not limited\r\n             to nucleic acid test) in screening period\r\n      ","sponsor":"Shanghai Henlius Biotech","sponsor_type":"Industry","conditions":"Healthy","interventions":[{"intervention_type":"Drug","name":"Drug: HLX02","description":"subject receive one dose of HLX02"},{"intervention_type":"Drug","name":"Drug: EU-sourced Trastuzumab (Herceptin)","description":"subject receive one dose of EU-sourced Trastuzumab (Herceptin)"},{"intervention_type":"Drug","name":"Drug: US-licensed Trastuzumab (Herceptin)","description":"subject receive one dose of US-licensed Trastuzumab (Herceptin)"}],"outcomes":[{"outcome_type":"primary","measure":"Area under the concentration-time curve from time zero to infinity (AUCinf)","time_frame":"57 days"},{"outcome_type":"secondary","measure":"Maximum serum concentration (Cmax)","time_frame":"57 days"},{"outcome_type":"secondary","measure":"time to Cmax (Tmax)","time_frame":"57 days"}]}
{"nct_id":"NCT04651218","start_date":"2021-03-02","phase":"Phase 3","enrollment":60,"brief_title":"Behavioral Mechanism of Energy Compensation With Exercise","official_title":"Food Reinforcement, Attentional Bias, and Inhibitory Control as Mechanisms of Energy Compensation With Exercise","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-01-31","last_update":"2021-09-14","description":"Over 70% of Americans are either overweight or obese, putting them at risk for many chronic diseases including diabetes. Exercise is commonly used as a weight loss and weight loss maintenance strategy. However, exercise-induced weight loss is often much less than expected as individuals compensate for a large portion of the energy expended through exercise, resisting maintenance of the negative energy balance needed for weight loss. Our prior research, in agreement with others, point to increases in energy intake as the primary compensatory response when exercising for weight loss; however, mechanisms promoting this behavior have yet to be fully elucidated. With obesity and diabetes prevalence continually rising, innovative research is needed to identify novel mechanisms promoting energy compensation with exercise. The long-term goal of this proposal is to reduce the incidence and improve the outcomes of obesity-related diseases by developing interventions that will attenuate compensation for the energy expended through exercise and thus improve initial weight loss and weight loss maintenance. The present proposal will take the necessary first steps towards our long-term goal by identifying novel mechanisms promoting energy intake when exercising for weight loss. One's reinforcing value of food, attentional bias and inhibitory control for food cues play an important role in feeding behaviors, independent of hunger. These behaviors are largely a product of the central dopamine reward system, which is also in play with exercise behavior. This provides mechanistic support for our central hypothesis, that exercise evokes increases in food reinforcement, attentional bias, and lowers inhibitory control for food cues to promote greater energy intake in effort to maintain energy homeostasis. The rationale for this project is by elucidating the mechanisms mediating energy compensation, future interventions can be designed that attenuate this response to improve the utility of exercise as a weight loss intervention to prevent and manage T2DM. The overall objective of the current proposal is to demonstrate an acute bout of exercise alters food reinforcement, attentional bias and inhibitory control for food cues. Upon completion, we will have a greater understanding of the mechanisms underpinning compensatory increases in energy intake when exercising. These findings will pave the way for future clinical trials testing this hypothesis in the context of a long-term exercise intervention. This contribution is significant, as the identification of novel mechanisms influencing energy compensation with exercise is needed to provide strong support for the development of novel, evidence-based interventions to attenuate this compensatory response to exercise, improving its efficacy for weight control and chronic disease management.","other_id":"52127","allocation":"Non-Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Single","intervention_model_description":"counter balanced crossover design, exercise group and control treatment.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  overweight to obese (BMI 25-45 kg/m2)\r\n\r\n          -  not currently engaged in exercise or weight loss activities\r\n\r\n          -  free of any cardiac, pulmonary, or metabolic health conditions\r\n\r\n          -  able to safely engage in exercise\r\n\r\n          -  female participants must be premenopausal and not pregnant or nursing.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Lost or gained over 5% of their current bodyweight in the previous 12 months.\r\n\r\n          -  taking any medications or dietary supplements which may influence energy expenditure\r\n             or intake\r\n\r\n          -  have not been diagnosed with an eating disorder, clinical depression, or an anxiety\r\n             disorder\r\n\r\n          -  engage in less than 150 minutes of moderate to vigorous physical activity per week\r\n             (assessed via accelerometry at baseline)\r\n      ","sponsor":"Kyle Flack","sponsor_type":"Other","conditions":"Obesity|Weight Loss|Eating Behavior","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: exericse","description":"participants perform aerobic exercise until they expend 500 kcal"}],"outcomes":[{"outcome_type":"primary","measure":"attentional bias","time_frame":"Immediately prior to exercise bout","description":"The visual probe procedure involves eye-tracking technology that records the amount of time (ms) participants spend fixated on images projected on a computer screen [80-82]. Critical task stimuli (20 images of various foods) are matched with 10 neutral images (non- food-related) on a computer screen. These images will be presented for 1,000 ms and a visual probe will then appear on either side of the screen in place of one of the previously presented images. Participants will respond as quickly as possible to indicate which side the probe appears by pressing a corresponding computer key. Mean fixation time (amount of time looking at each image) and visual probe response time (amount of time taken to respond to the probe) will be recorded in ms."},{"outcome_type":"primary","measure":"attentional bias","time_frame":"Immediately prior to bout of television watching","description":"The visual probe procedure involves eye-tracking technology that records the amount of time (ms) participants spend fixated on images projected on a computer screen [80-82]. Critical task stimuli (20 images of various foods) are matched with 10 neutral images (non- food-related) on a computer screen. These images will be presented for 1,000 ms and a visual probe will then appear on either side of the screen in place of one of the previously presented images. Participants will respond as quickly as possible to indicate which side the probe appears by pressing a corresponding computer key. Mean fixation time (amount of time looking at each image) and visual probe response time (amount of time taken to respond to the probe) will be recorded in ms."},{"outcome_type":"primary","measure":"attentional bias","time_frame":"15 minutes after the bout of television watching","description":"The visual probe procedure involves eye-tracking technology that records the amount of time (ms) participants spend fixated on images projected on a computer screen [80-82]. Critical task stimuli (20 images of various foods) are matched with 10 neutral images (non- food-related) on a computer screen. These images will be presented for 1,000 ms and a visual probe will then appear on either side of the screen in place of one of the previously presented images. Participants will respond as quickly as possible to indicate which side the probe appears by pressing a corresponding computer key. Mean fixation time (amount of time looking at each image) and visual probe response time (amount of time taken to respond to the probe) will be recorded in ms."},{"outcome_type":"primary","measure":"attentional bias","time_frame":"15 minutes after the exercise bout","description":"The visual probe procedure involves eye-tracking technology that records the amount of time (ms) participants spend fixated on images projected on a computer screen [80-82]. Critical task stimuli (20 images of various foods) are matched with 10 neutral images (non- food-related) on a computer screen. These images will be presented for 1,000 ms and a visual probe will then appear on either side of the screen in place of one of the previously presented images. Participants will respond as quickly as possible to indicate which side the probe appears by pressing a corresponding computer key. Mean fixation time (amount of time looking at each image) and visual probe response time (amount of time taken to respond to the probe) will be recorded in ms."},{"outcome_type":"primary","measure":"inhibitory control","time_frame":"Immediately prior to exercise bout","description":"Participants are required to respond to food-related images or neutral (non-food) images. Food-related images will include a mix of high and low-energy density foods and further separated into high carbohydrate, high fat, and high protein foods. Neutral images will be if those not associated with eating such as office supplies or other accessories. After the cue image is presented, it will either turn solid green (go) or blue (no-go). Participants respond by pressing the appropriate keyboard button when the green target appears and withhold responding when the blue target appears. Failing to withhold responding (blue) to a food-related image is indicative of poor inhibitory control for food cues."},{"outcome_type":"primary","measure":"inhibitory control","time_frame":"Immediately prior to bout of television watching","description":"Participants are required to respond to food-related images or neutral (non-food) images. Food-related images will include a mix of high and low-energy density foods and further separated into high carbohydrate, high fat, and high protein foods. Neutral images will be if those not associated with eating such as office supplies or other accessories. After the cue image is presented, it will either turn solid green (go) or blue (no-go). Participants respond by pressing the appropriate keyboard button when the green target appears and withhold responding when the blue target appears. Failing to withhold responding (blue) to a food-related image is indicative of poor inhibitory control for food cues."},{"outcome_type":"primary","measure":"inhibitory control","time_frame":"15 minutes after the exercise bout","description":"Participants are required to respond to food-related images or neutral (non-food) images. Food-related images will include a mix of high and low-energy density foods and further separated into high carbohydrate, high fat, and high protein foods. Neutral images will be if those not associated with eating such as office supplies or other accessories. After the cue image is presented, it will either turn solid green (go) or blue (no-go). Participants respond by pressing the appropriate keyboard button when the green target appears and withhold responding when the blue target appears. Failing to withhold responding (blue) to a food-related image is indicative of poor inhibitory control for food cues."},{"outcome_type":"primary","measure":"inhibitory control","time_frame":"15 minutes after the bout of television watching","description":"Participants are required to respond to food-related images or neutral (non-food) images. Food-related images will include a mix of high and low-energy density foods and further separated into high carbohydrate, high fat, and high protein foods. Neutral images will be if those not associated with eating such as office supplies or other accessories. After the cue image is presented, it will either turn solid green (go) or blue (no-go). Participants respond by pressing the appropriate keyboard button when the green target appears and withhold responding when the blue target appears. Failing to withhold responding (blue) to a food-related image is indicative of poor inhibitory control for food cues."},{"outcome_type":"primary","measure":"food reinforcement","time_frame":"Immediately prior to exercise bout","description":"Becker-deGroot-Marshak Auction Task (BDM). The BDM measures willingness to pay (WTP) for an item \"on auction\". Participants are provided with a sum of money (e.g. $5) and view pictures of familiar food items and are told that they must bid against the computer to win the food. Following the completion\r\nof the task they are informed one of the trials is selected at random and if they won that trial then they will be provided with the food. If not, they must wait a period of time in the hungry state (e.g. 30 min) before they can leave the laboratory. Since, the amount of money is finite, the optimum strategy is to bid according to how much the food is valued"},{"outcome_type":"primary","measure":"food reinforcement","time_frame":"Immediately prior to bout of television watching","description":"Becker-deGroot-Marshak Auction Task (BDM). The BDM measures willingness to pay (WTP) for an item \"on auction\". Participants are provided with a sum of money (e.g. $5) and view pictures of familiar food items and are told that they must bid against the computer to win the food. Following the completion\r\nof the task they are informed one of the trials is selected at random and if they won that trial then they will be provided with the food. If not, they must wait a period of time in the hungry state (e.g. 30 min) before they can leave the laboratory. Since, the amount of money is finite, the optimum strategy is to bid according to how much the food is valued"},{"outcome_type":"primary","measure":"food reinforcement","time_frame":"15 minutes after the exercise bout","description":"Becker-deGroot-Marshak Auction Task (BDM). The BDM measures willingness to pay (WTP) for an item \"on auction\". Participants are provided with a sum of money (e.g. $5) and view pictures of familiar food items and are told that they must bid against the computer to win the food. Following the completion\r\nof the task they are informed one of the trials is selected at random and if they won that trial then they will be provided with the food. If not, they must wait a period of time in the hungry state (e.g. 30 min) before they can leave the laboratory. Since, the amount of money is finite, the optimum strategy is to bid according to how much the food is valued"},{"outcome_type":"primary","measure":"food reinforcement","time_frame":"15 minutes after the bout of television watching","description":"Becker-deGroot-Marshak Auction Task (BDM). The BDM measures willingness to pay (WTP) for an item \"on auction\". Participants are provided with a sum of money (e.g. $5) and view pictures of familiar food items and are told that they must bid against the computer to win the food. Following the completion\r\nof the task they are informed one of the trials is selected at random and if they won that trial then they will be provided with the food. If not, they must wait a period of time in the hungry state (e.g. 30 min) before they can leave the laboratory. Since, the amount of money is finite, the optimum strategy is to bid according to how much the food is valued"}]}
{"nct_id":"NCT04839484","start_date":"2021-03-02","phase":"N/A","enrollment":118,"brief_title":"LifeSprout Lumina Study in the Treatment of Nasolabial Folds","official_title":"A Prospective, Randomized, Controlled, Multi-center Study of the Safety and Effectiveness of Lumina in the Treatment of Nasolabial Folds","primary_completion_date":"2021-11-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-06-30","last_update":"2021-04-09","description":"The study will be a prospective, randomized, split-face, double blind, controlled, clinical trial to evaluate the safety and effectiveness of Lumina for the treatment of Nasolabial Folds (NLFs). Subjects will be randomized to receive treatment (Lumina) in one NLF and control (Restylane Defyne) in the contra-lateral NLF. 118 subjects will be treated.","other_id":"CT001","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"Single","intervention_model_description":"Parallel assignment to product to different sides of face, per randomization code. At 12 months subjects may be retreated only with study product (partial cross over potential)","sampling_method":"","gender":"All","minimum_age":22,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Subject aged at least 22 years.\r\n\r\n          2. Subject has bilateral moderate or severe (grade 3 or 4) NLFs on the WSRS as scored by\r\n             a live, masked evaluator.\r\n\r\n          3. Subject willing to abstain from other facial aesthetic procedures in the NLFs through\r\n             the 12 month (13 month if retreatment at 12 months) follow-up visit which could\r\n             interfere with treatment outcomes (e.g. facial fillers, skin laser and radiofrequency\r\n             therapy such as Thermage, chemical re-surfacing, dermabrasion, Botox injections,\r\n             aesthetic facial surgery, other facial treatments in the NLFs.\r\n\r\n          4. Subject understands and accepts the obligation to present for all scheduled follow-up\r\n             visits and is logistically able to meet all study requirements.\r\n\r\n          5. Subject with facial hair which may obstruct the assessment of the treatment area, must\r\n             be agreeable with non-laser removal of facial hair prior to assessment visits.\r\n\r\n          6. Subject willing to provide written informed consent for their participation in the\r\n             study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Subject is a female of childbearing potential (e.g., not postmenopausal for at least\r\n             one year or has not had a hysterectomy or tubal ligation) not using medically\r\n             effective birth control (e.g., hormonal methods in use at least 30 days prior to\r\n             injection or barrier methods such as condom and spermicide in use at least 14 days\r\n             prior to injection) or is pregnant, lactating, or plans to become pregnant during the\r\n             study.\r\n\r\n          2. Subject has participated in a clinical study in which an investigational device or\r\n             drug was received in the 30 days prior to screening or plans to enroll in such a study\r\n             during the course of the current study.\r\n\r\n          3. Subject is an employee or direct relative of an employee of the investigational site\r\n             or study sponsor.\r\n\r\n          4. Subject who has received surgery in the NLFs.\r\n\r\n          5. Subject has a serious or progressive disease, which, in the investigator's judgment,\r\n             puts the subject at undue risk (e.g. uncontrolled diabetes, autoimmune disease,\r\n             cardiac pathologies).\r\n\r\n          6. Subject has an acute inflammatory process or infection, or history of chronic or\r\n             recurrent infection or inflammation with the potential to interfere with the study\r\n             results or increase the risk of adverse events.\r\n\r\n          7. Subject has a disorder that may impact wound healing such as connective tissue or\r\n             immunosuppressive disorder.\r\n\r\n          8. Subject has a history of precancerous lesions/skin malignancies.\r\n\r\n          9. Subject has had an active skin disease within the past 6 months.\r\n\r\n         10. Subject has scars, infection, rosacea, herpes, acne, blotches or other pathology in\r\n             the NLFs.\r\n\r\n         11. Subject has facial hair covering the nasolabial folds that they are unwilling to\r\n             remove for study assessments.\r\n\r\n         12. Subject has a past history of streptococcal disease or an active streptococcus\r\n             infection.\r\n\r\n         13. Subject has a past history of allergy or hypersensitivity to gram positive bacterial\r\n             proteins.\r\n\r\n         14. Subject is predisposed to keloidosis or hypertrophic scarring.\r\n\r\n         15. Subject has a known history of hyper- or hypo-pigmentation in the NLFs.\r\n\r\n         16. Subject with known allergy to poly (-caprolactone) microfibers, phosphate buffered\r\n             saline, polyethylene glycol dithiol (PEG-SH), sodium-hyaluronate of bacterial origin,\r\n             hyaluronic acid or streptococcal protein.\r\n\r\n         17. Subject has a known history of multiple allergies, allergic/anaphylactic reactions\r\n             including hypersensitivity to lidocaine or anesthetics of the amide type.\r\n\r\n         18. Subject has a known bleeding disorder.\r\n\r\n         19. Subject has received within the past week or plans to receive up to 1 month after\r\n             treatment high-dose Vitamin E, aspirin, anti-inflammatories, antiplatelets,\r\n             thrombolytics or any other medication that could increase the risk of bleeding.\r\n\r\n         20. Subject has received any medication which, in the judgement of the investigator, may\r\n             interfere with the study objectives.\r\n\r\n         21. Subject has received within the past 12 months or plans to receive during the study\r\n             any injections outside of those in the study protocol including non-permanent fillers\r\n             (e.g., hyaluronic acid, CaHA) or neurotoxin on the face below the orbital rim\r\n             (forehead is acceptable).\r\n\r\n         22. Subject has received at any time or plans to receive during the study a permanent\r\n             filler (e.g., polylactic acid, PMMA, silicone) on the face.\r\n\r\n         23. Subject has received within the past 2 weeks or plans to receive during the study\r\n             dermal resurfacing procedures or non-invasive skin tightening on the face.\r\n\r\n         24. Subject has received in the past 2 weeks or plans to receive during the study\r\n             prescription facial wrinkle therapies (RENOVA), topical steroids, skin irritating\r\n             topical preparations, or self-tanning agents on the face.\r\n\r\n         25. Subject has a known history of rapid weight loss/gain or plans to begin a weight loss\r\n             program during the study (5% of body weight).\r\n      ","sponsor":"LifeSprout, Inc.","sponsor_type":"Industry","conditions":"Nasolabial Fold","interventions":[{"intervention_type":"Device","name":"Device: Study Product","description":"up to 2cc per injection of filler placed into nasolabial fold."},{"intervention_type":"Device","name":"Device: Active Control","description":"up to 2cc per injection of filler placed into nasolabial fold."}],"outcomes":[{"outcome_type":"secondary","measure":"Proportion WSRS photographic","time_frame":"6 weeks, 3, 6, 9, and 12 months","description":"proportion of NLFs in the Lumina™ treatment arm compared to that of NLFs in the Restylane® Defyne control arm with ≥1 point improvement from baseline on the WSRS, as determined by a photographic reviewer"},{"outcome_type":"primary","measure":"primary effectiveness Wrinkle Severity Rating Scale (WSRS)","time_frame":"6 month","description":"The mean change from baseline of NLFs in the Lumina™ treatment arm will be compared to that of NLFs in the Restylane® Defyne control arm. (5 point scale with 1 being no visible NLF and 5 being extreme, deep and long NLFs)"},{"outcome_type":"secondary","measure":"WSRS other timepoint","time_frame":"6 weeks, 3, 9, and 12 months","description":"Individual endpoints at each timepoint of other than 6 month for mean change from baseline on the WSRS scale, as determined by the live, masked evaluator"},{"outcome_type":"secondary","measure":"WSRS proportions","time_frame":"6 weeks, 3, 6, 9, and 12 months","description":"proportion of NLFs in the Lumina™ treatment arm compared to that of NLFs in the Restylane® Defyne control arm with ≥1 point improvement from baseline on the WSRS"},{"outcome_type":"secondary","measure":"Global Aesthetics Improvement Scale (GAIS) - Masked Evaluator","time_frame":"6 weeks, 3, 6, 9, and 12 months","description":"Individual endpoints for each rater type, as rated by the live, masked evaluator (5 point scale with 1 being most improvement and 5 being worsened)"},{"outcome_type":"secondary","measure":"GAIS Subject","time_frame":"6 weeks, 3, 6, 9, and 12 months","description":"Individual endpoints for each rater type, as rated by the study subject."},{"outcome_type":"secondary","measure":"GAIS Investigator","time_frame":"6 weeks, 3, 6, 9, and 12 months","description":"Individual endpoints for each rater type, as rated by treating investigator"},{"outcome_type":"secondary","measure":"FACE-Q (standardized questionnaire developed by Memorial Sloan Kettering) Appraisal of Nasolabial Folds Questionnaire","time_frame":"6 weeks, 3, 6, 9, and 12 months","description":"change from baseline for Lumina™ and Restylane® Defyne on the Subject FACE-Q Appraisal of Nasolabial Folds Questionnaire"},{"outcome_type":"secondary","measure":"Visual Analog Scale (VAS) Pain","time_frame":"injection","description":"pain assessment in NLFs treated with Lumina™ compared to NLFs treated with Restylane® Defyne at initial injection"},{"outcome_type":"secondary","measure":"WSRS Photographics","time_frame":"6 weeks, 3, 6, 9, and 12 months","description":"Individual endpoints at each timepoint of 6 weeks, 3, 6, 9, and 12 months for mean change from baseline on the WSRS scale for NLFs treated with Lumina™ compared to NLFs treated with Restylane® Defyne, as rated by a photographic reviewer."},{"outcome_type":"other","measure":"Safety Endpoint","time_frame":"13 month","description":"to assess the rate and severity of adverse events from initial treatment through last study visit."}]}
{"nct_id":"NCT04740931","start_date":"2021-03-02","phase":"Phase 3","enrollment":750,"brief_title":"A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion","official_title":"A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion","primary_completion_date":"2023-02-16","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2024-01-18","last_update":"2021-09-13","description":"This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled, parallel-group study evaluating the efficacy, safety, and pharmacokinetics of faricimab administered by intravitreal (IVT) injection at 4-week intervals until Week 24, followed by a double-masked period of study without active control to evaluate faricimab administered according to a personalized treatment interval (PTI) dosing regimen in patients with macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO).","other_id":"GR41986","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Foveal center-involved macular edema due to central retinal vein occlusion (CRVO) or\r\n             hemiretinal vein occlusion (HRVO), diagnosed no longer than 4 months prior to the\r\n             screening visit\r\n\r\n          -  Best-corrected visual acuity (BCVA) of 73 to 19 letters, inclusive (20/40 to 20/400\r\n             approximate Snellen equivalent)\r\n\r\n          -  Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition\r\n             of good quality retinal images to confirm diagnosis\r\n\r\n          -  For women of childbearing potential: agreement to remain abstinent or use\r\n             contraception, and agreement to refrain from donating eggs during the treatment period\r\n             and for 3 months after the final dose of study treatment\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any major illness or major surgical procedure within 1 month before screening\r\n\r\n          -  Uncontrolled blood pressure\r\n\r\n          -  Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to\r\n             Day 1\r\n\r\n          -  Pregnant or breastfeeding, or intending to become pregnant during the study\r\n\r\n        Ocular Exclusion Criteria for Study Eye:\r\n\r\n          -  History of previous episodes of macular edema due to RVO or persistent macular edema\r\n             due to RVO diagnosed more than 4 months before screening\r\n\r\n          -  Any current ocular condition which, in the opinion of the investigator, is currently\r\n             causing or could be expected to contribute to irreversible vision loss due to a cause\r\n             other than macular edema due to RVO in the study eye (e.g., ischemic maculopathy,\r\n             Irvine-Gass syndrome, foveal atrophy, foveal fibrosis, pigment abnormalities, dense\r\n             subfoveal hard exudates, or other non-retinal conditions)\r\n\r\n          -  Macular laser (focal/grid) in the study eye at any time prior to Day 1\r\n\r\n          -  Panretinal photocoagulation in the study eye within 3 months prior to Day 1 or\r\n             anticipated within 3 months of study start on Day 1\r\n\r\n          -  Any prior or current treatment for macular edema; macular neovascularization,\r\n             including diabetic macular edema (DME) and neovascular age-related macular\r\n             degeneration (nAMD); and vitreomacular-interface abnormalities, including, but not\r\n             restricted to, IVT treatment with anti-VEGF, steroids, tissue plasminogen activator,\r\n             ocriplasmin, C3F8, air or periocular injection\r\n\r\n          -  Any prior intervention with verteporfin photodynamic therapy, diode laser,\r\n             transpupillary thermotherapy, or vitreo-retinal surgery including sheatotomy\r\n\r\n          -  Any prior steroid implant use including dexamethasone intravitreal implant (Ozurdex)\r\n             and fluocinolone acetonide intravitreal implant (Iluvien)\r\n\r\n        Ocular Exclusion Criteria for Both Eyes:\r\n\r\n          -  Prior IVT administration of faricimab in either eye\r\n\r\n          -  History of idiopathic or autoimmune-associated uveitis in either eye\r\n\r\n          -  Active periocular, ocular or intraocular inflammation or infection (including\r\n             suspected) in either eye on Day 1\r\n      ","sponsor":"Hoffmann-La Roche","sponsor_type":"Industry","conditions":"Macular Edema|Central Retinal Vein Occlusion|Hemiretinal Vein Occlusion","interventions":[{"intervention_type":"Drug","name":"Drug: Faricimab","description":"Faricimab will be administered by intravitreal (IVT) injection as specified in each treatment arm."},{"intervention_type":"Drug","name":"Drug: Aflibercept","description":"Aflibercept 2 mg will be administered by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections)."},{"intervention_type":"Procedure","name":"Procedure: Sham Procedure","description":"The sham is a procedure that mimics an IVT injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking."}],"outcomes":[{"outcome_type":"secondary","measure":"Part 1: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA from Baseline at Specified Timepoints Through Week 24","time_frame":"Baseline, Weeks 4, 8, 12, 16, 20, and 24"},{"outcome_type":"secondary","measure":"Part 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72","time_frame":"Baseline and every 4 weeks from Week 24 to Week 72"},{"outcome_type":"primary","measure":"Change from Baseline in Best-Corrected Visual Acuity (BCVA) at Week 24","time_frame":"Baseline and Week 24"},{"outcome_type":"secondary","measure":"Part 1: Change from Baseline in BCVA at Specified Timepoints Through Week 24","time_frame":"Baseline, Weeks 4, 8, 12, 16, 20, and 24"},{"outcome_type":"secondary","measure":"Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline at Week 24","time_frame":"Baseline and Week 24"},{"outcome_type":"secondary","measure":"Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline at Specified Timepoints Through Week 24","time_frame":"Baseline, Weeks 4, 8, 12, 16, 20, and 24"},{"outcome_type":"secondary","measure":"Part 1: Percentage of Participants Gaining ≥10 Letters in BCVA from Baseline at Specified Timepoints Through Week 24","time_frame":"Baseline, Weeks 4, 8, 12, 16, 20, and 24"},{"outcome_type":"secondary","measure":"Part 1: Percentage of Participants Gaining ≥5 Letters in BCVA from Baseline at Specified Timepoints Through Week 24","time_frame":"Baseline, Weeks 4, 8, 12, 16, 20, and 24"},{"outcome_type":"secondary","measure":"Part 1: Percentage of Participants Gaining >0 Letters in BCVA from Baseline at Specified Timepoints Through Week 24","time_frame":"Baseline, Weeks 4, 8, 12, 16, 20, and 24"},{"outcome_type":"secondary","measure":"Part 1: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline at Specified Timepoints Through Week 24","time_frame":"Baseline, Weeks 4, 8, 12, 16, 20, and 24"},{"outcome_type":"secondary","measure":"Part 1: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA from Baseline at Specified Timepoints Through Week 24","time_frame":"Baseline, Weeks 4, 8, 12, 16, 20, and 24"},{"outcome_type":"secondary","measure":"Part 1: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA from Baseline at Specified Timepoints Through Week 24","time_frame":"Baseline, Weeks 4, 8, 12, 16, 20, and 24"},{"outcome_type":"secondary","measure":"Part 1: Percentage of Participants Achieving ≥84 Letters (20/20 Snellen Equivalent) in BCVA at Specified Timepoints Through Week 24","time_frame":"Baseline, Weeks 4, 8, 12, 16, 20, and 24"},{"outcome_type":"secondary","measure":"Part 1: Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better at Specified Timepoints Through Week 24","time_frame":"Baseline, Weeks 4, 8, 12, 16, 20, and 24"},{"outcome_type":"secondary","measure":"Part 1: Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse at Specified Timepoints Through Week 24","time_frame":"Baseline, Weeks 4, 8, 12, 16, 20, and 24"},{"outcome_type":"secondary","measure":"Part 1: Change from Baseline in Central Subfield Thickness at Specified Timepoints Through Week 24","time_frame":"Baseline, Weeks 4, 8, 12, 16, 20, and 24"},{"outcome_type":"secondary","measure":"Part 1: Change from Baseline in National Eye Institute 25-Item Visual Functioning Questionnaire (NEI VFQ-25) Composite Score at Specified Timepoints Through Week 24","time_frame":"Baseline, Weeks 4, 8, 12, 16, 20, and 24"},{"outcome_type":"secondary","measure":"Part 2: Change from Baseline in BCVA at Specified Timepoints from Week 24 Through Week 72","time_frame":"Baseline and every 4 weeks from Week 24 to Week 72"},{"outcome_type":"secondary","measure":"Part 2: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline at Week 72","time_frame":"Baseline and Week 72"},{"outcome_type":"secondary","measure":"Part 2: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72","time_frame":"Baseline and every 4 weeks from Week 24 to Week 72"},{"outcome_type":"secondary","measure":"Part 2: Percentage of Participants Gaining ≥10 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72","time_frame":"Baseline and every 4 weeks from Week 24 to Week 72"},{"outcome_type":"secondary","measure":"Part 2: Percentage of Participants Gaining ≥5 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72","time_frame":"Baseline and every 4 weeks from Week 24 to Week 72"},{"outcome_type":"secondary","measure":"Part 2: Percentage of Participants Gaining >0 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72","time_frame":"Baseline and every 4 weeks from Week 24 to Week 72"},{"outcome_type":"secondary","measure":"Part 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72","time_frame":"Baseline and every 4 weeks from Week 24 to Week 72"},{"outcome_type":"secondary","measure":"Part 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72","time_frame":"Baseline and every 4 weeks from Week 24 to Week 72"},{"outcome_type":"secondary","measure":"Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72","time_frame":"Baseline and every 4 weeks from Week 24 to Week 72"},{"outcome_type":"secondary","measure":"Part 2: Percentage of Participants Achieving ≥84 Letters (20/20 Snellen Equivalent) in BCVA at Specified Timepoints from Week 24 Through Week 72","time_frame":"Every 4 weeks from Week 24 to Week 72"},{"outcome_type":"secondary","measure":"Part 2: Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better at Specified Timepoints from Week 24 Through Week 72","time_frame":"Every 4 weeks from Week 24 to Week 72"},{"outcome_type":"secondary","measure":"Part 2: Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse at Specified Timepoints from Week 24 Through Week 72","time_frame":"Every 4 weeks from Week 24 to Week 72"},{"outcome_type":"secondary","measure":"Part 2: Change from Week 24 in BCVA at Specified Timepoints Through Week 72","time_frame":"Every 4 weeks from Week 24 to Week 72"},{"outcome_type":"secondary","measure":"Part 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Week 24 at Specified Timepoints Through Week 72","time_frame":"Every 4 weeks from Week 24 to Week 72"},{"outcome_type":"secondary","measure":"Part 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA from Week 24 at Specified Timepoints Through Week 72","time_frame":"Every 4 weeks from Week 24 to Week 72"},{"outcome_type":"secondary","measure":"Part 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA from Week 24 at Specified Timepoints Through Week 72","time_frame":"Every 4 weeks from Week 24 to Week 72"},{"outcome_type":"secondary","measure":"Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA from Week 24 at Specified Timepoints Through Week 72","time_frame":"Every 4 weeks from Week 24 to Week 72"},{"outcome_type":"secondary","measure":"Part 2: Percentage of Participants on Different Treatment Intervals at Week 72","time_frame":"Week 72"},{"outcome_type":"secondary","measure":"Part 2: Number of Study Drug Injections Received from Week 24 Through Week 72","time_frame":"From Week 24 to Week 72"},{"outcome_type":"secondary","measure":"Part 2: Change from Baseline in Central Subfield Thickness at Specified Timepoints from Week 24 Through Week 72","time_frame":"Baseline and every 4 weeks from Week 24 to Week 72"},{"outcome_type":"secondary","measure":"Part 2: Change from Baseline in NEI VFQ-25 Questionnaire Composite Score at Specified Timepoints from Week 24 Through Week 72","time_frame":"Baseline and every 4 weeks from Week 24 to Week 72"},{"outcome_type":"secondary","measure":"Incidence and Severity of Ocular Adverse Events, with Severity Determined According to Adverse Event Severity Grading Scale","time_frame":"From Baseline until end of study (up to 72 weeks)"},{"outcome_type":"secondary","measure":"Incidence and Severity of Non-Ocular Adverse Events, with Severity Determined According to Adverse Event Severity Grading Scale","time_frame":"From Baseline until end of study (up to 72 weeks)"},{"outcome_type":"secondary","measure":"Plasma Concentration of Faricimab Over Time","time_frame":"Predose at Day 1, Weeks 4, 24, 28, 52, and 72"},{"outcome_type":"secondary","measure":"Number of Participants with Anti-Drug Antibodies (ADAs) to Faricimab at Baseline and During the Study","time_frame":"Predose at Day 1 (Baseline), Weeks 4, 24, 28, 52, and 72"}]}
{"nct_id":"NCT04379206","start_date":"2021-03-01","enrollment":400,"brief_title":"Social Network Approach for Increasing Testing Coverage Among Men Who Have Sex With Men","official_title":"Social Network Approach for Increasing Testing Coverage Among Men Who Have Sex With Men","primary_completion_date":"2021-05-12","study_type":"Observational","rec_status":"Completed","completion_date":"2021-05-12","last_update":"2021-07-28","description":"HIV testing is essential in shortening the time to identify a new infection, the first 90 of the UNAIDS 90-90-90 targets. However, over one-third of the men who have sex with men (MSM) had never been tested for HIV; even if they did, one-fifth had their tests done more than a year ago. Assortative mixing pattern observed in the HIV-positive MSM group shaped the transmission dynamics and could be leveraged for intervention. Barriers to access HIV testing services could, on the other hand, be hurdled by self-tests. A network approach for intervention could therefore be promising in delivering effective HIV self-tests. To experiment with such an approach, a 2-phase study was conceptualised incorporating actual network-based referred HIV self-tests and an agent-based simulation evaluating its impact. Sixty-four MSM would be recruited as seeds for promoting HIV self-tests within their network and those being referred could refer their friends for the same after passing online training. To facilitate the process, an online platform would be developed offering information, collecting informed consent, requesting HIV self-test kits, returning results, performing online training, and referring peers. Participants could opt to receive self-tests by delivery or to conduct it on-site with staff assistance. A hotline with video conferencing support would be maintained to assist those who self-test at home. They could also choose between blood and oral fluid tests. Primary outcomes to measure are number and proportion of MSM who had never or not tested within 12 months, and the associating factors. Data collected in the empirical study would be used for parameterising the agent-based simulation to evaluate the impact of the approach in increasing testing coverage and shortening time to diagnosis. Its economic assessment would also be performed to cost each new infection to be identified. The approach could be feasible and effective to be adopted for future broader implementation for peer-led HIV self-test kit or HIV prevention message distribution.","other_id":"MSS324R","observational_model":"Cohort","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"Male","minimum_age":18,"population":"Adult men who have sex with men in Hong Kong","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  male\r\n\r\n          -  had sex with another male in the preceding year\r\n\r\n          -  able to communicate in written Chinese or English\r\n\r\n          -  normally resided in Hong Kong\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  known HIV-positive\r\n\r\n          -  prisoners\r\n\r\n          -  having mental illnesses that informed consent cannot be obtained\r\n      ","sponsor":"Chinese University of Hong Kong","sponsor_type":"Other","conditions":"HIV Infections","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: HIV self-test kit","description":"fingerprick and oral fluid HIV self-tests with optional on-site or hotline staff assistance"}],"outcomes":[{"outcome_type":"primary","measure":"effectiveness of the approach in reaching MSM who have never or not recently tested for HIV","time_frame":"Through study completion, at year 2","description":"proportion of testers who have never or not recently tested for HIV"},{"outcome_type":"secondary","measure":"Determinants of key actors in the social network","time_frame":"Through study completion, at year 2","description":"Network metrics predicting important actors in the referral network"},{"outcome_type":"secondary","measure":"Preference of two forms of HIV self-testing","time_frame":"Through study completion, at year 2","description":"Proportion of testers favouring each form of self-testing"},{"outcome_type":"secondary","measure":"Effect of network-based HIV self-test promotion in controlling transmission among MSM","time_frame":"Through study completion, at year 2","description":"Number of infections identified from the agent-based model"}]}
{"nct_id":"NCT04639791","start_date":"2021-03-01","enrollment":500,"brief_title":"To Assess the Management of Patients on Global Initiative of Asthma (GINA) Step 4 and 5 Treatment in Hong Kong","official_title":"To Assess the Management of Patients on Global Initiative of Asthma (GINA) Step 4 and 5 Treatment in Hong Kong","primary_completion_date":"2024-01-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2024-12-31","last_update":"2021-07-28","description":"This study aims to prospectively assess the asthma control and management of asthma patients who are on step 4, 5 asthma of GINA in Hong Kong (on at least medium-dose ICS-LABA as controller therapy for asthma) and also observe their exacerbations over 2 years. In addition, this study will also assess patients who are on biologics for their suitability and outcome. The investigators hope this study will be able to provided data regarding the management and outcome of patients who have difficult-to-treat and severe asthma. The investigators plan to build a biologic registry for asthma that would be able to help local doctors to gain experience to the use of these new and expensive medications. This is a multi-centre study involving public hospitals in Hong Kong. This study is important as this will generate local data for healthcare planning for severe asthma in Hong Kong.","other_id":"Severe Asthma Management_v2","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Asthma patients who are on Steps 4 and 5 of GINA asthma therapy","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Asthma patients with age 18. Asthma is defined as those with a consistent history and\r\n             prior documented evidence of variable airflow obstruction.\r\n\r\n          -  Subjects on steps 4 and 5 of GINA asthma therapy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with respiratory diseases with other known respiratory diseases including\r\n             chronic obstructive pulmonary disease, bronchiectasis, tuberculosis (TB)-destroyed\r\n             lung parenchyma, history of lung resection and lung cancer\r\n\r\n          -  Individuals older than 40 years with a smoking history of more than 10 pack-years\r\n\r\n          -  Pregnant women\r\n      ","sponsor":"Chinese University of Hong Kong","sponsor_type":"Other","conditions":"Asthma","interventions":[{"intervention_type":"Other","name":"Other: No intervention","description":"Observation only, no intervention"}],"outcomes":[{"outcome_type":"primary","measure":"Level of asthma control","time_frame":"24 months","description":"By GINA 2020 criteria of well-controlled, partly controlled or uncontrolled asthma"},{"outcome_type":"primary","measure":"Asthma Exacerbation","time_frame":"24 months","description":"Exacerbation that requires treatment with oral steroid (for patients on maintenance oral steroid, then increase in dose of the oral steroid)."},{"outcome_type":"primary","measure":"Hospitalization for asthma","time_frame":"24 months","description":"Number of hospitalization for asthma"}]}
{"nct_id":"NCT04789057","start_date":"2021-03-01","phase":"Phase 4","enrollment":460,"brief_title":"Atorvastatin Effect on Reduction of COPD Exacerbations","official_title":"Non-commercial Clinical Trial of Statins CAncer Preventive and Pleiotropic TherApy IN Smokers With Chronic Obstructive Pulmonary Disease (COPD)","primary_completion_date":"2025-12-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2025-12-31","last_update":"2021-03-09","description":"It is a randomized, multicenter, prospective, double-blind, placebo controlled, interventional clinical trial that will be conducted in Poland, in about 12 Hospital Pulmonary Departments to evaluate the effectiveness of atorvastatin on the reduction of inflammation process in patients with chronic obstructive pulmonary diseases, and possible biomarkers for personalized treatment of COPD.","other_id":"2019/ABM/01/00074","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":40,"maximum_age":99,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Subject has signed Informed Consent Form and is able to understand the purpose and\r\n             procedures required for the study and is willing to participate in the study.\r\n\r\n          2. Subject [male or female] is aged 40 years and older.\r\n\r\n          3. Subject is able to understand and comply with the protocol requirements and\r\n             instructions and is likely to complete the study as planned.\r\n\r\n          4. Patients with stable COPD with persistent airflow limitation (stable COPD\r\n             (post-bronchodilator FEV1<80% of the predicted normal and post-bronchodilator\r\n             FEV1/FVC<0,70 at visit 1.) Stage II- IV) and with moderate to very severe airflow\r\n             limitation according to GOLD guidelines.\r\n\r\n          5. At least two moderate/severe COPD exacerbations, or at least one leading to\r\n             hospitalization or ICU admission within 12 months, preceding screening visit.\r\n\r\n          6. Current or ex-smokers who have a smoking history of at least 10 pack years.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Contraindication to statin therapy included but not limited to: known poliomyelitis,\r\n             motor neuron disease, cranial or temporal arteritis, stroke or myopathy.\r\n\r\n          2. Statin use within the last 3 months prior to study start.\r\n\r\n          3. Prior diagnosis of statin induced myopathy or hypersensitivity reaction to another\r\n             HMG-CoA-reductase inhibitor.\r\n\r\n          4. Using e-cigarettes or I IQOS tobacco heating system.\r\n\r\n          5. Pregnant or nursing (lactating) women.\r\n\r\n          6. Women of child bearing potential, unless they are using effective method of\r\n             contraception during dosing of study treatment.\r\n\r\n          7. Patient with a clinically significant abnormality at visit 1 in investigator opinion.\r\n\r\n          8. Patients with a clinically relevant laboratory abnormality at visit 1 in investigator\r\n             opinion.\r\n\r\n          9. Patients with a history of malignancy of any organ system (including lung cancer).\r\n\r\n         10. Patients unable to perform acceptable spirometry and lung volumes procedures.\r\n\r\n         11. Patients who had a COPD exacerbations that required treatment with antibiotics and/or\r\n             oral corticosteroids and/or hospitalization in the 6 weeks prior to visit 1.\r\n\r\n         12. Patients who have had a respiratory tract infection within 4 weeks prior to visit1.\r\n\r\n         13. Patients requiring oxygen therapy (>15hr/day) on a daily basis for chronic hypoxemia.\r\n\r\n         14. Patients with a history of asthma or onset of symptoms prior to age 40 years\r\n\r\n         15. Patients with concomitant pulmonary disease (e.g. lung fibrosis, sarcoidosis,\r\n             interstitial lung disease, pulmonary hypertension, tuberculosis).\r\n\r\n         16. Patients with primary bronchiectasis.\r\n\r\n         17. Patients with a diagnosis of -1 antitrypsin deficiency (AATD).\r\n\r\n         18. Patients with pulmonary lobectomy or lung volume reduction surgery or lung\r\n             transplantation.\r\n\r\n         19. Active abuse of drugs or alcohol, poor compliance anticipated.\r\n\r\n         20. Use concomitant medications that are known to interact with atorvastatin: warfarin and\r\n             other coumarin (vitamin K antagonists) anticoagulants, cyclosporin, gemfibrozil or\r\n             other non or selective nonsteroidal anti-inflammatory drugs, proton pump inhibitors\r\n             (PPIs) used by last 6 months.\r\n\r\n         21. Patients participating in or planning to participate in the active phase of a\r\n             supervised pulmonary rehabilitation program during the study.\r\n\r\n         22. Use of other investigational drugs within 30 days or 5 half-lives, whichever is\r\n             longer, prior to screening visit.\r\n\r\n         23. Those unable in the opinion of the Investigator to comply fully with the study\r\n             requirements.\r\n      ","sponsor":"Medical University of Bialystok","sponsor_type":"Other","conditions":"Copd|COPD Exacerbation|Smoking|Gene Expression|Atorvastatin","interventions":[{"intervention_type":"Drug","name":"Drug: Atorvastatin 40 Mg Oral Tablet","description":"p.o., once daily"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"p.o., once daily"}],"outcomes":[{"outcome_type":"other","measure":"Changes in blood pressure","time_frame":"56 weeks","description":"The changes in blood pressure from Visit 1 will be evaluated at Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7, and changes from Visit 1 will be calculated, as well as compared between studied groups."},{"outcome_type":"other","measure":"Changes in hematology results","time_frame":"56 weeks","description":"The changes in hematology results from visit Visit 1 will be evaluated, at Visit 3, Visit 5, and Visit 7, as well as the differences between studied groups will be compared."},{"outcome_type":"primary","measure":"COPD exacerbation rate","time_frame":"56 weeks","description":"The exacerbation of the disease (defined as an acute worsening of respiratory symptoms that results in additional therapy) will be measured during the study treatment and follow-up phases, and compared between studied groups."},{"outcome_type":"primary","measure":"Time to the COPD exacerbation","time_frame":"56 weeks","description":"The time to the first exacerbation will be compared between the Intervention and Placebo groups."},{"outcome_type":"secondary","measure":"Changes in forced expiratory volume in the first second (FEV1)","time_frame":"56 weeks","description":"The differences in absolute value between Placebo and Atorvastatin group will be evaluated in time points [Visit 1 ,Visit 3,Visit 4, Visit 5, Visit 6 and Visit 8], and the relative change between Visit 1 and following time points [Visit 3 - Visit 8] in both arms will be compared."},{"outcome_type":"secondary","measure":"Changes in health-related quality of life","time_frame":"56 weeks","description":"The St George's Respiratory Questionnaire (SGRQ) score will be used and the differences in absolute value between Placebo and Atorvastatin group will be evaluated in time points [Visit 2 , Visit 5, and Visit 7], as well as the - relative change between Visit 2 and following time points [Visit 5 and Visit 7] in both arms will be compared. Scores range from 0 to 100; higher scores indicating more limitations."},{"outcome_type":"secondary","measure":"Changes of inflammatory pathway gene expression","time_frame":"56 weeks","description":"The gene expression will be evaluated in the peripheral blood leucocytes (PBL) by RNA-seq analysis, at visit Visit 1, Visit 2, Visit 5 and Visit 7, and the differences between Placebo and Atorvastatin groups will be analyzed, as well as a relative change between visits Visit 1 and Visit 2, Visit 5 and Visit 7 in both arms will be compared."},{"outcome_type":"secondary","measure":"Changes in peripheral blood leucocyte count","time_frame":"56 weeks","description":"The peripheral blood leucocytes count will be measured and the differences in absolute values between Placebo and Atorvastatin group will be calculated in time points Visit 1 ,Visit 3, Visit 5 and Visit 7, as well as a relative change between visits Visit 1 and Visit 2, Visit 3, Visit 5 , Visit 7 in both arms will be compared."},{"outcome_type":"secondary","measure":"Changes in the blood fibrinogen concentrations","time_frame":"56 weeks","description":"A blood fibrinogen concentration will be measured and the differences in absolute values between Placebo and Atorvastatin group will be calculated in time points Visit 1 ,Visit 3, Visit 5 and Visit 7, as well as a relative change between visits Visit 1 and Visit 2, Visit 3, Visit 5 , Visit 7 in both arms will be compared."},{"outcome_type":"secondary","measure":"Changes in the blood Interleukin-6 concentrations","time_frame":"56 weeks","description":"The Interleukin-6 blood concentrations will be measured and the differences in absolute values between Placebo and Atorvastatin group will be calculated in time points Visit 1 ,Visit 3, Visit 5 and Visit 7, as well as a relative change between visits Visit 1 and Visit 2, Visit 3, Visit 5 , Visit 7 in both arms will be compared."},{"outcome_type":"secondary","measure":"Changes in the blood high sensitivity C - reactive protein concentrations","time_frame":"56 weeks","description":"The blood high sensitivity C - reactive protein concentrations will be measured and the differences in absolute values between Placebo and Atorvastatin group will be calculated in time points Visit 1 ,Visit 3, Visit 5 and Visit 7, as well as a relative change between visits Visit 1 and Visit 2, Visit 3, Visit 5 , Visit 7 in both arms will be compared."},{"outcome_type":"other","measure":"Change from baseline in pre-dose values of plethysmography","time_frame":"56 weeks","description":"The functional residual volume (FRC) will be evaluated at Visit 2, Visit 5 and Visit 7, and changes from Visit 1 will be calculated, as well as compared between studied groups."},{"outcome_type":"other","measure":"Change in Inspiratory capacity (IC)","time_frame":"56 weeks","description":"The Inspiratory capacity (IC) will be evaluated will be evaluated at Visit 2, Visit 5 and Visit 7, and changes from Visit 1 will be calculated, as well as compared between studied groups."},{"outcome_type":"other","measure":"Change in 6 minute walking distance (6MWD) test result","time_frame":"56 weeks","description":"The 6MWD tests will be performed at Visit 2, Visit 5 and Visit 7, and changes from Visit 1 will be calculated, as well as compared between studied groups."},{"outcome_type":"other","measure":"The rate of hospitalizations (pulmonary or MACE)","time_frame":"56 weeks","description":"The number of hospitalizations during the treatment and follow-up phases will be evaluated, and compared between studied groups."},{"outcome_type":"other","measure":"Changes in heart rate (HR)","time_frame":"56 weeks","description":"The changes in HR from Visit 1 will be evaluated at Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7, and changes from Visit 1 will be calculated, as well as compared between studied groups."},{"outcome_type":"other","measure":"Changes in biochemistry results","time_frame":"56 weeks","description":"The changes in biochemistry results from visit Visit 1 will be evaluated, at Visit 3, Visit 5, and Visit 7, as well as the differences between studied groups will be compared."},{"outcome_type":"other","measure":"Changes in lipids profile","time_frame":"56 weeks","description":"The changes in lipids profile results from visit Visit 1 will be evaluated, at Visit 3, Visit 5, and Visit 7, as well as the differences between studied groups will be compared."},{"outcome_type":"other","measure":"Changes in blood glucose levels","time_frame":"56 weeks","description":"The changes in blood glucose concentrations from Visit 1 will be evaluated at Visit 7, and compared between studied groups."},{"outcome_type":"other","measure":"Changes in HbA1c levels","time_frame":"56 weeks","description":"The changes in HbA1c levels from Visit 1 will be evaluated at Visit 7, and compared between studied groups."},{"outcome_type":"other","measure":"Changes in the blood AspAT and ALAT concentrations","time_frame":"56 weeks","description":"The changes in blood AspAT and ALAT concentrations from Visit 1 will be evaluated, at Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7, and compared between studied groups."},{"outcome_type":"other","measure":"Changes in the blood CPK concentrations","time_frame":"56 weeks","description":"The changes in blood CPK concentrations from Visit 1 will be evaluated, at Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7, and compared between studied groups."},{"outcome_type":"other","measure":"Change in a transfer factor of the lung for carbon monoxide (DLCO)","time_frame":"56 weeks","description":"The DLCO will be evaluated at Visit 2, Visit 5 and Visit 7, and the changes from Visit 1 will be calculated, as well as compared between studied groups."}]}
{"nct_id":"NCT04765501","start_date":"2021-03-01","enrollment":80,"brief_title":"Cross-cultural Adaptation, Reliability and Validity of the Turkish Version of the Headache Impact Questionnaire","official_title":"Cross-cultural Adaptation, Reliability and Validity of the Turkish Version of the Headache Impact Questionnaire","primary_completion_date":"2022-09-01","study_type":"Observational","rec_status":"Recruiting","completion_date":"2022-09-01","last_update":"2021-05-04","description":"The purpose of this study was to investigate cultural adaptation, reliability and validity of the Turkish version of the Headache Impact Questionnaire (HIQ).","other_id":"E-77082166-604.01.02-27514","observational_model":"Other","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":70,"population":"The study population will consist of individuals with any type of headache.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosed with any type of headache,\r\n\r\n          -  Have a chronic headache.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Having a cognitive and neurological disorders.\r\n      ","sponsor":"Gazi University","sponsor_type":"Other","conditions":"Headache|Headache Disorders|Headache, Migraine|Headache, Tension|Headaches Chronic|Headaches Muscular","interventions":[{"intervention_type":"Other","name":"Other: Survey study","description":"Headache Impact Questionnaire (HIQ) will be applied."}],"outcomes":[{"outcome_type":"primary","measure":"Headache Impact Questionnaire (HIQ)","time_frame":"15 minutes","description":"Headache Impact Questionnaire is designed to measure the quality of life related to the disability"}]}
{"nct_id":"NCT04751890","start_date":"2021-03-01","phase":"N/A","enrollment":60,"brief_title":"Structured Home-based Exercise Versus Walking Advice in Claudication Patients: a Randomized-controlled Trial","official_title":"Effectiveness of a Home-based Structured Exercise Program Versus Walking Advice in Patients With Peripheral Artery Disease: a Randomized-controlled Trial","primary_completion_date":"2022-09-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-12-31","last_update":"2021-04-30","description":"A recent position paper calls for effective home-based exercise program for patients with peripheral artery disease (PAD) and claudication to be implemented in real-world care. This randomized-controlled trial aims to test the effects on mobility, hemodynamics and cardiovascular outcomes of a structured home-based exercise program (SHB) compared to walking advice (WA) recommendation intended as usual care, in PAD patients. Male and females PAD patients at Leriche-Fontaine's stage II and aged more than 60 years old will be enrolled. Patients will be randomized in SHB or WA groups. Patients of SHB group will receive a prescription of a home-based walking program during serial testing sessions at the hospital. The program will include two 10-minute sessions/day (6 days/week) of intermittent walking (1-minute work and 1-minute rest while seated) at a prescribed speed converted into a walking cadence and followed at home using a metronome. Two follow-up visits (at weeks 8 and 16) will be performed to evaluate patient adherence and to update the exercise program by increasing the walking speed. Patients randomized in WA group will receive the advice to walk as suggested by the guidelines. In particular, patients will be recommended to gather almost 30 minutes of walking at least 3 times per week; when they will face claudication pain, they will be allowed to rest and restart walking as soon as possible. Outcome measures will be performed at the entry prior to randomization, at the end of exercise programs (6-month) and after 12-month follow up. Primary outcomes will be the pain-free walking distance and the 6-minute walking distance collected during the 6-minute walking test Secondary outcomes will include ankle-brachial index, quality of life, lower limb strength and long-term clinical outcomes including revascularization and mortality.","other_id":"898/2020/Sper/AOUFe","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  male and females aged > 60 years old\r\n\r\n          -  peripheral artery disease at Leriche-Fontaine's stage 2a or 2b\r\n\r\n          -  cognitive functioning to give informed consent identified by a Mini Mental Status\r\n             Examination score 18/30.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  peripheral artery disease at Leriche-Fontaine's stage 1\r\n\r\n          -  peripheral artery disease at Leriche-Fontaine's stage 3 or more\r\n\r\n          -  severe cardio-respiratory conditions (e.g. unstable angina; severe heart failure\r\n             identified by New York Heart Association class III or IV)\r\n\r\n          -  neurological or musculoskeletal conditions (e.g. above knee amputation)\r\n             contraindicating or inhibiting exercise training.\r\n\r\n          -  very good exercise capacity determined by a 6-minute walking distance > 500 meters.\r\n      ","sponsor":"University Hospital of Ferrara","sponsor_type":"Other","conditions":"Peripheral Artery Disease","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Structured home-based exercise","description":"Low-intensity interval walking program prescribed at hospital and performed at daily at home"},{"intervention_type":"Behavioral","name":"Behavioral: Walking advice","description":"Walking advice according to the guidelines for peripheral artery disease patients"}],"outcomes":[{"outcome_type":"primary","measure":"6-Minute Walking Test (mobility)","time_frame":"Change at 6-month (end of training) respect to baseline","description":"Subjects will be instructed to walk as far as possible on a 21m walkway in 6 minutes, with their habitual walking device, with the possibility to slow down and rest if necessary. The total distance walked, the pain-free walking distance, and the perceived exertion at the end of the test will be recorded."},{"outcome_type":"secondary","measure":"Ankle Brachial Index (hemodynamics)","time_frame":"Change at 6-month (end of training) respect to baseline","description":"The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium). The ABI is calculated by dividing the systolic blood pressure measured at the ankle for both limbs with the patient in supine position by the systolic blood pressure in the arm."},{"outcome_type":"secondary","measure":"Vascu-QoL-6 (health-related quality of life)","time_frame":"Change at 6-month (end of training) respect to baseline","description":"This questionnaire consists of 6 items with a score ranging from 1 to 4 examining various aspects of disease-related quality of life. Higher scores correspond to better quality of life."},{"outcome_type":"secondary","measure":"5-time sit-to-stand test (lower limbs strength)","time_frame":"Change at 6-month (end of training) respect to baseline","description":"This test consists in moving from a sitting position to a standing position on a 42- cm high chair as quick as possible, for five times, with arms folded across the chest. Time will be taken when the test starts, and when the patient lay his/her buttocks on the chair for the fifth time."},{"outcome_type":"secondary","measure":"Foot temperature","time_frame":"Change at 6-month (end of training) respect to baseline","description":"Foot temperature will be noninvasively measured through an infrared thermal imaging camera at the dorsum of each foot at three points"},{"outcome_type":"secondary","measure":"Number and rate of hospitalizations","time_frame":"6-month, 12-month and 24-month (follow up)","description":"Number and rate of all-cause hospitalizations within participants will be collected."},{"outcome_type":"secondary","measure":"Number and rate of mortality","time_frame":"6-month, 12-month and 24-month (follow up)","description":"Number and rate of all-cause mortality within participants will be collected."}]}
{"nct_id":"NCT04775589","start_date":"2021-03-01","phase":"N/A","enrollment":20,"brief_title":"Telehealth Stepped Exercise Program for Rural Veterans With Knee Osteoarthritis","official_title":"Telehealth Stepped Exercise Program for Rural Veterans With Knee Osteoarthritis","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2021-12-31","last_update":"2021-03-02","description":"The goal of this study is to evaluate a telehealth Stepped Exercise Program for Knee OsteoArthritis (STEP-KOA) among rural veterans. Methods: This is a single arm, pre-post pilot trial of the 6-month STEP-KOA program among rural Veterans with a physician diagnosis of knee OA who self-report knee pain 3 on a 0-10 scale and self-reported difficulty with either walking or stair climbing. We aim to enroll 20 Veterans in this project but may enroll up to 30 in order to obtain sufficient information to evaluate the program, particularly among Veterans who live in very rural areas. Assessments will be conducted via a combination of telephone and video at baseline and 2-, 4-, and 6-month follow-up. Assessments will include questionnaires related to pain, function and physical activity, as well as several physical performance tests. STEP-KOA begins with a low cost, primarily self-directed exercise program (supported by an internet-based tool; Step 1). Patients are then assessed for degree of improvement in symptoms, and then can step up sequentially to telephone or video-based physical activity coaching (Step 2) and physical therapy (Step 3) if they do not make clinically relevant improvements in prior steps. For this project, patients will be assessed approximately every 2 months to determine step progression. Participants will advance to the next step if they do not meet response criteria for pain and function established by the Outcome Measures in Rheumatology group and the Osteoarthritis Research Society International (OMERACT-OARSI). The Step 2 intervention involves bi-weekly telephone or video calls. Step 3 involves 3 telehealth PT visits, based on standard care for knee OA.","other_id":"15997","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Rural dwelling Veterans (VA healthcare users)\r\n\r\n          -  Clinician diagnosis of knee osteoarthritis\r\n\r\n          -  Self-reported knee pain =>3 on a scale of 0-10 and self-reported difficulty either\r\n             walking or stair climbing.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Advanced Dementia\r\n\r\n          -  Psychosis\r\n\r\n          -  Active substance abuse disorder\r\n\r\n          -  Meniscus or ACL tear in the past 6 months\r\n\r\n          -  Total joint replacement or other major lower extremity surgery in the past 6 months\r\n\r\n          -  Severe hearing or visual impairment (e.g. unable to participate in STEP-KOA\r\n             intervention components)\r\n\r\n          -  Serious / terminal illness\r\n\r\n          -  Unstable angina\r\n\r\n          -  History of ventricular tachycardia\r\n\r\n          -  Unstable chronic obstructive pulmonary disease (two hospitalizations within the\r\n             previous 12 months and/or on oxygen)\r\n\r\n          -  Uncontrolled hypertension (diastolic blood pressure >110 mm/Hg or systolic > 200mm/Hg)\r\n\r\n          -  Stroke with moderate to severe aphasia\r\n\r\n          -  Recent history of falls\r\n\r\n          -  Resident of a long-term care facility\r\n\r\n          -  Hospitalization for a cardiovascular condition in the past 3 months\r\n\r\n          -  Other health conditions that would make home exercise unsafe or participation in the\r\n             program not feasible\r\n      ","sponsor":"Durham VA Medical Center","sponsor_type":"U.S. Fed","conditions":"Knee Osteoarthritis","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Stepped Exercise for Knee Osteoarthritis","description":"Patients start with a home-based exercise program, supported by an internet-based tool (Step 1). Patients are then assessed for degree of improvement in symptoms, and then can step up sequentially to telephone or video-based physical activity coaching (Step 2) and physical therapy (Step 3) if they do not make clinically relevant improvements in prior steps"}],"outcomes":[{"outcome_type":"primary","measure":"Western Ontario and McMaster Universities Osteoarthritis Index","time_frame":"Baseline to 6 months","description":"24-item measure assessing lower extremity pain, stiffness and function. All items are measured on a 5-point Likert scale (0-4; total score 0-96), with higher scores indicating worse symptoms."},{"outcome_type":"secondary","measure":"30-second chair stand test","time_frame":"Baseline to 6 months","description":"Participants are asked to rise and sit back down in a chair as many times as they can during 30 seconds, without using hands or arms for support. Higher numbers of chair stands indicate better function."},{"outcome_type":"secondary","measure":"2 minute march test","time_frame":"Baseline to 6 months","description":"Participants are asked to march in place, taking as many \"steps\" as they can within 2 minutes, bringing the knees to approximately a 90-degree angle. If the patient is not bringing knees to an appropriate height, the study team member administering the test will ask them to raise their knees higher; if proper knee height cannot be maintained, the patient may continue the test, but this is noted on the score sheet. Higher numbers of steps indicate better function."}]}
{"nct_id":"NCT04729153","start_date":"2021-02-28","enrollment":100,"brief_title":"Impact of Previous Treatment of HCV Patients by DAADs on Covid-19 Disease Frequency and Severity","official_title":"Impact of Previous Treatment of HCV Patients by DAADs on Covid-19 Disease Frequency and Severity","primary_completion_date":"2022-02-28","study_type":"Observational","rec_status":"Not yet recruiting","completion_date":"2022-03-31","last_update":"2021-02-03","description":"Evaluate effect of DAADs on covid-19 disease.","other_id":"DAADs and covid-19","observational_model":"Case-Control","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":70,"population":"Retrospective study","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. HCV patient with or without LC.\r\n\r\n          2. >18 years old.\r\n\r\n          3. Received DAADs at 2019.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Combined HCV and HIV infected patients.\r\n\r\n          2. Combined HCV and HBV infected patients.\r\n\r\n          3. < 18 years old.\r\n\r\n          4. Pregnant or breast-feeding patients.\r\n\r\n          5. Patients with autoimmune disease.\r\n\r\n          6. Patients with multiorgan failure, active cancer, renal insufficiency.\r\n\r\n          7. Patients received immunosuppressive drugs.\r\n\r\n          8. Immune compromised patients.\r\n\r\n          9. Previous confirmed diagnosis of SARS-CoV-2 before starting DAAs.\r\n      ","sponsor":"Assiut University","sponsor_type":"Other","conditions":"Covid19","interventions":[{"intervention_type":"Drug","name":"Drug: DAAD Compound","description":"Sofosbuvir , Daclatasvir and ribavirin"}],"outcomes":[{"outcome_type":"primary","measure":"Evaluate the effect of DAADs on covid -19","time_frame":"12 months (from 1/2/2021 to 1/2/2022)","description":"If chronic HCV patients who received DAADs suspected to be infected by covid-19 by having findings suggest covid 19 infection in MSCT chest or clinically symptoms or confirmed by nasopharyngeal swab . And if infected what about severity , if they need hospital admission or oxygen therapy or mechanical ventilation ,if they still alive or died"}]}
{"nct_id":"NCT04849754","start_date":"2021-02-25","phase":"N/A","enrollment":30,"brief_title":"Analysis of the Evolution of SUVmax by Quantitative Analysis Method of Bisphosphonate Scintigraphy","official_title":"Analysis of the Evolution of SUVmax by Quantitative Analysis Method of Bisphosphonate Scintigraphy for the Follow-up of Patients With Transthyretin Amyloidosis Treated With Tafamidis","primary_completion_date":"2023-03-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2025-03-31","last_update":"2021-04-26","description":"Recently, treatment with tafamidis in patients with cardiac ATTR lead to a significant reduction in mortality. The Perugini score is commonly used on planar bone scans to differentiate cardiac ATTR from other amyloidosis or normal patients but fails to evaluate amyloid burden and patient prognosis. Although semi-quantitative methods have been suggested to evaluate the amyloid burden, there a need for quantitative methods for longitudinal assessment of the disease.","other_id":"2020-A01795-34","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patient, male or female, over 18 years of age\r\n\r\n          -  Patient diagnosed with transthyretin cardiac amyloidosis confirmed by scintigraphy\r\n\r\n          -  Patient with signed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with systemic AL amyloidosis\r\n\r\n          -  Protected patient : major under guardianship, tutorship or other legal protection,\r\n             deprived of liberty by judicial or administrative decision\r\n\r\n          -  Pregnant or breastfeeding woman\r\n      ","sponsor":"GCS Ramsay Sant pour l'Enseignement et la Recherche","sponsor_type":"Other","conditions":"Cardiac Amyloidosis","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: bone scintigraphy","description":"Bone scintigraphy"}],"outcomes":[{"outcome_type":"primary","measure":"Measurement of SUVmax by quantitative analysis by bisphosphonate scintigraphy","time_frame":"6 months"}]}
{"nct_id":"NCT04305431","start_date":"2021-02-25","phase":"N/A","enrollment":50,"brief_title":"Dietary Behavior Intervention in African Americans at Risk for Cardiovascular Disease","official_title":"Exploring a Dietary Behavior Intervention in African-Americans at Risk for Cardiovascular Disease: A Community Acceptability and Feasibility Study","primary_completion_date":"2022-11-05","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-08-01","last_update":"2021-07-02","description":"Background: The risk of heart disease among African Americans is still common despite a greater understanding of the disease and better approaches to managing it. Healthy cooking and eating patterns can help reduce the risk of heart disease. But things like access to grocery stores and knowledge of good nutrition can affect these healthy patterns. Researchers want to see if community-based programs can help. Objective: To learn about the cooking behaviors of African American adults at risk for heart disease. Also, to see if a community-based cooking intervention will affect home-cooking behaviors. Eligibility: African American adults 18 and older who live in Wards 7 and 8 of Washington, D.C., and have at least one self-reported risk factor for heart disease Design: Phase I participants will complete a survey. It asks about their medical history, lifestyle, stress level, and eating habits. They will take part in a focus group. During this, they will talk about what they eat and what foods are available to them. Participation lasts 1 day for 3 hours at Pennsylvania Avenue Baptist Church in Washington, D.C. Phase II participants will go to shared cooking events at Pennsylvania Avenue Baptist Church. These will be held once a week for 6 weeks. They will be led by a trained chef. Participants will visit the NIH Clinical Center 3 times. Transportation will be provided if they need it. They will have physical exams and have blood drawn. They will be interviewed and complete questionnaires. A dietician will review the food they eat. An occupational therapist will assess their cooking skills. They will keep a daily cooking journal. Participation lasts 18 weeks. ...","other_id":"200036","allocation":"N/A","intervention_model":"Sequential Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        -  FIRST PHASE:\r\n\r\n        A sample of AA adults (n= 20) living in Wards 7 or 8 of Washington, D.C. will be recruited\r\n        for this phase.\r\n\r\n        INCLUSION CRITERIA:\r\n\r\n        English-speaking\r\n\r\n        Self-identified AA adults (defined as age greater than or equal to 18)\r\n\r\n        Live in Wards 7 or 8 in Washington, D.C.\r\n\r\n        At least one self-reported risk factor for CV disease known by participant or told to\r\n        participant by a clinician within the last 12 months. Specific risk factors are:\r\n\r\n          -  overweight or obese (self-reported height and weight compute to BMI if needed greater\r\n             than or equal to 25)\r\n\r\n          -  elevated waist to hip ratio\r\n\r\n          -  elevated cholesterol\r\n\r\n          -  clinical hypertension or prehypertension\r\n\r\n          -  prediabetes\r\n\r\n          -  elevated fasting glucose level on laboratory report\r\n\r\n          -  current smoker or prior (within the past 12 months) smoker.\r\n\r\n        EXCLUSION CRITERIA:\r\n\r\n        Under the age of 18\r\n\r\n        Do not live in Wards 7 or 8 in Washington, D.C.No risk factors for CVD\r\n\r\n        Or adults not of AA descent (self-identified)\r\n\r\n        Non-English speaking\r\n\r\n        SECOND PHASE:\r\n\r\n        A sample of AA adults (n= 30) living in Wards 7 or 8 of Washington, D.C. will be recruited\r\n        for this phase.\r\n\r\n        INCLUSION CRITERIA:\r\n\r\n        English-speaking\r\n\r\n        Self-identified AA adults (defined as age greater than or equal to 18)\r\n\r\n        Who live in Wards 7 or 8 in Washington, D.C.\r\n\r\n        At least one self-reported risk factor for CV disease known by participant or told to\r\n        participant by a clinician within the last 12 months. Specific risk factors are:\r\n\r\n          -  overweight or obese (BMI greater than or equal to 25 )\r\n\r\n          -  elevated waist to hip ratio\r\n\r\n          -  elevated cholesterol\r\n\r\n          -  clinical hypertension or prehypertension\r\n\r\n          -  prediabetes\r\n\r\n          -  elevated fasting glucose level on laboratory report\r\n\r\n          -  current smoker or prior (within the past 12 months) smoker.\r\n\r\n        Willing to not attend or enroll in another cooking/culinary education program or class\r\n        during participation in this study\r\n\r\n        Not enrolled currently or in the prior 12 months (at time of recruitment) in another\r\n        ongoing cooking/culinary education program or class\r\n\r\n        EXCLUSION CRITERIA:\r\n\r\n        AAs who are not age greater than or equal to 18\r\n\r\n        AA Adults not living in Wards 7 or 8 in Washington, D.C.\r\n\r\n        AA adults without at least one risk factor for CVD\r\n\r\n        Or adults not of AA descent\r\n\r\n        Non-English speaking\r\n\r\n        Those enrolled currently or in the prior 12 months at time of recruitment in another\r\n        ongoing cooking/culinary education program or class\r\n\r\n        Those not willing to not attend or enroll in another cooking/culinary education program or\r\n        class during participation in this study\r\n      ","sponsor":"National Institutes of Health Clinical Center (CC)","sponsor_type":"NIH","conditions":"Diet|Cooking","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Cooking Intervention","description":"90-minute culinary education sessions."}],"outcomes":[{"outcome_type":"primary","measure":"Feasibility Measures","time_frame":"26 weeks","description":"Recruitment and retention/attrition Attendance/Dosage Participant burden Implementation- treatment fidelity; measures of home cooking behavior"},{"outcome_type":"primary","measure":"Facilitators and Barriers","time_frame":"26 weeks","description":"Cooking diaries Cooking Self-Efficacy Scale D.C. CHOC Cooking Survey Cooking and Food Provisioning Action Scale AMPS (cooking skill) score"},{"outcome_type":"secondary","measure":"Second Phase Secondary Outcome","time_frame":"18 weeks","description":"Social Network Index HPLP-II Perceived Stress Scale MESA Neighborhood Healthy Food Availability Scale Perceptions of Neighborhood Food Retail Outlets Neighborhood Satisfaction Food purchasing practices Self-rated Health Pittsburgh Sleep Quality Assessment International Physical Activity Questionnaire-Short Form Food Away from Home Purchasing Frequency Family Meals Eaten Together Grocery receipts CVD related laboratory biomarkers Antropometric mesurements"}]}
{"nct_id":"NCT04746105","start_date":"2021-02-24","phase":"Phase 1","enrollment":40,"brief_title":"A Clinical Pharmacology Study of TS-142 in Patients With Obstructive Sleep Apnea Hypopnea.","official_title":"A Study to Evaluate the Respiratory Safety of TS-142 in Patients With Obstructive Sleep Apnea Hypopnea.","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-12-31","last_update":"2021-03-05","description":"A study to evaluate the respiratory safety of TS-142 in patients with mild obstructive sleep apnea hypopnea.","other_id":"TS142-208","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":20,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Japanese male and female, age 20 years or older at the time of informed consent\r\n\r\n          -  Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth\r\n             edition (DSM-5) criteria for obstructive sleep apnea hypopnea\r\n\r\n          -  Other protocol defined inclusion criteria could apply\r\n\r\n        Exclusion Criteria:\r\n\r\n        Subjects who meet any of the following criteria will be excluded from this study:\r\n\r\n          -  Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth\r\n             edition (DSM-5) criteria excepting obstructive sleep apnea hypopnea and insomnia\r\n             disorder\r\n\r\n          -  Patients who have clinically significant respiratory dysfunction (bronchiectasis,\r\n             emphysema, asthma, etc.) other than obstructive sleep apnea hypopnea\r\n\r\n          -  Patients with percutaneous arterial oxygen saturation (SpO2) <94% by pulse oximetry at\r\n             visit 1\r\n\r\n          -  Other protocol defined exclusion criteria could apply\r\n      ","sponsor":"Taisho Pharmaceutical Co., Ltd.","sponsor_type":"Industry","conditions":"Patients With Mild Obstructive Sleep Apnea Hypopnea","interventions":[{"intervention_type":"Drug","name":"Drug: TS-142","description":"Subjects received single-dose of 10 mg of TS-142 (oral tablet)"},{"intervention_type":"Drug","name":"Drug: Dose-matched Placebo to TS-142","description":"Subjects received single-dose matched placebo to TS-142 (oral tablet)"}],"outcomes":[{"outcome_type":"primary","measure":"Least square mean difference of Apnea hypopnea index (AHI) from placebo","time_frame":"Day 1","description":"AHI is a number of apnea and hypopnea events per hour during sleep determined by polyso㎜ography (PSG)."},{"outcome_type":"secondary","measure":"Least square mean difference of the mean SpO2 in total sleep time from placebo","time_frame":"Day 1","description":"The SpO2 will be simultaneously measured with PSG. The mean SpO2 during sleep determined by PSG will be calculated."}]}
{"nct_id":"NCT04927195","start_date":"2021-02-23","phase":"Phase 1","enrollment":96,"brief_title":"EDP1867 Phase 1a/1b Study in Healthy Participants and Participants With Moderate Atopic Dermatitis and, Optionally, Moderate Psoriasis, and/or Mild Asthma","official_title":"A Phase 1a/1b, First in Human, Participant and Investigator-blind Sponsor-unblinded Randomized Placebo-controlled Multiple Dose Study of EDP1867 in Healthy Volunteers and Participants With Moderate Atopic Dermatitis and, Optionally, Moderate Psoriasis, and/or Mild Asthma","primary_completion_date":"2021-09-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-11-15","last_update":"2021-06-15","description":"This Phase 1 study will investigate the safety and tolerability of EDP1867 in healthy volunteers, participants with atopic dermatitis, and, optionally, in participants with psoriasis and/or asthma.","other_id":"EDP1867-101","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Key Inclusion Criteria:\r\n\r\n          1. Age  18 years to 65 years.\r\n\r\n          2. Participant has a body mass index of  18 kg/m2 to  35 kg/m2.\r\n\r\n          3. Participants who are overtly healthy as determined by medical evaluation including\r\n             medical history, physical examination, laboratory tests, and ECG monitoring at\r\n             Screening and at Baseline.\r\n\r\n             Additional Inclusion Criteria for Participants with Moderate Atopic Dermatitis\r\n\r\n          4. Participant has moderate atopic dermatitis with a minimum of 5% and a maximum of 40%\r\n             BSA involvement, and an IGA score of 2 or 3.\r\n\r\n          5. Participant has had a confirmed diagnosis of atopic dermatitis for at least 6 months.\r\n\r\n          6. All participants must be using an emollient and should continue to use this once daily\r\n             (or more, as needed) for at least 14 days prior to randomisation, and must continue\r\n             this treatment once daily (or more, as needed) throughout the study.\r\n\r\n             Additional Inclusion Criteria for Participants with Moderate Psoriasis\r\n\r\n          7. Participant has moderate plaque psoriasis with plaque covering BSA of 3% and 10% and\r\n             meets both of the following additional criteria:\r\n\r\n               1. PASI score of 6 and 15, and\r\n\r\n               2. PGA score of 2 or 3.\r\n\r\n          8. Participant has a confirmed diagnosis of plaque psoriasis for at least 6 months.\r\n\r\n             Additional Inclusion Criteria for Participants with Mild Asthma\r\n\r\n          9. Participant has a diagnosis of stable asthma for at least six months\r\n\r\n         10. FeNO of 40ppb.\r\n\r\n         11. FEV1 70% of predicted normal.\r\n\r\n        Key Exclusion Criteria:\r\n\r\n          1. Participant has received live attenuated vaccination within 6 weeks prior to Screening\r\n             or intends to have such a vaccination during the course of the study (non-live\r\n             vaccines are permitted).\r\n\r\n          2. Participant requires treatment with an anti-inflammatory drug during the study period.\r\n\r\n          3. Participant has an active infection (e.g. sepsis, pneumonia, abscess) or has had an\r\n             infection requiring antibiotic treatment within 6 weeks prior to study intervention\r\n             administration.\r\n\r\n          4. Participant has renal or liver impairment\r\n\r\n          5. Participant has active neoplastic disease or history of neoplastic disease within 5\r\n             years of Screening\r\n\r\n          6. Participant has undergone major surgery within 4 weeks prior to Screening.\r\n\r\n          7. Any known cardiac abnormality\r\n\r\n          8. Participant has a known history of human immunodeficiency virus (HIV)\r\n\r\n          9. Known, active hepatitis A, hepatitis B (HBV), or hepatitis C (HCV) infection\r\n\r\n         10. Participant with any type of GI tract disease\r\n\r\n         11. Participants with a history of any serious psychiatric condition; or on therapy for\r\n             any psychiatric condition\r\n\r\n         12. The participant has taken any over-the-counter (OTC) or prescription medication,\r\n             within 14 days prior to baseline (Day -1); or anticipates an inability to abstain from\r\n             these products for the duration of the study period\r\n\r\n         13. The participant has a significant history of drug abuse or regular use of illicit\r\n             drugs or a history of alcohol abuse within 1 year prior to Screening or has tested\r\n             positive for drugs of abuse or alcohol at Screening or at baseline.\r\n\r\n         14. The participant has had an acute, clinically significant illness within 30 days prior\r\n             to the first dose of study intervention.\r\n\r\n             Additional Exclusion Criteria for Participants with Atopic Dermatitis\r\n\r\n         15. Participant is receiving systemic immunosuppressive or non-biologic atopic dermatitis\r\n             therapy or has received such therapy within 4 weeks prior to Screening.\r\n\r\n         16. Participant has received treatment with biologic agents within 12 months prior to\r\n             first dose.\r\n\r\n         17. Participant continues to use topical medications, other than emollients, that could\r\n             affect atopic dermatitis 2 weeks prior to the start of dosing.\r\n\r\n         18. Participant intends to continue to use sunbeds and/or increase their sun exposure\r\n             significantly from their normal lifestyle\r\n\r\n             Additional Exclusion Criteria for Participants with Psoriasis\r\n\r\n         19. Psoriasis restricted to scalp, palm, and/or soles only.\r\n\r\n         20. Non-plaque type of psoriasis\r\n\r\n         21. Participant is receiving systemic immunosuppressive or nonbiologic psoriasis therapy\r\n             or has received such therapy within 4 weeks prior to Screening\r\n\r\n         22. Participant has received treatment with biologic agents within 12 months prior to\r\n             first dose.\r\n\r\n         23. Participant continues to use topical medications that could affect psoriasis within 2\r\n             weeks prior to the start of dosing\r\n\r\n         24. Participant intends to continue to use sunbeds and/or increase their sun exposure\r\n             significantly from their normal lifestyle\r\n\r\n             Additional Exclusion Criteria for Participants with Asthma\r\n\r\n         25. History of life-threatening asthma, or a visit to the emergency department for asthma\r\n             in the 6 months prior to screening, or exacerbation requiring oral corticosteroids\r\n             within the previous 3 months.\r\n\r\n         26. Smoker or nicotine user within the 3 months prior to screening; or a previous smoker\r\n             with a greater than 10 pack year history.\r\n\r\n         27. Other significant non-reversible pulmonary disease\r\n\r\n         28. Use of the following medicines within the specified time-frame prior to screening:\r\n\r\n               1. Long-acting inhaled 2-agonists: 8 weeks. Note: short-acting inhaled 2-agonists\r\n                  are permitted as required.\r\n\r\n               2. Anti-IgE therapy: 6 months\r\n\r\n               3. Inhaled corticosteroids: 8 weeks\r\n\r\n               4. Oral or Injected corticosteroids: 8 weeks\r\n\r\n               5. Intranasal or topical steroids: 4 weeks\r\n\r\n               6. Leukotriene antagonists: 2 weeks\r\n\r\n               7. Long-acting muscarinic antagonist: 8 weeks\r\n\r\n               8. Xanthines (excluding caffeine), anticholinergics, cromoglycates: 1 week.\r\n      ","sponsor":"Evelo Biosciences, Inc.","sponsor_type":"Industry","conditions":"Atopic Dermatitis|Psoriasis|Asthma","interventions":[{"intervention_type":"Drug","name":"Drug: EDP1867","description":"EDP1867 is an orally administered, pharmaceutical preparation of a single strain of bacteria"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo oral capsule"}],"outcomes":[{"outcome_type":"primary","measure":"Safety and tolerability measured through Adverse Events (AEs)","time_frame":"Day 1 to Day 70","description":"Number of participants with AEs by seriousness and relationship to treatment"},{"outcome_type":"primary","measure":"Safety and tolerability measured through lab measurements","time_frame":"Day 1 to Day 70","description":"Number of participants with clinically significant change from baseline (Day 0) in laboratory values"},{"outcome_type":"primary","measure":"Safety and tolerability measured through ECG","time_frame":"Day 1 to Day 70","description":"Number of participants with clinically relevant changes from baseline (Day 0) ECG parameters"},{"outcome_type":"primary","measure":"Safety and tolerability measured through physical examination","time_frame":"Day 1 to Day 70","description":"Physical examination will include, at a minimum, assessments of the cardiovascular, respiratory, oral cavity, GI and neurological systems. Height and weight will also be measured and recorded. Number of participants with clinically relevant changes from baseline (Day 0) physical examination parameters"},{"outcome_type":"primary","measure":"Safety and tolerability measured through vital signs","time_frame":"Day 1 to Day 70","description":"Blood pressure, pulse rate, respiratory rate, oxygen saturations and temperature will be assessed. Number of participants with clinically relevant changes in vital signs from baseline (Day 0)"},{"outcome_type":"secondary","measure":"Change in EASI score","time_frame":"Day 1 to Day 70","description":"The clinical improvement in subjects with atopic dermatitis will be measured using the change from baseline in EASI (Eczema Area and Severity Index) score"},{"outcome_type":"secondary","measure":"Percentage change in EASI score","time_frame":"Day 1 to Day 70","description":"The clinical improvement in subjects with atopic dermatitis will be measured using the percentage change from baseline in EASI (Eczema Area and Severity Index) score"},{"outcome_type":"secondary","measure":"Change in SCORAD score","time_frame":"Day 1 to Day 70","description":"The clinical improvement in subjects with atopic dermatitis will be measured using the change from baseline in SCORAD (SCORing Atopic Dermatitis) score"},{"outcome_type":"secondary","measure":"Percentage change in SCORAD score","time_frame":"Day 1 to Day 70","description":"The clinical improvement in subjects with atopic dermatitis will be measured using the percentage change from baseline in SCORAD (SCORing Atopic Dermatitis) score"},{"outcome_type":"secondary","measure":"Change in BSA","time_frame":"Day 1 to Day 70","description":"The clinical improvement in subjects with atopic dermatitis will be measured using the change from baseline in BSA (Body Surface Area)"},{"outcome_type":"secondary","measure":"Percentage change in BSA","time_frame":"Day 1 to Day 70","description":"The clinical improvement in subjects with atopic dermatitis will be measured using the percentage change from baseline in BSA (Body Surface Area)"},{"outcome_type":"secondary","measure":"Change in IGA x BSA","time_frame":"Day 1 to Day 70","description":"The clinical improvement in subjects with atopic dermatitis will be measured using the change from baseline in IGA x BSA [IGA = Investigator's Global Assessment, BSA = Body Surface Area]"},{"outcome_type":"secondary","measure":"Percentage change in IGA x BSA","time_frame":"Day 1 to Day 70","description":"The clinical improvement in subjects with atopic dermatitis will be measured using the percentage change from baseline in IGA x BSA [IGA = Investigator's Global Assessment, BSA = Body Surface Area]"},{"outcome_type":"secondary","measure":"Change in DLQI score","time_frame":"Day 1 to Day 70","description":"The clinical improvement in subjects with atopic dermatitis will be measured using the change from baseline in DLQI (Dermatology Life Quality Index) score"},{"outcome_type":"secondary","measure":"Change in POEM score","time_frame":"Day 1 to Day 70","description":"The clinical improvement in subjects with atopic dermatitis will be measured using the change from baseline in POEM (Patient-Oriented Eczema Measure) score"},{"outcome_type":"secondary","measure":"Change in Pruritis NRS average itch score","time_frame":"Day 1 to Day 70","description":"The clinical improvement in subjects with atopic dermatitis will be measured using the change from baseline in Pruritis NRS (Numerical Rating Scale) average itch score"},{"outcome_type":"secondary","measure":"Change in Pruritis NRS worst itch score","time_frame":"Day 1 to Day 70","description":"The clinical improvement in subjects with atopic dermatitis will be measured using the change from baseline in Pruritis NRS (Numerical Rating Scale) worst itch score"},{"outcome_type":"secondary","measure":"Achievement of EASI-50","time_frame":"Day 1 to Day 70","description":"The clinical improvement in subjects with atopic dermatitis will be measured using achievement of EASI-50 at day 70"},{"outcome_type":"secondary","measure":"Achievement of EASI-75","time_frame":"Day 1 to Day 70","description":"The clinical improvement in subjects with atopic dermatitis will be measured using achievement of EASI-75 at day 70"},{"outcome_type":"secondary","measure":"Achievement of IGA 0 or 1","time_frame":"Day 1 to Day 70","description":"The clinical improvement in subjects with atopic dermatitis will be measured using achievement of IGA 0 or 1 at day 70"},{"outcome_type":"secondary","measure":"Change in PASI score","time_frame":"Day 1 to Day 70","description":"The clinical improvement in subjects with psoriasis will be measured using change from baseline in PASI score (Psoriasis Area and Severity Index Score)"},{"outcome_type":"secondary","measure":"Percentage change in PASI score","time_frame":"Day 1 to Day 70","description":"The clinical improvement in subjects with psoriasis will be measured using percentage change from baseline in PASI score (Psoriasis Area and Severity Index Score)"},{"outcome_type":"secondary","measure":"Change in LSS","time_frame":"Day 1 to Day 70","description":"The clinical improvement in subjects with psoriasis will be measured using change from baseline in LSS (Lesion Severity Score)"},{"outcome_type":"secondary","measure":"Change in BSA","time_frame":"Day 1 to Day 70","description":"The clinical improvement in subjects with psoriasis will be measured using change from baseline in BSA (Body Surface Area)"},{"outcome_type":"secondary","measure":"Percentage change in BSA","time_frame":"Day 1 to Day 70","description":"The clinical improvement in subjects with psoriasis will be measured using percentage change from baseline in BSA (Body Surface Area)"},{"outcome_type":"secondary","measure":"Change in PGA x BSA","time_frame":"Day 1 to Day 70","description":"The clinical improvement in subjects with psoriasis will be measured using change from baseline in PGA x BSA [PGA= Physician's Global Assessment; BSA = Body Surface Area)"},{"outcome_type":"secondary","measure":"Percentage change in PGA x BSA","time_frame":"Day 1 to Day 70","description":"The clinical improvement in subjects with psoriasis will be measured using percentage change from baseline in PGA x BSA [PGA= Physician's Global Assessment; BSA = Body Surface Area)"},{"outcome_type":"secondary","measure":"Change in DLQI","time_frame":"Day 1 to Day 70","description":"The clinical improvement in subjects with psoriasis will be measured using change from baseline in DLQI (Dermatology Life Quality Index) score"},{"outcome_type":"secondary","measure":"Achievement of PASI-50","time_frame":"Day 1 to Day 70","description":"The clinical improvement in subjects with psoriasis will be measured using achievement of PASI-50 at Day 70"},{"outcome_type":"secondary","measure":"Achievement of PASI-75","time_frame":"Day 1 to Day 70","description":"The clinical improvement in subjects with psoriasis will be measured using achievement of PASI-75 at Day 70"},{"outcome_type":"secondary","measure":"Achievement of PGA of 0 or 1","time_frame":"Day 1 to Day 70","description":"The clinical improvement in subjects with psoriasis will be measured using achievement of PGA of 0 or 1 at Day 70"},{"outcome_type":"secondary","measure":"Change in FeNO","time_frame":"Day 1 to Day 70","description":"The clinical improvement in subjects with asthma will be measured using change from baseline in FeNO (Fractional exhaled Nitric Oxide)"},{"outcome_type":"secondary","measure":"Percentage change in FeNO","time_frame":"Day 1 to Day 70","description":"The clinical improvement in subjects with asthma will be measured using percentage change from baseline in FeNO"},{"outcome_type":"secondary","measure":"Change in FEV1","time_frame":"Day 1 to Day 70","description":"The clinical improvement in subjects with asthma will be measured using change from baseline in FEV1 (Forced Expiratory Volume)"},{"outcome_type":"secondary","measure":"Percentage change in FEV1","time_frame":"Day 1 to Day 70","description":"The clinical improvement in subjects with asthma will be measured using percentage change from baseline in FEV1 (Forced Expiratory Volume)"},{"outcome_type":"secondary","measure":"Change in FVC","time_frame":"Day 1 to Day 70","description":"The clinical improvement in subjects with asthma will be measured using change from baseline in FVC (Forced Vital Capacity)"},{"outcome_type":"secondary","measure":"Percentage change in FVC","time_frame":"Day 1 to Day 70","description":"The clinical improvement in subjects with asthma will be measured using percentage change from baseline in FVC (Forced Vital Capacity)"},{"outcome_type":"secondary","measure":"Change in FEV1/FVC ratio","time_frame":"Day 1 to Day 70","description":"The clinical improvement in subjects with asthma will be measured using change from baseline in FEV1/FVC ratio"},{"outcome_type":"secondary","measure":"Percentage change in FEV1/FVC ratio","time_frame":"Day 1 to Day 70","description":"The clinical improvement in subjects with asthma will be measured using percentage change from baseline in FEV1/FVC ratio"},{"outcome_type":"secondary","measure":"Change in PEF","time_frame":"Day 1 to Day 70","description":"The clinical improvement in subjects with asthma will be measured using change from baseline in PEF (Peak Expiratory Flow)"},{"outcome_type":"secondary","measure":"Percentage change in PEF","time_frame":"Day 1 to Day 70","description":"The clinical improvement in subjects with asthma will be measured using percentage change from baseline in PEF (Peak Expiratory Flow)"},{"outcome_type":"secondary","measure":"Change in number of exacerbations","time_frame":"Day 1 to Day 56","description":"The clinical improvement in subjects with asthma will be measured using change from baseline in number of exacerbations across the treatment period"},{"outcome_type":"secondary","measure":"Occurrence of any exacerbation","time_frame":"Day 1 to Day 56","description":"The clinical improvement in subjects with asthma will be measured using the occurrence of any exacerbation during the treatment period"},{"outcome_type":"secondary","measure":"Number of puffs of SABA medication","time_frame":"Day 1 to Day 56","description":"The clinical improvement in subjects with asthma will be measured using the number of puffs of SABA medication used in the 7 days prior to Day 28 and Day 56"},{"outcome_type":"secondary","measure":"Use of any SABA medication","time_frame":"Day 1 to Day 56","description":"The clinical improvement in subjects with asthma will be measured using the occurrence of use of any SABA medication during the treatment period"}]}
{"nct_id":"NCT04965623","start_date":"2021-02-22","phase":"N/A","enrollment":15,"brief_title":"ExplorATory Study oF the EdWards Transcatheter Atrial Shunt System (AlT FloW Germany)","official_title":"ExplorATory Study oF the EdWards Transcatheter Atrial Shunt System (AlT FloW Germany)","primary_completion_date":"2022-03-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2027-03-01","last_update":"2021-07-16","description":"The Exploratory Study of the Edwards Transcatheter Atrial Shunt System is a multi-center, prospective, exploratory study to evaluate initial clinical safety, device functionality, and effectiveness of the Edwards Transcatheter Atrial Shunt System.","other_id":"2018-14","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Signed and dated Ethics Committee (EC) approved study consent form prior to study\r\n             related procedures\r\n\r\n          2.  18 years old\r\n\r\n          3. Chronic symptomatic Heart Failure (HF) documented by the following:\r\n\r\n               1. NYHA class III or ambulatory NYHA class IV within last 12 months AND\r\n\r\n               2.  1 HF hospital admission (with HF as the primary, or secondary diagnosis); or\r\n                  treatment with intravenous (IV) or intensification of oral diuresis for HF in a\r\n                  healthcare facility (emergency department/acute care facility) within the 12\r\n                  months prior to study entry; OR an NT-pro BNP value > 150 pg./ml in normal sinus\r\n                  rhythm, > 450 pg./ml in atrial fibrillation, or a BNP value > 50 pg./ml in normal\r\n                  sinus rhythm, > 150 pg./ml in atrial fibrillation within the past 6 months.\r\n\r\n          4. In the judgment of the investigator, subject is on stable Guideline Directed Medical\r\n             Therapy (GDMT) for heart failure and management of potential comorbidities according\r\n             to current ACCF/AHA/ESC Guidelines and that is expected to be maintained without\r\n             change for 3 months\r\n\r\n          5. Elevated LA (or PCWP) pressure of > 15 mmHg at rest or > 25 mmHg during supine\r\n             ergometer exercise stress test, as measured at end-expiration; AND the LA (or PCWP)\r\n             exceeds right atrial pressure (RAP) by > 5 mmHg at rest or > 10 mmHg during supine\r\n             ergometer exercise stress test as measured at end-expiration\r\n\r\n          6. Willing to attend study follow-up assessments for up to 5 years\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Severe heart failure defined as one or more of the below:\r\n\r\n               1. ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF\r\n\r\n               2. If BMI < 30, Cardiac index < 2.0 L/min/m2\r\n\r\n               3. If BMI  30, cardiac index < 1.8 L/min/m2\r\n\r\n               4. Inotropic infusion (continuous or intermittent) within the past 6 months\r\n\r\n               5. Patient is on the cardiac transplant waiting list\r\n\r\n               6. LVEF < 20%\r\n\r\n          2. Presence of significant valve disease defined by the site cardiologist as:\r\n\r\n               1. Mitral valve regurgitation defined as grade > 3+ MR or > moderate MS\r\n\r\n               2. Tricuspid valve regurgitation defined as grade > 2+ TR\r\n\r\n               3. Aortic valve disease defined as > 2+ AR or > moderate AS\r\n\r\n          3. MI and/or any therapeutic invasive cardiac procedure within past 3 months; or current\r\n             indication for coronary revascularization\r\n\r\n          4. Valve replacement or surgical annuloplasty within the past 12 months\r\n\r\n          5. Stroke or transient ischemic attack (TIA) within the past 6 months\r\n\r\n          6. Hemodynamic instability within 30 days of scheduled implant procedure\r\n\r\n          7. Patient requiring surgery under general anesthesia for any reason within 30 days of\r\n             scheduled implant procedure\r\n\r\n          8. Clinically diagnosed hypertrophic obstructive cardiomyopathy, constrictive\r\n             pericarditis or other infiltrative cardiomyopathy (eg, hemochromatosis, sarcoidosis)\r\n             at the time of screening per central screening committee\r\n\r\n          9. Has renal insufficiency as determined by creatinine (S-Cr) level > 2.5 mg/dL or\r\n             estimated-GFR < 25ml/min/1.73 m2 by CKD-Epi equation; or currently requiring dialysis\r\n\r\n         10. Significant hepatic impairment defined as 3 upper limit of normal of transaminases,\r\n             total bilirubin, or alkaline phosphatase\r\n\r\n         11. Right ventricular dysfunction, defined by the site cardiologist as:\r\n\r\n               1. More than mild RV dysfunction as estimated by TTE; OR\r\n\r\n               2. TAPSE <1.4 cm; OR\r\n\r\n               3. RV size  LV size as estimated by TTE; OR\r\n\r\n               4. Echocardiographic or clinical evidence of congestive hepatopathy;\r\n\r\n         12. Evidence of pulmonary hypertension with PVR >4 Wood units\r\n\r\n         13. Performance of the 6 minute walk test with a distance <50m OR >600m\r\n\r\n         14. Subject is contraindicated to receive either dual antiplatelet therapy or warfarin\r\n             (analogue); or has a documented coagulopathy\r\n\r\n         15. Known hypersensitivity to anticoagulation therapy or contrast agent, which cannot be\r\n             adequately medicated\r\n\r\n         16. Known hypersensitivity to Nickel and/or Tantalum\r\n\r\n         17. In the judgment of the investigator, life expectancy <12 months for noncardiovascular\r\n             reasons\r\n\r\n         18. In the opinion of the investigator and Central Screening Committee, the subject is not\r\n             an appropriate candidate for the study\r\n\r\n         19. Anatomy or implantable device that is not compatible with or could potentially\r\n             interfere with the Edwards Transcatheter Atrial Shunt System as determined by the\r\n             Investigator and Central Screening Committee\r\n\r\n         20. Active endocarditis or infection within 3 months of scheduled implant procedure\r\n\r\n         21. Currently participating (e.g., undergoing trial specific exams/treatment/procedures)\r\n             in an investigational drug or device study. Note: trials requiring extended follow-up\r\n             for products that were investigational but have since become commercially available\r\n             are not considered investigational trials.\r\n\r\n         22. Patient is a current intravenous drug user\r\n\r\n         23. Positive serum pregnancy test in female subjects of child-bearing potential or nursing\r\n             mothers or planning on becoming pregnant during the duration of the trial\r\n\r\n         24. Patient is under guardianship\r\n\r\n         25. Known pre-existing shunting, determined to be clinically significant by the\r\n             investigator and Central Screening Committee\r\n\r\n         26. Patients with a CRT lead in the coronary sinus\r\n      ","sponsor":"Edwards Lifesciences","sponsor_type":"Industry","conditions":"Heart Failure","interventions":[{"intervention_type":"Device","name":"Device: Atrial Shunt","description":"Transcatheter treatment of symptomatic left heart failure patients"}],"outcomes":[{"outcome_type":"primary","measure":"Safety Endpoint","time_frame":"30 Days","description":"Composite of major adverse cardiac, cerebrovascular, renal events (MACCRE) and re-intervention for study device related complications at 30 days."},{"outcome_type":"secondary","measure":"Device Success","time_frame":"Day 0","description":"Device is deployed as intended and the delivery system is successfully removed as intended at the time of the patient's exit from the implant procedure room."},{"outcome_type":"secondary","measure":"Procedural Success","time_frame":"10 Days post-op","description":"Device success with evidence of shunt patency and hospital discharge without the need for additional surgical or percutaneous intervention related to the study device including unacceptable Qp/Qs values."},{"outcome_type":"secondary","measure":"Performance/Effectiveness","time_frame":"Baseline, 3 months, 6 months","description":"Comparison vs baseline of Qp/Qs value at 3 and 6 months"},{"outcome_type":"secondary","measure":"Performance/Effectiveness","time_frame":"Baseline, 3 months, 6 months","description":"Improvement vs baseline of PCWP under the same test conditions"}]}
{"nct_id":"NCT04769570","start_date":"2021-02-22","phase":"N/A","enrollment":90,"brief_title":"Effect of Interscalene and Suprascapular Nerve Block on Analgesia Consumption After Adhesive Capsulitis Surgery","official_title":"Effect of Interscalene and Suprascapular Nerve Block on Analgesia Consumption After Adhesive Capsulitis Surgery","primary_completion_date":"2022-03-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-03-01","last_update":"2021-03-12","description":"In this study, a combination of different types of blocks for adhesive capsulitis surgery, the investigators will investigate the impact on patient satisfaction and analgesic consumption after surgery.","other_id":"215/580","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  ASA I- ASA II Patients\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  history of allergy to the study medication\r\n\r\n          -  refusal to participate\r\n      ","sponsor":"TC Erciyes University","sponsor_type":"Other","conditions":"Shoulder Surgery","interventions":[{"intervention_type":"Procedure","name":"Procedure: interscalene brachial plexus block","description":"Single shot ultrasound guided interscalene brachial plexus block will be performed preoperatively to patients.Patient-controlled analgesia (PCA) with morphine will be used for postoperative analgesia."},{"intervention_type":"Procedure","name":"Procedure: suprascapular nerve block","description":"Single shot ultrasound guided interscalene brachial plexus block and Suprascapular nerve block will be performed preoperatively to patients.Patient-controlled analgesia (PCA) with morphine will be used for postoperative analgesia."},{"intervention_type":"Procedure","name":"Procedure: Group Control","description":"consist of the patient group without any procedure."}],"outcomes":[{"outcome_type":"primary","measure":"Verbal Analogue Scores","time_frame":"24 hours after surgery","description":"A research assistant, blinded to the group allocation, interviewed patients and collected data in the 24 hours postoperative period.Verbal Analog Pain Score value will be the lowest 0 and the highest 10. At the highest value, the patient's pain is at its maximum. and whether higher scores mean worse outcome."},{"outcome_type":"primary","measure":"opioid consumption","time_frame":"24 hours after surgery","description":"In the recovery room all patients will be given a patient-controlled analgesia device containing morphine and 24 hours postoperative period will be recorded."},{"outcome_type":"secondary","measure":"Complications of the procedures","time_frame":"During the blocks and 24 hours after surgery","description":"The complications of the intervations will be recorded"}]}
{"nct_id":"NCT04707196","start_date":"2021-02-22","phase":"Phase 4","enrollment":100,"brief_title":"A Study of Abemaciclib in Indian Women With Advanced Breast Cancer","official_title":"A Single-Arm, Phase 4 Study of Abemaciclib, a CDK4 and CDK6 Inhibitor, in Combination With Endocrine Therapy (Anastrozole/Letrozole or Fulvestrant) in Participants With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Locally Advanced and/or Metastatic Breast Cancer in India","primary_completion_date":"2022-08-16","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-08-16","last_update":"2021-08-05","description":"The main purpose of this study is to learn more about the safety and tolerability of abemaciclib when given in combination with hormone therapy in Indian women with advanced breast cancer. Participants must have hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer and must live in India. For each participant, the study could last up to eight months and may include up to eight visits to the study center.","other_id":"17782","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Have a diagnosis of hormone receptor-positive (HR+), human epidermal growth factor\r\n             receptor 2-negative (HER2-) breast cancer\r\n\r\n          -  Have locoregionally recurrent disease not amenable to resection or radiation therapy\r\n             with curative intent or metastatic disease\r\n\r\n          -  Have postmenopausal status\r\n\r\n          -  Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)\r\n             scale\r\n\r\n          -  Have adequate organ function\r\n\r\n          -  Have discontinued previous cytotoxic therapies, biological agents, investigational\r\n             agents, and radiotherapy\r\n\r\n          -  Are able to swallow oral formulation\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis.\r\n\r\n          -  Have clinical evidence or history of central nervous system metastasis.\r\n\r\n          -  Have received prior treatment with chemotherapy (except for neoadjuvant/adjuvant\r\n             chemotherapy), fulvestrant, everolimus, or any cyclin-dependent kinase (CDK) 4 & 6\r\n             inhibitor.\r\n\r\n          -  Have received recent (within 28 days prior to study intervention) live vaccination\r\n             (for example, yellow fever). Seasonal flu vaccinations that do not contain a live\r\n             virus are permitted.\r\n\r\n          -  Have a personal history of presyncope or syncope of either unexplained or\r\n             cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden\r\n             cardiac arrest.\r\n\r\n          -  Have inflammatory breast cancer or a history of any other cancer (except nonmelanoma\r\n             skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no\r\n             therapy for a minimum of 3 years.\r\n\r\n          -  Have received an autologous or allogeneic stem-cell transplant\r\n\r\n          -  Have clinically relevant active bacterial or fungal infection, or detectable viral\r\n             infection (for example, human immunodeficiency virus or viral hepatitis). Screening is\r\n             not required for enrolment.\r\n\r\n          -  Are pregnant or breastfeeding.\r\n      ","sponsor":"Eli Lilly and Company","sponsor_type":"Industry","conditions":"Breast Neoplasms|Neoplasm Metastasis","interventions":[{"intervention_type":"Drug","name":"Drug: Abemaciclib","description":"Administered orally"},{"intervention_type":"Drug","name":"Drug: Nonsteroidal Aromatase Inhibitor (NSAI)","description":"Letrozole administered orally or anastrozole administered orally (physician choice)"},{"intervention_type":"Drug","name":"Drug: Fulvestrant","description":"Administered intramuscularly"}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious)","time_frame":"Baseline through Month 6","description":"Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious)"},{"outcome_type":"secondary","measure":"Percentage of Participants who Discontinue from Study Treatment Due to Adverse Events","time_frame":"Baseline through Month 6","description":"Percentage of Participants who Discontinue from Study Treatment Due to Adverse Events"}]}
{"nct_id":"NCT04758364","start_date":"2021-02-20","enrollment":71,"brief_title":"Factors That Effect the Gait Speed in Diabetic Individuals Without Neuropathy","official_title":"Factors That Effect the Gait Speed in Diabetic Individuals Without Neuropathy","primary_completion_date":"2021-03-12","study_type":"Observational [Patient Registry]","rec_status":"Completed","completion_date":"2021-03-30","last_update":"2021-04-01","description":"This study planned to investigate the role of potential explanatory factors effecting the speed of gait such as muscle mass, aerobic capacity, physical activity status, cognitive function, blood pressure, and metabolic measures considering age, sex, and education years in diabetic individuals without neuropathy.","other_id":"60116787-020/75097","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":75,"population":"Type 2 Diabetic individuals without neuropathy","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Individuals with Diabetes Mellitus less than 10 years but longer than 1 year\r\n\r\n          -  Absence of neuropathic symptoms\r\n\r\n          -  DN4 questionnaire sore less than 4\r\n\r\n        Exclusion Criteria:\r\n\r\n        Individuals who had\r\n\r\n          -  insulin therapy,\r\n\r\n          -  poor glycemic control,\r\n\r\n          -  manifesting cardiovascular disease,\r\n\r\n          -  retinopathy or other visual problems,\r\n\r\n          -  diabetic neuropathy,\r\n\r\n          -  nephropathy,\r\n\r\n          -  cerebrovascular disease,\r\n\r\n          -  cognitive impairment,\r\n\r\n          -  heart failure,\r\n\r\n          -  alcohol or cigarette dependence,\r\n\r\n          -  cancer,\r\n\r\n          -  chemo/radiotherapy,\r\n\r\n          -  foot ulcer,\r\n\r\n          -  orthopedical or surgical problems\r\n\r\n          -  wheel-chair or any assistive devices for ambulation\r\n\r\n          -  prominent knee or hip arthritis, prosthesis\r\n      ","sponsor":"GULIN FINDIKOGLU","sponsor_type":"Other","conditions":"Gait Disorder, Sensorimotor|Diabetes Mellitus, Type 2","interventions":[{"intervention_type":"Other","name":"Other: measurement of gait speed","description":"Cross sectional, cohort"}],"outcomes":[{"outcome_type":"primary","measure":"gait speed","time_frame":"The gait speed will be measured once within a month after the participants enrolled.","description":"gait speed measured by wearable accelerometer"}]}
{"nct_id":"NCT04768829","start_date":"2021-02-18","phase":"Early Phase 1","enrollment":10,"brief_title":"Antifungal Potential of Moringa Olifera Against Otomycosis","official_title":"Antifungal Potential of Moringa Olifera-loaded Nanoparticles Against Otomycosis; Preparation, Characterization, and Clinical Evaluation","primary_completion_date":"2021-09-15","study_type":"Interventional","rec_status":"Enrolling by invitation","completion_date":"2021-12-01","last_update":"2021-07-21","description":"patients with Otomycosis were recognized by an ENT specialist. 20 patients were distributed randomly into two groups. The first group will be treated with Nystatin ear drops twice daily. The second group will be treated with Moringa ear drops. patients will be examined endoscopically by the ENT specialist. patient's swabs will be isolated and analyzed by ELISA.","other_id":"S85Motic","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"moringa extract ear drops","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Otomycosis\r\n\r\n          2. ear inflammation\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. tympanic membrane perforation\r\n\r\n          2. concurrent immune suppression,\r\n\r\n          3. concurrent bacterial infection.\r\n      ","sponsor":"Deraya University","sponsor_type":"Other","conditions":"Otomycosis","interventions":[{"intervention_type":"Drug","name":"Drug: Moringa oleifera leaf 10mg/100ml","description":"ear drops"},{"intervention_type":"Drug","name":"Drug: Ear Drop","description":"plain ear drop formulation without moringa"}],"outcomes":[{"outcome_type":"primary","measure":"Number of participants recovered with clear endoscopic examination","time_frame":"one week","description":"Number of participants recovered with clear endoscopic examination"},{"outcome_type":"primary","measure":"Identification of different microorganisms infected ear","time_frame":"up to 1 month","description":"Patients swabs (microorganisms concentration)"}]}
{"nct_id":"NCT04723537","start_date":"2021-02-16","phase":"Phase 2/Phase 3","enrollment":310,"brief_title":"Upamostat, a Serine Protease Inhibitor, or Placebo for Treatment of COVID-19 Disease","official_title":"Phase 2/3 Study of Upamostat, a Serine Protease Inhibitor, or Placebo for Treatment of COVID-19 Disease","primary_completion_date":"2022-09-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-09-30","last_update":"2021-09-20","description":"A 2-part, multicenter, Phase 2/3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of upamostat in adult patients with COVID-19 disease who do not require inpatient care.","other_id":"RHB-107-01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patients with symptomatic, diagnostically confirmed COVID-19, per RT-PCR or antigen\r\n             assay of respiratory tract sample.\r\n\r\n          2. Patient must have either become symptomatic or found positive by RT-PCR or antigen\r\n             assay within 5 days, whichever is greater, of randomization.\r\n\r\n          3. Patients must fill out a baseline questionnaire which is reviewed by study personnel\r\n             to determine eligibility.\r\n\r\n          4. Males and females age 18 years.\r\n\r\n          5. Oxygen saturation by pulse oximeter 92% on room air\r\n\r\n          6. Negative urine or serum pregnancy test (if woman of childbearing potential).\r\n\r\n          7. Females of childbearing potential and males with female partners of childbearing\r\n             potential must agree to use acceptable contraceptive methods during the study and for\r\n             at least two months after the last dose of study medication.\r\n\r\n          8. Ability to complete the daily diary independently.\r\n\r\n          9. The patient must give informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patient is in need of acute hospitalization per clinician assessment.\r\n\r\n          2. Pregnant or nursing women.\r\n\r\n          3. Unwillingness or inability to comply with procedures required in this protocol.\r\n\r\n          4. Patient requires supplemental oxygen.\r\n\r\n          5. Patient is currently receiving, has received within the past 7 days or is expected to\r\n             receive during the course of the study remdesivir, or other specific antiviral or\r\n             anticytokine therapy for COVID-19, other than therapeutic monoclonal antibodies\r\n             allowed or approved in the region in which the patient lives, or systemic\r\n             corticosteroid equivalent to 20 mg daily prednisone/3 mg dexamethasone daily.\r\n\r\n          6. Patient is currently receiving or has received within 30 days prior to screening any\r\n             other investigational agent for any indication, including approved agents given for\r\n             investigational indications (e.g., anti-cytokine treatments).\r\n\r\n          7. Patient is currently taking or is expected to start taking warfarin, apixaban\r\n             (Eliquis), or rivaroxaban (Xarelto). Patients may be taking or start on study\r\n             dabigatran (Pradaxa), standard or low molecular weight heparin.\r\n      ","sponsor":"RedHill Biopharma Limited","sponsor_type":"Industry","conditions":"Covid19","interventions":[{"intervention_type":"Drug","name":"Drug: Part A: Upamostat 200 mg","description":"1 capsule comprising 200 mg of upamostat and 1 capsule comprising matching placebo."},{"intervention_type":"Drug","name":"Drug: Part A: Upamostat 400 mg","description":"2 capsules, each capsule comprising 200 mg of upamostat"},{"intervention_type":"Drug","name":"Drug: Part A and B: Placebo","description":"1 or 2 capsules, each capsule a matching placebo"},{"intervention_type":"Drug","name":"Drug: Part B: Upamostat 200 or 400 mg","description":"Based on dose selection from Part A, \"Part B Upamostat\" will be EITHER a single 200 mg dose of upamostat OR two 200 mg doses of upamostat, for a total of 14 days."}],"outcomes":[{"outcome_type":"primary","measure":"Part A - Determination of the safety and tolerability of two dose levels and selection of an upamostat dose for part B","time_frame":"57 days","description":"Safety and tolerability will be determined based on the relative incidence and severity (CTCAE v 5.0 criteria) of adverse events, both clinical and laboratory (SOC=investigations) in each active treatment group as compared to placebo. In addition, toxicities (i.e., adverse events considered at lease possible related to study medication) resulting in dose reductions or discontinuation of therapy will be tabulated and compared among treatment groups."},{"outcome_type":"primary","measure":"Part B - Comparison between upamostat and placebo in time to sustained recovery from symptomatic illness.","time_frame":"57 days","description":"Sustained recovery: recovery maintained for at least 14 or 28 days or through EOS, whichever comes first (assessed in part A and a decision reached as to which period to use for definition of sustained recovery in part B). A patient will be considered to have recovered after meeting the following criteria: 1) is afebrile for at least 48 hours without use of antipyretics; 2) all symptoms have resolved or returned to pre- illness levels, except for: a. fatigue, anosmia, ageusia or dysgeusia, which may be persistent at level similar to that during the acute illness; b. chest pain, cough or dyspnea which if persistent must be at least one grade lower than at the start of treatment and no worse than grade 1 (mild)."},{"outcome_type":"secondary","measure":"Part B - Hospitalization or death from any cause by end of study","time_frame":"57 days","description":"Hospitalization or death from any cause within 8 weeks after the first dose of study medication"},{"outcome_type":"secondary","measure":"Part A and at Interim Analysis in Part B - assessment of risk of hospitilization or death","time_frame":"57 days","description":"Assessment of risk of hospitilization or death as a function of the presence, number and severity of concerning conditions will be undertaken. This information may be used to develop a definition of very high risk for calculation of the incidence of hospitilization or death in the high risk/very high risk population in part B"},{"outcome_type":"secondary","measure":"Part B - Proportion of patients who are PCR-negative at various time points during the study.","time_frame":"57 days","description":"Proportion of patients who are PCR-negative at days 8, 15, 29 and 57 from the start of treatment (landmark analyses)"},{"outcome_type":"secondary","measure":"Part B - Time to resolution of individual disease-related symptoms present at baseline","time_frame":"57 days","description":"Time to resolution of individual disease-related symptoms present at baseline"},{"outcome_type":"secondary","measure":"Part B - Development of new disease-related symptoms on study","time_frame":"57 days","description":"Development of new disease-related symptoms on study will be captured using the same questionnaire as is being used to capture resolution of symptoms."},{"outcome_type":"secondary","measure":"Part B - Development of pneumonia on study","time_frame":"57 days","description":"Incidence of pneumonia during study among patients without baseline pneumonia"},{"outcome_type":"secondary","measure":"Part B - Changes in laboratory markers of disease severity","time_frame":"57 days","description":"Changes in oxygen saturation from baseline to time points at which these are measured on study"},{"outcome_type":"secondary","measure":"Part B - Changes in laboratory markers of disease severity","time_frame":"57 days","description":"Changes in CRP from baseline to time points at which these are measured on study"},{"outcome_type":"secondary","measure":"Part B - Changes in laboratory markers of disease severity","time_frame":"57 days","description":"Changes in lymphocyte count from baseline to time points at which these are measured on study"},{"outcome_type":"secondary","measure":"Part B - Changes in laboratory markers of disease severity","time_frame":"57 days","description":"Changes in cardiac troponin from baseline to time points at which these are measured on study"},{"outcome_type":"secondary","measure":"Part B - Changes in laboratory markers of disease severity","time_frame":"57 days","description":"Changes in D-dimer levels from baseline to time points at which these are measured on study"},{"outcome_type":"secondary","measure":"Part B - Adverse events","time_frame":"57 days","description":"Adverse events"}]}
{"nct_id":"NCT03707236","start_date":"2021-02-15","phase":"N/A","enrollment":150,"brief_title":"The Use of Teledermatology in the Treatment of Patients With Severe Acne on Isotretinoin","official_title":"The Use of Teledermatology in the Treatment of Patients With Severe Acne on Isotretinoin: A Randomized-controlled Trial","primary_completion_date":"2021-06-01","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2021-12-01","last_update":"2020-12-02","description":"This is a non-blinded randomized controlled non-inferiority trial designed to assess the efficacy and role of teledermatology visits in the treatment of patients with severe acne starting isotretinoin. Males and females 16 years or older will be randomized to either the control arm (monthly office visits during treatment weeks 8-20) or treatment arm (teledermatology visits during treatment weeks 8-20). The primary outcome is the change in total inflammatory lesion count. Secondary outcomes include changes in acne severity based on the Leeds scale, patient satisfaction, acne severity as perceived by the patient, cost and time-lost to patients and families, need for interim and unexpected urgent appointments, adverse medication effects. The investigators are hypothesizing that patients randomized to the treatment arm will have no statistically significant difference in total inflammatory lesion count or acne severity than the control arm. The investigators also hypothesize that adverse events will be equivalent in both groups and the treatment arm will report less cost associated with visits.","other_id":"2018P001749","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":16,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients must have a diagnosis of severe acne by a dermatologist with a plan of\r\n             initiating treatment with isotretinoin\r\n\r\n          -  Patients must first be enrolled in iPledge prior to eligibility\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who have baseline hepatic dysfunction or hypertriglyceridemia\r\n\r\n          -  Patients with a history of depression, suicide attempts or suicidal ideation\r\n\r\n          -  Patients without access to internet or a camera (including portable camera and/or\r\n             smart phone) at home\r\n\r\n          -  Patients who are pregnant - absolute contraindication\r\n      ","sponsor":"Massachusetts General Hospital","sponsor_type":"Other","conditions":"Acne Vulgaris","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Teledermatology visits","description":"Patients in the treatment arm will be taught by study staff how to take the standardized photos of themselves at treatment week 4 (prior to initiation of teledermatology visits). For patients in the treatment arm, the teledermatology visits will be managed by the study staff. A monthly teledermatology visit will consist of sending facial and truncal (if affected) clinical images to a the study staff using Patient Gateway. Once this is completed, the patient and a member of the study staff will have a scheduled telephone appointment during which the provider will screen for any adverse events and will provide counseling as outlined in iPledge guidelines. The patient will also be asked to verbally complete a monthly survey assessing acne severity, quality of life, cost attributable to the appointment, time missed from school/work, satisfaction with treatment. All photographs will be uploaded in LMR/EPIC in the patient's medical record."}],"outcomes":[{"outcome_type":"primary","measure":"Change in total inflammatory lesion count","time_frame":"Up to 24 weeks","description":"Lesion counting involves counting the number of inflammatory lesions on the face, chest, or back. This excludes comedonal acne."},{"outcome_type":"secondary","measure":"Changes in acne severity","time_frame":"Up to 24 weeks","description":"The Leeds scale will be used to assess patients' acne, which examines the extent of inflammation, range and size of inflamed lesions, and associated erythema. The Leeds technique is a counting system for detailed work in therapeutic trials. A scale of 0 (no acne) to 10 (most severe) is used for grading."},{"outcome_type":"secondary","measure":"Patient satisfaction","time_frame":"Up to 24 weeks","description":"This will be assessed by having the patient fill out a survey about how much time they missed and costs they may have incurred to go to the appointment. They will also be asked questions about how they feel their acne has affected their lives."}]}
{"nct_id":"NCT03716999","start_date":"2021-02-15","enrollment":100,"brief_title":"Starlight Therapy in Palliative Care","official_title":"Starlight Therapy as a Non-Pharmacological Nursing Intervention in Palliative Care","primary_completion_date":"2022-11-30","study_type":"Observational [Patient Registry]","rec_status":"Not yet recruiting","completion_date":"2023-11-30","last_update":"2021-02-01","description":"Starlight Therapy has been shown to help alleviate end-of-life symptoms in Palliative Care patients and reduce the need for PRN or \"as needed\" medications. This study will investigate the efficacy of this intervention using a mixed-method analysis.","other_id":"Starlight Trial","observational_model":"Other","time_perspective":"Other","sampling_method":"Non-Probability Sample","gender":"All","population":"Patients in an inpatient palliative care Setting who meet the specified criteria for\r\n        inclusion in the study","criteria":"\n        Inclusion Criteria:\r\n\r\n        1. ESAS indicates at least one of the following symptoms:\r\n\r\n          -  Insomnia\r\n\r\n          -  Anxiety\r\n\r\n          -  Restlessness\r\n\r\n          -  Dyspnea\r\n\r\n          -  Pain\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Clinical Diagnosis of blindness\r\n\r\n          2. ESAS does not include any of the flowing symptoms:\r\n\r\n               -  Insomnia\r\n\r\n               -  Anxiety\r\n\r\n               -  Restlessness\r\n\r\n               -  Dyspnea\r\n\r\n               -  Pain\r\n      ","sponsor":"Nova Scotia Health Authority","sponsor_type":"Other","conditions":"Symptom Management","interventions":[{"intervention_type":"Other","name":"Other: Starlight Therapy","description":"Starlight Projector will be placed in patients' rooms and project starlight on the ceilings and walls in an effort to reduce unpleasant symptoms"}],"outcomes":[{"outcome_type":"primary","measure":"Using Starlight Therapy to measure Change in Unpleasant Symptoms in Palliative Care Patients as measured using the ESAS (Edmonton Symptom Assessment System) Scale. On a scale of 0-10, with 0 = no symptom and 10= symptom is worst outcome possible.","time_frame":"2 hours of Starlight Therapy","description":"Edmonton Assessment scale questionnaire will be completed before Starlight Therapy and after 2 hours."}]}
{"nct_id":"NCT04735744","start_date":"2021-02-15","enrollment":1315,"brief_title":"Evaluation of Allied Healthcare in Patients Recovering From COVID-19","official_title":"Evaluation of Allied Healthcare in Patients Recovering From COVID-19","primary_completion_date":"2022-07-17","study_type":"Observational","rec_status":"Not yet recruiting","completion_date":"2024-01-01","last_update":"2021-02-03","description":"SUMMARY Rationale: Allied health professionals (i.e., dietitians, exercise therapists, physical therapists, occupational therapists and speech and language therapists) might play an important role in the recovery of patients with COVID-19 who experience limitations in daily physical functioning and participation. However, the evidence base for allied healthcare in patients with COVID-19 has yet to be established. To facilitate care for people recovering from COVID-19 and to establish this evidence base, the Dutch ministry has created a temporary regulation for primary care allied healthcare specifically for patients with COVID-19. Objective: This study is setup alongside the temporary regulation and aims to evaluate the longitudinal recovery trajectories and related costs of patients who visited a primary care allied healthcare professional for the management of severe symptoms and activity limitations and/or participation restrictions related to COVID-19. Study design: Prospective cohort study. Study population: 1,315 adult patients recovering from COVID-19 with severe symptoms and activity limitations and/or participation restrictions, and who are referred to a primary care allied health professional by a general practitioner or medical specialist within four months of the start of the disease will be eligible for this study. Intervention (if applicable): Although the nature of this study is non-experimental, the allied healthcare intervention can be considered experimental due to the novelty of the disease. Main study parameters/endpoints: The primary outcome domain of this study is participation measured with the Utrechtse Schaal voor Revalidatie - Participatie (USER-P). The primary endpoint is set at 6 months. A 5 point difference will be considered clinically relevant for patients with COVID-19. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are no specific risks involved with participation in this study, as it entails the completion of questionnaires over the timeframe of one year (at the start of the treatment, the end of the treatment, 3 months, 6 months, 9 months and 12 months). The load of the survey will be highest at months 3, 6 and 12 with a total of 74 survey items. Input from patient representatives suggested that this number of items was feasible, especially because participants are allowed to complete the survey over a number of days. Finally, none of the items in the survey are considered emotionally distressing. The prescribed interventions are conform the recommendations of the best available evidence and are in line with usual allied healthcare interventions. Therefore, risks are likely to be negligible conform usual allied healthcare.","other_id":"ParaCOV","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"Adult patients of 18 year and older recovering from COVID-19 with severe symptoms and\r\n        activity limitations and/or participation restrictions, who are referred to a primary care\r\n        allied health professional* by a general practitioner or medical specialist are deemed\r\n        eligible for this study.\r\n\r\n        *Allied health professionals relevant to this study are: Dietitians, Exercise Therapists,\r\n        Occupational Therapists, Physical Therapists, and Speech and Language Therapists working in\r\n        primary care in the Netherlands.","criteria":"\n        Inclusion Criteria:\r\n\r\n        Adult patients\r\n\r\n          -  recovering from COVID-19 with severe symptoms and activity limitations and/or\r\n             participation restrictions, and;\r\n\r\n          -  who are referred to a primary care allied health professional by a general\r\n             practitioner or medical specialist within four months of the start of the disease;\r\n             will be eligible for this study. The need for referring the patient to an allied\r\n             health professional will be judged by the primary care physician or medical\r\n             specialist. Criteria for referral are described in guidance published by the Long\r\n             Alliantie Nederland (LAN) with recommendations for treatment of\r\n             post-COVID-19-patients: the COVID-19 Associated Syndrome (CAS) (Chapters 3.3 and 4).\r\n\r\n        http://www.longalliantie.nl/files/2515/9359/4621/Handreiking_voor_de_zorg.pdf\r\n\r\n        Exclusion Criteria:\r\n\r\n        Adult patients:\r\n\r\n        - receiving palliative care; are excluded from this study.\r\n      ","sponsor":"Radboud University","sponsor_type":"Other","conditions":"Covid19|Allied Health Professionals|Primary Care|Retrospective Cohort|PROMs|Performance Measures|Prospective Cohort|National Dutch Program","interventions":[{"intervention_type":"Other","name":"Other: Patients recovering from COVID19 receive usual care by allied health professionals","description":"We will not develop specific interventions for this prospective observational cohort study. The care provided by allied health professionals in daily practice are based on recommendations published by the professional bodies of allied health professionals and on the interdisciplinary guidance developed by the LAN. All allied health professionals are working according to these recommendations. Dissemination of these recommendations is done by the professional bodies of the allied health professionals. Given the observational nature of our study, no additional implementation strategies will be employed to stimulate this care by the research group."}],"outcomes":[{"outcome_type":"secondary","measure":"Liquid medical nutrition","time_frame":"baseline (T0) as part of usual care"},{"outcome_type":"secondary","measure":"Liquid medical nutrition","time_frame":"end of the treatment as part of usual care (average of 6 months)"},{"outcome_type":"secondary","measure":"Sarcopenia","time_frame":"baseline (T0) as part of usual care","description":"measured with the SARC-F"},{"outcome_type":"secondary","measure":"Dietary goal attainment","time_frame":"baseline (T0) as part of usual care"},{"outcome_type":"secondary","measure":"Dietary goal attainment","time_frame":"end of the treatment as part of usual care (average of 6 months)"},{"outcome_type":"primary","measure":"Participation","time_frame":"Baseline (T0)","description":"Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)"},{"outcome_type":"primary","measure":"Participation","time_frame":"3 months (T1)","description":"Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)"},{"outcome_type":"primary","measure":"Participation","time_frame":"6 months (T2)","description":"Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)"},{"outcome_type":"primary","measure":"Participation","time_frame":"12 months (T3)","description":"Measured with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) (32 items)"},{"outcome_type":"primary","measure":"Quality of life measured with EQ-5D-5L","time_frame":"Baseline (T0)","description":"Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)"},{"outcome_type":"primary","measure":"Quality of life measured with EQ-5D-5L","time_frame":"3 months (T1)","description":"Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)"},{"outcome_type":"primary","measure":"Quality of life measured with EQ-5D-5L","time_frame":"6 months (T2)","description":"Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)"},{"outcome_type":"primary","measure":"Quality of life measured with EQ-5D-5L","time_frame":"12 months (T3)","description":"Measured with the EuroQol five-dimensional questionnaire (EQ-5D-5L) (5 items)"},{"outcome_type":"primary","measure":"Fatigue","time_frame":"Baseline (T0)","description":"Measured with the Fatigue Severity Scale (FSS)"},{"outcome_type":"primary","measure":"Fatigue","time_frame":"3 months (T1)","description":"Measured with the Fatigue Severity Scale (FSS)"},{"outcome_type":"primary","measure":"Fatigue","time_frame":"6 months (T2)","description":"Measured with the Fatigue Severity Scale (FSS)"},{"outcome_type":"primary","measure":"Fatigue","time_frame":"12 months (T3)","description":"Measured with the Fatigue Severity Scale (FSS)"},{"outcome_type":"primary","measure":"Physical functioning","time_frame":"Baseline (T0)","description":"PROMIS Physical Functioning Short Form 10b (10 items)."},{"outcome_type":"primary","measure":"Physical functioning","time_frame":"3 months (T1)","description":"PROMIS Physical Functioning Short Form 10b (10 items)."},{"outcome_type":"primary","measure":"Physical functioning","time_frame":"6 months (T2)","description":"PROMIS Physical Functioning Short Form 10b (10 items)."},{"outcome_type":"primary","measure":"Physical functioning","time_frame":"12 months (T3)","description":"PROMIS Physical Functioning Short Form 10b (10 items)."},{"outcome_type":"primary","measure":"Costs","time_frame":"Baseline (T0)","description":"will be measured using a cost questionnaire (18 items)"},{"outcome_type":"primary","measure":"Costs","time_frame":"3 months (T1)","description":"will be measured using a cost questionnaire (18 items)"},{"outcome_type":"primary","measure":"Costs","time_frame":"6 months (T2)","description":"will be measured using a cost questionnaire (18 items)"},{"outcome_type":"primary","measure":"Costs","time_frame":"9 months (T3)","description":"will be measured using a cost questionnaire (18 items)"},{"outcome_type":"primary","measure":"Costs","time_frame":"12 months (T4)","description":"will be measured using a cost questionnaire (18 items)"},{"outcome_type":"primary","measure":"Patient Specific Activities","time_frame":"baseline (T0) as part of usual care","description":"measured with the Patient Specific Complaints (PSC)"},{"outcome_type":"primary","measure":"Patient Specific Activities","time_frame":"end of the treatment as part of usual care (average of 6 months)","description":"measured with the Patient Specific Complaints (PSC)"},{"outcome_type":"primary","measure":"Nutritional Status","time_frame":"baseline (T0) as part of usual care","description":"measured with the BMI (weight and height)"},{"outcome_type":"primary","measure":"Nutritional Status","time_frame":"end of the treatment as part of usual care (average of 6 months)","description":"measured with the BMI (weight and height)"},{"outcome_type":"primary","measure":"Global Assessment","time_frame":"baseline (T0) as part of usual care","description":"measured with the PG-SGA short form weight history, food intake, symptoms, activities and function)."},{"outcome_type":"primary","measure":"Global Assessment","time_frame":"end of the treatment as part of usual care (average of 6 months)","description":"measured with the PG-SGA short form weight history, food intake, symptoms, activities and function)."},{"outcome_type":"primary","measure":"Voice Problems","time_frame":"baseline (T0) as part of usual care","description":"measured with Voice Handicap Index (VHI)"},{"outcome_type":"primary","measure":"Voice Problems","time_frame":"end of the treatment as part of usual care (average of 6 months)","description":"measured with Voice Handicap Index (VHI)"},{"outcome_type":"primary","measure":"Swallowing Problems","time_frame":"baseline (T0) as part of usual care","description":"Dysphagia Handicap Index (DHI)."},{"outcome_type":"primary","measure":"Swallowing Problems","time_frame":"end of the treatment as part of usual care (average of 6 months)","description":"Dysphagia Handicap Index (DHI)."},{"outcome_type":"primary","measure":"Patient Specific Activities","time_frame":"baseline (T0) as part of usual care","description":"measured with the Canadian Occupational Performance Measure (COPM)"},{"outcome_type":"primary","measure":"Patient Specific Activities","time_frame":"end of the treatment as part of usual care (average of 6 months)","description":"measured with the Canadian Occupational Performance Measure (COPM)"},{"outcome_type":"primary","measure":"Activities","time_frame":"baseline (T0) as part of usual care","description":"measured with the PRO-ergo"},{"outcome_type":"primary","measure":"Activities","time_frame":"end of the treatment as part of usual care (average of 6 months)","description":"measured with the PRO-ergo"},{"outcome_type":"secondary","measure":"Exercise capacity","time_frame":"baseline (T0) as part of usual care","description":"6 Minute Walk Test (6MWT)"},{"outcome_type":"secondary","measure":"Exercise capacity","time_frame":"end of the treatment as part of usual care (average of 6 months)","description":"6 Minute Walk Test (6MWT)"},{"outcome_type":"secondary","measure":"Exercise capacity","time_frame":"baseline (T0) as part of usual care","description":"Short Physical Performance Battery (SPPB)"},{"outcome_type":"secondary","measure":"Exercise capacity","time_frame":"end of the treatment as part of usual care (average of 6 months)","description":"Short Physical Performance Battery (SPPB)"},{"outcome_type":"secondary","measure":"Quadriceps strength","time_frame":"baseline (T0) as part of usual care","description":"with a hand dynamometer."},{"outcome_type":"secondary","measure":"Quadriceps strength","time_frame":"end of the treatment as part of usual care (average of 6 months)","description":"with a hand dynamometer."},{"outcome_type":"secondary","measure":"Hand grip strength","time_frame":"baseline (T0) as part of usual care","description":"with a hand dynamometer."},{"outcome_type":"secondary","measure":"Hand grip strength","time_frame":"end of the treatment as part of usual care (average of 6 months)","description":"with a hand dynamometer."},{"outcome_type":"secondary","measure":"Bioimpedance (BIA","time_frame":"baseline (T0) as part of usual care"},{"outcome_type":"secondary","measure":"Bioimpedance (BIA","time_frame":"end of the treatment as part of usual care (average of 6 months)"},{"outcome_type":"secondary","measure":"VAS-appetite, taste and smell","time_frame":"baseline (T0) as part of usual care"},{"outcome_type":"secondary","measure":"VAS-appetite, taste and smell","time_frame":"end of the treatment as part of usual care (average of 6 months)"},{"outcome_type":"secondary","measure":"Sarcopenia","time_frame":"end of the treatment as part of usual care (average of 6 months)","description":"measured with the SARC-F"},{"outcome_type":"secondary","measure":"Types of Stool","time_frame":"baseline (T0) as part of usual care","description":"measured with the Bristol Stool Chart (BCS)"},{"outcome_type":"secondary","measure":"Types of Stool","time_frame":"end of the treatment as part of usual care (average of 6 months)","description":"measured with the Bristol Stool Chart (BCS)"},{"outcome_type":"secondary","measure":"Voice Problems","time_frame":"baseline (T0) as part of usual care","description":"measured with Maximum Phonation Time (MPT)"},{"outcome_type":"secondary","measure":"Voice Problems","time_frame":"end of the treatment as part of usual care (average of 6 months)","description":"measured with Maximum Phonation Time (MPT)"},{"outcome_type":"secondary","measure":"Swallowing Problems","time_frame":"baseline (T0) as part of usual care","description":"measured with Maximum Swallowing Speed (MSP)"},{"outcome_type":"secondary","measure":"Swallowing Problems","time_frame":"end of the treatment as part of usual care (average of 6 months)","description":"measured with Maximum Swallowing Speed (MSP)"},{"outcome_type":"secondary","measure":"Physical Functioning","time_frame":"baseline (T0) as part of usual care","description":"measured with the Assessment of Motor and Process Skills (AMPS)"},{"outcome_type":"secondary","measure":"Physical Functioning","time_frame":"end of the treatment as part of usual care (average of 6 months)","description":"measured with the Assessment of Motor and Process Skills (AMPS)"},{"outcome_type":"secondary","measure":"Cognitive Functioning","time_frame":"baseline (T0) as part of usual care","description":"measured with the Cognitive Complaints - Participation (CoCo-P)"},{"outcome_type":"secondary","measure":"Cognitive Functioning","time_frame":"end of the treatment as part of usual care (average of 6 months)","description":"measured with the Cognitive Complaints - Participation (CoCo-P)"}]}
{"nct_id":"NCT04756531","start_date":"2021-02-11","phase":"Phase 1","enrollment":78,"brief_title":"STUDY OF PF-07321332 IN HEALTHY PARTICIPANTS","official_title":"A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO CONTROLLED, SINGLE- AND MULTIPLE-DOSE ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF PF 07321332 IN HEALTHY ADULT PARTICIPANTS","primary_completion_date":"2021-09-02","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-09-02","last_update":"2021-07-02","description":"A Phase 1, double blind, sponsor open, single and multiple ascending dose study to evaluate safety, tolerability and pharmacokinetics of PF-07321332 in healthy participants.","other_id":"C4671001","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Other","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy male or female subjects between ages of 18-60 years\r\n\r\n          -  Body Mass Index (BMI) of 17.5 to 30.5kg/m2; and a total body weight >50kg (110lbs)\r\n\r\n          -  (Optional) Japanese subjects who have four Japanese biologic grandparents born in\r\n             Japan\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Evidence or history of clinically significant hematological, renal, endocrine,\r\n             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or\r\n             allergic disease (including drug allergies, but excluding untreated, asymptomatic,\r\n             seasonal allergies at time of dosing)\r\n\r\n          -  Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy,\r\n             intestinal resection).\r\n\r\n          -  Positive test result for SARS-CoV-2 infection at the time of screening or Day-1.\r\n\r\n          -  Have received COVID-19 vaccine within 7 days before screening or have received only\r\n             one of the 2 required doses of COVID-19 vaccine\r\n\r\n          -  Use of tobacco or nicotine containing products in excess of the equivalents of 5\r\n             cigarettes per day or 2 chews of tobacco per day\r\n      ","sponsor":"Pfizer","sponsor_type":"Industry","conditions":"Healthy Participants","interventions":[{"intervention_type":"Drug","name":"Drug: PF-07321332 Dose 1","description":"PF-07321332 Dose 1"},{"intervention_type":"Drug","name":"Drug: PF-07321332 Dose 2","description":"PF-07321332 Dose 2"},{"intervention_type":"Drug","name":"Drug: PF-07321332 Dose 3","description":"PF-07321332 Dose 3"},{"intervention_type":"Drug","name":"Drug: PF-07321332 Dose 4","description":"PF-07321332 Dose 4"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"Number of participants with Treatment Emergent Adverse Events (TEAEs) in single ascending dose (SAD)","time_frame":"Day 1 to Day 4","description":"An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) is defined as any untoward medical occurrence at any dose that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect. AEs include both SAEs and AEs. TEAEs are AEs that occur following the start of treatment or AEs increasing in severity during treatment"},{"outcome_type":"primary","measure":"Number of Participants With Clinically Significant Change From Baseline in Vital Signs in SAD","time_frame":"Day 1 to Day 4"},{"outcome_type":"primary","measure":"Number of Participants With Laboratory Abnormalities in SAD","time_frame":"Day 1 to Day 4"},{"outcome_type":"primary","measure":"Number of Participants with Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings in SAD","time_frame":"Day 1 to Day 4","description":"Criteria for clinically significant changes in ECG (12-lead) are defined as: a postdose QTc interval increase by ≥30 msec from the baseline and is >450 msec; or an absolute QTc value is ≥500 msec for any scheduled ECG"},{"outcome_type":"primary","measure":"Number of participants with TEAEs in multiple ascending dose (MAD)","time_frame":"Day 1 to Day 12","description":"An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence at any dose that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect. AEs include both SAEs and AEs. TEAEs are AEs that occur following the start of treatment or AEs increasing in severity during treatment"},{"outcome_type":"primary","measure":"Number of Participants With Clinically Significant Change From Baseline in Vital Signs in MAD","time_frame":"Day 1 to Day 12","description":"Vital signs evaluation includes: supine systolic and diastolic blood pressure (BP), temperature, respiratory rate and pulse rate."},{"outcome_type":"primary","measure":"Number of Participants With Laboratory Abnormalities in MAD","time_frame":"Day 1 to Day 12"},{"outcome_type":"primary","measure":"Number of Participants with Clinically Significant Change From Baseline in ECGs Findings in MAD","time_frame":"Day 1 to Day 12","description":"Criteria for clinically significant changes in ECG (12-lead) are defined as: a postdose QTc interval increase by ≥30 msec from the baseline and is >450 msec; or an absolute QTc value is ≥500 msec for any scheduled ECG"},{"outcome_type":"secondary","measure":"Maximum Plasma Concentration (Cmax) in SAD","time_frame":"Day 1 to Day 4","description":"The maximum observed plasma concentration (Cmax) is estimated based on the plasma concentrations"},{"outcome_type":"secondary","measure":"Dose Normalized Maximum Plasma Concentration (Cmax[dn]) in SAD","time_frame":"Day 1 to Day 4","description":"Cmax(dn) = Cmax / dose."},{"outcome_type":"secondary","measure":"Time for Cmax (Tmax) in SAD","time_frame":"Day 1 to Day 4","description":"Tmax was summarized by dosing regimen. It was observed directly from data as time of first occurrence."},{"outcome_type":"secondary","measure":"Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) in SAD","time_frame":"Day 1 to Day 4","description":"AUClast is summarized by dosing regimen and determined by linear/log trapezoidal method."},{"outcome_type":"secondary","measure":"Dose Normalized Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast[dn]) in SAD","time_frame":"Day 1 to Day 4","description":"AUClast /dose"},{"outcome_type":"secondary","measure":"Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) in SAD","time_frame":"Day 1 to Day 4","description":"AUCinf = Area under the plasma concentration versus time curve (AUC) from time 0 (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf)."},{"outcome_type":"secondary","measure":"Dose Normalized Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf[dn]) in SAD","time_frame":"Day 1 to Day 4","description":"AUClast(dn) = AUClast / dose."},{"outcome_type":"secondary","measure":"Terminal Elimination Half-Life (t½) in SAD","time_frame":"Day 1 to Day 4","description":"t1/2 is summarized by dosing regimen . It is determined by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline is used in the regression."},{"outcome_type":"secondary","measure":"Apparent Clearance (CL/F) in SAD","time_frame":"Day 1 to Day 4","description":"CL/F is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Calculated as Dose/AUCinf. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood."},{"outcome_type":"secondary","measure":"Apparent Volume of Distribution (Vz/F) in SAD","time_frame":"Day 1 to Day 4","description":"Vz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F is influenced by the fraction absorbed."},{"outcome_type":"secondary","measure":"Cmax in MAD-Day 1","time_frame":"Day 1 Pre-dose (0 hours) to 12 hours","description":"Observed Cmax is estimated based on the plasma concentrations"},{"outcome_type":"secondary","measure":"Cmax(dn) in MAD-Day 1","time_frame":"Day 1 Pre-dose (0 hours) to 12 hours","description":"Cmax/dose is summarized by dosing regimen."},{"outcome_type":"secondary","measure":"Cmax in MAD-Day 5","time_frame":"Day 5 Pre-dose (0 hours) to 12 hours","description":"Observed Cmax is estimated based on the plasma concentrations"},{"outcome_type":"secondary","measure":"Dose Normalized Maximum Plasma Concentration (Cmax[dn]) in MAD-Day 5","time_frame":"Day 5 Pre-dose (0 hours) to 12 hours","description":"Cmax/dose is summarized by dosing regimen."},{"outcome_type":"secondary","measure":"Cmax in MAD-Day 10","time_frame":"Day 10 (0h) Pre-dose (0 hours) to 12 hours","description":"Observed Cmax is estimated based on the plasma concentrations"},{"outcome_type":"secondary","measure":"Dose Normalized Maximum Plasma Concentration (Cmax[dn]) in MAD-Day 10","time_frame":"Day 10 Pre-dose (0 hours) to 12 hours","description":"Cmax/dose is summarized by dosing regimen."},{"outcome_type":"secondary","measure":"Time for Cmax (Tmax) in MAD-Day 1","time_frame":"Day 1 Pre-dose (0 hours) to 12 hours","description":"Tmax was summarized by dosing regimen. It was observed directly from data as time of first occurrence."},{"outcome_type":"secondary","measure":"Tmax in MAD-Day 5","time_frame":"Day 5 Pre-dose (0 hours) to 12 hours","description":"Tmax was summarized by dosing regimen. It was observed directly from data as time of first occurrence."},{"outcome_type":"secondary","measure":"Tmax in MAD-Day 10","time_frame":"Day 10 Pre-dose (0 hours) to 12 hours","description":"Tmax was summarized by dosing regimen. It was observed directly from data as time of first occurrence."},{"outcome_type":"secondary","measure":"Area Under the Plasma Concentration-Time Profile From Time Zero To End of Dosing Interval (AUCtau) in MAD-Day 1","time_frame":"Day 1 Pre-dose (0 hours) to 12 hours","description":"AUCtau is summarized by dosing regimen and period. Dosing interval is the interval tau between administration of doses of drug. In this study, the dosing interval is 8 hours for three times daily (TID) dosing and 12 hours for twice daily (BID) dosing. It is determined by linear/log trapezoidal method."},{"outcome_type":"secondary","measure":"Dose Normalized Area Under the Plasma Concentration-Time Profile From Time Zero To End of Dosing Interval (AUCtau[dn]) in MAD-Day 1","time_frame":"Day 1 Pre-dose (0 hours) to 12 hours","description":"AUCtau/dose is summarized by dosing regimen and period. Dosing interval is the interval tau between administration of doses of drug. In this study, the dosing interval is 8 hours for TID dosing and 12 hours for BID dosing. I"},{"outcome_type":"secondary","measure":"AUCtau in MAD-Day 5","time_frame":"Day 5 Pre-dose (0 hours) to 12 hours","description":"AUCtau is summarized by dosing regimen and period. Dosing interval is the interval tau between administration of doses of drug. In this study, the dosing interval is 8 hours for TID dosing and 12 hours for BID dosing. It is determined by linear/log trapezoidal method."},{"outcome_type":"secondary","measure":"AUCtau(dn) in MAD-Day 5","time_frame":"Day 5 Pre-dose (0 hours) to 12 hours","description":"AUCtau/dose is summarized by dosing regimen and period. Dosing interval is the interval tau between administration of doses of drug. In this study, the dosing interval is 8 hours for TID dosing and 12 hours for BID dosing. I"},{"outcome_type":"secondary","measure":"AUCtau in MAD-Day 10","time_frame":"Day 10 Pre-dose (0 hours) to 12 hours","description":"AUCtau is summarized by dosing regimen and period. Dosing interval is the interval tau between administration of doses of drug. In this study, the dosing interval is 8 hours for TID dosing and 12 hours for BID dosing. It is determined by linear/log trapezoidal method."},{"outcome_type":"secondary","measure":"Dose Normalized Area Under the Plasma Concentration-Time Profile From Time Zero To End of Dosing Interval (AUCtau[dn]) in MAD-Day 10","time_frame":"Day 10 Pre-dose (0 hours) to 12 hours","description":"AUCtau/dose is summarized by dosing regimen and period. Dosing interval is the interval tau between administration of doses of drug. In this study, the dosing interval is 8 hours for TID dosing and 12 hours for BID dosing. I"},{"outcome_type":"secondary","measure":"Lowest Concentration Observed During the Dosing Interval tau (Cmin) in MAD-Day 5","time_frame":"Day 5 Pre-dose (0 hours) to 12 hours","description":"Cmin is observed directly from data. It is summarized by dosing regimen. Dosing interval is the interval tau between administration of doses of drug. In this study, the dosing interval tau is 8 hours for TID dosing and 12 hours for BID dosing."},{"outcome_type":"secondary","measure":"Cmin in MAD-Day 10","time_frame":"Day 10 Pre-dose (0 hours) to 12 hours","description":"Cmin is observed directly from data. It is summarized by dosing regimen. Dosing interval is the interval tau between administration of doses of drug. In this study, the dosing interval tau is 8 hours for TID dosing and 12 hours for BID dosing."},{"outcome_type":"secondary","measure":"t½ in MAD-Day 10","time_frame":"Day 10 Pre dose (0 hours) to Day 12 (48 hours post dose)","description":"t1/2 is summarized by dosing regimen . It is determined by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline is used in the regression."},{"outcome_type":"secondary","measure":"Vz/F in MAD-Day 10","time_frame":"Day 10 Pre-dose (0 hours) to 12 hours","description":"Vz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. VZ/F after oral dose is influenced by the fraction absorbed."},{"outcome_type":"secondary","measure":"Peak Trough Ratio (PTR) in MAD-Day 5","time_frame":"Day 5 Pre-dose (0 hours) to 12 hours","description":"PTR = Cmax,ss / Cmin,ss, where ss means 'at steady state'. It is summarized by dosing regimen ."},{"outcome_type":"secondary","measure":"PTR in MAD-Day 10","time_frame":"Day 10 Pre-dose (0 hours) to 12 hours","description":"PTR = Cmax,ss / Cmin,ss, where ss means 'at steady state'. It is summarized by dosing regimen ."},{"outcome_type":"secondary","measure":"Observed Accumulation Ratio Based on AUC (Rac) in MAD-Day 5","time_frame":"Day 5 Pre-dose (0 hours) to 12 hours","description":"Rac = AUCtau,ss / AUCtau,sd, where ss means 'at steady state' and sd 'single dose'. In this study, Rac = AUCtau(Day 5) / AUCtau(Day 1). Rac is summarized by dosing regimen."},{"outcome_type":"secondary","measure":"Rac in MAD-Day 10","time_frame":"Day 10 Pre-dose (0 hours) to 12 hours","description":"Rac = AUCtau,ss / AUCtau,sd, where ss means 'at steady state' and sd 'single dose'. In this study, Rac = AUCtau(Day 10) / AUCtau(Day 1). Rac is summarized by dosing regimen."},{"outcome_type":"secondary","measure":"Observed Accumulation Ratio Based on Cmax (Rac,Cmax) in MAD-Day 5","time_frame":"Day 5 Pre-dose (0 hours) to 12 hours","description":"Rac,Cmax = Cmax,ss / Cmax,sd, where ss means 'at steady state' and sd 'single dose'. In this study, Rac,Cmax = Cmax(Day5) / Cmax(Day 1). Rac,Cmax is summarized by dosing regimen."},{"outcome_type":"secondary","measure":"Rac,Cmax in MAD-Day 10","time_frame":"Day 10 Pre-dose (0 hours) to 12 hours","description":"Rac,Cmax = Cmax,ss / Cmax,sd, where ss means 'at steady state' and sd 'single dose'. In this study, Rac,Cmax = Cmax(Day10) / Cmax(Day 1). Rac,Cmax is summarized by dosing regimen."},{"outcome_type":"secondary","measure":"CL/F in MAD-Day 5","time_frame":"Day 5 Pre-dose (0 hours) to 12 hours","description":"CL/F is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. calculated as Dose/AUC tau. Dosing interval (tau) is 8 h for TID dosing and 12 h for BID dosing."},{"outcome_type":"secondary","measure":"CL/F in MAD-Day 10","time_frame":"Day 10 Pre-dose (0 hours) to 12 hours","description":"CL/F is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. calculated as Dose/AUC tau. Dosing interval (tau) is 8 h for TID dosing and 12 h for BID dosing."},{"outcome_type":"secondary","measure":"Cumulative Amount of Drug Recovered Unchanged in Urine From Time 0 to the Dosing Interval tau Hours Post-Dose (Aetau) in MAD-Day 10","time_frame":"Day 10 Pre-dose (0 hours) to 12 hours","description":"Sum of (urine volume × urine concentration) for each collection over the dosing interval tau. Dosing interval (tau) is 8h for TID and 12 h for BID dosing."},{"outcome_type":"secondary","measure":"Percentage of Dose Recovered Unchanged in Urine From Time 0 to the Dosing Interval tau Hours Post-Dose (Aetau%) in MAD-Day 10","time_frame":"Day 10 Pre-dose (0 hours) to 12 hours","description":"Aetau% = Aetau / Dose * 100. Aetau% is summarized by dosing regimen. Dosing interval (tau) is 8h for TID and 12 h for BID dosing."},{"outcome_type":"secondary","measure":"Renal Clearance (Clr) in MAD-Day 10","time_frame":"Day 10 Pre-dose (0 hours) to 12 hours","description":"Renal clearance is calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Aetau) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau), where dosing interval is 8 hours for TID dosing and 12 hours for BID dosing."}]}
{"nct_id":"NCT04740515","start_date":"2021-02-10","phase":"N/A","enrollment":500,"brief_title":"Influence of a PPMTM on Adherence and Clinical Outcomes Among Preterm Infants With Iron Supplementation","official_title":"Evaluation of the Influence of a Pharmacist-led Patient-Centered Medication Therapy Management on Adherence and Clinical Outcomes Among Preterm Infants With Iron Supplementation","primary_completion_date":"2023-02-09","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2025-02-08","last_update":"2021-02-05","description":"This is a randomised trial on the efficacy of a Pharmacist-led Patient-Centered Medication Therapy Management on clinical outcomes among preterm infants born before 32 weeks gestation with iron supplementation. The purpose of this study is to evaluate clinical outcome in the PPMTM program compared with usual care in an integrated health care system.","other_id":"XRenjie","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":0.5,"maximum_age":0.61538,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  NICU inpatients between 26 and 32 weeks of gestation Infants older than two week of\r\n             age and Iron dosing will be adjusted for weight at weekly intervals to maintain dosing\r\n             at 4mg/kg/day.\r\n\r\n        Parental permission obtained prior to start of study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  In extremis during consent window (as judged by primary attending provider) Known or\r\n             suspected genetic disorder Small for gestational age (birth weight below the 10th\r\n             percentile for gestational age) Unable to return for follow-up evaluation at 6 months\r\n             of age\r\n      ","sponsor":"Shaoxing Maternity and Child Health Care Hospital","sponsor_type":"Other","conditions":"Preterm Infants|Clinical Outcome|Pharmaceutical Care","interventions":[{"intervention_type":"Other","name":"Other: pharmacists involved PPMTM","description":"This was an open labelled randomised study. Preterm Infants With iron supplementation were recruited and arbitrarily divided into the intervention group (usual care plus PPMTM) and the non-intervention group (usual care only). Those enrolled in the research were scheduled for follow-up for eight consecutive visits. Improvements in lab results and direct costs were compared longitudinally (pre and post analysis) between the groups."}],"outcomes":[{"outcome_type":"primary","measure":"reticulocyte hemoglobin equivalent (Ret-He, pg)","time_frame":"At discharge or 40 weeks corrected age (whichever occurs first), Correct gestational age of 3 months and 6 months","description":"Iron insufficiency will be determined by Ret-He less than 27.2 pg"},{"outcome_type":"primary","measure":"ferritin level","time_frame":"At discharge or 40 weeks corrected age (whichever occurs first), Correct gestational age of 3 months and 6 months","description":"Iron insufficiency will be determined by ferritin level less than 70 ng/mL"},{"outcome_type":"primary","measure":"hemoglobin level","time_frame":"At discharge or 40 weeks corrected age (whichever occurs first), Correct gestational age of 3 months and 6 months","description":"Iron insufficiency will be determined by hemoglobin level less than 8 g/dL"},{"outcome_type":"primary","measure":"reticulocyte count (%)","time_frame":"At discharge or 40 weeks corrected age (whichever occurs first), Correct gestational age of 3 months and 6 months","description":"Iron insufficiency will be determined by reticulocyte count less than 2%"}]}
{"nct_id":"NCT04906772","start_date":"2021-02-03","phase":"Phase 4","enrollment":70,"brief_title":"Dexmedetomidine-ketamine Versus Propofol-ketamine for Sedation During Endoscopy in Hepatic Patients","official_title":"Dexmedetomidine-ketamine Versus Propofol-ketamine for Sedation During Upper Gastro-intestinal Endoscopy in Hepatic Patients (a Comparative Randomized Study)","primary_completion_date":"2021-07-13","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2021-07-30","last_update":"2021-05-28","description":"We aim to compare the response to ketamine/dexmedetomidine and ketamine/propofol combinations used in hepatic patients with child-Pugh classification (class A), and early (class B) undergoing UGIE.","other_id":"FAMSU R 21","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  hepatic patients with child-Pugh classification (class A), and (class B)\r\n\r\n          -  American Society of Anesthesiologists physical status II, III\r\n\r\n          -  aged 18 to 60 years\r\n\r\n          -  scheduled for elective Upper gastro-intestinal endoscopy.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  emergency gastro-intestinal endoscopy.\r\n\r\n          -  patients with severe hepatic disorder (Child C) ,\r\n\r\n          -  chronic neuro-psychiatric disorder,\r\n\r\n          -  history of neuro-psychiatric drug intake,\r\n\r\n          -  severe cardiovascular diseases,\r\n\r\n          -  pregnancy,\r\n\r\n          -  history of drug abuse, and\r\n\r\n          -  history of allergy to any of the used drugs in the study\r\n      ","sponsor":"Tamer Nabil Abdelrahman","sponsor_type":"Other","conditions":"Anesthesia; Reaction","interventions":[{"intervention_type":"Drug","name":"Drug: Dexmedetomidine","description":"participants received loading of ketamine 1 mg/kg and dexmedetomidine 1g/kg over 10 minutes then continue by a dose of 0.25 mg/kg/hr ketamine and 0.25g/kg/hr dexmedetomidine throughout the procedure."},{"intervention_type":"Drug","name":"Drug: Propofol","description":"participants received loading of ketamine 1 mg/kg and propofol 1mg/kg over 10 minutes then continue by a dose of 0.25 mg/kg/hr propofol and 0.25g/kg/hr dexmedetomidine throughout the procedure."}],"outcomes":[{"outcome_type":"primary","measure":"induction time","time_frame":"after 5 minutes from the start of drug infusion till target Ramsay Sedation Score ≥ 3 is reached","description":"Time to reach target Ramsay Sedation Score ≥ 3"},{"outcome_type":"primary","measure":"Recovery time","time_frame":"after 10 minutes from the stoppage of drug infusion at the end of the procedure till spontaneous eye opening","description":"time from the stoppage of drug infusion at the end of the procedure till spontaneous eye opening"}]}
{"nct_id":"NCT03061435","start_date":"2021-02-01","phase":"N/A","enrollment":110,"brief_title":"Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer.","official_title":"Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer.","primary_completion_date":"2022-02-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-02-01","last_update":"2021-05-12","description":"Almost half of all women will develop an HPV infection in their lifetime. While most infections are naturally asymptomatic or cleared by the immune system, some persist and can lead to the development of cervical, vulvar, or anal lesions and eventually cancer. Screening regimens for these lesions are currently only in place for the cervix through regular Pap tests. These Pap tests usually involve an examination of the vulva -however, no screening procedures exist for anal cancer for women. Several studies have suggested that women with existing gynecological lesions are more likely to develop anal lesions and anal cancer. Here the investigators propose a multi-center study which seeks to screen for and treat anal cancer in women over the age of 40 with vulvar lesions and a stable immune system. The investigators will achieve this through performing anal Pap smears on eligible women and conducting High Resolution Anoscopy (HRA) and appropriate treatment procedures on those with abnormal anal cells. With enough evidence, there may be an indication to establish regular anal cancer screening measures in this potentially underserved population. Hypothesis: The investigators hypothesize that at least 40% of women with vulvar cancer or VIN2/3 will have abnormal anal cytology. 35% of the population will be hrHPV DNA positive and 11% will additionally have AIN2/3. This prospective study may lay the groundwork for routine anal screening regimens in Ontario and help shift health policy to treat this population.","other_id":"GYNEOCC 3","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Screening","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Women age  40\r\n\r\n          -  Previous diagnosis of VIN 2/3 or vulvar\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Women with a previous diagnosis of cancer aside from basal cell carcinoma of the skin,\r\n             cervical cancer, or vulvar cancer\r\n\r\n          -  Women who are HIV positive\r\n\r\n          -  Women currently taking immunosuppressant medication\r\n\r\n          -  Women who have had a previous hysterectomy\r\n      ","sponsor":"Dr. Danielle Vicus","sponsor_type":"Other","conditions":"Vulvar Cancer|Cervical Cancer|Vulvar Dysplasia|Cervical Dysplasia|Anal Cancer|Anal Dysplasia|HPV-Related Anal Squamous Cell Carcinoma","interventions":[{"intervention_type":"Procedure","name":"Procedure: Screening anal Pap smear - No high-resolution anoscopy","description":"75% of patients with negative cytology on their anal Pap smear will not receive high-resolution anoscopy"},{"intervention_type":"Procedure","name":"Procedure: Screening anal Pap smear - High-resolution anoscopy","description":"25% of patients with negative cytology on their anal Pap smear will receive high-resolution anoscopy. All patients with positive (abnormal) cytology on their anal Pap smear will receive high-resolution anoscopy."}],"outcomes":[{"outcome_type":"primary","measure":"Prevalence of abnormal anal cytology and hrHPV DNA in women with VIN 2/3 or vulvar cancer","time_frame":"6 months to 1 year"},{"outcome_type":"secondary","measure":"Prevalence of AIN in women with VIN 2/3 or vulvar cancer","time_frame":"6 months to 1 year"},{"outcome_type":"secondary","measure":"Assess t he correlation between abnormal anal cytology, hrHPV DNA, and AIN","time_frame":"6 months to 1 year"}]}
{"nct_id":"NCT04724759","start_date":"2021-02-01","phase":"Phase 2","enrollment":60,"brief_title":"The Effect of Opioid-Free Anesthesia in TMJ Surgery","official_title":"The Effect of Opioid-Free Anesthesia in TMJ Surgery: A Prospective Study","primary_completion_date":"2022-12-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2023-07-31","last_update":"2021-01-26","description":"This study aims is to evaluate the effect of opioid free total intravenous anesthesia on postoperative quality of recovery in patients undergoing oral and maxillofacial surgery (OMF) temporomandibular joint (TMJ) surgery.","other_id":"2020P003873","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients aged 18 to 75 (inclusive)\r\n\r\n          -  Scheduled for TMJ surgery (including both unilateral and bilateral procedures)\r\n\r\n          -  Planned arthroscopic surgical procedure\r\n\r\n          -  Preoperative plan to discharge the same day\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Inability to provide written informed consent\r\n\r\n          -  Pregnant patients\r\n\r\n          -  Open TMJ Surgeries\r\n\r\n          -  Planned overnight admission\r\n\r\n          -  Mental status disorder or patient who are unable to communicate\r\n      ","sponsor":"Massachusetts General Hospital","sponsor_type":"Other","conditions":"Temporomandibular Joint Disorders","interventions":[{"intervention_type":"Drug","name":"Drug: Dexmedetomidine / Ketamine / Lidocaine","description":"Patients in this group will receive an infusion of lidocaine, ketamine, or dexmedetomidine supplemented with other intravenous analgesics and intravenous and inhaled anesthetics, as needed clinically. This includes administration of 5 mcg/kg/min of ketamine plus 0.5 - 1.0 g/kg/hr of dexmedetomidine (Precedex) as a continuous infusion, started from induction to stop one hour before surgery is anticipated to end."}],"outcomes":[{"outcome_type":"primary","measure":"Pain Score","time_frame":"Through in-hospital study completion, an average of 1 day","description":"Pain will be measured using the eleven point (0 to 10) numeric rating scale. Pain scores will be recorded every 15 minutes until discharge from the post-anesthesia care unit (PACU) and at 12 and 24 hours postoperatively. Clinically documented pain scores will be recorded. Our primary outcome will be the worst documented pain score while in the PACU. Additional pain score time points will be evaluated as secondary endpoints."},{"outcome_type":"secondary","measure":"Perioperative Opioid Use","time_frame":"48 hours postoperatively","description":"Intraoperative and postoperative opioid consumption in the first 12, 24 and 48 hours postoperatively will be evaluated."},{"outcome_type":"secondary","measure":"Rescue Analgesia in the PACU","time_frame":"Through in-hospital study completion, an average of 1 day","description":"Use, dosage and time to use of rescue analgesia in the PACU will be reported."},{"outcome_type":"secondary","measure":"Pain Satisfaction","time_frame":"Through in-hospital study completion, an average of 1 day","description":"Self-report pain satisfaction will be assessed at the time of PACU discharge using the Revised American Pain Society Patient Outcome Questionnaire."},{"outcome_type":"secondary","measure":"Incidence of Opioid Related Adverse Effects","time_frame":"48 hours postoperatively","description":"The incidence of ileus, nausea/vomiting, and pruritis will be reported."},{"outcome_type":"secondary","measure":"Length of Stay","time_frame":"Through in-hospital study completion, an average of 1 day","description":"Length of PACU and hospital stay will be reported."},{"outcome_type":"secondary","measure":"Percocet Use","time_frame":"48 hours postoperatively","description":"The total dose of Percocet used at 24 and 48 hours after surgery will be reported."}]}
{"nct_id":"NCT04511182","start_date":"2021-02-01","phase":"N/A","enrollment":160,"brief_title":"Early Individualized-Exercise Based Cardiac Rehabilitation Programs in Patients With Acute Myocardial Infarction","official_title":"Early Individualized-exercise Based Cardiac Rehabilitation Program in Patients With a Recent Acute Myocardial Infarction (EARLYmyo-CRP): Study Protocol for a Randomised Controlled Trial","primary_completion_date":"2022-08-01","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2023-02-01","last_update":"2021-02-05","description":"Acute myocardial infarction (AMI) is a life-threatening condition and a cause of functional disability. After reperfusion therapies and pharmacological strategies, patients suffered great pain physically and mentally. How to improve the quality of life and the prognosis in patients with AMI is a hot topic in the field of cardiac rehabilitation now. In this study, a randomized, controlled and prospective clinical trial is designed for patients with AMI to improve exercise capacity, cardiometabolic parameters, as well as quality of life by an individualized, low-cost exercise intervention we developed after evaluation by Cardiopulmonary Exercise Tests (CPET). Serial CPET are performed to prospectively measure changes in aerobic exercise capacity, and the MOS item short form health surveySF-36are constructed to survey life quality. What's more, echocardiography and NT-proBNP are also assessed.","other_id":"CRP2","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion criteria\r\n\r\n          1. Acute myocardial infarction (AMI) within 1 months prior to recruitment.\r\n\r\n          2. Complete revascularization.\r\n\r\n          3. Man or non- pregnant women aged from 18 to 80 years.\r\n\r\n        Exclusion criteria\r\n\r\n          1. Uncontrolled hypertension (systolic blood pressure/diastolic blood pressure >160/100\r\n             mmHg)or symptomatic hypotension.\r\n\r\n          2. Significant resting electrocardiogram abnormalities (left bundle branch block,\r\n             non-specific intraventricular conduction delay, left ventricular hypertrophy, resting\r\n             ST-segment depression), life-threatening cardiac arrhythmias.\r\n\r\n          3. Acute myocarditis, pericarditis or acute systemic illness.\r\n\r\n          4. Those who are assessed by the doctor as high-risk [12].\r\n\r\n          5. Pacemaker or implantable cardioverter defibrillator.\r\n\r\n          6. Any contraindication to exercise testing or exercise training or inability to complete\r\n             a CPET.\r\n\r\n          7. Life-threatening diseases with limited life expectancy <3 year.\r\n\r\n          8. Uncontrolled unstable angina pectoris.\r\n\r\n          9. Significant valvular disease (mitral stenosis, moderate to severe mitral\r\n             insufficiency, aortic stenosis, or aortic insufficiency, severe mitral / aortic\r\n             regurgitation).\r\n\r\n         10. Severe mental or cognitive impairment.\r\n\r\n         11. Inability to follow the procedures of the study.\r\n      ","sponsor":"RenJi Hospital","sponsor_type":"Other","conditions":"Acute Myocardial Infarction","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Exercise-based cardiac rehabilitation","description":"Exercise program is based on aerobic exercise and supplemented by strength training following the principle of gradual improvement. The type of exercise, such as walking, jogging, cycling, and the intensity of exercise which is recommended to use a cardiotach or pedometer to detect, are both defined by the results of CPET, such as METs value. Participators must be prepared for about 5-10 minutes to warm up and recover before and after exercise. 30-50 minutes a day, 5 days a week, with a total exercise time of not less than 150 minutes per week. It can be carried out in different stages according to the physical condition. After 1-3 months, the exercise prescription will be re-adjusted according to the results of reexamination.\r\nAll patients will undergo Cardiopulmonary Exercise Test, SF-36, echocardiography and laboratory examination prior to initiation of the trial, and which will be checked again after 3 months, and 6 months."}],"outcomes":[{"outcome_type":"secondary","measure":"The occurrence and composite of major adverse cardiac events (MACE)","time_frame":"3, 6 months","description":"Major adverse cardiac events (MACE) included all-cause mortality, non-fatal myocardial infarction and coronary revascularisation. we check the outcome in 3 months and 6 months."},{"outcome_type":"secondary","measure":"Ventilatory efficiency (VE/VCO2 slope) change","time_frame":"Baseline, 3, 6 months","description":"Difference in the interval changes from baseline to 3 months and 6 months in Ventilatory efficiency (VE/VCO2 slope) comparing experimental group with control."},{"outcome_type":"primary","measure":"Peak oxygen consumption (VO2)change","time_frame":"Baseline, 3, 6 months","description":"Difference in the interval changes from baseline to 3 months and 6 months in peak VO2 comparing Experimental group with control."},{"outcome_type":"secondary","measure":"oxygen consumption (VO2) at anaerobic threshold","time_frame":"Baseline, 3, 6 months","description":"Difference in the interval changes from baseline to 3 months and 6 months in VO2 at anaerobic threshold comparing Experimental group with control."},{"outcome_type":"secondary","measure":"Oxygen uptake related to work rate（ΔVO2/ΔWR）change","time_frame":"Baseline, 3, 6 months","description":"Difference in the interval changes from baseline to 3 months and 6 months in Oeygen uptake related to work rate（ΔVO2/ΔWR）comparing experimental group with control."},{"outcome_type":"secondary","measure":"Peak /AT Oxygen Pulse (O2-Pulse)change","time_frame":"Baseline, 3, 6 months","description":"Difference in the interval changes from baseline to 3 months and 6 months in Peak /AT Oxygen Pulse (O2-Pulse) comparing experimental group with control."},{"outcome_type":"secondary","measure":"Peak metabolic equivalent (MET) change","time_frame":"Baseline, 3, 6 months","description":"Difference in the interval changes from baseline to 3 months and 6 months in peak metabolic equivalent (MET) change comparing experimental group with control."},{"outcome_type":"secondary","measure":"Heart rate variability","time_frame":"Baseline, 3, 6 months","description":"Difference in the interval changes from baseline to 3 months and 6 months in Heart rate variability comparing experimental group with control."},{"outcome_type":"secondary","measure":"Body mass index（BMI）change","time_frame":"Baseline, 3, 6 months","description":"Difference in the interval changes from baseline to 3 months and 6 months in Body mass index（BMI）comparing experimental group with control. BMI is the value obtained by dividing body weight by height square (weight in kilograms, height in meters). BMI is a standard commonly used in the world to measure the degree of obesity and health of the human body."},{"outcome_type":"secondary","measure":"LVEF change","time_frame":"Baseline, 3, 6 months","description":"Difference in the interval changes from baseline to 3 months and 6 months in LVEF comparing experimental group with control."},{"outcome_type":"secondary","measure":"NT-proBNP(pg/ml)","time_frame":"Baseline, 3, 6 months","description":"Difference in the interval changes from baseline to 3 months and 6 months in NT-proBNP comparing Experimental group with control."},{"outcome_type":"secondary","measure":"The MOS item short form health survey(SF-36)","time_frame":"Baseline, 3, 6 months","description":"Difference in the interval changes from baseline to 3 months and 6 months in The MOS item short form health survey(SF-36) comparing experimental group with control."}]}
{"nct_id":"NCT04079660","start_date":"2021-02-01","enrollment":50,"brief_title":"Glycemic Control Based on Serum Fructosamine Concentration vs. hemoglobinA1c (HbA1c) in Diabetic Patients","official_title":"Prospective, Observational Study Evaluating the Glycemic Control Based on Serum Fructosamine Concentration vs. hemoglobinA1c (HbA1c) in Diabetic Patients Undergoing Surgeries","primary_completion_date":"2021-02-01","study_type":"Observational","rec_status":"Completed","completion_date":"2021-02-01","last_update":"2021-09-22","description":"Diabetes mellitus is associated with negative outcomes in patients undergoing surgery. Blood sugar levels are monitored by measuring a values that include but are not limited to hemoglobin A1c, capillary blood glucose, and fructosamine . This study is being done to investigate if there is an associated between these values and postsurgical outcomes.","other_id":"2018H0320","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Diabetic patients sover 18 years of age, scheduled to undergo surgery","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Male or female patients able to consent.\r\n\r\n          2. Patients with either Type I or Type II diabetes mellitus (DM)\r\n\r\n          3. Patients undergoing non-cardiac surgeries under general anesthesia\r\n\r\n          4.  18 years of age\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Inability to read, understand or sign the consent form\r\n\r\n          2. End-stage renal disease\r\n\r\n          3. Special populations (Incarcerated individuals, pregnant female patients)\r\n      ","sponsor":"Ohio State University","sponsor_type":"Other","conditions":"Diabetes","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Capillary blood glucose blood draw","description":"Capillary blood glucose (CBG), HbA1c, fructosamine, albumin, BUN, and creatinine values will be obtained from a blood draw as a standard of care"}],"outcomes":[{"outcome_type":"secondary","measure":"wound healing","time_frame":"1 day","description":"Incidence of poor wound healing"},{"outcome_type":"secondary","measure":"delirium","time_frame":"1 day","description":"Incidence of post-operative delirium"},{"outcome_type":"secondary","measure":"reoperation","time_frame":"1 day","description":"Incidence of reoperation procedure"},{"outcome_type":"secondary","measure":"LOS","time_frame":"1 day","description":"Length of PACU stay"},{"outcome_type":"primary","measure":"fasting capillary blood glucose level","time_frame":"1 hour","description":"Association between pre-operative HbA1c and fructosamine with pre-operative, fasting capillary blood glucose level measured the morning of surgery in preoperative holding area."},{"outcome_type":"secondary","measure":"hypoglycemia","time_frame":"1 day","description":"i. Incidence of hypoglycemia, defined as CBG < 70 mg/dL, during the perioperative period"},{"outcome_type":"secondary","measure":"hyperglycemia","time_frame":"1 day","description":"ii. Incidence of hyperglycemia, defined as CBG > 180 mg/dL, during the perioperative period"},{"outcome_type":"secondary","measure":"infection","time_frame":"1 day","description":"Incidence of wound infection"}]}
{"nct_id":"NCT04679766","start_date":"2021-01-31","phase":"N/A","enrollment":10,"brief_title":"Evaluation of Ice Cream Cone Technique With Immediate Implant Placement in Patients With Labial Plate Dehiscence","official_title":"Evaluation of Ice Cream Cone Technique as a Flapless Guided Bone Regenerative Method With Immediate Implant Placement in Management of Patients With Labial Plate Dehiscence: A Case Series","primary_completion_date":"2021-06-30","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2021-07-31","last_update":"2020-12-29","description":"Immediate tooth replacement with immediate implants into fresh extraction sockets has become a common and promising clinical procedure in daily practice in regard of implant survival, osseointegration and esthetic outcomes . However, there are some challenges encountered in the treatment of patients with labial bone plate dehiscence. Deficiency of facial bone anatomy has a negative impact on esthetics and is a critical causative factor for esthetic implant complications and failures .. Few studies investigated the reconstitution of labial bone plate dehiscence using ice cream cone technique and their results showed adequate bone regeneration 4 to 6 months where no labial plate was present prior to grafting technique. Ice cream cone technique as a flapless grafting technique in conjunction with immediate implant placement in patients with labial bone plate dehiscence requires further studies for its clinical relevance and approval.","other_id":"MAmagad","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Non-restorable teeth in maxillary inter-bicuspid region.\r\n\r\n          2. All teeth have labial plate dehiscence (socket type II) after extraction.\r\n\r\n          3. Patients free from any systemic conditions that may affect healing.\r\n\r\n          4. Adequate bone volume for the placement of immediate implant.\r\n\r\n          5. Presence of the adjacent teeth.\r\n\r\n          6. Compliant patients.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Smokers.\r\n\r\n          2. Pregnant females.\r\n\r\n          3. Patients who were taking or currently taking any of the bisphosphonates.\r\n\r\n          4. Any disease that might affect bone metabolism as osteoporosis.\r\n\r\n          5. Insufficient inter-occlusal distance or mesio-distal space to place an implant\r\n             supported restoration.\r\n\r\n          6. The presence of any signs of acute infection in the surgical site or the adjacent\r\n             natural teeth.\r\n      ","sponsor":"Cairo University","sponsor_type":"Other","conditions":"Dental Implant|Guided Bone Regeneration","interventions":[{"intervention_type":"Procedure","name":"Procedure: Ice cream cone technique with immediate implant as a flapless bone regenerative method in management of patients with labial plte dehiscence","description":"Atraumatic extraction will be done The extraction socket will be debrided to remove any residual debris using surgical curettes Socket walls will be checked using a periodontal probe to ensure integrity of all sockets walls except the labial bone plate which must show a dehiscence. Implant placement will be done. All implants will engage at least 3 mm apical to the apical end of the socket with adequate primary stability Resorbable collagen membrane will be cut confirming to the size and shape of the defect of labial bone plate dehiscence. The membrane will be placed against internal surface of the extraction socket against the remaining buccal plate of bone. The gap between the collagen membrane and the implant fixture will be filled with xenograft particulates.The membrane will be folded in palatal direction to seal the socket in an ice cream cone shape, then will be secured using non-resorbable sutures"}],"outcomes":[{"outcome_type":"primary","measure":"Changes in buccal/labial vertical bone dimensions","time_frame":"6 months post operative","description":"Vertical bone dimension will be measured at day 0 and 6 months post-operative"},{"outcome_type":"secondary","measure":"Changes in labial/buccal plate thickness","time_frame":"6 months","description":"Measured at day 0 and 6 months post-operative using Cone beam tomography"},{"outcome_type":"secondary","measure":"Keratinized tissue width","time_frame":"6 months","description":"Measured using william's graduated probe"},{"outcome_type":"secondary","measure":"Gingival thickness","time_frame":"6 months","description":"Measured using william's graduated probe"},{"outcome_type":"secondary","measure":"Post operative pain measured with VAS scale","time_frame":"1 week -2 weeks","description":"VAS scale from 0 to 10, where 0 no pain and 10 with highest pain"},{"outcome_type":"secondary","measure":"Post-operative patient satisfaction with Yes or No question","time_frame":"6 months","description":"Yes or No question of overall patient satisfaction of the procedure"}]}
{"nct_id":"NCT04703712","start_date":"2021-01-31","phase":"N/A","enrollment":316,"brief_title":"Lens Extraction Combined With Goniosynechialysis Versus Trabeculectomy","official_title":"Effectiveness of Lens Extraction Combined With Goniosynechialysis Versus Trabeculectomy in Treating Advanced Angle-closure Glaucoma: a Randomized Controlled Trial","primary_completion_date":"2024-12-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2024-12-31","last_update":"2021-01-11","description":"To compare the effectiveness of lens extraction combined with goniosynechialysis and trabeculectomy in treating advanced angle-closure glaucoma.","other_id":"AAC Glaucoma","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":40,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age between 40 years old to 80 years old\r\n\r\n          2. more than 180-degree synechial closure of anterior chamber angle on gonioscopy\r\n\r\n          3. IOP higher than 21mmHg under the use of more than two anti-glaucoma eye drops\r\n\r\n          4. mean deviation of visual field worse than -12dB on Humphrey 24-2\r\n\r\n          5. phakic eyes\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Snellen visual acuity worse than 0.02\r\n\r\n          2. history of ocular trauma\r\n\r\n          3. uveitis\r\n\r\n          4. previous ocular surgeries\r\n\r\n          5. significant conjunctival scar\r\n\r\n          6. visible neovascular on iris or anterior chamber angle\r\n\r\n          7. other severe eye diseases that would affect visual function significantly, such as\r\n             age-related macular degeneration and pathogenic myopia.\r\n      ","sponsor":"Eye & ENT Hospital of Fudan University","sponsor_type":"Other","conditions":"Glaucoma, Angle-Closure","interventions":[{"intervention_type":"Procedure","name":"Procedure: Lens extraction combined with goniosynechialysis","description":"The patients enrolled underwent phacoemulsification combined with goniosynechialysis surgery."},{"intervention_type":"Procedure","name":"Procedure: Trabeculectomy surgery","description":"The patients enrolled underwent trabeculectomy surgery"}],"outcomes":[{"outcome_type":"secondary","measure":"Number of eye drops","time_frame":"one month, three months, six months, one year, two years, three years","description":"The number of eye drops after surgery."},{"outcome_type":"secondary","measure":"Adverse event","time_frame":"one month, three months, six months, one year, two years, three years","description":"Adverse events of each group, such as cornea edma, ocular hypotension, hemorrhage"},{"outcome_type":"primary","measure":"Intraocular pressure (IOP) change at one month","time_frame":"one month","description":"Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at one month."},{"outcome_type":"primary","measure":"IOP change at three months","time_frame":"three months","description":"Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at three months."},{"outcome_type":"primary","measure":"IOP change at six months","time_frame":"six months","description":"Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at six months."},{"outcome_type":"primary","measure":"IOP change at one year","time_frame":"one year","description":"Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at one year."},{"outcome_type":"primary","measure":"IOP change at two years","time_frame":"two years","description":"Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at two years."},{"outcome_type":"primary","measure":"IOP change at three years","time_frame":"three years","description":"Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at three years."},{"outcome_type":"primary","measure":"Best corrected visual acuity at one month","time_frame":"one month","description":"Best corrected visual acuity of participants after surgery at one month"},{"outcome_type":"primary","measure":"Best corrected visual acuity at three months","time_frame":"three months","description":"Best corrected visual acuity of participants after surgery at three months"},{"outcome_type":"primary","measure":"Best corrected visual acuity at six months","time_frame":"six months","description":"Best corrected visual acuity of participants after surgery at six months"},{"outcome_type":"primary","measure":"Best corrected visual acuity at one year","time_frame":"one year","description":"Best corrected visual acuity of participants after surgery at one year"},{"outcome_type":"primary","measure":"Best corrected visual acuity at two years","time_frame":"two years","description":"Best corrected visual acuity of participants after surgery at two years"},{"outcome_type":"primary","measure":"Best corrected visual acuity at three years","time_frame":"three years","description":"Best corrected visual acuity of participants after surgery at three years"},{"outcome_type":"secondary","measure":"Mean deviation","time_frame":"one month, three months, six months, one year, two years, three years","description":"The mean deviation value of Humphery visual filed tests before and after surgery."},{"outcome_type":"secondary","measure":"The thickness of retinal nerve fiber layer (RNFL)","time_frame":"one month, three months, six months, one year, two years, three years","description":"The RNFL thickness measured by optical coherence topography (OCT)"},{"outcome_type":"secondary","measure":"The thickness of ganglion cell complex (GCC)","time_frame":"one month, three months, six months, one year, two years, three years","description":"The GCC thickness measured by OCT"}]}
{"nct_id":"NCT04572737","start_date":"2021-01-31","phase":"N/A","enrollment":35,"brief_title":"Personalised Activity Plan for BREAKing UP Sitting Time in Patients With Peripheral Arterial Disease and Intermittent Claudication (The BREAK UP Study)","official_title":"Personalised Activity Plan for BREAKing UP Sitting Time in Patients With Peripheral Arterial Disease and Intermittent Claudication (The BREAK UP Study)","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2021-12-31","last_update":"2020-10-27","description":"Intermittent claudication is the most common manifestation of peripheral arterial disease, a common cardiovascular disease that causes blocked blood vessels (arteries) in the leg. Symptoms consist of persistent pain in one or both legs during exercise that is relieved with rest. Evidence suggests that high levels of uninterrupted sitting and sedentary behaviour are associated with cardiovascular disease risk, mortality and all-cause mortality. One of the main goals for treating people with intermittent claudication, is increased participation in physical activity. Supervised Exercise Programmes are recommended however these are not well tolerated and compliance is low. Alternative exercise, including short bouts of physical activity to break up sedentary time, has been suggested to help improve physical function. This study will investigate whether alternative exercise, in the form of breaking up prolonged sitting time, will improve physical function in patients with intermittent claudication. A suite of multi-modal activities will be developed offering a variety of exercise activities which will inform a personalised activity plan for each participant. Patients will be screened during their routine clinic appointment at Glenfield Hospital. All other study activity will take place in a laboratory within the Leicester Diabetes Centre at the Leicester General Hospital (LGH). Patients will be expected to attend LGH for up to a maximum of 4 visits where study data will be collected from performing physical measurements and assessments, and the completion of various questionnaires. Additional data will be collected from activity monitors which will be worn for up to 8 days at baseline and follow-up, measuring step count and time, inactivity, activity time and intensity, and sleep duration. Participants will also be expected to wear activity monitors for the duration of the 8-week intervention to measure steps. Participants will be in the study for approximately 18 weeks in total.","other_id":"0795","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"before and after intervention study","sampling_method":"","gender":"All","minimum_age":40,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Men and women\r\n\r\n          -  Age 40 to 80 years, inclusive\r\n\r\n          -  ABPI <0.9 or >1.3 at rest OR <0.9 during treadmill exercise testing\r\n\r\n          -  History of intermittent claudication (exercise induced, aching/cramping, pain\r\n             affecting the lower limbs or buttocks, which subsides with rest)\r\n\r\n          -  Able and willing to give informed consent\r\n\r\n          -  Able to speak, read, and write English\r\n\r\n          -  Able to undertake light physical activity\r\n\r\n          -  Weight stable;  3kg weight change in preceding 3 months\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Individuals with type 1, gestational, or monogenic diabetes mellitus\r\n\r\n          -  On insulin therapy\r\n\r\n          -  Hospital admission in preceding 3 months\r\n\r\n          -  Current or planned pregnancy, or breast feeding\r\n\r\n          -  Contra-indications to exercise\r\n\r\n          -  Participation in CTIMP currently and/or in preceding 3 months\r\n\r\n          -  Already participating in a structured SEP\r\n\r\n          -  Serious illness with life-expectancy < 1 year\r\n\r\n          -  Previous major amputation\r\n\r\n          -  Recent cardiovascular event (within the last 12 months)\r\n\r\n          -  Comorbidity that the research team considered to be a contraindication to involvement\r\n             in the study\r\n\r\n          -  Unable to communicate in English\r\n\r\n          -  Recent diagnosis or treatment for cancer (within 12 months)\r\n      ","sponsor":"University of Leicester","sponsor_type":"Other","conditions":"Peripheral Arterial Disease","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Activity plan to break up sitting time","description":"This research study aims to prove efficacy of a home-based physical activity intervention targeted at reducing periods of prolonged sitting and improving physical function in patients with intermittent claudication."}],"outcomes":[{"outcome_type":"primary","measure":"To investigate overall changes in sitting time","time_frame":"8 weeks","description":"Measured using accelerometers (comparison of time spent sitting at baseline vs. follow-up assessed via acceleration)"},{"outcome_type":"primary","measure":"The walking impairment questionnaire","time_frame":"8 weeks","description":"Total score for 16 questions measuring walking distance, speed and stair climbing from 0 (worst/inability) to 4 (best/without limitations)"},{"outcome_type":"secondary","measure":"To investigate overall changes in time spent performing physical activity","time_frame":"8 weeks","description":"Measured using accelerometers (comparison of time spent performing physical activity at baseline vs. follow up assessed via mean acceleration mg/day )"},{"outcome_type":"secondary","measure":"To investigate overall changes in time spent in light physical activity","time_frame":"8 weeks","description":"Measured using accelerometers (comparison of time spent in light physical activity at baseline vs. follow up assessed via acceleration mins/day)"},{"outcome_type":"secondary","measure":"To investigate overall changes in time spent in moderate physical activity","time_frame":"8 weeks","description":"Measured using accelerometers (comparison of time spent in moderate physical activity at baseline vs. follow up assessed via acceleration mins/day)"},{"outcome_type":"secondary","measure":"To investigate overall changes in time spent in vigorous physical activity","time_frame":"8 weeks","description":"Measured using accelerometers (comparison of time spent in vigorous physical activity at baseline vs. follow up assessed via acceleration mins/day)"},{"outcome_type":"secondary","measure":"To investigate overall changes in time spent in prolonged sitting","time_frame":"8 weeks","description":"Measured using accelerometers (comparison of time spent sitting at baseline vs. follow-up assessed via acceleration)"},{"outcome_type":"secondary","measure":"To investigate overall changes in time spent in sleep","time_frame":"8 weeks","description":"Measured using accelerometers (comparison of time spent sleeping at baseline vs. follow-up assessed via acceleration)"},{"outcome_type":"secondary","measure":"To investigate whether personalised activity breaks in sitting time improve quality of life","time_frame":"8 weeks","description":"Measured using the Vascular Quality of Life (VascuQoL) questionnaire"},{"outcome_type":"secondary","measure":"To investigate whether personalised activity breaks in sitting time improve quality of life","time_frame":"8 weeks","description":"Measured using the Euro Quality of Life (EQ-5D-5L) questionnaire"},{"outcome_type":"secondary","measure":"To investigate whether personalised activity breaks in sitting time improve breathlessness","time_frame":"8 weeks","description":"Measured using the modified medical research council (mMRC) dyspnoea scale"},{"outcome_type":"secondary","measure":"To investigate whether personalised activity breaks in sitting time improve fatigue","time_frame":"8 weeks","description":"Measured using Chalder's Fatigue Scale"},{"outcome_type":"secondary","measure":"To investigate whether personalised activity breaks in sitting time improve anxiety and depression","time_frame":"8 weeks","description":"Measured using the hospital anxiety and depression scale"}]}
{"nct_id":"NCT04614298","start_date":"2021-01-31","phase":"Phase 4","enrollment":400,"brief_title":"A Phase 4 Study of Brodalumab (KHK4827) in Subjects With Moderate to Severe Plaque Psoriasis","official_title":"A Phase 4 Clinical Study to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy of Brodalumab (KHK4827) in Subjects With Moderate to Severe Plaque Psoriasis","primary_completion_date":"2022-02-28","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2022-11-30","last_update":"2020-11-03","description":"The objective of this study is assessing the efficacy and safety of brodalumab in Chinese subjects with moderate to severe plaque psoriasis.","other_id":"4827-CN001","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Those who are 18 and 70 years of age at the time of signing the written informed\r\n             consent form\r\n\r\n          -  Those who have involved BSA (the percentage (%) of body surface area involved with\r\n             lesion) 10%, PASI (Psoriasis Area and Severity Index) 12 and sPGA (static\r\n             Physician's global assessment)  3 at screening and at baseline.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Those who diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate\r\n             psoriasis or medication-induced psoriasis\r\n\r\n          -  Those who have skin conditions other than psoriasis including eczema at the time of\r\n             the screening that would interfere with evaluations of the study drug.\r\n      ","sponsor":"Kyowa Kirin Co., Ltd.","sponsor_type":"Industry","conditions":"Moderate to Severe Plaque Psoriasis","interventions":[{"intervention_type":"Drug","name":"Drug: KHK4827-Active","description":"Single SC administration"},{"intervention_type":"Drug","name":"Drug: KHK4827-Placebo","description":"Single SC administration"}],"outcomes":[{"outcome_type":"primary","measure":"To evaluate the proportion of subjects achieving 75% improvement from baseline in Psoriasis Area and Severity Index (PASI; PASI 75) at Week 12","time_frame":"Week 12"},{"outcome_type":"secondary","measure":"To evaluate the proportion of subjects achieving 100% improvement from baseline in PASI (PASI 100) at Week 12","time_frame":"Week 12"},{"outcome_type":"secondary","measure":"To evaluate static physician's global assessment (sPGA) of \"clear or almost clear (0 or 1)\" at Week 12","time_frame":"Week 12"},{"outcome_type":"other","measure":"Number of patients with treatment-emergent adverse events (TEAEs) or drug-related TEAEs","time_frame":"after received an investigational product until last visit 1 year"}]}
{"nct_id":"NCT04733976","start_date":"2021-01-22","enrollment":75,"brief_title":"Bullying in Youth With Muscular Dystrophy and Congenital Myopathies","official_title":"Assessing the Frequency and Experience of Bullying or Peer Victimization in Children With Muscular Dystrophy and Congenital Myopathies","primary_completion_date":"2021-07-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2022-09-30","last_update":"2021-02-02","description":"Bullying is an epidemic in Canada, and rates may be underreported. Youth with a disability were more likely to be bullied that those without disabilities, specifically if the disability was visible. Research has been conducted on the prevalence and effects of bullying in youth with disabilities such as cerebral palsy, obesity, and chronic pain; however, there is a paucity of research involving youth with muscular dystrophy and congenital myopathies. The objectives of this study are to: (1) measure bullying frequency, (2) describe the types of bullying experiences; and (3) explore barriers and facilitators to dealing with bullying by youth with muscular dystrophy or congenital myopathies and their parents. The objectives will be met by an online survey and qualitative interviews of youth with muscular dystrophy and congenital myopathy and their parents.","other_id":"McAdam_Bullying","observational_model":"Cohort","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":10,"maximum_age":19,"population":"Youth with a muscular dystrophy or congenital myopathy diagnosis from the neuromuscular\r\n        clinics at the study sites (Holland Bloorview and CHEO) will be invited to participate in\r\n        the study. The youth's parents will also be invited to participate with their child.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Muscular dystrophy or congenital myopathy diagnosis\r\n\r\n          -  10-19 years old\r\n\r\n          -  Speaks and reads English or French\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  N/A\r\n      ","sponsor":"Holland Bloorview Kids Rehabilitation Hospital","sponsor_type":"Other","conditions":"Muscular Dystrophies|Congenital Myopathy","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Demographics Form","time_frame":"Through study completion, 1 year","description":"This form was purposefully developed by the research team to capture characteristics such as age, gender, family demographics, schooling and academic success, muscular dystrophy or congenital myopathy diagnosis, comorbidities, physical function and mobility levels, and technology use. There is a participant version and a parent/guardian version."},{"outcome_type":"primary","measure":"Bullying and Cyberbullying: Perpetrators, Victims and Witnesses Survey (B&C:PVWS)","time_frame":"Through study completion, 1 year","description":"An amended version of the B&C:PVWS, developed by Mishna et al., to identify bullying and cyberbullying experiences of victims and perpetrators. The survey examines types of bullying experiences (e.g., physical, verbal, social, sexual), the context in which bullying occurs (e.g., race, sexual orientation, disability), and the participant's response to bullying and cyberbullying (e.g., sadness, actions taken, etc.). Perspectives on bullying and cyberbullying, as well as thoughts on potential interventions are sought. Questions measuring experiences of bully victimization and perpetration had good internal consistency with Cronbach alphas of .77 and .71, respectively."},{"outcome_type":"primary","measure":"Bullying Perspectives","time_frame":"Through study completion, 1 year","description":"A single question from The Bully Survey by Swearer et al. will be used to capture the youth participant's perspectives on bullying. They will be asked, \"How much do you agree with each sentence?\" on a 5-point scale (Totally false, somewhat false, both true and false, somewhat true, totally true)."},{"outcome_type":"primary","measure":"PedsQL(TM) 3.0 Neuromuscular Module","time_frame":"Through study completion, 1 year","description":"The PedsQL(TM) 3.0 Neuromuscular Module assesses quality of life on three scales: 1) About my neuromuscular disease (17 items), 2) Communication (3 items), and 3) About our family resources (5 items). Participants are asked to indicate how much of a problem each of the statements has been for them on a 5-point Likert scale (0 = Never through 5 = Almost Always). Raw item scores are scaled linearly for a total score out of 100. As well, scale scores can be computed as an average of the total scale score. A higher score indicates better health-related quality of life (HRQoL). Two versions will be used in this study: Child Report (8-12 years old) and Teenager Report (13-18 years old), along with parent reports for each of these versions. All versions being used can be found in Appendix R. The child self-report has exemplary reliability (α = .85)."},{"outcome_type":"primary","measure":"KIDSCREEN-10 Index","time_frame":"Through study completion, 1 year","description":"The KIDSCREEN-10 Index is a 10-item questionnaire developed to assess the HRQoL of children and young people 8-18 years old. Items in the questionnaire ask participants their thoughts on their health over the past week on a 5-point scale (Excellent, very good, good, fair, poor). Rasch analysis of raw scores provides a global unidimensional latent HRQoL score. Higher scores indicate better HRQoL. The KIDSCREEN-10 Index is reported to have good internal consistency (α = .82), and good test-retest reliability and stability (r = .73, ICC = .72)."},{"outcome_type":"primary","measure":"EPOCH Measure of Adolescent Well-being (EPOCH)","time_frame":"Through study completion, 1 year","description":"The EPOCH assesses five positive psychological characteristics (i.e., engagement, perseverance, optimism, connectedness and happiness) that may facilitate the well-being, physical health and other positive outcomes in adulthood. Participants are instructed to indicate how much a statement describes them on a 5-point scale (Almost never, sometimes, often, very often, almost always). There are four items for each of the five domains. The EPOCH has exemplary overall reliability (α = .92)."},{"outcome_type":"primary","measure":"Qualitative Interview","time_frame":"Through study completion, 1 year","description":"Participants will be purposefully selected to complete a semi-structured qualitative interview based on their survey results. Criteria for qualitative interview selection will be based on diversity of gender, school level, muscular dystrophy or congenital myopathy diagnosis, mobility, bullying and cyberbullying victimization, etc. Participants will be asked to describe specific bullying experiences, motivations, perspectives, and getting help."}]}
{"nct_id":"NCT04959513","start_date":"2021-01-22","phase":"N/A","enrollment":15,"brief_title":"GBR With L-PRF Bone Block in Early Healing Phase After Extraction","official_title":"Alveolar Ridge Augmentation Using GBR With L-PRF Bone Block in Early Healing Phase After Dental Extraction: a Consecutive Case Series","primary_completion_date":"2022-04-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-10-31","last_update":"2021-07-13","description":"When the practitioners have to place an implant, it is necessary to have a sufficient amount of bone. This study propose to manage clinical situations by an approach using guided bone regeneration using an L-PRF bone block (composite graft composed of a xenograft, a membrane from the patient's blood and a collagenous membrane) after a short healing period of 6 to 8 weeks after tooth extraction. Alveolar ridge changes will be evaluated regarding soft and hard tissues up to 6 months.","other_id":"2020/19OCT/516","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  To be over 18 years old.\r\n\r\n          -  Be in good general health.\r\n\r\n          -  Have at least one monoradicular tooth (premolar, canine or incisor) that must be\r\n             extracted with the need for bone regeneration and one or more implants afterwards.\r\n\r\n          -  Have a DPSI (Dutch Periodontal Screening Index)  2.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Being a smoker.\r\n\r\n          -  Have \"active\" periodontal problems, have a DPSI > 2.\r\n\r\n          -  Have a contraindication to the insertion of an implant and/or oral surgery.\r\n\r\n          -  Have an active inflammatory and/or autoimmune disease of the oral cavity.\r\n\r\n          -  Treatment with immunosuppressants, corticosteroids or biphosphonates.\r\n\r\n          -  Have a history of cancer, radiotherapy or chemotherapy for cancer within the last 5\r\n             years.\r\n\r\n          -  Have insulin-dependent diabetes.\r\n\r\n          -  Have a blood disorder.\r\n      ","sponsor":"Cliniques universitaires Saint-Luc- Universit Catholique de Louvain","sponsor_type":"Other","conditions":"Alveolar Ridge Augmentation","interventions":[{"intervention_type":"Procedure","name":"Procedure: LPRF bone block","description":"Guided bone regeneration using an L-PRF bone block (composite graft composed of a xenograft, a membrane from the patient's blood and a collagenous membrane) after a short healing period of 6 to 8 weeks after tooth extraction"}],"outcomes":[{"outcome_type":"primary","measure":"Gain in ridge width in millimeters","time_frame":"5 to 8 month after guided bone regeneration","description":"Volumetric analysis of hard tissue using CBCT. They will be performed before extraction (T0), before guided bone regeneration (T1) and 6 months after regeneration before implant placement (T2). The CBCT done at T0 will be used as a reference for comparison with the CBCT T1 and T2. A high-resolution scanning protocol will be used with fixed exposure parameters and the CBCT will be adjusted to the target area to allow a significant reduction in irradiation dose. The DICOMs (Digital Imaging and Communication in Medicine) will be analysed using a dedicated application. The images taken at different times will be superimposed with an automatic algorithm and compared by 2D and 3D volumetric measurements."},{"outcome_type":"secondary","measure":"Volumetric changes of the soft tissue in millimeters","time_frame":"5 to 8 month after guided bone regeneration","description":"Volumetric analysis of soft tissue using digital impressions. They will be made before extraction (T0), before guided bone regeneration (T1) and 6 months after regeneration before implant placement (T2). The impressions taken at the different times will be compared in analysis software. Oral-lingual or oral-palatal measurements will be taken in the center of the edentulous site at 1mm, 3mm and 5mm from the gingiva."},{"outcome_type":"secondary","measure":"Need or not of an additional grafting procedure (yes or no)","time_frame":"5 to 8 month after guided bone regeneration","description":"Analyse of the need for further regeneration before the implant is placed."},{"outcome_type":"secondary","measure":"Analysis of the implant's osseointegration (ISQ)","time_frame":"up to 12 months","description":"An analysis of the osseointegration of the implant using a dedicated device (Osstell IDx, Osstell AB, Göteborg, Sweden)."},{"outcome_type":"secondary","measure":"Patient reported outcomes mesures (VAS Scale)","time_frame":"through study completion, an average of 1 year","description":"Analysis of the patient's feeling thanks to a \"Visual Analog Scale\" scale carried out 1 week after the regeneration surgery."},{"outcome_type":"secondary","measure":"Occurrence of an adverse effect","time_frame":"through study completion, an average of 1 year","description":"Analysis of the infection rate after regeneration."}]}
{"nct_id":"NCT04713904","start_date":"2021-01-16","phase":"Phase 1","enrollment":38,"brief_title":"Bioavailability of Clormadinone/Ethinyl Estradiol Tablets 2 mg/0.02 mg With Regards to Reference Product","official_title":"Bioavailability of Formulation Clormadinone/Ethinyl Estradiol Coated Tablets 2 mg/0.02 mg With Regards to the Marketed Reference Product","primary_completion_date":"2021-01-16","study_type":"Interventional","rec_status":"Completed","completion_date":"2021-02-02","last_update":"2021-04-15","description":"The study will be performed at a single site with 38 subjects. Participantswill take 2 tablets of the test product and reference product in 2 periods and 2 sequences (either test after reference or reference after test). There will be a washout of at least 14 days between each study period.","other_id":"HP8822-01","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Non-pregnant and non-breastfeeding women\r\n\r\n          -  Women of childbearing age with an acceptable form of contraception during the study\r\n\r\n          -  18 to 55 years old inclusive; BMI greater than or equal to 18.51 and less than or\r\n             equal to 29.99\r\n\r\n          -  Non-smoking or smoke only 3 cigarettes every 7 days\r\n\r\n          -  With results of laboratory tests, electrocardiogram and chest radiography in normal\r\n             and / or negative or abnormal ranges but without clinical relevance and declared\r\n             suitable for study by the doctor after the physical examination\r\n\r\n          -  Capable to understand the Informed Consent Form\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Study Site staff or family members\r\n\r\n          -  With history of drug and/or alcohol abuse\r\n\r\n          -  Smokers more tan 3 cigarettes every 7 days\r\n\r\n          -  Vitamin supplements intake 7 days prior to the administration of the medications under\r\n             study\r\n\r\n          -  Any recent change in eating habits or physical exercise\r\n\r\n          -  Using of pharmacological therapy (except over the counter medication use 7 days prior\r\n             the study)\r\n\r\n          -  Hypersensitivity to the study drug or other related compounds, history of serious\r\n             adverse reactions or hypersensitivity to any medication\r\n\r\n          -  Use, during 28 days prior to the start of the study, of medications known to alter\r\n             liver enzyme activity\r\n\r\n          -  Consumption of beverages or food containing grapefruit or pink grapefruit, within 7\r\n             days prior to each administration of the study medication and consumption of alcohol,\r\n             caffeine or beverages or food containing xanthine 24 hours prior each administration\r\n             of study medication until the last sample of each period\r\n\r\n          -  History of any significant cardiovascular disease\r\n\r\n          -  Acute disease that generates significant physiological changes from the start of the\r\n             selection until the end of the study\r\n\r\n          -  HIV, Hepatitis B and/or C positive\r\n\r\n          -  Presence or history of thrombophlebitis, thrombosis or thromboembolic disorder, deep\r\n             vein thrombosis, pulmonary embolism or known coagulopathy.\r\n\r\n          -  Donation or loss of a significant volume (more tan 100 mL) of blood or plasma or\r\n             platelets during the 3 months prior to the start of the study\r\n\r\n          -  Subjects who have participated in any type of clinical study during the 3 months prior\r\n             to the start of the study\r\n\r\n          -  History of any gastrointestinal surgery that could affect drug absorption\r\n\r\n          -  Presence of fainting history or fear to blood collection\r\n      ","sponsor":"Laboratorios Andromaco S.A.","sponsor_type":"Industry","conditions":"Bioequivalence","interventions":[{"intervention_type":"Drug","name":"Drug: Clormadinone 2 mg and Ethinyl estradiol 0.02 mg Test Product Coated Tablets","description":"Investigational Medicinal Product"},{"intervention_type":"Drug","name":"Drug: Clormadinone 2 mg and Ethinyl estradiol 0.02 mg Reference Product Coated Tablets","description":"Evafem 20 (Trademark)"}],"outcomes":[{"outcome_type":"primary","measure":"Total Clormadinone: area under the plasma concentration-time curve from 0 to 72 hours (AUC0-72) ] 21 samples up to 72 hours will be taken after the administration in each period.","time_frame":"[Time Frame: From tablet intake and up to 72 hours after tablet intake]"},{"outcome_type":"primary","measure":"Total Ethinyl estradiol: area under the plasma concentration-time curve from 0 to 72 hours (AUC0-72) ] 21 samples up to 72 hours will be taken after the administration in each period.","time_frame":"[Time Frame: From tablet intake and up to 72 hours after tablet intake]"},{"outcome_type":"primary","measure":"Total Clormadinone: area under the plasma concentration-time curve from 0 to time t (AUC0-t) 21 samples up to 72 hours will be taken after the administration in each period.","time_frame":"[Time Frame: From tablet intake and up to 72 hours after tablet intake]"},{"outcome_type":"primary","measure":"Total Ethinyl estradiol: area under the plasma concentration-time curve from 0 to time t (AUC0-t) 21 samples up to 72 hours will be taken after the administration in each period.","time_frame":"[Time Frame: From tablet intake and up to 72 hours after tablet intake]"},{"outcome_type":"primary","measure":"Total Ethinyl estradiol: Maximum plasma concentration (Cmax) 21 samples up to 72 hours will be taken after the administration in each period. The Cmax will be calculated.","time_frame":"[Time Frame: From tablet intake and up to 72 hours after tablet intake]"},{"outcome_type":"primary","measure":"Total Clormadinone: Maximum plasma concentration (Cmax) 21 samples up to 72 hours will be taken after the administration in each period. The Cmax will be calculated.","time_frame":"[Time Frame: From tablet intake and up to 72 hours after tablet intake]"},{"outcome_type":"secondary","measure":"Total Clormadinone: Time to achieve maximum plasma concentration (tmax) 21 samples up to 72 hours will be taken after the administration in each period. The tmax will be calculated.","time_frame":"[Time Frame: From tablet intake and up to 72 hours after tablet intake]"},{"outcome_type":"secondary","measure":"Total Ethinyl estradiol: Time to achieve maximum plasma concentration (tmax)","time_frame":"[Time Frame: From tablet intake and up to 72 hours after tablet intake]"}]}
{"nct_id":"NCT04626973","start_date":"2021-01-15","phase":"N/A","enrollment":3048,"brief_title":"Effects of Ezetimibe Combination Therapy for Patients With Atherosclerotic Cardiovascular Disease; Randomized Comparison of LDL-cholesterol Targeting <70 Versus <55mg/dL; Ez-PAVE Trial","official_title":"Effects of Ezetimibe Combination Therapy for Patients With Atherosclerotic Cardiovascular Disease; Randomized Comparison of LDL-cholesterol Targeting <70 Versus <55mg/dL; Ez-PAVE Trial","primary_completion_date":"2025-09-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2025-09-30","last_update":"2021-06-11","description":"Although the clinical efficacy of LDL-cholesterol lowering therapy has been proven with strong evidences and emphasized, there are also growing concerns that intensive lipid-lowering therapy would be related to increased risk of adverse effects. In addition, statin potency from recent guidelines was set from the studies composed of mainly Caucasian population, although there is an inconsistency of statin effect according to ethnicity. Asian population showed more profound LDL reduction not only from high potent statin but also from moderate to low potent statin. Conventional strategies for lowering LDL-cholesterol focused on statins, therefore doubling of previously described dose of statin would be common way in patients with inadequate LDL-cholesterol levels. Adding ezetimibe will be an alternative strategy not only to lower LDL-cholesterol level and also to reduce the need of dosage of high-intensity statin to achieve sufficient LDL-cholesterol lowering effect. However, studies regarding the effect of intensive-targeting of lipid-lowering therapy and therapy regimens are lacking. Thus, on these basis, we sought to evaluate whether intensive-targeting of lipid-lowering therapy will have more prominent beneficial effect compared to conventional-targeting in patients with documented ASCVD with either an ezetimibe/statin combination therapy or a statin monotherapy.","other_id":"4-2020-0903","allocation":"Randomized","intervention_model":"Factorial Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"At the time of enrollment, we will stratify all patients according to LDL-cholesterol <100mg/dL, DM, and acute coronary syndrome, and randomly assign them in two groups according to LDL-cholesterol targeting level with a 1:1 ratio: \"Intensive-targeting group\" vs. \"Conventional-targeting group\". In addition, patients in each group will be randomly assigned to receive two lipid-lowering therapy regimen with a 1:1 ratio: \"Ezetimibe/Statin combination therapy\" vs. \"Statin monotherapy\".","sampling_method":"","gender":"All","minimum_age":19,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age 19-80 years\r\n\r\n          2. Documented atherosclerotic cardiovascular disease (ASCVD)\r\n\r\n               -  Previous acute coronary syndrome (myocardial infarction [MI] or unstable angina),\r\n\r\n               -  Or stable angina with imaging or functional studies\r\n\r\n               -  Or coronary revascularization (percutaneous coronary intervention [PCI], coronary\r\n                  artery bypass graft [CABG], and other arterial revascularization procedures)\r\n\r\n               -  Or stroke and transient ischemic attack (TIA)\r\n\r\n               -  Or peripheral artery disease\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. LDL-cholesterol level less than 70 mg/dL without statin therapyAllergy or\r\n             hypersensitive to ezetimibe or statin\r\n\r\n          2. Active liver disease or persistent unexplained serum AST/ALT elevation more than 2\r\n             times the upper limit of normal range\r\n\r\n          3. Allergy or hypersensitivity to any statin or ezetimibe\r\n\r\n          4. Solid organ transplantation recipient\r\n\r\n          5. Pregnant women, women with potential childbearing, or lactating women\r\n\r\n          6. Life expectancy less than 3 years\r\n\r\n          7. Inability to follow the patient over the period of 1 year after enrollment, as\r\n             assessed by the investigator\r\n\r\n          8. Inability to understand or read the informed content\r\n      ","sponsor":"Yonsei University","sponsor_type":"Other","conditions":"Atherosclerotic Cardiovascular Disease","interventions":[{"intervention_type":"Drug","name":"Drug: Ezetimibe/Statin Combination therapy","description":"For statin naive patients, patients would initially receive Ezetimibe 10 mg plus Rosuvastatin 10 mg , For non-statin naive patients, regimens are to be changed to the equivalent dose of ezetimibe+rosuvastatin combination in case of already achieved LDL-cholesterol target (<55 mg/dL) and to be dosed up than the equivalent dose of study drugs in case of not yet achieved LDL-cholesterol target."},{"intervention_type":"Drug","name":"Drug: Statin monotherapy","description":"For statin naive patients, patients would initially receive Ezetimibe 10 mg plus Rosuvastatin 10 mg , For non-statin native patients, regimens are to be change to equivalent dose of atorvastatin or rosuvastatin in case of already achieved LDL-cholesterol target (<55 mg/dL) and to be dosed up than the equivalent dose of study drugs in case of not yet achieved LDL-cholesterol target."},{"intervention_type":"Drug","name":"Drug: Ezetimibe/Statin Combination therapy","description":"For statin naive patients, patients would initially receive Ezetimibe 10 mg plus Rosuvastatin 10 mg , For non-statin naive patients, regimens are to be changed to the equivalent dose of ezetimibe+rosuvastatin combination in case of already achieved LDL-cholesterol target (<70 mg/dL) and to be dosed up than the equivalent dose of study drugs in case of not yet achieved LDL-cholesterol target."},{"intervention_type":"Drug","name":"Drug: Statin monotherapy","description":"For statin naive patients, patients would initially receive Ezetimibe 10 mg plus Rosuvastatin 10 mg , For non-statin native patients, regimens are to be change to equivalent dose of atorvastatin or rosuvastatin in case of already achieved LDL-cholesterol target (<70 mg/dL) and to be dosed up than the equivalent dose of study drugs in case of not yet achieved LDL-cholesterol target."}],"outcomes":[{"outcome_type":"secondary","measure":"Occurrence of statin-associated muscle symptoms (SAMS) requiring change of therapy regimen or dosage","time_frame":"Within 3 years after the enrollment"},{"outcome_type":"primary","measure":"Clinical outcomes by different lipid-lowering therapy","time_frame":"Within 3 years after the enrollment","description":"Composite of cardiovascular death, non-fatal MI, non-fatal stroke, any revascularization, and hospitalization for angina"},{"outcome_type":"secondary","measure":"Each component of primary endpoint within 3 years","time_frame":"Within 3 years after the enrollment","description":"A. Rate of Cardiovascular death\r\nB. Rate of non-fatal MI\r\nC. Rate of non-fatal stroke\r\nD. Rate of any revascularization\r\nE. Rate of hospitalization for angina"},{"outcome_type":"secondary","measure":"Various composite outcomes within 3 years","time_frame":"Within 3 years after the enrollment","description":"A. Rate of composite of cardiovascular death, non-fatal MI, and non-fatal stroke\r\nB. Rate of composite of cardiovascular death, non-fatal MI, non-fatal stroke, and any revascularization\r\nC. Rate pf composite of cardiovascular death, non-fatal MI, and any revascularization\r\nD. Rate of composite of all-cause death, non-fatal MI, non-fatal stroke, any revascularization, and hospitalization for angina"},{"outcome_type":"secondary","measure":"Proportion of subjects achieving target LDL-cholesterol level","time_frame":"Within 3 years after the enrollment"},{"outcome_type":"secondary","measure":"Rate of cross-over into the non-allocated therapy regimen in order to achieve target LDL-cholesterol level","time_frame":"Within 3 years after the enrollment"},{"outcome_type":"secondary","measure":"Proportions of subjects requiring proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to achieve target LDL-cholesterol level","time_frame":"Within 3 years after the enrollment"},{"outcome_type":"secondary","measure":"Difference in rate of primary outcome according to sex","time_frame":"Within 3 years after the enrollment"},{"outcome_type":"secondary","measure":"Difference in rate of primary outcome according to body mass index","time_frame":"Within 3 years after the enrollment"},{"outcome_type":"secondary","measure":"Rate of New-onset diabetes mellitus","time_frame":"Within 3 years after the enrollment"},{"outcome_type":"secondary","measure":"Rate of worsening of glycemic control or homeostatic model assessment (HOMA)-index","time_frame":"Within 3 years after the enrollment"},{"outcome_type":"secondary","measure":"Occurence of elevation of muscle enzymes (CPK > 4 x UNL)","time_frame":"Within 3 years after the enrollment"},{"outcome_type":"secondary","measure":"Occurence of elevation of hepatic enzymes (AST, ALT, or both ≥ 3 x UNL)","time_frame":"Within 3 years after the enrollment"},{"outcome_type":"secondary","measure":"Occurence of elevation of serum creatinine level (>50% from baseline)","time_frame":"Within 3 years after the enrollment"},{"outcome_type":"secondary","measure":"Change of proteinuria","time_frame":"Within 3 years after the enrollment"},{"outcome_type":"secondary","measure":"Rate of cancer diagnosis","time_frame":"Within 3 years after the enrollment"},{"outcome_type":"secondary","measure":"Rate of operation due to cataract","time_frame":"Within 3 years after the enrollment"}]}
{"nct_id":"NCT04690582","start_date":"2021-01-15","phase":"N/A","enrollment":150,"brief_title":"Improving Treatment Outcomes for Suicidal Veterans With PTSD","official_title":"Enhancing the Effectiveness of Cognitive Processing Therapy Among Suicidal Military Veterans With PTSD","primary_completion_date":"2022-12-31","study_type":"Interventional","rec_status":"Enrolling by invitation","completion_date":"2022-12-31","last_update":"2021-02-24","description":"The efficacy of cognitive processing therapy (CPT) for reducing the symptoms of posttraumatic stress disorder (PTSD) across populations including military personnel and veterans is well supported. CPT also contributes to significant and rapid reductions in suicide ideation among people diagnosed with PTSD, although available evidence suggests this effect decays over time. Studies also show that approximately 1 in 6 people who begin CPT without suicide ideation will subsequently report suicidal thoughts at some point during or soon after completing treatment. Research focused on improving CPT's effects on suicide risk is therefore warranted. The primary aim of this study is to determine if the integration of a crisis response plan (CRP)--an empirically-supported procedure for reducing suicide ideation and attempts--can lead to faster reductions in suicide ideation among acutely suicidal veterans receiving CPT and prevent the development of suicide ideation among veterans who begin CPT without suicide ideation.","other_id":"2020H0431","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18 years of age or older\r\n\r\n          -  Current or prior service in the U.S. military\r\n\r\n          -  Current diagnosis of PTSD or subthreshold PTSD\r\n\r\n          -  Ability to speak and understand the English language\r\n\r\n          -  Ability to complete the informed consent process.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Substance use disorder requiring medical management\r\n\r\n          -  Imminent suicide risk warranting inpatient hospitalization or suicide-focused\r\n             treatment\r\n\r\n          -  Impaired mental status that precludes the ability to provide informed consent (e.g.,\r\n             intoxication, psychosis, mania)\r\n      ","sponsor":"Ohio State University","sponsor_type":"Other","conditions":"Suicidal Ideation|Suicide, Attempted|Ptsd","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Cognitive Processing Therapy (CPT)","description":"Cognitive processing therapy (CPT) is a specific type of cognitive behavioral therapy that has been effective in reducing symptoms of PTSD that have developed after experiencing a variety of traumatic events including child abuse, combat, rape and natural disasters. CPT is generally delivered over 12 sessions and helps patients learn how to challenge and modify unhelpful beliefs related to the trauma. In so doing, the patient creates a new understanding and conceptualization of the traumatic event so that it reduces its ongoing negative effects on current life. This treatment is strongly recommended for the treatment of PTSD."},{"intervention_type":"Behavioral","name":"Behavioral: Crisis Response Plan (CRP)","description":"The crisis response plan (CRP) is a collaborative, patient-centered intervention that is typically handwritten on an index cards and focuses on several key components: (1) warning signs, (2) self-regulatory strategies, (3) reasons for living, (4) sources of social support, and (5) professional and crisis services."},{"intervention_type":"Behavioral","name":"Behavioral: Safety Planning Intervention (SPI)","description":"The safety planning intervention (SPI) is a suicide-focused intervention typically handwritten on a pre-printed form that includes the following sections: (1) warning signs, (2) internal coping strategies, (3) people and social settings that provide distraction, (4) people who can offer help, (5) professionals or agencies they can contact during a crisis, and (6) making the environment safe."},{"intervention_type":"Behavioral","name":"Behavioral: Narrative Assessment","description":"The narrative assessment is a patient-centered assessment approach in which the clinician invites the patient to share \"the story\" of a recent crisis or period of intense emotional distress. Patients are asked to identify the thoughts, emotions, and physical sensations experienced in the time leading up to this crisis, as well as the contextual and environmental characteristics surrounding the crisis. Information obtained from the narrative assessment is then used to help formulate a crisis response plan."}],"outcomes":[{"outcome_type":"primary","measure":"Change in suicide ideation","time_frame":"Baseline (Pretreatment), 1 week, 2 weeks, 26 weeks, 52 weeks","description":"Suicide ideation will be measured using the Scale for Suicide Ideation, an empirically-supported self-report scale that assesses the intensity of suicide-related thoughts, urges, intentions, and behaviors. Scores range from 0 to 38, with higher scores indicating more severe suicide ideation."},{"outcome_type":"primary","measure":"Percent with follow-up suicidal behaviors","time_frame":"52 weeks","description":"Percent of participants with one or more suicidal behaviors will be measured using the Self-Injurious Thoughts and Behaviors Interview-Revised, an empirically-supported self-report scale that assesses a range of self-injurious behaviors including suicide attempts, interrupted suicide attempts, preparatory behaviors, and non-suicidal self-injury during the 52 week follow-up. Suicidal behaviors will be coded with a binary variable indicating the presence or absence of any suicidal behavior during the study period."},{"outcome_type":"secondary","measure":"Change in PTSD symptoms","time_frame":"Baseline (Pretreatment) , 1 week, 2 weeks, 26 weeks, 52 weeks","description":"Change in PTSD symptom severity will be measured using the National Stressful Events Survey PTSD Short Scale. Scores range from 0 to 36, with higher scores indicating more severe PTSD symptoms."},{"outcome_type":"secondary","measure":"Change in psychiatric symptoms","time_frame":"Baseline (Pretreatment), 1 week, 2 weeks, 26 weeks, 52 weeks","description":"Psychiatric symptom severity will be measured using the DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure, a 23-item self-report scale of symptoms that cut across 13 diagnostic domains (e.g., depression, anger, mania, anxiety, psychosis, etc.)."},{"outcome_type":"secondary","measure":"Change in psychological well-being","time_frame":"Baseline (Pretreatment), 1 week, 2 weeks, 26 weeks, 52 weeks","description":"Psychological well-being will be measured using the Ryff Scales of Psychological Well-Being. Scores range from 18 to 126, with higher scores indicating higher levels of well-being."}]}
{"nct_id":"NCT04660500","start_date":"2021-01-15","phase":"N/A","enrollment":105,"brief_title":"Driving Performance of People With Parkinson's Using Autonomous In-Vehicle Technologies","official_title":"Driving Performance of People With Parkinson's Using Autonomous In-Vehicle Technologies","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-12-31","last_update":"2021-01-20","description":"For drivers with Parkinson's Disease (PD), autonomous in-vehicle technologies may help mitigate functional deficits, improve driving performance, decrease driving errors and enhance their ability to stay on the road. Using a pretest/posttest design the investigators will quantify the use of In-vehicle Information Systems (IVIS) and Advanced Driver Assistance Systems (ADAS) during driving to illustrate how IVIS and ADAS may affect driving, and provide recommendations to drivers with PD, the clinical community and industry.","other_id":"IRB202002321","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":35,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Subjects diagnosed by a neurologist/ movement disorder specialist with clinically\r\n             probable PD by Movement Disorders Society (MDS) criteria 25\r\n\r\n          2. Has mild or moderate disease severity, based on the MDS-Unified Parkinson's Disease\r\n             Rating Scale for motor symptoms (hereafter referred to as the UPDRS section 3) in the\r\n             on state of medications (i.e., one hour of taking PD medications) and the Modified\r\n             Hoehn and Yahr disease severity scale\r\n\r\n          3. Is representative of one of two PD groups based on age, i.e., participants with\r\n             symptom onset between 35-64 years of age (younger onset), or participants with symptom\r\n             onset between ages 65- 85 years (older onset)\r\n\r\n          4. Currently driving with a valid license\r\n\r\n          5. Meets the Florida state requirement for visual acuity of at least 20/50 in one eye, if\r\n             one eye is blind or 20/200 or worse the other eye must be 20/40 or better (20/40 in at\r\n             least one eye) and field of vision (130 degrees or more)\r\n\r\n          6. Lives independently in the community\r\n\r\n          7. Proficient in reading/speaking English\r\n\r\n          8. A Montreal Cognitive Assessment (MoCA) score of 20 or higher\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Concurrent neurological conditions (e.g., stroke, seizures; dementia)\r\n\r\n          2. Severe psychiatric (e.g., psychoses/ significant anxiety) or physical conditions\r\n             (e.g., missing limbs) precluding full participation\r\n\r\n          3. Use of psychotropic medications having adverse effect on mental/physical functioning\r\n\r\n          4. Severe, unpredictable motor fluctuations\r\n\r\n          5. Severe sleep difficulties.\r\n      ","sponsor":"University of Florida","sponsor_type":"Other","conditions":"Parkinson Disease","interventions":[{"intervention_type":"Other","name":"Other: PD Drivers Using AV Technologies On-road","description":"All drives will include events to assess the impact of in-vehicle information systems (IVIS) and advanced driver assistance systems (ADAS) on the driving performance (driving errors) of drivers with PD. For IVIS the investigators will include options to assess errors with lane maintenance (with and without the lane departure warning system) and signaling (with and without blind spot detection). For ADAS the investigators will include conditions to assess errors in speeding (with and without adaptive cruise control) and lane exceedances (with and without lane keeping assist)."}],"outcomes":[{"outcome_type":"primary","measure":"Total number of driving errors","time_frame":"1 year up to study completion","description":"The evaluator will record the total number of driving errors by number and type (i.e., speeding, lane maintenance, and signaling) on a standardized data collection form."},{"outcome_type":"primary","measure":"Type and number of driving errors","time_frame":"1 year up to study completion","description":"Type of driving errors include: speeding, lane maintenance and signaling on-road recorded by the evaluator, or via vehicle recorded kinematics and telematics (e.g., in-vehicle GPS to record speed)."}]}
{"nct_id":"NCT04226742","start_date":"2021-01-14","phase":"N/A","enrollment":100,"brief_title":"Evaluation of a Crowd-Powered Web Platform for Depression and Anxiety","official_title":"Evaluation of the Crowd-Powered Web Platform for Accumulative Depression and Anxiety Plans and Treatment (ADAPT)","primary_completion_date":"2021-11-05","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2022-02-28","last_update":"2021-09-10","description":"100 participants will be enrolled in a two-armed randomized controlled trial of the Accumulated Depression and Anxiety Plans and Treatments (ADAPT) platform which integrates internet Cognitive Behavioral Therapy (iCBT) to determine impact on symptoms of depression and anxiety. This trial will pilot the effectiveness of the ADAPT platform, and evaluate the extent to which the ADAPT platform engages putative targets of personal relevance, skills use, and skills mastery.","other_id":"HS#2019-4901, HS#2020-6071","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","intervention_model_description":"Participants will be randomly assigned to receive either the treatment condition (ADAPT platform, iCBT platform comprised of didactic and interactive content), or a control condition (iCBT comparison platform comprised only of didactic content).","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  1) Completion of the Mental Health America Screening to Supports (MHA S2S) or\r\n             significant mood and anxiety symptoms as defined by an accepted cut-off on a validated\r\n             measure the Depression Anxiety and Stress Scale (DASS). The accepted cut-off is scores\r\n             greater than 22;\r\n\r\n          -  2) able to speak and read English;\r\n\r\n          -  3) at least 18 years of age.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  1) severe suicidality (has ideation, plan, and intent)\r\n      ","sponsor":"University of California, Irvine","sponsor_type":"Other","conditions":"Depression, Anxiety","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: ADAPT Platform (Treatment)","description":"The ADAPT platform consists of 2 modules based on evidence-based strategies from cognitive-behavioral therapy including cognitive restructuring and behavioral experiments. The platform includes didactic material, interactive tools, and crowd-features. Crowd-features are present to increase personal relevance of content and to promote engagement with the ADAPT platform through accountability. Crowd-features include requesting, responding, and exemplars."},{"intervention_type":"Behavioral","name":"Behavioral: ADAPT Comparison (Control)","description":"The control platform is a self-guided version of the ADAPT platform that includes no crowd-features. As such it will include only didactic material on cognitive restructuring and behavioral experiments and interactive tools."}],"outcomes":[{"outcome_type":"primary","measure":"Change in Depression at 16 weeks","time_frame":"Change from Baseline to Week 4, Week 8, and Week 16","description":"The primary outcome of symptoms of depression will be measured with the self-report Depression Anxiety Stress Scale (DASS) which produces a single score from 0-56 as well as subscores for depression that ranges from 0-56."},{"outcome_type":"primary","measure":"Change in Anxiety at 16 weeks","time_frame":"Change from Baseline to Week 4, Week 8, and Week 16","description":"The primary outcome of symptoms of anxiety will be measured with the self-report DASS, which produces a single score from 0-56."},{"outcome_type":"secondary","measure":"Change in Diagnostic Status at 16 weeks","time_frame":"Change from Baseline to Week 4, Week 8, and Week 16","description":"A secondary outcome is diagnostic status as assessed using the Structured Clinical Interview for DSM-5 (SCID-5). Diagnostic status will also be used as a moderator of change in depressive and anxiety symptoms."},{"outcome_type":"secondary","measure":"Change in use of cognitive and behavioral skills at 16 weeks","time_frame":"Change from Baseline to Week 4, Week 8, and Week 16","description":"A secondary outcome is the Cognitive and Behavioral Response to Stress Scale (CB-RSS), which produces separate scores for frequency and usefulness of cognitive and behavioral skills. Scores for frequency and usefulness each range from 0-54."},{"outcome_type":"secondary","measure":"Change in Self-efficacy at 16 weeks","time_frame":"Change from Baseline to Week 4, Week 8, and Week 16","description":"A secondary outcome is the Coping Self-Efficacy (CSE), which produces a single score that ranges from 0-260."},{"outcome_type":"secondary","measure":"Change in Accountability at 16 weeks","time_frame":"Change from Baseline to Week 4, Week 8, and Week 16","description":"A secondary outcome is the Supportive Accountability Questionnaire (SAQ), which produces a single score than ranges from 7-91. The SAQ also produces scores of subscales including bond, accountability, and legitimacy."},{"outcome_type":"secondary","measure":"Change in Social Functioning at 16 weeks","time_frame":"Change from Baseline to Week 4, Week 8 and Week 16","description":"Functioning will be assessed with the Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities Scale which produces raw scores from 8 to 40. These scores can be standardized to be reported as T-scores that have a mean of 50 and a standard deviation of 10."}]}
{"nct_id":"NCT04271748","start_date":"2021-01-14","phase":"N/A","enrollment":20,"brief_title":"The Impact of Time Restricted Feeding in Crohn's Disease","official_title":"The Impact of Time Restricted Feeding in Crohn's Disease","primary_completion_date":"2021-06-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-06-30","last_update":"2021-02-02","description":"Time-restricted feeding (TRF) is a dietary regimen involving the consumption of food and liquids within a defined time window with or without additional restriction on dietary composition. TRF has been associated with improvements in inflammation, host metabolism, autophagy, gut microbial composition, and gut permeability. Crohn's disease is an inflammatory bowel disease of unknown etiology that likely results from a combination of genetic and environmental factors. This proposed study will test the hypothesis that a time-restricted feeding regimen will improve clinical outcomes and favorably influence the gut microbiome in patients with active Crohn's disease. If time-restricted fasting proves beneficial to this patient population then it will pave the way for larger, prospective studies and clinical trials.","other_id":"19-11021081","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subjects has active Crohn's disease of the ileum and/or colon. The diagnosis should be\r\n             confirmed by endoscopic or radiological evidence.\r\n\r\n          -  Active inflammation on colonoscopy performed as evidenced by an SES-CD  6 (or  4 for\r\n             isolated ileal disease) OR C-Reactive protein  1.0 mg/L OR fecal calprotectin  250\r\n             g/g. Any or all of these results must be from within 180 days of study entrance.\r\n\r\n          -  Subject should have BMI of >18.5 and <40\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subjects who decline to provide informed consent\r\n\r\n          -  Subject with a history of an eating disorder, major gastrointestinal surgery within\r\n             the past 3 months.\r\n\r\n          -  Subject with a history of antibiotic use within 4 weeks.\r\n\r\n          -  Subject with a history of bowel obstruction within the past 12 months\r\n\r\n          -  Subject with a history of diabetes requiring medication\r\n\r\n          -  Subject who is currently pregnant or breastfeeding will be excluded\r\n\r\n          -  Subjects with current antibiotic use. In order to participate, subjects will be\r\n             required to have a 2-week wash-out period.\r\n      ","sponsor":"Weill Medical College of Cornell University","sponsor_type":"Other","conditions":"Crohn's Disease (CD)","interventions":[{"intervention_type":"Other","name":"Other: Time Restricted Feeding","description":"The counseling on the regimen will involve instructing the subjects on study compliance and fasting times. Subjects will be instructed to choose an eight-hour eating window (e.g., 11:00am - 7:00pm) during which the patient will be able to eat his/her normal diet. During the 16-hour fasting window (e.g., 7:00pm - 11:00am), the participant will be able to drink regular water and black coffee."}],"outcomes":[{"outcome_type":"primary","measure":"Change in patient reported outcomes as measured by Patient Recorded Outcome 2 (PRO2) scores.","time_frame":"Baseline (Week 0); 4 weeks after incorporating time restricted feeding into diet","description":"This will be measured to assess clinical response as determined by a reduction of either 8 or more points or a total PRO2 score of less than or equal to 8 points. The PRO2 score scale ranges from a score of 0 as the minimum and has no maximum limit. A score below 8 is considered remission; a score less than 14 is considered mild; and a score greater than 34 is considered severe."},{"outcome_type":"primary","measure":"Change in Inflammatory Markers as measured by blood C-reactive protein (CRP).","time_frame":"Baseline (Week 0); 4 weeks after incorporating time restricted feeding into diet","description":"This will be measured to assess clinical response as determined by a reduction of 50% or more from baseline or normalization of the CRP level results."},{"outcome_type":"primary","measure":"Change in inflammatory markers as measured by fecal calprotectin lab results","time_frame":"Baseline (Week 0); 4 weeks after incorporating time restricted feeding into diet","description":"This will be measured to assess clinical changes as determined by a reduction of 50% or more from baseline or normalization of the calprotectin levels results."},{"outcome_type":"secondary","measure":"Change in taxonomic composition of the gut microbiome as measured by Polymerase Chain Reaction (PCR) analysis.","time_frame":"Baseline (Week 0); 4 weeks after incorporating time restricted feeding into diet","description":"This will be measured to assess the impact of time restricted feeding on intestinal microbiota composition."},{"outcome_type":"secondary","measure":"Markers of systemic peripheral blood immunity as measured by Mass Cytometry by Time-Of-Flight (CyTOF) analysis.","time_frame":"Baseline (Week 0); 4 weeks after incorporating time restricted feeding into diet","description":"This will be measured to assess the effect of time restricted feeding on immune cell composition."}]}
{"nct_id":"NCT04575207","start_date":"2021-01-12","phase":"N/A","enrollment":2132,"brief_title":"The Flash FFR  Study","official_title":"A Prospective, Multicenter, Blinded, Randomized, Noninferiority Clinical Trial of Coronary Angiography Fractional Flow Reserve (caFFR) Versus Fractional Flow Reserve (FFR) to Guide Percutaneous Coronary InterventionFlash FFR  ","primary_completion_date":"2023-06-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2024-06-30","last_update":"2021-01-15","description":"The overall purpose of Flash FFR  is to investigate whether coronary angiography-derived fractional flow reserve (caFFR), compared with fractional flow reserve (FFR) measured by a pressure wire, has non-inferior clinical effect and cost benefit in guiding the percutaneous coronary intervention (PCI) for patients with moderate coronary artery stenosis in terms of long-term clinical prognosis.","other_id":"SZRMD2020001","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Diagnostic","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":19,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  General inclusion criteria:\r\n\r\n               1. Age above 18 years old, no limit on the gender;\r\n\r\n               2. Angiography is considered necessary and feasible by investigator, and PCI will be\r\n                  performed if necessary;\r\n\r\n               3. Suspected coronary heart disease, stable angina pectoris, unstable angina\r\n                  pectoris, non-culprit vascular assessment in participants with acute\r\n                  non-ST-segment elevation myocardial infarction, and non-culprit vascular\r\n                  assessment in patients with previous ST-segment elevation acute myocardial\r\n                  infarction;\r\n\r\n               4. Participants voluntarily participate in this clinical trial and sign informed\r\n                  consent form.\r\n\r\n          -  Coronary angiography inclusion criteria:\r\n\r\n        The presence of at least one stenosis and meets the following imaging findings:\r\n\r\n          1. The degree of coronary artery stenosis50% and 90% by visual measurement;\r\n\r\n          2. The reference diameter of the stenotic segment2.25 mm by visual measurement;\r\n\r\n          3. The investigator visually observes the target vessel through angiographic images, and\r\n             consider that PCI surgery is technically feasible.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  General exclusion criteria:\r\n\r\n               1. Acute ST-segment elevation myocardial infarction within 6 days;\r\n\r\n               2. Cardiogenic shock or left ventricular ejection fraction50%;\r\n\r\n               3. eGFR < 30 mL/min (1.73 m2);\r\n\r\n               4. Severe coagulation dysfunctions or bleeding disorders;\r\n\r\n               5. Allergic to iodine contrast medium or contraindications for adenosine\r\n                  administration;\r\n\r\n               6. Severe aortic stenosis;\r\n\r\n               7. Life expectancy less than 1 year;\r\n\r\n               8. Pregnant women or women planning a recent pregnancy;\r\n\r\n               9. Participation in any other clinical trials of devices or drugs (ongoing or within\r\n                  the past 1 month);\r\n\r\n              10. The investigator believes that the particitant has other conditions that are not\r\n                  suitable for clinical trials.\r\n\r\n          -  Coronary angiography exclusion criteria:\r\n\r\n               1. TIMI flow in the target vessel<grade III ;\r\n\r\n               2. Presence of myocardial bridge and systolic compression 50% in the target vessel;\r\n\r\n               3. Presence of artificial bypass in the target vessel;\r\n\r\n               4. Left main coronary artery or right coronary artery ostial lesions;\r\n\r\n               5. Stent implantation in the target vessel within 3 months;\r\n\r\n               6. Target vessel provides collateral support to chronically total occluded vessels;\r\n\r\n               7. Presence of factors affecting angiographic analysis and stenosis visualization,\r\n                  including incomplete vessel opacification, or overlap with other coronary\r\n                  branches of extreme vessel foreshortening.\r\n      ","sponsor":"Peking University First Hospital","sponsor_type":"Other","conditions":"Coronary Artery Disease|Coronary Stenosis|Myocardial Ischaemia|Coronary Circulation|Stable Angina Pectoris|Unstable Angina Pectoris|Asymptomatic Ischemia|Acute Myocardial Infarction|Percutaneous Coronary Intervention","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: caFFR","description":"caFFR is a new index of physiological assessment of coronary artery stenosis severity, based on angiographic images. Through two-dimensional analysis and three-dimensional reconstruction of two coronary angiography image series with an angle-off > 30 degrees, combined with fluid mechanics, TIMI frame counting method, and optimized CFD algorithm, the pressure drop from coronary ostium to every point in the vessel can be obtained, and then the caFFR value of each point in the vessel can be computed. The cutoff value in this trial is caFFR  0.80 for myocardial ischemia."},{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: FFR","description":"FFR is a widely used, pressure-based functional assessment index of coronary stenoses obtained with an intracoronary pressure wire fitted with pressure sensors. The pressure wire passes through the stenosis and directly measures the pressure distal to the stenosis. FFR value can be obtained by combining the pressure at the coronary ostium and the distal pressure to the stenosis. The cutoff value in this trial is FFR  0.80 for myocardial ischemia."}],"outcomes":[{"outcome_type":"primary","measure":"MACE","time_frame":"1 year","description":"A composite of all-cause death, myocardial infarction (MI), and unplanned revascularization"},{"outcome_type":"secondary","measure":"MACE（excluding PCI-related MI）","time_frame":"1 month, 1 year, 2 years","description":"A composite of all-cause death, myocardial infarction (excluding PCI-related), and unplanned revascularization"},{"outcome_type":"secondary","measure":"Death","time_frame":"1 month, 6 months, 1 year, 2 years","description":"Cardiovascular, non-cardiovascular, and undetermined death"},{"outcome_type":"secondary","measure":"MI","time_frame":"1 month, 6 months, 1 year, 2 years","description":"Target vessel related and non-target vessel related MI"},{"outcome_type":"secondary","measure":"Target vessel revascularization (TVR)","time_frame":"1 month, 6 months, 1 year, 2 years","description":"The ischemia driven and non-ischemia driven TVR"},{"outcome_type":"secondary","measure":"Any coronary artery revascularization","time_frame":"1 month, 6 months, 1 year, 2 years","description":"The ischemia driven and non-ischemia driven revascularization"},{"outcome_type":"secondary","measure":"Definite or probable stent thrombosis","time_frame":"1 month, 6 months, 1 year, 2 years","description":"Definite and probable stent thrombosis during acute, sub-acute, late, and very late phase"},{"outcome_type":"secondary","measure":"Evaluation of health economics","time_frame":"1 month, 6 months, 1 year","description":"Cost-utility analysis and computation of incremental cost-effectiveness ratio."},{"outcome_type":"secondary","measure":"Analysis of participant discomfort during the operation (none/mild/moderate/severe )","time_frame":"During the operation","description":"During the caFFR or FFR detection, the operator will ask the participant if there is discomfort (none/mild/moderate/severe ) and what kind of discomfort(such as palpitation, chest stuffy , nausea, dizziness, foreign body invasion ), and fill out a questionnaire after the operation.The discomfort of all participants caused by the use of drugs, intervention, etc. during the caFFR or FFR detection will be analyzed."},{"outcome_type":"secondary","measure":"The changes of PCI strategy depending on caFFR/FFR information","time_frame":"During the operation","description":"Before randomization,the operators will be asked to provide their planned treatment strategy based on the angiographic information alone.\r\nAfter randomization and functional assessment,we will record how caFFR/FFR changed the treatment strategy."}]}
{"nct_id":"NCT04466007","start_date":"2021-01-11","phase":"Phase 2","enrollment":90,"brief_title":"Safety and Efficacy of Allogeneic Adipose Tissue Mesenchymal Stem Cells in Diabetic Patients With Critical Limb Ischemia","official_title":"Multicenter, Randomized, Dose-search, Parallel, Double-blind, and Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of Intramuscular Administration of Allogeneic Adipose Tissue Adult Mesenchymal Stem Cells in Diabetic Patients With Critical Limb Ischemia Without Possibility of Revascularization","primary_completion_date":"2022-06-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-06-30","last_update":"2021-05-26","description":"Phase II national, multicenter, double-blind, randomized, placebo-controlled, phase-3 clinical trial of 3 parallel groups.","other_id":"NOMA (No More Amputations)","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":40,"maximum_age":90,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Patients must meet ALL of the following criteria to be included in the study:\r\n\r\n          -  Patients of both sexes.\r\n\r\n          -  Age between 40 and 90 years.\r\n\r\n          -  Type 2 diabetes established with more than 1 year since diagnosis.\r\n\r\n          -  Severe grade vascular arteriosclerosis (category RB 4 and 5 mono or bilateral).\r\n\r\n          -  Impossibility of surgical or endovascular revascularization or failure in\r\n             revascularization surgery performed, at least 30 days before inclusion in the study,\r\n             defining failure as direct non-arrival of vessels to the plantar arch.\r\n\r\n          -  Normal biochemical parameters defined by:\r\n\r\n               -  Leukocytes> 3000 / mm3\r\n\r\n               -  Neutrophils> 1500 / mm3\r\n\r\n               -  Platelets> 100,000 / mm3\r\n\r\n               -  AST / ALT <2.5x upper limit of normal\r\n\r\n          -  In patients with an ischemic ulcer, it must be stable for at least 1 week.\r\n\r\n          -  Patients under conventional medical treatment for CLI.\r\n\r\n          -  Women of childbearing age must obtain a negative result in a urine pregnancy test\r\n             performed at the time of inclusion in the study and commit to using an effective\r\n             contraceptive method during their participation in the study.\r\n\r\n          -  Patients who have not participated in any other clinical trial during the 3 months\r\n             prior to the inclusion visit.\r\n\r\n          -  Patients who sign the informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Patients who present SOME of the following criteria may not be selected to participate in\r\n        this study:\r\n\r\n          -  CLI with tissue loss in the target member (category 6 of RB).\r\n\r\n          -  Previous major amputation in the target member.\r\n\r\n          -  Uncontrolled hypertension (defined as PAS> 180 or PAD> 110 in at least 2\r\n             determinations during the selection period).\r\n\r\n          -  Patients with severe heart failure or ejection fraction less than 30%.\r\n\r\n          -  Patients with a previous diagnosis of ventricular arrhythmias or unstable angina.\r\n\r\n          -  Patients with septicemia.\r\n\r\n          -  Patients diagnosed with deep vein thrombosis in the 3 months prior to their inclusion\r\n             in the study.\r\n\r\n          -  Concomitant therapy that includes hyperbaric oxygen, angiogenic agents or Cox II\r\n             inhibitors.\r\n\r\n          -  Contraindication to perfusion NMR.\r\n\r\n          -  Proliferative retinopathy without treatment.\r\n\r\n          -  Diabetic nephropathy in hemodialysis.\r\n\r\n          -  Patients previously treated with cell therapy, gene therapy or growth factors in the\r\n             last year.\r\n\r\n          -  Concomitant disease that limits life expectancy to 1 year or that does not ensure the\r\n             follow-up period.\r\n\r\n          -  Patients who have suffered a stroke or myocardial infarction in the 3 months prior to\r\n             the inclusion visit.\r\n\r\n          -  Severe anemia (hemoglobin <7.9g / dl) in the inclusion analysis.\r\n\r\n          -  Patients with a previous diagnosis of chronic alcoholism.\r\n\r\n          -  Any clinically significant anomaly detected in the Selection Period and which, in the\r\n             opinion of the investigator, constitutes an impediment to the correct participation of\r\n             the patient in the study or the fulfillment of the procedures established therein.\r\n      ","sponsor":"Instituto de Investigacin Sanitaria de la Fundacin Jimnez Daz","sponsor_type":"Other","conditions":"Limb Ischemia|Diabetic Foot","interventions":[{"intervention_type":"Drug","name":"Drug: High dose allogeneic mesenchymal stromal cells","description":"Allogeneic mesenchymal stromal cells derived from adipose tissue administered intramuscularly"},{"intervention_type":"Drug","name":"Drug: Low dose allogeneic mesenchymal stromal cells","description":"Allogeneic mesenchymal stromal cells derived from adipose tidssue administeres intramuscularly"},{"intervention_type":"Drug","name":"Drug: Placebos","description":"0,9% physiological saline"}],"outcomes":[{"outcome_type":"primary","measure":"Complication rate after treatment administration","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Evaluation of vascularization though RMN","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Rutherford-Becker scale","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Wifi scale","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Ankle arm index","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Temperature","time_frame":"1 year","description":"(ºC)"},{"outcome_type":"secondary","measure":"Twin perimeter","time_frame":"1 year","description":"(cm)"},{"outcome_type":"secondary","measure":"Neuropathic symptoms (altered sensitivity)","time_frame":"1 year"},{"outcome_type":"secondary","measure":"% amputations","time_frame":"1 year"},{"outcome_type":"other","measure":"SF-12 questionnaire","time_frame":"1 year"},{"outcome_type":"other","measure":"VascuQol-6 questionnaire","time_frame":"1 year"}]}
{"nct_id":"NCT04711005","start_date":"2021-01-11","phase":"Phase 1","enrollment":48,"brief_title":"Phase 1 Evaluation of (2R,6R)-Hydroxynorketamine","official_title":"A Double-Blind, Placebo-controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study of the Safety, Pharmacokinetics and Pharmacodynamics of (2R,6R)-Hydroxynorketamine in Healthy Volunteers","primary_completion_date":"2021-11-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-11-30","last_update":"2021-02-02","description":"A 6-cohort single ascending dose (SAD) study will be conducted in healthy volunteers utilizing a slow-infusion intravenous (IV) route of administration. Standard safety, pharmacokinetics (PK) and qEEG monitoring will be evaluated at all dose levels. Subsequently, a 3-cohort multiple ascending dose (MAD) study will be conducted. Doses will be administered on days 1, 4, 7, and 10. Standard safety parameters will be monitored, and PK will be evaluated at all dose levels.","other_id":"HNK-378227-01","allocation":"Randomized","intervention_model":"Sequential Assignment","primary_purpose":"Treatment","masking_description":"Double","intervention_model_description":"A 6-cohort single ascending dose (SAD) study will be conducted in healthy volunteers followed by a 3-cohort multiple ascending dose (MAD) study in healthy volunteers.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Be a healthy male or female between 18 and 65 years of age (inclusive).\r\n\r\n          2. Voluntarily consents to participate in the study and provides written informed consent\r\n             before the start of any study-specific procedures.\r\n\r\n          3. Be willing and able to remain in the study unit for the entire duration of the\r\n             confinement period and return for outpatient visits.\r\n\r\n          4. Agree to comply with prohibitions and restrictions (section 8.5).\r\n\r\n          5. Females must have a negative serum -human chorionic gonadotropin (hCG) pregnancy test\r\n             at screening and a negative urine pregnancy test on Day -1 prior to study initiation.\r\n\r\n          6. Females must be of nonchildbearing potential or agree to use appropriate birth\r\n             control, as defined in section 8.4 Contraception Requirements.\r\n\r\n          7. Males must be surgically sterile for at least 90 days before screening or agree to use\r\n             a condom with spermicide when sexually active with a female partner who is not using\r\n             an acceptable form of birth control during the study and for 90 days after study\r\n             administration. Males must also agree to not donate sperm starting at enrollment and\r\n             for 90 days after last study drug administration.\r\n\r\n          8. BMI (weight [kg]/[m2]) between 18 and 35 kg/m2 (inclusive) and weighs between 50 and\r\n             120 kg (110 - 264 pounds), inclusive.\r\n\r\n          9. Blood pressure (after Subject is in a supine position for approximately 5 minutes)\r\n             between 90 and 145 mmHg systolic (inclusive) and no higher than 90 mmHg diastolic at\r\n             Screening and Day -1.\r\n\r\n         10. A 12-lead ECG with no clinically significant abnormality as judged by the Investigator\r\n             and QTc interval  450 milliseconds at Screening and Day -1.\r\n\r\n         11. Resting pulse rate between 45 and 100 beats per minute at Screening and Day -1.\r\n\r\n         12. Clinical laboratory findings and VS within normal range, or if outside of the normal\r\n             ranges, deemed not clinically significant in the opinion of the Investigator.\r\n\r\n         13. Agree to comply with the rules regarding consumption of alcohol, caffeinated\r\n             beverages, and tobacco/nicotine products during the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. History or presence of clinically significant medical illness including (but not\r\n             limited to) hepatic, cardiovascular, pulmonary, renal, hematologic, endocrine,\r\n             gastrointestinal, immunologic, dermatologic, neurologic, oncologic, or psychiatric\r\n             disease that in the opinion of the Investigator would endanger the safety of the\r\n             Subject or the validity of the study results.\r\n\r\n          2. Clinically significant acute illness in the 2 weeks prior to dosing.\r\n\r\n          3. Previous or current participation in any clinical study with an investigational drug,\r\n             device, or biologic within 30 days or five half-lives of the investigational product\r\n             to dosing.\r\n\r\n          4. Preplanned surgery or procedures that would interfere with the conduct of the study.\r\n\r\n          5. History of severe drug or excipient allergy, or hypersensitivity to be judged at the\r\n             discretion of the Investigator.\r\n\r\n          6. Donation or loss of greater than 0.5 L of blood within 90 days before screening or\r\n             study start. Donation of platelets within 40 days before screening or study start.\r\n             Donation of plasma within 14 days before screening or study start. Receipt of blood\r\n             products within 60 days before screening or study start.\r\n\r\n          7. Recent history (2 years) of alcohol or drug abuse at the discretion of the\r\n             Investigator or a positive screen for alcohol or drugs of abuse (including marijuana)\r\n             at screening and upon check-in.\r\n\r\n          8. Testing positive for hepatitis B, hepatitis C, or HIV, or a history of any of these\r\n             diseases. Subjects whose results are compatible with prior immunization may be\r\n             included at the discretion of the Investigator.\r\n\r\n          9. History of unexplained loss of consciousness, epilepsy, or other seizure disorders, or\r\n             cerebrovascular disease.\r\n\r\n         10. Malignancy within 5 years of screening visit (except basal cell or squamous cell skin\r\n             carcinoma).\r\n\r\n         11. Inability to adhere to the study unit diet.\r\n\r\n         12. Use of any prescription or nonprescription medication (including vitamins, herbal\r\n             preparations, and nutritional supplements) within the 14 days prior to dosing except\r\n             for common analgesics (acetaminophen, ibuprofen), hormonal contraceptives or hormonal\r\n             replacement therapy or nonsedating antihistamines. Topical medications may be allowed\r\n             at the discretion of the Investigator.\r\n\r\n         13. History or current diagnosis of mental illness including (but not limited to)\r\n             psychotic disorder, bipolar disorder, schizophrenia, borderline personality disorder,\r\n             and antisocial personality disorder, generalized anxiety disorder, obsessive\r\n             compulsive disorder, posttraumatic stress disorder, and eating disorders.\r\n\r\n         14. History of suicidal or homicidal ideation.\r\n\r\n         15. Significant primary sleep disorder.\r\n\r\n         16. Known allergy to ketamine, heparin, or any of the IDP components (see section 10.0\r\n             Study Drug Information).\r\n\r\n         17. Any strenuous exercise in the 2 days prior to study drug administration.\r\n\r\n         18. Consumption of beverages or food that contain alcohol, grapefruit, poppy seeds,\r\n             Brussel sprouts, pomegranate, broccoli, char-grilled meat within 2 days prior to drug\r\n             administration. Allowances for a single isolated incidental consumption may be\r\n             evaluated and approved pending PI approval for the potential interactions.\r\n\r\n         19. Use of tobacco or nicotine-containing products within 4 weeks prior to drug\r\n             administration.\r\n\r\n         20. Employee of the PI or study center with direct involvement in the proposed study or\r\n             other studies under the direction of the study PI.\r\n\r\n         21. Poor peripheral venous access.\r\n\r\n         22. Close relative (parent, sibling, child) of clinical site employee.\r\n\r\n         23. Subjects who, in the opinion of the PI or designee, should not participate in this\r\n             study.\r\n      ","sponsor":"National Institute of Mental Health (NIMH)","sponsor_type":"NIH","conditions":"Major Depressive Disorder","interventions":[{"intervention_type":"Drug","name":"Drug: (2R,6R)-Hydroxynorketamine hydrochloride","description":"(2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo will be made up of a 0.9% w/v saline solution (53 mL total volume) administered via slow IV infusion over a 40-minute period."}],"outcomes":[{"outcome_type":"primary","measure":"Number of subjects with adverse events as a measure of safety and tolerability of (2R,6R)-Hydroxynorketamine","time_frame":"8 days post dosing (SAD)","description":"Investigational product-related adverse events and serious adverse events"},{"outcome_type":"primary","measure":"Number of subjects with adverse events as a measure of safety and tolerability of (2R,6R)-Hydroxynorketamine","time_frame":"19 days post dosing (MAD)","description":"Investigational product-related adverse events and serious adverse events"},{"outcome_type":"primary","measure":"Number of subjects with adverse events as a measure of safety and tolerability of (2R,6R)-Hydroxynorketamine","time_frame":"8 days post dosing (SAD)","description":"Vital signs (systolic and diastolic blood pressure, pulse rate, respiration, temperature)"},{"outcome_type":"primary","measure":"Number of subjects with adverse events as a measure of safety and tolerability of (2R,6R)-Hydroxynorketamine","time_frame":"19 days post dosing (MAD)","description":"Vital signs (systolic and diastolic blood pressure, pulse rate, respiration, temperature)"},{"outcome_type":"primary","measure":"Number of subjects with adverse events as a measure of safety and tolerability of (2R,6R)-Hydroxynorketamine","time_frame":"8 days post dosing (SAD)","description":"12 lead electrocardiogram including heart rate, rhythm, RR interval, QT interval, QTcF interval, PR interval, and QRS duration"},{"outcome_type":"primary","measure":"Number of subjects with adverse events as a measure of safety and tolerability of (2R,6R)-Hydroxynorketamine","time_frame":"19 days post dosing (MAD)","description":"12 lead electrocardiogram including heart rate, rhythm, RR interval, QT interval, QTcF interval, PR interval, and QRS duration"},{"outcome_type":"primary","measure":"Number of subjects with adverse events as a measure of safety and tolerability of (2R,6R)-Hydroxynorketamine","time_frame":"8 days post dosing (SAD)","description":"Clinical laboratory assessments (serum chemistry, hematology, urinalysis)"},{"outcome_type":"primary","measure":"Number of subjects with adverse events as a measure of safety and tolerability of (2R,6R)-Hydroxynorketamine","time_frame":"19 days post dosing (MAD)","description":"Clinical laboratory assessments (serum chemistry, hematology, urinalysis)"},{"outcome_type":"primary","measure":"Pharmacokinetics of (2R,6R)-Hydroxynorketamine, maximum plasma concentration (Cmax)","time_frame":"3 days post dosing (SAD), 12 days post dosing (MAD)","description":"This parameter will be calculated as appropriate and if possible for (2R,6R)-Hydroxynorketamine, depending on actual samples collected."},{"outcome_type":"primary","measure":"Pharmacokinetics of (2R,6R)-Hydroxynorketamine, time taken to reach maximum plasma concentration (tmax)","time_frame":"3 days post dosing (SAD), 12 days post dosing (MAD)","description":"This parameter will be calculated as appropriate and if possible for (2R,6R)-Hydroxynorketamine, depending on actual samples collected."},{"outcome_type":"primary","measure":"Pharmacokinetics of (2R,6R)-Hydroxynorketamine, minimum plasma concentration at the end of the dosing interval after each dose in the MAD study (Cmin)","time_frame":"12 days post dosing (MAD)","description":"This parameter will be calculated as appropriate and if possible for (2R,6R)-Hydroxynorketamine, depending on actual samples collected."},{"outcome_type":"primary","measure":"Pharmacokinetics of (2R,6R)-Hydroxynorketamine, area under the curve concentration (AUC)","time_frame":"3 days post dosing (SAD), 12 days post dosing (MAD)","description":"This parameter will be calculated as appropriate and if possible for (2R,6R)-Hydroxynorketamine, depending on actual samples collected."},{"outcome_type":"primary","measure":"Pharmacokinetics of (2R,6R)-Hydroxynorketamine, plasma drug clearance (CL)","time_frame":"3 days post dosing (SAD), 12 days post dosing (MAD)","description":"This parameter will be calculated as appropriate and if possible for (2R,6R)-Hydroxynorketamine, depending on actual samples collected."},{"outcome_type":"primary","measure":"Pharmacokinetics of (2R,6R)-Hydroxynorketamine, renal drug clearance (CLr)","time_frame":"3 days post dosing (SAD), 12 days post dosing (MAD)","description":"This parameter will be calculated as appropriate and if possible for (2R,6R)-Hydroxynorketamine, depending on actual samples collected."},{"outcome_type":"primary","measure":"Pharmacokinetics of (2R,6R)-Hydroxynorketamine, apparent volume of distribution during terminal phase (Vz)","time_frame":"3 days post dosing (SAD), 12 days post dosing (MAD)","description":"This parameter will be calculated as appropriate and if possible for (2R,6R)-Hydroxynorketamine, depending on actual samples collected."},{"outcome_type":"primary","measure":"Pharmacokinetics of (2R,6R)-Hydroxynorketamine, half-life (t1/2)","time_frame":"3 days post dosing (SAD), 12 days post dosing (MAD)","description":"This parameter will be calculated as appropriate and if possible for (2R,6R)-Hydroxynorketamine, depending on actual samples collected."},{"outcome_type":"secondary","measure":"Pharmacodynamics of (2R,6R)-Hydroxynorketamine, quantitative electroencephalography (qEEG) relative spectral power","time_frame":"3 hours post dosing (SAD)","description":"An FFT analysis will be performed on the raw EEG. From this FFT analysis, the absolute and relative power spectrum will be determined across all frequency bands (delta, theta, alpha, beta and gamma)."},{"outcome_type":"secondary","measure":"Pharmacodynamics of (2R,6R)-Hydroxynorketamine, quantitative electroencephalography (qEEG) visual evoked time-locked data","time_frame":"3 hours post dosing (SAD)","description":"Analysis of sensory processing will be conducted through consideration of the visual evoked potential to a contrast reversing checkerboard."},{"outcome_type":"secondary","measure":"Pharmacodynamics of (2R,6R)-Hydroxynorketamine, quantitative electroencephalography (qEEG) source localization","time_frame":"3 hours post dosing (SAD)","description":"Frequency-specific and time-locked source localization will be performed using sLORETA within regions-of-interest specifying Default Mode, Central Executive, and Somatosensory networks."}]}
{"nct_id":"NCT04802668","start_date":"2021-01-09","enrollment":300,"brief_title":"Factors Influencing of Pulse Pressure Variation (PPV)","official_title":"Factors Influencing the Reliability of Pulse Pressure Variation (PPV) as a Predictor of Fluid Responsiveness in Mechanically Ventilated Patients","primary_completion_date":"2022-05-01","study_type":"Observational","rec_status":"Enrolling by invitation","completion_date":"2022-07-01","last_update":"2021-03-19","description":"The investigators studied the predictive value of PPV in the patients with different influencing factors;and the method to improve the predictive value,which can improve the application of PPV in ICU.","other_id":"20210101PPV","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":80,"population":"Patients with circulatory failure selected to enter the Department of Critical Care\r\n        Medicine from December 2020 to May 2022","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients requiring invasive mechanical ventilation\r\n\r\n          -  Acute circulatory failure,defined as:systolic blood pressure <90 mmHg or blood\r\n             pressure in patients with previous hypertension lower than the baseline value> 40\r\n             mmHg; vasoactive drugs are required to maintain blood pressure (mean arterial\r\n             pressure> 65 mmHg); with or without signs of hypoperfusion (oliguria<0.5ml.kg-1.h-1\r\n             for at least 2 hours; arterial blood lactic acid>2.5mmol.L-1; skin mottling)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  The age of the patient is less than 18 years old or more than 80 years old\r\n\r\n          -  Refuse to sign the informed consent to join the group\r\n\r\n          -  Atrial fibrillation and other arrhythmias that seriously affect the output per beat;\r\n\r\n          -  With pregnancy\r\n\r\n          -  Other situations where the clinician believes that the patient is not suitable for\r\n             inclusion in the study\r\n      ","sponsor":"Southeast University, China","sponsor_type":"Other","conditions":"Haemodynamics|Fluid Responsiveness|Pulse Pressure Variation","interventions":[{"intervention_type":"Device","name":"Device: Patients were ventilated with assist-control ventilationA/C mode at different tidal volume :A/C-6ml/kgA/C-8ml/kgA/C-10ml/kg","description":"Ventilation mode was set to assist-control volume ventilation with different tidal volume : 6ml/kg8ml/kg and 10ml/kg; fraction of oxygen (FiO2) 40%-50%, respiratory frequency 15 times/min, PEEP 5centimeter water column."},{"intervention_type":"Behavioral","name":"Behavioral: spontaneous breathing and no spontaneous breathing","description":"Data were recorded when patients had and did not have spontaneous breathing"},{"intervention_type":"Device","name":"Device: Patients were ventilated with pressure support ventilationPSV mode at different pressure support level:PSV1PSV2PSV3","description":"Ventilation mode was set to pressure support ventilation with different pressure support level; fraction of oxygen (FiO2) 40%-50%, respiratory frequency 15 times/min, PEEP 5centimeter water column."}],"outcomes":[{"outcome_type":"primary","measure":"cardiac output(CO)","time_frame":"December.2020-May.2022","description":"The measurement of cardiac output(CO);"},{"outcome_type":"secondary","measure":"measurement of Hemodynamic variables from the monitor;","time_frame":"December.2020-May.2022","description":"The investigators record the hemodynamic variables from the monitor；such as systolic blood pressure (SBP)(mmhg), diastolic blood pressure (DBP)(mmhg), central venous pressure (CVP)(mmhg)."},{"outcome_type":"secondary","measure":"measurement of Pulse pressure variation（PPV）from monitor;","time_frame":"December.2020-May.2022","description":"Pulse pressure variation (PPV)(percent) ,whic is calculated from the systolic and diastolic blood pressure,can be read from the monitor directly."},{"outcome_type":"secondary","measure":"measurement of airway pressure variables from ventilator","time_frame":"December.2020-May.2022","description":"The investigators record the airway pressure variables from the ventilator；such as Peak pressure (P peak)(cmH2O), plateau pressure (Pplat)(cmH2O), positive end expiratory pressure (PEEP)(cmH2O),the airway occlusion pressure at 100 milliseconds after the onset of inspiration (P0.1)(cmH2O) in different interventions."}]}
{"nct_id":"NCT04355780","start_date":"2021-01-08","enrollment":40,"brief_title":"Immunologic Features of Respiratory Failure in Pediatric Hematopoietic Cell Transplantation (HCT) Recipients and Pediatric Oncology Patients","official_title":"Immunologic Features of Respiratory Failure in Pediatric Hematopoietic Cell Transplantation (HCT) Recipients and Pediatric Oncology Patients","primary_completion_date":"2024-05-30","study_type":"Observational","rec_status":"Recruiting","completion_date":"2025-05-30","last_update":"2021-03-26","description":"This study is being done because researchers want to learn more about genes that control the immune response in the participant's lungs and blood when the participant have lung disease leading to respiratory failure. Primary Objective To evaluate the feasibility of performing single cell gene expression analyses on tracheal aspirates from immunocompromised pediatric patients with immune compromising conditions, including HCT recipients. Secondary Objectives - To assess whether cell composition and activation states in longitudinally obtained tracheal aspirate and blood samples are able to distinguish unique immunopathology for each of the early post-HCT lung diseases. - To assess whether cell composition and activation states in longitudinally obtained tracheal aspirate and blood samples are different between two immunodeficient patient populations (alloHCT vs non alloHCT) with lung disease and respiratory failure. - To test the hypothesis that allogeneic T cell responses are implicated in the pathogenesis of early post-HCT lung diseases. Exploratory Objectives To correlate immune cell signaling in the lower respiratory tract and blood of patients with early post-HCT lung diseases with the presence or absence of pathogenic microbes at each site. To explore HLA testing in Tracheal Aspirates in samples where enough cells are present.","other_id":"HCTALI","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","maximum_age":21,"population":"All participants who meet eligibility criteria and consent to enrollment on the study.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Participant is age 0 to 21 years old\r\n\r\n          -  Participant has acute respiratory failure due to primary pulmonary disease and is\r\n             expected to receive invasive mechanical ventilation for more than 48 hours\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  The primary etiology of respiratory failure is not related to primary pulmonary\r\n             disease\r\n\r\n          -  Aspiration is present\r\n\r\n          -  The participant has a tracheostomy\r\n\r\n          -  If the patient has undergone HCT, they are more than 100 days removed from HCT\r\n\r\n          -  Has a diagnosis of severe combined immunodeficiency syndrome (SCIDS)\r\n\r\n          -  The primary on-service team feels obtaining a study sample would be unsafe for any\r\n             reason.\r\n\r\n          -  Inability or unwillingness of research participant or legal guardian/representative to\r\n             give written informed consent.\r\n      ","sponsor":"St. Jude Children's Research Hospital","sponsor_type":"Other","conditions":"Respiratory Failure|Respiratory Disease","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Feasibility of performing single cell gene expression analyses on tracheal aspirates","time_frame":"4 years","description":"Feasibility is a qualitative binary outcome (Yes and No), based on the success of recovery of more than 100,000 live cells from a tracheal aspirate and blood sample from five of the first ten allo HCT patients enrolled on the study protocol."},{"outcome_type":"secondary","measure":"Success of distinguishing unique immunopathology for each of the early post-HCT lung diseases","time_frame":"4 years","description":"This is a qualitative binary outcome (Yes/No) by applying single cell gene expression analyses to cells from tracheal aspirates and blood of patients with post-HCT lung diseases. With visualization techniques, a call of success (Yes/No) will be made."},{"outcome_type":"secondary","measure":": Difference of cell composition and activation states between two immunodeficient patient populations (alloHCT vs non alloHCT) with lung disease and respiratory failure.","time_frame":"4 years","description":"This is a qualitative binary outcome (different vs not different) obtained from visualization."},{"outcome_type":"secondary","measure":"Whether allogeneic T cell responses are implicated in the pathogenesis of early post-HCT lung diseases.","time_frame":"4 years","description":"This is a qualitative binary endpoint assessed by visualization."}]}
{"nct_id":"NCT04733014","start_date":"2021-01-07","enrollment":200,"brief_title":"Perceptions of Ophthalmologists Regarding Contemporary Presbyopia Management.","official_title":"Perceptions of Greek Ophthalmologists Regarding Contemporary Presbyopia Management.","primary_completion_date":"2021-02-07","study_type":"Observational","rec_status":"Recruiting","completion_date":"2021-02-07","last_update":"2021-02-01","description":"Different attitudes and perceptions are encountered concerning contemporary presbyopia management. Exploration of ophthalmologists' attitudes on diagnostic and therapeutic management of presbyopia is essential for the development of disease management interventions by the Hellenic Ministry of Health and Welfare. Within this context, Greek ophthalmologists' perceptions on presbyopia will be explored by means of a custom questionnaire.","other_id":"ES1/Th3/21-1-2021","observational_model":"Other","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":30,"population":"Our study's sample will be representative in terms of age, gender, geographic location.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Valid license to practice ophthalmology in European Union.\r\n\r\n          -  Adequate literacy of Greek language.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pediatric ophthalmologist.\r\n      ","sponsor":"Democritus University of Thrace","sponsor_type":"Other","conditions":"Presbyopia","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Perceptions on presbyopia","time_frame":"1 month","description":"Greek ophthalmologists' attitudes on contemporary presbyopia management"}]}
{"nct_id":"NCT04738435","start_date":"2021-01-05","enrollment":600,"brief_title":"Safety of the Sputnik V Vaccine in Health Personnel of Private Effectors of the City of Buenos Aires, Argentina","official_title":"Safety of the Sputnik V Vaccine in Health Personnel of Private Effectors of the City of Buenos Aires, Argentina","primary_completion_date":"2021-03-01","study_type":"Observational","rec_status":"Completed","completion_date":"2021-03-01","last_update":"2021-08-25","description":"The main of the study is to describe the incidence in health personnel who present events supposedly attributed to vaccines and immunizations after having received the two components of the Sputnik V vaccine, with the information obtained thanks to the participation of health workers in actively reporting their health status.","other_id":"3876","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"health workers","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  health workers who agree to receive the sputnik V vaccine\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  health workers who have a contraindication to receive the sputnik V vaccine\r\n      ","sponsor":"Hospital Italiano de Buenos Aires","sponsor_type":"Other","conditions":"COVID-19","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Incidence of events supposedly attributed to vaccines and immunizations after Sputnik V","time_frame":"From first doses up to 10 days","description":"Incidence of events supposedly attributed to vaccines and immunizations after the fist and second doses of Sputnik V in in health personnel"}]}
{"nct_id":"NCT04659096","start_date":"2021-01-05","phase":"Phase 1","enrollment":102,"brief_title":"A Study of ION537 in Patients With Molecularly Selected Advanced Solid Tumors","official_title":"Phase 1 Trial of ION537 in Patients With Molecularly Selected Advanced Solid Tumors","primary_completion_date":"2023-06-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-06-30","last_update":"2021-01-07","description":"The purpose of this study is to evaluate the safety and establish the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of ION537 when administered by intravenous infusion in patients with advanced solid tumors.","other_id":"ION537-CS1","allocation":"N/A","intervention_model":"Sequential Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Males and females  18 years old\r\n\r\n          2. Participants must have histological diagnosis of local advanced (primary or recurrent)\r\n             or metastatic solid tumors that are not amenable for treatment with curative intent\r\n\r\n          3. Participants must be in need of systemic treatment for their cancer and either are\r\n             refractory to or have failed treatment with, are intolerant to or have refused, or are\r\n             not otherwise a candidate, in the opinion of the Investigator, for any of the\r\n             currently available established therapies\r\n\r\n          4. Participants must have available a fresh or recent tumor tissue sample from a\r\n             diagnostic biopsy/surgery or a metastatic tumor biopsy;\r\n\r\n          5. Participants must have measurable disease by response evaluation criteria in solid\r\n             tumors (RECIST) v1.1; or participants may have bone metastatic disease evaluable by\r\n             Prostate Cancer Working Group 2 (PCWG2) for participants with metastatic\r\n             castration-resistant prostate cancer (mCRPC), or according to the tumor evaluation\r\n             criteria best suited and accepted for the tumor type being evaluated\r\n\r\n          6. Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status\r\n             (PS) 0 or 1\r\n\r\n          7. Participants must be willing and able to comply with the scheduled visits, treatment\r\n             plan, laboratory tests and other specified study procedures\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Known history or positive test for human immunodeficiency virus (HIV), hepatitis C\r\n             virus (HCV) or chronic hepatitis B virus (HBV) infection.\r\n\r\n          2. Active infection requiring intravenous (IV) antibiotics\r\n\r\n          3. History of cerebrovascular accident (CVA), myocardial infarction or unstable angina\r\n             within the previous 6 months before starting therapy.\r\n\r\n          4. Participants with uncontrolled Type I or II diabetes mellitus (DM); uncontrolled DM\r\n\r\n          5. Participants with prior anti-cancer therapy within 2 weeks prior to study enrollment\r\n             or prior radiation therapy within 2 weeks prior to study enrollment.\r\n      ","sponsor":"Ionis Pharmaceuticals, Inc.","sponsor_type":"Industry","conditions":"Advanced Solid Tumors","interventions":[{"intervention_type":"Drug","name":"Drug: ION537","description":"ION537 will be administered by IV injection."}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Treatment-emergent Serious Adverse Event (TESAE), Graded by Severity","time_frame":"Up to disease progression, death, start of new anticancer treatment, withdrawal of consent to study participation or end of the study, whichever occurs first (up to approximately 24 weeks for analysis)"},{"outcome_type":"primary","measure":"Number of Participants With Dose-limiting Toxicities (DLTs)","time_frame":"Up to disease progression, death, start of new anticancer treatment, withdrawal of consent to study participation or end of the study, whichever occurs first (up to approximately 24 weeks for analysis)"},{"outcome_type":"primary","measure":"Percentage of Participants With Complete Response (CR)","time_frame":"Up to disease progression, death, start of new anticancer treatment, withdrawal of consent to study participation or end of the study, whichever occurs first (up to approximately 24 weeks for analysis)"},{"outcome_type":"primary","measure":"Percentage of Participants With Partial Response (PR)","time_frame":"Up to disease progression, death, start of new anticancer treatment, withdrawal of consent to study participation or end of the study, whichever occurs first (up to approximately 24 weeks for analysis)"},{"outcome_type":"primary","measure":"Percentage of Participants With Stable Disease (SD)","time_frame":"Up to disease progression, death, start of new anticancer treatment, withdrawal of consent to study participation or end of the study, whichever occurs first (up to approximately 24 weeks for analysis)"},{"outcome_type":"primary","measure":"Area Under the Plasma Concentration-Time Curve from Hour Zero to Hour 24 AUC[0-24] for ION537","time_frame":"Up to disease progression, death, start of new anticancer treatment, withdrawal of consent to study participation or end of the study, whichever occurs first (up to approximately 24 weeks for analysis)"},{"outcome_type":"primary","measure":"Maximum Observed Plasma Concentration (Cmax) for ION537","time_frame":"Up to disease progression, death, start of new anticancer treatment, withdrawal of consent to study participation or end of the study, whichever occurs first (up to approximately 24 weeks for analysis)"},{"outcome_type":"primary","measure":"Inhibition of Yes-associated Protein (YAP1) Expression","time_frame":"Up to disease progression, death, start of new anticancer treatment, withdrawal of consent to study participation or end of the study, whichever occurs first (up to approximately 24 weeks for analysis)"},{"outcome_type":"secondary","measure":"Percentage of Participants With CR","time_frame":"Up to disease progression, death, start of new anticancer treatment, withdrawal of consent to study participation or end of the study, whichever occurs first (up to approximately 24 weeks for analysis)"},{"outcome_type":"secondary","measure":"Percentage of Participants With PR","time_frame":"Up to disease progression, death, start of new anticancer treatment, withdrawal of consent to study participation or end of the study, whichever occurs first (up to approximately 24 weeks for analysis)"},{"outcome_type":"secondary","measure":"Percentage of Participants With SD","time_frame":"Up to disease progression, death, start of new anticancer treatment, withdrawal of consent to study participation or end of the study, whichever occurs first (up to approximately 24 weeks for analysis)"},{"outcome_type":"secondary","measure":"Clinical Benefit Rate (CBR)","time_frame":"Up to disease progression, death, start of new anticancer treatment, withdrawal of consent to study participation or end of the study, whichever occurs first (up to approximately 24 weeks for analysis)"},{"outcome_type":"secondary","measure":"Objective Response Rate (ORR)","time_frame":"Up to disease progression, death, start of new anticancer treatment, withdrawal of consent to study participation or end of the study, whichever occurs first (up to approximately 24 weeks for analysis)"},{"outcome_type":"secondary","measure":"Duration of Response (DoR)","time_frame":"Up to disease progression, death, start of new anticancer treatment, withdrawal of consent to study participation or end of the study, whichever occurs first (up to approximately 24 weeks for analysis)"},{"outcome_type":"secondary","measure":"Progression-free Survival (PFS)","time_frame":"Up to disease progression, death, start of new anticancer treatment, withdrawal of consent to study participation or end of the study, whichever occurs first (up to approximately 24 weeks for analysis)"},{"outcome_type":"secondary","measure":"Overall Survival (OS)","time_frame":"Up to disease progression, death, start of new anticancer treatment, withdrawal of consent to study participation or end of the study, whichever occurs first (up to approximately 24 weeks for analysis)"},{"outcome_type":"secondary","measure":"Area Under the Plasma Concentration-Time Curve from Hour Zero to Hour 24 AUC[0-24] for ION537","time_frame":"Up to disease progression, death, start of new anticancer treatment, withdrawal of consent to study participation or end of the study, whichever occurs first (up to approximately 24 weeks for analysis)"},{"outcome_type":"secondary","measure":"Maximum Observed Plasma Concentration (Cmax) for ION537","time_frame":"Up to disease progression, death, start of new anticancer treatment, withdrawal of consent to study participation or end of the study, whichever occurs first (up to approximately 24 weeks for analysis)"},{"outcome_type":"secondary","measure":"Time to Reach the Maximum Plasma Concentration (Tmax) for ION537","time_frame":"Up to disease progression, death, start of new anticancer treatment, withdrawal of consent to study participation or end of the study, whichever occurs first (up to approximately 24 weeks for analysis)"},{"outcome_type":"secondary","measure":"Elimination Half-Life (t1/2) of ION537","time_frame":"Up to disease progression, death, start of new anticancer treatment, withdrawal of consent to study participation or end of the study, whichever occurs first (up to approximately 24 weeks for analysis)"}]}
{"nct_id":"NCT04634253","start_date":"2021-01-04","phase":"Phase 2","enrollment":80,"brief_title":"A Study of LY3462817 in Participants With Rheumatoid Arthritis","official_title":"A Phase 2 Study to Evaluate the Efficacy and Safety of LY3462817 in Participants With Moderately to Severely Active Rheumatoid Arthritis","primary_completion_date":"2022-02-03","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-07-15","last_update":"2021-09-21","description":"The reason for this study is to see if the study drug LY3462817 is safe and effective in participants with moderately to severely active rheumatoid arthritis (RA).","other_id":"17424","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Have a diagnosis of adult onset RA as defined by the 2010 American College of\r\n             Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria\r\n             for at least 3 months prior to screening\r\n\r\n          -  Have moderately to severely active RA defined by the presence of 6 swollen joints\r\n             (based on 66 joint count) and 6 tender joints (based on 68 joint count) at screening\r\n             and baseline. The distal interphalangeal joint should be evaluated but not included in\r\n             the total count to determine eligibility\r\n\r\n          -  Have at least 1 of the following:\r\n\r\n               -  positive test results for rheumatoid factor or anti-citrullinated peptide\r\n                  antibodies at screening, OR\r\n\r\n               -  previous radiographs documenting bony erosions in hands or feet consistent with\r\n                  RA\r\n\r\n          -  Have C-reactive protein (CRP) >1.2 times upper limit of normal (ULN) per the central\r\n             laboratory at screening\r\n\r\n          -  Demonstrated an inadequate response to, or loss of response or intolerance to:\r\n\r\n               -  at least 1 conventional synthetic disease-modifying antirheumatic drug (csDMARD)\r\n                  treatment OR\r\n\r\n               -  at least 1 biologic DMARD/tsDMARD treatment\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Class IV RA according to ACR revised response criteria\r\n\r\n          -  Have a diagnosis or history of malignant disease within 5 years prior to baseline,\r\n             with the exceptions of:\r\n\r\n               -  basal cell or squamous epithelial carcinomas of the skin that have been resected\r\n                  with no evidence of metastatic disease for 3 years, or\r\n\r\n               -  cervical carcinoma in situ, with no evidence of recurrence within the 5 years\r\n                  prior to baseline\r\n\r\n          -  Have presence of confirmed cervical dysplasia\r\n\r\n          -  Have had various types of infection within 3 months of screening or develops any of\r\n             these infections before the randomization visit.\r\n\r\n          -  Have any of the following:\r\n\r\n               -  Human immunodeficiency virus (HIV) infection\r\n\r\n               -  Current infection with hepatitis B virus (HBV) (i.e., positive for hepatitis B\r\n                  surface antigen and/or polymerase chain reaction (PCR) positive for HBV DNA\r\n\r\n               -  Current infection with hepatitis C virus (HCV) (i.e., positive for HCV RNA)\r\n\r\n               -  Active tuberculosis (TB)\r\n\r\n          -  Have failed more than 2 biologic DMARDs (bDMARDs) or tsDMARDs (e.g. excluded if have\r\n             received 2 bDMARDs and 1 tsDMARD)\r\n      ","sponsor":"Eli Lilly and Company","sponsor_type":"Industry","conditions":"Rheumatoid Arthritis","interventions":[{"intervention_type":"Drug","name":"Drug: Placebo","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: LY3462817","description":"Given IV"}],"outcomes":[{"outcome_type":"primary","measure":"Change from Baseline on the Disease Activity Score Modified to Include the 28 Diarthrodial Joint Count-High-Sensitivity C-Reactive Protein (DAS28-hsCRP)","time_frame":"Baseline, Week 12","description":"DAS28 consists of a composite score of the following variables: tender joint count out of 28 (TJC28), swollen joint count out of 28 (SJC28), hsCRP [milligrams per liter (mg/L)], and Patient's Global Assessment of Disease Activity (PaGADA_VAS) on a 0 to 100 millimeter (mm) VAS (0=very well to 100=very poor). A decrease in DAS28-CRP indicates an improvement in participant's condition."},{"outcome_type":"secondary","measure":"Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20), (ACR50) and (ACR70)","time_frame":"Week 12","description":"ACR responders are participants with at least 20%, 50% and 70% improvement from baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: Health Assessment Questionnaire-Disability Index (HAQ-DI) which measures participants perceived degree of difficulty performing daily activities, acute phase reactant as measured by hsCRP, Patient's Assessment of Pain-Visual Analog Scale (Pain-VAS), Patient's Global Assessment of Disease Activity (PaGADA_VAS), and Physician's Global Assessment of Disease Activity (PhGADA_VAS)."},{"outcome_type":"secondary","measure":"Change from Baseline for Mean Simplified Disease Activity Index (SDAI)","time_frame":"Baseline, Week 12","description":"The SDAI is the numerical sum of 5 outcome parameters: TJC28, SJC28, patient and physician global assessment of disease activity and CRP. Lower SDAI values indicate lower disease activity."},{"outcome_type":"secondary","measure":"Change from Baseline for Mean Clinical Disease Activity Index (CDAI)","time_frame":"Baseline, Week 12","description":"The CDAI measures disease activity in RA. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-100 mm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-100 mm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. Lower CDAI scores indicate lower disease activity. A negative change from baseline indicates improvement in condition."},{"outcome_type":"secondary","measure":"Change from Baseline on the 36 Item Short Form Health Survey (SF-36)","time_frame":"Baseline, Week 12","description":"The SF-36 is a health-related survey that assesses participant's health status and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health, mental health, social functioning, and vitality. The 8 domains are combined to form 2 component scores mental (MCS) and physical (PCS). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status."},{"outcome_type":"secondary","measure":"Pharmacokinetics (PK): Observed Concentration of LY3462817","time_frame":"Week 12","description":"PK: Observed Concentration of LY3462817"}]}
{"nct_id":"NCT04553939","start_date":"2021-01-04","phase":"Phase 2","enrollment":50,"brief_title":"Neoadjuvant Toripalimab in Combination With Gemcitabine Therapy in Cisplatin Ineligible Local Advanved Bladder Cancer","official_title":"Phase II Study of Neoadjuvant Toripalimab in Combination With Gemcitabine Therapy in Cisplatin Ineligible Stage II-IIIB Bladder Cancer","primary_completion_date":"2023-05-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-12-31","last_update":"2021-03-01","description":"This is a pre-surgical study involving subjects with muscle invasive bladder urothelial cancer, who are candidates for cisplatin ineligible neoadjuvant therapy. It is a one-arm phase II study in single center.","other_id":"2020051314","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Be willing and able to provide written informed consent for the trial.\r\n\r\n          -  18-75 years of age on day of signing informed consent.\r\n\r\n          -  Have histologically confirmed muscle invasive disease of the urinary bladder.\r\n\r\n          -  Histology must be urothelial carcinoma (transitional cell carcinoma) or urothelial\r\n             carcinoma with mixed histology/features.\r\n\r\n          -  Clinical stage II-IIIB and Have a surgical evaluation that documents the plan for\r\n             multimodality therapy with a consolidative radical cystectomy.\r\n\r\n          -  ECOG 0-1 and good organ function.\r\n\r\n          -  cisplatin ineligible.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  A non-surgical approach recommended by the treating urologist due to any reason.\r\n\r\n          -  Is currently participating in or has participated in a study of an investigational\r\n             agent or using an investigational device within 28 days prior to study registration.\r\n\r\n          -  Has a diagnosis of immunodeficiency or received systemic steroid therapy or any other\r\n             form of immunosuppressive therapy within 7 days prior to study registration.\r\n\r\n          -  Has a known additional malignancy that is progressing or required treatment  48\r\n             months of study registration. Exceptions include basal cell carcinoma of the skin,\r\n             squamous cell carcinoma of the skin, in situ cervical cancer.\r\n\r\n          -  Has known active central nervous system (CNS) metastases and/or carcinomatous\r\n             meningitis.\r\n\r\n          -  Has an active autoimmune disease requiring systemic treatment.\r\n\r\n          -  Has known evidence of interstitial lung disease or active, non-infectious pneumonitis.\r\n\r\n          -  Has an active infection requiring systemic therapy.\r\n\r\n          -  Has a history or current evidence of any condition, therapy, or laboratory abnormality\r\n             that might confound the results of the trial, interfere with the subject's\r\n             participation for the full duration of the trial, or is not in the best interest of\r\n             the subject to participate, in the opinion of the treating investigator\r\n\r\n          -  Has known psychiatric or substance abuse disorders that would interfere with\r\n             cooperation with the requirements of the trial.\r\n\r\n          -  Is pregnant or breastfeeding, or expecting to conceive or father children within the\r\n             projected duration of the trial, starting with the pre-screening or screening visit\r\n             through 120 days after the last dose of trial treatment.\r\n\r\n          -  Has received prior therapy with an anti-PD-1, anti-PD-L1, antibody.\r\n\r\n          -  Has a known history of Human Immunodeficiency Virus.\r\n\r\n          -  Has known active Hepatitis B or Hepatitis C.\r\n      ","sponsor":"Henan Cancer Hospital","sponsor_type":"Other","conditions":"Urothelial Carcinoma|Bladder Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Toripalimab","description":"Toripalimab 3mg/m2 ivgtt, D1 every 14 days for 2-4 cycles."},{"intervention_type":"Drug","name":"Drug: Gemcitabine","description":"Gemcitabine 800mg/m2 ivgtt, D1 every 14 days for 2-4 cycles."}],"outcomes":[{"outcome_type":"primary","measure":"ORR，objective response rate","time_frame":"3 years","description":"ORR was defined as the percentage of participants in the analysis population who have a CR (disappearance of all target lesions) or a PR (≥30% decrease in the sum of diameters of target lesions) based upon RECIST 1.1."}]}
{"nct_id":"NCT04023604","start_date":"2021-01-04","phase":"N/A","enrollment":35,"brief_title":"Antimicrobial-free Production of Beef Cattle's Affect on Gut Microbiome","official_title":"Does Antimicrobial-free Production of Beef Cattle Reduce Foodborne Transmission of Resistant Bacteria to Human Consumers?","primary_completion_date":"2022-08-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-09-30","last_update":"2021-03-24","description":"The primary purpose of this study is to assess whether consuming foods from animals raised with antimicrobial medications influences gut health in adults between the ages of 21-69 years old. Antimicrobial medications are commonly used to help animals avoid infections while growing.","other_id":"1905022180","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Other","masking_description":"Single","intervention_model_description":"This is a 16-week randomized, cross-over, controlled, blinded study. During weeks 2 and 9, participants usual, unrestricted dietary intakes will be assessed. At week 3 the participants will be randomized and assigned to consume either the controlled U.S. Healthy Eating Pattern with beef produced in conventional systems or to an identical controlled U.S. Healthy Eating Patter with beef produced in RWA (raised without antibiotics) systems. Week 10 will be the second 3- week long dietary intervention period. A total of 14 stool samples will be collected during the study (two after baseline, washout 1 and washout 2, and 4 during the two dietary interventions). Two fasting state serum samples and a psychological questionnaire will be collected during study weeks 2, 5, 9, and 12.","sampling_method":"","gender":"All","minimum_age":21,"maximum_age":69,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female, 21-69 years old;\r\n\r\n          -  BMI 22.0-34.9 kg/m2;\r\n\r\n          -  Fasting serum total cholesterol <240 mg/dL, low-density lipoprotein cholesterol <160\r\n             mg/dL, triglycerides <400 mg/dL, and glucose <110 mg/dL;\r\n\r\n          -  Systolic/diastolic blood pressure <140/90 mmHg;\r\n\r\n          -  Body weight stable ( 4 kg in previous 3 mo);\r\n\r\n          -  Medication use stable for 6 months prior and not using medications or supplements\r\n             known to impact gut function;\r\n\r\n          -  No use of topical, oral or parenteral antibiotic medications in previous 6 months.\r\n\r\n          -  Non-smoking;\r\n\r\n          -  Physical activity regimen stable for 3 months prior;\r\n\r\n          -  Not drinking more than 2 alcoholic drinks per day;\r\n\r\n          -  No history of gastrointestinal disorders, surgeries or cancers;\r\n\r\n          -  Non-pregnant and not lactating\r\n\r\n          -  No acute illness and non-diabetic;\r\n\r\n          -  Willing and able to consume the prescribed diets that may include meat, dairy and\r\n             gluten-containing foods and beverages.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Male or female, < 20 or >70 years old;\r\n\r\n          -  BMI < 21.9- >35 kg/m2;\r\n\r\n          -  Fasting serum total cholesterol >240 mg/dL, low-density lipoprotein cholesterol >160\r\n             mg/dL, triglycerides >400 mg/dL, and glucose >110 mg/dL;\r\n\r\n          -  Systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg;\r\n\r\n          -  Body weight stable for < 3 months prior (3 kg);\r\n\r\n          -  Stable physical activity regimen < 3 months prior;\r\n\r\n          -  Medication use unstable for 6 months prior and using medications or supplements known\r\n             to impact gut function;\r\n\r\n          -  Smoking;\r\n\r\n          -  Drinking more than 2 alcoholic drinks per day;\r\n\r\n          -  Diabetic;\r\n\r\n          -  A history of gastrointestinal disorders, GI surgeries or GI cancers;\r\n\r\n          -  Pregnant or lactating\r\n      ","sponsor":"Purdue University","sponsor_type":"Other","conditions":"Diet Modification","interventions":[{"intervention_type":"Other","name":"Other: Controlled diet with beef raised without antibiotics","description":"The controlled diet with beef raised without antibiotics will follow the Dietary Guidelines for American's recommendations. All foods and beverages will be provided during intervention to achieve the desired eating pattern. Beef included in this diet were raised without antibiotics."},{"intervention_type":"Other","name":"Other: Controlled diet with beef produced in conventional systems","description":"The controlled diet with beef raised without antibiotics will follow the Dietary Guidelines for American's recommendations. All foods and beverages will be provided during intervention to achieve the desired eating pattern. Beef included in this diet were raised with antibiotics."}],"outcomes":[{"outcome_type":"primary","measure":"Differences in the resistome and microbiome","time_frame":"2 years","description":"The resistome and microbiome of rinsates will be obtained from dietary components, and feces collected from the particpants. Researchers will sequence all of the published AMR genes. Microbiome data will be obtained from 16s rRNA gene sequencing to produce amplicons of the V4 region of 16S rRNA genes. Statistical analyses will be conducted of microbial features to assess whether microbial/resistome communities diverge between the two groups. Additionally, foodborne transmission of AMR genes with discriminatory SNP(\"DNA fingerprints\") profiles will be investigated through the food chain into dietary trial participants to identify highly discriminatory patterns in individual genes, or discriminatory profiles in gene sets. Hypothesis: beef is not a significant source of resistant bacteria and there is no difference in the likelihood of gut colonization with resistant bacteria in people eating beef derived from cattle raised conventionally vs beef produced in RWA systems"},{"outcome_type":"secondary","measure":"Level of fasting blood pressure","time_frame":"2 years","description":"The hypothesis is that there is no difference in blood pressure in people eating beef derived from cattle raised conventionally vs. those eating beef produced in RWA systems."},{"outcome_type":"secondary","measure":"Level of fasting serum insulin","time_frame":"2 years","description":"The hypothesis is that there is no difference in fasting serum insulin in people eating beef derived from cattle raised conventionally vs. those eating beef produced in RWA systems."},{"outcome_type":"secondary","measure":"Level of fasting serum glucose","time_frame":"2 years","description":"The hypothesis is that there is no difference in fasting serum glucose in people eating beef derived from cattle raised conventionally vs. those eating beef produced in RWA systems."},{"outcome_type":"secondary","measure":"Size of lipoprotein particle","time_frame":"2 years","description":"The hypothesis is that there is no difference in lipoprotein particle size in people eating beef derived from cattle raised conventionally vs. those eating beef produced in RWA systems"},{"outcome_type":"other","measure":"Questionnaire score of mood and health and well being","time_frame":"2 years","description":"The POMS (Profile of Mood States) Questionnaire is a psychological rating scale to assess distinct mood states. There is a total of 35 questions using a five point scale ranging from \"not at all\" to \"extremely\" indicating the range of mood swings over a period of time.\r\nThe Optum SF-36v2 (Short Form 36 question Version 2) Health Survey measures the functional health and wellbeing of a participant. SF-36v2 consists of eight scaled scores which are the weighted sums of the questions in their section. Each scale is transformed into a 0-100 scales, with the assumption that each questions carries equal weight (the lower the score the more disability, the higher the score the less disability).\r\nThe hypothesis is that there is no difference in mood and health and wellbeing in people eating beef derived from cattle raised conventionally vs. those eating beef produced in RWA systems."}]}
{"nct_id":"NCT04929522","start_date":"2021-01-01","phase":"N/A","enrollment":160,"brief_title":"Success Rate of 4 Injection Protocols for Mandibular First Molars With Symptomatic Irreversible Pulpitis","official_title":"Success Rate of 4 Injection Protocols for Mandibular First Molars With Symptomatic Irreversible Pulpitis: A CONSORT Randomized Triple-blind Clinical Trial","primary_completion_date":"2021-05-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2021-05-30","last_update":"2021-06-18","description":"Achieving profound anesthesia during endodontic treatment of mandibular molars with symptomatic irreversible pulpitis is still a demanding clinical challenge. therefore, the success Rate of 4 Injection protocols for Mandibular First Molars with Symptomatic Irreversible Pulpitis was evaluated clinically in a randomized triple-blind trial","other_id":"772019","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","intervention_model_description":"This study was a prospective, randomized, parallel, triple blinded, clinical trial.","sampling_method":"","gender":"All","minimum_age":21,"maximum_age":49,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients included in the study were healthy males and females (Category: American\r\n             Society of Anesthesiologists class 1) aged 21-49 years, with no physical disability,\r\n             facial paresthesia or psychological problems, presenting with a single vital mature\r\n             mandibular first molar, with signs and/or symptoms of symptomatic irreversible\r\n             pulpitis\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnant women, patients who took analgesics or other medications that would alter the\r\n             inflammatory response of the pulp or provide analgesia 6- hours pre-operatively, those\r\n             with known sensitivity to the pharmaceuticals used in this trial. Also, those with\r\n             pathological periodontal pockets\r\n      ","sponsor":"Ain Shams University","sponsor_type":"Other","conditions":"Root Canal Infection","interventions":[{"intervention_type":"Procedure","name":"Procedure: local anesthesia","description":"technique for local anesthesia"}],"outcomes":[{"outcome_type":"primary","measure":"successful injection technique","time_frame":"15 minutes from delivery of anesthesia","description":"the patients were asked to rate their pain using a visual analogue scale (VAS). Pain was scored as follows: Score 0, no pain; Score 1, mild pain; Score 2, moderate pain; or Score 3, severe pain. After rubber dam placement and during caries removal, access preparation and pulpectomy, success of the anesthetic technique was determined by VAS. The technique was considered as a 'success' when the patient reported no pain (VAS = 0 or 1) and as a 'failure' otherwise (VAS >1)."}]}
{"nct_id":"NCT04451681","start_date":"2021-01-01","phase":"N/A","enrollment":84,"brief_title":"Evaluation of Physical Performance in Ankylosing Spondylitis Patients","official_title":"Evaluation of Physical Performance in Ankylosing Spondylitis Patients by Cardiopulmonary Exercise Test","primary_completion_date":"2021-12-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-05-01","last_update":"2021-01-27","description":"Ankylosing spondylitis (AS) can cause serious limitations in individuals' physical performance, as it involves the musculoskeletal system and can cause ankylosis and arthritis in both axial and peripheral joints. Although there are many studies showing these limitations nowadays, there is a need to show these limitations with more objective data with the new technology. Evaluating aerobic physical capacity; Cardiopulmonary Exercise Test (KPET) is frequently used in physical performance analysis today. In this study, the investigators want to observe the physical performance differences between 42 AS patients and 42 control group participants by applying KPET and present the expected performance losses in AS patients in the literature with objective data.","other_id":"BVUFTRAS1","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Screening","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Clinical diagnosis of AS with modified New York Criteria (for AS group)\r\n\r\n          -  Being between the ages of 18-65\r\n\r\n          -  Agree to participate in the study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Cardiac disease\r\n\r\n          -  History of stroke\r\n\r\n          -  Asthma or chronic obstructive pulmonary disease\r\n\r\n          -  Deformity that may prevent exercise\r\n\r\n          -  Hypertension\r\n\r\n          -  Unwilling to participate in the study\r\n      ","sponsor":"Bezmialem Vakif University","sponsor_type":"Other","conditions":"Ankylosing Spondylitis","interventions":[{"intervention_type":"Other","name":"Other: Cardiopulmonary exercise test","description":"Data such as oxygen consumption, cardiac parameters and speed of the patient are analyzed numerically on the treadmill in the KPET; Objective performance values such as maximum oxygen use (VO2max), maximum heart rate, respiratory capacity, and maximum rate will be obtained."}],"outcomes":[{"outcome_type":"primary","measure":"36-Item Short Form Health Survey (SF-36)","time_frame":"Ten minutes","description":"The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The eight sections are:\r\nvitality,physical functioning,bodily pain,general health perceptions,physical role,functioning,emotional role functioning,social role functioning and mental health."},{"outcome_type":"primary","measure":"Bath Ankylosing Spondylitis Disease Activation Index (BASDAI)","time_frame":"Ten minutes","description":"The BASDAI or Bath Ankylosing Spondylitis Disease Activity Index is a validated diagnostic test which allows a physician, usually a rheumatologist, to determine the effectiveness of a current drug therapy, or the need to institute a new drug therapy for the treatment of Ankylosing spondylitis (AS).The BASDAI consists of a 0 - 10 scale measuring discomfort, pain, and fatigue (0 being no problem and 10 being the worst problem) in response to six questions asked of the patient pertaining to the five major symptoms of AS:Fatigue, Spinal pain, Arthralgia (joint pain) or swelling, Enthesitis,Morning stiffness duration, Morning stiffness severity"},{"outcome_type":"primary","measure":"Maximum Oxygen use (VO2max)","time_frame":"60 minutes","description":"VO2 max is the maximum rate of oxygen consumption measured during incremental exercise; that is, exercise of increasing intensity.\r\nThe measurement of VO2 max in the laboratory provides a quantitative value of endurance fitness for comparison of individual training effects and between people in endurance training. Maximal oxygen consumption reflects cardiorespiratory fitness and endurance capacity in exercise performance. VO2 max refers to the amount of oxygen a person uses during intense or maximal exercise. Its measurement gives the amount of oxygen consumed per minute for a kilogram of body weight in milliliters."},{"outcome_type":"primary","measure":"Maximum heart rate","time_frame":"One minutes","description":"It is determined by measuring the maximum number of heartbeats observed per minute reached during the KPET."},{"outcome_type":"primary","measure":"Maximum speed","time_frame":"One minutes","description":"It is determined by measuring the maximum average distance traveled per minute on the treadmill in meters / minute."}]}
{"nct_id":"NCT04618367","start_date":"2021-01-01","phase":"N/A","enrollment":30,"brief_title":"HAIC Combined With Lenvatinib and Sintilimab for Hepatocellular Carcinoma With PVTT","official_title":"HAIC Combined With Lenvatinib and Sintilimab for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus","primary_completion_date":"2021-12-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-12-30","last_update":"2020-12-22","description":"This study intends to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus lenvatinib and Sintilimab for patients hepatocellular carcinoma and portal vein tumor thrombus.","other_id":"GYEYJR-1","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  1. clinical diagnosis of HCC; 2. age between18 and 75 years; 3. refused to sorafenib\r\n             treatment; 4. type I PVTT, type II PVTT, or type III PVTT. 5. Child-Pugh class A or B;\r\n             6. Eastern Cooperative Group performance status (ECOG) score of 0-2; 7. Hemoglobin \r\n             8.5 g/dL Total bilirubin  30mmol/L Serum albumin  32 g/L ASL and AST  5 x upper\r\n             limit of normal Serum creatinine  1.5 x upper limit of normal INR  1.5 or PT/APTT\r\n             within normal limits Absolute neutrophil count (ANC) >1,500/mm3 8. Prothrombin time\r\n             18s or international normalized ratio < 1.7. 9. Ability to understand the protocol\r\n             and to agree to and sign a written informed consent document.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  1. Diffuse HCC; 2. Extrahepatic metastasis; 3. Obstructive PVTT involving both the\r\n             left and right portal vein or main portal vein.\r\n\r\n             4. Serious medical comorbidities. 5. Evidence of hepatic decompensation including\r\n             ascites, gastrointestinal bleeding or hepatic encephalopathy 6. Known history of HIV\r\n             7. History of organ allograft 8. Known or suspected allergy to the investigational\r\n             agents or any agent given in association with this trial.\r\n\r\n             9. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy 10. Evidence of\r\n             bleeding diathesis. 11. Patients with clinically significant gastrointestinal bleeding\r\n             within 30 days prior to study entry.\r\n      ","sponsor":"Sun Yat-sen University","sponsor_type":"Other","conditions":"Carcinoma, Hepatocellular|Liver Neoplasms|Sintilimab|Portal Vein Tumor Thrombus","interventions":[{"intervention_type":"Procedure","name":"Procedure: Hepatic arterial infusion chemotherapy","description":"administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 6 weeks"},{"intervention_type":"Drug","name":"Drug: Lenvatinib","description":"12 mg (or 8 mg) once daily (QD) oral dosing."},{"intervention_type":"Drug","name":"Drug: Sintilimab","description":"200mg intravenously every 3 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Progression free survival rate at 6 months","time_frame":"6 months","description":"Progression was defined as progressive disease by independent radiologic review according to mRECIST or death from any cause"},{"outcome_type":"secondary","measure":"Overall survival (OS)","time_frame":"6 months","description":"OS is the length of time from the date of randomization until death from any cause."},{"outcome_type":"secondary","measure":"Progression free survival (PFS)","time_frame":"6 months","description":"PFS is defined as the time from the date of randomization to the date of the first objectively documented tumor progression or death due to any cause."},{"outcome_type":"secondary","measure":"Objective response rate (ORR)","time_frame":"6 months","description":"ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all randomized subjects whose best overall response (BOR) is either a CR or PR."},{"outcome_type":"secondary","measure":"Adverse events","time_frame":"6 months","description":"Safety will be evaluated according to the NCI CTCAE Version 4.03. All observations pertinent to the safety of the study medication will be recorded on the CRF and included in the final report."}]}
{"nct_id":"NCT04730934","start_date":"2021-01-01","enrollment":1360,"brief_title":"Effects of the COVID-19 Pandemic on Fibromyalgia Patients","official_title":"Evaluation of the Physical and Emotional Effects of the COVID-19 Pandemic on Fibromyalgia Patients","primary_completion_date":"2021-02-25","study_type":"Observational [Patient Registry]","rec_status":"Completed","completion_date":"2021-02-25","last_update":"2021-03-01","description":"In this study, the effects of the symptoms related to the diseases of patients with fibromyalgia during the COVID-19 pandemic, their limitations in their social and business life, the need for different drugs, stress levels and the effect of the pandemic on the disease activity will be evaluated.","other_id":"2020/43-01","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":65,"population":"465 healthy participants, 465 patients with low back pain, 465 patients with fibromyalgia","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  patients aged between 18 and 65 years\r\n\r\n          -  patients who have low back pain lasting at least 3 months and started before pandemic\r\n\r\n          -  patients diagnosed with fibromyalgia for at least 6 months\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  patients diagnosed with major depression\r\n\r\n          -  patients who have a history of back surgery, fracture, infection, spinal stenosis\r\n\r\n          -  patients with malignancy\r\n      ","sponsor":"Kars State Hospital","sponsor_type":"Other","conditions":"Fibromyalgia|Chronic Low-back Pain","interventions":[{"intervention_type":"Other","name":"Other: Perceived stress scale","description":"Perceived stress scale (PSS) : The PSS is a validated 10-item self-report questionnaire which asks individuals to indicate how often they have found their lives unpredictable, uncontrollable, and overloaded in the last month. The higher scores indicating greater perceived stress."},{"intervention_type":"Other","name":"Other: Fibromyalgia impact questionnaire","description":"Fibromyalgia impact questionnaire (FIQ): The FIQ is composed of 10 items. The first item contains 11 questions related to physical functioning - each question is rated on a 4 point Likert type scale. Items 2 and 3 ask the patient to mark the number of days they felt well and the number of days they were unable to work (including housework) because of fibromyalgia symptoms. Items 4 through 10 are horizontal linear scales marked in 10 increments on which the patient rates work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety and depression."},{"intervention_type":"Other","name":"Other: The drugs used before and during the pandemic, the patient's job status, physical activity conditions, pain status","description":"Drug using: Antidepressant, SNRI, gabapentin, SSRI, myorelaxan, nsaid, paracetamol, pregabalin, tramadol, food supplement.\r\nJob status: Participants were questioned about their occupational status before and during the pandemic as \"I am a housewife\", \"I quit my job\", \"I worked from home\", \"I worked part-time\" and \"there was no change in my job\".\r\nPhysical activity: \"I do not have physical activity\", \"I do my daily work at home\", \"I do daily walks\", \"I exercise regularly\".\r\nPain status: Participants were questioned that their pain conditions before and during the pandemic were \"much worse\", \"worse\", \"a little bad\", \"no change\", \"a little good\", \" better\", It was questioned as \"much better\"."}],"outcomes":[{"outcome_type":"primary","measure":"Physical activity","time_frame":"4 weeks","description":"The physical activities of the participants were evaluated before and during the pandemic with the options \"I do not have physical activity\", \"I do my daily work at home\", \"I do daily walks\", \"I exercise regularly\"."},{"outcome_type":"primary","measure":"Occupation conditions","time_frame":"4 weeks","description":"Participants were questioned about their occupational status before and during the pandemic as \"I am a housewife\", \"I quit my job\", \"I worked from home\", \"I worked part-time\" and \"there was no change in my job\"."},{"outcome_type":"primary","measure":"General health condition","time_frame":"4 weeks","description":"Participants were questioned that their health conditions before and during the pandemic were \"much worse\", \"worse\", \"a little bad\", \"no change\", \"a little good\" \" better\", It was questioned as \"much better\"."},{"outcome_type":"primary","measure":"General pain condition","time_frame":"4 weeks","description":"Participants were questioned that their pain conditions before and during the pandemic were \"much worse\", \"worse\", \"a little bad\", \"no change\", \"a little good\", \" better\", It was questioned as \"much better\"."},{"outcome_type":"primary","measure":"Perceived stress scale","time_frame":"4 weeks","description":"Participants were questioned that their stress conditions before and during the pandemic"},{"outcome_type":"primary","measure":"Fibromyalgia impact questionnaire","time_frame":"4 weeks","description":"Fibromyalgia patients were questioned with fibromyalgia impact questionnaire before and during the pandemic"}]}
{"nct_id":"NCT04808063","start_date":"2021-01-01","phase":"N/A","enrollment":100,"brief_title":"Algorithm for Prophylactic Mesh Use in Emergency Laparotomy.","official_title":"Prevention of Incisional Hernia in Emergent Laparotomy Using a Prophylactic Mesh Augmentation Protocol Algorithm.","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-12-31","last_update":"2021-03-19","description":"Use of informed algorithm for patients selection of prophylactic mesh aplication after midline laparotomy in emergency surgery.","other_id":"CEIC2019/8240/I","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","intervention_model_description":"Patients with emergency surgery using midline laparotomy","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Emergency midline laparotomy.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Surgical infection present at the moment of surgery.\r\n\r\n          -  Ventrla or incisional hernia present at the moment of laparotomy .\r\n\r\n          -  Open abdomen.\r\n\r\n          -  Preoperative American Society of Anesthesiologist score (ASA) of V.\r\n      ","sponsor":"Hospital del Mar","sponsor_type":"Other","conditions":"Incisional Hernia of Midline of Abdomen","interventions":[{"intervention_type":"Procedure","name":"Procedure: Prophylactic mesh implantation","description":"Use of an algorithm for prophylactic mesh implantation in high risk patients after emergency midline laparotomy."}],"outcomes":[{"outcome_type":"primary","measure":"Incisional hernia","time_frame":"Durign first and second year of follow up","description":"Diagnosis by clinical or image control of incicionsal hernia during follow up."},{"outcome_type":"secondary","measure":"Incidence os surgical site ocurrence complications","time_frame":"During first postoperative month.","description":"Any surgical site ocurrence (SSO) complication will be registered and classified using Clavien-Dindo complication scale.\r\nMore common complications are:\r\nSeroma: a localized accumulation of serous fluid in a part of the body, occurring most commonly as a complication of a surgical procedure.\r\nWound haemathoma: wound related swelling of blood.\r\nSurgical site infection: infection that occurs after surgery in the part of the body where the surgery took place. Will be classified as superficial or deep infection.\r\nWound dehiscence: lack of cutaneous healing in surgical wound."},{"outcome_type":"secondary","measure":"Long term mesh related complications: chronic pain and mesh infection.","time_frame":"During first year of follow-up.","description":"Chronic pain: is any pain which persists beyond the normal healing period of 12 weeks. Visual analoge scale will be used to measure it.\r\nMesh infection: Late-onset mesh infection is defined as acute inflammatory response in surgical area within months or years after operation. It is diagnosed by the presence of infection symptoms and imaging examinations."},{"outcome_type":"other","measure":"Global rate of complication.","time_frame":"Durign first month of postoperative follow up.","description":"Any postoperative complication will be recorded and classified using Clavien-Dindo scale."},{"outcome_type":"other","measure":"Reintervention","time_frame":"During first postoperative month follow up.","description":"A second or subsequent intervention quotations due to postoperative comlications."},{"outcome_type":"other","measure":"Hospital readmission","time_frame":"During first postoperative month follow up.","description":"Patient admission to a hospital within 30 days after being discharged from an earlier hospital stay"}]}
{"nct_id":"NCT04578093","start_date":"2021-01-01","phase":"N/A","enrollment":300,"brief_title":"Implementation Strategy for a Peer-based Intervention to Prevent Teen Pregnancy","official_title":"Investigating an Implementation Strategy for a Peer-based Intervention to Prevent Teen Pregnancy","primary_completion_date":"2024-01-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2024-01-01","last_update":"2021-02-16","description":"Previously studied peer-based educational videos on LARC (long-acting reversible contraceptive) devices will be incorporated into a high school health curriculum. This will then be administered to the intervention high school. Outcomes including LARC knowledge, attitudes and uptake will be compared to a control high school.","other_id":"IRB 20-0250","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","intervention_model_description":"case-control","sampling_method":"","gender":"Female","minimum_age":13,"maximum_age":20,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        female, never used LARC, attending high school, less than 20 yo\r\n\r\n        Exclusion Criteria:\r\n\r\n        used LARC\r\n      ","sponsor":"The University of Texas Medical Branch, Galveston","sponsor_type":"Other","conditions":"Contraception Behavior","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: LARC peer-based curriculum","description":"Peer-based educational videos and supplemental activities"}],"outcomes":[{"outcome_type":"primary","measure":"Inquiries made of provider","time_frame":"6 months","description":"Incidence of teenagers initiating LARC discussion or asking provider questions about LARC when visiting the school-based healthcare clinic provider."},{"outcome_type":"secondary","measure":"LARC uptake","time_frame":"3 years","description":"Incidence of teenager using IUD or subnormal implant."}]}
{"nct_id":"NCT04810429","start_date":"2021-01-01","phase":"Phase 4","enrollment":30,"brief_title":"Comparison of Temporomandibular Joint Arthroscopy With Botulinum Toxin Injection Versus Placebo","official_title":"Comparison of Temporomandibular Joint Arthroscopy With Botulinum Toxin Injection Versus Placebo: a Randomized Clinical Trial","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-12-31","last_update":"2021-03-23","description":"There are several studies that have considered Botulinum toxin A (BoNT-A) injections are effective in treating symptoms for Temporomandibular Joint (TMJ) disorders. BoNT-A injections improve the hyper-tonicity of mandibular muscles and its consequent joint load reduction. Also injections of BoNT-A, for patients with articular disc displacement, resulted in pain relief and return of the normal movements of the mandible. The main goal of this study is to test the beneficial impact of BoNT-A injections in the masticatory muscles of patients submitted to TMJ surgical arthroscopy.","other_id":"Eudrac: 2020-005610-18","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","intervention_model_description":"For this randomized clinical trial an appropriate number of sealed envelopes will be prepared: 15 for placebo and 15 for the treated group. Patients with inclusion criteria will be seen in an orofacial pain session and assessed for pain using the VAS scale, by scoring the degree of pain between 0 (absence of pain) and 10 (maximum pain). Then the patients are proposed for TMJ arthroscopy. The nurse enters the room with the patient and asks to the patient to choose an envelope. In this moment, the envelope is placed on a table and the patient writes his name. The nurse accompanies the patient to the doctor's office. Alone, the nurse opens the envelope and sees the code and the indication of PLACEBO or BTXA. Then, she will prepare in her room, isolated from the whole team, 2 syringes. She will put the envelope in a bag and deliver a tray with 2 syringes for treatment and a code to identify the patient in the treatment room. The doctor injects the syringes according to the protocol.","sampling_method":"","gender":"All","minimum_age":12,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with TMJ with indication for arthroscopy\r\n\r\n          -  Age between 12-60 years old\r\n\r\n          -  Minimum level of pain for inclusion should be 5/10 (on a 0-10 VAS scale)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Previous treatment to TMD\r\n\r\n          -  Previous use of facial Botulinum Toxin\r\n\r\n          -  Any contraindication for the use of BTXA according to XEOMIN SmPC\r\n      ","sponsor":"Instituto Portugues da Face","sponsor_type":"Other","conditions":"Temporomandibular Joint Disorders","interventions":[{"intervention_type":"Drug","name":"Drug: Incobotulinumoxin A","description":"XEOMIN (incobotulinumtoxinA) is an approved medication that inhibits the release of acetylcholine and muscle blockage. Xeomin is indicated for the symptomatic treatment of blepharospasm and hemifacial spasm, cervical dystonia of a predominantly rotational type (spasmodic torticollis), spasticity of the upper limbs and chronic sialorrhea due to neurological changes. Xeomin comes as a white powder for solution for injection. When dissolved Xeomin is a clear, colorless solution that does not contain particles. Xeomin is reconstituted before use with sterile sodium chloride 9 mg / ml (0.9%) solution, without preservatives, for injections.\r\nThe active substance is Clostridium botulinum type A neurotoxin (150 kD), without complexing proteins. The other components are human albumin and sucrose."},{"intervention_type":"Procedure","name":"Procedure: TMJ surgical arthroscopy","description":"TMJ arthroscopy is a minimal invasive surgical technique for different types of temporomandibular joint (TMJ) internal derangements. Besides the acceptable outcomes of TMJ arthroscopy, the authors believe that adding to this treatment a single injection of BTXA into the temporalis and masseter muscles could reduce joint loading, improving TMJ arthroscopic results."}],"outcomes":[{"outcome_type":"primary","measure":"VAS score","time_frame":"5 weeks after injection and TMJ arthroscopy","description":"Improvement in TMJ pain: measured by the patient using a Visual Analogue scale (VAS), with a range from 0 to 10, with 0 being no pain and 10 having maximum unbearable pain. VAS score will be measured every week before surgery and in the fifth week after surgery."},{"outcome_type":"secondary","measure":"Palpable joint click","time_frame":"5 weeks after injection and TMJ arthroscopy","description":"Yes or No"},{"outcome_type":"secondary","measure":"Diet consistency tolerated","time_frame":"5 weeks after injection and TMJ arthroscopy","description":"regular diet, basic diet, liquid diet"},{"outcome_type":"secondary","measure":"Muscle Tenderness","time_frame":"5 weeks after injection and TMJ arthroscopy","description":"Masseter muscle, temporalis muscle, temporalis tendon, and lateral capsule of the TMJ) - Muscle sensitivity scale (0-3)"},{"outcome_type":"secondary","measure":"Maximum Mouth Opening","time_frame":"5 weeks after injection and TMJ arthroscopy","description":"in cm"},{"outcome_type":"secondary","measure":"GICS","time_frame":"5 weeks after injection and TMJ arthroscopy","description":"Global Impression of change by the subject"}]}
{"nct_id":"NCT04700631","start_date":"2021-01-01","phase":"N/A","enrollment":60,"brief_title":"Extracellular Vesicles as Biomarkers for Chronic Renal Failure","official_title":"Extracellular Vesicles as Biomarkers for Chronic Renal Failure","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-12-31","last_update":"2021-07-21","description":"The recent discovery of extracellular vesicles (EV) as a mechanism of intercellular communication has made it possible to develop a new field of health research and could bring new information on the pathological mechanisms of renal diseases. Definition of physiologic and pathologic values of urinary extracellular vesicles (EVu) between healthy subjects and chronic kidney diseases (CKD) patients could be a new tool for follow up of renal diseases. EV are found in all biological fluids including urine, that's why they are increasingly analyzed in renal pathologies. The main objective of this study is to determine the physiological values and the pathological thresholds of EVu.","other_id":"PI2020_843_0104","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  subject > 18 years old\r\n\r\n          -  healthy subjects : no medical history, in particular cardiovascular, without drug\r\n             treatment, without proteinuria, normal BMI\r\n\r\n          -  CRF patients : eGFR estimated according to the MRDR formula less than 89 mL/min/1,73m\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  patients under dialysis protocols\r\n\r\n          -  renal transplant patients\r\n      ","sponsor":"Centre Hospitalier Universitaire, Amiens","sponsor_type":"Other","conditions":"Chronic Renal Failure|Urinary Extracellular Vesicle","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: urinary extracellular vesicle concentration","description":"urinary extracellular vesicle concentration will be determined in urine samples from CRF and healthy patients"},{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: blood sample","description":"blood sample in order to determine creatin level"}],"outcomes":[{"outcome_type":"primary","measure":"variation of urinary extracellular vesicle concentration between both groups","time_frame":"one day","description":"variation of urinary extracellular vesicle concentration between both groups : healthy and CRF patients Urinary extracellular vesicle concentrations will be measured as number of extracellular vesicles per mL of urine"}]}
{"nct_id":"NCT03098225","start_date":"2021-01-01","phase":"Phase 4","enrollment":120,"brief_title":"A Trial to Evaluate the Efficacy of Orbital Radiotherapy in Graves' Orbitopathy","official_title":"A Phase IV, Randomized, Multi-center Clinical Trial to Compare the Efficacy of Orbital Radiotherapy in Association With Intravenous Glucocorticoids vs Intravenous Glucocorticoids Alone for Moderately Severe and Active Graves' Orbitopathy","primary_completion_date":"2024-03-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2024-03-31","last_update":"2020-03-25","description":"Graves' orbitopathy (GO) is a disfiguring and disabling disease that profoundly impairs the quality of life of affected patients. High dose intravenous (iv) glucocorticoids (GC) (ivGC) is a well established, widely used treatment for active GO. The use of systemic glucocorticoids takes advantage from their immune suppressive and antiinflammatory actions, resulting in an overall beneficial effect ranging from ~35 to ~60% of patients in various studies. The intravenous route of administration has been shown to be superior to the oral route, both in terms of GO outcome and side effect profile. The combination of ivGC and orbital radiotherapy (OR) is used routinely in patients with moderate-severe, active GO, as a second-line treatment, as also recommended in the recent Guidelines published by the European Thyroid Association/European Group on Graves' Orbitopathy. Thus, the majority of studies have shown that OR increases the response rate to GC. Those studies were performed using oral GC, whereas it is not known whether OR potentiate also the effects of ivGC. The present study is aimed at determining whether OR potentiate the effects of ivGC in the treatment of moderately severe and active GO, in terms of GO outcome and quality of life. A possible extension of the study can be foreseen, aimed at investigating the very long time GO outcome.","other_id":"ORGO","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":35,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. A diagnosis of Graves' disease based on the presence of hyperthyroidism (either\r\n             untreated or treated with antithyroid drugs) associated with detectable anti-TSH\r\n             receptor autoantibodies\r\n\r\n          2. No major treatments for hyperthyroidism (thyroidectomy or radioiodine) in the last 3\r\n             months\r\n\r\n          3. Euthyroidism on anti-thyroid medications or L'thyroxine (LT4) since at least 2 months\r\n\r\n          4. GO symptoms lasting since no more than one year\r\n\r\n          5. Active GO: CAS  3 out of 7 (worst eye)\r\n\r\n          6. Moderate or moderately severe GO: at least one of the following signs (worst eye):\r\n\r\n               -  Exophthalmos  22 mm\r\n\r\n               -  Eye muscle involvement with mono-ocular ductions in any direction of gaze of less\r\n                  than 30 or evident dismotility\r\n\r\n               -  Diplopia according to Gorman score of grades a-c\r\n\r\n          7. No corticosteroids or immunosuppressive treatment for GO in the last 3 months\r\n\r\n          8. No contraindication to OR: diabetes, hypertension, retinopathy of any type, glaucoma\r\n\r\n          9. Male and female patients of age: 35-75 years\r\n\r\n         10. Effective method of contraception during the whole trial and at least six weeks after\r\n             last intake of trial drugs (only female of reproducing age)\r\n\r\n         11. No mental illness that prevent patients from comprehensive, written informed consent\r\n\r\n         12. Compliant patient, regular follow-up possible\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Absence of Graves' hyperthyroidism (present or past)\r\n\r\n          2. Thyroidectomy or radioiodine in the last 3 months\r\n\r\n          3. Uncontrolled hyperthyroidism or hypothyroidism\r\n\r\n          4. GO symptoms lasting since more than one year\r\n\r\n          5. CAS <3 (worst eye)\r\n\r\n          6. Optic neuropathy\r\n\r\n          7. Contraindications to OR (diabetes, retinopathy of any kind)\r\n\r\n          8. Pregnancy, breast-feeding women\r\n\r\n          9. No informed consent\r\n\r\n         10. Acute or chronic liver disease\r\n\r\n         11. Relevant Malignancy\r\n\r\n         12. Chronic renal failure or other diseases of any relevance to prevent steroid treatment\r\n             13) Corticosteroids or other immunosuppressive agents within last 3 months\r\n\r\n         13. Recent (1 year) history of alcoholism or drug abuse\r\n\r\n         14. Previous orbital disease other than GO, eye injuries or surgery\r\n      ","sponsor":"University of Pisa","sponsor_type":"Other","conditions":"Thyroid Associated Ophthalmopathy","interventions":[{"intervention_type":"Radiation","name":"Radiation: Orbital radiotherapy","description":"A high-voltage linear accelerator will be used and a cumulative radiation dose of 20 Gy will be delivered to each eye in 10 fractionated doses over a period of 2 weeks. All patients will be treated in both eyes."},{"intervention_type":"Drug","name":"Drug: Methylprednisolone","description":"Methylprednisolone pulse therapy for 12 weeks as follows: 500 mg IV once weekly for 6 weeks, then 250 mg IV once weekly for a further 6 weeks. Cumulative dose 4.5 g."}],"outcomes":[{"outcome_type":"primary","measure":"Comparison of overall GO outcome determined using a composite evaluation","time_frame":"52 weeks","description":"A composite evaluation of GO was described previously.\r\nImprovement is defined as amelioration of two parameters in at least one eye, without deterioration of any parameters in both eyes:\r\nDeterioration is defined as worsening in two parameters in at least one eye:\r\nAll other cases are defined as \"no change\"\r\nThe parameters are:\r\nEyelid swelling (improvement/worsening according to EUGOGO Atlas evaluation)\r\nLid aperture in mm (significant variation: 2 or more mm)\r\nClinical activity score (CAS) (7 items: spontaneous pain, evoked pain, eyelid edema, eyelid redness, conjunctiva redness, caruncle edema, chemosis; significant change: at least 2 points)\r\nExophthalmos in mm (significant variation 2 or more mm)\r\nEye muscle involvement - diplopia score (Gorman score) (significant variation: disappearance or change in the degree, or improvement of ≥12 degrees in motility)"},{"outcome_type":"secondary","measure":"Comparison of overall GO outcome determined using a composite evaluation","time_frame":"26 weeks","description":"A composite evaluation of GO was described previously.\r\nImprovement is defined as amelioration of two parameters in at least one eye, without deterioration of any parameters in both eyes:\r\nDeterioration is defined as worsening in two parameters in at least one eye:\r\nAll other cases are defined as \"no change\"\r\nThe parameters are:\r\nEyelid swelling (improvement/worsening according to EUGOGO Atlas evaluation)\r\nLid aperture in mm (significant variation: 2 or more mm)\r\nClinical activity score (CAS) (7 items: spontaneous pain, evoked pain, eyelid edema, eyelid redness, conjunctiva redness, caruncle edema, chemosis; significant change: at least 2 points)\r\nExophthalmos in mm (significant variation 2 or more mm)\r\nEye muscle involvement - diplopia score (Gorman score) (significant variation: disappearance or change in the degree, or improvement of ≥12 degrees in motility)"},{"outcome_type":"secondary","measure":"Comparison of a disease specific quality of life questionnaire (GO-QoL)","time_frame":"26 weeks","description":"Comparison of a disease specific quality of life questionnaire (GO-QoL)"},{"outcome_type":"secondary","measure":"GO relapse","time_frame":"52 weeks","description":"GO worsening in comparison with the 26 week evaluation, by a composite GO score:\r\nWorsening is defined as worsening in two parameters in at least one eye:\r\nThe parameters are:\r\nEyelid swelling (worsening according to EUGOGO Atlas evaluation)\r\nLid aperture in mm (significant worsening: 2 or more mm)\r\nClinical activity score (CAS) (7 items: spontaneous pain, evoked pain, eyelid edema, eyelid redness, conjunctiva redness, caruncle edema, chemosis; significant worsening: at least 2 points)\r\nExophthalmos in mm (significant worsening: 2 or more mm)\r\nEye muscle involvement - diplopia score (Gorman score) (significant worsening: appearance or change in the degree, or worsening of ≥12 degrees in motility)"},{"outcome_type":"secondary","measure":"Comparison of a disease specific quality of life questionnaire (GO-QoL)","time_frame":"52 weeks","description":"Comparison of a disease specific quality of life questionnaire (GO-QoL)"}]}
{"nct_id":"NCT04173975","start_date":"2021-01-01","phase":"N/A","enrollment":15,"brief_title":"Validation of the Efficacy and Usability of the BELK Orthosis Knee Module in a Neurological Setting (BELK@CCP)","official_title":"Validation of the Efficacy and Usability of the BELK Orthosis Knee Module in a Neurological Setting","primary_completion_date":"2021-03-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2021-08-31","last_update":"2020-10-08","description":"This present study will be devoted to the first clinical study on the efficacy of the BELK system in enhancing mobility and improve the knee rehabilitation process in people with NeuroMuscular Diseases (NMD) and Central Nervous System (CNS) disorders with knee instability that implies deficit in gait and in locomotion during ADL. Participants will receive a 6-week training program (3 weeks with the BELK orthosis knee module) in a clinical setting in add-on to the standard neuro-rehabilitation treatment. Gait analysis and Instrumental Test will be performed every week till the end of the six-week training period while the Clinical Scales and Questionnaires will be performed after three weeks and at the end of the training period. Finally, additional outcome measures comprise the scores on the System Usability Scale (SUS) to evaluate the hardware and the Software Usability Measurement Inventory (SUMI) to evaluate the software of the BELK orthosis. These two measures will be administrated at the end of training with Belk orthosis, to rate patients' and operators' (e.g., physical therapist, medical doctors) satisfaction. During 2018, the company GOGOA (www.gogoa.eu), specialized in design, manufacturing and commercialization of Robotic Assisted Rehabilitation (RAR) systems, has developed a first prototype of the BELK system, a powered wearable robotic device that can be used for knee rehabilitation, in the sub-acute phase of knee injuries. As BELK is a wearable device, it can be used both, by the physiotherapist in the rehabilitation centers, improving the knee rehabilitation process and increasing patients' comfort, and accelerating their rehabilitation process. Casa di Cura del Policlinico (CCP https://www.ccppdezza.it/en/) is a fully integrated multi-specialty clinical center aiming at providing both inpatient and outpatient services mainly directed to neurological patients. The Center is constituted as a Department of Neuro-rehabilitation Sciences, accredited by the Italian National Health System, and economically supported by Regione Lombardia. CCP offers to chronic neurological patients the highest comprehensive standards of care in a comfortable environment, through a multidisciplinary patient management approach organized around a core rehabilitation program.","other_id":"BELK@CCP","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Single","intervention_model_description":"Participants will receive a 6-week training program in a clinical setting in add-on to the standard neuro-rehabilitation treatment.\r\nThe add-on rehabilitation training will be focused on lower limb with specific activities for knee instability, and will comprise 3 weeks using the BELK orthosis knee module and 3 weeks without any orthosis.","sampling_method":"","gender":"All","minimum_age":30,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age: 30 - 85\r\n\r\n          -  Sex: males and females\r\n\r\n          -  Diagnosis of Neuromuscular diseases (NMD) or central nervous system (CNS) disorder\r\n             with knee instability conditioning gait\r\n\r\n          -  Functional Ambulation Categories (FAC) > 3\r\n\r\n          -  Mini Mental State Examination (MMSE) > 24\r\n\r\n          -  Ability to walk at least 10 meters alone or with maximum 1 person assistance\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Bilateral impairment of the knees\r\n\r\n          -  Knee implant\r\n\r\n          -  Lower extremity amputation\r\n\r\n          -  Severe sensorial impairment of the lower limbs\r\n\r\n          -  Legal blindness or severe visual impairment\r\n\r\n          -  Pacemakers or metal implants\r\n\r\n          -  Refusal to give informed consent\r\n      ","sponsor":"Casa di Cura Privata del Policlinico SpA","sponsor_type":"Other","conditions":"Knee Instability|Neuromuscular Diseases|Central Nervous System Diseases|Stroke","interventions":[{"intervention_type":"Device","name":"Device: With knee exoskeleton","description":"BELK is a wearable system that assists when and where the patient needs it intelligently through proper control of the system and optimized gait assistance techniques. Assisted-as-needed control allows to create a force field along a desired trajectory, proportionally applying torque only when patient deviates from the pre-programmed correct pattern. This force field control, by assisting only the segments that the patient need, produces a natural gait pattern, improving the rehabilitation process."}],"outcomes":[{"outcome_type":"primary","measure":"Change in walking velocity","time_frame":"Before and Immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)","description":"Walking velocity [m/s] will be calculated during walk test (10MWT). Markers positioned on the body will be tracked through a motion capture software and analyzed."},{"outcome_type":"primary","measure":"Change in Gait Profile Score","time_frame":"Before and Immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)","description":"Gait Profile Score (GPS) is a useful index to analyze the gait performances. It is calculated starting from fifteen Gait Variable Score (GVS) which give a deeper view on the variables related to the locomotion trials."},{"outcome_type":"secondary","measure":"Change in 6-minute walking test (6MWT)","time_frame":"Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)","description":"The six-minute walk test (6MWT) measures the distance, in meters, that an individual is able to walk over a total of six minutes on a hard, flat surface."},{"outcome_type":"secondary","measure":"Change in joint force","time_frame":"Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)","description":"Joint forces will be calculated as the amount of pressure recorded in newtons on the force plates during walking tests."},{"outcome_type":"secondary","measure":"Change in Surface electromyography (sEMG)","time_frame":"Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)","description":"Surface electromyography (sEMG) is a non-invasive procedure involving the detection, recording and interpretation of the electric activity of groups of muscles at rest (i.e., static) and during activity (i.e., dynamic). The procedure is performed using a single or an array of electrodes placed on the skin surface over the muscles to be tested. Recording can also be made using a hand-held device, which is applied to the skin surface at different sites. Electrical activity is assessed by computer analysis of the frequency spectrum, amplitude, or root-mean-square of the electrical action potential."},{"outcome_type":"secondary","measure":"Change in energy cost of walking","time_frame":"Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)","description":"Energy cost of walking, expressed in ml O2/kg/m will be measured using indirect calorimetry device"},{"outcome_type":"secondary","measure":"Change in Stair Climb Test (SCT)","time_frame":"Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)","description":"The Stair Climb Test (SCT) measures, in seconds, the time taken by an individual to ascend and descend 10 steps (each step is 0.18 m in height)."},{"outcome_type":"secondary","measure":"Change in Timed Up and Go test (TUG)","time_frame":"Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)","description":"The Timed \"Up and Go\" Test measures, in seconds, the time taken by an individual to stand up from a standard arm chair (approximate seat height of 46 cm, arm height 65 cm), walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair, and sit down."},{"outcome_type":"secondary","measure":"Change in Short Form Survey Instrument (SF36)","time_frame":"Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)","description":"Confidence levels will be calculated using the Short Form Survey Instrument (SF36). Items are scored using Likert scale and yes/no options. Scales are standardized with a scoring algorithm to obtain a score ranging from 0-100. High scores indicate better health status."},{"outcome_type":"secondary","measure":"Change in International Knee Documentation Committee (IKDC) Questionnaire","time_frame":"Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)","description":"The IKDC Questionnaire is a subjective scale that provides patients with an overall function score. The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. Symptoms sub scale helps to evaluate things such as pain, stiffness, swelling and giving-way of the knee. Meanwhile, the sports activity sub scale focuses on functions like going up and down the stairs, rising from a chair, squatting and jumping. The knee function sub scale asks patients one simple question: how is their knee at present versus how was their knee prior to injury?\r\nScores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function."},{"outcome_type":"secondary","measure":"Change in Knee Outcome Survey (KOS)","time_frame":"Before and immediately after the rehabilitation training of each arm (Initial, after 3 weeks and final)","description":"The Knee Outcome Survey (KOS) is a patient-completed questionnaire that provides a percentage of disability during every day activities (activities of daily living sub scale) or sports (sports activity sub scale). The lower the percentage, the higher the disability.\r\nThis is a self-report measure that is broken down into two categories (ADLs and sport activities) that rates perceived disability with 5 being \"no difficulty\" and 0 being \"unable to perform\".[1]"},{"outcome_type":"secondary","measure":"System Usability Scale (SUS)","time_frame":"Immediately after the rehabilitation training of experimental arm.","description":"The scores on the System Usability Scale (SUS) was measured in order to assess the usability of BELK during rehabilitation training"}]}
{"nct_id":"NCT03296098","start_date":"2020-12-31","phase":"Phase 2","enrollment":300,"brief_title":"Study of the Safety and Efficacy of Ulipristal Acetate (UPA) Used Daily as a Contraceptive","official_title":"A Multi-center, Open-label, Non-comparative Study of the Safety and Contraceptive Efficacy of Continuous Daily Oral 10 mg of Ulipristal Acetate (UPA)","primary_completion_date":"2022-01-31","study_type":"Interventional","rec_status":"Suspended","completion_date":"2022-12-31","last_update":"2019-10-09","description":"This is a Phase IIb multicenter, open-label, non-comparative trial of continuous daily oral 10 mg of ulipristal acetate (UPA) to evaluate its contraceptive efficacy as the primary method of contraception.","other_id":"CCN013B","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":35,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        To enroll into the clinical trial, potential subjects must:\r\n\r\n          1. Be in good general overall health with no chronic medical conditions that result in\r\n             periodic exacerbations that require significant medical care.\r\n\r\n          2. Be women between 18 and 35 years inclusive at the enrollment visit.\r\n\r\n          3. Have regular menstrual cycles that occur every 21-35 days when not using hormonal\r\n             contraception.\r\n\r\n             a. If subject is postpartum or post-abortal, she must have one menstrual bleed prior\r\n             to enrollment.\r\n\r\n          4. Be seeking contraception, and willing to use the study drug as the only contraception\r\n             method during their months of study participation.\r\n\r\n          5. If using a ring, patch, pill, or implant prior to study treatment, the subject must\r\n             discontinue the active hormone at least 4 days, and no more than 7 days, prior to\r\n             study drug initiation. Note that for combined oral contraceptive users, placebo pills\r\n             are not counted as active hormone.\r\n\r\n          6. If using a hormonal intrauterine device (IUD) prior to study treatment, the IUD must\r\n             be removed prior to study drug initiation; removal and study drug initiation can occur\r\n             on the same day, but the subject must refrain from sexual intercourse for 7 days\r\n             following IUD removal.\r\n\r\n          7. If using a copper IUD prior to study treatment, the IUD must be removed prior to study\r\n             drug initiation; removal and study drug initiation can occur on the same day. The IUD\r\n             removal and study drug initiation must occur during the first 7 days of a spontaneous\r\n             menses.\r\n\r\n          8. If using a non-hormonal contraceptive method (e.g. condoms or withdrawal) prior to\r\n             study treatment, drug initiation should occur within the first 7 days of a spontaneous\r\n             menses.\r\n\r\n          9. If the woman has received a long-acting injectable contraceptive (e.g.\r\n             depomedroxyprogesterone acetate) during the 10 months prior to screening, she must\r\n             have resumed cyclic spontaneous menses (two menstrual bleeds) since last injection.\r\n\r\n         10. Have a negative urine pregnancy test at the enrollment visit.\r\n\r\n         11. Have an intact uterus and both ovaries.\r\n\r\n         12. In the opinion of the investigator, be willing and able to follow all study\r\n             requirements, including use of the study product and be willing to record requested\r\n             information on a daily diary.\r\n\r\n         13. Understand and sign an (Institutional Review Board) IRB approved informed consent form\r\n             prior to screening activities (including fasting blood draws).\r\n\r\n         14. Have a diastolic blood pressure (BP) 95 mm Hg and systolic BP 145 mm Hg after 5\r\n             minutes in a sitting position at the enrollment visit. Hypertensive subjects who are\r\n             treatment controlled and, in the judgment of the investigator, are good candidates\r\n             require a waiver for participation.\r\n\r\n         15. Have a body mass index (BMI) < 40 kg/m2.\r\n\r\n         16. Be planning to have at least one act of heterosexual vaginal intercourse each month\r\n             during study participation.\r\n\r\n         17. Be willing to accept an unknown risk of pregnancy during study participation.\r\n\r\n        Exclusion Criteria:\r\n\r\n        To enroll into the clinical trial, potential subjects must not:\r\n\r\n          1. Be women with irregular menstrual cycles defined as a variation in cycle length of\r\n             more than 5 days.\r\n\r\n          2. Be planning pregnancy within their months of study participation.\r\n\r\n          3. Be currently breast-feeding or within 30 days of discontinuing breast feeding, unless\r\n             the subject has already had a menses following discontinuation of breast feeding.\r\n\r\n          4. Have undiagnosed abnormal genital bleeding.\r\n\r\n          5. Have known hypersensitivity to the active substance UPA or any of the excipients of\r\n             the study treatment.\r\n\r\n          6. Have a history of endometrial hyperplasia or malignancy.\r\n\r\n          7. Have abnormal Transvaginal Ultrasound (TVUS) or safety labs done at the screening\r\n             visit recognized as clinically significant by the investigator (or medically qualified\r\n             designee).\r\n\r\n          8. Have a previous history of endometrial ablation.\r\n\r\n          9. Have a previous history of liver disease or screening liver enzyme results more than\r\n             three times the upper limit of normal values.\r\n\r\n         10. Have a known clinically significant Pap test abnormality, as managed by current local\r\n             or national guidelines, that would require treatment during study participation.\r\n\r\n         11. Have any of the following known contraindication to progestin-only oral contraceptive\r\n             (OC):\r\n\r\n               1. History or existing breast cancer, or other hormone sensitive neoplasia;\r\n\r\n               2. Current or history of ischemic heart disease or stroke while pregnant or taking\r\n                  birth control pills;\r\n\r\n               3. Systemic Lupus Erythematosus with positive or unknown antiphospholipid\r\n                  antibodies;\r\n\r\n               4. Benign or malignant liver tumors;\r\n\r\n               5. Severe (decompensated) cirrhosis.\r\n\r\n         12. Have known or suspected alcoholism or drug abuse.\r\n\r\n         13. Have known HIV infection.\r\n\r\n         14. Have an anticipated need for regular condom use as defined as use of at least one\r\n             condom per month after enrollment.\r\n\r\n         15. Have previously participated in the study.\r\n\r\n         16. Have a current need for exogenous hormones or therapeutic anticoagulants.\r\n\r\n         17. Have a current or history of deep vein thromboembolic disorder or aortic\r\n             thromboembolism, including stroke and myocardial infarction\r\n\r\n         18. Have a current or past medically diagnosed severe depression, which, in the opinion of\r\n             the investigator, could be exacerbated by use of a hormonal contraceptive, unless she\r\n             is stable on antidepressant medication.\r\n\r\n         19. Have concomitant use of medication thought to interact with UPA (per Summary of\r\n             Product Characteristics (SPCs)) such as CYP3A4 inducers (rifampin, barbiturates,\r\n             carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, phenytoin, St John's\r\n             Wort, topiramate).\r\n\r\n         20. Have concomitant use of moderate or strong CYP3A4 inhibitors as identified by the FDA.\r\n             Subjects who begin use of a moderate CYP3A4 inhibitor after study enrollment require a\r\n             waiver to continue in the study.\r\n\r\n         21. Use any medications that can interfere with the metabolism of hormonal contraceptives,\r\n             antibiotics that can interfere with metabolism of hormonal contraceptives, or any\r\n             drugs designated by the FDA as falling in the Pregnancy and Lactation narrative\r\n             subsections (formerly Category D or X medications).\r\n\r\n         22. Currently participate in any other trial of an investigational medicine or device or\r\n             have participated in the three months before start of treatment or be planning to\r\n             participate in another clinical trial during this study.\r\n\r\n         23. Have a history of a bariatric surgery procedure associated with malabsorption.\r\n\r\n         24. Be planning to undergo major surgery during study participation.\r\n\r\n         25. Live outside of the catchment area of the study site.\r\n\r\n         26. Have used UPA, including Ella, within 30 days prior to enrollment and not had a menses\r\n             since using UPA.\r\n\r\n         27. Any site staff member with delegated study responsibilities or a family member of a\r\n             site staff member with delegated study responsibilities.\r\n      ","sponsor":"Health Decisions","sponsor_type":"Other","conditions":"Contraception|Healthy Female","interventions":[{"intervention_type":"Drug","name":"Drug: Ulipristal acetate","description":"Ulipristal aceteate 5 mg oral tablets to take two tablets daily."}],"outcomes":[{"outcome_type":"secondary","measure":"Changes from baseline in creatinine levels (safety and tolerability).","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Changes from baseline in calcium levels (safety and tolerability).","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Changes from baseline in fasting glucose levels (safety and tolerability).","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Changes from baseline in blood urea nitrogen levels (safety and tolerability).","time_frame":"6 months"},{"outcome_type":"primary","measure":"Evaluate the contraceptive efficacy at 6 months based on the calculated Pearl Index for the evaluable for pregnancy population.","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Incidence of treatment emergent adverse events (safety and tolerability) during 6 month use of UPA.","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Changes from baseline in sodium levels (safety and tolerability).","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Changes from baseline in potassium levels (safety and tolerability).","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Changes from baseline in chloride levels (safety and tolerability).","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Changes from baseline in bicarbonate levels (safety and tolerability).","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Changes from baseline in total bilirubin levels (safety and tolerability).","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Changes from baseline in total alkaline phosphatase levels (safety and tolerability).","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Changes from baseline in total alanine aminotransferase levels (safety and tolerability).","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Changes from baseline in total aspartate transaminase levels (safety and tolerability).","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Changes from baseline in total albumin levels (safety and tolerability).","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Changes from baseline in total cholesterol levels (safety and tolerability).","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Changes from baseline in HDL cholesterol levels (safety and tolerability).","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Changes from baseline in LDL cholesterol levels (safety and tolerability).","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Changes from baseline in triglycerides levels (safety and tolerability).","time_frame":"10 months"},{"outcome_type":"secondary","measure":"Changes from baseline in acceptability of UPA using an Acceptability Questionnaire (acceptability).","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Changes from baseline in bleeding pattern using a subject diary (tolerability).","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Changes from baseline in endometrial thickness using transvaginal ultrasound.","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Changes from baseline in endometrium using endometrial biopsy results.","time_frame":"6 months"}]}
{"nct_id":"NCT02811809","start_date":"2020-12-31","phase":"Phase 2","enrollment":0,"brief_title":"Apalutamide Plus Intermittent Hormone Therapy Versus Intermittent Hormone Therapy Alone in Prostate Cancer","official_title":"Apalutamide Plus Intermittent Hormone Therapy (IHT) Versus IHT Alone in Prostate Cancer Patients With Biochemical Recurrence","primary_completion_date":"2024-12-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2025-12-31","last_update":"2020-02-27","description":"This study is open to men who have biochemical recurrence (BCR, increased PSA) following local treatment of their prostate cancer. Androgen deprivation therapy (ADT) is a standard treatment option, but is only effective for 16-24 months and has a number of side effects that impact quality of life. These side effects may include fatigue, hot flushing, loss of sex drive, brain fog, decreased bone mineral density, loss of muscle mass, mild anemia (low levels of red blood cells that can make people feel tired and weak), diabetes (low blood sugar), heart disease, metabolic syndromes (sometimes called \"pre-diabetes\" and includes obesity, increased blood pressure, high levels of cholesterol and triglycerides in blood), and risk of fractures. An alternative to continuous ADT is intermittent administration, where patients are given \"breaks\" from ADT to let their testosterone levels return to baseline. There are a number of potential benefits to intermittent hormone therapy (IHT): (1) longer time to the development of resistance; (2) improved patient quality of life owing to recovery from adverse effects, particularly sexual function; and (3) substantial cost savings owing to less time spent receiving medication. Leuprolide is the name of the ADT / IHT drug. Apalutamide is an investigational drug, which means it has not been approved by the Food and Drug Administration (FDA). It is an antitumor drug, taken by mouth. The purpose of this study is to determine the ability of Apalutamide to extend the time between the first two injections of leuprolide and improve quality of life. This study will also look at the safety of Apalutamide and the effects that Apalutamide has on prostate cancer. Men will be randomized (like flipping a coin) to receive: - Group A: Leuprolide + Apalutamide or - Group B: Leuprolide only (until second leuprolide injection), then leuprolide + Apalutamide 45 men will be in Group A and 21 men will be in Group B. Leuprolide is given as an intramuscular shot that lasts for 3 months intermittently and Apalutamide is taken by mouth (4 tablets) daily. Each cycle is 4 weeks long. Intermittent treatment with Apalutamide + leuprolide will continue until continuous leuprolide is needed to maintain undetectable PSA levels (i.e., PSA levels rise above undetectable level unless leuprolide is given without pause, every 3 months).","other_id":"GU-15-105","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age  18 years\r\n\r\n          -  Patients with a diagnosis of adenocarcinoma of the prostate\r\n\r\n          -  Patients with BCR (PSA becomes detectable, with absolute value 1) following\r\n             prostatectomy who have no evidence of metastatic disease based on radiographic\r\n             assessment.\r\n\r\n          -  Patients with BCR following radiation therapy who have no radiographic involvement per\r\n             mpMRI and CT (RTOG-ASTRO Phoenix criteria), size of pelvic nodes 1 cm, and whose\r\n             MRI-directed prostate biopsies are negative.\r\n\r\n          -  Patients must be free of serious comorbidity as determined by investigator.\r\n\r\n          -  Clinical laboratory values at screening:\r\n\r\n          -  Serum testosterone level 150 ng/dL\r\n\r\n          -  Hemoglobin 9.0 g/dL, independent of transfusion and/or growth factors within 3 months\r\n             prior to randomization\r\n\r\n          -  Platelet count 100,000 /L independent of transfusion and/or growth factors within 3\r\n             months prior to randomization\r\n\r\n          -  Serum albumin 3.0 g/dL\r\n\r\n          -  GFR >45 mL/min\r\n\r\n          -  Serum potassium 3.5 mmol/L\r\n\r\n          -  Serum total bilirubin 1.5  ULN (Note: In subjects with Gilbert's syndrome, if total\r\n             bilirubin is >1.5  ULN, measure direct and indirect bilirubin and if direct bilirubin\r\n             is 1.5  ULN, subject may be eligible)\r\n\r\n          -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <2.5  ULN\r\n\r\n          -  Medications known to lower the seizure threshold (see list under prohibited meds,\r\n             Appendix 3) must be discontinued or substituted at least 4 weeks prior to study entry.\r\n\r\n          -  Agrees to use a condom (even men with vasectomies) and another effective method of\r\n             birth control if he is having sex with a woman of childbearing potential or agrees to\r\n             use a condom if he is having sex with a woman who is pregnant while on study drug and\r\n             for 3 months following the last dose of study drug. Must also agree not to donate\r\n             sperm during the study and for 3 months after receiving the last dose of study drug.\r\n\r\n          -  Written, informed consent to participate in this study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  PSA doubling time >12 months\r\n\r\n          -  Positive for HIV or chronic hepatitis B or hepatitis C infection\r\n\r\n          -  Another primary malignancy that has not been in remission for at least 2 years.\r\n             Non-melanoma skin cancer allowed.\r\n\r\n          -  Use of herbal products that may decrease PSA levels (e.g., saw palmetto) or systemic\r\n             corticosteroids greater than the equivalent of 10 mg of prednisone per day within 4\r\n             weeks of screening laboratory studies.\r\n\r\n          -  Any other condition, including concurrent medical condition, social circumstance or\r\n             drug dependency, which in the opinion of the investigator could compromise patient\r\n             safety and/or compliance with study requirements\r\n\r\n          -  History of any of the following:\r\n\r\n               -  Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke\r\n                  within 1year to randomization, brain arteriovenous malformation, Schwannoma,\r\n                  meningioma, or other benign CNS or meningeal disease which may require treatment\r\n                  with surgery or radiation therapy)\r\n\r\n               -  Severe or unstable angina, myocardial infarction, symptomatic congestive heart\r\n                  failure, arterial or venous thromboembolic events (eg, pulmonary embolism,\r\n                  cerebrovascular accident including transient ischemic attacks), or clinically\r\n                  significant ventricular arrhythmias within 6 months prior to randomization Any\r\n                  condition that in the opinion of the investigator, would preclude participation\r\n                  in this study\r\n\r\n          -  Current evidence of any of the following:\r\n\r\n               -  Uncontrolled hypertension\r\n\r\n               -  Gastrointestinal disorder affecting absorption\r\n\r\n               -  Active infection (eg, human immunodeficiency virus [HIV] or viral hepatitis) Any\r\n                  condition that in the opinion of the investigator, would preclude participation\r\n                  in this study\r\n      ","sponsor":"The University of Texas Health Science Center, Houston","sponsor_type":"Other","conditions":"Prostate Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Apalutamide","description":"Apalutamide 240 mg (4 60mg tablets) daily"},{"intervention_type":"Drug","name":"Drug: IHT","description":"Leuprolide 3-month depot 22.5 intramuscular dose"}],"outcomes":[{"outcome_type":"secondary","measure":"Time to testosterone recovery to >50 ng/dl","time_frame":"48 months","description":"Time to testosterone recovery to >50 ng/dl"},{"outcome_type":"secondary","measure":"Duration of testosterone recovery","time_frame":"48 months","description":"Duration of testosterone recovery"},{"outcome_type":"secondary","measure":"Circulating tumor cell (CTC) enumeration","time_frame":"48 months","description":"Circulating tumor cell (CTC) enumeration"},{"outcome_type":"secondary","measure":"Time until BCR after discontinuation of Apalutamide and ADT","time_frame":"48 months","description":"Time until BCR after discontinuation of Apalutamide and ADT"},{"outcome_type":"secondary","measure":"Quality of life as determined by FACT-P survey","time_frame":"48 months","description":"Quality of life as determined by FACT-P survey"},{"outcome_type":"secondary","measure":"Number of Adverse Events","time_frame":"48 months","description":"Number of Adverse Events"},{"outcome_type":"primary","measure":"Time to second injection","time_frame":"48 months","description":"Time to second injection"},{"outcome_type":"secondary","measure":"Time to prostate-specific antigen (PSA) nadir","time_frame":"48 months","description":"Time to prostate-specific antigen (PSA) nadir"},{"outcome_type":"secondary","measure":"Duration of PSA nadir","time_frame":"48 months","description":"Duration of PSA nadir"}]}
{"nct_id":"NCT04648345","start_date":"2020-12-31","phase":"N/A","enrollment":90,"brief_title":"Efficacy and Safety of Erector Spinal Plane Block (ESPB) for Analgesia in Laparoscopic Cholecystectomy","official_title":"Efficacy and Safety of Erector Spinal Plane Block (ESPB) for Intraoperative and Postoperative Analgesia in Laparoscopic Cholecystectomy : A Randomized, Single-blindControlled Clinical Trial.","primary_completion_date":"2021-03-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2021-05-31","last_update":"2020-12-01","description":"Purpose: to evaluate the efficacy and safety of erector spinal block (ESB) for analgesia in laparoscopic cholecystectomyLC. Method: This study is a randomized, single-blind, controlled clinical trial. Pre-operative ultrasound-guided bilateral erector spinae plane block will be performed in the ESPB group. Vertebral side block will be performed in the VSB group. And the control group will receive local anaesthesia after the surgery. Intraoperative and postoperative analgesia effect and side effects will be compared between the three groups.","other_id":"20004-0-01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","intervention_model_description":"A randomized, single-blinded, controlled clinical trial","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  American Society of Anesthesiologists (ASA) physical status 1-3\r\n\r\n          -  Scheduled for elective laparoscopic cholecystectomy surgery under general anesthesia\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  patient refusal\r\n\r\n          -  pregnancy\r\n\r\n          -  history of allergy to study drugs\r\n\r\n          -  neurological and cognitive disorders\r\n\r\n          -  coagulopathy\r\n\r\n          -  chronic pain disorders\r\n\r\n          -  infections at the injection site\r\n\r\n          -  history of abdominal surgery\r\n      ","sponsor":"Beijing Tsinghua Chang Gung Hospital","sponsor_type":"Other","conditions":"Analgesia","interventions":[{"intervention_type":"Procedure","name":"Procedure: Erector spinal plane block","description":"After induction of general anesthesia, pre-operative ultrasound-guided bilateral erector spinae plane block/ vertebral side block will be performed in the ESPB/VSB group. Local block will be performed at the surgical incisions after the surgery under general anesthesia. All the intervention will be performed without patients' awareness."}],"outcomes":[{"outcome_type":"primary","measure":"Pain intensity at rest(Hour 2)","time_frame":"Hour 2","description":"Using the Numeric Rating Scale (NRS) to evaluate the pain intensity at rest two hours after the surgery."},{"outcome_type":"primary","measure":"Pain intensity at rest (Hour 6)","time_frame":"Hour 6","description":"Using the Numeric Rating Scale (NRS) to evaluate the pain intensity at rest six hours after the surgery."},{"outcome_type":"primary","measure":"Pain intensity at rest (Hour 24)","time_frame":"Hour 24","description":"Using the Numeric Rating Scale (NRS) to evaluate the pain intensity at rest 24 hours after the surgery."},{"outcome_type":"secondary","measure":"The overall dose of remifentanil","time_frame":"During the surgery","description":"The overall dose of remifentanil used in the surgery."}]}
{"nct_id":"NCT04483687","start_date":"2020-12-31","phase":"Phase 3","enrollment":0,"brief_title":"Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Ankylosing Spondylitis Who Have an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drug Therapy","official_title":"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects With Active Ankylosing Spondylitis Who Have an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drug Therapy","primary_completion_date":"2023-01-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2024-09-30","last_update":"2021-01-11","description":"The primary objective of this study is to evaluate the effect of filgotinib versus placebo on signs and symptoms of active ankylosing spondylitis (AS), evaluated by Assessment of SpondyloArthritis international Society 40% improvement (ASAS40) response at Week 16 in participants with active AS who have an inadequate response to biologic disease-modifying antirheumatic drug therapy.","other_id":"GS-US-433-5305","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Key Inclusion Criteria:\r\n\r\n          -  Ambulatory male or female individuals who are  18 years of age ( 20 years of age in\r\n             Japan) on the day of signing informed consent\r\n\r\n          -  Have had inadequate response or intolerance to at least 1 and not more than 3 biologic\r\n             disease-modifying antirheumatic drugs (bioDMARDs) administered for the treatment of\r\n             ankylosing spondylitis (AS) or inflammatory arthritis\r\n\r\n          -  Have an established diagnosis of radiographic axial spondyloarthritis (SpA)/ AS by a\r\n             rheumatologist (or other specialist with expertise in diagnosing AS)\r\n\r\n          -  Meet Assessment of SpondyloArthritis international Society (ASAS) classification\r\n             criteria for axial SpA with radiographic sacroiliitis on imaging at screening as\r\n             follows:\r\n\r\n               -  History of back pain  3 months and age at onset of back pain < 45 years, AND\r\n\r\n               -  Radiographic sacroiliitis Grade  2 bilaterally or Grade 3-4 unilaterally, AND\r\n\r\n               -   1 SpA feature (refer to protocol; inflammatory back pain, arthritis, heel\r\n                  enthesitis, uveitis anterior, dactylitis, psoriasis, inflammatory bowel disease\r\n                  (IBD), good response to nonsteroidal anti-inflammatory drugs (NSAIDs), family\r\n                  history of SpA, historically positive human leukocyte antigen B27 (HLA-B27),\r\n                  elevated C-reactive protein (CRP))\r\n\r\n          -  Have active AS at screening and Day 1 as defined by:\r\n\r\n               -  Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)  4, AND\r\n\r\n               -  Spinal pain  4 (based on BASDAI question 2)\r\n\r\n          -  Have a history of inadequate response or intolerance to NSAIDs for the treatment of AS\r\n\r\n          -  If using allowed conventional synthetic disease-modifying antirheumatic drugs\r\n             (csDMARDs), NSAID, or corticosteroid therapy, must have been on stable doses (as\r\n             outlined in protocol) prior to Day 1\r\n\r\n        Key Exclusion Criteria:\r\n\r\n          -  Prior exposure to a Janus kinase (JAK) inhibitor > 2 doses\r\n\r\n          -  Total ankylosis of the spine\r\n\r\n          -  Any active/recent infection, as specified in the protocol\r\n\r\n          -  Diagnosis of fibromyalgia\r\n\r\n          -  Any musculoskeletal disorder other than AS that would interfere with assessment of\r\n             study parameters, as per judgement of investigator\r\n\r\n               -  Note: Prior history of reactive or other types of inflammatory arthritis is\r\n                  permitted if there is documentation of change in diagnosis to AS or additional\r\n                  diagnosis of AS\r\n\r\n          -  Any history of an inflammatory arthritis with onset age before 16 years old\r\n\r\n        Note: Other protocol defined Inclusion/Exclusion criteria may apply.\r\n      ","sponsor":"Gilead Sciences","sponsor_type":"Industry","conditions":"Ankylosing Spondylitis","interventions":[{"intervention_type":"Drug","name":"Drug: Filgotinib","description":"Tablets administered orally once daily"},{"intervention_type":"Drug","name":"Drug: Placebo to Match Filgotinib","description":"Tablets administered orally once daily"}],"outcomes":[{"outcome_type":"secondary","measure":"Change From Baseline in Chest Expansion","time_frame":"Baseline and up to Week 16","description":"Chest expansion will be measured during maximal inspiration and maximal forced expiration at the fourth intercostal space."},{"outcome_type":"primary","measure":"Proportion of Participants Who Achieve an Assessment of SpondyloArthritis international Society 40% Improvement (ASAS40) Response at Week 16","time_frame":"Week 16","description":"The ASAS40 calculation involves the analysis of 4 domains: participant's global assessment of disease activity, spinal pain (derived from the spinal pain questionnaire), function (derived from Bath Ankylosing Spondylitis Functional Index (BASFI) score), and inflammation (derived from morning stiffness questions from Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)). The ASAS40 is achieved if there is an improvement of ≥ 40% and ≥ 2 units in at least 3 domains on a scale of 10 with no worsening in the remaining domain."},{"outcome_type":"secondary","measure":"Proportion of Participants Who Achieve an ASAS40 Response","time_frame":"Up to Week 12","description":"The ASAS40 calculation involves the analysis of 4 domains: participant's global assessment of disease activity, spinal pain (derived from the spinal pain questionnaire), function (derived from BASFI score), and inflammation (derived from morning stiffness questions from BASDAI). The ASAS40 is achieved if there is an improvement of ≥ 40% and ≥ 2 units in at least 3 domains on a scale of 10 with no worsening in the remaining domain."},{"outcome_type":"secondary","measure":"Proportion of Participants Who Achieve an Assessment of SpondyloArthritis international Society 20% Improvement (ASAS20) Response","time_frame":"Up to Week 16","description":"The ASAS20 calculation involves the analysis of 4 domains: participant's global assessment of disease activity, spinal pain (derived from the spinal pain questionnaire), function (derived from BASFI score), and inflammation (derived from morning stiffness questions from BASDAI).The ASAS20 is achieved if there is an improvement of ≥ 20% and ≥ 1 units in at least 3 domains on a scale of 10 with no worsening of ≥ 20% and ≥ 1 unit in the remaining domain."},{"outcome_type":"secondary","measure":"Proportion of Participants who achieve Ankylosing Spondylitis Disease Activity Score (ASDAS) Low Disease Activity (LDA) (ie, ASDAS < 2.1) at Week 16","time_frame":"Week 16","description":"ASDAS is a composite score of 5 domains: total back pain, peripheral pain and/or swelling, duration of morning stiffness (derived from BASDAI questionnaire), participant's global assessment of disease activity, and serum high-sensitivity C-reactive protein (hsCRP). The ASDAS has a continuous scale from 0 with no defined upper end. A lower score indicate lower disease activity. ASDAS LDA is achieved when ASDAS < 2.1."},{"outcome_type":"secondary","measure":"Proportion of Participants Who Achieve an ASAS 5/6 Response","time_frame":"Up to Week 16","description":"The ASAS 5/6 is achieved when at least 20% improvement in at least 5 out of 6 domains. The 6 domains to use are: participant's global assessment of disease activity, spinal pain (derived from the spinal pain questionnaire), function (derived from BASFI score), inflammation (derived from morning stiffness questions from BASDAI), lateral spinal flexion (Bath Ankylosing Spondylitis Metrology Index (BASMI) question 1), and hsCRP."},{"outcome_type":"secondary","measure":"Change from Baseline in the Individual Components of the ASAS Core Set","time_frame":"Baseline and up to Week 16","description":"ASAS core set consists of 6 assessment domains: (1) participant's global assessment of disease activity, (2) spinal pain (derived from the spinal pain questionnaire), (3) function (derived from BASFI score), (4) inflammation (derived from morning stiffness questions from BASDAI), (5) hsCRP, (for these 5 domains, a lower score indicate lower disease activity) and (6) lateral spinal flexion (BASMI question 1) (for this 6th domain; a higher score indicate lower disease activity)."},{"outcome_type":"secondary","measure":"Proportion of Participants Who Achieve a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50% Improvement Response","time_frame":"Up to Week 16","description":"BASDAI consists of 6 items asking participants to report their fatigue, spinal pain, peripheral arthritis, enthesitis, intensity, and duration of morning stiffness during the past week on a 0 to 10 numeric rating scale. The total score ranges 0-10; scores of 4 or greater suggest suboptimal control of disease. BASDAI 50% improvement is achieved when a decrease in BASDAI versus baseline by at least 50%."},{"outcome_type":"secondary","measure":"Change From Baseline in ASDAS","time_frame":"Baseline and up to Week 16","description":"ASDAS is a composite score of 5 domains: total back pain, peripheral pain and/or swelling, duration of morning stiffness (derived from BASDAI questionnaire), participant's global assessment of disease activity, and hsCRP. The ASDAS has a continuous scale from 0 with no defined upper end. A lower score indicates lower disease activity."},{"outcome_type":"secondary","measure":"Change From Baseline in BASDAI","time_frame":"Baseline and up to Week 16","description":"BASDAI consists of 6 items asking participants to report their fatigue, spinal pain, peripheral arthritis, enthesitis, intensity, and duration of morning stiffness during the past week on a 0 to 10 numeric rating scale. The total score ranges 0-10; scores of 4 or greater suggest suboptimal control of disease."},{"outcome_type":"secondary","measure":"Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)","time_frame":"Baseline and up to Week 16","description":"The BASFI evaluates physical function in AS. The instrument consists of 10 items, rated on a 0 to 10 numeric rating scale (NRS), where 0 represents \"easy\" and 10 represents \"impossible.\" Among the 10 items, 8 items evaluate basic activities of daily living (putting on socks, bending, reaching up, 2 items on getting up, standing, climbing steps, and looking over shoulder) and 2 items assess participants' ability to cope with everyday life (physically demanding activities and full day's activities). The total score ranges 0-10, and the higher the score, the higher the functional impairment."},{"outcome_type":"secondary","measure":"Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) (Linear Score)","time_frame":"Baseline and up to Week 16","description":"The BASMI combines 5 measures: lateral spinal flexion, tragus-to-wall distance, lumbar flexion (modified Schober index), maximal intermalleolar distance, and cervical rotation. The BASMI will be scored using a linear function that will quantify the mobility of the axial skeleton and allow for objective assessment of clinically significant changes in spinal movement. The total score ranges 0-10, and the higher the score, the more severe the participant's limitation on movement."},{"outcome_type":"secondary","measure":"Change From Baseline in Occiput-to-wall Distance","time_frame":"Baseline and up to Week 16","description":"Occiput-to-wall distance is measured twice with the participant's heels and back rested against the wall. The chin should be at usual carrying level and the participant takes maximal effort to touch the head against the wall. The distance between the occiput and the wall is assessed and the better of the 2 assessments is to be reported."},{"outcome_type":"secondary","measure":"Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES), in Participants With Enthesitis at Baseline","time_frame":"Baseline and up to Week 16","description":"MASES is based on enthesitis grading of 13 body sites. The MASES is the sum of all site scores and ranges from 0-13. The higher the score, the higher the presence of enthesitis."},{"outcome_type":"secondary","measure":"Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL)","time_frame":"Baseline and up to Week 16","description":"The ASQoL assesses health-related quality of life in AS participants. The questionnaire consists of 18 yes/no questions. A single point will be assigned for each \"yes\" response, resulting in a total score between 0 and 18, with lower scores indicating a better quality of life."},{"outcome_type":"secondary","measure":"Change From Baseline in Assessment of SpondyloArthritis international Society Health Index (ASAS HI)","time_frame":"Baseline and up to Week 16","description":"The ASAS HI is a 17-item patient-reported outcome measure to assess the impact of interventions for spondyloarthritis (SpA), including axial SpA. Each item consists of a question with a binary response of either \"I agree\" (scored as 1) or \"I do not agree\" (scored as 0). The scoring is performed by summing the number of \"yes\" answers. The total sum of the ASAS HI ranges 0-17, with a lower score indicating a better health status."},{"outcome_type":"secondary","measure":"Change From Baseline in Physical Component Summary (PCS) Score of the 36-Item Short-Form Survey (SF-36) Version 2","time_frame":"Baseline and up to Week 16","description":"The SF-36 Version 2 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health perceptions, mental health, social functioning, vitality, and 2 component scores (Mental Component Summary (MCS) score and PCS). MCS consists of social functioning, vitality, mental health, and role-emotional. PCS consists of physical functioning, bodily pain, role-physical, and general health perceptions. Each domain will be scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning."},{"outcome_type":"secondary","measure":"Change From Baseline in Mental Component Summary (MCS) Score of the SF-36 Version 2","time_frame":"Baseline and up to Week 16","description":"The SF-36 Version 2 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health perceptions, mental health, social functioning, vitality, and 2 component scores (MCS and PCS). MCS consists of social functioning, vitality, mental health, and role-emotional. PCS consists of physical functioning, bodily pain, role-physical, and general health perceptions. Each domain will be scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning."},{"outcome_type":"secondary","measure":"Change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue)","time_frame":"Baseline and up to Week 16","description":"The FACIT-Fatigue measures an individual's level of fatigue during their usual daily activities during the past week. It consists of 13 questions on a 5-point Likert scale, with 0 indicating \"not at all\" and 4 indicating \"very much\". Negatively stated items are reversed and the total score ranges 0-52. Low scores indicate more severe fatigue than high scores."},{"outcome_type":"secondary","measure":"Change From Baseline in Work Productivity and Activity Impairment for Ankylosing Spondylitis (WPAI-AS)","time_frame":"Baseline and up to Week 16","description":"The WPAI-AS is a questionnaire developed to measure impairments in work activities in participants with AS. The questionnaire consists of 6 questions (currently employed, work time missed due to AS, work time missed due to other reasons, hours actually worked, degree AS affected productivity while working [0-10 NRS; with 0 indicating no effect and 10 indicating AS completely prevented the participant from working], and degree AS affected productivity in regular unpaid activities [0-10 NRS; with 0 indicating no effect and 10 indicating AS completely prevented the participant's daily activities]). The recall period for questions 2 through 6 is 7 days.\r\nFour main outcomes (expressed in percentages) can be obtained from the WPAI-AS: percentage of work time missed due to AS, percentage of impairment due to AS, percentage of overall work impairment due to AS, and percentage of activity impairment due to AS. Higher numbers indicate greater impairment and less productivity."},{"outcome_type":"secondary","measure":"Change From Baseline in EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)","time_frame":"Baseline and up to Week 16","description":"The EQ-5D-5L is a standard measure of health-related quality of life. The tool consists of the EQ-5D-5L descriptive system and the EQ visual analogue scale (VAS). The descriptive part comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each of these 5 dimensions has 5 levels (no problem, slight problems, moderate problems, severe problems, and extreme problems). Results for each of the 5 dimensions are combined into a 5-digit number to describe the participant's health state. The VAS records the participant's health on a 0-100 mm VAS scale, with 0 indicating \"the worst health you can imagine\" and 100 indicating \"the best health you can imagine.\" Higher scores of EQ VAS indicate better health."}]}
{"nct_id":"NCT04792684","start_date":"2020-12-30","enrollment":1100,"brief_title":"Collection of Samples USOPTIVAL Study","official_title":"Collection of Samples From the United States Population for Optimization and Evaluation of Colorectal Cancer (CRC) Plasma Circulating Free-DNA (cfDNA) Marker Panel Performance (\"USOPTIVAL\")","primary_completion_date":"2021-12-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2021-12-31","last_update":"2021-03-11","description":"A prospective multi-center observational study. The study will enroll eligible subjects from the United States to optimize the biomarker panel and evaluate the performance of a cfDNA marker panel selected by the Sponsor for CRC and advanced adenoma detection.","other_id":"CRC-US-001","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":45,"maximum_age":84,"population":"Two cohorts of patients aged between 45 and 84, who have a suspected advanced adenoma or\r\n        have been newly diagnosed with CRC, still not resected and scheduled for surgery, and\r\n        patients who are at average risk of developing colorectal cancer, scheduled for a\r\n        standard-of-care screening colonoscopy.\r\n\r\n        Subjects will be considered enrolled after understanding and signing the ICF and a\r\n        determination is made by the Investigator that the subject is eligible to participate\r\n        according to the inclusion/exclusion criteria.\r\n\r\n        Enrollment will be stopped when a sufficient number of confirmed cases of colorectal\r\n        cancer, advanced adenomas, and matching control subjects have been enrolled. Under the\r\n        current assumptions, 1,200 subjects will need to be enrolled.","criteria":"\n        Inclusion Criteria:\r\n\r\n        Arm A:\r\n\r\n          1. Must be 45-84 years of age.\r\n\r\n          2. Must have a suspected advanced adenoma or be newly diagnosed with CRC, still not\r\n             resected, and scheduled for surgery.\r\n\r\n          3. Able to comprehend, sign, and date the written informed consent document.\r\n\r\n        Arm B:\r\n\r\n          1. Must be 45-84 years of age.\r\n\r\n          2. Able and willing to undergo a standard-of-care screening colonoscopy within 60 days.\r\n\r\n          3. Able to comprehend, sign, and date the written informed consent document.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Arm A Only:\r\n\r\n        1. Subject with curative biopsy during colonoscopy.\r\n\r\n        Arm B Only:\r\n\r\n          1. Subjects with positive FIT Test results in the 6 months preceding enrollment.\r\n\r\n          2. Subject has a current diagnosis of cancer.\r\n\r\n        Arms A & B:\r\n\r\n          1. Subject has a personal history of aerodigestive or digestive tract cancers.\r\n\r\n          2. Subjects having undergone previous partial surgical removal of one or more portions of\r\n             their colon due to a reason other than colorectal cancer.\r\n\r\n          3. Has a known diagnosis or personal history of any of the following high-risk\r\n             indications for colorectal cancer:\r\n\r\n               1. Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and\r\n                  Crohn's disease.\r\n\r\n               2. Familial adenomatous polyposis (\"FAP\", including attenuated FAP).\r\n\r\n               3. Hereditary non-polyposis colorectal cancer syndrome (\"HNPCC\" or \"Lynch\r\n                  Syndrome\").\r\n\r\n               4. Serrated polyposis syndrome\r\n\r\n               5. 2 first-degree relatives (e.g., parents, siblings, and offspring) who have been\r\n                  diagnosed with colon cancer.\r\n\r\n               6. One first-degree relative with CRC diagnosed before the age of 60.\r\n\r\n          4. A significant disease which, in the Investigator's opinion, would exclude the subject\r\n             from the study.\r\n\r\n          5. Legal incapacity or limited mental capacity.\r\n\r\n          6. Medical or psychological conditions that would not permit the subject to complete the\r\n             study or sign informed consent.\r\n\r\n          7. The patient has a known or documented previous or current medical history of\r\n             infectious diseases that can be transmitted through blood (E.g. Hepatitis, HIV, etc.),\r\n             including patients that have been treated, are currently being treated, or have not\r\n             been treated for that conditions.\r\n\r\n          8. The patient is known to be pregnant when recruited or during her participation in the\r\n             study.\r\n      ","sponsor":"Universal Diagnostics","sponsor_type":"Industry","conditions":"Colorectal Cancer (CRC)|Advanced Adenomas (AA)","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Optimization of Plasma Circulating Free-DNA (cfDNA) Marker Panel","description":"Evaluate the performance of a preliminary panel of biomarkers"}],"outcomes":[{"outcome_type":"primary","measure":"Samples Collected for Plasma Circulating Free-DNA (cfDNA) Marker Testing","time_frame":"Within 12 months of sample collection","description":"Samples Collected for Testing"}]}
{"nct_id":"NCT04667767","start_date":"2020-12-22","phase":"N/A","enrollment":2000,"brief_title":"The TISA Trial - Senegal","official_title":"TISA (Traitement Intgr de la Sous-Nutrition Aigu) Trial : A Cluster Randomized Controlled Trial for the Effect of a WASH Kit Combined With Standard Outpatient Treatment on Severe Acute Malnutrition Recovery in Senegal","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-12-31","last_update":"2021-01-05","description":"This study evaluates the addition of a simple, scalable \"WASH kit\", including household water treatment products, a safe water storage container, and hygiene promotion, to the standard national protocol for outpatient treatment of uncomplicated severe acute malnutrition among children aged 6-59 months of age in northern Senegal.","other_id":"2019-KEP-267","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":0.5,"maximum_age":4.91667,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Weight-for-height z-score <-3; or\r\n\r\n          -  Brachial perimeter (mid-upper arm circumference) <115; or\r\n\r\n          -  Bilateral oedema\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Not able and/or willing to participate for up to 8-weeks\r\n\r\n          -  Clinical complications requiring referral and/or inpatient treatment\r\n      ","sponsor":"London School of Hygiene and Tropical Medicine","sponsor_type":"Other","conditions":"Severe Acute Malnutrition","interventions":[{"intervention_type":"Other","name":"Other: WASH kit","description":"WASH kit containing a plastic container and a supply of Aquatabs (effervescent chlorine tablets) and training in their use and associated hygiene practices."},{"intervention_type":"Other","name":"Other: Standard treatment","description":"National standard outpatient treatment for uncomplicated severe acute malnutrition"}],"outcomes":[{"outcome_type":"primary","measure":"Rate of recovery","time_frame":"8 weeks","description":"Recovery defined as two consecutive weeks with weight-for-height z-scores ≥ -1.5, if admitted based on weight-for-height z-score, or brachial perimeter (mid-upper arm circumference) ≥ 125 mm, if admitted based on brachial perimeter, and no oedema."},{"outcome_type":"secondary","measure":"Weight gain","time_frame":"8 weeks","description":"Weight gain defined as grams of weight gained per kilogram per day between entry and exit."},{"outcome_type":"secondary","measure":"Rate of referral","time_frame":"8 weeks","description":"Referral rate defined as number of participants referred/transferred to next level of care."},{"outcome_type":"secondary","measure":"Longitudinal prevalence of diarrhoea","time_frame":"8 weeks","description":"Longitudinal prevalence is defined by weeks with diarrhoea during follow-up with diarrhoea defined according to WHO definition (3 or more loose or liquid stools passed within 24 hours)."},{"outcome_type":"secondary","measure":"Prevalence of enteric pathogen detection","time_frame":"8 weeks","description":"Enteric pathogen detection by stool-based molecular assays of following pathogens: Adenovirus F(40/41), Astrovirus, Norovirus GI, Norovirus GII, Rotavirus, Sapovirus, Enteroaggregative E. coli (EAEC), Shiga-like toxin producing E. coli (STEC), Enteropathogenic Escherichia coli (EPEC), Enterotoxigenic E. coli (ETEC), Shigella/ Enteroinvasive Escherichia coli (EIEC), Campylobacter jejuni/coli, Salmonella enterica, Salmonella enterica Typhi, Vibrio cholerae, Clostridioides difficile, Yersinia enterocolitica, E. coli O157, Aeromonas, Helicobacter pylori, Cryptosporidium spp., Giardia spp., Entamoeba histolytica, Ascaris lumbricoides, Trichuris trichiura, Ancylostoma duodenale, Necator americanus, Strongyloides stercolaris, Plesiomonas shigelloides, Shigella flexneri, Shigella sonnei, Cyclospora cayetanensis."},{"outcome_type":"secondary","measure":"All cause mortality","time_frame":"8 weeks","description":"Deaths occurring during follow-up due to any cause."}]}
{"nct_id":"NCT04197674","start_date":"2020-12-20","enrollment":903,"brief_title":"China Q Cohort Study","official_title":"China Q Cohort Study: an Extended Follow-up Study of PD vs. HD Randomized Trial","primary_completion_date":"2021-12-31","study_type":"Observational","rec_status":"Not yet recruiting","completion_date":"2021-12-31","last_update":"2020-10-22","description":"The burden of end-stage kidney disease (ESKD) is increasing worldwide. Although kidney transplantation is the most cost-effective renal replacement therapy, dialysis is still the main way to treat ESRD patients due to the limited kidney donor, with approximately 89% of such dialysis patients receive hemodialysis (HD) and the remainder receive peritoneal dialysis (PD). This distribution of dialysis modality, however, varies widely by health jurisdiction. For instance, more than 97% of dialysis patients are treated with HD in Japan, but more than 50% treated with PD in Mexico. Evidence comparing the two modalities suggests that mortality risks may be comparable, but all evidence come from observational study and there is no randomized controlled trial to compare patient survival between PD and HD due to patients enrollment issue.More importantly, for most health care systems, such as United States, United Kingdom, Australia, Indonesia and China, PD is less expensive than HD. It is possible, then, that a greater global utilization of PD might improve access to renal replacement therapy in less advanced economies. The investigators have conducted a prospective, randomized, parallel, open-label, multi-center, non-inferiority trial to evaluate health-related quality of life (HRQoL) with PD versus conventional in-center HD in incident ESKD patients. A total of 1082 ESKD patients were randomly assigned to PD or conventional in-center HD, and 235 patients enrolled in stage 1 with complete measures of the \"Burden of Kidney Disease\" at both baseline and 48 weeks and 668 patients enrolled in stage 2 were included in analysis. However, this trial was designed to evaluate quality of life between PD and HD and all patients were follow-up 48 weeks. Therefore, in this observational cohort study, the investigators will perform extended follow-up for participants including in analysis . Our primary objective is to evaluate the association of dialysis modality (PD and HD) with all-cause mortality in ESKD patients. The investigators also explore the impact of PD and HD on major cardiovascular event composite (MACE), a composite outcome of MACE and all-cause death, hospitalized myocardial infarction, hospitalized stroke and hospitalized heart failure, healthy utility, dialysis cost, activity of daily living, and changes of RRF, hemoglobin, and other biochemical parameters.","other_id":"China Q Cohort","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"End stage kidney disease patients who randomly assigned to receive peritoneal dialysis and\r\n        conventional in-center hemodialysis","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adult (age  18 years old) peritoneal dialysis or in-center hemodialysis patient who\r\n             have been recruited in previous China Q study and who enrolled in SURinD study with\r\n             complete measures of the \"Burden of Kidney Disease\" at both baseline and 48 weeks.\r\n\r\n          -  Will and able to provide the informed consent form (ICF).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients have stopped dialysis due to kidney function recovery or kidney\r\n             transplantation.\r\n\r\n          -  Patients refuse to provide consent.\r\n      ","sponsor":"Sun Yat-sen University","sponsor_type":"Other","conditions":"End Stage Renal Disease on Dialysis|Peritoneal Dialysis|Hemodialysis","interventions":[{"intervention_type":"Other","name":"Other: Dialysis modality","description":"This is a observational cohort study, and there is no intervention for all participants. Our aim is to evaluate dialysis modality (PD and HD) on patient survival"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants died due to any cause","time_frame":"From the first day receiving assigned treatment to the end of 3rd year follow-up","description":"Patients died due to any cause"},{"outcome_type":"secondary","measure":"Number of Participants with major cardiovascular event composite (MACE)","time_frame":"From the first day receiving assigned treatment to the end of 3rd year follow-up","description":"MACE defined as defined as the first occurrence of myocardial infarction, ischemic stroke or death from cardiovascular causes"},{"outcome_type":"secondary","measure":"Number of Participants with composite outcome of MACE and all-cause death","time_frame":"From the first day receiving assigned treatment to the end of 3rd year follow-up","description":"Patients experience cardiovascular events and death."},{"outcome_type":"secondary","measure":"Number of Participants with hospitalized myocardial infarction, stroke and heart failure","time_frame":"From the first day receiving assigned treatment to the end of 3rd year follow-up","description":"Patients were hospitalized due to myocardial infarction, stroke and heart failure."},{"outcome_type":"secondary","measure":"Healthy utility","time_frame":"From the first day receiving assigned treatment to the end of 3rd year follow-up","description":"Healthy utility was assessed by Kidney Disease Quality of Life-Short Form (KDQoL-SF™, version 1.3) questionnaire domain of General health, with a range of 1 to 100 and higher value indicates better healthy utility"},{"outcome_type":"secondary","measure":"Rate of difference in dialysis cost between PD and HD","time_frame":"From the first day receiving assigned treatment to the end of 3rd year follow-up","description":"Dialysis cost is evaluated by budget impact model which is developed by Baxter Healthcare Corporation and is a excel based calculator with higher value indicates higher cost"},{"outcome_type":"secondary","measure":"Changes of activity of daily living","time_frame":"From the first day receiving assigned treatment to the end of 3rd year follow-up","description":"Activity of daily living assessed using Activrty Daily Living (ADL) scale, with a range of 14 to 56 and a score < 14 indicates independent daily living and a higher score indicates serious dependent daily living."},{"outcome_type":"secondary","measure":"Changes of residual renal function","time_frame":"From the first day receiving assigned treatment to the end of 3rd year follow-up","description":"Residual renal function was evaluated using 24h urine volume and the unit is ml."},{"outcome_type":"secondary","measure":"Changes of hemoglobin","time_frame":"From the first day receiving assigned treatment to the end of 3rd year follow-up","description":"The unit of hemoglobin is g/L."},{"outcome_type":"secondary","measure":"Changes of serum phosphors","time_frame":"From the first day receiving assigned treatment to the end of 3rd year follow-up","description":"The unit of serum phosphors is mmol/L."},{"outcome_type":"secondary","measure":"Changes of serum albumin","time_frame":"From the first day receiving assigned treatment to the end of 3rd year follow-up","description":"The unit of serum albumin is g/L."}]}
{"nct_id":"NCT04524663","start_date":"2020-12-19","phase":"Phase 2","enrollment":48,"brief_title":"Oral Camostat Compared With Standard Supportive Care in Mild-Moderate COVID-19 Patients","official_title":"A Phase 2 Randomized, Double Blinded, Placebo Controlled Study of Oral Camostat Mesilate Compared to Standard of Care in Subjects With Mild-Moderate COVID-19","primary_completion_date":"2021-05-15","study_type":"Interventional","rec_status":"Completed","completion_date":"2021-05-15","last_update":"2021-06-11","description":"This study will evaluate the efficacy of oral Foipan (camostat mesilate) compared with the current standard of care in reducing the duration of viral shedding of SARS-CoV-2 virus in patients with mild-moderate COVID-19 disease. Patients will attend 4 study visits over a period of up to 28 days.","other_id":"56029","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosis of COVID-19 disease as presence of mild-moderate symptoms without signs of\r\n             respiratory distress, with FDA-cleared molecular diagnostic assay positive for\r\n             SARS-CoV-2 within 72 hours prior to informed consent\r\n\r\n          -  Males must be sterile, OR agree not to donate semen AND agree to strictly adhere to\r\n             contraceptive measures during the study and for seven days following the last dose of\r\n             study medication\r\n\r\n          -  Females must be unable to bear children, OR ensure that their male partner is\r\n             incapable of fathering a child, OR, if of childbearing potential will strictly adhere\r\n             to contraceptive measures during the study and for seven days following the last dose\r\n             of study medication\r\n\r\n          -  Females must agree to stop breast-feeding prior to first dose of study drug and\r\n             through seven days after completing therapy\r\n\r\n          -  Females must have a negative pregnancy test at screening\r\n\r\n          -  Participant agrees to maintain home or other quarantine as recommended by the study\r\n             physician, except to visit the study site as required by the protocol\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Concomitant bacterial respiratory infection documented by respiratory culture. NOTE:\r\n             Subjects on empirical antibiotic treatment for possible but unproven bacterial\r\n             pneumonia, but who are positive for SARS-CoV-2, are allowed in the study.\r\n\r\n          -  Previous use of antiviral drugs that may be active against Covid-19.\r\n\r\n          -  Abnormal laboratory test results at screening:\r\n\r\n          -  Use of adrenocorticosteroids (except topical or inhaled preparations or oral\r\n             preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive\r\n             or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins,\r\n             interleukin antagonists or interleukin receptor blockers). NOTE: Treatment of study\r\n             participants following institutional COVID-19 treatment policies or guidelines,\r\n             including the use of immunomodulatory medications, is permitted. This excludes\r\n             treatment with agents that have the potential for direct antiviral activity, including\r\n             convalescent plasma and NO, and co-enrollment into other clinical studies that\r\n             evaluate investigational agents for COVID-19.\r\n\r\n          -  Serious chronic disease (e.g., human immunodeficiency virus [HIV], cancer requiring\r\n             chemotherapy within the preceding 6 months, and/or moderate or severe hepatic\r\n             insufficiency).\r\n\r\n          -  Previously received camostat mesilate within the past 30 days.\r\n\r\n          -  Advanced kidney disease\r\n\r\n          -  Advanced liver disease\r\n\r\n          -  History of alcohol or drug abuse in the previous 6 months.\r\n\r\n          -  Psychiatric illness that is not well controlled (defined as stable on a regimen for\r\n             more than one year).\r\n\r\n          -  Taken another investigational drug within the past 30 days.\r\n\r\n          -  Seemed by the Investigator to be ineligible for any reason.\r\n      ","sponsor":"Stanford University","sponsor_type":"Other","conditions":"Covid19","interventions":[{"intervention_type":"Drug","name":"Drug: Camostat Mesilate","description":"Camostat Mesilate administered as oral tablets"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo to match camostat mesilate"},{"intervention_type":"Other","name":"Other: Standard of Care Treatment","description":"Standard of Care Treatment for COVID-19 Infection"}],"outcomes":[{"outcome_type":"primary","measure":"Time until cessation of shedding of SARS-CoV-2 virus","time_frame":"Up to 28 days","description":"This outcome is defined as the time in days from randomization to the first of two consecutive negative RT-PCR results of self-collected nasal swabs."},{"outcome_type":"secondary","measure":"Clinical worsening of COVID-19 disease in symptomatic patients","time_frame":"Up to 28 days","description":"Number of symptomatic patients with clinical worsening, defined as the development of respiratory distress or symptoms that require hospitalization."},{"outcome_type":"secondary","measure":"Development of antibodies to SARS-CoV-2","time_frame":"Up to 28 days","description":"Number of patients that develop antibodies to SARS-CoV-2."},{"outcome_type":"secondary","measure":"Time until resolution of symptoms","time_frame":"Up to 28 days","description":"This outcome is defined as absence of moderate or severe symptoms for at least 24 hours for those reporting moderate or severe symptoms at baseline"},{"outcome_type":"secondary","measure":"Time until progression of symptoms","time_frame":"Up to 28 days","description":"Progression of respiratory symptoms defined as a two-level increase of a symptom on the Daily Symptom Status Questionnaire within a 24 hour period, or a one-level increase of a symptom on the Daily Symptom Status Questionnaire observed/sustained for a consecutive 48 hour period."},{"outcome_type":"secondary","measure":"Drug level on day five, one hour after a dose taken on an empty stomach","time_frame":"Day 5, 1 hour post dose"}]}
{"nct_id":"NCT04647708","start_date":"2020-12-16","phase":"Phase 1","enrollment":44,"brief_title":"Study of M5049 in CLE and SLE Participants","official_title":"A Phase Ib, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Safety and Pharmacokinetics of Multiple Ascending Doses of M5049 Administered Orally in SLE and CLE Participants Treated With Standard of Care","primary_completion_date":"2022-03-04","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-03-04","last_update":"2021-07-29","description":"This study is to evaluate the safety, tolerability and pharmacokinetics (PK) of orally administered M5049 in participants with systemic lupus erythematosus (SLE) or cutaneous lupus erythematosus (CLE).","other_id":"MS200569_0004","allocation":"Randomized","intervention_model":"Sequential Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Active systemic lupus erythematosus (SLE) with a Cutaneous lupus erythematosus disease\r\n             area and activity index (CLASI-A) greater than or equal to [>= ] 6 and/or at least one\r\n             active SLE clinical manifestation according to Systemic Lupus Erythematosus Disease\r\n             Activity Index 2000 (SLEDAI-2K)\r\n\r\n          -  Active cutaneous lupus erythematosus (CLE) (subacute cutaneous lupus erythematosus\r\n             and/or discoid lupus erythematosus) with a CLASI-A >= 6\r\n\r\n          -  Other protocol defined inclusion criteria could apply\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Autoimmune or rheumatic disease other than SLE or CLE\r\n\r\n          -  Dermatological diseases other than cutaneous manifestations of SLE or CLE\r\n\r\n          -  Uncontrolled medical conditions including significant cardiovascular events, active\r\n             lupus nephritis, and active neurological disorder\r\n\r\n          -  Ongoing or active clinically significant viral, bacterial or fungal infection\r\n\r\n          -  History of uncontrolled seizures or other neurological disorder\r\n\r\n          -  History of or positive for human immunodeficiency virus, hepatitis C virus, or\r\n             hepatitis B virus\r\n\r\n          -  History of malignancy\r\n\r\n          -  Other protocol defined exclusion criteria could apply\r\n      ","sponsor":"Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany","sponsor_type":"Industry","conditions":"Systemic Lupus Erythematosus|Cutaneous Lupus Erythematosus","interventions":[{"intervention_type":"Drug","name":"Drug: M5049","description":"Participants will receive low oral dose of M5049, twice daily in Part A."},{"intervention_type":"Drug","name":"Drug: M5049","description":"Participants will receive ascending oral dose of M5049, twice daily in Part A."},{"intervention_type":"Drug","name":"Drug: M5049","description":"Participants will receive high oral dose of M5049, twice daily in Part B."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Participants will receive placebo matched to M5049."}],"outcomes":[{"outcome_type":"primary","measure":"Part A: Cohort 1 and 2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Event of Special Interest (AESI), TEAEs Leading to Permanent Treatment Discontinuation and Treatment-Related TEAEs","time_frame":"Up to Day 102"},{"outcome_type":"primary","measure":"Part A: Cohort 3 and 4; Part B: Cohort 5: Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Event of Special Interest (AESI), TEAEs Leading to Permanent Treatment Discontinuation and Treatment-Related TEAEs","time_frame":"Up to Day 186"},{"outcome_type":"primary","measure":"Part A: Cohort 1 and 2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) Based on Severity","time_frame":"Up to Day 102"},{"outcome_type":"primary","measure":"Part A: Cohort 3 and 4; Part B: Cohort 5: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) Based on Severity","time_frame":"Up to Day 186"},{"outcome_type":"primary","measure":"Part A: Cohort 1 and 2: Number of Participants with Clinically Significant Changes from Baseline in Laboratory Parameters, Vital Signs, Electroencephalogram (EEG) and Electrocardiogram (ECG) Findings","time_frame":"Up to Day 102"},{"outcome_type":"primary","measure":"Part A: Cohort 3 and 4; Part B: Cohort 5: Number of Participants with Clinically Significant Changes from Baseline in Laboratory Parameters, Vital Signs, Electroencephalogram (EEG) and Electrocardiogram (ECG) Findings","time_frame":"Up to Day 186"},{"outcome_type":"primary","measure":"Part A: Cohort 1 and 2: Number of Participants with Confirmed Signs and Symptoms of Prodromal Seizure","time_frame":"Up to Day 102"},{"outcome_type":"primary","measure":"Part A: Cohort 3 and 4; Part B: Cohort 5: Number of Participants with Confirmed Signs and Symptoms of Prodromal Seizure","time_frame":"Up to Day 186"},{"outcome_type":"primary","measure":"Part A: Cohort 1 and 2: Number of Participants with Suicidal Behavior and Suicidal Ideation as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)","time_frame":"Up to Day 102"},{"outcome_type":"secondary","measure":"Part A and Part B: Maximum Observed Plasma Concentration (Cmax) of M5049","time_frame":"Pre-dose up to Day 85 for Cohort 1 and 2 of Part A, up to Day 169 for Cohort 3, 4 of Part A and Cohort 5 of Part B"},{"outcome_type":"secondary","measure":"Part A and Part B: Dose Normalized Maximum Observed Plasma Concentration (Cmax/Dose) of M5049","time_frame":"Day 1 and Day 29"},{"outcome_type":"secondary","measure":"Part A and Part B: Time to Reach Maximum Plasma Concentration (tmax) of M5049","time_frame":"Pre-dose up to Day 85 for Cohort 1 and 2 of Part A, up to Day 169 for Cohort 3, 4 of Part A and Cohort 5 of Part B"},{"outcome_type":"secondary","measure":"Part A and Part B: Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC0-t) of M5049","time_frame":"Pre-dose up to Day 85 for Cohort 1 and 2 of Part A, up to Day 169 for Cohort 3, 4 of Part A and Cohort 5 of Part B"},{"outcome_type":"secondary","measure":"Part A and Part B: Dose Normalized Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC0-t/Dose) of M5049","time_frame":"Day 1 and Day 29"},{"outcome_type":"secondary","measure":"Part A and Part B: Accumulation Ratio for Maximum Observed Plasma Concentration (Racc Cmax) of M5049","time_frame":"Pre-dose up to Day 85 for Cohort 1 and 2 of Part A, up to Day 169 for Cohort 3, 4 of Part A and Cohort 5 of Part B"},{"outcome_type":"secondary","measure":"Part A and Part B: Elimination Rate Constant (Lambda z) of M5049","time_frame":"Day 1 and Day 29"},{"outcome_type":"secondary","measure":"Part A and Part B: Apparent Terminal Half-life (t1/2) of M5049","time_frame":"Day 1 and Day 29"},{"outcome_type":"secondary","measure":"Part A and Part B: Area Under the Plasma Concentration-Time Curve From Time Zero to 12 Hours Post-Dose (AUC0-12h) of M5049","time_frame":"Day 29"},{"outcome_type":"secondary","measure":"Part A and Part B: Dose Normalized Area Under Plasma Concentration-Time Curve from Time Zero to 12 Hours Post-Dose (AUC0-12h/Dose) of M5049","time_frame":"Day 29"},{"outcome_type":"secondary","measure":"Part A and Part B: Total Body Clearance (CL/f) of M5049","time_frame":"Day 1"},{"outcome_type":"secondary","measure":"Part A and Part B: Apparent Volume of Distribution (Vz/f) of M5049","time_frame":"Day 1"},{"outcome_type":"secondary","measure":"Part A and Part B: Area Under Plasma Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC0-inf) of M5049","time_frame":"Day 1"},{"outcome_type":"secondary","measure":"Part A and Part B: Dose Normalized Area Under Plasma Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC0-inf/Dose) of M5049","time_frame":"Day 1"},{"outcome_type":"secondary","measure":"Part A and Part B: Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Activity Index (CLASI-A)","time_frame":"Baseline (Day 1) through Day 85 for Cohort 1 and 2 of Part A, Day 169 for Cohort 3, 4 of Part A and Cohort 5 of Part B"},{"outcome_type":"secondary","measure":"Part A and Part B: Change from Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)","time_frame":"Baseline (Day 1) through Day 85 for Cohort 1 and 2 of Part A, Day 169 for Cohort 3, 4 of Part A and Cohort 5 of Part B"},{"outcome_type":"secondary","measure":"Part A and Part B: Change from Baseline in 28-Joint Count","time_frame":"Baseline (Day 1) through Day 85 for Cohort 1 and 2 of Part A, Day 169 for Cohort 3, 4 of Part A and Cohort 5 of Part B"},{"outcome_type":"secondary","measure":"Part A and Part B: Change from Baseline in Physician Global Assessment (PGA) Score","time_frame":"Baseline (Day 1) through Day 85 for Cohort 1 and 2 of Part A, Day 169 for Cohort 3, 4 of Part A and Cohort 5 of Part B"}]}
{"nct_id":"NCT04631757","start_date":"2020-12-15","phase":"Phase 2","enrollment":33,"brief_title":"Conversion Therapy of Camrelizumab Plus Chemoradiotherapy in Participants With Initial Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma","official_title":"A Prospective, Non-randomized, Phase II Study of Camrelizumab in Combination With Concurrent Chemoradiotherapy for Initial Unresectable Proximal Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Conversion Therapy","primary_completion_date":"2022-06-30","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2023-12-31","last_update":"2020-11-17","description":"This is a study of Camrelizumab in Combination With concurrent radiotherapy and SOX for Initial Unresectable or potentially resectable proximal Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma. Patients without prior palliative therapy will be treated with Camrelizumab, radiotherapy (total 45 Gy), Oxaliplatin, and S-1. The primary endpoint is the 1-year PFS rate.","other_id":"MA-GC-II-006","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients who provided written informed consent to be subjects in this trial.\r\n\r\n          -  18-75 years old.\r\n\r\n          -  Has histologically-confirmed diagnosis of locally advanced unresectable or metastatic\r\n             gastric or GEJ adenocarcinoma.\r\n\r\n          -  The initial unresectable or potentially resectable locally advanced proximal gastric\r\n             carcinoma /Gastroesophageal Junction (GEJ) Adenocarcinoma (Siewert type II/III) in\r\n             clinical stage T3-4N+M0 (AJCC 8 edition TNM stage) under any following condition:\r\n             serious primary tumor invasion, unresectable bulky lymph node, retroperitoneal lymph\r\n             node metastasis (RPLM). Clinical staging was performed according to enhanced CT/MRI\r\n             examination.\r\n\r\n          -  No prior systemic chemotherapy for the treatment of the participant's advanced or\r\n             metastatic disease (include but not limited to surgery, radiotherapy, chemotherapy,\r\n             targeted therapy, immunotherapy)\r\n\r\n          -  Plan to have surgery after conversion therapy.\r\n\r\n          -  Patients capable of taking oral medication.\r\n\r\n          -  Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG)\r\n             Performance Scale.\r\n\r\n          -  Survival expectation 12 months.\r\n\r\n          -  Adequate organ function according to the following laboratory test results: absolute\r\n             neutrophil count (ANC) 1.5109/L; platelets 80109/L; hemoglobin 90g/L; total\r\n             bilirubin 1.5 ULN; serum creatinine 1.5 ULN or measured or calculated creatinine\r\n             clearance > 50ml/min.\r\n\r\n          -  Female subjects of childbearing potential must have a negative urine or serum\r\n             pregnancy test within 72 hours prior to receiving the first dose of study medication\r\n             and must be willing to use an adequate method of contraception for the course of the\r\n             study through 90 days after the last dose of study medication. Male subjects of\r\n             childbearing potential must agree to use an adequate method of contraception starting\r\n             with the first dose of study therapy through 90 days after the last dose of study\r\n             therapy.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  HER2 positive subjects will be excluded.\r\n\r\n          -  With evidence of abdominal metastases.\r\n\r\n          -  Has a known additional malignancy that is progressing within the past 5 years. Note:\r\n             Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the\r\n             skin, or carcinoma in situ that have undergone potentially curative therapy are not\r\n             excluded.\r\n\r\n          -  The presence of any of the following cardiac clinical symptoms or diseases: New York\r\n             Heart Association (NYHA) congestive heart failure of grade II or above, LVEF<50%,\r\n             unstable angina pectoris, myocardial infarction within the past 12 months, QTc  450ms\r\n             for male, QTc  450ms for female, electrocardiogram (ECG) examination revealed\r\n             clinically significant abnormalities, have factors that increase the risk of prolonged\r\n             QTc and abnormal heart rhythm.\r\n\r\n          -  With active infection requiring drug intervention (e.g. anti-bacterial drugs,\r\n             antiviral drugs, antifungal drugs treatment).\r\n\r\n          -  Patients with active hepatitis B (HBsAg positive and HBV DNA500 IU/ml), hepatitis C\r\n             (HCV antibodies positive and HCV RNA copies > ULN)\r\n\r\n          -  With congenital immune deficiency or human immunodeficiency virus (HIV) infection.\r\n\r\n          -  Plan to receive or have previously received an organ or allogeneic bone marrow\r\n             transplant.\r\n\r\n          -  Objective evidence of previous or current pulmonary fibrosis history, interstitial\r\n             pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, pulmonary\r\n             function damaged seriously etc; active tuberculosis (TB).\r\n\r\n          -  Patients with concurrent autoimmune disease, or a history of chronic or recurrent\r\n             autoimmune disease.\r\n\r\n          -  Who has received immunosuppressants/systemic corticosteroids therapy < 7 days before\r\n             the first dose for an immunosuppression purpose (> 10mg/day prednisone or other\r\n             equivalency drugs).\r\n\r\n          -  Has received a live vaccine within 28 days prior to the first dose, plan to receive a\r\n             live vaccine during or within 60 days after study treatment.\r\n\r\n          -  Have any contraindications for study treatment.\r\n\r\n          -  Participate in other clinical trials within 4 weeks before the first dose.\r\n\r\n          -  Is pregnant or breastfeeding.\r\n\r\n          -  Patients were judged unsuitable as subjects of this trial by investigators.\r\n      ","sponsor":"Tianjin Medical University Cancer Institute and Hospital","sponsor_type":"Other","conditions":"Gastric Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Camrelizumab + SOX + Radiotherapy","description":"Camrelizumab 200mg,d1,Q3w; oxaliplatin 130mg/m2, d1, Q3w; S-1 40-60mg bid, d1-d14,Q3w; intensity modulated radiotherapy 45Gy/25d"}],"outcomes":[{"outcome_type":"primary","measure":"1-year progression-free survival (PFS) rate according to RECIST 1.1 base on investigator assessment","time_frame":"Up to approximately 12 months","description":"PFS was defined as the time from the first dose to the first documented disease progression per RECIST 1.1 based on investigator assessment. PFS rate at 1 year as estimated by Kaplan-Meier method."},{"outcome_type":"secondary","measure":"progression-free survival (PFS) according to RECIST 1.1 base on investigator assessment","time_frame":"Up to approximately 36 months","description":"PFS was defined as the time from the first dose to the first documented disease progression per RECIST 1.1 based on investigator assessment."},{"outcome_type":"secondary","measure":"disease-free survival (DFS) Per RECIST 1.1 base on investigator assessment","time_frame":"Up to approximately 36 months","description":"DFS is defined as the time from post-surgery baseline scan until the first occurrence of local/distant recurrence or death from any cause and is based on RECIST 1.1 as assessed by investigators in patients undergoing surgery."},{"outcome_type":"secondary","measure":"rate of R0-resections","time_frame":"Up to 30 days post-sugery","description":"the percentage of participants undergoing surgery with resection margin status negative."},{"outcome_type":"secondary","measure":"Major pathological response（MPR）","time_frame":"Up to 30 days post-sugery","description":"The proportion of participants with a major pathological response (mPR) at the time of definitive surgery."},{"outcome_type":"secondary","measure":"Pathological Complete Response (pCR)","time_frame":"Up to 30 days post-sugery","description":"Pathological complete response (pCR) is measured as the proportion of participants with a pathological complete response at the time of definitive surgery."},{"outcome_type":"secondary","measure":"Overall Survival (OS)","time_frame":"Up to 5 years","description":"OS is the time from the first dose to death due to any cause."},{"outcome_type":"secondary","measure":"Percentage of Participants Experiencing An Adverse Event (AEs)","time_frame":"Up to approximately12 months","description":"An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocolspecified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an adverse event. The number of participants who experienced an AE was reported for each arm according to the treatment received. The grade of AE will be assessed per CTCAE 5.0."}]}
{"nct_id":"NCT04726930","start_date":"2020-12-15","enrollment":40,"brief_title":"Ultrasound Needle Transducer for Regional Anesthesia Validation Study","official_title":"High Frequency Ultrasound Spring-load Front-and-side Firing Needle Transducer Developments and Pre-clinical Regional Anesthesia Validation Study","primary_completion_date":"2021-12-15","study_type":"Observational","rec_status":"Active, not recruiting","completion_date":"2025-12-01","last_update":"2021-03-16","description":"To validate the efficacy of miniaturized ultrasound needle transducer as the primary guide for thoracic regional anesthesia.","other_id":"2020-04-003B","observational_model":"Other","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":20,"maximum_age":80,"population":"Patients admitted to Taipei Veterans General Hospital for elective thoracic, upper\r\n        abdominal, or breast surgeries will be invited to join this trial.","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patients scheduled for elective thoracic surgery\r\n\r\n          2. Patients scheduled for elective upper abdominal surgery\r\n\r\n          3. Patients scheduled for elective breast surgeries.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Known coagulopathies,\r\n\r\n          2. Skin lesion or infection at site of nerve block\r\n\r\n          3. Pregnant women\r\n\r\n          4. Allergic to local anesthetics\r\n\r\n          5. Cognitive diseases\r\n\r\n          6. Unstable hemodynamics\r\n\r\n          7. Chronic substance abuse (ex. alcohol, hypnotics, opioids)\r\n      ","sponsor":"Taipei Veterans General Hospital, Taiwan","sponsor_type":"Other","conditions":"Thorax; Pain, Spine, With Radicular and Visceral Pain|Acute Post-thoracotomy Pain|Pain, Postoperative|Ultrasound Therapy; Complications","interventions":[{"intervention_type":"Procedure","name":"Procedure: Intercostal nerve blocks","description":"Intercostal nerve block is a regional anesthetic procedure for peri-operative pain management. It inhibits the action of the ipsilateral sensory and motor branches, and produces analgesic effects at the targeted thoracic level."},{"intervention_type":"Procedure","name":"Procedure: Paravertebral block","description":"Paravertebral block is the technique of injecting local anesthetic alongside the thoracic vertebra close to where the spinal nerves emerge from the intervertebral foramen. This produces unilateral, segmental, somatic, and sympathetic nerve blockade, which is effective for anesthesia and in treating acute and chronic pain of unilateral origin from the chest and abdomen"}],"outcomes":[{"outcome_type":"primary","measure":"Needling time","time_frame":"Needle insertion to needle withdrawal, up to 20 minutes","description":"Needle insertion to needle withdrawal (minutes)"},{"outcome_type":"primary","measure":"Nerve block procedure time","time_frame":"Time from ultrasound contact with skin to needle withdrawal, up to 20 minutes","description":"How long the procedure takes in minutes, starting from ultrasound contact with skin to needle withdrawal"},{"outcome_type":"primary","measure":"Success rate of blockade","time_frame":"20 minutes post administration of local anesthetics (by ultrasound or cold sensation) or intraoperative (at the time of video-thoracoscope exploration)","description":"Successful blockade will be determined by 1.ultrasound evidence of ideal spreading or 2.evidence of fluid accumulation around intercostal nerves or at paravertebral space under thoracoscope, or 3. loss of cold sensation on the chest or abdomen at block level."},{"outcome_type":"primary","measure":"Visibility of needle tip and anatomic structure","time_frame":"During block procedure, up to 60 minutes.","description":"Record the visibility of needle tip, intercostal muscle, superior costotransverse ligament, pleura. Assessed by the inserting anesthetist on a 5 point Likert scale"},{"outcome_type":"secondary","measure":"Inadvertent pleural puncture or pneumothorax","time_frame":"20 minutes post-procedure or intraoperative (if needle injuries on pleura noted by thoracoscope)","description":"Calculate the rate of Inadvertent pleural puncture or pneumothorax, defined by image evidence of pleura injuries or pneumothorax by thoracoscope, X-ray, or CT."}]}
{"nct_id":"NCT04560114","start_date":"2020-12-14","phase":"Phase 2","enrollment":96,"brief_title":"Effect of Inhaled Aromatherapy on Chemo-Induced Nausea Vomiting (NCVI): CINVAROM (Chemotherapy Induced Nausea Vomiting and AROMatherapy)","official_title":"Effect of Inhaled Aromatherapy on Chemo-Induced Nausea Vomiting (NCVI): CINVAROM (Chemotherapy Induced Nausea Vomiting and AROMatherapy)","primary_completion_date":"2021-09-21","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2022-05-31","last_update":"2021-09-22","description":"The investigator wish to provide a blend of two essential oils with comparable antiemetic properties; Peppermint essential oil (Mentha x Piperita) and lemon tree essential oil (Citrus Limon). Dry inhalation of these essential oils is safe, but effectiveness has not been determined. Studies on the subject present a questionable methodology. This is why we are proposing this study to measure the effectiveness of this mixture of essential oils on chemo-induced nausea and vomiting. This study is a first step before a possible study to compare the effects of essential oils with those of a placebo.","other_id":"CINVAROM","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Open, prospective, single-center phase 2 study","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Patients will be eligible if:\r\n\r\n          -  Aged over 18,\r\n\r\n          -  Presenting a solid tumor in the 1st line of chemotherapy administered by intravenous\r\n             route;\r\n\r\n          -  Treated with adjuvant or neoadjuvant chemotherapy;\r\n\r\n          -  Affiliated with a social security scheme;\r\n\r\n          -  Able to understand the meaning of the questions asked;\r\n\r\n          -  Having given their written consent to participate in the study;\r\n\r\n          -  Whether or not treated with surgery and radiotherapy before entering the study\r\n\r\n        Exclusion Criteria:\r\n\r\n        Patients who:\r\n\r\n          -  Do not give their consent to participate;\r\n\r\n          -  Do not master the French language;\r\n\r\n          -  Are deprived of their liberty, under guardianship or curatorship;\r\n\r\n          -  Suffer from cognitive deficits or associated psychiatric disorders that could\r\n             compromise their ability to participate in the study (eg: schizophrenia);\r\n\r\n          -  Are undergoing radiotherapy;\r\n\r\n          -  Must receive a combination of radio-chemotherapy;\r\n\r\n          -  Whose chemotherapy protocol is composed of several chemotherapy administrations per\r\n             week during a course of treatment;\r\n\r\n          -  have been previously treated with chemotherapy;\r\n\r\n          -  Have an occlusive syndrome;\r\n\r\n          -  Have primary cancer of the central nervous system or brain metastases;\r\n\r\n          -  Have cancer of the Upper Aero Digestive Tract;\r\n\r\n          -  Simultaneously participate in a therapeutic clinical trial;\r\n\r\n          -  Have an intolerance to a component of essential oils;\r\n\r\n          -  Pregnant or breastfeeding.\r\n      ","sponsor":"Centre Francois Baclesse","sponsor_type":"Other","conditions":"Suportive Care|Essential Oil|Aromatherapy|Nausea and Vomiting","interventions":[{"intervention_type":"Drug","name":"Drug: Essential oils","description":"The patient will be invited to inhale the essential oils via the stick:\r\n4 times a day before each meal and snack.\r\nif necessary when nausea appears, as many times as he deems necessary."}],"outcomes":[{"outcome_type":"primary","measure":"Number of episodes of nausea and vomiting","time_frame":"4 days after the first cycle of chemotherapy"},{"outcome_type":"secondary","measure":"Number of episodes of nausea and vomiting","time_frame":"4 days after the third cycle"},{"outcome_type":"secondary","measure":"Anxiety with self-questionnaire HADS","time_frame":"21 days after the third cycle"}]}
{"nct_id":"NCT04651530","start_date":"2020-12-08","phase":"N/A","enrollment":100,"brief_title":"Endoscopic Cyclophotocoagulation in Normal Tension Glaucoma","official_title":"Endoscopic Cyclophotocoagulation in Normal Tension Glaucoma","primary_completion_date":"2025-12-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2026-12-01","last_update":"2020-12-22","description":"The purpose of this study is to assess whether endoscopic cyclophotocoagulation added to cataract surgery lowers intraocular pressure more than cataract surgery alone in patients with normal tension glaucoma.","other_id":"876543","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":55,"maximum_age":100,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Signed Informed Consent\r\n\r\n          -  Normal Tension Glaucoma with typical nerve fiber layer defects in red-free photographs\r\n             and/or optical coherence tomography (OCT) and possible equivalent visual field\r\n             defects, IOP never more than 21 mmHg, and open anterior chamber angle\r\n\r\n          -  Glaucoma stable with current medication assessed by a glaucoma specialist\r\n\r\n          -  Clinically significant cataract\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Secondary Glaucoma e.g. due to previous injury or uveitis\r\n\r\n          -  Exfoliation syndrome\r\n\r\n          -  Pigment dispersion syndrome\r\n\r\n          -  Previous transscleral or endoscopic cyclophotocoagulation\r\n\r\n          -  Previous other glaucoma surgery\r\n\r\n          -  Cataract due to eye injury or congenital cataract\r\n\r\n          -  Zonular weakness due to Marfan syndrome or other\r\n\r\n          -  Previous retinal detachment\r\n\r\n          -  Previous intraocular surgery like vitrectomy and other retinal surgery\r\n\r\n          -  Wet age-related macular degeneration\r\n\r\n          -  Diabetic retonopathy\r\n\r\n          -  Previous corneal transplant or previous refractive surgery\r\n\r\n          -  Fuchs' dystrophy and other abnormalities compromising corneal clarity like scars\r\n\r\n          -  The patient does not want to participate in the study\r\n\r\n          -  The glaucoma progresses on current IOP\r\n\r\n          -  The patient does not speak Finnish, Swedish or English\r\n\r\n          -  Dementia\r\n\r\n          -  Only eye with vision worse than 20/200 or loss of central visual field\r\n      ","sponsor":"Helsinki University Central Hospital","sponsor_type":"Other","conditions":"Normal Tension Glaucoma|Cataract","interventions":[{"intervention_type":"Procedure","name":"Procedure: Phaco","description":"phacoemulsification of cataract only"},{"intervention_type":"Procedure","name":"Procedure: Phaco+ECP","description":"Endoscopic cyclophotocoagulation is done in the same procedure as phacoemulsification of cataract"}],"outcomes":[{"outcome_type":"primary","measure":"Succes rate","time_frame":"One year postoperatively","description":"Success: Decrease in Intraocular Pressure (IOP) of 20 % or more or former level with fewer medications"},{"outcome_type":"secondary","measure":"Additional surgery","time_frame":"Five years postoperatively","description":"Comparison of the need for additional glaucoma surgery"}]}
{"nct_id":"NCT04685720","start_date":"2020-12-07","phase":"N/A","enrollment":20,"brief_title":"A Pilot Study to Assess the Effect of Intermittent iNO on the Treatment of NTM Lung Infection in CF and Non-CF Patients","official_title":"A Pilot Study to Assess the Effect of Intermittent Inhaled Nitric Oxide on the Treatment of Nontuberculous Mycobacteria (NTM) Lung Infection in Cystic Fibrosis and Non-Cystic Fibrosis Patients","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-05-31","last_update":"2020-12-28","description":"The purpose of this open-label, multicenter, non-randomized, pilot study is to assess the safety of high dose intermittent iNO for treatment of NTM infection in CF and non-CF patients.","other_id":"BA_NTM_AU_01.01","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subjects diagnosed with refractory NTM (MAC or MAbs) pulmonary infection\r\n\r\n          -  CF and Non-CF patients\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Diagnosis of methemoglobinemia or MetHb 2% at screening; treatment with any drug\r\n             known to increase MetHb; known or suspected hemoglobinopathy.\r\n\r\n          -  History of or current myeloproliferative disease, leukemia or other hematological\r\n             malignancy; known or suspected immunodeficiency disease.\r\n\r\n          -  Subjects with advanced cardiovascular disease or CHF\r\n\r\n          -  Use of an investigational drug during the 30 days prior to enrollment.\r\n\r\n          -  History of frequent epistaxis (>1 episode/month); significant hemoptysis (during the\r\n             30 days prior to enrollment.\r\n\r\n          -  Subject on non-constant dose of systemic steroids within 30 days prior to enrollment;\r\n             subjects on constant systemic steroids if the daily dose is higher than 10 mg/d\r\n             prednisolone or equivalent.\r\n\r\n          -  Active pulmonary malignancy (primary or metastatic) or any malignancy; history of lung\r\n             transplantation.\r\n\r\n          -  Pulmonary tuberculosis requiring treatment or treated within 2 years prior to\r\n             screening.\r\n\r\n          -  Uncontrolled hypertension within 3 months prior to or at screening\r\n\r\n          -  Diagnosis of significant pulmonary hypertension indicated on echocardiogram at\r\n             screening\r\n\r\n          -  Clinically significant renal or liver laboratory abnormalities\r\n\r\n          -  History of daily, continuous oxygen supplementation.\r\n\r\n          -  Women of childbearing potential - pregnant or breastfeeding, or not on medically\r\n             acceptable double methods of contraception from enrollment until Day 84.\r\n\r\n          -  Smoking tobacco or any substance within 6 months prior to screening or anticipated\r\n             inability to refrain from smoking throughout the study.\r\n\r\n          -  Patient receiving drugs that have a contraindication with NO\r\n      ","sponsor":"Beyond Air Inc.","sponsor_type":"Industry","conditions":"Non-Tuberculous Mycobacterial Pneumonia|Cystic Fibrosis|Mycobacterial Pneumonia|Mycobacterium Abscessus Infection|Mycobacterium Avium Complex","interventions":[{"intervention_type":"Device","name":"Device: LungFit","description":"LungFit for NTM is an experimental device that produces Nitric Oxide from the ambient air."}],"outcomes":[{"outcome_type":"primary","measure":"Treatment-Emergent SAEs","time_frame":"Day 1 to Day 84","description":"The primary endpoint of the study is the number of patients with treatment-emergent SAEs"},{"outcome_type":"secondary","measure":"Changes in NTM bacterial load from baseline to Day 174","time_frame":"Day 1 to Day 174","description":"Changes in NTM bacterial load will be assessed by sputum culture in liquid and solid media."},{"outcome_type":"secondary","measure":"Number of patients with culture conversion at Day 174","time_frame":"Day 1 to Day 174","description":"NTM culture conversion will be defined as having at least three consecutive negative NTM cultures"},{"outcome_type":"secondary","measure":"Changes in quality of life assessed by CFQ-R for or QOL-B with NTM module","time_frame":"Day 1 to Day 174","description":"Changes in quality of life assessed by Cystic Fibrosis Questionnaire Revised [CFQ R] for CF patients or Quality of Life Questionnaire-Bronchiectasis [QOL-B] with NTM module for non-CF patients."},{"outcome_type":"secondary","measure":"Changes in FEV1 from baseline to Day 174","time_frame":"Day 1 to Day 174","description":"Respiratory function will be assessed by spirometry including FEV1."},{"outcome_type":"secondary","measure":"Changes in activity tracker data as assessed by changes in distance from baseline to Day 174.","time_frame":"Day 1 to Day 174","description":"Patients will collect activity tracker data from 2 weeks before treatment and from Day 1 to Day 174."},{"outcome_type":"secondary","measure":"Change in 6 Minute Walking Test","time_frame":"Day 1 to Day 84","description":"Change in 6 Minute Walking Test will be assessed by changes in distance between baseline and Day 84"}]}
{"nct_id":"NCT04798430","start_date":"2020-12-03","phase":"Phase 3","enrollment":2000,"brief_title":"Long-term Efficacy and Safety of OLE LIB003 in HoFH, HeFH, and High-risk CVD Patients Requiring Further LDL-C Reduction","official_title":"Open-Label Extension Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of LIB003 in Patients With HoFH and HeFH, CVD, or at High Risk for CVD, on Stable Lipid-Lowering Therapy Requiring Additional LDL-C Reduction","primary_completion_date":"2023-12-30","study_type":"Interventional","rec_status":"Enrolling by invitation","completion_date":"2024-03-31","last_update":"2021-08-13","description":"The study is to assess the long-term safety, tolerability, and efficacy after 48 and 72 weeks with monthly (Q4W [<31 days]) dosing of subcutaneous (SC) LIB003 300 mg administered in patients with CVD or at high risk for CVD (including HoFH and HeFH) on stable diet and oral LDL-C lowering drug therapy who completed one of the LIB003 Phase 3 base studies.","other_id":"LIB003-007","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"open label extension trial","sampling_method":"","gender":"All","minimum_age":10,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Successful completion 1 of one of the Phase 3 base studies LIB003-003, LIB003-004,\r\n             LIB003-005, LIB003-006, LIB003-008, LIB003-011 and LIB003-012 without SAEs related to\r\n             LIB003; or\r\n\r\n          -  Provision of written and signed informed consent prior to any study-specific\r\n             procedure;\r\n\r\n          -  Female patients of childbearing potential must be using a highly effective form of\r\n             birth control if sexually active and have a negative urine pregnancy test on Day 1\r\n             prior to dosing;\r\n\r\n          -  Patient is willing to maintain appropriate diet and stable dose of current\r\n             lipid-lowering therapy including statins, ezetimibe, bile acid sequestrants, niacin,\r\n             bempedoic acid, bezafibrate or fenofibrate, and/or OM-3 compounds; and\r\n\r\n          -  Patient is considered by the Investigator to be otherwise healthy,\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Failure to complete a base Phase 3 (LIB003-003, LIB003-004, LIB003-005, LIB003-006,\r\n             LIB003-008, LIB003-011 and LIB003-012) study and/or had an SAE that was related to\r\n             study drug during the base Phase 3 study;\r\n\r\n          -  Development since the final visit in the base Phase 3 (LIB003-003, LIB003-004,\r\n             LIB003-005, LIB003-006, LIB003-008, LIB003-011 or LIB003-012) study of any concomitant\r\n             clinical condition or acute and/or unstable systemic disease compromising patient\r\n             inclusion, at the discretion of the Investigator,\r\n\r\n          -  Use of prohibited oral lipid-lowering agents PCSK9 mAbs, mipomersen, lomitapide\r\n             gemfibrozil (or bempedoic acid for LIB003, -011) following the base study or the use\r\n             of PCSK9 short interfering ribonucleic acid (siRNA), or locked nucleic acid-reducing\r\n             agents (LNA) within the last 6 months;\r\n\r\n          -  Not available for protocol-required study visits or procedures, to the best of the\r\n             patient's and Investigator's knowledge;\r\n\r\n          -  Has any other finding which, in the opinion of the Investigator, would compromise the\r\n             patient's safety or participation in the study;\r\n      ","sponsor":"LIB Therapeutics LLC","sponsor_type":"Industry","conditions":"Cardiovascular Disease With Mention of Arteriosclerosis|Elevated Cholesterol|Familial Hypercholesterolemia","interventions":[{"intervention_type":"Drug","name":"Drug: lerodalcibep","description":"PCSK9 inhibitor"}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of Treatment-Emergent Adverse Events as assessed by Medical Dictionary for Regulatory Activities as severe, moderate or mild after 48 and 72 weeks","time_frame":"72 weeks","description":"Evaluation of Adverse Events based on MedRA based on ITT population"},{"outcome_type":"secondary","measure":"Immunogenicity","time_frame":"72 weeks","description":"Incidence of anti-drug antibodies"},{"outcome_type":"secondary","measure":"LDL Cholesterol reduction","time_frame":"72 weeks","description":"Percent decrease in LDL-C from baseline of original study"}]}
{"nct_id":"NCT04478682","start_date":"2020-12-01","phase":"N/A","enrollment":140,"brief_title":"Breastfeeding Support Provided to Mothers Through WhatsApp Messaging Application","official_title":"The Effect of Continuous Breastfeeding Support Provided to Mothers Through WhatsApp Messaging Application on Breastfeeding: A Randomized Controlled Trial","primary_completion_date":"2021-06-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-09-01","last_update":"2021-03-22","description":"The research was planned as a randomized controlled experimental study in order to determine the effect of continuous breastfeeding support provided to mothers through WhatsApp messaging application on breastfeeding. Research Hypotheses H0: Continuous breastfeeding support provided to mothers through WhatsApp messaging application has no effect on breastfeeding. H1: Continuous breastfeeding support provided to mothers through WhatsApp messaging application increases the rate of exclusive breastfeeding. H2: Continuous breastfeeding support provided to mothers through WhatsApp messaging application increases the breastfeeding duration of the mothers. H3: Continuous breastfeeding support provided to mothers through WhatsApp messaging application reduces the rate of mothers giving their babies other foods than breast milk. H4: Continuous breastfeeding support provided to mothers through WhatsApp messaging application reduces bottle feeding rates. H5: Continuous breastfeeding support provided to mothers through WhatsApp messaging application reduces the rate of pacifier use. H6: Continuous breastfeeding support provided to mothers through WhatsApp messaging application reduces the incidence of mothers' breastfeeding problems. H7: Continuous breastfeeding support provided to mothers through WhatsApp messaging application affects mothers' breastfeeding attitude positively. H8: Continuous breastfeeding support provided to mothers through WhatsApp messaging application increases the motivation of breastfeeding mothers.","other_id":"AhiEvranU","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","intervention_model_description":"Randomized Controlled Study","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":49,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        For the mother;\r\n\r\n          -  18 years and older\r\n\r\n          -  Primipar,\r\n\r\n          -  Having healthy pregnancy and uncomplicated birth,\r\n\r\n          -  No health problems preventing breastfeeding (drug use, HIV, etc.),\r\n\r\n          -  Not having any obstacle to communication (not knowing Turkish, mental retardation\r\n             etc.),\r\n\r\n          -  Being literate,\r\n\r\n          -  Having a smart phone and internet connection,\r\n\r\n          -  It was determined to be able to use WhatsApp application. For baby;\r\n\r\n          -  Being healthy and term\r\n\r\n          -  No health problems preventing breastfeeding (Esophageal atresia, cleft palate, cleft\r\n             lip etc.)\r\n\r\n          -  Its weight is between 2500-4000 gr.\r\n\r\n          -  It was determined that the Apgar Score was above 7.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Mothers with multiple pregnancies,\r\n\r\n          -  Infants lying in NICU due to health problems in the postpartum period will be excluded\r\n             from the scope of the research.\r\n      ","sponsor":"Ahi Evran University Education and Research Hospital","sponsor_type":"Other","conditions":"Exclusive Breastfeeding|Breastfeeding Support","interventions":[{"intervention_type":"Other","name":"Other: Breastfeeding Support Provided to Mothers Through WhatsApp Messaging Application","description":"Breastfeeding support provided to mothers through WhatsApp messaging application will be maintained for the first 6 months after birth. In the first 1 month, standard information sharing will be made through whatsApp. Also, for the first 6 months, solutions generating shares will be made according to the problems and questions of the mother regarding breastfeeding."}],"outcomes":[{"outcome_type":"primary","measure":"Breastfeeding Attitudes of The Evaluation Scale","time_frame":"In our study, will be applied before breastfeeding education in hospital and through online survey at postpartum 6th months for both groups","description":"This scale assesses various aspects of attitudes that direct mothers' breastfeeding behavior. Examines breastfeeding as behavior.\r\nThe scale is a five-point Likert type consisting of 46 items, easy to apply, and which people can answer on their own, and it can be applied to all mothers. Some items in the scale (3, 4, 6, 7, 8, 11, 13, 15, 19, 23, 24, 26, 27, 28, 29, 30, 31, 32, 37, 38, 42, 43) As a positive attitude, I agree with the statement \"I totally disagree\" to 4-3-2-1-0, while some items (1, 2, 5, 9, 10, 12, 14, 16, 17, 18, 20, 21 (22, 25, 33, 34, 35, 36, 39, 40, 41, 44, 45, 46) are considered negative, and the opposite score is scored as 0-1-2-3-4 from the statement entirely agree. In this way, the total score that can be obtained from the scale is between 0 and 184. As the score increases, breastfeeding attitude is evaluated as positive."},{"outcome_type":"primary","measure":"Primipara Breastfeeding Motivation Scale (PBMS)","time_frame":"at postpartum 6th months through online survey for both groups","description":"This scale evaluates postpartum breastfeeding motivation level in primiparous. The scale consists of 24 items in total. After applying to the sample group, the factor analysis of the scale was made and it was determined to have 5 factors.\r\nIntrinsic motivation and integrated regulation\r\nIdentified regulation\r\nMirrored editing\r\nExternal regulation is examined in two sub-dimensions:\r\nExternal regulation (instrumental needs)\r\nExternal regulation (baby health) Scale items are rated from 1 = Never disagree to 4 = Strongly agree. The scale is in 4-point Likert type, and each item is scored between 1-4. The scale does not have a total score. The score of the sub-dimensions is calculated by taking the average of the scale sub-dimension scores. As the score obtained from the sub-dimension of the scale increases, the motivation representing that sub-dimension increases."},{"outcome_type":"primary","measure":"Application Satisfaction Evaluation Form","time_frame":"at postpartum 6th months through online survey for only experimental group","description":"Evaluates the satisfaction of mothers from breastfeeding support provided through WhatsApp messaging application.\r\nIt is a form consisting of 10 questions by the researcher to evaluate the satisfaction of the mothers from the breastfeeding support given through the social media group (WhatsApp) by making use of the literature information.\r\nThe answer to each question will be evaluated as yes / no. In the tenth question, he will be asked to score the application. There will be a minimum of 1 and a maximum of 10 points."}]}
{"nct_id":"NCT04700059","start_date":"2020-12-01","phase":"N/A","enrollment":300,"brief_title":"Family Intervention to Improve Maternal and Child Mental Health","official_title":"Adaptation and Assessment of a Family Intervention Designed to Improve Maternal and Child Mental Health in a Resource-limited Setting","primary_completion_date":"2022-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-12-31","last_update":"2021-01-07","description":"This pilot study will assess the acceptability, feasibility and efficacy of a family-based intervention to improve maternal and child mental health by increasing maternal sensitivity and decreasing offspring abuse among adolescent mothers in Per, a middle-income country with high rates of childhood physical and sexual abuse, IPV, and adolescent pregnancy.","other_id":"IRB18-0533","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":14,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  All subjects must be able to read and write Spanish.\r\n\r\n          -  RCT will be limited to pregnant adolescents who are between the ages of 14-19 years\r\n             and 12-34 weeks gestational age. Other caregivers (age 14 years or older) will be\r\n             eligible if they are planning to be involved in infant care.\r\n\r\n          -  Only pregnant adolescents receiving outpatient prenatal care at INMP or San Bartolom\r\n             will be approached as potential participants.\r\n\r\n          -  Only pregnant adolescents who have been cleared by their attending doctor/nurse to\r\n             engage in the approach/recruitment and interview procedure will be approached as\r\n             potential participants.\r\n\r\n          -  All infants born to adolescents enrolled during pregnancy will be eligible to be\r\n             enrolled after birth.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Anyone unable to read and write Spanish.\r\n\r\n          -  Any pregnant adolescent known to have a severe fetal anomaly will not be approached.\r\n\r\n          -  Infants who are advised not to participate by their attending doctor or pediatrician.\r\n\r\n          -  Children or adolescents who are wards of the state will not be enrolled.\r\n      ","sponsor":"Massachusetts General Hospital","sponsor_type":"Other","conditions":"Adolescent Pregnancy","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Virtual perinatal home visiting","description":"10 perinatal home visits"}],"outcomes":[{"outcome_type":"primary","measure":"Emotional availability scales","time_frame":"6 months after birth","description":"Video recorded coded assessment of caregiver and infant interaction"},{"outcome_type":"primary","measure":"Still face paradigm","time_frame":"6 months after birth","description":"Assessment of infant emotion regulation in response to stress"},{"outcome_type":"secondary","measure":"PHQ-9","time_frame":"At enrollment and 6 months after birth","description":"Maternal depression"},{"outcome_type":"secondary","measure":"GAD-7","time_frame":"At enrollment and 6 months after birth","description":"Maternal anxiety"},{"outcome_type":"secondary","measure":"PCL-C","time_frame":"At enrollment and 6 months after birth","description":"Maternal PTSD"}]}
{"nct_id":"NCT04240600","start_date":"2020-12-01","phase":"N/A","enrollment":74,"brief_title":"Effect of a Hyperproteic Hyperenergetic Enteral Formula on Body Composition and VEGF in AML During Hospital Stay","official_title":"Effect of a Hyperproteic Hyperenergetic Enteral Formula on Body Composition, Muscle Strength and Concentration of Vascular Endothelial Growth Factor (VEGF) in Patients With Actue Myeloid Leukemia (AML) During the Hospital Stay","primary_completion_date":"2021-01-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-12-01","last_update":"2020-09-03","description":"A randomized controlled clinical trial in two groups of supplementation with high protein enteral formula and a normocaloric enteral formula in two groups of 37 patients .","other_id":"DI/19/11/03/017","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","intervention_model_description":"A randomized clinical trial study","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adult patients with a confirmed diagnosis of AML\r\n\r\n          -  Tolerance to oral feeding\r\n\r\n          -  Induction Chemotherapy\r\n\r\n          -  Patients with nutritional risk of positive malnutrition (Score +3 NRS).\r\n\r\n          -  Candidates to receive enteral nutrition, as well as chemotherapy according to medical\r\n             indications.\r\n\r\n          -  Life expectancy greater than a week and with the possibility of starting oncological\r\n             treatment. Have informed consent obtained by the patient prior to randomization\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Geriatric patients (> 60 years)\r\n\r\n          -  Patients with acute gastrointestinal bleeding, ileus and shock\r\n\r\n          -  History of recurrence of neoplasm\r\n\r\n          -  Renal failure\r\n\r\n          -  Atrophy of the gastrointestinal mucosa\r\n\r\n          -  Central nervous system disease,\r\n\r\n          -  impaired cardiac function.\r\n\r\n        Elimination criteria:\r\n\r\n        Lack of follow up Incomplete data. Insufficient amount of genetic material to perform the\r\n        determination of the VEGF material.\r\n\r\n        Absence of the determination of the levels of VEGF prior to the start of oncological\r\n        therapy.\r\n      ","sponsor":"Hospital General de Mexico","sponsor_type":"Other","conditions":"Acute Myeloid Leukemia, Adult","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Experimental group","description":"2 cans or bottles (200ml)per day, orally"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Control group","description":"2 cans or bottles (200ml)per day, orally"}],"outcomes":[{"outcome_type":"secondary","measure":"Body composition fat mass","time_frame":"21 days","description":"To messured fat mass with seca mBCA 525medical Body Composition Analyzer at the beginning and after intervention therapy."},{"outcome_type":"secondary","measure":"Body compositition: fat-free mass","time_frame":"21 days","description":"To messured fat-free mass with seca mBCA 525medical Body Composition Analyzer at the beginning and after intervention therapy."},{"outcome_type":"secondary","measure":"Body composition: phase angle","time_frame":"21 days","description":"To messured phase angle with seca mBCA 525medical Body Composition Analyzer at the beginning and after intervention therapy."},{"outcome_type":"secondary","measure":"SARC-F","time_frame":"21 days","description":"To evaluate the score of SARC-F (an scale of symptoms to predict patients with sarcopenia at risk of low functional outcome) at the beginning and after intervention therapy."},{"outcome_type":"secondary","measure":"Length of stay","time_frame":"It depends of the patients health condition","description":"To evaluate the length of stay (in days) of their induction chemotherapy recovery"},{"outcome_type":"primary","measure":"Effect of use of hyperproteic, hypercaloric enteral formula in body composition and VEGF","time_frame":"21 days","description":"The aim of this study is to compare the effect of the use of a hyperproteic hypercaloric enteral formula (Supportan DKN.) With a standard enteral formula (Fresubin® Original DRINK) in patients with AML during antineoplastic treatment."},{"outcome_type":"secondary","measure":"Early mortality","time_frame":"21 days","description":"Estimation of early mortality (first three weeks) in patients receiving chemotherapy treatment"},{"outcome_type":"secondary","measure":"Late mortality","time_frame":"1 year","description":"Estimation of late mortality (one-year follow-up) in patients receiving chemotherapy"},{"outcome_type":"secondary","measure":"Changes in nutritional status during oncological therapy","time_frame":"21 days","description":"To documented in text format presence of changes in nutritional status according biochemical,clinical and anthropometric paramethers . This changes will be evaluated by a standarized nutricionist acording ESPEN guideliness for oncological patients"},{"outcome_type":"secondary","measure":"Evaluation of the quality of life at the beginning and after the intervention.","time_frame":"21 days","description":"To evaluate the score of the European Organization for Research and Treatment of Cancer (EORTC) at the beginning and after intervention therapy."},{"outcome_type":"secondary","measure":"Levels of VEGF","time_frame":"2 years","description":"To determinate cuantitative levels of VEGF´s RNA expression at the beginning and after treatment"},{"outcome_type":"secondary","measure":"Response to induction chemotherapy.","time_frame":"28 days","description":"To evaluate response to induction chemotherapy from to blast citometry percentaje"},{"outcome_type":"secondary","measure":"Early biochemical recovery values","time_frame":"28 days","description":"To evaluate the recovery of platelets, neutrophils, hemoglobin"}]}
{"nct_id":"NCT04656834","start_date":"2020-11-30","enrollment":80,"brief_title":"Hand Incision Study","official_title":"Hand Surgical Incision Outcomes","primary_completion_date":"2021-11-30","study_type":"Observational","rec_status":"Enrolling by invitation","completion_date":"2021-11-30","last_update":"2020-12-07","description":"The cosmetic outcome of a patient's surgical scar is important for patient satisfaction, especially in more visibly exposed areas of the body such as the hand. A patient's surgical scar often serves as a long-term reminder of their surgery experience, so optimizing final scar appearance should be of high importance. Surgical incision closure techniques and suture materials may vary by individual hand surgeons, even with common hand procedures.","other_id":"AILY20D.947","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Participants who are 18 years old or older who are having surgery for either a trigger\r\n        finger release or carpal tunnel release by one of Rothman Orthopaedics Hand & Wrist\r\n        Surgeons","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients  18 years old\r\n\r\n          -  Able to provide consent\r\n\r\n          -  Undergoing either trigger finger release or carpal tunnel release\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients < 18 years old\r\n\r\n          -  Unable to provide consent\r\n\r\n          -  Unable to comply with follow up requirements\r\n      ","sponsor":"Rothman Institute Orthopaedics","sponsor_type":"Other","conditions":"Hand Surgery","interventions":[{"intervention_type":"Procedure","name":"Procedure: hand incision closure using monocryl sutures and skin glue","description":"At the end of surgery, the investigator will close the incision using monocryl sutures and skin glue"},{"intervention_type":"Procedure","name":"Procedure: hand incision closure using simple nylon sutures","description":"At the end of surgery, the investigator will close the incision using simple nylon sutures"}],"outcomes":[{"outcome_type":"primary","measure":"Participant Satisfaction with Scar Appearance (Questionnaire #1)","time_frame":"12 weeks","description":"Participant will be asked to answer a series of questions regarding the cosmetic appearance of their surgical scar and how satisfied they are with the appearance of the scar as measured by the Patient Scar Assessment Questionnaire (PSAQ)."},{"outcome_type":"primary","measure":"Participant Satisfaction with Scar Appearance (Questionnaire #2)","time_frame":"12 weeks","description":"Participant will be asked to answer a series of questions regarding the cosmetic appearance of their surgical scar and how satisfied they are with the appearance of the scar as measured by the Stony Brook Scar Evaluation Scale (SBSES)"},{"outcome_type":"primary","measure":"Participant Satisfaction with Scar Appearance (Questionnaire #3)","time_frame":"12 weeks","description":"Participant will be asked to answer a series of questions regarding the cosmetic appearance of their surgical scar and how satisfied they are with the appearance of the scar as measured by the Visual Analog Scale (VAS)"}]}
{"nct_id":"NCT04203992","start_date":"2020-11-30","phase":"N/A","enrollment":284,"brief_title":"Videogame for the Prevention of Doping and Supplement Abuse in Teenage Athletes","official_title":"TRUE CHAMPION: An Educational Videogame Intervention for the Prevention of Doping and Supplement Abuse in Teenage Athletes","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2022-06-30","last_update":"2020-09-16","description":"The purpose of this research is to test the effectiveness of an interactive doping education videogame among student athletes. Specifically, the game will teach athletes aged 13-16 years about the risks of doping and will foster the values, motivation, and behavioural skills needed to avoid temptation and pressure to dope. The investigators hypothesize that student athletes who play the intervention game will have lower use of banned substances and sport supplements, greater intentions to stay clean, and will also show improvements in the cognitive and motivational antecedents to doping when compared to a control condition.","other_id":"476-0418","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","intervention_model_description":"We aim to enroll 284 male and female student-athletes between the ages of 13 and 16. Participants will be assigned to either an intervention group (n = 142) or a comparison group (n = 142).","sampling_method":"","gender":"All","minimum_age":13,"maximum_age":16,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subject competes in a competitive sport at the high school level or higher\r\n\r\n          -  Able to read and understand English\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  None\r\n      ","sponsor":"McGill University","sponsor_type":"Other","conditions":"Doping in Sport|Performance Enhancing Product Use","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Videogame","description":"True Champion is an educational, values-based game that aims to empower young athletes to make informed decisions to avoid doping.\r\nParticipants engaging in the videogame sessions will encounter a series of thought-provoking situations and knowledge tests. Players will help their assigned character navigate through these curriculum-rich scenarios in order to reach their performance goals in a healthy and ethical way."},{"intervention_type":"Behavioral","name":"Behavioral: Control","description":"Participants will be given an anti-doping booklet prepared by UNESCO. This booklet is considered standard educational material, i.e. what might be presented to young athletes as part of their regular sports curriculum."}],"outcomes":[{"outcome_type":"secondary","measure":"Knowledge","time_frame":"12 months","description":"Knowledge of anti-doping rules, definitions and consequences of doping.\r\nThis outcome will be assessed using a True/False questionnaire."},{"outcome_type":"primary","measure":"Intentions to use banned substances and sport supplements","time_frame":"12 months","description":"Self-reported intentions of using banned substances or supplements for performance enhancement or recovery in sport.\r\nThis outcome will be measured using a self-reported questionnaire.\r\nScale: Performance-Enhancing Substances and Methods Use\r\nMinimum value: 1 - extremely unlikely (better outcome)\r\nMaximum value: 7 - extremely likely (worse outcome)"},{"outcome_type":"secondary","measure":"Doping Self-Regulatory Efficacy","time_frame":"12 months","description":"Self-efficacy for refusing doping under a variety of pressure situations.\r\nThis outcome will be measured using a validated questionnaire.\r\nScale: Doping Self-Regulatory Efficacy\r\nMinimum value: 1 - no confidence (better outcome)\r\nMaximum value: 5 - complete confidence (worse outcome)"},{"outcome_type":"primary","measure":"Use of banned substances","time_frame":"12 months","description":"Self-reported use of banned substances for performance enhancement or recovery in sport.\r\nThis outcome will be measured using a self-reported questionnaire.\r\nScale: Performance-Enhancing Substances and Methods Use\r\nMinimum value: 1 - extremely unlikely (better outcome)\r\nMaximum value: 7 - extremely likely (worse outcome)"},{"outcome_type":"primary","measure":"Use of sport supplements","time_frame":"12 months","description":"Self-reported use of supplements for performance enhancement or recovery in sport.\r\nThis outcome will be measured using a self-reported questionnaire.\r\nScale: Performance-Enhancing Substances and Methods Use\r\nMinimum value: 1 - extremely unlikely (better outcome)\r\nMaximum value: 7 - extremely likely (worse outcome)"},{"outcome_type":"secondary","measure":"Motivation","time_frame":"12 months","description":"Motivations for abstaining from doping.\r\nThis outcome will be measured using an adaptation of a validated questionnaire.\r\nScale: Treatment Self-Regulation Questionnaire for the Avoidance of Doping in Sport\r\nMinimum value: 1 - not true at all (worse outcome)\r\nMaximum value: 7 - very true (better outcome)"},{"outcome_type":"secondary","measure":"Attitudes","time_frame":"12 months","description":"Attitudes towards doping in sport.\r\nThis outcome will be measured using a subscale from a validated questionnaire.\r\nScale: The Adolescent Sport Doping Inventory\r\nMinimum value: 1 - strongly disagree (worse outcome)\r\nMaximum value: 7 - strongly agree (better outcome)\r\nNote: some items are reverse-scored"},{"outcome_type":"secondary","measure":"Anti-doping protective behaviours","time_frame":"12 months","description":"Self-reported engagement in behaviours linked to doping abstinence.\r\nScale: Microbehaviours\r\nMinimum value: 1 - never (worse outcome)\r\nMaximum value: 7 - always (better outcome)"},{"outcome_type":"secondary","measure":"Doping refusal","time_frame":"12 months","description":"Self-report of having refused a supplement or performance-enhancing substance.\r\nThis outcome will be assessed using a Yes (worse outcome) or No (better outcome) questionnaire."},{"outcome_type":"secondary","measure":"Gameplay experience","time_frame":"1 month","description":"Enjoyment and acceptability of the True Champion videogame among players assigned to the intervention condition.\r\nThis outcome will be assessed using a questionnaire we have created. Answers will range from \"strongly disagree\" to \"strongly agree\"."}]}
{"nct_id":"NCT04401631","start_date":"2020-11-30","enrollment":0,"brief_title":"Analytical Validation of the abioSCOPE Device With an IgE Test Panel: Point-of-Care Precision, Sample Type Comparison and Method Correlation","official_title":"Analytical Validation of the abioSCOPE Device With an IgE Test Panel: Point-of-Care Precision, Sample Type Comparison and Method Correlation","primary_completion_date":"2020-11-30","study_type":"Observational","rec_status":"Withdrawn","completion_date":"2020-12-31","last_update":"2020-10-05","description":"This is a multicenter, prospective, observational study to evaluate the analytical performance of the Abionic IgE Multi-Allergen Test Panel on the abioSCOPE device in a U.S. point-of-care environment within a clinical laboratory operating under a CLIA certificate for tests of moderate complexity. The study will assess point-of-care ('external') precision, sample type comparison and correlation with a reference method (Phadia Laboratory System, ThermoFisher Scientific).","other_id":"AB-ALL-3.1","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"-  A minimum of 20 subjects with targeted levels of total IgE are needed to participate\r\n             in the Operator-to-Operator whole blood study.\r\n\r\n          -  A minimum of 20 subjects with targeted levels of allergen-specific and total IgE are\r\n             needed to participate in the capillary whole blood between-run imprecision study in\r\n             the POL environment.\r\n\r\n          -  A minimum of 40 subjects with targeted levels of Fel d 1-specific IgE and total IgE\r\n             are needed to participate in the sample type comparison study. These subjects will be\r\n             recruited, and their samples analyzed at 1 POL.\r\n\r\n          -  A minimum of 300 subjects (approximately 100 subjects enrolled and evaluated at each\r\n             of three sites) and with targeted levels of total IgE are needed to participate in the\r\n             method comparison study.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Provision and understanding of signed and dated written informed consent by the\r\n             subject prior to any mandatory study-specific procedures, sample collection, or\r\n             analysis.\r\n\r\n          -  Male or female, 18 years of age or older.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subject participating in another study that may influence test results.\r\n\r\n          -  Subject taking any of the following medications: systemic steroids (inhaled or nasal\r\n             steroids are allowed), anti-cytokines or cytokines, systemic interferon (injection\r\n             local interferon  for the treatment of HPV is allowed), anti-IgE therapy (approved or\r\n             investigational) or treated with systemic chemotherapy.\r\n\r\n          -  History of cancer, autoimmune, or immune deficiency disease.\r\n\r\n          -  Suffering from a hematological pathology (coagulation disorder, severe anemia) that\r\n             could interfere with the blood draw procedure.\r\n      ","sponsor":"Abionic SA","sponsor_type":"Industry","conditions":"Allergy|Allergic Asthma|Allergy to Cats|Allergy to House Dust|Allergy to Dog Dander (Finding)|Allergy Mold|Allergy Cockroach","interventions":[{"intervention_type":"Device","name":"Device: Blood Collection","description":"Between-Run Reproducibility K3-EDTA venous whole blood 3 mL 1 venous draw\r\nOperator-to-operator imprecision (abioSCOPE) K3-EDTA capillary whole blood 0.05 mL/draw; 0.15 mL total 3 finger sticks (3 different fingers)\r\nSample type comparison (abioSCOPE) K3-EDTA capillary whole blood, venous serum, venous K3-EDTA plasma 0.35 mL (finger stick), 9 mL of whole blood to get a minimum of 3 mL of serum and 9 mL of whole blood K3-EDTA to get a minimum of 3 mL of plasma 1 finger stick; 1 venous draw into serum tube (9 mL) and 1 venous draw into K3-EDTA plasma tube (9 mL), in total 18 mL\r\nMethod comparison (abioSCOPE and ImmunoCAP/Phadia) K3-EDTA capillary whole blood, venous K3-EDTA plasma 0.05 mL (finger stick), 9 mL of whole blood to get a minimum of 3 ml of plasma 1 finger stick; 1 venous draw into K3-EDTA plasma tube (9 mL tube)"}],"outcomes":[{"outcome_type":"primary","measure":"POC variance components (in a POL environment):","time_frame":"Day 1","description":"External Precision Study ('reproducibility study' 'site-to-site precision study'): Demonstrate that the imprecision of K3-EDTA venous plasma using the IVD CAPSULE Allergic Asthma panel on the abioSCOPE device (all 5 allergens/allergen mixes and total IgE) in the hands of trained Healthcare Professionals in a Physician Office Laboratory (POL) is within the expected range of the imprecision established in the clinical laboratory by Laboratory Scientists.\r\nOperator-to-Operator imprecision on whole blood: Demonstrate that the between-Operator reproducibility of the total IgE of the IVD CAPSULE Allergic Asthma panel on the abioSCOPE device test results is within the expected range of variability.\r\nBetween-run reproducibility: Demonstrate that the between-run reproducibility of venous whole blood samples measured with the IVD CAPSULE Allergic Asthma panel on the abioSCOPE device (all 5 allergens/allergen mixes and total IgE) is within the expected range of variability."},{"outcome_type":"primary","measure":"Sample type comparison:","time_frame":"Day 1","description":"Demonstrate that the IVD CAPSULE Allergic Asthma panel on the abioSCOPE device test results obtained from capillary whole blood correlates well with values obtained from K3-EDTA anticoagulated venous plasma and serum samples."},{"outcome_type":"primary","measure":"Method comparison","time_frame":"Day 1","description":"Demonstrate that test results obtained with the total IgE test of the IVD CAPSULE Allergic Asthma panel on the abioSCOPE device correlates with total IgE test results from the reference method (Phadia Laboratory System, ThermoFisher Scientific)."}]}
{"nct_id":"NCT04565964","start_date":"2020-11-25","phase":"N/A","enrollment":80,"brief_title":"Association Between Household Health Behaviors and Asthma in Children","official_title":"Association Between Household Health Behaviors and Asthma in Children","primary_completion_date":"2020-12-29","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-08-31","last_update":"2020-12-01","description":"This study plan to study the association between household health behavior (cleaning habits) and children's asthma. In addition, reconfirm the health effects of indoor environmental exposure to phthalates plasticizers, mite, fungi, and bacteria, and cockroaches on children's asthma. Thus, the investigators can provide a non-pharmacological intervention to reduce the disease burden of children's asthma and allergic diseases.","other_id":"202006172RIND","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":7,"maximum_age":12,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  aged 7-12 years-old who have physician-diagnosed asthma\r\n\r\n          -  stable patient\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  acute allergies\r\n\r\n          -  severe brain and heart disease\r\n\r\n          -  mental illness\r\n      ","sponsor":"National Taiwan University Hospital","sponsor_type":"Other","conditions":"Asthma in Children","interventions":[{"intervention_type":"Other","name":"Other: change the health behaviors to clean indoor environment","description":"Sheets and all covers should be wash weekly. Clean indoor environment with a vacuum cleaner twice a week"}],"outcomes":[{"outcome_type":"primary","measure":"Peak expiratory flow changes","time_frame":"one month","description":"Using peak flow meter to monitor the participant's peak expiratory flow values in the morning and evening to effectively evaluate subject's asthma status."},{"outcome_type":"primary","measure":"fractional concentration of exhaled nitric oxide","time_frame":"one month","description":"Before and after the intervention, test for the levels of fractional exhaled nitric oxide in the hospital to evaluate the condition of airway inflammation."},{"outcome_type":"primary","measure":"Pulmonary function test (FVC)","time_frame":"one month","description":"Before and after the intervention, test for the volumes of the forced vital capacity (FVC) in the hospital as an indicator of asthma status."},{"outcome_type":"primary","measure":"Pulmonary function test (FEV1)","time_frame":"one month","description":"Before and after the intervention, test for the volumes of the forced expiratory volume in one second (FEV1) in the hospital as an indicator of asthma status."},{"outcome_type":"primary","measure":"Pulmonary function test (FEV1/FVC ratio)","time_frame":"one month","description":"Before and after the intervention, test for the FEV1/FVC ratio in the hospital as an indicator of asthma status."},{"outcome_type":"primary","measure":"Symptomatology (cough)","time_frame":"one month","description":"Asthma symptom is recorded daily by caregivers."},{"outcome_type":"primary","measure":"Symptomatology (wheezing)","time_frame":"one month","description":"Asthma symptom is recorded daily by caregivers."},{"outcome_type":"primary","measure":"Symptomatology (chest tightness)","time_frame":"one month","description":"Asthma symptom is recorded daily by caregivers."},{"outcome_type":"primary","measure":"dust mites allergen concentrations","time_frame":"one month","description":"Before and after the intervention, allergen concentrations will be sampled in a fixed area in the subject's bedroom, and dust mites' antibody will be analyzed in the laboratory."},{"outcome_type":"primary","measure":"phthalates concentrations","time_frame":"one month","description":"Sampling in a fixed area in the subject's bedroom, and phthalates concentration will be analyzed in the laboratory."},{"outcome_type":"primary","measure":"cockroach numbers","time_frame":"one month","description":"Before and after the intervention, count the numbers of cockroach will be sampled for every week, in a fixed area in the subject's bedroom."}]}
{"nct_id":"NCT04772703","start_date":"2020-11-23","enrollment":10,"brief_title":"DNA Damage in Critically Ill COVID-19 Patients","official_title":"DNA Damage in Critically Ill Patients With SARS-CoV-2 Infection With Organ Failure","primary_completion_date":"2021-02-28","study_type":"Observational","rec_status":"Recruiting","completion_date":"2021-07-30","last_update":"2021-02-26","description":"Critically ill patients with COVID-19 are exposed to high oxidative stress which is potential harm to the DNA. Peripheral lymphocytes' DNA will be investigated using the comet assay on changes in oxidative damage to the purine and pyrimidine bases and single-stranded DNA breaks.","other_id":"CVV_COVID-19_DNA","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Critically ill patients admitted to ICU with signs and symptoms of organ failure, mainly\r\n        respiratory failure. Need for means of respiratory and/or circulatory support. A positive\r\n        test of COVID-19: RT-PCR test or bed-side antigen test.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  critically ill adult patient admitted to ICU with positive RT-PCR test or bed-side\r\n             antigen test on COVID-19 with signs and symptoms of organ failure\r\n\r\n          -  informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  rejection by the patient to sign an informed consent\r\n      ","sponsor":"University Hospital Hradec Kralove","sponsor_type":"Other","conditions":"Covid19|Organ Failure, Multiple|DNA Damage","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: COMET ASSAY","description":"The description in the detailed description of the study"}],"outcomes":[{"outcome_type":"primary","measure":"single-stranded DNA breaks","time_frame":"One week","description":"Changes in the single-stranded DNA breaks in peripheral lymphocytes"},{"outcome_type":"primary","measure":"oxidation of DNA bases","time_frame":"One week","description":"Changes in oxidised purine and pyrimidine bases of peripheral lymphocytes DNA"},{"outcome_type":"secondary","measure":"Mortality","time_frame":"One month","description":"All cause 30-day mortality"}]}
{"nct_id":"NCT04567498","start_date":"2020-11-20","phase":"N/A","enrollment":1778,"brief_title":"eNose-TB: Electronic Nose for Tuberculosis Screening","official_title":"eNose-TB: Electronic Nose for Tuberculosis Screening in Indonesia","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2021-12-31","last_update":"2020-11-23","description":"An electronic-nose (e-nose) had been investigated as a diagnostic tool for tuberculosis by examining exhaled breath of the patients. Universitas Gadjah Mada has developed an e-nose device for TB diagnostic tool. Here the investigators test the device in order to analyze the sensitivity and specificity electronic-nose as a screening tool for tuberculosis.","other_id":"002/2019","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Screening","masking_description":"Triple","intervention_model_description":"The Validation phase involves suspected TB patients (Group 1) and the Screening phase involves residents of area with high risk of TB (Group 2)","sampling_method":"","gender":"All","minimum_age":4,"population":"","criteria":"\n        - Inclusion Criteria:\r\n\r\n        Validation Phase (Group 1):\r\n\r\n          -  Adult and children\r\n\r\n          -  Suspected of having TB\r\n\r\n          -  Agree to participate in the study\r\n\r\n          -  Able to produce exhaled air samples\r\n\r\n          -  Able to produce samples for Xpert MTB/Rif examination\r\n\r\n        Screening Phase (Group 2):\r\n\r\n          -  Adult and children\r\n\r\n          -  Agree to participate in the study\r\n\r\n          -  Able to produce exhaled air samples\r\n\r\n          -  Currently not in TB treatment\r\n\r\n             - Exclusion Criteria\r\n\r\n          -  Invalid measurements of breath tests\r\n\r\n          -  Incomplete CXR data\r\n\r\n          -  Missing specimens\r\n\r\n          -  Unable to breath normally for 2 minutes due to respiratory illness\r\n      ","sponsor":"Gadjah Mada University","sponsor_type":"Other","conditions":"Tuberculosis","interventions":[{"intervention_type":"Other","name":"Other: exhaled breath sampling","description":"The participants are requested to quietly sit and breathe to the air collecting bag until the collecting bag is full. The collecting bag is sealed and connected to the e-nose machine via a collecting hose and HEPA-filter. The data are read and stored in the e-nose machine."},{"intervention_type":"Other","name":"Other: exhaled breath sampling","description":"The participants are requested to quietly sit and breathe to the air collecting bag until the collecting bag is full. The collecting bag is sealed and connected to the e-nose machine via a collecting hose and HEPA-filter. The data are read and stored in the e-nose machine."}],"outcomes":[{"outcome_type":"primary","measure":"diagnostic accuracy of electronic nose signal in tuberculosis","time_frame":"2 years","description":"sensitivity, specificity, positive predictive value, negative predictive value of e-nose signal in diagnosing TB"}]}
{"nct_id":"NCT04373083","start_date":"2020-11-15","phase":"Phase 2","enrollment":0,"brief_title":"Anti-PD-1 Antibody Treatment With Cemiplimab and Radiotherapy in Early-stage Classical Hodgkin Lymphoma","official_title":"Anti-PD-1 Antibody Treatment With Cemiplimab and Radiotherapy in Early-stage Favorable Classical Hodgkin Lymphoma (CARHL) - A Randomized Phase II Trial","primary_completion_date":"2022-12-20","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2025-02-20","last_update":"2021-01-15","description":"The primary objective is to estimate the efficacy of experimental treatment with the anti-PD-1 antibody cemiplimab (REGN2810) in combination with simultaneous or subsequent radiotherapy (RT) in early-stage favorable classical Hodgkin lymphoma (cHL). Secondary objectives are to assess the safety and feasibility of the 2 experimental strategies.","other_id":"R2810-ONC-1615","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Key Inclusion Criteria:\r\n\r\n          -  Histologically proven classical HL\r\n\r\n          -  First diagnosis, no previous treatment\r\n\r\n          -  Stage I-II without risk factors as defined in the protocol\r\n\r\n        Key Exclusion Criteria:\r\n\r\n          -  Composite lymphoma or nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL)\r\n\r\n          -  Prior malignancy within the previous 5 years (except for locally treatable cancers\r\n             that have been apparently cured by complete resection)\r\n\r\n          -  Prior chemotherapy or radiation therapy\r\n\r\n          -  Concurrent disease precluding protocol treatment as defined in the protocol\r\n\r\n          -  Pregnancy or breast-feeding\r\n\r\n          -  Non-compliance as defined in the protocol\r\n\r\n        Note: Other protocol-defined Inclusion/Exclusion criteria apply\r\n      ","sponsor":"Regeneron Pharmaceuticals","sponsor_type":"Industry","conditions":"Hodgkin Lymphoma","interventions":[{"intervention_type":"Drug","name":"Drug: Cemiplimab","description":"Administered in 3-week intervals"},{"intervention_type":"Radiation","name":"Radiation: Involved-site radiotherapy (IS-RT)","description":"Patients will receive IS-RT with a dose of 20 Gy. Involved-site radiotherapy will be carried out on the basis of 3D imaging as described in the protocol"}],"outcomes":[{"outcome_type":"primary","measure":"Progression-free survival (PFS) at 1 year","time_frame":"From randomization up to 1 year"},{"outcome_type":"secondary","measure":"PFS at 2 and 3 years","time_frame":"From randomization up to 3 years"},{"outcome_type":"secondary","measure":"Overall survival (OS) at 1, 2, and 3 years","time_frame":"From randomization up to 3 years"},{"outcome_type":"secondary","measure":"Incidence of acute toxicities","time_frame":"Up to 90 days after study treatment"},{"outcome_type":"secondary","measure":"Rate of patients with long-term fatigue using EORTC-QLQ-FA12","time_frame":"12-18 months after randomization","description":"European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ).\r\n-FA12 module complements the core EORTC QLQ-C30 questionnaire regarding fatigue. Each item can be scored in four dimension on a scale from 1 to 4 with higher scores indicating worse symptoms."},{"outcome_type":"secondary","measure":"Rate of patients with long-term fatigue using EORTC-QLQ-C30","time_frame":"12-18 months after randomization","description":"Scores range from 0 to 100. A high scale score represents a higher response level."},{"outcome_type":"secondary","measure":"Quality of life (QoL) using EORTC-QLQ-30","time_frame":"Up to 3 years","description":"Scores range from 0 to 100. A high scale score represents a higher response level."},{"outcome_type":"secondary","measure":"Rate of early discontinuation of study treatment","time_frame":"From first dose to up to 19 weeks"},{"outcome_type":"secondary","measure":"Frequency of lymphoma treatment administered in addition to study treatment","time_frame":"From randomization up to 3 years"},{"outcome_type":"secondary","measure":"Types of lymphoma treatment administered in addition to study treatment","time_frame":"From randomization up to 3 years"}]}
{"nct_id":"NCT04686760","start_date":"2020-11-15","phase":"N/A","enrollment":30,"brief_title":"Efficacy of Inhaled Nitroglycerin in Moderate to Critically Ill COVID-19 Patients","official_title":"Efficacy of Inhaled Nitroglycerin in Moderate to Severe Cases of COVID-19 Patients","primary_completion_date":"2021-11-15","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-11-15","last_update":"2021-05-24","description":"In current analysis moderate to severely ill Covid-19 infected patients will be nebulized with nitroglycerin, and they will be compared with the standard nebulization","other_id":"IRBEC/BIH/08-2020","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Diagnosed admitted cases of Covid-19 degree of illness should be moderate to severe both\r\n        male and female every age group\r\n\r\n        Exclusion Criteria:\r\n\r\n        allergic to nitroglycerin sudden drop in blood pressure not given consent\r\n      ","sponsor":"University of Lahore","sponsor_type":"Other","conditions":"Corona Virus Infection","interventions":[{"intervention_type":"Drug","name":"Drug: Nitroglycerin","description":"2 mg/ml solution of nitroglycerin used for nebulization four hourly"}],"outcomes":[{"outcome_type":"primary","measure":"ratio of partial pressure of oxygen in arterial blood to fraction of inhaled oxygen","time_frame":"5-7 days"},{"outcome_type":"primary","measure":"Oxygen demand","time_frame":"5-7 days"},{"outcome_type":"secondary","measure":"Duration of hospital stay","time_frame":"15 days"}]}
{"nct_id":"NCT04573036","start_date":"2020-11-12","phase":"Phase 1","enrollment":50,"brief_title":"A Trial of HRS4800 Tables in Healthy Male Subjects","official_title":"A Phase 1, Single Center, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and the Effect of Food on the Pharmacokinetics of HRS4800 in Healthy Male Subjects","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-12-31","last_update":"2021-07-30","description":"This is a single-site study to evaluate the safety, tolerability and pharmacokinetics (PK) of single dose administration of HRS4800, and the effect of food on the PK of HRS4800 in healthy male subjects.","other_id":"HRS4800-I-101-AUS","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Able to understand the purposes and risks of the trial and comply with all study\r\n             procedures before entering the trial, and provide signed informed consent.\r\n\r\n          -  Male aged between 18 years and 55 years at screening, inclusive.\r\n\r\n          -  Total body weight 50 kg at screening, and body mass index (BMI) between 18.0 and 32.0\r\n             kg/m2, inclusive.\r\n\r\n          -  Agree to practice true abstinence; be surgically sterilised (performed at least 6\r\n             months prior and documented to no longer produce sperm - verbal confirmation through\r\n             medical history review acceptable); or agree to use a condom if sexually active with a\r\n             female partner of childbearing potential for at least 3 months after dosing.\r\n\r\n          -  No clinically significant abnormalities in medical history, general physical\r\n             examination, vital signs, laboratory tests (hematology, urinalysis, blood chemistry,\r\n             coagulation function), and ECG, as determined by the investigator. Male aged between\r\n             18 years and 55 years at screening, inclusive.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of severe digestive system disease or having a digestive disease currently\r\n             within a month of screening or before first dosing, and may affect drug absorption or\r\n             have safety risks.\r\n\r\n          -  Severe infections, injuries or surgeries within 3 months of screening or before first\r\n             dosing, or plan to undergo any surgeries during the trial.\r\n\r\n          -  Use of any medicine affecting liver metabolism within 1 month of screening (see\r\n             Appendix 1); use of any prescription medications within 14 days or 5 half-lives prior\r\n             to dosing, use of any over-the-counter medicine or herbal products within 7 days prior\r\n             to dosing; intention to use any other medicine during the trial.\r\n\r\n          -  Whole blood donation or loss of more than 200 mL of blood within 1 month prior to\r\n             dosing; or blood donation or loss of more than 400 mL of blood within 3 months prior\r\n             to dosing; or plasma donation within 14 days prior to dosing; or received blood within\r\n             8 weeks prior to dosing.\r\n\r\n          -  History of allergy to the study drug or any component of it.\r\n\r\n          -  History of regular alcohol consumption in the past 1 month exceeding an average weekly\r\n             intake of 21 standard drinks: 1 drink=5 ounces [150 mL] of wine or 12 ounces [360 mL]\r\n             of beer or 1.5 ounces [45 mL] of hard liquor).\r\n\r\n          -  Subject has used more than 5 tobacco or nicotine-containing products per day in the 6\r\n             months prior to dosing and is unable to refrain from use of such products from at\r\n             least 48 hours prior to check-in through to the final study visit.\r\n\r\n          -  Treatment with an investigational drug within 30 days (or 5 half-lives, whichever is\r\n             longer) of dosing.\r\n\r\n          -  History of drug abuse within 2 years prior to screening.\r\n\r\n          -  Other conditions or laboratory abnormality that may increase the risk associated with\r\n             study participation or IP administration or interfere with the interpretation of study\r\n             results and, at the discretion of the investigator, makes the subject inappropriate\r\n             for entry into this study.\r\n      ","sponsor":"Atridia Pty Ltd.","sponsor_type":"Industry","conditions":"Pain","interventions":[{"intervention_type":"Drug","name":"Drug: HRS4800 tablets","description":"single oral administration"},{"intervention_type":"Drug","name":"Drug: Placebo tablets","description":"single oral administration"}],"outcomes":[{"outcome_type":"primary","measure":"Change in QT interval from baseline by ECG","time_frame":"8 days"},{"outcome_type":"primary","measure":"Change in corrected QT (QTc) interval from baseline by ECG","time_frame":"8 days"},{"outcome_type":"primary","measure":"Change in P-R interval from baseline by ECG","time_frame":"8 days"},{"outcome_type":"primary","measure":"Incidence of AEs","time_frame":"8 days"},{"outcome_type":"primary","measure":"Severity of AEs","time_frame":"8 days"},{"outcome_type":"primary","measure":"Change in diastolic blood pressure and systolic blood pressure from baseline","time_frame":"8 days"},{"outcome_type":"primary","measure":"Change in pulse rate from baseline","time_frame":"8 days"},{"outcome_type":"primary","measure":"Change in respiratory rate from baseline","time_frame":"8 days"}]}
{"nct_id":"NCT04408625","start_date":"2020-11-09","phase":"Phase 1/Phase 2","enrollment":15,"brief_title":"Phase 1/2 Clinical Trial of PR006 in Patients With Frontotemporal Dementia With Progranulin Mutations (FTD-GRN)","official_title":"A Phase 1/2 Ascending Dose Study to Evaluate the Safety and Effects on Progranulin Levels of PR006A in Patients With Fronto-Temporal Dementia With Progranulin Mutations (FTD-GRN)","primary_completion_date":"2027-09-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2027-09-30","last_update":"2021-08-19","description":"Study PRV-FTD101 is a Phase 1/2, multi-center, open-label ascending dose, first-in-human study that will evaluate the safety and effect of intra-cisternal PR006 administration on progranulin protein (PGRN) levels in patients with frontotemporal dementia with progranulin mutations (FTD-GRN). Three escalating dose (low dose, medium dose and high dose) cohorts are planned. The duration of the study is 5 years. During the first year, patients will be evaluated for the effect of PR006 on safety, tolerability, immunogenicity, biomarkers, and efficacy. Patients will follow up for an additional 4 years to monitor safety and changes on selected biomarkers and clinical outcomes.","other_id":"PRV-FTD101","allocation":"Non-Randomized","intervention_model":"Sequential Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":30,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Body weight range of 40 kg (88 lbs) to 110 kg (242 lb) and a BMI of 18 to 34 kg/m2.\r\n\r\n          -  Has symptomatic frontotemporal dementia (FTD) per investigator assessment.\r\n\r\n          -  Stable use of background medications at least 8 weeks prior to PR006A dosing.\r\n\r\n          -  Carrier of a pathogenic GRN (progranulin gene) mutation.\r\n\r\n          -  Negative screening test for Mycobacterium tuberculosis (MTB) or documented negative\r\n             MTB test within 1 year prior to screening.\r\n\r\n          -  Age- and gender-appropriate cancer screenings are up-to-date.\r\n\r\n          -  Patient and/or patient's legally authorized representative has the ability to\r\n             understand the purpose and risks of the study, and provide written informed consent\r\n             and authorization to use protected health information.\r\n\r\n          -  Patient has a reliable study partner/informant (e.g. family member, friend) willing\r\n             and able to participate in the study as a source of information on the patient's\r\n             health status and cognitive and functional abilities.\r\n\r\n          -  Patient is not dependent on a walker or wheelchair.\r\n\r\n          -  Patient is living in the community (i.e. not in nursing home); some levels of assisted\r\n             living may be permitted at the discretion of the investigator.\r\n\r\n          -  Pneumococcal pneumonia and shingles vaccines are required within 10 years of Screening\r\n             (allowed to be performed during Screening but must be given at least 4 weeks prior to\r\n             initiation of immunosuppressant regimen).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Diagnosis of a significant CNS (central nervous system) disease other than\r\n             frontotemporal dementia (FTD) that may cause FTD symptoms or confound study\r\n             objectives.\r\n\r\n          -  Brain or cervical magnetic resonance image (MRI)/MRA imaging showing clinically\r\n             significant abnormality considered to prevent intracisternal injection.\r\n\r\n          -  Hypersensitivity or contraindications to corticosteroid, rituximab, and/or sirolimus\r\n             use.\r\n\r\n          -  Clinical evidence of peripheral symmetric sensory polyneuropathy (stable sensory\r\n             mononeuropathies and radiculopathies are not exclusionary).\r\n\r\n          -  Concomitant disease or condition within 6 months of screening that could interfere\r\n             with, or treatment of which might interfere with, the conduct of the study or that\r\n             would, in the opinion of the investigator, pose an unacceptable safety risk to the\r\n             patient or interfere with the patient's ability to comply with study procedures\r\n\r\n          -  Clinically significant laboratory test result abnormalities assessed at screening.\r\n\r\n          -  Participation within 3 months prior to screening in another therapeutic\r\n             investigational drug or device study with purported disease-modifying effects on FTD,\r\n             unless it can be documented that the patient received placebo only.\r\n\r\n          -  Any type of prior gene or cell therapy.\r\n\r\n          -  Immunizations (live vaccines) in the 4 weeks prior to Screening. Pneumococcal vaccine\r\n             and/or shingles vaccine administration is allowed at least 4 weeks prior to initiation\r\n             of immunosuppressant regimen.\r\n\r\n          -  Use of blood thinners in the 2 weeks prior to screening, or anticipated use of blood\r\n             thinners during the study. Antiplatelet therapies may be acceptable as long as usage\r\n             can be halted 48 hours before study drug administration.\r\n\r\n          -  Contraindications or intolerance to imaging methods (MRA, MRI, CT) and intolerance to\r\n             contrast agents.\r\n\r\n          -  Contraindications to general anesthesia or deep sedation.\r\n\r\n        Other protocol-defined inclusion/exclusion criteria may apply\r\n      ","sponsor":"Prevail Therapeutics","sponsor_type":"Industry","conditions":"Frontotemporal Dementia","interventions":[{"intervention_type":"Drug","name":"Drug: Methylprednisolone","description":"1-2 IV pulses administered as concomitant medication"},{"intervention_type":"Drug","name":"Drug: Sirolimus","description":"Loading dose, followed by maintenance dose, followed by dose tapering; administered as concomitant medication"},{"intervention_type":"Drug","name":"Drug: Prednisone","description":"Administered orally as concomitant medication, followed by dose tapering."},{"intervention_type":"Drug","name":"Drug: Rituximab","description":"Single IV pulse administered as concomitant medication."},{"intervention_type":"Biological","name":"Biological: PR006","description":"Participants will receive a single dose of PR006, administered intra cisterna magna"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events Leading to discontinuation","time_frame":"Year 5"},{"outcome_type":"primary","measure":"Sum of adverse reactions (ARs) and suspected ARs","time_frame":"5 years"},{"outcome_type":"primary","measure":"Sum of serious ARs and serious suspected ARs","time_frame":"5 years"},{"outcome_type":"primary","measure":"Incidence of procedure or treatment-emergent AEs","time_frame":"5 years","description":"Measured by brain and spine MRI"},{"outcome_type":"primary","measure":"Change in PGRN immunogenicity in blood","time_frame":"Baseline and 12 months","description":"PGRN: progranulin protein. Measured by level of antibodies and ELISPOT"},{"outcome_type":"primary","measure":"Change in PGRN immunogenicity in CSF","time_frame":"Baseline and 12 months","description":"CSF: cerebrospinal fluid"},{"outcome_type":"primary","measure":"Change in AAV9 immunogenicity in blood","time_frame":"Baseline and 12 months","description":"Measured by level of antibodies and ELISPOT."},{"outcome_type":"primary","measure":"Change in AAV9 immunogenicity in CSF","time_frame":"Baseline and 12 months","description":"Measured by levels of antibodies."},{"outcome_type":"primary","measure":"Change in PGRN levels in blood","time_frame":"Baseline and 12 months"},{"outcome_type":"primary","measure":"Change in PGRN levels in CSF","time_frame":"Baseline and 12 months"},{"outcome_type":"secondary","measure":"Change in CDR plus NACC FTLD","time_frame":"Baseline and 12 months","description":"CDR: Clinical Dementia Rating staging instrument. NACC FTLD: National Alzheimer's Coordinating Center frontotemporal lobar degeneration domains"},{"outcome_type":"secondary","measure":"Change in NfL levels in blood","time_frame":"Baseline and 12 months","description":"NfL: neurofilament light chain"},{"outcome_type":"secondary","measure":"Change in NfL levels in CSF","time_frame":"Baseline and 12 months"}]}
{"nct_id":"NCT04625582","start_date":"2020-11-06","phase":"N/A","enrollment":340,"brief_title":"Educational Intervention for the Development of Professionals Skills in Family Medicine and Community Nursing Residents","official_title":"Modeling and Effectiveness of an Educational Intervention for the Development of Professional Skills in Family Medicine and Community Nurses Residents (PROEMPATIA)","primary_completion_date":"2022-11-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-05-31","last_update":"2020-11-13","description":"BACKGROUND The burnout syndrome among health care workers frequently rises to prevalence above 50%. One of the consequences most supported by the literature is the impoverishment of the therapeutic alliance, triggered by a loss of empathy of the clinician towards the patient due to the emotional exhaustion he or she suffers. The main factors that influence the presence of this pathology are stressors related to the organization of work. However, this equation is also influenced by individual factors that can be acted upon and which are often the only tools available for professionals. Due to the widely supported relationship of empathy, burnout and therapeutic alliance, the investigators decided to carry out a complex training plan focused on personal development in teaching units of Family and Community Care in Spain. RESEARCH QUESTION Is effective an intervention aimed to promoting the development of personal skills throughout the training of family and community care doctors and nurses? METHOD Pre-post study, comparing two educational interventions, one face-to-face (N=90) and other online (N=70), with a control group (N=170). Participants: All physicians and nurse trainees on Primary Health Care in three Spanish Health Regions who wish to participate in the study. The face-to-face intervention consists of 3 annual workshops, while the online one will be carried out by adapting the theoretical contents of the face-to-face intervention for online use and will pursue the same objectives and be fed by the same contents. The variation in the level of empathy will be quantified by means of the Interpersonal Reactivity Index (IRI) questionnaire, adjusted by burnout (Copenhagen questionnaire) and other variables such as resilience (Connor-Davidson), locus of control, social support (Oslo-3), sense of coherence (OLQ-13), age, sex, personality (Ten Item Personality Inventory, TIPI-SP) and other organisational factors. Statistical analysis with generalized lineal models and generalized additive models.","other_id":"IISGS6/2020/11","allocation":"Non-Randomized","intervention_model":"Factorial Assignment","primary_purpose":"Health Services Research","masking_description":"Single","intervention_model_description":"Ante-post evaluation study of the effectiveness of an educational intervention to improve empathy, with three arms: face-to-face, online and control group, lasting 2 years. The intervention is organized during the training of residents of Family Medicine and Community Nursing in three teaching units in different Spanish Health Authorities.","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Residents (doctors and nurses) of the three Family Medicine and Community Nursing\r\n             Training Units\r\n\r\n          -  From the 2018, 2019, 2020 and 2021 promotions\r\n\r\n          -  Who want to participate in the study and signed informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Residents who refuse to participate and / or do not sign informed consent.\r\n      ","sponsor":"Galician South Health Research Institute","sponsor_type":"Other","conditions":"Empathy|Burnout, Professional","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Face-to-face","description":"The intervention has been created specifically for this group of trainees, with the aim of acquiring or improving mediating personal skills in the processes of physical and mental well-being that help them cope with more motivation, enthusiasm and personal resources professional challenges.\r\nIt is based on conducting 4-hour face-to-face workshops, every four months throughout the period of specialized health training. They will be instrumented through group dynamics, communication exercises, leadership, corporality, and reflective and emotional writing.\r\nAudiovisual media (videos, presentations, recordings) will be used. They will be developed in person in a classroom equipped with the necessary means for training, including versatility of the space."},{"intervention_type":"Behavioral","name":"Behavioral: Online","description":"The online intervention will pursue the same objectives and will be nourished by the same content as the face-to-face intervention. The theoretical content will be adapted for online use, with the flexibility of access and organization that this entails for the participants, including videos, presentations, recordings ...\r\nGroup techniques will be carried out online, every four months during the entire period of specialized health professional training. They will be instrumented through group dynamics, communication exercises, leadership, corporality, and reflective and emotional writing."}],"outcomes":[{"outcome_type":"primary","measure":"Self-rated empathy","time_frame":"Two years","description":"Interpersonal Reactivity Index, with four subscales, scores range from 0 to 28 in each one"},{"outcome_type":"secondary","measure":"Self-rated burnout","time_frame":"Two years","description":"Copenhagen Burnout Inventory, with three subdimensions, \". Scores of 50 to 74 are considered 'moderate', 75-99 are high, and a score of 100 is considered severe burnout"}]}
{"nct_id":"NCT04747366","start_date":"2020-11-06","enrollment":750,"brief_title":"Analysis of the Pathophysiology and Pathology of Coronavirus Disease 2019 (COVID-19), Including Chronic Morbidity","official_title":"National Pandemic Cohort Network - High-resolution Platform (HAP) Analysis of the Pathophysiology and Pathology of Coronavirus Disease 2019 (COVID-19), Including Chronic Morbidity","primary_completion_date":"2025-11-01","study_type":"Observational [Patient Registry]","rec_status":"Recruiting","completion_date":"2025-11-30","last_update":"2021-02-10","description":"NAPKON-HAP is the deep phenotyping platform of the National Pandemic Cohort Network (NAPKON) in Germany. NAPKON is a data and biospecimen collection of patients with COVID-19 and is part of the University Medicine Network (NUM) in Germany. The primary objective of the study is to provide a comprehensive collection of data and biosamples for researchers from national consortia and for participation in international research collaborations for studying COVID-19 and future pandemics. Data is collected from patients with COVID-19 three times per week during their hospitalization and at follow-up visits after hospital discharge 3, 6, 12, 24, and 36 months after symptom onset. Data include epidemiological and demographic parameters, medical history and potential risk factors, documentation of routine medical procedures, and clinical course, including different patterns of organ involvement, quality of care, morbidity, and quality of life. Moreover, extensive serial high-quality bio sampling consisting of various sample types is performed to allow deep molecular, immunological, and virological phenotyping. Patients not requiring Intensive Care Unit (ICU)/ Intermediate Care (IMC) treatment will receive 7 and patients requiring ICU/IMC treatment will receive 16 full-phenotyping visits including sampling for biobanking. During hospitalisation the planned blood sampling rate in total is 35 ml at each visit. The total amounts and/or sampling dates may differ according to the ethics committee's regulations for different study centers. At follow-up visits, the clinical assessment includes an update of the medical history and recent medical events from which additional clinical data is collected (i.e. outpatient CT-scans, echocardiography, external laboratory data). Clinical symptoms are recorded and a physical examination will be performed. Vital signs are recorded and routine blood testing and biosampling is continued. Quality of life is measured with patient-reported outcome questionnaires. Follow-up visits at months 3 and 12 are \"deep phenotyping\" visits with a comprehensive and detailed set of examinations. In the following visits at months 24 and 36, only examinations with pathologic results from the last deep phenotyping visit at month 12 will be performed. A shorter follow-up visit to record quality of life, recent medical events and with a reduced number of examinations focusing on cardiorespiratory performance will take place at month 6. In case of relevant medical events, new medical information or changes in the participants health status, an unscheduled visit can take place anytime within the entire study period. Data collection during follow up includes standardized quality of life assessment including PROMIS (Patient-Reported Outcomes Measurement Information System). The pulmonary characterization will include body plethysmography, diffusion capacity, respiratory muscles strength measurement, spiroergometry, capillary blood gas analysis and lung imaging studies (low-dose Computed Tomography (CT), Magnetic Resonance Imaging (MRI) of the lung). Cardiological phenotyping includes echocardiography, electrocardiogram (ECG), 24h-ECG, 24h-blood pressure monitoring, stress cardiac MRI and pulse wave analysis. Neurocognitive testing includes brain MRI, electroencephalogram (EEG), somatosensory testing, refractometry (Visit 3 and 12 months), physical activity test, neurocognitive tests, somatosensory phenotyping, taste- and smell-test. Endocrinological phenotyping will incorporate Advanced Glycation Endproducts (AGE) reader, continuous glucose monitoring for 14 days, Air Displacement Plethysmography (ADP) or bioelectrical impedance analysis (BIA).","other_id":"NAPKON-HAP","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"COVID-19 patients, hospitalised at any of the participating hospitals (see study sites)\r\n        over the age of 18 years, who are willing and deemed able to participate in the study","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age  18 years\r\n\r\n          -  Willingness to participate in the study (consent to participate by patient or\r\n             appropriate legal representative) or inclusion via deferred consent\r\n\r\n          -  Hospitalization at time of enrollment\r\n\r\n          -  Positive evidence for SARS-CoV-2 infection with PCR (polymerase chain reaction) or\r\n             initial positive rapid diagnostic test in conjunction with typical clinical symptoms,\r\n             confirmed by a later positive PCR test.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Refusal to participate by patient, or appropriate legal representative\r\n\r\n          -  Any condition that prohibits supplemental blood-sampling beyond routine blood drawing\r\n      ","sponsor":"Charite University, Berlin, Germany","sponsor_type":"Other","conditions":"Covid19","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Changes in Patient-reported Quality of life recorded with the help of the European Quality of Life 5 Dimensions 5 Level Version (Eq5d5l) questionnaire","time_frame":"day 1 of enrollment in the study, immediately before discharge, 3, 12, 24 and 36 months after symptom onset","description":"Health related quality of life after hospital discharge will be assessed with the questionnaire European Quality of Life 5 Dimensions 5 Level Version (Eq5d5l)"},{"outcome_type":"primary","measure":"Changes in Patient-reported Quality of life recorded with the help of the Short Form Health 36 (Sf36)","time_frame":"day 1 of enrollment in the study, immediately before discharge, 3, 12, 24 and 36 months after symptom onset","description":"Health related quality of life after hospital discharge will be assessed with the questionnaire Short Form Health 36 (Sf36)"},{"outcome_type":"primary","measure":"Changes in Patient-reported Quality of life recorded with the help of the Patient-Reported Outcomes Measurement Information System (PROMIS Profile)","time_frame":"day 1 of enrollment in the study, immediately before discharge, 3, 12, 24 and 36 months after symptom onset","description":"Health related quality of life after hospital discharge will be assessed with the questionnaire Patient-Reported Outcomes Measurement Information System (PROMIS Profile)"},{"outcome_type":"primary","measure":"Changes in Patient-reported Quality of life recorded with the help of the Neuropathy Questionnaire (Mnsi)","time_frame":"day 1 of enrollment in the study, immediately before discharge, 3, 12, 24 and 36 months after symptom onset","description":"Health related quality of life after hospital discharge will be assessed with the questionnaire Neuropathy Questionnaire (Mnsi)"},{"outcome_type":"primary","measure":"Changes in Patient-reported Quality of life recorded with the help of the Trauma Patient Health Questionnaire","time_frame":"day 1 of enrollment in the study, immediately before discharge, 3, 12, 24 and 36 months after symptom onset","description":"Health related quality of life after hospital discharge will be assessed with the questionnaire Trauma Patient Health Questionnaire"},{"outcome_type":"primary","measure":"Changes in Patient-reported Quality of life recorded with the help of the PTSD (Post-traumatic stress disorder) Checklist for Diagnostic and Statistical Manual of Mental Disorders 5 (PCL-5).","time_frame":"day 1 of enrollment in the study, immediately before discharge, 3, 12, 24 and 36 months after symptom onset","description":"Health related quality of life after hospital discharge will be assessed with the PTSD (Post-traumatic stress disorder) Checklist for Diagnostic and Statistical Manual of Mental Disorders 5 (PCL-5). The PTSD Checklist for DSM-5 is a 20-questions self-report measure that assesses the presence and severity of PTSD symptoms."},{"outcome_type":"primary","measure":"Changes in Patient-reported Quality of life recorded with the help of the National Eye Institute Visual Function Questionnaire (NEI-VFQ)","time_frame":"day 1 of enrollment in the study, immediately before discharge, 3, 12, 24 and 36 months after symptom onset","description":"Health related quality of life after hospital discharge will be assessed with the questionnaire National Eye Institute Visual Function Questionnaire (NEI-VFQ)"},{"outcome_type":"primary","measure":"Changes in Patient-reported Quality of life recorded with the help of the St. George's Respiratory Questionnaire (SGRQ)","time_frame":"day 1 of enrollment in the study, immediately before discharge, 3, 12, 24 and 36 months after symptom onset","description":"Health related quality of life after hospital discharge will be assessed with the questionnaire St. George's Respiratory Questionnaire (SGRQ)"},{"outcome_type":"secondary","measure":"Changes in the clinical score Berlin ARDS (acute respiratory distress syndrome) severity score (if provided)","time_frame":"every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks","description":"At each study visit on the ICU ward, the Berlin ARDS (acute respiratory distress syndrome) severity score will be assessed (if provided in the clinical information system)."},{"outcome_type":"primary","measure":"Changes in neruocognitive testing with Cambridge Neuropsychological Test Automated Battery (CANTAB)","time_frame":"at follow-up visits (3 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results)","description":"CANTAB tests can detect changes in neuropsychological performance and include tests of working memory, learning and executive function; visual, verbal and episodic memory; attention, information processing and reaction time; social and emotion recognition, decision making and response control."},{"outcome_type":"primary","measure":"Changes in neruocognitive testing with Montreal Cognitive Assessment Test (MOCA)","time_frame":"at follow-up visits (3 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results)","description":"This test is a screening procedure to determine cognitive deficits. Central cognitive functions are examined using 11 task complexes. This includes time and spatial orientation, learning and memory, attention, language and language skills, reading, writing, drawing and calculating (test duration approx. 10 minutes)."},{"outcome_type":"primary","measure":"Changes in blood pressure measured during spiroergometry testing","time_frame":"at follow-up visits (3 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results)","description":"Spiroergometry (spirometry while the participant exercises on a bicycle ergometer) is used to evaluate physical performance and fitness. Using spiroergometry blood pressure is measured during the test and compared with normative values."},{"outcome_type":"primary","measure":"Changes in sensomotory testing with the questionnaire for peripheral neuropathy (Michigan Neuropathy Screening Instrument, MNSI)","time_frame":"at follow-up visits (3 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results)","description":"The MNSI will be used to screen patients for peripheral neuropathy."},{"outcome_type":"primary","measure":"Changes in sensomotory testing with the questionnaire (painDETECT-questionnaire, pDQ)","time_frame":"at follow-up visits (3 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results)","description":"PainDETECT will be used to screen patients for for neuropathic pain."},{"outcome_type":"primary","measure":"Changes in Quantitative sensory testing (QST)","time_frame":"at follow-up visits (3 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results)","description":"Quantitative sensory testing (QST) is a method for semiquantative evaluation of somatosensory nervous system disorders, including chronic pain and pain related to various diseases. It essentially determines the sensation and pain thresholds for cold and warm temperatures, and the vibration sensation threshold by stimulating the skin and comparing the results to normative values."},{"outcome_type":"primary","measure":"Changes in Point-of-care neurography","time_frame":"at follow-up visits (3 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results)","description":"Point-of-care neuography measures nerve conduction using a point-of-care device (DPNcheck, Neurometrix Inc, USA)."},{"outcome_type":"primary","measure":"Changes in pulmonary function assessed by body plethysmography","time_frame":"immediately before discharge, at follow-up visits (3, 6 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results)","description":"Body plethysmography will yield information on the static and dynamic lung volumes to assess obstructive and restrictive ventilation patterns."},{"outcome_type":"primary","measure":"Changes in pulmonary function assessed by single breath CO (carbon monoxide) diffusion capacity (DLCO)","time_frame":"immediately before discharge, at follow-up visits (3, 6 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results)","description":"The DLCO test provides a general assessment of the lungs' ability to take up oxygen from the inspiratory air and to release carbon dioxide."},{"outcome_type":"primary","measure":"Changes in heart rate measured with ECG (Electrocardiogram) during spiroergometry testing","time_frame":"at follow-up visits (3 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results)","description":"Spiroergometry (spirometry while the participant exercises on a bicycle ergometer) is used to evaluate physical performance and fitness. ECG is a test, used to monitor the electrical activity of the heart. Standard placement of 12-lead electrodes will be used. The patient´s heart rate will be assessed longitudinally and compared to normative values."},{"outcome_type":"primary","measure":"Changes in the oxygen saturation of the blood measured during spiroergometry testing","time_frame":"at follow-up visits (3 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results)","description":"Spiroergometry (spirometry while the participant exercises on a bicycle ergometer) is used to evaluate physical performance and fitness. Two blood samples are taken 2 hours apart. The first one is taken before the spiroergometry test and the second one - 120 minutes after the first one. The total concentration of carbon dioxide (ctCO2) of the blood is measured and compared with normative values."},{"outcome_type":"primary","measure":"Changes in the total concentration of carbon dioxide (ctCO2) of the blood measured during spiroergometry testing","time_frame":"at follow-up visits (3 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results)","description":"Spiroergometry (spirometry while the participant exercises on a bicycle ergometer) is used to evaluate physical performance and fitness. The carbon dioxide content of the blood is measured during the test and compared with normative values."},{"outcome_type":"primary","measure":"Changes in the pH value of the blood measured during spiroergometry testing","time_frame":"at follow-up visits (3 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results)","description":"Spiroergometry (spirometry while the participant exercises on a bicycle ergometer) is used to evaluate physical performance and fitness. Two blood samples are taken 2 hours apart. The first one is taken before the spiroergometry test and the second one - 120 minutes after the first one. The pH value of the blood is measured and compared with normative values. The pH value describes how acidic or basic the blood is."},{"outcome_type":"primary","measure":"Changes in the bicarbonate content of the blood measured during spiroergometry testing","time_frame":"at follow-up visits (3 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results)","description":"Spiroergometry (spirometry while the participant exercises on a bicycle ergometer) is used to evaluate physical performance and fitness. Two blood samples are taken 2 hours apart. The first one is taken before the spiroergometry test and the second one - 120 minutes after the first one. The bicarbonate content of the blood is measured and compared with normative values. Bicarbonate is a form of carbon dioxide."},{"outcome_type":"secondary","measure":"Changes in the clinical score APACHE (Acute Physiology and Chronic Health Evaluation) Score","time_frame":"upon admission to ICU","description":"At each study visit on the ICU ward, the APACHE (Acute Physiology and Chronic Health Evaluation) score will be assessed (if provided in the clinical information system)."},{"outcome_type":"primary","measure":"Changes in the blood lactate levels during spiroergometry testing","time_frame":"at follow-up visits (3 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results)","description":"Spiroergometry (spirometry while the participant exercises on a bicycle ergometer) is used to evaluate physical performance and fitness. Two blood samples are taken 2 hours apart. The first one is taken before the spiroergometry test and the second one - 120 minutes after the first one. The lactate saturation is measured and compared with normative values."},{"outcome_type":"primary","measure":"Changes in the partial pressure of carbon dioxide (pCO2) of the blood measured during spiroergometry testing","time_frame":"at follow-up visits (3 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results)","description":"Spiroergometry (spirometry while the participant exercises on a bicycle ergometer) is used to evaluate physical performance and fitness. Two blood samples are taken 2 hours apart. The first one is taken before the spiroergometry test and the second one - 120 minutes after the first one. The partial pressure of carbon dioxide (pCO2) of the blood is measured and compared with normative values."},{"outcome_type":"primary","measure":"Changes in heart rhythm type measured with ECG (Electrocardiogram) during spiroergometry testing","time_frame":"at follow-up visits (3 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results","description":"Spiroergometry (spirometry while the participant exercises on a bicycle ergometer) is used to evaluate physical performance and fitness. ECG is a test, used to monitor the electrical activity of the heart. Standard placement of 12-lead electrodes will be used. The patient´s heart rhythm will be assessed. Any abnormalities (too slow, too fast, irregular) will be documented and subsequently clinical consequences are being taken."},{"outcome_type":"primary","measure":"Changes in time intervals of PQ measured with ECG (Electrocardiogram) during spiroergometry testing","time_frame":"at follow-up visits (3 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results)","description":"Spiroergometry (spirometry while the participant exercises on a bicycle ergometer) is used to evaluate physical performance and fitness. ECG is a test, used to monitor the electrical activity of the heart. Standard placement of 12-lead electrodes will be used. The time interval of PQ corresponds to the time interval from the beginning of the P wave to the beginning of the Q wave of the QRS complex. The time interval of PQ gives us information about the time required for the action potential to be transmitted from the atria to the ventricles. The recorded PQ time will be compared to normative values. In case of delayed PQ times, further diagnostic is carried out according to current guidelines."},{"outcome_type":"primary","measure":"Changes in time intervals of QRS measured with ECG (Electrocardiogram) during spiroergometry testing","time_frame":"at follow-up visits (3 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results)","description":"Spiroergometry (spirometry while the participant exercises on a bicycle ergometer) is used to evaluate physical performance and fitness. ECG is a test, used to monitor the electrical activity of the heart. Standard placement of 12-lead electrodes will be used. The QRS complex is combination of the Q wave, R wave and S wave. The time interval of QRS corresponds to the time needed for ventricular depolarization. The recorded QRS time will be compared to normative values. In case of new diagnosed bundle blocks, further diagnostic is carried out according to current guidelines."},{"outcome_type":"secondary","measure":"Changes in the clinical score BPS (behavioural pain scale) pain score","time_frame":"every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks","description":"At each study visit on ICU ward the BPS (behavioural pain scale) pain score will be assessed (if provided in the clinical information system)."},{"outcome_type":"primary","measure":"Changes in time intervals of QT measured with ECG (Electrocardiogram) during spiroergometry testing","time_frame":"at follow-up visits (3 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results)","description":"Spiroergometry (spirometry while the participant exercises on a bicycle ergometer) is used to evaluate physical performance and fitness. ECG is a test, used to monitor the electrical activity of the heart. Standard placement of 12-lead electrodes will be used. The time interval of QT corresponds to the time interval from the beginning of the Q wave to the end of the T wave. The time interval of QT gives us information about the time required for ventricular depolarisation and repolarisation. The recorded QT time will be compared to normative values. In case of abnormal QT times, further diagnostic is carried out according to current guidelines."},{"outcome_type":"primary","measure":"Deviations in the ST segment depicted with the use of ECG (Electrocardiogram) during spiroergometry testing","time_frame":"at follow-up visits (3 and 12 months after symptom onset and 24 and 36 months after symptom onset (only in case of abnormal results)","description":"Spiroergometry (spirometry while the participant exercises on a bicycle ergometer) is used to evaluate physical performance and fitness. ECG is a test, used to monitor the electrical activity of the heart. Standard placement of 12-lead electrodes will be used. The ST-segment is a section between the end of the S wave and the beginning of the T wave and reflects the depolarized state and initial repolarization of the ventricles. Deviations in the ST segment (elevation or depression) will be documented. In case of ST segment elevation or depression, further diagnostic is carried out according to current guidelines."},{"outcome_type":"secondary","measure":"Changes in body temperature","time_frame":"every day during hospitalisation (from date of admission in trial until date of discharge or date of death, assessed up to 100 weeks","description":"Assessment of the patient´s body temperature will be performed at all visits during the acute phase."},{"outcome_type":"secondary","measure":"Changes in blood pressure","time_frame":"every day during hospitalisation (from date of admission in trial until date of discharge or date of death, assessed up to 100 weeks","description":"Assessment of the patient´s blood pressure will be performed at all visits during the acute phase."},{"outcome_type":"secondary","measure":"Changes in heart rate","time_frame":"every day during hospitalisation (from date of admission in trial until date of discharge or date of death, assessed up to 100 weeks","description":"Assessment of the patient´s heart rate will be performed at all visits during the acute phase."},{"outcome_type":"secondary","measure":"Changes in breath frequency (respiratory rate)","time_frame":"every day during hospitalisation (from date of admission in trial until date of discharge or date of death, assessed up to 100 weeks","description":"Assessment of the patient´s breath frequency (respiratory rate) will be performed at all visits during the acute phase."},{"outcome_type":"secondary","measure":"Changes in peripheral oxygen saturation","time_frame":"every day during hospitalisation (from date of admission in trial until date of discharge or date of death, assessed up to 100 weeks","description":"Assessment of the patient´s peripheral oxygen saturation will be performed at all visits during the acute phase."},{"outcome_type":"secondary","measure":"Changes in the clinical score SOFA (sequential organ failure assessment)","time_frame":"at primary admission to hospital, upon admission to ICU ward, every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks","description":"At each study visit on the ICU ward, the SOFA score will be assessed (if provided in the clinical information system)."},{"outcome_type":"secondary","measure":"Changes in the Katz Index","time_frame":"at follow-up visits (3, 12, 24 and 36 months after symptom onset)","description":"The changes in the Katz Index will be recorded and evaluated, if provided."},{"outcome_type":"secondary","measure":"Changes in the clinical score NEWS (National Early Warning Score)","time_frame":"day 1 of enrollment in the study (day of hospitalization), if available","description":"At primary admission to hospital NEWS (National Early Warning Score) will be assessed (if provided in the clinical information system)."},{"outcome_type":"secondary","measure":"Changes in the clinical score qSOFA Score (quick sequential organ failure assessment)","time_frame":"day 1 of enrollment in the study (day of hospitalization), if available","description":"At primary admission to hospital qSOFA Score will be assessed (if provided in the clinical information system)."},{"outcome_type":"secondary","measure":"Changes in the Barthel Index","time_frame":"day 1 of enrollment in the study, every Monday, Wednesday and Friday during hospitalisation, (assessed up to 100 weeks?), immediately before discharge, at follow up visits 3, 12, 24 and 36 months after symptom onset","description":"The changes in the Barthel Index score will be recorded and evaluated, if provided."},{"outcome_type":"secondary","measure":"Changes in the Frailty score","time_frame":"day 1 of enrollment in the study, every Monday, Wednesday and Friday during hospitalisation, (assessed up to 100 weeks?), immediately before discharge, at follow up visits 3, 12, 24 and 36 months after symptom onset","description":"At each study visit during hospitalization (visits are conducted 3 times a week until discharge) the Frailty score will be assessed (if provided in the clinical information system)."},{"outcome_type":"secondary","measure":"Changes in the clinical score Murray Score","time_frame":"every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks","description":"At each study visit on ICU ward the Murray Score will be assessed (if provided in the clinical information system)."},{"outcome_type":"secondary","measure":"Changes in the clinical score Glasgow Coma Scale (GCS)","time_frame":"upon admission to ICU ward, every Monday, Wednesday and Friday ICU ward stay, assessed up to 100 weeks","description":"At each study visit on ICU ward the Glasgow Coma Scale score will be assessed (if provided in the clinical information system)."},{"outcome_type":"secondary","measure":"Changes in the clinical score RASS (Richmond Agitation Sedation Scale)","time_frame":"upon admission to ICU ward, every Monday, Wednesday and Friday ICU ward stay, assessed up to 100 weeks","description":"At each study visit on ICU ward the RASS (Richmond Agitation Sedation Scale)will be assessed (if provided in the clinical information system)."},{"outcome_type":"secondary","measure":"Changes in the clinical score CAM-ICU (Score Confusion Assessment Method for Intensive Care Unit)","time_frame":"every Monday, Wednesday and Friday during ICU ward stay,assessed up to 100 weeks","description":"At each study visit on ICU ward the CAM-ICU (Score Confusion Assessment Method for Intensive Care Unit) score will be assessed (if provided in the clinical information system)."},{"outcome_type":"secondary","measure":"Changes in the clinical score SAPSII (Simplified acute physiology Score II)","time_frame":"every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks","description":"At each study visit on ICU ward the SAPSII (Simplified acute physiology Score II) will be assessed (if provided in the clinical information system)."},{"outcome_type":"secondary","measure":"Changes in the clinical score NRS (numeric rating scale) pain score","time_frame":"every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks","description":"At each study visit on ICU ward the NRS (numeric rating scale) pain score will be assessed (if provided in the clinical information system)."},{"outcome_type":"secondary","measure":"Changes in the clinical score CPOT (Critical Care Pain Observation tool)","time_frame":"every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks","description":"At each study visit on ICU ward the CPOT (Critical Care Pain Observation tool) score will be assessed (if provided in the clinical information system)."},{"outcome_type":"secondary","measure":"Changes in the clinical score DDS (Delirium detection score)","time_frame":"every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks","description":"At each study visit on ICU ward the DDS (Delirium detection score) will be assessed (if provided in the clinical information system)."},{"outcome_type":"secondary","measure":"Changes in the checked items on the ICDSC (Intensive Care Delirium Screening checklist)","time_frame":"every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks","description":"At each study visit on ICU ward the ICDSC (Intensive Care Delirium Screening checklist) will be assessed (if provided in the clinical information system)."},{"outcome_type":"secondary","measure":"Changes in the heart time volume","time_frame":"every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks","description":"Assessment of the patient´s heart time volume will be performed at all visits during their stay in the ICU ward."},{"outcome_type":"secondary","measure":"Changes in the cardiac index","time_frame":"every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks","description":"Assessment of the patient´s cardiac index will be performed at all visits during their stay in the ICU ward."},{"outcome_type":"secondary","measure":"Changes in EVLWI (Extravascular Lung Water Index)","time_frame":"every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks","description":"Assessment of the patient´s Extravascular Lung Water Index measurement will be performed at all visits during their stay in the ICU ward."},{"outcome_type":"secondary","measure":"Changes in Systemic Vascular Resistance Index (SVRI)","time_frame":"every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks","description":"Assessment of the patient´s Systemic Vascular Resistance Index (SVRI) measurement will be performed at all visits during their stay in the ICU ward."},{"outcome_type":"secondary","measure":"Changes in ITBVI (Intrathoracic Blood Volume Index)","time_frame":"every Monday, Wednesday and Friday during ICU ward stay, assessed up to 100 weeks","description":"Assessment of the patient´s ITBVI (Intrathoracic Blood Volume Index) measurement will be performed at all visits during their stay in the ICU ward."},{"outcome_type":"secondary","measure":"Changes in the score WHO (World Health Organisation) clinical ordinal scale","time_frame":"every day during hospital stay (from day of admission until discharge from hospital, assessed up to 100 weeks) and at follow-up visits (3, 12, 24 and 36 months after symptom onset)","description":"Changes in the patient´s score on the WHO clinical ordinal scale, used to measure illness severity over time will be assessed."},{"outcome_type":"secondary","measure":"Changes in the NYHA (New York Heart Association) score","time_frame":"at deep phenotyping during follow-up visits (3 and 12 months after symptom onset)","description":"The changes in the NYHA (New York Heart Association) score will be recorded and evaluated, if provided."},{"outcome_type":"secondary","measure":"Changes in the Post-COVID-19 Functional Status (PCFS) scale","time_frame":"at follow-up visits (3, 12, 24 and 36 months after symptom onset)","description":"The changes in the Post-COVID-19 Functional Status (PCFS) scale will be recorded and evaluated, if provided."},{"outcome_type":"secondary","measure":"Changes in the National Institutes of Health Stroke Scale (NIHSS)","time_frame":"at deep phenotyping during follow-up visits (3 and 12 months after symptom onset)","description":"The changes in the National Institutes of Health Stroke Scale (NIHSS) will be recorded and evaluated, if provided."},{"outcome_type":"secondary","measure":"Changes in the Rose Dyspnea Scale","time_frame":"at deep phenotyping during follow-up visits (3 and 12 months after symptom onset)","description":"The changes in the Rose Dyspnea Scale will be recorded and evaluated, if provided."}]}
{"nct_id":"NCT04551443","start_date":"2020-11-01","phase":"Phase 2","enrollment":200,"brief_title":"WJMSCs Anti-inflammatory Therapy in Acute Myocardial Infarction","official_title":"Randomised, Double-blind, Placebo-controlled, Intravenous Infusion Human Wharton' Jelly-derived Mesenchymal Stem Cells in Patients With Acute Myocardial Infarction","primary_completion_date":"2021-12-30","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2022-12-30","last_update":"2020-09-16","description":"Cumulative evidence has demonstrated that cardiac repair after acute myocardial infarction (AMI) is characterized by a series of time-dependent events orchestrated by the innate immune system. This begins immediately after the onset of necrotic cell death with intense sterile inflammation and myocardial infiltration of a variety of immune cell subtypes including monocytes and macrophages during the first several days after MI. There is increasing evidence to suggest inflammation is not limited to the infarcted myocardium and systemic imbalances in the post-infarct inflammatory cascade can exacerbate adverse remodelling beyond the infarct site. Therefore, it is very important that therapies seek to target the intricate balance between pro- and antiinflammatory pathways timely after AMI. Human mesenchymal stem cells (hMSCs) have been shown to exhibit immunomodulation, angiogenesis, and paracrine secretion of bioactive factors that can attenuate inflammation and promote tissue regeneration, making them a promising cell source for AMI therapy. However, it has been proved in our and other studies that perfusion of WJMSCs after 5 days of AMI can only slightly improve left ventricular end-diastolic volume, which is the most important indicator of left ventricular remodeling. Thus, WANIAMI Trial is a randomized, double-blind, placebo controlled, phase#study designed to assess the safety and feasibility of intravenous infusion of WJMSCs in the treatment of patients in the acute phase ( within 24h) with the both of ST-Segment-Elevation or Non-ST-Segment-Elevation AMI.","other_id":"PLAG6C","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","intervention_model_description":"Placebo Comparator: Intravenous infusion WJMSCs +standard therapy Vs placebo+ standard therapy in patients with acute myocardial infarction","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age limited  18 years at Visit 1\r\n\r\n          -  Patient must provide written informed consent\r\n\r\n          -  Have a diagnosis of acute ST-Segment-Elevation or Non-ST-Segment-Elevation myocardial\r\n             infarction as defined by any of the following criteria:\r\n\r\n          -  According to the Third Universal Definition of Myocardial Infarction Type:\r\n\r\n        Type 1 spontaneous myocardial infarction Type 2 myocardial infarction secondary to an\r\n        ischemic imbalance Type 3 myocardial infarction resulting in death when biomarker values\r\n        are unavailable Including: acute ST-Segment-Elevation or Non-ST-Segment-Elevation\r\n        myocardial infarction, creatine kinase (CK)-MB levels over three-fold the upper limit of\r\n        the reference values.\r\n\r\n          -  Successful or unsuccessful. revascularization by percutaneous coronary intervention,\r\n             within 12 hours after symptom onset with stent implantation and thrombolysis.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Myocardial infarction related to stent thrombosis; Myocardial infarction related to\r\n             restenosis\r\n\r\n          -  Myocardial infarction related to coronary artery bypass grafting (CABG)\r\n\r\n          -  Have a hematologic abnormality as evidenced by hematocrit <25% , white blood cell\r\n             <2500/u L or platelet values<100000/u L without another explanation.\r\n\r\n          -  Have liver dysfunction , as evidenced by enzymes (aspartate aminotransferase and\r\n             alanine aminotransferase) >3 the upper limits of normal\r\n\r\n          -  Have a coagulopathy (international normalized ratio > 1.3) not because of a reversible\r\n             cause (ie, coumadin)\r\n\r\n          -  Be an organ transplant recipient\r\n\r\n          -  Have a clinical history of malignancy within 5 y except curatively treated basal cell\r\n             carcinoma, squamous cell carcinoma, or cervical carcinoma.\r\n\r\n          -  Have a noncardiac condition that limits lifespan to <1y.\r\n\r\n          -  Have a history of drug or alcohol abuse within the past 24 m.\r\n\r\n          -  Be serum positive for human immunodeficiency virus, hepatitis B surface antigen, or\r\n             hepatitis C.\r\n\r\n          -  Be a female who is pregnant, nursing, or of childbearing potential who is not\r\n             practicing effective contraceptive methods.\r\n      ","sponsor":"Navy General Hospital, Beijing","sponsor_type":"Other","conditions":"Acute Myocardial Infarction","interventions":[{"intervention_type":"Biological","name":"Biological: Intravenous infusion placebo","description":"Intravenous infusion placebo or WJMSCs in patients with AMI"},{"intervention_type":"Biological","name":"Biological: Intravenous infusion WJMSCs","description":"Intravenous infusion WJMSCs or placebo in patients with AMI"}],"outcomes":[{"outcome_type":"primary","measure":"Any composite of major adverse cardiovascular events","time_frame":"12 months","description":"The main safety endpoints was the first occurrence of a major adverse cardiovascular event (a composite of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death) and hospitalization for unstable angina that led to urgent coronary revascularization within 12 months."},{"outcome_type":"primary","measure":"Checking patient LVEF","time_frame":"6 months","description":"The main feasibility endpoints were defined as the change in LVEF, infarct size as determined by MRI and perfusion defect as assessed by MIBI SPECT from baseline to 6 months."},{"outcome_type":"primary","measure":"Checking patient infarct size","time_frame":"6 months","description":"The main feasibility endpoints were defined as the change in infarct size"},{"outcome_type":"primary","measure":"checking patient perfusion defect.","time_frame":"6 months","description":"The main feasibility endpoints were defined as non significant perfusion defect"},{"outcome_type":"secondary","measure":"Coronary disease","time_frame":"12 months","description":"Secondary end points included death from a composite of major adverse card cardiovascular events plus any coronary revascularization within 12 months."},{"outcome_type":"secondary","measure":"Coronary congestive heart failure","time_frame":"12 months","description":"Secondary end points included death from hospitalization for congestive heart failure within 12 months."},{"outcome_type":"secondary","measure":"Coronary changes in hsCRP","time_frame":"12 months","description":"Secondary end points included the level change of hsCRP within 12 months."}]}
{"nct_id":"NCT04780984","start_date":"2020-11-01","phase":"Phase 2","enrollment":116,"brief_title":"Tiotropium Bromide Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease","official_title":"A Phase 2, Randomized, Partially-blinded, Parallel Group, Dose-ranging Study to Assess the Pharmacodynamics, Relative Bioavailability, and Safety of of Tiotropium Bromide Inhalation Solution in Subjects With COPD","primary_completion_date":"2021-04-20","study_type":"Interventional","rec_status":"Completed","completion_date":"2021-04-26","last_update":"2021-05-10","description":"A Phase 2, Randomized, Partially-blinded, Parallel Group, Dose-ranging Study to Assess the Pharmacodynamics, Relative Bioavailability, and Safety of Three Doses of Tiotropium Bromide Inhalation Solution in Subjects with Chronic Obstructive Pulmonary Disease","other_id":"Neph-0002","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":40,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Males and nonpregnant females, ages 40 to 80 years old, inclusive.\r\n\r\n          -  On a stable COPD medication regimen defined as: no new medications for or changes to\r\n             medications (dose/frequency) used to manage COPD within 60 days of screening.\r\n\r\n          -  Willing and able to give informed consent and follow all study procedures and\r\n             requirements.\r\n\r\n          -  Body mass index <35.\r\n\r\n          -  Female subjects of child-bearing potential1 who are non-lactating, are using and agree\r\n             tocontinue using an acceptable method of contraception for at least 4 weeks prior to\r\n             first dose of study drug and until 12 weeks after last dose, and have a negative serum\r\n             pregnancy test during screening. Adequate contraception is defined as a contraceptive\r\n             method with a failure rate of less than 1% per year when used consistently and\r\n             correctly and when applicable, in accordance with the product label, for example:\r\n             abstinence from penile-vaginal intercourse; oral contraceptives, either combined or\r\n             progestogen alone; injectable progestogen; implants of etonogestrel or levonorgestrel;\r\n             estrogenic vaginal ring; percutaneous contraceptive patches; intrauterine device or\r\n             intrauterine system; male partner sterilization at least 6 months prior to the female\r\n             subject's screening visit, and this male is the sole partner for that subject (the\r\n             information on the male partner's sterility can come from the site personnel's review\r\n             of the subject's medical records or interview with the subject on her medical\r\n             history); male condom combined with a vaginal spermicide (foam, gel, film, cream, or\r\n             suppository); male condom combined with a female diaphragm, either with or without a\r\n             vaginal spermicide (foam, gel, film, cream, or suppository).\r\n\r\n          -  Female subjects of childbearing potential who agree not to donate an ova during the\r\n             study and for at least 30 days after the last dose of study drug.\r\n\r\n          -  If male, agrees to use a condom with spermicide (note: no restrictions are required\r\n             for a vasectomized male provided that his vasectomy was  4 months prior to the\r\n             Screening Visit).\r\n\r\n          -  Diagnosis of COPD, as defined by American Thoracic Society Global Initiative for\r\n             Chronic Obstructive Lung Disease criteria\r\n\r\n          -  Post-bronchodilator FEV1 30% and 79%\r\n\r\n          -  Post-bronchodilator FEV1/FVC ratio 70%\r\n\r\n          -  Current or former smoker with a history of  10 pack-year history\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any condition that, in the opinion of the investigator, would interfere with the\r\n             subject'sability to complete the study, would interfere with the interpretation of\r\n             safety or efficacy, or would present an undue risk to the subject. In cases of\r\n             uncertainty, the investigator may contact the medical monitor for clarification.\r\n\r\n          -  Known respiratory disorders other than COPD that, in the opinion of the investigator,\r\n             may present an unacceptable safety risk to a subject's study participation or could\r\n             confound the interpretation of the study safety or efficacy results. Examples include,\r\n             but are not limited to: alpha-1 antitrypsin deficiency, cystic fibrosis, significant\r\n             asthma, active bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension,\r\n             pulmonary edema, or interstitial lung disease.\r\n\r\n          -  Currently taking a non-selective beta blocker. Subjects who have been on a stable dose\r\n             of a cardioselective beta blocker for at least 3 months prior to screening are not\r\n             excluded (examples of cardioselective beta blockers are: metoprolol, atenolol,\r\n             bisoprolol, and nebivolol). Topical beta blockers for ophthalmologic conditions are\r\n             permitted.\r\n\r\n          -  Uncontrolled diabetes defined as HbA1c > 8.0%.\r\n\r\n          -  Renal impairment defined as estimated glomerular filtration rate <50 ml/min/1.73 m2 as\r\n             calculated by the Chronic Kidney Disease Epidemiology Collaboration equation.\r\n\r\n          -  Liver disease as defined as one or more of the following:\r\n\r\n               1. AST or ALT > 2 times the upper limit of normal (ULN).\r\n\r\n               2. Total bilirubin > 2 times the ULN (subjects with bilirubin elevation patterns\r\n                  consistent with Gilbert's disease are permitted).\r\n\r\n               3. A history of or suspected, in the opinion of the investigator, bleeding disorder.\r\n                  Subjectson therapeutic anticoagulation are not excluded if the investigator\r\n                  believes they are appropriately anticoagulated.\r\n\r\n          -  Eosinophil count >600/mm3.\r\n\r\n          -  History of a malignancy of any organ system (other than localized squamous or basal\r\n             cell carcinoma of the skin) treated or untreated within the last 2 years prior to\r\n             screening.\r\n\r\n          -  Evidence or history of a clinically significant disease or abnormality, which, in the\r\n             opinion of the investigator, would present and unacceptable safety risk to a subject's\r\n             study participation or could confound the interpretation of the study efficacy or\r\n             safety results. Examples of these conditions include, but are not limited to: NYHA\r\n             Class II or higher congestive heart failure, uncontrolled hypertension, uncontrolled\r\n             coronary artery disease, thyrotoxicosis, stroke, or cardiac dysrhythmia.\r\n\r\n          -  Conditions which, in the opinion of the investigator, may contraindicate the use of an\r\n             anticholinergic agent. Examples of these conditions may include, but are not limited\r\n             to: paradoxical bronchospasm, narrow-angle glaucoma, prostatic hyperplasia, bladder\r\n             neck obstruction, chronic constipation, or altered gastrointestinal motility.\r\n\r\n          -  History of myasthenia gravis.\r\n\r\n          -  Use of oral corticosteroids or oral antibiotics within 6 weeks prior to the Screening\r\n             Visit.\r\n\r\n          -  Subjects who have a positive test result on the screening urine drug screen for banned\r\n             substances, including tetrahydrocannabinol or controlled substance(s) for which the\r\n             subject does not have a valid prescription. Subjects taking cannabidiol should also be\r\n             excluded.\r\n\r\n          -  History of allergy or hypersensitivity to anticholinergic/muscarinic receptor\r\n             antagonist agents, beta-2 adrenergic agonists, lactose/milk proteins, or specific\r\n             intolerance to aerosolized tiotropium-containing products or known hypersensitivity to\r\n             any of the proposed ingredients or components of the delivery system.\r\n\r\n          -  Hospitalization for COPD or pneumonia within 8 weeks of study enrollment.\r\n\r\n          -  Treatment for COPD exacerbation (defined as change in COPD symptoms requiring\r\n             antibiotics and/or corticosteroids) within 12 weeks prior to enrollment.\r\n\r\n          -  Have participated in pulmonary rehabilitation within 90 days of screening or are\r\n             planning to participate in pulmonary rehabilitation during the course of the study\r\n\r\n          -  History of 3 or more COPD exacerbations within 12 months prior to enrollment.\r\n\r\n          -  Inability to refrain from COPD medications as prohibited by study protocol.\r\n\r\n          -  Requires any supplemental oxygen therapy (including nocturnal oxygen).\r\n\r\n          -  Acute (viral or bacterial) upper or lower respiratory tract infection, sinusitis,\r\n             rhinitis, pharyngitis, urinary tract infection or illness within 6 weeks prior to\r\n             enrollment.\r\n\r\n          -  Abnormal and clinically significant electrocardiogram (ECG) findings, as determined by\r\n             the investigator, at screening or during treatment.\r\n\r\n          -  Lung volume reduction surgery within 12 months prior to the initiation of the study.\r\n\r\n          -  Have an oxygen saturation <91% on room air at screening measured by pulse oximetry.\r\n\r\n          -  Have participated in an investigational drug study within 30 days prior to screening.\r\n             In addition, it is necessary that at least 5 half-lives of the previously administered\r\n             investigational drug have elapsed by Visit 1.\r\n\r\n          -  Subjects currently infected with COVID-19 or subjects who have previously been\r\n             infected and have residual symptoms that, in the opinion of the investigator, would\r\n             present a safety risk to study participation or could potentially interfere with the\r\n             interpretation of safety or efficacy data in the current study. COVID-19 infection is\r\n             defined as laboratory evidence of COVID-19 infection or by a constellation of\r\n             signs/symptoms that, in the opinion of the investigator, are/were consistent with\r\n             COVID-19 infection. Note: COVID-19 vaccination is not exclusionary.\r\n      ","sponsor":"Nephron Pharmaceuticals Corporation","sponsor_type":"Industry","conditions":"Chronic Obstructive Pulmonary Disease (COPD)","interventions":[{"intervention_type":"Drug","name":"Drug: Tiotropium bromide inhalation solution","description":"Tiotropium bromide inhalation solution"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo comparator"}],"outcomes":[{"outcome_type":"primary","measure":"Change in trough forced expiratory volume in 1 second (FEV1) compared with placebo","time_frame":"22 days","description":"The primary outcome measure will be the change in trough FEV1 from baseline at Visit 4 in the 8 μg, 16 μg, and 24 μg doses of tiotropium bromide inhalation solution treatment groups compared with that of placebo, will be evaluated by using a mixed model for repeated measure (MMRM) in the mITT population."},{"outcome_type":"secondary","measure":"Change in trough FEV1 compared with placebo and Sprivia Respimat","time_frame":"22 days","description":"The secondary outcome measure will be the change in trough FEV1 from baseline at Visit 2 and Visit 3 compared with that of placebo and from baseline at Visit 4 compared with that of Sprivia Respimat"},{"outcome_type":"secondary","measure":"Change in forced vital capacity (FVC) compared with placebo and Sprivia Respimat","time_frame":"22 days","description":"The secondary outcome measure will be the change in trough forced vital capacity (FVC) from baseline at Visit 2 and Visit 3 compared with that of placebo and from baseline at Visit 4 compared with that of Sprivia Respimat"}]}
{"nct_id":"NCT04426344","start_date":"2020-10-31","phase":"N/A","enrollment":0,"brief_title":"Core Warming of COVID-19 Patients","official_title":"Core Warming of COVID-19 Patients Undergoing Mechanical Ventilation: a Randomized, Single Center Pilot Study","primary_completion_date":"2020-12-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2020-12-31","last_update":"2020-10-19","description":"This is a small scale pilot study to evaluate if core warming improves respiratory physiology of mechanically ventilated patients with COVID-19, allowing earlier weaning from ventilation, and greater overall survival. This prospective, randomized study will include 20 patients diagnosed with COVID-19, and undergoing mechanical ventilation for the treatment of respiratory failure. Patients will be randomized in a 1:1 fashion with 10 patients (Group A) randomized to undergo core warming, and the other 10 patients (Group B) serving as the control group who will not have the ensoETM device used. Patients randomized to Group A will have core warming initiated in the ICU or other clinical environment in which they are being treated after enrollment and provision of informed consent from appropriate surrogate or legally authorized representative.","other_id":"202005150","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","intervention_model_description":"Randomized, single center pilot study","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patients above the age of 18 years old.\r\n\r\n          2. Patients with a diagnosis of COVID-19 on mechanical ventilation.\r\n\r\n          3. Patient maximum baseline temperature (within previous 12 hours) < 38.3C.\r\n\r\n          4. Patients must have a surrogate or legally authorized representative able to understand\r\n             and critically review the informed consent form.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients without surrogate or legally authorized representative able to provide\r\n             informed consent.\r\n\r\n          2. Patients with contraindication to core warming using an esophageal core warming\r\n             device.\r\n\r\n          3. Patients known to be pregnant.\r\n\r\n          4. Patients with <40 kg of body mass.\r\n\r\n          5. Patients with DNR status.\r\n\r\n          6. Patients with acute stroke, post-cardiac arrest, or multiple sclerosis.\r\n\r\n          7. Patients with history of esophageal disease\r\n\r\n          8. Patients with a baseline epinephrine dose greater than 0.6 mcg/kg/min\r\n\r\n          9. Patients with atrial fibrillation, atrial flutter, or other multifocal atrial\r\n             tachycardia with a heart rate greater than 110 beats per minute.\r\n\r\n         10. Patients on 0.2 mcg/kg/min or more of norepinephrine\r\n      ","sponsor":"Washington University School of Medicine","sponsor_type":"Other","conditions":"COVID 19","interventions":[{"intervention_type":"Device","name":"Device: ensoETM device","description":"Core warming will be performed using standard technique per instructions for use for the esophageal heat transfer device. The esophageal heat transfer device will be set to 42C temperature after initial placement, and maintained at 42C for the duration of treatment. It is expected that patient temperature will increase from baseline by 1C to 2C, but due to ongoing heat loss from the patient, the expected maximum patient temperature is below 39C. The time course of illness of COVID-19 is such that most patients no longer have fever by the time of mechanical ventilation.[41] If patient temperature increases above this range and reaches 39.8C, the device will be set to an operating temperature of 40C, thereby preventing any further increase in patient temperature (ambient heat loss precludes patient from reaching device operating temperature)."}],"outcomes":[{"outcome_type":"primary","measure":"Viral load measured in tracheal aspirate 72 hours after initiation of core warming","time_frame":"72 hours","description":"This endpoint will be compared between patients receiving core warming and those randomized to undergo standard care (standard temperature management, with or without antipyretics as needed) in order to determine an initial estimate of effect size and provide data from which to design adequately powered investigation and apply appropriate statistical testing."},{"outcome_type":"secondary","measure":"PaO2/FiO2 ratio 72 hours after initiation of core warming","time_frame":"72 hours"},{"outcome_type":"secondary","measure":"Duration of mechanical ventilation","time_frame":"30 days"}]}
{"nct_id":"NCT04595227","start_date":"2020-10-30","enrollment":100,"brief_title":"Glaucoma Screening Using Dynamic Analysis of Computerized Pupillary Light Reflex Assessment Device","official_title":"Glaucoma Screening Using Dynamic Analysis of Computerized Pupillary Light Reflex Assessment Device Via Iris Recognition Techniques","primary_completion_date":"2021-04-30","study_type":"Observational","rec_status":"Recruiting","completion_date":"2021-10-01","last_update":"2021-05-07","description":"To explore an effective diagnostic tool of glaucoma through the dynamic analysis of computerized pupillary light reflex assessment device (CPLRAD) pupillography based on iris recognition techniques and investigate its feasibility in glaucoma screening.","other_id":"IRB00006761-M2020269","observational_model":"Case-Control","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"All participants are recruited from patients visiting at the Ophthalmologic Center of\r\n        Peking University Third Hospital and from the general population through advertisements.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  with open angles on gonioscopy\r\n\r\n          -  best-corrected visual acuity 0.5\r\n\r\n          -  spherical refraction within 6.0 diopters (D), and cylinder correction within 3.0 D\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  eyes with any evidence of physical abnormality of the iris or pupils on slit-lamp\r\n             examination\r\n\r\n          -  eyes with a history of trauma or inflammation\r\n\r\n          -  undergone an intraocular surgery or laser within the previous 6 months /except\r\n             uncomplicated cataract surgery\r\n\r\n          -  using systemic or topical medications that could affect pupil responses, including\r\n             pilocarpine or atropine\r\n\r\n          -  presence of any media opacities that prevented good quality optical coherence\r\n             tomography (OCT) or fundus images\r\n\r\n          -  presence of any retinal or neurological disease other than glaucoma abnormal ocular\r\n             motility that prevents binocular fixation (eg, nystagmus, strabismus)\r\n\r\n          -  with severe system diseases or psychiatric disorders\r\n      ","sponsor":"Peking University","sponsor_type":"Other","conditions":"Primary Open Angle Glaucoma|Primary Open-Angle Glaucoma, Unspecified Eye|Primary Open Angle Glaucoma of Both Eyes|Suspect Glaucoma|Ocular Hypertension","interventions":[{"intervention_type":"Device","name":"Device: Computerized pupillary light reflex assessment device","description":"CPLRAD may serve as an effective screening tool for glaucomatous optic neuropathy, since they can dynamically detect abnormal pupillary responses from a novel sequence of light stimuli and functionally-shaped stimuli. CPLRAD can collect the clinical examination data and objectively measure the pupil dynamic parameters monocularly and/or binocularly as indicators from the retina and optic nerve in glaucoma patients."}],"outcomes":[{"outcome_type":"primary","measure":"Maximum Constriction Velocity in One Eye in Different Groups","time_frame":"The test of each participant will complete the all procedures within 1 hour.","description":"The maximum constriction velocity will be calculated by the software"},{"outcome_type":"primary","measure":"Maximum Dilation Velocity in One Eye in Different Groups","time_frame":"The test of each participant will complete the all procedures within 1 hour.","description":"The maximum dilation velocity will be calculated by the software."},{"outcome_type":"primary","measure":"Pupil Constriction Amplitude(ratio) in One Eye in Different Groups","time_frame":"The test of each participant will complete the all procedures within 1 hour.","description":"The pupil constriction amplitude(ratio) will be calculated by the software."},{"outcome_type":"primary","measure":"Baseline Pupil Size in One Eye in Different Groups","time_frame":"The test of each participant will complete the all procedures within 1 hour.","description":"The baseline pupil size is measured before the stimulus on."},{"outcome_type":"primary","measure":"Baseline Pupil Size(BPZ) Asymmetry between Two Eyes in Different Groups","time_frame":"The test of each participant will complete the all procedures within 1 hour.","description":"Asymmetry is calculated by a formula:\r\nRAPD score of BPZ= 10 * log10 (baseline pupil size in right eye/baseline pupil size in left eye)"},{"outcome_type":"primary","measure":"Maximum Constriction Velocity(MCV) Asymmetry between Two Eyes in Different Groups","time_frame":"The test of each participant will complete the all procedures within 1 hour.","description":"Asymmetry is calculated by a formula:\r\nRAPD score of MCV= 10 * log10 (maximum constriction velocity in right eye/maximum constriction velocity in left eye)"},{"outcome_type":"primary","measure":"Maximum Dilation Velocity(MDV) Asymmetry between Two Eyes in Different Groups","time_frame":"The test of each participant will complete the all procedures within 1 hour.","description":"Asymmetry is calculated by a formula:\r\nRAPD score of MDV = 10 * log10 (maximum dilation velocity in right eye/maximum dilation velocity in left eye)"},{"outcome_type":"primary","measure":"Pupil Constriction Amplitude(ratio) Asymmetry between Two Eyes in Different Groups","time_frame":"The test of each participant will complete the all procedures within 1 hour.","description":"Amplitude(ratio) is calculated by: (DIAMETER resting-DIAMETER constricted) / DIAMETER resting\r\nAsymmetry was calculated by a formula:\r\nRAPD score of Amplitude = 10 * log10 (pupil constriction amplitude in right eye/pupil constriction amplitude in left eye)"}]}
{"nct_id":"NCT04180709","start_date":"2020-10-30","phase":"N/A","enrollment":44,"brief_title":"CBT to Reduce Insomnia and Improve Social Recovery in Early Psychosis","official_title":"Randomised Study of Web-based CBT Intervention (Sleepio) to Reduce Insomnia and Improve Social Recovery in Early Psychosis (CRISP)","primary_completion_date":"2022-11-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-11-30","last_update":"2020-11-03","description":"Sleep disturbances and cognitive dysfunction are consistently reported as extremely troublesome aspects of psychotic illnesses. While sleep disturbances are not included in definitions of psychosis they are associated with poor levels of daily function and impaired social recovery. Despite sleep problems being documented as co-occurring with psychosis, sleep remains unexamined as a potential therapeutic target pathway for social recovery. Specific areas of cognition are known to be associated with psychosis, sleep deficits and daily function, yet these have not been tested as possible mediators of the association between improved sleep and better daily function and social recovery. This study will examine the relationship between sleep quality, daily function and ultimately social recovery in early psychosis. A secondary aim will examine whether specified areas of cognition (i.e. attention, memory, executive function, social and emotional recognition) mediate the proposed association between sleep and social recovery. Participants will have experienced a first episode psychosis and be currently engaged with CAMEO early intervention, in Cambridgeshire and Peterborough NHS Foundation Trust (CPFT). Cameo is a service for people aged 14-65 years old who are experiencing symptoms of psychosis for the first time (http://www.cameo.nhs.uk). A publicly available, online intervention based on cognitive behavioural therapy (CBT) for insomnia (Sleepio) will be utilised to improve sleep. Participants will be randomised to receive the intervention + treatment as usual (TAU) through their CAMEO team or TAU alone over an eight-week period. The entire study will last for seventeen weeks including an eight-week follow-up period.","other_id":"M00915","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","intervention_model_description":"This is a randomised parallel study design, with five points of measurements. Participants will receive either the Sleepio online intervention + treatment as usual (TAU) or TAU alone over an 8-week period. A follow-up period will be conducted for an additional 8 weeks. The original TAU group will be offered the intervention during this period.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Experiencing or having experienced a First Episode of Psychosis (FEP) within the past\r\n             5 years.\r\n\r\n          -  Currently participating in CAMEO Early Intervention services (North or South) and\r\n             intending to continue TAU with CAMEO for at least the next 4 months.\r\n\r\n          -  Mental capacity for consent.\r\n\r\n          -  Currently experiencing threshold level (score  16 on SCI-8) of disrupted sleep.\r\n\r\n          -  Adults 18 years or older.\r\n\r\n          -  Ability to understand and follow therapeutic instructions necessary for experiment and\r\n             respond to online questionnaires.\r\n\r\n          -  Illness duration less than or equal to 5 years. Onset of illness was defined as first\r\n             contact with psychiatric services for psychotic symptoms.\r\n\r\n          -  Access to the internet.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Too unwell to viably participate in study.\r\n\r\n          -  A diagnosis of drug induced psychosis or bipolar disorder.\r\n\r\n          -  Psychotic disorder due to a medical or physical disease (i.e. considered to have an\r\n             organic basis).\r\n\r\n          -  Current drug or alcohol dependency.\r\n\r\n          -  Currently taking prescribed sleep medication or intending to do so during study.\r\n\r\n          -  Currently doing shift work.\r\n\r\n          -  Travel over 2 time zones during or within two weeks prior to assessment period.\r\n      ","sponsor":"University of Cambridge","sponsor_type":"Other","conditions":"Psychotic Disorders|Psychosis|Sleep","interventions":[{"intervention_type":"Device","name":"Device: Sleepio","description":"Sleepio is an online cognitive behavioural therapy (CBT) based intervention designed to treat insomnia, conducted is 6 sessions. The program is an automated media-rich web-based application that is driven dynamically by baseline, adherence, performance and progress data. At the beginning of each session The Prof conducts a progressive review with the participant exploring the diary data submitted the week prior that includes sleep status and pattern, as well as progress based on goals previously set by the participant. The information, support and advice are personally tailored based on underlying algorithms."}],"outcomes":[{"outcome_type":"primary","measure":"Change from baseline Work and Social Adjustment Scale (WSAS) score at week 9 of study","time_frame":"Measure completed at baseline (start of week 1) and week 9.","description":"WSAS is a simple and reliable measure of impaired functioning. Scores range from 0-40, with lower scores representing better functioning, scores 0-10 are considered subclinical, 11-20 associated with significant functional impairment but less severe clinical symptomology, and >20 suggest moderately severe functional impairment (Mundt et al. 2002)."},{"outcome_type":"secondary","measure":"Time Use Survey - Structured Hours (TUS-SH)","time_frame":"Measure completed in weeks 1, 5, 9, 13 and 17.","description":"Social recovery will be measured using an adapted versions of the Time Use Survey (TUS) Structured Hours, which has been previously validated for use as a social recovery measure by Hodgekins, Fowler and colleagues, and utilised in the National EDEN study (Hodgekins et al. 2015; Hodgekins 2012; Fowler et al. 2009). This will be adapted to a reduced interview to include only those areas relevant to the social recovery measure, hence the Time Use Survey-Structured Hours (TUS-SH)."},{"outcome_type":"secondary","measure":"Patient Health Questionnaire (PHQ-9)","time_frame":"Measure completed in weeks 1, 5, 9, 13 and 17.","description":"PHQ-9 is a self-administered measure of depression, which scores all 9 of the DSM-IV criteria for depression. Scores range from 0-27, with 5-9 indicating minimal symptoms, 10-14 minor depression, 15-19 moderately severe major depression and ≥20 severe major depression."},{"outcome_type":"secondary","measure":"Rapid Visual Information Processing (RVP) / CANTAB Cognitive Test","time_frame":"Measure completed in weeks 1, 5, 9, 13 and 17.","description":"iPad delivered cognitive test of sustained attention."},{"outcome_type":"secondary","measure":"Paired Associates Learning (PAL) / CANTAB Cognitive Test","time_frame":"Measure completed in weeks 1, 5, 9, 13 and 17.","description":"iPad delivered cognitive test of visual episodic memory."},{"outcome_type":"secondary","measure":"Spatial Working Memory (SWM) / CANTAB Cognitive Test","time_frame":"Measure completed in weeks 1, 5, 9, 13 and 17.","description":"iPad delivered cognitive test of working memory and strategy."},{"outcome_type":"secondary","measure":"Emotion Recognition Task (ERT) / CANTAB Cognitive Test","time_frame":"Measure completed in weeks 1, 5, 9, 13 and 17.","description":"iPad delivered cognitive test of emotional recognition."},{"outcome_type":"secondary","measure":"Global Assessment of Functioning (GAF) (split version / subscales GAF-D & GAF-S)","time_frame":"Measure completed in weeks 1, 9 and 17.","description":"GAF is an assessment of psychological, social and occupational functioning along a hypothetical continuum of mental health/illness. It is suggested that symptom scale for degree of severity be considered to cover the past 3 days prior to assessment but time frames can be varied based on the intention of use (Aas 2011). However by utilising the split version of this measure, the symptom and function scores can be evaluated and considered independently. This has been shown to be highly consistent across experienced raters, so sufficient training and utilisation may be fundamental to its efficacy (Pedersen et al. 2007). Scores range from 0-100 with higher scores representing better functioning across symptomatic and functional domains (Hall 1995)."},{"outcome_type":"secondary","measure":"Change from baseline Work and Social Adjustment Scale (WSAS) score at week 17","time_frame":"Measure completed at baseline (start of week 1) and week 17.","description":"WSAS is a simple and reliable measure of impaired functioning. Scores range from 0-40, with lower scores representing better functioning, scores 0-10 are considered subclinical, 11-20 associated with significant functional impairment but less severe clinical symptomology, and >20 suggest moderately severe functional impairment (Mundt et al. 2002)."},{"outcome_type":"secondary","measure":"Change from baseline Work and Social Adjustment Scale (WSAS) score at week 5, to correct for confounding in mediation analysis","time_frame":"Measure completed at baseline (start of week 1) and week 5.","description":"WSAS is a simple and reliable measure of impaired functioning. Scores range from 0-40, with lower scores representing better functioning, scores 0-10 are considered subclinical, 11-20 associated with significant functional impairment but less severe clinical symptomology, and >20 suggest moderately severe functional impairment (Mundt et al. 2002)."},{"outcome_type":"secondary","measure":"Change from baseline Work and Social Adjustment Scale (WSAS) score at week 13, to correct for confounding in mediation analysis","time_frame":"Measure completed at baseline (start of week 1) and week 13.","description":"WSAS is a simple and reliable measure of impaired functioning. Scores range from 0-40, with lower scores representing better functioning, scores 0-10 are considered subclinical, 11-20 associated with significant functional impairment but less severe clinical symptomology, and >20 suggest moderately severe functional impairment (Mundt et al. 2002)."},{"outcome_type":"other","measure":"Sleep Condition Indicator (SCI-8)","time_frame":"Measure completed in weeks 1, 5, 9, 13 and 17.","description":"SCI-8 this measure is validated against DSM-5 criteria for insomnia, including sleep quality and daytime function over the previous week. It is utilised within the Sleepio intervention and was the primary outcome measure for the OASIS randomised controlled trial (Freeman et al. 2017). This eight-item assessment questionnaire includes: 'concerns about getting to sleep, remaining asleep, sleep quality, daytime functioning, daytime performance, duration of sleep problem, nights per week having a sleep problem and extent troubled by poor sleep'(Espie, Kyle, Hames, et al. 2014). It has a robust internal consistency (α≥0.86) and showed convergent validity with the Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI) (Espie, Kyle, Hames, et al. 2014). Scores range from 0-32 with higher scores indicating better sleep, scores below 17 identifying insomnia in 89% of cases (Espie, Kyle, Hames, et al. 2014; Freeman et al. 2017)."},{"outcome_type":"other","measure":"Insomnia Severity Index (ISI)","time_frame":"Measure completed in weeks 1, 9 and 17.","description":"ISI is a measure specifically designed as a brief self-administered measure of insomnia and outcomes for use in their treatment within research. It corresponds to the DSM-IV criteria for insomnia and measures perception and severity of symptoms within the previous 2 weeks. Scores range from 0-28, 0-7 indicating no significant insomnia, 8-14 sub threshold insomnia, 15-21 moderate clinical insomnia, and 22-28 severe clinical insomnia (Smith & Wegener 2003; Bastien et al. 2001). It has been validated as a web-based measure with internal consistency of ≥88% (Thorndike et al. 2011)."},{"outcome_type":"other","measure":"Pittsburgh Sleep Quality Index (PSQI)","time_frame":"Measure completed in weeks 1, 9 and 17.","description":"PSQI is a self-report 19-item measure that retrospectively measures sleep quality and disturbances over the previous month. The domains of sleep quality included are: sleep wake patterns, duration of sleep, sleep latency, the frequency and severity of specific sleep-related problems and impact on daytime function. Scores range from 0-21, with higher scores indicating poorer sleep quality. The empirically derived cut-off score is >5 to distinguish poor sleepers with severe difficulties in at least 2 domains, or moderate difficulties in more than 3 domains. This cut-off correctly identifies 88.5% of patients, with a sensitivity of 89.6% and specificity of 86.5% (Buysse et al. 1989; Smith & Wegener 2003)."},{"outcome_type":"other","measure":"Validation of Sleep Diaries by comparison with actigraphy activity data","time_frame":"Monitoring will be done for a complete week just prior to week 1, during week 8 and 16. Sleep diaries are collected nightly during this same period.","description":"Nightly sleep diaries will be reported online using the Sleepio.com online diary.\r\nGENEActive actigraphy watch will collect raw data of activity. Which will record sleep patterns objectively. This will be compared with sleep diaries for consistency of subjective measure with objective measure.\r\nThe actigraphy data will be considered for L5 (lowest 5 hours of activity) M10 (highest 10 hours of activity) and relative amplitude (ratio between L5 and M10). This will then be compared with the nightly sleep diaries for the same period to determine percentage of consistency of reporting."},{"outcome_type":"other","measure":"COVID-19 Brief Questionnaire (COVID-19-B)","time_frame":"Measure completed in weeks 1, 5, 9, 13 and 17.","description":"This is a short 7 question (3 minute) survey to allow us to collect basic data on the impact of the ongoing pandemic on participants."}]}
{"nct_id":"NCT04448171","start_date":"2020-10-28","phase":"N/A","enrollment":60,"brief_title":"TENS Used for Pain Management During Office Cystoscopy Botox Injections","official_title":"Transcutaneous Electric Nerve Stimulation For Pain Control During Office Intra-detrusor Onabotulinumtoxin A Cystoscopy Injection for Overactive Bladder: A Phase III Randomized Controlled Trial","primary_completion_date":"2022-03-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-05-31","last_update":"2020-11-13","description":"The purpose of this study is to determine how Transcutaneous Electric Nerve Stimulation (TENS) units affects pain management during office cystoscopic Botox injections and patient satisfaction with the procedure .","other_id":"20-003510","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion:\r\n\r\n          -  Females age 18 years or older\r\n\r\n          -  Scheduled to receive intra-detrusor Onabotulinumtoxin-A injection for Overactive\r\n             Bladder in the outpatient clinic\r\n\r\n          -  Reads, speaks, and understands the English language\r\n\r\n          -  Able to understand the requirements of the study, including randomization\r\n\r\n          -  Willing and able to provide written informed consent\r\n\r\n        Exclusion:\r\n\r\n          -  Previous use of TENS therapy\r\n\r\n          -  Has a spouse or first degree relative who has previously used TENS therapy\r\n\r\n          -  Currently has an implanted pacemaker or automatic cardiac defibrillator\r\n\r\n          -  History of epilepsy\r\n\r\n          -  Currently pregnant or within 12 weeks postpartum\r\n\r\n          -  Unwilling to be randomized\r\n      ","sponsor":"Mayo Clinic","sponsor_type":"Other","conditions":"Overactive Bladder","interventions":[{"intervention_type":"Device","name":"Device: Sham TENS","description":"Standard TENS unit with four pads affixed to the lower back area, will be used in this arm. The TENS device will be set to an inactive setting."},{"intervention_type":"Device","name":"Device: Active TENS","description":"Standard TENS unit with four pads affixed to the lower back area, will be used in this arm. The TENS device will be set to an active setting."}],"outcomes":[{"outcome_type":"primary","measure":"Assess whether the TENS units is effective over standard pain control measures for intra-procedure pain management during office cystoscopic Intra-detrusor Onabotulinumtoxin A in women with OAB.","time_frame":"Baseline to intra-procedure","description":"Compare the change in participant-reported numerical pain score using a 0-10 numerical pain scale at baseline and intra-procedure."},{"outcome_type":"secondary","measure":"Evaluate the effect of TENS units on participant satisfaction following cystoscopic intra-detrusor onabotulinumtoxin A injection in women with OAB.","time_frame":"Postprocedure, 10 minutes following completion of cystoscopy","description":"Evaluate participant satisfaction using a 10 point Likert scale (1=complete dissatisfaction and 10=complete satisfaction)"}]}
{"nct_id":"NCT03837314","start_date":"2020-10-28","phase":"N/A","enrollment":25,"brief_title":"Simpler and Safer Deep Brain Stimulation for Parkinson's Disease","official_title":"Simpler and Safer Deep Brain Stimulation for Parkinson's Disease","primary_completion_date":"2022-11-01","study_type":"Interventional","rec_status":"Enrolling by invitation","completion_date":"2024-11-01","last_update":"2020-11-09","description":"The aim is to improve availability and acceptability of deep brain stimulation (DBS) for the treatment of Parkinson by shortening and simplifying the implantation procedure, thereby reducing time in surgery, complexity, post-surgery complications and cost, and increasing patient satisfaction. To facilitate the shortening and simplifying of the implantation procedure, a miniaturised skull-mounted DBS device (Picostim) has been developed which is optimised to generate waveforms needed for stimulation of the subthalamic nucleus (STN) and STN region, employing a unique method of controlling stimulation current. The planned study is a single centre, open label, non-randomised design with the primary objective of showing similarity in control of motor symptoms for the Picostim device compared with previously published data for existing DBS devices.","other_id":"3174","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":21,"population":"","criteria":"\n        Inclusion criteria:\r\n\r\n          -  Patients who report motor symptoms of Parkinson for at least 4 years;\r\n\r\n          -  Patients eligible for DBS Surgery;\r\n\r\n          -  Receiving stable medical therapy for 30 days or longer before screening assessments -\r\n             as reported by the patient;\r\n\r\n          -  Males and females aged 21 years or older;\r\n\r\n          -  Be willing and able to comply with all visits and study related procedures (e.g.,\r\n             using the remote control, charging systems and completing the motor diary);\r\n\r\n          -  Understands the study requirements and the treatment procedures and is able to provide\r\n             written informed consent;\r\n\r\n          -  Females of child-bearing potential must have a negative pregnancy test at study entry\r\n             and report using an effective method of contraception;\r\n\r\n        Exclusion criteria:\r\n\r\n          -  Atypical Parkinsonian (Parkinson-plus) syndromes;\r\n\r\n          -  Any prior movement disorder treatments that involved intracranial surgery or device\r\n             implantation;\r\n\r\n          -  Presence of or planned implant of any other active implanted device;\r\n\r\n          -  Surgical contraindications (such as issues preventing safe anaesthesia);\r\n\r\n          -  Contraindications for MRI scanning (such as presence of metal in the body which means\r\n             scanning may be harmful);\r\n\r\n          -  Active alcohol or drug abuse;\r\n\r\n          -  Dementia or any neuropsychological condition or finding that would contraindicate DBS\r\n             surgery. Mattis DRS-2 AEMSS of 6 or less;\r\n\r\n          -  Previous brain surgery likely to interfere with DBS implant;\r\n\r\n          -  Frequent falls when on adequate medication therapy in an \"on\" state, in the opinion of\r\n             the PI/delegated clinician;\r\n\r\n          -  A past or current psychiatric disturbance that in the opinion of the PI\r\n             contraindicates DBS surgery;\r\n\r\n          -  Use of anticoagulant medications that cannot be discontinued during perioperative\r\n             period;\r\n\r\n          -  Clinically problematic dopamine dysregulation syndrome in the opinion of the PI;\r\n\r\n          -  Significant medical condition that is likely to interfere with study procedures or\r\n             likely to confound evaluation of study endpoints, including any terminal illness with\r\n             expected survival of less than 5 years;\r\n\r\n          -  Participation in another trial concurrently or within 30 days preceding enrolment,\r\n             that is deemed to interfere with this trial;\r\n\r\n          -  Females who are pregnant, considering becoming pregnant during the study period, or\r\n             who are breastfeeding.\r\n      ","sponsor":"North Bristol NHS Trust","sponsor_type":"Other","conditions":"Parkinson's Disease","interventions":[{"intervention_type":"Device","name":"Device: Bioinduction \"Picostim\" Deep Brain Stimulation system","description":"Neurostimulation of the subthalamic nucleus region."}],"outcomes":[{"outcome_type":"secondary","measure":"Motor and cognitive functions","time_frame":"12, 26 and 52 weeks post device implantation.","description":"Assessment of change from baseline in L-dopa equivalent. Medication requirements at 12, 26 and 52 weeks post implantation. Range between 300 mg/day and 2000 mg/day, best outcome is lower consumption (300 mg/day)"},{"outcome_type":"primary","measure":"Change in motor function.","time_frame":"26 weeks","description":"Change in the Unified Parkinson's Disease Rating Scale (UPDRS) III score at 26 weeks post implantation with stimulation on without medication compared with baseline assessment (without medication). Standard range is from 0 to 108, lower score is better than higher score"},{"outcome_type":"primary","measure":"Collection and recording of adverse events","time_frame":"26 weeks","description":"Rate and type of adverse events including serious adverse events, procedure-related, device-related, stimulation-related, and other adverse events"},{"outcome_type":"secondary","measure":"Surgical time to complete procedure","time_frame":"12, 26 and 52 weeks intra-operative post device implantation.","description":"Surgical time to complete procedure. Range being between 2h and 2 days."},{"outcome_type":"secondary","measure":"Post-operation complications: % of patients with infections and pain at the implantation site","time_frame":"12 weeks","description":"% of patients with infections and pain at the implantation site"},{"outcome_type":"secondary","measure":"Tolerability and satisfaction with the head mounted device on a 1-10 range Patient satisfaction questionnaire","time_frame":"12, 26 and 52 weeks post device implantation.","description":"User assessment of the tolerability of the head mounted device and of the device's battery efficiency (length and frequency of charging, ease of use) for up to one year following surgery. Assessed through a 1-10 scale, 1 being the worst outcome, 10 the best outcome"},{"outcome_type":"secondary","measure":"Motor functions assessed through recording of motor fluctuation diary","time_frame":"12, 26 and 52 weeks post device implantation.","description":"Assessment of change from baseline in motor fluctuation diary recordings at 12, 26 and 52 weeks post implantation."},{"outcome_type":"secondary","measure":"Mentation, Behaviour and Mood assessed through standard UPDRS Test (see description)","time_frame":"12, 26 and 52 weeks post device implantation.","description":"Assessment of change from baseline in motor functions: Unified Parkinson's Disease Rating Scale (UPDRS) I score at 12, 26 and 52 weeks post implantation. UPDRS I score can vary between 0 and 16, 16 being the worst outcome and 0 the best outcome"},{"outcome_type":"secondary","measure":"Motor and cognitive functions assessed through standard Hoehn and Yahr test (see description)","time_frame":"12, 26 and 52 weeks post device implantation.","description":"Assessment of change from baseline in Hoehn and Yahr scores at 12, 26 and 52 weeks post implantation. Scale is between 1 to 5, best outcome being 1, worst outcome being 5"},{"outcome_type":"secondary","measure":"Non-Motor functions assessed through standard Dementia Rating Scale (see description)","time_frame":"12, 26 and 52 weeks post device implantation.","description":"Assessment of change from baseline in non-motor symptom scores at 12, 26 and 52 weeks post implantation. Dementia Rating scale 2 (DRS-2) score. Range from 0 to 144, 144 being the best outcome."},{"outcome_type":"secondary","measure":"Cognitive functions assessed through standard Beck Depression Inventory Test (see description)","time_frame":"12, 26 and 52 weeks post device implantation.","description":"Assessment of change from baseline in cognitive function and mood status scores at 12, 26 and 52 weeks post implantation. Beck Depression Inventory score, range from 0 to 63, 0 being the best outcome, 63 being the worst outcome"},{"outcome_type":"secondary","measure":"Quality of life assessed through standard Eq5D questionnaire (see description)","time_frame":"12, 26 and 52 weeks post device implantation.","description":"Assessment of change from baseline in quality of life measures at 12, 26 and 52 weeks post implantation. EuroQuality of Life score (Eq5D) score ranging from 5 to 15, 5 being the best outcome, 15 the worst."},{"outcome_type":"secondary","measure":"Activities in Daily Living assessed through standard UPDRS Test (see description)","time_frame":"12, 26 and 52 weeks post device implantation.","description":"Assessment of change from baseline in motor functions: Unified Parkinson's Disease Rating Scale (UPDRS) II on and off stimulation at 12, 26 and 52 weeks post implantation. Scores range from 0 to 52, 0 being the best outcome, 52 the worst outcome"},{"outcome_type":"secondary","measure":"Motor examinations assessed through standard UPDRS Test (see description)","time_frame":"12, 26 and 52 weeks post device implantation.","description":"Assessment of change from baseline in motor functions: Unified Parkinson's Disease Rating Scale (UPDRS) III score on medications at 12, 26 and 52 weeks post implantation. Scores range from 0 (best outcome) to 56 (worst outcome)"},{"outcome_type":"secondary","measure":"Complications of Therapy assessed through standard UPDRS Test (see description)","time_frame":"12, 26 and 52 weeks post device implantation.","description":"Assessment of change from baseline in motor functions: (Unified Parkinson's Disease Rating Scale) UPDRS IV score at 12, 26 and 52 weeks post implantation. Score range from 0 (best outcome) to 23 (worst outcome)"},{"outcome_type":"secondary","measure":"Safety data assessed through analysis of adverse events occurence","time_frame":"12, 26 and 52 weeks post device implantation.","description":"Collection and assessment of adverse events (procedure-related, device-related, stimulation-related, and other adverse events) throughout the trial. % of patients having device-related or procedure related adverse events."}]}
{"nct_id":"NCT04744402","start_date":"2020-10-28","phase":"Phase 2","enrollment":50,"brief_title":"Phase 2 Clinical Trial of CartiLife in the United States","official_title":"A Multi-Center, Active-Controlled, Open-Label, Phase 2 Trial to Compare the Efficacy and Safety of CartiLife, and Microfracture for Patients With Articular Cartilage Defects in the Knee","primary_completion_date":"2022-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-12-31","last_update":"2021-03-23","description":"To evaluate the safety and efficacy of implanting pellet-type extracellular matrix-associated autologous chondrocytes (CartiLife) obtained by cultivating costal chondrocytes of the subject with articular cartilage defects of the knee as a result of trauma or degeneration.","other_id":"BS-CTL-II","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Investigational group: CartiLife Extracellular matrix-associated autologous chondrocytes comprise CartiLife, composed as pellets (1.1 to 1.8 mm in diameter) in suspension. One pre-filled syringe is implanted per 1 cm3 of defect volume, and fibrin adhesive is applied to fix pellets in place through minimal arthrotomy.\r\nActive comparator: Microfracture surgery Microfracture surgery, performed by arthroscopy after the joint is cleaned of calcified cartilage, will be conducted using an awl or drill to create tiny fractures in the subchondral bone plate.","sampling_method":"","gender":"All","minimum_age":19,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        In order to be eligible to participate in this study, an individual must meet all of the\r\n        following:\r\n\r\n          1. Male or female subjects aged over 18 at the time of signing the Informed Consent form\r\n\r\n          2. Subject who has a size of the relevant cartilage lesion  2 cm2 and  10 cm2 but with\r\n             a defect area total volume  4 cm3\r\n\r\n          3. Subject with isolated International Cartilage Repair Society (ICRS) Grade III or IV\r\n             chondral lesion on articular cartilage\r\n\r\n          4. Subject who has a lower extremity alignment within 5 degrees of the neutral weight\r\n             bearing axis\r\n\r\n          5. Subject who can move independently and has a mechanically stable knee (normal ligament\r\n             status)\r\n\r\n          6. Subject with intact or partial meniscus status (>50% of meniscus)\r\n\r\n          7. Subject who has KOOS pain value less than 55 at baseline\r\n\r\n          8. Subject who agrees to actively participate in a rehabilitation protocol and follow-up\r\n             program\r\n\r\n          9. Subject who is able to provide informed consent and comply with study requirements\r\n\r\n         10. Subject who is willing to discontinue any nonsteroidal anti-inflammatory drugs\r\n             (NSAIDs) except rescue medication (< acetaminophen 4 g per day) 7 days prior to visit\r\n\r\n         11. Subject who has Body Mass Index (BMI)  35 kg/m2\r\n\r\n         12. Female and male subjects of childbearing potential who are willing to use adequate\r\n             contraception methods for the duration of the trial.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Individuals who meet any of the following will be excluded from participation in this\r\n        study:\r\n\r\n          1. Subject who has inflammatory articular diseases such as rheumatoid arthritis or gout\r\n             or pseudogout\r\n\r\n          2. Subject who has radiographic evidence of grade 4 osteoarthritis based on the Kellgren\r\n             and Lawrence criteria\r\n\r\n          3. Subject who has received an intra-articular treatment within the last 3 months\r\n\r\n          4. Subject who has had a surgical procedure on the knees within the last 2 months\r\n\r\n          5. Subject who has a condition in another lower extremity joint that interferes with the\r\n             function of the index knee\r\n\r\n          6. Subject who would receive a concomitant surgical procedure on the knees at the time of\r\n             the study treatment\r\n\r\n          7. Subject whose articular cartilage defect is asymptomatic\r\n\r\n          8. Subject who has any clinically significant disease, which is judged by the\r\n             investigator to affect this clinical trial, including but not limited to diabetes not\r\n             adequately controlled, bleeding diathesis or hematologic disease, endocrinopathies,\r\n             cardiovascular disease, renal disease (severe renal impairment), autoimmune disease,\r\n             inflammatory arthritis, and current infectious disease\r\n\r\n          9. Subject with other diseases including tumors except for cartilaginous defects of\r\n             joints\r\n\r\n         10. Subject who has a history of hypersensitivity to gentamicin, other aminoglycosides, or\r\n             products of porcine or bovine origin\r\n\r\n         11. Subject who participates in concurrent trials or in previous trial within 30 days of\r\n             signing informed consent\r\n\r\n         12. Subject who has any radiation therapy or chemotherapy within 2 years prior to\r\n             screening\r\n\r\n         13. Subject who is currently pregnant or nursing\r\n\r\n         14. Subject who has any degenerative muscular, connective tissue or neurological condition\r\n             or other disease process that would interfere with healing or the evaluation of\r\n             outcome measures.\r\n\r\n         15. Subject with known HIV infection, active hepatitis C and/or hepatitis B infection\r\n\r\n         16. Subject who has ligament instability > Grade 1\r\n\r\n         17. Subject who is an active drug/alcohol abuser or has a history of alcohol or drug abuse\r\n             during the last two years.\r\n\r\n         18. Subject who has significant lab abnormalities for the following parameters (If the\r\n             value is within 10% of the listed laboratory exclusion criterion value and the value\r\n             is considered not to be clinically significant by the investigator, the subject can be\r\n             considered for enrollment):\r\n\r\n               -  Serum ALT and AST > 3 x upper limit of normal\r\n\r\n               -  Serum creatinine > 1.5 x upper limit of normal\r\n\r\n               -  PT/INR out of normal range\r\n\r\n               -  Hemoglobin < 10 g/dL for female subject and hemoglobin < 11 g/dL for male subject\r\n\r\n               -  Platelets out of normal range\r\n\r\n               -  Hemoglobin A1c levels > 9%\r\n      ","sponsor":"Biosolution Co., Ltd.","sponsor_type":"Industry","conditions":"Articular Cartilage Defect|Articular Cartilage Degeneration","interventions":[{"intervention_type":"Drug","name":"Drug: Autologous Chondrocyte Implantation (CartiLife)","description":"CartiLife consists of small beads (1 mm in diameter) in suspension, developed from pellet culture of autologous costal chondrocytes after multiplication. The beads are implanted in an injective manner with fibrin glue through minimal arthrotomy. The dose depends on the size (volume) of the defect, recommended dose is 480 pellets/cm^3 defect"},{"intervention_type":"Procedure","name":"Procedure: Microfracture Surgery","description":"Microfracture surgery, performed by arthroscopy after the joint is cleaned of calcified cartilage, will be conducted using an awl or drill to create tiny fractures in the subchondral bone plate."}],"outcomes":[{"outcome_type":"primary","measure":"Change in KOOS (Knee Injury and Osteoarthritis Outcome Score) function (sports and recreational activities)","time_frame":"Week 0 (pre-operation) to Week 48 (post-operation)","description":"The KOOS (Knee Injury and Osteoarthritis Outcome Score) is a reliable and valid patient-reported outcome measurement tool that evaluates both short-term and long-term consequences of knee injury. The 5 separately scored subscales of Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related QOL may enrich clinical and research data interpretation (Roos and Lohmander, 2003; Collins et al, 2011). The score ranges from 0 to 100, with 0 representing extreme problems and 100 representing no problems."},{"outcome_type":"primary","measure":"Change in volume fill of cartilage defect score","time_frame":"Week 0 (pre-operation) to Week 48 (post-operation)","description":"Volume fill of cartilage defect score from MOCART 2.0 Criteria (Schreiner, et al, 2019). The score is from 0 to 20, with 0 representing \"<25% filling of total defect volume OR complete delamination in situ\" and 20 representing \"Complete fill OR minor hypertrophy (100% to 150% filling of total defect volume)."},{"outcome_type":"secondary","measure":"Change in Lysholm Score","time_frame":"Week 0 (pre-operation) to Week 8, 24 and 48 (post-operation)","description":"The Lysholm scale is a broadly applicable, validated tool for measuring changes following nonsurgical and surgical intervention, as well as deterioration over time in patients with various knee pathologies (Collins et al, 2011). The score is from 0 to 100, with 0 representing extreme problems and 100 representing no problems."},{"outcome_type":"secondary","measure":"Change in IKDC (International Knee Documentation Committee) Score","time_frame":"Week 0 (pre-operation) to Week 8, 24 and 48 (post-operation)","description":"The IKDC (International Knee Documentation Committee) Knee form covers domains likely to be important to patients and has adequate consistency and broad applicability across mixed groups of patients (Collins et al, 2011). The score is from 0 to 100, with 0 representing extreme problems and 100 representing no problems."},{"outcome_type":"secondary","measure":"Change in KOOS (Knee injury Osteoarthritis Outcome Score) subscale scores (Pain, Other symptoms, Function in daily living, and knee-related Quality of Life)","time_frame":"Week 0 (pre-operation) to Week 8, 24 and 48 (post-operation)","description":"The KOOS (Knee injury Osteoarthritis Outcome Score) is a reliable and valid patient-reported outcome measurement tool that evaluates both short-term and long-term consequences of knee injury. The 5 separately scored subscales of Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related QOL may enrich clinical and research data interpretation (Roos and Lohmander, 2003; Collins et al, 2011). The score is from 0 to 100, with 0 representing extreme problems and 100 representing no problems."},{"outcome_type":"secondary","measure":"Change in KOOS (Knee injury Osteoarthritis Outcome Score) Total Score","time_frame":"Week 0 (pre-operation) to Week 8, 24 and 48 (post-operation)","description":"The KOOS is a reliable and valid patient-reported outcome measurement tool that evaluates both short-term and long-term consequences of knee injury. The 5 separately scored subscales of Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related QOL may enrich clinical and research data interpretation (Roos and Lohmander, 2003; Collins et al, 2011). The score is from 0 to 100, with 0 representing extreme problems and 100 representing no problems."},{"outcome_type":"secondary","measure":"Change in VAS (100mm Pain Visual Analogue Scale)","time_frame":"Week 0 (pre-operation) to Week 8, 24 and 48 (post-operation)","description":"The VAS is a validated, ubiquitous tool for patient-reported measurement of pain at a given point in time (Kersten et al, 2014). The score is from 0 to 100, with 0 representing no pain and 100 representing extreme pain."},{"outcome_type":"secondary","measure":"Change in Tegner Activity Score","time_frame":"Week 0 (pre-operation) to Week 8, 24 and 48 (post-operation)","description":"The Tegner activity score is a frequently used patient-administered activity rating system for patients with various knee activity functions. The instrument scores a person's activity level between 0 and 10 where 0 is 'on sick leave/disability' and 10 is 'participation in competitive sports such as soccer at a national or international elite level' (Karen Hambly, 2011)."},{"outcome_type":"secondary","measure":"Change in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Score","time_frame":"Week 0 (pre-operation) to Week 8, 24 and 48 (post-operation)","description":"The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints (Jose M. 2006). The score is from 0 to 100, with 0 representing no problems and 100 representing extreme problems."},{"outcome_type":"secondary","measure":"Evaluations of MOCART Score","time_frame":"Week 24 and 48 (post-operation)","description":"MOCART provides a reliable, reproducible, and accurate method of assessment of cartilage repair tissue. The total score is determined by adding the following subscale scores :\r\nVolume fill of cartilage defect (0~20 points, 20:Complete filling, 0:<25% filling of total defect volume)\r\nIntegration into adjacent cartilage (0~15 points, 15:Complete integration, 0:Integrated cartilage interface ≥50% of repair tissue length)\r\nSurface of the repair tissue (0~10 points, 10:Surface intact, 0:≥50% surface irregularity)\r\nStructure of the repair tissue (0~10 points, 10:Homogenous, 0:Inhomogenous)\r\nSignal intensity of the repair tissue (0~15 points, 15:Normal, 0:Severely abnormal)\r\nBony defect or bony overgrowth (0~10 points, 10:No bony defect or overgrowth, 0:Bony defect, depth ≥ thickness or overgrowth ≥50% of adjacent cartilage)\r\nSubchondral changes (0 ~ 20 points, 20:No major changes, 0:Subchondral cyst ≥5 mm in longest diameter OR osteonecrosis-like signal)"},{"outcome_type":"secondary","measure":"Evaluation of T2 mapping","time_frame":"Week 24 and 48 (post-operation)","description":"In vivo, the visualization of collagen architecture, and possibly the maturation of this architecture over time in cartilage repair tissue, can be seen when assessing the spatial variation of T2 values. Histologically validated animal studies report this increase in zonal T2 as an indicator of hyaline or ''hyaline-like'' cartilage composition. T2 evaluation is more sensitive in revealing changes in articular cartilage and cartilage repair tissue compared to morphological analysis using thickness measurements or the MOCART score. (Mamisch et al, 2010)"},{"outcome_type":"secondary","measure":"Change in pain medication dosage","time_frame":"Week 0 (pre-operation) to Week 8, 24 and 48 (post-operation)","description":"Pain medication history is an indicator of patient pain. The amount of analgesic ingestion is measured for the specified duration over the course of the clinical trial, and changes in analgesic ingestion are assessed to analyze the efficacy of the clinical trial product."},{"outcome_type":"secondary","measure":"Change in pain medication frequency","time_frame":"Week 0 (pre-operation) to Week 8, 24 and 48 (post-operation)","description":"Pain medication history is an indicator of patient pain. The frequency of analgesic ingestion is measured for the specified duration over the course of the clinical trial, and changes in analgesic ingestion in terms of frequency are assessed to analyze the efficacy of the clinical trial product."},{"outcome_type":"secondary","measure":"Number of subjects with treatment-related adverse events","time_frame":"Week 0 (pre-operation), and up to 24 Months (post-operation)","description":"Number of subjects with treatment related adverse events as assessed by analysis of adverse events including symptoms, and abnormal findings on physical examination, vital signs, ECG, and standard laboratory examination results"},{"outcome_type":"secondary","measure":"Number of subjects with treatment-emergent serious adverse events","time_frame":"Week 0 (pre-operation), and up to 24 Months (post-operation)","description":"Number of subjects with treatment-emergent serious adverse events defined as one or more of the following untoward medical occurrences happening during study period.\r\nLife-threatening event (e.g., stroke or non-fatal pulmonary embolism).\r\nRequires inpatient hospitalization or prolongation of existing hospitalization.\r\nResults in persistent or significant disability/incapacity.\r\nResults in death.\r\nLeads to other clinically significant untoward laboratory test result(s) or medical condition(s), determined per Investigator's judgement."}]}
{"nct_id":"NCT04179305","start_date":"2020-10-25","phase":"N/A","enrollment":58,"brief_title":"Giving Information Systematically and Transparently in Lung and GI Cancer Phase 2","official_title":"Giving Information Systematically and Transparently in Lung and GI Cancer Phase 2","primary_completion_date":"2022-06-25","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-07-25","last_update":"2021-09-01","description":"When advanced disease progresses, there comes a time when an oncologists must explain to their patients that they only have months left to live. During these discussions the oncologist attempts to explain to the patient their prognoses and what it means for them going forward. However our prior studies shown that even when patients only have months left to live, most do not understand that their cancer is incurable and that it is late/end-stage. Dying cancer patients who fully understand their prognosis are able to make more informed decisions and are therefore more likely to engage in advanced care planning, and receive care what in consistent with their values and preferences. They are also in a better position to avoid burdensome, non-beneficial care. The investigator developed Oncolo-GIST in order to help increase the number of patients who fully understand their prognosis and its implications. Oncolo-GIST is an intervention aimed at enhancing clinicians' communication with patients by teaching them to relay information both sensitively and using simple terminology. The Oncolo-GIST training will provide instruction in areas such as how to introduce the topic of prognosis (describe scan results as \"worse\"), how to phrase the prognosis itself (\"likely months, not years\"), how to explain expected treatment outcomes (e.g., \"not expected to be cured by treatment\") and how to describe expected treatments impact on quality of life - that is, whether the anticancer treatment is likely to make them feel overall better or worse. The training materials consist of a manual and a set of videos that act out situations described in the manual. The second phase of this study will be a randomized controlled trial. The investigator will recruit (n=50) adults with metastatic GI or lung cancers with scan results that reveal progression (worsened disease) on an initial systemic treatment; that is, patients whose life-expectancy can reliably be estimated to be months, not years. Medical oncologists (n=8) who care for these patients will also be consented for study participation and half (n=4) will be randomized to receive the Oncolo-GIST training. Patients will be assessed by trained research staff in the week prior to a scheduled meeting with their oncologist to discuss the scan results. This will provide patients' baseline levels of prognostic understanding and enable the investigator to determine how the intervention relates to pre-post scan visit changes in prognostic understanding. Patients will be assessed post-scan within a week of that progressive scan visit and then 2 and 4 months later. The assessment battery that will be administered at these time-points will measure the patient's degree of prognostic understanding, the primary outcome of the study. Other outcomes that will be measured by the assessment battery include the patients quality of life, therapeutic alliances of the patient, whether or not a DNR was ordered, the care received by the patient, whether or not the patient preferred greater quality of longer quantity of life, and whether or not the patients received \"value-consistent\" care.","other_id":"19-07020392-Phase2","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"Single","intervention_model_description":"Randomized controlled trial","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Clinicians\r\n\r\n        Inclusion Criteria:\r\n\r\n          -  Specialize in Lung and GI cancers\r\n\r\n          -  Currently provide care at the WCM Lung and GI cancer clinics\r\n\r\n          -  Fluent in English\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Does not specialize in Lung and GI cancers\r\n\r\n          -  Does not currently provide care at the WCM Lung and GI cancer clinics\r\n\r\n          -  Not fluent in English\r\n\r\n        Patients\r\n\r\n        Inclusion Criteria:\r\n\r\n          -  Receiving ongoing care ( 2 visits) that includes regular scans\r\n\r\n          -  Progression on at least 1 line of systemic cancer therapy\r\n\r\n          -  Prognosis from an oncologist of less than 12 months\r\n\r\n          -  Receiving care from an oncologist participating in the Oncolo-GIST study\r\n\r\n          -  Fluent in English\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Does not specialize in Lung and GI cancers\r\n\r\n          -  Does not currently provide care at the WCM Lung and GI cancer clinics\r\n\r\n          -  Not fluent in English\r\n      ","sponsor":"Weill Medical College of Cornell University","sponsor_type":"Other","conditions":"Critical Illness|Oncology|Communication","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Oncolo-GIST","description":"Behavioral: Oncolo-GIST Oncolo-GIST is a brief, manualized communication intervention that guides oncologists in \"gist communication\" by itemizing 4 key steps in the process of imparting prognostic information.\r\nTopic covered include:\r\nPrinciples of introducing prognosis in the setting of worsened scan results Coupling communicating realistic prognoses with psychological support (e.g., saying \"average life-expectancy is months\" with emphasizing that the oncology team \"will always provide care for you\") Addressing informational needs and psychological reactions Applying proven techniques for supporting patients who are reluctant to discuss prognosis.\r\nThe 4-step guide will include brief video-clips of demonstrating each \"talking point\" with a standardized patient, including ideal scenarios, common pitfalls to avoid, and how to respond to patient reactions that are particularly challenging, such as responding to optimism, death anxiety, and reliance on faith."},{"intervention_type":"Behavioral","name":"Behavioral: Usual Care Arm","description":"Oncologists will provide care in non-specific manner."}],"outcomes":[{"outcome_type":"primary","measure":"Change in Prognostic Understanding","time_frame":"Day 1, within one week, 2 months, 4 month","description":"Changes in illness understanding by patients as measured by the investigator's validated 4-item assessment will be compared between groups at one-week, two-month and 4-month follow up assessments (T2, T3, and T4). The assessment asks four questions that assess patients' terminal illness acknowledgment (TIA), recognition of their incurable disease status, knowledge of the advanced stage of their disease, and expectation to live months as opposed to years. Responses are coded 1 or 0 to indicate the presence or absence of each of these element. These four indicators are then added together to construct summary scores (possible range, 0 to 4). Differences between pre- and post-scan visit illness understanding scores (possible range, -4 to 4) are used to define changes in illness understanding by a patient between the pre- and post-scan visit interviews. Higher total scores represent an increase in prognostic understanding. Lower scores represent a decrease in understanding."},{"outcome_type":"secondary","measure":"Patient Quality of Life","time_frame":"Day 1, within one week, 2 months, 4 month","description":"Quality of life of patients, as measured by the McGill Quality of Life Questionnaire, will be compared between groups at one-week, two-month and 4-month follow up assessments (T2, T3, and T4). This questionnaire contains 16 items and each item uses a 10-point scale, where 0 is desirable and 10 is undesirable. Separate sub-scales scoring for global, physical, psychological, emotional and existential well-being, are determined by taking the mean of the associated items. The score for overall quality of life is determined by taking the mean of all the sub-scales. Higher total scores represent better quality of life. Lower scores represent worse better quality of life."},{"outcome_type":"secondary","measure":"Whether or not a Do Not Resuscitate was ordered by patient","time_frame":"2 months, 4 months","description":"Whether or not a Do Not Resuscitate (DNR) was ordered by the patient, as determined by a medical chart abstraction, will be compared between groups at 2-month and 4-month follow up assessments (T4). This will be scored as either a 0, if there was no DNR ordered, or a 1 if there was a DNR ordered."},{"outcome_type":"secondary","measure":"Treatment and Care Received","time_frame":"2 months, 4 months","description":"Methods of treatment and care received by patients, as determined from a medical chart abstraction, will be compared between groups at 2-month and 4-month follow up assessments (T4). Types of care include palliative care, hospice and hospitalization. Types of treatment include chemotherapy drugs, narcotic pain medication and radiation therapy."},{"outcome_type":"secondary","measure":"Patient Performance Status","time_frame":"2 months, 4 months","description":"Patients' performance status at 2 and 4 months post-scan will be measured on the Eastern Cooperative Cancer Group (ECOG) scale. Performance status includes the ability to maintain pre-illness levels of physical activity, capacity for routine tasks and self-care, and level of mobility. The ECOG scale ranges from 0 to 5: a patient with a score of 0 is active at pre-illness levels, while a patient with a score of 3 is mostly confined to bed or a chair with limited ability to care for themselves; a score of 5 indicates the patient is dead."}]}
{"nct_id":"NCT04721041","start_date":"2020-10-16","phase":"N/A","enrollment":40,"brief_title":"Washed Microbiota Transplantation for The Treatment of Oncotherapy-Related Intestinal Complications","official_title":"Efficacy and Safety of Washed Microbiota Transplantation for The Treatment of Oncotherapy-Related Intestinal Complications","primary_completion_date":"2022-10-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-10-31","last_update":"2021-01-22","description":"Gut microbiota, known as \"unrecognized organs\", is closely related to the occurrence and development of tumors. Cancer is thought to occur secondary to local chronic inflammation. And some bacteria, such as Helicobacter pylori, also have direct genotoxicity, changing intracellular signaling pathways and thus causing abnormal cell growth. Systemic intestinal dysbiosis may lead to cancer, and fecal microbiota transplantation (FMT) can be a new weapon in anti-cancer treatment.Washed microbiota transplantation (WMT), a new stage of FMT, is based on the automatic microfiltration machine (GenFMTer, Nanjing, China) and the following repeated centrifugation plus suspension with support from specific facilities.we conducted a prospective, one-arm, open-label study on the efficacy and safety of WMT in the treatment of oncotherapy-related complications. This study aimed to exploring the therapeutic potential of WMT in the treatment of oncotherapy-related intestinal complications and improving the quality of life of patients.","other_id":"Cancer-CN-202010","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  1. Age 18 years old; 2. Diagnosed as malignant tumor; 3. Patients who underwent\r\n             cancer-related treatment suffering from gastrointestinal symptoms(e.g., abdominal\r\n             pain, diarrhea, abdominal distension, and difficulty defecating) occurred after\r\n             standard tumor therapy (such as chemotherapy, radiation, immunotherapy, surgical\r\n             treatment, etc.); 4. Estimated time of survival  3 months, and vital signs were\r\n             stable); 5. Physically qualified and intended to undergo FMT;\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  1. Patients who were pregnant or nursing; 2. Patients who were unable or unwilling to\r\n             undergo a gastroscopy or colonoscopy; 3. Patients with cardiopulmonary failure; 4.\r\n             Antibiotics, PPI, probiotics, and other drugs that alter gut microbiota were used in\r\n             the previous week; 5. history of inflammatory bowel disease and intestinal symptoms\r\n             unrelated to tumor treatment; 6.Serious uncontrolled diseases and acute infectious\r\n             diseases\r\n      ","sponsor":"The Second Hospital of Nanjing Medical University","sponsor_type":"Other","conditions":"Intestinal Complications|Cancer","interventions":[{"intervention_type":"Procedure","name":"Procedure: Washed Microbiota Transplantation (WMT)","description":"Washed microbiota suspension (5u) delivered through nasogastric tube, nasojejunal tube or oral. Dose and frequency: 5u, three times."}],"outcomes":[{"outcome_type":"primary","measure":"Scores of gastrointestinal symptoms","time_frame":"8 weeks","description":"Gastrointestinal symptoms will be evaluated according to NCI-CTC 5.0"},{"outcome_type":"primary","measure":"Stool frequency and consistency","time_frame":"8 weeks","description":"Stool frequency and consistency will be evaluated according to The Bristol Stool Form Scale (BSFS)."},{"outcome_type":"secondary","measure":"Adverse events","time_frame":"1 year","description":"New onset of symptoms and the exacerbation of previous symptoms were recorded as adverse events (AEs)"},{"outcome_type":"secondary","measure":"Karnofsky Performance Status (KPS) scale","time_frame":"8 weeks","description":"Changes in functional status of patients will be assessed according to the Karnofsky Performance Status (KPS) scale (ranging from 0 [dead] to 100 [normal activity, no evidence of disease])"}]}
{"nct_id":"NCT04750824","start_date":"2020-10-15","enrollment":201,"brief_title":"Real-World Effectiveness of Afatinib (Gilotrif) Following Immunotherapy in the Treatment of Metastatic, Squamous Cell Carcinoma of the Lung: A Multi-Site Retrospective Chart Review Study in the U.S.","official_title":"Assessment of Real-World Outcomes Associated With Afatinib (Gilotrif) Use in Patients With Solid Tumors Harboring NRG1 Gene Fusions","primary_completion_date":"2021-01-04","study_type":"Observational","rec_status":"Completed","completion_date":"2021-01-04","last_update":"2021-03-09","description":"Characteristics of patients with Neuregulin-1 (NRG1) gene fusion-positive solid tumors treated with afatinib, and characteristics of those treated with another systemic therapy.","other_id":"1200-0335","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Providers will select patients meeting the study eligibility criteria as described below.\r\n        Providers will be asked to select eligible patients chronologically, starting with the\r\n        first patient who first initiated any line of afatinib or chemotherapy, on or after\r\n        01/01/2017 through 03/31/2020.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adults, 18 years of age or older, at the time of diagnosis with any solid tumor.\r\n\r\n          -  Confirmed NRG1 gene fusion in any solid tumor.\r\n\r\n          -  Initiated afatinib or other systemic therapy (in any line of therapy) for treatment of\r\n             a solid tumor with NRG1 gene fusion on or after 01/01/2017 through 03/31/2020.\r\n\r\n          -  Followed up for 3 months after initiation of afatinib or other systemic therapy\r\n             (unless deceased prior to 3 months of follow-up).\r\n\r\n        Exclusion Criteria:\r\n\r\n        - Treatment with any Tyrosine kinase inhibitor (TKI)/ErbB-directed therapy other than\r\n        afatinib\r\n      ","sponsor":"Boehringer Ingelheim","sponsor_type":"Industry","conditions":"Non-squamous, Non-Small Cell Lung Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Afatinib","description":"Afatinib"},{"intervention_type":"Drug","name":"Drug: other systemic therapy","description":"other systemic therapy"}],"outcomes":[{"outcome_type":"primary","measure":"Proportion of patients with a complete response (CR) or partial response (PR)","time_frame":"1 day","description":"out of all patients (CR+PR/all patients) at initial response assessment and best response"},{"outcome_type":"secondary","measure":"Duration of clinical benefit (DOCB)","time_frame":"1 day","description":"time from initial response (for any patient with a complete, partial, or stable disease response initially) until the earliest of either disease progression or death"},{"outcome_type":"secondary","measure":"Duration of response","time_frame":"1 day","description":"time from initial response (for any patient with a complete or partial response initially) until the earliest of either disease progression or death"},{"outcome_type":"secondary","measure":"Time from initiation of a line of therapy until discontinuation for any reason","time_frame":"1 day"},{"outcome_type":"secondary","measure":"Time from initiation of a line of therapy until discontinuation due to disease progression","time_frame":"1 day"},{"outcome_type":"secondary","measure":"Time from initiation of a line of therapy until disease progression or death","time_frame":"1 day"},{"outcome_type":"secondary","measure":"Time from initiation of any therapy in the metastatic setting until death","time_frame":"1 day"},{"outcome_type":"secondary","measure":"Number of patients experiencing an adverse event","time_frame":"1 day"}]}
{"nct_id":"NCT04480749","start_date":"2020-10-14","phase":"Phase 4","enrollment":100,"brief_title":"Syphilis Self-testing to Expand Test Uptake Among Men Who Have Sex With Men (SST)","official_title":"Syphilis Self-testing to Expand Test Uptake Among Men Who Have Sex With Men (SST)","primary_completion_date":"2021-07-01","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2021-12-31","last_update":"2021-09-01","description":"Syphilis infection is a major global health problem, leading to substantial morbidity among key populations in low- and middle-income countries (LMICs). Men who have sex with men (MSM) are disproportionately affected by syphilis worldwide. Rates of syphilis diagnoses have been increasing amongst MSM in many countries in the last decade. A growing evidence base supporting HIV self-testing shows that self-testing kits based on the same proposed clinical pathways are feasible and reliable. The proposed study will leverage this body of evidence and apply it to syphilis self-testing. This is a pilot study conducted in Zimbabwe. It aims to collect initial data on the feasability of implementing syphilis self-testing to establish if a large scale-RCT of this approach would be appropriate and, if so, to inform the design of this trial. The investigators will recruit 100 MSM in Harare to join the pilot program. Participants will be recruited through two methods: in-person at MSM community-based organizations that currently operate HIV self-testing programs and online through banner advertisements that advertise HIV self-testing. Study Arms: Arm 1: One arm of the pilot will receive a free syphilis self-test kit (Intervention Arm) Arm 2: One arm will receive standard free facility-based syphilis testing (Control Arm). Intervention: In the intervention arm the investigators will provide a treponemal rapid syphilis test kit to all participants in the intervention arm of the pilot, delivered through MSM community facilitators. This is similar to existing rapid treponemal test kits that are available at many clinical facilities. Kits will be accompanied by simplified pictorial instructions on finger prick blood sample collection. Among participants in the control group, they will receive a list of local clinics that can provide free syphilis testing. Data Collection: For individuals in the intervention am the investigators will aim to obtain confirmation of test uptake. This will be done using either photographic confirmation sent via encrypted message on a smartphone, SMS message of a unique code or sending a unique five-digit code along with their test result to the study coordinator. The investigators will conduct cross-sectional surveys at baseline and six months later to assess sexual risk behaviours, HIV and syphilis testing experiences, and self-testing experiences. In addition to the survey data tool the investigators will conduct in-depth interviews with a small number of participants to gain additional data about their experience of syphilis self-testing. The investigators will obtain information on linkage to care from routine clinic administrative records and by providing study participants with a unique code to be provided when attending at the facility. Analysis: The investigators will used mixed-methods to evaluate our pilot intervention including The investigators will examine the proportion of individuals who undertake a syphilis test in the interventional and control arms; among those who receive a test, the proportion of individuals who receive appropriate post-testing services. The investigators will also collect qualitative data on attitudes to syphilis self-testing and quantitative data on syphilis prevalence to inform a subsequent clinical trial.","other_id":"17848","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Men who have sex with men\r\n\r\n          -  Able to consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Unable to consent\r\n      ","sponsor":"London School of Hygiene and Tropical Medicine","sponsor_type":"Other","conditions":"Syphilis","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Access to Facility based Syphilis Testing","description":"List of facilities where syphilis testing can be accessed"},{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Syphilis Self-Test","description":"Rapid Treponemal Test kit"}],"outcomes":[{"outcome_type":"primary","measure":"Syphilis tests undertaken","time_frame":"6 months","description":"The total number of syphilis undertaken by each participant at a health facility or through self-testing"}]}
{"nct_id":"NCT04295928","start_date":"2020-10-12","phase":"N/A","enrollment":1716,"brief_title":"Establishment of a Personalized Pharmaceutical Plan in Renal or Hepatic Transplant Patients","official_title":"Mise en Place d'un Plan Pharmaceutique Personnalis Chez Les Patients transplants rnaux ou hpatiques : Essai randomis en Cluster de Type Stepped-wedge.","primary_completion_date":"2022-09-11","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2025-09-11","last_update":"2021-08-24","description":"The main objective of the study is to evaluate the impact of the Personalized Pharmaceutical Plan on the therapeutic adherence to immunosuppressive treatments one year after liver or kidney transplantation.","other_id":"DR190061-GREPH","allocation":"Non-Randomized","intervention_model":"Sequential Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","intervention_model_description":"Cluster Stepped-wedge; Inclusions per cluster: Control period->Leeadin period->Interventionnal period","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patient  18 years old\r\n\r\n          -  Patient having given his free, informed and express consent\r\n\r\n          -  Patient with a kidney or liver transplantation performed in the 10 participating\r\n             university hospital centers\r\n\r\n          -  Patient speaking french\r\n\r\n          -  Patient whose main residence is in France and has no project of moving during the\r\n             study period\r\n\r\n          -  Patient declaring to attend the same pharmacy\r\n\r\n          -  Social insured patient\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patient protected: safeguard of justice, curatorship, tutelage\r\n\r\n          -  Patient having a double liver / kidney transplantation with a center not participating\r\n             in the study\r\n\r\n          -  Patients with a double organ transplantation kidney /hart\r\n\r\n          -  Patient already transplanted regardless of the organ\r\n      ","sponsor":"University Hospital, Tours","sponsor_type":"Other","conditions":"Personalized Pharmaceutical Plan After Transpantation","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: PPP","description":"Personalized Pharmaceutical Plan on therapeutic adherence to immunosuppressive treatments after the transplantation"}],"outcomes":[{"outcome_type":"primary","measure":"Therapeutic adhesion","time_frame":"1 year after transplantation","description":"The Investigator will consider that a patient is in therapeutic adhesion thanks to two methods : use of the BAASIS® questionnaire (if answer <1 for at least one of the 4 questions in the score, the patient will be considered as a non-adherent) and use of the health insurance data from the national health data system (checking that 100% of the days are covered by possession of immunosuppressive drugs)"},{"outcome_type":"secondary","measure":"Drug adherence of all chronic treatments prescribed to the patient (except immunosuppression (IS) drug)","time_frame":"1 year after transplantation","description":"Drug adherence of all chronic treatments prescribed to the patient (except immunosuppression (IS) drug) measured by the EvalObs® scale (graduation from 0 to 15)"},{"outcome_type":"secondary","measure":"Knowledge of hygienic-dietetic rules and drug intake modalities","time_frame":"1 year after transplantation","description":"Knowledge of hygienic-dietetic rules and drug intake modalities assessed using an questionnaire ( scale from 1-9)"},{"outcome_type":"secondary","measure":"Occurrence of adverse effects","time_frame":"At month 1,month 3, and 12 months after transplantation","description":"Search for the occurrence of adverse events related to IS (diabetes, hypertension, weight gain, tremor, leukopenia, thrombocytopenia,...) during medical and pharmaceutical consultations."},{"outcome_type":"secondary","measure":"Fate of the graft","time_frame":"1 year and 3 years after transplantation","description":"Study of the fate of the graft (rejection, rejection episodes)"},{"outcome_type":"secondary","measure":"Assessing patient, medical, and community pharmacist satisfaction","time_frame":"1 year after transplantation","description":"Assessing patient, medical, community pharmacist and trial satisfaction (thanks to a 5-level Likert scale) with the system implemented"},{"outcome_type":"secondary","measure":"Assessment of potential release risk by measuring the coefficient of variation (CV) of anticalcineurin doses","time_frame":"3 years after transplantation","description":"A patient with a CV greater than 30% will be considered to be at higher risk of rejection"},{"outcome_type":"secondary","measure":"For kidney transplantation : testing for anti-HLA antibodies","time_frame":"1 year and 3 years after transplantation","description":"Anti-HLA antibodies are known to be responsible for rejection in kidney transplants: search for anti-HLA antibodies directed against the donor one and three years after the transplant by Elisa technique"},{"outcome_type":"secondary","measure":"Determining the efficiency of the implementation of the PPP","time_frame":"1 year after transplantation","description":"Determining the efficiency of the implementation of this PPP in 3 different ways: by determining the cost per QALY gained at 1 year, the cost per additional patient adherent at 1 year and the cost per first functional graft in additional living patient (living patient, carrying their first graft and functional graft) at 1 year"}]}
{"nct_id":"NCT04513145","start_date":"2020-10-09","phase":"Phase 2/Phase 3","enrollment":130,"brief_title":"Adductor Canal Block","official_title":"Multimodal Periarticular Analgesic Injection With and Without Surgeon-Administered Adductor Canal Block During Total Knee Arthroplasty: A Randomized Controlled Trial","primary_completion_date":"2022-12-31","study_type":"Interventional","rec_status":"Enrolling by invitation","completion_date":"2023-07-31","last_update":"2020-10-28","description":"The investigators aim to investigate whether the addition of a surgeon-administered adductor canal blockade to a multimodal periarticular injection cocktail provides additional pain relief for patients undergoing total knee arthroplasty. This study will help identify the effectiveness of surgeon-administered adductor canal blockade in perioperative pain control for patients undergoing total knee arthroplasty","other_id":"9172","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":30,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        1. Patients age 30-85undergoing first-time primary unilateral total knee arthroplasty for\r\n        osteoarthritis and remaining hospitalized for at least one night\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients undergoing revision total knee arthroplasty\r\n\r\n          2. Patients undergoing bilateral total knee arthroplasty\r\n\r\n          3. Workers compensation patients\r\n\r\n          4. Patients undergoing total knee arthroplasty for post-traumatic arthritis\r\n\r\n          5. Patients with inflammatory arthritis\r\n\r\n          6. Patients with any previous surgery on the operative knee which involved an arthrotomy\r\n\r\n          7. Patients taking opioids prior to total knee arthroplasty\r\n\r\n          8. Patients with a known history of drug or alcohol abuse\r\n\r\n          9. Patients undergoing total knee arthroplasty at an ambulatory surgery center, or being\r\n             discharged home from the hospital on the same day as their procedure (planned)\r\n\r\n         10. Patients who have had a total knee arthroplasty performed on the contralateral knee\r\n      ","sponsor":"OrthoCarolina Research Institute, Inc.","sponsor_type":"Other","conditions":"Osteoarthritis|Total Knee Replacement","interventions":[{"intervention_type":"Drug","name":"Drug: Ropivacaine injection","description":"Ropivacaine is a local anesthetic that is FDA approved for local anesthetic nerve block."},{"intervention_type":"Drug","name":"Drug: Saline Injection","description":"Saline will be used as a placebo injection"},{"intervention_type":"Procedure","name":"Procedure: Total Knee Arthroplasty","description":"All subjects participating in this study will undergo primary total knee arthroplasty"}],"outcomes":[{"outcome_type":"primary","measure":"Postoperative pain, as defined by patient-reported NPRS pain scores on a scale of 0-10 on Postoperative day 1","time_frame":"Approximately 24 hours following closure","description":"Pain will be measured before discharge on postoperative day 1 on a scale of 0 (no pain) - 10 (worst pain)"},{"outcome_type":"secondary","measure":"Postoperative pain, as defined by patient-reported NPRS pain scores on a scale of 0-10 on Postoperative day 0, 1, 2, 4 and at 4-6 week postoperative visit","time_frame":"Every 6 hours for postoperative day 0-2, every 6 hours on postoperative day 4, and at 4-6 week visit","description":"Postoperative pain, as defined by patient-reported NPRS pain scores on a scale of 0 (no pain) - 10 (worst pain) on:\r\nPostoperative day 0: in PACU and Q 6 hours\r\nPostoperative day 1: Q 6 hours\r\nPostoperative day 2: Q 6 hours via pain diary\r\nPostoperative day 4: Q 6 hours via pain diary\r\n4-6 weeks postoperatively in office visit."},{"outcome_type":"secondary","measure":"Timed Up & Go test","time_frame":"24 hours following surgical closure","description":"Timed up & go test administered on postoperative day 1 by physical therapy"},{"outcome_type":"secondary","measure":"Gait Assessment","time_frame":"24 hours following surgical closure","description":"Assessment using 2 Minute walk test, administered by physical therapy on postoperative day #1"},{"outcome_type":"secondary","measure":"Range of Motion","time_frame":"24 hours following surgical closure","description":"Range of motion in knee flexion and extension on postoperative day 1 administered by physical therapy"},{"outcome_type":"secondary","measure":"Range of Motion","time_frame":"4-6 weeks","description":"Range of motion in knee flexion and extension at 4-6 week visit administered by treating surgeon"},{"outcome_type":"secondary","measure":"Quadriceps Strength","time_frame":"24 hours following surgical closure","description":"Quadriceps Strength (motor blockade) as demonstrated by ability to have active extension and perform a straight leg raise at Physical Therapy on postoperative day # 0 and postoperative day #1 prior to discharge."},{"outcome_type":"secondary","measure":"Patient Satisfaction with Pain","time_frame":"4-6 week visit","description":"Patient-reported satisfaction with pain control on a 10-point Likert scale where 10 is the highest satisfaction"},{"outcome_type":"secondary","measure":"Pain Diary","time_frame":"7 days following surgical closure","description":"Patient-reported opioid consumption in morphine milliequivalents in first 7 days postoperatively as recorded in a pain diary"}]}
{"nct_id":"NCT04426981","start_date":"2020-10-09","phase":"N/A","enrollment":20,"brief_title":"Behavioral Activation in Orthopaedic Trauma Patients: A Pilot Study","official_title":"Behavioral Activation in Orthopaedic Trauma Patients: A Pilot Study","primary_completion_date":"2021-10-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-12-31","last_update":"2021-05-27","description":"This is a prospective observational pilot study designed to evaluate feasibility and acceptability as well as preliminary efficacy of a behavioral activation intervention among orthopaedic trauma patients after discharge home following their injury.","other_id":"D20133","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients 18 years or older\r\n\r\n          -  Presenting at initial (approximately 2-week) postoperative follow-up\r\n\r\n          -  Prior management of isolated fracture or multi-trauma\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Incarceration\r\n\r\n          -  Problems, in the judgement of study personnel, with maintaining follow-up\r\n\r\n          -  Cognitive disability (either acute or chronic)\r\n      ","sponsor":"Dartmouth-Hitchcock Medical Center","sponsor_type":"Other","conditions":"Fractures, Bone","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Behavioral Activation","description":"Behavioral activation is a behavioral treatment that focuses on helping participants engage in more rewarding and enjoyable activities. In the first session, participants will begin to identify domains of their life which are important to them. In the second session, participants will be assisted in creating an action plan to engage in more activities in one or more domains of importance. In session 3-8, participants will be assisted in problem solving any challenges they encountered in implementing their previous action plan and will develop a new action plan. The intervention will continue until participants achieved three action plans or reach the eight-session limit, whichever comes first."}],"outcomes":[{"outcome_type":"primary","measure":"Score on Modified Treatment Evaluation Inventory Short Form","time_frame":"6 months","description":"Acceptability will be measured qualitatively and using the Modified Treatment Evaluation Inventory Short Form"},{"outcome_type":"primary","measure":"Percentage of patients who agree to enroll","time_frame":"6 months","description":"Feasibility will be assessed based on percentage of patients who agree to enroll sessions"},{"outcome_type":"primary","measure":"Percentage of patients who complete 5 out of 8 possible Behavioral Activation sessions","time_frame":"6 months","description":"Feasibility will be assessed based on patients who complete 5 out of 8 possible Behavioral Activation Sessions"},{"outcome_type":"secondary","measure":"Score on PROMIS general health survey (Response range is 0 to 100 where 100 indicates better function)","time_frame":"6 months","description":"Preliminary efficacy on functional outcome will be assessed using patient reported functional outcome using PROMIS general health survey"},{"outcome_type":"secondary","measure":"Score on VAS pain score (Response range is from 0 to 10 where 10 indicates greater pain)","time_frame":"6 months","description":"Pain-related preliminary efficacy will be assessed using patient reported VAS pain score will be assessed"}]}
{"nct_id":"NCT04877899","start_date":"2020-10-08","enrollment":250,"brief_title":"Mazankowski Alberta Heart Institute (MAHI) EchoGo Discovery 1 Protocol","official_title":"Mazankowski - Echo Go Discovery Protocol Retrospective LVEF/GLS Comparison","primary_completion_date":"2021-03-31","study_type":"Observational","rec_status":"Enrolling by invitation","completion_date":"2021-11-30","last_update":"2021-09-05","description":"This study aims to compare conventionally acquired Left Ventricle Ejection Fraction (LVEF) and Global Longitudinal Strain (GLS) data to Artificial Intelligence (AI) driven automated processing of 2 dimensional contrast and 2 dimensional non-contrast resting transthoracic echocardiograms for application in the assessment of patients undergoing chemotherapy with cardiotoxic drugs. This is a single-centre retrospective study which utilizes echocardiographic DICOM image and meta-data datasets received from a Canadian site. Data processed using the AI driven automated processing will be compared to conventionally acquired LVEF and GLS measurements and results will be analysed to determine accuracy and precision.","other_id":"COL-04","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"- Data included for analysis in this study will be retrospective data from male and female\r\n        patients aged 18 years or above who received an echocardiogram for baseline and follow-up\r\n        of cardiotoxic agent management, who agreed to participate in the echocardiography registry\r\n        of the MAHI, and who have already provided a written consent that their anonymized imaging\r\n        data can be used to advance echocardiographic assessment of LV function.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Normal EF and no regional wall motion abnormalities prior to starting chemotherapy\r\n             treatment.\r\n\r\n          -  Follow-up EF measurements available for at least 1 year during the treatment period.\r\n\r\n          -  Follow-up EF measurements for at least 1 year during the treatment period.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Age < 18 years\r\n\r\n          -  Inadequate image quality (as determined by the Ultromics Operators Quality Control\r\n             process)\r\n      ","sponsor":"Ultromics Ltd","sponsor_type":"Industry","conditions":"Cardiotoxicity|Cancer","interventions":[{"intervention_type":"Device","name":"Device: EchoGo","description":"EchoGo Core is a stand-alone software application. Echocardiograms should be acquired under the supervision of a physician and standard clinical protocols which includes focused apical 2, 3 and 4 chamber views. The results contain calculated measurements that will be returned to the interpreting physician. These results are intended as an additional input to standard diagnostic pathways and should only be used by a board-certified cardiologist/physician.\r\nEchoGo Core is intended to be used for the quantification and reporting of results of cardiovascular function to support physician diagnosis. EchoGo Core is indicated for use in adult populations."}],"outcomes":[{"outcome_type":"primary","measure":"Compare the performance of automated EF and GLS measurements in resting transthoracic echocardiograms against conventional measurement acquisition.","time_frame":"Baseline","description":"Measurements shall be compared using bias and 95% confidence intervals on bias. Regression coefficients and comparative statistics will be employed for this objective."},{"outcome_type":"primary","measure":"Compare the performance of automated EF and GLS measurements in resting transthoracic echocardiograms against conventional measurement acquisition.","time_frame":"Follow up (up to 1 year)","description":"Measurements shall be compared using bias and 95% confidence intervals on bias. Regression coefficients and comparative statistics will be employed for this objective."},{"outcome_type":"primary","measure":"Compare the performance of automated EF and GLS measurements in resting transthoracic echocardiograms with and without the application of contrast agents.","time_frame":"Baseline","description":"Measurements will be assessed using bias and 95% confidence internals on bias. Regression coefficients, comparative statistics and equivalence testing might also be employed as a comparison measure for this objective."},{"outcome_type":"primary","measure":"Compare the performance of automated EF and GLS measurements in resting transthoracic echocardiograms with and without the application of contrast agents.","time_frame":"Follow up (up to 1 year)","description":"Measurements will be assessed using bias and 95% confidence internals on bias. Regression coefficients, comparative statistics and equivalence testing might also be employed as a comparison measure for this objective."}]}
{"nct_id":"NCT04739163","start_date":"2020-10-01","enrollment":18,"brief_title":"Urdu Translation of Duke Activity Status","official_title":"Translation and Cross-cultural Adaptation of the Duke Activity Status Index to Urdu","primary_completion_date":"2021-03-01","study_type":"Observational","rec_status":"Completed","completion_date":"2021-04-01","last_update":"2021-05-20","description":"To translate, culturally adapt, and validate the Duke Activity Status Index (DASI) to the Pakistani Urdu language. The study will measure the reliability & validity of DASI in the Urdu version.No study has been conducted in the Pakistan region to translate DASI which follows the proper cross-culture adaptation.","other_id":"REC/00783 Abdul Majid Saeed","observational_model":"Other","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":22,"maximum_age":60,"population":"To meet inclusion criteria participants will be diagnosed with heart disease, clinically\r\n        stable, and able to read the Urdu version of DASI. Then patient response will be checked on\r\n        the translated Urdu version.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Individuals have enough education level to understand Urdu and English as well with a\r\n             body mass index between 18.6 and 39.9 kg/m with the diagnosis of cardiovascular\r\n             diseases such as coronary artery disease, valvular heart disease, arrhythmia with at\r\n             least one symptom11 such as chest pain, palpitations, fatigue, or dyspnea, and\r\n             physician referral to exercise testing.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Individual is unable to read the questionnaire, who have cognitive deficits screened\r\n             by Mini-Mental State Examination according to the cut-off points and Hospitalization\r\n             two months before as well as acute illness, fever, or severe physical limitation that\r\n             would prevent from doing the exercise test.\r\n      ","sponsor":"Riphah International University","sponsor_type":"Other","conditions":"Heart Diseases","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Translation of Duke Activity Status Index (DASI) in Urdu","time_frame":"6 months","description":"The Duke Activity Status Index Scale (DASI) is a questionnaire, originally developed in English to assess the functional capacity. DASI has been used mainly to evaluate patients with cardiovascular diseases, such as coronary artery disease, heart failure, myocardial ischemia and infarction."},{"outcome_type":"secondary","measure":"validity & reliability of Duke Activity Status Index Scale (DASI) in Urdu version","time_frame":"6 months","description":"Reliability and validity are concepts used to evaluate the quality of research. They indicate how well a method, technique or test measures something. Reliability is about the consistency of a measure, and validity is about the accuracy of a measure."}]}
{"nct_id":"NCT04990986","start_date":"2020-10-01","phase":"N/A","enrollment":460,"brief_title":"Co-Development and Evaluation of a Complex Intervention to Increase Medication Safety in Nursing Homes","official_title":"Co-Development and Evaluation of a Complex Intervention to Increase Medication Safety in Nursing Homes - A Mixed Methods Study Embedding a Cluster Randomised Controlled Trial, Guided by Safety Theory With Participatory Approach","primary_completion_date":"2022-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-12-31","last_update":"2021-08-05","description":"The study aims to develop and evaluate a new, multifaceted (complex) intervention in a mixed methods study-design to increase medication safety in nursing homes. The SAME-study will be locally anchored, including investigation of patient safety culture, in a mixed methods design, including both in depth qualitative and organizational-focused quantitative methods.","other_id":"AalborgH2021-015","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","intervention_model_description":"This study applies mixed-methods pragmatic paradigm led by Safety 1 and 2 theory, with participatory approach to an exploratory sequential three-phased study-design, embedding a cluster-randomized controlled trial (cRCT).","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":99,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  involved directly or indirectly in the medication process\r\n\r\n          -  employment of at least two months in a nursing-home within the municipality of\r\n             Aalborg, sufficient spoken and written Danish language\r\n\r\n        Exclusion Criteria:\r\n\r\n        -\r\n      ","sponsor":"Anne Estrup Olesen","sponsor_type":"Other","conditions":"Medication Safety|Patient Safety","interventions":[{"intervention_type":"Other","name":"Other: Complex intervention","description":"Will be co-developed during the study."}],"outcomes":[{"outcome_type":"primary","measure":"Care staff's perceptions of patient safety culture","time_frame":"One year","description":"Safety Attitudes Questionnaire (SAQ)"},{"outcome_type":"secondary","measure":"Perceptions of patient safety culture of relatives of residents and nursing home doctors.","time_frame":"One year","description":"Qualitative data will be collected through individual interviews with relatives and GPs"},{"outcome_type":"other","measure":"Safety assessments","time_frame":"One year","description":"data from medical records and national registers will be used for safety assessments."}]}
{"nct_id":"NCT04572204","start_date":"2020-10-01","enrollment":33,"brief_title":"Management of Grades 3-5 Renal Trauma in Pediatrics","official_title":"Management of Grades 3-5 Renal Trauma in Pediatrics: A Prospective Case Series","primary_completion_date":"2022-09-30","study_type":"Observational","rec_status":"Active, not recruiting","completion_date":"2022-10-30","last_update":"2021-03-10","description":"comparing conservative management versus interventional management in hemodynamically stable paediatric patient with blunt renal trauma, evidence suggests that there is a reduced rate of renal loss and blood transfusion in patients managed conservatively.","other_id":"Renal trauma management","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","maximum_age":18,"population":"60 children (age group 0-18 years) will be added to my study divided into two groups\r\n        regardless of sex","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Children ( age group 0-18) who are diagnosed to have renal tissue injury grade 3-5 by\r\n             contrast CT\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Age group more than 18 years\r\n\r\n          -  Low grade renal trauma 1-2\r\n\r\n          -  Patients who get explored due to extra urologic indication without proper urologic\r\n             assessment\r\n      ","sponsor":"Assiut University","sponsor_type":"Other","conditions":"Renal Trauma","interventions":[{"intervention_type":"Other","name":"Other: Surgical","description":"Minimal: Such as PCN insertion Endosopic: Such as DJ insertion Surgical: Repair, Partial or total nephrectomy Angioembolization"}],"outcomes":[{"outcome_type":"primary","measure":"Stabilization of haemodynamic status of the patient in the first 24-72 hours","time_frame":"24 to 72 hours"},{"outcome_type":"secondary","measure":"Resolution of perinephric collection during follow up Triphasic MSCT abdomen and pelvis","time_frame":"1 year"}]}
{"nct_id":"NCT04198129","start_date":"2020-10-01","phase":"Phase 1","enrollment":174,"brief_title":"The Evaluation of Postoperative Antibiotics in Non-Infected Mandible Fractures","official_title":"The Evaluation of Postoperative Antibiotics in Non-Infected Mandible Fractures","primary_completion_date":"2022-01-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-03-01","last_update":"2020-11-18","description":"The purpose of the study is to evaluate if postoperative antibiotic use in patients with mandible trauma reduce the risk of postoperative infections and does the benefit differ based on severity, soft tissue loss, other concomitant injuries, and medical problems","other_id":"HSC-MS-18-0640","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  All mandible fracture patients planned for Open Reduction and Internal Fixation (ORIF)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Age - < 18 years\r\n\r\n          -  Pregnancy\r\n\r\n          -  Fracture Site - closed / non-dentate eg. Condylar neck, edentulous\r\n\r\n          -  Soft Tissue Injury - > Grade 4 (GSW)\r\n\r\n          -  Allergic to all study drugs\r\n\r\n          -  Medical Problems\r\n\r\n               1. Diabetes - Hb A1C > 10\r\n\r\n               2. Immunologic compromise\r\n\r\n               3. On Chemotherapy\r\n\r\n          -  Interval - Injury to Surgery - > 10days\r\n\r\n          -  Already receiving antibiotics for\r\n\r\n               1. Another wound eg. Open fracture prophylaxis\r\n\r\n               2. Documented / suspected infection\r\n\r\n          -  Inability to provide informed consent.\r\n      ","sponsor":"The University of Texas Health Science Center, Houston","sponsor_type":"Other","conditions":"Jaw Fractures|Infection","interventions":[{"intervention_type":"Drug","name":"Drug: Antibiotic treatment (Unasyn or Cleocin)","description":"Trial groups will receive a single post-operative dose administration of Unasyn 3g or Clindamycin 600mg (for penicillin allergies)"},{"intervention_type":"Drug","name":"Drug: Antibiotic treatment (Augmentin or Cleocin)","description":"the patients in the trial group will be switched to oral Augmentin 875mg twice a day for 7 days, or oral Clindamycin 150mg to 300mg four times a day for 7 days (for penicillin allergies)."},{"intervention_type":"Other","name":"Other: Control Group","description":"Control group will not receive any postoperative antibiotics other than what is accepted as preoperative prophylactic antibiotics as per current standards of care"}],"outcomes":[{"outcome_type":"secondary","measure":"No evidence of infection as measured by absence of fever","time_frame":"post treatment week 6-8"},{"outcome_type":"secondary","measure":"No evidence of infection as measured by absence of recurrent swelling","time_frame":"post treatment week 1"},{"outcome_type":"secondary","measure":"No evidence of infection as measured by absence of recurrent swelling","time_frame":"post treatment week 3"},{"outcome_type":"secondary","measure":"No evidence of infection as measured by absence of recurrent swelling","time_frame":"post treatment week 6-8"},{"outcome_type":"secondary","measure":"No evidence of infection as measured by absence of erythema","time_frame":"post treatment week 1"},{"outcome_type":"secondary","measure":"No evidence of infection as measured by absence of erythema","time_frame":"post treatment week 3"},{"outcome_type":"secondary","measure":"No evidence of infection as measured by absence of erythema","time_frame":"post treatment week 6-8"},{"outcome_type":"secondary","measure":"No evidence of infection as measured by absence of persistent swelling","time_frame":"post treatment week 1"},{"outcome_type":"secondary","measure":"No evidence of infection as measured by absence of persistent swelling","time_frame":"post treatment week 3"},{"outcome_type":"secondary","measure":"No evidence of infection as measured by absence of persistent swelling","time_frame":"post treatment week 6-8"},{"outcome_type":"secondary","measure":"No evidence of infection as measured by absence of fever","time_frame":"post treatment week 1"},{"outcome_type":"secondary","measure":"No evidence of infection as measured by absence of fever","time_frame":"post treatment week 3"},{"outcome_type":"primary","measure":"Evidence of infection as measured by presence of persistent swelling,","time_frame":"post treatment week1"},{"outcome_type":"primary","measure":"Evidence of infection as measured by presence of persistent swelling,","time_frame":"post treatment week 3"},{"outcome_type":"primary","measure":"Evidence of infection as measured by presence of persistent swelling,","time_frame":"post treatment week 6-8"},{"outcome_type":"primary","measure":"Evidence of infection as measured by presence of fever","time_frame":"post treatment week 1"},{"outcome_type":"primary","measure":"Evidence of infection as measured by presence of fever","time_frame":"post treatment week 3"},{"outcome_type":"primary","measure":"Evidence of infection as measured by presence of fever","time_frame":"post treatment week 6-8"},{"outcome_type":"primary","measure":"Evidence of infection as measured by presence of recurrent swelling","time_frame":"post treatment week 1"},{"outcome_type":"primary","measure":"Evidence of infection as measured by presence of recurrent swelling","time_frame":"post treatment week 3"},{"outcome_type":"primary","measure":"Evidence of infection as measured by presence of recurrent swelling","time_frame":"post treatment week 6-8"},{"outcome_type":"primary","measure":"Evidence of infection as measured by presence of erythema","time_frame":"post treatment week 1"},{"outcome_type":"primary","measure":"Evidence of infection as measured by presence of erythema","time_frame":"post treatment week 3"},{"outcome_type":"primary","measure":"Evidence of infection as measured by presence of erythema","time_frame":"post treatment week 6-8"},{"outcome_type":"primary","measure":"Evidence of infection as measured by presence of purulent discharge","time_frame":"post treatment week 1"},{"outcome_type":"primary","measure":"Evidence of infection as measured by presence of purulent discharge","time_frame":"post treatment week 3"},{"outcome_type":"primary","measure":"Evidence of infection as measured by presence of purulent discharge","time_frame":"post treatment week 6-8"},{"outcome_type":"secondary","measure":"No evidence of infection as measured by absence of purulent discharge","time_frame":"post treatment week 1"},{"outcome_type":"secondary","measure":"No evidence of infection as measured by absence of purulent discharge","time_frame":"post treatment week 3"},{"outcome_type":"secondary","measure":"No evidence of infection as measured by absence of purulent discharge","time_frame":"post treatment week 6-8"}]}
{"nct_id":"NCT04578080","start_date":"2020-10-01","phase":"N/A","enrollment":45,"brief_title":"Effect of tDCS on Motor Functions and Brain Activity in Acute Stroke Patients","official_title":"Effect of tDCS on Motor Functions and Brain Activity in Acute Stroke Patients","primary_completion_date":"2021-10-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-12-31","last_update":"2020-12-11","description":"This study aims to investigate the effects of anodal- and cathodal tDCS combined with conventional physical therapy for 5 consecutive sessions on motor functions and brain activity in acute stroke patients at immediate and 1-month follow-up.","other_id":"SI284/2020","allocation":"Randomized","intervention_model":"Factorial Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age between 18-75 years old\r\n\r\n          2. First-ever acute ischemic stroke of anterior circulation system (anterior cerebral\r\n             artery or middle cerebral artery territory)\r\n\r\n          3. Stroke onset from 2-10 days\r\n\r\n          4. Having a stable medical condition\r\n\r\n          5. Alert of consciousness\r\n\r\n          6. Able to follow commands\r\n\r\n          7. Modified Rankin Scale (mRS)  4\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Hemorrhagic stroke\r\n\r\n          2. Recurrent stroke\r\n\r\n          3. Presence of other neurological disorders such as unilateral neglect\r\n\r\n          4. Presence of metal implantation, intracranial shunt, cochlear implantation or cardiac\r\n             pacemakers\r\n\r\n          5. Presence of opened wound or infectious wound around scalp\r\n\r\n          6. History of epilepsy or any neurological antecedent or unstable condition which can\r\n             lead to seizure\r\n\r\n          7. Body Mass Index (BMI) > 30 kg/m2\r\n\r\n          8. Received hormonal treatment\r\n\r\n          9. Ischemic heart disease and peripheral vascular ischemia\r\n\r\n         10. Last stage of kidney disease and liver disease\r\n      ","sponsor":"Mahidol University","sponsor_type":"Other","conditions":"Stroke, Acute","interventions":[{"intervention_type":"Device","name":"Device: Transcranial direct current stimulation","description":"Anodal/Cathodal/Sham tDCS will be applied in 1.5 mA, 20 mins before conventional physical therapy for 5 days. All experiments will be performed in random order for each subject."}],"outcomes":[{"outcome_type":"primary","measure":"Electroencephalography","time_frame":"10 minutes","description":"Brain activity will be recorded during eyes open (5 minutes) follow by eyes close (5 minutes)."},{"outcome_type":"secondary","measure":"Fugl-Meyer Assessment","time_frame":"20 minutes","description":"The gold standard and widely used tool to assess sensorimotor in stroke. The item from upper limb and lower limb section will be used. The items are rated on a 3-point ordinal scale as follows: 0 = unable to perform; 1 = partial ability to perform; and 2 = near normal ability to perform."},{"outcome_type":"other","measure":"Wolf Motor Function Test","time_frame":"5 minutes","description":"Two sub-items (lift a can and lift a pencil) will be evaluated in all participants."}]}
{"nct_id":"NCT04549584","start_date":"2020-10-01","enrollment":3,"brief_title":"Neoadjuvant Chemotherapy Response in Metaplastic Carcinoma of Triple Negative Breast Cancer","official_title":"Neoadjuvant Chemotherapy Response in Metaplastic Carcinoma of Triple Negative Breast Cancer","primary_completion_date":"2020-12-16","study_type":"Observational [Patient Registry]","rec_status":"Terminated","completion_date":"2020-12-16","last_update":"2020-12-17","description":"prospective study for response of neoadjuvant chemotherapy in metaplastic carcinoma of triple negative breast cancer","other_id":"2004-261-112","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":20,"population":"-  over 20 years old\r\n\r\n          -  patients with triple negative breast cancer diagnosed Seoul National University\r\n             Hospital","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  over 20 years old\r\n\r\n          -  patients with triple negative breast cancer diagnosed Seoul National University\r\n             Hospital\r\n\r\n          -  patients who decided to perform neoadjuvant chemotherapy under clinical judgement\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  not applicable\r\n      ","sponsor":"Seoul National University Hospital","sponsor_type":"Other","conditions":"Metaplastic Breast Carcinoma","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Vimentin/pan CK stain","description":"Vimentin/pan CK stain positive/negative"}],"outcomes":[{"outcome_type":"primary","measure":"response rate of neoadjuvant chemotherapy","time_frame":"After neoadjuvant chemotherapy was finished. Average 6 month later.","description":"response criteria for neoadjuvant chemotherapy-complete response (CR), partial response (PR), and no response (NR)"}]}
{"nct_id":"NCT04572074","start_date":"2020-10-01","phase":"N/A","enrollment":128,"brief_title":"Virtual Reality for Cancer Pain Management","official_title":"Pilot Study to Evaluate Virtual Reality for Cancer Pain Management","primary_completion_date":"2022-09-29","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2022-09-30","last_update":"2020-10-01","description":"The purpose of this research project is to evaluate the impact of virtual reality therapy on mitigating cancer pain in hospitalized patients with cancer and compare this impact to that of 2-dimensional guided imagery distraction therapy. The purpose is also to evaluate acceptability of and satisfaction with virtual reality therapy and to examine racial and cultural preferences related to virtual reality and guided imagery thematic content.","other_id":"2017-240","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  hospitalized, with primary diagnosis of cancer\r\n\r\n          -  age 18 and older\r\n\r\n          -  report moderate-severe pain (at least 4 out of 10 where pain is rated on a Likert\r\n             scale between zero and 10) in the previous 24 hours\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  already use VR for personal use\r\n\r\n          -  intractable nausea/vomiting\r\n\r\n          -  history of motion sickness\r\n\r\n          -  history of seizures or epilepsy\r\n\r\n          -  have cranial structure abnormalities that prevent use of VR headset\r\n\r\n          -  currently enrolled in a palliative care or pain management study\r\n\r\n          -  on contact isolation\r\n      ","sponsor":"Medstar Health Research Institute","sponsor_type":"Other","conditions":"Cancer|Cancer Pain","interventions":[{"intervention_type":"Other","name":"Other: Guided imagery","description":"10 minutes of guided imagery experience"},{"intervention_type":"Other","name":"Other: Virtual reality","description":"10 minutes of virtual reality experience"}],"outcomes":[{"outcome_type":"secondary","measure":"Acceptability of intervention (\"Would you use this intervention again?\") -- this single question designed for this study","time_frame":"Immediately after intervention","description":"Single best answer: subjects choose between two choices, \"Yes\" or \"No\""},{"outcome_type":"secondary","measure":"Level of immersion experienced in virtual reality arm","time_frame":"Immediately after intervention (virtual reality arm only)","description":"Immersive Experience Questionnaire"},{"outcome_type":"primary","measure":"Change in self-reported pain score from baseline to immediately after assigned intervention","time_frame":"Baseline and again immediately after assigned intervention","description":"Likert scale 0 (no pain) to 10 (worst pain)"},{"outcome_type":"secondary","measure":"Change in self-reported distress from baseline to immediately after assigned intervention","time_frame":"Baseline and immediately after intervention, 24 hours after intervention","description":"National Comprehensive Cancer Network Distress Thermometer"},{"outcome_type":"secondary","measure":"Change in self-reported quality of life from baseline to immediately after assigned intervention","time_frame":"Immediately after assigned intervention","description":"Functional Assessment in Chronic Illness-Therapy in Palliative Care 14-item scale (FACIT Pal 14 scale) -- subject replies to 14 questions about quality of life issues with responses in 5-point Likert scale (0 = not at all; 4 = very much), total score range 0-56"},{"outcome_type":"secondary","measure":"Ease of intervention (\"How easy was this technology for you to use?\") -- this single question designed for this study","time_frame":"Immediately after assigned intervention","description":"Single best answer to this question: subjects choose between \"easy,\" \"normal,\" or \"difficult\""},{"outcome_type":"secondary","measure":"Change in self reported distress from baseline to Immediately after assigned intervention","time_frame":"Immediately after assigned intervention","description":"National Comprehensive Cancer Network Distress Thermometer -- subject rates distress at that point in time on Likert scale 0-10 (0 = no distress; 10 = worst distress)"}]}
{"nct_id":"NCT04330027","start_date":"2020-09-30","phase":"N/A","enrollment":60,"brief_title":"Effectiveness of Lyophilized Growth Factors for Subacromial Impingement","official_title":"Effectiveness of Lyophilized Growth Factors for Subacromial Impingement: Randomized Double Blind Placebo Controlled Study","primary_completion_date":"2021-04-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-06-30","last_update":"2020-07-09","description":"The aim of this study is to evaluate the efficacy of ultrasound-guided injection of platelet-derived lyophilized growth factors in treatment of subacromial impingement.","other_id":"0106178","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Clinically:\r\n\r\n               1. Anterolateral shoulder and/or lateral upper arm pain.\r\n\r\n               2. Painful arc of motion between 70 and 120.\r\n\r\n               3. Positive impingement sign (Neer's test or Hawkins-Kennedy test).\r\n\r\n          -  Ultrasonographically:\r\n\r\n        The elicitation of a transient arc of pain during shoulder abduction which coincides with\r\n        passage of the supraspinatus insertion beneath the coraco-acromial arch.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of shoulder surgery, fracture, dislocation or subluxation.\r\n\r\n          -  Patients with full-thickness rotator cuff tear, weakness on arm elevation, or positive\r\n             \"drop arm sign\".\r\n\r\n          -  Patients who have been diagnosed with a frozen shoulder or degenerative arthropathy of\r\n             the glenohumeral joint.\r\n\r\n          -  Patients with disorders of the cervical spine or upper extremity that have a\r\n             significant impact on the shoulder\r\n\r\n          -  Patients with diabetes mellitus, rheumatoid arthritis, hypothyroidism or other painful\r\n             or function limiting disorders of the shoulder.\r\n\r\n          -  Significant cardiovascular, renal or hepatic disease.\r\n\r\n          -  Active infection in the area to be treated.\r\n      ","sponsor":"Alexandria University","sponsor_type":"Other","conditions":"Shoulder Impingement Syndrome","interventions":[{"intervention_type":"Biological","name":"Biological: Growth factors","description":"A new patented product named lyophilized Growth Factors that is an advanced and refined form of conventional platelet-rich plasma"},{"intervention_type":"Other","name":"Other: Saline","description":"0.9% Sodium Chloride"}],"outcomes":[{"outcome_type":"primary","measure":"VAS (Visual Analogue Scale)","time_frame":"8 weeks","description":"Pain assessment scale. The minimum value is zero and the maximum value is 10. A higher score indicates a worse outcome."},{"outcome_type":"primary","measure":"SPADI (Shoulder Pain and Disability Index)","time_frame":"8 weeks","description":"An index measuring the impact of shoulder pathology in terms of pain and disability.\r\nTotal pain score: / 50 x 100 = % Total disability score: / 80 x 100 = % Total Spadi score: / 130 x 100 = % (Note: If a person does not answer all questions divide by the total possible score, eg. if 1 question missed divide by 120) The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst).\r\nA higher score indicates a worse outcome."}]}
{"nct_id":"NCT04270188","start_date":"2020-09-30","enrollment":66,"brief_title":"Evolution of Symptoms After Anterior Sacrospinofixation by Autologous Tissues","official_title":"Prospective Study of the Evolution of Symptoms After Anterior Sacrospinofixation by Autologous Tissues","primary_completion_date":"2024-09-30","study_type":"Observational","rec_status":"Not yet recruiting","completion_date":"2024-09-30","last_update":"2020-07-21","description":"Prolapse is a pathology that can cause pelvic, urinary or sexual functional disorders and impaired quality of life. Although the use of vaginal mesh is a commonly practiced technique to correct prolapse, in recent years health officials have pointed to the lack of adequate safety and tolerability assessments of these implants. Currently, surgeons are therefore moving towards techniques without implants. The standard vaginal technique for the treatment of uterine prolapse is sacrospinofixation according to Richter. This technique can be performed without an implant, using autologous tissue. Functional discomfort of patients is the main problem linked to the presence of prolapse. However, no study has yet evaluated the feelings of patients following the use of this sacrospinofixation technique by autologous tissues by vaginal route, which led us to set up this study. The hypothesis is that the technique of anterior sacrospinofixation by autologous tissues improves the symptoms experienced by patients with an mid-level and / or anterior genital prolapse.","other_id":"69HCL20_0077","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"Female","minimum_age":18,"population":"patients over 18 years old with middle and / or anterior prolapse  II in the POP-Q\r\n        classification and for whom an intervention by anterior sacrospinofixation by autologous\r\n        tissues is planned.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  women over 18\r\n\r\n          -  middle and / or anterior genital prolapse (hysterocele and / or cystocele) requiring\r\n             surgical correction of stage  II in the POP-Q classification\r\n\r\n          -  patients wanting an intervention because of the discomfort caused by the prolapse\r\n\r\n          -  intervention planned by anterior sacrospinofixation by autologous tissues\r\n\r\n          -  person having expressed his non-opposition\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  prolapse of stage < II in the POP-Q classification, or prolapse without functional\r\n             impairment\r\n\r\n          -  disorders involving an unacceptable risk of postoperative complications sought after\r\n             questioning of the patient (blood coagulation disorders, immune system disorders,\r\n             progressive diseases, etc.)\r\n\r\n          -  reduced mobility of the lower limbs (not allowing positioning for surgery)\r\n\r\n          -  pregnancy or any pregnancy plan for the duration of the study\r\n\r\n          -  active or latent infection\r\n\r\n          -  inability to understand the information given\r\n\r\n          -  person deprived of liberty, under guardianship.\r\n      ","sponsor":"Hospices Civils de Lyon","sponsor_type":"Other","conditions":"Pelvic Organ Prolapse","interventions":[{"intervention_type":"Other","name":"Other: evolution of patient symptoms","description":"evolution of symptoms on the PGI-I scale (score 1, 2, or 3) 2 months after surgery"}],"outcomes":[{"outcome_type":"primary","measure":"improvement of symptoms","time_frame":"at Month 2","description":"percentage of patients with symptom change on the PGI-I scale (score 1, 2, or 3)"}]}
{"nct_id":"NCT04459299","start_date":"2020-09-28","enrollment":100,"brief_title":"CorPath GRX STEMI Study","official_title":"An Evaluation of Performance of the CorPath GRX System in Robotic-PCI During Acute STEMI","primary_completion_date":"2021-10-01","study_type":"Observational","rec_status":"Recruiting","completion_date":"2021-10-05","last_update":"2021-03-17","description":"This study will evaluate the performance of the CorPath GRX System in Robotic Primary PCI (RPPCI) in the treatment of ST-elevated myocardial infarction (STEMI).","other_id":"104-09062","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":80,"population":"Subjects with a clinical indication of STEMI.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age 18 and  80 years\r\n\r\n          -  Patients with STEMI<12 h of symptom onset\r\n\r\n          -  Patient deemed appropriate for robotic-assisted PCI\r\n\r\n          -  The subject has been informed of the nature of the study, agrees to its provisions,\r\n             and has provided written consent\r\n\r\n        Exclusion Criteria:\r\n\r\n        Cardiogenic shock\r\n\r\n          -  Cardiac arrest\r\n\r\n          -  Need for manual or mechanical thrombectomy\r\n\r\n          -  Failure/inability/unwillingness to provide informed consent\r\n\r\n          -  The Investigator determines that the subject or the coronary anatomy is not suitable\r\n             for robotic-assisted primary PCI treatment\r\n      ","sponsor":"Corindus Inc.","sponsor_type":"Industry","conditions":"STEMI - ST Elevation Myocardial Infarction|CAD","interventions":[{"intervention_type":"Procedure","name":"Procedure: Robotic-PCI (CorPath GRX System)","description":"Robotic-PCI for acute ST elevation myocardial infarction (STEMI)."}],"outcomes":[{"outcome_type":"primary","measure":"Time from Catheterization Lab Arrival to Device Activation (CLADA) by CorPath GRX System.","time_frame":"Procedure","description":"Time measured from arrival to Cath Lab to device activation by CorPath GRX System."},{"outcome_type":"secondary","measure":"Freedom from MACE events","time_frame":"72-hours","description":"Completion of the STEMI procedure without in-hospital major adverse cardiovascular event MACE). MACE is defined as cardiac death, clinically driven target vessel revascularization (TVR) by repeat PCI, surgical bypass for any segment of the target vessel or stent thrombosis."},{"outcome_type":"secondary","measure":"First Medical Contact (FMC) to device activation time","time_frame":"Procedure","description":"Time at which first patient evaluation."},{"outcome_type":"secondary","measure":"Access to device activation","time_frame":"Procedure","description":"Time measured from access sheath insertion to device activation by CorPath GRX System."},{"outcome_type":"secondary","measure":"Access to wire time","time_frame":"Procedure","description":"Defined as time measured from sheath insertion to crossing the lesion with the coronary guidewire."},{"outcome_type":"secondary","measure":"Overall procedure time","time_frame":"Procedure","description":"Defined as the time measured from sheath insertion to removal of the last device used to treat the culprit lesion."},{"outcome_type":"secondary","measure":"Fluoroscopy time","time_frame":"Procedure","description":"Total fluoroscopy time (min.) utilized during the procedure as recorded by the Imaging System."},{"outcome_type":"secondary","measure":"Patient radiation exposure","time_frame":"Procedure","description":"DAP (dose-area-product) and AK (air kerma) as recorded during the procedure."},{"outcome_type":"secondary","measure":"Contrast fluid volume","time_frame":"Procedure","description":"Total contrast volume (mL/cc) used during the procedure."},{"outcome_type":"secondary","measure":"Conversion to manual (Binary)","time_frame":"Procedure","description":"Conversion from robotic technique to manual technique due to inability to successfully wire lesion or deliver first device."},{"outcome_type":"secondary","measure":"Technical success","time_frame":"Procedure","description":"Completion of the PCI procedure entirely robotically or with partial manual assistance."},{"outcome_type":"secondary","measure":"Serious adverse events","time_frame":"72-hours","description":"All Serious Adverse Events (SAEs) from the start of the CorPath GRX procedure until the end of the study will be summarized."}]}
{"nct_id":"NCT04281316","start_date":"2020-09-23","phase":"N/A","enrollment":36,"brief_title":"High-Flow in Hypercapnic Stable COPD Patients","official_title":"Impact of Nasal High Flow (NHF) Versus Home Non-invasive Ventilation (NIV) on Nocturnal Transcutaneous PCO2 (PtCO2) in Stable COPD Patients: A Non-inferiority Study","primary_completion_date":"2021-09-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-01-31","last_update":"2021-04-29","description":"Monocentric, prospective, open, randomized 1:1, controlled study to evaluate the impact of nasal high-flow (NHF) on nocturnal transcutaneous PCO2 (PtCO2) compared to non-invasive ventilation  Long-Term Oxygen Therapy (LTOT) in patients with a Chronic obstructive pulmonary disease (COPD)-related hypercapnic respiratory failure.","other_id":"38R19.250","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosed with COPD (FEV1/FVC < 70%) and long term indication for home NIV for\r\n             initiated at least 3 months prior the inclusion.\r\n\r\n          -  Compliance with NIV (less than 5 hours and more than 1 hour) per night on average\r\n             during the last 3 months prior to inclusion.\r\n\r\n          -  Nave to Nasal High Flow (NHF) therapy, i.e. having not used NHF in the last 6 months\r\n             prior to inclusion.\r\n\r\n          -  Able to understand, follow objectives and methods of protocol in French language.\r\n\r\n          -  Patient affiliated to social security insurance or beneficiary of social health\r\n             insurance.\r\n\r\n          -  Willing and able to give written Informed Consent and to comply with the requirements\r\n             of the study protocol.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Significant uncontrolled cardiac disease (investigator judgment), and/or Left\r\n             Ventricular Ejection Fraction (LVEF) < 45%.\r\n\r\n          -  Known co-existing obstructive sleep apnea requiring expiratory pressure above 6 cmH20.\r\n\r\n          -  Severe nasal obstruction, previous upper airway surgery preventing the usage of NHF,\r\n             or, at the discretion of investigator, any other contraindication for using the NHF.\r\n\r\n          -  Patients who are unable or unwilling to give informed consent.\r\n\r\n          -  Participating in another research study.\r\n\r\n          -  Patient protected by the Law, under guardianship or curators.\r\n\r\n          -  Pregnancy and nursing mothers\r\n\r\n          -  Patient not covered by a health insurance.\r\n      ","sponsor":"University Hospital, Grenoble","sponsor_type":"Other","conditions":"Adherence, Treatment","interventions":[{"intervention_type":"Device","name":"Device: Nasal High Flow installation","description":"Participants randomized in NHF group will receive the nasal high flow (NHF) treatment delivered by myAirvo2.\r\nNasal High-Flow (NHF) is a treatment delivering heated, humidified, and optionally oxygen-enriched, air at high flow rates through a nasal cannula. The physiologic effects of NHF are an improvement in gas exchanges including a reduction in hypercarbia an optimization in breathing patterns with a reduction of work of breathing and high compliance as delivered via a comfortable nasal interface"},{"intervention_type":"Device","name":"Device: Non Invasive Ventilation","description":"Participants randomized in the Non Invasive Ventilation group will receive treatment as in their usual care."},{"intervention_type":"Other","name":"Other: Training session","description":"The patients in the Nasal High Flow (MyAirvo) arm will receive two hours training adaptation session in the hospital"},{"intervention_type":"Other","name":"Other: Education session","description":"Participants randomized in the Non Invasive Ventilation group will receive an additional educational session of one hour for improving compliance."}],"outcomes":[{"outcome_type":"primary","measure":"Changes on nocturnal parameters with the nasal high-flow (NHF) compared to non-invasive ventilation in patients with a COPD-related hypercapnic respiratory failure.","time_frame":"between night at day 1 (baseline) and night at day 90 (3 months after)","description":"Differences in mean overnight transcutaneous PtCO2 measurement"},{"outcome_type":"secondary","measure":"Evaluation the impact of nasal high-flow (NHF) on other nocturnal parameters compared to non-invasive ventilation ± LTOT compared to non-invasive ventilation in patients with a COPD-related hypercapnic respiratory failure.","time_frame":"between night at day 1 (baseline) and night at day 90 (3 months after)","description":"Maximum PtCO2"},{"outcome_type":"secondary","measure":"Treatment adherence","time_frame":"between night at day 1 (baseline) and night at day 90 (3 months after)","description":"Treatment adherence measured objectively by download of NIV software data and for NHF (myAirvo2) by hour meter & daily average of usage (screen display)"},{"outcome_type":"secondary","measure":"Daytime blood gas values in ambient air","time_frame":"between day 0 (inclusion) and day 97 (end of the study)","description":"PaCO2 & PaO2 in ambient air will be measured by blood gas sample in NHF group compared de NIV group"},{"outcome_type":"secondary","measure":"Other nocturnal parameter","time_frame":"between night at day 1 (baseline) and night at day 90 (3 months after)","description":"Overnight Sp02 will be evaluated by nocturnal oximetry at home in order to determine: mean nocturnal SaO2, nadir nocturnal SaO2, cumulative time spent below 90% of SaO2 (CT<90%), Oxygen Desaturation Index."},{"outcome_type":"secondary","measure":"Physical activity","time_frame":"for 7 days from the day 1 and for 7 days from the day 90","description":"An actimetry will allow evaluating physical activity (number of steps)"},{"outcome_type":"secondary","measure":"Sleep activity","time_frame":"between night at day 1 (baseline) and night at day 90 (3 months after)","description":"An actimetry will allow evaluating total sleep time in minutes"},{"outcome_type":"secondary","measure":"Sleep activity","time_frame":"between night at day 1 (baseline) and night at day 90 (3 months after)","description":"An actimetry will allow evaluating sleep onset latency in minutes"},{"outcome_type":"secondary","measure":"Sleep activity","time_frame":"between night at day 1 (baseline) and night at day 90 (3 months after)","description":"An actimetry will allow evaluating sleep efficiency"},{"outcome_type":"secondary","measure":"Pulmonary function tests","time_frame":"between day 0 and day 97","description":"Pulmonary function will be evaluated by routine patient care spirometry and will measure Vital capacity (VC) in liters"},{"outcome_type":"secondary","measure":"Pulmonary function tests","time_frame":"between day 0 and day 97","description":"Pulmonary function will be evaluated by routine patient care spirometry and will measure Forced vital capacity (FVC) in liters"},{"outcome_type":"secondary","measure":"Pulmonary function tests","time_frame":"between day 0 and day 97","description":"Pulmonary function will be evaluated by routine patient care spirometry and will measure Forced expiratory volume (FEV) in liters"},{"outcome_type":"secondary","measure":"Health related quality of life","time_frame":"between day 0 and day 97","description":"Subjective functioning and quality of life will be measured by self-reporting questionnaire EQ-5D-5L"},{"outcome_type":"secondary","measure":"Health related quality of life","time_frame":"between day 0 and day 97","description":"Subjective functioning and quality of life will be measured by self-reporting questionnaire SGRQ"},{"outcome_type":"secondary","measure":"Cardiovasculary function","time_frame":"between day 0 and day 97","description":"Blood pressure measurements will be done three times during rest at five minutes intervals to provide informations on systolic, diastolic and mean blood pressure"},{"outcome_type":"secondary","measure":"Number of participants with adverse events will be assessed in each group by interrogating patients in order to assess the safety of nasal high-flow (NHF) treatment","time_frame":"between day 0 and day 97","description":"All safety data will be recorded through an Electronic Medical Record as reported by the patient or recorded by the research nurse"}]}
{"nct_id":"NCT04404712","start_date":"2020-09-23","phase":"Early Phase 1","enrollment":100,"brief_title":"FAAH Availability in Psychiatric Disorders: A PET Study","official_title":"FAAH Availability in Psychiatric Disorders: A PET Study","primary_completion_date":"2023-08-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2024-08-01","last_update":"2021-01-11","description":"The aim of the present study is to examine Fatty Acid Amide Hydrolase (FAAH) availability in humans, including healthy individuals and across a spectrum of psychiatric disorders in which alterations in the endocannabinoid system are observed.","other_id":"2000027585","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Between the ages of 18 and 65 years, inclusive\r\n\r\n          -  Good physical health as determined by history, physical and laboratory examinations,\r\n             ECG, and vital signs\r\n\r\n        PTSD Inclusion Criteria:\r\n\r\n          -  Diagnosis of Post-Traumatic Stress Disorder\r\n\r\n        AUD Inclusion Criteria:\r\n\r\n          -  Diagnosis of Alcohol Use Disorder\r\n\r\n        Psychosis Inclusion Criteria:\r\n\r\n          -  Diagnosis of psychotic disorder such as Schizophrenia, Schizoaffective disorder\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Presence of ferromagnetic metal in the body or heart pacemaker\r\n\r\n          -  Women with a positive pregnancy test or women who are lactating\r\n      ","sponsor":"Yale University","sponsor_type":"Other","conditions":"Post Traumatic Stress Disorder|Alcohol Use Disorder|Psychosis","interventions":[{"intervention_type":"Drug","name":"Drug: [11C]MK-3168","description":"One PET scan involving administration of PET ligand [11C]MK-3168"}],"outcomes":[{"outcome_type":"primary","measure":"Total distribution of [11C]MK-3168 in the brain","time_frame":"PET scan day","description":"FAAH availability will be approximated using the FAAH positron emission tomography (PET) tracer [11C]MK-3168 total distribution"}]}
{"nct_id":"NCT04553471","start_date":"2020-09-22","phase":"N/A","enrollment":68,"brief_title":"Palliative Lattice Stereotactic Body Radiotherapy (SBRT) for Patients With Sarcoma, Thoracic, Abdominal, and Pelvic Cancers","official_title":"A Trial of Palliative Lattice Stereotactic Body Radiotherapy (SBRT) for Patients With Sarcoma, Thoracic, Abdominal, and Pelvic Cancers","primary_completion_date":"2022-08-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-01-31","last_update":"2021-09-17","description":"This is a study evaluating the safety and efficacy of Lattice SBRT for patients with large tumors ( 4.5 cm) planning to undergo palliative radiotherapy.","other_id":"202009022","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"At least 10 participants will be enrolled in each cohort (soft tissue sarcomas, thoracic cancers, abdominal, and pelvic cancers).","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically or cytologically confirmed sarcoma (including extremity), thoracic\r\n             cancer (including esophageal), abdominal cancer (including retroperitoneal sarcoma),\r\n             or pelvic cancer.\r\n\r\n          -  Planning to undergo palliative radiotherapy to a lesion  4.5 cm as measured with\r\n             radiographic imaging or with calipers by clinical exam.\r\n\r\n          -  ECOG performance status  2\r\n\r\n          -  At least 18 years of age.\r\n\r\n          -  Radiotherapy is known to be teratogenic. For this reason, women of childbearing\r\n             potential and men must agree to use adequate contraception (hormonal or barrier method\r\n             of birth control, abstinence) prior to study entry and for the duration of study\r\n             participation. Should a woman become pregnant or suspect she is pregnant while\r\n             participating in this study, she must inform her treating physician immediately. Men\r\n             treated or enrolled on this protocol must also agree to use adequate contraception\r\n             prior to the study, for the duration of the study, and 6 months after completion of\r\n             the study\r\n\r\n          -  Ability to understand and willingness to sign an IRB approved written informed consent\r\n             document\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior high-dose radiotherapy that overlaps with any planned site of protocol\r\n             radiotherapy. Patients where the Lattice SBRT fields may overlap with the low dose\r\n             (<10 Gy) region of prior radiotherapy treatments are eligible and may be treated if\r\n             this is determined to be safe by the treating physician.\r\n\r\n          -  Patients with tumors in need of urgent surgical intervention, such as life-threatening\r\n             bleeding or those at high risk for pathologic fracture.\r\n\r\n          -  Currently receiving any cytotoxic cancer therapy regimens or VEGF inhibitors that will\r\n             overlap with the Lattice SBRT administration.\r\n\r\n             *Cytotoxic chemotherapy and VEGF inhibitors prior to radiotherapy or planned after\r\n             radiotherapy delivery are allowed at the discretion of the treating radiation\r\n             oncologist. This includes continuing a treatment plan which was initiated prior to the\r\n             start of radiotherapy. A 2-week washout is recommended, but not required.\r\n\r\n          -  Pregnant. Women of childbearing potential must have a negative pregnancy test within\r\n             20 days of study entry.\r\n\r\n          -  Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or\r\n             they have a history of AIDS-defining opportunistic infection within the 12 months\r\n             prior to registration. Concurrent treatment with effective ART according to DHHS\r\n             treatment guidelines is recommended. Recommend exclusion of specific ART agents based\r\n             on predicted drug-drug interactions (i.e. for sensitive CYP3A4 substrates, concurrent\r\n             strong CYP3A4 inhibitors (ritonavir and cobicistat) or inducers (efavirenz) should be\r\n             contraindicated).\r\n      ","sponsor":"Washington University School of Medicine","sponsor_type":"Other","conditions":"Sarcoma|Thoracic Cancer|Abdominal Cancer|Pelvic Cancer","interventions":[{"intervention_type":"Radiation","name":"Radiation: Stereotactic body radiotherapy","description":"Treatment will take approximately 2 weeks."},{"intervention_type":"Procedure","name":"Procedure: Research blood draw","description":"-Baseline, immediately after radiotherapy completion (fraction 5), 14 days after radiotherapy, and 30 day follow-up"}],"outcomes":[{"outcome_type":"primary","measure":"Rate of local control","time_frame":"6 months"},{"outcome_type":"primary","measure":"Proportion of participants with treatment-related grade 3 or higher CTCAE v5.0 toxicity","time_frame":"Within 6 months of completion of treatment (estimated to be 6 months and 2 weeks)"},{"outcome_type":"secondary","measure":"Proportion of participants with treatment-related grade 3 or higher CTCAE v5.0 toxicity","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Patient reported toxicity as measured by PRO-CTCAE assessment","time_frame":"Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months","description":"-The PRO-CTCAE Measurement System characterizes the frequency, severity, interference, and presence/absence of symptomatic toxicities"},{"outcome_type":"secondary","measure":"Quality of life as measured by PROMIS physical function assessment","time_frame":"Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months","description":"10-item questionnaire assessing current self-reported physical function\r\nAnswers range from 1-cannot do to 5=not at all/without any difficulty\r\nScore ranges from 10-50 with a higher score indicating better physical function"},{"outcome_type":"secondary","measure":"Quality of life as measured by PROMIS global health physical assessment","time_frame":"Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months","description":"2-item questionnaire assessing current self-reported overall physical function\r\nAnswers range from 1=poor/not all all to 5=excellent/completely\r\nScore ranges from 2-10 with a higher score indicating better global health physical function"},{"outcome_type":"secondary","measure":"Quality of life as measured by PROMIS anxiety assessment","time_frame":"Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months","description":"29-item questionnaire assessing current self-reported anxiety\r\nAnswers range from 1-never to 5=always\r\nScore ranges from 29-145 with a lower score indicating less anxiety"},{"outcome_type":"secondary","measure":"Quality of life as measured by PROMIS depression assessment","time_frame":"Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months","description":"4-item questionnaire assessing current self-reported depression\r\nAnswers range from 1=never to 5=always\r\nScore ranges from 4-20 with a lower score indicating less depression"},{"outcome_type":"secondary","measure":"Patient reported pain as measured by Numeric Pain Scale","time_frame":"Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months","description":"-The Numeric Pain Scale is an 11-point scale for patient self-reporting of pain"}]}
{"nct_id":"NCT04420520","start_date":"2020-09-20","enrollment":135,"brief_title":"Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children in Fayoum Governorate Schools","official_title":"Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children in Fayoum Governorate Schools: A Cross Sectional Study","primary_completion_date":"2021-04-20","study_type":"Observational [Patient Registry]","rec_status":"Not yet recruiting","completion_date":"2021-05-20","last_update":"2020-06-09","description":"Determining the Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children in Fayoum Governorate Schools via clinical examination. Participants from primary and preparatory schools in Fayoum governorate will be included in the study and Clinical examination will be carried out in the school laboratory or an empty class, in day light for both genders. Teeth will be cleaned gently using gauze and wet with saliva during examination. A disposable diagnostic set (mirror, probe) will be used for each patient where mirrors will be used for proper visualization especially for maxillary teeth. Blunt explorers will be used to aid in tactile sensation if needed, as during the differentiation between rough and smooth enamel edges and/or during the inspection of the caries extent if it exists. No diagnostic radiographs will be taken. The results of the study will be regularly monitored by the supervisors who will have full access to these results.","other_id":"CEBD-CU-2020-05-13","observational_model":"Cohort","time_perspective":"Cross-Sectional","sampling_method":"Probability Sample","gender":"All","minimum_age":6,"maximum_age":14,"population":"Egyptian children in Fayoum governorate schools.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Acceptance for participation in the study.\r\n\r\n          -  Eruption of four first permanent molars.\r\n\r\n          -  Eruption of four permanent maxillary and mandibular incisors.\r\n\r\n          -  Both genders.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Uncooperative children.\r\n\r\n          -  Children with orthodontic appliances.\r\n\r\n          -  Children with systemic diseases which may affect teeth development.\r\n\r\n          -  Children suffering from any other type of enamel defect as enamel hypoplasia and\r\n             amelogenesis imperfecta.\r\n      ","sponsor":"Cairo University","sponsor_type":"Other","conditions":"Molar Incisor Hypomineralization","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Prevalence of Molar Incisor Hypomineralization","time_frame":"Through study completion, an average of 1 year","description":"Prevalence of Molar Incisor Hypomineralization done via clinical examination using a disposable diagnostic set in the school laboratory or an empty class, in day light."}]}
{"nct_id":"NCT04567810","start_date":"2020-09-18","phase":"Phase 1","enrollment":48,"brief_title":"Safety, Tolerability, and Pharmacokinetics of Anti-Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Chicken Egg Antibody (IgY) (COVID-19)","official_title":"A Phase 1 Study in Healthy Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single -Ascending and Multiple Doses of an Anti-Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Chicken Egg Antibody (IgY)","primary_completion_date":"2020-12-14","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-12-14","last_update":"2021-09-20","description":"The primary objective of Part 1 (Single Ascending Dose) is to assess the safety and tolerability of anti-SARS-CoV-2 IgY when given as single-ascending doses administered intranasally to healthy participants. The primary objective of Part 2 (Multiple Dose) is to assess the safety and tolerability of anti-SARS-CoV-2 IgY when given as multiple doses administered intranasally to healthy participants. A secondary objective is to assess the pharmacokinetics of anti-SARS-CoV-2 IgY when given as multiple doses administered intranasally to healthy participants. Safety will be evaluated using adverse event (AE), physical examination (including vital signs), electrocardiogram, and clinical laboratory data. Pharmacokinetics will be evaluated by serum anti-SARS-CoV-2 IgY concentration.","other_id":"CVR001","allocation":"Randomized","intervention_model":"Sequential Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy males or non-pregnant, non-lactating females\r\n\r\n          -  Body weight of at least 50 kg\r\n\r\n          -  Good state of health (mentally and physically)\r\n\r\n          -  Must agree to use of highly effective method of contraception\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Received other investigational drug within the last 30 days prior to screening\r\n\r\n          -  History of drug or alcohol abuse in the past 2 years (>21 units of alcohol per week\r\n             for males and >14 units of alcohol per week for females)\r\n\r\n          -  Current smoker / e-smoker\r\n\r\n          -  Abnormal kidney function\r\n\r\n          -  Abnormal liver function\r\n\r\n          -  Positive for hepatitis B or C infection\r\n\r\n          -  Positive for HIV infection\r\n\r\n          -  Positive for SARS-CoV-2 infection\r\n\r\n          -  History of egg allergy\r\n\r\n          -  Abnormal cardiac function\r\n      ","sponsor":"Stanford University","sponsor_type":"Other","conditions":"Covid19","interventions":[{"intervention_type":"Drug","name":"Drug: anti-SARS-CoV-2 IgY","description":"anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo matching anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper."}],"outcomes":[{"outcome_type":"primary","measure":"Number of participants with treatment-related adverse events","time_frame":"up to 21 days"},{"outcome_type":"secondary","measure":"Number of Participants With Vital Sign Findings Reported as TEAEs","time_frame":"up to 21 days"},{"outcome_type":"secondary","measure":"Number of Participants With Clinically Significant Findings in Physical Examinations","time_frame":"up to 21 days","description":"Clinically significant in the judgement of the investigator."},{"outcome_type":"secondary","measure":"Number of Participants With Clinically Significant Changes From Baseline in ECG Data","time_frame":"up to 21 days","description":"Clinically significant in the judgement of the investigator."},{"outcome_type":"secondary","measure":"Number of participants with Clinically Significant Changes from Baseline in Clinical Laboratory Parameters","time_frame":"up to 21 days","description":"Clinically significant in the judgement of the investigator."},{"outcome_type":"secondary","measure":"Number of Participants with Presence of Serum anti-SARS-CoV-2 IgY","time_frame":"up to 21 days"}]}
{"nct_id":"NCT04464434","start_date":"2020-09-17","phase":"Phase 3","enrollment":120,"brief_title":"Upfront Autologous HSCT Versus Immunosuppression in Early Diffuse Cutaneous Systemic Sclerosis","official_title":"Upfront Autologous Hematopoietic Stem Cell Transplantation Versus Immunosuppressive Medication in Early Diffuse Cutaneous Systemic Sclerosis: an International Multicentre, Open-label, Randomized Con-trolled Trial","primary_completion_date":"2025-09-17","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2026-02-01","last_update":"2021-04-08","description":"HSCT has been implemented in (inter)national treatment guidelines for diffuse cutaneous systemic sclerosis (dcSSc) and is offered in clinical care and reimbursed by national health insurance in several European countries. However, data and specific guidelines on the best timing of HSCT in the course of dcSSc are lacking. In particular, it is unclear whether HSCT should be positioned as upfront therapy or as rescue treatment for patients not responding to conventional immunosuppressive therapy. This multicentre, randomized, open label trial aims to compare two treatment strategies used in usual care: upfront autologous HSCT versus usual care with (intravenous (i.v.) cyclophosphamide (CYC) pulse therapy followed by mycophenolate mofetil (MMF) and HSCT as rescue option).","other_id":"NL72607.041.20","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"This multicentre, randomized, open label trial aims to compare two treatment strategies in early dcSSc: upfront autologous HSCT versus i.v. CYC pulse therapy followed by MMF and HSCT as rescue option.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age between 18 and 65 years.\r\n\r\n          2. Fulfilling the 2013 ACR-EULAR classification criteria for SSc (appendix B).\r\n\r\n          3. Disease duration  2 years (from onset of first non-Raynaud's symptoms) and diffuse\r\n             cutaneous disease with\r\n\r\n               -  mRSS  15 and/or\r\n\r\n               -  clinically significant organ involvement as defined by either:\r\n\r\n                    1. respiratory involvement = i. DLCO and/or (F)VC  85% (of predicted) and\r\n                       evidence of interstitial lung disease on HR-CT scan with clinically relevant\r\n                       obstructive disease and emphysema excluded.\r\n\r\n                       ii. Patients with a DCLO and/or FVC > 85%, but with a progressive course of\r\n                       lung disease: defined as relative decline of >10% in FVC predicted and/or\r\n                       TLC predicted, or >15% in DLCO predicted and evidence of interstitial lung\r\n                       disease on HR-CT scan with clinically relevant obstructive disease and\r\n                       emphysema excluded, within 12 months. Intercurrent infections excluded.\r\n\r\n                    2. renal involvement = any of the following criteria: hypertension (two\r\n                       successive BP readings of either systolic  160 mm Hg or diastolic > 110 mm\r\n                       Hg, at least 12 hours apart), persistent urinalysis abnormalities\r\n                       (proteinuria, haematuria, casts), microangiopathic haemolytic anaemia, new\r\n                       renal insufficiency (serum creatinine > upper limit of normal);\r\n                       non-scleroderma related causes (e.g. medication, infection etc.) must be\r\n                       reasonably excluded.\r\n\r\n                    3. cardiac involvement = any of the following criteria: reversible congestive\r\n                       heart failure, atrial or ventricular rhythm disturbances such as atrial\r\n                       fibrillation or flutter, atrial paroxysmal tachycardia or ventricular\r\n                       tachycardia, 2nd or 3rd degree AV block, pericardial effusion (not leading\r\n                       to hemodynamic problems), myocardi-tis; non-scleroderma related causes must\r\n                       have been reasonably excluded.\r\n\r\n          4. Written Informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Pregnancy or unwillingness to use adequate contraception during study\r\n\r\n          2. Concomitant severe disease =\r\n\r\n               1. respiratory: resting mean pulmonary artery pressure (mPAP) > 20 mmHg (by right\r\n                  heart catheterisation), DLCO < 40% predicted, respiratory failure as defined by\r\n                  the primary endpoint\r\n\r\n               2. renal: creatinine clearance < 40 ml/min (measured or estimated)\r\n\r\n               3. cardiac: clinical evidence of refractory congestive heart failure; LVEF < 45% by\r\n                  cardiac echo or cardiac MR; chronic atrial fibrillation necessitating oral\r\n                  anticoagulation; uncontrolled ventricular arrhythmia; pericardial effusion with\r\n                  hemodynamic consequences\r\n\r\n               4. liver failure as defined by a sustained 3-fold increase in serum transaminase or\r\n                  bilirubin, or a Child-Pugh score C\r\n\r\n               5. psychiatric disorders including active drug or alcohol abuse\r\n\r\n               6. concurrent neoplasms or myelodysplasia\r\n\r\n               7. bone marrow insufficiency defined as leukocytopenia < 4.0 x 109/L,\r\n                  thrombocytopenia < 50x 10^9/L, anaemia < 8 gr/dL, CD4+ T lymphopenia < 200 x\r\n                  106/L\r\n\r\n               8. uncontrolled hypertension\r\n\r\n               9. uncontrolled acute or chronic infection, including HIV, HTLV-1,2 positivity\r\n\r\n              10. ZUBROD-ECOG-WHO Performance Status Scale > 2\r\n\r\n          3. Previous treatments with immunosuppressants > 6 months including MMF, methotrexate,\r\n             azathioprine, rituximab, tocilizumab, glucocorticosteroids.\r\n\r\n          4. Previous treatments with TLI, TBI or alkylating agents including CYC.\r\n\r\n          5. Significant exposure to bleomycin, tainted rapeseed oil, vinyl chloride,\r\n             trichlorethylene or silica;\r\n\r\n          6. eosinophilic myalgia syndrome; eosinophilic fasciitis.\r\n\r\n          7. Poor compliance of the patient as assessed by the referring physicians.\r\n      ","sponsor":"UMC Utrecht","sponsor_type":"Other","conditions":"Systemic Sclerosis|Systemic Scleroses, Diffuse|Scleroderma|Scleroderma, Diffuse|Autologous Stem Cell Transplantation|Cyclophosphamide|Mycophenolate Mofetil|Treatment Strategy","interventions":[{"intervention_type":"Procedure","name":"Procedure: Upfront autologous HSCT","description":"HSCT comprises the following consecutive steps:\r\nMobilisation\r\nInfusions of CYC 2g/m2 on 1 day.\r\nHyperhydration, alkalinisation of urine and mesna to prevent haemorrhagic cystitis.\r\nFilgrastim (G-CSF) 5-10 g/kg/day subcutaneously for 5 days (or more when necessary).\r\nLeukapheresis Prompt start of leukapheresis is required at a CD34+ cell count of 10-20/L. Goal: at least 2 x 10^6 CD34+ cells per kilogram body weight.\r\nConditioning\r\nCYC 50 mg/kg/day intravenously for 4 consecutive days (total 200 mg/kg)\r\nRabbit Antithymocyte Globulin (rbATG), a total dose of 7.5 mg/kg i.v., from Genzyme.\r\nHyperhydration, alkalinisation of the urine and mesna will be given to prevent haemorrhagic cystitis.\r\nI.v. methylprednisolone 2 mg/kg will be administered on the days ATG, to improve tolerability of the ATG.\r\nPeripheral stem cell infusion The number of CD34+ cells to be reinfused should be  2.0 x 10^6/kg."}],"outcomes":[{"outcome_type":"primary","measure":"Number of patients who survive without major events (event free survival)","time_frame":"24 months","description":"Event-free survival is defined as the time in days from the day of randomisation until the occurrence of death due to any cause or the development of persistent major organ failure (heart, lung, kidney) defined as follows:\r\nHeart: left ventricular ejection fraction < 30% by cardiac MR (or cardiac echo)\r\nLungs: respiratory failure = resting arterial oxygen tension (PaO2) < 8 kPa (< 60 mmHg) and/or resting arterial carbon dioxide tension (PaCO2) > 6.7 kPa (> 50 mmHg) without oxygen supply\r\nKidney: need for renal replacement therapy"},{"outcome_type":"secondary","measure":"Number of patients who survive without disease progression (Progression-free survival)","time_frame":"24 months","description":"Defined as the time in days since the day of randomisation until any of the following relative changes from base-line has been documented:\r\ndeath,\r\n≥ 10% drop in (F)VC predicted and/or ≥ 15% drop in DLCO predicted,\r\n≥ 15% drop in LVEF by echo or cardiac MR,\r\n≥ 15% drop in body weight,\r\n≥ 30% drop in creatinine clearance,\r\n≥ 30% increase in skin score,\r\n≥ 0.5 increase in SHAQ."},{"outcome_type":"secondary","measure":"Number of patients who die due to complications related to the treatment (Treatment related mortality)","time_frame":"24 months","description":"Defined as any death during the study period following randomisation that cannot be attributed to progression of the disease according to the consensus opinion of the DSMB."},{"outcome_type":"secondary","measure":"Number of patient alive after 24 months (Overall mortality)","time_frame":"24 months","description":"Any death, regardless of relationship to treatment, between randomization and 24 months post-randomization"},{"outcome_type":"secondary","measure":"Number of CTCAE toxicity advserse events","time_frame":"24 months","description":"Number of CTCAE v5.0 toxicity advserse events =/> grade 3 that occur in consecutive 3-month periods following randomisation until 24 months follow-up."},{"outcome_type":"secondary","measure":"The area under the curve (AUC) of the CRISS over time","time_frame":"24 months","description":"The American College of Rheumatology Composite Response Index in Diffuse Cutaneous Systemic Sclerosis (ACR CRISS) was developed using expert consensus and data driven approaches for use in clinical trials (Khanna et al, 2016).\r\nThe exponential algorithm determines the predicted probability of improvement from baseline, incorporating change in the mRSS, FVC percent predicted, physician and patient global assessments, and HAQ-DI. The outcome is a continuous variable between 0.0 and 1.0 (0 - 100%). A higher score indicates greater improvement. Subjects are not considered improved (ACR CRISS score = 0) if they develop new: 1) renal crisis; 2) decline in FVC% predicted by 15% (relative) from baseline and confirmed after 1 month; or 3) left ventricular failure (systolic ejection fraction < 45%); or 4) new pulmonary artery hypertension on right heart catheterization requiring treatment."},{"outcome_type":"secondary","measure":"Changes in skin involvement (modified Rodnan Skin Score)","time_frame":"24 months","description":"Modified Rodnan Skin Score (mRSS) The MRSS is a validated physical examination method for estimating skin induration. It is correlated with biopsy measures of skin thickness and reflects prognosis and visceral involvement, especially in early disease2, 4. It is scored on a 0 (normal) to 3+ (severe induration) ordinal scales over 17 body areas, with a maximum score of 51 and is used to categorize severity of SSc. Minimally clinically significant difference in MRSS is 3-5 points (Amjadi et al., American College of Rheumatology; Aug 2009; 2493-2494) It has been extensively used as primary/ secondary outcome in RCT with Scleroderma. This will be collected at every study visit."},{"outcome_type":"secondary","measure":"Changes in cardiac function(Left Ventricular Ejection Fraction)","time_frame":"12 and 24 months","description":"LVEF is measured by cardiac echo and at baseline and 12 months with cardiac MRI."},{"outcome_type":"secondary","measure":"Changes in pulmonary function","time_frame":"12 and 24 months","description":"Diffusion in liters of carbon monoxide (DLCO) is a measure of lung function. Predicted values for DLCO were computed using the Crapo Morris equations and adjusted per the Cotes formula for anemia, if a participant's hemoglobin was <13 or >17 gm/dL, and altitude (Calgary site only). Forced Vital Capacity (FVC) is the amount of air that can be forcibly exhaled after a full breath and is a measure of lung function. Predicted FVC was based on institutional standards."},{"outcome_type":"secondary","measure":"Changes in health related quality of life EQ-5D-5L index","time_frame":"24 months","description":"HR-QoL will be assessed using the validated EuroQol (EQ-5D-5L), the calculated index ranges from 0 (worse HR-QoL) to 1 (best HR-QoL)."},{"outcome_type":"secondary","measure":"Changes in nailfold capillaroscopy","time_frame":"12 and 24 months","description":"Nailfold capillaroscopy (NFS) will be obtained by the local capillaroscopist pre- and post-ASCT (at baseline, at 6, 12 24 months and yearly after). The evaluation of the images will be done centrally. The NFS-findings will be described standardly according to the consensus of the EULAR study group on microcirculation in rheumatic diseases. As such, the images will be evaluated in a quantitative (density, di-mension, morphology and presence of haemorrhages) and a qualitative way (normal, aspecific abnormalities, early/active/late scleroderma pattern). As we will analyse 16 NFS-images per subject, an overall qualitative as-sessment per subject will be assigned, based on the most prevalent pattern per subject."},{"outcome_type":"secondary","measure":"Changes in 18F FDG-PET scan from the thorax","time_frame":"12 months","description":"Validation of semi-quantitative analysis method with respiratory gated and non-gated 18F FDG-PET prospec-tively and comparison of 18F FDG-PET with routine HR-CT thorax, pulmonary lung function and clinical symptoms, will be done at baseline and at 12 months follow-up."},{"outcome_type":"secondary","measure":"Changes in gastrointestinal complaints (UCLA SCTC GIT 2.0)","time_frame":"12 and 24 months","description":"The UCLA SCTC GIT 2.0 is a standardized set of outcome measures developed through literature review, patient focus groups and cognitive debriefing among patients with a variety of gastrointestinal disorders including irritable bowel syndrome, inflammatory bowel disease, other common gastrointestinal disorders, SSc, and a census-based US general population control sample (Khanna et al, 2009). The scale consists of eight domains relating to gastroesophageal reflux (13 items), disrupted swallowing (7 items), diarrhea (5 items), bowel incontinence/soilage (4 items), nausea and vomiting (4 items), constipation (9 items), belly pain (6 items), and gas/bloat/flatulence (12 items). The scales correlated significantly with both generic and disease-targeted legacy instruments, and demonstrate evidence of reliability."},{"outcome_type":"secondary","measure":"Changes in several subsets of the immune system","time_frame":"12 months","description":"We will evaluate antibody repertoire pre- and post-treatment at dedicated timepoints and assess correlations to clinical disease course characteristics. Also, B cells will be characterized in terms of frequency, phenotype and functional capacities before and after treatment. Additionally, transcriptomics analysis on the immune cell (sub-)populations isolated will be done."},{"outcome_type":"secondary","measure":"Changes in self-assessed skin thickness (PASTUL_)","time_frame":"60 months","description":"Patients will assess their skin thickness using the validate PASTUL questionnaire every 3 months."},{"outcome_type":"secondary","measure":"Inflammatory and fibrotic characteristics and changes of the skin and composition of the microbiome of the skin","time_frame":"12 months","description":"Skin biopsies from affected skin will be used to investigate the inflammatory and fibrotic changes and the skin microbiome. Before taking the skin biopsies the skin will be anesthetized with lidocaine 1%. The biopsy used for analysis of the inflammatory and fibrotic characteristics, using immunohistochemistry, will be frozen in liquid nitrogen. 6S rRNA gene sequencing will be done to obtain the microbial profiles of the skin biopsies."},{"outcome_type":"secondary","measure":"Changes in sexual functioning","time_frame":"12 and 24 months","description":"We will use the validated IIEF-5 and SFQ-28"},{"outcome_type":"secondary","measure":"Changes in daily functioning","time_frame":"12 and 24 months","description":"SHAQ-DI The SHAQ-DI is a disease-targeted, musculoskeletal-targeted measure intended for assessing functional ability in scleroderma. It is a self-administered 20-question instrument that assesses a patient's level of functional ability and includes questions that involve both upper and lower extremities. The SHAQ-DI score ranges from 0 (no disability) to 3 (severe disability). It has a 7 day recall period and has been extensively used in SSc. Five visual analog scales are included in the scleroderma-HAQ assessing burden of digital ulcers, Raynaud's, gastrointestinal involvement, breathing, and overall disease."},{"outcome_type":"secondary","measure":"Changes in ability to work, measured by the customized Productivity Cost Questionnaire (iPCQ)","time_frame":"12 and 24 months","description":"The customized iPCQ is a selection of 5 questions derived from the full iPCQ"},{"outcome_type":"secondary","measure":"Changes in fatigue measured with the FACIT questionnaire","time_frame":"12 and 24 months","description":"The FACIT questionnaire is a validated questionnaire for evaluating fatigue"},{"outcome_type":"secondary","measure":"Changes in handmobility","time_frame":"24 months","description":"assessment done using the mHAMIS"}]}
{"nct_id":"NCT03982316","start_date":"2020-09-15","phase":"N/A","enrollment":20,"brief_title":"Telehealth Behavioral Migraine Management","official_title":"Telehealth Behavioral Migraine Management","primary_completion_date":"2022-05-13","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-08-15","last_update":"2021-06-01","description":"This project aims to develop the protocol and obtain feasibility and acceptability information for Telehealth Behavioral MIgraine Management in a single-arm pre-post pilot study. I aim recruit 20 people with migraine from the Montefiore Headache Center in the Bronx NY. Participants will receive the 12-week protocol including a mobile app headache diary, an online patient manual with interactive vignettes, 4 50-minute telehealth sessions, and 3 15-minute check-ins.","other_id":"2019-10345","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Physician diagnosis of migraine\r\n\r\n          -  Current self-reported symptoms meeting the International Classification for Headache\r\n             Disorders -- 3 criteria for migraine\r\n\r\n          -  Self-reported between 4 and 20 headache days/month\r\n\r\n          -  Aged 18-65\r\n\r\n          -  Can read English\r\n\r\n          -  Capacity to consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Psychiatric illness that would interfere with study participation\r\n\r\n          -  Meeting criteria for probable medication overuse headache\r\n      ","sponsor":"Albert Einstein College of Medicine","sponsor_type":"Other","conditions":"Migraine","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Telehealth Behavioral Migraine Management","description":"1) Weekly online modules; 2) Monthly 50 minute telephone calls; 3) 3 15-minute telephone check ins."}],"outcomes":[{"outcome_type":"primary","measure":"Feasibility of TeleBMM","time_frame":"Week 0 through Week 12","description":"Number of treatment components participants complete (out of 20)"},{"outcome_type":"secondary","measure":"Patient-rated satisfaction","time_frame":"Post-treatment survey at Week 12","description":"Patient-rated satisfaction (acceptability) with the program on a Likert-type scale ranging from 0 (\"Not at all satisfied\") to 4 (\"Very satisfied\")"},{"outcome_type":"secondary","measure":"Quality of Life (Migraine Specific)","time_frame":"Change from Pre-treatment (Week 0) to Post-treatment (Week 12)","description":"Score on the MSQ v 2.1, a 14-item survey assessing quality of life in people with migraine."},{"outcome_type":"secondary","measure":"Headache frequency","time_frame":"Slope change from Week 0 to Week 12","description":"Participants complete a daily headache diary, on which each 7 day week they denote whether they have had a headache attack."}]}
{"nct_id":"NCT04574570","start_date":"2020-09-14","phase":"N/A","enrollment":25,"brief_title":"TOKA: Custom Made Devices for High Tibial Osteotomy (HTO) - Clinical Investigation","official_title":"Clinical Evaluations of the TOKA Customized Device for High Tibial Osteotomy in the Treatment of Knee Osteoarthritis: a Pilot Study.","primary_completion_date":"2021-05-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-11-29","last_update":"2021-01-13","description":"This preliminary pilot study is a single-centre, prospective, uncontrolled, 32-month study to assess the performance of personalised opening wedge High Tibial Osteotomy (HTO) treatment using the TOKA device and procedure. The medical device being examined is a custom-made device and therefore does not require a CE mark. Furthermore, the study will serve as a useful method of gathering clinical data and measuring device performance, as well as establishing a potential commercial relationship with the hospital administration. Study Objectives:: 1. to assess the morphology of the knee joint and the improvement of OA following the TOKA treatment. 2. to Assess the functional outcome of the knee joint and the improvement of OA following the TOKA treatment. Outcomes Evaluations:: 1. The morphology of the knee joint is assessed by verifying the matching between the planned correction and the post-operative imaging results, along with the investigation of the maintenance of the desired correction at the follow-up meetings. These results are measured through the correction angle, hip-knee-ankle angle (HKA - mechanical axis), Mikulicz point (recorded as a percentage of the tibial width from the medial to the lateral region) and posterior slope, using the imaging techniques. 2. The functional outcome of the knee joint is assessed by a) performing a gait analysis of the patients pre-operatively and post-operatively, b) the use of clinical scoring... .","other_id":"CE-AVEC 623/2019 DISP/IOR TOKA","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":40,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients undergoing opening wedge Hight Tibial Osteotomy (HTO)\r\n\r\n          -  Patients must have completed a consent form for the study\r\n\r\n          -  Patients must be prepared to comply with the pre and post-operative investigations,\r\n             rehabilitation, attendance schedule and questionnaire schedule of the study\r\n\r\n          -  Patient in whom any varus deformity present is <20\r\n\r\n          -  The diagnosis is of unicompartmental medial osteoarthritis of the knee\r\n\r\n          -  Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD)\r\n\r\n          -  BMI<40\r\n\r\n          -  Age range 40 to 65 years\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Refusal to consent to the study\r\n\r\n          -  Pregnancy\r\n\r\n          -  Prisoners\r\n\r\n          -  A patient known to have substance abuse or psychological disorders that could\r\n             interfere with their ability to comply with the post-operative rehabilitation and\r\n             assessment schedules\r\n\r\n          -  Patients unable to read or understand the patient information leaflet and consent form\r\n\r\n          -  Patient has a known sensitivity to device materials.\r\n\r\n          -  Patient has a Body Mass Index (BMI)  40.\r\n\r\n          -  Patient has an active or suspected latent infection in or about the affected knee\r\n             joint at time of study device implantation.\r\n\r\n          -  Patient has received any orthopaedic surgical intervention to the lower extremities\r\n             within the past year or is expected to require any orthopaedic surgical intervention\r\n             to the lower extremities, other than the HTO to be enrolled in this study, within the\r\n             next year.\r\n\r\n          -  Patient requires bilateral HTO or has a history of unsuccessful contralateral partial\r\n             replacement or HTO.\r\n\r\n          -  Patient has chronic heart failure (NYHA Stage  2)\r\n\r\n          -  Patient has a neuromuscular or neurosensory deficiency, which limits the ability to\r\n             evaluate the safety and efficacy of the device.\r\n\r\n          -  Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic\r\n             disorder (e.g. Paget's disease) leading to progressive bone deterioration.\r\n\r\n          -  Patient is immunologically suppressed or receiving steroids in excess of normal\r\n             physiological requirements (e.g. > 30 days).\r\n      ","sponsor":"3D Metal Printing Ltd","sponsor_type":"Industry","conditions":"Unicompartmental Medial Knee Osteoarthritis","interventions":[{"intervention_type":"Device","name":"Device: High Tibial Osteotomy","description":"Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA)"}],"outcomes":[{"outcome_type":"primary","measure":"Morphology Assessment via correction angle assessment","time_frame":"At 6 months after surgery","description":"The device morphology assessment is performed by verifying the matching between the planned correction and the post-operative imaging results, along with the investigation of the maintenance of the desired correction at the follow-up meetings. These results are measured through the correction angle, using image-based techniques."},{"outcome_type":"primary","measure":"Morphology Assessment via hip-knee-ankle angle assessment","time_frame":"At 6 months after surgery","description":"The device morphology assessment is performed by verifying the matching between the planned correction and the post-operative imaging results, along with the investigation of the maintenance of the desired correction at the follow-up meetings. These results are measured through the hip-knee-ankle angle (HKA - mechanical axis) reported in degree, using image-based techniques."},{"outcome_type":"primary","measure":"Morphology Assessment via Mikulicz point assessment","time_frame":"At 6 months after surgery","description":"The device morphology assessment is performed by verifying the matching between the planned correction and the post-operative imaging results, along with the investigation of the maintenance of the desired correction at the follow-up meetings. These results are measured through the Mikulicz point reported in % of the tibial width from the medial to the lateral region, using image-based techniques."},{"outcome_type":"primary","measure":"Morphology Assessment via posterior slope assessment","time_frame":"At 6 months after surgery","description":"The device morphology assessment is performed by verifying the matching between the planned correction and the post-operative imaging results, along with the investigation of the maintenance of the desired correction at the follow-up meetings. These results are measured through the posterior slope reported in degree, using image-based techniques."},{"outcome_type":"secondary","measure":"Functional Assessment via gait analysis - kinematics","time_frame":"Before surgery and at 6 months after surgery","description":"The functional assessment is performed via three dimensional gait analysis of the patients before and after surgery. Relevant kinematic results are reported in terms of joint rotations (in degrees).."},{"outcome_type":"secondary","measure":"Functional Assessment via gait analysis - kinetics","time_frame":"Before surgery and at 6 months after surgery","description":"The functional assessment is performed via three dimensional gait analysis of the patients before and after surgery. Relevant kinematic results are reported in terms of joint moments (in N*mm, normalized to patient's body weight times height)."},{"outcome_type":"secondary","measure":"Functional Assessment via clinical scoring - Knee Osteoarthritis Outcome Score","time_frame":"Before surgery and at 1, 3, 6, 12 and 24 months after surgery.","description":"The functional assessment is performed via clinical scoring using the Knee Osteoarthritis Outcome Score (KOOS). KOOS value range: [min / max]= 0 - 100, higher values mean better outcome."},{"outcome_type":"secondary","measure":"Functional Assessment via clinical scoring - European Quality of life via 5-Dimensions questionnaire","time_frame":"Before surgery and at 1, 3, 6, 12 and 24 months after surgery.","description":"The functional assessment is performed via clinical scoring using the European Quality of life via 5-Dimensions questionnaire (EQ-5D). In applied EQ-5D, the respondents classify their own health status into 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with 3 levels of severity (no problems, moderate problems, or severe problems. Based on that, patients could be classified into 243 health states and 2 additional states (unconscious and dead). The EQ-5D health states are converted into a single summary score by applying weights to each of the levels in each dimension, as is typically done in cost utility analysis. Health state index scores range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility."},{"outcome_type":"secondary","measure":"Functional Assessment via clinical scoring - Tegner score","time_frame":"Before surgery and at 1, 3, 6, 12 and 24 months after surgery.","description":"The functional assessment is performed via clinical scoring using the Tegner score. Tegner scale value range: [min / max]= 0 - 10, higher values mean better outcome."},{"outcome_type":"secondary","measure":"Functional Assessment via clinical scoring - Knee Society System Score","time_frame":"Before surgery and at 1, 3, 6, 12 and 24 months after surgery.","description":"The functional assessment is performed via clinical scoring using the knee society system score (KSS). KSS value range: [min / max]= 0 - 100, higher values mean better outcome."},{"outcome_type":"secondary","measure":"Functional Assessment via clinical scoring - Visual Analogue Scale","time_frame":"Before surgery and at 1, 3, 6, 12 and 24 months after surgery.","description":"The functional assessment is performed via clinical scoring using the Visual Analogue Scale (VAS). VAS is based on a 10-cm long straight line with one end meaning no pain and the other end meaning the worst pain; on this line, patients are asked to mark a point that matches the amount of pain they feel; the quantification of the point location with respect to the two ends is representative of the ammount of pain."},{"outcome_type":"secondary","measure":"The functional assessment ivia x-ray examinations","time_frame":"Before surgery and at 1, 3, 6, 12 and 24 months after surgery.","description":"The functional assessment is performed via x-ray examinations by reporting knee joint alligments in degrees.."}]}
{"nct_id":"NCT04911374","start_date":"2020-09-11","phase":"N/A","enrollment":45,"brief_title":"An Open-Label Clinical Study to Evaluate the Efficacy of a Face Cream and Eye Cream","official_title":"An Open-Label Clinical Study to Evaluate the Efficacy and Tolerability of a Multi-Ingredient Anti-aging Face Moisturizer and Eye Cream Targeting Aging","primary_completion_date":"2020-12-22","study_type":"Interventional","rec_status":"Completed","completion_date":"2021-02-03","last_update":"2021-06-03","description":"This single-center clinical trial is being conducted to assess the efficacy and tolerability of an anti-aging eye cream and face moisturizer when used over the course of 12 weeks twice-daily by women, 35-65 years, with mild to moderate droopy eyelids, moderate crow's feet wrinkles, and moderate global facial photodamage.","other_id":"C20-D134","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Open-label study. 45 female subjects recruited, 35 to 65 years, Fitzpatrick skin type I-VI, with mild to moderate droopy eyelids, moderate crow's feet wrinkles, and moderate global photodamage.","sampling_method":"","gender":"Female","minimum_age":35,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Women between the ages of 35 and 65 years\r\n\r\n          -  Women with Fitzpatrick skin type I-VI\r\n\r\n          -  Subjects must have mild to droopy eyelids, moderate crow's feet wrinkles, and moderate\r\n             photodamage\r\n\r\n          -  Subjects must have no known medical conditions that, in the investigator's opinion,\r\n             may interfere with study participation.\r\n\r\n          -  Subjects must be willing to provide verbal understanding and written informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subjects which had a health condition and/or pre-existent dormant dermatological\r\n             disease on the face\r\n\r\n          -  Subjects that had any invasive or non-invasive skin treatments, or invasive medical\r\n             procedures three months prior to the study\r\n\r\n          -  Subjects that are unwilling to comply with the protocol\r\n\r\n          -  Female subjects who are pregnant, breast feeding, or planning a pregnancy.\r\n\r\n          -  Subjects who have any dermatological disorder, which in the investigator's opinion,\r\n             may interfere with the accurate evaluation of the subject's skin, including rosacea,\r\n             acne, and excessively oily or dry skin.\r\n\r\n          -  Subjects who have demonstrated a previous hypersensitivity reaction to any of the\r\n             ingredients of the study products.\r\n\r\n          -  Subjects use of any medications that are known to potentially cause changes in the\r\n             facial skin as determined by the Investigator.\r\n\r\n          -  Subjects who spend excessive time out in the sun.\r\n      ","sponsor":"Revision Skincare","sponsor_type":"Industry","conditions":"Wrinkle|Photoaging|Fine Lines","interventions":[{"intervention_type":"Other","name":"Other: Gentle Cleansing Lotion, Revision Skincare","description":"Gentle cleansing lotion to be used by study participants"},{"intervention_type":"Other","name":"Other: Aveeno Face Milk SPF 40+","description":"Sunscreen to be applied after application of face moisturizer and eye cream in the morning. Participants were asked to apply the sunscreen if sun exposure was more than 30 minutes per day."}],"outcomes":[{"outcome_type":"secondary","measure":"Decrease in transepidermal water loss at weeks 4, 8, and 12 versus baseline","time_frame":"12 weeks","description":"• Tewameter Measurements at baseline and weeks 4, 8, and 12. A decrease in Tewameter values reflects an improvement in the barrier properties of the skin; an absence of a change in treated skin indicates mildness of the applied treatment."},{"outcome_type":"primary","measure":"Improvement of Clinical Efficacy Parameters at 4, 8, and 12 weeks versus Baseline","time_frame":"12 weeks","description":"The primary efficacy endpoint will be the Investigator Clinical Grading using Modified Griffith's 10-point Scale. A decrease in scores at week 4, week 8 and week 12 in comparison to baseline indicates an improvement for the indicated parameter.\r\nThe efficacy parameters will be assessed globally on each subject's face using a modified Griffiths' 10-point scale according to the following numerical definitions (half-point scores may be used as necessary to more accurately describe the skin condition): 0 = none (best possible condition); 1 to 3 = mild; 4 to 6 = moderate;7 to 9 = severe (worst possible condition). The lower the score equates to the best possible outcome."},{"outcome_type":"primary","measure":"Lack of Significant Increase in Objective Tolerability Parameters at week 4, 8, 12 compared to Baseline","time_frame":"12 weeks","description":"The primary tolerability endpoint will be the Investigator Tolerability Assessment of Erythema, Edema and Dryness. A decrease in scores or lack of significant increase at week 4, week 8 and week 12 in comparison to Baseline indicates tolerability/safety of the test material. Four point scale with a lower score indicating a better outcome.\r\nExample for Erythema: Erythema 0 = None No erythema of the treatment area\r\n= Mild Slight, but definite redness of the treatment area\r\n= Moderate Definite redness of the treatment area\r\n= Severe Marked redness of the treatment area"},{"outcome_type":"secondary","measure":"Lack of Significant Increase in Subjective Tolerability Parameters at week 4, 8, 12 compared to Baseline","time_frame":"12 weeks","description":"The secondary tolerability endpoint will be the Subject Tolerability Assessment of Burning, Itching and Stinging. A decrease in scores or lack of significant increase at week 4, week 8 and week 12 in comparison to Baseline indicates tolerability/safety of the test material. Four point scale with a lower score indicating a better outcome.\r\nExample Burning. 0 = None No burning of the treatment area\r\n= Mild Slight burning sensation of the treatment area; not really bothersome\r\n= Moderate Definite warm, burning of the treatment area that is somewhat bothersome.\r\n= Severe Hot burning sensation of the treatment area that causes definite discomfort and may interrupt daily activities and/or sleep"},{"outcome_type":"secondary","measure":"Stable skin pH during 12 week study","time_frame":"12 weeks","description":"•pH Measurements at baseline and weeks 4, 8, and 12. A stable pH measurement reflects that the test product does not affect the overall cutaneous pH value."},{"outcome_type":"secondary","measure":"Improvement in Epidermal Thickness after 12 weeks versus baseline","time_frame":"12 weeks","description":"•OCT Imaging Procedures at baseline and week 12, with image analysis performed at the end of the study using images from baseline and week 12. An increase in epidermal thickness indicates improvement."},{"outcome_type":"other","measure":"Self-Assessment Questionnaire","time_frame":"12 weeks","description":"The secondary efficacy endpoints will be the Self-Assessment Questionnaire and the Subject Treatment Satisfaction and Ease of Use Questionnaire. A decrease or increase in response values at week 4, week 8 and week 12 indicates an improvement compared to baseline response values. Subjects are asked to rate based on a scoring system of the following: from 5 (completely agree) to 1 (completely disagree). The best outcome is to Completely Agree with the statement/ question being asked."}]}
{"nct_id":"NCT04549818","start_date":"2020-09-10","phase":"N/A","enrollment":44,"brief_title":"Analgesic Efficacy of Sacral Neuromodulation for Pelvic Cancer Pain: A Preliminary Report","official_title":"Does Sacral Neuromodulation Relieve Chronic Pelvic Cancer Pain, Compared With Medical Treatment?","primary_completion_date":"2021-09-10","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2021-12-10","last_update":"2020-09-16","description":"in this trial, we will test the analgesic efficacy of sacral neuromodulation for patients with pelvic cancer, complaining of chronic pelvic pain in comparison to medical treatment.","other_id":"SECI2020","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age, 18-70\r\n\r\n          -  Pain localized to the pelvic and perineal region\r\n\r\n          -  The pain is due to pelvic cancer or chronic pelvic pain after pelvic surgery for\r\n             cancer\r\n\r\n          -  The intensity of pain assessed by VAS (visual analogue pain scale) > 7\r\n\r\n          -  Importantly, the included participants should gain > 50% reduction of their pain in\r\n             response to sacral roots block, S2,3 and 4 with bupivacaine 0.5%, 2 ml for each root\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Coagulopathy\r\n\r\n          -  Infection at site of maneuver\r\n\r\n          -  Abnormal Psychological behavior that interfere with integrity of obtained data\r\n      ","sponsor":"Assiut University","sponsor_type":"Other","conditions":"Chronic Pain","interventions":[{"intervention_type":"Device","name":"Device: sacral neuromodulation","description":"Sacral neuromodulation group, N=22 will be treated with Stimulation of the sacral nerve roots by placement of a lead and generator, typically using an implanted InterStim device that provides constant electrical stimulation to the S 2, 3 and 4 nerve roots, for 2-week trial stimulation"}],"outcomes":[{"outcome_type":"primary","measure":"The change of intensity of pain","time_frame":"The outcome will be measured at day 15 postoperatively.","description":"The intensity of pain measured by VAS pain score (visual analogue pain scale) where 0= no pain and 10=the maximum tolerated pain"}]}
{"nct_id":"NCT04028817","start_date":"2020-09-10","phase":"N/A","enrollment":40,"brief_title":"Sublingual Photobiomodulation in Parkinson's Disease","official_title":"Evaluation of the Concentrations of Inflammatory, Protein and Oxidative Biomarkers of Parkinson's Disease After Photobiomodulation From Sublingual Laser Application - Clinical, Randomized and Blind Test","primary_completion_date":"2021-08-10","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2021-12-30","last_update":"2020-06-12","description":"This study evaluates the use of photobiomodulation in the treatment of patients with Parkinson's disease. Half of participants will receive treatment with low level laser therapy and exercises in combination, while the other half will receive a placebo laser combined with exercises.","other_id":"sublingual photobiomodulation","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  patients with Parkinson's disease diagnosed with the criteria of the UK Parkinsons'\r\n             Disease Society Brain Bank Clinical Diagnostic Criteria\r\n\r\n          -  In the stages I to III of the disease according to Hoehn & Yahr's Parkinson's disease\r\n             staging scale - modified;\r\n\r\n          -  Individuals of both sexes,\r\n\r\n          -  with more than 50 years\r\n\r\n          -  who sign the informed consent form\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  patients who present some adverse event during the development of the study,\r\n\r\n          -  Who have another associated neurodegenerative disease,\r\n\r\n          -  Have blood dyscrasia, HIV, heart failure, hepatic or renal insufficiency, infections,\r\n             neoplasias, respiratory disorders, hypophysis and hypothalamus problems.\r\n\r\n          -  Who fail to understand or perform procedures correctly because of physical and mental\r\n             limitations.\r\n      ","sponsor":"University of Nove de Julho","sponsor_type":"Other","conditions":"Parkinson Disease","interventions":[{"intervention_type":"Device","name":"Device: photobiomodulation","description":"the intervention will occur twice a week, 18 sessions will be performed, during the sessions will be applied sublingual laser in a single point, with wavelength of 808 nm, diameter of 0.4 cm, with irradiance of 0.8 w / cm2, for 360 s, the laser applied will be of continuous wave with energy of 36J."},{"intervention_type":"Device","name":"Device: placebo photobiomodulation","description":"the intervention will occur twice a week, 18 sessions will be performed, during the sessions will be applied a placebo sublingual laser for 360 s."}],"outcomes":[{"outcome_type":"primary","measure":"10-meter walk test","time_frame":"1 day","description":"This evaluation will be carried out from the application of the tem meter walk test. The test will be performed in a straight hall, with a line 14 meters long. The first 2 meters marked, will be provided so that the patient reaches the usual walking speed, and the last 2 meters will be provided for the patient to decelerate and stop. At the start of the test, patients will receive walking guidance at a comfortable pace."}]}
{"nct_id":"NCT04688905","start_date":"2020-09-09","enrollment":35,"brief_title":"Diagnosing Heart Failure With Preserved Ejection Fraction in Patients With Unexplained Dyspnea (Diagnose-HFpEF)","official_title":"Diagnosestellung Der Herzinsuffizienz Mit Erhaltener Ejektionsfraktion Bei Patienten Mit Unklarer Belastungsdyspnoe - Validierung Gegen Den Invasiven Goldstandard (Diagnose-HFpEF)","primary_completion_date":"2022-09-30","study_type":"Observational","rec_status":"Recruiting","completion_date":"2023-09-30","last_update":"2020-12-30","description":"Invasive diagnosis of heart failure with preserved ejection fraction (HFpEF) in patients with unexplained dyspnea NYHA II-III compared to other diagnostic tools","other_id":"283/20","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":90,"population":"Patients with unexplained dyspnea NYHA II-III","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  dyspnea NYHA II-III\r\n\r\n          -  age 18-90 years\r\n\r\n          -  left ventricular ejection fraction  50%\r\n\r\n          -  ability to give informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  unstable cardiac disease with acute decompensation\r\n\r\n          -  documented former LVEF  40%\r\n\r\n          -  heart valve disease with medium or high grade insufficiency or stenosis\r\n\r\n          -  coronary heart disease with hemodynamically relevant coronary stenosis\r\n\r\n          -  specific cardiomyopathia\r\n\r\n          -  acute or chronic cardiac inflammation (myocarditis, pericarditis)\r\n\r\n          -  former heart transplantation\r\n\r\n          -  relevant pulmonary disease (e.g. COPD) assumably causing the dyspnea\r\n\r\n          -  FEV1/VC < 70%\r\n\r\n          -  hemoglobin < 5 mmol/l\r\n\r\n          -  pregnant or nursing women\r\n\r\n          -  contraindication for one of the diagnostic tests\r\n      ","sponsor":"University of Leipzig","sponsor_type":"Other","conditions":"Dyspnea","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Invasive hemodynamics of left ventricle via conductance catheter at rest, with exercise and with temporary vena cava occlusion","description":"Invasive hemodynamics of left ventricle will be done by the conductance method. Left ventricular stiffness constant will be obtained by temporary vena cava occlusion. Right heart catherization will be done by pulmonary artery catherization and cardiac output will be estimated by thermodilution and Ficks method."}],"outcomes":[{"outcome_type":"primary","measure":"HFpEF-positive patients","time_frame":"Within one day","description":"Percentage of patients with invasively diagnosed heart failure with preserved ejection fraction"},{"outcome_type":"secondary","measure":"H2FPEF score","time_frame":"Within two days","description":"Difference in H2FPEF score in patients with approved and excluded HFpEF (BMI > 30 kg/m²: 2 points, 2 or more antihypertensive medicines: 1 point, atrial fibrillation: 3 points, pulmonary hypertension: 1 point, age > 60 years: 1 point, E/E' > 9: 1 point. Sum: 0-9 points with rising probability of HFpEF with increasing score)"},{"outcome_type":"secondary","measure":"HFA-PEFF score","time_frame":"Within two days","description":"Difference in HFA-PEFF score in patients with approved and excluded HFpEF (0-2 points regarding functional, morpholigical and biomarker parameters. Sum: 0-6 points; 0-1 points:exclusion of HFpEF, 2-5 points: further diagnostic (stress test or invasive) required, 5-6 points: HFpEF diagnosed."},{"outcome_type":"secondary","measure":"Difference in DPVQ (echocardiographic)","time_frame":"Within two days","description":"Diastolic pressure-volume quotient (DPVQ) (at rest and under exertion) in patients with approved and excluded HFpEF"},{"outcome_type":"secondary","measure":"Difference in E/E' (echocardiographic)","time_frame":"Within two days","description":"E/E' (at rest and under exertion) in patients with approved and excluded HFpEF"},{"outcome_type":"secondary","measure":"Difference in GLS (echocardiographic)","time_frame":"Within two days","description":"Global longitudinal strain (at rest and under exertion) in patients with approved and excluded HFpEF"},{"outcome_type":"secondary","measure":"Difference in MRI parameters","time_frame":"Within two days","description":"Fibrosis (using late gadolinium enhancement and T1-Mapping) in patients with approved and excluded HFpEF"},{"outcome_type":"secondary","measure":"Difference in pulmonary artery pressure (right heart catheter)","time_frame":"Within two days","description":"Pulmonary artery pressure at rest and under exertion in patients with approved and excluded HFpEF"},{"outcome_type":"secondary","measure":"Difference in wedge pressure (right heart catheter)","time_frame":"Within two days","description":"Wedge pressure at rest and under exertion in patients with approved and excluded HFpEF"},{"outcome_type":"secondary","measure":"Difference in DPVQ (echocardiographic) after one year","time_frame":"1 year","description":"Diastolic pressure-volume quotient (DPVQ) at rest in patients with approved and excluded HFpEF after one year"},{"outcome_type":"secondary","measure":"Difference in E/E' (echocardiographic) after one year","time_frame":"1 year","description":"E/E' at rest in patients with approved and excluded HFpEF after one year"},{"outcome_type":"secondary","measure":"Difference in GLS (echocardiographic) after one year","time_frame":"1 year","description":"Global longitudinal strain at rest in patients with approved and excluded HFpEF after one year"}]}
{"nct_id":"NCT04043052","start_date":"2020-09-09","phase":"N/A","enrollment":452,"brief_title":"Mobile Technologies and Post-stroke Depression","official_title":"MObile Technologies In the preVention of POSt-stroke DEPression","primary_completion_date":"2023-09-09","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-09-09","last_update":"2021-06-16","description":"The recent development of acute phase treatments has dramatically improved stroke functional outcome but post-stroke neuropsychiatric disorders, notably post-stroke depression, continue to contribute to the heavy burden of stroke. While these conditions affect about 25% of stroke patients at 3 months, they are under-reported spontaneously by patients and are under-evaluated and treated by clinicians. Other than stroke severity and psychiatric history, risk factors for post-stroke depression remain a matter of debate, thus preventing identification of high-risk patients. Moreover, to date, neither pharmacological nor nonpharmacological treatments have demonstrated a significant benefit in the prevention of this disorder, thereby also impeding the development of early treatment strategies. Yet,the early management of post-stroke depression is critical given its negative influence on long-term functional outcomes, medication adherence, efficient use of rehabilitation services and the risk of stroke recurrence or vascular events. There is a pressing need to develop new tools allowing for the early detection of post-stroke neuropsychiatric complications for each individual patient. The rapid expansion of ambulatory monitoring techniques, such as Ecological Momentary Assessment (EMA), allows daily evaluations of mood symptoms in real time and in the natural contexts of daily life. The investigators have previously validated the feasibility and validity of EMA to assess daily life emotional symptoms after stroke, demonstrating its utility to investigate their evolution during the 3 months following stroke and to identify early predictors of post-stroke depression such as stress reactivity and social support, suggesting that EMA could be used in the early personalized care management of these neuropsychiatric complications. Recently, preliminary data have also emphasized the potential of EMA interventions to improve the outcome of psychiatric disorders.","other_id":"CHUBX 2017/49","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age  18 years.\r\n\r\n          -  Male or Female.\r\n\r\n          -  Recent ( 15 days) clinically-symptomatic ischemic or hemorrhagic stroke documented\r\n             through brain imaging (CT or MRI) or a Transient Ischemic Attack with an ABCD2 score \r\n             4.\r\n\r\n          -  Patient discharged to home after hospitalization in the stroke unit.\r\n\r\n          -  No severe neurological handicap: modified Rankin scale  3 at inclusion.\r\n\r\n          -  No severe cognitive impairment or dementia: MoCA  16 at inclusion.\r\n\r\n          -  Written informed consent by the patient.\r\n\r\n          -  Covered by French Social Insurance\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Transient Non Cerebrovascular Event.\r\n\r\n          -  Subarachnoid hemorrhage.\r\n\r\n          -  Dementia syndrome or other neurologic disorder and/or severe aphasia (NIHSS item 9 \r\n             2) interfering with the completion of evaluations and the utilization of EMA.\r\n\r\n          -  Severe visual impairment interfering with the utilization of EMA.\r\n\r\n          -  Severely impaired physical and/or mental health that, according to the investigator,\r\n             may affect the participant's compliance with the study\r\n\r\n          -  Patients with a severe substance use disorder (DSM-5 criteria)\r\n\r\n          -  Patients under antidepressant and/or anxiolytic and/or neuroleptic and/or mood\r\n             stabilizer treatment during the month preceding inclusion\r\n\r\n          -  Participation in another protocol modifying the patient's follow-up status.\r\n\r\n          -  Pregnancy or breastfeeding\r\n\r\n          -  Inability to read French or to use a smartphone\r\n\r\n          -  Individuals under legal protection or unable to express personnally their consent\r\n\r\n          -  Individuals living in an area without 3G/4G internet coverage\r\n      ","sponsor":"University Hospital, Bordeaux","sponsor_type":"Other","conditions":"Stroke|Depression","interventions":[{"intervention_type":"Biological","name":"Biological: Biological assessment","description":"Biological assessment : White and red blood cells count ; platelets count ; Haemoglobin ; CRPus ; Glycaemia ; Plasmatic HbA1c ; Plasmatic LDLc ; HDLc and triglyceride ; Creatinin clearance, Transaminases."},{"intervention_type":"Other","name":"Other: Psychological evaluation","description":"Psychological evaluation including: MINI (current diagnosis) ; HDRS ; MDQ ; GAD-7 ; PC-PTSD-5 ; Quality of Sleep (item 6 of the Pittsburgh Sleep Quality Index) ; CES-D ; BAI ; RRS-short form ; IES-R ; mYFAS2.0;"},{"intervention_type":"Other","name":"Other: Functional evaluation","description":"Functional evaluation including : EQ5-D ; MFI ; LUNS ; SSQ ; Physical activity (IPAQ)"},{"intervention_type":"Other","name":"Other: Ecological Momentary Assessment","description":"During 3 months after inclusion, a 3 to 5 minutes daily interview will administer questions concerning mood symptoms, activities, stress experience, substance use, social relationships and medication intake, activities, social interaction, environmental conditions, experience of depressed mood, anhedonia, changes in weight, appetite, sleep, fatigue, feelings of worthlessness or inappropriate guilt, concentration or decision-making difficulty"}],"outcomes":[{"outcome_type":"secondary","measure":"International Physical Activity Questionnaire (7 items IPAQ)","time_frame":"3 months","description":"The International Physical Activity Questionnaire (7 items IPAQ) assesses physical activity undertaken across a comprehensive set of domains including: a. leisure time physical activity, b. domestic and gardening activities, c. work related physical activity, d. transport-related physical activity. The IPAQ short form asks about three specific types of activity undertaken in these four domains : walking, moderate-intensity activities and vigorous-intensity activities. Computation of the total score for the short form requires summation of the duration (in minutes) and frequency (days) of walking, moderate-intensity and vigorous-intensity activities."},{"outcome_type":"primary","measure":"Hamilton Depression Rating Scale score (HDRS)","time_frame":"Day 0","description":"Semi-structured interview questionnaire designed to be used by a health care professional to investigate depressive symptomatology. 17 items are used to provide a score."},{"outcome_type":"primary","measure":"Hamilton Depression Rating Scale score (HDRS)","time_frame":"3 months","description":"Semi-structured interview questionnaire designed to be used by a health care professional to investigate depressive symptomatology. 17 items are used to provide a score."},{"outcome_type":"primary","measure":"Hamilton Depression Rating Scale score (HDRS)","time_frame":"6 months","description":"Semi-structured interview questionnaire designed to be used by a health care professional to investigate depressive symptomatology. 17 items are used to provide a score."},{"outcome_type":"secondary","measure":"Mini International Neuropsychiatric Interview (MINI)","time_frame":"Day 0"},{"outcome_type":"secondary","measure":"Mini International Neuropsychiatric Interview (MINI)","time_frame":"3 months"},{"outcome_type":"secondary","measure":"Mini International Neuropsychiatric Interview (MINI)","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Mood Disorder Questionnaire (MDQ)","time_frame":"3 months","description":"13 questions on mood symptoms and 2 additional questions on the co-occurrence and psychosocial impact of these symptoms. This questionnaire assesses the probability of an existing bipolar disorder. A positive screen include : a) answering 'Yes' to at least 7 of 13 questions, and b) reporting that several of these symptoms have been experienced during the same period of time, and c) reporting that psychosocial impairment has been caused by these symptoms."},{"outcome_type":"secondary","measure":"Mood Disorder Questionnaire (MDQ)","time_frame":"6 months","description":"13 questions on mood symptoms and 2 additional questions on the co-occurrence and psychosocial impact of these symptoms. This questionnaire assesses the probability of an existing bipolar disorder. A positive screen include : a) answering 'Yes' to at least 7 of 13 questions, and b) reporting that several of these symptoms have been experienced during the same period of time, and c) reporting that psychosocial impairment has been caused by these symptoms."},{"outcome_type":"secondary","measure":"Generalized Anxiety Disorder-7 scale (GAD-7)","time_frame":"3 months","description":"7 items that assess GAD symptoms experienced over the past two weeks. Patients are asked the frequency of these symptoms using a 4-point scale, ranging from 0 (Not at all) to 3 (Nearly every day). A cutoff score of greater than 10 is commonly used to identify cases of GAD."},{"outcome_type":"secondary","measure":"Generalized Anxiety Disorder-7 scale (GAD-7)","time_frame":"6 months","description":"7 items that assess GAD symptoms experienced over the past two weeks. Patients are asked the frequency of these symptoms using a 4-point scale, ranging from 0 (Not at all) to 3 (Nearly every day). A cutoff score of greater than 10 is commonly used to identify cases of GAD."},{"outcome_type":"secondary","measure":"Primary Care PTSD Screen for DSM-5 (PC-PTSD-5)","time_frame":"3 months","description":"5-item screen designed to identify individuals with probable PTSD. It begins with an item designed to assess whether the respondent has had any exposure to traumatic events. If a respondent denies exposure, the scale is completed with a score of 0. If the respondent indicates a trauma history, he/she has additional Yes/No questions about how the traumatic event has affected him/her over the past month. If the total score is 3 or more, the screen indicates probable PTSD."},{"outcome_type":"secondary","measure":"Primary Care PTSD Screen for DSM-5 (PC-PTSD-5)","time_frame":"6 months","description":"5-item screen designed to identify individuals with probable PTSD. It begins with an item designed to assess whether the respondent has had any exposure to traumatic events. If a respondent denies exposure, the scale is completed with a score of 0. If the respondent indicates a trauma history, he/she has additional Yes/No questions about how the traumatic event has affected him/her over the past month. If the total score is 3 or more, the screen indicates probable PTSD."},{"outcome_type":"secondary","measure":"Center of Epidemiological Studies-Depression Scale (CES-D)","time_frame":"3 months","description":"20-item. It measures symptoms of depression in nine different groups as defined by the DSM-5: Sadness (Dysphoria, 3 items), Loss of Interest (Anhedonia, 2 items), Appetite (2 items), Sleep (3 items), Thinking (Concentration, 2 items), Guilt or Worthlessness (2 items), Fatigue (2 items), Agitation (2 items), Suicidal ideation (2 items)."},{"outcome_type":"secondary","measure":"Center of Epidemiological Studies-Depression Scale (CES-D)","time_frame":"6 months","description":"20-item. It measures symptoms of depression in nine different groups as defined by the DSM-5: Sadness (Dysphoria, 3 items), Loss of Interest (Anhedonia, 2 items), Appetite (2 items), Sleep (3 items), Thinking (Concentration, 2 items), Guilt or Worthlessness (2 items), Fatigue (2 items), Agitation (2 items), Suicidal ideation (2 items)."},{"outcome_type":"secondary","measure":"Beck Anxiety Inventory (BAI)","time_frame":"3 months","description":"The Beck Anxiety Inventory (BAI) assesses the severity of patient anxiety during the past week. Though anxiety can be thought of as having several components, including cognitive, somatic, affective, and behavioral components included only two components in the BAI's original version: cognitive and somatic symptoms, with the cognitive subscale providing a measure of fearful thoughts and impaired cognitive functioning whereas the somatic subscale measures the symptoms of physiological arousal. Care was taken during scale construction to eliminate items that would be confounded with depression items. Patients respond to the frequence of 21 symptoms using a scale from 0 (Never) to 3 (Frequently, Almost every day)."},{"outcome_type":"secondary","measure":"Beck Anxiety Inventory (BAI)","time_frame":"6 months","description":"The Beck Anxiety Inventory (BAI) assesses the severity of patient anxiety during the past week. Though anxiety can be thought of as having several components, including cognitive, somatic, affective, and behavioral components included only two components in the BAI's original version: cognitive and somatic symptoms, with the cognitive subscale providing a measure of fearful thoughts and impaired cognitive functioning whereas the somatic subscale measures the symptoms of physiological arousal. Care was taken during scale construction to eliminate items that would be confounded with depression items. Patients respond to the frequence of 21 symptoms using a scale from 0 (Never) to 3 (Frequently, Almost every day)."},{"outcome_type":"secondary","measure":"Ruminative Response Scale-short form (RRS-short form)","time_frame":"3 months","description":"Ruminative Response Scale-short form (RRS-short form) is one of the most widely used self-reported measures of rumination, comprising 9 items and describing the factors of brooding (5 items) and reflection (5 items). For each item, patients indicate the frequency of each event on a 4-point scale ranging from 1 (\"almost never\") to 4 (\"almost always\")."},{"outcome_type":"secondary","measure":"Ruminative Response Scale-short form (RRS-short form)","time_frame":"6 months","description":"Ruminative Response Scale-short form (RRS-short form) is one of the most widely used self-reported measures of rumination, comprising 9 items and describing the factors of brooding (5 items) and reflection (5 items). For each item, patients indicate the frequency of each event on a 4-point scale ranging from 1 (\"almost never\") to 4 (\"almost always\")."},{"outcome_type":"secondary","measure":"Multidimensional Fatigue Inventory (MFI)","time_frame":"3 months","description":"The MFI contains 20 items classified into four dimensions: general fatigue, mental fatigue, reduced activities and motivation. The statements are rated on a 5-point Likert scale (from \"Yes, that is true\" to \"No, that is not true\") representing the patient's current feeling. Low MFI scores reflect a higher degree of fatigue."},{"outcome_type":"secondary","measure":"Multidimensional Fatigue Inventory (MFI)","time_frame":"6 months","description":"The MFI contains 20 items classified into four dimensions: general fatigue, mental fatigue, reduced activities and motivation. The statements are rated on a 5-point Likert scale (from \"Yes, that is true\" to \"No, that is not true\") representing the patient's current feeling. Low MFI scores reflect a higher degree of fatigue."},{"outcome_type":"secondary","measure":"EuroQoL 5-Dimensions Questionnaire (EQ-5D)","time_frame":"3 months","description":"The EuroQoL 5-Dimensions Questionnaire (EQ-5D) is a standardized instrument for use as a measure of health outcome in stroke and was designed for self-completion by respondents. The 5 items of the questionnaire provide a simple descriptive profile and a single index value for health status. The EQ-Index has shown reasonable validity and acceptable responsiveness for detecting the health-related quality of life in stroke patients."},{"outcome_type":"secondary","measure":"EuroQoL 5-Dimensions Questionnaire (EQ-5D)","time_frame":"6 months","description":"The EuroQoL 5-Dimensions Questionnaire (EQ-5D) is a standardized instrument for use as a measure of health outcome in stroke and was designed for self-completion by respondents. The 5 items of the questionnaire provide a simple descriptive profile and a single index value for health status. The EQ-Index has shown reasonable validity and acceptable responsiveness for detecting the health-related quality of life in stroke patients."},{"outcome_type":"secondary","measure":"Long-term Unmet Needs after Stroke (LUNS)","time_frame":"3 months","description":"The Long-term Unmet Needs after Stroke (LUNS) includes 22 items that have each been worded to ask whether the respondent has a need and whether the need is met, and the potential complexity of \"double-barrelled\" questions was managed by providing Yes or No response modalities, with instructions to tick 'No' if there is no need or if the need has been met. Participants are also asked to indicate what level of help (from care givers/friends) they have received in completing the questionnaires, if any."},{"outcome_type":"secondary","measure":"Long-term Unmet Needs after Stroke (LUNS)","time_frame":"6 months","description":"The Long-term Unmet Needs after Stroke (LUNS) includes 22 items that have each been worded to ask whether the respondent has a need and whether the need is met, and the potential complexity of \"double-barrelled\" questions was managed by providing Yes or No response modalities, with instructions to tick 'No' if there is no need or if the need has been met. Participants are also asked to indicate what level of help (from care givers/friends) they have received in completing the questionnaires, if any."},{"outcome_type":"secondary","measure":"Short version of Sarason's Social Support Questionnaire (6 items SSQ)","time_frame":"3 months","description":"Used to measure two dimensions of social support : satisfaction and availability perceptions of social support and satisfaction with that social support. Each item is a question that solicits a two-part answer: Part 1 asks participants to list all the people that fit the description of the question, and Part 2 asks participants to indicate how satisfied they are in general with these people using a 6-point Licket scale (from 1. Very unsatisfied to 6. Extremely satisfied)."},{"outcome_type":"secondary","measure":"Short version of Sarason's Social Support Questionnaire (6 items SSQ)","time_frame":"6 months","description":"Used to measure two dimensions of social support : satisfaction and availability perceptions of social support and satisfaction with that social support. Each item is a question that solicits a two-part answer: Part 1 asks participants to list all the people that fit the description of the question, and Part 2 asks participants to indicate how satisfied they are in general with these people using a 6-point Licket scale (from 1. Very unsatisfied to 6. Extremely satisfied)."},{"outcome_type":"secondary","measure":"International Physical Activity Questionnaire (7 items IPAQ)","time_frame":"Day 0","description":"The International Physical Activity Questionnaire (7 items IPAQ) assesses physical activity undertaken across a comprehensive set of domains including: a. leisure time physical activity, b. domestic and gardening activities, c. work related physical activity, d. transport-related physical activity. The IPAQ short form asks about three specific types of activity undertaken in these four domains : walking, moderate-intensity activities and vigorous-intensity activities. Computation of the total score for the short form requires summation of the duration (in minutes) and frequency (days) of walking, moderate-intensity and vigorous-intensity activities."},{"outcome_type":"secondary","measure":"International Physical Activity Questionnaire (7 items IPAQ)","time_frame":"6 months","description":"The International Physical Activity Questionnaire (7 items IPAQ) assesses physical activity undertaken across a comprehensive set of domains including: a. leisure time physical activity, b. domestic and gardening activities, c. work related physical activity, d. transport-related physical activity. The IPAQ short form asks about three specific types of activity undertaken in these four domains : walking, moderate-intensity activities and vigorous-intensity activities. Computation of the total score for the short form requires summation of the duration (in minutes) and frequency (days) of walking, moderate-intensity and vigorous-intensity activities."},{"outcome_type":"secondary","measure":"Percentage of stroke risk","time_frame":"Day 0","description":"The Riskometer application will be used to measure the stroke risk based on recorded parameters. The Stroke Riskometer app assesses the possibility of suffering a stroke using a number of health and lifestyle factors including age, sex, ethnic origin, blood pressure, atrial fibrillation, left ventricular hypertrophy, anti-hypertension, tobacco, cardiovascular history, weight / height ratio, cholesterol level, diabetes, alcohol, stress, cognitive decline, family and personal history of stroke and TIA, history of head trauma and myocardial infarction"},{"outcome_type":"secondary","measure":"Percentage of stroke risk","time_frame":"3 months","description":"The Riskometer application will be used to measure the stroke risk based on recorded parameters. The Stroke Riskometer app assesses the possibility of suffering a stroke using a number of health and lifestyle factors including age, sex, ethnic origin, blood pressure, atrial fibrillation, left ventricular hypertrophy, anti-hypertension, tobacco, cardiovascular history, weight / height ratio, cholesterol level, diabetes, alcohol, stress, cognitive decline, family and personal history of stroke and TIA, history of head trauma and myocardial infarction"},{"outcome_type":"secondary","measure":"Percentage of stroke risk","time_frame":"6 months","description":"The Riskometer application will be used to measure the stroke risk based on recorded parameters. The Stroke Riskometer app assesses the possibility of suffering a stroke using a number of health and lifestyle factors including age, sex, ethnic origin, blood pressure, atrial fibrillation, left ventricular hypertrophy, anti-hypertension, tobacco, cardiovascular history, weight / height ratio, cholesterol level, diabetes, alcohol, stress, cognitive decline, family and personal history of stroke and TIA, history of head trauma and myocardial infarction"},{"outcome_type":"secondary","measure":"Recurrent stroke","time_frame":"3 months","description":"Recurrent stroke or TIA post-stroke defined by standard clinico-radiological criteria"},{"outcome_type":"secondary","measure":"Recurrent stroke","time_frame":"6 months","description":"Recurrent stroke or TIA post-stroke defined by standard clinico-radiological criteria"},{"outcome_type":"secondary","measure":"Cardiovascular events post-stroke","time_frame":"3 months","description":"Cardiovascular events post-stroke defined by standard clinical criteria"},{"outcome_type":"secondary","measure":"Cardiovascular events post-stroke","time_frame":"6 months","description":"Cardiovascular events post-stroke defined by standard clinical criteria"},{"outcome_type":"secondary","measure":"Intensity of post-stroke pain","time_frame":"Day 0","description":"Intensity of post-stroke pain using a visual analog scale"},{"outcome_type":"secondary","measure":"Intensity of post-stroke pain","time_frame":"3 months","description":"Intensity of post-stroke pain using a visual analog scale"},{"outcome_type":"secondary","measure":"Intensity of post-stroke pain","time_frame":"6 months","description":"Intensity of post-stroke pain using a visual analog scale"},{"outcome_type":"secondary","measure":"Pittsburgh Sleep Quality Index","time_frame":"Visit 1 ; 3 months ; 6 months","description":"Quality of sleep using the item 6 of the Pittsburgh Sleep Quality Index"},{"outcome_type":"secondary","measure":"Blood pressure","time_frame":"Visit 1 ; 3 months ; 6 months","description":"Blood pressure"},{"outcome_type":"secondary","measure":"HbA1c measure","time_frame":"3 months ; 6 months","description":"Glycaemic control using the HbA1c measure"},{"outcome_type":"secondary","measure":"LDLc plasmatic measure","time_frame":"3 months ; 6 months","description":"Lipidic control using the LDLc plasmatic measure"},{"outcome_type":"secondary","measure":"CRPus plasmatic measure","time_frame":"3 months ; 6 months","description":"Systemic inflammation will be evaluated using CRPus plasmatic measure"},{"outcome_type":"secondary","measure":"Smoking Index (HSI)","time_frame":"3 months ; 6 months","description":"Tobacco use will be evaluated using the Heaviness of Smoking Index (HSI)"}]}
{"nct_id":"NCT04875728","start_date":"2020-09-08","phase":"Phase 1","enrollment":20,"brief_title":"The Impact of an Antibiotic (Cefazolin) Before Surgery on the Microbiome in Patients With Stage I-II Melanoma","official_title":"Evaluating the Impact of Perioperative Antibiotic Prophylaxis on the Microbiome in Patients With Cutaneous Malignancy","primary_completion_date":"2021-05-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-05-31","last_update":"2021-05-17","description":"This phase I trial investigates the impact of cefazolin before surgery on the microbiome in patients with stage I-II melanoma. Antibiotics, such as cefazolin, given at the time of surgery may cause a significant change in the microbes (like bacteria and viruses) found in the stomach and intestines. This trial may help researchers learn if any changes in microbes affect the body's ability to respond to surgery and cancer.","other_id":"2020-0265","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adult subjects with early stage melanoma (stage I-II)\r\n\r\n          -  Patients must be undergoing wide local excision +/- sentinel lymph node biopsy\r\n\r\n          -  Patients must be capable of giving written informed consent, which includes compliance\r\n             with the requirements and restrictions listed in the consent form\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Use of antibiotics within the three months prior to surgery\r\n\r\n          -  Allergy, sensitivity or anaphylaxis to beta-lactam or cephalosporin antibiotics\r\n\r\n          -  Presence of an infection at the time of surgery\r\n\r\n          -  Increased risk of infection due to a co-existing medical condition as determined by\r\n             the surgical team or principal investigator (PI)\r\n\r\n          -  Subjects with a condition requiring systemic treatment with either corticosteroids (>\r\n             10 mg daily prednisone equivalents) or other immunosuppressive medications within 14\r\n             days of study drug administration\r\n\r\n          -  American Society of Anesthesiologists (ASA) grade > IV\r\n\r\n          -  Refusal to participate in the study\r\n\r\n          -  Patients who are pregnant will not be included in this study\r\n      ","sponsor":"M.D. Anderson Cancer Center","sponsor_type":"Other","conditions":"Clinical Stage I Cutaneous Melanoma AJCC v8|Clinical Stage IA Cutaneous Melanoma AJCC v8|Clinical Stage IB Cutaneous Melanoma AJCC v8|Clinical Stage II Cutaneous Melanoma AJCC v8|Clinical Stage IIA Cutaneous Melanoma AJCC v8|Clinical Stage IIB Cutaneous Melanoma AJCC v8|Clinical Stage IIC Cutaneous Melanoma AJCC v8|Pathologic Stage I Cutaneous Melanoma AJCC v8|Pathologic Stage IA Cutaneous Melanoma AJCC v8|Pathologic Stage IB Cutaneous Melanoma AJCC v8|Pathologic Stage II Cutaneous Melanoma AJCC v8|Pathologic Stage IIA Cutaneous Melanoma AJCC v8|Pathologic Stage IIB Cutaneous Melanoma AJCC v8|Pathologic Stage IIC Cutaneous Melanoma AJCC v8","interventions":[{"intervention_type":"Drug","name":"Drug: Cefazolin","description":"Given IV"},{"intervention_type":"Procedure","name":"Procedure: Resection","description":"Undergo standard of care surgical resection"}],"outcomes":[{"outcome_type":"primary","measure":"Change in microbiome alpha diversity","time_frame":"Baseline up to 2 weeks post-surgery","description":"The diversity, structure, and composition of the fecal microbiome will be determined by 16S(v4) rRNA gene sequencing. 16S profiles will be used to compute alpha diversity, beta diversity, and the relative abundance of fecal bacteria. The composition of fecal bacteria in adult humans is mainly dominated by members of the Firmicutes and Proteobacteria phyla while members of Proteobacteria, Actinobacteria, Fusobacteria, and Verrucomicrobia are observed in lower abundance. To calculate richness (alpha-diversity), we will count each operational taxonomic unit (OTU) or amplicon sequence variant (ASV) identified. Richness count is expected to range between 10-500 per sample."},{"outcome_type":"secondary","measure":"Change in relative abundance of microbes","time_frame":"Baseline, at 2 weeks post-surgery, and 3 months post-surgery"},{"outcome_type":"secondary","measure":"Change in microbiome diversity","time_frame":"Baseline up to 3 months post-surgery","description":"The diversity, structure, and composition of the fecal microbiome will be determined by 16S(v4) rRNA gene sequencing. 16S profiles will be used to compute alpha diversity, beta diversity, and the relative abundance of fecal bacteria. The composition of fecal bacteria in adult humans is mainly dominated by members of the Firmicutes and Proteobacteria phyla while members of Proteobacteria, Actinobacteria, Fusobacteria, and Verrucomicrobia are observed in lower abundance. To calculate richness (alpha-diversity), we will count each operational taxonomic unit (OTU) or amplicon sequence variant (ASV) identified. Richness count is expected to range between 10-500 per sample."},{"outcome_type":"secondary","measure":"Wound (surgical site) infection rate","time_frame":"Up to 3 months post-surgery"},{"outcome_type":"secondary","measure":"Profiling of systemic immune function by analysis of composition of circulating immune cell populations and cytokines","time_frame":"Up to 3 months post-surgery","description":"By analysis of composition of circulating immune cell populations and cytokines."}]}
{"nct_id":"NCT04454671","start_date":"2020-09-05","phase":"N/A","enrollment":62,"brief_title":"Ultrasound-guided Percutaneous Neuromodulation Versus Dry Needling in Shoulder Pain Treatment","official_title":"Efficacy of Ultrasound-guided Percutaneous Neuromodulation Versus Ultrasound-guided Dry Needling of the Suprascapular Nerve in Shoulder Pain","primary_completion_date":"2021-09-15","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-11-10","last_update":"2021-08-31","description":"Background: nonspecific shoulder pain is very common and the symptoms can persist for 6 to 12 months in half of patients. Ultrasound-guided Percutaneous Neuromodulation (US-guided PNM) is an intervention based in an electrical stimulation of a peripheral nerve through a needle located close to the target nerve by the use of an ultrasound guidance. Objectives: the primary aim is to determine changes in strength after US-guided PNM or Ultrasound-guided Dry Needling (US-guided DN) intervention in the Suprascapular Nerve (SN) as well as its effectiveness in changes of muscle function, pain and disability. Methods: randomised clinical trial (ratio 1:1), single-blind (examiners), parallel, with assessment of third parties. 62 adult participants with unilateral mechanical chronic nonspecific shoulder pain with at least 3-month evolution and shoulder muscle weakness will randomised to one of two procedures: US-guided PNM or US-guided DN. It will be assessed muscle strength, muscle function, pain and disability before, just after, a week and a month after the intervention.","other_id":"CEIM/HU/2019/26)","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Chronic mechanical unilateral shoulder pain of non-specific origin of at least 3\r\n             months of evolution\r\n\r\n          -  Weakness in the abduction force and / or external rotation of the shoulder.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Previous shoulder surgery.\r\n\r\n          -  Previous history of shoulder dislocation\r\n\r\n          -  Whiplash.\r\n\r\n          -  Cervical radiculopathy.\r\n\r\n          -  Total rupture of the rotator cuff.\r\n\r\n          -  Adhesive capsulitis.\r\n\r\n          -  Fibromyalgia diagnosis.\r\n\r\n          -  Diabetes.\r\n\r\n          -  Needle phobia or some contraindication for dry needling (anticoagulants or psychiatric\r\n             disorders).\r\n\r\n          -  Bilateral shoulder pain.\r\n\r\n          -  Pregnancy or having received a dry puncture in the shoulder region in the last 6\r\n             months\r\n      ","sponsor":"University of Alcala","sponsor_type":"Other","conditions":"Shoulder Pain","interventions":[{"intervention_type":"Other","name":"Other: Ultrasound-guided percutaneous neuromodulation (NMPE)","description":"It is a technique based on electrical stimulation of a peripheral nerve through an ultrasound-guided needle or a muscle at a motor site. The stimulation is performed with low or medium frequency currents in which a sensory and / or motor response is sought by stimulating the peripheral nerve"},{"intervention_type":"Other","name":"Other: Ultrasound-guided dry needling","description":"Dry needling technique under ultrasound imaging in order to ensure accurate placement of the needle for optimum results."}],"outcomes":[{"outcome_type":"primary","measure":"Muscle Force","time_frame":"Change from Baseline force at 1 month","description":"Force will be measured by a manual dynamometer (microFET®2, Hoggan Scientific LLC). Measurements will be taken in Newtons (N). It will be evaluated in the movements of external rotation and abduction of both shoulders.\r\nManual dynamometry has proven to be a tool with excellent intra-examiner reliability to assess isometric force in external rotation of the shoulder, with an intraclass correlation coefficient (ICC) of 0.96 (0.93-0.98). The minimum value is 0 and de Maximum values is 55"},{"outcome_type":"secondary","measure":"Shoulder Pain","time_frame":"Change from Baseline pain at 1 month.","description":"Pain intensity will be measured using the Visual Analog Scale (VAS) for pain. The VAS is a 100-mm line, oriented horizontally, with one end representing \"no pain\" and ten the other end representing \"worst pain.\" Subjects will be asked to rate their current pain with a mark on the scale."},{"outcome_type":"secondary","measure":"Disability","time_frame":"Change from Baseline disability at 1 month.","description":"Disability will be measured by Shoulder Pain and Disability Index (SPADI).The Spanish version of SPADI has high test-retest reliability (ICC 0.89-0.93).The clinically important minimum difference varies between 8 and 13.2. The minimum value is 0 and de maximum value is 100"},{"outcome_type":"secondary","measure":"Muscle function","time_frame":"Change from Baseline muscle function at 1 month.","description":"Muscle function will be measured by an ultrasound scanner (VINNO® E35; VINNO ULTRASOUND S.L.U. ©, Barcelona, Spain) with a linear transducer with a frequency range of 6-16MHz (X6-16L, 5cm footprint) will be used. The unit of measurement used will be millimeters. Muscle thickness at rest and contraction will be measured. On the other hand, the percentage of change in thickness will be measured using the equation (Shrinkage thickness - Rest thickness) * 100 / Rest thickness."}]}
{"nct_id":"NCT04237194","start_date":"2020-09-01","enrollment":20,"brief_title":"A New Diagnostic Method to Assess Paclitaxel-Induced Peripheral Neuropathy","official_title":"A New Diagnostic Method to Assess Paclitaxel-Induced Peripheral Neuropathy","primary_completion_date":"2021-06-30","study_type":"Observational","rec_status":"Recruiting","completion_date":"2024-06-30","last_update":"2020-09-17","description":"To assess the impact of Paclitaxel treatment on the nerve excitability of the small and large nerve fibers","other_id":"N-20190071","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"Female","minimum_age":18,"population":"Breast cancer patients receiving adjuvant chemotherapy, consisting of 3 cycles of\r\n        Epirubicin and Cyclophosphamide (EC), followed by 3 cycles of Paclitaxel (9 Paclitaxel\r\n        infusions).","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. > 18 years\r\n\r\n          2. Histopathologically verified breast cancer\r\n\r\n          3. Performance Status according to WHO/ECOG (PS) 0-2\r\n\r\n          4. Candidate for adjuvant standard treatment with EC and Paclitaxel\r\n\r\n          5. Not previously treated with chemotherapeutic agents\r\n\r\n          6. Neurological examination without pathological findings\r\n\r\n          7. Willingness to voluntarily sign an informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Previously neoadjuvant treatment with chemotherapy\r\n\r\n          2. Receives prophylactic bone marrow stimulants\r\n\r\n          3. HIV\r\n\r\n          4. Diabetes mellitus\r\n\r\n          5. Opioid requirement\r\n\r\n          6. Symptomatic neurosensory disorders\r\n\r\n          7. Neurological diseases, such as sclerosis and epilepsy\r\n\r\n          8. Alcohol abuse\r\n\r\n          9. \"Palmar-plantar erythrodysesthesia syndrome\" / ulceration of hands or feet\r\n\r\n         10. Cannot understand written or oral information in Danish\r\n\r\n         11. Inability to cooperate\r\n      ","sponsor":"Carsten Dahl Mrch","sponsor_type":"Other","conditions":"Chemotherapy-induced Peripheral Neuropathy","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Change of Nerve fiber excitability","time_frame":"The difference between baseline and the 6 months follow-up","description":"The chronaxie and the rheobase to rectangular stimuli, the accommodation to triangular stimuli, and the electrotonus to subthreshold hyperpolarizing pre-pulses for large and small sensory nerves from the excitability measure."},{"outcome_type":"secondary","measure":"Change of Quantitative sensory test","time_frame":"The difference between baseline and the 6 months follow-up","description":"The Quantitative sensory test is a reduced version of the German protokol and contains warmth and cold detection thresholds, heat and cold pain thresholds, vibration threshold and perceived intensity to mechanical stimuli."},{"outcome_type":"secondary","measure":"Changed of CTCAE","time_frame":"The difference between baseline and the 6 months follow-up","description":"Common Terminology Criteria for Adverse events scale is a scale from 0 to 5, where 5 is worse."},{"outcome_type":"secondary","measure":"Change of CIPN20.","time_frame":"The difference between baseline and the 6 months follow-up","description":"Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy Twenty-Item scale is a 20-item self-report questionnaire. Items are scored 1-4 with 1 representing \"not at all\" and 4 \"very much.\" Scores are then linearly converted to a 0-100 scale where 100 is worse."}]}
{"nct_id":"NCT04200768","start_date":"2020-09-01","phase":"N/A","enrollment":150,"brief_title":"FATLAS: Comprehensive Multi-level Characterization of Systemic and Mammary Adiposity in Breast Cancer Patients.","official_title":"FATLAS: Comprehensive Multi-level Characterization of Systemic and Mammary Adiposity in Breast Cancer Patients.","primary_completion_date":"2024-10-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2024-10-31","last_update":"2020-11-04","description":"FATLAS is a prospective, interventional, non Investigational Medicinal Product (IMP) study aiming to characterize the micro- and macroenvironment of breast cancer according to patient adiposity in different histological and molecular subtypes. The macroscopic profiling of the patient's adiposity will be based on Body Mass Index (BMI), bioimpedance analysis and waist-to-hip ratio. Blood samples will be taken for lipidomic analyses and for hormonal and immuno assays. Microscopic profiling of adiposity and inflammation will be done on fresh frozen (FF) and Formalin-Fixed Paraffin-Embedded (FFPE) samples from the tumour resection specimen and will consist of histological characterization, immuno assays, multiplex immunohistochemistry, DNA sequencing and single nuclei RNA sequencing both in the tumour and in adjacent normal mammary tissue.","other_id":"S63330","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Inclusion of 30 lean (BMI 18.5 - 24.9 kg/m), 30 overweight (BMI 25 - 29.9 kg/m), and 30\r\n        obese (BMI  30 kg/m) patients with histological confirmation of Invasive Ductal Carcinoma\r\n        (IDC) on core diagnostic biopsy; 5 lean, 5 overweight and 5 obese Inflammatory Breast\r\n        Cancer (IBC) patients; 15 lean, 15 overweight and 15 obese patients with histological\r\n        confirmation of Invasive Lobular Carcinoma (ILC) on core diagnostic biopsy and 20 male\r\n        subjects with any type of breast cancer that meet following criteria:\r\n\r\n          -  be willing and able to provide written informed consent for this study;\r\n\r\n          -  be willing to provide plasma/blood and tissue samples;\r\n\r\n          -  be willing to have clinical measures of adiposity taken;\r\n\r\n          -  have stage I, II or III disease (so non-metastatic) with any clinical lymph node\r\n             status;\r\n\r\n          -  be scheduled for surgical resection of the tumour in UZ Leuven.\r\n\r\n          -  have a tumour size of  1.5 cm in order to have sufficient tumour material for the\r\n             biomarker analysis. Exceptions will be made for IBC patients, as in some cases no\r\n             residual tumour will be found after neoadjuvant treatment;\r\n\r\n          -  be treatment nave, i.e. not having received systemic breast cancer treatment prior to\r\n             surgery. An exception is made for the IBC patients, as they will often have received\r\n             first line neoadjuvant chemotherapy before surgery. IBC patients that do not undergo\r\n             surgery after neoadjuvant treatment (e.g. because of inoperability of the patient)\r\n             will not be included;\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  pregnancy at time of diagnosis;\r\n\r\n          -  personal history of breast cancer (relapse/second primary);\r\n\r\n          -  mixed invasive tumour type on core biopsy or special type of breast carcinoma beside\r\n             pure ILC;\r\n\r\n          -  history of an additional malignancy that is progressing or that has required active\r\n             treatment in the 5 years prior to breast cancer diagnosis. Exceptions include basal\r\n             cell carcinoma of the skin or squamous cell carcinoma of the skin that have undergone\r\n             potentially curative therapy or in situ cervical cancer;\r\n\r\n          -  presence of an immune dysregulatory disease or condition which requires active immune\r\n             modulatory treatment of any kind, or has required treatment in the past two years.\r\n             Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid\r\n             replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a\r\n             form of systemic treatment;\r\n\r\n          -  history or current evidence of any condition, therapy, or laboratory abnormality that\r\n             might confound the results of the trial in the opinion of the treating investigator.\r\n      ","sponsor":"Universitaire Ziekenhuizen Leuven","sponsor_type":"Other","conditions":"Breast Neoplasms","interventions":[{"intervention_type":"Other","name":"Other: Prospective data and sample collection","description":"Performance of measurements of adiposity, extra collection of blood samples"}],"outcomes":[{"outcome_type":"primary","measure":"BMI","time_frame":"Before surgery","description":"Calculated: body mass (kg) divided by height squared (m²)"},{"outcome_type":"primary","measure":"Lipid levels in plasma","time_frame":"Before surgery","description":"Lipidomic analysis"},{"outcome_type":"primary","measure":"Up- or downregulation of pathways on single cell level","time_frame":"At surgery","description":"Single nucleus RNA sequencing using 10X Genomics Platform after dissociation of tissue into single nuclei"},{"outcome_type":"primary","measure":"T cell repertoire","time_frame":"At surgery","description":"Number of T-cells per population using immunohistochemical phenotypic markers of cell type and of exhaustion."},{"outcome_type":"primary","measure":"Physical activity level","time_frame":"Before surgery","description":"Time of activity of different intensities and time of sedentarity, evaluated using the Global Physical Activity Questionnaire (GPAQ) of the World Health Organisation (WHO) (scale: minutes per day, range [0 - 1440]). The higher the score for activity the better, the lower the score for sedentarity the better."},{"outcome_type":"primary","measure":"Sleep behaviour score","time_frame":"Before surgery","description":"Pittsburgh Sleep Quality Index (PSQI) score (range: [0 - 21]). Higher scores indicate worse sleep quality."},{"outcome_type":"primary","measure":"Dietary Quality Index","time_frame":"Before surgery","description":"Nutritional score (natural number, range [0 - 100]) calculated using the in-house Food Frequency Questionnaire. A score of > 70 indicates healthy dietary behaviour."},{"outcome_type":"primary","measure":"Dietary Food Intake","time_frame":"Before surgery","description":"Food intake in kcal per day calculated using the in-house Food Frequency Questionnaire."},{"outcome_type":"primary","measure":"Fat percentage","time_frame":"Before surgery","description":"Calculated from multiple frequency bio-impedance measurements (in %, range [0 - 100])."},{"outcome_type":"primary","measure":"Waist-to-hip ratio","time_frame":"Before surgery","description":"Waist circumference (cm) divided by hip circumference (cm)"},{"outcome_type":"primary","measure":"Handgrip strength","time_frame":"Before surgery","description":"In kilograms (kg), measured by handheld dynamometer."}]}
{"nct_id":"NCT04515056","start_date":"2020-09-01","phase":"N/A","enrollment":20,"brief_title":"Characterization of New Human Models of Non-histaminergic Itch","official_title":"Characterization of New Human Models of Non-histaminergic Itch and Their Interaction With the TRPM8 Receptor","primary_completion_date":"2021-06-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2021-06-01","last_update":"2021-07-09","description":"In this experiment the investigators would like to test a new new human itch model based on papain, and to characterize the sensory quality and temporary aspects of papain skin prick test (SPT) in comparison to the inactivated-cowhage delivery system.","other_id":"N-20200005","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Basic Science","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy men and women\r\n\r\n          -  18-60 years\r\n\r\n          -  Speak and understand English\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnancy or lactation\r\n\r\n          -  Drug addiction defined as any use of cannabis, opioids or other addictive drugs\r\n\r\n          -  Previous or current history of neurological, dermatological, immunological\r\n             musculoskeletal, cardiac disorder or mental illnesses that may affect the results\r\n             (e.g. neuropathy, muscular pain in the upper extremities, etc.).\r\n\r\n          -  Lack of ability to cooperate\r\n\r\n          -  Current use of medications that may affect the trial such as antihistamines,\r\n             antipsychotics and pain killers, as well as systemic or topical steroids.\r\n\r\n          -  Skin diseases\r\n\r\n          -  Moles, scars or tattoos in the area to be treated or tested.\r\n\r\n          -  Hypersensitivity to papaya and mango fruit, cashew nuts, rubber latex\r\n\r\n          -  Consumption of alcohol or painkillers 24 hours before the study days and between these\r\n\r\n          -  Acute or chronic pain\r\n\r\n          -  Participation in other trials within 1 week of study entry (4 weeks in the case of\r\n             pharmaceutical trials)\r\n      ","sponsor":"Aalborg University","sponsor_type":"Other","conditions":"Papain|Itch|Skin Prick Test (SPT)","interventions":[{"intervention_type":"Drug","name":"Drug: Papain 10 g","description":"The area will be exposed to 10 g of papain."},{"intervention_type":"Drug","name":"Drug: Papain 50 g","description":"The area will be exposed to 50 g of papain."},{"intervention_type":"Drug","name":"Drug: Papain 100 g","description":"The area will be exposed to 100 g of papain."},{"intervention_type":"Other","name":"Other: Vehicle","description":"The area will be exposed to vehicle"},{"intervention_type":"Drug","name":"Drug: Papain 1 SPT","description":"Papain will be applied by 1 SPT prick thought the skin"},{"intervention_type":"Drug","name":"Drug: Papain 5 SPT","description":"Papain will be applied by 5 SPT pricks thought the skin"},{"intervention_type":"Drug","name":"Drug: Papain 25 SPT","description":"Papain will be applied by 25 SPT pricks thought the skin"},{"intervention_type":"Other","name":"Other: Cowhage","description":"The last area will be exposed to cowage spicules (made chemically inert by autoclaving) soaked in 5 mg/ml papain solution."}],"outcomes":[{"outcome_type":"primary","measure":"Superficial blood perfusion","time_frame":"15 minutes","description":"Superficial blood perfusion is measured by a Speckle contrast imager (FLPI, Moor Instruments, England)."},{"outcome_type":"primary","measure":"Measuring itch intensity by computerized Visual Analog Scale Scoring","time_frame":"15 minutes","description":"The subjects will rate the sensation of itch on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates \"no itch\" and 100 indicates \"worst itch imaginable\" and similarly for sensations of stinging/pricking and burning, both of which are frequently associated with the sensation of itch."},{"outcome_type":"primary","measure":"Measuring pain intensity by computerized Visual Analog Scale Scoring","time_frame":"15 minutes","description":"The subjects will rate the sensation of pain on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates \"no pain\" and 100 indicates \"worst pain imaginable\"."},{"outcome_type":"primary","measure":"Measuring Alloknesis","time_frame":"15 minutes","description":"Alloknesis is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 milliNewton of force). This stimulator is applied 0.5 cm outside the area of itch provocation."},{"outcome_type":"secondary","measure":"Measurement of Cold Detection Thresholds (CDT)","time_frame":"15 minutes","description":"The tests for thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device. A thermode stimulator of 3x3 cm will be placed on the treated/placebo areas and kept in place by means of Velcro tape. During the first 8 seconds, the temperature decreases 1°C per second from a starting temperature of 32°C until the subject perceives a temperature change (cold sensation) and presses a button that will terminate the measurement and return the temperature to baseline at a rate of 5°C /s. A cut-off temperature of 0°C will be used."},{"outcome_type":"secondary","measure":"Measurement of Cold Pain Thresholds (CPT)","time_frame":"15 minutes","description":"The tests for thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device. A thermode stimulator of 3x3 cm will be placed on the treated/placebo areas and kept in place by means of Velcro tape. During the first 8 seconds, the temperature decreases 1°C per second from a starting temperature of 32°C until the subject perceives a temperature change (cold sensation) and presses a button that will terminate the measurement and return the temperature to baseline at a rate of 5°C /s. A cut-off temperature of 0°C will be used."},{"outcome_type":"secondary","measure":"Measurement of Warm Detection Thresholds (WDT)","time_frame":"15 minutes","description":"The tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device. A thermode stimulator of 3x3 cm will be placed on the treated/placebo areas and kept in place by means of Velcro tape. During the first 8 seconds, the temperature raises 1°C per second from a starting temperature of 32°C until the subject detects a painful sensation and presses a button that will terminate the measurement and return the temperature to baseline at a rate of 5°C /s. A cut-off temperature of 52°C will be used."},{"outcome_type":"secondary","measure":"Measurement of Heat Pain Thresholds (HPT)","time_frame":"15 minutes","description":"The tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device. A thermode stimulator of 3x3 cm will be placed on the treated/placebo areas and kept in place by means of Velcro tape. During the first 8 seconds, the temperature raises 1°C per second from a starting temperature of 32°C until the subject detects a painful sensation and presses a button that will terminate the measurement and return the temperature to baseline at a rate of 5°C /s. A cut-off temperature of 52°C will be used."},{"outcome_type":"secondary","measure":"Measurement of Pain to Supra-threshold Heat Stimuli","time_frame":"15 minutes","description":"The tests will be conducted by using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device. A thermode stimulator of 3x3 cm will be placed on the treated/placebo areas and kept in place by means of Velcro tape. The subjects will have to rate the pain to two suprathreshold heat pain stimuli (starting and ending at 32°C with an increase and decrease of 5°C and 3 s plateau at 50°C)."},{"outcome_type":"secondary","measure":"Measurement of Mechanical Pain Thresholds (MPT)","time_frame":"15 minutes","description":"This test is conducted using a pin-prick set (Aalborg University, Aalborg)."},{"outcome_type":"secondary","measure":"Measurement of Mechanical Pain Sensitivity (MPS)","time_frame":"15 minutes","description":"This test is conducted using a pin-prick set (Aalborg University, Aalborg)."},{"outcome_type":"secondary","measure":"Touch Pleasantness (TP)","time_frame":"15 minutes","description":"Pleasant touch sensation measured using a standardized sensory brush (SENSELab Brush-05, Somedic AB, Hörby, Sweden) exerting a force of 200 to 400 mN."}]}
{"nct_id":"NCT04504084","start_date":"2020-09-01","phase":"N/A","enrollment":100,"brief_title":"Influence of Patient Decision-Making Aids for Patients With Unilateral Ureteral Stone: A Randomized-Controlled Trial","official_title":"Influence of Patient Decision-Making Aids for Patients With Unilateral Ureteral Stone: A Randomized-Controlled Trial","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2021-12-31","last_update":"2020-08-07","description":"Ureteral stone is a common disease with high prevalence and recurrence rate in Taiwan. Taiwan is located in subtropical zone, where urolithiasis is commonly seen. A national survey in Taiwan determined that 9.6% of the population suffered stones throughout their lifetime. Symptoms of ureteral stone include renal colic, hematuria, and urinary tract infection. Without proper treatment, ureteral stone could lead to renal function impairment such as acute kidney injury (AKI) or chronic kidney disease (CKD). There are several treatment options for ureteral stone, such as ureteroscopic lithotripsy (URSL), flexible urteroscopic lithotripsy (F-URSL), percutaneous nephrolithotomy (PCNL), extracorporeal shock wave lithotripsy (ESWL), and Medical expulsive therapy (MET). However, there are only few minutes from diagnosis of ureteral stone to possible treatment options explanation. It's difficult for patients to well understand all the details of possible treatments under such circumstances. Therefore, we design a patient decision aid (PDA) for unilateral ureteral stone to help patients understand all the treatment options. The PDA is standardized, written in plain language and patient-centered, with pictures attached.","other_id":"N202003100","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"Double","intervention_model_description":"Parallel Assignment","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Ages between 18 and 75\r\n\r\n          -  Ureteral stone diagnosed with KUB, IVP or CT\r\n\r\n          -  Stone size between 0 to 2 cm\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Stone passage spontaneously\r\n\r\n          -  Patients who do not speak Mandarian\r\n\r\n          -  Patients with dementia\r\n\r\n          -  Nationality not Republic of China\r\n\r\n          -  Patients with bilateral ureteral stone\r\n\r\n          -  Patients with staghorn stone\r\n\r\n          -  Patients with bladder stone\r\n\r\n          -  Patients with severe infection\r\n\r\n          -  Pregnant women\r\n\r\n          -  Others patients could not communicate with\r\n      ","sponsor":"Taipei Medical University Shuang Ho Hospital","sponsor_type":"Other","conditions":"Patient Decision Aids|Ureteral Stone|Shared Decision Making","interventions":[{"intervention_type":"Other","name":"Other: Decision aid","description":"Patient Decision Aid is a tool that helps patient with ureteral stone become involved in decision making on choosing treatment for ureteral stone. Patient Decision Aid provides information about the options and outcomes, and by clarifying personal values."}],"outcomes":[{"outcome_type":"primary","measure":"Decision conflicts","time_frame":"For patients choose URSL or F-URSL, one day before the operation. For patients choose ESWL, half an hour before the treatment.","description":"Total score of decisional conflict scale"},{"outcome_type":"secondary","measure":"SURE test","time_frame":"For patients choose URSL or F-URSL, one day before the operation. For patients choose ESWL, half an hour before the treatment.","description":"Total score of SURE test"}]}
{"nct_id":"NCT02645942","start_date":"2020-08-31","phase":"N/A","enrollment":0,"brief_title":"L-carnitine for Reducing Cardio-metabolic Risk in Patients With Obstructive Sleep Apnea","official_title":"L-carnitine for Reducing Cardio-metabolic Risk in Patients With Obstructive Sleep Apnea - Double Blind Randomized Clinical Trial","primary_completion_date":"2020-12-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2021-02-28","last_update":"2020-05-06","description":"The investigators designed this intervention to investigate the potential role of L-C in lipid and carbohydrates metabolism (primary outcome) with precision noninvasively measurement of: central blood pressure, pulse wave velocity and peripheral arterial stiffness (secondary outcome) in OSA patients.","other_id":"962/15","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  diagnosed OSA classified according to the apnea hypopnea index (AHI) as a mild\r\n             (5.0-14.9), moderate (15.0-29.9), and severe (30.0 events per hour),\r\n\r\n          -  treatment with Continuous Positive Airway Pressure (CPAP) for at least 6 months before\r\n             study screening,\r\n\r\n          -  disturbed lipid metabolism (according to the National Health and Nutrition Examination\r\n             Survey: LDL-C>100 mg/dl, or TG>150 mg/dl) or use of hypolipidemic drugs,\r\n\r\n          -  disturbed glucose metabolism (Diabetes mellitus or impaired glucose tolerance or\r\n             impaired fasting glucose) according to American Diabetes Federation or use of\r\n             hypoglycaemic drugs,\r\n\r\n          -  willingness to participate in the study,\r\n\r\n          -  age over 18,\r\n\r\n          -  continued habitual diet during the study period,\r\n\r\n          -  performance status  80 according to Karnofsky score\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  newly diagnosed OSA and individuals treated with CPAP,\r\n\r\n          -  other than OSA lung dysfunctions,\r\n\r\n          -  do not use of hypoglycaemic and hypolipidemic drugs,\r\n\r\n          -  modification of hypolipidemic or hypoglycaemic treatment during the study period,\r\n\r\n          -  pregnancy or lactation,\r\n\r\n          -  cancer (excluding curatively treated with no evidence of diseases for 5 years),\r\n\r\n          -  severe liver and kidney diseases (Aspartate aminotransferase (ASPAT) and alanine\r\n             aminotransferase (ALAT) >3  the upper limit of normal (ULN), Bilirubin >1.5  ULN,\r\n             Creatinine >1.5  ULN),\r\n\r\n          -  known sensitivity to any component of the product,\r\n\r\n          -  diagnosed CVD (myocardial infarct, stroke, angina pectoris).\r\n\r\n          -  an active drug or alcohol abuse,\r\n\r\n          -  legal incompetence,\r\n\r\n          -  limited legal incompetence,\r\n\r\n          -  any uncontrolled medical condition that may put studied patients at high risk during\r\n             study period\r\n      ","sponsor":"Poznan University of Medical Sciences","sponsor_type":"Other","conditions":"Obstructive Sleep Apnea","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: L-carnitine","description":"L-carnitine 1400 mg daily for 8 weeks"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Placebo","description":"Placebo daily for 8 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Changes in Total cholesterol, LDL cholesterol, HDL cholesterol and Triglycerides concentration","time_frame":"6 months"},{"outcome_type":"primary","measure":"Changes in fasting glucose concentration","time_frame":"6 months"},{"outcome_type":"primary","measure":"Changes in insulin concentration","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Changes in central blood pressure","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Changes in pulse wave velocity","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Changes in peripheral arterial stiffness","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Number of participants with treatment-related adverse events as assessed by CTCAE v4.0","time_frame":"6 months"}]}
{"nct_id":"NCT04360070","start_date":"2020-08-31","phase":"N/A","enrollment":24,"brief_title":"The Application of Ketamine for Sedation in Patients With Cardiac Arrest","official_title":"The Application of Ketamine for Sedation in Patients With Cardiac Arrest: Feasibility, Safety, and Potential Impact on Neurological Outcomes","primary_completion_date":"2020-12-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2021-06-30","last_update":"2020-07-07","description":"Recent evidence suggests ketamine may attenuate harmful cellular cascades taking place after brain injury that result in permanent damage. The investigators are interested in researching the application of this in the setting of cardiac arrest. Following cardiac arrest, the brain is deprived oxygen for a period of time, leading to the imitation of these harmful cellular processes. The investigators hypothesize that patients who receive ketamine as part of their standard sedation procedures during cardiac arrest treatment have better neurological functioning compared to those who do not.","other_id":"001","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":19,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  All out-of-hospital cardiac arrests (OHCA) with a \"shockable rhythm\" (ventricular\r\n             fibrillation, pulseless ventricular tachycardia) that present to the Royal Columbian\r\n             Hospital. The patient may be either in active cardiac arrest with shockable rhythm or\r\n             may have achieved Return of Spontaneous Circulation (ROSC).\r\n\r\n          -  Over 19 years of age\r\n\r\n          -  Patients requiring sedation based on the assessment of the resuscitating physician.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any other type of cardiac arrest\r\n\r\n          -  Any history of previous, pre-existing neurological deficit\r\n\r\n          -  Started on Extracorporeal Membrane Oxygenation (ECMO)\r\n\r\n          -  Duration of cardiac arrest without ROSC is greater than 30 consecutive minutes\r\n\r\n          -  Known contraindication or hypersensitivity to ketamine\r\n\r\n          -  Awake patient or no standard sedation or no intubation required\r\n\r\n          -  Inability to obtain deferred consent\r\n\r\n          -  Currently enrolled in any other research study involving drugs or devices\r\n\r\n          -  Patients who are pregnant\r\n\r\n          -  Patients who are prisoners\r\n\r\n          -  Patients residing in Long Term Care (LTC) facilities\r\n      ","sponsor":"Fraser Health","sponsor_type":"Other","conditions":"Cardiac Arrest, Out-Of-Hospital|Ketamine|Neurologic Manifestations","interventions":[{"intervention_type":"Drug","name":"Drug: Ketamine Hydrochloride","description":"Parenteral General Anesthetic"}],"outcomes":[{"outcome_type":"primary","measure":"Feasibility Data","time_frame":"through study completion, an average of 6 months.","description":"To test the appropriateness of the eligibility criteria by recording enrolment rates of eligible patients, test the randomization assignment procedures by evaluating for any difference in baseline characteristics between groups, and test adequate adherence to protocol by recording time taken to administer intervention during sedation procedures."}]}
{"nct_id":"NCT04513431","start_date":"2020-08-30","phase":"Early Phase 1","enrollment":18,"brief_title":"A Clinical Research of CAR T Cells Targeting CEA Positive Colorectal Cancer (CRC)","official_title":"A Study Evaluating the Safety and Preliminary Efficacy of Anti-CEA CAR-T Cells for the Prevention of Postoperative Recurrence and Metastasis of Stage III Colorectal Cancer or Liver Metastasis of Colorectal Cancer","primary_completion_date":"2021-03-30","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2023-08-30","last_update":"2020-08-14","description":"The main purpose of this research is to verify the safety of CEA targeted chimeric antigen receptor T cells and to determine the proper dosage of CAR T cells infused.","other_id":"RJBY_anti-CEA CAR-T_CRC01","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. CEA positive T4/N2 high-risk stage- colorectal cancer after surgery or patients with\r\n             colorectal cancer liver metastasis after R0 surgery;\r\n\r\n          2. Patients whose serum CEA 11 ng/mL;\r\n\r\n          3. Life expectancy  3 months;\r\n\r\n          4. PS score 0-2, KPS score 60;\r\n\r\n          5. >3 CTC/7.5 mL blood sample;\r\n\r\n          6. Patients who plan to use XELOX chemotherapy after surgery;\r\n\r\n          7. Patients must have adequate organ function , such as NYHA heart function\r\n             classification grade III or higher, no severe anemia, hypoxia; liver function: total\r\n             bilirubin  1.5  ULN (total bilirubin  3  ULN when liver metastasis), ALT2.5ULN,\r\n             AST2.5ULN (ALT or/and AST5ULN when liver metastasis); renal function: blood\r\n             creatinine 1.5  ULN and creatinine clearance 50 mL/min, only when blood creatinine\r\n              Calculate the creatinine clearance rate when 1.5  ULN;\r\n\r\n          8. Sufficient peripheral blood can be obtained through peripheral veins without\r\n             contraindications to apheresis;\r\n\r\n          9. Patients of childbearing age have no birth plans and take effective contraceptive\r\n             measures during the study period and within 1 year after the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients who have a history of severe central nervous system disease;\r\n\r\n          2. Other organ metastases except liver;\r\n\r\n          3. Patients who have non malignant diseases, including autoimmune diseases, primary\r\n             immunodeficiency diseases or obstructive or restrictive respiratory diseases;\r\n\r\n          4. Patients received car-t or other gene modified T cell therapy previously;\r\n\r\n          5. Patients who plan to use other targeted anti-tumor drugs;\r\n\r\n          6. Patients who participated in other clinical studies within 30 days before screening or\r\n             planned to participate in other clinical studies during the study period;\r\n\r\n          7. Patients who have syphilis or HIV / HBV / HCV / HPV / EBV / CMV infection ; HBV-DNA\r\n             copy number  1  10 ^ 5 copies / ml is required for HBV seropositive patients;\r\n\r\n          8. Patients who have uncontrollable systemic infectious diseases;\r\n\r\n          9. Patients who have multiple malignant tumor;\r\n\r\n         10. Patients who received or may need Chinese herbal medicine, systemic glucocorticoid or\r\n             other immunosuppressants within 2 weeks before enrollment;\r\n\r\n         11. Patient who are pregnancy and lactating;\r\n\r\n         12. Patients who have severe gastroduodenal ulcer, ulcerative colitis and other intestinal\r\n             inflammation;\r\n      ","sponsor":"Ruijin Hospital","sponsor_type":"Other","conditions":"Stage III Colorectal Cancer|Colorectal Cancer Liver Metastasis","interventions":[{"intervention_type":"Biological","name":"Biological: Anti-CEA-CAR T","description":"T cells modified with CEA targeted chimeric antigen receptor."}],"outcomes":[{"outcome_type":"secondary","measure":"Efficacy of anti-CEA CAR T cells to confirm the ability of CAR T cells to kill CEA positive cancer cells","time_frame":"6 months","description":"To evaluate the presence of circulating tumor cells with flow cytometry and real time PCR in patient blood."},{"outcome_type":"secondary","measure":"Maximum tolerated dose (MTD) of CEA targeted CAR T cells","time_frame":"4 weeks","description":"To confirm the maximum tolerated dose of CEA targeted CAR T cells."},{"outcome_type":"primary","measure":"Adverse events that related to treatment","time_frame":"4 weeks","description":"Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)"},{"outcome_type":"secondary","measure":"Survival time of Anti-CEA CAR T cells in vivo.","time_frame":"3 months","description":"To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood."}]}
{"nct_id":"NCT04212494","start_date":"2020-08-30","phase":"N/A","enrollment":3838,"brief_title":"Thrombus Aspiration in STEMI Patients With High Thrombus Burden","official_title":"Thrombus Aspiration in Primary Percutaneous Coronary Intervention for STEMI Patients With High Thrombus Burden","primary_completion_date":"2023-08-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2024-02-29","last_update":"2021-03-03","description":"This is a prospective, multicenter, open-label, randomized, controlled, parallel group study, in which ST-segment Elevation Myocardial Infarction (STEMI) patients with high thrombus burden(TIMI thrombus grade 3) are included. Patients are randomized to be treated with or without manual thrombus aspiration(TA) during primary percutaneous coronary intervention(PPCI) by a ratio of 1:1.","other_id":"GDREC2018404H(R2)","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age  18 years;\r\n\r\n          2. STEMI patients undergoing primary PCI within 12 hours after the onset of symptoms;\r\n\r\n          3. High thrombus burden after guidewire passes the lesion (TIMI thrombus grade 3);\r\n\r\n          4. Informed consent must be voluntary;\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Haemodynamic instability or cardiogenic shock;\r\n\r\n          2. After thrombolytic therapy;\r\n\r\n          3. The predicted survival time is less than 6 months due to non-cardiac disease;\r\n\r\n          4. History of coronary artery bypass grafting;\r\n\r\n          5. Participate in other researches within 30 days;\r\n\r\n          6. Preoperative gastrointestinal bleeding or contraindications to dual antiplatelet\r\n             therapy;\r\n\r\n          7. Patients were considered unsuitable by other researchers.\r\n      ","sponsor":"Guangdong Provincial People's Hospital","sponsor_type":"Other","conditions":"ST-segment Elevation Myocardial Infarction (STEMI)","interventions":[{"intervention_type":"Procedure","name":"Procedure: Thrombus aspiration","description":"Percutaneous Coronary Intervention with manual aspiration thrombectomy"},{"intervention_type":"Procedure","name":"Procedure: Thrombus aspiration","description":"Percutaneous Coronary Intervention without manual aspiration thrombectomy"}],"outcomes":[{"outcome_type":"primary","measure":"Major adverse cardiovascular events","time_frame":"up to180 days","description":"The first occurrence of cardiovascular death, recurrent myocardial infarction, stent thrombosis or target vessel revascularization"},{"outcome_type":"secondary","measure":"Stroke","time_frame":"up to 30 days","description":"The symptoms continuing for more than 24 hours or leading to death with no apparent cause other than vascular"},{"outcome_type":"secondary","measure":"Composite adverse cardiocerebrovascular events","time_frame":"up to 1 year","description":"The first occurence of cardiovascular death, recurrent myocardial infarction, stent thrombosis, target vessel revascularization or stroke."}]}
{"nct_id":"NCT04685642","start_date":"2020-08-24","phase":"Phase 4","enrollment":180,"brief_title":"Anti-inflmmation Treatment in Mood Disorder and Deep Learning Prediction Model","official_title":"Anti-inflmmation Treatment in Mood Disorder and Deep Learning Prediction Model","primary_completion_date":"2023-07-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-07-31","last_update":"2020-12-28","description":"This three-year study will enroll 180 patients with mood disorders (90 patients with major depressive disorder and 90 patients with bipolar disorder) and high pro-inflammatory cytokine levels. They will be randomly assigned to three groups of aspirin, statin and control groups for 12 weeks according to the disease group. The first aim of the study is to compare the efficacy of aspirin and statin in mood disorders. The second aim is to establish a gene-immuno-brain imaging treatment prediction model by deep learning technology, using pretreatment cytokines, neurocognitive function, brain structural/functional connectivity, and telomere length as the predictors.","other_id":"109-2314-B-010 -050 -MY3","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age between 20 to 65 years old.\r\n\r\n          2. The baseline pro-inflammatory cytokines level: soluble IL6 receptor\r\n             (sIL-6)>35,000pg/ml, or CRP>1,500ng/ml, or sTNF-R1>1,000pg/ml.\r\n\r\n          3. Maintain psychiatric medication for more than three months.\r\n\r\n          4. Voluntary patients and controls with signed informed consent proved by institutional\r\n             review board (IRB).\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients have used aspirin, statin previously .\r\n\r\n          2. Patients have gastrointestinal disease, history of gastrointestinal bleeding,\r\n             hematology coagulation disease, sever liver and renal disease.\r\n\r\n          3. Patients with schizophrenia, organic brain diseases, mental retardation.\r\n\r\n          4. Patients with symptoms of substance abuse/dependence (except nicotine dependence)\r\n             within 3 months.\r\n\r\n          5. Patients with autoimmune, acute infection and critical medical illnesses .\r\n\r\n          6. Patients who cannot cooperate the study protocol.\r\n      ","sponsor":"Taipei Veterans General Hospital, Taiwan","sponsor_type":"Other","conditions":"Mood Disorder","interventions":[{"intervention_type":"Drug","name":"Drug: Aspirin","description":"Aspirin (100mg/day)"},{"intervention_type":"Drug","name":"Drug: Atorvastatin","description":"Atorvastatin (20mg/day)"}],"outcomes":[{"outcome_type":"primary","measure":"Reduction rate the clinical symptoms after original treatment combined aspirin or atorvastatin.","time_frame":"baseline, week 4, week 8, week 12","description":"Treatment Efficacy"},{"outcome_type":"secondary","measure":"The T1-weight","time_frame":"Once on baseline.","description":"The T1-weight will be taken on a 3T MR scanner (Discovery 750, GE)."},{"outcome_type":"secondary","measure":"The resting fMRI","time_frame":"Once on baseline.","description":"The resting fMRI will be taken on a 3T MR scanner (Discovery 750, GE)."}]}
{"nct_id":"NCT04348058","start_date":"2020-08-20","phase":"N/A","enrollment":6300,"brief_title":"Telephone Services for Participation in Colorectal Cancer Screening","official_title":"Telephone Services for Participation Improvement in Colorectal Cancer Screening: a Randomized Health Services Study","primary_completion_date":"2021-07-30","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2021-08-30","last_update":"2020-04-15","description":"A multicentre randomized health services study within the population-based primary colonoscopy screening program (PCSP) in Poland. Individuals, aged 55-60 years, willl be randomized in a 1:1:1 ratio to arms: (1) Invitation by post, (2) Call Center or (2) Combined invitation methods. The primary outcome measure is rate of participation in screening colonoscopy. The sample size of 6 300 participants will detect 3 to 5 percentage point differences (depending on the arms comparison) in participation rate between groups with 80% power and significance level 0.05, using Ochran-Mantel-Haenszel test.","other_id":"ColoPhone","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Health Services Research","masking_description":"None (Open Label)","intervention_model_description":"prospective","sampling_method":"","gender":"All","minimum_age":55,"maximum_age":64,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  population included to invitation within Polish population based Colorectal cancer\r\n             Screening Program (PCSP)\r\n\r\n               -  55-64 of age\r\n\r\n               -  no history of CRC\r\n\r\n               -  no history of screening colonoscopy within PCSP\r\n\r\n          -  adress of residence near (not further than 40 kilometers) local PCSP centers (selected\r\n             for the study based on population density)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  none\r\n      ","sponsor":"Maria Sklodowska-Curie Institute - Oncology Center","sponsor_type":"Other","conditions":"Participation Rate, Patient","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Telephone recruitment to screening colonoscopy","description":"Utilisation of dedicated call center for recruitment to screening program instead of traditional, paper invitation"},{"intervention_type":"Behavioral","name":"Behavioral: Combined methods recruitment to screening colonoscopy","description":"Utilisation of dedicated call center for recruitment to screening program in participants, who did not respond to traditional, paper invitation"}],"outcomes":[{"outcome_type":"primary","measure":"Participation rate to screening colonoscopy within PCSP per recruitment strategy","time_frame":"26 weeks after intervention","description":"The percentage of study participants who underwent screening colonoscopy relative to all PCSP participants to whom the invitation was sent in a given group during the observation period (intention-to-screen analysis)"},{"outcome_type":"secondary","measure":"Response rate to invitation to screening colonoscopy","time_frame":"26 weeks after intervention","description":"Contact with local PCSP center"}]}
{"nct_id":"NCT04452877","start_date":"2020-08-19","phase":"Phase 2","enrollment":20,"brief_title":"A Study of Dabrafenib in Combination With Trametinib in Chinese Patients With BRAF V600E Mutant Metastatic NSCLC","official_title":"An Open-Label, Single-arm Study to Evaluate the Safety and Efficacy of Dabrafenib in Combination With Trametinib in Chinese Patients With BRAF V600E Mutation-Positive Metastatic Non-Small Cell Lung Cancer","primary_completion_date":"2021-11-01","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2023-06-27","last_update":"2021-05-27","description":"The purpose of this study is to evaluate the safety and efficacy of dabrafenib in combination with trametinib in Chinese patients with BRAF V600E mutation-positive metastatic Non-Small Cell Lung Cancer. The general study design has been discussed and agreed with Chinese Health Authority and is applying a similar design used for global pivotal phase II study (BRF113928).","other_id":"CDRB436ECN01","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically or cytologically confirmed diagnosis of Stage IV NSCLC (according to\r\n             AJCC 8th edition) that is BRAF V600E mutation-positive by local test result from a\r\n             qualified assay (NMPA and/or MOH-approved)\r\n\r\n          -  Previously treated or untreated for metastatic NSCLC:\r\n\r\n               1. Subjects previously treated should have received no more than 3 prior systemic\r\n                  therapies for metastatic disease, including one prior platinum based\r\n                  chemotherapy, and should have documented disease progression on a prior treatment\r\n                  regimen (i.e. RECIST 1.1)\r\n\r\n               2. Subjects who have received prior therapy with checkpoint inhibitor therapy (i.e.\r\n                  anti-PD-1/PD-L1) must have had objective evidence of disease progression (i.e.\r\n                  RECIST v1.1) while on or after this therapy prior to enrollment.\r\n\r\n               3. Subjects with EGFR or ALK mutation who have previously received therapy with EGFR\r\n                  or ALK inhibitor(s) respectively are eligible\r\n\r\n          -  Measurable disease per RECIST v1.1\r\n\r\n          -  Anticipated life expectancy of at least 3 months\r\n\r\n          -  ECOG performance status  2.\r\n\r\n          -  Adequate bone marrow and organ function as defined by the following laboratory values\r\n             without continuous supportive treatment (such as blood transfusion, coagulation\r\n             factors and/or platelet infusion, or red/white blood cell growth factor\r\n             administration) as assessed by local laboratory for eligibility: Hemoglobin  9 g/dL;\r\n             Absolute neutrophil count  1.5  109/L; Platelets  100  109/L; PT/INR and PTT  1.5\r\n             x ULN; Serum creatinine < 1.5 mg/dL; Total bilirubin  1.5  ULN (upper limit of\r\n             normal) except for subjects with Gilbert's syndrome who may only be included if the\r\n             total bilirubin is  3.0  ULN or direct bilirubin  1.5  ULN; AST and ALT  2.5 \r\n             ULN, except for subjects with liver metastasis, who may only be included if AST/ALT \r\n             5.0  ULN Albumin  2.5 g/dL\r\n\r\n          -  Left ventricular ejection fraction (LVEF)  lower limit of institutional normal (LLN)\r\n             as assessed by ECHO or MUGA scan\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subjects with brain or leptomeningeal metastases are excluded if their these\r\n             metastases are: symptomatic or treated but not clinically and radiographically stable\r\n             3 weeks after local therapy or asymptomatic and untreated but >1 cm in the longest\r\n             dimension\r\n\r\n          -  Previous treatment with a BRAF inhibitor or a MEK inhibitor\r\n\r\n          -  All prior anti-cancer treatment-related toxicities must be Grade 2 or less according\r\n             to the Common Terminology Criteria for Adverse Events version 4 (CTCAE version 4.03;\r\n             NCI, 2009) at the time of enrollment\r\n\r\n          -  Prior anti-cancer treatment within the last 2 weeks, and prior treatment with immune\r\n             checkpoint inhibitors within 4 weeks preceding the first dose of the study treatment.\r\n\r\n          -  Current use of a prohibited medication\r\n\r\n          -  Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs\r\n             chemically related to the study treatments, their excipients, and/or dimethyl\r\n             sulfoxide (DMSO).\r\n\r\n          -  Subjects with known history for testing positive for Human Immunodeficiency Virus\r\n             (HIV)\r\n\r\n          -  History of another malignancy <3 years prior to starting study treatment or any\r\n             malignancy with confirmed activating RAS-mutation.\r\n\r\n          -  Cardiac or cardiac repolarization abnormality\r\n\r\n          -  A history or current evidence/risk of retinal vein occlusion (RVO) or serous\r\n             retinopathy\r\n\r\n          -  History or current interstitial lung disease or non-infectious pneumonitis\r\n\r\n          -  Any serious or unstable pre-existing medical conditions (aside from malignancy\r\n             exceptions specified above), psychiatric disorders, or other conditions that, in the\r\n             opinion of the investigator, could interfere with the subject's safety, obtaining\r\n             informed consent, or compliance with study procedures\r\n\r\n          -  Pregnant or nursing (lactating) women.\r\n\r\n          -  Sexually active males (including those that have had a vasectomy) must use a condom\r\n             during intercourse and should not father a child during this period. The amount of\r\n             time a patient must use a condom for 16 weeks post treatment discontinuation\r\n\r\n          -  Subjects with active Hepatitis B infection (HbsAg positive)\r\n\r\n          -  Subjects with positive test for hepatitis C ribonucleic acid (HCV RNA)\r\n\r\n          -  Concurrent participation in other clinical trials using experimental therapies\r\n      ","sponsor":"Novartis Pharmaceuticals","sponsor_type":"Industry","conditions":"Carcinoma, Non-Small-Cell Lung","interventions":[{"intervention_type":"Drug","name":"Drug: Dabrafenib","description":"Dabrafenib will be provided by the sponsor to the investigative site or supplied locally as commercially available. Dabrafenib will be administered orally twice daily (150 mg BID) for Days 1-21 of a 21-day cycle."},{"intervention_type":"Drug","name":"Drug: Trametinib","description":"Trametinib will be provided by the sponsor to the investigative site or supplied locally as commercially available. Trametinib will be administered orally once daily (2 mg QD) for Days 1-21 of a 21-day cycle"}],"outcomes":[{"outcome_type":"primary","measure":"Overall Response Rate (ORR), central independent review assessed by RECIST v1.1","time_frame":"From baseline until disease progression, death, lost to follow-up or withdrawal of consent, whichever occurs first, assessed up to approximately 12 months from treatment initiation","description":"Overall Response Rate is defined as the percentage of subjects with a confirmed complete response (CR) or partial response (PR) by central independent review as per RECIST v1.1 criteria"},{"outcome_type":"secondary","measure":"Overall response rate (ORR), investigator assessed by RECIST v1.1","time_frame":"From baseline until disease progression, death, lost to follow-up or withdrawal of consent, whichever occurs first, assessed up to approximately 12 months from treatment initiation","description":"ORR is defined as the percentage of subjects with a confirmed complete response (CR) or partial response (PR) by investigator assessment as per RECIST 1.1 criteria"},{"outcome_type":"secondary","measure":"Progression Free Survival (PFS), investigator assessed by RECIST v1.1","time_frame":"From baseline until disease progression or death due to any cause, whichever occurs first, assessed up to approximately 12 months from treatment initiation","description":"PFS is defined as the interval between first dose and the earliest date of disease progression or death due to any cause. PFS will be assessed via local review according to RECIST 1.1."},{"outcome_type":"secondary","measure":"Duration of Response (DoR), investigator assessed by RECIST v1.1","time_frame":"From first documented response until first documented progression or death due to any cause, whichever occurs first, assessed up to approximately 12 months from treatment initiation","description":"DoR is defined for the subset of subjects with confirmed CR or PR, as the time from first documented evidence of CR or PR until time of first documented disease progression according to RECIST v1.1 per local review or death due to any cause"},{"outcome_type":"secondary","measure":"Overall Survival (OS)","time_frame":"From baseline until death due to any cause, assessed up to approximately 33 months from treatment initiation","description":"OS is defined as the time from first dose until death due to any cause"},{"outcome_type":"secondary","measure":"Trough concentration of dabrafenib","time_frame":"Pre-dose sample at visits week 3, 6 and 12","description":"Mean trough concentration will be calculated at each timepoint"},{"outcome_type":"secondary","measure":"Trough concentration of dabrafenib metabolites","time_frame":"Pre-dose sample at visits week 3, 6 and 12","description":"Mean trough concentration will be calculated at each timepoint"},{"outcome_type":"secondary","measure":"Trough concentration of trametinib","time_frame":"Pre-dose sample at visits week 3, 6 and 12","description":"Mean trough concentration will be calculated at each timepoint"},{"outcome_type":"secondary","measure":"Mean change from baseline in the European Quality of Life (EuroQol)- 5 Dimensions, 5 Level Questionnaire (EQ-5D-5L) score","time_frame":"From baseline, every 3 weeks until end of treatment (up to approximately 32 months after treatment initiation)","description":"EQ-5D-5L is a standardized measure to assess the overall health-related quality of life in patients."},{"outcome_type":"secondary","measure":"Mean change from baseline in the European Organization for Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ-C30) score","time_frame":"From baseline, every 3 weeks until end of treatment (up to approximately 32 months after treatment initiation)","description":"EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients."},{"outcome_type":"secondary","measure":"Mean Change from Baseline in the European Organization for Research and Treatment of Cancer lung cancer specific module (EORTC QLQ-LC13) score","time_frame":"From baseline, every 3 weeks until end of treatment (up to approximately 32 months after treatment initiation)","description":"EORTC QLQ-LC13 is a 13-item lung cancer specific questionnaire."},{"outcome_type":"secondary","measure":"Number of patients with Adverse Events (AEs) and Serious Adverse Events (SAEs)","time_frame":"From baseline until end of study, assessed up to approximately 33 months from treatment initiation","description":"Safety profile of dobrafenib in combination with trametinib. Incidence of Adverse Events and Serious Adverse events, including abnormal laboratory values or test results."}]}
{"nct_id":"NCT04265040","start_date":"2020-08-18","enrollment":2040,"brief_title":"DZHK TORCH-Plus is a Registry for Patients With Cardiomyopathies and Serves as Source for Cardiovascular Research Studies","official_title":"TranslatiOnal Registry for CardiomyopatHies (TORCH) - Plus as Part of the German Centre for Cardiovascular Research (DZHK)","primary_completion_date":"2027-12-31","study_type":"Observational [Patient Registry]","rec_status":"Recruiting","completion_date":"2027-12-31","last_update":"2020-12-16","description":"The DZHK TranslatiOnal Registry for CardiomyopatHies (DZHK TORCH) represents a unique resource of clinical data and high quality biological samples to enable innovative clinical and molecular studies on cardiomyopathies (CMP). As a multi-center German cardiomyopathy registry, TORCH has been prospectively admitting patients since December 2014. 2,300 patients were recruited as planned. Taken together, patient data showed that the prevalence of these diseases is much higher in men than in women, atrial fibrillation is common in all forms of CMPs as well as rare forms of disease indicate a higher risk and higher morbidity. This DZHK TORCH register is now to be expanded with a second phase (DZHK TORCH-Plus). The second phase DZHK TORCH-Plus consists of 4 main modules: 1. \"Clinical phenotyping, follow-up & biosampling\" 2. \"Genomics\", 3. \"Inflammation\" and 4. \"Biomarker\". The central aims are 1) to significantly increase the number of probands (n = 4340) in order to better address the different types of CMPs, especially patients with rare CMP forms such as LVNC and ARVC or with probably molecularly explainable cardiomyopathies (familial DCM), 2) to prolong the longitudinal with a further follow-up to achieve sufficient events and thereby derive clinical recommendations for risk assessment, 3) to increase the number of probands with state-of-the-art phenotyping, 4) to pinpoint the effect of myocardial inflammation, fibrosis, gender and to determine or predict genotypes based for outcome, 5) to validate novel biomarkers developed in other DZHK studies, and 6) to foster active cooperation with international CMP registries and partners from industry.","other_id":"TORCH-Plus DZHK21","observational_model":"Other","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":80,"population":"Primary care clinic","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Non-ischemic structural cardiomyopathies\r\n\r\n          -  Age  18 or  80 years\r\n\r\n          -  The patient is able to understand the declaration of consent and to sign it dated\r\n\r\n          -  At least one of the following diagnoses depending on the specific TORCH-\r\n\r\n        Plus inclusion / exclusion - SOP:\r\n\r\n        Dilated Cardiomyopathy (DCM)\r\n\r\n          -  family / genetic\r\n\r\n          -  inflammatory / persistent myocarditis\r\n\r\n          -  idiopathic (after exclusion secondary cause)\r\n\r\n          -  left sided systolic dysfunction (EF  45%)\r\n\r\n        Left ventricular hypertrophy\r\n\r\n          -  sarcomere hypertrophic cardiomoypathia (HCM, HOCM)\r\n\r\n          -  amyloid (AL: light chains, TTR: transthyretin, wild type)\r\n\r\n        Left ventricular non-compaction cardiomyopathy (LVNC)\r\n\r\n        Arrhythmogenic right ventricular cardiomyopathy (ARVC / D)\r\n\r\n        Exclusion Criteria:\r\n\r\n        The following exclusion criteria have been defined and must be taken from the TORCH-Plus\r\n        specific inclusion / exclusion - SOP in detail:\r\n\r\n          -  Age: <18 years or> 80 years\r\n\r\n          -  Patient has other (cardiac) previous illnesses:\r\n\r\n               -  uncontrollable arterial hypertension\r\n\r\n               -  primary pulmonary arterial hypertension\r\n\r\n               -  radiation therapy in the chest area\r\n\r\n               -  addiction (drug or alcohol abuse)\r\n\r\n               -  life expectancy <1 year due to non-cardiological pre-existing conditions\r\n\r\n               -  significant heart valve disease\r\n\r\n               -  ischemic diseases and severe congenital heart diseases (including VSD, Fallot\r\n                  tetralogy, Ebstein anomaly)\r\n\r\n               -  chemotoxic cardiomyopathy\r\n\r\n               -  condition after myocarditis\r\n\r\n               -  combination of several traditional risk factors (e.g. hypertension and diabetes\r\n                  mellitus)\r\n\r\n               -  advanced chronic non-cardiac disease (e.g. chronic hepatitis or HIV)\r\n\r\n               -  Tachymyopathy\r\n      ","sponsor":"University Hospital Heidelberg","sponsor_type":"Other","conditions":"Non-ischemic Cardiomyopathy|DCM - Dilated Cardiomyopathy|HCM - Hypertrophic Cardiomyopathy|HOCM - Hypertrophic Obstructive Cardiomyopathy|Arrhythmogenic Right Ventricular Cardiomyopathy|Left Ventricular Noncompaction Cardiomyopathy|Amyloidosis|Inflammatory Cardiomyopathy","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"all-cause mortality","time_frame":"4 years"}]}
{"nct_id":"NCT04932538","start_date":"2020-08-15","phase":"N/A","enrollment":20,"brief_title":"Effects Of Kinesio Taping On Balance, Functionality, And Participation In Children With Cerebral Palsy?","official_title":"Kinesio Taping On Gluteal Muscles: Does It Affect Balance, Functionality, And Participation In Children With Unilateral Spastic Cerebral Palsy?","primary_completion_date":"2020-12-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2021-03-15","last_update":"2021-06-21","description":"BACKGROUND: Walking and balance problems are among the most common problems in individuals with cerebral palsy (CP). Hip abduction and extension muscle function insufficiencies are common in children with CP. OBJECTIVE: The aim of this study was to investigate the immediate and long-term effects of Kinesio Taping (KT) applied on the gluteus maximus and gluteus medius muscles on walking, functionality, balance, and participation in children with unilateral spastic CP. METHOD: This study was designed as a randomized controlled trial. The study included 20 children with unilateral spastic CP: 11 in the taping group and 9 in the control group. KT was applied in the taping group for 4 weeks in addition to a physiotherapy program. The control group received only the physiotherapy program. Body structure and functions were evaluated with the Pediatric Berg Balance Scale (PBBS). Activity was evaluated with the Timed Up and Go Test (TUG), Functional Mobility Scale (FMS), Gross Motor Function Scale (GMFM-88), the BTS G-Walk Spatiotemporal Gait Analysis System. Participation was evaluated with the Canadian Occupational Performance Measure (COPM). Evaluations were made at the beginning of the study and 30 minutes after the first tape application, and at the end of 4 weeks in the taping group. The level of significance was accepted as p<0.05.","other_id":"A7698","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Randomized Controlled Trial","sampling_method":"","gender":"All","minimum_age":6,"maximum_age":12,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  having unilateral spastic CP\r\n\r\n          -  being in an age between 6 years and 12 years;\r\n\r\n          -  being classified in levels I or II of the Gross Motor Function Classification System\r\n             (GMFCS); -having spasticity at lower extremity 2 or less according to Modified\r\n             Ashworth Scale\r\n\r\n          -  being able to follow and accept verbal instructions.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  having any orthopedic surgery or botulinum toxin injection in the past 6 months\r\n\r\n          -  having allergic reactions to the adhesive compound of Kinesio Taping\r\n      ","sponsor":"Ondokuz Mays University","sponsor_type":"Other","conditions":"Cerebral Palsy, Spastic|Gait Disorders, Neurologic|Hemiplegic Cerebral Palsy","interventions":[{"intervention_type":"Other","name":"Other: Knesio Taping","description":"Kinesio Taping (KT) is used for pediatric rehabilitation to reduce pain, facilitate or inhibit muscle activity, prevent injuries, reposition joints, aid the lymphatic system, support postural alignment, and improve proprioception"}],"outcomes":[{"outcome_type":"primary","measure":"Pediatric Berg Balance Scale (PBBS)","time_frame":"baseline and after 4 weeks","description":"Balance was evaluated with the Pediatric Berg Balance Scale (PBBS).On this scale minimum score is 0 and maximum score is 56. As the score increases, the balance improves. Between baseline and fourth week the balance change was assessed."},{"outcome_type":"primary","measure":"Timed Up and Go test (TUG)","time_frame":"baseline, 30 minutes after the first tape was applied, and at the end of the 4th week","description":"The TUG measures various components such as walking speed, postural control, functional mobility, and balance. Change in functionality was assessed between baseline, 30 minutes after the first taping, and at the fourth week."},{"outcome_type":"primary","measure":"Functional Mobility Scale (FMS)","time_frame":"baseline and after 4 weeks","description":"The walking ability of the participants was evaluated with the Functional Mobility Scale at 3 different distances (5 meters-indoor, 50 meters-school, 500 meters-community). Inter-observer reliability of the FMS, which can reveal changes that cannot be detected with the GMFCS, was also demonstrated.On this scale the minimum score is 1, and the maximum score is six. The higher the score, the better the functional status.Change in functionality was assessed between baseline and at the fourth week."},{"outcome_type":"primary","measure":"Gross Motor Function Measurement (GMFM)","time_frame":"baseline and after 4 weeks","description":"Gross motor function was assessed using dimensions D and E of the Gross Motor Function Measurement (GMFM), which consists of standing, walking, running, and jumping. The GMFM is a valid, reliable, and sensitive method, which demonstrates the change in motor functions in children with CP and other disabilities via videotape recordings. Minimum score is 0 and maximum score is 74. The higher the score, the better the functional status. Between baseline and fourth week the motor performance change was assessed."},{"outcome_type":"primary","measure":"BTS G-Walk Spatiotemporal Gait Analysis System","time_frame":"baseline, 30 minutes after the first tape was applied, and at the end of the 4th week","description":"Gait parameters were assessed using the BTS G-Walk Spatiotemporal Gait Analysis System. In this system, the analysis results of the sensor attached to the L5-S1 level of the patient was transferred to a computer via Bluetooth. This system allows gait analysis by comparing the left and right extremities with normal values, and it also enables a 3-dimensional kinematic analysis of the pelvis (11). The track length was preset as 10 meters. The children with CP were asked to walk the 10-meter track three times. Three measurements were averaged in the analysis. Change in gait parameters was assessed between baseline, 30 minutes after first taping and at the fourth week."},{"outcome_type":"primary","measure":"Canadian Occupational Performance Measure (COPM)","time_frame":"baseline and after 4 weeks","description":"Participation was assessed using the Canadian Occupational Performance Measure (COPM). The COPM is a client-centered outcome measure to identify and prioritize everyday issues that restrict individuals' participation in everyday life.There is no minimum maximum score on this scale. The pre- and post-treatment scores of the person are compared. Between baseline and fourth week the participation change was assessed."}]}
{"nct_id":"NCT04957017","start_date":"2020-08-15","phase":"N/A","enrollment":90,"brief_title":"Effect of Hand-Washing Training in Covid-19","official_title":"Effect of Training on Given to Women With Chronic Disease on Hand-Washing Behaviours, Attitudes and Nutrition During the Covid-19 Pandemic","primary_completion_date":"2021-01-25","study_type":"Interventional","rec_status":"Completed","completion_date":"2021-06-10","last_update":"2021-07-09","description":"This study was conducted in order to inform, the women with chronic disease in rural areas, about hand-washing and nutrition, and to evaluate the efficiency of the training program. A randomized-controlled trial was performed based on CONSORT checklist. 90 women in total were included in the study, 45 for each group. The women in the intervention group were given, by the researcher, the training on the importance of hand-washing and appropriate food choices. The training given to the women in rural areas created significant benefit for them to have the appropriate food choices and hand-washing behaviours.","other_id":"GO 2020/192","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"Single","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Be women, agreeing to participate.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Be man, unable to communicate.\r\n      ","sponsor":"Mehmet Akif Ersoy University","sponsor_type":"Other","conditions":"Chronic Disease|Covid-19 Pandemic","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Training","description":"After the data was collected, the women in the intervention group were trained on \"Hand-Washing and Nutrition during the COVID-19 period\". The training on hand-washing and nutrition was given using the \"Hand-Washing and Nutrition Training Guide\" prepared by the researchers, and the \"Hand-Washing and Nutrition Training Manual\" covering the content of the training, was distributed to the women at the end of the training"}],"outcomes":[{"outcome_type":"primary","measure":"The Nutritional Knowledge Level Scale for Adults (NKLSA)","time_frame":"Three months","description":"The Nutritional Knowledge Level Scale for Adults (NKLSA) developed by Batmaz in 2018 and whose validity and reliability were studied, the 20 statements under the heading \"Basic Nutritional and Food-Health Knowledge\" and 12 statements under the heading \"Food Choice\" were responded using one of the following: strongly agree, agree, neither agree nor disagree, disagree, and strongly disagree. The participants who responded the inappropriate statements by \"strongly agree\" got 0 point; those who \"agreed\" with these statements got 1 point; those who neither agreed nor disagreed got 2 points; those who disagreed got 3 points, and those who strongly disagreed with them got 4 points. The maximum score that can be obtained from the \"Basic Nutritional and Food-Health Knowledge\" is 80, and the maximum score to be obtained from the \"Food Choice\" is 48."},{"outcome_type":"primary","measure":"Social Hand-Washing Knowledge Form","time_frame":"Three months","description":"Social Hand-Washing Knowledge Form was created by the researchers by scanning the literature (Kilpatrick et al., 2018; Lynch et al., 2020; Wu et al., 2013), and the authors received expert opinions from 3 academic members for the content validity of the knowledge statements. The answers given to the questions were scored as No \"0\", Occasionally \"1\", Yes \"2\". Question 11 included in the investigators survey was reversely scored. The lowest score to be obtained from the investigators survey was 0 and the highest score was 22. As the investigators considered it more comprehensible to convert this score into a hundred scale and make the investigators evaluations over 100 points, the investigators evaluated the total score obtained by each case through converting it into a hundred scale."}]}
{"nct_id":"NCT04241822","start_date":"2020-08-15","phase":"N/A","enrollment":150,"brief_title":"Musculoskeletal Pain in Long-term Dizziness","official_title":"Musculoskeletal Pain in Long-term Dizziness- Incidence, Prognosis and Measures","primary_completion_date":"2022-10-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2025-12-31","last_update":"2020-05-20","description":"This project is aimed at patients with dizziness believed to be due to conditions in the balance organ in the inner ear (vestibular diseases). Dizziness can be bothersome and influence postural control negatively, and can cause secondary musculoskeletal disorders. Dizziness can also result in reduced work capacity. The purpose of the project is to strengthen the knowledge base regarding symptom burden, prognosis and treatment of prolonged dizziness. The hypothesis is that musculoskeletal pain at baseline is a prognostic factor for prolonged dizziness.","other_id":"6849","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"After 1 year participants who still have dizziness complaints will be offered one of two interventions:\r\nGroup-based vestibular rehabilitation combining cognitive intervention, vestiular exercises and body awareness therapy\r\nExergaming intervention with virtual reality exercises using data games and videos, and other balance exercises.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":67,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients referred to an otorhinolaryngological university clinic due to suspected\r\n             vestibular disorders (dizziness)\r\n\r\n          -  Patients must be bothered with dizziness at the time of consultation\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients uable to fill in questionnaires due language barriers\r\n\r\n          -  Patients not able to undergo diagnostic and testing procedures\r\n\r\n          -  Patients with vestibular Schwannoma\r\n\r\n          -  Patients with diving-related inner ear injuries\r\n      ","sponsor":"Western Norway University of Applied Sciences","sponsor_type":"Other","conditions":"Vestibular Disease|Musculoskeletal Pain|Rehabilitation","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Vestibular exercises combined with body awareness exercises and cognitive therapy","description":"The intervention is group based and is a combination of information/education, vestibular exercises (head movements and gaze stability exercises) body awareness exercises and cognitive therapy"},{"intervention_type":"Behavioral","name":"Behavioral: Exergaming","description":"The intervention consists of different balance exercises using non-immersive virtual reality"}],"outcomes":[{"outcome_type":"primary","measure":"Dizziness Handicap Inventory. 0-100 (high score worst)","time_frame":"Baseline, 26 weeks, 1 year, through study completion, an average 18 months","description":"Baseline status and change in dizziness handicap"},{"outcome_type":"secondary","measure":"Nordic Pain Questionnaire. 0-10 (high score worst)","time_frame":"Baseline, 26 weeks, 1 year, through study completion, an average 18 months","description":"Baseline status and change in musculoskeletal pain"},{"outcome_type":"secondary","measure":"Vertigo Symptom Scale. 0-60 (high score worst)","time_frame":"Baseline, 26 weeks, 1 year, through study completion, an average 18 months","description":"Baseline status and change in vertigo symptoms"},{"outcome_type":"secondary","measure":"RAND-12 health related quality of life. 0-60 (high score better)","time_frame":"Baseline, 26 weeks, 1 year","description":"Baseline status and change in health related quality of life"},{"outcome_type":"secondary","measure":"Hospital Anxiety and Depression Scale. 0-42 (high score worst)","time_frame":"Baseline, 26 weeks, 1 year","description":"Baseline status and change in anxiety and depression symptoms"},{"outcome_type":"secondary","measure":"Dizziness Catastrophising Scale. 0-52 (high score worst)","time_frame":"Baseline, 26 weeks, 1 year, through study completion, an average 18 months","description":"Baseline status and change in catastrophising thoughts about the dizziness"},{"outcome_type":"secondary","measure":"Posturography. Body sway while standing on a force platform.","time_frame":"Baseline,1 year, through study completion, an average 18 months","description":"Baseline status and change after intervention"},{"outcome_type":"secondary","measure":"Four tests of Body flexibility derived from the Global Physiotherapy Examination- 52","time_frame":"Baseline,1 year, through study completion, an average 18 months","description":"Baseline status and change after intervention"},{"outcome_type":"secondary","measure":"Walking test preferred speed, 6 m (m/s)","time_frame":"Baseline,1 year, through study completion, an average 18 months","description":"Baseline status and change after intervention"},{"outcome_type":"secondary","measure":"Walking test fast speed, 6 m (m/s)","time_frame":"Baseline,1 year, through study completion, an average 18 months","description":"Baseline status and change after intervention"},{"outcome_type":"secondary","measure":"Grip Strength","time_frame":"Baseline","description":"Baseline"}]}
{"nct_id":"NCT04326101","start_date":"2020-08-15","enrollment":9,"brief_title":"Electronic Transmission of Laboratory and Adherence Records of Heart Failure Patients to General Practitioners Screen","official_title":"Patient NT-proBNP Values and Medication Adherence on Their GP's Screen to Guide Dose Adjustment in Heart Failure (LabAdhDoc)","primary_completion_date":"2021-10-15","study_type":"Observational","rec_status":"Recruiting","completion_date":"2021-12-30","last_update":"2021-07-28","description":"Patients with heart failure (HF) need multiple guideline-directed medications to control the systolic and/or diastolic ventricular dysfunction. Laboratory measure the biomarker NT-proBNP (N-terminal pro-B type natriuretic peptide) to support clinical decision and to guide treatment at every stage of HF. Many patients (including HF patients) do not follow therapeutic recommendations. Electronic monitoring of medication intake gives precise information over time and is the gold standard to unveil inappropriate behaviour. Electronic Health Records (EHR) are repository of patient health data in digital format and are mostly locally configured in medical practices. We aim to transmit laboratory results of NT-proBNP and estimates of medication adherence into the EHR system of primary care providers, with the objective to guide treatment and dose adjustment of multiple medications in patients with HF. Our project is *not* to develop a telemonitoring system.","other_id":"2019-01248","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","population":"suffers from heart failure NYHA II-III","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  is  18 years old;\r\n\r\n          -  was diagnosed with HF NYHA II-III;\r\n\r\n          -  is under multiple regimen (ACE-Inhibitors and/or mineralocorticoid receptor antagonist\r\n             (MRA) and/or betablocker (BB) and/or diuretic and/or other);\r\n\r\n          -  did not reach targeted clinical and/or biomedical objectives (HF is inadequately\r\n             controlled);\r\n\r\n          -  self-administers medication (no help or supervision from a third person);\r\n\r\n          -  is suspected of inappropriate intake behaviour;\r\n\r\n          -  accepts to use the monitoring device for one month;\r\n\r\n          -  accepts a home-visit from the study pharmacist one month later;\r\n\r\n          -  signs the informed consent form.\r\n\r\n        Exclusion Criteria:\r\n\r\n        - Patients who are, in the opinion of the physician, unlikely to comply with the study\r\n        schedule or are unsuitable for any other reason\r\n      ","sponsor":"University Hospital, Basel, Switzerland","sponsor_type":"Other","conditions":"Heart Failure","interventions":[{"intervention_type":"Other","name":"Other: Transmission of adherence records","description":"Electronic transmission of patient adherence records by pharmacists into medical EHR (Electronic Health Records)"}],"outcomes":[{"outcome_type":"primary","measure":"Successful transmission","time_frame":"one month","description":"The adherence records transmitted by the pharmacy are available in the health records system of GPs"},{"outcome_type":"secondary","measure":"Physician satisfaction","time_frame":"through study completion, 1 year","description":"Satisfaction of physician with the availability of adherence records in his/her health records system"}]}
{"nct_id":"NCT04408885","start_date":"2020-08-15","enrollment":400,"brief_title":"Rehabilitation Treatment of Anterior Cruciate Ligament Rupture","official_title":"Rehabilitation Treatment of Anterior Cruciate Ligament Rupture","primary_completion_date":"2027-12-31","study_type":"Observational [Patient Registry]","rec_status":"Recruiting","completion_date":"2030-12-31","last_update":"2020-11-17","description":"The purpose with this present study is to investigate the effect og a non-surgical regime in patients with an Anterior Cruciate ligament injury. The effect will be measured by patient reported outcome scores, level of function and how many of the patients are converting to operative treatment.","other_id":"Danish EC: 1-10-72-25-20","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":50,"population":"We will include 400 patients with Anterior cruciate ligament injury. Patients will be\r\n        included at different orthopaedic Clinics at 5 hospitals in Region Midtjylland.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Anterior cruciate ligament injury where rehabilitation regime is selected as\r\n             treatment.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Other knee ligament instability\r\n\r\n          -  Rheumatoid arthritis\r\n\r\n          -  Morbus Bechterews Disease\r\n      ","sponsor":"Aarhus University Hospital","sponsor_type":"Other","conditions":"ACL Injury","interventions":[{"intervention_type":"Other","name":"Other: Rehabilitation","description":"Non-surgical interventions to patients with an Anterior cruciate ligament injury. Rehabilitation regime is the regime provided by the physician at the rehabilitation clinic."}],"outcomes":[{"outcome_type":"primary","measure":"Changes in patient reported outcome score (IKDC)","time_frame":"Baseline - 2 Years","description":"The International Knee Documentation Committee (0-100)"},{"outcome_type":"secondary","measure":"Changes in patient reported outcome score (KOOS)","time_frame":"Baseline - 2 Years","description":"Knee injury and Osteoarthritis Outcome Score (0-100)"},{"outcome_type":"secondary","measure":"Changes in patient reported outcome score (KNEES-ACL)","time_frame":"Baseline - 2 Years","description":"Knee Numeric-Entity Evaluation Score (0-100)"},{"outcome_type":"secondary","measure":"Changes in patient reported outcome score (TEGNER)","time_frame":"Baseline - 2 Years","description":"Activity scale (0-10)"}]}
{"nct_id":"NCT04529005","start_date":"2020-08-13","phase":"Phase 4","enrollment":20,"brief_title":"Angiotensin II in the Perioperative Management of Hypotension in Kidney Transplant Recipients","official_title":"Angiotensin II in the Perioperative Management of Hypotension in Kidney Transplant","primary_completion_date":"2021-08-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2021-08-01","last_update":"2021-08-16","description":"The current standard of catecholamine vasopressor management of perioperative hypotension in kidney transplant patients carries significant risks and falls short in many ways. Currently, there is an absence in the scientific literature and research describing the hemodynamic effectiveness and safety of novel pharmacologic agents such as angiotensin II (Giapreza - Ang II) in perioperative kidney transplant patients. Phase 3 registration trials have demonstrated the superior safety and efficacy of Ang II (Giapreza) in distributive shock patients compared to traditional vasopressor agents and the novel mechanism of action may provide additional protection in renal transplant patients. The pilot study entails giving informed and consenting kidney transplant recipients Ang II (Giapreza) as their first vasopressor if the need for vasopressors emerge either intraoperatively or postoperatively in kidney transplant recipients. The primary objective is to evaluate the safety and hemodynamic effects of Ang II (Giapreza) in the renal transplant population.","other_id":"2020-0526","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adult patients > 18 years of age\r\n\r\n          -  Receiving deceased donor kidney transplant\r\n\r\n          -  Pre-transplant Ejection Fraction (within past 18 months) > 50%\r\n\r\n          -  Intraoperative or postoperative distributive shock (according to hospital and study\r\n             protocol) requiring vasopressor support\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnant patients (they would be excluded from receiving a transplant)\r\n\r\n          -  Prisoners\r\n\r\n          -  History of mesenteric ischemia\r\n\r\n          -  History of aortic dissection\r\n\r\n          -  History of abdominal aortic aneurysm\r\n\r\n          -  Allergy to mannitol\r\n\r\n          -  Absolute neutrophil count < 1000 cell/mm3 (within past 18 months)\r\n\r\n          -  Diagnosis of Raynaud's phenomenon, systemic sclerosis or vasospastic disease\r\n      ","sponsor":"University of Illinois at Chicago","sponsor_type":"Other","conditions":"Shock, Surgical|Shock|Hypotension and Shock|Kidney Transplant; Complications|Intraoperative Hypotension|Postoperative Hypotension","interventions":[{"intervention_type":"Drug","name":"Drug: Angiotensin II","description":"If intraoperative or postoperative hypotension occurs (e.g. SBP < 120 mmHg) and the attending surgeon and/or attending anesthesiologist deems vasopressor therapy to be necessary, angiotensin II (Giapreza) will be the first vasopressor used for management."}],"outcomes":[{"outcome_type":"primary","measure":"Blood Pressure - Intraoperative","time_frame":"From date and time of study drug initiation during transplant operation until goal BP is attained (per ordering surgeon) to a maximum of 8 hours","description":"Intraoperative - time to attainment of goal BP after starting AT2"},{"outcome_type":"primary","measure":"Blood Pressure - Postoperative","time_frame":"From date and time of study drug initiation after transplant operation until goal BP is attained (per ordering surgeon) up to a maximum of 24 hours","description":"Postoperative - time to attainment of goal BP after starting AT2"},{"outcome_type":"secondary","measure":"Arrhythmias","time_frame":"From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days.","description":"Confirmed via EKG, flowsheet, or note documentation"},{"outcome_type":"secondary","measure":"Peripheral/visceral ischemia","time_frame":"From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days.","description":"Digital or other peripheral/visceral ischemia"},{"outcome_type":"secondary","measure":"Thrombosis","time_frame":"From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days.","description":"Incidence of venous or arterial thrombosis occurring during the hospitalization for kidney transplant (captured by ultrasound or other diagnostic imaging)"},{"outcome_type":"secondary","measure":"Fungal Infections","time_frame":"From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days.","description":"Incidence of post-operative fungal infections prior to discharge (as documented by the clinical care team)"},{"outcome_type":"secondary","measure":"Hyperglycemia","time_frame":"From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days.","description":"Incidence of hyperglycemia requiring use of an insulin infusion"},{"outcome_type":"secondary","measure":"Acidemia","time_frame":"From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days.","description":"Incidence of pH < 7.2"},{"outcome_type":"secondary","measure":"Vasopressor outcomes","time_frame":"Intraoperatively and 72 hour postoperatively","description":"Incidence of the need for additional vasopressor agents"},{"outcome_type":"secondary","measure":"Serum creatinine - 1st post-op","time_frame":"First SCr after the end of transplant surgery up to 24 hours after surgery is completed"},{"outcome_type":"secondary","measure":"Serum creatinine - 7 days post-op","time_frame":"SCr at postop day 7"},{"outcome_type":"secondary","measure":"Serum creatinine - discharge","time_frame":"SCr at discharge up to a maximum of 30 days"}]}
{"nct_id":"NCT04514016","start_date":"2020-08-12","enrollment":64,"brief_title":"Cross Sectional CFAR HIV/COVID-19 Study","official_title":"Cross Sectional Survey Of Severe Acute Respiratory Syndrome (SARS) Coronavirus 2 (COV-2) Infection And Seroprevalence In A Cohort Of HIV-Infected Children, Youth, And Adolescents","primary_completion_date":"2021-03-17","study_type":"Observational","rec_status":"Completed","completion_date":"2021-03-17","last_update":"2021-03-23","description":"The main purpose of this research study is to learn the rate of SARS COV-2 on HIV infected children, adolescents, and youth receiving their primary HIV care at the University of Miami Miller School of Medicine.","other_id":"20200802","observational_model":"Cohort","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":3,"maximum_age":25,"population":"HIV-positive pediatric, adolescent or young adult being treated at Batchelor Children\r\n        Research Institute (BCRI) at the University of Miami.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Being a patient to the Pediatric or Adolescent clinic located at Batchelor Children\r\n             Research Institute (BCRI)\r\n\r\n          -  Being diagnosed with HIV infection by the time of enrollment\r\n\r\n          -  At enrollment, 3 to < 26 years\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patient will be excluded from the study if any of the following are identified:\r\n\r\n          -  Patients under legal age and in the State's custody\r\n\r\n          -  Participant or legal guardian unable to sign Informed Consent forms\r\n\r\n          -  Participant unable to complete study visits\r\n      ","sponsor":"University of Miami","sponsor_type":"Other","conditions":"SARS-CoV Infection|Covid19","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Number of participants who tested positive with SARS COV-2 antibody","time_frame":"month 3","description":"SARS COV-2 antibody will be analyzed from blood samples via serological assay"},{"outcome_type":"primary","measure":"Number of participants who tested positive with SARS COV-2 Infection","time_frame":"month 3","description":"SARS COV-2 Infection will be analyzed from nasopharyngeal swab samples via RT-PCR assay"}]}
{"nct_id":"NCT04478708","start_date":"2020-08-07","phase":"Phase 1","enrollment":100,"brief_title":"Single and Multiple Ascending Dose Study of AMG 133 in Participants With Obesity","official_title":"A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 133 in Subjects With Obesity","primary_completion_date":"2022-04-10","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-04-10","last_update":"2021-08-20","description":"The study aims to assess the safety and tolerability of AMG 133 as single and multiple doses in participants with obesity","other_id":"20180048","allocation":"Randomized","intervention_model":"Sequential Assignment","primary_purpose":"Basic Science","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Participant has provided informed consent before initiation of any study-specific\r\n             activities/procedures.\r\n\r\n          -  Age  18 years to  65 years, at the time of signing the informed consent.\r\n\r\n          -  Except for obesity, otherwise healthy as determined by the investigator or medically\r\n             qualified designee based on a medical evaluation including medical history, physical\r\n             examination, laboratory tests, and ECGs on day -2 (cohorts 1-6, cohort 11) or day -1\r\n             (cohorts 7-10) and screening.\r\n\r\n          -  Body mass index between  30.0 kg/m^2 and  40.0 kg/m^2.\r\n\r\n          -  Have a stable body weight (< 5 kg self-reported change during the previous 8 weeks)\r\n             before screening.\r\n\r\n          -  Willing to maintain current general diet and physical activity regimen, except for the\r\n             physical activity in the 72 hours before each blood sample collection for the clinical\r\n             laboratory analysis, which should not be strenuous.\r\n\r\n          -  Females must be of nonreproductive potential\r\n\r\n              Postmenopausal as defined as:\r\n\r\n          -  Age of  55 years with no menses for at least 12 months; OR\r\n\r\n          -  Age < 55 years with no menses for at least 12 months AND with a follicle-stimulating\r\n             hormone level > 40 IU/L or according to the definition of \"postmenopausal range\" for\r\n             the laboratory involved; OR\r\n\r\n               -  History of hysterectomy; OR\r\n\r\n               -  History of bilateral oophorectomy.\r\n\r\n          -  For patients in cohorts 7 - 10 only, participants must have a smartphone device with\r\n             the capability of downloading apps or other digital tools required for this cohort.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History or clinical evidence of diabetes mellitus, including hemoglobin A1c (HbA1c) >\r\n             6.5% and/or a fasting glucose  125 mg/dl (6.9 mmol/L) at screening.\r\n\r\n          -  Triglycerides  5.65 mmol/L (ie, 500 mg/dL) at screening.\r\n\r\n          -  Screening calcitonin  50 ng/L.\r\n\r\n          -  Hepatic liver enzymes aspartate aminotransferase, alanine aminotransferase, alkaline\r\n             phosphatase, or total bilirubin levels > 1.5 times the upper limit of normal (ULN) at\r\n             screening.\r\n\r\n          -  History or clinical evidence of bleeding diathesis or any coagulation disorder,\r\n             including prothrombin time, activated partial thromboplastin time, international\r\n             normalized ratio, or platelet count outside of the laboratory's normal reference range\r\n             at screening.\r\n\r\n          -  History of gastrointestinal abnormality that could affect gastrointestinal motility\r\n             (including small bowel or colonic resection, inflammatory bowel disease, irritable\r\n             bowel disease, and colon or gastrointestinal tract cancer).\r\n\r\n          -  Participants with a family or personal history of medullary thyroid carcinoma or\r\n             multiple endocrine neoplasia type 2 or a personal history of nonfamilial medullary\r\n             thyroid carcinoma.\r\n\r\n          -  Participants with a history of confirmed chronic pancreatitis or idiopathic acute\r\n             pancreatitis.\r\n\r\n          -  Participants with a history of gall bladder disease (ie, cholelithiasis or\r\n             cholecystitis) not treated with cholecystectomy.\r\n\r\n          -  Untreated or uncontrolled hypothyroidism/hyperthyroidism defined as thyroid\r\n             stimulating hormone > 6 mIU/L or <0.4 mIU/L.\r\n\r\n          -  A corrected QT interval (QTc) at screening of > 450 msec in males or > 470 msec in\r\n             females or history of long QT syndrome.\r\n\r\n          -  Participants with a history of renal impairment or renal disease and/or estimated\r\n             glomerular filtration rate  60 mL/min/1.73 m^2.\r\n\r\n          -  Obesity induced by other endocrinologic disorders (eg, Cushing's Syndrome).\r\n\r\n          -  Previous surgical treatment for obesity (excluding liposuction if performed >1 year\r\n             before study entry) and/or participants with recent (within 6 months) or planned\r\n             endoscopic treatment for obesity.\r\n\r\n          -  History of major depressive disorder.\r\n\r\n          -  History of other severe psychiatric disorders, eg schizophrenia, bipolar disorder.\r\n\r\n          -  Any lifetime history of a suicidal attempt or of any suicidal behavior.\r\n\r\n          -  Surgery scheduled for the study duration period, except for minor surgical procedures,\r\n             at the discretion of the investigator.\r\n\r\n          -  Positive results for human immunodeficiency virus antibodies, hepatitis B surface\r\n             antigen, hepatitis B core antibody, or hepatitis C virus RNA. For hepatitis C,\r\n             hepatitis C antibody testing is done at screening, followed by hepatitis C virus RNA\r\n             by polymerase chain reaction if hepatitis C antibody is positive.\r\n\r\n          -  Systolic blood pressure  150 mm Hg or diastolic blood pressure  90 mm Hg at\r\n             screening, or on day -2. For each visit, if the initial blood pressure is elevated,\r\n             the reading may be repeated once at least 15 minutes later and the lower of the 2\r\n             readings may be used.\r\n\r\n          -  History of malignancy of any type, other than in situ cervical cancer or surgically\r\n             excised nonmelanomatous skin cancers occurring more than 5 years before randomization.\r\n\r\n          -  Use of the following agents are excluded unless there is a prior consultation between\r\n             the investigator and Amgen medical monitor:\r\n\r\n               -  Prescription and nonprescription drugs within 14 days or 5 half-lives, whichever\r\n                  is longer, before the first dose of investigational product, with exception of\r\n                  hormone replacement therapy (eg, estrogen, thyroid).\r\n\r\n               -  All herbal medicines, vitamins, and supplements within 30 days before receiving\r\n                  the first dose of investigational product.\r\n\r\n               -  Exceptions must be reviewed and approved by the investigator and Amgen medical\r\n                  monitor. Written documentation of this review and Amgen acknowledgment is\r\n                  required for participant participation.\r\n\r\n          -  Current or history of treatment with medications that may cause significant weight\r\n             gain or loss, within 3 months before screening, including systemic corticosteroids\r\n             (except for a short course of treatment, ie, 7 to 10 days), tricyclic antidepressants,\r\n             atypical antipsychotic and mood stabilizers (eg, imipramine, amitriptyline,\r\n             mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine,\r\n             olanzapine, valproic acid and its derivatives, and lithium).\r\n\r\n          -  Current participation (or within the last 3 months) in an organized weight reduction\r\n             program or currently using or used within 3 months before screening: pramlintide,\r\n             sibutramine, orlistat, zonisamide, topiramate, phentermine, naltrexone, bupropion,\r\n             lorcaserin, metformin, or any GLP-1R agonists (either by prescription or as part of a\r\n             clinical study).\r\n\r\n          -  Prior exposure to AMG 133 or AMG 598 or currently receiving treatment in another\r\n             investigational device or drug study, or less than 5 half-lives since ending treatment\r\n             on another investigational device or drug study(ies). Other investigational procedures\r\n             while participating in this study are excluded.\r\n\r\n          -  Female participants with a positive pregnancy test assessed at screening and/or day -2\r\n             by a serum pregnancy test and/or urine pregnancy test) or female participants who are\r\n             breastfeeding or planning to become pregnant or breastfeed during treatment and for an\r\n             additional 5 months after the last dose of AMG 133.\r\n\r\n          -  Male participants with a female partner of childbearing potential who are unwilling to\r\n             practice sexual abstinence (refrain from heterosexual intercourse) or use an\r\n             acceptable method of contraception during treatment and for an additional 5 months\r\n             after the last dose of AMG 133.\r\n\r\n          -  Male participants unwilling to abstain from donating sperm during treatment and for an\r\n             additional 5 months after the last dose of AMG 133.\r\n\r\n          -  Participant has known sensitivity to AMG 133 or components thereof or a history of\r\n             drug or other allergy that is in the opinion of the investigator or medical monitor\r\n             (if appropriate), contraindicates their participation.\r\n\r\n          -  Participant has a known sensitivity to GLP-1R agonists.\r\n\r\n          -  Participant has known sensitivity to mammalian derived products.\r\n\r\n          -  Participant has an allergy or known sensitivity to acetaminophen.\r\n\r\n          -  Participant is unwilling or unable to limit alcohol consumption throughout the course\r\n             of the study. Alcohol is prohibited 48 hours before day -2 and is limited to no more\r\n             than to 2 drinks per day for males and 1 drink per day for females for the duration of\r\n             the study (1 drink being equivalent to 12 ounces of regular beer, 8 to 9 ounces of\r\n             malt liquor, 5 ounces of wine, or 1.5 ounces of 80 proof distilled spirits).\r\n\r\n          -  Participant uses nicotine or tobacco containing products (including but not limited\r\n             to: snuff, chewing tobacco, cigars, cigarettes, e-cigarettes, pipes, or nicotine\r\n             patches) within 6 months before screening. Participant is unwilling or unable to\r\n             abstain from nicotine or tobacco, cigars, cigarettes, pipes, or nicotine patches\r\n             throughout the course of the study.\r\n\r\n          -  Participant is tested positive for alcohol and/or drugs of abuse at screening.\r\n\r\n          -  History of substance abuse (ie, alcohol, licit or illicit drugs) within 12 months\r\n             before screening.\r\n\r\n          -  Participant is unwilling to refrain from strenuous exercise (eg, heavy lifting, weight\r\n             training, and aerobics) for 72 hours before each blood collection for clinical\r\n             laboratory tests.\r\n\r\n          -  Participant has donated or lost  500 mL of blood or plasma within 60 days of day -2.\r\n\r\n          -  Participant likely to not be available to complete all protocol-required study visits\r\n             or procedures, and/or to comply with all required study procedures to the best of the\r\n             participant and investigator's knowledge.\r\n\r\n          -  History or evidence of any other clinically significant disorder, condition or disease\r\n             (with the exception of those outlined above) that, in the opinion of the investigator\r\n             or Amgen physician, if consulted, would pose a risk to participant safety or interfere\r\n             with the study evaluation, procedures or completion.\r\n\r\n          -  For participants in cohorts 7 - 10 only, the Patient Health Questionnaire-9 (PHQ-9)\r\n             score of  10 up to day 1.\r\n\r\n          -  For participants in cohorts 7 - 10 only, any suicidal ideation as identified by\r\n             endorsement of (answered yes to) any of the items numbered 1-5 on the Columbia Suicide\r\n             Severity Rating Scale (C-SSRS) up to day 1.\r\n\r\n          -  For participants in cohorts 7 - 10 only, participant has systolic blood pressure  150\r\n             mm Hg or diastolic blood pressure  95 mm Hg on day 1. For each visit, if the initial\r\n             blood pressure is elevated, the reading may be repeated once at least 15 minutes later\r\n             and the lower of the 2 readings may be used.\r\n\r\n          -  For participants in cohorts 7 - 10 only, a QTc of > 450 msec in males or > 470 msec in\r\n             females up to day 1.\r\n      ","sponsor":"Amgen","sponsor_type":"Industry","conditions":"Obesity","interventions":[{"intervention_type":"Drug","name":"Drug: Placebo","description":"Participants will receive placebo as a single dose in Part A and multiple doses in Part B."},{"intervention_type":"Biological","name":"Biological: AMG 133","description":"Participants will receive AMG 133 as a single dose in Part A and multiple doses in Part B."}],"outcomes":[{"outcome_type":"primary","measure":"Part A: Number of Participants with Treatment-emergent Adverse Events (TEAEs)","time_frame":"Up to 150 days"},{"outcome_type":"primary","measure":"Part B: Number of Participants with Treatment-emergent Adverse Events (TEAEs)","time_frame":"Up to 207 days"},{"outcome_type":"primary","measure":"Part A: Number of Participants with Clinically Significant Laboratory Values","time_frame":"Up to 150 days"},{"outcome_type":"primary","measure":"Part B: Number of Participants with Clinically Significant Laboratory Values","time_frame":"Up to 207 days"},{"outcome_type":"primary","measure":"Part A: Number of Participants with Clinically Significant Changes in Vital Signs","time_frame":"Up to 150 days"},{"outcome_type":"primary","measure":"Part B: Number of Participants with Clinically Significant Changes in Vital Signs","time_frame":"Up to 207 days"},{"outcome_type":"primary","measure":"Part A: Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Measurements","time_frame":"Up to 150 days"},{"outcome_type":"primary","measure":"Part B: Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Measurements","time_frame":"Up to 207 days"},{"outcome_type":"secondary","measure":"Part A and B: Maximum Plasma Concentration (Cmax)","time_frame":"Part A: Up to 150 days; Part B: Up to 207 days"},{"outcome_type":"secondary","measure":"Part A and B: Time to Maximum Plasma Concentration (Tmax)","time_frame":"Part A: Up to 150 days; Part B: Up to 207 days"},{"outcome_type":"secondary","measure":"Part A and B: Area Under the Plasma Concentration-time Curve (AUC)","time_frame":"Part A: Up to 150 days; Part B: Up to 207 days"},{"outcome_type":"secondary","measure":"Part A and B: Number of Participants with Anti-AMG 133 Antibody Formation","time_frame":"Part A: Up to 150 days; Part B: Up to 207 days"}]}
{"nct_id":"NCT03634917","start_date":"2020-08-05","phase":"Phase 3","enrollment":84,"brief_title":"Investigation of the Efficacy of Acamprosate and Calcium in Comparison to Placebo as Validation of a Behavioural Test for Alcohol Dependence","official_title":"Investigation of the Efficacy of Acamprosate and Calcium in Comparison to Placebo as Validation of a Behavioural Test for Alcohol Dependence (TEMACA)","primary_completion_date":"2022-10-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-02-28","last_update":"2021-08-19","description":"Validation of a Test System to develop new medications for alcoholism (TEMA) The 'TEMA', a progressive-work alcohol self-administration paradigm, can be validated by reproducing the effect of Acamprosate and prove the effect of Calcium to reduce motivation to work for alcohol after 14 - 19 days of treatment during a period of 15 - 20 days of alcohol abstinence in a randomized, double-blind, placebo-controlled three-arm parallel-group design.","other_id":"TUD-TEMACA-069","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":25,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. male and female volunteers aged 25 to 55 years, who meet or met the diagnostic\r\n             criteria of an at least mild alcohol use disorder (DSM-5), but do not want to cease\r\n             alcohol consumption\r\n\r\n          2. willingness to stop alcohol and drug consumption for 15-20 days for the purpose of\r\n             study participation\r\n\r\n          3. at least high risky alcohol drinkers (WHO) in the Timeline Follow-back Interview over\r\n             the last 45 day with an average amount of alcohol of 60 g/day (men) or 40 g/day\r\n             (women) with at least 4 drinking days per week\r\n\r\n          4. informed consent\r\n\r\n          5. ability to swallow a placebo capsule\r\n\r\n          6. not more than 6 consecutive alcohol abstinent days between screening and visit 2\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Current Substance dependence (illegal drugs) ICD-10 or DSM-IV\r\n\r\n          2. Intention to stop alcohol consumption immediately and permanently\r\n\r\n          3. Current or previous disease that could cause a clinically relevant hazard (e.g.\r\n             pancreatitis, cirrhosis)\r\n\r\n          4. kidney stone disease\r\n\r\n          5. Current Treatment with psychotropic drugs or current psychiatric disorder in need of\r\n             treatment\r\n\r\n          6. alcohol withdrawal symptoms (at Screening, visit 1 or visit 2) with CIWA-Ar-Score > 6\r\n             points or arterial blood pressure >160 mm Hg or diastolic blood pressure > 100 mm Hg\r\n             or heart rate >105 bpm (when breath alcohol concentration 0 mg%)\r\n\r\n          7. history of epileptic seizure or delirium\r\n\r\n          8. routine laboratory parameters, indicating relevant liver-, pancreas- or kidney injury,\r\n             an acute infection, anemia or lack of vitamins (ASAT, ALAT, lipase > threefold of the\r\n             standard at screening, Quick's value < 70%, creatinine > 120 mol/l, eGFR < 30\r\n             mol/min/1.73 m, leucocytes > 13000/l, haemoglobin < 7.5 mmol/l (men) or 6.5 mmol/l\r\n             (women), MCV > 105 fl, calcium level at screening > 2.7 mmol/l\r\n\r\n          9. body weight > 120 kg (Screening)\r\n\r\n         10. Breath alcohol concentration at screening or visit 1 or visit 2 two times > 0 mg% or\r\n             drug screening two times positive for opiate, cannabis, cocaine, amphetamine,\r\n             benzodiazepine\r\n\r\n         11. history of hypersensitivity to alcohol or one of the used medicinal products, of their\r\n             ingredients or medicinal products with similar chemical structures\r\n\r\n         12. history of inefficient treatment with Acamprosate\r\n\r\n         13. participation in another clinical trial within the last 4 weeks before inclusion\r\n\r\n         14. disorders, which will not allow the subject to assess the character and importance or\r\n             possible consequences of the clinical trial\r\n\r\n         15. pregnant or breastfeeding women\r\n\r\n         16. women capable of bearing children, except women who fulfil following criteria:-\r\n             post-menopausal (12 months natural amenorrhoea or 6 month amenorrhoea and Serum FSH\r\n             >40 ml U/ml) - post operative (6 weeks after ovariectomy on both sides with or without\r\n             hysterectomy) - regular and correct use of a contraceptive method with an error Quote\r\n             of < 1 % per year (for example implants, depot injections, oral contraceptive, IUP).\r\n             It has to be recognized that a combined oral contraception - in contrast to pure\r\n             progesterone compounds - have a failure rate of < 1 %. Hormone IUDs with a Pearl Index\r\n             of 1 % are safer than copper IUDs. - sexual abstinence - vasectomy of the Partner)\r\n\r\n         17. participant is not expected to comply with the protocol (for example lacking\r\n             compliance)\r\n\r\n         18. less than 200 cumulative work trials for alcohol (in constant attention task) on 1st\r\n             alcohol self-administration day\r\n\r\n         19. specific contraindications for Acamprosate or Calcium Carbonate (according prescribing\r\n             information)\r\n\r\n               1. hypercalcemia, e.g. due to hyperparathyroidism, overdosage vitamin D,\r\n                  paraneoplastic\r\n\r\n               2. renal insufficiency (eGFR < 30ml/min/1.73m), creatinine >120 mol/l\r\n\r\n         20. intake of Vitamin D compounds or cardioactive glycosides\r\n      ","sponsor":"Technische Universitt Dresden","sponsor_type":"Other","conditions":"Alcoholism","interventions":[{"intervention_type":"Drug","name":"Drug: Acamprosate Calcium","description":"1 capsule with 666 mg Acamprosate"},{"intervention_type":"Drug","name":"Drug: Calcium Carbonate","description":"1 capsule with 1500 mg Calcium Carbonate"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"1 Capsule with Placebo (lactose monohydrate, micro crystalline cellulose, magnesium stearate)"},{"intervention_type":"Drug","name":"Drug: Placebo lead in","description":"1 Capsule with Placebo (lactose monohydrate, micro crystalline cellulose, magnesium stearate)"}],"outcomes":[{"outcome_type":"primary","measure":"Difference between cumulative CAT trials for alcohol on 1st alcohol self-administration (ASA) day and 2nd ASA day","time_frame":"18 to 31 days between 1st and 2nd measurement","description":"Each alcohol request requires prior work according to a progressive schedule (i.e., runs of the constant attention task) to earn the next alcohol infusion.\r\nPrimary outcome measure is the difference in the cumulative number of work sets for alcohol in the \"constant attention task\" (CAT) between first alcohol self-administration day (baseline, without medication, visit 2) and the second alcohol self-administration day (after 14-19 days medication, visit 5).\r\nComparison between:\r\nAcamprosate and Placebo and\r\nCalcium Carbonate and Placebo"},{"outcome_type":"secondary","measure":"Difference between \"break points\" for alcohol on 1st alcohol self-administration (ASA) day and 2nd ASA day","time_frame":"18 to 31 day between 1st and 2nd measurement","description":"The \"break point\" is the number of the last alcohol request before subjects stop to work for more alcohol."},{"outcome_type":"secondary","measure":"Difference between max. achieved blood alcohol concentrations (BAC) on 1st alcohol self-administration (ASA) day and 2nd ASA day","time_frame":"18 to 31 day between 1st and 2nd measurement","description":"Max. BAC during alcohol self-administration"},{"outcome_type":"secondary","measure":"Difference between cumulative CAT trials for sodium chloride on 1st alcohol self-administration (ASA) day and 2nd ASA day.","time_frame":"18 to 31 days between 1st and 2nd measurement","description":"Sodium chloride is an alternative reinforcer on alcohol self-administration.\r\nEach Sodium chloride request requires prior work according to a progressive schedule (i.e., runs of the constant attention task) to earn the next sodium chloride infusion.\r\nOutcome measure is the difference in the cumulative number of work sets for sodium chloride (as an alternative reinforce) in the \"constant attention task\" (CAT) between first alcohol self-administration day (baseline, without medication, visit 2) and the second alcohol self-administration day (after 14-19 days medication, visit 5)."},{"outcome_type":"secondary","measure":"Differences in 1st and 2nd half of self-administration periods between cumulative CAT trials for alcohol on 1st alcohol self-administration (ASA) day and 2nd ASA day of 1st and 2nd half of self-administration periods.","time_frame":"18 to 31 days between 1st and 2nd measurement","description":"Each alcohol request requires prior work according to a progressive schedule (i.e., runs of the constant attention task) to earn the next alcohol infusion.\r\nOutcome measure is the difference in the cumulative number of work sets for alcohol in the \"constant attention task\" (CAT) between first alcohol self-administration day (baseline, without medication, visit 2) and the second alcohol self-administration day (after 14-19 days medication, visit 5), considering the 1st and 2nd half of the self-administration period separately"},{"outcome_type":"secondary","measure":"Differences in 1st and 2nd half of self-administration periods between \"break points\" for alcohol on 1st alcohol self-administration (ASA) day and 2nd ASA day.","time_frame":"18 to 31 days between 1st and 2nd measurement","description":"The \"break point\" is the number of the last alcohol request before subjects stop to work for more alcohol.\r\nOutcome measure is the the difference in break points for alcohol between first alcohol self-administration day (baseline, without medication, visit 2) and the second alcohol self-administration day (after 14-19 days medication, visit 5), considering the 1st and 2nd half of the self-administration period separately."},{"outcome_type":"secondary","measure":"Differences in 1st and 2nd half of self-administration periods between max. achieved blood alcohol concentrations (BAC) for alcohol on 1st alcohol self-administration (ASA) day and 2nd ASA day.","time_frame":"18 to 31 days between 1st and 2nd measurement","description":"Outcome measure is the the difference in max. achieved blood alcohol concentrations between first alcohol self-administration day (baseline, without medication, visit 2) and the second alcohol self-administration day (after 14-19 days medication, visit 5), considering the 1st and 2nd half of the self-administration period separately."},{"outcome_type":"secondary","measure":"Differences in 1st and 2nd half of self-administration periods between cumulative CAT trials for sodium chloride on 1st alcohol self-administration (ASA) day and 2nd ASA day.","time_frame":"18 to 31 days between 1st and 2nd measurement","description":"Sodium chloride is an alternative reinforcer on alcohol self-administration.\r\nEach Sodium chloride request requires prior work according to a progressive schedule (i.e., runs of the constant attention task) to earn the next sodium chloride infusion.\r\nOutcome measure is the difference in the cumulative number of work sets for sodium chloride in the \"constant attention task\" (CAT) between first alcohol self-administration day (baseline, without medication, visit 2) and the second alcohol self-administration day (after 14-19 days medication, visit 5), considering the 1st and 2nd half of the self-administration period separately"},{"outcome_type":"secondary","measure":"Differences between subjective alcohol effects on 1st ASA day and 2nd ASA day","time_frame":"18 to 31 days between 1st and 2nd measurement","description":"alcohol-induced changes in stimulation, sedation, negative alcohol effects, craving, well-being, subjective feeling of drunkenness, subjective number of drinks and thirst measured with visual analogue scales (\"Quizzer\") before, 2 x during and after the alcohol infusion period.\r\nscale ranges: minimum = 0 to maximum = 100\r\nHigher values on a scale represent an increase of aforementioned subjective alcohol effects.\r\nComparison between 1st ASA and 2nd ASA day"},{"outcome_type":"secondary","measure":"Calcium parameters on 1st ASA and 2nd ASA day","time_frame":"18 to 31 day between 1st and 2nd measurement","description":"magnesium, phosphate, total calcium, albumin, parathormone, 25-hydroxyvitamin D measurement at baseline and difference between 2nd and 1st ASA"},{"outcome_type":"secondary","measure":"Alcohol craving (OCDS) \"Obsessive Compulsive Drinking Scale\" (OCDS)","time_frame":"18 to 31 days between 1st and 2nd measurement","description":"Craving measured with \"Obsessive Compulsive Drinking Scale\" (OCDS) before 1st and 2nd ASA The OCDS is a 14-item self-rating instrument. It provides a total and two subscale (1: obsessive, 2. compulsive) scores, that measure aspects of alcohol craving."},{"outcome_type":"secondary","measure":"Violation of imposed alcohol abstinence","time_frame":"15-20 days (abstinence period)","description":"in % of the days with alcohol consumption (measured with timeline follow-back, measured at visit 5)"},{"outcome_type":"secondary","measure":"Readiness to change","time_frame":"39 - 90 days between screening and visit 6, 6-8 weeks between visit 6 and follow-up","description":"\"Readiness to change\" questionnaire 12-item instrument for measuring the \"stage of change\" at screening, visit 6 and follow-up.\r\nThe test has three four-item subscales to allocate patients to a stage of change: pre-contemplation (P), contemplation (C) or action (A), based on the stages of change model (by Prochaska and DiClementel)\r\nAnswers are given on a scale ranging from 'strongly disagree' (\"-2\") through \"0\" to to 'strongly agree' (+2) . The range for each subscale is -8 to +8.\r\nEach subject is allocated to the stage on which it reached the highest score."},{"outcome_type":"secondary","measure":"Drinking habits","time_frame":"39 - 90 days between screening and visit 6, 32 - 55 days between visit 1 and visit 6","description":"Drinking habits measured with Timeline Follow-back Interview over 45 days before study start (measured at screening) and over the entire study duration (measured at visits 1, 3, 5, 6 and follow-up)\r\na) % drinking days, b) average amount of alcohol per drinking day, c) % of binge days (alcohol consumption over 60 g /d (men) or 48 g / d (women)), d) average amount of alcohol per binge day,"},{"outcome_type":"secondary","measure":"utilization of addiction care services","time_frame":"39 - 90 days between screening and visit 6, 32 - 55 days between visit 1 and visit 6","description":"does the subject frequent addiction care services at Screening, visit 6 and follow-up"},{"outcome_type":"secondary","measure":"Acid sphingomyelinase (ASM) activities","time_frame":"screening, 18 to 31 day between 1st and 2nd measurement, 2.5 hours from begin to end of ASA","description":"analysis in serum at screening at visits 2 and 5, before and after alcohol self-administration"},{"outcome_type":"secondary","measure":"Acamprosate blood level","time_frame":"one-time measurement after 14 - 19 days of medication intake (at visit 5)","description":"measured on 2nd ASA day (visit 5)"},{"outcome_type":"other","measure":"CIWA-Ar-Score","time_frame":"39 - 90 days between screening and visit 6, 32 - 55 days between visit 1 and visit 6","description":"Clinical Institute Withdrawal Assessment for Alcohol Scale, revised\r\nIt is a 10-item scale for clinical quantitation of the severity of the alcohol withdrawal syndrome.\r\nEach item is rated on a scale from 0 to 7, except for \"Orientation\" which is rated on scale 0 to 4.\r\nThe total CIWA-Ar score is the sum of all 10 items.\r\nmeasured at Screening, Visits 1-6."},{"outcome_type":"other","measure":"adverse events / serious adverse events","time_frame":"32 - 55 days between visit 1 and visit 6","description":"partially standardized interview about adverse events / serious adverse events\r\nmeasured at visits 1-6"}]}
{"nct_id":"NCT04399278","start_date":"2020-08-03","phase":"N/A","enrollment":40,"brief_title":"End-eXpiratory Occlusion Test to Predict fluId REsponsiveness in the Operating Room (EXPIRE)","official_title":"End-eXpiratory Occlusion Test to Predict fluId REsponsiveness in the Operating Room: Prospective Randomized Clinical Trial Comparing Two Occlusion Tests (EXPIRE)","primary_completion_date":"2021-03-24","study_type":"Interventional","rec_status":"Completed","completion_date":"2021-03-24","last_update":"2021-08-25","description":"The purpose of the study is to evaluate the influence of different durations of the end-expiratory occlusion test to predict fluid responsiveness in mechanically ventilated patients in the operating room.","other_id":"EXPIRE - RBHP 2020 FUTIER","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Diagnostic","masking_description":"Triple","intervention_model_description":"The EEO test will be performed by interrupting the mechanical ventilation at end-expiration over 15 and 30 seconds using the end-expiratory hold button available on the anesthesia ventilator. Each occlusion will be separated by 1 minute to allow a return to the baseline value.\r\nHemodynamic variables will be recorded before and immediately after each EEO procedure, and after a fluid challenge (4 ml/kg of 0.9% saline over 5 minutes).\r\nFluid responders will be defined by an increase in stroke volume 15% 1 min after the end of the fluid challenge.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adults (age >18 years)\r\n\r\n          -  Scheduled to undergo planned surgery under general anesthesia\r\n\r\n          -  Surgery requiring invasive arterial and stroke volume monitoring\r\n\r\n          -  Clinical indication to perform a fluid challenge\r\n\r\n          -  Patients able to give informed consent\r\n\r\n          -  Affiliated to a social security scheme\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patient refusal to participate or inability to provide informed consent\r\n\r\n          -  Protected major\r\n\r\n          -  History of lobectomy or pneumectomy\r\n\r\n          -  Patient with reduced left (ejection fraction < 45%) or right ventricular systolic\r\n             function\r\n\r\n          -  Arrythmia\r\n\r\n          -  Severe valvulopathy\r\n\r\n          -  Body Mass Index <15 or > 40kg/m2\r\n\r\n          -  Contraindication to insertion of invasive arterial line into radial artery\r\n\r\n          -  Emergency surgery\r\n\r\n          -  Pregnancy\r\n      ","sponsor":"University Hospital, Clermont-Ferrand","sponsor_type":"Other","conditions":"Hemodynamic Instability|General Anesthesia|Surgery|Protective Mechanical Ventilation","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Diagnostic Test: end-expiratory occlusion (EEO) test","description":"A set of respiratory and hemodynamic measurements (including cardiac output) will be recorded at each stage:\r\nT0: baseline.\r\nT1: At the end of the first EEO (15 sec or 30 sec)\r\nT2: 1 minute after completion of the first EEO. Return to baseline.\r\nT3: At the end of the second EEO (15 sec or 30 sec)\r\nT4: 1 minute after completion of the second EEO. Return to baseline.\r\nT5: Before the fluid challenge test (4 ml/kg of 0.9% saline over 5 min)\r\nT6: 1 minute after the end of the fluid challenge\r\nA first set of measurements will be performed after intubation (before the surgical incision) and will be repeated, if necessary, in case of further decrease in stroke volume during surgery or in case of any clinical indication of volume expansion (i.e., arterial persistent hypotension, major hemorrhage, etc.)."}],"outcomes":[{"outcome_type":"primary","measure":"To compare the ability of an EEO over 30 sec with that of an EEO over 15 sec to predict fluid responsiveness","time_frame":"During surgery","description":"Comparison of the areas under the ROC (Receiver Operating Characteristic) curves."}]}
{"nct_id":"NCT04067531","start_date":"2020-08-01","phase":"Phase 3","enrollment":50,"brief_title":"Treatment of BV With First Deqularum and Then Direkt After Clindamycin","official_title":"Treatment of BV With First Deqularum and Then Direkt After With Vaginal Clindamycin Cream.","primary_completion_date":"2021-08-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-12-01","last_update":"2020-10-27","description":"Treatment of BV with first deqularum cloride and then followed with clindamycin vaginal Cream.","other_id":"12","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  healthy women with BV\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  women treated with antibiotics within 1 month\r\n      ","sponsor":"Skaraborg Hospital","sponsor_type":"Other","conditions":"Infection, Bacterial","interventions":[{"intervention_type":"Drug","name":"Drug: treatment of BV with first Deqularum and then direkt after with vaginal clindamycin","description":"All patients will get the same treatment"}],"outcomes":[{"outcome_type":"primary","measure":"cure of BV","time_frame":"6 month","description":"cure rate of BV"}]}
{"nct_id":"NCT04569682","start_date":"2020-08-01","phase":"N/A","enrollment":100,"brief_title":"Outcomes of Transrenal Artery Perfusion Versus Transrenal Vein Perfusion Using LifePort for Deceased Donor Kidney Transplantation","official_title":"Outcomes of Transrenal Artery Perfusion Versus Transrenal Vein Perfusion Using LifePort for Deceased Donor Kidney Transplantation","primary_completion_date":"2021-09-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-06-30","last_update":"2021-01-25","description":"The main objective of this study is to compare the outcomes of transrenal artery perfusion versus transrenal vein perfusion using LifePort for deceased donor kidney transplantation. Patients registered in the National Dialysis and Transplant Registry awaiting deceased donor kidney transplantation were included. Delayed graft function (DGF) or primary nonfunction (PNF) may occur after deceased donor kidney transplantation. Compared with static cold storage, the application of LifePort can significantly reduce the incidence of DGF and PNF in deceased donor kidney transplantation. Transrenal artery perfusion is currently the mainstream but confronts multiple renal arteries, resulted in prolonged cold ischemia time. Transrenal vein perfusion is expected to be a solution. However, whether the clinical outcomes of transrenal vein perfusion is inferior to transrenal artery perfusion remains unknown. In this study, values of urine volume and creatinine, incidence and duration of DGF, and incidence of PNF within 1 week after surgery are recorded and compared between the transrenal artery perfusion group and the transrenal vein perfusion group. Monthly eGFR and creatinine values, the incidence of acute rejection within 1 year after transplantation and 1-year graft and patient survival are also recorded and compared.","other_id":"WestChina-LifePort","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Adult recipients older than 18 years;\r\n\r\n          2. Patients diagnosed with end-stage renal diseases and volunteered to register in the\r\n             Transplant and Dialysis Registry of China awaiting for deceased donor kidney\r\n             transplantation;\r\n\r\n          3. First single kidney transplantation;\r\n\r\n          4. The recipients can understand the purpose and risk of deceased kidney transplantation\r\n             and sign informed consent;\r\n\r\n          5. Ethics committee approved.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients less than 18 years old, or more than 65 years old;\r\n\r\n          2. Patients who receive multiple organ transplants;\r\n\r\n          3. Diagnosed with malignancy or had a history of malignancy in the past 5 years;\r\n\r\n          4. non-kidney transplantation history.\r\n      ","sponsor":"West China Hospital","sponsor_type":"Other","conditions":"Kidney Transplantation|Organ Preservation","interventions":[{"intervention_type":"Device","name":"Device: LifePort transrenal artery perfusion","description":"transrenal artery perfusion group"},{"intervention_type":"Device","name":"Device: LifePort transrenal vein perfusion","description":"transrenal vein perfusion group"}],"outcomes":[{"outcome_type":"primary","measure":"Delayed graft function","time_frame":"Within one week posttransplantation","description":"Delayed graft function is defined as the need for dialysis (for any cause) within the first week posttransplantation."},{"outcome_type":"secondary","measure":"Graft loss","time_frame":"One year after transplantation","description":"Graft loss was defined as re-establishment of long-term dialysis or estimated glomerular filtration rate (eGFR) of <15 ml/min."},{"outcome_type":"secondary","measure":"biopsy-confirmed acute rejection","time_frame":"One year after transplantation","description":"biopsy-confirmed acute rejection was diagnosed clinically based on a significant increase in serum creatinine levels of 50% or more within 3 days, which was not explained by other reasons and confirmed by biopsy."}]}
{"nct_id":"NCT04337554","start_date":"2020-08-01","enrollment":75,"brief_title":"Exoskeleton Footwear to Improve Walking","official_title":"Exoskeleton Footwear to Improve Walking Performance and Subject-reported Preference","primary_completion_date":"2024-03-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2024-03-31","last_update":"2021-01-28","description":"The purpose of this study is to determine the best assistance level of an exoskeleton footwear (EF) that can assist walking for people older than 40 with and without peripheral artery disease (PAD). The test will be performed on two different groups of people for this study that include: 1) people with PAD, and 2) individuals who don't have PAD. Data will be collected from 50 healthy older individuals and 25 patients with PAD, both groups will be 40 years or older. Gait biomechanics, muscle oxygenation, and energy cost for seven different walking conditions including normal walking, walking with EF with no assistance, and walking with EF with 5 different levels of assistance will be collected from the healthy older individuals. Additionally, subject-reported outcomes after each walking conditions including perceived comfort and fatigue, rate of perceived exertion and feasibility of the EF will be collected. Gait biomechanics, muscle oxygenation, energy cost, and patient-reported outcomes will be measured in patients with PAD for four walking conditions including normal walking, walking with EF but no assistance, walking with EF with the best two assistance levels. Subjects will be allowed to acclimate to the EF prior to recording data. All patients with PAD will participate in feasibility interviews that will assess acceptability, demand, implementation, and practicality. All subjects will be asked to fill out questionnaires that assess quality of life, physical function, and the ability to complete activities of daily living.","other_id":"A3266-R","observational_model":"Other","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":40,"population":"Omaha VA Medical Center","criteria":"\n        Inclusion Criteria:\r\n\r\n        Inclusion criteria for healthy older: At entry into the study, all subjects must:\r\n\r\n          -  Be able to give written, informed consent\r\n\r\n          -  Have a stable blood pressure regimen, stable lipid regimen, stable diabetes regimen\r\n             and risk factor control for 6 weeks as determined by a health history questionnaire\r\n\r\n          -  Be 40 years of age or older\r\n\r\n               -  Healthy aged selected to match the population of patients with PAD\r\n\r\n          -  Demonstrate negative history of chronic claudication or other exercise limitation as\r\n             determined by a health history questionnaire\r\n\r\n        Inclusion criteria for patients with PAD: At entry into the study, all subjects must:\r\n\r\n          -  Meet criteria 1-3 from above\r\n\r\n          -  Demonstrate positive history of chronic claudication pain\r\n\r\n          -  Demonstrate exercise-limiting claudication per history and direct observation\r\n\r\n          -  Have evidence of occlusive disease on ankle/brachial index testing and/or computerized\r\n             tomographic angiography\r\n\r\n        Exclusion Criteria:\r\n\r\n        Exclusion criteria for healthy older, any potential subjects will be excluded if they have:\r\n\r\n          -  An ankle-brachial index < 0.90 at rest, as measured by the study team\r\n\r\n               -  Healthy subjects only\r\n\r\n          -  Individuals without symptoms but with reduce blood flow (asymptomatic PAD) will be\r\n             excluded\r\n\r\n          -  Walking capacity limited by conditions affecting the legs (joint/musculoskeletal,\r\n             neurologic) and systemic (heart, lung disease) pathology\r\n      ","sponsor":"VA Office of Research and Development","sponsor_type":"U.S. Fed","conditions":"Peripheral Arterial Disease","interventions":[{"intervention_type":"Device","name":"Device: Exoskeleton footwear","description":"Assistive footwear"}],"outcomes":[{"outcome_type":"primary","measure":"biological ankle torque in Newton meters/kilogram","time_frame":"baseline assessment","description":"The primary outcome variables of biological contribution to ankle torque and power will be calculated from five steps per leg during the flat ground walking. Ground reaction forces for the vertical, anterior-posterior, and medial-lateral direction, and joint angles, joint angular velocity for the hip, knee, and ankle during the stance phase of walking, joint torques and powers are will also be calculated."},{"outcome_type":"secondary","measure":"Muscle Oxygenation","time_frame":"baseline assessment","description":"Resting StO2, minimum StO2 during each treadmill trial, time to minimum StO2, and the StO2 recovery time will be calculated."},{"outcome_type":"secondary","measure":"Energy cost","time_frame":"baseline assessment","description":"Steady-state oxygen consumption in ml/kg/min will be calculated from the final three minutes of the treadmill walking test."},{"outcome_type":"secondary","measure":"Rate of perceived exertion","time_frame":"baseline assessment","description":"Self-reported perceived exertion values from the Borg Rate of Perceived Exertion scale (6 (no exertion) to 20 (maximal exertion)) will be recorded after each condition."},{"outcome_type":"secondary","measure":"Claudication Onset and Peak Walking Times (seconds)","time_frame":"baseline assessment","description":"Subjects will perform a progressive-load treadmill test. During the treadmill test, patients will walk on a treadmill that starts at 0% grade and 2.0 miles/hour. Every two minutes, the grade will be increased by 2% up to a maximum of 15% grade and the speed will be held constant. Subjects will report claudication pain during the test. The initial distance walked prior to the onset of pain (Claudication Onset Time - COT) and the distance patients walked until the test had to be stopped due to pain (Peak Walking Time -PWT) will be the outcome measures."}]}
{"nct_id":"NCT04607928","start_date":"2020-08-01","phase":"Phase 2","enrollment":148,"brief_title":"Pirfenidone Compared to Placebo in Post-COVID19 Pulmonary Fibrosis COVID-19","official_title":"Phase-II Randomized Clinical Trial to Evaluate the Effect of Pirfenidone Compared to Placebo in Post-COVID19 Pulmonary Fibrosis","primary_completion_date":"2021-08-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-08-01","last_update":"2020-11-05","description":"Study population: Patients with fibrotic lung sequelae after recovery from acute phase of severe COVID19 pneumonia Objectives: To evaluate the effect of pirfenidone administered for 24 weeks in patients who have pulmonary fibrotic changes after suffering severe COVID19 pneumonia, analysed by - % change in forced vital capacity (FVC) - % fibrosis in high resolution computed tomography (HRCT) of the lung","other_id":"2020-002518-42","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Triple","intervention_model_description":"2:1 (treatment:placebo)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age > 18 years\r\n\r\n          -  Signed Informed Consent Form\r\n\r\n          -  Ability to comply with the study protocol in the opinion of the Investigator\r\n\r\n          -  Confirmation of SARS-COV2 infection in previous weeks (Confirmation of negativity or\r\n             no activity of SARS-COV2 before randomization using the usual tests performed in the\r\n             hospital), which induced severe pneumonia and ARDS, with subsequent torpid recovery\r\n             and/or incipient clinical-radiological signs of pulmonary fibrosis.\r\n\r\n          -  HRCT with fibrotic radiological changes of at least 5% after recovery from the acute\r\n             process (HRCT chest during the screening period, performed minimum after 1 month of\r\n             the acute phase and maximum 90 days after hospital discharge)\r\n\r\n          -  Be able to understand the information given and sign the informed consent\r\n\r\n          -  For women or men of childbearing age who are not sterile, a commitment to use\r\n             non-hormonal contraception during the 24-week treatment period will be required.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Use of systemic steroids (oral or intravenous) at doses greater than 15 mg/day one\r\n             month prior to randomisation.\r\n\r\n          -  Severe or moderate myopathy that may associate a decrease of FVC.\r\n\r\n          -  Severe or life-limiting chronic disease prior to COVID19 infection, including severe\r\n             asthma, cancer, clinical dementia, IPF, or uncontrolled ischemic cardiomyopathy.\r\n\r\n          -  Treatment with pirfenidone or nintedanib prior to Covid19\r\n\r\n          -  Concomitant treatment with significant interactions with pirfenidone (such as\r\n             fluvoxamine).\r\n\r\n          -  Participation in any other investigational trial throughout the study\r\n\r\n          -  Active smoking.\r\n\r\n          -  Relevant blood alterations in the analysis made during the screening period:\r\n\r\n               -  Total bilirubin > 2 ULN\r\n\r\n               -  AST/SGOT or ALT/SGPT > 2.5 ULN\r\n\r\n               -  Alkaline phosphatase >3.0 ULN\r\n\r\n               -  Creatinine Clearance <40 mL/min, calculated by the Cockcroft-Gault formula\r\n\r\n          -  Pregnancy or lactation\r\n\r\n          -  Concomitant treatments that can cause severe digestive problems.\r\n\r\n          -  Gastric surgery in the last 3 months or similar procedures that may increase gastric\r\n             intolerance.\r\n\r\n          -  Inability to complete required visits.\r\n\r\n          -  Previous intolerance or allergy to pirfenidone or hypersensitivity to any of its\r\n             excipients.\r\n\r\n          -  History of angioedema\r\n      ","sponsor":"Institut d'Investigaci Biomdica de Bellvitge","sponsor_type":"Other","conditions":"Fibrotic Pulmonary Sequelae Post-COVID19 Infection","interventions":[{"intervention_type":"Drug","name":"Drug: Pirfenidone","description":"Comparing the effect of pirfenidone in avoiding establishing or progression of fibrosis induced after COVID19 infection"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Comparing the effect of pirfenidone in avoiding establishing or progression of fibrosis induced after COVID19 infection"}],"outcomes":[{"outcome_type":"primary","measure":"To investigate the effect of pirfenidone on fibrotic signs induced by COVID19 infection","time_frame":"24 weeks","description":"To investigate the effect of pirfenidone administered for 24 weeks measuring the number of patients who have pulmonary fibrotic changes from baseline after suffering severe COVID19 pneumonia, analysed by\r\nChange From Baseline in % in forced vital capacity (FVC)\r\nChange From Baseline % fibrosis in high resolution computed tomography (HRCT) of the lung"},{"outcome_type":"secondary","measure":"Maintenance of stability or functional improvement FVC","time_frame":"24 weeks","description":"Number of patients who show maintenance of stability or functional improvement: stability will be considered when the FVC does not increase more than 10% or does not decrease more than 10% and the DLCO does not increase more than 15% or decreases more than 15%. An increase in% FVC greater than 10% or in DLCO greater than 15% will be considered significant improvement."},{"outcome_type":"secondary","measure":"Decreased oxygen requirement for physical activity","time_frame":"24 weeks","description":"Rate of decreased oxygen requirement for physical activity in patients"},{"outcome_type":"secondary","measure":"Improved exercise capacity (> 50 meter improvement or less decrease in% oxygen saturation) in the TM6m","time_frame":"24 weeks","description":"Number of patients who have improved exercise capacity (> 50 meter improvement or less decrease in% oxygen saturation) in the TM6m"},{"outcome_type":"secondary","measure":"Hospitalizations (general and due to respiratory problems)","time_frame":"24 weeks","description":"Number of Hospitalizations (general and due to respiratory problems)"},{"outcome_type":"secondary","measure":"Visits to the Emergency or Day Hospital for respiratory causes","time_frame":"24 weeks","description":"Number of Visits to the Emergency or Day Hospital for respiratory causes"},{"outcome_type":"secondary","measure":"Lung transplantation","time_frame":"24 weeks","description":"Number of patients who need Lung transplantation"},{"outcome_type":"secondary","measure":"Death","time_frame":"24 weeks","description":"Number of patients who die"}]}
{"nct_id":"NCT02171351","start_date":"2020-08-01","phase":"N/A","enrollment":10,"brief_title":"Effect of Neuromuscular Electrostimulation on Sympathetic Nerve Activity in Patients With Type 2 Diabetes (ELECTROSYMP2)","official_title":"Effect of Neuromuscular Electrostimulation on Sympathetic Nerve Activity in Patients With Type 2 Diabetes (ELECTROSYMP2)","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-06-30","last_update":"2020-09-07","description":"Physical activity (PA) is recommended for the treatment of subjects with type 2 diabetes to increase insulin sensitivity and improve metabolic control. However, adherence to PA is often poor, due to a lack of motivation or due to disabling complications or comorbidities. Neuromuscular electrostimulation (NMES) is a physical treatment commonly used to improve muscle strength and volume in several situations: after stroke, after limb trauma or during chest rehabilitation in deconditioned patients. The investigators have already shown in a first pilot study (manuscript in preparation) that NMES improves insulin sensitivity : in the study ELECTRODIAB (No. ID-RCB: 2011-A00930-41), the investigators showed a 25% insulin sensitivity improvement after a week of daily 25-min bi-quadricipital NMES session, in a population of patients with orally-treated type 2 diabetes. Insulin sensitivity increased up to 50% in the most deconditioned subjects. Discrepancy between this result and the very low energy expenditure measured during sessions suggests that the metabolic effect was not solely mediated by muscle contractions. The investigators hypothesize the involvement of neurological pathways. Indeed, it is demonstrated that the autonomic nervous system is an important regulator of glucose metabolism with pancreatic action, a key role in energy metabolism and a complex relationship with insulin resistance. Muscle activity, whether static (isometric) or dynamic causes changes in sympathetic nerve activity in healthy subjects but its effect in type 2 diabetic subjects is not known. The investigators hypothesize that, in type 2 diabetic subjects, the modulation of sympathetic nerve activity by NMES could be involved in the improvement of insulin sensitivity. To address this question, the investigators propose to assess sympathetic nerve activity with the gold standard method of microneurography before and after a single bi-quadricipital NMES session. The impact of neuro-electro-stimulation (NES) (a sensitive stimulation under muscular threshold) and the impact of voluntary isometric muscle contractions (VC) will also be evaluated. These procedures will also be applied in healthy control subjects.","other_id":"2014-A00559-38","allocation":"Non-Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  type 2 diabetes for at least 12 month\r\n\r\n          -  treatment by oral hypoglycemic agents and/or GLP1 agonists\r\n\r\n          -  HbA1c : 6-10%\r\n\r\n          -  suspected insulin-resistance (at least one criteria below) :\r\n\r\n          -  waist circumference > 80cm (female); > 94cm (male)\r\n\r\n          -  triglycerides > 150 mg/dl\r\n\r\n          -  HDL-cholesterol < 50 mg/dl (female); < 40 mg/dl (male)\r\n\r\n          -  low background physical activity (Ricci-Gagnon score < 27)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  type 1 diabetes\r\n\r\n          -  treatment with insulin\r\n\r\n          -  seizure\r\n\r\n          -  pace maker\r\n      ","sponsor":"University Hospital, Caen","sponsor_type":"Other","conditions":"Type 2 Diabetes|Insulin Resistance","interventions":[{"intervention_type":"Device","name":"Device: effect of neuromuscular electrostimulation (NMES)","description":"Each subject (type 2 diabetes and control) will be assessed with plethysmography during a single session of neuromuscular electrostimulation (NMES)."},{"intervention_type":"Device","name":"Device: effect of neuro electrostimulation (NES)","description":"Each subject (type 2 diabetes and control) will be assessed with plethysmography during a single session of neuro electrostimulation (NES)"},{"intervention_type":"Other","name":"Other: effect of voluntary contractions (VC)","description":"Each subject (type 2 diabetes and control) will be assessed with plethysmography during a single session of voluntary contractions (VC)"}],"outcomes":[{"outcome_type":"primary","measure":"Sympathetic nerve reactivity in response to a single session of neuromuscular electrostimulation","time_frame":"at 0, 5, 10, 15, 20 min of the NMES session","description":"Sympathetic nerve reactivity will be assessed by plethysmography, with a Valsalva procedure, at baseline and every 5 minutes during a 20-min session of biquadricipital neuromuscular electrostimulation"},{"outcome_type":"secondary","measure":"sympathetic nerve reactivity in response to a single session of neuro electrostimulation","time_frame":"at 0, 5, 10, 15, 20 min of the NES session","description":"Sympathetic nerve reactivity will be assessed by plethysmography, with a Valsalva procedure, at baseline and every 5 minutes during a 20-min session of biquadricipital neuro electrostimulation"},{"outcome_type":"secondary","measure":"sympathetic nerve reactivity in response to a single session of voluntary muscular contractions","time_frame":"at 0, 5, 10, 15, 20 min of the VC session","description":"Sympathetic nerve reactivity will be assessed by plethysmography, with a Valsalva procedure, at baseline and every 5 minutes during a 20-min session of biquadricipital voluntary contractions"},{"outcome_type":"other","measure":"comparison of sympathetic nerve reactivity between the different groups and procedures","time_frame":"at 0, 5, 10, 15, 20 min of each session","description":"sympathetic nerve reactivity will be compared between type 2 diabetic and healthy subjects and between neuromuscular electrostimulation, neuro electrostimulation and voluntary contractions"}]}
{"nct_id":"NCT04660292","start_date":"2020-08-01","phase":"N/A","enrollment":30,"brief_title":"Clinical Outcomes of Maitland's Mobilization in Patients With Myofacial Chronic Neck Pain","official_title":"Clinical Outcomes of Maitland's Mobilization in Patients With Myofacial Chronic Neck Pain","primary_completion_date":"2020-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-10-30","last_update":"2020-12-09","description":"Myofacial neck pain is a common musculoskeletal problem caused by presence of trigger points and local and referred pain patterns. Chronic neck pain is responsible for the involvement of joints, ligaments, fascia and connective tissue as well. The objective of this study was to assess the impacts of Maitland's mobilization in patients with myofacial chronic neck pain. Maitland's mobilization is one of the most common manual therapy approaches used by physiotherapists. Maitland's techniques involve the application of passive and accessory oscillatory movements to spinal and vertebral joints to treat pain and stiffness. In this randomized, placebo treatment controlled trial, 30 patients consecutively aged 25-45 years meeting inclusion criteria were isolated into two groups. The study group was treated with Maitland's mobilization consistently for 8 weeks while the control group got placebo treatment for a similar time frame. Visual analog Scale (VAS), Neck disability index (NDI) and cervical range of motion (ROM) questionnaire was filled by patients before, intermediate and after the intervention to evaluate the severity of pain, functional ability and range of motion.","other_id":"PT-Associate-MARYAM SHABBIR","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":25,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients age between 25-45 years old,\r\n\r\n          -  Bilateral pain involving the upper trapezius and elevator muscle of the scapula;\r\n\r\n          -  Duration of pain of at least 3 months;\r\n\r\n          -  A pain intensity corresponding to at least 2 cm on a 10 cm visual analogue scale\r\n             (VAS); -Neck pain with symptoms provoked by either neck postures or neck movement;\r\n\r\n          -  Pain localized at least in the cervical and occipital regions but not in the orofacial\r\n             region; --Neck disability index (NDI) greater than or equal to 15 points;\r\n\r\n          -  Restricted cervical range of movements (flexion, extension, rotation, and\r\n             side-bending); ---Presence of bilateral MTrPs in upper trapezius and levator scapulae\r\n             muscles were included in this study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  A history of traumatic injuries (e.g., contusion, fracture, and whiplash injury);\r\n\r\n          -  Systemic diseases such as fibromyalgia, systemic erythematous lupus and arthritis;\r\n\r\n          -  Neurologic disorders (e.g., trigeminal neuralgia or occipital neuralgia);\r\n\r\n          -  Concomitant medical diagnosis of any primary headache (tension type or migraine);\r\n\r\n          -  Cervical spine surgery; and clinical diagnosis of cervical radiculopathy or myelopathy\r\n      ","sponsor":"Riphah International University","sponsor_type":"Other","conditions":"Myofascial Pain Syndrome of Neck","interventions":[{"intervention_type":"Other","name":"Other: Maitland's mobilization","description":"Maitland's techniques involve the application of passive and accessory oscillatory movements to spinal and vertebral joints to treat pain and stiffness.It has Five grades"},{"intervention_type":"Other","name":"Other: Traditional Physical therapy","description":"BASELINE TREATMENT INCLUDES TENS and Hot PACKS"}],"outcomes":[{"outcome_type":"primary","measure":"Visual Analogue Scale","time_frame":"2 months","description":"Its a pain rating Scale Scoring between 0-10.O means no pain 10 means worse pain"},{"outcome_type":"primary","measure":"Neck disability Index","time_frame":"2 months","description":"Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'."}]}
{"nct_id":"NCT04255953","start_date":"2020-08-01","phase":"N/A","enrollment":70,"brief_title":"Development of a Telehealth Obesity Intervention for Patients With MS: Modifying Diet and Exercise in MS","official_title":"Development of a Telehealth Obesity Intervention for Patients With MS: Modifying Diet and Exercise in MS","primary_completion_date":"2024-10-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2024-10-31","last_update":"2020-08-06","description":"We will tailor a telehealth obesity intervention for obese patients with MS (figure 2). Half of the patients will be randomly assigned to 24 weekly hour-long group weight loss sessions and 6 monthly individual sessions; half will be assigned to a brief education/Treatment as Usual (TAU) control condition. Participants assigned to the control condition will also receive the active treatment 6 months following their enrollment. As such, we will have feasibility, acceptability, and outcome data for all patients who enroll and complete the intervention. During outpatient recruitment, clinicians will ask obese patients (WHtR >.57, BMI >29) if they would be willing to be contacted about a study investigating a weight loss intervention for patients with MS. Patients who express interest and respond to advertisements will be screened by telephone and via review of medical records. Patients who meet initial eligibility criteria will be invited for a baseline evaluation where they will be formally consented, complete questionnaires and behavioral tasks, and undergo a standardized physical exam. They will be monitored using actigraphy for 10 days. They will then be randomized to the group telehealth obesity intervention or TAU. At 6 months, all participants will undergo a second in-person follow-up assessment and TAU participants will begin the telehealth intervention. At 12 months, participants will undergo a third in-person assessment, providing treatment outcome data for all study participants and long-term weight maintenance data for patients initially assigned to the telehealth obesity intervention. At 18 months, participants initially assigned to the TAU control condition will undergo a 4th assessment, providing weight maintenance data for all enrolled participants.","other_id":"IRB 2016418","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        (a) a diagnosis of relapsing-remitting, secondary progressive, or primary progressive MS\r\n        based on established guidelines and verified by medical chart review (b) between the ages\r\n        of 18-70 (c) access to a telephone (d) English-speaking (e) ability to walk 25 feet without\r\n        assistance and no severe sensory or motor impairment that would limit participation or\r\n        present serious medical risks (f) no medically confirmed relapse in the past month (g) no\r\n        history of dementia or severe cognitive difficulties that would limit participation (h)\r\n        WHtR >.57 or BMI >29 (i) no history of bariatric surgery (j) no history of food allergies\r\n        or need for a special diet preventing consumption of the recommended diet (k) no concurrent\r\n        ongoing behavioral or pharmacological weight loss interventions (l) no history of insulin\r\n        dependent diabetes or serious pulmonary/cardiac conditions (m) weight stability with no\r\n        history of >10 pounds weight loss or gain in the 3 months prior to study participation (n)\r\n        no planned or recent joint replacement surgeries (o) no serious psychiatric disorder (e.g.\r\n        schizophrenia), current suicidal ideation, or current binge eating disorder as these\r\n        patients may not be good candidates for behavioral weight loss programs (p) no current\r\n        medical conditions where weight loss is contraindicated, as indicated by the participant's\r\n        primary care physician (q) no contraindications to exercise (answer \"no\" to all 7 questions\r\n        on Physical Activity Readiness Questionnaire; PAR-Q114) or physician approval to exercise\r\n        if answer \"yes\" to 1 or more questions on PAR-Q. -\r\n      ","sponsor":"Jared Bruce","sponsor_type":"Other","conditions":"Multiple Sclerosis|Obesity","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: behavioral telehealth","description":"Participants will receive 24 weekly group phone counseling sessions. Each session will last approximately 60 minutes and begin with an open-ended check-in question, followed by review of weekly self-monitoring data, question and answer time, and end with a new didactic topic of the week addressing diet, physical activity, or behavior change topics. Participants will be instructed to follow a diet that is reduced to 1200-1500 kcal/day and includes  5 fruit and vegetable (FV) servings per day, <25% kcal from fat, and 20-30 g of fiber. Physical activity will be gradually increased through a guided home-based program. Throughout the intervention, self-monitoring will be emphasized as a key behavioral weight loss strategy."},{"intervention_type":"Other","name":"Other: Treatment as Usual","description":"Treatment as Usual"}],"outcomes":[{"outcome_type":"primary","measure":"Weight Loss","time_frame":"6 months","description":"percent weight change"},{"outcome_type":"secondary","measure":"modified fatigue Impact scale","time_frame":"6 months","description":"self-reported fatigue"},{"outcome_type":"secondary","measure":"Hospital Anxiety and Depression Scale","time_frame":"6 months","description":"self-reported depression"},{"outcome_type":"secondary","measure":"MS Quality of Life Inventory","time_frame":"6 months","description":"Self-report measure of quality of life"},{"outcome_type":"secondary","measure":"6 Minute Walk","time_frame":"6 months","description":"Mobility Assessment"},{"outcome_type":"other","measure":"Actigraphy","time_frame":"6 Months","description":"Change in Activity pre/post treatment"},{"outcome_type":"other","measure":"DXA","time_frame":"6 Months","description":"Body composition/Percent body fat"}]}
{"nct_id":"NCT04495101","start_date":"2020-07-29","phase":"Phase 2","enrollment":100,"brief_title":"Study to Evaluate the Safety and Efficacy of Prolastin in Hospitalized Subjects With COVID-19","official_title":"A Multicenter, Randomized, Open-label, Parallel Group Pilot Study to Evaluate the Safety and Efficacy of Prolastin Plus Standard Medical Treatment (SMT) Versus SMT Alone in Hospitalized Subjects With COVID-19","primary_completion_date":"2021-04-26","study_type":"Interventional","rec_status":"Completed","completion_date":"2021-06-10","last_update":"2021-07-08","description":"The primary objective of the study is to determine if Prolastin plus SMT can reduce the proportion of subjects dying or requiring intensive care unit (ICU) admission on or before Day 15 or who are dependent on invasive mechanical ventilation on Day 15 versus SMT alone in hospitalized subjects with Coronavirus disease 2019 (COVID-19).","other_id":"GC2005","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Hospitalized male or female subject  18 years of age at the time of Screening who is\r\n             being treated for COVID-19. Subjects must be screened within 48 hours ( 48 hours) of\r\n             hospital admission.\r\n\r\n          2. Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by\r\n             qualitative Polymerase Chain Reaction (PCR) (reverse transcriptase [RT]-PCR) or other\r\n             commercial or public health assay in any specimen during the current hospital\r\n             admission prior to randomization.\r\n\r\n          3. COVID-19 illness (symptoms) of any duration, including both of the following:\r\n\r\n               1. Radiographic infiltrates by imaging (chest X-Ray, computerized tomography (CT)\r\n                  scan, etc.) and/or clinical assessment (evidence of rales/crackles on the exam)\r\n                  with peripheral oxygen saturation by pulse oximetry (SpO2) <94% on room air\r\n\r\n               2. Any One of the following related to COVID-19: i. Ferritin > 400 nanogram per\r\n                  milliliter (ng/mL), ii. Lactate dehydrogenase (LDH) > 300 units per liter (U/L),\r\n                  iii. D-Dimers > reference range, or iv. C-reactive protein (CRP) > 40 milligram\r\n                  per liter (mg/L)\r\n\r\n          4. Subjects provides informed consent prior to the initiation of any study procedures.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Subjects requiring invasive mechanical ventilation or ICU admission or with PaO2/FIO2\r\n              150 mm Hg (ie, arterial oxygen in mm Hg divided by fraction inspired oxygen\r\n             concentration [eg, 0.21 for room air]).\r\n\r\n          2. Clinical evidence of any significant acute or chronic disease that, in the opinion of\r\n             the investigator, may place the subject at undue medical risk.\r\n\r\n          3. The subjects have had a known serious anaphylactic reaction to blood, any\r\n             blood-derived or plasma product, or known selective immunoglobulin A (IgA) deficiency\r\n             with anti-IgA antibodies.\r\n\r\n          4. A medical condition in which the infusion of additional fluid is contraindicated.\r\n\r\n          5. Shock that is unresponsive to fluid challenge and/or multiple vasopressors and\r\n             accompanied by multiorgan failure considered not able to be reversed by the Principal\r\n             Investigator.\r\n\r\n          6. Known alpha-1 antitrypsin deficiency for which the subject is already receiving\r\n             alpha1-proteinase inhibitor augmentation therapy.\r\n\r\n          7. Women who are pregnant or breastfeeding. Female subjects of child-bearing potential\r\n             must have a negative test for pregnancy blood or urine human chorionic gonadotropin\r\n             (HCG)-based assay at Screening/Baseline Visit.\r\n\r\n          8. Subjects for whom there is limitation of therapeutic effort such as \"Do not\r\n             resuscitate\" status.\r\n\r\n          9. Currently participating in another interventional clinical trial with investigational\r\n             medical product or device.\r\n\r\n         10. Subjects previously requiring long-term oxygen therapy (home oxygen therapy).\r\n      ","sponsor":"Instituto Grifols, S.A.","sponsor_type":"Industry","conditions":"COVID-19","interventions":[{"intervention_type":"Biological","name":"Biological: Prolastin","description":"Intravenous infusion 120 mg/kg"},{"intervention_type":"Drug","name":"Drug: Standard Medical Treatment","description":"Standard medical treatment per local policies or guidelines"}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of Subjects Dying or Requiring ICU Admission","time_frame":"Up to Day 15"},{"outcome_type":"primary","measure":"Percentage of Subjects Who are Dependent on Invasive Mechanical Ventilation","time_frame":"Day 15"},{"outcome_type":"secondary","measure":"Change from Baseline in National Early Warning Score (NEWS)","time_frame":"Day 1 through Day 29"},{"outcome_type":"secondary","measure":"Time to Clinical Response as Assessed by: NEWS ≤ 2 Maintained for 24 hours","time_frame":"Day 1 through Day 29"},{"outcome_type":"secondary","measure":"Time to Hospital Discharge","time_frame":"Day 1 through Day 29"},{"outcome_type":"secondary","measure":"Duration of ICU Stay","time_frame":"Up to Day 29"},{"outcome_type":"secondary","measure":"Duration of Any Oxygen Use","time_frame":"Day 1 through Day 29"},{"outcome_type":"secondary","measure":"Duration of Mechanical Ventilation","time_frame":"Up to Day 29"},{"outcome_type":"secondary","measure":"Mean Change from Baseline in Ordinal Scale","time_frame":"Day 1 through Day 29"},{"outcome_type":"secondary","measure":"Absolute Value Change from Baseline in Ordinal Scale","time_frame":"Day 1 through Day 29"},{"outcome_type":"secondary","measure":"Percentage of Subjects in Each Severity Category of the 7-Point Ordinal Scale","time_frame":"Day 15, Day 29"},{"outcome_type":"secondary","measure":"Time to Sustained Normalization of Temperature","time_frame":"Day 1 through Day 29"},{"outcome_type":"secondary","measure":"Percentage of Subjects who Sustained Normalization of Temperature","time_frame":"Day 1 through Day 29"},{"outcome_type":"secondary","measure":"Number of Subjects who Develop Acute Respiratory Distress Syndrome (ARDS)","time_frame":"Up to Day 29"},{"outcome_type":"secondary","measure":"Length of Time to Clinical Progression","time_frame":"Up to Day 29"},{"outcome_type":"secondary","measure":"Mortality Through Day 29","time_frame":"Up to Day 29"}]}
{"nct_id":"NCT04318704","start_date":"2020-07-29","phase":"Phase 2","enrollment":20,"brief_title":"Efficacy, Safety and Tolerability of NP-120 on Idiopathic Pulmonary Fibrosis and Its Associated Cough","official_title":"An Open Label Study of the Efficacy, Safety and Tolerability of NP-120 on Idiopathic Pulmonary Fibrosis and Its Associated Cough","primary_completion_date":"2021-08-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-09-30","last_update":"2021-04-14","description":"NP-120 (Ifenprodil) has been shown to mediate anti-inflammatory responses and reduce pulmonary fibrosis in a murine model of Idiopathic Pulmonary Fibrosis (IPF). In addition, NP-120 significantly reduced both cough frequency and onset in a guinea pig tussive model. The purpose of this proof-of-concept trial is to determine the efficacy of NP-120 in the treatment of IPF and its associated cough.","other_id":"AGN120-1","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Male and female subjects with a diagnosis of IPF established during the previous seven\r\n             years according to ATS/ERS/Fleischner criteria.\r\n\r\n          2. Score  40 mm on the Cough Severity VAS at Screening\r\n\r\n          3. Lung function parameters as follows:\r\n\r\n               1. Forced Vital Capacity (FVC)  45% of the predicted value at screening.\r\n\r\n               2. Diffusion lung capacity for carbon monoxide (DLCO) (corrected for Hb) of 30% to\r\n                  79% of the predicted value at screening.\r\n\r\n          4. Any existing Standard of Care (SoC) treatment (e.g. pirfenidone or nintedanib) must be\r\n             deemed as stable (minimum three months) before enrollment.\r\n\r\n          5. Subjects must sign and date a written, informed consent form and any required\r\n             authorization prior to initiation of any study procedures.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Currently has significant airways obstruction: Forced Expiratory Volume in 1 s\r\n             (FEV1)/Forced Vital Capacity (FVC) ratio of < 0.7 at screening.\r\n\r\n          2. Has clinical evidence of active infection, including, but not limited to, bronchitis,\r\n             pneumonia, sinusitis, urinary tract infection, and cellulitis.\r\n\r\n          3. Has a history of malignancy within the last 2 years with the exception of basal cell\r\n             carcinoma, chronic lymphocytic leukaemia (under observation) and prostate cancer\r\n             requiring anti-androgens, localised treatment (minor surgery, radiotherapy) and/or\r\n             managed by observation, and squamous cell carcinoma if diagnosed and successfully\r\n             treated more than 6 months prior to the study. SCC diagnosed with the past 6 months\r\n             will be exclusionary.\r\n\r\n          4. Patients experiencing cerebral hemorrhage or cerebral infarction at\r\n             screening/baseline.\r\n\r\n          5. Has any condition other than IPF that, in the opinion of the investigator, is likely\r\n             to result in the death of the subject within the next 2 years.\r\n\r\n          6. Presence of other disease that may interfere with testing procedures or in the\r\n             judgement of the Investigator may interfere with trial participation or may put the\r\n             patient at risk when participating in this trial.\r\n\r\n          7. Is likely to receive lung transplantation within the next 12 months.\r\n\r\n          8. Currently receiving high dose corticosteroid, cytotoxic (e.g., chlorambucil,\r\n             azathioprine, cyclophosphamide, methotrexate), vasodilator therapy for pulmonary\r\n             hypertension (e.g., bosentan), and or investigational therapy for idiopathic pulmonary\r\n             fibrosis (IPF) or administration of such therapeutics within 4 weeks of initial\r\n             screening (or 5 half-lives, whichever is longer). A current dose of less than or equal\r\n             to 15 mg/day of prednisone or its equivalent is acceptable if the dose is anticipated\r\n             to remain stable during the study.\r\n\r\n          9. Has a history of unstable or deteriorating cardiac or pulmonary disease (other than\r\n             IPF) within the previous six months, including, but not limited to, the following:\r\n\r\n               1. Unstable angina pectoris or myocardial infarction, or percutaneous coronary\r\n                  intervention within the last 6 months,\r\n\r\n               2. Congestive heart failure requiring hospitalization,\r\n\r\n               3. Uncontrolled clinically significant arrhythmias.\r\n\r\n         10. If female, the subject is pregnant or lactating or intending to become pregnant before\r\n             participating in this study during the study and within (5 half- lives plus 30 days)\r\n             after last dose of the study drug; or intending to donate ova during such time period.\r\n\r\n         11. Women considered to be of childbearing potential who do not use highly effective birth\r\n             control methods during the study.\r\n\r\n         12. Known or suspected allergy to the trial drug or the relevant drugs given in the trial.\r\n\r\n         13. Involvement in a clinical research study within 4 weeks prior to screening and/or\r\n             prior enrollment in the study. Participation in registry studies is permitted.\r\n      ","sponsor":"Algernon Pharmaceuticals","sponsor_type":"Industry","conditions":"Idiopathic Pulmonary Fibrosis","interventions":[{"intervention_type":"Drug","name":"Drug: Ifenprodil","description":"Ifenprodil 20 mg TID"}],"outcomes":[{"outcome_type":"primary","measure":"A ≥50% reduction in the average number of coughs per hour over 24 hours comparing baseline to treatment period using an ambulatory cough monitor","time_frame":"Baseline and week 12 (≥11 weeks of treatment)"},{"outcome_type":"primary","measure":"No worsening of force vital capacity (FVC) in either mL or % predicted","time_frame":"Baseline and week 12 (≥11 weeks of treatment)"}]}
{"nct_id":"NCT04505787","start_date":"2020-07-24","phase":"Phase 1","enrollment":26,"brief_title":"S-flurbiprofen Bioavailability Trial to Compare a Newly Developed Patch vs. a Marketed Tablet","official_title":"Characterisation of Relative Bioavailability of a Newly Developed S-flurbiprofen Containing Patch Formulation in Comparison With a Marketed Oral Flurbiprofen Containing Tablet Formulation - a Multiple Dose, Randomised, 2-period Crossover...","primary_completion_date":"2020-09-09","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-09-24","last_update":"2020-10-22","description":"Teikoku Seiyaku Co., Ltd. (Japan) is developing a new Esflurbiprofen Hydrogel Patch (EFHP), a transdermal product containing 165 mg of the S-enantiomer of flurbiprofen (S-flurbiprofen) as its active pharmaceutical ingredient. The present clinical trial will be conducted to characterise maximum observed systemic exposure of the newly developed EFHP (Test) vs. \"Froben 100 mg\" (Reference, containing 100 mg racemic flurbiprofen in a 1:1 ratio). Characterisation will be performed under steady state conditions in order to bridge the available safety information on the basis of the comparison of maximum observed systemic exposure by means of AUC0-24h,ss,P vs. AUC0-24,ss,T and Cmax,ss,P vs. Cmax,ss,T of S-flurbiprofen.","other_id":"1378fbp19ct","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":64,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. age: 18 to 64 years (inclusive)\r\n\r\n          2. body-mass index (BMI): >= 18.5 kg/m and <= 30.0 kg/m\r\n\r\n          3. good state of health\r\n\r\n          4. non-smoker or ex-smoker for at least 3 months\r\n\r\n          5. written informed consent, after having been informed about benefits and potential\r\n             risks of the clinical trial, as well as details of the insurance taken out to cover\r\n             the subjects participating in the clinical trial\r\n\r\n        Exclusion Criteria:\r\n\r\n        Safety concerns\r\n\r\n          1. existing cardiac and/or haematological diseases or pathological findings, which might\r\n             interfere with the safety or tolerability of the active ingredient\r\n\r\n          2. existing or history of hypertension and/or heart failure\r\n\r\n          3. existing hepatic and/or renal diseases or pathological findings, which might interfere\r\n             with the safety or tolerability, and/or pharmacokinetics of the active ingredient\r\n\r\n          4. existing gastrointestinal diseases or pathological findings, which might interfere\r\n             with the safety, tolerability, absorption and/or pharmacokinetics of the active\r\n             ingredient\r\n\r\n          5. history of gastrointestinal bleeding or perforation related to previous NSAID therapy\r\n\r\n          6. active, or history of, ulcerative colitis, Crohn's disease, peptic ulceration or\r\n             gastrointestinal haemorrhage\r\n\r\n          7. existing metabolic, endocrine and/or immunologic diseases or pathological findings,\r\n             which might interfere with the safety or tolerability, and/or pharmacokinetics of the\r\n             active ingredient\r\n\r\n          8. diabetes mellitus\r\n\r\n          9. hyperlipidaemia (LDL > 160 mg/dL; HDL < 35 mg/dL; triglycerides > 200 mg/dL;\r\n             cholesterol > 240 mg/dL)\r\n\r\n         10. history of relevant CNS and/or psychiatric disorders and/or currently treated CNS\r\n             and/or psychiatric disorders\r\n\r\n         11. presence or history of acute or chronic diseases of the skin (e.g. atopy,\r\n             neurodermatitis, contact allergy, eczema, psoriasis, vitiligo, melanoma, squamous cell\r\n             carcinoma), any dermatological condition or skin sensitivity which might interfere\r\n             with the safety, tolerability, absorption and/or pharmacokinetics of the active\r\n             ingredient\r\n\r\n         12. existing or history of bronchial asthma\r\n\r\n         13. known allergic reactions (e.g. bronchospasm, rhinitis, angioedema, or urticaria) to\r\n             the active ingredients used, to acetylsalicylic acid or other NSAIDs, or to\r\n             constituents of the pharmaceutical preparations\r\n\r\n         14. history of severe allergies or multiple drug allergies unless it is judged as not\r\n             relevant for the clinical trial by the investigator\r\n\r\n         15. fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase\r\n             insufficiency\r\n\r\n         16. galactose intolerance or Lapp lactase deficiency\r\n\r\n         17. systolic blood pressure < 90 or > 139 mmHg\r\n\r\n         18. diastolic blood pressure < 60 or > 89 mmHg\r\n\r\n         19. heart rate < 50 bpm or > 90 bpm\r\n\r\n         20. QTc interval > 450 ms for men and > 470 ms for women\r\n\r\n         21. laboratory values out of normal range unless the deviation from normal is judged as\r\n             not relevant for the clinical trial by the investigator\r\n\r\n         22. ASAT > 20% ULN, ALAT > 10% ULN, bilirubin > 20% ULN (except in case of existing Morbus\r\n             Gilbert-Meulengracht deduced from anamnesis/medical history) and creatinine > 0.1\r\n             mg/dL ULN (limit of > 0.1 mg/dL correspondents to of > 9 mol/l ULN).\r\n\r\n         23. positive anti-HIV-test (if positive to be verified by western blot), HBs-AG-test or\r\n             anti-HCV-test\r\n\r\n         24. symptoms of, or diagnosis of COVID-19 within the last 14 days prior to individual\r\n             enrolment of the subject\r\n\r\n         25. contact to persons in risk regions as defined by the Robert Koch Institute within the\r\n             last 14 days prior to individual enrolment of the subject\r\n\r\n         26. direct contact to persons with symptoms of, or diagnosis of COVID-19 within the last\r\n             14 days prior to individual enrolment of the subject Lack of suitability for the\r\n             clinical trial\r\n\r\n         27. skin abnormality (e.g. tattoo (including tattoo that was removed), scar, sunburn or\r\n             obvious difference in skin colour), open sores, or excessive hair at the application\r\n             site\r\n\r\n         28. acute or chronic diseases which may interfere with the pharmacokinetics of the IMP\r\n\r\n         29. history of or current drug or alcohol dependence\r\n\r\n         30. positive alcohol or drug test at screening examination\r\n\r\n         31. regular intake of alcoholic food or beverages of >= 24 g pure ethanol for male or >=\r\n             12 g pure ethanol for female per day\r\n\r\n         32. subjects who are on a diet which could affect the pharmacokinetics of the active\r\n             ingredient\r\n\r\n         33. regular intake of caffeine containing food or beverages of >= 500 mg caffeine per day\r\n\r\n         34. blood donation or other blood loss of more than 400 ml within the last 2 months prior\r\n             to individual enrolment of the subject\r\n\r\n         35. administration of any investigational medicinal product during the last 2 months prior\r\n             to individual enrolment of the subject\r\n\r\n         36. regular treatment with any systemically available medication (except hormonal\r\n             contraceptives and hormonal replacement therapy, e.g. estrogens, L-thyroxine)\r\n\r\n         37. subjects, who report a frequent occurrence of migraine attacks\r\n\r\n             For female subjects with childbearing potential only:\r\n\r\n         38. positive pregnancy test at screening examination\r\n\r\n         39. pregnant or lactating women\r\n\r\n         40. female subjects who do not agree to apply highly effective contraceptive methods\r\n             Administrative reasons\r\n\r\n         41. subjects suspected or known not to follow instructions\r\n\r\n         42. subjects who are unable to understand the written and verbal instructions, in\r\n             particular regarding the risks and inconveniences they will be exposed to during their\r\n             participation in the clinical trial\r\n      ","sponsor":"SocraTec R&D GmbH","sponsor_type":"Other","conditions":"Comparative Bioavailability","interventions":[{"intervention_type":"Drug","name":"Drug: Esflurbiprofen hydrogel patch 165 mg (EFHP)","description":"patch application with PK blood sampling"},{"intervention_type":"Drug","name":"Drug: Froben 100 mg comprimidos revestidos","description":"tablet administration with PK blood sampling"}],"outcomes":[{"outcome_type":"primary","measure":"Assessment of non-superiority of Test in comparison to Reference under steady-state conditions determined by use of AUC0-24,ss,P vs. AUC0-24,ss,T of S-flurbiprofen","time_frame":"24 hours","description":"AUC0-24,ss,P = area under the plasma concentration vs. time curve from dosing time to the end of the dosing interval (profiling day after 14th patch application), calculated by means of the linear up/log down method (linear trapezoidal rule for increases in concentration/logarithmic trapezoidal rule for decreases in concentrations AUC0-24,ss,T = area under the plasma concentration vs. time profile over 24 h at profiling day from dosing time of 10th administration to 8 h after 12th administration, calculated by means of the linear up/log down method (linear trapezoidal rule for increases in concentration/logarithmic trapezoidal rule for decreases in concentrations"},{"outcome_type":"primary","measure":"Assessment of non-superiority of Test in comparison to Reference under steady-state conditions determined by use of Cmax,ss,P vs. Cmax,ss,T of S flurbiprofen","time_frame":"24 hours","description":"Cmax,ss,P = maximum concentration in plasma within the dosing interval (profiling day after 14th patch application), obtained directly from measured values Cmax,ss,T = maximum concentration over 24 h at profiling day from dosing time of 10th administration to 8 h after 12th administration, obtained directly from measured values"},{"outcome_type":"secondary","measure":"Skin irritation properties for Esflurbiprofen hydrogel patch by frequency of scores","time_frame":"16 days","description":"frequency of scores for local tolerability and skin irritation per time point according to \"Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs\", Guidance for Industry, DRAFT. 2018 October"},{"outcome_type":"secondary","measure":"Patch adhesion properties for Esflurbiprofen hydrogel patch by percentage of adhered patch area","time_frame":"15 days","description":"documentation of the percentage of area that remains adhered and scoring (i.e. percentage of adhered area and scores will be matched/combined) per time point according to \"Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs\", Guidance for Industry, DRAFT. 2018 October"},{"outcome_type":"secondary","measure":"Adverse Events","time_frame":"28 days","description":"Descriptive characterisation with regard to frequency and intensity, relationship to the IMP, action taken, outcome, and seriousness as well as period and treatment"}]}
{"nct_id":"NCT04471376","start_date":"2020-07-16","phase":"N/A","enrollment":66,"brief_title":"The Effect of Sugammadex During Transcranial Electrical Motor Evoked Potential Monitoring in Spinal Surgery","official_title":"Intraoperative Reversal of Muscle Relaxants During Transcranial Electrical Motor Evoked Potential Monitoring in Patients Undergoing Spinal Surgery","primary_completion_date":"2020-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-12-31","last_update":"2021-04-06","description":"Transcranial motor evoked potential (TcMEP) monitoring is conventionally performed during neurosurgical procedures without or with minimal neuromuscular blockade (NMB) because of its potential interference with signal interpretation. However, full blockade offers increased anesthetic management options and facilitates surgery. Here, investigators want to assess the effect of Sugammadex during TcMEP in adult patients. Sugammadex is designed to encapsulate rocuronium and reverse rocuronium-induced neuromuscular blockade. 64 patients undergoing thoracic or lumbar spinal surgery will be randomly allocated into sugammadex group or control group under a ratio of 1 to 1. Patients will receive either continuous infusion of rocuronium to produce blockade maintained at least two twitches in Train-of-Four (TOF), rocuronium infusion will be discontinued and 2 mg/kg of sugammadex will be infused while dura opening in sugammadex group. Whereas no muscle relaxant will be given after anesthetic induction in control group. The primary aim of this study is to compare mean value of amplitudes of TcMEPs in abductor pollicis brevis muscles of both upper extremities 5 minutes after dura opening.","other_id":"WJP20200708","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18-65 years\r\n\r\n          -  ASA status I-II\r\n\r\n          -  Patients undergo thoracic or lumbar spinal surgery\r\n\r\n          -  tcMEP monitoring during the surgery\r\n\r\n          -  Informed consent signed by patients\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  BMI 35 Kg/m-2\r\n\r\n          -  history of epilepsy or use of antiepileptic drugs, neuromuscular disorder(s)\r\n\r\n          -  history or family history of malignant hyperthermia\r\n\r\n          -  allergies to sugammadex, NMBs or other medication(s) used during general anesthesia\r\n\r\n          -  anemia, hemoglobin <110g/L,\r\n\r\n          -  TcMEPs stimulate or record site infection\r\n\r\n          -  preoperative neurological dysfunction in both upper extremities\r\n\r\n          -  cardiac pacemaker\r\n\r\n          -  pregnancy and breast-feeding\r\n      ","sponsor":"Beijing Tiantan Hospital","sponsor_type":"Other","conditions":"Sugammadex","interventions":[{"intervention_type":"Drug","name":"Drug: Sugammadex","description":"Sugammadex group received a rocuronium infusion producing blockade by qualitative train-of-four 2 at the ulnar nerve. 2 mg/kg of Sugammadex will be infused when conducting TcMEP"}],"outcomes":[{"outcome_type":"primary","measure":"The amplitude of MEP","time_frame":"5 minutes after dura opening","description":"mean value of amplitudes of TceMEPs in abductor pollicis brevis muscles of both upper extremities"},{"outcome_type":"secondary","measure":"The amplitude of MEP","time_frame":"10, 20, 30 and 60 minutes after dura opening","description":"Mean value of amplitudes of TceMEPs in abductor pollicis brevis muscles of both upper extremities 10, 20, 30 and 60 minutes after dura opening."},{"outcome_type":"secondary","measure":"The latencies of MEPs","time_frame":"5, 10, 20, 30 and 60 minutes after dura opening.","description":"Mean value of latencies of TceMEPs in abductor pollicis brevis muscles of both upper extremities"},{"outcome_type":"secondary","measure":"Respiratory parameters","time_frame":"during the surgery","description":"Peak respiratory pressures and incidence of peak insufflation pressure of more than 25cmH2O."},{"outcome_type":"secondary","measure":"Adverse effects of sugammadex","time_frame":"during and 24 hours after the surgery","description":"Anaphylaxis, arrhythmias, post-procedure pain, nausea and vomiting, fever and diarrhea, etc."},{"outcome_type":"secondary","measure":"Incidence of body movement","time_frame":"during the surgery","description":"either nociception-induced movement (defined as \"coughing\" or reflexive limb movement temporally related to MEP stimulation) or excessive field movement (defined as grossly visible movement as determined by surgical and anesthesia teams)."},{"outcome_type":"secondary","measure":"Recurrence of neuromuscular blockade","time_frame":"At the end of surgery","description":"Recurrence of neuromuscular blockade at the end of surgery."},{"outcome_type":"secondary","measure":"Motor function assessment","time_frame":"5 days after surgery","description":"SMP-a scale"},{"outcome_type":"secondary","measure":"Total bleeding volume","time_frame":"during the surgery","description":"Total bleeding volume during the surgery"}]}
{"nct_id":"NCT04232514","start_date":"2020-07-15","phase":"Phase 1","enrollment":28,"brief_title":"Drug-drug Interaction Study Between HEC74647PA Capsule and HEC110114 Tablets in Healthy Subjects","official_title":"A Open-label, Single Center Drug Interaction Study Between HEC74647PA Capsule and HEC110114 in Healthy Subjects","primary_completion_date":"2020-08-10","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-08-22","last_update":"2020-11-05","description":"The purpose of this study is to evaluate the drug-drug-interaction (DDI), pharmacokinetics (PK) and tolerability of HEC74647 combined with HEC110114 in healthy subjects","other_id":"HEC74647-P-03","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Sign the informed consent form before the trial and fully understand the contents of\r\n             the trial, the process and possible adverse reactions.\r\n\r\n          -  Be able to complete the study according to the trail protocol.\r\n\r\n          -  Subjects (including partners) have no pregnancy plan within 3 months after the last\r\n             dose of study drug and voluntarily take effective contraceptive measures.\r\n\r\n          -  Male subjects and must be 18 to 45 years of age inclusive.\r\n\r\n          -  Body weight  50 kg and body mass indexBMIbetween 18 and 28 kg / m2, inclusive.\r\n\r\n          -  Physical examination and vital signs without clinically significant abnormalities.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Use of >5 cigarettes per day during the past 3 months.\r\n\r\n          -  Known history of allergy to study drugsor allergies constitution ( multiple drug and\r\n             food allergies).\r\n\r\n          -  History of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25\r\n             mL of spirits or 100 mL of wine).\r\n\r\n          -  Donation or loss of blood over 450 mL within 3 months prior to screening.\r\n\r\n          -  12-lead ECG with clinically significant.\r\n\r\n          -  Positive for Viral hepatitis (including hepatitis B and C), HIV and syphilis.\r\n\r\n          -  Subjects deemed unsuitable by the investigator for any other reason.\r\n      ","sponsor":"Sunshine Lake Pharma Co., Ltd.","sponsor_type":"Industry","conditions":"Chronic Hepatitis C","interventions":[{"intervention_type":"Drug","name":"Drug: HEC74647","description":"Administered HEC74647 200 mg orally once daily in fed state"},{"intervention_type":"Drug","name":"Drug: HEC110114","description":"Administered HEC110114 800 mg orally once daily in fed state"}],"outcomes":[{"outcome_type":"primary","measure":"Adverse Events","time_frame":"From Days 1-26","description":"Incidence of adverse events"},{"outcome_type":"primary","measure":"Cmax","time_frame":"Day 7-12 and Day 19-26","description":"Maximum plasma concentration of study drugs"},{"outcome_type":"primary","measure":"AUC","time_frame":"Day 7-12 and Day 19-26","description":"Maximum plasma concentration of study drugs"}]}
{"nct_id":"NCT04446663","start_date":"2020-07-15","phase":"Phase 2","enrollment":50,"brief_title":"Toripalimab Combined With Chemoradiotherapy in Patients With Locoregionally-advanced Nasopharyngeal Carcinoma","official_title":"Toripalimab Combined With Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal Carcinoma: an Open-label, Parallel Controlled, Phase IIa Study","primary_completion_date":"2023-12-15","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2024-12-15","last_update":"2020-06-25","description":"This is an open-label, parallel controlled, phase IIa exploratory study that evaluates the efficacy and safety of Toripalimab (PD-1 Antibody) combined with induction chemotherapy Albumin-bound paclitaxel and cisplatin and concurrent chemoradiotherapy in the treatment of nasopharyngeal carcinoma and explores the biomarkers that can predict the efficacy and toxicity of the treatment.","other_id":"JS001-ISS-CO185","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Only the patients meeting all the following criteria can be eligible to participate in\r\n             the trial:\r\n\r\n               1. Fully understand this study and voluntarily sign the informed consent form (ICF);\r\n                  have good compliance;\r\n\r\n               2. Patients with newly histologically confirmed non-keratinizing nasopharyngeal\r\n                  carcinoma, including WHO II or III ;\r\n\r\n               3. locoregionally advanced nasopharyngeal carcinoma (LANPC)T3-4N0-1M0/T1-4N2-3M0;\r\n\r\n               4. Age 18 to 70 years;\r\n\r\n               5. ECOG PS 0-1;\r\n\r\n               6. The laboratory examination results before enrollment must meet the following\r\n                  standards:\r\n\r\n                    1. Neutrophils 1.5  109 / L;\r\n\r\n                    2. Platelets 100  109 / L;\r\n\r\n                    3. Hemoglobin 90g / L (no infusion of concentrated red blood cells within 4\r\n                       weeks);\r\n\r\n                    4. Serum creatinine  1.5  ULN and creatinine clearance  60 mL / min;\r\n\r\n                    5. Total serum bilirubin  1.5  ULN;\r\n\r\n                    6. AST and ALT  2.5  ULN;\r\n\r\n                    7. The ULN of coagulation parameters APTT is not extended for more than 10\r\n                       seconds, and the ULN of PT is not extended for more than 3 seconds;\r\n\r\n               7. Women of childbearing age must confirm that the serum pregnancy test is negative\r\n                  and agree to use effective contraception during drug use and within 1 year after\r\n                  the last doseMen whose female partners have the ability to become pregnant must\r\n                  agree to use reliable contraception within 1 year from the screening visit to the\r\n                  last Toripalimab administration.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Women of child-bearing potential are pregnant or breastfeeding ;\r\n\r\n          2. Have known allergy to large molecule protein products or any compound of Toripalimab;\r\n\r\n          3. Central nervous system metastases with clinical symptoms accompanied by cerebral\r\n             edema, requiring hormone intervention, or progression of brain metastases;\r\n\r\n          4. Prior malignancy within 5 years, except carcinoma in situ of the cervix, adequately\r\n             treated basal cell carcinoma of the skin and papillary thyroid carcinoma;\r\n\r\n          5. Received any of the following treatments:\r\n\r\n               1. Patients who have been treated with inhibitors of immune regulation (CTLA-4,\r\n                  PD-1, PD-L1, etc.);\r\n\r\n               2. Received any research drug within 4 weeks before the first administration of the\r\n                  drug;\r\n\r\n               3. Join another clinical study at the same time, unless it is an observational\r\n                  (non-interventional) study or intervention study during follow-up;\r\n\r\n               4. Within 28 days before signing the informed consent, received an equivalent dose\r\n                  of >10 mg prednisone/day or other immunosuppressive therapy, and a systemic\r\n                  hormone dose of 10 mg prednisone/day or inhaled/topical corticosteroids;\r\n\r\n               5. Have been vaccinated with anti-tumor vaccines or have been vaccinated with live\r\n                  vaccines within 4 weeks before the first administration of study drugs;\r\n\r\n               6. Have undergone major surgery or severe trauma within 4 weeks before the first\r\n                  administration of study drugs;\r\n\r\n          6. Uncontrolled clinical symptoms or diseases of the heart, such as: (1) Heart failure\r\n             above NYHA level II (2) Unstable angina (3) Myocardial infarction occurred within 1\r\n             year (4) Clinically supraventricular or Patients with ventricular arrhythmias\r\n             requiring clinical intervention;\r\n\r\n          7. Serious infections (CTCAE>2) within 4 weeks before the first use of the study drug,\r\n             such as severe pneumonia, bacteremia, and infection comorbidities that require\r\n             hospitalization; baseline chest imaging examinations suggest active lung inflammation\r\n             . The symptoms and signs of infection exist within 2 weeks before the first dose or\r\n             require oral or intravenous antibiotic use (excluding prophylactic antibiotic use);\r\n\r\n          8. Have a history of interstitial lung disease and non-infectious pneumonia;\r\n\r\n          9. Have active tuberculosis infection, or have a history of active tuberculosis infection\r\n             within 1 year before enrollment, or have active tuberculosis infection one year ago\r\n             but have not been formally treated;\r\n\r\n         10. Have active autoimmune diseases or a history of autoimmune diseases (such as\r\n             interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis,\r\n             nephritis, hyperthyroidism, hypothyroidism, including but not limited to These\r\n             diseases and syndromes); Autoimmune-mediated hypothyroidism treated with stable doses\r\n             of thyroid replacement hormone; Type I diabetes with stabilized doses of insulin; but\r\n             excluding vitiligo or cured childhood asthma/allergy who do not require any\r\n             intervention in adults;\r\n\r\n         11. A history of HIV infection, or other acquired, congenital immunodeficiency diseases,\r\n             or a history of organ transplantation and bone marrow transplantation;\r\n\r\n         12. Have active hepatitis HBsAg positive and HBV DNA 2000IU/ml or 1000 copies/ml,\r\n             hepatitis C (hepatitis C antibody positive, and HCV-RNA is higher than the detection\r\n             limit);\r\n\r\n         13. Known history of psychotropic substance abuse, alcoholism and drug abuse;\r\n\r\n         14. Any other disease or condition of clinical significance that the investigator believes\r\n             may affect protocol compliance, or affect the signing of an ICF, or is not suitable\r\n             for participation in this clinical trial.\r\n      ","sponsor":"First People's Hospital of Foshan","sponsor_type":"Other","conditions":"Nasopharyngeal Neoplasms","interventions":[{"intervention_type":"Drug","name":"Drug: Toripalimab","description":"Toripalimab 240mg ivdrip, every 3 weeks for 6 cycles, with 3 cycles combined with induction chemotherapy, 3 cycles combined with concurrent chemoradiotherapy"},{"intervention_type":"Drug","name":"Drug: Albumin-bound Paclitaxel","description":"Albumin-bound Paclitaxel 260 mg/m2, d1 of every cycle, every 3 weeks for 3 cycles before radiotherapy"},{"intervention_type":"Drug","name":"Drug: Cisplatin","description":"Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiotherapy Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiotherapy"},{"intervention_type":"Radiation","name":"Radiation: intensity-modulated radiotherapy","description":"Definitive IMRT of 66 Gy will be given ."}],"outcomes":[{"outcome_type":"primary","measure":"Adverse events","time_frame":"2 years","description":"Incidence of adverse events as assessed by CTCAE v5.0"},{"outcome_type":"secondary","measure":"Overall survival (OS)","time_frame":"3 years","description":"calculated from randomization to the date of death from any cause."},{"outcome_type":"secondary","measure":"Distant failure-free survival (DFFS)","time_frame":"3 years","description":"calculated from randomization to the date of first distant metastasis."},{"outcome_type":"secondary","measure":"Locoregional failure-free survival (LRFFS)","time_frame":"3 years","description":"calculated from randomization to the date of locoregional persistence or 1st locoregional recurrence"},{"outcome_type":"secondary","measure":"Overall response rate （ORR）and Complete response rate（CR）","time_frame":"2 years","description":"Defined as percentage of participants achieving complete response (CR) and partial response (PR) according to the RECIST 1.1."},{"outcome_type":"secondary","measure":"Quality of life (QoL)","time_frame":"3 years","description":"The change of QoL from randomization to 12 months after chemoradiation. The European Organization for Research and Treatment of Cancer quality of life questionnaire-C30 (EORTC QLQ-C30）version 3.0 will be used. This questionnaire comprises 30 questions, 24 of which are aggregated into nine multi-question scales, that is, five functioning scales (e.g., physical), three symptom scales (e.g., fatigue) and one global health status scale. The remaining six single-question (e.g., dyspnoea) scales assess symptoms. These 15 scales will be scored according to the official Scoring Manual: 1. Estimate the average of the questions that contribute to the scale; this is the raw score. 2. Use a linear transformation to standardise the raw score, so that scores range from 0 to 100. Thus, a high score for a functional scale represents a high level of functioning, a high score for the global health status represents a high QoL, but a high score for a symptom scale represents a high level of problems."}]}
{"nct_id":"NCT04486599","start_date":"2020-07-15","phase":"N/A","enrollment":30,"brief_title":"Electromagnetic Navigation During Ultrasound Guided Foam Sclerotherapy for Venous Malformations","official_title":"Feasibility of Electromagnetic Navigation During Ultrasound Guided Foam Sclerotherapy for the Treatment of Venous Malformations.","primary_completion_date":"2022-07-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-07-30","last_update":"2020-11-12","description":"The aim of this study is to evaluate the feasibility of assisted electromagnetic navigation in percutaneous echo-guided sclerotherapy of slow-flow vascular malformations. Feasibility will be defined in terms of the percentage of patients for whom the procedure is successful.","other_id":"RC31/19/0516","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Low Flow Vascular Abnormality diagnosed by Duplex Ultrasound and MRI\r\n\r\n          -  Decision of Ultrasound Guided Percutaneous Foam Sclerotherapy taken in\r\n             multidisciplinary staff meeting\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  patients with pacemakers or internal defibrillator\r\n\r\n          -  patients with ferromagnetic implanted material\r\n\r\n          -  patients who are wards of court or under guardianship\r\n\r\n          -  patients deprived of freedom by judicial or administrative decision\r\n\r\n          -  patients under legal protection\r\n\r\n          -  pregnant women\r\n      ","sponsor":"University Hospital, Toulouse","sponsor_type":"Other","conditions":"Venous Malformation","interventions":[{"intervention_type":"Device","name":"Device: Electromagnetic Navigation","description":"The echo-guided sclerotherapy procedure, assisted by electromagnetic navigation, will be carried out in a clean room during the day hospitalisation and followed by a control Echo-Doppler carried out 2 hours after the procedure."}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of patients for whom the procedure is successful","time_frame":"day 1","description":"Success of procedure a.e. obtention of venous flow at the extremity of the needle permitting the realization of the foam sclerotherapy treatment."},{"outcome_type":"secondary","measure":"Estimate the number of punctures required to achieve catheterization of the malformation.","time_frame":"day 1","description":"Number of percutaneous punctures needed to obtain vascular backflow."},{"outcome_type":"secondary","measure":"Estimate the time to complete catheterization of the malformation","time_frame":"day 1","description":"Duration of the procedure."},{"outcome_type":"secondary","measure":"Estimate the undesirable effects associated with assisted electromagnetic navigation.","time_frame":"day 1","description":"Adverse effects of Electro-Magnetic Navigation."}]}
{"nct_id":"NCT04405843","start_date":"2020-07-14","phase":"Phase 2/Phase 3","enrollment":476,"brief_title":"Efficacy of Ivermectin in Adult Patients With Early Stages of COVID-19 (EPIC Trial)","official_title":"Randomized, Placebo Controlled, Double Blind Clinical Trial to Evaluate the Efficacy of Molecule D11AX22 in Adults Patients From Valle Del Cauca, Colombia With Early Stages of SARS COV2 / COVID-19","primary_completion_date":"2020-12-21","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-12-21","last_update":"2020-12-28","description":"Double blind, placebo controlled, randomized clinical trial to evaluate the efficacy of ivermectin in preventing progression of disease in adult patients with early stages of COVID-19","other_id":"ScDi823","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  At least 18 years of age\r\n\r\n          -  Confirmed SARS-CoV-2 by RT-PCR or antigen detection in a Colombian NIH-approved\r\n             laboratory\r\n\r\n          -  Beginning of symptoms in the past 7 days\r\n\r\n          -  Mild disease\r\n\r\n          -  Informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Preexisting liver disease\r\n\r\n          -  Hypersensitivity to ivermectin\r\n\r\n          -  Participants in other clinical trials for therapies against COVID-19\r\n\r\n          -  Severe pneumonia\r\n\r\n          -  Pregnant or breastfeeding women\r\n\r\n          -  Concomitant use of warfarin, erdafitinib or quinidine\r\n\r\n          -  Use of ivermectin in the 5 days prior to randomization\r\n\r\n          -  Inability to obtain a blood sample needed to assess liver transaminases\r\n\r\n          -  Elevation of transaminases >1.5 times the normal level\r\n\r\n          -  Participant whose first contact with the study personnel occurs between days 5 and 7\r\n             and at that time manifests significant and progressive resolution of COVID-19 related\r\n             signs and symptoms\r\n      ","sponsor":"Centro de Estudios en Infectoga Pediatrica","sponsor_type":"Other","conditions":"COVID-19","interventions":[{"intervention_type":"Drug","name":"Drug: Ivermectin Oral Product","description":"Ivermectin oral suspension, 6 mg/mL"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Substance with similar physical and organoleptic characteristics as ivermectin, without the active drug ingredient"}],"outcomes":[{"outcome_type":"primary","measure":"Time to event","time_frame":"21 days","description":"Time until resolution of symptoms"},{"outcome_type":"secondary","measure":"Clinical condition on day 2","time_frame":"On day 2 (± 1 day) after randomization","description":"Clinical condition in an ordinal scale of 7 points, on day 2. Higher scores indicate worse outcomes"},{"outcome_type":"secondary","measure":"Clinical condition on day 5","time_frame":"On day 5 (± 1 day) after randomization","description":"Clinical condition in an ordinal scale of 7 points, on day 5. Higher scores indicate worse outcomes"},{"outcome_type":"secondary","measure":"Clinical condition on day 8","time_frame":"On day 8 (± 1 day) after randomization","description":"Clinical condition in an ordinal scale of 7 points, on day 8. Higher scores indicate worse outcomes"},{"outcome_type":"secondary","measure":"Clinical condition on day 11","time_frame":"On day 11 (± 1 day) after randomization","description":"Clinical condition in an ordinal scale of 7 points, on day 11. Higher scores indicate worse outcomes"},{"outcome_type":"secondary","measure":"Clinical condition on day 15","time_frame":"On day 15 (± 1 day) after randomization","description":"Clinical condition in an ordinal scale of 7 points, on day 15. Higher scores indicate worse outcomes"},{"outcome_type":"secondary","measure":"Clinical condition on day 21","time_frame":"On day 21 (± 1 day) after randomization","description":"Clinical condition in an ordinal scale of 7 points, on day 21. Higher scores indicate worse outcomes"},{"outcome_type":"secondary","measure":"Proportion of subjects with additional care","time_frame":"21 days","description":"Proportion of subjects who require hospitalization, use of supplementary oxygen for >24 hours or ICU admission"},{"outcome_type":"secondary","measure":"Proportion of subjects who die","time_frame":"From randomization up to 21 days","description":"Proportion of subjects who die"},{"outcome_type":"secondary","measure":"Duration of additional care","time_frame":"21 days","description":"Duration of supplementary oxygen, hospitalization, ICU stay"},{"outcome_type":"secondary","measure":"Adverse events","time_frame":"21 days","description":"Proportion of subjects who develop solicited adverse events"},{"outcome_type":"secondary","measure":"Proportion of subjects who discontinue intervention","time_frame":"21 days","description":"Proportion of subjects who required discontinuation of the intervention due to adverse events"},{"outcome_type":"secondary","measure":"Time to event","time_frame":"21 days","description":"Time until deterioration of 2 or more points in an ordinal 7 points scale."},{"outcome_type":"secondary","measure":"Duration of fever","time_frame":"21 days","description":"Number of days with fever since randomization"}]}
{"nct_id":"NCT04468412","start_date":"2020-07-14","enrollment":203,"brief_title":"Influence of COVID-19 on Vascular Endothelial Function","official_title":"Influence of COVID-19 on Vascular Endothelial Function","primary_completion_date":"2021-09-30","study_type":"Observational","rec_status":"Active, not recruiting","completion_date":"2021-09-30","last_update":"2021-09-16","description":"Rationale: Infection with severe acute respiratory syndrome coronavirus (SARS-CoV) 2 could result in endothelial dysfunction with increased risk of arterial thrombotic events by downregulating the expression of angiotensin converting enzyme 2 (ACE2). Endothelial function can be easily and non-invasively determined by carotid artery reactivity (CAR) testing. Objective: To investigate the predictive value of endothelial dysfunction, measured by carotid artery reactivity testing, for 1-year cardiovascular events in patients with past COVID-19 infection. Study design: A prospective observational longitudinal cohort study. Study population: Patients recovered from confirmed infection with SARS-CoV2. Main study parameters/endpoints: macrovascular endothelial function measured by carotid artery reactivity testing.","other_id":"NL2020-6555","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":16,"population":"Patients with past COVID-19 infection will be recruited at Bernhoven hospital, the\r\n        Netherlands.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Confirmed SARS-CoV2 infection by polymerase chain reaction on nasopharyngeal swab,\r\n             sputum or bronchoalveolar lavage.\r\n\r\n          -  At least 6 and no more than 20 weeks after resolution of COVID-19 related symptoms\r\n\r\n          -   16 years old\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Recent (<3 months) angina pectoris, myocardial infarction, stroke, or heart failure\r\n\r\n          -  Raynaud syndrome, scleroderma, complex regional pain syndrome of the upper extremity\r\n             or presence of arteriovenous fistula or open wounds on both the upper extremities.\r\n      ","sponsor":"Radboud University","sponsor_type":"Other","conditions":"COVID|Vascular; Damage","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Carotid Artery Reactivity Testing","description":"The carotid artery reactivity (CAR) test assesses macrovascular endothelial function by measuring the carotid artery diameter in response to sympathetic stimulation. Participants are in the supine position with the neck extended for assessment of the carotid artery. Left carotid artery diameter is recorded continuously during baseline (30 seconds) and during immersion of the right hand up to the wrist in icy water (4C) for 3 minutes. CAR can either represent a dilatory response (normal endothelial function) or a constrictive response (endothelial dysfunction) of the carotid artery."}],"outcomes":[{"outcome_type":"primary","measure":"Endothelial dysfunction","time_frame":"CAR will be measures between 6 and 20 weeks and 1 year after recovery from COVID-19.","description":"Change in endothelial dysfunction as determined by CAR test."},{"outcome_type":"secondary","measure":"Major adverse cardiovascular events (MACE)","time_frame":"1 year","description":"MACE include non-fatal myocardial infarction, non-fatal ischemic stroke, acute limb ischemia, need for revascularization, amputation and cardiovascular death."}]}
{"nct_id":"NCT04422392","start_date":"2020-07-13","phase":"Phase 2","enrollment":107,"brief_title":"Neoadjuvant PD-1 Antibody Plus Chemotherapy in Resectable Stage IIIA-N2 Non-Small-Cell Lung Cancer","official_title":"Neoadjuvant PD-1 Antibody Plus Chemotherapy in Resectable Stage IIIA-N2 Non-Small-Cell Lung Cancer: A Randomized Phase II Study","primary_completion_date":"2022-06-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2025-06-30","last_update":"2021-02-21","description":"This is a randomized, open label study designed to evaluate the efficacy and safety of neoadjuvant PD-1 antibody plus chemotherapy followed by surgery in resectable stage IIIA-N2 non-small cell lung cancer.","other_id":"NALAN-01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Written informed consent provided.\r\n\r\n          -  Males or females aged 18 years.\r\n\r\n          -  Pathologically diagnosed of non-small cell lung cancer.\r\n\r\n          -  Diagnosed as stage IIIA- N2.The diagnosis standard of N2 is as below: Pts with\r\n             resectable stage IIIA-N2 NSCLC confirmed by mediastinoscopy or EBUS and PET/CT.\r\n\r\n          -  Tumor should be considered resectable before study entry by a multidisciplinary team.\r\n\r\n          -  ECOG (Performance status) 0-1.\r\n\r\n          -  Screening laboratory values must meet the following criteria and should be obtained\r\n             within 7 days prior to randomization.\r\n\r\n             i. Neutrophils  1500109/L ii. Platelets  100 x109/L iii. Hemoglobin > 9.0 g/dL iv.\r\n             Serum creatinine  1.5 x ULN or creatinine clearance (CrCl)  40 mL/min v. AST/ALT  3\r\n             x ULN vi. Total Bilirubin  1.5 x ULN (except subjects with Gilbert Syndrome, who can\r\n             have total bilirubin < 3.0 mg/dL) vii. The patients need to have a forced expiratory\r\n             volume (FEV1)  1.2 liters or >40% predicted value viii. INR/APTT within normal\r\n             limits.\r\n\r\n          -  Women of childbearing potential, including women who had their last menstrual period\r\n             in the last 2 years, must have a negative serum or urine pregnancy test within 7 days\r\n             before randomization.\r\n\r\n          -  All sexually active men and women of childbearing potential must use an effective\r\n             contraceptive method (two barrier methods or a barrier method plus a hormonal method)\r\n             during the study treatment and for a period of at least 12 months following the last\r\n             administration of trial drugs.\r\n\r\n          -  Patient capable of proper therapeutic compliance and accessible for correct follow-up.\r\n\r\n          -  Measurable or evaluable disease (according to RECIST 1.1 criteria).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  All patients carrying activating mutations in the TK domain of EGFR or any variety of\r\n             alterations in the ALK gene.\r\n\r\n          -  Patients with a condition requiring systemic treatment with either corticosteroids\r\n             (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14\r\n             days of randomization. Inhaled or topical steroids, and adrenal replacement steroid\r\n             doses > 10 mg daily prednisone equivalent, are permitted in the absence of active\r\n             autoimmune disease.\r\n\r\n          -  Patients with a history of interstitial lung disease cannot be included if they have\r\n             symptomatic ILD (Grade 3-4) and/or poor lung function. In case of doubt please contact\r\n             trial team.\r\n\r\n          -  Patients with other active malignancy requiring concurrent intervention and/or\r\n             concurrent treatment with other investigational drugs or anti-cancer therapy.\r\n\r\n          -  Patients with previous malignancies (except non-melanoma skin cancers, and the\r\n             following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia,\r\n             melanoma, or breast) are excluded unless a complete remission was achieved at least 2\r\n             years prior to study entry AND no additional therapy is required during the study\r\n             period.\r\n\r\n          -  Any medical, mental or psychological condition which in the opinion of the\r\n             investigator would not permit the patient to complete the study or understand the\r\n             patient information.\r\n\r\n          -  Patients who have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2,\r\n             anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell\r\n             costimulation or immune checkpoint pathways.\r\n\r\n          -  Patients with positive test for hepatitis B virus surface antigen (HBV sAg) or\r\n             hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic\r\n             infection.\r\n\r\n          -  Patients with known history of testing positive for human immunodeficiency virus (HIV)\r\n             or known acquired immunodeficiency syndrome (AIDS).\r\n\r\n          -  Patients with history of allergy to study drug components excipients.\r\n\r\n          -  Women who are pregnant or in the period of breastfeeding.\r\n\r\n          -  Sexually active men and women of childbearing potential who are not willing to use an\r\n             effective contraceptive method during the study.\r\n      ","sponsor":"Shanghai Pulmonary Hospital, Shanghai, China","sponsor_type":"Other","conditions":"Non Small Cell Lung Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Carboplatin","description":"(IV, Q3W)"},{"intervention_type":"Drug","name":"Drug: Pemetrexed or Nab-paclitaxel","description":"Pemetrexed (Nonsquamous NSCLC) or Nab-paclitaxel (Squamous NSCLC) (IV, Q3W)"},{"intervention_type":"Drug","name":"Drug: PD-1 antibody","description":"(IV, Q3W)"}],"outcomes":[{"outcome_type":"primary","measure":"PFS at 24 months","time_frame":"From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.","description":"The PFS is defined as the time from diagnosis to relapse, progression or death, whichever occurred first."}]}
{"nct_id":"NCT04233034","start_date":"2020-07-09","phase":"Phase 3","enrollment":131,"brief_title":"Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes","official_title":"Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes (CLVer)","primary_completion_date":"2022-08-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-08-31","last_update":"2021-07-30","description":"Randomized trial of youth aged 7-<18 years with newly diagnosed stage 3 type 1 diabetes (T1D) to assess the effect of both (1) near-normalization of glucose concentrations achieved through use of a hybrid closed loop (HCL) system and (2) verapamil on preservation of -cell function 12 months after diagnosis. Participants with body weight 30 kg (Cohort A) will be randomly assigned in a factorial design to (1) HCL plus intensive diabetes management or usual care with no HCL and (2) verapamil or placebo. Participants with body weight <30 kg (Cohort B) will be randomly assigned 2:1 in a parallel group design to HCL plus intensive diabetes management or to usual care with no HCL.","other_id":"CLVer","allocation":"Randomized","intervention_model":"Factorial Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":7,"maximum_age":17,"population":"","criteria":"\n        -  Participant Inclusion Criteria:\r\n\r\n               1. New-onset stage 3 T1D within 21 days of diagnosis (timed from start of insulin\r\n                  therapy), with ability to be randomized within 31 days of diagnosis (time from\r\n                  diagnosis to screening can be longer provided all screening testing can be\r\n                  completed within 31 days of diagnosis)\r\n\r\n               2. At least one positive type 1 diabetes auto-antibody\r\n\r\n               3. Age 7 - <18 years at the time of enrollment\r\n\r\n               4. Willing to have a parent or legal guardian provide informed consent and child\r\n                  assent\r\n\r\n               5. In a female participant with childbearing potential, not currently pregnant and\r\n                  willing to avoid pregnancy and breastfeeding and undergo pregnancy testing\r\n                  throughout the study\r\n\r\n               6. English speaking/reading\r\n\r\n               7. Able to swallow pills (tested with an inert imitation tablet in clinic prior to\r\n                  randomization)\r\n\r\n               8. Willing to not use any non-insulin glucose-lowering agents\r\n\r\n               9. Willing to use an insulin approved for the pump (if assigned to HCL)\r\n\r\n              10. Willing to avoid medications containing acetaminophen, and no contraindications\r\n                  for ibuprofen use (in case assigned to Medtronic HCL system)\r\n\r\n          -  Participant Exclusion Criteria:\r\n\r\n               1. Ongoing use of medications known to influence glucose tolerance such as systemic\r\n                  steroids\r\n\r\n               2. Other systemic disease which in the opinion of the investigator precludes\r\n                  participation (including psychiatric illness)\r\n\r\n               3. Unwilling to abstain from use of HCL therapy for 12 months\r\n\r\n                  a. Personal pump and CGM use, including systems with a \"suspend-before-low\"\r\n                  function, will be allowed for participants randomized to non-HCL groups\r\n\r\n               4. \"Silent\" diabetes-i.e., Stage 3 diabetes that is identified by routine oral\r\n                  glucose tolerance testing (OGTT) or in the course of surveillance studies but is\r\n                  not accompanied by fasting hyperglycemia or classic symptoms of diabetes\r\n\r\n               5. Participation in another research study that involves diabetes care\r\n\r\n          -  Additional exclusion criteria for Cohort A:\r\n\r\n               1. Blood pressure (either systolic or diastolic) <5th percentile for age, gender,\r\n                  and height on two out of three measurements\r\n\r\n               2. Pulse <2nd percentile for age and gender on two out of three measurements\r\n\r\n               3. History of vasovagal syncopal episodes related to hypotension\r\n\r\n               4. Abnormal EKG rhythm unless cleared for study participation by a cardiologist\r\n\r\n               5. Underlying cardiac disease (ex. left ventricular dysfunction, hypertrophic\r\n                  cardiomyopathy), certain arrhythmias (ex. Atrioventricular block (AV) block,\r\n                  accessory pathway such as Wolff-Parkinson-White or Lown-Ganong-Levine syndromes),\r\n                  known liver dysfunction, known renal impairment, Duchenne's muscular dystrophy,\r\n                  active Graves disease or hyperthyroidism, and untreated hypothyroidism\r\n\r\n               6. Estimated glomerular filtration rate (eGFR) < 90\r\n\r\n               7. AST and/or ALT greater than 1.5 times the upper limit of normal\r\n\r\n               8. Need to use of any of the following medications during the study: beta blocker,\r\n                  seizure medication (carbamazepine, phenobarbital, phenytoin), other\r\n                  antihypertensive medications, HMG-CoA reductase inhibitors, lithium,\r\n                  theophylline, clonidine, or aspirin\r\n\r\n               9. Any known hypersensitivity reaction to Verapamil\r\n      ","sponsor":"Jaeb Center for Health Research","sponsor_type":"Other","conditions":"Type1 Diabetes","interventions":[{"intervention_type":"Device","name":"Device: HCL","description":"Hybrid Closed Loop therapy"},{"intervention_type":"Drug","name":"Drug: verapamil 120mg tablet","description":"verapamil tablet"},{"intervention_type":"Device","name":"Device: non-HCL","description":"Usual diabetes care"},{"intervention_type":"Drug","name":"Drug: placebo","description":"placebo pill manufactured to mimic verapamil 120mg tablet"}],"outcomes":[{"outcome_type":"primary","measure":"C-peptide","time_frame":"1 year","description":"The primary outcome is the C-peptide in response to a 2-hour MMTT at 52 weeks. This is measured as the area under the stimulated C-peptide curve (AUC). AUC is computed using a trapezoidal rule, which is a weighted sum of the C-peptide values over the 120 min."},{"outcome_type":"secondary","measure":"CGM Mean Glucose","time_frame":"1 year","description":"mean glucose between treatment groups"},{"outcome_type":"secondary","measure":"CGM coefficient of variation","time_frame":"1 year","description":"coefficient of variation between treatment groups"},{"outcome_type":"secondary","measure":"CGM time in range","time_frame":"1 year","description":"time 70-180 mg/dL between treatment groups"},{"outcome_type":"secondary","measure":"CGM time <70 mg/dL","time_frame":"1 year","description":"time <70 mg/dL between treatment groups"},{"outcome_type":"secondary","measure":"CGM time <54 mg/dL","time_frame":"1 year","description":"time <54 mg/dL between treatment groups"},{"outcome_type":"secondary","measure":"CGM time >180 mg/dL","time_frame":"1 year","description":"time >180 mg/dL between treatment groups"},{"outcome_type":"secondary","measure":"CGM time >250 mg/dL","time_frame":"1 year","description":"time >250 mg/dL between treatment groups"},{"outcome_type":"secondary","measure":"HbA1c","time_frame":"1 year","description":"HbA1c between treatment groups"},{"outcome_type":"secondary","measure":"Hypoglycemia","time_frame":"1 year","description":"Frequency of episodes of severe hypoglycemia between treatment groups"},{"outcome_type":"secondary","measure":"DKA","time_frame":"1 year","description":"Frequency of episodes of DKA between treatment groups"}]}
{"nct_id":"NCT04425733","start_date":"2020-07-07","phase":"Phase 1","enrollment":0,"brief_title":"MK-5475 in Participants With Hypoxemia Due to COVID-19 Pneumonia (MK-5475-009)","official_title":"A Study to Assess the Safety, Tolerability, and Pharmacodynamics of Multiple Dose MK-5475 in Participants With Hypoxemia Due to COVID-19 Pneumonia","primary_completion_date":"2020-11-10","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2020-11-10","last_update":"2020-08-14","description":"The purpose of this study is to evaluate safety, tolerability, and pharmacodynamics of MK-5475 after administration of multiple doses to participants with COVID-19 pneumonia. The primary hypothesis is that MK-5475 when administered to participants with COVID-19 pneumonia and hypoxemia improves arterial oxygenation as measured by the ratio of blood oxygen saturation to fraction of inspired oxygen (SpO2/FiO2 ratio) compared to placebo.","other_id":"5475-009","allocation":"Randomized","intervention_model":"Sequential Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Has virologically confirmed COVID-19 requiring hospital admission.\r\n\r\n          -  Has respiratory symptoms including cough and dyspnea\r\n\r\n          -  Requires supplemental oxygen therapy\r\n\r\n          -  Male participant is abstinent from heterosexual intercourse or agrees to use\r\n             contraception during the intervention period and for at least 14 days, corresponding\r\n             to time needed to eliminate study intervention(s) (example, 5 terminal half-lives\r\n             after the last dose of study intervention)\r\n\r\n          -  Female participant is not a woman of childbearing potential (WOCBP) or is a WOCBP who\r\n             is abstinent from heterosexual intercourse or using contraception during the\r\n             intervention period and for at least 14 days, corresponding to time needed to\r\n             eliminate study intervention(s) (example, 5 terminal half-lives after the last dose of\r\n             study intervention)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Has pre-existing medical conditions of any nature which are immediately pre-terminal\r\n             such as death or limitation of life-sustaining therapy is expected to be imminent\r\n\r\n          -  Requires or is expected to require invasive mechanical ventilation\r\n\r\n          -  Requires or is expected to require noninvasive mechanical ventilation\r\n\r\n          -  Has any issue which would prohibit them from effective use of the MK-5475 inhaler\r\n\r\n          -  Hypoxemia which is explained by any condition other than COVID-19, example,\r\n             preexisting cardiac or pulmonary disease\r\n\r\n          -  Has severe hepatic impairment (meets Child-Pugh Class C criteria)\r\n\r\n          -  Has severe renal impairment and/or requirement for renal dialysis\r\n      ","sponsor":"Merck Sharp & Dohme Corp.","sponsor_type":"Industry","conditions":"Coronavirus Disease 2019 (COVID-19)|Pneumonia|Hypoxemia","interventions":[{"intervention_type":"Drug","name":"Drug: MK-5475","description":"MK-5475 administered at a dose of 180 g or 360 g QD via inhalation"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"MK-5475-matching placebo administered QD via inhalation"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants Who Experience an Adverse Event (AE)","time_frame":"Up to ~Day 21","description":"An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported."},{"outcome_type":"primary","measure":"Number of Participants Who Discontinued Study Drug Due to an Adverse Event (AE)","time_frame":"Up to ~Day 7","description":"An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study drug due to an AE will be reported."},{"outcome_type":"primary","measure":"Change From Baseline to Day 1 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2)","time_frame":"Baseline, Day 1 (pre-dose and 2, 6, 12, 18, 24 hours post-dose)","description":"The SpO2/FiO2 ratio is a measure of arterial oxygenation. Noninvasive pulse oximetry will be used to obtain the SpO2/FiO2 ratio. The TWA0-24hrs will be calculated as the area under the curve from 0 to 24 hours post-dose on Day 1 divided by the length of time (24 hrs). Baseline is the Day 1 pre-dose measurement and assessments will be conducted pre-dose and at multiple time points post-dose on Day 1 to determine change from baseline in TWA0-24hrs for SpO2/FiO2 on Day 1."},{"outcome_type":"primary","measure":"Change From Baseline to Day 2 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2)","time_frame":"Baseline, Day 2 (pre-dose and 2, 6, 12, 18, 24 hours post-dose)","description":"The SpO2/FiO2 ratio is a measure of arterial oxygenation. Noninvasive pulse oximetry will be used to obtain the SpO2/FiO2 ratio. The TWA0-24hrs will be calculated as the area under the curve from 0 to 24 hours on Day 2 divided by the length of time (24 hrs). Baseline is the Day 1 pre-dose measurement and assessments will be conducted pre-dose and at multiple time points post-dose on Day 2 to determine change from baseline in TWA0-24hrs for SpO2/FiO2 on Day 2."},{"outcome_type":"primary","measure":"Change From Baseline to Day 3 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2)","time_frame":"Baseline, Day 3 (pre-dose and 2, 6, 12, 18, 24 hours post-dose)","description":"The SpO2/FiO2 ratio is a measure of arterial oxygenation. Noninvasive pulse oximetry will be used to obtain the SpO2/FiO2 ratio. The TWA0-24hrs will be calculated as the area under the curve from 0 to 24 hours on Day 3 divided by the length of time (24 hrs). Baseline is the Day 1 pre-dose measurement and assessments will be conducted pre-dose and at multiple time points post-dose on Day 3 to determine change from baseline in TWA0-24hrs for SpO2/FiO2 on Day 3."},{"outcome_type":"primary","measure":"Change From Baseline to Day 4 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2)","time_frame":"Baseline, Day 4 (pre-dose and 2, 6, 12, 18, 24 hours post-dose)","description":"The SpO2/FiO2 ratio is a measure of arterial oxygenation. Noninvasive pulse oximetry will be used to obtain the SpO2/FiO2 ratio. The TWA0-24hrs will be calculated as the area under the curve from 0 to 24 hours on Day 4 divided by the length of time (24 hrs). Baseline is the Day 1 pre-dose measurement and assessments will be conducted pre-dose and at multiple time points post-dose on Day 4 to determine change from baseline in TWA0-24hrs for SpO2/FiO2 on Day 4."},{"outcome_type":"primary","measure":"Change From Baseline to Day 5 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2)","time_frame":"Baseline, Day 5 (pre-dose and 2, 6, 12, 18, 24 hours post-dose)","description":"The SpO2/FiO2 ratio is a measure of arterial oxygenation. Noninvasive pulse oximetry will be used to obtain the SpO2/FiO2 ratio. The TWA0-24hrs will be calculated as the area under the curve from 0 to 24 hours on Day 5 divided by the length of time (24 hrs). Baseline is the Day 1 pre-dose measurement and assessments will be conducted pre-dose and at multiple time points post-dose on Day 5 to determine change from baseline in TWA0-24hrs for SpO2/FiO2 on Day 5."},{"outcome_type":"primary","measure":"Change From Baseline to Day 6 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2)","time_frame":"Baseline, Day 6 (pre-dose and 2, 6, 12, 18, 24 hours post-dose)","description":"The SpO2/FiO2 ratio is a measure of arterial oxygenation. Noninvasive pulse oximetry will be used to obtain the SpO2/FiO2 ratio. The TWA0-24hrs will be calculated as the area under the curve from 0 to 24 hours on Day 6 divided by the length of time (24 hrs). Baseline is the Day 1 pre-dose measurement and assessments will be conducted pre-dose and at multiple time points post-dose on Day 6 to determine change from baseline in TWA0-24hrs for SpO2/FiO2 on Day 6."},{"outcome_type":"primary","measure":"Change From Baseline to Day 7 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2)","time_frame":"Baseline, Day 7 (pre-dose and 2, 6, 12, 18, 24 hours post-dose)","description":"The SpO2/FiO2 ratio is a measure of arterial oxygenation. Noninvasive pulse oximetry will be used to obtain the SpO2/FiO2 ratio. The TWA0-24hrs will be calculated as the area under the curve from 0 to 24 hours on Day 7 divided by the length of time (24 hrs). Baseline is the Day 1 pre-dose measurement and assessments will be conducted pre-dose and at multiple time points post-dose on Day 7 to determine change from baseline in TWA0-24hrs for SpO2/FiO2 on Day 7."}]}
{"nct_id":"NCT04495491","start_date":"2020-07-01","enrollment":200,"brief_title":"Predicting the Effect of Laser Peripheral Iridotomy","official_title":"Prediction of the Degree of Angle Opening Distance in Patients With Primary Angle Closure Suspect After Laser Peripheral Iridotomy","primary_completion_date":"2020-12-31","study_type":"Observational [Patient Registry]","rec_status":"Recruiting","completion_date":"2021-03-31","last_update":"2020-07-31","description":"This study will compare the angle parameters of patients with PACS before and after LPI. The investigators will analyze the results of patients with different angle closure mechanisms before and after LPI, and participants hope to find the structural parameters for predicting the effect of LPI.","other_id":"2019KYPJ182","observational_model":"Other","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":20,"population":"Chinese Patient was diagnosed of primary angle closure angle suspect","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patient was diagnosed of primary angle closure angle suspect;\r\n\r\n          2. received ultrasound Biomicroscopy before and after laser peripheral iridotomy;\r\n\r\n          3. Voluntary participation in this study;\r\n\r\n          4. Have enough language comprehension ability;\r\n\r\n          5. Patient or his legal representative has sign the informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. severe health problems resulting in a life expectancy of less than 1 year;\r\n\r\n          2. previous intraocular surgery or penetrating eye injury;\r\n\r\n          3. media opacity preventing laser peripheral iridotomy;\r\n\r\n          4. Researchers think not suitable to participate in this clinical trial subjects;\r\n\r\n          5. Refused to sign the informed consent.;\r\n\r\n          6. There are important viscera function failure or other serious disease, including\r\n             clinical related coronary artery disease, cardiovascular disease or myocardial\r\n             infarction into the group of the first six months; serious neurological or psychiatric\r\n             illness; serious infections; coagulant function abnormality; general active infectious\r\n             diseases; malignant tumor; serious immune diseases.\r\n      ","sponsor":"Zhongshan Ophthalmic Center, Sun Yat-sen University","sponsor_type":"Other","conditions":"Glaucoma","interventions":[{"intervention_type":"Other","name":"Other: pupillary block group","description":"According to the configurations of angle closure, the pupillary block group is defined as the iris bombe."},{"intervention_type":"Other","name":"Other: plateau iris group","description":"According to the configurations of angle closure, the plateau iris group is defined as the thickness of the peripheral iris."},{"intervention_type":"Other","name":"Other: mixing mechanism group","description":"According to the configurations of angle closure, the mixing mechanism group is defined as the iris bombe plus thickening of the peripheral iris."}],"outcomes":[{"outcome_type":"primary","measure":"the changes in anterior opening distance before and after LPI","time_frame":"between the baseline and 1 hour before discharge","description":"To compare the difference of anterior opening distance after LPI and baseline parameters before LPI. Anterior opening distance, measured on a line perpendicular to the plane of the trabecular surface 500 μm anterior to the scleral spur and extended to meet the surface of the iris"}]}
{"nct_id":"NCT04466176","start_date":"2020-07-01","phase":"Phase 1","enrollment":34,"brief_title":"A Pivotal Bioequivalence Study Between Fluticasone Propionate 250 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS 250/50 Inhalation Powder/GSK in Healthy Volunteers","official_title":"A Pivotal, Randomized, Single-dose, Open Label, Two-treatment, Two-sequence, Two-period, Crossover Study Under Fasting Conditions to Examine the Bioequivalence Between Fluticasone Propionate 250 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS 250/50 Inhalation Powder/GSK in Healthy Volunteers","primary_completion_date":"2020-08-04","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-12-31","last_update":"2021-03-09","description":"Bioequivalence study between two inhaler products of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder","other_id":"BECRO/RESP/BE250-PIVOTAL","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Other","masking_description":"Single","intervention_model_description":"One-center crossover, randomized, 2-period, 2-sequence (RT and TR), single dose, laboratory-blinded study","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Healthy volunteers of both genders, aged 18 and 60 years.\r\n\r\n          2. Subjects with Body Mass Index () 18.5 and <30.0 kg/m2.\r\n\r\n          3. Healthy volunteers are declared healthy based on medical history, physical\r\n             examination, ECG, pulmonary function test (a forced expiratory volume in 1 second\r\n             (FEV1) 80% of the predicted normal value), and clinical laboratory values within the\r\n             laboratory stated normal range; if not within this range, they must be without any\r\n             clinical significance according to the Investigator.\r\n\r\n          4. Females who participate in the study are either at reproductive age i.e.pre-menopausal\r\n             or unable to gestate [i.e. post-menopausal (absence of menses for 12 months prior to\r\n             drug administration), hysterectomy, bilateral oophorectomy, tubal ligation at least 6\r\n             months prior to drug administration].\r\n\r\n          5. Subjects that are non-smokers.\r\n\r\n          6. Subjects that, in the opinion of the principal investigator/medical officer, are able\r\n             to communicate and comply with the study procedures and protocol restrictions as\r\n             evidenced by the Informed Consent Form (ICF) duly read, signed and dated by the\r\n             subject prior to study initiation.\r\n\r\n          7. Subjects able to use the inhalers according to given instructions, as judged by the\r\n             Investigator or study nurse.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Hypersensitivity to the active substance(s) or to the excipient (lactose which\r\n             contains small amounts of milk protein may cause allergic reactions) or related class\r\n             (any sympathomimetic drug or any inhaled, intranasal, or systemic corticosteroid\r\n             therapy) of the medicinal product\r\n\r\n          2. Clinically significant illness or surgery within four weeks prior to dosing.\r\n\r\n          3. Clinically significant ECG abnormalities or vital sign abnormalities (seated systolic\r\n             blood pressure <90 or >140 mmHg, seated diastolic blood pressure <50 or >90 mmHg or\r\n             heart rate less than 50 or over 100 bpm) at screening.\r\n\r\n          4. Clinically significant history or presence of chronic bronchitis, emphysema,asthma or\r\n             any other lung disease.\r\n\r\n          5. History or presence of pulmonary tuberculosis.\r\n\r\n          6. Viral or bacterial, upper or lower respiratory tract infection or sinus or middle ear\r\n             infection within 4 weeks prior to the screening visit.\r\n\r\n          7. History or presence of significant cardiovascular, endocrinal, neurologic,\r\n             immunological, psychiatric or metabolic disease.\r\n\r\n          8. History of significant alcohol or drug abuse within one year prior to the screening\r\n             visit.\r\n\r\n          9. Regular use of alcohol within six months prior to screening visit (more than 14\r\n             alcohol units per week) [1Unit =150 ml of wine, 360 ml of beer, or 45 ml of 40%\r\n             alcohol].\r\n\r\n         10. Inability to abstain from alcohol for the duration of study period.\r\n\r\n         11. Presence of disease markers for Hepatitis B, Hepatitis C or HIV at screening.\r\n\r\n         12. Positive results for drugs of abuse (barbiturates, marijuana, opioids, benzodiazepines\r\n             and methadone) in saliva before each administration.\r\n\r\n         13. Positive alcohol breath test before each administration.\r\n\r\n         14. Use of soft drugs (such as marijuana) within three months prior to screening or hard\r\n             drugs such as crack, cocaine or heroin within one year prior to screening visit\r\n\r\n         15. Intake of any drugs known to induce or inhibit hepatic drug metabolism (examples of\r\n             inducers are barbiturates, carbamazepine, phenytoin, glucocorticoids,\r\n             rifampin/rifabutin; examples of inhibitors are, erythromycin, ketoconazole, indinavir,\r\n             cobicistat-containing products) within one month prior to administration of the study\r\n             medication. Under these circumstances, subject inclusion will be judged by the\r\n             principal investigator.\r\n\r\n         16. History of peptic ulcer, other gastrointestinal disorders (e.g. chronic diarrhoea,\r\n             irritable bowel syndrome) or unresolved gastrointestinal symptoms (e.g. diarrhea,\r\n             vomiting) or significant hepatic, renal or other condition that is known to interfere\r\n             with the absorption, distribution, metabolism or excretion of the drug.\r\n\r\n         17. Use of oral or parenteral corticosteroids in the previous four 4 weeks\r\n\r\n         18. Eye disorders especially Glaucoma (or a family history of glaucoma)\r\n\r\n         19. Use of prescription medication (within 14 days prior to the first administration of\r\n             study medication) or over-the-counter (OTC) products (including food supplements\r\n             vitamins and herbal supplements) within one week (7 days) prior to the first\r\n             administration of study medication, except for topical products without systematic\r\n             absorption. Contraceptives are allowed.\r\n\r\n         20. Vaccination for prophylaxis from seasonal flu or any other vaccination within seven\r\n             days prior to administration\r\n\r\n         21. History of allergy to any food, intolerance or special diet, that in the opinion of\r\n             the medical sub-investigator could contraindicate the subject's participation in the\r\n             study.\r\n\r\n         22. A depot injection or an implant of any drug (except hormonal contraceptives) within 3\r\n             months prior to treatment administration.\r\n\r\n         23. Donation of plasma (500 ml) within 7 days prior to treatment administration.\r\n\r\n         24. Donation of whole blood or loss of whole blood  500 ml prior to administration of the\r\n             study medication within 30 days prior to treatment administration.\r\n\r\n         25. Participation in another clinical trial simultaneously.\r\n\r\n         26. Subjects receiving special diet or having intolerance in any of the provided study\r\n             meals or refusing to eat the study meals\r\n\r\n         27. Application of tattoo or body piercing within 30 days prior to treatment\r\n             administration.\r\n\r\n         28. Non-tolerance to venipuncture.\r\n\r\n         29. Breastfeeding women.\r\n\r\n         30. Positive pregnancy test at screening\r\n\r\n         31. Females of reproductive age that had sexual intercourse with a non-sterile male\r\n             partner without protection within 14 days prior to drug administration\r\n\r\n        Reliable contraception methods are considered the following:\r\n\r\n          -  combined (estrogen and progestogen containing) hormonal contraception associated with\r\n             inhibition of ovulation: oral, intravaginal or transdermal\r\n\r\n          -  progestogen-only hormonal contraception associated with inhibition of ovulation oral,\r\n             implanable or injectable\r\n\r\n          -  intrauterine device (IUD)\r\n\r\n          -  intrauterine hormone-releasing system (IUS)\r\n\r\n          -  bilateral tubal occlusion\r\n\r\n          -  vasectomised partner\r\n\r\n          -  sexual abstinence\r\n      ","sponsor":"Respirent Pharmaceuticals Co Ltd.","sponsor_type":"Industry","conditions":"Bioequivalence","interventions":[{"intervention_type":"Drug","name":"Drug: Test Product","description":"2 inhalations of Test and Reference product in each study period"},{"intervention_type":"Drug","name":"Drug: Reference Product","description":"2 inhalations of Test and Reference product in each study period"}],"outcomes":[{"outcome_type":"primary","measure":"Cmax","time_frame":"up to 36 hours post-administration","description":"Maximum plasma concentration, it is read directly from the raw data"},{"outcome_type":"primary","measure":"AUC(0-t)","time_frame":"up to 36 hours post-administration","description":"Area under the plasma concentration curve from time 0 to the last measured"},{"outcome_type":"secondary","measure":"AUC0-∞","time_frame":"up to 36 hours post-administration","description":"Area under the plasma concentration-time curve extrapolated to infinity"},{"outcome_type":"secondary","measure":"Tmax","time_frame":"up to 36 hours post-administration","description":"Time until Cmax is reached, it is read directly from the observed concentrations"},{"outcome_type":"secondary","measure":"t1/2","time_frame":"up to 36 hours post-administration","description":"Plasma concentration halflife, it is calculated from the ratio 0.693/λZ"},{"outcome_type":"secondary","measure":"λz","time_frame":"up to 36 hours post-administration","description":"Terminal elimination rate constant, calculated from the slope of the final phase of the ln-concentration curve versus time with regression analysis"},{"outcome_type":"secondary","measure":"Residual area","time_frame":"up to 36 hours post-administration","description":"[AUC(0-∞)-AUC(0-t)]/AUC(0-∞)]"}]}
{"nct_id":"NCT04407650","start_date":"2020-07-01","phase":"Phase 4","enrollment":158,"brief_title":"Ursodeoxycholic Acid vs Metformin in Gestational Diabetes Mellitus","official_title":"Randomised Controlled Trial of Gestational Treatment With Ursodeoxycholic Acid Compared to Metformin to Reduce Effects of Diabetes Mellitus","primary_completion_date":"2022-01-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2022-06-30","last_update":"2020-05-29","description":"GUARD is a Clinical Trial that wants to explore the impact of UDCA compared to metformin in the treatment of GDM. The trial wants to recruit 158 women who are overweight or obese who have been diagnosed with GDM, and require pharmacological treatment. Glucose control is our primary measure. Each year in the UK approximately 35,000 women develop diabetes during pregnancy, a condition called gestational diabetes mellitus (GDM), which increases the risk of adverse outcomes for both mother and child. Metformin, although unlicensed for used in pregnancy, is the most commonly used first line pharmacological treatment. However, there is increasing concern about its widespread use during pregnancy, because of its limited efficacy and because of potential safety concerns. Other common treatments have not been shown to be superior. Therefore, there is an unmet need for additional therapies. Ursodeoxycholic acid (UDCA) is commonly used in pregnancy for the treatment of intrahepatic cholestasis of pregnancy. It is currently not an established/licensed treatment for GDM. However data from observational studies of women with cholestasis in pregnancy has flagged this to be a potential effective treatment to control blood glucose levels in GDM. The investigators will ask women to attend three study visits, which will coincide with the time of their antenatal appointments. The trial aims to collect a range of clinical and research blood samples, to measure quality of life and treatment satisfaction through two questionnaires, and will will ask women to wear a continuous glucose monitor for three 10 day periods. There will be a number of optional assessments that participants will be offered. The primary outcome will be the fasting blood glucose concentration at 36 weeks of gestation. The investigators intend to carry out this study at 3 sites in the United Kingdom (Guy's and St Thomas, Imperial College and Nottingham), and it has been funded by a J.P Moulton Foundation grant.","other_id":"264693","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Pilot Phase 4 Randomised Controlled Trial","sampling_method":"","gender":"Female","minimum_age":16,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Women between 16 and 45 years of age with GDM diagnosed at 26+0 to 30+6 weeks'\r\n             gestation in accordance with the NICE guidelines (one or more glucose concentrations\r\n             of 5.6 mmol/l fasting or 7.8 mmol/l 2 hours after a standard 75g OGTT, and requiring\r\n             pharmacological treatment).\r\n\r\n          2. Overweight or obese (Booking BMI 25 kg/m2)\r\n\r\n          3. Planned antenatal, intrapartum and postpartum care at the participating centre (i.e.\r\n             not planning to move before delivery).\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Unwilling/unable to give written informed consent and comply with the requirements of\r\n             the study protocol\r\n\r\n          2. Multiple pregnancies (twins, triplets etc) in current pregnancy\r\n\r\n          3. Congenital anomaly on ultrasound requiring fetal medicine input\r\n\r\n          4. Previous diagnosis of diabetes outside pregnancy\r\n\r\n          5. HbA1c at booking >48 mmol/mol or 6.5% during current pregnancy (if available)\r\n\r\n          6. Significant pre-pregnancy comorbidities that increase risk in pregnancy, for example\r\n             renal failure, severe liver disease, transplantation, cardiac failure, psychiatric\r\n             conditions requiring in-patient admission (within previous year) in the opinion of the\r\n             responsible clinician or the CI.\r\n\r\n          7. Significant co-morbidity in the current pregnancy, nephropathy (estimated GFR\r\n             <60ml/min), other physical or psychological conditions likely to interfere with the\r\n             conduct of the study and/or interpretation of the trial results in the opinion of the\r\n             responsible clinician or the CI.\r\n\r\n          8. Not fluent in English and absence of interpreter or translation services (ie telephone\r\n             translation services)\r\n\r\n          9. Participating in another intervention study where the results could influence\r\n             GDM-related endpoints, in the opinion of the responsible clinician or the CI, or\r\n             participation in a CTIMP during current pregnancy.\r\n\r\n         10. Known allergy/hypersensitivity/intolerance to the active substance or excipients, or\r\n             patients taking any medications which are contraindicated as per IMP SmPC\r\n      ","sponsor":"King's College London","sponsor_type":"Other","conditions":"Gestational Diabetes","interventions":[{"intervention_type":"Drug","name":"Drug: Metformin","description":"Patients will be randomized to each intervention using minimisation:\r\nBMI category (Overweight/Obese),\r\nPrevious history of GDM,\r\nDisease severity (baseline fasting glucose 6.2 or >6.2),\r\nRecruitment centre"},{"intervention_type":"Drug","name":"Drug: Ursodeoxycholic Acid","description":"Patients will be randomized to each intervention using minimisation:\r\nBMI category (Overweight/Obese),\r\nPrevious history of GDM,\r\nDisease severity (baseline fasting glucose 6.2 or >6.2),\r\nRecruitment centre"}],"outcomes":[{"outcome_type":"primary","measure":"Glycaemic control","time_frame":"Gestational week 36","description":"Maternal fasting glucose concentration in blood sample"},{"outcome_type":"secondary","measure":"Acceptability","time_frame":"Gestational week 36","description":"To assess the acceptability of UDCA compared to metformin using the Diabetes Treatment Satisfaction Questionnaire GB-DTSQs_Jul94 with scales ranging from 6 (increased satisfaction/acceptability) - 0 (dissatisfaction)"},{"outcome_type":"secondary","measure":"Biomedical outcomes: continuous glucose monitoring","time_frame":"Baseline (week 28), Follow up 1 (week 32), Follow up 2 (week 36)","description":"Glucose metabolism control measured by continuous glucose monitors to establish whether continuous glucose monitoring gives more informative overall assessment of maternal glycaemic control"},{"outcome_type":"secondary","measure":"Biomedical outcomes: 1,5-anhydroglucitol","time_frame":"Baseline (week 28), Follow up 1 (week 32), Follow up 2 (week 36)","description":"Glucose metabolism control measured by serum concentrations of 1,5-anhydroglucitol"},{"outcome_type":"secondary","measure":"Biomedical outcomes: glucose control by HbA1c","time_frame":"Baseline (week 28), Follow up 2 (week 36)","description":"Glucose metabolism control measured by HbA1c concentration"},{"outcome_type":"secondary","measure":"Biomedical outcomes: lipids","time_frame":"Follow up 2 (week 36)","description":"Lipid metabolism assessed by blood triglyceride, total cholesterol, calculated LDL-cholesterol, HDL-cholesterol and free fatty acid concentrations, all in mmol/L"},{"outcome_type":"secondary","measure":"Biomedical analyses: bilirubin","time_frame":"Follow up 2 (week 36)","description":"Maternal liver function tests: bilirubin"},{"outcome_type":"secondary","measure":"Biomedical analyses: ALT","time_frame":"Follow up 2 (week 36)","description":"Maternal liver function tests: ALT"},{"outcome_type":"secondary","measure":"Biomedical analyses: bile acids","time_frame":"Follow up 2 (week 36)","description":"Maternal liver function tests: bile acids"},{"outcome_type":"secondary","measure":"Biomedical analyses: CRP","time_frame":"Follow up 2 (week 36)","description":"Maternal liver function tests: C reactive protein"},{"outcome_type":"secondary","measure":"Clinical maternal outcomes: insulin","time_frame":"From enrolment to birth","description":"Proportion of women requiring insulin treatment (time until treatment and dose)"},{"outcome_type":"secondary","measure":"Clinical maternal outcomes: weight","time_frame":"Follow up 2 (week 36) compared to first trimester","description":"Maternal weight change"},{"outcome_type":"secondary","measure":"Maternal vascular responses (I)","time_frame":"Follow up 1 (week 32), Follow up 2 (week 36)","description":"maternal pulse wave velocity (PWV)"},{"outcome_type":"secondary","measure":"Maternal vascular responses (II)","time_frame":"Follow up 1 (week 32), Follow up 2 (week 36)","description":"systolic and diastolic blood pressure"},{"outcome_type":"secondary","measure":"Maternal vascular responses (III)","time_frame":"Follow up 1 (week 32), Follow up 2 (week 36)","description":"central arterial pressure (cP)"},{"outcome_type":"secondary","measure":"Maternal vascular responses (IV)","time_frame":"Follow up 1 (week 32), Follow up 2 (week 36)","description":"ugmentation index (AIx)"},{"outcome_type":"secondary","measure":"Blood loss","time_frame":"Delivery","description":"Estimated blood loss during birth"},{"outcome_type":"secondary","measure":"Neonatal outcomes: mode of birth","time_frame":"Delivery","description":"Amongts all participants, caesarean section (elective & emergency), assisted vaginal birth and spontaneous vaginal delivery numbers will be measured"},{"outcome_type":"secondary","measure":"Neonatal outcomes: gestational age","time_frame":"Delivery","description":"Gestational age at birth"},{"outcome_type":"secondary","measure":"Neonatal outcomes: apgar scores","time_frame":"Delivery","description":"Apgar scores at 5 minutes post birth"},{"outcome_type":"secondary","measure":"Neonatal outcomes: shoulder dystocia","time_frame":"Delivery","description":"Occurrence of shoulder dystocia"},{"outcome_type":"secondary","measure":"Neonatal outcomes: weight","time_frame":"Delivery","description":"Infant birth weight will be collected to analyse the percentage proportion of babies born large for gestational age and proportion of babies born small for gestational age"},{"outcome_type":"secondary","measure":"Neonatal outcomes: morbidity","time_frame":"Delivery","description":"Treatment for neonatal hypoglycaemia, neonatal jaundice, respiratory distress or birth trauma"},{"outcome_type":"secondary","measure":"Neonatal outcomes: rate of special care unit admission.","time_frame":"28 days post delivery","description":"Neonatal intensive care and special care unit admission (duration of hospital stay)"},{"outcome_type":"secondary","measure":"Stillbirth and neonatal death","time_frame":"Delivery","description":"Occurrence of stillbirth and neonatal death"},{"outcome_type":"secondary","measure":"Biomedical neonatal outcomes","time_frame":"Delivery","description":"Cord blood C-peptide, triglyceride, total cholesterol, calculated LDL-cholesterol, HDL-cholesterol and free fatty acid concentrations all in mmol/L"}]}
{"nct_id":"NCT04411719","start_date":"2020-07-01","phase":"N/A","enrollment":60,"brief_title":"Oscillatory Electric Stimulation in Patients With Disorders of Consciousness","official_title":"The Usage of TNS in Patients With Disorders of Consciousness","primary_completion_date":"2021-04-01","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2021-08-01","last_update":"2020-06-16","description":"Altered gamma has been observed in several neurological and psychiatric disorders, including a reduction in gamma synchronization in patients with disorders of consciousness. Modulation of gamma oscillations with rhythmic stimulation has been used as a possible therapeutic tool. Hence, we try to use 40Hz electric stimulation to restore brain oscillation and thereby to improve conscious awareness in patients with disorders of consciousness.","other_id":"TNS","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Disorders of consciousness; 4 weeks post-injury; No epilepsy or frequent spontaneous\r\n        movement.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Any contraindication to electric stimulation (e.g., intracranial metal devices,\r\n        pacemakers); Not medically stable.\r\n      ","sponsor":"First Affiliated Hospital of Zhejiang University","sponsor_type":"Other","conditions":"Consciousness Disorder|Electric Stimulation","interventions":[{"intervention_type":"Device","name":"Device: Electric stimulation device(Neuroconn)","description":"Real electric stimulation"}],"outcomes":[{"outcome_type":"primary","measure":"Coma Recovery Scale-Revised scores","time_frame":"15 days","description":"CRS-R is used to assess the consciousness level."},{"outcome_type":"secondary","measure":"Neuropsychological assessment","time_frame":"15 days","description":"EEG indicators(i.e.,gamma oscillation, event-related potentials) are used to assess the consciousness level."}]}
{"nct_id":"NCT04949204","start_date":"2020-07-01","enrollment":50,"brief_title":"Context-awareness, Physiological Monitoring, and Machine Learning in Migraine and Cluster Headache","official_title":"Contextuele Analyse, Fysiologische Metingen en Machinaal Leren Voor Migraine en Clusterhoofdpijn (COPIMAC Studie)","primary_completion_date":"2021-07-01","study_type":"Observational","rec_status":"Recruiting","completion_date":"2021-08-01","last_update":"2021-07-02","description":"This is an observational, longitudinal cohort pilot study measuring physiological signals through wearable sensors combined with machine learning algorithms to detect behaviour, stress and headaches in patients with migraine and cluster headache.","other_id":"BC-07403","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":65,"population":"Migraine or cluster headache patients","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  migraine or cluster headache diagnosis based on ICHD 3 criteria\r\n\r\n          -  at least 2 attacks each month\r\n\r\n          -  onset of headache syndrome before the age of 50\r\n\r\n          -  if multiple headache syndromes coexist: attacks are clearly distinguishable\r\n\r\n          -  participant has smartphone that he/she wants to apply for this research\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  chronic migraine patients\r\n\r\n          -  history of alcohol or illicit drug abuse\r\n\r\n          -  significant medical comorbidity deemed by the investigator to interfere with the study\r\n\r\n          -  use of betablockers\r\n\r\n          -  participating in other academic or commercial trials\r\n      ","sponsor":"University Hospital, Ghent","sponsor_type":"Other","conditions":"Migraine|Cluster Headache","interventions":[{"intervention_type":"Procedure","name":"Procedure: Wearable sensor detection","description":"Empatica E4 wearable wrist sensor"}],"outcomes":[{"outcome_type":"other","measure":"SF20","time_frame":"21 days","description":"In migraine and cluster headache patients"},{"outcome_type":"primary","measure":"Galvanic Skin Response changes","time_frame":"21 days","description":"Changes in GSR through the different phases of the headache attacks"},{"outcome_type":"secondary","measure":"Activity ratio","time_frame":"21 days","description":"Activity ratio measurement through accelerometer data"},{"outcome_type":"secondary","measure":"Skin temperature","time_frame":"21 days","description":"Skin temperature measurement through builtin thermometer"},{"outcome_type":"other","measure":"Prevalence of premonitory symptoms","time_frame":"21 days"},{"outcome_type":"other","measure":"Prevalence of cranial autonomic symptoms","time_frame":"21 days"},{"outcome_type":"other","measure":"Prevalence of postdromal symptoms","time_frame":"21 days"},{"outcome_type":"other","measure":"MSQv2.1 questionnaire","time_frame":"21 days","description":"In migraine patients"},{"outcome_type":"other","measure":"MIDAS questionnaire","time_frame":"21 days","description":"In migraine patients"}]}
{"nct_id":"NCT04438798","start_date":"2020-07-01","phase":"N/A","enrollment":80,"brief_title":"High Flow Nasal Cannula to Prevent Deoxygenation During Induction of General Anesthesia in Cesarean Section","official_title":"A Prospective Randomized Study of High Flow Nasal Cannula to Prevent Deoxygenation During Induction of General Anesthesia in Cesarean Section","primary_completion_date":"2020-10-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2020-11-01","last_update":"2020-08-18","description":"Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) using high flow oxygen therapy for preoxygenation and oxygen supplementation during apnoea has shown promising results","other_id":"0304665","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Diagnostic","masking_description":"Single","sampling_method":"","gender":"Female","minimum_age":20,"maximum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  pregnant females\r\n\r\n          -  Of American Society of Anesthesiologists (ASA) physical Status I and II\r\n\r\n          -  For elective cesarean section under general anesthesia\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  with room air saturation of <98%\r\n\r\n          -  anticipated difficult airway\r\n\r\n          -  anticipated obstetric risk factor or precious baby\r\n\r\n          -  chronic obstructive pulmonary disease\r\n\r\n          -  thyrotoxicosis\r\n\r\n          -  pheochromocytoma\r\n\r\n          -  hyperkalaemia\r\n\r\n          -  significant cardiac illness\r\n      ","sponsor":"Alexandria University","sponsor_type":"Other","conditions":"Hypoxic Brain Injury|Maternal Death","interventions":[{"intervention_type":"Other","name":"Other: F Group","description":"In Group F, pregnant females will be preoxygenated with 100% oxygen using a tight-fitting face mask at a rate of 6 L/min for 3 min with end-tidal gas monitoring."},{"intervention_type":"Other","name":"Other: H Group","description":"In Group H, high-flow humidified oxygen warmed to 37C will be delivered through nasal cannula at the rate of 30 L/ min for 30 seconds then 50 liters per minute for a further 150 seconds."}],"outcomes":[{"outcome_type":"primary","measure":"measure the time of safe apnea","time_frame":"10 minutes after induction","description":"The apnea time will start from the onset of cessation of breathing as evidenced by a flat line in the capnogram with the absence of chest movements"}]}
{"nct_id":"NCT04443205","start_date":"2020-06-30","enrollment":3000,"brief_title":"Relevance of Ultrasound Screening for Foetal Macrosomia","official_title":"Relevance of Ultrasound Screening for Foetal Macrosomia and Description of Its Management in Champagne-Ardenne","primary_completion_date":"2021-09-30","study_type":"Observational","rec_status":"Not yet recruiting","completion_date":"2021-12-31","last_update":"2020-06-23","description":"Management of fetal macrosomia is based on a suspicion of macrosomia (no certainty before birth). This management is an artificial induction of labour for an earlier delivery and therefore a lower fetal weight gain. Several studies have already shown that ultrasound performed during the third trimester of pregnancy was not a perfect tool for this screening.","other_id":"PO20090","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"Female","population":"Pregnant women","criteria":"\n        Inclusion criteria : Patients (consecutive inclusions) :\r\n\r\n        Women pregnant Women followed in the gynaecology and obstetrics department of the CHU of\r\n        Reims, the CHG of Charleville Mzires or the CHG of Chalons en Champagne.\r\n\r\n        Women for which the delivery is planned in the gynaecology and obstetrics department of the\r\n        Reims University Hospital, the Charleville Mzires General Hospital or the Chalons en\r\n        Champagne General Hospital.\r\n\r\n        Non-inclusion criteria Women without ultrasound dating scan in the first trimester. Women\r\n        having a contraindication to labour or vaginal delivery Women with a scarred uterus Women\r\n        having a history of shoulder dystocia or obstetric trauma Women having a history of urinary\r\n        or fecal incontinence Women having a history of bad birth experience with high\r\n        psychological impact Women with maternal pathologies (excluding gestational diabetes) Women\r\n        whose fetus is breech Women with twin pregnancy\r\n      ","sponsor":"CHU de Reims","sponsor_type":"Other","conditions":"Pregnancy","interventions":[{"intervention_type":"Other","name":"Other: Data record","description":"Data record"}],"outcomes":[{"outcome_type":"primary","measure":"Foetal macrosomia","time_frame":"Baseline","description":"estimated weight above the 90th percentile of the curves of the French College of Fetal Ultrasound during the third trimester ultrasound"}]}
{"nct_id":"NCT04419701","start_date":"2020-06-30","phase":"N/A","enrollment":88,"brief_title":"Comparison of Ultrasound Guided Genicular Nerve Block and Periarticular Infiltration in Knee Arthroplasty","official_title":"Comparison of Ultrasound Guided Genicular Nerve Block and Periarticular Infiltration for Postoperative Pain in Knee Arthroplasty","primary_completion_date":"2020-12-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2021-01-15","last_update":"2021-02-17","description":"Effective pain relief allows the patients to obtain early knee mobilization and optimal rehabilitation and thus improves the patient satisfaction. The aim of perioperative pain control is to minimize delays in recovery, postoperative delirium and pain-related stress responses that can lead to serious morbidity and poor outcomes. Numerous approaches to effectively control postoperative pain in TKA patients have been evaluated, as poorly controlled acute postoperative pain can be associated with persistent pain. Furthermore, increased pain intensity after surgery on the second knee seems to be closely associated with chronic post-TKA pain, with similar mechanisms underlying hyperalgesia or chronic pain.","other_id":"pain in knee arthroplasty","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  unilateral knee arthroplasty surgery,\r\n\r\n          -  aged more than 50 years of both genders.\r\n\r\n          -  have american society of anesthesiologist physical status I-II and III.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Revision knee arthroplasty,\r\n\r\n          -  previous surgery or trauma to knee,\r\n\r\n          -  drug allergy, regular narcotic use,\r\n\r\n          -  renal impairments\r\n\r\n          -  hepatic impairments,\r\n\r\n          -  neuromuscular diseases\r\n\r\n          -  coagulopathy disorders.\r\n      ","sponsor":"Tanta University","sponsor_type":"Other","conditions":"Postoperative Pain","interventions":[{"intervention_type":"Procedure","name":"Procedure: periarticular infiltration","description":"The cocktail will be injected at the following 7 anatomical zones as follows:\r\nZone 1: medial retinaculum Zone 2: medial collateral ligament and medial meniscus capsular attachment Zone 3: posterior capsule Zone 4: lateral collateral ligament and lateral meniscus capsular attachment Zone 5: lateral retinaculum Zone 6: patellar tendon and fat pad Zone 7: cut ends of quadriceps muscle and tendon Injection at zones 2, 3, and 4 will be administered after making the tibial and femoral cuts and ligament balancing. At zones 1, 5, 6, and 7, the injection will be administered after implant placement."},{"intervention_type":"Procedure","name":"Procedure: genicular nerve block","description":"The genicular arteries will be identified near the periosteal areas, which are the junctions of the epicondyle and the shafts of the femur and tibia, and confirmed by color Doppler ultrasound. genicular nerve block target points should be next to each genicular artery because the superior lateral, superior medial, and inferior medial genicular artery traveled along each genicular nerve.After using color Doppler to confirm the genicular artery, the needle will be inserted in the plane of the ultrasound probe in the long-axis view."}],"outcomes":[{"outcome_type":"primary","measure":"total doses of postoperative opioid consumption","time_frame":"postoperative first day","description":"total doses of postoperative rescue morphine consumption"},{"outcome_type":"secondary","measure":"Time of the first dose of rescue analgesia","time_frame":"postoperative first day","description":"Time of the first dose of rescue morphine analgesia at dose of 3 mg"},{"outcome_type":"other","measure":"Knee range of motion","time_frame":"postoperative first day","description":"The knee primarily only moves in one plane of movement, flexion and extension. A completely straight knee joint will measure 0° and a fully bent knee will have a flexion of at 135° degrees"},{"outcome_type":"other","measure":"Knee range of motion","time_frame":"postoperative second day","description":"The knee primarily only moves in one plane of movement, flexion and extension. A completely straight knee joint will measure 0° and a fully bent knee will have a flexion of at 135° degrees"},{"outcome_type":"other","measure":"Knee range of motion","time_frame":"postoperative third day","description":"The knee primarily only moves in one plane of movement, flexion and extension. A completely straight knee joint will measure 0° and a fully bent knee will have a flexion of at 135° degrees"}]}
{"nct_id":"NCT04379895","start_date":"2020-06-30","phase":"N/A","enrollment":60,"brief_title":"Comparison of Heated vs. Pulsed Radiofrequency Treatment of the Genicular Nerves for Osteoarthritis Knee Pain","official_title":"Comparison of Heated vs. Pulsed Radiofrequency Treatment of the Genicular Nerves for Osteoarthritis Knee Pain","primary_completion_date":"2022-06-30","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2022-08-31","last_update":"2020-05-13","description":"This is a prospective, randomised, interventional, double blinded study to compare the clinical outcomes of thermal vs. pulsed radiofrequency (RF) treatment of the genicular nerves in patients with painful osteoarthritis (OA) of the knee. Population: 60 patients, aged 50 and above, with painful OA of the knee. Interventional measures: Pulsed or heated RF treatment of the genicular nerves of the involved knee. Outcome measures: primary - fraction of patients experiencing improvement of 50% or higher in their average pain rating during stair climbing. secondary - improved quality of life - improved functional capacity - comparison of side effects and adverse events - change in the consumption of analgesic medications","other_id":"0087-19-RMB CTIL","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Radiologically proven OA of knee with a 2. Kellgren-Lawrence scale (K-L score) of 3 to\r\n             4.\r\n\r\n          -  Clinically proven OA of knee with an Oxford knee score of 0 to 30 (representing\r\n             moderate to severe OA).\r\n\r\n          -  Chronic knee pain due to the OA of knee (>3 months) of at least moderate severity by a\r\n             Visual Analogue Scale (VAS) 4 and above.\r\n\r\n          -  Signed informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Acute knee pain\r\n\r\n          -  Disease that preclude per clinician decision interventional treatment.\r\n\r\n          -  Allergic reaction to the injected substances (triamcinolone, lidocaine)\r\n\r\n          -  Injections to the knee during the 3 months preceding recruitment\r\n\r\n          -  Distorted knee intervention due to any cause, which interferes with the radiological\r\n             identification of targeted RF sites.\r\n\r\n          -  Anticoagulation treatment that cannot be stopped.\r\n      ","sponsor":"Rambam Health Care Campus","sponsor_type":"Other","conditions":"Osteoarthritis, Knee","interventions":[{"intervention_type":"Device","name":"Device: Radiofrequency ablation","description":"Pulsed or heated RF ablation of the genicular nerves will be done as an Acceptable treatment for OA of the knee"}],"outcomes":[{"outcome_type":"primary","measure":"Knee pain reduction","time_frame":"3 months","description":"Reduction in knee pain during stairs climbing by at least 50% in a 1-10 Numerical Rating Scale (NRS) pain severity score and a comparison between the 2 techniques outcomes."},{"outcome_type":"secondary","measure":"quality of life measurements improvement","time_frame":"3 months","description":"Improvement in quality of life measures using The Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionaires"},{"outcome_type":"secondary","measure":"Adverse events","time_frame":"3 months","description":"Comparison of the two groups"}]}
{"nct_id":"NCT04418271","start_date":"2020-06-30","phase":"N/A","enrollment":1400,"brief_title":"Prehabilitation of Elderly Patients With Frailty Syndrome Before Elective Surgery (PRAEP-GO)","official_title":"Prehabilitation of Elderly Frail or Pre-frail Patients Prior to Elective Surgery - a Randomized Controlled Multicenter Study (PRAEP-Go)","primary_completion_date":"2022-11-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-11-30","last_update":"2021-06-21","description":"The aim of the study is to evaluate the effect of a shared decision-making conference and three-week prehabilitation program on the outcome \"care dependency\" one year after surgery. The cost-effectiveness of the intervention will also be evaluated in this N = 1400 patient, national multicenter, assessor-blinded, randomized, pragmatic, controlled, parallel-group, clinical trial. The objective of PRP-GO is to establish and employ a suitable preoperative case-care management system to improve the short and long-term outcome of elderly surgical patients with signs of a frailty syndrome, improving postoperative quality of life and reducing care dependency by a three-week individualized prehabilitation program.","other_id":"PRAEP-GO","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","intervention_model_description":"Patients with frailty syndrome (1 of the standardized parameters (Pre-Frail = 1-2; Frail3) according to Fried et al.(2001) are offered randomised participation in the new form of care.","sampling_method":"","gender":"All","minimum_age":70,"population":"","criteria":"\n        Study patients:\r\n\r\n        Inclusion Criteria:\r\n\r\n          -  Age  70 years\r\n\r\n          -  Consent by Patient or Legal Representative\r\n\r\n          -  Elective surgery planned\r\n\r\n          -  Expected anesthesia duration 60 min\r\n\r\n          -  Statutory health insurance\r\n\r\n          -  Frailty syndrome (1 positive out of 5 standardized parameters according to the\r\n             Physical Frailty Phenotype according to Fried et. al.)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Severe cardiac or pulmonary disease (NYHA IV, Gold IV)\r\n\r\n          -  Intracranial interventions\r\n\r\n          -  Moribund patients (palliative situation)\r\n\r\n          -  Not enough language skills\r\n\r\n          -  Participation in another interventional rehabilitation study or other interventional\r\n             clinical trial that has not been approved by the study management committee\r\n             (Exception: Participation in adjuvant intervention study)\r\n      ","sponsor":"Charite University, Berlin, Germany","sponsor_type":"Other","conditions":"Frailty|Frail Elderly","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Prehabilitation- new form of care","description":"The participants in the intervention group take part in a shared decision-making (SDM) conference to plan the intervention. The therapeutic content of the prehabilitation is defined individually for each patient in the SDM conference. Prehabilitation will be a structured and individually tailored 3-week program."}],"outcomes":[{"outcome_type":"secondary","measure":"Survival","time_frame":"Up to one year","description":"Data from patient records and residents' registration"},{"outcome_type":"secondary","measure":"Social situation measurement 2","time_frame":"Up to one year","description":"The social situation 2 of the patient is measured by BSSS, 8-items"},{"outcome_type":"secondary","measure":"Fear of Falling","time_frame":"Up to one year","description":"Activities-Specific Balance Confidence (ABC)-6-Scale. The scale consists of 6 questions who are rated on a 0-100 NRS-scale. The total result of the ABC-6-scale comprises of the average of all 6 items."},{"outcome_type":"secondary","measure":"Loneliness","time_frame":"Up to one year","description":"Frequency of sensations of loneliness; 3-item UCLA Loneliness Scale"},{"outcome_type":"primary","measure":"Degree of care dependency","time_frame":"Up to one year","description":"Assessment results in a degree of care dependency from personal help according to the German dependency assessment (= \"Neues Begutachtungs-Assessment\" (NBA)) (Wingenfeld et al., 2008). The results of the assessments ranges between 0 and 100 points, which are transformed into a 0-5 ordinal scale. Higher points in the assessments indicate higher demand of care dependency. Accordingly, higher numbers on the ordinal scale indicate a higher level of care dependency as defined in the German statutory care insurance program."},{"outcome_type":"secondary","measure":"Neurocognitive Disorder (NCD)","time_frame":"Up to one year","description":"New diagnosis of mild/major Neurocognitive Disorder at 3 and 12 months. The diagnosis is made based on DSM-V criteria including a multi-component cognitive test battery comparing with baseline testing and comparison to a non-surgical observational control group."},{"outcome_type":"secondary","measure":"Suspected Neurocognitive disorder by MiniCog","time_frame":"Up to one year","description":"Dementia is suspected by limited MiniCog-test result. The MiniCog consists of two items, the word recall test and the clock-drawing test. Performance in these test is rated on a scale ranging from 0 - 5, with <3 points indicating a suspicion of dementia."},{"outcome_type":"secondary","measure":"Suspected Dementia by MOCA","time_frame":"Up to one year","description":"Dementia is suspected by a Montreal Cognitive Assessment (MOCA) according to normative age-adjusted values. The MOCA consists of 13 items which are rated on a scale between 0 and 30 points."},{"outcome_type":"secondary","measure":"Suspected postoperative neurocognitive disorder (POCD)","time_frame":"Up to one year","description":"The non-computerized neuropsychological Trail Making Test are used as indicator screening test for relevant cognitive change after surgery. An increase of >55 seconds in TMT-B test performance at three and/or 12 months after surgery compared to baseline is set as cut off."},{"outcome_type":"secondary","measure":"Frailty","time_frame":"Up to one year","description":"Frailty is operationalized using modified Fried frailty criteria. Frailty scores from 0 to 5 (i.e., 1 point for each component; 0 = best to 5 = worst) represent robust (0), pre-frail (1-2), and frail (3-5) health status."},{"outcome_type":"secondary","measure":"Polypharmacy","time_frame":"Up to one year","description":"Measured by number of drug agents"},{"outcome_type":"secondary","measure":"Alcohol Use","time_frame":"Up to one year","description":"Measured by number of drug agents"},{"outcome_type":"secondary","measure":"Tobacco Use","time_frame":"Up to one year","description":"Measured by Fagerstrom (Fagerstrom & Schneider, 1989)"},{"outcome_type":"secondary","measure":"Intraoperative Neuromonitoring","time_frame":"During surgery","description":"Monitoring of electroencephalography during surgery"},{"outcome_type":"secondary","measure":"Result of surgery","time_frame":"Up to one year","description":"Incidence of complications (intra- and post-operative)"},{"outcome_type":"secondary","measure":"Autonomy Preference","time_frame":"At the beginning of the observation","description":"Extent of patients' autonomy preference concerning medical decisions; Autonomy-Preference-Index, modified German version (API-Dm). The scale consists of a 11-item questionnaire with 4 questions on preferred autonomy in health-related decisions and 7 items on information preference. The total results of the API and both subscales are transformed into a 0 - 100 scale with higher values indicating higher levels on autonomy and information preference, respectively."},{"outcome_type":"secondary","measure":"Extent of involvement in shared decision-making process","time_frame":"At the beginning of the observation","description":"Extent of patients, relatives and health professionals' involvement in shared decision-making process; 9-Item Shared Decision Making Questionnaire (SDM-Q-9/SDM-Q-Doc)"},{"outcome_type":"secondary","measure":"Arm circumference","time_frame":"Up to one year","description":"Arm circumference is measured in a standardized position and documented in centimeter."},{"outcome_type":"secondary","measure":"Calf circumference","time_frame":"Up to one year","description":"Calf circumference is measured in a standardized position and documented in centimeter."},{"outcome_type":"secondary","measure":"Mini Nutritional Assessment-Short","time_frame":"Up to one year","description":"Nutritional Status is measured using Mini Nutritional Assessment-Short-form (MNA-SF)."},{"outcome_type":"secondary","measure":"Sarcopenia","time_frame":"Up to one year","description":"Sarcopenia is evaluated as a composite measure by three criteria that are assessed: 1) low muscle strength (hand grip strength), 2) low muscle quantity (calf circumference) and 3) low physical performance (gait speed)."},{"outcome_type":"secondary","measure":"Independence of Functional Status","time_frame":"Up to one year","description":"Assessment of the patient's independence in mobilization, i.e. mobilization in daily living without personnel or device support."},{"outcome_type":"secondary","measure":"Functional endurance","time_frame":"Up to one year","description":"Functional endurance is measured using the 2-Minute-Step-Test (2-MST). The patient steps in place, raising each leg to a marker. The markers height is derived from biometrical measures of the patient. The assessor counts each step of the right leg in which the knee of the patient passes the marker. Higher counts of steps indicates better functional endurance."},{"outcome_type":"secondary","measure":"Function of the respiratory system","time_frame":"Up to one year","description":"The function of the respiratory system is assessed by expiratory peak flow measurement as surrogate parameter."},{"outcome_type":"secondary","measure":"Depression","time_frame":"Up to one year","description":"Depression is measured by frequency of depressive symptoms; Patient Health Questionnaire-8 (PHQ-8)]"},{"outcome_type":"secondary","measure":"Anxiety","time_frame":"Up to one year","description":"Anxiety is measured frequency of anxiety symptoms; Generalized Anxiety Disorder Scale-7 (GAD-7)"},{"outcome_type":"secondary","measure":"Frequency of depressive and anxiety symptoms","time_frame":"Up to one year","description":"Frequency of depressive and anxiety symptoms; Patient Health Questionnaire-4 (PHQ-4)]"},{"outcome_type":"secondary","measure":"Health related quality of life","time_frame":"Up to one year","description":"Health related quality of life is measured with EQ-5D-5L questionnaire."},{"outcome_type":"secondary","measure":"Patient-reported Functioning and Disability (WHO Disability Assessment) Schedule)","time_frame":"Up to one year","description":"Patient-reported functioning and disability is measured by patient self report of functioning and disability due to health conditions; WHO Disability Assessment Schedule (WHODAS 2.0, 12-item version)"},{"outcome_type":"secondary","measure":"Proxy-reported Functioning and Disability (WHO Disability Assessment) Schedule)","time_frame":"Up to one year","description":"Proxy-reported Functioning and Disability is measured by Proxy-rated functioning and disability due to health conditions; WHO Disability Assessment Schedule (WHODAS 2.0, 12-item Version)"},{"outcome_type":"secondary","measure":"Falls","time_frame":"Up to one year","description":"Incidence of falls"},{"outcome_type":"secondary","measure":"Social situation measurement 1","time_frame":"Up to one year","description":"The social situation 1 of the patient is measured by a Questionnaire for Social Situation (SOS, Subscales 1 and 2)."},{"outcome_type":"secondary","measure":"Pain: Numeric rating scale","time_frame":"Up to one year","description":"Pain is measured with a pain score Numeric rating scale (0-10), a higher score indicates more pain."},{"outcome_type":"secondary","measure":"Satisfaction with the prehabilitation and overall process: ZUF-8","time_frame":"Up to one year","description":"The satisfaction of the patient is measured with the questionnaire on patient satisfaction (ZUF-8). The ZUF-8 is a questionnaire on patient satisfaction after treatment. It consists of 8 questions which results in a score between 0 and 24 points, with higher values.indicating higher levels of satisfaction."},{"outcome_type":"other","measure":"Length of stay Intensive Care Unit","time_frame":"Participants are followed up for the duration of rehabilitation, an expected average of 1 day]","description":"Intensive care unit length of stay describes every day spent in an ICU bed."},{"outcome_type":"other","measure":"Admission Intensive Care Unit (ICU) Admission rate on Intensive Care Unit (ICU)","time_frame":"Participants are followed up for the duration of rehabilitation, an expected average of 1 day]","description":"Admission rate (planned / unplanned) on ICU"},{"outcome_type":"other","measure":"Duration of hospital stay","time_frame":"Participants are followed up for the duration of rehabilitation, an expected average of 7 days]","description":"Time in hospital"},{"outcome_type":"other","measure":"Adverse Discharge Disposition","time_frame":"Participants are followed up after hospital discharge for 1 day","description":"Adverse discharge disposition other than to home and planned rehabilitation facility."},{"outcome_type":"other","measure":"Necessity for follow-up treatment and rehabilitation","time_frame":"Up to one year","description":"Assessment if a follow-up treatment or rehabilitation is necessary after the hospital stay."},{"outcome_type":"other","measure":"Count of new discharge diagnoses","time_frame":"Participants are followed up for the duration of rehabilitation, an expected average of 7 days]","description":"New medical diagnoses at hospital discharge compared to baseline are assessed."},{"outcome_type":"other","measure":"Count of new discharge medication","time_frame":"Participants are followed up for the duration of rehabilitation, an expected average of 7 days]","description":"New medication at hospital discharge compared to baseline is assessed."},{"outcome_type":"other","measure":"Duration of rehabilitation","time_frame":"Participants are followed up for the duration of rehabilitation, an expected average of 25 days]","description":"Patient record data, discharge letter"},{"outcome_type":"other","measure":"Health economic benefit","time_frame":"Up to one year","description":"ScreeningThe health economic benefit of the intervention (prehabilitation) will be compared to standard of care in the German health care system using a health cost analysis framework."},{"outcome_type":"other","measure":"Adequacy of exercise interventions","time_frame":"Up to one year","description":"Assessment of the appropriateness of the quantity and quality of the exercise interventions compared to exercise prescription guidelines."},{"outcome_type":"other","measure":"Evaluation of the nutritional intervention","time_frame":"Up to three weeks","description":"Questionnaire on operability of the nutritional intervention and dietary records"},{"outcome_type":"other","measure":"Anesthesia duration","time_frame":"During surgery","description":"Measured form anesthesia induction until stop of anesthesia (Patient records)"},{"outcome_type":"other","measure":"Preoperative Cognitive Impairment","time_frame":"At baseline","description":"For NCD diagnosis at baseline (Preoperative Cognitive Impairment) the same distinction criteria for mild and major NCD were applied, although here formal neurocognitive test performance at baseline was compared to the corresponding mean baseline value in the non-surgical control group."},{"outcome_type":"other","measure":"Assistive Devices (Hilfsmittel)","time_frame":"Up to one year","description":"The need of any aid and device that is designed, made, or adapted to assist a patient perform a particular task."},{"outcome_type":"other","measure":"Treatment (Heilmittel)","time_frame":"Up to one year","description":"The need of a substance or method for curing an illness."}]}
{"nct_id":"NCT04450290","start_date":"2020-06-30","phase":"N/A","enrollment":10,"brief_title":"Dexamethasone-Eluting Cochlear Implant Electrode","official_title":"Dexamethasone-Eluting Cochlear Implant Electrode (CIDEXEL): A First in Human Study","primary_completion_date":"2022-04-01","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2022-04-01","last_update":"2021-07-27","description":"A newly developed MED-EL Cochlear Implant incorporates the anti-inflammatory agent dexamethasone (DEX) into the electrode array. The passive elution of DEX during the post-implantation period has the purpose of counteracting the increase of the post-operative impedance induced by the insertion trauma. The aim of this clinical investigation is to obtain a first experience in use of the investigational device in the adult clinical population, and to initially assess tools, techniques and performance outcome measures that may be considered in future clinical studies of similar devices.","other_id":"MED-EL_CRD_2014_02","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Device Feasibility","masking_description":"None (Open Label)","intervention_model_description":"First-in-human, single-arm, exploratory, open-label, prospective, longitudinal, monocentric study","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Minimum age of eighteen (18) years at time of enrolment.\r\n\r\n          -  Severe to profound sensorineural hearing loss on the ipsilateral ear.\r\n\r\n          -  A functional auditory nerve in the ear to be implanted.\r\n\r\n          -  Subjects reporting to having used an optimally fit hearing aids for a minimum of three\r\n             months before the decision that a cochlear implant (CI) is the preferential option.\r\n\r\n          -  Cochlea anatomy compatible with the insertion of a +FLEX28 electrode array.\r\n\r\n          -  Compatibility with a soft surgery approach as per clinical practice at the site.\r\n\r\n          -  Post-lingual hearing impairment.\r\n\r\n          -  Subject fulfilling indication criteria for a CI according to the local professional\r\n             standards, as reported by the implanting surgeon.\r\n\r\n          -  General health condition, psychological and emotional condition deemed compatible with\r\n             the treatment and tests performed in this study and realistic expectations, as deemed\r\n             appropriate by the implanting surgeon.\r\n\r\n          -  Signed and dated informed consent before the start of any study-specific procedure.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Lack of compliance with any inclusion criterion.\r\n\r\n          -  Previously having received a cochlear implant on the ear chosen for placing the IMD\r\n             (Investigational Medical Device).\r\n\r\n          -  Evidence of ossification or any other cochlear anomaly that might prevent complete\r\n             insertion of the electrode array or might cause increased risk of infection (e.g.\r\n             dysplastic cochlea), as confirmed by medical examination and/or as per CT/MRT\r\n             (Computed Tomography/Magnetic Resonance Tomography).\r\n\r\n          -  Evidence of anatomic abnormalities that would prevent appropriate placement of the\r\n             stimulator housing in the bone of the skull.\r\n\r\n          -  Evidence of otosclerosis.\r\n\r\n          -  Known allergic reaction or intolerance to the materials used in the implant (including\r\n             medical grade silicone, platinum, iridium, parylene c, dexamethasone).\r\n\r\n          -  Known absence of cochlear development or if the cause of deafness is non-functionality\r\n             of the auditory nerve and/or the upper auditory pathway.\r\n\r\n          -  Evidence of active external or middle ear infection or history of recurrent middle ear\r\n             infection in the ear to be implanted.\r\n\r\n          -  Evidence of perforated tympanic membrane in the ear to be implanted.\r\n\r\n          -  Patient reporting immunosuppressive therapy or corticosteroids therapy in the 4 weeks\r\n             before enrolment.\r\n\r\n          -  Evidence of concomitant use of medicinal substances that, in the opinion of the\r\n             investigator, could alter the therapeutic efficacy of dexamethasone.\r\n\r\n          -  Unwillingness or inability of the candidate to comply with all investigational\r\n             requirements.\r\n\r\n          -  Evidence of medical contraindications to surgery of the middle and inner ear and\r\n             anaesthesia.\r\n\r\n          -  Additional disabilities that would prevent or restrict participation in the\r\n             audiological and medical evaluations required of the clinical investigation.\r\n      ","sponsor":"MED-EL Elektromedizinische Gerte GesmbH","sponsor_type":"Industry","conditions":"Hearing Loss, Sensorineural|Sensorineural Hearing Loss","interventions":[{"intervention_type":"Device","name":"Device: CIDEXEL implant","description":"The newly developed MED-EL Cochlear Implant incorporates the anti-inflammatory agent dexamethasone (DEX) into the electrode array. The passive elution of DEX during the post-implantation period has the purpose of counteracting the increase of the post-operative impedance induced by the insertion trauma."}],"outcomes":[{"outcome_type":"primary","measure":"Adverse Events","time_frame":"10 months","description":"Safety profile of the device which will be evaluated through the analysis of adverse events"},{"outcome_type":"secondary","measure":"IFT (Impedance Field Telemetry) - impedance","time_frame":"10 months","description":"Impedance Field Telemetry and derived values"},{"outcome_type":"secondary","measure":"Electrically Evoked Compound Action Potential","time_frame":"10 months","description":"Electrically Evoked Compound Action Potential and derived values"},{"outcome_type":"secondary","measure":"MCL (Maximum Comfortable Loudness)","time_frame":"10 months","description":"Maximum Comfortable Loudness Levels and Thresholds"},{"outcome_type":"secondary","measure":"THR (Threshold)","time_frame":"10 months","description":"Thresholds"},{"outcome_type":"secondary","measure":"PTA (Pure Tone Audiometry) Audiometrical values","time_frame":"10 months","description":"Results from PTA assessment"},{"outcome_type":"secondary","measure":"Hearing Preservation rate","time_frame":"10 months","description":"Rate of Hearing Preservation according to Skarżyński et al."},{"outcome_type":"secondary","measure":"HSM (Hochmair-Schulz-Moser Sentence) Test","time_frame":"10 months","description":"Speech test in noise"},{"outcome_type":"secondary","measure":"Questionnaire","time_frame":"10 months","description":"Surgical feedback questionnaire"}]}
{"nct_id":"NCT04446585","start_date":"2020-06-29","phase":"N/A","enrollment":260,"brief_title":"Cardiac Arrest in Residential Areas With Mobile First-responder Activation","official_title":"A Cluster Randomized Clinical Trial of Strategic AED Deployment in High-risk Residential Areas Combined With Activation of Local Residents","primary_completion_date":"2025-09-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2025-09-30","last_update":"2020-08-13","description":"The study aims to increase proportions of bystander defibrillation during out-of-hospital cardiac arrest (hereof referred to as cardiac arrest) in residential areas with a high density of cardiac arrests. The intervention consists of Automated External Defibrillators (AEDs) and residents' involvement in resuscitation through training and enrollment as citizen responders.","other_id":"111","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":8,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  All witnessed cardiac arrests recognized registered in the Danish Cardiac Arrest\r\n             Registry occurring within the study sites. This excludes non witnessed cardiac\r\n             arrests.\r\n\r\n          -  Witnessed cardiac arrest\r\n\r\n          -  Non-traumatic etiology, this excludes intoxication, drowning or suicide.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Cardiac arrest occurring in a nursing home\r\n\r\n          -  Cardiac arrest not treated by the EMS due to ethical reasons or obvious signs of death\r\n\r\n          -  Not true cardiac arrest (suspected, but not verified)\r\n\r\n          -  Cardiac arrests witnessed by the emergency medical personnel\r\n      ","sponsor":"Emergency Medical Services, Capital Region, Denmark","sponsor_type":"Other","conditions":"Out-Of-Hospital Cardiac Arrest","interventions":[{"intervention_type":"Device","name":"Device: Automated External Defibrillator (AED)","description":"Deployment of AEDs"},{"intervention_type":"Other","name":"Other: Training in cardiopulmonary resuscitation and AED use","description":"Residents will undergo 30-minute courses at study start and if needed during the trial period. During the course they will also be recruited as citizen responders"},{"intervention_type":"Other","name":"Other: Activation of citizen responders","description":"Citizen responders will be activated in case of suspected cardiac arrest through the heart runner app."}],"outcomes":[{"outcome_type":"primary","measure":"Bystander defibrillation","time_frame":"Up to five years after implementation of the intervention","description":"Proportion of bystander defibrillation of witnessed cardiac arrests"},{"outcome_type":"secondary","measure":"30-day survival","time_frame":"30 days after date of cardiac arrest","description":"Proportion of patients alive 30 days after date of cardiac arrest"}]}
{"nct_id":"NCT04368676","start_date":"2020-06-25","phase":"Early Phase 1","enrollment":60,"brief_title":"Breath Regulation and Yogic Exercise An Online Therapy for Calm and Happiness During the COVID-19 Pandemic","official_title":"Breath Regulation and Yogic Exercise An Online Therapy for Calm and Happiness (BREATH): an RCT for Frontline Hospital and Long-term Care Home Staff Managing the COVID-19 Pandemic","primary_completion_date":"2022-06-30","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2022-06-30","last_update":"2021-04-01","description":"This study will examine the feasibility of conducting an online Randomized Controlled Trial (RCT) in frontline hospital and long term care healthcare staff in managing COVID-19 patients in London, ON. The study will randomize participants to Sudarshan Kriya Yoga (SKY) or a Health Enhancement Program (HEP).","other_id":"115855","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Participants will be frontline hospital or long-term care home staff involved in the\r\n             management of COVID-19 patients in Canada or The United States of America.\r\n\r\n          2. Participants will be aged 18 to 70.\r\n\r\n          3. Participants will be willing and able to attend, via WebEx software, the introductory\r\n             phase of SKY or HEP, as well as at least two of the four weekly follow-up sessions\r\n\r\n          4. Have sufficient hearing to follow verbal instructions.\r\n\r\n          5. Have an adequate understanding of English.\r\n\r\n          6. Able to sit without physical discomfort for 60 minutes.\r\n\r\n          7. Not pregnant and willing to remain not pregnant for the duration of the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Inability to independently provide informed consent.\r\n\r\n          2. Current suicidality as assessed by the suicide item of the Patient Health\r\n             Questionnaire-9 scale.\r\n\r\n          3. History of bipolar disorder.\r\n\r\n          4. History of chronic PTSD.\r\n\r\n          5. History of schizophrenia or schizoaffective disorder.\r\n\r\n          6. Currently practice any type of formal meditation, mindfulness, or breathing techniques\r\n             regularly (greater than 3 times per week).\r\n\r\n          7. History of complex PTSD.\r\n      ","sponsor":"Lawson Health Research Institute","sponsor_type":"Other","conditions":"Job Stress|Workplace Stress|Compassion Fatigue|Psychological Trauma|Healthcare Workers|Healthcare Providers","interventions":[{"intervention_type":"Other","name":"Other: Sudarshan Kriya Yoga (SKY)","description":"The SKY program is a standardized, easy to learn sequential breathing yoga consisting of regulated breathing techniques followed by a timed rhythmic breathing practice. Participants will learn various exercises including rhythmic breathing, gentle yoga, and guided meditation."},{"intervention_type":"Other","name":"Other: Health Enhancement Program","description":"HEP is a structured group program designed to help participants with information and instruction how to lead a healthier life. Participants will be provided psychoeducation and support regarding healthy active living using techniques like music therapy, diet control, exercise, and monitoring these via journaling."}],"outcomes":[{"outcome_type":"primary","measure":"Rate of participant recruitment","time_frame":"1 year","description":"The number of participants recruited per month will be calculated as a feasibility measure."},{"outcome_type":"primary","measure":"Rate of retention","time_frame":"1 year","description":"The retention rate of participants will be calculated as a feasibility measure."},{"outcome_type":"primary","measure":"Completeness of data entry","time_frame":"1 year","description":"The completeness of study assessments will be assessed as a feasibility measure by calculating the missing percentage of data in case report forms."},{"outcome_type":"primary","measure":"Cost of interventions","time_frame":"1 year","description":"The cost of both study interventions will be calculated to assess the total study cost for interventions and the cost per participant. This information will be used as a feasibility measure."},{"outcome_type":"primary","measure":"Unexpected costs","time_frame":"1 year","description":"The total of unexpected costs will be calculated as a feasibility measure."},{"outcome_type":"secondary","measure":"Change in Athens Insomnia Scale","time_frame":"Change from Week 0 to week 3 and to week 5","description":"The Athens Insomnia Scale will be used to assess insomnia. This scale is an 8-item, self-rated measure of the extent of sleep difficulties over the last 30 days with each item representing a different aspect of sleep (e.g. \"Overall Quality of Sleep\"). Ratings are from 0 to 4, with 0 being no difficulty with the item and 4 being the most difficulty with the item. Higher overall scores on this scale indicate higher difficulties with sleep."},{"outcome_type":"secondary","measure":"Change in Generalized Anxiety Disorder 7-item scale","time_frame":"Change from Week 0 to week 3 and to week 5","description":"The Generalized Anxiety Disorder 7-item scale (each scored 0-3) is a self-rated measure of anxiety and has been validated for the diagnosis of Generalized Anxiety Disorder in the adult population. Scores range from 0 to 21. Higher scores indicate greater anxiety symptoms (5-9, mild anxiety; 10-14, moderate anxiety; 15-21 severe anxiety)."},{"outcome_type":"secondary","measure":"Change in Patient Health Questionnaire 9","time_frame":"Change from Week 0 to week 3 and to week 5","description":"The Patient Health Questionnaire (PHQ-9) is a 9-item, self-rated measure of depression which has been validated for screening a major depressive episode in adults. Total scores indicate various levels of depression: 0-4, no depression; 5-9, mild depression; 10-14, moderate depression; 15-19, moderately severe depression; 20-27, severe depression."},{"outcome_type":"secondary","measure":"Change in Connor-Davidson Resilience Scale","time_frame":"Change from Week 0 to week 3 and to week 5","description":"The Connor-Davidson Resilience Scale (CD-RISC) is a brief self-rated assessment tool that comprises of 10 items, each rated on a 5-point Likert scale (0 = not true at all to 4 = true nearly all the time). Higher scores reflect greater resilience, which is a measure of one's ability to cope with stress. The scale demonstrated strong reliability and validity and has been studied in a variety of populations including medical personnel, nurses, social workers and physicians)."}]}
{"nct_id":"NCT04483284","start_date":"2020-06-24","phase":"Phase 2","enrollment":60,"brief_title":"Study of TACE Combined With Camrelizumab in the Treatment of HCC Patients","official_title":"Exploratory Clinical Study of TACE Combined With Camrelizumab in the Treatment of BCLC Stage B and Stage C Hepatocellular Carcinoma","primary_completion_date":"2020-12-31","study_type":"Interventional","rec_status":"Enrolling by invitation","completion_date":"2021-12-31","last_update":"2020-07-23","description":"It is an exploratory clinical study aimed to evaluate the efficacy and safety of TACE combined with Camrelizumab in the treatment of patients with BCLC stage B and C HCC.Treatment will continue until disease progression or intolerable toxicity or patients withdrawal of consent,and the target sample size is 60 individuals.","other_id":"MA-HCC--003","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  1.Patients voluntarily entered the study and signed informed consent form (ICF) 2.\r\n             Age: 18 - 80 years old and life expectancy of at least 12 weeks.; 3. Clinically or\r\n             histologically diagnosed as HCC; 4. There are measurable lesions that meet the\r\n             RECIST1.1 standard on the baseline imaging examination; 5. Child-pugh classification A\r\n             or B (score < 7); 6. The BCLC stage is stage B or C, and it is unable or unwilling to\r\n             undergo surgical treatment; 7. ECOG : 0 ~ 1 ; 8. No previous immune checkpoint\r\n             inhibitor treatment (including PD-1 / PD-L1 antibody and CTLA-4 inhibitor); 9.\r\n             HBV-deoxyribonucleic acid (DNA) must be <500IU / mL, and receive at least 14 days of\r\n             anti-HBV treatment before the start of study treatment Treatment;\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  1. History of treatment with any local treatment (exception of liver transplantation),\r\n             systemic .anti-cancer therapy, or immunotherapy; 2. Those whose tumor thrombus reaches\r\n             or exceeds the main portal vein; 3. Existing or concurrently suffering from other\r\n             malignant tumors, except for fully treated non-melanoma skin cancer, cervical\r\n             carcinoma in situ, and papillary thyroid carcinoma; 4. There is any active autoimmune\r\n             disease or has a history of autoimmune disease and may relapse; 5. Use strong CYP3A4 /\r\n             CYP2C19 inducers including rifampicin and Hypericum perforatum or strong CYP3A4 /\r\n             CYP2C19 inhibitors within 14 days before starting the study treatment; 6. Known\r\n             history of severe allergy to any monoclonal antibody; 7. Patients who are going to\r\n             undergo or have undergone organ or allogeneic bone marrow transplantation; 8.\r\n             Non-compliance with TACE or Camrelizumab; 9. Moderate and severe ascites with clinical\r\n             symptoms require therapeutic puncture, drainage, or Childa-Pugh score> 2 (except\r\n             imaging only shows a small amount of ascites but not accompanied by clinical\r\n             symptoms); uncontrolled or moderate and Above pleural effusion and pericardial\r\n             effusion; 10. Abdominal fistula, gastrointestinal perforation or abdominal abscess\r\n             occurred within 6 months before the start of the study treatment; 11. Thrombosis or\r\n             embolism occurred within 6 months before the start of study treatment, such as\r\n             cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage,\r\n             cerebral infarction, pulmonary embolism, etc.) 12. Known inherited or acquired\r\n             bleeding or thrombophilia ; currently or recently (10 days prior to the start of study\r\n             treatment) have used full dose oral or Injection of anticoagulant drugs or\r\n             thrombolytic drugs (prophylactic use of low-dose aspirin and low molecular weight\r\n             heparin); 13. Major vascular disease within 6 months before the study treatment; 22.\r\n             Past or present central nervous system metastasis; 14. Metastatic diseases involving\r\n             major airways or blood vessels or a large mediastinal tumor mass in the center (<30 mm\r\n             from the crest) 15. Those with a history of hepatic encephalopathy; 16. Palliative\r\n             radiotherapy for non-target lesions allowed for symptom control must be completed at\r\n             least 2 weeks before the start of study treatment. Adverse events caused by\r\n             radiotherapy have not recovered to CTCAE level 1; 17. There were severe infections\r\n             within 4 weeks before starting the study treatment; 18. Patients with congenital or\r\n             acquired immune deficiency (such as those infected with HIV); 19. Co-infection with\r\n             hepatitis B and C; 20. For patients with bone metastases, the palliative radiotherapy\r\n             area> 5% bone marrow area received within 4 weeks before participating in the study;\r\n      ","sponsor":"Shanghai Zhongshan Hospital","sponsor_type":"Other","conditions":"Hepatocellular Carcinoma","interventions":[{"intervention_type":"Drug","name":"Drug: TACE combined with Camrelizumab","description":"Camrelizumab(200mg q3w ivgtt) combined with TACE"},{"intervention_type":"Procedure","name":"Procedure: TACE plus Camrelizumab","description":"Camrelizumab(200mg q3w ivgtt) combined with TACE"}],"outcomes":[{"outcome_type":"primary","measure":"Progression Free Survival","time_frame":"an expected average of 8 months","description":"the time from enrollment to the first disease progression or death from any cause"},{"outcome_type":"secondary","measure":"Time to progression","time_frame":"An expected average of 8 months","description":"the time from enrollment to the first disease progression"},{"outcome_type":"secondary","measure":"Overall survival","time_frame":"An expected average of 24 months","description":"the time from enrollment to the death from any cause"},{"outcome_type":"secondary","measure":"Objective response rate","time_frame":"An expected average of 8 months","description":"evaluated by investigators with mRECIST"},{"outcome_type":"secondary","measure":"Disease control rate","time_frame":"An expected average of 8 months","description":"evaluated by investigators with mRECIST"},{"outcome_type":"secondary","measure":"Duration of response","time_frame":"An expected average of 8 months","description":"evaluated by investigators with mRECIST"},{"outcome_type":"secondary","measure":"The incidence of AEs and SAEs by NCI-CTCAE v5.0","time_frame":"An expected average of 8 months","description":"Safety index"}]}
{"nct_id":"NCT04429919","start_date":"2020-06-22","phase":"Phase 2","enrollment":94,"brief_title":"AP-325 in Subjects With Peripheral Post-surgical Neuropathic Pain","official_title":"A Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of AP-325 in Subjects With Peripheral Post-surgical Neuropathic Pain","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-02-28","last_update":"2021-09-08","description":"This is a Phase IIa randomized, double-blind, placebo-controlled study. The study objective is to investigate the efficacy and safety of repeat oral dosing of the investigational medicinal product (IMP) AP-325 for the treatment of peripheral post-surgical neuropathic pain (PPNP) after breast surgery (breast cancer interventions), chest surgery (i.e. thoracotomy, video assisted thoracoscopy and sternotomy) or groin hernia repair (i.e. femoral hernia repairs and inguinal hernia repairs).","other_id":"AP-325.04","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","intervention_model_description":"placebo controlled, Phase IIa clinical trial","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Subjects must be at least 18 years and not older than 80 years\r\n\r\n          2. Subjects with a diagnosis of chronic post-surgical neuropathic pain after breast\r\n             surgery (breast cancer interventions), chest surgery (i.e. thoracotomy, video assisted\r\n             thoracoscopy and sternotomy) or groin hernia repair (i.e. femoral hernia repairs and\r\n             inguinal hernia repairs)\r\n\r\n          3. The chronic post-surgical pain developed or increased in intensity after the surgical\r\n             procedure and persisted beyond the healing process, i.e. at least 3 months after the\r\n             initiating event, as defined according to the international association for the study\r\n             of pain (IASP) classification of chronic pain for ICD-11 (Schug et al., 2019)\r\n\r\n          4. Subjects must have 'probable' or 'definite' neuropathic pain as assessed by the\r\n             revised IASP special interest group on neuropathic pain (NeuPSIG) grading system\r\n             (Finnerup et al., 2016)\r\n\r\n          5. Subjects must be willing and able to discontinue and washout prohibited substances\r\n             including\r\n\r\n               -  pain medications (e.g. antidepressants, anticonvulsants/antiepileptics, selective\r\n                  serotonin and dual reuptake inhibitors, opioids, long-acting benzodiazepines,\r\n                  muscle relaxants, and topical analgesics), except the rescue medication, and\r\n\r\n               -  substances known to be inhibitors or inducers of CYP2C9 and inhibitors of CYP3A4\r\n                  for specific washout periods of at least 5 times the drug half-life Note:\r\n                  Subjects using prohibited substances for other indications than neuropathic pain,\r\n                  e.g. antiepileptics for the treatment of epilepsy, may not be included in the\r\n                  study, because a discontinuation of such medication is not medically justifiable.\r\n\r\n          6. Permitted concomitant medications must have been stable for at least 4 weeks prior to\r\n             Day -14 and any non-pharmacological therapies (e.g. physiotherapy, acupuncture and\r\n             transcutaneous electrical neural stimulation) must have been initiated at least 3\r\n             weeks prior to Screening\r\n\r\n          7. Female subjects must not be pregnant or breastfeeding and be\r\n\r\n               -  of non-childbearing potential or\r\n\r\n               -  if of childbearing potential, use a highly effective contraceptive method from\r\n                  start of the IMP intake until 30 days after the last IMP intake and have a\r\n                  negative pregnancy test at Screening (blood test)\r\n\r\n          8. Male subjects must agree, from start of the IMP intake until 3 months after the last\r\n             IMP intake, to refrain from donating sperm and use a male condom when having sexual\r\n             intercourse with a woman of childbearing potential at any time and advise her to use a\r\n             highly effective contraceptive method\r\n\r\n          9. Subjects must understand the nature of the study procedures and provide written\r\n             informed consent prior to any study-related procedures\r\n\r\n         10. Body weight 55 kg for men and 50 kg for women\r\n\r\n         11. Body mass index (BMI) <35 kg/m\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Subjects with neuropathic pain not a result of a surgical procedure as defined in\r\n             inclusion criterion 2\r\n\r\n          2. Subjects with any other coexisting pain that cannot be discriminated from\r\n             post-surgical neuropathic pain, in the opinion of the subject or clinician\r\n\r\n          3. Subjects diagnosed with chronic post-surgical neuropathic pain with a disease duration\r\n             exceeding 4 years\r\n\r\n          4. Inability to participate in the study, in the opinion of the investigator, because of,\r\n             for example, severe brain damage, language barrier, dementia, or other clinically\r\n             significant or unstable conditions\r\n\r\n          5. Subjects using adjuvant chemotherapy or radiotherapy; adjuvant therapies must have\r\n             been finished at least 4 weeks prior to the run-in period (Day -14)\r\n\r\n          6. Creatinine clearance <60 mL/min using the Cockcroft-Gault formula\r\n\r\n          7. White blood cell count <2500/mm; neutrophil count <1500/mm; platelet count <100 x\r\n             103/mm\r\n\r\n          8. Heart rate <50 or >100 beats per minute; systolic blood pressure <100 or >140 mmHg;\r\n             diastolic blood pressure <50 or >90 mmHg\r\n\r\n          9. A history of multiple drug allergies\r\n\r\n         10. History or presence of alcohol or drug abuse\r\n\r\n         11. Subjects using strong opioids (e.g. a Morphine Equivalent Dose [MED] >80 mg/day)\r\n\r\n         12. Positive test for drugs of abuse at Day -7\r\n\r\n         13. Evidence of depression and/or a score of 11 on the HADS depression subscale\r\n\r\n         14. Psychiatric disease in the past 5 years\r\n\r\n         15. History of any liver disease within the last 6 months, or migraine, or kidney\r\n             dysfunction or disease (e.g. estimated glomerular filtration rate [eGFR] 30 mL/min\r\n             per 1.73 m)\r\n\r\n         16. Clinically significant gastrointestinal conditions, likely interfering with the study\r\n             medication, study procedures or the outcome of the study\r\n\r\n         17. Positive test for human immunodeficiency virus (HIV)\r\n\r\n         18. Positive test for hepatitis B surface antigen (HBsAg), hepatitis B core antibody\r\n             (HBcAb), hepatitis C antibody and/or HIV1/HIV2 antibody at Screening\r\n\r\n         19. Participation of subject in an interventional clinical study within 1 month or, if\r\n             applicable, 5 half-lives of the IMP, whatever is longer, before Screening or during\r\n             participation in this study\r\n\r\n         20. Previous enrolment in this clinical study\r\n\r\n         21. Known hypersensitivity to the active substance or any of the excipients of the IMP or\r\n             the rescue medication\r\n\r\n         22. Subjects dependent (as an employee or relative) on the sponsor or investigator\r\n\r\n         23. Subjects committed to an institution by virtue of an order issued either by the\r\n             judicial or the administrative authorities\r\n\r\n         24. Legal incapacity or limited legal capacity\r\n\r\n        Randomization criteria\r\n\r\n          1. At least 5 daily pain assessments in the baseline week prior to randomization, with a\r\n             mean score on the PI-NRS 4 and 9. Differences between the baseline daily pain scores\r\n             on the PI-NRS must be 50%.\r\n\r\n          2. For female subjects of childbearing potential: negative pregnancy test in urine on Day\r\n             1.\r\n      ","sponsor":"Algiax Pharmaceuticals GmbH","sponsor_type":"Industry","conditions":"Peripheral Post-surgical Neuropathic Pain","interventions":[{"intervention_type":"Drug","name":"Drug: AP-325","description":"During the 10-day double-blind treatment period (Days 1 to 10), subjects will take 4 capsules of the IMP orally once daily in the morning before breakfast."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"During the 10-day double-blind treatment period (Days 1 to 10), subjects will take 4 capsules of the IMP orally once daily in the morning before breakfast."}],"outcomes":[{"outcome_type":"secondary","measure":"Incidence of abnormal ECG readings","time_frame":"Baseline, Day 3, 10 and 36","description":"Abnormal 12 lead ECG readings will be evaluated"},{"outcome_type":"secondary","measure":"Incidence of abnormal laboratory test results","time_frame":"Baseline, Day 3, 10, 15 and 36","description":"Abnormal laboratory test results will be evaluated"},{"outcome_type":"primary","measure":"Change from Baseline to Day 10 in the 5-day average pain intensity score based on the Pain Intensity Numerical Rating Scale (PI-NRS; ranges from \"no pain\" = 0 to \"the worst possible pain\" = 10; the lower the score, the better the outcome)","time_frame":"Baseline to Day 10","description":"The 5-day average pain intensity score based on the Pain Intensity Numerical Rating Scale (PI-NRS) will be assessed to investigate the efficacy of repeat oral dosing of AP-325"},{"outcome_type":"secondary","measure":"Longitudinal analysis of the 5-day average PI-NRS score (ranges from \"no pain\" = 0 to \"the worst possible pain\" = 10; the lower the score, the better the outcome) over time from Baseline until Day 35","time_frame":"Baseline to Day 35","description":"The 5-day average PI-NRS score will be assessed to investigate the long-lasting efficacy of repeat oral dosing of AP-325 on neuropathic pain over the entire study duration"},{"outcome_type":"secondary","measure":"Changes from Baseline in the 5-day average PI-NRS score (change can be in the range of 0 to 10; the bigger the change towards lower PI-NRS scores, the better the outcome) (from Baseline to Day 5, 15, 20, 25, 30 and 35)","time_frame":"Baseline to Day 5, 15, 20, 25, 30 and 35","description":"The 5-day average PI-NRS score will be assessed"},{"outcome_type":"secondary","measure":"Responder rate: proportion of subjects who have a ≥30% reduction in the 5-day average PI-NRS score (in the range of 0 to 10; the bigger the change towards lower scores, the better the outcome) relative to Baseline (on Days 5, 10, 15, 25 and 35)","time_frame":"Baseline to Day 5, 10, 15, 25 and 35","description":"The responder rate will be compared between treatments on Day 5, 10, 15, 25 and 35"},{"outcome_type":"secondary","measure":"Responder rate: proportion of subjects who have a ≥50% reduction in the 5-day average PI-NRS score (in the range of 0 to 10; the bigger the change towards lower scores, the better the outcome) relative to Baseline (on Days 5, 10, 15, 25 and 35)","time_frame":"Baseline to Day 5, 10, 15, 25 and 35","description":"The responder rate will be compared between treatments on Day 5, 10, 15, 25 and 35"},{"outcome_type":"secondary","measure":"Proportion of subjects who \"much improved\" or \"very much improved\" relative to Baseline on the patient global impression of change (PGIC) on Days 3, 10, 15, and 36","time_frame":"Days 3, 10, 15, and 36","description":"The PGIC will be dichotomized into treatment success (i.e. scoring 'much improved' or 'very much improved')."},{"outcome_type":"secondary","measure":"Changes from Baseline in the neuropathic pain evaluation using the neuropathic pain symptom inventory (NPSI; ranges from \"no pain\" = 0 to \"the worst possible pain\" = 120; the lower the score, the better) questionnaire on Days 3, 10, 15, and 36","time_frame":"Baseline, Day 3, 10, 15 and 36","description":"Neuropathic pain symptom inventory (NPSI) questionnaire to assess the neuropathic pain of the patients"},{"outcome_type":"secondary","measure":"Changes from Baseline in the 5-day average daily sleep interference scale (DSIS; ranges from \"pain does not interfere with sleep\" = 0 to \"pain completely interferes with sleep\" = 10) score (from Baseline to Day 5, 10, 15, 25 and 35)","time_frame":"Baseline to Day 5, 10, 15, 25 and 35","description":"The 5-day average daily sleep interference scale (DSIS) score will be assessed"},{"outcome_type":"secondary","measure":"Changes from Baseline in the anxiety and depression assessment using the hospital anxiety and depression scale (HADS; subscales range from 0 to 21, with higher values indicating higher anxiety or depression; the lower the score) on Days 10 and 36","time_frame":"Baseline, Day 10 and 36","description":"The hospital anxiety and depression scale (HADS) to assess the anxiety and depression of the patients"},{"outcome_type":"secondary","measure":"Time to first use of rescue medication after randomization","time_frame":"A priori specification not possible, between Day 1 until Day 36","description":"The time to first use of rescue medication after randomization will be analyzed"},{"outcome_type":"secondary","measure":"Total amount of rescue medication use (in mg per day) after randomization","time_frame":"A priori specification not possible, between Day 1 until Day 36","description":"The total amount of rescue medication (i.e. the total mg of rescue medication per day will be tabulated"},{"outcome_type":"secondary","measure":"Proportion of subjects classified as treatment failure","time_frame":"A priori specification not possible, between Day1 and Day 36","description":"Proportion of subjects classified as treatment failure at least once after randomization will be tabulated"},{"outcome_type":"secondary","measure":"Time to classification as treatment failure after randomization","time_frame":"A priori specification not possible, between Day1 and Day 36","description":"Time to first classification as treatment failure after randomization will be analyzed"},{"outcome_type":"secondary","measure":"Incidence, severity and seriousness of treatment-emergent adverse events (TEAEs)","time_frame":"A priori specification not possible, between Day1 and Day 36","description":"All TEAEs occurring during the clinical trial will be registered, documented and evaluated"},{"outcome_type":"secondary","measure":"Incidence of abnormal physical examinations","time_frame":"Baseline, Day 3, 10, 15 and 36","description":"Abnormal physical examination results will be evaluated and reported as AEs"},{"outcome_type":"secondary","measure":"Changes from Baseline in vital signs: Systolic and diastolic blood pressure","time_frame":"Baseline, Day 1, 3, 10, 15 and 36","description":"Systolic and diastolic blood pressure will be measured"},{"outcome_type":"secondary","measure":"Changes from Baseline in vital signs: Heart rate","time_frame":"Baseline, Day 1, 3, 10, 15 and 36","description":"Heart rate will be measured"},{"outcome_type":"secondary","measure":"Changes from Baseline in vital signs: Respiratory rate","time_frame":"Baseline, Day 1, 3, 10, 15 and 36","description":"Respiratory rate will be measured"},{"outcome_type":"secondary","measure":"Changes from Baseline in vital signs: Aural body temperature","time_frame":"Baseline, Day 1, 3, 10, 15 and 36","description":"Aural body temperature will be measured"},{"outcome_type":"secondary","measure":"Changes from Baseline in body weight","time_frame":"Baseline, Day 10 and 36","description":"Body weight will be evaluated"},{"outcome_type":"secondary","measure":"Plasma concentrations of AP-325 at 1 hour post-dose on Days 1 and 10; pre-dose on Days 3 and 10; and on Day 36","time_frame":"Days 1, 3, 10 and 36","description":"Plasma concentrations of AP-325 will be evaluated"},{"outcome_type":"secondary","measure":"Accumulation of Ctrough from Day 3 to Day 10","time_frame":"Day 3 and 10","description":"Plasma concentrations of AP-325 will be evaluated"},{"outcome_type":"secondary","measure":"Correlation between Ctrough-ss (Day 10) and the change from Baseline to Day 10 in the 5-day average pain intensity score based on the PI-NRS","time_frame":"Baseline to Day 10","description":"AP-325 concentration-effect relationships will be evaluated"},{"outcome_type":"secondary","measure":"Correlation between CYP2C9 genotype and the metabolism of AP-325 (optional)","time_frame":"Day 3","description":"The effect of CYP2C9 polymorphisms (determined by CYP2C9 genotyping) on the plasma concentration of AP-325 will be evaluated"}]}
{"nct_id":"NCT04833673","start_date":"2020-06-22","phase":"N/A","enrollment":80,"brief_title":"The Effects of Relaxation Techniques on Pain, Fatigue and Kinesiophobia in Multiple Sclerosis Patients: A Three Arms Randomized Trial","official_title":"The Effects of Relaxation Techniques on Pain, Fatigue and Kinesiophobia in Multiple Sclerosis Patients: A Three Arms Randomized Trial","primary_completion_date":"2020-12-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2021-03-15","last_update":"2021-04-06","description":"Even though, current treatments including IVIG, corticosteroids, biological agents can provide positive effects on MS symptoms, MS cannot be cured completely today. Therefore, in addition to the available medical treatment options, patients may tend towards complementary and integrative therapies. Relaxation techniques are one of the non-pharmacological and side-effect-free therapy options that are currently used to alleviate the symptoms of many different chronic diseases. Progressive muscle relaxation exercise (PMR) and Benson relaxation technique (BRT) are two common types of relaxation techniques recommended for symptom management in chronic diseases owing to simple to learn and apply compared to other complementary and integrative methods for patients. PMR is uncomplicated and low-cost method, originally designed by Jacobson (1938), which helps individuals to feel calmer through consecutive muscle tension and relaxation of a muscle group. This method can relieve muscle tension, facilitate sleep, and reduce severity of pain and fatigue. There are studies in the literature reporting the positive effects of PMR on fatigue, sleep quality, quality of life, anxiety and stress in MS patients. One of these techniques which is well tolerated is BRT, designed by Herbert Benson in the 1970s as a nonpharmacologic and behavioral method. This technique led to relaxation using mental imagery and mediation. BRT creates a relaxation influence in the body by decreasing the sympathetic nervous system activity and increasing the parasympathetic nervous system activity. There are few studies in the literature reporting that BRT is beneficial on pain and fatigue in MS patients.To the best of our knowledge, there is no study on the impact of relaxation techniques on pain, fatigue and kinesophobia in MS patients. The aim of this study was to examine and compare the effects of PMR and BRT on abovementioned symptoms in MS patients.","other_id":"333","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","intervention_model_description":"A Three Arms Randomized Trial","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  over the age of 18\r\n\r\n          -  having relapsing-remitting MS type and not had an attack during the study\r\n\r\n          -  not receiving any other complementary and integrative therapy during the research,\r\n\r\n          -  with an Expanded Disability Status Scale score of 5.5 and below,\r\n\r\n          -  volunteer to participate in study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  having physical or mental health problems that can interfere with communication\r\n\r\n          -  having heart failure, COPD, asthma disease, renal failure, musculoskeletal problem\r\n             such as fracture, plaster cast, amputation, fibromyalgia, ankylosing spondylitis,\r\n             rheumatoid arthritis, deep anemia (hmg <8 mg / dl) or oncological diagnoses\r\n\r\n          -  not having undergone any surgical operation in the last 3 months\r\n      ","sponsor":"Hacettepe University","sponsor_type":"Other","conditions":"Multiple Sclerosis, Relapsing-Remitting|Pain, Chronic|Fatigue Syndrome, Chronic|Kinesiophobia","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: PMR: Progressive Muscle Relaxation","description":"tensing and relaxing the body muscles accompanied with deep breathing"},{"intervention_type":"Behavioral","name":"Behavioral: BRT:Benson Relaxation Technique","description":"relaxation using mental imagery and mediation"}],"outcomes":[{"outcome_type":"primary","measure":"Fatigue","time_frame":"12 weeks","description":"Fatigue Severity Scale"},{"outcome_type":"secondary","measure":"Chronic Pain","time_frame":"12 weeks","description":"VAS"},{"outcome_type":"secondary","measure":"Kinesiophobia","time_frame":"12 weeks","description":"Tampa Scale for Kinesophobia"}]}
{"nct_id":"NCT04416282","start_date":"2020-06-22","phase":"N/A","enrollment":140,"brief_title":"Efficacy of Early Terlipressin Plus Albumin Therapy in Comparison to Standard Treatment for HRS-AKI in Acute-on-chronic Liver Failure.","official_title":"Efficacy of Early Terlipressin Plus Albumin Therapy in Comparison to Standard Treatment for HRS-AKI in Acute-on-chronic Liver Failure- A Randomized Open Label Study.","primary_completion_date":"2022-06-10","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-06-10","last_update":"2020-08-04","description":"Acute on chronic liver failure (ACLF) is a distinct entity where, because of severe acute hepatic injury, a rapid loss of liver function develops in a patient with previous chronic liver disease(4). These patients have severe hepatic dysfunction, and outcome is defined by functional hepatic reserve and extent of extra-hepatic organ failures(5). Renal failure is a frequent extra-hepatic organ failure, and its presence is an independent prognostic marker for mortality(12). The pathophysiological basis of renal dysfunction in patients with ACLF is different compared to those with decompensated cirrhosis (DC)(6). Systemic inflammation is the hallmark of ACLF, characterized by a cytokine storm wherein there is an increase in both pro- and anti-inflammatory cytokines, such as interleukin (IL)-6, IL-8, IL-1, and IL-10, leading to circulatory dysfunction and organ failure(3). These patients therefore have a higher incidence and progression of acute kidney injury (AKI). Diagnosis of HRS-AKI in ACLF currently requires 48 h of volume repletion with albumin and diuretic withdrawal. Therefore waiting for 48 hours to start treatment with terlipressin can be associated with worsening of AKI stage, worsening of ACLF stage and thereby suboptimal treatment response and high mortality despite treatment response. Therefore early initiation of terlipressin as continuous infusion after volume repletion with IV albumin in ACLF-AKI is safe and prevents AKI progression by splanchnic vasoconstriction and improved renal perfusion.","other_id":"ILBS-ACLF-04","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age 18-65 years\r\n\r\n          2. ACLF as per APASL criteria\r\n\r\n          3. AKI at admission as defined by ICA-AKI criteria\r\n\r\n          4. AKI stage 2/3 at 12 hour of admission\r\n\r\n        Exclusion Criteria:\r\n\r\n        -\r\n\r\n        At Admission:\r\n\r\n          -  Age <18 years\r\n\r\n          -  Patients on renal replacement therapy (RRT)\r\n\r\n          -  Post renal or liver transplantation\r\n\r\n          -  History of CAD, ischemic cardiomyopathy, PVD, ventricular arrhythmia\r\n\r\n          -  Decompensated cirrhosis not fulfilling ACLF criteria\r\n\r\n          -  Cirrhotics with AKI managed as outpatients\r\n\r\n          -  Grade III/IV HE or Shock requiring inotropes or patients on mechanical ventilator at\r\n             time of randomization\r\n\r\n          -  In-hospital new AKI\r\n\r\n          -  Active urinary sediments - 2+ albumin or above, dysmorphic RBCs\r\n\r\n          -  Known CKD, obstructive uropathy\r\n\r\n          -  Lack of informed consent\r\n\r\n          -  Prior intolerance or S/E to Terlipressin or albumin\r\n\r\n        At 12 Hour before randomization:\r\n\r\n         Regression of AKI (>0.3 mg/dl) above baseline after IV albumin (20% 40 gm) + IV\r\n        Crystalloids 500 ml therapy for 12 hours\r\n      ","sponsor":"Institute of Liver and Biliary Sciences, India","sponsor_type":"Other","conditions":"Acute-On-Chronic Liver Failure|Hepatorenal Syndrome|Acute Kidney Injury","interventions":[{"intervention_type":"Drug","name":"Drug: Terlipressin","description":"Injection terlipressin 2 mg/24 hours infusion"},{"intervention_type":"Biological","name":"Biological: Albumin","description":"i/v albumin 1g/Kg/day"}],"outcomes":[{"outcome_type":"primary","measure":"Acute Kidney Injury reversal by day 7 in both groups","time_frame":"Day 7"},{"outcome_type":"secondary","measure":"Mortality in both groups","time_frame":"Day 28"},{"outcome_type":"secondary","measure":"Mortality in both groups","time_frame":"Day 90"},{"outcome_type":"secondary","measure":"Progression or resolution of Organ failures","time_frame":"Day 90"},{"outcome_type":"secondary","measure":"Adverse Events in both groups","time_frame":"Day 90"}]}
{"nct_id":"NCT04421976","start_date":"2020-06-21","phase":"N/A","enrollment":55,"brief_title":"Driving Pressure in Neurosurgery","official_title":"Driving Pressure for Early Postoperative Redistribution of Pulmonary Ventilation in Neurosurgery : A Prospective Randomized Controlled Trial","primary_completion_date":"2021-04-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2021-07-01","last_update":"2021-07-06","description":"The effect of driving pressure (DP)-guided positive end expiratory pressure (PEEP) on early postoperative pulmonary ventilation is to be determined for patients undergoing neurosurgery. Patients are recruited to receive volume controlled ventilation with either a fixed PEEP (5cmH2O) or DP titrated PEEP. Early postoperative regional distribution of lung ventilation, expressed as global inhomogeneity (GI) is evaluated by electrical impedance tomography (EIT), a noninvasive, radiation free modality. Center of ventilation (COV) by EIT, as well as the lung ultrasonographyLUS), perioperative ventilatory parameters, arterial oxygenation index (PaO2/FiO2) , serum indicators and postoperative pulmonary complications are secondary outcome variables.","other_id":"DP-Neurosurgery","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Informed consent has been obtained\r\n\r\n          -  Elective neurosurgery\r\n\r\n          -  Expected ventilation duration > 2 hours\r\n\r\n          -  Scheduled to be extubated in the operation\r\n\r\n          -  American Society of Anesthesiologists (ASA) physical status >2\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Mechanical ventilation of > 1 hour within the last 2 weeks before surgery\r\n\r\n          -  Dysphagia resulting from preoperative cranial nerve damage\r\n\r\n          -  Body mass index  35 kg/m2\r\n\r\n          -  Acute respiratory failure (pneumonia, acute lung injury or acute respiratory distress\r\n             syndrome)\r\n\r\n          -  Emergency surgery\r\n\r\n          -  Severe cardiac disease\r\n\r\n          -  Progressive neuromuscular illness\r\n\r\n          -  Pregnancy\r\n\r\n          -  Refusal to participate\r\n\r\n          -  Contradicted to EIT scan or lung ultrasound scan\r\n      ","sponsor":"Capital Medical University","sponsor_type":"Other","conditions":"Neurosurgery","interventions":[{"intervention_type":"Procedure","name":"Procedure: PEEP","description":"Driving pressure (DP) is calculated as \"plateau pressure - PEEP\". 10min after position adjustment, PEEP is increased from 2 to 10 cm H2O incrementally. Each PEEP level is maintained for 10 respiratory cycles, with DP in the last cycle recorded. Then the PEEP level producing the lowest DP will be identified and maintained intraoperatively."}],"outcomes":[{"outcome_type":"primary","measure":"early postoperative overall spatial distribution of pulmonary ventilation","time_frame":"immediately after extubation","description":"global inhomogeneity index (GI): overall degree of spatial heterogeneity of ventilation. GI is measured by electrical impedance tomography (EIT). A smaller GI index represents a more homogeneous distribution, and a larger GI index indicates a more inhomogeneous ventilation."},{"outcome_type":"other","measure":"Melbourne Group Scale version 2 (MGS-2)","time_frame":"within the first 3 days after surgery","description":"Melbourne Group Scale version 2 (MGS-2): Temperature >38°C; White cell count >11.2 or use of respiratory antibiotics; Physician diagnosis of pneumonia or chest infection; Chest X-ray findings of atelectasis/consolidation; Production of purulent (yellow/green) sputum different from preoperative sputum; Positive results upon sputum microbiological analysis; oxygen saturation by pulse oximetry (SpO2)<90% in ambient air; Re-admission to or prolonged stay (>36 h) in the intensive care unit/high dependency unit for respiratory problems. A postoperative pulmonary complication (PPC) was diagnosed if 4 or more of the 8 factors were present."}]}
{"nct_id":"NCT04566614","start_date":"2020-06-18","enrollment":112,"brief_title":"Preventing Viral Pandemic Associated Risk of Cancer Death Using Less Invasive Diagnostic Tests- Liquid Biopsies","official_title":"Preventing Viral Pandemic Associated Risk of Cancer Death Using Less Invasive Diagnostic Tests- Liquid Biopsies","primary_completion_date":"2021-12-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2022-12-31","last_update":"2020-09-28","description":"The purpose of this study is to investigate the feasibility of using ctDNA to support cancer diagnosis and risk stratification where invasive aerosol generating testing (and/or tissue biopsy) is challenging due to infection risk, technical impracticalities and resource limitations, such as during the COVID-19 pandemic and the subsequent recovery period.","other_id":"CCR 5292","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients with suspected malignancy for whom invasive biopsy for definitive histological\r\n        diagnosis is challenging either due to COVID-19-related resource limitations, infection\r\n        control or technical feasibility will be considered for this study","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Participants aged 18 years old\r\n\r\n          -  Patients with suspected malignancies of early stage colorectal cancer (FIT\r\n             intermediate and high risk), early and late stage pancreatic cancer, biliary tract\r\n             cancer, gastro-intestinal stromal tumours, lung cancer or bladder cancer, without a\r\n             definitive histological diagnosis (including those with inconclusive biopsy result) or\r\n\r\n          -  Patients with histological diagnosis of lung cancer without adequate tissue for NHS\r\n             genomic test directory predictive biomarker testing\r\n\r\n          -  Ability to provide informed consent.\r\n\r\n          -  Patients with performance status suitable for oncological treatments (ECOG performance\r\n             status 0-2).\r\n\r\n        Exclusion criterion:\r\n\r\n         Patients with an established histological diagnosis adequate to support standard of care\r\n        treatment\r\n      ","sponsor":"Royal Marsden NHS Foundation Trust","sponsor_type":"Other","conditions":"Neoplasm, Colorectal|Neoplasm of Lung|Neoplasm, Bladder|Neoplasms Pancreatic|Biliary Tract Neoplasms|Gastro Intestinal Stromal Tumour","interventions":[{"intervention_type":"Other","name":"Other: ctDNA blood sampling","description":"Screening/baseline blood sample to be analysed for ctDNA"}],"outcomes":[{"outcome_type":"primary","measure":"ctDNA detection rate within different cancer types (and overall)","time_frame":"Throughout study completion, up to one year","description":"The primary endpoint, ctDNA detection rate, overall and within different cancer types will be presented as a proportion of patients with a positive ctDNA test out of those tested, with 90% confidence intervals"},{"outcome_type":"secondary","measure":"Proportion of patients with a positive ctDNA result which identified a diagnosis and/or commenced treatment","time_frame":"Throughout study completion, up to one year","description":"All secondary endpoints will be analysed in the patients diagnosed with suspected cancer, i.e. positive ctDNA result, unless stated. They will also be presented overall and by cancer type. The proportion of patients with positive ctDNA result which identified a diagnosis and/or commenced treatment will be presented as a proportion with 90% confidence intervals"},{"outcome_type":"secondary","measure":"Proportion of patients with a positive ctDNA result which assisted in prioritising invasive diagnostic tests","time_frame":"Throughout study completion, up to one year","description":"Proportion of patients with positive ctDNA result which assisted in prioritising invasive diagnostic tests will be presented as a proportion with 90% confidence intervals"},{"outcome_type":"secondary","measure":"The association of ctDNA result (positive versus negative) and the PREVAIL-imaging pathway scoring result","time_frame":"Throughout study completion, up to one year","description":"The association between ctDNA result (positive versus negative) and the PREVAIL-imaging pathway scoring result will be assessed descriptively by presenting cross-tabulations and relevant proportions"},{"outcome_type":"secondary","measure":"Estimation of the cost of liquid biopsy in lieu of tissue biopsy as compared to standard of care investigations and treatments prioritisation","time_frame":"Throughout study completion, up to one year","description":"Simple estimation of the cost of liquid biopsy in lieu of tissue biopsy as compared to standard of care investigations and treatments prioritisation will be performed"}]}
{"nct_id":"NCT04416464","start_date":"2020-06-15","enrollment":280,"brief_title":"Quality of Life and Patient-centered Outcomes After ICU Admission for COVID-19","official_title":"Quality of Life and Long-term Outcomes in Patients With Pneumonia Associated With SARS-Cov2 Infection, Survivors of Intensive Care Units: a Prospective Multicenter Cohort Study","primary_completion_date":"2021-07-31","study_type":"Observational","rec_status":"Active, not recruiting","completion_date":"2022-10-01","last_update":"2021-09-10","description":"Patients suffering from pneumonia due to SARS-CoV-2 infection, after admission to the Intensive Care Unit (ICU), are susceptible to development of various functional sequelae, increased risk of chronic diseases, increased mortality rates and existence of relevant impacts on their quality of life in the months and years that follow the ICU admission. The present study aims to assess the determinants of health-related quality of life and patient-centered long-term outcomes among patients recovered from SARS-COV-2 pneumonia, after discharge from the ICU, its determinants and predictors, in Portugal. It is a multicenter prospective cohort study of adult patients admitted at the ICU due to proven or suspected SARS-CoV-2 infection, included 90 days after discharge from the ICU. The primary outcome is one-year health-related quality of life assessed by the EQ-5D-3L. The secondary outcomes are all-cause mortality, rehospitalizations, return to work or study, the degree of dependence and functional capacity, symptoms of anxiety, depression and post-traumatic stress, level of physical activity and cognitive, renal and respiratory functions after ICU discharge. Investigators will collect data by means of structured telephone interviews, at a 12 months follow up period.","other_id":"QoL_ICU_COVID","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"Adult survivors of ICU admission and pneumonia due to proven or suspected SARS-CoV-2\r\n        infection.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Men and women aged 18 years and older\r\n\r\n          -  Admission to the intensive care unit (ICU)\r\n\r\n          -  Pneumonia due to proven or suspected SARS-CoV-2 infection\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Refusal to provide consent for the study by the patient or legal guardian\r\n\r\n          -  ICU length of stay less than 24 hours\r\n\r\n          -  Absence of telephone contact\r\n      ","sponsor":"Universidade do Porto","sponsor_type":"Other","conditions":"Quality of Life|Long-term Outcomes|Coronavirus Infection|Morality|Rehospitalization","interventions":[{"intervention_type":"Other","name":"Other: COVID-19 Pneumonia","description":"Pneumonia due to proven or suspected SARS-Cov-2 infection"}],"outcomes":[{"outcome_type":"primary","measure":"Health-related quality of life.","time_frame":"One-year (12 months) after ICU discharge.","description":"The outcome will be assessed using the Portuguese version of the Euroqol-5D-3L (EQ-5D3L) questionnaire. The utility score derived from the EQ5D-3L ranges from 0 (death) to 1 (perfect health)."},{"outcome_type":"secondary","measure":"Length of stay at the ICU.","time_frame":"The outcome will be assessed 3 months after ICU discharge (at the participant enrollment).","description":"Length of stay at the ICU."},{"outcome_type":"secondary","measure":"Incidence of all-cause mortality","time_frame":"The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.","description":"Incidence of all-cause mortality."},{"outcome_type":"secondary","measure":"Rehospitalization.","time_frame":"The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.","description":"Rehospitalization."},{"outcome_type":"secondary","measure":"Percentage of long-term ventilatory support need.","time_frame":"The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.","description":"Percentage of patients requiring oxygen therapy, non-invasive ventilation, or mechanical ventilation."},{"outcome_type":"secondary","measure":"Percentage of renal replacement therapy need.","time_frame":"The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.","description":"Percentage of patients requiring any kind of renal replacement therapy."},{"outcome_type":"secondary","measure":"Symptoms of anxiety and depression.","time_frame":"The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.","description":"The outcome will be assessed using the Hospital Anxiety and Depression Scale (anxiety and depression scores range from 0 to 21, with higher scores indicating worse symptoms)."},{"outcome_type":"secondary","measure":"Score of functional independence.","time_frame":"The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.","description":"The outcome will be assessed using the Lawton & Brody Instrumental Activities of Daily Living Scale, a score of instrumental activities of daily living (the score ranges from 0 to 8, with higher scores indicating less dependence)."},{"outcome_type":"secondary","measure":"Score of cognitive function.","time_frame":"The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.","description":"The outcome will be assessed using the The Montreal Cognitive Assessment (MoCA). The score ranges from 0 to 30, in 8 domains, with higher scores indicating worse symptoms."},{"outcome_type":"secondary","measure":"Percentage of major cardiac events.","time_frame":"The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.","description":"Percentage of major cardiac events."},{"outcome_type":"secondary","measure":"Score of Chronic obstructive pulmonary disease (COPD)","time_frame":"The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.","description":"Score of Chronic obstructive pulmonary disease (COPD) assessed using the Portuguese version of the Clinical COPD Questionnaire (CCQ). The Clinical COPD, consisting of 10 items (each scored between 0 and 6), divided into three domains (symptoms, functional, mental). The total score is calculated by summing the scores of the individual items and dividing by 10 (the number of individual items) giving a total score between 0 and 6 with higher scores representing worse scenario."},{"outcome_type":"secondary","measure":"Symptoms of posttraumatic stress disorder","time_frame":"The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.","description":"The outcome will be assessed using the Impact Event Scale-Revised (the score ranges from 0 to 88, with higher scores indicating worse symptoms)."},{"outcome_type":"secondary","measure":"Utility score of health-related quality of life at 3, 6, and 9 months.","time_frame":"The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.","description":"The outcome will be assessed using the Portuguese version of the Euroqol-5D-3L (EQ-5D3L) questionnaire. The utility score derived from the EQ5D-3L ranges from 0 (death) to 1 (perfect health)."},{"outcome_type":"secondary","measure":"Score of self-rated health.","time_frame":"The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.","description":"The outcome will be assessed using the visual analogue scale of the Portuguese version of the Euroqol-5D-3L questionnaire (EQ-VAS; score range from o to 100, with higher scores indicating better self-rated health)."}]}
{"nct_id":"NCT04106219","start_date":"2020-06-11","phase":"Phase 1","enrollment":71,"brief_title":"A Study of LY3295668 Erbumine in Participants With Relapsed/Refractory Neuroblastoma","official_title":"A Phase 1 Study of Aurora Kinase A Inhibitor LY3295668 Erbumine as a Single Agent and in Combination in Patients With Relapsed/Refractory Neuroblastoma","primary_completion_date":"2024-04-17","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2025-04-18","last_update":"2021-08-18","description":"The reason for this study is to see if the study drug LY3295668 erbumine is safe in participants with relapsed/refractory neuroblastoma.","other_id":"17295","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":2,"maximum_age":21,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Participants must have relapsed/refractory neuroblastoma and have active disease in at\r\n             least one site: bone, bone marrow or soft tissue. Participants must be able to submit\r\n             an archival sample of tissue.\r\n\r\n          -  Participants must be able to swallow capsules.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Participants must not have had an allogeneic hematopoietic stem cell, bone marrow, or\r\n             solid organ transplant.\r\n\r\n          -  Participants must not have untreated tumor that has spread to the brain or spinal\r\n             cord.\r\n\r\n          -  Participants must not have a serious active disease other than neuroblastoma.\r\n\r\n          -  Participants must not have a condition affecting absorption.\r\n\r\n          -  Participants must not have had prior aurora kinase inhibitor exposure.\r\n\r\n          -  Participants must not have a known allergy to the study treatment.\r\n\r\n          -  Participants must not have symptomatic human immunodeficiency virus (HIV) infection or\r\n             symptomatic activated/reactivated hepatitis A, B, or C.\r\n      ","sponsor":"Eli Lilly and Company","sponsor_type":"Industry","conditions":"Neuroblastoma","interventions":[{"intervention_type":"Drug","name":"Drug: LY3295668 Erbumine","description":"Administered orally."},{"intervention_type":"Drug","name":"Drug: Topotecan","description":"Administered IV."},{"intervention_type":"Drug","name":"Drug: Cyclophosphamide","description":"Administered IV."}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants with Dose Limiting Toxicities (DLTs)","time_frame":"Baseline through Cycle 2 (28 Day Cycle)","description":"Number of Participants with DLTs"},{"outcome_type":"primary","measure":"Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)","time_frame":"Baseline through Measured Progressive Disease (Estimated up to 5 Years)","description":"ORR"},{"outcome_type":"primary","measure":"Duration of Response (DoR)","time_frame":"Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 5 Years)","description":"DoR"},{"outcome_type":"secondary","measure":"Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668","time_frame":"Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles)","description":"PK: AUC of LY3295668"},{"outcome_type":"secondary","measure":"PK: AUC of LY3295668 in Combination with Topotecan and Cyclophosphamide","time_frame":"Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles)","description":"PK: AUC of LY3295668 in Combination with topotecan and cyclophosphamide"},{"outcome_type":"secondary","measure":"Best Overall Response (BOR): Percentage of Participants with CR, PR, Stable Disease (SD), or Progressive Disease (PD)","time_frame":"Baseline to Date of Objective Disease Progression (Estimated up to 5 Years)","description":"BOR"},{"outcome_type":"secondary","measure":"Progression-Free Survival (PFS)","time_frame":"Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 5 Years)","description":"PFS"},{"outcome_type":"secondary","measure":"Overall Survival (OS)","time_frame":"Baseline to Date of Death from Any Cause (Estimated up to 6 Years)","description":"OS"}]}
{"nct_id":"NCT04677933","start_date":"2020-06-03","phase":"Phase 1","enrollment":30,"brief_title":"A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Multiple Subcutaneous Doses of OLP-1002","official_title":"A Phase 1b, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Multiple Subcutaneous Doses of OLP-1002 in Patients Who Have Pain Due to Moderate to Severe Osteoarthritis in a Hip and/or Knee Joint","primary_completion_date":"2020-12-22","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-12-22","last_update":"2020-12-24","description":"This is a Phase 1b, randomised, double-blind, placebo-controlled, parallel study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of multiple SC doses of OLP-1002 in patients who have pain due to moderate to severe osteoarthritis (OA) in a hip and/or knee joint. The study consists of: - Screening period: up to 14 days (defined as Day -23 to -9) - Washout period: 5 days ( 1 day) (defined as Day -8 to -4) - Baseline period: 3 days ( 1 day) (defined as Day -3 to -1, where Day -1 is the day before dosing) - Treatment period: 15 days ( 1 day) (defined as Day 1 to 15, where Day 1 is the day of first dosing) - Follow-up period: 30 days ( 5 days) (defined as Day 16 to 45, assuming Day 15 is the day of the last dose) Up to 30 patients will be enrolled in the study and will be randomised in the ratio 1:1:1 to the following arms: - Arm A: 10 patients will receive 5 g twice-weekly (BIW) OLP-1002 - Arm B: 10 patients will receive 10 g BIW OLP-1002 - Arm C: 10 patients will receive Placebo BIW","other_id":"OLP-1002-001B","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":35,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Male or female aged greater than or equal to 35 years to lesser than or equal to 65\r\n             years as of the date of study enrolment;\r\n\r\n          2. Patients must be willing and able to provide written informed consent after the nature\r\n             of the study has been explained and prior to the commencement of any study procedures;\r\n\r\n          3. Patients have a BMI greater than or equal to 18 and less than 40 kg/m2 at Screening;\r\n\r\n          4. Patients have pain in (a) hip or knee joint/s, every day for at least one month during\r\n             the three months prior to Screening;\r\n\r\n          5. Patients have a diagnosis of moderate to severe OA of the index hip or knee: moderate\r\n             to severe osteoarthritis, based on American College of Rheumatology (ACR) criteria\r\n             with Kellgren Lawrence X-ray grade of at least 3 as diagnosed by the radiologist;\r\n\r\n          6. Patients with WOMAC Total Pain subscale score of  10 in the index hip or knee at\r\n             Screening;\r\n\r\n          7. Patients who are willing to discontinue all non-study pain medications except for\r\n             permitted rescue pain medication for the duration of the study;\r\n\r\n          8. Patients agree to maintain their usual levels of activity throughout the course of the\r\n             study and until End of Study (EOS) (Day 45);\r\n\r\n          9. Patients who are willing to abstain from all other intra-articular treatments of the\r\n             joint and any joint surgery while in the study and until EOS (Day 45);\r\n\r\n         10. Patients having clear injection sites, although parts of the body have tattoos;\r\n\r\n         11. Patients who are willing and able to comply with study procedures, including the\r\n             recording of daily questionnaires;\r\n\r\n         12. Females must be non-pregnant and non-lactating, and must use acceptable, highly\r\n             effective double contraception from screening until 90 days after the last dose of\r\n             study drug. Double contraception is defined as a condom AND one other form of the\r\n             following:\r\n\r\n               1. Established hormonal contraception (for example, approved oral contraceptive\r\n                  pills (OCPs), long-acting implantable hormones, injectable hormones);\r\n\r\n               2. A vaginal ring or an intrauterine device (IUD); or\r\n\r\n               3. Documented evidence of surgical sterilisation at least 6 months prior to\r\n                  screening (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, or\r\n                  bilateral oophorectomy for women or vasectomy for men [with appropriate\r\n                  post-vasectomy documentation of the absence of sperm in semen] provided the male\r\n                  partner is a sole partner)\r\n\r\n               4. Women not of childbearing potential must be post-menopausal for 12 months.\r\n                  Post-menopausal status will be confirmed through testing of follicle-stimulating\r\n                  hormone (FSH) levels  40 IU/mL at Screening for amenorrhoeic female patients.\r\n                  Females who are abstinent from heterosexual intercourse will also be eligible.\r\n\r\n               5. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation\r\n                  methods) and withdrawal are not considered highly effective methods of birth\r\n                  control. A patient's complete abstinence for the duration of the study and for 90\r\n                  days after the last study treatment is acceptable.\r\n\r\n               6. Female patients who are in a same-sex relationships are not required to use\r\n                  contraception.\r\n\r\n               7. Males must be surgically sterile (greater than 30 days since vasectomy with no\r\n                  viable sperm), abstinent, or if engaged in sexual relations with a women of child\r\n                  bearing potential (WOCBP), the patient and his partner must be surgically sterile\r\n                  (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral\r\n                  oophorectomy) or using an acceptable, highly effective contraceptive method from\r\n                  Screening until 90 days after the last dose of study drug. Acceptable methods of\r\n                  contraception include the use of condoms and the use of an effective\r\n                  contraceptive for the female partner that includes: OCPs, long acting implantable\r\n                  hormones, injectable hormones, a vaginal ring or an IUD. Patients with same-sex\r\n                  partners (abstinence from penile-vaginal intercourse) are eligible when this is\r\n                  their preferred and usual lifestyle;\r\n\r\n         13. WOCBP must have a negative pregnancy test at Screening and Day 1 and be willing to\r\n             have additional pregnancy tests as required throughout the study;\r\n\r\n         14. Males must not donate sperm for at least 90 days after the last dose of study drug.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Any of the following:\r\n\r\n               -  QTcF greater than 450 ms confirmed by repeat ECG measurement\r\n\r\n               -  QRS duration greater than 110 ms confirmed by repeat ECG measurement\r\n\r\n               -  PR interval greater than 220 ms confirmed by repeat ECG measurement\r\n\r\n               -  Findings which would make QTc measurements difficult or QTcF data uninterpretable\r\n\r\n               -  History of additional risk factors for torsades de pointes (e.g., heart failure\r\n                  (class III/IV according to the New York Heart Association [NYHA]), hypokalaemia,\r\n                  family history of long QT syndrome)\r\n\r\n          2. Intraarticular treatment injections (including but not limited to corticosteroids,\r\n             hyaluronic acid, platelet rich plasma, BOTOX, local anaesthetics) within 3 months\r\n             prior to the Screening period\r\n\r\n          3. Patients who are unable or unwilling to cease the use of all pain medications,\r\n             prescription, over-the-counter and otherwise, as of the first day of the study Washout\r\n             Period and until after Day 45 of the study. This includes all opioid and\r\n             anti-inflammatory medications. This excludes the use of paracetamol provided that a\r\n             patient is able and willing to utilise a maximum of 2 g of paracetamol per 24-hour\r\n             period as of the first day of the study Washout Period and until after Day 45 of the\r\n             study, unless the PI has approved an increased dose up to 4 g;\r\n\r\n          4. Use or intend to use TENS machine during the study period, i.e. from screening until\r\n             after Day 45 of the study;\r\n\r\n          5. Any of the following laboratory abnormalities within 14 days of the first treatment\r\n             day:\r\n\r\n               -  Platelet count less than 100,000 cells/mm3\r\n\r\n               -  Total neutrophil count less than 1,500 cells/mm3\r\n\r\n               -  Serum creatinine greater than or equal to 1.5 x ULN\r\n\r\n               -  Alanine aminotransferase (ALT) greater than 3.0 x ULN\r\n\r\n               -  Aspartate aminotransferase (AST) greater than 3.0 x ULN\r\n\r\n               -  Alkaline phosphatase greater than 2.0 x ULN\r\n\r\n               -  Bilirubin greater than 1.5 x ULN\r\n\r\n               -  Temperature greater than or equal to 38C or any other evidence of an infection\r\n\r\n          6. History of alcohol or substance abuse or dependence during the 12 months prior to\r\n             Screening\r\n\r\n               -  During the study, alcohol consumption of greater than 21 units per week for males\r\n                  and greater than14 units per week for females will not be allowed. One unit of\r\n                  alcohol equals  pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6\r\n                  gill (25 mL) of spirits;\r\n\r\n               -  Positive urine drug screen (confirmed by repeat) or alcohol consumption\r\n                  (self-report) higher than the permissible limit, as mentioned above, within the\r\n                  preceding 3 days at Screening or Baseline shall be excluded from the study;\r\n\r\n          7. Use or intend to use medication that interacts with CYP3A4 and/or CYP2D6.\r\n\r\n          8. Has an allergy or hypersensitivity to the study drug or its components;\r\n\r\n          9. Female patients who are pregnant at Screening or are planning on becoming pregnant, or\r\n             are currently breastfeeding;\r\n\r\n         10. Patients with any medical condition or comorbidities that could adversely impact study\r\n             participation or safety, conduct of the study, or interfere with pain assessments;\r\n\r\n         11. Active skin conditions such as dermatitis, allergy, eczema, psoriasis, or abnormal\r\n             skin healing in any body area;\r\n\r\n         12. Patients who have tattoos, scars, or moles that in the opinion of the Investigator are\r\n             likely to interfere with dosing or study assessments at any of the potential injection\r\n             sites;\r\n\r\n         13. Depression of moderate severity or more on the Patient Health Questionnaire (PHQ-9\r\n             greater than or equal to 10) at the Screening visit;\r\n\r\n         14. History of psychotic symptoms requiring antipsychotic treatment, or history of a\r\n             suicide attempt/s within 180 days prior to Screening;\r\n\r\n         15. Arterial or venous thrombus, myocardial infarction, hospital admission for unstable\r\n             angina, treatment with cardiac angioplasty, or cardiac vessel stenting within 90 days\r\n             prior to Screening;\r\n\r\n         16. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome-related\r\n             illness, acute or history of chronic hepatitis B or C. Positive tests for HIV-1 or -2\r\n             antibodies, hepatitis B surface antigen, or hepatitis C antibodies;\r\n\r\n         17. Current medical or arthritic condition/s that could interfere with evaluation of the\r\n             index joint including fibromyalgia, rheumatoid arthritis, or other inflammatory\r\n             arthropathies;\r\n\r\n         18. Patient who has undergone arthroscopic or open surgery to the index joint/s within 180\r\n             days of Screening visit;\r\n\r\n         19. Patient who has undergone replacement surgery of the index joint/s within 180 days of\r\n             Screening visit;\r\n\r\n         20. The placement of surgical hardware or other foreign body in the treatment joint/s\r\n             within 180 days of Screening visit;\r\n\r\n         21. Use or intend to use any medications/products known to alter the absorption,\r\n             metabolism, or elimination processes of the study drug, including but not limited to\r\n             St. John's Wort, within 30 days prior to Screening visit, unless deemed acceptable by\r\n             the Investigator (or designee);\r\n\r\n         22. Use or intend to use any prescription medications/products within 14 days prior to\r\n             Screening, unless deemed acceptable by the Investigator (or designee). Note: hormone\r\n             replacement therapy or oral, implantable, injectable, or intrauterine contraceptive\r\n             concomitant medications are acceptable;\r\n\r\n         23. Use or intend to use slow-release medications/products considered to still be active\r\n             within 14 days prior to Screening, unless deemed acceptable by the Investigator (or\r\n             designee);\r\n\r\n         24. Use or intend to use any non-prescription medications/products including\r\n             phytotherapeutic/herbal/plant-derived preparations within 14 days prior to Screening\r\n             visit, unless deemed acceptable by the Investigator (or designee) and Sponsor, or\r\n             assignee, has given their prior consent;\r\n\r\n         25. Patients who are unable or unwilling to cease the use of tobacco- or\r\n             nicotine-containing products during the study duration and have used tobacco- or\r\n             nicotine-containing products within 90 days prior to Screening visit;\r\n\r\n         26. Receipt of blood products within 60 days prior to Screening visit;\r\n\r\n         27. Donation of blood from 90 days prior to Screening, plasma from 14 days prior to\r\n             Screening, or platelets from 42 days prior to Screening;\r\n\r\n         28. Poor peripheral venous access;\r\n\r\n         29. Are sponsor employees;\r\n\r\n         30. Have participated in a clinical study involving administration of an investigational\r\n             drug in the past 90 days or 5 half-lives of the study drug, whichever is longer, prior\r\n             to Screening visit;\r\n\r\n         31. Have participated in any trial of a device, supplement, cognitive/behavioural therapy,\r\n             physiotherapy or active exercise study within 30 days prior to the Screening visit;\r\n\r\n         32. Have previously completed or withdrawn from this study or any other study\r\n             investigating OLP-1002 or have previously received the study drug;\r\n\r\n         33. Patients who, in the opinion of the Investigator (or designee), should not participate\r\n             in this study.\r\n      ","sponsor":"OliPass Australia Pty Ltd","sponsor_type":"Industry","conditions":"Osteoarthritis","interventions":[{"intervention_type":"Drug","name":"Drug: A: OLP-1002","description":"10 patients will receive 5 g OLP-1002 twice-weekly (BIW) OLP-1002"},{"intervention_type":"Drug","name":"Drug: B: OLP-1002","description":"10 patients will receive 10 g OLP-1002 BIW OLP-1002"},{"intervention_type":"Drug","name":"Drug: C: Placebo","description":"10 patients will receive Placebo BIW"}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of Treatment- Emergent Adverse Events(Safety and Tolerability) of OLP-1002 in patients who have pain in a hip and/or knee joint","time_frame":"Monitored from Screening Visit till the end of the study visit(day 45).","description":"Number of participants with treatment-related adverse events as assessed by CTCAE"},{"outcome_type":"primary","measure":"Safety and tolerability (Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign- heart rate","time_frame":"Monitored from Screening Visit till the end of the study visit(day 45).","description":"Measured by result of the Vital Sign- heart rate"},{"outcome_type":"primary","measure":"Safety and tolerability (Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign- blood pressure","time_frame":"Monitored from Screening Visit till the end of the study visit(day 45).","description":"Measured by result of the Vital Sign- blood pressure"},{"outcome_type":"primary","measure":"Safety and tolerability (Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign- oral temperature","time_frame":"Monitored from Screening Visit till the end of the study visit(day 45).","description":"Measured by result of the Vital Sign- oral temperature"},{"outcome_type":"primary","measure":"Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through 12-lead ECG","time_frame":"Monitored from Screening Visit till the end of the study visit(day 45).","description":"Measured by result of the ECG measurements and findings Parameters: QRS, ST segment, and QTcF."},{"outcome_type":"primary","measure":"Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Physical exam","time_frame":"Monitored from Screening Visit till the end of the study visit(day 45).","description":"Measured by result of the physical exam which includes general appearance, head, ears, eyes, nose, throat, dentition, thyroid, chest (heart, lungs), abdomen, skin, neurological, extremities, back, neck, musculoskeletal, and lymph nodes."},{"outcome_type":"primary","measure":"Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Clinical laboratory results","time_frame":"Monitored from Screening Visit till the end of the study visit(day 45).","description":"Measured by clinically significant change from baseline clinical laboratory results"},{"outcome_type":"secondary","measure":"To evaluate the preliminary efficacy of OLP-1002 on pain, during the treatment and follow-up periods through WOMAC. The minimum and maximum values, and whether higher scores mean a better or worse outcome.","time_frame":"Monitored on Day 4, 8, 11, 15, 18, 25, 32 and 45.","description":"Measured by Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain, Stiffness and Physical Function Subscales together with Total WOMAC Score"},{"outcome_type":"secondary","measure":"To evaluate the preliminary efficacy of OLP-1002 on pain, during the treatment and follow-up periods through VAS. The minimum and maximum values, and whether higher scores mean a better or worse outcome.","time_frame":"Monitored on Day 4, 8, 11, 15, 18, 25, 32 and 45.","description":"Measured by Visual Analogue Scale (VAS)- Worst daily pain intensity"},{"outcome_type":"secondary","measure":"To characterize the pharmacokinetic (PK) profile of OLP-1002 trough concentration (Ctrough)","time_frame":"PK samples will be collected pre-dose on days Day 1, 8 and 15 as well as on Day 45","description":"Parameter: trough concentration (Ctrough); sample type used for these analysis: serum sample"},{"outcome_type":"secondary","measure":"To monitor the effects of multiple SC doses of OLP-1002 on Quality of Life (QoL) through Score (KOOS). The minimum and maximum values, and whether higher scores mean a better or worse outcome.","time_frame":"Monitored on Day 8, 15, 25, 32 and 45","description":"Measured by Change from Baseline in the Knee Injury and Osteoarthritis Outcome Score (KOOS)"},{"outcome_type":"secondary","measure":"To monitor the effects of multiple SC doses of OLP-1002 on Quality of Life (QoL) through Score (HOOS) QoL Subscale. The minimum and maximum values, and whether higher scores mean a better or worse outcome.","time_frame":"Monitored on Day 8, 15, 25, 32 and 45","description":"Measured by Change from Baseline in Hip Injury and Osteoarthritis Outcome Score (HOOS) QoL Subscale"}]}
{"nct_id":"NCT04301011","start_date":"2020-06-02","phase":"Phase 1/Phase 2","enrollment":114,"brief_title":"Study of TBio-6517, Given Intratumorally, Alone or in Combination With Pembrolizumab, in Solid Tumors","official_title":"A Phase 1/2a, Multicenter, Open-label Trial of TBio-6517, an Oncolytic Vaccinia Virus, Administered by Intratumoral Injection, Alone and in Combination With Pembrolizumab, in Patients With Advanced Solid Tumors","primary_completion_date":"2022-08-20","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-12-30","last_update":"2021-05-07","description":"To determine the recommended Phase 2 dose (RP2D) of TBio-6517 when administered by direct injection into tumor(s) alone and when combined with pembrolizumab in patients with solid tumors (RIVAL-01).","other_id":"TBio-6517-ITu-001","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Key Inclusion Criteria:\r\n\r\n          -  Have a histologically or pathologically documented, locally-advanced or metastatic\r\n             solid tumor for which standard curative measures do not exist or are no longer\r\n             effective\r\n\r\n          -  Measurable disease as per RECIST 1.1 criteria\r\n\r\n          -  At least one tumor amenable to safe ITu injections and biopsies\r\n\r\n          -  ECOG performance status 0 or 1\r\n\r\n          -  Demonstrate adequate organ function\r\n\r\n          -  Must be willing to comply with all protocol procedures and adhere to post-treatment\r\n             care instructions\r\n\r\n          -  Additional Inclusion criteria exist\r\n\r\n        For patients in phase 2 only: Have a histologically or cytologically confirmed advanced\r\n        (metastatic and/or unresectable) solid tumor listed below, that is incurable and for which\r\n        prior standard treatment has failed:\r\n\r\n          1. MSS-CRC patients that have progressed to at least 2 prior lines of systemic therapy\r\n             which should include irinotecan and oxaliplatin with or without bevacizumab, or,\r\n\r\n          2. TNBC patients who have failed anthracycline- and taxane-based chemotherapy. TNBC\r\n             patients with PD-L1 positive tumors must also have failed treatment with PD-1 or PD-L1\r\n             targeted therapy.\r\n\r\n        Key Exclusion Criteria:\r\n\r\n          -  Prior systemic therapy, including experimental, surgery or radiation therapy within 4\r\n             weeks and must have recovered from acute toxicity.\r\n\r\n          -  Prior treatment with any oncolytic virus.\r\n\r\n          -  Requires use of anti-platelet or anti-coagulant therapy that cannot be safely\r\n             suspended for per protocol biopsies or intra-tumoral injections.\r\n\r\n          -  CNS metastases and/or carcinomatous meningitis that have not been completely resected\r\n             or completely irradiated.\r\n\r\n          -  Prior history of myocarditis\r\n\r\n          -  Symptomatic or asymptomatic cardiovascular disease\r\n\r\n          -  Known HIV/AIDS, active HBV or HCV infection.\r\n\r\n          -  Received immunosuppressive medication within 4 weeks. (>10mg/day prednisone)\r\n\r\n          -  Known intolerance to anti-PD-1 or anti-PD-L1 antibody therapy\r\n\r\n          -  Additional Exclusion criteria exist\r\n      ","sponsor":"Turnstone Biologics, Corp.","sponsor_type":"Industry","conditions":"Solid Tumor|Triple Negative Breast Cancer|Microsatellite Stable Colorectal Cancer","interventions":[{"intervention_type":"Biological","name":"Biological: TBio-6517","description":"Engineered Oncolytic Vaccinia Virus"},{"intervention_type":"Biological","name":"Biological: Pembrolizumab","description":"Immune checkpoint inhibitor."}],"outcomes":[{"outcome_type":"secondary","measure":"Median Duration of Response (DoR)","time_frame":"25 months","description":"Median duration of response in patients with a CR or PR"},{"outcome_type":"secondary","measure":"Time to tumor progression (TTP)","time_frame":"25 months","description":"Median time until patient disease progression (PD)"},{"outcome_type":"secondary","measure":"Median progression free survival","time_frame":"25 months","description":"Median duration of progression free survival of patients"},{"outcome_type":"secondary","measure":"Median Disease Control Rate (DCR)","time_frame":"25 months","description":"Median duration of response in patients with a CR, PR, or stable disease (SD)"},{"outcome_type":"secondary","measure":"Proportion of patients with a response (ORR)","time_frame":"25 months","description":"Percentage of patients in all arms with a CR or PR as assessed by the central radiologist using RECIST 1.1 and iRECIST"},{"outcome_type":"primary","measure":"Incidence of adverse events when TBio-6517 administered by direct injection into tumor(s) alone at each dose level","time_frame":"25 months","description":"Percentage of patients with adverse events by grade as determined by NCI CTCAE v5.0"},{"outcome_type":"primary","measure":"Incidence of adverse events when TBio-6517 administered by direct injection into tumor(s) when combined with pembrolizumab","time_frame":"25 months","description":"Percentage of patients with adverse events by severity as determined by NCI CTCAE v5.0"},{"outcome_type":"primary","measure":"Maximum tolerated dose (MTD) or Maximum feasible dose (MFD) and determination of the recommended Phase 2 dose (RP2D) of TBio-6517 alone and in combination with pembrolizumab.","time_frame":"4 weeks","description":"The highest dose of TBio-6517 that can be administered where fewer than 2 patients have a dose-limiting safety event alone or when combined with pembrolizumab as assessed by NCI CTCAE v.5.0 during the Phase 1 dose escalation"},{"outcome_type":"primary","measure":"Percentage of overall response rate (ORR) by RECIST 1.1 at the RP2D","time_frame":"25 months","description":"Percentage of patients treated at the RP2D in combination with pembrolizumab with a partial response or complete response by RECIST 1.1 following central radiologist review"},{"outcome_type":"primary","measure":"Percentage of overall response rate (ORR) by immunotherapy RECIST (iRECIST) at the RP2D","time_frame":"25 months","description":"Percentage of patients treated at the RP2D with pembrolizumab with a partial response (PR) or complete response (CR) by iRECIST following central radiologist review"},{"outcome_type":"secondary","measure":"Number and severity of adverse events at the RP2D","time_frame":"25 months","description":"Number of patients with adverse events by severity and frequency as determined by NCI CTCAE v5.0"},{"outcome_type":"secondary","measure":"Median overall survival (OS)","time_frame":"48 months","description":"Median overall survival in months in patients"}]}
{"nct_id":"NCT04061304","start_date":"2020-06-01","phase":"Phase 2","enrollment":0,"brief_title":"A Clinical Trial Into the Efficacy of rTMS Treatment for Treating Anorexia Nervosa and Bulimia Nervosa","official_title":"A Clinical Trial Into the Efficacy of rTMS Treatment for Treating Anorexia Nervosa and Bulimia Nervosa","primary_completion_date":"2021-03-19","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2021-03-19","last_update":"2021-03-25","description":"This is a pilot study to test the efficacy of repetitive transcranial magnetic stimulation (rTMS) in treating individuals with Anorexia Nervosa and Bulimia Nervosa. The main objective of this study is to determine the short and long-term efficacy of repetitive transcranial magnetic stimulation (rTMS) in reducing eating disorder symptoms (i.e. binging, purging, restricting, intense fear of gaining wait, etc;) in Anorexia Nervosa and Bulimia Nervosa. The investigators will also be comparing the brain activity patterns of individuals with Anorexia Nervosa and Bulimia Nervosa to healthy controls using electroencephalography (EEG). Further, the investigators would like to examine if the activation patterns in these patients change after receiving rTMS.","other_id":"HS22828 (B2019:033)","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Confirmed diagnosis of Anorexia Nervosa or Bulimia Nervosa, must pass rTMS screening\r\n             questionnaire\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Diagnosis of another psychiatric disorder, except MDD.\r\n\r\n          -  Any rTMS counter-indications:\r\n\r\n          -  History of seizures\r\n\r\n          -  Metal in head\r\n\r\n          -  Currently pregnant\r\n\r\n          -  Having received rTMS for any reason in the past as this would interfere with\r\n             participant blinding.\r\n      ","sponsor":"University of Manitoba","sponsor_type":"Other","conditions":"Eating Disorders|Anorexia Nervosa|Bulimia Nervosa","interventions":[{"intervention_type":"Device","name":"Device: Repetitive Transcranial Magnetic Stimulation","description":"A non-invasive method of brain stimulation."},{"intervention_type":"Device","name":"Device: Sham Transcranial Magnetic Stimulation","description":"A device designed to look, sound, and feel like a real magnetic stimulation coil without actually stimulating the brain."}],"outcomes":[{"outcome_type":"primary","measure":"Weekly Binge/Purge Frequency on Eating Disorder Examination","time_frame":"baseline, after week 1, week 2, and week 3 of treatment, 3 months post treatment, and 6 months post treatment.","description":"Outcome measured by change of binge/purge episodes from baseline to the end of treatment. If the participant has a final score of 0 binges and 0 purges they will be considered in remission. A 50% improvement will be defined as a response to the rTMS."},{"outcome_type":"secondary","measure":"Change in Beck Anxiety Inventory (BAI)","time_frame":"baseline, after week 1, week 2, and week 3 of treatment, 3 months post treatment, and 6 months post treatment.","description":"Outcome range: 0-63, with higher scores reflecting higher levels of anxiety. A total of 21 questions are summed for a total score out of 63."},{"outcome_type":"secondary","measure":"Change in Beck Depression Inventory (BDI)","time_frame":"baseline, after week 1, week 2, and week 3 of treatment, 3 months post treatment, and 6 months post treatment.","description":"Outcome range: 0-63, with higher scores reflecting higher levels of depression. A total of 21 questions are summed for a total score out of 63."}]}
{"nct_id":"NCT04193878","start_date":"2020-06-01","phase":"Phase 3","enrollment":600,"brief_title":"ARrest RESpiraTory Failure From PNEUMONIA","official_title":"ARrest RESpiraTory Failure From PNEUMONIA (ARREST PNEUMONIA)","primary_completion_date":"2024-04-01","study_type":"Interventional","rec_status":"Enrolling by invitation","completion_date":"2024-06-01","last_update":"2021-03-19","description":"This research study seeks to establish the effectiveness of a combination of an inhaled corticosteroid and a beta agonist compared to placebo for the prevention of acute respiratory failure (ARF) in hospitalized patients with pneumonia and hypoxemia.","other_id":"53599","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Severe Pneumonia defined as hospitalization for acute (< 7 days) onset of symptoms\r\n             (cough, sputum production, or dyspnea) and radiographic evidence of pneumonia by chest\r\n             radiograph or CT scan and evidence of systemic inflammation (temperature < 35oC or >\r\n             38oC or WBC > or < upper or lower limits for site or procalcitonin > 0.5 mcg/L), or\r\n             known current immunosuppression preventing inflammatory response.\r\n\r\n        and\r\n\r\n          -  Hypoxemia defined as new requirement for supplemental oxygen with SpO2 < 90% on room\r\n             air,  96% on  2 L/min oxygen, or > 6L/min or NIV (regardless of SpO2) at enrollment.\r\n\r\n        and\r\n\r\n          -  No clinical suspicion for COVID-19 pneumonia or confirmed negative test for SARS CoV2\r\n             infection.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Inability to obtain consent within 24 hours of presentation to emergency room\r\n\r\n          -  Intubation (or impending intubation) prior to enrollment (This does not include those\r\n             patients receiving High flow nasal cannula (HFNC) oxygen or Noninvasive ventilation\r\n             (NIV) prior to enrollment)\r\n\r\n          -  A condition requiring inhaled corticosteroids or beta-agonists, or chronic systemic\r\n             steroid therapy equivalent to a dose >10 mg prednisone (this does not include patients\r\n             receiving inhaled beta-agonists in the Emergency Department without an established\r\n             indication if treating clinician is willing to discontinue subsequent treatments)\r\n\r\n          -  Chronic lung or neuromuscular disease requiring daytime oxygen or mechanical\r\n             ventilation other than for obstructive sleep apnea (OSA) or obesity hypoventilation\r\n             syndrome\r\n\r\n          -  Not anticipated to survive > 48 hours or not expected to require > 48 hours of\r\n             hospitalization\r\n\r\n          -  Contraindication or known allergy to inhaled corticosteroids or beta-agonists\r\n\r\n          -  Patients with heart rate > 130 bpm, ventricular tachycardia or new supraventricular\r\n             tachycardia within last 4 hours will be potentially eligible for enrollment after the\r\n             condition has resolved\r\n\r\n          -  Patients with K+ < 3.0 will be potentially eligible for enrollment after the condition\r\n             has resolved\r\n\r\n          -  Patient not committed to full support other than intubation or resuscitation (i.e.,\r\n             DNR/DNI status allowed)\r\n\r\n          -  Pregnancy\r\n\r\n          -  Incarcerated individual\r\n\r\n          -  Physician refusal of consent to protocol\r\n\r\n          -  Patient/surrogate refusal of consent to protocol\r\n      ","sponsor":"Stanford University","sponsor_type":"Other","conditions":"Pneumonia|Hypoxemia|Acute Respiratory Failure","interventions":[{"intervention_type":"Drug","name":"Drug: Inhaled budesonide and formoterol","description":"aerosolized doses of budesonide (1.0 mg/2 ml) and formoterol (20 mg/2 ml) twice daily for up to 5 days"},{"intervention_type":"Drug","name":"Drug: Inhaled placebo","description":"aerosolized saline (4 ml of 0.9% saline) twice daily for up to 5 days"}],"outcomes":[{"outcome_type":"primary","measure":"Acute respiratory failure (ARF)","time_frame":"within 7 days of randomization","description":"High flow nasal cannula (HFNC) and/or Noninvasive ventilation (NIV) use for greater than 36 hours OR Invasive mechanical ventilation for greater than 36 hours OR Death in a patient placed on respiratory support (HFNC, NIV, ventilator) who dies before 36 hours"},{"outcome_type":"secondary","measure":"Hospital length of stay","time_frame":"within 60 days of randomization"},{"outcome_type":"secondary","measure":"Duration of need for supplemental oxygen","time_frame":"within 60 days of randomization"},{"outcome_type":"secondary","measure":"Proportion of patients intubated for respiratory failure","time_frame":"Within 7 days of randomization"}]}
{"nct_id":"NCT04387266","start_date":"2020-06-01","enrollment":471,"brief_title":"To Evaluate the Efficacy and Feasibility of Modified Reduce-volume Target IMRT in the Treatment of Patients With Non-metastatic NPC","official_title":"A Retrospective Real-world Study in Patients With Nasopharyngeal Carcinoma: to Evaluate the Efficacy and Feasibility of Modified Reduce-volume Target IMRT in the Treatment of Patients With Non-metastatic NPC","primary_completion_date":"2020-08-01","study_type":"Observational","rec_status":"Completed","completion_date":"2020-10-01","last_update":"2020-10-09","description":"This is a retrospective real-world study to evaluate the efficacy and feasibility of modified reduce-volume target IMRT in the treatment of patients with non-metastatic NPC","other_id":"NPC004","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Probability Sample","gender":"All","population":"Non-metastatic NPC patients treated with modified reduce-volume target IMRT in our\r\n        institution","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Pathologic diagnosis (pathologically confirmed by nasopharyngeal biopsy) was\r\n             nasopharyngeal carcinoma;\r\n\r\n          2. Newly diagnosed, non-metastatic and treated with modified reduce-volume IMRT;\r\n\r\n          3. Patients with baseline MRI date of nasopharynx and neck, and completed the first\r\n             course of treatment in our hospital;\r\n\r\n          4. Diagnosis time: November 1, 2014 to December 31 , 2017\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Disease progression during IMRT;\r\n\r\n          2. Previous malignancy or other concomitant malignant diseases;\r\n\r\n          3. The evaluation information of tumor efficacy can not be obtained;\r\n\r\n          4. Receive blind treatment in other clinical research.\r\n      ","sponsor":"Fujian Cancer Hospital","sponsor_type":"Other","conditions":"Nasopharyngeal Carcinoma","interventions":[{"intervention_type":"Radiation","name":"Radiation: modified reduce-volume target IMRT","description":"The gross tumor volume of the nasopharynx and neck nodes (GTVnx and GTVnd) were delineated according to the tumor extension. The CTVnx was defined as GTVnx + nasopharynx mucosa + 8mm +corresponding anatomical structure without the delineation of CTV1. The CTVnd was defined as GTVnd plus the elective neck area. The prescribe doses of GTVnx/GTVnd, CTVnx, CTVnd were 66-70Gy,54-56Gy and 50-54Gy in 31-35 fractions, respectively."}],"outcomes":[{"outcome_type":"primary","measure":"Local failure-free survival (LFFS)","time_frame":"60 month","description":"The duration of time to LFFS was calculated from the date of histological diagnosis until documented treatment local failure."}]}
{"nct_id":"NCT04435067","start_date":"2020-05-27","enrollment":44,"brief_title":"Evaluation of Clinical, Radiomics and Molecular Features of Lung Metastasis in PDAC Patients (LUMACA Trial)","official_title":"Retrospective Observational Study on Patients With Lung Metastases From Pancreatic Adenocarcinoma: Evaluation of Clinical Features and Correlation With Molecular and Radiomics Features","primary_completion_date":"2021-12-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2021-12-31","last_update":"2020-07-16","description":"The aim of this study is the characterization from epidemiological, radiomics and molecular point of view of lung metastasis of patients at beginning affected by pancreatic adenocarcinoma (PDAC), which after the resection of primitive tumor have met with initial recurrence of the disease exclusively at the lung level.","other_id":"PACT32","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"All patients with a confirmed diagnosis of lung metastasis from PDAC from 2008 to 2019","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Cytological/histological diagnosis of pancreatic adenocarcinoma as a primary tumor and\r\n             localization of adenocarcinoma compatible with pancreatic primitivity for lung\r\n             metastasis;\r\n\r\n          -  Previous surgical resection of the primary tumor;\r\n\r\n          -  Exclusive presence of single or multiple lung metastasis at disease recurrence;\r\n\r\n          -  Radical or diagnostic excision of lung metastasis;\r\n\r\n          -  Informed patient consent (for currently living patients).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients not undergoing lung resection surgery for diagnostic and/or therapeutic\r\n             purposes for cardiac or respiratory functional contraindication.\r\n\r\n          -  Patients with lung metastases synchronous with primary cancer. Contacts and Locations\r\n      ","sponsor":"IRCCS San Raffaele","sponsor_type":"Other","conditions":"Pancreas Adenocarcinoma","interventions":[{"intervention_type":"Genetic","name":"Genetic: Analysis of genetic mutations and the gene expression profile of lung metastasis and primary neoplasia","description":"The mutational analysis of the main oncogenes and tumor suppressor genes involved in the genesis and tumor progression will be performed on the genomic DNA extracted from each sample using the Ion Torrent TM Oncomine TM Comprehensive Assay version 3 (OCAv3) kit. This panel includes 161 cancer-related genes and allows the identification of all genomic alterations affecting oncogenes and recurrently altered tumor suppressor genes in solid tumors. The study of gene expression will be carried out using Nanostring Technology using the Pancancer IO 360 TM panel which allows simultaneous analysis for each sample of multiple mRNAs associated with crucial pathways in carcinogenesis and the immunological profile of the tumor, defining its up and down conditions gene regulation."},{"intervention_type":"Other","name":"Other: Radiomics analysis on TAC imaging at diagnosis of lung metastasis and, if possible, of the primary tumor","description":"This study will be performed using the SPAARC IBSI (International Biomarker Standardization Initiative) compliant software implemented in the MatLab environment (MathWorks, Boston, USA) through several steps: (a) CT imaging retrieval, (b) image segmentation and rendering, (c) feature extraction and (d) qualification/quantification. Approximately 200 radiomics characteristics will be extracted, such as: Morphology, Statistical, Intensity Histogram, Gray Level Co-occurrence Matrix 3D_average, Gray Level Co-occurrence Matrix 3D_combined, Gray Level Run Length 3D_average, Gray Level Run Length 3D_combined, Gray Level Size Zone Matrix 3D, Neighbor Gray Tone Difference Matrix 3D, Gray Level Distance Zone Matrix 3D."}],"outcomes":[{"outcome_type":"primary","measure":"Clinical and pathological features of lung metastasis","time_frame":"6 months","description":"Analyze the clinical and pathological characteristics of the two cohorts of patients affected by lung metastasis from PDAC"},{"outcome_type":"secondary","measure":"Molecular and radiomics features of lung metastasis","time_frame":"18 months","description":"Correlate the pathological characteristics of the two cohorts of patients affected by lung metastasis from PDAC with radiomics and molecular features, in order to identify prognostic and/or predictive factors related to lung metastasis in the PDAC"},{"outcome_type":"secondary","measure":"Differences between the two cohorts","time_frame":"18 months","description":"Highlight any differences between the two cohorts of patients examined"}]}
{"nct_id":"NCT04404270","start_date":"2020-05-26","enrollment":1146,"brief_title":"Study of SARS-CoV2 Virus (COVID-19) Seroprevalence in the Population of Creil Air Force Base (BA110)","official_title":"Study of SARS-CoV2 Virus (COVID-19) Seroprevalence in the Population of Creil Air Force Base (BA110)","primary_completion_date":"2021-03-13","study_type":"Observational","rec_status":"Completed","completion_date":"2021-03-13","last_update":"2021-07-07","description":"In mid-February 2020, within the Oise (France) cluster, a case of COVID-19 disease caused by a SARS-CoV2 infection was described among the personnel of the Creail Air Force Base (BA110). This resulted in the beginning of an epidemic controlled by epidemiological measures. One month later, containment measures were taken at the national level, measures that also applied to BA110 personnel. These personnel, exposed to both the initial phase of the epidemic and national protection measures, represent an extremely interesting population for understanding the epidemiological dynamics of the virus, particularly at a time when France is lifting the containment measures. It becomes extremely important to understand the levers of viral spread in order to adjust the health measures to be maintained as best as possible. The main objective of this study is to determine the extent of virus diffusion in this highly circulating population, as evidenced by several identified cases of COVID-19.","other_id":"2020-COVID19-22","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"The eligible population is composed of all civilian and military personnel working on the\r\n        Creil Air Force Base (BA110) or having worked on BA110 as a permanent personnel since\r\n        February 1st 2020, including the people working in satellite units such as the \"Groupement\r\n        de soutien de base de Dfense\" de Creil (\"Creil Defence Base Support Group\") or the 3/60\r\n        Esterel squadron.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Active military or civilian defence personnel working on the Creil Air Force Base\r\n             (BA110) during the period of interest (from February 1st 2020 to the end of the study)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Contraindication to blood sampling\r\n\r\n          -  Pregnant, parturient, breastfeeding woman\r\n      ","sponsor":"Direction Centrale du Service de Sant des Armes","sponsor_type":"Other","conditions":"Sars-CoV2","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Anti-SARS-CoV2 Serology","description":"The anti-SARS-CoV2 serological status will be measured on a blood sample collected at Day 0."},{"intervention_type":"Behavioral","name":"Behavioral: Questionnaire","description":"Epidemiological data will be collected in a questionnaire that will be filled by participants at Day 0 (Visit 1), after 3 months (Visit 2) and after 9 months (Visit 3).\r\nThe questionnaire includes:\r\nmedical data (height, weight, smoking, history of intense stress);\r\nsocio-demographic data (age, gender, civil/military status, function/occupation, rank category, army, family status/home composition, housing conditions, etc.);\r\nclinical data : history of symptoms suggestive of COVID-19 in the last 3 months, current symptoms suggestive of COVID-19;\r\nuse of care, hospitalization, work stoppage in the last 3 months;\r\ncontact with people who are symptomatic or proven COVID-19."},{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Anti-SARS-CoV2 serological controls and serum neutralization","description":"Serological controls and a serum neutralization test will be performed on blood samples collected 3 months (Visit 2) and 9 months (Visit 3) after Day 0, respectively."}],"outcomes":[{"outcome_type":"secondary","measure":"Proportion of serum neutralization positive","time_frame":"Day 0","description":"Among anti-SARS-CoV2 seropositive participants, the percentage of participants with a positive response to serum neutralization will be determined."},{"outcome_type":"secondary","measure":"Change of antibody level over time","time_frame":"3 months and 9 months after Day 0","description":"The evolution of the antibody level over time will be determined using repeated serodiagnoses at 3 and 9 months."},{"outcome_type":"primary","measure":"Proportion anti-SARS-CoV2 seropositive","time_frame":"Day 0","description":"The percentage of the study population with positive serological status will be determined. ELISA serology test will be used to detect anti-SARS-CoV2 antibodies (IgG and IgM) at Day 0"},{"outcome_type":"secondary","measure":"Proportion of asymptomatic anti-SARS-CoV2 seropositive participants","time_frame":"Day 0","description":"Among anti-SARS-CoV2 seropositive participants, the percentage of asymptomatic participants will be determined. COVID-19 symptoms will be measured using a questionnaire."},{"outcome_type":"secondary","measure":"Agreement between the anti-SARS-CoV2 serological results obtained using two different techniques (detecting the presence of different antibodies)","time_frame":"Day 0","description":"The serological results obtained using the reference ELISA test results (detecting the presence of IgG and IgM antobodies) and using a second ELISA test detecting the presence of antibodies specifically directed against the Receptor Binding Domain and the Spike protein trimer of SARS-CoV2 virus will be compared."}]}
{"nct_id":"NCT04407793","start_date":"2020-05-25","enrollment":500,"brief_title":"Prospective and Multicentre Study on Clinical-biological Factors Predictive of Chronic Colon DIverticulitis","official_title":"Prospective and Multicentre Study on Clinical-biological Factors Predictive of Chronic Colon DIverticulitis","primary_completion_date":"2021-05-25","study_type":"Observational [Patient Registry]","rec_status":"Recruiting","completion_date":"2023-05-25","last_update":"2020-06-09","description":"MAIN OBJECTIVE: Description of predicted markers of acute diverticulitis crisis, using bivariate and multivariate analyses. Analysis of acute diverticulitis predictor swings. SIDE OBJECTIVES: Descriptive analysis of HRQL in the different measurement periods to establish the evolution of the disease. Correlate HRQL values of systemic and local inflammatory markers in the diverticulitis group. Sub-analysis of patients with immunosuppression to evaluate disease virulence compared to a group of patients without immunosuppression. STUDY TYPE: Clinical, observational, prospective and multicenter study (8 hospitals) with three study groups: patients diagnosed with acute diverticulitis attending emergencies, diverticulosis patients and patients without diverticulums. INCLUSION CRITERIA: Age > 18years and radiological diagnosis by abdominal CT acute diverticulitis. EXCLUSION CRITERIA: Rejection of the patient -severe diverticulitis requiring urgent surgery -an inability to understand HRQL questionnaire - IBD - pregnancy or breastfeeding - acute diverticulitis within the prior year of the study - Roma IV criteria fulfilment. VARIABLES: Main variables: local and systemic inflammatory markers- faecal calprotectin. Secondary variables: recurrence of acute diverticulitis -the persistence of symptoms - SF 12 and GIQLI questionnaires. STATISTICS: Sample size: alpha error 0.05; beta error 0.20; bilateral; proportion 0.9 in the control group; 500 subjects group diverticulitis, 200 group diverticulosis and not diverticulums.","other_id":"DICRO-2020","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"DIVERTICULITIS COHORT: Patients with current acute diverticulitis, diagnosed with abdominal\r\n        CT and not requiring urgent surgery for this reason","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age > 18years\r\n\r\n          -  Current episode of acute diverticulitis diagnosed with abdominal CT\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Rejection of the patient\r\n\r\n          -  Severe diverticulitis requiring urgent surgery\r\n\r\n          -  Inability to understand HRQL questionnaires\r\n\r\n          -  IBD background\r\n\r\n          -  Pregnancy or lactation\r\n\r\n          -  Acute diverticulitis episodes within the prior year to the start of the study\r\n\r\n          -  Patients who meet Roma IV criteria for IBS\r\n      ","sponsor":"Sebastiano Biondo","sponsor_type":"Other","conditions":"Acute Diverticulitis","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Recurrence of acute diverticulitis","time_frame":"2 years","description":"To detect which patients with acute diverticulitis recur"},{"outcome_type":"primary","measure":"Systemic inflammatory markers","time_frame":"2 years","description":"To correlate systemic inflammatory markers with acute diverticulitis recurrence.\r\n* Systemic inflammatory markers include: A blood test with leukocyte count and formula, C-reactive protein, albumin, Neutrophil-Lymphocyte ratio calculation, Platelet-lymphocyte ratio calculation, lymphocyte-monocyte ratio calculatio, Modified Glasgow Prognostic score calculation."},{"outcome_type":"primary","measure":"Faecal calprotectine","time_frame":"2 years","description":"To correlate faecal calprotectine with acute diverticulitis recurrence"},{"outcome_type":"primary","measure":"Local inflammatory markers","time_frame":"2 years","description":"To correlate local inflammatory markers with systemic inflammatory markers and recurrence.\r\n*Local inflammatory markers come from colonic endoscopic samples taken in the colonoscopy at 2 months after the acute diverticulitis episode. 2 samples are taken:\r\nSample A: 1-5cm of diverticulum that has participated in diverticulitis episode (correlated with the CT)\r\nSample B: 30cm of the area that has suffered diverticulitis. Sampling for the study of local inflammatory markers includes IL-6, IL-10, tumour necrosis factor (TNF), macrophages, eosinophils and calculation of inflammation index of Ulcerative Colitis."},{"outcome_type":"secondary","measure":"HRQL (Health Related Quality of Life) QUESTIONNAIRES","time_frame":"2 years","description":"To correlate clinical symptoms with inflammatory markers.\r\nQuestionnaires used:\r\nSF-12 Health Survey, in order to measure Mental and Physical Health. There are 8 areas with a minimum value of 0 (the worst health state) and a maximum of 100 (best health state)\r\nGIQLI (Gastrointestinal Quality of Life questionnaire). Minimum value of 0 (the worst health state) and a maximum of 100 (best health state)"}]}
{"nct_id":"NCT04401202","start_date":"2020-05-21","phase":"Phase 2","enrollment":183,"brief_title":"Nigella Sativa in COVID-19","official_title":"Effects of Nigella Sativa as a Treatment of Patients With Upper Respiratory Tract Infection Caused by SARS-coronavirus-2: a Prospective, Randomized, Open-label, Controlled Clinical Study","primary_completion_date":"2020-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-12-31","last_update":"2021-05-26","description":"Natural products with immunomodulation and antiviral activity showed a promising improvement in the outcomes of some viral infectious diseases both in preclinical and primitive clinical studies. The aim of this study is to utilize Saudi FDA licensed Nigella sativa (NS) seed oil towards improving disease outcomes in adult patients diagnosed with mild COVID-19. The study will be a prospective, open-label, non-randomized controlled pilot trial. Patients will be supplemented (add-on) with one capsule of black seed oil twice daily for 10 days. The primary outcome will be the proportion of patients who clinically recovered on day 14. The secondary outcomes will be clinical parameters and routine laboratory tests. If encouraging outcomes occurred, NS supplementation may be recommended as an add-on to standard care protocol to enhance the recovery from COVID-19 disease in the current emerging situation.","other_id":"266-20","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Prospective, randomized, open-label, controlled clinical study","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with mild COVID19 upper respiratory tract infection and with no evidence of\r\n             pneumonia\r\n\r\n          -  Adult (18 Years and above)\r\n\r\n          -  Written informed consent prior to initiation of any study procedures by the patient\r\n             (or legally authorized representative).\r\n\r\n          -  Understands and agrees to comply with planned study procedures.\r\n\r\n          -  Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by\r\n             polymerase chain reaction (PCR) available at KAUH.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with pneumonia or severe illness requiring admission to ICU.\r\n\r\n          -  Severe chronic kidney disease (i.e. estimated glomerular filtration rate (eGFR) < 30)\r\n             or end stage renal disease requiring dialysis\r\n\r\n          -  Sever chronic liver disease (Alanine transaminase/aspartate transaminase (ALT/AST) > 5\r\n             times the upper limit of normal).\r\n\r\n          -  Pregnancy or breast feeding.\r\n\r\n          -  Anticipated transfer to another hospital which is not a study site within 72 hours.\r\n\r\n          -  Allergy to any study medication.\r\n      ","sponsor":"King Abdulaziz University","sponsor_type":"Other","conditions":"COVID-19|SARS-CoV-2","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Nigella sativa oil","description":"Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days"}],"outcomes":[{"outcome_type":"secondary","measure":"Side Effects","time_frame":"Day 14","description":"Side effects from the investigational treatment"},{"outcome_type":"primary","measure":"Percentage of Participants With Clinical Recovery Within 14 Days After Randomization","time_frame":"Day 14","description":"The Percentage of patients who had clinical recovery within 14 days after randomization (clinical recovery was defined as three days of no symptoms)"},{"outcome_type":"secondary","measure":"The Number of Days to Recovery","time_frame":"Day 14","description":"The number of days to recovery (number of symptomatic days)"},{"outcome_type":"secondary","measure":"Duration of Each Symptom","time_frame":"Day 14","description":"Duration of each symptom in days"},{"outcome_type":"secondary","measure":"Hospital Admission Due to Disease Complications","time_frame":"Day 14","description":"High severity of COVID-19 (mild cases does not require hospitalization)"}]}
{"nct_id":"NCT04397328","start_date":"2020-05-19","phase":"Phase 3","enrollment":336,"brief_title":"COVID-19 PEP- High-risk Individuals in Long-term and Specialized Care - Canada","official_title":"Safety and Efficacy of Post-exposure Prophylaxis With Hydroxychloroquine (HCQ) for the Prevention of COVID-19 in High-risk Older Individuals in Long-term and Specialized Care: A Double-blind Randomized Control Trial","primary_completion_date":"2021-04-30","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2021-04-30","last_update":"2020-05-21","description":"Older adults are at the highest risk of complications and severe illness for 2019-nCoV infections. Hydroxychloroquine (HCQ), an emerging chemoprophylaxis, which holds clinical and mechanistic plausibility, will help to reduce disease incidence and mitigate disease severity across in-patient settings. This study is designed to assess the safety and efficacy of post-exposure prophylaxis with hydroxychloroquine (HCQ) for the prevention of Coronavirus Infectious Disease-19 (COVID-19) in high-risk older individuals in long-term and specialized care.","other_id":"9881","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age over 40 with two or more high-risk comorbidities that have been found to confer a\r\n             higher risk of mortality including but not limited to :\r\n\r\n             chronic lung disease to include: Chronic obstructive lung disease, interstitial lung\r\n             disease or diffuse parenchymal disease moderate to severe asthma\r\n\r\n               -  Cardiac conditions to include: recent myocardial infarction (within the last\r\n                  three months) or poorly controlled heart failure\r\n\r\n               -  severe obesity (body mass index [BMI] of 40 or higher)\r\n\r\n               -  Diabetes (type 1 or 2)\r\n\r\n               -  chronic kidney disease undergoing dialysis\r\n\r\n               -  liver cirrhosis\r\n\r\n             OR Age over 60.\r\n\r\n          2. Patient/resident in an Institute (to include a rehabilitation, long term care\r\n             facility, mental health facility or veteran's care) that provides bed-based care in\r\n             shared semi-private or ward rooms (i.e. two or more to a room) with a patient with\r\n             confirmed COVID-19 for at least 6 hours in the absence of contact and droplet\r\n             precautions.\r\n\r\n          3. Exposure with a documented or suspected COVID-19 case or from a symptomatic ( defined\r\n             as common symptoms of COVID-19 including but not limited to fever, lethargy, dry\r\n             cough, shortness of breath) health care worker providing direct patient contact within\r\n             3 feet without a mask for > 15min or any physical contact with the staff. Exposure may\r\n             occur in single or shared bedrooms. Exposure may occur in a common dining or activity\r\n             or sitting area. Any patient sharing a room or within 3 feet for > 15min or any\r\n             physical contact without a mask will be considered as a contact. Patients or staff are\r\n             considered as infectious for 48hrs before any symptoms onset and until masked or\r\n             cleared by 2 negative swabs.\r\n\r\n          4. No prior treatment with acetaminophen or NSAIDs or willing to stop present\r\n             prescription of regular or PRN acetaminophen.\r\n\r\n          5. Informed consent (in person or by telephone/e-mail with SDM)\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Greater than 96 hours since last exposure\r\n\r\n          2. Presence of fever (T>37.8), new onset cough, or shortness of breath at enrollment\r\n\r\n          3. A baseline O2 saturation less than 90% (as measured by pulse oximetry) on room air\r\n\r\n          4. Screening ECG QTc interval greater than 500ms by either a 12 lead or 6 lead ECG.\r\n\r\n          5. Concomitant drug-drug interactions (Artemether, Dapsone, Lumefantrine or Mefloquine\r\n             amiodarone, digoxin, dofetilide, flecainide, procainamide, sotalol, or propafenone\r\n             levofloxacin, ciprofloxacin, moxifloxacin, azithromycin, clarithromycin, erythromycin,\r\n             ketoconazole, or itraconazole methadone sumatriptan, or zolmitriptan systemic\r\n             chemotherapy.)\r\n\r\n          6. Already on active palliative care measures (Palliative performance score (PPS) less\r\n             than 30%)\r\n\r\n          7. Hypersensitivity reaction to chloroquine, hydroxychloroquine or aminoquinolines\r\n\r\n          8. History of retinal disease due to previous use of 4-aminoquinoline\r\n\r\n          9. Prior documented and known at enrollment, retinal eye disease or maculopathy including\r\n             but not limited to diabetic retinopathy, retinal detachment, retinitis pigmentosa or\r\n             macular degeneration\r\n\r\n         10. Known glucose-6 phosphate dehydrogenase (G6PD) deficiency\r\n\r\n         11. Known Porphyria\r\n\r\n         12. Acute delirium\r\n\r\n         13. Inability to swallow oral study drug/placebo (even after crushed in the same manner as\r\n             regular prescribed medications)\r\n\r\n         14. Diagnosis of immunodeficiency (e.g. HIV, transplantation) or receiving systemic\r\n             steroid therapy (>10mg prednisone daily or equivalent) or any other form of\r\n             immunosuppressive therapy prior to trial treatment\r\n\r\n         15. Women who are pregnant or breastfeeding\r\n      ","sponsor":"Lawson Health Research Institute","sponsor_type":"Other","conditions":"COVID-19","interventions":[{"intervention_type":"Drug","name":"Drug: Hydroxychloroquine","description":"Hydroxychloroquine vs placebo (1:1 design) double blind intervention"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Hydroxychloroquine vs placebo (1:1 design) double blind intervention"}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of symptomatic fever >37.8, dry cough, or shortness of breath (resident/patient report or nurse observation) respiratory infection with confirmed PCR+ result for SARS-CoV-2.","time_frame":"baseline through day 90"},{"outcome_type":"secondary","measure":"Requirement for admission to acute care hospital and/or ICU admission or death","time_frame":"baseline through day 90"},{"outcome_type":"secondary","measure":"Asymptomatic PCR+ SARS-CoV-2 test result","time_frame":"baseline, days 2, 5, 12, and 19"},{"outcome_type":"secondary","measure":"Time to clinical recovery (TTCR).","time_frame":"baseline through day 90"}]}
{"nct_id":"NCT04381481","start_date":"2020-05-14","phase":"N/A","enrollment":2374,"brief_title":"Studying the Impact of Product Packaging in a Virtual Store Environment","official_title":"Studying the Impact of Product Packaging in a Virtual Store Environment","primary_completion_date":"2020-07-24","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-07-24","last_update":"2021-06-18","description":"Purpose: Examine the impact of nutrition claims on parents' decisions to purchase fruit drinks in a randomized controlled trial in an online virtual convenience store (task 1) and examine the impact of added sugar warnings on parents' snack purchasing decisions in a randomized controlled trial in an online virtual convenience store. Participants: Participants will consist of approximately 2,500 individuals 18 and older with at least one child ages 1-5. The child 1-5 who had their birthday most recently must have consumed at least one fruit drink in the previous week. Additionally, they will live in the United States and identify as non-Hispanic black, non-Hispanic white, or Hispanic. The panel research company Kantar will recruit individuals from its pool of potential individuals. Procedures (methods): The investigators will randomize participants to one of 12 versions of a virtual convenience store (iShoppe) and then the participants will complete two shopping tasks in the store. They will select two beverages (task 1) for their child 1-5 who had their birthday most recently, and they will select a snack (task 2) for that same child. After completing the shopping tasks, the participant will complete a survey in Qualtrics. The survey will ask a series of questions about the beverages and snacks (e.g., perceived healthfulness, perceived appeal, intentions to consume products). Questions will also include standard demographic and health related variables.","other_id":"19-3227","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":99,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Be 18 years or older\r\n\r\n          -  Currently reside in the US\r\n\r\n          -  Be a Kantar panel member\r\n\r\n          -  have at least one child aged 1-5\r\n\r\n          -  Child 1-5 with the most recent birthday must have consumed at least one fruit drink in\r\n             the previous week (7 days)\r\n\r\n          -  Self-identify as non-Hispanic white, non-Hispanic black, or Hispanic any race\r\n\r\n        Exclusion Criteria:\r\n\r\n        -\r\n      ","sponsor":"University of North Carolina, Chapel Hill","sponsor_type":"Other","conditions":"Obesity, Childhood","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Experimental Drink: Nutrition claim on fruit drinks","description":"Fruit drink contains a nutrition claim (task 1)"},{"intervention_type":"Behavioral","name":"Behavioral: Control Drink: No nutrition claim","description":"Fruit drinks does not contain a nutrition claim (task 1)"},{"intervention_type":"Behavioral","name":"Behavioral: Experimental snack: Text warning","description":"The snack contains a text warning (task 2)"},{"intervention_type":"Behavioral","name":"Behavioral: Experimental snack: Graphic warning","description":"The snack contains a graphic warning (task 2)"},{"intervention_type":"Behavioral","name":"Behavioral: Control snack: barcode label","description":"The snack contains a neutral barcode label (task 2)"}],"outcomes":[{"outcome_type":"secondary","measure":"Percent of Participants Who Selected Apple-flavored Fruit Drink (Fruit Drink Experimental Task 1)","time_frame":"During virtual shopping task which will last ~5 minutes","description":"Measured as percent of participants selecting apple-flavored fruit drink rather than water (objectively measured)."},{"outcome_type":"primary","measure":"Percent of Participants Who Selected the Grape-Flavored Fruit Drink (Fruit Drink Experimental Task 1)","time_frame":"During virtual shopping task which will last ~5 minutes","description":"Measured as percent of participants selecting grape-flavored fruit drink rather than 100% grape juice (objectively measured)."},{"outcome_type":"primary","measure":"Percent of Participants Who Selected the Lower Sugar Granola Snack (Snack Experimental Task 2)","time_frame":"During virtual shopping task which will last ~5 minutes","description":"Measured as percent of participants selecting lower sugar granola snack rather than higher sugar granola snack (objectively measured)."},{"outcome_type":"secondary","measure":"Percent of Participants Who Misperceive That the Fruit Drink Does Not Have Added Sugar (Fruit Drink Experimental Task 1)","time_frame":"13-15 minutes post-test computer survey following the ~5 minute virtual shopping task.","description":"The percent of participants who hold the misperception that the fruit drink does not have added sugar. Measured by response to the question, \"Do you think this beverage has added sugar?\" Response options are yes/no. Misperception coded as \"no.\""},{"outcome_type":"secondary","measure":"Percent of Participants Who Misperceive That the Fruit Drink is 100% Fruit Juice (Fruit Drink Experimental Task 1)","time_frame":"13-15 minutes post-test computer survey following the ~5 minute virtual shopping task.","description":"The percent of participants who hold the misperception that the fruit drink is 100% fruit juice. Measured by response to the question, \"Do you think this beverage is 100% fruit juice?\" Response options are yes/no. Misperception coded as \"yes.\""},{"outcome_type":"secondary","measure":"Number of Teaspoons of Added Sugar Participants Think the Fruit Drink Contains (Fruit Drink Experimental Task 1)","time_frame":"13-15 minutes post-test computer survey following the ~5 minute virtual shopping task.","description":"Amount of added sugar people think the product contains. Measured by response to the questions, \"A can of regular soda contains 8 teaspoons of added sugar. How many teaspoons of added sugar do you think this beverage has?\" Response is free text entry limited to 0-100 (# of teaspoons). This question is only asked if the participant believes the product has added sugar (see outcome 3)."},{"outcome_type":"secondary","measure":"Mean Percent of Fruit Juice That Participants Believe the Fruit Drink Contains (Fruit Drink Experimental Task 1)","time_frame":"13-15 minutes post-test computer survey following the ~5 minute virtual shopping task.","description":"The mean percentage of fruit juice participants think the product contains. Measured by response to the question, \"What percentage of this beverage do you think is fruit juice?\" Response is a sliding scale 0 - 100 (percent fruit juice). This question is only asked if the participant does not believe the drink is 100% fruit juice (see outcome 4)."},{"outcome_type":"secondary","measure":"Perceived Misleadingness of Fruit Drink (Fruit Drink Experimental Task 1)","time_frame":"13-15 minutes post-test computer survey following the ~5 minute virtual shopping task.","description":"Perceived misleadingness of the fruit drink as determined by asking the question, \"This beverage is 20% fruit juice and contains 39 grams of added sugar. How misleading do you think the information on this product is?\" The response options are on a scale: 1 = Not at all misleading…5 = Extremely misleading."},{"outcome_type":"secondary","measure":"Perceived Product Healthfulness of Fruit Drink for Child's Daily Consumption (Fruit Drink Experimental Task 1)","time_frame":"13-15 minutes post-test computer survey following the ~5 minute virtual shopping task.","description":"Perceived product healthfulness as determined by asking the question, \"How healthy or unhealthy would it be for [child you shopped for] to drink this beverage every day?\" The response options are on a scale: 1 = Very unhealthy...5= Very healthy."},{"outcome_type":"secondary","measure":"Interest in Giving the Fruit Drink to One's Child (Fruit Drink Experimental Task 1)","time_frame":"13-15 minutes post-test computer survey following the ~5 minute virtual shopping task.","description":"Interest in giving fruit drinks to one's child as determined by asking the question, \"How likely would you be to give this beverage to your child?\" The response options are on a scale: 1 = Not at all likely…5 = Extremely likely)"},{"outcome_type":"secondary","measure":"Perceived Appeal of Fruit Drink (Fruit Drink Experimental Task 1)","time_frame":"13-15 minutes post-test computer survey following the ~5 minute virtual shopping task.","description":"Perceived appeal of fruit drink as determined by asking the question, \"How appealing would your child find this beverage?\" The response options are on a scale: 1 = Very unappealing…5=Very appealing."},{"outcome_type":"secondary","measure":"Interest in Consuming the Fruit Drink (Fruit Drink Experimental Task 1)","time_frame":"13-15 minutes post-test computer survey following the ~5 minute virtual shopping task.","description":"Interest in consuming the fruit drink as determined by asking the questions, \"How likely would you be to drink. this beverage?\" The response options are on a scale: 1 = Not at all likely…5= Extremely likely."},{"outcome_type":"secondary","measure":"Relative Harm of the Fruit Drink Compared to Soda (Fruit Drink Experimental Task 1)","time_frame":"13-15 minutes post-test computer survey following the ~5 minute virtual shopping task.","description":"Relative harm of the fruit drink compared to soda as determined by asking the question, \"Compared to regular (non-diet) soda, this beverage is…\" The response options are on a scale: 1 = Much less healthy…5 = Much healthier."},{"outcome_type":"secondary","measure":"Relative Harm of the Fruit Drink Compared to 100% Fruit Juice (Fruit Drink Experimental Task 1)","time_frame":"13-15 minutes post-test computer survey following the ~5 minute virtual shopping task.","description":"Relative harm of the fruit drink compared to 100% fruit juice as determined by asking the question, \"Compared to 100% fruit juice, this beverage is…\" The response options are on a scale: 1 = Much less healthy…5 = Much healthier."},{"outcome_type":"secondary","measure":"Perceived Product Healthfulness of Snack (Snack Experimental Task 2)","time_frame":"13-15 minutes post-test computer survey following the ~5 minute virtual shopping task.","description":"Perceived product healthfulness of the snack as determined by asking, \"How healthy would it be for your child to eat this snack every day?\" The response options are on a scale: 1=very unhealthy…5=very healthy."},{"outcome_type":"secondary","measure":"Product Appeal of Snack for One's Child (Snack Experimental Task 2)","time_frame":"13-15 minutes post-test computer survey following the ~5 minute virtual shopping task.","description":"Product appeal of the snack as determined by asking, \"How appealing would your child find this snack?\" The response options are on a scale: 1=very unappealing…5=very appealing."},{"outcome_type":"secondary","measure":"Participant Intentions to Give Snack to One's Child (Snack Experimental Task 2)","time_frame":"13-15 minutes post-test computer survey following the ~5 minute virtual shopping task.","description":"Intentions to give snack to child as determined by asking, \"How likely would you be to give this snack to your child?\" The response options are on a scale: 1=not at all likely…5=extremely likely."},{"outcome_type":"secondary","measure":"Intentions to Purchase the Snack (Snack Experimental Task 2)","time_frame":"13-15 minutes post-test computer survey following the ~5 minute virtual shopping task.","description":"Intentions to purchase snack as determined by asking, \"How likely would you be to buy this snack in the next week?\" The response options are on a scale: 1=not at all likely…5=extremely likely."},{"outcome_type":"secondary","measure":"Intentions to Consume the Snack (Snack Experimental Task 2)","time_frame":"13-15 minutes post-test computer survey following the ~5 minute virtual shopping task.","description":"Intentions to consume snack as determined by asking, \"How likely would you be to consume this snack?\" The response options are on a scale: 1=not at all likely….5=extremely likely."},{"outcome_type":"secondary","measure":"Percent of Participants Able to Identify the Healthier Snack (Snack Experimental Task 2)","time_frame":"13-15 minutes post-test computer survey following the ~5 minute virtual shopping task.","description":"Correct identification of healthier snack, as measured by response to the question \"Which of these snacks would be healthier for your child?\" Response options include the snack product with the added sugar warning and the snack product without the sugar warning.\r\nsnack without the added sugar warning = healthier snack"},{"outcome_type":"secondary","measure":"Percent of Participants Able to Identify the Snack With Higher Amount of Added Sugar (Snack Experimental Task 2)","time_frame":"13-15 minutes post-test computer survey following the ~5 minute virtual shopping task.","description":"Correct identification of snack with higher added sugar, as measured by response to the question \"Which of these snacks is higher in added sugar?\" Response options include the snack product with the added sugar warning and the snack product without the sugar warning.\r\nsnack with added sugar warning = snack with higher amount of added sugar"},{"outcome_type":"secondary","measure":"Percent of Participants Who Intend to Purchase the Snack With Higher Added Sugar (Snack Experimental Task 2)","time_frame":"13-15 minutes post-test computer survey following the ~5 minute virtual shopping task.","description":"Intentions to purchase snack with higher added sugar, as measured by response to the question, \"Which of these snacks would you most want to buy for your child?\" Response options include the snack product with the added sugar warning and the snack product without the sugar warning.\r\nsnack with added sugar warning = snack with higher amount of added sugar"},{"outcome_type":"secondary","measure":"Perceived Message Effectiveness of Snack (Snack Experimental Task 2)","time_frame":"13-15 minutes post-test computer survey following the ~5 minute virtual shopping task.","description":"Perceived message effectiveness as measured by average response to three questions:\r\nHow much does this label make you concerned about the health effects of consuming this product? The response options are on a scale: 1=not at all…5=a great deal.\r\nHow much does this label make consuming this product seem unpleasant to you? The response options are on a scale: 1=not at all…5=a great deal.\r\nHow much does this label discourage you from wanting to consume this product? The response options are on a scale: 1=not at all…5=a great deal."},{"outcome_type":"secondary","measure":"Social Reactions to Snack (Snack Experimental Task 2)","time_frame":"13-15 minutes post-test computer survey following the ~5 minute virtual shopping task.","description":"Anticipated social reactions as measured by response to questions, \"How likely are you to talk about this label with others in the next week?\" The response options are on a scale: 1= not at all likely…5=extremely likely."},{"outcome_type":"secondary","measure":"Percent of Participants Who Learned Something New About the Snack (Snack Experimental Task 2)","time_frame":"13-15 minutes post-test computer survey following the ~5 minute virtual shopping task.","description":"Percent who learned something new about the snack as measured by the question, \"Did you learn something new from this label\" The response options are yes/no. Yes indicates the participant learned something new."},{"outcome_type":"secondary","measure":"Snack Grabbed the Participant's Attention (Snack Experimental Task 2)","time_frame":"13-15 minutes post-test computer survey following the ~5 minute virtual shopping task.","description":"The extent to which the snack grabbed the participant's attention as measured by the question, \"How much does this label grab your attention?\" The response options are on a scale:1=not at all…5=a great deal."},{"outcome_type":"secondary","measure":"Label on Snack Makes Participant Feel Scared (Snack Experimental Task 2)","time_frame":"13-15 minutes post-test computer survey following the ~5 minute virtual shopping task.","description":"The extent to which the snack made the participant feel scared as measured by the questions, \"How much does this label make you feel scared?\" The response options are on a scale: 1=not at all…5=a great deal."},{"outcome_type":"secondary","measure":"Thinking About the Health Effects of the Snack (Snack Experimental Task 2)","time_frame":"13-15 minutes post-test computer survey following the ~5 minute virtual shopping task.","description":"The extent to which the snack made the participant think about the health effects of the snack as measured by the question, \"How much does this label make you think about the health problems caused by eating this snack?\" The response options are on a scale: 1=not at all…5=a great deal."}]}
{"nct_id":"NCT04384965","start_date":"2020-05-12","phase":"N/A","enrollment":200,"brief_title":"Accelerated iTBS for Depressed Patients During the COVID-19 Pandemic","official_title":"A Novel and Practical Accelerated Intermittent Theta Burst Protocol as a Substitute for Depressed Patients Needing Electroconvulsive Therapy During the COVID-19 Pandemic","primary_completion_date":"2022-05-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-11-01","last_update":"2021-02-15","description":"The current study aims to assess the feasibility, acceptance and clinical outcomes of a practical high-dose aiTBS protocol, including tapering treatments and symptom-based relapse prevention treatments, in patients with unipolar depression previously responsive to ECT and patients needing urgent treatment due to symptom severity during the COVID-19 pandemic.","other_id":"059/2020","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Have unipolar depressive episode based on the MINI with or without psychotic symptoms\r\n\r\n          -  Have previous response to ECT or high symptom severity warranting acute ECT in the\r\n             opinion of a consultant brain stimulation psychiatrist\r\n\r\n          -  Are over the age of 18\r\n\r\n          -  Pass the TMS adult safety screening (TASS) questionnaire\r\n\r\n          -  Are voluntary and competent to consent to treatment\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Have a Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of\r\n             substance dependence or abuse within the last 1 month\r\n\r\n          -  Have a concomitant major unstable medical illness, cardiac pacemaker or implanted\r\n             medication pump\r\n\r\n          -  Have a lifetime Mini-International Neuropsychiatric Interview (MINI) diagnosis of\r\n             bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform\r\n             disorder, delusional disorder\r\n\r\n          -  Have any significant neurological disorder or insult including, but not limited to:\r\n             any condition likely to be associated with increased intracranial pressure, space\r\n             occupying brain lesion, any history of seizure except those therapeutically induced by\r\n             ECT or a febrile seizure of infancy or single seizure related to a known drug related\r\n             event, cerebral aneurysm, or significant head trauma with loss of consciousness for\r\n             greater than 5 minutes\r\n\r\n          -  have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear\r\n             implants, or electrodes) or any other metal object within or near the head, excluding\r\n             the mouth, that cannot be safely removed\r\n\r\n          -  currently take more than lorazepam 2 mg daily (or equivalent) or any dose of an\r\n             anticonvulsant due to the potential to limit rTMS efficacy\r\n\r\n          -  Lack of response to accelerated course of iTBS or rTMS in the past\r\n      ","sponsor":"Centre for Addiction and Mental Health","sponsor_type":"Other","conditions":"Major Depressive Disorder","interventions":[{"intervention_type":"Device","name":"Device: MagPro X100 Stimulator, B70 Fluid-Cooled Coil","description":"Treatment will occur 8 times per treatment day (50 min pause between treatments). Each treatment session will consist of a single iTBS treatment, delivering 600 pulses of iTBS (bursts of 3 pulses at 50 Hz, bursts repeated at 5 Hz, with a duty cycle of 2 seconds on, 8 seconds off, over 60 cycles / ~3 minutes) at a target of 110% of the subject's resting MT."}],"outcomes":[{"outcome_type":"secondary","measure":"Change on BDI-II","time_frame":"Up to 10 days (From screening/baseline to end of the acute treatment)","description":"changes in scores"},{"outcome_type":"secondary","measure":"Remission on Beck Scale for Suicidal Ideation (SSI)","time_frame":"Up to 10 days (From screening/baseline to end of the acute treatment)","description":"Score of 0"},{"outcome_type":"primary","measure":"Proportion achieving remission on Hamilton Rating Scale for Depresion 24-it (HRSD-24)","time_frame":"Up to 10 days (From screening/baseline to end of the acute treatment)","description":"Less than or equal to 10"},{"outcome_type":"secondary","measure":"Change in HRSD-24","time_frame":"Up to 10 days (From screening/baseline to end of the acute treatment)","description":"changes in scores"},{"outcome_type":"secondary","measure":"Response on HRSD-24","time_frame":"Up to 10 days (From screening/baseline to end of the acute treatment)","description":"50% Reduction in score"},{"outcome_type":"secondary","measure":"Remission on Patient Health Questionnaire (PHQ-9)","time_frame":"Up to 10 days (From screening/baseline to end of the acute treatment)","description":"Less than or equal to 4"},{"outcome_type":"secondary","measure":"Response on PHQ-9","time_frame":"Up to 10 days (From screening/baseline to end of the acute treatment)","description":"50% Reduction in score"},{"outcome_type":"secondary","measure":"Change in PHQ-9","time_frame":"Up to 10 days (From screening/baseline to end of the acute treatment)","description":"changes in scores"},{"outcome_type":"secondary","measure":"Remission on General Anxiety Disorder 7 item (GAD-7)","time_frame":"Up to 10 days (From screening/baseline to end of the acute treatment)","description":"Less than or equal to 4"},{"outcome_type":"secondary","measure":"Response on GAD-7","time_frame":"Up to 10 days (From screening/baseline to end of the acute treatment)","description":"50% Reduction in score"},{"outcome_type":"secondary","measure":"Change in GAD-7","time_frame":"Up to 10 days (From screening/baseline to end of the acute treatment)","description":"changes in scores"},{"outcome_type":"secondary","measure":"Remission on Beck Depression Inventory (BDI-II)","time_frame":"Up to 10 days (From screening/baseline to end of the acute treatment)","description":"Less than or equal to 12"},{"outcome_type":"secondary","measure":"Response on BDI-II","time_frame":"Up to 10 days (From screening/baseline to end of the acute treatment)","description":"50% Reduction in Score"},{"outcome_type":"secondary","measure":"Change on SSI","time_frame":"Up to 10 days (From screening/baseline to end of the acute treatment)","description":"changes in scores"},{"outcome_type":"secondary","measure":"Change in WHO Disability Assessment Schedule (WHODAS)","time_frame":"Up to 10 days (From screening/baseline to end of the acute treatment)","description":"changes in scores"},{"outcome_type":"secondary","measure":"Proportion of Patients Maintaining Response During Relapse Prevention","time_frame":"24 weeks (Tapering and Relapse prevention phase)","description":"Includes number of treatment days needed and number going on to receive ECT"}]}
{"nct_id":"NCT04840966","start_date":"2020-05-05","enrollment":111,"brief_title":"A Simplified Test to Assess Flavor in COVID-19 Patients","official_title":"Simplified Flavor Test for Self-administation in COVID-19 Positive Patients","primary_completion_date":"2021-01-15","study_type":"Observational","rec_status":"Completed","completion_date":"2021-01-15","last_update":"2021-04-15","description":"The Flavor test has been developed and validated by our group to assess retro-nasal olfactory performances. The original flavor test has been simplified, with the great advantage to be self-administrable for COVID-19 patients in isolation, without any risk to health professionals.","other_id":"PM0001/2020","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"A total of 111 subjects (19 hospitalized [HOS] and 37 home-isolated [HI] COVID-19 patients,\r\n        and 55 healthy controls [CTRL]) were enrolled in the study. The mean age for overall\r\n        population was 41.5214.45 years.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adults (18 years of age) that gave their written informed consent to the study\r\n\r\n          -  Diagnosis of COVID-19 was confirmed by PCR of nasopharyngeal swab (HI or HOS)\r\n\r\n          -  Negative COVID-19 nasopharyngeal swab (CTRL)\r\n\r\n          -  Subjects with no critical conditions and able to understand the protocol\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  nasal obstruction or previous nasal diseases\r\n      ","sponsor":"Federico II University","sponsor_type":"Other","conditions":"Covid19","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Flavor test","description":"A simplified self-administrable flavor test has been proposted to all the enrolled subjects"},{"intervention_type":"Other","name":"Other: Self-assesment questionnaire","description":"Questionnaire to score subjective chemosensory function (smell and flavor) before and after COVID-19 using a 0-10 scale with 0 corresponding to \"no smell/flavor perception\" and 10 corresponding to \"excellent smell/flavor perception\"."}],"outcomes":[{"outcome_type":"primary","measure":"Flavor perception","time_frame":"Apr, 2020- Jan, 2021","description":"To assess qualitative flavor perception"},{"outcome_type":"secondary","measure":"Flavor perception intensity","time_frame":"Apr, 2020- Jan, 2021","description":"To assess quantitative flavor perception"},{"outcome_type":"other","measure":"Comparison with self-estimated flavor perception","time_frame":"Apr, 2020- Jan, 2021","description":"To compare results of the test with self-assessed flavor and smell perception"}]}
{"nct_id":"NCT04418609","start_date":"2020-05-01","enrollment":30,"brief_title":"Neuro-COVID-19: Neurological Complications of COVID-19","official_title":"Neuro-COVID-19: Neurological Complications of COVID-19","primary_completion_date":"2022-04-30","study_type":"Observational","rec_status":"Recruiting","completion_date":"2022-05-30","last_update":"2020-06-05","description":"The prevalence and typical patterns of neurological complications in hospitalized COVID-19 patients admitted to the intensive care units of the University Hospital Zurich will be investigated. The impact of neurological complications among COVID-19 patients on mortality, functional outcome, and organizational outcomes will be analyzed.","other_id":"Neuro-COVID-19","observational_model":"Cohort","time_perspective":"Other","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"All patients admitted to the Intensive Care Units (ICUs) of the Institute of Intensive Care\r\n        Medicine, University Hospital of Zurich meeting eligibility criteria during the pandemic\r\n        will be enrolled.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adults (age > 18 years old) treated at ICUs\r\n\r\n          -  Admitted with confirmed COVID-19 infection\r\n\r\n          -  Patient exhibiting acute neurological manifestations\r\n\r\n          -  General consent of the Institute of Intensive Care Medicine available from patient or\r\n             legal representative\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pre-existing severe neurologic dysfunction\r\n      ","sponsor":"Emanuela Keller","sponsor_type":"Other","conditions":"Neurologic Complication","interventions":[{"intervention_type":"Other","name":"Other: further processing of health data","description":"further processing of biological materials and health related personal data for research"}],"outcomes":[{"outcome_type":"primary","measure":"Prevalence of neurological complications","time_frame":"through study completion, on an average of 3 weeks","description":"Determine the prevalence of neurological complications in hospitalized COVID-19 patients admitted to the intensive care unit."},{"outcome_type":"primary","measure":"Prevalence and outcome of severe neurological complications","time_frame":"through study completion, on an average of 3 weeks","description":"Examine if empiric COVID-19 therapies are associated with difference in the prevalence and outcome of severe neurological complications of COVID-19."},{"outcome_type":"primary","measure":"Impact of neurological complications","time_frame":"through study completion, on an average of 3 weeks","description":"Determine the impact of neurological complications among COVID-19 patients on mortality, functional outcome, and organizational outcomes (ICU length of stay, hospital length of stay) among patients with confirmed COVID-19."},{"outcome_type":"primary","measure":"Characteristic patterns in cerebral imaging and electroencephalography (EEG), as well as cerebrospinal fluid (CSF)","time_frame":"through study completion, on an average of 3 weeks","description":"Analyze characteristic patterns in cerebral imaging and electroencephalography (EEG), as well as cerebrospinal fluid (CSF) of patients, in whom a lumbar puncture has been performed for clinical reasons"},{"outcome_type":"primary","measure":"Brain for pathological changes and histopathological findings (if patient dies).","time_frame":"through study completion, on an average of 3 weeks","description":"Analyze the brain for pathological changes and histopathological findings, if the patient dies."}]}
{"nct_id":"NCT04302467","start_date":"2020-05-01","phase":"N/A","enrollment":276,"brief_title":"Effects of Intraoperative Fluid Therapy on Acute Kidney Injury After Thoracoscopic Lobectomy","official_title":"Effects of Goal-directed Fluid Therapy and Restrictive Fluid Therapy During Operation Combined With Enhanced Recovery After Surgery Protocol on Acute Kidney Injury After Thoracoscopic Lobectomy in High Risk Patients","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-12-31","last_update":"2021-08-26","description":"Background: Acute kidney injury (AKI) often occurs after thoracoscopic lobectomy in high risk patients. Insufficient intraoperative infusion is risk factor of AKI. Goal-directed fluid therapy (GDFT) is individualized fluid infusion strategy, the infusion rate and type is adjusted according to the individual's fluid response. GDFT during operation can reduce the incidence of AKI after major surgery. Enhanced recovery after surgery (ERAS) integrates a range of perioperative interventions to decrease postoperative complications after surgery. In ERAS protocol of lobectomy, restrictive fluid therapy during operation is recommended. In this study, the investigators will compare the effects of GDFT and restrictive fluid therapy during operation combined with ERAS protocol on the incidence of AKI after thoracoscopic lobectomy in high risk patients. Methods/design: This is prospective single-center single-blind randomized controlled trial. 276 patients scheduled to undergo thoracoscopic lobectomy under general anesthesia combined with paravertebral block are randomly divided into GDFT group and restrictive fluid therapy group at a 1:1 ratio. The primary outcome is the incidence of AKI after operation. The secondary outcomes are (1) the incidence of renal replacement therapy, (2) length of intensive care unit (ICU) stay after operation, (3) length of hospital stay after operation , (4) incidence of other complications including: infection, acute lung injury (ALI), pneumonia, arrhythmia, heart failure, myocardial injury after noncardiac surgery (MINS), cardiac infarction. Discussion: This is the first study to compare GDFT and restrictive fluid therapy during operation combined with ERAS protocol on the incidence of AKI after thoracoscopic lobectomy in high risk patients. The investigators expected that the two methods have the same effect on the incidence of AKI, but restrictive fluid therapy is simpler to applied than GDFT.","other_id":"XJTU1AF-CRF-2019-012","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Triple","intervention_model_description":"Participants will be randomly allocated to one of the two groups: (1) GDFT group and (2) restrictive fluid therapy group. They will be allocated in a 1:1 ratio using random numbers generated by Microsoft Excel.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria: patients comply any of the following criteria will be enrolled\r\n\r\n          -  Age>70 years old\r\n\r\n          -  Forced expiratory volume in 1 second (FEV1)<60%\r\n\r\n          -  Carbon monoxide lung diffusion capacity (DLCO)<60%\r\n\r\n          -  History of coronary artery disease\r\n\r\n        Exclusion Criteria: patients comply any of the following criteria may not be enrolled\r\n\r\n          -  Patients refused\r\n\r\n          -  Creatinine>176 mol/L, and/or BUN>7.1 mmol/L\r\n\r\n          -  NT-proBNP>300 ng/L\r\n\r\n          -  Systemic or local infection\r\n\r\n          -  Albumin<30 g/L, and/or Hemoglobin<100 g/L\r\n\r\n          -  Allergy to hydroxyethyl starch\r\n      ","sponsor":"First Affiliated Hospital Xi'an Jiaotong University","sponsor_type":"Other","conditions":"Acute Kidney Injury","interventions":[{"intervention_type":"Procedure","name":"Procedure: fluid therapy during operation","description":"ERAS protocol of lobectomy will implemented to all the participants during perioperation,two groups of participants will be given different intraoperative fluid therapy strategy."}],"outcomes":[{"outcome_type":"primary","measure":"number of participants with acute kidney injury","time_frame":"48 hours after operation","description":"50% relative or 0.3 mg/dl (26.5 μmol/L) absolute increase in creatinine over the preoperative value during the first two postoperative days."},{"outcome_type":"secondary","measure":"number of participants in need of renal replacement therapy","time_frame":"30 days after operation","description":"Patients who need renal replacement therapy, the indications of renal replacement therapy will be determined by clinician"},{"outcome_type":"secondary","measure":"length of ICU stay after operation","time_frame":"30 days after operation","description":"from the end of operation to ICU discharge"},{"outcome_type":"secondary","measure":"length of hospital stay after operation","time_frame":"30 days after operation","description":"from the end of operation to discharge"},{"outcome_type":"secondary","measure":"number of participants with infection","time_frame":"30 days after operation","description":"Patients with postoperative infection, including: wound infection, urinary tract infection, systemic infection"},{"outcome_type":"secondary","measure":"number of participants with acute lung injury","time_frame":"24 hours after operation","description":"Oxygen partial pressure/fraction of inhaled oxygen(PaO2/FiO2)<300 mmHg 24 hours after operation, bilateral lung infiltration, exclude cardiogenic pulmonary edema."},{"outcome_type":"secondary","measure":"number of participants with pneumonia","time_frame":"30 days after operation","description":"new or progressive and persistent infiltrates, consolidation, cavitation. And at least one of the following: (1) fever (>38℃) with no other recognised cause, (2) white cell count<4×109/L or >12×109/L, (3) altered mental status with no other recognised cause for patients more than 70 years old. And at least two of the following:(1) new onset of purulent sputum or change in character of sputum, or increased respiratory secretions, or increased suctioning requirements, (2) new onset or worsening cough, or dyspnea, or tachypnea, (3) rales or bronchial breath sounds, (4) worse gas exchange."},{"outcome_type":"secondary","measure":"number of participants with arrhythmia","time_frame":"48 hours after operation","description":"patients who have new-onset arrhythmia 48 hours after operation"},{"outcome_type":"secondary","measure":"number of participants with heart failure","time_frame":"48 hours after operation","description":"NT-proBNP is more than 450 ng/L if age less than 50, or NT-proBNP is more than 900 ng/L if age more than 50."},{"outcome_type":"secondary","measure":"number of participants with myocardial injury after noncardiac surgery","time_frame":"7 days after operation","description":"troponin T is more than 0.03 ng/ml and/or creatine kinase-MB is more than 8.8 ng/ml."},{"outcome_type":"secondary","measure":"number of participants with cardiac infarction","time_frame":"48 hours after operation","description":"troponin T elevation in the presence of at least one of ischemic symptoms: (1) the development of new or presumed new Q waves, (2) ST segment or T wave changes, (3) left bundle branch block on ECG, (4) a new or presumed new regional wall motion abnormality on echocardiography."}]}
{"nct_id":"NCT03517995","start_date":"2020-04-30","phase":"Phase 2","enrollment":0,"brief_title":"Randomized, Phase II Clinical Trial of Sulforaphane in Bladder Cancer Chemoprevention","official_title":"Randomized, Phase II Clinical Trial of Sulforaphane in Bladder Cancer Chemoprevention","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2022-12-31","last_update":"2020-05-28","description":"The main purpose of this study is to see if Prostaphane is effective and can help reduce the progression of bladder cancer. Researchers also want to find out if Prostaphane is safe and tolerable, and to evaluate how Prostaphane works to reduce the progression of bladder cancer. This study will compare Prostaphane with a placebo to see if taking Prostaphane is better than taking a placebo. A placebo is a pill that looks like Prostaphane but has no drug or other active ingredients in it. The study will be presented to eligible patients by the patient's surgeon at the time when an appointment is made for cystoscopy for suspicion of bladder cancer (BC) or to confirm BC diagnosis.","other_id":"MCC-19574","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Men and women; age 18 years; evidence of non-muscle invasive or muscle invasive\r\n             primary bladder tumor (urothelial carcinoma +/- variant histology) discovered on\r\n             cystoscopy or radiologic imaging performed within 60 days of randomization; with no\r\n             evidence of distant metastases; planned Transurethral Resection+B21 (TURBT),\r\n             cystoscopy with biopsies or cystectomy (total or partial);\r\n\r\n          -  Absent prior pelvic radiation; normal organ function;\r\n\r\n          -  Absent neoadjuvant chemotherapy (refusal or ineligibility); (the participant may have\r\n             prior intravesical treatment exposure (including Bacillus Calmette-Guerin (BCG),\r\n             mitomycin, gemcitabine, valrubicin, docetaxel, etc.) for bladder cancer (BC)\r\n             (excluding primary bladder radiation therapy) provided that treatment was completed\r\n             greater than 30 days prior to the patient's randomization visit);\r\n\r\n          -  Non-smokers (urinary cotinine tested);\r\n\r\n          -  Agree to restrict dietary sources of Sulforaphane (SFN) to 3 or 5 servings/week and\r\n             abstain from consuming SFN supplements beginning three days prior to start of study\r\n             and throughout duration of the study;\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2;\r\n\r\n          -  Willing to discontinue current vitamin/mineral supplement use and substitute with a\r\n             standard multivitamin supplement provided for the study;\r\n\r\n          -  Willing to use an effective method of contraception, if the partner is of\r\n             child-bearing age, while on study;\r\n\r\n          -  Willing to comply with proposed visit and treatment schedule;\r\n\r\n          -  Able to understand and willing to sign a written informed consent document;\r\n\r\n          -  Participants must have normal organ and marrow function.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Evidence of other cancers (excluding non-melanoma skin cancer) or metastatic disease;\r\n\r\n          -  Prior pelvic radiation; concurrent systemic chemotherapy for any other cancer,\r\n             excluding non-melanoma skin cancer;\r\n\r\n          -  Any treatment for the bladder tumor other than intravesical therapy;\r\n\r\n          -  Prior treatment with a known histone deacetylase inhibitor (including but not limited\r\n             to valproic acid, suberoylanilide hydroxamic acid (SAHA), Panobinostat (LBH589), etc.)\r\n             within 6 months prior to starting study treatment or while on study therapy;\r\n\r\n          -  Current treatment with warfarin;\r\n\r\n          -  Use of dietary supplements or herbal remedies which may affect the study outcome -\r\n             unless the participant is willing to discontinue taking them for 1 month prior to\r\n             starting study;\r\n\r\n          -  Usual consumption of > 5 servings per week of brassica vegetables;\r\n\r\n          -  Gastrointestinal ailments which would interfere with the ability to adequately absorb\r\n             SFN;\r\n\r\n          -  Allergy/known intolerance to cruciferous vegetables;\r\n\r\n          -  Used antibiotics (more than 3 doses) within 10 days prior to study (day -14 prior to\r\n             study randomization);\r\n\r\n          -  Current smoker.\r\n      ","sponsor":"H. Lee Moffitt Cancer Center and Research Institute","sponsor_type":"Other","conditions":"Bladder Cancer|Bladder Tumor|Urothelial Carcinoma","interventions":[{"intervention_type":"Drug","name":"Drug: Sulforaphane Administration","description":"1 capsule (10 mg Prostaphane) taken two times per day (2 capsules, 20 mg Prostaphane total)."},{"intervention_type":"Other","name":"Other: Placebo Administration","description":"1 capsule (placebo) taken two times per day (2 capsules total)."},{"intervention_type":"Procedure","name":"Procedure: Standard of Care Surgery","description":"The study will be conducted during the time from when participants are diagnosed with bladder cancer to when they undergo a surgical procedure for the treatment or removal of their bladder cancer. The surgical procedure is done as a part of their regular medical care."}],"outcomes":[{"outcome_type":"primary","measure":"Magnitude of Change","time_frame":"Up to 30 days","description":"Magnitude of change in Intermediate Endpoint Biomarkers (IEBs) of proliferation (Ki-67 expressing cells- an independent marker of poor prognosis in bladder cancer (BC)) from baseline to end of treatment with 20 mgs Prostaphane® [Nutinov Labs, France] containing 200 μmol of Sulforaphane (SFN) a day at 3-4 weeks (maximum 30 days) in BC cells and benign/adjacent cells."},{"outcome_type":"secondary","measure":"Effectiveness of Sulforaphane vs. Placebo","time_frame":"End of study, approximately 30 days","description":"Effectiveness of SFN at this dose (vs. placebo) as indicated by modulation of other IEBs of proliferation, apoptosis and phase II enzymes, as well as the potential molecular mechanism of SFN, we will measure changes in: (i) BC histology grade; (ii) labeling index of a sensitive biomarker that is a member of DNA replication origin licensing complex, Mcm2; (iii) apoptosis (Caspase-3); (iv) Phase II enzymes (glutathione transferases, epoxide hydrolase, Nicotinamide adenine dinucleotide phosphate (NAD(P)H): quinone reductase, and glucuronosyltransferases); (v) Nrf2 and Transcription factor (NF-kB) signaling, from baseline to end of treatment in BC cells and benign/adjacent cells."},{"outcome_type":"secondary","measure":"Occurrence of Adverse Events per Study Arm","time_frame":"End of study, approximately 30 days","description":"Safety of SFN at this dose (vs. Placebo) as indicated by incidence of adverse events and toxicities, monitored using Common Toxicity Criteria version 5.0, complete blood count (CBC), and complete metabolic panel (CMP) from baseline at mid-point and at end of trial."},{"outcome_type":"secondary","measure":"Mid-study Bioavailability of Sulforaphane","time_frame":"Mid-study, approximately 15 days","description":"Bioavailability, of SFN at this dose vs. Placebo. Investigators will measure change in SFN in plasma and bladder tissue from baseline, at mid-point and at end of study."},{"outcome_type":"secondary","measure":"End of Study Bioavailability of Sulforaphane","time_frame":"End of study, approximately 30 days","description":"Bioavailability, of SFN at this dose vs. Placebo. Investigators will measure change in SFN in plasma and bladder tissue from baseline, at mid-point and at end of study."},{"outcome_type":"secondary","measure":"Adherence of Sulforaphane vs. Placebo","time_frame":"End of study, approximately 30 days","description":"Adherence based on pill counts and diet and pill logs from baseline."},{"outcome_type":"secondary","measure":"Acceptability of Sulforaphane vs. Placebo","time_frame":"End of study, approximately 30 days","description":"Acceptability based on pill counts and diet and pill logs from baseline."}]}
{"nct_id":"NCT04596098","start_date":"2020-04-30","enrollment":100,"brief_title":"Immune Responses to COVID-19; Isolation of Neutralizing Antibodies for Therapeutics and Vaccine.","official_title":"Immune Responses to COVID-19 (SARS-CoV-2 Related Infection); Isolation of Human Neutralizing Monoclonal Antibodies for Therapeutics and Vaccine Design Approaches: a Prospective Monocentric Trial With Collaborative Sample Collection.","primary_completion_date":"2021-06-30","study_type":"Observational","rec_status":"Recruiting","completion_date":"2021-09-30","last_update":"2021-01-15","description":"According to different projections, the COVID-19 outbreak currently happening in France and worldwide could result in millions of deaths in the absence of efficient therapies. The COVID-19 causative agent, the SARS-CoV-2, is a virus leading to respiratory system infections in human and for which there is currently no vaccine or treatment scientifically validated in clinical studies. In that context, therapeutic human neutralizing antibodies targeting the SARS-CoV-2 envelop glycoproteins and which enable inhibition of the viral replication represent an innovative therapeutic alternative with great potential. These antibodies are also critical tools for vaccine development. Simultaneously, CHUGA researchers coordinate with each other to set up a collective biological collection to achieve others objectives such as biomarkers identifications.","other_id":"38RC20.132","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients hospitalized in Grenoble University hospital for a COVID-19 infection for less\r\n        than 48 hours (who is not already included in a study and consent to AcNT study).","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Man or woman over 18 years old hospitalized in Grenoble University hospital for a\r\n             COVID-19 infection for less than 48 hours,\r\n\r\n          -  Symptomatic patient with an estimated hospitalization period over 7 days and requiring\r\n             regular blood sampling,\r\n\r\n          -  Patient weighing more than 60 kg.\r\n\r\n          -  Patient who has given his non-opposition/consent for AcNT study.\r\n\r\n          -  Patient affiliated toFrench Social Security System.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patient non able to consent (such as intubated patient in ICU)\r\n\r\n          -  Patient protected by the French law (defined as: minor, pregnant or breastfeeding\r\n             woman, patient under curatorship, patient deprived of liberty or hospitalized against\r\n             his/her will)\r\n\r\n          -  Patient already included in a clinical trial involving substantial blood sampling\r\n             (over 20mL a day or over 150mL a month).\r\n\r\n          -  Patient whose medical condition is not compatible with the trial (impossibility to\r\n             consent, intensive case unit, anaemia with haemoglobin under 10g/dl )\r\n      ","sponsor":"University Hospital, Grenoble","sponsor_type":"Other","conditions":"SARS-CoV 2","interventions":[{"intervention_type":"Other","name":"Other: Blood sampling","description":"During a care-related blood sampling, patient will provide additional blood sample for research purpuse."}],"outcomes":[{"outcome_type":"primary","measure":"Isolation of recombinant monoclonal neutralizing antibodies directed against SARS-CoV-2, isolated from COVID19 hospitalized patients blood probes.","time_frame":"From all blood sampling with serum (visit 1 at Day1, visit 6 at Day13 or, in b-group, visit 9 occuring between month 2 and month 6).","description":"Step 1 : Measurement of the monoclonal antibody concentration inhibiting 50% of the target cells infection (IC 50%) via a VSV virus pseudotyped with SARS-CoV-2 envelope glycoproteins. Neutralizing activity is defined with an IC 50 below 50 ug/ml."},{"outcome_type":"primary","measure":"Isolation of recombinant monoclonal neutralizing antibodies directed against SARS-CoV-2, isolated from COVID19 hospitalized patients blood probes.","time_frame":"From patient and time frame identified in step 1 described above.","description":"STEP 2 : Ability to produce monoclonal recombinant antibodies anti-SARS-CoV-2 from memory B cell (fundamental outcome : yes/no)"},{"outcome_type":"secondary","measure":"Description of biological biomarkers (cytokine, IL6) predictive of worsening","time_frame":"day 1","description":"Blood biomarkers (IL6 in ng/L measured by flow cytometry immuno-analysis) from day 1 of hospitalization will be evaluated as potential biomarker related to worsening (defined as patient transfer to ICU or death)."},{"outcome_type":"secondary","measure":"Description of biological biomarkers (cytokine, IL10) predictive of worsening","time_frame":"day 1","description":"Blood biomarkers (IL10 in ng/L measured by flow cytometry immuno-analysis) from day 1 of hospitalization will be evaluated as potential biomarker related to worsening (defined as patient transfer to ICU or death)."},{"outcome_type":"secondary","measure":"Description of biological biomarkers (Cellular immune responses, lymphocytes) predictive of worsening","time_frame":"day 1","description":"Blood biomarkers (Lymphocytes sub-populations in G/L measured by flow cytometry) from day 1 of hospitalization will be evaluated as potential biomarker related to worsening (defined as patient transfer to ICU or death)."},{"outcome_type":"secondary","measure":"Description of biological biomarkers (Cellular immune responses, monocytes) predictive of worsening","time_frame":"day 1","description":"Blood biomarkers (Monocytic HLA-DR in G/L measured by flow cytometry) from day 1 of hospitalization will be evaluated as potential biomarker related to worsening (defined as patient transfer to ICU or death)."},{"outcome_type":"secondary","measure":"Description of biological biomarkers (complement system, CH50) predictive of worsening","time_frame":"day 1","description":"Blood biomarkers (CH50 in % measured by spectrophotometry) from day 1 of hospitalization will be evaluated as potential biomarker related to worsening (defined as patient transfer to ICU or death)."},{"outcome_type":"secondary","measure":"Description of biological biomarkers (complement system, CH50a) predictive of worsening","time_frame":"day 1","description":"Blood biomarkers (CH50a in % measured by spectrophotometry) from day 1 of hospitalization will be evaluated as potential biomarker related to worsening (defined as patient transfer to ICU or death)."},{"outcome_type":"secondary","measure":"Description of biological biomarkers (complement system, C3) predictive of worsening","time_frame":"day 1","description":"Blood biomarkers (C3 in mg/L measured by nephelometry) from day 1 of hospitalization will be evaluated as potential biomarker related to worsening (defined as patient transfer to ICU or death)."},{"outcome_type":"secondary","measure":"Description of biological biomarkers (complement system, C4) predictive of worsening","time_frame":"day 1","description":"Blood biomarkers (C4 in mg/L measured by nephelometry) from day 1 of hospitalization will be evaluated as potential biomarker related to worsening (defined as patient transfer to ICU or death)."}]}
{"nct_id":"NCT04270851","start_date":"2020-04-30","enrollment":20,"brief_title":"Colorectal Liver Metastases: Novel Assessment Tools for Technical Resectability","official_title":"Colorectal Liver Metastases: Novel Assessment Tools for Technical Resectability (The CoNoR Study)","primary_completion_date":"2021-03-31","study_type":"Observational","rec_status":"Not yet recruiting","completion_date":"2021-03-31","last_update":"2020-02-17","description":"The CoNoR study aims to assess whether the use of the LiMAx test and the HepaT1ca pre-operative planning magnetic resonance scan impact upon technical resectability decision-making in colorectal liver metastases (CLM).","other_id":"IRAS ID 266961","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":16,"population":"Patients with histologically verified adenocarcinoma of the colon or rectum and\r\n        radiological evidence of liver metastases","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patients over 16 years of age with histologically verified adenocarcinoma of the colon\r\n             or rectum and radiological evidence of liver metastases\r\n\r\n          2. Discussion at regional hepatobiliary multidisciplinary team meeting\r\n\r\n          3. Hepatobiliary surgical opinion that their case represents a potentially difficult\r\n             decision regarding technical resectability\r\n\r\n          4. Ability to provide written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Presence of a medical or psychiatric condition impairing the ability to give informed\r\n             consent\r\n\r\n          2. Presence of any other serious uncontrolled medical condition\r\n\r\n          3. Patients under 16 years old\r\n\r\n          4. Contra-indications to magnetic resonance scanning\r\n      ","sponsor":"University of Manchester","sponsor_type":"Other","conditions":"Cancer|Cancer Metastatic|Colorectal Cancer|Liver Metastasis Colon Cancer","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: LiMAx test","description":"The LiMAx test is a fully licenced liver function test, testing liver maximum capacity via a breath test."},{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: HepaT1ca magnetic resonance scan","description":"The HepaT1ca scan is a pre-operative magnetic resonance scan providing a detailed report permitting interactive virtual pre-operative planning prior to liver surgery."}],"outcomes":[{"outcome_type":"primary","measure":"Change in decision making on technical resectability","time_frame":"One year","description":"Liver surgeons will view the standard pre-operative assessment results and decide if each case scenario is 'technically resectable.' They will then view the results from these two additional pre-operative tests (LiMAx and HepaT1ca), and decide again. We will measure for any change in decision making after viewing the novel test results."},{"outcome_type":"secondary","measure":"Change in operative plan","time_frame":"One Year","description":"Liver surgeons will view the standard pre-operative assessment results and specify their operative plan for each clinical scenario. They will then view the results from these two additional pre-operative tests (LiMAx and HepaT1ca), and specify their operative plan again. We will measure for any change in decision making in their operative plan after viewing the novel test results."},{"outcome_type":"secondary","measure":"Level of agreement between liver surgeons on technical resectability","time_frame":"One Year","description":"For all participating surgeons, we will measure the level of agreement between them when they decide if each case scenario is technically resectable."}]}
{"nct_id":"NCT03579329","start_date":"2020-04-30","enrollment":58,"brief_title":"Effect of Total Knee Arthroplasty on Sarcopenia in Patients With Osteoarthritis in the Knee","official_title":"Effect of Total Knee Arthroplasty on Sarcopenia in Patients With Osteoarthritis in the Knee","primary_completion_date":"2020-12-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2021-06-30","last_update":"2020-06-16","description":"Sarcopenia is a wasting disease with the locomotion system in the aged population. It is defined as the decline in muscle mass (lean body mass) and strength with the advance of age. The prevalence of sarcopenia increases with age, reaching an astounding 50% among the population aged over 75 in the United States. Sarcopenia is often associated with frailty, falls, and disability. Studies have found sarcopenia can be a predicting risk factor for fractures in the elderly. In addition, sarcopenia predicted a higher chance of mortality in nursing homes.","other_id":"2015.539","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"End stage knee osteoarthritis","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male and Female aged over 18 wirh end stage knee OA\r\n\r\n          -  Scheduled for TKA\r\n\r\n          -  Agree to provide written consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of alcoholism or drug abuse\r\n\r\n          -  Pregnancy and breast-feeding\r\n\r\n          -  Presence of serious pathologies\r\n\r\n          -  Steroid-based systemic therapy in progress or interrupted since less than 1 month\r\n\r\n          -  With significant hematologic diseases\r\n      ","sponsor":"Chinese University of Hong Kong","sponsor_type":"Other","conditions":"Sarcopenia|Osteoarthritis, Knee","interventions":[{"intervention_type":"Procedure","name":"Procedure: Total Knee Arthroplasty","description":"Effect of Total Knee Arthroplasty on Sarcopenia in Patients with Osteoarthritis in the Knee"}],"outcomes":[{"outcome_type":"primary","measure":"International Physical Activity Questionnaire (IPAQ)","time_frame":"one year","description":"Questionnaire"},{"outcome_type":"primary","measure":"DXA scan","time_frame":"one year","description":"Lean Muscle Mass Index"},{"outcome_type":"secondary","measure":"Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)","time_frame":"one year","description":"Questionnaire"},{"outcome_type":"secondary","measure":"Self-Rated 12","time_frame":"one year","description":"Questionnaire"}]}
{"nct_id":"NCT04356950","start_date":"2020-04-28","enrollment":175,"brief_title":"Analysis of the Coagulopathy Developed by COVID-19 Infected Patients","official_title":"Analysis of the Coagulopathy Developed by COVID-19 Infected Patients: Thrombin Generation Potential in COVID-19 Infected Patients","primary_completion_date":"2022-04-30","study_type":"Observational","rec_status":"Active, not recruiting","completion_date":"2022-07-31","last_update":"2021-01-22","description":"Increased D-dimers at admission of COVID-19 infected patients entering hospital due to a severe disease is a risk factor for death. Understanding this acquired coagulopathy is a prerequisite before specific interventional studies. The study investigators aim to apply a normalized and automated thrombin generation test (TGT), developed for testing the thrombotic risk (triggered by 5 pM Tissue Factor, with a purified thrombomodulin (TM) challenge) and to study its association with survival.","other_id":"PHRC-I/2020/JCG-01","observational_model":"Other","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Consecutive patients hospitalized for SARS-CoV-2 infection with symptomatology / severity\r\n        requiring hospital treatment.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patient with SARS-CoV-2 infection entering hospitalization with or without\r\n             resuscitation\r\n\r\n          -  The patient (or their carer) must have given their free and informed consent and\r\n             signed the consent form\r\n\r\n          -  The patient must be a member or beneficiary of a health insurance plan\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnant or breastfeeding patient\r\n\r\n          -  It is impossible to give the subject informed information\r\n\r\n          -  The patient is under safeguard of justice or state guardianship\r\n\r\n          -  Thrombotic events during treatment: flare-up of venous thromboembolism, flare-up of\r\n             atherothrombosis.\r\n\r\n          -  Long-term anticoagulant treatment (anti-vitamin K, direct oral anticoagulant).\r\n\r\n          -  Chronic anti-aggregation treatment.\r\n\r\n          -  Pre-existing constitutive or acquired known coagulation pathology: hemorrhagic\r\n             diseases (thrombocytopenia, thrombocytopathy, hemophilia, von Willebrand's disease,\r\n             hemorrhagiparous factor deficiency), and for thrombophilia (deficits in antithrombin,\r\n             protein C or S , Factor V Leiden or Prothrombin 20201A mutation).\r\n      ","sponsor":"Centre Hospitalier Universitaire de Nmes","sponsor_type":"Other","conditions":"Sepsis|Blood Coagulation Disorders|Thrombin|Disseminated Intravascular Coagulation|COVID-19","interventions":[{"intervention_type":"Other","name":"Other: Thrombin generation test assay","description":"lag time, initial velocity, time-to-peak, thrombin peak, total thrombin generation time, extrinsic thrombin potential (ETP). Crude quantitative values and relative values (%, by reference to the one obtained with an invariant reference plasma). Both without the addition of purified thrombomodulin (TM-) and with the addition of purified thrombomodulin (TM+). The ability of TM to inhibit thrombin generation will be calculated as follows: [ETP (%)(TM+) / ETP (%)(TM-)]."},{"intervention_type":"Other","name":"Other: Fibrin generation markers assays","description":"D-dimers (coagulation plus fibrinolysis), soluble fibrin monomers (coagulation only)"}],"outcomes":[{"outcome_type":"primary","measure":"28-day survival rate","time_frame":"1 month","description":"Death yes/no during hopstilization, 28 days after admittence"},{"outcome_type":"primary","measure":"Absolute thrombin generation test latent period","time_frame":"Day 0","description":"Seconds; without (TM-) and with (TM+) purified thrombomodulin"},{"outcome_type":"primary","measure":"Relative thrombin generation test latent period compared to reference plasma","time_frame":"Day 0","description":"%; without (TM-) and with (TM+) purified thrombomodulin"},{"outcome_type":"primary","measure":"Absolute thrombin generation test initial velocity","time_frame":"Day 0","description":"nmol/s; without (TM-) and with (TM+) purified thrombomodulin"},{"outcome_type":"primary","measure":"Relative thrombin generation test initial velocity compared to reference plasma","time_frame":"Day 0","description":"%; without (TM-) and with (TM+) purified thrombomodulin"},{"outcome_type":"primary","measure":"Relative thrombin generation test peak thrombin compared to reference plasma","time_frame":"Day 0","description":"%; without (TM-) and with (TM+) purified thrombomodulin"},{"outcome_type":"primary","measure":"Absolute thrombin generation test peak thrombin","time_frame":"Day 0","description":"nmol/L; without (TM-) and with (TM+) purified thrombomodulin"},{"outcome_type":"primary","measure":"Absolute thrombin generation test peak thrombin time","time_frame":"Day 0","description":"Seconds; without (TM-) and with (TM+) purified thrombomodulin"},{"outcome_type":"primary","measure":"Relative thrombin generation test peak thrombin time compared to reference plasma","time_frame":"Day 0","description":"%; without (TM-) and with (TM+) purified thrombomodulin"},{"outcome_type":"primary","measure":"Absolute thrombin generation test total thrombin generation time","time_frame":"Day 0","description":"seconds; without (TM-) and with (TM+) purified thrombomodulin"},{"outcome_type":"primary","measure":"Relative thrombin generation test total thrombin generation time compared to reference plasma","time_frame":"Day 0","description":"%; without (TM-) and with (TM+) purified thrombomodulin"},{"outcome_type":"primary","measure":"Absolute thrombin generation test endogenous thrombin potential","time_frame":"Day 0","description":"Seconds; without (TM-) and with (TM+) purified thrombomodulin"},{"outcome_type":"primary","measure":"Relative thrombin generation test endogenous thrombin potential compared to reference plasma","time_frame":"Day 0","description":"%; without (TM-) and with (TM+) purified thrombomodulin"},{"outcome_type":"secondary","measure":"3-month survival rate","time_frame":"3 months","description":"Death yes/no"},{"outcome_type":"secondary","measure":"Transfer to intensive care unit during hospitalization","time_frame":"3 months","description":"Yes/no"},{"outcome_type":"secondary","measure":"Thrombotic complication during hospitalization","time_frame":"3 months","description":"Yes/no (deep vein thrombosis, pulmonary embolism, atherothrombosis flare, arterial thrombosis)"},{"outcome_type":"secondary","measure":"Plasma concentrations of D-dimers","time_frame":"Day 0","description":"µg / L, assayed by automated enzyme linked fluorescent assay (Vidas® D-dimers Exclusion ™ II)"},{"outcome_type":"secondary","measure":"Plasma concentrations of soluble fibrin monomers","time_frame":"Day 0","description":"mg / L, measured by automated immunoagglutination (STA®-Liatest® FM)"}]}
{"nct_id":"NCT04338698","start_date":"2020-04-22","phase":"Phase 3","enrollment":500,"brief_title":"Hydroxychloroquine, Oseltamivir and Azithromycin for the Treatment of COVID-19 Infection: An RCT","official_title":"Pakistan Randomized and Observational Trial to Evaluate Coronavirus Treatment","primary_completion_date":"2020-09-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2020-11-30","last_update":"2020-07-15","description":"To evaluate the effectiveness of Hydroxychloroquine Phosphate/Sulfate (200 mg orally 8hr thrice a day for 5 days) vs oseltamivir (75 mg orally twice a day for 5 days) vs Azithromycin (500 mg orally daily on day 1, followed by 250 mg orally twice a day on days 2-5) alone and in combination (in all seven groups), in clearing the coronavirus nucleic acid from throat and nasal swab and in bringing about clinical improvement on day 7 of follow-up (primary outcomes).","other_id":"12(06)/2016-Coord","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","intervention_model_description":"Adaptive design (sample size given below is indicative)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Confirmed SARS-CoV-2 (COVID-19) infection by a positive test result\r\n\r\n          2. Either gender\r\n\r\n          3. Symptomatic for example fever, dry Cough, difficulty to breathe\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Confirmed absence of SARS-CoV-2 (COVID-19) infection by a negative test result\r\n\r\n          2. Have chronic conditions such as heart disease, liver and kidney failure\r\n\r\n          3. Pregnant or currently lactating\r\n\r\n          4. Immunocompromise and/or systemic disease(s)\r\n\r\n          5. On other antiviral drugs\r\n\r\n          6. History of allergy to any of the drugs to be administered in this study\r\n      ","sponsor":"Shehnoor Azhar","sponsor_type":"Other","conditions":"COVID 19","interventions":[{"intervention_type":"Drug","name":"Drug: Hydroxychloroquine","description":"Hydroxychloroquine Phosphate/Sulfate (200 mg orally thrice a day for 5 days)"},{"intervention_type":"Drug","name":"Drug: Oseltamivir","description":"Oseltamivir (75 mg orally twice a day for 5 days)"},{"intervention_type":"Drug","name":"Drug: Azithromycin","description":"Azithromycin (500 mg orally once a day on day 1, followed by 250 mg orally daily on days 2-5)"}],"outcomes":[{"outcome_type":"primary","measure":"Laboratory Result","time_frame":"Day 07 on follow-up","description":"The laboratory-based primary outcome will be turning test negative for COVID-19 on RT-qPCR calculated as viral load of < 150 i.u"},{"outcome_type":"primary","measure":"Clinical Outcome","time_frame":"Day 07 on follow-up","description":"The clinical primary outcome will be improvement of two points on a seven-category ordinal scale shown below:\r\nNot hospitalized, able to resume normal activities\r\nNot hospitalized, but unable to resume normal activities\r\nHospitalization, not requiring supplemental oxygen\r\nHospitalization, requiring supplemental oxygen\r\nHospitalization, requiring noninvasive mechanical ventilation\r\nHospitalization, requiring invasive mechanical ventilation\r\nDeath"}]}
{"nct_id":"NCT04379388","start_date":"2020-04-21","phase":"N/A","enrollment":437,"brief_title":"Improving Smoking Cessation in Socioeconomically-Disadvantaged Young Adults","official_title":"Improving Smoking Cessation in Socioeconomically-Disadvantaged Young Adults","primary_completion_date":"2020-10-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-10-15","last_update":"2021-02-11","description":"The purpose of this study is to understand how to develop and deliver a better smoking cessation program for lower-income young adult smokers.","other_id":"17-0351","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":30,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  age 18-30\r\n\r\n          -  lives in the U.S.\r\n\r\n          -  smoked at least 100 lifetime cigarettes\r\n\r\n          -  currently smokes every day or some days\r\n\r\n          -  interest in quitting smoking within the next 6 months\r\n\r\n          -  subjective financial situation of just meeting or not meeting basic expenses\r\n\r\n          -  access to a smartphone with internet\r\n      ","sponsor":"University of Vermont","sponsor_type":"Other","conditions":"Nicotine Dependence, Cigarettes","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Web + text smoking cessation intervention","description":"Participants will receive referral to a quit smoking hotline and 12-week web and text-based smoking cessation intervention"}],"outcomes":[{"outcome_type":"secondary","measure":"7-day point prevalence smoking abstinence","time_frame":"Assessed at 3-month follow-up","description":"Self-reported smoking abstinence"},{"outcome_type":"primary","measure":"Self-efficacy to quit smoking","time_frame":"Assessed at 3-month follow-up","description":"Confidence to quit within the next month (7days) on 0-10 scale"},{"outcome_type":"primary","measure":"Intervention engagement","time_frame":"12 weeks","description":"Completing 75% or more of 12 weekly check-ins"},{"outcome_type":"primary","measure":"30-day point prevalence smoking abstinence","time_frame":"Assessed at 3-month follow-up","description":"Self-reported smoking abstinence and biochemical validation (saliva cotinine)"},{"outcome_type":"secondary","measure":"Number of 24-hour quit attempts","time_frame":"Assessed at 3-month follow-up","description":"Number of times intentionally stopped smoking cigarettes for 24 hours or longer because trying to quit"},{"outcome_type":"secondary","measure":"Perceived support to quit smoking","time_frame":"Assessed 3-month follow-up","description":"4 items pertaining to quit support from the text messages"},{"outcome_type":"secondary","measure":"Pattern and rate of tobacco/e-cigarette use","time_frame":"Assessed at 3-month follow-up","description":"Past 30 (90 day) use of tobacco or nicotine products such as cigars, e-cigarettes, chewing tobacco, and nicotine replacement products"}]}
{"nct_id":"NCT04742023","start_date":"2020-04-21","phase":"Early Phase 1","enrollment":40,"brief_title":"Post-operative Complications and Graft Survival With Conventional Versus Continuous Glucose Monitoring in Patients With Diabetes Mellitus Undergoing Renal Transplantation","official_title":"Post-operative Complications and Graft Survival With Conventional Versus Continuous Glucose Monitoring in Patients With Diabetes Mellitus Undergoing Renal Transplantation","primary_completion_date":"2021-11-21","study_type":"Interventional","rec_status":"Enrolling by invitation","completion_date":"2021-12-21","last_update":"2021-07-09","description":"This will be a prospective, randomized, single-blinded controlled trial in which the investigators evaluate post-operative serum glucose control using conventional point-of-care glucose monitoring in the morning and before meals (standard of care) versus continuous glucose monitoring using the Medtronic Guardian Sensor 3 continuous glucose monitor. The investigators will compare the average daily glucose level in the post-operative period (through post-operative day five) between the two arms in patients with diabetic nephropathy immediately post-renal transplant. This will serve as a pilot study to in order to power a main study.","other_id":"20-0066","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Provision of signed and dated informed consent form\r\n\r\n          2. Stated willingness to comply with all study procedures and availability for the\r\n             duration of the study\r\n\r\n          3. Male or female, aged 18 years or older\r\n\r\n          4. Undergoing first-time renal transplantation\r\n\r\n          5. Have a pre-existing diagnosis of Type 2 diabetes mellitus\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Age less than 18 years\r\n\r\n          2. History of prior renal transplant\r\n\r\n          3. Use of continuous glucose monitoring or insulin pump at time of transplant\r\n\r\n          4. Insulin infusion requirement during hospitalization\r\n\r\n          5. Pregnancy or lactation\r\n\r\n          6. Known allergic reaction to Guardian Sensor 3 or adhesives\r\n\r\n          7. Use of peritoneal dialysis\r\n\r\n          8. Diagnosis of Type 1 diabetes mellitus\r\n\r\n          9. History of hypoglycemia unawareness\r\n      ","sponsor":"Northwell Health","sponsor_type":"Other","conditions":"Diabetes Mellitus","interventions":[{"intervention_type":"Device","name":"Device: Continuous Glucose Monitor Application","description":"The Guardian Sensor glucose sensor is part of the Medtronic Continuous Glucose Monitoring (CGM) system. The system then uses these signals to provide sensor glucose values. Patients post-renal transplantation will have CGMs applied and values interpreted by nursing."},{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Finger Stick Glucose Measurement","description":"Patients post-renal transplant will have finger-stick glucose measurements checked prior to meals."},{"intervention_type":"Drug","name":"Drug: Insulin","description":"Insulin will be administered."},{"intervention_type":"Device","name":"Device: Continuous Glucose Monitor Placebo Applied","description":"The Guardian Sensor glucose sensor is part of the Medtronic Continuous Glucose Monitoring (CGM) system. The system then uses these signals to provide sensor glucose values. Patients post-renal transplantation will have CGMs applied however values will not be interpreted."}],"outcomes":[{"outcome_type":"primary","measure":"Average Daily Glucose","time_frame":"Postoperative day 1 - 5","description":"The primary outcome of this study is average daily glucose level."},{"outcome_type":"secondary","measure":"Number of Hyperglycemic Episodes","time_frame":"Postoperative days 1-5","description":"The number of episodes where glucose goes from <180mg/dl to ≥ 180 mg/dl."},{"outcome_type":"secondary","measure":"Number of Hypoglycemic Episodes","time_frame":"Postoperative days 1-5","description":"The number of episodes where glucose levels go from > 80 mg/dl to ≤ 80 mg/dl"},{"outcome_type":"secondary","measure":"Total Insulin Use","time_frame":"Postoperative days 1-5","description":"The total number of insulin units used"}]}
{"nct_id":"NCT04321174","start_date":"2020-04-17","phase":"Phase 3","enrollment":1220,"brief_title":"COVID-19 Ring-based Prevention Trial With Lopinavir/Ritonavir","official_title":"COVID-19 Ring-based Prevention Trial With Lopinavir/Ritonavir","primary_completion_date":"2021-03-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-03-31","last_update":"2020-04-21","description":"COVID-19 has rapidly evolved into a generalized global pandemic. Post-exposure prophylaxis (PEP) against on COVID-19 was identified as an urgent research priority by the WHO, and lopinavir/ritonavir (LPV/r) is a promising candidate for both COVID-19 treatment and PEP, with a good safety profile and global availability. This is a cluster randomized controlled trial (RCT) of oral LPV/r as PEP against COVID-19, that will address the immediate need for preventive interventions, generate key data on COVID-19 transmission, and serve as a research platform for future vaccines and preventive agents.","other_id":"CORIPREV-1","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":1.5,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. High risk close contact with a confirmed COVID-19 case during their symptomatic\r\n             period, including one day before symptom onset, within the past 1-7 days. High risk\r\n             close contact is defined as any of the following exposures without the consistent\r\n             appropriate use of recommended personal protective equipment:\r\n\r\n               1. Provided direct care for the index case\r\n\r\n               2. Had close physical contact with the index case\r\n\r\n               3. Lived with the index case\r\n\r\n               4. Had close contact (within 2 metres), without direct physical contact, for a\r\n                  prolonged period of time\r\n\r\n               5. Had direct contact with infectious body fluids, including oral secretions,\r\n                  respiratory secretions, or stool.\r\n\r\n          2. Successfully contacted by the study team within 24 hours of study team notification of\r\n             the relevant index COVID-19 case. This time window is necessary because the efficacy\r\n             of PEP may be dependent on the timing of its initiation, and because randomization of\r\n             a ring cannot be delayed while awaiting response from contacts that cannot be rapidly\r\n             reached.\r\n\r\n          3. Age 6 months, since the safety and pharmacokinetic profiles of LPV/r in pediatric\r\n             patients below the age of 6 months have not been established.\r\n\r\n          4. Ability to communicate with study staff in English\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Known hypersensitivity/allergy to lopinavir or ritonavir.\r\n\r\n          2. Current use of LPV/r for the treatment or prevention of HIV infection.\r\n\r\n          3. Receipt of LPV/r in the context of this trial or any other trial of COVID-19 PEP\r\n             within 2 days or less prior to the last known contact with the index COVID-19 case.\r\n             The two day time window is intended to ensure that exposure would not have occurred in\r\n             the presence of clinically relevant drug levels (five times the elimination half-life\r\n             of LPV/r, which is estimated at 4-6 hours with prolonged use).\r\n\r\n          4. Baseline respiratory tract specimen positive for COVID-19. Randomized participants\r\n             whose baseline samples subsequently show COVID-19 will have study drug discontinued\r\n             but still remain under observation.\r\n\r\n          5. Current breastfeeding, due to potential for serious adverse reactions in nursing\r\n             infants exposed to LPV/r\r\n\r\n          6. Concomitant medications with prohibited drug interactions with LPV/r that cannot be\r\n             temporarily suspended/replaced, including but not restricted to: 37\r\n\r\n               -  alfuzosin (e.g. Xatral)\r\n\r\n               -  amiodarone (e.g. Cordarone)\r\n\r\n               -  apalutamide (e.g. Erleada)\r\n\r\n               -  astemizole*, terfenadine*\r\n\r\n               -  cisapride*\r\n\r\n               -  colchicine, when used in patients with renal and/or hepatic impairment\r\n\r\n               -  dronedarone (e.g., Multaq)\r\n\r\n               -  elbasvir/grazoprevir (e.g., ZepatierTM)\r\n\r\n               -  ergotamine* (e.g. Cafergot*), dihydroergotamine (e.g. Migranal), ergonovine,\r\n                  methylergonovine*\r\n\r\n               -  fusidic acid (e.g., Fucidin), systemic*\r\n\r\n               -  lurasidone (e.g., Latuda), pimozide (e.g., Orap*)\r\n\r\n               -  neratinib (e.g., Nerlynx)\r\n\r\n               -  sildenafil (e.g., Revatio)\r\n\r\n               -  triazolam (e.g. Halcion), midazolam oral*\r\n\r\n               -  rifampin (e.g. Rimactane*, Rifadin, Rifater*, Rifamate*)\r\n\r\n               -  St. John's Wort\r\n\r\n               -  Tadalafil (e.g. Adcirca)\r\n\r\n               -  venetoclax (e.g. Venclexta)\r\n\r\n               -  lovastatin (e.g., Mevacor*), lomitapide (e.g., JuxtapidTM) or simvastatin (e.g.,\r\n                  Zocor)\r\n\r\n               -  vardenafil (e.g., Levitra or Staxyn)\r\n\r\n               -  salmeterol (e.g., Advair or Serevent)\r\n\r\n                    -  denotes products not marketed in Canada\r\n      ","sponsor":"Darrell Tan","sponsor_type":"Other","conditions":"Coronavirus Infections|Post-exposure Prophylaxis","interventions":[{"intervention_type":"Drug","name":"Drug: Lopinavir/ritonavir","description":"The intervention is a 14-day course of LPV/r 400/100 mg orally twice daily, or equivalent weight-based dosing, to be initiated as soon as possible (within 1-7 days) after the last exposure."}],"outcomes":[{"outcome_type":"secondary","measure":"Seropositivity","time_frame":"28 days","description":"Reactive serology to SARS-CoV-2"},{"outcome_type":"secondary","measure":"Days of hospitalization attributable to COVID-19 disease","time_frame":"90 days","description":"The number of days (or partial days) spent admitted to an acute care hospital will be tabulated both at day 28 and day 90"},{"outcome_type":"secondary","measure":"Respiratory failure requiring ventilatory support attributable to COVID-19 disease","time_frame":"90 days","description":"The number of days (or partial days) requiring i) non-invasive and ii) endotracheal intubation with ventilation will be tabulated both at day 28 and day 90."},{"outcome_type":"primary","measure":"Microbiologic evidence of infection","time_frame":"14 days","description":"The primary outcome is microbiologically confirmed COVID-19 infection, ie. detection of viral RNA in a respiratory specimen (mid-turbinate swab, nasopharyngeal swab, sputum specimen, saliva specimen, oral swab, endotracheal aspirate, bronchoalveolar lavage specimen) by day 14 of the study."},{"outcome_type":"secondary","measure":"Adverse events","time_frame":"90 days","description":"a) Adverse events: as defined using the DAIDS Table for Grading the Severity of Adverse Events, at 7, 14, 28 & 90 days"},{"outcome_type":"secondary","measure":"Symptomatic COVID-19 disease","time_frame":"14 days","description":"fever, cough or other respiratory/ systemic symptoms (including but not limited to fatigue, myalgias, arthralgias, shortness of breath, sore throat, headache, chills, coryza, nausea, vomiting, diarrhea) by day 14 in a patient with laboratory confirmed infection, combined with microbiologic confirmation of COVID-19 infection in the participant."},{"outcome_type":"secondary","measure":"Mortality","time_frame":"90 days","description":"Death attributable to COVID-19 disease and all-cause mortality"},{"outcome_type":"secondary","measure":"Short-term psychological impact of exposure to COVID-19 disease","time_frame":"28 days","description":"Short-term psychological distress will be measured using the K10, with a standard cutoff score of ≥16."},{"outcome_type":"secondary","measure":"Long-term psychological impact of exposure to COVID-19 disease","time_frame":"90 days","description":"Long-term impact will be measured at day 90 using the Impact of Event Scale, a validated measure of traumatic stress response, using a standard cutoff score of ≥26"},{"outcome_type":"secondary","measure":"Health-related quality of life","time_frame":"90 days","description":"Health-related quality of life will be measured using the EQ-5D-5L (EuroQol-5D). The EQ-5D consists of two pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The tool will be administered to participants at 1, 14, 28 and 90 days."}]}
{"nct_id":"NCT04475120","start_date":"2020-04-15","phase":"Phase 2/Phase 3","enrollment":92,"brief_title":"Efficacy and Safety of Liposomal Lactoferrin in COVID-19 Patients With Mild-to-Moderate Disease and in COVID-19 Asymptomatic Patients","official_title":"Interventional Pilot Study to Assess the Use of Oral and Intra-nasal Liposomal Lactoferrin in COVID-19 Patients With Mild-to-Moderate Disease and in COVID-19 Asymptomatic Patients","primary_completion_date":"2020-07-02","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-07-02","last_update":"2021-05-14","description":"COVID-19 is considered an ongoing international global health problem which already caused 12 million confirmed cases. No specific effective treatment has been identified so far, and available supportive therapies are intended just to severe patients. Asymptomatic and mildly symptomatic patients remain a transmission reservoir, with possible evolution to the most severe disease form, without a clear treatment indication. Lactoferrin (Lf) is a multifunctional glycoprotein, belonging to transferrin family, secreted by exocrine glands and neutrophils and present in all human secretion. The pleiotropic activity of Lf is mainly based on its four different functions: chelate two ferric iron per molecule, interact with anionic molecules, enter inside nucleus and modulate iron homeostasis. The ability to chelate two ferric ions per molecule is associated to the inhibition of reactive oxygen species formation as well as this sequestration of iron, pivotal for bacterial and viral replication, is at the basis of its antibacterial and antiviral activity. Moreover, Lf exerts its antiviral activity against the majority of the tested viruses by binding to heparan sulphate, while against few viruses by interacting with surface components of viral particles. The capability of Lf to exert antiviral activity, by binding to host cells or viral particles or both, strengthens the idea that this glycoprotein is \"an important brick in the mucosal wall, effective against viral attacks\". Lf was able to block the binding of the spike protein to host cells, indicating that Lf exerted its inhibitory function at the viral attachment stage. The current accepted model suggests that Lf could block viral entry by interacting with heparan sulfate proteoglycans (HSPGs), which mediate the transport of extracellular virus particles from the low affinity anchoring sites to the high affinity specific entry as ACE-2. Investigators performed a prospective, interventional pilot study to assess the efficacy of liposomal lactoferrin in COVID-19 patients with mild-to moderate disease and in COVID-19 asymptomatic patients. Secondary objectives evaluated the safety and tolerability of liposomal lactoferrin for oral and intra-nasal use.","other_id":"4220","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Eligible patients were over 20years old, with a confirmed positivity to COVID-19 at the\r\n        oropharyngeal swab\r\n\r\n        Exclusion Criteria:\r\n\r\n        pregnant and lactating women, patients taking nitric oxide and nitrates, patients with\r\n        reported allergy to milk proteins, patients with a previous history of bronchial\r\n        hyperactivity and patients with pre-existing respiratory diseases. COVID-19 patients\r\n        requiring intensive care or mechanical ventilation were excluded.\r\n      ","sponsor":"University of Rome Tor Vergata","sponsor_type":"Other","conditions":"Covid19","interventions":[{"intervention_type":"Drug","name":"Drug: liposomal lactoferrin","description":"oral and intra-nasal formulation"},{"intervention_type":"Drug","name":"Drug: SOC therapy","description":"oral administration"}],"outcomes":[{"outcome_type":"primary","measure":"Rate of viral clearance Time to viral clearance","time_frame":"30 days","description":"time to naso-oro-pharingeal swab negativization"},{"outcome_type":"secondary","measure":"Time to clinical improvement","time_frame":"30 days","description":"time to improvement of clinical symptoms and blood parameters"}]}
{"nct_id":"NCT04320134","start_date":"2020-04-15","enrollment":5000,"brief_title":"cliNIcal sCEnarios and Pathophysiology of Atrial Fibrillation","official_title":"CliNIcal SCEnarios and Pathophysiological Features of Patients With Atrial Fibrillation: a Long Term Prospective Study (NICE-AF Study)","primary_completion_date":"2022-04-15","study_type":"Observational [Patient Registry]","rec_status":"Not yet recruiting","completion_date":"2025-04-15","last_update":"2020-03-24","description":"Atrial fibrillation (AF) remains the most common sustained cardiac arrhythmia with prevalence and incidence continuously increasing worldwide. Current guidelines propose an etiological, symptom-based classification of the arrhythmia and mainly focused on its duration with consequent rhythm or rate-control strategies. Moreover, risk scores for atherothrombotic systemic or hemorrhagic events related to atrial fibrillation are principally based on patients cardiovascular history and risk factors. This approach do not consider relevant pathophysiological aspects that may play a pivotal role in triggering or perpetuating the arrhythmia, especially at its first occurrence. At this point, a crucial step would be deeply investigating AF clinical and pathophysiological features to guide a tailored diagnostical and therapeutic approach. Indeed, early recognition and proper characterization of triggers, substrates, autonomic system imbalance and modulating factors (drugs, electrolytes, etc) are of the utmost importance for AF care and management. Therefore, this large scale prospective observational study aims to evaluate clinical and pathophysiological features of patients with symptomatic and asymptomatic atrial fibrillation in different scenarios to understand possible distinctive characteristics warranting a personalized approach to the arrhythmia.","other_id":"PoliclinicoCasilino1-2020","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"In this prospective observational study we consider to enroll patients with diagnosis of\r\n        Atrial Fibrillation (new onset, paroxysmal, persistent, long-persistent and permanent)\r\n        admitted to our Hospital in the Emergency Room and/or Cardiology Department/Ambulatory Care\r\n        Center.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with electrocardiographic diagnosis of Atrial Fibrillation (New Onset,\r\n             Paroxysmal, Persistent, Long Standing Persistent and Permanent) admitted to the\r\n             Emergency Room and/or Cardiology Department /ambulatory care center of our Hospital\r\n\r\n          -  Age >18 years old\r\n\r\n          -  Patients who can give their written informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Age <18 years old\r\n\r\n          -  Patients who cannot give their written informed consent.\r\n      ","sponsor":"Policlinico Casilino ASL RMB","sponsor_type":"Other","conditions":"Atrial Fibrillation","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Rate of Atrial Fibrillation recurrences","time_frame":"5 years","description":"frequency distribution"},{"outcome_type":"secondary","measure":"Concentration of laboratory biomarkers","time_frame":"baseline and 5 years","description":"Complete Blood cell count with differential; Interleukin-1, Interleukin-6, High sensitivity C Reactive protein"},{"outcome_type":"primary","measure":"Number of participants with Major Adverse Cardiac Events (MACE)","time_frame":"5 years","description":"frequency distribution"},{"outcome_type":"primary","measure":"Rate of thromboembolic events","time_frame":"5 years","description":"frequency distribution"},{"outcome_type":"primary","measure":"Rate of bleeding events","time_frame":"5 years","description":"frequency distribution of minor, major and fatal bleedings"},{"outcome_type":"secondary","measure":"Rate of participants socio-demographic characteristics","time_frame":"baseline and 5 years","description":"Frequency distribution: age, gender, race, occupation, life-style, diet, physical activity, alcohol consumption"},{"outcome_type":"secondary","measure":"Rate of participants with comorbidities","time_frame":"baseline and 5 years","description":"Frequency distribution: hypertension, heart failure, diabetes mellitus, kidney failure, dyslipidemia, lung diseases, thyroid disorders, gastrointestinal and liver disorders, hematological diseases, neoplasms, autoimmune disorders"},{"outcome_type":"secondary","measure":"Rate of participants with Heart diseases","time_frame":"baseline and 5 years","description":"frequency distribution: vascular diseases, valvular problems, cardiomyopathies, arrhythmias, family/genetic history of cardiovascular disease"},{"outcome_type":"secondary","measure":"Rate of patients with Atrial Fibrillation secondary to triggers and/or autonomic system imbalance and/or modifiable factors","time_frame":"baseline and 5 years","description":"Frequency distribution of patients in which atrial fibrillation was clearly related to adrenergic tone imbalance and/or vagal tone imbalance and/or secondary to modifiable factors"},{"outcome_type":"secondary","measure":"Describe imaging parameters (echocardiogram and cardiac magnetic resonance)","time_frame":"baseline and 5 years","description":"Left ventricle, right ventricle, right and left atrium and valves: morphologies, volumes, dimensions and function"}]}
{"nct_id":"NCT04340960","start_date":"2020-04-01","phase":"Phase 2/Phase 3","enrollment":80,"brief_title":"Home Monitoring for Thoracic Surgery Patients","official_title":"Effect of Continuity of Care With Digital Home Monitoring on Postoperative Outcomes in Patients Undergoing Thoracic Surgery: A Randomized Controlled Trial (CDHM: RCT)","primary_completion_date":"2022-04-01","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2022-06-02","last_update":"2020-04-10","description":"Background and Importance: When patients transition from hospital to home following surgery, perceived complications or poorly controlled pain can result in emergency department visits and readmissions. Continuity of care after discharge has been shown to reduce ED visits and readmissions rates. Hence any improved method of extending the continuity of care into a patient's home may improve postoperative outcomes. For patients who are at risk, continuity of care with digital solutions offers a pathway to providing more education, influencing behavior, and creating better outcomes. Care teams can understand what's going on with each patient daily or weekly, as opposed to sporadically through an office visit. Goals/Research Aims: Atrial fibrillation is one of the important complications after thoracic surgery, it is estimated to occur in 10.5% of patients. We will conduct a randomized controlled trial to test use of a secured digital system to monitor vital signs and home-based ECG monitoring for 2 weeks after surgery in patients undergoing elective thoracic surgical procedure at the London Health Sciences Centre [LHSC]. Specific objectives are to determine 30-day emergency department visits as the primary outcome, and 30-day readmission rates, postoperative complications, in-hospital length of stay, pain scores, hospital case costing, societal costs, mortality, and patient satisfaction. Methods/Approaches/Expertise: This trial will be a single centre, assessor blinded, parallel arm, randomised controlled trial. Participants will be recruited from patients scheduled for thoracic surgical procedures at LHSC. Patients will be randomized to either the Continuity of care with Digital Home Monitoring (CDHM) group or control group. The control group will be provided the usual post-operative care, and the CDHM group will be provided with access to self-help resources, digital monitoring and access to a clinical navigator for two weeks. All outcomes will be compared between the CDHM group and control group at the end of 4 weeks post-discharge, including out of pocket costs, travel costs and lost productivity. Expected Outcomes: The Ontario Hospital Association estimates the average cost of a one-day stay in an acute care hospital is $1,300. With digital monitoring and continuity of care, we expect to decrease visits and readmission rates by at least 50% and in-hospital length stay by at least one day.","other_id":"CDHM:RCT","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patient willing to provide informed consent\r\n\r\n          -  Availability of a caregiver at the patient's home\r\n\r\n          -  Wi-fi or cellular connectivity at the patient's home\r\n\r\n          -  Undergoing elective segmentectomy, lobectomy, or pneumonectomy; VATS or open procedure\r\n\r\n          -  ASA III or lower\r\n\r\n          -  Ability to comprehend and consent in English\r\n\r\n          -  Patient or caregiver familiar/comfortable with the use of the technology like online\r\n             banking\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Unstable disease process preoperatively\r\n\r\n          -  Patient requiring postoperative ICU admission\r\n\r\n          -  Expected unstable disease process in the postoperative period\r\n      ","sponsor":"Western University, Canada","sponsor_type":"Other","conditions":"Atrial Fibrillation","interventions":[{"intervention_type":"Other","name":"Other: Home Monitoring","description":"Patients in this group will receive home monitoring for NIBP (non-invasive blood pressure), SPO2 (pulse oximetry), ECG (electrocardiogram), and pain scores. These will be monitored 4 times a day for 2 weeks following surgery."}],"outcomes":[{"outcome_type":"primary","measure":"Amount of missing clinical data","time_frame":"1 year","description":"As collected on the Case Report Forms and loss-to-follow-up"},{"outcome_type":"primary","measure":"Recruitment rate","time_frame":"1 year","description":"Number of patients recruited over the period of the study, a measure of study feasibility"},{"outcome_type":"secondary","measure":"Patient satisfaction score","time_frame":"30 days postoperatively","description":"Using 5 point Likert's satisfaction scale: a 5-point Likert scale, 1 - strongly disagree, 2 - disagree, 3 - neutral, 4 - agree and 5 - strongly agree,"},{"outcome_type":"secondary","measure":"Patient/caregiver experience","time_frame":"30 days postoperatively","description":"Using a caregiver questionnaire"},{"outcome_type":"secondary","measure":"30 day readmission rate","time_frame":"30 days postoperatively","description":"Thirty day hospital readmission rate"}]}
{"nct_id":"NCT04304092","start_date":"2020-04-01","phase":"N/A","enrollment":300,"brief_title":"Addressing Individual Variability in Response to Exercise","official_title":"Addressing Individual Variability in Response to Exercise","primary_completion_date":"2024-04-01","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2024-04-01","last_update":"2020-03-11","description":"In this proposal, the investigators challenge the assumption that following the physical activity guidelines implies benefit for ALL adults, and that if benefit is not achieved in response to first line therapy, it will be by simply exercising more. Thus, for improving cardiorespiratory fitness and cardiometabolic risk factors, unanswered questions include: 1) To what extent, regardless of exercise amount or intensity, is exercise not associated with benefit? Demonstration of a resistance to benefit through exercise in a substantial number of adults would be a novel and important finding, would counter the assumptions of many if not most health care practitioners, and could have immediate and direct application in all health care settings. 2) To what extent will non-responders to first line therapy (150 min/wk) be required to increase exercise amount or intensity to achieve benefit? 3) To what extent will failure to improve CRF segregate (be associate with) with cardiometabolic risk factors? The investigators propose that adults who remain exercise resistant for improvement in CRF and cardiometabolic risk despite increasing amount or intensity are at high risk of metabolic disease and consequently, are candidates for alternative treatment strategies. 4) To what extent is biological sex and/or phenotype a determinant of response or non-response to exercise?","other_id":"Ross2019","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":25,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Sedentary lifestyle (planned physical activity for one day per week or less).\r\n\r\n          -  Weight stable ( 2 kg) for 6 months prior to the beginning of the study.\r\n\r\n          -  BMI between 20 and 40 kg/m2.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Physical impairment which would make the intervention very difficult or unsafe\r\n             according to doctor's advice.\r\n\r\n          -  Diabetes, current smokers.\r\n\r\n          -  Plan to move from the area in next 8 months.\r\n      ","sponsor":"Dr. Bob Ross","sponsor_type":"Other","conditions":"Exercise|Cardiorespiratory Fitness","interventions":[{"intervention_type":"Other","name":"Other: Exercise","description":"Participants will exercise under supervision. Exercise dose will vary by amount and intensity"}],"outcomes":[{"outcome_type":"secondary","measure":"Change in cardiometabolic risk factor","time_frame":"Measured at baseline, 16 and 32 weeks.","description":"fasting triglycerides (mmol/L)"},{"outcome_type":"primary","measure":"Change in Cardiorespiratory Fitness","time_frame":"Measured at baseline and every 4 weeks for 32 weeks.","description":"Cardiorespiratory fitness will be determined using direct (open circuit spirometry) measures of oxygen consumption (expressed in L/min) obtained during a maximal treadmill test."},{"outcome_type":"secondary","measure":"Change in cardiometabolic risk factors","time_frame":"Measured at baseline, 16 and 32 weeks.","description":"Fasting glucose (mmol/L)"},{"outcome_type":"secondary","measure":"Change in cardiometabolic risk factors","time_frame":"Measured at baseline, 16 and 32 weeks.","description":"Fasting LDL- and HDL-cholesterol (mmol/L)"},{"outcome_type":"secondary","measure":"Change in cardiometabolic risk factors","time_frame":"Measured at baseline, 16 and 32 weeks.","description":"fasting insulin (pmol/L)"}]}
{"nct_id":"NCT04298229","start_date":"2020-04-01","phase":"Phase 3","enrollment":240,"brief_title":"Efficacy and Safety of Dapagliflozin in Acute Heart Failure","official_title":"A Randomized, Open-label Study of Dapagliflozin in Patients With Type 2 Diabetes Admitted With Acute Heart Failure","primary_completion_date":"2022-02-28","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-03-31","last_update":"2021-06-04","description":"This is a randomized trial of the addition of dapagliflozin to patients with diabetes hospitalized with acute decompensated heart failure (ADHF). Participants will be recruited following an initial standard evaluation in the ED and randomized within 24 hours of presentation for ADHF in a 1:1 fashion to protocolized diuretic therapy or dapagliflozin + protocolized diuretic therapy.","other_id":"200017","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","intervention_model_description":"Participants will be recruited following an initial standard evaluation in the ED and randomized within 24 hours of presentation for ADHF in a 1:1 fashion to protocolized diuretic therapy or dapagliflozin + protocolized diuretic therapy.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age of 18 years or older\r\n\r\n          -  Randomized within 24 of presentation during a hospital admission for hypervolemic\r\n             decompensated heart failure defined as:\r\n\r\n               -  pulmonary artery catheterization with a pulmonary capillary wedge pressure\r\n                  greater than 19mmHg plus a systemic physical exam finding of hypervolemia\r\n                  (peripheral edema, ascites, or pulmonary edema on auscultation)\r\n\r\n               -  in the absence of pulmonary artery catheterization data 2 of the following signs\r\n                  or symptoms: peripheral edema, ascites, jugular venous pressure > 10mmHg,\r\n                  orthopnea, paroxysmal nocturnal dyspnea, 5-pound weight gain, or signs of\r\n                  congestion on chest x-ray or lung ultrasound\r\n\r\n          -  Planned use of IV loop diuretic therapy during current hospitalization\r\n\r\n          -  eGFR > 30 ml/min/1.73m2 by the MDRD equation\r\n\r\n          -  History of type 2 diabetes or a new hemoglobin A1c > 6.5% this admission\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Type 1 diabetes\r\n\r\n          -  Serum glucose < 80mg/dl at enrollment\r\n\r\n          -  Systolic blood pressure < 90mmHg at enrollment\r\n\r\n          -  Requirement of intravenous inotropic therapy\r\n\r\n          -  History of hypersensitivity to any SGLT2 inhibitors\r\n\r\n          -  Women who are pregnant or breastfeeding\r\n\r\n          -  Severe anemia (Hemoglobin < 7.5g/dl)\r\n\r\n          -  Severe uncorrected aortic or mitral stenosis\r\n\r\n          -  Inability to perform standing weights or measure urine output accurately\r\n\r\n          -  History of diabetic ketoacidosis\r\n\r\n          -  Scheduled combination nephron blockade with loop and thiazide therapy as an outpatient\r\n\r\n          -  Diffuse anasarca with 4+ edema and projected hypervolemia exceeding 40-pounds\r\n\r\n          -  Severe hepatic impairment (Child-Pugh class C)\r\n      ","sponsor":"Vanderbilt University Medical Center","sponsor_type":"Other","conditions":"Heart Failure|Diabetes Mellitus, Type 2","interventions":[{"intervention_type":"Drug","name":"Drug: Dapagliflozin 10 MG","description":"SGLT2 inhibitors being investigated for its diuretic and natriuretic effects on top of protocolized diuretic therapy."},{"intervention_type":"Other","name":"Other: Protocolized Diuretic Therapy","description":"Structured usual care arm with protocolized diuretic therapy based on urine output."}],"outcomes":[{"outcome_type":"primary","measure":"Cumulative change in weight (kilograms)","time_frame":"Baseline to Day 5 or discharge if earlier","description":"cumulative change in weight (kilograms) per 40mg of IV furosemide equivalents from enrollment to day 5 or discharge (if earlier) between protocolized diuretic therapy and dapagliflozin plus protocolized diuretic therapy guided by urine output"},{"outcome_type":"secondary","measure":"Incidence of worsening heart failure","time_frame":"Baseline to hospital discharge, an average of 5 days","description":"Incidence of worsening heart failure during hospitalization requiring IV inotropic therapy with dobutamine, milrinone, or dopamine or admission to an intensive care unit as adjudicated by the Clinical Event Adjudication Committee"},{"outcome_type":"secondary","measure":"Hospital readmission","time_frame":"Day 30","description":"Hospital readmission within 30 days of discharge for heart failure or diabetic reasons as adjudicated by the Clinical Event Adjudication Committee"}]}
{"nct_id":"NCT04945811","start_date":"2020-04-01","phase":"N/A","enrollment":100,"brief_title":"Role of Interleukin-6 and Procalcitonin as Novel Inflammatory Biomarkers in Evaluating COVID 19 Disease Severity - an Experience at CMH Quetta","official_title":"Role of Interleukin-6 and Procalcitonin in Evaluating COVID 19 Disease Severity - an Experience at CMH Quetta","primary_completion_date":"2021-05-15","study_type":"Interventional","rec_status":"Completed","completion_date":"2021-05-30","last_update":"2021-06-30","description":"Serum Interleukin-6 and Procalcitonin of 100 consenting COVID 19 positive patients from April 2020 - May 2021 were assessed at Pathology department CMH Quetta and the results were correlated with severity of lung involvement on HRCT Chest","other_id":"CMHQ3","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":38,"maximum_age":71,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  positive PCR of COVID 19\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  NEGATIVE PCR of COVID 19\r\n      ","sponsor":"FARAH AFZAL","sponsor_type":"Other","conditions":"Covid19 Positive Patients","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Interlukein 6 and procalcitonin serum levels","description":"Blood tests"}],"outcomes":[{"outcome_type":"primary","measure":"Levels of inflammatory biomarkers is raised in accordance with severity of COVID 19","time_frame":"2 days","description":"serum Interlukin-6 levels was measured on COBAS-e 411 Immunoassay analyzer using electro chemiluminescence methodology using Roche Interlukin-6 kit with raised levels taken as > 7 pico gram / milliliter (pg/ml). Serum procalcitonin were also measured by similar methodology using Roche procalcitonin kit with raised levels taken as > 0.15 nano gram / milliliter (ng/ml).\r\nCOVID 19 pneumonia was categorized on HRCT chest as Mild with total score 7 or less, moderate with score from 8 - 17, and severe with score more than 18."}]}
{"nct_id":"NCT04279678","start_date":"2020-03-31","enrollment":50,"brief_title":"Surgical Strategies in Moderate Ischemic Mitral Insufficiency in Patients Undergoing Coronary Artery Bypass Graft","official_title":"Surgical Strategies in Moderate Ischemic Mitral Insufficiency in Patients Undergoing Coronary Artery Bypass Graft","primary_completion_date":"2023-11-30","study_type":"Observational","rec_status":"Not yet recruiting","completion_date":"2023-12-31","last_update":"2020-02-24","description":"Ischemic mitral regurgitation (IMR) is a common complication of myocardial infarction, with a reported prevalence of 13-59%. Approximately one-third of these patients have at least moderate MR .","other_id":"Moderate ischemic MR","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","population":"study will be conducted on all patients diagnosed as ischemic heart disease with\r\n        multi-vessel disease indicated for CABG with moderate degree of ischemic mitral\r\n        regurgitation and meeting inclusion and exclusion criteria at duration between 2019 and\r\n        2021 at cardiothoracic surgery department in Assuit university hospital","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  All patient with multi-vessel coronary artery disease with moderate degree of ischemic\r\n             mitral regurgitation .\r\n\r\n          -  Patient undergone surgery using cardiopulmonary bypass.\r\n\r\n          -  Patient done on elective basis\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  CABG done by off-pump technique.\r\n\r\n          -  patients not candidates for complete revascularization.\r\n\r\n          -  patients with other valvular affection other than mitral valve.\r\n\r\n          -  Patients done on emergency basis.\r\n\r\n          -  patient known to have Rheumatic valvular heart disease.\r\n      ","sponsor":"Assiut University","sponsor_type":"Other","conditions":"Moderate Ischemic Mitral Regurgitation","interventions":[{"intervention_type":"Procedure","name":"Procedure: Mitral valve repair","description":"surgical repair of moderate ischemic mitral regurgitation using pericardial patch or rigid semi-annular ring"}],"outcomes":[{"outcome_type":"primary","measure":"To compare the outcome of mitral valve repair plus CABG vs CABG alone.","time_frame":"post operative ECHO assessment after 6 months.","description":"the aim is to determine whether there is significant difference postoperatively in patients undergoing mitral valve repair+CABG and those with CABG only regarding post operative degree of MR."}]}
{"nct_id":"NCT03729310","start_date":"2020-03-31","phase":"Early Phase 1","enrollment":0,"brief_title":"Comparison of Two Steroid Nasal Implants Following Endoscopic Sinus Surgery for Chronic Rhinosinusitis","official_title":"Comparison of Two Steroid Nasal Implants Following Endoscopic Sinus Surgery for Chronic Rhinosinusitis","primary_completion_date":"2020-05-26","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2020-05-26","last_update":"2020-05-28","description":"The purpose of this study is to learn whether there is a difference in postoperative (after surgery) endoscopic appearance of the sinus cavities (the way that the sinuses look through a camera) between sinuses that receive one of two types of resorbable steroid eluting sinus packing (a sponge-like material which dissolves within several days while releasing a steroid): 1) Propel Implant or 2) Nasopore soaked with triamcinolone at the time of endoscopic sinus surgery (ESS) for chronic rhinosinusitis.","other_id":"1802018943","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","intervention_model_description":"Each subject will have both treatments (Propel and Nasopore), with one treatment on one side and the other treatment on the opposite side. The treatment for the right and left cavity will be selected in a randomized fashion (using opaque envelopes to assign each treatment to a respective ethmoid cavity).","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":100,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        -Adult patients undergoing endoscopic sinus surgery for the treatment of chronic\r\n        rhinosinusitis refractory to medical management\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients ineligible for informed consent\r\n\r\n          -  Patients unwilling or unable to comply with the postoperative visits necessary for\r\n             data collection\r\n\r\n          -  Patients with a history of intolerance to triamcinolone\r\n\r\n          -  Patients with suspected systemic inflammatory disease, cystic fibrosis, and any\r\n             contraindication to systemic corticosteroids.\r\n\r\n          -  As standard of care, the PI does not operate on pregnant patients. A pregnant patient\r\n             would not be a candidate for the study.\r\n      ","sponsor":"Weill Medical College of Cornell University","sponsor_type":"Other","conditions":"Chronic Sinusitis|Rhinosinusitis","interventions":[{"intervention_type":"Device","name":"Device: Propel 'implant'","description":"The Propel 'implant' is composed of small, flexible tubes which dissolve while releasing Mometasone which is one type of steroid. This application has been approved for use by the FDA."},{"intervention_type":"Drug","name":"Drug: Triamcinolone","description":"Triamcinolone has been approved for use topically elsewhere on the body, although the specific use of Triamcinolone in the sinuses has not been approved by the FDA."},{"intervention_type":"Device","name":"Device: Nasopore","description":"This \"packing' is a sponge-like material which dissolves while releasing triamcinolone."}],"outcomes":[{"outcome_type":"primary","measure":"Change from Pre-operative score in Patient's nasal endoscopy, as measured by Perioperative Sinus Endoscopy (POSE) Scores","time_frame":"Pre-operatively; Post-operatively at 1 week, 3 weeks, 6 weeks, 12 weeks.","description":"Validated endoscopy grading score.The score is calculated by determining several characteristics of the appearance of the sinus cavities. The score ranges from 0-32 (or 0-40 if frontal and sphenoid sinuses are opened at the time of surgery). A higher score indicates more severe disease."},{"outcome_type":"secondary","measure":"Change from Pre-operative score in Patient's nasal endoscopy, as measured by the Lund-Kennedy Endoscopic Score.","time_frame":"Pre-operatively; Post-operatively at 1 week, 3 weeks, 6 weeks, 12 weeks.","description":"The score is calculated by determining the amount of polyp, edema, and secretion in the nasal cavity on both sides. The score ranges from 0-12, with higher scores indicating more severe disease."},{"outcome_type":"secondary","measure":"Change from Pre-operative score in Patient's sinonasal quality of life, as measured by SNOT-22 (Sino-nasal outcome test)","time_frame":"Pre-operatively; Post-operatively at 1 week, 3 weeks, 6 weeks, 12 weeks.","description":"Validated disease-specific quality of life questionnaire (22 questions). The score ranges from 0-110, with higher scores indicating more severe disease."},{"outcome_type":"other","measure":"Findings on the pre-operative CT scan, as measured by Lund-MacKay CT Scores","time_frame":"Pre-operatively","description":"The score is calculated by determining the amount of polyp, edema, and secretion in the nasal cavity on both sides. The score ranges from 0-12, with higher scores indicating more severe disease."}]}
{"nct_id":"NCT04278677","start_date":"2020-03-31","phase":"N/A","enrollment":80,"brief_title":"Sleep Quality and Pain Medication Use Following Arthroscopic Rotator Cuff Repair","official_title":"Sleep Quality and Pain Medication Use Following Arthroscopic Rotator Cuff Repair","primary_completion_date":"2021-01-31","study_type":"Interventional","rec_status":"Enrolling by invitation","completion_date":"2021-03-31","last_update":"2020-02-20","description":"The purpose of this study is to investigate if oral melatonin reduces postoperative sleep 18 disturbances and narcotics use. We will enroll patients undergoing primary arthroscopic rotator 19 cuff repair (ARCR) at the Rothman Institute.","other_id":"2020 TJ 02","allocation":"Non-Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Single","intervention_model_description":"This is a provider-crossover study design.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients who undergo primary ARCR\r\n\r\n          -  Patient willing and able to complete postoperative surveys\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Daily melatonin use for > 1 week during the last 3 months\r\n\r\n          -  Irreparable tears\r\n\r\n          -  Revision rotator cuff repairs\r\n\r\n          -  Severe glenohumeral arthritis\r\n\r\n          -  Concurrent adhesive capsulitis\r\n\r\n          -  Age less than 18\r\n\r\n          -  Pregnancy\r\n\r\n          -  History of substance abuse (drug or alcohol)\r\n\r\n          -  Workman's comp patient or patient has current litigation pending\r\n\r\n          -  Allergy to melatonin\r\n\r\n          -  History of delirium/psychiatric/depression/ on antidepressants\r\n\r\n          -  History of insomnia/ on sleep aid medication\r\n\r\n          -  Use of prescription sedatives\r\n\r\n          -  use of Zelboraf (vemurafenib)\r\n\r\n          -  Use of all blood thinning medications besides aspirin (warfarin, plavix, lovenox,\r\n             etc.)\r\n\r\n          -  Sleep apnea\r\n      ","sponsor":"Rothman Institute Orthopaedics","sponsor_type":"Other","conditions":"Sleep Disturbance","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: melatonin","description":"Melatonin capsules to be taken for 6 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Pittsburg Sleep Quality Index (PSQI)","time_frame":"6 weeks post-surgery","description":"PSQI is a validated outcome measure for sleep quality"}]}
{"nct_id":"NCT04260230","start_date":"2020-03-31","phase":"N/A","enrollment":15,"brief_title":"Remote Monitoring of Patients at Risk of Sepsis","official_title":"Remote Monitoring of Cancer Patients at Risk of Sepsis, a Pilot Study of Using Wearable Biosensors in Patients at High Risk of Chemotherapy Associated Neutropenic Sepsis","primary_completion_date":"2020-10-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2020-10-31","last_update":"2020-02-07","description":"Chemotherapy is used to treat cancer in many thousands of patients per annum in the United Kingdom and millions worldwide. Most chemotherapy suppresses bone marrow function and causes a low white cell count (neutropenia) which is a major cause of sepsis, a potentially fatal medical emergency. Best outcomes in sepsis result from early admission to hospital with the rapid start of antibiotics and supportive care. Currently, patients starting chemotherapy are told the importance of making contact with the hospital if they feel unwell or develop a high temperature. Despite this it is common for patients to delay telephoning the Cancer Centre \"hot line\" until after enduring many hours of symptoms and ultimately being admitted to hospital very unwell and sometimes in life threatening septic shock. This proposal (REACT) seeks to invert the current model of care with the aim of improving patient outcomes whilst reducing costs. In this proof of concept pilot study we aim to assess the feasibility of using remote wearable biosensors to record key physiological parameters (including respiratory rate, heart rate and temperature) and transmit this data centrally to The Christie. We will also assess retrospectively whether perturbations in biosensor collected data correlate with clinical episodes of sepsis and if so develop bespoke clinical algorithms to identify patients displaying \"red flags\" for sepsis and guide response. Data collected by the sensors is at this stage only being reviewed retrospectively. Subsequent phases would involve recruiting larger number of patients to develop and test these algorithms with patients exhibiting 'red flags' for sepsis being contacted by the clinical team and taking appropriate action to facilitate assessment and treatment. The results of this study will determine whether working towards a randomised phase III trial comparing REACT with standard of care is an appropriate next step.","other_id":"CFTSp172","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","intervention_model_description":"Single arm open label device tolerability study.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Participants are capable of giving informed consent\r\n\r\n          2. Male or female aged 18 or over\r\n\r\n          3. Diagnosis of malignancy including:\r\n\r\n               -  Lung cancer (including both small and non-small cell lung cancers)\r\n\r\n               -  Upper gastrointestinal malignancy\r\n\r\n               -  Haematological malignancy (lymphoma, leukaemia and myeloma)\r\n\r\n          4. Planned to commence chemotherapy OR undergoing chemotherapy in an outpatient setting\r\n             as standard of care treatment with at least two cycles of treatment remaining.\r\n\r\n          5. Able to complete tolerability questionnaires.\r\n\r\n          6. Eastern Cooperative Oncology Group Performance Status <4\r\n\r\n          7. Life expectancy of greater than three months.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients hospitalized at time of commencing chemotherapy\r\n\r\n          2. Pregnant patients\r\n\r\n          3. Patients unable to give informed consent\r\n\r\n          4. Presence of ulceration or pre-existing skin rash at site of device application (left\r\n             precordium and axillae). If only one axilla affected this is not an exclusion\r\n             criterion if patient is happy to apply temperature sensor to the other axilla.\r\n\r\n          5. Radiotherapy to the left chest wall either during or within the six months preceding\r\n             the study. Plans for subsequent radiotherapy to commence after study completion are\r\n             not an exclusion criterion. If only one axilla is within the planned radiotherapy\r\n             field and patient is happy to apply temperature sensor to the other axilla this is not\r\n             an exclusion criteria.\r\n\r\n          6. History of allergy or contact dermatitis to medical adhesives e.g sticking plasters,\r\n             ECG electrodes.\r\n\r\n          7. Patients with pacemakers, implantable defibrillators or neurostimulators.\r\n\r\n          8. Patients who are currently receiving treatment as part of a clinical study or have had\r\n             their end of treatment visit for another clinical study less than 30 days prior to\r\n             Visit 1 are ineligible.\r\n\r\n          9. Patients who have planned foreign travel during the study period.\r\n      ","sponsor":"The Christie NHS Foundation Trust","sponsor_type":"Other","conditions":"Neutropenia, Febrile|Cancer|Sepsis","interventions":[{"intervention_type":"Device","name":"Device: Lifetemp/Lifetouch sensors","description":"Wearing the devices for six weeks. Data only reviewed retrospectively."}],"outcomes":[{"outcome_type":"primary","measure":"Device tolerability","time_frame":"Questionnaire at six weeks.","description":"Percentage of participants who answer 'agree' or 'strongly agree' on a five point Likert scale to the statement 'I would be happy to wear the sensors again if the data collected was being used to monitor my health during chemotherapy'. This statement is included in the questionnaires completed at the end of the device wearing period."},{"outcome_type":"secondary","measure":"Reliability of data transmission","time_frame":"Over six weeks of patients wearing devices.","description":"Reliable data transmission to central hospital system expressed as a percentage of total data points collected out of target data points collected."},{"outcome_type":"secondary","measure":"Interim device tolerability","time_frame":"Questionnaire at three weeks.","description":"Percentage of participants who answer 'agree' or 'strongly agree' on a five point Likert scale to the statement 'I would be happy to wear the sensors again for the next three weeks'. This statement is included in the questionnaires completed after three weeks of wearing the device."},{"outcome_type":"secondary","measure":"Semi-structured interviews","time_frame":"One to four weeks after completion of wearing the device.","description":"Device tolerability as assessed by semi-structured interviews."},{"outcome_type":"other","measure":"Correlation of physiological data with clinical events","time_frame":"Over 6 weeks of patients wearing devices.","description":"Exploratory analysis of sensor collected data with clinical episodes of infection. Sensor collected data includes heart rate, respiratory rate and temperature."}]}
{"nct_id":"NCT04327388","start_date":"2020-03-28","phase":"Phase 3","enrollment":420,"brief_title":"Sarilumab COVID-19","official_title":"An Adaptive Phase 3, Randomized, Double-blind, Placebo-controlled Study Assessing Efficacy and Safety of Sarilumab for Hospitalized Patients With COVID19","primary_completion_date":"2020-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-09-02","last_update":"2021-05-13","description":"Primary Objective: To evaluate the clinical efficacy of sarilumab relative to the control arm in adult participants hospitalized with severe or critical Coronavirus Disease 2019 (COVID-19). Secondary Objectives: - Evaluate the 28-day survival rate. - Evaluate the clinical efficacy of sarilumab compared to the control arm by clinical severity. - Evaluate changes in the National Early Warning Score 2. - Evaluate the duration of predefined symptoms and signs (if applicable). - Evaluate the duration of supplemental oxygen dependency (if applicable). - Evaluate the incidence of new mechanical ventilation use during the study. - Evaluate the duration of new mechanical ventilation use during the Study. - Evaluate the proportion of participants requiring rescue medication during the 28-day period. - Evaluate need for admission into intensive care unit. - Evaluate duration of hospitalization (days). - The secondary safety objectives of the study were to evaluate the safety of sarilumab through hospitalization (up to Day 29 if participant was still hospitalized) compared to the control arm as assessed by incidence of: - Serious adverse events. - Major or opportunistic bacterial or fungal infections in participants with grade 4 neutropenia. - Grade greater than or equal to (>=) 2 infusion related reactions. - Grade >=2 hypersensitivity reactions. - Increase in alanine transaminase (ALT) >=3X upper limit of normal (ULN) (for participants with normal baseline) or greater than 3X ULN AND at least 2-fold increase from baseline value (for participants with abnormal baseline). - Major or opportunistic bacterial or fungal infections.","other_id":"EFC16844","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion criteria :\r\n\r\n        Participants must be >=18 years of age. Participants must be hospitalized for less than or\r\n        equal to 7 days with evidence of pneumonia and have one of the following disease\r\n        categories: severe disease or critical disease.\r\n\r\n        Laboratory-confirmed severe acute respiratory syndrome coronavirus 2 infection.\r\n\r\n        Exclusion criteria:\r\n\r\n        Unlikely to survive after 48 hours from screening or unlikely to remain at the\r\n        investigational site beyond 48 hours. Participants with multi organ dysfunction or\r\n        requiring extracorporeal life support or renal replacement therapy were excluded.\r\n\r\n        Presence of neutropenia less than 2000/cubic millimeter (mm3), aspartate transaminase or\r\n        ALT greater than 5X ULN, platelets less than 50,000/mm3.\r\n\r\n        Prior immunosuppressive therapies. Use of systemic chronic corticosteroids for non-COVID-19\r\n        related condition. Known or suspected history of tuberculosis. Suspected or known active\r\n        systemic bacterial or fungal infections.\r\n\r\n        The above information was not intended to contain all considerations relevant to a\r\n        participant's potential participation in a clinical trial.\r\n      ","sponsor":"Sanofi","sponsor_type":"Industry","conditions":"Corona Virus Infection","interventions":[{"intervention_type":"Drug","name":"Drug: Sarilumab SAR153191","description":"Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion"}],"outcomes":[{"outcome_type":"primary","measure":"Time to Improvement in Clinical Status of Participants (Using 7-point Ordinal Scale Score) by at Least 2 Points","time_frame":"Baseline to Day 29","description":"Time to improvement of greater than or equal (>=) 2 points in clinical status assessment was defined as time (in days) from first dose of study drug to the time of first occurrence of improvement of >=2 points in clinical status of participants assessed using 7-point ordinal scale (calculated as: Date of first occurrence/episode of the event - date of first dose + 1). Seven-point ordinal scale for clinical assessment ranges from 1= death; 2= hospitalized, on invasive mechanical ventilation/ECMO; 3= hospitalized, on non-invasive ventilation/high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5= hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related/otherwise); 6= hospitalized, not requiring supplemental oxygen - no longer required ongoing medical care; 7= not hospitalized, higher score = less severity. Kaplan-Meier method was used for analysis."},{"outcome_type":"secondary","measure":"Percentage of Participants Who Were Alive at Day 29","time_frame":"Day 29","description":"Percentage of participants who were alive at Day 29 were reported in this outcome measure."},{"outcome_type":"secondary","measure":"Percentage of Participants With Improvement in Clinical Status (According to 7-point Ordinal Scale Score) by at Least 1 Point From Baseline at Days 4, 7, 15, 21, and 29","time_frame":"Baseline, Days 4, 7, 15, 21, and 29","description":"Clinical status of participants was assessed using 7-point ordinal scale ranges from: 1= death; 2= hospitalized, on invasive mechanical ventilation/ECMO; 3= hospitalized, on non-invasive ventilation/high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5= hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related/otherwise); 6= hospitalized, not requiring supplemental oxygen - no longer required ongoing medical care; 7= not hospitalized, higher score=less severity. Percentage of participants With >=1 point improvement in clinical status from Baseline at Days 4, 7, 15, 21, and 29 (assessed using the 7-point ordinal scale) were reported."},{"outcome_type":"secondary","measure":"Change From Baseline at Days 4, 7, 15, 21, 29 in 7-point Ordinal Scale Score","time_frame":"Baseline, Days 4, 7, 15, 21, and 29","description":"Clinical status of participants was assessed using 7-point ordinal scale ranges from: 1= death; 2= hospitalized, on invasive mechanical ventilation/ECMO; 3= hospitalized, on non-invasive ventilation/high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5= hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related/otherwise); 6= hospitalized, not requiring supplemental oxygen - no longer required ongoing medical care; 7= not hospitalized, higher score=less severity."},{"outcome_type":"secondary","measure":"Time to Resolution of Fever","time_frame":"Baseline to Day 29","description":"Resolution of fever was defined as body temperature less than or equal to (<=) 36.6 degree Celsius (°C) (axilla), or <=37.2°C (oral), or <=37.8°C (rectal or tympanic) for at least 48 hours without antipyretics/until discharge, whichever was sooner. Time to resolution of fever (in days) was calculated as: date of first occurrence/episode of the event (resolution of fever) - date of first dose + 1. Kaplan-Meier method was used for estimation."},{"outcome_type":"secondary","measure":"Time to Resolution of Fever and Improvement in Oxygenation","time_frame":"Baseline to Day 29","description":"Time to resolution of fever was defined as body temperature <=36.6°C (axilla), or <=37.2 °C (oral), or <=37.8°C (rectal or tympanic) for at least 48 hours without antipyretics or until discharge, whichever was sooner. Improvement in oxygenation was defined as oxygen saturation (SpO2)/FiO2 of 50 or greater compared to the nadir SpO2/FiO2 for at least 48 hours, or until discharge, whichever was sooner. Nadir SpO2/FiO2 was the nadir (lowest value) at any point in the study. Time to resolution of fever and improvement in oxygenation (in days) was calculated as: date of first occurrence/episode of the event (resolution of fever and improvement in oxygenation) - date of first dose + 1. Kaplan-Meier method was used for estimation."},{"outcome_type":"secondary","measure":"Number of Days With Fever","time_frame":"Baseline to Day 29","description":"Fever was defined as body temperature greater than (>) 37.4°C (axilla), or >38.0 °C (oral), or >38.4°C (rectal or tympanic) based on maximum value observed during a 24-hour period. Number of days with fever were reported. Least square (LS) mean and standard error (SE) were estimated using the analysis of covariance (ANCOVA) model with treatment group and randomization strata as fixed effects."},{"outcome_type":"secondary","measure":"Percentage of Participants in Each National Early Warning Score 2 (NEWS2) Clinical Risk Category at Baseline and at Days 4, 7, 15, 21, and 29","time_frame":"Baseline, Days 4, 7, 15, 21, and 29","description":"NEWS2: used to standardize assessment of acute-illness severity, track clinical condition of participants and to alert clinical teams to participant deterioration. NEWS2 score was based on 7 clinical parameters: respiration rate, oxygen saturation, supplemental oxygen, systolic blood pressure, pulse rate, level of consciousness, and temperature. A score of 0, 1, 2, and 3 was allocated to each parameter except supplemental oxygen (a score of 0 or 1 was allocated) and level of consciousness (a score of 0 or 3 was allocated), where 0 = normal health condition to 3 = worst health condition; higher score indicated more severity. All scores were summed to get an aggregate score. Aggregate NEWS2 score ranged from 0 to 19, with higher scores meaning more severity/higher risk. Percentage of participants in following clinical risk categories were reported: low risk (score 0 to 4); low to medium risk (score of 3 in any individual parameter); medium risk (score 5 to 6); high risk (score 7 to 19)."},{"outcome_type":"secondary","measure":"Time to National Early Warning Score of Less Than (<) 2 and Maintained for 24 Hours","time_frame":"Baseline to Day 29","description":"Time to NEWS2 <2 and maintained for 24 hours: time (in days) from 1st dose of study drug until 1st occurrence of NEWS score of <2 (maintained for 24 hours); calculated as: date of 1st occurrence/episode of event (NEWS score of <2) - date of 1st dose + 1. NEWS2 score was based on 7 clinical parameters: respiration rate, oxygen saturation, supplemental oxygen, systolic blood pressure, pulse rate, level of consciousness, and temperature. A score of 0, 1, 2, and 3 was allocated to each parameter except supplemental oxygen (score of 0 or 1 was allocated) and level of consciousness (score of 0 or 3 was allocated), where 0=normal health condition to 3=worst health condition; higher score=more severity. All scores were summed to get an aggregate score which ranged from 0 to 19, with higher scores=more severity/higher risk. Kaplan-Meier method was used for analysis."},{"outcome_type":"secondary","measure":"Number of Participants With Grade 4 Neutropenia and Grade 4 Neutropenia With Concurrent Invasive Infection","time_frame":"Baseline up to 60 days","description":"Grade 4 neutropenia was defined as participants with absolute neutrophil count (ANC) <500 per cubic millimeter (mm^3). Grade 4 neutropenia with concurrent invasive infection was defined as infections and infestations (in participants with Grade 4 neutropenia) within 1 week of ANC <500/mm^3 and was considered as an AESI (defined as an AE [serious or non-serious] of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required)."},{"outcome_type":"secondary","measure":"Change From Baseline at Days 4, 7, 15, 21, and 29 in National Early Warning Score 2","time_frame":"Baseline, Days 4, 7, 15, 21, and 29","description":"The NEWS2 was used to standardize the assessment of acute-illness severity, track the clinical condition of participants, and to alert clinical teams to participant deterioration. NEWS2 score is based on 7 clinical parameters: respiration rate, oxygen saturation, supplemental oxygen, systolic blood pressure, pulse rate, level of consciousness, and temperature. A score of 0, 1, 2, and 3 was allocated to each parameter except supplemental oxygen (a score of 0 or 1 was allocated) and level of consciousness (a score of 0 or 3 was allocated), where 0 = normal health condition to 3 = worst health condition; higher score indicated more severity. All scores were summed to get an aggregate score. Aggregate NEWS2 score ranged from 0 to 19, with higher scores meaning more severity/higher risk. LS means and SE were estimated using ANCOVA model with treatment group and randomization strata as fixed effects, and baseline NEWS2 score as a covariate."},{"outcome_type":"secondary","measure":"Time-to-improvement in Oxygenation","time_frame":"Baseline to Day 29","description":"Time-to-improvement in oxygenation was defined as increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2 for at least 48 hours or until discharge, whichever was sooner. Nadir SpO2/FiO2 was the nadir (lowest value) at any point in the study. Time to improvement in oxygenation was calculated as: date of first occurrence/episode of the event (oxygenation) - date of first dose + 1. Kaplan-Meier method was used for estimation."},{"outcome_type":"secondary","measure":"Percentage of Participants Alive Off Supplemental Oxygen at Day 29","time_frame":"Day 29","description":"Supplemental oxygen was defined as oxygen administration by nasal cannula, simple face mask, or other similar oxygen delivery device."},{"outcome_type":"secondary","measure":"Percentage of Days With Hypoxemia","time_frame":"Baseline to Day 29","description":"Hypoxemia (low level of oxygen in the blood) was defined as SpO2 <93% on room air, or required supplemental oxygen, or mechanical ventilatory support. Days meeting the criteria for hypoxemia since the first study dose were counted and the percentage of days with hypoxemia were calculated as:100*number of days with the hypoxemia divided by number of days of follow up (defined as the earlier date of death or discharge or last visit up to Day 29). LS mean and SE were estimated using the ANCOVA model with treatment group and randomization strata as fixed effects."},{"outcome_type":"secondary","measure":"Percentage of Days With Supplemental Oxygen Use","time_frame":"Baseline to Day 29","description":"Supplemental oxygen (oxygen therapy) was defined as oxygen administration using oxygen delivery device (e.g. nasal cannula, simple face mask, non-rebreather mask, high flow nasal cannula, non-invasive ventilation, invasive mechanical ventilation, extracorporeal life support, etc.). Days meeting the criteria for supplemental oxygen use since the first study dose were counted and the percentage of days with supplemental oxygen use were calculated as:100*number of days with the supplemental oxygen use divided by number of days of follow up (defined as the earlier date of death or discharge or last visit up to Day 29) . LS mean and SE were estimated using the ANCOVA model with treatment group and randomization strata as fixed effects."},{"outcome_type":"secondary","measure":"Percentage of Days With Resting Respiratory Rate > 24 Breaths Per Minute","time_frame":"Baseline to Day 29","description":"Resting respiratory rate was measured in terms of number of breaths per minute (bpm) while a person is at rest. Only the days with respiratory rate >24 breath per minute since the first dose were counted and percentage of days with respiratory rate > 24 bpm were calculated as:100*number of days with respiratory rate >24 bpm divided by number of days of follow up (defined as the earlier date of death or discharge or last visit up to Day 29). LS mean and SE were estimated using the ANCOVA model with treatment group and randomization strata as fixed effects."},{"outcome_type":"secondary","measure":"Time to Oxygen Saturation >= 94% on Room Air","time_frame":"Baseline to Day 29","description":"Time to oxygen saturation >=94% on room air was defined as the time (in days) from first dose of study drug until the time of first occurrence of oxygen saturation >=94% and it was calculated as: Date of first occurrence/episode of the event (oxygen saturation >=94%) - date of first dose + 1.Kaplan-Meier method was used for estimation."},{"outcome_type":"secondary","measure":"Mean Number of Ventilator Free Days","time_frame":"Baseline to Day 29","description":"Mean number of ventilator free days in participants were reported."},{"outcome_type":"secondary","measure":"Percentage of Participants With Initiation of Mechanical Ventilation, Non-invasive Ventilation, or Use of High Flow Nasal Cannula","time_frame":"Baseline to Day 29","description":"Percentage of participants With initiation of mechanical ventilation or non-invasive ventilation, or use of high flow nasal cannula were reported in this outcome measure."},{"outcome_type":"secondary","measure":"Percentage of Participants Who Required Rescue Medication","time_frame":"Baseline to Day 28","description":"Rescue medications were defined as the immunosuppressive (methylprednisolone, dexamethasone and prednisone) therapies. During the course of the study, participant who required rescue therapy was based on the judgement of the study physician."},{"outcome_type":"secondary","measure":"Percentage of Participants Who Needed Intensive Care Unit (ICU) Care During Study","time_frame":"Baseline to Day 29","description":"Percentage of participants who needed ICU care until Day 29 were reported for those not in an ICU at baseline."},{"outcome_type":"secondary","measure":"Number of Days of Hospitalization Among Survivors (Alive Participants)","time_frame":"At Day 60","description":"Number of days of hospitalization among alive participants were counted at Day 60 since the first dose. LS mean and SE were estimated using the ANCOVA model with treatment group and randomization strata as fixed effects."},{"outcome_type":"secondary","measure":"Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)","time_frame":"Baseline up to 60 days","description":"An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. Treatment-emergent AEs (TEAEs) were the AEs that developed or worsened or became serious during the TEAE period (from the time of first dose of study drug to the last dose of study drug + 60 days). SAEs were any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event."},{"outcome_type":"secondary","measure":"Number of Participants With Major or Opportunistic Bacterial or Fungal Infections","time_frame":"Baseline up to 60 days","description":"Major or opportunistic bacterial or fungal infections was considered as an adverse event of special interest (AESI: defined as an AE [serious or non-serious] of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required)."},{"outcome_type":"secondary","measure":"Number of Participants With Grade >=2 Infusion Reactions, Grade >=2 Hypersensitivity Reactions and Gastrointestinal Perforation","time_frame":"Baseline up to 60 days","description":"Grade >=2 (moderate) infusion related reactions (defined as any TEAE signs or symptoms experienced by participants who received study medication within 24 hours of the start of infusion) and Grade >=2 (moderate) hypersensitivity reactions (anaphylactic reaction, hypersensitivity or angioedema and moderate reactions) were considered as AESI which was defined as an AE (serious or non-serious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required. Gastrointestinal Perforation was defined as formation of a hole through the stomach, large bowel or small intestine."},{"outcome_type":"secondary","measure":"Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (PCSA): Hematological Parameter - Hemoglobin, Leukocytes and Platelets","time_frame":"Baseline up to 60 days","description":"Criteria for PCSA:\r\nHemoglobin: less than or equal to (<=) 115 grams per liter (g/L) (male) and <=95 g/L (female); greater than or equal to (>=) 185 g/L (male) and >=165 g/L (female); and decrease from baseline >=20 g/L.\r\nLeukocytes: <3.0*10^9/Liters (L) (Non-Black) or <2.0*10^9/L (black); >=16.0*10^9/L.\r\nPlatelets: < 100*10^9/L; >=700*10^9/L."},{"outcome_type":"secondary","measure":"Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters","time_frame":"Baseline up to 60 days","description":"Criteria for PCSA: Creatinine: >=150 micromoles per liter (mcmol/L); >=30% change from baseline; >= 100% change from baseline."},{"outcome_type":"secondary","measure":"Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters","time_frame":"Baseline up to 60 days","description":"Alanine Aminotransferase (ALT): >3 upper limit of normal (ULN); >5 ULN; >10 ULN and >20 ULN.\r\nBilirubin: >1.5 ULN; >2 ULN."}]}
{"nct_id":"NCT04241549","start_date":"2020-03-25","phase":"Phase 1","enrollment":9,"brief_title":"A Study of Cusatuzumab Plus Azacitidine in Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome Who Are Not Candidates for Intensive Treatment","official_title":"A Phase 1 Study of Cusatuzumab Plus Azacitidine in Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome Who Are Not Candidates for Intensive Treatment","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-03-31","last_update":"2021-06-02","description":"The purpose of this study is to determine the recommended Phase 2 dose and evaluate safety profile of cusatuzumab in combination with azacitidine in Japanese participants with treatment nave acute myeloid leukemia (AML) who are not candidates for intensive treatment.","other_id":"CR108732","allocation":"Non-Randomized","intervention_model":"Sequential Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  For acute myeloid leukemia (AML) participants: AML according to World Health\r\n             Organization (WHO) 2016 criteria and fulfilling all of the following criteria:(a) more\r\n             than or equal to (>=) 75 years of age, or younger participants who are not eligible\r\n             for or not willing to receive an intensive treatment (including stem cell\r\n             transplantation) with a curative intent and (b) previously untreated AML (except:\r\n             emergency leukapheresis, low dose of cytarabine and/or hydroxyurea during the\r\n             screening phase to control hyperleukocytosis but must be discontinued at least one day\r\n             prior to start of cusatuzumab [Part 1] or azacitidine [Part 2]). All trans retinoic\r\n             acid (ATRA) treatment for presumed acute promyelocytic leukemia (APL) is permitted but\r\n             must be discontinued at least 1 day prior to the start of azacitidine\r\n\r\n          -  For Myelodysplastic Syndrome (MDS) participants (only for Part 2): MDS according to\r\n             WHO 2016 criteria and fulfilling all of the following criteria: (a) Not eligible for\r\n             or not willing to receive allogenic stem cell transplantation,(b) very high or\r\n             high-risk MDS according to Revised International Prognostic Scoring System (IPSS-R)\r\n             and (c) previously untreated MDS (except: transfusion and/or cytokine therapy\r\n             including erythropoietin)\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2\r\n\r\n          -  Must sign an informed consent form (ICF) indicating that he or she understands the\r\n             purpose of, and procedures required for, the study and is willing to participate in\r\n             the study\r\n\r\n          -  A woman of childbearing potential must have a negative highly sensitive serum (beta\r\n             human chorionic gonadotropin [beta hCG]) or urine pregnancy at screening\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Acute promyelocytic leukemia (APL) with t (15;17), or its molecular equivalent\r\n             promyelocytic leukemia retinoic acid receptor (PML RAR alpha)\r\n\r\n          -  Leukemic involvement or clinical symptoms of leukemic involvement of the central\r\n             nervous system\r\n\r\n          -  Known allergies, hypersensitivity, or intolerance to cusatuzumab or azacitidine or its\r\n             excipients (example, mannitol, an excipient of azacitidine)\r\n\r\n          -  Prior treatment with a hypomethylating agent for treatment of AML or MDS\r\n\r\n          -  A diagnosis of other malignancy that requires concurrent nonsurgical treatment\r\n      ","sponsor":"Janssen Pharmaceutical K.K.","sponsor_type":"Industry","conditions":"Leukemia, Myeloid, Acute","interventions":[{"intervention_type":"Drug","name":"Drug: Cusatuzumab","description":"Cusatuzumab at a dose 20 milligram per kilogram (mg/kg) once every 2 weeks will be administered intravenously."},{"intervention_type":"Drug","name":"Drug: Azacitidine","description":"Azacitidine at a dose 75 milligram per square meters (mg/m^2) will be administered subcutaneously or intravenously."}],"outcomes":[{"outcome_type":"secondary","measure":"Part 2: Objective Response Rate (ORR)","time_frame":"Up to 9 months","description":"ORR is defined as the percentage of participants with CR, partial response (PR) and marrow CR based on response criteria per investigator assessment in participants with MDS."},{"outcome_type":"secondary","measure":"Part 1 and Part 2: Overall Survival (OS)","time_frame":"Up to 3 years","description":"OS is defined as the time from initial study intervention administration to death from any cause."},{"outcome_type":"primary","measure":"Part 1 and Part 2: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)","time_frame":"Up to 3 years","description":"Number of participants with AEs and SAEs will be reported."},{"outcome_type":"primary","measure":"Part 1 and Part 2: Number of Participants with Dose-Limiting Toxicity (DLTs)","time_frame":"Up to 42 days","description":"Number of participants with DLTs will be reported."},{"outcome_type":"primary","measure":"Part 1 and Part 2: Severity of DLT as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)","time_frame":"Up to 42 days","description":"Severity of DLT as assessed by NCI-CTCAE in participants will be reported."},{"outcome_type":"secondary","measure":"Part 1 and Part 2: Percentage of Participants with Complete Response (CR)","time_frame":"Up to 9 months","description":"Percentage of participants with complete response based on response criteria per investigator assessment in participants with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) will be reported."},{"outcome_type":"secondary","measure":"Part 1: Objective Response Rate (ORR)","time_frame":"Up to 6 months","description":"ORR is defined as percentage of participants with CR, CRh and CRi based on response criteria per investigator assessment in participants with AML."},{"outcome_type":"secondary","measure":"Part 2: Percentage of Participants with Hematologic Improvement (HI)","time_frame":"Up to 9 months","description":"Percentage of participants with hematologic improvement will be reported according to response criteria per investigator assessment in participants with MDS."},{"outcome_type":"secondary","measure":"Part 1 and Part 2: Time to Response","time_frame":"Up to 3 years","description":"Time to response is defined as time from first dose to achieving the first response of CR, CRh, or CRi in participants with AML and CR, PR or marrow CR in participants with MDS.."},{"outcome_type":"secondary","measure":"Part 1 and Part 2: Duration of Response","time_frame":"Up to 3 years","description":"Duration of response is defined as time from achieving the first response of CR, CRh, or CRi in participants with AML and CR, PR or marrow CR in participants with MDS to hematologic relapse or death of any cause."},{"outcome_type":"secondary","measure":"Part 1 and Part 2: Red Blood Cell (RBC) or Platelets Transfusion Independence","time_frame":"Up to 3 years","description":"Transfusion independence (RBC or platelets) is defined as a period of at least 56 consecutive days with no transfusion between first dose of study drug and the last dose of study drug +30 days."},{"outcome_type":"secondary","measure":"Part 1 and Part 2: Maximum Serum Concentration (Cmax) of Cusatuzumab","time_frame":"Up to 3 years","description":"Cmax is the maximum observed serum concentration."},{"outcome_type":"secondary","measure":"Part 1 and Part 2: Serum Trough Concentration (Ctrough) of Cusatuzumab","time_frame":"Up to 3 years","description":"Ctrough is the serum concentration immediately prior to the next drug administration."}]}
{"nct_id":"NCT04258865","start_date":"2020-03-25","phase":"Phase 1","enrollment":30,"brief_title":"A Clinical Trial to Compare the Pharmacokinetics and Tolerability of CKD-348","official_title":"Phase I Clinical Trial to Compare the Pharmacokinetics and Tolerability of CKD-348 With Co-administration of CKD-828, D097 and D337 in Healthy Adult Volunteers","primary_completion_date":"2020-04-26","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-05-13","last_update":"2020-06-05","description":"A clinical trial to compare the pharmacokinetics and tolerability of CKD-348","other_id":"A86_05BE1916P","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":19,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Healthy adult volunteers aged  19-year-old\r\n\r\n          2. Weight  50kg (man) or 45kg (woman), with calculated body mass index(BMI) of 18 to 30\r\n             kg/m2\r\n\r\n          3. Those who are eligible for adequate blood pressure criteria during screening tests\r\n             Systolic blood pressure: 90 to 139 mmHg Diastolic blood pressure: 60 to 89 mmHg\r\n\r\n          4. Those who have no congenital chronic disease or chronic disease requiring treatment\r\n             and who have no pathological symptoms or findings\r\n\r\n          5. Those who are eligible for clinical trials based on laboratory (hematology, blood\r\n             chemistry, serum, urine test) and 12-lead ECG results during screening tests\r\n\r\n          6. Those who agree to contraception during the participation of clinical trial\r\n\r\n          7. Those who voluntarily decide to participate and agree to comply with the cautions\r\n             after hearing and fully understanding the detailed description of this clinical trial\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Those who received investigational product or bioequivalence test drug within 6 months\r\n             before the first administration of clinical trial drug\r\n\r\n          2. Those who take barbiturate and related (causing induction or inhibition of metabolism)\r\n             drug within 1 month before the first administration of clinical trial drug\r\n\r\n          3. Those who donated whole blood and apheresis within 2 months or received transfusion\r\n             within 1 month\r\n\r\n          4. Those who has a history of gastrointestinal surgery (\r\n\r\n          5. Those who exceeding an alcohol and smoke consumption criteria Alcohol: Men - 21\r\n             glass/week, Women - 14 glass/week (1 glass: Soju 50 mL, Beer 250mL, Wine 30mL) Smoke:\r\n             20 cigarettes/day\r\n\r\n          6. Those who has a disease history of diabetic mellitus, nephropathy, biliary\r\n             obstruction, shock, dihydropyridine sensitivity, angioedema, cardiac insufficiency\r\n\r\n          7. Genetic problems such as galactose intolerance, Lapp lactose deficiency or\r\n             glucose-galactose malabsorption\r\n\r\n          8. Those who are deemed unfit by the investigators to participate in the clinical trial\r\n             for other reasons including the results of laboratory tests\r\n\r\n          9. Women who are pregnant or who may be pregnant and breastfeed\r\n      ","sponsor":"Chong Kun Dang Pharmaceutical","sponsor_type":"Industry","conditions":"Hypertension|Dyslipidemias","interventions":[{"intervention_type":"Drug","name":"Drug: CKD-348 F1","description":"QD, PO"},{"intervention_type":"Drug","name":"Drug: CKD-348 F2","description":"QD, PO"},{"intervention_type":"Drug","name":"Drug: CKD-828, D097, D337","description":"QD, PO"}],"outcomes":[{"outcome_type":"primary","measure":"AUCt of CKD-348","time_frame":"Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours","description":"AUCt: Area under the concentration-time curve from time zero to time"},{"outcome_type":"primary","measure":"Cmax of CKD-348","time_frame":"Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours","description":"Cmax: Maximum plasma concentration of the drug"},{"outcome_type":"secondary","measure":"AUCinf of CKD-348","time_frame":"Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours","description":"AUCinf: Area under the concentration-time curve from zero up to ∞"},{"outcome_type":"secondary","measure":"Tmax of CKD-348","time_frame":"Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours","description":"Tmax: Time to maximum plasma concentration"},{"outcome_type":"secondary","measure":"t1/2 of CKD-348","time_frame":"Pre-dose (0 hour)), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours","description":"t1/2: Terminal elimination half-life"},{"outcome_type":"secondary","measure":"AUCt/AUCinf of CKD-348","time_frame":"Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours","description":"AUCt/AUCinf"}]}
{"nct_id":"NCT04120454","start_date":"2020-03-16","phase":"Phase 2","enrollment":34,"brief_title":"Ramucirumab and Pembrolizumab for the Treatment of EGFR Mutant Recurrent or Metastatic Non-small Cell Lung Cancer","official_title":"An Investigator-Sponsored Phase 2 Single Arm Trial of Ramucirumab and Pembrolizumab in Patients With EGFR Mutant Non-Small Cell Lung Cancer","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-12-31","last_update":"2020-10-09","description":"This phase II trial studies how well ramucirumab and pembrolizumab work in treating EGFR mutant non-small cell lung cancer that has come back (recurrent) or spread to other places in the body (metastatic). Ramucirumab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body?s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving ramucirumab and pembrolizumab may work better in treating EGFR mutant non-small cell lung cancer compared to pembrolizumab alone.","other_id":"OSU-19132","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically confirmed recurrent or metastatic non-small cell carcinoma of the lung\r\n             with sensitizing EGFR mutations. Exon 20 resistance mutations will not be permitted\r\n             but uncommon sensitizing mutations are allowed\r\n\r\n          -  Prior systemic anticancer therapy: neo/adjuvant therapy or prior therapy for locally\r\n             advanced disease will be permitted if interval between last therapy and recurrent\r\n             disease is at least 6 months. Patients with prior exposure to PD/PD-L1 inhibitors will\r\n             be excluded. Limit of 2 prior EGFR tyrosine kinase inhibitors (TKIs) (erlotinib,\r\n             gefitinib, afatinib, dacomitinib or osimertinib). Patients who develop progressive\r\n             disease after erlotinib, gefitinib, afatinib, or dacomitinib must either receive\r\n             osimertintib (T790M positive) or be T790M negative. Prior chemotherapy for metastatic\r\n             disease is permitted only if TKI was the most recent therapy received\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Evaluation of\r\n             ECOG is to be performed within 7 days prior to the date of allocation/randomization\r\n\r\n          -  Absolute neutrophil count (ANC) >= 1500/uL (within 10 days prior to the start of study\r\n             treatment)\r\n\r\n          -  Platelets >= 100 000/uL (within 10 days prior to the start of study treatment)\r\n\r\n          -  Hemoglobin >= 9.0 g/dL or >= 5.6 mmol/L (within 10 days prior to the start of study\r\n             treatment)\r\n\r\n               -  Criteria must be met without erythropoietin dependency and without packed red\r\n                  blood cell (pRBC) transfusion within last 2 weeks\r\n\r\n          -  Creatinine =< 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine\r\n             clearance >= 40 mL/min for participant with creatinine levels > 1.5 x institutional\r\n             ULN (within 10 days prior to the start of study treatment)\r\n\r\n               -  Creatinine clearance (CrCl) should be calculated per institutional standard\r\n\r\n               -  Glomerular filtration rate (GFR) can also be used in place of creatinine or CrCl\r\n\r\n          -  Urine protein =< 1+ on dipstick or routine urinalysis (UA) (within 10 days prior to\r\n             the start of study treatment)\r\n\r\n               -  If urine dipstick or routine analysis is >= 2+, a 24-hour urine collection for\r\n                  protein must demonstrate < 1000 mg of protein in 24 hours to allow participation\r\n                  in this protocol\r\n\r\n          -  Total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for participants with total\r\n             bilirubin levels > 1.5 x ULN (within 10 days prior to the start of study treatment)\r\n\r\n          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and\r\n             alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x\r\n             ULN (=< 5 x ULN for participants with liver metastases) (within 10 days prior to the\r\n             start of study treatment)\r\n\r\n          -  International normalized ratio (INR) OR prothrombin time (PT) =< 1.5 x ULN unless\r\n             participant is receiving anticoagulant therapy as long as PT or activated partial\r\n             thromboplastin time (aPTT) is within therapeutic range of intended use of\r\n             anticoagulants (within 10 days prior to the start of study treatment)\r\n\r\n               -  Patients on full-dose anticoagulation must be on a stable dose (minimum duration\r\n                  14 days) of oral anticoagulant or low molecular weight heparin (LMWH). If\r\n                  receiving warfarin, the patient must have an INR =< 3.0. For heparin and LMWH\r\n                  there should be no active bleeding (that is, no bleeding within 14 days prior to\r\n                  first dose of protocol therapy) or pathological condition present that carries a\r\n                  high risk of bleeding (for example, tumor involving major vessels or known\r\n                  varices)\r\n\r\n          -  Activated partial thromboplastin time (aPTT) =< 1.5 x ULN unless participant is\r\n             receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of\r\n             intended use of anticoagulants (within 10 days prior to the start of study treatment)\r\n\r\n               -  Patients on full-dose anticoagulation must be on a stable dose (minimum duration\r\n                  14 days) of oral anticoagulant or low molecular weight heparin (LMWH). If\r\n                  receiving warfarin, the patient must have an INR =< 3.0. For heparin and LMWH\r\n                  there should be no active bleeding (that is, no bleeding within 14 days prior to\r\n                  first dose of protocol therapy) or pathological condition present that carries a\r\n                  high risk of bleeding (for example, tumor involving major vessels or known\r\n                  varices)\r\n\r\n          -  Because the teratogenicity of ramucirumab is not known, patients who are sexually\r\n             active, must be either postmenopausal, surgically sterile, or using effective\r\n             contraception (hormonal or barrier methods)\r\n\r\n               -  A male participant must agree to use a contraception during the treatment period\r\n                  and for at least 3 months after the last dose of study treatment and refrain from\r\n                  donating sperm during this period\r\n\r\n               -  A female participant is eligible to participate if she is not pregnant, not\r\n                  breastfeeding, and at least one of the following conditions applies:\r\n\r\n                    -  Not a woman of childbearing potential (WOCBP) OR\r\n\r\n                    -  A WOCBP who agrees to follow the contraceptive guidance during the treatment\r\n                       period and for at least 3 months after the last dose of study treatment\r\n\r\n          -  For female patients of childbearing potential, a negative serum pregnancy test within\r\n             72 hours prior to first dose of protocol therapy is required\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Active autoimmune disease that has required systemic treatment in the past 2 years\r\n             (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive\r\n             drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid\r\n             replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a\r\n             form of systemic treatment\r\n\r\n          -  Known active chronic infections ? human immunodeficiency virus (HIV)/acquired\r\n             immunodeficiency syndrome (AIDS), known active hepatitis B or C. Known history of\r\n             hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active\r\n             hepatitis C virus (defined as hepatitis C virus [HCV] ribonucleic acid [RNA]\r\n             [qualitative] is detected) infection\r\n\r\n               -  Note: no testing for hepatitis B and hepatitis C is required unless mandated by\r\n                  local health authority\r\n\r\n          -  Cirrhosis (Child-Pugh B or worse) or cirrhosis with history of hepatic encephalopathy\r\n             or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful\r\n             ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis\r\n\r\n          -  Prior exposure to ramucirumab\r\n\r\n          -  Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with\r\n             an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g.,\r\n             CTLA-4, OX-40, CD137)\r\n\r\n          -  Any grade 3-4 gastrointestinal (GI) bleeding within 3 months prior to first dose of\r\n             protocol therapy\r\n\r\n          -  History of deep vein thrombosis (DVT), pulmonary embolism (PE), or any other\r\n             significant thromboembolism (venous port or catheter thrombosis or superficial venous\r\n             thrombosis are not considered ?significant?) during the 3 months prior to first dose\r\n             of protocol therapy\r\n\r\n          -  Patients receiving chronic antiplatelet therapy, including aspirin, nonsteroidal\r\n             anti-inflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others),\r\n             dipyridamole or clopidogrel, or similar agents. Once-daily aspirin use (maximum dose\r\n             325 mg/day) is permitted\r\n\r\n          -  Untreated central nervous system (CNS) metastases. Patients with treated brain\r\n             metastases are eligible if they were clinically stable with regard to neurologic\r\n             function, off steroids after cranial irradiation (whole brain radiation therapy, focal\r\n             radiation therapy, and stereotactic radiosurgery) ending at least 2 weeks prior to\r\n             randomization, or after surgical resection performed at least 28 days prior to\r\n             randomization. The patient must have no evidence of grade >= 1 CNS hemorrhage based on\r\n             pretreatment magnetic resonance imaging (MRI) or IV contrast computed tomography (CT)\r\n             scan (performed within 21 days before randomization)\r\n\r\n          -  Hemoptysis (defined as bright red blood or >= 1/2 teaspoon) within 2 months prior to\r\n             first dose of protocol therapy or with radiographic evidence of intratumor cavitation\r\n             or has radiologically documented evidence of major blood vessel invasion or encasement\r\n             by cancer\r\n\r\n          -  Uncontrolled or poorly-controlled hypertension (> 160 mmHg systolic or > 100 mmHg\r\n             diastolic for > 4 weeks) despite standard medical management\r\n\r\n          -  Any arterial thromboembolic events, including but not limited to myocardial\r\n             infarction, transient ischemic attack, cerebrovascular accident, or unstable angina,\r\n             within 6 months prior to first dose of protocol therapy\r\n\r\n          -  Major surgery within 28 days or device placement within 7 days prior to the first dose\r\n             of protocol therapy. Patient has elective or planned major surgery to be performed\r\n             during the course of the clinical trial\r\n\r\n          -  Serious or non-healing wound, ulcer, or bone fracture within 28 days of study\r\n             treatment\r\n\r\n          -  Prior history of GI perforation/fistula (within 6 months of first dose of protocol\r\n             therapy) or risk factors for perforation\r\n\r\n          -  Small cell or mixed (small cell/non-small cell) lung cancer\r\n\r\n          -  Pregnancy or breastfeeding\r\n\r\n          -  Has received a live vaccine within 30 days prior to the first dose of study drug.\r\n             Examples of live vaccines include, but are not limited to, the following: measles,\r\n             mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus\r\n             Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection\r\n             are generally killed virus vaccines and are allowed; however, intranasal influenza\r\n             vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed\r\n\r\n          -  History of (non-infectious) pneumonitis that required steroids or has current\r\n             pneumonitis\r\n\r\n          -  History or current evidence of any condition, therapy, or laboratory abnormality that\r\n             might confound the results of the study, interfere with the subject?s participation\r\n             for the full duration of the study, or is not in the best interest of the subject to\r\n             participate, in the opinion of the treating investigator\r\n\r\n          -  Known psychiatric or substance abuse disorders that would interfere with cooperation\r\n             with the requirements of the trial\r\n\r\n          -  Severe hypersensitivity (>= grade 3) to pembrolizumab and/or any of its excipients\r\n\r\n          -  Active infection requiring systemic therapy\r\n\r\n          -  Known history of active TB (Bacillus tuberculosis)\r\n      ","sponsor":"Ohio State University Comprehensive Cancer Center","sponsor_type":"Other","conditions":"Metastatic Lung Non-Small Cell Carcinoma|Recurrent Lung Non-Small Cell Carcinoma|Stage IV Lung Cancer AJCC v8|Stage IVA Lung Cancer AJCC v8|Stage IVB Lung Cancer AJCC v8","interventions":[{"intervention_type":"Biological","name":"Biological: Pembrolizumab","description":"Given IV"},{"intervention_type":"Biological","name":"Biological: Ramucirumab","description":"Given IV"}],"outcomes":[{"outcome_type":"primary","measure":"Overall response rate","time_frame":"Up to 2 years","description":"Response rate will be evaluated with computed tomography (CT) scans every 2 cycles and tumor measurements using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Immune RECIST (iRECIST) will also be assessed."},{"outcome_type":"secondary","measure":"Incidence of adverse events","time_frame":"Up to 2 years","description":"Common Terminology Criteria for Adverse Events version 4.0 will be used for adverse event grading. Attributions of causality will be assessed by the primary treating physician. Frequency and severity of adverse events and tolerability of the regimen will be collected and summarized by descriptive statistics for each of the disease cohorts."},{"outcome_type":"secondary","measure":"Clinical benefit rate (complete response + partial response + stable disease)","time_frame":"Up to 2 years","description":"Clinical benefit rate will be evaluated with CT scans every 2 cycles and tumor measurements using RECIST 1.1 criteria. iRECIST will also be assessed."},{"outcome_type":"secondary","measure":"Progression-free survival","time_frame":"From the date of study registration to the date of progressive disease, assessed up to 2 years","description":"Kaplan-Meier curves will be calculated to estimate progression-free survival."},{"outcome_type":"secondary","measure":"Overall survival","time_frame":"From the date of study registration to the date of death, assessed up to 2 years","description":"Kaplan-Meier curves will be calculated to estimate overall survival."},{"outcome_type":"other","measure":"Tumor immunoprofile","time_frame":"Baseline","description":"Measured by immunohistochemistry, including tumor infiltrating lymphocytes and T cell receptor (TCR) immunosequencing (immunoSEQ) and relationship to clinical outcomes, including response rate. TCR immunoSEQ data will be summarized for each patient for T-cell clonality difference, descriptive statistics and confidence interval will be obtained across patients."},{"outcome_type":"other","measure":"Circulating immune cell profiles in response to treatment and in relation to clinical response","time_frame":"Up to 2 years","description":"Measured using 10-color 65 marker multiplex Clinical Laboratory Improvement Act-certified IMMUNOME flow cytometry profile on peripheral blood samples. For immune cell subpopulation data by flow cytometry, will identify differences between the paired peripheral blood mononuclear cell samples from the same patients."},{"outcome_type":"other","measure":"Change in circulating VEGF levels","time_frame":"Baseline up to 2 years","description":"Will evaluate correlation with clinical response. A bivariate plot will be used to describe the relationship between response rate and peak VEGF via enzyme-linked immunosorbent assay over time."}]}
{"nct_id":"NCT04701697","start_date":"2020-03-15","phase":"Phase 1","enrollment":36,"brief_title":"Phase Ib of Recombinant Human Albumin Injection","official_title":"Phase Ib Study of Recombinant Human Albumin Injection for the Treatment of Ascites in Patients With Hepatic Cirrhosis","primary_completion_date":"2020-09-10","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-10-25","last_update":"2021-01-08","description":"A Randomized, Multicenter,Open-label, positive-controlled, Multi-dose Phase 1 Study to Evaluate the Safety, Tolerance,Efficacy, Pharmacokinetics and Immunogenicity of recombinant human albumin injection in Patients With Hepatic Cirrhosis","other_id":"ART-2019-002","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Parallel Assignment","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. 18-75 years of age;\r\n\r\n          2. No less than 45 kg.\r\n\r\n          3. Diagnosed with ascites due to cirrhosis.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Allergy to biological products;\r\n\r\n          2. West-Haven HE  III ;\r\n\r\n          3. Uncontrolled severe infections;\r\n\r\n          4. HRS. Serum creatinine (Cr)>2ULN, or Cr increase>50% during the screening period;\r\n\r\n          5. Combined with other serious underlying diseases.\r\n\r\n          6. Organ transplant recipients;\r\n\r\n          7. Child-bearing females. Pregnancy test positive. Refusing to take contraceptive\r\n             measures; (8) Participation in other clinical trials. Using study drugs within three\r\n             month; (9) With the following laboratory test abnormality:\r\n\r\n               1. PLT<30109/L, HGB<70 g/L;\r\n\r\n               2. ALT and (or) AST> 5ULN, TBIL>3ULN;\r\n\r\n               3. Prothrombin activity <40%, PT prolonged>5s;\r\n\r\n               4. LVEF <50%;\r\n\r\n               5. The 24h urine volume exceeds 1500 mL/day ;\r\n\r\n        10) Other subjects by investigator's opinion.\r\n      ","sponsor":"The First Hospital of Jilin University","sponsor_type":"Other","conditions":"Ascites","interventions":[{"intervention_type":"Drug","name":"Drug: Recombinant Human Albumin Injection","description":"Participants will receive Recombinant Human Albumin Injection of intravenous infusion"},{"intervention_type":"Drug","name":"Drug: HumanAlbumin","description":"Participants will receive HumanAlbumin of intravenous infusion"}],"outcomes":[{"outcome_type":"primary","measure":"Safety and tolerance","time_frame":"Day 1-Day 14（approximately，After the treatment）","description":"Incidence and severity of adverse events"},{"outcome_type":"secondary","measure":"Major efficacy character: Albumin concentration change","time_frame":"Day 1-Day 14（approximately，After the treatment）","description":"Albumin concentration change from baseline to Day 14（approximately，After the treatment）"},{"outcome_type":"secondary","measure":"Efficacy：Ascites regression rate","time_frame":"Day 1-Day 14（approximately，After the treatment）","description":"Ascites regression rate from baseline at Day 14（approximately，After the treatment）"},{"outcome_type":"secondary","measure":"Efficacy：Ascites resolution time","time_frame":"Day 1-Day 14（approximately，After the treatment）","description":"Ascites resolution time"},{"outcome_type":"secondary","measure":"Efficacy： HRS (hepato-renal syndrom)","time_frame":"Day 1-Day 14（approximately，After the treatment）","description":"Incidence of HRS"},{"outcome_type":"secondary","measure":"Efficacy： OHE(overt hepatic encephalopathy)","time_frame":"Day 1-Day 14（approximately，After the treatment）","description":"Incidence of OHE"},{"outcome_type":"secondary","measure":"Efficacy： abdominal circumference","time_frame":"Day 1-Day 14（approximately，After the treatment）","description":"Change of abdominal circumference from baseline at Day 14（approximately，After the treatment）"},{"outcome_type":"secondary","measure":"Efficacy：Weight","time_frame":"Day 1-Day 14（approximately，After the treatment）","description":"Change of Weight from baseline at Day 14（approximately，After the treatment）"},{"outcome_type":"secondary","measure":"Pharmacodynamic parameters","time_frame":"Day 1-Day 29","description":"Plasma colloidal osmotic pressure change from baseline"},{"outcome_type":"secondary","measure":"PK parameters","time_frame":"Day 1-Day 29","description":"Maximum Plasma Concentration（Cmax）of ALB as Recombinant Human Albumin administration occur"},{"outcome_type":"secondary","measure":"PK parameters","time_frame":"Day 1-Day 29","description":"Time to Maximum Plasma Concentration（Tmax）of ALB as Recombinant Human Albumin administration occur"},{"outcome_type":"secondary","measure":"PK parameters","time_frame":"Day 1-Day 29","description":"Half life (t1/2）as Recombinant Human Albumin administration occur"},{"outcome_type":"secondary","measure":"PK parameters","time_frame":"Day 1-Day 29","description":"Area under the curve(AUC) as Recombinant Human Albumin administration occur"},{"outcome_type":"secondary","measure":"Immunogenicity","time_frame":"Day 1-Day 29","description":"Percentage of patients with positive reaction against human albumin"}]}
{"nct_id":"NCT04354519","start_date":"2020-03-14","enrollment":3000,"brief_title":"The United Kingdom Multiple Sclerosis Register Covid-19 Substudy","official_title":"The UK MS Regsiter COVID-19 Substudy","primary_completion_date":"2022-07-14","study_type":"Observational [Patient Registry]","rec_status":"Recruiting","completion_date":"2022-07-14","last_update":"2021-08-17","description":"The aim of the study is to understand the impact of COVID-19 on People with Multiple Sclerosis in the United Kingdom.","other_id":"16SW0194","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"PwMS in the UK who self report as having MS, or have been recruited at a clinical site.\r\n\r\n        Given the potentially vulnerable nature of pwMS due to active drug treatment and their\r\n        potential susceptibility to infection it is important to chart this population within the\r\n        MS Register","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  >18 and confirmed diagnosis of MS, enrolled on UK MS Register\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  None of the above\r\n      ","sponsor":"Swansea University","sponsor_type":"Other","conditions":"Multiple Sclerosis|COVID-19","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Incidence of COVID-19 Infections within an MS Cohort in the UK","time_frame":"Through study completion, an average of 1 year","description":"Targeted questionnaire dependent on COVID Status"},{"outcome_type":"primary","measure":"Hospitalisations in MS Patients with COVID-19","time_frame":"1 Year (regular outputs)","description":"Monitor admission rates in linked population"},{"outcome_type":"primary","measure":"Mortality","time_frame":"1 Year from study commencement","description":"Death data from routinely reported government level data (HES/PEDW)"},{"outcome_type":"secondary","measure":"Patient Reported Expanded Disability Status Score","time_frame":"1 year (at least 6 monthly)","description":"Patient Reported Outcome for MS disability"},{"outcome_type":"secondary","measure":"Hospital Anxiety and Depression Scale","time_frame":"1 year (at least 6 monthly)","description":"Patient Reported Outcome for anxiety and depression"},{"outcome_type":"secondary","measure":"Multiple Sclerosis Impact Scale 29 V2","time_frame":"1 year (at least 6 monthly)","description":"Patient Reported Outcome for Multiple sclerosis impact on physical and psychological status"},{"outcome_type":"secondary","measure":"Multiple Sclerosis Walking Scale 12 V2","time_frame":"1 year (at least 6 monthly)","description":"Patient Reported Outcome for walking status"},{"outcome_type":"secondary","measure":"Fatigue Severity Scale","time_frame":"1 year (at least 6 monthly)","description":"Patient Reported Outcome for impact of fatigue"},{"outcome_type":"secondary","measure":"EuroQol 5D (3l)","time_frame":"1 year (at least 6 monthly)","description":"Patient Reported Outcome for general quality of life"}]}
{"nct_id":"NCT04386967","start_date":"2020-03-13","phase":"Phase 1/Phase 2","enrollment":30,"brief_title":"OH2 Injection in Solid Tumors","official_title":"Open and Incremental Phase I Clinical Trial of Recombinant Human GM-CSF Type II Herpes Simplex Virus (OH2) Injection (Vero Cells) in the Treatment of Advanced Solid Tumors","primary_completion_date":"2022-03-13","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-03-13","last_update":"2021-07-21","description":"This phase I study evaluates the safety and efficacy of OH2 as single agent or in combination with Keytruda, an anti-PD-1 antibody, in patients with malignant solid tumors (Melanoma). OH2 is an oncolytic virus developed upon genetic modifications of the herpes simplex virus type 2 strain HG52, allowing the virus to selectively replicate in tumors. Meanwhile, the delivery of the gene encoding human granulocyte macrophage colony-stimulating factor (GM-CSF) may induce a more potent antitumor immune response.","other_id":"OH2-I-ST-01","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. The non-operative stage III or stage IV malignant tumor patients with clear diagnosis\r\n             by pathology and/ or cytology; breast cancer, gastrointestinal adenocarcinoma, liver\r\n             cancer, cervical cancer, malignant melanoma, head and neck tumors, Priority inclusion\r\n             in soft tissue sarcomas (mainly for melanoma patients at the dose extension phase).\r\n\r\n          2. The absence of a conventional effective treatment or treatment failure or recurrence\r\n             by a conventional method.\r\n\r\n          3. Male or female patients, aged 18  75 years (including boundary value), general\r\n             physical condition score ECOG 0  1, expected survival time more than 3 months.\r\n\r\n          4. Prior anti-tumor treatment (including endocrine, chemical/ radiotherapy,targeted\r\n             therapy) was over 4 weeks (more than 6 weeks of discontinuation using nitroso-and\r\n             mitomycin-based chemotherapy) and was recovered to grade 1 from the side effects of\r\n             prior treatment.\r\n\r\n          5. Those who have undergone major surgery will have to undergo surgery for four weeks.\r\n\r\n          6. There is at least one measurable lesion that is suitable for intratumoral injection.\r\n             According to RECIST version 1.1, it is determined that at least once the CT or MRI\r\n             examination shows the tumor lesion, it is possible to measure the tumor focus. The\r\n             measured tumor focus is defined as the longest diameter  10 mm and the scanning\r\n             thickness is not more than 5.0 mm. For lymph node lesions, the short diameter is  15\r\n             mm.\r\n\r\n          7. There is no serious dysfunction of the main organs.\r\n\r\n          8. (a) WBC3.0109LANC2.0109L PLT100109LHb90 g/L (b) BUN and Scr. were in the\r\n             upper limit of 1.5 times of the normal value; (c) TBIL 1.5 times the upper limit of\r\n             the normal value. (d) ALT and AST  2.5 times the upper limit of normal value; The\r\n             value of patients with liver metastasis did not exceed 5 times the upper limit of\r\n             normal value. (e) Coagulation function is normal (PT and APPT are within 1.5 times of\r\n             the upper limit of normal value).\r\n\r\n          9. Female subjects and their spouses received effective contraceptives during and within\r\n             3 months of treatment.\r\n\r\n         10. Subjects with herpes in the reproductive organs needed three months after the end of\r\n             herpes.\r\n\r\n         11. The informed consent was voluntarily signed and the expected compliance was good.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Severe medical diseases, including severe heart disease, cerebrovascular disease,\r\n             uncontrolled diabetes, uncontrolled hypertension, severe infection, active digestive\r\n             tract ulcer, abnormal immune function (including, but not limited to, rheumatoid\r\n             arthritis, lupus erythematosus, Sjogren's syndrome, etc.).\r\n\r\n          2. History of primary grape-film melanoma or other malignant tumors in the 3 years prior\r\n             to treatment. (use of combination drugs only)\r\n\r\n          3. Past or present immunodeficiency diseases. (use of combination drugs only)\r\n\r\n          4. Treated with PD-1/PD-L1 or PD-L2 monoantigens or inhibitors that have been used or\r\n             used in the past. (use of combination drugs only)\r\n\r\n          5. Autoimmune diseases requiring systemic treatment (e.g. steroids or immunosuppressants)\r\n             during the first 2 years of treatment, such as autoimmune pneumonia, glomerular\r\n             nephritis, vasculitis and other symptoms of autoimmune diseases; Except for wind or\r\n             child asthma. (use of combination drugs only)\r\n\r\n          6. Have uncontrolled primary or brain metastatic tumors.\r\n\r\n          7. Suffering from uncontrolled mental illness, infectious diseases.\r\n\r\n          8. The lesions cannot meet the requirements of injection capacity in the tumor body.\r\n\r\n          9. Pregnant or lactating women.\r\n\r\n         10. Other experimental therapies or antiviral therapy are used or are being used within 4\r\n             weeks of treatment.\r\n\r\n         11. Other clinical studies have been taken in the past 4 weeks.\r\n\r\n         12. Allergy to herpes virus and drug ingredients.\r\n\r\n         13. The researchers believe that there is any reason why the patient is not suitable to\r\n             participate in this trial.\r\n      ","sponsor":"Wuhan Binhui Biotechnology Co., Ltd.","sponsor_type":"Industry","conditions":"Solid Tumor|Melanoma","interventions":[{"intervention_type":"Biological","name":"Biological: OH2 injection","description":"Oncolytic Type 2 Herpes Simplex Virus"},{"intervention_type":"Drug","name":"Drug: Keytruda","description":"Anti-PD-1 antibody"}],"outcomes":[{"outcome_type":"primary","measure":"Further evaluation of dose-limiting toxicity (DLT) and maximum-tolerated dose (MTD) of OH2 in patients with solid tumors","time_frame":"12 months"},{"outcome_type":"primary","measure":"The dose-limiting toxicity (DLT) of OH2 injection and Keytruda in patients with solid tumors","time_frame":"12 months"},{"outcome_type":"primary","measure":"The maximum-tolerated dose (MTD) of OH2 injection in combination with Keytruda in patients with solid tumors","time_frame":"12 months"},{"outcome_type":"secondary","measure":"The response rate of patients with solid tumors receiving OH2 injection monotherapy and OH2 injection in combination with Keytruda","time_frame":"12 months"},{"outcome_type":"secondary","measure":"The biodistribution of OH2 injection as determined by the concentration of OH2 in blood, urine and feces of participating patients","time_frame":"12 months"},{"outcome_type":"secondary","measure":"The immunogenicity of OH2 injection as determined by the detection of antibodies in response to OH2 and GM-CSF","time_frame":"12 months"}]}
{"nct_id":"NCT04095078","start_date":"2020-03-10","phase":"N/A","enrollment":56,"brief_title":"Ancillary Home Airway Clearance in CF Patients ( HomeCareSIMEOX )","official_title":"Efficiency and Acceptability of SIMEOX Used Autonomously at Home for Bronchial Clearance in Patients With Cystic Fibrosis: Ancillary Study","primary_completion_date":"2021-09-15","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-12-15","last_update":"2021-06-29","description":"Regular bronchial clearance is essential in patients with cystic fibrosis for their bronchial health. SIMEOX (Physio-Assist, Aix en Provence, France) is an innovative medical device for the drainage of the bronchial tree. By changing the rheological properties of mucus, SIMEOX helps to mobilize secretions and assists their transport to the upper airways. This technology is based on fundamental research on bronchial mucus rheology. At the present time, SIMEOX device is mainly used over a short period at the time or after an exacerbation in healthcare structures (hospitals, physiotherapy practices, postcare, and rehabilitation units, etc). The clinical effects observed in the short term encourages long-term autonomous use by the patients themselves. The overall objective of this study is to evaluate the efficiency and acceptability of SIMEOX used at home by the patient himself for bronchial clearance in patients with cystic fibrosis.","other_id":"Ancillary Home-Care SIMEOX","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Prospective, randomized, controlled, multicenter trial","sampling_method":"","gender":"All","minimum_age":14,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  one of the 56 first patients of HOME-CARE SIMEOX study\r\n\r\n          -  same criteria as HOME-CARE SIMEOX study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  same criteria as HOME-CARE SIMEOX study\r\n      ","sponsor":"Physio-Assist","sponsor_type":"Industry","conditions":"Pulmonary Cystic Fibrosis","interventions":[{"intervention_type":"Device","name":"Device: SIMEOX","description":"Use without obligation, in autonomous and at home of the bronchial clearance device: SIMEOX"}],"outcomes":[{"outcome_type":"primary","measure":"Pulmonary static hyperinflation assessed by residual volume","time_frame":"Change from baseline at 3 months","description":"Relative variation in Pulmonary residual volume in the SIMEOX® treated group versus control group."},{"outcome_type":"secondary","measure":"Use assessed by the duration of use of SIMEOX® device","time_frame":"During 3 months of use","description":"Assess the duration of uses of the device SIMEOX by the patient in the SIMEOX® treated group to assess the use by patient of the device."},{"outcome_type":"secondary","measure":"Inspiratory capacity","time_frame":"Change from baseline at 3 months","description":"Relative variation of Inspiratory capacity in liter in the SIMEOX® treated group versus control group"},{"outcome_type":"secondary","measure":"Residual functional capacity (RFC)","time_frame":"Change from baseline at 3 months","description":"Relative variation of Residual functional capacity (RFC) in liter in the SIMEOX® treated group versus control group"},{"outcome_type":"secondary","measure":"Total lung capacity (TLC)","time_frame":"Change from baseline at 3 months","description":"Relative variation of Total lung capacity (TLC) in liter in the SIMEOX® treated group versus control group"}]}
{"nct_id":"NCT04808609","start_date":"2020-03-10","phase":"N/A","enrollment":42,"brief_title":"Smoking Cessation Pilot for People Living With HIV (PLWH)","official_title":"A Pilot Trial of a Smoking Cessation App in People Living With HIV (PLWH)","primary_completion_date":"2022-01-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2022-01-31","last_update":"2021-07-20","description":"The overall goal of this pilot study is to evaluate the feasibility of the Lumme smartphone app for smoking cessation in people living with HIV (PLWH) and evaluate its effect on smoking cessation. Mobile health (mHealth) technology can be used for achieving health equity in vulnerable groups because it is a widely available and relatively inexpensive tool for health behavior change and can be adapted to meet the needs of its end-users. Therefore, a mHealth intervention such as the Lumme App proposed through this study is timely, relevant, scalable and likely to improve health outcomes in PLWH who smoke.","other_id":"AAAS6990","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  PLWH\r\n\r\n          -   18 years old\r\n\r\n          -  own an Android smartphone\r\n\r\n          -  understand and read English\r\n\r\n          -  not pregnant or breastfeeding\r\n\r\n          -  permanent contact information\r\n\r\n          -  smokes greater than or equal to 5 cigarettes per day for the past 30 days\r\n\r\n          -  interested in quitting smoking within 30 days\r\n\r\n          -  blow  6 carbon monoxide (CO) into a breath analyzer at baseline\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  self-report being HIV-negative or unknown status\r\n\r\n          -  pregnant, breastfeeding, or planning to become pregnant during the study period\r\n\r\n          -  planning to move within 3 months of enrollment\r\n\r\n          -  a positive history of a medical condition that precludes use of the nicotine patch\r\n\r\n          -  current use of nicotine replacement therapy or other smoking cessation medications\r\n\r\n          -  current enrollment in another smoking cessation program\r\n\r\n          -  blows  5 CO into a breath analyzer at baseline.\r\n      ","sponsor":"Columbia University","sponsor_type":"Other","conditions":"Smoking Cessation|Smoking|Smoking Behaviors|Smoking Reduction|Smoking, Tobacco|Smoking, Cigarette|Hiv|HIV/AIDS","interventions":[{"intervention_type":"Device","name":"Device: Lumme mobile phone application","description":"Lumme mobile phone app provides smoking cessation support and tracks smoking behaviors"},{"intervention_type":"Behavioral","name":"Behavioral: Standard of Care","description":"Smoking cessation counseling and nicotine replacement therapy"}],"outcomes":[{"outcome_type":"primary","measure":"Change in tobacco use","time_frame":"Baseline, 12 weeks follow up","description":"This will be used to measure the efficacy of the Lumme App for Smoking Cessation in PLWH. Efficacy will be assessed based on smoking abstinence determined by self-reported 7 day point prevalence of tobacco use and confirmed via breath sample."},{"outcome_type":"primary","measure":"Change in Perceived Ease of Use and Potential Usefulness Questionnaire Score","time_frame":"Baseline, 12 weeks follow up","description":"Technology Acceptance: The Perceived Ease of Use and Potential Usefulness Questionnaire (PSSUQ) is a 14-item questionnaire that provides a method for assessing participants' perception of the usefulness of the technology. Items are scored such that higher values indicate more positive perception, where the maximum total score is 70."},{"outcome_type":"primary","measure":"Change in Health Information Technology Usability Evaluation Scale Score","time_frame":"Baseline, 12 weeks follow up","description":"Technology Acceptance: The Health Information Technology Usability Evaluation Scale (Health-ITUES) consists of 20 items rated on a five-point Likert scale from strongly disagree (1) to strongly agree (5). A higher scale value indicates higher perceived usability of the technology."}]}
{"nct_id":"NCT04264949","start_date":"2020-03-09","phase":"N/A","enrollment":80,"brief_title":"E-lombactifs: Evaluation of the Impact a Smartphone Application on Adherence an Exercise Program in Chronic Low Back Pain","official_title":"E-lombactifs: Evaluation of the Impact a Smartphone Application on Adherence an Exercise Program in Chronic Low Back Pain","primary_completion_date":"2022-09-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-12-31","last_update":"2021-08-06","description":"The main objective is to assess the impact of smartphone application on adherence to a physical exercise program in chronic low back pain patients. Adherence to a physical exercise program will be assessed at the start of the protocol, at three weeks and six months. A control group will benefit from conventional care in a rehabilitation center and an intervention group will benefit from a conventional care in a rehabilitation center accompanied by education in the use of a smartphone application including physical exercises and information about low back pain. The hypothesis of the search is that adherence is better in intervention group than control group at 6 months due to education in the use of smartphone application.","other_id":"RBHP 2019 LECHAUVE","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adult People\r\n\r\n          -  With nonspecific chronic low back pain (according to the definition of the HAS)\r\n\r\n          -  Covered under the national health insurance\r\n\r\n          -  Giving informed written consent to participate in the study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patient who do not meet the diagnostic criteria according to the definition of HAS\r\n\r\n          -  Behavioral disorders or comprehension difficulties making assessment impossible\r\n\r\n          -  Patient with a contraindication to physical exercise for medical reasons\r\n\r\n          -  Patient under guardianship, curatorship or safeguard of justice\r\n      ","sponsor":"University Hospital, Clermont-Ferrand","sponsor_type":"Other","conditions":"Chronic Low Back Pain","interventions":[{"intervention_type":"Other","name":"Other: Education in the use of smartphone app (Mon coach dos)","description":"In addition to conventional care and the therapeutic education program, GA will benefit from three education sessions (one per week) on the use of the smartphone app mon coach dos"},{"intervention_type":"Other","name":"Other: conventional care","description":"conventional care and the therapeutic education program"}],"outcomes":[{"outcome_type":"primary","measure":"EARS : exercise adherence rating scale","time_frame":"day1","description":"EARS assess the adherence in physical activity program."},{"outcome_type":"primary","measure":"EARS : exercise adherence rating scale","time_frame":"day 15","description":"EARS assess the adherence in physical activity program."},{"outcome_type":"primary","measure":"EARS : exercise adherence rating scale","time_frame":"day 180","description":"EARS assess the adherence in physical activity program."},{"outcome_type":"secondary","measure":"OSWESTRY questionnaire","time_frame":"day1, day 15, day 180","description":"Disability is measured by OSWESTRY"},{"outcome_type":"secondary","measure":"EPAP questionnaire","time_frame":"day1, day 15, day 180","description":"The perceived barriers to and facilitators of physical activity are measured by EPAP"},{"outcome_type":"secondary","measure":"Pain measurment: numeric scale","time_frame":"day1, day 15, day 180","description":"The pain is measured by numeric scale"},{"outcome_type":"secondary","measure":"6 minutes' walk test (6MWT)","time_frame":"day1, day 15, day 180","description":"Aerobic and functional capacities are measured by 6 minutes' walk test (6MWT)"},{"outcome_type":"secondary","measure":"aerobic capacities","time_frame":"day1, day 15, day 180","description":"aerobic capacities are measured by sub maximal ergocycle test"},{"outcome_type":"secondary","measure":"muscular endurance","time_frame":"day1, day 15, day 180","description":"the muscular endurance of the erector muscles of the spine is measured by Sorensen test"},{"outcome_type":"secondary","measure":"muscular endurance of the flexor muscles of the spine","time_frame":"day1, day 15, day 180","description":"the muscular endurance of the flexor muscles of the spine is measured by ITO test"},{"outcome_type":"secondary","measure":"muscular endurance of the extensor of the knee","time_frame":"day1, day 15, day 180","description":"the muscular endurance of the extensor of the knee is measured by Killy test"},{"outcome_type":"secondary","measure":"Core measurment","time_frame":"day1, day 15, day 180","description":"Core is measured by plank test"},{"outcome_type":"secondary","measure":"Flexibility on posterior chain","time_frame":"day1, day 15, day 180","description":"Flexibility on posterior chain is measured by DDS test"},{"outcome_type":"secondary","measure":"Mobility on posterior chain","time_frame":"day1, day 15, day 180","description":"Mobility on posterior chain is measured by Schober test"}]}
{"nct_id":"NCT04346342","start_date":"2020-03-06","enrollment":1122,"brief_title":"PRactice of VENTilation in COVID-19 Patients (PRoVENT-COVID)","official_title":"PRactice of VENTilation in COVID-19 Patients (PRoVENT-COVID) - an Observational Study of Invasively Ventilated Patients in the Netherlands","primary_completion_date":"2020-09-01","study_type":"Observational","rec_status":"Completed","completion_date":"2020-09-01","last_update":"2021-07-06","description":"The purpose of this national, multicenter service review is to determine and compare ventilation management in COVID-19 patients in the Netherlands, and to determine whether certain ventilation settings have an independent association with duration of ventilation. In every adult invasively ventilated COVID-19 patient from a participating ICU, granular ventilator settings and parameters will be collected from start of invasive ventilation for up to 72 hours. Follow up is until ICU and hospital discharge, and until day 90. The primary outcome includes main ventilator settings (including tidal volume, airway pressures, oxygen fraction and respiratory rate). Secondary endpoints are ventilator-free days and alive at day 28 (VFD-28); duration of mechanical ventilation; use of prone positioning and recruitment maneuvers; duration of ICU and hospital stay; incidence of kidney injury; and ICU, hospital, 28-day and 90-day mortality.","other_id":"PRoVENT-COVID","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Invasively ventilated patients with COVID-19.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  COVID-19, confirmed with polymerase chain reaction (PCR) and/or presence of typical\r\n             abnormalities on chest computer tomography (CT)\r\n\r\n          -  Suspected COVID-19 infection, with no exclusion of diagnosis\r\n\r\n          -  Having received invasive ventilation\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Age <18 years\r\n\r\n          -  Already included in the same study in another hospital\r\n\r\n          -  Having had received invasive ventilation > 24 hours in a non-participating hospital\r\n      ","sponsor":"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","sponsor_type":"Other","conditions":"COVID|Mechanical Ventilation|Acute Respiratory Failure","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Ventilation Mode","time_frame":"Day 1 to Day 3 from initiation of mechanical ventilation"},{"outcome_type":"primary","measure":"Tidal volume set","time_frame":"Day 1 to Day 3 from initiation of mechanical ventilation"},{"outcome_type":"primary","measure":"Expiratory tidal volume","time_frame":"Day 1 to Day 3 from initiation of mechanical ventilation"},{"outcome_type":"primary","measure":"Positive end-expiratory pressure","time_frame":"Day 1 to Day 3 from initiation of mechanical ventilation"},{"outcome_type":"primary","measure":"Maximum airway pressure or plateau pressure (P plateau) or peak pressure (P peak) (cm H2O);","time_frame":"Day 1 to Day 3 from initiation of mechanical ventilation"},{"outcome_type":"primary","measure":"Level of pressure support above positive end-expiratory pressure (PEEP)","time_frame":"Day 1 to Day 3 from initiation of mechanical ventilation"},{"outcome_type":"primary","measure":"Inspired fraction of oxygen","time_frame":"Day 1 to Day 3 from initiation of mechanical ventilation"},{"outcome_type":"primary","measure":"Set and measured respiratory rate","time_frame":"Day 1 to Day 3 from initiation of mechanical ventilation"},{"outcome_type":"primary","measure":"Inspiration to expiration ratio","time_frame":"Day 1 to Day 3 from initiation of mechanical ventilation"},{"outcome_type":"secondary","measure":"Number of ventilation-free days and alive at day 28","time_frame":"Until 28 days from initiation of mechanical ventilation"},{"outcome_type":"secondary","measure":"Duration of ventilation in survivors;","time_frame":"Until 28 days from initiation of mechanical ventilation","description":"time between start invasive ventilation and successful extubation in survivors"},{"outcome_type":"secondary","measure":"Use of prone positioning","time_frame":"Day 1 to Day 3 from initiation of mechanical ventilation"},{"outcome_type":"secondary","measure":"Use of recruitment maneuvers","time_frame":"Day 1 to Day 3 from initiation of mechanical ventilation"},{"outcome_type":"secondary","measure":"Incidence of acute kidney injury","time_frame":"Until 28 days from initiation of mechanical ventilation"},{"outcome_type":"secondary","measure":"Duration of ICU stay","time_frame":"Until 28 days from initiation of mechanical ventilation","description":"Time between admission and discharge ICU or death in ICU"},{"outcome_type":"secondary","measure":"Duration of hospital stay","time_frame":"Until 28 days from initiation of mechanical ventilation","description":"Time between admission and discharge from hospital or death in hospital"},{"outcome_type":"secondary","measure":"ICU mortality","time_frame":"Until 28 days from initiation of mechanical ventilation","description":"Any death during ICU stay"},{"outcome_type":"secondary","measure":"Hospital mortality","time_frame":"Until 28 days from initiation of mechanical ventilation","description":"Any death during hospital stay"},{"outcome_type":"secondary","measure":"28-day mortality","time_frame":"Until 28 days from initiation of mechanical ventilation"},{"outcome_type":"secondary","measure":"90-day mortality","time_frame":"Until 90 days from initiation of mechanical ventilation"}]}
{"nct_id":"NCT04558996","start_date":"2020-03-01","enrollment":3000,"brief_title":"Spanish Registry of Pregnant Women With COVID-19","official_title":"REGISTRO EPIDEMIOLOGICO DE COVID 19 EN GESTANTES","primary_completion_date":"2020-12-31","study_type":"Observational [Patient Registry]","rec_status":"Recruiting","completion_date":"2021-03-31","last_update":"2020-09-22","description":"Study title Spanish Registry of Pregnant Women with COVID-19 Protocol number and version Number 55/20. Version V8. Sponsors This registry is a project promoted by Dr. Oscar Martnez Prez of the Obstetrics and Gynaecology department of the Puerta de Hierro University Hospital. Principal investigator of the registry National coordinator: Dr. scar Martnez Prez. Obstetrics and Gynaecology Department. Puerta de Hierro University Hospital. Majadahonda. Epidemiologist: Maria Luisa de la Cruz Conti Researchers for each site: 100 sites from 32 Spanish provinces are included (Appendix 1) Funding Neither the hospitals nor the participating investigators will receive any financial compensation for their collaboration. A bank account has been opened at the hospital's Biomedical Research Foundation to receive donations: COV20/00021 - SARS-COV-2 and the COVID-19 disease Call financed by the Carlos III Institute of Health and co-financed with ERDF funds. Abstract Rationale: Knowledge about the impact of the SARS-CoV-2 virus on pregnancy is still scarce and all current recommendations are based on less than 100 cases published in the literature. To identify moderate effects (such as vertical transmission, obstetric morbidity, foetal death, maternal or neonatal death) and to allow accurate risk estimates, larger sample sizes than those currently available are required. Methods: Prospective observational study of pregnant women in whom SARS-CoV-2 infection is suspected at any time during pregnancy with positive test results for SARS-CoV-2, in order to create a registry of baseline characteristics of the pregnant woman, aspects related to the course of pregnancy and delivery, and related to the new-born, with an observation period of up to 14 days after delivery. Subsequently, several phased studies will be conducted to help establish and monitor the set of measures to improve the care of pregnant women. Discussion: The national registry for COVID-19 in pregnancy described here is a tool for sharing and centralizing data related to exposures to SARS-CoV-2 during pregnancy in a structured way. It should speed up the process of prospectively obtaining a large unbiased data set and will collect information at national level.","other_id":"55/20","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"Female","minimum_age":18,"population":"For the characterization of the clinical course of SARS-CoV-2 infection during pregnancy,\r\n        the pre-study sample size calculation has not been carried out, as registry-based studies\r\n        generally tend to be comprehensive without involving hypotheses.","criteria":"\n        Inclusion Criteria:\r\n\r\n        -\r\n\r\n        Patients eligible for follow-up o target population will be any pregnant woman who is\r\n        suspected or needs to be ruled out as having a SARS-CoV-2 infection at any time during\r\n        pregnancy with positive test results for SARS-CoV-2 by PCR.\r\n\r\n        Information regarding each pregnant woman's demographic characteristics, comorbidities and\r\n        current obstetric history was extracted from the medical history and the patient interview;\r\n        subsequently, age and race were categorized according to the classification used by the\r\n        Center for Disease Control and Prevention (CDC) (17).\r\n\r\n        For the selection of the control group to be collected in the same database, patients with\r\n        a negative COVID-19 delivery diagnosed by PCR screening at delivery, or less than 3 days\r\n        before, were considered.\r\n\r\n        Exclusion criteria\r\n\r\n        Pregnant women under the following conditions will be excluded from the registry:\r\n\r\n          -  Inability to give informed consent in the absence of a legal representative.\r\n\r\n          -  If, in the opinion of the researcher, findings in the physical examination, anomalies\r\n             in the results of the laboratory tests or other medical, social or psychosocial\r\n             factors could have a negative influence.\r\n\r\n          -  Loss of follow-up data prior to 6 weeks postpartum.\r\n      ","sponsor":"Puerta de Hierro University Hospital","sponsor_type":"Other","conditions":"Covid19|Pregnancy Complications|Premature Rupture of Membrane|Abruptio Placentae|Prelabor Rupture of Membranes|Stillbirth","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"MATERNAL COMPLICATIONS","time_frame":"1 year","description":"MATERNAL MORTALITY MORBIDITY"},{"outcome_type":"primary","measure":"NEONATAL INFECTION","time_frame":"1 year","description":"VERTICAL TRANSMISION"}]}
{"nct_id":"NCT04281173","start_date":"2020-03-01","enrollment":10,"brief_title":"Evaluation of Multifocal ERG and Visual Field Changes After Vitrectomy and ILM Peeling","official_title":"Evaluation of Multifocal ERG and Visual Field Changes After Vitrectomy and ILM Peeling","primary_completion_date":"2021-03-31","study_type":"Observational","rec_status":"Not yet recruiting","completion_date":"2021-06-30","last_update":"2020-02-25","description":"To evulate changes in MfERG, VF and OCT after viterctomy associated with ILM peeling.","other_id":"ERG in ILM peeling","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":75,"population":"patients with diopathic ERM,Primary full thickness macular hole, Lamellar macular hole, and\r\n        Vitromacular traction","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Idiopathic ERM,\r\n\r\n          2. Primary full thickness macular hole,\r\n\r\n          3. Lamellar macular hole, and\r\n\r\n          4. Vitromacular traction\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  1-Patients with a secondary ERM,\r\n\r\n               1. diabetic retinopathy,\r\n\r\n               2. venous occlusion,\r\n\r\n               3. retinal detachment,\r\n\r\n               4. uveitis, and\r\n\r\n               5. trauma. 2-Other ocular pathologies that could interfere with the functional\r\n                  results\r\n\r\n               1. dense cataract ,\r\n\r\n               2. glaucoma, and\r\n\r\n               3. previous retinal surgery\r\n      ","sponsor":"Assiut University","sponsor_type":"Other","conditions":"Epiretinal Membrane","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"BCVA","time_frame":"6 months","description":"after ILM peeling"}]}
{"nct_id":"NCT04741737","start_date":"2020-03-01","phase":"N/A","enrollment":532,"brief_title":"Repeat Sentinel Lymph Node Biopsy in Ipsilateral Breast Tumor Recurrence","official_title":"Repeat Sentinel Lymph Node Biopsy in Ipsilateral Breast Tumor Recurrence Without Distant Metastasis: A Single-arm, Multicenter, Prospective Study","primary_completion_date":"2024-01-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2029-01-31","last_update":"2021-07-28","description":"According to the standard treatment guidelines established until recently, in the case of ipsilateral breast tumor recurrence without systemic metastasis, salvage mastectomy or lumpectomy can be performed when either partial or whole breast radiation therapy is possible. On the other hand, there are currently no standard treatment guidelines for axillary treatment, and the evidence for this is limited. Axillary lymph node metastasis was reported to occur in about 26% of breast cancer patients who had negative sentinel lymph nodes from previous surgery for primary breast cancer and only local recurrence occurred. It is still important in the decision of treatment or adjuvant radiation therapy. However, it is known that most of the patients with ipsilateral breast recurrence do not have axillary lymph node metastasis. Therefore, performing axillary axillary surgery in all of these patients does not help the patient's survival in many cases, but rather can lead to complications such as lymphedema and seroma and postoperative wound infection. A question about the implementation of axillary lymph node resection has been raised and for this reason, it is necessary to study whether surveillance lymph node biopsy is still effective in patients with recurrence in the ipsilateral breast. Most of the studies on ipsilateral breast tumor recurrence without systemic metastasis reported to date are case reports or small retrospective studies. In addition, the combined meta-analysis also has limitations in that the study design is not uniform, and there are many cases in which primary breast cancer surgery performed total mastectomy or axillary lymph node dissection. This study is a multicenter prospective study designed to validate the clinical effectiveness of repeat-SLNB conducted in patients with ipsilateral breast tumor recurrence among patients who previously underwent breast conservation and sentinel lymph node biopsy for unilateral primary breast cancer.","other_id":"3-2020-0448","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":19,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age over 19 years old\r\n\r\n          2. Patients who are expected to undergo surgery under the diagnosis of ipsilateral breast\r\n             tumor recurrence(histologically confirmed in situ disease or invasive disease)\r\n\r\n          3. Patients who had partial mastectomy and sentinel lymph node biopsy for prior operation\r\n             for the initially diagnosed breast cancer\r\n\r\n          4. Patients considered to be axillary lymph node negative from clinical findings\r\n\r\n          5. Patients who understand and willingly participate in the study\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients with recurrence in other regions. (e.g. ipsilateral axillary lymph node,\r\n             supraclavicular lymph node, internal mammary lymph node, etc.)\r\n\r\n          2. Patients who are not eligible to perform SLNB\r\n\r\n          3. Patients who received mastectomy or axillary lymph node dissection for prior operation\r\n\r\n          4. Patients who experienced recurrence within a year from the primary operation\r\n\r\n          5. Patientes who are known to have axillary lymph node metastasis before the secondary\r\n             operation, histologically confirmed from tissue biopsy or cytology\r\n\r\n          6. Patients with systemic recurrence\r\n\r\n          7. Patients with inflammatory breast cancer\r\n\r\n        5) Pregnant and lactating patients\r\n      ","sponsor":"Gangnam Severance Hospital","sponsor_type":"Other","conditions":"Mastectomy","interventions":[{"intervention_type":"Procedure","name":"Procedure: reSLNB arm","description":"Radioisotope, blue dye, dual mapping methods are all allowed for re-SLNB mapping. Positive finding in re-SLNB is defined according to AJCC 8th edition, as micrometastasis or macrometastasis. Isolated tumor cell is considered negative. When sentinel lymph node is not identified, axillary operation is via physician's choice. When re-SLNB finding is negative, no further axillary lymph node dissection is performed. If there is node metastasis from re-SLNB, axillary lymph node dissection or radiation therapy can be performed as in physician's choice."}],"outcomes":[{"outcome_type":"primary","measure":"5 year disease free survival","time_frame":"5 years after surgery (re-SLNB)","description":"To prove non-inferiority of re-SLNB compared to ALND regarding disease free survival"},{"outcome_type":"secondary","measure":"identification rate of sentinel lymph node","time_frame":"5 years after surgery","description":"identification rate of sentinel lymph node"},{"outcome_type":"secondary","measure":"5-year overall survival","time_frame":"5 years after surgery","description":"5-year overall survival"},{"outcome_type":"secondary","measure":"5-year local recurrence free survival","time_frame":"5 years after surgery","description":"5-year local recurrence free survival"},{"outcome_type":"secondary","measure":"5-year regional recurrence free survival","time_frame":"5 years after surgery","description":"5-year regional recurrence free survival"},{"outcome_type":"secondary","measure":"5-year distant metastasis free survival","time_frame":"5 years after surgery","description":"5-year distant metastasis free survival"},{"outcome_type":"secondary","measure":"survival by adjuvant treatment","time_frame":"5 years after surgery","description":"survival analysis according to the adjuvant treatment after secondary surgery"},{"outcome_type":"secondary","measure":"survival by tumor subtype","time_frame":"5 years after surgery","description":"survival analysis by tumor subtype"},{"outcome_type":"secondary","measure":"identification rate of sentinel lymph node by tumor location","time_frame":"5 years after surgery","description":"identification rate of sentinel lymph node according to the location of primary tumor(caudal/non-caudal)"},{"outcome_type":"secondary","measure":"5-year DFS by tumor location","time_frame":"5 years after surgery","description":"5-year DFS accoridng to the location of primary tumor (caudal/non-caudal)"}]}
{"nct_id":"NCT05021159","start_date":"2020-03-01","enrollment":20,"brief_title":"Assessing the Ontogeny of P-glycoprotein Expression in Blood of Pediatric Leukemic Patients","official_title":"Assessing the Ontogeny of P-glycoprotein Expression in Blood of Pediatric Leukemic Patients","primary_completion_date":"2021-06-01","study_type":"Observational","rec_status":"Completed","completion_date":"2021-08-01","last_update":"2021-09-02","description":"Determine P-glycoprotein expression in blood samples of Acute Lymphocytic leukemia (ALL) pediatric patients receiving MTX treatment and trace its ontogeny and compare it with its expression in pediatric healthy subjects. In addition, to determine the correlation of P-glycoprotein expression and Methotrexate concentration at steady state.","other_id":"141052","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":0.08333,"maximum_age":18,"population":"Pediatric Acute Lymphocytic Leukemia Patients aged < 18 years old who are already taking\r\n        the ALL MTX protocol.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Pediatric Acute Lymphocytic Leukemia Patients\r\n\r\n          -  aged < 18 years old\r\n\r\n          -  who are already taking the ALL MTX protocol.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Severe renal impairment (eGFR< 30 mL/min/1.73 m2 at screening)\r\n\r\n               -  Critically ill patients.\r\n\r\n               -  Other types of cancer\r\n      ","sponsor":"Tanta University","sponsor_type":"Other","conditions":"Acute Lymphocytic Leukemia","interventions":[{"intervention_type":"Other","name":"Other: MTX, (but the investigator is not using any intervention, the participants are already taking it in their treatment protocol and the investigator is just analyzing p-gp expression)","description":"the investigator is not using any intervention, the participants are already taking it in their treatment protocol and the investigator is just analyzing p-gp expression"}],"outcomes":[{"outcome_type":"primary","measure":"P-gp expression in blood samples","time_frame":"42 hours","description":"P-gp expression in blood samples"},{"outcome_type":"primary","measure":"Methotrexate concentration in blood samples","time_frame":"42 hours","description":"Methotrexate concentration in blood samples"}]}
{"nct_id":"NCT04602208","start_date":"2020-03-01","enrollment":146,"brief_title":"FOCAL HIGH-INTENSITY FOCUSED ULTRASOUND FOR PRIMARY LOCALIZED PROSTATE CANCER: MIDTERM ONCOLOGICAL OUTCOMES","official_title":"FOCAL HIGH-INTENSITY FOCUSED ULTRASOUND FOR PRIMARY LOCALIZED PROSTATE CANCER: MIDTERM ONCOLOGICAL OUTCOMES","primary_completion_date":"2020-05-01","study_type":"Observational","rec_status":"Completed","completion_date":"2020-10-01","last_update":"2020-10-26","description":"Single-center evaluation of all patients treated for primary localized prostate cancer with focal HIFU from November 2009 to December 2016. To evaluate midterm oncological outcomes of focal HIFU therapy in low an intermediate risk prostate cancer.","other_id":"69HCL20_0960","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"Male","minimum_age":18,"population":"The patients with low or intermediate risk PCa (PSA <20 ng/ml, Gleason Score 7 or less and\r\n        clinical stage T2b or less) who received PGA/FT using HIFU","criteria":"\n        Inclusion Criteria:\r\n\r\n          -   The patients with low or intermediate risk PCa (PSA <20 ng/ml, Gleason score 7 or\r\n             less and clinical stage T2b or less) who received PGA/FT using HIFU were included.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who were previously treated with radiotherapy, androgen deprivation therapy\r\n             (ADT) or other treatment for their prostate cancer were excluded.\r\n      ","sponsor":"Hospices Civils de Lyon","sponsor_type":"Other","conditions":"Prostate Cancer","interventions":[{"intervention_type":"Procedure","name":"Procedure: Retrospectively review of medical data in patients treated by focal HIFU for primary localized prostate cancer","description":"This study concern the patients with localized prostate cancer treated by Focal HIFU for low or intermediate risk disease. Three surgeons experienced in HIFU performed the procedures. Patients were treated with the Ablatherm device [EDAP TMS S.A., Vaulx-en-Velin, France] until July 2013 and then with the Focal-One device [EDAP TMS S.A.]. The data of all the patients treated between November 2009 to December 2016, at Edouard Herriot Hospital (Lyon, France), were prospectively maintain within a central database and retrospectively reviewed. The study primary outcome was retreatment-free survival (RFS) defined as any additional further treatment: local (FT/PGA for in-field or out-of-field recurrences or radical prostatectomy or external beam radiotherapy or whole gland HIFU) or systemic salvage treatment, a positive biopsy revealing PCa with an ISUP grade 2 in nontreated patients, PCa metastasis or PCa specific death. The adverse events and functional outcomes were also evaluated."}],"outcomes":[{"outcome_type":"primary","measure":"Retreatment-free survival (RFS)","time_frame":"May 1, 2020","description":"The study primary outcome was retreatment-free survival (RFS) defined as any additional further treatment: local (FT/PGA for in-field or out-of-field recurrences or radical prostatectomy or external beam radiotherapy or whole gland HIFU) or systemic salvage treatment, a positive biopsy revealing PCa with an ISUP grade≥ 2 in nontreated patients, PCa metastasis or PCa specific death."}]}
{"nct_id":"NCT04296513","start_date":"2020-03-01","enrollment":150,"brief_title":"Diagnosis of Gastritis, H. Pylori Infection and Atrophic Gastritis in Dyspeptic Patients","official_title":"High-Definition White Light Endoscopy vs Optical Enhancement With High Definition Optical Magnification in the Diagnosis of Gastritis, H. Pylori Infection and Atrophic Gastritis in Dyspeptic Patients: A Randomized Controlled Trial.","primary_completion_date":"2020-10-01","study_type":"Observational","rec_status":"Completed","completion_date":"2020-11-15","last_update":"2021-02-10","description":"Gastric cancer is the third most common cause of cancer-related death worldwide (1). Upper endoscopy is necessary to detect neoplastic macroscopic features at an early stage, but subtle abnormalities in the gastric mucosa are often missed or misdiagnosed (1). Helicobacter pylori (Hp) is involved in the pathogenesis of gastric diseases, such as, peptic ulcers, gastric lymphoma, and gastric cancer. Therefore, the necessity to recognize malignant gastric lesions at an early stage is imperative.","other_id":"IECED-02012020","observational_model":"Cohort","time_perspective":"Cross-Sectional","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":80,"population":"A sample size was estimated with a 95% confidence interval and a 10% margin of error, based\r\n        on the results of C. Robles et al. All consecutive participants will have dyspepsia\r\n        according to the Rome IV criteria, and needs to be 18 years old. Participants need to have\r\n        an epigastric pain syndrome (defined as localized pain or burning pain in the upper abdomen\r\n        at least once a week, which was intermittent, nongeneralized, not relieved by defecation,\r\n        and did not meet the criteria for pathology of the gallbladder or sphincter of Oddi);\r\n        and/or a postprandial distress syndrome (defined as the presence of a nagging feeling of\r\n        postprandial fullness after normal-volume meals, and/or early satiety that prevented the\r\n        completion of a regular meal several times a week). The criteria need to be present within\r\n        the 3 months prior to enrolment, and to have started 6 months prior to diagnosis of\r\n        dyspepsia.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  above 18 years of age\r\n\r\n          -  agreed to participate in the study\r\n\r\n          -  patients with dyspepsia in accordance with Rome criteria\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  those taking NSAIDS, PPIs or antibiotics three weeks prior invitation\r\n\r\n          -  severe uncontrolled coagulopathy\r\n\r\n          -  prior history of gastric surgery\r\n\r\n          -  those pregnant or nursing females\r\n      ","sponsor":"Instituto Ecuatoriano de Enfermedades Digestivas","sponsor_type":"Other","conditions":"Gastritis, Atrophic|Helicobacter Pylori Infection|Intestinal Metaplasia|Gastritis","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: High-Definition white light endoscopy.","description":"evaluation of the gastric mucosa with high-definition white light endoscopy (EG-29i10 gastroscope and EPKi7010 video processor). The endoscopy images will be seen on a 27inch, flat panel, high definition LCD monitor (Radiance ultraSC-WU27-G1520 model) by"},{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: High-definition magnification with digital chromoendoscopy.","description":"Subject will be evaluated by upper endoscopy with the OE System (EPK-i7010 HD Video Processor and MagniView EG-2990Zi Video Gastroscope) with intravenous sedation in a standardized manner. This technique involves the use of a distal black rubber hood (OE-A58; Pentax) at the tip of the endoscope, to fix the distance between the tip of the endoscope and the gastric mucosa at 2 mm. The OE System will be used in mode 1 and mode 2 without optical magnification, to obtain an overview of the gastric body and identify any gross changes in the mucosa, then optical magnification will be implemented."}],"outcomes":[{"outcome_type":"primary","measure":"1. Overall accuracy of High-definition white light endoscopy to detect lesions compatible with gastritis, H. pylori infection, gastric atrophy or intestinal metaplasia.","time_frame":"3-month after index endoscopy","description":"histological analysis of gastritis, H. pylori infection, gastric atrophy or intestinal metaplasia."},{"outcome_type":"primary","measure":"2. Overall accuracy of optical enhancement with optical magnification to detect lesions compatible with gastritis, H. pylori infection, gastric atrophy or intestinal metaplasia.","time_frame":"3-month after index endoscopy","description":"histological analysis of gastritis, H. pylori infection, gastric atrophy or intestinal metaplasia."},{"outcome_type":"primary","measure":"3. Comparative analysis between High-definition white light endoscopy and optical enhancement with optical magnification with histological analysis.","time_frame":"1-month after finishing enrollment","description":"statistical analysis of the accuracy for both diagnostic methods"}]}
{"nct_id":"NCT04385823","start_date":"2020-03-01","enrollment":62,"brief_title":"Use of High Flow Nasal Cannula Oxygen and Covid-19 Acute Hypoxemic Respiratory Failure","official_title":"Use of High Flow Nasal Cannula Oxygen During Acute Hypoxemic Respiratory Failure Related to Covid-19 and Interest of the Respiratory-oxygenation Index (ROX Index): an Observational Study","primary_completion_date":"2020-05-04","study_type":"Observational","rec_status":"Completed","completion_date":"2020-05-04","last_update":"2020-05-13","description":"Nasal High Flow oxygen therapy (NHF) is commonly used as first line ventilatory support in patients with acute hypoxemic respiratory failure (AHRF). It's use has been initially limited in Covid-19 patients presenting with AHRF. The aim of the study is to describe the use of NHF in Covid-19-related AHRF and report the changes in the respiratory-oxygenation index (termed ROX index) over time in these patients.","other_id":"HLM_JDR9","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"all adult patients admitted to the ICU with proven Covid-19 pneumonia and acute hypoxemic\r\n        respiratory failure requiring supplemental oxygen administered via NHF","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Covid-19 pneumonia\r\n\r\n          -  acute hypoxemic respiratory failure\r\n\r\n          -  need for nasal high flow therapy as first line therapy\r\n\r\n          -  admission to intensive care\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  intubation prior to NHF therapy\r\n      ","sponsor":"Hpital Louis Mourier","sponsor_type":"Other","conditions":"Respiratory Syndrome, Acute, Severe|Hypoxic Respiratory Failure|Viral Pneumonia","interventions":[{"intervention_type":"Device","name":"Device: patients receiving nasal high flow","description":"patients admitted to the ICU for Covid-19-related acute hypoxemic respiratory failure treated with nasal high flow"}],"outcomes":[{"outcome_type":"primary","measure":"Changes in ROX index","time_frame":"from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months","description":"values of ROX index during ICU stay"},{"outcome_type":"secondary","measure":"NHF failure","time_frame":"from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months","description":"percentage of patients requiring intubation"},{"outcome_type":"secondary","measure":"NHF flow","time_frame":"from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months","description":"level of flow used with NHF"},{"outcome_type":"secondary","measure":"NHF inspired fraction in oxygen","time_frame":"from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months","description":"level of inspired fraction in oxygen used with NHF"},{"outcome_type":"secondary","measure":"oxygenation","time_frame":"from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months","description":"level of pulse oxymetry during NHF therapy"},{"outcome_type":"secondary","measure":"respiratory status","time_frame":"from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months","description":"respiratory rate during NHF therapy"},{"outcome_type":"secondary","measure":"prediction of intubation","time_frame":"from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months","description":"defining the values of ROX index associated with intubation"},{"outcome_type":"secondary","measure":"prediction of NHF success","time_frame":"from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months","description":"defining the values of ROX index associated with NHF success (no intubation required)"}]}
{"nct_id":"NCT04276428","start_date":"2020-02-28","phase":"Phase 1","enrollment":28,"brief_title":"A Study of LY3209590 in Japanese Participants With Type 2 Diabetes Mellitus","official_title":"A Multiple-Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3209590 in Japanese Patients With Type 2 Diabetes Mellitus","primary_completion_date":"2020-11-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-11-28","last_update":"2020-12-03","description":"The main purpose of this study is to evaluate the safety of a study drug known as LY3209590 in Japanese participants with type 2 diabetes. Side effects and tolerability will be documented. Blood samples will be taken to compare how the body handles the drug and how it affects blood sugar levels. The study will last almost five months for each participant.","other_id":"16983","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":74,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Have type 2 diabetes mellitus (T2DM) for at least 1 year\r\n\r\n          -  Have received a stable daily dose of basal insulin at screening\r\n\r\n          -  Have hemoglobin A1c (HbA1c) greater than or equal to ()6.5 percent (%) and less than\r\n             or equal to ()10.0% at screening\r\n\r\n          -  Have a body mass index greater than (>)18.5 and 40.0 kilograms per square meter\r\n             (kg/m) at screening\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Have received a total daily dose of insulin >1.2 units per kilogram (U/kg) of body\r\n             weight at screening\r\n\r\n          -  Have received insulins except for basal insulins\r\n\r\n          -  Have received sulfonylurea at more than half of the maximum approved dose level\r\n\r\n          -  Have a history of multiple and/or severe allergies to drugs or foods or a history of\r\n             severe anaphylactic reaction or history of significant atopy\r\n\r\n          -  Have had more than 1 episode of severe hypoglycemia within 6 months before entry\r\n      ","sponsor":"Eli Lilly and Company","sponsor_type":"Industry","conditions":"Diabetes Mellitus, Type 2","interventions":[{"intervention_type":"Drug","name":"Drug: LY3209590","description":"Administered SC."},{"intervention_type":"Drug","name":"Drug: Insulin Degludec","description":"Administered SC."}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration","time_frame":"Baseline through Day 85","description":"A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module"},{"outcome_type":"secondary","measure":"Pharmacokinetics (PK): Area Under the Drug-Plasma-Concentration-Versus-Time Curve from Time Zero to 168 Hours Postdose (AUC[0-168]) of LY3209590","time_frame":"Predose on Day 1 through Day 85","description":"PK: AUC(0-168) of LY3209590"},{"outcome_type":"secondary","measure":"Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose","time_frame":"Day 1 through Day 85","description":"PD: Change from Baseline in Fasting Plasma Glucose"}]}
{"nct_id":"NCT04252586","start_date":"2020-02-28","phase":"Phase 3","enrollment":21,"brief_title":"An Open-label Extension Study of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett Syndrome","official_title":"An Open-label Extension Trial to Investigate the Long-term Safety of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett Syndrome","primary_completion_date":"2021-06-09","study_type":"Interventional","rec_status":"Terminated","completion_date":"2021-06-09","last_update":"2021-08-09","description":"This study will be conducted to evaluate the long-term safety of cannabidiol oral solution (GWP42003-P, CBD-OS) in participants with Rett syndrome.","other_id":"GWND19002","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":2,"maximum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Participant has completed all scheduled visits of the treatment phase of the\r\n             randomized controlled trial (RCT), GWND18064 (NCT03848832), and has transitioned to\r\n             open-label extension (OLE) by the point of RCT follow-up\r\n\r\n          -  Participant (if possessing adequate understanding, in the investigator's opinion)\r\n             and/or the participant(s)/legal representative is willing and able to give informed\r\n             consent/assent for participation in the trial.\r\n\r\n          -  Participant and the participant's caregiver are willing and able (in the\r\n             investigator's opinion) to comply with all trial requirements (including the\r\n             completion of all caregiver assessments by the same caregiver throughout the trial).\r\n\r\n          -  Ability to swallow the investigational medicinal product (IMP) provided as a liquid\r\n             solution, or the ability for the IMP to be delivered via gastrostomy (G) or\r\n             nasogastric (NG) feeding tube (only G- or NG-tubes made from polyurethane or silicon\r\n             are allowed).\r\n\r\n          -  Participant and/or parent(s)/legal representative is willing to allow the responsible\r\n             authorities to be notified of participation in the trial, if mandated by local law.\r\n\r\n          -  Participant and/or parent(s)/legal representative is willing to allow the\r\n             participant's primary care practitioner (if the participant has one) and consultant\r\n             (if the participant has one) to be notified of participation in the trial, if the\r\n             primary care practitioner/consultant is different from the investigator.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Participant meets the withdrawal criteria (including clinically significant abnormal\r\n             laboratory values), in the investigator's opinion.\r\n\r\n          -  Participant met during the RCT the criteria for permanent IMP discontinuation (unless\r\n             in the case of an adverse event [AE], if the AE was not considered related with the\r\n             IMP; participants that met alanine aminotransferase (ALT)/aspartate aminotransferase\r\n             (AST) elevations discontinuation criteria must be excluded).\r\n\r\n          -  Females of childbearing potential, unless willing to ensure that they or their partner\r\n             use a highly effective method of birth control (e.g., combined [estrogen and\r\n             progestogen containing] hormonal contraception associated with inhibition of ovulation\r\n             [oral, intravaginal, or transdermal], progestogen-only hormonal contraception\r\n             associated with inhibition of ovulation [oral, injectable, or implantable],\r\n             intrauterine devices/hormone-releasing systems, bilateral tubal occlusion,\r\n             vasectomized partner, sexual abstinence during the trial and for 3 months after the\r\n             last dose\r\n\r\n          -  Participant has been previously enrolled and dosed in this trial.\r\n\r\n          -  Participant is unwilling to abstain from donation of blood during the trial.\r\n\r\n          -  Male participants who are fertile (i.e., after puberty unless permanently sterile by\r\n             bilateral orchidectomy) and with a partner of childbearing potential unless agree to\r\n             ensure that they use male contraception (e.g., condom) or remain sexually abstinent\r\n             during the trial and for 3 months after the last dose\r\n      ","sponsor":"GW Research Ltd","sponsor_type":"Industry","conditions":"Rett Syndrome|RTT","interventions":[{"intervention_type":"Drug","name":"Drug: GWP42003-P","description":"GWP42003-P presented as an oral solution containing cannabidiol in the excipients sesame oil with anhydrous ethanol, sweetener (sucralose), and strawberry flavoring"}],"outcomes":[{"outcome_type":"primary","measure":"Number of participants with suicidality, as assessed by the investigator via a clinical interview with the caregiver","time_frame":"up to Week 106"},{"outcome_type":"primary","measure":"Number of participants with any change in growth and development by measurement of height, weight, serum insulin-like growth factor-1 (IGF-1) levels, and Tanner Staging","time_frame":"up to Week 106"},{"outcome_type":"secondary","measure":"Change from prerandomization Baseline of the RCT to Week 105 in Clinical Global Impressions - Improvement (CGI-I) scores","time_frame":"from Baseline up to Week 105"},{"outcome_type":"secondary","measure":"Change from prerandomization Baseline of the RCT to Week 105 in Clinician Global Impressions - Severity Scale (CGI-S) scores","time_frame":"from Baseline up to Week 105"},{"outcome_type":"primary","measure":"Number of participants with any adverse event","time_frame":"up to Week 110"},{"outcome_type":"primary","measure":"Number of participants with any clinically significant clinical laboratory parameter value","time_frame":"up to Week 106"},{"outcome_type":"primary","measure":"Number of participants with any clinically significant vital sign value","time_frame":"up to Week 106"},{"outcome_type":"primary","measure":"Number of participants with any clinically significant physical examination procedure value","time_frame":"up to Week 106"},{"outcome_type":"primary","measure":"Number of participants with any clinically significant 12-lead electrocardiogram (ECG) value","time_frame":"up to Week 106"},{"outcome_type":"primary","measure":"Number of participants with any clinically significant effects on their menstruation cycle","time_frame":"up to Week 105"},{"outcome_type":"secondary","measure":"Change from prerandomization Baseline of the Randomized Controlled Trial (RCT) to Week 105 in Rett Syndrome Behaviour Questionnaire (RSBQ) scores","time_frame":"from Baseline up to Week 105"},{"outcome_type":"secondary","measure":"Change from prerandomization Baseline of the RCT to Week 105 in 9-item Motor Behavioral Assessment (MBA-9) scores","time_frame":"from Baseline up to Week 105"},{"outcome_type":"secondary","measure":"Change from prerandomization Baseline of the RCT to Week 105 in Children's Sleep Habits Questionnaire (CSHQ) scores","time_frame":"from Baseline up to Week 105"}]}
{"nct_id":"NCT03785067","start_date":"2020-02-27","phase":"Phase 3","enrollment":1,"brief_title":"Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT) Cognitive Sub-Study","official_title":"Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT) Cognitive Sub-Study","primary_completion_date":"2021-02-03","study_type":"Interventional","rec_status":"Terminated","completion_date":"2021-02-03","last_update":"2021-04-01","description":"A Sub-Study of an investigator initiated and conducted, multicentre, international, double-blinded, placebo-controlled, parallel-group, randomised controlled trial (TRIDENT) to determine the effect of more intensive long-term blood pressure control, provided by a fixed low-dose combination blood pressure lowering pill (\"Triple Pill\") strategy on top of standard of care, for slowing memory decline as measured by Cambridge Neuropsychological Test Automated Battery (CANTAB), in patients with a history of acute stroke due to intracerebral haemorrhage (ICH).","other_id":"TRIDENT COG","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Screening","masking_description":"Quadruple","intervention_model_description":"Main Study: Multicentre, international, double-blinded, placebo-controlled, parallel-group, randomised controlled trial.\r\nSub-Study: Multicentre, international, single-arm trial","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Eligible for, randomised and continuing in the TRIDENT Main Study\r\n\r\n          2. Must be able to attend the site conducting the cognitive assessments. In Sydney, this\r\n             will either be at the same site as where TRIDENT study is conducted or at the BMC,\r\n             University of Sydney, Camperdown.\r\n\r\n          3. Ability and willingness to undergo neuropsychological testing (i.e. have no major\r\n             visual, auditory or motor impairments)\r\n\r\n          4. Language spoken compatible with CANTAB administration (i.e. CANTAB will be\r\n             administered in the local language(s) of the country in question. E.g. in Australia,\r\n             the CANTAB will only be administered in English).\r\n\r\n          5. Provision of written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Study medication has been permanently stopped prior to or at the 6-month visit of the\r\n             TRIDENT main study\r\n\r\n          2. Informant Questionnaire for Cognitive Decline in the Elderly (IQCODE) score of 3.313\r\n             or higher\r\n\r\n          3. Cognitive performance indicative of dementia at 6-month TRIDENT main study visit\r\n             defined by Montreal Cognitive Assessment (MoCA) score less than 2414.\r\n\r\n          4. Evidence of rapid deterioration suggestive of dementia by decline of 3 points in MoCA\r\n             assessments between randomisation and the 6-month study visit in the TRIDENT main\r\n             study\r\n      ","sponsor":"The George Institute","sponsor_type":"Other","conditions":"Cognitive Decline|Intracerebral Hemorrhage|Dementia, Vascular|Cerebral Small Vessel Diseases|Hypertension|Stroke Hemorrhagic","interventions":[{"intervention_type":"Drug","name":"Drug: telmisartan 20mg + amlodipine 2.5mg +indapamide 1.25mg","description":"1 capsule taken orally once daily for 36 months"},{"intervention_type":"Drug","name":"Drug: Placebo oral capsule","description":"1 capsule taken orally once daily for 36 months"}],"outcomes":[{"outcome_type":"secondary","measure":"Change scores will be computed for CANTAB Multi-tasking Test (MTT)","time_frame":"Baseline, 18 and 36 months","description":"Change scores will be computed for CANTAB MTT between baseline, 18 and 36 months"},{"outcome_type":"secondary","measure":"Change scores will be computed for gold-standard neuropsychological assessments","time_frame":"Baseline, 18 and 36 months","description":"Change scores will be computed for gold-standard neuropsychological assessment between baseline, 18 and 36 months"},{"outcome_type":"primary","measure":"Memory as measured by the Cambridge Neuropsychological Test Automated Battery (CANTAB) Paired Associates Learning (PAL) subtest","time_frame":"Baseline, 18 and 36 months","description":"Raw scores and z-scores will be used. Change scores on the CANTAB PAL will be computed between baseline, 18 and 36 months (primary endpoint)."},{"outcome_type":"secondary","measure":"Change scores will be computed for CANTAB Rapid Visual Information Processing (RVP)","time_frame":"Baseline, 18 and 36 months","description":"Change scores will be computed for CANTAB RVP between baseline, 18 and 36 months"},{"outcome_type":"secondary","measure":"Diagnosis of all-cause dementia","time_frame":"36 months","description":"Diagnosis of all-cause dementia as determined by consensus of three blinded adjudicators based on established criteria following collection of data of the 3-year study period"}]}
{"nct_id":"NCT04230681","start_date":"2020-02-26","phase":"Early Phase 1","enrollment":300,"brief_title":"Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery","official_title":"A Randomized Controlled Trial to Compare Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery","primary_completion_date":"2022-01-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-01-31","last_update":"2021-07-27","description":"A RCT to compare hydromorphone versus fentanyl for pain control following tonsillectomy or adenotonsillectomy surgery.","other_id":"201912042","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":2,"maximum_age":15,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Children ages 2 to 15 years old\r\n\r\n          2. Presenting for tonsillectomy or adenotonsillectomy surgery\r\n\r\n          3. American Society of Anesthesiologists Physical Status (ASAPS) Classification 1, 2 or 3\r\n\r\n          4. Provide Informed Consent / Assent (as appropriate)\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Additional Concurrent surgeries, exclusive of myringotomy tubes, minor oral/nasal\r\n             procedures (e.g. frenulectomy), and endoscopic procedures\r\n\r\n          2. Revision tonsillectomy or revision adenotonsillectomy surgery\r\n\r\n          3. Known pregnancy\r\n\r\n          4. Any condition which would make the participant, in the opinion of the investigator or\r\n             the attending anesthesiologist caring for the patient, unsuitable for the study.\r\n      ","sponsor":"Washington University School of Medicine","sponsor_type":"Other","conditions":"Obstructive Sleep Apnea|Tonsillitis","interventions":[{"intervention_type":"Drug","name":"Drug: Hydromorphone","description":"Patients will be randomized to one of two opioids for the treatment of post-operative pain."},{"intervention_type":"Drug","name":"Drug: Fentanyl","description":"Fentanyl"}],"outcomes":[{"outcome_type":"primary","measure":"Amount of rescue opioid medications administered - hydromorphone group","time_frame":"up to 48 hours post surgery","description":"Postoperative opioid medication expressed in morphine equivalents"},{"outcome_type":"primary","measure":"Amount of rescue opioid medications administered - fentanyl group","time_frame":"up to 48 hours post surgery","description":"Postoperative opioid medication expressed in morphine equivalents"},{"outcome_type":"primary","measure":"Evaluation of participant's pain - hydromorphone group","time_frame":"up to 48 hours post surgery","description":"Revised Face, Legs, Activity, Cry, Consolability (rFLACC) Scale Each of the five categories (F) Face; (L) Legs; (A) Activity; (C) Cry; (C) Consolability is scored from 0-2, which results in a total score between zero and ten. 0=no pain/relaxed, 10=distressed/in pain"},{"outcome_type":"primary","measure":"Evaluation of participant's pain - fentanyl group","time_frame":"up to 48 hours post surgery","description":"Revised Face, Legs, Activity, Cry, Consolability (rFLACC) Scale Each of the five categories (F) Face; (L) Legs; (A) Activity; (C) Cry; (C) Consolability is scored from 0-2, which results in a total score between zero and ten. 0=no pain/relaxed, 10=distressed/in pain"},{"outcome_type":"secondary","measure":"Preoperative Amsterdam Preoperative Anxiety Scale - hydromorphone group","time_frame":"up to 12 hours prior to surgery","description":"Caregiver of the participant is asked questions regarding the child's anxiety level prior to surgery. The questions asked: 1) I am worried about the anesthetic, 2) The anesthetic is on my mind continually, 3) I would like to know as much as possible about the anesthetic, 4) I am worried about the procedure, 5) The procedure is on my mind continually, 6) I would like to know as much as possible about the procedure\r\nThe measure of agreement with these statements should be graded on a 5-point Likert scale from 1 \"not at all\" to 5 \"extremely.\" A score of ≥11 identify anxious patients in clinical practice."},{"outcome_type":"secondary","measure":"Preoperative Amsterdam Preoperative Anxiety Scale - fentanyl group","time_frame":"up to 12 hours prior to surgery","description":"Caregiver of the participant is asked questions regarding the child's anxiety level prior to surgery. The questions asked: 1) I am worried about the anesthetic, 2) The anesthetic is on my mind continually, 3) I would like to know as much as possible about the anesthetic, 4) I am worried about the procedure, 5) The procedure is on my mind continually, 6) I would like to know as much as possible about the procedure\r\nThe measure of agreement with these statements should be graded on a 5-point Likert scale from 1 \"not at all\" to 5 \"extremely.\" A score of ≥11 identify anxious patients in clinical practice."},{"outcome_type":"secondary","measure":"Yale Preoperative Anxiety Scale - hydromorphone group","time_frame":"up to 12 hours prior to surgery","description":"Assessing child anxiety during the induction of anesthesia. It contains 22 items in 5 categories: activity, emotional expressivity, state of arousal, vocalization, and use of parents. Each category receives a score on a scale of 0 to 4 (6 for vocalization) according to the behavior of the patient, with 0 = no anxiety and 4 (or 6 for vocalization) = high anxiety."},{"outcome_type":"secondary","measure":"Yale Preoperative Anxiety Scale - fentanyl group","time_frame":"up to 12 hours prior to surgery","description":"Assessing child anxiety during the induction of anesthesia. It contains 22 items in 5 categories: activity, emotional expressivity, state of arousal, vocalization, and use of parents. Each category receives a score on a scale of 0 to 4 (6 for vocalization) according to the behavior of the patient, with 0 = no anxiety and 4 (or 6 for vocalization) = high anxiety."},{"outcome_type":"secondary","measure":"ASA physical status classification score from preoperative assessment - hydromorphone group","time_frame":"up to 12 hours prior to surgery","description":"ASA I A normal healthy patient ASA II A patient with mild systemic disease ASA III A patient with severe systemic disease ASA IV A patient with severe systemic disease that is a constant threat to life ASA V A moribund patient who is not expected to survive without the operation ASA VI A declared brain-dead patient whose organs are being removed for donor purposes"},{"outcome_type":"secondary","measure":"ASA physical status classification score from preoperative assessment - fentanyl group","time_frame":"up to 12 hours prior to surgery","description":"ASA I A normal healthy patient ASA II A patient with mild systemic disease ASA III A patient with severe systemic disease ASA IV A patient with severe systemic disease that is a constant threat to life ASA V A moribund patient who is not expected to survive without the operation ASA VI A declared brain-dead patient whose organs are being removed for donor purposes"},{"outcome_type":"secondary","measure":"Optional opioid plasma concentrations - hydromorphone group","time_frame":"up to 48 hours after surgery","description":"Blood collection at three time points using mass spectroscopy (This is optional for participants)"},{"outcome_type":"secondary","measure":"Optional opioid plasma concentrations - fentanyl group","time_frame":"up to 48 hours after surgery","description":"Blood collection at three time points using mass spectroscopy (This is optional for participants)"},{"outcome_type":"secondary","measure":"Adverse events - hydromorphone group","time_frame":"up to 48 hours after surgery","description":"Nausea/vomiting, witnessed apneic events, desaturation events, respiratory depression, re-intubation, decreased oxygen saturation"},{"outcome_type":"secondary","measure":"Adverse events - fentanyl group","time_frame":"up to 48 hours after surgery","description":"Nausea/vomiting, witnessed apneic events, desaturation events, respiratory depression, re-intubation, decreased oxygen saturation"},{"outcome_type":"secondary","measure":"NIH PROMIS - hydromorphone group","time_frame":"up to 48 hours after surgery","description":"Patient satisfaction, behavior and pain scores over past 7 days. Scale of 1 - 6, with 1=had no pain and 6=almost always"},{"outcome_type":"secondary","measure":"NIH PROMIS - fentanyl group","time_frame":"up to 48 hours after surgery","description":"Patient satisfaction, behavior and pain scores over past 7 days. Scale of 1 - 6, with 1=had no pain and 6=almost always"},{"outcome_type":"secondary","measure":"NIH PROMIS - hydromorphone group","time_frame":"up to 48 hours after surgery","description":"Patient caregiver satisfaction, behavior and pain scores over past 7 days. Scale of 1 - 6, with 1=had no pain and 6=almost always"},{"outcome_type":"secondary","measure":"NIH PROMIS - fentanyl group","time_frame":"up to 48 hours after surgery","description":"Patient caregiver satisfaction, behavior and pain scores over past 7 days. Scale of 1 - 6, with 1=had no pain and 6=almost always"},{"outcome_type":"secondary","measure":"Child Hospital Survey (CAHPS) - hydromorphone group","time_frame":"up to 48 hours after surgery","description":"Patient caregiver satisfaction. Scale of 1 - 4 with 1=never and 6=always"},{"outcome_type":"secondary","measure":"Child Hospital Survey (CAHPS) - fentanyl group","time_frame":"up to 48 hours after surgery","description":"Patient caregiver satisfaction. Scale of 1 - 4 with 1=never and 6=always"}]}
{"nct_id":"NCT04200482","start_date":"2020-02-21","phase":"Phase 2","enrollment":90,"brief_title":"Lifestyle Program (Scalable Nutrition and Physical Activity) for the Improvement of Nutrition and Physical Activity in Stage 0-III Breast Cancer Survivors","official_title":"Testing a Scalable Nutrition and Physical Activity Program for Breast Cancer Survivors: A Dose-Finding Pilot Study","primary_completion_date":"2021-09-30","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2021-09-30","last_update":"2021-08-04","description":"The purpose of this phase II trial is to identify the most effective dose level (number of classes) of a diet and physical activity lifestyle program based on how well it improves diet and physical activity in stage 0-III breast cancer survivors. Study results may provide researchers with information on how to best implement diet and physical activity recommendations among breast cancer survivors.","other_id":"RG1006427","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Previous diagnosis of stage 0-III breast cancer in the past 10 years at the time of\r\n             enrollment\r\n\r\n          -  No evidence of recurrent or metastatic disease\r\n\r\n          -  No uncontrolled diabetes mellitus defined as glycosylated hemoglobin (Hgb A1C) > 8%\r\n\r\n          -  No uncontrolled hypertension per Seattle Cancer Care Alliance (SCCA) standard of care\r\n\r\n          -  At least 60 days post final chemotherapy, biologic therapy, or radiation therapy\r\n             and/or surgery. Current use of endocrine therapy is permitted (e.g., tamoxifen and\r\n             aromatase inhibitors)\r\n\r\n          -  Access to phone for study contacts\r\n\r\n          -  Access to smartphone, tablet, or computer and internet to attend online session(s) and\r\n             receive study electronic eHealth communication (text messages and access to website)\r\n\r\n          -  Willing and able to attend the online session(s) on Saturdays, or via online accessed\r\n             videos, for up to 12 sessions in 6 months\r\n\r\n          -  Successfully complete all run-in activities, including at-home and over the phone\r\n             assessments, 7 days of collecting physical activity data via accelerometer, and\r\n             providing blood and stool sample\r\n\r\n          -  Willing and able to complete all study activities for 6 months after randomization\r\n\r\n          -  Participants must consume < 5 servings of fruits and vegetables per day and/or engage\r\n             in < 150 minutes per week of moderate to vigorous physical activity, as assessed by\r\n             brief questionnaires\r\n\r\n          -  Participants must have an Eastern Cooperative Oncology Group (ECOG) Scale of\r\n             performance status score of 0 or 1 for performance status.\r\n\r\n          -  Signed physician approval for diet change and physical activity\r\n\r\n          -  Able to understand and willing to sign written informed electronic (e) consent in\r\n             English\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Participants must not be active smokers within the past 30 days.\r\n\r\n          -  Women must not be pregnant at time of enrollment\r\n      ","sponsor":"Fred Hutchinson Cancer Research Center","sponsor_type":"Other","conditions":"Anatomic Stage 0 Breast Cancer AJCC v8|Anatomic Stage I Breast Cancer AJCC v8|Anatomic Stage IA Breast Cancer AJCC v8|Anatomic Stage IB Breast Cancer AJCC v8|Anatomic Stage II Breast Cancer AJCC v8|Anatomic Stage IIA Breast Cancer AJCC v8|Anatomic Stage IIB Breast Cancer AJCC v8|Anatomic Stage III Breast Cancer AJCC v8|Anatomic Stage IIIA Breast Cancer AJCC v8|Anatomic Stage IIIB Breast Cancer AJCC v8|Anatomic Stage IIIC Breast Cancer AJCC v8|Prognostic Stage 0 Breast Cancer AJCC v8|Prognostic Stage I Breast Cancer AJCC v8|Prognostic Stage IA Breast Cancer AJCC v8|Prognostic Stage IB Breast Cancer AJCC v8|Prognostic Stage II Breast Cancer AJCC v8|Prognostic Stage IIA Breast Cancer AJCC v8|Prognostic Stage IIB Breast Cancer AJCC v8|Prognostic Stage III Breast Cancer AJCC v8|Prognostic Stage IIIA Breast Cancer AJCC v8|Prognostic Stage IIIB Breast Cancer AJCC v8|Prognostic Stage IIIC Breast Cancer AJCC v8","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: One Diet and Physical Activity Session","description":"Attend 1 remote diet and physical activity session"},{"intervention_type":"Other","name":"Other: Electronic (e) Health (eHealth) Communication Intervention","description":"Receive eHealth communication intervention"},{"intervention_type":"Behavioral","name":"Behavioral: Twelve Diet and Physical Activity Group Sessions","description":"Attend 12 remote diet and physical activity sessions in 6 months"},{"intervention_type":"Other","name":"Other: Questionnaire Administration","description":"Ancillary studies"},{"intervention_type":"Other","name":"Other: Quality-of-Life Assessment","description":"Ancillary studies"}],"outcomes":[{"outcome_type":"primary","measure":"Accrual rate","time_frame":"At 6 months","description":"Accrual rate will be measured by number of participants randomized during each month of study accrual."},{"outcome_type":"primary","measure":"Adherence: Session(s) Attendance","time_frame":"At 6 months","description":"Adherence will be measured by number of online session(s) attended per participant."},{"outcome_type":"primary","measure":"Adherence: Responsiveness to eHealth communication","time_frame":"At 6 months","description":"Adherence will be measured by the number of responses to text messages per participant."},{"outcome_type":"primary","measure":"Biospecimen collection rate","time_frame":"At 6 months","description":"Biospecimen collection rate will be assessed based on number of biospecimens collected."},{"outcome_type":"primary","measure":"Retention","time_frame":"At 6 months","description":"Retention will be measured by the number of completed study assessments per participants."},{"outcome_type":"primary","measure":"Acceptability: Questions during exit interview","time_frame":"At 6 months","description":"Acceptability will be measured by questions asking about trial acceptability in the exit questionnaire."},{"outcome_type":"secondary","measure":"Change in daily servings of fruits and vegetables per day","time_frame":"Baseline to 6 months","description":"Will be assessed by 24-hour dietary recalls."},{"outcome_type":"secondary","measure":"Change in minutes per week of moderate-to-vigorous physical activity","time_frame":"Baseline to 6 months","description":"Will be assessed by 7-day accelerometer data."},{"outcome_type":"secondary","measure":"Change in systemic inflammation","time_frame":"Baseline to 6 months","description":"Will be assessed by fasting blood concentrations of high sensitivity C-reactive protein."},{"outcome_type":"secondary","measure":"Change in gut barrier permeability","time_frame":"Baseline to 6 months","description":"Will be assessed by fasting circulating levels of gut bacterial endotoxin liposaccharide-binding protein."}]}
{"nct_id":"NCT03877172","start_date":"2020-02-17","phase":"N/A","enrollment":40,"brief_title":"High Flow Nasal Cannula in Thoracic Surgery: a Physiologic Study","official_title":"High Flow Nasal Cannula in Thoracic Surgery: a Physiologic Study","primary_completion_date":"2020-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2020-12-31","last_update":"2020-02-12","description":"The goal of this study is to evaluate the role that high-flow nasal cannulas (HFNC) have on respiratory drive, work of breathing and neuromuscular efficiency after lung resection surgery. The main question the investigators aim to answer is whether HFNC decrease respiratory drive by at least 15% in these patients, assessed by a special diaphragmatic electromyography (EMG) device (NAVA catheter). In order, to perform this study, the investigators will perform a physiological study in 40 patients. These patients will be assessed in the immediate postoperative period and HFNC will be compared to conventional face-mask therapy.","other_id":"HCB/2019/0049","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subjects submitted to lung resection with an expected mechanical ventilation time of\r\n             more than 180 minutes.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patient refusal to participate\r\n\r\n          -  Contraindications to nasogastric tube placement (i.e. oesophageal varices)\r\n\r\n          -  Patients less than 18 years old\r\n\r\n          -  Pregnancy\r\n\r\n          -  Neuromuscular disease\r\n\r\n          -  Prior thoracic surgery\r\n      ","sponsor":"Hospital Clinic of Barcelona","sponsor_type":"Other","conditions":"Thoracic Surgery|Respiratory Failure","interventions":[{"intervention_type":"Device","name":"Device: High-flow nasal cannula","description":"To provide high-flow nasal cannula in the immediate postoperative period after lung resection surgery as compared to conventional face-mask therapy, in a randomized sequence, for 30 minutes."}],"outcomes":[{"outcome_type":"secondary","measure":"Diaphragmatic excursion","time_frame":"An ultrasound will be performed 25 minutes after starting each study condition","description":"Diaphragmatic excursion will be assessed on each side and measured in millimeters"},{"outcome_type":"primary","measure":"Respiratory drive","time_frame":"Mean or median EAdi for both conditions (30 minutes each)","description":"Respiratory drive will be assessed as maximal EMG activity during each respiratory cycle (peak EAdi of the NAVA catheter)"},{"outcome_type":"secondary","measure":"Thickening fraction of the right hemidiaphragm","time_frame":"An ultrasound will be performed 25 minutes after starting each study condition","description":"Diaphragm thickness will be assessed at end-inspiration and end-expiration and presented as percentage of change."},{"outcome_type":"secondary","measure":"Oxygenation","time_frame":"An arterial blood sample will be obtained at the end (30 min) of each study condition","description":"Arterial oxygen pressure to inspired oxygen fraction ratio (PF ratio)"},{"outcome_type":"secondary","measure":"Ventilation","time_frame":"An arterial blood sample will be obtained at the end (30 min) of each study condition","description":"Arterial pressure of carbon dioxide (CO2)"},{"outcome_type":"secondary","measure":"Dyspnea","time_frame":"Dyspnea presence by VAS will be assessed at the 30-minute mark of each condition (end of each condition) and will evaluate dyspnea for the whole condition (30 minutes).","description":"The presence of dyspnea will be assessed by a visual analog scale (VAS). This scale presents a range of discrete values from 0 to 10; with lower values indicating less symptoms and higher values indicating more symptoms. Participants will subjectively rate their own level of dyspnea."}]}
{"nct_id":"NCT04253912","start_date":"2020-02-12","phase":"Phase 2","enrollment":90,"brief_title":"Topical 2% Povidone-Iodine Gel in Verruca Vulgaris","official_title":"A Phase 2, Double-Blind, Randomized, Parallel Group, Placebo-Controlled, Study to Evaluate Topical 2% Povidone-Iodine Gel (VBP-245) in Subjects With Verruca Vulgaris","primary_completion_date":"2021-01-05","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2021-04-30","last_update":"2021-04-01","description":"This is a multi-center, randomized, double-blind, placebo-controlled phase 2 study in subjects 8 years of age and older who present with verruca vulgaris (common warts) and desire treatment. Subjects may have up to a total of 6 common warts located on their trunk or extremities that will be treated with study medication and followed throughout the study protocol therapy. All warts will be treated two times per day (BID) for12 weeks. Approximately 90 subjects will be enrolled in this study.","other_id":"VBP-245-WART2A","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":8,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subject is able to comprehend and is willing to sign an informed consent/assent for\r\n             participation in this study.\r\n\r\n          -  Male or female  8 years old.\r\n\r\n          -  Subject has a clinical diagnosis of verruca vulgaris (common warts).\r\n\r\n          -  Subject has up to 6 warts located on the trunk or extremities\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subject has clinically atypical warts on the trunk or extremities.\r\n\r\n          -  Subject is immunocompromised (e.g., due to chemotherapy, systemic steroids, genetic\r\n             immunodeficiency, transplant status, etc.)\r\n\r\n          -  Subject has periungual, subungual, genital, anal, mosaic, plantar, flat, or filiform\r\n             wart identified as a wart for study treatment.\r\n      ","sponsor":"Veloce BioPharma LLC","sponsor_type":"Industry","conditions":"Warts","interventions":[{"intervention_type":"Drug","name":"Drug: VBP-245","description":"2% Povidone-Iodine Gel"},{"intervention_type":"Drug","name":"Drug: Placebo Gel (no Povidone-Iodine)","description":"Placebo Gel (no Povidone-Iodine)"}],"outcomes":[{"outcome_type":"primary","measure":"Decrease in wart diameter (mm)","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"Resolution of wart","time_frame":"12 weeks","description":"Wart diameter = 0 mm"},{"outcome_type":"secondary","measure":"Application Site Reaction Adverse Events","time_frame":"12 weeks"}]}
{"nct_id":"NCT04254055","start_date":"2020-02-08","phase":"N/A","enrollment":30,"brief_title":"Plyometric, Proprioceptive and Strength Exercises in Rugby Players.","official_title":"Effectiveness of a Training Program Through Plyometric, Proprioceptive and Strength Exercises in Order to Observe an Improvement of the Strength, Stability and Functional Stability of the Shoulder in Rugby Players","primary_completion_date":"2020-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-05-10","last_update":"2021-09-02","description":"Introduction. Shoulder injury is the pathology that causes the longest downtime in rugby players, representing 66% of upper limb injuries in this discipline. The lack of strength, and instability are factors that predispose the athlete to suffer this type of dysfunction. The intervention of the study consists of a training program that counteract these dysfunctions. Aim. Assess the effectiveness of a program using plyometric, proprioceptive and strength exercises on 18-45-year-old rugby players to improve strength and stability. Study design. Clinical randomized, prospective, single-blind and trackable. Methods. The subjects included in two study groups, experimental and control, will be attributed a random order. The treatment will last 4 weeks, with 2 weekly sessions, of approximately 25 minutes each. The study variables will be strength, stability and functionality. A descriptive statistical analysis will be carried out calculating the main statistical characteristics. Through of a Kolmogorov analysis the normality of the sample will be assessed. A t-Student test for paired samples will be performed for the difference between the means of the dependent and independent variables. An analysis if variance (ANOVA) for repeated measures will be used to compare the means and checked to what extent the intra-subjects factors influence the dependent variables. Expected results. Improved shoulder strength, stability and functionality for the subjects on which the study is carried out.","other_id":"FEF","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Federated rugby players\r\n\r\n          -  Male\r\n\r\n          -  18 to 45 years old\r\n\r\n          -  Currently participating in regional competitions\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Being treated with anti-inflammatory drugs\r\n\r\n          -  Having suffered an upper limb injury in the month prior to the intervention\r\n\r\n          -  Have undergone surgery for any shoulder pathology during the previous 12 months\r\n\r\n          -  Who have suffered or suffer from a serious and / or metabolic disease\r\n\r\n          -  That they have not signed the informed consent\r\n      ","sponsor":"Investigacin en Hemofilia y Fisioterapia","sponsor_type":"Other","conditions":"Overhead Athletes","interventions":[{"intervention_type":"Other","name":"Other: exercises","description":"Those subjects included in the experimental group will receive an intervention through a program with plyometric, proprioceptive and strength exercises. The subjects included in the control group will not receive any intervention."}],"outcomes":[{"outcome_type":"primary","measure":"Change from baseline strength after treatment and at 1 month","time_frame":"Screening visit, within the first seven days after treatment and after one month follow-up visit","description":"The strength assessment will be carried out with a dynamometer. The subject will stand up and the examiner will indicate when the movement should begin. The dynamometer will be positioned to measure the strength of the shoulder abductors and rotators in the position of 90º of abduction and 90º of external rotation. The unit of measure is the Newton"},{"outcome_type":"secondary","measure":"Change from baseline stability after treatment and at 1 month","time_frame":"Screening visit, within the first seven days after treatment and after one month follow-up visit","description":"It will be assessed with the Closed Kinetic Chain Upper Extremity Stability Test. The initial position of the test is a push-up position with the upper extremities perpendicular to the ground. We will use two strips of 3.80 cm tape stuck on the floor and separated 91.44cm apart. The subjects will carry one of the hands until they touch the other strip of tape and return to the initial position. The touches will be counted every time one of the tape strips is touched in a total time of 15 seconds. Each subject will perform a warm-up, followed by 3 attempts with a break between attempts, of 45 seconds, averaging the 3 data obtained."},{"outcome_type":"secondary","measure":"Change from baseline functionality after treatment and at 1 month","time_frame":"Screening visit, within the first seven days after treatment and after one month follow-up visit","description":"The assessment will be carried out with the Simple Shoulder Test. This test is a questionnaire of 12 questions, with two answer options: yes (when the subject is able to perform the task) and no (when he is not able to do it). The results obtained have a scoring range from 0 to 12, with 0 being the lowest functionality and 12 being the highest."}]}
{"nct_id":"NCT04187014","start_date":"2020-02-06","phase":"Phase 2","enrollment":90,"brief_title":"Oral Tranexamic Acid vs. Oral Aminocaproic Acid to Reduce Blood Loss After Total Hip Replacement","official_title":"Oral Tranexamic Acid vs. Oral Aminocaproic Acid to Reduce Blood Loss, Transfusion Index and Complications After Total Hip Replacement. A Prospective, Randomized, Double Blind Clinical Trial","primary_completion_date":"2021-04-26","study_type":"Interventional","rec_status":"Completed","completion_date":"2021-04-26","last_update":"2021-04-28","description":"This study compares two oral medications (tranexamic acid and aminocaproic acid) as hemostatic agent administered in patients undergoing primary total hip replacement","other_id":"OR19-00003","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","intervention_model_description":"Two study groups will be generated, each consisting of 45 research subjects, randomly each recipient will receive 3 doses of one of the two study drugs (tranexamic acid or aminocaproic acid). The group to which the patient belongs will be assigned through a computer program, the patient will not know to which group he belongs or what medication he will receive. The patients will be extracted from the external traumatology clinic","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":99,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age over 18 years\r\n\r\n          2. Total replacement of the primary hip due to: 1) Primary Coxarthrosis, 2) Avascular hip\r\n             necrosis, 3) Transcervical fracture\r\n\r\n          3. Unilateral procedure\r\n\r\n          4. Press-fit prosthesis\r\n\r\n          5. Without the use of cement for the placement of the prosthesis\r\n\r\n          6. Desire to participate voluntarily in the study and signature of informed consent\r\n\r\n          7. Pre-operative assessment with result between ASA I, ASA II or ASA III performed and\r\n             annexed in the clinical file either by the Department of Internal Medicine, Cardiology\r\n             or Anesthesiology of our hospital.\r\n\r\n          8. Possibility for oral administration of the drug.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. History of thrombotic or embolic event in the last 6 months\r\n\r\n          2. Clinical history of coagulopathy\r\n\r\n          3. Previous surgeries in the hip to intervene\r\n\r\n          4. Patients who have received aspirin, platelet or coumarinic antiplatelet agents in the\r\n             week prior to surgery or NSAIDs two days prior to surgery.\r\n\r\n          5. History of myocardial infarction, arteriopathy or unstable angina in the 12 months\r\n             prior to surgery.\r\n\r\n          6. Those patients whose preoperative assessment corresponds to an ASA IV or the procedure\r\n             is contraindicated in its preoperative assessment.\r\n\r\n          7. Revision hip replacement\r\n\r\n          8. Tumoral hip replacement\r\n\r\n          9. Bilateral hip replacement\r\n\r\n         10. Cognitive deficit\r\n\r\n         11. Patients who meet the inclusion criteria but do not wish to participate in the study\r\n\r\n         12. Patients with a diagnosis of Terminal Chronic Kidney Disease or with a serum\r\n             creatinine higher than 1.47 mg / dl in the preoperative laboratories.\r\n\r\n         13. Patients with inability to ingest the drug orally.\r\n\r\n         14. Patients who are pregnant or breast-feeding or who are taking oral contraceptives.\r\n\r\n         15. Seizure history\r\n\r\n         16. Hypersensitivity to the active substance or to any of the excipients\r\n      ","sponsor":"Carlos A Acosta-Olivo","sponsor_type":"Other","conditions":"Blood Loss, Surgical","interventions":[{"intervention_type":"Drug","name":"Drug: Aminocaproic Acid 1000Mg Tab","description":"Oral administration of a total 6 g of aminocaproic acid to reduce blood loss"},{"intervention_type":"Drug","name":"Drug: Tranexamic acid tablets","description":"Oral administration of 3.9 g of tranexamic acid to reduce blood loss"}],"outcomes":[{"outcome_type":"primary","measure":"Total blood loss (TBL)","time_frame":"The third day postoperative,at the time of obtaining the result of the hematocrit of 72 hours","description":"Total blood loss 72 hours after surgery,The Gross and Nadler formula was used to calculate TBL. TBL = patient's blood volume (PBV) x (Hctpre - Hctpost)/Hctave (Hctpre = the initial pre-operative Hct level, Hctpost = the Hct on the morning of POD3). PBV = k1 x height (m) + k2 x weight (kg) + k3 (k1 = 0.3669, k2 = 0.03219, and k3 = 0.6041 for men; and k1 = 0.3561, k2 = 0.03308, and k3 = 0.1833 for women, Hctave = the average of the Hctpre and Hctpost)"},{"outcome_type":"primary","measure":"External blood loss (EBL)","time_frame":"On the second postoperative day (48 hours), when removing the surgical drainage.]","description":"External blood loss (EBL) was estimated by adding the intraoperative bleeding and the blood in the drain collectors upon removal after 48 hours"},{"outcome_type":"primary","measure":"Hidden blood loss (HBL)","time_frame":"The third day postoperative","description":"Defined as total blood loss minus external blood loss"},{"outcome_type":"secondary","measure":"Change in hematocrit level","time_frame":"Hematocrit levels will be measured at 24, 48 and 72 hours postsurgery","description":"Hematocrit levels obtained in 3 samples taken at different times postsurgery"},{"outcome_type":"secondary","measure":"Drainage quantification","time_frame":"Drainage quantification will be registered at 24 and 48 hours postsurgery","description":"Drainage will be quantified in ml at 2 different times postsurgery"},{"outcome_type":"secondary","measure":"Therapeutic effect on visual analog scale","time_frame":"Pain will be measured at 24, 48 and 72 hours postsurgery","description":"The Visual Analog Scale is a unidimensional measure of pain intensity. The scale is most commonly anchored by \"no pain \" (score of 0) and \"pain as bad as it could be\" or \"worst imaginable pain\" (scale of 10). It will be assessed as a numeric scale from 0 to 10."},{"outcome_type":"secondary","measure":"Change in Hemoglobin level","time_frame":"Hemoglobin levels will be measured at 24, 48 and 72 hours postsurgery","description":"Hemoglobin levels will be obtained in 3 samples taken at different times postsurgery"},{"outcome_type":"secondary","measure":"Rate of complications","time_frame":"at 24, 48 and 72 hours, 7 days, 4 and 6 weeks","description":"Complications related to the surgery or to the administration of the study medication"},{"outcome_type":"secondary","measure":"Rate of transfusion","time_frame":"at 24, 48 and 72 hours, 7 days, 4 and 6 weeks","description":"Need to administer globular packages following the indications of transfusion haemoglobin (Hb) of 8 g/dl in patients free of cardiovascular disease and Hb of 9 g/dl in patients with established cardiovascular disease or cardiovascular risk factors with symptoms of anaemia (defined as bad mental status, palpitation, or shortness of breath not due to other causes). Hb below 10 g/dl in patients with poor clinical tolerance of lower values was also an indication for transfusion. Symptoms of poor clinical tolerance of lower values were signs of hypoxia such as tachycardia, dyspnoea or syncope or drainage of more than 1 l of blood in the first 24 hours"},{"outcome_type":"secondary","measure":"Rate of intraoperative blood loss","time_frame":"Immediately after the end of the surgery","description":"Intra-operative blood loss was calculated using the difference between the weights of the used gauze and the original unused gauze (25 cm x 25 cm, monolayer, weight of 30 grams), in addition to the blood volume accumulated in suction bottles subtracting the volume of saline solution during the surgery"}]}
{"nct_id":"NCT04224597","start_date":"2020-02-01","enrollment":48,"brief_title":"Evaluation of the Presence of Enthesitis in Patients With Acne Vulgaris","official_title":"Evaluation of the Presence of Enthesitis in Patients With Acne Vulgaris","primary_completion_date":"2020-04-01","study_type":"Observational","rec_status":"Not yet recruiting","completion_date":"2020-04-01","last_update":"2020-01-27","description":"Acne vulgaris is an inflammatory disease of the pilosebaceous unit, affecting about 85% of the young population. In the studies p. acne is a potent stimulator of the release of IFN-gamma (IFN-)) and IL-17 from CD4 + T cells, and the presence of IL-17 + cells in the perifollicular infiltrate has been shown in biopsies of inflammatory acne lesions. Therefore, acne is thought to be a Th17-related disease (1). This study was aimed to evaluate the presence of enthesitis in patients with acne vulgaris.","other_id":"Hitit University","observational_model":"Case-Control","time_perspective":"Cross-Sectional","sampling_method":"Probability Sample","gender":"Female","minimum_age":18,"maximum_age":25,"population":"Patients with acne vulgaris and healthy controls aged between 18-25","criteria":"\n        Inclusion Criteira:\r\n\r\n          -  Patients with acne vulgaris and healthy controls aged between 18-25\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Participants with rheumatic and neurologic disease, history of trauma ,\r\n      ","sponsor":"Erol Olcok Corum Training and Research Hospital","sponsor_type":"Other","conditions":"Enthesitis|Acne Vulgaris|Ultrasonography","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: ultrasonography","description":"all participants will be determined by ultrasonography."}],"outcomes":[{"outcome_type":"primary","measure":"patellar tendon thicknesses of patients with acne vulgaris and healthy controls","time_frame":"3 months"},{"outcome_type":"primary","measure":"Ashilles tendon thicknesses of patients with acne vulgaris and healthy controls","time_frame":"3 months"}]}
{"nct_id":"NCT04255524","start_date":"2020-02-01","phase":"N/A","enrollment":200,"brief_title":"Choroidal Change on OCTA in Eyes With High Myopia","official_title":"OCTA to Quantify the Parapapillary Choroidal Microvascular Changes in High Myopia","primary_completion_date":"2030-12-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2030-12-31","last_update":"2020-02-05","description":"Myopia is a global healthy concern, especially the high myopia and pathological myopia among Asian populations. However, its mechanism still remains largely unclear. Recent findings suggested choroidal changes might be related to the development of myopia. This study is to useOCT angiography (OCT-A) to investigate parapapillary choroidal microvasculature change in myopic eyes, and try to find the cause-and-effect relationship between choroidal change and the development of myopia.","other_id":"OCTAPPA","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Spherical equivalent measurement can be included in above 4 groups\r\n\r\n          2. Willing to be followed up in the future 10 years\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Deny to sign the patient consent, or deny to be followed\r\n\r\n          2. Evidence of cardiac, or diabetic, or CNS disease.\r\n\r\n          3. Clinically diagnosed with retinal or choroidal disease\r\n\r\n          4. Glucoma\r\n\r\n          5. Cataract or corneal disease that influence the quality of fundus OCTA image\r\n      ","sponsor":"The First Affiliated Hospital with Nanjing Medical University","sponsor_type":"Other","conditions":"Myopia, Progressive|Choroid Disease","interventions":[{"intervention_type":"Device","name":"Device: Optic coherence tomography angiography (OCTA)","description":"Using non-invasive, repeatable, mature device OCTA to obtain choroidal angio-map"}],"outcomes":[{"outcome_type":"primary","measure":"Parapapillary choroidal microvasculature void (MvV) area","time_frame":"changes of MvV area from at 10 years","description":"area of parapapillary choroidal microvasculature void on OCTA images"},{"outcome_type":"primary","measure":"Parapapillary choroidal microvasculature void (MvV) area","time_frame":"difference of MvV area in each group at baseline","description":"area of parapapillary choroidal microvasculature void on OCTA images"},{"outcome_type":"primary","measure":"Parapapillary choroidal microvasculature void (MvV) area","time_frame":"changes of MvV area at 1 years","description":"area of parapapillary choroidal microvasculature void on OCTA images"},{"outcome_type":"primary","measure":"Parapapillary choroidal microvasculature void (MvV) area","time_frame":"changes of MvV area at 3 years","description":"area of parapapillary choroidal microvasculature void on OCTA images"},{"outcome_type":"primary","measure":"Parapapillary choroidal microvasculature void (MvV) area","time_frame":"changes of MvV area at 5 years","description":"area of parapapillary choroidal microvasculature void on OCTA images"},{"outcome_type":"secondary","measure":"MvV number","time_frame":"baseline","description":"number of choroidal MvV with certain size"},{"outcome_type":"secondary","measure":"Correlation coefficient between choroidal MvV and refractive power","time_frame":"baseline","description":"Correlation coefficient between choroidal MvV and refractive power"},{"outcome_type":"secondary","measure":"Correlation coefficient between choroidal MvV and PPA area","time_frame":"baseline","description":"Correlation coefficient between choroidal MvV and parapapillary atrophy beta area"},{"outcome_type":"secondary","measure":"Correlation coefficient between choroidal MvV and choroid thickness","time_frame":"baseline","description":"Correlation coefficient between choroidal MvV and choroid thickness"},{"outcome_type":"secondary","measure":"Correlation coefficient between choroidal MvV and RNFL thickness","time_frame":"baseline","description":"Correlation coefficient between choroidal MvV and RNFL thickness"},{"outcome_type":"secondary","measure":"Correlation coefficient between choroidal MvV and Axial length","time_frame":"baseline","description":"Correlation coefficient between choroidal MvV and Axial length"},{"outcome_type":"secondary","measure":"Correlation coefficient between choroidal MvV and retinal parapapillary perfusion","time_frame":"baseline","description":"Correlation coefficient between choroidal MvV and retinal parapapillary perfusion on OCTA images."},{"outcome_type":"secondary","measure":"Correlation coefficient between choroidal MvV and Macular perfusion","time_frame":"baseline","description":"Correlation coefficient between choroidal MvV and Macular perfusion on OCTA images, Retinal parapapillary perfusion with OCTA."}]}
{"nct_id":"NCT04336605","start_date":"2020-02-01","enrollment":25000,"brief_title":"Killing Pain - Use of Analgesic, Sedative and Anxiolytic Medication and the Development of Psychiatric Illness in Adolescents","official_title":"Killing Pain - Use of Analgesic, Sedative and Anxiolytic Medication and the Development of Psychiatric Illness in Adolescents","primary_completion_date":"2023-01-31","study_type":"Observational [Patient Registry]","rec_status":"Active, not recruiting","completion_date":"2025-01-31","last_update":"2020-04-09","description":"Prescription of analgesic, sedative, and anxiolytic medication for children and adolescents is increasing in Western countries. In recent decades, rates have also increased in Norway, despite a relatively restrictive prescription practice. Analgesics, sedatives, and anxiolytics are among the medications most commonly prescribed to young people by general practitioners and others. Overuse of such medication adversely impacts individual and societal health, social and economic measures. For example, the risk of chronification of pain, development of addiction, and dropout from school and the workforce is high. Epidemiological research has largely failed to integrate vulnerable, young service users' perspectives in planning, interpretation and dissemination of results. This has resulted in limited identification of potential causes for the increasing exposure to prescription and overuse of analgesics and other addictive drugs among of children and adolescents, and the long-term consequences this may have for morbidity and addiction in early adulthood. Knowledge of early risk factors and plausible causal mechanisms is crucial for the development of timely and effective interventions to prevent inappropriate prescriptions in clinical practice. This prospective, longitudinal cohort study examines the use of analgesic, sedative, and anxiolytic medication among about 25,000 children throughout adolescence and young adulthood (1995 to 2020), specifically addressing changes in prescription over time, and early risk factors for the prescription of addictive drugs in adolescence and young adulthood and the subsequent development of mental health disorders.","other_id":"Killing Pain","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":13,"maximum_age":32,"population":"All youth in Nord-Trndelag county in Norway between 13-19 years were invited to\r\n        participate in the four Young-HUNT study waves (1995-2019), and followed up after\r\n        approximately 10 years between 2017-2020. In this study data from the Young-HUNT1-4 studies\r\n        (1995-2019) will be linked to longitudinal, individual data from the Norwegian prescription\r\n        Database (NorPD) (2004-2020), providing a unique, longitudinal dataset. To obtain good,\r\n        reliable followup data for the young-HUNT3 participants (2006-2008) the investigators will\r\n        additionally include longitudinal data of for those participating in both the YoungHUNT3\r\n        and the YoungHUNT4 (2017-2019).","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  All youth in Nord-Trndelag county were invited to participate in four subsequent\r\n             Young-HUNT study waves (1995-2019), https://www.ntnu.edu/hunt/young-hunt\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  None\r\n      ","sponsor":"Norwegian Center for Violence and Traumatic Stress Studies","sponsor_type":"Other","conditions":"PTSD|Psychiatric Illness|Prescription Drug Dependence|Addiction","interventions":[{"intervention_type":"Other","name":"Other: Age & Development","description":"Age, sex, pubertal onset and development"},{"intervention_type":"Other","name":"Other: Socioeconomy","description":"Family structure and economy"},{"intervention_type":"Other","name":"Other: Traumatic Events","description":"Violence and other traumatic events"},{"intervention_type":"Other","name":"Other: Psychosocial conditions","description":"Family/social support"},{"intervention_type":"Other","name":"Other: Lifestyle","description":"Physical activity, BMI, nutrition, smoking "},{"intervention_type":"Other","name":"Other: Chronic conditions","description":"I.e. Epilepsy or juvenile rheumatoid arthritis ..."},{"intervention_type":"Other","name":"Other: Somatic symptoms","description":"Headache, pain, sleep disturbances ..."},{"intervention_type":"Other","name":"Other: Psychological symptoms","description":"PTSS, anxiety, depressive symptoms & loneliness ..."},{"intervention_type":"Other","name":"Other: Non-prescription analgesics","description":"Non-prescription analgesics"},{"intervention_type":"Other","name":"Other: Prescription drugs","description":"Analgetic, sedative & anxiolytic medication"}],"outcomes":[{"outcome_type":"primary","measure":"Prescription drugs","time_frame":"2006-2020","description":"Analgetic, sedative & anxiolytic medication"},{"outcome_type":"primary","measure":"Psychiatric Illness","time_frame":"2006-2020","description":"Medically treated severe mental illness, i.e. depression, psychosis, dependency or addiction disorders"}]}
{"nct_id":"NCT04218669","start_date":"2020-02-01","phase":"N/A","enrollment":105,"brief_title":"The Approach of Biliary Drainage in Hepatolithiasis Patients With Sphincter of Oddi Laxity","official_title":"A Clinical Randomized Trial Comparing T-tube Drainage Versus Choledochojejunostomy in Hepatolithiasis Patients With Sphincter of Oddi Laxity","primary_completion_date":"2025-09-30","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2025-12-30","last_update":"2020-01-06","description":"Residual and recurrent stones remain one of the most important challenges of hepatolithiasis which is reported in 20% to 50% of patients treated with these therapies. Up to now the most two common surgical procedures performed were choledochojejunostomy and T tube drainage as biliary drainage in hepatolithiasis. The goal of the present study was to evaluate the therapeutic safety, and perioperative and long-term outcomes of choledochojejunostomy versus T tube drainage for hepatolithiasis with sphincter of Oddi laxity.","other_id":"1804h08020239","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","intervention_model_description":"Patients were randomized to choledochojejunostomy arm or T tube drainage arm","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age age between 18 and 70 years\r\n\r\n          2. Diagnosed as hepatolithiasis with sphincter of oddi laxity during operation\r\n\r\n          3. Achieved removing the focus, extraction of stones and correction of stricture during\r\n             the operation\r\n\r\n          4. Written Informed consent\r\n\r\n          5. Willingness for complete 3-year follow-up.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Participation in concurrent intervention trials with interference of outcome of this\r\n             study\r\n\r\n          2. Associated tumor\r\n\r\n          3. Diagnosed as sphincter of oddi complete loss of function or normal\r\n\r\n          4. Underwent choledochojejunostomy at past\r\n\r\n          5. Lack of compliance\r\n      ","sponsor":"xpgeng","sponsor_type":"Other","conditions":"Sphincter of Oddi Laxity","interventions":[{"intervention_type":"Procedure","name":"Procedure: Roux-en-Y Hepaticojejunostomy","description":"The common hepatic duct was cut and the duodenal side is closed by suture. The small intestine was cut off 15 cm below the ligament of Treitz. The distal end was lifted, and a 1-2 cm incision was made at the jejunal wall 4-5 cm from the jejunal stump. The anastomosis is used a 5-0 PSD  suture, with double needles, inside-out in the jejunum and outside-in in the hepatic duct. One side of needles was used to continuely penetrate and suture the whole layer of the posterior-lateral wall of the jejunum, the posterior-lateral wall of the biliary duct, and the other side of needles was used to continuely stuere the anterior part of the anastomosis. Mucosa-to-mucosa contact should be ensured with every stitch.The anastomotic stomas were then checked for leakage. Enteric-enteric anastomosis was performed 60 cm below the site of the hepatojejunal anastomosis."},{"intervention_type":"Procedure","name":"Procedure: T-tube drainage","description":"The T-tube was placed for biliary drainage and the common bile duct was intermittently sutured with 4-0 vicryl sutures."}],"outcomes":[{"outcome_type":"primary","measure":"stone recurrence rate","time_frame":"3 years","description":"A recurrence stone was defined as a stone detected more than 3 months after surgery by any diagnostic method. (%)"},{"outcome_type":"primary","measure":"biliary stricturer rate","time_frame":"3 years","description":"Biliary stricture defined as clinically evident stenosis and subclinical stenosis proved by endoscopic examination or reoperation (%)"},{"outcome_type":"primary","measure":"Cholangitis rate","time_frame":"3 years","description":"The diagnosis of cholangitis is based on clinically evident (abdominal discomfort/pain, jaundice or fever associated with hepatolithiasis (%)"},{"outcome_type":"secondary","measure":"sphincter of oddi function","time_frame":"an expected average of 120 minutes","description":"Grading criteria for the SO function were as follows: Normal; Laxity and Loss of function"},{"outcome_type":"secondary","measure":"Mortality","time_frame":"90 days","description":"Operative mortality was defined as any death resulting from a complication during surgery"},{"outcome_type":"secondary","measure":"Biliary leakage","time_frame":"90 days","description":"Biliary leakage was documented in line with the International Study Group of Liver Surgery (ISGLS) definitions and grading systems"},{"outcome_type":"secondary","measure":"total bilirubin","time_frame":"90 days","description":"serum total bilirubin on 3 postoperative day (umol/L)"},{"outcome_type":"secondary","measure":"quality of life grading","time_frame":"3 years","description":"Quality of life will be assessed by Visick score (Ⅰ～Ⅳ)."}]}
{"nct_id":"NCT04409613","start_date":"2020-02-01","phase":"N/A","enrollment":59,"brief_title":"Cost-Effectiveness Study on Establishing a Warfarin Counseling Clinic for Egyptian Patients With Mitral Valve Prostheses","official_title":"Cost-Effectiveness Study on Establishing a Warfarin Counseling Clinic for Egyptian Patients With Mitral Valve Prostheses","primary_completion_date":"2021-03-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2021-03-01","last_update":"2021-07-21","description":"The outcome of poor adherence to medications can be life threatening with certain drugs like warfarin. For each 10% increase in non-adherence to warfarin, there was a 14% increase in the risk of under-anticoagulation with significantly higher rates of morbidity and mortality. Furthermore, warfarin therapy is fraught with several inherent problems. These include a wide variation in dose requirement, delayed onset of anticoagulant effect, prolonged continuation after cessation of therapy, serious interactions with a wide range of medications and food items, risk of major hemorrhage related to overdosing, unpredictable control in presence of co-morbidities such as hepatic and renal impairment. There is ongoing evidence that better outcomes are achieved when anticoagulation is managed by a pharmacist with expertise in anticoagulation management rather than usual care by physicians. Pharmacists can contribute to positive outcomes of therapy by educating and counseling patients to prepare and motivate them to follow their therapeutic regimens and monitoring plans, which will result substantially in improving the quality of care, reducing complications, and lowering hospitalization rates. Thus, beneficial effects of the pharmacist-managed counseling clinic have been repeatedly reported in terms of cost-effectiveness, patients' adherence to and knowledge about pharmacotherapy, and the outcome of treatment. The objective of this study is to evaluate the cost-effectiveness of establishing a Medication Counseling Clinic for outpatients with mitral valve prostheses taking warfarin therapy in an Egyptian Teaching Hospital setting. Availability of this information could be used to target further quality improvement efforts, which may significantly improve outcomes for patients and cost containment efforts in an era when cost-effectiveness is at the forefront of healthcare policy initiatives.","other_id":"ENREC-ASU.2019-99","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Adult patients (18-70) years.\r\n\r\n          2. Post mitral valve surgery patients.\r\n\r\n          3. Patients with a prescription of warfarin.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Pregnant patients.\r\n\r\n          2. Patients with double and aortic valve replacement surgery.\r\n\r\n          3. Patients with biological prostheses.\r\n\r\n          4. Patients with congenital blood disorders.\r\n      ","sponsor":"Ain Shams University","sponsor_type":"Other","conditions":"Cost Effectiveness","interventions":[{"intervention_type":"Other","name":"Other: Education and counseling","description":"All patients or their caregivers will receive twenty minutes educational sessions for the first three visits according to patient ability to understand. At subsequent visits along the study duration, we will briefly review our educational material to refresh the patient's information. This will include: The objectives of treatment, disease progression process, risk factors, common symptoms of bleeding/thrombotic events and how to deal with this. Lifestyle modifications, including smoking cessation, blood pressure and diabetes control. Drug information: drug action, dose, indication, possible side effects, how to deal with the side effects, actions to take when missing the dose, storage conditions and when and how to administer. Possible interactions including drug-drug and drug-food interactions. Target INR and INR monitoring"}],"outcomes":[{"outcome_type":"primary","measure":"Quality-adjusted life-years (QALYs)","time_frame":"1 year","description":"The outcome of the two strategies will be measured in terms of quality-adjusted life-years (QALYs).This measurement weighs the length of life by the quality of life a patient experiences while in a specific health state. QALYs combine both morbidity and mortality into a single parameter."}]}
{"nct_id":"NCT04424576","start_date":"2020-01-31","enrollment":60,"brief_title":"Ovarian Morphology in Girls","official_title":"Trajectory of Ovarian Morphology During the Adolescent Reproductive Transition","primary_completion_date":"2022-12-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2022-12-31","last_update":"2020-12-04","description":"Establishment of regular menstrual cycles is a key component of reproductive maturation and a recognized vital sign for health and well-being. Irregular menstrual cycles are especially common for the first 2-3 years after an adolescent's first menstrual period (i.e., menarche), which delays the identification and diagnosis of early reproductive disturbances such as polycystic ovary syndrome (PCOS). The purpose of this research study is to determine whether the ovary can serve as a reliable predictor of normal or abnormal development by following the trajectory of ovarian morphology in conjunction with menstrual cyclicity using 3D transabdominal ultrasound imaging in a prospective cohort study of adolescents. A secondary objective is to identify potential environmental factors such as diet and the gut microbiome which influence the trajectory towards normal or abnormal reproductive development.","other_id":"IRB# 0000779","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"Female","minimum_age":9,"maximum_age":17,"population":"Female adolescents between the ages of 9 and 17 years who achieved menarche (i.e., very\r\n        first period) within the past 11 months will be recruited.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Female adolescents aged 9 to 17 years\r\n\r\n          -  Menarche within 11 months of the enrollment visit\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Current or recent use of medications or supplements known or suspected to interfere\r\n             with reproductive or metabolic function in the past 2 months (e.g., contraceptives,\r\n             metformin, steroids, anti-seizure medications)\r\n\r\n          -  Untreated and/or unstable medical or mental health condition known or suspected to\r\n             interfere with reproductive or metabolic function\r\n\r\n          -  Currently pregnant or breast feeding\r\n\r\n          -  History of ovarian surgery\r\n\r\n          -  Presence of significant acute or chronic illness which may interfere with study\r\n             participation\r\n      ","sponsor":"Cornell University","sponsor_type":"Other","conditions":"Amenorrhea|Oligomenorrhea|Puberty","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Ovarian size","time_frame":"24 months","description":"Changes in ovarian size over the first 2y post-menarche will be assessed and compared across cohorts."},{"outcome_type":"primary","measure":"Follicle counts","time_frame":"24 months","description":"Follicle counts, expressed as follicle number per ovary (FNPO) and follicle number per cross-section (FNPS), will be assessed over the first 2y post-menarche and compared across cohorts. Numbers of large follicles (>10 mm diameter) and small follicles (<10 mm diameter) will also be compared across cohorts."},{"outcome_type":"primary","measure":"Menstrual cycle status","time_frame":"24 months","description":"Menstrual cycle status (i.e., regular versus irregular menstrual cycles) will be assessed using menstrual cycle records maintained by participants over the course of the study. Changes in menstrual cycle status over the 2y post-menarche and relationships between menstrual cycle status and other physiological and lifestyle factors will be examined."},{"outcome_type":"secondary","measure":"Body composition","time_frame":"24 months","description":"Changes in percent body fat, obtained using a bioimpedence scale, will be assessed over the first 2y post-menarche and compared across cohorts."},{"outcome_type":"secondary","measure":"Leutenizing hormone (LH), follicle stimulating hormone (FSH), estradiol, progesterone, anti-mullerian hormone, free and total testosterone, and androstenedione","time_frame":"24 months","description":"Serum levels of these reproductive hormones will be assessed over the first 2y post-menarche and compared across cohorts."},{"outcome_type":"secondary","measure":"Sleep quality","time_frame":"24 months","description":"Sleep quality will be assessed using two questionnaires: the Morningness-Eveningness Scale for Children and the Children's Report of Sleep Patterns. Sleep quality will be assessed over the first 2y post-menarche and compared across cohorts."},{"outcome_type":"secondary","measure":"Dietary composition","time_frame":"24 months","description":"Dietary composition (i.e., macro and micronutrient totals, total energy intake) will be assessed using two 24-Hour Food Frequency Questionnaires administered at each gynecological time point."},{"outcome_type":"secondary","measure":"Gut microbiome richness and diversity","time_frame":"24 months","description":"Gut microbiome richness and diversity will be assessed over the first 2y post-menarche and compared across cohorts."}]}
{"nct_id":"NCT04115397","start_date":"2020-01-31","phase":"Phase 4","enrollment":80,"brief_title":"Bisphosphonates for the Treatment of Seropositive Musculoskeletal Complaints","official_title":"Towards Efficient Prediction and Prevention of Rheumatoid Arthritis","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2022-12-31","last_update":"2019-10-04","description":"Seropositive Rheumatoid arthritis (RA) is characterized by autoantibodies that develop prior to clinical onset, allowing identification of individuals at risk for disease development. In a unique program in Stockholm, seropositive individuals presenting with musculoskeletal complains are currently identified and followed-up in a dedicated outpatient clinical program. Despite significant disease burden and increased sick leave among these individuals, we lack today any therapeutic and preventive measures. We aim to (1). establish a nation-wide health program, (2). develop an algorithm for disease risk estimation and (3). test a novel strategy to delay and/or prevent disease onset in seropositive at risk individuals with musculoskeletal complains. We will perform a multicentre randomised study to treat autoantibody-positive individuals at risk for developing RA presenting with pain (Population), by repurposing of bisphosphonates (Intervention) as compared to placebo (Control) to treat pain (primary Outcome) and delay/prevent RA development during 1-year follow-up (secondary Outcome)","other_id":"2018/682-31","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Age older than 18 years Lack of arthritis as estimated by clinical and ultrasound\r\n        examination of the joints ACPA positive Intermediate or high risk for RA (according to the\r\n        algorithm described above) VAS score of at least 20 mm\r\n\r\n        Exclusion Criteria:\r\n\r\n        A previous diagnosis of arthritis Intolerance/contraindication to any of the study\r\n        medications\r\n      ","sponsor":"Karolinska Institutet","sponsor_type":"Other","conditions":"Seropositive Muskuloskeletal Complaints","interventions":[{"intervention_type":"Drug","name":"Drug: Zoledronic Acid","description":"Treating seropositive individuals with musculoskeletal symptoms with one infusion zolendronic acid as compared to placebo"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"VAS pain","time_frame":"3 months","description":"PAin on a visual analogue scale"},{"outcome_type":"secondary","measure":"HAQ","time_frame":"3 months","description":"Health assessment questionnaire"},{"outcome_type":"secondary","measure":"MRI","time_frame":"6 months","description":"MRI investigation of the symptomatic joints in the hands"},{"outcome_type":"secondary","measure":"Rheumatoid Arthritis (RA ) diagnosis","time_frame":"1 year","description":"Getting a diagnosis of RA"}]}
{"nct_id":"NCT04497064","start_date":"2020-01-30","enrollment":585,"brief_title":"Breakfast Knowledge, Beliefs, and Habits of Exercising Adults","official_title":"Breakfast Knowledge, Beliefs, and Habits of Exercising Adults","primary_completion_date":"2020-03-24","study_type":"Observational","rec_status":"Completed","completion_date":"2020-03-24","last_update":"2021-02-24","description":"This study is being done to determine typical breakfast consumption habits in various populations of exercisers. Participants will be asked a series of questions pertaining to their participation in regular exercise, their current breakfast consumption, food preferences, meal timing, and general knowledge of sports nutrition and pre-exercise breakfast consumption.","other_id":"19-E-364","observational_model":"Ecologic or Community","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"anyone with a valid Ohio University email address or who saw the advertisement on social\r\n        media who was older than 18 and participates in structured exercise","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18+ years old\r\n\r\n          -  regular exerciser\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  younger than 18 years old\r\n\r\n          -  do not regularly exercise\r\n      ","sponsor":"Ohio University","sponsor_type":"Other","conditions":"Nutrition","interventions":[{"intervention_type":"Other","name":"Other: survey","description":"survey asking questions regarding breakfast habits and composition, sports nutrition knowledge and exercise habits"}],"outcomes":[{"outcome_type":"primary","measure":"breakfast composition","time_frame":"Day 1","description":"Questions asked include typical composition of breakfast, such as Meat, Plant-based protein (beans, lentils, peas), Nuts or seeds, Cheese, Eggs, Yogurt or dairy, Bread, Starchy vegetables, Non-starchy vegetables, Grains, Fruit/fruit juice, or Protein/meal replacement bars"},{"outcome_type":"primary","measure":"breakfast habits","time_frame":"Day 1","description":"questions regarding typical breakfast consumption habits"},{"outcome_type":"primary","measure":"breakfast beliefs","time_frame":"Day 1","description":"questions regarding how individuals felt about eating breakfast"},{"outcome_type":"primary","measure":"sports nutrition knowledge","time_frame":"Day 1","description":"questions from the 49-SNKI to assess sports nutrition knowledge"},{"outcome_type":"primary","measure":"exercise habits","time_frame":"Day 1","description":"questions on frequency, duration and intensity of typical exercise sessions"}]}
{"nct_id":"NCT03892785","start_date":"2020-01-27","phase":"Phase 3","enrollment":200,"brief_title":"MEthotrexate Versus TOcilizumab for Treatment of GIant Cell Arteritis: a Multicenter, Randomized, Controlled Trial","official_title":"MEthotrexate Versus TOcilizumab for Treatment of GIant Cell Arteritis: a Multicenter, Randomized, Controlled Trial","primary_completion_date":"2025-01-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2026-03-31","last_update":"2021-05-04","description":"Giant-cell arteritis (GCA) is the most frequent vasculitis after 50 years. It is characterized by a granulomatous inflammation of the wall of large vessels, involving especially the aorta and extra-cranial branches of the external carotid, with vascular remodelling leading to ischemic manifestations such as temporal headaches, jaw claudication, scalp tenderness and visual loss. Most patients with GCA also present signs of systemic inflammation, including weight loss, fatigue and fever, together with an increased erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) level. Glucocorticoids (GC) are the cornerstone of the treatment of GCA. They are very effective and are usually given for 18-24 months to avoid relapses. Therefore, most patients develop GC-related complications that cause morbidity and disability. GC sparing strategies are thus required to improve the treatment of GCA. - A 12-month treatment with tocilizumab (TCZ) has recently been shown to be effective in inducing and maintaining remission of GCA, with a dramatic GC-sparing effect. However, TCZ is an expensive drug; TCZ suppresses CRP synthesis and ESR elevation so that it is difficult to monitor patients; and importantly around 40% of patients relapse within 6 months after TCZ discontinuation, whether prescribed for 12 months or 4 months. - In association with 6 months of prednisone, 10 mg/week of methotrexate (MTX) for 24 months lowers the risk of relapse at 24 months from 84% to 45%. Therefore, the hypothesis is that 12 months of MTX treatment (0.3 mg/Kg/week, without exceeding 20 mg/week) is not inferior to 12 months of TCZ (162 mg SC/week) in term of prevention of relapse at 18 months. The MTX strategy might be more cost effective than TCZ. In the present study, it is proposed to compare MTX versus TCZ in a multicenter randomized controlled trial. Moreover, the economic consequences associated with the use of MTX rather than TCZ will be also assess.","other_id":"BONNOTTE PHRC N 2017","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Written consent\r\n\r\n          -  Affiliation to a social security system\r\n\r\n          -  Diagnosis of GCA, as defined by the revised GCA diagnosis criteria:44\r\n\r\n               -  Age 50 years at disease onset\r\n\r\n               -  AND History of erythrocyte sedimentation rate (ESR) 50 mm/h OR CRP20 mg/L (not\r\n                  mandatory if TAB is positive: see below)\r\n\r\n               -  AND At least one of the following:\r\n\r\n          -  unequivocal cranial symptoms of GCA (new onset headache, scalp tenderness, jaw\r\n             claudication, temporal artery abnormality, ischemia-related vision loss)\r\n\r\n          -  unequivocal symptoms of polymyalgia rheumatica (PMR)\r\n\r\n             o AND At least one of the following:\r\n\r\n          -  Temporal artery biopsy (TAB) compatible with the diagnosis of GCA (non-necrotizing\r\n             vasculitis with a predominance of mononuclear cell infiltration or granulomatous\r\n             inflammation, usually with multinucleated giant cells)\r\n\r\n          -  Evidence of large vessel vasculitis (aorta and/or epiaortic arteries):\r\n\r\n               -  angio-CT or angio-MRI: thickened arterial wall (2mm for the aorta and 1mm for\r\n                  epiaortic arteries) and/or contrast-enhanced arteries in T1-weighted sequences\r\n\r\n               -  PET scan: grade 3 tracer uptake of the arterial wall (grade 3 = arterial SUVmax\r\n                  superior to the SUVmax of the liver)\r\n\r\n          -  Active GCA within 6 weeks before randomization. Active GCA is defined by ESR 30 mm/h\r\n             or CRP 10 mg/L and at least one of the following:\r\n\r\n               -  1 unequivocal cranial symptom(s) of GCA (new onset localized headache, scalp or\r\n                  temporal artery tenderness, ischemia-related vision loss, or otherwise\r\n                  unexplained mouth or jaw pain upon mastication)\r\n\r\n               -  1 unequivocal symptom(s) of PMR, defined as shoulder and/or hip girdle pain\r\n                  associated with inflammatory stiffness\r\n\r\n               -  any other feature(s) judged by the clinical investigator to be consistent with\r\n                  GCA or PMR flares\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Uncontrolled psychotic state\r\n\r\n          -  Patient unable to give his/her consent\r\n\r\n          -  Premenopausal women (menopause is defined as amenorrhea for more than 12 consecutive\r\n             months)\r\n\r\n          -  Non-compliant patients\r\n\r\n          -  Weight<40 Kg or >100Kg\r\n\r\n          -  Patients under maintenance of justice, wardship or legal guardianship\r\n\r\n          -  History of intoxication (alcohol or medication) requiring hospitalization within 12\r\n             months before inclusion\r\n\r\n          -  Current chronic alcohol abuse (consumption > 20g/day)\r\n\r\n          -  Recent or incoming surgery within 12 months after inclusion\r\n\r\n          -  History of stem cell or organ transplantation (except corneas performed more than 3\r\n             months prior inclusion)\r\n\r\n          -  Primary or secondary immunodeficiency\r\n\r\n          -  Hypersensitivity to methotrexate or tocilizumab, one of its excipients or another\r\n             human or murine monoclonal antibody\r\n\r\n          -  History of diverticulitis, inflammatory bowel disease, or other symptomatic\r\n             gastrointestinal tract condition that might predispose to bowel perforation\r\n\r\n          -  Patient refusing to sign methotrexate safety contract\r\n\r\n          -  Prior treatment with any of the following:\r\n\r\n               -  Tocilizumab or methotrexate within 12 weeks before inclusion\r\n\r\n               -  Treatment with rituximab or other anti-CD20 agent within one year before\r\n                  inclusion\r\n\r\n               -  Treatment with cyclophosphamide within one year before inclusion\r\n\r\n               -  Hydroxychloroquine, cyclosporine A, dapsone, azathioprine, mycophenolate mofetil\r\n                  or janus kinase inhibitors within 4 weeks before inclusion\r\n\r\n               -  Tumor necrosis factor inhibitors within 8 weeks (infliximab) or 2 weeks\r\n                  (adalimumab or etanercept) before inclusion\r\n\r\n               -  Anakinra within 1 week before inclusion\r\n\r\n          -  Long-term systemic glucocorticoid therapy ((except dermocorticoids and inhaled\r\n             corticoids) for other conditions than GCA or PMR\r\n\r\n          -  Patient with 3 prior glucocorticoid systematic therapies for another disease than GCA\r\n             or PMR within the 6 months before inclusion\r\n\r\n          -  Long-term treatment with sulfamethoxazole/trimethoprim (Bactrim)\r\n\r\n          -  Live vaccine administered within 30 days before inclusion\r\n\r\n          -  Laboratory abnormalities:\r\n\r\n               -  AST or ALT >1.5 x upper limit of normal (ULN)\r\n\r\n               -  total bilirubin >ULN\r\n\r\n               -  platelets<100 G/L\r\n\r\n               -  leukocytes <3 G/L\r\n\r\n               -  neutropenia <1.5 G/L\r\n\r\n               -  lymphopenia <0.5 G/L\r\n\r\n               -  haemoglobin <8 g/dL (not related to GCA activity)\r\n\r\n               -  clearance of creatinine <30 ml/min/1,73 m2 [CKD EPI 2009]\r\n\r\n               -  positive HBs antigen or positive HCV antibodies\r\n\r\n          -  Infections:\r\n\r\n               -  History of viral hepatitis B or C (chronic or acute)\r\n\r\n               -  HIV infection\r\n\r\n               -  Persistent infection or severe infection requiring hospitalization or intravenous\r\n                  antibiotics within 30 days before inclusion (antibiotic treatment tests are\r\n                  allowed, regardless of duration and route of administration)\r\n\r\n               -  Proven infection requiring oral antibiotics within 14 days before inclusion\r\n                  (antibiotic treatment tests are allowed, regardless of duration and route of\r\n                  administration)\r\n\r\n               -  Prior history of histoplasmosis or listeriosis\r\n\r\n               -  Active tuberculosis\r\n\r\n               -  Latent tuberculosis (diagnosis based on history of non-treated contact, opacity\r\n                  with a diameter greater than 1 cm on chest radiography, or positive in vitro\r\n                  test: Quantiferon Gold or T-Spot-TB).\r\n\r\n        NB: a history of tuberculosis for which treatment is over and was correctly precribed\r\n        regarding usual recommendations is not an exclusion criteria, whatever the results of\r\n        Quantiferon Gold or T-Spot-TB tests.\r\n\r\n        - Unstable or poorly controlled, acute or chronic disease, not due to GCA, and which\r\n        contraindicates tocilizumab or methotrexate:\r\n\r\n          -  Recurrent infections, unstable ischemic heart disease, renal failure (creatinine\r\n             clearance <30 ml/min/1,73 m2 [CKD EPI 2009]), liver failure, current liver disease,\r\n             heart failure  NYHA stage III/IV, respiratory failure\r\n\r\n          -  Neoplasia < 5 years, (except for in situ cervical cancer and skin carcinoma, except\r\n             melanoma, with R0 resection)\r\n      ","sponsor":"Centre Hospitalier Universitaire Dijon","sponsor_type":"Other","conditions":"Giant Cell Arteritis","interventions":[{"intervention_type":"Drug","name":"Drug: Prednisone treatment","description":"tapering prednisone regimen"},{"intervention_type":"Drug","name":"Drug: Tocilizumab treatment","description":"Tocilizumab 162 mg/week subcutaneous from W0 to W51 (52 injections)"},{"intervention_type":"Drug","name":"Drug: Methotrexate treatment","description":"Methotrexate subcutaneous from W0 to W51 (52 administrations).\r\nW0: 7.5 mg/week\r\nW1: 0.2 mg/Kg/week\r\nW2 to W51: 0.3 mg/Kg/week (without exceeding 20 mg/week) Folic acid 10 mg/week, 48h after taking Methotrexate, from W0 to W51"},{"intervention_type":"Other","name":"Other: Questionnaires","description":"HAQ, SF-36, FACIT-fatigue"},{"intervention_type":"Biological","name":"Biological: Blood samples","description":"Additionnal blood samples for immunomonitoring"}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of patients alive without relapse after initial remission or deviation from the scheduled regimen of prednisone","time_frame":"Week 78"}]}
{"nct_id":"NCT03710122","start_date":"2020-01-23","phase":"Phase 2/Phase 3","enrollment":102,"brief_title":"Vancomycin for Primary Sclerosing Cholangitis","official_title":"A Prospective, Randomized, Multi-centered, Placebo-controlled Clinical Trial of Oral Vanycomycin in Adults With Primary Sclerosing Cholangitis","primary_completion_date":"2022-05-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-11-30","last_update":"2021-07-12","description":"To find out if vancomycin is a safe and effective therapy for primary sclerosing cholangitis. Funding Source - FDA OOPD","eudract_num":"FD-R-6102","other_id":"IND133287","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Male or female subject age 18-75 years\r\n\r\n          2. Diagnosis of PSC consistent with the guidelines published by the American Association\r\n             for the Study of Liver Diseases (AASLD). All subjects must have an elevated serum ALP\r\n             of at least 1.5 times upper limit of normal at baseline plus cholangiographic evidence\r\n             of PSC, as demonstrated by magnetic resonance imaging, endoscopic retrograde\r\n             cholangiography, direct cholangiography or liver biopsy.\r\n\r\n          3. An ultrasound (or equivalent imaging modality) that excludes biliary obstruction and\r\n             malignancy within 6 months of study entry.\r\n\r\n          4. If a patient is on any of the following medications and/or supplements, he or she is\r\n             expected to remain on the same daily dose through the treatment period: UDCA,\r\n             azathioprine, prednisone (or an equivalent steroid compound), methotrexate, a\r\n             5-aminosalicylic acid, biologic therapy, and/or a probiotic.\r\n\r\n          5. PSC with or without inflammatory bowel disease, such as ulcerative colitis or Crohn's\r\n             disease.\r\n\r\n          6. Must agree to comply with the study protocol and provide informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n        1. Administration of an antibiotic within 3 months prior to the study 2. Pregnancy or\r\n        attempting to become pregnant or breastfeeding 3. Presence of any of the following:\r\n\r\n          1. Hepatitis B infection\r\n\r\n          2. Hepatitis C infection (antibody positive); patients with a history of hepatitis C\r\n             infection will be eligible for this study if they have undetectable levels of HCV RNA\r\n\r\n          3. Other cholestatic liver diseases such as primary biliary cholangitis and cholestatic\r\n             diseases of pregnancy\r\n\r\n          4. Metabolic liver diseases such as Wilson's disease and hemochromatosis\r\n\r\n          5. Inherited diseases of the liver such as -1 antitrypsin deficiency\r\n\r\n          6. Immunoglobulin G4-related cholangitis\r\n\r\n          7. PSC with concomitant autoimmune hepatitis (AIH) &/or primary biliary cholangitis\r\n             (previously known as primary biliary cirrhosis)\r\n\r\n          8. Secondary sclerosing cholangitis (SSC)\r\n\r\n          9. Active acute ascending cholangitis requiring antibiotics\r\n\r\n         10. CCA (malignant biliary stricture, neoplasm, & cytology/histopathology or positive\r\n             fluorescence in situ hybridization (FISH) consistent with adenocarcinoma of the bile\r\n             duct)\r\n\r\n         11. A liver biopsy, if one has been previously obtained, which showed non-alcoholic\r\n             steatohepatitis (NASH). Patients with suspected fatty liver imaging will not be\r\n             excluded\r\n\r\n         12. Presence of complications of advanced PSC such as hepatic encephalopathy, portal\r\n             hypertension, hepato-renal syndrome and hepato-pulmonary syndrome\r\n\r\n         13. History of liver transplantation, anticipated need for liver transplantation within 12\r\n             months from randomization, or a Model of End Stage Liver Disease (MELD) score of 15\r\n\r\n         14. Ongoing alcohol abuse (>4 drinks per day for men, and >2 drinks per day for women)\r\n\r\n         15. History of allergic reaction to vancomycin\r\n\r\n         16. Moderate-to-severe renal impairment with a calculated creatinine clearance of\r\n             <60mL/min\r\n\r\n        r. HIV/AIDS q. Any other conditions or abnormalities that, in that opinion of the\r\n        investigator, may compromise the safety of the subject or interfere with the subject\r\n        participating in or completing the study\r\n      ","sponsor":"Elizabeth Carey","sponsor_type":"Other","conditions":"Primary Sclerosing Cholangitis","interventions":[{"intervention_type":"Drug","name":"Drug: Vancomycin","description":"Firvanq by Cutis Pharma"},{"intervention_type":"Other","name":"Other: Placebo","description":"Placebo for Vancomycin"}],"outcomes":[{"outcome_type":"primary","measure":"Alkaline phosphatase at 6 months","time_frame":"6 months","description":"Determine if OV normalizes serum ALP in adults with PSC. Levels of serum ALP obtained at 6 months of OV treatment, and will be compared to those obtained at baseline (month 0), and with values at the same study time points in the placebo arm."},{"outcome_type":"primary","measure":"Alkaline phosphatase at 12 months","time_frame":"12 months","description":"Determine if OV normalizes serum ALP in adults with PSC. Levels of serum ALP obtained at 12 months of OV treatment, and will be compared to those obtained at baseline (month 0), and with values at the same study time points in the placebo arm."},{"outcome_type":"primary","measure":"Alkaline phosphatase at 18 months","time_frame":"18 months","description":"Determine if OV normalizes serum ALP in adults with PSC. Levels of serum ALP obtained at 18 months of OV treatment, and will be compared to those obtained at baseline (month 0), and with values at the same study time points in the placebo arm."},{"outcome_type":"primary","measure":"Alkaline phosphatase at 3 months post treatment = 21 months","time_frame":"21 months","description":"Determine if OV normalizes serum ALP in adults with PSC. Levels of serum ALP obtained at 3 months post OV treatment, and will be compared to those obtained at baseline (month 0), and with values at the same study time points in the placebo arm."},{"outcome_type":"primary","measure":"Alkaline phosphatase at 6 months post treatment = 24 months","time_frame":"24 months","description":"Determine if OV normalizes serum ALP in adults with PSC. Levels of serum ALP obtained at 6 months post OV treatment, and will be compared to those obtained at baseline (month 0), and with values at the same study time points in the placebo arm."},{"outcome_type":"secondary","measure":"Fibroscan, cholangiography","time_frame":"18 months","description":"Transient elastography (TE), a new technique that allows non-invasive assessment and follow up of liver fibrosis by measuring liver stiffness, differentiates between severe from non-severe fibrosis in PSC, and the rate of progression of liver stiffness measurement (LSM) assessed by TE correlates well with the rate of progression of fibrosis in PSC and with patients' clinical outcomes."}]}
{"nct_id":"NCT04035447","start_date":"2020-01-22","phase":"N/A","enrollment":120,"brief_title":"Symptom Management for YA Cancer Survivors","official_title":"Improving Symptom Management for Survivors of Young Adult Cancer","primary_completion_date":"2025-10-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2025-10-01","last_update":"2021-09-16","description":"Symptom interference is common for survivors of young adult cancer (aged 18-39 at diagnosis) and impacts their abilities to achieve normative life goals (e.g., education, careers, independence, romantic/social relationships) as well as adhere to recommended follow-up care. Assistance with symptom management has been rated by young adult survivors as an important and unmet healthcare need; however, skill-based symptom management interventions have typically been tested among older cancer survivors and have not targeted the unique developmental needs of those diagnosed as young adults. The proposed research advances the health and wellbeing of young adult cancer survivors by creating a developmentally appropriate hybrid in-person/mHealth behavioral symptom management intervention which addresses variables (i.e., symptoms and symptom interference) consistently linked to significant social, economic, and health burden.","other_id":"Pro00103249","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","intervention_model_description":"A two-arm, cluster RCT employing a wait-list control arm will be used. Five cohorts of YA survivors (n=12/cohort) will be randomized with equal allocation to the intervention or control arms.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":39,"population":"","criteria":"\n        Young Adult Cancer Survivors Participating in Intervention Development Interviews\r\n\r\n        Eligibility Criteria\r\n\r\n          -  Diagnosed with hematologic, breast, gastrointestinal, or endocrine cancers, melanoma,\r\n             or germ cell tumors\r\n\r\n          -  Diagnosed with cancer as a young adult\r\n\r\n          -  Under the care of a medical provider at the Duke Cancer Institute\r\n\r\n          -  Completed curative treatment involving multimodal therapy within the last five years\r\n\r\n          -  Able to speak and read English\r\n\r\n          -  Able to give informed consent\r\n\r\n        Exclusion Criteria\r\n\r\n          -  Nonambulatory\r\n\r\n          -  Major mental illness, i.e., schizophrenia\r\n\r\n          -  Untreated or uncontrolled mental illness, i.e., bipolar\r\n\r\n          -  Residence greater than 100 miles from the research site\r\n\r\n        Medical Providers Participating in Intervention Development Interviews Eligibility criteria\r\n\r\n        o Provide care to young adult cancer survivors at the Duke Cancer Institute\r\n\r\n        Young Adult Cancer Survivor User Testers\r\n\r\n        Eligibility Criteria\r\n\r\n          -  Diagnosed with hematologic, breast, gastrointestinal cancers, or endocrine cancers,\r\n             melanoma, or germ cell tumors\r\n\r\n          -  Diagnosed with cancer as a young adult\r\n\r\n          -  Under the care of a medical provider at the Duke Cancer Institute\r\n\r\n          -  Completed curative treatment involving multimodal therapy within the last five years\r\n\r\n          -  Able to speak and read English\r\n\r\n          -  Able to give informed consent\r\n\r\n        Exclusion Criteria\r\n\r\n          -  Nonambulatory\r\n\r\n          -  Major mental illness, i.e., schizophrenia\r\n\r\n          -  Untreated or uncontrolled mental illness, i.e., bipolar\r\n\r\n          -  Residence great than 100 miles from the research site\r\n\r\n        RCT Participants\r\n\r\n        Eligibility Criteria:\r\n\r\n          -  diagnosed with cancer as a YA (aged 18-39)\r\n\r\n          -  diagnosis of hematologic, breast, endocrine or gastrointestinal cancer, melanoma, or\r\n             germ cell tumor\r\n\r\n          -  receiving care at the Duke Cancer Institute\r\n\r\n          -  completed curative treatment involving multimodal therapy within the last 2 years\r\n\r\n          -  able to speak/read English; and able to give informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  non-ambulatory\r\n\r\n          -  major mental illness (i.e., schizophrenia)\r\n\r\n          -  untreated or uncontrolled mental illness (i.e., bipolar disorder)\r\n      ","sponsor":"Duke University","sponsor_type":"Other","conditions":"Pain|Cancer|Young Adult|Psychological Distress|Fatigue|Breast Cancer|Melanoma|Hematologic Cancer|Germ Cell Tumor|Endocrine Cancer","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Behavioral Symptom Management for Young Adult Cancer Survivors","description":"The hybrid intervention will include in-person group sessions along with an integrated mobile application to provide participants with instruction in cognitive and behavioral strategies for managing symptoms (i.e., pain, fatigue, distress). Investigators anticipate that the developed intervention will include 8 face-to-face group sessions (10 therapy hours). Sessions will be delivered using a faded contact approach (i.e., sessions 1-6: weekly, sessions 7-8: biweekly). Participants will receive secure access to a study-specific mobile application that will include: 1) audio and video files and brief text-based educational content reviewing strategies discussed during the groups; 2) the ability to self-monitor symptom severity; 3) the ability to connect with group members via a social networking platform; and 4) activity tracking synchronization."}],"outcomes":[{"outcome_type":"primary","measure":"Intervention Satistfaction: SSTS-R","time_frame":"Following completion of the intervention, up to 12 months","description":"Intervention satisfaction will be assessed using the SSTS-R, a 13-item measure with the first 12-items on a five-point scale ranging from 1 \"strongly disagree\" to 5 \"strongly disagree.\" The 13th item asks, \"How much did the intervention help with your sypmtoms?\" with 5 answer choices ranging from \"made things a lot better\" to made things a lot worse.\""},{"outcome_type":"primary","measure":"Open-Ended Questions About the Program","time_frame":"Following completion of the intervention, up to 12 months","description":"Intervention will be evaluated using 3 open-ended questions, including the following: \"1) What was the most helpful part of the program?,\" \"2) What was the least helpful part of the program?\", and \"3) What suggestions do you have for us to help improve the program?\""},{"outcome_type":"primary","measure":"Session attendance","time_frame":"Following completion of the intervention, up to 12 months","description":"Treatment feasibility will be assessed by measuring the session attendance rate for each participant."},{"outcome_type":"primary","measure":"Treatment Acceptability Questionnaire","time_frame":"Following completion of the intervention, up to 12 months","description":"The Treatment Acceptability Questionnaire is a six-item scale assessing participants' views of an intervention as acceptable, ethical, and effective.\r\nItems are rated on a 7-point Likert scale (e.g., 1 \"very unacceptable\" to 7 \"very acceptable)."},{"outcome_type":"primary","measure":"Change in Depressive Symptoms: PROMIS Depression Short Form","time_frame":"Baseline and again 3, 6, 9, and 12 months following the baseline assessment","description":"Depressive Symptoms will be assessed using the PROMIS Depression Short Form, an 8-item measure assessing symptoms of depression in the last week. Participants are asked to respond to items (e.g., \"I felt sad,\" \"I felt helpless\") using a five-point scale ranging from 1 \"never\" to 5 \"always.\""},{"outcome_type":"primary","measure":"Change in Anxiety: PROMIS Anxiety Short Form","time_frame":"Baseline and again 3, 6, 9, and 12 months following the baseline assessment","description":"Symptoms of Anxiety will be assessed using the PROMIS Anxiety Short Form, an 8-item measure assessing symptoms of anxiety in the last week. Participants are asked to respond to items (e.g., \"I felt nervous,\" \"I felt tense\") using a five-point scale ranging from 1 \"never\" to 5 \"always\"."},{"outcome_type":"primary","measure":"Change in Symptom Interference: Illness intrusiveness rating scale","time_frame":"Baseline and again 3, 6, 9, and 12 months following the baseline assessment","description":"Symptom interference will be assessed using the Illness Intrusiveness Rating Scale (IIRS). The IIRS assesses the extent to which an illness and/ or its treatments interfere with 13 quality of life domains (e.g., health, diet, work, sex life, active recreation). Items are rated on a 7-point scale from 1 \"not very much\" to 7 \"very much.\""},{"outcome_type":"primary","measure":"Use of Intervention Strategies","time_frame":"Following completion of the intervention, up to 12 months","description":"Participants' use of intervention strategies will be assessed using a measure developed specific to components of the proposed intervention. Participants will be asked about how frequently treatment strategies discussed in session have been used outside of session since the previous session or last assessment depending on the timing of the questionnaire. A scale ranging from 0 \"not at all\" to 5 \"2 or more times a day\" will be used."},{"outcome_type":"primary","measure":"Self-reported use of the Mobile Application","time_frame":"Following completion of the intervention, up to 12 months","description":"Participants' use of the mobile application will be assessed using a measure developed specific to components of the proposed mobile application.\r\nParticipants will be asked about how frequently they have used components of the mobile application outside of session since the previous session or last assessment depending on the timing of the questionnaire. A scale ranging from 0 \"not at all\" to 5 \"2 or more times a day\" will be used."},{"outcome_type":"primary","measure":"Change in Pain: Brief Pain Inventory","time_frame":"Baseline and again 3, 6, 9, and 12 months following the baseline assessment","description":"The Brief Pain Inventory is a 9-item, self-report measure assessing pain severity and interference from pain across important life domains (e.g., general activity, work, relations with others). Participants rate their pain on a scale from 0 \"no pain\" to 10 \"pain as bad as you can imagine.\""},{"outcome_type":"primary","measure":"Change in Fatigue: PROMIS Fatigue Short Form","time_frame":"Baseline and again 3, 6, 9, and 12 months following the baseline assessment","description":"Fatigue will be assessed using the PROMIS Fatigue Scale, a 6-item self-report measure of fatigue. Participants are asked to think about the last week when responding to each item (e.g., \"In the past 7 days, how run-down did you feel, on average?\"). Respon"},{"outcome_type":"secondary","measure":"Group Therapy Experiences Scale","time_frame":"Following completion of the intervention, up to 12 months","description":"The 17-item Group Therapy Experiences Scale will be used to assess the level of cohesion among group members (e.g., development of positive relationships, comfort level with other group members). Items 1-16 are rated on a 5-point scale with 1 = \"strongly agree\" to 5 = \"strongly disagree.\" Item 17 is an open-ended question, \"was there something in the group today that helped or hindered you?\"relationships, comfort level with other group members). Items are rated on a 4-point scale with 1= \"strongly disagree\" to 4= \"strongly agree.\""},{"outcome_type":"secondary","measure":"Change in Social Isolation: PROMIS Social Isolation Scale","time_frame":"Baseline and again 3, 6, 9, and 12 months following the baseline assessment","description":"The PROMIS Social Isolation Scale is a 6-item measure is used to assess social isolation. Participants are asked to rate each item (e.g., \"I felt left out,\" \"I feel that people avoid talking to me\") on a scale from 1= \"never\" to 5= \"always.\""},{"outcome_type":"secondary","measure":"Change in Self-Efficacy: The Self-Efficacy for Managing Chronic Disease Scale","time_frame":"Baseline and again 3, 6, 9, and 12 months following the baseline assessment","description":"The Self-Efficacy for Managing Chronic Disease Scale is a 6-item scale. Participants rate their confidence in keeping pain, fatigue, emotional distress, and other symptoms from interfering with things they want to do on a scale from 1 \"not at all confident\" to 10 \"totally confident.\""},{"outcome_type":"secondary","measure":"Change in Self-Efficacy: PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 4a","time_frame":"Baseline and again 3, 6, 9, and 12 months following the baseline assessment","description":"The PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 4a is a 4-item scale. Participants rate their confidence in managing their symptoms during daily activities, with relationships with friends and family, in a public place, and working with their doctor to manage these symptoms on a scale from 1 = \"I am not at all confident\" to 5 \"I am very confident.\""},{"outcome_type":"secondary","measure":"Change in Emotional Support: PROMIS Emotional Support-Short Form","time_frame":"Baseline and again 3, 6, 9, and 12 months following the baseline assessment","description":"The PROMIS Emotional Support Short Form is a 6-item measure used to assess emotional support. Participants are asked to rate each item (\"I have someone who will listen to me when I need to talk,\" \"I have someone to talk with when I have a bad day\") on a scale from 1= \"never\" to 5= \"always.\""},{"outcome_type":"secondary","measure":"Change in Instrumental Support: PROMIS Instrumental Support-Short Form","time_frame":"Baseline and again 3, 6, 9, and 12 months following the baseline assessment","description":"The PROMIS Instrumental Support Short Form is a 6-item measure used to assess instrumental support. Participants are asked to rate each item (e.g., \"Do you have someone to take you to the doctor if you needed it?,\" \"Do you have someone to prepare your meals if you are unable to do it yourself?\") on a scale from 1= \"never\" to 5= \"always.\""},{"outcome_type":"secondary","measure":"Change in Informational Support: PROMIS Informational Support-Short Form","time_frame":"Baseline and again 3, 6, 9, and 12 months following the baseline assessment","description":"The PROMIS Informational Support Short Form is a 6-item measure used to assess informational support. Participants are asked to rate each item (e.g., \"I have someone to turn to for suggestions about how to deal with a problem,\" \"I have someone to give me information if I need it\") on a scale from 1= \"never\" to 5= \"always.\""},{"outcome_type":"other","measure":"Sociodemographics","time_frame":"Baseline","description":"Age, race/ethnicity, relationship status, employment status, occupation, income, and years fo education"},{"outcome_type":"other","measure":"Disease Characteristics","time_frame":"Baseline","description":"Disagnosis and treatment information"},{"outcome_type":"other","measure":"Change in Activity: International Physical Activity Questionnaire","time_frame":"Baseline and again 3, 6, 9, and 12 months following the baseline assessment","description":"The International Physical Activity Questionnaire is a seven-item questionnaire that assesses the amount of time participants have spent doing physical activity (e.g., moderate physical activities, vigorous physical activities, walking) in the last seven"},{"outcome_type":"other","measure":"Change in Activity: Stanford LCAT","time_frame":"Baseline and again 3, 6, 9, and 12 months following the baseline assessment","description":"The Stanford LCAT is a categorical item that asseses the type of physical activities participants do."},{"outcome_type":"other","measure":"Change in Spritual Well-Being: Functional Assessment of Chronic Illness Therapy (FACIT)","time_frame":"Baseline and again 3, 6, 9, and 12 months following the baseline assessment","description":"The FACIT assesses the spiritual wellbeing of participants with 12-item questionnaire on a scale from 0 = \"not at all\" to 4 = \"very much.\""},{"outcome_type":"other","measure":"Changes in Cancer Experience: Acceptance and Action Questionnaires for Cancer (AAQ)","time_frame":"Baseline and again 3, 6, 9, and 12 months following the baseline assessment","description":"The AAQ is an 18-item questionnaire to track phsychological flexibility related to coping with cancer and cancer treatment. The scale ranges from 1 = \"never true\" to 7 \"always true.\" Item is scored by adding all of the responses together."},{"outcome_type":"other","measure":"Changes in Living in Alignment with Values: The Valuing Questionnaire (VQ)","time_frame":"Baseline and again 3, 6, 9, and 12 months following the baseline assessment","description":"The VQ is a 10-item self-report questionnaire with a scale 0 = \"not true at all\" to 6 \"completely true.\""}]}
{"nct_id":"NCT04204772","start_date":"2020-01-22","phase":"Early Phase 1","enrollment":12,"brief_title":"A Pilot Feasibility Study of Activated Charcoal in Healthy Volunteers","official_title":"A Pilot Feasibility Study of Activated Charcoal in Healthy Adult Volunteers","primary_completion_date":"2021-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2021-03-31","last_update":"2021-04-09","description":"This is a pilot study designed to test feasibility, tolerability, and safety of medical grade oral Activated Charcoal (AC) in 12 healthy volunteers.","other_id":"2019LS014","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","intervention_model_description":"12 healthy volunteers will be enrolled to determine the two most palatable and tolerable AC combinations. There will be a total of 4 combinations (2 AC doses and 2 solutions) in stage 1. Each participant will drink an assigned combination every day for 3 consecutive days (Monday, Tuesday, Wednesday, \"M/T/W\") and switch to a different assigned combination M/T/W the following week. AC solution assignments will be defined before the study using a balanced incomplete block design","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age 18 years\r\n\r\n          -  No use of prescription medications, including oral birth control, currently or in the\r\n             last 30 days\r\n\r\n          -  Sexually active women must be using an effective form of contraception. Note that\r\n             subjects who are on oral contraception should use an additional form of contraception\r\n             such as barrier methods, as AC may interfere with the efficacy of oral contraceptive\r\n\r\n          -  Voluntary written consent signed before performance of any study-related procedure\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  At risk of GI hemorrhage or perforation due to underlying pathology, recent surgery,\r\n             or medical conditions that could be adversely affected by the administration of AC\r\n\r\n          -  Planning to have an endoscopic procedure\r\n\r\n          -  Known hypersensitivity to AC\r\n\r\n          -  Non-English speakers\r\n      ","sponsor":"Masonic Cancer Center, University of Minnesota","sponsor_type":"Other","conditions":"Healthy Adult Volunteers","interventions":[{"intervention_type":"Drug","name":"Drug: Activated charcoal","description":"Activated Charcoal, Powder, USP is carbon that has been treated to create low-volume pores that increase the area available for chemical reactions and adsorption. The most common pharmaceutical uses of activated charcoal is as a purification agent and antitoxin. All Spectrum Chemical USP products are manufactured, packaged and stored under current Good Manufacturing Practices (cGMP) per 21CFR part 211 in FDA registered and inspected facilities."}],"outcomes":[{"outcome_type":"primary","measure":"Average palatability rating","time_frame":"two weeks","description":"Each healthy volunteer will rate their experience using a 5-point scale (1=terrible, 2=bad, 3=okay, 4=good, 5=great) every day."},{"outcome_type":"secondary","measure":"Incidence of grade 2 and above AEs related to AC by day 12","time_frame":"12 days"}]}
{"nct_id":"NCT04229121","start_date":"2020-01-15","enrollment":100,"brief_title":"Clinical Sensitivity Verification Study of Circulating Tumor Cells Gene Mutation Detection From Advanced NSCLC Patients","official_title":"Clinical Sensitivity Verification Study of Circulating Tumor Cells Gene Mutation Detection From Advanced NSCLC Patients","primary_completion_date":"2020-06-15","study_type":"Observational","rec_status":"Not yet recruiting","completion_date":"2020-12-15","last_update":"2020-01-18","description":"Verify the Coincidence rate between Circulating tumor cells (CTCs) and tumor tissue or Circulating tumor DNA (ctDNA) of advanced NSCLC patients with Driver gene mutation","other_id":"CTC-FM","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Histologially or cytologically proven diagnosis of advanced NSCLC","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Female or male, 18 years of age or older\r\n\r\n          2. Histologically or cytologically proven diagnosis of advanced NSCLC patients without\r\n             any target therapy or chemotherapy\r\n\r\n          3. Able to get tumor tissue gene (EGFR/ALK/ROS1/RET/MET skipping) testing results by Lung\r\n             cancer Polymerase Chain Reaction (PCR) panel kit carried out in hospital\r\n\r\n          4. Signed and dated informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Combine with other tumor type\r\n\r\n          2. The investigator judges the situation that may affect the clinical search process and\r\n             results\r\n      ","sponsor":"Shanghai Pulmonary Hospital, Shanghai, China","sponsor_type":"Other","conditions":"Advanced NSCLC|Circulating Tumor Cells|Circulating Tumor DNA","interventions":[{"intervention_type":"Other","name":"Other: nonintervention","description":"nonintervention"}],"outcomes":[{"outcome_type":"primary","measure":"Driver gene mutation frequency from CTCs of advanced NSCLC patients","time_frame":"6 months","description":"Analyze the driver gene mutation frequency in CTCs from advanced NSCLC patients with tumor tissue driver gene mutation"},{"outcome_type":"primary","measure":"The gene mutation coincidence rate between CTCs and tumor tissue sample","time_frame":"6 months","description":"Comparison the gene mutation coincidence rate between CTCs and tumor tissue sample"},{"outcome_type":"secondary","measure":"Driver gene mutation frequency from ctDNA of advanced NSCLC patients","time_frame":"6 months","description":"Analyze the driver gene mutation frequency in ctDNA from advanced NSCLC patients with tumor tissue driver gene mutation"},{"outcome_type":"secondary","measure":"The gene mutation coincidence rate between CTCs and ctDNA","time_frame":"6 months","description":"Comparison the gene mutation coincidence rate between CTCs and ctDNA"}]}
{"nct_id":"NCT04030897","start_date":"2020-01-15","phase":"N/A","enrollment":246,"brief_title":"Promoting Treatment Access Following Pediatric Primary Care Depression Screening","official_title":"Promoting Treatment Access Following Pediatric Primary Care Depression Screening: Evaluation of Web-based, Single-session Interventions for Parents and Youths","primary_completion_date":"2021-04-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-08-30","last_update":"2020-03-06","description":"Major depression (MD) in youth is a serious psychiatric illness with extensive morbidity and mortality. The American Academy of Pediatrics recently released practice guidelines promoting primary care (PC)-based youth MD screening; however, even when diagnosed by PC providers, <50% of youth with MD access treatment. Thus, a need exists for interventions that are feasible for youths and parents to access and complete-and that may strengthen parents' likelihood of pursuing longer-term services. Single-session interventions (SSIs) may help forward these goals. SSIs include elements of comprehensive treatments, but their brevity makes them easier to disseminate at scale. Meta-analytic evidence suggests SSIs can reduce youth psychopathology, including self-administered (e.g., online) SSIs. One computer-based SSI, teaching growth mindset (GM; viewing personal traits as malleable), has reduced adolescent depressive symptoms in multiple RCTs; GM-SSIs have also improved parents' expectancies that psychotherapy could benefit their children's mental health. This project will test whether these online, youth- and parent-directed GM-SSIs-designed to reduce youth depressive symptoms and improve parents' mental health treatment expectancies, respectively-may increase mental health service access, reduce youth depressive symptoms, and relieve parental stress following PC-based youth MD screening. Youths reporting elevated MD symptoms at PC visits (N = 200) will receive either Information/Psychoeducation/Referral (IPR) or IPR plus parent- and youth-directed GM-SSIs (IPR+SSI). The investigators will examine whether IPR+SSI, versus IPR alone, increases MD service access; reduces parental stress; and reduces youth depressive symptoms across three months. Results may yield a disseminable model for promoting youth treatment access after PC-based depression screening.","other_id":"IRB2019-00241","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","intervention_model_description":"Youths reporting elevated MD symptoms at a PC visit (N = 200) will be randomly assigned to one of two conditions (within a waitlist-control design): Information, Psychoeducation, and Referral (IPR; ie., usual care, or the \"control\") or IPR enhanced with youth- and parent-directed online SSIs (IPR+SSI), designed to reduce youth MD symptoms and improve parents' expectancies of mental health treatment, respectively.","sampling_method":"","gender":"All","minimum_age":11,"maximum_age":16,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Youth is between the ages of 11 and 16, inclusive, at the time of study recruitment\r\n\r\n          -  Youth reports a Pediatric Symptom Checklist 'Internalizing' score of 5 or higher (out\r\n             of 10) at her/his most recent pediatric primary care visit at 1 of the 9 Stony Brook\r\n             University-affiliated clinics participating in this study\r\n\r\n          -  Parent and youth are comfortable with reading and writing in English\r\n\r\n          -  Parent and youth are comfortable with online activity\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Parent or youth is not comfortable reading and/or writing in English\r\n\r\n          -  Parent or youth is not comfortable with online activity\r\n      ","sponsor":"Stony Brook University","sponsor_type":"Other","conditions":"Depression","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Parent-Directed Online Single-Session Program","description":"Online, 15-minute self-administered program for parents"},{"intervention_type":"Behavioral","name":"Behavioral: Youth-Directed Online Single-Session Program","description":"Online, 30 minute self-administered program for youths"},{"intervention_type":"Behavioral","name":"Behavioral: Information/Psychoeducation/Referral","description":"Usual care at pediatric primary care clinics participating in this study"}],"outcomes":[{"outcome_type":"primary","measure":"Mental Health Treatment-Seeking Behavior Checklist","time_frame":"Baseline to 3-month follow-up","description":"At baseline and 3-month follow-up, parents will indicate whether they have engaged in each of four treatment-seeking behaviors for their child: researched local mental healthcare providers/agencies for their child; contacted a mental healthcare provider or agency about treatment for their child; contacted child's school regarding mental health supports for their child; and scheduled an appointment OR placed child on a waiting-list with a mental healthcare provider/agency. Total number of treatment-seeking behaviors between baseline and 3-month follow-up may range from 0 to 4. Individual behaviors are self-reported by parents on as 'yes' or 'no' (noting whether they engaged in the behavior during the study period). At baseline, parents will report on whether they engaged in these behaviors 'since the child's last doctor's appointment.' At follow-up, parents will report whether they have engaged in these behaviors 'since their past survey, 3 months ago.'"},{"outcome_type":"primary","measure":"Change in Children's Depression Inventory 2 - Youth Report Total Score","time_frame":"Baseline to 3-month follow-up.","description":"Change in youth reported depressive symptoms, total score derived from 28-item CDI-2. Scores range from 0-56, with higher scores indicating higher levels of depression."},{"outcome_type":"secondary","measure":"Change in Pediatric Symptom Checklist - Youth-Report Total score","time_frame":"Baseline to 3-month follow-up.","description":"Youth-report measure of overall youth psychopathology. Youth rate 35 items on a 0-2 scale reflecting internalizing, externalizing, and attention-related symptoms. Scores range from 0 - 70. Higher scores indicate higher overall symptom severity."},{"outcome_type":"secondary","measure":"Change in Pediatric Symptom Checklist- Parent Report Total score","time_frame":"Baseline to 3-month follow-up.","description":"Youth-report measure of overall youth psychopathology. Youth rate 35 items on a 0-2 scale reflecting internalizing, externalizing, and attention-related symptoms. Scores range from 0 - 70. Higher scores indicate higher overall symptom severity."},{"outcome_type":"secondary","measure":"Change in Pediatric Symptom Checklist- Youth Internalizing Score (parent report)","time_frame":"Baseline to 3-month follow-up.","description":"Parent-report measure of overall youth psychopathology. Parents rate 5 items on a 0-2 scale reflecting internalizing symptoms in their child. Scores range from 0-10. Higher scores indicate higher overall symptom severity."},{"outcome_type":"secondary","measure":"Change in Beck Hopelessness Scale - 4 (Youth Report)","time_frame":"Baseline to immediate post-online-intervention (in active intervention group only) and 3-month follow-up (between groups).","description":"Respondents (youths) report agreement with 4 items indicating levels of hopelessness about the future. Higher summed scores reflect greater levels of hopelessness, and scores range from 0-12."},{"outcome_type":"secondary","measure":"Change in Beck Hopelessness Scale - 4 (Parent Report)","time_frame":"Baseline to immediate post-online-intervention (in active intervention group only) and 3-month follow-up (between groups).","description":"Respondents (parents) report agreement with 4 items indicating levels of hopelessness about the future. Higher summed scores reflect greater levels of hopelessness, and scores range from 0-12."},{"outcome_type":"secondary","measure":"Change in Brief Symptom Inventory - 18","time_frame":"Baseline to 3-month follow-up","description":"The Brief Symptom Inventory-18 (BSI-18) assesses self reported parent psychopathology and distress. Adult respondents rate endorsement of 18 physical and emotional complaints on a 0-4 Likert scale. The total sum score yields an additional total distress score (range: 0-72). Higher scores indicate higher levels of overall psychological distress."},{"outcome_type":"secondary","measure":"Change in Barriers to Accessing Care Evaluation (BACE)","time_frame":"Baseline to 3-month follow-up","description":"Parents rate the 30 items on a 0-3 scale indicating the degree to which various beliefs, concerns, circumstances, and logistical difficulties have stopped, delayed or discouraged them from getting professional care for their child's mental health problem. Higher total scores indicate greater perceived barriers to care. Scores range from 0-90, with higher scores indicating more overall barriers to accessing mental health care for their child."},{"outcome_type":"secondary","measure":"Change in Attitudes Toward Therapy Scale - Parent","time_frame":"Baseline to immediate post-online-intervention (in active intervention group only) and 3-month follow-up (between groups).","description":"One-item measure used to assess parents' perceptions that therapy/counseling would be useful in reducing their child's emotional or behavioral difficulties, rated on a 0-10 scale (total score range: 0-10). Higher scores indicate stronger beliefs that therapy may help reduce mental health problems, whereas lower scores indicate weaker beliefs that therapy may help reduce mental health problems."},{"outcome_type":"secondary","measure":"Mental Health Treatment Access at 3-month follow-up","time_frame":"3-month follow-up","description":"Parents will indicate (yes/no) whether their child has received (a) new and/or (b) continuing school-based, outpatient, or other mental health-related services since the child's recent PC appointment (at baseline) and since the baseline assessment (at 3-month follow-up)."},{"outcome_type":"secondary","measure":"Change in Perceived Stress Scale","time_frame":"Baseline to 3-month follow-up","description":"The PSS is a well-validated measure of the degree to which situations in one's life are appraised as stressful, unpredictable, and uncontrollable. Higher total scores indicate greater overall perceived stress. The scale includes 10 items rated on a 0-4 scales, and scores range from 0-40."},{"outcome_type":"secondary","measure":"Change in Pediatric Symptom Checklist - Youth-Report Internalizing Score","time_frame":"Baseline to 3-month follow-up.","description":"Youth-report measure of youth depressive symptoms. Youth rate 5 items reflecting internalizing symptoms on a scale from 0-2. Total scores range from 0 to 10. Higher scores indicate higher internalizing symptom severity."},{"outcome_type":"secondary","measure":"Change in Children's Depression Inventory 2 - Parent Report total score","time_frame":"Baseline to 3-month follow-up.","description":"Parent reported youth depressive symptoms, total score derived from 17-item parent-report version of CDI-2. Scores range from 0-54, and higher scores indicate greater youth depression severity."},{"outcome_type":"other","measure":"Change in implicit theories of emotion scale, parent-report","time_frame":"Baseline to immediate-post-online intervention (active intervention group only)","description":"This measure will be used as a manipulation check for parents assigned to the active intervention condition. Parents will be asked to report the degree to which they view emotions as malleable (versus immutable) at pre- and post-intervention using a previously validated, 4-item assessment of emotion mindsets in adults. Four items are rated using a 1-to-6 Likert scale. Higher mean scores on these items indicate a stronger fixed emotion mindset, a lower scores, a stronger growth emotion mindset (range: 1-)."},{"outcome_type":"other","measure":"Change in Implicit Theories of Personality Questionnaire, youth-report","time_frame":"Baseline to immediate-post-online intervention (active intervention group only)","description":"This measure will be used as a manipulation check for youths assigned to the active intervention condition. Respondents rate the extent of their agreement with three statements linked to the malleability of personality, using a 1-to-6 Likert scale (e.g. \"Your personality is something about you that you can't change very much\"). Higher mean scores on these three items indicate a stronger fixed personality mindset, a lower scores, a stronger growth personality mindset (range: 1-6)."}]}
{"nct_id":"NCT04210479","start_date":"2020-01-15","phase":"N/A","enrollment":64,"brief_title":"Comparison of Bladder Filling vs. Non-Filling in Cesarean Hysterectomy for Placenta Percreta","official_title":"Bladder Filling in Cesarean Hysterectomy for Placenta Percreta: A Randomized Trial","primary_completion_date":"2021-03-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2021-06-30","last_update":"2019-12-24","description":"The placenta accreta spectrum (PAS) which includes accreta, increta, and percreta represents a significant obstetric challenge. PAS complicates as many as 1 per 500 pregnancies and this risk is increased with prior cesarean deliveries. Antenatal diagnosis of PAS allows for multidisciplinary planning and delivery before the onset of labor and/or vaginal bleeding. This approach has reduced maternal morbidity rates. including less blood loss, fewer transfusion requirements and, intraoperative urinary tract injury as well as improve fetal outcome. Ultrasound evaluation is the recommended first-line modality for diagnosing PAS. Ultrasound features suggestive of PAS include loss of the normal retroplacental clear zone, attenuation of the uterine-bladder interface, reduced retroplacental myometrial thickness, presence of intraplacental lacunar spaces, and bridging vessels between the placenta and bladder. A systematic review reported that the antenatal diagnosis of PAS significantly lowered the rate of urinary tract injury (from 63% to 39%) during cesarean hysterectomies in these cases. Unlike other elective cesarean hysterectomies, cesarean hysterectomy with a placenta previa increta/percreta, is more difficult. There is a greater need to both keep a margin from the vascular cervical-placental mass and simultaneously protect the urinary bladder. Case series reported that bladder filling helps the surgeon to more clearly identify the planes of dissection and secure the engorged aberrant vessels, thereby reduces bladder injury. Accordingly, a prospective randomized study in pregnant patients with placenta previa increta/percreta undergoing elective cesarean hysterectomy will be conducted to address this important issue.","other_id":"MS.19.12.939","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":44,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Pregnant women in their third trimester (35-37 W).\r\n\r\n          -  Placenta previa accreta spectrum identified by the Ultrasound (low lying anterior or\r\n             major degree anterior).\r\n\r\n          -  With at least one prior cesarean section.\r\n\r\n          -  Elective cesarean hysterectomy.\r\n\r\n          -  Evidence of gross placental invasion at the time of surgery (FIGO grade 3a.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients undergoing conservative treatment.\r\n\r\n          -  Emergency cesarean hysterectomy.\r\n\r\n          -  No evidence of gross placental invasion at the time of surgery.\r\n\r\n          -  Posterior placenta.\r\n      ","sponsor":"Hatem AbuHashim","sponsor_type":"Other","conditions":"Placenta Accreta","interventions":[{"intervention_type":"Procedure","name":"Procedure: Filled-bladder","description":"Urinary bladder filling with 300 ml diluted methylene blue"},{"intervention_type":"Procedure","name":"Procedure: non filled-bladder","description":"Pull up the empty (non-filled) urinary bladder using Allis forceps"}],"outcomes":[{"outcome_type":"primary","measure":"Rate of urinary bladder injury","time_frame":"Intra-operative (i.e. during surgery).","description":"Unintentional bladder injury during elective cesarean hysterectomy"}]}
{"nct_id":"NCT04088487","start_date":"2020-01-14","phase":"N/A","enrollment":178,"brief_title":"New in Town-Internet Intervention for Migrants","official_title":"New in Town-Internet Intervention for Migrants: a Randomized Controlled Trial","primary_completion_date":"2020-04-03","study_type":"Interventional","rec_status":"Terminated","completion_date":"2020-05-08","last_update":"2020-11-13","description":"New in Town is an internet intervention for migrants that aims at increasing social self-efficacy. The study aim is to evaluate its effectiveness.","other_id":"WP/2018/A/10","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  age of at least 18 years\r\n\r\n          -  having changed the place of residence in the last 6 months\r\n\r\n        Exclusion Criteria:\r\n\r\n        - no access to a internet\r\n      ","sponsor":"University of Social Sciences and Humanities, Warsaw","sponsor_type":"Other","conditions":"Self Efficacy|Loneliness|Social Skills","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: New in Town-Interner Intervention for Migrants","description":"New in Town is an internet intervention for migrants that aims at increasing social self-efficacy. Exercises in the intervention are based on the principles of Cognitive Behavioral Therapy and relate to four sources of self-efficacy beliefs-mastery experiences, vicarious experiences, verbal persuasions, and emotional and physiological states (Bandura, 1997)."}],"outcomes":[{"outcome_type":"primary","measure":"Change on Social Self-Efficacy","time_frame":"Change from baseline on Social Self-Efficacy (3 weeks)","description":"Social self-efficacy will be measured with the General Self-efficacy Scale (GSES). The measure consists of two subscales for measuring 1) generalized beliefs about self-efficacy (17 test items) and 2) beliefs about self-efficacy in establishing and maintaining relationships with others (6 test items). The remaining test items (7) are buffer theorems. The respondents give answers on a scale 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). In the trial, the investigators will use one subscale, which is beliefs about self-efficacy in establishing and maintaining relationships with others. Social self-efficacy will be indicated by the total sum of 6 items scores. The higher total score represents higher social self-efficacy."},{"outcome_type":"primary","measure":"Change on Social Self-Efficacy","time_frame":"Change from baseline on Social Self-Efficacy (8 weeks)","description":"Social self-efficacy will be measured with the General Self-efficacy Scale (GSES). The measure consists of two subscales for measuring 1) generalized beliefs about self-efficacy (17 test items) and 2) beliefs about self-efficacy in establishing and maintaining relationships with others (6 test items). The remaining test items (7) are buffer theorems. The respondents give answers on a scale 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). In the trial, the investigators will use one subscale, which is beliefs about self-efficacy in establishing and maintaining relationships with others. Social self-efficacy will be indicated by the total sum of 6 items scores. The higher total score represents higher social self-efficacy."},{"outcome_type":"secondary","measure":"Change on Loneliness","time_frame":"Change from baseline on Loneliness (3 weeks)","description":"To measure loneliness, the investigators will use De Jong Gierveld Loneliness Scale. The scale is composed of 11 items; 6 of them are formulated negatively and 5 positively. Each item is measured using on 5-point Likert scale (1 = definitely yes, 5 = definitely no). Positive items should be reversed. The sum of scores is counted on 2 separate subscales: emotional and social loneliness. The higher total score represents higher loneliness."},{"outcome_type":"secondary","measure":"Change on Loneliness","time_frame":"Change from baseline on Loneliness (8 weeks)","description":"To measure loneliness, the investigators will use De Jong Gierveld Loneliness Scale. The scale is composed of 11 items; 6 of them are formulated negatively and 5 positively. Each item is measured using on 5-point Likert scale (1 = definitely yes, 5 = definitely no). Positive items should be reversed. The sum of scores is counted on 2 separate subscales: emotional and social loneliness. The higher total score represents higher loneliness."},{"outcome_type":"secondary","measure":"Change on Social support","time_frame":"Change from baseline on Social support (3 weeks)","description":"To measure social support, the investigators will use The Berlin Social Support Scale (BSSS). The scale consists of 6 subscales: perceived available support, need for support, support seeking, actually received support (recipient), provided support (provider), protective buffering scale. The BSSS contains 32 items that are scored on a 4-point scale (1 = strongly disagree, 4 = strongly agree). Before scoring items negative ones need to be reversed. Scores will be counted both on a general scale and subscales. In the trial, only 3 of 6 subscales will be applied: perceived available support (8 test items), need for support (4 test items), and support seeking (5 test items). The higher total score represents higher social support."},{"outcome_type":"secondary","measure":"Change on Social support","time_frame":"Change from baseline on Social support (8 weeks)","description":"To measure social support, the investigators will use The Berlin Social Support Scale (BSSS). The scale consists of 6 subscales: perceived available support, need for support, support seeking, actually received support (recipient), provided support (provider), protective buffering scale. The BSSS contains 32 items that are scored on a 4-point scale (1 = strongly disagree, 4 = strongly agree). Before scoring items negative ones need to be reversed. Scores will be counted both on a general scale and subscales. In the trial, only 3 of 6 subscales will be applied: perceived available support (8 test items), need for support (4 test items), and support seeking (5 test items). The higher total score represents higher social support."},{"outcome_type":"secondary","measure":"Change on Satisfaction with life","time_frame":"Change from baseline on Satisfaction with life (3 weeks)","description":"To measure satisfaction with life, the investigators will use The Satisfaction with Life Scale (SWLS). It is a short scale to assess perceived satisfaction with one's life. It consists of 5 items. The respondents provide answers on a 7-point scale (1 = strongly disagree, 7 = strongly agree). Possible scores range from 5 to 35, while score of 20 indicates a neutral point. The higher total score represents higher satisfaction with life."},{"outcome_type":"secondary","measure":"Change on Satisfaction with life","time_frame":"Change from baseline on Satisfaction with life (8 weeks)","description":"To measure satisfaction with life, the investigators will use The Satisfaction with Life Scale (SWLS). It is a short scale to assess perceived satisfaction with one's life. It consists of 5 items. The respondents provide answers on a 7-point scale (1 = strongly disagree, 7 = strongly agree). Possible scores range from 5 to 35, while score of 20 indicates a neutral point. The higher total score represents higher satisfaction with life."},{"outcome_type":"other","measure":"System usability","time_frame":"3-week post-test (only experimental group)","description":"An overall impression of the intervention will be assessed by The User Experience Questionnaire (UEQ). It is a self-reported measure that contains 6 subscales: attractiveness, perspicuity, efficiency, dependability, stimulation, novelty. Participants respond to 26 items using a 7-point scale (-3 = the most negative answer, 0 = neutral, +3 = the most positive answer). User experience will only be assessed at post-test among participants allocated to the experimental group."}]}
{"nct_id":"NCT04214353","start_date":"2020-01-14","phase":"N/A","enrollment":14,"brief_title":"PSMA-PET Imaging Before and After ADT in Advanced SDC Patients","official_title":"Effect of Androgen Deprivation Therapy on Uptake of PSMA Ligand in Patients With Salivary Duct Carcinoma: an Explorative Study.","primary_completion_date":"2022-01-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-01-31","last_update":"2021-04-09","description":"Explorative study, which evaluates the effect of androgen deprivation therapy (ADT) on the PSMA ligand uptake on 68Ga-PSMA-PET/CT in salivary duct carcinoma patients.","other_id":"MOHN19","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients must have the ability to provide written informed consent.\r\n\r\n          -  Patients must be  18 years of age.\r\n\r\n          -  Patients must have histological, pathological, and/or cytological confirmation of\r\n             salivary duct carcinoma, androgen receptor positive.\r\n\r\n          -  Only patients with locally advanced, recurrent or metastatic salivary duct carcinoma\r\n             can participate.\r\n\r\n          -  Patients must have at least one lesion with a diameter of  1.5 cm.\r\n\r\n          -  Patients whom intend to start androgen deprivation therapy, after this has been\r\n             recommended by the treating physician as standard treatment.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Contra-indication for PET imaging (pregnancy, breast feeding severe claustrophobia)\r\n\r\n          -  Impaired renal function: MDRD <30 ml/min/1,73 m2\r\n\r\n          -  Impaired liver function: AST and ALT ALT  2.5 x ULN (5 x ULN for patients with liver\r\n             metastases)\r\n      ","sponsor":"Radboud University","sponsor_type":"Other","conditions":"Salivary Gland Cancer|Salivary Duct Carcinoma","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: 68Ga-PSMA-PET/CT","description":"All participants in the study will be injected with 2.0 MBq/kg 68Ga-PSMA for PET/CT imaging, both pre- and post ADT."},{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: 18FDG-PET/CT","description":"All participants in the study will be injected with 2.1 MBq/kg 18FDG for PET/CT imaging, both pre- and post ADT."}],"outcomes":[{"outcome_type":"secondary","measure":"Diagnostic added value 68Ga-PSMA-PET/CT and 18FDG-PET/CT.","time_frame":"Up to 4 weeks","description":"The number of lesions detected by each imaging modality (diagnostic CT, 68Ga-PSMA-PET/CT and 18FDG-PET/CT) will be measured."},{"outcome_type":"secondary","measure":"Correlation PSMA expression and PSMA ligand uptake","time_frame":"Up to 6 months","description":"The tumor uptake (SUV) will be correlated to the degree of immunohistochemical PSMA expression on the most recent tumormaterial."},{"outcome_type":"secondary","measure":"Change in 68Ga-PSMA uptake of tumor lesions","time_frame":"Up to 4 weeks","description":"Comparison of SUV (standardized uptake value) in 68Ga-PSMA PET/CT between lesions before and 3 weeks after the initiation of ADT (± 1 week)."},{"outcome_type":"primary","measure":"Percentage of patients with a change in PSMA ligand uptake after ADT","time_frame":"Up to 4 weeks","description":"The percentage of patients with an androgen deprivation therapy (ADT) induced change in PSMA ligand uptake on 68Ga-PSMA-PET/CT.\r\npre-scan: baseline (before ADT), post-scan: 3 weeks after start ADT (± 1 week)."},{"outcome_type":"secondary","measure":"Change in 18FDG uptake of tumor lesions","time_frame":"Up to 4 weeks","description":"Comparison of SUV (standardized uptake value) in 18FDG-PET/CT between lesions before and 3 weeks after the initiation of ADT (± 1 week)."},{"outcome_type":"secondary","measure":"Lesions detected by 68Ga-PSMA-PET/CT pre- and post ADT","time_frame":"Up to 4 weeks","description":"The number of lesions detected on 68Ga-PSMA-PET/CT imaging will be measured, both before and after ADT."},{"outcome_type":"secondary","measure":"FDG and PSMA uptake patterns of SDC disease","time_frame":"Up to 4 weeks","description":"FDG and PSMA uptake patterns of SDC disease on 68Ga-PSMA-PET/CT and 18FDG-PET/CT will be measured, e.g. to explore if most lesions show both FDG and PSMA uptake, or if the lesions show a more heterogenous uptake."}]}
{"nct_id":"NCT04226040","start_date":"2020-01-13","enrollment":1004,"brief_title":"Degree-of-worry and Illness Perception in Patients Suffering From Acute Illness in the Emergency Department","official_title":"Degree-of-worry and Illness Perception in Patients Suffering From Acute Illness in the Emergency Department","primary_completion_date":"2020-12-31","study_type":"Observational [Patient Registry]","rec_status":"Recruiting","completion_date":"2022-01-15","last_update":"2020-11-23","description":"This study explores whether and how DOW, as a PRO marker, can contribute to triage in the Emergency Departments. The study is designed as a mixed-method study consisting of a survey among acutely ill patients and qualitative semi-structured interviews.","other_id":"HvidovreDOW1","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"The survey: 1004 adults (18 years of age) who accept to participate in the study. The\r\n        patients are at the Emergency Department due to acute illness.\r\n\r\n        The interviews: of the 1004 patients 10 (+/- 10 patients are invited to participate in a\r\n        semi-structured interview. The recruitment is based on purposeful sampling with maximum\r\n        variation.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18 years of age\r\n\r\n          -  cognitively intact\r\n\r\n          -  consent to participation.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  patients arriving to the ED regarding injury\r\n\r\n          -  patient with the highest triage level\r\n\r\n          -  demented patients\r\n\r\n          -  intoxicated patients\r\n      ","sponsor":"Hvidovre University Hospital","sponsor_type":"Other","conditions":"Acute Illness","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: DOW and illness perception","description":"Acutely ill patients are exposed to a survey regarding their degree of worry and illness perception"}],"outcomes":[{"outcome_type":"primary","measure":"DOW and illness perception","time_frame":"30 minutes","description":"Self-reported degree-of-worry during acute illness scored on a 1-10 scale (1=minimal concern, 10=maximum concern) and illness perception measured using the Brief illness perception Questionnarie"},{"outcome_type":"secondary","measure":"DOW and re-presentation in the Emergency Department","time_frame":"30 days","description":"Self-reported degree-of-worry during acute illness scored on a 1-10 scale (1=minimal concern, 10=maximum concern) and representation in the Emergency Department during the following 30 days"},{"outcome_type":"secondary","measure":"DOW and patient barriers","time_frame":"30 minutes","description":"10 (+/- 10) semi-structured interviews to explore potential patient barriers to implement the DOW-scale in Emergency Departments"}]}
{"nct_id":"NCT03872349","start_date":"2020-01-09","phase":"N/A","enrollment":38,"brief_title":"Effects of Monounsaturated Fatty Acids on Intestinal Lipid Metabolism in Insulin Resistant Subjects (MUFA )","official_title":"Differential Effects of Saturated and Monounsaturated Fatty Acids on Chylomicron Secretion and Expression of Key Genes That Regulate Intestinal Lipid Metabolism in Insulin Resistant Subjects","primary_completion_date":"2021-08-19","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-08-19","last_update":"2021-09-01","description":"The overaccumulation of apolipoprotein (apo)B-48-containing lipoproteins of intestinal origin observed in patients with insulin-resistance is now thought to be attributable to both elevated intestinal production and reduced clearance of these lipoproteins. Substantial evidence exists indicating that elevated plasma levels of these lipoproteins are associated with increased cardiovascular disease (CVD) risk. Therefore, reduction of atherogenic plasma triglyceride-rich lipoproteins  (TRL) levels of intestinal origin appears to be crucial to improve CVD risk associated with insulin-resistance. In this regard, there is some evidence that the clinical recommendation to replace dietary saturated fatty acids (SFAs) by monounsaturated fatty acids (MUFAs) reduces CVD risk in the general population. Although the beneficial impact of PUFAs on CVD risk has been related primarily to favorable changes in plasma LDL-cholesterol levels, recent data suggest that chronic MUFA consumption may also exert beneficial effects on CVD risk by reducing postprandial lipemia. The impact of substituting SFAs by MUFAs on postprandial lipid response may be of even greater significance in dyslipidemic patients with insulin-resistance among whom intestinal TRLs represent a large proportion of the atherogenic lipoproteins. The general objective of the proposed research is to investigate how dietary MUFAs in place of SFAs modify intestinal lipoprotein metabolism in men and women with dyslipidemia associated with insulin-resistance. The investigators hypothesize that the intestinal secretion of apoB-48-containing lipoproteins will be lower following a diet rich in MUFAs than after consuming a diet rich in SFAs. The investigators also hypothesize that substitution of SFAs by MUFAs will be associated with significant alterations in expression of key genes and proteins involved in intestinal lipoprotein metabolism.","other_id":"INAF-MUFA","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Prevention","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Men and women aged between 18-60 years\r\n\r\n          -  Waist circumference > 102 cm (men) and > 88 cm (women)\r\n\r\n          -  HDL-cholesterol < 1.1 mmol/L (men) and < 1.3 mmol/L (women)\r\n\r\n          -  Triglycerides > 1.7 mmol/L\r\n\r\n          -  Fasting blood glucose > 6.1 mmol/L\r\n\r\n          -  Normal blood pressure (<130/85)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Men and women < 18 or > 60 years\r\n\r\n          -  Smokers (> 1 cigarette/day)\r\n\r\n          -  Body weight variation > 10% during the last 6 months prior to the study baseline\r\n\r\n          -  Subjects with a previous history of cardiovascular disease\r\n\r\n          -  Subjects with type 2 diabetes\r\n\r\n          -  Subjects with a monogenic dyslipidemia\r\n\r\n          -  Subjects on hypertension medications or medications known to affect lipoprotein\r\n             metabolism or the integrity of gastrointestinal mucosa\r\n\r\n          -  Subjects with endocrine or gastrointestinal disorders\r\n\r\n          -  History of alcohol or drug abuse within the past 2 years\r\n\r\n          -  Subjects who are in a situation or have any condition that, in the opinion of the\r\n             investigator, may interfere with optimal participation in the study.\r\n      ","sponsor":"Laval University","sponsor_type":"Other","conditions":"Metabolic Syndrome","interventions":[{"intervention_type":"Other","name":"Other: Monounsaturated fatty acids diet","description":"During 4 weeks, subjects eat a diet high in monounsaturated fatty acids and will have a duodenal gastroscopy and a kinetic study at the end of the 4-week period."},{"intervention_type":"Other","name":"Other: Saturated fatty acids diet","description":"During 4 weeks, subjects eat a diet high in saturated fatty acids and will have a duodenal gastroscopy and a kinetic study at the end of the 4-week period."}],"outcomes":[{"outcome_type":"secondary","measure":"Changes in duodenal expression of diacylglycerol acyltransferase, Acyl-CoA:cholesterol O-acyltransferase 2 and 3-hydroxy-methylglutaryl-CoA reductase.","time_frame":"At week 4 and week 12 (at the end of the two 4-weeks diets)"},{"outcome_type":"secondary","measure":"Change in synthesis of apoB-48 containing lipoproteins (Microsomal triglyceride transfer protein (MTP), apoB-48).","time_frame":"At week 4 and week 12 (at the end of the two 4-weeks diets)"},{"outcome_type":"primary","measure":"Change in TRL apolipoprotein B48 (apoB-48) production rate.","time_frame":"At week 4 and week 12 (at the end of the two 4-weeks diets)"},{"outcome_type":"secondary","measure":"Changes in duodenal expression of Niemann-Pick C1-like 1, Adenosine triphosphate-binding cassette transporters, Fatty Acid Binding Protein, Sterol Regulatory Element Binding Protein.","time_frame":"At week 4 and week 12 (at the end of the two 4-weeks diets)"}]}
{"nct_id":"NCT04227327","start_date":"2020-01-07","phase":"Phase 2","enrollment":121,"brief_title":"Study Evaluating Abemaciclib + Aromatase Inhibitors in HR+, HER2- Advanced Breast Cancer Patients (HERMIONE-7)","official_title":"A Phase 2, Open Label, Multicenter, Single Arm Trial Evaluating the Activity and Safety of Abemaciclib + Aromatase Inhibitors (AIs) After 1st-line Treatment With High-Dose Fulvestrant in Hormone-Receptor-Positive (HR+), Human-Epidermal-Growth-factor-negative (HER2-) Advanced Breast Cancer Patients. The HERMIONE-7 Trial","primary_completion_date":"2023-07-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-12-31","last_update":"2021-07-13","description":"The HERMIONE-7 trial is a phase II, single-arm, open-label, multicenter study in HR+, HER2- advanced breast cancer patients who have received HD-FUL as first-line endocrine treatment for their metastatic disease. Patients will receive aromatase inhibitors plus Abemaciclib.","other_id":"HERMIONE-7","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Female  18 years of age regardless of menopausal status, who have relapsed while on\r\n             prior first-line therapy with HD-FUL\r\n\r\n          2. Patients with advanced (loco-regionally recurrent, or metastatic) breast cancer not\r\n             amenable to curative therapy.\r\n\r\n          3. Patient has a histological and/or cytological confirmed diagnosis of estrogen-receptor\r\n             positive and/or progesterone receptor positive breast cancer by local laboratory.\r\n\r\n          4. Patient has HER2-negative breast cancer defined as a negative in situ hybridization\r\n             test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization\r\n             (FISH, CISH, or SISH) test is required by local laboratory testing.\r\n\r\n          5. WHO performance status of 0-2\r\n\r\n          6. Measurable disease (according to Response Evaluation Criteria in Solid Tumors\r\n             [RECIST], version 1.1) or at least one lytic bone lesion\r\n\r\n          7. The patient is able to swallow oral medications.\r\n\r\n          8. The patient has adequate organ function\r\n\r\n          9. Patient has signed ICF (ICF) obtained before any trial-related activities Patients\r\n             must be able to communicate with the investigator and comply with the requirements of\r\n             the study procedures.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patient has a known hypersensitivity to any of the excipients of Abemaciclib or\r\n             letrozole/anastrozole\r\n\r\n          2. Patient who received any CDK4/6 inhibitor\r\n\r\n          3. Patient who received > 1 prior systemic hormonal therapy for advanced breast cancer;\r\n             the only admitted previous therapy as 1st-line treatment is HD FUL. Note: Patients who\r\n             received  28 days of letrozole or anastrozole for advanced disease prior to inclusion\r\n             in this trial are eligible.\r\n\r\n          4. Patient who has not had resolution of all acute toxic effects of prior anti-cancer\r\n             therapy to NCI CTCAE version 4.03 Grade  1 (except alopecia or other toxicities not\r\n             considered a safety risk for the patient at investigator's discretion)\r\n\r\n          5. Patient who has received extended-field radiotherapy  4 weeks or limited field\r\n             radiotherapy for palliation  2 weeks prior to start of treatment, and who has not\r\n             recovered to grade 1 or better from related side effects of such therapy (with the\r\n             exception of alopecia or other toxicities not considered a safety risk for the patient\r\n             at the investigator's discretion).\r\n\r\n          6. Patients from whom  25% (Ellis RE 1961) of the bone marrow has been previously\r\n             irradiated are also excluded.\r\n\r\n          7. Patient has a concurrent malignancy or malignancy within 3 years prior to starting\r\n             study drug, with the exception of treated, basal or squamous cell carcinoma, non\r\n             melanomatous skin cancer or curatively resected cervical cancer.\r\n\r\n          8. Patient with central nervous system (CNS) metastases unless they meet ALL of the\r\n             following criteria:\r\n\r\n               1. At least 4 weeks from prior therapy for CNS disease completion (including\r\n                  radiation and/or surgery) to starting the study treatment\r\n\r\n               2. Clinically stable CNS lesions at the time of study treatment initiation and not\r\n                  receiving steroids and/or enzyme-inducing anti-epileptic medications for the\r\n                  management of brain metastases for at least 2 weeks\r\n\r\n          9. Patient has impairment of gastrointestinal (GI) function or GI disease that may\r\n             significantly alter the absorption of the study drugs (e.g., uncontrolled ulcerative\r\n             diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small\r\n             bowel resection, or preexisting Crohn's disease or ulcerative colitis, or a\r\n             preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea)\r\n\r\n         10. Patient has a known history of HIV infection (testing not mandatory)\r\n\r\n         11. The patient has serious preexisting medical condition(s) that, in the judgment of the\r\n             investigator, would preclude participation in this study (such as severe renal\r\n             impairment, [for example, estimated creatinine clearance <30 mL/min], interstitial\r\n             lung disease, sever dyspnea at rest or requiring oxygen therapy\r\n\r\n         12. The patient has a personal history of any of the following conditions: syncope of\r\n             cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but\r\n             not limited to, ventricular tachycardia and ventricular fibrillation), or sudden\r\n             cardiac arrest. Exception: patients with controlled atrial fibrillation for >30 days\r\n             prior to randomization are eligible. Any patient with a history of VTE (for example,\r\n             DVT of the leg or arm and/or PE) will be excluded.\r\n      ","sponsor":"University of Milano Bicocca","sponsor_type":"Other","conditions":"Advanced Breast Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Abemaciclib","description":"Abemaciclib will be administered orally at 150 mg twice daily"},{"intervention_type":"Drug","name":"Drug: Aromatase Inhibitors","description":"Letrozole 2,5 mg daily or Anastrozole 1 mg daily"}],"outcomes":[{"outcome_type":"primary","measure":"Clinical benefit rate (CBR) in HD-FUL pre-treated MBC patients treated with Abemaciclib + aromatase inhibitors (letrozole or anastrozole)","time_frame":"At 6 months from treatment initiation","description":"CBR is defined as the proportion of patients in Complete Response (CR), Partial Response (PR) or with Stable Disease (SD) >= 24 weeks (as defined by RECIST 1.1 Criteria) evaluated at 6 months from treatment initiation."},{"outcome_type":"secondary","measure":"Time To Progression (TTP)","time_frame":"Through study completion, an average of 42 months","description":"TTP is defined as the time from date of start of treatment to the date of event, i.e. the first documented progression or death due to underlying cancer"},{"outcome_type":"secondary","measure":"Overall Response Rate (ORR)","time_frame":"Through study completion, an average of 42 months","description":"ORR is defined as the proportion of patients with best overall response of CR or PR) according to RECIST 1.1."},{"outcome_type":"secondary","measure":"Duration of Overall Response (DoOR)","time_frame":"Through study completion, an average of 42 months","description":"DoOR is defined as the time of initial response until documented tumor progression"},{"outcome_type":"secondary","measure":"Duration of Clinical Benefit (DoCB)","time_frame":"Through study completion, an average of 42 months","description":"DoCB is defined as the time of initial CB until documented tumor progression"},{"outcome_type":"secondary","measure":"To assess the safety profile of Abemaciclib in association with aromatase inhibitors (letrozole or anastrozole)","time_frame":"Through study completion, an average of 42 months","description":"The Medical Dictionary for Regulatory Activities (MedDRA) Version 19.0 (or higher) will be used when reporting AEs by MedDRA terms. The MedDRA Lower Level Term will be used in the treatment-emergent computation. Treatment-emergent adverse events will be summarized by System Organ Class (SOC) and by decreasing frequency of Preferred Term within SOC."}]}
{"nct_id":"NCT04320823","start_date":"2020-01-06","phase":"N/A","enrollment":3443,"brief_title":"IMPACT (Improving Plasma Collection) Clinical Trial","official_title":"Prospective, Randomized, Controlled, Multicenter Clinical Trial to Demonstrate the Safety and Effectiveness of the NexSys PCS Plasma Collection System With the Percent Plasma Nomogram (PPN) Feature","primary_completion_date":"2020-03-27","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-04-27","last_update":"2021-04-09","description":"Prospective, multi-center, randomized, controlled clinical trial to study the safety and effectiveness of a novel plasma collection system software.","other_id":"TP-CLN-100467","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"Triple","intervention_model_description":"Two-arm, randomized, controlled trial","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":66,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Donors must be qualified to donate plasma per individual site's screening procedures\r\n             which are in compliance with IQPP standards. If donors do not meet inclusion criteria\r\n             at subsequent donations but have already been enrolled in the clinical trial, they are\r\n             eligible to remain in the clinical trial and to donate plasma within the clinical\r\n             trial once they meet eligibility criteria again, except if they fulfill any of the\r\n             exclusion criteria listed below.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  All subjects meeting any of the exclusion criteria listed below will be permanently\r\n             excluded from the clinical trial.\r\n\r\n               -  Subject not able or willing to give consent to participate in the clinical trial.\r\n\r\n               -  Subject donated plasma outside of the present clinical trial after enrolling in\r\n                  this clinical trial.\r\n\r\n               -  Subjects are withdrawn from the clinical trial due to safety concerns by the\r\n                  qualified healthcare providers.\r\n\r\n               -  In addition, all donors for whom a BMI for use in the PPN feature cannot be\r\n                  reliably calculated will be excluded\r\n      ","sponsor":"Haemonetics Corporation","sponsor_type":"Industry","conditions":"Apheresis Related Hypotension","interventions":[{"intervention_type":"Device","name":"Device: Updated Plasma Collection Feature","description":"Plasma collection using a novel, patented system that supports a more individualized collection approach."},{"intervention_type":"Device","name":"Device: Current Plasma Collection Approach","description":"Plasma collection using the current collection approach."}],"outcomes":[{"outcome_type":"primary","measure":"Rate of Significant Hypotensive Adverse Events","time_frame":"Up to approximately 3 months (total trial duration during which donors could donate), depending on time of enrollment into the trial.","description":"The incidence rate of at least one significant hypotensive (vasovagal/hypovolemia) adverse event according to the plasma center adverse event reporting system, based on IQPP definitions of Signs/Symptoms/Findings.\r\nSignificant adverse events are defined as such events that fulfill the Signs/Symptoms/Findings of IQPP Donor Adverse Events (DAE) classifications 1.2 through 1.6 per the modified, symptoms-based approach following the plasma center adverse event reporting system.\r\nA Model Based Prediction method was used for this outcome."},{"outcome_type":"secondary","measure":"Rate of Severe Hypotensive Adverse Events","time_frame":"Up to approximately 3 months, depending on time of enrollment into the trial.","description":"Incidence rate of severe hypotensive (vasovagal/hypovolemia) adverse events according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings, per donation in donors undergoing plasmapheresis.\r\n*Only two severe (1.5) adverse events were observed: one in the experimental group and one in the control group. As the secondary analysis for severe hypotensive adverse events was to be conducted only if there were more than 2 severe hypotensive (vasovagal/hypovolemia) adverse events in any of the two study groups, no formal statistical analysis was performed."},{"outcome_type":"secondary","measure":"Rate of Significant Hypotensive Adverse Events Relative to Volume","time_frame":"Up to approximately 3 months, depending on time of enrollment into the trial.","description":"Incidence rate of significant hypotensive (vasovagal/hypovolemia) adverse events according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings, relative to the actual plasma volume collected.\r\n*The outcome is reported as the expected number of significant hypotensive adverse events per 10,000 L of collected plasma. This outcome was calculated using the total number of significant hypotensive adverse events and the total amount of plasma collected, then normalized to 10,000 L of collected plasma."},{"outcome_type":"secondary","measure":"Time From Start of Collection to First Significant Hypotensive Adverse Event","time_frame":"Up to approximately 3 months, depending on time of enrollment into the trial.","description":"Time from start of plasmapheresis \"Begin Draw\" to the first significant hypotensive (vasovagal/hypovolemia) adverse event according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings."},{"outcome_type":"secondary","measure":"Rate of Significant Hypotensive Adverse Events Relative to Bodyweight","time_frame":"Up to approximately 3 months, depending on time of enrollment into the trial.","description":"Incidence rate of significant hypotensive (vasovagal/hypovolemia) adverse events according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings, in the subgroups of donors with a bodyweight of less than or equal to 130 lbs and those greater than 130 lbs.\r\n*Note: Due to the absence of AE in the subgroup of donors with bodyweight of ≤130 lbs, no formal statistical analysis was performed."},{"outcome_type":"secondary","measure":"Rate of Significant Hypotensive Adverse Events Relative to BMI","time_frame":"Up to approximately 3 months, depending on time of enrollment into the trial.","description":"Incidence rate of significant hypotensive (vasovagal/hypovolemia) adverse events according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings, in the subgroups of donors with a body mass index (BMI) of less than or equal to 30 and of those greater than 30."},{"outcome_type":"secondary","measure":"Rate of Significant Hypotensive Adverse Events Relative to Donor Status","time_frame":"Up to approximately 3 months, depending on time of enrollment into the trial.","description":"Incidence rate of significant hypotensive (vasovagal/hypovolemia) adverse events according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings, in the subgroups of donors defined by their respective status as a first-time donor or repeat donor."},{"outcome_type":"secondary","measure":"Rate of Significant Hypotensive Adverse Events Relative to Gender","time_frame":"Up to approximately 3 months, depending on time of enrollment into the trial.","description":"Incidence rate of significant hypotensive (vasovagal/hypovolemia) adverse events according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings, in the subgroups of donors defined by their gender."},{"outcome_type":"secondary","measure":"Total Volume","time_frame":"Up to approximately 3 months, depending on time of enrollment into the trial.","description":"Total plasma volume collected per procedure."}]}
{"nct_id":"NCT03840525","start_date":"2020-01-06","phase":"Early Phase 1","enrollment":72,"brief_title":"A Mind Body Intervention to Reduce Symptoms Among People Aging With HIV","official_title":"A Mind Body Intervention to Reduce Symptoms Among People Aging With HIV","primary_completion_date":"2022-04-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-04-30","last_update":"2021-03-10","description":"This study will develop and pilot test a qigong intervention with older people (50 and over) living with HIV. Participants (n=72) will be randomly assigned to one of 3 conditions: the qigong intervention, a sham qigong intervention, and a usual standard of care group. The study will determine the acceptability and feasibility of the study. If found effective, the qigong intervention will also improve the psychological and physical symptoms of older people living with HIV.","other_id":"1R34AT009966-01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"Single","intervention_model_description":"The study will implement a 3 arm study including the qigong intervention, sham qigong intervention, and a treatment as usual condition","sampling_method":"","gender":"All","minimum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  50 year or older;\r\n\r\n          -  HIV+,\r\n\r\n          -  able to provide consent; and\r\n\r\n          -  willing to participate for the length of the intervention.\r\n\r\n        Exclusion criteria.\r\n\r\n          -  Participants who are unable to stand for 10-minute segments (i.e., wheelchair or\r\n             walker bound); and\r\n\r\n          -  participants who have substantial (regular weekly practice for more than 3 months in\r\n             the past 12 months) experience with mind-body interventions will be excluded because\r\n             the control group may be contaminated by prior experience.\r\n      ","sponsor":"Florida International University","sponsor_type":"Other","conditions":"Mental Health|Physical Health","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: The Qigong Intervention","description":"Qigong is a low-impact, slow-movement, meditative form of exercise that has helped relieve mental and physical stressors."},{"intervention_type":"Behavioral","name":"Behavioral: Sham Qigong","description":"This intervention includes similar body movements to qigong; however, it does not have the meditative or breath work."}],"outcomes":[{"outcome_type":"primary","measure":"Satisfaction with weekly Intervention Sessions","time_frame":"Assessments will be conducted once in Week 1","description":"Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction"},{"outcome_type":"primary","measure":"Satisfaction with weekly Intervention Sessions","time_frame":"Assessments will be conducted once in Week 2","description":"Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction"},{"outcome_type":"primary","measure":"Satisfaction with weekly Intervention Sessions","time_frame":"Assessments will be conducted once in Week 3","description":"Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction"},{"outcome_type":"primary","measure":"Satisfaction with weekly Intervention Sessions","time_frame":"Assessments will be conducted once in Week 4","description":"Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction"},{"outcome_type":"primary","measure":"Satisfaction with weekly Intervention Sessions","time_frame":"Assessments will be conducted once in Week 5","description":"Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction"},{"outcome_type":"primary","measure":"Satisfaction with weekly Intervention Sessions","time_frame":"Assessments will be conducted once in Week 6","description":"Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction"},{"outcome_type":"primary","measure":"Satisfaction with weekly Intervention Sessions","time_frame":"Assessments will be conducted once in Week 7","description":"Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction"},{"outcome_type":"primary","measure":"Satisfaction with weekly Intervention Sessions","time_frame":"Assessments will be conducted once in Week 8","description":"Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction"},{"outcome_type":"primary","measure":"Satisfaction with weekly Intervention Sessions","time_frame":"Assessments will be conducted once in Week 9","description":"Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction"},{"outcome_type":"primary","measure":"Satisfaction with weekly Intervention Sessions","time_frame":"Assessments will be conducted once in Week 10","description":"Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction"},{"outcome_type":"primary","measure":"Satisfaction with weekly Intervention Sessions","time_frame":"Assessments will be conducted once in Week 11","description":"Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction"},{"outcome_type":"primary","measure":"Satisfaction with weekly Intervention Sessions","time_frame":"Assessments will be conducted once in Week 12","description":"Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction"},{"outcome_type":"primary","measure":"Satisfaction with weekly home practice sessions","time_frame":"Assessments will be conducted once in Week 1","description":"Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction"},{"outcome_type":"primary","measure":"Satisfaction with weekly home practice sessions","time_frame":"Assessments will be conducted once in Week 2","description":"Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction"},{"outcome_type":"primary","measure":"Satisfaction with weekly home practice sessions","time_frame":"Assessments will be conducted once in Week 3","description":"Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction"},{"outcome_type":"primary","measure":"Satisfaction with weekly home practice sessions","time_frame":"Assessments will be conducted once in Week 4","description":"Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction"},{"outcome_type":"primary","measure":"Satisfaction with weekly home practice sessions","time_frame":"Assessments will be conducted once in Week 5","description":"Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction"},{"outcome_type":"primary","measure":"Satisfaction with weekly home practice sessions","time_frame":"Assessments will be conducted once in Week 6","description":"Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction"},{"outcome_type":"primary","measure":"Satisfaction with weekly home practice sessions","time_frame":"Assessments will be conducted once in Week 7","description":"Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction"},{"outcome_type":"primary","measure":"Satisfaction with weekly home practice sessions","time_frame":"Assessments will be conducted once in Week 8","description":"Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction"},{"outcome_type":"primary","measure":"Satisfaction with weekly home practice sessions","time_frame":"Assessments will be conducted once in Week 9","description":"Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction"},{"outcome_type":"primary","measure":"Satisfaction with weekly home practice sessions","time_frame":"Assessments will be conducted once in Week 10","description":"Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction"},{"outcome_type":"primary","measure":"Satisfaction with weekly home practice sessions","time_frame":"Assessments will be conducted once in Week 11","description":"Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction"},{"outcome_type":"primary","measure":"Satisfaction with weekly home practice sessions","time_frame":"Assessments will be conducted once in Week 12","description":"Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction"},{"outcome_type":"primary","measure":"Satisfaction with home practice sessions at 3 months","time_frame":"Assessments will be conducted at 3 months post intervention","description":"Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction"},{"outcome_type":"primary","measure":"Intervention Session Attendance (reported as percentages)","time_frame":"Assessments will be conducted once at Week 1","description":"The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance)."},{"outcome_type":"primary","measure":"Intervention Session Attendance (reported as percentages)","time_frame":"Assessments will be conducted once at Week 2","description":"The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance)."},{"outcome_type":"primary","measure":"Intervention Session Attendance (reported as percentages)","time_frame":"Assessments will be conducted once at Week 3","description":"The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance)."},{"outcome_type":"primary","measure":"Intervention Session Attendance (reported as percentages)","time_frame":"Assessments will be conducted once at Week 4","description":"The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance)."},{"outcome_type":"primary","measure":"Intervention Session Attendance (reported as percentages)","time_frame":"Assessments will be conducted once at Week 5","description":"The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance)."},{"outcome_type":"primary","measure":"Intervention Session Attendance (reported as percentages)","time_frame":"Assessments will be conducted once at Week 6","description":"The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance)."},{"outcome_type":"primary","measure":"Intervention Session Attendance (reported as percentages)","time_frame":"Assessments will be conducted once at Week 7","description":"The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance)."},{"outcome_type":"primary","measure":"Intervention Session Attendance (reported as percentages)","time_frame":"Assessments will be conducted once at Week 8","description":"The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance)."},{"outcome_type":"primary","measure":"Intervention Session Attendance (reported as percentages)","time_frame":"Assessments will be conducted once at Week 9","description":"The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance)."},{"outcome_type":"primary","measure":"Intervention Session Attendance (reported as percentages)","time_frame":"Assessments will be conducted once at Week 10","description":"The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance)."},{"outcome_type":"primary","measure":"Intervention Session Attendance (reported as percentages)","time_frame":"Assessments will be conducted once at Week 11","description":"The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance)."},{"outcome_type":"primary","measure":"Intervention Session Attendance (reported as percentages)","time_frame":"Assessments will be conducted once at Week 12","description":"The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance)."},{"outcome_type":"primary","measure":"Duration of weekly home practice sessions","time_frame":"Assessments will be conducted once at Week 1","description":"The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)"},{"outcome_type":"primary","measure":"Duration of weekly home practice sessions","time_frame":"Assessments will be conducted once at Week 2","description":"The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)"},{"outcome_type":"primary","measure":"Duration of weekly home practice sessions","time_frame":"Assessments will be conducted once at Week 3","description":"The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)"},{"outcome_type":"primary","measure":"Duration of weekly home practice sessions","time_frame":"Assessments will be conducted once at Week 4","description":"The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)"},{"outcome_type":"primary","measure":"Duration of weekly home practice sessions","time_frame":"Assessments will be conducted once at Week 5","description":"The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)"},{"outcome_type":"primary","measure":"Duration of weekly home practice sessions","time_frame":"Assessments will be conducted once at Week 6","description":"The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)"},{"outcome_type":"primary","measure":"Duration of weekly home practice sessions","time_frame":"Assessments will be conducted once at Week 7","description":"The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)"},{"outcome_type":"primary","measure":"Duration of weekly home practice sessions","time_frame":"Assessments will be conducted once at Week 8","description":"The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)"},{"outcome_type":"primary","measure":"Duration of weekly home practice sessions","time_frame":"Assessments will be conducted once at Week 9","description":"The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)"},{"outcome_type":"primary","measure":"Duration of weekly home practice sessions","time_frame":"Assessments will be conducted once at Week 10","description":"The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)"},{"outcome_type":"primary","measure":"Duration of weekly home practice sessions","time_frame":"Assessments will be conducted once at Week 11","description":"The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)"},{"outcome_type":"primary","measure":"Duration of weekly home practice sessions","time_frame":"Assessments will be conducted once at Week 12","description":"The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)"},{"outcome_type":"primary","measure":"Duration of home practice sessions at 3 months","time_frame":"Assessments will be conducted at 3 months post intervention","description":"The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)"},{"outcome_type":"primary","measure":"Frequency of home practice sessions","time_frame":"Assessments will be conducted once in Week 1","description":"The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)"},{"outcome_type":"primary","measure":"Frequency of home practice sessions","time_frame":"Assessments will be conducted once in Week 2","description":"The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)"},{"outcome_type":"primary","measure":"Frequency of home practice sessions","time_frame":"Assessments will be conducted once in Week 3","description":"The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)"},{"outcome_type":"primary","measure":"Frequency of home practice sessions","time_frame":"Assessments will be conducted once in Week 4","description":"The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)"},{"outcome_type":"primary","measure":"Frequency of home practice sessions","time_frame":"Assessments will be conducted once in Week 5","description":"The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)"},{"outcome_type":"primary","measure":"Frequency of home practice sessions","time_frame":"Assessments will be conducted once in Week 6","description":"The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)"},{"outcome_type":"primary","measure":"Frequency of home practice sessions","time_frame":"Assessments will be conducted once in Week 7","description":"The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)"},{"outcome_type":"primary","measure":"Frequency of home practice sessions","time_frame":"Assessments will be conducted once in Week 8","description":"The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)"},{"outcome_type":"primary","measure":"Frequency of home practice sessions","time_frame":"Assessments will be conducted once in Week 9","description":"The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)"},{"outcome_type":"primary","measure":"Frequency of home practice sessions","time_frame":"Assessments will be conducted once in Week 10","description":"The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)"},{"outcome_type":"primary","measure":"Frequency of home practice sessions","time_frame":"Assessments will be conducted once in Week 11","description":"The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)"},{"outcome_type":"primary","measure":"Frequency of home practice sessions","time_frame":"Assessments will be conducted once in Week 12","description":"The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)"},{"outcome_type":"primary","measure":"Frequency of home practice sessions at 3 months","time_frame":"Assessments will be conducted at 3 months post intervention","description":"The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)"},{"outcome_type":"primary","measure":"Will older people living with HIV still be practicing the intervention 3 months post intervention?","time_frame":"Assessments will be conducted at 3 months post intervention","description":"The investigators will also collect information on home practice sessions: how often did they practice, for how long were each practice session, satisfaction with the video and practice sessions three months post intervention."},{"outcome_type":"secondary","measure":"Change in Mental Health at 2 weeks post intervention","time_frame":"Assessments will be conducted at baseline, 2 weeks post intervention","description":"Mental Health will be assessed using the following standardized scale: the Depression Anxiety & Stress Scale (Ng, et al.; DASS-21 items). The DASS responses range from 0-3. The total score ranges from 0-42, with higher scores reflecting more severe symptoms"},{"outcome_type":"secondary","measure":"Change in Mental Health at 3 months post intervention","time_frame":"Assessments will be conducted at baseline, 3 months post intervention","description":"Mental Health will be assessed using the following standardized scale: the Depression Anxiety & Stress Scale (Ng, et al.; DASS-21 items). The DASS responses range from 0-3. The total score ranges from 0-42, with higher scores reflecting more severe symptoms"},{"outcome_type":"secondary","measure":"Change in Physical Health Status as measured by The Revised Sign & Symptom Check-List for HIV (Holzemer, et al.; 45 items) at 2 weeks post intervention","time_frame":"Assessments will be conducted at baseline, 2 weeks post intervention","description":"Physical Health will be assessed using the following standardized scale: The Revised Sign & Symptom Check-List for HIV (Holzemer, et al.; 45 items). The Symptoms Checklist total scores range from 0-135, with greater scores reflecting more symptoms."},{"outcome_type":"secondary","measure":"Change in Physical Health Status as measured by The Revised Sign & Symptom Check-List for HIV (Holzemer, et al.; 45 items) at 3 months post intervention","time_frame":"Assessments will be conducted at baseline, 3 months post intervention","description":"Physical Health will be assessed using the following standardized scale: The Revised Sign & Symptom Check-List for HIV (Holzemer, et al.; 45 items). The Symptoms Checklist total scores range from 0-135, with greater scores reflecting more symptoms."},{"outcome_type":"secondary","measure":"Change in Physical Health Status as measured by The HIV-related Fatigue Scale (Belza, et al.,16 items) at 2 weeks post intervention","time_frame":"Assessments will be conducted at baseline, 2 weeks post intervention","description":"Physical Health will be assessed using the following standardized scale: The HIV-related Fatigue Scale (Belza, et al.,16 items) . The total score for the Fatigue Scale ranges from 0-50, with greater scores reflecting more fatigue."},{"outcome_type":"secondary","measure":"Change in Physical Health Status as measured by The HIV-related Fatigue Scale (Belza, et al.,16 items) at 3 months post intervention","time_frame":"Assessments will be conducted at baseline, 3 months post intervention","description":"Physical Health will be assessed using the following standardized scale: The HIV-related Fatigue Scale (Belza, et al.,16 items) . The total score for the Fatigue Scale ranges from 0-50, with greater scores reflecting more fatigue."}]}
{"nct_id":"NCT04478968","start_date":"2020-01-03","enrollment":150,"brief_title":"Approach to Vascular Access After Renal Transplantation","official_title":"The Levels of Fibrosis Biomarkers in Patients After Renal Transplantation in Relation to Arteriovenous Fistula Function","primary_completion_date":"2022-01-02","study_type":"Observational","rec_status":"Recruiting","completion_date":"2022-01-02","last_update":"2020-07-21","description":"The aim of the project is to assess the effect of functioning AVF in renal transplant patients on fibrosis, inflammation and LVH indicators. Clinical and laboratory parameters will be compared in a group of 150 patients, 75 patients with a functioning fistula and 75 patients with inactive vascular access. We will assess the impact of functional AVF and the levels of biomarkers on the survival of patients and transplanted kidneys.","other_id":"MINI.C160.20.001","observational_model":"Cohort","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients who have had a kidney transplant belong to the group of patients at increased risk\r\n        for cardiovascular disease.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  age> 18 years old\r\n\r\n          -  kidney transplant\r\n\r\n          -  >12 months after transplantation\r\n\r\n          -  stable transplanted kidney function\r\n\r\n          -  signed informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  GFR <15 ml / min\r\n\r\n          -  severe infection within 3 months of testing\r\n\r\n          -  increase in creatinine concentration> 0.5 mg / dl within 3 months before the test\r\n\r\n          -  active cancer\r\n\r\n          -  signs of severe heart failure (NYHA IV)\r\n      ","sponsor":"Wroclaw Medical University","sponsor_type":"Other","conditions":"Kidney Transplantation","interventions":[{"intervention_type":"Other","name":"Other: presence of AVF","description":"Functioning AVF may have cardiotoxic potential"}],"outcomes":[{"outcome_type":"primary","measure":"Quality of life with EQ-5D-5L","time_frame":"Baseline visit up to 12 months","description":"The survey results will be compared between the study and control groups to see if the presence of the arteriovenous fistula affects quality of life."},{"outcome_type":"primary","measure":"Prognostic value of biomarkers (NT-proBNP, Il-6, sST2, galectin-3, GDF-15, MMP7, TIMP1)","time_frame":"Baseline visit and up to 12 months","description":"The levels of biomarkers will be measured and the results will be compared between the study and control groups. A prognostic value of the biomarkers will be estimated."},{"outcome_type":"secondary","measure":"Hospitalization-free survival","time_frame":"Up to 12 months from baseline visit","description":"Hospital-free survival will be reported as the number of patients living 12 months after the initial visit without the need for hospitalization."}]}
{"nct_id":"NCT04462523","start_date":"2020-01-03","phase":"Phase 4","enrollment":40,"brief_title":"DEXTENZA for the Treatment of Postoperative Pain and Inflammation Following Vitreo-retinal Surgery","official_title":"Open-label, Single -Center, Prospective Study on the Efficacy and Safety of Intracanalicular Dexamethasone Insert 0.4mg (Dextenza) in the Treatment of Postoperative Pain and Inflammation Following Vitreo-retinal Surgery - The ADHERE Study","primary_completion_date":"2020-10-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2020-12-31","last_update":"2020-07-08","description":"The purpose of this study is to evaluate efficacy and safety of Dextenza for the treatment of postoperative pain and inflammation following vitreo-retinal surgery","other_id":"The ADHERE Study","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Any adult patient age 18-99 years who is planned to undergo vitreo-retinal surgery\r\n             (pars plana vitrectomy with or without scleral buckle).\r\n\r\n          -  If both eyes are involved, both eyes would be eligible for the study.\r\n\r\n          -  Willing and able to comply with clinic visits and study related procedures.\r\n\r\n          -  Willing and able to sign the informed consent form.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients under age 18.\r\n\r\n          -  Patients who are pregnant (must be ruled out in women of child-bearing age with\r\n             pregnancy test).\r\n\r\n          -  Active infectious ocular or systemic disease.\r\n\r\n          -  Patients with active infectious ocular or extraocular disease.\r\n\r\n          -  Patients actively treated with local or systemic immunosuppression\r\n\r\n          -  Use of the following anti-inflammatory or immunomodulating agents (e.g., cyclosporine)\r\n             systemically, or in the study eye, for the duration of the study (excluding\r\n             inhalants). Washout periods for medications prior to surgery are as follows:\r\n\r\n          -  Systemic corticosteroids - 2 weeks (see exception 5c)\r\n\r\n          -  Systemic NSAID over 375 mg per day - 2 weeks\r\n\r\n          -  Periocular/intraocular injection of any corticosteroid solution - 4 weeks (see\r\n             exception 5b)\r\n\r\n          -  Corticosteroid depot/implant in the study eye - 2 months\r\n\r\n          -  Topical ocular corticosteroid - 7 days\r\n\r\n          -  Topical ocular NSAID - 7 days\r\n\r\n          -  Intraoperatively used intraocular steroid (i.e. intravitreal triamcinolone, that is\r\n             used to transiently highlight the vitreous and removed during vitrectomy) is\r\n             permissible in study eye.\r\n\r\n          -  Intraoperatively or perioperatively used systemic steroid for the purpose of general\r\n             anesthesia (as administered by the treating anesthesiologist) is permissible.\r\n\r\n          -  Patients with systemic illness involving abnormalities of the\r\n             hypothalamic-pituitary-adrenal axis; patients with primary adrenocortical\r\n             insufficiency or adrenocortical hyperfunction.\r\n\r\n          -  Patients with known hypersensitivity to Dexamethasone.\r\n\r\n          -  Patients with uncontrolled glaucoma.\r\n\r\n          -  Patients with severe disease that warrants critical attention, deemed unsafe for the\r\n             study by the investigator.\r\n      ","sponsor":"Patrick R. Oellers, MD","sponsor_type":"Other","conditions":"Vitreo-Retinal Surgery","interventions":[{"intervention_type":"Drug","name":"Drug: Dextenza 0.4Mg Ophthalmic Insert","description":"The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion. The attributes of the insert reduce the risks for improper corticosteroid tapering and unwanted peaks and troughs in drug concentration."},{"intervention_type":"Drug","name":"Drug: Topical Prednisolone","description":"Standard of care topical drop treatment"}],"outcomes":[{"outcome_type":"primary","measure":"Mean cells as assessed by investigator in anterior chamber of the study eye","time_frame":"Assessed at Day 14","description":"As measure by Standardization of Uveitis Nomenclature (SUN Scale) (Grade 0 to Grade 4+)"},{"outcome_type":"primary","measure":"Mean pain as reported by subject in the study eye: Visual Analog Scale","time_frame":"Assessed at Day 28","description":"As measured by Visual Analog Scale for Pain (VAS Pain) (0% to 100% Scale)"},{"outcome_type":"secondary","measure":"Mean anterior chamber flare","time_frame":"Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56","description":"As measure by Standardization of Uveitis Nomenclature (SUN Scale) (Grade 0 to Grade 4+)"},{"outcome_type":"secondary","measure":"Time to absence of cells","time_frame":"Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56","description":"As measure by Standardization of Uveitis Nomenclature (SUN Scale) (Grade 0 to Grade 4+)"},{"outcome_type":"secondary","measure":"Time to absence of pain","time_frame":"Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56","description":"As measure by Visual Analog Scale for Pain (VAS Pain) (0% to 100% Scale)"},{"outcome_type":"secondary","measure":"Proportion of rescue treatment","time_frame":"Assessed at Screening, Day 1, Day 4, Day 14, Day 28 and Day 56","description":"As measure by Concomitant Medications as rescue therapy"},{"outcome_type":"secondary","measure":"Assessment of Dextenza ease of insertion","time_frame":"Assessed at Day 1","description":"As measured by Ease of Use Survey (0=very easy to 10=very hard)"}]}
{"nct_id":"NCT04574167","start_date":"2020-01-01","phase":"N/A","enrollment":120,"brief_title":"Effects of tDCS Paired With Cognitive Training on Brain Networks Associated With Alcohol Use Disorder in Veterans","official_title":"Effects of tDCS Paired With Cognitive Training on Brain Networks Associated With Alcohol Use Disorder in Veterans","primary_completion_date":"2023-09-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-12-31","last_update":"2021-04-22","description":"Alcohol misuse is an epidemic among Veterans in the United States. Nearly 1/3 of Veterans have a lifetime history of Alcohol Use Disorder (AUD). In 2014, there were 15,306 unique patients treated in inpatient VA treatment programs alone, which represents a 10.7% increase from just two years prior. Unfortunately, about 2/3 of those entering treatment will relapse within one year. Cognitive impairments found in chronic alcohol use interfere with adaptive behavior needed for successful recovery. However, these cognitive impairments and their underlying neural substrates may provide promising new targets for interventions that can reduce relapse rates. Evidence suggests that cognitive training can improve cognition in individuals with AUD, strengthen neural networks mediating cognition, and improve treatment outcome. However, cognitive training is effort intensive, has small effect sizes, and may have limited durability. The primary objective of this study is to investigate if transcranial direct current stimulation (tDCS) can increase the effectiveness of cognitive training to enhance cognition in alcohol use disorder and improve treatment outcome.","other_id":"MHBB-011-19S","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Veterans receiving services through the MVAHCS\r\n\r\n          -  Current diagnosis of Alcohol Use Disorder according to DSM-5\r\n\r\n          -  Abstinent from alcohol use for at least one week (i.e., not in acute withdrawal)\r\n\r\n          -  Men and women 18-65 years of age\r\n\r\n          -  Stable on any medications in the judgement of the PI at baseline\r\n\r\n          -  Capable and willing to provide voluntary informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Current (within one month of enrollment) stimulant dependence based on clinical\r\n             history\r\n\r\n          -  Significant neurological disorder or insult that would impact risk (based on the\r\n             principal investigator's judgement and research literature)\r\n\r\n          -  Cognitive impairment as indicated by a score lower than or equal to 20 on the Montreal\r\n             Cognitive Assessment (MoCA) or determined by the PI's judgement\r\n\r\n          -  Current active psychosis and mania\r\n\r\n          -  Significant suicide risk as indicated by MINI Interview\r\n\r\n          -  Contraindications for tDCS (e.g., metallic cranial plates/screws or implanted device,\r\n             eczema or skin lesions on scalp)\r\n\r\n          -  Contraindications for MRI (e.g., unapproved metallic implants, pacemakers or any other\r\n             implanted electrical device, shrapnel, metallic braces, non-removable body piercings,\r\n             significant breathing or movement disorder, claustrophobia)\r\n\r\n          -  Positive pregnancy report in women of childbearing age/potential\r\n      ","sponsor":"VA Office of Research and Development","sponsor_type":"U.S. Fed","conditions":"Alcohol Use Disorder","interventions":[{"intervention_type":"Device","name":"Device: Active Transcranial Direct Current Stimulation (tDCS)","description":"Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the left frontal cortex for 20 minutes."},{"intervention_type":"Device","name":"Device: Sham Transcranial Direct Current Stimulation (tDCS)","description":"Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning and end of session)."}],"outcomes":[{"outcome_type":"primary","measure":"Differences in change in frontal-striatal functional connectivity","time_frame":"Change between baseline and post-intervention (3 week) follow-up","description":"Participants will complete MRI sessions on a 3T scanner located in the Center for Magnetic Resonance Research (CMRR) at the University of Minnesota. Participants will undergo resting-state MRI over a 12-minute scan in order to gather resting state functional connectivity (RSFC). Hierarchical linear models will examine differences in change in target engagement (frontal-striatal RSFC) between active and sham tDCS conditions."},{"outcome_type":"primary","measure":"Change in Trail Making Test (TMT) score","time_frame":"Change between baseline and post-intervention (3 week) follow-up; 1 and 2 months following intervention","description":"The TMT is a neuropsychological test of visual attention and task switching. The test consists of two parts in which the participant is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The test can provide information about visual search speed, scanning, speed of processing, mental flexibility and executive functioning."},{"outcome_type":"primary","measure":"Change in Stroop Color-Word Test (SCWT) score","time_frame":"Change between baseline and post-intervention (3 week) follow-up; 1 and 2 months following intervention","description":"The SCWT is a neuropsychological test of the ability to inhibit cognitive interference which occurs when the processing of a stimulus feature affects the simultaneous processing of another attribute of the same stimulus."},{"outcome_type":"primary","measure":"Change in binge drinking days per week as measured using the Timeline Followback questionnaire","time_frame":"Change between baseline and post-intervention (3 week) follow-up; 1 and 2 months following intervention","description":"The TLFB questionnaire measures substance use disorder severity. The questionnaire asks the participant about substance use in the past 30 days. The participant reports on a binary scale as to whether or not they have used a given substance. Binge drinking is defined as men consuming 5 or more drinks or women consuming 4 or more drinks in about 2 hours."}]}
{"nct_id":"NCT04404244","start_date":"2020-01-01","enrollment":100,"brief_title":"Extraordinary Measures for Egyptian Children With Hemato-Oncological Disorders During COVID-19 Pandemic","official_title":"Extraordinary Measures for Egyptian Children With Hemato-Oncological Disorders During COVID-19 Pandemic","primary_completion_date":"2022-01-01","study_type":"Observational","rec_status":"Recruiting","completion_date":"2022-06-01","last_update":"2021-04-20","description":"This is a prospective follow-up non-intervention study that will be carried out at Hematology/ Oncology Department, Children's hospital, Ain-Shams University, Cairo, Egypt. All followed-up children below 18 years with cancer during the one year study period from May 2020 till Apr 2021 either at the out-patients clinic or inpatient department will be recruited.","other_id":"FMASU P25a/ 2020","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","maximum_age":18,"population":"All followed-up children below 18 years with with malignancy either hematological or solid\r\n        tumors or hematological condition during the one year study period from May 2020 till Apr\r\n        2021 either at the out-patients clinic or inpatient department will be recruited.","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Children below 18 years with malignancy either hematological or solid tumors or\r\n\r\n          2. Children below 18 years with hematological condition\r\n\r\n        Exclusion Criteria:\r\n\r\n        1. Patients or care-givers refusal to be enrolled in the study\r\n      ","sponsor":"Fatma Soliman Elsayed Ebeid","sponsor_type":"Other","conditions":"Coronavirus COVID-19","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Incidence of COVID-19 among children with cancer","time_frame":"12 months","description":"Measure the incidence of COVID-19 infection among children with cancer"},{"outcome_type":"secondary","measure":"Families training","time_frame":"12 months","description":"Families training about adhering to standard precautions for basic and respiratory hygiene to reduce the risk of transmission"}]}
{"nct_id":"NCT04267341","start_date":"2020-01-01","enrollment":45,"brief_title":"Effect of Dual Task on Upper and Lower Extremity Skills in Parkinson's Disease","official_title":"Examining The Change of Upper and Lower Extremity Skills With The Effect of Dual Task in Parkinson's Disease Patients","primary_completion_date":"2020-03-15","study_type":"Observational [Patient Registry]","rec_status":"Completed","completion_date":"2020-08-01","last_update":"2020-12-03","description":"The aim of the study is to investigate the change of lower and upper extremity skills with dual task in Parkinson's disease patients and to determine the differences between Parkinson's disease patients with different stages of disease and the healthy controls regarding the change of lower and upper extremity skills with dual task.","other_id":"2019/24-01","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":40,"population":"Patients with Parkinson's Disease who apply to the Hacettepe University, Faculty of\r\n        Physiotherapy and Rehabilitation, Department of Neurological Rehabilitation will be invited\r\n        to this study.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Modified Hoehn & Yahr (H&Y) stages 1 to 3\r\n\r\n          -  at least 40 years of age\r\n\r\n          -  21 or more MoCA score.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  other neurologic disorder\r\n\r\n          -  any orthopedic problem that could prevent to participate in the study\r\n\r\n          -  severe dyskinesia or tremor\r\n\r\n          -  visual or speech problems\r\n      ","sponsor":"Hacettepe University","sponsor_type":"Other","conditions":"Parkinson Disease|Movement Disorders","interventions":[{"intervention_type":"Other","name":"Other: Timed Up and Go Test","description":"It requires individual to stand up from an armed chair, walk 3m, turn around, walk back to the armed chair, and sit down again"},{"intervention_type":"Other","name":"Other: 10 Meter Walk Test","description":"10 Meter Walk Test measures the time required to complete straight walk of 10 meters distance"},{"intervention_type":"Other","name":"Other: Purdue Pegboard Test","description":"Purdue Pegboard test evaluates the fine manuel dexterity"}],"outcomes":[{"outcome_type":"secondary","measure":"Short-Form 8-Item Parkinson's Disease Questionnaire (PDQ-8)","time_frame":"1-2 minutes","description":"The short-form 8-item Parkinson's disease Questionnaire (PDQ-8) is the most commonly used scale measuring health related quality of life (HRQoL) in PD patients. It includes 8 items, and each item has five options (never, occasionally, sometimes, often, always or cannot do at all). The total score ranges from 0 to 32. Higher scores indicates poorer quality of life."},{"outcome_type":"primary","measure":"Timed Up and Go Test","time_frame":"10-15 seconds","description":"Functional mobility is assessed by using the timed up and go test. The timed up and go test measures the time that a patient needs to stand up from a chair, walk a 3-m distance, come back and sit back on the chair."},{"outcome_type":"primary","measure":"10 Meter Walk Test","time_frame":"10-15 seconds","description":"10 Meter Walk Test measures the time required to complete straight walk of 10 meters distance."},{"outcome_type":"primary","measure":"Purdue Pegboard Test","time_frame":"3-5 minutes","description":"Purdue Pegboard Test assesses the speed and motor dexterity of each hand and the manual dexterity using both hands at the same time. The PPT consists of a board with two columns with 25 holes each and a specific number of pins, washers and collars placed in four containers across the top of the board."},{"outcome_type":"secondary","measure":"Modified Hoehn and Yahr Scale","time_frame":"1 minute","description":"Modified Hoehn and Yahr Scale allocates stages from 0 to 5 to indicate the relative level of disability and stage of disease. Higher level indicates worse physical condition."},{"outcome_type":"secondary","measure":"Montreal Cognitive Assessment (MoCA)","time_frame":"10-15 minutes","description":"Montreal Cognitive Assessment (MoCA) will be used in order to evaluate cognition. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.It' score ranged from 0 to 30 and higher points indicates better cognitive outcomes."}]}
{"nct_id":"NCT04725526","start_date":"2020-01-01","phase":"N/A","enrollment":236,"brief_title":"Efficiency of an mHealth Intervention on the Health Literacy Improvement and Self-management.","official_title":"Development and Efficiency of an mHealth Intervention on the Health Literacy Improvement and Self-management of the Multi-pathological Patient With Heart Failure: a Randomized Controlled Trial.","primary_completion_date":"2023-01-01","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2024-01-01","last_update":"2021-02-05","description":"Multipathological patients with complex health needs are responsible for the majority number of avoidable hospital admissions. The expansion of mHealth interventions in the field of communication with the patient, the reduction of health inequalities, the improvement in access to health resources, the adherence to treatments and self-care of chronic diseases lead to an optimistic horizon . However, there are few applications that demonstrate its effectiveness in these patients, which is diminished when they are not based on evidence, nor are designed by and for users with different levels of health literacy.","other_id":"PBS-MHE-2019","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients of both sexes and over 18 years of age;\r\n\r\n          -  Attended by the health professionals of the Basic Health Areas that are participating\r\n             in the study;\r\n\r\n          -  Patients that give their consent to participate in the study by signing an informed\r\n             consent;\r\n\r\n          -  Patients that have a mobile device (Smartphone or Tablet) compatible with the Android\r\n             or iOS operating system;\r\n\r\n          -  Patients considered as multi-pathological based on the following criteria from those\r\n             described in the Integrated Healthcare Process (Ollero et al., 2018):\r\n\r\n          -  Be classified in clinical category A of chronic pathologies due to heart failure that,\r\n             in a situation of clinical stability, has been in NYHA grade II, being able to be\r\n             simultaneously classified, or not, in other clinical categories due to suffering from\r\n             another disease Chronicles.\r\n\r\n          -  Patients with at least one of the following complexity criteria: Extreme polypharmacy\r\n             (10 or more active ingredients for chronic prescription); Socio-family risk (score on\r\n             the Gijon scale greater than 10 points); Stage II or higher pressure ulcers;\r\n             Malnutrition (BMI <18.5); Feeding with chronic and prescription tube (3 or more\r\n             months); Two or more hospital admissions in the previous 12 months.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with sensory deficits and/or mobility problems in the upper limbs that\r\n             prevent them from using the application correctly, despite using the accessibility\r\n             features of mobile devices;\r\n\r\n          -  Patients with persistent cognitive impairment (Pfeiffer test with 5 or more errors or\r\n             Lobo's mini-cognitive exam <23 points) and / or severe mental disorder;\r\n\r\n          -  Patients with serious limitations for AVBD (Barthel index <20 points).\r\n      ","sponsor":"Instituto de investigacin e innovacin biomdica de Cdiz","sponsor_type":"Other","conditions":"Heart Failure|Multi-pathology","interventions":[{"intervention_type":"Device","name":"Device: Mobile phone compatible with iOS or Android","description":"MHealth (mobile health) intervention is an act whose purpose is to improve, maintain, promote or modify health, functioning or health conditions."}],"outcomes":[{"outcome_type":"primary","measure":"Health literacy","time_frame":"1 year","description":"Literacy on health defined by points (range 0-50)"},{"outcome_type":"primary","measure":"General selfmanagement","time_frame":"1 year","description":"Selfmanagement on health (scale 1-5)"},{"outcome_type":"primary","measure":"selfmanagement on heart failure","time_frame":"1 year","description":"European Heart Failure SelfCare Behavior Scale (range 12-60)"},{"outcome_type":"secondary","measure":"self-independence","time_frame":"1 year","description":"Personal grade of self-independence- Barthel Index"},{"outcome_type":"secondary","measure":"self-independence 2","time_frame":"1 year","description":"Personal grade of self-independence- Lawton and Brody Index"},{"outcome_type":"secondary","measure":"Adherence to treatments","time_frame":"1 year","description":"Adherence to treatments measured by Morisky-Green Questionnaire"},{"outcome_type":"secondary","measure":"Prognosis","time_frame":"1 year","description":"Life prognosis using PROFUND Index"},{"outcome_type":"secondary","measure":"Patient satisfaction","time_frame":"1 year","description":"General patient satisfaction using a simple questionnarie"},{"outcome_type":"secondary","measure":"Patient satisfaction 2","time_frame":"1 year","description":"Patients satisfaction related to mHealth device"}]}
{"nct_id":"NCT04417582","start_date":"2020-01-01","enrollment":1000,"brief_title":"Life Style Modification Medical and Surgical Management in Patients With Obesity","official_title":"Evaluation of Life Style Modification Medical and Surgical Treatment Modalities in Patients With Obesity: An Observational Study","primary_completion_date":"2023-12-01","study_type":"Observational [Patient Registry]","rec_status":"Recruiting","completion_date":"2025-12-01","last_update":"2020-06-04","description":"In this is an observational study, obese patients that administed and followed in endocrinology clinic of Marmara University Medical school hospital will follow for clinical and laboratory parameters prospectively for 5 years","other_id":"09.2019.948","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":65,"population":"obese patients refered to our tertiary center for obesity evaluation or treatment","criteria":"\n        Inclusion Criteria:\r\n\r\n        Body mass index over 30 kg/m2 age between 18-65 years\r\n\r\n        Exclusion Criteria:\r\n\r\n        active malignancy pregnancy during involvement period chronic inflamatuar diseases\r\n      ","sponsor":"Marmara University","sponsor_type":"Other","conditions":"Obesity|Weight Change, Body|Obesity; Endocrine|Obesity, Metabolically Benign","interventions":[{"intervention_type":"Procedure","name":"Procedure: bariatric surgey","description":"patients undergone bariatric surgery or prescribed antiobesity drugs"}],"outcomes":[{"outcome_type":"primary","measure":"weight loss","time_frame":"6 months interval","description":"%5-10 weight loss"},{"outcome_type":"primary","measure":"metabolic improvement","time_frame":"6 months interval","description":"blood glucose"},{"outcome_type":"primary","measure":"metabolic improvement","time_frame":"6 month","description":"serum lipid levels"}]}
{"nct_id":"NCT04342819","start_date":"2020-01-01","phase":"Phase 2/Phase 3","enrollment":25,"brief_title":"The Effect of empagliFlozin on Platelet Function profilEs in diabetiC patienTs - The EFFECT Study.","official_title":"The Effect of empagliFlozin on Platelet Function profilEs in diabetiC patienTs - The EFFECT Study.","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-12-31","last_update":"2020-04-13","description":"The mechanistic effects of empagliflozin on platelet function profiles have not yet been ascertained.","other_id":"CREC-SA.0054/10/2019","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","intervention_model_description":"The study will be of a prospective, single-arm, crossover trial design over a 2-year period. Patients at the Eric Williams Medical Sciences Complex (EWMSC), Mt. Hope, Trinidad and Tobago.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. between 18 and 74 years of age,\r\n\r\n          2. have stable coronary artery disease and diabetes mellitus, already on DAPT with\r\n             aspirin and clopidogrel for at least 6 months,\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. presence of active internal bleeding or history of bleeding diathesis or clinical\r\n             findings associated with an increased risk of bleeding,\r\n\r\n          2. history of ischemic or hemorrhagic stroke, transient ischemic attack, intracranial\r\n             neoplasm, arteriovenous malformation, or aneurysm,\r\n\r\n          3. history of clinical and/or hemodynamic instability,\r\n\r\n          4. within 1 month of placement of a bare metal stent,\r\n\r\n          5. within 30 days of coronary artery bypass graft surgery or PCI without a stent placed,\r\n\r\n          6. planned coronary revascularization,\r\n\r\n          7. treatment with fibrin-specific fibrinolytic therapy <24 h or non-fibrin-specific\r\n             fibrinolytic therapy <48 h,\r\n\r\n          8. use of an oral anticoagulation agent or international normalized ratio >1.5,\r\n\r\n          9. body weight <60 kg,\r\n\r\n         10. age >75 years,\r\n\r\n         11. hemoglobin <10 g/dL,\r\n\r\n         12. platelet count <100106/L,\r\n\r\n         13. creatinine >2 mg/dL,\r\n\r\n         14. hepatic enzymes >2.5 times the upper limit of normal,\r\n\r\n         15. pregnancy and/or lactation.\r\n      ","sponsor":"The University of The West Indies","sponsor_type":"Other","conditions":"Platelet Dysfunction Due to Drugs","interventions":[{"intervention_type":"Drug","name":"Drug: SGLT2 inhibitor","description":"Sodium-Glucose Like Transporter 2 Inhibitor"}],"outcomes":[{"outcome_type":"primary","measure":"Platelet Reaction Units","time_frame":"14 days","description":"Platelet Reaction Units post-Empagliflozin"}]}
{"nct_id":"NCT04243694","start_date":"2020-01-01","phase":"N/A","enrollment":0,"brief_title":"Sustainable Mindfulness and Resilience Training (SMART)","official_title":"Sustainable Mindfulness and Resilience Training (SMART)","primary_completion_date":"2020-07-01","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2020-07-01","last_update":"2021-01-20","description":"Investigators are proposing a 6-week mindfulness and resilience training intervention tailored for caregivers of children with autism. Investigators will assess increases the caregiver's well-being and levels of psychological acceptance of their life situation as it relates to their child with autism. The mindfulness training focuses on self-regulation of emotional responses and acceptance of internal experiences. Self-report measures and qualitative interviews will be administered at baseline and post-intervention. Investigators will compare the active group to a control group of caregivers who are on the waitlist to receive the intervention.","other_id":"19-27771","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age 20-60 years old\r\n\r\n          -  Full time caregiver for a child with ASD, aged 3 to 12\r\n\r\n          -  Child diagnosed with ASD for a minimum of 6 months\r\n\r\n          -  English Speaking\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any conditions that may make it difficult to participate in a mindfulness group (e.g.,\r\n             psychotic disorder, personality disorder)\r\n      ","sponsor":"University of California, San Francisco","sponsor_type":"Other","conditions":"Caregiver Stress|Autism Spectrum Disorder","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Mindfulness training","description":"Participants of the intervention group will receive 6-weeks of mindfulness training."}],"outcomes":[{"outcome_type":"primary","measure":"Acceptance of child's diagnosis: Acceptance of Diagnosis of Autism-modified scale","time_frame":"6 weeks","description":"Measured by the Acceptance of Diagnosis of Autism-modified scale (example item \"I have a greater acceptance of my child's challenges than I used to.\")"},{"outcome_type":"primary","measure":"Acceptance of one's negative experiences (experiential avoidance, negative emotions and thoughts): Acceptance and Action Questionnaire","time_frame":"6 weeks","description":"Measured by the Acceptance and Action Questionnaire (example item rating on a scale \"I'm afraid of my feelings\", the Brief Experiential Avoidance Questionnaire (measures intentional avoidance of thoughts, feelings and experiences associated with distress), and the Self Compassion Scale (measures the degree to which individuals display self-kindness against self-judgment, common humanity versus isolation, and mindfulness versus over-identification)."},{"outcome_type":"primary","measure":"Acceptance of one's momentary situation as assessed by daily mind states (mind wandering, rejection vs. engagement in current moment): daily diary assessments","time_frame":"6 weeks","description":"Measured by daily diary assessments"}]}
{"nct_id":"NCT03598478","start_date":"2020-01-01","phase":"N/A","enrollment":156,"brief_title":"Tai Chi-muscle Power Training for Primary School Children With Developmental Coordination Disorder","official_title":"Tai Chi-muscle Power Training for Primary School Children With Developmental Coordination Disorder: A Randomized Controlled Trial","primary_completion_date":"2022-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-12-31","last_update":"2019-10-14","description":"Objectives: To compare the effectiveness of Tai Chi-muscle power training (TC-MPT), Tai Chi (TC) alone, muscle power training (MPT) alone, and usual care (as a control) for improving the limits of stability (LOS) of balance control in children with developmental coordination disorder (DCD) and to explore the relationship among LOS, falls, and functional performance in this population. Design: A randomized controlled trial. Sample: 156 children with DCD. Interventions: TC-MPT, TC alone, MPT alone, or usual care for 12 weeks. Major outcomes: Outcomes will be evaluated at baseline, post-intervention, and a 3-month follow-up. An LOS test will give a dynamic LOS score, an isokinetic test will quantify leg muscle force production speed, Movement Assessment Battery for Children-2 will be used to assess functional motor performance, and fall history will be obtained via interviews. Anticipated results and significance: The TC-MPT group is predicted to display the best LOS balance performance, which is associated with reduced fall incidents and improved functional performance. This novel training regime could be readily adopted into school or clinical settings to improve physical well-being in children with DCD, an outcome with positive socioeconomic implications.","other_id":"002","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":9,"maximum_age":12,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        9- to 12-years-old\r\n\r\n        Classified as DCD according to the Diagnostic and Statistical Manual of Mental Disorders V\r\n        (DSM-5)\r\n\r\n        A percentile score of < 5th percentile on the MABC-2\r\n\r\n        A total score of < 55 (for children aged 8 to 9 years 11 months) or < 57 (for children aged\r\n        10 or above) on the DCD questionnaire 2007 (Chinese version)\r\n\r\n        Attending a mainstream primary school (i.e., intelligence level within the normal range)\r\n\r\n        Exclusion Criteria:\r\n\r\n        Any known significant congenital, cognitive, psychiatric (other than comorbid attention\r\n        deficit hyperactivity disorder [ADHD] or autism spectrum disorder [ASD]), neurological,\r\n        sensory, musculoskeletal, or cardiopulmonary disorder that may affect motor performance\r\n\r\n        Receiving active treatment such as physiotherapy\r\n\r\n        Demonstrating excessive disruptive behavior during the assessments\r\n\r\n        Those unable to follow instructions properly\r\n      ","sponsor":"The University of Hong Kong","sponsor_type":"Other","conditions":"Developmental Coordination Disorder","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: TC-MPT","description":"Participants will receive two levels of training within each 90-minute session over a 12-week period: (1) TC training and (2) MPT. The TC training protocol consists of five basic TC movements. After receiving TC training, the participants in this group will take a 5-minute break and then receive MPT. During MPT, the participants will contract their major postural muscles bilaterally as fast as possible against a resistance equivalent to 70% of one repetition maximum."},{"intervention_type":"Behavioral","name":"Behavioral: TC","description":"Children in the TC group will skip the MPT session and practice TC movements repeatedly for 90 minutes. The exercise progression pattern in the TC-alone group will be the same as that in the TC-MPT group."},{"intervention_type":"Behavioral","name":"Behavioral: MPT","description":"Those children in the MPT group will perform strengthening exercises repeatedly for 90 minutes, with a short 5-minute break between the three sets of exercises if necessary. The exercise progression pattern in the MPT-alone group will be the same as that in the TC-MPT group."}],"outcomes":[{"outcome_type":"secondary","measure":"Change of leg muscle force production speed","time_frame":"0, 3, 6 months","description":"Isokinetic/ hand-held dynamometry: time taken to reach peak torque of the knee flexor and extensor muscles"},{"outcome_type":"secondary","measure":"Change of leg muscle strength","time_frame":"0, 3, 6 months","description":"Isokinetic/ hand-held dynamometry: peak torque of the knee flexor and extensor muscles"},{"outcome_type":"secondary","measure":"Change of fall history","time_frame":"0, 3, 6 months","description":"Self-reported and parent-reported falls"},{"outcome_type":"primary","measure":"Change of limits of stability","time_frame":"0, 3, 6 months","description":"Computerized dynamic posturography - A dynamic limits of stability score (%), from 0-100%. A higher score represents a greater limits of stability (better)."},{"outcome_type":"primary","measure":"Change of center of gravity control","time_frame":"0, 3, 6 months","description":"Computerized dynamic posturography - time to complete the DLOS test (sec)"},{"outcome_type":"secondary","measure":"Change of functional motor performance (raw data)","time_frame":"0, 3, 6 months","description":"Movement Assessment Battery for Children-2 total test score"},{"outcome_type":"secondary","measure":"Change of functional motor performance (compared to norm)","time_frame":"0, 3, 6 months","description":"Movement Assessment Battery for Children-2 total percentile rank (from 0-100 percentile). A higher percentile represents better functional motor performance."}]}
{"nct_id":"NCT04207242","start_date":"2020-01-01","enrollment":1520,"brief_title":"Social Media Use of Psoriasis Vulgaris Patients: Multicenter, Survey Work","official_title":"Social Media Use of Psoriasis Vulgaris Patients: Multicenter, Survey Work","primary_completion_date":"2020-01-01","study_type":"Observational","rec_status":"Completed","completion_date":"2020-07-01","last_update":"2021-02-25","description":"Psoriasis Vulgaris is a chronic, recurrent, inflammatory and hyperproliferative skin disease. Joint involvement is common along with skin involvement. However, metabolic diseases, such as cardiovascular diseases can be accompanied by many systemic diseases, chronic and repetitive due to the quality of life and psychological status of patients can affect. For this reason, patients carry out various research on their diseases on social media and follow programs on these issues in other media such as television and radio. However, there is no study on how much patients are interested in these publications, how much they trust them, and how they reach and organize information via social media. The aim of the study will be to clarify how and how patients with Psoriasis Vulgaris use social media to obtain information about the diagnosis and treatment of their disease, the interaction of patient groups with each other, and how often social media is used, especially in which group of patients.","other_id":"IstanbulMU5","observational_model":"Ecologic or Community","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":90,"population":"psoriasis vulgaris patients","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Psoriasis vulgaris patients\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  patients that don't want to answer questions\r\n      ","sponsor":"Istanbul Medeniyet University","sponsor_type":"Other","conditions":"Psoriasis Vulgaris","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Social media use of psoriasis vulgaris patients, a questionnaire will be asked the patients and try to learn how they use social media for getting information about their disease.","time_frame":"July 2020"}]}
{"nct_id":"NCT04978155","start_date":"2020-01-01","enrollment":193,"brief_title":"Usefulness of Doppler Ultrasound Carried Out by the Vascular Surgeon After Loco-regional Anesthesia for Preferred Access","official_title":"Usefulness of Doppler Ultrasound Carried Out by the Vascular Surgeon After Loco-regional Anesthesia for Preferred Access","primary_completion_date":"2021-02-01","study_type":"Observational","rec_status":"Completed","completion_date":"2021-07-01","last_update":"2021-07-27","description":"Preoperative vascular mapping with echo-Doppler is acknowledged as indispensable to create an arteriovenous fistula for haemodialysis (AVF). The conditions for performing this examination are not always ideal (venous vasospasm in cool temperatures, variability of the volume status in the dialysis patient). On the other hand, the use of a loco-regional anaesthesia (LRA) results in the vasodilation of the limb thus rendering it possible to use the veins which were initially considered too small. The aim of this study is to assess the functionality of our AVF when ultrasound identification was used by the surgeon after the LRA. These results have been compared with those of the preceding year during which this identification was not implemented.","other_id":"ECHO FAV","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"All the patients who had an AVF creation with preoperative venous identification by the\r\n        surgeon at CHU de TOULOUSE during the year 2020.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Native AVF access\r\n\r\n          -  During the year 2020\r\n\r\n          -  Preoperative mapping during the consultation\r\n\r\n          -  Loco-regional anesthesia\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Redo surgery\r\n      ","sponsor":"University Paul Sabatier of Toulouse","sponsor_type":"Other","conditions":"Arterio-venous Fistula","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Duplex ultrasound performed by the surgeon after locoregional anesthesia","description":"Just after locoregional anesthesia, the surgeon perform a duplex ultrasound to determinate if the target vessel chosen to create the arterio-venous fistulae match with the pre-operative duplex performed during the consultation. So the plan can be changed such as more distal, more proximal creation, changing vein or artery target."}],"outcomes":[{"outcome_type":"primary","measure":"Functionality of the AVF at the time of the postoperative","time_frame":"6 weeks","description":"An AVF is defined as functional if all the criteria of the good development of the haemodialysis access (based on the National Kidney Foundation's criteria) are present : Blood flow>600ml, diameter over 6mm and lower depth of 6mm"},{"outcome_type":"secondary","measure":"The rate of planning change between the surgical project at the time of the consultation and the AVF that is finally placed","time_frame":"During the surgery"},{"outcome_type":"secondary","measure":"Primary, assisted primary and secondary permeability of our accesses","time_frame":"12 months","description":"permeability was based on the criteria of the Society for Vascular Surgery : primary permeability lasts from the creation to the first dilation episode or transposition of anastomosis required to maintain the access. Assisted primary permeability ends at the time of the first occlusion episode. Secondary permeability ends with the abandonment or the definitive withdrawal of the AVF due to failure"}]}
{"nct_id":"NCT04771325","start_date":"2019-12-30","phase":"N/A","enrollment":535,"brief_title":"Assessment of the Effectiveness of Continuous Labour Support by a Trained Companion of Choice on Events of Labor and Maternal Satisfaction in the Bugisu Sub Region, Uganda","official_title":"Assessment of the Effectiveness of Continuous Labour Support by a Trained Companion of Choice on Events of Labor and Maternal Satisfaction in the Bugisu Sub Region, Uganda","primary_completion_date":"2021-06-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-08-30","last_update":"2021-02-25","description":"A randomized control trial employing a cross sectional stepped wedge design. Women with anticipated vaginal delivery, receiving usual care for the control group while women receiving usual care plus support from a trained companion will constitute the experimental group. Events and outcomes will then be assessed during and after birth.","other_id":"2017-54","allocation":"Randomized","intervention_model":"Sequential Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","intervention_model_description":"Educational; training of lay persons on support during labour","sampling_method":"","gender":"Female","minimum_age":16,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Women with a singleton fetus and a supposed cephalic presentation.\r\n\r\n          2. Women with a female friend or relative willing to stay with them through the process\r\n             of labor and birth.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Women with a multiple pregnancy.\r\n\r\n          -  Women with a previous cesarean section\r\n\r\n          -  Women who are mentally incapacitated or deaf and dumb\r\n      ","sponsor":"Makerere University","sponsor_type":"Other","conditions":"Labor Long","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Support from a trained companion","description":"Birth companions trained on how to effectively support women during labor"}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of a Spontaneous Vaginal delivery","time_frame":"labour duration","description":"delivery of the baby naturally without use of oxytocin, vacuum extraction, or a cesarean section"},{"outcome_type":"secondary","measure":"coping and anxiety","time_frame":"labour duration","description":"Women's self-reported anxiety on admission and after birth will be measured using the 10 cm Visual Analogue Scales Coping with labour will be assessed using the Roberts coping with labour algorithm the midwife looks out for cues for coping and not coping"},{"outcome_type":"secondary","measure":"Length of labour","time_frame":"labour duration","description":"From time of admission (4-6cm) to birth"},{"outcome_type":"secondary","measure":"Apgar score","time_frame":"At 1 and 5 minutes","description":"Apgar score of baby at birth"},{"outcome_type":"secondary","measure":"use of oxytocin to augment labor","time_frame":"labor duration","description":"Use of oxytocin to augment labor"},{"outcome_type":"secondary","measure":"Maternal satisfaction questionnaire","time_frame":"Labour duration","description":"Level of satisfaction on support, information, pain control, humaneness and general satisfaction with birthing experience"}]}
{"nct_id":"NCT04230993","start_date":"2019-12-24","phase":"N/A","enrollment":210,"brief_title":"Efficacy of Two Nasal Products for Decongestion and Mucus Fluidification","official_title":"Clinical Evaluation of the Efficacy of Two Nasal Products for Decongestion and Mucus Fluidification","primary_completion_date":"2020-06-20","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-06-20","last_update":"2020-07-14","description":"The main objective is to compare the effect of nasal washing on nasal discharge and nasal congestion during treatment after 3 days of use.","other_id":"2019-A01705-52","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":3,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Person with an upper respiratory condition (cold, rhinitis, nasopharyngitis ...) with\r\n             symptoms of nasal congestion and intense runny nose moderate to severe (Jackson\r\n             derived score  4)\r\n\r\n          -  Ability of the patient (for adults) or their legal representative (for children) to\r\n             follow the guidelines of the medical device\r\n\r\n          -  have given their written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patient with no cold symptoms, including no nasal congestion (chronic dry rhinitis)\r\n\r\n          -  Patient under treatment with cortisone derivative, mucolytic, or medication containing\r\n             pseudoephedrine or related product acting on nasal congestion or having used such a\r\n             product in the 3 days before inclusion\r\n\r\n          -  Patient who used a nasal wash product in the 3 days before inclusion\r\n\r\n          -  Patient allergic to seafood, or to any of the components of the products under study\r\n\r\n          -  Vulnerable patient whose inclusion is not justified by the research objectives: woman\r\n             pregnant, parturient, psychiatric patient, or adult subject to legal protection\r\n\r\n          -  Patient participating or having participated in any other clinical study in the 30\r\n             days before the study.\r\n      ","sponsor":"YSLab","sponsor_type":"Industry","conditions":"Rhinitis","interventions":[{"intervention_type":"Other","name":"Other: Sea water solution","description":"Administration of different sea water solution is performed and the rating of cold symptoms according to the Jackson scale, the fluidity of mucus and the ease of blowing will be evaluated."}],"outcomes":[{"outcome_type":"primary","measure":"Effect of nasal washing with a hypertonic seawater solution Nose hygiene).","time_frame":"3 days","description":"Effect of nasal washing with a hypertonic seawater solution (Ocean Bio Actif-Fluid + or Ocean Bio Actif-Stuffy nose) on runny nose and nasal congestion during treatment after 3 days of use, compared to an isotonic solution (Ocean Bio Actif- Nose hygiene). symptom score (runny nose and nasal congestion) derived from the Jackson scale with a score of 0 to 3 for each (0: absent; 1: mild; 2: moderate; 3: severe) between Day 0 and Day 3."},{"outcome_type":"secondary","measure":"Symptom score","time_frame":"7 days","description":"The effect of nasal wash on the evolution of symptoms over time"},{"outcome_type":"secondary","measure":"Presence or absence of fluid mucus","time_frame":"7 days","description":"The effect of nasal wash on the evolution of the mucus fluidification over time"},{"outcome_type":"secondary","measure":"Global Clinical Impression Scale","time_frame":"between day 3 and day 7","description":"Global Clinical Impression of the investigator on the evolution of symptoms"},{"outcome_type":"secondary","measure":"Global Patient Impression Scale","time_frame":"between day 3 and day 7","description":"Global Impression of the patient on the evolution of symptoms"},{"outcome_type":"secondary","measure":"Use of medical device","time_frame":"7 days","description":"Number of daily sprays"},{"outcome_type":"secondary","measure":"Safety of medical device","time_frame":"7 days","description":"Number of adverse events"},{"outcome_type":"secondary","measure":"Likert scale","time_frame":"7 days","description":"Satisfaction of patient for the medical device"},{"outcome_type":"secondary","measure":"Number of concomitant treatment","time_frame":"7 days","description":"concomitant administration of treatments related to rhinitis"}]}
{"nct_id":"NCT04000763","start_date":"2019-12-20","phase":"N/A","enrollment":20,"brief_title":"Superficial Peroneal Nerve Neuromodulation for Non-Obstructive Urinary Retention","official_title":"Superficial Peroneal Nerve Neuromodulation for Non-Obstructive Urinary Retention","primary_completion_date":"2021-06-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-06-30","last_update":"2021-04-09","description":"Millions of Americans are suffering from underactive bladder (UAB). The impact of severe UAB, i.e. non-obstructive urinary retention (NOUR) on quality of life is significant because current treatment for non-obstructive urinary retention requires intermittent self-catheterization or an indwelling suprapubic catheter. Currently an effective drug for non-obstructive urinary retention does not exist. It is a therapeutic challenge for clinicians to successfully treat non-obstructive urinary retention. Sacral neuromodulation has been approved by the FDA since 1999 to treat non-obstructive urinary retention. It achieves >50% improvement in bladder emptying (reducing the frequency of self-catheterization or increasing voided volume) in just over half of the patients. Sacral neuromodulation requires surgical implantation of a stimulator and a lead with 4 electrodes. The surgery and implant are invasive and expensive, preventing a broad application of this effective therapy to many non-obstructive urinary retention patients. The goal of this study is to develop a novel non-invasive neuromodulation therapy for non-obstructive urinary retention as an alternative. Specifically, the investigators will explore the possibility to translate into humans a recent discovery in cats of an excitatory reflex from the superficial peroneal nerve to the bladder to treat non-obstructive urinary retention. Therefore, in this study the investigators propose to develop a non-invasive, transcutaneous neuromodulation therapy for non-obstructive urinary retention that can be administered at home.","other_id":"STUDY19010062","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","intervention_model_description":"All experiments proposed in this grant application will be performed in female non-obstructive urinary retention patients. We chose not to study male patients in this study given the need to exclude bladder outlet obstruction from benign prostatic hyperplasia (BPH), an evaluation that is invasive and costly.","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":90,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Able to provide informed consent\r\n\r\n          1. 18 years of age and older\r\n\r\n          2. Clinically diagnoses as non-obstructive urinary retention\r\n\r\n          3. Post Void Residual of 300 mL or greater\r\n\r\n          4. Currently using daily self-catheterization to empty the bladder\r\n\r\n          5. Capable of using the toilet independently without difficulty\r\n\r\n          6. Capable and willing to follow all study-related procedures\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Neurologic diagnosis (including diabetes mellitus)\r\n\r\n          2. Surgery within one year of screening for urinary outlet obstruction\r\n\r\n          3. Pregnant or planning to become pregnant during study duration\r\n\r\n          4. OnabotulinumtoxiA use in bladder or pelvic floor muscles with the past year\r\n\r\n          5. Pacemaker or implantable defibrillator\r\n\r\n          6. Current Urinary tract or vaginal infections\r\n\r\n          7. Current Interstim use\r\n\r\n          8. Current Percutaneous tibial nerve stimulation (PTNS) or transcutaneous electrical\r\n             nerve stimulation (TENS) use in pelvis or back or legs\r\n\r\n          9. Investigational drug/ device therapy with the past 4 weeks,\r\n\r\n         10. Participation in any clinical investigation involving or impacting gynecologic or\r\n             urinary function with the past 4 weeks,\r\n\r\n         11. Previous surgery of or damage to the foot or nerves in the foot and leg.\r\n      ","sponsor":"MARIA PERE","sponsor_type":"Other","conditions":"Urinary Retention|Urinary Bladder, Underactive","interventions":[{"intervention_type":"Device","name":"Device: superficial peroneal nerve stimulation","description":"A commercially available FDA-approved transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes will be used to stimulate the foot. The electrodes will be attached to the dorsal surface of the foot and a sock will be placed over the foot to prevent detachment of the electrodes. Based on our animal studies, foot stimulation parameters of 2 Hz frequency and 0.2 ms pulse width will be used at the maximal intensity comfortable for each patient. It is expected that superficial peroneal nerve stimulation in patients can increase bladder sensation so that micturition can be initiated at a small bladder volume, or it can initiate bladder contraction at a small bladder volume and enhance the contraction or prolong the duration of contraction. Any of these excitatory effects, if occurs in human patients, will certainly improve the condition of non-obstructive urinary retention."}],"outcomes":[{"outcome_type":"primary","measure":"Number of voids per subject in 24 hours.","time_frame":"3 weeks","description":"Counted using a patient voiding diary both before and after superficial peroneal nerve stimulation."},{"outcome_type":"primary","measure":"Number of catheterizations per subject in 24 hours.","time_frame":"3 weeks","description":"Counted using a patient voiding diary both before and after superficial peroneal nerve stimulation."},{"outcome_type":"primary","measure":"Volume of urine per void.","time_frame":"3 weeks","description":"Calculated in millimeters both before and after peroneal nerve stimulation."},{"outcome_type":"primary","measure":"Catheterized Post Void Residual volume","time_frame":"3 weeks","description":"Calculated in millimeters both before and after peroneal nerve stimulation."},{"outcome_type":"primary","measure":"Bladder Voiding efficiency","time_frame":"3 weeks","description":"Pre voiding and post voiding ratio that reflects bladder contractility"},{"outcome_type":"primary","measure":"Bladder capacity","time_frame":"3 weeks","description":"Calculated by adding the voided volume to the post residual catheterization volume, in milliliters"},{"outcome_type":"secondary","measure":"Efficacy of Foot Stimulation","time_frame":"2 weeks","description":"Difference in millimeters of bladder emptying capacity from week 2 to baseline"},{"outcome_type":"secondary","measure":"Efficacy of Foot Stimulation","time_frame":"3 weeks","description":"Difference in millimeters of bladder emptying capacity from week 3 to baseline"},{"outcome_type":"secondary","measure":"Post-stimulation effect","time_frame":"1 week","description":"Difference in millimeters of bladder emptying capacity from week 2 to week 3."}]}
{"nct_id":"NCT04878783","start_date":"2019-12-20","enrollment":50,"brief_title":"RADIOMICS AND MOLECULAR EXPRESSION PREDICTIVE MODEL FOR ESOPHAGO-GASTRIC JUNCTION AND GASTRIC CANCER TRG","official_title":"CT SCAN-BASED RADIOMICS AND MOLECULAR EXPRESSION PREDICTIVE MODEL TO ASSESS TUMOR REGRESSION GRADE FOLLOWING PERIOPERATIVE CHEMOTHERAPY IN ESOPHAGO-GASTRIC JUNCTION AND GASTRIC CANCER","primary_completion_date":"2022-06-01","study_type":"Observational [Patient Registry]","rec_status":"Recruiting","completion_date":"2022-12-10","last_update":"2021-05-07","description":"The aim of this study is to develop a CT scan-based radiomics predictive model about tumor regression grade (TRG) in patients with esophago-gastric junction (EGJ) ang gastric cancer undergoing perioperative chemotherapy. The molecular expression of the neoplasms will be evaluated to assess its association with the TRG and the radiomic features.","other_id":"URomLS2022","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients with cT2-T4a, cN0-N3, M0 gastric or EGJ cancer who undergo FLOT perioperative\r\n        chemotherapy followed by radical surgical resection.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with histologically proven adenocarcinoma of the EGJ (Siewert II-III) or\r\n             stomach.\r\n\r\n          -  Preoperative staging: cT2-T4a, cN0-N3, M0.\r\n\r\n          -  Patients >18 years old.\r\n\r\n          -  Patients undergoing perioperative chemotherapy with Docetaxel, oxaliplatin,\r\n             leucovorin, and 5-fluorouracil (FLOT).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Siewert I EGJ tumor\r\n\r\n          -  Patients undergoing preoperative radiotherapy.\r\n\r\n          -  Absence of both pre and post-chemotherapy CT-scan.\r\n\r\n          -  Patients with tumor progression during preoperative chemotherapy.\r\n\r\n          -  Patients undergoing other neoadjuvant chemotherapy regimen different from FLOT\r\n\r\n          -  Exploratory laparoscopy with positive cytology on the peritoneal lavage or evidence of\r\n             peritoneal carcinosis\r\n      ","sponsor":"University of Roma La Sapienza","sponsor_type":"Other","conditions":"Gastric Cancer|Adenocarcinoma of the Stomach","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: CT scan","description":"Patients undergoing CT scan staging for gastric and EJ junction cancer + perioperative chemotherapy (FLOT regimen) , CT scan re-staging and radical gastrectomy or esophagogastrectomy will be enrolled in the study"}],"outcomes":[{"outcome_type":"primary","measure":"Predictive performance of radiomics analysis on the pre-treatment CT scan.","time_frame":"2 months","description":"Comparing the radiomic features of the CT scans at the time of diagnosis (T0) and at the end of the preoperative chemotherapy (T1) in order to predict the TRG with the texture analysis on the first CT scan."},{"outcome_type":"secondary","measure":"Association of the radiomics features with the molecular expression of the tumor.","time_frame":"2 months","description":"Texture analysis on the pre-chemotherapy CT scan founded that entropy and compactness were higher and uniformity lower in responders. Nonetheless the association between radiomics features and molecular expression has not been investigated yet.\r\nTherefore, we hypothesize to add some others radiomics signatures to the analysis and to find an association with the molecular expression."},{"outcome_type":"secondary","measure":"Evaluation of the association between TRG and the molecular expression of the tumor.","time_frame":"2 months","description":"Investigate if the molecular expression of the tumor can influence the TRG"},{"outcome_type":"secondary","measure":"Association between radiomics and molecular expression in regards to long-term outcomes","time_frame":"5 years","description":"Analysis of the 3 and 5y DFS and OS of patients with the radiomics and molecular expression profile"}]}
{"nct_id":"NCT04332367","start_date":"2019-12-19","phase":"Phase 2","enrollment":59,"brief_title":"Carboplatin, Taxane And Ramucirumab for Patients With NSCLC After Pemetrexed or Pembrolizumab Maintenance","official_title":"Phase II, Single-Arm Study Of Carboplatin, Weekly Taxane, And Ramucirumab In Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) After Progressive Disease On Maintenance Pemetrexed And/Or Pembrolizumab","primary_completion_date":"2022-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2024-12-31","last_update":"2021-01-12","description":"The purpose of this study is to determine if the combination of the three anti-cancer drugs carboplatin, paclitaxel, and ramucirumab is helpful in shrinking tumors or delaying tumor growth in participants with non-small cell lung cancer. This study will also assess whether it is safe to combine these drugs.","other_id":"UPCC 05519","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Advanced non-squamous NSCLC (Stage IV or recurrent after initial curative intent\r\n             therapy) in adults age 18 or older\r\n\r\n          -  Prior exposure to 4-6 cycles of Pem/Carbo/Pembro and PD after at least 18 weeks of\r\n             maintenance Pemetrexed, Pembrolizumab or the combination of the two.\r\n\r\n          -  PS 0-1\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Presence of a driver mutation that is susceptible to targeted therapy\r\n\r\n          -  Other active invasive malignancy requiring ongoing therapy\r\n\r\n          -  Grade 2 or higher sensory neuropathy\r\n\r\n          -  Evidence of untreated brain metastases\r\n\r\n          -  History of bleeding diatheses or recent, antecedent hemoptysis (> 1/2 teaspoon in\r\n             prior 2 months)\r\n      ","sponsor":"Abramson Cancer Center of the University of Pennsylvania","sponsor_type":"Other","conditions":"Non-small Cell Lung Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Carboplatin","description":"Carboplatin IV"},{"intervention_type":"Drug","name":"Drug: Paclitaxel","description":"Paclitaxel IV"},{"intervention_type":"Drug","name":"Drug: Ramucirumab","description":"Ramucirumab IV"}],"outcomes":[{"outcome_type":"primary","measure":"To estimate overall response rate","time_frame":"3 years","description":"Overall response rate (ORR) as determined by RECIST criteria. Response will be defined by a complete response (CR) or partial response (PRO), confirmed or unconfirmed."},{"outcome_type":"secondary","measure":"Progression-free survival","time_frame":"From first dose of study drug until progressive disease, death or last assessment contact, whichever comes first, an average of 1-2 years","description":"Progression-free survival (PFS) defined as the duration from the first study dose of study drug until progressive disease, death or last assessment contact whichever comes first."},{"outcome_type":"secondary","measure":"Overall Survival","time_frame":"from the first dose of study drug until death, last observation or contact, an average of 1-2 years","description":"Overall Survival (OS) is defined as the time from the first dose of study drug until death due to any cause or last observation or contact."},{"outcome_type":"secondary","measure":"Safety Evaluations: number of Grade ≥ 3 as determined by CTCAE v 5.0","time_frame":"Initiation through 30 days following the last administration of study treatment.","description":"Toxicity will be estimated by the number of Grade ≥ 3 as determined by CTCAE v 5.0."}]}
{"nct_id":"NCT04138277","start_date":"2019-12-18","phase":"Phase 3","enrollment":110,"brief_title":"A Study to Assess the Long-term Safety and Efficacy of ATB200/AT2221 in Adult Subjects With LOPD","official_title":"A Phase 3 Open-label Extension Study to Assess the Long-term Safety and Efficacy of Intravenous ATB200 Co-administered With Oral AT2221 in Adult Subjects With Late Onset Pompe Disease","primary_completion_date":"2023-12-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2023-12-31","last_update":"2021-03-02","description":"This is a multicenter, international open-label extension study of ATB200/AT2221 in adult subjects with late-onset Pompe disease (LOPD) who completed Study ATB200-03.","other_id":"ATB200-07","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        1. Subject must have completed Study ATB200-03.\r\n\r\n        Exclusion Criteria\r\n\r\n          1. Subject plans to receive gene therapy or participate in another interventional study\r\n             for Pompe disease.\r\n\r\n          2. Subject, if female, is pregnant or breastfeeding.\r\n\r\n          3. Subject, whether male or female, is planning to conceive a child during the study.\r\n      ","sponsor":"Amicus Therapeutics","sponsor_type":"Industry","conditions":"Pompe Disease (Late-onset)","interventions":[{"intervention_type":"Drug","name":"Drug: AT2221","description":"Participants received ATB200 co-administered with AT2221 (Miglustat)"},{"intervention_type":"Biological","name":"Biological: ATB200","description":"Enzyme Replacement Therapy via intravenous infusion"}],"outcomes":[{"outcome_type":"secondary","measure":"6-Minute Walk Test","time_frame":"baseline, up to approximately 4 years","description":"Change in 6MWD from baseline to assess the efficacy of ATB200/AT2221 co-administration"},{"outcome_type":"primary","measure":"Proportion of participants with Treatment Emergent Adverse Events (TEAE)","time_frame":"baseline, up to approximately 4 years"},{"outcome_type":"secondary","measure":"Pulmonary Function - Forced vital capacity (FVC)","time_frame":"baseline, up to approximately 4 years","description":"Change from baseline in FVC (sitting) to assess the efficacy of ATB200/AT2221 co-administration"},{"outcome_type":"secondary","measure":"Change from baseline in muscle strength measured by Quantitative Muscle Strength testing","time_frame":"baseline, up to approximately 4 years"},{"outcome_type":"secondary","measure":"Change from baseline in muscle strength measured by Manual Muscle Strength testing","time_frame":"baseline, up to approximately 4 years"},{"outcome_type":"secondary","measure":"The Rasch-built Pompe-specific activity (R-PAct) questionnaires","time_frame":"baseline, up to approximately 4 years","description":"Change in R-Pact from baseline to assess the efficacy of ATB200/AT2221 co-administration"},{"outcome_type":"secondary","measure":"EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) questionnaires","time_frame":"baseline, up to approximately 4 years","description":"Change from baseline in scores of EQ-5D-5L questionnaire to assess the efficacy of ATB200/AT2221 co-administration."},{"outcome_type":"secondary","measure":"Change from baseline in scores of PROMIS - physical function questionnaire","time_frame":"baseline, up to approximately 4 years"},{"outcome_type":"secondary","measure":"Change from baseline in scores of PROMIS - fatigue questionnaire","time_frame":"baseline, up to approximately 4 years"},{"outcome_type":"secondary","measure":"Change from baseline in scores of PROMIS - dyspnea questionnaire","time_frame":"baseline, up to approximately 4 years"},{"outcome_type":"secondary","measure":"Change from baseline in scores of PROMIS - upper extremity questionnaire","time_frame":"baseline, up to approximately 4 years"},{"outcome_type":"secondary","measure":"Motor Function - Gait, Stairs, Gower, Chair (GSGC) test","time_frame":"baseline, up to approximately 4 years","description":"Change from baseline in GSGC score to assess the efficacy of ATB200/AT2221 co-administration."},{"outcome_type":"secondary","measure":"Physician's Global Impression of Change","time_frame":"baseline, up to approximately 4 years","description":"Change in the Physician's Global Impression of Change (PGIC) evaluation to assess the efficacy of ATB200/AT2221 co-administration."},{"outcome_type":"secondary","measure":"Subject's Global Impression of Change","time_frame":"baseline, up to approximately 4 years","description":"Change from baseline in scores of Subject's Global Impression of Change (SGIC) questionnaire to assess the efficacy of ATB200/AT2221 co-administration."},{"outcome_type":"secondary","measure":"Change from baseline Biomarker -CK","time_frame":"baseline, up to approximately 4 years"},{"outcome_type":"secondary","measure":"Change from baseline Biomarker -uHex4","time_frame":"baseline, up to approximately 4 years"},{"outcome_type":"secondary","measure":"Immunogenicity: Incidence of neutralizing","time_frame":"baseline, up to approximately 4 years"},{"outcome_type":"secondary","measure":"Immunogenicity: anti-drug antibodies","time_frame":"baseline, up to approximately 4 years"}]}
{"nct_id":"NCT04202497","start_date":"2019-12-18","phase":"Phase 1","enrollment":7,"brief_title":"A Study With [18F]MNI-1054 to Determine Lysine -Specific Demethylase 1A (LSD1) Brain Enzyme Occupancy of TAK-418 After Single-Dose Oral Administration in Healthy Participants","official_title":"A Phase 1, Open-label, Positron Emission Tomography Study With [18F]MNI-1054 to Determine Lysine-Specific Demethylase 1A Brain Enzyme Occupancy of TAK-418 After Single-Dose Oral Administration in Healthy Subjects","primary_completion_date":"2020-03-05","study_type":"Interventional","rec_status":"Terminated","completion_date":"2020-03-19","last_update":"2021-07-30","description":"The purpose of this study is to determine brain LSD1 enzyme occupancy and the relationship of occupancy to TAK-418 dose and plasma exposure after single oral dosing of TAK-418 in healthy participants using [18F]MNI-1054 positron emission tomography (PET) imaging.","other_id":"TAK-418-0004","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. The participant must have a body mass index (BMI) greater than or equal to (>=) 18.5\r\n             and less than or equal to (<=) 30.0 kilogram per square meter (kg/m^2) at the\r\n             screening visit.\r\n\r\n          2. The participant must be a current nonsmoker at screening as demonstrated by negative\r\n             cotinine test.\r\n\r\n          3. The participant has adequate circulation to both hands for safe placement of arterial\r\n             lines (as determined by Allen's test).\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Has a known hypersensitivity to any component of the formulation of TAK-418 or related\r\n             compounds, including [18F]MNI-1054.\r\n\r\n          2. The participant has a positive alcohol or drug screen.\r\n\r\n          3. The participant has a history of alcohol consumption exceeding 2 standard drinks per\r\n             day on average (1 glass is approximately equivalent to the following: beer [354\r\n             milliliter (mL)/12 ounce (oz)], wine [118 mL/4 oz], or distilled spirits [29.5 mL/1\r\n             oz] per day).\r\n\r\n          4. The participant consumes excessive amounts, defined as greater than 6 servings (1\r\n             serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola,\r\n             energy drinks, or other caffeinated beverages per day.\r\n\r\n          5. The participant has a substance abuse disorder.\r\n\r\n          6. The participant cannot tolerate venipuncture or has poor venous access that would\r\n             cause difficulty in collecting blood samples.\r\n\r\n          7. The participant has contraindications to undergoing magnetic resonance imaging (MRI)\r\n             examination including but not limited to implants, such as implanted cardiac\r\n             pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular\r\n             foreign body, implanted neural stimulators, central nervous system aneurysm clips, and\r\n             other medical implants that have not been certified for MRI, or history of\r\n             claustrophobia in MRI.\r\n\r\n          8. The participant has clinically significant abnormal findings on brain MRI scan that in\r\n             the opinion of the investigator may interfere with the interpretation of the PET\r\n             imaging.\r\n\r\n          9. The participant has experienced an acute illness within 10 days before the screening\r\n             visit.\r\n\r\n         10. The participant has a risk of suicide according to the investigator's clinical\r\n             judgement per the Columbia-Suicide Severity Rating Scale at screening or has made a\r\n             suicide attempt in the 12 months before screening.\r\n\r\n         11. The participant has luteinizing hormone, follicle stimulating hormone (FSH), or\r\n             estradiol levels that are clinically abnormal.\r\n\r\n         12. The participant has existing skin rashes that can be diagnosed as dermatitis.\r\n      ","sponsor":"Takeda","sponsor_type":"Industry","conditions":"Healthy Volunteers","interventions":[{"intervention_type":"Drug","name":"Drug: TAK-418","description":"TAK-418 orally."},{"intervention_type":"Drug","name":"Drug: [18F]MNI-1054 (radiotracer)","description":"[18F]MNI-1054 injection."}],"outcomes":[{"outcome_type":"primary","measure":"Quantitative Estimates of Binding of [18F]MNI-1054 Based on PET Radiotracer Kinetic Models At Baseline Scan on Day -1","time_frame":"Day -1","description":"Enzyme binding parameter [Ki] was obtained from irreversible 2-tissue compartment model (mL/cm^3/min). Data is reported for the following brain regions: cerebellum, frontal lobe, hippocampus, occipital Lobe, pons, and striatum. Here, mL/cm^3/min signifies 'milliliter per cubic centimeter per minute'."},{"outcome_type":"primary","measure":"Quantitative Estimates of Binding of [18F]MNI-1054 Based on PET Radiotracer Kinetic Models on Day 1","time_frame":"Day 1","description":"Enzyme binding parameter [Ki] was obtained from irreversible 2-tissue compartment model (mL/cm^3/min). Data is reported for the following brain regions: cerebellum, frontal lobe, hippocampus, occipital Lobe, pons, and striatum. Here, mL/cm^3/min signifies 'milliliter per cubic centimeter per minute'."},{"outcome_type":"primary","measure":"Quantitative Estimates of Binding of [18F]MNI-1054 Based on PET Radiotracer Kinetic Models on Day 2","time_frame":"Day 2","description":"Enzyme binding parameter [Ki] was obtained from irreversible 2-tissue compartment model (mL/cm^3/min). Data is reported for the following brain regions: cerebellum, frontal lobe, hippocampus, occipital Lobe, pons, and striatum. Here, mL/cm^3/min signifies 'milliliter per cubic centimeter per minute'."},{"outcome_type":"primary","measure":"Percent Enzyme Occupancy Based on Quantitative Estimates of Binding for TAK-418 on Day 1","time_frame":"Day 1","description":"Lysine-Specific Demethylase 1A (LSD1) enzyme occupancy (%) in region of interest (ROI) after a single dose of TAK-418 was obtained from the baseline and postdose Ki values as follows: occupancy (1st postdose) = 100*(Ki [baseline] - Ki [1st postdose]) / Ki (baseline). Data is reported for following brain regions: cerebellum, frontal lobe, hippocampus, occipital Lobe, pons, and striatum."},{"outcome_type":"primary","measure":"Percent Enzyme Occupancy Based on Quantitative Estimates of Binding for TAK-418 on Day 2","time_frame":"Day 2","description":"LSD1 enzyme occupancy (%) in ROI after a single dose of TAK-418 was obtained from the baseline and postdose Ki values as follows: occupancy (2nd postdose) = 100*(Ki [baseline] - Ki [2nd postdose]) / Ki (baseline). Data is reported for following brain regions: cerebellum, frontal lobe, hippocampus, occipital Lobe, pons, and striatum."},{"outcome_type":"primary","measure":"Cmax: Maximum Observed Plasma Concentration for TAK-418","time_frame":"Day 1: pre-dose and at multiple time points (up to 3 hours) post-dose, immediately before and after the Day 1 PET scan, and within 30 minutes before and 30 minutes after Day 2 or 3 PET scan"},{"outcome_type":"primary","measure":"AUClast: Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration for TAK-418","time_frame":"Day 1: pre-dose and at multiple time points (up to 3 hours) post-dose, immediately before and after the Day 1 PET scan, and within 30 minutes before and 30 minutes after Day 2 or 3 PET scan"},{"outcome_type":"primary","measure":"AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-418","time_frame":"Day 1: pre-dose and at multiple time points (up to 3 hours) post-dose, immediately before and after the Day 1 PET scan, and within 30 minutes before and 30 minutes after Day 2 or 3 PET scan"},{"outcome_type":"secondary","measure":"ED50 PET Enzyme Occupancy","time_frame":"Days 1 to 2","description":"The relationship between PET enzyme occupancy and TAK-418 dose level was investigated using an Emax model containing the regression parameters maximal target occupancy (Emax) and dose that gives 50 percent (%) of Emax (ED50). ED50 values are reported for following brain regions: cerebellum, frontal lobe, hippocampus, occipital Lobe, pons, and striatum. The data tabulated are the estimated value and confidence intervals of the ED50 value derived from an Emax model fit across all data points from all arms. ED50 is the dose at which 50% enzyme occupancy is expected."},{"outcome_type":"secondary","measure":"Number of Participants Reporting One or More Adverse Events (AEs) and Serious Adverse Events (SAEs)","time_frame":"From first dose of [18F]MNI-1054 radiotracer injection up to Day 14"},{"outcome_type":"secondary","measure":"Number of Participants With Clinically Significant Abnormal Laboratory Values","time_frame":"From first dose of [18F]MNI-1054 radiotracer injection up to Day 14"},{"outcome_type":"secondary","measure":"Number of Participants With Clinically Significant Abnormal Vital Signs","time_frame":"From first dose of [18F]MNI-1054 radiotracer injection up to Day 14"}]}
{"nct_id":"NCT04266392","start_date":"2019-12-16","phase":"Early Phase 1","enrollment":20,"brief_title":"Molecular Imaging of Prostate Cancer Using Radiofluorinated PSMA Ligand","official_title":"Molecular Imaging of Prostate Cancer Using Radiofluorinated PSMA Ligand","primary_completion_date":"2020-12-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2020-12-01","last_update":"2020-02-12","description":"Eligible patients have prostate cancer that was treated with surgery or radiation therapy for localized disease and there is evidence of biochemical recurrence and/or metastases on conventional imaging.The objective of this study is to assess the performance in detection of prostate cancer of a new positron emission tomography (PET) radiotracer for prostate cancer ([18F]-DCFPyl) combined with magnetic resonance imaging (MRI). Results of tracer uptake and MRI image features as whole body PET/MRI and dedicated pelvic/prostate PET/MRI, alone and together, will be correlated and compared to detection of lesions on conventional imaging modalities. Additionally, if the patient undergoes a biopsy as standard of care, image features will correlate directly with histopathological findings.Validation of this radiotracer can potentially lead to its use as a standard of care for future imaging and improve diagnosis and treatment guidance.This drug is not approved by the Food and Drug Administration (FDA) and is therefore considered experimental.There will be 20 subjects enrolled in this study; all of these patients will be enrolled at Stony Brook University Medical Center.","other_id":"889520","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  subject has prostate cancer treated with surgery, radiation therapy and/or\r\n             chemotherapy for localized disease\r\n\r\n          -  subject has biochemical recurrence defined in postsurgical patients as a PSA value = >\r\n             0.2 ng/mL followed by a subsequent confirmatory PSA value = >0.2 ng/mL according to\r\n             the American Urological Association (AUA) guidelines, or three consecutive rises above\r\n             the nadir in patients following radiation therapy according to the American Society\r\n             for Radiation Therapy and Oncology (ASTRO).\r\n\r\n          -  in most cases, it will be required that the patient has had a prior CIM scan (such as\r\n             a BS, MRI, CT or PET with F-18 Fluciclovine) performed before enrollment in this\r\n             study; the only exception would be if the PSA level of the patient is remarkably high\r\n             indicating apparent recurrence.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  less than 18 years of age (prostate cancer is not prevalent in the pediatric\r\n             population);\r\n\r\n          -  any contraindications to MRI imaging such as electrical implants, cardiac pacemakers\r\n             or perfusion pumps;\r\n\r\n          -  ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial\r\n             hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or\r\n             ferromagnetic objects such as jewelry or metal clips in clothing;\r\n\r\n          -  is unable to lie comfortably on a bed inside the scanner for 60 minutes as assessed by\r\n             physical examination and medical history (e.g. back pain, arthritis);\r\n\r\n          -  if they have had treatment with investigational drug within 30 days prior to trial\r\n             enrollment;\r\n\r\n          -  if they had administration of another radioisotope within five physical half-lives of\r\n             trial enrollment;\r\n\r\n          -  if they had radiation or chemotherapy within 4 weeks prior to trial enrollment;\r\n\r\n        Eligibility will be determined by a screening interview. All subjects recruited for the\r\n        study will be able to withdraw from the study at any time.\r\n      ","sponsor":"Stony Brook University","sponsor_type":"Other","conditions":"Prostate Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: [18F]-DCFPyl Ligand","description":"To assess the performance of [18F]-DCFPyl PET with whole-body MRI and multiparametric pelvic/prostate MRI for PCa detection in men with recurrence as determined by biochemical PSA level or evidence on CIM. Results of tracer uptake and MRI image features on whole body PET/MRI and dedicated pelvic/prostate PET/MRI, alone and together, will be correlated and compared to detection of lesions on CIM that usually includes bone scan (BS) and CT scan of the abdomen and pelvis, or PET imaging with F-18 Fluciclovine.In addition, in patients who undergo biopsy when performed as standard of care, we will correlate image features directly with histopathological findings on lesion biopsy to directly demonstrate that 'radiotracer and/or MRI positive' lesions contain tumor cells."}],"outcomes":[{"outcome_type":"primary","measure":"Comparison of PET PSMA and Conventional Imaging","time_frame":"Within 1 year from the PET Imaging study","description":"Compare [18F]DCFPyL PET imaging combined with whole body magnetic resonance imaging (MRI) and multiparametric pelvic/prostate MRI to conventional imaging modalities (CIM)--such as 99mTc-methylene diphosphonate bone scan (BS) and contrast-enhanced CT (CECT) of the abdomen and pelvis, or a newly approved PET imaging agent F-18 Fluciclovine, for the localization and determination of extent of recurrent/metastatic disease in patients with biochemical recurrence of prostate cancer or evidence of recurrence on CIM."},{"outcome_type":"primary","measure":"Sensitivity and Specificity of PET/MRI PSMA in biochemical recurrence","time_frame":"Within 1 year from the PET Imaging study","description":"Determine the sensitivity and specificity of [18F]-DCFPyL PET/MRI for extent of recurrent/metastatic disease in patients with biochemical recurrence."}]}
{"nct_id":"NCT04957875","start_date":"2019-12-16","enrollment":3300,"brief_title":"Timing of Endoscopy for Acute Variceal Bleeding in Patients With Cirrhosis","official_title":"Timing of Endoscopy for Acute Variceal Bleeding in Patients With Cirrhosis (CHESS1905): a Nationwide Cohort Study","primary_completion_date":"2019-12-16","study_type":"Observational","rec_status":"Completed","completion_date":"2020-06-02","last_update":"2021-07-12","description":"Cirrhotic patients with AVB across 34 university medical centers in 30 cities in China from February 2013 to May 2020 who underwent endoscopy within 24 hours were included in this study. Patients were divided into an urgent endoscopy group (endoscopy <6h after admission) and an early endoscopy group (endoscopy 6-24h after admission). Outcomes included the incidence of 5-day rebleeding, in-hospital mortality, need for intensive care unit (ICU) and the length of hospital stay after the endoscopy management. Multivariable analysis was performed to identify risk factors for rebleeding. A propensity score matching (PSM) analysis was performed to achieve a balance at baseline between the urgent and early groups.","other_id":"CHESS1905","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":75,"population":"Complete demographic and clinical data of patients with cirrhosis associated with AVB who\r\n        underwent emergency endoscopy within 24 hours between February 2013 and May 2020 across 34\r\n        university hospitals from 30 cities in China was retrospectively reviewed. Two independent\r\n        investigators (Liu C and Huang Y) reviewed the medical records, including demographic,\r\n        laboratory, clinical and endoscopic data.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  established diagnosis of cirrhosis (based on liver biopsy or the combination of\r\n             clinical, biochemical, and imaging findings)\r\n\r\n          -  witnessed or reported evidence of gastrointestinal haemorrhage (hematemesis,\r\n             melenemesis, or hematochezia)\r\n\r\n          -  esophageal or gastric varices confirmed endoscopically as the source of bleeding\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  severe dysfunction of a major extrahepatic organ (e.g., heart failure, pulmonary\r\n             disease, and terminal malignancy except hepatocellular carcinoma)\r\n\r\n          -  history of endoscopic therapy for varices (ligation or sclerotherapy) within three\r\n             months\r\n\r\n          -  incomplete or missing data\r\n      ","sponsor":"Hepatopancreatobiliary Surgery Institute of Gansu Province","sponsor_type":"Other","conditions":"Cirrhosis, Liver|Portal Hypertension|Varice Bleed","interventions":[{"intervention_type":"Device","name":"Device: emergency endoscopic therapy","description":"When cirrhotic patients presented with AVB to the emergency department, emergency physicians consulted gastroenterologists on duty to assess the patient for suitability for endoscopy, usually after initial stabilization. Performance of endoscopy and its timing was at the discretion of the gastroenterologist on call. Therapeutic endoscopy for AVB was performed within 24 hours after consultation by an experienced attending endoscopist, using standard forward-viewing upper gastrointestinal video endoscopes at individual centers. Written informed consent for endoscopy was obtained before each procedure. The standard of care at all hospitals was to administer a vasoactive agent and antibiotics upon the patient's presentation. Packed red blood cells were transfused at the discretion of the attending gastroenterologist."}],"outcomes":[{"outcome_type":"primary","measure":"the incidence of 5-day rebleeding after emergency endoscopy","time_frame":"6 months"},{"outcome_type":"secondary","measure":"the in-hospital mortality","time_frame":"6 months"},{"outcome_type":"secondary","measure":"need for ICU","time_frame":"6 months"},{"outcome_type":"secondary","measure":"the length of hospital stay","time_frame":"6 months"}]}
{"nct_id":"NCT04160988","start_date":"2019-12-16","enrollment":703,"brief_title":"A Single-center, Retrospective Study to Evaluate the Clinical Performance of Artificial Intelligence Medical Assisted Diagnostic Software (VeriSee DR) for Screening of Diabetic Retinopathy in Patients With Diabetes Mellitus","official_title":"A Single-center, Retrospective Study to Evaluate the Clinical Performance of Artificial Intelligence Medical Assisted Diagnostic Software (VeriSee DR) for Screening of Diabetic Retinopathy in Patients With Diabetes Mellitus","primary_completion_date":"2020-01-31","study_type":"Observational","rec_status":"Completed","completion_date":"2020-05-11","last_update":"2021-01-29","description":"This study is to evaluate the clinical performance of VeriSee DR for DR screening from color fundus photography images in patients with diabetes mellitus. The sensitivity and specificity of VeriSee DR's automated image analysis for screening the diabetes retinopathy will be determined.","other_id":"QCR19002","observational_model":"Case-Only","time_perspective":"Retrospective","sampling_method":"Probability Sample","gender":"All","minimum_age":20,"population":"Persons with diabetes, twenty years of age or older, who have been referred to an\r\n        ophthalmologists for a dilated eye examination to detect diabetic retinopathy.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subjects enrolled in this study should meet all the following criteria.\r\n\r\n               1. Subject with age  20 years old\r\n\r\n               2. Subject with documented diagnosis of diabetes mellitus\r\n\r\n               3. Subject with image taken by color fundus photography that meet the following\r\n                  requirement:\r\n\r\n                    -  The resolution of image is 10241024 pixels or higher;\r\n\r\n                    -  The angle view of image is 45 or 50 degree.\r\n\r\n               4. Subject's image includes macula and optic nerve as judged by the ophthalmologist.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subjects will be excluded if they meet any of the following criteria.\r\n\r\n               1. The color fundus photography image previously used by VeriSee DR during the\r\n                  development process and pre-clinical test\r\n\r\n               2. The macula, optic nerve, or other part in the image of color fundus photography\r\n                  is unclear to determine the disease condition as judged by the ophthalmologist.\r\n      ","sponsor":"Acer Being Health Inc.","sponsor_type":"Industry","conditions":"Diabetic Retinopathy","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Sensitivity","time_frame":"2 months","description":"To evaluate the clinical performance of VeriSee DR by determining the sensitivity.\r\nSensitivity = 100% x TP/(TP+FN)"},{"outcome_type":"primary","measure":"Specificity","time_frame":"2 months","description":"To evaluate the clinical performance of VeriSee DR by determining the specificity.\r\nSpecificity = 100% x TN/(TN+FP)"},{"outcome_type":"secondary","measure":"Positive Predictive Values (PPV)","time_frame":"2 months","description":"To evaluate the clinical performance of VeriSee DR by determining the positive predictive values (PPV).\r\nPositive predictive value (PPV) =100% x TP/(TP+FP)"},{"outcome_type":"secondary","measure":"Negative Predictive Values (NPV)","time_frame":"2 months","description":"To evaluate the clinical performance of VeriSee DR by determining the negative predictive values (NPV).\r\nNegative predictive value (NPV) = 100% x TN/(FN+TN)"},{"outcome_type":"secondary","measure":"Percentage of Participant Images With Insufficient Quality as Judged by VeriSee DR","time_frame":"2 months","description":"To determine the percentage of subjects' images with insufficient quality as judged by VeriSee DR.\r\nThe percentage of subjects who have the images with insufficient quality as determined by VeriSee DR will be presented."}]}
{"nct_id":"NCT04179071","start_date":"2019-12-13","phase":"Phase 1","enrollment":16,"brief_title":"A Study in Healthy Male Subjects to Understand How Savolitinib Behaves Inside the Body (Pharmacokinetics) When Administered Alone and in Combination With Famotidine","official_title":"An Open-Label, Randomised, Two Part, Two Treatment Crossover Study in Healthy Subjects to Assess the Pharmacokinetics of Savolitinib When Administered Alone and in Combination With Famotidine","primary_completion_date":"2020-03-11","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-03-11","last_update":"2020-07-07","description":"This will be an open-label, randomised, 2 part (Part A and Part B), 2 treatment (savolitinib alone or in combination with famotidine), crossover study in healthy, non Japanese, male subjects, performed at a single study centre.","other_id":"D5084C00005","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Provision of signed and dated written informed consent prior to any study specific\r\n             procedures.\r\n\r\n          -  Healthy, non-Japanese male subjects with suitable veins for cannulation or repeated\r\n             venipuncture: male subjects aged 18 to 65 years (inclusive).\r\n\r\n          -  Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive; and weigh at least 50\r\n             kg and no more than 100 kg inclusive.\r\n\r\n          -  Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total bilirubin\r\n             (TBL) less than or equal to the upper limit of normal for the institution.\r\n\r\n          -  Have a calculated creatinine clearance greater than 80 mL/min using the\r\n             Cockcroft-Gault formula at screening.\r\n\r\n          -  Provision of signed, written and dated informed consent for optional genetic/biomarker\r\n             research. If a subject declines to participate in the genetic component of the study,\r\n             there will be no penalty or loss of benefit to the subject. The subject will not be\r\n             excluded from other aspects of the study described in this protocol.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subject that has at least 1 parent or grandparent (maternal or paternal) of Japanese\r\n             ethnicity.\r\n\r\n          -  Subjects who screen positive for Helicobacter pylori bacteria.\r\n\r\n          -  History of any clinically significant disease or disorder which, in the opinion of the\r\n             Principal Investigator (PI), may either put the volunteer at risk because of\r\n             participation in the study, or influence the results or the volunteer's ability to\r\n             participate in the study.\r\n\r\n          -  History or presence of gastrointestinal (GI), hepatic or renal disease, or any other\r\n             condition known to interfere with absorption, distribution, metabolism, or excretion\r\n             of drugs.\r\n\r\n          -  Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks\r\n             of the first administration of either study drug (savolitinib or famotidine).\r\n\r\n          -  Planned in-patient surgery, dental procedure, or hospitalisation during the study.\r\n\r\n          -  Any clinically important abnormalities in clinical chemistry, haematology, or\r\n             urinalysis results, as judged by the PI.\r\n\r\n          -  Any positive result on screening for serum hepatitis B surface antigen, hepatitis C\r\n             antibody, and human immunodeficiency virus (HIV) antibody.\r\n\r\n          -  Abnormal vital signs, after 5 minutes supine rest, defined as any of the following:\r\n\r\n               1. Systolic BP <90 mmHg or 140 mmHg\r\n\r\n               2. Diastolic BP <50 mmHg or 90 mmHg\r\n\r\n               3. Heart rate <45 or >85 beats per minute.\r\n\r\n          -  Any clinically important abnormalities in rhythm, conduction or morphology of the 12\r\n             lead resting electrocardiogram (ECG) that may interfere with the interpretation of QTc\r\n             interval changes. These include healthy subjects with any of the following:\r\n\r\n               1. Abnormal ST-T-wave morphology, particularly in the protocol-defined primary lead\r\n                  (V2) or left ventricular hypertrophy.\r\n\r\n               2. PR interval shortening <120 ms (PR >110 ms but <120 ms is acceptable if there is\r\n                  no evidence of ventricular pre-excitation).\r\n\r\n               3. PR interval prolongation (>200 ms). Intermittent second (Type 1 second degree\r\n                  block [Wenckebach Phenomenon] while asleep is not exclusive]) or third degree\r\n                  atrioventricular (AV) block, or AV dissociation.\r\n\r\n               4. Persistent or intermittent complete bundle branch block, incomplete bundle branch\r\n                  block, or intraventricular conduction delay with QRS >110 ms. Subjects with QRS\r\n                  >110 ms but <115 ms are acceptable if there is no evidence of eg, ventricular\r\n                  hypertrophy or pre-excitation.\r\n\r\n               5. Mean resting prolonged QTcF >450 ms or shortened QTcF <340 ms obtained from 3\r\n                  ECGs.\r\n\r\n          -  A history of additional risk factors for torsades de pointes (TdP) (eg, heart failure,\r\n             chronic hypokalaemia not correctable with supplements, congenital or familial long QT\r\n             syndrome, or family history of unexplained sudden death under 40 years of age in\r\n             first-degree relatives).\r\n\r\n          -  Use of any medications known to prolong the QT/QTc interval and cause TdP.\r\n\r\n          -  Use of any prescribed or non prescribed medication including antacids, analgesics\r\n             (other than ibuprofen up to 72 hours before dosing day), herbal remedies, megadose\r\n             vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during\r\n             the 2 weeks prior to the first administration of either study drug or longer if the\r\n             medication has a long half life.\r\n\r\n          -  Known or suspected history of drug abuse, as judged by the PI.\r\n\r\n          -  Current smokers or those who have smoked or used nicotine products within the previous\r\n             30 days.\r\n\r\n          -  History of alcohol abuse or excessive intake of alcohol as judged by the PI.\r\n\r\n          -  Excessive intake of caffeine-containing drinks or food (eg, coffee, tea, chocolate) as\r\n             judged by the PI.\r\n\r\n          -  Use of drugs with enzyme inducing properties such as St John's Wort, within 3 weeks\r\n             prior to the first administration of either study drug.\r\n\r\n          -  Any intake of grapefruit, grapefruit juice, Seville oranges, Seville orange marmalade,\r\n             or other products containing grapefruit or Seville oranges within 7 days of the first\r\n             admission on Day -1.\r\n\r\n          -  Positive screen for drugs of abuse or cotinine (nicotine) or alcohol at screening and\r\n             before each admission to the Study Centre.\r\n\r\n          -  History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as\r\n             judged by the PI, or history of hypersensitivity to drugs with a similar chemical\r\n             structure or class to savolitinib or famotidine.\r\n\r\n          -  Plasma donation within 1 month of screening or any blood donation or loss of >500 mL\r\n             during the 3 months prior to screening.\r\n\r\n          -  Has received another new chemical entity (defined as a compound which has not been\r\n             approved for marketing) within 3 months of the first administration of either study\r\n             drug in this study. The period of exclusion begins 3 months after the final dose or\r\n             one month after the last visit whichever is the longest. Note: subjects consented and\r\n             screened, but not randomised in this study or a previous Phase I study, are not\r\n             excluded.\r\n\r\n          -  Subjects who have previously received savolitinib.\r\n\r\n          -  Involvement of any AstraZeneca, Parexel, or study site employee or their close\r\n             relatives.\r\n\r\n          -  Judgment by the PI that the subject should not participate in the study if they have\r\n             any ongoing or recent (ie, during the screening period) minor medical complaints that\r\n             may interfere with the interpretation of study data or are considered unlikely to\r\n             comply with study procedures, restrictions, and requirements.\r\n\r\n          -  Subjects who are vegans or vegetarians, or have medical dietary restrictions.\r\n\r\n          -  Subjects who cannot communicate reliably with the PI.\r\n\r\n          -  Vulnerable subjects, eg, kept in detention, protected adults under guardianship,\r\n             trusteeship, or committed to an institution by governmental or juridical order.\r\n\r\n          -  In addition, any of the following is regarded as a criterion for exclusion from the\r\n             genetic research:\r\n\r\n          -  In addition, the following are considered criteria for exclusion from the optional\r\n             genetic component of the study:\r\n\r\n          -  Previous bone marrow transplant.\r\n\r\n          -  Non-leukocyte depleted whole blood transfusion within 120 days of the date of the\r\n             genetic sample collection or previous bone marrow transplant.\r\n      ","sponsor":"AstraZeneca","sponsor_type":"Industry","conditions":"Solid Tumours","interventions":[{"intervention_type":"Drug","name":"Drug: Famotidine","description":"Subjects will receive famotidine tablet 40mg orally after an overnight (minimum 8hours) of fasting."},{"intervention_type":"Drug","name":"Drug: Savolitinib","description":"Subject will receive savolitinib tablet 600mg orally after a high-fat, high-calorie meal."}],"outcomes":[{"outcome_type":"primary","measure":"Maximum observed plasma concentration (Cmax) ratio","time_frame":"At pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36, and 48 hours post-dose on Day 1-3 and Day 16-18","description":"Cmax ratio of test treatment (savolitinib+famotidine) relative to reference treatment (savolitinib alone) to assess effect of the gastric acid modifier, famotidine, on the PK of savolitinib."},{"outcome_type":"primary","measure":"Area under plasma concentration-time curve from zero to infinity (AUC) ratio","time_frame":"At pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36, and 48 hours post-dose on Day 1-3 and Day 16-18","description":"AUC ratio of test treatment (savolitinib+famotidine) relative to reference treatment (savolitinib alone) to assess effect of the gastric acid modifier, famotidine, on the PK of savolitinib."},{"outcome_type":"secondary","measure":"Number of subjects with having adverse events and/or abnormal findings in vital signs and/or laboratory evaluation and/or physical examination","time_frame":"From 28-day screening period to follow-up period i.e. 60 days","description":"To investigate the safety and tolerability of savolitinib in combination with famotidine."},{"outcome_type":"secondary","measure":"AUC geometric means ratio of test treatment (savolitinib+famotidine) relative to reference treatment (savolitinib alone)","time_frame":"At pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36, and 48 hours post-dose on Day 1-3 and Day 16-18","description":"To assess the effect of famotidine on the PK of savolitinib metabolites M2 and M3 and to describe the PK parameters and the PK concentration-time profiles for savolitinib, M2, and M3 when savolitinib is administered alone and in combination with famotidine."},{"outcome_type":"secondary","measure":"Area under the plasma concentration curve from time zero to time of last quantifiable concentration AUC(0-t)","time_frame":"At pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36, and 48 hours post-dose on Day 1-3 and Day 16-18","description":"AUC(0-t) geometric means ratio of test treatment (savolitinib+famotidine) relative to reference treatment (savolitinib alone) to assess the effect of famotidine on the PK of savolitinib metabolites M2 and M3 and to describe the PK parameters and the PK concentration-time profiles for savolitinib, M2, and M3 when savolitinib is administered alone and in combination with famotidine."},{"outcome_type":"secondary","measure":"Cmax geometric means ratio of test treatment (savolitinib+famotidine) relative to reference treatment (savolitinib alone)","time_frame":"At pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36, and 48 hours post-dose on Day 1-3 and Day 16-18","description":"To assess the effect of famotidine on the PK of savolitinib metabolites M2 and M3 and to describe the PK parameters and the PK concentration-time profiles for savolitinib, M2, and M3 when savolitinib is administered alone and in combination with famotidine."},{"outcome_type":"secondary","measure":"Cmax metabolite-to-parent ratios (MRCmax)","time_frame":"At pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36, and 48 hours post-dose on Day 1-3 and Day 16-18","description":"MRCmax ratio of test treatment (savolitinib+famotidine) relative to reference treatment (savolitinib alone) to assess the effect of famotidine on the PK of savolitinib metabolites M2 and M3 and to describe the PK parameters and the PK concentration-time profiles for savolitinib, M2, and M3 when savolitinib is administered alone and in combination with famotidine."},{"outcome_type":"secondary","measure":"AUC metabolite-to-parent ratios (MRAUC)","time_frame":"At pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36, and 48 hours post-dose on Day 1-3 and Day 16-18","description":"MRAUC ratio of test treatment (savolitinib+famotidine) relative to reference treatment (savolitinib alone) to assess the effect of famotidine on the PK of savolitinib metabolites M2 and M3 and to describe the PK parameters and the PK concentration-time profiles for savolitinib, M2, and M3 when savolitinib is administered alone and in combination with famotidine."},{"outcome_type":"secondary","measure":"AUC(0-t) metabolite-to-parent ratios [MRAUC(0-t)]","time_frame":"At pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36, and 48 hours post-dose on Day 1-3 and Day 16-18","description":"MRAUC(0-t) ratio of test treatment (savolitinib+famotidine) relative to reference treatment (savolitinib alone) to assess the effect of famotidine on the PK of savolitinib metabolites M2 and M3 and to describe the PK parameters and the PK concentration-time profiles for savolitinib, M2, and M3 when savolitinib is administered alone and in combination with famotidine."},{"outcome_type":"secondary","measure":"Time to reach maximum observed plasma concentration (tmax)","time_frame":"At pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36, and 48 hours post-dose on Day 1-3 and Day 16-18","description":"tmax ratio of test treatment (savolitinib+famotidine) relative to reference treatment (savolitinib alone) to assess the effect of famotidine on the PK of savolitinib metabolites M2 and M3 and to describe the PK parameters and the PK concentration-time profiles for savolitinib, M2, and M3 when savolitinib is administered alone and in combination with famotidine."},{"outcome_type":"secondary","measure":"Half-life associated with terminal slope (λz) of a semi logarithmic concentration-time curve (t½,λz)","time_frame":"At pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36, and 48 hours post-dose on Day 1-3 and Day 16-18","description":"t½,λz ratio of test treatment (savolitinib+famotidine) relative to reference treatment (savolitinib alone) to assess the effect of famotidine on the PK of savolitinib metabolites M2 and M3 and to describe the PK parameters and the PK concentration-time profiles for savolitinib, M2, and M3 when savolitinib is administered alone and in combination with famotidine."},{"outcome_type":"secondary","measure":"Terminal elimination rate constant (λz)","time_frame":"At pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36, and 48 hours post-dose on Day 1-3 and Day 16-18","description":"λz ratio of test treatment (savolitinib+famotidine) relative to reference treatment (savolitinib alone) to assess the effect of famotidine on the PK of savolitinib metabolites M2 and M3 and to describe the PK parameters and the PK concentration-time profiles for savolitinib, M2, and M3 when savolitinib is administered alone and in combination with famotidine."},{"outcome_type":"secondary","measure":"Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)","time_frame":"At pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36, and 48 hours post-dose on Day 1-3 and Day 16-18","description":"Vz/F ratio of test treatment (savolitinib+famotidine) relative to reference treatment (savolitinib alone) to assess the effect of famotidine on the PK of savolitinib metabolites M2 and M3 and to describe the PK parameters and the PK concentration-time profiles for savolitinib, M2, and M3 when savolitinib is administered alone and in combination with famotidine."},{"outcome_type":"secondary","measure":"Apparent total body clearance of drug from plasma after extravascular administration (CL/F)","time_frame":"At pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36, and 48 hours post-dose on Day 1-3 and Day 16-18","description":"CL/F ratio of test treatment (savolitinib+famotidine) relative to reference treatment (savolitinib alone) to assess the effect of famotidine on the PK of savolitinib metabolites M2 and M3 and to describe the PK parameters and the PK concentration-time profiles for savolitinib, M2, and M3 when savolitinib is administered alone and in combination with famotidine."}]}
{"nct_id":"NCT04066114","start_date":"2019-12-11","phase":"Phase 1/Phase 2","enrollment":10,"brief_title":"Treg Modulation With CD28 and IL-6 Receptor Antagonists","official_title":"Regulatory T Cell Modulation in Kidney Transplantation With Biologic Blockade of Dual Effector Pathways, CD28 and IL-6 (CTOT-24)","primary_completion_date":"2022-06-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-12-31","last_update":"2021-02-26","description":"The purpose of this study is to evaluate the safety of using lulizumab pegol with tocilizumab, belatacept, and everolimus in kidney transplant recipients.","other_id":"DAIT CTOT-24","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Individuals who meet all the following criteria are eligible for enrollment as study\r\n        participants:\r\n\r\n          1. Able to understand and provide informed consent\r\n\r\n          2. Agreement to use highly effective (<1% failure rate) methods of contraception: Women\r\n             of Childbearing Potential (WOCBP)-\r\n\r\n               -  Progestogen only hormonal contraception associated with inhibition of ovulation,\r\n\r\n               -  Hormonal methods of contraception including oral contraceptive pills containing a\r\n                  combination of estrogen + progesterone, vagina ring, injectables, implants and\r\n                  intrauterine devices (IUDs),\r\n\r\n               -  Non-hormonal IUDs,\r\n\r\n               -  Bilateral tubal occlusion,\r\n\r\n               -  Vasectomized partner,\r\n\r\n               -  Intrauterine hormone-releasing system (IUS), or\r\n\r\n               -  Complete abstinence.\r\n\r\n             Note: Female participants of childbearing potential must consult with their physician\r\n             and determine the most suitable method(s) from this list to be used for 12 months\r\n             while on study drug regimen.\r\n\r\n             Male Participants-\r\n\r\n             --Must use a latex or other synthetic condom during any sexual activity with WOCBP\r\n             until one month after the last dose of lulizumab (e.g., up to 3.5 months in duration).\r\n\r\n          3. Recipient of primary, nonhuman leukocyte antigen identical living donor kidney\r\n             transplant\r\n\r\n          4. No donor specific antibodies prior to transplant that are considered to be of clinical\r\n             significance by the site investigator\r\n\r\n          5. Epstein-Barr virus (EBV) positive serology\r\n\r\n          6. Cytomegalovirus (CMV) positive serology, unless donor-recipient pair are both CMV\r\n             negative\r\n\r\n          7. Negative testing for latent Tuberculosis (TB) infection within 3 months prior to\r\n             transplant\r\n\r\n               -  Testing should be conducted using either a purified protein derivative (PPD) or\r\n                  an interferon-gamma release assay blood test for TB (i.e. QuantiFERON-TB Gold\r\n                  in-Tube test or T-SPOT TB test)\r\n\r\n               -  Subjects with a positive test for latent TB infection must complete appropriate\r\n                  therapy for Latent tuberculosis infection (LTBI). ---A subject is considered\r\n                  eligible only if they have a negative test for LTBI within 3 months prior to\r\n                  transplant or, they have appropriately completed LTBI therapy prior to\r\n                  transplant.\r\n\r\n             Note: Latent TB infection treatment regimens should be among those endorsed by the CDC\r\n             (Division of TB Elimination, 2016).\r\n\r\n          8. In the absence of contraindication, vaccinations must be up to date for hepatitis B,\r\n             influenza, pneumococcal, varicella and herpes zoster, and measles, mumps, and rubella\r\n             (MMR)\r\n\r\n          9. Hepatitis C Virus (HCV) antibody positive subjects with negative HCV by PCR testing\r\n             are eligible if they:\r\n\r\n               -  have spontaneously cleared infection, or\r\n\r\n               -  are in sustained virologic remission for at least 12 weeks after treatment for\r\n                  HCV.\r\n\r\n         10. Negative SARS-CoV-2 PCR test result performed within 2 weeks of transplant (SARS-CoV-2\r\n             is the virus that causes COVID-19)\r\n\r\n        Exclusion Criteria:\r\n\r\n        Individuals who meet any of these criteria are not eligible for enrollment as study\r\n        participants-\r\n\r\n          1. Prisoners or subjects who are compulsorily detained\r\n\r\n          2. Inability or unwillingness of a participant to give written informed consent or comply\r\n             with study protocol\r\n\r\n          3. Candidate for a multiple solid organ or tissue transplants\r\n\r\n          4. Prior history of organ or cellular transplantation\r\n\r\n          5. Known to have idiopathic focal segmental glomerulosclerosis (FSGS) as the underlying\r\n             cause of kidney failure (ESRD)\r\n\r\n          6. Requirement for uninterrupted anticoagulation therapy, including Plavix.\r\n\r\n          7. Known hypersensitivity to mechanistic target of rapamycin (mTOR) inhibitors or\r\n             contraindication to everolimus (including history of wound healing complications)\r\n\r\n          8. History of severe allergic and/or anaphylactic reactions to humanized or murine\r\n             monoclonal antibodies\r\n\r\n          9. Hypersensitivity to rabbit proteins or rabbit anti-thymocyte Globulin (ATG)\r\n\r\n         10. Known hypersensitivity to ACTEMRA (tocilizumab) or lulizumab pegol (BMS-931699)\r\n\r\n         11. The human immunodeficiency virus (HIV) infected subjects, including those who are well\r\n             controlled on antiretrovirals\r\n\r\n         12. Positive hepatitis B surface antigen (HBSAg), or hepatitis B core antibody (HBcAB)\r\n             serology\r\n\r\n         13. Hepatitis C virus antibody positive (HCV Ab+) subjects who have failed to demonstrate\r\n             sustained viral remission for more than 12 weeks after anti-viral treatment\r\n\r\n         14. Subjects with a previous history of active Tuberculosis (TB)\r\n\r\n         15. Known active current viral, fungal, mycobacterial or other infections (including, but\r\n             not limited to tuberculosis and atypical mycobacterial disease, Hepatitis B and C, and\r\n             herpes zoster)\r\n\r\n         16. Donor or recipient residing in areas where the annual incidence  21 cases per\r\n             100,000) for coccidioidomycosis according to current CDC map:\r\n             (https://www.cdc.gov/fungal/diseases/coccidioidomycosis/causes.html)\r\n\r\n               -  Donors or recipients residing in low risk zones (annual <21 cases per 100,000)\r\n                  will not require additional screening\r\n\r\n         17. History of malignancy except treated basal cell cancer of the skin\r\n\r\n         18. History of hemolytic-uremic syndrome/ thrombotic thrombocytopenia purpura\r\n\r\n         19. History of demyelinating disorders (e.g., multiple sclerosis, chronic inflammation\r\n             demyelinating polyneuropathy)\r\n\r\n         20. History of gastrointestinal perforations, active inflammatory bowel disease or\r\n             diverticulitis\r\n\r\n         21. Any previous treatment with alkylating agents such as chlorambucil, or with total\r\n             lymphoid irradiation\r\n\r\n         22. Receipt of a live vaccine within 30 days prior to transplantation.\r\n\r\n         23. Past or current medical problems or findings from physical examination or laboratory\r\n             testing that are not listed above, which, in the opinion of the investigator, may:\r\n\r\n               -  pose additional risks from participation in the study,\r\n\r\n               -  may interfere with the participant's ability to comply with study requirements,\r\n                  or\r\n\r\n               -  that may impact the quality or interpretation of the data obtained from the study\r\n\r\n         24. Severe hyperlipidemia (defined by total cholesterol >350 mg/dL, LDL >190 mg/dL, or\r\n             triglycerides >500 mg/dL)\r\n\r\n         25. Transaminase levels elevated more than 1.5 times the upper limit of normal (ULN)\r\n             within 7 days prior to enrollment\r\n\r\n         26. The absolute neutrophil count (ANC) < 2,000 per mm^3 within 7 days prior to enrollment\r\n\r\n         27. Platelet count less than 100,000 per mm^3 within 7 days prior to enrollment\r\n\r\n         28. More than 50% CD8+/ CD28- T-cells in peripheral blood\r\n\r\n         29. A calculated panel reactive antibody (cPRA) 20%, as determined by each participating\r\n             site's laboratory\r\n\r\n         30. Positive pregnancy test in women of child bearing potential, currently breastfeeding,\r\n             or planning to become pregnant during the timeframe of the study or follow-up period\r\n\r\n         31. Participation in any other studies with investigational drugs or regimens in the\r\n             preceding year\r\n\r\n         32. A history of a positive SARS-CoV-2 PCR test result (SARS-CoV-2 is the virus that\r\n             causes COVID-19)\r\n      ","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","sponsor_type":"NIH","conditions":"Living-Donor Kidney Transplant|Kidney Transplant Recipients","interventions":[{"intervention_type":"Biological","name":"Biological: lulizumab pegol","description":"25 mg subcutaneously (SC) on Day 1 post transplantation then 12.5 mg SC weekly through day 77 (Week 11)"},{"intervention_type":"Biological","name":"Biological: antithymocyte globulin (rabbit)","description":"1.5 mg/kg intravenously (IV) on Day 0 (day of transplantation) and the day following (Day 1)"},{"intervention_type":"Drug","name":"Drug: methylprednisolone","description":"500 mg (IV) on Day 0 (day of transplantation), 250 mg (IV) on Day 1 and 125 mg (IV) on Day 2"},{"intervention_type":"Biological","name":"Biological: tocilizumab","description":"8 mg/kg (IV) on Day 2 post transplantation followed by 162 mg (SC) every 2 weeks through day 168 (Week 24)"},{"intervention_type":"Drug","name":"Drug: Prednisone","description":"Beginning on Day 3 post transplantation, taken orally: 60 mg daily\r\nDays 4 through 10: 30 mg daily\r\nDays 11 through 17: 20 mg daily\r\nDays 18 through 24: 10 mg daily\r\nAfter Day 24: continued taper of dose to final maintenance dose of 5 mg, per protocol"},{"intervention_type":"Drug","name":"Drug: everolimus","description":"Initial dose of 0.75 mg taken orally twice daily on Day 14 days after transplantation. Dose will be titrated to target trough levels 3-8 ng/mL."},{"intervention_type":"Biological","name":"Biological: belatacept","description":"5 mg/kg (IV) every 4 weeks starting on Day 84 (Week 12) and continuing through Day 364 (Week 52)"},{"intervention_type":"Drug","name":"Drug: mycophenolate mofetil","description":"An option for participants who do not tolerate everolimus: to be switched to either\r\nmycophenolate mofetil 1000 mg administered orally twice daily or\r\nmycophenolic acid"},{"intervention_type":"Drug","name":"Drug: mycophenolic acid","description":"An option for participants who do not tolerate everolimus: to be switched to either\r\nmycophenolic acid 720 mg taken orally twice daily or\r\nmycophenolate mofetil"}],"outcomes":[{"outcome_type":"primary","measure":"Proportion of participants who remain free of biopsy-proven acute T-cell mediated or antibody-mediated rejection as defined by Banff criteria","time_frame":"6 months post transplantation","description":"Definitions:\r\nAcute T cell Mediated Rejection: Biopsy proven rejection defined by histologic evidence of a Banff grade of ≥1A and clinical treatment for acute rejection.\r\nAcute Antibody Mediated Rejection: Diffusely positive immunostaining staining for C4d, presence of circulating anti-donor antibodies, and morphologic evidence of acute tissue injury.\r\nReference: Banff 2007 Classification Renal Allograft Pathology definition of terms."},{"outcome_type":"secondary","measure":"Proportion of participants who remain free of biopsy-proven acute T-cell mediated or antibody-mediated rejection as defined by Banff criteria","time_frame":"12 months post transplantation","description":"Definitions:\r\nAcute T cell Mediated Rejection: Biopsy proven rejection defined by histologic evidence of a Banff grade of ≥1A and clinical treatment for acute rejection.\r\nAcute Antibody Mediated Rejection: Diffusely positive immunostaining staining for C4d, presence of circulating anti-donor antibodies, and morphologic evidence of acute tissue injury.\r\nReference: Banff 2007 Classification Renal Allograft Pathology definition of terms."},{"outcome_type":"other","measure":"EXPLORATORY: Frequency of circulating T Regulatory Cells (Tregs)","time_frame":"Day 0 (Pre-transplant) and -3, -6 and -12 months post transplantation","description":"Mechanistic assay. Evaluation of the frequency of circulating Tregs over time.Exploratory goal: To advance understanding in mechanisms of tolerance."},{"outcome_type":"other","measure":"EXPLORATORY:T Regulatory Cells (Treg) suppressive activity","time_frame":"Day 0 (Pre-transplant) and -3, -6 and -12 months post transplantation","description":"Mechanistic assay.Donor-specific suppression activity of recipient Tregs will be measured over time by using irradiated donor peripheral blood mononuclear cells (PBMCs) as stimulators. Exploratory goal: To advance understanding in mechanisms of tolerance."},{"outcome_type":"other","measure":"EXPLORATORY:Alloreactive T cell frequency","time_frame":"Day 0 (Pre-transplant) and -3, -6 and -12 months post transplantation","description":"Mechanistic assay that measures the frequency of circulating donor-reactive CD4 conventional T cells, CD8 T cells and Tregs analyzed over time. Exploratory goal: To advance understanding in mechanisms of tolerance."},{"outcome_type":"other","measure":"EXPLORATORY:Expression of T cell checkpoint inhibition related genes","time_frame":"Day 0 (Pre-transplant) and -3, -6 and -12 months post transplantation","description":"Methodology: Analysis of gene expression in peripheral blood mononuclear cells (PBMCs) stimulated with donor antigen presenting cells to explore genes implicated in T cell checkpoint inhibition (CTLA-4, SFASL, NFATC1, NFATC2, LAG3 and HAVCR2, as examples). Exploratory goal: To advance understanding in mechanisms of tolerance."}]}
{"nct_id":"NCT04045470","start_date":"2019-12-11","phase":"N/A","enrollment":20,"brief_title":"A Pilot of a Microdevice For In Situ Candidate Drug Screening in Cutaneous Lesions of T-Cell Lymphoma","official_title":"A Pilot of a Microdevice For In Situ Candidate Drug Screening in Cutaneous Lesions of T-Cell Lymphoma","primary_completion_date":"2023-01-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-01-01","last_update":"2021-06-23","description":"This research is being done to study the safety of implanting and retrieving a microdevice that releases up to 19 drugs directly within a cancerous lesion as a possible tool to evaluate the effectiveness of several approved cancer drugs against cutaneous T cell lymphoma and peripheral T cell lymphoma","other_id":"18-639","allocation":"Non-Randomized","intervention_model":"Sequential Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","intervention_model_description":"Expansion cohort may enroll only after initial cohort has completed enrollment","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Participants must have clinical diagnosis of cutaneous T-cell lymphoma or peripheral\r\n             T-cell lymphoma with cutaneous involvement supported by histological evaluation of\r\n             skin lesions.\r\n\r\n          -  Participants must have measurable cutaneous disease, based on the modified Severity\r\n             Weighted Assessment Tool (mSWAT; definition provided in appendix E). Skin lesions\r\n             situated in a previously irradiated area are considered measurable if progression has\r\n             been demonstrated in such lesions.\r\n\r\n          -  Two lesions are amenable to placement of multiple devices in terms of lesion size and\r\n             location, as assessed by dermatologist (minimum diameter of 1.5 cm).\r\n\r\n          -  Patient must have the following minimum washout period from previous treatments and\r\n             cannot be on any systemic therapy at the time of implantation.\r\n\r\n               -  2 week from topical therapies of lesional skin selected for implantation\r\n\r\n               -  2 weeks from retinoids, interferons, vorinostat, romidepsin, therapeutic doses of\r\n                  oral corticosteroids (physiologic replacement doses of oral corticosteoids are\r\n                  allowed)\r\n\r\n               -  4 weeks from phototherapy\r\n\r\n               -  5 half-lives for systemic cytotoxic anticancer agents, monoclonal antibodies, and\r\n                  investigational therapy\r\n\r\n               -  12 weeks from local radiation therapy of lesional skin selected for implantation\r\n\r\n               -  15 weeks from systemic immunotherapy targeting PD-1/PD-L1\r\n\r\n          -  Age minimum of age 18.\r\n\r\n          -  ECOG performance status 2 (Karnofsky 60%, see Appendix A).\r\n\r\n          -  Participants will undergo laboratory testing within 28 days prior to the procedure.\r\n             Participants must have marrow function as defined below:\r\n\r\n               -  absolute neutrophil count 500/mcL\r\n\r\n               -  platelets 50,000/mcL\r\n\r\n          -  Participants must be evaluated by a dermatologist or medical oncologist who will\r\n             determine the clinically appropriate treatment strategy based on clinical history and\r\n             extent of disease. Systemic therapy will be mandatory for cohort 2/expansion cohort,\r\n             not for cohort 1. Systemic therapy may be initiated anytime within 4 weeks of MD\r\n             removal.\r\n\r\n          -  Patients must be deemed medically stable to undergo percutaneous procedures by their\r\n             treating cutaneous oncologist.\r\n\r\n          -  Ability to understand and the willingness to sign a written informed consent document.\r\n\r\n          -  Patients must be willing to undergo research-related genetic and transcriptomic\r\n             sequencing (somatic and germline) and data management, including the deposition of\r\n             de-identified genetic sequencing data in NIH central data repositories.\r\n\r\n          -  Patient is considered to have capacity to properly follow instructions at home for the\r\n             care of device(s) that will each have an attached thin guidewire protruding through\r\n             the skin and fixed in place (see Appendix B).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Positive serum pregnancy test at screening visit.\r\n\r\n          -  Uncorrectable bleeding or coagulation disorder known to cause increased risk with\r\n             surgical or biopsy procedures\r\n\r\n          -  History of allergic reactions attributed to compounds of similar chemical or biologic\r\n             composition to agents used in this study.\r\n\r\n          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active\r\n             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac\r\n             arrhythmia, or psychiatric illness/social situations that would limit compliance with\r\n             study requirements.\r\n\r\n          -  Patients who will receive standard of care systemic therapy are not allowed to start\r\n             any new skin directed therapy (e.g. topical steroids, radiation, phototherapy)\r\n             concurrent with first systemic therapy initiated after device implantation and\r\n             retrieval. Should a patient clinically progress on first systemic therapy and require\r\n             a change in treatment, skin directed therapies may be introduced.\r\n\r\n          -  Patients unable to undergo treatment wash-out period due to rapidly progressive\r\n             disease requiring immediate systemic therapy\r\n      ","sponsor":"Dana-Farber Cancer Institute","sponsor_type":"Other","conditions":"Cutaneous T Cell Lymphoma|Peripheral T Cell Lymphoma","interventions":[{"intervention_type":"Device","name":"Device: Microdevices","description":"The microdevice was developed as a tool with the ultimate goal to help screen several existing and investigational drugs directly within a patient's tumor to identify what drugs are the most effective for treating a patient's cancer."},{"intervention_type":"Other","name":"Other: Standard of care therapy","description":"Participant to receive standard of care therapy as previously determined by participant's treating oncologist and/or dermatologist, which may include a skin-directed or systemic therapy"},{"intervention_type":"Other","name":"Other: Standard of care systemic therapy","description":"Participant to receive standard of care therapy as previously determined by participant's treating oncologist and/or dermatologist, which must include a systemic therapy."}],"outcomes":[{"outcome_type":"primary","measure":"To Quantify The Number Of Microdevice-Related Failures Or Adverse Events As Assessed By CTCAE v4.0 After Microdevice Placement and Removal","time_frame":"2 years","description":"\"Failure\" will be considered any of the following:\r\nAny grade 3 or 4 adverse events associated with device placement or retrieval\r\nAny device resulting in \"major\" adverse events as listed below:\r\ndevice unable to be found or unable to be retrieved\r\ndevice invading into vessel or device embolism\r\ninfection or severe tissue damage or abnormal wound healing associated with device or procedure (as deemed by a neutral consultant e.g. dermatologist, ID specialist or surgeon)\r\nsevere allergic/hypersensitivity reaction\r\nsevere bleeding\r\nAny device resulting in *two or more* \"minor\" adverse events as listed below:\r\ndevice migration more than 10 mm\r\ndevice fracture not causing a major adverse event\r\nmild allergic/hypersensitivity reaction\r\nmanageable pain associated with biopsy procedure\r\nminor bleeding For purposes of this endpoint, safety will be evaluated on a per-patient level, where an event is defined as any \"failure\" observed among all implanted devices."},{"outcome_type":"primary","measure":"To Retrieve The Device With Sufficient Tissue Of Sufficient Quality","time_frame":"2 years","description":"For the feasibility endpoint, a \"successful\" procedure will be defined as the ability to retrieve the device (by either skin punch biopsy tool or surgical excision) without damaging tumor tissue surrounding the microdevice to allow for immunohistochemistry analysis.\r\nFor purposes of this endpoint, feasibility will be assessed on a per-device basis rather than a per-patient basis, with each device considered relatively independent in terms of placement, retrieval, and analysis."},{"outcome_type":"secondary","measure":"Local Intralesional Response To Clinically Relevant Cancer Agents In Cutaneous T Cell Lymphomas","time_frame":"2 years"},{"outcome_type":"secondary","measure":"Intralesional Heterogeneity In Drug Response Using Quantitative Histopathologic Assessment Of Tumor Tissue","time_frame":"2 years","description":"Comparison of tumor responses to like drug delivered from separate microdevices."},{"outcome_type":"secondary","measure":"Assessment Of Microdevice-Predicted Tumor Response To Drug","time_frame":"3 years","description":"Correlation of tumor response to drug released by microdevice compared with clinical response to systemic administration of like drug"},{"outcome_type":"secondary","measure":"Quantitative Assessment Of Drug Effect On The Tumor Microenvironment And Signal Pathways By Immunofluorescence","time_frame":"5 years","description":"Descriptive statistics will be used to summarize the quantitative measurements in cell number of different immunophenotypes and quantify signal transduction cascades. Descriptive statistics will be employed to summarize the variance in different measures of drug-induced microenvironment changes across participants."},{"outcome_type":"secondary","measure":"To Identify Genomic And Transcriptomic Biomarkers of Drug Response by Whole Exome and RNA Sequencing and Subsequent Correlations To Microdevice Predicted Tumor Response","time_frame":"5 years","description":"Genetic alterations will be cataloged in terms of single nucleotide variants, insertions/deletions, and copy number changes and will be reported in a descriptive manner. Preliminary correlations between a specific genetic feature and specific clinical features will be tested using Fisher's exact test for categorical variables or the Wilcoxon Rank-Sum test for continuous variables. Analyses of correlations between genetic and clinical features in different specimen types and patient groups are exploratory, and will rely on descriptive statistics without formal hypothesis testing. For each genetic feature of interest (e.g. mutation, gene expression profile) we will divide patient samples into groups based on the presence or absence of the feature. We will then assess whether the presence of the feature is associated with clinical outcomes using odds ratios, or correlation between genetic feature and overall survival, using Kaplan Meier estimates, with 95% confidence intervals to each."}]}
{"nct_id":"NCT03974503","start_date":"2019-12-02","phase":"N/A","enrollment":96,"brief_title":"Understanding Trauma Nightmares Using In-Home Measurement","official_title":"Characterization of Sleep With Trauma Nightmares Using Ambulatory Sleep Measurement","primary_completion_date":"2024-01-02","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2024-07-01","last_update":"2021-03-10","description":"Trauma-related nightmares in Veterans are associated with poor clinical outcomes, greater substance use, and increased risk of suicide. In spite of an urgent need to reduce the burden of trauma-related nightmares, the underlying physiological changes associated with them are poorly understood, and there are no clear evidence-based recommendations for their treatment. Limitations of current assessment procedures represent a barrier to improved care. In-laboratory sleep studies rarely capture nightmares, limiting the knowledge about them and their response to treatment. This study addresses these limitations by using extended, in-home sleep monitoring to capture sleep data associated with nightmare reports in Veterans, and assessing how these features are altered throughout a cognitive-behavioral nightmare treatment. Results from this study will increase understanding of trauma-related nightmares, and advance strategies for personalizing symptom management for Veterans.","other_id":"MHBB-018-18F","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","intervention_model_description":"Participants will be randomly assigned to one of two cognitive-behavioral treatments for sleep and nightmares.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Be a Veteran enrolled to receive VA medical care at the Philadelphia VA\r\n\r\n          -  Have stable housing for the duration of the study period\r\n\r\n          -  Have experienced any traumatic event meeting Criterion A for PTSD at least three\r\n             months before the baseline assessment\r\n\r\n          -  Meet criteria for a current PTSD diagnosis\r\n\r\n          -  Self-report experiencing trauma-related nightmares at least once per week for the past\r\n             month, that are mostly-remembered and that cause awakening\r\n\r\n          -  Self-report global sleep disturbance indicated by a score of 5 or greater on the\r\n             Pittsburgh Sleep Quality Index (PSQI)\r\n\r\n          -  Be stable on any psychoactive medications for a minimum of two weeks before the\r\n             baseline assessment\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Inability to provide fully-informed written consent to participate and/or a bed\r\n             partner does not agree to mattress recording during the in-home portion of the study\r\n\r\n          -  Medical conditions that limit ability to apply the treatment\r\n\r\n               -  e.g., needing a health aide or caregiver to record sleep diaries, unable to get\r\n                  out of bed without assistance\r\n\r\n          -  Current pregnancy and/or birth of a child within the previous 6 months\r\n\r\n          -  Apnea hypopnea index (AHI) > 15, indicative of moderate to severe sleep apnea, unless\r\n             adherent to positive airway therapy following the baseline phase of the study\r\n\r\n          -  Current alcohol or illicit substance use disorders or early remission (at least 3\r\n             months abstinent)\r\n\r\n          -  Active suicidal or homicidal ideation\r\n\r\n          -  A history of any bipolar disorder spectrum disorder or psychotic disorder\r\n\r\n          -  Hospitalization for a mental health disorder in the past 2 months\r\n\r\n          -  Enrolled in current PTSD-focused treatment (e.g., Cognitive Processing Therapy or\r\n             Prolonged Exposure), current nightmare treatment or a history of treatment failure\r\n             with a cognitive-behavioral nightmare intervention\r\n\r\n          -  Veterans may also be excluded from participation if they have been identified by the\r\n             local VA disruptive behavior committee to have displayed disruptive, threatening\r\n             and/or violent behavior\r\n      ","sponsor":"VA Office of Research and Development","sponsor_type":"U.S. Fed","conditions":"Nightmares|Stress Disorders, Post-Traumatic|Actigraphy|Respiratory Sinus Arrhythmia|Veterans","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Exposure, Relaxation, and Rescripting Therapy","description":"ERRT is a weekly 5-session treatment aimed at reducing chronic trauma nightmares and sleep disturbances in trauma-exposed adults."},{"intervention_type":"Behavioral","name":"Behavioral: Sleep and Nightmare Management","description":"This is a manualized protocol developed to be of similar length but exclude the active components of standard ERRT."}],"outcomes":[{"outcome_type":"other","measure":"Change in suicidal ideation","time_frame":"Baseline, 1-week post-treatment, 3-month follow-up","description":"Change in suicidal ideation will be assessed using the Depressive Symptom Index: Suicidality Subscale (DSI-SS). The four items of the DSI-SS are scored on a 0-3 scale, with total possible sum scores ranging from 0-12; higher scores indicate greater severity of suicidal ideation."},{"outcome_type":"primary","measure":"Change in Actigraphy-derived sleep efficiency (SE)","time_frame":"Nightly up to 7 weeks (Baseline through 1-week post treatment assessment)","description":"Mattress actigraphy will be continuously recorded during the study period. Sleep efficiency is defined as the ratio of the aggregate duration of quiescent sleep periods divided by the duration of the total in bed period. Lower sleep efficiency indicates worse sleep."},{"outcome_type":"primary","measure":"Change in Actigraphy-derived respiratory sinus arrhythmia (RSA)","time_frame":"Nightly (Baseline until 1-week post treatment assessment; 7 weeks)","description":"Mattress actigraphy will be continuously recorded during the study period. RSA is the high frequency powers of heart period variability (0.15-0.4 Hz). Lower RSA indicates more cardiac vagal withdrawal."},{"outcome_type":"primary","measure":"Change in Nightmare Frequency","time_frame":"Baseline past week; Nightly during baseline; 1-week post-treatment; 3-month follow-up treatment period","description":"This fill-in-the-blank variable assesses the number of nightmares experienced in the past week (range = 0 - X nightmares) at each assessment (baseline, one week following treatment, and three months following treatment). Nightly reports will be collected from daily sleep diaries and pushes to event markers during the night."},{"outcome_type":"secondary","measure":"Change in PTSD Symptom Severity","time_frame":"Baseline, 1-week post-treatment, 3-month follow-up","description":"Change in PTSD Symptoms will be assessed using the Clinician-Administered PTSD Scale DSM 5 (CAPS-5) and the self-report PTSD Symptom Checklist. The items on the CAPS-5 are on a 5-point scale (0 - 4), (possible range: 0-80). A symptom is considered present if the severity is rated 2 or higher. Total scores are comprised of four factors (reexperiencing, avoidance, cognitive/emotional and hyperarousal)"},{"outcome_type":"secondary","measure":"Change in Nightmare Severity","time_frame":"Baseline; Nightly during baseline; 1-week post-treatment; 3-month follow-up treatment period","description":"The variable from the Trauma-Related Nightmare Survey assesses the severity of the nightmares experienced in the past week (range = 0 - 4) at each assessment (baseline, one week following treatment, and three months following treatment). Nightly reports of nightmare severity will be collected from daily sleep diaries. Higher scores indicate greater nightmare-related severity."},{"outcome_type":"other","measure":"Home-based overnight polysomnography","time_frame":"Baseline","description":"Nox A1 portable polysomnography system (Nox Medical, Reykjavik, Iceland) used to record sleep stage measures and patterns of arousals, to calibrate sleep efficiency derived from the mattress system, and to detect sleep apnea."},{"outcome_type":"other","measure":"Change in Global Sleep Quality","time_frame":"Baseline, 1-week post-treatment, 3-month follow-up","description":"Change in sleep Quality will be assessed using the Pittsburgh Sleep Quality Index, a 19-item self-report measure assessing qualities and problems associated with sleep in the past month. A global sleep quality score is obtained by summing seven component scores. Higher scores reflect poorer sleep quality. The global score ranges from 0 to 21, with a cut-off score of 5 as distinguishing \"good\" sleepers from \"poor\" sleepers.\r\nThe addendum is used in conjunction with the PSQI for use with trauma-exposed participants and assesses the presence of seven trauma-related sleep disturbances."},{"outcome_type":"other","measure":"Change in self-report depression symptoms","time_frame":"Baseline, 1-week post-treatment, 3-month follow-up","description":"The patient health questionnaire (PHQ-9), is a 9-item self-report instrument used to assess depression severity. Items are scored 0 to 3, with the total score being the sum of the 9 items. Higher scores indicate greater depression severity, with a score of 10 or greater considered major depression, and scores of 20 or more is severe major depression."},{"outcome_type":"other","measure":"Change in Nightmare Effects","time_frame":"Baseline, 1-week post-treatment, 3-month follow-up","description":"Change in the impact of nightmares will be assessed using the change in Nightmare Effects Survey, an 11 item Likert-type questionnaire designed to assess the impact of nightmares on 11 areas of life including work, social, and leisure activities. Total scores range from 0 to 44, with higher scores indicating greater level of nightmare-related impairment."},{"outcome_type":"other","measure":"Change in Fear of Sleep","time_frame":"Baseline, 1-week post-treatment, 3-month follow-up","description":"Change in fear of sleep will be assessed using the Fear of Sleep Inventory, a 23-item self-report measure that assesses trauma-related thoughts and activities associated with sleep and the occurrence of traumas associated with the bedroom or sleep. Total scores range from 0 to 92, with higher scores indicating greater fear of sleep."}]}
{"nct_id":"NCT04191668","start_date":"2019-12-02","phase":"N/A","enrollment":106,"brief_title":"A Validation Study of the NightOwl PAT-based Home Sleep Apnea Test","official_title":"A Validation Study of the NightOwl PAT-based Home Sleep Apnea Test","primary_completion_date":"2020-02-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-02-01","last_update":"2021-03-30","description":"The objective of this study is to evaluate the performance of a miniaturized sleep apnea test, called NightOwl. The system consists of a sensor placed on the fingertip and a cloud-based analytics software. The sensor acquires accelerometer and photoplethysmographic data. The software derives actigraphy from the former, and blood oxygen saturation and peripheral arterial tone (PAT), among other features, from the latter. In order to assess NightOwl's performance, the investigators will compare the respiratory event index (REI), defined as the number of respiratory events per hour of sleep, derived by the NightOwl system, to the apnea-hypopnea index (AHI) obtained from manual analysis of the polysomnography (PSG), which is the gold standard for sleep apnea diagnosis. The investigators will also compare the total sleep time (TST) derived by both systems. This study will be performed in a sleep lab environment.","other_id":"NightOwl-01","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","intervention_model_description":"Single Group will undergo both gold standard polysomnography (PSG) and NightOwl Sleep Apnea Test","sampling_method":"","gender":"All","minimum_age":13,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subjects with an indication for an in-lab polysomnography\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Intellectually disabled people\r\n\r\n          -  People younger than 13 years of age.\r\n      ","sponsor":"Ectosense NV","sponsor_type":"Industry","conditions":"Sleep Apnea","interventions":[{"intervention_type":"Device","name":"Device: NightOwl","description":"The NightOwl is a finger-mounted home sleep apnea testing device"}],"outcomes":[{"outcome_type":"primary","measure":"Pearson Correlation Between the AHI","time_frame":"Through study completion, an average of 1 month.","description":"The evaluation of the Pearson correlation between the apnea-hypopnea index (AHI) estimate obtained from the NightOwl and the AHI determined from the polysomnography (PSG); The AHI is defined as the number of apnea or hypopnea divided by the (estimated) total sleep time expressed in hours."},{"outcome_type":"primary","measure":"Pearson Correlation Between the TST","time_frame":"Through study completion, an average of 1 month.","description":"The evaluation of the Pearson correlation between the total sleep time (TST) estimate obtained from the NightOwl and the TST determined from the PSG;"},{"outcome_type":"primary","measure":"The Evaluation of the Level of Agreement (Classification Accuracy) Between Patient Categorization","time_frame":"Through study completion, an average of 1 month.","description":"The evaluation of the level agreement (classification accuracy) between patient categorization (into sleep apnea severity categories) obtained by the NightOwl and those obtained by the PSG. This measure is calculated by dividing the number of participants on which both NightOwl and the PSG agree on the sleep apnea severity category by the total number of participants."}]}
{"nct_id":"NCT04094025","start_date":"2019-12-02","phase":"Phase 1","enrollment":229,"brief_title":"Irritation and Sensitization Study of d-Amphetamine Transdermal System","official_title":"A Randomized, Evaluator-blinded Study to Evaluate Skin Irritation and Sensitization of d-Amphetamine Transdermal System in Healthy Adults","primary_completion_date":"2020-05-16","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-05-16","last_update":"2020-08-24","description":"The study will assess skin irritation as well as sensitization for d-ATS patch in healthy subjects.","other_id":"N25-018","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Subject provides written informed consent prior to entering the study or undergoing\r\n             any study procedures;\r\n\r\n          2. Healthy male and female (non-pregnant, non-lactating) 18 - 65 years of age inclusive;\r\n\r\n          3. Subject is considered by the Principal Investigator/Sponsor to be healthy on the basis\r\n             of medical history, physical examination, vital signs, electrocardiogram (ECG) and\r\n             clinical laboratory test results. Deviations or excursions considered to be\r\n             non-clinically significant as per the Principal Investigator are acceptable;\r\n\r\n          4. Subject has a normal screening ECG; non-specific ST-T wave changes or other changes\r\n             deemed by the Principal Investigator as not clinically significant are acceptable;\r\n\r\n          5. Female subject is (i) a woman physiologically incapable of becoming pregnant\r\n             [confirmed to be post-menopausal (having amenorrhea for >12 months), has had a\r\n             hysterectomy with or without bilateral oophorectomy at least 6 months prior to the\r\n             Screening Visit] or (ii) a woman of childbearing potential (WOCBP) must have a\r\n             negative pregnancy test at the Screening Visit and must agree to either abstain from\r\n             sexual intercourse or use two forms of reliable barrier method of contraception (e.g.,\r\n             condom with spermicide, diaphragm, IUD, contraceptive sponge) for at least 14 days\r\n             before and throughout the duration of study (from Screening Visit through the\r\n             Follow-up Visit) or have used a hormonal method of contraception for at least 30 days\r\n             before the study and will continue to use the same type of hormonal contraceptive\r\n             during the study. Acceptable forms of birth control include (i) surgical sterilization\r\n             (such as a tubal ligation), which occurred more than 3 months prior to the Screening\r\n             Visit (ii) approved hormonal contraceptives (such as birth control pills, implants or\r\n             injections), (iii) an intrauterine device, (iv) barrier method (condom or occlusive\r\n             cap [diaphragm or cervical/vault caps] used with spermicidal\r\n             foam/gel/film/cream/suppository), (v) Vasectomy in male partner, which occurred more\r\n             than 3 months prior to the Screening Visit; bilateral oophorectomy may be enrolled. If\r\n             the female subject agrees to use an occlusive cap/vault caps with spermicidal\r\n             foam/gel/film/cream/suppository and her male partner agrees to use a condom with\r\n             spermicidal foam/gel/film/cream/suppository, this would constitute as two methods of\r\n             birth control;\r\n\r\n          6. Subject has a body mass index between 18 kg/m2 and 35 kg/m2, inclusive;\r\n\r\n          7. Subject has liver function tests such as alanine aminotransferase (ALT), aspartate\r\n             aminotransferase (AST), alkaline phosphatase and bilirubin 1.5x upper limit of normal\r\n             (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and\r\n             direct bilirubin <35%);\r\n\r\n          8. Subject is capable of understanding and complying with the protocol and has signed the\r\n             Informed Consent Form.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Subject is pregnant or lactating, or females planning a pregnancy during the course of\r\n             the trial;\r\n\r\n          2. Subject with a history or presence of clinically significant disease (glaucoma,\r\n             cardiovascular, hepatic, renal, gastrointestinal, neurologic, psychiatric,\r\n             dermatologic, pulmonary, hematological, musculoskeletal, genitourinary,\r\n             thromboembolic, advanced arteriosclerosis, hyperthyroidism, moderate to severe\r\n             hypertension, asthma, urticaria, angioedema, edema, bronchospasm or immunologic\r\n             disease or any other disorder). Conditions deemed not-clinically significant according\r\n             to the Principal Investigator's discretion are acceptable;\r\n\r\n          3. Subject with a sitting blood pressure (BP) <90/50 or >139/89 mmHg and a sitting heart\r\n             rate (HR) <45 or >90 beats/min;\r\n\r\n          4. Subject has a clinically significant ECG finding or QTcF interval >450 msec for males\r\n             and >470 msec for females;\r\n\r\n          5. Subject has evidence of orthostatic hypotension (decrease of >20 mmHg systolic or >10\r\n             mmHg diastolic or both at supine for 5 minutes and again after assuming an upright\r\n             position for 2 minutes) accompanied by symptoms (faintness, lightheadedness,\r\n             dizziness, confusion);\r\n\r\n          6. Subject has a history of narcotic abuse, drug abuse, and alcoholism;\r\n\r\n          7. Subject has a clinically significant abnormal laboratory test result. Deviations\r\n             considered to be non-clinically significant as per the Principal Investigator are\r\n             acceptable;\r\n\r\n          8. Subject has a history of allergy or sensitivity to amphetamine or components in the\r\n             patch;\r\n\r\n          9. Subject has a history or presence of significant skin disorder such as atopy,\r\n             psoriasis, vitiligo, chronic cutaneous lupus erythematosus (CCLE), or conditions known\r\n             to alter skin appearance (e.g., rash, infection, abnormally dry skin, abrasions),\r\n             presence of tissue scar (e.g., tattoo) or excessive hair, body piercing, presence of\r\n             open sores at the potential site of patch application or skin type that could, in any\r\n             way, confound interpretation of the trial results (i.e., skin type VI on the\r\n             Fitzpatrick scale);\r\n\r\n         10. Subject has a lifetime history of significant dermatologic cancers (e.g., melanoma,\r\n             squamous cell carcinoma), except basal cell carcinomas that were superficial and did\r\n             not involve the application sites;\r\n\r\n         11. Subject with any dermatologic diseases that might interfere with the evaluation of the\r\n             test site reactions;\r\n\r\n         12. Subject has a history of any allergy to soaps, lotions, cosmetics, adhesives, or\r\n             adhesive dressings;\r\n\r\n         13. Subject has a history of significant allergies (including food or drug allergies,\r\n             minor seasonal allergies are allowed);\r\n\r\n         14. Subject with a history of a condition that would significantly influence the immune\r\n             response (e.g., primary or acquired immunodeficiencies such as human immunodeficiency\r\n             virus (HIV) positive or AIDS, allergic diseases such as anaphylaxis, asthma or\r\n             generalized drug reaction, neoplasms such as lymphoma or leukemia, or rheumatoid\r\n             arthritis);\r\n\r\n         15. Subject with a history of severe depression, psychoses, bipolar disorder, mania,\r\n             aggression, marked anxiety, agitation, tension, seizures, Tourette's Syndrome, motor\r\n             tics, glaucoma, migraines, or unexplained syncope;\r\n\r\n         16. Subject is on medications or treatments that would significantly influence or\r\n             exaggerate responses to the test product or that would alter inflammatory or immune\r\n             response to the product (e.g., cyclosporine, tacrolimus, systemic or topical\r\n             corticosteroids, cytotoxic drugs, immune globulin, Bacillus Calmette-Guerin (BCG),\r\n             monoclonal antibodies, radiation therapy) within 3 weeks prior to dosing;\r\n\r\n         17. Subject used any excluded over the counter medications (including herbal remedies)\r\n             that would interfere with the objectives of the study or are contraindicated with the\r\n             study drug for at least 7 days or 4-5 five half-lives, whichever is longer, prior to\r\n             the first dose;\r\n\r\n         18. Subject used monoamine oxidase inhibitors within 14 days of dosing;\r\n\r\n         19. Subject used systemic or topical drugs and analgesics at the patch application site or\r\n             antihistamines within 72 hours prior to dosing or systemic or topical corticosteroids\r\n             within 3 weeks of study enrollment;\r\n\r\n         20. Subject with symptoms of significant acute illness at Screening or prior to dosing;\r\n\r\n         21. Subject with positive screen for hepatitis B and C;\r\n\r\n         22. Subject has been sunbathing, has used a tanning bed within 7 days of the Screening\r\n             Visit or Admission, or has sunburn in the test area that could interfere with skin\r\n             evaluation;\r\n\r\n         23. Subject who could foresee an intensive solar exposure during trial participation (UV\r\n             radiation etc) within 7 to 14 days of the Screening Visit;\r\n\r\n         24. Subject is a Study Investigator, Sub-Investigator, Study Coordinator or is employed by\r\n             the site or the Sponsor, or is an immediate family member (e.g., spouse, parent, child\r\n             or sibling, whether biological or legally adopted) of an employee of the site,\r\n             participating Investigator, CRO or Sponsor;\r\n\r\n         25. Subject has received any investigational product or therapy within 30 days prior to\r\n             study drug administration;\r\n\r\n         26. Any subject not able to meet study requirements in the opinion of the Principal\r\n             Investigator.\r\n      ","sponsor":"Noven Therapeutics","sponsor_type":"Industry","conditions":"Cumulative Irritation and Sensitization","interventions":[{"intervention_type":"Drug","name":"Drug: dATS","description":"d-Amphetamine Transdermal System"}],"outcomes":[{"outcome_type":"primary","measure":"Sensitization","time_frame":"21 days","description":"Number of participants with sensitization potential after repeated exposure to d-ATS, placebo and saline patches in healthy adults"},{"outcome_type":"primary","measure":"Irritation","time_frame":"21 days","description":"Number of participants with skin irritation potential after repeated exposure to d-ATS, placebo and saline patches in healthy adults"}]}
{"nct_id":"NCT04173676","start_date":"2019-12-02","phase":"Phase 1","enrollment":84,"brief_title":"Sentinel Lymph Node Navigation Surgery Using Near-infrared Imaging in Early Esophageal Cancer","official_title":"Sentinel Lymph Node Navigation Using Near-infrared Imaging in Radical Esophagectomy Surgery a Single-arm Clinical Trial","primary_completion_date":"2021-11-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-11-30","last_update":"2021-02-24","description":"The esophageal squamous cell carcinoma (ESCC) has high prevalence and mortality in China, which become a severe challenge for public health. Esophagectomy is the preferred choice for the patients who are diagnosed with ESCC in early stage .Although three-field lymphadenectomy has improved patient survival and reduced tumor recurrence, Surgery-related complications increased dramatically. It has become a research hotspot to find an effective detection method to identify the lymph node metastasis of ESCC and avoid ineffective expanded lymphadenectomy .The molecular imaging technology has been developed for intra-operative visualization and precise resection of the tumors. Indocyanine Green for Injection (ICG) has been used as a contrast agent in the near-infrared imaging system for the surgical navigation technology, which has a relatively positive effect in the clinical application of gastric cancer and liver cancer.There are few reports on the application of ICG near-infrared imaging tracer lymph nodes in the surgery of ESCC. This study intends to identify the detection rate of sentinel lymph node (SLN) and determine the accuracy of regional lymph node metastasis in ESCC by ICG near-infrared imaging technique, which provides clinical evidence for subsequent precise resection of the lymph nodes. This will be one-arm prospective trial. The ESCC patients will be recruited with strict criteria. 84 patients will be enrolled between18 and 75 years old, without gender limit. The submucosal injection of ICG will be performed preoperatively by gastroscopy on the superior and inferior edge of the esophageal tumor. NIR fluorescence imaging will be performed intraoperatively to observe the lymph nodes. The luminescent lymph node is defined as SLN. According to the standard procedure, 3 field lymphadenectomy will be performed, and all the resected lymph nodes will be subjected to pathological analysis including correlation study of fluorescence signal and tumor tissue in pathology slice. This clinical trial is anticipated to evaluate the detection rate of SLN in ESCC with ICG near-infrared fluorescence imaging and determine the accuracy of regional lymph node metastasis.","other_id":"No.ZDWY[2018]LunziNo.(K31-1)","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","intervention_model_description":"The sentinel lymph nodes are observed by submucosal injection of ICG","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. 18 years old  age  75 years old, gender is not limited;\r\n\r\n          2. patient who is diagnosed with ESCC and choose to proceed with surgery\r\n\r\n          3. patient with cTNM stage:T1-3N0-1M0\r\n\r\n          4. tumor located at the middle thoracic or lower thoracic esophagus\r\n\r\n          5. The main organ function is basically normal: Karnofsky score >70%;\r\n\r\n          6. Laboratory blood tests meet surgical standards;\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. pregnancy or breastfeeding\r\n\r\n          2. history of iodide or seafood allergy,\r\n\r\n          3. Patient with occult metastatic disease at the time of surgery\r\n\r\n          4. patient with mental disorder;\r\n\r\n          5. Patient who is simultaneously involved in another clinical trial;\r\n      ","sponsor":"Fifth Affiliated Hospital, Sun Yat-Sen University","sponsor_type":"Other","conditions":"Detection Rate of SLN ; Accuracy Rate of Lymph Node Metastasis","interventions":[{"intervention_type":"Drug","name":"Drug: Indocyanine Green for Injection","description":"The sentinel lymph nodes were observed by submucosal injection of ICG"}],"outcomes":[{"outcome_type":"primary","measure":"the detection rate of sentinel lymph node","time_frame":"through study completion, an average of 1 year","description":"the detection rate of sentinel lymph node in all the enrolled patients"},{"outcome_type":"primary","measure":"The positive rate of sentinel lymph node","time_frame":"through study completion, an average of 1 year","description":"the positive rate of sentinel lymph node in all the enrolled patients"}]}
{"nct_id":"NCT04271800","start_date":"2019-12-01","phase":"Phase 1/Phase 2","enrollment":40,"brief_title":"Safety and Efficacy of CD19-Targeted CAR-T Therapy for Relapsed/Refractory CD19+ B Cell Leukemia and Lymphoma","official_title":"Safety and Efficacy of CD19-Targeted CAR-T Therapy for Relapsed/Refractory CD19+ B Cell Leukemia and Lymphoma","primary_completion_date":"2022-12-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-07-01","last_update":"2021-03-03","description":"This is a single arm study to evaluate the efficacy and safety of CD19-targeted CAR-T cells therapy for patients with relapsed/refractory CD19+ B Cell Leukemia and Lymphoma.","other_id":"PBC014","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":3,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Signed written informed consent;\r\n\r\n          2. Diagnose as relapsed /refractory B Cell Leukemia and Lymphoma, and meet one of the\r\n             following conditions:\r\n\r\n               1. Failed to standard chemotherapy regimens;\r\n\r\n               2. Relapse after complete remission, high-risk and / or refractory patients ;\r\n\r\n               3. Relapse after hematopoietic stem cell transplantation;\r\n\r\n          3. For patients with Ph + ALL, the following conditions must be met: those who have\r\n             received a standard induction chemotherapy regimen and who have not achieved complete\r\n             remission after TKI treatment or have relapsed after remission (cannot tolerate TKI\r\n             treatment or have contraindications to TKI treatment or the presence of TKI class)\r\n             Except for drug resistant patients)\r\n\r\n          4. Evidence for cell membrane CD19 expression;\r\n\r\n          5. All genders, ages: 3 to 75 years\r\n\r\n          6. The expect time of survive is above 12 weeks;\r\n\r\n          7. KPS>60\r\n\r\n          8. No serious mental disorders ;\r\n\r\n          9. Left ventricular ejection fraction 50%\r\n\r\n         10. Sufficient hepatic function defined by ALT/AST3 x ULN and bilirubin2 x ULN;\r\n\r\n         11. Sufficient renal function defined by creatinine clearance2 x ULN;\r\n\r\n         12. Sufficient pulmonary function defined by indoor oxygen saturation92%;\r\n\r\n         13. With single or venous blood collection standards, and no other cell collection\r\n             contraindications;\r\n\r\n         14. Ability and willingness to adhere to the study visit schedule and all protocol\r\n             requirements.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Have received CAR-T therapy or other genetically modified cell therapy before\r\n             screening\r\n\r\n          2. Participated in other clinical research within 1 month before screening\r\n\r\n          3. Have received the following anti-tumor treatment before screening: Have received\r\n             chemotherapy, targeted therapy or other experimental drug treatment within 4 weeks,\r\n             except those who have confirmed disease progression after treatment;\r\n\r\n          4. Live attenuated vaccine within 4 weeks before screening;\r\n\r\n          5. Convulsion or stoke within past 6 months;\r\n\r\n          6. Previous history of other malignancy;\r\n\r\n          7. Presence of uncontrolled active infection;\r\n\r\n          8. Subjects with positive HBsAg or HBcAb positive and peripheral blood HBV DNA titer is\r\n             higher than the lower limit of detection of the research institution; HCV antibody\r\n             positive and peripheral blood HCV RNA titer is higher than the lower limit of\r\n             detection of the research institution; HIV antibody positive; syphilis primary\r\n             screening antibody positive;\r\n\r\n          9. Pregnant or breasting-feeding women;\r\n\r\n         10. Any situation that investigators regard not suitable for attending in this study or\r\n             may affect the data analysis.\r\n      ","sponsor":"Chongqing Precision Biotech Co., Ltd","sponsor_type":"Industry","conditions":"Leukemia|Lymphoma|Leukemia, B-Cell|Leukemia, Lymphocytic, Chronic, B-Cell","interventions":[{"intervention_type":"Biological","name":"Biological: CD19 CAR-T cells","description":"A single infusion of CD19-CAR-T cells will be administered intravenously."}],"outcomes":[{"outcome_type":"primary","measure":"Adverse events that related to treatment","time_frame":"2 years","description":"Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)"},{"outcome_type":"primary","measure":"The response rate of CD19 CAR-T treatment in patients with relapse/refractory CD19+ B Cell Leukemia and Lymphoma that treatment by CD19 CAR-T cells therapy","time_frame":"6 months","description":"The response rate of CD19 CAR-T treatment will be recorded and assessed according to the National Comprehensive Cancer Network Guideline"},{"outcome_type":"secondary","measure":"Rate of CD19 CAR-T cells in bone marrow and peripheral blood","time_frame":"2 years","description":"In vivo (bone marrow and peripheral blood) rate of CD19 CAR-T cells were determined by means of flow cytometry"},{"outcome_type":"secondary","measure":"Quantity of CD19 CAR copies in bone marrow and peripheral blood","time_frame":"2 years","description":"In vivo (bone marrow and peripheral blood) quantity of CD19 CAR copies were determined by means of qPCR"},{"outcome_type":"secondary","measure":"Cellular kinetics of CD19 positive cells in bone marrow","time_frame":"1 years","description":"In vivo (bone marrow) rate and quantity of CD19 positive cells were determined by means of flow cytometry"},{"outcome_type":"secondary","measure":"Levels of Cytokines in Serum","time_frame":"3 months","description":"In vivo (Serum) quantity of cytokines"},{"outcome_type":"secondary","measure":"Duration of Response (DOR) of CD19 CAR-T treatment in patients with refractory/relapsed CD19+ B Cell Leukemia and Lymphoma","time_frame":"2 years","description":"DOR will be assessed from the first assessment of CR/CRi to the first assessment of recurrence or progression of the disease or death from any cause (censored)"},{"outcome_type":"secondary","measure":"Progress-free survival(PFS) of CD19 CAR-T treatment in patients with refractory/relapsed CD19+ B Cell Leukemia and Lymphoma","time_frame":"2 years","description":"PFS will be assessed from the first CAR-T cell infusion to death from any cause or the first assessment of progression (censored)"},{"outcome_type":"secondary","measure":"Overall survival(OS) of CD19 CAR-T treatment in patients with refractory/relapsed CD19+ B Cell Leukemia and Lymphoma","time_frame":"2 years","description":"OS will be assessed from the first CAR-T cell infusion to death from any cause (censored)"}]}
{"nct_id":"NCT04309955","start_date":"2019-12-01","phase":"N/A","enrollment":60,"brief_title":"Modified Versus Traditional Thoracic Drainage After Thoracoscopic Surgery","official_title":"Randomized Clinical Trial of Modified Versus Traditional Thoracic Drainage After Thoracoscopic Surgery for Lung Cancer","primary_completion_date":"2020-04-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2020-04-01","last_update":"2020-03-18","description":"Lung cancer is the leading cause of cancer-related death worldwide. Thoracoscopic pulmonary resection is a prevalent management for early stage of lung cancer. Placement of traditional chest tube is the standard procedure after surgery, which causes pain that cannot be ignored. We aimed to determine whether a modified thoracic drainage strategy based on pigtail catheter associated with better clinical results compared with traditional methods after thoracoscopic surgery for lung cancer.","other_id":"Kli3","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18<age<80;\r\n\r\n          -  Patients with lung cancer;\r\n\r\n          -  Thoracoscopic lung resection;\r\n\r\n          -  Single chest-tube insertion.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  A history of preoperative chemotherapy or radiotherapy;\r\n\r\n          -  Presence of distant tumor metastasis;\r\n\r\n          -  Pneumonectomy;\r\n\r\n          -  Dysfunction of cardiorespiratory system or other surgical contraindications.\r\n      ","sponsor":"Daping Hospital and the Research Institute of Surgery of the Third Military Medical University","sponsor_type":"Other","conditions":"Lung Neoplasms|Lung Cancer|Pulmonary Neoplasm|Postoperative Pain|Thoracoscopic Surgery","interventions":[{"intervention_type":"Procedure","name":"Procedure: pigtail catheter","description":"After inserting the chest tube, add a pigtail catheter into the posterior axillary lines of the 7th intercostal."}],"outcomes":[{"outcome_type":"primary","measure":"Chest tube drainage duration","time_frame":"From date of operation until the date of chest tube removal, assessed up to 7 days","description":"The number of days from operation day to the day of chest tube removal"},{"outcome_type":"primary","measure":"Volume of drainage","time_frame":"From date of operation until the date of removal of the chest tube and pigtail catheter, assessed up to 7 days.","description":"Total volume of thoracic drainage (ml)"},{"outcome_type":"secondary","measure":"Postoperative hospital stay","time_frame":"From date of operation until the date of hospital discharge, assessed up to 30 days.","description":"The numbers of days of patients stay in the hospital after surgery"},{"outcome_type":"other","measure":"Postoperative pain scores","time_frame":"Postoperative day 1, 2, 3, 4 and 5.","description":"Postoperative pain is evaluated by pain scores (0 [No pain] to 10 [Pain as bad as you can endure])"}]}
{"nct_id":"NCT04154020","start_date":"2019-11-30","phase":"N/A","enrollment":50,"brief_title":"Treatment of Ulcers Associated With Hammer, Mallet and Claw Toe Deformities in the Diabetic Patient Setting","official_title":"Treatment of Ulcers Associated With Hammer, Mallet and Claw Toe Deformities in the Diabetic Patient Setting","primary_completion_date":"2021-10-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-10-31","last_update":"2020-10-22","description":"1. Aim Patients with diabetes, hammer, mallet and claw toes and ulcers associated with the named deformities will be randomized to tenotomy (cutting) of flexor tendons to the afflicted toes, done by needle and standard offloading or offloading alone. The effects of the surgery on time to healing of ulcers associated with the named deformities, recurrence of the ulcers, and rate of complications associated with the surgery. In addition to this all patients gait and balance will be examined before start of the study, and after 3 months, to se if there is an effect of the surgery on patients gait and balance. 2. Method A prospective randomized clinical study, which means a study were patients will be allocated randomly to surgery and standard care or standard care alone. Patients will attend a total of up to 14 visits over a 12-month period. 3.","other_id":"TODD II","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Patients who meet all inclusion and no exclusion criteria are randomly allocated to two arms in the study. The allocation is stratified by treatment center.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria\r\n\r\n          -  Patients aged 18 years or above\r\n\r\n          -  Type 1 or 2 diabetes\r\n\r\n          -  Hammer, mallet or claw toe deformity as judged by investigator\r\n\r\n          -  Ulcer associated with above mentioned deformities\r\n\r\n          -  Able to understand written and oral information\r\n\r\n          -  Ability to follow planned visits and treatment\r\n\r\n          -  Able to provide informed consent in Danish and/or English\r\n\r\n        Exclusion Criteria\r\n\r\n          -  Revascularization procedure in the affected limb planned, or undertaken within the 4\r\n             weeks prior to screening\r\n\r\n          -  Hammer, claw and mallet toe that are completely rigid in both MTP and IP joints\r\n\r\n          -  Toe blood pressure lower than 30mmHg\r\n\r\n          -  Infections of the foot ulcer needing surgical treatment\r\n\r\n          -  Prior major amputations on affected or ipsilateral leg\r\n\r\n          -  Other corrective operation is indicated to treat patients foot deformities as deemed\r\n             by investigator\r\n\r\n          -  Current treatment with cytotoxic drugs or with systemically administered\r\n             glucocorticoids\r\n\r\n          -  Treatment of foot ulcers with growth factors, stem cells or equivalent preparations\r\n             within the 8 weeks prior to screening\r\n\r\n          -  Likely inability to comply with the need for planned visits because of planned\r\n             activity\r\n\r\n          -  Participation in another interventional clinical foot ulcer-healing trial within the 4\r\n             weeks prior to screening\r\n\r\n          -  Prior enrolment in this trial\r\n\r\n          -  Judgement by the investigator that the patient does not have the capacity to\r\n             understand the study procedures or provide written informed consent\r\n      ","sponsor":"Steno Diabetes Center Copenhagen","sponsor_type":"Other","conditions":"Diabetic Foot Ulcer|Hammer Toe|Mallet Toe|Claw Toe","interventions":[{"intervention_type":"Procedure","name":"Procedure: Flexor tenotomy","description":"Tenotomy(cutting) of flexor tendons is performed with needle"}],"outcomes":[{"outcome_type":"primary","measure":"Mean time to healing of ulcers(s) in treated limb","time_frame":"Measured at visits (1,3, 5, 7, 9, 10 weeks and 3, 6 and 12 months)","description":"Measured in days"},{"outcome_type":"secondary","measure":"Mean time to healing of incision sites","time_frame":"Measured at visits (1,3, 5, 7, 9, 10 weeks and 3, 6 and 12 months)","description":"Measured in days"},{"outcome_type":"secondary","measure":"Incidence of minor amputations","time_frame":"1 year","description":"Incidence of minor amputations"},{"outcome_type":"secondary","measure":"Incidence of major amputations","time_frame":"1 year","description":"Incidence of major amputations"},{"outcome_type":"secondary","measure":"Plantar pressure profile","time_frame":"3 months","description":"Measured in mmhg from the gait analysis"},{"outcome_type":"secondary","measure":"trembling","time_frame":"3 months","description":"mean COP velocity"},{"outcome_type":"secondary","measure":"Rambling","time_frame":"3 months","description":"measured in COP range and sway path length"},{"outcome_type":"secondary","measure":"incidence of secondary infection","time_frame":"1 year","description":"Incidence of infection during observation period, as demmed by investigator"},{"outcome_type":"secondary","measure":"Pain in treated limb, associated with tenotomy","time_frame":"1 year","description":"Patient reported pain associated with treatment"},{"outcome_type":"secondary","measure":"Transfer lesion incidence","time_frame":"1 year","description":"Transfer lesions defined as impending ulcers or actual ulcers at anatomical sites associated with hammer, mallet and claw toes in patients with diabetes, on non-treated hammer, mallet and claw toes after surgical treatment),"},{"outcome_type":"secondary","measure":"Recurrence of ulcers on the treated limb","time_frame":"1 year","description":"Measured in incidence of recurrent ulcers, defined as ulcer in same anatomical position as treated ulcer after complete healing"},{"outcome_type":"secondary","measure":"Incidence of new ulcers on feet","time_frame":"1 year","description":"Measured in incidence of new ulcers, defined as ulcer in different anatomical position than the treated ulcer(s) and associated with hammer, mallet or claw toes"}]}
{"nct_id":"NCT04297111","start_date":"2019-11-25","phase":"N/A","enrollment":12,"brief_title":"Probiotic-Muscle Study","official_title":"Effect of Bacillus Coagulans on Skeletal Muscle Protein Synthesis in Response to Vegetable Protein Ingestion","primary_completion_date":"2020-06-12","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2021-12-01","last_update":"2020-03-09","description":"This study will examine the effect of probiotic supplementation (Bacillus coagulans) on muscle protein synthesis in older adults in response to a plant-based diet. The investigators hypothesize that probiotic supplementation will enhance the digestibility of plant protein, therefore increasing the proportion of ingested amino acids that appear in systemic circulation and enhancing rates of muscle protein synthesis.","other_id":"IRCEB","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Prevention","masking_description":"Triple","intervention_model_description":"The study will be a randomised, double-blind, placebo-controlled crossover study. Each participant will undergo 8 weeks of Bacillus coagulans (probiotic) supplementation and 8 weeks of placebo supplementation in a counterbalanced order. There will be a 5-day trial period at the end of each supplementation phase. There will be a wash-out period of 8 weeks between probiotic and placebo supplementation.","sampling_method":"","gender":"All","minimum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age: 65 y\r\n\r\n          -  Sex: males and female\r\n\r\n          -  Body mass index (BMI) between 20-35 kg/m2\r\n\r\n          -  Non-smokers\r\n\r\n          -  Generally healthy according to responses to a standard health screening questionnaire\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Cancer (malignancy in the past 5 years)\r\n\r\n          -  CVD\r\n\r\n          -  Chronic kidney disease\r\n\r\n          -  Liver failure\r\n\r\n          -  Diabetes or pre-diabetes\r\n\r\n          -  Conditions that will affect the ability to consume, digest and/or absorb the study\r\n             supplement (i.e. gastrointestinal disease)\r\n\r\n          -  Smokers\r\n\r\n          -  Excess alcohol intake\r\n\r\n          -  Regular resistance training\r\n\r\n          -  Total walking incapacity\r\n\r\n          -  Musculoskeletal or neuromuscular impairments\r\n\r\n          -  Medications interfering with muscle metabolism\r\n\r\n          -  Ongoing probiotic supplementation\r\n\r\n          -  Antibiotic use in the previous 6 weeks\r\n\r\n          -  Significant body mass loss in the 1 month period prior to the study\r\n      ","sponsor":"University College Dublin","sponsor_type":"Other","conditions":"Old Age; Debility|Muscle Weakness|Protein Deregulation|Protein Deposition","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Probiotic","description":"GanedenBC30 (Bacillus coagulans GBI-30, 6086) capsule made of 1 billion colony forming units (cfu). Description: pure cell mass of an L-(+) lactic acid-producing, gram-positive, spore-forming shaped bacterium that is aerobic to microaerophilic. Maltodextrin used as filler."},{"intervention_type":"Other","name":"Other: Placebo","description":"Maltodextrin capsule, no active ingredient"}],"outcomes":[{"outcome_type":"primary","measure":"Myofibrillar protein synthesis","time_frame":"6 months","description":"Measured as fractional synthetic rate (%/day) over a 2-d period after each supplementation arm and in response to a plant-based diet"},{"outcome_type":"primary","measure":"Pattern of change in plasma total amino acid, essential amino acid and leucine concentrations","time_frame":"6 months","description":"Assessed via GC-MS."},{"outcome_type":"secondary","measure":"Changes in microbiome composition","time_frame":"6 months","description":"Assessed in faecal samples via 16s rRNA analysis"},{"outcome_type":"secondary","measure":"Change in metabolome","time_frame":"6 months","description":"Assesed in blood and faecal water via 600 MHz nuclear magnetic resonance (NMR) spectrometry"},{"outcome_type":"secondary","measure":"Changes in gut hormones","time_frame":"6 months","description":"ELISA (enzyme-linked immunosorbent assay)"},{"outcome_type":"secondary","measure":"Changes in gut/digestion-related complaints","time_frame":"6 months","description":"Assessed via the Gastrointestinal Symptom Rating Scale (GSRS), where minimum and maximum values are: no discomfort at all, and very severe discomfort respectively (higher score means worse outcome)."},{"outcome_type":"secondary","measure":"Changes in bowel movement","time_frame":"6 months","description":"Assessed via the Bristol Stool chart, where average faecal appearance is indicated out of seven options available"},{"outcome_type":"secondary","measure":"Changes in strength","time_frame":"6 months","description":"Assessed via handgrip strength using a handgrip dynamometer"},{"outcome_type":"secondary","measure":"Changes in immuno-surveillance","time_frame":"6 months","description":"Assessed via the Common Cold Questonnaire (CCQ), where minimum and maximum values are: none, and severe respectively (higher score means worse outcome)."},{"outcome_type":"secondary","measure":"Changes in appetite","time_frame":"6 months","description":"Assessed via the Visual Analogue Scale (VAS) during 3 days of the trial period and after the protein-containing beverage, where the left and right side of the scale indicate: not hungry at all, and extremely hungry respectively (there is not an assigned better or worse outcome for this scale)"}]}
{"nct_id":"NCT04154124","start_date":"2019-11-23","phase":"N/A","enrollment":20,"brief_title":"Applying PET/MR in Rectal Cancer.","official_title":"Applying PET/MR in Rectal Cancer.","primary_completion_date":"2020-12-23","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2021-12-23","last_update":"2019-11-06","description":"The use of the novel recently introduced PET/MR scanner is believed to be promising in RC management, providing great anatomical details and detailed metabolic characterization. Preliminary data indicate it may become a strong imaging modality for staging of RC and has the potential to be used as a predictive tool guiding individualized therapy in patients receiving nT, but confirmation on prospective studies is mandatory. The use of radiomics as analysis approach may assist in achieving a better understanding of the obtained image data, and thus a more accurate disease assessment. Objectives 1. To preliminary assess the potential diagnostic value of single PET/MR scan in RC staging and compare it to that of MRI alone, PET/CT alone, and combined MRI and PET/CT. 2. To preliminary assess the potential value of PET/MR in predicting pMR to nT. 3. To use radiomics analysis of PET/MR data to develop a quantification clinical tools that allow a more accurate and comprehensive assessment of RC patients.","other_id":"TASMC-19-ES-0448-CTIL","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":120,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        1.Patients with newly diagnosed RC; histopathological confirmation of adenocarcinoma of\r\n        colorectal origin.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients younger than 18 years;\r\n\r\n          2. pregnancy;\r\n\r\n          3. other known active malignancy;\r\n\r\n          4. previous chemotherapy or radiotherapy;\r\n\r\n          5. previous pelvic operation;\r\n\r\n          6. patient that no intent / not suited for neoadjuvant therapy (including metastatic\r\n             disease at presentation); contraindication to intravenous contrast agents.\r\n      ","sponsor":"Tel-Aviv Sourasky Medical Center","sponsor_type":"Other","conditions":"Rectal Cancer","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: PET/MR scan","description":"whole-body PET/CT scan and pelvic PET/MR scan (MR protocol will include three plane fast spin echo T2 weighted, DWI and dynamic contrast enhanced imaging). The ad interim assessment will use a pelvic PET/MR scan only (without PET/CT), to avoid the radiation associated with whole body CT. In the staging and post-nT assessment, the addition of PET/MR to the standard use of PET/CT adds no radiation exposure."}],"outcomes":[{"outcome_type":"primary","measure":"Number of patient that shown the different between diagnostic value of single PET/MR scan in RC staging and compare it to that of MRI alone, PET/CT alone, and combined MRI and PET/CT","time_frame":"1 year"}]}
{"nct_id":"NCT04081987","start_date":"2019-11-20","enrollment":50,"brief_title":"Evaluation and Calibration of a Novel Non-invasive Wearable Device for Monitoring Vital Signs","official_title":"A Multi-center, Prospective, Pilot Study Intended for Data Collection to Evaluate and Calibrate a Novel Non-invasive Wearable Device for Monitoring Vital Signs","primary_completion_date":"2020-01-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2020-03-31","last_update":"2020-01-14","description":"The purpose of this clinical study is to compare the measurement of vital signs (blood pressure, heart rate, respiration rate, blood oxygen levels and body temperature) measured by the non-invasive, continuous and wireless BiPS monitoring device with vital signs measured by current standard of care hospital equipment (blood pressure measurements will be obtained from arterial line) an invasive arterial line. The study will be conducted in two medical centers in Israel and include 50 adult patients that are connected to an arterial line as part of their routine care.","other_id":"BiPS","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"The study will include a total of 50 adult patients that are connected to an arterial line\r\n        as part of their routine care (e.g., post operative cardiac patients, or intensive care\r\n        unit patients), recruited in Sourasky Medical Center (Ichilov), Tel-Aviv and Carmel Medical\r\n        Center, Haifa.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients aged 18 years and older who agree to sign an informed consent.\r\n\r\n          -  Patients connected to an arterial line as part of their routine care (e.g., patients\r\n             recovering from cardiac or other major surgery)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnant women.\r\n\r\n          -  Patients under the age of 18.\r\n\r\n          -  Patients who are not connected to an arterial line as part of their routine care.\r\n\r\n          -  Unable to give informed consent.\r\n\r\n          -  Patients with poor or no finger pulse.\r\n      ","sponsor":"BiPS Medical","sponsor_type":"Industry","conditions":"Post-cardiac Surgery|Intensive Care Unit Patients","interventions":[{"intervention_type":"Device","name":"Device: non-invasive monitoring","description":"Comparing blood pressure (diastolic & systolic), heart and respiration rates, blood oxygen level and body temperature measurement using the BiPS non-invasive monitor to an arterial line."}],"outcomes":[{"outcome_type":"primary","measure":"Level of accordance between the BiPS monitor and the arterial line","time_frame":"60 minutes","description":"Correlation between the vital sgns measured on The BiPS non-invasive monitor and those measured through the arterial line"}]}
{"nct_id":"NCT04174781","start_date":"2019-11-20","phase":"Phase 2","enrollment":61,"brief_title":"Neoadjuvant Therapy for Hepatocellular Carcinoma","official_title":"Neoadjuvant Therapy for BCLC Stage A/B Hepatocellular Carcinoma Beyond Milan Criteria: An Exploratory Clinical Trail","primary_completion_date":"2020-11-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-05-30","last_update":"2019-11-26","description":"This study aimed to evaluate the efficacy and the safety of the anti-programmed-death-1 antibody (anti-PD-1) Sintilimab Injection in combination with transarterial chemoembolization with drug-eluting beads(TACE-DEB) in patients with early and intermediate stage hepatocellular carcinoma (HCC) who isn't suitable for primary surgical resection.","other_id":"CISLD-5","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"A Phase II Single-arm, Open-label Study","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Newly histologically confirmed diagnosis of HCC or strictly consistent with the\r\n             clinical diagnostic criteria for HCC according to AASLD guideline\r\n\r\n          2. At least one measurable site of disease as defined by modified RECIST (mRECIST)\r\n             criteria with spiral CT scan or MRI and has not received local treatment\r\n\r\n          3. Patients with BCLC stage A but beyond Milan Criteria and BCLC stage B\r\n\r\n          4. Patients should be discussed in multidisciplinary teams and are not eligible for\r\n             primary resection or local ablation, and tumor burden below 50% of liver volume\r\n\r\n          5. ECOG PS score: 0~1 points; Child-Pugh A or B (<=7)\r\n\r\n          6. Life expectancy of at least 3 months;\r\n\r\n          7. Subjects with chronic HBV infection must be on antiviral therapy per regional standard\r\n             of care guidelines prior to initiation of study therapy\r\n\r\n          8. Adequate blood count, liver-enzymes, and renal function: laboratory test values meet\r\n             the following requirements within 7 days prior to enrollment (no blood components,\r\n             cell growth factors, albumin and other corrective therapy drugs are allowed within 14\r\n             days prior to laboratory test):\r\n\r\n               1. absolute neutrophil count, ANC1.510^9/L, platelet, PLT8010^9/L, hemoglobin,\r\n                  HGB8.5 g/dL;\r\n\r\n               2. total bilirubin, TBIL1.5ULN, alanine aminotransferase, ALT and aspartate\r\n                  transferase, AST5ULN, serum Alb28 g/L\r\n\r\n               3. creatinine, Cr  1.5ULN or clearance of creatinine, CCr 50mL/min, Urine\r\n                  protein<2+;\r\n\r\n               4. INR 2 and APTT 1.5ULN.\r\n\r\n        11. Female patients with reproductive potential must have a negative urine or serum\r\n        pregnancy test within 7 days prior to start of trial 10. Patients agreed to join the\r\n        clinical trial and signed informed consent and are willing and able to comply with the\r\n        protocol for the duration of the study including undergoing treatment, adherence to\r\n        contraceptive measures, scheduled visits and examinations including follow up.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Active tuberculosis (TB), who are receiving anti-TB treatment or who received anti-TB\r\n             treatment within 1 year prior to the first studyPatients with previous or current\r\n             objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis,\r\n             radiation pneumonia, drug-related pneumonia, and severe impairment of lung function.\r\n\r\n          2. Patients With II-IV myocardial ischemia and myocardial infarction, poor control of\r\n             cardiac arrhythmias; Patients with hypertension who cannot be reduced to the normal\r\n             range after antihypertensive medication (systolic blood pressure > 140 mmHg, diastolic\r\n             blood pressure > 90 mmHg).\r\n\r\n          3. A history of gastrointestinal perforations and/or fistulas, intestinal obstruction\r\n             (including incomplete intestinal obstruction requiring parenteral nutrition),\r\n             inflammatory bowel disease or extensive bowel resection (partial colectomy or\r\n             extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative\r\n             colitis, or chronic diarrhea within 6 months; Patients with a history of\r\n             gastrointestinal bleeding or a clear gastrointestinal bleeding tendency in the past 6\r\n             months, such as esophageal varices with bleeding risk, local active ulcer lesions, and\r\n             fecal occult blood (++).\r\n\r\n          4. Severe bleeding tendency or coagulation dysfunction, or receiving thrombolytic\r\n             treatment; Any life-threatening bleeding event that has occurred within the previous 6\r\n             months, including the need for blood transfusion, surgery or topical treatment, and\r\n             continued medication.\r\n\r\n          5. Autoimmune disease requiring systematic treatment or a history of the disease within 2\r\n             years. (such as vitiligo, psoriasis, hair loss or graves' disease).\r\n\r\n          6. Patients with central nervous system diseases (such as primary brain tumors, stroke,\r\n             epilepsy, etc.) or central nervous system metastasis or known brain metastasis.\r\n\r\n          7. Acute or chronic active hepatitis B or C infection; Human immunodeficiency virus (HIV)\r\n             infection (HIV 1/2 antibody positive); . A severe infection that is active or\r\n             clinically poorly controlled. Severe infections, including but not limited to\r\n             hospitalization for infection, bacteremia, or complications of severe pneumonia,\r\n             occurred 1 month before the first study.\r\n\r\n          8. Contains fibroblastic layer hepatocellular carcinoma, sarcomatoid hepatocellular\r\n             carcinoma, bile duct carcinoma and other components; Other malignancies were diagnosed\r\n             within 5 years prior to the first administration, excluding radical basal cell\r\n             carcinoma of the skin, skin squamous cell carcinoma and/or radical resection of\r\n             carcinoma in situ. If other malignancies or liver cancer are diagnosed more than 5\r\n             years before administration, a pathological or cytological diagnosis of the relapsed\r\n             and metastatic lesions is required.\r\n\r\n          9. Previous major surgery (craniotomy, thoracotomy, or laparotomy) within 1 month or\r\n             unhealed wounds, ulcers, or fractures; Severe arteriovenous fistula; Uncontrolled\r\n             metabolic disorders or other non-malignant organ or systemic disease or cancer\r\n             secondary reactions and may result in higher medical risk and/or uncertainty in\r\n             survival evaluation.\r\n\r\n         10. Treated with immunosuppressive drugs, live attenuated vaccine, systemic\r\n             immunostimulant therapy, or any anti-PD-1, anti-PD-L1/L2 antibody or other\r\n             immunotherapy and experimental drugs within 4 weeks or planned during the study\r\n             period.\r\n\r\n         11. Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities\r\n             that may increase the risk of study participation or administration of the study drug,\r\n             or interfere with the interpretation of the study results, and classify patients as\r\n             ineligible to participate in the study at the discretion of the investigator.\r\n\r\n         12. Patients with a history of hepatic encephalopathy or a history of liver\r\n             transplantation or patients preparing for liver transplantation; Pregnant or lactating\r\n             women; Known to be allergic to any antibody-targeted drug or small-molecular-targeted\r\n             drug ingredient; Or have a history of severe allergic reactions to other monoclonal\r\n             antibodies.\r\n      ","sponsor":"Zhejiang University","sponsor_type":"Other","conditions":"Hepatocellular Carcinoma","interventions":[{"intervention_type":"Drug","name":"Drug: Sintilimab Injection","description":"Sintilimab therapy combined with standard TACE-DEB treatment"},{"intervention_type":"Drug","name":"Drug: TACE","description":"TACE is performed by using drug eluting beads"}],"outcomes":[{"outcome_type":"primary","measure":"Progression-Free Survival (PFS)","time_frame":"Observation period 36 months","description":"Time from first TACE-DEB treatment to first typical disease progression, or death, which occurred earlier"},{"outcome_type":"secondary","measure":"Objective Response Rate (ORR)","time_frame":"36 months","description":"Efficacy included objective response (includes complete and partial response) according to modified RECIST for HCC"},{"outcome_type":"secondary","measure":"Duration of Response (DOR)","time_frame":"36 months","description":"Time between the date of first radiographic documented objective response according to mRECIST for HCC and the date of the radiographic disease progression."},{"outcome_type":"secondary","measure":"Overall survival (OS)","time_frame":"36 months","description":"Time from first TACE-DEB treatment until death"},{"outcome_type":"secondary","measure":"Major Pathological response rate（MPR）","time_frame":"36 months","description":"Number of participants experiencing the percentage of the non-viable cancer cells (necrotized or fibrotized) out of the surface expression of the total tumor area is <10%"},{"outcome_type":"secondary","measure":"R0 resection rate","time_frame":"36 months","description":"Number of participants experiencing R0 resection"},{"outcome_type":"secondary","measure":"Adverse events","time_frame":"36 months","description":"Safety evaluation was done continuously during treatment by using CTCAE 5.0"}]}
{"nct_id":"NCT04144803","start_date":"2019-11-18","enrollment":1300,"brief_title":"Brain Oxygenation During Prehospital Anesthesia: an Observational Study","official_title":"Brain Oxygenation During Prehospital Anesthesia: an Observational Study (The BOPRA Study)","primary_completion_date":"2021-12-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2022-12-31","last_update":"2021-02-16","description":"Brain oxygenation of adult patients undergoing prehospital emergency anesthesia is monitored using noninvasive near-infrared spectroscopy. Patients are afterwards interviewed to define neurological outcome to measure quality of life. The purpose of this study is to reveal the risk factors of prehospital anesthesia related cerebral desaturation events (CDE) and to define the association between CDE and survival, neurological outcome or quality of life.","other_id":"BOPRA","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Adult patients undergoing prehospital anesthesia and endotracheal intubation regardless of\r\n        indication","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  sedation or anesthesia provided to facilitate endotracheal intubation, performed by\r\n             Helicopter Emergency Medical Services (HEMS) team regardless of the reason\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Ongoing cardiopulmonary resuscitation at the time of intubation\r\n\r\n          -  Physical barrier for near-infrared spectroscopy measuring (e.g. forehead laceration)\r\n\r\n          -  HEMS unit does not escort patient to the hospital (exception: in case of death on\r\n             scene after inclusion, patient is included)\r\n\r\n          -  Workload too high to ensure standard level of clinical care during the study\r\n\r\n          -  For interviews: no competence in Finnish, Swedish or English\r\n      ","sponsor":"Helsinki University Central Hospital","sponsor_type":"Other","conditions":"Critically Ill|Major Trauma|Anesthesia|Emergencies","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Cerebral near-infrared spectroscopy","description":"Nonin H500 one-channel near-infrared spectroscopy monitor on forehead of the patient from before induction of anesthesia to arrival to hospital"}],"outcomes":[{"outcome_type":"primary","measure":"Favorable neurological outcome","time_frame":"30 days","description":"modified Rankin scale ≤2 (scale 0-6, 0 asymptomatic, 6 expired)"},{"outcome_type":"primary","measure":"Cerebral desaturation event","time_frame":"through prehospital care, approximately 60 minutes","description":"an absolute drop of forehead cerebral saturation ≥ 10% from baseline for ≥ 5 minutes"},{"outcome_type":"secondary","measure":"Survival","time_frame":"30 days","description":"Survival"},{"outcome_type":"secondary","measure":"Survival","time_frame":"365 days","description":"Survival"},{"outcome_type":"secondary","measure":"Favorable neurological outcome","time_frame":"1 year","description":"modified Rankin scale ≤2 (scale 0-6, 0 asymptomatic, 6 expired)"},{"outcome_type":"secondary","measure":"15D score","time_frame":"1 year","description":"Heal-Related Quality of Life measured using 15-D instrument, scale 0-1 (0 = being dead, 0.0162 = being unconscious or comatose, 1 = no problems on any dimension = 'full' HRQOL)"}]}
{"nct_id":"NCT04176042","start_date":"2019-11-18","phase":"N/A","enrollment":28,"brief_title":"Community-Level Daytime Sleepiness: Social-Environmental Determinants, Consequences, and Impact of Sleep Apnea","official_title":"Community-Level Daytime Sleepiness: Social-Environmental Determinants, Consequences, and Impact of Sleep Apnea","primary_completion_date":"2020-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-06-30","last_update":"2020-12-21","description":"The purpose of this study is to examine daytime sleepiness in a community context. This includes examining sleepiness in a large sample in terms of social/behavioral/environmental predictors and health-related outcomes, as well as examining the role of a sleep education intervention in a smaller sample for promoting healthy beliefs/attitudes about sleepiness.","other_id":"1906742940","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Basic Science","masking_description":"Single","intervention_model_description":"4-WEEK TRACKS All 28 participants will be randomized to one of two 4-week tracks (N=14 each). The study design (crossover) dictates that all participants must complete a questionnaire at identical time points; therefore, participants in track 2 will perform a baseline questionnaire at the same time as track 1 participants perform a baseline questionnaire for their intervention. Also, participants in track 1 will complete the follow up at the same time as track 2 participants perform a baseline questionnaire for their intervention.","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        To be included in the study trial, subjects must:\r\n\r\n          -  Subject is a male or female, 20-60 years of age, inclusive.\r\n\r\n          -  Subject is not pregnant.\r\n\r\n          -  Subject obtains a score of >10 on the Epworth Sleepiness Scale, indicating high\r\n             daytime sleepiness.\r\n\r\n          -  Subject presents no apparent unstable and/or major medical or psychiatric conditions\r\n             that may contribute to sleepiness.\r\n\r\n          -  Subject is fluent in English.\r\n\r\n          -  Subject is willing to take part in this study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subject is under the age of 20 or over the age of 60.\r\n\r\n          -  Subject is pregnant.\r\n\r\n          -  Subject presents apparent unstable and/or major medical or psychiatric conditions that\r\n             may contribute to sleepiness.\r\n\r\n          -  Subject is not fluent in English.\r\n\r\n          -  Subject obtained a score of <10 on the Epworth Sleepiness Scale.\r\n      ","sponsor":"University of Arizona","sponsor_type":"Other","conditions":"Daytime Sleepiness","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Track 1","description":"Intervention + Follow-up"},{"intervention_type":"Behavioral","name":"Behavioral: Track 2","description":"Wait list + Intervention"}],"outcomes":[{"outcome_type":"primary","measure":"Change of Epworth Sleepiness Scale (ESS) score across specific time points for Track 1","time_frame":"Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to follow up (after 4 weeks).","description":"ESS is a standard measure to assess daytime sleepiness and consists of 8 items ranging from \"No chance of dozing\" to \"High chance of dozing\" that evaluate sleep propensity in a range of situations."},{"outcome_type":"primary","measure":"Change of Epworth Sleepiness Scale (ESS) score across specific time points for Track 2","time_frame":"Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to pre-intervention (after 4 weeks).","description":"ESS is a standard measure to assess daytime sleepiness and consists of 8 items ranging from \"No chance of dozing\" to \"High chance of dozing\" that evaluate sleep propensity in a range of situations."},{"outcome_type":"primary","measure":"Changes in Sleep Practices and Attitudes Questionnaire (SPAQ) score for Track 1","time_frame":"Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to immediately post-intervention (2 hours), and to follow up (after 4 weeks)","description":"This questionnaire assesses habitual sleep behaviors associated with sleep and potential sleep problems."},{"outcome_type":"primary","measure":"Changes in Sleep Practices and Attitudes Questionnaire (SPAQ) score for Track 2","time_frame":"Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to pre-intervention (after 4 weeks), and to immediately post-intervention (2 hours)","description":"This questionnaire assesses habitual sleep behaviors associated with sleep and potential sleep problems."},{"outcome_type":"primary","measure":"Changes in Sleep Beliefs Scale (SBS) score for Track 1","time_frame":"Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to immediately post-intervention (2 hours), and to follow up (after 4 weeks)","description":"The SBS is a revised version of the Sleep Hygiene Awareness and Practice Scale. Possessing a simplified scoring method, the SBS consists of the nine most salient questions from the previous scale, along with 11 relevant additions. The scale requires respondents to indicate how certain behaviors (e.g., drug consumption, daytime and evening activities) can influence the quality and quantity of an individual's sleep, with answers ranging from \"positive effect\" (on sleep) to \"negative effect\" (on sleep)."},{"outcome_type":"primary","measure":"Changes in Sleep Beliefs Scale (SBS) score for Track 2","time_frame":"Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to pre-intervention (after 4 weeks), and to immediately post-intervention (2 hours)","description":"The SBS is a revised version of the Sleep Hygiene Awareness and Practice Scale. Possessing a simplified scoring method, the SBS consists of the nine most salient questions from the previous scale, along with 11 relevant additions. The scale requires respondents to indicate how certain behaviors (e.g., drug consumption, daytime and evening activities) can influence the quality and quantity of an individual's sleep, with answers ranging from \"positive effect\" (on sleep) to \"negative effect\" (on sleep)."},{"outcome_type":"primary","measure":"Changes in Dysfunctional Beliefs About Sleep Scale score for Track 1","time_frame":"Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to immediately post-intervention (2 hours), and to follow up (after 4 weeks)","description":"Consisting of 28 items, the scale evaluates sleep-related beliefs, querying respondents' expectations and attitudes regarding the causes, consequences, and potential treatments of sleep issues, with answers ranging from 0-\"Strongly Disagree\" to 10-\"Strongly Agree\"."},{"outcome_type":"primary","measure":"Changes in Dysfunctional Beliefs About Sleep Scale score for Track 2","time_frame":"Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to pre-intervention (after 4 weeks), and to immediately post-intervention (2 hours)","description":"Consisting of 28 items, the scale evaluates sleep-related beliefs, querying respondents' expectations and attitudes regarding the causes, consequences, and potential treatments of sleep issues, with answers ranging from 0-\"Strongly Disagree\" to 10-\"Strongly Agree\"."},{"outcome_type":"secondary","measure":"Qualitative Themes in Sleep Beliefs (Discussed in a group setting)","time_frame":"Focus Group [Day 0]","description":"Focus Group to gather qualitative themes guided by the following questions:\r\nWhat is healthy sleep?\r\nWhat is unhealthy sleep?\r\nWhat is sleepiness?\r\nHow does sleepiness affect you?\r\nWhat is the most important thing about your sleepiness?\r\nWhat do you do about your sleepiness?"},{"outcome_type":"secondary","measure":"Demographics and Personal Information","time_frame":"Track 1: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to follow up (after 4 weeks). Track 2: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to pre-intervention (after 4 weeks).","description":"This measure includes questions about age, sex, education level, relationship status, employment, status, and race/ethnicity."},{"outcome_type":"secondary","measure":"Medical History","time_frame":"Track 1: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to follow up (after 4 weeks). Track 2: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to pre-intervention (after 4 weeks).","description":"Self-report questions about medical history, including family medical history"},{"outcome_type":"secondary","measure":"Fatigue Severity Scale (FSS)","time_frame":"Track 1: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to follow up (after 4 weeks). Track 2: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to pre-intervention (after 4 weeks).","description":"FSS is a well-validated 9-item clinical measure that assesses overall levels of mental and physical fatigue, with answers ranging from 1- \"Strongly Disagree\" to 7-\"Strongly Agree\"."},{"outcome_type":"secondary","measure":"Sleep Timing Questionnaire (STQ)","time_frame":"Track 1: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to follow up (after 4 weeks). Track 2: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to pre-intervention (after 4 weeks).","description":"STQ assesses weekday and weekend sleep timing and sleep duration, as well as variability in sleep timing, with responses in the form of # of minutes (i.e. 25 minutes) or hourly times (i.e. 7:00 pm)."},{"outcome_type":"secondary","measure":"Insomnia Severity Index (ISI)","time_frame":"Track 1: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to follow up (after 4 weeks). Track 2: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to pre-intervention (after 4 weeks).","description":"ISI is a brief (7-item) insomnia screening tool that is the gold standard for quantifying severity of clinical insomnia symptoms."},{"outcome_type":"secondary","measure":"Sleep Disorders Symptom Check List","time_frame":"Track 1: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to follow up (after 4 weeks). Track 2: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to pre-intervention (after 4 weeks).","description":"a 20 question instrument was developed to screen for six sleep disorders (insomnia, obstructive sleep apnea, restless legs syndrome/periodic limb movement disorder, circadian rhythm sleep-wake disorders, narcolepsy, and parasomnias) and evaluated psychometrically. Answers range from \"Never\" to \">5 times a week\" ."},{"outcome_type":"secondary","measure":"Patient Health Questionnaire (PHQ9)","time_frame":"Track 1: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to follow up (after 4 weeks). Track 2: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to pre-intervention (after 4 weeks).","description":"The PHQ9 will screen for depression symptoms. It is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression: It incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool. Participants with a score >9 will be excluded. A total score is calculated for this tool."},{"outcome_type":"secondary","measure":"Generalized Anxiety Disorder 7- Item Scale (GAD-7)","time_frame":"Track 1: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to follow up (after 4 weeks). Track 2: Changes from Baseline (approximately 7 days after Focus Group [Day 0]) to pre-intervention (after 4 weeks).","description":"is a self-reported questionnaire for screening and severity measuring of generalized anxiety disorder. It contains 7 items with answers ranging from \"Not at all\" to \"Nearly every day\"."}]}
{"nct_id":"NCT04128085","start_date":"2019-11-15","phase":"Phase 1","enrollment":30,"brief_title":"A Study to Evaluate the Tolerance and Pharmacokinetics of TQB3804 in Subjects With Advanced Malignant Tumors","official_title":"A Phase I, Open-label, Multicenter, Dose Escalation and Expansion Study to Evaluate the Tolerance and Pharmacokinetics of TQB3804 in Subjects With Advanced Malignant Tumors","primary_completion_date":"2020-10-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-10-31","last_update":"2019-12-16","description":"This is a study to evaluate the tolerance, dose-limiting toxicity (DLT), phase II recommended dose (RP2D), and maximum tolerated dose (MTD) of single and multiple oral doses of TQB3804 in patients with advanced malignant tumors.","other_id":"TQB3804-I-01","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        - 1. Understood and signed an informed consent form. 2. 18 and 70 years old. 3.\r\n        Histologically or cytologically confirmed advanced malignant tumor. 4. Has EGFR mutations.\r\n        5. Life expectancy 12 weeks. 6. Eastern Cooperative Oncology Group (ECOG) performance\r\n        status score of 0 to 2.\r\n\r\n        7.Adequate organ system function. 8.At least one measurable lesion.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  1.Hypersensitivity to TQB3804 or its excipient. 2. Has diagnosed and/or treated\r\n             additional malignancy within 5 years with the exception of cured carcinoma in situ of\r\n             the cervixintramucosal carcinoma of gastrointestinal tractbreast and non-melanoma\r\n             skin cancers and superficial bladder tumors.\r\n\r\n             3.Has interstitial pneumonia. 4.Brain metastases with symptom . 5.Has currently\r\n             uncontrollable congestive heart failure. 6.Has history of arterial thromboembolism\r\n             within 6 months. 7.Has any bleeding tendency or coagulopathy within 6 months. 8.Has\r\n             skin toxicity  grade 2 within 4 weeks. 9.Has serious gastrointestinal diseases within\r\n             4 weeks. 10.Has received any major surgery within 4 weeks. 11.Participated in other\r\n             clinical trials within 4 weeks. 12.Has active viral, bacterial and fungal infections\r\n             within 4 weeks. 13.Has received any cancer therapy within 4 weeks or 5 times of t1/2.\r\n             14.Has  grade 2 toxicity caused by previous anti-tumor treatment. 15. HBsAg positive\r\n             and HBV DNA positive (ULN);HCV antibody and HCV-RNA positive (ULN); HIV positive or\r\n             HIV ULN.\r\n\r\n             16. Has multiple factors affecting oral medication. 17. Breastfeeding or pregnant\r\n             women.; Men unwilling to use adequate contraceptive measures during the study.\r\n\r\n             18. According to the judgement of the researchers, there are other factors that\r\n             subjects are not suitable for the study.\r\n      ","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","sponsor_type":"Industry","conditions":"Advanced Malignant Tumors","interventions":[{"intervention_type":"Drug","name":"Drug: TQB3804","description":"A kind of tyrosine kinase inhibitor."}],"outcomes":[{"outcome_type":"primary","measure":"Dose-limiting toxicity (DLT)","time_frame":"Baseline up to 28 days","description":"Subjects appear the following toxic reaction relate to the drug after treatment within 28 days ：III °or above of non-hematological toxicity, IV° hematological toxicity , neutropenia associated with fever."},{"outcome_type":"secondary","measure":"Cmax","time_frame":"Hour 0, 1, 2, 4, 6, 8, 10, 12, 18, 24, 48, 72, 96, 168 hours post-dose on single dose; Hour 0 of day 8,day 15,day14,day 22,day 28 on multiple dose and Hour 0, 1, 2, 4, 6, 8, 10, 12, 18, 24 hours post-dose on multiple dose of day 28.","description":"Cmax is the maximum plasma concentration of TQB3804 or metabolite(s)."},{"outcome_type":"secondary","measure":"Tmax","time_frame":"Hour 0, 1, 2, 4, 6, 8, 10, 12, 18, 24, 48, 72, 96, 168 hours post-dose on single dose; Hour 0 of day 8,day 15,day14,day 22,day 28 on multiple dose and Hour 0, 1, 2, 4, 6, 8, 10, 12, 18, 24 hours post-dose on multiple dose of day 28.","description":"To characterize the pharmacokinetics of TQB3804 by assessment of time to reach maximum plasma concentration."},{"outcome_type":"secondary","measure":"AUC0-t","time_frame":"Hour 0, 1, 2, 4, 6, 8, 10, 12, 18, 24, 48, 72, 96, 168 hours post-dose on single dose; Hour 0 of day 8,day 15,day14,day 22,day 28 on multiple dose and Hour 0, 1, 2, 4, 6, 8, 10, 12, 18, 24 hours post-dose on multiple dose of day 28.","description":"To characterize the pharmacokinetics of TQB3804 by assessment of area under the plasma concentration time curve from zero to infinity."},{"outcome_type":"secondary","measure":"Progression Free Survival (PFS)","time_frame":"Baseline up to 52 weeks","description":"PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause."},{"outcome_type":"secondary","measure":"Objective Response Rate(ORR)","time_frame":"Baseline up to 52 weeks","description":"Percentage of participants achieving complete response (CR) and partial response (PR)."},{"outcome_type":"secondary","measure":"Disease Control Rate(DCR)","time_frame":"Baseline up to 52 weeks","description":"Percentage of participants achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD)."}]}
{"nct_id":"NCT04114123","start_date":"2019-11-13","enrollment":2500,"brief_title":"The Development of Reward Response to Food in Infancy","official_title":"The Development of Reward Response to Food in Infancy","primary_completion_date":"2024-10-01","study_type":"Observational","rec_status":"Recruiting","completion_date":"2024-10-01","last_update":"2020-10-28","description":"In this study the researchers want to learn more about reward-driven eating behavior in children ages 2 to 24 months. The researchers hope to use this knowledge to help inform obesity prevention programs.","other_id":"HUM00164906","observational_model":"Cohort","time_perspective":"Other","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"The researchers will enroll infants and their mothers (age limit given is for minimum age\r\n        for mothers) from the community and from sites allowed and approved by the IRB like\r\n        pediatric clinics and childcare centers. They will be recruiting participants living within\r\n        a 50 mile radius around Ann Arbor, MI.","criteria":"\n        For the Longitudinal Arm:\r\n\r\n        Inclusion Criteria\r\n\r\n          -  Baby is alive\r\n\r\n          -  Baby is 6 to 12 weeks old at time of enrollment\r\n\r\n          -  Baby and mother receive care at Michigan Medicine, and specifically:\r\n\r\n               -  Baby was born at Michigan medicine\r\n\r\n               -  Baby has had a 2 month well child check\r\n\r\n               -  Mother received prenatal care at Michigan Medicine\r\n\r\n               -  Mother has a linked patient profile to baby's profile\r\n\r\n               -  Baby has a length and weight measurement on record\r\n\r\n        Exclusion Criteria\r\n\r\n          -  Baby is a foster child\r\n\r\n          -  Baby was still in hospital 4 days after birth\r\n\r\n          -  Baby has severe perinatal or neonatal medical problems\r\n\r\n          -  Baby has severe developmental delays\r\n\r\n          -  Multiple births\r\n\r\n        For the Cross Sectional:\r\n\r\n        Inclusion Criteria\r\n\r\n          -  Enrolled in longitudinal arm of study\r\n\r\n          -  Baby and mother continue to receive primary care at Michigan Medicine, specifically:\r\n\r\n               -  Baby has had a recent well child check (4 month and / or 6 month)\r\n\r\n               -  Mother has a linked patient profile to baby's profile\r\n\r\n          -  Eligible to complete both protocols (Two Oatmeal and Reaching) as per protocol\r\n             screeners\r\n\r\n          -  Baby is alive\r\n\r\n          -  Baby is 5 to 7 months old at the time of enrollment\r\n\r\n          -  Mother is biological mother\r\n\r\n          -  Mother is legal guardian\r\n\r\n          -  Mother is English speaking\r\n\r\n        Exclusion Criteria\r\n\r\n          -  Baby had severe perinatal or neonatal medical problems\r\n\r\n          -  Baby currently has severe medical problems\r\n\r\n          -  Baby has severe developmental delays\r\n\r\n          -  Mom had severe complications during pregnancy\r\n\r\n          -  Multiple Births\r\n\r\n          -  Food allergies\r\n      ","sponsor":"University of Michigan","sponsor_type":"Other","conditions":"Eating Behavior","interventions":{},"outcomes":[{"outcome_type":"secondary","measure":"Association of infant reward-driven eating and infant diet","time_frame":"6 months through 24 months"},{"outcome_type":"secondary","measure":"Association of infant reward-driven eating and infant weight-for-length z-score (WLZ)","time_frame":"6 months through 24 months"},{"outcome_type":"secondary","measure":"Association of infant diet and infant weight-for-length z-score (WLZ)","time_frame":"6 months through 24 months"},{"outcome_type":"secondary","measure":"Association of infant reward-driven eating and weight-for-length z-score (WLZ)","time_frame":"2 months through 24 months"},{"outcome_type":"primary","measure":"Association of trajectory membership and body mass index z-score (BMIz)","time_frame":"24 months","description":"Trajectory membership could be \"wanting\", \"salience\", or \"liking\""},{"outcome_type":"secondary","measure":"Association of reward-driven eating component wanting with maternal and infant characteristics","time_frame":"2 months through 24 months"},{"outcome_type":"secondary","measure":"Association of reward-driven eating component salience with maternal and infant characteristics","time_frame":"2 months through 24 months"},{"outcome_type":"secondary","measure":"Association of reward-driven eating component liking with maternal and infant characteristics","time_frame":"2 months through 24 months"},{"outcome_type":"secondary","measure":"Association of maternal and infant characteristics and weight-for-length z-score (WLZ)","time_frame":"2 months through 24 months"}]}
{"nct_id":"NCT04608942","start_date":"2019-11-11","phase":"N/A","enrollment":25,"brief_title":"Refractory Meibomian Gland Dysfunction and Plasma Jet","official_title":"Plasma Jet Approach for Refractory Meibomian Gland Dysfunction Patients","primary_completion_date":"2020-08-07","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2022-08-31","last_update":"2020-10-30","description":"PURPOSE: The investigators propose a new treatment for refractory Meibomian Gland Dysfunction (MGD) patients with plasma jet to remove the hyperkeratinization layer from the lid margin to unblock terminal gland ducts and use thermal stimulation to enhance meibum delivery. METHODS: A prospective, interventional clinical safety and efficacy trial with 25 patients from the Department of Ophthalmology at Escola Paulista de Medicina (UNIFESP) to determine the efficacy and safety of the treatment of refractory MGD patients with plasma jet on both upper and lower lids. Patients will be submitted to an ophthalmology workup with best-corrected visual acuity (BCVA) (ETDRS chart) and dry eye questionnaires (DEQ-5 and OSDI). Bulbar redness, tear film meniscus height, noninvasive breakup time (NIKBUT), meibography under infrared light will be measured with Keratograph (Oculus). Following, tear film osmolarity (i-PenTM), meibomian gland expression, and Marx line assessment. All exams were performed at the baseline, 30 days, and 90 days after the plasma jet application.","other_id":"31031420.6.0000.5505","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Refractory meibomian gland dysfunction;\r\n\r\n          -  Previous eyelid hygiene with warm compress in the last 6 months;\r\n\r\n          -  Previous oral intake of antibiotics and antiinflammatories in the last 6 months;\r\n\r\n          -  Previous oral tetracycline treatment for at least one month in the last 6 months;\r\n\r\n          -  DEQ-5 score greater than 6;\r\n\r\n          -  OSDI score greater than 13;\r\n\r\n          -  Tear film osmolarity greater than 308mOsm or a difference between eyes greater than 8\r\n             mOsm;\r\n\r\n          -  Meibomian gland expression greater than 8;\r\n\r\n          -  Meibomian gland expression grades 2 or 3 [Nelson 1930];\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Cardiac pacemaker or ECG Holter;\r\n\r\n          -  Other electromagnetic device implanted;\r\n\r\n          -  Epilepsy;\r\n\r\n          -  Pregnancy;\r\n\r\n          -  Metal implants in the periocular area;\r\n\r\n          -  Skin diseases in the periocular area;\r\n\r\n          -  Systemic inflammatory diseases;\r\n\r\n          -  Oncological diseases;\r\n\r\n          -  Allergy to local anesthetics;\r\n      ","sponsor":"Federal University of So Paulo","sponsor_type":"Other","conditions":"Meibomian Gland Dysfunction|Dry Eye Disease|Evaporative Dry Eye|Inflammation|Tear Film Deficiency","interventions":[{"intervention_type":"Device","name":"Device: Jett Plasma Medical Lift","description":"Plasma Application versus Mechanical Debridement in refractory meibomian gland dysfunction"},{"intervention_type":"Procedure","name":"Procedure: Mechanical Debridement","description":"Plasma Application versus Mechanical Debridement in refractory meibomian gland dysfunction"}],"outcomes":[{"outcome_type":"primary","measure":"Dry Eye Questionnaire (DEQ-5)","time_frame":"30 days","description":"Dry Eye Questionnaire (DEQ-5) comprises of 5 quick questions and its score ranges from 0 to 22, with lower scores indicating a less severe disease (improvement)."},{"outcome_type":"primary","measure":"Ocular Surface Disease Index (OSDI)","time_frame":"30 days","description":"Ocular Surface Disease Index (OSDI) comprises of 12 questions, each one scored from 0 to 4, and the final score, on a scale from 0 to 100, result from the sum of all values divided by the number of questions answered. Lower scores indicate a less severe disease (improvement)."},{"outcome_type":"primary","measure":"Bulbar redness","time_frame":"30 days","description":"Conjunctival hyperemia will be measured with Keratograph (Oculus®, Inc). This software grades de hyperemia in both nasal and temporal bulbar regions and in the limbal area, with a final score indicating overall ocular surface redness. Greater scores indicate greater hyperemia."},{"outcome_type":"primary","measure":"Tear film meniscus height","time_frame":"30 days","description":"Tear film meniscus height will be measured with Keratograph (Oculus®, Inc). This software allows individual measurente of the tear film meniscus height (in milimeters) that will be performed in three regions (nasal, central and temporal tear meniscus) and the arithmetic average will be considered to evaluate treatment outcomes, with increased heights indicanting more tear volume."},{"outcome_type":"primary","measure":"Non-invasive tear breakup time (NITBUT)","time_frame":"30 days","description":"Non-invasive tear breakup time (NITBUT) will be assessed first with Keratograph (Oculus®, Inc). The NITBUT evaluate the tear film stability by registering the time lapse for the first rupture in the tear film to appear. Greater values indicates a more stable tear film."},{"outcome_type":"primary","measure":"Tear film osmolarity","time_frame":"30 days","description":"Tear film osmolarity will be measured by collecting a micro drop from the tear meniscus with i-Pen (i-Med Pharma, Inc). The tear osmolarity is used to indirect assess occular surface inflammation, with tear osmolalities greater than 308 mOsm or a difference between eyes greater than 8 mOsm indicating tear film disturbance (Dry Eye WorkShop II - DEWS II 2017)."},{"outcome_type":"primary","measure":"Meibomian gland expression","time_frame":"30 days","description":"Meibomian gland expression will be performed using Meibomian Gland Evaluator (MGE), a special devide with precise pression, that will allow to assess meibomian glands in the slit lamp. This devices acts on five glands at a time, so meibum deliverance can be judged in quantity (is there any gland duct obstructed?) and quality (is meibum clear, cloudy or opaque?)."},{"outcome_type":"secondary","measure":"Dry Eye Questionnaire (DEQ-5)","time_frame":"90 days","description":"Dry Eye Questionnaire (DEQ-5) comprises of 5 quick questions and its score ranges from 0 to 22, with lower scores indicating a less severe disease (improvement)."},{"outcome_type":"secondary","measure":"Ocular Surface Disease Index (OSDI)","time_frame":"90 days","description":"Ocular Surface Disease Index (OSDI) comprises of 12 questions, each one scored from 0 to 4, and the final score, on a scale from 0 to 100, result from the sum of all values divided by the number of questions answered. Lower scores indicate a less severe disease (improvement)."},{"outcome_type":"secondary","measure":"Bulbar redness","time_frame":"90 days","description":"Conjunctival hyperemia will be measured with Keratograph (Oculus®, Inc). This software grades de hyperemia in both nasal and temporal bulbar regions and in the limbal area, with a final score indicating overall ocular surface redness. Greater scores indicate greater hyperemia."},{"outcome_type":"secondary","measure":"Tear film meniscus height","time_frame":"90 days","description":"Tear film meniscus height will be measured with Keratograph (Oculus®, Inc). This software allows individual measurente of the tear film meniscus height (in milimeters) that will be performed in three regions (nasal, central and temporal tear meniscus) and the arithmetic average will be considered to evaluate treatment outcomes, with increased heights indicanting more tear volume."},{"outcome_type":"secondary","measure":"Non-invasive tear breakup time (NITBUT)","time_frame":"90 days","description":"Non-invasive tear breakup time (NITBUT) will be assessed first with Keratograph (Oculus®, Inc) and then with florescein dye. The NITBUT evaluate the tear film stability by registering the time lapse for the first rupture in the tear film to appear. Greater values indicates a more stable tear film."},{"outcome_type":"secondary","measure":"Tear film osmolarity","time_frame":"90 days","description":"Tear film osmolarity will be measured by collecting a micro drop from the tear meniscus with i-Pen (i-Med Pharma, Inc). The tear osmolarity is used to indirect assess occular surface inflammation, with tear osmolalities greater than 308 mOsm or a difference between eyes greater than 8 mOsm indicating tear film disturbance (Dry Eye WorkShop II - DEWS II 2017)."},{"outcome_type":"secondary","measure":"Meibomian gland expression","time_frame":"90 days","description":"Meibomian gland expression will be performed using Meibomian Gland Evaluator (MGE), a special devide with precise pression, that will allow to assess meibomian glands in the slit lamp. This devices acts on five glands at a time, so meibum deliverance can be judged in quantity (is there any gland duct obstructed?) and quality (is meibum clear, cloudy or opaque?)."}]}
{"nct_id":"NCT04146506","start_date":"2019-11-11","enrollment":72,"brief_title":"Gender Differences in the Tolerance to Stretch","official_title":"The Effect of Stretching on Pain Sensitivity - Potential Gender Differences?","primary_completion_date":"2020-03-30","study_type":"Observational","rec_status":"Completed","completion_date":"2020-07-30","last_update":"2020-10-06","description":"The effect of stretching on range of motion is believed to rely upon an increased tolerance to stretch. This suggests, that pain modulation has significance in regards to the effect of stretching.","other_id":"UniversityCND2","observational_model":"Case-Control","time_perspective":"Cross-Sectional","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":45,"population":"Healthy male and female volunteers between the ages of 18 to 45 are eligible for\r\n        participation.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Absence of any pain or other conditions which might affect the somatosensory system\r\n             and pain perception\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Substance abuse, History of neurological or mental disabilities, Lack of ability to\r\n             comply with instructions, Delayed onset of muscle soreness\r\n      ","sponsor":"University College of Northern Denmark","sponsor_type":"Other","conditions":"Range of Motion, Articular|Muscle Stretching Exercises","interventions":[{"intervention_type":"Other","name":"Other: Muscle stretching exercises","description":"Muscle stretching exercises consisting of static stretching exercises of the knee flexors"}],"outcomes":[{"outcome_type":"primary","measure":"Range of Motion","time_frame":"Passive knee extension range of motion was measured at baseline just prior to Muscle stretching exercises","description":"Passive knee extension Range of motion"},{"outcome_type":"primary","measure":"Range of Motion","time_frame":"Passive knee extension range of motion was measured 30 seconds after Muscle stretching exercises","description":"Passive knee extension Range of motion"},{"outcome_type":"primary","measure":"Pain Thresholds","time_frame":"Pressure pain Thresholds were measured at baseline just prior to muscle stretching exercises","description":"Pressure Pain Thresholds"},{"outcome_type":"primary","measure":"Pain Thresholds","time_frame":"Pressure pain Thresholds were measured 30 seconds after muscle stretching exercises","description":"Pressure Pain Thresholds"},{"outcome_type":"primary","measure":"Torque","time_frame":"Passive resistive torque was measured at baseline just prior to muscle stretching exercises","description":"Passive Resistive Torque"},{"outcome_type":"primary","measure":"Torque","time_frame":"Passive resistive torque was measured 30 seconds after muscle stretching exercises","description":"Passive Resistive Torque"}]}
{"nct_id":"NCT04327947","start_date":"2019-11-06","phase":"N/A","enrollment":65,"brief_title":"Evaluation of Gynecological Acceptability of 3 Health Care Products","official_title":"Evaluation of Gynecological Acceptability of 3 Health Care Products (Intimate Gel)","primary_completion_date":"2019-12-10","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-02-21","last_update":"2020-04-03","description":"The research was conduct with 3 different products for use in the intimate region in up to 70 research participants, that use the investigational product by 35  2 days. The subjects were follow up throughout the study by a gynecologist for verification of safety, effectiveness and possible adverse events.","other_id":"All-S-EP-076888","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","intervention_model_description":"Clinical trial, triple arm, randomized","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Health volunteers\r\n\r\n          -  Non-injured mucosa in the test region;\r\n\r\n          -  Agreement to adhere to study procedures and requirements and attend the institute on\r\n             the day(s) and time(s) determined for the evaluations;\r\n\r\n          -  Ability to consent to their participation in the study;\r\n\r\n          -  Age from 18 to 70 years old;\r\n\r\n          -  Female participants;\r\n\r\n          -  Vaginal dryness (slight minimum) - according to questions from the gynecologist.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnancy or breastfeeding;\r\n\r\n          -  Skin pathology in the area of application of the product;\r\n\r\n          -  Diabetes Mellitus type 1; insulin-dependent diabetes; presence of complications due to\r\n             diabetes (retinopathy, nephropathy, neuropathy); presence of diabetes-related\r\n             dermatoses (plantar ulcer, lipoid necrobiosis, annular granuloma, opportunistic\r\n             infections); history of episodes of hypoglycemia, diabetic ketoacidosis and/or\r\n             hyperosmolar coma;\r\n\r\n          -  Current use of the following medications for topical or systemic use:\r\n\r\n        corticosteroids, immunosuppressants and antihistamines;\r\n\r\n          -  Skin diseases: vitiligo, psoriasis, lupus, atopic dermatitis;\r\n\r\n          -  History of reaction to the category of the tested product;\r\n\r\n          -  Other diseases or medications that may directly interfere with the study or endanger\r\n             the health of the research participant.\r\n      ","sponsor":"Herbarium Laboratorio Botanico Ltda","sponsor_type":"Industry","conditions":"Atrophic Vaginitis|Vaginal Disease","interventions":[{"intervention_type":"Other","name":"Other: Hyaluronic acid - Research product 1","description":"Health care product (intimate gel)"},{"intervention_type":"Other","name":"Other: Hyaluronic acid - Research product 2","description":"Health care product (intimate gel)"},{"intervention_type":"Other","name":"Other: Hyaluronic acid - Comparator product","description":"Health care product (intimate gel)"}],"outcomes":[{"outcome_type":"primary","measure":"Perceived hydration","time_frame":"9 days","description":"Evaluate the perceived hydration, through a subjective questionnaire based on \"Standard Guide for Sensory Claim Substantiation\""}]}
{"nct_id":"NCT04769804","start_date":"2019-11-01","enrollment":200,"brief_title":"Gene Polymorphism in Tinea Versicolor","official_title":"Detection of IL1-7A and IL-17F Gene Polymorphism in Pityriasis Versicolor and Its Relation to Susceptibility to Infections.","primary_completion_date":"2021-06-01","study_type":"Observational","rec_status":"Recruiting","completion_date":"2021-11-01","last_update":"2021-04-26","description":"Blood samples will be taken from cases presenting with recurrent tinea versicolor , after confirmation of diagnosis by wood's light and KOH examination, for the detection of gene polymorphism in IL17 A and IL17 F. In addition , serum samples from patients and controls will be tested for 25(OH)2 D3","other_id":"PolymorphismTV","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":60,"population":"Patients with history of disseminated TV, with 2 or more episodes of TV per year.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  - Patients with recurrent pityriasis versicolor (active now) and not taking treatment\r\n             for it.\r\n\r\n          -  Patients of both genders.\r\n\r\n          -  Age 18 years old.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  - Patients with other cutaneous diseases.\r\n\r\n          -  Patient's having dandruff (scaly scalp) even if not symptomatizing.\r\n\r\n          -  Pregnant and lactating females, children, prisoners, cognitively impaired or mentally\r\n             disabled subjects.\r\n\r\n          -  Patients with autoimmune diseases.\r\n\r\n          -  Patients with immunodeficiency diseases.\r\n\r\n          -  Immunosuppressed patients e.g. HIV, diabetics, organ transplant, malignancy, patients\r\n             taking immunosuppressive drugs e.g. chemotherapy, cortisone.\r\n      ","sponsor":"Kasr El Aini Hospital","sponsor_type":"Other","conditions":"Recurrent Pityriasis Versicolor","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"IL 17A gene polymorphism","time_frame":"6months-1 year","description":"IL 17A"},{"outcome_type":"primary","measure":"IL 17 F gene polymorphism","time_frame":"6months-1 year","description":"IL 17 F"},{"outcome_type":"secondary","measure":"Vitamin D","time_frame":"6months-1 year","description":"Serum 25(OH)2 D3"}]}
{"nct_id":"NCT03931655","start_date":"2019-11-01","phase":"N/A","enrollment":20,"brief_title":"Photoacoustic Lymph Node Imaging","official_title":"A Preliminary Study of Photoacoustic Imaging to Detect Micrometastases in the Lymph Nodes of Breast Cancer Patients","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Enrolling by invitation","completion_date":"2021-12-31","last_update":"2021-04-29","description":"In this spectroscopic photoacoustic imaging study, the investigators will acquire images (only) to: 1. determine if spectroscopic photoacoustic imaging can acquire high fidelity images in a clinical setting, 2. discover if blood oxygen saturation changes are observable in breast cancer patients during early stages of metastatic invasion, and 3. compare the sensitivity and specificity of photoacoustic imaging with ultrasound imaging for the detection of lymph node metastases. The results from imaging will not be used in any decision making process. This study is solely used to test the photoacoustic imaging device and evaluate it against the current standard of care. The device is completely noninvasive and uses only safe levels of energy as determined by the American National Standards Institute (ANSI) and the FDA. The device does not pose a serious to the health, safety, or welfare of the patient.","other_id":"D18155","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Subjects are female age 18 or older with a detected breast lesion.\r\n\r\n          2. Subjects have suspected lymph node involvement as determined by MRI.\r\n\r\n          3. Subjects are scheduled for an ultrasound exam of the suspected node(s).\r\n\r\n          4. Subjects are capable of giving informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Subjects who have had prior surgery in or near the axillary lymph nodes.\r\n\r\n          2. Subjects currently undergoing chemotherapy, radiation therapy, hormone therapy, or\r\n             targeted therapy for the breast cancer.\r\n\r\n          3. Subjects who will be receiving neoadjuvant therapy prior to the sentinel lymph node\r\n             biopsy.\r\n\r\n          4. Subjects who are homeless persons or have active drug/alcohol dependence or abuse\r\n             history.\r\n\r\n          5. Subjects who are pregnant or breast-feeding.\r\n      ","sponsor":"Geoff Luke","sponsor_type":"Other","conditions":"Breast Cancer","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Spectroscopic photoacoustic imaging","description":"Spectroscopic photoacoustic imaging uses a laser that is pulsed for a nanosecond, applying laser light to the patient's skin. Hemoglobin and melanin absorb the laser's energy and convert it to heat, which rapidly expands local tissue and produces a broadband ultrasound wave and is detected with a clinical ultrasound transducer. Because the signal is proportional to the optical absorption in tissue, high resolution images of the lymph nodes can be acquired from the detected ultrasound waves, and can be used to measure saturated oxygen in the nodes."}],"outcomes":[{"outcome_type":"primary","measure":"Spectroscopic photoacoustic image acquisition feasibility","time_frame":"Through study completion, an average of 12 weeks","description":"Determine the feasibility of using spectroscopic photoacoustic imaging to determine the metastatic state of lymph nodes prior to surgery/biopsy by measuring changes in blood oxygen saturation."},{"outcome_type":"secondary","measure":"Spectroscopic photoacoustic image depth","time_frame":"Day 1, up to 12 weeks after imaging","description":"Determine the maximum imaging depth that can be reliably achieved with spectroscopic photoacoustic imaging."},{"outcome_type":"secondary","measure":"Spectroscopic photoacoustic imaging device comparison","time_frame":"Day 1, up to 12 weeks after imaging","description":"Determine the variance of saturated oxygen measurements acquired with spectroscopic photoacoustic imaging."}]}
{"nct_id":"NCT03894137","start_date":"2019-10-31","phase":"N/A","enrollment":15,"brief_title":"The Acute Effect of Grains of Paradise (Aframomum Melegueta) on REE","official_title":"The Acute Effect of Grains of Paradise (Aframomum Melegueta) on Resting Energy Expenditure in Lean, Healthy, Adults","primary_completion_date":"2020-03-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2020-05-31","last_update":"2019-03-28","description":"Grains of paradise (Aframomumu melegueta) (GP), also known as Guinea pepper or Alligator pepper, belongs to the Zingiberaceae family, which is native to West Africa. GP seeds are used as a spice and also have wide-ranging ethnobotanical uses. GP seeds are very rich in non-volatile pungent compounds such as 6-paradol, 6-gingerol, 6-shogaol and related compounds. This feature may equip them with the power to activate the Sympathetic Nervous System and thereby increase EE, which has been demonstrated in rodents. Research suggest that ingestion of GP extract can result in sustained elevation of EE and a consequent reduction in body fat. Thus, there is some evidence that GP may have a potential thermogenic effect that could be useful as part of a weight loss treatment. However, there is no information on whether GP has the potential of improving and prolonging the thermogenic effects of bioactives known to elevate fatty acid mobilization and subsequent fat oxidation. This proposal will fill a void in the literature by testing for the first time in healthy, normal weight, human volunteers whether the ingestion of GP in combination with a commercially available complex containing caffeine, green tea, and forskolin has an enhanced acute effect on REE, the largest and most stable component of EE, as well as the ratio of fat:carbohydrate oxidation. This project will provide pilot data to support larger studies such as prospective studies and studies to compare the thermogenic effect with currently available compounds.","other_id":"1355504-1","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Prevention","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Ages 18-65 years\r\n\r\n          -  Men and women\r\n\r\n          -  Able to provide written consent in English\r\n\r\n          -  A body mass index between 18.5 and 30 kg/m2\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Current smoker\r\n\r\n          -  Claustrophobia\r\n\r\n          -  Use of any prescribed or over-the-counter medication affecting metabolism\r\n\r\n          -  Suffering from cardiac, hepatic, renal, pulmonary, endocrine or hematological disease\r\n\r\n          -  Currently pregnant or breastfeeding\r\n\r\n          -  Consuming more than 300mg of caffeine per day\r\n\r\n          -  Consuming more than 2 alcoholic beverages per day.\r\n\r\n          -  Performing more than 3 hrs/week of strenuous exercise\r\n\r\n          -  Weight loss of more than 5% of body weight over the past 6 months\r\n\r\n          -  Not willing to abstain from alcohol, caffeine and exercise for 24hr before each test\r\n             day.\r\n\r\n          -  Suffering from heartburn or a sensitivity to pungent compounds in foods\r\n      ","sponsor":"Plexus Worldwide","sponsor_type":"Industry","conditions":"Obesity","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Grains of Paradise (Aframomum Melegueta)","description":"This is a randomized, double blind, crossover design testing the effect of grains of paradise on resting energy metabolism"}],"outcomes":[{"outcome_type":"primary","measure":"Resting metabolic Rate (Liters of oxygen consumed per minute)","time_frame":"3 weeks","description":"Metabolic cart (metabolic gas exchange, indirect calorimitry)"},{"outcome_type":"secondary","measure":"Resting substrate oxidation","time_frame":"3 weeks","description":"Metabolic cart (respiratory exchange ratio)"},{"outcome_type":"other","measure":"Heart Rate (beats per minute)","time_frame":"3 weeks","description":"pulse frequency over time"},{"outcome_type":"other","measure":"Blood Pressure (mmHg)","time_frame":"3 weeks","description":"automatic blood pressure cuff"}]}
{"nct_id":"NCT03813017","start_date":"2019-10-31","enrollment":100,"brief_title":"Comprehensive Assessment of Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis","official_title":"Comprehensive Assessment of Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis","primary_completion_date":"2020-03-31","study_type":"Observational [Patient Registry]","rec_status":"Unknown status","completion_date":"2020-07-31","last_update":"2019-07-10","description":"Cardiovascular disease is a leading cause for morbidity and mortality in general population. The incidence of cardiovascular disease and their poor outcome is well documented in a broad spectrum of connective tissue diseases, especially in rheumatoid arthritis (RA). The risk of incident CVD is increased by 48% in patients with RA compared to the general population. RA is associated with 50% increase in the mortality in patients with cardiovascular disease (CVD). One reason is the more frequent cardiovascular risk factors in RA patients compared with the general population. Patients with RA have a high risk of premature cardiovascular disease (CVD). The aim of the present study is to assess whether there are non-invasive measures that might predict arteriosclerosis in RA patients.","other_id":"0123-18-ZIV","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":70,"population":"This study will be conducted in Ziv Medical Center, Safed, Internal Medicine Department A,\r\n        on 100 patients with rheumatoid artheritis","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. 18-70 years old (except for women till 75 years old)\r\n\r\n          2. Absence of established CVD:\r\n\r\n               -  Myocardial Infarction p/h\r\n\r\n               -  PCI with balloon and/or stent\r\n\r\n               -  Intermittent claudication\r\n\r\n               -  PAD / intervention\r\n\r\n               -  CAS /intervention\r\n\r\n          3. Signed informed consent form\r\n\r\n          4. Documented diagnosis of rheumatoid arthritis\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Known CVD\r\n\r\n          2. Pregnancy\r\n      ","sponsor":"Ziv Hospital","sponsor_type":"Other","conditions":"Cardiovascular Diseases|Rheumatoid Arthritis|Atherosclerosis, Coronary","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Cardiovascular disease risks in patient with theumatoid arthritis","time_frame":"6 months","description":"Prediction of cardiovascular risks and proposed preventive treatment"}]}
{"nct_id":"NCT04049539","start_date":"2019-10-31","phase":"Phase 2","enrollment":37,"brief_title":"Vyxeos for Re-induction Treatment of Acute Myeloid Leukemia Patients With Persistent Disease After Induction","official_title":"Open-Label Phase 2 Trial of Vyxeos in Patients With Intermediate and High-Risk Acute Myeloid Leukemia Who Have Failed an Initial Cycle of Standard Cytarabine and Daunorubicin Chemotherapy","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2021-12-31","last_update":"2019-08-08","description":"This phase II trial studies the side effects and how well Vyxeos works in treating patients with intermediate and high-risk acute myeloid leukemia who have failed an initial cycle of standard cytarabine and daunorubicin chemotherapy. Vyxeos is a combination of both chemotherapy drugs cytarabine and daunorubicin contained in a liposome. Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cytarabine and daunorubicin given together in liposomes may have fewer side effects and work better than cytarabine and daunorubicin given alone in patients with acute myeloid leukemia.","other_id":"OSU-19060","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subject or their legal guardian must be able to provide written informed consent\r\n\r\n          -  Patients must have a diagnosis of acute myeloid leukemia\r\n\r\n          -  Patients must have received standard continuous infusion cytarabine and daunorubicin\r\n             (cytarabine 100-200 mg/m^2 by continuous infusion on days 1-7 and daunorubicin 45-90\r\n             mg/m^2 on days 1-3) within the 14-26 days prior to starting trial treatment and have\r\n             documented persistent disease (13-22 days from the start of 7+3 treatment). Patients\r\n             who have received a 7+3 regimen utilizing idarubicin (12 mg/m^2 on days 1-3) in place\r\n             of daunorubicin may enroll. Persistent disease will be defined as bone marrow\r\n             cellularity of > 10-20% and bone marrow blast percentage of > 5-10% or clear evidence\r\n             of immunophenotypically aberrant leukemia cells in the bone marrow. The final\r\n             determination of persistent AML will be made by the treating physician, but must meet\r\n             National Comprehensive Cancer Network (NCCN) criteria for persistent disease.\r\n             Enrollment of patients with less than 20% cellularity or less than 10% blasts will\r\n             require approval of the principal investigator. Patients who received concomitant\r\n             treatment with another targeted therapy for AML (e.g. midostaurin) during initial\r\n             induction may enroll, but will not continue to receive this treatment during Vyxeos\r\n             treatment\r\n\r\n          -  Patients must be deemed by the treating physician to be unlikely to achieve complete\r\n             response (CR) without further therapy\r\n\r\n          -  Patients must be deemed by the treating physician to be able to tolerate intensive\r\n             chemotherapy (similar to 7+3 chemotherapy)\r\n\r\n          -  Normal left ventricular ejection fraction (>= 50% by echocardiography or multi-gated\r\n             acquisition radionuclide angiocardiography [MUGA]) and lifetime daunorubicin dose of\r\n             less than 418 mg/m^2 (including recent course of 7+3)\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) functional status of 0, 1, or 2\r\n\r\n          -  Aspartate aminotransferase (AST) < 5 x upper limit of normal (ULN) for the local\r\n             laboratory\r\n\r\n          -  Alanine aminotransferase (ALT) < 5 x ULN for the local laboratory\r\n\r\n          -  Total bilirubin < 1.5 x ULN (except for patients with known Gilbert?s syndrome) for\r\n             the local laboratory\r\n\r\n          -  Calculated creatinine clearance (according to the Cockcroft-Gault equation) > 40\r\n             mL/min OR serum creatinine < 1.5 x the ULN for the local laboratory\r\n\r\n          -  Female patients of childbearing potential must agree to use two forms of contraception\r\n             from screening visit until 6 months following the last dose of study treatment. Female\r\n             patients must have a documented negative pregnancy test\r\n\r\n          -  Male patients of childbearing potential having intercourse with females of\r\n             childbearing potential must agree to abstain from heterosexual intercourse or have\r\n             their partner use two forms of contraception from screening visit until 90 days until\r\n             the last dose of study treatment. They must also refrain from sperm donation from\r\n             screening visit until 90 days following the last dose of study treatment\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Acute promyelocytic leukemia (or M3 AML)\r\n\r\n          -  Patients known to have core binding factor AML (defined as presence of t(8;21),\r\n             inv(16), or other cytogenetically equivalent abnormalities)\r\n\r\n          -  Patients known to have inactivating mutations of TP53 or evidence of an absence of p53\r\n             protein activity as indicated by a monosomal karyotype. Monosomal karyotype will be\r\n             defined as two or more monosomies (loss of an entire chromosome or the entire long arm\r\n             of a chromosome [such as 7q-]) or a single monosomy in the setting of a complex\r\n             karyotype. Patients with a complex karyotype without a monosomy are eligible to enroll\r\n\r\n          -  Patients that the treating physician does not feel are able to tolerate intensive\r\n             chemotherapy\r\n\r\n          -  History of serious (>= grade 3) hypersensitivity reaction to cytarabine, daunorubicin,\r\n             or any component of the formulation\r\n\r\n          -  Known Wilson's disease or other symptomatic abnormality of copper metabolism\r\n             (laboratory screening is not required in the absence of clinical or historical\r\n             evidence of Wilson's disease or other problems of copper metabolism)\r\n\r\n          -  Total lifetime daunorubicin dose of more than 418 mg/m^2 (including recent course of\r\n             7+3) or equivalent total doses of other anthracycline medications\r\n\r\n          -  Pregnancy or inability to use highly effective method of contraception for 6 months\r\n             following last dose of Vyxeos. Potentially fertile patients must have documented\r\n             negative serum pregnancy test. Breastfeeding should be avoided for at least 14 days\r\n             after the last dose Vyxeos\r\n\r\n          -  Patients with uncontrolled infection shall not be enrolled until infection is treated\r\n             and brought under control. As infection is a common feature of AML, patients with\r\n             active infections are permitted to enroll provided that the infection is under control\r\n\r\n          -  Patients who have received an investigational agent (for any indication) within 5\r\n             half-lives of the agent and until toxicity from this has resolved to grade 1 or less;\r\n             if the half-life of the agent is unknown, patients must wait 4 weeks prior to first\r\n             dose of study treatment. An investigational agent is one for which there is no\r\n             approved indication by the United States (US) Food and Drug Administration (FDA)\r\n\r\n          -  Patients with psychological, familial, social, or geographic factors that otherwise\r\n             preclude them from giving informed consent, following the protocol, or potentially\r\n             hamper compliance with study treatment and follow-up\r\n\r\n          -  Any other significant medical condition, including psychiatric illness or laboratory\r\n             abnormality, that would preclude the patient participating in the trial or would\r\n             confound the interpretation of the results of the trial\r\n\r\n          -  Patients with the following will be excluded: uncontrolled intercurrent illness\r\n             including, but not limited to, symptomatic congestive heart failure, unstable angina\r\n             pectoris, serious cardiac arrhythmia, myocardial infarction within 6 months prior to\r\n             enrollment, New York Heart Association (NYHA) class III or IV heart failure, severe\r\n             uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute\r\n             ischemia or active conduction system abnormalities\r\n\r\n          -  Other malignancy currently requiring active therapy (except minor surgery for\r\n             non-melanoma skin cancer and for hormonal/anti-hormonal treatment, e.g. in prostate or\r\n             breast cancer)\r\n      ","sponsor":"Ohio State University Comprehensive Cancer Center","sponsor_type":"Other","conditions":"Blasts More Than 5 Percent of Bone Marrow Nucleated Cells|Persistent Disease|Refractory Acute Myeloid Leukemia","interventions":[{"intervention_type":"Drug","name":"Drug: Liposome-encapsulated Daunorubicin-Cytarabine","description":"Given IV"}],"outcomes":[{"outcome_type":"other","measure":"Number of patients proceeding to stem cell transplantation following Vyxeos treatment","time_frame":"Up to 2 years","description":"Will be measured and is exploratory in nature. It will be analyzed with descriptive statistics to gather preliminary information and compared to historical controls."},{"outcome_type":"primary","measure":"Incidence of adverse events","time_frame":"Up to 60 days","description":"Will be measured by the time to count recovery, incidence of symptomatic cardiac dysfunction, incidence of hepatic or renal toxicity, incidence of severe hemorrhage, and incidence of severe infection. Will be summarized by National Cancer Institute Common Terminology Criteria for Adverse Events version 4, and frequency counts will be tabulated with a focus on severe (grade 3+) adverse events and toxicities that are deemed at least possibly related to study treatment. The incidence of specific toxicities will be calculated as the proportion of patients experience these toxicities over all patients who receive any study drug."},{"outcome_type":"primary","measure":"Calculation rate of complete response (CR) and complete response with incomplete hematologic recovery (CRi)","time_frame":"Up to 2 years","description":"CR and CRi rate will be defined as the proportion of patients who achieve CR or CRi over all evaluable patients. The rates will be provided with 95% binomial confidence intervals."},{"outcome_type":"secondary","measure":"Progression-free survival","time_frame":"Up to 2 years","description":"Will be calculated by the method of Kaplan-Meier, with the 2-year estimate provided with 95% confidence interval."},{"outcome_type":"secondary","measure":"Overall survival","time_frame":"From the date of the first dose of study treatment to death from any cause, up to 2 years","description":"Will be calculated by the method of Kaplan-Meier, with the 2-year estimate provided with 95% confidence interval."},{"outcome_type":"other","measure":"Measurement of blast cell cycle fraction","time_frame":"Baseline up to day 42","description":"Will be exploratory in nature with graphical methods and descriptive statistics provided to gather preliminary information. Nonparametric method such Mann-Whitney U test will be utilized to compare pre and post-treatment data, and box plot or spaghetti plot will be presented to help visualize the trend of change."},{"outcome_type":"other","measure":"Relative clearance immunophenotypically abnormal blast and stem cells","time_frame":"Up to day 42","description":"Will be exploratory in nature with graphical methods and descriptive statistics provided to gather preliminary information. Nonparametric method such Mann-Whitney U test will be utilized to compare pre and post-treatment data, and box plot or spaghetti plot will be presented to help visualize the trend of change."},{"outcome_type":"other","measure":"Efficacy of blast cell and leukemia stem/repopulating cell (LSC) elimination","time_frame":"Up to day 42","description":"Will compare the efficacy of blast cell and LSC elimination in patients receiving Vyxeos re-induction compared to similar blast cells and LSCs in patients receiving standard 7+3 or 5+2 re-induction. Will be exploratory in nature with graphical methods and descriptive statistics provided to gather preliminary information. Nonparametric method such Mann-Whitney U test will be utilized to compare pre and post-treatment data, and box plot or spaghetti plot will be presented to help visualize the trend of change."}]}
{"nct_id":"NCT03865082","start_date":"2019-10-29","phase":"Phase 2","enrollment":30,"brief_title":"Study of Tilsotolimod in Combination With Nivolumab and Ipilimumab for the Treatment of Solid Tumors (ILLUMINATE-206)","official_title":"Study of Tilsotolimod in Combination With Nivolumab and Ipilimumab for the Treatment of Solid Tumors","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-04-30","last_update":"2021-07-21","description":"A Phase 2 study intended to see efficacy of tilsotolimod in combination with immunotherapy drugs ipilimumab and nivolumab in different solid tumors.","other_id":"2125-MST-206","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Main Inclusion Criteria:\r\n\r\n          1. Subject must be willing and able to sign the informed consent and comply with study\r\n             protocol.\r\n\r\n          2. Must be  18 years of age (males and females).\r\n\r\n          3.  1 lesion accessible for i.t. injection and biopsy(ies).\r\n\r\n          4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 minimum life\r\n             expectancy  4 months.\r\n\r\n          5. Adequate baseline organ function as defined by:\r\n\r\n               1. Absolute neutrophil count (ANC)  1.5 x 109/L (1500/mm3)\r\n\r\n               2. Platelet count  100 x 109/L (100,000/mm3)\r\n\r\n               3. Hemoglobin  9.0 g/dL (5.59 mmol/L)\r\n\r\n               4. Serum creatinine  1.5 x upper limit of normal (ULN) or calculated creatinine\r\n                  clearance of  40 mL/minute (measured or calculated using the Cockroft-Gault\r\n                  formula)\r\n\r\n               5. Aspartate aminotransferase (AST)  3 x ULN, alanine aminotransferase (ALT)  3 x\r\n                  ULN; AST/ALT < 5 ULN if liver involvement\r\n\r\n               6.  1.5 x ULN, except in subjects with Gilbert's syndrome who must have a total\r\n                  bilirubin  3 mg/dL\r\n\r\n          6. Women of child bearing potential (WOCBP) and men with WOCBP partners must agree to use\r\n             effective contraception methods as defined in the clinical study protocol.\r\n\r\n          7. For any subjects who received prior approved/investigational i.t. anti-cancer\r\n             treatments, the study's Medical Monitor must be consulted before enrollment.\r\n\r\n        Inclusion Criteria ( MSS CRC IO Nave)\r\n\r\n          1. Histologically confirmed advanced, metastatic, or progressive MSS CRC based on either\r\n             an analysis of tissue from a prior biopsy or based on tissue from a new biopsy.\r\n             Subject's microsatellite/MMR status should be known.\r\n\r\n          2. Received two prior lines of therapy for advanced or metastatic CRC including\r\n             fluoropyrimidine-, oxaliplatin-, and irinotecan-based regimens. Subjects who relapse\r\n             within 6 months of adjuvant chemotherapy composed of oxaliplatin and a\r\n             fluoropyrimidine will have their adjuvant therapy count as one prior regimen.\r\n\r\n          3. Documentation of radiologic progression by Response Evaluation Criteria in Solid\r\n             Tumors (RECIST) v1.1 during or after previous chemotherapy. Subjects documented\r\n             clinical progression may be eligible and must be discussed with the medical monitor to\r\n             determine eligibility.\r\n\r\n        Main Exclusion Criteria:\r\n\r\n          1. Subject must have completed or completely discontinued any previous cancer-related\r\n             treatments before enrollment with necessary windows and wash out periods as defined in\r\n             the clinical study protocol.\r\n\r\n          2. History of interstitial lung disease, pneumonitis, known or suspected autoimmune\r\n             diseases (unless for specific diseases as defined in protocol) or human\r\n             immunodeficiency virus (HIV) infection.\r\n\r\n          3. Prior therapy with TLR9 agonist, excluding topical agents.\r\n\r\n          4. Known hypersensitivity to any study drug component.\r\n\r\n          5. Treatment with botanical preparations (e.g. herbal supplements or traditional Chinese\r\n             medicines) intended for general health support or to treat the disease under study\r\n             within 2 weeks prior to treatment.\r\n\r\n          6. Known or suspected autoimmune diseases. Subjects with type I diabetes mellitus,\r\n             hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo,\r\n             psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected\r\n             to recur in the absence of an external trigger are permitted to be enrolled.\r\n\r\n             Subject with a requirement of systemic steroids > 10 mg/day of prednisone (or\r\n             equivalent) for the 2 weeks preceding start of study treatment.\r\n\r\n          7. Subject with another primary malignancy that has not been in remission for at least 3\r\n             years except for non-melanoma skin cancer, curatively treated localized prostate\r\n             cancer with non-detectable prostate specific antigen, cervical carcinoma in situ on\r\n             biopsy, or thyroid cancer (except anaplastic).\r\n\r\n          8. Active systemic infections requiring antibiotics.\r\n\r\n          9. Active Hepatitis A, B or C infections.\r\n\r\n         10. Known diagnosis of human immunodeficiency virus (HIV) infection or known acquired\r\n             immunodeficiency syndrome (AIDS). NOTE: Testing for HIV must be performed at sites\r\n             where mandated locally.\r\n\r\n         11. Women who are breast feeding or pregnant.\r\n\r\n         12. Prior anaphylactic or other severe infusion reaction associated with human antibody\r\n             administration that cannot be managed by standard supportive measurements.\r\n\r\n         13. Presence of known central nervous system (CNS), meningeal, or epidural metastatic\r\n             disease.However, subjects with known brain metastases are allowed if brain metastases\r\n             are stable for 4 weeks before the first dose of study treatment. Stable is defined as\r\n             neurological symptoms not present or resolved at baseline, no radiological evidence of\r\n             progression, and steroid requirement of prednisone  10 mg/day or equivalent.\r\n\r\n         14. Subject with unstable and impaired cardiac function or clinically significant cardiac\r\n             disease per Investigator's clinical judgment.\r\n\r\n         15. Has received live attenuated vaccine 30 days before first study dose. Any live\r\n             attenuated vaccine [e.g., varicella, zoster, yellow fever, rotavirus, oral polio and\r\n             measles, mumps, rubella (MMR)] during treatment and until 100 days post last dose will\r\n             be prohibited.\r\n\r\n        Exclusion Criteria (MSS CRC IO Nave):\r\n\r\n          1. Prior therapy with an anti-programmed cell death-1 (PD-1), anti-programmed cell death\r\n             ligand-1 (PD-L1), or anti-PD-L2 agent or with an agent directed to another stimulatory\r\n             or co-inhibitory T-cell receptor in an approved or experimental setting.\r\n\r\n          2. Subjects with BRAF V600E mutations.\r\n\r\n          3. Subjects with a history of immune-mediated colitis.\r\n\r\n          4. Subjects who received three or more lines of therapy for advanced or metastatic CRC\r\n      ","sponsor":"Idera Pharmaceuticals, Inc.","sponsor_type":"Industry","conditions":"Solid Tumor","interventions":[{"intervention_type":"Drug","name":"Drug: Tilsotolimod","description":"9 doses of Tilsotolimod Intratumoral injection administered as a dose of 8mg at Week 0 Day 1 (7 days prior to the start of Cycle 1), Day 1 and Day 8 of Cycle 1, and on Day 1 of Cycles 2 through 7."},{"intervention_type":"Drug","name":"Drug: Nivolumab","description":"Specified dose on specified days."},{"intervention_type":"Drug","name":"Drug: Ipilimumab","description":"Specified dose on specified days."}],"outcomes":[{"outcome_type":"primary","measure":"Demonstrate the efficacy of intratumoral tilsotolimod in combination with ipilimumab and nivolumab for each cohort","time_frame":"ORR defined as a CR or partial response (PR) according to RECIST v1.1, confirmed by imaging ≥ 4 weeks after the initial documentation of response (to occur up to 24 months).","description":"Efficacy measure by objective response rate"},{"outcome_type":"primary","measure":"Duration of response","time_frame":"DOR will be evaluated every 8 weeks starting Cycle3 Day1 (each cycle is 28 days) for year 1 then every 12 weeks after the first year through study completion until all study participants have either progressive disease or start new anticancer treatment.","description":"Durability or response per RECIST v1.1"},{"outcome_type":"secondary","measure":"Safety and tolerability of the combination of tilsotolimod with nivolumab and ipilimumab","time_frame":"At every study visit (up to 48 months)","description":"Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms(ECGs), safety and laboratory parameters as assessed by CTCAE v4.03 or higher."}]}
{"nct_id":"NCT04809246","start_date":"2019-10-28","phase":"N/A","enrollment":720,"brief_title":"Prisons Evaluation of a One-stop-shop InterVentiOn","official_title":"Prisons Evaluation of a One-stop-shop InterVentiOn to Scale-up Hepatitis C Testing and Treatment (PIVOT)","primary_completion_date":"2021-08-28","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-08-28","last_update":"2021-03-22","description":"An interventional cohort study will be used to assess the effect of an intervention integrating point-of-care hepatitis C (HCV) RNA testing, non-invasive liver fibrosis assessment, same-visit direct-acting antiviral (DAA) prescription, and linkage to hepatitis care, on the proportion of participants initiating DAA therapy among people who are recently incarcerated within reception correctional centre(s) in Australia.","other_id":"VISP0105","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"None (Open Label)","intervention_model_description":"This study will be conducted as an interventional cohort study with a primary objective of assessing the effect of an intervention integrating point-of-care HCV RNA testing, non-invasive liver fibrosis assessment, same-visit DAA therapy, and linkage to hepatitis care, on the proportion of participants initiating DAA therapy among people who are recently incarcerated within reception correctional centre(s) in Australia.\r\nDuring the initial control period, all people who are newly incarcerated (in the previous six weeks) will be offered participation and will receive the standard of care with the current health service model. After a control period of approximately 12 weeks (dependent on recruitment rate) to enrol n=240 individuals, all people who are newly incarcerated (in the previous six weeks) will be offered participation in the intervention period which will continue for approximately 24 weeks (dependent on recruitment rate) to enrol n=480 individuals.","sampling_method":"","gender":"Male","minimum_age":18,"population":"","criteria":"\n        Inclusion criteria\r\n\r\n          1. has provided written, informed consent to participate;\r\n\r\n          2. is male and 18 years of age on enrolment;\r\n\r\n          3. has been incarcerated within the last six weeks;\r\n\r\n          4. is HCV DAA treatment nave;\r\n\r\n          5. is able and willing to provide informed consent and abide by the requirements of the\r\n             study.\r\n\r\n             For HCV RNA positive participants commencing treatment:\r\n\r\n          6. if HIV-1 infected must also meet the following criteria:\r\n\r\n               1. HIV infection documented by any licensed rapid HIV test or HIV enzyme or\r\n                  chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry\r\n                  (Baseline) and confirmed by a licensed Western blot or a second antibody test by\r\n                  a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 p24 antigen,\r\n                  or plasma HIV-1 RNA viral load; and\r\n\r\n               2. be on HIV antiretroviral therapy (ART) for at least 4 weeks prior to study entry\r\n                  using an ART regimen that is allowable with the selected DAA regimen as\r\n                  determined by the current PI and the Liverpool drug interaction website\r\n                  (http://www.hiv-druginteractions.org/ )\r\n\r\n        Exclusion criteria\r\n\r\n        For HCV RNA positive participants commencing treatment, the subject will be excluded if\r\n        they have:\r\n\r\n          1. untreated HIV co-infection;\r\n\r\n          2. chronic HBV co-infection;\r\n\r\n          3. any clinically significant condition, history or concomitant medication known to\r\n             contraindicate DAA therapy or would not be suitable for management within a\r\n             prison-based treatment setting;\r\n\r\n          4. is unable to gain an accurate reading on the fibroscan or the result is invalid;\r\n\r\n          5. known clinical or laboratory evidence of cirrhosis, or cirrhosis documented on\r\n             fibro-elastography (> 12.5 Kpa).\r\n      ","sponsor":"Kirby Institute","sponsor_type":"Other","conditions":"Hepatitis C","interventions":[{"intervention_type":"Other","name":"Other: 'One-stop-shop' hepatitis clinic","description":"Establishment of a 'one-stop-shop' hepatitis clinic, integrating point-of-care HCV RNA testing, followed by clinical assessment, non-invasive liver fibrosis assessment by fibro-elastography (Fibroscan), and early DAA prescription (for those with chronic HCV) followed by linkage to ongoing hepatitis care, all in the same 60-minute visit."}],"outcomes":[{"outcome_type":"secondary","measure":"The cost-effectiveness of the 'one-stop-shop' (cost-ratio of 'one-stop-shop' and standard of care)","time_frame":"End of study (estimated to be 12 months from study commencement)"},{"outcome_type":"primary","measure":"The proportion of people who have initiated DAA therapy within 12 weeks from enrolment","time_frame":"12 weeks from enrolment"},{"outcome_type":"secondary","measure":"The proportion of people tested for HCV infection at 12 weeks from enrolment","time_frame":"12 weeks from enrolment"},{"outcome_type":"secondary","measure":"The proportion of participants who complete DAA therapy in prison","time_frame":"End of Treatment (8 weeks from treatment initiation)"},{"outcome_type":"secondary","measure":"The proportion of people who have an end of treatment response","time_frame":"End of Treatment (8 weeks from treatment initiation)"},{"outcome_type":"secondary","measure":"The proportion of people who have an HCV treatment response (sustained virological response)","time_frame":"Sustained virological response at 12 weeks post treatment completion"},{"outcome_type":"secondary","measure":"The time taken from testing to each step in the care cascade","time_frame":"Varying, up to 9 months post-enrolment."},{"outcome_type":"secondary","measure":"The proportion of people lost to follow-up","time_frame":"Varying, up to end of study (estimated to be 12 months from study commencement)"},{"outcome_type":"secondary","measure":"The acceptability of the 'one-stop-shop' (proportion of prisoners who refuse to participate)","time_frame":"Varying, up to end of subject enrolment (estimated to be 12 months from study commencement)"},{"outcome_type":"secondary","measure":"The proportion of people reinfected at SVR12","time_frame":"Varying, up to 9 months post-enrolment."},{"outcome_type":"secondary","measure":"The proportion of people reporting injecting risk behaviours (at ETR and SVR12)","time_frame":"Varying, up to 9 months post-enrolment."}]}
{"nct_id":"NCT04125576","start_date":"2019-10-25","enrollment":50,"brief_title":"Comparison of Pain-Related Changes in Cerebral Blood Volume in Burn Patients With Neuropathic Pain","official_title":"Comparison of Pain-Related Changes in Cerebral Blood Volume in Burn Patients With Neuropathic Pain","primary_completion_date":"2019-12-15","study_type":"Observational [Patient Registry]","rec_status":"Recruiting","completion_date":"2019-12-20","last_update":"2019-11-14","description":"The investigators will observe increased or decreased CBV in patients with thermal injury compared with the CBV in healthy controls.","other_id":"HangangSHH-5","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":60,"population":"The patients complained of severe neuropatic pain rated at least 5 on the 10-point\r\n        numerical rating scale (NRS), despite being treated with drugs and physical therapy for\r\n        more than 1 week after being admitted to the Department of Rehabilitation Medicine.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Burn patients\r\n\r\n          -  severe neuropatic pain rated at least 5 on the 10-point numerical rating scale (NRS).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  cardiac arrest history\r\n\r\n          -  history of neurologic disease or brain surgery\r\n\r\n          -  unstable heart disease or presence of a cardiac pacemaker\r\n\r\n          -  psychiatric disorder\r\n\r\n          -  diabetes mellitus\r\n\r\n          -  abnormal renal function\r\n\r\n          -  contraindication for MRI\r\n\r\n          -  pregnancy.\r\n      ","sponsor":"Hangang Sacred Heart Hospital","sponsor_type":"Other","conditions":"Neuropathic Pain","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: magnetic resonance imaging(MRI)","description":"magnetic resonance imaging(MRI) will be used to evaluate cerebral blood volume(CBV) of pain network"}],"outcomes":[{"outcome_type":"primary","measure":"cerebral blood volume","time_frame":"1 week","description":"magnetic resonance imaging(MRI) was used to evaluate cerebral blood volume(CBV) of pain network"},{"outcome_type":"secondary","measure":"visual analogue scale","time_frame":"1 week","description":"The intensity of neuropathic pain was measured using the visual analogue scale, Zero (\"0\") represented no pain and 10 represented unbearable symptoms"}]}
{"nct_id":"NCT03825692","start_date":"2019-10-24","phase":"Phase 4","enrollment":480,"brief_title":"International Clinical Study of Zhizhu Kuanzhong Capsule","official_title":"A Multi-center, Randomized, Double-Blind, Placebo-Controlled Parallel Group Clinical Trial of Zhizhu Kuanzhong Capsule in Treating Patients With Postprandial Distress Syndrome of Functional Dyspepsia","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Enrolling by invitation","completion_date":"2022-12-31","last_update":"2021-07-14","description":"This trial aims to evaluate the clinical efficacy and safety of Zhizhu Kuanzhong Capsule in the treating patients with functional dyspepsia postprandial distress syndrome(FD PDS). Half of participants will receive Zhizhu Kuanzhong Capsule,while the other will receive a placebo.","other_id":"2017YFC1703703","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","intervention_model_description":"Randomized, double-blind, placebo-controlled, multi-center","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Meeting the Rome IV diagnostic criteria for functional dyspepsia-postprandial distress\r\n             syndrome;\r\n\r\n          2. * At least 3 days during the one-week run-in period with VAS score  4 for major\r\n             symptoms (at least one of postprandial fullness discomfort and early satiety) .\r\n\r\n          3. Age between 18 and 65 years old (including 18 and 65 years old), male or female,\r\n             outpatients;\r\n\r\n          4. **Be able to discontinue prohibited medications that may affect the evaluation of the\r\n             effectiveness, such as acid inhibition/antacids, prokinetic agents, non-steroidal\r\n             anti-inflammatory drugs, anticholinergic agents, glucocorticoids, and therapeutic\r\n             medication for H. pylori eradication.\r\n\r\n          5. Each subject is informed and voluntarily signed the informed consent form(ICF).\r\n\r\n               -  Subjects who entered the one-week run-in period are self-rated on the Visual\r\n                  Analogue Score (VAS) for the degree of discomfort with both symptoms of\r\n                  postprandial fullness and early fullness, with subjects indicating the degree of\r\n                  discomfort on a 10 cm ruler marked 0- \"Asymptomatic or No Discomfort\"and 10-\r\n                  \"Extreme Severe or Extreme Discomfort\"at its head and tail, respectively. The\r\n                  rating was made once a day and 7 days a week with scores of 0 to 10.\r\n\r\n                    -  A 2-week wash-out period is required for patients taking prohibited\r\n                       medications prior to screening.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Gastroscopic findings of gastric cancer, peptic ulcer, erosive gastritis (grade 2 or\r\n             higher), moderate to severe atrophic gastritis, dysplasia, or other organ\r\n             gastrointestinal disease.\r\n\r\n          2. Patients with a history of abdominal surgery (except for appendectomy and cesarean\r\n             section).\r\n\r\n          3. Patients with immune system defects (such as leukaemia or cancer), or those who have\r\n             been administered immunosuppressive agents or glucocorticoids within the past 3\r\n             months.\r\n\r\n          4. Patients who combined severe cardiac and pulmonary insufficiency, insufficiency of\r\n             liver (ALT/AST > 1.5 times the upper limit of the normal value) and kidney\r\n             insufficiency (BUN/Serum Creatinine > the upper limit of the normal value), abnormal\r\n             of endocrine system( such as diabetes and thyroid dysfunction), abnormal hematopoietic\r\n             system, and iron deficiency anemia as indicated on hematological examination.\r\n\r\n          5. Patients with severe anxiety and depression.\r\n\r\n          6. Patients with psychosis and mental retardation as well as language disorder precluding\r\n             the ability of filling scales or recording symptoms.\r\n\r\n          7. Pregnant (a female of childbearing potential with a positive pregnancy test) or\r\n             lactating females; or patients of childbearing potential without effective\r\n             contraception.\r\n\r\n          8. Patients who are known to be allergic to the ingredients of this drug.\r\n\r\n          9. Patients who are suspected to have or indeed have a history of alcohol or drug abuse.\r\n\r\n         10. Patients who have participated in a clinical trial in the past 3 months.\r\n\r\n         11. Patients who are deemed by the investigator as being not suitable for participation in\r\n             the clinical trial.\r\n      ","sponsor":"Xiyuan Hospital of China Academy of Chinese Medical Sciences","sponsor_type":"Other","conditions":"Functional Dyspepsia|Postprandial Distress Syndrome","interventions":[{"intervention_type":"Drug","name":"Drug: Zhizhu Kuanzhong Capsule","description":"Zhizhu Kuanzhong Capsule, 3 capsules at a time, 3 times a day, taken orally 10-15 min before meals. an 8-week intervention period"},{"intervention_type":"Drug","name":"Drug: Zhizhu Kuanzhong Placebo Capsule","description":"Placebo, 3 capsules at a time, 3 times a day, taken orally 10-15 min before meals. an 8-week intervention period"}],"outcomes":[{"outcome_type":"primary","measure":"The proportion of the response at 8 weeks after randomization","time_frame":"up to 8 weeks","description":"Subjects with the functional dyspepsia-postprandial distress syndrome are self-rated on the Visual Analogue Score (VAS) which is a scale of 0-10, with subjects indicating the degree of discomfort on a 10 cm ruler marked 0- \"Asymptomatic or No Discomfort \"to 10- \"Extreme Severe or Extreme Discomfort \"at its head and tail, respectively. The record is made once a day and 7 days a week via a diary card. For VAS scores for postprandial fullness discomfort and early satiety, the integral average for both symptoms over the past week is evaluated, and a 50% decrease from baseline in the integral average at 8 Weeks is recorded as a response."},{"outcome_type":"secondary","measure":"The change of VAS score of each symptom of functional dyspepsia","time_frame":"Up to 8 weeks","description":"On the diary cards, subjects recorded the Visual Analogue Score (VAS) of each symptom of the functional dyspepsia daily. VAS is scored on a scale of 0-10 which the higher the score, the severer the symptom is. The record is made once a day and 7 days. The investigators use the average of the weekly VAS scores as the symptom intensity score for this week, with one VAS score per week. The change in the score of each symptom at 8 weeks after randomization relative to the baseline is evaluated."},{"outcome_type":"secondary","measure":"Overall treatment response rate","time_frame":"Up to 8 weeks","description":"The overall treatment efficacy is evaluated using a 7-point Likert Overall Evaluation Scale (OTE). The clinical investigators asked the subjects the following questions weekly: \"In the last week, how much have your dyspeptic symptoms been alleviated as compared to pre-treatment? \" There are 7 options: ① the symptoms improved significantly, ② the symptoms improved, ③ the symptoms improved slightly, ④ the symptoms did not change, ⑤ the symptoms aggravated slightly, ⑥ the symptoms aggravated, ⑦ the symptoms aggravated significantly. At the last visit time point of the treatment cycle, patients who selected ① and ② were defined as treatment responders, and those who selected ③-⑦ were defined as non-responders. The response rate at 8 weeks after randomization between the groups are compared for differences."},{"outcome_type":"secondary","measure":"Short Form Nepean Dyspepsia Index (SFNDI)","time_frame":"Up to 8 weeks","description":"Short Form-Nepean Dyspepsia Index (SFNDI) is a reliable and valid measure of quality of life in functional dyspepsia with 10 items which questions are about how subjects stomach pain, discomfort, or other epigastric symptoms over the last 14 days affect their lives. Add up the ten items for each of the five sub-scale scores (range of each sub-scale 2-10). The changes of SFNDI score at 4 weeks and 8 weeks after randomization relative to the baseline are calculated."},{"outcome_type":"secondary","measure":"Hospital Anxiety and Depression Scale score","time_frame":"Up to 8 weeks","description":"The Hospital Anxiety and Depression Scale (HAD) is mainly used in patients in general hospitals which provides two sets of tests to assess the state of anxiety and depression, respectively. Among them, A stands for anxiety items, D stands for depression items, and each item is scored at four levels. Each of the two sets of items are superimposed to obtain their respective total score. A total score of 0 to 7 indicates normal, 8 to 10 indicates borderline abnormal, and 11 to 21 indicates abnormal. The changes of HAD score at 4 weeks and 8 weeks after randomization relative to the baseline are calculated."}]}
{"nct_id":"NCT04257422","start_date":"2019-10-21","phase":"N/A","enrollment":1741,"brief_title":"Intentional Rounding in Internal Medicine","official_title":"Intentional Rounding in Internal Medicine: a Multicenter, Randomized National Study Studio INTENTO - FADOI.03.2018","primary_completion_date":"2020-01-21","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2020-02-29","last_update":"2020-02-17","description":"Each investigator will have to collect data for 50 hospitalized patients in the Internal Medicine wards. If the center is randomized to Intentional Rounding, the staff of nurses and OSS will have to implement the new care strategy.","other_id":"FADOI.03.2018","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","intervention_model_description":"Cluster randomized","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age  18 years\r\n\r\n          -  Signature of informed consent\r\n\r\n          -  Patients who understand Italian\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who deny informed consent\r\n      ","sponsor":"Fadoi Foundation, Italy","sponsor_type":"Other","conditions":"Hospitalization","interventions":[{"intervention_type":"Other","name":"Other: Intentional Rounding","description":"A new method of nursing care named Intentional Rounding. The \"intentional roundings\" are planned rounds, conducted at regular intervals by nursing staff to anticipate care, comfort, hospitality and psychological needs of hospitalized users."}],"outcomes":[{"outcome_type":"primary","measure":"Falls and new bedsores","time_frame":"3 months","description":"Cumulative assessment of the incidence of falls and the appearance of new pressure sores in hospitalized patients in the Internal Medicine wards"},{"outcome_type":"secondary","measure":"Call lights","time_frame":"3 months","description":"Analysis of the impact of the implementation of Intentional Rounding on the call lights by hospitalized patients.\r\nThe total number of calls to the emergency bell is evaluated. A call light log will be used on which the nurses will report the reason for each call by the patient."},{"outcome_type":"secondary","measure":"Measurement of patient satisfaction with the nursing care received and hospitalization","time_frame":"3 months","description":"Assessment of the relationship between implementation of the Intentional Rounding and level of patient satisfaction, defined on the basis of how patients consider the way care is provided useful, effective and advantageous (for patients able to perform this evaluation).\r\nThe information will be collected through a questionnaire consisting of two questions. The patient will have to evaluate the nursing care and hospitalization, assigning a score from 1 to 7 (where 1 = bad; 7 = excellent)."},{"outcome_type":"secondary","measure":"Critical thinking of nurses","time_frame":"3 months","description":"Evaluation of the critical thinking of nurses following the implementation of Intentional Rounding in clinical practice, defined as the process that is used by nurses when they have to make a clinical decision and manage daily problems (on a voluntary basis between the participating Centers).\r\nClinical decision making in nursing scale (CDMNS) will be used to evaluate the critical thinking of nurses.\r\nFor each of the 40 statements, the nurse must think about how she would behave during patient care.\r\nThere are no \"right\" or \"wrong\" answers. What matters is his evaluation of how he usually acts in making decisions in clinical reality.\r\nThe answers can be:\r\nAlways: what he constantly does every time.\r\nFrequently: what he usually does in most cases.\r\nOccasionally: what he does a few times.\r\nRarely: what he seldom does."}]}
{"nct_id":"NCT04016272","start_date":"2019-10-18","phase":"N/A","enrollment":120,"brief_title":"Self-Administered Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis: A Phase II Randomized Sham-Controlled Trial","official_title":"Self-Administered Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis: A Phase II Randomized Sham-Controlled Trial","primary_completion_date":"2022-07-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-07-31","last_update":"2021-09-16","description":"The purpose of this study is to assess the feasibility, acceptability, and efficacy of self-administered transcranial direct current stimulation (tDCS) in older adults with knee osteoarthritis (OA)","other_id":"HSC-SN-19-0469","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":50,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  have symptomatic knee OA based on American College of Rheumatology Clinical criteria\r\n\r\n          -  have had knee OA pain in the past 3 months with an average of at least 30 on a 0-100\r\n             NRS for pain\r\n\r\n          -  can speak and read English\r\n\r\n          -  have no plan to change medication regimens for pain throughout the trial\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  prosthetic knee replacement or nonarthroscopic surgery to the affected knee\r\n\r\n          -  history of brain surgery, brain tumor, seizure, stroke or intracranial metal\r\n             implantation\r\n\r\n          -  systemic rheumatic disorders, including rheumatoid arthritis, systemic lupus\r\n             erythematosus, and fibromyalgia\r\n\r\n          -  alcohol/substance abuse\r\n\r\n          -  current use of sodium channel blockers, calcium channel blockers and NMDS receptor\r\n             antagonists\r\n\r\n          -  diminished cognitive function that would interfere with understanding study\r\n             procedures(i.e., Mini-Mental Status Exam score  23)\r\n\r\n          -  pregnancy or lactation\r\n\r\n          -  hospitalization within the preceding year for psychiatric illness\r\n\r\n          -  no access to a device with internet access that can be used for secure\r\n             videoconferencing for real-time remote supervision\r\n      ","sponsor":"Florida State University","sponsor_type":"Other","conditions":"Osteo Arthritis Knee","interventions":[{"intervention_type":"Device","name":"Device: Active tDCS","description":"tDCS with a constant current intensity of 2 mA will be applied for 20 minutes per session daily for 2 weeks (Monday to Friday) via the Soterix 1x1 tDCS mini-CT Stimulator device (Soterix Medical Inc., NY) with headgear and saline-soaked surface sponge electrodes."},{"intervention_type":"Device","name":"Device: Sham tDCS","description":"For sham stimulation, the electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds."}],"outcomes":[{"outcome_type":"secondary","measure":"Feasibility as assessed by the number of participants that complete the full tDCS protocol","time_frame":"week 3"},{"outcome_type":"primary","measure":"Change in clinical pain as assessed by the numeric rating scale (NRS) for pain","time_frame":"baseline, week 3","description":"The NRS total score ranges from 0 (no pain) to 100 (most intense pain imaginable)."},{"outcome_type":"secondary","measure":"Change in pain related cortical response using a continuous wave, multichannel Functional near-infrared spectroscopy (fNIRS) imaging system","time_frame":"Baseline, week 3","description":"Pain-related cortical response will be measured using a continuous-wave, multichannel fNIRS imaging system (LIGHTNIRS, Shimadzu, Kyoto, Japan) with three semiconductor lasers at 780, 805, and 830 nm. Optical recordings will be collected during thermal pain stimulation."},{"outcome_type":"secondary","measure":"Acceptability as measured by the tDCs experience questionnaire","time_frame":"week 3","description":"The questionnaire is based on scale from 0-10, 0 being strongly disagree and 10 being strongly agree for a total maximum score of a 100, with higher scores indicating greater acceptibility."},{"outcome_type":"secondary","measure":"Number of participants with possible side effects of treatment","time_frame":"week 3"}]}
{"nct_id":"NCT04069936","start_date":"2019-10-15","phase":"Phase 2","enrollment":19,"brief_title":"Marrow Infiltrating Lymphocytes - Non-Small Cell Lung Cancer (MILs - NSCLC) Alone or in Combination With Nivolumab With or Without Tadalafil in Locally Advanced and Unresectable or Metastatic NSCLC","official_title":"A Phase 2a, Open-Label, Multi-Center Study to Assess the Efficacy and Safety of Marrow Infiltrating Lymphocytes - Non-Small Cell Lung Cancer (MILs - NSCLC) Alone or in Combination With Nivolumab With or Without Tadalafil in Subjects With Locally Advanced and Unresectable or Metastatic NSCLC Previously Treated With Anti-PD-1","primary_completion_date":"2022-08-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2027-03-31","last_update":"2021-06-18","description":"The purpose of this study is to determine the safety and efficacy of MILs - NSCLC alone and in combination with nivolumab with or without tadalafil in subjects with locally advanced and unresectable or metastatic NSCLC who are refractory or relapsing to a PD-1 containing regimen.","other_id":"CLN-P18001","allocation":"N/A","intervention_model":"Sequential Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"In Part 1, approximately 3-6 subjects will be treated with MILs - NSCLC alone. Following Part 1, approximately 20 subjects will be treated with MILs - NSCLC plus nivolumab with or without tadalafil.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.\r\n\r\n          2. Locally advanced and unresectable, or metastatic NSCLC.\r\n\r\n          3. Histologically or cytologically confirmed, either squamous or non-squamous NSCLC.\r\n\r\n          4. Measurable disease as per RECIST 1.1\r\n\r\n          5. Willingness to undergo bone marrow aspiration (BMA).\r\n\r\n          6. No more than one treatment regimen following an anti-PD-1 antibody containing\r\n             treatment regimen prior to BMA collection.\r\n\r\n             a. Subjects may have BMA collected while on an anti-PD-1 antibody containing treatment\r\n             regimen or while on a treatment regimen immediately following an anti-PD-1 antibody\r\n             containing treatment regimen.\r\n\r\n          7. BMA may be collected while on an anti-PD-1 antibody containing treatment regimen or\r\n             while on a treatment regimen immediately following an anti-PD-1 antibody containing\r\n             treatment regimen. However, the subjects must have radiographic evidence of disease\r\n             progression prior to lymphodepletion.\r\n\r\n          8.  21 days have lapsed since last cytotoxic chemotherapy treatment prior to collection\r\n             of the BMA.\r\n\r\n          9. Previous treatment with the appropriate targeted therapy if the subject has known\r\n             EGFR/ALK/ROS1 rearrangements.\r\n\r\n         10. Willingness to provide a fresh tumor biopsy during Screening Period or formalin-fixed,\r\n             paraffin-embedded tissue collected at the time of most recent relapse. Note: Archival\r\n             tissue regardless of biopsy date may be considered.\r\n\r\n         11. Adequate renal, hepatic and bone marrow function defined as total bilirubin <\/= 1.5 x\r\n             ULN (except for subjects with Gilbert's disease  3.0 x ULN with direct bilirubin <\/=\r\n             1.5 x ULN ). Aminotransferase (AST) / Alanine Aminotransferase (ALT) <\/= 3.0 X ULN\r\n             (subjects with liver involvement will be allowed <\/= 5.0 X ULN). Serum creatinine <\/=\r\n             1.5 x ULN; if serum creatinine is 1.5 to 2.0  ULN, then the creatinine clearance\r\n             (calculated using the Cockcroft-Gault formula or measured) must be  40 mL/min.\r\n             Lymphocyte >/= 0.7 x 10^9/L. ANC >/= 1.5 x 10^9/L. Platelets >/= 100  10^9/L. WBC >/=\r\n             2.0 10^9/L. Hemoglobin > 9.0 g/dL.\r\n\r\n         12. Women of childbearing potential and male subjects (even if they are surgically\r\n             sterilized or had a vasectomy) and their partners must agree to abstain or to use an\r\n             effective form of birth control during the study for at least 6 months following\r\n             administration of the last dose of lymphodepletion or for at least 5 months following\r\n             the last dose of nivolumab for females and 7 months for males, whichever is longer. In\r\n             addition, male subjects must not donate sperm during this period.\r\n\r\n         13. Capable of giving and has provided a signed ICF, which includes compliance with the\r\n             requirements and restrictions listed in the ICF and in this protocol.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Insufficient activation/expansion of T cells or other problems with the subject's\r\n             MILs - NSCLC product which would prohibit administration.\r\n\r\n          2. Major surgical procedure within 7 days of the first dose of lymphodepletion treatment.\r\n\r\n          3. Prior malignancy active within the previous 3 years from date of BMA collection except\r\n             for locally curable cancers that have been apparently cured, such as basal or squamous\r\n             cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate,\r\n             cervix, or breast.\r\n\r\n          4. Subjects with symptomatic uncontrolled brain metastases requiring treatment with\r\n             steroids or anti-seizure medications within 28 days prior to the BMA are excluded.\r\n             However, participants with brain metastases that have been previously treated and are\r\n             stable on subsequent scan(s) are allowed and subjects with untreated possible brain\r\n             metastases that are new at the time of screening and are < 1 cm and asymptomatic are\r\n             allowed. Subjects with asymptomatic untreated CNS disease may undergo BMA prior to\r\n             treatment of such disease.\r\n\r\n          5. Infection requiring treatment with intravenous antibiotics, antifungal, or antiviral\r\n             agents within 7 days prior to the BMA.\r\n\r\n          6. Presence of an autoimmune disease requiring active systemic treatment.\r\n\r\n          7. Clinically significant, uncontrolled cardiovascular disease, including congestive\r\n             heart failure Grade III or IV according to the New York Heart Association\r\n             classification, myocardial infarction or unstable angina within the previous 6 months\r\n             prior to BMA collection.\r\n\r\n          8. Known diagnosis of human immunodeficiency virus (HIV) or active viral hepatitis.\r\n\r\n          9. Administration of neutrophil growth factor support within 14 days prior to the BMA.\r\n\r\n         10. Use of systemic corticosteroids (glucocorticoids) for greater than one day within 28\r\n             days prior to the BMA.\r\n\r\n         11. Planned use of systemic corticosteroids (glucocorticoids) for greater than one day\r\n             within 28 days prior to MILs - NSCLC administration.\r\n\r\n         12. Prior radiation to both sides of the pelvis. Prior radiation to one side of the pelvis\r\n             is permitted as long as the other side of the pelvis.\r\n\r\n         13. Subjects with history of life-threatening toxicity related to prior immune therapy\r\n             except those that are unlikely to re-occur with standard countermeasures.\r\n\r\n         14. Receipt of live attenuated vaccine within 30 days of planned Day 0.\r\n\r\n         15. History of allergy or hypersensitivity to MILs-NSCLC, cyclophosphamide, fludarabine,\r\n             nivolumab, tadalafil or their components.\r\n\r\n         16. Pregnant or lactating females.\r\n\r\n         17. Prior or ongoing clinically significant illness, medical condition, surgical history,\r\n             physical finding, or laboratory abnormality that, in the Investigator's opinion, could\r\n             affect the safety of the subject or impair the assessment of study results.\r\n\r\n         18. Unwilling or unable to comply with the protocol.\r\n      ","sponsor":"WindMIL Therapeutics","sponsor_type":"Industry","conditions":"Non Small Cell Lung Cancer|Lung Cancer|Lung Cancer Metastatic|Lung Cancer, Non-small Cell|Non Small Cell Lung Cancer Metastatic|NSCLC|Non-small Cell Lung Cancer|Non-small Cell Lung Cancer Metastatic","interventions":[{"intervention_type":"Biological","name":"Biological: MILs - NSCLC","description":"To evaluate the safety of MILs - NSCLC alone in subjects with locally advanced and unresectable or metastatic NSCLC"},{"intervention_type":"Biological","name":"Biological: nivolumab","description":"To evaluate the efficacy of MILs - NSCLC in combination with nivolumab in subjects with locally advanced and unresectable or metastatic NSCLC"},{"intervention_type":"Drug","name":"Drug: tadalafil","description":"To evaluate the efficacy of MILs - NSCLC in combination with nivolumab with or without tadalafil in subjects with locally advanced and unresectable or metastatic NSCLC"}],"outcomes":[{"outcome_type":"secondary","measure":"Safety of MILs™ - NSCLC alone and in combination with nivolumab with or without tadalafil by electrocardiograms (ECGs) assessed by Investigators as normal, abnormal clinically significant or abnormal not clinically significant","time_frame":"From ICF through 100 days after the last dose of study treatment","description":"ECGs results will be summarized and changes from baseline provided"},{"outcome_type":"primary","measure":"Adverse Events per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0","time_frame":"From ICF through 100 days after the last dose of study treatment","description":"Incidence, intensity, and type of AE"},{"outcome_type":"primary","measure":"Serious Adverse Events per NCI-CTCAE version 5.0","time_frame":"From ICF through 100 days after the last dose of study treatment","description":"Incidence, intensity, and type of SAE"},{"outcome_type":"primary","measure":"Overall Response Rate (ORR) of MILs™ - NSCLC in combination with nivolumab with or without tadalafil","time_frame":"24 months","description":"Proportion of subjects with reduction in tumor burden of a predefined amount per RECIST 1.1"},{"outcome_type":"secondary","measure":"Duration of response","time_frame":"up to 5 years after treatment discontinuation","description":"Duration from first documented evidence of CR or PR until the first documented evidence of PD or death due to any cause, whichever occurs first"},{"outcome_type":"secondary","measure":"Disease control rate","time_frame":"up to 5 years after treatment discontinuation","description":"Proportion of subjects in the efficacy population who achieve an Investigator-assessed confirmed CR, PR, or SD per RECIST 1.1"},{"outcome_type":"secondary","measure":"Progression-free survival","time_frame":"up to 5 years after treatment discontinuation","description":"Date of first the administration of MILs™ - NSCLC until documented PD or death due to any cause, whichever occurs first"},{"outcome_type":"secondary","measure":"Overall survival","time_frame":"up to 5 years after treatment discontinuation","description":"Duration from the date of administration of MILs™ - NSCLC until death due to any cause"},{"outcome_type":"secondary","measure":"Overall Response Rate (ORR) of MILs™ - NSCLC","time_frame":"24 months","description":"Proportion of subjects with reduction in tumor burden of a predefined amount per RECIST 1.1"},{"outcome_type":"secondary","measure":"Safety of MILs™ - NSCLC alone and in combination with nivolumab with or without tadalafil as assessed by vital signs (pulse rate)","time_frame":"From ICF through 100 days after the last dose of study treatment","description":"Pulse rate in beats/minute"},{"outcome_type":"secondary","measure":"Safety of MILs™ - NSCLC alone and in combination with nivolumab with or without tadalafil as assessed by vital signs (weight)","time_frame":"From ICF through 100 days after the last dose of study treatment","description":"Weight in pounds"},{"outcome_type":"secondary","measure":"Safety of MILs™ - NSCLC alone and in combination with nivolumab with or without tadalafil as assessed by vital signs (blood pressure)","time_frame":"From ICF through 100 days after the last dose of study treatment","description":"Systolic and diastolic blood pressure in mmHg"},{"outcome_type":"secondary","measure":"Safety of MILs™ - NSCLC alone and in combination with nivolumab with or without tadalafil as assessed by vital signs (respiratory rate)","time_frame":"From ICF through 100 days after the last dose of study treatment","description":"Respiratory rate in breaths/minute"},{"outcome_type":"secondary","measure":"Safety of MILs™ - NSCLC alone and in combination with nivolumab with or without tadalafil as assessed by vital signs (temperature)","time_frame":"From ICF through 100 days after the last dose of study treatment","description":"Termperature in Fahrenheit"},{"outcome_type":"secondary","measure":"Safety of MILs™ - NSCLC alone and in combination with nivo. with or w/o tadalafil by liver function (ALT/AST (U/L), albumin (g/dL), tot. bilirubin (mg/dL)), kidney function (creatinine (mg/dL) and endocrine function (T3 free and T4 free (ng/dL))","time_frame":"From ICF through 100 days after the last dose of study treatment","description":"Clinical chemistry results will be summarized and changes from baseline provided"},{"outcome_type":"secondary","measure":"Safety of MILs™ - NSCLC alone and in combination with nivolumab with or without tadalafil by cell count (e.g. RBC (10^6/uL), WBC (10^3/uL), absolute cell count (10^3/uL), Hct (%) and Hgb (g/dL)","time_frame":"From ICF through 100 days after the last dose of study treatment","description":"Hematology results will be summarized and changes from baseline provided"},{"outcome_type":"secondary","measure":"Safety of MILs™ - NSCLC alone and in combination with nivolumab with or without tadalafil as assessed by APTT (seconds), fibrinogen (mg/dL), INR and protime (seconds)","time_frame":"From ICF through 100 days after the last dose of study treatment","description":"Coagulation results will be summarized in data listings"},{"outcome_type":"secondary","measure":"Safety of MILs™ - NSCLC alone and in combination with nivolumab with or without tadalafil as assessed by urine appearance, color, pH, specific gravity and presence of blood, bilirubin, glucose, ketone, leukocyte esterase, nitrite, protein, urobilinogen","time_frame":"From ICF through 100 days after the last dose of study treatment","description":"Urinalysis results will be summarized in data listings"},{"outcome_type":"secondary","measure":"Safety of MILs™ - NSCLC alone and in combination with nivolumab with or without tadalafil by physical examination with abnormalities reported as adverse events","time_frame":"From ICF through 100 days after the last dose of study treatment","description":"Physical examinations will be performed by the Investigators and any new clinically significant or changes in medical conditions will be reported as adverse events"}]}
{"nct_id":"NCT03876457","start_date":"2019-10-11","phase":"N/A","enrollment":560,"brief_title":"SELECT 2: A Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke","official_title":"SELECT 2: A Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke","primary_completion_date":"2021-11-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-11-01","last_update":"2021-04-28","description":"SELECT 2 evaluates the efficacy and safety of endovascular thrombectomy compared to medical management alone in acute ischemic stroke patients due to a large vessel occlusion in the distal ICA and MCA M1 who have large core on either CT (ASPECTS: 3-5) or advanced perfusion imaging ([rCBF<30%] on CTP or [ADC<620] on MRI: 50cc) or both and are treated within 0-24 hours from last known well. The second aim is to look at the correlation of imaging profiles with thrombectomy clinical outcomes and treatment effect. This will be evaluated by comparing the outcomes in patients with discordant imaging profile and assessing if thrombectomy outcome rates and treatment effect will differ in patients with discordant imaging profiles (favorable CT/unfavorable perfusion imaging and unfavorable CT/favorable perfusion imaging).","other_id":"G180275, HSC-MS-18-0997","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Adults (18-85 years) with the final diagnosis of an acute ischemic stroke\r\n\r\n          2. NIH Stroke Scale Score (NIHSS)  6\r\n\r\n          3. Last known well to groin puncture or medical management between 0 to 24 hours\r\n\r\n          4. Pre-stroke modified Rankin Scale score (mRS) of 0-1\r\n\r\n          5. Eligible for thrombectomy with stent retriever or medical management\r\n\r\n          6. Signed Informed Consent obtained\r\n\r\n          7. Subject willing to comply with the protocol follow-up requirements\r\n\r\n          8. Anticipated life expectancy of at least 3 months\r\n\r\n        Specific Neuroimaging Inclusion Criteria:\r\n\r\n          1. Proven large vessel occlusion in ICA or MCA-M1 occlusion (carotid occlusions can be\r\n             cervical or intracranial, with or without tandem MCA lesions) determined by MRA or CTA\r\n\r\n          2. Large infarct-core lesion on at least one of the following:\r\n\r\n               -  2.1. Non-Contrast CT (ASPECTS of 3-5),\r\n\r\n               -  2.2. CT perfusion (rCBF<30% 50cc),\r\n\r\n               -  2.3. MRI-DWI (ADC<620 50cc)\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Inability to undergo CT angiography and/or CT perfusion imaging (e.g., renal\r\n             insufficiency, iodine/contrast allergy)\r\n\r\n          2. Co-morbid psychiatric or medical illnesses that would confound the neurological\r\n             assessments\r\n\r\n          3. Treatment with tPA beyond 4.5 hours from last known well\r\n\r\n          4. Treated with tPA 3-4.5 hours after last known well AND any of the following:\r\n\r\n               -  1) age >80,\r\n\r\n               -  2) current anticoagulant use,\r\n\r\n               -  3) history of diabetes AND prior stroke,\r\n\r\n               -  4) NIHSS >25,\r\n\r\n               -  5) ischemic involvement of > 1/3 MCA territory\r\n\r\n          5. Current participation in another investigational drug or device study.\r\n\r\n        Neuroimaging Exclusion Criteria\r\n\r\n          1. Patients who have both ASPECTS of 6-10 on non-contrast CT AND core volume <50 cc on\r\n             perfusion imaging\r\n\r\n          2. Patients with very large core on non-contrast CT i.e. ASPECTS  2\r\n\r\n          3. Evidence of intracranial tumor (except small meningioma), acute intracranial\r\n             hemorrhage, neoplasm, or arteriovenous malformation\r\n\r\n          4. A significant mass effect with midline shift\r\n\r\n          5. Evidence of internal carotid artery dissection that is flow limiting or aortic\r\n             dissection\r\n\r\n          6. Intracranial stent implanted in the same vascular territory that precludes the safe\r\n             deployment/removal of the neurothrombectomy device\r\n\r\n          7. Acute symptomatic arterial occlusions in more than one vascular territory confirmed on\r\n             CTA/MRA (e.g., bilateral MCA occlusions, or an MCA and a basilar artery occlusion).\r\n\r\n          8. Signs of established infarct and large area of cerebral edema on non-contrast CT\r\n      ","sponsor":"The University of Texas Health Science Center, Houston","sponsor_type":"Other","conditions":"Acute Ischemic Stroke","interventions":[{"intervention_type":"Device","name":"Device: Endovascular thrombectomy with stent retrievers: Trevo, Solitaire, and EmboTrap Revascularization Device","description":"Patients randomized to endovascular thrombectomy arm will receive thrombectomy plus medical management. They will be treated with thrombectomy devices (stent-retrievers) with/without suction thrombectomy systems currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke within 24 hours of symptom onset. The devices which will be used are the Trevo Retriever, the Solitaire Revascularization Device and EmboTrap Revascularization Device. Stent retrievers will be used as the primary mode of thrombectomy with adjunctive use of the aspiration devices approved by the FDA (MicroVention SOFIA Catheter, and the Penumbra thrombectomy system) permitted in the study."},{"intervention_type":"Other","name":"Other: Medical Management","description":"Patients will receive standard AHA guideline-directed medical therapy, which will include IV-tPA in patients presenting within the first 4.5 hours from last-seen-normal and meeting other FDA label criteria and/or AHA guidelines. For non-tPA treated patients, this will include aspirin 325 mg on day 1 followed by aspirin 81 mg or 325 mg thereafter, which will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-tPA patients will be treated based on standard study site protocols for these patients."}],"outcomes":[{"outcome_type":"primary","measure":"Change in Modified Rankin Scale (mRS) score","time_frame":"baseline, 90 days","description":"The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with \"0\" being perfect health without symptoms to \"6\" being death.\r\nScore 0: No symptoms Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms.\r\nScore 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.\r\nScore 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.\r\nScore 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent.\r\nScore 6: Dead"},{"outcome_type":"primary","measure":"Number of participants with favorable clinical outcomes defined as mRS scores of 0-2.","time_frame":"90 days","description":"The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with \"0\" being perfect health without symptoms to \"6\" being death.\r\nScore 0: No symptoms Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms.\r\nScore 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.\r\nScore 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.\r\nScore 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent.\r\nScore 6: Dead"},{"outcome_type":"secondary","measure":"Number of participants with symptomatic intracranial hemorrhage (sICH) per SITS-MOST","time_frame":"Up to 24 hours after randomization","description":"NIHSS worsening of 4 or more points associated with sICH per Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST) definition assessed within 24 hours after randomization"},{"outcome_type":"secondary","measure":"Mortality","time_frame":"90 days"},{"outcome_type":"secondary","measure":"Number of participants with groin hematomas, infections or any vascular injury cause by the endovascular procedure","time_frame":"Up to 72 hours after procedure"},{"outcome_type":"secondary","measure":"Length of hospital stay","time_frame":"From admission date to discharge date (about 1 week)"},{"outcome_type":"secondary","measure":"Discharge location","time_frame":"discharge (about 1 week after randomization)"},{"outcome_type":"secondary","measure":"NIH Stroke Scale score at 24 hours","time_frame":"24 hours after randomization"},{"outcome_type":"secondary","measure":"NIH Stroke Scale score at discharge or day 5-7 (whichever comes earlier)","time_frame":"at discharge (which is about 1 week after randomization) or Day 5-7, whichever comes earlier"},{"outcome_type":"secondary","measure":"Neuro-QoL score","time_frame":"90 days"},{"outcome_type":"secondary","measure":"Infarct volume","time_frame":"24 to 72 hours after randomization","description":"Infarct volume on MRI diffusion-weighted imaging (DWI) sequence (or CT if MRI not feasible) 24 to 72 hours after randomization"},{"outcome_type":"secondary","measure":"Lesion growth","time_frame":"24 to 72 hours after randomization","description":"Lesion growth between the RAPID identified ischemic core on baseline imaging and the infarct volume"},{"outcome_type":"secondary","measure":"Number of participants with successful reperfusion","time_frame":"24 to 72 hours after randomization","description":"Successful reperfusion defined as DWI lesion volume minus Tmax>6 seconds greater than 50%"},{"outcome_type":"secondary","measure":"Number of participants with recanalization of the primary arterial occlusive lesion","time_frame":"24 hours after randomization","description":"Recanalization of the primary arterial occlusive lesion, assessed by a modified Thrombolysis in Cerebral Infarction scores of 2b (50% to 75% reperfusion), 2c (>75% to 99% reperfusion) or 3 (complete reperfusion)"}]}
{"nct_id":"NCT04082416","start_date":"2019-10-10","phase":"Phase 3","enrollment":335,"brief_title":"Study of Recombinant Human B Lymphocyte(RC18) Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE)","official_title":"A Phase III, Placebo-Controlled ,Multi-Center, Randomized, Double-Blind, Dose-exploring Trial of RC18,a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Systemic Lupus Erythematosus (SLE).","primary_completion_date":"2021-10-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2021-12-31","last_update":"2021-04-28","description":"The purpose of this study is to initially access the safety and effectivity of RC18 combined with standard treatment and Placebo combined with standard therapy in subjects with Moderate to severe SLE.","other_id":"18C010","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Active SLE disease#and at least according with 4 of the 11 items of the American\r\n             College of Rheumatology (ACR) criteria 1997.\r\n\r\n          -  Age & Gender: Male or female between 18 and 65 years of age inclusive#and the sex\r\n             ratio is not limited\r\n\r\n          -  Signed informed consent form#willing or able to participate in all required study\r\n             evaluations and procedures.\r\n\r\n          -  SELENA-SLEDAI(Safety of Estrogens in Lupus Erythematosus National Assessment SLE\r\n             Disease Activity Index) score  8 during the screening period.and if there is\r\n             Hypo-complement or the Anti-dsDNA score, SELENA-SLEDAI disease activity score should\r\n             be at least 6 at screening .\r\n\r\n          -  Autoantibody-positive\r\n\r\n          -  on a stable SLE treatment regimen for at least 30 days prior to Day 1, which consisted\r\n             of any of the following (alone or in combination): cortical\r\n             hormone,anti-malarials,non-steroidal anti inflammatory drugs (NSAIDs),or any\r\n             immunosuppressive and immunomodulator therapy(i.e.,azathioprine,mycophenolate\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  kidney disease Severe lupus nephritis 8 weeks prior to randomization (designed\r\n             as:Urine protein>6g/24h or serum creatinine ( SCr>2.5mg/dL or 221umol/L ) or needing\r\n             for hemodialysis or receipting high dose cortical hormone 14 days(\r\n             metacortandracin>100mg/d or equivalent)\r\n\r\n          -  Central nervous system disease caused by SLE or non SLE 8 weeks prior to randomization\r\n             (including epilepsy mental diseaseorganic encephalopathy syndromecerebrovascular\r\n             accident, encephalitis, central nervous system vasculitis;\r\n\r\n          -  there are serious heart, liver, kidney and other important organs and blood, endocrine\r\n             system diseases and medical history;\r\n\r\n        Evaluation criteria for severity :\r\n\r\n          1. Alanine aminotransferase#ALT#or aspartate aminotransferase (AST) 2 upper limit of\r\n             normal (ULN);\r\n\r\n          2. Creatinine Clearance (Ccr)<30ml/min;\r\n\r\n          3. White Blood Cell Count(WBCs)<2.5x 10(9)/L;\r\n\r\n          4. hemoglobin<85g/L;\r\n\r\n          5. Platelets<50x 10(9)/L.\r\n\r\n               -  Have a historically active hepatitis or active hepatitis or medical\r\n                  history,hepatitis B :Patients with positive HBsAg are excluded.;Hepatitis C:\r\n                  Patients with hepatitis C antibody positive are excluded;\r\n\r\n               -  Immune deficiency, uncontrolled severe infection and patients with active or\r\n                  recurrent peptic ulcer;\r\n\r\n               -  Pregnant , lactating women and men or women who have birth plans in the past 12\r\n                  months ;\r\n\r\n               -  Have a history of allergic reaction to human biological medicines.\r\n\r\n               -  Receipt of live vaccine within 1 month;\r\n\r\n               -  Have participated in any clinical trial in the first 28 days of the initial\r\n                  screening or 5 times half-life period of the study compound (taking the time for\r\n                  the elderly).\r\n\r\n               -  Have received treatment with B cell targeted therapy such as Rituximab or\r\n                  Epratuzumab etc.\r\n\r\n               -  Receipt of anti-tumor necrosis factor#interleukin receptor antagonist#\r\n\r\n               -  Receipt of IV immunoglobulin(IVIG),prednisone>100mg/d more than 14 days or plasma\r\n                  exchange;\r\n\r\n               -  There are active infections (such as herpes zoster, human immunodeficiency virus\r\n                  (HIV) virus infection, active tuberculosis, etc.) during the screening period;\r\n\r\n               -  Patients have depression or the significant suicide ideation;\r\n\r\n               -  Interleukin(IL)-2, thalidomide, Tripterygium wilfordii and traditional Chinese\r\n                  medicine preparation containing Tripterygium Wilfordii were used within 28 days\r\n                  before randomization\r\n\r\n               -  Investigator considers candidates not appropriating for the study.\r\n      ","sponsor":"RemeGen Co., Ltd.","sponsor_type":"Industry","conditions":"Systemic Lupus Erythematosus","interventions":[{"intervention_type":"Biological","name":"Biological: Placebo plus standard therapy","description":"Standard therapy comprises any of the following (alone or in combination):\r\ncorticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressive and immunomodulator therapy(i.e.,azathioprine,mycophenolate ,cyclophosphamide,methotrexate,Tacrolimus ,ciclosporin )"},{"intervention_type":"Biological","name":"Biological: RC18 160 mg plus standard therapy","description":"Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressive and immunomodulator herapy(i.e.,azathioprine,mycophenolate ,cyclophosphamide,methotrexate,Tacrolimus ,ciclosporin )"}],"outcomes":[{"outcome_type":"primary","measure":"SLE Responder Index (SRI) Response Rate","time_frame":"Week 52","description":"At Week 52 the percent of subjects with ≥ 4 point reduction from baseline in SELENA-SLEDAI score and increasing no more than 0.3 points in PGA and no new BILAG A organ domain score or 1 new BILAG B organ domain scores compared with baseline at the time of assessment"},{"outcome_type":"secondary","measure":"Percent of subjects with ≥ 4 point reduction from baseline in SELENA-SLEDAI score","time_frame":"Week 52"},{"outcome_type":"secondary","measure":"Mean Change From Baseline in Physician's global assessment(PGA)","time_frame":"Week 52","description":"Physician's global assessment, PGA.The measurement tool is Visual Analogue Scale/Score（VAS）.The doctor assesses participant's disease activity on a VAS of 0-100 mm on the questionnaire form.The higher values represent a worse outcome.There are not combined subscales."},{"outcome_type":"secondary","measure":"Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline or ≤ 7.5 mg/Day，During Weeks 44 Through 52.","time_frame":"Week 44 through 52"},{"outcome_type":"secondary","measure":"Mean Change From Baseline in Serological Examination Index","time_frame":"week 52"},{"outcome_type":"secondary","measure":"The flare time after randomization","time_frame":"52 weeks"}]}
{"nct_id":"NCT04097158","start_date":"2019-10-08","enrollment":160,"brief_title":"Biomarkers in Different Types of Amyotrophic Lateral Sclerosis (ALS) Patients Being Treated With Edaravone","official_title":"Oxidative Markers and Efficacy in Amyotrophic Lateral Sclerosis (ALS) Phenotypes Treated With Edaravone","primary_completion_date":"2021-09-30","study_type":"Observational","rec_status":"Recruiting","completion_date":"2021-09-30","last_update":"2021-04-12","description":"This study is being conducted to help the investigators better understand how the new FDA approved medication Edaravone (also known as Radicava) works in subsets of patients with ALS. The investigators are also trying to understand if there are specific ALS patients, with different presentations of ALS, who might benefit most from this medication. Also, the investigators are following specific biomarkers to determine the optimal treatment duration in patients with different forms of ALS There is no study medication being offered in this trial. Edaravone is prescribed as part of regular care. In this trial we are collecting blood, urine, and spinal fluid samples in ALS patients who are taking Edaravone and ALS patients who are not taking Edaravone to measure certain markers that could indicate why the drug may be working in a specific type of ALS.","other_id":"IRB#5190061","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":85,"population":"Anyone who meets the Inclusion/Exclusion Criteria","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Either possible, probable, or definite ALS, predominantly lower motor neuron disease,\r\n             predominantly upper motor neuron disease, or bulbar\r\n\r\n          2. With or without cognitive involvement\r\n\r\n          3. Willing to participate\r\n\r\n          4. On no experimental treatment\r\n\r\n          5. Ages 18 - 85\r\n\r\n          6. No prior exposure to Edaravone (Radicava)\r\n\r\n          7. On a stable dose of Riluzole for 30 days or off Riluzole\r\n\r\n          8. Male or female\r\n\r\n          9. Females of childbearing age must use contraception\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Unstable medical illness\r\n\r\n          2. Abnormal liver function (>2x ULN)\r\n\r\n          3. Unlikely to survive for 26 weeks\r\n      ","sponsor":"Loma Linda University","sponsor_type":"Other","conditions":"Amyotrophic Lateral Sclerosis","interventions":[{"intervention_type":"Other","name":"Other: Sample Collection","description":"The investigators will be collecting blood, urine, and spinal fluid samples."}],"outcomes":[{"outcome_type":"primary","measure":"Define pharmacodynamic biomarkers of oxidative stress and antioxidant capacity in different ALS/MND phenotypes.","time_frame":"6 months","description":"The investigators aim to identify 4 cohorts of patients with distinct ALS/MND phenotypes and measure a panel of pharmacodynamic biomarkers of oxidative stress and antioxidant capacity in the CSF, blood, and urine."}]}
{"nct_id":"NCT04034719","start_date":"2019-10-08","phase":"N/A","enrollment":80,"brief_title":"Benefit of Scarf Support on Skin-to-skin Time and Portage in Neonatology and at Home","official_title":"Benefit of Scarf Support on Skin-to-skin Time and Portage in Neonatology and at Home(PAPSE)","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-12-31","last_update":"2021-01-29","description":"Carrying (or kangaroo carrying) is known to reduce neonatal and child morbidity and mortality and improves the quality of survival of premature and term children during the most fragile growth period, the first thousand days of life. Carrying is also a growing brain protection technique and becomes a routine of care in all neonatal units around the world. In University hospital of Saint-Etienne, the developmental care program has been developed since 2002 in all neonatology units and advocates the practice of skin-to-skin carrying between the parent (father or mother) and his baby, from the time of the hospitalization. Professionals in units who have long been thinking about the concept of attachment and the benefits of skin-to-skin, wish to validate the use of the wearing scarf as a tool for the practice of skin -in-skin in neonatology then back home by performing a randomized monocentric prospective longitudinal study.","other_id":"19CH089","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","maximum_age":0.19231,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        For the child:\r\n\r\n          -  Any newborn regardless of gestational age and postnatal age hospitalized in the\r\n             neonatology department of the University Hospital of Saint-Etienne\r\n\r\n        For the parent (father or mother):\r\n\r\n          -  Be a parent of a child eligible for the research protocol\r\n\r\n        Exclusion Criteria:\r\n\r\n        For the child:\r\n\r\n          -  Need for sedation or analgesia for the duration of the study\r\n\r\n          -  Orthopedic pathology incompatible with the practice of carrying\r\n\r\n          -  Other medical contraindications to carriage\r\n\r\n          -  Absence of parents\r\n\r\n        For the parent (father or mother):\r\n\r\n          -  Family, social or psychological situation compromising the evaluation\r\n\r\n          -  No fluency in the French language\r\n      ","sponsor":"Centre Hospitalier Universitaire de Saint Etienne","sponsor_type":"Other","conditions":"Infant, Newborn, Disease","interventions":[{"intervention_type":"Other","name":"Other: portage scarf","description":"Parents will be carried their newborn with the portage scarf provided by the department."},{"intervention_type":"Other","name":"Other: usual practice","description":"Parents will be carried their newborn as their usual practice."}],"outcomes":[{"outcome_type":"primary","measure":"Number of minuts with portage skin-to-skin","time_frame":"From inclusion to 2 months after exit","description":"Measured in minutes by the time sheet of presence."}]}
{"nct_id":"NCT04257721","start_date":"2019-10-07","enrollment":120,"brief_title":"Predictive Score For Maxillary Osteonecrosis After Invasive Oral Surgery","official_title":"Development Of A Predictive Score For Maxillary Osteochimionecrosis After Invasive Oral Surgery In Patients Treated Whith Biphosphonates Or Biotherapies: The PREV-ONM Study","primary_completion_date":"2022-10-10","study_type":"Observational","rec_status":"Recruiting","completion_date":"2023-01-10","last_update":"2021-05-12","description":"Non-interventional prospective multicentre cohort study to determine a predictive score for the occurrence of osteochimionecrosis of the jaws after invasive oral surgery in patients who have received biphosphonates or antangiogenic drugs as part of chemotherapy with malignant bone disease (multiple myeloma or bone metastasis of a solid tumour). Data are collected during the usual follow-up of patients during the first 3 months following surgery.","other_id":"2019-A01495-52","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"patients who have received biphosphonates or antangiogenic drugs as part of chemotherapy\r\n        with malignant bone disease (multiple myeloma or bone metastasis of a solid tumour) and who\r\n        has had an oral surgical procedure (single or multiple dental extraction, with or without\r\n        alveolectomy, under local or general anesthesia)","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  patients who have received at least one of the following molecules as part of\r\n             chemotherapy with malignant bone disease (multiple myeloma or bone metastasis of a\r\n             solid tumour):\r\n\r\n          -  Biphosphonates: ZOLEDRONATE (ZOMETA), PAMIDRONATE (AREDIA, OSTEPAM)\r\n\r\n          -  Anti-angiogenic: DENOSUMAB (XGEVA), BEVACIZUMAB (AVASTIN), RITUXIMAB (MABTHERA,\r\n             RIXATHON, TRUXIMA), SUNITINIB (SUTENT), PAZOPANIB (VOTRIENT), AXITINIB (INLYTA),\r\n             CARBOZANTINIB (CABOMETYX, COMETRIQ), SORAFENIB (NEXAVAR)\r\n\r\n          -  Patient who has had an oral surgical procedure (single or multiple dental extraction,\r\n             with or without alveolectomy, under local or general anesthesia)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of oral and/or cervico-facial radiotherapy\r\n\r\n          -  Patient treated successively with biphosphonates and then with anti-angiogenic drugs.\r\n\r\n          -  Patient under guardianship, curatorship, or imprisonment\r\n\r\n          -  Patient who has notified his refusal to participate in the research\r\n      ","sponsor":"Centre Hospitalier Sud Francilien","sponsor_type":"Other","conditions":"Osteonecrosis Due to Drugs, Jaw","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"occurrence of osteonecrosis of the jaw","time_frame":"within 3 months after surgery","description":"occurrence of osteonecrosis of the jaw"},{"outcome_type":"secondary","measure":"Frequency of post-operative healing (bone and gingival) and comparison to each patient's UCONNS score.","time_frame":"within 3 months after surgery","description":"Frequency of post-operative healing (bone and gingival) and comparison to each patient's UCONNS score.\r\nThe UCONNS score was proposed in 2011. Its objective is to be able to predict the occurrence of osteochimionecrosis in conjunction with biphosphonate treatment before a dental invasive procedure (dental avulsions, implant placement, etc.). It takes into account several types of variables:\r\nThe patient's general condition and comorbidities (HIV, osteoporosis, rheumatoid arthritis, diabetes, presence or not of a soft tissue tumour, presence or not of a breast or prostate tumour, multiple myeloma, ...)\r\nThe nature, dose, and duration of use of the biphosphonate received\r\nOral hygiene\r\npresence of suppuration, presence of osteomyelitis\r\nThe dental surgery received (endodontic treatment, periodontal treatment, surgery muco-gingival, tooth extraction, apical surgery, bone resection)"}]}
{"nct_id":"NCT04023084","start_date":"2019-10-03","phase":"Phase 4","enrollment":30,"brief_title":"Response of Children With Atopic Dermatitis (Eczema) to Eucrisa","official_title":"PDE4A Expression as a Biomarker of Responsiveness to Eucrisa","primary_completion_date":"2021-07-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-07-31","last_update":"2021-08-02","description":"The purpose of this study is to develop biomarkers to predict what medication is best for each child with atopic dermatitis (eczema). Participants will come in to Lurie Children's Allergy of Dermatology clinic for a skin examination and complete surveys. They will apply Eucrisa medication to their skin for 28 days before returning for a second and final skin examination and complete surveys. During these skin exams, tape will be placed on the skin and removed to collect skin cell samples. Photos will also be taken of the skin where tape was placed. There is an optional blood draw.","other_id":"2019-2879","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","intervention_model_description":"children diagnosed with AD and aged 4 months-17 years old will receive intervention","sampling_method":"","gender":"All","minimum_age":0.33333,"maximum_age":17,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  AD diagnosis by dermatologist or allergist based on Hanifin and Rajka criteria\r\n\r\n          -  5% or more treatable body surface area involvement\r\n\r\n          -  baseline Investigator's Static Assessment (ISGA) score of mild (2) or moderate (3)\r\n\r\n          -  patient on stable regimens (consistent use 14 days before day 1 of enrollment) of\r\n             inhaled corticosteroids and antihistamines\r\n\r\n          -  must have lesional skin in the antecubital fossa\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  use of topical corticosteroid, calcineurin inhibitor, or PDE4 inhibitor within 14 days\r\n             of enrollment\r\n\r\n          -  significant active infection\r\n\r\n          -  any previous use of biologic therapy\r\n\r\n          -  no pruritus at baseline visit, or other pruritic condition\r\n\r\n          -  washing/moisturizer use 24 hours prior to tape strip biomarker collection at site\r\n\r\n          -  uncontrolled asthma, uncontrolled allergic rhinitis, or other sleep disturbing\r\n             condition\r\n      ","sponsor":"Ann & Robert H Lurie Children's Hospital of Chicago","sponsor_type":"Other","conditions":"Atopic Dermatitis|Eczema","interventions":[{"intervention_type":"Drug","name":"Drug: Crisaborole","description":"Crisaborole 2% topical ointment applied twice daily to affected area(s) for 28 days"}],"outcomes":[{"outcome_type":"primary","measure":"Changes in expression levels of biomarkers in responder versus non responder groups","time_frame":"Baseline (Day 1) and Day 28","description":"The baseline mean expression levels of biomarkers extracted from tape strips (TH2 (IL13, IL4R, CCL26), TH17/22 (IL36G), itch (ENKUR), epidermal genes (FLG, LOR and S100A9) and PDE4A will be compared in clinical \"responder\" versus \"non-responder\" groups. Groups will be defined by the primary clinical outcome of disease severity improvement by clinician assessment. Clinicians will assess disease severity by Investigator's Static Global Assessment (ISGA) and Eczema Area and Severity Index (EASI) score."},{"outcome_type":"secondary","measure":"Changes in Quality of life (anxiety, depressive symptoms, fatigue, mobility, pain interference, peer relationships) as assessed by PROMIS Pediatric Profile 25 and Correlation of changes with clinical responsiveness and biomarker PDE4A expression levels","time_frame":"Baseline (Day 1) and Day 28","description":"Changes in quality of life will be measured by comparing standardized PROMIS T-scores for each domain at Day 28 with baseline. The PROMIS Pediatric Profile 25 is a 25-item questionnaire and assesses anxiety, depressive symptoms, fatigue, mobility, pain interference, and peer relationships. Each item has five response options. The HealthMeasures Scoring Service will be used to calculate T-scores for each domain. A T-score of 50 is the average for the United States general population with a standard deviation of 10. A higher T-score represents more of the concept being measured. Responsiveness will be determined by comparing clinician-assessed disease severity by ISGA and EASI scores at baseline and Day 28."},{"outcome_type":"secondary","measure":"Changes in Quality of life (symptoms and feelings, leisure, school or holidays, personal relationships, sleep, treatment) as assessed by CDLQI and Correlation of Quality of life changes with clinical responsiveness and biomarker PDE4A expression levels","time_frame":"Baseline (Day 1) and Day 28","description":"Changes in quality of life will be measured by comparing CDLQI scores at Day 28 with baseline. The CDLQI is a 10-item questionnaire assessing symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and treatment. Scores range from 0 to 30 and are calculated by summing the scores of each question. The higher the score, the more impaired quality of life. Responsiveness will be determined by comparing ISGA and EASI scores at baseline and Day 28."},{"outcome_type":"secondary","measure":"Correlation of TEWL with clinical responsiveness and biomarker PDE4A expression levels","time_frame":"Baseline (Day 1) and Day 28","description":"Diffusion of water through the skin is measured using the AquaFlux instrument. Responsiveness will be determined by comparing ISGA and EASI scores at baseline and Day 28."}]}
{"nct_id":"NCT04108065","start_date":"2019-10-02","enrollment":30,"brief_title":"The Role of Pregnancy-induced Gallbladder Dysmotility in the Pathophysiology of Gestational Diabetes Mellitus","official_title":"The Role of Pregnancy-induced Gallbladder Dysmotility in the Pathophysiology of Gestational Diabetes Mellitus","primary_completion_date":"2020-10-30","study_type":"Observational","rec_status":"Completed","completion_date":"2020-10-30","last_update":"2020-12-21","description":"The primary aim of the study is to evaluate postprandial gallbladder emptying and plasma concentrations of the glucose-lowering and satiety-promoting gut hormone glucagon-like peptide 1 (GLP-1) during third trimester of pregnancy in women with gestational diabetes mellitus (GDM) compared with age and body mass index (BMI)-matched pregnant control women with normal glucose tolerance (NGT).","other_id":"H-19036095","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"Female","minimum_age":18,"population":"Fifteen women with gestational diabetes mellitus and 15 age and body mass index\r\n        (BMI)-matched pregnant women with normal glucose tolerance will be enrolled in the study.\r\n        Only pregnant women who have been tested for gestational diabetes mellitus will be enrolled\r\n        in the study.","criteria":"\n        Inclusion criteria - women with gestational diabetes mellitus (GDM):\r\n\r\n          -  GDM diagnosed according to current Danish guidelines (plasma glucose (PG)\r\n             concentration at 120 min after a 75 g oral glucose tolerance test (OGTT) 9.0 mM)\r\n\r\n          -  Caucasian ethnicity\r\n\r\n          -  Age >18 years\r\n\r\n          -  Pre-pregnancy BMI <30 kg/m2 and third trimester BMI <35 kg/m2\r\n\r\n          -  Informed oral and written consent\r\n\r\n        Exclusion criteria - women with gestational diabetes:\r\n\r\n          -  Anaemia (haemoglobin <7.5 mM)\r\n\r\n          -  Previous preeclampsia, HELLP syndrome (haemolysis, elevated liver enzymes and low\r\n             platelets) and/or pregnancy-induced intrahepatic cholestasis\r\n\r\n          -  Gastrointestinal disease, previous gastric or intestinal resection, cholecystectomy\r\n             and/or any major intra-abdominal surgery\r\n\r\n          -  Previous pancreatic disease and/or neoplasia\r\n\r\n          -  Postpartum use of hormonal contraception including intrauterine device\r\n\r\n          -  Any condition the investigator group suspect would interfere with trial participation\r\n\r\n        Inclusion criteria - control group:\r\n\r\n          -  Normal glucose tolerance (fasting plasma glucose (PG) concentration 6.0 mM and PG\r\n             concentration at 120 min after a 75 g-OGTT <7.8 mM)\r\n\r\n          -  Caucasian ethnicity\r\n\r\n          -  Age >18 years\r\n\r\n          -  Pre-pregnancy BMI <30 kg/m2 and third trimester BMI <35 kg/m2\r\n\r\n          -  Informed oral and written consent\r\n\r\n        Exclusion criteria - control group:\r\n\r\n          -  Anaemia (haemoglobin <7.5 mM)\r\n\r\n          -  Previous preeclampsia, HELLP syndrome (haemolysis, elevated liver enzymes and low\r\n             platelets) and/or pregnancy induced intrahepatic cholestasis\r\n\r\n          -  Gastrointestinal disease, previous gastric or intestinal resection, cholecystectomy\r\n             and/or any major intra-abdominal surgery\r\n\r\n          -  Previous pancreatic disease and/or neoplasia\r\n\r\n          -  Postpartum use of hormonal contraception including intrauterine device\r\n\r\n          -  Verified prior GDM\r\n      ","sponsor":"University Hospital, Gentofte, Copenhagen","sponsor_type":"Other","conditions":"Gestational Diabetes Mellitus","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"GLP-1 response","time_frame":"240 minutes","description":"Postprandial GLP-1 response (as assessed by area under curve (AUC) within 240 minutes after meal ingestion) during third trimester compared to 3-9 months postpartum."},{"outcome_type":"primary","measure":"Gallbladder emptying","time_frame":"240 minutes","description":"Postprandial gallbladder emptying (evaluated as repeated measures of gallbladder volumes using bed-side ultrasonography within 240 minutes after meal ingestion) during third trimester compared to 3-9 months postpartum."},{"outcome_type":"secondary","measure":"Responses of glucose, insulin, C-peptide, glucagon, GIP","time_frame":"240 minutes","description":"Postprandial responses of glucose, insulin, C-peptide, glucagon (as assessed by area under curve (AUC) during third trimester compared to 3-9 months postpartum."},{"outcome_type":"secondary","measure":"Gastric emptying","time_frame":"240 minutes","description":"Postprandial responses of paracetamol (as assessed by area under curve (AUC) during third trimester compared to 3-9 months postpartum."},{"outcome_type":"secondary","measure":"Bile acid and gallbladder physiology","time_frame":"240 minutes","description":"Postprandial responses of GLP-2, CCK, total bile acids, C4 and FGF-19 (as assessed by area under curve (AUC) during third trimester compared to 3-9 months postpartum."},{"outcome_type":"secondary","measure":"Oxytocin","time_frame":"240 minutes","description":"Postprandial responses of oxytocin (as assessed by area under curve (AUC) during third trimester compared to 3-9 months postpartum."},{"outcome_type":"secondary","measure":"GDF15","time_frame":"240 minutes","description":"Postprandial responses of GDF-15 (as assessed by area under curve (AUC) during third trimester compared to 3-9 months postpartum."}]}
{"nct_id":"NCT04093804","start_date":"2019-10-01","phase":"N/A","enrollment":120,"brief_title":"Impact of Glenosphere Size on Range of Motion in Female Patients Undergoing Reverse Shoulder Arthroplasty","official_title":"Impact of Glenosphere Size on Range of Motion in Female Patients Undergoing Reverse Shoulder Arthroplasty","primary_completion_date":"2022-10-01","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2024-09-01","last_update":"2019-09-18","description":"The purpose of this study is to perform a prospective randomized trial among female patients undergoing reverse shoulder arthroplasty (RSA) to determine if a larger glenosphere allows greater range of motion without an impact on complications.","other_id":"TOH183","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","intervention_model_description":"This study is a randomized trial consisting of female patients undergoing reverse shoulder arthroplasty for rotator cuff tear arthropathy or a massive irreparable rotator cuff tear. The experimental group will receive a 36mm glenosphere and the control group will receive the standard 32mm glenosphere. All other conditions of the surgical procedure will be identical as well as the clinical follow-up.","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Female sex\r\n\r\n          -  Diagnosis of rotator cuff tear arthropathy or a massive irreparable rotator cuff tear\r\n             for which the patient has elected to undergo reverse shoulder arthroplasty\r\n\r\n          -  No history of prior shoulder arthroplasty\r\n\r\n          -  Consent to study participation by signing the informed consent and the Protected\r\n             Health Information (PHI) form (Attachment B and C)\r\n\r\n          -  Ability to speak, read and write English\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Male sex\r\n\r\n          -  Any impairment that would prevent answering the surveys\r\n\r\n          -  No children or adolescents under the age of 18 years old\r\n\r\n          -  No prisoners, pregnant women, or mentally disabled persons\r\n\r\n          -  No Workers' Compensation cases\r\n      ","sponsor":"Fondren Orthopedic Group L.L.P.","sponsor_type":"Other","conditions":"Rotator Cuff Tear Arthropathy|Massive Irreparable Rotator Cuff Tear","interventions":[{"intervention_type":"Device","name":"Device: Glenosphere size for Reverse Shoulder Arthroplasty","description":"Two randomized study groups will be formed with the consented patients (experimental and control). All patients will undergo reverse shoulder arthroplasty by the Principal Investigator. The experimental group patients will receive a 36mm glenosphere and the control group will receive a 32mm glenosphere. All other procedures during the surgery are identical between groups."}],"outcomes":[{"outcome_type":"primary","measure":"Active range of motion","time_frame":"Change from baseline (pre-operative) to 2 years follow-up","description":"Shoulder elevation, abduction, external rotation in abduction, and internal rotation"},{"outcome_type":"primary","measure":"Passive range of motion","time_frame":"Change from baseline (pre-operative) to 2 years follow-up","description":"Shoulder elevation and external rotation"},{"outcome_type":"secondary","measure":"American Shoulder and Elbow Surgeon (ASES) Shoulder Index","time_frame":"Change from baseline (pre-operative) to 2 years follow-up","description":"Standard functional outcomes questionnaire following shoulder surgery, range 0 - 100 (highest function)"},{"outcome_type":"secondary","measure":"Constant-Murley Shoulder Outcome score","time_frame":"Change from baseline (pre-operative) to 2 years follow-up","description":"Standard functional outcomes questionnaire following shoulder surgery, range 0 - 100 (highest function)"}]}
{"nct_id":"NCT04417413","start_date":"2019-10-01","enrollment":41,"brief_title":"Safety and Efficacy of Non-ablative Er:YAG Laser Therapy for the Treatment of Pelvic Organ Prolapse and Coexisting Stress Urinary Incontinence: A Retrospective Case Series.","official_title":"Safety and Efficacy of Non-ablative Er:YAG Laser Therapy for the Treatment of Pelvic Organ Prolapse and Coexisting Stress Urinary Incontinence: A Retrospective Case Series.","primary_completion_date":"2019-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2019-12-31","last_update":"2020-11-13","description":"The objective of the study is to retrospectively collect the data on patients who underwent pelvic organ prolapse treatment using a non-ablative Er:YAG laser with SMOOTH mode and to conduct an objective evaluation of safety and efficacy of Er:YAG laser treatment. In a group of patients that have concomitant stress urinary incontinence symptoms, the effectiveness of the treatments on these symptoms will be evaluated as well.","other_id":"POP+SUI","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"Female","minimum_age":18,"population":"All patients that had pelvic organ prolapse with or without concomitant stress urinary\r\n        incontinence and that were treated using non-ablative Fotona Er:YAG laser (ProlapLase\r\n        treatment) in the time period from 2015 to 2016 were included in this retrospective study.","criteria":"\n        Inclusion Criteria:\r\n\r\n        All patients that had pelvic organ prolapse with or without concomitant stress urinary\r\n        incontinence and that were treated using non-ablative Fotona Er:YAG laser (ProlapLase\r\n        treatment) in the time period from 2015 to 2016 will be included in this retrospective\r\n        study.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Patients who failed to attend a follow-up appointment will be excluded from this\r\n        retrospective case series study.\r\n      ","sponsor":"Aleksandra Novakov Mikic","sponsor_type":"Other","conditions":"Cystocele|Pelvic Organ Prolapse|Stress Urinary Incontinence","interventions":[{"intervention_type":"Device","name":"Device: Fotona ProlapLase","description":"Non-ablative SMOOTH mode intravaginal Er:YAG teratment for pelvic organ prolapse"}],"outcomes":[{"outcome_type":"primary","measure":"Cystocele stage","time_frame":"Before and at all follow ups (up to 3 months after last treatment)","description":"Assesment of POP grade using Baden-Walker scale"},{"outcome_type":"primary","measure":"Severity of stress urinary incontinence","time_frame":"Before and at all follow ups (up to 3 months after last treatment)","description":"assessment of SUI severity using ICIQ-UI questionnaire"},{"outcome_type":"secondary","measure":"Assesment of safety","time_frame":"Before and at all follow ups (up to 3 months after last treatment)","description":"Assesment of adverse effects"},{"outcome_type":"secondary","measure":"Patient satisfaction","time_frame":"Before and at all follow ups (up to 3 months after last treatment)","description":"Assesment of patient satisfaction using 0-10 VAS scale"}]}
{"nct_id":"NCT03975075","start_date":"2019-10-01","phase":"N/A","enrollment":30,"brief_title":"Biofeedback Treatment of Anxiety Associated With Chronic Spinal Cord Injury","official_title":"Biofeedback Treatment of Anxiety Associated With Chronic Spinal Cord Injury","primary_completion_date":"2022-04-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-04-30","last_update":"2021-06-14","description":"The purpose of this research is to test the feasibility of an intervention using biofeedback to treat stress and anxiety among individuals with tetraplegia. The expected duration of participation in this study is about 15 hours over the course of about 5 weeks. Participants will be randomly assigned to either a biofeedback training intervention or a control group. After completing questionnaires, participants will undergo physiological monitoring (measuring heart rate and breathing) at Craig Hospital. Those assigned to the biofeedback group will undergo 30 minutes of physiological monitoring while also participating in biofeedback training twice a week for 4 weeks (8 sessions) from home. Those assigned to the control group will undergo 30 minutes of physiological monitoring twice a week for 4 weeks (8 sessions) from home, but will not receive biofeedback training. Each session is expected to last 1-1.5 hours. Following each training session, participants will respond to questionnaires over the phone. It is hypothesized that the biofeedback intervention will demonstrate high feasibility and compared to those in the control group, participants who receive the biofeedback intervention will attain greater pre-post reductions in both physiological and self-reported stress.","other_id":"594559","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age 18 to 65\r\n\r\n          -  Diagnosis of tetraplegia with residual sensory or motor impairments\r\n\r\n          -  Discharged from inpatient rehabilitation and living in the community\r\n\r\n          -  Access to high-speed internet at home\r\n\r\n          -  Willingness to download the videoconferencing software Zoom\r\n\r\n          -  Access to a mobile phone and willingness to download HRV software\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Does not speak English\r\n\r\n          -  Scores less than 37 on the STAI\r\n\r\n          -  Unable to travel to Craig for an initial assessment\r\n\r\n          -  History of participating in biofeedback training\r\n\r\n          -  Requires mechanical ventilation\r\n\r\n          -  Dependent on diaphragm pacer for respiration\r\n\r\n          -  Currently in treatment for anxiety (e.g., pharmacologic or psychotherapeutic)\r\n\r\n          -  Associated medical condition for which biofeedback is contraindicated (e.g.,\r\n             psychosis, pacemaker, or other implantable electric device)\r\n\r\n          -  Currently hospitalized for medical/rehabilitation treatment\r\n\r\n          -  Unable to commit to the four-week intervention\r\n      ","sponsor":"Craig Hospital","sponsor_type":"Other","conditions":"Spinal Cord Injuries|Anxiety|Stress|Tetraplegia","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Psychophysiological monitoring","description":"30 minutes of one channel (ECG) physiological monitoring with Mindfield eSense Pulse."},{"intervention_type":"Behavioral","name":"Behavioral: Biofeedback training","description":"Traditional resonance frequency training with the Mindfield eSense Pulse smartphone application. Using visual feedback of real time parameters of HRV and the use of controlled breathing, participants are trained to reach a relaxed state."}],"outcomes":[{"outcome_type":"primary","measure":"Change in physiological stress","time_frame":"Session #1 (week 1) and Session #8 (week 4)","description":"Average LF (ms2)"},{"outcome_type":"primary","measure":"Change in Depression Anxiety Stress Scale-21 (DASS-21) scores","time_frame":"Baseline (week 0) and Session #8 (week 4)","description":"The Depression Anxiety Stress Scale-21 (DASS-21) is a self report instrument designed to measure core symptoms of depression, anxiety, and stress. Each of the three DASS-21 scales contains seven items, divided into subscales with similar content. Scores for depression, anxiety, and stress are calculated by summing the scores for the relevant items. Items are rated on a scale from 0 (did not apply to me at all) to 3 (applied to me very much or most of time), with higher scores indicating more depression, anxiety, and stress."},{"outcome_type":"primary","measure":"Change in Subjective Units of Distress Scale (SUDS) scores","time_frame":"Baseline (week 0) and Session #8 (week 4)","description":"The Subjective Units of Distress Scale (SUDS) is a single-item self report instrument designed to measure the intensity of feelings and other internal experiences such as anxiety, anger, agitation, stress, or other painful feelings. A scale of 0 to 100 will be used to measure the subjective intensity of disturbance or distress experienced by the participant. A higher score indicates greater distress."},{"outcome_type":"secondary","measure":"Symptom list","time_frame":"After intervention session #1 (week 1), before and after intervention sessions #2-8 (weeks 1 through 4)","description":"A list of self-reported symptoms will be used to track any new symptoms requiring medical attention that emerge during the course of the study."},{"outcome_type":"secondary","measure":"State Trait Anxiety Inventory (STAI)","time_frame":"After intervention sessions #1-8 (weeks 1 through 4)","description":"The State Trait Anxiety Inventory (STAI) is a 40 item self-report inventory consisting of 20 items to assess trait anxiety and 20 items to assess state anxiety. Items are rated on a scale from 1 (not at all) to 4 (very much). A total score is calculated by summing all six scores, multiplying the sum by 20, and then dividing by six. Total scores range from 20 - 80 with higher scores indicating greater self-reported anxiety. A normal score on the STAI is 34 - 36."},{"outcome_type":"other","measure":"Brief Pain Inventory (BPI) - 4 pain severity items","time_frame":"Baseline (week 0) and Session #8 (week 4)","description":"The Brief Pain Inventory (BPI) is one of the most widely used tools to assess pain. For this study, the four pain severity items will be used to assess worst, least, average, and current pain."},{"outcome_type":"other","measure":"Brief Pain Inventory (BPI) - current pain severity item","time_frame":"Before and after intervention Sessions #1-7 (weeks 1 - 3)","description":"A single item from the Brief Pain Inventory (BPI) will be used to assess the severity of current pain."},{"outcome_type":"other","measure":"Brief Pain Inventory (BPI) - pain relief item","time_frame":"After each intervention Session #1-8 (weeks 1 - 4)","description":"A single item from the Brief Pain Inventory (BPI) has been modified from, \"In the last 24 hours, how much relief have pain treatments or medications provided? Please mark the box below the percentage that most shows how much relief you have received\" to read, \"During this session, how much pain relief did you experience? Please indicate the percentage that best describes how much relief you received.\""},{"outcome_type":"other","measure":"Impact of study participation","time_frame":"Session #8 (week 4)","description":"Impact of Study Participation is a single open-ended item used to determine if study participation impacted anything other than stress, anxiety, or pain. Following the final session, participants will be asked, \"Are there conditions other than stress, anxiety, or pain that were impacted by your participation in this study? If so, please list.\""}]}
{"nct_id":"NCT04089371","start_date":"2019-10-01","enrollment":80,"brief_title":"A Post-Market Clinical Evaluation of the ReUnion Reversible Fracture (RFX) System","official_title":"A Post-Market Clinical Evaluation of the ReUnion Reversible Fracture (RFX) System","primary_completion_date":"2029-06-30","study_type":"Observational","rec_status":"Recruiting","completion_date":"2029-09-30","last_update":"2021-06-01","description":"This investigation is a prospective, multi-center clinical investigation. It is anticipated that a total of one hundred (100) subjects will be enrolled at approximately 5-10 sites. The clinical investigation has been designed to follow the surgeon's standard of care for joint arthroplasty patients, which entails clinical evaluation on a regular ongoing basis, or as needed should the patient become symptomatic in the treated joint.","other_id":"ReUnion RFX Study","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":80,"population":"Subjects participating in this clinical investigation will be recruited from the\r\n        investigator's standard patient population, where patients will be evaluated for clinical\r\n        investigation participation based on the eligibility criteria.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subject is willing to sign the informed consent.\r\n\r\n          -  Subject is willing and able to comply with postoperative scheduled clinical\r\n             evaluations.\r\n\r\n          -  Subject is male or non-pregnant female and 18 years or older at the time of surgery.\r\n\r\n          -  When used with ReUnion Total Shoulder Arthroplasty (TSA)Humeral & Glenoid components\r\n             as a Hemiarthroplasty or Total Shoulder Replacement, subject has one or more of the\r\n             following:\r\n\r\n               -  Aseptic necrosis of humeral head;\r\n\r\n               -  Painful, disabling joint disease of the shoulder resulting from degenerative\r\n                  arthritis, rheumatoid arthritis or post-traumatic arthritis;\r\n\r\n               -  Proximal humeral fracture and/or dislocation;\r\n\r\n               -  Clinical management problems where arthrodesis or alternative reconstructive\r\n                  techniques are less likely to achieve satisfactory results;\r\n\r\n               -  Previous unsuccessful total shoulder replacement, resurfacing or other procedure\r\n\r\n          -  When used with ReUnion RSA Humeral & Glenoid Components as a primary, fracture or\r\n             revision total shoulder replacement, subject's joint has gross rotator cuff\r\n             deficiency, a functional deltoid muscle and is anatomically and structurally suited to\r\n             receive the implant, and subject has one or more of the following:\r\n\r\n               -  Painful, disabling joint disease of the shoulder resulting from degenerative\r\n                  arthritis or rheumatoid arthritis;\r\n\r\n               -  Proximal humeral fracture\r\n\r\n               -  Previously failed shoulder joint replacement\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subject has an active or suspected latent infection in or about the shoulder joint.\r\n\r\n          -  Subject has mental or neuromuscular disorder which would create an unacceptable risk\r\n             of prosthesis instability, prosthesis fixation failure or complications in\r\n             postoperative care.\r\n\r\n          -  Subject has bone stock compromised by disease, infection or prior implantation which\r\n             cannot provide adequate support and/or fixation to the prosthesis.\r\n\r\n          -  Subject has anticipated activities which would impose high stresses on the prosthesis\r\n             and its fixation.\r\n\r\n          -  Subject is obese such that he/she produces a load on the prosthesis which can lead to\r\n             failure of fixation of the device or to failure of the device itself.\r\n\r\n          -  Subject has severe concomitant disease(s)which may significantly affect the clinical\r\n             outcome.\r\n\r\n          -  For Total Shoulder Arthroplasty and Hemiarthroplasty: Subject has absent, irreparable\r\n             or non-functioning rotator cuff and other essential muscles\r\n      ","sponsor":"Stryker Trauma GmbH","sponsor_type":"Industry","conditions":"Arthroplasty|Hemiarthroplasty|Shoulder Pain","interventions":[{"intervention_type":"Device","name":"Device: ReUnion Total Shoulder Arthroplasty (TSA)","description":"The ReUnion RFX System includes a Reversible Fracture Stem (RFX Stem) that can utilize either the ReUnion Total Shoulder Arthroplasty (TSA) or ReUnion Reverse Shoulder Arthroplasty (RSA) humeral and glenoid components and is indicated for use as a hemi, total or reverse shoulder replacement. The ReUnion RFX stem is intended for cemented use only."},{"intervention_type":"Device","name":"Device: ReUnion Reverse Shoulder Arthroplasty (RSA)","description":"The ReUnion RFX System includes a Reversible Fracture Stem (RFX Stem) that can utilize either the ReUnion Total Shoulder Arthroplasty (TSA) or ReUnion Reverse Shoulder Arthroplasty (RSA) humeral and glenoid components and is indicated for use as a hemi, total or reverse shoulder replacement. The ReUnion RFX stem is intended for cemented use only."}],"outcomes":[{"outcome_type":"primary","measure":"24-month mean ASES shoulder score: Arm A (Total Shoulder Arthoplasty/Hemiarthroplasty)","time_frame":"24 months","description":"This is a mixed outcome reporting measure, applicable for use in patients with shoulder pathology regardless of diagnosis and consists of a pain visual analog scale (VAS) and 10 functional questions. The primary endpoint of the clinical investigation is to demonstrate non-inferiority of the device to the selected literature controls, as measured by the ASES Shoulder Score at 24 Months post-operative."},{"outcome_type":"primary","measure":"24-month mean ASES shoulder score: Arm B (Reverse Shoulder Arthroplasty)","time_frame":"24 months","description":"This is a mixed outcome reporting measure, applicable for use in patients with shoulder pathology regardless of diagnosis and consists of a pain visual analog scale (VAS) and 10 functional questions. The primary endpoint of the clinical investigation is to demonstrate non-inferiority of the device to the selected literature controls, as measured by the ASES Shoulder Score at 24 Months post-operative."},{"outcome_type":"secondary","measure":"Device-related adverse events","time_frame":"10 years","description":"Incidence of intraoperative and post-operative adverse events related to the device will be collected and reported. Time to earliest device-related incident will be analyzed."},{"outcome_type":"secondary","measure":"Implant survivorship","time_frame":"10 years","description":"Time to mortality or last available assessment will be measured and reported."}]}
{"nct_id":"NCT04253015","start_date":"2019-09-30","enrollment":125,"brief_title":"A Post-Authorisation Safety Study Patient Registry of Patients With Neuroblastoma Being Treated With Dinutuximab Beta","official_title":"A Post-Authorisation Safety Study Patient Registry of Patients With High-risk Neuroblastoma Being Treated With the Monoclonal Antibody Dinutuximab Beta","primary_completion_date":"2032-03-31","study_type":"Observational [Patient Registry]","rec_status":"Recruiting","completion_date":"2032-06-15","last_update":"2021-03-29","description":"This is a non-interventional, multi-national, observational, prospective patient registry to further evaluate the effectiveness and safety of dinutuximab beta - a monoclonal immunoglobulin G 1 (IgG1) antibody, to obtain information on survival, pain severity and incidence of neuro-toxicity, visual impairment, capillary leak syndrome, cardiovascular events, hypersensitivity reactions and long-term safety.","other_id":"EUSA DB 0001","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":1,"maximum_age":18,"population":"Patients diagnosed with high-risk neuroblastoma who are starting treatment with dinutuximab\r\n        beta in the standard clinical practice setting or participating in a clinical trial where\r\n        dinutuximab beta is provided according to the indication as per the country/regional\r\n        marketing authorisation, provide consent/assent and are willing to be followed up for up to\r\n        10 years. Centers who treat neuroblastoma patients with dinutuximab beta will be invited to\r\n        participate in the registry. This includes networks such as the Society of Paediatric\r\n        Oncology for the Treatment of Neuroblastoma (SIOPEN) in Europe.","criteria":"\n        Inclusion Criteria:\r\n\r\n        Patients meeting the following criteria will be considered for inclusion into the registry:\r\n\r\n          -  Patients diagnosed with high-risk neuroblastoma and starting treatment with\r\n             commercially available dinutuximab beta OR\r\n\r\n          -  Patients diagnosed with high-risk neuroblastoma and starting treatment with\r\n             dinutuximab beta in a clinical trial where dinutuximab beta is provided according to\r\n             the country/regional marketing authorisation AND\r\n\r\n          -  Appropriate consent/assent has been obtained for participation in the registry with a\r\n             willingness to be followed up for up to 10 years.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Patient will not be eligible for inclusion if the following criterion applies:\r\n\r\n          -  Patients commencing dinutuximab beta within a clinical trial where the product is\r\n             being provided outside of the country/regional marketing authorisation OR\r\n\r\n          -  Appropriate consent/assent has not been obtained for participation in the registry or\r\n             patient/legal representative is not willing for the patient be followed up for up to\r\n             10 years.\r\n      ","sponsor":"EusaPharma (UK) Limited","sponsor_type":"Industry","conditions":"Neuroblastoma","interventions":[{"intervention_type":"Other","name":"Other: Data-collection","description":"Data will be collected on dose, total cumulative amount of dinutuximab beta per course, dose interruptions, dose discontinuations, prophylactic treatment, use of all concomitant analgesia, assessments of pain, and occurrence of neurotoxicity, visual impairment, capillary leak syndrome, cardiovascular events and hypersensitivity reactions and other AEs."}],"outcomes":[{"outcome_type":"primary","measure":"Assessment of the severity of pain experienced by participants during treatment with dinutuximab beta","time_frame":"First dose of dinutuximab beta to the end of the last 35 day course of the 5th cycle of treatment (each cycle is 35 days)","description":"Assessment of pain severity experienced by participants during the period of first dose of dinutuximab beta to the end of last 35 day course of 5th cycle of treatment"},{"outcome_type":"primary","measure":"Number of participants using analgesics during treatment with dinutuximab beta","time_frame":"First dose of dinutuximab beta to the end of the last 35 day course of the 5th cycle of treatment (each cycle is 35 days)","description":"Use of analgesics during the period of first dose of dinutuximab beta to end of last 35 day course of 5th cycle of treatment"},{"outcome_type":"primary","measure":"Incidence of neurotoxicity, visual impairment, capillary leak syndrome, cardiovascular events and hypersensitivity reactions","time_frame":"First dose of dinutuximab beta to the end of the last 35 day course of the 5th cycle of treatment (each cycle is 35 days)","description":"Incidence of neurotoxicity, visual impairment, capillary leak syndrome, cardiovascular events and hypersensitivity reactions up to the end of the last 35 day course of 5th cycle of treatment"},{"outcome_type":"primary","measure":"Number of participants experiencing serious adverse events (SAEs) and adverse drug reactions (ADRs) during treatment with dinutuximab beta","time_frame":"First dose of dinutuximab beta to the end of the last 35 day course of the 5th cycle of treatment (each cycle is 35 days)","description":"Number of participants experiencing serious adverse events (SAEs) and adverse drug reactions (ADRs) following the end of the last 35 day course of 5th cycle of treatment"},{"outcome_type":"secondary","measure":"Overall Survival (OS)","time_frame":"First dose of dinutuximab beta to the end of the last 35 day course of the 5th cycle of treatment (each cycle is 35 days)","description":"Overall Survival (OS) following the end of the last 35 day course of 5th cycle of treatment"},{"outcome_type":"secondary","measure":"Progression free survival (PFS)","time_frame":"First dose of dinutuximab beta to the end of the last 35 day course of the 5th cycle of treatment (each cycle is 35 days)","description":"Progression free survival (PFS) following the end of the last 35 day course of 5th cycle of treatment"},{"outcome_type":"secondary","measure":"Event Free Survival (EFS)","time_frame":"First dose of dinutuximab beta to the end of the last 35 day course of the 5th cycle of treatment (each cycle is 35 days)","description":"Event Free Survival (EFS) following the end of the last 35 day course of 5th cycle of treatment"}]}
{"nct_id":"NCT04074902","start_date":"2019-09-30","enrollment":100,"brief_title":"Role of Chest Sonography in Evaluation of Pleurodesis in Patients With Malignant Pleural Effusion","official_title":"Role of Chest Sonography in Evaluation of Successful Pleurodesis in Patients With Malignant Pleural Effusion","primary_completion_date":"2019-09-30","study_type":"Observational","rec_status":"Unknown status","completion_date":"2020-09-30","last_update":"2019-08-30","description":"Thoracic ultrasonography easily detects the movement of the visceral pleura on the parietal pleura This sign is absent when pleurodesis is successful.","other_id":"Ultrasaund after pleurodesis","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":40,"maximum_age":90,"population":"100 patients will be chosen at random for one year from the start of the study and will be\r\n        recruited from chest out patient clinc and department Assiut University hospital which are\r\n        eligible for this study","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Any patient with malignant pleural effusion who will undergo palliative treatment with\r\n             insertion of intercostal tube.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients <18 years old, unable to provide informed consent.\r\n\r\n          2. Had an allergy or other contraindication to intrapleural pleurodesis.\r\n\r\n          3. Had evidence of unexpandable lung believed by the responsible clinician to represent\r\n             insufficient.\r\n\r\n          4. pleural apposition that would preclude pleurodesis, and/or had an expected survival\r\n             of<1 month.\r\n      ","sponsor":"Assiut University","sponsor_type":"Other","conditions":"Pleurodesis","interventions":[{"intervention_type":"Device","name":"Device: Ultrasonography","description":"Mindray dp1100 plus."}],"outcomes":[{"outcome_type":"primary","measure":"Evaluate and compare the outcome of pleurodisis by different modalities.","time_frame":"baseline","description":"To compare chest sonographic findings versus Multislice CT findings in detecting endobronchial obstruction in patients with malignant pleural effusion"}]}
{"nct_id":"NCT04025814","start_date":"2019-09-30","phase":"N/A","enrollment":20,"brief_title":"dHealth Solution for Improving Parent Adherence to Behavioral Treatment for ADHD","official_title":"A Digital Health Solution for Improving Parent Adherence to Behavioral Treatment for ADHD","primary_completion_date":"2023-06-30","study_type":"Interventional","rec_status":"Enrolling by invitation","completion_date":"2023-06-30","last_update":"2021-08-27","description":"This study aims to develop, refine and preliminarily test a novel and scalable digital health solution designed to address parent adherence barriers in daily life contexts and increase parent's sustained use of evidence-based parenting strategies.","other_id":"19-28558","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Participation in ongoing CLS-R open trials (total of 8 parents and 4 school mental health\r\n        providers) who met eligibility criteria for their children:\r\n\r\n          -  Child aged 7-11 (grades 2-5)\r\n\r\n          -  Identification by school mental health professionals as experiencing challenges with\r\n             inattention and/or hyperactivity/impulsivity\r\n\r\n          -  Attending a participating SFUSD elementary school full time in a mainstream classroom\r\n\r\n          -  Living with a caretaker who is available to participate in treatment\r\n\r\n          -  Absence of significant visual/hearing impairment, severe language delay, psychosis,\r\n             pervasive developmental disorder, or global intellectual impairment per school records\r\n\r\n          -  Significant ADHD symptoms as evidenced by having (i) six or more symptoms of\r\n             inattention and/or hyperactivity/impulsivity rated as occurring \"often\" or \"very\r\n             often\" by parents or teachers, with each informant endorsing at least two symptoms on\r\n             the Child and Adolescent Symptom Inventory; (ii) at least one area of functioning\r\n             rated as - 3 on the Impairment Rating Scale by both parent and teacher\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Parents and SMHPs who are not participating in ongoing CLS-R trials (Phase 1 only)\r\n\r\n          -  Parents who are not participants in ongoing CLS-R/CLS trial and who do not complete\r\n             CLS-R/CLS by March 2020 (Phase 1 and Phase 2)\r\n      ","sponsor":"University of California, San Francisco","sponsor_type":"Other","conditions":"Attention Deficit Hyperactivity Disorder","interventions":[{"intervention_type":"Device","name":"Device: CaregiverAssist","description":"CaregiverAssist is a proposed dHealth tool to promote parent adherence and sustained strategy use of evidence-based parenting strategies."}],"outcomes":[{"outcome_type":"primary","measure":"System Usability Scale","time_frame":"Change from baseline on technology usability at 6 months","description":"10-item sale for assessing technology product usability"},{"outcome_type":"primary","measure":"Feasibility Rating Scale","time_frame":"Change from baseline on technology use at 6 months","description":"1-5 Likert scale rating of amount of time and level of effort needed to use the tool regularly"},{"outcome_type":"primary","measure":"Parent Acceptability and Satisfaction Questionnaire","time_frame":"Change from baseline on technology use at 6 months","description":"1-5 Likert scale rating level of engagement, usefulness, and acceptability"},{"outcome_type":"primary","measure":"Parent adherence/implementation","time_frame":"Change from baseline on application use at 2 months","description":"5-point Likert scale rating daily use of skills and behavior plans (tracked on application)"},{"outcome_type":"secondary","measure":"Parent Confidence and Motivation to Use Evidence Based Parenting Skills","time_frame":"Change from baseline on confidence and motivation at 2 months","description":"5-point Likert scale of parent rated confidence and motivation"},{"outcome_type":"secondary","measure":"Parent Knowledge of Evidence Based Parenting Skills","time_frame":"Change from baseline on knowledge of EBT at 2 months","description":"Assessed via content question, vignettes, and behavior plans to rate parent knowledge of EBT skills"},{"outcome_type":"secondary","measure":"Alabama Parenting Questionnaire","time_frame":"Change from baseline on parenting skills at 2 months","description":"Assessment of parenting skills"},{"outcome_type":"secondary","measure":"Parenting Stress Index","time_frame":"Change from baseline on parent stress at 2 months","description":"Assessment of parent stress"},{"outcome_type":"secondary","measure":"Barkley Deficit in Executive Functions Scale","time_frame":"Change from baseline on parent executive functioning at 2 months","description":"We will use the Barkley Deficits in Executive Functioning Scale for Adults (BDEFS; Barkley, 2011) which is an empirically based tool for evaluating dimensions of adult executive functioning in daily life. We will use the Overall Executive Functioning Total Score which is a sum of all 89 items (each rated on a likert scale from 1 \"never or rarely\" to 4 \"very often\" such that higher scores represent greater degrees of executive functioning impairments) and possible values on the Total Score range from 89 to 356."},{"outcome_type":"secondary","measure":"Child and Adolescent Symptom Inventory (CASI-V)","time_frame":"Change from baseline on ADHD and oppositional behaviors at 2 months","description":"Assessment of ADHD and oppositional behaviors"},{"outcome_type":"secondary","measure":"Strengths and Difficulties Questionnaire","time_frame":"Change from baseline on child impairments at 2 months","description":"Assessment of child impairments"}]}
{"nct_id":"NCT04101266","start_date":"2019-09-30","phase":"N/A","enrollment":76,"brief_title":"Pain Management in Arthtroscopic Shoulder Surgery","official_title":"Comparison of the Effects Combined Suprascapular and Infraclavicular Nerve Blocks to Interscalene Nerve Block Applied Arthtroscopic Shoulder Surgery","primary_completion_date":"2020-03-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-04-01","last_update":"2021-06-10","description":"It is compared that combined suprascapular and infraclavicular nerve blocks to interscalene nerve block for clinical outcomes after shoulder surgery","other_id":"59/13","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients scheduled for elective shoulder surgery under general anesthesia with\r\n             suprascapular + infraclavicular nerve block or interscalene nerve block for any reason\r\n             ASA 1-3 patients\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Diabetes\r\n\r\n          -  coagulopathy\r\n\r\n          -  local anesthetic allergy\r\n\r\n          -  chronic opioid users\r\n\r\n          -  neurological deficit of the surgical limb\r\n\r\n          -  obstructive or restrictive pulmoner disease\r\n\r\n          -  inability to understand pain scores\r\n      ","sponsor":"Diskapi Yildirim Beyazit Education and Research Hospital","sponsor_type":"Other","conditions":"Arthroscopic Shoulder Surgery","interventions":[{"intervention_type":"Other","name":"Other: Interscalene block","description":"30 minutes before anaesthesia induction interscalene nerve block will be applied with ultrasound guidance with %0,25 bupivacain 20 cc .The sham block consisted of after patients were placed in the lateral decubitus position skin preparation, ultrasound scanning of the suprascapular region, and a dry-needling, all performed to preserve patient blinding in the ISB group patients."},{"intervention_type":"Other","name":"Other: suprascapular and infraclavicular nerve block","description":"30 minutes before anaesthesia induction suprascapular with %0,25 bupivacain 10 cc .and infraclavicular nerve block with %0,25 bupivacain 10 cc will be applied with ultrasound guidance"}],"outcomes":[{"outcome_type":"primary","measure":"postoperative pain: numeric rating scale (NRS)","time_frame":"postoperative 30. minute, 4. hour, 8.hour,12. hour, 24. hour, 48. hour","description":"postoperative pain will be evaluated by numeric rating scale (NRS) ."},{"outcome_type":"secondary","measure":"phrenic nerve paralysis evaluated with ultrasound","time_frame":"thirty minutes after the nerve block","description":"Thirty minutes after the block, M-mode ultrasound examination of the ipsilateral hemidiaphragm was performed to measure diaphragmatic excursion."}]}
{"nct_id":"NCT04151940","start_date":"2019-09-26","enrollment":40,"brief_title":"PET/CT Changes During Chemoimmunotherapy and Radiation Therapy in Patients With Stage IV Non-small Cell Lung Cancer","official_title":"An Observational Study of PET/CT Changes During Chemoimmunotherapy and Radiation Therapy for Patients With Metastatic NSCLC (PET Bright)","primary_completion_date":"2022-06-01","study_type":"Observational","rec_status":"Recruiting","completion_date":"2022-06-01","last_update":"2021-07-14","description":"This study investigates the changes in positron emission tomography (PET)/computed tomography (CT) imaging scans during chemoimmunotherapy and radiation therapy treatment in patients with stage IV non-small cell lung cancer. Analyzing changes in PET/CT imaging scans may help doctors assess and predict patterns of cancer response to chemoimmunotherapy and radiation therapy.","other_id":"RG1005458","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients with metastatic non-small cell lung cancer (NSCLC) scheduled to receive\r\n        chemo-immunotherapy per standard clinical care","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically-confirmed or cytologically-confirmed metastatic NSCLC in patients who\r\n             have not received chemotherapy or immunotherapy for their advanced disease (stage IV\r\n             or recurrent, using the American Joint Committee on Cancer [AJCC]/Union for\r\n             International Cancer Control [UICC] 8th edition for staging)\r\n\r\n          -  Evidence of stage IV disease on imaging by CT, PET/CT, or magnetic resonance imaging\r\n             (MRI)\r\n\r\n          -  Plan to treat with a platinum doublet with a PD1 or PDL1 inhibitor\r\n\r\n          -  Adjuvant chemotherapy or concurrent chemoradiation for early stage disease does not\r\n             count as prior therapy unless subject progressed within 6 months of completion of\r\n             regimen.\r\n\r\n          -  Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version\r\n             (v)1.1, at treating physician's discretion\r\n\r\n          -  Patients with known activating mutations in EGFR, BRAF or known translocation in ALK\r\n             or ROS-1 are eligible provided they have progressed on or were intolerant to Food and\r\n             Drug Administration (FDA) approved targeted therapy\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2\r\n\r\n          -  Creatinine =< 2 mg/dL or creatinine clearance > 50 mL/min\r\n\r\n          -  Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase\r\n             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])\r\n             =< 5x institutional upper limit of normal\r\n\r\n          -  Total bilirubin =< 1.5 mg/dL\r\n\r\n          -  Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (>= 1500 per mm^3)\r\n\r\n          -  Platelet count >= 100 x 10^9/L (>=100,000 per mm^3)\r\n\r\n          -  Capability to understand and comply with the protocol requirements and signed informed\r\n             consent documents\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any known additional malignancy (with exception of non-melanoma skin cancer, in-situ\r\n             breast cancer, low risk prostate cancer, or a malignancy diagnosed >= 3 years prior to\r\n             the current NSCLC diagnosis and with no evidence of requiring active treatment)\r\n\r\n          -  Had prior treatment with an anti-PD-1, or PD-L1 or PD-L2 agent or an antibody\r\n             targeting other immuno-regulatory receptors or mechanisms\r\n\r\n          -  Has any serious or uncontrolled active infection that could create false positives on\r\n             a PET/CT scan, in the opinion of the treating investigator\r\n\r\n          -  Has a history or current evidence of any condition, therapy, or laboratory abnormality\r\n             that might confound the results of the trial, interfere with the subject's\r\n             participation for the full duration of the trial, or is not in the best interest of\r\n             the subject to participate, in the opinion of the treating investigator\r\n\r\n          -  Has an active autoimmune disease currently requiring systemic treatment (e.g. disease\r\n             modifying agents, corticosteroids or immunosuppressive drugs)\r\n\r\n             **Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid\r\n             replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a\r\n             form of systemic treatment\r\n\r\n          -  Has known, active, and symptomatic central nervous system (CNS) metastases and/or\r\n             carcinomatous meningitis\r\n\r\n               -  Patients with stable or previously treated brain metastases are eligible as long\r\n                  as they are not receiving more than 10 mg of prednisone, or equivalent, per day\r\n      ","sponsor":"University of Washington","sponsor_type":"Other","conditions":"Metastatic Lung Non-Small Cell Carcinoma|Recurrent Lung Non-Small Cell Carcinoma|Stage IV Lung Cancer AJCC v8|Stage IVA Lung Cancer AJCC v8|Stage IVB Lung Cancer AJCC v8","interventions":[{"intervention_type":"Procedure","name":"Procedure: Positron Emission Tomography","description":"Undergo PET/CT scan"},{"intervention_type":"Procedure","name":"Procedure: Computed Tomography","description":"Undergo PET/CT scan"},{"intervention_type":"Drug","name":"Drug: Chemotherapy","description":"Receive standard of care chemotherapy"},{"intervention_type":"Biological","name":"Biological: Immunotherapy","description":"Receive standard of care immunotherapy"},{"intervention_type":"Radiation","name":"Radiation: Radiation Therapy","description":"Undergo standard of care radiation therapy"}],"outcomes":[{"outcome_type":"primary","measure":"Progression-free survival (PFS)","time_frame":"At 1 year","description":"Will be compared between high-risk and low-risk subgroups of patients based on PET imaging response assessment using a two-sample proportionality test. Interim and final statistical analyses of PFS will consist of Kaplan-Meier estimation and Cox proportional hazard regression."}]}
{"nct_id":"NCT04919291","start_date":"2019-09-26","phase":"N/A","enrollment":21,"brief_title":"Direct Comparison of TG and WFO LASIK","official_title":"Contralateral Comparison of Togoguided LASIK and Wavefront-optimized LASIK","primary_completion_date":"2020-03-14","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-06-30","last_update":"2021-06-09","description":"To compare the efficacy to different profiles, direct head-to-head studies had been conducted. In one previous review study revealed that TG LASIK provided patient with better uncorrected visual acuity (UCVA) than WFO LASIK and WFG LASIK. In recent previous contralateral eye studies also showed that TG LASIK induced less postoperative higher-order aberration than WFO LASIK. However, these studies included only low-to-moderate myopia patients, for patients with high myopia (spherical equivalent > 6D), the effect of TG LASIK comparing with WFO LASIK had not been reported before. The aim of our study is to analyze and compare the visual performance of TG LASIK and WFO LASIK in high myopia and low-to-moderate myopia patients, , particularly UCVA, corrected distance visual acuity (CDVA), contrast sensitivity (CS), and wavefront aberration.","other_id":"002","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  age between 20 and 50 years old\r\n\r\n          -  CDVA of both eyes could reach 0.1 logarithm of the minimum angle of resolution\r\n             (logMAR)\r\n\r\n          -  stable refractive errors of myopia and astigmatism\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  cataract\r\n\r\n          -  corneal opacities or irregularities\r\n\r\n          -  dry eye (Schirmer's test I  5mm)\r\n\r\n          -  amblyopia\r\n\r\n          -  coexisting ocular pathologies\r\n\r\n          -  glaucoma\r\n\r\n          -  non-dilating pupil\r\n\r\n          -  history of intraocular surgery, laser therapy, or retinopathy\r\n\r\n          -  optic nerve or macular diseases\r\n\r\n          -  estimated postoperative cornea residual stromal thickness less than 250 m\r\n\r\n          -  pregnancy or under lactation\r\n\r\n          -  uncontrolled diabetic mellitus or systemic immune disease\r\n\r\n          -  refusal or unable to maintain follow-up\r\n      ","sponsor":"Taipei Nobel Eye Clinic","sponsor_type":"Other","conditions":"Keratomileusis, Laser In Situ|Contrast Sensitivity","interventions":[{"intervention_type":"Device","name":"Device: Topoguided LASIK","description":"Topoguided ablation profile on dominant eye"},{"intervention_type":"Device","name":"Device: Wavefront optimized LASIK","description":"Wavefront optimized ablation profile on non-dominant eye"}],"outcomes":[{"outcome_type":"primary","measure":"Visual acuity","time_frame":"3 months after surgery","description":"uncorrected visual acuity and corrected distance visual acuity"},{"outcome_type":"primary","measure":"Corneal wavefront analysis","time_frame":"3-months postoperative visit","description":"horizontal coma aberration (Z 3,1), spherical aberration (Z 4,0), and trefoil aberration"},{"outcome_type":"primary","measure":"Contrast sensitivity","time_frame":"3-months postoperative visit","description":"4 spatial frequencies: 3, 6, 12, and 18 cycles per degree (cpd)."},{"outcome_type":"primary","measure":"Quality of vision questionnaire","time_frame":"3-months postoperative visit","description":"A 11-item questionnaire, item scores range from 0 to 10 and higher item scores in questionnaire indicated more difficulty in achieving specific visual tasks"}]}
{"nct_id":"NCT04043520","start_date":"2019-09-24","phase":"Phase 4","enrollment":95,"brief_title":"Bioenergetic Effects of Aging and Menopause (BEAM)","official_title":"Bioenergetic and Metabolic Consequences of the Loss of Ovarian Function in Women - 2018","primary_completion_date":"2024-08-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2024-08-31","last_update":"2021-07-14","description":"The menopause transition is associated with increased risk for weight gain and a shift toward storing fat in the belly region, which may increase risk for cardiovascular disease and diabetes. The stress hormone cortisol is known to promote the accumulation of belly fat, and there is evidence that low estrogen is associated with higher cortisol levels. The first aim of the study is to determine whether low estrogen levels in premenopausal and early postmenopausal women increase cortisol levels in the blood and in fat tissue. When estrogen level decreases at the time of menopause, there is an increase in follicle-stimulating hormone, or FSH. Recent evidence in mice suggests that blocking FSH prevents the increase in belly fat. The second aim of the study is to determine whether decreasing the high FSH level in postmenopausal women causes a decrease in belly fat and changes other factors that are typically thought to be related to estrogen rather than FSH. Because estrogen and FSH levels fluctuate in premenopausal and early postmenopausal women, the investigators will use an approach that controls estrogen and FSH levels to address the aims. The investigators will use a drug that is typically used to treat endometriosis or uterine fibroids to reduce estrogen and FSH levels and an estrogen patch to increase estrogen in some women. The study will generate new knowledge on how menopause affects fat gain and disease risk.","other_id":"18-2483","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"Triple","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Volunteers will be healthy premenopausal and postmenopausal women who are willing and able\r\n        to undergo the proposed hormone manipulation and study procedures. Premenopausal women will\r\n        be aged 18 y or older with normal menstrual cycle function and FSH <10 IU/L. Postmenopausal\r\n        women will be those who are at least 6 months but not more than 7 years past the last\r\n        menstrual period (i.e., late perimenopausal or early postmenopausal) with FSH >30 IU/L. We\r\n        will make a major effort to ensure that the women enrolled in this study come from all\r\n        races and ethnicities and a wide range of socioeconomic and educational levels. Women will\r\n        be excluded for the reasons listed below.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  for premenopausal women, irregular menstrual cycles defined as more than 1 missed\r\n             cycle in the previous year\r\n\r\n          -  abnormal vaginal bleeding\r\n\r\n          -  on hormonal contraceptive or menopausal therapy or intention to start during the\r\n             period of study\r\n\r\n          -  positive pregnancy test or intention to become pregnant during the period of study\r\n\r\n          -  lactation\r\n\r\n          -  known hypersensitivity to degarelix acetate, estradiol, or medroxyprogesterone acetate\r\n\r\n          -  Center for Epidemiological Studies Depression Scale (CES-D) score <,16 (unless\r\n             clinician follow-up and clinical judgement determine they are eligible (will be noted\r\n             in study chart)\r\n\r\n          -  current tobacco and/or vape use more than 2 times/week\r\n\r\n          -  current marijuana or tetrahydrocannabinol (THC) use in any form more than 3 times/week\r\n\r\n          -  regular self-reported alcohol consumption >14 drinks/week\r\n\r\n          -  BMI >39 kg/m2\r\n\r\n          -  use of glucocorticoids or drugs that affect glucocorticoid metabolism (e.g.,\r\n             ketoconazole)\r\n\r\n          -  severe osteopenia or osteoporosis, defined as femoral neck or lumbar spine t-score\r\n             <-2.0\r\n\r\n          -  thyroid dysfunction, defined as an ultrasensitive TSH <0.5 or >5.0 mU/L; volunteers\r\n             with abnormal thyroid stimulating hormone (TSH) values will be re-considered for\r\n             participation in the study after follow-up evaluation by the PCP with initiation or\r\n             adjustment of thyroid hormone replacement\r\n\r\n          -  liver dysfunction, defined as liver function tests (AST, ALT) >1.5 times the upper\r\n             limit of normal\r\n\r\n          -  uncontrolled hypertension defined as resting systolic BP >150 mmHg or diastolic BP>90\r\n             mmHg; participants who do not meet these criteria at first screening will be\r\n             re-evaluated, including after follow-up evaluation by the primary care provider (PCP)\r\n             with initiation or adjustment of anti-hypertensive medications\r\n\r\n          -  self-reported history of breast cancer or other estrogen-dependent neoplasms\r\n\r\n          -  self-reported history of venous thromboembolism, pulmonary embolism, or other\r\n             thromboembolic disorder\r\n\r\n          -  self-reported history of cardiovascular disease\r\n      ","sponsor":"University of Colorado, Denver","sponsor_type":"Other","conditions":"Menopause|Obesity, Abdominal|Aging|Weight Gain","interventions":[{"intervention_type":"Drug","name":"Drug: GnRH antagonist","description":"GnRH antagonist will be given once for premenopausal women (12-week intervention) and twice for postmenopausal women (24-week intervention)"},{"intervention_type":"Drug","name":"Drug: Estrogen Product","description":"Estrogen patches will be worn by those randomized to the Estradiol arms in both premenopausal and postmenopausal groups. Patches will be applied weekly and will be worn for the for entirety of the intervention (12 or 24 weeks)."},{"intervention_type":"Drug","name":"Drug: Placebo estradiol","description":"Placebo patches will be worn by those randomized to the placebo arms in both premenopausal and postmenopausal groups. Patches will be applied weekly and will be worn for the for entirety of the intervention (12 or 24 weeks)."},{"intervention_type":"Drug","name":"Drug: Placebo GnRH antagonist","description":"Postmenopausal women randomized to the placebo injection arm will receive two placebo drug injections of normal saline (24-week intervention)"}],"outcomes":[{"outcome_type":"primary","measure":"Change in the Microdialysis Cortisone Challenge (MCC) Index","time_frame":"Baseline, week 12","description":"The MCC Index is an in vivo measurement of local cortisol production in abdominal adipose tissue. A higher MCC Index is an indicator of more local cortisol production."},{"outcome_type":"primary","measure":"Change in the Oral Cortisone Challenge (OCC) Area Under the Curve (AUC)","time_frame":"Baseline, week 12","description":"The OCC AUC is a systemic measurement of peripheral glucocorticoid metabolism. A higher OCC AUC is an indicator of more production of cortisol."},{"outcome_type":"secondary","measure":"Change in lumbar spine Bone Mineral Density (BMD)","time_frame":"Baseline, week 24","description":"Lumbar spine BMD is measured by dual-energy x-ray absorptiometry. A higher BMD is a general indicator of less risk for osteoporosis."},{"outcome_type":"secondary","measure":"Change in resting energy expenditure (REE)","time_frame":"Baseline, week 12, week 24","description":"REE is an index of metabolic rate at rest, measured by indirect calorimetry. A higher REE is an indicator of greater energy expenditure at rest."},{"outcome_type":"secondary","measure":"Change in visceral fat area (VFA)","time_frame":"Baseline, week 24","description":"VFA of the abdominal visceral region is measured by computed tomography. VFA is an indicator of the amount of fat stored in this region."},{"outcome_type":"secondary","measure":"Change in flow-mediated dilation (FMD)","time_frame":"Baseline, week 12, week 24","description":"FMD of the brachial artery as an index of vascular function. A higher number is a general indicator of better vascular function."},{"outcome_type":"secondary","measure":"Change in proximal femur Bone Mineral Density (BMD)","time_frame":"Baseline, week 24","description":"Proximal femur BMD is measured by dual-energy x-ray absorptiometry. A higher BMD is a general indicator of less risk for osteoporosis."}]}
{"nct_id":"NCT04121221","start_date":"2019-09-19","phase":"Phase 3","enrollment":1016,"brief_title":"A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS","official_title":"A Phase III Study in Subjects With Relapsing Forms of Multiple Sclerosis (RMS) to Asses Efficacy, Safety and Tolerability of GA Depot, a Long Acting IM Injection of Glatiramer Acetate, Once Monthly Compared to Placebo","primary_completion_date":"2022-06-30","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2023-06-30","last_update":"2021-08-12","description":"A multinational, multicenter, randomized, Phase III, double blind, parallel group, placebo controlled study in subjects with Relapsing Forms of Multiple Sclerosis (RMS) to assess the efficacy, safety and tolerability of GA Depot, a long acting IM injection of glatiramer acetate, administered once every four weeks","other_id":"Mapi GA Depot Phase III - 001","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","intervention_model_description":"During the placebo controlled period subjects will receive either 40mg of GA Depot or matching placebo, IM, once every 4 weeks, for a total of 13 times.\r\nSubjects who complete the PC period of the study will be offered to continue into the open label period for an additional 52 weeks, in which all subjects will receive 40mg of GA Depot IM once every 4 weeks.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Inclusion criteria:\r\n\r\n          1. Adult subjects between 18-55 years of age, inclusive.\r\n\r\n          2. Subjects able to provide signed written informed consent.\r\n\r\n          3. Subjects must be willing and able to comply with the protocol requirements for the\r\n             duration of the study.\r\n\r\n          4. MS diagnosis fulfilling the 2017 McDonald Criteria.\r\n\r\n          5. Subjects should be ambulatory with an EDSS score of 0-5.5 at screening and baseline\r\n             visits. EDSS score will be determined by a separate, blinded trained EDSS rater.\r\n\r\n          6. Subjects should be relapse free and neurologically stable from one month before\r\n             screening visit and from screening visit to baseline visit.\r\n\r\n          7. No systemic corticosteroid treatment or ACTH within one month prior to screening\r\n             visit.\r\n\r\n          8. Subjects must have experienced at least one of the following:\r\n\r\n             i. At least one documented relapse in the 12 months prior to screening. ii. At least\r\n             two documented relapses in the 24 months prior to screening. iii. One documented\r\n             relapse between 12 and 24 months prior to screening, with at least one documented\r\n             T1-Gd enhancing lesion in MRI performed within 0-12 months before screening.\r\n\r\n          9. Women capable of child bearing must have a negative urine pregnancy test at screening\r\n             and baseline visit and use an adequate contraceptive method throughout the study.\r\n\r\n        Exclusion criteria:\r\n\r\n          1. Use of experimental / investigational drug, and / or participation in drug clinical\r\n             studies within the 6 months prior to screening.\r\n\r\n          2. Any off-label drug use for MS treatment such as high dose simvastatin and biotin\r\n             within 6 months prior to screening.\r\n\r\n          3. Previous use of immunosuppressant including Mitoxantrone, Alemtuzumab, Cladribine or\r\n             any other cytotoxic agent within 5 years.\r\n\r\n          4. Previous use of Natalizumab or any anti-B cell agent within 9 months prior to\r\n             screening.\r\n\r\n          5. Previous use of Fingolimod or any other sphingosine-1-phosphate receptor modulator,\r\n             Dimethyl Fumarate, Diroximel Fumarate (DRF), or Monomethyl fumarate within 2 months\r\n             prior to screening. Subjects will be excluded if they do not have a lymphocyte count\r\n             of above 1,000/mm3 at screening.\r\n\r\n          6. Previous use of Teriflunomide within 12 months if no accelerated elimination procedure\r\n             was used.\r\n\r\n          7. Previous treatment with immunomodulators (including IFN 1a and 1b, and IV\r\n             Immunoglobulin (IVIg) within 2 months prior to screening.\r\n\r\n          8. Previous use of GA or any other glatiramoid.\r\n\r\n          9. Chronic (more than 30 consecutive days) systemic (IV, PO or IM) corticosteroid\r\n             treatment within 6 months prior to screening visit.\r\n\r\n         10. Previous total body irradiation or total lymphoid irradiation.\r\n\r\n         11. Previous stem-cell treatment, autologous bone marrow transplantation or allogeneic\r\n             bone marrow transplantation.\r\n\r\n         12. Subjects with a clinically significant or unstable medical, psychiatric, or surgical\r\n             conditions that would preclude safe and complete study participation, as determined by\r\n             medical history, physical exams, ECG and/or abnormal laboratory tests; and or subjects\r\n             with an increased risk of serious Covid-19 related morbidity. Such conditions may\r\n             include hepatic, renal or metabolic diseases, systemic disease, acute infection,\r\n             current malignancy, or recent history (5 years) of malignancy, major psychiatric\r\n             disorder, history of drug and/or alcohol abuse and allergies that could be detrimental\r\n             according to the investigator's judgment.\r\n\r\n         13. Subjects who have >10 T1-Gd enhancing lesions at screening.\r\n\r\n         14. A known history of sensitivity to Gadolinium.\r\n\r\n         15. Inability to successfully undergo MRI scanning.\r\n\r\n         16. Pregnant or breast-feeding women.\r\n\r\n         17. Abnormal renal function.\r\n\r\n         18. Abnormal liver function.\r\n\r\n         19. History of any anaphylactic reaction and/or serious allergic reaction following a\r\n             vaccination, a proven hypersensitivity to any component of the study article (e.g.,\r\n             GA, Polyglactin, PVA).\r\n\r\n         20. Positive testing or a history of positive testing for syphilis, HIV, hepatitis, or\r\n             tuberculosis.\r\n\r\n         21. Known or suspected history of drug or alcohol abuse.\r\n\r\n         22. Subjects diagnosed with any systemic autoimmune disease (other than MS) that may\r\n             impact the CNS with MS like lesions such as Sarcoidosis, Sjgren's syndrome, Systemic\r\n             Lupus Erythematosus (SLE), Lyme disease, Antiphospholipid antibodies (APLA) syndrome,\r\n             etc. Subjects with stable local/organ autoimmune disease such as psoriasis, cutaneous\r\n             lupus erythematosus, thyroiditis (Hashimoto's, Grave's) etc. may be considered\r\n             eligible upon the investigator's discretion.\r\n\r\n         23. Any CNS disorder other than MS that may jeopardize the subject's participation in the\r\n             study.\r\n\r\n         24. Subjects with uncontrolled diabetes.\r\n\r\n         25. Subjects with clotting disorders or receiving treatment with anticoagulants.\r\n      ","sponsor":"Mapi Pharma Ltd.","sponsor_type":"Industry","conditions":"Multiple Sclerosis, Relapsing-Remitting","interventions":[{"intervention_type":"Drug","name":"Drug: GA Depot","description":"Long acting intramuscular injection of glatiramer acetate, once every 4 weeks"},{"intervention_type":"Other","name":"Other: Placebo","description":"IM injection once every 4 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Annualized Relapse Rate (ARR)","time_frame":"52 weeks","description":"Annualized Relapse Rate (ARR) will be derived from the total number of confirmed relapses."},{"outcome_type":"secondary","measure":"Changes in brain MRI (number of T1 lesions)","time_frame":"52 weeks","description":"Cumulative number of new enhancing lesions on T1-weighted images as compared to baseline."},{"outcome_type":"secondary","measure":"Changes in brain MRI (number of T2 lesions)","time_frame":"52 weeks","description":"Cumulative number of new or newly enlarging hyperintense T2 lesions as compared to baseline."},{"outcome_type":"secondary","measure":"Hyperintense T2-lesion volume change","time_frame":"52 weeks","description":"Change from baseline to Week 52 in hyperintense T2-lesion volume."},{"outcome_type":"secondary","measure":"Enhancing T1-lesion volume change","time_frame":"52 weeks","description":"Change from baseline to Week 52 in enhancing T1-lesion volume."}]}
{"nct_id":"NCT04008784","start_date":"2019-09-16","enrollment":16,"brief_title":"Improvement of Short Term Outcome of Mild to Moderate Atopic Dermatitis Using a Combination of Crisaborole and a Concomitant Topical Corticosteroid Over a 8 Week Period","official_title":"Improvement of Short Term Outcome of Mild to Moderate Atopic Dermatitis Using a Combination Treatment of Crisaborole Ointment, 2% and a Concomitant Topical Corticosteroid Over a 8 Week Period","primary_completion_date":"2020-07-14","study_type":"Observational","rec_status":"Completed","completion_date":"2020-09-08","last_update":"2021-04-28","description":"This trial is a single-center two arm, open label observational prospective study, that will evaluate the safety and efficacy of crisaborole ointment, 2% alone compared to a combination therapy of crisaborole and a topical corticosteroid (Triamcinolone Acetonide Ointment, 0.1%) over a 8 week period for the treatment of mild to moderate atopic dermatitis.","other_id":"CRCC-2019-001","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":2,"maximum_age":79,"population":"Male and female patients age 2 to 79 years of age with confirmed diagnosis of atopic\r\n        dermatitis","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male and female patients age 2 to 79 years of age with confirmed diagnosis of atopic\r\n             dermatitis\r\n\r\n          -  Clinical diagnosis of atopic dermatitis that has been clinically stable for 1 month\r\n\r\n          -  Total body surface area (BSA) of atopic dermatitis involvement 35%, excluding\r\n             involvement of the scalp.\r\n\r\n          -  Patient or patient's parent(s)/legal representative guardian must be willing and able\r\n             to apply study medications as directed, comply with study instructions, and commit to\r\n             attending all visits.\r\n\r\n          -  Females of childbearing potential must use at least one highly effective method of\r\n             birth control. Males with partners of childbearing potential should inform them of\r\n             their participation in this clinical study and use highly effective methods of birth\r\n             control during the study.\r\n\r\n          -  Patient or patient's parent(s)/legal representative must be capable of giving written\r\n             informed consent or verbal assent, as applicable, which includes compliance with the\r\n             requirements and restrictions listed in the consent/assent form; written informed\r\n             consent must be obtained prior to any study related procedures.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Concurrent or recent use of certain topical or systemic medications or phototherapy\r\n             without a sufficient washout period.\r\n\r\n          -  Active or potentially recurrent dermatologic condition other than atopic dermatitis in\r\n             the target lesion area that may confound evaluation.\r\n\r\n          -  Significant confounding conditions as assessed by study doctor.\r\n\r\n          -  History or evidence of allergies requiring acute or chronic treatment (except seasonal\r\n             allergic rhinitis).\r\n\r\n          -  Participated in any other trial of an investigational drug or device within 30 days or\r\n             participation in a research study concurrent with this study\r\n\r\n          -  Pregnancy or lactation.\r\n\r\n          -  History of sensitivity to the study medications, or components thereof or a history of\r\n             drug or other allergy that, in the opinion of the Investigator or medical monitor,\r\n             contraindicates their participation.\r\n\r\n          -  Patients with active infection in atopic dermatitis areas requiring antibiotics,\r\n             antifungals, or antiviral agents within 7 days of Baseline (Day 0).\r\n\r\n          -  Patients with pruritus due to conditions other than atopic dermatitis that, in the\r\n             opinion of the Investigator, would either interfere with study evaluations or affect\r\n             the safety of the patient.\r\n\r\n          -  History of and/or concurrent condition of serious hypersensitivity (anaphylactic shock\r\n             or anaphylactoid reaction) to PDE4 inhibitors.\r\n\r\n          -  Use of any prohibited medication. Prohibited concomitant medications, therapy, etc.\r\n\r\n        during the defined period are as listed below. If a patient requires any of these\r\n        medications throughout the study period, he/she may be excluded from or discontinued from\r\n        the study, at the discretion of the Investigator and medical monitor.  From 6 Months prior\r\n        to the first application of the study drug: Biological products that might have\r\n        significantly affected the evaluation of atopic dermatitis condition (e.g., tumor necrosis\r\n        factor [TNF] inhibitors, antiimmunoglobulin [Ig]E antibodies, anti-CD20 antibodies,\r\n        anti-interleukin [IL]-4 receptor\r\n\r\n         From 21 days prior to the first application of study drug: Corticosteroid preparations\r\n        (oral, injection, and suppository preparations) and topical corticosteroids that were\r\n        classified as super-high potency (clobetasol propionate).\r\n\r\n        Oral preparations and injections of immunosuppressants (cyclosporine, methotrexate,\r\n        azathioprine, tacrolimus, etc.); Excessive sun exposure, tanning booth, other ultraviolet\r\n        (UV) light source and phototherapy including psoralen and ultraviolet A (PUVA) therapy. \r\n        From 14 days prior to the first application of the study drug: any other topical\r\n        phosphodiesterase 4 (PDE4) inhibitor; Tacrolimus and pimecrolimus cream and/or ointment;\r\n        Topical corticosteroids that were classified as low, medium, or high potency (e.g.,\r\n        fluocinonide, triamcinolone acetonide, desonide, hydrocortisone).\r\n\r\n        Eye drops and nasal preparations are allowed.\r\n\r\n         From 7 days prior to the first application of the study drug: Oral or intravenous\r\n        antibiotics, antifungal or antivirus medications Antihistamines/anti-allergics (oral,\r\n        topical and injections): diphenhydramine, chlorpheniramine maleate, hydroxyzine).\r\n\r\n          -  Visible skin disease or damaged skin at the application site\r\n\r\n          -  Psoriasis and/or active atopic dermatitis/eczema\r\n\r\n          -  Not willing to refrain from using any topical/systemic analgesics such as aspirin\r\n\r\n          -  Pregnant, plan to become pregnant during the study, or are breast-feeding a child\r\n\r\n          -  Using medication which, in the opinion of the investigative personnel, will interfere\r\n             with the study results, including anti-inflammatory medications\r\n\r\n          -  Any known sensitivity to adhesives;\r\n\r\n          -  Received treatment for any type of internal cancer within 5 years prior to study\r\n             entry; or have a history of, or are currently being treated for skin cancer;\r\n\r\n          -  Has unstable AD or any consistent requirement for high-potency topical corticosteroids\r\n             to manage AD signs and symptoms\r\n\r\n          -  Has any clinically significant medical disorder, condition, or disease or clinically\r\n             significant physical examination finding at Screening that may interfere with study\r\n             objectives/safety of participants\r\n      ","sponsor":"Clinical Research Center of the Carolinas","sponsor_type":"Other","conditions":"Atopic Dermatitis","interventions":[{"intervention_type":"Drug","name":"Drug: Crisaborole 2% Topical Application Ointment [EUCRISA]","description":"Ointment"},{"intervention_type":"Drug","name":"Drug: Triamcinolone Acetonide 0.1% Ointment","description":"Topical Corticosteroid"}],"outcomes":[{"outcome_type":"primary","measure":"Investigator Global Assessment","time_frame":"Week 8","description":"2 grade or greater improvement from baseline"},{"outcome_type":"secondary","measure":"Improvement in Patient Itching","time_frame":"Week 8","description":"Visual Analog Scale (1-10) for Itching improvement"}]}
{"nct_id":"NCT04196881","start_date":"2019-09-16","phase":"N/A","enrollment":100,"brief_title":"Effect of Attention Deficit Hyperactivity Disorder Knowledge Improvement Program on Male Primary School Teachers","official_title":"Effect of Attention Deficit Hyperactivity Disorder Knowledge Improvement Program on Male Primary School Teachers in Abha City: A Randomized Controlled Trial","primary_completion_date":"2020-01-01","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2020-02-01","last_update":"2019-12-13","description":"The study aims to assess the impact of implementing ADHD knowledge improvement program on male primary school teachers' knowledge regarding ADHD in Abha City, Saudi Arabia.","other_id":"ADHD","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male teachers in governmental and private primary schools in Abha City, Saudi Arabia.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Those who have a similar training program before.\r\n\r\n          -  Those who are not directly involved in the teaching process.\r\n      ","sponsor":"King Khalid University","sponsor_type":"Other","conditions":"ADHD|Mental Disorder|Attention Deficit Hyperactivity Disorder","interventions":[{"intervention_type":"Other","name":"Other: Knowledge Improvement Program about ADHD","description":"This training program will cover an overview of ADHD, prevalence, causes, symptoms, risk factors, associated impairment, prognosis, and treatment options including behavioral interventions and medication."}],"outcomes":[{"outcome_type":"primary","measure":"Teachers' Knowledge questionnaire","time_frame":"1 month","description":"A self-administered questionnaire. The questionnaire composed of 6 items covering socio-demographic characteristics of teachers (age, nationality, years of experience, education level, specialty and type of school) and 20 items assessing teachers' knowledge of ADHD. Each item was assessed on a 2-point scale (incorrect response and don't know = 0, correct response = 1) with a maximum score of 20. The questionnaire items were as follows: nature of disease (1 item), age of onset (1 item), sex prevalence (1 item), disease course (1 item), symptoms (7 items), risk factors (4 items), aggravating factors (4 items) and management (1 item). Adequate knowledge was considered when the teachers achieved 65% of the total score."}]}
{"nct_id":"NCT03999411","start_date":"2019-09-09","phase":"Phase 4","enrollment":37,"brief_title":"Smartphone Intervention for Smoking Cessation and Adherence to Anti-Retroviral Therapy (ART) Among People Living With Human Immunodeficiency Virus (HIV)","official_title":"A Novel Smartphone-based Intervention to Support Smoking Cessation and Adherence to Antiretroviral Therapy Among People Living With HIV: A Pilot Randomized Clinical Trial","primary_completion_date":"2020-10-14","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-10-14","last_update":"2021-03-05","description":"The purpose of this study is to learn if a mindfulness-based smoking cessation smartphone app can help people quit smoking and stay on antiretroviral therapies.","other_id":"20190181","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -    18 years old\r\n\r\n          -  Diagnosed with HIV\r\n\r\n          -  have been prescribed ART medication in the prior 6 months\r\n\r\n          -  have smoked  5 cigarettes/day in the past year\r\n\r\n          -  be interested in making a quit attempt in the next 30 days\r\n\r\n          -  own a smartphone (apple/android)and plan to keep it active for the following 3 months\r\n\r\n          -  read/speak English\r\n\r\n          -  be able to provide consent\r\n\r\n          -  have no plans to move in the next 3 months\r\n\r\n          -  not pregnant or planning to be pregnant in the following 3 months\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Adults unable to consent\r\n\r\n          -  Individuals who are not yet adults (infants, children, teenagers)\r\n\r\n          -  Pregnant women\r\n\r\n          -  Prisoners\r\n\r\n          -  Those that regularly use tobacco products other than cigarettes\r\n\r\n          -  Those that use drugs (methadone, alcohol, cocaine, marijuana) more than once-a-week.\r\n\r\n          -  Have contraindication to NRT (past month myocardial infarction, history of serious\r\n             arrhythmias/or unstable angina pectoris, dermatological disorder)\r\n\r\n          -  Have cognitive/mental health impairment that inhibits mindfulness treatment\r\n\r\n          -  Use other tobacco products regularly (which can interfere with biological verification\r\n             of smoking cessation)\r\n\r\n          -  Currently being treated for smoking cessation, alcoholism, or illicit drug use\r\n      ","sponsor":"University of Miami","sponsor_type":"Other","conditions":"Smoking|Smoking Cessation|HIV","interventions":[{"intervention_type":"Drug","name":"Drug: Nicoderm C-Q Transdermal Product","description":"6 weeks of GlaxoSmithKline Nicoderm CQ (NRT)"},{"intervention_type":"Behavioral","name":"Behavioral: Adherence to Antiretroviral Therapy Counseling","description":"Brief counseling on adhering to antiretroviral therapy with self-help materials."},{"intervention_type":"Behavioral","name":"Behavioral: Behavioral Smoking Cessation Counseling","description":"One time face-to-face smoking cessation counseling and 2 follow-up phone calls."},{"intervention_type":"Behavioral","name":"Behavioral: \"Crave-to-Quit\" app","description":"Evidence-based mindfulness smoking cessation smartphone app (\"Crave-to-Quit\") adapted from an in-person mindfulness training relapse prevention smoking cessation intervention."},{"intervention_type":"Behavioral","name":"Behavioral: vDOT \"emocha\" app","description":"Video Directly Observed Therapy (vDOT) smartphone app (\"emocha\") that allows participants to take a video of themselves taking medication to ensure adherence."}],"outcomes":[{"outcome_type":"primary","measure":"Number of participants with smoking cessation","time_frame":"3 months","description":"Participants who self-report seven days of non-smoking."},{"outcome_type":"primary","measure":"Number of participants with confirmed adherence to ART","time_frame":"3 months","description":"Measured by visual analogue scale (VAS) ranging from 0 to 100%. The ART medication visual analogue scale is an instrument for patients to rate their dose taken percentages. 100% of doses taken will be regarded as good adherence. Participants who scores 95 and higher will provide blood samples for confirmation. Participant's plasma HIV-1 Ribonucleic Acid Viral Load (RNA VL) must be < 40 copies/ml to confirm ART adherence."},{"outcome_type":"primary","measure":"Usability of intervention","time_frame":"3 months","description":"The usability of the Crave-to Quit and Emocha apps will be assessed via a questionnaire with scores ranging from 0-10 with the higher score indicating increased comfortability with using the app."},{"outcome_type":"primary","measure":"Acceptability of intervention","time_frame":"3 months","description":"The acceptability is be assessed by 3 items \"How satisfied were you with the intervention?\", \"How likely are you to recommend this intervention to a friend?\" and \"How useful was the intervention?\" Each question is scored from 0-10 with the higher score indicating increased acceptability."},{"outcome_type":"primary","measure":"Engagement with the intervention","time_frame":"3 months","description":"Participant engagement is evaluated via self-reported use of the Crave-to-Quit and Emocha apps. Participants will complete a questionnaire indicating how often they used the apps. The scores will range from 0 to 5 with 0 indicating no use at all and 5 indicating daily use."},{"outcome_type":"primary","measure":"Feasibility of delivery","time_frame":"3 months","description":"The feasibility of delivery will be assessed via evaluating the percentage of: recruitment rate, effort required, screenings conducted, eligible participants, participants who agree to enroll, rescheduled visits, cancellation of visits, missed visits, attrition, lost to follow up, response and adherence/compliance."},{"outcome_type":"secondary","measure":"Number of participants with reported relapse","time_frame":"3 months","description":"Number of participants who have smoked at least once per week on two consecutive weeks after smoking cessation was confirmed."},{"outcome_type":"secondary","measure":"Change in number of cigarettes smoked per day","time_frame":"Baseline, 3 months","description":"Self-reported number of cigarettes smoked per day by each participant. (Q. On average, how many cigarettes do you smoke per day?)"}]}
{"nct_id":"NCT04062305","start_date":"2019-09-09","phase":"N/A","enrollment":22,"brief_title":"nTMS in Planning Stereotactic Radiosurgery in Patients With Brain Metastases in the Motor Cortex","official_title":"Feasibility of Navigated Transcranial Magnetic Stimulation (nTMS) of Patients Treated With Stereotactic Radiosurgery for Brain Metastases in the Motor Cortex: A Comprehensive Cross-Sectional Assessment","primary_completion_date":"2021-05-06","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-05-06","last_update":"2020-02-11","description":"This trial studies how well nTMS works in planning for stereotactic radiosurgery in patients with brain metastases in the motor cortex. Stereotactic radiosurgery is a type of radiation therapy that delivers high doses of radiation, which can sometimes lead to damage occurring to the brain and surrounding areas. The motor cortex (the part of the nervous system that controls muscle movement), however, currently has no radiation dose limit. nTMS is a non-invasive tool that uses sensors on a patient's muscle to trace the location in their brain that controls that muscle and is currently used by doctors to decide where to operate so as not to damage the motor nerves. nTMS may effectively help plan radiation treatment using SRS and help doctors decide on how much radiation can be used on motor nerves.","other_id":"2019-0302","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adult patients with brain metastases located in or near the motor cortex who have\r\n             previously received SRS to that lesion within the prior 3-18 months\r\n\r\n          -  Patients must be able to participate in nTMS of bilateral motor cortices\r\n\r\n          -  Patients must be able to participate in an electromyography (EMG)\r\n\r\n          -  Patient's must have utilized magnetic resonance imaging (MRI) for their previous SRS\r\n             treatment planning\r\n\r\n          -  Patient must be able to complete the Functional and Quality of Life questionnaires in\r\n             English\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Significant cognitive or psychiatric symptoms that prevent the ability to complete a\r\n             physical exam, questionnaires, or participate in nTMS or EMG\r\n\r\n          -  Poor performance status Karnofsky performance score (KPS < 60) that prevents the\r\n             ability to participate in a physical exam, nTMS, or EMG. Patients will not be excluded\r\n             if they are not able to complete the exploratory EEG analysis\r\n\r\n          -  Patients receiving any prior treatment that might impact their cognitive, psychiatric,\r\n             or motor cortex function\r\n      ","sponsor":"M.D. Anderson Cancer Center","sponsor_type":"Other","conditions":"Metastatic Malignant Neoplasm in the Brain|Radiation Therapy Recipient","interventions":[{"intervention_type":"Other","name":"Other: Quality-of-Life Assessment","description":"Ancillary studies"},{"intervention_type":"Other","name":"Other: Questionnaire Administration","description":"Ancillary studies"},{"intervention_type":"Behavioral","name":"Behavioral: Hand Function Test","description":"Complete tasks that test grip strength, pinch strength, and ability to use and feel with hands"},{"intervention_type":"Procedure","name":"Procedure: Navigated Transcranial Magnetic Stimulation","description":"Undergo nTMS"}],"outcomes":[{"outcome_type":"primary","measure":"Operational feasibility of navigated transcranial magnetic stimulation (nTMS)","time_frame":"Up to 1 year","description":"Will be determined to be operationally feasible on a patient if the images and data obtained from nTMS for the patient provide useful information to the radiation oncologist and if the radiation oncologist determines that this additional information would improve patient care. Will deem the use of nTMS to be operationally feasible overall if it is deemed operationally feasible on an underlying proportion of at least 90% potentially consented patients. Will calculate the proportions of operational and technical feasibility of the use of nTMS and their 80% confidence intervals (CIs). If the observed proportions are greater than or equal to 82%, the use of nTMS to be operationally and technically will be deemed feasible."},{"outcome_type":"primary","measure":"Technical feasibility of nTMS","time_frame":"Up to 1 year","description":"Will be determined to be technically feasible on a patient if the procedure of nTMS is able to be performed on the patient, resulting in mapped motor cortex data. If the patient is not able to complete the procedure for any reason, that patient's nTMS treatment will not be technically feasible. Will deem the use of nTMS to be technically feasible overall if it is deemed technically feasible on an underlying proportion of at least 90% potentially consented patients. Will calculate the proportions of operational and technical feasibility of the use of nTMS and their 80% CIs. If the observed proportions are greater than or equal to 82%, the use of nTMS to be operationally and technically will be deemed feasible."},{"outcome_type":"primary","measure":"Economic feasibility of nTMS","time_frame":"Up to 1 year","description":"Will be determined to be economically feasible if there are no additional costs to the patients and department, other than those outlined in the proposed budget."},{"outcome_type":"primary","measure":"Identification of the motor cortex by addition of nTMS","time_frame":"Up to 1 year","description":"The treating radiation oncologist will determine if the use of nTMS provides additional information over the standard atlas-based definition of the motor region if they state that they would have made adjustments to their treatment volume of the tumor based on the new nTMS data provided."},{"outcome_type":"secondary","measure":"Stereotactic radiosurgery (SRS) dosimetry and lesion involvement in the motor tracts","time_frame":"Up to 1 year","description":"The relationship will be identified using nTMS. Dose volume histogram data for the motor cortex and motor tracts will be generated."},{"outcome_type":"secondary","measure":"Presence or absence of motor deficits","time_frame":"Up to 1 year","description":"Will be determined by the Manual Ability Measure-20, Euroqol-5 Dimensional-5 Level, and MD Anderson Symptom Inventory - Brain Tumor questionnaires. Data analyses will be performed to determine correlations between objective/subjective deficits (based on the results of the questionnaires) and dose volume histogram data for the motor cortex and tracts."},{"outcome_type":"secondary","measure":"Production of viable internal control by contralateral motor tract, accounting for handedness","time_frame":"Up to 1 year"},{"outcome_type":"secondary","measure":"Development of a clinical trial that will limit radiation dose to brain metastases","time_frame":"Up to 1 year","description":"Will determine if trial can aid in the design of a prospective, randomized clinical trial that will limit radiation dose to brain metastases located in close proximity to the motor cortex with the goal of improving functional and quality of life outcomes based on meeting the primary objective of this study."},{"outcome_type":"secondary","measure":"Utility of electroencephalography (EEG)","time_frame":"Up to 1 year","description":"The utility of EEG in correlation with nTMS and reported functional outcomes will be explored."}]}
{"nct_id":"NCT04007588","start_date":"2019-09-06","phase":"Phase 2","enrollment":0,"brief_title":"A Phase II Trial of Neoadjuvant Treatment With PD-1 Inhibition (Nivolumab) With or Without IDO Inhibition (BMS-986205) and With or Without CTLA-4 Inhibition (Ipilimumab) in Resectable Stage III or IV Melanoma","official_title":"A Phase II Trial of Neoadjuvant Treatment With PD-1 Inhibition (Nivolumab) With or Without IDO Inhibition (BMS-986205) and With or Without CTLA-4 Inhibition (Ipilimumab) in Resectable Stage III or IV Melanoma","primary_completion_date":"2019-12-19","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2019-12-19","last_update":"2020-02-05","description":"This research study is studying different immunotherapy regimens as a possible treatment for stage III or IV resectable melanoma.","other_id":"19-043","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologic or cytologic diagnosis of resectable stage III or IV cutaneous melanoma.\r\n             Patients with melanoma of mucosal origin are not eligible. Patients with acral\r\n             melanoma that fit criteria are eligible. Patients must have clinically detectable\r\n             stage III (clinically detectable N1b, N1c, N2b, N2c, N3b or N3c) or stage IV\r\n             resectable melanoma.\r\n\r\n          -  Age  18 years.\r\n\r\n          -  ECOG performance status 2 (Karnofsky 60%, see Appendix A)\r\n\r\n          -  Participants must have normal organ and marrow function as defined below:\r\n\r\n               -  leukocytes 2,000/mcL\r\n\r\n               -  absolute neutrophil count 1,500/mcL\r\n\r\n               -  platelets 100,000/mcL\r\n\r\n               -  hemoglobin 9.0g/dL\r\n\r\n               -  total bilirubin within normal institutional limits\r\n\r\n               -  AST(SGOT)/ALT(SGPT) 2.5  institutional upper limit of normal\r\n\r\n               -  creatinine within normal institutional limits OR\r\n\r\n               -  creatinine clearance 40 mL/min/1.73 m2 for participants with creatinine levels\r\n                  above institutional normal.\r\n\r\n               -  C-Reactive Protein < institutional ULN\r\n\r\n          -  Quantitative or qualitative G6PD assay results must not suggest underlying G6PD\r\n             deficiency\r\n\r\n          -  Measurable disease (by CT, PET/CT or MRI)\r\n\r\n          -  Prior therapies including targeted therapy and immunotherapy are not allowed, with the\r\n             exception of adjuvant Ipilimumab or Interferon--2b.\r\n\r\n          -  Ability to understand and the willingness to sign a written informed consent document.\r\n\r\n          -  Ability to swallow pills intact and without GI issues which may impact medication\r\n             absorption.\r\n\r\n          -  Women of childbearing potential (WOCBP) must agree to follow instructions for\r\n             method(s) of contraception (Refer to Appendix B) for the duration of treatment with\r\n             study treatment(s) plus 5 months post-treatment completion (i.e. 30 days plus the time\r\n             required for nivolumab to undergo approximately 5 half-lives).\r\n\r\n          -  Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy\r\n             test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to\r\n             the start of study treatment.\r\n\r\n          -  Males who are sexually active with WOCBP must agree to follow instructions for\r\n             method(s) of contraception for the duration of treatment with study treatment(s) plus\r\n             7 months post-treatment completion (i.e. 90 days plus the time required for nivolumab\r\n             to undergo approximately 5 half-lives). In addition, male participants must be willing\r\n             to refrain from sperm donation during this time. This criterion applies to azoospermic\r\n             males as well.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  A history of prior treatment with PD-1 inhibitor, CTLA-4 inhibitor or IDO inhibition.\r\n             Prior therapy with ipilimumab or Interferon--2b in the adjuvant setting is permitted.\r\n             Participants may not have received live/attenuated vaccines within 30 days of first\r\n             treatment.\r\n\r\n          -  Participants with uveal or mucosal melanoma\r\n\r\n          -  Participants with known brain metastases must have documented stability for at least\r\n             30 days directly prior to study enrollment and not be requiring active treatment for\r\n             these. Prior radiation, surgery and stereotactic radiosurgery are allowed but must be\r\n             completed four weeks prior to initiating therapy.\r\n\r\n          -  History of allergic reactions attributed to compounds of similar chemical or biologic\r\n             composition to nivolumab, ipilimumab, methylene blue or BMS-986205. History or\r\n             presence of hypersensitivity or idiosyncratic reaction to methylene blue.\r\n\r\n          -  Need for systemic steroids at the time of enrollment. Physiologic replacements at a\r\n             dose of less than 10 mg daily prednisone equivalent is allowed.\r\n\r\n          -  Blood Methemoglobin > ULN, assessed in an arterial or venous blood sample or by\r\n             co-oximetry\r\n\r\n          -  Participants with active ILD/pneumonitis or history of ILD/ pneumonitis requiring\r\n             steroids.\r\n\r\n          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active\r\n             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac\r\n             arrhythmia, or psychiatric illness/social situations that would limit compliance with\r\n             study requirements.\r\n\r\n          -  Pregnant women are excluded from this study because there is an unknown but potential\r\n             risk for adverse events in nursing infants secondary to treatment of the mother with\r\n             nivolumab or BMS-986205, breastfeeding should be discontinued if the mother is treated\r\n             with nivolumab or BMS-986205. These potential risks may also apply to other agents\r\n             used in this study.\r\n\r\n          -  Known active HIV, Hepatitis B or Hepatitis C patients. HIV-positive participants on\r\n             combination antiretroviral therapy are ineligible because of the potential for an\r\n             immunologic effect with the therapy. Appropriate studies will be undertaken in\r\n             participants receiving combination antiretroviral therapy when indicated.\r\n\r\n          -  Autoimmune disease that requires treatment at the time of enrollment. Participants\r\n             with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin\r\n             disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment\r\n             or conditions not expected to recur in the absence of an external trigger are\r\n             permitted to enroll.\r\n\r\n          -  Participant with a personal or family (ie, in a first-degree relative) history of\r\n             cytochrome b5 reductase deficiency (previously called methemoglobin reductase\r\n             deficiency) or other diseases that put them at risk of methemoglobinemia. All\r\n             participants will be screened for methemoglobin levels prior to randomization.\r\n\r\n          -  Participant with a history of G6PD deficiency or other congenital or autoimmune\r\n             hemolytic disorders. All participants will be screened for G6PD levels prior to\r\n             randomization.\r\n\r\n          -  Participants must not have a history of life-threatening toxicity related to prior\r\n             immune therapy (eg. anti-CTLA-4 or any other antibody or drug specifically targeting\r\n             T-cell co-stimulation or immune checkpoint pathways) except those that are unlikely to\r\n             re-occur with standard countermeasures (eg. hormone replacement after adrenal crisis).\r\n\r\n          -  Treatment with botanical preparations (eg, herbal supplements or traditional Chinese\r\n             medicines) intended for general health support or to treat the disease under study\r\n             within 2 weeks prior to randomization.\r\n\r\n          -  History of other malignancy within 3 years prior to screening, with the exception of\r\n             those with a negligible risk of metastasis or death (e.g., 5-year OS of > 90%), such\r\n             as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma,\r\n             localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.\r\n\r\n          -  Participants who have had major surgery requiring general anesthesia or significant\r\n             trauma who have not recovered per physician determination for at least 14 days prior\r\n             to randomization.\r\n\r\n          -  Participants with conditions known to interfere significantly with the absorption of\r\n             oral medication, as per investigator judgment.\r\n\r\n          -  Participants with uncontrolled adrenal insufficiency.\r\n\r\n          -  Prior history of serotonin syndrome.\r\n      ","sponsor":"Dana-Farber Cancer Institute","sponsor_type":"Other","conditions":"Melanoma Stage III|Melanoma Stage IV","interventions":[{"intervention_type":"Drug","name":"Drug: Nivolumab","description":"Nivolumab is a types of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells. Nivolumab work by stopping various molecules on cancer cells and body cells from working against the immune system's natural fight against cancer"},{"intervention_type":"Drug","name":"Drug: BMS-986205","description":"BMS-986205 is a types of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells. BMS-986205 work by stopping various molecules on cancer cells and body cells from working against the immune system's natural fight against cancer"},{"intervention_type":"Drug","name":"Drug: Ipilimumab","description":"Ipilimumab is a types of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells. Ipilimumab work by stopping various molecules on cancer cells and body cells from working against the immune system's natural fight against cancer"}],"outcomes":[{"outcome_type":"primary","measure":"Major Pathologic Response Rate","time_frame":"2 years","description":"Complete Pathological response rate or near pathological complete response rate on each treatment arm"},{"outcome_type":"secondary","measure":"Recurrence free survival","time_frame":"2 years","description":"Time from treatment start to recurrence of melanoma"},{"outcome_type":"secondary","measure":"Overall Survival Rate","time_frame":"2 years","description":"Time from treatment start to death"},{"outcome_type":"secondary","measure":"Changes In Infiltrating immune cells From Pre-Treatment To Time Of Excision","time_frame":"2 Years","description":"Changes in immune cells in the tumor micro environment including CD8 T-cells"},{"outcome_type":"secondary","measure":"Rates of adverse events and serious adverse events on the different treatment arms.","time_frame":"2 years","description":"Rates of different grade adverse events on each treatment arm"}]}
{"nct_id":"NCT03892369","start_date":"2019-09-01","phase":"N/A","enrollment":45,"brief_title":"FGF21 and Its Role in Alcohol Dependence","official_title":"Physiological Effects of FGF21 in Humans and Its Pathophysiological Role in Alcohol Dependence","primary_completion_date":"2021-06-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-03-01","last_update":"2021-03-18","description":"Plasma fibroblast growthfactor-21 (FGF21) responses to acute alcohol exposure will be evaluated in three groups: A: 15 individuals diagnosed with alcohol dependence (ICD10 code F10.2) and no alcoholic liver diseases, B: 15 healthy individuals with one or two parents with alcohol dependence, and C: 15 healthy matched controls without history of or disposition to alcohol dependence. The experimental day consists of a load of 0.5 g ethanol per kg body weight ingested from time 0-10 minutes followed by a 7 h period in which blood will be sampled with frequent intervals, rating of preference for ethanol, salt, sour, bitterly and sweets, sensations of hunger, appetite, satiety, headache, and nausea will be evaluated using visuel analogue scale and resting energy expenditure will be evaluated using indirect calorimetry.","other_id":"H-18063495","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","intervention_model_description":"Three matched groups. Group A: participants diagnosed with alcohol dependence, group B: participants with a father diagnosed with alcohol dependence, and C: a healthy control group.","sampling_method":"","gender":"Male","minimum_age":25,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Informed consent\r\n\r\n          -  Caucasian males between 25 and 65 years of age\r\n\r\n          -  BMI between 19 and 27 kg/m2\r\n\r\n          -  Normal haemoglobin\r\n\r\n          -  Normal fasting plasma glucose concentration (< 6 mmol/l) and normal glycated\r\n             haemoglobin A1c (HbA1c) (< 42 mmol/mol)\r\n\r\n        Participants with a father diagnosed with alcohol dependence (group B):\r\n\r\n          -  Father diagnosed with alcohol dependence\r\n\r\n          -  Weekly alcohol intake of less than 14 units of alcohol (of 12 g)\r\n\r\n          -  Normal Alcohol Use Disorders Identification Test (AUDIT) score\r\n\r\n        Healthy participants (group C):\r\n\r\n          -  Weekly alcohol intake of less than 14 units of alcohol (of 12 g)\r\n\r\n          -  Normal AUDIT score\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Liver disease evaluated by plasma alanine aminotransferase (ALAT) > 3  normal level,\r\n             an international normalised ratio (INR) below normal values, or biopsy-verified\r\n             alcoholic liver disease\r\n\r\n          -  Diabetes mellitus\r\n\r\n          -  Anaemia\r\n\r\n          -  Nephropathy\r\n\r\n          -  Other diseases the investigator finds disruptive for participation in the study.\r\n\r\n        Participants with a father diagnosed with alcohol dependence (group B):\r\n\r\n        - Former alcohol dependence or abuse\r\n\r\n        Healthy participants (group C):\r\n\r\n          -  First-degree relatives with diabetes, liver disease and/or alcohol dependence\r\n\r\n          -  Former alcohol dependence\r\n      ","sponsor":"University Hospital, Gentofte, Copenhagen","sponsor_type":"Other","conditions":"Alcohol Abuse or Dependence","interventions":[{"intervention_type":"Other","name":"Other: Ethanol","description":"Ethanol administration"}],"outcomes":[{"outcome_type":"primary","measure":"Fibroblast growthfactor-21","time_frame":"One year","description":"Plasma FGF21 concentrations, a member of the endocrine FGF-family"},{"outcome_type":"secondary","measure":"Ethanol","time_frame":"One year","description":"Plasma ethanol concentration"},{"outcome_type":"secondary","measure":"Glucose","time_frame":"One year","description":"Plasma glucose concentrations"},{"outcome_type":"secondary","measure":"Insulin and C-peptide","time_frame":"One year","description":"Serum insulin and C-peptide concentrations"},{"outcome_type":"secondary","measure":"Glucagon","time_frame":"One year","description":"Plasma glucagon concentration"},{"outcome_type":"secondary","measure":"Tumor Necrosis Factor-alpha (TNF)","time_frame":"One year","description":"Plasma TNF-alpha concentrations"},{"outcome_type":"secondary","measure":"Lipopolysaccharide Binding Protein (LBP)","time_frame":"One year","description":"Plasma LBP concentrations"},{"outcome_type":"secondary","measure":"Interferon-gamma (INF)","time_frame":"One year","description":"Plasma INF-gamma concentrations"},{"outcome_type":"secondary","measure":"Interleukine-10 (IL-10)","time_frame":"One year","description":"Plasma IL-10 concentrations"},{"outcome_type":"secondary","measure":"Interleukine-8 (IL-8)","time_frame":"One year","description":"Plasma IL-8 concentrations"},{"outcome_type":"secondary","measure":"Interleukine-6 (IL-6)","time_frame":"One year","description":"Plasma IL-6 concentrations"}]}
{"nct_id":"NCT03997656","start_date":"2019-09-01","phase":"N/A","enrollment":100,"brief_title":"A Digital Therapy for Diabetes Prevention Among Overweight Adults in Terengganu, Malaysia","official_title":"A Randomised Controlled Trial of a Digital Therapy for Diabetes Prevention","primary_completion_date":"2020-05-01","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2021-07-01","last_update":"2019-07-15","description":"The modern world revolves around technology; unsurprisingly companies are leveraging the expertise of the digital tech industry to aid in the prevention of chronic diseases. Among one of the most common chronic diseases in Malaysia is diabetes. Prevalence of diabetes in Malaysia has increased by more than two folds over the past two decades. Despite a growing number of tech products developments on diabetes prevention, a recent meta-analysis has found almost no evidence on digital therapy outside the developed world. Therefore, this study is needed to demonstrate the potential of digital therapy in preventing diabetes in Malaysia. The study design is a randomized controlled trial study conducted in Kuala Terengganu, Malaysia. The study will be conducted in two phases. The first phase will involve preparation of intervention modules and development of intervention mobile app. The second phase will involve validation and utilization of the digital therapy. We hope that this digital therapy program can make a significant difference in health outcomes, especially for diabetes. By giving precise regimes and daily monitoring, digital therapeutics can offer mountains of data that can potentially provide doctors unprecedented insights into patient behavior and create feedback or optimization loops for individual patients. Enabling patients to take greater control over managing their chronic illnesses and preventing disease progression could save billions of ringgits throughout the entire Malaysia healthcare system. By that, we hope this approach can be considered as a scalable solution to address national diabetes prevention efforts to target of improvement on diabetes prevalence to not more than 15% by 2025 and serve as a model for applying such services to other chronic diseases.","other_id":"2018/77","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","intervention_model_description":"Control group","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  aged 18-65 years old\r\n\r\n          -  body mass index (BMI) of 23 kg/m2,\r\n\r\n          -  high risk for diabetes (diabetes risk test score 5 [22] or HbA1c of 38-44 mmol/mol or\r\n             5.6-6.2%\r\n\r\n          -  ownership of a smartphone (Android only) for communication defined as logging on at\r\n             least once/day to the internet\r\n\r\n          -  being fluent in Malay or English languages and\r\n\r\n          -  had no contradictions to participate in weight management program or physical\r\n             activity.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  clinical history of diabetes or newly diagnosed diabetes at the time of screening\r\n             where HbA1c level 45 mmol/mol or 6.3%\r\n\r\n          -  taking oral anti-diabetic agents\r\n\r\n          -  participating in a concurrent weight management program or interventional research\r\n             protocol\r\n\r\n          -  on a prescribed medical diet, anti-obesity or diabetes therapy within the preceding 4\r\n             months\r\n\r\n          -  had clinical history of cardiovascular diseases occurred within the past 6 months\r\n\r\n          -  any form of cancers that require treatment\r\n\r\n          -  dementia or probable Alzheimer's disease\r\n\r\n          -  advanced arthritis\r\n\r\n          -  pregnant or within 6 weeks of having given birth or planning to become pregnant in the\r\n             next 12 months\r\n\r\n          -  existing liver and renal disease and having hyperthyroidism\r\n\r\n          -  any mental health condition including eating disorder or alcohol/substance use\r\n\r\n          -  other causes which could interfere with participation (for examples physically\r\n             disabled)\r\n      ","sponsor":"Universiti Sultan Zainal Abidin","sponsor_type":"Other","conditions":"Pre Diabetes|Overweight and Obesity","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: MyDiPP (Malaysia Diabetes Prevention Program)","description":"The participants will go through 16-weekly core lessons that need to be completed within the first 24 weeks after randomisation focusing on changing dietary habits, increase physical activity and relapse prevention and 6-monthly post-core lessons focusing on maintenance of lifestyle habits and weight loss achieved during the core program."},{"intervention_type":"Other","name":"Other: usual care","description":"standard health education from primary care providers in the clinic"}],"outcomes":[{"outcome_type":"primary","measure":"body weight","time_frame":"6-months and 12-months","description":"change of the initial body weight by 5% to 7%"},{"outcome_type":"secondary","measure":"HbA1c level","time_frame":"6-months and 12-months","description":"HbA1c level will be tested using A1CNow+ test kit from a finger-stick blood samples collected in a capillary tube according to the manufacturer's procedure guidelines. To measure HbA1c with A1cNow+ test kit, the finger will be cleaned with alcohol swab, allowed to dry and then lanced with sterile lancet to obtain a drop of blood. A 5µl capillary blood sample will be collected and added to the sample dilution buffer. The diluted sample will be mixed and added to the monitoring using transfer pipette. Once the sample was applied, the monitor will begin the analyses. Digital results will be displayed in the display window after 5 minutes. The test result will be recorded for each participant."},{"outcome_type":"secondary","measure":"physical activity level","time_frame":"6-months and 12-months","description":"Physical activity (PA) will be assessed using translated and validated version of short-form International Physical Activity Questionnaire (IPAQ short form). It comprises of seven items that identify frequency and time spent on three specific types of physical activity (walking, moderate intensity activity, and vigorous intensity activity) during the past seven days. The Metabolic Equivalent (MET) values will be measured. The subjects' total physical activity (MET-minutes/week) will be calculated by summing up the walking, moderate and vigorous intensity activity scores. Subjects will be categorised as \"active\" if they achieved ≥600 MET-minutes/week, \"moderately active\" if they achieved ≥150 MET-minutes/week and \"inactive\" if they achieved <150 MET-minutes/week."},{"outcome_type":"secondary","measure":"dietary intake","time_frame":"6-months and 12-months","description":"The dietary intake status of the participants will be assessed from their food diary record from the app and the diary for intervention and control participants respectively. Participants will be asked to record their dietary intake for three days (two weekdays and one weekend) and the average measurement will be taken. A dietary analysis software, Nutritionist Pro Inc. will be used for energy and nutrient analysis."},{"outcome_type":"secondary","measure":"health-related quality of life","time_frame":"6-months and 12-months","description":"HRQoL will be assessed using translated and validated version of SF-36 health survey questionnaire. It comprises of 36 items which measure eight health domains which are physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotion (RE) and mental health (MH). The eight domains will be scored from 0 to 100 indicating worst to best possible health. All the scores will be further summarised into the Physical Component Summary score (PCS) and the Mental Component Summary score (MCS)."}]}
{"nct_id":"NCT04348136","start_date":"2019-09-01","phase":"Phase 2/Phase 3","enrollment":27,"brief_title":"An Extension Study of JR-141 in Patients With Mucopolysaccharidosis II","official_title":"An Extension Study of JR-141-301 in Patients With Mucopolysaccharidosis II","primary_completion_date":"2030-03-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2030-03-31","last_update":"2021-02-02","description":"Multicenter, open-label, single-group, designed to evaluate the long term efficacy and safety of study drug for the treatment of the MPS II.","other_id":"JR-141-302","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patients who will have completed clinical trial JR-141-301 and judged by the\r\n             investigator or subinvestigator to be able to participate in the study from safety\r\n             aspects.\r\n\r\n          2. Capable of providing written consent by himself, unless the patient is under the age\r\n             of 20 years at the time of informed consent process, or it is not possible to obtain\r\n             consent from the patient himself due to his intellectual disabilities associated with\r\n             MPS II.\r\n\r\n          3. In the case of a patient who is under the age of 20 years or from whom it is not\r\n             possible to obtain consent due to his intellectual disabilities associated with MPS\r\n             II, he may be included if written consent can be provided by legal representative;\r\n             however written consent should be obtained from the patient himself too, wherever\r\n             possible.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Judged by the investigator or subinvestigator to be ineligible to participate in the\r\n             study due to receive concomitant therapy which affectseffect the clinical evaluation.\r\n\r\n          2. Judged by the investigator or subinvestigator to be ineligible to participate in the\r\n             study due to a history of a serious drug allergy or sensitivity.\r\n\r\n          3. Otherwise judged by the investigator or subinvestigator to be ineligible to\r\n             participate in the study.\r\n      ","sponsor":"JCR Pharmaceuticals Co., Ltd.","sponsor_type":"Industry","conditions":"Mucopolysaccharidosis II","interventions":[{"intervention_type":"Drug","name":"Drug: JR-141","description":"IV infusion, 2.0 mg/kg/week"}],"outcomes":[{"outcome_type":"primary","measure":"Number of participants with Adverse Events","time_frame":"up to approximately 3 years","description":"• Routine laboratory tests in blood (hematology, liver function, renal function, iron-related levels) and urine (urinalysis)Infusion Associated Reaction (IAR)"},{"outcome_type":"secondary","measure":"Change From the first dose of the previous study (JR-141-301) in Serum Heparan Sulfate Levels.","time_frame":"78, 104, 130 weeks,the end of the study*"},{"outcome_type":"secondary","measure":"Change From the first dose of the previous study (JR-141-301) in Serum Dermatan Sulfate Levels.","time_frame":"78, 104, 130 weeks,the end of the study*"},{"outcome_type":"secondary","measure":"Change From the first dose of the previous study (JR-141-301) in Urinary Heparan Sulfate Levels.","time_frame":"78, 104, 130 weeks,the end of the study*"},{"outcome_type":"primary","measure":"Number of participants with Adverse Events","time_frame":"up to approximately 3 years","description":"Adverse events"},{"outcome_type":"primary","measure":"Number of participants with Adverse Events","time_frame":"up to approximately 3 years","description":"Antidrug antibodiesLaboratory tests (hematologic test, blood biochemical test, determination of iron-related levels and urine analysis)"},{"outcome_type":"primary","measure":"Number of participants with Adverse Events","time_frame":"up to approximately 3 years","description":"Vital signs (pulse rate, body temperature, and blood pressure,Blood pressures in mmHg,Heart rate in beats/minute,Respiratory rate in breaths/minute,Temperature in °C,Presence or absence of abnormalities for physical examination"},{"outcome_type":"primary","measure":"Number of participants with Adverse Events","time_frame":"up to approximately 3 years","description":"Presence or absence of abnormalities for 12-lead electrocardiogram"},{"outcome_type":"primary","measure":"Number of participants with Adverse Events","time_frame":"up to approximately 3 years","description":"Antibody tests"},{"outcome_type":"secondary","measure":"Change From the first dose of the previous study (JR-141-301) in Urinary Dermatan Sulfate Levels.","time_frame":"78, 104, 130 weeks,the end of the study*"},{"outcome_type":"secondary","measure":"Change From the first dose of the previous study (JR-141-301) in Liver Volumes.","time_frame":"78, 104, 130 weeks,the end of the study*"},{"outcome_type":"secondary","measure":"Change From the first dose of the previous study (JR-141-301) in Spleen Volumes.","time_frame":"78, 104, 130 weeks,the end of the study*"},{"outcome_type":"secondary","measure":"Change From Baseline in Echocardigraphy","time_frame":"78, 104, 130 weeks,the end of the study*"},{"outcome_type":"secondary","measure":"Change From the first dose of the previous study (JR-141-301) in 6-minute Walk Test Distance.","time_frame":"104 weeks, the end of the study*","description":"Item 9 will be administrated only in patients judged by the investigator or subinvestigator to be possible to perform the 6-minutes walk test."},{"outcome_type":"secondary","measure":"Change From the first dose of the previous study (JR-141-301) in Joint Range of Motion (goniometer)","time_frame":"104, 130 weeks, the end of the study*"},{"outcome_type":"secondary","measure":"Change From the first dose of the previous study (JR-141-301) in Heparan Sulfate Levels in Cerebrospinal Fluid.","time_frame":"104 weeks, the end of the study*"},{"outcome_type":"secondary","measure":"Change From the first dose of the previous study (JR-141-301) in Dermatan Sulfate Levels in Cerebrospinal Fluid.","time_frame":"104 weeks, the end of the study*"},{"outcome_type":"secondary","measure":"Change From the first dose of the previous study (JR-141-301) in Neurocognitive Testing (Kyoto Scale of Psychological Development 2001)","time_frame":"104 weeks, the end of the study*"},{"outcome_type":"secondary","measure":"Change From the first dose of the previous study (JR-141-301) in Adaptive Behavioral Testing ( Vineland Adaptive Behavior Scales Second Edition. )","time_frame":"104 weeks, the end of the study*"},{"outcome_type":"secondary","measure":"Change From the first dose of the previous study (JR-141-301) in Cognitive Testing (Bayley Scales of Infant and Toddler Development, Third Edition. )","time_frame":"104 weeks, the end of the study*"},{"outcome_type":"secondary","measure":"Change From the first dose of the previous study (JR-141-301) in Cognitive Testing (Kaufman Assessment Battery for Children, Second Edition)","time_frame":"104 weeks, the end of the study*","description":"*Target patients: Patients who haven't conducted the test for more than 26 weeks."}]}
{"nct_id":"NCT04055155","start_date":"2019-09-01","enrollment":12,"brief_title":"Technology-enabled Task-sharing for Depression in Primary Care","official_title":"Discovering the Capacity of Primary Care Frontline Staff to Deliver a Low-Intensity Technology-Enhanced Intervention to Treat Geriatric Depression","primary_completion_date":"2020-07-01","study_type":"Observational","rec_status":"Unknown status","completion_date":"2020-08-31","last_update":"2019-08-22","description":"This study will explore and test the feasibility, acceptability, usability, and preliminary effectiveness of a technology-enabled intervention for depression using task-sharing in primary care. We will a) discover barriers and facilitators to task-sharing by frontline primary care staff; b) design an implementation strategy to support task-sharing to deliver a technology-enabled intervention for depression; and c) conduct a small open-label usability trial of the technology-enabled intervention for depression.","other_id":"STUDY00006748","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":60,"population":"Primary care clinics: administrators, primary care providers, behavioral health providers,\r\n        frontline primary care staff (e.g., nurses, medical assistants)\r\n\r\n        Patients: older adult primary care patients with mild-to-moderate depressive symptoms","criteria":"\n        Inclusion Criteria:\r\n\r\n        Clinics:\r\n\r\n          1. have at least 1 full-time registered nurse (RN) and/or medical assistant (MA) on staff\r\n\r\n          2. include older adults on their patient panels.\r\n\r\n        Clinic administrators\r\n\r\n          1. have an administrative or leadership role in the clinic\r\n\r\n          2. have been employed in their current role for at least 6 months.\r\n\r\n        Frontline staff\r\n\r\n          1. provide care as RN, MA, case manager, behavioral health consultant, or similar role\r\n             identified by Practice Champion\r\n\r\n          2. be employed at the participating clinic for at least 6 months.\r\n\r\n        Patients\r\n\r\n          1. be 65 years of age\r\n\r\n          2. report moderate to moderately severe depressive symptoms based on a PHQ-9 score of\r\n             10-20\r\n\r\n          3. own or have access to a smartphone\r\n\r\n          4. have internet or cellular data plan\r\n\r\n          5. receive medical clearance from their primary care provider to participate in\r\n             unstructured physical activity.\r\n\r\n        Patient exclusion criteria will be based on medical chart review by Practice Champion and\r\n        include:\r\n\r\n          1. current suicidality\r\n\r\n          2. severe vision or hearing impairment\r\n\r\n          3. pronounced cognitive impairment\r\n\r\n          4. use of assistive devices that would impede physical activity.\r\n      ","sponsor":"University of Washington","sponsor_type":"Other","conditions":"Depression|Depression in Old Age","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Usability (system usability scale)","time_frame":"after 2 week usability trial","description":"usability of MPATI intervention among provider end-users"},{"outcome_type":"primary","measure":"Usability (qualitative interviews)","time_frame":"after 2 week usability trial","description":"usability of MPATI intervention among provider end-users"},{"outcome_type":"secondary","measure":"feasibility -- patient recruitment","time_frame":"end of pilot trial (2 weeks per patient)","description":"feasibility of MPATI intervention for geriatric depression in primary care"},{"outcome_type":"secondary","measure":"acceptability -- patient retention","time_frame":"end of pilot trial (2 weeks per patient)","description":"acceptability of MPATI intervention for geriatric depression in primary care"},{"outcome_type":"secondary","measure":"depressive symptoms (patient)","time_frame":"pre-post 2 week pilot trial","description":"Patient Health Questionnaire (PHQ-9) total scores to assess depressive symptoms (total score range 0-27; higher scores reflect greater depressive symptoms)"},{"outcome_type":"secondary","measure":"functioning (patient)","time_frame":"pre-post 2 week pilot trial","description":"Sheehan Disability Scale (SDS) total scores to assess functional impairment; total scores range from 0 (unimpaired) to 30 (highly impaired)."},{"outcome_type":"other","measure":"user burden","time_frame":"end of 2 week pilot trial","description":"user burden of technology-enabled intervention for patients and providers"}]}
{"nct_id":"NCT03736317","start_date":"2019-09-01","phase":"N/A","enrollment":144,"brief_title":"Transcranial Magnetic Stimulation for Treatment of Methamphetamine Use Disorder","official_title":"Evaluation of the Effect of Repetitive Transcranial Magnetic Stimulation in Craving in Methamphetamine Use Disorder","primary_completion_date":"2021-02-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2021-09-01","last_update":"2021-09-16","description":"Repetitive transcranial magnetic stimulation (rTMS) was used to treat methamphetamine use disorder in previous studies, while the evidence-based protocols still required. The aim of this research is to develop more applicable rTMS intervention pattern and protocols to reduce craving and relapse of methamphetamine-dependent patients.","other_id":"MZhao-009","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)\r\n             for methamphetamine (MA) use disorders\r\n\r\n          -  Primary school degree or above\r\n\r\n          -  Normal vision and hearing\r\n\r\n          -  Dextromanual\r\n\r\n          -  Less than one month before last drug use\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Have a disease that affect cognitive function such as history of head injury,\r\n             cerebrovascular disease, epilepsy, etc\r\n\r\n          -  Have cognitive-promoting drugs in the last 6 months\r\n\r\n          -  Other substance abuse or dependence in recent five years (except nicotine)\r\n\r\n          -  Mental impairment, Intelligence Quotient (IQ) < 70\r\n\r\n          -  Mental disorders\r\n\r\n          -  Physical disease\r\n      ","sponsor":"Shanghai Mental Health Center","sponsor_type":"Other","conditions":"Amphetamine Use Disorders","interventions":[{"intervention_type":"Device","name":"Device: sham TBS","description":"Stimulate the dorsal lateral prefrontal cortex or medial prefrontal cortex for 2 weeks by sham Theta-burst stimulation (TBS), five times for a week with the sham coil."},{"intervention_type":"Device","name":"Device: real mPFC cTBS","description":"Stimulate the medial prefrontal cortex with the cTBS pattern. The therapy will be conducted for 2 weeks and five times for a week."},{"intervention_type":"Device","name":"Device: real dlPFC iTBS","description":"Stimulate the dorsal lateral prefrontal cortex with the iTBS pattern. The therapy will be conducted for 2 weeks and five times for a week."},{"intervention_type":"Device","name":"Device: real dlPFC iTBS + real mPFC cTBS","description":"Stimulate the dorsal lateral prefrontal cortex with the iTBS pattern, and stimulate medial prefrontal cortex with the cTBS pattern. The therapy will be conducted for 2 weeks and five times for a week."}],"outcomes":[{"outcome_type":"primary","measure":"Change of Craving assessed by Visual Analog Scale","time_frame":"12 months.","description":"evaluate all participants' craving for for methamphetamine assessed by Visual Analog Scales (VAS). Score of VAS range from 0 to 10, and higher values represent high level of craving."},{"outcome_type":"secondary","measure":"Number of participants who relapse","time_frame":"12 months","description":"Follow up with patients after discharge, evaluate number of participants who relapse"},{"outcome_type":"secondary","measure":"Depression status assessed by Patient Health Questionnaire-9(PHQ-9)","time_frame":"12 months","description":"evaluate all participants' depression status by Patient Health Questionnaire-9(PHQ-9), PHQ-9 range from 0 to 27, and higher values represent more severe level of depression."},{"outcome_type":"secondary","measure":"Anxiety status assessed by Generalized Anxiety Disorder Screener (GAD-7)","time_frame":"12 months","description":"evaluate all participants' anxiety status by Generalized Anxiety Disorder Screener (GAD-7). PHQ-9 range from 0 to 21, and higher values represent more severe level of anxiety."},{"outcome_type":"secondary","measure":"Cognitive function assessed by CogState Battery (CSB)","time_frame":"12 months","description":"evaluate all participants' cognitive function by the computerized CogState Battery (CSB) Chinese version"},{"outcome_type":"secondary","measure":"Response inhibition function","time_frame":"12 months","description":"assessed by Go nogo task under the electroencephalogram recording"},{"outcome_type":"secondary","measure":"Cue reactivity","time_frame":"12 months","description":"assessed by Cue reactivity task under the electroencephalogram recording"}]}
{"nct_id":"NCT03814928","start_date":"2019-09-01","phase":"N/A","enrollment":50,"brief_title":"Caregivers' Online Training for Recovery From Hip Fracture","official_title":"Recovery After Hip Fracture: A Novel Online Intervention for Caregivers","primary_completion_date":"2023-11-30","study_type":"Interventional","rec_status":"Enrolling by invitation","completion_date":"2023-11-30","last_update":"2021-04-27","description":"This project will test feasibility to deliver an online education and skill development program for family/caregivers of older adults recovering from a surgically repaired low-trauma hip fracture. We will also recruit health professionals to review and provide feedback on the e-learning course before we test its feasibility and acceptability with caregivers.","other_id":"H18-01409","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":19,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Family/caregivers of old adults with hip fracture\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Adults less than 19 years of age\r\n      ","sponsor":"University of British Columbia","sponsor_type":"Other","conditions":"Hip Fractures|Family","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Caregivers e-Learning Course","description":"Investigators will request that family/caregivers watch a self-paced (60-90 minutes) online e-learning training session for recovery after hip fracture."}],"outcomes":[{"outcome_type":"primary","measure":"Course acceptability","time_frame":"assessing change before and immediately after taking the short online course, and 3 months later","description":"Participants will be asked to rate (using a Likert scale 1 to 7) perceptions of acceptability of the (1) delivery mode and (2) program."},{"outcome_type":"primary","measure":"Course feasibility to deliver","time_frame":"assessing change before and immediately after taking the short online course, and 3 months later","description":"Participants will be asked to rate (using a Likert scale 1 to 7) perceptions of feasibility of the (1) delivery mode and (2) program."},{"outcome_type":"primary","measure":"Feedback on Course: usability","time_frame":"assessing change before and immediately after taking the short online course, and 3 months later","description":"Questionnaires will assess participants' perceptions on technology usability (Unified Theory of Acceptance and Use of Technology)."},{"outcome_type":"primary","measure":"Feedback on Course: self-efficacy","time_frame":"assessing change before and immediately after taking the short online course, and 3 months later","description":"Questionnaires will assess participants' perceptions of self-efficacy (Modified Computer Self-Efficacy Scale) for using a computer and the online program."},{"outcome_type":"primary","measure":"Caregivers' Online Course Quiz","time_frame":"assessing change before and immediately after taking the short online course, and 3 months later","description":"A quiz based on the information contained within the program will be administered."},{"outcome_type":"primary","measure":"Caregivers' Online Course semi-structured interviews","time_frame":"immediately after the intervention and 3 months later","description":"A sub-sample of 20 caregivers (within 1 week of the intervention and 3 months later) will be invited to take part in semi-structured interviews by telephone to ask questions about program and delivery acceptability (including technology use) and the effect of caregiving on their everyday activities and health."},{"outcome_type":"secondary","measure":"Berlin Social Support Scale","time_frame":"baseline and 3 months later"},{"outcome_type":"secondary","measure":"Brief Pain Inventory","time_frame":"baseline and 3 months later"},{"outcome_type":"secondary","measure":"Caregiving Self-efficacy Scale","time_frame":"baseline and 3 months later"},{"outcome_type":"secondary","measure":"Caregiver Strain Index","time_frame":"baseline and 3 months later"},{"outcome_type":"secondary","measure":"Functional Outcomes of Sleep Questionnaire (Short Form)","time_frame":"baseline and 3 months later"},{"outcome_type":"secondary","measure":"Physical activity with a self-report questionnaire, the Community Healthy Activities Model Program for Seniors (CHAMPS)","time_frame":"baseline and 3 months later"},{"outcome_type":"secondary","measure":"EQ5D-5L (health-related quality of life)","time_frame":"baseline and 3 months later"},{"outcome_type":"secondary","measure":"ICECAP-O (general quality of life)","time_frame":"baseline and 3 months later"}]}
{"nct_id":"NCT03975049","start_date":"2019-08-31","phase":"Phase 3","enrollment":933,"brief_title":"Triplet Combination or Doublet Regimen Versus Chemoradiation as Neoadjuvant Therapy for Locally Advanced Rectal Cancer","official_title":"A Prospectively Randomized Phase III Trial Comparing Short-term mFOLFOXIRI, Long-term mFOLFOX6 and Traditional Chemoradiation as Preoperative Neoadjuvant Therapy for Locally Advanced Rectal Cancer","primary_completion_date":"2024-07-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2029-07-31","last_update":"2019-06-05","description":"Preoperative radiation with single agent chemotherapy as sensitizer is the standard care of locally advanced rectal cancer. Local irradiation significantly increases surgical complications and impairs quality of life. Combination chemotherapy alone seems promising and provides similar benefit to chemoradiation as neoadjuvant therapy. Early administration of systemic therapy is also proved beneficial for long-term survival. The purpose of this study is to compare the efficacy of chemotherapy alone with short-term modified FOLFOXIRI or long-term mFOLFOX with standard chemoradiation as neoadjuvant therapy for locally advanced rectal cancer.","other_id":"SAHMO201","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  1Age: 18 to 75 years old;\r\n\r\n          -  2Histological diagnosis of rectal adenocarcinoma;\r\n\r\n          -  3Distance form anal margin  12cm: cT3-4 or cN+ and cM0 by pelvic MR and chest +\r\n             abdominal CT, estimated possible for R0 resection;\r\n\r\n          -  4There is no signs of intestinal obstruction, or obstruction of intestinal after\r\n             treating with proximal colostomy has been relieved;\r\n\r\n          -  5Patients did not previously receive rectal surgery, chemotherapy or radiation\r\n             therapy , biological treatment , except for endocrine therapy;\r\n\r\n          -  6ECOG Performance Status :0-1\r\n\r\n          -  7Life expectancy: more than 3 years;\r\n\r\n          -  8sufficient bone marrow, liver and kidney function.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  1Arrhythmia requires treatment with antiarrhythmia (except for beta-blockers or\r\n             digoxin), symptomatic coronary artery disease, myocardial ischemia (myocardial\r\n             infarction within the last 6 months) or congestive heart failure exceeding NYHA class\r\n             II;\r\n\r\n          -  2Severe hypertension with poor control;\r\n\r\n          -  3History of HIV infection or active phase of chronic hepatitis B or C infection with\r\n             high copy viral DNA;\r\n\r\n          -  4Other active serious infections according to NCI-CTC version 4.0;\r\n\r\n          -  5There is preoperative evidence for distant metastasis outside pelvis;\r\n\r\n          -  6Cachexia and organ function decompensation\r\n\r\n          -  7History of pelvic or abdominal radiotherapy;\r\n\r\n          -  8Multiple primary cancer;\r\n\r\n          -  9Patients with epilepcy requiring treatment ( steroids or antiepileptic treatment);\r\n\r\n          -  10History of other malignant tumors within 5 years, except for cured cervical\r\n             carcinoma in situ or skin basal cell carcinoma;\r\n\r\n          -  11Drug abuse and medical, psychological or social conditions interfering patient\r\n             participation in research or the evaluation of research results;\r\n\r\n          -  12Any allergy to clinical research drugs or any drugs associated with this study;\r\n\r\n          -  13Any unstable condition or condition that may endanger safety and compliance of\r\n             patients;\r\n\r\n          -  14Pregnancy or the lactating female without adequate contraception.\r\n      ","sponsor":"Sixth Affiliated Hospital, Sun Yat-sen University","sponsor_type":"Other","conditions":"Rectal Cancer|Chemotherapy Effect","interventions":[{"intervention_type":"Radiation","name":"Radiation: Chemoradiation","description":"Fluorouracil 225 mg/m2/day continuous intravenous infusion on weekdays for five weeks; local irradiation 2GY/day on weekdays, totally 50GY."},{"intervention_type":"Drug","name":"Drug: FOLFOXIRI Protocol","description":"Oxaliplatin 85 mg/m2 on day 1; irinotecan 150 mg/m2 on day 1; leucovorin 400 mg/m2 on day 1; fluorouracil 2400 mg/m2 civ over 46h; treatment will be repeated every 14 days; prophylactic G-CSF support is recommended."},{"intervention_type":"Drug","name":"Drug: Folfox Protocol","description":"Oxaliplatin 85 mg/m2 on day 1; leucovorin 400 mg/m2 on day 1; fluorouracil 400 mg/m2 bolus and 2400 mg/m2 civ over 46h; treatment will be repeated every 14 days."}],"outcomes":[{"outcome_type":"secondary","measure":"Recurrence-free survival","time_frame":"3 years","description":"The interval from randomization to local recurrence, death or the last follow-up."},{"outcome_type":"primary","measure":"Disease-free survival","time_frame":"3 years","description":"The interval from randomization to local recurrence, distant metastasis, death or the last follow-up."},{"outcome_type":"secondary","measure":"Metastasis-free survival","time_frame":"3 years","description":"The interval from randomization to distant metastasis, death or the last follow-up."},{"outcome_type":"secondary","measure":"Surgical complication","time_frame":"3 years","description":"Surgical complication including anastomotic leakage, anastomotic stricture, intestinal obstruction, postoperative pelvic bleeding and poor wound healing."},{"outcome_type":"secondary","measure":"Treatment related quality of life","time_frame":"up to 3 years","description":"EORTC QOL questionaire"},{"outcome_type":"other","measure":"Tumor regression grade after neoadjuvant therapy","time_frame":"3 months","description":"According to pathological slides"}]}
{"nct_id":"NCT04078399","start_date":"2019-08-28","phase":"N/A","enrollment":30,"brief_title":"Efficacy and Safety of Azacitidine Combined With Interferon in the Treatment of Post-transplant Recurrence","official_title":"Efficacy and Safety of Azacitidine Combined With Interferon in the Treatment of Recurrence of Allogeneic Hematopoietic Stem Cell Transplantation in Myeloid Tumors of the Blood System","primary_completion_date":"2022-08-28","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-08-28","last_update":"2020-10-27","description":"This study is a single-center, one-arm, prospective, phase II clinical trial with the primary objective of assessing the effectiveness of azacitidine combined with interferon in the prevention of recurrence after allogeneic transplantation of myeloid tumors (AML/MDS/MPN) in the blood system. Sex and safety. At the screening/baseline period, informed consent is obtained and the inclusion/exclusion criteria are checked. Plan to enroll 30 patients, and collect demographic data, medical history data, vital signs, physical examination, laboratory tests (hematuria, liver and kidney function; immune indicators: T cell subsets, Treg, etc.), pregnancy test for female patients And other necessary auxiliary inspections. The time to start treatment is: a decrease in chimerism and/or minimal residual disease (MRD) after myeloid tumor allogeneic hematopoietic stem cell transplantation.","other_id":"SHSYXY- aza-relapse-2019002","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":14,"population":"","criteria":"\n        Inclusion criteria:\r\n\r\n        Patients enrolled must meet the following criteria:\r\n\r\n          1.  14 years old, male or female;\r\n\r\n          2. Patients with allogeneic peripheral blood stem cell transplantation due to myeloid\r\n             tumors of the blood system (AML/MDS/CML/MPN, etc.);\r\n\r\n          3. Recurrence trend evaluation criteria: the proportion of bone marrow blast cells <5%;\r\n             flow cell MRD  0.01% and interval 2 consecutive times 2 times; fusion gene interval 2\r\n             weeks at least 2 consecutive positive and rising trend or from negative to positive;\r\n             Bone marrow WT1 levels increased dynamically and were greater than 0.6%; chimeric rate\r\n             (STR) decreased by >5% (STR <90%) or XY-FISH donor chimerism decreased by >0.5%;\r\n\r\n          4. Blood routine: neutrophils>0.5109/L, platelets>25.0109/L;\r\n\r\n          5. There is no active grade II or higher acute GVHD or moderate or severe chronic GVHD;\r\n\r\n          6. Liver and kidney function: liver function (AST/ALT/TB) <5 times normal upper limit;\r\n             renal function (Cr) < 2 times normal upper limit;\r\n\r\n          7. The patient must be able to understand and be willing to participate in the study and\r\n             sign an informed consent form.\r\n\r\n        Exclusion criteria:\r\n\r\n        Possible subjects who meet any of the following criteria will be excluded from the trial:\r\n\r\n          1. Recurrence after transplantation;\r\n\r\n          2. Patients who have not achieved complete remission after transplantation;\r\n\r\n          3. Implantation failed;\r\n\r\n          4. Pregnant or lactating women;\r\n\r\n          5. Have received other interventions or are receiving other research drugs before the\r\n             study begins;\r\n\r\n          6. Patient blood routine: ANC <0.5  109 / L or PLT < 25  109 / L;\r\n\r\n          7. There are active uncontrolled infections: hemodynamic instability associated with\r\n             infection, or new signs or signs of infection, or new infections in imaging,\r\n             persistent fever with asympto or signs cannot be ruled out Infected person\r\n\r\n          8. People infected with HIV;\r\n\r\n          9. Active hepatitis B (HBV), active hepatitis C (HCV) requires antiviral therapy;\r\n             patients with HBV activation risk refer to patients with hepatitis B surface antigen\r\n             positive or core antibody positive patients who do not receive anti-HBV treatment;\r\n\r\n         10. Those who are allergic to known azacitidine or interferon;\r\n\r\n         11. At the discretion of the investigator, other dangerous complications may result.\r\n      ","sponsor":"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine","sponsor_type":"Other","conditions":"HSCT|Efficacy and Safety","interventions":[{"intervention_type":"Drug","name":"Drug: Azacitidine combined with interferon preemptive treatment","description":"Azacitidine combined with interferon preemptive therapy for prevention and treatment of recurrence of allogeneic transplantation of myeloid tumors (AML/MDS/MPN) in the blood system"}],"outcomes":[{"outcome_type":"primary","measure":"Treatment response rate","time_frame":"6months","description":"Treatment response rate after 6 months of pretreatment with azacitidine combined with interferon (primary response + secondary response)"}]}
{"nct_id":"NCT04084639","start_date":"2019-08-28","phase":"N/A","enrollment":15,"brief_title":"Mycoprotein Consumption and Glucose Absorption","official_title":"To Determine the Effects of Mycoprotein Consumption on Glucose Absorption in Healthy Participants","primary_completion_date":"2019-10-16","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-10-16","last_update":"2019-11-08","description":"Previous research has demonstrated that the food found in Quorn 'Mycoprotein' can lower the blood glucose response to a meal, which may be an important finding for the management of type 2 diabetes. However, it has never been investigated how this lower response occurs, and whether there is dose-dependent response with mycoprotein. The present study will include 12 healthy young adults, who will visit the laboratory for 3 test days, with each day lasting 9 hours. On each visit, separated by a washout period of at least 2 weeks, participants will ingest either a control drink with no mycoprotein, a drink containing 20g mycoprotein or a drink containing 40g mycoprotein. By intravenously infusing labelled glucose during each visit in combination with repeated blood sampling, investigators will determine if the lower blood glucose after mycoprotein ingestion is due to reduced glucose absorption from the gut or increased uptake into body tissues.","other_id":"190206/B/06","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Basic Science","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":35,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male and female\r\n\r\n          -  18-35 years of age\r\n\r\n          -  Consumption of sufficient amounts of carbohydrate in the diet\r\n\r\n          -  Body mass index between 18.5 and 30\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes), or other form of\r\n             abnormal glucose metabolism (as this will affect outcome of the study).\r\n\r\n          -  Any diagnosed cardiovascular disease\r\n\r\n          -  Insufficient consumption of carbohydrate in the diet\r\n\r\n          -  A personal or family history of epilepsy, seizures or schizophrenia\r\n\r\n          -  Known pre-existing liver disease/condition\r\n\r\n          -  Allergy or intolerance to milk\r\n      ","sponsor":"University of Exeter","sponsor_type":"Other","conditions":"Healthy","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Mycoprotein Ingestion","description":"Ingestion of various doses of mycoprotein compared to placebo control"}],"outcomes":[{"outcome_type":"primary","measure":"Glucose absorption","time_frame":"6 hours following ingestion of drink","description":"How glucose is absorbed following the ingestion of a mycoprotein drink compared to a placebo control measured using the infusion of stable isotopes"},{"outcome_type":"secondary","measure":"Incretin Hormones","time_frame":"6 hours following ingestion of drink","description":"Measurement of glucagon-like peptide-1(GLP-1) and gastric inhibitory polypeptide (GIP) in response to mycoprotein ingestion compared to placebo control"},{"outcome_type":"secondary","measure":"Insulinaemic Response","time_frame":"6 hours following ingestion of drink","description":"Measurement of insulin response following ingestion of drinks"},{"outcome_type":"secondary","measure":"Production of Short-Chain Fatty Acids","time_frame":"6 hours following ingestion of drink","description":"Measurement of plasma acetate production in response to mycoprotein ingestion"},{"outcome_type":"secondary","measure":"Glucose Kinetics","time_frame":"6 hours following ingestion of drink","description":"Calculations using plasma deuterated glucose enrichment to determine rate of appearance of endogenous glucose, rate of disappearance of glucose and rate of appearance of exogenous glucose"}]}
{"nct_id":"NCT04134091","start_date":"2019-08-27","phase":"Phase 2","enrollment":56,"brief_title":"A Study to Assess the Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis (NASH)","official_title":"A Phase 2, Randomized Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis (NASH)","primary_completion_date":"2021-01-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2021-07-31","last_update":"2020-12-09","description":"This is a Phase 2, randomized, double-blind, placebo controlled, three arm study in adult men with biopsy confirmed NASH. The study is aimed at evaluating efficacy and tolerability of LPCN 1144 in adult men with NASH.","other_id":"LPCN 1144-18-002","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","intervention_model_description":"Randomized in 1:1:1 ratio to receive one of the following treatments:\r\nTreatment A: Oral LPCN 1144 Formulation A\r\nTreatment B: Oral LPCN 1144 Formulation B\r\nTreatment C: Oral matching placebo","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Adult male subject with histologic evidence of NASH upon central read of a liver\r\n             biopsy obtained no more than 6 months before Day 1 defined by NASH activity score\r\n             (NAS) greater than or equal to 4 with at least 1 point each in inflammation and\r\n             ballooning. Subjects who have had a biopsy more than 3 months before trial enrollment\r\n             should have stable weights between the time of the biopsy and trial initiation. Stable\r\n             weight is defined as no more than a 5% change.\r\n\r\n          2. For subjects with a historical biopsy, is either not taking or is on stable doses of\r\n             TZDs/glitazones or vitamin E (d-alpha tocopherol) for 3 months before Day 1.\r\n\r\n          3. Background therapy for other ongoing chronic conditions, and weight should be stable\r\n             for at least 3 months before trial enrollment. Stable weight is defined as no more\r\n             than a 5% change.\r\n\r\n          4. A previous historical diagnosis of hypogonadism or low testosterone at screening.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Significant alcohol consumption more than 30 g/day on average, either currently or for\r\n             a period of more than 3 consecutive months in the 5 years prior to screening.\r\n\r\n          2. Inability to reliably quantify alcohol intake.\r\n\r\n          3. Biochemical, clinical or histologic evidence of cirrhosis on liver biopsy (stage 4\r\n             fibrosis).\r\n\r\n          4. Evidence of other causes of chronic liver disease including alcoholic liver disease,\r\n             viral hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune\r\n             hepatitis, Wilson's disease, hemochromatosis, alpha-1 antitrypsin deficiency, human\r\n             immunodeficiency virus, etc.\r\n\r\n          5. Suspected or proven liver cancer\r\n\r\n          6. Clinically significant abnormal laboratory value, in the opinion of the investigator,\r\n             in serum chemistry, hematology, or urinalysis including but not limited to:\r\n\r\n               -  Hematocrit > ULN\r\n\r\n               -  Hemoglobin > ULN\r\n\r\n               -  PSA > 4 ng/mL\r\n\r\n               -  Serum AST or ALT > 200 IU/L\r\n\r\n               -  Serum ALP > 2 x ULN\r\n\r\n               -  Serum creatinine of 2.0 mg/dL or greater\r\n\r\n               -  Bilirubin > ULN\r\n\r\n               -  International normalized ratio (INR)  1.3.\r\n\r\n               -  Prolactin > ULN\r\n\r\n          7. Subjects with evidence of worsening liver function based on the two initial laboratory\r\n             values used to establish the screening / baseline values.\r\n\r\n          8. Model for End-Stage Liver Disease (MELD) score greater than 12\r\n\r\n          9. Subjects with a documented history of Gilbert's syndrome with bilirubin outside the\r\n             normal reference range.\r\n\r\n         10. Evidence of portal hypertension (e.g., low platelet counts, esophageal varices,\r\n             ascites, history of hepatic encephalopathy, splenomegaly).\r\n\r\n         11. Use of drugs historically associated with NAFLD (amiodarone, methotrexate, systemic\r\n             glucocorticoids, tetracyclines, tamoxifen, estrogens, anabolic steroids, valproic\r\n             acid, other known hepatotoxins) for more than 2 weeks in the 2 years prior to\r\n             randomization.\r\n\r\n         12. Subjects who are not on a stable dose of lipid-lowering drugs, diabetic and / or\r\n             hypertensive medication in the 3 months prior to biopsy or the 3 months prior to\r\n             randomization\r\n\r\n         13. Inability to safely obtain a liver biopsy.\r\n\r\n         14. History of total parenteral nutrition in the year prior to screening.\r\n\r\n         15. History of bariatric surgery or currently undergoing evaluation for bariatric surgery.\r\n\r\n         16. History of gastric surgery, cholecystectomy, vagotomy, bowel resection or any surgical\r\n             procedure that might interfere with gastrointestinal motility, pH or absorption.\r\n\r\n         17. History of biliary diversion.\r\n\r\n         18. Known positivity for antibody to Human Immunodeficiency Virus (HIV).\r\n\r\n         19. Known heart failure of New York Heart Association class 3 or 4.\r\n\r\n         20. Active, serious medical disease with likely life-expectancy less than 5 years.\r\n\r\n         21. History of current or suspected prostate or breast cancer.\r\n\r\n         22. History of diagnosed, severe, untreated, obstructive sleep apnea.\r\n\r\n         23. Active substance abuse in the year prior to screening.\r\n\r\n         24. History of significant sensitivity or allergy to any androgens, including\r\n             testosterone, or product excipients\r\n\r\n         25. Participation in an investigational new drug trial in the 30 days prior to\r\n             randomization without the approval of the PI and/or Sponsor.\r\n\r\n         26. History of significant sensitivity or allergy to any androgens, including\r\n             testosterone, or product excipients.\r\n\r\n         27. History of seizures or convulsions, including alcohol or drug withdrawal seizures.\r\n\r\n         28. Use of known inhibitors (e.g., ketoconazole) or inducers (e.g., dexamethasone,\r\n             phenytoin, rifampin, carbamazepine) of cytochrome P450 3A (CYP3A) within 30 days prior\r\n             to study drug administration and through the end of the study.\r\n\r\n         29. Subjects who are currently receiving any androgens (testosterone or other androgens or\r\n             androgen supplements). Subjects who are on testosterone may be eligible for the study\r\n             following an adequate washout (12 weeks following intramuscular androgen injections; 4\r\n             weeks following topical or buccal androgens; 3 weeks following oral androgens).\r\n\r\n         30. Vitamin E supplementation of greater than 100 IU/day, unless completed adequate\r\n             washout for at least 4 weeks prior to Day 1 or biopsy if one is required.\r\n\r\n         31. Use of any drug within 5 half-lives of the last dose in the past 6 months prior to\r\n             Study Day -2 without PI and/or Sponsor approval.\r\n\r\n         32. Any contraindications to a MRI scan (i.e. subjects with non-removable ferromagnetic\r\n             implants, pacemakers, aneurysm clips or other foreign bodies), and/or subjects with\r\n             claustrophobic symptoms and/or inability to fit into an MRI scanner.\r\n\r\n         33. Receipt of any drug by injection within 30 days or 10 half-lives (whichever is longer)\r\n             prior to study drug administration without PI and/or Sponsor approval. Insulin,\r\n             allergy shots, and vaccines are allowed.\r\n\r\n         34. Subject who is not willing to use adequate contraception for the duration of the\r\n             study.\r\n\r\n         35. Any other condition, which in the opinion of the investigator would impede compliance\r\n             or hinder completion of the study.\r\n\r\n         36. Failure to give informed consent.\r\n      ","sponsor":"Lipocine Inc.","sponsor_type":"Industry","conditions":"Nonalcoholic Steatohepatitis (NASH)","interventions":[{"intervention_type":"Drug","name":"Drug: LPCN 1144 Formulation A","description":"Oral LPCN 1144 Formulation A capsule, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose)"},{"intervention_type":"Drug","name":"Drug: LPCN 1144 Formulation B","description":"Oral LPCN 1144 Formulation B capsule, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose)"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Oral matching placebo capsule administered as BID"}],"outcomes":[{"outcome_type":"secondary","measure":"Change in hepatic fat fraction based on MRI-PDFF measurements in LPCN 1144 treated subjects compared to placebo.","time_frame":"Baseline to Week 36"},{"outcome_type":"secondary","measure":"Change in NASH activity evaluated via a standardized scoring of liver biopsies at baseline and after 36 weeks of treatment in LPCN 1144 treated subjects compared to placebo.","time_frame":"Baseline to Week 36"},{"outcome_type":"primary","measure":"Change in hepatic fat fraction based on MRI-PDFF measurements in LPCN 1144 treated subjects compared to placebo.","time_frame":"Baseline to Week 12"},{"outcome_type":"secondary","measure":"Relative change in hepatic fat fraction based on MRI-PDFF measurements in LPCN 1144 treated subjects compared to placebo.","time_frame":"Baseline to week 12"},{"outcome_type":"secondary","measure":"Relative change in hepatic fat fraction based on MRI-PDFF measurements in LPCN 1144 treated subjects compared to placebo.","time_frame":"Baseline to Week 36"},{"outcome_type":"secondary","measure":"NAFLD resolution of subjects who at baseline are at least 5% with a decrease to less than 5% at end of study in LPCN 1144 treated subjects compared to placebo.","time_frame":"Baseline to Week 36"},{"outcome_type":"secondary","measure":"Resolution of NASH on overall histopathological reading in LPCN 1144 treated subjects compared to placebo. Resolution of NASH is defined as NAS score of 0-1 for inflammation, 0 for ballooning, and any value for steatosis.","time_frame":"Baseline to Week 36"},{"outcome_type":"secondary","measure":"Resolution of NASH on overall histopathological reading and no worsening of liver fibrosis on NASH CRN fibrosis score in LPCN 1144 treated subjects compared to placebo..","time_frame":"Baseline to Week 36"},{"outcome_type":"secondary","measure":"Change in fibrosis score via NASH Clinical Research Network fibrosis score (0-4) of liver biopsies in LPCN 1144 treated subjects compared to placebo.","time_frame":"Baseline to Week 36","description":"Lower score indicates improvement in fibrosis"},{"outcome_type":"secondary","measure":"Improvement in liver fibrosis greater than or equal to one stage (NASH Clinical Research Network fibrosis score, 0-4) in LPCN 1144 treated subjects compared to placebo..","time_frame":"Baseline to Week 36","description":"Lower score indicates improvement in fibrosis"},{"outcome_type":"secondary","measure":"Improvement in liver fibrosis greater than or equal to one stage (NASH Clinical Research Network fibrosis score, 0-4) and no worsening of NASH (defined as no increase in NAFLD Activity Score (0-8)) in LPCN 1144 treated subjects compared to placebo.","time_frame":"Baseline to Week 36","description":"Lower score indicates improvement on both scales"},{"outcome_type":"secondary","measure":"Change in insulin resistance (assessed by Homeostasis Model Assessment (HOMA)) in LPCN 1144 treated subjects compared to placebo.","time_frame":"Baseline to Week 36"},{"outcome_type":"secondary","measure":"Changes in liver enzymes aspartate transaminase (AST), (alanine transaminase (ALT), alkaline phosphatase (ALP), gamma-glutamyltransferase (GGT), Total Bilirubin (TB) and Creatine Kinase (CK) in LPCN 1144 treated subjects compared to placebo.","time_frame":"Baseline to Week 36"},{"outcome_type":"secondary","measure":"Changes in non-invasive markers of fibrosis and steatosis in LPCN 1144 treated subjects compared to placebo.","time_frame":"Baseline to Week 36"},{"outcome_type":"secondary","measure":"Changes in serum lipid profile parameters (LDL, HDL, and triglycerides) in LPCN 1144 treated subjects compared to placebo.","time_frame":"Baseline to Week 36"},{"outcome_type":"secondary","measure":"Changes in Functional Activity (NHANES Physical Activity and Physical Fitness - PAQ, 2017) in LPCN 1144 treated subjects compared to placebo.","time_frame":"Baseline to Week 36"},{"outcome_type":"secondary","measure":"Changes in weight (kg) in LPCN 1144 treated subjects compared to placebo.","time_frame":"Baseline to Week 36"},{"outcome_type":"secondary","measure":"Changes in body mass index (BMI) in LPCN 1144 treated subjects compared to placebo.","time_frame":"Baseline to Week 36"},{"outcome_type":"secondary","measure":"Changes in waist circumference (cm) in LPCN 1144 treated subjects compared to placebo.","time_frame":"Baseline to Week 36"},{"outcome_type":"secondary","measure":"Changes in waist to hip ratio (each measured in cm) in LPCN 1144 treated subjects compared to placebo.","time_frame":"Baseline to Week 36"},{"outcome_type":"secondary","measure":"Changes in measurements of triceps skin fold thickness (mm) and upper arm circumference (mm) in LPCN 1144 treated subjects compared to placebo.","time_frame":"Baseline to Week 36"}]}
{"nct_id":"NCT04070807","start_date":"2019-08-23","enrollment":70,"brief_title":"Italian Observational Study of Patients With Acute Myeloid Leukemia Treated With Small Molecule Inhibiting BCL-2","official_title":"Italian Observational Study of Patients With Acute Myeloid Leukemia Treated With Small Molecule Inhibiting B-cell Lymphoma 2 (BCL-2)","primary_completion_date":"2020-12-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2020-12-31","last_update":"2020-04-21","description":"This is a multi-center retrospective observational study. Every patient with Acute Myeloid Leukemia (AML) treated with anti-B-cell lymphoma 2 (BCL2) treatment outside clinical trial from 1st January 2015 up to 01 April 2019 may be included in this study. No additional drug/procedures/patient visits in comparison with the usual clinical practice are planned for the study. The decision to treat patient with ant-BCL2 inhibitors is made by the physician based on his clinical judgment, independently from the decision to include the patient in this study.","other_id":"IRST204.04","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"AML according to World Health Organization (WHO) 2016 classification who have received any\r\n        anti-BCL-2 treatment as single agent or in combination with other drugs from 1 Jan 2015 to\r\n        1 Apr 2019 outside clinical trials","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patient with AML according to World Health Organization (WHO) 2016 classification\r\n\r\n          -  Patient who have received any anti-BCL-2 treatment as single agent or in combination\r\n             with other drugs from 1 Jan 2015 to 1 Apr 2019 outside clinical trials\r\n\r\n        Exclusion Criteria:\r\n\r\n         Patient who have received any anti-BCL-2 treatment within a clinical trials\r\n      ","sponsor":"Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori","sponsor_type":"Other","conditions":"Acute Myeloid Leukemia","interventions":{},"outcomes":[{"outcome_type":"secondary","measure":"Collection of days of hospitalizations","time_frame":"18 months","description":"to describe healthcare resource utilization in terms of days of hospitalizations per patient"},{"outcome_type":"primary","measure":"Incidence of Adverse Events of grade 3 and 4 (NCTCAE version 5.0)","time_frame":"up to 18 months","description":"To evaluate the toxicity profile of the therapy with anti-BCL-2 in patients with AML."},{"outcome_type":"secondary","measure":"Overall Survival","time_frame":"18 months","description":"to describe the clinical outcomes in terms of Overall Survival (OS) defined as the number of days between the first study drug administration and death from any cause"},{"outcome_type":"secondary","measure":"Disease Free Survival (DFS)","time_frame":"18 months","description":"to describe Disease Free Survival, defined as the number of days between the first study drug administration and any event including disease progression or death from any cause (both median and restricted mean) whichever occurs first."},{"outcome_type":"secondary","measure":"Complete Remission","time_frame":"18 months","description":"to describe the Complete Remission (CR), in terms of proportions, in response to therapy"},{"outcome_type":"secondary","measure":"Complete Remission with incomplete hematologic recovery","time_frame":"18 months","description":"to describe Complete Remission with incomplete hematologic recovery (CRi) in terms of proportions, in response to therapy"},{"outcome_type":"secondary","measure":"Minimal Residual Disease","time_frame":"18 months","description":"to describe Minimal Residual Disease, in terms of proportions, in response to therapy"},{"outcome_type":"secondary","measure":"Incidence of successful bridge to allogeneic transplant","time_frame":"18 months","description":"to describe the incidence of successful bridge to allogeneic transplant, in terms of proportions, in response to therapy"},{"outcome_type":"secondary","measure":"Collection of number of hospitalizations","time_frame":"18 months","description":"to describe healthcare resource utilization in terms of number of hospitalizations per patient"},{"outcome_type":"secondary","measure":"Collection of number of clinical visits per patient","time_frame":"18 months","description":"to describe healthcare resource utilization in terms of number of clinical visits per patient"},{"outcome_type":"secondary","measure":"Collection of number of accesses Day Hospital per patient","time_frame":"18 months","description":"to describe healthcare resource utilization in terms of number of accesses in Day Hospital per patient"},{"outcome_type":"secondary","measure":"Collection of number of accesses in Emergency Care Units per patient","time_frame":"18 months","description":"to describe healthcare resource utilization in terms of number of accesses in Emergency Care Units per patient"}]}
{"nct_id":"NCT04404751","start_date":"2019-08-23","phase":"N/A","enrollment":174,"brief_title":"Quadruple Fortified Salt Clinical Trial","official_title":"Effectiveness of Quadruple Fortified Salt in Improving Hemoglobin Levels Among Anemic Women of Reproductive Age (18-49 Years) in Rural Low Resource Setting","primary_completion_date":"2020-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-12-31","last_update":"2021-02-23","description":"Anaemia is the world leading cause of disability and is responsible for about more than 115,000 maternal deaths and 591,000 perinatal deaths per year, of which 3/4 occur in Africa and Asia. Despite the fact that there are several causes of anemia, the most important causes are due to micronutrients deficiency, namely iron, Folic acid and Vitamin B12. Low intakes of these micronutrients consequently affect a woman's health, pregnancy outcome and the nutritional status of breast-fed children. With these in mind we wish to test the effectiveness of salt fortified with these four micronutrients (Iodine, Iron, Folic acid and vitamin B12) in raising the Hemoglobin levels among the non-pregnant and non-lactating women of reproductive age.","other_id":"Salt_HGHRC#01","allocation":"Randomized","intervention_model":"Factorial Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":49,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adult with relative low haemoglobin (Hb level 8g/dl to 13g/dl)\r\n\r\n          -  Able to eat food cooked with salt\r\n\r\n          -  Able to give consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Planning to become pregnant within the study period,\r\n\r\n          -  chronically ill,\r\n\r\n          -  have haematological diseases during study time,\r\n\r\n          -  restricted to use salt in food\r\n      ","sponsor":"Haydom Lutheran Hospital","sponsor_type":"Other","conditions":"Anemia","interventions":[{"intervention_type":"Combination Product","name":"Combination Product: Iodised salt with Iron, Folic acid and Vitamin B12","description":"Fortified salt with either Iron and Iodine only or Fortified salt with Iodine, iron, Folic acid and Vitamin B12 compared with standard Iodized salt"}],"outcomes":[{"outcome_type":"primary","measure":"Haemoglobin level","time_frame":"10 months of consuming fortified salt","description":"After 10months use of quadruple fortified salt we expect the HB to rise by at least 50% as compared to those who used iodised salt"},{"outcome_type":"secondary","measure":"Iron store replenishment","time_frame":"10months of intervention","description":"The quadruple fortified salt is expected to replenish the iron store 100% after 10 months use of QFS"}]}
{"nct_id":"NCT04081688","start_date":"2019-08-21","phase":"Phase 1","enrollment":15,"brief_title":"Atezolizumab and Varlilumab in Combination With Radiation Therapy for NSCLC","official_title":"A Phase I Trial of Atezolizumab and Varlilumab in Combination With Radiation in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC)","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-06-30","last_update":"2021-04-08","description":"This phase I trial studies the side effects of atezolizumab, varlilumab, and radiation therapy in treating patients with non-small cell lung cancer that has spread to other places in the body (advanced) and cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies such as atezolizumab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies such as varlilumab may induce changes in body?s immune system and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving atezolizumab, varlilumab, and radiation therapy may increase the amount of time the disease is not active or does not spread to another part of the body.","other_id":"Pro2019000923","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Must have signed and dated written informed consent form in accordance with regulatory\r\n             and institutional guidelines\r\n\r\n          -  Histological or cytological evidence of advanced, unresectable NSCLC\r\n\r\n          -  Patients must be PD-1/PD-L1 experienced with disease progression documented either on\r\n             therapy with anti-PD-1/PD-L1 or within 12 weeks of the last dose. Treatment should be\r\n             initiated at least 4 weeks since last dose of PD-1/PD-L1 targeted therapy\r\n\r\n          -  Patients must have progressed on at least one line of prior platinum-based\r\n             chemotherapy in the metastatic setting. Subjects with unresectable stage III NSCLC who\r\n             received platinum-based chemotherapy as part of chemoradiation or consolidation\r\n             chemotherapy after chemoradiation are eligible if they progress within 6 months of\r\n             last dose of chemotherapy. Treatment should be initiated at least 4 weeks since last\r\n             dose of systemic therapy\r\n\r\n          -  Subjects with an actionable molecular alteration (such as EGFR mutation, ALK or ROS1\r\n             rearrangement, BRAF V600E mutation) are eligible only after failing standard-of-care\r\n             targeted therapy with tyrosine kinase inhibitor (TKI). Patients with a EGFR T790M\r\n             resistant mutation must have failed a 3rd generation TKI such as osimertinib\r\n\r\n          -  Must not have received any prior therapy with immune regulatory molecule (such as\r\n             targeting OX-40, IDO-1, LAG-3) or anti-CD27 monoclonal antibody (including varlilumab)\r\n\r\n          -  Must have at least one lesion that has not previously been irradiated (and is not\r\n             within a previously radiated field) and for which palliative radiation is potentially\r\n             indicated. The lesion to be irradiated must be in the lung. Patient must have at least\r\n             one additional measurable lesion (other than the lesion being radiated) as per\r\n             immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) criteria.\r\n             Patient must agree to undergo a mandatory biopsy of the non-irradiated lesion\r\n             pre-treatment and post-treatment (after cycle 2). Pre-treatment tissue obtained by\r\n             biopsy or resection performed according to standard of care may be utilized, provided\r\n             tissue was obtained within 8 weeks of study entry, and subsequent to the last systemic\r\n             anticancer therapy received\r\n\r\n          -  Patients should have fewer than 10 metastatic sites and expected survival of more than\r\n             3 months\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\r\n\r\n          -  Treatment to be initiated at least 2 weeks since last dose of prior systemic\r\n             anticancer therapy (chemotherapy, radiation, and/or surgery)\r\n\r\n          -  Recovery to grade 1 of any clinically significant toxicity (excluding alopecia, grade\r\n             2 fatigue, vitiligo, endocrinopathies on stable replacement therapy, grade 2\r\n             neuropathy from chemotherapy and grade 2 hearing loss from platinum chemotherapy)\r\n             prior to initiation of study drugs\r\n\r\n          -  Female patients of childbearing potential have a negative pregnancy test at baseline.\r\n             Females of childbearing potential are defined as sexually mature women without prior\r\n             hysterectomy or who have had any evidence of menses in the past 12 months. However,\r\n             women who have been amenorrheic for 12 or more months are still considered to be of\r\n             childbearing potential if the amenorrhea is possibly due to prior chemotherapy,\r\n             anti-estrogens, or ovarian suppression\r\n\r\n               -  Women of childbearing potential (i.e., menstruating women) must have a negative\r\n                  urine pregnancy test (positive urine tests are to be confirmed by serum test)\r\n                  documented within 14 days of treatment initiation\r\n\r\n               -  Sexually active women of childbearing potential enrolled in the study must agree\r\n                  to use 2 forms of accepted methods of contraception during the course of the\r\n                  study and for 12 weeks after their last dose of study drug. Effective birth\r\n                  control includes (a) intrauterine device plus 1 barrier method; (b) on stable\r\n                  doses of hormonal contraception for at least 3 months (e.g., oral, injectable,\r\n                  implant, transdermal) plus one barrier method; (c) 2 barrier methods. Effective\r\n                  barrier methods are male or female condoms, diaphragms, and spermicides (creams\r\n                  or gels that contain a chemical to kill sperm); or (d) a vasectomized partner\r\n\r\n               -  For male patients who are sexually active and who are partners of premenopausal\r\n                  women: agreement to use 2 forms of contraception as in criterion above during the\r\n                  treatment period and for 12 weeks after the last dose of study drug\r\n\r\n          -  Absolute neutrophil count >= 1,500/uL\r\n\r\n          -  Platelet count >= 100,000/uL\r\n\r\n          -  Hemoglobin >= 9.0 g/dL\r\n\r\n          -  Total bilirubin =< 2 x upper limit of normal (ULN) or =< 3 x ULN for subjects with\r\n             Gilbert?s disease or liver metastases\r\n\r\n          -  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN (=< 5 x\r\n             ULN if evidence of hepatic involvement by malignant disease)\r\n\r\n          -  Creatinine =< 1.5 x ULN or estimated glomerular filtration rate (eGFR) >= 40\r\n             mL/min/1.73m^2\r\n\r\n          -  Measurable disease according to irRECIST obtained by imaging within 28 days prior to\r\n             treatment initiation\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnant or breastfeeding, or expecting to conceive or father children within the\r\n             projected duration of the trial, starting with the pre-screening or screening visit\r\n             through 23 weeks (female) or 31 weeks (male) after the last dose of study drug\r\n\r\n          -  Treatment with any investigational agent within 28 days prior to registration for\r\n             protocol therapy\r\n\r\n          -  History of psychiatric illness or social situations that would limit compliance with\r\n             study requirements. Has a history or current evidence of any condition, therapy, or\r\n             laboratory abnormality that might confound the results of the trial, interfere with\r\n             the subject?s participation for the full duration of the trial, or is not in the best\r\n             interest of the subject to participate, in the opinion of the treating investigator\r\n\r\n          -  Known active, untreated central nervous system (CNS) metastases and/or carcinomatous\r\n             meningitis except for patients with =< 3 small (< 0.6 cm) asymptomatic brain lesions\r\n             where treatment is not indicated. Patients with neurological symptoms must undergo a\r\n             head computed tomography (CT) scan or brain magnetic resonance imaging (MRI) to\r\n             exclude brain metastasis. Patients whose brain metastases have been treated may\r\n             participate provided they show radiographic stability (defined as 2 brain images\r\n             obtained after treatment to the brain metastases at least 4 weeks apart and show no\r\n             evidence of intracranial progression)\r\n\r\n          -  Known history of human immunodeficiency virus (HIV) or active hepatitis B (by surface\r\n             antigen expression or polymerase chain reaction [PCR]) or active hepatitis C (by PCR)\r\n             infection\r\n\r\n          -  Diagnosis of immunodeficiency or is receiving systemic steroid therapy (> 10 mg daily\r\n             prednisone equivalent) or any other form of immunosuppressive therapy within 7 days\r\n             prior to study registration\r\n\r\n          -  Has active autoimmune disease that has required systemic treatment in the past 2 years\r\n             (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive\r\n             drugs) or a documented history of clinically severe autoimmune disease, or a syndrome\r\n             that requires systemic steroids or immunosuppressive agents. Vitiligo, alopecia,\r\n             hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic\r\n             treatment, celiac disease controlled by diet alone or conditions not expected to recur\r\n             in the absence of an external trigger are permitted\r\n\r\n          -  Documented history of a cerebral vascular event (stroke or transient ischemic attack),\r\n             unstable angina, myocardial infarction, or cardiac symptoms consistent with New York\r\n             Heart Association (NYHA) class III?IV within 6 months prior to their first dose of\r\n             study drugs\r\n\r\n          -  Prior malignancies (except non-melanoma skin cancers, and the following in situ\r\n             cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or\r\n             breast) unless a complete remission was achieved at least 1 year prior to study entry\r\n\r\n          -  Any active grade 3 or higher viral, bacterial, or fungal infection within 2 weeks of\r\n             the first dose of the study drugs. Routine antimicrobial prophylaxis is permitted\r\n\r\n          -  Active diverticulitis\r\n\r\n          -  History of idiopathic pulmonary fibrosis, pneumonitis (including drug-induced),\r\n             organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing\r\n             pneumonia, etc.), or evidence of active pneumonitis on screening chest CT scan.\r\n             History of radiation pneumonitis in the radiation field (fibrosis) is permitted\r\n      ","sponsor":"Rutgers, The State University of New Jersey","sponsor_type":"Other","conditions":"Refractory Lung Non-Small Cell Carcinoma|Stage IV Lung Cancer AJCC v8","interventions":[{"intervention_type":"Drug","name":"Drug: Atezolizumab 1200 MG in 20 ML Injection","description":"Given IV every 3 weeks (cycle is 21 days)"},{"intervention_type":"Radiation","name":"Radiation: Stereotactic Body Radiation Therapy","description":"Undergo SBRT between cycle 1 and cycle 2 (each cycle is 21 days)"},{"intervention_type":"Drug","name":"Drug: Varlilumab 3 mg/kg","description":"Given IV every 3 weeks (cycle is 21 days)"}],"outcomes":[{"outcome_type":"primary","measure":"Assess the safety and tolerability of combined therapy in patients with metastatic NSCLC who have progressed on prior PD-1/PD-L1 therapy","time_frame":"Up to 30 days after the last dose of treatment","description":"Will include grade 3 and 4 toxicities as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0."},{"outcome_type":"secondary","measure":"To determine objective response rate (ORR) of therapy","time_frame":"From the start of treatment until disease progression/recurrence, assessed up to 1 year","description":"Will be defined as the proportion of all subjected confirmed with an immune-related partial response (irPR) or immune-related complete response (irCR) divided by the number of assigned patients according to immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)."},{"outcome_type":"secondary","measure":"To estimate clinical benefit rate of the combination","time_frame":"Up to 1 year","description":"Will be defined as the percentage of patients who achieve irCR, irPR, and immune-related stable disease."},{"outcome_type":"secondary","measure":"To estimate median progression-free survival (PFS) of the combination","time_frame":"From cycle 1, day 1 (each cycle is 21 days) of treatment until the criteria for disease progression is met as defined by irRECIST or death as a result of any cause, assessed up to 1 year","description":"The log-rank test will be used to analyze PFS for comparison of treatment effects, i.e., the only covariate that will be used is the treatment arm. Distributions of PFS times will be estimated using the Kaplan- Meier product-limit method. The median PFS times with two-sided 95% confidence intervals will be estimated for each treatment group."},{"outcome_type":"secondary","measure":"To compare the frequency of immune-related adverse events (irAEs)","time_frame":"Up to 30 days after the last dose of treatment","description":"irAE's are defined as any treatment-related AE that is inflammatory in nature, consistent with the mechanism of action of immunotherapy and generally medically manageable with topical and/or systemic immunosuppressants."},{"outcome_type":"other","measure":"To compare pre- and post-treatment tumor PD-L1 expression","time_frame":"Baseline up to cycle 2, day 8 (each cycle is 21 days)","description":"Will be assessed by immunohistochemistry (IHC) and will score the percentage of cells staining positively for PD-L1 incrementally. Scoring will be performed for the percentage of malignant tumor cells and for the percentage of nonmalignant inflammatory cell compartment that express PD-L1, separately."},{"outcome_type":"other","measure":"To compare pre- and post-treatment tumor levels of infiltrating CD3+, CD8+ T-cells","time_frame":"Baseline up to cycle 2, day 8 (each cycle is 21 days)","description":"Will be assessed by IHC staining to identify tumor infiltrating lymphocytes at the tumor stroma interface."}]}
{"nct_id":"NCT04150926","start_date":"2019-08-15","phase":"N/A","enrollment":26,"brief_title":"The Effect of Black Currant on Postprandial Glucose Metabolism","official_title":"The Effect of Black Currant on Postprandial Glucose Metabolism","primary_completion_date":"2020-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-04-30","last_update":"2020-09-04","description":"The study examines the effect of black currant on glucose and insulin concentrations after a meal. In addition, the cytokine and free fatty acids levels are of interest.","other_id":"894/2019","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Prevention","masking_description":"Single","intervention_model_description":"Meal studies in randomised order","sampling_method":"","gender":"All","minimum_age":25,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  age: 25-65 years\r\n\r\n          -  BMI: 20-28 kg/m2\r\n\r\n          -  Perceived health status: Good\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  fasting glucose: > 7.0 mmol/l\r\n\r\n          -  LDL-cholesterol: > 3.0 mmol/l\r\n\r\n          -  total cholesterol: > 6.5 mmol/l\r\n\r\n          -  blood pressure : > 160/100 mmHg\r\n\r\n          -  weight change of > 5% during previous 6 months or active weightreduction\r\n\r\n          -  no serious chronic diseases\r\n\r\n          -  one exception of the exclusion criteria maybe accepted after the MD consideration\r\n      ","sponsor":"University of Eastern Finland","sponsor_type":"Other","conditions":"Postprandial Hyperglycemia|Prediabetic State","interventions":[{"intervention_type":"Other","name":"Other: Black currant","description":"The effect of black currant puree will be compared with black currant-quinoa product, quinoa base and with liquid with glucose, fructose and sucrose\r\nExperimental: Black currant and quinoa product\r\nActive Comparator: Quinoa base Meal study comparing the effect of black currant puree with liquid with glucose, fructose and sucrose, black currant and quinoa product and quinoa base"},{"intervention_type":"Other","name":"Other: Black currant-quinoa product","description":"The effect of black currant puree will be compared with black currant-quinoa product"},{"intervention_type":"Other","name":"Other: Quinoa base","description":"The effect of black currant puree will be compared with quinoa base"}],"outcomes":[{"outcome_type":"primary","measure":"Glucose concentration","time_frame":"0 minutes until 180 minutes","description":"Glucose concentration after meal"},{"outcome_type":"primary","measure":"Insulin concentration","time_frame":"0 minutes until 180 minutes","description":"Insulin concentration after meal"}]}
{"nct_id":"NCT04116385","start_date":"2019-08-15","enrollment":75,"brief_title":"Evaluation of the Quantra System in a Surgical Oncological Population","official_title":"Evaluation of the Quantra System in a Surgical Oncological Population","primary_completion_date":"2020-03-12","study_type":"Observational","rec_status":"Completed","completion_date":"2020-07-30","last_update":"2020-09-01","description":"This study will monitor coagulation parameters during the perioperative course of cancer surgical procedures using the Quantra System with the QPlus Cartridge.","other_id":"HEMCS-025","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"The study population includes adult subjects undergoing an oncologic surgical procedure.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subject is >= 18 years\r\n\r\n          -  Subject is diagnosed with cancer and is scheduled for surgical resection\r\n\r\n          -  Subject is willing to participate, and he/she or a Legally Authorized Representative\r\n             (LAR) has signed a consent form\r\n\r\n          -  Surgical procedure to be performed has an anticipated blood loss (>500mL) based on\r\n             historical data\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subject is younger than 18 years\r\n\r\n          -  Subject or a subject's LAR is unable to provide written informed consent\r\n\r\n          -  Subject is undergoing an emergent procedure.\r\n\r\n          -  Subject is pregnant, has active liver disease, or severe renal dysfunction (creatinine\r\n             clearance (CrCL)<30 mL/min)\r\n\r\n          -  Subject has an extremely low platelet count (<40,000/uL)\r\n\r\n          -  Subject is currently enrolled in a distinct study that might confound the results of\r\n             the proposed study\r\n\r\n          -  Subject is affected by a condition that, in the opinion of the clinical team, may pose\r\n             additional risks\r\n      ","sponsor":"HemoSonics LLC","sponsor_type":"Industry","conditions":"Blood Loss, Surgical","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Quantra System","description":"Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care."}],"outcomes":[{"outcome_type":"primary","measure":"Comparison of Quantra Clot Time results to TEG R results","time_frame":"Baseline, defined as after induction of anesthesia, before surgical incision","description":"Coagulation function assessed by Quantra and TEG 5000"},{"outcome_type":"primary","measure":"Comparison of Quantra Clot Stiffness results to TEG MA results","time_frame":"Baseline, defined as after induction of anesthesia, before surgical incision","description":"Coagulation function assessed by Quantra and TEG 5000"},{"outcome_type":"primary","measure":"Comparison of Quantra Time results to TEG R results","time_frame":"During surgery","description":"Coagulation function assessed by Quantra and TEG 5000"},{"outcome_type":"primary","measure":"Comparison of Quantra Clot Stiffness results to TEG MA results","time_frame":"During surgery","description":"Coagulation function assessed by Quantra and TEG 5000"},{"outcome_type":"primary","measure":"Comparison of Quantra Clot Time results to TEG R results","time_frame":"Post-surgery, while patient is in the ICU/PACU, usually within 24 hours of surgery","description":"Coagulation function assessed by Quantra and TEG 5000"},{"outcome_type":"primary","measure":"Comparison of Quantra Clot Stiffness results to TEG MA results","time_frame":"Post-surgery, while patient is in the ICU/PACU, usually within 24 hours of surgery","description":"Coagulation function assessed by Quantra and TEG 5000"}]}
{"nct_id":"NCT04101526","start_date":"2019-08-15","phase":"N/A","enrollment":60,"brief_title":"Developing and Testing a Spanish-Language Intervention to Reduce Cancer-Related Sleep Disturbance","official_title":"Developing and Testing a Spanish-Language Intervention to Reduce Cancer-Related Sleep Disturbance","primary_completion_date":"2021-12-24","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2022-12-24","last_update":"2021-08-04","description":"The purpose of this study is to learn about how to provide treatment to cancer survivors who have difficulty sleeping.","other_id":"MCC-20086","allocation":"Non-Randomized","intervention_model":"Sequential Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Located in the Southern Puerto Rico area\r\n\r\n          -  Able to speak and read Spanish\r\n\r\n          -  Have no documented or observable disabilities that would interfere with study\r\n             participation\r\n\r\n          -  Has completed primary treatment for breast cancer (e.g., surgery, chemotherapy,\r\n             radiation)\r\n\r\n          -  Has clinically significant sleep disturbance (i.e., >/= 8 on the Insomnia Severity\r\n             Index)\r\n\r\n          -  Is at low risk of other sleep disorders that are not amenable to treatment with\r\n             cognitive-behavioral therapy\r\n\r\n          -  Has access to the Internet and a digital device (e.g., smartphone) capable of using\r\n             videoconference software\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Not able to read and speak Spanish\r\n      ","sponsor":"H. Lee Moffitt Cancer Center and Research Institute","sponsor_type":"Other","conditions":"Sleep Disturbance","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference","description":"Six sessions of Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference. Sessions address topics such as sleep education, sleep hygiene, sleep compression, sleep restriction, stimulus control, relapse prevention, and cognitive restructuring."}],"outcomes":[{"outcome_type":"primary","measure":"Acceptability of New Intervention for Cancer-Related Sleep Disturbances","time_frame":"approximately 6 weeks after first intervention session","description":"The study will be deemed acceptable if ≥ 50% of eligible cancer survivors who are approached agree to participate and > 50% of intervention group participants report that, on average, they agree with positive statements about the intervention (i.e., report an average score of ≥3 on a scale of 0 to 4)."},{"outcome_type":"primary","measure":"Feasibility of New Intervention for Cancer-Related Sleep Disturbances","time_frame":"approximately 6 weeks after first intervention session","description":"The study will be deemed feasible if ≥ 75% of the intervention group participants attend at least half of the educational components of the intervention. This will be operationalized as having attended at least half of the sessions."},{"outcome_type":"secondary","measure":"Efficacy of New Intervention","time_frame":"approximately 6 weeks after first intervention session","description":"Efficacy of the newly created intervention will be assessed using (a) Scores on the Pittsburgh Sleep Quality Index, which consists of 19 individual items creating 7 components that produce one global score. Each item is weighted on a 0-3 interval scale. The global score is calculated by totaling the 7 component scores, producing a score ranging from 0-21, where lower scores denote a healthier sleep quality. (b) the Insomnia Severity Index, which has 7 questions on a 0-4 scale. Items are totaled to produce a score ranging from 0-28, where higher scores denote worse insomnia severity."}]}
{"nct_id":"NCT04046562","start_date":"2019-08-14","phase":"N/A","enrollment":50,"brief_title":"Pain and Weight Treatment: Development and Trial of PAW","official_title":"Pain and Weight Treatment: Development and Trial of PAW","primary_completion_date":"2022-03-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-03-31","last_update":"2021-08-02","description":"Pediatric weight management efficacy is impacted by failure to complete treatment protocols and, for those that do complete treatment, a return to unhealthy behaviors. This project tests whether treating pain, a common comorbid condition to pediatric obesity, will enhance treatment. This study will generate results that can be translated into immediate improvements in care for families seeking treatment for pediatric obesity.","other_id":"14-079","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Patients will be randomized to one of two arms. One arm is PAW plus standard of care and the second arm is pain education plus standard of care.","sampling_method":"","gender":"All","minimum_age":12,"maximum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Males and females between 12 and 18 years of age\r\n\r\n          -  Ability to speak, write and read English\r\n\r\n          -  A parent or guardian who speaks, writes and reads English\r\n\r\n          -  Signed consent and assent from the child and parent\r\n\r\n          -  Enrollment in a weight management program\r\n\r\n          -  Score greater than 3 on the Pain Burden Inventory at screening (in order to recruit\r\n             adolescents who experience more than just general aches and pains).\r\n\r\n          -  Youth reporting musculoskeletal pain\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Parent or guardian unable to participate\r\n\r\n          -  Patients on weight reducing medications\r\n\r\n          -  Severe psychiatric illness (i.e., suicidal or hospitalization within past 6 months)\r\n\r\n          -  Medical conditions such as Type 1 diabetes\r\n      ","sponsor":"Connecticut Children's Medical Center","sponsor_type":"Other","conditions":"Obesity, Adolescent|Pain, Chronic|CBT","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: PAW","description":"Pain and Weight Treatment plus standard of care"},{"intervention_type":"Behavioral","name":"Behavioral: Pain Education","description":"Pain Education plus standard of care"}],"outcomes":[{"outcome_type":"primary","measure":"Mean difference in session attendance between groups","time_frame":"Through the 13 weeks that comprise fit5","description":"The number of sessions of fit5 attended will be compared between the group attending PAW and those in the information control group."},{"outcome_type":"secondary","measure":"The feasibility and acceptability of the PAW intervention will be examined Via exit interviews","time_frame":"At the conclusion of the 13 weeks of the program","description":"At the exit interviews, we will inquire with families whether 4 sessions felt sufficient, whether they would have liked more or less sessions and when they would have liked sessions scheduled."},{"outcome_type":"secondary","measure":"The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires.","time_frame":"At the conclusion of the 13 weeks of the program","description":"Although not powered to be able to detect clinically significant differences pre and post program completion, as part of standard of care families complete a battery of measures prior to and after their completion in the fit5 program. Family scores on these responses will be examined to see if trends show changes in a meaningful and clinically relevant direction.\r\nDepressed mood: The Center for Epidemiological Studies Depression Scale for Children (CES-DC)"},{"outcome_type":"secondary","measure":"The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires.","time_frame":"At the conclusion of the 13 weeks of the program","description":"Although not powered to be able to detect clinically significant differences pre and post program completion, as part of standard of care families complete a battery of measures prior to and after their completion in the fit5 program. Family scores on these responses will be examined to see if trends show changes in a meaningful and clinically relevant direction.\r\nEating behaviors (EAH): Three Factor Eating Questionnaire - R18"},{"outcome_type":"secondary","measure":"The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires.","time_frame":"At the conclusion of the 13 weeks of the program","description":"Although not powered to be able to detect clinically significant differences pre and post program completion, as part of standard of care families complete a battery of measures prior to and after their completion in the fit5 program. Family scores on these responses will be examined to see if trends show changes in a meaningful and clinically relevant direction.\r\nPain symptoms: The Pain Frequency - Severity - Duration Scale"},{"outcome_type":"secondary","measure":"The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires.","time_frame":"At the conclusion of the 13 weeks of the program","description":"Although not powered to be able to detect clinically significant differences pre and post program completion, as part of standard of care families complete a battery of measures prior to and after their completion in the fit5 program. Family scores on these responses will be examined to see if trends show changes in a meaningful and clinically relevant direction.\r\nPain symptoms: The Adolescent Pediatric Pain Tool"},{"outcome_type":"secondary","measure":"The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires.","time_frame":"At the conclusion of the 13 weeks of the program","description":"Although not powered to be able to detect clinically significant differences pre and post program completion, as part of standard of care families complete a battery of measures prior to and after their completion in the fit5 program. Family scores on these responses will be examined to see if trends show changes in a meaningful and clinically relevant direction.\r\nSelf-confidence: Readiness Ruler"},{"outcome_type":"secondary","measure":"The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires.","time_frame":"At the conclusion of the 13 weeks of the program","description":"Although not powered to be able to detect clinically significant differences pre and post program completion, as part of standard of care families complete a battery of measures prior to and after their completion in the fit5 program. Family scores on these responses will be examined to see if trends show changes in a meaningful and clinically relevant direction.\r\nEating behaviors: Eating Behaviors Questionnaire"},{"outcome_type":"secondary","measure":"The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires.","time_frame":"At the conclusion of the 13 weeks of the program","description":"Although not powered to be able to detect clinically significant differences pre and post program completion, as part of standard of care families complete a battery of measures prior to and after their completion in the fit5 program. Family scores on these responses will be examined to see if trends show changes in a meaningful and clinically relevant direction.\r\nBehavior: The Pediatric Symptom Checklist 17 item (PSC-17)"},{"outcome_type":"secondary","measure":"The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires.","time_frame":"At the conclusion of the 13 weeks of the program","description":"Although not powered to be able to detect clinically significant differences pre and post program completion, as part of standard of care families complete a battery of measures prior to and after their completion in the fit5 program. Family scores on these responses will be examined to see if trends show changes in a meaningful and clinically relevant direction.\r\nQuality of life: Sizing me up"},{"outcome_type":"secondary","measure":"The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires.","time_frame":"At the conclusion of the 13 weeks of the program","description":"Although not powered to be able to detect clinically significant differences pre and post program completion, as part of standard of care families complete a battery of measures prior to and after their completion in the fit5 program. Family scores on these responses will be examined to see if trends show changes in a meaningful and clinically relevant direction.\r\nQuality of life: Sizing them up"},{"outcome_type":"secondary","measure":"The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires.","time_frame":"At the conclusion of the 13 weeks of the program","description":"Although not powered to be able to detect clinically significant differences pre and post program completion, as part of standard of care families complete a battery of measures prior to and after their completion in the fit5 program. Family scores on these responses will be examined to see if trends show changes in a meaningful and clinically relevant direction.\r\nPain symptoms: The Child Activity Limitations Interview questionnaire"},{"outcome_type":"secondary","measure":"The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires.","time_frame":"At the conclusion of the 13 weeks of the program","description":"Although not powered to be able to detect clinically significant differences pre and post program completion, as part of standard of care families complete a battery of measures prior to and after their completion in the fit5 program. Family scores on these responses will be examined to see if trends show changes in a meaningful and clinically relevant direction.\r\nPain symptoms: The Child Activity Limitations Interview questionnaire Parent version"},{"outcome_type":"secondary","measure":"The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires.","time_frame":"At the conclusion of the 13 weeks of the program","description":"Although not powered to be able to detect clinically significant differences pre and post program completion, as part of standard of care families complete a battery of measures prior to and after their completion in the fit5 program. Family scores on these responses will be examined to see if trends show changes in a meaningful and clinically relevant direction.\r\nPain symptoms: Pain Burden Interview"},{"outcome_type":"secondary","measure":"The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires.","time_frame":"At the conclusion of the 13 weeks of the program","description":"Although not powered to be able to detect clinically significant differences pre and post program completion, as part of standard of care families complete a battery of measures prior to and after their completion in the fit5 program. Family scores on these responses will be examined to see if trends show changes in a meaningful and clinically relevant direction.\r\nSleep: Adolescent Sleep-Wake Scale"},{"outcome_type":"secondary","measure":"The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires.","time_frame":"At the conclusion of the 13 weeks of the program","description":"Although not powered to be able to detect clinically significant differences pre and post program completion, as part of standard of care families complete a battery of measures prior to and after their completion in the fit5 program. Family scores on these responses will be examined to see if trends show changes in a meaningful and clinically relevant direction.\r\nMedical: Youth will have their height, weight, BMI and BMI z-score calculated pre and post program completion as well as an assessment of their medical comorbidities."}]}
{"nct_id":"NCT04234581","start_date":"2019-08-13","phase":"N/A","enrollment":59,"brief_title":"The Effect of Lysulin on Glycemic Control and Advanced Glycation","official_title":"The Effect of Lysulin on Glycemic Control and Advanced Glycation in Inadequately Controlled Type 2 Diabetes Mellitus: a Double Blinded Placebo Controlled Study","primary_completion_date":"2020-06-12","study_type":"Interventional","rec_status":"Terminated","completion_date":"2020-06-12","last_update":"2020-10-19","description":"The primary objective is to determine whether 12 weeks of treatment with Lysulin, compared to placebo, causes a reduction from baseline in the plasma levels of glucose, hemoglobin A1c (HbA1c) and Advanced Glycation Endproducts (AGEs) in patients with inadequately controlled type 2 diabetes mellitus. Secondary objectives include determining whether 12 weeks of treatment with Lysulin increases beta-cell function as measured by plasma C-peptide levels.","other_id":"1185","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":21,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Type 2 diabetes mellitus\r\n\r\n          -  HbA1c 7.5% and <10.0% within past 6 weeks on diet only or stable doses of oral\r\n             antihyperglycemic agents with or without insulin\r\n\r\n          -  stable body weight (< 5% change in last 3 months)\r\n\r\n          -  If on insulin therapy: < 20% variation in insulin units 6 weeks prior to the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Type 1 DM\r\n\r\n          -  current or recent use of supplements containing lysine, zinc or vitamin C\r\n\r\n          -  uncontrolled hypertension (blood pressure 160/90 mmHg)\r\n\r\n          -  kidney disease (serum creatinine GFR 50 mL/min)\r\n\r\n          -  major illness\r\n\r\n          -  severe gastrointestinal disease\r\n\r\n          -  pregnancy\r\n\r\n          -  liver function tests > 2.5 times normal values in the past 3 months\r\n\r\n          -  currently abusing alcohol or drugs, or have a history of alcohol or drug abuse that in\r\n             the investigator's opinion could cause the subject to be non-compliant; or have a\r\n             general history of non-compliance with medications\r\n      ","sponsor":"Juraj Koska","sponsor_type":"U.S. Fed","conditions":"Type 2 Diabetes","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Lysulin","description":"Participants will be randomly allocated for 3 months to LysulinTM (1,110 mg TID, i.e. 3.3 g/day) or matching placebo."}],"outcomes":[{"outcome_type":"primary","measure":"Fasting glucose","time_frame":"Baseline","description":"Fasting plasma glucose"},{"outcome_type":"primary","measure":"Fasting glucose","time_frame":"6 weeks","description":"Fasting plasma glucose"},{"outcome_type":"primary","measure":"Fasting glucose","time_frame":"12 weeks","description":"Fasting plasma glucose"},{"outcome_type":"primary","measure":"Hemoglobin A1c","time_frame":"Baseline","description":"Hemoglobin A1c measured by PVAHS pathology lab"},{"outcome_type":"primary","measure":"Hemoglobin A1c","time_frame":"12 weeks","description":"Hemoglobin A1c measured by PVAHS pathology lab"},{"outcome_type":"secondary","measure":"Fasting C-peptide","time_frame":"Baseline","description":"Plasma C-peptide measured by ELISA"},{"outcome_type":"secondary","measure":"Fasting C-peptide","time_frame":"12 weeks","description":"Plasma C-peptide measured by ELISA"},{"outcome_type":"secondary","measure":"CML","time_frame":"Baseline","description":"Nɛ-carboxymethyl lysine in plasma"},{"outcome_type":"secondary","measure":"CML","time_frame":"12 weeks","description":"Nɛ-carboxymethyl lysine in plasma"},{"outcome_type":"secondary","measure":"CEL","time_frame":"Baseline","description":"Nɛ-carboxyethyl lysine in plasma"},{"outcome_type":"secondary","measure":"CEL","time_frame":"12 weeks","description":"Nɛ-carboxyethyl lysine in plasma"},{"outcome_type":"secondary","measure":"GH1","time_frame":"Baseline","description":"Glyoxal hydroimidazolone in plasma"},{"outcome_type":"secondary","measure":"GH1","time_frame":"12 weeks","description":"Glyoxal hydroimidazolone in plasma"},{"outcome_type":"secondary","measure":"3DGH1","time_frame":"Baseline","description":"3-deoxyglucosone hydroimidazolone in plasma"},{"outcome_type":"secondary","measure":"3DGH1","time_frame":"12 weeks","description":"3-deoxyglucosone hydroimidazolone in plasma"},{"outcome_type":"secondary","measure":"MGH1","time_frame":"Baseline","description":"Methylglyoxal hydroimidazolone in plasma"},{"outcome_type":"secondary","measure":"MGH1","time_frame":"12 weeks","description":"Methylglyoxal hydroimidazolone in plasma"},{"outcome_type":"secondary","measure":"MetSO","time_frame":"Baseline","description":"Methionine sulfoxide in plasma"},{"outcome_type":"secondary","measure":"MetSO","time_frame":"12 weeks","description":"Methionine sulfoxide in plasma"},{"outcome_type":"secondary","measure":"2-AAA","time_frame":"Baseline","description":"2-aminoadipic acid in plasma"},{"outcome_type":"secondary","measure":"2-AAA","time_frame":"12 weeks","description":"2-aminoadipic acid in plasma"}]}
{"nct_id":"NCT04015778","start_date":"2019-08-08","phase":"Phase 2","enrollment":48,"brief_title":"A Two-arm (Phase 2) Exploratory Study of Nivolumab Monotherapy or in Combination With Nab-paclitaxel and Carboplatin in Early Stage NSCLC in China","official_title":"A Two-arm (Phase 2) Exploratory Study of Nivolumab Monotherapy or in Combination With Nab-paclitaxel and Carboplatin in Early Stage NSCLC in China","primary_completion_date":"2020-08-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2024-07-31","last_update":"2020-02-12","description":"Nivolumab (BMS-936558) is a fully human, IgG4 (kappa) isotype mAb that binds PD-1 on activated immune cells and disrupts engagement of the receptor with its ligands PD-L1 (B7 H1/CD274) and PD-L2 (B7-DC/CD273), thereby abrogating inhibitory signals and augmenting the host antitumor response. In early clinical trials, nivolumab has demonstrated activity in several tumor types, including melanoma, renal cell carcinoma (RCC), and non-small cell lung cancer (NSCLC). Nivolumab is in clinical development for the treatment of patients with NSCLC, RCC, melanoma, squamous cell carcinoma of the head and neck (SCCHN) and other tumors (eg, glioblastoma multiforme, mesothelioma, small cell lung cancer, gastric). Nivolumab is approved in the United States (US), European Union, and other countries for the treatment of patients with unresectable or metastatic melanoma, advanced NSCLC with progression on or after platinum-based chemotherapy, advanced RCC whose disease progressed on an antiangiogenic therapy, classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation brentuximab vedotin treatment, and recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy. The proposed study will evaluate the efficacy and safety of preoperative administration of Nivolumab or Nivolumab combined with nab-paclitaxel and carboplatin in neoadjuvant setting and administration of Nivolumab in adjuvant setting in patients with high-risk resectable NSCLC, and will facilitate a comprehensive exploratory characterization of the tumor immune microenvironment and circulating immune cells in these patients. Data obtained in this study will provide valuable information for planning further prospective clinical trials of anti-PD-1 and other immunotherapies in NSCLC, both in the peri-operative and advanced disease setting. Ultimately, it is highly desirable to discover prospective biomarkers of response and toxicity to allow patients with NSCLC who are most likely to derive benefit to receive anti-PD-1 treatment, and conversely to minimize the risk of toxicity and ineffective treatment for patients who are unlikely to benefit.","other_id":"CTONG 1804","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Early stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue\r\n\r\n          -  Lung function capacity capable of tolerating the proposed lung surgery\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1\r\n\r\n          -  Available tissue of primary lung tumor\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Presence of locally advanced, inoperable or metastatic disease\r\n\r\n          -  Participants with active, known or suspected autoimmune disease\r\n\r\n          -  Prior treatment with any drug that targets T cell co-stimulations pathways (such as\r\n             checkpoint inhibitors)\r\n\r\n        Other protocol defined inclusion/exclusion criteria could apply\r\n      ","sponsor":"Guangdong Association of Clinical Trials","sponsor_type":"Other","conditions":"Non Small Cell Lung Cancer","interventions":[{"intervention_type":"Biological","name":"Biological: Nivolumab","description":"240mg Q2W or 360mg Q3W"},{"intervention_type":"Drug","name":"Drug: carboplatin","description":"AUC 5, d1 every three weeks"},{"intervention_type":"Drug","name":"Drug: nab-paclitaxel","description":"135 mg/m2, d1, 8"}],"outcomes":[{"outcome_type":"primary","measure":"MPR rate","time_frame":"The patients considered to be technically resectable will undergo resection，an expected average of 13 weeks","description":"MPR rate, defined as number participants with <10% residual tumor in lung and lymph nodes, divided by the number of treated participants for each arm Viable tumors in situ carcinoma should not be included in MPR calculation."},{"outcome_type":"secondary","measure":"MPR rate in 2 subgroups patients (PD-L1 <1%, and 1-49%) in Arm B","time_frame":"The patients considered to be technically resectable will undergo resection，an expected average of 13 weeks"},{"outcome_type":"secondary","measure":"Proportion of resection without delay","time_frame":"The patients considered to be technically resectable will undergo resection，an expected average of 13 weeks"},{"outcome_type":"secondary","measure":"Number of Participants with Adverse Events","time_frame":"During the neoadjuvant period and 100 days post adjuvant period","description":"Safety and tolerability will be measured by incidence of AE, SAE, immune related AEs, deaths, and laboratory abnormalities"}]}
{"nct_id":"NCT04179344","start_date":"2019-08-05","enrollment":25,"brief_title":"Usability Study of IeHS in Indonesia","official_title":"The Usability Testing of the IeHS (Integrated E-healthcare Services) Web-based Application in the Therapy Management of HIV and Tuberculosis in Indonesia: a Concurrent Nested Study Design","primary_completion_date":"2019-10-31","study_type":"Observational","rec_status":"Completed","completion_date":"2019-10-31","last_update":"2019-11-27","description":"Technology that has a particular focus on patients' needs and ease-of-use and -access plays a significant role in the development of e-health and m-health. The proposed model of a secured mobile health application may promote patient's self-management and enhances adherence in chronic therapy exactly as it is easy-to-use, reducing patient's burden in accessing medication information and instructions, and providing the opportunity for direct communications with health providers in charge for each patient with access to mobile technologies. Consequently, medication errors and unnecessary paperwork in the healthcare system will be avoided as well as giving more time for healthcare providers to pay greater attention to delivering medical care effectively and efficiently.","other_id":"IeHS_Indonesia","observational_model":"Other","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Adults males or females involved in HIV and TB treatment, i.e. physicians, pharmacists, HIV\r\n        and/or TB patients.","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Males or females age 18 years old or more;\r\n\r\n          2. Acting as one of the following users: pulmonologist, internist, GP, pharmacists, and a\r\n             patient who suffers from TB and/or HIV;\r\n\r\n          3. In case of a patient user: on drug treatment;\r\n\r\n          4. Use a smartphone and know how to use it;\r\n\r\n          5. Familiar with technology, particularly ICT;\r\n\r\n          6. Understand basic english;\r\n\r\n          7. Able to speak and communicate in Bahasa Indonesia;\r\n\r\n          8. Willing to participate and sign informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. A severe clinical condition that might impair the hearing or the seeing;\r\n\r\n          2. Unwillingness to participate.\r\n      ","sponsor":"Bekasi City Public Hospital","sponsor_type":"Other","conditions":"Human Immunodeficiency Virus|Tuberculosis|Interpersonal Relations|Mobile Phone Use|Adult","interventions":[{"intervention_type":"Other","name":"Other: Integrated e-healthcare services (IeHS) web-based app","description":"Each participant is asked to complete study tasks using the IeHS web-based app as a part of IeHS simulation. This activity is followed by user experience survey, and an in-depth interview to explore user satisfaction on the IeHS web-based app"}],"outcomes":[{"outcome_type":"primary","measure":"Tasks completion success","time_frame":"during the simulation for each participant in 3 months of study period","description":"Effectiveness is defined by task completion success numbers of errors occur during the web-app simulation"},{"outcome_type":"primary","measure":"Numbers of tasks errors","time_frame":"during the simulation for each participant in 3 months of study period","description":"Effectiveness is defined by task completion success numbers of errors occur during the web-app simulation"},{"outcome_type":"primary","measure":"Average time to complete each task","time_frame":"during the simulation for each participant in 3 months of study period","description":"Efficiency is defined as level of efforts use by the study participant to complete the web-app simulation each task."},{"outcome_type":"primary","measure":"system usability scale (SUS) score","time_frame":"after half-an-hour of the web-app simulation during 3 months of study period","description":"IeHS satisfaction is defined through the SUS questionnaire which allows measurements of overall usability, allowing comparisons across a range of contexts and systems. SUS score is ranged from 0 (worst) to 100 (perfect)."},{"outcome_type":"secondary","measure":"Participant experience using the IeHS web-based app","time_frame":"half an hour after web-based app simulation during 3 months of study period","description":"Participants/users are asked about their experiences and perceptions after the simulation regarding to the effectiveness, efficiency, satisfaction, obstacles, and IeHS potential use. These arguments will be collected qualitatively through in-depth interview."}]}
{"nct_id":"NCT03765359","start_date":"2019-08-05","phase":"Phase 4","enrollment":200,"brief_title":"Metformin Use to Improve Pregnancy Outcome in Women With Type 1 Diabetes.","official_title":"Metformin Use to Improve Pregnancy Outcome in Women With Type 1 Diabetes. A Randomized Double-blind Placebo-controlled Multicenter Study.","primary_completion_date":"2022-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-12-31","last_update":"2019-12-18","description":"The study investigates whether additional metformin medication in combination with regular insulin treatment will decrease the need of insulin for women with diabetes mellitus type 1 during pregnancy.","other_id":"Diabetes2017","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"Female","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  a pregnancy of a woman with type 1 diabetes.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  multiple pregnancy, significant underlying disease (hearth disease, kidney transplant,\r\n             IBD (inflammatory bowel disease ), SLE (systemic lupus erythematosus ), diseases with\r\n             use of high dosage corticosteroids (severe asthma or rheumatic disease), severe\r\n             complications of diabetes (nephropathy, neuropathy, gastroparesis or severe\r\n             retinopathy), substance abuse, smoking, BMI <18, strong early pregnancy nausea\r\n             (=hyperemesis)\r\n      ","sponsor":"Tampere University Hospital","sponsor_type":"Other","conditions":"Diabetic Pregnancy|Insulin Resistance|Type1diabetes","interventions":[{"intervention_type":"Drug","name":"Drug: metforminhydrochloride","description":"metformin 500 mg tablets and insulin"},{"intervention_type":"Drug","name":"Drug: Placebo Oral Tablet","description":"Placebo tablets mimic metformin 500 mg tablets and insulin"}],"outcomes":[{"outcome_type":"secondary","measure":"macrosomia","time_frame":"from gestational weeks 20 until the delivery","description":"estimated fetal weight in ultrasound (grams)"},{"outcome_type":"secondary","measure":"Pregnancy complications","time_frame":"12-22 weeks of gestation","description":"incidence of miscarriage (intrauterine death before 22 weeks of gestation or fetal weigth under 500g) (%)"},{"outcome_type":"secondary","measure":"Pregnancy complications","time_frame":"22-40 weeks of gestation","description":"incidence of intrauterine death (intrauterine death after 22 weeks of gestation or fetal weigth over 500g) (%)"},{"outcome_type":"secondary","measure":"Pregnancy complications","time_frame":"from gestational weeks 5 until the delivery","description":"Incidence proteinuria (mg/mmol or mg/d)"},{"outcome_type":"secondary","measure":"Cost benefit calculations (hospitalization)","time_frame":"14-40 weeks of gestation","description":"The need of hospitalization during pregnancy (days/pregnancy)"},{"outcome_type":"primary","measure":"Changes in the insulin need during pregnancy","time_frame":"from 5-10 gestational weeks until the delivery","description":"The insulin dosage (IU/ml) in two weeks sets"},{"outcome_type":"secondary","measure":"Blood glucose balance during pregnancy","time_frame":"from gestational weeks 5 until the delivery","description":"HbA1c (mmol/mol)"},{"outcome_type":"secondary","measure":"Blood glucose balance during pregnancy","time_frame":"from gestational weeks 5 until the delivery","description":"mean blood glucose (mmol/l) level, standard deviation (SD) and the coefficient of variation of the blood glucose levels"},{"outcome_type":"secondary","measure":"Change in the weight","time_frame":"from gestational weeks 5 until the delivery","description":"Weight gain (g) during pregnancy"},{"outcome_type":"secondary","measure":"Change in the blood pressure","time_frame":"from gestational weeks 5 until the delivery","description":"Blood pressure (mmHg)"},{"outcome_type":"secondary","measure":"Incidence of pre-eclampsia","time_frame":"from gestational weeks 20 until the delivery","description":"Incidence of pre-eclampsia (%)"},{"outcome_type":"secondary","measure":"Incidence hepatogestosis","time_frame":"from gestational weeks 20 until the delivery","description":"Incidence hepatogestosis (%)"},{"outcome_type":"secondary","measure":"Thigh fractional volume ultrasound","time_frame":"from gestational weeks 20 until delivery","description":"Fetal weight estimation (g) is specified by thigh fractional volume ultrasound program"},{"outcome_type":"secondary","measure":"Rate of the caesarean sections","time_frame":"The delivery","description":"Rate of the caesarean sections (%)"},{"outcome_type":"secondary","measure":"Labour","time_frame":"The delivery","description":"rate of spontaneous delivery (%)"},{"outcome_type":"secondary","measure":"Rate of the operative vaginal deliveries","time_frame":"The delivery","description":"Rate of the operative vaginal deliveries (%)"},{"outcome_type":"secondary","measure":"Rate of the shoulder dystocia","time_frame":"The delivery","description":"Rate of the shoulder dystocia (%)"},{"outcome_type":"secondary","measure":"Labor complications","time_frame":"The delivery","description":"rate of induced delivery (%)"},{"outcome_type":"secondary","measure":"Rate of the perineal tears","time_frame":"The delivery","description":"Rate of the perineal tears (%)"},{"outcome_type":"secondary","measure":"Postpartum bleeding","time_frame":"The delivery","description":"postpartum bleeding (ml)"},{"outcome_type":"secondary","measure":"Newborn variables (gestational age)","time_frame":"After the delivery","description":"Rate of the premature deliveries (=deliveries before 37 weeks of gestation) (%)"},{"outcome_type":"secondary","measure":"Newborn variables","time_frame":"After the delivery","description":"weight of the newborn (g)"},{"outcome_type":"secondary","measure":"Newborn outcome","time_frame":"After the delivery","description":"Acidosis of the newborn (pH)"},{"outcome_type":"secondary","measure":"Newborn outcome (intensive care)","time_frame":"After the delivery","description":"The need of NICU (neonatal intensive care unit) treatment (days)"},{"outcome_type":"secondary","measure":"Newborn outcome (hypoglycemia)","time_frame":"After the delivery","description":"The occurrence of hypoglycemia (=plasma glucose under 2.6mmol/l or usage of iv glucose infusion) (%)"},{"outcome_type":"secondary","measure":"Newborn outcome (Erb's)","time_frame":"After the delivery","description":"Incidence of the Erb's paresis (%)"},{"outcome_type":"secondary","measure":"Cost benefit calculations (sick leaves)","time_frame":"from gestational weeks 12 until delivery","description":"The need of sick leaves during pregnancy (days)"},{"outcome_type":"secondary","measure":"Cost benefit calculations (visits to maternity outpatient clinic or internal medicine policlinic)","time_frame":"14-40 weeks of gestation","description":"The need of polyclinical controls during pregnancy (number of visits/pregnancy)"},{"outcome_type":"secondary","measure":"Cost benefit calculations (all outpatient visits after delivery )","time_frame":"One year after the delivery","description":"The need of policlinical controls of the diabetic mother after the delivery (number of visits)"},{"outcome_type":"secondary","measure":"Cost benefit calculations (hospitalization after delivery, all departments)","time_frame":"Up to one year after the delivery","description":"The need of hospitalization of the diabetic mother after the delivery (days)"},{"outcome_type":"secondary","measure":"Cost benefit calculations (all hospitalization of the child)","time_frame":"Until the age of one year","description":"The need of hospitalization of the child (days)"},{"outcome_type":"secondary","measure":"Cost benefit calculations (all policlinical controls of the child)","time_frame":"Until the age of one year","description":"The need of policlinical controls of the child (number of visits)"},{"outcome_type":"secondary","measure":"high sensitive-CRP","time_frame":"7-10, 26-28 and 34-36 weeks of gestation","description":"high sensitive-CRP (mg/l)"},{"outcome_type":"secondary","measure":"lipids","time_frame":"7-10, 26-28 and 34-36 weeks of gestation","description":"cholesterol, high density lipoprotein, low density lipoprotein, triglyserids (mmol/l)"},{"outcome_type":"secondary","measure":"Inflammatory markers","time_frame":"7-10, 26-28 and 34-36 weeks of gestation","description":"adiponectin, leptin, resistin, IL-6, TNF-α (pg/ml)"}]}
{"nct_id":"NCT04042805","start_date":"2019-08-01","phase":"Phase 2","enrollment":36,"brief_title":"Sintilimab Combined With Lenvatinib in Local Advanced Hepatocellular Carcinoma","official_title":"Sintilimab Combined With Lenvatinib in Local Advanced Hepatocellular Carcinoma: A Single-arm, Open-label, Phase II Clinical Study","primary_completion_date":"2022-08-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2024-08-30","last_update":"2021-03-02","description":"This ia a single-arm, single-center, not-randomized, open-label phase II study. The purpose of this study is to evaluate the efficacy and safety of Sintilimab (PD-1 antibody) combined with Lenvatinib(TKI) for the treatment of local advanced hepatocellular carcinoma.","other_id":"2019088","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":100,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Has a diagnosis of hepatocellular carcinoma confirmed by radiology, histology, or\r\n             cytology\r\n\r\n          -  Barcelona Clinic Liver Cancer (BCLC) Stage C disease without any distant or lymphatic\r\n             metastasis , or BCLC Stage B disease not amenable to curative surgery\r\n\r\n          -  No previous systemic anticancer treatment or TACE treatment\r\n\r\n          -  Age 18 years\r\n\r\n          -  ECOG performance status: 0-1\r\n\r\n          -  Child Pugh score7\r\n\r\n          -  Has at least one measurable hepatocellular carcinoma (HCC) lesion based on RECIST 1.1\r\n\r\n          -  Life expectancy 12 weeks.\r\n\r\n          -  Patients must be able to understand and willing to sign a written informed consent\r\n             document\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Fibrous lamina hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma,\r\n             cholangiocarcinoma\r\n\r\n          -  History of hepatic encephalopathy or liver transplantation\r\n\r\n          -  Pleural effusion, ascites and pericardial effusion with clinical symptoms or needing\r\n             drainage.\r\n\r\n          -  Untreated hepatitis infection: HBV DNA>2000IU/mlor10000 copy/ml, HCV RNA> 1000copy/ml,\r\n             both HbsAg and anti-HCV body are positive.\r\n\r\n          -  Patients with clinically significant gastrointestinal bleeding within 30 days prior to\r\n             study entry.\r\n\r\n          -  History of symptomatic interstitial lung disease or other conditions that may cause\r\n             confusion when discovering or managing suspicious drug-related lung toxicity\r\n\r\n          -  With serious systemic diseases such as heart disease and cerebrovascular disease, and\r\n             the condition is unstable or uncontrollable.\r\n\r\n          -  Evidence of active pulmonary tuberculosis (TB).\r\n\r\n          -  Positive test of immunodeficiency virus (HIV) or acquired immunodeficiency syndrome\r\n             (AIDS)\r\n\r\n          -  History of allergic reactions to related drugs\r\n\r\n          -  Pregnant women, nursing mothers\r\n      ","sponsor":"Baocai Xing","sponsor_type":"Other","conditions":"Hepatocellular Carcinoma","interventions":[{"intervention_type":"Biological","name":"Biological: Sintilimab","description":"200mg intravenously every 3 weeks"},{"intervention_type":"Drug","name":"Drug: Lenvatinib","description":"12 mg (or 8 mg) once daily (QD) oral dosing."}],"outcomes":[{"outcome_type":"primary","measure":"Objective Response Rate (ORR)","time_frame":"1 year after the last patient's enrollment"},{"outcome_type":"secondary","measure":"Overall Survival","time_frame":"2 years after the last patient's enrollment"},{"outcome_type":"secondary","measure":"Safety of combination sintilimab and lenvatinib as evaluated by incidence of adverse events(AEs), serious adverse events (SAEs).","time_frame":"2 years after the last patient's enrollment"},{"outcome_type":"secondary","measure":"Conversion rate to surgery","time_frame":"1 year after the last patient's enrollment","description":"Conversion rate defined as the proportion of participants be able to receive surgery after the initiation of the study treatment"},{"outcome_type":"secondary","measure":"Tumor mutation burden in association with ORR and survival.","time_frame":"1 year after the last patient's enrollment","description":"It will be performed by NGS."}]}
{"nct_id":"NCT04015726","start_date":"2019-08-01","enrollment":2815,"brief_title":"Secular Trends in the Prevalence of Cardiometabolic Risk Factors Among Teenage School Children in Urban South India","official_title":"Secular Trends in the Prevalence of Cardiometabolic Risk Factors Among Teenage School Children in Urban South India","primary_completion_date":"2021-08-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2021-12-31","last_update":"2020-11-24","description":"The prevalence of cardiometabolic risk is high among South Asians which manifests itself at an early age. Studies have reported that unhealthy food choices, inadequate physical activity and lack of awareness on healthy lifestyle practices pose a huge threat to the increasing prevalence of metabolic abnormalities even at adolescence. In an earlier study conducted in 2006, reported that 68% of the children during their early adolescence had one or more of the cardiometabolic abnormalities such as obesity, central adiposity, increased blood pressure and presence of dysglycaemia and dyslipidaemia. The risk escalated with increasing weight. Therefore, it is imperative to sensitize the children on improving their lifestyle by conducting screening tests and health education programmes in schools by involving teachers. The Investigator have also shown in a study that teachers can be instrumental in imparting knowledge on the prevention of non-communicable diseases such as diabetes by promoting healthy behavioral changes. The proposed study will focus on a) changes in the prevalence of cardiometabolic risk factors over a 10 year period b) health education programme to school children c) recommendations to school teachers (tool-kit) to inculcate improved lifestyle practices to their students.","other_id":"IDRFARH012","observational_model":"Other","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":12,"maximum_age":18,"population":"Children both boys and girls between 12 - 18yrs age group","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Children both boys and girls between 12 - 18yrs age group\r\n\r\n          2. Parents and child willing to give informed consent\r\n\r\n          3. Children must be available for and willing to attend all evaluation visits\r\n\r\n          4. Willingness to follow the protocol requirements as evidenced by written informed\r\n             consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Children below the age of 12 years and above the age of 18 years\r\n\r\n          2. Parents or Child who is not willing to participate in the study\r\n      ","sponsor":"India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals","sponsor_type":"Other","conditions":"Dysglycemia|Obesity|Dyslipidemias|Hypertension|Insulin Resistance","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Prevalence of central adiposity","time_frame":"baseline","description":"Among adolescent children in 2019 in comparison with 2006 data"},{"outcome_type":"primary","measure":"Prevalence of dysglycemia","time_frame":"Baseline","description":"Among adolescent children in 2019 in comparison with 2006 data"},{"outcome_type":"primary","measure":"Prevalence of dyslipidemia","time_frame":"Baseline","description":"Among adolescent children in 2019 in comparison with 2006 data"},{"outcome_type":"primary","measure":"Prevalence of hypertension","time_frame":"Baseline","description":"Among adolescent children in 2019 in comparison with 2006 data"},{"outcome_type":"primary","measure":"Prevalence of insulin resistance","time_frame":"Baseline","description":"Among adolescent children in 2019 in comparison with 2006 data"},{"outcome_type":"secondary","measure":"Prevalence of overweight","time_frame":"Baseline","description":"Among adolescent children in 2019 in comparison with 2006 data"},{"outcome_type":"secondary","measure":"Prevalence of obesity","time_frame":"Baseline","description":"Among adolescent children in 2019 in comparison with 2006 data"},{"outcome_type":"secondary","measure":"Changes in diet habit","time_frame":"Baseline","description":"Among adolescent children in 2019 in comparison with 2006 data"},{"outcome_type":"secondary","measure":"Changes in duration of physical activity","time_frame":"Baseline","description":"Among adolescent children in 2019 in comparison with 2006 data"}]}
{"nct_id":"NCT04027751","start_date":"2019-08-01","phase":"Phase 4","enrollment":1508,"brief_title":"The Efficacy and Safety of Tropisetron in Preventing Emergence Delirium","official_title":"The Efficacy and Safety of Tropisetron in Preventing Emergence Delirium: A Randomized Controlled Trial","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-03-31","last_update":"2020-03-11","description":"The purpose of this study is to determine the efficacy and safety of Tropisetron in preventing emergence delirium.","other_id":"04719372","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Written consent given\r\n\r\n          2. Scheduled to undergo elective non-cardiac surgeries under general anesthesia\r\n\r\n          3. ASA Physical Score I-III\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients with a history of neurological disease, such as Alzheimer disease.\r\n\r\n          2. Patients with a history of psychiatric disease\r\n\r\n          3. Patients with a medication history of antipsychotic drugs over the last 30 days prior\r\n             to enrollment.\r\n\r\n          4. Unable to complete neuropsychological testing including patients with severe visual or\r\n             hearing impairment.\r\n\r\n          5. the Montreal Cognitive Assessment (MoCA) scores below 10\r\n\r\n          6. Patients who have severe intraoperative adverse events, such as cardiac arrest.\r\n\r\n          7. Patients with contraindication of tropisetron.\r\n      ","sponsor":"Beijing Chao Yang Hospital","sponsor_type":"Other","conditions":"Emergence Delirium|Postoperative Delirium","interventions":[{"intervention_type":"Drug","name":"Drug: Tropisetron","description":"Investigators administrated intravenously Tropisetron 5mg before anesthesia induction"},{"intervention_type":"Drug","name":"Drug: Placebos","description":"Investigators administrated intravenously 0.9% saline solution as a placebo"}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of emergence delirium","time_frame":"Until the end of post-anesthesia care unit stay, assessed up to 1 hour","description":"Screening of the patients regarding an emergence delirium by The Confusion Assessment Method for The Intensive Care Unit (CAM-ICU). CAM-ICU is assessed at three different points of time:\r\n15min after excubation\r\n30min after excubation\r\nAt discharge from post-anesthesia care unit (PACU)"},{"outcome_type":"secondary","measure":"Incidence of postoperative delirium","time_frame":"Within 3 days after surgery","description":"Screening of the patients regarding a postoperative delirium by The Confusion Assessment Method for The Intensive Care Unit (CAM-ICU)"},{"outcome_type":"secondary","measure":"Incidence of postoperative nausea and vomiting","time_frame":"Within 3 days after surgery"},{"outcome_type":"secondary","measure":"Postoperative Pain","time_frame":"Within 3 days after surgery","description":"Visual Analogue Scale will be used to assess postoperative pain of patients. Numerical rating scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain."},{"outcome_type":"secondary","measure":"Length of Hospital stay","time_frame":"From the date of admission until discharged from hospital, up to 30 days"},{"outcome_type":"secondary","measure":"Adverse events","time_frame":"Within 3 days after surgery","description":"Other adverse events within 3 days after surgery were noted"}]}
{"nct_id":"NCT03948932","start_date":"2019-08-01","enrollment":100,"brief_title":"Cervix Uteri \"Resistance\" Measurements","official_title":"Cervical \"Resistance\" Measurements - a Novel Method for Evaluation of Cervical \"Ripeness\" Prior to Labor Induction","primary_completion_date":"2021-12-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2022-04-01","last_update":"2020-09-16","description":"Pregnant women at term, after 37 weeks' gestation will undergo cervical ripening for labor induction via cervical ripening balloon. Transvaginal sonography will be performed before balloon insertion. During balloon insertion and after uterine balloon inflation a pressure watch will be attached to the balloon and inflation pressures of the vaginal balloon will be measured and documented.","other_id":"0246-16-RMB","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"Female","minimum_age":18,"maximum_age":44,"population":"Pregnant women between 24-42 weeks gestation that are candidates for labor induction with a\r\n        cervical ripening balloon.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Obstetrical or medical indication for induction of labor\r\n\r\n          -  Unfavorable cervix\r\n\r\n          -  Gestational age between 24 - 42 weeks\r\n\r\n          -  Singleton pregnancy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any contraindication for vaginal delivery\r\n\r\n          -  Rupture of membranes\r\n\r\n          -  Fetal malformations incompatible with life\r\n\r\n          -  Amnionitis\r\n\r\n          -  Genital viral infection (HIV, HCV, HBV)\r\n      ","sponsor":"Rambam Health Care Campus","sponsor_type":"Other","conditions":"Induction of Labor Affected Fetus / Newborn","interventions":[{"intervention_type":"Device","name":"Device: Transvaginal sonography","description":"Measurement of cervical length via transvaginal sonography prior to labor induction."},{"intervention_type":"Device","name":"Device: Pressure watch","description":"Measurement of inflation pressure in a cervical ripening balloon is PSI units."}],"outcomes":[{"outcome_type":"primary","measure":"Volume versus pressure","time_frame":"From patient admission up to 24 hours postpartum.","description":"To define pressure versus volume characteristics of the expanding uterine cervical balloon."}]}
{"nct_id":"NCT04349397","start_date":"2019-08-01","enrollment":100,"brief_title":"Use of Analgesics and Pain Scores After Pediatric Adenotonsillectomy","official_title":"Use of Analgesics and Pain Scores After Pediatric Adenotonsillectomy","primary_completion_date":"2020-12-31","study_type":"Observational","rec_status":"Active, not recruiting","completion_date":"2021-06-30","last_update":"2020-04-16","description":"The purpose of the study is to quantify the use of pain medications given to children aged 3 - 12 years as well as their pain level through pain scores after they have undergone a tonsillectomy or adenotonsillectomy surgery at Doernbecher Children's Hospital (DCH). We would like to learn more about the pain medications given and the pain scores of children post-surgery for the first 5 days following discharge from the hospital.","other_id":"19199","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":3,"maximum_age":12,"population":"1. Parent or guardian refusal of consent\r\n\r\n          2. Child has severe OSA (Apnea-Hypopnea Index (AHI) 10 or O2 Saturation <85% on\r\n             polysomnogram)\r\n\r\n          3. Child with behavioral disorders (ADHD, ASD, etc.)\r\n\r\n          4. Child with genetic disorders (down syndrome, mucopolysaccharidoses, achondroplasia,\r\n             Prader-Willi syndrome, etc.)\r\n\r\n          5. Child with neuromuscular disorders (muscular dystrophy, hypotonia, etc.)\r\n\r\n          6. Child with a history of extremely preterm (born at <28 weeks) or very preterm (born at\r\n             28-32 weeks)\r\n\r\n          7. Child with moderate to severe developmental delay\r\n\r\n          8. Child is obese (BMI  95th percentile)\r\n\r\n          9. Child with craniofacial anomalies (retrognathia, micrognathia, midface hypoplasia)\r\n\r\n         10. Child with allergies to acetaminophen, ibuprofen, morphine, fentanyl or oxycodone","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Child aged 3-12 that is scheduled to undergo tonsillectomy or adenotonsillectomy, with\r\n             or without ear tubes or Parent or guardian of a child aged 3-12 years old that is\r\n             scheduled to undergo tonsillectomy or adenotonsillectomy, with or without ear tubes\r\n\r\n        Exclusion Criteria:\r\n\r\n        -\r\n      ","sponsor":"Oregon Health and Science University","sponsor_type":"Other","conditions":"Pain, Postoperative|Obstructive Sleep Apnea of Child","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Medication Tracking Form","description":"Parents will complete medication tracking form for 5 days after child's surgery. They will track medications administered, pain scores, nausea and vomiting"}],"outcomes":[{"outcome_type":"secondary","measure":"Frequency of Vomiting on POD 1-5","time_frame":"POD 1-5","description":"Number of days vomiting on POD 1-5"},{"outcome_type":"secondary","measure":"Duration of impaired drinking","time_frame":"POD 1-5","description":"Return to normal drinking on POD 1-5"},{"outcome_type":"secondary","measure":"Duration of impaired eating","time_frame":"POD 1-5","description":"Return to normal eating on POD 1-5"},{"outcome_type":"secondary","measure":"Duration of impaired activity","time_frame":"POD 1-5","description":"Return to normal activity on POD 1-5"},{"outcome_type":"primary","measure":"Total opioid administered during POD 1-5 (converted to morphine dose equivalents)","time_frame":"POD 1-5","description":"Total amount of opioid analgesics administered at home on Post-operative days 1-5."},{"outcome_type":"secondary","measure":"Mean Worst Pain Scores POD 1-5","time_frame":"POD 1-5","description":"Average of worst pain scores as documented twice a day on POD 1-5"},{"outcome_type":"secondary","measure":"Total acetaminophen administered on POD 1-5","time_frame":"POD 1-5","description":"Total acetaminophen given (total dose and total quantity as mg/kg)"},{"outcome_type":"secondary","measure":"Total ibuprofen administered on POD 1-5","time_frame":"POD 1-5","description":"Total ibuprofen given (total dose and total quantity as mg/kg)"}]}
{"nct_id":"NCT04053933","start_date":"2019-08-01","enrollment":350,"brief_title":"Observational Study Towards the Impact of Newly Started Treatment in MDS on QoL","official_title":"A Multicenter Observational Belgian Study Assessing the Impact of Newly Started Treatment on the QOL in Patients Suffering From Myelodysplastic Syndromes.","primary_completion_date":"2021-09-01","study_type":"Observational [Patient Registry]","rec_status":"Recruiting","completion_date":"2022-02-01","last_update":"2019-08-13","description":"Study type An observational study conducted in different hematological centers in Belgium. Study objectives Primary objective: To assess the impact of newly started treatments on the QOL of patients suffering from myelodysplastic syndromes. Secondary objectives: - To assess the impact of newly started therapy on disease perception in MDS patients - To study the relation between disease perception and quality of life - To examine which clinical and disease specific factors determine QOL in MDS patients - Collect information on the transfusion threshold in Belgian hematological centers and evaluate the impact on quality of life. - To evaluate whether changes in QOL are related to hematological respons. Study design - Newly diagnosed MDS patients who are about to start a treatment or previously diagnosed MDS patients who are starting with a new line of therapy. - QOL assessment with the QUALMS. - Disease perception measurement using the B-IPQ. - Measurement at diagnosis/before start of therapy, at 4 weeks, 12 weeks, and at 24 weeks into treatment. Study endpoints Primary endpoint: Change in QUALMS score at visit timepoints 4 - 12 - 24 weeks after the start of a new treatment. Secondary endpoint: - Change in B-IPQ score at visit timepoints 4 - 12 - 24 weeks after the start of a new treatment - Association between B-IPQ and QUALMS score. - Association between clinical and disease specific factors and QUALMS score - Association between transfusion threshold and QUALMS score. - Association between hematological response and QUALMS score Summary of eligibility criteria - Adult patients with a new diagnosis of MDS (according to WHO 2016 definitions (3) or known patients with MDS who are about to start a new treatment. - Signed informed consent. - Patients enrolled in an unblinded interventional therapeutic trial are eligible. Exclusion criteria - Patients with acute leukemia defined as >20% bone marrow blasts. - Patients suffering from an overlap syndrome myelodysplastic/myeloproliferative disease. - Patients in post allogeneic transplant setting. - Patients enrolled in a blinded interventional therapeutic trial. - Patients starting with multiple treatments under investigation at the same moment apart from intensive chemotherapy. - Newly diagnosed patients who do not start with treatment. - Patients who started a previous treatment less then 12 weeks ago apart from packed cell transfusion (up to 4 weeks allowed). - Diagnosis of any previous or concomitant malignancy except when the patient successfully completed treatment (chemotherapy and/or surgery and/or radiotherapy) with curative intent for this malignancy at least 3 months prior to inclusion. - Patients refusing to sign informed consent.","other_id":"B300201938708","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients suffering from myelodysplastic syndromes","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Newly diagnosed patients with myelodysplastic syndromes defined by WHO 2016 criteria\r\n             that are about to start treatment.\r\n\r\n          -  Patients with a known diagnosis of MDS, irrespective of IPSS and irrespective of time\r\n             of diagnosis that are about to start a new therapy.\r\n\r\n          -  Signed informed consent\r\n\r\n        Exclusion criteria\r\n\r\n          -  Patients with acute leukemia defined as >20% bone marrow blasts.\r\n\r\n          -  Patients suffering from a myelodysplastic/myeloproliferative overlap syndrome. In this\r\n             case the disease has both dysplastic and proliferative features but cannot be properly\r\n             categorized to either group. This category includes chronic myelomonocytic leukemia\r\n             (CMML), juvenile myelomonocytic leukemia (JMML), atypial chronic myeloid leukemia\r\n             (aCML) and myelodysplastic/myeloproliferative disease unclassifiable.\r\n\r\n          -  Patients in post allogeneic transplant setting.\r\n\r\n          -  Patients enrolled in a blinded interventional therapeutic trial.\r\n\r\n          -  Patients starting with multiple MDS treatments at the same moment apart from intensive\r\n             chemotherapy.\r\n\r\n          -  Newly diagnosed patients who do not start with treatment.\r\n\r\n          -  Patients who started a previous MDS related treatment less then 4 weeks ago.\r\n\r\n          -  Patients who started a previous MDS related treatment less then 12 weeks ago apart\r\n             from packed cell transfusions.\r\n\r\n          -  Diagnosis of any previous or concomitant malignancy except when the patient\r\n             successfully completed treatment (chemotherapy and/or surgery and/or radiotherapy)\r\n             with curative intent for this malignancy at least 3 months prior to inclusion.\r\n\r\n          -  Patients refusing to sign informed consent\r\n      ","sponsor":"University Hospital, Antwerp","sponsor_type":"Other","conditions":"Myelodysplastic Syndromes","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Change in QUALMS-score","time_frame":"6 months","description":"Change in quality of life-score after the start of a new MDS related treatment"},{"outcome_type":"primary","measure":"Change in IPQ-score","time_frame":"6 months","description":"Change of ilness perception score after the start of a new MDS related treatment"}]}
{"nct_id":"NCT03893318","start_date":"2019-07-30","phase":"Phase 4","enrollment":70,"brief_title":"IV Lidocaine in Pediatric AIS","official_title":"Intravenous Lidocaine to Reduce Postoperative Opioid Consumption and Improve Recovery After Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis","primary_completion_date":"2022-12-31","study_type":"Interventional","rec_status":"Enrolling by invitation","completion_date":"2023-07-31","last_update":"2020-11-25","description":"This study addresses the focus areas of Post-Operative Pain Management. We propose a randomized, triple-blind, placebo-controlled trial to investigate the efficacy of a systemic infusion of intravenous lidocaine as a non-opioid method of post-operative pain management following postoperative spinal fusion for adolescent idiopathic scoliosis (AIS). The outcomes assessed will be (1) the effect of intravenous lidocaine on post-operative opioid consumption, both in-hospital and at three-month follow-up, (2) the effect of intravenous lidocaine on the immunophenotype expressed following surgery, and (3) the effect of intravenous lidocaine on recovery from surgery as assessed by the Patient Reported Outcomes Measurement Information System-Computer Adaptive Tests for Pain Interference (PI) and Mobility (M) (PROMIS-CAT). Thus, we propose a study of a non-opioid method of pain control to minimize opioid consumption in-hospital and at three-months postoperatively, with primary outcomes measures that include morphine-equivalent opioid consumption and PROMIS-Mobility to assess recovery. In addition, we will test the ability of systemic lidocaine to attenuate the systemic inflammatory response to major spine surgery. The immunologic response to surgery has been associated with rehabilitation and recovery following total hip arthroplasty and this study will provide data to support further work.","other_id":"201807071","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","intervention_model_description":"a randomized, triple-blind, placebo-controlled trial of intravenous lidocaine in the management of surgery performed for adolescent idiopathic scoliosis.","sampling_method":"","gender":"All","minimum_age":12,"maximum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Adolescent idiopathic scoliosis indicated for posterior spinal fusion.\r\n\r\n          2. Ages between 12 and 18 years of age.\r\n\r\n          3. Parent/Guardian capable of providing informed consent for study participation\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Age < 12 or > 18 years old.\r\n\r\n          2. Unable to obtain consent for the surgical intervention or study, or if mental capacity\r\n             prohibits the ability to provide consent and complete patient-reported outcomes tools.\r\n\r\n          3. Diagnosis of sepsis or infection\r\n\r\n          4. Diagnosis of primary or metastatic malignancy.\r\n\r\n          5. Participation in another clinical trial.\r\n\r\n          6. Past or current diagnoses of a cardiac arrhythmia or first/second degree heart block.\r\n\r\n          7. Past or current seizure disorders.\r\n\r\n          8. Allergy to bupivacaine.\r\n\r\n          9. Planned anterior approaches for treatment of scoliosis deformity.\r\n\r\n         10. Limited English proficiency (e.g. unable to obtain informed consent for surgery\r\n             without a translator)\r\n\r\n         11. Ward of the State children\r\n      ","sponsor":"Washington University School of Medicine","sponsor_type":"Other","conditions":"Systemic Lidocaine Improves Pain Control After Surgery by Attenuating the Systemic Inflammatory Response to Surgery","interventions":[{"intervention_type":"Drug","name":"Drug: IV lidocaine","description":"an amide-type, short-acting local anesthetic and delivered as an aqueous solution for intravenous administration. It has a half-life of 1.5-2 hours. A traditional method of administration is via epidural delivery. Epidural lidocaine is effective and this effect is due, in part, to systemic absorption. Systemic (intravenous) administration of lidocaine is a Food and Drug Administration approved method of delivery. Low plasma levels are needed for effective use, 0.5g/mL to 5.0g/mL. Given this low concentration required and the short half-life, continuous infusion of lidocaine is thought to be generally safe with low risk of complication."},{"intervention_type":"Drug","name":"Drug: Placebos","description":"Saline"}],"outcomes":[{"outcome_type":"primary","measure":"Opioid consumption","time_frame":"up to 6 weeks after surgery","description":"measured in morphine-equivalent dosage (MED)"}]}
{"nct_id":"NCT03993119","start_date":"2019-07-30","enrollment":500,"brief_title":"This Study Observes the Usage of Non-vitamin K Antagonist Oral Anticoagulants (NOACs) in Elderly Patients With a Heart Rhythm Disorder in Spain","official_title":"Non-Interventional, Cross-sectional Study to Describe NOACs Management in Elderly Patients With Non-valvular Atrial Fibrillation (NVAF) in Spain.","primary_completion_date":"2020-08-20","study_type":"Observational","rec_status":"Completed","completion_date":"2020-08-20","last_update":"2021-09-02","description":"This is an observational, multicenter and cross-sectional study in Non-valvular atrial fibrillation (NVAF) elderly patients currently on Non-vitamin K antagonist oral anticoagulant (NOAC) treatment for their stroke prevention.","other_id":"1160-0297","observational_model":"Other","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":75,"population":"Approximately 500 elderly patients with NVAF currently on NOAC treatment are planned to be\r\n        included in the study. To minimize selection bias at the patient level, consecutive\r\n        patients from each site who meet entry criteria will be enrolled. It is planned to have a\r\n        9-month recruitment period from first site initiated, or until the sample size is achieved.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients are willing and provide written informed consent prior to participate in this\r\n             study\r\n\r\n          -  Patients  75 years-old at the time of the study visit.\r\n\r\n          -  Patients with a diagnosis of non-valvular atrial fibrillation (NVAF).\r\n\r\n          -  Patients who are being treated with NOAC treatment according to the indication\r\n             approved in the Summary of Product Characteristics (SmPC).\r\n\r\n          -  Patients who have started the NOAC treatment at least 3 months prior to the study\r\n             visit.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Patients will be excluded from participating in this study if the following criterion is\r\n        met:\r\n\r\n          -  Current participation in any clinical trial of a drug or device.\r\n\r\n          -  Patients who have any contraindication for NOAC treatment, according to the SmPC.\r\n      ","sponsor":"Boehringer Ingelheim","sponsor_type":"Industry","conditions":"Atrial Fibrillation","interventions":[{"intervention_type":"Drug","name":"Drug: Non-vitamin K antagonist oral anticoagulant","description":"Non-vitamin K antagonist oral anticoagulant"}],"outcomes":[{"outcome_type":"primary","measure":"Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Current NOAC Dose According to Sex","time_frame":"At the single study visit (Day 1).","description":"Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to sex is reported."},{"outcome_type":"primary","measure":"Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Sex","time_frame":"At the single study visit (Day 1).","description":"Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to sex is reported."},{"outcome_type":"primary","measure":"Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Age (Categorical)","time_frame":"At the single study visit (Day 1).","description":"Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to patients' age is reported."},{"outcome_type":"primary","measure":"Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Patient's Age (Categorical)","time_frame":"At the single study visit (Day 1).","description":"Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to patient's age (categorical) is reported."},{"outcome_type":"primary","measure":"Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to a Prior Diagnosis of Heart Failure","time_frame":"At the single study visit (Day 1).","description":"Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to a prior diagnosis of heart failure is reported."},{"outcome_type":"primary","measure":"Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to a Prior Diagnosis of Heart Failure","time_frame":"At the single study visit (Day 1).","description":"Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to a prior diagnosis of heart failure is reported."},{"outcome_type":"primary","measure":"Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Coronary Artery Disease","time_frame":"At the single study visit (Day 1).","description":"Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the study visit according to patients' coronary artery disease is reported."},{"outcome_type":"primary","measure":"Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Coronary Artery Disease","time_frame":"At the single study visit (Day 1).","description":"Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to patients' coronary artery disease is reported."},{"outcome_type":"primary","measure":"Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Diabetes","time_frame":"At the single study visit (Day 1).","description":"Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to patients' diabetes is reported."},{"outcome_type":"primary","measure":"Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Diabetes","time_frame":"At the single study visit (Day 1).","description":"Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to patients' diabetes is reported."},{"outcome_type":"primary","measure":"Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Chronic Kidney Disease","time_frame":"At the single study visit (Day 1).","description":"Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to patients' chronic kidney disease is reported."},{"outcome_type":"primary","measure":"Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Chronic Kidney Disease","time_frame":"At the single study visit (Day 1).","description":"Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to patients' chronic kidney disease is reported."},{"outcome_type":"secondary","measure":"Serum Creatinine Concentration From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type","time_frame":"At the single study visit (Day 1).","description":"Serum creatinine concentration from the last available blood sample analysis was retrieved from patients' medical records. Serum creatinine concentration from the last available blood sample analysis according to current NOAC type is reported."},{"outcome_type":"secondary","measure":"Creatinine Clearance From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type","time_frame":"At the single study visit (Day 1).","description":"Results from the last available blood sample analysis from patients' medical records were used to retrieve the creatinine clearance (CrCl). These results were directly collected in the Electronic Case Report Form (eCRF).\r\nIn cases where CrCl was not available in patients's medical record but serum creatinine was available, CrCl was estimated using Cockcroft-Gault formula:\r\nCrCl = (140 - Age(years)) x Weight (kilogram) x [0.85 if female] / 72 x [Serum Creatinine (milligram/deciliterL)]\r\nReported are Crcl values which are calculated according to:\r\nCockcroft-Gault formula and CrCl values directly collected in the eCRF\r\nCockcroft-Gault formula only\r\nDirectly collected in the eCRF"},{"outcome_type":"secondary","measure":"Number of Participants in Each Category of Creatinine Clearance Range From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type","time_frame":"At the single study visit (Day 1).","description":"Results from the last available blood sample analysis from patients' medical records were used to retrieve the creatinine clearance (CrCl). These results were directly collected in the Electronic Case Report Form (eCRF).\r\nIn cases where CrCl was not available in patients' medical record but serum creatinine was available, CrCl was estimated using Cockcroft-Gault formula:\r\nCrCl = (140 - Age(years)) x Weight (kilogram) x [0.85 if female] / 72 x [Serum Creatinine (milligram/deciliterL)]\r\nThe number of participants for each of the following creatinine clearance (CrCl) ranges is reported:\r\nCrCl ≥90: Kidney damage with normal or increased glomerular filtration rate (GFR)\r\nCrCl 60-89: Kidney damage with mild decreased GFR\r\nCrCl 30-59: Moderate decrease in GFR\r\nCrCl 15-29: Severe decrease in GFR\r\nCrCl <15: Kidney failure"},{"outcome_type":"secondary","measure":"Aspartate Aminotransferase (AST) Concentration From the Last Available Blood Sample According to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type","time_frame":"At the single study visit (Day 1).","description":"Results from the last available blood sample analysis from patients' medical records were used to retrieve AST concentration. AST concentration from the last available blood sample according to non-vitamin K antagonist oral anticoagulant (NOAC) type is reported."},{"outcome_type":"secondary","measure":"Alanine Aminotransferase (ALT) From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type","time_frame":"At the single study visit (Day 1).","description":"Results from the last available blood sample analysis from patients's medical records were used to retrieve ALT concentration. ALT concentration from the last available blood sample according to NOAC type is reported."},{"outcome_type":"secondary","measure":"Bilirubin Concentration From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type","time_frame":"At the single study visit (Day 1).","description":"Results from the last available blood sample analysis from patients's medical records were used to retrieve bilirubin concentration. Bilirubin concentration from the last available blood sample according to NOAC type is reported.Results from the last available blood sample analysis from patients' medical records were used to retrieve bilirubin concentration. Bilirubin concentration from the last available blood sample according to NOAC type is reported."},{"outcome_type":"secondary","measure":"Haemoglobin Concentration From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type","time_frame":"At the single study visit (Day 1).","description":"Results from the last available blood sample analysis from patients' medical records were used to retrieve haemoglobin concentration. Haemoglobin concentration from the last available blood sample according to NOAC type is reported."},{"outcome_type":"secondary","measure":"Platelet Levels From the Last Available Blood Sample According to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type","time_frame":"At the single study visit (Day 1).","description":"Results from the last available blood sample analysis from patients's medical records were used to retrieve platelet levels. Platelet levels from the last available blood sample according to NOAC type is reported."},{"outcome_type":"secondary","measure":"Number of Patients in Each Category of Serum Creatinine, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin, Hemoglobin and Platelet Levels According to Current Non-vitamin K Antagonist Oral (NOAC) Type","time_frame":"At the single study visit (Day 1).","description":"Results from the last available blood sample analysis from patients' medical records were used to retrieve serum creatinine, ALT, AST, bilirubin, hemoglobin concentration and platelet levels.\r\nFor each reported laboratory parameter the values were categorized in two categories:\r\nSerum creatinine:\r\nNormal value : 0.6-1.2 mg/dl in males and 0.5-1.1 mg/dl in females\r\nHigh/low value\r\nALT:\r\nNormal values: 7-55 units per liter (UI/L)\r\nHigh/low values\r\nAST:\r\nNormal values: 8-48 UI/L\r\nHigh/low values\r\nBilirubin:\r\nNormal values: 0.2-1.2 milligram per deciliter (mg/dl)\r\nHigh/low values\r\nHaemoglobin:\r\nNormal values: 12-18 gram/deciliter (g/dL)\r\nHigh/low values\r\nPlatelets:\r\nNormal values: 150-450 x10^3/µL\r\nHigh/low values"},{"outcome_type":"secondary","measure":"Non-valvular Atrial Fibrillation (NVAF) Characteristics: Number of Years Since NVAF Diagnosis According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type","time_frame":"At the single study visit (day 1).","description":"The number of years since NVAF diagnosis was obtained from number of years between date of NVAF diagnosis and date of study visit.\r\nThe date of NVAF diagnosis was retrieved from patient's medical records. The number of years since NVAF diagnosis and date of study visit is reported for:\r\nAll patients;\r\nPatients treated previously with vitamin K antagonists (VKA);\r\nPatients treated with NOAC as first anticoagulant ."},{"outcome_type":"secondary","measure":"Non-valvular Atrial Fibrillation (NVAF) Characteristics: Number of Patients in Each Category of NVAF Type According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type","time_frame":"At the single study visit (day 1).","description":"NVAF was categorized in four categories:\r\nPersistent;\r\nLong standing persistent;\r\nPermanent;\r\nParoxysmal."},{"outcome_type":"secondary","measure":"Number of Patients With and Without Any History of Bleeding Events and Number of Patients in Each Category of Bleeding Type According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type","time_frame":"At the single study visit (Day 1).","description":"Number of patients with (category Yes) and without (category No) any history of bleeding events and number of patients in each category of the following bleeding types is reported:\r\nIntracranial\r\nDigestive\r\nGenitourinary\r\nGingival\r\nNasal\r\nPulmonary\r\nArticular-muscular\r\nConjunctival.\r\nIntracranial, digestive, genitourinary, gingival, nasal, pulmonary, articular-muscular, conjunctival were categorized in two categories:\r\nNo\r\nYes."},{"outcome_type":"secondary","measure":"Non-valvular Atrial Fibrillation (NVAF) Characteristics: Number of Patients in Each Category of EHRA Scale for Atrial Fibrillation (AF) Related Symptoms According to Current NOAC Type","time_frame":"At the single study visit (day 1).","description":"The European Heart Rhythm Association (EHRA) score of atrial fibrillation is a classification system for the extent of atrial fibrillation. It places patients in one of five categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina.\r\nThe EHRA categories are the following:\r\n1-no symptoms 2a-mild symptoms; normal daily activity not affected. 2b-moderate symptoms; normal daily activity not affected. 3-severe symptoms; normal daily activity affected. 4-disabling; normal daily activity discontinued."},{"outcome_type":"secondary","measure":"Number of Patients in Each Category of Cardioversion, Ablation, Coronary Interventions and Pacemaker Carrier According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type","time_frame":"At the single study visit (Day 1).","description":"Number of patients with (category Yes) and without (category No) cardioversion, ablation, coronary interventions and pacemaker carrier according to current NOAC type is reported."},{"outcome_type":"secondary","measure":"Number of Patients in Each Category of Coronary Interventions According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type","time_frame":"At the single study visit (Day 1).","description":"Number of patients in each category of coronary interventions according to current non-vitamin K antagonist oral anticoagulant (NOAC) type is reported.\r\nCoronary interventions were categorized in:\r\nPercutaneous coronary intervention and\r\nCoronary artery bypass grafting."},{"outcome_type":"secondary","measure":"Clinical Risk Factors: Number of Patients in Each Category of Heart Failure, Coronary Artery Disease, Sleep Apnoea-hypopnoea Syndrome, Hypertension and Hyperlipidaemia According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type","time_frame":"At the single study visit (Day 1).","description":"Number of patients in each category of heart failure, coronary artery disease, sleep apnoea-hypopnoea syndrome, hypertension and hyperlipidaemia according to current non-vitamin K antagonist oral anticoagulant (NOAC) type is reported.\r\nHeart failure, coronary artery disease, sleep apnoea-hypopnoea syndrome, hypertension and hyperlipidaemia were categorized in the following two categories:\r\nNo;\r\nYes."},{"outcome_type":"secondary","measure":"Clinical Risk Factors: Number of Heart Failure Patients in Each Category of New York Heart Association (NYHA) Classification According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type","time_frame":"At the single study visit (Day 1).","description":"The NYHA provides a simple way of classifying the extent of heart failure and it has 4 categories:\r\nA - No objective evidence of cardiovascular disease\r\nB - Objective evidence of minimal cardiovascular disease\r\nC - Objective evidence of moderately severe cardiovascular disease\r\nD - Objective evidence of severe cardiovascular disease Number of heart failure patients in each category of New York Heart Association (NYHA) classification according to current NOAC type is reported."},{"outcome_type":"secondary","measure":"Clinical Risk Factors: Left Ventricular Ejection Fraction According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type","time_frame":"At the single study visit (Day 1).","description":"Left ventricular ejection fraction (LVEF) according to current non-vitamin K antagonist oral anticoagulant (NOAC) type is reported. LVEF was obtained from the patients' medical records."},{"outcome_type":"secondary","measure":"Age-adjusted Charlson Comorbidity Index Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type","time_frame":"At the single study visit (Day 1).","description":"The Charlson Comorbidity Index is a method of categorizing comorbidities of patients based on the International Classification of Diseases (ICD) diagnosis. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use. Up to 12 comorbidities with various weightings can result in a maximum score of 24. The minimum score is zero."},{"outcome_type":"secondary","measure":"Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type","time_frame":"At the single study visit (Day 1).","description":"Number of patients with (Yes) and without (No) the comorbidities which were included in the Charlson Comorbidity Index according to current NOAC type is reported.\r\nThe comorbidities which were included in the Charlson Comorbidity Index were the following:\r\nMyocardial infarction\r\nCongestive heart failure\r\nPeripheral vascular disease\r\nCerebrovascular disease\r\nDementia\r\nChronic Obstructive Pulmonary Disease (COPD)\r\nConnective tissue disease\r\nPeptic ulcer disease\r\nLiver disease (No/Mild/Moderate to severe)\r\nDiabetes mellitus (No/Uncomplicated/End-organ damage)\r\nHemiplegia\r\nModerate to severe renal disease\r\nSolid Tumor (No/Localized/Metastatic)\r\nLeukaemia\r\nLymphoma\r\nAcquired Immune Deficiency Syndrome (AIDS)."},{"outcome_type":"secondary","measure":"Number of Patients With and Without Any History of Thromboembolic Events, Number of Patients in Each Category of Different Types of Thromboembolic Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type","time_frame":"At the single study visit (Day 1).","description":"Reported is the number of patients in each category of:\r\nAny history of thromboembolic events\r\nTransient Ischemic Attack (TIA)\r\nIschemic stroke\r\nHaemorrhagic stroke\r\nEmbolism systemic\r\nDeep vein thrombosis\r\nPulmonary embolism.\r\nAny history of thromboembolic events, Transient Ischemic Attack (TIA), ischemic stroke, haemorrhagic stroke, embolism systemic, deep vein thrombosis and pulmonary embolism were categorized in the following two categories:\r\nNo\r\nYes."},{"outcome_type":"secondary","measure":"Number of Patients in Each Category of Stable Angina, Unstable Angina, Myocardial Infarction With ST Segment Elevation and Myocardial Infarction Without ST Segment Elevation According to Current NOAC Type","time_frame":"At the single study visit (Day 1).","description":"Number of patients in each category of stable angina, unstable angina, myocardial infarction with ST segment elevation and myocardial infarction without ST segment elevation according to current non-vitamin K antagonist oral anticoagulant (NOAC) type is reported.\r\nStable angina, unstable angina, myocardial infarction with ST segment elevation myocardial infarction without ST segment elevation were categorized in the following 2 categories:\r\nYes;\r\nNo."},{"outcome_type":"secondary","measure":"Total Number of Thromboembolic Events, Number of Each Type of Thromboembolic Events, Number of Stable and Unstable Anginas, and Number of ST and Non-ST Myocardial Infarction According to Current NOAC Type","time_frame":"At the single study visit (Day 1).","description":"Total number of thromboembolic events, number of each type of thromboembolic events, number of stable and unstable anginas, and number of ST and non-ST myocardial infarction according to current non-vitamin K antagonist oral anticoagulant (NOAC) type is reported."},{"outcome_type":"secondary","measure":"Total Number of Bleeding Events and Number of Each Type of Bleeding Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type","time_frame":"At the single study visit (Day 1).","description":"Total number of bleeding events and number of bleeding events for the following bleeding types is reported:\r\nIntracranial\r\nDigestive\r\nGenitourinary\r\nGingival\r\nNasal\r\nPulmonary\r\nArticular-muscular\r\nConjunctival."},{"outcome_type":"secondary","measure":"CHA2DS2-VASc Total Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type","time_frame":"At the single study visit (Day 1).","description":"The Congestive heart failure, Hypertension, Age (> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc) score is a clinical prediction rule to estimate the risk of stroke in patients with Atrial Fibrillation (AF); it is frequently used to determine the need for an anticoagulation therapy, relating the high scores to a great risk of stroke and a low score corresponds to a lower risk of stroke. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome."},{"outcome_type":"secondary","measure":"Number of Patients on Each Category of CHA2DS2-VASc Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type","time_frame":"At the single study visit (Day 1).","description":"The Congestive heart failure, Hypertension, Age (> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc) total score was categorized in three categories, according to the risk of stroke:\r\nLow risk (score 0 in male; score 1 in female)\r\nModerate risk (score 1 in male; score 2 in female)\r\nHigh risk (score ≥2 in male; score ≥3 in female)"},{"outcome_type":"secondary","measure":"HAS-BLED Total Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type","time_frame":"At the single study visit (Day 1).","description":"Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile International Normalized Ratio (INR), Elderly (>65 years), Drugs and Alcohol (HAS-BLED) score may range from 0 to 9 with 0 being the best outcome. The high scores indicate a greater risk of bleeding and a low score corresponds to a lower risk of bleeding."},{"outcome_type":"secondary","measure":"Number of Patients in Each Category of HAS-BLED Score According to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type","time_frame":"At the single study visit (Day 1).","description":"The Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs and Alcohol (HAS-BLED) total score was categorized in three categories according to the bleeding risk:\r\nLow risk (score 0)\r\nIntermediate risk (score 1-2)\r\nHigh risk (score ≥3)"},{"outcome_type":"secondary","measure":"Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type","time_frame":"At the single study visit (Day 1).","description":"Number of patients in each category (No;Yes) of any concomitant treatments to NOAC and number of patients in each category (No; Yes) for each concomitant treatment to NOAC at study visit according to current NOAC type is reported.\r\nThe concomitant treatment to non-vitamin K antagonist oral anticoagulant (NOAC) were the following:\r\nAngiotensin-Receptor Blockers (ARB) or Angiotensin Converting Enzyme inhibitors (ACE) inhibitor\r\nBeta-blocker\r\nCalcium channel blockers\r\nDiuretics\r\nAmiodarone\r\nStatin\r\nProton pump inhibitor\r\nH2-receptor antagonist\r\nDigoxin\r\nNSAIDs (Nonsteroidal Anti-Inflammatory Drugs)\r\nDronedarone\r\nKetoconazole\r\nCyclosporine\r\nItraconazole\r\nOther antiarrhythmics"},{"outcome_type":"secondary","measure":"Number of Patients in Each Category of Previous Vitamin K Antagonists (VKA) Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation","time_frame":"At the single study visit (Day 1).","description":"Number of patients in each category of previous Vitamin K Antagonists (VKA) treatment according to duration since the first non-vitamin K antagonist oral anticoagulant (NOAC) initiation is reported.\r\nPrevious VKA treatment was categorized in 2 categories:\r\nNo;\r\nYes."},{"outcome_type":"secondary","measure":"Number of Patients Treated Previously With the VKA Acenocoumarol and Number of Patients Treated Previously With the VKA Warfarin According to Duration Since the First NOAC Initiation","time_frame":"At the single study visit (Day 1).","description":"Number of patients treated previously (before they were treated with non-vitamin K antagonist oral anticoagulant (NOAC)) with the Vitamin K Antagonists (VKA) acenocoumarol and number of patients treated previously with the VKA warfarin according to duration since the first NOAC initiation is reported."},{"outcome_type":"secondary","measure":"Duration of Previous Vitamin K Antagonists (VKA) Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation","time_frame":"At the single study visit (Day 1).","description":"Duration of treatment (in years) is reported for:\r\nAll patients treated previously with Vitamin K Antagonists (VKA) (row:All patients treated previously with VKA)\r\nPatients treated only with the VKA warfarin (row: Warfarin patients)\r\nPatients treated only with the VKA acenocoumarol (row: Acenocoumarol patients)"},{"outcome_type":"secondary","measure":"Duration Since Non-valvular Atrial Fibrillation (NVAF) Diagnosis Until First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation According to Duration Since the First NOAC Initiation","time_frame":"At the single study visit (Day 1).","description":"Duration (in years) since non-valvular atrial fibrillation (NVAF) diagnosis until first NOAC initiation according to duration since the first NOAC initiation is reported for:\r\nAll patients\r\nPatients treated previously with VKA\r\nPatients treated only with NOAC as anticoagulant (AC)"},{"outcome_type":"secondary","measure":"First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and First NOAC Dose According to Duration Since the First NOAC Initiation","time_frame":"At the single study visit (Day 1).","description":"Number of patients who received dabigatran, rivaroxaban, apixaban, edoxaban as first NOAC and number of patients who received dabigatran 110 mg BID (twice daily), dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD as first NOAC according to duration since the first NOAC initiation is reported."},{"outcome_type":"secondary","measure":"Number of Patients Who Changed (Increased and Decreased) and Did Not Change the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Dose According to Duration Since the First NOAC Initiation","time_frame":"At the single study visit (Day 1).","description":"Number of patients who changed (increased and decreased) and did not change the first non-vitamin K antagonist oral anticoagulant (NOAC) dose according to duration since the first NOAC initiation is reported."},{"outcome_type":"secondary","measure":"First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Duration (in Years) According to Duration Since the First NOAC Initiation","time_frame":"At the single study visit (Day 1).","description":"Treatment duration (in years) is reported for:\r\nPatients who stopped first NOAC treatment;\r\nPatients who did not stop the first NOAC treatment."},{"outcome_type":"secondary","measure":"Number of Patients in Each Category of Reason for First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Discontinuation According to Duration Since the First NOAC Initiation","time_frame":"At the single study visit (Day 1).","description":"Reason for first NOAC treatment discontinuation was categorized in four categories:\r\nLack of effectiveness\r\nInvestigator's decision\r\nPatient's decision\r\nAdverse event"},{"outcome_type":"secondary","measure":"Number of Patients in Each Category of Reason for First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Change Dose According to Duration Since the First NOAC Initiation","time_frame":"At the single study visit (Day 1).","description":"Reason for first NOAC treatment change was categorized in four categories:\r\nLack of effectiveness\r\nInvestigator's decision\r\nPatient's decision\r\nAdverse event"},{"outcome_type":"secondary","measure":"Number of Switches to a New Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Per Patient According to Duration Since the First NOAC Initiation","time_frame":"At the single study visit (Day 1).","description":"Number of switches to a new non-vitamin K antagonist oral anticoagulant (NOAC) per patient according to duration since the first NOAC initiation is reported."},{"outcome_type":"secondary","measure":"Number of Patients in Each Category of Number of Switches to a New Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Per Patient According to Duration Since the First NOAC Initiation","time_frame":"At the single study visit (Day 1).","description":"Number of patients based on the number of switches to a new NOAC per patient according to duration since the first NOAC initiation is reported.\r\nNumber of switches to a new NOAC was categorized in 3 categories:\r\n0 switches\r\n1 switch\r\n2 switches."},{"outcome_type":"secondary","measure":"Total Number of Switches According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation","time_frame":"At the single study visit (Day 1).","description":"Total number of switches according to duration since the first NOAC initiation is reported."},{"outcome_type":"secondary","measure":"Number of Switches in Each Category of Reason for Switch According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation","time_frame":"At the single study visit (Day 1).","description":"Reason for switch was categorized in four categories:\r\nLack of effectiveness\r\nInvestigator's decision\r\nPatient's decision\r\nAdverse event"},{"outcome_type":"secondary","measure":"Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Second NOAC Dose According to Duration Since the First NOAC Initiation","time_frame":"At the single study visit (Day 1).","description":"Number of patients who received dabigatran, rivaroxaban, apixaban, edoxaban as second NOAC and number of patients who received dabigatran 110 mg BID (twice daily), dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD as second NOAC according to duration since the first NOAC initiation is reported."},{"outcome_type":"secondary","measure":"Number of Patients Who Changed (Increased or Decreased) and Did Not Change the Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Dose According to Duration Since the First NOAC Initiation","time_frame":"At the single study visit (Day 1).","description":"Number of patients who changed (increased or decreased) and did not change the second non-vitamin K antagonist oral anticoagulant (NOAC) dose according to duration since the first NOAC initiation is reported."},{"outcome_type":"secondary","measure":"Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Duration (in Years) According to Duration Since the First NOAC Initiation","time_frame":"At the single study visit (Day 1).","description":"Second NOAC treatment duration (in years) according to duration since the first NOAC initiation is reported."},{"outcome_type":"secondary","measure":"Number of Patients in Each Category of Reason for Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Discontinuation According to Duration Since the First NOAC Initiation","time_frame":"At the single study visit (Day 1).","description":"Reason for second non-vitamin K antagonist oral anticoagulant (NOAC) treatment discontinuation was categorized in four categories:\r\nLack of effectiveness\r\nInvestigator's decision\r\nPatient's decision\r\nAdverse event"},{"outcome_type":"secondary","measure":"Number of Patients in Each Category of Reason for Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Change Dose According to Duration Since the First NOAC Initiation","time_frame":"At the single study visit (Day 1).","description":"Reason for second NOAC treatment change was categorized in four categories:\r\nLack of effectiveness\r\nInvestigator's decision\r\nPatient's decision\r\nAdverse event"},{"outcome_type":"secondary","measure":"Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Third NOAC Dose According to Duration Since the First NOAC Initiation","time_frame":"At the single study visit (Day 1).","description":"Number of patients who received dabigatran, rivaroxaban, apixaban, edoxaban as third NOAC and number of patients who received dabigatran 110 mg BID (twice daily), dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD as third NOAC according to duration since the first NOAC initiation is reported."},{"outcome_type":"secondary","measure":"Number of Patients Who Changed (Increased and Decreased) and Did Not Change the Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Dose According to Duration Since the First NOAC Initiation","time_frame":"At the single study visit (Day 1).","description":"Number of patients who changed (increased and decreased) and did not change the third non-vitamin K antagonist oral anticoagulant (NOAC) dose according to duration since the first NOAC initiation is reported."},{"outcome_type":"secondary","measure":"Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Duration (in Years) According to Duration Since the First NOAC Initiation","time_frame":"At the single study visit (Day 1).","description":"Duration of third NOAC treatment for patients who stopped NOAC treatment."},{"outcome_type":"secondary","measure":"Number of Patients in Each Category of Reason for Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Discontinuation According to Duration Since the First NOAC Initiation","time_frame":"At the single study visit (Day 1).","description":"Reason for Third NOAC treatment discontinuation was categorized in four categories:\r\nLack of effectiveness\r\nInvestigator's decision\r\nPatient's decision\r\nAdverse event"},{"outcome_type":"secondary","measure":"Number of Patients in Each Category of Reason for Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Change Dose According to Duration Since the First NOAC Initiation","time_frame":"At the single study visit (Day 1).","description":"Reason for Third NOAC treatment change was categorized in four categories:\r\nLack of effectiveness\r\nInvestigator's decision\r\nPatient's decision\r\nAdverse event"},{"outcome_type":"secondary","measure":"Duration (in Years) in Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment According to Duration Since the First NOAC Initiation","time_frame":"At the single study visit (Day 1).","description":"Duration (in years) in NOAC treatment is reported for:\r\nAll patients (patients who received or did not receive VKA)\r\nPatients treated previously with Vitamin K Antagonists (VKA)\r\nPatients treated with NOAC as first anticoagulant"},{"outcome_type":"secondary","measure":"Number of Patients in Each Category of Total Time in Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment According to Duration Since the First NOAC Initiation","time_frame":"At the single study visit (Day 1).","description":"Number of patients in each category of total time in non-vitamin K antagonist oral anticoagulant (NOAC) treatment according to duration since the first NOAC initiation is reported.\r\nTotal time in NOAC treatment was categorized in 4 categories:\r\n<1 year;\r\n1-2 years;\r\n2-3 years;\r\n>3 years."},{"outcome_type":"secondary","measure":"Number of Patients for Each Type of Antiplatelet Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation","time_frame":"At the single study visit (Day 1).","description":"Number of patients for each type of following antiplatelet treatment that the patients ever received is reported:\r\nNone (reports the patients who did not receive any antiplatelet treatment)\r\nAcetyl salicylic acid\r\nClopidogrel\r\nPrasugrel\r\nTiclopidine\r\nTicagrelor\r\nCilostazol\r\nTriflusal\r\nDipyridamole\r\nOthers (other antiplatelet treatment than above mentioned)."},{"outcome_type":"secondary","measure":"Number of Patients for Each Type of Antiplatelet Treatment at the Time of Study Visit According to Duration Since the First NOAC Initiation","time_frame":"At the single study visit (Day 1).","description":"Number of patients for each of the following antiplatelet treatment types at the time of study visit according to duration since the first NOAC initiation is reported:\r\nNone (reports the patients who did not receive any antiplatelet treatment)\r\nAcetyl salicylic acid\r\nClopidogrel\r\nPrasugrel\r\nTiclopidine\r\nTicagrelor\r\nCilostazol\r\nTriflusal\r\nDipyridamole\r\nOthers (other antiplatelet treatment than above mentioned)."},{"outcome_type":"secondary","measure":"Time in Treatment With Antiplatelet Agents (in Years) According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation","time_frame":"At the single study visit (Day 1).","description":"Time in treatment with antiplatelet agents (in years) according to duration since the first NOAC initiation is reported."},{"outcome_type":"secondary","measure":"Number of Patients in Each Score of Clinical Frailty Scale Grading at the Time of the Study Visit According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type","time_frame":"At the single study visit (Day 1).","description":"Clinical Frailty Scale (CFS) is used commonly to assess frailty. It is a 9-point scale from 1 to 9 (1=very fit; 2=well; 3=Managing well; 4=Vulnerable; 5=Mildly frail; 6=Moderately frail; 7=Severely frail; 8=very severely frail; 9=terminally ill) that summarizes the overall level of fitness or frailty of an older adult after they had been evaluated by a health care professional. Applying the CFS to patients is quick and requires data collection by watching the patient (mobilize), inquiring about their habitual physical activity and ability. A person with a score >4 was considered frail."},{"outcome_type":"secondary","measure":"Number of Patients in Each Category Clinical Frailty Scale at the Time of the Study Visit According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type","time_frame":"At the single study visit (Day 1).","description":"Clinical Frailty Scale (CFS) is used commonly to assess frailty. It is a 9-point scale from 1 to 9 (1=very fit; 2=well; 3=Managing well; 4=Vulnerable; 5=Mildly frail; 6=Moderately frail; 7=Severely frail; 8=very severely frail; 9=terminally ill) that summarizes the overall level of fitness or frailty of an older adult after they had been evaluated by a health care professional. Applying the CFS to patients is quick and requires data collection by watching the patient (mobilize), inquiring about their habitual physical activity and ability.\r\nCFS was categorized in two categories, according to this ranges:\r\nFrailty patients - CFS scoring >4\r\nNon-frailty patients - CFS scoring ≤4"},{"outcome_type":"secondary","measure":"Number of Patients in Each Category of Reason for First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Usage at the Time of First NOAC Initiation According to Current NOAC Type","time_frame":"At the single study visit (Day 1).","description":"Reason for First NOAC usage was categorized in the following two categories:\r\nPrimary prevention;\r\nSecondary prevention."}]}
{"nct_id":"NCT03948880","start_date":"2019-07-29","enrollment":101,"brief_title":"Incidence OIRD Medical and Trauma Patients","official_title":"Incidence of OIRD in Medical and Trauma Patients on the General Care Floor Receiving PCA or Nurse Administered Intravenous Opioids Monitored by Capnography and Pulse Oximetry: A Prospective, Blinded Observational Study","primary_completion_date":"2019-10-29","study_type":"Observational","rec_status":"Unknown status","completion_date":"2019-11-29","last_update":"2019-07-31","description":"The primary objective of this prospective, blinded observational study is to correlate assessment of sedation and respiratory status with capnography and pulse oximetry monitoring in hospitalized adult medical and trauma patients receiving patient-controlled analgesia (PCA) or nurse administered intravenous opioids for acute pain. Nursing assessment of respiratory status and sedation level will be correlated with capnography and pulse oximetry values as technology-supported monitoring to identify respiratory depression and opioid-induced sedation. The secondary objective is to identify capnography and pulse oximetry values that correlate with respiratory decompensation and opioid-induced sedation in medical and trauma patients on the general care floor.","other_id":"FresnoCHMC","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":89,"population":"The target study population will be hospitalized, adult medical or trauma patients on the\r\n        general care floor receiving patient-controlled analgesia or nurse administered intravenous\r\n        opioids for acute pain.","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Spontaneously breathing adults 18 to 89 years of age\r\n\r\n          2. Receiving PCA or nurse administered IV opioids for medical or trauma-related pain\r\n\r\n          3. Admitted to the general care floor from the emergency department\r\n\r\n          4. Able to provide written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Age is less than 18 years or greater than 89 years\r\n\r\n          2. Transfer to the general care floor from the ICU\r\n\r\n          3. Provider order for respiratory monitoring using continuous capnography\r\n\r\n          4. Receiving intrathecal or epidural opioids\r\n\r\n          5. Trauma patient with a nerve block\r\n\r\n          6. Inability or unwillingness to wear the EtCO2 sampling line nasal cannula or pulse\r\n             oximetry sensor\r\n\r\n          7. History or diagnosis of a sleep disordered breathing syndrome\r\n\r\n          8. Use of CPAP or BIPAP non-invasive ventilation as home regime\r\n\r\n          9. Pre-existing co-morbidity that impacts respiration or ventilation (e.g. COPD or\r\n             pulmonary fibrosis) (for the purpose of this study a trauma patient with rib fractures\r\n             is not considered having a pre-existing condition)\r\n\r\n         10. Receiving non-invasive ventilation\r\n\r\n         11. Unable or unwilling to participate\r\n\r\n         12. Member of a vulnerable population such as pregnant women or prisoners\r\n      ","sponsor":"Fresno Community Hospital and Medical Center","sponsor_type":"Other","conditions":"Respiratory Depression|Sedation","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Hypoventilation","time_frame":"Change from baseline measurement observed within 60 minutes after opioid administration","description":"The number of subjects who experience hypoventilation using respiratory monitoring with continuous capnography for data collection."},{"outcome_type":"primary","measure":"Hypoventilation","time_frame":"Change from baseline measurement observed within 60 minutes after opioid administration","description":"The percentage of subjects who experience hypoventilation using respiratory monitoring with continuous capnography for data collection."},{"outcome_type":"primary","measure":"Hypoventilation","time_frame":"Change from baseline measurement observed within 60 minutes after opioid administration","description":"The characteristics of subjects who experience hypoventilation using respiratory monitoring with continuous capnography for data collection."},{"outcome_type":"secondary","measure":"Hypoxemia","time_frame":"Change from baseline measurement observed within 60 minutes after opioid administration ]","description":"The number of subjects who experience oxygen desaturation using respiratory monitoring with continuous pulse oximetry for data collection."},{"outcome_type":"secondary","measure":"Hypoxemia","time_frame":"Change from baseline measurement observed within 60 minutes after opioid administration ]","description":"The percentage of subjects who experience oxygen desaturation using respiratory monitoring with continuous pulse oximetry for data collection."},{"outcome_type":"secondary","measure":"Hypoxemia","time_frame":"Change from baseline measurement observed within 60 minutes after opioid administration ]","description":"The characteristics of subjects who experience oxygen desaturation using respiratory monitoring with continuous pulse oximetry for data collection."},{"outcome_type":"other","measure":"Sedation","time_frame":"Change from baseline assessment observed within 60 minutes after opioid administration ]","description":"The number of subjects who experience unintended sedation using the Pasero Opioid-Induced Sedation Scale in which sedation levels of S, 1, 2, 3, 4 are assessed where \"S\" represents normal sleep, increasing numbers represent increasing levels of sedation, and sedation levels 3 or 4 indicate unintended opioid-induced sedation for the purpose of this study"},{"outcome_type":"other","measure":"Sedation","time_frame":"Change from baseline assessment observed within 60 minutes after opioid administration ]","description":"The percentage of subjects who experience unintended sedation using the Pasero Opioid-Induced Sedation Scale in which sedation levels of S, 1, 2, 3, 4 are assessed where \"S\" represents normal sleep, increasing numbers represent increasing levels of sedation, and sedation levels 3 or 4 indicate unintended opioid-induced sedation for the purpose of this study"},{"outcome_type":"other","measure":"Sedation","time_frame":"Change from baseline assessment observed within 60 minutes after opioid administration ]","description":"The characteristics of subjects who experience unintended sedation using the Pasero Opioid-Induced Sedation Scale in which sedation levels of S, 1, 2, 3, 4 are assessed where \"S\" represents normal sleep, increasing numbers represent increasing levels of sedation, and sedation levels 3 or 4 indicate unintended opioid-induced sedation for the purpose of this study"},{"outcome_type":"other","measure":"Sedation","time_frame":"Change from baseline assessment observed within 60 minutes after opioid administration","description":"The number of subjects who experience unintended sedation using the Moline Roberts Pharmacologic Sedation Scale in which sedation levels of 1, 2, 3, 4, 5, 6 are assessed where increasing numbers represent increasing levels of sedation and sedation levels 3 or 4 or 5 or 6 indicate unintended opioid-induced sedation for the purpose of this study"},{"outcome_type":"other","measure":"Sedation","time_frame":"Change from baseline assessment observed within 60 minutes after opioid administration","description":"The percentage of subjects who experience unintended sedation using the Moline Roberts Pharmacologic Sedation Scale in which sedation levels of 1, 2, 3, 4, 5, 6 are assessed where increasing numbers represent increasing levels of sedation and sedation levels 3 or 4 or 5 or 6 indicate unintended opioid-induced sedation for the purpose of this study"},{"outcome_type":"other","measure":"Sedation","time_frame":"Change from baseline assessment observed within 60 minutes after opioid administration","description":"The characteristics of subjects who experience unintended sedation using the Moline Roberts Pharmacologic Sedation Scale in which sedation levels of 1, 2, 3, 4, 5, 6 are assessed where increasing numbers represent increasing levels of sedation and sedation levels 3 or 4 or 5 or 6 indicate unintended opioid-induced sedation for the purpose of this study"},{"outcome_type":"other","measure":"Sedation","time_frame":"Change from baseline assessment observed within 60 minutes after opioid administration","description":"The number of subjects who experience unintended sedation using the Richmond Agitation Sedation Scale in which sedation levels of +4, +3, +2, +1, 0, -1, -2, -3, -4, -6 are assessed where decreasing numbers represent increasing levels of sedation and sedation levels of -1 or -2 or -3 or -4 or -5 indicate unintended opioid-induced sedation for the purpose of this study"},{"outcome_type":"other","measure":"Sedation","time_frame":"Change from baseline assessment observed within 60 minutes after opioid administration","description":"The percentage of subjects who experience unintended sedation using the Richmond Agitation Sedation Scale in which sedation levels of +4, +3, +2, +1, 0, -1, -2, -3, -4, -6 are assessed where decreasing numbers represent increasing levels of sedation and sedation levels of -1 or -2 or -3 or -4 or -5 indicate unintended opioid-induced sedation for the purpose of this study"},{"outcome_type":"other","measure":"Sedation","time_frame":"Change from baseline assessment observed within 60 minutes after opioid administration","description":"The characteristics of subjects who experience unintended sedation using the Richmond Agitation Sedation Scale in which sedation levels of +4, +3, +2, +1, 0, -1, -2, -3, -4, -6 are assessed where decreasing numbers represent increasing levels of sedation and sedation levels of -1 or -2 or -3 or -4 or -5 indicate unintended opioid-induced sedation for the purpose of this study"}]}
{"nct_id":"NCT03727334","start_date":"2019-07-25","phase":"N/A","enrollment":25,"brief_title":"Offsetting Hippocampal Degeneration in m-sTBI","official_title":"Offsetting Hippocampal Degeneration in Moderate to Severe TBI","primary_completion_date":"2020-07-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2020-07-31","last_update":"2019-09-03","description":"The goal of this study is to establish the feasibility of an intervention designed to improve memory in patients who have experienced a moderate or severe traumatic brain injury (m-sTBI) and to examine its effect on brain structures.","other_id":"H17-03544","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","intervention_model_description":"This is a randomized two-armed study, comprised of a treatment arm and a control arm. Given the small numbers and the potentially slow rate of recruitment, the investigators will employ simple rather than block randomization. To minimize selection bias, allocation to group will be concealed (i.e., with assignment unpredictable and unchangeable) using software that randomizes each patient upon confirmation of eligibility. Patients will not be blind to group assignment, but the psychometrist completing behavioural outcomes will be kept blind to group assignment.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  An acute care diagnosis of TBI as indicated by\r\n\r\n               -  Post-traumatic amnesia duration of 24 hours or more, and/or lowest Glasgow Coma\r\n                  Scale score of < 13\r\n\r\n               -  Positive clinical CT or MRI scan\r\n\r\n          -  Aged 18 to 65\r\n\r\n          -  Fluent in English\r\n\r\n          -  Have the competency for fully informed consent by 6 months post-injury\r\n\r\n          -  Have basic computer skills\r\n\r\n          -  Have functional use of one upper extremity\r\n\r\n          -  Have access to the internet\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  A neurological disorder other than TBI (e.g., stroke, dementia, tumor,\r\n             neurodevelopmental disorder) impairing baseline awareness, cognition, or validity of\r\n             follow-up and outcome assessment.\r\n\r\n          -  A systemic condition (e.g., lupus, diabetes, rheumatoid arthritis).\r\n\r\n          -  Any contraindications to magnetic resonance imaging (MRI)\r\n\r\n          -  A diagnosed learning disability or learning problems (e.g., dyslexia, language\r\n             processing disorder, non-verbal learning disabilities, perceptual/motor deficits,\r\n             attention deficit disorders etc.)\r\n      ","sponsor":"University of British Columbia","sponsor_type":"Other","conditions":"Traumatic Brain Injury|Degeneration|Memory; Loss, Mild, Following Organic Brain Damage","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Online Spatial Navigation Training","description":"Participants complete training tasks that test their spatial navigational abilities, cognitive map formation, and pattern separation. These training tasks involve map drawing, vector mapping, proximity judgments, and navigating with blocked routes."}],"outcomes":[{"outcome_type":"primary","measure":"Online Spatial Navigation Intervention Test Scores: Change in Spatial Learning Ability","time_frame":"Time-point 1: 6 months post-injury and Time-point 2: 10 months post-injury","description":"Participants complete online spatial navigation training 5 days per week for 16 weeks. Improvement in spatial learning ability will be assessed based on the accuracy of answers to questions regarding the reproduction of spatial elements, the direction and proximity of certain landmarks, and describing the most efficient route from point A to point B. Improvement will be assessed at the end of each week and at the end of the intervention. The raw scores range from 0-15, with higher scores indicating better spatial learning ability."},{"outcome_type":"primary","measure":"Online Spatial Navigation Intervention Test Scores: Change in Cognitive Map Formation","time_frame":"Time-point 1: 6 months post-injury and Time-point 2: 10 months post-injury","description":"Participants complete online spatial navigation training 5 days per week for 16 weeks. Improvement in cognitive map formation will be assessed based on the number of trails required by the participant to learn landmark placements and based on the accuracy of the participant's navigation to a specific destination. The raw scores range from 1-21 and 0-10, respectively. A decrease in the number of trials required by the participant and an increase in navigation accuracy both correspond to an improvement in cognitive map formation."},{"outcome_type":"primary","measure":"Online Spatial Navigation Intervention Test Scores: Change in Pattern Separation","time_frame":"Time-point 1: 6 months post-injury and Time-point 2: 10 months post-injury","description":"Measurement of pattern separation abilities are assessed in a task requiring the participant to differentiate memories in order to prevent interference from overlapping details. The following three variables are taken into account: i) percent correct ii) the discriminating value and iii) bias metric. Percent correct and bias metric are given as a percentage values (e.g., 80.63%) and the discriminating variable is given as a raw rate (e.g., 0.67). An improvement in pattern separation abilities are determined by an increase in percent correct and discrimination values from pre- to post-intervention. An increase in bias metric from pre- to post-intervention reflects an increased tendency for pattern separation."},{"outcome_type":"primary","measure":"Online Spatial Navigation Intervention Test Scores: Change in Pattern Completion","time_frame":"Time-point 1: 6 months post-injury and Time-point 2: 10 months post-injury","description":"Measurement of pattern completion abilities are assessed in a task designed to probe pattern completion by presenting partial retrieval cues at different levels of degradation. The following variables are taken into account: i) accuracy for learned stimuli given as a percentage value (i.e., correctly selecting the name of the scene) ii) accuracy for new stimuli given as a percentage value (i.e., correctly indicating the stimuli is novel) and iii) bias measure. The bias measure is obtained by subtracting the learned stimuli accuracy score from the new stimuli accuracy score. An increase for both accuracy measures from pre- to post-intervention corresponds to improvement on recognition memory. An increase in bias measure reflects an increased tendency for pattern separation."},{"outcome_type":"secondary","measure":"Neuronal injury biomarker predictors in serum and plasma samples","time_frame":"Time-point 1: 6 months post-injury and Time-point 2: 12 months post-injury","description":"The investigators will be analysing biomarkers in serum and plasma samples in relation to traumatic brain injuries. This will allow the investigators to generate hypotheses concerning the relationship between blood biomarkers and neuronal injury. Serum neurofilament light chains (NF-L), total tau, amyloid β-40 and amyloid β-42 will be assayed using Quanterix reagents on the Simoa HD-1 platform."},{"outcome_type":"secondary","measure":"Gliosis and inflammation biomarker predictors in serum samples","time_frame":"Time-point 1: 6 months post-injury and Time-point 2: 12 months post-injury","description":"The investigators will be analysing biomarkers in serum samples in relation to gliosis and inflammation. This will allow the investigators to generate hypotheses concerning the relationship between blood biomarkers and neuroimmune response. Serum monocyte chemoattractant protein-1 (MCP-1) will be assayed using MesoScale Discovery reagents on the Sector S600 platform and glial fibrillary acidic protein (GFAP) will be assayed using Quanterix reagents on the Simoa HD-1 platform."}]}
{"nct_id":"NCT03957876","start_date":"2019-07-25","phase":"Phase 2","enrollment":25,"brief_title":"CPX-351 Therapy for MDS After Hypomethylating Agent Failure","official_title":"A Phase II Study of CPX-351 as a Novel Therapeutic Approach for Patients With Myelodysplastic Syndromes (MDS) After Hypomethylating Agent Failure","primary_completion_date":"2022-02-28","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-02-28","last_update":"2021-04-22","description":"The purpose of this study is to evaluate the efficacy of treatment with CPX-351 (an FDA approved drug for the treatment of AML) in individuals with MDS while using a new stratification tool to predict outcomes of participants following HMA failure. This approach is intended to gain a better understanding and insight into identifying new opportunities for drug approvals in this setting.","other_id":"CASE2918","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients must give voluntary written consent before performance of any study related\r\n             procedures not part of standard medical care\r\n\r\n          -  Diagnosis of MDS or MDS/MPN according to 2016 WHO criteria12\r\n\r\n          -  Primary therapy failure with either hypomethylating agents (decitabine or azacitidine)\r\n             defined as:\r\n\r\n          -  Progression (according to 2006 IWG criteria)13 after initiation of azacitidine or\r\n             decitabine treatment; or\r\n\r\n          -  Failure to achieve complete or partial response or hematological improvement\r\n             (according to 2006 IWG)13 after at least 4-6 cycles (4-weeks cycle) of azacitidine or\r\n             decitabine; or\r\n\r\n          -  Relapse after initial complete or partial response or hematological improvement\r\n             (according to 2006 IWG criteria)13 observed after at least 4 cycles of azacitidine or\r\n             decitabine.\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) Performance Status < 2\r\n\r\n          -  Subjects must have normal organ and marrow function defined as:\r\n\r\n          -  If total bilirubin < 2x upper limit of normal (<\/= 3 x ULN if considered to be due to\r\n             leukemic involvement or Gilbert's syndrome) at the discretion of the treating\r\n             physician following discussion with PI)\r\n\r\n          -  Calculated creatinine clearance value of > 30ml/min AND a serum creatinine < 1.5mg/dL\r\n\r\n          -  LVEF >/= 50%\r\n\r\n          -  Female patients who:\r\n\r\n          -  Are postmenopausal for at least 1 year before the screening visit, OR\r\n\r\n          -  Are surgically sterile, OR\r\n\r\n          -  Agree to practice true abstinence from heterosexual contact or agree to use effective\r\n             contraception without interruption during the study therapy and 90 days after the last\r\n             dose\r\n\r\n          -  Male patients who:\r\n\r\n          -  Are surgically sterile, OR\r\n\r\n          -  Agree to practice true abstinence from heterosexual contact or agree to use effective\r\n             contraception without interruption during the study therapy and 90 days after the last\r\n             dose\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior treatment with CPX-351, or known hypersensitivity to CPX-351 or its components.\r\n\r\n          -  Prior treatment with intensive chemotherapy.\r\n\r\n          -  Any serious medical condition, laboratory abnormality, or psychiatric illness that, in\r\n             the view of the treating physician, would place the participant at an unacceptable\r\n             risk if he or she were to participate in the study or would prevent that person from\r\n             giving informed consent.\r\n\r\n          -  Any active malignancy (unrelated, non-hematological malignancy) diagnosed within the\r\n             past 6 months of starting the study drug (other than curatively treated\r\n             carcinoma-in-situ of the cervix or non-melanoma skin cancer).\r\n\r\n          -  Patients with uncontrolled intercurrent illness including, but not limited to ongoing\r\n             or active infection, symptomatic congestive heart failure, unstable angina pectoris,\r\n             cardiac arrhythmia, or psychiatric illness/social situations that would limit\r\n             compliance with study requirements.\r\n\r\n          -  Known history of HIV or active hepatitis B or C.\r\n\r\n          -  Major surgery within 2 weeks prior to study enrollment.\r\n\r\n          -  Pregnant or lactating females\r\n\r\n          -  Male and female patients who are fertile who do not agree to use an effective barrier\r\n             methods of birth control (i.e. abstinence or 2 forms of contraception) to avoid\r\n             pregnancy while receiving study treatment.\r\n      ","sponsor":"Case Comprehensive Cancer Center","sponsor_type":"Other","conditions":"Myelodysplastic Syndrome (MDS)","interventions":[{"intervention_type":"Drug","name":"Drug: CPX-351","description":"CPX-351 is a liposomal formulation of a fixed combination of the antineoplastic drugs cytarabine and daunorubicin."}],"outcomes":[{"outcome_type":"primary","measure":"Efficacy of CPX-351 as measured by overall response rate (ORR)","time_frame":"day 28 +/- 7 days of induction","description":"Efficacy of CPX as measured by ORR as defined by IWG 2006 criteria for MDS participants at end of induction."},{"outcome_type":"secondary","measure":"Time to response (TTR) associated with CPX-351","time_frame":"day 28 +/- 7 days of induction","description":"TTR associated with CPX-351 in participant with MDS at the end of induction. TTR defined by the time between starting the treatment and the time of achieving best response."},{"outcome_type":"secondary","measure":"Duration of response (DOR) in participants achieving a response","time_frame":"At the end of cycle 1 (each cycle is 28 days), up to 1 year after end of treatment","description":"DOR in participants achieving a response defined by the time between first response (day C1 D28 +/-7 days from induction) and the day of loss of response"},{"outcome_type":"secondary","measure":"Event-free survival (EFS)","time_frame":"up to 1 year after end of treatment","description":"EFS probability of all participants enrolled in this trial from start of treatment and up to 1 year after the end of treatment."},{"outcome_type":"secondary","measure":"Overall survival (OS)","time_frame":"up to 1 year after end of treatment","description":"OS probability of all participants enrolled in this trial from start of treatment and up to 1 year after the end of treatment."}]}
{"nct_id":"NCT03739190","start_date":"2019-07-22","phase":"Phase 4","enrollment":470,"brief_title":"A Clinical Investigation to Assess the Performance of Natural Rubber Latex Condoms in Couples","official_title":"A 3-way Cross-over, Multi-centre Clinical Investigation to Evaluate the Performance Rate of Natural Rubber Latex Condoms of Varying Thickness in Healthy Monogamous Couples","primary_completion_date":"2019-12-27","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-12-27","last_update":"2020-03-12","description":"This investigation is designed to evaluate the performance rate of a new natural rubber latex (NRL) male condom.","other_id":"5005901","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Other","masking_description":"Triple","intervention_model_description":"The condom types will be tested in a three-way cross-over design where couples will be randomised to use each of the three condom types in a defined order, according to the randomisation schedule.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. A male and a female subject aged: 18 - 60 years inclusive.\r\n\r\n          2. All subjects must be generally healthy and in a mutually monogamous heterosexual\r\n             relationship - current relationship  3 months.\r\n\r\n          3. All couples must be sexually active, and agree to have penile-vaginal intercourse with\r\n             a frequency sufficient to meet protocol requirements (a minimum of 5 coital acts over\r\n             4 weeks).\r\n\r\n          4. The female partner should use one other established highly effective form of\r\n             non-barrier contraception, unless post-menopausal.\r\n\r\n          5. Couples must agree not to use drugs or non-investigational devices that can affect\r\n             sexual performance e.g. medication/medical devices used to treat erectile dysfunction.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Either partner is or becomes aware of an allergy or sensitivity to the ingredients of\r\n             the test products, including the test or control condoms or any lubrication products\r\n             provided.\r\n\r\n          2. Either partner has a pre-existing skin condition (severe eczema/psoriasis) or systemic\r\n             allergic reactions or as confirmed by the subject and physical examination.\r\n\r\n          3. Either partner that needs to use condoms for a specific sexually transmitted infection\r\n             (STI) protection e.g. discordance for Human Immunodeficiency Virus (HIV) or herpes.\r\n\r\n          4. Subjects that have previous or planned genital surgery, that in the opinion of the\r\n             Investigator would consider the subject unsuitable to participate in the clinical\r\n             investigation e.g. laser for abnormal smear.\r\n\r\n          5. Male partners that have known erectile or ejaculatory dysfunction.\r\n\r\n          6. Either partner that requires to use/is using medication or preparations that are\r\n             applied topically to the genitalia area or intravaginally other than that supplied for\r\n             the investigation.\r\n\r\n          7. A female partner that has been diagnosed with or treated for vaginal complaints\r\n             (including vaginal dryness) in the previous 3 months which, in the opinion of the\r\n             investigator, deems the partner unsuitable for the investigation.\r\n\r\n          8. Any participant who has clinical symptoms or signs of a sexually transmitted diseases\r\n             (STD) or HIV/AIDS or has a previous history of high risk behaviour as judged by the\r\n             investigator.\r\n\r\n          9. Female partner using medication which in the investigators opinion would affect\r\n             vaginal mucosal secretion, such as Chlorpheniramine at any time in the 14 days (or 5\r\n             half-lives of the drug, whichever is longer) before first condom use.\r\n\r\n         10. A male partner with abnormal penile anatomy that would, in the opinion of the\r\n             investigator, affect the ability to keep the condom in place during intercourse.\r\n\r\n         11. Either partner intends to continue to use antihistamines, anti-inflammatory drugs or\r\n             pain killers for the duration of the investigation.\r\n      ","sponsor":"Reckitt Benckiser Healthcare (UK) Limited","sponsor_type":"Industry","conditions":"Control of Pregnancy|Prevention of Sexually Transmitted Infections","interventions":[{"intervention_type":"Device","name":"Device: NRL Condom","description":"A minimum of 5 condoms (maximum 7 condoms) of each condom type will be provided to Subjects to be used during vaginal intercourse over a 4 week period, the assessment period. Couples will repeat the assessment period each of the 3 condom types."}],"outcomes":[{"outcome_type":"primary","measure":"Compared clinical failure rate of condom use between the test condom group and the reference condom A group","time_frame":"within 2 hours following each coital act for each condom use","description":"Number of clinical failure events, defined in ISO 29943-1:2017, will be reported by participants.\r\nClinical failure rate is calculated as the number of condoms with at least 1 acute failure event (clinical slippage or clinical breakage) divided by the number of condoms used during intercourse, reported as a percentage. A condom that experiences multiple clinical failure events only counts as a single clinical failure."},{"outcome_type":"secondary","measure":"Compared clinical failure rate of condom use between the test condom group and the reference condom B group","time_frame":"within 2 hours following each coital act for each condom use","description":"Number of clinical failure events, defined in ISO 29943-1:2017, will be reported by participants.\r\nClinical failure rate is calculated as the number of condoms with at least 1 acute failure event (clinical slippage or clinical breakage) divided by the number of condoms used during intercourse, reported as a percentage. A condom that experiences multiple clinical failure events only counts as a single clinical failure."},{"outcome_type":"secondary","measure":"Compared clinical failure rate of condom use between the test condom group, the reference condom A group and reference condom B group","time_frame":"within 2 hours following each coital act for each condom use","description":"Number of clinical failure events, defined in ISO 29943-1:2017, will be reported by participants.\r\nClinical failure rate is calculated as the number of condoms with at least 1 acute failure event (clinical slippage or clinical breakage) divided by the number of condoms used during intercourse, reported as a percentage. A condom that experiences multiple clinical failure events only counts as a single clinical failure."},{"outcome_type":"secondary","measure":"Incidence of treatment-emergent adverse events and adverse device effects, defined in MEDDEV 2.7/3","time_frame":"16 weeks"},{"outcome_type":"secondary","measure":"Subject's experience on the use of each type of condoms [Acceptability and Tolerability]","time_frame":"16 weeks","description":"Acceptability and tolerability as assessed by subject perceived questionnaires"}]}
{"nct_id":"NCT03965195","start_date":"2019-07-20","phase":"Phase 4","enrollment":1989,"brief_title":"Recombinant Influenza Vaccination in U.S. Nursing Homes","official_title":"Comparative Effectiveness of Recombinant Versus Standard Dose Quadrivalent Influenza Vaccine in U.S. Nursing Homes","primary_completion_date":"2021-08-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2022-12-31","last_update":"2020-09-25","description":"Based on recent evidence on the mutation of the A/H3N2 strain in egg-grown vaccine, the investigators will study the quadrivalent recombinant influenza vaccine (RIV4, Flublok) compared to the standard dose quadrivalent vaccine (IV4) in a cohort of long-stay NH residents with a primary endpoint of all-cause hospitalization.","other_id":"INSI-201902","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":120,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Medicare-certified NHs with at least 50 long-stay residents  18 years of age\r\n\r\n          -  Facilities with at least 80% of their long-stay population  65 years of age or at\r\n             least 70 long stay residents  65 years of age that make up  45% of their total\r\n             number of beds\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Hospital-based facilities\r\n\r\n          -  Facilities where Fluzone High-Dose or Fluad was used in the previous influenza season\r\n             (2018-19 or 2019-20), or who's leadership plans to use one of these vaccines in the\r\n             2019- 2020 or 2020-21 season\r\n\r\n          -  Facilities not submitting MDS data\r\n\r\n          -  Facilities not in one of the 50 U.S. states\r\n      ","sponsor":"Insight Therapeutics, LLC","sponsor_type":"Other","conditions":"Influenza|Influenza -Like Illness|Influenza, Human","interventions":[{"intervention_type":"Biological","name":"Biological: Recombinant Influenza Vaccine","description":"Nursing home residents and staff 18 years and older are allocated to receive quadrivalent recombinant influenza vaccine."},{"intervention_type":"Biological","name":"Biological: Standard Dose Quadrivalent Influenza Vaccine","description":"Nursing home residents and staff 18 years and older are allocated to receive standard dose quadrivalent influenza vaccine"}],"outcomes":[{"outcome_type":"primary","measure":"Differences in all-cause hospitalization rates during the 2019-20 and 2020-21 influenza seasons","time_frame":"Up to 8 months each influenza season","description":"To determine the differences in all-cause hospitalization rates during the 2019-20 and 2020-21 influenza seasons experienced by all long-stay nursing home residents 18 years of age and older in facilities randomized to offer either quadrivalent recombinant influenza vaccine (RIV4) or standard dose quadrivalent influenza vaccine (IV4)."},{"outcome_type":"secondary","measure":"Differences in each pneumonia and influenza-related hospitalization rates","time_frame":"Up to 8 months each influenza season","description":"To determine the differences in each pneumonia and influenza-related hospitalization rates during the 2019-20 and 2020-21 influenza seasons experienced by long-stay nursing home residents in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older."},{"outcome_type":"secondary","measure":"Differences in pneumonia-related hospitalization rates","time_frame":"Up to 8 months each influenza season","description":"To determine the differences in each pneumonia-related hospitalization rates during the 2019-20 and 2020-21 influenza seasons experienced by long-stay nursing home residents in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older."},{"outcome_type":"secondary","measure":"Differences in major adverse cardiovascular event-related (MACE) hospitalization rates","time_frame":"Up to 8 months each influenza season","description":"To determine the differences in each major adverse cardiovascular event-related (MACE) hospitalization rates during the 2019-20 and 2020-21 influenza seasons experienced by long-stay nursing home residents in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older."},{"outcome_type":"secondary","measure":"Differences in cardiorespiratory-related hospitalization rates","time_frame":"Up to 8 months each influenza season","description":"To determine the differences in long-stay residents' cardiorespiratory-related hospitalization rates each season and across two seasons in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older."},{"outcome_type":"secondary","measure":"Differences in ICU stay","time_frame":"Up to 8 months each influenza season","description":"To determine the differences in long-stay residents' ICU stay each season and across two seasons in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older."},{"outcome_type":"secondary","measure":"Differences in mortality rates","time_frame":"Up to 8 months each influenza season","description":"To determine the differences in long-stay residents' mortality rates each influenza season and both seasons in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older."},{"outcome_type":"secondary","measure":"Differences in activities of daily living (ADL) function score","time_frame":"Up to 8 months each influenza season","description":"To determine the differences in long-stay residents' composite Activities of Daily Living (ADL) function score based on the MDS experienced during the influenza season by selected comorbidities and specific to respiratory illness, in facilities randomized to either RIV4 or IV4 combined over two seasons for each, residents 18 years of age and older and those 65 years of age and older."},{"outcome_type":"secondary","measure":"Differences in facility-reported outbreaks","time_frame":"Up to 8 months each influenza season","description":"To determine differences in facility-reported outbreaks each season and across two seasons in facilities randomized to either RIV4 or IV4"},{"outcome_type":"secondary","measure":"Differences in all-cause hospitalization rates","time_frame":"Up to 8 months each influenza season","description":"To determine differences in long-stay residents' all-cause hospitalization rates as an interim exploratory analysis based on the Minimum Data Set 3.0 for each, residents 18 years of age and older and those 65 years of age and older."}]}
{"nct_id":"NCT04215393","start_date":"2019-07-18","phase":"Phase 1","enrollment":39,"brief_title":"An Exploratory Clinical Trial Evaluating the Tolerability and Efficacy of KH906 in Patients With Corneal Neovascularization","official_title":"An Exploratory Clinical Trial Evaluating the Tolerability and Efficacy of Conbercept Eye Drops in Patients With Corneal Neovascularization","primary_completion_date":"2020-04-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2020-12-31","last_update":"2020-01-02","description":"The first stage of this study will evaluates the tolerability of different concentrations of Conbercept eye drop to patients with corneal neovascularization. The second stage of this study will evaluate the effectiveness of conbercept eye drop initially.","other_id":"KH906-40101","allocation":"Non-Randomized","intervention_model":"Sequential Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Signed the informed consent form, volunteered to participate in the trial and followed\r\n             up according to the protocol.\r\n\r\n          -  Ages from 18 to 75,male or female.\r\n\r\n          -  Superficial or deep neovascularization induced by trauma/chemical\r\n             burn/inflammation/corneal transplantation.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subjects who had significant defect in the corneal epithelium.\r\n\r\n          -  Study eye had been injected of anti-vegf drugs within 3 months before screening\r\n\r\n          -  Study eye was performed surgery (except keratoplasty) within 3 months prior screening,\r\n             or eye surgery was planned during this trial period.\r\n\r\n          -  Oral glucocorticoid administration within 1 month prior screening (except for duration\r\n             less than 7 days)\r\n\r\n          -  Systemic use of anti-vegf drugs within 45 days prior to screening.\r\n\r\n          -  Have history of abnormal coagulation, such as end-stage liver disease, or are taking\r\n             anticoagulantsexcept aspirin.\r\n\r\n          -  Uncontrolled clinical problems such as canner etc..\r\n\r\n          -  Unable or unwilling to use effective contraception.\r\n\r\n          -  Positive blood tests for pregnancy (female subjects)\r\n\r\n          -  Participated in drug clinical trials within 3 months before the first administration.\r\n\r\n          -  The researchers think the participants were not suitable for this trail.\r\n      ","sponsor":"Chengdu Kanghong Biotech Co., Ltd.","sponsor_type":"Industry","conditions":"Corneal Neovascularization","interventions":[{"intervention_type":"Drug","name":"Drug: Conbercept eye drop","description":"In the first stage, subjects will be receive Conbercept eye drop. In the second stage,subjests will revceive conbercept eye drop or placebo."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"In the second stage, subjects will be receive Conbercept eys drop or a placebo."}],"outcomes":[{"outcome_type":"primary","measure":"Ocular and Systemic Safety: occurrence of ocular and systemic adverse events","time_frame":"day 14","description":"The occurrence of ocular and systemic adverse events was closely monitored over the course of this study. Ocular adverse events were monitored through complete ocular examinations. Systemic adverse events were identified with physical examinations."},{"outcome_type":"secondary","measure":"The Size and Extent of Corneal Neovascularization Will be Measured by Computerized Image Analysis of Corneal Photographs Taken Throughout the Study","time_frame":"day 14 and day 28","description":"The efficacy of KH906 in the treatment of corneal NV was evaluated by comparing corneal photographs taken at baseline with corneal photographs taken at the follow-up visits. Percent change from baseline was measured."}]}
{"nct_id":"NCT03994783","start_date":"2019-07-17","phase":"Phase 3","enrollment":3,"brief_title":"Transplant Antibody-Mediated Rejection: Guiding Effective Treatments","official_title":"A Multicentre Randomised Controlled Trial to Assess the Efficacy of Adding Rituximab to Standard of Care in Treating Acute Antibody-mediated Rejection in Kidney Transplantation","primary_completion_date":"2027-07-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2027-07-31","last_update":"2021-04-01","description":"This trial evaluates the addition of rituximab to standard of care in the treatment of antibody-mediated rejection in kidney transplant patients. The trial will involve adults and children. Half of participants will receive standard of care (methylprednisolone, intravenous immunoglobulin and plasma exchange), while the other half will receive standard of care and rituximab.","other_id":"2018-002882-20","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":5,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Willing and able to give written informed consent by patient aged 16 years and over;\r\n             or by a parent or legal guardian for patients who are under 16 years old\r\n\r\n          -  5 years old or older\r\n\r\n          -  A diagnosis of acute AMR as defined by:\r\n\r\n          -  The presence of 1 donor specific antibodies (DSA)\r\n\r\n          -  An adequate renal transplant biopsy with histological features consistent with active\r\n             AMR with no evidence of chronicity as defined by the Banff histological classification\r\n             of allograft pathology:\r\n\r\n          -  If C4d positive (2 or 3):\r\n\r\n          -  v score 1 and/or\r\n\r\n          -  g score 1 and/or\r\n\r\n          -  thrombotic microangiopathy and/or\r\n\r\n          -  ptc score 1\r\n\r\n          -  or if co-existent cellular rejection, a g score of 1 OR\r\n\r\n          -  If C4d negative (0 or 1):\r\n\r\n          -  microcirculation inflammatory score (g + ptc) 2\r\n\r\n          -  or if co-existing cellular rejection, a g score 1 and (g + ptc) 2 AND\r\n\r\n          -  Chronic glomerulopathy (cg) score 0 or 1a\r\n\r\n          -  Tubulo-interstitial fibrosis <50% and glomerular obsolescence <50%\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who have received an ABO incompatible transplant\r\n\r\n          -  Patients who have received rituximab as part of induction or post-transplant for any\r\n             other indications (e.g. recurrent focal and segmental glomerular sclerosis)\r\n\r\n          -  Patients who have completed PEX treatment prior to the index biopsy on the suspicion\r\n             of acute AMR in the absence of histology\r\n\r\n          -  Have active infection including bacterial, viral (including CMV (cytomegalovirus) and\r\n             EBV (Epstein-Barr virus)), fungal or tuberculosis, which in the investigator's opinion\r\n             could affect the conduct of the trial\r\n\r\n          -  Co-existing BK (BK virus) nephropathy\r\n\r\n          -  Patients with hepatitis B (patients with prior exposure to hepatitis B may be enrolled\r\n             at the discretion of the PI)\r\n\r\n          -  Have active hepatitis C (patients may be included if a negative hepatitis C\r\n             recombinant immunoblot assay is confirmed or have a negative hepatitis C virus RNA\r\n             [qualitative] test)\r\n\r\n          -  Have human immunodeficiency virus (HIV)\r\n\r\n          -  Active malignancy, which would pose a contraindication to any of the trial\r\n             interventions\r\n\r\n          -  Patients with known allergy, intolerance or contraindication to treatments in the\r\n             standard of care arm or rituximab as outlined in the Summaries of Product\r\n             Characteristics (SmPCs)\r\n\r\n          -  Clinically significant comorbidity\r\n\r\n          -  Females must be either post-menopausal for at least 1 year, surgically sterile or, if\r\n             of child-bearing potential, must not be pregnant or lactating. If sexually active,\r\n             female participants must agree to use an acceptable method of birth control for 12\r\n             months post treatment with rituximab. Female participants must also agree not to\r\n             breastfeed for 12 months post treatment with rituximab.\r\n      ","sponsor":"Imperial College London","sponsor_type":"Other","conditions":"Kidney Transplant Rejection|Antibody-mediated Rejection","interventions":[{"intervention_type":"Drug","name":"Drug: Rituximab","description":"2 intravenous infusions of rituximab or approved biosimilar given 14 days +/- 2 days apart."},{"intervention_type":"Drug","name":"Drug: Methylprednisolone","description":"Intravenous infusion of methylprednisolone"},{"intervention_type":"Drug","name":"Drug: Intravenous Immunoglobulin","description":"High dose (2 g/kg total) or Low dose (100 mg/kg, n=7)"},{"intervention_type":"Procedure","name":"Procedure: Plasma Exchange","description":"Blood is removed from the patient and filtered to remove the plasma. Red and white blood cells and platelets are returned to the patient with replacement fluid."}],"outcomes":[{"outcome_type":"secondary","measure":"Change in mean fluorescence index of donor specific antibodies as assessed by blood test","time_frame":"3 and 12 months","description":"Change in mean fluorescence index of donor specific antibodies from baseline"},{"outcome_type":"secondary","measure":"Incidence rate of adverse event as assessed by questionnaire","time_frame":"4 years","description":"Summary tables of incidence rates for adverse event reporting of participants receiving rituximab in addition to standard of care compared to participants receiving standard of care alone"},{"outcome_type":"primary","measure":"Allograft Survival as assessed by statistical model","time_frame":"4 years","description":"Statistical model measuring allograft survival as defined as duration from the date of randomisation to the date of eGFR ≤15 mL/min/1.72 m2 (where the eGFR measurement is not due to an acute reversible cause, as determined by the PI, or a follow-up consecutive eGFR measurement of ≤15 mL/min/1.72 m2 is recorded (where the first date is recorded as the date of failure)), or the date of renal replacement therapy (date of starting maintenance dialysis dependency, retransplantation etc), whichever occurs first."},{"outcome_type":"secondary","measure":"Serum creatinine as assessed by blood test","time_frame":"1, 3, 6 and 12 months, 2, 3 and 4 years","description":"Serum creatinine is an allograft function. Change in serum creatinine from baseline at 1, 3, 6 and 12 months post-randomisation and then annually until 4 years"},{"outcome_type":"secondary","measure":"Estimated glomerular filtration rate (eGFR) as assessed by blood test","time_frame":"1, 3, 6 and 12 months, 2, 3 and 4 years","description":"eGFR is an allograft function. Change in eGFR from baseline at 1, 3, 6 and 12 months post-randomisation and then annually until 4 years"},{"outcome_type":"secondary","measure":"Proteinuria as assessed by urine test","time_frame":"1, 3, 6 and 12 months, 2, 3 and 4 years","description":"Proteinuria is an allograft function. Change in proteinuria from baseline at 1, 3, 6 and 12 months post-randomisation and then annually until 4 years. Proteinuria is a ratio between urinary protein and creatinine."},{"outcome_type":"secondary","measure":"Change in donor specific antibodies as assessed by blood test","time_frame":"3 and 12 months","description":"Change in number of donor specific antibodies from baseline"},{"outcome_type":"secondary","measure":"Change in positivity of donor specific antibodies as assessed by blood test","time_frame":"3 and 12 months","description":"Change in positivity of donor specific antibodies from baseline"},{"outcome_type":"secondary","measure":"Health-related quality of life (QoL) as assessed by EuroQoL EQ-5D-5L/EQ-5D-Y questionnaire","time_frame":"3 months, 1, 2, 3 and 4 years","description":"A QoL score is obtained according to the answers to the EQ-5D-5L/EQ-5D-Y questionnaires. The QoL score comprises of 2 numbers. The first is a 5-digit number for the EQ-5D-5L descriptive system describing the 5 dimensions asked in the questionnaire. For example 11111 indicates no problems on any of the 5 dimensions whilst 55555 indicates extreme problems on all of the 5 dimensions. The second number is the EQ-VAS (EuroQoL-Visual Analogue Scale) score. This is a value between 0 and 100 where 0 is the worst health the respondent can imagine and 100 is the best health."},{"outcome_type":"secondary","measure":"Cost effectiveness economic analysis","time_frame":"4 years","description":"Statistical decision model built for economic analysis of cost per quality-adjusted life year gained from perspective of the National Health Service"}]}
{"nct_id":"NCT03674658","start_date":"2019-07-11","phase":"N/A","enrollment":72,"brief_title":"Propafenone in the Treatment of Atrial Fibrillation","official_title":"An Open-Label Randomized Study of Propafenone in the Treatment of Atrial Fibrillation","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-12-31","last_update":"2020-10-08","description":"This is a open label randomized, multi-center study conducted in Taiwan. The study aims to evaluate the effectiveness and safety of oral Rhynorm (A drug) and Rytmonorm (B drug) for the conversion of paroxysmal AF and is designed to evaluate the improvement in sinus rhythm restoration after the treatment with Rhynorm (A drug) and Rytmonorm (B drug) for 24 weeks.","other_id":"TSHRH1801-P","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Group A: Rhynorm (A drug) Group B: Rytmonorm (B drug)","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patients who are 20~80 years of age\r\n\r\n          2. Recurrent AF patients\r\n\r\n          3. Patients with paroxysmal atrial fibrillation\r\n\r\n          4. Patients diagnosed with one of the ECG monitoring within 12 months prior screening\r\n             visit:\r\n\r\n               1. 12-lead electrocardiogram\r\n\r\n               2. ECG used to make a 30 second one of recording\r\n\r\n               3. 24 hours ECG (Holter Monitor)\r\n\r\n               4. Long term ECG (Event Monitor)\r\n\r\n          5. Patient may be receiving stable dose of propafenone since at least 4 weeks prior\r\n             screening visit.\r\n\r\n          6. Agree to and are able to follow the study procedures\r\n\r\n          7. Understand the nature of the study, and have signed informed consent forms\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Permanent or persistent AF\r\n\r\n          2. Any of the following heart disease:\r\n\r\n               1. New York Heart Association class III or IV angina pectoris or heart failure\r\n\r\n               2. previous electrocardiographic evidence of second- or third-degree\r\n                  atrioventricular block;\r\n\r\n               3. Sinus node disease, AV conduction disturbance or bundle branch block in the\r\n                  absence of an artificial pacemaker\r\n\r\n               4. Hemodynamic moderate valvular heart disease (stenosis and/or incompetent;\r\n                  regurgitation)\r\n\r\n               5. Brugada syndrome\r\n\r\n               6. Left ventricular EF< 50%\r\n\r\n               7. Acute myocardial infarction or unstable angina within the previous 12 months\r\n\r\n               8. Cardiogenic shock (excluding arrhythrmia shock) within the previous 12 months\r\n\r\n               9. Acute pericarditis or myocarditis within the previous 6 months\r\n\r\n              10. Cardiac or thoracic surgery within the previous 6 months\r\n\r\n          3. Symptomatic Bradycardia (heart rate less than 50 beats per minute)\r\n\r\n          4. Hemodynamic instability, defined as hypotension (SBP < 90 mm Hg)\r\n\r\n          5. Hyperthyroidism\r\n\r\n          6. Bronchospastic disorders or severe obstructive pulmonary disease\r\n\r\n          7. Correctable AF for other reasons\r\n\r\n          8. Marked electrolyte imbalance\r\n\r\n          9. Patients with clinically significant abnormalities in the following laboratory\r\n             parameters:\r\n\r\n               1. AST or ALT  3X upper limit of normal (ULN)\r\n\r\n               2. Total bilirubin  2X ULN\r\n\r\n               3. Creatinine  2.5 mg/dL\r\n\r\n               4. Hemoglobin < 10 g/dL\r\n\r\n               5. Platelet < 100,000/uL\r\n\r\n         10. Patients with known contraindication or history of allergy to Propafenone.\r\n\r\n         11. Female patients who are pregnant or lactating.\r\n\r\n         12. Female patients of child-bearing potentiality who do not agree to use an effective\r\n             method of contraception during the study\r\n\r\n         13. Patients currently participating in any drug related clinical trial within 30 days\r\n\r\n         14. Patients with propagating factor (e.g. Alcohol Abuse induced AF)\r\n      ","sponsor":"TSH Biopharm Corporation Limited","sponsor_type":"Industry","conditions":"Atrial Fibrillation","interventions":[{"intervention_type":"Drug","name":"Drug: Propafenone","description":"oral, TID"}],"outcomes":[{"outcome_type":"primary","measure":"proportion of patients with recurrent AF","time_frame":"24 weeks treatment","description":"To compare the effect of Rhynorm (A drug) and Rytmonorm (B drug) over 24 weeks of treatment based on the proportion of patients with recurrent AF"}]}
{"nct_id":"NCT04012307","start_date":"2019-07-11","phase":"Phase 1","enrollment":40,"brief_title":"The Bioequivalence Study of Two Different Formulations of Candesartan Cilexetil After a Single Oral Dose Administration Under Fasting Conditions","official_title":"Single Dose Crossover Comparative Bioavailability Study of Candesartan Cilexetil 32 mg Tablets in Healthy Adult Subjects Under Fasting Conditions","primary_completion_date":"2019-08-13","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-08-14","last_update":"2019-11-18","description":"This single dose study was designed in accordance with EMA (the European Medicines Agency) regulatory guidelines, with the aim of characterizing the bioavailability of candesartan in the two formulations in healthy subjects. As this is a bioequivalence trial where each subject received each study treatment in a crossover fashion, a control group was not included. Within the clinical portion of the study each subject received a single oral dose of the test and the reference formulation in compliance with the generated randomization code. The primary study endpoints were the pharmacokinetic (PK) parameters Cmax and AUC0-t of candesartan.","other_id":"PTL-P8-977 (v.1.3 06/26/2019)","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Other","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Provision of signed and dated informed consent form (ICF)\r\n\r\n          2. Stated willingness to comply with all study procedures and availability for the\r\n             duration of the study\r\n\r\n          3. Healthy Caucasian adult male or female\r\n\r\n          4. If female, meets one of the following criteria:\r\n\r\n        (1) Physiological postmenopausal status, defined as the following:\r\n\r\n        a) absence of menses for at least one year prior to the first study drug administration\r\n        (without an alternative medical condition); and b) Follicle stimulating hormone (FSH)\r\n        levels  40 mIU/mL at screening; or (2) Surgical postmenopausal status, defined as the\r\n        following:\r\n\r\n          1. bilateral oophorectomy; and\r\n\r\n          2. absence of menses for at least 90 days prior to the first study drug administration;\r\n             and\r\n\r\n          3. FSH levels  40 mIU/mL at screening; or (3) Hysterectomy with FSH levels  40 mIU/mL\r\n             at screening If postmenopausal and has an FSH of < 40 mIU/mL, but meets all other\r\n             criteria in (1), (2) or (3) above as well as all the other inclusion criteria,\r\n             screening estradiol serum level must be equal to or below 150 pmol/L. In the case of\r\n             hysterectomy, if FSH and estradiol do not meet the criteria, eligibility for study\r\n             participation will be based on medical judgment.\r\n\r\n             5. Aged at least 18 years but not older than 55 years\r\n\r\n             6. Body mass index (BMI) within 18.5 kg/m2 to 30.0 kg/m2, inclusively\r\n\r\n             7. Non- or ex-smoker (An ex-smoker is defined as someone who completely stopped using\r\n             nicotine products for at least 180 days prior to the first study drug administration)\r\n\r\n             8. Clinical laboratory values within the laboratory's stated normal range; if not\r\n             within this range, they must be without clinical significance, as determined by an\r\n             investigator\r\n\r\n             9. Have no clinically significant diseases captured in the medical history or evidence\r\n             of clinically significant findings on the physical examination (including vital signs)\r\n             and/or ECG, as determined by an investigator\r\n\r\n             Exclusion Criteria:\r\n\r\n               1. Female who is lactating at screening\r\n\r\n               2. Female who is pregnant according to the pregnancy test at screening or prior to\r\n                  the first study drug administration\r\n\r\n               3. Seated pulse rate less than 50 Beats per Minute (bpm) at the screening visit and\r\n                  prior to the first study drug administration\r\n\r\n               4. Seated blood pressure below 110/60 mmHg at the screening visit and prior to the\r\n                  first study drug administration\r\n\r\n               5. History of significant hypersensitivity to candesartan or any related products\r\n                  (including excipients of the formulations) as well as severe hypersensitivity\r\n                  reactions (like angioedema) to any drugs\r\n\r\n               6. Presence or history of significant gastrointestinal, liver or kidney disease, or\r\n                  any other condition (including but not limited to cholecystectomy) that is known\r\n                  to interfere with drug absorption, distribution, metabolism or excretion, or\r\n                  known to potentiate or predispose to undesired effects\r\n\r\n               7. History of significant cardiovascular, pulmonary, hematologic, neurological,\r\n                  psychiatric, endocrine, immunologic or dermatologic disease\r\n\r\n               8. Presence of clinically significant ECG abnormalities at the screening visit, as\r\n                  defined by medical judgment\r\n\r\n               9. History of rare hereditary problems of galactose and/or lactose intolerance,\r\n                  lactase deficiency or glucose-galactose malabsorption\r\n\r\n              10. Maintenance therapy with any drug or significant history of drug dependency or\r\n                  alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute\r\n                  or chronic)\r\n\r\n              11. Any clinically significant illness in the 28 days prior to the first study drug\r\n                  administration\r\n\r\n              12. Use of any prescription drugs (with the exception of hormone replacement therapy)\r\n                  in the 28 days prior to the first study drug administration, that in the opinion\r\n                  of an investigator would put into question the status of the participant as\r\n                  healthy\r\n\r\n              13. Any history of tuberculosis\r\n\r\n              14. Positive test result for alcohol and/or drugs of abuse at screening or prior to\r\n                  the first drug administration\r\n\r\n              15. Positive screening results to HIV Ag/Ab Combo, Hepatitis B surface Antigen\r\n                  (HBsAG) or Hepatitis C Virus (HCV) tests\r\n\r\n              16. Inclusion in a previous group for this clinical study\r\n\r\n              17. Intake of candesartan in the 28 days prior to the first study drug administration\r\n\r\n              18. Intake of an Investigational Product (IP) in the 28 days prior to the first study\r\n                  drug administration\r\n\r\n              19. Donation of 50 mL or more of blood in the 28 days prior to the first study drug\r\n                  administration\r\n\r\n              20. Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec,\r\n                  clinical studies, etc.) in the 56 days prior to the first study drug\r\n                  administration\r\n      ","sponsor":"Pharmtechnology LLC","sponsor_type":"Industry","conditions":"Bioequivalence","interventions":[{"intervention_type":"Drug","name":"Drug: Candesartan Cilexetil 32mg","description":"Candesartan Cilexetil is manufactured by Pharmtechnology LLC, Republic of Belarus. Each tablet contains 32 mg of candesartan cilexetil."},{"intervention_type":"Drug","name":"Drug: Atacand PROTECT","description":"Atacand PROTECT is manufactured by AstraZeneca GmbH, Germany. Each tablet contains 32 mg of candesartan cilexetil."}],"outcomes":[{"outcome_type":"primary","measure":"Cmax of candesartan in plasma after administration of the test and the reference products.","time_frame":"Time points 0.00 (prior to each drug administration) and 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 hours after each drug administration.","description":"Maximum observed concentration in plasma."},{"outcome_type":"primary","measure":"AUC0-t of candesartan in plasma after administration of the test and the reference products.","time_frame":"Time points 0.00 (prior to each drug administration) and 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 hours after each drug administration.","description":"Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration (TLQC) using the linear trapezoidal method."},{"outcome_type":"secondary","measure":"Tmax of candesartan in plasma after administration of the test and the reference products.","time_frame":"Time points 0.00 (prior to each drug administration) and 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 hours after each drug administration.","description":"Time of maximum observed concentration; if it occurs at more than one time point, Tmax is defined as the first time point with this value."},{"outcome_type":"secondary","measure":"TLQC of candesartan in plasma after administration of the test and the reference products.","time_frame":"Time points 0.00 (prior to each drug administration) and 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 hours after each drug administration.","description":"Time of last observed quantifiable concentration."},{"outcome_type":"secondary","measure":"AUC0-INF of candesartan in plasma after administration of the test and the reference products.","time_frame":"Time points 0.00 (prior to each drug administration) and 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 hours after each drug administration.","description":"Area under the concentration time curve extrapolated to infinity, calculated as AUC0-t + ĈLQC (the predicted concentration at time TLQC) / λZ (apparent elimination rate constant)."},{"outcome_type":"secondary","measure":"Residual area of candesartan in plasma after administration of the test and the reference products.","time_frame":"Time points 0.00 (prior to each drug administration) and 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 hours after each drug administration.","description":"Extrapolated area (i.e. percentage of AUC0-INF due to extrapolation from TLQC to infinity)."},{"outcome_type":"secondary","measure":"Time point where the log-linear elimination phase begins (TLIN) of candesartan in plasma after administration of the test and the reference. products.","time_frame":"Time points 0.00 (prior to each drug administration) and 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 hours after each drug administration.","description":"Time point where the log-linear elimination phase begins."},{"outcome_type":"secondary","measure":"λZ of candesartan in plasma after administration of the test and the reference products.","time_frame":"Time points 0.00 (prior to each drug administration) and 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 hours after each drug administration.","description":"Apparent elimination rate constant, estimated by linear regression of the terminal linear portion of the log concentration versus time curve."},{"outcome_type":"secondary","measure":"Terminal elimination half-life (Thalf) of candesartan in plasma after administration of the test and the reference products.","time_frame":"Time points 0.00 (prior to each drug administration) and 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 hours after each drug administration.","description":"Terminal elimination half-life, calculated as ln(2)/λZ."},{"outcome_type":"secondary","measure":"Number of treatment-emergent adverse events for the test and the reference products.","time_frame":"Up to 11 days (after the first drug administration until the end of the period of 1 day following the last blood sample of the study)","description":"The safety population will include all subjects who received at least one dose of the test or the reference product. Any significant changes will be recorded as treatment-emergent adverse events only if they are judged clinically significant by the qualified investigator or delegate."}]}
{"nct_id":"NCT04068662","start_date":"2019-07-10","phase":"N/A","enrollment":460,"brief_title":"Intervention for IPV-exposed Pregnant Women","official_title":"Intervening During the Prenatal Period With Women Exposed to Intimate Partner Violence to Improve Maternal Functioning and Infant Adjustment","primary_completion_date":"2023-12-20","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-12-20","last_update":"2021-08-05","description":"The overarching goal of the proposed project is to evaluate a randomized clinical trial of the Pregnant Moms' Empowerment Program aimed at detecting its effects on maternal mental health, re-victimization, parenting sensitivity, and infant development. The project also seeks to examine theoretically-grounded mechanisms of change, including social support and empowerment. Women participating in the study will receive either the PMEP or participate in a contact-equivalent active control group during pregnancy, and will be interviewed at baseline, post-intervention and with their infants at 3 months and 1 year old. The study will occur at two sites - the University of Notre Dame and the University of Memphis. Participants will be recruited from the local community at both locations, with an equal number of women drawn from each site - Memphis, Tennessee (n=115) and South Bend, Indiana (n=115). Enrollment will continue for approximately 2.5 years, with an expected rate of 8 eligible women per month, based on a pilot study of the Pregnant Moms' Empowerment Program. The expected duration of the study for each participant will be approximately 1.5 years, with some variation due to women enrolling at different points in their pregnancy. The primary objective of the proposed project is to determine if the Pregnant Moms' Empowerment Program has positive effects on maternal mental health, re-victimization rates, parenting sensitivity, and infant development compared to women's participation in a contact-equivalent active control group. This objective will be evaluated using a multi-site randomized clinical trial design. Participants (N = 230) will be equally randomized into study arms. Eligible women will include those who are: 1) currently pregnant (primi or multiparous) and between 10 and 30 weeks gestation, 2) experienced IPV within the past year, 3) English speaking and 4) age 16 or older. The study will include 9 total visits: 4 assessments and 5 sessions for both study arms. In-person assessment visits will be completed by a trained research assistant; each visit will take approximately 2-3 hours, with post-partum assessments somewhat longer than prenatal assessments given the addition of the infant developmental assessment and parent-child observation task. Women will be compensated $30 for the first two assessments and $50 for the second two assessments. Following the final assessment, women will be invited to complete a daily diary (virtually) each day for 30 days. Each survey will take approximately 5-10 minutes to complete, and women will be compensated $2 for each completed survey. Women will also receive a $10 bonus for each set of 10 consecutive surveys. Treatment sessions will be 2 hours in duration. Women in the PMEP will complete a structured set of sessions: (1) supporting each other, support in the community, (2) identifying and understanding sources of distress, (3) cognitive and behavioral strategies to build resilience and resolve conflict, (4) perinatal health and infant care, and (5) positive parenting. Women in the active control condition will participate in facilitated discussions on a topic identified by the group. All sessions will be audio recorded so that treatment fidelity can be evaluated (for the Pregnant Moms' Empowerment Program) and so that content overlap can be assessed (for the active control condition).","other_id":"19-03-5260","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","intervention_model_description":"Participants are assigned to either the Pregnant Moms' Empowerment Program or an active control group. Members of the active control group participate in a non-directive support group with contact equivalent time to the Pregnant Moms' Empowerment Program (10 hrs).","sampling_method":"","gender":"Female","minimum_age":0.25,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  currently pregnant (primi or multiparous)\r\n\r\n          -  experienced intimate partner violence within the past year\r\n\r\n          -  English speaking\r\n\r\n          -  age 16 or older\r\n\r\n          -  between 10-30 weeks pregnant\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  fails to meet inclusion criteria\r\n\r\n          -  unavailable or unwilling to participate in core study components, including groups\r\n      ","sponsor":"University of Notre Dame","sponsor_type":"Other","conditions":"Postpartum Depression|Posttraumatic Stress Disorder|Infant Behavior|Violence|Parenting","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Pregnant Moms' Empowerment Program","description":"The Pregnant Moms' Empowerment Program is a five session group therapy program designed for pregnant women with a recent history of exposure to intimate partner violence. One session is administered each week with a duration of 2 hours each, for a total of ten contact hours across the course of the intervention. Intervention topics includes safety planning, social support, resilience, psychoeducation about intimate partner violence, cognitive and behavioral strategies for remediating distress, infant sleep and breastfeeding, responsive parenting, and co-parenting."},{"intervention_type":"Behavioral","name":"Behavioral: Nondirective Support Group","description":"Participants in the non-directive support group condition participate in groups of the same size and with the same total contact time as women in Intervention 1. In contrast to the structured, manualized content delivered as a part of the Pregnant Moms' Empowerment Program, however, group leaders in this condition facilitate open conversation on topics that women identify together as a group."}],"outcomes":[{"outcome_type":"primary","measure":"Change in depressed mood from baseline to 3-months postpartum","time_frame":"3-months postpartum","description":"Mothers will report on symptoms of depressed mood using the Center for Epidemiological Studies Depression Scale (Radloff, 1977). We hypothesize that compared to women in the active control condition, that beginning at that women in the treatment condition will have lower levels of depressed mood over time. Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support. Items are summed to create a total score, which can range from 0 to 60. Higher scores indicate worse outcomes."},{"outcome_type":"primary","measure":"Change in posttraumatic stress symptoms from baseline to post-treatment","time_frame":"posttreatment","description":"Mothers will report on symptoms of posttraumatic stress using the PTSD Checklist for DSM-5 (Weathers, Litz, Keane, Palmieri, Marx, & Schnurr, 2013). We hypothesize that compared to women in the active control condition, that beginning at the post-treatment assessment women in the treatment condition will have lower levels of posttraumatic stress. Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support. Items are summed to create a total score, which can range from 0 to 80. Higher scores indicate worse outcomes."},{"outcome_type":"primary","measure":"Change in posttraumatic stress symptoms from baseline to 3-months postpartum","time_frame":"3-months postpartum","description":"Mothers will report on symptoms of posttraumatic stress using the PTSD Checklist for DSM-5 (Weathers, Litz, Keane, Palmieri, Marx, & Schnurr, 2013). We hypothesize that compared to women in the active control condition, women in the treatment condition will have lower levels of posttraumatic stress. Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support. Items are summed to create a total score, which can range from 0 to 80. Higher scores indicate worse outcomes."},{"outcome_type":"primary","measure":"Change in posttraumatic stress symptoms from baseline to 12-months postpartum","time_frame":"12-months postpartum","description":"Mothers will report on symptoms of posttraumatic stress using the PTSD Checklist for DSM-5 (Weathers, Litz, Keane, Palmieri, Marx, & Schnurr, 2013). We hypothesize that compared to women in the active control condition, women in the treatment condition will have lower levels of posttraumatic stress. Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support. Items are summed to create a total score, which can range from 0 to 80. Higher scores indicate worse outcomes."},{"outcome_type":"primary","measure":"Change in depressed mood from baseline to posttreatment","time_frame":"posttreatment","description":"Mothers will report on symptoms of depressed mood using the Center for Epidemiological Studies Depression Scale (Radloff, 1977). We hypothesize that compared to women in the AC condition, that beginning at the post-treatment assessment (T2) women in the PMEP condition will have lower levels of depressed mood over time. Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support. Items are summed to create a total score, which can range from 0 to 60. Higher scores indicate worse outcomes."},{"outcome_type":"primary","measure":"Change in depressed mood from baseline to 12-months postpartum","time_frame":"12-months postpartum","description":"Mothers will report on symptoms of depressed mood using the Center for Epidemiological Studies Depression Scale (Radloff, 1977). We hypothesize that compared to women in the active control condition, that beginning at that women in the treatment condition will have lower levels of depressed mood over time. Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support. Items are summed to create a total score, which can range from 0 to 60. Higher scores indicate worse outcomes."},{"outcome_type":"primary","measure":"Change in resilience from baseline to posttreatment","time_frame":"posttreatment","description":"Mothers will report on resilience using the Connor-Davidson Resilience Scale (Connor & Davidson, 2003), which examines one's ability to cope with adversity. We hypothesize that compared to women in the active control condition that women in the treatment condition will have higher levels of resilience over time. Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support. Items are summed to create a total score, which can range from 0 to 100. Higher scores indicate better outcomes."},{"outcome_type":"primary","measure":"Change in resilience from baseline to 3-months postpartum","time_frame":"3-months postpartum","description":"Mothers will report on resilience using the Connor-Davidson Resilience Scale (Connor & Davidson, 2003), which examines one's ability to cope with adversity. We hypothesize that compared to women in the active control condition that women in the treatment condition will have higher levels of resilience over time. Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support. Items are summed to create a total score, which can range from 0 to 100. Higher scores indicate better outcomes."},{"outcome_type":"primary","measure":"Change in resilience from baseline to 12-months postpartum","time_frame":"12-months postpartum","description":"Mothers will report on resilience using the Connor-Davidson Resilience Scale (Connor & Davidson, 2003), which examines one's ability to cope with adversity. We hypothesize that compared to women in the active control condition that women in the treatment condition will have higher levels of resilience over time. Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support. Items are summed to create a total score, which can range from 0 to 100. Higher scores indicate better outcomes."},{"outcome_type":"primary","measure":"Maternal Sensitivity at infant age 3 months","time_frame":"3-months postpartum","description":"Maternal sensitivity will be assessed using observational paradigms coded by trained research assistants for sensitive parenting behaviors. At the 3 month and 12 month postpartum assessments, mother-infant dyads will participate in a fixed-order observational assessment, constituted of the Still-Face Paradigm (Tronick et al., 1978) and a 10-minute free play period. Parent sensitivity will be rated on a 5 point Likert scale from the play and reunion episodes. Coded ratings on sensitivity and intrusiveness will be combined across intervals to create a composite maternal sensitivity score. We hypothesize that compared to women in the active control condition, women in the treatment condition will show higher levels of maternal sensitivity at the 3-month postpartum assessment. Higher scores indicate better outcomes."},{"outcome_type":"primary","measure":"Maternal Sensitivity at infant age 12 months","time_frame":"12-months postpartum","description":"Maternal sensitivity will be assessed using observational paradigms coded by trained research assistants for sensitive parenting behaviors. At the 3 month and 12 month postpartum assessments, mother-infant dyads will participate in a fixed-order observational assessment, constituted of the Still-Face Paradigm (Tronick et al., 1978) and a 10-minute free play period. Parent sensitivity will be rated on a 5 point Likert scale from the play and reunion episodes. Coded ratings on sensitivity and intrusiveness will be combined across intervals to create a composite maternal sensitivity score. We hypothesize that compared to women in the active control condition, women in the treatment condition will show higher levels of maternal sensitivity at the 12-month postpartum assessment. Higher scores indicate better outcomes."},{"outcome_type":"primary","measure":"Intimate Partner Violence at posttreatment","time_frame":"posttreatment","description":"The Revised Conflict Tactics Scale (Straus, et al, 1996) will be used to assess the severity of psychological, physical, and sexual violence experienced by women in a dating, cohabiting, or marital relationship. We hypothesize that compared to women in the active control condition that women in the treatment condition will have lower frequency of intimate partner re-victimization over time. Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support. Items cluster into five scales: physical assaults, psychological aggression, sexual coercion, injury, and negotiation techniques. Respondents report frequency on a scale of 1 = once [since the last interview] to 6 = more than 20 times [since the last interview]. Higher scores indicate worse outcomes. The current study used the frequency scoring method for the CTS2, which recodes the scale to represent the midpoints of each range with a possible total range of 0 to 825 events."},{"outcome_type":"primary","measure":"Intimate Partner Violence at 3-months postpartum","time_frame":"3-months postpartum","description":"he Revised Conflict Tactics Scale (Straus, et al, 1996) will be used to assess the severity of psychological, physical, and sexual violence experienced by women in a dating, cohabiting, or marital relationship. We hypothesize that compared to women in the active control condition that women in the treatment condition will have lower frequency of intimate partner re-victimization over time. Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support. Items cluster into five scales: physical assaults, psychological aggression, sexual coercion, injury, and negotiation techniques. Respondents report frequency on a scale of 1 = once [since the last interview] to 6 = more than 20 times [since the last interview]. Higher scores indicate worse outcomes. The current study used the frequency scoring method for the CTS2, which recodes the scale to represent the midpoints of each range with a possible total range of 0 to 825 events."},{"outcome_type":"primary","measure":"Intimate Partner Violence at 12-months postpartum","time_frame":"12-months postpartum","description":"he Revised Conflict Tactics Scale (Straus, et al, 1996) will be used to assess the severity of psychological, physical, and sexual violence experienced by women in a dating, cohabiting, or marital relationship. We hypothesize that compared to women in the active control condition that women in the treatment condition will have lower frequency of intimate partner re-victimization over time. Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support. Items cluster into five scales: physical assaults, psychological aggression, sexual coercion, injury, and negotiation techniques. Respondents report frequency on a scale of 1 = once [since the last interview] to 6 = more than 20 times [since the last interview]. Higher scores indicate worse outcomes. The current study used the frequency scoring method for the CTS2, which recodes the scale to represent the midpoints of each range with a possible total range of 0 to 825 events."},{"outcome_type":"primary","measure":"Infant Development at 3 months of age","time_frame":"3-months","description":"Infant development (cognitive, language, socioemotional) will be evaluated using The Bayley Scales of Infant and Toddler Development and The Ages and Stages Questionnaire - 3, which are a standardized measures. We hypothesize that compared to infants born to women in the active control condition, infants born to mothers in the treatment condition will show better developmental outcomes. Further, we hypothesize that infant development at 12 months will be indirectly predicted by mothers' improvement as a result of treatment at 3 months. The Bayley is a standardized measure and within each domain an average score is 100. Higher scores indicate better outcomes. On the Ages and Stages Questionnaire, scores for each subdomain (Communication, Gross Motor, Fine Motor, Problem Solving, and Personal-Social) range from 0 to 60."},{"outcome_type":"primary","measure":"Infant Development at 12 months of age","time_frame":"12-months","description":"Infant development (cognitive, language, socioemotional) will be evaluated using The Bayley Scales of Infant and Toddler Development and The Ages and Stages Questionnaire - 3, which are a standardized measures. We hypothesize that compared to infants born to women in the active control condition, infants born to mothers in the treatment condition will show better developmental outcomes. Further, we hypothesize that infant development at 12 months will be indirectly predicted by mothers' improvement as a result of treatment at 3 months. The Bayley is a standardized measure and within each domain an average score is 100. Higher scores indicate better outcomes. On the Ages and Stages Questionnaire, scores for each subdomain (Communication, Gross Motor, Fine Motor, Problem Solving, and Personal-Social) range from 0 to 60."},{"outcome_type":"primary","measure":"Infant Regulation at 3 months of age","time_frame":"3-months","description":"At the 3 month and 12 month postpartum assessments, mother-infant dyads will participate in the Still-Face Paradigm (Tronick et al., 1978). Infant affect, which includes a combination of vocal and facial reactions, will be rated on a second-by-second basis across all three episodes of the SFP and free play. A 7 point Likert scale ranging from a -3 (screaming) to +3 (laughing intensely) will be used. Affect data are reduced to the proportion of time infants spend in negative and positive affect states (Braungart-Rieker et al., 2014). We hypothesize that compared to infants born to women in the active control condition, infants born to mothers in the treatment condition will show more positive affect over time, at 3 and 12 months of age. Further, we hypothesize that infant affect at 12 months will be indirectly predicted by mothers' improvement as a result of treatment at 3 months. Higher scores indicate better outcomes."},{"outcome_type":"primary","measure":"Infant Regulation at 12 months of age","time_frame":"12-months","description":"At the 3 month and 12 month postpartum assessments, mother-infant dyads will participate in the Still-Face Paradigm (Tronick et al., 1978). Infant affect, which includes a combination of vocal and facial reactions, will be rated on a second-by-second basis across all three episodes of the SFP and free play. A 7 point Likert scale ranging from a -3 (screaming) to +3 (laughing intensely) will be used. Affect data are reduced to the proportion of time infants spend in negative and positive affect states (Braungart-Rieker et al., 2014). We hypothesize that compared to infants born to women in the active control condition, infants born to mothers in the treatment condition will show more positive affect over time, at 3 and 12 months of age. Further, we hypothesize that infant affect at 12 months will be indirectly predicted by mothers' improvement as a result of treatment at 3 months. Higher scores indicate better outcomes."},{"outcome_type":"secondary","measure":"Change in social support from baseline to posttreatment","time_frame":"posttreatment","description":"Women's sources of maternal support will be assessed with the Lubben Social Network Scale-Revised(Lubben & Gironda, 2003), which examines the level of perceived support from family networks and friendship networks. We hypothesize that compared to women in the active control condition, that women in the treatment condition will have higher social support over time. Further, we hypothesize that social support will mediate the relationship between treatment and women's mental health, revictimization, resilience, and sensitive parenting. Total scores range from 0 to 90. Higher scores indicate better outcomes."},{"outcome_type":"secondary","measure":"Change in social support from baseline to 3-months postpartum","time_frame":"3-months postpartum","description":"Women's sources of maternal support will be assessed with the Lubben Social Network Scale-Revised(Lubben & Gironda, 2003), which examines the level of perceived support from family networks and friendship networks. We hypothesize that compared to women in the active control condition, that women in the treatment condition will have higher social support over time. Further, we hypothesize that social support will mediate the relationship between treatment and women's mental health, revictimization, resilience, and sensitive parenting. Total scores range from 0 to 90. Higher scores indicate better outcomes."},{"outcome_type":"secondary","measure":"Change in social support from baseline to 12-months postpartum","time_frame":"12-months postpartum","description":"Women's sources of maternal support will be assessed with the Lubben Social Network Scale-Revised(Lubben & Gironda, 2003), which examines the level of perceived support from family networks and friendship networks. We hypothesize that compared to women in the active control condition, that women in the treatment condition will have higher social support over time. Further, we hypothesize that social support will mediate the relationship between treatment and women's mental health, revictimization, resilience, and sensitive parenting. Total scores range from 0 to 90. Higher scores indicate better outcomes."},{"outcome_type":"secondary","measure":"Change in empowerment from baseline to posttreatment","time_frame":"posttreatment","description":"The Personal Progress Scale-Revised (Johnson, Worrell, & Chandler, 2005) will be used to examine women's attitudes and behaviors associated with increased empowerment and well-being. We hypothesize that compared to women in the active control condition, that women in the treatment condition will have higher empowerment over time. Further, we hypothesize that empowerment will mediate the relationship between treatment and women's mental health, revictimization, resilience, and sensitive parenting. Scores range from 0 to 196; higher scores indicated better outcomes."},{"outcome_type":"secondary","measure":"Change in empowerment from baseline to 3-months postpartum","time_frame":"3-months postpartum","description":"The Personal Progress Scale-Revised (Johnson, Worrell, & Chandler, 2005) will be used to examine women's attitudes and behaviors associated with increased empowerment and well-being. We hypothesize that compared to women in the active control condition, that women in the treatment condition will have higher empowerment over time. Further, we hypothesize that empowerment will mediate the relationship between treatment and women's mental health, revictimization, resilience, and sensitive parenting. Scores range from 0 to 196; higher scores indicated better outcomes."},{"outcome_type":"secondary","measure":"Change in empowerment from baseline to 12-months postpartum","time_frame":"12-months postpartum","description":"The Personal Progress Scale-Revised (Johnson, Worrell, & Chandler, 2005) will be used to examine women's attitudes and behaviors associated with increased empowerment and well-being. We hypothesize that compared to women in the active control condition, that women in the treatment condition will have higher empowerment over time. Further, we hypothesize that empowerment will mediate the relationship between treatment and women's mental health, revictimization, resilience, and sensitive parenting. Scores range from 0 to 196; higher scores indicated better outcomes."}]}
{"nct_id":"NCT04150094","start_date":"2019-07-10","phase":"N/A","enrollment":42,"brief_title":"Intravaginal Vibratory Stimulus and Pelvic Floor Muscle Training","official_title":"Intravaginal Vibratory Stimulus and Pelvic Floor Muscle Training to Treat Female Urinary Incontinence: a Randomized Clinical Trial","primary_completion_date":"2021-12-20","study_type":"Interventional","rec_status":"Suspended","completion_date":"2021-12-20","last_update":"2021-09-09","description":"This is a randomized blinded trial with non-probabilistic sampling for convenience. Our goal is to compare PFMT with intravaginal vibratory stimulus versus PFMT alone on the treatment of female urinary incontinence.","other_id":"2018-0354","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Women with urinary incontinence;\r\n\r\n          -  Know how to perform a voluntary pelvic floor muscle contraction;\r\n\r\n          -  Have not undergone pelvic floor muscle training in the last 6 months;\r\n\r\n          -  Understand the instruments used in research.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Latex allergy;\r\n\r\n          -  Neurological diseases;\r\n\r\n          -  Pelvic organ prolapse > grade 2;\r\n\r\n          -  Pain during vaginal palpation and / or introduction of the vaginal probe;\r\n\r\n          -  Vaginal atrophy;\r\n      ","sponsor":"Hospital de Clinicas de Porto Alegre","sponsor_type":"Other","conditions":"Urinary Incontinence","interventions":[{"intervention_type":"Other","name":"Other: Pelvic floor muscle training (PFMT)","description":"Participants will be firstly evaluated and orientated about pelvic floor muscles and pelvic floor muscle training. They will be clarified about the role of pelvic floor muscles in continence mechanisms and will be orientated to perform 8 weeks of PFMT without stimulus, coming once a week to a session supervised by physiotherapist and will be encouraged to perform the exercises at home during the other week days."},{"intervention_type":"Other","name":"Other: Pelvic floor muscle training + intravaginal vibratory stimulus","description":"Participants will be firstly evaluated and orientated about pelvic floor muscles and pelvic floor muscle training. They will be clarified about the role of pelvic floor muscles in continence mechanisms and will be orientated to perform 8 weeks of PFMT with intravaginal vibratory stimulus. They will need to come once a week to a session supervised by physiotherapist to use the vibration device and will be encouraged to perform the exercises at home during the other week days."}],"outcomes":[{"outcome_type":"primary","measure":"Change in urinary incontinence","time_frame":"8 weeks","description":"We will measure it using the \"International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) - Portuguese version\", pre and post treatment, to assess if there are any changes in bladder control after the protocols. It consists of 3 scored items which evaluate the frequency, volume of leakage and overall impact of incontinence. The overall score ranges from 0 to 21, with greater values indicating increased severity. Klovning et al (2009) says that ICIQ-SF may be divided into the following four severity categories of UI: slight (1-5), moderate (6-12), severe (13-18) and very severe (19-21). Lim et al (2019) suggested that for women undergoing nonsurgical treatments for incontinence, reductions of 4 points in ICIQ-UI SF are perceived as clinically meaningful."},{"outcome_type":"secondary","measure":"Impact in quality of life","time_frame":"8 weeks","description":"We are using the \"International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) - Portuguese version\", which asks about overall impact of UI in quality of life by a scale from 0-10 of how much these symptoms bothered the patient's life. We are going to say the participant \"imagine that 0 is if urinary leakage doesn't bother you at all and 10 is as much as this can disrupt your life\". There are other questions in this questionnaire according to the severity of the UI symptoms. Each answer has a punctuation and the total score could range between 0 and 21. The higher, the worse is the severity of UI and the impact on the participant's quality of life. The ICIQ is highly recommended (Grade A) for the basic evaluation of the patient's perspective of urinary incontinence (Abrams et al, 2010)."}]}
{"nct_id":"NCT04013191","start_date":"2019-07-09","phase":"Phase 1","enrollment":28,"brief_title":"A Study to Test the Safety and Tolerability of Single and Multiple Doses of Padsevonil in Adult and Elderly Study Participants","official_title":"An Open-Label, Parallel-Group, Pharmacokinetic, Safety and Tolerability Study of Single and Multiple Oral Administrations of Padsevonil in Adult and Elderly Study Participants","primary_completion_date":"2019-10-03","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-10-03","last_update":"2021-06-30","description":"The purpose of the study is to evaluate the plasma pharmacokinetic of padsevonil in adult and elderly study participants.","other_id":"UP0053","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Study participants in the adult cohort must be 18 to 64 years of age at the time of\r\n             signing the informed consent form (ICF)\r\n\r\n          -  Study participants in the elderly cohort must be 65 years of age at the time of\r\n             signing the ICF\r\n\r\n          -  Study participants who are overtly healthy as determined by medical evaluation,\r\n             including medical history, physical examination, laboratory tests, and cardiac\r\n             monitoring. In addition, elderly study participants must be considered to be in\r\n             general good physical and mental health\r\n\r\n          -  Study participants must have a body weight of at least 50 kg for males and 45 kg for\r\n             females, and a body mass index within the range of 18 to 32 kg/m2 (inclusive)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Study participant has a current or past psychiatric condition that, in the opinion of\r\n             the Investigator, could compromise the study participant's safety or ability to\r\n             participate in this study, or a history of schizophrenia or other psychotic disorder,\r\n             bipolar disorder, or severe unipolar depression. The presence of potential psychiatric\r\n             exclusion criteria will be determined based on the psychiatric history collected at\r\n             Screening\r\n\r\n          -  Study participant has history or presence of cardiovascular, respiratory, hepatic,\r\n             renal, gastrointestinal, endocrinological, hematological, or neurological disorders\r\n             capable of significantly altering the absorption, metabolism, or elimination of drugs;\r\n             constituting a risk when taking the study intervention; or interfering with the\r\n             interpretation of data\r\n\r\n          -  Study participant has a known hypersensitivity to any components of the study\r\n             medication as stated in this protocol\r\n\r\n          -  Subject has a history of unexplained syncope or a family history of sudden death due\r\n             to long QT syndrome\r\n\r\n          -  Study participant has abnormal blood pressure\r\n\r\n          -  Study participant has had lymphoma, leukemia, or any malignancy within the past 5\r\n             years, except for basal cell or squamous epithelial carcinomas of the skin that have\r\n             been resected with no evidence of metastatic disease for 3 years\r\n\r\n          -  Study participant has a lifetime history of suicide attempt, or has had suicidal\r\n             ideation in the past 6 months as indicated by a positive response (\"Yes\") to either\r\n             Question 4 or Question 5 of the \"Screening/Baseline\" version of the Columbia-Suicide\r\n             Severity Rating Scale (C-SSRS) at Screening\r\n\r\n          -  Study participant has past or intended use of over-the-counter or prescription\r\n             medication, including herbal medications within 2 weeks or 5 half-lives prior to\r\n             dosing\r\n\r\n          -  The study participant has used hepatic enzyme-inducing drugs within 2 months prior to\r\n             dosing\r\n\r\n          -  Study participant has previously received padsevonil (PSL) in this or another study\r\n\r\n          -  Study participant has alanine aminotransferase (ALT), aspartate aminotransferase\r\n             (AST), or alkaline phosphatase (ALP) >1.0x upper limit of normal (ULN)\r\n\r\n          -  Study participant has bilirubin >1.0xULN (isolated bilirubin >1.0xULN is acceptable if\r\n             bilirubin is fractionated and direct bilirubin <35%)\r\n\r\n          -  Study participant has current or chronic history of liver disease or known hepatic or\r\n             biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic\r\n             gallstones)\r\n\r\n          -  Study participant has any clinically relevant electrocardiogram (ECG) finding at\r\n             Screening or at Baseline. Study participant has an abnormality in the 12-lead ECG\r\n             that, in the opinion of the Investigator, increases the risks associated with\r\n             participating in the study. In addition, any study participant with any of the\r\n             following findings will be excluded: (a) QT interval corrected for heart rate using\r\n             Bazett's formula (QTcB) or Fridericia's formula (QTcF) >450 ms in study participants\r\n             in 2 of 3 ECG recordings; (b) other conduction abnormalities (defined as PR interval\r\n             220 ms); (c) irregular rhythms other than sinus arrhythmia or occasional, rare\r\n             supraventricular or rare ventricular ectopic beats. In case of an out of range result,\r\n             1 repeat will be allowed. If out of range again, the study participant cannot be\r\n             included\r\n      ","sponsor":"UCB Biopharma S.P.R.L.","sponsor_type":"Industry","conditions":"Elderly Study Participants|Adult Study Participants","interventions":[{"intervention_type":"Drug","name":"Drug: Padsevonil","description":"Padsevonil will be administered in predefined dosages."}],"outcomes":[{"outcome_type":"primary","measure":"The Maximum Plasma Concentration (Cmax) of a Single Dose Padsevonil (PSL)","time_frame":"Plasma samples were taken predose on Day 1 and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours postdose","description":"Cmax was measured in nanograms per milliliter (ng/mL)."},{"outcome_type":"primary","measure":"The Area Under the Curve From 0 to t (AUC0-t) of a Single Dose Padsevonil (PSL)","time_frame":"Plasma samples were taken predose on Day 1 and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours postdose","description":"AUC0-t: area under the plasma concentration-time curve from time 0 to the last quantifiable concentration. It was measured in hours times nanograms per milliliter (h*ng/mL)."},{"outcome_type":"primary","measure":"The Area Under the Curve (AUC) of a Single Dose Padsevonil (PSL)","time_frame":"Plasma samples were taken predose on Day 1 and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8, 12, 24, 48 and 72 hours postdose","description":"AUC was measured in hours times nanograms per milliliter (h*ng/mL)."},{"outcome_type":"primary","measure":"The Maximum Plasma Concentration at Steady-state (Cmax, ss) of Multiple Doses Padsevonil (PSL)","time_frame":"Plasma samples were taken predose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 12 hours on Day 13","description":"Cmax, ss was measured in nanograms per milliliter (ng/mL)."},{"outcome_type":"primary","measure":"The Area Under the Curve (AUCtau) Over a Dosing Interval of Multiple Doses Padsevonil (PSL)","time_frame":"Plasma samples were taken predose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 12 hours on Day 13","description":"AUCtau was measured in hours times nanograms per milliliter (h*ng/mL)."},{"outcome_type":"secondary","measure":"The Amount of Padsevonil (PSL) Excreted in Urine","time_frame":"Urine samples were taken on Day 1, Day 2, Day 3, Day 4 and Day 13","description":"Samples were taken to assess the amount of padsevonil that was excreted in urine. Ae,ss refers to cumulative amount of PSL excreted in the urine at steady state."},{"outcome_type":"secondary","measure":"The Ratio of Padsevonil (PSL) to Its Metabolites Excreted in Urine","time_frame":"Urine samples were taken on Day 1, Day 2, Day 3, Day 4 and Day 13","description":"Samples were taken to assess the metabolic ratio of padsevonil that was excreted in urine. MRAe was defined as the metabolic ratio of PSL to its metabolites for cumulative amount of PSL metabolites excreted in the urine. ss refers to steady state."},{"outcome_type":"secondary","measure":"Number of Participants With Treatment-emergent Adverse Events","time_frame":"From Baseline until End-of-Treatment visit (up to Day 22)","description":"An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication."},{"outcome_type":"secondary","measure":"Number of Participants With Serious Adverse Events","time_frame":"From Baseline until End-of-Treatment visit (up to Day 22)","description":"A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:\r\nResults in death\r\nIs life-threatening\r\nRequires in patient hospitalization or prolongation of existing hospitalization\r\nIs a congenital anomaly or birth defect\r\nIs an infection that requires treatment parenteral antibiotics\r\nOther important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above"},{"outcome_type":"secondary","measure":"Number of Participants With Treatment-emergent Adverse Events Leading to Discontinuation of the Study","time_frame":"From Baseline until End-of-Treatment visit (up to Day 22)","description":"An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product."}]}
{"nct_id":"NCT04470245","start_date":"2019-07-08","phase":"N/A","enrollment":30,"brief_title":"Cubital Tunnel Syndrome and Diffusion MRI: A Proof of Concept Study","official_title":"Cubital Tunnel Syndrome and Diffusion Tensor Magnetic Resonance Imaging: A Proof of Concept Study","primary_completion_date":"2020-11-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2020-11-01","last_update":"2020-07-14","description":"Cubital Tunnel Syndrome (CTS) results from compression of the ulnar nerve at the elbow (colloquially termed the \"funny bone\"). CTS affects up to 6% of the population and 6000 patients undergo surgery annually in the UK. Surgery is the only proven treatment for CTS, although up to 30% of patients do not improve. Therefore, there is a pressing need to develop a reliable test to diagnose CTS to improve the selection of patients for surgery. New techniques in the field of magnetic resonance imaging (MRI) allow the visualisation of nerve structure and function. Diffusion tensor MRI, also known as diffusion tensor imaging (DTI), can diagnose CTS with superior diagnostic accuracy and could enable the reliable diagnostic of CTS, improving the selection of patients for surgery. The study will include healthy volunteers (to refine the scanning sequence) and patients undergoing surgery for CTS. Patients will be scanned preoperatively and postoperatively using cutting-edge diffusion MRI techniques. The primary outcome will be change in the MRI-derived diffusion metrics following surgery. Secondary outcomes will consider how MRI relates to patient-reported outcomes and conventional clinical tests (ultrasound and nerve conduction studies). Leeds is the ideal location for this research because a) Leeds institutions are the most highly cited organisations in musculoskeletal research, b) Leeds houses the National Centre for Hyperpolarized MRI and a state-of-the-art MRI scanner, and c) Leeds is an internationally recognised centre of excellence for complex upper limb surgery.","other_id":"PL19/122843","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adults (over 18 years of age) undergoing surgical decompression of the ulnar nerve at\r\n             the elbow for cubital tunnel syndrome.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Unable to get into the MRI scanner due to habitus or claustrophobia\r\n\r\n          -  Unable to lie still due to any cause (eg. athetoid movements, dystonias, chorea, etc)\r\n\r\n          -  Intraocular or intracranial metallic foreign bodies\r\n\r\n          -  Active implants (eg. pacemakers, implantable cardiac defibrillators, nerve\r\n             stimulators, etc) which are not MRI safe or conditional.\r\n\r\n          -  Pregnancy - whilst there are no known adverse effects of MRI16-18 to the mother or\r\n             fetus, MRI is generally avoided in pregnancy due to the acoustic trauma19 and\r\n             inductive heating generated by alternating magnetic fields.\r\n\r\n          -  Any metallic implants in the elbow\r\n      ","sponsor":"The Leeds Teaching Hospitals NHS Trust","sponsor_type":"Other","conditions":"Cubital Tunnel Syndrome","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: magnetic resonance imaging (MRI)","description":"Our study will include healthy volunteers (to refine the scanning sequence) and patients undergoing surgery for CTS. Patients will be scanned before and after their operation using cutting-edge diffusion MRI techniques."}],"outcomes":[{"outcome_type":"primary","measure":"The question is whether the MRI diffusion metrics of the ulnar nerve in patients with the cubital tunnel","time_frame":"60 minutes","description":"change following surgical decompression."}]}
{"nct_id":"NCT03659422","start_date":"2019-07-01","phase":"N/A","enrollment":0,"brief_title":"Dietary Approach to Improving Quality of Life in Amyotrophic Lateral Sclerosis","official_title":"Dietary Approach to Improving QoL in ALS","primary_completion_date":"2021-07-01","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2021-07-01","last_update":"2019-06-14","description":"We have had reports of an individual who utilized a modified Paleolithic diet and vitamin/ supplement program as part of his approach to managing ALS related symptoms. This individual has experienced stability in his ALS functional rating score and stable to improving strength over an 18 month period. There are also anecdotal reports of ALS patients who have utilized a dietary approach based on a Paleolithic eating plan of improved function. This is a safety study. We will be assessing if patients can implement the proposed modified Paleolithic diet (Wahls Elimination), if lean muscle mass is maintained on the study diet, and what changes occur in the ALS functional symptoms and quality of life.","other_id":"201802746","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Diagnosis of clinically possible, clinically probable (with or without laboratory\r\n             support), or clinically definite ALS (using the revised El Escorial Criteria)\r\n\r\n          2. Ability to prepare, or have prepared for them, home-cooked meals\r\n\r\n          3. Age between 18 and 80 years\r\n\r\n          4. Followed by ALS clinic at the University of Iowa\r\n\r\n          5. Willingness to adopt the study diet\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Clinically significant liver, kidney, or heart disease\r\n\r\n          2. Taking insulin or Coumadin\r\n\r\n          3. Ventilator dependence\r\n\r\n          4. Psychiatric disorder making dietary compliance difficult (e.g. schizophrenia)\r\n\r\n          5. Unwillingness to have blood specimens collected\r\n\r\n          6. Dysphagia present\r\n\r\n          7. Greater than two years since onset of ALS symptoms\r\n      ","sponsor":"Terry L. Wahls","sponsor_type":"Other","conditions":"Diet Modification|Amyotrophic Lateral Sclerosis","interventions":[{"intervention_type":"Other","name":"Other: Modified Paleolithic diet","description":"The diet eliminates legumes, grains and nightshades (as opposed to the Paleolithic diet) and is higher in vegetable and fruit intake and in omega-3 fatty rich foods."}],"outcomes":[{"outcome_type":"primary","measure":"Change in total body weight from baseline over 12 weeks.","time_frame":"12 weeks","description":"body weight (kilograms)"},{"outcome_type":"primary","measure":"Change in Body Mass Index from baseline over 12 weeks.","time_frame":"12 weeks","description":"body weight (in kilograms) divided by height square (in meters)"},{"outcome_type":"primary","measure":"change in fat mass (in kilograms) from baseline over 12 weeks","time_frame":"12 weeks","description":"Bio-electrical impedance measurement of body composition"},{"outcome_type":"primary","measure":"change in fat-free mass (in kilograms) from baseline over 12 weeks","time_frame":"12 weeks","description":"Bio-electrical impedance measurement of body composition"},{"outcome_type":"secondary","measure":"change in motor function over 12 weeks","time_frame":"12 weeks","description":"Grip strength"},{"outcome_type":"secondary","measure":"change in breathing function over 12 weeks","time_frame":"12 weeks","description":"Forced Expiratory Volume"},{"outcome_type":"secondary","measure":"Change in fatigue level","time_frame":"12 weeks","description":"Fatigue Severity Scale is used. scale has 9 questions, each could range from 1 to 7. Sum responses and divide by number of items for scale score. Higher score indicates more disability."}]}
{"nct_id":"NCT03442374","start_date":"2019-07-01","phase":"N/A","enrollment":40,"brief_title":"Lumbar Spine Muscle Degeneration Inhibits Rehabilitation-Induced Muscle Recovery","official_title":"Lumbar Spine Muscle Degeneration Inhibits Rehabilitation-Induced Muscle","primary_completion_date":"2022-06-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-06-01","last_update":"2021-04-06","description":"Low back pain (LBP) is a complex condition that affects 65-85% of the population, and is the leading musculoskeletal condition contributing to disability in the United States. Disc herniation is the most common injury and 75% of individuals undergoing surgical and rehabilitative interventions for this condition experience suboptimal or poor outcomes. These patients demonstrate disability and deficits in functional capacity, including strength and endurance of the lumbar musculature. Muscle-specific changes in individuals with LBP include altered muscle volume, fatty infiltration and fibrosis, and fiber area and type. Importantly, these changes are insensitive to rehabilitation in patients with continued chronic or recurrent symptoms. While normal disuse-related atrophy in the presence of LBP is expected, more severe or chronic pathology, such as inflammation and fiber damage, may be inducing irreversible fiber degeneration and fatty/fibrotic tissue changes that impair muscle function and recovery. While the structural and adaptive capacities of healthy muscle are well understood, muscle recovery in the presence of pathology is less clear. To address this gap in knowledge, the purpose of this project is to compare structural, physiological, and adaptive responses of muscle in the presence of acute and chronic lumbar spine pathology. The central hypothesis is that chronic injury results in a state of muscle inflammation, atrophy, fibrosis, and muscle degeneration that is not responsive to exercise. The Investigators will identify which patients respond to exercise by examining muscle hypertrophic, fibrotic, inflammatory, and adipogenic gene expression profiles. Patients will be followed for six months post-operatively to measure muscle recovery and strength.","other_id":"HD088437","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"Single","intervention_model_description":"Stratified by fatty infiltration severity (n=20/group x 2 groups + non exercise controls n=20)","sampling_method":"","gender":"All","minimum_age":21,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Spine pathologies requiring un-instrumented surgery (i.e. laminectomy,\r\n             laminoforaminotomy, or discectomy).\r\n\r\n          -  Age 21-85 years of age.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of lumbar spine surgery.\r\n\r\n          -  Patients requiring placement of instrumentation as part of the surgical procedure\r\n             (i.e. fusion).\r\n\r\n          -  Diabetes.\r\n\r\n          -  Neuromuscular diseases.\r\n      ","sponsor":"University of California, San Diego","sponsor_type":"Other","conditions":"Disc Degeneration|Low Back Pain","interventions":[{"intervention_type":"Other","name":"Other: Exercise","description":"The exercise protocol consists of 1 set of 20 repetitions (range 15-25 reps) at a rate of 5 seconds/repetitions with a starting weight of 60-80% of their computerized strength score. Patients will be instructed to target an exertion level of 7/10 on the Borg Rate of Perceived Exertion (RPE) scale within their available passive ROM range into flexion-extension"}],"outcomes":[{"outcome_type":"secondary","measure":"TGFB1 Protein abundance (ug/mg)","time_frame":"6 hours after a single exercise bout","description":"TGFB1 Protein abundance"},{"outcome_type":"secondary","measure":"MMP1 Protein abundance (ug/mg)","time_frame":"6 hours after a single exercise bout","description":"MMP1 Protein abundance"},{"outcome_type":"secondary","measure":"MMP3 gene expression (delta CT/delta CT)","time_frame":"6 hours after a single exercise bout","description":"MMP3 gene expression"},{"outcome_type":"secondary","measure":"MMP9 gene expression (delta CT/delta CT)","time_frame":"6 hours after a single exercise bout","description":"MMP9 gene expression"},{"outcome_type":"secondary","measure":"CEBPA gene expression (delta CT/delta CT)","time_frame":"6 hours after a single exercise bout","description":"CEBPA gene expression"},{"outcome_type":"secondary","measure":"FABP4 gene expression (delta CT/delta CT)","time_frame":"6 hours after a single exercise bout","description":"FABP4 gene expression"},{"outcome_type":"secondary","measure":"PPARG gene expression (delta CT/delta CT)","time_frame":"6 hours after a single exercise bout","description":"PPARG gene expression"},{"outcome_type":"secondary","measure":"PPARD gene expression (delta CT/delta CT)","time_frame":"6 hours after a single exercise bout","description":"PPARD gene expression"},{"outcome_type":"secondary","measure":"LEP gene expression (delta CT/delta CT)","time_frame":"6 hours after a single exercise bout","description":"LEP gene expression"},{"outcome_type":"primary","measure":"Change in Multifidus Muscle Fatty Infiltration","time_frame":"6 months","description":"(% fat at 6 months - % fat at baseline / % fat at baseline)"},{"outcome_type":"secondary","measure":"Change in Oswestry Disability Index (ODI)","time_frame":"6 Months","description":"Disability Questionnaire (10 questions, % scale is sum of 10 questions/50, higher score is worse), 6 months - baseline"},{"outcome_type":"secondary","measure":"Change in Fear Avoidance Beliefs Questionnaire (FABQ)","time_frame":"6 months","description":"Fear Avoidance Behaviors (sumo 16 items, 0-64 scale, higher score is worse), 6 months- baseline"},{"outcome_type":"secondary","measure":"Change in Pain Catastrophizing Scale (PCS)","time_frame":"6 months","description":"Pain behaviors questionnaire (sum of 13 items, 0-52 scale, higher score is worse), 6 months - baseline"},{"outcome_type":"secondary","measure":"Change in Activated Muscle Volume (%)","time_frame":"After exercise (within 5 minutes)","description":"(% muscle activation after exercise - % muscle activation at baseline / % muscle activation at baseline)"},{"outcome_type":"secondary","measure":"Change in Pain (VAS)","time_frame":"6 months","description":"Visual Analog Scale (0-100 mm scale), 6 months - baseline"},{"outcome_type":"secondary","measure":"Change in Strength","time_frame":"6 months","description":"MedEx dynamometer, Back Extensor Strength (Nm), 6 months - baseline"},{"outcome_type":"secondary","measure":"MYHC3 gene expression (delta CT/delta CT)","time_frame":"6 hours after a single exercise bout","description":"Embryonic myosin heavy chain gene expression"},{"outcome_type":"secondary","measure":"MHY3 protein abundance (ug/mg)","time_frame":"6 hours after a single exercise bout","description":"Embryonic myosin heavy chain protein abundance"},{"outcome_type":"secondary","measure":"MYOG gene expression (delta CT/delta CT)","time_frame":"6 hours after a single exercise bout","description":"Myogenin gene expression"},{"outcome_type":"secondary","measure":"MYOG protein abundance (ug/mg)","time_frame":"6 hours after a single exercise bout","description":"Myogenin protein abundance"},{"outcome_type":"secondary","measure":"PAX7 gene expression (delta CT/delta CT)","time_frame":"6 hours after a single exercise bout","description":"PAX7 gene expression"},{"outcome_type":"secondary","measure":"PAX7 gene expression (ug/mg)","time_frame":"6 hours after a single exercise bout","description":"PAX7 protein abundance"},{"outcome_type":"secondary","measure":"ANKRD2 gene expression (delta CT/delta CT)","time_frame":"6 hours after a single exercise bout","description":"ANKRD2 gene expression"},{"outcome_type":"secondary","measure":"ANKRD2 protein abundance (ug/mg)","time_frame":"6 hours after a single exercise bout","description":"ANKRD2 protein abundance"},{"outcome_type":"secondary","measure":"MTOR gene expression (delta CT/delta CT)","time_frame":"6 hours after a single exercise bout","description":"MTOR gene expression"},{"outcome_type":"secondary","measure":"MTOR protein abundance (ug/mg)","time_frame":"6 hours after a single exercise bout","description":"MTOR protein abundance"},{"outcome_type":"secondary","measure":"COL1A1 gene expression (delta CT/delta CT)","time_frame":"6 hours after a single exercise bout","description":"COL1A1 gene expression"},{"outcome_type":"secondary","measure":"COL3A1 gene expression (delta CT/delta CT)","time_frame":"6 hours after a single exercise bout","description":"COL3A1 gene expression"},{"outcome_type":"secondary","measure":"COL9A1 gene expression (delta CT/delta CT)","time_frame":"6 hours after a single exercise bout","description":"COL9A1 gene expression"},{"outcome_type":"secondary","measure":"LOX gene expression (delta CT/delta CT)","time_frame":"6 hours after a single exercise bout","description":"LOX gene expression"},{"outcome_type":"secondary","measure":"CTGF gene expression (delta CT/delta CT)","time_frame":"6 hours after a single exercise bout","description":"CTGF gene expression"},{"outcome_type":"secondary","measure":"TGFB1 gene expression (delta CT/delta CT)","time_frame":"6 hours after a single exercise bout","description":"TGFB1 gene expression"},{"outcome_type":"secondary","measure":"MMP1 gene expression (delta CT/delta CT)","time_frame":"6 hours after a single exercise bout","description":"MMP1 gene expression"},{"outcome_type":"secondary","measure":"ADIPOQ gene expression (delta CT/delta CT)","time_frame":"6 hours after a single exercise bout","description":"ADIPOQ gene expression"},{"outcome_type":"secondary","measure":"CASP1 gene expression (delta CT/delta CT)","time_frame":"6 hours after a single exercise bout","description":"CASP1 gene expression"},{"outcome_type":"secondary","measure":"CASP3 gene expression (delta CT/delta CT)","time_frame":"6 hours after a single exercise bout","description":"CASP3 gene expression"},{"outcome_type":"secondary","measure":"TNFa gene expression (delta CT/delta CT)","time_frame":"6 hours after a single exercise bout","description":"TNFa gene expression"},{"outcome_type":"secondary","measure":"IL10 gene expression (delta CT/delta CT)","time_frame":"6 hours after a single exercise bout","description":"IL10 gene expression"},{"outcome_type":"secondary","measure":"IL6 gene expression (delta CT/delta CT)","time_frame":"6 hours after a single exercise bout","description":"IL6 gene expression"},{"outcome_type":"secondary","measure":"IL1B gene expression (delta CT/delta CT)","time_frame":"6 hours after a single exercise bout","description":"IL1B gene expression"},{"outcome_type":"secondary","measure":"COL1A1 Protein abundance (ug/mg)","time_frame":"6 hours after a single exercise bout","description":"COL1A1 Protein abundance"},{"outcome_type":"secondary","measure":"COL3A1 Protein abundance (ug/mg)","time_frame":"6 hours after a single exercise bout","description":"COL3A1 Protein abundance"},{"outcome_type":"secondary","measure":"COL9A1 Protein abundance (ug/mg)","time_frame":"6 hours after a single exercise bout","description":"COL9A1 Protein abundance"},{"outcome_type":"secondary","measure":"LOX Protein abundance (ug/mg)","time_frame":"6 hours after a single exercise bout","description":"LOX Protein abundance"},{"outcome_type":"secondary","measure":"CTGF Protein abundance (ug/mg)","time_frame":"6 hours after a single exercise bout","description":"CTGF Protein abundance"},{"outcome_type":"secondary","measure":"MMP3 Protein abundance (ug/mg)","time_frame":"6 hours after a single exercise bout","description":"MMP3 Protein abundance"},{"outcome_type":"secondary","measure":"MMP9 Protein abundance (ug/mg)","time_frame":"6 hours after a single exercise bout","description":"MMP9 Protein abundance"},{"outcome_type":"secondary","measure":"CEBPA Protein abundance (ug/mg)","time_frame":"6 hours after a single exercise bout","description":"CEBPA Protein abundance"},{"outcome_type":"secondary","measure":"FABP4 Protein abundance (ug/mg)","time_frame":"6 hours after a single exercise bout","description":"FABP4 Protein abundance"},{"outcome_type":"secondary","measure":"PPARG Protein abundance (ug/mg)","time_frame":"6 hours after a single exercise bout","description":"PPARG Protein abundance"},{"outcome_type":"secondary","measure":"PPARD Protein abundance (ug/mg)","time_frame":"6 hours after a single exercise bout","description":"PPARD Protein abundance"},{"outcome_type":"secondary","measure":"LEP Protein abundance (ug/mg)","time_frame":"6 hours after a single exercise bout","description":"LEP Protein abundance"},{"outcome_type":"secondary","measure":"ADIPOQ Protein abundance (ug/mg)","time_frame":"6 hours after a single exercise bout","description":"ADIPOQ Protein abundance"},{"outcome_type":"secondary","measure":"CASP1 Protein abundance (ug/mg)","time_frame":"6 hours after a single exercise bout","description":"CASP1 Protein abundance"},{"outcome_type":"secondary","measure":"CASP3 Protein abundance (ug/mg)","time_frame":"6 hours after a single exercise bout","description":"CASP3 Protein abundance"},{"outcome_type":"secondary","measure":"TNFa Protein abundance (ug/mg)","time_frame":"6 hours after a single exercise bout","description":"TNFa Protein abundance"},{"outcome_type":"secondary","measure":"IL10 Protein abundance (ug/mg)","time_frame":"6 hours after a single exercise bout","description":"IL10 Protein abundance"},{"outcome_type":"secondary","measure":"IL6 Protein abundance (ug/mg)","time_frame":"6 hours after a single exercise bout","description":"IL6 Protein abundance"},{"outcome_type":"secondary","measure":"IL1B Protein abundance (ug/mg)","time_frame":"6 hours after a single exercise bout","description":"IL1B Protein abundance"},{"outcome_type":"secondary","measure":"Change in Multifidus muscle volume (%)","time_frame":"baseline","description":"Multifidus muscle volume (cc), (6 months - baseline/baseline)"}]}
{"nct_id":"NCT04096066","start_date":"2019-07-01","phase":"Phase 3","enrollment":340,"brief_title":"A Trial That Compare Two Treatments in Newly Diagnosed Myeloma Patients Not Eligible for Transplant","official_title":"Carfilzomib - Lenalidmide - Dexamethasone (KRd) Versus Lenalidomi - Dexamethasone (Rd) in Newly Diagnosed Myeloma Patients Not Eligible for Autologous Stem Cell Transplantation: a Randomized Phas III Trial","primary_completion_date":"2024-07-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2024-07-01","last_update":"2021-01-11","description":"The combination of lenalidomide plus low-dose dexamethasone (Rd) is considered the new standard for elderly newly diagnosed multiple myeloma (NDMM) patients. The combination carfilzomib plus lenalidomide-dexamethasone (KRd) in relapsed-refractory MM patients improved the progression-free survival (PFS) of approximately 1 year compared to standard Rd treatment. In a small phase 2 trial (23 pts) the KRd combination in elderly NDMM pts showed a complete response (CR) rate of 79% and a PFS at 3 years of 80%. Cardiovascular adverse events are the most limiting toxicities, especially in elderly patients.","other_id":"EMN20","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Newly diagnosed symptomatic MM based on either standard CRAB criteria (at least 10% of\r\n             clonal bone marrow plasma cells plus CRAB defined as the onset of any of the following\r\n             clinical symptoms: hypercalcemia, renal failure, anemia and bone lesions) or at least\r\n             10% of bone marrow plasma cells plus the presence of at least one of the following\r\n             biomarkers of malignancy:\r\n\r\n               -  60% or greater clonal plasma cells on bone marrow examination;\r\n\r\n               -  Serum involved/uninvolved free light chain (FLC) ratio of 100 or greater;\r\n\r\n               -  More than one focal lesion on magnetic resonance imaging (MRI) that is at least 5\r\n                  mm or greater in size.\r\n\r\n          -  Patient not eligible for ASCT (age  65 years or abnormal cardiac, pulmonary and liver\r\n             function).\r\n\r\n          -  Patient defined as fit or intermediate according to the IMWG (International Myeloma\r\n             Working Group) frailty score\r\n\r\n          -  Patient has given voluntary written informed consent.\r\n\r\n          -  Patient is able to be compliant with hospital visits and procedures required per\r\n             protocol.\r\n\r\n          -  Patient agrees to use acceptable methods for contraception.\r\n\r\n          -  Patient has measurable disease according to IMWG criteria.\r\n\r\n          -  Patient has ECOG (Eastern Cooperative Oncology Group) performance status < 3.\r\n\r\n          -  Pre-treatment clinical laboratory values within 30 days before randomization:\r\n\r\n               -  Platelet count 50 x 109/L (30 x 109 /L if myeloma involvement in the bone\r\n                  marrow is > 50%)\r\n\r\n               -  Absolute neutrophil count (ANC)  1 x 109/L without the use of growth factors\r\n\r\n               -  Corrected serum calcium 14 mg/dL (3.5 mmol/L)\r\n\r\n               -  Alanine transaminase (ALT):  3 x the ULN\r\n\r\n               -  Total bilirubin:  2 x the ULN\r\n\r\n               -  Calculated or measured creatinine clearance:  30 mL/minute.\r\n\r\n          -  LVEF 40%: 2-D transthoracic echocardiogram (ECHO) is the preferred method of\r\n             evaluation; multigated Acquisition Scan (MUGA) is acceptable if ECHO is not available\r\n\r\n          -  Pre-treatment blood pressure value < 140/90 mmHg even with adequate therapy: 24 hours\r\n             blood pressure monitoring is the preferred method of evaluation; blood pressure diary\r\n             at home for 2 weeks is acceptable.\r\n\r\n          -  Females of childbearing potential (FBCP) comply with the conditions of the Pregnancy\r\n             Prevention Plan, including confirmation that she has an adequate level of\r\n             understanding.\r\n\r\n          -  FBCP must follow the Pregnancy Prevention Plan and use a highly effective and an\r\n             additional barrier contraception method simultaneously for 4 weeks before starting\r\n             therapy, during treatment and dose interruptions and for at least 30 days after the\r\n             last dose of study drugs*\r\n\r\n          -  Males must use an effective barrier method of contraception if sexually active with\r\n             FCBP during the treatment and for at least 90 days after the last administration of\r\n             study drug/s. Male subjects must agree to refrain from sperm donation for at least 90\r\n             days after the last dose of carfilzomib.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Serious medical condition, laboratory abnormality or psychiatric illness that\r\n             prevented the subject from the screening or place the subject at unacceptable risk.\r\n\r\n          -  Patient defined as frail according to the IMWG frailty score.\r\n\r\n          -  Previous treatment with anti-myeloma therapy (does not include radiotherapy,\r\n             bisphosphonates, or a single short course of steroid < to the equivalent of\r\n             dexamethasone 40 mg/day for 4 days).\r\n\r\n          -  Pregnant or lactating females.\r\n\r\n          -  Presence of:\r\n\r\n               -  Clinical active infectious hepatitis type A, B, C or HIV\r\n\r\n               -  Acute active infection requiring antibiotics or infiltrative pulmonary disease\r\n\r\n               -  Pulmonary hypertension and interstitial lung disease\r\n\r\n               -  Uncontrolled arrhythmias or history of QT prolongation\r\n\r\n               -  Myocardial infarction or unstable angina  6 months or other clinically\r\n                  significant heart disease\r\n\r\n               -  Peripheral neuropathy or neuropathic pain grade 2 or higher, as defined by\r\n                  National Cancer Institute Common Toxicity Criteria (NCI CTC) 5.0 (Appendix A)\r\n\r\n               -  Uncontrolled hypertension defined as persistent hypertension (>140/90 mmHg)\r\n                  regardless treatment with 3 drugs, including a diuretic.\r\n\r\n          -  Contraindication to any of the required drugs or supportive treatments and\r\n             hypersensitivity to any excipient of the study drugs.\r\n\r\n          -  Known history of allergy to Captisol (a cyclodextrin derivative used to solubilize\r\n             carfilzomib).\r\n\r\n          -  Invasive malignancy within the past 3 years.\r\n\r\n          -  Administration of any experimental drug within 4 weeks prior the baseline or within 5\r\n             drug half-lives.\r\n      ","sponsor":"Fondazione EMN Italy Onlus","sponsor_type":"Other","conditions":"Multiple Myeloma|New Diagnosis Tumor","interventions":[{"intervention_type":"Drug","name":"Drug: Carfilzomib","description":"20 mg/m2 IV on day 1 of cycle 1 enhanced to 56 mg/m2 on days 8, and 15 of cycle 1;\r\n56 mg/m2 IV on days 1, 8 and 15 in cycles 2-12;\r\n56 mg/m2 IV on days 1 and 15 from cycle 13 and onwards."},{"intervention_type":"Drug","name":"Drug: Lenalidomide","description":"- 25 mg orally on days 1-21 of each cycle."},{"intervention_type":"Drug","name":"Drug: Dexamethasone","description":"- 40 mg orally on days 1, 8, 15 and 22 of each cycle. Each cycle is to be repeated every 28 days. Patients that achieve at least a VGPR within the first year of study treatment and in sustained MRD negativity (MRD negative at least at 10-5 after 1 and 2 years of therapy) will stop carfilzomib administration after 2 years and will continue with lenalidomide and dexamethasone treatment until disease progression or intolerance to the therapy. Other patients will continue carfilzomib administration until disease progression or intolerance.\r\nFor patients >75 years of age, the dose of dexamethasone is 20 mg/day on Days 1, 8, 15 and 22 of each treatment cycle."}],"outcomes":[{"outcome_type":"secondary","measure":"MRD negativity","time_frame":"5 years","description":"Correlation between MRD negativity and PFS, PFS2, TTP, TNT and OS"},{"outcome_type":"secondary","measure":"Progression-free survival 2 (PFS2)","time_frame":"5 years","description":"Time from randomization to objective tumor progression on next-line treatment or death from any cause."},{"outcome_type":"secondary","measure":"Overall survival (OS)","time_frame":"5 years","description":"Time between randomization and death. Subjects who die will be censored at time of death as an event, regardless cause of death."},{"outcome_type":"secondary","measure":"Time to next therapy (TNT)","time_frame":"5 years","description":"Time to next therapy will be measured from the date of randomization to the date of next anti-myeloma therapy. Death due to any cause before starting therapy will be considered an event."},{"outcome_type":"primary","measure":"Minimal residual disease (MRD)","time_frame":"5 years","description":"1. Minimal residual disease (MRD): unit of measure is not applicable, MRD is expressed as a pure number"},{"outcome_type":"primary","measure":"Progression-free survival (PFS)","time_frame":"5 years","description":"2. Progression-free survival (PFS): unit of measure is not applicable, PFS is expressed as a pure number"},{"outcome_type":"secondary","measure":"Rate of drug reduction or drug discontinuation","time_frame":"5 years","description":"Incidence of dose reduction and drug discontinuation in both treatment arms."},{"outcome_type":"secondary","measure":"Cardiovascular assessment","time_frame":"5 years","description":"Benefit of proper cardiovascular baseline assessment and monitoring during treatment in both treatment arms:to mitigate major cardiovascular adverse event incidence, to prolong duration of treatment, to improve efficacy."},{"outcome_type":"secondary","measure":"Rate of dose reduction, drug discontinuation and toxicities","time_frame":"5 years","description":"Safety as rate of dose reduction, drug discontinuation and toxicities"},{"outcome_type":"secondary","measure":"Response rate","time_frame":"5 years","description":"Response rate will include complete response (CR), very good partial response (VGPR) and partial response (PR) using the International Response Criteria. Responders are defined as subjects with at least a PR."},{"outcome_type":"secondary","measure":"Time to progression (TTP)","time_frame":"5 years","description":"Time to progression will be measured from the date of randomization to the date of first observation of PD, or deaths related to PD."},{"outcome_type":"secondary","measure":"Duration of response (DOR)","time_frame":"5 years","description":"Time between first documentation of response and PD. Responders without disease progression will be censored either at the time of lost to FU, at the time of death due to other cause than PD, or at the end of the study."},{"outcome_type":"secondary","measure":"Prognostic factors","time_frame":"5 years","description":"The following outcomes will be analysed in subgroups with different prognostic factors:\r\nProgression-free survival (PFS),\r\nTime to second disease progression (PFS2),\r\nTime to progression (TTP),\r\nTime to next therapy (TNT ),\r\nOverall survival (OS)"}]}
{"nct_id":"NCT03966677","start_date":"2019-07-01","enrollment":162,"brief_title":"Sensory Abnormalities in Post-surgical Peripheral Neuropathy","official_title":"Sensory Abnormalities in Post-surgical Peripheral Neuropathy: A Comparison of Subjects With and Without Severe Pain Using Normative Data","primary_completion_date":"2020-02-01","study_type":"Observational","rec_status":"Unknown status","completion_date":"2021-02-01","last_update":"2019-06-04","description":"The concept of normality is a cornerstone in medical practice and research. As an example, in clinical chemistry, a laboratory value based on a patient plasma sample, exceeding the +/- 1.96 x standard deviation (SD) range, referenced from a normative material, is per definition outside the normal range (the reference interval). Obviously, a number of reasons for this deviation may exist. The sample value could reflect a \"true\" pathological condition, but could just as well also be caused by error, e.g., technical measurement error, drug-interaction error, random error, or, reflect a value occurring in 5% of the healthy population. Conversely, a sample value in the normal range evidently does not exclude a pathological condition. The reference interval is calculated from a large number of healthy subjects sampled across age, anthropometrics, ethnicity and gender. Normative reference intervals are certainly of help particularly in the screening of subjects, but may be of limited value in the detailed assessment of pathophysiological processes. Also, increasing the number of analyses in a subject expands the risk of making a type I error (acquiring \"false\" positive results). The likelihood of one or more type I errors in the analysis of 10 different laboratory values in one subject, is impressive 46% ([1 - 0.95^10] =0.46). It is well-known that multiple measurements are commonly performed in medical practice and research, but corrected significance levels are not always used.","other_id":"H-16034340","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":65,"population":"Study subjects with pain after GHR (P-GHR) (n=54) Study subjects without pain after GHR\r\n        (NP-GHR) (n=54) Healthy non-operated study subjects (NP) (n=54)","criteria":"\n        INCLUSION CRITERIA:\r\n\r\n        All study subjects must meet all the following criteria to be eligible to enroll in the\r\n        study:\r\n\r\n          -  Age above 18 yrs and below 65 yrs\r\n\r\n          -  Signed informed consent\r\n\r\n          -  Body mass index (BMI): 18 < BMI < 35 kg/m^2\r\n\r\n          -  ASA I-II\r\n\r\n        In addition, for study subjects without pain after GHR (NP-GHR):\r\n\r\n          -  having undergone uncomplicated, elective, unilateral open GHR a.m. Lichtenstein\r\n\r\n          -  no restriction in ADL-functions due to the GHR\r\n\r\n          -  activity-related groin pain < 3 (numerical rating scale [NRS]: 0 = no pain, 10 = worst\r\n             imaginable pain)\r\n\r\n        EXCLUSION CRITERIA:\r\n\r\n        Any study subject, who meets one or more of the following criteria, is not suitable for\r\n        inclusion in this study:\r\n\r\n          -  do not speak or understand Danish\r\n\r\n          -  who cannot cooperate with the investigation\r\n\r\n          -  abuse of alcohol or drugs - according to investigator's evaluation\r\n\r\n          -  use of psychotropic drugs (exception of SSRI)\r\n\r\n          -  neurologic or psychiatric disease\r\n\r\n          -  chronic pain condition\r\n\r\n          -  regular use of analgesic drugs\r\n\r\n          -  skin lesions or tattoos in the assessment areas (groins, lower arm)\r\n\r\n          -  nerve lesions in the assessment sites (e.g., after trauma, abdominal surgery)\r\n\r\n        In addition, for healthy non-operated study subjects (NP):\r\n\r\n          -  subjects, who have had previous surgery in or near the groin region\r\n\r\n          -  use of prescription drugs one week before the trial\r\n\r\n          -  use of over-the-counter (OTC) drugs 48 hours before the trial\r\n\r\n          -  experiencing pain at rest > 3 (NRS)\r\n\r\n          -  experiencing activity-related pain in or near the groin > 3 (NRS)\r\n\r\n        In addition, for study subjects without pain after GHR (NP-GHR):\r\n\r\n          -  experiencing pain at rest > 3 (NRS)\r\n\r\n          -  experiencing activity-related pain in or near the groin > 3 (NRS)\r\n      ","sponsor":"University of Copenhagen","sponsor_type":"Other","conditions":"Chronic Pain","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Thermal thresholds","time_frame":"2019-2020","description":"Warmth detection threshold (WDT), cool detection threshold, heat pain threshold (HPT) and cold pain threshold (CPT) are made by a computerized contact thermode (Thermotest, Somedic AB, Sweden) with an active thermal surface of 12.5 cm^2 (2.5 x 5.0 cm^2) as previously described in detail. The thresholds are determined from a baseline temperature of 32°C with a ramp rate of + 1°C/s. Cut-offs for heat and cold are 50°C and 5°C, respectively. The assessments are made in triplicate and the mean values are used in the statistical analyses."},{"outcome_type":"primary","measure":"Pressure algometry","time_frame":"2019-2020","description":"Deep-tissue pain sensitivity is assessed using a hand-held pressure algometer with a neoprene-coated tip of area 1.0 cm2 (Somedic AB, Sweden), as previously described. The algometer is applied perpendicularly to the skin with a pressure rate of 30 kPa/s. The study subject is told to report the pressure pain threshold (PPT) by activating the button device when pain is perceived. The cut-off limit is 350 kPa. Testing is done in triplicate and the average value is used in the statistical analyses."},{"outcome_type":"primary","measure":"Suprathreshold heat stimulation","time_frame":"2019-2020","description":"A short tonic heat stimulus (heating area 12.5 cm^2; ramp rate: 1°C/s, plateau: 47°C, 5 s; STH) is delivered in order to evaluate the suprathreshold heat pain perception (NRS)."},{"outcome_type":"primary","measure":"Sensory mapping","time_frame":"2019-2020","description":"Sensory mapping in the groin areas is assessed with a 25°C metal roll (Somedic AB), moved at a rate of 1 to 2 cm/s from skin with normal cool perception, using an octagonal approach, into the areas in order to indicate sensory changes. Changes in the study subject's cool perception are indicated by a marker on the skin, and subsequently transferred to a transparent sheet for later area assessment in a vector-based drawing drawing program (Canvas 12.0; ACD Systems, Seattle, WA)."},{"outcome_type":"primary","measure":"Tactile thresholds","time_frame":"2019-2020","description":"Tactile detection thresholds (TDT) and tactile pain threshold (TPT) are determined by polyamide monofilaments (Stoelting, IL, USA; nominal buckling force ranging from 0.04 to 4,400 mN) using a modified Dixon up-and-down method, with 3 descending and 3 ascending stimulus intensities. The filament with the smallest buckling force leading to tactile recognition (TDT) is registered. The tactile pain threshold (TPT) is determined by the same stimulus paradigm, but registering the perception of pain (sharpness/sting; TPT)."},{"outcome_type":"primary","measure":"Temporal summation","time_frame":"2019-2020","description":"Temporal summation test, i.e., the perception in response to repetitive (0.3 to 3 Hz) mechanical stimulation [i.e., wind-up like pain: WUP], indicates presence of central sensitization. The repetitive 1 Hz stimuli for 60 s are either dynamically delivered by a brush or statically delivered by a polyamide filament (one nominal rank below TPT). The study subjects are told to report the level of pain (NRS) every 15 s-1 during the stimulation. Signs of aftersensations are followed 60 s after discontinuation of the stimulation, and the intensity of discomfort or pain is rated by NRS."},{"outcome_type":"secondary","measure":"Assessments of Anxiety and Depression","time_frame":"2019-2020","description":"Hospital Anxiety and Depression Scale (HADS; 14 items scale; 0-21 units)"},{"outcome_type":"secondary","measure":"Assessment of Pain Catastrophizing","time_frame":"2019-2020","description":"Pain Catastrophizing Scale (PCS; 13 item scale; 0-65 units)"}]}
{"nct_id":"NCT04164537","start_date":"2019-07-01","enrollment":25,"brief_title":"Latina Adolescent Depression Treatment Study","official_title":"Patient, Family, and Provider Perspectives on Latina Adolescents' Depression Treatment Engagement","primary_completion_date":"2021-06-30","study_type":"Observational","rec_status":"Completed","completion_date":"2021-06-30","last_update":"2021-08-06","description":"Despite experiencing higher rates of depressive symptoms and similar rates of Major Depressive Disorder (MDD), Latina (female) adolescents in the U.S. are significantly less likely than their non-Latina White peers to receive treatment for MDD. The purpose of this study is to identify facilitators of and barriers to depression treatment engagement among Latina adolescents across patient-, family-, and healthcare provider-levels from the perspectives of these individuals. Latina adolescent-parent dyads and healthcare providers will be recruited from community and healthcare settings. Separate individual semi-structured interviews will be conducted with Latina adolescents (n=12) and their parents (n=12). Two focus groups will be conducted with primary care providers (n=6) and mental health providers (n=6) who frequently care for Latina youth. Qualitative content analysis will be used to analyze the transcripts to determine common themes in facilitators and barriers across stakeholder groups.","other_id":"Pro00103001","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"Female","minimum_age":13,"maximum_age":17,"population":"Latina adolescent young women experiencing depression and their parents will be recruited\r\n        from community and integrated primary care settings. Healthcare providers will be recruited\r\n        from an integrated primary care clinic.","criteria":"\n        Adolescent Inclusion Criteria:\r\n\r\n          -  Ages 13-17\r\n\r\n          -  Self-identify as Hispanic/Latina\r\n\r\n          -  Be first generation (i.e. born outside the US) or second generation immigrants (i.e.\r\n             one or both parents born outside the US)\r\n\r\n          -  Have been diagnosed with Major Depressive Disorder or Persistent Depressive\r\n             Disorder/Dysthymia\r\n\r\n          -  Have been referred to psychotherapy or prescribed medication for depression\r\n\r\n        Adolescent Exclusion Criteria:\r\n\r\n          -  Currently experiencing acute psychological distress\r\n\r\n        Parent Inclusion Criteria\r\n\r\n          -  Parent of Latina adolescent experiencing depression\r\n\r\n        Parent Exclusion Criteria\r\n\r\n          -  Not fluent in English or Spanish\r\n\r\n        Healthcare Provider Inclusion Criteria\r\n\r\n          -  Self-identify as regularly providing clinical care to Latina adolescents with\r\n             depression\r\n\r\n          -  Be in a role in which they can refer to or provide depression treatment\r\n      ","sponsor":"Duke University","sponsor_type":"Other","conditions":"Depression","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Number of barriers to depression treatment among Latina adolescents generated from patient interviews and provider focus groups","time_frame":"Baseline"},{"outcome_type":"primary","measure":"Number of facilitators of depression treatment among Latina adolescents generated from patient interviews and provider focus groups","time_frame":"Baseline"},{"outcome_type":"primary","measure":"Number of preferences for depression treatment generated from patient interviews and provider focus groups","time_frame":"Baseline"}]}
{"nct_id":"NCT04126759","start_date":"2019-07-01","phase":"N/A","enrollment":15,"brief_title":"Calibration of a Non-invasive Glucose Measurement Device and Assessment of Its Performance in the Hypoglycemic Range in Patients With Type 1 Diabetes","official_title":"Calibration of a Non-invasive Glucose Measurement Device and Assessment of Its Performance in the Hypoglycemic Range in Patients With Type 1 Diabetes","primary_completion_date":"2020-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-01-31","last_update":"2020-10-08","description":"This clinical study has been launched to collect spectral Raman data and reference measurements to establish and validate a calibration model for the device during daily glycemic fluctuations and evaluate analytical performance of device in the hypoglycemic range. The study is a combined home-based and in-clinic study where subjects will attend the clinic two times.","other_id":"RSP-17","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Device Feasibility","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male and female subjects between 18 and 40 years of age.\r\n\r\n          -  Diagnosed with type 1 diabetes mellitus.\r\n\r\n          -  Uses an insulin pen or pump.\r\n\r\n          -  Hb1Ac > 55 mmol/mol at baseline visit.\r\n\r\n          -  Skin phototype 1-4 according to Fitzpatrick skin tone scale.\r\n\r\n          -  Willing to perform a minimum of 8 finger sticks per day during the study for the\r\n             home-based study and approximately 16 finger sticks for the in-clinic study days.\r\n\r\n          -  Willing to have a peripheral venous catheter inserted.\r\n\r\n          -  Willing to provide written signed and dated informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Breastfeeding, pregnant, attempting to conceive or not willing and able to practice\r\n             birth control according to approved contraceptives from NCA during the study execution\r\n             (applicable to female subjects only).\r\n\r\n          -  Subjects not able to understand and read Danish.\r\n\r\n          -  Inability to comply with the study procedures as described by the study protocol,\r\n             according to the opinion of the investigator.\r\n\r\n          -  Subject is not able to hold hand/arm steadily (including tremors and Parkinson's\r\n             Disease).\r\n\r\n          -  Reduced circulation in hand. \"Allen's test\" is used for assessing hand circulation to\r\n             evaluate occurrence of reduced blood.\r\n\r\n          -  Extensive skin changes, tattoos or diseases on probe application site (thenar) that\r\n             could interfere with the accuracy of the interstitial glucose measurements.\r\n\r\n          -  Known allergy to medical grade alcohol.\r\n\r\n          -  Having active cancer treatment and/or use tetracyclines and other medication / topical\r\n             agents known to increase photosensitivity in skin.\r\n\r\n          -  Medical history or any condition that may, in the opinion of the Investigator,\r\n             compromise the subject's ability to participate\r\n\r\n          -  Concomitant medical condition which could present a risk to the safety or welfare of\r\n             the subject or study staff.\r\n\r\n          -  Diagnosed with cardiovascular diseases.\r\n\r\n          -  Subjects currently enrolled in another study.\r\n\r\n          -  Radiotherapy for the past six months.\r\n      ","sponsor":"RSP Systems A/S","sponsor_type":"Industry","conditions":"Diabetes Mellitus","interventions":[{"intervention_type":"Device","name":"Device: P0.3","description":"Subjects will perform daily measurements on the IMD (Prototype 0.3) for 35 days."}],"outcomes":[{"outcome_type":"primary","measure":"Generation of predictive algorithms for determining blood glucose levels","time_frame":"12 months","description":"Collected spectral raman data will found the development of predictive algorithms for glucose determination."},{"outcome_type":"primary","measure":"Validation of predictive algorithms for determining blood glucose levels","time_frame":"12 months","description":"Performance of predictive models will be evaluated using the consensus error grid.Unified Performance (ISUP), Mean Absolute Relative Difference (MARD) and Consensus Error Grid (CEG) distribution."},{"outcome_type":"secondary","measure":"Risk/benefit analysis","time_frame":"12 months","description":"Support of a favorable risk/benefit analysis based on reported Adverse Device Effects and Serious Adverse Device Effects."},{"outcome_type":"secondary","measure":"Number of encountered Device Deficiencies","time_frame":"12 months","description":"Evaluation of Device Deficiencies with respect to identity, quality, durability or reliability, including malfunctions, use errors and inadequate labeling."}]}
{"nct_id":"NCT04029597","start_date":"2019-07-01","phase":"N/A","enrollment":100,"brief_title":"Remote Patient Monitoring in Pediatric Obesity","official_title":"Examining the Use of a Remote Patient Monitoring System in Pediatric Obesity","primary_completion_date":"2021-09-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-09-30","last_update":"2020-07-23","description":"The goal of this study is to examine the feasibility and efficacy of a remote patient monitoring system for children who are obese.","other_id":"2017-0083","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"open trial","sampling_method":"","gender":"All","minimum_age":8,"maximum_age":17,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  child 8 to 17 years of age attending an outpatient pediatric obesity clinic visit,\r\n\r\n          -  child weight status in the obese range (body mass index equal to or above the 95th\r\n             percentile for age and gender)\r\n\r\n          -  parent and child are fluent in English.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  child or parent history of cognitive impairment (developmental delay or intellectual\r\n             disability) by parent report that would impact ability to understand and complete\r\n             questionnaires or interact with the RPMS\r\n\r\n          -  child medical condition reported by parents that may prohibit wearing of the actigraph\r\n             device (e.g., pacemaker).\r\n      ","sponsor":"University of Mississippi Medical Center","sponsor_type":"Other","conditions":"Pediatric Obesity","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Remote Patient Monitoring","description":"Families participating in the study will receive standard medical care as well as the RPMS. The RPMS was developed in collaboration with the University of Mississippi Medical Center (UMMC) Center of Telehealth. Patients enrolled in this open trial of the RPMS will interact with the RPMS system on a daily basis and with UMMC's Center for Telehealth nurse care coordinators and research and clinical staff on an as needed basis. The RPMS will provide patients with include an electronic tablet (i.e., iPad) and the ability to receive data from the patient's weight scale and pedometer. Patients will be asked to wear the pedometer daily to track engagement in physical activity and weigh themselves weekly to track weight during the 3 month period. Educational information specific to pediatric obesity and healthy eating and engagement in physical activity will be presented daily through brief presentations and video clips."}],"outcomes":[{"outcome_type":"primary","measure":"Feasibility of using the RPMS","time_frame":"Post-Treatment (3 months)","description":"percent of queries answered and percent of health data collected from the RPMS via the weight scale and pedometer"},{"outcome_type":"primary","measure":"Satisfaction with using the RPMS","time_frame":"Post-Treatment (3 months)","description":"ratings from child and parent satisfaction questionnaire developed for use in the study"},{"outcome_type":"secondary","measure":"Weight Status","time_frame":"Post-Treatment (3 months) and Follow-up (6 months)","description":"BMI z-score change"},{"outcome_type":"secondary","measure":"Blood Pressure","time_frame":"Post-Treatment (3 months) and Follow-up (6 months)","description":"Systolic and Diastolic clinic assessed"},{"outcome_type":"secondary","measure":"Glucose","time_frame":"Post-Treatment (3 months) and Follow-up (6 months)","description":"clinic assessed"},{"outcome_type":"secondary","measure":"A1c","time_frame":"Post-Treatment (3 months) and Follow-up (6 months)","description":"clinic assessed"},{"outcome_type":"secondary","measure":"Dietary Intake","time_frame":"Post-Treatment (3 months) and Follow-up (6 months)","description":"24 hour dietary recall"},{"outcome_type":"secondary","measure":"Physical Activity","time_frame":"Post-Treatment (3 months) and Follow-up (6 months)","description":"actigraph assessed"},{"outcome_type":"secondary","measure":"Health-related Quality of Life","time_frame":"Post-Treatment (3 months) and Follow-up (6 months)","description":"child and parent report from PedsQL"},{"outcome_type":"secondary","measure":"Self-efficacy","time_frame":"Post-Treatment (3 months) and Follow-up (6 months)","description":"Child Report - combined summed total scores from Child Dietary Self-Efficacy Scale and Self-Efficacy for Physical Activity Scale, total scores range from 20-60, higher scores indicate higher self efficacy"},{"outcome_type":"secondary","measure":"Home food environment","time_frame":"Post-Treatment (3 months) and Follow-up (6 months)","description":"Parent-report"}]}
{"nct_id":"NCT03903640","start_date":"2019-07-01","phase":"Phase 2","enrollment":23,"brief_title":"Optune Device - TT Field Plus Nivolumab and Ipilimumab for Melanoma With Brain Metastasis","official_title":"Phase II Study of Optune Device - TT Field Plus Nivolumab and Ipilimumab for Melanoma With Brain Metastasis","primary_completion_date":"2024-01-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2027-07-31","last_update":"2021-08-16","description":"This phase II study will evaluate the safety of combining intermediate frequency electric field (TT Field) with immunotherapy in melanoma patients with brain metastasis. The data of this study will also inform whether this combination will offer advantage in progression free survival (PFS) and overall survival.","other_id":"201903162","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically or cytologically confirmed melanoma with metastasis to the brain.\r\n\r\n          -  Measurable disease defined as lesions that can be accurately measured in at least one\r\n             dimension (longest diameter to be recorded) as  10 mm with CT scan or MRI, as  20 mm\r\n             by chest x-ray, or  10 mm with calipers by clinical exam.\r\n\r\n          -  Candidate for treatment with immunotherapy.\r\n\r\n          -  At least 18 years of age.\r\n\r\n          -  Normal bone marrow and organ function as defined below:\r\n\r\n               -  Absolute neutrophil count  1,500/mcl\r\n\r\n               -  Platelets  100,000/mcl\r\n\r\n               -  Total bilirubin  1.5 x IULN\r\n\r\n               -  AST(SGOT)/ALT(SGPT)  3.0 x IULN\r\n\r\n               -  Creatinine  IULN OR creatinine clearance  60 mL/min/1.73 m2 for patients with\r\n                  creatinine levels above institutional normal\r\n\r\n          -  Women of childbearing potential and men must agree to use adequate contraception\r\n             (hormonal or barrier method of birth control, abstinence) prior to study entry and for\r\n             the duration of study participation, including at least 5 months (for women of\r\n             childbearing potential) and at least 7 months (for men) after last dose of study drug.\r\n             Should a woman become pregnant or suspect she is pregnant while participating in this\r\n             study, she must inform her treating physician immediately.\r\n\r\n          -  Ability to understand and willingness to sign an IRB approved written informed consent\r\n             document (or that of legally authorized representative, if applicable).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Received treatment in the metastatic setting\r\n\r\n          -  Treated with whole brain radiation Receiving targeted therapy or on immunosuppressive\r\n             agents (dexamethasone> 4mg/day) within 1 week of therapy.\r\n\r\n          -  A history of other malignancy  5 years previous with the exception of basal cell or\r\n             squamous cell carcinoma of the skin which were treated with local resection only or\r\n             carcinoma in situ of the cervix.\r\n\r\n          -  Currently receiving any other investigational agents.\r\n\r\n          -  A history of allergic reactions attributed to compounds of similar chemical or\r\n             biologic composition to nivolumab, ipilimumab, or other agents used in the study.\r\n\r\n          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active\r\n             infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac\r\n             arrhythmia.\r\n\r\n          -  History of pre-existing immunodeficiency disorder or autoimmune condition requiring\r\n             immunosuppressive therapy. This includes inflammatory bowel disease, ulcerative\r\n             colitis, Crohn's disease, systemic vasculitis, scleroderma, psoriasis, multiple\r\n             sclerosis, hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis,\r\n             systemic lupus erythematosus, Sjgren's syndrome, sarcoidosis, or other rheumatologic\r\n             disease or any other medical condition or use of medication which might make it\r\n             difficult for the patient to complete the full course of treatments or to generate an\r\n             immune response to vaccines.\r\n\r\n          -  Known sensitivity to conductive hydrogels.\r\n\r\n          -  Skull defects such as missing bone or bullet fragments.\r\n\r\n          -  Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, vagus\r\n             nerve stimulator, and other implanted electronic devices in the brain or spinal cord.\r\n\r\n          -  Pregnant and/or breastfeeding. Women of childbearing potential must have a negative\r\n             pregnancy test within 14 days of study entry.\r\n\r\n          -  Known HIV-positivity on combination antiretroviral therapy because of the potential\r\n             for pharmacokinetic interactions with nivolumab and/or ipilimumab. In addition, these\r\n             patients are at increased risk of lethal infections when treated with\r\n             marrow-suppressive therapy. Appropriate studies will be undertaken in patients\r\n             receiving combination antiretroviral therapy when indicated.\r\n      ","sponsor":"Washington University School of Medicine","sponsor_type":"Other","conditions":"Melanoma With Brain Metastasis","interventions":[{"intervention_type":"Device","name":"Device: Optune","description":"-Optune is programmed by Novocure to deliver 200 kHz TTFields in two sequential, perpendicular field directions at a maximal intensity of 707mARMS."},{"intervention_type":"Biological","name":"Biological: Nivolumab","description":"-Standard of care"},{"intervention_type":"Biological","name":"Biological: Ipilimumab","description":"-Standard of care"}],"outcomes":[{"outcome_type":"primary","measure":"Intracranial progression-free survival","time_frame":"At 6 months","description":"The PFS time will be calculated as the duration of time from the date of first dose of study treatment to the date of earliest intracranial progression or death, whichever occurs first. Patients who neither progress nor die by the data cutoff date will be censored at the last follow up.\r\nProgressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions)."},{"outcome_type":"secondary","measure":"Overall survival","time_frame":"At 6 months","description":"-Defined as the duration of time from the date of first dose of study treatment to death from any cause. Patients who are alive by the data cutoff date will be censored at the last follow up."},{"outcome_type":"secondary","measure":"Best intracranial response rate","time_frame":"Until disease progression or death (up to 3 years after off-treatment date)","description":"Defined as the percentage of patients with a confirmed intracranial complete or partial response\r\nUsing modified RANO criteria"},{"outcome_type":"secondary","measure":"Best extracranial response rate","time_frame":"Until disease progression or death (up to 3 years after off-treatment date)","description":"Defined as the percentage of patients with a confirmed extracranial complete or partial response\r\nUsing modified RANO criteria"},{"outcome_type":"secondary","measure":"Extracranial progression-free survival","time_frame":"At 6 months","description":"Defined as the duration of time from the date of first dose of study treatment to the date of earliest extracranial progression or death, whichever occurs first. Patients who neither progress nor die by the data cutoff date will be censored at the last follow up.\r\nUsing modified RANO criteria"},{"outcome_type":"secondary","measure":"Safety of the treatment regimen as measured by number of treatment-related grade 3 or greater adverse events and discontinuations due to treatment related adverse events.","time_frame":"Through 100 days after completion of treatment (estimated to be 1 year and 100 days)","description":"-The descriptions and grading scales found in CTCAE version 5.0."}]}
{"nct_id":"NCT03159806","start_date":"2019-07-01","enrollment":0,"brief_title":"Detecting Markers of Kidney Function With Intravenous Microdialysis","official_title":"Optimising the Recovery of Kidney Function Markers Using a CE-marked Intravenous Microdialysis Probe","primary_completion_date":"2019-12-01","study_type":"Observational","rec_status":"Withdrawn","completion_date":"2019-12-01","last_update":"2020-10-14","description":"Patients will be invited to participate from an outpatient nephrology clinic at Hammersmith Hospital. They will have a microdialysis catheter inserted into a peripheral vein and connected to a sampling system. The samples will be sent for analysis in the hospital laboratory. All medical devices to be used are already CE-marked and approved for these purposes.","other_id":"MD001","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":85,"population":"Normal cross-section of adults attending outpatient nephrology clinic","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Attending nephrology outpatient clinic\r\n\r\n          -  Aged 18-85\r\n\r\n          -  Able to spare 3.5 hours to participate in study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Lacks capacity to consent\r\n\r\n          -  Unable to consent in English\r\n\r\n          -  No visible peripheral veins\r\n      ","sponsor":"Accunea Ltd.","sponsor_type":"Industry","conditions":"Kidney Diseases","interventions":[{"intervention_type":"Device","name":"Device: Microdialysis sampling","description":"Insertion of CE-marked intravenous microdialysis catheter, use of CE-marked microdialysis pump to collect intravenous microdialysis samples"}],"outcomes":[{"outcome_type":"primary","measure":"Recovery of biochemicals of interest","time_frame":"6 months","description":"Calculation of optimal microdialysis settings for recovery of specific biochemicals by intravenous microdialysis"}]}
{"nct_id":"NCT03991871","start_date":"2019-07-01","phase":"N/A","enrollment":50,"brief_title":"HARapan kiTa ECP (External Counter Pulsation) Study HARTEC Study","official_title":"HARapan kiTa ECP (External Counter Pulsation) Study HARTEC Study","primary_completion_date":"2020-08-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2020-08-01","last_update":"2020-06-16","description":"External Counterpulsation Therapy (ECP) is a therapeutic procedure that performed on patients with angina or heart failure to relieve the ischaemic symptoms, improve functional capacity, and quality of life. In recent studies, ECP has already proved to reduce angina symptoms, decrease degree of ischemic in heart train test. External Counterpulsation Therapy (ECP) therapy is a non-invasive technique for sequentially pressuring calf, lower thighs, and upper thighs through developed cuffs at pressure above systolic blood pressure when diastole, then deflated at systole.","other_id":"HARTEC Study","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Comparison between two groups","sampling_method":"","gender":"All","minimum_age":21,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  age 21 - 80 years\r\n\r\n          -  Refractory angina CCS III-IV whom are not candidate for Re-revascularization with\r\n             proven data of: have stenosis on left main more than 50%, stenosis on main coronary\r\n             right artery more than 70% or stenosis more than 70% on others vessels, conducted in\r\n             coronary surgery conference with conservative decision (optimal medica mentosa).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  aorta aneurysm,\r\n\r\n          -  abdominalis aneurysm,\r\n\r\n          -  acute coronary syndrome,\r\n\r\n          -  acute heart failure,\r\n\r\n          -  heavy aortic regurgitation,\r\n\r\n          -  malignant arrhythmia,\r\n\r\n          -  blood pressure above 180/100mmHg,\r\n\r\n          -  acute limb ischaemia,\r\n\r\n          -  DVT,\r\n\r\n          -  active thrombophlebitis,\r\n\r\n          -  pregnancy\r\n      ","sponsor":"National Cardiovascular Center Harapan Kita Hospital Indonesia","sponsor_type":"Other","conditions":"Cardiac Rehabilitation|Angiogenesis|Refractory Angina","interventions":[{"intervention_type":"Device","name":"Device: External Counter Pulsation (ECP) therapy","description":"35 hours ECP treatment in 35 sessions"}],"outcomes":[{"outcome_type":"primary","measure":"Angiopoietin I concentration","time_frame":"7 weeks","description":"hemodynamic effect on coronary perfusion. angiopoietin I involve in angiogenesis process. this study aims to investigate effects of External counterpulsation for refractory angina patients. it hypothesized to increase collateral artery which mechanism is by increasing angiogenesis process, measured with increase of Angiopoietin I and decrease of Angiopoietin II. Angiopoietin I level will be measured using ELISA technique."},{"outcome_type":"primary","measure":"MiRNA 92a concentration","time_frame":"7 weeks","description":"microRNAs (miRNAs) are short (20-24 nt) non-coding RNAs that are involved in post-transcriptional regulation of gene expression in multicellular organisms by affecting both the stability and translation of mRNAs. miRNAs are transcribed by RNA polymerase II as part of capped and polyadenylated primary transcripts (pri-miRNAs) that can be either protein-coding or non-coding. The primary transcript is cleaved by the Drosha ribonuclease III enzyme to produce an approximately 70-nt stem-loop precursor miRNA (pre-miRNA), which is further cleaved by the cytoplasmic Dicer ribonuclease to generate the mature miRNA and antisense miRNA star (miRNA*) products. The mature miRNA is incorporated into a RNA-induced silencing complex (RISC), which recognizes target mRNAs through imperfect base pairing with the miRNA and most commonly results in translational inhibition or destabilization of the target mRNA. inhibition of MiRNA 92a prevents endothelial dysfunction."},{"outcome_type":"primary","measure":"Angiopoietin II concentration","time_frame":"7 weeks","description":"Angiopoietin II established to play a role in blood vessel angiogenesis, antagonist of signaling through Tie2 tyrosine kinase receptor"},{"outcome_type":"secondary","measure":"VEGFR-2 concentration","time_frame":"7 weeks","description":"Vascular endothelial growth factor receptor-2 concentration, measured using ELISA"},{"outcome_type":"secondary","measure":"VEGF concentration","time_frame":"7 weeks","description":"Vascular endothelial growth factor concentration, measured in plasma, using ELISA method"},{"outcome_type":"secondary","measure":"NT pro BNP concentration","time_frame":"7 weeks","description":"Marker of heart failure. NTpro BNP will be measured pre and post external counterpulsation. BNP is actually produced primarily by the left ventricle of the heart (the heart's main pumping chamber). It is associated with blood volume and pressure and with the work that the heart must do in pumping blood throughout the body. Small amounts of a precursor protein, pro-BNP, are continuously produced by the heart. Pro-BNP is then cleaved by the enzyme called corin to release the active hormone BNP and an inactive fragment, NT-proBNP, into the blood.When the left ventricle of the heart is stretched, the concentrations of BNP and NT-proBNP produced can increase markedly. This situation indicates that the heart is working harder and having more trouble meeting the body's demands. This may occur with heart failure as well as with other diseases that affect the heart and circulatory system."},{"outcome_type":"secondary","measure":"6 minute walking test distance (meters)","time_frame":"7 weeks","description":"6 minutes walking test has long been known to measure functional capacity, will be measured pre and post ECP. 6-minutes walking test measuremet is in meter. it measure how far the participants could walk in 6 minutes."},{"outcome_type":"secondary","measure":"NYHA Class index","time_frame":"7 weeks","description":"New York Heart Association (NYHA) Functional Classification to classify severity of heart failure symptoms. It places patients in one of four categories based on how much they are limited during physical activity."},{"outcome_type":"secondary","measure":"CCS Class index","time_frame":"7 weeks","description":"Canadian Cardiovascular Society (CCS) classify angina symptoms into CCS class. it is to classify severity of angina symptoms. it places patients in one of four categories based on the severity of the angina on affecting and limiting phisical activity."},{"outcome_type":"secondary","measure":"WHO 5 index","time_frame":"7 weeks","description":"measuring quality of life, it will be measured pre and post ECP. The 5-item World Health Organization Well-Being Index (WHO-5) is among the most widely used questionnaires assessing subjective psychological well-being. Since its first publication in 1998, the WHO-5 has been translated into more than 30 languages and has been used in research studies all over the world. We now provide a systematic review of the literature on the WHO-5."}]}
{"nct_id":"NCT03445780","start_date":"2019-06-30","phase":"Phase 1","enrollment":0,"brief_title":"Comparison of Distraction Methods for Pain Relief of Trigger Finger Injection","official_title":"Comparison of Distraction Methods for Pain Relief of Trigger Finger Injection","primary_completion_date":"2020-04-30","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2020-04-30","last_update":"2020-01-27","description":"The purpose of this study is to evaluate the best distraction mechanism during trigger finger injection in the outpatient setting. Temporary discomfort from the needle prick is highly feared by patients and is often accompanied by significant acute pain and distress during routine corticosteroid injection in the orthopedic outpatient setting. This study aims to examine 4 different distraction methods and their efficacy in reducing perceived pain, which will be evaluate using the VAS (visual analog pain score.) The three distraction methods will be ethyl chloride spray, adjacent pinch, ethyl chloride spray and pinch, and \"screen\" or looking away method.","other_id":"17-01275","allocation":"Randomized","intervention_model":"Factorial Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":99,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosis of Trigger Finger\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Allergies to lidocaine, betamethasone, infection, pregnancy, 3 prior injection to the\r\n             digit\r\n      ","sponsor":"NYU Langone Health","sponsor_type":"Other","conditions":"Trigger Finger","interventions":[{"intervention_type":"Drug","name":"Drug: Ethyl chloride spray","description":"Skin cooling with ethyl chloride spray 5 seconds prior to injection"},{"intervention_type":"Procedure","name":"Procedure: Pinching","description":"Skin between the distal palmar crease and the palmo digital crease will be pinched for 5 seconds prior to injection"},{"intervention_type":"Procedure","name":"Procedure: No Site of Procedure","description":"Subjects will sit behind a screen with a small opening large enough to introduce the injected hand. They will not see any of the procedure"}],"outcomes":[{"outcome_type":"primary","measure":"Change in Visual Analog Scale (VAS) Score","time_frame":"1 Minute, 24 Hours","description":"A 10-cm scale will be shown to the patients, and they will be asked to choose the proper number, with 1 representing no pain and 10 symbolizing the most pain imaginable"}]}
{"nct_id":"NCT03891979","start_date":"2019-06-25","phase":"Phase 4","enrollment":0,"brief_title":"Gut Microbiome Modulation to Enable Efficacy of Checkpoint-based Immunotherapy in Pancreatic Adenocarcinoma","official_title":"A Pilot Study of Gut Microbiome Modulation to Enable Efficacy of Checkpoint-based Immunotherapy in Pancreatic Adenocarcinoma","primary_completion_date":"2020-06-01","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2020-06-01","last_update":"2020-06-26","description":"A multi-institutional, single arm pilot study of antibiotics and pembrolizumab for the treatment of surgically resectable pancreatic cancer. The primary purpose of this study is to determine the change in immune activation in pancreatic tumor tissue following treatment with antibiotics and pembrolizumab.","other_id":"18-00137","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":1.5,"maximum_age":100,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically confirmed pancreatic adenocarcinoma. Histologies other than\r\n             adenocarcinoma, or any mixed histologies, will NOT be eligible. *Note: histology must\r\n             be confirmed prior to study treatment, however, participants may be consented to study\r\n             based on imaging results consistent with pancreatic adenocarcinoma and then undergo\r\n             diagnostic and research biopsy simultaneously.\r\n\r\n          -  Clinical stage I and II disease (per AJCC 8th ed)\r\n\r\n          -  Resectable pancreatic cancer as defined by NCCN Guidelines 1.2018 and based on\r\n             pancreatic protocol dual-phase CT imaging. Multi-detector computed tomography (MDCT)\r\n             angiography, performed by acquiring thin, preferably sub-millimeter, axial sections\r\n             using a dual-phase pancreatic protocol, with images obtained in the pancreatic and\r\n             portal venous phase of contrast enhancement, is required.\r\n\r\n          -  No arterial tumor contact (celiac axis [CA], superior mesenteric artery [SMA], or\r\n             common hepatic artery [CHA])\r\n\r\n          -  No tumor contact with the superior mesenteric vein (SMV) or portal vein (PV) or 180\r\n             contact without vein contour irregularity\r\n\r\n          -  Patients must agree to pre-treatment biopsy and definitive surgical resection\r\n\r\n          -  ECOG performance status of 0 or 1\r\n\r\n          -  No prior treatment for diagnosis of pancreatic cancer\r\n\r\n          -  Normal organ and marrow function\r\n\r\n          -  Absolute neutrophil count (ANC) 1500/L\r\n\r\n          -  Platelets 100 000/L\r\n\r\n          -  Hemoglobin 9.0 g/dL or 5.6 mmol/La\r\n\r\n          -  Renal Creatinine OR Measured or calculated by creatinine clearance (GFR can also be\r\n             used in place of creatinine or CrCl) 1.5  ULN OR\r\n\r\n             30 mL/min for participant with creatinine levels >1.5  institutional ULN\r\n\r\n          -  Hepatic Total bilirubin 1.5 ULN OR direct bilirubin ULN for participants with total\r\n             bilirubin levels >1.5  ULN\r\n\r\n          -  AST (SGOT) and ALT (SGPT) 2.5  ULN\r\n\r\n          -  Coagulation International normalized ratio (INR) OR prothrombin time (PT)\r\n\r\n          -  Activated partial thromboplastin time (aPTT) 1.5  ULN unless participant is\r\n             receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of\r\n             intended use of anticoagulants\r\n\r\n          -  ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST\r\n             (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase);\r\n             GFR=glomerular filtration rate; ULN=upper limit of normal.\r\n\r\n          -  Criteria must be met without erythropoietin dependency and without packed red blood\r\n             cell (pRBC) transfusion within last 2 weeks.\r\n\r\n          -  Creatinine clearance (CrCl) should be calculated per institutional standard. Note:\r\n             This table includes eligibility-defining laboratory value requirements for treatment;\r\n             laboratory value requirements should be adapted according to local regulations and\r\n             guidelines for the administration of specific chemotherapies.\r\n\r\n          -  Ability to understand and sign a written informed consent document. Participant must\r\n             have willingness and ability to comply with scheduled visits, treatment plans,\r\n             laboratory tests and other study procedures.\r\n\r\n          -  A female participant is eligible to participate if she is not pregnant (see Appendix\r\n             1), not breastfeeding, and at least one of the following conditions applies:\r\n\r\n          -  Not a woman of childbearing potential (WOCBP) as defined in Appendix 1 OR\r\n\r\n          -  A WOCBP who agrees to follow the contraceptive guidance in Appendix 1 during the\r\n             treatment period and for at least 120 days plus 30 days (a menstruation cycle) after\r\n             the last dose of study treatment.\r\n\r\n          -  Males who are sexually active with WOCBP must agree to follow instructions for\r\n             method(s) of contraception (see Appendix 1) for the duration of treatment with study\r\n             treatment(s) and for a total of 180 days posttreatment completion. In addition, male\r\n             participants must be willing to refrain from sperm donation during this time.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Borderline resectable, locally advanced or distant metastatic disease\r\n\r\n          -  Any medical condition which makes definitive surgical resection of the pancreatic\r\n             cancer contraindicated due to high risk of morbidity/mortality\r\n\r\n          -  Has active autoimmune disease that has required systemic treatment in past 2 years\r\n             (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive\r\n             drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid\r\n             replacement therapy for adrenal or pituitary insufficiency) is not considered a form\r\n             of systemic treatment.\r\n\r\n             4. Medical history and concurrent disease as below:\r\n\r\n              Participants with a condition requiring systemic treatment with either\r\n             corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive\r\n             medications within 14 days of study treatment administration except for adrenal\r\n             replacement steroid doses > 10 mg daily prednisone equivalent in the absence of active\r\n             autoimmune disease.\r\n\r\n        Note: Treatment with a short course of steroids (< 5 days) up to 7 days prior to initiating\r\n        study treatment is permitted. Participants with asthma that require intermittent use\r\n        intermittent use of bronchodilators, inhaled steroids, or local steroid injections would\r\n        not be excluded from the study.\r\n\r\n          -  Interstitial lung disease that is symptomatic or may interfere with the detection or\r\n             management of suspected treatment-related pulmonary toxicity.\r\n\r\n          -  Uncontrolled or significant cardiovascular disease including, but not limited to, any\r\n             of the following:\r\n\r\n               -  Myocardial infarction or stroke/transient ischemic attack within the past 6\r\n                  months\r\n\r\n               -  Uncontrolled angina within the past 3 months\r\n\r\n               -  Any history of clinically significant arrhythmias (such as ventricular\r\n                  tachycardia, ventricular fibrillation, or torsades de pointes)\r\n\r\n               -  History of other clinically significant heart disease (eg, cardiomyopathy,\r\n                  congestive heart failure with New York Heart Association functional\r\n                  classification III to IV, pericarditis, significant pericardial effusion, or\r\n                  myocarditis)\r\n\r\n               -  Cardiovascular disease-related requirement for daily supplemental oxygen therapy.\r\n\r\n          -  Evidence of uncontrolled, active infection, requiring parenteral or oral\r\n             anti-bacterial, anti-viral or anti-fungal therapy  28 days prior to screening on\r\n             study.\r\n\r\n          -  Participants with a condition requiring chronic systemic oral treatment with either\r\n             antibiotics or anti-fungals\r\n\r\n          -  Any uncontrolled inflammatory GI disease including Crohn's Disease and ulcerative\r\n             colitis.\r\n\r\n               -  Participants with active, known, or suspected autoimmune disease. Participants\r\n                  with vitiligo, type I diabetes mellitus, residual hypothyroidism due to\r\n                  autoimmune condition only requiring hormone replacement, euthyroid participants\r\n                  with a history of Grave's disease (participants with suspected autoimmune thyroid\r\n                  disorders must be negative for thyroglobulin and thyroid peroxidase antibodies\r\n                  and thyroid stimulating immunoglobulin prior to first dose of study treatment),\r\n                  psoriasis not requiring systemic treatment, or conditions not expected to recur\r\n                  in the absence of an external trigger are permitted to enroll after discussing\r\n                  with the Principal Investigator.\r\n\r\n               -  Has received a live vaccine within 30 days prior to the first dose of study drug.\r\n                  Examples of live vaccines include, but are not limited to, the following:\r\n                  measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies,\r\n                  Bacillus Calmette-Gurin (BCG), and typhoid vaccine. Seasonal influenza vaccines\r\n                  for injection are generally killed virus vaccines and are allowed; however,\r\n                  intranasal influenza vaccines (eg, FluMist) are live attenuated vaccines and are\r\n                  not allowed. *Note: for those participants who will be undergoing planned\r\n                  splenectomy, vaccinations against S. pneumoniae, N. meningitidis, H. influenzae\r\n                  type b and influenza virus should be administered at least 2 weeks after the\r\n                  surgical intervention.\r\n\r\n               -  Known human immunodeficiency virus (HIV), known active hepatitis A, or known\r\n                  hepatitis B or C infection.\r\n\r\n               -  History of acute diverticulitis within the last 6 months or current chronic\r\n                  diarrhea\r\n\r\n               -  Expected to require any other form of antineoplastic or surgical therapy while on\r\n                  study\r\n\r\n               -  Pregnant or lactating women\r\n\r\n               -  A WOCBP who has a positive urine pregnancy test within 72 hours or no pregnancy\r\n                  test prior to registration (see Appendix 1). If the urine test is positive or\r\n                  cannot be confirmed as negative, a serum pregnancy test will be required.\r\n\r\n        Note: in the event that >72 hours have elapsed between the screening pregnancy test and the\r\n        first dose of study treatment, another pregnancy test (urine or serum) must be performed\r\n        and must be negative in order for subject to start receiving study medication.\r\n\r\n          -  WOCBP who are unwilling or unable to use an acceptable method to minimize the risk of\r\n             pregnancy (see Appendix 1) for the entire study period and 120 days plus 30 days (a\r\n             menstruation cycle) after the last dose of study treatment. WOCBP who are continuously\r\n             not heterosexually active are also exempt from contraceptive requirements, but still\r\n             must undergo pregnancy testing as described in section 20.\r\n\r\n          -  Sexually active fertile men not using effective birth control if their partners are\r\n             WOCBP\r\n\r\n          -  History of primary immunodeficiency\r\n\r\n          -  Has a history of (non-infectious) pneumonitis that required steroids or has current\r\n             pneumonitis.\r\n\r\n          -  History of organ allograft or allogeneic bone marrow transplant.\r\n\r\n          -  Any prior radiation therapy, immunotherapy, or biologic ('targeted') therapy for\r\n             treatment of the patient's pancreatic tumor. Biliary stent is allowed.\r\n\r\n          -  Treatment for other invasive carcinomas within the last two years who are at greater\r\n             than 5% risk of recurrence at time of eligibility screening. Carcinoma in-situ and\r\n             basal cell carcinoma/ squamous cell carcinoma of the skin are allowed.\r\n\r\n          -  Participation in any investigational drug study within 4 weeks preceding the start of\r\n             study treatment.\r\n\r\n          -  Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment,\r\n             without complete recovery.\r\n\r\n          -  History of allergy to study treatments or any of its components\r\n      ","sponsor":"NYU Langone Health","sponsor_type":"Other","conditions":"Pancreatic Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Pembrolizumab","description":"Pembrolizumab will be given for two doses every 3 weeks starting on day 8 (ie days 8 and 29). Antibiotics will continue throughout the entire four week pre-operative period.\r\nCiprofloxacin 500mg PO BID days 1-29; Metronidazole 500mg PO TID days 1-29; Pembrolizumab 200mg IV days 8 and 29."},{"intervention_type":"Drug","name":"Drug: Ciprofloxacin 500mg PO BID days 1-29","description":"Antibiotics will continue throughout the entire four week pre-operative period."},{"intervention_type":"Drug","name":"Drug: Metronidazole 500mg PO TID days 1-29","description":"Antibiotics will continue throughout the entire four week pre-operative period."}],"outcomes":[{"outcome_type":"primary","measure":"Change in immune activation in pancreatic tumor tissue following treatment with antibiotics and pembrolizumab measured by activation of HLA-DR,","time_frame":"12 Weeks","description":"activation is defined as an increase of 20% or more over baseline in percentage of T cells expressing the marker."},{"outcome_type":"primary","measure":"Change in immune activation in pancreatic tumor tissue following treatment with antibiotics and pembrolizumab measured by activation of","time_frame":"12 Weeks","description":"activation is defined as an increase of 20% or more over baseline in percentage of T cells expressing the marker."}]}
{"nct_id":"NCT03995732","start_date":"2019-06-18","phase":"Phase 2","enrollment":120,"brief_title":"Efficacy and Safety Evaluation of PC-SOD for Injection in Reducing Myocardial Reperfusion Injury","official_title":"Efficacy and Safety Evaluation of Phosphatidyl Choline Cu/Zn Superoxide Dismutase (PC-SOD) for Injection in Reducing Myocardial Reperfusion Injury: a Multicenter, Randomized, Single-blind, Placebo-controlled Dose-finding Study","primary_completion_date":"2020-10-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2021-03-30","last_update":"2019-09-26","description":"The current study aims to evaluate different doses of PC-SOD injections for efficacy and safety in comparison to placebo, in order to provide a basis for future clinical trials in terms of experimental design and dose selection.","other_id":"CY-RD101-2","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age 18 - 75 years, male or female;\r\n\r\n          2. Meeting the diagnostic criteria of AMI (chest pain for over 10 - 20 min, which could\r\n             not be relieved completely by oral nitroglycerin; ST elevation  2 mm in two or more\r\n             adjacent leads in leads V1-V5 );\r\n\r\n          3. Killip classes I or II;\r\n\r\n          4. Coronary angiography possible within 6 hours of onset;\r\n\r\n          5. Emergent coronary angiography showing occlusion in left anterior descending artery\r\n             (TIMI grade 0 - 1); patients with this symptom could also be included despite\r\n             inconformity to criterion 2);\r\n\r\n          6. Willingness to participate in the trial with ethical approval and informed consent\r\n             provision.\r\n\r\n        Exclusion Criteria:\r\n\r\n        General exclusion criteria\r\n\r\n          1. Previous history of myocardial infarction;\r\n\r\n          2. History of myocardial revascularization before screening;\r\n\r\n          3. Thrombolytic treatment after onset;\r\n\r\n          4. Cardiogenic shock;\r\n\r\n          5. Cardiopulmonary resuscitation between onset and screening;\r\n\r\n          6. Atrial fibrillation, atrioventricular block (degree I, II or III), and other severe\r\n             arrhythmias that cannot be corrected and affect hemodynamics;\r\n\r\n          7. Suspected of aortic dissection;\r\n\r\n          8. Diabetes with long-term insulin use, or definite macrovascular or small vascular\r\n             lesions (stroke, diabetic nephropathy, retinopathy, diabetic foot, and etc.);\r\n\r\n          9. History of major surgeries within 6 months;\r\n\r\n         10. History of stroke within 6 months;\r\n\r\n         11. History of immune disorders within 6 months (such as cancer, lymphoma, HIV or\r\n             hepatitis), or use of immunosuppressive agents at doses that can cause\r\n             immunosuppression within 10 days;\r\n\r\n         12. Clinically significant diseases of the respiratory, digestive, blood, immune,\r\n             endocrine, nervous or urinary systems (renal insufficiency in particular), and\r\n             diseases that might cause serious risk to patients based on the judgement of\r\n             researchers;\r\n\r\n         13. Allergy to two or more drugs and/or foods, or known allergy to sucrose;\r\n\r\n         14. Any contraindications for cardiac MRI, such as implantation of metal objects\r\n             (pacemakers and/or implantable defibrillators; insulin pumps, or any other electronic\r\n             devices; cerebral clips, aneurysm clips, and etc.), and other contraindications (such\r\n             as claustrophobia);\r\n\r\n         15. Pregnancy or lactation in women;\r\n\r\n         16. Participation in other clinical trials within 3 months;\r\n\r\n         17. Situations considered unsuitable for enrollment (such as disease condition or patient\r\n             compliance).\r\n\r\n        Exclusion criteria for angiography\r\n\r\n          1. Occlusion of left main artery;\r\n\r\n          2. Apart from the left anterior descending branch, other blood vessels requiring\r\n             revascularization in the same period or within a month.\r\n      ","sponsor":"Beijing Tide Pharmaceutical Co., Ltd","sponsor_type":"Industry","conditions":"Myocardial Reperfusion Injury","interventions":[{"intervention_type":"Drug","name":"Drug: PC-SOD","description":"PC-SOD will be dissolved in 10 mL of 5% glucose injection and intravenously administrated before recanalization."},{"intervention_type":"Drug","name":"Drug: placebo","description":"Placebo will be dissolved in 10 mL of 5% glucose injection and intravenously administrated before recanalization."}],"outcomes":[{"outcome_type":"primary","measure":"The myocardial salvage index at 7 d after PCI","time_frame":"7 days","description":"The myocardial salvage index is defined as (area of myocardial edema - area of myocardial infarction)/area of myocardial edema."},{"outcome_type":"primary","measure":"The area of myocardial infarction at 7 d after PCI (detected by delayed-enhanced MRI [Magnetic Resonance Imaging] )","time_frame":"7 days","description":"The area of myocardial infarction is defined as the percentage of left ventricular myocardium occupied by delayed enhancement."},{"outcome_type":"primary","measure":"Area of microvascular occlusion at 7 d after PCI","time_frame":"7 days","description":"Microvascular occlusion is defined as the area with no enhancement in the infarcted regions where delayed enhancement can be observed on MRI scans."},{"outcome_type":"primary","measure":"The area of infarction determined by the AUC (area under curve) for CK-MB (creatine kinase-muscle/brain) at 72h after PCI.","time_frame":"72 hours","description":"The area of infarction at 72h after surgery will be roughly estimated by calculating the AUC for CK-MB (before operation, and at 6, 12, 24, 48 and 72h after operation, respectively)."},{"outcome_type":"primary","measure":"Cardiac function at 7 d after PCI","time_frame":"7 days","description":"Cardiac function is assessed by assessing the left ventricular ejection fraction (percentage of stroke output to end-diastolic volume)."},{"outcome_type":"primary","measure":"The TIMI (thrombolysis in myocardial infarction) grade of coronary blood flow after PCI.","time_frame":"within 24 hours","description":"Coronary artery reperfusion will be assessed by the TIMI grading system, whose grades include:\r\nGrade 0: no contrast filling at the occlusion site and distal end; Grade 1: the contrast passes some of the occluded sites, but cannot fill the distal vessels; Grade 2: the contrast can fill the distal end of coronary artery completely, but the filling and clearing of contrast is slower than that of normal coronary artery; Grade 3: the contrast can fill the distal end rapidly and completely, and can be removed quickly.\r\nThe TIMI flow grades will be determined by two physicians separately. In case of disagreement, a lead physician will help make the final call."},{"outcome_type":"primary","measure":"The corrected TIMI frame count (cTFC) after PCI.","time_frame":"within 24 hours","description":"The left anterior descending (LAD) artery will be analyzed in a 30º right anterior oblique view with 30º cranial angulation. The left circumflex (LCX) will be analyzed in a 30º right anterior oblique view with 30º caudal angulation. The right coronary artery (RCA) will be analyzed in a 45º left anterior oblique view."},{"outcome_type":"primary","measure":"TIMI myocardial perfusion grade (TMPG) after PCI","time_frame":"within 24 hours","description":"Grade 0: no contrast entering the myocardium; Grade 1: the contrast enters myocardium slowly, with myocardial staining not disappearing or lasting for more than 30 s in the targeted vessels; Grade 2: delayed entering and disappearing of contrast in the myocardium, exceeding 3 cardiac cycles; Grade 3: normal entering and disappearing of contrast in the myocardium, occurring within 3 cardiac cycles."},{"outcome_type":"primary","measure":"Percentage of ST-segment resolution on ECG (electrocardiogram) at 90 min after PCI","time_frame":"90 minutes","description":"ST-resolution is defined as more than 50% of resolution."},{"outcome_type":"primary","measure":"Number of cardiovascular events within 30 d after PCI","time_frame":"30 days","description":"Cardiovascular events included all-cause death, cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and hospitalization due to heart failure."},{"outcome_type":"primary","measure":"SOD (Superoxide Dismutase) activity","time_frame":"0 hours, 6 hours, 12 hours, 24 hours, 48 hours, 72 hours and 7 days after surgery","description":"Change from Baseline SOD activity at 6h, 12h, 24h, 48h, 72h and 7 d after surgery."},{"outcome_type":"primary","measure":"Occurence of adverse events","time_frame":"During patient hospitalization, up to 30 days","description":"Occurence of adverse events"},{"outcome_type":"primary","measure":"Cardiac function at 30 d after PCI","time_frame":"30 days","description":"Cardiac function is assessed by assessing the left ventricular ejection fraction (percentage of stroke output to end-diastolic volume)."}]}
{"nct_id":"NCT03990246","start_date":"2019-06-12","phase":"N/A","enrollment":15,"brief_title":"Emulsion Lipid Digestion & Satiety Study - Effect of Physical State and Acid Stability","official_title":"Impact of Emulsion Droplet Physical Properties on Postprandial Lipemia and Satiety in Healthy Adult Males","primary_completion_date":"2020-03-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-08-31","last_update":"2020-10-27","description":"The purpose of this study is to compare the changes in blood lipids and feelings of satiety after consumption of acid stable or acid unstable oil-in-water emulsions in which the droplets are in either the liquid or partially solid (i.e. crystalline) states.","other_id":"19-04-003","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Basic Science","masking_description":"Double","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  BMI of 18 - 26 kg/m2\r\n\r\n          -  generally healthy\r\n\r\n          -  non-smoking\r\n\r\n          -  non to moderate alcohol drinkers\r\n\r\n          -  fasting plasma cholesterol level <5.2 mmol/L\r\n\r\n          -  plasma triacylglycerol level <1.7 mmol/L\r\n\r\n          -  plasma glucose level <5.6 mmol/L\r\n\r\n          -  no history of gastric surgeries\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of major medical conditions\r\n\r\n          -  taking prescription medications/ over the counter medications\r\n\r\n          -  taking natural health products/ dietary supplements (other than a multivitamin)\r\n\r\n          -  oral antibiotic use in the previous 3 months\r\n\r\n          -  planning to take oral antibiotics in the next 3 months\r\n\r\n          -  food allergy/anaphylactic/life-threatening allergy\r\n\r\n          -  smokers/ regular users of recreational drugs\r\n\r\n          -  elite/ training athletes\r\n\r\n          -  significant weight loss/ gain during the past 3 months\r\n\r\n          -  previous reaction/ sensitivity to acetaminophen\r\n\r\n          -  inability to avoid taking acetaminophen for 48 hours\r\n\r\n          -  sensitivity to the artificial sweetener Sugar Twin Sucralose and artificial vanilla\r\n             extract\r\n\r\n          -  not willing to consume Sugar Twin Sucralose or Artificial vanilla.\r\n      ","sponsor":"University of Guelph","sponsor_type":"Other","conditions":"Healthy","interventions":[{"intervention_type":"Other","name":"Other: Acid stable emulsion with solid droplets","description":"This will be a 250 mL acid stable beverage emulsion in which the droplets are crystalline. It will have identical similar to the other intervention, i.e. in a set of samples the emulsion lipid droplets are in the liquid state and are either acid stable or unstable and, in the other set of samples they are solid (i.e. crystallized) and are also either acid stable or unstable in the acidic environment of the stomach, and will be introduced at least 7 days apart. The emulsion will contain 20% of the lipid palm stearin with 2.2% of the emulsifier sorbitan monooleate (Tween80)"},{"intervention_type":"Other","name":"Other: Acid stable emulsion with liquid droplets","description":"This will be a 250 mL acid stable beverage emulsion in which the droplets are liquid. It will have identical similar to the other intervention, i.e. in a set of samples the emulsion lipid droplets are in the liquid state and are either acid stable or unstable and, in the other set of samples they are solid (i.e. crystallized) and are also either acid stable or unstable in the acidic environment of the stomach, and will be introduced at least 7 days apart. The emulsion will contain 20 % of the lipid palm olein with 2.2% of the emulsifier sorbitan monooleate (Tween80)"},{"intervention_type":"Other","name":"Other: Acid unstable emulsion with solid droplets","description":"This will be a 250 mL acid unstable beverage emulsion in which the droplets are solid. It will have identical similar to the other intervention, i.e. in a set of samples the emulsion lipid droplets are in the liquid state and are either acid stable or unstable and, in the other set of samples they are solid (i.e. crystallized) and are also either acid stable or unstable in the acidic environment of the stomach, and will be introduced at least 7 days apart. The emulsion will contain 20% of the lipid palm stearin with 2.5% of the emulsifier sorbitan monostearate (Span60)"},{"intervention_type":"Other","name":"Other: Acid unstable emulsion with liquid droplets","description":"This will be a 250 mL acid unstable beverage emulsion in which the droplets are liquid. It will have identical similar to the other intervention, i.e. in a set of samples the emulsion lipid droplets are in the liquid state and are either acid stable or unstable and, in the other set of samples they are solid (i.e. crystallized) and are also either acid stable or unstable in the acidic environment of the stomach, and will be introduced at least 7 days apart. The emulsion will contain 20 % of the lipid palm olein with 2.5% of the emulsifier sorbitan monostearate (Span60)"}],"outcomes":[{"outcome_type":"primary","measure":"Changes in triacylglycerol blood concentrations","time_frame":"6 hours","description":"Based on determination of fasting and postprandial blood triacylglycerol concentration (mmol/L)"},{"outcome_type":"secondary","measure":"Participant visual analogue scale ratings of feelings of satiety","time_frame":"6 hours","description":"Visual analogue scale ratings of feelings of hunger, fullness, appetite, prospective food consumption, desire to eat, and nausea after consuming the emulsion beverage. 0: not hungry, empty, no appetite, very little food, no desire to eat and no nausea, and 10: very hungry, very full, high appetite, a lot of food, very strong desire to eat and very nauseated. The distance from the left end of the scale will be measured (cm)"},{"outcome_type":"secondary","measure":"Rate of gastric emptying by measuring the changes in acetaminophen blood concentrations","time_frame":"6 hours","description":"The rate of appearance of acetaminophen (consumed crushed in water immediately after test meal) in the plasma will be determined (mg/L)"},{"outcome_type":"secondary","measure":"Changes in fatty acid concentration of blood triacylglycerols","time_frame":"6 hour","description":"Analysis based on fasting and postprandial blood sample analysis (mmol/L)"},{"outcome_type":"secondary","measure":"Changes in satiety hormone blood concentrations","time_frame":"6 hours","description":"Analysis of blood for Ghrelin, Leptin, GLP-1,PYY, GIP, and Insulin, at fasting and postprandially (pg/mL)"},{"outcome_type":"secondary","measure":"Changes in concentrations of inflammatory blood markers (ug/mL)","time_frame":"6 hours","description":"Analysis of blood for CD14 and LBP at fasting and postprandially"},{"outcome_type":"secondary","measure":"Rate of gastric emptying by measuring the change in the gastric antrum area","time_frame":"6 hours","description":"Determined by measuring the cross-sectional area of the gastric antrum using ultrasound (cm*cm)"},{"outcome_type":"secondary","measure":"Changes in glucose blood concentrations","time_frame":"6 hour","description":"Based on determination of fasting and postprandial blood glucose (mg/dL)"}]}
{"nct_id":"NCT03984110","start_date":"2019-06-11","phase":"Phase 4","enrollment":50,"brief_title":"The Use of a Combination of Ozurdex and Eylea Versus Eylea Monotherapy for Diabetic Macular Edema: A Prospective, Comparative Trial (COED Trial)","official_title":"The Use of a Combination of Ozurdex and Eylea Versus Eylea Monotherapy for Diabetic Macular Edema: A Prospective, Comparative Trial (COED Trial)","primary_completion_date":"2020-06-15","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2021-06-15","last_update":"2019-06-12","description":"The Use of a Combination of Ozurdex and Eylea Versus Eylea Monotherapy for Diabetic Macular Edema","other_id":"TRA-COED-19-001","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Type 1 or 2 diabetic patients\r\n\r\n          2. At least 18 years of age, understands the language of the informed consent, and is\r\n             willing and able to provide written informed consent before any study procedures\r\n\r\n          3. Pseudophakic or phakic lens status with intact posterior lens capsule and/or Nd:YAG\r\n             laser capsulotomy that in the investigator's opinion is not likely to permit\r\n             dislocation of Ozurdex implant into the anterior chamber\r\n\r\n          4. Center-involving DME > 300 m\r\n\r\n          5. Baseline BCVA between 20/40 - 20/320\r\n\r\n          6. Eyes with intraocular pressure (IOP)  21 and / or treatment with < 2 topical\r\n             IOP-lowering medications (eyes with history of previous angle -closure or similar\r\n             conditions that have been successfully treated with either laser or surgical\r\n             intervention are allowed as long as the visual fields and optic nerves have been\r\n             stable for > 1 year prior to study entry and the patient has been and can be safely\r\n             dilated)\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients with active or suspected ocular or periocular infections including most viral\r\n             diseases of the cornea and conjunctiva, including active epithelial herpes simplex\r\n             keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and\r\n             fungal diseases.\r\n\r\n          2. Patients with known hypersensitivity to any components of Eylea or Ozurdex\r\n\r\n          3. Patient has suffered from a stroke or transient ischemic attack (TIA) in the last 6\r\n             months\r\n\r\n          4. Patients using topical anti-inflammatory medication for the duration of the study\r\n\r\n          5. Patients with ACIOL (Anterior Chamber Intraocular Lens) and rupture of the posterior\r\n             lens capsule\r\n\r\n          6. Prior panretinal photocoagulation or macular laser treatments within 90 days of\r\n             screening\r\n\r\n          7. Previous vitrectomy\r\n\r\n          8. Any ocular condition that in the opinion of the investigator would not permit\r\n             improvement of visual acuity with resolution of DME (e.g., foveal atrophy, pigment\r\n             abnormalities, dense subfoveal hard exudates and/or poor foveal architecture\r\n             suggestive of photoreceptor loss)\r\n\r\n          9. Patients with retinal diseases other than diabetes that can affect macular edema\r\n\r\n         10. Eyes with a history of advanced glaucoma (optic nerve head change consistent with\r\n             glaucoma damage and/or glaucomatous visual field loss), uncontrolled ocular\r\n             hypertension (baseline IOP > 21 mmHg despite use of  2 topical IOP-lowering\r\n             medication)\r\n\r\n         11. Eyes with a history of steroid response (i.e., increase of  5 mmHg IOP following\r\n             topical steroid treatment)\r\n\r\n         12. Female patients who are pregnant or breastfeeding\r\n\r\n         13. Patients who are unable to attend scheduled follow-up visits throughout the 24-week\r\n             study\r\n\r\n         14. Any intravitreal anti-VEGF treatment to study eye within 3 months prior to Day 1\r\n\r\n         15. Use of systemic steroid, anti-VEGF or pro-VEGF treatment within 4 months prior to\r\n             enrollment or anticipated use during the study (these drugs are prohibited from use\r\n             during the study)\r\n\r\n         16. History of any previous treatment in the study eye with an ocular corticosteroid\r\n             implant (eg Iluvien, Ozurdex, Retisert)\r\n\r\n         17. Has scarring from laser photocoagulation in the study eye that would compromise VA; or\r\n             scarring or abnormality from other macular condition, in the investigator's medical\r\n             judgement, would limit VA (such as an epiretinal membrane or macular hole)\r\n\r\n         18. Has significant media opacity precluding evaluation of retina and vitreous in the\r\n             study eye. This includes cataract that is felt to be a major contributor to reduced\r\n             visual acuity and/or likely to undergo surgical repair within 3 months of\r\n             randomization.\r\n\r\n         19. Has any uncontrolled systemic disease that, in the opinion of the Investigator, would\r\n             preclude participation in the study (eg, infection, uncontrolled elevated blood\r\n             pressure, cardiovascular disease, poor glycemic control) or put the subject at risk\r\n             due to study treatment or procedures\r\n\r\n         20. Has had a myocardial infarction, other acute cardiac event requiring hospitalization,\r\n             stroke, transient ischemic attack, or treatment for acute congestive heart failure\r\n             within 1 month before enrollment\r\n      ","sponsor":"Texas Retina Associates","sponsor_type":"Other","conditions":"Diabetic Macular Edema","interventions":[{"intervention_type":"Drug","name":"Drug: Ozurdex","description":"Intravitreal injection"},{"intervention_type":"Drug","name":"Drug: Eylea","description":"Intravitreal injection"}],"outcomes":[{"outcome_type":"primary","measure":"Central Subfield Thickness","time_frame":"48 weeks","description":"Change in Central Subfield Thickness on OCT"},{"outcome_type":"secondary","measure":"Central Subfield Thickness","time_frame":"12 weeks, 24 weeks, and 36 weeks","description":"Change in Central Subfield Thickness"},{"outcome_type":"secondary","measure":"Best Corrected Visual Acuity","time_frame":"12 weeks, 24 weeks, 36 weeks, and 48 weeks","description":"Change in Best Corrected Visual Acuity"},{"outcome_type":"secondary","measure":"Number of additional IVT aflibercept injections required over 48 weeks","time_frame":"48 weeks","description":"Number of additional IVT aflibercept injections required over 48 weeks"},{"outcome_type":"secondary","measure":"Monthly mean changes from baseline in BCVA","time_frame":"48 weeks","description":"Monthly mean changes from baseline in BCVA as measured by ETDRS letters read"},{"outcome_type":"secondary","measure":"Monthly mean changes from baseline in CST","time_frame":"48 weeks","description":"Monthly mean changes from baseline in CST as measured by SD-OCT"}]}
{"nct_id":"NCT03979196","start_date":"2019-06-06","phase":"N/A","enrollment":134,"brief_title":"Inpatient vs Outpatient Management of Short Cervix","official_title":"Inpatient vs Outpatient Management of Women With Short Cervix: A Randomized Controlled Trial (RCT)","primary_completion_date":"2021-03-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2021-03-31","last_update":"2019-10-01","description":"The presence of short cervix during pregnancy is a risk factor for preterm birth though in many cases women will eventually deliver at term or near term. While there are proven treatments such as cerclage and progesterone that can improve pregnancy outcomes, many women are advised to limit their activity, are put on bed rest, or admitted to hospital for inpatient management. Presently, there is no evidence that hospital admission of women with short cervix is beneficial and prolongs the pregnancy. The investigators propose to examine whether inpatient management results in comparable outcomes to outpatient management for women with short cervix.","other_id":"ShortCxTrial","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Singleton pregnancy between 23 weeks 0 days - 28 weeks 6 days gestational age\r\n\r\n          -  SC (1.5cm) determined by TVS\r\n\r\n          -  Vaginal progesterone treatment\r\n\r\n          -  Cervical dilatation of 1cm\r\n\r\n          -  Located within 45 minute drive from recruitment site (Sunnybrook Health Sciences\r\n             Centre or North York General Hospital)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Multiple pregnancy\r\n\r\n          -  Preterm premature rupture of membranes (PPROM), vaginal bleeding, infection, high\r\n             blood pressure (defined as 140/90 mm Hg or higher)\r\n\r\n          -  Regular uterine contractions or active labour\r\n\r\n          -  Vaginal bleeding\r\n\r\n          -  Cervical dilatation of >1cm\r\n\r\n          -  Fetal anomalies\r\n      ","sponsor":"Sunnybrook Health Sciences Centre","sponsor_type":"Other","conditions":"Preterm Birth|Pregnancy, High Risk","interventions":[{"intervention_type":"Other","name":"Other: Inpatient Management","description":"Admission for a minimum of three days, administration of betamethasone, and clinical reassessment by obstetrician after three days. After the initial three day admission, further management will be at the discretion of their obstetrician who will continue their care and decide if further admissions are needed.\r\nWeekly cervical length assessment will be performed until 28 weeks and patient readmission will be decided by their Obstetrician.\r\nPost-intervention, women in both arms will receive the same standard of care (weekly clinic or inpatient follow-up appointments) and will be followed to delivery. Prior to delivery, participants will complete a patient Quality of Life survey and at delivery, primary and secondary outcomes will be collected."},{"intervention_type":"Other","name":"Other: Outpatient Management","description":"Avoid heavy lifting and core exercise, avoid intercourse, weekly assessment of cervical length by ultrasound and administration of betamethasone. Patients will continue with outpatient management for the remainder of their pregnancy with no admission unless the patient develops contractions, PPROM, bleeding, or the cervix is dilated to 1cm.\r\nPost-intervention, women in both arms will receive the same standard of care (weekly clinic or inpatient follow-up appointments) and will be followed to delivery. Prior to delivery, participants will complete a patient Quality of Life survey and at delivery, primary and secondary outcomes will be collected."}],"outcomes":[{"outcome_type":"primary","measure":"Gestational age at delivery","time_frame":"At delivery"},{"outcome_type":"secondary","measure":"Betamethasone treatment","time_frame":"Before delivery"},{"outcome_type":"secondary","measure":"Magnesium sulphate treatment","time_frame":"Before 32 weeks gestation"},{"outcome_type":"secondary","measure":"Intrapartum complications","time_frame":"During delivery","description":"Any of the following: cord prolapse, postpartum hemorrhage, or fetal distress"},{"outcome_type":"secondary","measure":"Mode of delivery","time_frame":"At delivery","description":"One of: vaginal delivery, caesarean section, operative delivery"},{"outcome_type":"secondary","measure":"Patient Quality of Life","time_frame":"1 week after randomization","description":"36-Item Short Form Health Survey: 36-item, self-administered survey takes 5 minutes and is designed to measure health on eight multi-item dimensions, including functional status, well-being, and overall evaluation of health."},{"outcome_type":"secondary","measure":"Neonatal morbidity and mortality: composite measure","time_frame":"1-28 days post-delivery","description":"A composite of the following: Early-onset sepsis/meningitis (culture proven within first 7 days of life), Significant Intraventricular hemorrhage (IVH) (Grade III/IV, hemorrhagic venous infarct), Periventricular leukomalacia (PVL), Respiratory distress syndrome (RDS) (requiring surfactant and ventilation), Need for high frequency oscillatory ventilation (HFO) on Day 1, Need for inhaled nitric oxide (iNO) on Day 1, Pneumothorax (requiring needle aspiration or chest tube drainage), Chronic lung disease (requiring oxygen at discharge/transfer or at corrected gestational age (CGA) 36 weeks), Death, retinopathy of prematurity(ROP) (>Stage 2), necrotizing enterocolitis (NEC) (finding of pneumatosis, portal vein gas or free peritoneal air on abdominal radiograph), patent ductus arteriosus (PDA) (presence of PDA diagnosed by echocardiography or clinical suspicion treated with medication or surgery)"}]}
{"nct_id":"NCT03855449","start_date":"2019-06-05","phase":"N/A","enrollment":11,"brief_title":"A Task Analysis Study of DECIDE For African American Patients With Type 2 Diabetes","official_title":"Web-Based Problem Solving Self-Management Program for African Americans With Type 2 Diabetes","primary_completion_date":"2022-10-30","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2023-01-31","last_update":"2021-05-10","description":"The DECIDE program is a problem-solving curriculum used to help manage everyday problems when living with diabetes. The purpose of this project is to complete an in-depth review of the Decision-Making Education for Choices in Diabetes Every Day (DECIDE) curriculum, which is delivered in a group face-to-face setting. Using a task analysis process, the investigators will use the findings from the review to develop a web-site version.","other_id":"STUDY00141460","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","intervention_model_description":"A single group will be recruited to go through the in-person DECIDE problem-solving curriculum","sampling_method":"","gender":"All","minimum_age":16,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  African American\r\n\r\n          -  English speaking\r\n\r\n          -  Access to the Internet daily\r\n\r\n          -  Reading level of at least 5th grade\r\n\r\n          -  Diagnosis of Type 2 Diabetes per one of the following\r\n\r\n               1. Fasting blood glucose  to 126 mg/dL\r\n\r\n               2. 2 hr plasma glucose  200 mg/dL\r\n\r\n               3. Glycosylated hemoglobin HbA1c  to 6.5%\r\n\r\n               4. Random plasma glucose  200 mg/dL\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Glycosylated hemoglobin HbA1c  7.0\r\n\r\n          -  Pregnancy\r\n\r\n          -  Severe visual or hearing impairment or any existing condition that would limit or\r\n             hinder one's ability to use the Internet\r\n\r\n          -  Dementia\r\n\r\n          -  Use of supplemental oxygen\r\n\r\n          -  Chest pain or angina\r\n\r\n          -  Prior lower extremity amputation\r\n\r\n          -  A diagnosis of a life threatening malignancy within the past year\r\n      ","sponsor":"University of Kansas Medical Center","sponsor_type":"Other","conditions":"Diabetes Mellitus, Type 2","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Task Analysis Intervention Group","description":"Will conduct 9 week in-person group sessions of the DECIDE curriculum with recruited volunteers. This is part 1 or phase I of the eventual pilot clinical trial. Participants will attend weekly group sessions to learn problem-solving skills and management of their diabetes."}],"outcomes":[{"outcome_type":"primary","measure":"Task Analysis study process chart","time_frame":"15 weeks","description":"First output of the task analysis is a process chart of conducting the DECIDE program, using video tapped sessions of DECIDE"},{"outcome_type":"primary","measure":"Task Analysis Wireframe Development part 1","time_frame":"15 weeks","description":"Second output of the task analysis is a task flow diagram of facilitation and participant responses using case scenarios by user group."},{"outcome_type":"primary","measure":"Task Analysis Wireframe Development part 2","time_frame":"15 weeks","description":"Third output of the task analysis is a task decomposition table of the DECIDE curriculum, breaking down the task/actions of facilitator and participant into smaller task for replicating on the website"}]}
{"nct_id":"NCT03931525","start_date":"2019-06-01","phase":"N/A","enrollment":32,"brief_title":"Effect of Radiofrecuency on Stretch Marks","official_title":"Effect of Fractional Radiofrecuency Associated Cosmetology Derug Delivery in Treatment of Strech Marks","primary_completion_date":"2019-11-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-05-01","last_update":"2020-06-09","description":"This study aims to explore the effects of fractional Radiofrecuency (RF), as well as demonstrate the performance of the new semi-ablative radiofrequency model in the treatment of stretch marks. This research is a randomized, controlled clinical trial where 32 female patients complaining of glutes and / or abdomen striations. The participants were divided into two equal groups, G1 and G2. G1 will be treated at 30-day intervals, and subdivided into 2 subgroups: G1A, 8 patients with striations in the abdomen; and G1B, 8 patients with gluteal striations. The G1A and G1B groups will be divided into 2 subgroups of 4 people each, where one group will be treated with Fractional RF associated to drug delivery, and the other group, with only Fractional RF, without the application of drug delivery. The same rule of subdivisions will occur in G2, G2A and G2B, however, the interval between applications will be every 15 days. The treatment area will be divided into a rectangle 10cm high by 10cm wide. For evaluation, the contralateral side will be used as a control, using Photogrammetry and histological analysis as a resource, which will be collected through the punch skin fragment of the infraumbilical and gluteal region, performed by a specialized physician.","other_id":"8042019","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Women over 18 and not older than 45 years\r\n\r\n          -  Presence Gluteal and Abdominal Striae.\r\n\r\n          -  Stretch marks aesthetic discomfort\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Malignancy.\r\n\r\n          -  Metal implants or abdominal or pelvic stents\r\n\r\n          -  Presence of collagen diseases.\r\n\r\n          -  Alteration in the synthesis of proteins.\r\n\r\n          -  Alterations of the integrity of the skin such as burns, wounds, keloids, hypertrophic\r\n             scars or dermatitis.\r\n\r\n          -  Intake of steroidal and nonsteroidal anti-inflammatory drugs.\r\n\r\n          -  Hypocaloric diet indicated by nutritionist.\r\n\r\n          -  Do not agree with the intervention protocol.\r\n\r\n        Elimination Criteria\r\n\r\n          -  Non-tolerance of the intervention with electrotherapy that requires the suspension of\r\n             treatment.\r\n\r\n          -  Non-completion of the evaluation protocol (Attendance at all scheduled sessions).\r\n      ","sponsor":"Quiropraxia y Equilibrio","sponsor_type":"Other","conditions":"Stretch Marks","interventions":[{"intervention_type":"Device","name":"Device: Fractitional Radiofrecuency","description":"Electromagnetic energy within the spectrum of radio frequencies applied to the skin whose purpose is to generate thermal effects"},{"intervention_type":"Device","name":"Device: Fractitional Radiofrecuency with Drug Delivery","description":"Electromagnetic energy within the spectrum of radio frequencies applied to the skin whose purpose is to generate thermal effects and which will be complemented with a skin drug"}],"outcomes":[{"outcome_type":"primary","measure":"Histological changes in stretch marks","time_frame":"a period of 30 days or 15 days post intervention","description":"Analysis with electronic microscopy of the percentage increase or decrease in the type and amount of collagen, as well as circulatory changes."}]}
{"nct_id":"NCT04996186","start_date":"2019-06-01","enrollment":200,"brief_title":"Symptoms and Treatment Assessment of Ano-Rectal Disorders in Multiple Sclerosis Patients : STAR-Q","official_title":"Symptoms and Treatment Assessment of Ano-Rectal Disorders in Multiple Sclerosis Patients : STAR-Q (STAR Questionnaire): Validation of a New Tool to Better Explore and Manage Bowel Dysfunction.","primary_completion_date":"2020-07-01","study_type":"Observational","rec_status":"Completed","completion_date":"2021-04-30","last_update":"2021-08-27","description":"Multiple sclerosis (MS) is known to cause urinary disorders, sexual and bowel dysfunction. Urinary symptoms due to MS are well known and profit of multiple questionnaire or tool developed in MS patients. Prevalence of bowel disorders in MS is difficult to assess. Some studies up to 70% bowel disorders in MS patients. Constipation and fecal incontinence are the two main symptoms in neurogenic bowel dysfunction and frequently coexist in this population, generally in association with urinary disorders. Because of the high prevalence of bowel disorders their and the major impact on the quality of life of patients with Multiple sclerosis (PwMS) , and the cross-talk bladder-rectum (persistence of anorectal dysfunction leading to poor neurogenic bladder control) assessment of bowel disorders in MS is necessary. But this evaluation is difficult as no specific score exist. The neurogenic Bowel Dysfunction score (NBD) is often used. The NBD was developed and validated for spinal cord injury (SCI) population but not for PwMS MS. Yet NBD is often used in research for all neurologic patients despite its lack of sensibility in various neurogenic population other than spinal cord injury patient. As recommended in a Cochrane revue in 2014, there is a need of a specific evaluation for bowel symptoms in neurogenic population, especially for PwMS. The aim of the study was to create and validate a new multidimensional questionnaire to assess bowel dysfunction and impact on quality of life in patients with MS. The investigators conducted a prospective multicenter study (8 centers) between June 2019 to April 2021. This study was developed in 3 steps. First step was literature review and qualitative interview. Then the second step was the feasibility study to evaluate comprehension, acceptability of the different items. The last part of the study was the validation study of the questionnaire. This part of the study was performed between June2020 and April 2021. Validation study allowed to determine the psychometric properties of the new tool. Patients aged over 18 years with multiple sclerosis diagnosed on the 2017 revised McDonald's criteria were included. Patients not able to read or understand the objectives and procedures for conducting the protocol and patient who had a recent relapse of MS were excluded.","other_id":"GRC 01 GREEN STAR Q","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients consulting or hospitalized in a rehabilitation center or in a neuro-urology center","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with multiple sclerosis diagnosed on the 2017 revised McDonald's criteria\r\n\r\n          -  over 18 years old\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  inability to read and to understand the questions\r\n\r\n          -  recent relapse of multiple sclerosis\r\n      ","sponsor":"Pierre and Marie Curie University","sponsor_type":"Other","conditions":"Multiple Sclerosis|Constipation|Fecal Incontinence","interventions":[{"intervention_type":"Other","name":"Other: Clinical interviews","description":"Semi-qualitative interviews and questionnaire STAR-Q"}],"outcomes":[{"outcome_type":"primary","measure":"Reproductibility of STAR-Q","time_frame":"1 day","description":"Patients were asked to answer a second time the questionnaire with a second evaluation at 14 days after the first one. The \"intra-class correlation coefficient\" (ICC) was used to determine if these evaluations could lead to similar results for each question. An ICC > 0.70 was necessary to define reproducibility."},{"outcome_type":"primary","measure":"Acceptability and comprehension of STAR-Q","time_frame":"1 day","description":"Each patient was asked to rate each version of the 22 questions with a four-point Likert scale (A: perfect, B: good, C: average, D: bad) regarding acceptance and comprehension of the questions."}]}
{"nct_id":"NCT04539028","start_date":"2019-06-01","enrollment":300,"brief_title":"Emergency General Surgery for Non-trauma","official_title":"Emergency General Surgery for Non-trauma - A Prospective Observational Study","primary_completion_date":"2022-05-30","study_type":"Observational","rec_status":"Recruiting","completion_date":"2022-05-30","last_update":"2020-09-04","description":"This study will observe the postoperative morbidity and mortality trends in patients with non- traumatic abdominal pathology who will undergo emergency general surgery. This prospective study will help us in establishing a prospective de-identified registry that may be used to further research this cohort in the future.","other_id":"12811","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":99,"population":"All adult patients ages 18-99, regardless of sex, racial or ethnic background who will\r\n        undergo or underwent emergency abdominal surgery","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  All adult patients ages 18-99, regardless of sex, racial or ethnic background who will\r\n             undergo or underwent emergency abdominal surgery for acute abdomen due to perforated\r\n             viscus, acute bowel obstruction, bowel ischemia, acute or gangrenous gall bladder,\r\n             post-operative complications such as anastomotic leaks after bowel\r\n             anastomosis,abdominal compartment syndrome,enterocutaneous/enteroatmospheric fistula\r\n             or bleeding.\r\n\r\n          -  Investigators will also include patients after organ transplant that will undergo\r\n             emergent surgery for post-operative bleeding, anastomotic leak or organ ischemia.\r\n\r\n          -  As well as any patients undergoing bariatric surgery or colorectal procedures that\r\n             develop any complication that might need return to the operating room emergently will\r\n             also be included in the study from 2019 at Westchester Medical Center.\r\n\r\n             3. Key Exclusion Criteria\r\n\r\n          -  Elective delayed repair for surgery done after clinic follow-up.\r\n\r\n          -  Age < 18 years or greater than 89 years of age\r\n      ","sponsor":"New York Medical College","sponsor_type":"Other","conditions":"Bowel Obstruction","interventions":[{"intervention_type":"Procedure","name":"Procedure: Emergency Abdominal surgery","description":"Emergency Abdominal surgery"}],"outcomes":[{"outcome_type":"primary","measure":"morbidity and mortality","time_frame":"1 year","description":"The objective of this study is to analyze postoperative outcomes as well as morbidity and mortality trends for this sick cohort of patients with non- traumatic abdominal pathology who will undergo emergency general surgery."}]}
{"nct_id":"NCT03942094","start_date":"2019-06-01","phase":"Phase 3","enrollment":100,"brief_title":"Nilotinib for First-line Newly Diagnosed CML-CP Patients","official_title":"Efficacy and Safety of Nilotinib as the First-line Treatment for Patients With Newly Diagnosed Chronic-phase Chronic Myeloid Leukemia: a Prospective Study","primary_completion_date":"2023-06-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-12-01","last_update":"2020-11-13","description":"This is a phase IIIb, multi-centre, single-arm, open-label, prospective study investigating the efficacy and safety of nilotinib as the first-line treatment for the adult patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML-CP) in China. Nilotinib 300 mg BID will be provided in this study. The assessment for the primary efficacy endpoint will be performed at 18 months and the rate of patients obtaining MR4.5 will be measured at this time point. Secondary endpoints include the complete hematologic response(CHR) and the rates of major molecular reactions (MMR) by 3, 6, 9,12,18 and 24 months; event free survival (EFS); overall survival (OS).","other_id":"Nilotinib20190426","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male and female patients\r\n\r\n          -  Newly diagnosed CP-CML within 6 months prior to study entry, positive Philadelphia\r\n             chromosome or positive BCR-ABL (M-bcr transcript)\r\n\r\n          -  Age  18 years old (no upper age limit given)\r\n\r\n          -  CML-CP defined by primordial cells in peripheral blood or bone marrow <20%, basophils\r\n             in peripheral blood <20%, platelets 100 x 109/L(100,000/mm3), except for\r\n             hepatosplenomegaly\r\n\r\n          -  Patient for whom treatment with Imatinib within 2 weeks is expected No other CML\r\n             treatment except for hydroxyurea and/or anagrelide and/or IFN ECOG score 0 to 2\r\n\r\n          -  Organ function defined by total serum bilirubin levels < 1.5  the upper limit of the\r\n             normal range (ULN), SGOT and SGPT < 2.5 UNL, creatinine < 1.5  ULN, amylase and\r\n             lipase  1.5  ULN and alkaline phosphatase  2.5  ULN not directly related to the\r\n             CML\r\n\r\n          -  Laboratory values defined by potassium  LLN, magnesium  LLN, phosphate  LLN, total\r\n             calcium (correction for serum albumin)  LLN\r\n\r\n          -  No planned allogeneic stem cell transplantation\r\n\r\n          -  Signed informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients confirmed to have a T315I mutation\r\n\r\n          -  TKIs are not allowed to be treated prior to entering the study, unless the patient has\r\n             an emergency pending the start of the study, and any dose of commercial imatinib may\r\n             be used to the patient, but no more than 2 weeks\r\n\r\n          -  Treatment with IFN for more than 3 mouths\r\n\r\n          -  Impaired cardiac function including any of the following:\r\n\r\n               1. Complete left bundle branch block\r\n\r\n               2. Right bundle branch block plus left anterior hemiblock,bifascicular block\r\n\r\n               3. Use of a ventricular-paced pacemaker\r\n\r\n               4. Congenital long QT syndrome\r\n\r\n               5. Clinically significant ventricular or atrial tachyarrhythmias\r\n\r\n               6. Clinically significant resting bradycardia (<50 beats per minute)\r\n\r\n               7. QTcF >450 msec on screening ECG.If QTcF >450 msec and electrolytes are not within\r\n                  normal ranges before nilotinib dosing, electrolytes should be corrected and then\r\n                  the patient rescreened for QTcF criterion\r\n\r\n               8. Myocardial infarction within 12 months prior to starting nilotinib\r\n\r\n               9. Other clinical significant heart disease (e.g. unstable angina,congestive heart\r\n                  failure,uncontrolled hypertension)\r\n\r\n          -  Patients who are confirmed CNS infiltration by cytopathology\r\n\r\n          -  Concurrent uncontrolled medical conditions (e.g. uncontrolled diabetes, active or\r\n             uncontrolled infections)\r\n\r\n          -  Congenital or acquired bleeding tendency\r\n\r\n          -  Patients who have undergone major surgery  4 weeks prior to starting study drug or\r\n             who have not recovered from side effects of such therapy\r\n\r\n          -  Received other study medications within 30 days (defined as drugs that cannot be used\r\n             based on approved indications)\r\n\r\n          -  Patients unwilling or unable to comply with the protocol\r\n\r\n          -  Patients with a history of another primary malignancy that is currently clinically\r\n             significant or currently requires active intervention\r\n\r\n          -  Concomitant medications known to be strong inducers or inhibitors of the CYP450\r\n             Isoenzyme CYP3A4 (for example, erythromycin, ketoconazole, itraconazole, voriconazole,\r\n             clarithromycin, telithromycin, ritonavir, and midazolam)\r\n\r\n          -  Impaired gastrointestinal function or disease that may alter the absorption of study\r\n             drug (e.g.ulcerative disease,uncontrolled nausea,vomiting and diarrhea,malabsorption\r\n             syndrome,small bowel resection or gastric by-pass surgery)\r\n\r\n          -  History of acute pancreatitis within 12 months or chronic pancreatitis\r\n\r\n          -  History of acute or chronic diseases of Liver, pancreas or kidney\r\n\r\n          -  Concomitant medications with potential QT prolongation\r\n\r\n          -  Patients who are pregnant or breast feeding or women of reproductive potential not\r\n             employing an effective method of birth control.Women of childbearing potential must\r\n             have a negative serum pregnancy test within 14 days prior to administration of\r\n             nilotinib.Post menopausal women must be amenorrheic for at least 12 months in order to\r\n             be considered of non-childbearing potential.Female patients must agree to employ an\r\n             effective barrier method of birth control throughout the study and for up to 3 months\r\n             following discontinuation of study drug\r\n      ","sponsor":"Shenzhen Second People's Hospital","sponsor_type":"Other","conditions":"Chronic Myeloid Leukemia, Chronic Phase|Nilotinib","interventions":[{"intervention_type":"Drug","name":"Drug: Nilotinib","description":"Nilotinib (Tasigna ), capsules of 150 mg\r\nNilotinib 2 capsules of 150 mg, orally, twice daily"}],"outcomes":[{"outcome_type":"primary","measure":"Molecular response (MR) 4.5 at 18 months of nilotinib 300 mg twice a day","time_frame":"18 months"},{"outcome_type":"secondary","measure":"Molecular Response 4.5 at 3, 6, 9, 12, 24 months of nilotinib","time_frame":"24 months"},{"outcome_type":"secondary","measure":"Major Molecular Response at 3, 6, 9, 12, 24 months of nilotinib","time_frame":"24 months"},{"outcome_type":"secondary","measure":"Rate of CCyR (complete cytogenetic responses: bone marrow Philadelphie positive at 0 % on at least 20 metaphases) at 3, 6, 9, 12, 24 months of nilotinib.","time_frame":"24 months"},{"outcome_type":"secondary","measure":"Event-free survival","time_frame":"24 months","description":"Survival since randomization without any event defined as loss of CHR, loss of PCyR or CCyR, death from any cause, progression towards accelerated phase or blast crisis."},{"outcome_type":"secondary","measure":"Overall survival","time_frame":"24 months","description":"Survival without death from any cause"}]}
{"nct_id":"NCT03972852","start_date":"2019-06-01","enrollment":120,"brief_title":"Establishment of an Anaesthetic Protocol for Examinations for Children With Glaucoma or Suspected Glaucoma","official_title":"Establishment of an Anaesthetic Protocol for Examinations Under Anaesthesia for Children With Glaucoma or Suspected Glaucoma - Correlation of Bispectral Index (BIS) and Intraocular Pressure (IOP)","primary_completion_date":"2021-12-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2022-04-30","last_update":"2021-08-27","description":"Correct measurement of the intraocular pressure of children with glaucoma or suspected glaucoma is essential for diagnosis and therapy. Despite new non-invasive measurement methods most of the children are uncooperative during the ophthalmological examination. Therefore examination under anaesthesia is needed. A lot of perioperative factors influence the measurement of intraocular pressure. Established and safe anaesthetic regimes have been modified regarding these factors. Aim of the study is to evaluate, if a standardized anaesthetic protocol generates reliable and reproducible measured values.","other_id":"eyeBIS 1.0","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":0.41667,"maximum_age":10,"population":"Children with glaucoma or suspected glaucoma for ophthalmological examination or surgery","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Indication for a general anesthesia (laryngeal mask) and ophthalmological examination\r\n             and probably surgery\r\n\r\n          -  Children with glaucoma or suspected glaucoma\r\n\r\n          -  ASA classification I-III\r\n\r\n          -  written informed consent of the legal representatives\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Contraindication for a laryngeal mask airway\r\n\r\n          -  Known allergy to propofol or remifentanil\r\n      ","sponsor":"Johannes Gutenberg University Mainz","sponsor_type":"Other","conditions":"Anesthesia|Intraocular Pressure|Glaucoma, Suspect|Pediatric Glaucoma","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Correlation of depth of anesthesia an intraocular pressure","time_frame":"1 day","description":"The primary outcome measure is the association between intraocular pressure and bispectral index."},{"outcome_type":"secondary","measure":"Bland Altmann Correlation of Applanation tonometry and rebound tonometry","time_frame":"1 day","description":"Comparison of two different examination tools"},{"outcome_type":"secondary","measure":"Normal range of pediatric intraocular pressure","time_frame":"1 day","description":"Defining the normal range of pediatric intraocular pressure"},{"outcome_type":"secondary","measure":"Correlation of the corneal thickness and the intraocular pressure","time_frame":"1 day","description":"Regression"}]}
{"nct_id":"NCT03869424","start_date":"2019-05-27","phase":"N/A","enrollment":90,"brief_title":"Influence of Expectations on Rumination","official_title":"Influence of Expectations on Rumination: An Experimental Investigation","primary_completion_date":"2019-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-08-14","last_update":"2019-08-16","description":"The study tries to identify whether positive expectations, induced with an active placebo nasal-spray, have effects on rumination.","other_id":"2019-05k","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  healthy volunteers\r\n\r\n          -  fluent in German language\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  mental disorders\r\n\r\n          -  allergic to capsaicin\r\n\r\n          -  allergic to sesame oil\r\n\r\n          -  intake of psychopharmacological drugs in the last four weeks\r\n\r\n          -  intake of illegal drugs in the last two weeks\r\n\r\n          -  consumption of alcohol in the last twelve hours\r\n\r\n          -  students in medicine, pharmacy, or psychology\r\n\r\n          -  completed studies in medicine, pharmacy or psychology\r\n\r\n          -  current pregnancy or lactation\r\n\r\n          -  cardio vascular disease\r\n\r\n          -  kidney disease\r\n\r\n          -  liver disease\r\n      ","sponsor":"Philipps University Marburg Medical Center","sponsor_type":"Other","conditions":"Depression","interventions":[{"intervention_type":"Other","name":"Other: Active Placebo labelled as antidepessant","description":"Participants receive an active nasal spray that is in fact a placebo."}],"outcomes":[{"outcome_type":"primary","measure":"Change in State Rumination (Fragebogen zur Erfassung aktueller Ruminationsneigung)","time_frame":"At baseline and after the rumination induction. Each assessment is taking 5 Minutes, in total 10 minutes.","description":"German questionnaire of 10 Items, e.g.: \"I get lost in ruminative thoughts.\", \"I am present in this situation.\", \"My thoughts are focused on the past.\".All Items will be rated on a visual analogue scale from 0 (not at all) to 10 (very much)."},{"outcome_type":"primary","measure":"Change in Positive and Negative Affect Schedule (PANAS-X)","time_frame":"At baseline, after the negative biographical recall and after the rumination induction, each assessment is taking 3 minutes, in total 9 minutes.","description":"Items of PANAS-X: Sadness Score (\"sad\", \"blue\", \"downhearted\", \"alone\", \"lonely\") and Items \"Surprised\", \"concentrating\", \"happy\". All Items will be rated on a visual analogue scale from 0 (not at all) to 10 (very much)."}]}
{"nct_id":"NCT03981003","start_date":"2019-05-22","enrollment":1350,"brief_title":"Serum Neurofilament-light Chain and GFAP Levels in Patients From the OFSEP Cohort at Different Landmarks of Multiple Sclerosis","official_title":"Serum Neurofilament-light Chain and Glial Fibrillary Acidic Proten (GFAP) Levels in Patients From the OFSEP Cohort at Different Landmarks of Multiple Sclerosis","primary_completion_date":"2025-06-30","study_type":"Observational","rec_status":"Recruiting","completion_date":"2025-06-30","last_update":"2021-08-06","description":"The investigators hypothesize that serum neurofilament-light chain (NfL) levels can provide information about the level of activity and progression of Multiple Sclerosis at different stages and landmarks of the disease. In addition, Glial Fibrillary Acidic Protein (GFAP) has also been identified as another serum biomarker of disability in MS.","other_id":"CIVI/2018/ET-02","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":15,"population":"The study population is composed of consecutive patients over 15 years of age, of both\r\n        sexes, recruited during consultations for a CIS, RRMS or progressive MS at the Neurology\r\n        department of 30 OFSEP centres and of Nmes and Nantes University Hospitals. The patients\r\n        recruited will have an EDSS score comprised between 0 - 7.0.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  The patient has been correctly informed.\r\n\r\n          -  The patient must have given their informed and signed consent.\r\n\r\n          -  The patient must be insured or beneficiary of a health insurance plan.\r\n\r\n          -  The patient is at least ()15 years old.\r\n\r\n          -  The patient has MS according to diagnosis criteria (Thompson et al. 2017) and:\r\n\r\n               -  Participates to the OFSEP-HD cohort (ancillary study);\r\n\r\n               -  Has a Expanded Disability Status Scale score comprised between 0 - 7.0;\r\n\r\n               -  With or without Disease Modifying Drug;\r\n\r\n               -  For Work Package 3: patients enrolled in any OFSEP-HD centre that meet landmark\r\n                  criteria for an active MS (relapse, or Expanded Disability Status Scale\r\n                  progression, or active MRI) during follow-up;\r\n\r\n               -  For Work Package 4: patients with a stable disease enrolled in OFSEP-HD study in\r\n                  Nmes or Nantes University Hospitals.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Within the past three months, the patient has participated in another interventional\r\n             study that may interfere with the results or conclusions of this study.\r\n\r\n          -  The patient is in an exclusion period determined by a previous study.\r\n\r\n          -  The patient is under judicial protection.\r\n\r\n          -  The patient refuses to sign the consent.\r\n\r\n          -  It is impossible to correctly inform the patient (inability to understand the study,\r\n             language problem).\r\n\r\n          -  The patient is pregnant or breast-feeding.\r\n\r\n          -  The patient is under 15 years old.\r\n\r\n          -  Inability to answer questionnaires.\r\n\r\n          -  Clinically isolated syndrome (CIS) that does not meet the criteria of MS.\r\n\r\n          -  Radiologically isolated syndrome (RIS).\r\n\r\n          -  Patient with Neuromyelitis optica spectrum disorder.\r\n      ","sponsor":"Centre Hospitalier Universitaire de Nmes","sponsor_type":"Other","conditions":"Multiple Sclerosis","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Blood sample","description":"2 x 4 ml tubes blood to screen for serum Neurofilament Light Chain and GFAP levels"}],"outcomes":[{"outcome_type":"primary","measure":"Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease","time_frame":"Inclusion","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"primary","measure":"GFAP level in patients with evolving disease compared to those with stable disease","time_frame":"Inclusion","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"primary","measure":"Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease","time_frame":"6 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"primary","measure":"GFAP level in patients with evolving disease compared to those with stable disease","time_frame":"6 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"primary","measure":"Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease","time_frame":"12 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"primary","measure":"GFAP level in patients with evolving disease compared to those with stable disease","time_frame":"12 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"primary","measure":"Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease","time_frame":"18 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"primary","measure":"GFAP level in patients with evolving disease compared to those with stable disease","time_frame":"18 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"primary","measure":"Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease","time_frame":"2 years","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"primary","measure":"GFAP level in patients with evolving disease compared to those with stable disease","time_frame":"2 years","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.","time_frame":"Inclusion","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"GFAP level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.","time_frame":"Inclusion","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.","time_frame":"6 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"GFAP level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.","time_frame":"6 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.","time_frame":"1 year","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"GFAP level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.","time_frame":"1 year","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.","time_frame":"18 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"GFAP level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.","time_frame":"18 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.","time_frame":"2 years","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"GFAP level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.","time_frame":"2 years","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with progressive disease measured by Expanded Disability Status Scale (1 point until 5.5 and 0.5 point after 5.5) compared to stable patients","time_frame":"Inclusion","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"GFAP level in patients with progressive disease measured by Expanded Disability Status Scale (1 point until 5.5 and 0.5 point after 5.5) compared to stable patients","time_frame":"Inclusion","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with progressive disease measured by Expanded Disability Status Scale (1 point until 5.5 and 0.5 point after 5.5) compared to stable patients","time_frame":"6 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"GFAP level in patients with progressive disease measured by Expanded Disability Status Scale (1 point until 5.5 and 0.5 point after 5.5) compared to stable patients","time_frame":"6 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with progressive disease measured by Expanded Disability Status Scale (1 point until 5.5 and 0.5 point after 5.5) compared to stable patients","time_frame":"1 year","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"GFAP level in patients with progressive disease measured by Expanded Disability Status Scale (1 point until 5.5 and 0.5 point after 5.5) compared to stable patients","time_frame":"1 year","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with progressive disease measured by Expanded Disability Status Scale (1 point until 5.5 and 0.5 point after 5.5) compared to stable patients","time_frame":"18 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"GFAP level in patients with progressive disease measured by Expanded Disability Status Scale (1 point until 5.5 and 0.5 point after 5.5) compared to stable patients","time_frame":"18 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with progressive disease measured by Expanded Disability Status Scale (1 point until 5.5 and 0.5 point after 5.5) compared to stable patients","time_frame":"2 years","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"GFAP level in patients with relapse compared to stable patients","time_frame":"Inclusion","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with relapse compared to stable patients","time_frame":"6 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"GFAP level in patients with relapse compared to stable patients","time_frame":"6 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with relapse compared to stable patients","time_frame":"1 year","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"GFAP level in patients with relapse compared to stable patients","time_frame":"1 year","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with relapse compared to stable patients","time_frame":"18 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"GFAP level in patients with relapse compared to stable patients","time_frame":"18 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with relapse compared to stable patients","time_frame":"2 years","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"GFAP level in patients with relapse compared to stable patients","time_frame":"2 years","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with isolated MRI activity compared to stable patients","time_frame":"Inclusion","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"GFAP level in patients with isolated MRI activity compared to stable patients","time_frame":"Inclusion","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with isolated MRI activity compared to stable patients","time_frame":"6 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"GFAP level in patients with isolated MRI activity compared to stable patients","time_frame":"6 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with isolated MRI activity compared to stable patients","time_frame":"1 year","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with isolated MRI activity compared to stable patients","time_frame":"1 year","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with isolated MRI activity compared to stable patients","time_frame":"18 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with isolated MRI activity compared to stable patients","time_frame":"18 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with isolated MRI activity compared to stable patients","time_frame":"2 years","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with isolated MRI activity compared to stable patients","time_frame":"2 years","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients","time_frame":"Inclusion","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients","time_frame":"Inclusion","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients","time_frame":"6 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients","time_frame":"6 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients","time_frame":"1 year","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients","time_frame":"1 year","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients","time_frame":"18 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients","time_frame":"18 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients","time_frame":"2 year","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients","time_frame":"2 year","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients","time_frame":"Inclusion","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients","time_frame":"Inclusion","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients","time_frame":"6 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients","time_frame":"6 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients","time_frame":"1 year","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients","time_frame":"1 year","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients","time_frame":"18 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients","time_frame":"18 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients","time_frame":"2 years","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients","time_frame":"2 years","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort","time_frame":"Inclusion","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort","time_frame":"Inclusion","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort","time_frame":"6 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort","time_frame":"6 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort","time_frame":"1 year","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort","time_frame":"1 year","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort","time_frame":"18 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort","time_frame":"18 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort","time_frame":"2 years","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort","time_frame":"2 years","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease","time_frame":"Inclusion","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease","time_frame":"Inclusion","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease","time_frame":"6 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease","time_frame":"6 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease","time_frame":"1 year","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease","time_frame":"1 year","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease","time_frame":"18 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease","time_frame":"18 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease","time_frame":"2 years","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease","time_frame":"2 years","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with disease evolution (relapse, disability progression or MRI activity)","time_frame":"Inclusion","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with disease evolution (relapse, disability progression or MRI activity)","time_frame":"Inclusion","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with disease evolution (relapse, disability progression or MRI activity)","time_frame":"6 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with disease evolution (relapse, disability progression or MRI activity)","time_frame":"6 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with disease evolution (relapse, disability progression or MRI activity)","time_frame":"1 year","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with disease evolution (relapse, disability progression or MRI activity)","time_frame":"1 year","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with disease evolution (relapse, disability progression or MRI activity)","time_frame":"18 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with disease evolution (relapse, disability progression or MRI activity)","time_frame":"18 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with disease evolution (relapse, disability progression or MRI activity)","time_frame":"2 years","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with disease evolution (relapse, disability progression or MRI activity)","time_frame":"2 years","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity)","time_frame":"Inclusion","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with disease activity (relapse or MRI activity)","time_frame":"Inclusion","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with disease activity (relapse, or MRI activity)","time_frame":"6 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with disease activity (relapse, or MRI activity)","time_frame":"6 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity)","time_frame":"1 year","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with disease activity (relapse or MRI activity)","time_frame":"1 year","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity)","time_frame":"18 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with disease activity (relapse or MRI activity)","time_frame":"18 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity)","time_frame":"2 years","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with disease activity (relapse or MRI activity)","time_frame":"2 years","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with relapses","time_frame":"Inclusion","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with relapses","time_frame":"Inclusion","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with relapses","time_frame":"6 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with relapses","time_frame":"6 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with relapses","time_frame":"1 year","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with relapses","time_frame":"1 year","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with relapses","time_frame":"18 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with relapses","time_frame":"18 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with relapses","time_frame":"2 years","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with relapses","time_frame":"2 years","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with MRI activity","time_frame":"Inclusion","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with MRI activity","time_frame":"Inclusion","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with MRI activity","time_frame":"6 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with MRI activity","time_frame":"6 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with MRI activity","time_frame":"1 year","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with MRI activity","time_frame":"1 year","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with MRI activity","time_frame":"18 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with MRI activity","time_frame":"18 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with MRI activity","time_frame":"2 years","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with MRI activity","time_frame":"2 years","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement","time_frame":"Inclusion","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement","time_frame":"Inclusion","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement","time_frame":"6 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement","time_frame":"6 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement","time_frame":"1 year","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement","time_frame":"1 year","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement","time_frame":"18 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement","time_frame":"18 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement","time_frame":"2 years","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement","time_frame":"2 years","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement","time_frame":"Inclusion","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement","time_frame":"Inclusion","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement","time_frame":"6 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement","time_frame":"6 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement","time_frame":"1 year","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement","time_frame":"1 year","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement","time_frame":"18 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement","time_frame":"18 months","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement","time_frame":"2 years","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement","time_frame":"2 years","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Level of disability","time_frame":"Inclusion","description":"Expanded Disability Status Scale (EDSS); scale 1= no disability to 10 = death from multiple sclerosis"},{"outcome_type":"secondary","measure":"Level of disability","time_frame":"Relapse (measured up to 2 years)","description":"Expanded Disability Status Scale (EDSS); scale 1= no disability to 10 = death from multiple sclerosis"},{"outcome_type":"secondary","measure":"Severity of multiple sclerosis","time_frame":"EDSS progression (measured up to 2 years)","description":"Multiple Sclerosis Functional Composite"},{"outcome_type":"secondary","measure":"Severity of multiple sclerosis","time_frame":"Active MRI (measured up to 2 years)","description":"Multiple Sclerosis Functional Composite"},{"outcome_type":"secondary","measure":"Generic health status","time_frame":"Inclusion","description":"EuroQol 5 dimension questionnaire (EQ-5D)"},{"outcome_type":"secondary","measure":"Generic health status","time_frame":"Relapse (measured up to 2 years)","description":"EuroQol 5 dimension questionnaire (EQ-5D)"},{"outcome_type":"secondary","measure":"Generic health status","time_frame":"EDSS progression (measured up to 2 years)","description":"EuroQol 5 dimension questionnaire (EQ-5D)"},{"outcome_type":"secondary","measure":"Generic health status","time_frame":"active MRI (measured up to 2 years)","description":"EuroQol 5 dimension questionnaire (EQ-5D)"},{"outcome_type":"secondary","measure":"Use of Disease Modifying Drugs","time_frame":"Inclusion","description":"Categorized by class type of treatment (1st line, 2nd line and 3rd line therapies)"},{"outcome_type":"secondary","measure":"Use of Disease Modifying Drugs","time_frame":"6 monrths","description":"Categorized by class type of treatment (1st line, 2nd line and 3rd line therapies)"},{"outcome_type":"secondary","measure":"Use of Disease Modifying Drugs","time_frame":"1 year","description":"Categorized by class type of treatment (1st line, 2nd line and 3rd line therapies)"},{"outcome_type":"secondary","measure":"Use of Disease Modifying Drugs","time_frame":"18 months","description":"Categorized by class type of treatment (1st line, 2nd line and 3rd line therapies)"},{"outcome_type":"secondary","measure":"Use of Disease Modifying Drugs","time_frame":"2 years","description":"Categorized by class type of treatment (1st line, 2nd line and 3rd line therapies)"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain in 800 patients from the OFSEP cohort including Multiple Sclerosis patients at different stages and Neuromyelitis optica spectrum disorder patients","time_frame":"Inclusion","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP in 800 patients from the OFSEP cohort including Multiple Sclerosis patients at different stages and Neuromyelitis optica spectrum disorder patients","time_frame":"Inclusion","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain in 800 patients from the OFSEP cohort including Multiple Sclerosis patients at different stages and Neuromyelitis optica spectrum disorder patients","time_frame":"Month 6","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP in 800 patients from the OFSEP cohort including Multiple Sclerosis patients at different stages and Neuromyelitis optica spectrum disorder patients","time_frame":"Month 6","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain in 400 patients from the OFSEP cohort with a Clinically Isolated Syndrome at inclusion","time_frame":"Inclusion","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP in 400 patients from the OFSEP cohort with a Clinically Isolated Syndrome at inclusion","time_frame":"Inclusion","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum Neurofilament Light Chain in 400 patients from the OFSEP cohort with a Clinically Isolated Syndrome at inclusion","time_frame":"Month 6","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Serum GFAP in 400 patients from the OFSEP cohort with a Clinically Isolated Syndrome at inclusion","time_frame":"Month 6","description":"pg/mL; measured by digital ELISA"},{"outcome_type":"secondary","measure":"Create biobank","time_frame":"Inclusion","description":"Blood samples"},{"outcome_type":"secondary","measure":"Create biobank","time_frame":"6 months","description":"Blood samples"},{"outcome_type":"secondary","measure":"Create biobank","time_frame":"1 year","description":"Blood samples"},{"outcome_type":"secondary","measure":"Create biobank","time_frame":"18 months","description":"Blood samples"},{"outcome_type":"secondary","measure":"Create biobank","time_frame":"2 years","description":"Blood samples"}]}
{"nct_id":"NCT03862742","start_date":"2019-05-22","enrollment":100,"brief_title":"Role of Wrist Based Blood Pressure Monitoring in Clinical Practice","official_title":"Role of Wrist Based Blood Pressure Monitoring in Clinical Practice","primary_completion_date":"2020-03-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2020-03-31","last_update":"2019-06-12","description":"This is a pilot clinical study to test the overarching hypothesis that frequent and longitudinal blood pressure monitoring with FDA approved consumer wrist based device during the patient transition from inpatient to home to the first clinic visit will elicit valuable BP data that can assist in physician treatment of hypertension","other_id":"IRB-18-7223","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Individuals 18 years of age or older with and without the known diagnosis of hypertension\r\n        (regardless of level of control or therapeutic regimen), able to operate HeartVue device,\r\n        able to read, write, and speak English, level of \"digital savviness\" and owning an iOS or\r\n        Android device will be recruited for participation in this pilot study.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18 years of age\r\n\r\n          -  Own an iOS or Android device\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Inability to give informed consent\r\n\r\n          -  <18 years of age\r\n\r\n          -  Inability to understand written English language\r\n\r\n          -  Hypertensive urgency or emergency as an admission diagnosis\r\n      ","sponsor":"Scripps Translational Science Institute","sponsor_type":"Other","conditions":"Blood Pressure|Transitions of Care","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Blood pressure","time_frame":"Pts will monitor BP during the transition from inpatient to home to the first clinic visit. BP measurements will be performed several times during the day and several times at night. The estimated time frame when data will be collected is 24 to 48 hours","description":"blood pressure measured by the wrist watch like blood pressure device"},{"outcome_type":"secondary","measure":"Survey of healthcare providers","time_frame":"A survey to measure how easy it is to use the device will be obtained at the completion of data collection. The estimated timeframe when the survey will be completed is 24 to 48 hours.","description":"Survey to measure ease of use to the device in measuring blood pressure"},{"outcome_type":"secondary","measure":"Survey of patients","time_frame":"A survey to measure how easy it is to use the device will be obtained at the completion of data collection. The estimated timeframe when the survey will be completed is 24 to 48 hours.","description":"Survey to measure ease of use to the device in measuring blood pressure"}]}
{"nct_id":"NCT03916978","start_date":"2019-05-21","phase":"Phase 2/Phase 3","enrollment":100,"brief_title":"Autologous PRP Intra Ovarian Infusion to Restore Ovarian Function in Menopausal Women","official_title":"Investigating Reactivation of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in Menopausal Women","primary_completion_date":"2023-01-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-01-30","last_update":"2020-07-29","description":"Autologous PRP intra ovarian infusion may restore ovarian function, may promote folliculogenesis and may improve hormonal profile of women in menopause.","other_id":"PRP - Menopausal women","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"Female","minimum_age":45,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age between 45-55 years old\r\n\r\n          -  Amenorrhea for at least 12 months\r\n\r\n          -  Discontinuation of any complementary/adjuvant treatment including hormone replacement,\r\n             acupuncture, and botanotherapy, for at least three months prior to recruitment.\r\n\r\n          -  Willing to comply with study requirements\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any pathological disorder related to reproductive system anatomy\r\n\r\n          -  Previous POI diagnosis\r\n\r\n          -  Abnormal karyotype\r\n\r\n          -  Endometriosis\r\n\r\n          -  Adenomyosis\r\n\r\n          -  Fibroids and adhesions\r\n\r\n          -  Infections in reproductive system\r\n\r\n          -  Current or previous diagnosis of reproductive system cancer\r\n\r\n          -  History of familiar cancer in reproductive system\r\n\r\n          -  Severe male factor infertility\r\n\r\n          -  Prior referral for PGT\r\n\r\n          -  Ovarian inaccessibility\r\n\r\n          -  Endocrinological disorders (Hypothalamus-Pituitary disorders, thyroid dysfunction,\r\n             diabetes mellitus, metabolic syndrome)\r\n\r\n          -  BMI>30 kg/m2 or BMI<18.5 kg/m2\r\n\r\n          -  Systematic autoimmune disorders\r\n      ","sponsor":"Genesis Athens Clinic","sponsor_type":"Other","conditions":"Infertility, Female|Anovulatory Infertility|Menopause|Amenorrhea","interventions":[{"intervention_type":"Biological","name":"Biological: Autologous PRP intra ovarian infusion","description":"Autologous PRP intra ovarian infusion"},{"intervention_type":"Biological","name":"Biological: Autologous PFP intra ovarian infusion","description":"Autologous PFP intra ovarian infusion"}],"outcomes":[{"outcome_type":"primary","measure":"Restoration of menstrual cycle","time_frame":"Three months","description":"Menstrual cycle restoration"},{"outcome_type":"primary","measure":"Serum FSH levels","time_frame":"Follow-up period of three months entailing monthly evaluation","description":"Serum FSH levels evaluated monthly for three consecutive months."},{"outcome_type":"secondary","measure":"Serum AMH levels","time_frame":"Follow-up period of three months entailing monthly evaluation","description":"Serum AMH levels evaluated monthly for three consecutive months."},{"outcome_type":"secondary","measure":"Serum estradiol levels","time_frame":"Follow-up period of three months entailing monthly evaluation","description":"Serum estradiol levels evaluated monthly for three consecutive months."},{"outcome_type":"secondary","measure":"Serum LH levels","time_frame":"Follow-up period of three months entailing monthly evaluation","description":"Serum LH levels evaluated monthly for three consecutive months."},{"outcome_type":"secondary","measure":"Serum progesterone levels","time_frame":"Follow-up period of three months entailing monthly evaluation","description":"Serum progesterone levels evaluated monthly for three consecutive months."},{"outcome_type":"secondary","measure":"Antral Follicle Count","time_frame":"Follow-up period of three months entailing monthly evaluation","description":"AFC evaluated monthly, on day 2 of the menstrual cycle, for three consecutive months."}]}
{"nct_id":"NCT03880110","start_date":"2019-05-20","enrollment":1000,"brief_title":"Early Prediction of Acute Kidney Injury in High Risk Patients After Non-cardiac Surgery","official_title":"Combination of Biomarkers, Urine Sedimentation and Renal Resistive Index for Early Prediction of Acute Kidney Injury in High Risk Patients After Non-cardiac Surgery: a Prospective Observational Cohort Study","primary_completion_date":"2021-10-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2021-11-30","last_update":"2021-06-30","description":"Acute kidney injury (AKI) is a common complication after non-cardiac surgery with adverse short and long term morbidity and mortality. So far there have been no effective therapy for AKI treatment developed, possibly due to the heterogenicity of this syndrome. Therefore, prevention of AKI in high risk patients undergoing non-cardiac surgery, as emphasized by Kidney Disease Improving Global Outcomes (KDIGO), becomes the first priority. However, early prediction of AKI is the first step before taking preventive measures, which really make a great challenge to clinical practitioners because of such a limited time window and complex clinical scenarios. Recently, cumulative evidence have shown that biomarkers and renal ultrasound may play an important role in AKI prediction after non-cardiac surgery. The purpose of this study is to investigate the combination of biomarkers, urine sedimentation and renal resistive index for early prediction of AKI in high risk patients undergoing non-cardiac surgery.","other_id":"Early predicting AKI","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"High risk patients undergoing non-cardiac surgery","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age  18 years; Undergoing non-cardiac surgery; Admitted to SICU immediately after\r\n             surgery\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Chronic kidney disease stage 5 (CKD-5) or requiring long-term dialysis; Undergoing\r\n             kidney-related surgery; AKI before admission to SICU; Without Foley catheter placement\r\n             ;Written informed consent not obtained\r\n      ","sponsor":"Peking University First Hospital","sponsor_type":"Other","conditions":"Acute Kidney Injury","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Incidence of acute kidney injury within 7 days after surgery","time_frame":"within 7 days after surgery","description":"AKI is diagnosed according to KDIGO criteria"},{"outcome_type":"secondary","measure":"Severity of acute kidney injury within 7 days after surgery","time_frame":"within 7 days after surgery","description":"AKI is classified according to KDIGO criteria"},{"outcome_type":"secondary","measure":"Incidence of postoperative complications","time_frame":"30 days after operation or withdrawing the study ( the first thing that happens: discharge/death)","description":"Defined as newly onset medical conditions that are harmful to patients' recovery and required therapeutic intervention, including pulmonary infection, pleural effusion, atelectasis, respiratory failure, surgical bleeding, new onset arrhythmia, acute myocardial infarction, congestive heart failure, stroke, ileus, liver injury, digestive tract bleeding, wound infection, urinary tract infection, severe sepsis, acute kidney injury, pulmonary embolism and deep venous thrombosis."},{"outcome_type":"secondary","measure":"Rate of ICU or in-hospital mortality","time_frame":"30 days after operation or withdrawing the study ( the first thing that happens: discharge/death)","description":"ICU/In-hospital mortality"},{"outcome_type":"secondary","measure":"Rate of dialysis dependent at discharge","time_frame":"Until the first thing that happens: discharge/death, 30 days after operation or withdrawing the study.","description":"Defined as requiring any modality of renal replacement therapy at discharge"},{"outcome_type":"secondary","measure":"Rate of continuous decreased kidney function at discharge","time_frame":"30 days after operation or withdrawing the study ( the first thing that happens: discharge/death)","description":"Estimated glomerular filtration rate (eGFR) decreased more than 25% of baseline value at discharge"},{"outcome_type":"secondary","measure":"Rate of major adverse kidney events (MAKE)","time_frame":"30 days after operation or withdrawing the study ( the first thing that happens: discharge/death)","description":"Defined as a composite of death, dialysis dependent or continuous decreased kidney function"}]}
{"nct_id":"NCT03840291","start_date":"2019-05-19","phase":"Phase 4","enrollment":60,"brief_title":"Resolution of Thrombi in Left Atrial Appendage With Edoxaban","official_title":"Resolution of Thrombi in Left Atrial Appendage With Edoxaban","primary_completion_date":"2022-08-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-08-31","last_update":"2020-06-22","description":"Non-valvular (NV) atrial fibrillation (AF) increases the risk of stroke by approximately fivefold. The atrial thrombi associated with AF are seen within the left atrial appendage (LAA) in most cases (> 90%). Anticoagulation with a vitamin-K antagonist (VKA) is recommended to prevent thromboembolic complications and to resolve thrombi. Non-VKA oral anticoagulants (NOACs) have replaced the VKA for the thromboprophylaxis in patients with NVAF since 2010. Therefore, NOAC can be the excellent alternative to VKA concerning resolving preexisting LAA thrombi because of its rapid onset of action and no need of bridging with heparin. However, there is still lack of data regarding the optimal treatment for patients with AF and thrombi in LAA with NOAC. There are only several case reports of the efficacy of NOACs in resolving LAA thrombi available. Edoxaban, which has data showing efficacy and safety in thromboprophylaxis, can be the new option for treatment of patients with AF and LAA thrombi. The purpose of this study is to evaluate the efficacy of Edoxaban in resolving the LAA thrombi, which is related with nonvalvular AF.","other_id":"2018-09-041","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Men or women aged  20 years\r\n\r\n          -  Hemodynamically stable nonvalvular AF or atrial flutter\r\n\r\n          -  LAA thrombus documented by TEE up to 72 hours prior to start of study medication\r\n\r\n          -  VKA or NOAC-nave or untreated within 1 month prior to sign the informed consent\r\n\r\n          -  VKA pretreated but under the therapeutic International Normalized ratio levels (<2.0;\r\n             documented with at least 2 consecutive measurements that are at least 24 hours apart)\r\n             within last 6 weeks\r\n\r\n          -  Women of childbearing potential and men must agree to use adequate contraception when\r\n             sexually active\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Transient Ischemic Attack within 3 days prior to study inclusion\r\n\r\n          -  Severe, disabling stroke (modified Rankin score of 4-5, inclusive) within 3 months or\r\n             any stroke within 14 days before the start of study drug\r\n\r\n          -  Acute thromboembolic events or thrombosis (venous/arterial) within the last 14 days\r\n             prior to study inclusion\r\n\r\n          -  Acute myocardial infarction within the last 14 days prior to study inclusion\r\n\r\n          -  Cardiac-related criteria: Previous intracardiac thrombus, Free-floating ball thrombus,\r\n             Intracardiac tumor, known left ventricular or aortic thrombus\r\n\r\n          -  Active bleeding or high risk for bleeding contraindicating anticoagulant therapy\r\n      ","sponsor":"Keimyung University Dongsan Medical Center","sponsor_type":"Other","conditions":"Atrial Fibrillation|Left Atrial Appendage Thrombosis","interventions":[{"intervention_type":"Drug","name":"Drug: Edoxaban","description":"Edoxaban will be used for resolution of left atrial appendage thrombi"}],"outcomes":[{"outcome_type":"primary","measure":"complete resolution of LAA thrombi","time_frame":"6 weeks","description":"The percentage of subjects with complete resolution of LAA thrombi"},{"outcome_type":"secondary","measure":"Treatment responses of thrombi","time_frame":"6 weeks","description":"Treatment responses of thrombi: Number of participants with resolved, reduced, unchanged, enlarged thrombi or newly appeared thrombi"},{"outcome_type":"secondary","measure":"Ischemic stroke event","time_frame":"12 weeks","description":"The percentage of subjects who experienced ischemic stroke"},{"outcome_type":"secondary","measure":"Bleeding event","time_frame":"12 weeks","description":"The percentage of subjects who experienced bleeding event"}]}
{"nct_id":"NCT03954353","start_date":"2019-05-17","enrollment":78888,"brief_title":"Effect of Cholesterol Level on Postoperative Acute Kidney Injury of Non-cardiac Surgeries","official_title":"Effect of Cholesterol Level on Postoperative Acute Kidney Injury of Non-cardiac Surgeries","primary_completion_date":"2019-06-05","study_type":"Observational","rec_status":"Completed","completion_date":"2019-06-06","last_update":"2019-07-09","description":"Preoperative serum cholesterol level may influence occurrence of postoperative acute kidney injury of cardiac surgeries. However, the effect of Preoperative serum cholesterol level for non cardiac surgery remains unknown. This study aimed to explore the effect in non-cardiac surgical population.","other_id":"ECAKI","observational_model":"Other","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"adults (age  18 years old) who underwent elective non-cardiac surgery from January 1,\r\n        2012, to December 31, 2017.","criteria":"\n        Inclusion Criteria:\r\n\r\n        adults elective non-cardiac surgery\r\n\r\n        Exclusion Criteria:\r\n\r\n        cardiac surgeries kidney surgeries obstetric surgeries local infiltration anesthesia\r\n        perioperative data missing\r\n      ","sponsor":"Peking University First Hospital","sponsor_type":"Other","conditions":"Acute Kidney Injury","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"post-operative acute kidney injury within 30 days in the hospital","time_frame":"30 days postoperatively in hospital","description":"It was defined by patient's postoperative serum creatine increase no less than 26.5 μmol/l within 48 hours, or 1.5 times from baseline within the 7 days after surgery or initializing blood dialysis."}]}
{"nct_id":"NCT04487054","start_date":"2019-05-16","phase":"N/A","enrollment":104,"brief_title":"Outcomes of Early Palliative Care Intervention for High-Risk Patients in the Intensive Care Unit-A Pilot Study","official_title":"Outcomes of Early Palliative Care Intervention for High-Risk Patients in the Intensive Care Unit- A Pilot Study","primary_completion_date":"2021-01-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2021-01-31","last_update":"2020-07-27","description":"The investigators propose to conduct a feasibility study of identifying high-risk ICU patients using previously validated integrated prediction model and employing early palliative care intervention. The study will consist of two four-month time periods: usual care in time period one and usual care plus targeted pro-active palliative care intervention within 48 hours of ICU admission in time period two.","other_id":"1711863473","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","intervention_model_description":"Pre and post phase study evaluating the utility of pro-active palliative care in high risk ICU patients identified using integrated prediction model","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients greater than 18 years of age admitted to the medical ICU at West Virginia\r\n             University Hospital.\r\n\r\n          -  Patients with a predicted six-month mortality greater than 40% on the integrated\r\n             prognostic model.\r\n\r\n          -  Patients who live longer than 48 hours after medical ICU admission.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patient who did not meet inclusion criteria will be excluded.\r\n\r\n          -  Pregnant female/incarcerated patients will be excluded.\r\n\r\n          -  Since this is a study in an adult patient population, children will be excluded.\r\n      ","sponsor":"West Virginia University","sponsor_type":"Other","conditions":"End-of-life Care|Palliative Care|Intensive Care Unit","interventions":[{"intervention_type":"Other","name":"Other: Pro-active palliative care","description":"Patient with high risk of mortality in ICU will be identified using our previously validated prognostic model. Intervention phase will employ pro-active palliative care on eligible patients after they survive 48 hours in ICU."}],"outcomes":[{"outcome_type":"primary","measure":"Length Of Stay (LOS) in the medical ICU","time_frame":"From enrollment to Discharge from the ICU, an average of 24 weeks"},{"outcome_type":"primary","measure":"Length Of Stay in hospital","time_frame":"From enrollment to Discharge from the hospital, an average of 24 weeks"},{"outcome_type":"primary","measure":"Medical ICU re-admission during the hospital stay","time_frame":"From enrollment to discharge from the hospital, up to 16 weeks"},{"outcome_type":"primary","measure":"Treatment limitation orders (do-not-resuscitate, do-not-intubate, no vasopressors, etc) within 48 hours of admission","time_frame":"From enrollment to discharge from the hospital, an average of 24 weeks"},{"outcome_type":"primary","measure":"Family satisfaction with care in ICU (modified from the FS-ICU 24 and Bereaved Family Survey (BFS) global performance measure #18)","time_frame":"From enrollment to six weeks post ICU discharge","description":"Six-weeks post discharge, a telephone survey will be conducted with health care surrogate or medical power attorney to determine their satisfaction with the care received in ICU. The results will be compared between participants that received early palliative care intervention and those that did not."},{"outcome_type":"primary","measure":"Advance directive completion [a written statement of a person's wishes regarding medical treatment]","time_frame":"From enrollment to hospital discharge, an average of 24 weeks","description":"Difference in completion rate of the advance directive between the baseline period and following the intervention"},{"outcome_type":"primary","measure":"Physician Orders for Scope of Treatment (POST) form completion","time_frame":"From enrollment to hospital discharge, an average of 24 weeks","description":"Difference in completion rate of the Physician Orders for scope of Treatment (POST) form between the baseline period and following the intervention"},{"outcome_type":"primary","measure":"Discharge outcomes","time_frame":"From enrollment to six weeks post ICU discharge","description":"Difference in discharge outcome (location) between the baseline period and following the intervention"},{"outcome_type":"primary","measure":"Site of death (ICU, hospital, home, hospice nursing home)","time_frame":"From enrollment to six weeks post ICU discharge"}]}
{"nct_id":"NCT03133143","start_date":"2019-05-16","phase":"N/A","enrollment":143,"brief_title":"Video Games Among People With Schizophrenia","official_title":"The Impact of Video Gaming on Cognitive Functioning in People With Schizophrenia","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2022-12-31","last_update":"2021-06-08","description":"The investigators aim to establish a research project to test the impact of gaming by carrying out a digital gaming interventions, monitoring its cognitive and clinical outcomes, while concurrently performing a multimodal brain imaging experiment.","other_id":"HSEARS20161228002","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"Double","intervention_model_description":"A controlled, single-blind clinical trial with a pragmatic, three-arm parallel-group design.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion criteria:\r\n\r\n          -  patients' diagnoses of schizophrenia (Diagnostic and Statistical Manual DSM-IV)\r\n\r\n          -  able to speak Cantonese\r\n\r\n          -  be unfamiliar with video games or at least non-active game players (play < 5h/week)\r\n\r\n          -  have the ability to provide written informed consent\r\n\r\n          -  be viewed as being able to safely take part and have the cognitive status deemed\r\n             suitable for participation (assessed by a chief psychiatrist based on his/her clinical\r\n             expertise)\r\n\r\n        Exclusion criteria:\r\n\r\n          -  meeting diagnostic criteria for a current major depressive, manic or hypomanic episode\r\n             (DSM-IV), or mental retardation\r\n\r\n          -  having severe visual impairment\r\n\r\n          -  being an active game player (i.e. gaming > 5 h/week)\r\n\r\n          -  displaying a lack of ability to decide their own participation\r\n\r\n          -  displaying substance abuse (other than nicotine dependence)\r\n\r\n          -  having head injury, hemiplegia, or other neurological disorders\r\n\r\n          -  having had an Electroconvulsive Therapy (ECT) in the past six months\r\n\r\n          -  having a lack of Magnetic Resonance Imaging (MRI) compatibility (for example, patients\r\n             with cardiac pacemakers, metallic implants, restless behaviour)\r\n\r\n          -  pregnancy\r\n      ","sponsor":"The Hong Kong Polytechnic University","sponsor_type":"Other","conditions":"Cognitive Function|Schizophrenia and Disorders With Psychotic Features","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Cognifit","description":"CogniFit is an Internet browser-based digital brain training program, to improve cognitive abilities based on a personalised brain training regimen. Participants are instructed to play all games assigned by cognifit from three categories (memory, spatial perception, and mental planning) during each training session. After playing the games in these three categories, they are free to choose which exercises they wish to play."},{"intervention_type":"Behavioral","name":"Behavioral: SIMS 4 (Maxis, Inc)","description":"The Sims 4 is a life simulation PC game. It is purely an entertainment game without known cognitive or health-related outcomes. Does not iclude high-intensity action and competition. This specific game and non-competitive games like it in general do not improve attention, working memory, or other cognitive abilities despite being engaging and fun."}],"outcomes":[{"outcome_type":"secondary","measure":"Social functioning: treatment response in social phobia","time_frame":"Baseline, after intervention (three months) and at six months follow-up","description":"A Chinese version of Brief Social Phobia Scale (BSPS51) assessing treatment response in social phobia."},{"outcome_type":"primary","measure":"Verbal working memory function at 3-month and 6-month follow-ups","time_frame":"3-month and 6-month follow-ups","description":"Measured by Letter-number-span task from Wechsler Memory Scale III (WMS III), simplified/traditional Chinese versions. The instrument includes the National Institute of Mental Health - Measurement and Treatment Research to Improve Cognition in Schizophrenia 50 battery (NIMH-MATRICS50)."},{"outcome_type":"secondary","measure":"Cognitive functioning: speed of processing","time_frame":"Baseline, after intervention (three months) and at six months follow-up","description":"A battery of cognitive tests: speed of processing [Trail Making Test A]."},{"outcome_type":"secondary","measure":"Cognitive functioning: attention","time_frame":"Baseline, after intervention (three months) and at six months follow-up","description":"A battery of cognitive tests: attention (serotonin transporter; SERT)."},{"outcome_type":"secondary","measure":"Cognitive functioning: vigilance","time_frame":"Baseline, after intervention (three months) and at six months follow-up","description":"A battery of cognitive tests: vigilance [SERT]."},{"outcome_type":"secondary","measure":"Cognitive functioning: visuo-spatial working memory","time_frame":"Baseline, after intervention (three months) and at six months follow-up","description":"A battery of cognitive tests: visuo-spatial working memory [Spatial span from WMS III]."},{"outcome_type":"secondary","measure":"Cognitive functioning: reasoning","time_frame":"Baseline, after intervention (three months) and at six months follow-up","description":"A battery of cognitive tests: reasoning [Wisconsin Card Sorting Task)."},{"outcome_type":"secondary","measure":"Cognitive functioning: problem solving","time_frame":"Baseline, after intervention (three months) and at six months follow-up","description":"A battery of cognitive tests: problem solving [Wisconsin Card Sorting Task)."},{"outcome_type":"secondary","measure":"Social functioning: severity of social phobia","time_frame":"Baseline, after intervention (three months) and at six months follow-up","description":"A Chinese version of Brief Social Phobia Scale (BSPS51) assessing severity of social phobia."},{"outcome_type":"secondary","measure":"Experience of pleasure: anticipatory component","time_frame":"Baseline, after intervention (three months) and at six months follow-up","description":"The 'temporal Experience of Pleasure Scale' (TEPS, Chinese version) covers the anticipatory component."},{"outcome_type":"secondary","measure":"Experience of pleasure: consummatory component","time_frame":"Baseline, after intervention (three months) and at six months follow-up","description":"The 'temporal Experience of Pleasure Scale' (TEPS, Chinese version) covers the consummatory component."},{"outcome_type":"secondary","measure":"Self-efficacy","time_frame":"Baseline, after intervention (three months) and at six months follow-up","description":"Chinese version of 'General Self-Efficacy Scale' (GSE) is a self-report measure of self-efficacy."},{"outcome_type":"secondary","measure":"Psychotic symptoms","time_frame":"Baseline, after intervention (three months) and at six months follow-up","description":"The Chinese version of the Clinical Assessment Interview for Negative Symptoms (CAINS) administered by qualified psychiatrists in Hong Kong who have received proper training for this assessment tool."},{"outcome_type":"secondary","measure":"Anhedonia symptoms","time_frame":"Baseline, after intervention (three months) and at six months follow-up","description":"Other symptoms, which might confound negative symptom presentation and need to be assessed include: 'The Calgary Depression Scale for Schizophrenia' (CDS-C), an observer-rated Likert-scale to measure depressive symptoms; The Simpson-Angus Rating Scale (SAS), the Barnes Akathisia Rating Scale (BARS), and the Abnormal Movement Involuntary Scale (AIMS)."},{"outcome_type":"secondary","measure":"Avolition symptoms","time_frame":"Baseline, after intervention (three months) and at six months follow-up","description":"Other symptoms, which might confound negative symptom presentation and need to be assessed include: 'The Calgary Depression Scale for Schizophrenia' (CDS-C), an observer-rated Likert-scale to measure depressive symptoms; The Simpson-Angus Rating Scale (SAS), the Barnes Akathisia Rating Scale (BARS), and the Abnormal Movement Involuntary Scale (AIMS)."},{"outcome_type":"secondary","measure":"Neurocognition: the impact of gaming on brain functional networks (EEG/rsfMRI)","time_frame":"Baseline, after intervention (three months)","description":"EEG/Resting states fMRI. The impact of gaming on brain functional networks can be revealed by recording neuronal activity with M/EEG during the execution of a working memory task and also during resting-state conditions, which reveal changes in spontaneous activities in the brain."},{"outcome_type":"secondary","measure":"Neurocognition: the impact of gaming on changes in neuronal dynamics (EEG/rsfMRI)","time_frame":"Baseline, after intervention (three months)","description":"EEG/Resting states fMRI. The impact of gaming on changes in neuronal dynamics can be revealed by recording neuronal activity with M/EEG during the execution of a working memory task and also during resting-state conditions, which reveal changes in spontaneous activities in the brain."},{"outcome_type":"secondary","measure":"Neurocognition: the impact of gaming on brain functional networks (EEG/Structural magnetic resonance imaging)","time_frame":"Baseline, after intervention (three months)","description":"Structural magnetic resonance imaging. The impact of gaming on brain functional networks can be revealed by recording neuronal activity with M/EEG during the execution of a working memory task and also during resting-state conditions, which reveal changes in spontaneous activities in the brain."},{"outcome_type":"secondary","measure":"Neurocognition: the impact of gaming on changes in neuronal dynamics (EEG/Structural magnetic resonance imaging)","time_frame":"Baseline, after intervention (three months)","description":"Structural magnetic resonance imaging. The impact of gaming on changes in neuronal dynamics can be revealed by recording neuronal activity with M/EEG during the execution of a working memory task and also during resting-state conditions, which reveal changes in spontaneous activities in the brain."}]}
{"nct_id":"NCT03552068","start_date":"2019-05-15","phase":"Phase 2","enrollment":38,"brief_title":"Study of Clonidine Efficacy for the Treatment of Impulse Control Disorders in Parkinson's Disease:","official_title":"Study of Clonidine Efficacy for the Treatment of Impulse Control Disorders in Parkinson's Disease: A Pilot Double Blind Randomized Trial","primary_completion_date":"2021-07-15","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-09-15","last_update":"2021-02-16","description":"Noradrenergic system is involved in impulsivity in the general population and is altered in Parkinson's disease (PD) in the early stages of the disease. Thus, targeting this system could be of interest in impulse control disorder (ICD). Acting on the noradrenergic system is possible using clonidine, an 2 adrenergic agonist largely used in hypertension treatment and that induces a decrease of NADR release. Thus, our aim is to conduct a proof of concept study evaluating the efficacy and safety of clonidine on ICD in PD. This study is a multicenter, randomized, double-blind, placebo-controlled in parallel group clinical trial.","other_id":"69HCL18_0135","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":30,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with PD according to MDS (movement disorders society) criteria for at least\r\n             one year\r\n\r\n          -  Patients with ICD with a QUIP-RS score 10 and/or at least one of the sub-scores in\r\n             the following range: Pathological gambling between >6 and 12; Pathological gambling\r\n             between >8 and 12; Hypersexuality between > 8 and 12; Eating between > 7 and 12. The\r\n             use of \"lower\" margins will guarantee that patients will present behavioral\r\n             disturbances severe enough to justify clonidine treatment. On the other hand, the use\r\n             of \"upper\" margins will guarantee that the patients included in the trial will not\r\n             suffer from ICD too severe to ethically participate to a placebo controlled study.\r\n\r\n          -  Weight between 40 and 95kg\r\n\r\n          -  Stable antiparkinsonian medication since at least 2 months before randomization and\r\n             medication supposed to remain stable during the study\r\n\r\n          -  ICD onset after Parkinson's disease onset and after initiation of dopaminergic drugs\r\n\r\n          -  No signs of dementia (Montreal Cognitive Assessment, MOCA >20);\r\n\r\n          -  No lactose intolerance which may compromise the tolerance of the placebo;\r\n\r\n          -  Patients with health insurance\r\n\r\n          -  Patients without judicial protection measure except directly linked to ICD\r\n\r\n          -  For women of childbearing potential, an effective contraception method for at least 2\r\n             months before randomization (as implants or oral oestro-progestative contraceptives),\r\n             condom use for men during the study. HCG dosage in urine should be negative at\r\n             randomization for women.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Patients with major depression (BDI >19);\r\n\r\n          -  Patients with another parkinsonian syndrome (Parkinson \"plus\" or vascular\r\n             Parkinsonism)\r\n\r\n          -  Orthostatic hypotension\r\n\r\n          -  Patients with swallowing disorders that may prevent oral medication,\r\n\r\n          -  Contraindication to clonidine: Hypersensibility; Severe bradyarythmia due to a cardiac\r\n             disease\r\n\r\n          -  Patients receiving a treatment potentially interacting with clonidine\r\n\r\n          -  Patients with Raynaud's disease or obliterating thromboangiitis\r\n\r\n          -  Patients With Heart failure or severe coronary artery disease\r\n\r\n          -  Patients with a drug treatment having a potential interaction with clonidine (see\r\n             list, appendix 2);\r\n\r\n          -  Presence of renal failure (Cockcroft-Gault at inclusion visit<30 ml/min/1,73m2);\r\n\r\n          -  Patients with a present or past history of addiction (apart ICD) or with a substance\r\n             abuse (except Tabaco)\r\n\r\n          -  Pregnant or lactating women\r\n\r\n          -  Already participating in another biomedical research project\r\n      ","sponsor":"Hospices Civils de Lyon","sponsor_type":"Other","conditions":"Parkinson's Disease|Mpulse Control Disorders","interventions":[{"intervention_type":"Drug","name":"Drug: placebo","description":"Treatment (placebo) will be taken during 8 weeks with one visit at 2, 4 and 8 weeks.\r\nMedication: placebo twice a day (in the morning and evening)."},{"intervention_type":"Drug","name":"Drug: Clonidine","description":"Treatment will be taken during 8 weeks with one visit at 2, 4 and 8 weeks. Medication: 75 g of clonidine twice a day (in the morning and evening)."}],"outcomes":[{"outcome_type":"primary","measure":"QUIP-RS (Questionnaire for Impulsive-Compulsive Disorders in Parkinson's disease - Rating Scale)","time_frame":"at 8 weeks","description":"Diminution of impulse control disorder severity on the initial more elevated sub-score of the QUIP-RS between the first visit and the eighth week under clonidine.\r\nDiminution of impulse control disorder severity on the initial more elevated sub-score of the QUIP-RS between the first visit and the eighth week under clonidine.\r\nDiminution of impulse control disorder severity on the initial more elevated sub-score of the QUIP-RS between the first visit and the eighth week under clonidine."},{"outcome_type":"secondary","measure":"MDS-UPDRS","time_frame":"at 4 and 8 weeks","description":"The Movement Disorder Society Unified Parkinson Disease Rating"},{"outcome_type":"secondary","measure":"STAI","time_frame":"at 4 and 8 weeks","description":"State-Trait Anxiety Index"},{"outcome_type":"secondary","measure":"BDI II","time_frame":"at 4 and 8 weeks","description":"Beck Depression Inventory II It is a self-administered questionnaire each of them using a four-point ordinal scoring system. For the summary index the scores were standardized from 1 to 40, so that higher scores indicate higher depression."},{"outcome_type":"secondary","measure":"ECMP scores","time_frame":"at 4 and 8 weeks","description":"Behavior evaluation of Parkinson's patients It is a self-administered questionnaire each of them using a four-point ordinal scoring system. For the summary index the scores were standardized from 1 to 40, so that higher scores indicate higher depression."},{"outcome_type":"secondary","measure":"QUIP-RS sub-scores","time_frame":"at 4 weeks","description":"Questionnaire for Impulsive-Compulsive Disorders in Parkinson's disease - Rating Scale Diminution of impulse control disorder severity on the initial more elevated sub-score of the QUIP-RS between the first visit and the fourth weeks under clonidine.\r\nIt is a self-administered questionnaire. For the summary index the scores were standardized from 1 to 112, so that higher scores indicate higher Impulse control disorder. The sub score are standardized between 0 and 16."},{"outcome_type":"secondary","measure":"QUIP-RS total score","time_frame":"at 4 and 8 weeks","description":"Evolution of QUIP-RS total score and sub-scores Diminution of impulse control disorder severity on total score of the QUIP-RS between the first visit, the fourth and the eighth weeks under clonidine.\r\nIt is a self-administered questionnaire. For the summary index the scores were standardized from 1 to 112, so that higher scores indicate higher Impulse control disorder."},{"outcome_type":"secondary","measure":"PDQ 39 scale (Parkinson Disease Quotation)","time_frame":"at 4 and 8 weeks","description":"It is a self-administered questionnaire comprised of 39 questions, each of them using a five-point ordinal scoring system, from which a single summary index can be calculated. For the summary index the scores were standardized from 0 to 100, so that higher scores indicate poorer quality of life."}]}
{"nct_id":"NCT03838159","start_date":"2019-05-15","phase":"Phase 2","enrollment":90,"brief_title":"NADIM II: Neo-Adjuvant Immunotherapy","official_title":"A Randomized Phase II Study of Neo-adjuvant Chemo/Immunotherapy Versus Chemotherapy Alone for the Treatment of Locally Advanced and Potentially Resectable Non-small Cell Lung Cancer (NSCLC) Patients.","primary_completion_date":"2022-03-15","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2027-09-15","last_update":"2021-08-10","description":"This is an open-label, randomised, two-arm, phase II, multi-centre clinical trial. 90 patients will be enrolled in this trial to examine the pathological Complete Response defined as the absence of residual tumor in lung and lymph nodes comparing patients treated with chemo-immunotherapy versus chemotherapy alone.","other_id":"GECP 18/02_NADIM II","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Previously untreated patients with histologically- or cytologically- documented NSCLC\r\n             who present stage IIIA disease (according to 8th version of the International\r\n             Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology) and\r\n             also, potentially resectable locally advanced NSCLC patients' stage IIIB with T3N2\r\n             disease according to 8th edition can be included.\r\n\r\n               -  PET/CT including IV contrast (CT of diagnostic quality) will be performed at\r\n                  baseline (28 days +10 before randomization)\r\n\r\n          2. Tumor should be considered resectable before study entry by a multidisciplinary team\r\n\r\n          3. ECOG (Performance status) 0-1\r\n\r\n          4. Screening laboratory values must meet the following criteria and should be obtained\r\n             within 14 days prior to randomization.\r\n\r\n             i. Neutrophils  1500109/L ii. Platelets  100 x109/L iii. Hemoglobin > 9.0 g/dL iv.\r\n             Serum creatinine  1.5 x ULN or creatinine clearance (CrCl)  40 mL/min v. AST/ALT  3\r\n             x ULN vi. Total Bilirubin  1.5 x ULN (except subjects with Gilbert Syndrome, who can\r\n             have total bilirubin < 3.0 mg/dL) vii. The patients need to have a forced expiratory\r\n             volume (FEV1)  1.2 liters or >40% predicted value viii. INR/APTT within normal limits\r\n\r\n          5. All patients are notified of the investigational nature of this study and signed a\r\n             written informed consent in accordance with institutional and national guidelines,\r\n             including the Declaration of Helsinki prior to any trial-related intervention\r\n\r\n          6. Patients aged > 18 years\r\n\r\n          7. Women of childbearing potential, including women who had their last menstrual period\r\n             in the last 2 years, must have a negative serum or urine pregnancy test within 7 days\r\n             before randomization.\r\n\r\n          8. All sexually active men and women of childbearing potential must use an effective\r\n             contraceptive method (two barrier methods or a barrier method plus a hormonal method)\r\n             during the study treatment and for a period of at least 12 months following the last\r\n             administration of trial drugs\r\n\r\n          9. Patient capable of proper therapeutic compliance and accessible for correct follow-up\r\n\r\n         10. Measurable or evaluable disease (according to RECIST 1.1 criteria)\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. All patients carrying activating mutations in the TK domain of EGFR or any variety of\r\n             alterations in the ALK gene.\r\n\r\n          2. Patients with active, known or suspected autoimmune disease. Subjects with vitiligo,\r\n             type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only\r\n             requiring hormone replacement or unexpected conditions of recurrence in the absence of\r\n             an external trigger are allowed to be included.\r\n\r\n          3. Patients with a condition requiring systemic treatment with either corticosteroids\r\n             (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14\r\n             days of randomization. Inhaled or topical steroids, and adrenal replacement steroid\r\n             doses > 10 mg daily prednisone equivalent, are permitted in the absence of active\r\n             autoimmune disease.\r\n\r\n          4. Patients with a history of interstitial lung disease cannot be included if they have\r\n             symptomatic ILD (Grade 3-4) and/or poor lung function. In case of doubt please contact\r\n             trial team.\r\n\r\n          5. Patients with other active malignancy requiring concurrent intervention and/or\r\n             concurrent treatment with other investigational drugs or anti-cancer therapy\r\n\r\n          6. Patients with previous malignancies (except non-melanoma skin cancers, and the\r\n             following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia,\r\n             melanoma, or breast) are excluded unless a complete remission was achieved at least 2\r\n             years prior to study entry AND no additional therapy is required during the study\r\n             period.\r\n\r\n          7. Any medical, mental or psychological condition which in the opinion of the\r\n             investigator would not permit the patient to complete the study or understand the\r\n             patient information\r\n\r\n          8. Patients who have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2,\r\n             anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell\r\n             costimulation or immune checkpoint pathways\r\n\r\n          9. Patients with positive test for hepatitis B virus surface antigen (HBV sAg) or\r\n             hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic\r\n             infection\r\n\r\n         10. Patients with known history of testing positive for human immunodeficiency virus (HIV)\r\n             or known acquired immunodeficiency syndrome (AIDS)\r\n\r\n         11. Patients with history of allergy to study drug components excipients\r\n\r\n         12. Women who are pregnant or in the period of breastfeeding\r\n\r\n         13. Sexually active men and women of childbearing potential who are not willing to use an\r\n             effective contraceptive method during the study\r\n      ","sponsor":"Fundacin GECP","sponsor_type":"Other","conditions":"Non Small Cell Lung Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Paclitaxel","description":"Paclitaxel must be administered by infusion over 3 hours in dextrose (D5W) or normal saline (NS). The concentration must not exceed 1.2 mg/ml.\r\nThe infusions must be mixed as soon as possible before the start of each infusion since the stability of paclitaxel beyond 24 hours is not known.\r\nIn-line filtration is obligatory since a small number of fibers within the acceptable limits of the USP Particulate Matter Test for LVP have been reported. Cellulose acetate filters of 0.22-micron pore size (such as IVEX II) can be used. The solution that shows excessive particulate matter must be rejected."},{"intervention_type":"Drug","name":"Drug: Carboplatin","description":"Carboplatin must be administered at the end of the Paclitaxel infusion"},{"intervention_type":"Drug","name":"Drug: Nivolumab","description":"Nivolumab is a soluble protein consisting of 4 polypeptide chains, which include 2 identical heavy chains and 2 identical light chains.\r\nThe administration of nivolumab infusion must be completed within 24 hours of preparation."}],"outcomes":[{"outcome_type":"primary","measure":"Evaluation of the pathological complete response (pCR)","time_frame":"From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 45 months.","description":"The pathological complete response is defined as the absence of residual tumor in lung and lymph nodes in patients treated with chemo-immunotherapy versus patients treated with chemotherapy alone."}]}
{"nct_id":"NCT03476109","start_date":"2019-05-10","phase":"Phase 4","enrollment":100,"brief_title":"Study of Magnitude and Prediction of Response to Omalizumab and Mepolizumab in Adult Severe Asthma.","official_title":"Predictive Factors and Magnitude of Response to Omalizumab and Mepolizumab in Allergic and Eosinophilic Severe Asthma: a Pragmatic Multicenter Trial in Belgium.","primary_completion_date":"2020-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-12-31","last_update":"2020-11-03","description":"Pragmatic trial to define the magnitude and the predictive factors of the response to omalizumab and mepolizumab in adult patients with severe refractory asthma and eligible to both therapies.","other_id":"2017/19JUI/325","allocation":"Randomized","intervention_model":"Factorial Assignment","primary_purpose":"Treatment","masking_description":"Single","intervention_model_description":"Severe asthma patients who are eligible to both anti-IgE (omalizumab) and anti-IL-5 (mepolizumab) therapies, will be randomized to decide the first treatment to start. Patients will then be prolonged or switched to the other according to the clinical response. There will be 5 possibilities: oma(lizumab) group, mepo(lizumab) group, oma-mepo switch, mepo-oma switch, and oma/mepo failure.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:  Signed informed consent form (ICF),\r\n\r\n          -  Age >18+ years at time of signing ICF,\r\n\r\n          -  Able to comply with the study protocol, in the investigator's judgment,\r\n\r\n          -  Documented physician-diagnosed asthma ,\r\n\r\n          -  Patients with severe disease and eligible to omalizumab and mepolizumab, and who have\r\n             not yet received any of these therapies.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of evidence of drug/substance abuse that would pose a risk to patient safety,\r\n             interfere with the conduct of study, have an impact on the study results, or affect\r\n             the patient's ability to participate in the study, in the opinion of the investigator\r\n\r\n          -  Treatment with any investigational therapy within 6 months or 5 drug half-lives prior\r\n             to enrolment.\r\n\r\n          -  Known sensitivity to any of the active substances or their excipients to be\r\n             administered during the study.\r\n      ","sponsor":"Cliniques universitaires Saint-Luc- Universit Catholique de Louvain","sponsor_type":"Other","conditions":"Severe Asthma","interventions":[{"intervention_type":"Drug","name":"Drug: Randomisation to omalizumab","description":"The only intervention will be that allocation of patients to omalizumab or mepolizumab (to both of which patients will be eligible) will be randomized, to avoid that the initial decision is biased by confounding factors that are likely, but unproven, to affect the treatment response. Then, in case of non-response, patients will be switched to the other drug, as routine clinical practice would indicate."},{"intervention_type":"Drug","name":"Drug: Randomisation to mepolizumab","description":"The only intervention will be that allocation of patients to omalizumab or mepolizumab (to both of which patients will be eligible) will be randomized, to avoid that the initial decision is biased by confounding factors that are likely, but unproven, to affect the treatment response. Then, in case of non-response, patients will be switched to the other drug, as routine clinical practice would indicate."}],"outcomes":[{"outcome_type":"primary","measure":"Efficacy on asthma symptoms","time_frame":"Up to 22 months","description":"Asthma Control Test: 5 items of score 1 to 5 about symptoms, with result of 20 or above indicates good control; 15 to 19 indicates no good control and below 15 indicates no control at all, and a change of 3 points considered as clinically significant."},{"outcome_type":"primary","measure":"Efficacy on lung function","time_frame":"Up to 22 months","description":"Lung function measured as forced expiratory volume in one sec (FEV1), % predicted value (normal value of 80% predicted or above, and change of 100 mL considered as clinically significant)."},{"outcome_type":"primary","measure":"Efficacy on severe exacerbations","time_frame":"Up to 22 months","description":"Number of exacerbation(s) per period of time (corrected per year) requiring systemic corticosteroid treatment for at least 3 days, and/or emergency visit or hospitalization for acute asthma."},{"outcome_type":"secondary","measure":"Predictive factors of therapeutic response","time_frame":"Baseline features (and according to response at 22 months)","description":"The putative predictive factors of therapeutic response to omalizumab or mepolizumab which will be assayed are the following: age at onset, year (> or < 30yrs); presence of nasal polyps, Y/N; blood eosinophils, n/microliter (< or > 300/microl); serum total IgE, units/L; serum periostin, ng/ml. A proteomic analysis will also be carried out on plasma samples."}]}
{"nct_id":"NCT03359239","start_date":"2019-05-08","phase":"Phase 1","enrollment":15,"brief_title":"Atezolizumab Given in Combination With a Personalized Vaccine in Patients With Urothelial Cancer","official_title":"Pilot Study of Atezolizumab Plus PGV001, a Multipeptide Personalized Neoantigen Vaccine, in Patients With Locally Advanced or Metad or Metastatic Urothelial Cancer","primary_completion_date":"2022-01-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-01-31","last_update":"2021-03-04","description":"The purpose of this study is to determine the good and bad effects of atezolizumab given in combination with a personalized cancer vaccine in patients with urothelial cancer either after surgery to remove organ where the tumor arose (for example, removal of the bladder) or for urothelial cancer that has spread to other organs.","other_id":"GCO 16-1387","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Written informed consent and HIPAA authorization for release of personal health\r\n             information.\r\n\r\n          -  Age  18 years at the time of consent.\r\n\r\n          -  ECOG Performance Status of  1 within fourteen days of registration for protocol\r\n             therapy.\r\n\r\n          -  Histological or cytological evidence of urothelial cancer of the bladder, urethra,\r\n             ureter, or renal pelvis. Differentiation with variant histologies (e.g., squamous cell\r\n             differentiated) or pure variant histologies will be permitted provided that the\r\n             predominant histology is urothelial carcinoma.\r\n\r\n          -  Clinical disease state specific criteria:\r\n\r\n               -  Subjects with invasive urothelial cancer of the bladder or upper urinary tract\r\n                  may consent either before or within 6 weeks after radical cystectomy or\r\n                  nephroureterectomy.\r\n\r\n               -  Subjects with metastatic and/or unresectable disease must have a metastatic site\r\n                  amenable to biopsy. In situations where a metastatic biopsy does not yield\r\n                  sufficient genetic material for sequencing, or a biopsy cannot be feasibly\r\n                  performed, the use of archival tumor tissue may be considered on a case by case\r\n                  basis. The archival tissue must be derived from a muscle-invasive urothelial\r\n                  cancer specimen or metastatic urothelial cancer specimen.\r\n\r\n          -  Required laboratory values must be obtained within thirty days of consent.\r\n\r\n               -  ANC  1500 cells/L\r\n\r\n               -  WBC counts > 2500/L\r\n\r\n               -  Lymphocyte count  300/L\r\n\r\n               -  Platelet count  100,000/L\r\n\r\n               -  Hemoglobin  8.0 g/dL\r\n\r\n               -  Total bilirubin  1.5 x upper limit of normal (ULN) with the following exception:\r\n\r\n                  o Patients with known Gilbert disease who have serum bilirubin level  3 x ULN\r\n                  may be enrolled.\r\n\r\n               -  AST and ALT  3.0 x ULN with the following exception:\r\n\r\n                  o Patients with liver involvement: AST and/or ALT  5 x ULN\r\n\r\n               -  Alkaline phosphatase  2.5 x ULN with the following exception:\r\n\r\n                  o Patients with documented liver involvement or bone metastases: alkaline\r\n                  phosphatase  5 x ULN\r\n\r\n               -  Serum creatinine  1.5 x ULN or creatinine clearance  30 mL/min on the basis of\r\n                  the Cockcroft-Gault glomerular filtration rate estimation:\r\n\r\n               -  (140 - age) x (weight in kg) x (0.85 if female) / 72 x (serum creatinine in\r\n                  mg/dL)\r\n\r\n               -  INR and aPTT  1.5 x ULN o This applies only to patients who do not receive\r\n                  therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such\r\n                  as low-molecular-weight heparin or warfarin) should be on a stable dose.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Known clinically significant liver disease, including active viral, alcoholic, or\r\n             other hepatitis; cirrhosis; fatty liver; and inherited liver disease\r\n\r\n          -  Symptomatic CNS metastases and/or metastases to brain stem, midbrain, pons, medulla,\r\n             cerebellum, or within 10 mm of the optic apparatus (optic nerves and chiasm) and/or\r\n             history of intracranial hemorrhage or spinal cord hemorrhage\r\n\r\n          -  Pregnancy, lactation, or breastfeeding\r\n\r\n          -  Known hypersensitivity to Chinese hamster ovary cell products or other recombinant\r\n             human antibodies\r\n\r\n          -  History or risk of autoimmune disease, including but not limited to systemic lupus\r\n             erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis\r\n             associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjgren's\r\n             syndrome, Bell's palsy, Guillain-Barr syndrome, multiple sclerosis, autoimmune\r\n             thyroid disease, vasculitis, or glomerulonephritis\r\n\r\n          -  Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid\r\n             replacement hormone may be eligible.\r\n\r\n          -  Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be\r\n             eligible.\r\n\r\n          -  Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with\r\n             dermatologic manifestations only (e.g., patients with psoriatic arthritis would be\r\n             excluded) are permitted provided that they meet the following conditions:\r\n\r\n          -  History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced),\r\n             organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing\r\n             pneumonia, etc.), or evidence of active pneumonitis on screening chest computed\r\n             tomography (CT) scan\r\n\r\n             o History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\r\n\r\n          -  History of HIV infection or active hepatitis B (chronic or acute) or hepatitis C\r\n             infection\r\n\r\n          -  Active tuberculosis\r\n\r\n          -  A known additional primary malignancy that is progressing or requires active\r\n             treatment. Exceptions include cancers that have undergone potentially curative\r\n             therapy.\r\n\r\n          -  Medication-Related Exclusion Criteria:\r\n\r\n               -  Prior treatment with anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway\r\n                  targeting agents\r\n\r\n               -  No history of severe immune-related adverse effects from anti-CTLA 4 (NCI CTCAE\r\n                  Grade 3 and 4)\r\n\r\n               -  History of severe allergic, anaphylactic, or other hypersensitivity reactions to\r\n                  chimeric or humanized antibodies or fusion proteins\r\n\r\n               -  Patients with prior allogeneic bone marrow transplantation or prior solid organ\r\n                  transplantation\r\n\r\n        Please contact site for other inclusion/exclusion criteria.\r\n      ","sponsor":"Matthew Galsky","sponsor_type":"Other","conditions":"Urothelial/Bladder Cancer, Nos","interventions":[{"intervention_type":"Drug","name":"Drug: Atezolizumab","description":"1200 mg administered by IV infusion every 3 weeks (21 [+/-2] days) for up to 12 months in the adjuvant setting and up to 24 months in the metastatic setting."},{"intervention_type":"Biological","name":"Biological: PGV001","description":"PGV001: up to ten total doses of PGV001with helper peptides. The product is prepared within the ISMMS . The product consists of two independent preparations of patient specific long peptides mixed with poly-ICLC.\r\nA dose of PGV001 consists of the following:\r\nUp to ten synthetic peptides - 100g (0.01 mL, 10 mg/mL) per peptide. One tetanus helper peptide - 100g (0.01 mL, 10 mg/mL)"},{"intervention_type":"Drug","name":"Drug: Poly ICLC","description":"1.4 mg (0.7 mL, 2 mg/mL)"},{"intervention_type":"Drug","name":"Drug: Normal saline","description":"0.19 mL"}],"outcomes":[{"outcome_type":"primary","measure":"Number of neoantigens","time_frame":"up to 24 months","description":"Feasibility parameter: Number of neoantigens identified per subject"},{"outcome_type":"primary","measure":"Number of peptides synthesized","time_frame":"up to 24 months","description":"Feasibility parameter: Number of peptides synthesized per subject for vaccination"},{"outcome_type":"primary","measure":"Vaccine Production time","time_frame":"up to 24 months","description":"Feasibility parameter:"},{"outcome_type":"primary","measure":"Proportion of consent to tissue acquisition phase","time_frame":"up to 24 months","description":"Feasibility parameter: Proportion of subjects who consent to the tissue acquisition phase for whom a vaccine product is prepared"},{"outcome_type":"primary","measure":"Proportion of subjects eligible for the treatment phase","time_frame":"up to 24 months","description":"Feasibility parameter: Proportion of subjects eligible for the treatment phase who complete the priming course of vaccination plus atezolizumab"},{"outcome_type":"primary","measure":"Number of toxicities","time_frame":"up to 24 months","description":"Safety will be assessed by the frequency of toxicities as assessed by NCI-CTCAE 4.0 criteria"},{"outcome_type":"secondary","measure":"Objective Response Rate","time_frame":"up to 24 hours","description":"Objective Response Rate by RECIST 1.1 . RECIST: complete response, partial response, stable disease, and progressive disease."},{"outcome_type":"secondary","measure":"Duration of response","time_frame":"up to 24 months","description":"The duration of response by RECIST 1.1 and immune-related RECIST criteria in patients with metastatic disease"},{"outcome_type":"secondary","measure":"Time to Progression In Adjuvant patients","time_frame":"up to 24 months","description":"Time-to-progression in adjuvant patients using RECIST: complete response, partial response, stable disease, and progressive disease"},{"outcome_type":"secondary","measure":"Overall Survival","time_frame":"up to 24 months","description":"Number of participants living"}]}
{"nct_id":"NCT03654001","start_date":"2019-05-07","phase":"Phase 3","enrollment":1252,"brief_title":"ALBumin Italian Outcome Septic Shock-BALANCED Trial (ALBIOSS-BALANCED)","official_title":"Efficacy of Albumin Replacement and Balanced Solution in Patients With Septic Shock (the ALBIOSS-BALANCED Trial): a 2-by-2 Factorial, Investigator-initiated, Open- Label, Multicenter, Randomized, Controlled Trial","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-02-28","last_update":"2021-04-23","description":"Septic shock is a devastating condition often observed in ICU. It is characterized by pro-inflammatory and immune responses, organ failures, high incidence of AKI and lethality. Fluid resuscitation is pivotal as supportive therapy. At present, there are no effective therapies to improve survival of such clinical condition, often characterized by a mortality as high as 40% during the first 90 days from diagnosis. This project proposes a large 2-by-2 factorial randomized clinical trial testing the efficacy of albumin and the low- chloride balanced crystalloid solutions (either Ringer Lactate, Ringer Acetate, or Crystalsol - BAL) in septic shock. The investigators have recently concluded a multicenter, randomized trial, the ALBIOS trial, in which, in a post-hoc analysis, albumin, in addition to crystalloids, reduced 90-day mortality in patients with septic shock, as compared to crystalloids alone (Caironi P et al, 2014). Crystalloids with supra-physiological chloride content may deteriorate renal perfusion, increasing the risk of acute kidney injury (AKI) and mortality.","other_id":"RF-2016-02361583","allocation":"Randomized","intervention_model":"Factorial Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"2-by-2 factorial design, open-label, multicenter, randomized, controlled trial, in patients with septic shock, as defined according to clinical criteria. Patients will be randomized in a 1:1:1:1 ratio to one of the 4 groups (Albumin + BAL, Albumin + NS, BAL, NS).","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":100,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Patients with septic shock if they meet the two following criteria:\r\n\r\n          1. Presence of an infection (known or suspected) in at least one site:\r\n\r\n               1. Lung\r\n\r\n               2. Abdomen\r\n\r\n               3. Urinary tract\r\n\r\n               4. Others (blood, skin and soft tissues, central nervous system, bones and joints,\r\n                  cardiac system, reproductive organs).\r\n\r\n          2. Presence of a severe and acute, sepsis-related cardiovascular failure (as assessed by\r\n             the SOFA score - see Annex 1), requiring vasopressor to maintain mean arterial\r\n             pressure >=65 mmHg, despite adequate volume resuscitation a) Cardiovascular SOFA score\r\n             > 2 (3 or 4) If the patient is unable to provide informed consent, she/he can be\r\n             included in the trial provided that the requirements of ongoing laws are fulfilled;\r\n             details on this approach are provided in the protocol, par 11.1 and related Annex 3.\r\n             The patient will be informed about having been included in a clinical trial, as soon\r\n             as she/he will regain consciousness.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Age < 18 years\r\n\r\n          2. Moribund state\r\n\r\n          3. Known or suspected adverse reaction to albumin administration\r\n\r\n          4. Septic shock in patients with traumatic brain injury or a clinically active cerebral\r\n             lesion (known or suspected)\r\n\r\n          5. Severe congestive heart failure (NYHA III and IV classes)\r\n\r\n          6. Clinical situations in which the use of albumin is known or supposed to be clinically\r\n             beneficial (hepatic cirrhosis with ascites, malabsorption syndrome or protein-losing\r\n             enteropathy, nephrotic syndrome, burns)\r\n\r\n          7. More than 24 hours after the onset of septic shock\r\n\r\n          8. Religious objection to the administration of human blood products\r\n\r\n          9. Presence of chronic end-stage renal disease\r\n\r\n         10. Severe hyperkalemia\r\n\r\n         11. Enrollment in other experimental interventional studies\r\n      ","sponsor":"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico","sponsor_type":"Other","conditions":"Septic Shock","interventions":[{"intervention_type":"Biological","name":"Biological: Albumin","description":"Human Albumin In parallel with fluid administration for volume resuscitation, patients will receive 400 ml of 20% albumin solution both at randomization (D0) and at day 1 (D1). Subsequently, from day 2 (D2) until day 90 (D90) or ICU discharge (whichever comes first), 20% albumin will be administered on a daily basis, to maintain serum albumin concentration equal to or greater than 30 g/L, based upon serum albumin determination."},{"intervention_type":"Other","name":"Other: Balanced","description":"Balanced crystalloid solutions are traditionally crystalloid solutions containing a relatively low concentration of chloride as compared to 0.9% NaCl containing solutions (Normal Saline)."}],"outcomes":[{"outcome_type":"primary","measure":"All-cause 90-day mortality","time_frame":"Up to 90 days","description":"All-cause death from randomization to 90 days"},{"outcome_type":"primary","measure":"Combined co-primary endpoint","time_frame":"Up to 90 days","description":"The composite of all-cause death from randomization to 90 days and new occurrence of acute kidney injury (AKI)."},{"outcome_type":"secondary","measure":"ICU mortality","time_frame":"Up to ICU discharge, a median of 9 days","description":"All-cause death occurring in Intensive Care Unit (ICU)"},{"outcome_type":"secondary","measure":"In-hospital mortality","time_frame":"Up to hospital discharge, a median of 20 days","description":"All-cause death occurring during hospital stay"},{"outcome_type":"secondary","measure":"1-year mortality","time_frame":"Up to 1 year","description":"All-cause death from randomization to 1 year"},{"outcome_type":"secondary","measure":"SOFA score","time_frame":"Up to 90 days or ICU discharge - a median of 9 days - whichever comes first","description":"Severity and incidence of organ failures, as assessed by the Sequential Organ Failure Assessment (SOFA) score. SOFA score is used to determine the extent of organ function in a patient while in the intensive care unit. The score is based on 6 different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. The scale of each score ranges from 0 (no dysfunction) to 4 (maximal dysfunction). The 6 scores are then added up to provide a global score: the highest the value, the worst the condition of the patient."},{"outcome_type":"secondary","measure":"Incidence of AKI","time_frame":"Up to 90 days or ICU discharge - a median of 9 days - whichever comes first","description":"Assessed by the Kidney Disease Improving Global Outcome (KDIGO) criteria as any of the following: (1) increase in serum creatinine >=0.3 mg/dl (26.5 mmol/l) within 48 hours; or (2) increase in SCr to >=1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or (3) urine volume <0.5 ml/kg/h for 6 hours."},{"outcome_type":"secondary","measure":"RRT","time_frame":"Up to 90 days or ICU discharge - a median of 9 days - whichever comes first","description":"First use of Renal Replacement Therapy (RRT) during ICU stay"},{"outcome_type":"secondary","measure":"Need for vasopressors","time_frame":"Up to 90 days or ICU discharge - a median of 9 days - whichever comes first","description":"Duration of the need for vasopressors during ICU stay"},{"outcome_type":"secondary","measure":"Mechanical ventilation","time_frame":"Up to 90 days or ICU discharge - a median of 9 days - whichever comes first","description":"Duration of mechanical ventilation during ICU stay"},{"outcome_type":"secondary","measure":"Secondary infections in ICU","time_frame":"Up to 90 days or ICU discharge - a median of 9 days - whichever comes first","description":"Incidence of secondary-acquired infections during ICU stay"},{"outcome_type":"secondary","measure":"Duration of stay in ICU","time_frame":"Up to ICU discharge, a median of 9 days","description":"Duration expressed as number of days spent in ICU"},{"outcome_type":"secondary","measure":"Duration of stay in hospital","time_frame":"Up to hospital discharge, a median of 20 days","description":"Duration expressed as number of days spent in hospital"},{"outcome_type":"other","measure":"Severe metabolic acidosis","time_frame":"Up to 90 days or ICU discharge - a median of 9 days - whichever comes first","description":"Incidence of severe metabolic acidosis"},{"outcome_type":"other","measure":"Severe hyperkalemia","time_frame":"Up to 90 days or ICU discharge - a median of 9 days - whichever comes first","description":"Incidence of severe hyperkalemia"}]}
{"nct_id":"NCT03893565","start_date":"2019-05-06","phase":"Phase 2","enrollment":104,"brief_title":"Safety, Tolerability, Efficacy and Dose-response of GSK2831781 in Ulcerative Colitis","official_title":"A Multicentre Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Safety, Tolerability, Efficacy, Dose-response, Pharmacokinetics and Pharmacodynamics of Repeat Dosing of an Anti-LAG3 Cell Depleting Monoclonal Antibody (GSK2831781) in Patients With Active Ulcerative Colitis","primary_completion_date":"2021-05-17","study_type":"Interventional","rec_status":"Terminated","completion_date":"2021-05-17","last_update":"2021-06-24","description":"This is a Phase 2, multicenter, randomized, double-blind, parallel group, placebo-controlled study to investigate the safety, tolerability, efficacy and dose-response of GSK2831781 in participants with moderate to severe active ulcerative colitis. The study consists of a 5-week screening window, 10-week Induction Phase, 30-week double-blind Extended Treatment Phase (ETP) with 42-week Follow-Up Phase. Non-Responders identified following the Week 10 assessment will be allocated to open label treatment, consisting of Induction (Weeks 12 to 22), an Open label ETP (Weeks 22 to 42) and a follow-Up to Week 54.","other_id":"204869","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","intervention_model_description":"This is a parallel group, placebo controlled study where participants will be randomized to receive either GSK2831781 or placebo.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Participants must be 18 years of age or older and > 40 kilograms (kg) at the time of\r\n             signing the informed consent.\r\n\r\n          -  Participants who have a diagnosis of ulcerative colitis, established at least 3 months\r\n             prior to screening, as documented by diagnostic sigmoidoscopy or colonoscopy, and\r\n             biopsy.\r\n\r\n          -  Complete 4-domain Mayo Score of 6 to 12, with disease extending >= 15 centimeters (cm)\r\n             from the anal verge, with a centrally read endoscopic sub score of >=2 at screening\r\n             endoscopy, and a rectal bleeding sub score >=1.\r\n\r\n          -  A history of at least one of the following: inadequate response to, loss of response\r\n             to, or intolerance to azathioprine or mercaptopurine (including thiopurine\r\n             methyltransferase [TPMT] and nudix hydrolase 15 [NUDT15] genetic mutations precluding\r\n             use), ciclosporin, tacrolimus or methotrexate; inadequate response to, loss of\r\n             response to, intolerance to, or demonstrated dependence on oral corticosteroids;\r\n             inadequate response to, loss of response to, or intolerance to at least one approved\r\n             advanced therapy for UC including anti- tumor necrosis factor (TNF) therapies (example\r\n             given [e.g.] infliximab, adalimumab, golimumab, or biosimilar), anti-integrin\r\n             therapies, anti-interleukin (IL)-12/23 monoclonal antibodies or Janus Kinase (JAK)\r\n             inhibitors.\r\n\r\n          -  Surveillance colonoscopy (performed according to local standards) within 12 months of\r\n             screening (or during screening, if required) for participants with: Pancolitis of >8\r\n             years duration; or participants with left-sided colitis of >12 years duration. For\r\n             participants for whom this criterion does not apply, colorectal cancer surveillance\r\n             should be undertaken according to local or national guidelines for participants with\r\n             age >=50, or with other known risk factors for colorectal cancer.\r\n\r\n          -  Both male and female participants are eligible to participate.\r\n\r\n          -  A female participant is eligible to participate if she is not pregnant, not\r\n             breastfeeding, and at least one of the following conditions applies: Not a woman of\r\n             childbearing potential (WOCBP); A WOCBP who agrees to use a highly effective\r\n             contraceptive method for at least 4 weeks prior to dosing, until the Follow-Up visit.\r\n\r\n          -  Capable of giving signed informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Participants with a current diagnosis of indeterminate colitis, inflammatory bowel\r\n             disease-unclassified, Crohn's disease, infectious colitis, or ischemic colitis.\r\n\r\n          -  Participants with fulminant ulcerative colitis (as defined by 6 bloody stools daily\r\n             and 1 or more of body temperature >=100.4 degrees Fahrenheit (or 38 degree Celsius) or\r\n             heart rate >90 beats per minute), or toxic megacolon.\r\n\r\n          -  Prior extensive colonic resection, subtotal or total colectomy, or proctocolectomy, or\r\n             planned surgery for ulcerative colitis.\r\n\r\n          -  Participants with any uncontrolled medical conditions, other than active ulcerative\r\n             colitis, that in the opinion of the investigator put the participant at unacceptable\r\n             risk or interfere with study assessments or integrity of the data. Other medical\r\n             conditions should be stable at the time of screening and be expected to remain stable\r\n             for the duration of the study.\r\n\r\n          -  Unstable lifestyle factors, such as alcohol use to excess or recreational drug use, to\r\n             the extent that in the opinion of the investigator they would interfere with the\r\n             ability of a participant to complete the study.\r\n\r\n          -  An active infection or a history of serious infections as follows: a) Use of\r\n             antimicrobials (antibacterials, antivirals, antifungals or antiparasitic agents) for\r\n             an infection within 30 days before first dose (topical treatments may be allowed at\r\n             the Medical Monitor's discretion). b) A history of opportunistic infections within 1\r\n             year of screening (e.g. Pneumocystis jirovecii, aspergillosis or Cytomegalovirus\r\n             colitis). This does not include infections that may occur in immunocompetent\r\n             individuals, such as fungal nail infections or vaginal candidiasis, unless it is of an\r\n             unusual severity or recurrent nature. c) Recurrent or chronic infection or other\r\n             active infection that, in the opinion of the Investigator, might cause this study to\r\n             be detrimental to the participant. d) Symptomatic herpes zoster within 3 months prior\r\n             to screening. e) History of tuberculosis (active or latent), irrespective of treatment\r\n             status. f) A positive diagnostic tuberculosis test at screening (defined as a positive\r\n             QuantiFERON test). In cases where the QuantiFERON test is indeterminate, the\r\n             participant may have the test repeated once and if their second test is negative they\r\n             will be eligible. In the event a second test is also indeterminate, the investigator\r\n             has the option to undertake Purified Protein Derivative (PPD) testing. If the PPD\r\n             reaction is less than (<) 5 millimeter (mm), then the participant is eligible. If the\r\n             reaction is >= 5mm, or PPD testing is not undertaken, the participant is not eligible.\r\n             g) Positive Clostridium difficile toxin test during screening. However, rescreening\r\n             can be undertaken following successful treatment.\r\n\r\n          -  Current or history of chronic liver or biliary disease (with the exception of\r\n             Gilbert's syndrome, asymptomatic gallstones or uncomplicated fatty liver disease).\r\n\r\n          -  Hereditary or acquired immunodeficiency disorder, including immunoglobulin deficiency\r\n             (unless the participant has a documented history of selective immunoglobulin A\r\n             deficiency).\r\n\r\n          -  A major organ transplant (e.g. heart, lung, kidney, liver, pancreas) or hematopoietic\r\n             stem cell/marrow transplant.\r\n\r\n          -  Any planned major surgical procedure during the study.\r\n\r\n          -  A history of malignant neoplasm within the last 5 years, except for adequately treated\r\n             non-metastatic basal or squamous cell cancers of the skin (within 1 year) or carcinoma\r\n             in situ of the uterine cervix (within 3 years) that has been fully treated and shows\r\n             no evidence of recurrence.\r\n\r\n          -  A change in dose of oral sulfasalazine or aminosalicylate within 2 weeks prior to\r\n             Baseline endoscopy.\r\n\r\n          -  Greater than 20 mg per day oral prednisolone (or equivalent), or a change in dose of\r\n             corticosteroid within 2 weeks prior to Baseline endoscopy, or anticipated inability to\r\n             maintain a stable dose of corticosteroids (<=20 mg oral prednisolone or equivalent)\r\n             until Week 12.\r\n\r\n          -  Topical (rectal) corticosteroids or topical (rectal) aminosalicylate within 2 weeks\r\n             prior to Baseline endoscopy.\r\n\r\n          -  Initiation or a change in dose of mercaptopurine or azathioprine (including initiation\r\n             or discontinuation of allopurinol) or methotrexate within 8 weeks prior to Baseline\r\n             endoscopy.\r\n\r\n          -  Treatment with ciclosporin, tacrolimus or thalidomide within 4 weeks prior to Baseline\r\n             endoscopy.\r\n\r\n          -  Treatment with an anti-TNF biologic within 8 weeks prior to Baseline endoscopy,\r\n             anti-integrin or anti-IL-12/23 biologics within 12 weeks prior to Baseline endoscopy,\r\n             or a JAK inhibitor within 4 weeks prior to Baseline endoscopy.\r\n\r\n          -  A history of inadequate response, loss of response, or intolerance to more than three\r\n             classes of approved advanced therapies for UC (including anti-TNF therapies,\r\n             anti-integrin therapies, anti-IL-12/23 monoclonal antibodies, or JAK inhibitors; but\r\n             excluding exposure within a clinical trial setting), of which participants must not\r\n             have had inadequate response (primary non-response) to more than two classes.\r\n\r\n          -  Received fecal microbiota transplantation within 4 weeks prior to Baseline endoscopy.\r\n\r\n          -  Received live vaccination within 4 weeks of Day 1 or plan to receive during the study\r\n             until Follow-Up.\r\n\r\n          -  The participant has participated in a clinical trial and has received an\r\n             investigational product within the following time period prior to the screening\r\n             endoscopy day in the current study:\r\n\r\n               1. Biologics: 3 months, 5 half-lives, or twice the duration of the biological effect\r\n                  of the investigational product (whichever is longer);\r\n\r\n               2. New Chemical Entities (NCEs): 30 days, 5 half-lives, or twice the duration of the\r\n                  biological effect (whichever is longer).\r\n\r\n          -  Absolute neutrophil count <1.5 times 10^9 cells per liter (L) or a hemoglobin <80\r\n             grams per liter (g/L) or lymphocyte count <0.8 times 10^9 cells /L.\r\n\r\n          -  Estimated glomerular filtration rate (GFR) by Chronic Kidney Disease Epidemiology\r\n             Collaboration equation (CKD-EPI) calculation <60 milliliter (mL) per minute per 1.73\r\n             m^2 at screening.\r\n\r\n          -  ALT >2 times upper limit of normal (ULN) and bilirubin >1.5 times ULN (isolated\r\n             bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct\r\n             bilirubin <35 percent) at screening.\r\n\r\n          -  Other clinically significant abnormalities of laboratory assessments, as judged by the\r\n             investigator and/or GlaxoSmithKline Medical Monitor that could affect the safety of\r\n             the participant, or the interpretation of the data from the study.\r\n\r\n          -  Presence of hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb),\r\n             or positive hepatitis C antibody result at screening (Nota bene [NB]-Participants with\r\n             Hepatitis C antibody due to prior resolved disease can be enrolled only if a\r\n             confirmatory negative Hepatitis C ribonucleic acid [RNA] test is obtained).\r\n\r\n          -  Positive serology for human immunodeficiency virus (HIV) at screening.\r\n\r\n          -  Where participation in the study would result in donation of blood or blood products\r\n             in excess of 500 mL within 3 months.\r\n\r\n          -  QTc >450 milliseconds (msec) or QTc >480 msec for participants with bundle branch\r\n             block at screening and Day 1. The QTc is the QT interval corrected for heart rate\r\n             according to either Bazett's formula (QTcB), Fridericia's formula (QTcF), or another\r\n             method, machine or over read.\r\n\r\n          -  Participants with hypersensitivity to GSK2831781 or any excipients in the clinical\r\n             formulation of GSK2831781.\r\n      ","sponsor":"GlaxoSmithKline","sponsor_type":"Industry","conditions":"Colitis, Ulcerative","interventions":[{"intervention_type":"Drug","name":"Drug: GSK2831781 - Double Blind Phase","description":"GSK2831781 will be administered intravenously in the double blind induction phase and subcutaneously in the double blind ETP (both according to randomization)."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo (commercial saline solution) will be administered intravenously in the double blind induction phase and subcutaneously in the double blind ETP (both according to randomization)."},{"intervention_type":"Drug","name":"Drug: GSK2831781 - Open Label phase","description":"GSK2831781 will be administered intravenously in the open label induction phase and subcutaneously in the open label ETP."}],"outcomes":[{"outcome_type":"primary","measure":"Number of participants with adverse events (AEs) and serious adverse events (SAEs) in the Double Blind Induction Phase","time_frame":"Up to Week 14","description":"AEs and SAEs will be collected."},{"outcome_type":"primary","measure":"Number of participants with findings of potential clinical importance for vital signs, clinical laboratory parameters and QT interval corrected (QTc) in the Double Blind Induction Phase.","time_frame":"Up to Week 14","description":"Blood and urine samples will be collected for the analysis of clinical laboratory parameters, vital signs and QTc interval for heart rate"},{"outcome_type":"primary","measure":"Change from Baseline in Complete 4-domain Mayo Clinic Score at Week 10","time_frame":"Baseline and at Week 10","description":"The Complete Mayo Score is a 12-point scoring system where disease is evaluated based on stool frequency, rectal bleeding, physician global assessment (PGA) and endoscopic appearance (with mild friability associated with an endoscopic score of 1). Each subscale is scored on a scale of 0 to 3, where 0 = normal condition and 3 = severe disease condition."},{"outcome_type":"secondary","measure":"Number of participants with AEs and SAEs in the double blind ETP","time_frame":"Up to Week 42","description":"AEs and SAEs will be collected."},{"outcome_type":"secondary","measure":"Number of participants with findings of potential clinical importance for vital signs, clinical laboratory parameters and QTc in the double blind ETP","time_frame":"Up to Week 42","description":"Blood and urine samples will be collected for the analysis of clinical laboratory parameters, vital signs and QTc interval for heart rate."},{"outcome_type":"secondary","measure":"Number of participants with adapted Mayo endoscopic score of 0 or 1 at Week 10","time_frame":"At Week 10","description":"The Adapted Mayo Score is a 9-point scoring system where disease is evaluated based on stool frequency, rectal bleeding and endoscopic appearance (with any friability associated with an endoscopic score of 2 or 3).The scores will range from 0 (Normal or inactive disease) to 3 (Severe disease or spontaneous bleeding, ulceration)."},{"outcome_type":"secondary","measure":"Number of participants with adapted Mayo clinical remission at Week 10","time_frame":"At Week 10","description":"Clinical remission is defined as an adapted Mayo Clinical Response of less than or equal to (<=) 2, with no individual sub score greater than (>) 1 and a rectal bleeding subscore of 0 and stool frequency subscore <=1 and not greater than Baseline at Week 10."},{"outcome_type":"secondary","measure":"Number of participants with adapted Mayo Clinical Response at Week 10","time_frame":"At Week 10","description":"Clinical response is defined as reduction in adapted Mayo Clinical Response greater than or equal to (>=) 2 points from Baseline and >=30 percent from Baseline and a decrease in the rectal bleeding score of >=1 point from Baseline or a score of 0 or 1."},{"outcome_type":"secondary","measure":"Number of participants with symptomatic remission over time","time_frame":"Up to Week 10","description":"Symptomatic remission is defined as a rectal bleeding sub-score of 0, and a stool frequency sub-score of <=1, with no worsening from Baseline"},{"outcome_type":"secondary","measure":"Change from Baseline in partial Mayo score over time","time_frame":"Baseline and up to Week 10","description":"Clinical disease assessments will be undertaken using the partial Mayo Score. It consists of 3 subscales: stool frequency, rectal bleeding, and/or physician's global assessment of disease activity. Each subscale is scored on a scale of 0 to 3, where 0 = normal condition and 3 = severe disease condition."},{"outcome_type":"secondary","measure":"Change from Baseline in adapted Mayo endoscopic score and Ulcerative Colitis Endoscopic Index of Severity (UCEIS) at Week 10","time_frame":"Baseline and up to Week 10","description":"Improvement in endoscopic assessment of mucosal inflammation in ulcerative colitis will be determined by adapted Mayo endoscopic score on a scale ranging from 0 (Normal or inactive disease) to 3 (Severe disease or spontaneous bleeding, ulceration). The Adapted Mayo Score is a 9-point scoring system where disease is evaluated based on stool frequency, rectal bleeding and endoscopic appearance (with any friability associated with an endoscopic score of 2 or 3). UCEIS will be used as an additional tool to assess disease activity based on endoscopic vascular pattern, bleeding, erosions and ulcerations. Each item has 3 or 4 levels of severity and is given a score. The scores for each individual item are combined into a total score ranging from 0 to 8. A higher score indicates increased endoscopic severity of Ulcerative Colitis."},{"outcome_type":"secondary","measure":"Histological severity as determined by Robarts Histopathology Index at Week 10","time_frame":"At Week 10","description":"Robarts Histopathology Index will be assessed by central reading of gut pinch biopsies. Key domains for scoring of the indices include chronic inflammatory infiltrate; neutrophils in the epithelium, lamina propria neutrophils, erosion and ulceration scored from 0 to 3 and multiplied by a weighting factor. The total Robarts Histopathology Index score is calculated by summing the weighted scores of the histological items, with total scores ranging from 0 (no disease activity) to 33 (severe disease activity)."},{"outcome_type":"secondary","measure":"Histological severity as determined by the Nancy Histological Index at Week 10","time_frame":"At Week 10","description":"The Nancy Histopathology Index will be assessed by central reading of gut pinch biopsies. Key domains for scoring of the indices include chronic inflammatory infiltrate; neutrophils in the epithelium, lamina propria neutrophils, erosion and ulceration scored from 0 to 3 and multiplied by a weighting factor. The total Nancy Histopathology Index score is calculated by summing the weighted scores of the histological items, with total scores ranging from 0 (no disease activity) to 33 (severe disease activity)."},{"outcome_type":"secondary","measure":"Histological severity as determined by Geboes Histological Index at Week 10","time_frame":"At Week 10","description":"Geboes Histopathology Index will be assessed by central reading of gut pinch biopsies. Geboes Histopathology Index is scored from 0 to 3. Lower values represents better outcome."},{"outcome_type":"secondary","measure":"Change from Baseline in serum C reactive protein over time","time_frame":"Baseline and up to Week 10","description":"A blood sample will be collected for analysis of C reactive protein to characterize the impact of GSK2831781."},{"outcome_type":"secondary","measure":"Change from Baseline in fecal calprotectin over time","time_frame":"Baseline and up to Week 10","description":"Fecal samples will be collected for analysis of calprotectin to characterize the impact of GSK2831781 on this biomarker of intestinal inflammation."},{"outcome_type":"secondary","measure":"Area under the concentration-time curve over the dosing interval (AUC [0-tau]) of GSK2831781","time_frame":"Up to Day 379","description":"Blood samples will be collected for the concentrations of GSK2831781."},{"outcome_type":"secondary","measure":"Maximum observed plasma concentration (Cmax) of GSK2831781","time_frame":"Up to Day 379","description":"Blood samples will be collected for the concentrations of GSK2831781."},{"outcome_type":"secondary","measure":"Time to reach Cmax (Tmax) of GSK2831781","time_frame":"Up to Day 379","description":"Blood samples will be collected for the concentrations of GSK2831781."},{"outcome_type":"secondary","measure":"Number of participants with anti-drug antibodies at each visit","time_frame":"Up to Week 10","description":"Serum samples will be assessed for the presence of anti-drug antibodies."}]}
{"nct_id":"NCT04166786","start_date":"2019-05-06","phase":"Phase 1","enrollment":4,"brief_title":"Steroid Profile: Differentiating Testosterone Administration From (Simultaneous) Ethanol Consumption","official_title":"Steroid Profile: Differentiating Testosterone Administration From (Simultaneous) Ethanol Consumption: Evaluation of Newly Developed Markers","primary_completion_date":"2019-09-26","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-09-26","last_update":"2019-11-18","description":"Background: Testosterone is an anabolic steroid widely known to improve physical performance. Its consumption is banned by the World Anti-Doping Agency (WADA). The steroid profile is one of the components of the Athlete's Biological Passport (ABP), which consists of selected biological variables that indirectly reveal the effects of doping. Alcohol consumption has been proved to alter the steroid profile and this may lead to the use of ethanol as a masking agent for testosterone administration. Hypothesis: Ratios of different testosterone biomarkers vary after ethanol administration: [6-hydroxy-androsterone-3-glucuronide (6OH-Andros3G) / epitestosterone-glucuronide (EG)] and [6-hydroxy-etiocholanolone-3-glucuronide (6OH-Etio3G) / EG] decrease, while [testosterone-glucuronide (TG) / EG] increases. Primary objective: To evaluate if the combination of the markers TG, EG, 6OH-Andros3G and 6OH-Etio3G, as well as ethyl glucuronide (EtG) and ethyl sulfate (EtS), can be routinely used to differentiate between changes in the steroid profile due exclusively to the consumption of alcohol and those produced when alcohol is consumed during a testosterone administration. Secondary objectives: 1. To explore the potential of the simultaneous determination of both phase I and phase II metabolites in alternative matrices (plasma from blood samples collected as for the haematological module of ABP, or saliva) in the screening of testosterone misuse. 2. To look for the differences into a comprehensive steroid profile (determined in urine, plasma and saliva) between samples collected after testosterone administration and after the combination of testosterone and ethanol. Methods: Phase I, single-blind, crossover-design clinical trial, placebo controlled, with 4 conditions randomly assigned in male healthy caucasian subjects with a wash-out period between treatments.","other_id":"IMIMFTCL/SPOL/1","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Other","masking_description":"Single","intervention_model_description":"Subjects receive 4 different treatment conditions (testosterone+ethanol placebo, ethanol+testosterone placebo, testosterone+ethanol, and placebo testosterone+placebo ethanol), separated by a wash-out period of 15 days. The order of the treatment conditions is randomly assigned.","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy Caucasian men aged 18 to 40 years.\r\n\r\n          -  Clinical history and physical examination demonstrating no organic or psychiatric\r\n             disorders.\r\n\r\n          -  The ECG and general blood and urine laboratory tests performed before the study should\r\n             be within normal ranges. Minor or occasional changes from normal ranges are accepted\r\n             if, in the investigator's opinion, considering the current state of the art, they are\r\n             not clinically significant, are not life-threatening for the subjects and do not\r\n             interfere with the product assessment. These changes and their non-relevance will be\r\n             justified in writing specifically.\r\n\r\n          -  The body mass index (BMI=weigh/height2) will range from 19 to 27 kg/m2, and the weight\r\n             from 50 to 100 kg.\r\n\r\n          -  Understanding and accepting the study procedures and signing the informed consent.\r\n\r\n          -  Agreeing to follow a diet free from ethanol in the 72 hours prior to the start of each\r\n             session and until the end of the study.\r\n\r\n          -  Subjects with social or recreational alcohol consumption, at least 3 Standard\r\n             Drink/week and subjects with experience in several drunkenness.\r\n\r\n          -  Volunteers with normal steroidal profile for Caucasian population (0.7 T / E 3)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Not meeting the inclusion criteria.\r\n\r\n          -  Allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active substance\r\n             of Testogel gel, which is synthesized from soy, or to any of the excipients or to\r\n             vaseline ointment.\r\n\r\n          -  Subjects with intolerance or adverse reactions to ethanol.\r\n\r\n          -  History or clinical evidence of alcoholism, drug abuse, or regular use of psychoactive\r\n             drugs.\r\n\r\n          -  History or clinical evidence of cardiovascular, respiratory, renal, hepatic,\r\n             endocrine, gastrointestinal, hematological, neurological, dermatological or other\r\n             acute or chronic diseases that, in the opinion of the Principal Investigator or the\r\n             collaborators designated by it, may pose a risk to the subjects or interfere with the\r\n             objectives of the study. Especially history of epilepsy and migraine, edema,\r\n             hypertension, diabetes mellitus, hypercalcemia or polyglobulia.\r\n\r\n          -  History of psychiatric disorders.\r\n\r\n          -  History or clinical evidence of gastrointestinal, liver, renal or other disorders\r\n             which may lead to suspecting a disorder in drug absorption, distribution, metabolism\r\n             or excretion, or that suggest gastrointestinal irritation due to drugs.\r\n\r\n          -  Subjects with contraindications to treatment with the study drugs (according to the\r\n             respective technical data sheets). Especially a history of breast cancer, liver\r\n             cancer, suspicion or confirmation of prostate carcinoma Subjects and subjects who have\r\n             suffered a hospitalization caused by alcohol intoxication or who have received\r\n             treatment for drunkenness\r\n\r\n          -  Having suffered any organic disease or major surgery in the three months prior to the\r\n             study start.\r\n\r\n          -  Symptoms compatible with a prostatic syndrome: increase in the number of urinations,\r\n             difficulty to initiate urination, thinner and less potent urine stream, urination in\r\n             several times, incomplete emptying of urine feeling.\r\n\r\n          -  Prostate-specific antigen (PSA) values outside the normal range for the volunteer's\r\n             age.\r\n\r\n          -  Subjects with positive serology to Hepatitis B, C or HIV.\r\n\r\n          -  Presence of bacterial, fungal or deep cuts in the area of skin chosen for cutaneous\r\n             applications.\r\n\r\n          -  Regular use of any drug in the month prior to the study sessions. The treatment with\r\n             single or limited doses of symptomatic medicinal products in the week prior to the\r\n             study sessions will not be a reason for exclusion if it is calculated that it has been\r\n             cleared completely the day of the experimental session.\r\n\r\n          -  Blood donation 8 weeks before or participation in other clinical trials with drugs in\r\n             the previous 12 weeks.\r\n\r\n          -  Smokers of more than 20 cigarettes per day.\r\n\r\n          -  Taking more than 40 g of alcohol a day\r\n\r\n          -  Consumers of more than 5 coffees, teas, cola drinks, or other stimulant drinks or with\r\n             xanthines daily in the 3 months prior to the start of the study.\r\n\r\n          -  Ingestion of vitamin supplements or antioxidants or Non-Steroidal Anti-Inflammatory\r\n             Drugs (NSAID) in the two weeks preceding the study.\r\n\r\n          -  Subjects unable to understand the nature, consequences of the study and the procedures\r\n             requested to be followed.\r\n      ","sponsor":"Parc de Salut Mar","sponsor_type":"Other","conditions":"Healthy Volunteers","interventions":[{"intervention_type":"Drug","name":"Drug: Testosterone gel","description":"Subjects receive a daily transdermal dose of 100 mg of testosterone (2 sachets of 5 g of gel) during 3 days."},{"intervention_type":"Drug","name":"Drug: Ethanol Solution","description":"Subjects receive a daily administration of 30 g of ethanol (94 mL of Vodka Absolut diluted in 300 mL of lemon-flavoured water Fontvella) during 3 days."},{"intervention_type":"Drug","name":"Drug: Testosterone placebo (vaseline)","description":"Subjects receive a daily transdermal dose of 5 g of pure vaseline ointment during 3 days."},{"intervention_type":"Drug","name":"Drug: Ethanol placebo (lemon-flavoured water)","description":"Subjects receive a daily administration of 394 mL of lemon-flavored-water Fontvella during 3 days."}],"outcomes":[{"outcome_type":"primary","measure":"Change in steroid profile in urine","time_frame":"From baseline (pre-administration) to 48 hours after last administration (fractions: 0-2, 2-4, 4-6, 6-8, 8-24 hours each day, and 24-48 hours post-administration last day)","description":"Variation of the concentration of different endogenous steroids (testosterone, epitestosterone, androsterone, etiocholanolone, 3a,5a-androstanediol, 3a,5b-androstanediol, DHEAS, 5PTS, 5PDS, PTG, PDG) in urine before and after treatment administration."},{"outcome_type":"primary","measure":"Change in new steroid profile markers in plasma","time_frame":"From baseline (pre-administration) to 8 hours post-administration (at 0, 2, 4, 6, 8 hours each day)","description":"Variation of the concentration of new steroid profile markers (6OH-Andros3G, 6OH-Etio3G, testosterone free TG, Andros, Andros3G, Etio, Etio3G) in plasma before and after treatment administration."},{"outcome_type":"primary","measure":"Change in new steroid profile markers in saliva","time_frame":"From baseline (pre-administration) to 8 hours post-administration (at 0, 2, 4, 6, 8 hours each day)","description":"Variation of the concentration of new steroid profile markers (6OH-Andros3G, 6OH-Etio3G, testosterone free TG, Andros, Andros3G, Etio, Etio3G) in saliva before and after treatment administration."},{"outcome_type":"primary","measure":"Change in Ethyl glucuronide in urine","time_frame":"From baseline (pre-administration) to 48 hours post-administration (fractions: 0-2, 2-4, 4-6, 6-8, 8-24, 24-48 hours)","description":"Variation of the concentration of Ethyl glucuronide in urine before and after treatment administration."},{"outcome_type":"primary","measure":"Change in Ethyl sulfate in urine","time_frame":"From baseline (pre-administration) to 48 hours post-administration (fractions: 0-2, 2-4, 4-6, 6-8, 8-24, 24-48 hours)","description":"Variation of the concentration of Ethyl sulfate in urine before and after treatment administration."}]}
{"nct_id":"NCT03494751","start_date":"2019-05-01","phase":"N/A","enrollment":358,"brief_title":"Heart Monitoring Device After Acute Myocardium Infarction","official_title":"Heart Monitoring Device After Acute Myocardium Infarction","primary_completion_date":"2019-09-01","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2020-07-01","last_update":"2019-04-08","description":"Verify the effectiveness of a Heart Monitor in preventing events in patients over 18 years after acute myocardial infarction in a clinical unit. Patients with neurological disease or congenital heart disease we excluded from the study.","other_id":"5391/17","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  patients over 18 years\r\n\r\n          -  patients post-acute myocardial infarctium\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  patients with neurological disease\r\n\r\n          -  patients with congenital heart disease\r\n      ","sponsor":"Instituto de Cardiologia do Rio Grande do Sul","sponsor_type":"Other","conditions":"Acute Myocardial Infarction","interventions":[{"intervention_type":"Device","name":"Device: Heart monitor","description":"Use of heart monitor device in the patients after acute myocardium infarct."},{"intervention_type":"Device","name":"Device: No heart monitor","description":"Standard monitoring by nurses."}],"outcomes":[{"outcome_type":"primary","measure":"Heart rhythm monitoring","time_frame":"One year","description":"Evaluating the effectiveness of a heart monitoring device in the prevention and detection of events in patients after acute myocardial infarction"}]}
{"nct_id":"NCT04109339","start_date":"2019-05-01","phase":"N/A","enrollment":80,"brief_title":"Effects of Oxytocin on Hemodynamics in Patients Undergoing Laparoscopic Myomectomy","official_title":"Effects of Oxytocin on Hemodynamics in Patients Undergoing Laparoscopic Myomectomy","primary_completion_date":"2019-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2020-10-01","last_update":"2019-09-30","description":"This project will study the effect of oxytocin on hemodynamics in patients undergoing laparoscopic myomectomy, and how to prevent and manage such hemodynamic changes effectively.It provides a reference for the rational use of oxytocin in clinical practice, which can not only effectively contract the uterus and reduce bleeding, but also reduce the influence on hemodynamics.","other_id":"20190501","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Quadruple","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  General anesthesia for gynecological laparoscopic surgery,ASA I~III\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Oxytocin use contraindications\r\n      ","sponsor":"Yangzhou University","sponsor_type":"Other","conditions":"Oxytocin|Hemodynamic Monitoring|Laparoscopic Surgery","interventions":[{"intervention_type":"Drug","name":"Drug: Oxytocin","description":"During the laparoscopic hysteromyomectomia operation, different doses of oxytocin was used with different routs."}],"outcomes":[{"outcome_type":"primary","measure":"Changes of traditional hemodynamic parameters after oxytocin use during laparoscopic hysteromyomectomia.","time_frame":"\"before induction\", \"before incision\", \"before oxytocin intramuscular injection\", and \"20 sec, 40 sec, 60 sec, 80 sec, 100 sec, 120 sec, 140 sec, 160 sec,180 sec after oxytocin intramuscular injection\".","description":"Parameters including SBP, DBP, MAP (mmHg) were measured by a Mostcare hemodynamic monitor."},{"outcome_type":"primary","measure":"Changes of traditional hemodynamic parameters after oxytocin use during laparoscopic hysteromyomectomia.","time_frame":"\"before induction\", \"before incision\", \"before oxytocin intramuscular injection\", and \"20 sec, 40 sec, 60 sec, 80 sec, 100 sec, 120 sec, 140 sec, 160 sec,180 sec after oxytocin intramuscular injection\".","description":"HR (beats/min) was measured by a Mostcare hemodynamic monitor."},{"outcome_type":"primary","measure":"Changes of volume management parameters after oxytocin use during laparoscopic hysteromyomectomia.","time_frame":"\"before induction\", \"before incision\", \"before oxytocin intramuscular injection\", and \"20 sec, 40 sec, 60 sec, 80 sec, 100 sec, 120 sec, 140 sec, 160 sec,180 sec after oxytocin intramuscular injection\".","description":"SVV (%) was measured by a Mostcare hemodynamic monitor."},{"outcome_type":"primary","measure":"Changes of volume management parameters after oxytocin use during laparoscopic hysteromyomectomia.","time_frame":"\"before induction\", \"before incision\", \"before oxytocin intramuscular injection\", and \"20 sec, 40 sec, 60 sec, 80 sec, 100 sec, 120 sec, 140 sec, 160 sec,180 sec after oxytocin intramuscular injection\".","description":"SVRI (dynes-sec/cm-5) was measured by a Mostcare hemodynamic monitor."},{"outcome_type":"primary","measure":"Changes of volume management parameters after oxytocin use during laparoscopic hysteromyomectomia.","time_frame":"\"before induction\", \"before incision\", \"before oxytocin intramuscular injection\", and \"20 sec, 40 sec, 60 sec, 80 sec, 100 sec, 120 sec, 140 sec, 160 sec,180 sec after oxytocin intramuscular injection\".","description":"CI (l/min/m2) was measured by a Mostcare hemodynamic monitor."},{"outcome_type":"primary","measure":"Changes of volume management parameters after oxytocin use during laparoscopic hysteromyomectomia.","time_frame":"\"before induction\", \"before incision\", \"before oxytocin intramuscular injection\", and \"20 sec, 40 sec, 60 sec, 80 sec, 100 sec, 120 sec, 140 sec, 160 sec,180 sec after oxytocin intramuscular injection\".","description":"CO (l/min) was measured by a Mostcare hemodynamic monitor."}]}
{"nct_id":"NCT03900741","start_date":"2019-04-30","phase":"N/A","enrollment":36,"brief_title":"Guided Bone Regeneration of Peri-implant Defects Comparing Submerged Versus Non-submerged Healing","official_title":"Guided Bone Regeneration of Peri-implant Defects Comparing Submerged Versus Non-submerged Healing: a Randomized Controlled Clinical Trial","primary_completion_date":"2021-05-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2021-05-31","last_update":"2019-04-04","description":"Objective: the objective of the present randomized clinical trial is to compare changes in radiographic peri-implant bone defect fill after regeneration of peri-implant intrabony defects with a submerged versus a non-submerged protocol. Material and Methods: this project is a randomized controlled clinical trial, double blind, with a parallel groups design. Thirty-six patients presenting with peri-implantitis subsidiary of regenerative treatment will be recruited. After subjects have been given informed consent, they will be randomized to test or control group. All patients will undergo a session of non-surgical peri-implantitis therapy consisting on prostheses removal and implant debridement with ultrasounds, curettes and air-abrasive under local anaesthesia. Patients in test group will have their prostheses removed and the mucosa surrounding the affected implants will be let heal covering the implants, while patients in control group will have their prostheses installed again after the non-surgical therapy. Six to eight weeks later, all subjects will undergo regenerative treatment with the use of a bone substitute, a collagen membrane and fixation pins, and in control group tissues will heal following the non-submerged protocol, meanwhile subjects in test group will undergo submerged healing. Six months later, subjects in test group will have their prostheses reconnected to the regenerated implants. All patients will undergo periodontal and peri-implant maintenance therapy every three months during follow-up. Radiographic assessment of vertical bone level changes (primary outcome), clinical status of peri-implant tissues, changes in soft tissues margin, patient related outcomes and adverse events will be assessed at 3, 6 and 12 months after peri-implantitis regenerative surgery.","other_id":"18/575-R_X","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients diagnosed of peri-implantitis requiring surgical therapy\r\n\r\n          -  The periapical radiographic study demonstrates an intra-bony component greater than 3\r\n             mm at the affected implant\r\n\r\n          -  There is at least 2 mm of keratinized mucosa around the affected implant\r\n\r\n          -  Intrasurgically, peri-implant defects must be type Ia, Ib, Ic and Ie (according to\r\n             Schwarz et al. 2007)\r\n\r\n          -  Affected implants must be two-piece implants to allow for the submerged protocol\r\n\r\n          -  Affected implant supported restorations must be screw-retained or cemented, and should\r\n             allow for prostheses removal\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with untreated periodontitis\r\n\r\n          -  Medical conditions requiring prolonged use of steroids and/or medications that can\r\n             interfere with bone metabolism\r\n\r\n          -  Metabolic disorders such as osteoporosis\r\n\r\n          -  History of uncontrolled endocrine disorders\r\n\r\n          -  History of leukocyte dysfunction and deficiencies\r\n\r\n          -  History of immunodeficiency syndromes\r\n\r\n          -  History of neoplastic disease requiring the use of radiation of chemotherapy\r\n\r\n          -  History of renal failure\r\n\r\n          -  Physical handicaps that would interfere with the ability to perform adequate oral\r\n             hygiene\r\n\r\n          -  Alcoholism or drug abuse\r\n\r\n          -  Smokers of more than 10 cigarettes per day, cigar equivalents or tobacco chewers\r\n\r\n          -  Any other condition or circumstance that, in the opinion of the investigator, would\r\n             prevent completion of study participation or interfere with the analysis of the study\r\n             results, such as history of non-compliance or unreliability\r\n      ","sponsor":"Ana Molina Villar","sponsor_type":"Other","conditions":"Peri-Implantitis","interventions":[{"intervention_type":"Procedure","name":"Procedure: Submerged healing","description":"Bone regeneration of peri-implantitis defects using a bone xenograft and a resorbable collagen membrane, with flap suturing using a submerged healing protocol"},{"intervention_type":"Procedure","name":"Procedure: Non-submerged healing","description":"Bone regeneration of peri-implantitis defects using a bone xenograft and a resorbable collagen membrane, with flap suturing using a non-submerged healing protocol"}],"outcomes":[{"outcome_type":"primary","measure":"Changes in radiographic bone fill","time_frame":"Baseline, 3 months, 6 months and 12 months post-surgery","description":"Changes in radiographic bone fill measured from the implant shoulder to the first bone to implant contact with ImageJ software, in parallelized periapical x-rays with individual silicone bite blocks"},{"outcome_type":"secondary","measure":"Changes in pocket probing depth","time_frame":"At baseline, after non-surgical therapy, 6 months and 12 months post-surgery","description":"Depth of the peri-implant sulcus/pocket measured in millimeters with a 15-UNC (University of North Carolina) periodontal probe, at six sites per implant without the crown"},{"outcome_type":"secondary","measure":"Changes in bone probing depth","time_frame":"At baseline, after non-surgical therapy and 12 months post-surgery","description":"Distance from the mucosal margin to the peri-implant bone measured in millimeters with a 15-UNC (University of North Carolina) periodontal probe under local anesthesia, at six sites per implant without the crown"},{"outcome_type":"secondary","measure":"Changes in modified plaque index","time_frame":"At baseline, after non-surgical therapy, 6 months and 12 months post-surgery","description":"Presence or absence of plaque assessed at six sites per tooth/implant in the whole mouth, excluding third molars"},{"outcome_type":"secondary","measure":"Changes in full mouth bleeding scores","time_frame":"At baseline, after non-surgical therapy, 6 months and 12 months post-surgery","description":"Presence or absence of bleeding after probing with a 15-UNC (University of North Carolina) periodontal probe, assessed at six sites per tooth/implant in the whole mouth, excluding third molars. The presence of bleeding in each site will be scored 1, and the absence of bleeding will be scored 0. Full mouth bleeding score will be expressed in percentage and calculated as follows: number of sites bleeding / number of sites explored ^ 100"},{"outcome_type":"secondary","measure":"Soft tissue healing scores","time_frame":"1 week, 2 weeks and 4 weeks post-surgery","description":"Extent of soft tissue healing after surgery following Landry et al. Healing Index (1988):\r\nHealing index 1 - Very Poor\r\nHealing index 2 - Poor\r\nHealing index 3 - Good\r\nHealing index 4 - Very good\r\nHealing index 5 - Excellent"},{"outcome_type":"secondary","measure":"Pain assessment","time_frame":"1 week, 2 weeks and 4 weeks post-surgery","description":"Participants´ subjective pain assessed using a Visual Analogue Scale (VAS) with ratings from 0-10, whereof 0 = no pain and 10 = very intense."},{"outcome_type":"secondary","measure":"Oral Health Impact Profile (OHIP-14)","time_frame":"Baseline, 3 months, 6 months and 12 months post-surgery","description":"Self-reported dysfunction, discomfort and disability attributed to the participants´ oral condition"},{"outcome_type":"secondary","measure":"Adverse events´ occurrence","time_frame":"Up to 12 months post-surgery","description":"Occurrence of any untoward, undesired or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a subject participant in the clinical investigation. The event does not nee to be casually related to the cliinical investigation"}]}
{"nct_id":"NCT04224649","start_date":"2019-04-23","phase":"N/A","enrollment":67,"brief_title":"To Evaluate the Efficacy and Safety of Injection With HARA as Compared to Restylane Lidocaine in Temporary Correction of Nasolabial Folds","official_title":"A Single Center, Randomized, Subject & Evaluator-blind, Matched Pairs, Active-controlled Design Pivotal Study to Evaluate the Efficacy and Safety of Injection With HARA as Compared to Restylane Lidocaine in Temporary Correction of Nasolabial Folds","primary_completion_date":"2020-01-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2020-07-30","last_update":"2020-01-13","description":"- Investigational Device : HARA (Hyaluronic Acid Filler) - Title : A Single center, Randomized, Subject & Evaluator-blind, Matched pairs, Active-controlled design Pivotal study to Evaluate the Efficacy and Safety of Injection with HARA as Compared to Restylane Lidocaine in temporary Correction of Nasolabial folds - Sites and investigators : Chung-ang University Hospital(Seoul), Beom-Joon Kim, M.D, Ph.D - Objective : To compare the non-inferiority of HARA with Restylane Lidocaine for evaluation of the efficacy and safety on Nasolabial Folds","other_id":"HU-055","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":19,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Those who agreed to this treatment and signed the Informed Consent Form\r\n\r\n          2. Those who are 19 years old or more and desire to take correction of nasolabial folds\r\n\r\n          3. Those who have an intention of refraining from other cosmetic treatment(other filler\r\n             injection, laser or chemical peeling, Botox injection or wrinkle reduction) during the\r\n             clinical study period\r\n\r\n          4. Those whose Wrinkle Severity Rating Scale (WSRS) is more than 2 points at least\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Those who are sensitive to lidocaine or other amide anesthesia\r\n\r\n          2. Those who are sensitive to control device\r\n\r\n          3. Those who are pregnant or lactating, or expect pregnancy\r\n\r\n          4. Those who are judged by the subinvestigator to be improper for this study\r\n      ","sponsor":"Huons Co., Ltd.","sponsor_type":"Industry","conditions":"Nasolabial FOLD","interventions":[{"intervention_type":"Device","name":"Device: HARA Filler(Hyaluronic acid Filler)","description":"The same participants received the experimental device and the active comparator device at the same time (left and right sides of face)."},{"intervention_type":"Device","name":"Device: Restylane Lidocaine","description":"The same participants received the experimental device and the active comparator device at the same time (left and right sides of face)."}],"outcomes":[{"outcome_type":"primary","measure":"Assessment By independent evaluator","time_frame":"Week 24 From baseline Visit(=Investigational Device Injection)","description":"Wrinkle Severity Rating Scale (WSRS, Wrinkle severity Rating scale)\r\n* Grade 1: Absent, Grade 2: Mild, Grade 3: Moderate, Grade 4: Severe, Grade 5: Extereme"}]}
{"nct_id":"NCT03839329","start_date":"2019-04-17","phase":"N/A","enrollment":81,"brief_title":"Group Acceptance and Commitment Training (ACT) With Healthy Older Adults","official_title":"Well-being in ACTion: Examining the Impact of Acceptance and Commitment Training in Community-Dwelling Older Adults","primary_completion_date":"2020-09-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-09-01","last_update":"2020-11-13","description":"The current study aims to explore the impact of a two-session group Acceptance and Commitment Therapy (ACT) intervention compared to an assessment-only control on psychological outcomes in healthy older adults. The proposed study has two main objectives. 1. Examine the impact the intervention on targeted ACT processes over time 2. Examine the impact of the intervention on aspects of eudaimonic well-being over time","other_id":"201902715","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Participants will be randomized (stratified by sex) to either the ACT workshop group or to the assessment-only control group. Participants in the ACT group will complete two 90-minute group workshops (scheduled approximately one week apart) and will complete a baseline, 1-month, 3-month, and 6-month follow-up assessment. Participants in the time-matched assessment only-group will complete assessments at baseline, 1-month, 3-month, and 6-month follow-up.","sampling_method":"","gender":"All","minimum_age":65,"maximum_age":99,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  healthy, community-dwelling older adult (age 65-99)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  significant primary psychiatric disease\r\n\r\n          -  medications that have the potential to affect cognitive functioning\r\n\r\n          -  neurological events\r\n      ","sponsor":"Anne Roche, MA","sponsor_type":"Other","conditions":"Aging|Quality of Life","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Acceptance and Commitment Training","description":"Acceptance and Commitment Therapy is an acceptance- and mindfulness-based psychotherapy that aims to foster psychological flexibility."}],"outcomes":[{"outcome_type":"secondary","measure":"Differences in change over time between conditions on the Ryff's Scales of Psychological Well-Being 14-item Personal Growth Scale","time_frame":"baseline, 1-month, 3-month, and 6-month post-intervention follow-up","description":"Ryff's Scales of Psychological Well-Being 14-item Personal Growth Scale is a self-report measure. Total scores range from 14-84, with higher scores indicative of greater personal growth."},{"outcome_type":"primary","measure":"Differences in change over time between conditions on The Comprehensive Assessment of Acceptance and Commitment Therapy processes (CompACT)","time_frame":"baseline, 1-month, 3-month, and 6-month post-intervention follow-up","description":"The CompACT is a self-report measure of psychological flexibility. Total scores on the measure range from 0-138 with higher scores indicative of greater psychological flexibility."},{"outcome_type":"secondary","measure":"Differences in change over time between conditions on the Patient-Reported Outcomes Measurement Information System's (PROMIS) 8-item Satisfaction with Social Roles and Activities scale","time_frame":"baseline, 1-month, 3-month, and 6-month post-intervention follow-up","description":"The PROMIS 8-item Satisfaction with Social Roles and Activities scale is a self-report measure. Total scores on the measure are converted to T scores."},{"outcome_type":"secondary","measure":"Differences in change over time between conditions on the Ryff's Scales of Psychological Well-Being 14-item Purpose in Life Scale","time_frame":"baseline, 1-month, 3-month, and 6-month post-intervention follow-up","description":"Ryff's Scales of Psychological Well-Being 14-item Purpose in Life Scale is a self-report measure. Total scores range from 14-84, with higher scores indicative of greater purpose in life."}]}
{"nct_id":"NCT03910387","start_date":"2019-04-17","phase":"Phase 2","enrollment":80,"brief_title":"Telotristat Ethyl to Promote Weight Stability in Patients With Advanced Stage Pancreatic Cancer","official_title":"Weight Loss in Patients With Advanced Stage Pancreatic Cancer: Role of Serotonin and Effects of Telotristat Ethyl","primary_completion_date":"2021-10-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-10-01","last_update":"2021-04-29","description":"This phase II trial studies how well telotristat ethyl works in promoting weight stability in patients with pancreatic adenocarcinoma that has come back and spread to other places in the body. Telotristat ethyl may decrease bowel movements which may make patients gain weight. Stabilizing weight may help patients tolerate chemotherapy better and improve longevity.","other_id":"IRB00105292","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  GROUP 1 (Telotristat ethyl treatment group): Written informed consent and Health\r\n             Insurance Portability and Accountability Act (HIPAA) authorization for release of\r\n             personal health information. NOTE: HIPAA authorization may be included in the informed\r\n             consent or obtained separately.\r\n\r\n          -  GROUP 1 (Telotristat ethyl treatment group): Weight loss of 10% or more.\r\n\r\n          -  GROUP 1 (Telotristat ethyl treatment group): Eastern Cooperative Oncology Group (ECOG)\r\n             Performance Status of 0-2 within 14 days prior to registration.\r\n\r\n          -  GROUP 1 (Telotristat ethyl treatment group): Histologic or cytological diagnosis of\r\n             recurrent or metastatic pancreas adenocarcinoma (PDAC) who present for first line\r\n             chemotherapy treatment for metastatic disease.\r\n\r\n          -  GROUP 1 (Telotristat ethyl treatment group): Advanced stage pancreas cancer\r\n             (recurrent/metastatic).\r\n\r\n          -  GROUP 1 (Telotristat ethyl treatment group): Measurable disease determined using\r\n             guidelines of Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Baseline\r\n             tumor assessment should be performed using high resolution computed tomography (CT)\r\n             scans or magnetic resonance imaging (MRI).\r\n\r\n          -  GROUP 1 (Telotristat ethyl treatment group): Prior systemic therapy (adjuvant or\r\n             neoadjuvant setting are acceptable) if disease progressed or recurred within at least\r\n             3 months after treatment.\r\n\r\n          -  GROUP 1 (Telotristat ethyl treatment group): Estimated life expectancy of > 12 weeks,\r\n             as assessed by the site investigator.\r\n\r\n          -  GROUP 1 (Telotristat ethyl treatment group): If sexually active, must be\r\n             postmenopausal, surgically sterile, or using effective contraception (hormonal or\r\n             barrier methods) due to unknown risk of teratogenicity.\r\n\r\n          -  GROUP 1 (Telotristat ethyl treatment group): Hemoglobin  8 g/dL (obtained within 7\r\n             days prior to registration).\r\n\r\n          -  GROUP 1 (Telotristat ethyl treatment group): Absolute Neutrophil Count (ANC) \r\n             1,500/mm (obtained within 7 days prior to registration).\r\n\r\n          -  GROUP 1 (Telotristat ethyl treatment group): Platelet Count (PLT)  100,000/mm\r\n             (obtained within 7 days prior to registration).\r\n\r\n          -  GROUP 1 (Telotristat ethyl treatment group): Creatinine  1.5 mg/dL (obtained within 7\r\n             days prior to registration).\r\n\r\n          -  GROUP 1 (Telotristat ethyl treatment group): Albumin  2 g/dL (obtained within 7 days\r\n             prior to registration).\r\n\r\n          -  GROUP 1 (Telotristat ethyl treatment group): Bilirubin  1.5 mg/dL (obtained within 7\r\n             days prior to registration).\r\n\r\n          -  GROUP 1 (Telotristat ethyl treatment group): Aspartate aminotransferase (AST)  3 x\r\n             upper limit of normal (ULN) or < 5 x ULN in the setting of liver metastases (obtained\r\n             within 7 days prior to registration).\r\n\r\n          -  GROUP 1 (Telotristat ethyl treatment group): Alanine aminotransferase (ALT)  3 x ULN\r\n             or < 5 x ULN in the setting of liver metastases (obtained within 7 days prior to\r\n             registration).\r\n\r\n          -  GROUP 1 (Telotristat ethyl treatment group): Prior radiation is allowed if happened\r\n             more than 2 weeks of enrollment.\r\n\r\n          -  GROUP 2 (Non-Telotristat ethyl group): Written informed consent and HIPAA\r\n             authorization for release of personal health information. NOTE: HIPAA authorization\r\n             may be included in the informed consent or obtained separately.\r\n\r\n          -  GROUP 2 (Non-Telotristat ethyl group): Stable weight or loss of < 10% by history.\r\n\r\n          -  GROUP 2 (Non-Telotristat ethyl group): ECOG Performance Status of 0-2 within 14 days\r\n             prior to registration.\r\n\r\n          -  GROUP 2 (Non-Telotristat ethyl group): Histologic or cytological diagnosis of locally\r\n             advanced unresectable, recurrent/metastatic PDAC who present for first line\r\n             chemotherapy treatment for metastatic disease.\r\n\r\n          -  GROUP 2 (Non-Telotristat ethyl group): Advanced stage PDAC (locally advanced\r\n             unresectable/recurrent/metastatic).\r\n\r\n          -  GROUP 2 (Non-Telotristat ethyl group): Prior systemic therapy (adjuvant or neoadjuvant\r\n             setting are acceptable) if disease progressed or recurred within at least 3 months\r\n             after treatment.\r\n\r\n          -  GROUP 2 (Non-Telotristat ethyl group): Estimated life expectancy of > 12 weeks, as\r\n             assessed by the site investigator.\r\n\r\n          -  GROUP 2 (Non-Telotristat ethyl group): Prior radiation is allowed if happened more\r\n             than 2 weeks of enrollment.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  GROUP 1 (Telotristat ethyl treatment group): Subjects with histology other than\r\n             adenocarcinoma. Examples include: neuroendocrine tumors, acinar cell cancer, sarcoma\r\n             or lymphoma of the pancreas.\r\n\r\n          -  GROUP 1 (Telotristat ethyl treatment group): Ongoing or active infection.\r\n\r\n          -  GROUP 1 (Telotristat ethyl treatment group): Symptomatic congestive heart failure,\r\n             unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia.\r\n             Symptomatic heart failure (New York Heart Association [NYHA] Class II-IV).\r\n\r\n          -  GROUP 1 (Telotristat ethyl treatment group): Acute or sub-acute intestinal\r\n             obstruction.\r\n\r\n          -  GROUP 1 (Telotristat ethyl treatment group): Ascites.\r\n\r\n          -  GROUP 1 (Telotristat ethyl treatment group): Documented and/or symptomatic or known\r\n             brain or leptomeningeal metastases.\r\n\r\n          -  GROUP 1 (Telotristat ethyl treatment group): Severely immune-compromised (other than\r\n             being on steroids) including known human immunodeficiency virus (HIV) infection.\r\n\r\n          -  GROUP 1 (Telotristat ethyl treatment group): Concurrent active malignancy, other than\r\n             adequately treated non-melanoma skin cancer, other noninvasive carcinoma, or in situ\r\n             neoplasm. A subject with previous history of malignancy is eligible if he/she has been\r\n             disease-free for > 3 years.\r\n\r\n          -  GROUP 1 (Telotristat ethyl treatment group): Breast-feeding or pregnant. Serum\r\n             pregnancy test for women of child-bearing potential must be performed within 7 days\r\n             prior to first dose of study treatment.\r\n\r\n          -  GROUP 1 (Telotristat ethyl treatment group): Prior autologous or allogeneic organ or\r\n             tissue transplantation.\r\n\r\n          -  GROUP 1 (Telotristat ethyl treatment group): Known allergy to any of the treatment\r\n             components.\r\n\r\n          -  GROUP 1 (Telotristat ethyl treatment group): Have any condition that does not permit\r\n             compliance with the study schedule including psychological, geographical, or medical.\r\n\r\n          -  GROUP 1 (Telotristat ethyl treatment group): Not able to swallow. Inability to take\r\n             oral medications.\r\n\r\n          -  GROUP 1 (Telotristat ethyl treatment group): Patients with chronic constipation.\r\n\r\n          -  GROUP 2 (Non-Telotristat ethyl group): Subjects with histology other than\r\n             adenocarcinoma. Examples include: neuroendocrine tumors, acinar cell cancer, sarcoma\r\n             or lymphoma of the pancreas.\r\n\r\n          -  GROUP 2 (Non-Telotristat ethyl group): Ongoing or active infection.\r\n\r\n          -  GROUP 2 (Non-Telotristat ethyl group): Symptomatic congestive heart failure, unstable\r\n             angina or arrhythmia. Symptomatic heart failure (NYHA Class II-IV).\r\n\r\n          -  GROUP 2 (Non-Telotristat ethyl group): Acute or sub-acute intestinal obstruction.\r\n\r\n          -  GROUP 2 (Non-Telotristat ethyl group): Severely immune-compromised (other than being\r\n             on steroids) including known HIV infection.\r\n      ","sponsor":"Emory University","sponsor_type":"Other","conditions":"Locally Advanced Unresectable Pancreatic Adenocarcinoma|Metastatic Pancreatic Adenocarcinoma|Recurrent Pancreatic Adenocarcinoma|Stage III Pancreatic Cancer AJCC v8|Stage IV Pancreatic Cancer AJCC v8","interventions":[{"intervention_type":"Drug","name":"Drug: Gemcitabine","description":"Given gemcitabine/nab-paclitaxel combination therapy"},{"intervention_type":"Drug","name":"Drug: Nab-paclitaxel","description":"Given gemcitabine/nab-paclitaxel combination therapy"},{"intervention_type":"Drug","name":"Drug: Telotristat Ethyl","description":"Given PO"}],"outcomes":[{"outcome_type":"primary","measure":"Weight stability","time_frame":"Baseline up to 3 months after study start","description":"Weight stability will be documented as percent weight change at 3 months compared to baseline."},{"outcome_type":"secondary","measure":"Change in serum 5-hydroxyindoleacetic acid (5-HIAA) levels","time_frame":"Baseline up to 4 months after study start","description":"The change will be summarized as mean and standard deviation."},{"outcome_type":"secondary","measure":"Change in 24-hr urine 5-hydroxyindoleacetic acid (5-HIAA) levels","time_frame":"Baseline up to 4 months after study start","description":"The change will be summarized as mean and standard deviation."},{"outcome_type":"secondary","measure":"Mid arm circumference (MAC) measured in inches","time_frame":"Up to 2 years after study start","description":"Mid arm circumference (MAC) will be reviewed on cross sectional imaging and will be assessed with imaging guided measurements of the psoas and rectus abdominis muscle."},{"outcome_type":"secondary","measure":"Quality of life (QOL)","time_frame":"Up to 2 years after study start","description":"Quality of life (QOL) will be assessed by the Obesity Related Quality of Life (OWL-QOL)-17 questionnaire."},{"outcome_type":"secondary","measure":"Blood serotonin levels","time_frame":"Up to 2 years after study start","description":"Blood serotonin levels will be compared in the 2 groups."},{"outcome_type":"secondary","measure":"Response rate (RR)","time_frame":"Up to 2 years after study start","description":"Response rate (RR) will be assessed per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, in patients receiving telotristat ethyl (Group 1)."},{"outcome_type":"secondary","measure":"Median overall survival (MOS)","time_frame":"Up to 2 years after study start","description":"Median overall survival (MOS) will be measured using the Kaplan-Meier method."},{"outcome_type":"secondary","measure":"Duration of response","time_frame":"Up to 2 years after study start","description":"Duration of response will be estimated from time of documentation of response to time of progression and will be evaluated by computed tomography/magnetic resonance imaging scans of the organ(s) with the target lesion(s) based on RECIST criteria."}]}
{"nct_id":"NCT03926286","start_date":"2019-04-15","phase":"Phase 1","enrollment":10,"brief_title":"Fecal Microbial Transplant (FMT) for Sjogrens Syndrome","official_title":"Fecal Microbial Transplant for Sjogrens Syndrome","primary_completion_date":"2020-06-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-06-01","last_update":"2020-06-05","description":"This is an open label study to evaluate the effect of Fecal Microbiota Transplantation (FMT) on the gut microbiome and Systemic parameters.","other_id":"20170733","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion criteria:\r\n\r\n          1. Positive diagnosis of Sjogrens syndrome, defined by meeting two or more of the\r\n             following three criteria:\r\n\r\n               -  Positive serum anti-SS-A/Ro and/or anti-SS-B/La (or positive rheumatoid factor\r\n                  and ANA  1:320)\r\n\r\n               -  Labial salivary gland biopsy exhibiting focal lymphocytic sialadenitis with a\r\n                  focus score  focus/4 mm2\r\n\r\n               -  Keratoconjunctivitis sicca with ocular staining score  3 (assuming that\r\n                  individual is not currently using daily eye drops for glaucoma, and has not had\r\n                  corneal surgery or cosmetic eyelid surgery in the last 5 years)\r\n\r\n             Or by both of the following:\r\n\r\n             Positive antibodies to one of the early markers of Sjogrens Syndrome:\r\n\r\n               -  Anti-salivary gland protein 1 (SP1)\r\n\r\n               -  Anti-carbonic anhydrase 6 (CA6)\r\n\r\n               -  Parotid secretory protein (PSP) Ocular staining score  3\r\n\r\n          2. Age  18 years at time of enrollment\r\n\r\n          3. Able to provide signed and dated informed consent\r\n\r\n          4. Women of child childbearing potential in sexual relationships with men must use an\r\n             acceptable method of contraception from 30 days prior to enrollment until 4 weeks\r\n             after completing study treatment.\r\n\r\n          5. Males must agree to avoid impregnation of women during and for four weeks after\r\n             completing study treatment through use of an acceptable method of contraception*.\r\n\r\n               -  Includes, but is not limited to, barrier with additional spermicidal foam or\r\n                  jelly, intrauterine device, hormonal contraception (started at least 30 days\r\n                  prior to study enrollment), intercourse with men who underwent vasectomy.\r\n\r\n                    -  Includes, but is not limited to, barrier with additional spermicidal foam or\r\n                       jelly and vasectomy.\r\n\r\n        Participant exclusion criteria\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Inability to provide informed consent and/or unable or unwilling to comply with\r\n             protocol requirements.\r\n\r\n          2. Antibiotics for at least 2 weeks prior to FMT.\r\n\r\n          3. Active infection for >15 days: bacteremia, urinary tract infection, pneumonia or\r\n             abdominal collection.\r\n\r\n          4. Known or suspected toxic megacolon and/or known small bowel ileus.\r\n\r\n          5. Previous FMT\r\n\r\n          6. Major gastrointestinal surgery (e.g. significant bowel resection) within 3 months\r\n             before enrollment. This does not include appendectomy or cholecystectomy.\r\n\r\n          7. History of total colectomy or bariatric surgery.\r\n\r\n          8. Antibiotics for the treatment of an active infection or anticipated antibiotic use\r\n             during trial duration.\r\n\r\n          9. Concurrent intensive induction chemotherapy, radiation therapy or biological treatment\r\n             for active malignancy.\r\n\r\n         10. Expected life expectancy < 6 months\r\n\r\n         11. Patients with a history of severe anaphylactic or anaphylactoid food allergy.\r\n\r\n         12. Solid organ transplant patients  90 days post-transplant or on active treatment for\r\n             rejection.\r\n\r\n         13. Neutropenia (<500 neutrophils/mL) or other severe immunosuppression. Patients on\r\n             monoclonal antibodies to B and T cells, anti-tumor necrosis factor, glucocorticoids,\r\n             antimetabolites, calcineurin inhibitors may be enrolled after consultation with their\r\n             medical doctor.\r\n\r\n         14. Renal failure (GFR <30 or dialysis)\r\n\r\n         15. Human immunodeficiency virus+ controlled or not well controlled on antiretroviral\r\n             therapy\r\n\r\n         16. Regular probiotic supplement use within prior 2 weeks to enrollment\r\n\r\n         17. Pregnancy or inability/unwillingness to use contraceptives.\r\n\r\n         18. A condition that would jeopardize the safety or rights of the subject, would make it\r\n             unlikely for the subject to complete the study, or would confound the results of the\r\n             study.\r\n\r\n         19. Exclusion on the discretion of the PI.\r\n      ","sponsor":"University of Miami","sponsor_type":"Other","conditions":"Sjogren's Syndrome","interventions":[{"intervention_type":"Drug","name":"Drug: FMP-30","description":"FMP-30 containing frozen human fecal microbiota administered as (3) units of FMP30 enema on Day 0 and Week1"}],"outcomes":[{"outcome_type":"primary","measure":"Number of participants with reported adverse events (AEs) and serious adverse events (SAEs)","time_frame":"7 months","description":"As an evaluation of the safety of FMT, the number of participants with reported AEs and SAEs will be collected. All occurrences of AEs and SAEs, regardless of relatedness to FMT, will be reported and assessed by the clinician using the NIH CTCAE."},{"outcome_type":"primary","measure":"Number of participants with stable microbiome engraftment","time_frame":"month 3","description":"Engraftment will be analyzed via the Jensen-Shannon divergence (JSD). The engraftment scores will be the ratio between the donors and recipients at the bacterial genus level. Participants who successfully engraft will more closely resemble the donor microbial profile on JSD analysis."},{"outcome_type":"secondary","measure":"Change in dry eye symptoms","time_frame":"baseline, 1 week, 1 month, 3 months","description":"Dry eye symptoms will be measured by the Ocular Surface Disease Index (OSDI) Scale 0-100 Continuous with higher scores representing greater dry eye symptoms"},{"outcome_type":"secondary","measure":"Change in dry eye symptoms","time_frame":"baseline, 1 week, 1 month, 3 months","description":"Dry eye symptoms will be measured by the Dry Eye Questionnaire 5 (DEQ5) Scale Range 0-22 Continuous with a higher number representing greater symptomatology of dry eye"},{"outcome_type":"secondary","measure":"Change in diversity of bacterial communities","time_frame":"Pre FMT, 3 months post FMT","description":"This will be captured via high-throughput 16S gene sequencing using DNA extracted from stool specimens in study participants. The Shannon diversity index will be used as our primary measure of diversity."},{"outcome_type":"secondary","measure":"Change in system immune profiles as measured by T cell populations","time_frame":"Pre-FMT, 1 Week, 1 Month, 3 months post FMT","description":"System immune profiles will be evaluated by completing a comprehensive immuno-phenotypic profile from blood samples evaluating T cell populations including Th1, Th17, and T regulatory cells."},{"outcome_type":"secondary","measure":"Change in ocular and systemic symptoms as measured by the quality of life SF-12 Questionnaire","time_frame":"Pre-FMT, 1 Week, 1 Month, 3 months post FMT","description":"Ranges 0-100 with higher scores representing a better quality of life"},{"outcome_type":"secondary","measure":"Change in self-reported ocular pain as assessed by the Numerical Rating Scale(NRS)","time_frame":"Pre-FMT, 1 Week, 1 Month, 3 months post FMT","description":"NRS Scoring Ranges from 0-10 with 0=no pain sensation and 10=the most intense eye pain imaginable"},{"outcome_type":"secondary","measure":"Change in self-reported ocular pain as assessed by the Short-form McGill Pain Questionnaire(SFM-PQ)","time_frame":"Pre-FMT, 1 Week, 1 Month, 3 months post FMT","description":"SFM-PQ Scoring Ranges from 0-45 with zero to 45 with a higher score indicating more server eye pain"},{"outcome_type":"secondary","measure":"Change in self-reported ocular pain as assessed by the Neuropathic Pain Symptom Inventory (NPSI)","time_frame":"Pre-FMT, 1 Week, 1 Month, 3 months post FMT","description":"NPSI Scoring Ranges from 0-100 with the higher score indicating the worse pain imaginable."},{"outcome_type":"secondary","measure":"Depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)","time_frame":"Pre-FMT, 1 Week, 1 Month, 3 months post FMT","description":"PHQ-9 scoring Ranges from 0-27 with the higher score indicating a greater degree of depression"},{"outcome_type":"secondary","measure":"Depression as assessed by the Symptom Checklist 90 for Depression (SCL-90 Depression)","time_frame":"Pre-FMT, 1 Week, 1 Month, 3 months post FMT","description":"SCL-90 Depression scoring ranges from 0-4 with the higher score indicating a greater degree of depression."},{"outcome_type":"secondary","measure":"Anxiety as assessed by the Symptom Checklist 90 for Anxiety (SCL-90 Anxiety)","time_frame":"Pre-FMT, 1 Week, 1 Month, 3 months post FMT","description":"SCL-90 Anxiety scoring ranges from 0-4 with the higher score indicating a greater degree of anxiety."}]}
{"nct_id":"NCT04180241","start_date":"2019-04-15","phase":"N/A","enrollment":50,"brief_title":"Development of Endoscopic Treatment for Achalasia","official_title":"Development of Endoscopic Treatment for Achalasia, POEM (Per Oral Esophageal Myotomy): A Randomized Controlled Trial","primary_completion_date":"2027-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2027-12-31","last_update":"2021-02-04","description":"Per Oral Endoscopic Myotomy (POEM); comparison of two surgical techniques division all the esophageal muscle layers versus division the inner circular muscle layer of the esophagus only.","other_id":"2017/1630-31","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","intervention_model_description":"POEM with division all the esophageal muscle layers compared to deviding only the inner circular muscle layer of the esophagus.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Newly diagnosed achalasia\r\n\r\n          -  the patient should understand the nature and the purpose of the study and give\r\n             informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  previous surgical treatment of achalasia\r\n\r\n          -  inability to understand the contents of or follow the protocol\r\n\r\n          -  other pathology as an explanation for the obstruction of the esophageal transition\r\n      ","sponsor":"Karolinska Institutet","sponsor_type":"Other","conditions":"Achalasia","interventions":[{"intervention_type":"Procedure","name":"Procedure: POEM","description":"Peroral endoscopic myotomy"}],"outcomes":[{"outcome_type":"primary","measure":"The proportion of patients who develop gastroesophageal reflux disease (GERD)","time_frame":"1 year","description":"Measured as esophageal acid exposure (pH <4) > 4% of recorded time"},{"outcome_type":"secondary","measure":"Esophageal emptying function","time_frame":"1 year","description":"Measured by Time Barium Swallow X-ray"},{"outcome_type":"secondary","measure":"Eckardt score","time_frame":"1 year","description":"The Eckardt score consists of 4 components including dysphagia, chest pain, regurgitation, and weight loss.Each component is assigned a score from 0 to 3 based on the patient's self-reported response, resulting in a total score that can vary from 0 to 12, higher scores mean a worse outcome."},{"outcome_type":"secondary","measure":"RAND-36","time_frame":"1 year","description":"The RAND-36 It is comprised of 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions. Physical and mental health summary scores are also derived from the eight RAND-36 scales. higher scores mean a better outcome."},{"outcome_type":"secondary","measure":"Dysmotility","time_frame":"1 year","description":"measured by Manometry"},{"outcome_type":"secondary","measure":"Gastrointestinal Symptom Rating Scale (GSRS)","time_frame":"1 year","description":"Scoring;The questionnaire, which contains 15 items, uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one.\r\nA mean value for the items in each dimension should be calculated:\r\nDiarrhoea syndrome: 11. Increased passage of stools 12. Loose stools 14. Urgent need for defecation Indigestion syndrome: 6. Borborygmus 7. Abdominal distension 8. Eructation 9. Increased flatus Constipation syndrome: 10. Decreased passage of stools 13. Hard stools 15. Feeling of incomplete evacuation Abdominal pain syndrome: 1. Abdominal pain 4. Sucking sensations 5. Nausea and vomiting Reflux syndrome: 2. Heartburn 3. Acid regurgitation"}]}
{"nct_id":"NCT04376463","start_date":"2019-04-13","phase":"N/A","enrollment":50,"brief_title":"Effects of a Multicomponent Exercise and Supplementation of BCAAs in Immunity System Dwelling Elderly","official_title":"Effects of a Multicomponent Exercise and Supplementation of Branched Chain Aminoacids Health Parameters in the Dwelling Elderly","primary_completion_date":"2019-09-14","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2020-12-15","last_update":"2020-05-06","description":"The frailty syndrome (FS) is characterized by a multifactorial clinical syndrome, which includes 5 items, 1 - Change in body composition, 2 - Holding force, 3 - Fatigue reported, 4 - Reduction of walking speed, 5 - Low physical activity. The cumulative effect of deficits on the physiological functions caused by the syndrome results in early physical and cognitive loss. It is known that physical exercise, associated with protein supplementation are examples of non-pharmacological treatments that can promote functional and structural adaptive responses of the skeletal muscle system. One of the factors related to frailty is the reduction of body and muscle mass. Branched-chain amino acids, especially leucine, are nutrients that influence the adaptative response of muscle. It is intended through a physical exercise program (multicomponent = exercise of strength + aerobic exercise), to attenuate the effects of ageing and mainly of physical and cognitive frailty, evaluating the health parameters of frail elderly, alone or together with supplementation (BCAA), branched-chain amino acids, modulation of immune markers, markers of malnutrition and the skeletal muscle system in frail and pre-frail dwelling elderly people living in the city of Coimbra. To achieve that, the following parameters will be evaluated: biosocial indicators, anthropometric evaluation and body composition, indicators of global health and functional physical fitness, inflammatory biomarkers, neuroendocrine, signs of skeletal muscle function, evaluation of quality of life related to emotional state, cognitive profile and frailty-trait evaluation. The results obtained from the indicators, markers and questionnaires used are expected to contribute to the attenuation of frailty, improving the health and quality of life of the elderly. Keywords: frail elderly, multicomponent exercise, branched chain amino acid, healthy life","other_id":"UC","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"Single","intervention_model_description":"It was an experimental design, controlled, non-randomized, with a convenience sample of 16-week supplementation combined or not with exercise. All participants in the groups ME+BCAA and BCAA received at the beginning of the protocol a bottle with assigned codes with flavourless powder (BCAA), and a dosage of 0.21g/kg/session. They took the supplement with 200 ml of water immediate after exercise, in the ME+BCAA group, and at the same time in the BCAA group (Ispoglou et al., 2016). Throughout the intervention period, all tests and intervention were done after breakfast and before lunch (supplementation, physical exercise, data collection, questionnaires, physical tests), and 30-60 minutes before lunch. The ME group just folowed the exercice protocol, and CGne group did not alter their usual routine.","sampling_method":"","gender":"All","minimum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Fried criteria\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Dementia\r\n\r\n          -  Morbid obesity, and the use of medications that may cause great attention impairment.\r\n      ","sponsor":"University of Coimbra","sponsor_type":"Other","conditions":"Frail Elderly Syndrome|Physical Exercise","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Branched Chain Aminoacid","description":"It is an experimental design, controlled with 8 months of supplementation combined with exercise and washout 2 months, totalling 10 month intervention."}],"outcomes":[{"outcome_type":"primary","measure":"THE INDEPENDENT AND COMBINED EFFECTS OF A 16-WEEK EXERCISE AND BCAA SUPPLEMENTATION ON FRAILTY MARKERS AND MOOD STATES OF OLDER WOMEN","time_frame":"up to 24 weeks","description":"Physical function and muscle strength Short physical performance battery (SPPB) was used to assess gait speed, chair stand, and balance tests. This SPPB test is composed of 3 subdimensions: i) static balance (composed of 3 tests), ii) muscular strength of the lower limb, which consist of get up and seat in a chair, 5 times, with arms crossed at the chest, and iii) 3-meter test, that marks the time to travels the 3-meter course, in the usual speed (Guralnik et al., 1994)."},{"outcome_type":"primary","measure":"Geriatric Depression Scale","time_frame":"up to 24 weeks","description":"The GDS-15, (Yesavage, 1982) consisting of 15 direct questions with yes or no answers, which evaluate e classify the psychological condition related to depression and its symptoms. The score result has 3 response modes 0 to 5 points indicates normal psychological condition, (no symptoms of depression), 6 to 10 points indicates (mild depressive symptoms), 11 to 15 indicates (symptoms of serious depression). The scale GDS was translate in Portuguese by (Apóstolo, 2014)."},{"outcome_type":"secondary","measure":"Profile of Mood State short version (POMS-sv)","time_frame":"through study completion, an average of 1 year","description":"Profile of Mood State (McNair, 1971) is a test to evaluated individual's mood state. This tool, self-related and easy to use, is able to verify a transient profile. A short version (Raglin & Morgan, 1989) was applied to facilitate use. POMS consist of 22 Likert-type question, divided in six dimensions with scales from 0 to 4. The final score consists of a sum of all negative dimensions subtracting the positive dimension of Vigour. Total Mood Disturbance (TMD) scores of Profile of Mood States (T+D+H+F+C)-V), (Tension-anxiety, depression-melancholia, Hostility-anger, Fatigue-inertia, Confusion, and Vigour), (Viana, Almeida, & Santos, 2001)."},{"outcome_type":"secondary","measure":"Mini Nutritional Assessment","time_frame":"through study completion, an average of 1 year questionnaire of nutrition","description":"Mini Nutritional Assessment The Mini Nutritional Assessment is calculated with a maximum total score of 30 points, in which the result of 17 points and below is characterized as malnourished, between 17 to 23.5 points, indicates a risk of malnutrition, and a score above 23.5 is normal nutritional status. A normal nutritional status was used to evaluate the nutritional status and the participants were classified as: Total points in the MNA® evaluation section (maximum 16 points). The results found will be sent to a nutritionist, (Loureiro, 2008). All participants were provided with similar diets, in terms of caloric intake and nutrients, controlled by a local nutritionist during the intervention period."},{"outcome_type":"secondary","measure":"The Charlson Comorbidity Index","time_frame":"through study completion, an average of 1 year (questionnaire) physiological parameter","description":"The Charlson comorbidity index was used to classify comorbid conditions based on the registry of each individual comorbidity and was combined with age and gender to form a single index (Charlson et al., 1987)."}]}
{"nct_id":"NCT03935438","start_date":"2019-04-12","phase":"N/A","enrollment":200,"brief_title":"The Influence of Cardiac Rehabilitation on the Health State After ACS","official_title":"The Influence of Cardiac Rehabilitation on the Health State of Patients After Acute Coronary Syndrome","primary_completion_date":"2024-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2024-12-31","last_update":"2020-04-29","description":"Coronary heart disease, including acute coronary syndromes (ACS), is the leading cause of death in European countries. One of the basic elements of secondary and tertiary prevention of ACS is cardiac rehabilitation. The aims of the study are evaluation of the impact of cardiac rehabilitation on health state- especially on cardiovascular function parameters in patients after acute coronary syndrome and evaluation of the influence of the level of gene expression and polymorphisms of genes associated with ischemic heart disease on the course of cardiac rehabilitation in patients after ACS. The study will consist of a retrospective and prospective part. The retrospective part will include patients who have had acute coronary syndrome in the past and then - before being included in the study - have undergone cardiac rehabilitation. In the retrospective part, patients enrolled in the study will not undergo cardiac rehabilitation as a part of the study intervention. The prospective part will include patients who have had an acute coronary syndrome in the past and will undergo cardiac rehabilitation as the study intervention. After being included in the study, patients will undergo medical examination. Then subsequent procedures will be performed: anthropometric measurements; ECG; body composition analysis by bioimpedance; measurement of resting blood pressure, resting heart rate and oxygen saturation of hemoglobin; pulse wave analysis; transthoracic echocardiography of the heart; 24-hour blood pressure measurement by ambulatory blood pressure monitoring (ABPM); 24-hour ECG recording using the Holter method; electrocardiographic exercise test on a treadmill and / or a six-minute walk test or other exercise test adequate to the patient's state of health; assessment of the quality of the diet; assessment of lifestyle, acceptance of disease and quality of life; assessment of the psychological profile. Subsequently patients taking part in the prospective part of the study will perform a cardiac rehabilitation program. After the cardiac rehabilitation program measurement procedures listed above will be repeated. Before and after the cardiac rehabilitation program blood samples, urine samples and hair samples will be collected. Blood samples, urine samples and hair samples will also be collected from patients taking part in the retrospective part of the study.","other_id":"476/19","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":99,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Informed consent in writing\r\n\r\n          -  Coronary heart disease, a state after an acute coronary syndrome\r\n\r\n          -  Female or male\r\n\r\n          -  Age 18 - 99 years\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Active neoplastic disease\r\n\r\n          -  Alcohol abuse, drug abuse\r\n\r\n          -  Pregnancy, lactation\r\n\r\n          -  Other conditions that in the opinion of researchers may pose any risk to the patient\r\n             during the study.\r\n      ","sponsor":"Poznan University of Medical Sciences","sponsor_type":"Other","conditions":"Cardiac Rehabilitation|Acute Coronary Syndrome","interventions":[{"intervention_type":"Other","name":"Other: Cardiac rehabilitation","description":"The training program of cardiac rehabilitation, depending on the results of the patient's medical qualification, will consist of the following: free active exercises, isometric exercises, active exercises in relief with resistance, isotonic exercises, isokinetic exercises, active breathing exercises, active breathing exercises with resistance, balance exercises, general exercises- individual and in groups, interval training on a treadmill or cycling cycloergometer, continuous training on a treadmill or cycling cycloergometer, circuit training, walking training, march training with accessories, autogenic training, walking. The training program will last an average 2 weeks."}],"outcomes":[{"outcome_type":"secondary","measure":"GGTP II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Blood concentration of gamma-glutamyltransferase II"},{"outcome_type":"secondary","measure":"total cholesterol (TCH) I","time_frame":"At baseline","description":"Blood concentration of total cholesterol I"},{"outcome_type":"secondary","measure":"alanine aminotransferase (ALT) I","time_frame":"At baseline","description":"Blood concentration of alanine aminotransferase I"},{"outcome_type":"primary","measure":"Pulse wave velocity (PWV) I","time_frame":"At baseline","description":"Pulse wave velocity I"},{"outcome_type":"primary","measure":"PWV II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Pulse wave velocity II"},{"outcome_type":"secondary","measure":"Aortic pressure (AP) I","time_frame":"At baseline","description":"Aortic pressure I"},{"outcome_type":"secondary","measure":"AP II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Aortic pressure II"},{"outcome_type":"secondary","measure":"Body mass (BM) I","time_frame":"At baseline","description":"Body mass I"},{"outcome_type":"secondary","measure":"BM II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Body mass II"},{"outcome_type":"secondary","measure":"Body height (BH) I","time_frame":"At baseline","description":"Body height I"},{"outcome_type":"secondary","measure":"BH II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Body height II"},{"outcome_type":"secondary","measure":"Body mass index (BMI) I","time_frame":"At baseline","description":"Body mass index I"},{"outcome_type":"secondary","measure":"BMI II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Body mass index II"},{"outcome_type":"secondary","measure":"Waist circumference (WC) I","time_frame":"At baseline","description":"Waist circumference I"},{"outcome_type":"secondary","measure":"WC II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Waist circumference II"},{"outcome_type":"secondary","measure":"Hip circumference (HC) I","time_frame":"At baseline","description":"Hip circumference I"},{"outcome_type":"secondary","measure":"HC II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Hip circumference II"},{"outcome_type":"secondary","measure":"Neck circumference (NC) I","time_frame":"At baseline","description":"Neck circumference I"},{"outcome_type":"secondary","measure":"NC II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Neck circumference II"},{"outcome_type":"secondary","measure":"Total fat percentage (TF%) I","time_frame":"At baseline","description":"Total fat percentage I"},{"outcome_type":"secondary","measure":"TF% II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Total fat percentage II"},{"outcome_type":"secondary","measure":"Systolic blood pressure (SBP) I","time_frame":"At baseline","description":"Systolic blood pressure I"},{"outcome_type":"secondary","measure":"SBP II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Systolic blood pressure II"},{"outcome_type":"secondary","measure":"Diastolic blood pressure (DBP) I","time_frame":"At baseline","description":"Diastolic blood pressure I"},{"outcome_type":"secondary","measure":"DBP II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Diastolic blood pressure II"},{"outcome_type":"secondary","measure":"Heart rate (HR) I","time_frame":"At baseline","description":"Heart rate I"},{"outcome_type":"secondary","measure":"HR II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Heart rate II"},{"outcome_type":"secondary","measure":"Blood oxygen saturation (SO2) I","time_frame":"At baseline","description":"Blood oxygen saturation I"},{"outcome_type":"secondary","measure":"SO2 II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Blood oxygen saturation II"},{"outcome_type":"secondary","measure":"Ejection fraction (EF) I","time_frame":"At baseline","description":"Ejection fraction I"},{"outcome_type":"secondary","measure":"EF II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Ejection fraction II"},{"outcome_type":"secondary","measure":"Ambulatory blood pressure monitoring- systolic blood pressure (ABPM SBP) I","time_frame":"At baseline","description":"Ambulatory blood pressure monitoring- systolic blood pressure I"},{"outcome_type":"secondary","measure":"ABPM SBP II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Ambulatory blood pressure monitoring- systolic blood pressure II"},{"outcome_type":"secondary","measure":"Ambulatory blood pressure monitoring- diastolic blood pressure (ABPM DBP) I","time_frame":"At baseline","description":"Ambulatory blood pressure monitoring- diastolic blood pressure I"},{"outcome_type":"secondary","measure":"ABPM DBP II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Ambulatory blood pressure monitoring- diastolic blood pressure II"},{"outcome_type":"secondary","measure":"Metabolic equivalent (MET) I","time_frame":"At baseline","description":"Metabolic equivalent I"},{"outcome_type":"secondary","measure":"MET II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Metabolic equivalent II"},{"outcome_type":"secondary","measure":"Distance in 6-minutes walk (6MW-D) I","time_frame":"At baseline","description":"Distance in 6-minutes walk I"},{"outcome_type":"secondary","measure":"6MW-D II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Distance in 6-minutes walk II"},{"outcome_type":"secondary","measure":"aspartate aminotransferase (AST) I","time_frame":"At baseline","description":"Blood concentration of aspartate aminotransferase I"},{"outcome_type":"secondary","measure":"AST II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Blood concentration of aspartate aminotransferase II"},{"outcome_type":"secondary","measure":"ALT II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Blood concentration of alanine aminotransferase II"},{"outcome_type":"secondary","measure":"total bilirubin (TB) I","time_frame":"At baseline","description":"Blood concentration of total bilirubin I"},{"outcome_type":"secondary","measure":"TB II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Blood concentration of total bilirubin II"},{"outcome_type":"secondary","measure":"indirect bilirubin (IB) I","time_frame":"At baseline","description":"Blood concentration of indirect bilirubin I"},{"outcome_type":"secondary","measure":"IB II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Blood concentration of indirect bilirubin II"},{"outcome_type":"secondary","measure":"direct bilirubin (DB) I","time_frame":"At baseline","description":"Blood concentration of direct bilirubin I"},{"outcome_type":"secondary","measure":"DB II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Blood concentration of direct bilirubin II"},{"outcome_type":"secondary","measure":"gamma-glutamyltransferase (GGTP) I","time_frame":"At baseline","description":"Blood concentration of gamma-glutamyltransferase I"},{"outcome_type":"secondary","measure":"TCH II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Blood concentration of total cholesterol II"},{"outcome_type":"secondary","measure":"low density lipoprotein (LDL) I","time_frame":"At baseline","description":"Blood concentration of low density lipoprotein I"},{"outcome_type":"secondary","measure":"LDL II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Blood concentration of low density lipoprotein II"},{"outcome_type":"secondary","measure":"high density lipoprotein (HDL) I","time_frame":"At baseline","description":"Blood concentration of high density lipoprotein I"},{"outcome_type":"secondary","measure":"HDL II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Blood concentration of high density lipoprotein II"},{"outcome_type":"secondary","measure":"triglycerides (TG) I","time_frame":"At baseline","description":"Blood concentration of triglycerides I"},{"outcome_type":"secondary","measure":"TG II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Blood concentration of triglycerides II"},{"outcome_type":"secondary","measure":"apolipoprotein A (ApoA) I","time_frame":"At baseline","description":"Blood concentration of apolipoprotein A I"},{"outcome_type":"secondary","measure":"ApoA II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Blood concentration of apolipoprotein A II"},{"outcome_type":"secondary","measure":"insulin (INS) I","time_frame":"At baseline","description":"Blood concentration of insulin I"},{"outcome_type":"secondary","measure":"INS II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Blood concentration of insulin II"},{"outcome_type":"secondary","measure":"glucose (GLU) I","time_frame":"At baseline","description":"Blood concentration of glucose I"},{"outcome_type":"secondary","measure":"GLU II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Blood concentration of glucose II"},{"outcome_type":"secondary","measure":"creatinine (CREA) I","time_frame":"At baseline","description":"Blood concentration of creatinine I"},{"outcome_type":"secondary","measure":"CREA II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Blood concentration of creatinine II"},{"outcome_type":"secondary","measure":"C-reactive protein (CRP) I","time_frame":"At baseline","description":"Blood concentration of C-reactive protein I"},{"outcome_type":"secondary","measure":"CRP II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Blood concentration of C-reactive protein II"},{"outcome_type":"secondary","measure":"adropin (ADR) I","time_frame":"At baseline","description":"Blood concentration of adropin I"},{"outcome_type":"secondary","measure":"ADR II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Blood concentration of adropin II"},{"outcome_type":"secondary","measure":"neopterin (NEOPT) I","time_frame":"At baseline","description":"Blood concentration of neopterin I"},{"outcome_type":"secondary","measure":"NEOPT II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Blood concentration of neopterin II"},{"outcome_type":"secondary","measure":"N-terminal natriuretic propeptide type B (NTpro-BNP) I","time_frame":"At baseline","description":"Blood concentration of N-terminal natriuretic propeptide type B I"},{"outcome_type":"secondary","measure":"NTpro-BNP II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Blood concentration of N-terminal natriuretic propeptide type B II"},{"outcome_type":"secondary","measure":"magnesium (Mg) I","time_frame":"At baseline","description":"Blood concentration of magnesium I"},{"outcome_type":"secondary","measure":"Mg II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Blood concentration of magnesium II"},{"outcome_type":"secondary","measure":"homocysteine (Hcy) I","time_frame":"At baseline","description":"Blood concentration of homocysteine I"},{"outcome_type":"secondary","measure":"Hcy II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Blood concentration of homocysteine II"},{"outcome_type":"secondary","measure":"troponin (TROP) I","time_frame":"At baseline","description":"Blood concentration of troponin I"},{"outcome_type":"secondary","measure":"TROP II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Blood concentration of troponin II"},{"outcome_type":"secondary","measure":"interleukin 6 (IL6) I","time_frame":"At baseline","description":"Blood concentration of interleukin 6 I"},{"outcome_type":"secondary","measure":"IL6 II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Blood concentration of interleukin 6 II"},{"outcome_type":"secondary","measure":"tumor necrosis factor (TNF) I","time_frame":"At baseline","description":"Blood concentration of tumor necrosis factor I"},{"outcome_type":"secondary","measure":"TNF II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Blood concentration of tumor necrosis factor II"},{"outcome_type":"secondary","measure":"vascular endothelial growth factor (VEGF) I","time_frame":"At baseline","description":"Blood concentration of vascular endothelial growth factor I"},{"outcome_type":"secondary","measure":"VEGF II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Blood concentration of vascular endothelial growth factor II"},{"outcome_type":"secondary","measure":"leptin (LPT) I","time_frame":"At baseline","description":"Blood concentration of leptin I"},{"outcome_type":"secondary","measure":"LPT II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Blood concentration of leptin II"},{"outcome_type":"secondary","measure":"VEGF polymorphism","time_frame":"At baseline","description":"Polymorphism of the VEGF gene"},{"outcome_type":"secondary","measure":"Urine concentration of magnesium (U-Mg) I","time_frame":"At baseline","description":"Urine concentration of magnesium I"},{"outcome_type":"secondary","measure":"U-Mg II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Urine concentration of magnesium II"},{"outcome_type":"secondary","measure":"Hair content of magnesium (H-Mg) I","time_frame":"At baseline","description":"Hair content of magnesium I"},{"outcome_type":"secondary","measure":"H-Mg II","time_frame":"After intervention completion- an average of 2 weeks from baseline","description":"Hair content of magnesium II"}]}
{"nct_id":"NCT04008459","start_date":"2019-04-06","enrollment":41,"brief_title":"Walking and Balance Related to Sagittal Spinal Posture Alignment","official_title":"WiSPA: Walking and Balance Related to Sagittal Spinal Posture and Alignment","primary_completion_date":"2020-07-12","study_type":"Observational","rec_status":"Terminated","completion_date":"2020-08-18","last_update":"2020-09-14","description":"This study aims to improve understanding of the relationship between spinal alignment and walking and balance in people who have degenerative spinal conditions.","other_id":"14031","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","population":"Adults with a degenerative spinal condition who have been referred to outpatient\r\n        physiotherapy treatment.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Participant is diagnosed with a degenerative spinal condition.\r\n\r\n          -  Participant is willing and able to give informed consent for participation in the\r\n             study.\r\n\r\n          -  Men and women aged 18 years or older.\r\n\r\n          -  Participant is able to understand and participate safely in a physiotherapy\r\n             measurement assessment.\r\n\r\n          -  Participant is enrolled in physiotherapy.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Participant is unable to stand independently.\r\n\r\n          -  Participant has a neurological condition which alters motor function and/or postural\r\n             control.\r\n      ","sponsor":"University of Oxford","sponsor_type":"Other","conditions":"Hyperkyphosis|Walking, Difficulty|Balance; Distorted|Spinal Disease|Osteoporosis|Spine Degeneration","interventions":[{"intervention_type":"Other","name":"Other: Therapeutic exercise class","description":"Physiotherapy exercise class includes education, stretching, strengthening, posture and balance interventions."}],"outcomes":[{"outcome_type":"primary","measure":"Change in sagittal spinal alignment","time_frame":"6 weeks post-baseline","description":"Alignment of the spine in the sagittal plane measured by a surface topography method"},{"outcome_type":"secondary","measure":"Sagittal spinal alignment","time_frame":"6 months","description":"Alignment of the spine in the sagittal plane measured by a surface topography method"},{"outcome_type":"secondary","measure":"2 minute walk test","time_frame":"6 weeks and 6 months","description":"Distance walked in 2 minutes to measure exercise capacity"},{"outcome_type":"secondary","measure":"Gait analysis","time_frame":"6 weeks and 6 months","description":"Spatiotemoral gait parameters measured using inertial measurement units"},{"outcome_type":"secondary","measure":"Tragus to wall distance","time_frame":"6 weeks and 6 months","description":"Forward posture measurement using the distance from the ear to the wall"},{"outcome_type":"secondary","measure":"Four Square Step Test","time_frame":"6 weeks and 6 months","description":"Dynamic balance test involving multidirectional stepping over obstacles"},{"outcome_type":"secondary","measure":"Timed loaded standing test","time_frame":"6 weeks and 6 months","description":"Measurement of back extensor muscle strength and endurance"},{"outcome_type":"secondary","measure":"36-item Short Form Health Survey (SF-36)","time_frame":"6 weeks and 6 months","description":"Health survey measuring aspects of quality of life. The questionnaire contains 36 questions which form 8 subscales: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. Each question is directly transformed into a 0-100 scale with the lower the score the more disability."},{"outcome_type":"secondary","measure":"Visual analogue pain scale","time_frame":"6 weeks and 6 months","description":"Measurement of pain in a participant's back. The scale is along a horizontal 10 cm line with markings from 0 to 10, 0 indicating no pain and 10 indicating the worst pain imaginable."},{"outcome_type":"secondary","measure":"Activities-specific Balance Confidence Scale","time_frame":"6 weeks and 6 months","description":"Questionnaire measuring balance confidence in various situations. It contains 16 questions in which participants rate their confidence in performing the activities on a scale from 0-100, 0 representing no confidence and 100 representing complete confidence. The total score is calculated to be on a similar 0 to 100 scale."},{"outcome_type":"secondary","measure":"Modified gait efficacy scale","time_frame":"6 weeks and 6 months","description":"Questionnaire measuring walking confidence and self-efficacy. Each of the 10 items is scored on a 10-point Likert scale with 1 representing no confidence and 10 representing complete confidence. The total score ranges from 10-100."},{"outcome_type":"secondary","measure":"Sagittal spinal alignment","time_frame":"Within 2 weeks of baseline","description":"Reliability re-test of alignment of the spine in the sagittal plane measured by a surface topography method"}]}
{"nct_id":"NCT04149652","start_date":"2019-04-05","phase":"N/A","enrollment":66,"brief_title":"Lung Elastrosonography in Diagnosis and Stratification of COPD and Fibrosis","official_title":"Role of Lung Ultrasonography for Detecting COPD and Fibrosis and Stratifying the Risk of COPD in Healthy Subjects","primary_completion_date":"2020-12-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-12-30","last_update":"2021-01-13","description":"Elastosonography is an advanced ultrasound technique, nowadays available in many portable systems, allowing to measure elasticity and stiffness of parenchymatous organs. Its main current applications concern the advanced diagnostics of liver, thyroid and breast nodules. Few studies have applied elastosonography to the respiratory system, and to date no-one has evaluated the elasticity of lung parenchyma in COPD and only one in pulmonary fibrosis. The primary aim of this study is to compare the elasticity features of lung parenchyma, measured by bedside ultrasound integrated with ultrasonography, among three groups of subjects: 1. patients with COPD and/or lung fibrosis; 2. smokers with no functional evidence of COPD or fibrosis; 3. healthy non-smoking volunteers. The secondary aim is to verify the possible correlation of elastosonography-related parameters of lung elasticity/stiffness with results of lung function tests. One hundred and thirty-eight subjects (46 per group) will be enrolled in this experimental study, on both inpatient and outpatient basis. The presence or absence of COPD or fibrosis will be assessed integrating personal history, imaging tests and functional tests prior to enrolment. Smoking habits will also be carefully investigated. Excluded from the study will be all subjects with acute COPD flares, acute respiratory failure, inability to undergo lung ultrasound examination and lung function tests, cognitive impairment, severe motoric disability, cancer, poor survival prognosis. Each participant will undergo standard lung function tests and bediside ultrasound examination integrated with lung elastosonography during the same day. Lung function tests will be performed with a Carefusion MSC Body spirometer following standard procedures. Lung ultrasound will be performed by a skilled physician, using the convex probe of an Esaote Mylab Seven ultrasound system (Esaote, Genova, Italy), equipped with strain elastography module ElaXto. The participant will remain in the sitting position for the whole ultrasound/elastography procedure, with the examiner systematically scanning intercostal spaces on both sides of the back thorax. After performing a standard lung ultrasound scan to verify the absence of consolidations or signs of respiratory diseases other than COPD, the examiner will activate the elastography module, performing little compressions with the wrist on the convex probe, to obtain adequate elastography images combining ranges of red, green and blue colors. Images will then be analyzed with the software ElaXto, to obtain the percentage of stiffness in areas of interest of lung parenchyma. Statistical analyses will be focused on comparison of stiffness index across different groups, and on correlation of elastosonographic parameters with lung function tests (FEV1, Tiffeneau index).","other_id":"614/2018/DISP/AOUPR","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","intervention_model_description":"Experimental study of feasibility of an ultrasound technique for diagnostic purposes","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        COPD/fibrosis group\r\n\r\n          -  Established anamnestic record of COPD or fibrosis confirmed by imaging and functional\r\n             tests\r\n\r\n          -  Capacity to maintain the sitting position for chest ultrasound\r\n\r\n          -  Capacity and willingness to collaborate to the execution of lung function tests\r\n\r\n        Smoker group\r\n\r\n          -  Active smoking habit or personal history of hard smoking (at least 10 cigarettes/day)\r\n             in the five year period before evaluation\r\n\r\n          -  Presence of a high risk of COPD according to GOLD guidelines\r\n\r\n          -  No anamnestic, clinical or functional evidence of COPD\r\n\r\n          -  Capacity to maintain the sitting position for chest ultrasound\r\n\r\n          -  Capacity and willingness to collaborate to the execution of lung function tests\r\n\r\n        Healthy non-smoking volunteer group\r\n\r\n          -  Absence of a current or past smoking habit\r\n\r\n          -  Absence of a high risk of COPD according to GOLD guidelines\r\n\r\n          -  Capacity to maintain the sitting position for chest ultrasound\r\n\r\n          -  Capacity and willingness to collaborate to the execution of lung function tests\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Acute respiratory failure\r\n\r\n          -  Cognitive impairment or dementia\r\n\r\n          -  Severe motoric disability with inability to maintain the sitting position\r\n\r\n          -  Lung diseases\r\n\r\n          -  Severe heart failure\r\n\r\n          -  Severe kidney or liver failure\r\n\r\n          -  Cancer\r\n\r\n          -  Severe neuromuscular diseases\r\n\r\n          -  Any other condition that could represent a bias for the accuracy of results\r\n      ","sponsor":"Azienda Ospedaliero-Universitaria di Parma","sponsor_type":"Other","conditions":"Chronic Obstructive Pulmonary Disease|Smoker Lung","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Lung Elastosonography","description":"Bedside lung ultrasound integrated with lung elastosonography, performed by using the convex probe of an Esaote Mylab Seven ultrasound system (Esaote, Genova, Italy), equipped with the strain elastography module ElaXto."}],"outcomes":[{"outcome_type":"primary","measure":"Elasticity score of lung parenchyma","time_frame":"The same moment of baseline evaluation","description":"Qualitative index of elasticity measured by lung ultrasonography (visual score ranging from 1 to 3, 1=elastic pattern 3=rigid pattern)"},{"outcome_type":"primary","measure":"Strain index of lung parenchyma","time_frame":"The same moment of baseline evaluation","description":"Quantitative index of stiffness of lung parenchyma measured by lung ultrasonography (percentage of stiffness ranging from 0% to 100%, with 100% representing extreme rigidity)"}]}
{"nct_id":"NCT03913143","start_date":"2019-04-04","phase":"Phase 2/Phase 3","enrollment":36,"brief_title":"A Study to Evaluate Efficacy, Safety, Tolerability and Exposure After a Repeat-dose of Sepofarsen (QR-110) in LCA10 (ILLUMINATE)","official_title":"Double-masked, Randomized, Controlled, Multiple-dose Study to Evaluate Efficacy, Safety, Tolerability and Syst. Exposure of QR-110 in Leber's Congenital Amaurosis (LCA) Due to c.2991+1655A>G Mutation (p.Cys998X) in the CEP290 Gene","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2021-12-31","last_update":"2021-01-11","description":"The purpose of this double-masked, randomized, controlled, multiple-dose study is to evaluate the efficacy, safety, tolerability and systemic exposure of sepofarsen (QR-110) administered via intravitreal injection in subjects with Leber's Congenital Amaurosis (LCA) due to the CEP290 p.Cys998X mutation after 24 months of treatment","other_id":"PQ-110-003","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":8,"population":"","criteria":"\n        Main Inclusion Criteria:\r\n\r\n          -  Male or female,  8 years of age at Screening with a clinical diagnosis of LCA and a\r\n             molecular diagnosis of homozygosity or compound heterozygosity for the CEP290\r\n             p.Cys998X mutation, based on genotyping analysis at Screening. Historic genotyping\r\n             results from a certified laboratory are acceptable with Sponsor approval.\r\n\r\n          -  BCVA greater or equal to Logarithm of the Minimum Angle of Resolution (LogMAR) +3.0,\r\n             and equal or worse than LogMAR + 0.4 in the treatment eye.\r\n\r\n          -  Detectable outer nuclear layer (ONL) in the area of the macula.\r\n\r\n          -  An electroretinogram (ERG) result consistent with LCA. A historic ERG result may be\r\n             acceptable for eligibility.\r\n\r\n        Main Exclusion Criteria:\r\n\r\n          -  Any contraindication to IVT injection according to the Investigator's clinical\r\n             judgment and international guidelines (Avery 2014).\r\n\r\n          -  Any ocular and/or general disease or condition that could compromise subject's safety\r\n             or interfere with assessment of efficacy and safety, as determined by the\r\n             Investigator.\r\n\r\n          -  Prior receipt of intraocular surgery or IVT injection within 3 months prior to study\r\n             start or planned intraocular surgery or procedure during the course of the study.\r\n\r\n          -  Use of any investigational drug or device within 90 days or 5 half-lives of Day 1,\r\n             whichever is longer, or plans to participate in another study of a drug or device\r\n             during the PQ-110-003 study period.\r\n\r\n          -  Any prior receipt of genetic therapy for LCA.\r\n      ","sponsor":"ProQR Therapeutics","sponsor_type":"Industry","conditions":"Blindness|Leber Congenital Amaurosis 10|Leber Congenital Amaurosis|Vision Disorders|Sensation Disorders|Neurologic Manifestations|Eye Diseases|Eye Diseases, Hereditary|Eye Disorders Congenital|Retinal Disease","interventions":[{"intervention_type":"Drug","name":"Drug: sepofarsen","description":"RNA antisense oligonucleotide for intravitreal injection"},{"intervention_type":"Other","name":"Other: Sham","description":"Sham intravitreal injection (no experimental drug administered)"}],"outcomes":[{"outcome_type":"secondary","measure":"Change in BCVA between two QR-110 dose groups","time_frame":"12 and 24 months","description":"Change in BCVA relative to baseline in the Dose 1 QR-110 dose group versus the dose 2 QR-110 dose group"},{"outcome_type":"primary","measure":"Mean change in BCVA after 12 months","time_frame":"12 months","description":"Mean change in Best-corrected visual acuity (BCVA) relative to baseline after 12 months of treatment versus sham"},{"outcome_type":"secondary","measure":"Change in BCVA to baseline in pooled QR-110 subjects","time_frame":"12 and 24 months","description":"Change in BCVA in both QR-110 dose groups pooled relative to baseline"},{"outcome_type":"secondary","measure":"Percentage of subjects ≥-0.3 LogMAR change in BCVA vs sham","time_frame":"12 and 24 months","description":"Percentage of subjects with baseline BCVA ≥ 1.7 Logarithm of the minimum angle of resolution (LogMAR) with ≥ 0.3 LogMAR change in BCVA in treated versus sham"},{"outcome_type":"secondary","measure":"Percentage of subjects <1.7 Logmar with clinical meaningful improvement in mobility course score","time_frame":"12 and 24 months","description":"Percentage of subjects with baseline BCVA < 1.7 LogMAR with a clinically meaningful improvement in mobility course score in treated versus sham"},{"outcome_type":"secondary","measure":"Change in mobility course score","time_frame":"12 and 24 months","description":"Change in mobility course score relative to baseline in the treatment eye versus sham"},{"outcome_type":"secondary","measure":"Change in mobility course score binocular vision","time_frame":"12 and 24 months","description":"Change in mobility course score binocular vision versus baseline versus sham"},{"outcome_type":"secondary","measure":"Rate of change in oculomotor instability from baseline","time_frame":"12 and 24 months","description":"Rate of change in oculomotor instability from baseline"},{"outcome_type":"secondary","measure":"Full-field light sensitivity threshold (FST) testing for white light from baseline","time_frame":"12 and 24 months","description":"Full-field light sensitivity threshold (FST) testing for white light from baseline"},{"outcome_type":"secondary","measure":"Full-field light sensitivity threshold (FST) testing for red light from baseline","time_frame":"12 and 24 months","description":"Full-field light sensitivity threshold (FST) testing for red light from baseline"},{"outcome_type":"secondary","measure":"Full-field light sensitivity threshold (FST) testing for blue light from baseline","time_frame":"12 and 24 months","description":"Full-field light sensitivity threshold (FST) testing for blue light from baseline"},{"outcome_type":"secondary","measure":"Change in photoreceptor inner/outer segment by OCT","time_frame":"12 and 24 months","description":"Change in photoreceptor inner segment/outer segment (inner segment [IS]/outer segment [OS]; ellipsoid zone [EZ] line) assessed by OCT relative to baseline"},{"outcome_type":"secondary","measure":"Change in patient reported visual function via VFQ-25 (adults)","time_frame":"12 and 24 months","description":"Change in patient reported visual function, as measured by the Visual Function Questionnaire-25 (VFQ-25) score for adult subjects relative to baseline"},{"outcome_type":"secondary","measure":"Change in patient reported visual function via CVAQC (pediatrics)","time_frame":"12 and 24 months","description":"Change in patient reported visual function, as measured by the Cardiff Visual Ability Questionnaire for Children (CVAQC) for pediatric subjects relative to baseline"},{"outcome_type":"secondary","measure":"Change in the Patient Global Impressions of Severity (PGI-S)","time_frame":"12 and 24 months","description":"Change in the patient-reported outcome (PRO) Patient Global Impressions of Severity (PGI-S)"},{"outcome_type":"secondary","measure":"Change in the Patient Global Impressions of Change (PGI-C)","time_frame":"12 and 24 months","description":"Change in the PRO Patient Global Impressions of Change (PGI-C)"},{"outcome_type":"secondary","measure":"Change in ERG","time_frame":"12 months","description":"Change in Electroretinogram (ERG) via International Society for Clinical Electrophysiology of Vision [ISCEV] standard for full-field clinical ERG) relative to baseline"},{"outcome_type":"secondary","measure":"Changes in ophthalmic examination findings","time_frame":"12 and 24 months","description":"Changes in ophthalmic examination findings"},{"outcome_type":"secondary","measure":"Severity of ocular AEs","time_frame":"12 and 24 months","description":"Severity of ocular AEs"},{"outcome_type":"secondary","measure":"Frequency of non-ocular AEs","time_frame":"12 and 24 months","description":"Frequency of non-ocular AEs"}]}
{"nct_id":"NCT04639687","start_date":"2019-04-03","phase":"N/A","enrollment":68,"brief_title":"Food as Medicine: Evaluating the Impact of Home-delivered Vegetables and Whole Grains on Diet of Food-insecure Families","official_title":"Food as Medicine: Evaluating the Impact of Home-delivered Vegetables and Whole Grains on Diet of Food-insecure Families","primary_completion_date":"2020-11-13","study_type":"Interventional","rec_status":"Completed","completion_date":"2021-01-27","last_update":"2021-05-28","description":"Food insecurity predisposes to poor diet, thereby increasing risk for diet-sensitive chronic disease. This trial is to evaluate the impact of a model of weekly home-delivery of locally-grown vegetables along with selected whole grains on diet among low-income children living in a household with food insecurity. The investigators plan to enroll children (10-15 years) who will participate along with their parent/caregiver. Intervention will consist of 12 weeks of weekly delivered food plus recipes and text-messaged links to cooking instruction. Dyads will be randomized (2:1) to either immediate intervention or a wait-list control group, and diet and diet-related behaviors will be assessed in-person as well as over the telephone.","other_id":"2018-062","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Group A is randomized to intermediate intervention, and change in measured outcomes is changed to that of Group B, which is a wait-list control group. Group B gets intervention later, but data contributes to follow-up up data rather than randomized controlled trial data.","sampling_method":"","gender":"All","minimum_age":10,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  child between 10-15 at time of enrollment whose caregiver screens as positive for food\r\n             insecurity during visit to primary clinic\r\n\r\n          -  child must reside in household with caregiver at least 5 out of 7 days a week\r\n\r\n          -  dyad must reside in Oakland, CA (delivery range for farm)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Not able to consume wheat or other grains\r\n\r\n          -  Caregiver and child must have cognitive capability to complete survey materials\r\n             (exclude non-verbal autistic, developmental delay)\r\n\r\n          -  Unable to communicate in either English or Spanish\r\n      ","sponsor":"UCSF Benioff Children's Hospital Oakland","sponsor_type":"Other","conditions":"Food Insecurity|Nutrition Poor","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Food as Medicine Delivery","description":"12 consecutive weeks of home-delivered vegetables plus whole grain foods along with weekly text containing educational video"}],"outcomes":[{"outcome_type":"primary","measure":"vegetable consumption (servings/day) for child","time_frame":"6 months","description":"24-diet diet recall (total vegetables)"},{"outcome_type":"primary","measure":"whole grains consumption (ounce equivalents/day) for child","time_frame":"6 months","description":"24-diet diet recall (total vegetables)"},{"outcome_type":"primary","measure":"reported total cups of vegetables per day (for adult)","time_frame":"6 months","description":"Fruit and Vegetable checklist"},{"outcome_type":"secondary","measure":"food security","time_frame":"3 months","description":"Core food security module (up to 18 questions)"},{"outcome_type":"secondary","measure":"food security","time_frame":"6 months","description":"Core food security module (up to 18 questions)"},{"outcome_type":"secondary","measure":"Body mass Index","time_frame":"6 months","description":"Body mass index, calculated"},{"outcome_type":"secondary","measure":"Liking Scale (Vegetables)","time_frame":"6 months","description":"This scale (never tried, do not like, like a little, like a lot) has been validated in children as young as 4th grade. Responses will be dichotomized to represent \"Ever tried\" ('Never tried' versus all other responses) and \"Like it\" ('Never tried' or 'do not like' versus 'like a little' and 'like a lot')"},{"outcome_type":"secondary","measure":"Liking Scale (Whole grains)","time_frame":"6 months","description":"This scale (never tried, do not like, like a little, like a lot) has been validated in children as young as 4th grade. Responses will be dichotomized to represent \"Ever tried\" ('Never tried' versus all other responses) and \"Like it\" ('Never tried' or 'do not like' versus 'like a little' and 'like a lot')"}]}
{"nct_id":"NCT03879434","start_date":"2019-04-02","enrollment":50,"brief_title":"Routine Application of Ostenil Mini in Patients With Rhizarthrosis","official_title":"Routine Application of Ostenil Mini in Patients With Rhizarthrosis","primary_completion_date":"2024-08-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2024-08-31","last_update":"2021-09-16","description":"PMCF study to observe the routine application of Ostenil Mini in the treatment of pain and restricted mobility in degenerative and traumatic changes of the CMC joint.","other_id":"OSTCMC-PMCF-DE-2018-01","observational_model":"Other","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":99,"population":"Adult Patients with Rhizarthrosis and a Recommendation for Treatment with Ostenil Mini.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subjects  18 years of age and in good general health condition\r\n\r\n          -  Signed informed consent\r\n\r\n          -  Existing Ostenil Mini recommendation for the treatment of rhizarthrosis\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Known hypersensitivity to one of the Ostenil Mini components\r\n\r\n          -  Known pregnancy or lactating females\r\n\r\n          -  Presence of coagulation disorder\r\n\r\n          -  Subjects not capable of contracting and of understanding the nature, risks,\r\n             significance and implications of the clinical investigation and unable to form a\r\n             rational intention in the light of these facts\r\n\r\n          -  Subjects unable to understand informed consent or having a high probability of non\r\n             compliance to the study procedures and / or non completion of the study according to\r\n             investigator's judgement (e.g. illiteracy, insufficient knowledge of local language)\r\n      ","sponsor":"TRB Chemedica AG","sponsor_type":"Industry","conditions":"Rhizarthrosis","interventions":[{"intervention_type":"Device","name":"Device: Ostenil Mini","description":"Ostenil Mini is a CE-certified viscoelastic solution for injection into the Joint cavity, containing 1.0 % sodium hyaluronate from fermentation"}],"outcomes":[{"outcome_type":"primary","measure":"Change of Pain Intensity compared to Baseline (VAS-slider)","time_frame":"Day 7, Day 14, Day 84 after last injection, Day 168 after last injection","description":"Evaluation of Pain Intensity by the Patient on a 10 cm VAS-slider. (10 cm equal the worst pain)"},{"outcome_type":"primary","measure":"Change of Subjective Therapy Evaluation (FIHOA Questionnaire, 4 grade scale) compared to Baseline","time_frame":"Day 7, Day 14, Day 84 after last injection, Day 168 after last injection","description":"Functional Index for Hand OsteoArthritis (FIHOA) to assess hand-OA related functional impairment on a 4-grade scale"},{"outcome_type":"primary","measure":"Change of Subjective Quality of Life Evaluation (Questionnaire with 5 Point Likert scale) compared to Baseline","time_frame":"Day 7, Day 14, Day 84 after last injection, Day 168 after last injection","description":"Questionnaire to assess hand-OA related Quality of Life on a 5-grade scale"},{"outcome_type":"primary","measure":"Change of Subjective Symptom Evaluation (Overall Impression on a scale from 1 to 5)","time_frame":"Day 7, Day 14, Day 84 after last injection, Day 168 after last injection","description":"The Change of Overall Subjective Symptom Evaluation on a scale from 1 (much improved) to 5 (much worse)"},{"outcome_type":"primary","measure":"Incidence of Treatment-Emergent Adverse Events","time_frame":"Up to Day 252 after the last injection"},{"outcome_type":"primary","measure":"Change of Key Pinch Strength compared to Baseline (Pinch Gauge)","time_frame":"Day 7, Day 14, Day 84 after last injection, Day 168 after last injection","description":"Measurement of Key Pinch in kilograms with a Pinch Gauge"},{"outcome_type":"primary","measure":"Change of Tip Pinch Strength compared to Baseline (Pinch Gauge)","time_frame":"Day 7, Day 14, Day 84 after last injection, Day 168 after last injection","description":"Measurement of Tip Pinch in kilograms with a Pinch Gauge"},{"outcome_type":"primary","measure":"Change of Palmar Pinch Strength compared to Baseline (Pinch Gauge)","time_frame":"Day 7, Day 14, Day 84 after last injection, Day 168 after last injection","description":"Measurement of Palmar Pinch in kilograms with a Pinch Gauge"}]}
{"nct_id":"NCT03870646","start_date":"2019-04-01","phase":"Phase 3","enrollment":164,"brief_title":"Nebulized hypErtonic Saline for Better Prevention of mUcus pLug in Critical Adult Tracheostomized Patients","official_title":"Nebulized hypErtonic Saline for Better Prevention of mUcus pLug in Critical Adult Tracheostomized Patients (the NEBULA Study). A Pilot Randomized Controlled Trial","primary_completion_date":"2020-10-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2020-12-31","last_update":"2019-03-12","description":"Tracheostomy is an important tool in the management of respiratory failure in the critically ill patient under mechanical ventilation. Although mechanical ventilation can be a lifesaving intervention, it is also known to carry several side-effects and risks. Among the most frequent complications of mechanical ventilation, obstruction of the airway secondary to a mucus plug is both life threatening and a prevalent phenomenon related to mucociliary system dysfunction, artificial airway itself and the loss of strength that prevents adequate airway clearance. The main indication of tracheostomy is the need for prolonged mechanical ventilation that usually occurs in more severe patients, this circumstance having also been related to the development of intensive care unit (ICU) acquired weakness. Currently, the approach to secretion clearance in critical patients is focused on rehabilitation therapy and humidification. Hypertonic saline (HS) is largely used in cystic fibrosis to increase airways clearance while little evidence is available in other settings although promising results have been reported. In this sense, the use of HS could be beneficial in the prevention of airway obstruction in tracheostomized critical patients.","other_id":"2018-11-1-HCUVA","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","intervention_model_description":"Unicentre, randomized, two arm, double-blind, controlled trial.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age >= 18 years.\r\n\r\n          -  Respiratory support through tracheostomy performed during ICU stay.\r\n\r\n          -  Informed consent signed by the relatives or legal representative of the patient.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnancy.\r\n\r\n          -  Any terminal disease.\r\n\r\n          -  Known hypersensitivity to any component of Hyaneb (Hypertonic saline of NaCl (7%) in\r\n             combination with hyaluronic acid).\r\n\r\n          -  Participation in another research study.\r\n\r\n          -  Any other condition that, according to the investigator, may prevent a participant to\r\n             complete all the procedures required.\r\n      ","sponsor":"Hospital Universitario Virgen de la Arrixaca","sponsor_type":"Other","conditions":"Critical Illness|Tracheostomy Complication|Mechanical Ventilation Complication|Plug; Mucus","interventions":[{"intervention_type":"Combination Product","name":"Combination Product: Hypertonic saline of NaCl (7%) in combination with hyaluronic acid","description":"Critical adult tracheostomized patients will receive, in the intervention arm, nebulized Hypertonic saline of NaCl (7%) in combination with hyaluronic acid 5ml twice daily for 10 days from the day of the tracheotomy or until decannulation or discharge from the ICU if it happens before. The treatment will be applied through a jet nebulizer located in the inspiratory branch in patients under mechanical ventilation and in the sole tubulant of patients under T-piece oxygen regimen. Salbutamol 100 micrograms / dose, suspension for inhalation in pressure pack: 2 inhalations through the tracheostomy cannula 10 minutes before the application of the nebulization with hypersaline in order to avoid bronchospasm."},{"intervention_type":"Combination Product","name":"Combination Product: Isotonic saline of NaCl (0,9%)","description":"Critical adult tracheostomized patients will receive, in the control arm, nebulized isotonic saline of NaCl (0,9%) 5ml twice daily for 10 days from the day of the tracheotomy or until decannulation or discharge from the ICU if it happens before. The treatment will be applied through a jet nebulizer located in the inspiratory branch in patients under mechanical ventilation and in the sole tubulant of patients under T-piece oxygen regimen. Salbutamol 100 micrograms / dose, suspension for inhalation in pressure pack: 2 inhalations through the tracheostomy cannula 10 minutes before the application of the nebulization with isotonic saline in order to avoid bronchospasm."}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of patients with mucus plug","time_frame":"10 days from the day of the tracheotomy or until decannulation or discharge from the ICU if it happens before.","description":"Mucus plug will be considered when there is a deterioration of the respiratory support accompanied by at least one of the following:\r\nAn inability to pass the aspiration catheter through the orotracheal tube or the tracheostomy tube.\r\nSudden hypoxia with physical and / or radiological examination compatible with atelectasis.\r\nNeed for urgent bronchoscopy with direct vision of the mucous plug."},{"outcome_type":"secondary","measure":"Length of mechanical ventilation","time_frame":"From the start date of mechanical ventilation to the date of its withdrawal or date of death from any cause, whichever came first, assessed up to 12 months","description":"Number of days under mechanical ventilation"},{"outcome_type":"secondary","measure":"Percentage of patients died during ICU stay","time_frame":"From date of ICU admission until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 12 months","description":"Percentage of patients died during ICU stay"},{"outcome_type":"secondary","measure":"Percentage of patients died during hospital stay","time_frame":"From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 15 month","description":"Percentage of patients died during hospital stay"},{"outcome_type":"secondary","measure":"ICU length of stay","time_frame":"From date of ICU admission until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 12 month","description":"Number of days admitted to the ICU"},{"outcome_type":"secondary","measure":"Hospital length of stay","time_frame":"From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 15 month","description":"Number of days admitted to the hospital"}]}
{"nct_id":"NCT04832386","start_date":"2019-03-30","enrollment":60,"brief_title":"COMPRESSION GARMENTS in BREAST CANCER-RELATED LYMPHEDEMA","official_title":"COMPLIANCE TO COMPRESSION GARMENTS AND RELATED FACTORS AMONG PATIENTS With BREAST CANCER-RELATED LYMPHEDEMA","primary_completion_date":"2019-08-29","study_type":"Observational","rec_status":"Completed","completion_date":"2019-08-29","last_update":"2021-04-05","description":"Breast cancer is the most common cancer in women. It is an important health problem that has been increasingly encountered in recent years. With the advances in treatment, the survival time after breast cancer is prolonged, and as a result, many women face certain diseases during this period. One of these diseases, breast cancer-related lymphedema, is characterized by abnormal accumulation of protein-rich fluid in the interstitial tissue, which can occur at any time after breast cancer surgery or radiotherapy and is a major cause of morbidity. The aims of the treatment of lymphedema are to reduce edema, prevent the increase of edema, prevent infections, protect skin integrity, range of motion and limb functions. Complete Decongestive Therapy (CDT) is recommended by the International Society of Lymphology (ISL) as the international contemporary standard treatment for BCRL(breast cancer related lymphedema) treatment. CDT is a treatment method that includes manual lymph drainage (MLD), multilayer bandaging (Multilayer, short-stretch compression bandaging), exercise, skin care and compression garment. Compression garments, which are the most important component of the second phase of CDT, reduce the interstitial pressure of the extremity with the pressure they apply, and reduce capillary filtration and lymph production. Regular use of compression garments is very important during the treatment process. It is recommended that compression garments be worn during all waking hours. The success of compression garments is closely related to the patient's compliance with the treatment. Patients with lymphedema may need to wear compression garments for life. Wearing compression garments may have some difficulties for patients and this may affect compliance and adherence to treatment. The aim of this study is to investigate the compliance to compression garments and related factors among patients with breast cancer-related lymphedema.","other_id":"DokuzEU.Com.Garments","observational_model":"Other","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Diagnosed with breast cancer releated lymphedema","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Being over 18 years of age\r\n\r\n          -  Diagnosed with breast cancer related lymphedema\r\n\r\n          -  Having been prescribed compression garments\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  cognitive and / or psychiatric illness\r\n\r\n          -  refusal to participate in the study\r\n      ","sponsor":"Dokuz Eylul University","sponsor_type":"Other","conditions":"Breast Cancer Lymphedema","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"28-questionnaire about the use of compression garments","time_frame":"baseline","description":"Patients will be asked to answer our 28-questionnaire about the use of compression garments. Patients who used their garments for the recommended time and manner will be considered as compliant."}]}
{"nct_id":"NCT03763877","start_date":"2019-03-29","phase":"Phase 2","enrollment":120,"brief_title":"A Study of the Efficacy and Safety of PXL770 Versus Placebo After 12 Weeks of Treatment in Patients With NAFLD","official_title":"A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial to Assess the Efficacy and Safety of PXL770 Versus Placebo After 12 Weeks of Treatment in Patients With NAFLD","primary_completion_date":"2020-08-03","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-08-10","last_update":"2020-11-25","description":"This study will assess the efficacy and safety of 3 doses of PXL770 versus placebo after 12 weeks of treatment.","other_id":"PXL770-004","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients have given written informed consent\r\n\r\n          -  Body mass index (BMI)  25 to  50 kg/m\r\n\r\n          -  For patients with type 2 diabetes mellitus: either naive of glucose lowering drug or\r\n             under stable oral glucose lowering drug\r\n\r\n          -  Estimated glomerular filtration rate (eGFR)  60 mL/[min*1.73m]\r\n\r\n          -  Alanine amino transferase (ALT) > 20 IU/L in females and > 30 IU/L in males\r\n\r\n          -  Hepatic steatosis (MRI-PDFF  10%)\r\n\r\n          -  Effective contraception for women of child bearing potential\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Evidence of another form of liver disease\r\n\r\n          -  Evidence of liver cirrhosis\r\n\r\n          -  Evidence of hepatic impairment\r\n\r\n          -  Positive serologic evidence of current infectious liver disease\r\n\r\n          -  History of excessive alcohol intake\r\n\r\n          -  Acute cardiovascular disease with 24 weeks prior to screening\r\n\r\n          -  Uncontrolled high blood pressure\r\n\r\n          -  Any disease which in the Investigator's opinion which in the Investigator's opinion\r\n             would exclude the patient from the study\r\n\r\n          -  Use of non-permitted concomitant medication\r\n\r\n          -  Pregnancy or lactation\r\n      ","sponsor":"Poxel SA","sponsor_type":"Industry","conditions":"Nonalcoholic Fatty Liver","interventions":[{"intervention_type":"Drug","name":"Drug: PXL770","description":"Oral capsule"},{"intervention_type":"Drug","name":"Drug: Placebo oral capsule","description":"Oral capsule"}],"outcomes":[{"outcome_type":"primary","measure":"Change in the percentage of liver fat mass (assessed by MRI-PDFF)","time_frame":"Baseline and Week 12"},{"outcome_type":"secondary","measure":"Change in metabolic parameters","time_frame":"Baseline and Week 12","description":"Lipids parameters: total cholesterol, HDL-c, LDL-c and triglycerides"},{"outcome_type":"secondary","measure":"Change in non-metabolic parameters","time_frame":"Baseline and Week 12","description":"Parameters of inflammation: hsCRP, fibrinogen and MCP-1"},{"outcome_type":"secondary","measure":"Assessment of the safety and tolerability","time_frame":"Baseline to Week 12","description":"Adverse Events"}]}
{"nct_id":"NCT03901872","start_date":"2019-03-29","enrollment":65,"brief_title":"Contemporary Endovascular Therapies in Treatment of Acute Iliofemoral Deep Vein Thrombosis","official_title":"Contemporary Endovascular Therapies in Treatment of Acute Iliofemoral Deep Vein Thrombosis A Prospective, Multicentre Cohort Trial A Physician Initiated Research Study Request","primary_completion_date":"2023-02-28","study_type":"Observational","rec_status":"Recruiting","completion_date":"2023-02-28","last_update":"2019-08-02","description":"The goal of this initial proof of principle single arm cohort trial is to determine if contemporary endovascular venous intervention, compared with a 1:1 propensity-matched medical therapy arm of the ATTRACT trial, significantly reduces the 2-year occurrence of Post Thrombotic Syndrome (PTS) in subjects with symptomatic proximal Deep Vein Thrombosis (DVT).","other_id":"IRAS 254427","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":16,"maximum_age":75,"population":"All acute DVT patients will be screened for entry into the trial","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patient age 16 years to 75 years.\r\n\r\n          -  Onset of acute DVT symptoms of 14 days or less in the study limb.\r\n\r\n          -  DVT located in the common and/or external iliac, or common femoral vein\r\n\r\n          -  Consent to participate in this research study and be willing to commit to study\r\n             requirements including completion of questionnaires and follow-up visits.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  In the index leg: established PTS, or previous symptomatic DVT within the last 2\r\n             years.\r\n\r\n          -  In the contralateral (non-index) leg: symptomatic acute DVT a) involving the iliac\r\n             and/or common femoral vein; or b) for which thrombolysis is planned as part of initial\r\n             therapy.\r\n\r\n          -  Limb-threatening circulatory compromise.\r\n\r\n          -  Pulmonary embolism defined as either massive (Systolic blood pressure < 90 mmHg and/or\r\n             patient on IV vasoactive medication to support blood pressure), or intermediate high\r\n             risk pulmonary embolism (PE), as defined by the European Society Guideline on\r\n             management of PE. Low risk PE and/or intermediate low risk PE can be enrolled.\r\n\r\n          -  Inability to tolerate contemporary venous intervention procedure due to severe dyspnea\r\n             or acute systemic illness.\r\n\r\n          -  Allergy, hypersensitivity, or thrombocytopenia from heparin, Recombinant tissue\r\n             plasminogen activator (rtPA), or iodinated contrast, except for mild-moderate contrast\r\n             allergies for which steroid pre-medication can be used.\r\n\r\n          -  Haemoglobin < 9.0 mg/dl, INR > 1.6 before starting anticoagulation, or platelets <\r\n             100,000/ml. Moderate renal impairment in diabetic patients (estimated glomerular\r\n             filtration rate < 60 ml/min) or severe renal impairment in non-diabetic patients\r\n             (estimated glomerular filtration rate < 30 ml/min).\r\n\r\n          -  Active bleeding, recent (< 3 mo) GI bleeding, severe liver dysfunction, bleeding\r\n             diathesis.\r\n\r\n          -  Recent (< 3 mo) internal eye surgery or haemorrhagic retinopathy; recent (< 10 days)\r\n             major surgery, cataract surgery, trauma, cardiopulmonary resuscitation, obstetrical\r\n             delivery, or other invasive procedure.\r\n\r\n          -  History of stroke or intracranial/intraspinal bleed, tumor, vascular malformation,\r\n             aneurysm.\r\n\r\n          -  Active cancer (metastatic, progressive, or treated within the last 6 months).\r\n             Exception: patients with non-melanoma primary skin cancers are eligible to participate\r\n             in the study.\r\n\r\n          -  Severe hypertension on repeated readings (systolic blood pressure > 180 mmHg or\r\n             diastolic blood pressure > 105 mmHg). This can be treated, and blood pressure must be\r\n             stable before venous access is obtained (systolic blood pressure <140 mmHg).\r\n\r\n          -  Pregnant (positive pregnancy test, women of childbearing potential must be tested).\r\n\r\n          -  Recently (< 1 mo) had thrombolysis or is participating in another investigational\r\n             device or drug study that may convolute study results.\r\n\r\n          -  Life expectancy < 2 years or chronic non-ambulatory status.\r\n\r\n          -  Inability to provide informed consent or to comply with study assessments (e.g. due to\r\n             cognitive impairment or geographic distance).\r\n\r\n          -  Inferior vena cava (IVC) thrombus. Significant thrombus of the IVC, by definition,\r\n             thrombus extending more than one centimeter above the IVC - common iliac vein\r\n             confluence will be a cause for exclusion.\r\n\r\n          -  Inability to obtain access of the enrolled ipsilateral popliteal vein using ultrasound\r\n             guided micro-puncture technique.\r\n\r\n          -  History of, or active heparin induced thrombocytopenia (HIT).\r\n      ","sponsor":"Guy's and St Thomas' NHS Foundation Trust","sponsor_type":"Other","conditions":"Thrombolysis|Deep Vein Thrombosis","interventions":[{"intervention_type":"Device","name":"Device: Contemporary endovascular venous intervention by Zelante pharmacomechanical thrombolysis","description":"All patients will undergo ultrasound guided micro puncture venous access of the enrolled ipsilateral lower extremity popliteal vein followed by a diagnostic venogram to define thrombus burden and anatomic extent of DVT. Prior to and every 30 minutes during the endovascular procedure, an activated clotting time (ACT) will be obtained. Intravenous unfractionated heparin will be administered to keep the ACT between 250 - 300. A Zelante catheter will be utilised to perform pharmacomechanical thrombolysis of the enrolled lower extremity. If there is involvement of the popliteal and/or femoral vein, pharmacomechanical thrombolysis should also be performed of these veins. Venous stenting may be implemented to address areas of residual venous stenosis or outflow obstruction following pharmacomechanical thrombolysis. Stent placement in the common iliac, external iliac, and common femoral vein are routinely done to address inflow or outflow issues after pharmacomechanical thrombolysis."}],"outcomes":[{"outcome_type":"primary","measure":"Rate of Post thrombotic Syndrome at 2 years","time_frame":"2 years"}]}
{"nct_id":"NCT03882866","start_date":"2019-03-28","phase":"N/A","enrollment":220,"brief_title":"Iodine-125 Seed Implantation Therapy for Locally Advanced Pancreatic Cancer","official_title":"3D-printed Template for Iodine-125 Seed Implantation Therapy in Patients With Locally Advanced Pancreatic Cancer: a Multicenter Study","primary_completion_date":"2021-06-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-09-30","last_update":"2020-02-06","description":"This study evaluates the application of 3D-printed template for iodine-125 seed implantation therapy in patients with locally advanced pancreatic cancer. Half of participants will receive 3D-printed coplanar template, while the other half will receive 3D-printed non-coplanar template.","other_id":"2018clinicethicreview215","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age: 18-80 years\r\n\r\n          -  Cytologically or histologically confirmed pancreatic adenocarcinoma\r\n\r\n          -  Inoperable locally advanced pancreatic cancer based on American Joint Committee on\r\n             Cancer (AJCC) staging system (8th ed) (without distant metastasis)\r\n\r\n          -  Single tumor size 6 cm\r\n\r\n          -  Karnofsky performance score KPS60\r\n\r\n          -  Estimated survival 3 months\r\n\r\n          -  Without other several comorbidity\r\n\r\n          -  Participants must have adequate organ function:\r\n\r\n               -  WBC3109/L; HGB90g/dL; PLT50109/L\r\n\r\n               -  Aspartate Transaminase (AST)/alanine aminotransferase ( ALT) 3  institutional\r\n                  upper limit of normal\r\n\r\n               -  Albumin3g/dL\r\n\r\n               -  Total bilirubin 3mg/dL\r\n\r\n               -  PT3  institutional upper limit of normal or INR2.3\r\n\r\n               -  Creatinine 1.5  institutional upper limit of normal\r\n\r\n          -  Ability to understand and the willingness to sign a written informed consent document\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with other malignant tumors\r\n\r\n          -  History of other anti-cancer therapy, including surgery,radiation, ablation and so on\r\n\r\n          -  Pregnant or lactating women\r\n\r\n          -  Patients with Immunodeficiency disease\r\n\r\n          -  Several heart disease, for example: New York Heart Association (NYHA) class III/IV\r\n             congestive heart failureactive coronary heart disease and severe arrhythmia\r\n\r\n          -  Uncontrolled hypertension\r\n\r\n          -  Ongoing or active infection (>grade 2 based on National Cancer Institute-Common\r\n             Terminology Criteria for Adverse Events (NCI-CTCAE) 4.0 edition)\r\n\r\n          -  Active tuberculosis\r\n\r\n          -  Chronic renal insufficiency\r\n\r\n          -  Other organ failure\r\n\r\n          -  History of organ transplantation\r\n\r\n          -  History of severe mental illness\r\n      ","sponsor":"Ruijin Hospital","sponsor_type":"Other","conditions":"Pancreatic Cancer","interventions":[{"intervention_type":"Procedure","name":"Procedure: 3D-printed non-coplanar template","description":"3D-printed non-coplanar template is used in the intervention group. Iodine-125 seed implantation therapy is assisted using 3D-printed non-coplanar template as a guide in patients with locally advanced pancreatic cancer. 3D-printed non-coplanar template is designed and printed according to a preoperative CT scan and treatment planning system."},{"intervention_type":"Procedure","name":"Procedure: 3D-printed coplanar template","description":"3D-printed coplanar template is used in the intervention group. Iodine-125 seed implantation therapy is assisted using 3D-printed coplanar template as a guide in patients with locally advanced pancreatic cancer. 3D-printed coplanar template is designed and printed according to a preoperative CT scan and treatment planning system."}],"outcomes":[{"outcome_type":"primary","measure":"Objective Response Rate (ORR)","time_frame":"24 months","description":"ORR is defined as the proportion of the subjects in the analysis population who have a complete response (CR) or partial response (PR). Responses are based on assessments per RECIST 1.1."},{"outcome_type":"secondary","measure":"Overall Survival (OS)","time_frame":"24 months","description":"OS is defined as the time from randomization to death due to any cause, or censored at date last known alive."},{"outcome_type":"secondary","measure":"Incidence of treatment-emergent toxicities of two treatment regimens in patients","time_frame":"24 months","description":"The toxicity criteria of the Radiation Therapy Oncology Group (RTOG) were applied to assess the acute and late adverse effects of irradiation."},{"outcome_type":"secondary","measure":"Quality of life of two treatment regimens in patients","time_frame":"24 months","description":"Quality of life will be evaluated using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ)C30 Questionnaire."}]}
{"nct_id":"NCT03885531","start_date":"2019-03-27","enrollment":600,"brief_title":"Safety and Performance of JOURNEY II Cruciate Retaining (CR) Total Knee System (TKS)","official_title":"Safety and Performance of JOURNEY II Cruciate Retaining (CR) Total Knee System (TKS): A Retrospective, Multicenter Study","primary_completion_date":"2020-07-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2020-09-30","last_update":"2020-05-05","description":"The objective of this study is to examine the safety and performance of the Journey II CR TKS based on retrospective data.","other_id":"2018.19.KNE.JIICR.RET","observational_model":"Case-Only","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","population":"Rheumatoid arthritis; post-traumatic arthritis, osteoarthritis or degenerative arthritis;\r\n        failed osteotomies or unicompartmental replacement. This system is designed for use in\r\n        patients having primary total knee replacement surgery, where the cruciate ligaments and\r\n        the collateral ligaments remain intact.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subject received primary uni- or bilateral TKA with the Journey II CR TKS for an\r\n             approved indication;\r\n\r\n          -  The TKA occurred at least 12 weeks prior to enrollment\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  None\r\n      ","sponsor":"Smith & Nephew, Inc.","sponsor_type":"Industry","conditions":"Journey II CR Total Knee System","interventions":[{"intervention_type":"Device","name":"Device: Total knee arthroplasty with Journey II CR Total Knee System","description":"TKA with Journey II CR Total Knee System"}],"outcomes":[{"outcome_type":"primary","measure":"Number of adverse events reported per ISO 14155 guidelines","time_frame":"7 years"},{"outcome_type":"secondary","measure":"Length of hospital stay for primary (index) surgery","time_frame":"7 years"},{"outcome_type":"secondary","measure":"Number of hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery","time_frame":"7 years"},{"outcome_type":"secondary","measure":"Length of stay of hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery","time_frame":"upon occurence through 7 years of study duration"},{"outcome_type":"secondary","measure":"Number of rehabilitation sessions","time_frame":"7 years"},{"outcome_type":"secondary","measure":"Duration of rehabilitation sessions in weeks","time_frame":"7 years"},{"outcome_type":"secondary","measure":"Number and type of outpatient visits","time_frame":"7 years"},{"outcome_type":"secondary","measure":"Number of re-operations","time_frame":"7 years"},{"outcome_type":"secondary","measure":"Quality of Life as measured by EQ-5D-3L score","time_frame":"7 years","description":"The EQ-5D-3L will be collected at each follow up visit. It consists of two pages - the EQ-5D descriptive system (page one) and the EQ visual analogue scale (EQ VAS) (page two). The descriptive system consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which takes one of three responses. The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular dimension. The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents."},{"outcome_type":"secondary","measure":"Patient Pain Level as measured by Knee Society Score (KSS)","time_frame":"7 years","description":"Combines an objective physician-derived component with a subjective subject-derived component. The objective section rates alignment, instability, joint motion and symptoms. Patient reported expectations and satisfaction questions evaluate pain relief, functional abilities, satisfaction and fulfillment of expectations using a subjective perspective. A functional score is derived from assessments of walking and standing, standard activities, advanced activities and discretionary activities."},{"outcome_type":"secondary","measure":"Number of days before return to work","time_frame":"7 years"},{"outcome_type":"secondary","measure":"Number of technical difficulties encountered with the device","time_frame":"7 years"}]}
{"nct_id":"NCT04049292","start_date":"2019-03-27","phase":"N/A","enrollment":250,"brief_title":"Better and Safer Return to Sport","official_title":"Better and Safer Return to Sport After Anterior Cruciate Ligament Reconstruction","primary_completion_date":"2024-05-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2024-05-31","last_update":"2021-04-27","description":"A prospective cohort design will be used to assess differences in outcomes between pivoting sport athletes with anterior cruciate ligament reconstruction (ACLR) who follow usual care and those who follow a treatment algorithm with a RTS and rehabilitation tool. Athletes aged 15-40 at injury with primary ACLR who express a goal to return to sports with frequent pivoting are eligible. The RTS and rehabilitation tool includes standardized clinical, functional and muscle strength testing 6, 8, 10, and 12 months after surgery. Individual test results guide progression in sports participation and the content of further rehabilitation according to a standardized algorithm.","other_id":"2018/1886","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":15,"maximum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  primary anterior cruciate ligament reconstruction 6 months ago (+- 2 weeks)\r\n\r\n          -  age 15-40 years at the time of anterior cruciate ligament injury\r\n\r\n          -  preinjury participation in level I pivoting sport at least 2 times per week\r\n\r\n          -  expressed goal to return to level I sport\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  grade 3 injury to the medial collateral ligament, lateral collateral ligament, or\r\n             posterior cruciate ligament\r\n\r\n          -  contralateral ACL tear\r\n\r\n          -  inability to understand the native language in the country of recruitment\r\n\r\n          -  other serious injury or illness that impairs function\r\n\r\n          -  has access to specialist sports medicine care (e.g., health support from national\r\n             team) not accessible to all athletes\r\n\r\n          -  derives primary income from sports participation\r\n\r\n          -  member of sports health team present at the majority of the team's training sessions\r\n      ","sponsor":"Norwegian School of Sport Sciences","sponsor_type":"Other","conditions":"Anterior Cruciate Ligament Injuries|Sport Injury","interventions":[{"intervention_type":"Other","name":"Other: Better and safer return to sport (BEAST)","description":"The RTS assessment includes a Lachman test, modified stroke test, side hop test, triple hop test, and quadriceps muscle power test. The sport-specific progression plans have 6 participation levels in practice and 6 participation levels in match play. A minimum of 2 weeks and 4 training sessions without pain or effusion must be completed before the athlete progresses to the next level. Criteria for full, unrestricted participation in practice: (1)at least 9 months from ACLR, (2)modified stroke test grade 0, (3)completed previous levels in the sport-specific progression plan, (4)negative Lachman test, (5)side hop test limb symmetry at least 90%, (6)triple hop test limb symmetry at least 90%, (7)quadriceps power symmetry at least 90%. The strength training and knee control exercise protocols each have 3-4 different exercises of 3-4 sets that are performed 3 days per week."},{"intervention_type":"Other","name":"Other: Usual care","description":"Usual care is determined by the treating health care professional"}],"outcomes":[{"outcome_type":"primary","measure":"Return to sport","time_frame":"2 years after ACLR","description":"Participation in preinjury sport (yes/no)"},{"outcome_type":"primary","measure":"Reinjury","time_frame":"2 years after ACLR","description":"Injury to the ACL, medial or lateral meniscus in the ipsi- and contralateral knee (yes/no)"},{"outcome_type":"secondary","measure":"International knee documentation committee subjective knee form","time_frame":"2 years after ACLR","description":"Patient-reported measure of knee symptoms, function and activity level, scored 0-100"},{"outcome_type":"secondary","measure":"Anterior cruciate ligament return to sport after injury","time_frame":"2 years after ACLR","description":"Patient-reported measure of emotions, confidence in performance, and risk appraisal in relation to RTS, scored 0-100"},{"outcome_type":"secondary","measure":"Adherence/fidelity to the intervention","time_frame":"Monthly self-report 7-14 months after ACLR","description":"Project-specific questionnaire"},{"outcome_type":"secondary","measure":"Barriers and motivating factors for adherence to the intervention","time_frame":"14 months after ACLR","description":"Self-reported on a project-specific questionnaire"},{"outcome_type":"other","measure":"Sports participation","time_frame":"2 years after ACLR","description":"Self-reported participation in all sports/physical activity"},{"outcome_type":"other","measure":"OSTRC overuse injury questionnaire","time_frame":"2 years after ACLR","description":"Oslo Sport Trauma Research Center overuse injury questionnaire"}]}
{"nct_id":"NCT03834883","start_date":"2019-03-26","phase":"Phase 4","enrollment":40,"brief_title":"Reducing the Risk of Drug-Induced QT Interval Lengthening in Women","official_title":"Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening: Reducing the Risk of Drug-Induced QT Interval Lengthening in Women","primary_completion_date":"2022-06-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-06-30","last_update":"2021-07-01","description":"This research will determine if oral progesterone attenuates drug-induced QT interval lengthening in a) Postmenopausal women 50 years of age or older, and b) Premenopausal women studied during the ovulation phase of the menstrual cycle. This investigation will consist of two concurrent prospective, randomized, double-blind, placebo-controlled crossover-design studies in a) Postmenopausal women, and b) Premenopausal women. Each subject will take progesterone or placebo capsules for 1 week. After a two-week \"washout\" (no progesterone or placebo) each subject will then take the alternative therapy (progesterone or placebo) for 1 week. After 7 days of each treatment, subjects will present to the clinical research center to receive a small dose of the QT interval-lengthening drug ibutilide, and the effect on the QT, J-Tpeak and Tpeak-Tend intervals during the progesterone and placebo phases will be compared","other_id":"1806935117","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Prevention","masking_description":"Quadruple","sampling_method":"","gender":"Female","minimum_age":21,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Postmenopausal women:\r\n\r\n          -  50 years of age or older\r\n\r\n          -  No menstrual periods for 365 days or longer\r\n\r\n        Premenopausal women:\r\n\r\n        - 21-40 years of age\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of breast, uterine or ovarian cancer\r\n\r\n          -  History of hysterectomy and/or ovariectomy\r\n\r\n          -  Weight > 135 kg\r\n\r\n          -  Serum K+ < 3.6 mEq/L;\r\n\r\n          -  Serum Mg2+ < 1.8 mg/dL;\r\n\r\n          -  Hematocrit < 26%;\r\n\r\n          -  Hepatic transaminases > 3x upper limit of normal;\r\n\r\n          -  Baseline Bazett's-corrected QT interval > 450 ms\r\n\r\n          -  Taking hormone replacement therapy\r\n\r\n          -  Diagnosis of heart failure\r\n\r\n          -  Symptoms associated with heart failure:\r\n\r\n               -  Pitting edema > 2+\r\n\r\n               -  Crackles or rales on lung auscultation\r\n\r\n               -  S3 or S4 heart sounds\r\n\r\n               -  Unable to climb at least 2 flights of stairs without becoming short of breath\r\n\r\n          -  Current ECG rhythm of atrial fibrillation or other tachyarrhythmia\r\n\r\n          -  Family or personal history of long-QT syndrome or sudden cardiac death not associated\r\n             with acute myocardial infarction\r\n\r\n          -  Concomitant use of any QTc interval-prolonging drug.\r\n\r\n          -  Permanently paced ventricular rhythm\r\n\r\n          -  Pregnancy\r\n\r\n          -  Using any hormonal contraceptives [oral contraceptives, hormone-secreting intrauterine\r\n             devices (IUDs), hormonal implants]\r\n      ","sponsor":"Indiana University","sponsor_type":"Other","conditions":"Long QT Syndrome|Abnormalities, Drug-Induced","interventions":[{"intervention_type":"Drug","name":"Drug: Progesterone","description":"Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"},{"intervention_type":"Drug","name":"Drug: Ibutilide","description":"Ibutilide 0.003 mg/kg administered to all subjects to moderately lengthen the QT interval"}],"outcomes":[{"outcome_type":"primary","measure":"Baseline (pre-ibutilide) QT-F and QT-Fram intervals","time_frame":"After 7 days of treatment with oral progesterone or placebo, prior to receiving ibutilide","description":"QT intervals will be corrected for heart rate using two methods: the Fridericia method and the Framingham method"},{"outcome_type":"primary","measure":"Maximum post-ibutilide QT-F and QT-Fram intervals","time_frame":"Prior to ibutilide; at 5 minutes into the 10-minute ibutilide infusion; end of infusion; and at 5, 10, 15, 20, 30, and 45 minutes and 1, 2, 4, 6, and 8 hours after the ibutilide infusion","description":"Maximum post-ibutilide QT-F and QT-Fram intervals"},{"outcome_type":"primary","measure":"% change from baseline (pre-ibutilide) in maximum QT-F and QT-Fram intervals","time_frame":"Prior to ibutilide; at 5 minutes into the 10-minute ibutilide infusion; end of infusion; and at 5, 10, 15, 20, 30, and 45 minutes and 1, 2, 4, 6, and 8 hours after the ibutilide infusion","description":"% change from baseline (pre-ibutilide) in maximum QT-F and QT-Fram intervals"},{"outcome_type":"primary","measure":"Area under the QT-F and QT-Fram versus time curves during and for 1 hour following ibutilide infusion","time_frame":"Prior to ibutilide; at 5 minutes into the 10-minute ibutilide infusion; end of infusion; and at 5, 10, 15, 20, 30, and 45 minutes and 1 hour after the ibutilide infusion","description":"Area under the QT-F and QT-Fram versus time curves during and for 1 hour"},{"outcome_type":"primary","measure":"Area under the QT-F and QT-Fram versus time curves during and for 8 hours following ibutilide infusion","time_frame":"Prior to ibutilide; at 5 minutes into the 10-minute ibutilide infusion; end of infusion; and at 5, 10, 15, 20, 30, and 45 minutes and 1, 2, 4, 6, and 8 hours after the ibutilide infusion","description":"Area under the QT-F and QT-Fram versus time curves during and for 8 hours following ibutilide infusion"},{"outcome_type":"secondary","measure":"Baseline (pre-ibutilide) heart rate-corrected J-Tpeak (J-Tpeakc) intervals","time_frame":"After 7 days of treatment with oral progesterone or placebo, prior to receiving ibutilide","description":"Baseline (pre-ibutilide) heart rate-corrected J-Tpeak (J-Tpeakc) intervals"},{"outcome_type":"secondary","measure":"Maximum post-ibutilide J-Tpeakc intervals","time_frame":"Prior to ibutilide; at 5 minutes into the 10-minute ibutilide infusion; end of infusion; and at 5, 10, 15, 20, 30, and 45 minutes and 1, 2, 4, 6, and 8 hours after the ibutilide infusion","description":"Maximum post-ibutilide J-Tpeakc intervals"},{"outcome_type":"secondary","measure":"% change from baseline (pre-ibutilide) in maximum J-Tpeakc intervals","time_frame":"Prior to ibutilide; at 5 minutes into the 10-minute ibutilide infusion; end of infusion; and at 5, 10, 15, 20, 30, and 45 minutes and 1, 2, 4, 6, and 8 hours after the ibutilide infusion","description":"% change from baseline (pre-ibutilide) in maximum J-Tpeakc intervals"},{"outcome_type":"secondary","measure":"Area under the J-Tpeakc versus time curve during and for 1 hour following ibutilide infusion","time_frame":"Prior to ibutilide; at 5 minutes into the 10-minute ibutilide infusion; end of infusion; and at 5, 10, 15, 20, 30, and 45 minutes and 1 hour after the ibutilide infusion","description":"Area under the J-Tpeakc versus time curve during and for 1 hour following"},{"outcome_type":"secondary","measure":"Area under the J-Tpeakc versus time curve during and for 8 hours following ibutilide infusion","time_frame":"Prior to ibutilide; at 5 minutes into the 10-minute ibutilide infusion; end of infusion; and at 5, 10, 15, 20, 30, and 45 minutes and 1, 2, 4, 6, and 8 hours after the ibutilide infusion","description":"Area under the J-Tpeakc versus time curve during and for 8 hours following"},{"outcome_type":"secondary","measure":"Baseline (pre-ibutilide) Tpeak-Tend intervals","time_frame":"After 7 days of treatment with oral progesterone or placebo, prior to receiving ibutilide","description":"Baseline (pre-ibutilide) Tpeak-Tend intervals"},{"outcome_type":"secondary","measure":"Maximum post-ibutilide Tpeak-Tend intervals","time_frame":"Prior to ibutilide; at 5 minutes into the 10-minute ibutilide infusion; end of infusion; and at 5, 10, 15, 20, 30, and 45 minutes and 1, 2, 4, 6, and 8 hours after the ibutilide infusion","description":"Maximum post-ibutilide Tpeak-Tend intervals"},{"outcome_type":"secondary","measure":"% change from baseline (pre-ibutilide) maximum Tpeak-Tend intervals","time_frame":"Prior to ibutilide; at 5 minutes into the 10-minute ibutilide infusion; end of infusion; and at 5, 10, 15, 20, 30, and 45 minutes and 1, 2, 4, 6, and 8 hours after the ibutilide infusion","description":"% change from baseline (pre-ibutilide) maximum Tpeak-Tend intervals"},{"outcome_type":"secondary","measure":"Area under the Tpeak-Tend versus time curves during and for 1 hour following ibutilide infusion","time_frame":"Prior to ibutilide; at 5 minutes into the 10-minute ibutilide infusion; end of infusion; and at 5, 10, 15, 20, 30, and 45 minutes and 1 hour after the ibutilide infusion","description":"Area under the Tpeak-Tend versus time curves during and for 1 hour following ibutilide infusion"},{"outcome_type":"secondary","measure":"Area under the Tpeak-Tend versus time curves during and for 8 hours following ibutilide infusion","time_frame":"Prior to ibutilide; at 5 minutes into the 10-minute ibutilide infusion; end of infusion; and at 5, 10, 15, 20, 30, and 45 minutes and 1, 2, 4, 6, and 8 hours after the ibutilide infusion","description":"Area under the Tpeak-Tend versus time curves during and for 8 hours following ibutilide infusion"},{"outcome_type":"other","measure":"Adverse effects","time_frame":"During the 7 days of treatment with progesterone/placebo and at 5 minutes into the 10-minute ibutilide infusion; end of infusion; and at 5, 10, 15, 20, 30, and 45 minutes and 1, 2, 4, 6, and 8 hours after the ibutilide infusion","description":"Adverse effects fo progesterone, placebo and ibutilide will be assessed"}]}
{"nct_id":"NCT03833635","start_date":"2019-03-22","phase":"N/A","enrollment":100,"brief_title":"Effects of OMT on Premature Physiological Parameters","official_title":"Effects of OMT on Premature Physiological Parameters: a RCT","primary_completion_date":"2019-06-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-09-30","last_update":"2019-03-25","description":"Osteopathic manipulative treatment has been showed to reduce LOS in premature infants. Despite the clinical effectiveness, lack of data and information on the physiological underpinning effects during the treatment has been revealed. The aim of the study is to explore the immediate physiological effects of osteopathic treatment on premature infants","other_id":"COME-01-18","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","maximum_age":0.16667,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  preterm infants\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  congenital/genetic disease\r\n\r\n          -  cardiovascular/neurological disease\r\n      ","sponsor":"Come Collaboration","sponsor_type":"Other","conditions":"Premature Infant|Physiological Stress","interventions":[{"intervention_type":"Other","name":"Other: osteopathic manipulative treatment","description":"OMT will be used to treat premature infants after having performed a manual osteopathic assessment. Techniques used are indirect"},{"intervention_type":"Other","name":"Other: Sham","description":"the sham intervention consists in a stable skin-to-skin contact with the participant"}],"outcomes":[{"outcome_type":"primary","measure":"heart rate","time_frame":"immediate","description":"measure of heart rate"},{"outcome_type":"secondary","measure":"oxygen saturation","time_frame":"immediate","description":"measure of oxygen"}]}
{"nct_id":"NCT03803995","start_date":"2019-03-20","phase":"N/A","enrollment":30,"brief_title":"Mapping and Pacing of the His Bundle for Heart Failure Patients With Left Bundle Branch Block","official_title":"Mapping and Pacing of the His Bundle for Heart Failure Patients With Left Bundle Branch Block","primary_completion_date":"2022-03-20","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-06-20","last_update":"2021-04-05","description":"This is a prospective, single-arm, non-randomized, non-blinded study designed to characterize the locations of His Bundle (HB) pacing that results in correction of electrical dyssynchrony and to characterize morphology and activation time of local intracardiac electrogram (IEGM) with an electro-anatomical mapping system during a device implant procedure and secondarily to assess the efficacy of HB pacing or HB plus LV pacing (when indicated) in correction of electrical dyssynchrony in heart failure patients with left bundle branch block.","other_id":"CRD 969","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patients are undergoing implant of an Abbott pacemaker or CRT device under standard\r\n             indications\r\n\r\n          2. An ECG with a wide QRS complex (>130 ms)\r\n\r\n          3. ECG morphology of typical complete LBBB,\r\n\r\n          4. Patients have heart failure with NYHA Class II-IV symptoms,\r\n\r\n          5. LV EF <50%\r\n\r\n          6. At least 18 years old and not pregnant.\r\n\r\n          7. Must provide written informed consent prior to any clinical investigation related\r\n             procedure.\r\n\r\n          8. Willing to comply with study evaluation requirements\r\n\r\n          9. Female subjects of child-bearing potential are required to have a negative pregnancy\r\n             test done within 7 days prior to the implant procedure per site standard test. Female\r\n             patients of childbearing potential should be instructed to use safe contraception\r\n             (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants,\r\n             transdermal patches hormonal vaginal devices, injections with prolonged release.)\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients have non-specific intraventricular conduction delay or right bundle branch\r\n             block\r\n\r\n          2. Previously implanted cardiac devices with three or more permanent leads\r\n\r\n          3. History of aortic valve repair or replacement\r\n\r\n          4. History of tricuspid valve replacement\r\n\r\n          5. Pregnant or nursing subjects and those who plan pregnancy during the clinical\r\n             investigation follow-up period.\r\n\r\n          6. Recent (< 3 months) myocardial infarction, ablation, electrolyte imbalance, or any\r\n             condition within the last 90 days that would contraindicate for pacemaker or CRT\r\n             implant in the opinion of the investigator\r\n\r\n          7. Presence of other anatomic or comorbid conditions, or other medical, social, or\r\n             psychological conditions that, in the investigator's opinion, could limit the\r\n             subject's ability to participate in the clinical investigation or to comply with\r\n             follow-up requirements, or impact the scientific soundness of the clinical\r\n             investigation results.\r\n      ","sponsor":"Abbott Medical Devices","sponsor_type":"Industry","conditions":"Heart Failure|Left Bundle-Branch Block","interventions":[{"intervention_type":"Procedure","name":"Procedure: Mapping and Pacing the His Bundle","description":"During the device implant procedure, 3D electro-anatomical mapping of the His Bundle region will be performed using EnSite Precision mapping system and Advisor HD Grid mapping catheter. This procedure might be part of the standard-of-care at the participating centers."},{"intervention_type":"Procedure","name":"Procedure: Placing a guidewire in Coronary sinus for measurement of Q-LV during His Bundle pacing or, if needed, for LV pacing","description":"During the device implant procedure, a VisionWire coronary guidewire will also be placed into a branch of coronary sinus (CS), targeting a lateral branch. This guidewire could be used for collecting local left ventricle (LV) activation time (Q-LV) or pacing the LV. This guidewire could also be used to deliver a LV lead at physician's discretion. This procedure might be part of the standard-of-care at the participating centers."}],"outcomes":[{"outcome_type":"primary","measure":"Successful HB pacing sites","time_frame":"At device implant procedure","description":"Collect 3D Locations and electrogram characteristics (morphology and activation time) at the sites where His Bundle (HB) pacing is associated with left bundle recruitment and corrects electrical dyssynchrony at HB pacing implant procedure."},{"outcome_type":"secondary","measure":"Success rate of HB pacing","time_frame":"At device implant procedure","description":"Measure success rate of HB pacing or HB plus Left ventricular (LV) pacing in the correction of electrical dyssynchrony at implant procedure;"},{"outcome_type":"secondary","measure":"Ventricular activation during HB pacing","time_frame":"At device implant procedure","description":"Collect ventricular activation times during HB pacing or HB plus LV pacing as compared with intrinsic rhythm and other pacing configurations at implant procedure;"},{"outcome_type":"secondary","measure":"Echocardiographic measurements of LV ejection fraction","time_frame":"At three-month follow-up","description":"Collect echo measurements of LV ejection fraction at three-month follow-up visit"},{"outcome_type":"secondary","measure":"Echocardiographic measurements of LV end-systolic volume","time_frame":"At three-month follow-up","description":"Collect echo measurements of LV end-systolic volume at three-month follow-up visit"},{"outcome_type":"secondary","measure":"Capture threshold of HB pacing","time_frame":"Implant procedure, up to 3 days after implant procedure, two-week follow-up visit, three-month follow-up visit","description":"Measure capture threshold in volts of HB pacing at implant and at follow-up visits post implant"},{"outcome_type":"secondary","measure":"Lead impedance of HB pacing lead","time_frame":"Implant procedure, up to 3 days after implant procedure, two-week follow-up visit, three-month follow-up visit","description":"Measure lead impedance in ohms of HB pacing lead at implant and at follow-up visits post implant"},{"outcome_type":"secondary","measure":"Sensing amplitude of HB pacing lead","time_frame":"Implant procedure, up to 3 days after implant procedure, two-week follow-up visit, three-month follow-up visit","description":"Measure sensing amplitude in millivolts of HB pacing lead at implant and at follow-up visits post implant"}]}
{"nct_id":"NCT04595435","start_date":"2019-03-19","enrollment":300,"brief_title":"IORT-Breast at MCNH","official_title":"Prospective Registry of Intraoperative Radiation Therapy Using Low Energy X-ray for Breast Cancer at Medical Center, Navicent Health","primary_completion_date":"2024-12-31","study_type":"Observational [Patient Registry]","rec_status":"Recruiting","completion_date":"2029-12-31","last_update":"2020-10-20","description":"Intraoperative Breast Radiation Therapy (IORT-Breast) utilizing the Xoft Axxent Electronic Brachytherapy System (Xoft) has been recently introduced as a treatment option for women 50 years of age and older who have early stage, low risk Invasive Breast Cancer (IBC). Clinical trials have shown IORT to be non-inferior to whole breast radiation, however some concern continues with rates of recurrence and clinical outcomes. Given the recent introduction and continued debate it is an excellent opportunity to observe and monitor outcomes in the patients that are treated at Navicent Health through this prospective, observational registry. The opportunity also permits examination of the participant's thoughts and feeling on Quality of Life and Cosmetic Appearance","other_id":"H1901940","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"Female","minimum_age":55,"population":"Patients treated at Navicent Health who meet eligibility criteria for IORT-Breast or who\r\n        have received IORT-Breast within the previous 6 months","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Signed informed consent and HIPAA authorization\r\n\r\n          -  T1 tumor (less than or equal to 20mm in greatest diameter)\r\n\r\n          -  Unifocal\r\n\r\n          -  Histological Grade 1 or 2\r\n\r\n          -  Node Negative\r\n\r\n          -  ER +ve\r\n\r\n          -  HER-2 -ve\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Previous radiation therapy to the involved breast other than IORT within 6 months\r\n\r\n          -  High grade tumors (Histologic grade 3)\r\n\r\n          -  Her-2 Positive\r\n\r\n          -  Lymphovascular invasion\r\n\r\n          -  Metastatic disease\r\n\r\n          -  close proximity to or involvement of skin\r\n\r\n          -  Multifocal cancer\r\n      ","sponsor":"Navicent Health","sponsor_type":"Other","conditions":"Breast Cancer Female|Early-stage Breast Cancer","interventions":[{"intervention_type":"Procedure","name":"Procedure: Lumpectomy","description":"Removal of lump/tumor from breast utilizing an approach that saves as much breast as possible."},{"intervention_type":"Radiation","name":"Radiation: Intraoperative Radiation Therapy","description":"Delivery of low energy radiation therapy directly at surgical site, immediately removal of lump and tissue prior to final surgical closure"}],"outcomes":[{"outcome_type":"primary","measure":"Rate of recurrence","time_frame":"5 year","description":"To determine rate of recurrence of disease at specific time period"},{"outcome_type":"primary","measure":"Rate of recurrence","time_frame":"10 year","description":"To determine rate of recurrence of disease at specific time period"},{"outcome_type":"secondary","measure":"Acute and late effects","time_frame":"5 years","description":"To determine the rate of acute and late effects of IORT at the treatment site. Periodic review by surgeon and self reports identifying acute and late effects and calculating the rate of incidence for the treated group."},{"outcome_type":"secondary","measure":"Treatment Abandonment","time_frame":"5 years","description":"To determine rate and reason for abandoning procedure after being scheduled for procedure. Calculating the rate of those who were scheduled to receive IORT and then did not receive the treatment as planned and reason why they did not receive the treatment."}]}
{"nct_id":"NCT03410407","start_date":"2019-03-19","enrollment":87,"brief_title":"Central Nervous System (CNS) Involvement in Acute Myeloid Leukemia (AML)","official_title":"Central Nervous System (CNS) Involvement in Acute Myeloid Leukemia (AML): an Observational Retrospective Multicentre Study on Patients Previously Registered in GIMEMA Clinical Trials","primary_completion_date":"2020-11-30","study_type":"Observational","rec_status":"Recruiting","completion_date":"2020-11-30","last_update":"2020-10-14","description":"The present study aims at evaluating the prognostic factors at diagnosis predicting Central Nervous System (CNS) relapse in order to identify a group of patients with higher risk of CNS involvement in which prophylaxis with liposomal Ara-C or other drugs should be indicated.","other_id":"AML1617","observational_model":"Case-Only","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"AML patients previously enrolled in GIMEMA studies for AML treatment","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Signed written informed consent according to ICH/EU/GCP and national local laws (if\r\n             applicable).\r\n\r\n          -  Patients aged 18 years affected by AML according to the FAB criteria, previously\r\n             enrolled in GIMEMA Studies for AML treatment. AML patients with CNS involvement\r\n             defined by the confirmation of leukemic blast cells in the centrifuged cerebrospinal\r\n             fluid (CSF) with the presence of more than five WBCs in the CSF or the detection of a\r\n             CNS granulocytic sarcoma using computed tomography or magnetic resonance imaging.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with acute promyelocytic leukemia (FAB M3 subtype), antecedent haematological\r\n             diseases or therapy-related AML.\r\n      ","sponsor":"Gruppo Italiano Malattie EMatologiche dell'Adulto","sponsor_type":"Other","conditions":"Acute Myeloid Leukemia","interventions":[{"intervention_type":"Other","name":"Other: Observation of CNS involvement","description":"AML patients with CNS involvement defined by the confirmation of leukemic blast cells in the centrifuged cerebrospinal fluid (CSF) with the presence of more than five WBCs in the CSF or the detection of a CNS granulocytic sarcoma using computed tomography or magnetic resonance imaging."}],"outcomes":[{"outcome_type":"primary","measure":"Number of CNS relapses","time_frame":"At 12 months from study start","description":"To estimate the association between biological and clinical characteristic at diagnosis and the occurrence of CNS relapse and to confirm predisposing factors already described in literature (young age, higher level of lactate dehydrogenase; WBC counts at diagnosis, FAB M4 and M5 morphology, chromosome 16 inversion and chromosome 11 abnormality) in AML patients previously registered in GIMEMA Studies and treated according to the GIMEMA AML protocols"},{"outcome_type":"secondary","measure":"Number of patients in complete response","time_frame":"At 12 months from study start","description":"Estimation of the association between presence of CNS involvement at diagnosis and during the course of the disease, in terms of CR rate, Overall Survival (OS) and Disease Free Survival (DFS)."},{"outcome_type":"secondary","measure":"Number of patients alive","time_frame":"At 12 months from study start","description":"Estimation of the association between presence of CNS involvement at diagnosis and during the course of the disease, in terms of CR rate, Overall Survival (OS) and Disease Free Survival (DFS)."}]}
{"nct_id":"NCT03854344","start_date":"2019-03-18","phase":"Phase 4","enrollment":65,"brief_title":"Liposomal Bupivacaine Versus Lidocaine for Skin Graft Donor Site Pain","official_title":"Prospective Study of Liposomal Bupivacaine for Pain Control of Split Thickness Skin Graft Donor Sites","primary_completion_date":"2020-12-19","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-12-31","last_update":"2021-05-12","description":"Donor site pain study comparing post-operative donor site pain and opioid consumption after use of Lidocaine or Liposomal Bupivicaine for split thickness skin graft harvesting in patients with less than 20% TBSA burn wounds and less than %5 Deep partial or full thickness burn wounds.","other_id":"143321","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","intervention_model_description":"randomized pre-operatively to receive either lidocaine or liposomal bupivicaine","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Spanish/English speaking\r\n\r\n          -  <20%TBSA; <5% TBSA deep partial or full thickness burns\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  chronic pain syndrome\r\n\r\n          -  > 20% TBSA burn injury; > 5% TBSA deep partial or full thickness burn\r\n\r\n          -  pregnant\r\n\r\n          -  allergy to lidocaine or other local anesthetics\r\n\r\n          -  burns to anterior thighs\r\n      ","sponsor":"University of Kansas Medical Center","sponsor_type":"Other","conditions":"Pain, Postoperative|Burns","interventions":[{"intervention_type":"Drug","name":"Drug: Lidocaine Hydrochloride","description":"Injected subcutaneously for skin graft harvesting"},{"intervention_type":"Drug","name":"Drug: Liposomal bupivacaine","description":"Injected subcutaneously for skin graft harvesting"}],"outcomes":[{"outcome_type":"primary","measure":"A measurement of post operative pain involving skin graft donor site using visual analog scale (VAS) ranging 0-10, at 8 hours post-operatively","time_frame":"The subject completes a pain assessment at 8 hours post-operatively.","description":"Pain score involving skin graft donor sites are measured using a Visual Analog Scale, which is a horizontal line numbered 0-10, with 10 being the worst pain imaginable and 0 indicating no pain and compare pain scores between donor sites treated with Exparel Vs Lidocaine"},{"outcome_type":"secondary","measure":"Opioid pain medication consumption up to 72 hours post-operatively will be compared between the subjects who are given liposomal bupivacaine (Exparel) and lidocaine at the donor sites","time_frame":"72 hours (3 days) post operatively","description":"Opioid consumption will be measured by converting all opioids given to subjects to morphine equivalents"},{"outcome_type":"secondary","measure":"Pain Scores over 72 hours after surgery","time_frame":"Pain scores associated with skin graft donor site will be assessed using Visual Analog Scale (0-10) at 4,8, 12, 24, 48 and 72 hours after surgery. They will be compared between two groups.","description":"Pain score involving skin graft donor sites are measured using a Visual Analog Scale, which is a horizontal line numbered 0-10, with 10 being the worst pain imaginable and 0 indicating no pain and compare pain scores between donor sites treated with Exparel Vs Lidocaine"}]}
{"nct_id":"NCT04179812","start_date":"2019-03-16","enrollment":210,"brief_title":"Multimodal Modeling of the Knee Joint","official_title":"Multimodal Modeling of the Knee Joint","primary_completion_date":"2021-07-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2021-07-31","last_update":"2021-07-02","description":"The trial will contribute to the development of an innovative algorithm that aims to simplify and improve preoperative knee surgical decision. This will be made by automatically extracting anatomical informations from different images acquired on the patient (scanner, MRI, radiography).","other_id":"KneeMod ( 29BRC18.0235)","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","population":"Targeted patients will be those whose leg image modalities are present in the Brest\r\n        University Hospital database","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients having the 3 modality of images : scanner, MRI, radiography\r\n\r\n          -  Patients having osteoarthritis or knee trauma\r\n\r\n          -  Images showing the articualtion of the knee\r\n\r\n          -  having formulated his non opposition\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Presentation of a partial view of the knee or any view that does not allow a good\r\n             segmentation of the total knee joint.\r\n\r\n          -  Refusal to participate\r\n      ","sponsor":"University Hospital, Brest","sponsor_type":"Other","conditions":"Knee Arthroplasty","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Obtaining a similar knee segmentation for all patient regardless of the input image (MRI, CT or radiography)","time_frame":"Inclusion - Day 0","description":"Creation of an algorithm that will automatically segment and provide the same knee anatomical informations for all patients studied regardless of the input image.\r\nThis multimodal modeling will be carried out via the exploitation of an active model of appearance type algorithm."}]}
{"nct_id":"NCT03989856","start_date":"2019-03-15","phase":"N/A","enrollment":60,"brief_title":"Effect of Laparoscopic Suturing Versus Bipolar Coagulation on Ovarian Reserve in Patients Undergoing Endometriotic Ovarian Cystectomy.","official_title":"Effect of Laparoscopic Suturing Versus Bipolar Coagulation on Ovarian Reserve in Patients Undergoing Endometriotic Ovarian Cystectomy.","primary_completion_date":"2019-09-20","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-09-20","last_update":"2019-06-18","description":"In women undergoing laparoscopic ovarian cystectomy which is less harmfull on the ovarian reserve (electrocoagulation or suturing).","other_id":"123456789","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","intervention_model_description":"The study population comprises females in childbearing period underwent laparoscopic ovarian cystectomy at Ain Shams University Maternity Hospital, Obstetric and Gynecology Department, Faculty of medicine.","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age 18- 45.\r\n\r\n          2. Regular menstrual cycle.\r\n\r\n          3. Unilateral ovarian cyst clinical & us finding as endometriotic cyst.\r\n\r\n          4. C/O of pelvic pain.\r\n\r\n          5. No medications (oral pills & hormonal drugs) in the past 3 monthes before enrollement.\r\n\r\n          6. No evidence of endocrine disorders (DM, Thyroid dysfunction,hyper prolactenemia,\r\n             congenital adrenal hyperplesia, cushing's syndrome or adrenal insufficiency)\r\n\r\n          7. No previous adnexial surgery.\r\n\r\n          8. Pathology diagnosis of excised ovarian tissue (endometriotic cyst)\r\n\r\n          9. Appropriate medical condition for laparoscopic surgery.\r\n\r\n         10. Completely understand the process of the study with written consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. PCO according to Rotterdam criteria.\r\n\r\n          2. Pathological diagnosis of excised ovarian tissue as non endometriotic cyst.\r\n\r\n          3. Previous ovarian surgery.\r\n\r\n          4. Suspected ovarian malignancy.\r\n\r\n          5. Patient whose histopathology showed benign cyst apart from endometrioma.\r\n\r\n          6. Irregular menstrual cycles.\r\n\r\n          7. Post menopausal status.\r\n\r\n          8. Bilateral ovarian cyst.\r\n\r\n          9. AMH < 0.5 ng/ml.\r\n\r\n         10. Premature ovarian failure in family.\r\n      ","sponsor":"Ain Shams University","sponsor_type":"Other","conditions":"Ovary Injury","interventions":[{"intervention_type":"Device","name":"Device: 2-0 polyglican absorbable sutures","description":"The sutures will be performed with intracorporeal knots using 2-0 polyglican absorbable sutures (Vicryl; Ethicon Inc., New Jersey, USA). Suture is performed using needle holders for the closure of ovarian parenchyma and controlling bleeding. Bleeding from ovarian hilus will only resolve by suturing."},{"intervention_type":"Device","name":"Device: Diathermy","description":"bipolar coagulation technique will be used to control significant bleeding (40 W current; Richard Wolf, Germany). I"}],"outcomes":[{"outcome_type":"primary","measure":"Ovarian reserve","time_frame":"3 months","description":"By measuring Anti-mullerian hormone"}]}
{"nct_id":"NCT04832906","start_date":"2019-03-13","phase":"Phase 4","enrollment":70,"brief_title":"UA Versus UAE in Treatment of Fibroids","official_title":"Ulipristal Acetate Therapy Versus Uterine Artery Embolization in Management of Uterine Fibroids","primary_completion_date":"2021-03-13","study_type":"Interventional","rec_status":"Completed","completion_date":"2021-03-13","last_update":"2021-04-06","description":"Study objective: To prove that Ulipristal acetate is an effective line of management for uterine fibroids by causing a significant decline in fibroid volumes resulting in a substantial relief of fibroid-related symptoms, and to compare its results with those of uterine artery embolization. Design: A randomized control trial. Setting: Maternity Hospital, Ain Shams University. Patients: Women with symptomatic uterine fibroids. Interventions: 70 women were randomly assigned to either Ulipristal Acetate (UA) group or uterine artery embolization (UAE) group (35 in each group). Both groups were followed up to detect the decline in fibroid size as well as the improvement of symptoms.","other_id":"FMASU M D 71/2019","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":35,"maximum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Their age should range from 35 to 50 years.\r\n\r\n          -  Their body mass index (BMI) should range from 18 to 35 Kg/m2.\r\n\r\n          -  The presence of one or more symptomatic type 2, 3, 4, 5, or 6 uterine fibroids\r\n             according to the FIGO classification.\r\n\r\n          -  The dominant fibroid diameter should range from 4 to 8 cm as assessed by ultrasound.\r\n\r\n          -  They should not be seeking future fertility.\r\n\r\n          -  They should be refusing any surgical intervention whether myomectomy or hysterectomy.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Post-menopausal status or premature ovarian failure.\r\n\r\n          -  Type 0, 1 and 7 uterine fibroids according to FIGO classification.\r\n\r\n          -  Previous myomectomy or any uterine surgery.\r\n\r\n          -  Previous or ongoing hormonal treatment.\r\n      ","sponsor":"Ain Shams Maternity Hospital","sponsor_type":"Other","conditions":"Uterine Fibroid","interventions":[{"intervention_type":"Drug","name":"Drug: Ulipristal Oral Tablet","description":"A selective progesterone receptor modulator (SPRM), as a medical line of treatment for uterine fibroids. Due to its selective anti-proliferative and pro-apoptotic action, Ulipristal Acetate (UA) is assumed to be effective in reducing abnormal uterine bleeding (AUB) and fibroid size."},{"intervention_type":"Procedure","name":"Procedure: Uterine artery embolization","description":"Selective embolization of uterine arteries bilaterally, using polyvinyl alcohol (PVA) particles administered via a catheter followed by capping with a plug of gelatin sponge. The end point for embolization is to have a static column of contrast in the uterine artery, with only a stump filling when the internal iliac artery was injected."}],"outcomes":[{"outcome_type":"primary","measure":"Decline in dominant fibroid volume (in cubic centimeters).","time_frame":"3 months","description":"measured by transvaginal ultrasound."},{"outcome_type":"secondary","measure":"Relief of abnormal uterine bleeding.","time_frame":"3 months","description":"measured by reduction in Pictorial Blood Loss Assessment Chart Score."},{"outcome_type":"secondary","measure":"Relief of pelvic pain.","time_frame":"3 months","description":"measured by reduction in Visual Analogue Scale Score."},{"outcome_type":"secondary","measure":"Relief of pelvic pressure symptoms.","time_frame":"3 months","description":"Subjective feelings of pelvic pressure symptoms including urinary urgency, and constipation was recorded using a simplified questionnaire containing 2 categories defined as \"absent \"and \"present.\""},{"outcome_type":"secondary","measure":"Adverse effects.","time_frame":"6 months","description":"resulting from either treatment options within the 2 arms of the study."}]}
{"nct_id":"NCT03489707","start_date":"2019-03-12","phase":"N/A","enrollment":400,"brief_title":"The Prevent Anal Cancer Self-Swab Study","official_title":"Annual Anal Sampling Using DNA Screening to Identify Men Who Have Sex With Men at Increased Risk for Anal Cancer","primary_completion_date":"2021-08-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-08-31","last_update":"2021-05-21","description":"The purpose of this research study is to find ways to screen for anal cancer among gay, bisexual, and other men who have sex with men (MSM) and transgender persons. This study will try to find out if persons will do annual anal cancer screening, what factors are associated with repeated screening, and how this affects a person's decision to have high-resolution anoscopy.","other_id":"HSC-MS-17-0635","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Screening","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":25,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Be > 25 years of age\r\n\r\n          -  Sex at birth is male or gender identity is a transgender person\r\n\r\n          -  Acknowledge sex with men in the last 5 years, or identify as gay or bisexual\r\n\r\n          -  Understand and be willing to give informed consent\r\n\r\n          -  Be willing to be randomized and able to comply with the protocol\r\n\r\n          -  Spanish and/or English speakers/readers, and\r\n\r\n          -  HIV+ or HIV-\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Not acknowledge sex with men in the past five years and not identify as gay or\r\n             bisexual\r\n\r\n          -  Use of anticoagulants other than Aspirin or NSAIDS\r\n\r\n          -  Prior diagnosis of anal cancer\r\n\r\n          -  Plans to move within 12 months\r\n\r\n          -  Not Milwaukee metro residents\r\n\r\n          -  Not willing to attend one of the designated study clinics at baseline, or\r\n\r\n          -  Inability to give informed consent\r\n      ","sponsor":"Medical College of Wisconsin","sponsor_type":"Other","conditions":"Anal Cancer","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Home-based human papillomavirus (HPV) DNA screening","description":"Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months."},{"intervention_type":"Behavioral","name":"Behavioral: Clinic-based human papillomavirus (HPV) DNA screening","description":"Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months."}],"outcomes":[{"outcome_type":"primary","measure":"Compliance as assessed by the number of participants who provide specimens for annual anal HPV DNA screening","time_frame":"baseline","description":"Compliance as assessed by the number of participants who provide specimens for annual anal HPV DNA screening"},{"outcome_type":"primary","measure":"Compliance as assessed by the number of participants who provide specimens for annual anal HPV DNA screening","time_frame":"12 months","description":"Compliance as assessed by the number of participants who provide specimens for annual anal HPV DNA screening"},{"outcome_type":"secondary","measure":"Factors associated with annual screening compliance as assessed by the Computer-Assisted Self-Interview (CASI) questionnaire (pre-test)","time_frame":"about a week before the first DNA screening","description":"Factors associated with annual screening compliance as assessed by the Computer-Assisted Self-Interview (CASI) questionnaire (pre-test)"},{"outcome_type":"secondary","measure":"Factors associated with annual screening compliance as assessed by the Computer-Assisted Self-Interview (CASI) questionnaire","time_frame":"about 1 hour after the first DNA screening","description":"Factors associated with annual screening compliance as assessed by the Computer-Assisted Self-Interview (CASI) questionnaire"},{"outcome_type":"secondary","measure":"Factors associated with annual screening compliance as assessed by the Computer-Assisted Self-Interview (CASI) questionnaire","time_frame":"about 1 hour after the 12 month DNA screening","description":"Factors associated with annual screening compliance as assessed by the Computer-Assisted Self-Interview (CASI) questionnaire"},{"outcome_type":"secondary","measure":"Factors associated with annual screening compliance as assessed by the Computer-Assisted Self-Interview (CASI) questionnaire","time_frame":"about 1 hour after the HRA (HRA occurs about 2 weeks after the 12-month DNA screening)","description":"Factors associated with HRA compliance as assessed by the Computer-Assisted Self-Interview (CASI)"},{"outcome_type":"secondary","measure":"Number of participants who agree to have a high resolution anoscopy (HRA)","time_frame":"2 weeks after the 12-month DNA screening","description":"Number of participants who agree to have a high resolution anoscopy (HRA)"},{"outcome_type":"other","measure":"Human papillomavirus (HPV) DNA persistence and its association with high-grade squamous intraepithelial lesions.","time_frame":"12 months","description":"Human papillomavirus (HPV) DNA persistence and its association with high-grade squamous intraepithelial lesions: The presence of high-risk HPV (human papillomavirus) DNA will be assessed at baseline and at 12 months. High-risk HPV types that are present at both time points determines the presence of persistence of high-risk HPV DNA. HPV DNA persistence will be assessed for its association with high-grade squamous intraepithelial lesions."},{"outcome_type":"other","measure":"Host/viral methylation and its association with high-grade squamous intraepithelial lesions.","time_frame":"12 months","description":"Host/viral methylation and its association with high-grade squamous intraepithelial lesions: The presence of host/viral methylation patterns will be assessed at baseline and at 12 months. Methylation patterns that are present at either time point will be assessed for its association with high-grade squamous intraepithelial lesions."}]}
{"nct_id":"NCT03902600","start_date":"2019-03-12","enrollment":115,"brief_title":"Moderately Hypofractionated Photon and Proton Chemoradiotherapy as Definitive or Neoadjuvant Therapy in Non-metastatic Pancreas Cancer With Assessment of Treatment Response Utilizing Molecular Biomarkers","official_title":"Moderately Hypofractionated Photon and Proton Chemoradiotherapy as Definitive or Neoadjuvant Therapy in Non-metastatic Pancreas Cancer With Assessment of Treatment Response Utilizing Molecular Biomarkers","primary_completion_date":"2022-05-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2023-03-31","last_update":"2020-11-03","description":"This study will observe side effects for patients who receive a 3-week course of radiation and chemotherapy for pancreas cancer. Blood samples will be collected before and after treatment to assess pancreas cancer DNA levels and its impact on outcomes.","other_id":"17-011198","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Adult patients with pancreatic cancer","criteria":"\n        Inclusion Criteria: -Age  18 years\r\n\r\n          -  Histological confirmation of adenocarcinoma of the pancreas (head, body, or tail of\r\n             pancreas)\r\n\r\n          -  Imaging consistent with T1-4, N0-2, M0 pancreas cancer, including potentially\r\n             resectable, boarderline resectable, or unresectable disease as per NCCN\r\n             classification. When CT of the chest, abdomen, and pelvis are performed, this must be\r\n             with contras per pancreas protocol. Imagining with a PET/MRI alone is acceptable on\r\n             study. If a PET/CT is performed, a separate pancreas protocol CT is required for\r\n             inclusion.\r\n\r\n          -  Must have received neoadjuvant chemotherapy at the discretion of medical oncology\r\n\r\n          -  Medical oncology consultation to confirm that patient is an appropriate candidate for\r\n             concurrent chemotherapy and surgical oncology consultation for confirmation of\r\n             resection status.\r\n\r\n        Note: Patients who have received previous chemotherapy for pancreatic cancer are allowed to\r\n        participate in this study, unless they experienced a previous allergic reaction to the\r\n        drugs used in this study.\r\n\r\n          -  Planned to receive CRT, consisting of PBT or IMRT (45 Gy/15 fractions) with concurrent\r\n             chemotherapy with 5FU or Capecitabine.\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 or Karnofsky\r\n             Performance Status 70-100 (Appendix III).\r\n\r\n          -  Willing to sign consent onto the Mayo Clinic Radiotherapy Patient Outcomes Registry\r\n             and Biobanking study, IRB 15-000136\r\n\r\n          -  Patients do not need to agree to Biobank blood draw.\r\n\r\n          -  Patients at Mayo Clinic Arizona are not required to consent to the Registry.\r\n\r\n          -  Willing to sign consent for blood collection onto the Pancreas SPORE, IRB 354-06.\r\n\r\n          -  Able to complete standard of care clinical questionnaire(s) by themselves or with\r\n             assistance.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Presence of non-regional nodal involvement or distant metastatic disease (M1)\r\n\r\n          -  Prior RT to the thorax, abdomen, or pelvis\r\n\r\n          -  History of prior malignancy < 2 years of enrollment, except non-melanotic skin cancer\r\n             or carcinoma-in-situ of the cervix\r\n\r\n          -  Immunocompromised patients and patients known to be HIV positive and not currently\r\n             receiving antiretroviral therapy.\r\n\r\n        Note: Patients known to be HIV positive, but without clinical evidence of an\r\n        immunocompromised state, are eligible for this trial.\r\n\r\n          -  Receiving any investigational agent concurrent with CRT which would be considered as a\r\n             treatment for the primary neoplasm.\r\n\r\n          -  Any of the following because this study involves an agent that has known genotoxic,\r\n             mutagenic and teratogenic effects:\r\n\r\n               -  Pregnant women\r\n\r\n               -  Nursing women\r\n\r\n               -  Men or women of childbearing potential who are unwilling to employ adequate\r\n                  contraception\r\n\r\n          -  Co-morbid systemic or psychiatric illnesses or other severe concurrent disease which,\r\n             in the judgment of the investigator, would make the patient inappropriate for entry\r\n             into this study or interfere significantly with the proper assessment of safety and\r\n             toxicity of the prescribed regimens.\r\n\r\n          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active\r\n             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac\r\n             arrhythmia, or psychiatric illness/social situations that would limit compliance with\r\n             study requirements.\r\n      ","sponsor":"Mayo Clinic","sponsor_type":"Other","conditions":"Pancreatic Cancer","interventions":[{"intervention_type":"Radiation","name":"Radiation: Moderately Hypofractionated RT","description":"Patients will be treated with moderately hypofractionated radiation treatment"}],"outcomes":[{"outcome_type":"primary","measure":"Acute grade 3 or higher GI AEs","time_frame":"2 years after CRT","description":"acute grade 3 or higher GI AEs attributable to hypofractionated concurrent chemoradiotherapy (CRT)"},{"outcome_type":"secondary","measure":"late grade 3 or higher GI AEs","time_frame":"2 years after CRT","description":"ate grade 3 or higher GI AEs attributable to hypofractionated concurrent CRT"},{"outcome_type":"secondary","measure":"local-regional recurrence","time_frame":"2 years after CRT","description":"local-regional recurrence"},{"outcome_type":"secondary","measure":"progression free survival (PFS)","time_frame":"2 years after CRT","description":"progression free survival (PFS)"},{"outcome_type":"secondary","measure":"overall survival","time_frame":"2 years after CRT or until death","description":"overall survival"}]}
{"nct_id":"NCT04403191","start_date":"2019-03-10","enrollment":240,"brief_title":"Usage of Multiple Drugs in Treatment of Postoperative Vomiting After Laparoscopic Appendectomy","official_title":"Comparative Study Between Ondansetron, Isopropyl Alcohol Inhalation and Super Hydration in Treatment of Postoperative Emesis After Laparoscopic Appendectomy","primary_completion_date":"2020-02-04","study_type":"Observational [Patient Registry]","rec_status":"Completed","completion_date":"2020-02-10","last_update":"2020-05-28","description":"To compare and evaluate the antiemetic effect and the safety of ondansetron, inhalational isopropyl alcohol and super hydration on adult patients after laparoscopic appendectomy.","other_id":"ICU-10-20","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":65,"population":"240 patients admitted to surgical I.C.U of King Abdul-Aziz specialist hospital for\r\n        post-operative care after laparoscopic appendectomy surgery between March 2019 till\r\n        February 2020. A Koivuranta Score to Predict Postoperative Nausea and Vomiting done\r\n        preoperatively for all the patients and only those who had score of more than 3 on\r\n        Koivuranta vomiting score (had more than 60% chance to develop PONV) enrolled in our study.\r\n        And randomly allocated in one of three groups group A, B or C.","criteria":"\n        Inclusion Criteria:\r\n\r\n        postoperative nausea and vomiting\r\n\r\n        Exclusion Criteria:\r\n\r\n        systemic disease as diabetes or hypertension local gastric diseases\r\n      ","sponsor":"King Abdul Aziz Specialist Hospital","sponsor_type":"Other","conditions":"to Treat the Vomiting Frequently Occur Post-laparoscopic by Different Anti Emetic Drugs","interventions":[{"intervention_type":"Drug","name":"Drug: Ondansetron","description":"ondansetron 4 mg intravenous immediately once reached to I.C.U and another same dose after 6 hours while patients of group"},{"intervention_type":"Drug","name":"Drug: isopropyl alcohol 70% inhalation","description":"inhalation every 15 min for 4 times then repeated after 6 hours"},{"intervention_type":"Procedure","name":"Procedure: laparoscopic appendectomy","description":"all patients received post operatively after laparoscopic appenectomy"}],"outcomes":[{"outcome_type":"primary","measure":"numbers of vomiting attacks","time_frame":"for one day","description":"numbers of vomiting attacks recorded every 15 minutes for one day"}]}
{"nct_id":"NCT03906786","start_date":"2019-03-07","phase":"N/A","enrollment":60,"brief_title":"Motivational Interviewing and Self-care in Type 1 Diabetes: Randomized Controlled Clinical Trial.","official_title":"Motivational Interviewing and Self-care in Type 1 Diabetes: Randomized Controlled Clinical Trial.","primary_completion_date":"2020-09-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2020-09-30","last_update":"2019-04-08","description":"Type 1 diabetes requires a high level of involvement of patients to obtain good control by following complex therapeutic recommendations. Motivational Interviewing has proven to be effective in changing behaviors in sedentary people, with addictions and with obesity. Our objective is to evaluate the impact of an intervention with Motivational Interviewing in patients with type 1 diabetes, through a randomized controlled clinical trial. At least sixty patients with type 1 diabetes will be included with HbA1c> 8% that will be randomized with a ratio of 1: 1. In the intervention group, Motivational Interviewing will be applied in the routine clinical appointments with the Endocrinologist, while the control group will receive the same visits but in a traditional way. The primary result will be self-care behaviors according to a validated questionnaire. Secondary outcomes include: HbA1c, number of hypoglycemia, motivation with self-care, self-efficacy, quality of life, compliance with patients' own objectives, lipid profile, weight and blood pressure. The professionals will be trained in Motivational Interviewing with the objective of favoring the adherence to self-care, the motivation of the patient and improving doctor-patient relationship. They will also be evaluated through a specific questionnaire.","other_id":"CEIm-CHUIMI-2017/974","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with DM1 seen in outpatient clinics of Endocrinology and Nutrition with at\r\n             least one year of evolution, HbA1c> 8% and / or severe hypoglycemia in the previous 6\r\n             months\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Gestion underway or scheduled for the next 9 months. Any circumstance that, in the\r\n             opinion of the investigators, could interfere with the follow-up of the patient.\r\n      ","sponsor":"Hospital Universitario Insular Gran Canaria","sponsor_type":"Other","conditions":"Type1diabetes","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: motivational interviewing","description":"The intervention will consist of 4 structured medical consultations in the form of a motivational interviewing compared to usual care, covering a 12-month intervention period. In both groups, the frequency of visits (c / 3 months) and the variables collected will be the same."}],"outcomes":[{"outcome_type":"primary","measure":"Adherence to self-care behaviors. The Diabetes Self-Care Inventory-Revised","time_frame":"12 months","description":"The validated Spanish version of The Diabetes Self-Care Inventory-Revised version (SCI-R) (18) was used. This inventory consists of 15 items that refer to self-care behaviors in the treatment of diabetes, which are scored on a Likert scale ranging from (1 = \"never\" to 5 = \"always\"). The scores are converted with a formula and the responses range from 0-100; higher scores indicate higher levels of self-care"}]}
{"nct_id":"NCT03722992","start_date":"2019-03-07","phase":"N/A","enrollment":14,"brief_title":"The Effects of Mindfulness-based Stress Reduction in Interstitial Cystitis Patients","official_title":"The Effects of Mindfulness-based Stress Reduction on the Urinary Microbiome in Patients With Interstitial Cystitis/Painful Bladder Syndrome","primary_completion_date":"2020-01-15","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-03-15","last_update":"2020-07-23","description":"This is a prospective cohort study to investigate differences in the bladder environment (i.e. urinary microbiome) amongst women with interstitial cystitis (IC) before and after undergoing mindfulness-based stress reduction (MBSR) treatment, including yoga and meditation practices.","other_id":"18-056","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adults 18 years of age or older\r\n\r\n          -  English-speaking\r\n\r\n          -  Established patient of Cincinnati Urogynecology Associates, TriHealth Inc.\r\n\r\n          -  Current diagnosis of IC/PBS, as defined by the American Urological Association (AUA)\r\n\r\n          -  Negative urinalysis or urine culture within 2 months of enrollment\r\n\r\n          -  Currently undergoing first or second-line treatment for IC, as defined by the AUA\r\n\r\n          -  Willingness to participate in study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Non-English speaking\r\n\r\n          -  Unwillingness to participate in study\r\n\r\n          -  Pregnancy or breastfeeding\r\n\r\n          -  Physical or mental impairment that would affect the subject's ability to participate\r\n             in the MBSR treatment, including patients with Dementia, Parkinsonism, or those who\r\n             have impaired mobility or hearing\r\n\r\n          -  Current or expected prolonged catheterization\r\n\r\n          -  Expected travel or surgery that would hinder the ability to attend all eight MBSR\r\n             sessions\r\n\r\n          -  Undergoing third-, fourth-, fifth-, or sixth-line treatment for IC as defined by the\r\n             AUA\r\n\r\n          -  Subjects on antibiotics currently or prior use within one week of consenting\r\n      ","sponsor":"TriHealth Inc.","sponsor_type":"Other","conditions":"Interstitial Cystitis","interventions":[{"intervention_type":"Other","name":"Other: MBSR","description":"Guided yoga and meditation practices"}],"outcomes":[{"outcome_type":"primary","measure":"Difference in the urinary microbiome before and after MBSR treatment","time_frame":"Before intervention and after completion of the intervention, up to 9 weeks","description":"Urinary microbiome sequencing analysis will be performed by Resphera Biosciences Laboratory"}]}
{"nct_id":"NCT04167306","start_date":"2019-03-04","phase":"Phase 2","enrollment":380,"brief_title":"Varenicline and Bupropion for Alcohol Use Disorder","official_title":"A Randomized, Double-blind, Placebo-controlled Multicenter Trial on the Efficacy of Varenicline and Bupropion in Combination and Alone, for Treatment of Alcohol Use Disorder","primary_completion_date":"2022-12-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-12-30","last_update":"2019-11-29","description":"The COMB study is a randomized double-blind placebo-controlled multicenter trial in Sweden on the efficacy of varenicline and bupropion, in combination and alone, for treatment of alcohol use disorder (AUD). Study design overview: A 13-weeks (91 days) multicenter clinical trial with four parallel groups. 95 subjects per treatment arm will be randomized into the study. 380 subjects with AUD will be randomized in total.","other_id":"COMB-BO8","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":25,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Signed informed consent\r\n\r\n          2. Blood alcohol level below <0.1 (0.1 g/L) at signing informed consent\r\n\r\n          3. 25-70 years of age at screening\r\n\r\n          4. Moderate and severe AUD according to DSM-V (meeting 4 out of 11 criteria)\r\n\r\n          5. B-PEth levels of 0.5 mol/L at screening visit (visit 1)\r\n\r\n          6. Continuous high alcohol consumption over the last 3 months prior to screening as\r\n             defined by at least 2 HDD per week on a typical week\r\n\r\n          7. Available phone number for contact\r\n\r\n          8. Ability to speak and write in Swedish\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Total abstinence between screening and randomization visit\r\n\r\n          2. Treatment of alcohol withdrawal within 30 days of study initiation\r\n\r\n          3. Pharmacological treatment within 3 months of study initiation and during the study\r\n             period that may affect alcohol consumption, including but not exclusive to,\r\n             varenicline, bupropion, disulfiram, acamprosate, naltrexone, nalmefene, baclofen,\r\n             topiramate, ondansetron, mirtazapine, methylphenidate, dexamphetamine, atomoxetine,\r\n             pregabalin, buprenorphine and methadone\r\n\r\n          4. Non-pharmacological treatment within 3 months of study initiation and during the study\r\n             period that may affect alcohol consumption\r\n\r\n          5. Current continuous use of antidepressants, opioid analgesics, benzodiazepines,\r\n             zopiclone, zolpidem, hydroxyzine, alimemazine, propiomazine, or other sedatives. (The\r\n             sporadic use of these compounds is accepted.)\r\n\r\n          6. Any concurrent medication that may affect the results of the trial or is considered to\r\n             compromise the safety of the participants in the trial. (See SmPCs for possible\r\n             interactions.)\r\n\r\n          7. Laboratory hepatic values of >3 times the upper limit of the normal range, creatinine\r\n             clearance <30 ml/min, or other clinically significant abnormalities in the screening\r\n             laboratory values\r\n\r\n          8. Blood pressure 180/110 at screening\r\n\r\n          9. Pregnancy, breast-feeding and for premenopausal women, not using one of the\r\n             contraceptive methods oral contraceptive, intrauterine contraceptive device (copper or\r\n             hormonal) or subcutaneous inplant.\r\n\r\n         10. Diabetes mellitus type 1 and diabetes mellitus type 2 in need of insulin treatment\r\n\r\n         11. Any current psychiatric or somatic disorder or condition that may affect assessments\r\n             or compromise participant's safety during the trial\r\n\r\n         12. ASRS- v1.1, part A score 4 in the marked cut-off section\r\n\r\n         13. MADRS score  20\r\n\r\n         14. Current depression that is not mild (mild depression is accepted)\r\n\r\n         15. Suicidality\r\n\r\n         16. Current illicit drug use based on urine-toxicity test and DUDIT\r\n\r\n         17. History of delirium tremens or abstinence-induced seizures within 5 years of study\r\n             initiation\r\n\r\n         18. Epilepsy or seizures other than alcohol-induced, lifetime\r\n\r\n         19. Severe sleep disturbances\r\n\r\n         20. Need of alcohol detoxification\r\n\r\n         21. Living conditions not appropriate to fulfil study requirements\r\n\r\n         22. Use of herbal drugs/tea and supplementations possibly affecting outcome or safety\r\n\r\n         23. Previous randomization in this trial or participation in another trial within 3 months\r\n             of enrollment into this trial.\r\n\r\n         24. Additional factors that render the participant unable to complete the study, as judged\r\n             by the investigator\r\n      ","sponsor":"Vastra Gotaland Region","sponsor_type":"Other","conditions":"Alcohol Use Disorder|Alcoholism|Alcohol Dependence","interventions":[{"intervention_type":"Drug","name":"Drug: Varenicline Tartrate 1 mg b.i.d","description":"Capsules for oral use"},{"intervention_type":"Drug","name":"Drug: Bupropion Hydrochloride 150 mg b.i.d","description":"Capsules for oral use"},{"intervention_type":"Other","name":"Other: Placebo for varenicline","description":"Capsules for oral use"},{"intervention_type":"Other","name":"Other: Placebo for bupropion","description":"Capsules for oral use"}],"outcomes":[{"outcome_type":"secondary","measure":"Self-reported alcohol consumption measured by time-lime-follow-back","time_frame":"CDT is calculated as the mean value over the active steady state period (Day 21-Day77) compared to baseline (=screening visit value)","description":"Mean grams of alcohol per day\r\nNumber of drinking days\r\nNumber of drinks per drinking days\r\nNumber of abstaining days"},{"outcome_type":"primary","measure":"Alcohol consumption as measured by phosphatidylethanol (PEth) in blood","time_frame":"PEth is calculated as the mean value over the active steady state period (Day 21-Day77) compared to baseline (=screening visit value)","description":"B-PEth: Objective marker for alcohol consumption measured in blood,measured at every study visit"},{"outcome_type":"primary","measure":"Alcohol consumption as measured by heavy drinking days (HDD)","time_frame":"Number of HDD by 14 days is defined as a mean over the 8-week steady state active treatment period (Day 21-Day77) . ( D21-D77)/4 in order to get a 14 day-period measurment.","description":"HDD is obtained by the time Line Follow Back procedure, defined in two ways; as ≥60 grams for men and ≥40 for women according to EMA's guideline and as ≥70 grams for men and ≥56 grams for women according to FDA's guidelines"},{"outcome_type":"secondary","measure":"CDT","time_frame":"CDT is calculated as the mean value over the active steady state period (Day 21-Day77) compared to baseline (=screening visit value)","description":"The indirect alcohol marker carbohydrate deficient transferrin"},{"outcome_type":"secondary","measure":"GGT","time_frame":"GGT calculated as the mean value over the active steady state period (Day 21-Day77) compared to baseline (=screening visit value)","description":"The indirect alcohol marker gamma glutamyl transferase"},{"outcome_type":"secondary","measure":"Alcohol Use Identification Test","time_frame":"Mean difference between total score obtained at baseline and visit 1","description":"Total score of Alcohol Use Identification Test"},{"outcome_type":"secondary","measure":"Self-reported Alcohol Craving","time_frame":"Scale range: 0-100 mm. Minimum value: 0 = No craving. Maxumum value: 100 Maximum= Very strong craving. Craving is calculated as the mean value over the active steady state period (Day 21-Day77) compared to baseline (=screening visit value)","description":"Alcohol craving as measured by a Visual Analogue Scale (VAS)"},{"outcome_type":"secondary","measure":"Nicotine use","time_frame":"77 day-interval. Mean difference between cotinine concentration assessed at Day o and Day 77","description":"Nicotine use measured by the nicotine saliva marker cotinine in saliva"},{"outcome_type":"secondary","measure":"The Temporal Experience of Pleasure Scale (TEPS)","time_frame":"77 day-interval. Mean difference between total scale score assessed at Day 0 and Day 77","description":"A 17-item scale with anticipatory and consummatory components of the experience of pleasure. The scale is used as a proxy to assess a hypodopaminergic state. Worse Outcome: A lower score indicates low experience of pleasure (=proxy for hypodopaminergic state). Better outcome:A high score indicates high experience of pleasure."},{"outcome_type":"secondary","measure":"The Continous Performance Test + Activity test","time_frame":"77 day-interval. Mean difference between outcome measure assessed at Day o and Day 7.","description":"A neuropsychiatric tool addressing inattention, impulsivity and activity"},{"outcome_type":"secondary","measure":"Plasma concentration of varenicline (ng/ml)","time_frame":"14 day-interval. Obtained twice, at Day 21 and Day 49 during IMP steady state. Correlation between plasma concentration of varenicline and above described outcome measures","description":"Mean concentration of values obtained at visit 4 and visit 6"},{"outcome_type":"secondary","measure":"Plasma concentration of bupropion (ng/ml)","time_frame":"14 day-interval. Obtained twice, at Day 21 and Day 49 during IMP steady state. Correlation between plasma concentration of bupropion and above described outcome measures","description":"Mean concentration of values obtained at visit 4 and visit 6"}]}
{"nct_id":"NCT03810053","start_date":"2019-03-01","phase":"N/A","enrollment":290,"brief_title":"Utilizing Technology to Promote Cancer Prevention","official_title":"Utilizing Technology to Promote Cancer Prevention","primary_completion_date":"2019-12-20","study_type":"Interventional","rec_status":"Completed","completion_date":"2021-07-14","last_update":"2021-09-22","description":"The goal of the program is to develop an online module/a health application for cell phones which will share didactic information regarding cancer prevention and early detection measures. These module/application will be developed, and be tested among volunteers for feedback. In the future, these module/application will be disseminated widely to address cancer health disparity particularly in Arkansas.","other_id":"228815","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Health Services Research","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Any ARResearch volunteer\r\n\r\n          -  18 years or older in age\r\n\r\n          -  Have access to a personal cell phone and/or computer\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Unable to give an informed consent.\r\n      ","sponsor":"University of Arkansas","sponsor_type":"Other","conditions":"Health Knowledge, Attitudes, Practice","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Mobile App/Online Module","description":"Short didactic explainer video that will provide information about cancers and benefits of uptake of cancer prevention and early detection measures."}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants to Learn New Information","time_frame":"up to 6 Months","description":"Percentage of participants that indicated they learned something new about cancer prevention measures."},{"outcome_type":"primary","measure":"Number of Participants to Identify Needed Interventions","time_frame":"up to 6 months","description":"Percentage of participants that identified interventions that they have not yet adopted from the use of the health application."}]}
{"nct_id":"NCT03739567","start_date":"2019-03-01","enrollment":200,"brief_title":"Postoperative Pain in Children Aged From 3 to 5 Years Following Full Mouth Dental Rehabilitation Under General Anesthesia. A Cross-sectional Study. Rehabilitation Under General Anesthesia","official_title":"Postoperative Pain in Children Aged From 3 to 5 Years Following Full Mouth Dental Rehabilitation Under General Anesthesia","primary_completion_date":"2019-03-01","study_type":"Observational","rec_status":"Unknown status","completion_date":"2019-06-01","last_update":"2019-03-05","description":"the purpose of this study is monitoring Postoperative pain in Children Aged from 3 to 5 years following Full mouth Dental Rehabilitation under General Anesthesia","other_id":"CEBD-CU-2018-11-08","observational_model":"Case-Only","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":3,"maximum_age":5,"population":"All children attending the outpatients' clinic of pediatric Dentistry and Public Health\r\n        Faculty of Dentistry Cairo University-Egypt in the period of three months. (With average 30\r\n        patients in week ).","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Egyptian dental children undergoing full mouth dental rehabilitation under general\r\n             anesthesia (3-5 years old )\r\n\r\n          -  Children selected from pediatric dentistry and dental public health department Faculty\r\n             of dentistry Cairo University\r\n\r\n          -  Children with no developmental delay.\r\n\r\n          -  Children with normal physical status.\r\n\r\n          -  Parents who can be communicated well\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Parents refusing participation in the study.\r\n\r\n          -  Parents who cannot be communicated well\r\n\r\n          -  Children with developmental abnormalities\r\n      ","sponsor":"Cairo University","sponsor_type":"Other","conditions":"Post-operative Pain","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Dental Discomfort Questionnaire","time_frame":"3 monthes","description":"Numerical Rating Pain Scale (Outcome measuring device)"}]}
{"nct_id":"NCT03888612","start_date":"2019-03-01","phase":"Phase 1/Phase 2","enrollment":150,"brief_title":"Trial of ARV-110 in Patients With Metastatic Castration Resistant Prostate Cancer","official_title":"A Phase 1/2, Open-label, Dose Escalation, and Cohort Expansion Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARV-110 in Patients With Metastatic Castration Resistant Prostate Cancer","primary_completion_date":"2022-10-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-04-30","last_update":"2021-06-25","description":"Phase 1/2 dose escalation study to assess the safety and tolerability of ARV-110 in men with mCRPC who have progressed on prior approved systemic therapies for their castrate resistant disease (one of which must be enzalutamide or abiraterone).","other_id":"ARV-110-mCRPC-101","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Part A:\r\n\r\n          -  Patients must be male and at least 18 years of age at the time of signing the informed\r\n             consent.\r\n\r\n          -  Patients must present with histological, pathological, or cytological confirmed\r\n             diagnosis of advanced or metastatic castration resistant adenocarcinoma of the\r\n             prostate.\r\n\r\n          -  Patients must have progressed on at least 2 prior approved systemic therapies for CRPC\r\n             (at least one must be abiraterone or enzalutamide).\r\n\r\n          -  Patients with progressive mCRPC\r\n\r\n          -  Patients must have ongoing ADT with a gonadotropin releasing hormone analog or\r\n             inhibitor, or orchiectomy (surgical or medical castration).\r\n\r\n        Part B:\r\n\r\n          -  Patients must be male and at least 18 years of age at the time of signing the informed\r\n             consent.\r\n\r\n          -  Patients must present with histological, pathological, or cytological confirmed\r\n             diagnosis of advanced or metastatic castration resistant adenocarcinoma of the\r\n             prostate.\r\n\r\n          -  Patients must have received at least one but no more than two prior second generation\r\n             anti-androgen agents (e.g., enzalutamide or abiraterone) for CRPC.\r\n\r\n          -  Patients must have received no more than one prior chemotherapy regimen in each of the\r\n             following settings: castrate sensitive and castrate resistant prostate cancer.\r\n\r\n          -  Patients must have ongoing ADT with a gonadotropin releasing hormone analog or\r\n             inhibitor, or orchiectomy (surgical or medical castration).\r\n\r\n        Part B - Phase 2 Expansion Cohort Subgroup 4\r\n\r\n          -  Patient has received only one prior AR second generation therapy (e.g., abiraterone or\r\n             enzalutamide) either as treatment for CSPC or CRPC and no more than 1 regimen in CRPC\r\n             setting.\r\n\r\n          -  No prior chemotherapy\r\n\r\n        Exclusion Criteria:\r\n\r\n        Part A:\r\n\r\n          -  Patients with known symptomatic brain metastases requiring steroids (above physiologic\r\n             replacement doses)\r\n\r\n          -  Major surgery (as defined by the Investigator) within 4 weeks of first dose of study\r\n             drug.\r\n\r\n          -  Radiation therapy within 4 weeks of first dose of study drug or prior irradiation to\r\n             >25% of the bone marrow. Palliative radiation for the alleviation of pain due to bone\r\n             metastasis will be allowed during the study\r\n\r\n          -  Systemic anti cancer therapy within 2 weeks of first dose of study drug (6 weeks for\r\n             bicalutamide, mitomycin C, or nitrosoureas and 4 weeks for abiraterone). Patients are\r\n             ineligible if they received any other type of anti cancer agent (except agents to\r\n             maintain castrate status) within 2 weeks before first dose of study drug.\r\n\r\n        Part B:\r\n\r\n          -  Patients with known symptomatic brain metastases requiring steroids (above physiologic\r\n             replacement doses)\r\n\r\n          -  Major surgery (as defined by the Investigator) within 4 weeks of first dose of study\r\n             drug.\r\n\r\n          -  Radiation therapy within 4 weeks of first dose of study drug or prior irradiation to\r\n             >25% of the bone marrow. Palliative radiation for the alleviation of pain due to bone\r\n             metastasis will be allowed during the study\r\n\r\n          -  Systemic anti cancer therapy within 2 weeks of first dose of study drug (6 weeks for\r\n             bicalutamide, mitomycin C, or nitrosoureas and 4 weeks for abiraterone). Patients are\r\n             ineligible if they received any other type of anti cancer agent (except agents to\r\n             maintain castrate status) within 2 weeks before first dose of study drug.\r\n      ","sponsor":"Arvinas Inc.","sponsor_type":"Industry","conditions":"Prostate Cancer Metastatic","interventions":[{"intervention_type":"Drug","name":"Drug: ARV-110","description":"Part A: Daily oral dosages are predetermined by cohort review committee after the initial starting dose cohort after the first 28 days of treatment\r\nPart B: Daily oral dosage and schedule at a recommended Phase 2 dose based on data from Part A"}],"outcomes":[{"outcome_type":"primary","measure":"Part A: Incidence of Dose Limiting Toxicities of ARV-110","time_frame":"28 Days","description":"First Cycle Dose limiting toxicities characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug"},{"outcome_type":"primary","measure":"Part A: Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-110","time_frame":"28 Days","description":"Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug."},{"outcome_type":"primary","measure":"Part A: Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-110","time_frame":"28 Days","description":"Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing."},{"outcome_type":"primary","measure":"Part B: Measurement of PSA response rate per PCWG3 accessing anti-tumor activity of ARV-110","time_frame":"12 Weeks","description":"PSA response rate per PCWG3."},{"outcome_type":"primary","measure":"Part B: Measurement of overall RECIST response rate accessing the anti-tumor activity of ARV-110","time_frame":"12 Weeks","description":"Overall RECIST response rate in patients with measurable disease at baseline."},{"outcome_type":"primary","measure":"Part B: To evaluate the clinical anti-tumor activity of ARV-110 in patients with mCRPC (PSA measured PCWG and RECIST)","time_frame":"12 Weeks","description":"To evaluate the clinical anti-tumor activity of ARV-110 in patients with mCRPC in different subgroups of patients with mCRPC with predefined tumor genomic and molecular profiles or based on prior therapy."},{"outcome_type":"secondary","measure":"Part A: Anti-tumor activity based on the overall PSA response in the entire study population and in the subsets of patient based on the AR mutational status of their tumor.","time_frame":"28 Days","description":"The anti-tumor activity of ARV-110 will be assessed by evaluating the overall PSA response per PCWG3."},{"outcome_type":"secondary","measure":"Part A: Anti-tumor activity based on the overall RECIST response in the entire study population and in the subsets of patient based on the AR mutational status of their tumor.","time_frame":"28 Days","description":"The anti-tumor activity of ARV-110 will be assessed by evaluating the overall RECIST response rate."},{"outcome_type":"secondary","measure":"Part A: Anti-tumor activity based on the progression free survival in the entire study population and in the subsets of patient based on the AR mutational status of their tumor.","time_frame":"28 Days","description":"The anti-tumor activity of ARV-110 will be assessed by evaluating the time to event progression free survival."},{"outcome_type":"secondary","measure":"Part A: Anti-tumor activity based on the duration of response in the entire study population and in the subsets of patient based on the AR mutational status of their tumor.","time_frame":"28 Days","description":"The anti-tumor activity of ARV-110 will be assessed by evaluating the duration of response."},{"outcome_type":"secondary","measure":"Part A: Anti-tumor activity based on the time to progression in the entire study population and in the subsets of patient based on the AR mutational status of their tumor.","time_frame":"28 Days","description":"The anti-tumor activity of ARV-110 will be assessed by evaluating the time to progression."},{"outcome_type":"secondary","measure":"Part A: Anti-tumor activity based on the overall survival in the entire study population and in the subsets of patient based on the AR mutational status of their tumor.","time_frame":"28 Days","description":"The anti-tumor activity of ARV-110 will be assessed by evaluating the overall survival."},{"outcome_type":"secondary","measure":"Part A: Concentration-time curve (AUC) for single and multiple dose of ARV-110","time_frame":"28 Days","description":"PK parameters will be assessed when applicable after a single dose and after multiple once and twice daily doses. Assessment of pharmacokinetic parameter area under the concentration-time curve (AUC)."},{"outcome_type":"secondary","measure":"Part A: Maximum concentration (Cmax) for single and multiple dose of ARV-110","time_frame":"28 Days","description":"PK parameters will be assessed when applicable after a single dose and after multiple once and twice daily doses. Assessment of pharmacokinetic parameter maximum concentration (Cmax)."},{"outcome_type":"secondary","measure":"Part A: Minimum concentration (Cmin) for single and multiple dose of ARV-110","time_frame":"28 Days","description":"PK parameters will be assessed when applicable after a single dose and after multiple once and twice daily doses. Assessment of pharmacokinetic parameter minimum concentration (Cmin)."},{"outcome_type":"secondary","measure":"Part A: Time to maximum concentration (Tmax) for single and multiple dose of ARV-110","time_frame":"28 Days","description":"PK parameters will be assessed when applicable after a single dose and after multiple once and twice daily doses. Assessment of pharmacokinetic parameter time to maximum concentration (Tmax)"},{"outcome_type":"secondary","measure":"Part B: Concentration-time curve (AUC) for single and multiple dose of ARV-110","time_frame":"28 Days","description":"PK parameters will be assessed when applicable after a single dose and after multiple once and twice daily doses. Assessment of pharmacokinetic parameter area under the concentration-time curve (AUC)."},{"outcome_type":"secondary","measure":"Part B: Maximum concentration (Cmax) for single and multiple dose of ARV-110","time_frame":"28 Days","description":"PK parameters will be assessed when applicable after a single dose and after multiple once and twice daily doses. Assessment of pharmacokinetic parameter maximum concentration (Cmax)."},{"outcome_type":"secondary","measure":"Part B: Minimum concentration (Cmin) for single and multiple dose of ARV-110","time_frame":"28 Days","description":"PK parameters will be assessed when applicable after a single dose and after multiple once and twice daily doses. Assessment of pharmacokinetic parameter minimum concentration (Cmin)."},{"outcome_type":"secondary","measure":"Part B: Time to maximum concentration (Tmax) for single and multiple dose of ARV-110","time_frame":"28 Days","description":"PK parameters will be assessed when applicable after a single dose and after multiple once and twice daily doses. Assessment of pharmacokinetic parameter time to maximum concentration (Tmax)"},{"outcome_type":"secondary","measure":"Part B: Duration of response","time_frame":"12 Weeks","description":"From the date of first confirmed best overall response of CR or PR to the date of first progression per RECIST 1.1 or PCWG3, or death due to any cause without evidence of radiographic progression, whichever occurs first."},{"outcome_type":"secondary","measure":"Part B: Overall survival","time_frame":"12 Weeks","description":"Time interval from the date of first ARV-110 dose to the date of death due to any cause."},{"outcome_type":"secondary","measure":"Part B: Duration on therapy","time_frame":"12 Weeks","description":"Time from first study treatment to last study treatment"}]}
{"nct_id":"NCT03812146","start_date":"2019-03-01","phase":"N/A","enrollment":60,"brief_title":"Primary Care Treatment Integrating Motivation and Exposure","official_title":"An Integrated Brief Alcohol and PTSD Intervention for Veterans in Primary Care","primary_completion_date":"2021-06-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-10-31","last_update":"2020-10-22","description":"This project aims to develop and test an integrated brief intervention to reduce heavy alcohol use and PTSD severity in veterans receiving Veterans Affairs Primary Care. Standard brief alcohol interventions have been unsuccessful in reducing heavy drinking in traumatized individuals and current integrated treatment for alcohol use disorder and PTSD are too long to be delivered in Primary Care. Therefore, this application addresses this gap by developing an intervention tailored to the specific needs of heavy drinking veterans who have co- occurring PTSD. This study aims to incorporate two evidenced-based interventions: Brief Motivational Interviewing (BMI) with Prolonged Exposure for Primary Care (PE-PC). This newly developed brief intervention will be piloted in an open trial to gather veteran participant feedback and develop clinician training and fidelity procedures.","other_id":"1250312","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","intervention_model_description":"Open clinical trial","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  A score of 8-25 for men, 6-25 for women on the AUDIT and have past month drinking\r\n             (i.e., have not quit drinking over the last month)\r\n\r\n          -  Score 30 on the PTSD Checklist-5 (PCL-5) and report a traumatic event on the\r\n             Criterion A screener\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Score of a 26 or higher on the AUDIT\r\n\r\n          -  gross cognitive impairment as assessed by the Mini Mental Status Exam\r\n\r\n          -  current symptoms of mania or psychosis\r\n\r\n          -  currently in need of detox services\r\n\r\n          -  Have had a suicide attempt in the last two months or a current intent to commit\r\n             suicide as assessed on the P4 Screener. (Patients with recent suicide attempts or\r\n             intent may be enrolled following receipt of suicide prevention services)\r\n\r\n          -  Are currently receiving psychotherapy for heavy drinking or PTSD outside of PC within\r\n             the last 2 months\r\n\r\n          -  Have started or changed the dose of a psychotropic medication for heavy drinking or\r\n             PTSD in the last two months that was prescribed outside of VA PC\r\n\r\n          -  Have a preference to be directly referred to VA specialty care for heavy drinking or\r\n             PTSD.\r\n      ","sponsor":"Syracuse VA Medical Center","sponsor_type":"U.S. Fed","conditions":"Stress Disorders, Post-Traumatic|Alcohol-Related Disorders","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: PC-TIME","description":"PC-TIME consists of five, 30-minute sessions delivered over 8 weeks. Intervention will be delivered by a behavioral health provider and will consist of brief Prolonged Exposure for PTSD integrated with aspects of the Motivational Interviewing counseling approach."},{"intervention_type":"Behavioral","name":"Behavioral: PC-TAU","description":"PC-TAU consists of Brief Advice intervention from their PC medical provider that is built into the electronic medical record as a mandatory response to a positive screen. In addition, patients who score positive on the AUDIT-C or PC-PTSD are offered a referral to the PCMHI provider within the PC clinic. PCMHI in VA consists of licensed, independent providers (typically psychologists or clinical social workers) providing brief assessment and interventions to veterans and consultation to other members of the PC team. PCMHI sessions are typically focused on assessment, psycho-education, and supportive counseling."}],"outcomes":[{"outcome_type":"primary","measure":"Change in Clinician Administered PTSD Scale (CAPS)-5 severity rating","time_frame":"Baseline and 8 weeks","description":"This 30-item structured interview assesses DSM-5 symptoms of Posttraumatic stress disorder. It includes assessment of traumatic events and symptom severity ratings are based on symptom frequency and intensity. CAPS-5 total symptom severity score ranges 0-80, with higher scores representing higher severity (worse outcome)."},{"outcome_type":"primary","measure":"Change in daily drinking over past 30 days.","time_frame":"Baseline, 8 weeks, 14 weeks, and 20 weeks","description":"The Timeline Follow-back instrument is presented as a 30-day calendar and it is used to obtain count estimates of daily drinking."},{"outcome_type":"secondary","measure":"Post-intervention Treatment Engagement","time_frame":"20 weeks","description":"With HIPAA authorization, information from participants' VA administrative data will be extracted to assess if treatment condition relates to engagement in specialty treatment. Number of mental health or substance use visits attended between enrollment and 20 week follow-up will be extracted for each participant."},{"outcome_type":"secondary","measure":"Change in Depressive Symptom Severity","time_frame":"Baseline, 8 weeks, 14 weeks, and 20 weeks","description":"The Patient Health Questionnaire (PHQ-9) is a 9-item self-report measure used to assess depressive symptoms at each time point to evaluate change in severity. The PHQ-9 is a standard VA instrument with good psychometric properties. Scores range 0-27 with higher scores representing higher depressive symptom severity (worse outcome)."},{"outcome_type":"secondary","measure":"Change in Quality of Life perceptions","time_frame":"Baseline, 8 weeks, 14 weeks, and 20 weeks","description":"The World Health Organization Quality of Life (WHO QOL) instrument is a 26-item self-report measure used to assess individual's perception of quality of life in quality of life in physical, psychological, social relationships, and environment domains. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life) for each domain - physical (range 7-35); psychological (range 6-30); social relationship (range 3-15); environment (range 8-40)."}]}
{"nct_id":"NCT03823053","start_date":"2019-02-25","phase":"N/A","enrollment":30,"brief_title":"The Effect of the Core Stabilization Training on Respiratory Parameters , Functional Capacity and Balance in Scoliosis","official_title":"The Effect of Core Stabilization Training on Respiratory Parameters, Peripheral Muscle Strength, Balance, Functional Capacity and Quality of Life in Children With Adolescent Idiopathic Scoliosis","primary_completion_date":"2019-06-21","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-06-28","last_update":"2020-11-13","description":"The vertebral column is a structure that transfers the weight of the head and torso to the lower extremity, provides trunk movements and protects the spinal cord.A three dimensional deformity involving lateral flexion of the vertebrae in the frontal plane at 10  and above, including axial rotation and physiologic flexion (hypokyphosis) components in the sagittal plane, is defined as scoliosis. Adolescent idiopathic scoliosis (AIS) is a type of idiopathic scoliosis that occurs in the period from the onset of puberty (up to 10 years) until the closure of growth plates. Scoliosis is caused by postural, balance and neuromotor disorders as a primary cause of impaired sensory integrity, proprioceptive feedback deficits, secondary lung problems, organ disorders and pain. In addition, the quality of life in these individuals is also seen to decrease.Children with adolescent idiopathic scoliosis have inadequate respiratory function and a decrease in functional capacity. At the same time, these children show muscle weakness in certain parts of the body. The aim of this study was to investigate the relationship between home based core stabilization training, respiratory parameters, peripheral muscle strength, balance, functional capacity and quality of life in individuals with young scoliosis. The investigators suggest that the addition of core stabilization training to children with mild and moderate adolescent idiopathic scoliosis will produce good results.","other_id":"BVUsyildirim01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":10,"maximum_age":24,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adolescent Idiopathic Scoliosis diagnosis\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Documented diagnosis any of cardiopulmonary, neurological, orthopedic or mental\r\n             disorders which may affect the assessments results.\r\n\r\n          -  Subjects previously undertaken any of spinal surgeries.\r\n\r\n          -  Subjects involved in exercise training 3 or more days a week.\r\n      ","sponsor":"Bezmialem Vakif University","sponsor_type":"Other","conditions":"Adolescent Idiopathic Scoliosis","interventions":[{"intervention_type":"Other","name":"Other: Home Based Traditional Scoliosis Exercise","description":"Program will include posture exercises, strengthening exercises of interscapular muscle and limb, diaphragmatic breathing exercises and stretching exercises for lumbar extensor, hip flexor, hamstring, pectoral muscles. Exercises will be applied 1 sets of 10 repetitions and once a day."},{"intervention_type":"Other","name":"Other: Home Based Core Stabilization Training","description":"Program will include posture exercises, strengthening exercises of interscapular muscle and limb, diaphragmatic breathing exercises and stretching exercises for lumbar extensor, hip flexor, hamstring, pectoral muscles. In addition, the training group received core stabilization exercises for multifidus, transversus abdominis, diaphragm,erector spines, rectus abdominis, internal and external obliques, quadratus lumborum, gluteus maximus, and pelvic floor muscles.Exercises will be applied 1 sets of 10 repetitions and once a day."}],"outcomes":[{"outcome_type":"primary","measure":"Change from baseline Forced Vital Capacity (FVC) at 8 weeks","time_frame":"Eight weeks"},{"outcome_type":"primary","measure":"Change from baseline Forced Expiratory volume in 1 second (FEV1)at 8 weeks","time_frame":"Eight weeks"},{"outcome_type":"primary","measure":"Change from baseline Peripheral Muscle strength at 8 weeks","time_frame":"Eight weeks"},{"outcome_type":"primary","measure":"Change from baseline Balance at 8 weeks","time_frame":"Eight weeks"},{"outcome_type":"primary","measure":"Change from baseline distance covered in Six- Minute Walk Test at 8 weeks","time_frame":"Eight weeks"},{"outcome_type":"secondary","measure":"Change from baseline axial trunk rotation (ATR)","time_frame":"Eight weeks","description":"Measurements will be applied with Bunnell Scoliometer by physiotherapist."}]}
{"nct_id":"NCT03798119","start_date":"2019-02-25","phase":"Phase 4","enrollment":80,"brief_title":"TAF Switch in F3/4 CHB pt With Partial Response to NUC (ESTAB-AFPVR)","official_title":"Efficacy and Safety of Switching to Tenofovir Alafenamide for Chronic Hepatitis B Patients With Advanced Fibrosis and Partial Virologic Responses to Oral Nucleos(t)Ide Analogues","primary_completion_date":"2020-08-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2021-08-31","last_update":"2019-04-26","description":"A total of 80 adult chronic hepatitis B patients with advanced liver fibrosis (including fibrosis stage 3 and cirrhosis), who are currently on nucleot(s)ide analogs (except tenofovir alafenamide) therapy with detectable HBV DNA after 52 weeks of therapy will switch prior NUCs to TAF 25 mg/day for 96 weeks","other_id":"KMUHIRB-F(II)-20180111","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Male or female, age 20 years\r\n\r\n          2. CHB diagnosis confirmed by positive HBsAg or HBV DNA for more than 6 months, or\r\n             documented history of CHB in medical record before initiation of NUC therapy.\r\n\r\n          3. Currently maintained on nucleot(s)ide analogues (except TAF) therapy for more than one\r\n             year, with detectable HBV DNA after 52 weeks of therapy, detectable HBV DNA within 3-6\r\n             months prior to screening, and remains detectable HBV DNA at screening.\r\n\r\n          4. Patients with liver fibrosis stage 3 (defined as Metavir fibrosis stage 3 by liver\r\n             biopsy, or fibrosis-4 score 3.25 ~ 6.49, or ARFI 1.80 ~ 1.99 m/s, or Fibroscan\r\n             9.5~12.4 kPa), or cirrhosis (defined as Metavir fibrosis stage 4 by liver biopsy, or\r\n             APRI >2, or fibrosis-4 score  6.5, or ARFI  2.0 m/s, or Fibroscan 12.5 kPa, or\r\n             image diagnosis with splenomegaly or esophageal/gastric varices) at the initiation of\r\n             prior NUC therapy or during the prior NUC therapy. The liver biopsy should be within 5\r\n             years, or during the prior NUC therapy and other non-invasive assessments should be\r\n             within 6 months at the initiation of NUC therapy or during the prior NUC therapy.\r\n\r\n          5. Estimated creatinine clearance > 15 ml/min (using the Cockcroft-Gault method) within 6\r\n             months prior to screening. (Note: multiply estimated rate by 0.85 for women).\r\n\r\n          6. Willing and able to provide informed consent\r\n\r\n          7. Able to comply with dosing instructions for study drug administration and able to\r\n             complete the study schedule of assessments\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Pregnant women, women who are breast feeding or who believe they may wish to become\r\n             pregnant during the course of the study\r\n\r\n          2. Previous recipient of a liver transplant\r\n\r\n          3. Co-infection with human immunodeficiency virus (HIV) or hepatitis C (HCV) or hepatitis\r\n             D (HDV)\r\n\r\n          4. Severe or uncontrolled comorbidities, determined by the Investigator.\r\n\r\n          5. Known history of serum albumin level <3 g/dL, or total bilirubin level >3 mg/dL, or\r\n             presence of ascites.\r\n\r\n          6. Known history of hepatic encephalopathy, and/or variceal bleeding.\r\n\r\n          7. Malignancy history including hepatocellular carcinoma, except cancers curable by\r\n             surgical resection (e.g. basal cell skin cancer and squamous cell cancer within 5 yrs\r\n             of screening).\r\n\r\n          8. On any of the disallowed concomitant medications listed in the prior and concomitant\r\n             medications list (pg. 11). Subjects on prohibited medications who are otherwise\r\n             eligible will need a wash out period of at least 30 days prior to the Screening.\r\n\r\n          9. Males and females of reproductive potential who are unwilling to use \"effective\"\r\n             protocol-specified method(s) of contraception during the study.\r\n\r\n         10. Current substance or alcohol abuse judged by the investigator to potentially interfere\r\n             with subject compliance.\r\n\r\n         11. Any other clinical conditions that, in the opinion of the Investigator, would make the\r\n             subject unsuitable or unable to comply with any of the study procedures\r\n      ","sponsor":"Kaohsiung Medical University Chung-Ho Memorial Hospital","sponsor_type":"Other","conditions":"Hepatitis B|Fibrosis and Cirrhosis of Liver","interventions":[{"intervention_type":"Drug","name":"Drug: Tenofovir Alafenamide","description":"Subjects in this group will switch prior nucleot(s)ide analogs to Tenofovir Alafenamide 25 mg/day for 96 weeks"}],"outcomes":[{"outcome_type":"secondary","measure":"Changes in liver fibrosis","time_frame":"at week 48 and 96","description":"determined by Fibroscan"},{"outcome_type":"primary","measure":"Rate of virological response","time_frame":"at 48 weeks of TAF therapy.","description":"HBV DNA <LLOQ"},{"outcome_type":"secondary","measure":"Rate of virological response","time_frame":"at 96 weeks of treatment","description":"HBV DNA <LLOQ"},{"outcome_type":"secondary","measure":"Rate of ALT normalization","time_frame":"at week 48 and 96","description":"by local (<40 U/L), and AASLD (male ≤35, female ≤25 U/L) criteria"},{"outcome_type":"secondary","measure":"Changes of serum creatinine","time_frame":"at week 48 and 96"},{"outcome_type":"secondary","measure":"Changes of calculated creatinine clearance (Cockcroft-Gault)","time_frame":"at week 48 and 96"},{"outcome_type":"secondary","measure":"Changes in bone mineral density","time_frame":"at week 48 and 96"}]}
{"nct_id":"NCT03847857","start_date":"2019-02-21","phase":"Phase 3","enrollment":360,"brief_title":"Study of Porcine Fibrin Sealant in Preventing Cervical Anastomotic Leakage","official_title":"A Multicenter Prospective Randomized Controlled Study of Porcine Fibrin Sealant in Preventing Cervical Anastomotic Leakage for Esophageal or Junctional Carcinoma. (PLACE030)","primary_completion_date":"2023-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2025-12-31","last_update":"2020-10-14","description":"The primary objective is to evaluate the efficacy and assess the role of Porcine Fibrin Sealant (Bioseal) in preventing cervical anastomotic leakage after esophagectomy in the patients with resectable thoracic esophageal cancer and gastroesophageal junction cancer.","other_id":"B2019-011-01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"A(Surgery+PFS) Arm A consists of the concurrent application of Porcine Fibrin Sealant (PFS) on the gastroesophageal anastomosis during Mckeown surgery . Biological/Vaccine: Porcine Fibrin Sealant (PFS) 2.5ml Porcine Fibrin Sealant will be instilled over the cervical anastomose line.\r\nB(Surgery)Arm B for conventional anastomosis","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Histologic diagnosis of squamous cell carcinoma or adenocarcinoma of thoracic\r\n             esophageal carcinoma or gastroesophageal junction cancer with Stage T1-4aN0-3M0,\r\n             according to 8th edition of Union for International Cancer Control (UICC) staging\r\n             system\r\n\r\n          2. More than 6 months of expected survival\r\n\r\n          3. Age ranges from 18 to75 years\r\n\r\n          4. Absolute white blood cells count 4.0109/L, neutrophil 1.5109/L, platelets\r\n             100.0109/L, hemoglobin 90g/L, and normal functions of liver and kidney.\r\n\r\n          5. WHO performance status (PS) of 0-1\r\n\r\n          6. Informed consent will be obtained before the study\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients who have undergone definitive chemoradiotherapy\r\n\r\n          2. Patients with concomitant hemorrhagic disease\r\n\r\n          3. Patients with other uncontrollable status that cannot tolerate surgery\r\n\r\n          4. Patients with known hypersensitivity to the porcine fibrin sealant product\r\n\r\n          5. Pregnant or breast feeding\r\n\r\n          6. Patients cannot signed the informed consent document because of psychological quality,\r\n             family and social factors\r\n\r\n          7. Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more\r\n\r\n          8. Have a history of diabetes over 10 years and with poorly controlled blood sugar level\r\n\r\n          9. Patients with serious cardiac, respiratory, hepatic, renal,hematologic, immunological\r\n             disease or cachexy, who cannot tolerate surgery\r\n      ","sponsor":"Sun Yat-sen University","sponsor_type":"Other","conditions":"Esophageal Anastomotic Leak","interventions":[{"intervention_type":"Biological","name":"Biological: Porcine Fibrin Sealant (PFS)","description":"McKeown esophagectomy will be performed for patients with resectable thoracic esophageal carcinoma or gastroesophageal junction cancer. At last, 2.5ml Porcine Fibrin Sealant will be instilled over the cervical anastomose line."},{"intervention_type":"Procedure","name":"Procedure: McKeown esophagectomy","description":"McKeown esophagectomy including open or minimally invasive esophagectomy will be performed for patients with resectable thoracic esophageal carcinoma or gastroesophageal junction cancer. Two-field lymphadenectomy with total mediastinal lymph node dissection is performed during surgery."}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of postoperative cervical anastomotic leakage","time_frame":"within the first 3 months after esophagectomy","description":"Incidence of postoperative cervical anastomotic leakage Cervical anastomotic leakage will be diagnosed based on a combination of clinical presentation, radiological findings, and/or endoscopic findings within the first 3 months after the operation."},{"outcome_type":"secondary","measure":"Overall survival Overall survival (OS)","time_frame":"At end of trial- up to 2 years in follow up","description":"Overall survival Overall survival (OS) is defined as the time period from the date of enrollment to the date of death or the last follow up"},{"outcome_type":"secondary","measure":"Disease Free Survival Disease-free survival (DFS)","time_frame":"At end of trial- up to 2 years in follow up","description":"Disease Free Survival Disease-free survival (DFS) is defined as the time period from the date of R0 resection to the date of disease recurrence or death."},{"outcome_type":"secondary","measure":"Postoperative Complications","time_frame":"within the first 3 months after esophagectomy","description":"Postoperative complications will be recorded after each esophagectomy"}]}
{"nct_id":"NCT03813953","start_date":"2019-02-20","phase":"N/A","enrollment":160,"brief_title":"The Effect of Analgesic Modalities on Long Term Outcomes Following Open Liver Resection","official_title":"The Effect of Analgesic Modalities on Long Term Outcomes Following Open Liver Resection","primary_completion_date":"2019-05-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-06-16","last_update":"2019-01-23","description":"The LIVER (Local Infiltration Versus Epidural after Liver Resection) and LIVER 2 (Local Infiltration Versus Epidural after Liver Resection 2) studies were randomised controlled trials that compared epidural analgesia with local anaesthetic wound infiltration as post-operative analgesia in patients undergoing open liver resection. The overall findings of this trial were of similar rates of morbidity and pain control post-operatively but a reduced recovery time for the wound catheter group. As a result, wound catheter local anesthetic infiltration has become increasingly utilized in this unit and within other units throughout the country and worldwide. Epidural use has been associated with improved long term outcomes following abdominal cancer surgery. This study is therefore a long term follow up study of the LIVER and LIVER 2 trials to assess survival between the two groups.","other_id":"258352","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","intervention_model_description":"Long term follow up of previously randomised populations.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients who participated in the LIVER and LIVER 2 trials who had diagnoses of a\r\n             malignancy and underwent liver resection for this malignancy.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who had liver resection for benign disease. Patients who participated in the\r\n             LIVER/LIVER2 trials but who did not undergo resection.\r\n      ","sponsor":"University of Edinburgh","sponsor_type":"Other","conditions":"Liver Cancer","interventions":[{"intervention_type":"Procedure","name":"Procedure: Liver resection","description":"Resection of diseased liver"}],"outcomes":[{"outcome_type":"primary","measure":"Overall survival in months","time_frame":"5 years","description":"Number of months from the date of surgery to the date of death or the censor date"},{"outcome_type":"secondary","measure":"overall survival","time_frame":"3 years","description":"Number of months from the date of surgery to the date of death or the censor date"},{"outcome_type":"secondary","measure":"Disease free survival","time_frame":"5 years","description":"Number of months from the date of surgery to the date of disease recurrence or the censor date"}]}
{"nct_id":"NCT04414137","start_date":"2019-02-19","enrollment":20,"brief_title":"Description of Eosinophilic Pneumonia in BJI/PJI Treated by Daptomycin","official_title":"Description of Eosinophilic Pneumonia in BJI/PJI Treated by Daptomycin","primary_completion_date":"2021-01-20","study_type":"Observational","rec_status":"Recruiting","completion_date":"2021-09-01","last_update":"2020-11-09","description":"Daptomycin is an antibiotic from the family of cyclic lipopeptides, bactericide, concentration-dependent. Its spectrum concerns Gram-positive bacteria. Since the authorization of daptomycin in 2006, cases of eosinophilic pneumonia and pulmonary eosinophilia associated with its use have been reported in Europe and worldwide. The purpose of this study is to describe the mechanism of occurrence of this AE with dapto; Prolonged exposure and accumulation at the alveolar level could potentially have a role. Better understanding the mechanisms of appearance of this AE would provide predictive elements making it possible to limit the occurrence of this AE in the future","other_id":"19-283","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":15,"population":"patients having had an eosinophilic pneumonia under daptomycine given to treat an\r\n        osteoarticular infection (BJI/PJI) treated at the CRIOAc Lyon","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  patients having had an eosinophilic pneumonia under daptomycine given to treat an\r\n             osteoarticular infection (BJI/PJI)\r\n\r\n        Exclusion Criteria:\r\n\r\n        -\r\n      ","sponsor":"Hospices Civils de Lyon","sponsor_type":"Other","conditions":"Dactinomycin Adverse Reaction|Bone and Joint Infection","interventions":[{"intervention_type":"Other","name":"Other: Description of eosinophilic pneumonia due to daptomycine","description":"Description of eosinophilic pneumonia in patients treated by daptomycin for an osteoarticular infection"}],"outcomes":[{"outcome_type":"primary","measure":"description of BJI/BJI in patients having eosinophilic pneumonia due to daptomycin","time_frame":"2 months","description":"description of the BJI/PJI (symptoms, type of evolution, type of implant)"},{"outcome_type":"primary","measure":"description patients having eosinophilic pneumonia due to daptomycin","time_frame":"2 months","description":"description of the patients (average age, medical background)"},{"outcome_type":"primary","measure":"rate of eosinophilic pneumonia due to daptomycin in osteoarticular infection: the adverse event","time_frame":"6 months","description":"number of cases and description of the adverse event as assessed by CTCAE v4.0"},{"outcome_type":"primary","measure":"Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: dosage of daptomycine","time_frame":"6 months","description":"description of the use of daptomycine : dosage"},{"outcome_type":"primary","measure":"Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: duration of daptomycine","time_frame":"6 months","description":"description of the use of daptomycine : duration"},{"outcome_type":"primary","measure":"Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: daptomycine plasma clearance","time_frame":"6 months","description":"mean daptomycine plasma clearance (unit, liters per hour)"},{"outcome_type":"primary","measure":"Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: daptomycine volume distribution","time_frame":"6 months","description":"mean daptomycine volume of distribution (unit, liters)"}]}
{"nct_id":"NCT03801083","start_date":"2019-02-19","phase":"Phase 2","enrollment":59,"brief_title":"Adoptive Transfer of Tumor Infiltrating Lymphocytes for Biliary Tract Cancers","official_title":"A Phase 2 Study to Evaluate the Efficacy and Safety of Adoptive Transfer of Autologous Tumor Infiltrating Lymphocytes in Patients With Locally Advanced, Recurrent, or Metastatic Biliary Tract Cancers","primary_completion_date":"2023-01-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2024-01-31","last_update":"2021-02-05","description":"This is a Phase 2 study to evaluate the efficacy, using objective response rate, of a non-myeloablative lymphodepleting preparative regimen followed by infusion of autologous Tumor Infiltrating Lymphocytes (TIL) and high-dose aldesleukin in patients with locally advanced, recurrent, or metastatic biliary tract cancer. These are low-incidence cancers carry a poor prognosis. Participants will include patients with biliary tract cancers (BTC), including cholangiocarcinoma (both intrahepatic and extrahepatic) and gallbladder cancer, who are and are physically able to tolerate non-myeloablative chemotherapy and high-dose aldesleukin.","other_id":"18-126","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"The Phase 2 study will follow the Simon's optimal two-stage design. Fifteen patients will be included in the first stage; if there are 1 or fewer patients responding to therapy the trial will be terminated. If at least 2 responses were observed, expansion into Stage 2 to a total of 47 patients will occur. If at least 6 patients respond to therapy, the study therapy would be considered to have met its primary study goal.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Measurable locally advanced, recurrent, or metastatic biliary tract carcinoma\r\n             (including intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer, or\r\n             ampullary carcinoma).\r\n\r\n          -  Patients with locally advanced disease should be unresectable by conventional surgical\r\n             approaches.\r\n\r\n          -  Patients with distant metastatic spread must be refractory to approved standard\r\n             systemic therapies (such as gemcitabine, cisplatin, or equivalents) if they are\r\n             eligible to receive these treatments.\r\n\r\n          -  Patients must be co-enrolled on the companion protocol HCC 17-220 (Cell Harvest and\r\n             Preparation to Support Adoptive Cell Therapy Clinical Protocols and Pre-Clinical\r\n             Studies) and have available TIL cultures for therapy.\r\n\r\n          -  Patients with 3 or fewer brain metastases that are less than 1 cm in diameter and\r\n             asymptomatic are eligible. Lesions that have been treated with stereotactic\r\n             radiosurgery must be clinically stable for 1 month after treatment for the patient to\r\n             be eligible. Patients with surgically resected brain metastases are eligible.\r\n\r\n          -  Greater than or equal to 18 years of age and less than or equal to age 75\r\n\r\n          -  Able to understand and sign the Informed Consent Document\r\n\r\n          -  Clinical performance status of ECOG 0 or 1\r\n\r\n          -  Life expectancy of greater than three months\r\n\r\n          -  Patients of both genders who are of child-bearing potential must be willing to\r\n             practice birth control from the time of enrollment on this study and for up to four\r\n             months after receiving the treatment.\r\n\r\n          -  Serology:\r\n\r\n               -  Seronegative for HIV antibody. (The experimental treatment being evaluated in\r\n                  this protocol depends on an intact immune system. Patients who are HIV\r\n                  seropositive can have decreased immune-competence and thus be less responsive to\r\n                  the experimental treatment and more susceptible to its toxicities.)\r\n\r\n               -  Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody.\r\n                  If hepatitis C antibody test is positive, then patient must be tested for the\r\n                  presence of antigen by RT-PCR and be HCV RNA negative.\r\n\r\n          -  Women of child-bearing potential must have a negative pregnancy test because of the\r\n             potentially dangerous effects of the treatment on the fetus.\r\n\r\n          -  Hematology\r\n\r\n               -  Absolute neutrophil count greater than 1000/mm3 without the support of filgrastim\r\n\r\n               -  WBC  3000/mm3\r\n\r\n               -  Platelet count  100,000/mm3\r\n\r\n               -  Hemoglobin > 8.0 g/dl\r\n\r\n          -  Chemistry\r\n\r\n               -  Serum ALT/AST  to 3.5 times the upper limit of normal\r\n\r\n               -  Serum creatinine  to 1.6 mg/dl\r\n\r\n               -  Total bilirubin  to 2.0 mg/dl, except in patients with Gilbert's Syndrome who\r\n                  must have a total bilirubin less than 3.0 mg/dl.\r\n\r\n          -  More than four weeks must have elapsed since any prior systemic therapy at the time\r\n             the patient receives the preparative regimen, and patients' toxicities must have\r\n             recovered to a clinically manageable level (except for toxicities such as alopecia or\r\n             vitiligo). (Note: Patients may have undergone minor surgical procedures within the\r\n             past 3 weeks, as long as all toxicities have recovered to grade 1 or less)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Women of child-bearing potential who are pregnant or breastfeeding because of the\r\n             potentially dangerous effects of the treatment on the fetus or infant.\r\n\r\n          -  Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency\r\n             Disease).\r\n\r\n          -  Concurrent opportunistic infections (The experimental treatment being evaluated in\r\n             this protocol depends on an intact immune system. Patients who have decreased immune\r\n             competence may be less responsive to the experimental treatment and more susceptible\r\n             to its toxicities).\r\n\r\n          -  Active systemic infections (e.g.: requiring anti-infective treatment), coagulation\r\n             disorders or any other active major medical illnesses.\r\n\r\n          -  History of clinically significant major organ autoimmune disease\r\n\r\n          -  Concurrent systemic steroid therapy.\r\n\r\n          -  History of severe immediate hypersensitivity reaction to any of the agents used in\r\n             this study.\r\n\r\n          -  History of active coronary or ischemic symptoms.\r\n\r\n          -  Documented LVEF of less than or equal to 45%; note: testing is required in patients\r\n             with:\r\n\r\n               -  Age > 65 years' old\r\n\r\n               -  Clinically significant atrial and or ventricular arrhythmias including but not\r\n                  limited to: atrial fibrillation, ventricular tachycardia, second or third degree\r\n                  heart block or have a history of ischemic heart disease, chest pain.\r\n\r\n          -  Documented FEV1 less than or equal to 60% predicted tested in patients with:\r\n\r\n               -  A prolonged history of cigarette smoking (20 pk/year of smoking within the past 2\r\n                  years).\r\n\r\n               -  Symptoms of respiratory dysfunction\r\n\r\n          -  Patients who are receiving any other investigational agents.\r\n      ","sponsor":"Udai Kammula","sponsor_type":"Other","conditions":"Biliary Tract Cancer|Cholangiocarcinoma|Biliary Tract Neoplasms","interventions":[{"intervention_type":"Biological","name":"Biological: Tumor Infiltrating Lymphocytes (TIL)","description":"TIL are to be infused intravenously through a central vein catheter over 20-30 minutes followed by Aldesleukin, administered at a dose of 600,000 IU/kg (based on total body weight) as an intravenous bolus over a 15-minute period approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to a maximum of 6 doses."}],"outcomes":[{"outcome_type":"primary","measure":"Objective Response Rate (ORR)","time_frame":"Up to 24 months","description":"Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1): Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to <10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of at least 5 mm. The appearance ≥1 new lesion(s) is considered progression.. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. ORR (proportion of patients) = # with CR + # with PR / # with CR + # with PR + # with SD + # with PD."},{"outcome_type":"secondary","measure":"Complete response rate (CRR)","time_frame":"Up to 24 months","description":"Proportion of patients with complete response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1): Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to <10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of at least 5 mm. The appearance ≥1 new lesion(s) is considered progression.. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. CRR (proportion of patients) = # with CR / # with CR + # with PR + # with SD + # with PD."},{"outcome_type":"secondary","measure":"Duration of Response (DOR)","time_frame":"Up to 24 months","description":"Time between the initial response to treatment per Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) and subsequent disease progression among patients achieving Complete Response (CR) or Partial Response (PR). Per RECIST v1.1, Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. DOR is measured as the time between the initial response to treatment per RECIST and subsequent disease progression."},{"outcome_type":"secondary","measure":"Disease control rate (DCR)","time_frame":"Up to 24 months","description":"Proportion of patients with response or stable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1):Complete Response (CR):disappearance of all target lesions.Any pathological lymph nodes (target or non-target) with reduction in short axis to <10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression. Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. DCR (proportion of patients) = # with CR + # with PR + # with SD / # with CR + # with PR + # with SD + # with PD."},{"outcome_type":"secondary","measure":"Progression-free survival (PFS)","time_frame":"Up to 24 months","description":"The length of time after TIL infusion treatment that a patient lives with disease that does not progress per RECIST v1.1. Per RECIST, Progressive Disease (PD): ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression."},{"outcome_type":"secondary","measure":"Overall survival (OS)","time_frame":"Up to 24 months","description":"The length of time from the start of treatment that patients are still alive."},{"outcome_type":"secondary","measure":"EORTC Quality of Life Questionnaire-Core 30 (QLQ-C30)","time_frame":"Prior to treatment and after treatment; Up to 24 months","description":"The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) v 3.0 is a multi-dimensional assessment of health-related quality of life (HRQoL). EORTC QLQ-C30 includes: five (5) multi-item functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning); three (3) multi-item symptom scales (fatigue, nausea, vomiting, pain); six (6) symptom single-item scales (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties); (1) Global Health Status scale; (1) Global HRQoL scale. Each scale is measured from 0 to 100 after a linear transformation. Higher scores for functioning scales and for the Global Health Status or Global HRQoL indicate a higher level of functioning and a better HRQoL respectively, whereas higher scores in symptom scales represent a higher level of symptoms. Assessment of change is assessed across the 15 different domains."},{"outcome_type":"secondary","measure":"EuroQol 5 dimensions 5 levels (EQ-5D-5L)","time_frame":"Prior to treatment and after treatment; Up to 24 months","description":"The EuroQol 5 dimensions 5 levels (EQ-5D-5L) provides a brief five-dimensional assessment of patient HRQoL on five levels along with a numeric rating of patient perceived overall health. The EQ-5D-5L contains the following content: (5) dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression); (5) levels within each dimension (no problems, slight problems, moderate problems, severe problems, extreme problems); visual analogue scale of overall health status (number from 0 to 100); Each dimension is expressed as a value from 1 to 5 depending on the level selected. The sum of the 5-dimensional values can be combined into a 5-digit number that describes the patient's health state. The visual analogue scale number is a quantitative measure of health outcomes that reflects the patient's own judgement. Higher scores are associated with a greater level of perceived health difficulty."}]}
{"nct_id":"NCT04339647","start_date":"2019-02-18","phase":"N/A","enrollment":653,"brief_title":"Effect of the SIMS Programme on Preschool Children's Oral Hygiene Level","official_title":"Effect of the Community-based SIMS Programme on Preschool Children's Oral Hygiene Level: A Cluster Randomised Control Trial","primary_completion_date":"2019-10-17","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-11-17","last_update":"2020-04-09","description":"This is a cluster randomised control trial targeting 5-6-year-old children and their parents in Kampar district, Perak, Malaysia for a period of 6 months. In total, 28 preschools are randomly assigned into intervention and control group (14 preschools per group). Sample size for each group is 317 children. The intervention group receives the SIMS programme (SIMSP) which is an improved version of the usual care, while the control group receives the usual care. Usual care in defined as the existing preschool oral health programme (POHP) offered by the Ministry of Health. The SIMSP is formulated based on the recommendations from the National Oral Health Survey of Preschool Children's (2015) report. It comprises active participation of dental therapists (DT), parents and class teachers in children's oral health. The concept of the SIMSP is that improvement in oral health behaviours and oral hygiene of preschool children would result in improvement of gingival health and caries level in their permanent teeth in the long term. On the other hand, the control group involves DT visiting preschools twice a year without parental nor teachers active involvement. The scientific hypothesis of the study is that the SIMSP is more effective to improve oral hygiene level of preschool children than the POHP over 6 months. The primary objective of the study is to assess the effect of the SIMSP versus the POHP in improving oral hygiene level among 5-6-year-old children over 6 months. The secondary objectives are to assess the changes in oral health behaviours among the children and oral health literacy among parents over 6 months.","other_id":"IIRG035A","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","intervention_model_description":"Cluster Randomised Controlled Trial","sampling_method":"","gender":"All","minimum_age":5,"maximum_age":6,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Children who are healthy\r\n\r\n          -  Preschool children who can understand Malay language\r\n\r\n          -  Parents who can speak and write in Malay language\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Children with chronic medical conditions, dental/oral developmental conditions, long\r\n             term medications, and physical disability\r\n      ","sponsor":"University of Malaya","sponsor_type":"Other","conditions":"Dental Plaque","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: The SIMS programme","description":"The intervention targets 5-6-year-old preschool children and their parents. Apart from the usual care, 5-6-year-old children receive oral health lessons and supervised daily tooth brushing (1000ppm F) at school over a period of 6 months, as well as home tooth brushing supervision by parents for 6 months. Parents/guardians attend a meeting with a DT team at school to discuss on child's oral health status, receive OHE and free toothbrush and fluoride toothpaste (1000ppm F) for child home tooth brushing, and receive 10 oral health infographic messages from DT over a period of 5 months (with printed versions available)."}],"outcomes":[{"outcome_type":"primary","measure":"The mean decrement in plaque score assessed using the Oral Cleanliness Index","time_frame":"6 months","description":"The mean decrement in plaque score from baseline to follow up between the intervention and control group will be assessed. Assessment for the presence of visible plaque will involve examining the labial surfaces of upper right to upper left primary canines. Each of the surface is assessed by scoring; 0 = teeth appear clean, 1 = a little plaque visible (existence of plaque around the labial cervical margins and covering < ½ of labial tooth surfaces), 2 = substantial amount of plaque visible (plaque covering > ½ labial tooth surfaces), and 9 = assessment cannot be made (there is no teeth in both anterior segments for plaque assessment). Total score is the sum of scores from the 6 surfaces. Mean decrement score is obtained by subtracting mean score at follow up from mean score at baseline. Finally, mean decrement scores of intervention and control group are compared."},{"outcome_type":"secondary","measure":"Changes in child's oral health behaviours assessed using a self-reported questionnaire by parents","time_frame":"6 months","description":"Changes in the prevalence of good oral health behaviours. The changes are recorded as follows: Brushing teeth with fluoride toothpaste (yes, no), tooth brushing frequency (at least 2x/day, < 2x/day), frequency of monitoring child's tooth brushing (daily, do not monitor), bottle feeding (yes, no), bottle feeding frequency (daily, infrequent), bottle feeding at night (yes, no), sugar intake (up to 4x/day, > 5x/day), dental visit (< 1 yr, between 1-2 yr, > 2 yr)"},{"outcome_type":"secondary","measure":"The mean increment of oral health literacy score of parents/guardians assessed using The Dental Health Literacy Assessment Index (DHLAI)","time_frame":"6 months","description":"The DHLAI consists of 3 domains; (a) Oral Health Knowledge domain (12 items). Each item is assessed by one correct answer from 4 options. Total score = sum scores of correct answers with score range from 0-12; (b) Comprehension domain (5 items). Each item is scored by true/false answer options. Total score = the sum scores of correct answers with score range from 0-5; (c) Skills and Motivation domain (39 items). Each item is assessed using a 5-point Likert scale (strongly disagree to strongly agree). Total score = sum scores of all items with score range from 0-39. Total score of OHL = sum of scores from the 3 domains with score range from 0-56. Mean increment scores of total OHL and the 3 domains are calculated by subtracting the respective scores at baseline from follow up scores. The mean scores were compared between intervention and control group."}]}
{"nct_id":"NCT03737461","start_date":"2019-02-18","phase":"Phase 2/Phase 3","enrollment":112,"brief_title":"Efficacy of Intradiscal Injection of BM-MSC in Subjects With Chronic Low Back Pain (LBP) Due to Lumbar Degenerative Disc Disease (DDD) Unresponsive","official_title":"A Phase 2/3 Prospective, Multicentre Randomized, Double-blind Trial, Comparing Intra-discal Allogeneic Adult BM-MSC Therapy and Sham-treated Controls in Subjects With Chronic LBP Due to Lumbar DDD Unresponsive to Conventional Therapy","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-12-31","last_update":"2020-04-10","description":"This will be a multicenter, prospective, double blind, randomized phase 2/3 trial comparing culture-expanded allogeneic adult BM-MSCs with sham-treated controls. This trial will evaluate the efficacy of intradiscal injection of BM-MSCs in chronic low back pain due to lumbar degenerative disc disease (DDD) unresponsive to conventional therapy . Visual analog scale (VAS) and functional status (by Oswestry Disability Index - ODI) will be evaluated 12 months after treatment, defining responders in case of improvement of VAS for pain of at least 20% and 20 mm between baseline and month 12, or improvement of ODI of 20% between baseline and month 12.","other_id":"UF 9766","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age between 18 and 60 years.\r\n\r\n          -  Symptomatic chronic low back pain unresponsive to conservative therapy (including\r\n             physical therapy performed during at least 1 month before inclusion and pain\r\n             medication with level 2 analgesics in failure or intolerant to level during at least 1\r\n             month) for at least 3 months.\r\n\r\n          -  DDD assessed by (Pfirrmann's score modified Griffith et al) grade 4 to 7 at one level.\r\n             If second level, it should be adjacent (Pfirrmann's score 1-4 maximum)\r\n\r\n          -  Low back Pain baseline > 40 mm on VAS (0-100).\r\n\r\n          -  NSAID washout of at least 2 days before screening\r\n\r\n          -  Painkillers washout of at least 24 hours before screening\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Congenital or acquired diseases leading to spine deformations that may upset cell\r\n             application (hyperlordosis, scoliosis, isthmus lesion, sacralization and\r\n             hemisacralization).\r\n\r\n          -  Symptomatic posterior lumbo-articular osteoarthritis or predominant facet syndrome on\r\n             Xray or MRI (osteophyte and facet hypertrophy).\r\n\r\n          -  Prior to the screening visit, has received:\r\n\r\n          -  Oral corticosteroid therapy within the previous 3 months, OR\r\n\r\n          -  Intramuscular, intravenous or epidural corticosteroid therapy within the previous 3\r\n             months\r\n\r\n          -  Spinal segmental instability (defined by lumbar dynamic X-Ray in extension/flexion\r\n             with antero-post translation > 3 mm and/or angular mobility > 15).\r\n\r\n          -  Spinal canal stenosis (Schizas score > B).\r\n\r\n          -  History of spinal infection.\r\n\r\n          -  Lumbar disc herniation with non truncated sciatica or cruralgia, as well as lumbar\r\n             cysts and radiculopathy\r\n\r\n          -  Previous discal puncture or previous spine surgery.\r\n\r\n          -  DDD on 3 levels, or DDD on 2 levels but not adjacent, or DDD with modic 2 or 3 phases\r\n\r\n          -  Patients not eligible to the intravertebral disc surgery\r\n\r\n          -  Patients who have the risk to undergo a surgery in the next 6 months\r\n\r\n          -  Obesity with body mass index (BMI in Kg/size in m2) greater than 35 (obesity grade\r\n             II).\r\n\r\n          -  Participation in another clinical trial or treatment with another investigational\r\n             product within 30 days prior to inclusion in the study.\r\n\r\n          -  Abnormal blood tests: hepatic (alanine aminotransferase (ALT) and/or aspartate\r\n             aminotransferase (AST) >1.5  upper limit of normal (ULN)), renal, pancreatic or\r\n             biliary disease, blood coagulation disorders, anemia or platelet count of <100  109/\r\n\r\n          -  Significant medical problems, such as uncontrolled hypertension, symptomatic heart\r\n             failure; or any other clinically relevant condition or current medication that in the\r\n             opinion of the investigator contra-indicates the use of any of the study or rescue\r\n             medications.\r\n      ","sponsor":"University Hospital, Montpellier","sponsor_type":"Other","conditions":"Recurrent Low Back Pain|Degenerative Disc Disease (DDD)","interventions":[{"intervention_type":"Drug","name":"Drug: Allogenic BM-MSCs Injection","description":"Cell dose will be 205 million cells suspended in 2 ml of HypoThermosol isotonic transport solution"},{"intervention_type":"Other","name":"Other: Sham Procedure","description":"sham-maneuver as in the cell-treated patients are added, consisting in anesthetic infiltration with 2 ml of 1% xylocaine in the paravertebral muscles close to the affected segment."}],"outcomes":[{"outcome_type":"secondary","measure":"Pain killers","time_frame":"baseline, 1, 3,6,12 and 24 months","description":"assessement of consumption of painkillers medication. Rescue medication use will be recorded throughout the study duration by a diary file."},{"outcome_type":"primary","measure":"Change from Baseline Pain Clinical response at 12 months","time_frame":"baseline to month 12","description":"The clinical response is defined as the Pain relief measure with Visual Analogue Scale (VAS) of at least 20 mm decrease on VAS scale between baseline and month 12."},{"outcome_type":"primary","measure":"Change from Baseline Oswestry Disability Index (ODI) measure at 12 months","time_frame":"baseline to month 12","description":"at least 20% improvement of functional index ODI at month 12 compared to baseline."},{"outcome_type":"secondary","measure":"Measure disability and quality of life evolution of the patient","time_frame":"Baseline, 3,6,12 and 24 months","description":"Assessed by Short Form-36 Health Survey (SF-36) :\r\nThe eight sections are vitality, physical functioning, bodily pain, general health, perceptions, physical role functioning, emotional role functioning, social role functioning and mental health A score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability."},{"outcome_type":"secondary","measure":"Disability and quality of life evolution","time_frame":"baseline, 3,6,12 and 24 months","description":"global assessment by the patient and the physician. Overall pain intensity in the lumbar spine (1 = none, 2 = mild, 3 = moderate, 4 = severe, 5 = extreme); patient's global assessment of disease activity (1 = very good, 2 = good, 3 = fair, 4 = poor, 5 = very poor); physician's global assessment of disease activity (1 = very good, 2 = good, 3 = fair, 4 = poor, 5 = very poor) will be performed at 0, 3, 6, 12 and 24 months."},{"outcome_type":"secondary","measure":"Measure of the Chronic low back pain","time_frame":"baseline, 1, 3,6,12 and 24 months","description":"assessement of pain by the Visual Analogue pain Scale (VAS) during 24 months. Min value 0 - max value 100 , where 0 represents no pain and 100 represents the worst pain imaginable."},{"outcome_type":"secondary","measure":"Employment and work status","time_frame":"baseline, 1, 3,6,12 and 24 months","description":"Assessement of employment and work status. For this, patients will be assign to one of 4 categories designated as \"employable\" which included those who were unemployed due to pain, employed but on sick leave, laid off, or working. The other categories include retired, disabled, and elderly at least 60 years of age, eligible for social security."},{"outcome_type":"secondary","measure":"Structural assessment","time_frame":"baseline, 1, 3,6,12 and 24 months","description":"Evolution of affected disc(s) by quantitative Magnetic Resonance Imaging (MRI) density measurements in T2 and T1spin/echo and T1rho weighted images performed at 0, 6 12 and 24 months used as an indication of disc fluid and glycosaminoglycan (GAG) content. The \"quality\" of the patient's lumbar disc will be monitored non invasively using T2-weighted MRI sagittal images (Orozco et al., 2011) and, in T1spin/echo MRI. Lumbar disc grading will be performed in the sagittal T2 weighted images by two physicians independently who were experienced in MRI of the spine. They will review each intervertebral disc from L1-2 to L5-S1 by the modified Pfirrmann criteria. The modified Pfirrmann grading system assesses degenerated intervertebral discs by MRI for the asymmetry in disc structure, distinction of the nucleus and the annulus, signal intensity of intervertebral discs and height of intervertebral discs and assigns grade 1 to 8 for disc degeneration (Table by Griffin et al. Spine 2007)."},{"outcome_type":"secondary","measure":"Evaluation of cost","time_frame":"24 months","description":"We will compare the medical and non-medical costs between the two groups of patient. Costs will be identified for a one-year time horizon.\r\nFor this purpose, resource use in each arm will be collected in physical units in the electronic Case Report Form (eCRF) at each clinical centre as follows:\r\nAcute care medical hospitalisations related to DDD\r\nAcute care surgical hospitalisations related to DDD\r\nRehabilitation hospitalisations related to DDD\r\nAnalgesics\r\nWork disruption Resource use will be valued using production costs specific to each country or to the country having included the highest number of patients, depending on the number of patients actually included in each clinical centre."},{"outcome_type":"secondary","measure":"Immune response / Analytical control","time_frame":"baseline, 1, and 6 months","description":"The assessment of the biological effect of allogeneic MSC on recipient immune response will be studied by multiparametric flow-cytometry as well as monitoring of anti HLA-I (human leukocyte antigen I) antibodies response."},{"outcome_type":"secondary","measure":"reporting of Serious Adverse Events (SAE)","time_frame":"baseline, 1, 3,6,12 and 24 months","description":"Define the safety outcomes of the clinical trial with the record of SAE"}]}
{"nct_id":"NCT03843606","start_date":"2019-02-16","phase":"N/A","enrollment":11,"brief_title":"Modified Ketogenic Diet in Patients With McArdle Disease Part A","official_title":"Modified Ketogenic Diet in Patients With McArdle Disease Part A - a Pilot Study","primary_completion_date":"2019-05-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-05-08","last_update":"2019-05-10","description":"McArdle disease, glycogen storage disease type V, is a rare metabolic disease. Affected individuals are unable to utilize sugar stored as glycogen in muscle. We hypothesize that a modified ketogenic diet could be a potential treatment option, by providing ketones as alternative fuel substrates for working muscle. In this open interventional pilot study we wish to investigate 3 different modified ketogenic diet regimes, to find an optimal composition of a modified ketogenic diet that ensures adequate degree of ketosis and at the same time is well tolerated for patients with McArdle disease.","other_id":"H-18013022","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Open interventional study to investigate the effects of 3 different ketogenic diet regimes","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Genetically confirmed GSDV\r\n\r\n          -  Patient is willing and able to provide written informed consent prior to\r\n             participation.\r\n\r\n          -  Patient is ambulatory.\r\n\r\n          -  Women in fertile age must be willing to practice the following medically acceptable\r\n             methods of birth control\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patient has any prior or current medical conditions that, in the judgment of the\r\n             Investigator, would prevent the patient from safely participating in and/or completing\r\n             all study requirements.\r\n\r\n          -  Pregnancy or breastfeeding\r\n\r\n          -  Patient does not have the cognitive capacity to understand/comprehend and complete all\r\n             study assessments\r\n\r\n          -  Patients with porphyria or disorders of fat metabolism (primary carnitine deficiency,\r\n             carnitine palmitoyltransferase I or II, -oxidation defects etc.).\r\n      ","sponsor":"Rigshospitalet, Denmark","sponsor_type":"Other","conditions":"McArdle Disease","interventions":[{"intervention_type":"Other","name":"Other: Modified ketogenic diets","description":"Different diet composition"}],"outcomes":[{"outcome_type":"primary","measure":"Heart rate","time_frame":"2 times","description":"heart rate during constant load cycling exercise"},{"outcome_type":"secondary","measure":"Compliance","time_frame":"3 weeks","description":"Dietary diary to evaluate compliance and diet acceptability"},{"outcome_type":"secondary","measure":"indirect calorimetry","time_frame":"2 times","description":"Oxidation rates measured via indirect calorimetry during constant load cycling calorimetry"},{"outcome_type":"secondary","measure":"level of ketosis","time_frame":"daily","description":"Ketone bodies in the blood"},{"outcome_type":"secondary","measure":"Safety parameters","time_frame":"2 times","description":"Blood samples"},{"outcome_type":"secondary","measure":"Perceived exertion","time_frame":"2 times","description":"Borg scale during constant load cycling"},{"outcome_type":"secondary","measure":"other blood samples","time_frame":"2 times","description":"Cholesterol, fatty acids, hormones, ammonia"}]}
{"nct_id":"NCT04544709","start_date":"2019-02-14","phase":"Phase 4","enrollment":100,"brief_title":"Intradiscal Platelet Rich Plasma","official_title":"Intradiscal Platelet-Rich Plasma Injection for Chronic Discogenic Low Back Pain","primary_completion_date":"2023-02-14","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2024-07-30","last_update":"2020-09-10","description":"To assess changes in pain and function in patients with discogenic low back pain after a standard of care intradiscal injection of Platelet-Rich Plasma (PRP).","other_id":"IRB 117455","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age greater than 18 years of age at day of enrollment.\r\n\r\n          2. Clinical diagnosis of refractory discogenic low back pain for >3 months.\r\n\r\n          3. Magnetic resonance imaging pathology consistent with clinical symptoms/signs or\r\n             positive lumbar provocative discography according to SIS/IASP standards at one or two\r\n             levels.\r\n\r\n          4. Back pain greater than leg pain with an intensity of at least 4/10 or higher using the\r\n             Numerical Rating Scale (NRS).\r\n\r\n          5. Pain duration of more than 12 weeks despite trial of conservative therapy\r\n             (medications, physical therapy, or chiropractic care) for 2 months.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Refusal to participate, provide consent, or provide follow-up information for the\r\n             24-month duration of the study.\r\n\r\n          2. Contraindications to intradiscal injection of PRP (active infection, bleeding\r\n             disorders, current anticoagulant or antiplatelet medication use, allergy to iodinated\r\n             contrast, penicillin or clindamycin and pregnancy or breastfeeding).\r\n\r\n          3. More than 2 levels of clinical or discogram proven pain.\r\n\r\n          4. Non-discogenic source of low back pain as identified by separate diagnostic blocks.\r\n\r\n          5. Negative lumbar provocation discography.\r\n\r\n          6. Active moderate to severe lumbar radiculopathy.\r\n\r\n          7. Intradural disc herniation.\r\n\r\n          8. Spinal fracture within the past 6 months.\r\n\r\n          9. Steroid injection in the spine within the last 30 days.\r\n\r\n         10. Any intradiscal injection other than contrast dye or anesthetic in the last 30 days.\r\n\r\n         11. Prior fusion at level considered to be the source of the pain.\r\n\r\n         12. Prior lumbar spine surgery within the last 6 months.\r\n\r\n         13. AP diameter of spinal canal less than or equal to 9mm at level to be treated.\r\n\r\n         14. Severe uncontrolled medical condition.\r\n\r\n         15. Moderate to severe hepatic dysfunction.\r\n\r\n         16. Severe psychological illness.\r\n\r\n         17. History of Inflammatory arthritis.\r\n\r\n         18. Malignancy within past 5 years except basal cell or squamous cell skin cancer.\r\n\r\n         19. Current use of equal to greater than 30mg morphine-equivalent per day of opioid use.\r\n\r\n         20. A history of alcohol or drug abuse within past 5 years.\r\n\r\n         21. Use of any investigational drug within past 30 days.\r\n\r\n         22. A known allergy or sensitivity to citrate (used for processing PRP).\r\n\r\n         23. Severe anaphylactic/anaphylactoid reaction to any medications used.\r\n\r\n         24. Pending litigation involving subject's back pain.\r\n\r\n         25. No insurance coverage for any subsequent tests or procedures.\r\n\r\n         26. Disc protrusion greater than 5mm from base of vertebral body.\r\n\r\n         27. Greater than 50% disc height loss at involved level(s).\r\n\r\n         28. Inability or unwillingness to continue rehabilitation protocols.\r\n      ","sponsor":"University of Utah","sponsor_type":"Other","conditions":"Discogenic Pain|Low Back Pain|Chronic Pain","interventions":[{"intervention_type":"Drug","name":"Drug: Low back intradiscal injection of platelet rich plasma (PRP)","description":"SOC Intradiscal Lumbar PRP Procedure : A small amount of blood is drawn from you, then it is spun in a centrifuge to obtain only the platelets and few other cells. After being spun the small amount of platelets will be injected into the specific disc that is believed to be causing pain in an attempt to help reduce inflammation and pain at the site. The injection will be done under fluoroscopic guidance (x-ray) that allows very careful and precise placement of the needle."}],"outcomes":[{"outcome_type":"primary","measure":"Numeric Rating Scale for Pain at 2 month Follow-up","time_frame":"2 months","description":"Proportion of participants with >80% and >50% decrease in back pain on the Numeric Rating Scale pain score at the 2-month follow-up assessment."},{"outcome_type":"secondary","measure":"Numeric Rating Scale Median","time_frame":"5 years","description":"Change in median Numeric Rating Scale pain score"}]}
{"nct_id":"NCT04343469","start_date":"2019-02-11","phase":"N/A","enrollment":90,"brief_title":"Effects of Morbid Obesity and Bariatric Surgery on Brain Inflammation, and Activation of Central Reward System","official_title":"Effects of Morbid Obesity and Bariatric Surgery on Brain Inflammation, Insulin Resistance and Activation of Central Reward System Studied Using PET- and MRI-imaging","primary_completion_date":"2022-09-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-09-30","last_update":"2020-04-13","description":"Background: The investigators have found that obesity and insulin resistance result in significantly increased brain insulin-stimulated glucose uptake, whereas in every other tissue glucose uptake is lower in the obese compared to lean individuals. One possible explanation to this could be central inflammation and activation of brain glial cells, which has been shown to occur in animal models of obesity. Aims: The objective of this study is to investigate whether there is brain inflammation in human obesity, and whether weight loss following bariatric surgery decreases brain inflammation. Methods: A total of 60 morbidly obese subjects, assigned for Roux-en-Y gastric bypass or for sleeve gastrectomy according to routine treatment protocols will be recruited for this study. A control group of 30 healthy subjects will also be recruited. The following studies will be performed to patients and healthy subjects: 1) structural MRI and MRS, 2) functional MRI, 3) PET imaging of cerebral inflammation and astrocyte activation using [11C]-PK11195, 4) measurement of whole-body and tissue insulin sensitivity by combining hyperinsulinemic, euglycemic clamp with [18F]-FDG-PET, 5) neuropsychological testing. The study procedures will be repeated for the morbidly obese 6 months postoperatively.","other_id":"T26/2019","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","intervention_model_description":"Obese and healthy ones are compared at baseline and obese are compered to healthy ones 6 months after bariatric surgery.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        For the morbidly obese subjects:\r\n\r\n          1. BMI 35.0-45.0 kg/m2, or BMI 32.0-45.0 kg/m2 and diagnosed diabetes\r\n\r\n          2. Eligible to bariatric surgery evaluated according to normal treatment paradigm\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Metal objects in the body (including pacemakers, metallic artificial valve prostheses,\r\n             inner ear implants, surgical clips, braces, foreign fragments)\r\n\r\n          2. Previous participation in PET studies\r\n\r\n          3. Pregnancy\r\n\r\n          4. Poor compliance, alcohol or drug abuse\r\n\r\n          5. Weight over 150 kg or waist circumference over 150 cm\r\n\r\n          6. Diabetes with fasting glucose levels 7.0 mmol/L, or treatment with insulin\r\n\r\n          7. Any chronic disease, medication or condition that could create a hazard to subject\r\n             safety, endanger study procedures or interfere with the interpretation of results.\r\n\r\n        For the lean control subjects:\r\n\r\n        Inclusion Criteria:\r\n\r\n          1. BMI 18-27 kg/m2\r\n\r\n          2. Fasting plasma glucose 6.1 mmol/L\r\n\r\n          3. Normal values in 2-hour oral glucose tolerance test\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Metal objects in the body (including pacemakers, metallic artificial valve prostheses,\r\n             inner ear implants, surgical clips, braces, foreign fragments)\r\n\r\n          2. Previous participation in PET studies\r\n\r\n          3. Pregnancy\r\n\r\n          4. Poor compliance, alcohol or drug abuse\r\n\r\n          5. Smoking\r\n\r\n          6. History of eating disorders, drastic weight-gain or weight-loss\r\n\r\n          7. History of psychiatric disorders\r\n\r\n          8. Any chronic disease, medication or condition that could create a hazard to subject\r\n             safety, endanger study procedures or interfere with the interpretation of results\r\n      ","sponsor":"Turku University Hospital","sponsor_type":"Other","conditions":"Morbid Obesity","interventions":[{"intervention_type":"Procedure","name":"Procedure: Bariatric Surgery (RYGB or LSG)","description":"Morbidly obese subjects will receive either RYGB or LSG, and the effect of bariatric surgery-induced weight loss on brain inflammation will be assessed"}],"outcomes":[{"outcome_type":"primary","measure":"Obese have brain inflammation compared to healthy ones","time_frame":"Both groups at baseline","description":"Brain PET-[11C]-PK11195 imaging study of obese and healthy lean ones"},{"outcome_type":"primary","measure":"Bariatric surgery decreases brain inflammation in obesity","time_frame":"Baseline and 6 months after operation (obese group only)","description":"PK11195 imaging results are compared before and 6 months after bariatric surgery in obese group studied before and after bariatric surgery"},{"outcome_type":"secondary","measure":"Tissue-specific and whole-body insulin sensitivity are decreased in obese","time_frame":"Baseline obese and leans","description":"Glucose uptakes are measured using PET imaging in obese and leans"},{"outcome_type":"secondary","measure":"Tissue-specific and whole-body glucose improves after bariatric surgery","time_frame":"PET imaging studies at baseline and 6 months after operation","description":"Comparison before and 6 months after surgery (obese group)"},{"outcome_type":"secondary","measure":"Brain neural activity decreased in obesity","time_frame":"Baseline obese and leans","description":"Comparison between obese and lean ones using fMRI"},{"outcome_type":"secondary","measure":"Brain neural activity improves after bariatric surgery","time_frame":"Baseline and 6 months after operation (obese group)","description":"Comparison between obese baseline and 6 months after operation"},{"outcome_type":"secondary","measure":"Brain metabolite concentrations are different in obese","time_frame":"Baseline obese and leans","description":"MRS studies for obese and lean ones at baseline are compared"},{"outcome_type":"secondary","measure":"Brain metabolite concentrations normalize after bariatric surgery","time_frame":"Baseline and 6 months postop (obese group)","description":"MRS studies for obese before and 6 months postop compared"}]}
{"nct_id":"NCT03735563","start_date":"2019-02-11","phase":"Phase 4","enrollment":40,"brief_title":"Premedication for Less Invasive Surfactant Administration","official_title":"Premedication for Less Invasive Surfactant Administration","primary_completion_date":"2022-10-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-10-31","last_update":"2020-12-02","description":"Early respiratory management of preterm infants immediately after birth should be as gentle as possible. With this so-called developmental approach, unnecessary invasive methods can be avoided or at least postponed. This kind of \"soft landing\" allows cardiorespiratory transition with fewer adverse outcomes. Less invasive surfactant administration (LISA) is a technique that involves delivery of surfactant to a spontaneously breathing infant through a thin catheter. This technique minimizes the risk for neonatal lung injury caused by positive pressure ventilation. LISA is nowadays widely used in neonatal intensive care units (NICU). Although less invasive, newborns exposed to this procedure need premedication prior the procedure. There is no consensus, which drug would be the optimal premedication for LISA and the research on this topic is lacking. An ideal premedication would treat the procedural pain without suppressing the infant's own breathing. The sedation and analgesia should start fast but the effect should be short-acting with as few adverse effects as possible. The aim of this randomized, controlled trial (RCT) is to evaluate the feasibility, efficacy and safety of LISA protocol with the premedication of either ketamine or fentanyl by investigating whether one or the other is associated with lower rate of adverse events, hence would be preferred choice for premedication protocol.","other_id":"OY062018","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Gestational age at birth 26 weeks\r\n\r\n          -  Respiratory insufficiency managed with non-invasive respiratory support (nasal\r\n             continuous positive airway pressure or high-flow)\r\n\r\n          -  Requirement for oxygen to maintain oxygen saturation in the target range and need for\r\n             surfactant treatment (according to clinician's assessment)\r\n\r\n          -  If further doses of surfactant are needed, patient can be re-randomized\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Severe RDS with high oxygen requirements, severe respiratory acidosis and/or\r\n             widespread atelectasis radiologically, such that ongoing ventilator support will be\r\n             necessary after surfactant therapy (intubation in preferable to LISA if FiO2 >40% at\r\n             GA <28 weeks and >60% at GA 28 weeks)\r\n\r\n          -  Maxillo-facial, tracheal or known pulmonary malformations\r\n\r\n          -  Any known chromosomal abnormality or severe malformation\r\n\r\n          -  An alternative cause for respiratory distress (e.g. congenital pneumonia or pulmonary\r\n             hypoplasia)\r\n      ","sponsor":"University of Oulu","sponsor_type":"Other","conditions":"Surfactant Deficiency Syndrome Neonatal","interventions":[{"intervention_type":"Drug","name":"Drug: Ketamine","description":"Individuals will receive randomly either ketamine or fentanyl as a premedication"},{"intervention_type":"Drug","name":"Drug: Fentanyl","description":"Individuals will receive randomly either ketamine or fentanyl as a premedication"}],"outcomes":[{"outcome_type":"primary","measure":"Adverse event","time_frame":"1 hour","description":"The need of positive pressure ventilation (PPV), intubation, heart rate below 80 per minute, mean arterial pressure change more than 20%, pH change more than 0.4, and CO2 change more than 20%, and saturation <85 for more than 1 minute"},{"outcome_type":"secondary","measure":"Duration of the procedure","time_frame":"1 hour","description":"Duration of the procedure is evaluated retrospectively from the recording of the videolaryngoscopy (an attempt begins when the laryngoscope enters the mouth and ends with LISACath in the trachea)"},{"outcome_type":"secondary","measure":"Number of attempts to get the catether intratracheally","time_frame":"1 hour","description":"Number of attempts to get the catether intratracheally is evaluated retrospectively from the recording of the videolaryngoscopy (one laryngoscopy = one attempt)"},{"outcome_type":"secondary","measure":"Pain score NIAPAS","time_frame":"1 hour","description":"Pain will be scored with validated Neonatal Infant Acute Pain Assessment Scale (NIAPAS) tool. The scale includes five behavioral and three physiological indicators, and takes into account the gestational age of neonates as a contextual factor. The indicators are rated on a 2, 3, or 4-point scale for a possible total score of 18. Assessments of each neonate include alertness, facial expressions, crying, muscle tension, reaction to handling, and breathing. In addition, the neonates on monitors are assessed for changes in heart rate and oxygen saturation (Copyright Pölkki T, Korhonen A, Axelin A. 2013)"},{"outcome_type":"secondary","measure":"The need for additional dosing of study drug or midazolam (number of addtional dosages)","time_frame":"1 hour","description":"If the study drug does not have sufficient effect, the study drug may be repeated with the same dose. If study drug fails to give appropriate conditions to LISA procedure, midazolam 0,1 mg/kg can be used as an additional drug."},{"outcome_type":"secondary","measure":"Edi-signals","time_frame":"1 hour","description":"Special Edi (Electronic Diaphragm Monitoring) Catheter is placed to read the electrical activity of the diaphragm. Edi min and Edi max in different time points will be collected."}]}
{"nct_id":"NCT03593473","start_date":"2019-02-07","phase":"Phase 2","enrollment":150,"brief_title":"Inhaled Oxytocin and HPA Axis Reactivity","official_title":"The Psychobiology of Resilience in Mother-child Pairs: Inhaled Oxytocin and HPA Axis Reactivity","primary_completion_date":"2022-05-31","study_type":"Interventional","rec_status":"Enrolling by invitation","completion_date":"2022-06-30","last_update":"2020-08-12","description":"Mothers who were enrolled in the Mood, Mother and Infant study will be eligible to participate in the 6-year follow-up maternal visit. At the time of this visit, mothers will be randomized to a single 24 IU dose of nasal oxytocin or placebo. Following administration of the study drug, women will participate in the Trier Social Stress Test (TSST), and blood samples will be collected to quantify HPA axis reactivity.","other_id":"12-2061","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"Quadruple","intervention_model_description":"Non-pregnant women will be randomized to either 24 IU of nasal OT or placebo. The Investigational Drug Service will use a random number generator to prepare a randomization table.","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        This study will follow-up the existing Mood, Mother and Infant (MMI) prospective\r\n        longitudinal cohort (R01HD073220), comprised of 222 mother-infant dyads who were recruited\r\n        between May 2013 and April 2017 and completed the 12-month MMI visit. In the MMI study, 222\r\n        mothers ages 18-45 and their infants were enrolled. Participants were recruited from\r\n        community clinics in the third trimester of pregnancy and continued to participate in the\r\n        study through 12 months postpartum. At the 12-month visit, mothers were invited to continue\r\n        to be followed via online surveys at 6-month intervals; more than 80% of women who have\r\n        completed the MMI study to date have continued to participate. Enrolled participants in the\r\n        MMI study met the following inclusion and exclusion criteria:\r\n\r\n        Inclusion Criteria:\r\n\r\n          1. Singleton pregnancy;\r\n\r\n          2. Intention to breastfeed (due to the centrality of breastfeeding to the oxytocin\r\n             assessment);\r\n\r\n          3. Intention to remain within 40 miles of the University of North Carolina - Chapel Hill\r\n             through infant's first birthday;\r\n\r\n          4. Ability to communicate in English.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Maternal diagnosis of Axis I disorders other than unipolar depression or anxiety\r\n             disorders. Women with a history of bipolar disorder were excluded, given their\r\n             increased risk of postpartum psychosis.\r\n\r\n          2. Active substance abuse at enrollment in the 3rd trimester of pregnancy (Tobacco,\r\n             alcohol, illicits);\r\n\r\n          3. Major congenital anomaly;\r\n\r\n          4. Chronic medication/medical condition contraindicated for breastfeeding;\r\n\r\n          5. Current use of tricyclic antidepressants, which alter cortisol and heart rate\r\n             variability.\r\n\r\n        At enrollment, all participants underwent a Structured Clinical Interview Non-Patient\r\n        version (SCID-NP).\r\n\r\n        Inclusion Criteria for Inhaled Oxytocin and HPA Axis Reactivity, a substudy of the\r\n        Psychobiology of Resilience in Mother-Child Pairs follow-up study: 1) Participated in the\r\n        MMI study 2) Both mother and child willing and able to participate in the 6-year follow-up\r\n        visits 3) Not pregnant, verified by urine pregnancy test on day of study visit.\r\n      ","sponsor":"University of North Carolina, Chapel Hill","sponsor_type":"Other","conditions":"Depression, Postpartum|Anxiety Disorders|Stress, Psychological","interventions":[{"intervention_type":"Drug","name":"Drug: Intranasal Oxytocin","description":"Six intranasal sprays of oxytocin. Each insufflation delivers 4 IUs of oxytocin for a total oxytocin dosage of 24 IUs."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Six intranasal sprays of placebo manufactured to mimic oxytocin nasal spray containing all equivalent ingredients except oxytocin."}],"outcomes":[{"outcome_type":"primary","measure":"Changes in Cortisol (CRT) during Trier Social Stress Test (TSST)","time_frame":"-40 minutes, -20 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutes, +48 minutes","description":"The study drug will be administered 40 minutes before the TSST. Serum cortisol and Adrenocorticotropic hormone will be measured via peripheral IV 30 minutes before the TSST (-30), at the start of the TSST (0 minutes), and at minutes 10 (during the speech task), 15 (during the math task), 28 and 38 (during recovery)."},{"outcome_type":"secondary","measure":"Changes in Adrenocorticotropic hormone (ACTH ) during TSST","time_frame":"-40 minutes, -20 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutes, +48 minutes","description":"The study drug will be administered 40 minutes before the TSST. Serum cortisol and Adrenocorticotropic hormone will be measured via peripheral IV 30 minutes before the TSST (-30), at the start of the TSST (0 minutes), and at minutes 10 (during the speech task), 15 (during the math task), 28 and 38 (during recovery)."},{"outcome_type":"secondary","measure":"Changes in the lagged association between ACTH and CRT during the TSST","time_frame":"ACTH at -40 minutes, -20 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutes and Cortisol at -20 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutes, +48 minutes","description":"Correlations will be quantified between ACTH at time j and CRT at time j+1 to test the extent to which CRT response is blunted by exogenous OT."},{"outcome_type":"secondary","measure":"Changes in high frequency heart rate variability, an index of parasympathetic activity, during the TSST","time_frame":"Minutes -40 to -35, -35 to -30, -30 to -25, -25 to -20, -20 to -15, -15 to -10, -10 to -5, -5 to 0, 0 to 5, 5 to 8, 8 to 13, 13 to 18, 18 to 23, 23 to 28, 28 to 33, 33 to 38, 38 to 43, 43 to 48","description":"Recording of autonomic activity beginning prior to study drug administration (-40 minutes) until the end of recovery from the TSST (+38 minutes). Mobile Impedance Cardiographs (MindWare Tech Ltd, Gahanna, OH) will be used to measure cardiac rate and interbeat interval (IBI). MindWare Heart Rate Variability (HRV) software will be used to derive respiration and to calculate high frequency HRV and respiratory sinus arrhythmia from the IBI series as indices of parasympathetic activity."},{"outcome_type":"secondary","measure":"Changes in pre-ejection period, an index of sympathetic activity, during the TSST","time_frame":"Minutes -40 to -35, -35 to -30, -30 to -25, -25 to -20, -20 to -15, -15 to -10, -10 to -5, -5 to 0, 0 to 5, 5 to 8, 8 to 13, 13 to 18, 18 to 23, 23 to 28, 28 to 33, 33 to 38, 38 to 43, 43 to 48","description":"Recording of autonomic activity beginning prior to study drug administration (-40 minutes) until the end of recovery from the TSST (+38 minutes). Mobile Impedance Cardiographs (MindWare Tech Ltd, Gahanna, OH) will be used to measure pre-ejection period (PEP). PEP will index sympathetic activation."},{"outcome_type":"other","measure":"Assessment of effect modification by maternal depression / anxiety on changes in Cortisol (CRT) during Trier Social Stress Test (TSST)","time_frame":"-40 minutes, -20 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutes, +48 minutes","description":"Stratified analyses will be performed to determine the extent to which maternal depression/anxiety modifies the effect of OT/placebo on CRT during the TSST."},{"outcome_type":"other","measure":"Assessment of effect modification by maternal depression / anxiety on changes in Adrenocorticotropic hormone (ACTH ) during TSST","time_frame":"-40 minutes, -20 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutes, +48 minutes","description":"Stratified analyses will be performed to determine the extent to which maternal depression/anxiety modifies the effect of OT/placebo on ACTH during the TSST."},{"outcome_type":"other","measure":"Assessment of effect modification by maternal depression / anxiety on changes in high frequency heart rate variability, an index of parasympathetic activity, during the TSST","time_frame":"Minutes -40 to -35, -35 to -30, -30 to -25, -25 to -20, -20 to -15, -15 to -10, -10 to -5, -5 to 0, 0 to 5, 5 to 8, 8 to 13, 13 to 18, 18 to 23, 23 to 28, 28 to 33, 33 to 38, 38 to 43, 43 to 48","description":"Stratified analyses will be performed to determine the extent to which maternal depression/anxiety modifies the effect of OT/placebo on parasympathetic activity during the TSST."},{"outcome_type":"other","measure":"Assessment of effect modification by maternal depression / anxiety on changes in pre-ejection period, an index of sympathetic activity, during the TSST","time_frame":"Minutes -40 to -35, -35 to -30, -30 to -25, -25 to -20, -20 to -15, -15 to -10, -10 to -5, -5 to 0, 0 to 5, 5 to 8, 8 to 13, 13 to 18, 18 to 23, 23 to 28, 28 to 33, 33 to 38, 38 to 43, 43 to 48","description":"Stratified analyses will be performed to determine the extent to which maternal depression/anxiety modifies the effect of OT/placebo on sympathetic activity during the TSST."},{"outcome_type":"other","measure":"Assessment of effect modification by OXTR genotype on changes in Cortisol (CRT) during Trier Social Stress Test (TSST)","time_frame":"-40 minutes, -20 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutes, +48 minutes","description":"Stratified analyses will be performed to determine the extent to which maternal depression/anxiety modifies the effect of OT/placebo on CRT during the TSST."},{"outcome_type":"other","measure":"Assessment of effect modification by OXTR genotype on changes in Adrenocorticotropic hormone (ACTH ) during TSST","time_frame":"-30 minutes, 0 minutes, +10 minutes, +15 minutes, +28 minutes, +38 minutes","description":"Stratified analyses will be performed to determine the extent to which maternal depression/anxiety modifies the effect of OT/placebo on ACTH during the TSST."},{"outcome_type":"other","measure":"Assessment of effect modification by OXTR genotype changes in high frequency heart rate variability, an index of parasympathetic activity, during the TSST","time_frame":"Minutes -40 to -35, -35 to -30, -30 to -25, -25 to -20, -20 to -15, -15 to -10, -10 to -5, -5 to 0, 0 to 5, 5 to 8, 8 to 13, 13 to 18, 18 to 23, 23 to 28, 28 to 33, 33 to 38, 38 to 43, 43 to 48","description":"Stratified analyses will be performed to determine the extent to which maternal depression/anxiety modifies the effect of OT/placebo on parasympathetic activity during the TSST."},{"outcome_type":"other","measure":"Assessment of effect modification by OXTR genotype on changes in pre-ejection period, an index of sympathetic activity, during the TSST","time_frame":"Minutes -40 to -35, -35 to -30, -30 to -25, -25 to -20, -20 to -15, -15 to -10, -10 to -5, -5 to 0, 0 to 5, 5 to 8, 8 to 13, 13 to 18, 18 to 23, 23 to 28, 28 to 33, 33 to 38, 38 to 43, 43 to 48","description":"Stratified analyses will be performed to determine the extent to which maternal depression/anxiety modifies the effect of OT/placebo on sympathetic activity during the TSST."}]}
{"nct_id":"NCT03501966","start_date":"2019-02-06","phase":"Phase 3","enrollment":16,"brief_title":"Surgical Idiopathic Intracranial Hypertension Treatment Trial","official_title":"Randomized Trial of Medical Therapy (MT) vs. MT Plus Optic Nerve Sheath Fenestration vs. MT Plus Ventriculoperitoneal Cerebrospinal Fluid Shunting in Subjects With Idiopathic Intracranial Hypertension and Moderate to Severe Visual Loss","primary_completion_date":"2019-08-28","study_type":"Interventional","rec_status":"Terminated","completion_date":"2019-08-28","last_update":"2020-02-11","description":"Randomized trial of adults (18 years old) with idiopathic intracranial hypertension and moderate to severe visual loss without substantial recent treatment who are randomly assigned to (1) medical therapy, (2) medical therapy plus ONSF, or (3) medical therapy plus VPS. The primary outcome is visual field mean deviation change at first of Month 6 (26 weeks) or time of treatment failure of the eligible eye(s), followed by a continuation study to assess time to treatment failure. The determination of eligible eye(s) is based on meeting the eligibility criteria at baseline.","other_id":"SIGHT","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","intervention_model_description":"Subjects will be randomly assigned with equal allocation to one of the three treatment groups. Using a permuted block design, randomization will be stratified by PMD (average of 2 size V stimulus tests) in the eligible eye(s) (-6 dB to >-12 dB; -12 dB to >-20 dB; -20 dB to -27 dB). If a subject has two eligible eyes, the average PMD of the two eyes will be used for stratification.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":63,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subject Eligibility Criteria Inclusion Criteria\r\n\r\n               1. Diagnosis of IIH by modified Dandy criteria (Table 4)\r\n\r\n               2. Age 18 to <64 years at time of consent\r\n\r\n               3. Age 18 to <61 years at time of diagnosis (time of diagnosis is the time at which\r\n                  the patient meets the modified Dandy criteria, usually after the lumbar puncture\r\n                  results are reviewed)\r\n\r\n               4. Presence of bilateral papilledema\r\n\r\n               5. Lumbar puncture within 6 weeks of screening visit or completed as part of\r\n                  screening: Opening CSF pressure >250 mmH2O or 200 to 250 mmH2O with at least one\r\n                  of the following:\r\n\r\n                    -  Pulse synchronous tinnitus\r\n\r\n                    -  Cranial nerve VI palsy\r\n\r\n                    -  Echography for disc drusen negative and no other disc anomalies mimicking\r\n                       disc edema present\r\n\r\n                    -  Magnetic Resonance Venography (MRV) with lateral sinus collapse/stenosis,\r\n                       partially empty sella turcica on coronal or sagittal views of MRI, and optic\r\n                       nerve sheaths with filled out CSF spaces next to the globe on T2 weighted\r\n                       axial MRI scans If the patient was treated with intracranial pressure\r\n                       lowering agents (e.g., acetazolamide) prior to obtaining a lumbar puncture,\r\n                       the agent(s) must be discontinued for at least 24 hours prior to performing\r\n                       the diagnostic lumbar puncture.\r\n\r\n               6. At least one eye meeting all eligible eye inclusion criteria and no exclusion\r\n                  criteria.\r\n\r\n               7. Able to provide informed consent\r\n\r\n               8. Investigator believes participant is a good candidate for the study, including\r\n                  the probability of returning for follow-up.\r\n\r\n          -  Eye-Level Eligibility Criteria Subjects must have at least one eye meeting all of the\r\n             inclusion criteria and none of the exclusion criteria.\r\n\r\n        If both eyes meet eligibility criteria at the baseline examination, both will be included\r\n        in the primary outcome analysis.\r\n\r\n        Inclusion\r\n\r\n          1. Visual field loss meeting the following criteria based on two full threshold 24-2 size\r\n             V tests reviewed by the VFRC:\r\n\r\n               -  PMD from -6 decibel (dB) to -27 dB\r\n\r\n               -  Reproducible visual loss present on automated perimetry including no more than\r\n                  15% false positive response\r\n\r\n          2. Visual acuity better than 20/200 (39 or more letters correct)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subject Exclusion Criteria Exclusion Criteria\r\n\r\n               1. Treatment of IIH within the past 3 months with either (1) the maximally tolerated\r\n                  dosage of acetazolamide for at least one week or (2) more than one month of\r\n                  acetazolamide with a cumulative dosage of more than 45 grams 'Maximally-tolerated\r\n                  dose' is defined as dosage was reached where dosage could not be increased\r\n                  further either because of side effects or because a daily total dosage of 4 grams\r\n                  per day was reached.\r\n\r\n                  If individual discontinued acetazolamide in the past due to side effects,\r\n                  individual is only eligible if investigator believes that the individual is\r\n                  likely to tolerate acetazolamide, as it will be prescribed in the study.\r\n\r\n               2. Treatment of IIH within the past 3 months with either (1) the maximally tolerated\r\n                  dosage of methazolamide for at least one week or (2) more than one month of\r\n                  methazolamide with a cumulative dosage of more than 4.5 grams\r\n                  'Maximally-tolerated dose' is defined as dosage was reached where dosage could\r\n                  not be increased further either because of side effects or because a daily total\r\n                  dosage of 400 mg per day was reached.\r\n\r\n               3. Treatment with topiramate within two months and average cumulative dosage for the\r\n                  preceding month of more than 700 mg per week\r\n\r\n               4. Previous surgery for IIH, including ONSF, CSF shunting, subtemporal\r\n                  decompression, or venous sinus stenting; gastric surgery for obesity is allowed\r\n\r\n               5. Abnormalities on neurologic examination except for papilledema and its related\r\n                  visual loss or cranial nerve VI to VII paresis; if other abnormalities are\r\n                  present, the patient will need to be discussed with the Study Director (SD) for\r\n                  study entry.\r\n\r\n               6. Abnormal CT or MRI scan (intracranial mass, hydrocephalus, dural sinus thrombus,\r\n                  or arteriovenous malformation) other than findings known to occur with increased\r\n                  intracranial pressure. Abnormalities on MRI that are not known to cause increased\r\n                  intracranial pressure are acceptable.\r\n\r\n               7. Abnormal CSF contents: increased cells: > 8 cells; elevated protein: > 45 mg%;\r\n                  low glucose: < 30 mg% (If the lumbar puncture produces a cell count compatible\r\n                  with a traumatic needle insertion, the patient does not need to be excluded if\r\n                  the CSF white blood cell count (WBC) after correction is 8 cells/mm3 or less -\r\n                  see Manual of Procedures (MOP) for calculation. If > 8 cells or > 45mg% in CSF\r\n                  protein are documented in the CSF or calculated after conversion from a traumatic\r\n                  lumbar puncture, the patient can be discussed with the Study Director for\r\n                  possible inclusion.)\r\n\r\n               8. Abnormal blood work-up indicating a medical or systemic condition associated with\r\n                  raised intracranial pressure\r\n\r\n               9. Diabetes mellitus with diabetic retinopathy\r\n\r\n              10. Ingestion of a drug or substance, or presence of a disorder, that has been\r\n                  associated with increased intracranial pressure within 2 months of diagnosis,\r\n                  such as lithium, vitamin A related products (e.g., Retin-A), or various cyclines\r\n                  (see MOP for conditions and drugs)\r\n\r\n              11. Laboratory test results showing severe anemia, leukopenia or thrombocytopenia,\r\n                  renal failure, or hepatic disease, based on the Site Investigator's judgment\r\n\r\n              12. Other condition requiring continued use of oral, I.V. or injectable steroids\r\n                  (nasal, inhaled, or topical steroids are allowed since the systemic effects are\r\n                  small). Patients with a condition that resulted in recent or current use of\r\n                  steroids but may be safely tapered off will be handled on a case-by-case basis\r\n                  after discussion with Study Director/co-Director. See Manual of Procedures (MOP)\r\n                  for details.\r\n\r\n              13. Presence of a medical condition that would contraindicate use of acetazolamide or\r\n                  furosemide or significantly increase surgical risk\r\n\r\n              14. Pregnancy or unwillingness for a subject of childbearing potential to use\r\n                  contraception during the first 6 months of the study Women of childbearing\r\n                  potential must use an acceptable form of birth control during the first 6 months\r\n                  of the study. Acceptable forms include oral contraceptives, transdermal\r\n                  contraceptives, diaphragm, intrauterine devices (IUDs), condoms with spermicide,\r\n                  documented surgical sterilization of either the subject or their partner, or\r\n                  abstinence.\r\n\r\n              15. Presence of a physical, mental, or social condition likely to affect follow-up\r\n                  (drug addiction, terminal illness, no telephone, homeless)\r\n\r\n              16. Anticipation of a move from the site area within six months and unwillingness to\r\n                  return for follow-up at a SIGHT study site\r\n\r\n              17. Allergy to pupil dilating drops or narrow angles precluding safe dilation\r\n\r\n              18. Presence of a condition that contraindicates general anesthesia\r\n\r\n              19. Participation in an investigational trial within 30 days of enrollment that\r\n                  involved treatment with any systemic drug therapy or therapy that affects the\r\n                  eligible eye(s)\r\n\r\n          -  Eye Level Exclusion Criteria Exclusion\r\n\r\n               1. Intraocular pressure currently >28 mm Hg or >30 mm Hg at any time in the past\r\n\r\n               2. Refractive error of more than -6.00 or more than +6.00 sphere or more than 3.00\r\n                  cylinder with the following exceptions:\r\n\r\n                    -  Eyes with more than 6.00 D of myopia but less than 8.00 D of myopia are\r\n                       eligible if: 1) there are no abnormalities on ophthalmoscopy related to\r\n                       myopia that are associated with visual loss (such as staphyloma, retinal\r\n                       thinning in the posterior pole, or more than mild optic disc tilt), and 2)\r\n                       the individual will wear a contact lens for all perimetry examinations with\r\n                       the appropriate correction.\r\n\r\n                    -  Eyes with more than 6.00 D of hyperopia but less than 8.00 D of hyperopia\r\n                       are eligible if: 1) there is an unambiguous characteristic halo of\r\n                       peripapillary edema as opposed to features of a small crowded disc or other\r\n                       hyperopic change related to visual loss determined by the Site Investigator\r\n                       or the Photographic Reading Center (PRC) Director (or his designate), and 2)\r\n                       the individual will wear a contact lens for all perimetry examinations with\r\n                       the appropriate correction (which can be corrected for perimetry or with the\r\n                       patient's own contact lens with over correction by lens at the perimeter).\r\n\r\n                  Note: Refractive error exclusion and exceptions refer to sphere not spherical\r\n                  equivalent, with cylinder expressed in plus format.\r\n\r\n               3. Other disorders causing visual loss except for refractive error and amblyopia,\r\n                  including cells in the vitreous or iritis\r\n\r\n               4. Large optic disc drusen on exam or known in previous history (small drusen of the\r\n                  disc can occur with longstanding papilledema and are allowed if not so numerous\r\n                  that investigator determines they are contributing to vision loss)\r\n      ","sponsor":"Jaeb Center for Health Research","sponsor_type":"Other","conditions":"Idiopathic Intracranial Hypertension","interventions":[{"intervention_type":"Drug","name":"Drug: Acetazolamide","description":"Medical therapy including diet"},{"intervention_type":"Procedure","name":"Procedure: Optic Nerve Sheath Fenestration","description":"Medical therapy including diet + optic nerve sheath fenestration"},{"intervention_type":"Procedure","name":"Procedure: Ventriculoperitoneal CSF Shunting","description":"Medical therapy including diet + ventriculoperitoneal CSF Shunting"}],"outcomes":[{"outcome_type":"primary","measure":"Perimetric Mean Deviation (PMD)","time_frame":"6 months","description":"Change from baseline to first of Month 6 (Week 26) or time of treatment failure in PMD (perimetric mean deviation) in eligible eye(s) with the size V stimulus"},{"outcome_type":"secondary","measure":"Treatment Failure","time_frame":"up to 3 years","description":"Time from randomization to treatment failure"},{"outcome_type":"secondary","measure":"Cerebrospinal Fluid (CSF) Opening Pressure","time_frame":"6 months","description":"Change in CSF opening pressure measurement by lumbar puncture"},{"outcome_type":"secondary","measure":"Papilledema Grade","time_frame":"6 months","description":"Change in papilledema grade"},{"outcome_type":"secondary","measure":"OCT Retinal Nerve Fiber Layer Thickness","time_frame":"6 months","description":"Change in retinal nerve fiber layer thickness"},{"outcome_type":"secondary","measure":"OCT Total retinal thickness","time_frame":"6 months","description":"Change in total retinal thickness"},{"outcome_type":"secondary","measure":"Visual Acuity (VA) using Early Treatment Diabetic Retinopathy Study (ETDRS) chart","time_frame":"6 months","description":"Change in VA scores, determined by baseline VA of better than 20/200 (39 or more letters correct) and worsening indicated by less correct letters"},{"outcome_type":"secondary","measure":"Quality of Life (QoL) 36 Item Short Form Health Survey (SF-36v2)","time_frame":"6 months","description":"Changes in QoL as measured by responses"},{"outcome_type":"secondary","measure":"Quality of Life (QoL) Visual Function Questionnaire (VFQ-25)","time_frame":"6 months","description":"Changes in QoL as measured by responses"},{"outcome_type":"secondary","measure":"Quality of Life (QoL) 10-item neuro-ophthalmic supplement to the VFQ-25","time_frame":"6 months","description":"Changes in QoL as measured by responses"},{"outcome_type":"secondary","measure":"Headaches","time_frame":"6 months","description":"Headache Impact Test (HIT-6) Inventory"}]}
{"nct_id":"NCT03805685","start_date":"2019-02-03","enrollment":38,"brief_title":"Preoperative Risk Factors and Perioperative Neurocognitive Disorders","official_title":"The Influence of Preoperative Risk Factors on Perioperative Neurocognitive Disorders in Patients Scheduled for Non-cardiac Surgery","primary_completion_date":"2019-09-25","study_type":"Observational","rec_status":"Completed","completion_date":"2019-10-30","last_update":"2019-12-24","description":"Perioperative neurocognitive disorders (PND's) remain an important complication after surgery. After many years of speculating about the etiology of this complication, currently studies are pointing to an inflammatory cascade being set in motion. This prospective study is designed to examine preoperative lifestyle factors (such as sedentary behavior) associated with postoperative cognitive impairment in a group of patients undergoing non-cardiac surgery. The objectives in our study are to: identify perioperative risk factors for the development of PND's measure the incidence and duration of perioperative neurocognitive disorders in a known high-risk group of elective surgical patients measure a peripheral inflammatory marker (interleukin 6: IL-6) in the same group of surgical patients","other_id":"Lifestyle-Delirium","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":55,"maximum_age":75,"population":"All patients participating in the study will have to provide written informed consent.\r\n        Patients of both genders aged 55 or more scheduled for non-cardiac surgery between 8 and 10\r\n        AM (with a duration of 1 to 4 hours) will be eligible for enrolment in the study.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Signed written consent\r\n\r\n          -  Patients scheduled for non-cardiac surgery (with a duration of 1 to 4 hours)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Lack of comprehension of the French, English or Dutch language\r\n\r\n          -  Visual or auditory impairment\r\n\r\n          -  Any other reason that makes patients unable to perform cognitive testing\r\n      ","sponsor":"Universit Libre de Bruxelles","sponsor_type":"Other","conditions":"Cognitive Change","interventions":[{"intervention_type":"Procedure","name":"Procedure: Non-Cardiac Surgery","description":"Non-cardiac surgery"}],"outcomes":[{"outcome_type":"primary","measure":"Pre-operative MMSE","time_frame":"12 hours","description":"Mini mental state examination will be evaluated prior to the surgery"},{"outcome_type":"primary","measure":"MMSE 6 weeks post-operative","time_frame":"6 weeks","description":"Mini mental state examination will be evaluated 6 weeks after surgery"},{"outcome_type":"primary","measure":"MMSE 3 months post-operative","time_frame":"3 months","description":"Mini mental state examination will be evaluated 3 months after surgery"},{"outcome_type":"secondary","measure":"Concentration of patient's baseline pre-operative peripheral IL-6","time_frame":"12 hours","description":"Blood samples to measure IL-6 will be drawn prior to the surgery"},{"outcome_type":"secondary","measure":"Concentration of patient's post-operative peripheral IL-6; 6 hours post-operative","time_frame":"24 hours","description":"Blood samples to measure IL-6 will be drawn 6 hours after the surgery"},{"outcome_type":"secondary","measure":"Concentration of patient's post-operative peripheral IL-6 ; 24 hours post-operative","time_frame":"24 hours","description":"Blood samples to measure IL-6 will be drawn 24 hours after the surgery"}]}
{"nct_id":"NCT02436902","start_date":"2019-02-01","phase":"Phase 3","enrollment":240,"brief_title":"Adjuvant Therapies for Patients With HCC and MVI","official_title":"Adjuvant Transarterial Chemoembolization With or Without Sorafenib for Patients With Hepatocellular Carcinoma and Microvascular Invasion","primary_completion_date":"2022-08-23","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-08-30","last_update":"2020-01-10","description":"Hepatocellular carcinoma (HCC) is a common malignancy, and its incidence is expected to increase in many countries in coming decades. Though prognosis for patients with HCC is generally poor, hepatic resection can be an effective curative treatment, and its indications have been expanding in recent years. Resection can be reasonably safe and effective even for patients with micro- or macrovascular invasion. However, the recurrence rate of HCC is as high as 74% for patients with intermediate and advanced HCC after resection. Microvascular invasion is one of the main risk factors which influence risk of HCC recurrence and patient prognosis after resection. Therefore, adjuvant therapy to prevent tumor recurrence after resection is so important to improve patient prognosis. Nowadays, adjuvant transarterial chemoembolization (TACE) is reported to be effective in reducing early recurrence rate and mortality for patients with HCC with risk factors of recurrence. Sorafenib is a novel drug which is effective for advanced stage HCC. However, the efficacy of adjuvant sorafenib for postoperative HCC is unknown. Therefore, it is interesting to investigate the efficacy of adjuvant sorafenib, and compare its efficacy to TACE, TACE plus sorafenib, or best supportive care for patients with postoperative HCC and microvascular invasion.","other_id":"A-TACE/S-HCC","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age 18-75 years\r\n\r\n          -  Diagnosis of HCC was confirmed by histopathological examination of surgical samples in\r\n             all patients\r\n\r\n          -  Patients with microvascular invasion by histopathological examination of surgical\r\n             samples\r\n\r\n          -  Patients have Child-Pugh A or B liver function\r\n\r\n          -  No previous neoadjuvant treatment\r\n\r\n          -  No evidence of macrovascular invasion, metastasis to the lymph nodes and/or distant\r\n             metastases on the basis of preoperative imaging results and perioperative findings\r\n\r\n          -  No malignancy other than HCC for 5 years prior to the initial HCC treatment\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of cardiac disease\r\n\r\n          -  Known history of human immunodeficiency virus (HIV) infection\r\n\r\n          -  Known Central Nervous System tumors including metastatic brain disease\r\n\r\n          -  History of organ allograft\r\n\r\n          -  Substance abuse, medical, psychological or social conditions that may interfere with\r\n             the patient's participation in the study or evaluation of the study results\r\n\r\n          -  Any condition that is unstable or which could jeopardize the safety of the patient and\r\n             his/her compliance in the study\r\n\r\n          -  Pregnant or breast-feeding patients\r\n      ","sponsor":"Guangxi Medical University","sponsor_type":"Other","conditions":"Hepatocellular Carcinoma","interventions":[{"intervention_type":"Procedure","name":"Procedure: TACE","description":"TACE is performed one month after resection."},{"intervention_type":"Drug","name":"Drug: Sorafenib","description":"Sorafenib is submitted one month after resection."},{"intervention_type":"Drug","name":"Drug: TACE plus sorafenib","description":"TACE plus sorafenib will be submitted one month after resection."},{"intervention_type":"Other","name":"Other: empty control","description":"This group will not receive adjuvant therapy."}],"outcomes":[{"outcome_type":"primary","measure":"Overall survivals","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Hospital mortality","time_frame":"30-day"},{"outcome_type":"secondary","measure":"Recurrence rates","time_frame":"1 years"}]}
{"nct_id":"NCT03874273","start_date":"2019-02-01","phase":"Phase 2/Phase 3","enrollment":25,"brief_title":"Study of Crizotinib in Children and Adolescents With Myofibroblastic Tumors","official_title":"Targeted Therapy in Children and Adolescents With Recurrent, Progressive and Unresectable Inflammatory Myofibroblastic Tumor With the Inhibitor of Tyrosine Kinase -Crizotinib","primary_completion_date":"2021-02-01","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2021-03-01","last_update":"2019-03-14","description":"Targeted therapy based on target identification by genetic examinations is a promising direction in the treatment of patients with a complicated course of inflammatory myofibroblastic tumor. Recently, the main work covered in foreign publications, aimed at finding additional methods of treatment, by identifying new targets for targeted therapy in patients with unresectable IMT, but currently there is no standardized approach to the treatment of IMT in children worldwide. This study can show the benefits of the usage of crizotinib as targeted therapy in children with ALK/ROS1 positive unresectable, progressive or reccurent inflammatory myofibroblastic tumors. The main hypothesis is that crizotinib would increase an objective response rate in this group of patients.","other_id":"NCPHOI-2019-01","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","maximum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age 0 - 18 years\r\n\r\n          -  The presence of a histologically verified diagnosis of Inflammatoru Myofibroblastic\r\n             Tumor, confirmed in the pathology laboratory of Dmitry Rogachev National Research\r\n             Center\r\n\r\n          -  The presence of ttumor masses according to CT or MRI at the time of inclusion in the\r\n             protocol\r\n\r\n          -  Unresectable or metastatic tumor\r\n\r\n          -  Relapse or progressive disease\r\n\r\n          -  Good perfomance status\r\n\r\n          -  Normal function of bone marrow\r\n\r\n          -  Normal function of a liver\r\n\r\n          -  Normal levels of creatinine and urea in blood\r\n\r\n          -  Nornal heart funtion (LVEF > 60%)\r\n\r\n          -  Clear expression of rearranged ALK/ROS1 genes\r\n\r\n          -  Signed Informed Consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Age >18 years\r\n\r\n          -  Refusal of signing the form of the informed consent\r\n\r\n          -  The presence of comorbidities, which may endanger patient safety\r\n\r\n          -  No rearrangements of ALK/ROS genes\r\n\r\n          -  No signs of existing tumor, according to CT and MRI\r\n      ","sponsor":"Federal Research Institute of Pediatric Hematology, Oncology and Immunology","sponsor_type":"Other","conditions":"Inflammatory Myofibroblastic Tumor","interventions":[{"intervention_type":"Drug","name":"Drug: Crizotinib","description":"Crizotinib 280mg/m2 twice a day (for 24 months maximum)"}],"outcomes":[{"outcome_type":"primary","measure":"Overall response rate","time_frame":"2 months","description":"The frequency of response to therapy with Crizotinib in patients with translocation of the ALK / ROS1 genes and their partners."},{"outcome_type":"secondary","measure":"Relapse-free survival","time_frame":"5 years","description":"Time after treatment without any signs or symptoms of inflammatory myofibroblastic tumor"},{"outcome_type":"secondary","measure":"Overall survival","time_frame":"5 years","description":"The length of time from the start of treatment with crizotinib, that patients diagnosed with the inflammatory myofibroblastic tumor are still alive"}]}
{"nct_id":"NCT04611594","start_date":"2019-02-01","phase":"N/A","enrollment":75,"brief_title":"Fluid Restriction in Patients With Heart Failure","official_title":"Impact of Fluid Restriction in Patients With Pulmonary Congestion After Discharge From an Acute Decompensated Heart Failure Hospitalization: a Randomized Clinical Trial.","primary_completion_date":"2021-02-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-06-01","last_update":"2020-11-02","description":"There is a concept increasingly consolidated by clinical evidence that at each hospitalization due to HF decompensation there is a substantial loss of quality of life, which is associated with an initial period of great clinical vulnerability, with high rates of rehospitalization and an increased risk of death. The non-pharmacological measures that are widely practiced and recommended for HF patients, such as fluid restriction, specially at the first 30 days after hospital discharge, still lack clearer evidence of their therapeutic efficacy.","other_id":"HCPA 2019-0216","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Hospital admission for primary diagnosis of acutely decompensated heart failure,\r\n             regardless of etiology, according to the criteria of the American College of\r\n             Cardiology;\r\n\r\n          -  Diagnosis on echocardiography of heart failure with reduced ejection fraction (<40%);\r\n\r\n          -  Presence of pulmonary congestion defined as at least 2 pulmonary fields with more than\r\n             3 B lines in each field on pulmonary ultrasound at the time of hospital discharge.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pulmonary fibrosis or other severe disease that changes the image acquisition\r\n             (significant pleural effusion, severe pulmonary emphysema, previous pneumectomy or\r\n             lobectomy, primary or metastatic lung cancer, breast implants);\r\n\r\n          -  Pregnancy;\r\n\r\n          -  Dialysis renal failure patient;\r\n\r\n          -  Factors that could hinder follow-up (not returning to the outpatient clinic of\r\n             Hospital de Clnicas);\r\n\r\n          -  Disability or refusing to understand and adhere to the protocol;\r\n\r\n          -  Refusal to sign consent form.\r\n      ","sponsor":"Hospital de Clinicas de Porto Alegre","sponsor_type":"Other","conditions":"Heart Failure, Systolic|Heart Failure; With Decompensation|Pulmonary Congestion","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Fluid restriction","description":"Ingestion of approximately 20 ml / kg of ideal weight,"}],"outcomes":[{"outcome_type":"primary","measure":"N-terminal pro-BNP","time_frame":"30 days","description":"Variation in plasma NT pro-BNP levels (from the day of hospital discharge to approximately 30 days after)."},{"outcome_type":"secondary","measure":"Pulmonary ultrasound","time_frame":"30 days","description":"Variation in the total number of B lines in all lung fields measured by ultrasound (from the day of hospital discharge until approximately 30 days after)."},{"outcome_type":"secondary","measure":"Body weight","time_frame":"30 days","description":"Variation of the patient's weight in kilograms (from the day of hospital discharge until approximately 30 days after)"},{"outcome_type":"secondary","measure":"Major cardiovascular and non-cardiovascular clinical events","time_frame":"30 days","description":"Hospital admissions and death"},{"outcome_type":"secondary","measure":"Multidisciplinary clinical events related to heart failure","time_frame":"30 days","description":"Six minutes walk test"}]}
{"nct_id":"NCT03851900","start_date":"2019-02-01","phase":"N/A","enrollment":50,"brief_title":"A Comparison of Long-Term Effectiveness of Two Desensitizing Products","official_title":"A Comparison of Long-Term Effectiveness of Two Desensitizing Products: A Randomized Clinical Placebo-Controlled Study","primary_completion_date":"2019-10-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-10-01","last_update":"2019-10-03","description":"This randomized, controlled, clinical trial aimed to compare the 6- month clinical performance of a desensitizer that contains calcium phosphate TM with a two-step self-etch adhesive SE and placebo (distilled water). At least 150 teeth wil be treated with desensitizing products and placebo randomly one third usig TM, one third using SE and one third using placebo. The efficiency of the materials will be evaluated at baseline, 1 week, 1 month, 3 months and 6 months after treatment.","other_id":"Hacettepe 2017/06-26 KA-16009","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","intervention_model_description":"For each patient, selected teeth will be randomly assigned to TM, SE or placebo by the lottery method. The subjects will blind to the agent being used. All applications will be performed by the same examiner.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Subjects with 3 or more hypersensitive teeth with a VAS (Visual Analog Scale) score\r\n\r\n          2. Willingness to participate in the study\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Subjects are unwilling to participate voluntarily\r\n\r\n          2. Patients under 18 years old\r\n\r\n          3. Those that were taking analgesic medicaments\r\n\r\n          4. Pregnant and breastfeeding females\r\n\r\n          5. The presence of a systemic disease that affects the participation\r\n\r\n          6. Teeth with cervical loss of hard tissue that need restoration absolutely\r\n\r\n          7. Large/defective restoration, caries or enamel cracks in sensitive teeth\r\n\r\n          8. Teeth with vulnerability to hypersensitivity after root scaling\r\n\r\n          9. Pulpitis presence.\r\n      ","sponsor":"Baskent University","sponsor_type":"Other","conditions":"Dentin Hypersensitivity","interventions":[{"intervention_type":"Other","name":"Other: Teethmate Desensitizer (TM)","description":"Desensitizing agent will be applied to sensitive teeth."},{"intervention_type":"Other","name":"Other: Clearfil SE Bond 2","description":"Desensitizing agent will be applied to sensitive teeth."},{"intervention_type":"Other","name":"Other: Distilled water","description":"Placebo will be applied to sensitive teeth as a negative control."}],"outcomes":[{"outcome_type":"primary","measure":"The effectiveness of desensitizers through long-term period","time_frame":"6 months","description":"The clinical efficacy of a desensitizer that contains calcium phosphate with a two-step self-etch adhesive and placebo through a long-term period. Evaluation will be performed usig the Visual Analog Scale(VAS). VAS values will be according to the following parameters: 0 - no discomfort;1 to 3 - light discomfort;4 to 6 - mild discomfort;7 to 9 - severe discomfort;10 - Unbearable discomfort. After each stimulus to the suspected site the degree of hypersensitivity will be determined from 6 to 10 as the preop VAS score for each individual painful tooth."},{"outcome_type":"secondary","measure":"Subjective satisfaction of patients","time_frame":"6 months","description":"Because of the patient-centered aspect of the study patients' subjective satisfaction will be prior. Patients will be asked to define their sensitivity according to Visual Analog Scale (VAS) scale. VAS values will be according to the following parameters:\r\n0 - no discomfort;1 to 3 - light discomfort;4 to 6 - mild discomfort;7 to 9 - severe discomfort;10 - Unbearable discomfort. In case of persistant or recurrent sensitivity reported by the participants after application of desensitizing agents or placebo, even if the Visual Analog Scale score was decreased, it was accepted as failure, so alternative hypersensitivity treatments applied and current teeth will be excluded."}]}
{"nct_id":"NCT03823599","start_date":"2019-02-01","phase":"N/A","enrollment":20,"brief_title":"Alcohol Brief Intervention Plus Personalized Mobile Chat-based Intervention to Reduce Alcohol Misuse in an Emergency Department","official_title":"A Pilot Study on the Feasibility of Alcohol Brief Intervention Plus Personalized Mobile Chat-based Intervention to Reduce Alcohol Misuse in an Emergency Department in Hong Kong","primary_completion_date":"2019-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-05-30","last_update":"2019-09-26","description":"This project focuses on patients in AED. Objectives of this project are: 1. To examine the factors associated with alcohol drinking and alcohol use disorder 2. To examine the effect of face-to-face alcohol brief intervention on drinking reduction 3. To examine the effect of a continuous interactive chat-based intervention via \"WhatsApp\" on drinking reduction 4. To explore the perception of face-to-face alcohol brief intervention 5. To explore the perception of continuous interactive chat-based intervention via instant messaging mobile application \"WhatsApp\"","other_id":"Pilot alcohol study (AED)","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Hong Kong resident aged 18 to 65\r\n\r\n          2. scored  8 in the Alcohol Use Disorder Identification Test (AUDIT) in the past 12\r\n             months\r\n\r\n          3. able to communicate in Cantonese (including reading Chinese)\r\n\r\n          4. using a phone with instant messaging mobile application \"WhatsApp\" installed for\r\n             communication.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. patients with communication barrier (either physically or cognitively)\r\n\r\n          2. currently participating in other alcohol treatment services or clinics\r\n\r\n          3. will be hospitalized immediate after A&E consultation\r\n      ","sponsor":"The University of Hong Kong","sponsor_type":"Other","conditions":"Alcohol Use Disorder","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Mobile chat-based instant messages","description":"Subjects in the active arm study will receive 5-minute face-to-face ABI, alcohol leaflet from Department of Health (DH) plus continuous interactive chat-based intervention for 1 month as an extension of alcohol brief intervention at baseline"},{"intervention_type":"Behavioral","name":"Behavioral: Alcohol brief intervention","description":"The Control group will receive face-to-face ABI plus an alcohol leaflet from DH."}],"outcomes":[{"outcome_type":"primary","measure":"change in unit of alcohol consumption in gram","time_frame":"at 3-month after baseline.","description":"Assessed by unit in gram and compare the alcohol consumption between intervention and control group at 3-month after baseline."},{"outcome_type":"secondary","measure":"change in unit of alcohol consumption in gram","time_frame":"at 1-month after phase I","description":"Assessed by unit in gram and compare the alcohol consumption between intervention and control group at 1-month after phase I"},{"outcome_type":"secondary","measure":"change in episode of binge drinking measured by asking \"Never\", \"less than a month\", \"two to four times a month\", \" two to three times a week\" and \"almost everyday\"","time_frame":"at 1 and 3 months after phase I","description":"Defined by 5 [male] or 4 [female] in a row for binge drinking and compare the episode of binge drinking between intervention group and control at baseline, 1 and 3-month follow-up questionnaires"},{"outcome_type":"secondary","measure":"change in frequency of drinking by asking \"Never\", \"less than a month\", \"two to four times a month\", \" two to three times a week\" and \"almost everyday\"","time_frame":"at 1 and 3 months after phase I","description":"Compare the frequency of drinking between intervention group and control at baseline, 1 and 3-month follow-up questionnaires"},{"outcome_type":"secondary","measure":"attempt to reduce drinking measured by asking whether they have tried to reduce drinking at past month (yes or no)","time_frame":"at 1 and 3 months after phase I","description":"Compare the attempt to reduce drinking between intervention group and control group at baseline, 1 and 3-month follow-up questionnaires"},{"outcome_type":"secondary","measure":"change in confidence to reduce drinking measured by Likert scale (1-10)","time_frame":"at 1 and 3 months after phase I","description":"Score ranges from 0 to 10 with higher score indicates a high level. The score will be compared between intervention group and control group at baseline, 1 and 3-month follow-up questionnaires"},{"outcome_type":"secondary","measure":"Alcohol Problems Scale at 1 and 3-month follow-up","time_frame":"at 1 and 3 months after phase I","description":"The 14-item measure of alcohol-related personal, social, sexual, and legal problems (eg, being physically aggressive toward someone while under the influence of alcohol).The score will be compared between intervention group and control group at baseline, 1 and 3-month follow-up questionnaires"}]}
{"nct_id":"NCT03828942","start_date":"2019-02-01","enrollment":1000,"brief_title":"Monitoring the HeMAtological TOXicity of Drugs (HeMATOX)","official_title":"Monitoring the HeMAtological TOXicity of Drugs","primary_completion_date":"2022-02-01","study_type":"Observational [Patient Registry]","rec_status":"Recruiting","completion_date":"2022-02-01","last_update":"2020-02-21","description":"Several drugs and chemotherapies seem to have an impact on the hematological system. This study investigates reports of hematological toxicities, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).","other_id":"CIC1421-19-01","observational_model":"Case-Only","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients treated with a drug that could be reported in the WHO's pharmacovigilance database","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Case reported in the WHO's pharmacovigilance database till 01/02/2019\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Chronology not compatible between the drug and the toxicity\r\n      ","sponsor":"Groupe Hospitalier Pitie-Salpetriere","sponsor_type":"Other","conditions":"Hematological Abnormality|Hematotoxicity","interventions":[{"intervention_type":"Drug","name":"Drug: drug inducing hematological toxicity","description":"Drugs susceptible to induce hematological toxicities"}],"outcomes":[{"outcome_type":"primary","measure":"Hematological toxicities of drugs Identification and report of cases of hematological toxicities associated with drugs.","time_frame":"to 01/02/2019","description":"Case reported in the World Health Organization (WHO) database of individual safety case reports"},{"outcome_type":"secondary","measure":"Causality assessment of reported hematological toxicities events according to the WHO system","time_frame":"to 01/02/2019","description":"Case reported in the World Health Organization (WHO) database of individual safety case reports"},{"outcome_type":"secondary","measure":"Description of the type of hematological toxicity depending on the category of drug","time_frame":"to 01/02/2019","description":"Case reported in the World Health Organization (WHO) database of individual safety case reports"},{"outcome_type":"secondary","measure":"Description of the other immune related adverse events concomitant to the hematological toxicity induced by drugs","time_frame":"to 01/02/2019","description":"Case reported in the World Health Organization (WHO) database of individual safety case reports"},{"outcome_type":"secondary","measure":"Description of the duration of treatment when the toxicity happens (role of cumulative dose)","time_frame":"to 01/02/2019","description":"Case reported in the World Health Organization (WHO) database of individual safety case reports"},{"outcome_type":"secondary","measure":"Description of the drug-drug interactions associated with adverse events","time_frame":"to 01/02/2019","description":"Case reported in the World Health Organization (WHO) database of individual safety case reports"},{"outcome_type":"secondary","measure":"Description of the pathologies (cancer) for which the incriminated drugs have been prescribed","time_frame":"to 01/02/2019","description":"Case reported in the World Health Organization (WHO) database of individual safety case reports"},{"outcome_type":"secondary","measure":"Description of the population of patients having hematological toxicity adverse event","time_frame":"to 01/02/2019","description":"Case reported in the World Health Organization (WHO) database of individual safety case reports"}]}
{"nct_id":"NCT03819946","start_date":"2019-02-01","phase":"N/A","enrollment":120,"brief_title":"Improving Oesophageal Protection During AF Ablation","official_title":"Oesophageal Protection: a Novel Approach to Improving the Safety of Catheter Ablation for Atrial Fibrillation.","primary_completion_date":"2020-02-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2020-02-01","last_update":"2020-01-02","description":"Catheter ablation is an established treatment for atrial fibrillation (AF). For those with the more longstanding form of the condition and are graded as longstanding persistent AF, catheter ablation techniques often involve an extensive ablative protocol. This often includes application of ablation energy to the posterior left atrial wall. The left atrial (LA) wall is only on average 5 millimetres away from the esophageal wall. It has been shown that ablation to the posterior LA wall can cause thermal injury to the esophageal wall. Even those that require pulmonary vein isolation only can be at risk of esophageal injury. This injury can impact on patient symptoms as well as increase the risk of an atrio-esophageal fistula being formed. Esophageal protection methods during catheter ablation for AF in current practice is very limited and investigation towards improved approaches, in the form of a randomized clinical trial is required. The aim or purpose of this research project is to study the effect of esophageal cooling on the incidence of esophageal thermal injury (endoscopy-graded esophageal epithelial lesions and/or the presence of ablation-related gastroparesis with patient symptoms) compared to controls, after a catheter ablation procedure for the treatment of AF.","other_id":"IRAS253844","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","intervention_model_description":"This is a randomized clinical trial with 1:1 randomization to the study protocol or the control. The study group will have esophageal protection utilising the esophageal cooling device. The control group will have standard esophageal protection, using an esophageal temperature probe.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n         Any AF patient planned for a catheter ablation procedure or a left atrial ablation\r\n        protocol that puts them at risk of surrounding structural trauma, including oesophageal\r\n        injury.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients at the age extremities will not be approached for the study. (Paediatric\r\n             patients or young adults (<aged 18) or older adults over the age of 85)\r\n\r\n          -  Patients having simple or non-left atrial ablation procedures not needing oesophageal\r\n             protection.\r\n\r\n          -  Patients at high risk of oesophageal bleeding e.g. oesophageal varices.\r\n      ","sponsor":"St. George's Hospital, London","sponsor_type":"Other","conditions":"Esophageal Diseases","interventions":[{"intervention_type":"Device","name":"Device: esophageal cooling device (Attune Medical, Chicago, IL)","description":"The esophageal cooling device is a silicone soft tubing that is designed to be inserted into the esophagus. It is currently used clinically to provide whole body cooling or temperature control for intensive care patients (in medically induced coma or general anesthesia). The tubing is established but not been used in the clinical setting of catheter ablation for AF (which is performed under general anesthesia). During application of ablation energy to the posterior left atrial wall, the tubing is cooled to medium-low levels (25 degrees) and this is controlled by the operator."},{"intervention_type":"Other","name":"Other: Standard esophageal temperature probe","description":"If the participant is randomized to the control group, then a standard esophageal protection method will be used during their catheter ablation procedure. This comprises of an esophageal temperature probe, inserted whilst the patient is under general anesthesia. If during application of ablation treatment to the posterior left atrial wall causes the esophageal temperature to rise above 38 degrees the ablation treatment is halted in this region. If ablation treatment is incomplete, re-application can be applied again cautiously if temperatures fall back to 37 degrees. Further temperature rise of over 38 degrees at the same region is a contra-indication to further ablation work here."}],"outcomes":[{"outcome_type":"primary","measure":"• The incidence of catheter ablation related esophageal injury.","time_frame":"7 days","description":"The incidence of catheter ablation related esophageal injury will be assessed by endoscopic examination. Evidence of thermal injury or symptomatic gastroparesis will be recorded. The thermal injury scale is graded 0-6. 6 being the worst score indicating severe esophageal injury. Endoscopic evidence of gastroparesis is dictated by presence of significant food residue despite >6 hours of fasting and must be correlated with new patient symptoms post-ablation."},{"outcome_type":"secondary","measure":"The incidence of esophageal symptoms after catheter ablation treatment.","time_frame":"3 months","description":"During clinic assessment follow up, the participant will fill out a reflux symptoms questionnaire. This is called the GerdQ questionnaire (GerdQ stands for: gastro-esophageal reflux disease questionnaire). This is a scoring system of range 0-18, a score of 18 being the worst symptoms outcome."},{"outcome_type":"secondary","measure":"• The incidence of major adverse outcomes (MACCE- major adverse cardiovascular cerebrovascular events) will be assessed.","time_frame":"12 months","description":"The major adverse events recorded includes the risk of cerebrovascular accident, transient ischaemic attacks (TIA) and myocardial infarction (MI). For each condition in this MACCE category- the recorded response will either be 'yes' or 'no' or 'positive' or 'negative'."},{"outcome_type":"secondary","measure":"Long-term success rate of the catheter ablation procedure as measured from freedom from the treated arrhythmia (atrial fibrillation/atrial tachycardias).","time_frame":"12 months","description":"During clinic follow up, Holter monitors (ambulatory ECG monitors) or implantable loop recorders will monitor for any recurrence of the treated arrhythmia. Any recurrence will be recorded to assess longterm success of the catheter ablation treatment (this is objectively measured at 12 months). The outcome response is recorded as either 'yes' or 'no'."}]}
{"nct_id":"NCT03722537","start_date":"2019-01-31","phase":"N/A","enrollment":200,"brief_title":"Osteochondral Allograft in the Surgical Treatment of Basal Joint Arthritis","official_title":"Osteochondral Allograft in the Surgical Treatment of Basal Joint Arthritis","primary_completion_date":"2024-01-31","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2024-01-31","last_update":"2018-10-29","description":"This is a study comparing the current standard of care surgical treatment to a newer surgical procedure involving the implantation of osteochondral allograft at the base of the thumb. Patients will be followed at 1, 3, 6 months and 1 year post-operatively.","other_id":"AAAR9273","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18 years of age or older\r\n\r\n          -  Indicated for operative management of basal joint arthritis\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnant women/fetuses/neonates, prisoners\r\n\r\n          -  Previously operated on for treatment of basal joint arthritis\r\n      ","sponsor":"Columbia University","sponsor_type":"Other","conditions":"Basal Joint Arthritis","interventions":[{"intervention_type":"Procedure","name":"Procedure: Osteochondral Allograft","description":"The arthritic bone that the thumb rests on (the trapezium) is removed and replaced with femoral trochlear osteochondral allograft that is designed to be similar in morphology to the human trapezium articular surface."},{"intervention_type":"Procedure","name":"Procedure: Ligament Reconstruction Tendon Interposition","description":"During the LRTI, the arthritic bone that the thumb rests on (the trapezium) is removed. A small cut is made in the forearm to release a tendon, which is moved to the base of the thumb to fill in the area from which the trapezium bone was removed. A small suture anchor is then placed into a thumb bone which holds everything together."}],"outcomes":[{"outcome_type":"primary","measure":"Score on the Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire","time_frame":"Up to 1 year post-operatively","description":"The DASH (Disabilities of the Arm, Shoulder, and Hand) is a 30-item questionnaire that includes 21 physical function items, 6 symptom items, and 3 social/role function items used to evaluate a patient's ability to perform upper extremity activities. Higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability. The score on both test ranges from 0 (no disability) to 100 (most severe disability)."},{"outcome_type":"secondary","measure":"Score on the Thumb Disability Exam (TDX)","time_frame":"Up to 1 year post-operatively","description":"The TDX is a questionnaire that measures changes in thumb function and pain, specifically for those with basal joint arthritis.The TDX is scored on a scale of 0 to 100, with a higher score indicating a greater degree of disability in the thumb."},{"outcome_type":"secondary","measure":"Visual Analog Scale for pain (VAS)","time_frame":"Up to 1 year post-operatively","description":"The VAS is a validated technique that measures acute and chronic pain. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the \"no pain\" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity."}]}
{"nct_id":"NCT03755024","start_date":"2019-01-31","enrollment":102,"brief_title":"WHO Fetal Growth Charts","official_title":"Implementation of WHO Fetal Growth Charts in Assiut,Egypt","primary_completion_date":"2020-01-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2020-05-31","last_update":"2018-11-27","description":"Perinatal mortality and morbidity continue to be major global health challenges strongly associated with prematurity and reduced fetal growth, an issue of further interest given the mounting evidence that fetal growth in general is linked to degrees of risk of common noncommunicable diseases in adulthood. Ultrasound estimation of fetal weight before birth is today very widely used in clinical practice, and, while essential for the identification and management of high-risk pregnancies,the current reference ranges used worldwide are largely based on single populations from a few high-income countries and are therefore of uncertain general applicability.","other_id":"WHOFC","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"Female","minimum_age":18,"maximum_age":40,"population":"pregnant women attending Antenatal care clinic of Women's Health Hospital, Faculty of\r\n        Medicine, Assiut university.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  They have body-mass index between 18-30;\r\n\r\n          -  They have a singleton pregnancy;\r\n\r\n          -  Their gestational age at entry is between 8+0 to 12+6 weeks based on last menstrual\r\n             period.\r\n\r\n          -  They have no history of health, environmental or economic constraints likely to impede\r\n             fetal growth; need for long-term medication (including fertility treatment); smoking\r\n             currently or in the previous 6 months; recurrent miscarriage; and any previous baby\r\n             delivered pre-term (<37 weeks) or with a birth weight <2,500g b. Exclusion criteria:\r\n\r\n          -  Multiple pregnancy\r\n\r\n          -  Congenital fetal malformation (cardiac, cerebral, renal malformations, etc.)\r\n      ","sponsor":"Assiut University","sponsor_type":"Other","conditions":"Fetal Growth Complications","interventions":[{"intervention_type":"Device","name":"Device: ultrasound","description":"The compulsory ultrasound measurements to be obtained at all visits include the following biometrical parameters:\r\nBiparietal diameter\r\nHead circumference\r\nAbdominal circumference\r\nFemur length\r\nHumerus length"}],"outcomes":[{"outcome_type":"primary","measure":"Proportion of fetuses with abnormal fetal growth diagnosed using WHO fetal charts","time_frame":"8 months","description":"correlation of fetal growth pattern with neonatal birth weight and outcome"}]}
{"nct_id":"NCT03640520","start_date":"2019-01-31","phase":"N/A","enrollment":800,"brief_title":"Evaluation of Online Training Tools in Pediatric Resuscitation","official_title":"Randomized Controlled Trial (RCT) to Evaluate the Impact of Online Training Tools Related to Pediatric Resuscitation in General EDs","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2022-03-31","last_update":"2021-03-08","description":"The primary objective is to conduct a randomized controlled trial (RCT) to assess the impact of an online skills training module on 1) individual providers' self-rated confidence and comfort with and current practice of family centered care (FCC) skills; and 2) assess team performance of FCC and resuscitative care skills during simulated pediatric resuscitation scenarios.","other_id":"17-014752","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"Double","intervention_model_description":"Investigators will conduct an RCT of the FACETS online skills training module (intervention) vs. an online training module reviewing pediatric readiness standards for all EDs (control).","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Males or females age 18 years and up.\r\n\r\n          -  Healthcare providers at one of the six to eight general ED sites taking part in\r\n             resuscitations as part of their usual work-related duties\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Not applicable - there are no specific exclusion criteria as all providers who take\r\n             part in resuscitations as part of their usual work-related duties are presumed to be\r\n             capable to take part in simulation and able to read in English at the level required\r\n             to complete online training.\r\n      ","sponsor":"Children's Hospital of Philadelphia","sponsor_type":"Other","conditions":"Family-centered Care in Pediatric Resuscitation","interventions":[{"intervention_type":"Device","name":"Device: FACETS: Pediatric Resuscitation","description":"Family-centered & Trauma-informed Support in Pediatric Resuscitation (FACETS: Pediatric Resuscitation) is an online skills training module for health care professionals involved in pediatric resuscitation in general EDs. The module combines didactic information and scenario-based learning with opportunities for the learner to practice applying their knowledge of FCC practices at key choice points in realistic pediatric resuscitation case scenarios. Training content is guided by evidence regarding FCC practices that are effective in reducing concurrent and ongoing emotional distress in children and family members, and in promoting child and family involvement and satisfaction with care."},{"intervention_type":"Device","name":"Device: Control","description":"An online training module in which participants will receive information and policy education about national pediatric readiness standards for all EDs (including a brief mention of family-centered care as one of these standards), with no specific skills training in FCC. The module provides practice-relevant knowledge related to pediatric differences and pediatric readiness"}],"outcomes":[{"outcome_type":"primary","measure":"Pre- to post-training changes in individual providers' self-rated confidence in providing FCC in pediatric resuscitation","time_frame":"Pre-training survey up to 4 weeks prior to training, Post-training survey up to 6 weeks after training","description":"Pre-training to post-training change in scores on the adapted Family Presence Self-Confidence Scale (FPSCS). The FPSCS is a 29-item scale assessing health care providers' confidence in assisting patients and family members during a resuscitation, and in continuing to provide consistent high quality care while family members are present. It is on 1 to 5 scale, with 1 = not at all confident, 3 = somewhat confident, and 5 = very confident. The FPSCS total score has a potential range of 29 to 145, with higher score indicating greater confidence."},{"outcome_type":"primary","measure":"Pre- to post-training changes in self-reported use of FCC skills in practice","time_frame":"Pre-training survey up to 4 weeks prior to training, Post-training survey up to 6 weeks after training","description":"Pre-training survey up to 4 weeks prior to training, Post-training survey up to 6 weeks after training. The Use of FCC Practices survey is a 29 item questionnaire assessing for past practice of FCC skills (pre-survey) and intention to use those skills in the future (post-survey), via items adapted from the FPSCS measure described above. Responses are on a 1 to 7 scale, with 1 = never did this and 7 = did this every time. The Use of FCC Practices total score has a potential range of 29 to 203, with higher scores indicating greater use of, or intention to use, family-centered care skills in practice."},{"outcome_type":"secondary","measure":"Pre- to post-training changes in team performance of FCC","time_frame":"In situ simulations conducted immediately before and after training.","description":"Based on video review, expert raters (blinded) will use the FCC Assessment Tool to independently rate the quality of team performance of family-centered care during each simulation."},{"outcome_type":"other","measure":"Pre- to post-training changes in resuscitative care","time_frame":"In situ simulations conducted immediately before and after training.","description":"Based on video review, expert raters (blinded) will use the Clinical Performance Tool to independently rate the quality of resuscitation care during each simulation."},{"outcome_type":"other","measure":"Pre- to post-training changes in resuscitative care and in teamwork / team performance","time_frame":"In situ simulations conducted immediately before and after training.","description":"Based on video review, expert raters (blinded) will use the Behavior Assessment Tool to independently rate the quality of teamwork / performance during each simulation."}]}
{"nct_id":"NCT03829709","start_date":"2019-01-30","phase":"N/A","enrollment":20,"brief_title":"Electromiography Study in the Respiratory Muscle Training in Human Lymphotropic Virus Type 1","official_title":"Electromiography Study in the Respiratory Muscle Training in Human Lymphotropic Virus Type 1","primary_completion_date":"2020-07-23","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-07-23","last_update":"2020-08-13","description":"The main objective of the research will be to analyze, through surface electromyography, the impact of inspiratory muscle training before a supervised home training protocol in patients with human T-cell lymphotropic virus type 1 (HTLV-1). For this, a clinical, longitudinal, prospective, quantitative and single center trial will be carried out, aiming at home inspiratory muscle training lasting 5 weeks, 3 times a week, 30 minutes daily through the IMT Threshold, with 14 volunteers enrolled in the Laboratory of Studies in Functional Rehabilitation (LAERF) of the Federal University of Par (UFPA). They will be classified as the manifestation of Tropical Spastic Paraparesis / Myelopathy (PET / MAH) for GP (PET / MAH probable) and GD (PET / MAH definitive) groups, obeying inclusion criteria. For characterization of expiratory flow rates and flows, as well as respiratory muscle strength, they will be submitted to spirometry and manovacuometry, pre, per, and post treatment, respectively. For the analysis of the electromyographic activity, the diaphragm, parasternal and sternocleidomastoid muscles will be counted in the follow-up during the analysis of inspiratory muscle strength, as well as once a week during the conduction of the inspiratory muscle training protocol. The collected data will be stored in a Microsoft Office Excel 2010 worksheet and then submitted to statistical analysis using the Bioestat 5.0 program, adopting a standard error of 5%. The theoretical support of the research will have a bibliographical survey of scientific articles collected during the design of the project, and the accomplishment of the research. It is expected to map, through the surface electromyographic study, the impact of respiratory muscle training at a distance on the inspiratory muscle strength of patients with HTLV-I virus with probable or definitive PET / MAH.","other_id":"2,629,073","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Rehabilitation","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  volunteers of both sexes\r\n\r\n          -  HTLV-1 positive serology with definitive or probable PET / MAH\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  pulmonary diseases\r\n\r\n          -  serious comorbidities such as heart disease and uncontrolled arterial hypertension\r\n\r\n          -  cognitive alterations that impede the conduction of the protocol\r\n      ","sponsor":"Universidade Metodista de Piracicaba","sponsor_type":"Other","conditions":"HTLV-I Infections","interventions":[{"intervention_type":"Other","name":"Other: Rehabilitation","description":"The first training session each week will be held at the LAERF under the direct supervision of the investigator and the other two home-based training sessions under the supervisor's distance supervision. They will receive the Threshold IMT linear loading device, and guidelines for handling, posture and asepsis. The initial training load for each participant will be adjusted to 25% of PiMx. Participants will be trained and instructed to do the exercise program on their own at home. Once a week, during the return to the laboratory the researcher will determine the new values for load (1st week 25%, 2nd week 35%, 3rd week 40%, 4th week 45%, 5th week 50%)."}],"outcomes":[{"outcome_type":"primary","measure":"Inspiratory and expiratory muscle force","time_frame":"Five weeks","description":"The evaluation of respiratory muscle strength will be performed by measuring the maximal inspiratory pressure (PiMáx) and expiratory (PeMAx) measurements with manovacuometer (+ - 300cmH2O). In order to perform the measurement of PiMáx and PeMáx, referring to inspiratory and expiratory muscle strength respectively. The values can range from 0 to 300 cmH2O, being 0 no strength and 300 maximum respiratory muscle strength."}]}
{"nct_id":"NCT03774784","start_date":"2019-01-29","enrollment":26,"brief_title":"A Study of the Natural History of Leukocyte Chemotactic Factor 2 Amyloidosis (ALECT2) Disease","official_title":"A Study of the Natural History of Leukocyte Chemotactic Factor 2 Amyloidosis (ALECT2) Disease","primary_completion_date":"2020-05-18","study_type":"Observational","rec_status":"Terminated","completion_date":"2020-05-18","last_update":"2020-06-16","description":"The purpose of this study is to characterize the natural history of leukocyte chemotactic factor 2 amyloidotic (ALECT2) disease. In this observational study participants with ALECT2 disease will be enrolled. Participants, who have already reached end-stage renal disease (ESRD), will provide retrospective chart review data and biological specimens at baseline only. Other participants, in addition to retrospective chart review, will be followed prospectively.","other_id":"ALN-LECT2-NT-001","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"Participants with biopsy-proven ALECT2.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Males and females, age 18 years or older;\r\n\r\n          -  Renal biopsy-proven diagnosis of ALECT2;\r\n\r\n          -  For patients with kidney disease that could be due to ALECT2, a renal biopsy may be\r\n             obtained to confirm ALECT2 diagnosis.\r\n\r\n        Exclusion Criteria:\r\n\r\n        - There are no exclusion criteria for this observational study.\r\n      ","sponsor":"Alnylam Pharmaceuticals","sponsor_type":"Industry","conditions":"Amyloidosis|Leukocyte Chemotactic Factor 2 Amyloidosis","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Time to End-Stage Renal Disease (ESRD)","time_frame":"From baseline to end of study (Month 48)"},{"outcome_type":"primary","measure":"Change in Estimated Glomerular Filtration Rate (eGFR) from Baseline Up to End of Study (Month 48)","time_frame":"Baseline (Day 1), Months 6, 12, 18, 24, 30, 36, 42 and 48"},{"outcome_type":"secondary","measure":"Level of Leukocyte Chemotactic Factor 2 (LECT2) Messenger Ribonucleic Acid (mRNA) in Blood","time_frame":"Baseline (Day 1), Months 6, 12, 18, 24, 30, 36, 42 and 48"},{"outcome_type":"secondary","measure":"Level of LECT2 mRNA in Urine","time_frame":"Baseline (Day 1), Months 12, 24, 36 and 48"},{"outcome_type":"secondary","measure":"Level of LECT2 Protein in Blood","time_frame":"Baseline (Day 1), Months 6, 12, 18, 24, 30, 36, 42 and 48"},{"outcome_type":"secondary","measure":"Level of LECT2 Protein in Urine","time_frame":"Baseline (Day 1), Months 12, 24, 36 and 48"},{"outcome_type":"secondary","measure":"Percentage of Participants With Proteinuria","time_frame":"Baseline (Day 1), Months 12, 24, 36 and 48"}]}
{"nct_id":"NCT03804489","start_date":"2019-01-25","phase":"N/A","enrollment":180,"brief_title":"Using \"Decision Aids\" to Help the Infant Family to Decide the Use of Oral Rotavirus Vaccine","official_title":"Using \"Decision Aids\" to Help the Infant Family to Decide Whether the Baby Will Receive the Self-paid Oral Rotavirus Vaccine: A Randomized Controlled Trial.","primary_completion_date":"2019-10-25","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-12-25","last_update":"2019-01-15","description":"Using decision aids (DA) is one way to provide information to infant family and to involve them in making decisions about their baby's vaccination. We developed a DA administered after consultation for baby's family deciding on whether the baby will receive the self-paid oral rotavirus vaccine","other_id":"108HHC-03","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"Double","intervention_model_description":"Decision aids","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        The one-month-old baby's family whose age is between 20 and 80 years old.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. . The doctor determines that the baby's family is not suitable; if baby's family\r\n             cannot understand Chinese languages what we said.\r\n\r\n          2. . The participants' baby who have fever or contraindication for oral rotavirus.\r\n      ","sponsor":"Taipei Medical University Shuang Ho Hospital","sponsor_type":"Other","conditions":"Rotavirus Vaccines","interventions":[{"intervention_type":"Other","name":"Other: Decision aids","description":"Decision aids in helping the infant family to decide whether the infant will or will not receive the oral rotavirus vaccine."}],"outcomes":[{"outcome_type":"primary","measure":"Decisional conflict","time_frame":"An average of 1 month after intervention","description":"Total score of decisional conflict scale"},{"outcome_type":"primary","measure":"Decision-making difficulties","time_frame":"An average of 1 month after intervention","description":"Total score of decision-making scale"}]}
{"nct_id":"NCT03849482","start_date":"2019-01-24","enrollment":100,"brief_title":"Multiparametric Magnetic Resonance Imaging Versus Fine Needle Aspiration Cytology for Parotid Gland Neoplasms","official_title":"Accuracy of Multiparametric Magnetic Resonance Imaging Versus Fine Needle Aspiration Cytology in the Preoperative Work-Up of Parotid Gland Neoplasms","primary_completion_date":"2021-12-31","study_type":"Observational [Patient Registry]","rec_status":"Recruiting","completion_date":"2021-12-31","last_update":"2019-02-22","description":"Parotid gland tumors are mostly treated surgically, but the extent of parotidectomy is decided upon preoperative work-up information. Preoperative management generally includes clinical evaluation, collection of a pathological sample, most often through fine-needle aspiration cytology (FNAC), and imaging. FNAC, despite its high sensitivity and specificity, has the drawback of an approximately 20 per cent rate of nondiagnostic or indeterminate result. Magnetic Resonance Imaging (MRI) provides the best morphological description of the lesion, which is helpful to the surgeon for the planning of the intervention. Recently, advanced functional techniques have been introduced, in association to the conventional morphologic ones: diffusion-weighted imaging (DWI) and dynamic contrast-enhanced imaging (DCEI) demonstrated the ability to provide information about the possible histological origin of parotid lesions. Multiparametric MRI (mp-MRI) comes from the combination of anatomical and functional sequences. The Authors postulate that mp-MRI evaluation may be able to provide information not only about the extension of the lesion, but also about histology, with a high accuracy, at least comparable to ultrasound-guided FNAC. In the present study, the Authors aim to define the value of FNAC and mp-MRI in the preoperative management of parotid gland tumors, comparing their success intended as the capability of the exam to be both diagnostic and accurate in formulating the correct histological suspect of malignancy. Participants are patients affected by parotid gland neoplasms, candidates for surgical resection. The lesion will preoperatively be assessed with both clinical evaluation, ultrasound-guided FNAC and mp-MRI in our Institution. Mp-MRI includes conventional sequences, DWI and DCEI; its interpretation will allow the definition of the suspect histology. FNAC and mp-MRI suspects will be compared to the final histopathological report after surgical removal of the neoplasm. The study considers a total of 100 patients, of whom 50 are analyzed retrospectively (being already operated after obtaining both FNAC and mp-MRI preoperatively) and the remaining 50 to be enrolled prospectively.","other_id":"MultiParotid","observational_model":"Cohort","time_perspective":"Other","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Participants are affected by parotid gland neoplasms candidate for surgical removal. The\r\n        lesion will be preoperatively assessed by both clinical evaluation, ultrasound-guided fine\r\n        needle aspiration citology and multiparametric MRI. Participants will undergo surgery and\r\n        the pathology report will be collected.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Parotid gland tumor, candidate for surgical removal\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Non-neoplastic lesions (inflammatory, infectious)\r\n\r\n          -  Lesions smaller than 1 cm (multiparametric MRI analysis not feasible)\r\n\r\n          -  Patients who refuse surgical procedure\r\n\r\n          -  Patients who refuse to take part to the present study\r\n      ","sponsor":"Davide Di Santo","sponsor_type":"Other","conditions":"Parotid Neoplasm|Parotid Cancer","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Multiparametric Magnetic Resonance Imaging","description":"Multiparametric MRI evaluation includes Conventional MRI, Diffusion-Weighted MRI and Dynamic Contrast-Enhanced MRI"},{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Fine Needle Aspiration Cytology","description":"Ultrasound-Guided Fine Needle Aspiration Cytology"},{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Clinical Evaluation","description":"Patient's history and physical examination, reporting signs and symptoms suggestive of malignancy (pain, facial nerve weakness, fixation to skin and surrounding tissues, trismus, skin ulceration, lymphadenopathy, numbness, weight loss)"},{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Final Histopathological Diagnosis","description":"Final Diagnosis of the Disease from the Pathology Report after Surgical Resection of the Lesion"}],"outcomes":[{"outcome_type":"primary","measure":"Success of the diagnostic test (Multiparametric MRI and Fine Needle Aspiration Cytology) in the preoperative diagnosis of parotid gland tumors","time_frame":"Baseline (preoperative)","description":"Success is intended as the capability of the diagnostic test (Multiparametric MRI and Fine Needle Aspiration Cytology) to be diagnostic (i.e. to make a diagnosis of benignity or malignancy) AND to correctly identify malignant tumors, compared to the final histopathological report"},{"outcome_type":"secondary","measure":"Accuracy of the diagnostic test (clinical evaluation, fine needle aspiration cytology, conventional MRI, multiparametric MRI) in the preoperative diagnosis of parotid gland tumors","time_frame":"Baseline (preoperative)","description":"Diagnostic accuracy of the test (clinical evaluation, fine needle aspiration cytology, conventional MRI, multiparametric MRI) is defined as the number of malignant lesions with \"malignant\" results in addition to benign lesions with \"benign\" results as a percentage of the total number of lesions"},{"outcome_type":"secondary","measure":"Accuracy of the diagnostic test (Multiparametric MRI and Fine Needle Aspiration Cytology) in the preoperative diagnosis of the histopathology of parotid gland tumors","time_frame":"Baseline (preoperative)","description":"Diagnostic accuracy of the test (Multiparametric MRI and Fine Needle Aspiration Cytology) is intended as the capability to preoperatively identify the histopathology of the tumor (pleomorphic adenoma, warthin tumor, carcinoma, lymphoma)"}]}
{"nct_id":"NCT03796442","start_date":"2019-01-23","phase":"N/A","enrollment":140,"brief_title":"Comparison of Two Pericardial Bioprostheses in AVR","official_title":"Early and 1-year Hemodynamic Performance and Clinical Outcomes After Aortic Valve Replacement Using Two Pericardial Bioprostheses: A Multicenter Randomized Controlled Trial","primary_completion_date":"2022-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-12-31","last_update":"2021-02-12","description":"The purpose of the study is to compare early and 1-year hemodynamic performance and clinical outcomes after aortic valve replacement using two pericardial bioprosthesis, Avalus and Carpentier Edwards Perimount Magna Ease.","other_id":"D-1812-024-991","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":19,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  patients who are going to undergo aortic valve replacement with bioprosthesis\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  heart failure with severe LV dysfunction (LV EF <30%)\r\n\r\n          -  active infective endocarditis\r\n\r\n          -  with other critical cardiovascular disease (e.g. acute aortic dissection)\r\n\r\n          -  with other critical comorbities by which the expected life span is less than 1 year\r\n\r\n          -  inadequate participant by the researcher's discretion\r\n      ","sponsor":"Seoul National University Hospital","sponsor_type":"Other","conditions":"Aortic Valve Disease","interventions":[{"intervention_type":"Device","name":"Device: AVR with AVALUS","description":"aortic valve replacement with AVALUS bioprosthesis"},{"intervention_type":"Device","name":"Device: AVR with CEPME","description":"aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis"}],"outcomes":[{"outcome_type":"primary","measure":"transvalvular mean Pressure Gradient (mPG)","time_frame":"at postoperative 1 year","description":"transvalvular mean pressure gradient measured by trans-thoracic echocardiography"},{"outcome_type":"secondary","measure":"effective orifice area (EOA)","time_frame":"at postoperative 1 year","description":"effective orifice area measured by trans-thoracic echocardiography"},{"outcome_type":"secondary","measure":"Op mortality","time_frame":"at postoperative 30 days or at the time of discharge","description":"any death within 30 days after surgery or during the same hospital admission"},{"outcome_type":"secondary","measure":"Op morbidities","time_frame":"at postoperative 1 year","description":"low cardiac output syndrome, bleeding reoperation, perioperative myocardial infarction, stroke, acute kidney injury, respiratory complication, new onset atrial fibrillation, mediastinitis, surgical wound infection"},{"outcome_type":"secondary","measure":"All-cause mortality","time_frame":"at postoperative 1 year","description":"all deaths from any cause"},{"outcome_type":"secondary","measure":"Cardiac death","time_frame":"at postoperative 1 year","description":"Any death related to cardiac events, including sudden death during follow-up"},{"outcome_type":"secondary","measure":"Aortic valve-related events","time_frame":"at postoperative 1 year","description":"valve-related mortality, thromboembolism, bleeding, endocarditis, reoperation"}]}
{"nct_id":"NCT03802409","start_date":"2019-01-20","enrollment":500,"brief_title":"The Real Word Study of Albumin-binding Taxol for Lung Cancer Treatment","official_title":"The Real Word Study of Albumin-binding Taxol for Lung Cancer Treatment","primary_completion_date":"2020-01-01","study_type":"Observational","rec_status":"Unknown status","completion_date":"2020-06-30","last_update":"2019-01-22","description":"The investigators conduct the real world study to explore the efficacy and safety of Albumin-binding taxol in lung cancer .","other_id":"AHAT-105","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Confirmed by Histopathology or Cytology of Lung cancer","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Male or female patients .\r\n\r\n          2. Confirmed by Histopathology or Cytology of Lung Cancer\r\n\r\n          3. Patients should be voluntary to the trial and provide with signed informed consent\r\n\r\n          4. The researchers believe patients can benefit from the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients with a known history of allergic reactions and/or hypersensitivity attributed\r\n             to Albumin-binding taxol or its accessories\r\n\r\n          2. Pregnant or lactating women\r\n\r\n          3. Patients with Albumin-binding taxol contraindications\r\n\r\n          4. Patients of doctors considered unsuitable for the trial\r\n      ","sponsor":"The First Affiliated Hospital of Anhui Medical University","sponsor_type":"Other","conditions":"Lung Cancer","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Progress free survival","time_frame":"1 year","description":"Progress free survival is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress."},{"outcome_type":"secondary","measure":"Overall Survival","time_frame":"3 year","description":"overall survival is defined as the length of time from random assignment to death or to last contact."},{"outcome_type":"secondary","measure":"disease control rate","time_frame":"1 year","description":"Investigators will assess treatment response according to Response Evaluation Criteria in Solid Tumors 1.1"},{"outcome_type":"secondary","measure":"Objective tumor response rate","time_frame":"1 year","description":"Objective tumor response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as best overall response according to radiological assessments"},{"outcome_type":"other","measure":"Quality of life score","time_frame":"1 year","description":"Quality of life score is a questionnaire developed to assess the quality of life of cancer patients."},{"outcome_type":"other","measure":"adverse events","time_frame":"1 year","description":"adverse events are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0."}]}
{"nct_id":"NCT04160247","start_date":"2019-01-17","phase":"Phase 3","enrollment":40,"brief_title":"Angulated Screw-retained Crowns Following Immediate Implant Placement","official_title":"Clinical Evaluation of Cemented and Angulated Screw-retained Crowns Following Immediate Implant Placement: a Randomized Controlled Clinical Trials","primary_completion_date":"2019-03-20","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-03-20","last_update":"2021-01-25","description":"There are two choices of restorations and implant abutments connection now: cemented and screw-retained.The excess cement, which would be difficult to completely remove, might lead to series of biological complications. The angulated screw channel (ASC) abutments, which recently introduced by Nobel Biocare , largely address the problem with visible screw access that may compromise esthetics. However, all of the present studies were clinical reports, thus the clinical efficacy of ASC abutments still needs the verification of evidence-based medicine with larger sample. Therefore, we designed a randomized controlled clinical trial study, aiming to verify the clinical efficacy of the ASC abutments by comparing screw-retained (with ASC abutments) single implant crowns with cemented ones in esthetic region.","other_id":"SH9-19-07","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. 18 years old and in good health;\r\n\r\n          2. Single tooth implant (type 1) in the esthetic region;\r\n\r\n          3. Patients with natural teeth adjacent to single implant crowns;\r\n\r\n          4. Patients with periodontal treatment before implant surgery;\r\n\r\n          5. The implants are from Nobel Biocare system with tapered link and the permanent\r\n             restoration is a single crown and all-ceramic;\r\n\r\n          6. Soft tissue in the implanting-and-adjacent areas is healthy and free of infection\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Multiple implants in the esthetic region, or the restoration is a bridge\r\n\r\n          2. Patients with bone augmentation procedures;\r\n\r\n          3. Heavy smokers (>10 cigarettes/day);\r\n\r\n          4. Medically compromised patients (American Society of Anesthesiologists (ASA)\r\n             classification III-IV);\r\n\r\n          5. Implants in an incorrect three-dimensional position (definition according to ITI\r\n             VOL1);\r\n\r\n          6. Uncontrolled diabetes mellitus;\r\n\r\n          7. Unwilling to participate in the present study.\r\n      ","sponsor":"Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University","sponsor_type":"Other","conditions":"Tooth Diseases","interventions":[{"intervention_type":"Procedure","name":"Procedure: Immediate implant placement","description":"Implants are placed in fresh socket"},{"intervention_type":"Procedure","name":"Procedure: Angulated screw-retained crowns placement","description":"To insert the restorations by angulated screw systems"},{"intervention_type":"Procedure","name":"Procedure: Cemented crowns placement","description":"To cement the restorations onto the implant abutment"}],"outcomes":[{"outcome_type":"primary","measure":"BOP%","time_frame":"from baseline to 1-year follow-up","description":"Percentage of bleeding on probing positive"},{"outcome_type":"secondary","measure":"PPD","time_frame":"from baseline to 1-year follow-up","description":"Pocket probing depth"},{"outcome_type":"secondary","measure":"MBL","time_frame":"from baseline to 1-year follow-up","description":"Marginal bone loss"},{"outcome_type":"secondary","measure":"PES","time_frame":"from baseline to 1-year follow-up","description":"pink esthetic score"}]}
{"nct_id":"NCT03825276","start_date":"2019-01-15","phase":"N/A","enrollment":35,"brief_title":"Effect of Mango on Gut Microbiota and Metabolic Health","official_title":"Metabolic Adaptations and Role of Nutritionally-Mediated Gut Microbiota Changes Following Mango Consumption in Overweight Men and Women : The MANGO Pilot Study","primary_completion_date":"2019-12-20","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2022-12-31","last_update":"2021-07-07","description":"Mango is rich in bioactive compounds such as dietary polyphenols and carotenoids, which may explain its beneficial effect on health. Polyphenols accumulate in the gut where they can positively modulate the microbiota. As gut microbiota may have a strong influence on cardiometabolic health, we hypothesize that mango consumption improves metabolic profile in overweight or obese individuals through beneficial changes in gut microbiota. The study of metagenomics, transcriptomics and metabolomics will be used to validate this hypothesis.","other_id":"MANGO 2018-147","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy men and premenopausal women\r\n\r\n          -  At least one of the following : BMI between 25 and 40 kg/m2 or Waist circumference \r\n             80 cm for women and  94 cm for men\r\n\r\n          -  At least one of the following : TG  1.35 mmol/L or fasting insulinemia  42 pmol/L\r\n\r\n          -  Caucasian origin\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Nicotine use\r\n\r\n          -  Metabolic disorders or use of medication that may affect parameters measured in the\r\n             study\r\n\r\n          -  Use of dietary supplements or natural health product that may affect parameters\r\n             measured in the study\r\n\r\n          -  Use of antibiotics in the last 3 months\r\n\r\n          -  Surgery in the last 3 months or planned during the study timeline\r\n\r\n          -  Alcohol consumption >2 drinks/day\r\n\r\n          -  Weight change >5% in the last 3 months\r\n\r\n          -  Mango aversion, allergy or intolerance\r\n\r\n          -  Dietary restrictions (vegetarian, gluten avoidance...)\r\n\r\n          -  Berries consumption >1 serving/day\r\n\r\n          -  Pregnancy, breastfeeding or pregnancy planned within 3-6 months\r\n      ","sponsor":"Laval University","sponsor_type":"Other","conditions":"Gut Microbiota|Metabolic Syndrome","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Mango consumption","description":"Daily consumption of 280 g of frozen mangos during 8 weeks. The daily dose in equivalent to a 2-cups serving."}],"outcomes":[{"outcome_type":"secondary","measure":"Changes in plasma metabolites concentration in overweight/obese men and women taking frozen mangos daily","time_frame":"8 weeks","description":"Metabolites include acylcarnitines, glycerophospholipids, sphingolipids, sugars, amino acids, biogenic amines"},{"outcome_type":"secondary","measure":"Changes in gene expression in peripheral blood mononuclear cells (PBMC) of overweight/obese men and women taking frozen mangos daily","time_frame":"8 weeks","description":"Gene-level expression from >20,000 annotated genes will be examined"},{"outcome_type":"primary","measure":"Changes in plasma insulin concentration of overweight/obese men and women taking frozen mangos daily","time_frame":"8 weeks"},{"outcome_type":"primary","measure":"Changes in plasma glucose concentration of overweight/obese men and women taking frozen mangos daily","time_frame":"8 weeks"},{"outcome_type":"primary","measure":"Changes in plasma triglycerides concentration of overweight/obese men and women taking frozen mangos daily","time_frame":"8 weeks"},{"outcome_type":"primary","measure":"Changes in plasma total cholesterol concentration of overweight/obese men and women taking frozen mangos daily","time_frame":"8 weeks"},{"outcome_type":"primary","measure":"Changes in plasma HDL cholesterol concentration of overweight/obese men and women taking frozen mangos daily","time_frame":"8 weeks"},{"outcome_type":"primary","measure":"Changes in plasma LDL cholesterol concentration of overweight/obese men and women taking frozen mangos daily","time_frame":"8 weeks"},{"outcome_type":"secondary","measure":"Changes in waist circumference of overweight/obese men and women taking frozen mangos daily","time_frame":"8 weeks"},{"outcome_type":"secondary","measure":"Changes in hip circumference of overweight/obese men and women taking frozen mangos daily","time_frame":"8 weeks"},{"outcome_type":"secondary","measure":"Changes in waist to hip circumference ratio of overweight/obese men and women taking frozen mangos daily","time_frame":"8 weeks","description":"Waist and hip circumference will be combined to report waist to hip ratio"},{"outcome_type":"secondary","measure":"Height of overweight/obese men and women taking frozen mangos daily","time_frame":"Baseline"},{"outcome_type":"secondary","measure":"Changes in weight of overweight/obese men and women taking frozen mangos daily","time_frame":"8 weeks"},{"outcome_type":"secondary","measure":"Changes in body mass index (BMI) of overweight/obese men and women taking frozen mangos daily","time_frame":"8 weeks","description":"Weight and height will be combined to report BMI"},{"outcome_type":"secondary","measure":"Changes in systolic blood pressure of overweight/obese men and women taking frozen mangos daily","time_frame":"8 weeks"},{"outcome_type":"secondary","measure":"Changes in diastolic blood pressure of overweight/obese men and women taking frozen mangos daily","time_frame":"8 weeks"},{"outcome_type":"secondary","measure":"Changes in insulin secretion of overweight/obese men and women taking frozen mangos daily","time_frame":"8 weeks"},{"outcome_type":"secondary","measure":"Changes in insulin sensitivity of overweight/obese men and women taking frozen mangos daily","time_frame":"8 weeks"},{"outcome_type":"secondary","measure":"Changes in glycated hemoglobin (HbA1c) in overweight/obese men and women taking frozen mangos daily","time_frame":"8 weeks"},{"outcome_type":"secondary","measure":"Changes in plasma tumor necrosis factor (TNF-alpha) concentration of overweight/obese men and women taking frozen mangos daily","time_frame":"8 weeks"},{"outcome_type":"secondary","measure":"Changes in plasma interleukin-6 (IL-6) concentration of overweight/obese men and women taking frozen mangos daily","time_frame":"8 weeks"},{"outcome_type":"secondary","measure":"Changes in plasma high-sensitivity C-reactive protein (hs-CRP) concentration of overweight/obese men and women taking frozen mangos daily","time_frame":"8 weeks"},{"outcome_type":"secondary","measure":"Changes in gut microbiota composition in overweight/obese men and women taking frozen mangos daily","time_frame":"8 weeks","description":"Stool samples will be collected and whole metagenome shotgun sequencing analysis will be conducted"},{"outcome_type":"secondary","measure":"Changes in plasma lipopolysaccharide (LPS) concentration of overweight/obese men and women taking frozen mangos daily","time_frame":"8 weeks"},{"outcome_type":"secondary","measure":"Changes in plasma LPS binding protein (LBP) concentration of overweight/obese men and women taking frozen mangos daily","time_frame":"8 weeks"}]}
{"nct_id":"NCT04406805","start_date":"2019-01-15","enrollment":70,"brief_title":"TMAO in Patients With Severe Aortic Stenosis","official_title":"Concentration of Trimethylamine-N-oxide Versus Echocardiographic, Biochemical and Histopathological Parameters of Heart Failure in Patients With Severe Aortic Stenosis: a Prospective, Observatory Trial","primary_completion_date":"2022-02-15","study_type":"Observational","rec_status":"Recruiting","completion_date":"2023-02-15","last_update":"2020-06-05","description":"Trimethylamine N-oxide (TMAO) has recently gained increasing scientific interest in the field of cardiovascular disease, including its role in cell protection against osmotic and hydrostatic stress. Aortic stenosis (AS) is the most common valvular heart disease, affecting about 7.6 million people over 75 years of age in North America and Europe alone. We hypothesized that TMAO plays a role in protection of the cardiomyocytes against pressure overload in patients with AS. The primary aim of this study is to assess the correlation between the serum and urine TMAO concentration, and (i) echocardiographic, (ii) biochemical and (iii) histopathological parameters of heart failure in patients with severe AS. The secondary aim of this study is to evaluate a correlation between the baseline TMAO concentrations and the post-treatment clinical status, as well as the post-treatment echocardiographic and biochemical parameters.","other_id":"KB/211/2018","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":99,"population":"Patients will be enrolled among those who will be (i) aged from 18 to 99 years, (ii)\r\n        admitted to the 1st Chair and Department of Cardiology or Department of Cardiosurgery,\r\n        Medical University of Warsaw due to severe AS, and (iii) qualified for treatment with\r\n        either surgical aortic valve replacement or transcatheter aortic valve implantation.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Informed consent to participate in the study\r\n\r\n          -  Severe aortic stenosis, defined as aortic valve area <1.0 cm2 or aortic valve area\r\n             index <0.6 cm2/m2 as calculated by the continuity equation on transthoracic\r\n             echocardiography, regardless of the transvalvular gradient, with or without coexisting\r\n             symptoms of heart failure\r\n\r\n          -  Qualification for surgical aortic valve replacement or transcatheter aortic valve\r\n             implantation by the Heart Team in accordance with European Society of Cardiology\r\n             guidelines\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Heart failure of etiology other than aortic stenosis\r\n\r\n          -  Coexisting, haemodynamically significant aortic regurgitation\r\n\r\n          -  Myocardial infarction within the last 3 months\r\n\r\n          -  Coronary revascularization within the last month or planned during transcatheter\r\n             aortic valve implantation or surgical aortic valve replacement\r\n\r\n          -  Chronic kidney disease with estimated glomerular filtration rate <45 ml/min/1.73 m2\r\n\r\n          -  Acute gastrointestinal disease within the last month\r\n\r\n          -  Active neoplastic disease\r\n\r\n          -  Chronic inflammatory disease\r\n\r\n          -  Autoimmune disease\r\n\r\n          -  Chronic intestinal disease\r\n\r\n          -  Antibiotic therapy within the last 2 months\r\n\r\n          -  Dietary supplements within the last 7 days\r\n      ","sponsor":"Medical University of Warsaw","sponsor_type":"Other","conditions":"Aortic Stenosis|Heart Failure","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Measurement of plasma and urine trimethylamine-N-oxide concentration","description":"Information already included in arm/group descriptions."}],"outcomes":[{"outcome_type":"primary","measure":"Correlation between the serum and urine trimethylamine N-oxide concentration and aortic valve area index","time_frame":"January 15, 2019 - February 15, 2023"},{"outcome_type":"secondary","measure":"Correlation between the serum and urine trimethylamine N-oxide concentration and (i) other echocardiographic, (ii) biochemical and (iii) histopathological parameters of heart failure.","time_frame":"January 15, 2019 - February 15, 2023"},{"outcome_type":"secondary","measure":"Correlation between the baseline trimethylamine N-oxide concentrations and the post-treatment clinical status, as well as the post-treatment echocardiographic and biochemical parameters.","time_frame":"January 15, 2019 - February 15, 2023"}]}
{"nct_id":"NCT03749460","start_date":"2019-01-15","phase":"Phase 1/Phase 2","enrollment":20,"brief_title":"Nivolumab and Ipilimumab and Stereotactic Body Radiation Therapy in Treating Patients With Salivary Gland Cancers","official_title":"Dual Immune Checkpoint Blockade and Hypofractionated Radiation in Patients With Salivary Gland Cancers","primary_completion_date":"2023-12-22","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2027-12-22","last_update":"2021-07-21","description":"This phase I/II trial studies the side effects and how well nivolumab and ipilimumab works when given together with stereotactic body radiation therapy (SBRT) in treating patients with salivary gland cancers. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving nivolumab and ipilimumab and SBRT may work better in treating patients with advanced salivary gland cancers.","other_id":"RG1718030","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically proven salivary gland carcinoma (World Health Organization [WHO], 2005)\r\n             arising from a previous head and neck primary site, and located within the head and\r\n             neck region, lung or bone, and who are not candidates for curative intent therapy\r\n\r\n          -  Demonstrated disease progression during, or after discontinuation, of the most recent\r\n             line of systemic therapy\r\n\r\n          -  Have received any number lines of prior systemic therapy (including systemic therapy\r\n             in the curative intent setting)\r\n\r\n          -  Have a target lesion/s deemed suitable by the treating physicians for stereotactic\r\n             body radiation therapy (SBRT) with the intent of palliation or prevention of symptoms.\r\n             This lesion must be:\r\n\r\n               -  1-3 non-overlapping sites in the head and neck region OR\r\n\r\n               -  Metastatic lesions outside the head and neck (H&N) region in the lung or bone (a\r\n                  minimum of 1 and a maximum 5 lesions will be irradiated), provided there is no\r\n                  significant overlap between the lesions\r\n\r\n                    -  Patients should have RECIST 1.1 criteria measurable disease in addition to\r\n                       the lesion/s treated with SBRT. If the site/s of SBRT were previously\r\n                       radiated to high dose radiation therapy (RT) (> 50Gy), there should be > 6\r\n                       month time interval between the last dose of radiation and the start of SBRT\r\n\r\n          -  Have the ability to tolerate required SBRT-related procedures (e.g.: lie flat and hold\r\n             position for treatment) as determined by the treating physician\r\n\r\n          -  Be willing and able to provide written informed consent for the trial and comply with\r\n             the study visit requirements\r\n\r\n          -  Have measurable disease based on RECIST 1.1. (in addition to the lesion/s that will be\r\n             treated with stereotactic radiation therapy)\r\n\r\n          -  Have provided tissue from an archival tissue sample or newly obtained core or\r\n             excisional biopsy of a tumor lesion. Tissue requirement will be waived if deemed\r\n             contraindicated or not clinically available/accessible for resection per the treating\r\n             physician (principal investigator [PI] approval required)\r\n\r\n          -  Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)\r\n             performance scale\r\n\r\n          -  Hemoglobin >= 9.0 g/dL (performed within 10 days of treatment initiation)\r\n\r\n          -  Absolute neutrophil count (ANC) >= 1.5 x 10^9 /L (>= 1500 per mm^3) (performed within\r\n             10 days of treatment initiation)\r\n\r\n          -  Platelet count >= 100 x 10^9 /L (>= 100,000 per mm^3) (performed within 10 days of\r\n             treatment initiation)\r\n\r\n          -  Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN). This will not\r\n             apply to subjects with confirmed Gilbert's syndrome (persistent or recurrent\r\n             hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or\r\n             hepatic pathology), who will be allowed only in consultation with their physician\r\n             (performed within 10 days of treatment initiation)\r\n\r\n          -  Aspartate aminotransferases (AST) (serum glutamic-oxaloacetic transaminase\r\n             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])\r\n             =< 2.5 x institutional upper limit of normal unless liver metastases are present, in\r\n             which case it must be =< 5 x ULN (performed within 10 days of treatment initiation)\r\n\r\n          -  Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula (Cockcroft\r\n             and Gault 1976) or by 24-hour urine collection for determination of creatinine\r\n             clearance (performed within 10 days of treatment initiation)\r\n\r\n          -  Evidence of post-menopausal status OR negative urinary or serum pregnancy test for\r\n             female pre-menopausal patients. Women will be considered post-menopausal if they have\r\n             been amenorrheic for 12 months without an alternative medical cause. The following\r\n             age-specific requirements apply:\r\n\r\n               -  Women < 50 years of age would be considered post-menopausal if they have been\r\n                  amenorrheic for 12 months or more following cessation of exogenous hormonal\r\n                  treatments and if they have luteinizing hormone and follicle stimulating hormone\r\n                  levels in the post-menopausal range for the institution or underwent surgical\r\n                  sterilization (bilateral oophorectomy, or hysterectomy)\r\n\r\n               -  Women >= 50 years of age would be considered post-menopausal if they have been\r\n                  amenorrheic for 12 months or more following cessation of all exogenous hormonal\r\n                  treatments, had radiation-induced menopause with last menses > 1 year ago, had\r\n                  chemotherapy-induced menopause with last menses > 1 year ago, or underwent\r\n                  surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or\r\n                  hysterectomy)\r\n\r\n          -  Female subjects of childbearing potential should have a negative urine or serum\r\n             pregnancy within 72 hours prior to receiving the first dose of study medication. If\r\n             the urine test is positive or cannot be confirmed as negative, a serum pregnancy test\r\n             will be required\r\n\r\n          -  Female subjects of childbearing potential should be willing to use 1 method of highly\r\n             effective birth control or be surgically sterile, or abstain from heterosexual\r\n             activity for the course of the study through 180 days after the last dose of study\r\n             medication. Subjects of childbearing potential are those who have not been surgically\r\n             sterilized or have not been free from menses for > 1 year\r\n\r\n          -  Male subjects should agree to use an adequate method of contraception starting with\r\n             the first dose of study therapy through 180 days after the last dose of study therapy\r\n\r\n          -  Patient is >= 5 years free of another primary malignancy, except:\r\n\r\n               -  If the other malignancy is basal cell carcinoma or cervical carcinoma in situ or\r\n\r\n               -  If the other primary malignancy is not considered clinically significant and is\r\n                  requiring no active intervention\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Is currently participating in or has participated in a study of an investigational\r\n             agent or using an investigational device within 4 weeks of the first dose of treatment\r\n\r\n          -  Has a target lesion/s for SBRT that demonstrate any of the following:\r\n\r\n               -  Located within 2 cm of the proximal bronchial tree\r\n\r\n               -  > 5 cm (> 50 cc) in greatest dimension\r\n\r\n          -  Has a target lesion/s in a region that previously received high dose radiation therapy\r\n             (RT) (> 50 Gy) demonstrating any of the following:\r\n\r\n               -  Carotid artery encasement (> 180 degrees) (due to risk of carotid blow out)\r\n\r\n               -  Unprotected carotid artery (i.e. skin is directly over the carotid without\r\n                  intervening soft tissue, especially after prior neck dissection without a\r\n                  vascularized free flap) (due to risk of carotid blow out)\r\n\r\n               -  Skin infiltration by tumor (due to risk of fistula)\r\n\r\n               -  Located in the larynx/hypopharynx primaries (due airway threat)\r\n\r\n               -  Treated with high dose radiation therapy (> 50 Gy) within 6 months or less of\r\n                  trial enrollment\r\n\r\n          -  Prior receipt of an anti-PD-1, anti-PDL1 or anti-CTLA4 immune checkpoint inhibitor\r\n\r\n          -  Current or prior use of immunosuppressive medication within 14 days before the first\r\n             dose of nivolumab or ipilimumab. The following are exceptions to this criterion:\r\n\r\n               -  Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra\r\n                  articular injection)\r\n\r\n               -  Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of\r\n                  prednisone or its equivalent\r\n\r\n               -  Steroids as premedication for hypersensitivity reactions (e.g., computed\r\n                  tomography [CT] scan premedication)\r\n\r\n          -  Has received a prior monoclonal antibody within 4 weeks prior to study Day 1 or who\r\n             has not recovered (i.e., =< Grade 1 or at baseline) from adverse events due to agents\r\n             administered more than 4 weeks earlier\r\n\r\n          -  Has received prior chemotherapy, targeted small molecule therapy, or radiation therapy\r\n             within 2 weeks prior to study Day 1 or who has not recovered (i.e., =< Grade 1 or at\r\n             baseline) from adverse events due to a previously administered agent.\r\n\r\n               -  Note: Subjects with =< Grade 2 neuropathy are an exception to this criterion and\r\n                  may qualify for the study\r\n\r\n               -  Note: If subject received major surgery, they must have recovered adequately from\r\n                  the toxicity and/or complications from the intervention prior to starting therapy\r\n\r\n          -  Has a known additional malignancy that is progressing or requires active treatment.\r\n             Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the\r\n             skin, or in situ cervical cancer that has undergone potentially curative therapy\r\n\r\n          -  Has known brain metastases or spinal cord compression unless the patient is stable\r\n             (asymptomatic; no evidence of new or emerging brain metastases; and stable and off\r\n             steroids for at least 14 days prior to start of study treatment). Following\r\n             radiotherapy and/or surgery of the brain metastases patients must wait 4 weeks\r\n             following the intervention and before initiating study treatment with imaging to\r\n             confirm stability\r\n\r\n          -  Has an active autoimmune disease requiring systemic treatment within the past 2 years\r\n             or a documented history of clinically severe autoimmune disease, or a syndrome that\r\n             requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or\r\n             resolved childhood asthma/atopy would be an exception to this rule. Subjects that\r\n             require intermittent use of bronchodilators or local steroid injections would not be\r\n             excluded from the study. Subjects with hypothyroidism stable on hormone replacement\r\n             will not be excluded from the study\r\n\r\n          -  Has a history of or evidence of active interstitial lung disease or non-infectious\r\n             pneumonitis\r\n\r\n          -  Has an active infection requiring systemic therapy\r\n\r\n          -  Has a history or current evidence of any condition, therapy, or laboratory abnormality\r\n             that might confound the results of the trial, interfere with the subject's\r\n             participation for the full duration of the trial, or is not in the best interest of\r\n             the subject to participate, in the opinion of the treating investigator\r\n\r\n          -  Has known psychiatric or substance abuse disorders that would interfere with\r\n             cooperation with the requirements of the trial\r\n\r\n          -  Is pregnant or breastfeeding, or expecting to conceive or father children within the\r\n             projected duration of the trial, starting with the pre-screening or screening visit\r\n             through 180 days after the last dose of trial treatment\r\n\r\n          -  Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)\r\n\r\n          -  Has evidence of acute or chronic hepatitis B, or hepatitis C\r\n\r\n          -  Has received a live vaccine within 30 days prior to the first dose of trial treatment\r\n\r\n          -  Has a history of primary immunodeficiency or an allogeneic organ transplant\r\n\r\n          -  Known history of previous clinical diagnosis of tuberculosis\r\n\r\n          -  Uncontrolled intercurrent illness including, but not limited to symptomatic congestive\r\n             heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac\r\n             arrhythmia, active peptic ulcer disease or gastritis, seizures\r\n      ","sponsor":"University of Washington","sponsor_type":"Other","conditions":"Larynx|Lip|Oral Cavity Cancer|Pharynx Cancer","interventions":[{"intervention_type":"Biological","name":"Biological: Nivolumab","description":"Given IV"},{"intervention_type":"Biological","name":"Biological: Ipilimumab","description":"Given IV"},{"intervention_type":"Radiation","name":"Radiation: Stereotactic Body Radiation Therapy","description":"Undergo SBRT"}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of adverse events (AEs)","time_frame":"Up to 100 days post-treatment","description":"Adverse events will be recorded and graded based on Common Terminology Criteria for Adverse Events (CTCAE) version 5, and their relationship to the experimental agents reported."},{"outcome_type":"secondary","measure":"Objective response rate (ORR)","time_frame":"Up to 4 years","description":"Clinical responses to the combination of nivolumab, ipilimumab and hypofractionated radiation will be based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria."},{"outcome_type":"secondary","measure":"Progression-free survival (PFS)","time_frame":"From the date of study enrollment, until disease progression or death, assessed up to 4 years","description":"PFS estimate will be calculated using the Kaplan-Meier method."},{"outcome_type":"secondary","measure":"Overall survival (OS)","time_frame":"From the date of study enrollment, until disease progression or death, assessed up to 4 years","description":"OS estimate will be calculated using the Kaplan-Meier method."}]}
{"nct_id":"NCT03740620","start_date":"2019-01-14","phase":"N/A","enrollment":68,"brief_title":"The Effect of Bevel Direction on the Pathway of the Nasotracheal Tube","official_title":"The Effect of Bevel Direction on the Pathway of the Tracheal Tube in the Nasal Cavity During Nasotracheal Intubation: a Randomized Controlled Trial","primary_completion_date":"2020-01-26","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2020-01-26","last_update":"2019-09-23","description":"In this study, the subjects are divided into two groups (group I: intervention group = the nasotracheal tube inserted with the bevel of the nasal tube facing the direction of the patient's head, and Group II: conventional group = the bevel of the tube toward the left side of the subject). After the endotracheal tube is introduced, a flexible endoscope is used to evaluate whether the tube is located below the inferior turbinate, i.e. in the lower pathway.","other_id":"30-2018-76","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  a patient who will take operation which needs nasotracheal intubation under general\r\n             anesthesia\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  a patient who didn't agree to participate in this study\r\n\r\n          -  a patient who has a deformity of the nose\r\n\r\n          -  a patient who has a history of severe epistaxis\r\n\r\n          -  a patient who has coagulation problem\r\n\r\n          -  a patient who has a history of the fracture or surgery of the skull base\r\n      ","sponsor":"Seoul National University Hospital","sponsor_type":"Other","conditions":"Epistaxis|Intubation Complication","interventions":[{"intervention_type":"Procedure","name":"Procedure: Bevel facing the cephalad direction of the patient","description":"The bevel of the nasotracheal tube facing cephalad direction of the patient"},{"intervention_type":"Procedure","name":"Procedure: Bevel facing leftward of the patient","description":"The bevel of the nasotracheal tube facing the left side of the patient"}],"outcomes":[{"outcome_type":"primary","measure":"incidence of the tube in lower pathway","time_frame":"right after completion of the intubation","description":"incidence of tracheal tube passing through the lower pathway (beneath the inferior turbinate and immediately above the nasal floor of the nostril)"},{"outcome_type":"secondary","measure":"intubation time","time_frame":"from the start of the intubation to the completion of the intubation, which is confirmed by the appearance of end-tidal CO2 curve, up to 60 seconds","description":"time to complete endotracheal intubation"},{"outcome_type":"secondary","measure":"incidence and severity of epistaxis","time_frame":"right after completion of the intubation","description":"incidence and severity of epistaxis"}]}
{"nct_id":"NCT04430270","start_date":"2019-01-10","enrollment":11,"brief_title":"Perceptions of Orthopedic Prespecialists on Patient-Specific 3D Models.","official_title":"Ethical Committee at Researches of Ege University","primary_completion_date":"2019-06-10","study_type":"Observational","rec_status":"Completed","completion_date":"2020-05-10","last_update":"2020-06-16","description":"Background: Three-dimensional (3D) patient-specific anatomical model guidance is a reliable tool in obtaining accurate bony cuts, precise implant placement, and satisfactory surgical results. These can enhance surgeon's understanding of their patients' patho-anatomy also helping in precise preoperative planning. So, the hypothesis of this study is that, in the training of orthopaedic residency, 3D printed models reflecting the patient's individual process provide a a foresight and a perception of the bone pathologies and osseous relationships before orthopaedic intervention. Methods: In this study, the investigators displayed our experience of creating realistic 3D models in orthopaedic surgical case scenarios to evaluate the perceptions of fellows in orthopaedic surgeon training. The investigators based our study on the comparision of the perception of residents who were presented with four-step carousel consisting of different scenarios as trauma (calcaneal fracture), deformity (hallux valgus), tumoral mass (sacral chondrosarcoma), and reconstructive procedure (multidisciplinary cancer surgery). The X-ray images, computed tomography (CT), and 1:1 solid models of the cases were included in each step. The orthopaedic residents were asked to compare their perception level of the actual scenarios in evaluating the effectiveness of each tool in terms of perceiving the orthopaedic problem, understanding the bone pathology, classification of diagnosis and preoperative data planning.","other_id":"EGE18-5/41","observational_model":"Case-Control","time_perspective":"Retrospective","sampling_method":"Probability Sample","gender":"Male","minimum_age":24,"maximum_age":30,"population":"The study group consisted of 11 orthopaedic residents of University Hospital.","criteria":"\n        Inclusion Criteria:Calcaneal fracture, Sacral tumors, Hallux valgus deformity, Mediastinal\r\n        Tumors -\r\n\r\n        Exclusion Criteria:Tibial Fracture, Acetabular fracture, Femoral tumors, Pes planus\r\n\r\n        -\r\n      ","sponsor":"Ege University","sponsor_type":"Other","conditions":"Educational Problems","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Survey","description":"Sequential Assignment"}],"outcomes":[{"outcome_type":"primary","measure":"Creating life-size patient-specific orthopaedic surgery cases model","time_frame":"The research took 12 months, 05.02.2020, Each participant spends 45 minutes for the survey.","description":"A multi-item survey was prepared to assess fellow's perception of residency training. The survey utilized by our group, addressed the issues in understanding patient bone anatomy, seeing osseous pathology, independent decision-making, differential pathological diagnosis, plan on key surgical steps, and preparation for unexpected events. Residents who completed their examination in the stations evaluated each imaging method and answered the questions on a scale of 10. Scoring in the scale (1 - 10) describes 0 = very low and 10= the highest level.Descriptive statistics and Friedman test were used for comparison analysis. Data were analyzed using IBM SPSS Statistics, version 24 (IBM Corp., Armonk, NY)."}]}
{"nct_id":"NCT03690791","start_date":"2019-01-09","phase":"Phase 3","enrollment":30,"brief_title":"Efficacy of Cannabinoids in Amyotrophic Lateral Sclerosis or Motor Neurone Disease","official_title":"A Randomised, Double-blind, Single-centre Study on the Safety, Tolerability and Efficacy of Cannabis Based Medicine Extract (MediCabilis CBD Oil) in Slowing the Disease Progression in Amyotrophic Lateral Sclerosis or Motor Neurone Disease Patients","primary_completion_date":"2022-12-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-01-30","last_update":"2021-07-28","description":"This is a randomised, double-blind, placebo controlled study on a cannabis-based medicine extract (MediCabilis CBD Oil), in patients with Amyotrophic Lateral Sclerosis or Motor Neurone Disease. Participants will be randomised in a 1:1 ratio to receive MediCabilis CBD Oil or placebo oil. The treatment duration is 6 months with one-month safety follow up. Participants will be checked every month either face to face or via telephone and will be assessed to collect data for study objectives such as ALSFRS-R, Forced Vital Capacity, pain and spasticity score, and quality of life. Thirty (30) participants will be randomised.","other_id":"GCMR0001","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":25,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Affected by ALS/MND, either of definite or probable according to the El Escorial\r\n             revised criteria\r\n\r\n          2. Can provide written informed consent\r\n\r\n          3. Able and willing to comply with all study requirement\r\n\r\n          4. Male or female, ages 25-80 years old\r\n\r\n          5. Onset of first symptom within the last 2 years\r\n\r\n          6. Forced Vital Capacity (FVC) of at least 60% on baseline\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Participants who are bedridden\r\n\r\n          2. Have used or taken cannabis or cannabinoid-based medications within 30 days of study\r\n             entry\r\n\r\n          3. History of any psychiatric disorder other than depression associated with their\r\n             underlying condition including immediate family history of schizophrenia\r\n\r\n          4. Heavy consumption of alcohol or use of illicit drug\r\n\r\n          5. Hypersensitivity to cannabinoids or any of the excipients\r\n\r\n          6. Any of the following: eGFR <30 mL/min/1.73m2, ejection fraction <35%, or ASL and ALT\r\n             >5 X ULN\r\n\r\n          7. Unwillingness of a female participant of child bearing potential, or their partner, to\r\n             use effective contraception during the study and 30 days thereafter\r\n\r\n          8. Pregnant, lactating mother or female participant planning pregnancy during the course\r\n             of the study and for 30 days thereafter\r\n\r\n          9. Received any investigational drug or medical device within 30 days prior randomisation\r\n\r\n         10. Any other significant disease or disorder which, in the opinion of the investigator,\r\n             may either put the participant at risk because of participation in the study, or may\r\n             influence the result of the study, or the participant's ability to participate in the\r\n             study\r\n\r\n         11. Inability to cooperate with the study procedures\r\n\r\n         12. Unwilling to stop driving vehicle or operating dangerous machinery whilst on study\r\n             drug.\r\n\r\n         13. Close affiliation with the study team, e.g. close relative of the investigator\r\n      ","sponsor":"Gold Coast Hospital and Health Service","sponsor_type":"Other","conditions":"Amyotrophic Lateral Sclerosis|Motor Neuron Disease","interventions":[{"intervention_type":"Drug","name":"Drug: MediCabilis CBD Oil","description":"50 mg of CBD: <2mg of THC in one ml. The cannabis oil consists of CBD extract in MCT oil."},{"intervention_type":"Drug","name":"Drug: Placebo Oil","description":"Placebo will contain only hemp seed oil."}],"outcomes":[{"outcome_type":"primary","measure":"Difference in mean ALS Functional Rating Scale-Revised (ALSFRS-R) total score between groups at end of treatment (Total score: min 0- max 48) [efficacy]","time_frame":"Baseline to Day 180","description":"Change from baseline in ALS functional rating total scores on the ALSFRS-R at 24 weeks. Total score ranges from 0 to 48. Higher value represents better outcome."},{"outcome_type":"primary","measure":"Difference in mean Forced Vital Capacity (FVC) volume between groups at end of treatment [efficacy]","time_frame":"Baseline to Day 180","description":"Change from baseline in Forced Vital Capacity volume on the Lung Function Test at 24 weeks"},{"outcome_type":"secondary","measure":"Nature and number of adverse events [safety and tolerability]","time_frame":"Baseline to Day 180","description":"Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 at 24 weeks"},{"outcome_type":"secondary","measure":"Difference in mean Numeric Rating Scale for spasticity total score between groups at end of treatment (Scores 0-100)","time_frame":"Baseline to Day 180","description":"Change from baseline in spasticity total score on the Numeric Rating Scale for spasticity at 24 weeks. Total score ranges from 0 to 100. Higher values represent better outcome."},{"outcome_type":"secondary","measure":"Difference in mean Numeric Rating Scale for pain total score between groups at end of treatment (Total score min:1-max:100)","time_frame":"Baseline to Day 180","description":"Change from baseline in pain total score on the Numeric Rating Scale for pain at 24 weeks. Total score ranges from 0 to 100. Higher value represents better outcome."},{"outcome_type":"secondary","measure":"Difference in mean Percentage of Total Weight Loss score between groups at end of treatment (Percentage score min: 0- max: 100)","time_frame":"Baseline to Day 180","description":"Change from baseline in weight loss on the Percentage of Total Weight Loss at 24 weeks. Percentage ranges from 0 to 100. Higher value represents better outcome."},{"outcome_type":"secondary","measure":"Difference in mean ALS Specific Quality of Life- Revised (ALSSQOL-R) total score between groups at end of treatment (Total score min:0- max:460)","time_frame":"Baseline to Day 180","description":"Change from baseline in quality of life total score on the ALS Specific Quality of Life- Revised (ALSSQOL-R) score at 24 weeks. Total score ranges from 0 to 460. Higher score represent better outcome."},{"outcome_type":"other","measure":"Difference in mean Edinburgh Cognitive and Behavioural ALS Screen (ECAS) total score between groups at end of treatment (Score 0-136)","time_frame":"Baseline to Day 180","description":"Change from baseline in quality of life total score on the ALS Specific Quality of Life- Revised (ALSSQOL-R) total score at 24 weeks. Total score ranges from 0 to 100. Higher score represent better outcome."}]}
{"nct_id":"NCT03539497","start_date":"2019-01-08","enrollment":100,"brief_title":"Prognostic Value of Plasma Mitochondrial DNA and Cytochrome C After Cardiac Arrest","official_title":"Prognostic Value of Plasma Mitochondrial DNA and Cytochrome C After Cardiac Arrest","primary_completion_date":"2019-12-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2020-06-30","last_update":"2019-01-09","description":"The aim of the study is to determine prognostic value of plasma mitochondrial DNA and cytochrome C after cardiac arrest. The study will be conducted in three parts: 1. Determine plasma concentrations of mitochondrial DNA and cytochrome C in healthy population. 2. Determine release profile of mitochondrial DNA and cytochrome C to plasma after cardiac arrest. 3. Determine plasma prognostic value of mitochondrial DNA and cytochrome C after cardiac arrest and compare it with established prognostic methods.","other_id":"UKC-KOIIM-c-arrest","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":14,"population":"Unconscious patients after cardiac arrest treated with therapeutic hypothermia.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  unconscious after cardiac arrest\r\n\r\n          -  therapeutic hypothermia\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  expected survival less than 24h\r\n      ","sponsor":"University Medical Centre Ljubljana","sponsor_type":"Other","conditions":"Cardiac Arrest","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Biomarker","description":"Plasma mitochondrial DNA, plasma Cytochrome C"}],"outcomes":[{"outcome_type":"primary","measure":"Correlation of plasma mitochondrial DNA and cytochrome C with survival with good neurological outcome (CPC 1 and 2) at hospital discharge","time_frame":"In hospital mortality, 30days","description":"Relationship between plasma mitochondrial DNA and cytochrome C with neurological damage after cardiac arrest"}]}
{"nct_id":"NCT03797859","start_date":"2019-01-08","enrollment":36,"brief_title":"THRIVE Apneic Ventilation With Standardized Airway Management During General Anesthesia.","official_title":"Apneic Oxygenation With Transnasal Humidified Rapid Insufflation Ventilatory Exchange (THRIVE) With Standardized Airway Management During General Anesthesia - an Observational Study of Blood Gas Dynamics of PaCO2, pH and PaO2.","primary_completion_date":"2019-05-01","study_type":"Observational","rec_status":"Unknown status","completion_date":"2019-06-01","last_update":"2019-01-23","description":"Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) denotes the use of high-flow humidified nasal oxygen system (for example Optiflow) as an alternative ventilation modality for an anesthetized patient without spontaneous respiration. This method requires only basic airway management manoeuvres to keep the airway open and provides both stable longterm oxygenation as well as apneic ventialtion. We plan to evaluate this methods physiological performance under standardized conditions of airway management by frequent, repeated arterial blood gas analyses.","other_id":"H-18017844","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients presenting for non-laryngeal surgery in general anesthesia, where intubation is\r\n        not mandatory.","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Adult (age over 18 years)\r\n\r\n          2. Elective surgery where intubation is not mandatory\r\n\r\n          3. The patient can understand the information about the study and give their informed\r\n             written consent of participation\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. ASA (American Society of Anaesthesiologists class) > 3\r\n\r\n          2. NYHA (New York Heart Association class) > 2\r\n\r\n          3. BMI > 30 kg/m2\r\n\r\n          4. Symptomatic respiratory disease\r\n\r\n          5. Symptomatic cardiac disease\r\n\r\n          6. Evidence of arteriosclerotic disease\r\n\r\n          7. Neuromuscular disease\r\n\r\n          8. Pregnancy\r\n\r\n          9. Presumed or predicted difficult airway (SARI - Simplified Airway Risk Index score > 4)\r\n\r\n         10. Known or suspected nasal congestion/stenosis or catharalia\r\n      ","sponsor":"Rigshospitalet, Denmark","sponsor_type":"Other","conditions":"Apnea|Ventilation Therapy; Complications|Respiratory Acidosis","interventions":[{"intervention_type":"Procedure","name":"Procedure: Apneic ventilation","description":"Ventilation by THRIVE"}],"outcomes":[{"outcome_type":"primary","measure":"Respiratory acidosis","time_frame":"Max. 60 minutes","description":"Development of respiratory acidosis (pH < 7.15 or paCO2 > 12) over time on study"}]}
{"nct_id":"NCT03788135","start_date":"2019-01-05","phase":"N/A","enrollment":50,"brief_title":"Localized Muscle Cooling on Balance in Healthy Individuals","official_title":"Effect of Localized Muscle Cooling on Balance in Healthy Individuals","primary_completion_date":"2019-04-25","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-05-15","last_update":"2019-08-14","description":"This study aims to investigate the effects of localized muscle cooling on static and dynamic stability in healthy adults.","other_id":"RRC-2018-011","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"Double","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":30,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy young adults\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  history of a hip or knee injury, sensory deficits in the lower extremity and lower\r\n             back, a history of lower-extremity surgery, spinal surgery, or a history of a\r\n             quadriceps or hamstring muscle injury.\r\n      ","sponsor":"King Saud University","sponsor_type":"Other","conditions":"Healthy","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: cooling","description":"the participants in the experimental group will receive a cold pack (gel pack, temperature -6 degrees to -12 degrees Celsius) will be placed on the target muscles for 20 minutes."}],"outcomes":[{"outcome_type":"primary","measure":"mean center of gravity (COG) sway velocity (degrees/sec) for the unilateral Stance (US)","time_frame":"up to 3 weeks","description":"The participants will be asked to stood in the marked position on the force plate, with their hands positioned on the iliac crests. The participants will be requested to lift the right foot to a standard height of 10 cm. This 10-second test will be performed three times in two test conditions, including eyes open (EO) and eyes closed (EC). The mean COG sway velocity (degrees/sec) from three trials of the US will be used in the analysis. The participants will be requested to perform the same test for the left leg. The US will be used to determine each participant's ability to maintain postural stability during unilateral standing in the EO and EC conditions."}]}
{"nct_id":"NCT04460898","start_date":"2019-01-04","enrollment":1,"brief_title":"RW Treatment Patterns and Outcomes in Postmenopausal HR+/HER2- mBC Patients Treated With Palbociclib Plus Letrozole as Initial Endocrine Therapy at Community Oncology Practices in the U.S.","official_title":"Real-World Treatment Patterns and Outcomes in Postmenopausal, Hormone-Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative, Metastatic Breast Cancer Patients Treated With Palbociclib Plus an Letrozole as Initial Endocrine Therapy at Community Oncology Practices in the U.S.","primary_completion_date":"2019-06-24","study_type":"Observational","rec_status":"Completed","completion_date":"2019-06-24","last_update":"2020-07-08","description":"This is a retrospective, observational study that will document treatment patterns and clinical outcomes of postmenopausal patients diagnosed with HR+/HER2- mBC who received Palbociclib plus Letrozole as initial endocrine-based therapy in US community oncology network settings.","other_id":"A5481123","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"Female","minimum_age":18,"population":"The study will include adult patients aged 18 years and older, diagnosed with HR+/HER2- mBC\r\n        and received treatment with Palbociclib in combination with letrozole as initial\r\n        endocrine-therapy for advanced/metastatic breast cancer.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients must meet all of the following inclusion criteria to be eligible for\r\n             inclusion in the study:\r\n\r\n               1. Diagnosed with locoregional recurrent or metastatic female breast cancer.\r\n\r\n               2. Pathologically confirmed HR-positive/HER2-negative diagnosis.\r\n\r\n               3. Received treatment with palbociclib in combination with letrozole as initial\r\n                  endocrine-based therapy for advanced/metastatic breast cancer:\r\n\r\n                    1. Initiated treatment with palbociclib at least 3 months following the\r\n                       provider's first use of palbociclib following its FDA approval.\r\n\r\n                    2. At least 1 month of follow-up (at least one visit with the provider) after\r\n                       initiation of palbociclib.\r\n\r\n               4. Postmenopausal (or receiving surgical or medical treatment to induce menopause)\r\n                  at the time of initiation of palbociclib.\r\n\r\n               5. 18 year old at initiation of palbociclib.\r\n\r\n                  Exclusion Criteria:\r\n\r\n          -  No exclusion criteria will be imposed for the selection of patients.\r\n      ","sponsor":"Pfizer","sponsor_type":"Industry","conditions":"Breast Cancer","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Progression Free Survival (PFS)","time_frame":"mBC diagnosis through end of study (assessed up to 24 months)"},{"outcome_type":"primary","measure":"Tumor response","time_frame":"mBC diagnosis through end of study (assessed up to 24 months)"},{"outcome_type":"primary","measure":"Proportion of patients receiving various cancer treatment regimens","time_frame":"mBC diagnosis through end of study (assessed up to 24 months)"},{"outcome_type":"primary","measure":"Proportion of patients receiving each therapy sequence across lines","time_frame":"mBC diagnosis through end of study (assessed up to 24 months)"},{"outcome_type":"primary","measure":"Proportion of patients receiving each starting dose and end dose for those on palbociclib combination therapy","time_frame":"mBC diagnosis through end of study (assessed up to 24 months)"},{"outcome_type":"primary","measure":"Proportion of patients that experienced dose adjustment","time_frame":"mBC diagnosis through end of study (assessed up to 24 months)"},{"outcome_type":"primary","measure":"Proportion of patients that discontinued therapy","time_frame":"mBC diagnosis through end of study (assessed up to 24 months)"}]}
{"nct_id":"NCT04258163","start_date":"2019-01-01","enrollment":760,"brief_title":"Association of Survival With Maintenance Therapy in Patients With Metastatic Breast Cancer After First-line Chemotherapy","official_title":"Association of Survival With Maintenance Therapy in Patients With Metastatic Breast Cancer After First-line Chemotherapy","primary_completion_date":"2019-06-01","study_type":"Observational","rec_status":"Completed","completion_date":"2019-07-01","last_update":"2020-02-10","description":"To investigate the benefits and risks of maintenance chemotherapy (MCT), maintenance endocrine therapy (MET) and none maintenance therapy after first-line treatment of metastatic breast cancer (MBC).","other_id":"SYSEC-KY-KS-2019-099","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"Female","minimum_age":18,"maximum_age":75,"population":"This is a multi-center real world study to compare maintenance chemotherapy (MCT),\r\n        maintenance endocrine therapy (MET) and observation in patients with HR-positive MBC who\r\n        achieved disease control after first-line chemotherapy. Patients were retrospectively\r\n        enrolled from 3 different medical center.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with pathologically clear invasive breast cancer between 2003 and 2018;\r\n\r\n          -  Female,18-75 years old;\r\n\r\n          -  Measurable metastatic lesion according to RECIST 1.1 evaluation criteria;\r\n\r\n          -  The first-line chemotherapy regimen is a breast cancer combination or single-agent\r\n             chemotherapy regimen recommended by the NCCN guidelines;\r\n\r\n          -  First-line chemotherapy is effective (according to RECIST1.1 evaluation criteria, the\r\n             efficacy is evaluated as complete response (CR), partial response (PR), or steady\r\n             state (SD));\r\n\r\n          -  After the last cycle of first-line chemotherapy, patients should still be in a state\r\n             of no progress for at least 4 weeks;\r\n\r\n          -  Patients' Karnofsky performance status (KPS) scores were 70.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Unmeasurable metastatic lesion according to RECIST 1.1 evaluation criteria.\r\n      ","sponsor":"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","sponsor_type":"Other","conditions":"Metastatic Breast Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Capecitabine","description":"1000-1250 mg/m 2 PO twice daily days 1-14, cycled every 28 days"},{"intervention_type":"Drug","name":"Drug: Liposomal doxorubicin","description":"50 mg/m 2 IV day 1, cycled every 28 days"},{"intervention_type":"Drug","name":"Drug: Gemcitabine","description":"800-1200 mg/m 2 IV days 1, 8, and 15, cycled every 28 days"},{"intervention_type":"Drug","name":"Drug: Fulvestrant","description":"500mg IH Days 0, 14, 28, then every 28 days"},{"intervention_type":"Drug","name":"Drug: Anastrozole","description":"1mg PO qd"},{"intervention_type":"Drug","name":"Drug: Letrozole","description":"2.5mg PO qd"}],"outcomes":[{"outcome_type":"primary","measure":"Overall Survival (OS)","time_frame":"Estimated 36 months","description":"From enrollment to death (for any reason)"},{"outcome_type":"secondary","measure":"Progression free survival (PFS)","time_frame":"Estimated 18 months","description":"From enrollment to progression or death (for any reason)"}]}
{"nct_id":"NCT03845153","start_date":"2019-01-01","phase":"Phase 4","enrollment":40,"brief_title":"Metformin Effect on Fracture Healing in Post-Menopausal Women","official_title":"Study of Metformin Drug Effect on Fracture Healing in Post-Menopausal Women and Its Correlation to Serum Irisin Myokine Level.","primary_completion_date":"2021-01-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2021-01-01","last_update":"2021-02-09","description":"study the effect of metformin drug on fracture healing of patients with high risk of delayed fracture healing or non-union and correlating this to serum irisin myokine level.","other_id":"Metformin on Fracture healing","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","intervention_model_description":"40 post-menopausal women with a bone fracture divided into two groups each of 20, randomly assigned to administration with metformin Retard 850 mg once daily for two weeks then 850 mg twice daily or with placebo.","sampling_method":"","gender":"Female","minimum_age":55,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age range from 55 to less than 65 years old with bone fracture.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Age equal or less than 55 years\r\n\r\n          -  Age equal or more than 65 years\r\n\r\n          -  Unstable or hospitalized patients with heart failure\r\n\r\n          -  Hepatic impairment\r\n\r\n          -  Chronic kidney disease with eGFR <45 mL/minute/1.73 m2\r\n\r\n          -  Open fractures\r\n\r\n          -  Pathological fractures\r\n\r\n          -  Diabetic patients\r\n      ","sponsor":"Damanhour University","sponsor_type":"Other","conditions":"Bone Fracture","interventions":[{"intervention_type":"Drug","name":"Drug: Metformin Retard 850 mg","description":"tablet"},{"intervention_type":"Other","name":"Other: Placebo","description":"placebo tablet"}],"outcomes":[{"outcome_type":"primary","measure":"Human Irisin (ng/ml)","time_frame":"three months","description":"myokine/adipokine"},{"outcome_type":"primary","measure":"Bone specific alkaline phosphatase (IU/L)","time_frame":"three months","description":"isoenzyme produced by osteoblasts involved with calcification of skeleton and bone formation"},{"outcome_type":"primary","measure":"postoperative X-rays - Lane and Sandhu radiological scoring system","time_frame":"two months post stabilization.","description":"evaluate the degree of new bone formation in the fracture line on anterior-posterior and lateral radiographs"}]}
{"nct_id":"NCT03480490","start_date":"2019-01-01","enrollment":25,"brief_title":"Evaluation and Outcome of Para-pneumonic Effusion","official_title":"Evaluation and Outcome of Para-pneumonic Effusion Among Children Attending Assuit University Pediatric Hospital","primary_completion_date":"2020-01-01","study_type":"Observational","rec_status":"Unknown status","completion_date":"2020-05-31","last_update":"2018-03-29","description":"Pleural effusion is the accumulation of excess fluid in the pleural cavity, which results in disturbance of the equilibrium between vascular hydrostatic and oncotic pressures. The underlying causes of pleural effusion include pleural inflammation or infection, congestive heart failure, lymphatic drainage blockage and malignancy.A parapneumonic effusion is a pleural effusion associated with lung infection. Early in the course of parapneumonic effusion, the pleura becomes inflamed with leakage of cellular elements, protein, and fluid into the pleural space, forming the effusion. Subsequent bacterial invasion results in a frank empyema, the presence of which often requires thoracentesis.","other_id":"EOPE","observational_model":"Case-Only","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":0.08333,"maximum_age":18,"population":"This study was conducted on patients with para-pneumonic effusion who were admitted to the\r\n        Assiut University Pediatrics Hospital in the period between january 2019 and january 2020.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  This study will be conducted upon patients(male and females),from 1 month to 18 years\r\n             with para-pneumonic effusion at assuit university pediatric hospital from January to\r\n             june 2019 after taking consents.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  age: >18 years old congenital heart disease lymphatic drainage blockage post traumatic\r\n             pleural effusion renal diseases hepatic diseases neoplastic diseases\r\n      ","sponsor":"Assiut University","sponsor_type":"Other","conditions":"Pleural Effusion","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Pleural fluid C-reactive protein","description":"C-reactive protein is an acute phase protein that is synthesized by the liver in response to various stimuli.\r\nThe pleural fluid c-reactive protein levels are likely to reflect the serum levels because the presence of c-reactive protein in the pleural fluid may be due to increased diffusion from the blood as a result of inflamed capillary leakage.\r\nPleural c-reactive protein has been proposed as a specific biomarker for the differential diagnosis of pleural effusions and reportedly exhibits higher sensitivity and specificity than serum c-reactive protein.\r\nc-reactive protein can be considered a good candidate due to its 1000-fold elevation in response to infection and the positive correlation between the serum and pleural c-reactive protein levels.\r\nPleural fluid c-reactive protein level was significantly higher in exudates than that in transudative effusion."}],"outcomes":[{"outcome_type":"primary","measure":"cure rate from effusion","time_frame":"baseline","description":"to evaluate the cure rate from para-pneumonic effusion among children"}]}
{"nct_id":"NCT03086902","start_date":"2018-12-31","phase":"N/A","enrollment":88,"brief_title":"Comparision of PVC Ablation Techniques","official_title":"Cryo Ablation vs. Radiofrequency Catheter Ablation for Ventricular Premature Contractions","primary_completion_date":"2020-07-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2021-07-31","last_update":"2018-06-06","description":"Several reports have shown the utility of PVC ablation with cryo catheters. The aim of this study is to compare the outcomes and safety of Cryo vs. RF for PVCs.","other_id":"SMC-3991-17","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Group sample sizes of 44 in Group 1 and 44 in Group 2 achieve 80% power to detect a difference between the group proportions of -0.2000. The proportion in Group 1 (the treatment group) is assumed to be 0.2500 under the null hypothesis and 0.0500 under the alternative hypothesis. The proportion in Group 2 (the control group) is 0.2500. The test statistic used is the two-sided Z test with pooled variance. The significance level of the test was targeted at 0.0500. The significance level actually achieved by this design is 0.0531.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion criteria:\r\n\r\n          1. Patients referred for PVC ablation.\r\n\r\n          2. Age  18 years on a date of consent.\r\n\r\n        Exclusion criteria:\r\n\r\n          1. Contraindications for ablation\r\n\r\n          2. Serious known concomitant disease with a life expectancy of < 1 year\r\n\r\n          3. Elderly patients >80 years of age\r\n\r\n          4. Pregnancy or nursing\r\n\r\n          5. Unwilling or unable to give informed consent\r\n      ","sponsor":"Sheba Medical Center","sponsor_type":"Other","conditions":"Premature Ventricular Contraction","interventions":[{"intervention_type":"Device","name":"Device: Radiofrequency Ablation Catheter","description":"Ablation of PVC with RF energy"},{"intervention_type":"Device","name":"Device: Cryo Ablation catheter","description":"Ablation pf PVC with Cryo enerygy"}],"outcomes":[{"outcome_type":"primary","measure":"Comparison of successful catheter ablation between both methods.","time_frame":"During procedure and 1 month follow up","description":"Successful ablation will be defined as absence of clinical VA or > 50% reduction in arrhythmia burden on Holter in the absence of anti-arrhythmic medication."},{"outcome_type":"secondary","measure":"Comparison of complications such as pericardial effusion/ tamponade, coronary artery damage and post procedure pericardial pain requiring medical management.","time_frame":"During Procedure","description":"Any complication will be assessed clinically during procedure and managed as indicated."},{"outcome_type":"secondary","measure":"Comparison of procedure and fluoroscopy time between both strategies","time_frame":"During Procedure","description":"Time of procedure and fluoroscopy will be logged into CRF"}]}
{"nct_id":"NCT03785522","start_date":"2018-12-23","enrollment":597,"brief_title":"A Research Study, Looking at How Tresiba Works in People With Type 2 Diabetes in Local Clinical Practice in Saudi Arabia","official_title":"A Prospective Non-interventional Study Investigating the Treatment Effect of Tresiba in Adult Patients With Type 2 Diabetes in Saudi Arabia","primary_completion_date":"2020-11-30","study_type":"Observational","rec_status":"Completed","completion_date":"2020-11-30","last_update":"2021-06-04","description":"The purpose of the study is to collect information on how Tresiba works in real world patients. Patients will get Tresiba as prescribed to them by their study doctor. The study will last for about 6 to 8 months. Patients will be asked questions about their health and diabetes treatment as part of their normal study doctor's appointment.","other_id":"NN1250-4440","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients with type 2 diabetes in Saudi Arabia treated with any antihyperglycaemic\r\n        medication(s), except Tresiba, are eligible for this study.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Signed consent obtained before any study-related activities (study-related activities\r\n             are any procedure related to recording of data according to the protocol)\r\n\r\n          -  The decision to initiate treatment with commercially available Tresiba has been made\r\n             by the patient/legally acceptable representative and the treating physician before and\r\n             independently from the decision to include the patient in this study\r\n\r\n          -  Male or female, age above or equal to 18 years at the time of signing informed consent\r\n\r\n          -  Diagnosed with type 2 diabetes and treated with any antihyperglycaemic medication(s),\r\n             except Tresiba, for at least 26 weeks prior to Informed consent and Initiation Visit\r\n             (Visit 1)\r\n\r\n          -  Available and documented HbA1c value measured within the last 12 weeks prior to\r\n             initiation of Tresiba treatment\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Previous participation in this study. Participation is defined as having given\r\n             informed consent in this study\r\n\r\n          -  Mental incapacity, unwillingness or language barriers precluding adequate\r\n             understanding or cooperation\r\n\r\n          -  Hypersensitivity to the active substance or to any of the excipients as specified in\r\n             the Tresiba local label\r\n      ","sponsor":"Novo Nordisk A/S","sponsor_type":"Industry","conditions":"Diabetes Mellitus, Type 2","interventions":[{"intervention_type":"Drug","name":"Drug: Insulin degludec","description":"Patients will be treated with commercially available Tresiba in a pre-filled pen injector (FlexTouch) according to routine clinical practice at the discretion of the study doctor and in accordance with the local label. The study doctor will determine the starting dose of Tresiba as well as any dose adjustments thereafter."}],"outcomes":[{"outcome_type":"primary","measure":"Change in glycated haemoglobin (HbA1c) (percentage)","time_frame":"Week 0 (baseline), Week 26 (end of study)","description":"Measured in percentage. Baseline is defined as a period of less than or equal to 12 weeks prior to treatment initiation (week 0). If multiple values are available, the most recent one will be used for the baseline. End of study is defined as the first visit within the window from week 26 to week 34. If multiple values are available for a specific endpoint, the most recent one, relative to the end of study visit will be used."},{"outcome_type":"primary","measure":"Change in HbA1c (mmol/mol)","time_frame":"Week 0 (baseline), Week 26 (end of study)","description":"Measured in mmol/mol. Baseline is defined as a period of less than or equal to 12 weeks prior to treatment initiation (week 0). If multiple values are available, the most recent one will be used for the baseline. End of study is defined as the first visit within the window from week 26 to week 34. If multiple values are available for a specific endpoint, the most recent one, relative to the end of study visit will be used."},{"outcome_type":"secondary","measure":"Change in fasting plasma glucose (FPG) (mg/dL)","time_frame":"Week 0 (baseline), Week 26 (end of study)","description":"Measured in mg/dL. Baseline is defined as a period of less than or equal to 12 weeks prior to treatment initiation (week 0). If multiple values are available, the most recent one will be used for the baseline. End of study is defined as the first visit within the window from week 26 to week 34. If multiple values are available for a specific endpoint, the most recent one, relative to the end of study visit will be used."},{"outcome_type":"secondary","measure":"Change in FPG (mmol/L)","time_frame":"Week 0 (baseline), Week 26 (end of study)","description":"Measured in mmol/L. Baseline is defined as a period of less than or equal to 12 weeks prior to treatment initiation (week 0). If multiple values are available, the most recent one will be used for the baseline. End of study is defined as the first visit within the window from week 26 to week 34. If multiple values are available for a specific endpoint, the most recent one, relative to the end of study visit will be used."},{"outcome_type":"secondary","measure":"Change in daily insulin doses: Basal insulin","time_frame":"Week 0 (baseline), Week 26 (end of study)","description":"Measured in units/day. Baseline dose is defined as the most recent dose prior to treatment initiation (week 0). End of study is defined as the first visit within the window from week 26 to week 34. If multiple values are available for a specific endpoint, the most recent one, relative to the end of study visit will be used."},{"outcome_type":"secondary","measure":"Change in daily insulin doses: Prandial insulin","time_frame":"Week 0 (baseline), Week 26 (end of study)","description":"Measured in units/day. Baseline dose is defined as the most recent dose prior to treatment initiation (week 0). End of study is defined as the first visit within the window from week 26 to week 34. If multiple values are available for a specific endpoint, the most recent one, relative to the end of study visit will be used."},{"outcome_type":"secondary","measure":"Change in daily insulin doses: Total insulin","time_frame":"Week 0 (baseline), Week 26 (end of study)","description":"Measured in units/day. Baseline dose is defined as the most recent dose prior to treatment initiation (week 0). End of study is defined as the first visit within the window from week 26 to week 34. If multiple values are available for a specific endpoint, the most recent one, relative to the end of study visit will be used."},{"outcome_type":"secondary","measure":"Change in number of patient reported overall non-severe hypoglycaemic episodes","time_frame":"Week -4 to 0, week 22 to 26","description":"Number of episodes occurring within 4 weeks prior to initiation of treatment with Tresiba® and within 4 weeks prior to end of study. Non-severe hypoglycaemia is defined as an episode with symptoms and/or self-measured blood glucose (SMBG) value less than or equal to 3.9 mmol/L."},{"outcome_type":"secondary","measure":"Change in number of patient reported nocturnal non-severe hypoglycaemic episodes","time_frame":"Week -4 to 0, week 22 to 26","description":"Number of episodes occurring within 4 weeks prior to initiation of treatment with Tresiba® and within 4 weeks prior to end of study. The definition of \"nocturnal\" will be based on the patient's perception of whether or not it was night, i.e. the answer to this question to the patient: \"How many of these occurred between midnight and early morning\"?"},{"outcome_type":"secondary","measure":"Change in number of patient reported severe hypoglycaemic episodes (overall)","time_frame":"Week -26 to 0, week 0 to 26","description":"Number of episodes occurring within 26 weeks prior to initiation of treatment with Tresiba® and within 26 weeks prior to end of study. Severe hypoglycaemia is defined as an episode of hypoglycaemia requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective action. The patient should be asked: \"Were you able to treat yourself?\", if assistance from another person was required the episode can be defined as severe."},{"outcome_type":"secondary","measure":"Reason(s) for discontinuing treatment with Tresiba® during the treatment period, if applicable","time_frame":"Week 26","description":"Pre-specified response option(s) after initiation of treatment with Tresiba® until treatment discontinuation."}]}
{"nct_id":"NCT03681028","start_date":"2018-12-19","phase":"Phase 1","enrollment":15,"brief_title":"Feasibility of Individualized Therapy for Recurrent GBM","official_title":"Pilot Study Testing Feasibility of Individualized Therapy for Recurrent Glioblastoma","primary_completion_date":"2021-03-15","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2026-01-31","last_update":"2021-05-03","description":"The current study will test the ability and likelihood of successfully implementing individualized combination treatment recommendations for adult patients with surgically-resectable recurrent glioblastoma in a timely fashion. Collected tumor tissue and blood will be examined using a new diagnostic testing called University of California, San Francisco (UCSF) 500 Cancer Gene Panel which is done at the UCSF Clinical Cancer Genomics Laboratory. The UCSF 500 Cancer Gene Panel will help identify genetic changes in the DNA of a patient's cancer, which helps oncologists improve treatment by identifying targeted therapies.","other_id":"18108","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patient age must be >= 18 years\r\n\r\n          2. Patients must understand and provide written informed consent and Health Insurance\r\n             Portability and Accountability Act of 1996 (HIPAA) authorization authorization prior\r\n             to initiation of any study-specific procedures\r\n\r\n          3. Patients must have recurrence of histologically-proven glioblastoma or gliosarcoma,\r\n             World Health Organization (WHO) grade IV that is surgically resectable.\r\n\r\n          4. The patient's surgeon thinks that they can resect at least 500 mg of tumor.\r\n\r\n          5. Patient must have Karnofsky Performance Scale (KPS) score >=70\r\n\r\n          6. Patient must have an estimated life expectancy  3 months\r\n\r\n          7. Patients may enroll independent of number of prior therapies or cumulative doses of\r\n             prior therapies, but must have received appropriate prior therapy for GBM at time of\r\n             initial diagnosis, including radiation therapy.\r\n\r\n          8. Patient must have adequate bone marrow function, renal function, and hepatic function\r\n             as defined below:\r\n\r\n             Adequate bone marrow function:\r\n\r\n               1. absolute neutrophil count (ANC) >= 1,500/L\r\n\r\n               2. Platelets >= 100,000/L\r\n\r\n             Adequate hepatic function:\r\n\r\n               1. total bilirubin <= 1.5x institutional upper limit of normal\r\n\r\n               2. Aspartate aminotransferase (AST) /serum glutamic-oxaloacetic transaminase (SGOT)\r\n                  <= 2.5x institutional upper limit of normal\r\n\r\n               3. Alanine aminotransferase (ALT) / serum glutamic-pyruvic transaminase (SGPT) <=\r\n                  2.5x institutional upper limit of normal\r\n\r\n             Adequate renal function:\r\n\r\n             a. creatinine <= 1.5x institutional upper limit of normal OR creatinine clearance >=\r\n             60 mL/min/1.73 m2\r\n\r\n          9. Must be able to undergo MRI scans for tumor evaluation.\r\n\r\n         10. Women of child-bearing potential must have a negative pregnancy test (urine or serum)\r\n             within 7 days prior to surgery.\r\n\r\n             The effects of study drugs, either individually or their combination on the developing\r\n             human fetus are unknown. For this reason, women of child-bearing potential and men\r\n             must agree to use adequate contraception prior to study entry and for the duration of\r\n             study participation and for 3 months after completion of study drug administration.\r\n             The use of adequate contraception may be longer than 3 months depending on the drugs\r\n             used and the FDA-approved labeling in cases of recommendation for contraception.\r\n             Adequate contraception may include hormonal contraception, barrier method (condom,\r\n             contraceptive sponge, diaphragm or ring), intrauterine device (IUD), tubal ligation,\r\n             vasectomy and abstinence. Should a woman become pregnant (or suspect that she is\r\n             pregnant) while she or her partner is participating in this study, she should inform\r\n             her treating physician immediately. Men treated or enrolled on this protocol must also\r\n             agree to use adequate contraception prior to the study, for the duration of study\r\n             participation, and 3 months after completion of study drug administration. Patient\r\n             must not be a woman who is currently pregnant, due to the potential for teratogenic or\r\n             abortifacient effects of study drugs, either alone or in combination. Because there is\r\n             an unknown but potential risk of adverse events in nursing infants secondary to\r\n             treatment of the mother with study drugs, lactating women who are breastfeeding should\r\n             discontinue breastfeeding if the mother is treated with any study drug.\r\n\r\n         11. Patients must not have New York Heart Association (NYHA) Grade II or greater\r\n             congestive heart failure\r\n\r\n         12. Patients must not have history of myocardial infarction or unstable angina within 12\r\n             months prior to study enrollment.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patient who has been treated with any chemotherapy or radiotherapy 4 weeks prior to\r\n             date of study registration. Exceptions to this include: must be  23 days from last\r\n             dose of temozolomide (TMZ), must be  6 weeks from last dose of nitrosurea.\r\n\r\n          2. Patient who has not recovered to grade 1 or baseline from the adverse effects of prior\r\n             radiotherapy or chemotherapy.\r\n\r\n          3. Patient who is < 12 weeks from initial course of radiation\r\n\r\n          4. Patients with multifocal tumor, primarily infratentorial or posterior fossa tumor, or\r\n             leptomeningeal dissemination of tumor.\r\n\r\n          5. Patient with any other active malignancy besides GBM, excluding non-melanomatous skin\r\n             cancer, or carcinoma in situ of the cervix, prostate, or breast, unless patient has\r\n             been disease-free/in remission for >=2 years prior to date of study enrollment\r\n\r\n          6. Patients known to be HIV-positive. HIV testing is not required for study\r\n             participation.\r\n\r\n          7. Uncontrolled concurrent illness including psychiatric illness, or situations that\r\n             would limit compliance with the study requirements or the ability to willingly give\r\n             written informed consent.\r\n      ","sponsor":"Jennifer Clarke","sponsor_type":"Other","conditions":"Recurrent Glioblastoma","interventions":[{"intervention_type":"Drug","name":"Drug: Individualized therapy","description":"For a given proposed individualized combination of drugs the first priority to establish doses will be to identify the same combination of drugs in a peer-reviewed journal article or presented as a reviewed abstract.\r\nWhen a proposed individualized combination of drugs has not previously been reported, the process to establish doses will be to then identify individual members of the proposed combination that have been used in combination with other cytotoxic agents similar to those being considered for combination therapy.\r\nWhen a proposed individualized combination of drugs has no available combination data, dosing guidelines will start with the FDA-approved package insert recommended dose."}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of patients who have successfully initiated therapy","time_frame":"Up to 35 days after surgery","description":"Feasibility of implementing a truly personalized tumor treatment drug regimen for patients with surgically resectable recurrent glioblastoma is defined as the percentage of patients who have successfully initiated therapy based on their individualized treatment regimen within 35 days following surgical resection of recurrent tumor."},{"outcome_type":"secondary","measure":"Incidence of treatment-related Adverse Events (AEs)","time_frame":"Up to 1 year","description":"Incidence of treatment-related AEs, grades 3-5 using NCI CTCAE v5.0 either due to individual treatment or combination treatment regimen"},{"outcome_type":"secondary","measure":"Progression-Free Survival (PFS) at 6 months","time_frame":"6 months","description":"PFS at 6 months is defined as the percentage of participants who have neither progressed nor died within 6 months after the first dose of individual treatment or combination treatment regimen. PFS at 6 months will be assessed by (modified) Response assessment in neuro-oncology criteria (RANO) and estimated using Kaplan Meier method."},{"outcome_type":"secondary","measure":"Progression-Free Survival (PFS)","time_frame":"Up to 5 years.","description":"PFS period is defined as the number of days from start of individual treatment or combination treatment regimen to disease progression or death. The PFS days of patient groups will be estimated using Kaplan-Meier method to show median progression-free period (days when 50% patients remain progression-free)."},{"outcome_type":"secondary","measure":"Overall survival (OS)","time_frame":"Up to 5 years","description":"Overall survival is defined as the length of time from start of individual treatment or combination treatment regimen until date of death. For the participants who were alive at the end of study or lost to follow-up, overall survival will be censored on the last date when participants were known to be alive. OS will be estimated using the Kaplan-Meier method."}]}
{"nct_id":"NCT03798496","start_date":"2018-12-18","enrollment":20,"brief_title":"Anatomical and Biomechanical Study About Stability in Galeazzis Fracture","official_title":"Role of the Interosseous Membrane and TFCC in DRUJ Stability in Galeazzis Fracture: Anatomical and Biomechanical Study","primary_completion_date":"2021-01-31","study_type":"Observational [Patient Registry]","rec_status":"Completed","completion_date":"2021-01-31","last_update":"2021-07-13","description":"Most Galeazzi fractures can be treated adequately with open reduction and internal fixation (ORIF) of the radius alone, but some will remain unstable at the DRUJ and require repair of the TFCC.The purpose of this anatomical and biomechanical study was to define and measure DRUJ dislocation, displacement and instability associated with the sequential sectioning of the different bands in the interosseous membrane (IOM) and TFCC in the simulation of a Galeazzi fracture.","other_id":"IIBSP-GAL-2018-75","observational_model":"Cohort","time_perspective":"Other","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":85,"population":"Anatomical and biomechanical study: Twelve specimens from the Human Anatomy Department.\r\n\r\n        Clinical study: Review of reports (X-rays) about patients with Galeazzi\r\n        fracture-dislocation treated with ORIF.","criteria":"\n        Inclusion Criteria:\r\n\r\n        Adults patients(18-85 years old) with Galeazzi fracture-dislocation treated with open\r\n        reduction and internal fixation (ORIF).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Children\r\n\r\n          -  Other types of forearms fractures\r\n      ","sponsor":"Fundaci Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau","sponsor_type":"Other","conditions":"Galeazzi's Fracture","interventions":[{"intervention_type":"Procedure","name":"Procedure: Open reduction and internal fixation","description":"Open reduction of the Galeazzi fracture dislocation with a plate."}],"outcomes":[{"outcome_type":"primary","measure":"Displacement in distal radius fracture","time_frame":"12 months","description":"The investigators will mesure the degree of displacement (mm) in a simulate distal radius fracture with a biomechanical device named Medmesin with a especific computer software that applies newtons (from 0 to 100N) in the radius in each especimen."},{"outcome_type":"primary","measure":"Stability in the DRU joint","time_frame":"12 months","description":"Dislocation of the ulnar in the wrist. In the retrospective clinical reports the investigators evaluate the x-rays before and after the surgery and the radioulnar ratio in the CT scan (congruency method, Mino criteria and the epicenter method)."}]}
{"nct_id":"NCT03760419","start_date":"2018-12-17","phase":"N/A","enrollment":2000,"brief_title":"Improving CarE for Community Acquired Pneumonia","official_title":"Improving CarE for Community Acquired Pneumonia (ICE-CAP)","primary_completion_date":"2022-07-01","study_type":"Interventional","rec_status":"Enrolling by invitation","completion_date":"2022-07-01","last_update":"2021-03-30","description":"Children with pneumonia presenting to the emergency department at Monroe Carell Jr. Children's Hospital at Vanderbilt or Primary Children's Hospital at the University of Utah will be potentially eligible for study. During intervention periods, providers caring for enrolled children will be presented with a detailed decision support strategy that emphasizes management in accordance with national guideline recommendations. The anticipated study duration is 18 months for Aim 1 and 24 months for Aim 2. As this study does not include direct contact with enrolled subjects, there is no anticipated follow up.","other_id":"R01AI125642","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Health Services Research","masking_description":"Double","intervention_model_description":"Aim 1: Effectiveness of the EHR-based antibiotic decision support application for promoting guideline-concordant antibiotic prescribing in children presenting for emergency care will be evaluated in a pragmatic, cluster randomized crossover study conducted over a period of 18 months that includes two respiratory seasons. Crossover will occur each month in a randomly determined sequence within each hospital. To ensure balanced representation of each arm in periods of both low and high pneumonia prevalence, randomization will occur in 3 permuted blocks (size=6).\r\nAim 2: The investigator will conduct a randomized controlled trial comparing our prognostic tool (intervention arm) to usual care (control arm) over a period of 24 months. Randomization will occur at the patient level. Allocation to intervention or control will be based on medical record number (even vs. odd) and will be assigned automatically once a provider confirms the diagnosis of pneumonia via the radiology alert tool.","sampling_method":"","gender":"All","minimum_age":0.5,"maximum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Six months to <18 years of age\r\n\r\n          -  Radiographic evidence of pneumonia in ED (via natural language processing)\r\n\r\n          -  Provider-confirmed diagnosis of pneumonia (via Clinical Decision Support (CDS))\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Children with tracheostomy, cystic fibrosis, immunosuppression\r\n\r\n          -  Inter-hospital transfers\r\n\r\n          -  Hospitalization within preceding 7 days\r\n\r\n          -  Previously enrolled within preceding 28 days\r\n\r\n          -  Provider preference for any reason\r\n      ","sponsor":"Vanderbilt University Medical Center","sponsor_type":"Other","conditions":"Pneumonia Childhood","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Decision Support","description":"For enrolled subjects assigned to the decision support arm, providers will receive antibiotic recommendations in accordance with the 2011 PIDS/IDSA guideline, tailored to site of care and illness severity. The tool will offer treatment recommendations only and will not proscribe a specific treatment plan. Providers will receive prognostic information derived from the previously validated and best performing model. The application will calculate predicted risk for moderate (intensive care) and severe (respiratory failure or shock) outcomes using the parameters derived from the prognostic tool's regression equation. The tool will offer prognostic information only and will not proscribe a specific site of care or management plan."}],"outcomes":[{"outcome_type":"primary","measure":"Guideline-Concordant Antibiotic Therapy (Aim 1)","time_frame":"18 months","description":"The primary outcome for Aim 1 is the proportion of children exclusively receiving guideline-concordant first line antibiotic therapy during the first 24 hours of care. Aim 1 will last 18 months."},{"outcome_type":"primary","measure":"Appropriate Site of Care Disposition (Aim 2)","time_frame":"24 months","description":"The primary outcome for Aim 2 is appropriate site of care disposition. Surveillance for subsequent emergency department visits and hospitalizations to the institutions, as well as escalation to higher levels of care, will be captured. Aim 2 will last 24 months."},{"outcome_type":"secondary","measure":"Concordant Antibiotic Use (Aim 1)","time_frame":"18 months","description":"Secondary outcomes for Aim 1 include exclusive use of concordant antibiotic therapy for the entire episode, any use of concordant antibiotic therapy during the first 24 hours of care and for the entire episode. Aim 1 will last 18 months."},{"outcome_type":"secondary","measure":"Emergency Department Revisits and Hospitalizations (Aim 1)","time_frame":"18 months","description":"Secondary outcomes for Aim 1 include emergency department revisits and hospitalizations within 72 hours and 7 days of the index discharge. Aim 1 will last 18 months."},{"outcome_type":"secondary","measure":"Overall Site of Care Disposition (Aim 2)","time_frame":"24 months","description":"Secondary outcomes for Aim 2 include the overall site of care disposition (emergency department discharge, ward, intensive care unit)."},{"outcome_type":"secondary","measure":"Emergency Department Revisits and Hospitalizations (Aim 2)","time_frame":"24 months","description":"Secondary outcomes for Aim 2 include emergency department revisits and hospitalizations within 72 hours and 7 days of the index discharge. Aim 2 will last 24 months."}]}
{"nct_id":"NCT04067089","start_date":"2018-12-10","phase":"N/A","enrollment":126,"brief_title":"Treatment of Aortic Stenosis in Brazil: Cost-Utility Analysis of TAVI vs SAVR","official_title":"Prospective, Randomized, Cost-utility Analysis of Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in Brazil","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-12-31","last_update":"2021-07-19","description":"TEAM-Br is a randomized, prospective, cost-utility study comparing transcatheter aortic valve implantation (TAVI) versus surgical aortic vale replacement in Brazil. The study is sponsored by the national Minister of Health, through PROADI-SUS (Programa de Apoio ao Desenvolvimento Institucional do SUS).","other_id":"TEAm-BR","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Randomized controlled trial","sampling_method":"","gender":"All","minimum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age > 70 years;\r\n\r\n          -  Symptoms of heart failure NYHA class > II;\r\n\r\n          -  Severe aortic stenosis (as defined by echocardiography: mean gradient >40 mmHg or jet\r\n             velocity greater than 4.0 m/s or an initial aortic valve area of < 1.0 cm2)\r\n\r\n          -  Heart team (including examining cardiac surgeon) agree on eligibility including\r\n             assessment that TAVR or SAVR is appropriate;\r\n\r\n          -  The study patient or the study patient's legal representative informed of the nature\r\n             of the study, agreed to its provisions and provided written informed consent as\r\n             approved by the Institutional Review Board (IRB) center;\r\n\r\n          -  The study patient agreed to comply with all required post-procedure follow-up visits\r\n             including visits through 1 month and 1 year;\r\n\r\n          -  Heart team agreed (a priori) on treatment strategy for concomitant coronary disease\r\n             (if present);\r\n\r\n          -  Patient agreed to undergo surgical aortic valve replacement (SAVR) if randomized to\r\n             control treatment.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Heart Team assessment of inoperability (including examining cardiac surgeon);\r\n\r\n          -  Hostile chest\r\n\r\n          -  Evidence of an acute myocardial infarction  1 month (30 days) before the intended\r\n             treatment [defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB \r\n             twice normal in the presence of MB elevation and/or troponin level elevation (WHO\r\n             definition)];\r\n\r\n          -  Concomitant severe valvular disease (mitral, tricuspid or pulmonic) requiring surgical\r\n             intervention;\r\n\r\n          -  Preexisting mechanical or bioprosthetic aortic valve with dysfunction;\r\n\r\n          -  Complex coronary artery disease: unprotected left main coronary artery, Syntax score >\r\n             32 (in the absence of prior revascularization);\r\n\r\n          -  Any therapeutic invasive cardiac procedure resulting in a permanent implant that is\r\n             performed within 30 days of the index procedure (unless part of planned strategy for\r\n             treatment of concomitant coronary artery disease). Implantation of a permanent\r\n             pacemaker is not an exclusion criteria;\r\n\r\n          -  Leukopenia (WBC < 3000 cell/mL), acute anemia (Hgb < 9 g/dL), thrombocytopenia (Plt <\r\n             50,000 cell/mL);\r\n\r\n          -  Hypertrophic cardiomyopathy with or without obstruction (HOCM);\r\n\r\n          -  Severe ventricular dysfunction with LVEF < 20%;\r\n\r\n          -  Echocardiographic evidence of intracardiac mass, thrombus or vegetation;\r\n\r\n          -  Active upper GI bleeding within 3 months (90 days) prior to procedure;\r\n\r\n          -  A known contraindication or hypersensitivity to all anticoagulation regimens, or\r\n             inability to be anticoagulated for the study procedure;\r\n\r\n          -  Clinically (by neurologist) or neuroimaging confirmed stroke or transient ischemic\r\n             attack (TIA) within 6 months (180 days) of the procedure;\r\n\r\n          -  Renal insufficiency (creatinine > 3.0 mg/dL) and/or renal replacement therapy at the\r\n             time of screening;\r\n\r\n          -  Estimated life expectancy < 24 months (730 days) due to carcinomas, chronic liver\r\n             disease, chronic renal disease or chronic end stage pulmonary disease;\r\n\r\n          -  Currently participating in an investigational drug or another device study;\r\n\r\n          -  Active bacterial endocarditis within 6 months (180 days) of procedure;\r\n\r\n          -  Patient refuses surgery for aortic valve replacement.\r\n      ","sponsor":"Hospital do Coracao","sponsor_type":"Other","conditions":"Aortic Stenosis","interventions":[{"intervention_type":"Procedure","name":"Procedure: TAVR - Transcatheter aortic valve replacement","description":"TAVR - Transcatheter aortic valve replacement with Acurate Neo bioprosthesis (Boston Scientific) using minimalist approach"},{"intervention_type":"Procedure","name":"Procedure: Surgical aortic valve replacement","description":"Surgical aortic valve replacement"}],"outcomes":[{"outcome_type":"primary","measure":"Cost-utility of minimalist TAVR as compared to SAVR","time_frame":"1 year","description":"Quality-adjusted life-years (QALYs). Quality of life will be assessed by EuroQol 5D."},{"outcome_type":"primary","measure":"Cost-utility of minimalist TAVR as compared to SAVR","time_frame":"1 year","description":"Incremental cost-effectiveness ratio (ICER)"},{"outcome_type":"secondary","measure":"Clinical outcomes","time_frame":"30 days and 1 year","description":"All-cause mortality, cardiovascular mortality, disabling stroke, acute renal failure, bleeding, major vascular complications, atrial fibrillation and permanent pacemaker implantation"}]}
{"nct_id":"NCT03740477","start_date":"2018-12-03","phase":"N/A","enrollment":1019,"brief_title":"Screening for Atrial Fibrillation in Native AmeRicans Using iPhone ECG","official_title":"Screening for Atrial Fibrillation in Native AmeRicans Using iPhone ECG (SAFARI)","primary_completion_date":"2020-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-10-31","last_update":"2021-04-23","description":"Atrial fibrillation (AF) is the most common clinically significant arrhythmia and is associated with increased rates of stroke, heart failure, mortality, hospitalization, and cognitive decline. Approximately one third of ischemic strokes are attributable to either previously known or newly detected AF at the time of stroke. Many AF episodes are asymptomatic and stroke is the first manifestation of AF in at least 25% of AF-related strokes. Anticoagulation for AF leads to a reduction in stroke to levels similar to matched individuals without AF. Therefore, identifying AF in an earlier asymptomatic state (i.e. screening for silent AF), with subsequent initiation of anticoagulation in at-risk individuals, may decrease the risk of future thromboembolic events. The availability of inexpensive smartphone-based or handheld ECG devices that rapidly acquire a cardiac rhythm strip of quality comparable to a traditional 12-lead ECG have markedly enhanced the feasibility of AF screening. Native Americans have a high prevalence of diabetes and higher incidence of stroke than whites and blacks. Our central hypothesis is that screening for AF using a single time point, 30-second iPhone-based ECG recording over 2 weeks will result in identification of silent AF in a significant number of individuals at risk for stroke compared to routine care (no screening) and will thus lead to improved outcomes through initiation of anticoagulation. The aim of this study is to screen for AF in Native Americans who are seen at the Absentee Shawnee Tribal clinic using a smartphone-based ECG device. Individuals who are at least 50 years old and have no prior history of AF will be eligible for enrollment in the study. Eligible participants will receive a 30-second ECG recording during their visit at the Absentee Shawnee Tribal clinic. The device has an algorithm for diagnosis of AF, which is 98% sensitive and 97% specific. A cardiologist will overread the tracings that are diagnosed by AF by the device. Those confirmed to have AF will be referred to a cardiologist for further evaluation and management. The clinical characteristics of those who are found to have AF will be compared with those who are not, in order to identify risk factors for AF. Newly diagnosed AF using this method is expected to be approximately 2.5%. We aim to include a total of 1,500 participants over 12 months. The proposed study will provide the basis for the design of further intervention studies using mobile technology to improve the health of Native Americans and other minority populations. In light of the high prevalence of risk factors for AF in Native Americans and the association of silent AF with stroke, this novel approach for AF screening has the potential to impact clinical practice and improve health outcomes among a large number of individuals.","other_id":"9501","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":50,"maximum_age":100,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female aged 50 or older\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Known history of atrial fibrillation\r\n      ","sponsor":"University of Oklahoma","sponsor_type":"Other","conditions":"Atrial Fibrillation","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: ECG","description":"Eligible participants will receive a 30-second ECG recording during their visit at the Absentee Shawnee Tribal clinic"}],"outcomes":[{"outcome_type":"primary","measure":"incidence of newly diagnosed atrial fibrillation","time_frame":"12 months"},{"outcome_type":"secondary","measure":"prevalence of guideline-directed anticoagulant use among participants who are found to have atrial fibrillation","time_frame":"12 months"}]}
{"nct_id":"NCT03782922","start_date":"2018-12-01","phase":"N/A","enrollment":80,"brief_title":"Exercise Training Programm for Physiotherapy Students","official_title":"Effect of an Exercise Training Programm on Mental and Anatomical Characteristics of Physiotherapy Students - a Randomized Controlled Trial","primary_completion_date":"2019-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-03-31","last_update":"2019-04-11","description":"In this study, i.e. randomized controlled trial, the effect of an exercise training program on mental and anatomical characteristics of physiotherapy students is measured.","other_id":"2018-01954","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  age 18\r\n\r\n          -  signed consent\r\n\r\n          -  THIM student\r\n\r\n          -  good health status\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  alcohol\r\n\r\n          -  drugs\r\n\r\n          -  smoking\r\n      ","sponsor":"THIM - die internationale Hochschule fr Physiotherapie","sponsor_type":"Other","conditions":"Student|Healthy|Physical Therapy","interventions":[{"intervention_type":"Other","name":"Other: Exercise Training Program","description":"10min of coordination and strength training (2-3x per week) during 2-6 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"d2-R-Test","time_frame":"Change from baseline attention and concentration at 4 weeks (objective)","description":"Mental"},{"outcome_type":"primary","measure":"AKA-Questionnaire (attention, concentration, learning ability)","time_frame":"Change from baseline attention and concentration at 4 weeks (subjective)","description":"Participants fill out a questionnaire about attention, concentration and learning ability. There are five possible answers for each item from 1 (completely disagree) to 5 (completely agree)."},{"outcome_type":"primary","measure":"M360 - physiological parameter of the spine","time_frame":"Change from baseline position and mobility of the spine at 4 weeks","description":"Participants are measured in different positions (upright, flexion, extension; measured in degrees) to assess position, stability and mobility of the spine. The M360 will be guided along the back and the data will be collected electronically (https://www.idiag.ch/idiag-m360/)."},{"outcome_type":"primary","measure":"Pain (Visual Analogue Scale)","time_frame":"Change from baseline pain (back) at 4 weeks","description":"Participants can use this scale to classify their pain from \"No pain\" and \"Maximum pain imaginable\" by means of a slider."},{"outcome_type":"primary","measure":"FAW-Questionnaire (Actual physical well-being)","time_frame":"Change from baseline physical well-being at 4 weeks","description":"Participants fill out a questionnaire with 58 questions. Each question has five possible answers from 0 (completely disagree) to 4 (completely agree). The highter the score the better the actual physical well-being."}]}
{"nct_id":"NCT03187171","start_date":"2018-12-01","phase":"N/A","enrollment":0,"brief_title":"ACDF Comparison Trial","official_title":"Comparison of Outcomes After ACDF Using Allograft Fusion Versus PEEK Fusion: a Prospective Clinical Trial","primary_completion_date":"2019-04-23","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2019-04-23","last_update":"2019-05-13","description":"This research protocol seeks to compare radiological and clinical outcomes of cervical spine disease patients following standard-of-care anterior cervical discectomy and fusion (ACDF) using allograft fusion versus Cohere porous polyetheretherketone (PEEK) fusion device. This clinical study presents little to no additional risk to study subjects beyond those associated with standard-of-care ACDF surgery. Adults age 18 and over who are undergoing an ACDF procedure will be enrolled in the study. The study consists of a completing a series of questionnaires and obtaining radiographs. The primary endpoint of the study will be the rate of successful spinal fusion for each group. For evaluation of the primary endpoint and additional assessments, descriptive statistics including mean, standard deviation, minimum, median, and maximum for continuous variables and frequency distribution for categorical variables will be provided, as well as tabular listings. All complications will be itemized including incidence, duration, and relationship to the device used and/or procedures performed.","other_id":"Pro00083342","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"This is a prospective randomized comparative outcomes study, in which all subjects who fit the inclusion and exclusion criteria and who agreed to be part of the study will be randomized to either Allograft or Cohere PEEK fusion group and will be followed for approximately 12 months following surgery according to the standard-of-care.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":99,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. 18 or more years of age\r\n\r\n          2. Able to provide informed consent\r\n\r\n          3. Has documented diagnosis of cervical spine radiculopathy and/or myelopathy\r\n\r\n          4. Is undergoing standard-of-care ACDF\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Prior cervical spine surgery\r\n\r\n          2. Single-level ACDF\r\n\r\n          3. Has a systemic infection or cervical spine infection\r\n\r\n          4. Has a medical condition that may interfere with bone and soft tissue healing\r\n\r\n          5. Any condition that, in the opinion of the investigator, may preclude accurate data\r\n             collection or evaluation.\r\n      ","sponsor":"Duke University","sponsor_type":"Other","conditions":"Cervical Spine Disc Disease|Surgery|Fusion of Spine|Degenerative Disc Disease","interventions":[{"intervention_type":"Other","name":"Other: Allograft Fusion","description":"ACDF is a surgical technique used to treat a variety of cervical spine disorders, such as nerve root or spinal cord compression, cervical spondylosis, and cervical spinal stenosis. The anterior approach to the cervical spine for discectomy and fusion by the insertion of an autologous iliac crest tricortical bone graft was first described by Robinson and Smith in 1955. In 1958, Cloward described a wide anterior cylindrical discectomy performed with a special reamer combined with anterior fusion by the insertion of autologous iliac bone graft of the same shape. At Duke University Health Systems, both allografts and Cohere porous PEEK fusion device are used for ACDF."},{"intervention_type":"Device","name":"Device: Cohere PEEK Fusion Group","description":"Bagby et al. developed the first interbody fusion cage. Cages of different shapes and materials are used to perform ACDF which, in some cases, could be associated with plate fixation. At Duke University Health Systems, both allografts and Cohere porous PEEK fusion device are used for ACDF."}],"outcomes":[{"outcome_type":"primary","measure":"Rate of successful fusion.","time_frame":"18 months","description":"To compare post-operative bone fusion following standard-of-care ACDF using allograft fusion or Cohere porous PEEK fusion."},{"outcome_type":"secondary","measure":"Overall success rate - composite score.","time_frame":"18 months","description":"To be considered an overall success, patients have to achieve all of the following: a ≥15 point improvement in their NDI scores, maintenance or improvement in their neurologic status, no serious adverse events related to the implant or surgical procedure, and no subsequent surgery or intervention that is classified as \"failure.\""}]}
{"nct_id":"NCT02983266","start_date":"2018-12-01","phase":"N/A","enrollment":0,"brief_title":"Vagal Nerve Stimulation to Reduce Inflammation and Hyperadrenergia","official_title":"A Study of Safety and Autonomic Responses to Non-Invasive Vagal Stimulation in Persons With Spinal Cord Injury and Non-Disabled Controls Both With and Without Inflammatory Stress","primary_completion_date":"2020-12-01","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2020-12-01","last_update":"2018-10-09","description":"The purpose of this research device study is to learn more about the autonomic nervous system. This system uses nerves to send information from the brain to the rest of the body by electrical signaling and has two divisions, the sympathetic and the parasympathetic branches. It has been thought that electrical stimulation devices could be used to restore balance to the nervous system. Because most of the imbalance seems to happen due to too much sympathetic activity, the investigator plans to focus on the parasympathetic branch. Specifically, the investigator hopes to restore balance by targeting the vagus nerve, which is the main communicator of the parasympathetic branch. The study will examine whether the investigator can decrease sympathetic activity and chronic inflammation by increasing parasympathetic activity. This is a device study that will examine the use of non-invasive vagal nerve stimulation to attenuate inflammatory stress and sympathetic hyperactivity in persons with Spinal Cord Injury and Non-Disabled Controls.","other_id":"20150478","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Group 1 & 2:\r\n\r\n        Inclusion Criteria:\r\n\r\n          1. Age 18-65\r\n\r\n          2. Willingness to participate in the study\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Use of an active electrical implant, such as a cardiac pacemaker or cochlear implant\r\n\r\n          2. Use of a hearing aid in the left ear\r\n\r\n          3. Use of an implanted insulin or morphine (pain) pump\r\n\r\n          4. Self-reported history of syncope from known or unknown origins\r\n\r\n          5. Self-reported history of cardiovascular disease or dysfunction (e.g., cardiovascular\r\n             disease, arrhythmia, congestive heart failure, or stroke)\r\n\r\n        Group 3:\r\n\r\n        Inclusion Criteria:\r\n\r\n          1. Age 18-65\r\n\r\n          2. Overweight, with a BMI  27\r\n\r\n          3. Presence of chronic inflammation, with C-reactive protein values > 3 mg/l\r\n\r\n          4. Willingness to participate in the study\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Use of an active electrical implant, such as a cardiac pacemaker or cochlear implant\r\n\r\n          2. Use of a hearing aid in the left ear\r\n\r\n          3. Use of an implanted insulin or morphine (pain) pump\r\n\r\n          4. Self-reported history of syncope from known or unknown origins\r\n\r\n          5. Self-reported history of cardiovascular disease or dysfunction (e.g., cardiovascular\r\n             disease, arrhythmia, congestive heart failure, or stroke)\r\n\r\n          6. Use of statin drugs\r\n\r\n        Group 4:\r\n\r\n        Inclusion Criteria:\r\n\r\n          1. Age 18-65\r\n\r\n          2.  1-year post-injury\r\n\r\n          3. Bladder management by clean intermittent catheterization\r\n\r\n          4. Spinal cord injury resulting in Paraplegia level T1 to T6 and motor-complete (AIS A or\r\n             B) impairment. Injury level and impairment will be confirmed by an ASIA exam conducted\r\n             less than 2 years before study entry. If longer than 2 years, we will have a certified\r\n             rater repeat the exam.\r\n\r\n          5. Participant report of symptoms related to autonomic dysreflexia during episodes of\r\n             full bladder or voiding, including elevated BP, mild headache, paresthesia, chills,\r\n             nasal congestion, flushing of the skin, or diaphoresis.\r\n\r\n          6. Willingness to participate in the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Currently hospitalized\r\n\r\n          2. American Spinal Injury Association (AIS) C-E\r\n\r\n          3. Currently using an insulin, morphine (pain), or intrathecal pump\r\n\r\n          4. Use of an active electrical implant, such as a cardiac pacemaker or cochlear implant\r\n\r\n          5. Use of a hearing aid in the left ear\r\n\r\n          6. Self-reported history of syncope from known or unknown origins\r\n\r\n          7. Self-reported history of cardiovascular disease or dysfunction (e.g., cardiovascular\r\n             disease, arrhythmia, congestive heart failure, or stroke)\r\n      ","sponsor":"University of Miami","sponsor_type":"Other","conditions":"Spinal Cord Injury","interventions":[{"intervention_type":"Device","name":"Device: InTENsity MicroCombo","description":"An electrotherapy device."}],"outcomes":[{"outcome_type":"primary","measure":"Change in parasympathetic activity after vagal nerve stimulation by Heart Rate Variability","time_frame":"Baseline to 90 minutes post-vagal nerve stimulation","description":"Measured by the normal-to-normal QRS complexes of the PQRST waveform of the electrocardiogram (ECG)"},{"outcome_type":"secondary","measure":"Group 1 & 4: Change in acute heart rate response to vagal nerve stimulation","time_frame":"Baseline to 90 minutes post-vagal nerve stimulation","description":"Measured by numerical heart rate in beats per minute"},{"outcome_type":"secondary","measure":"Group 1 & 4: Change in acute blood pressure response to vagal nerve stimulation","time_frame":"Baseline to 90 minutes post-vagal nerve stimulation","description":"Measured by diastolic and systolic blood pressure (mm/Hg)"},{"outcome_type":"secondary","measure":"Group 1: Change in parasympathetic activity after vagal nerve stimulation by Vagus Somatosensory Evoked Potentials","time_frame":"Baseline to 90 minutes post-vagal nerve stimulation","description":"Measured by far field potentials from the brain stem"},{"outcome_type":"secondary","measure":"Group 2 & 4: Change in acute physiological stress response by a change in peripheral cortisol","time_frame":"Baseline to 90 minutes post-experimental stimulus","description":"Measured by cortisol levels in plasma"},{"outcome_type":"secondary","measure":"Group 2 & 4: Change in acute physiological stress response by a change in peripheral catecholamines","time_frame":"Baseline to 90 minutes post-experimental stimulus","description":"Measured by catecholamine levels in plasma"},{"outcome_type":"secondary","measure":"Group 2 & 4: Change in acute physiological stress response by a change in heart rate","time_frame":"Baseline to 90 minutes post-experimental stimulus","description":"Measured by numerical heart rate in beats per minute"},{"outcome_type":"secondary","measure":"Group 2 & 4: Change in acute physiological stress response by a change in blood pressure","time_frame":"Baseline to 90 minutes post-experimental stimulus","description":"Measured by diastolic and systolic blood pressure (mm/Hg)"},{"outcome_type":"secondary","measure":"Group 3 & 4: Change in inflammatory biomarkers after vagal nerve stimulation","time_frame":"Baseline to 90 minutes post-vagal nerve stimulation","description":"Measured by cytokine levels in plasma"}]}
{"nct_id":"NCT03786250","start_date":"2018-12-01","enrollment":450,"brief_title":"Comprehensive Geriatric Assessment in an Emergency Department","official_title":"Comprehensive Geriatric Assessment in Emergency Department. Impact on Health and Patient Flows","primary_completion_date":"2018-12-01","study_type":"Observational","rec_status":"Unknown status","completion_date":"2019-12-01","last_update":"2018-12-26","description":"Purpose Frailty and multi-morbidity have been associated with increased pressure on Emergency Departments (ED), higher hospital admissions and more risks for patients arising from the ED stay. The advantages of developing specific attention to frailty in ED have been highlighted. The benefits of these approaches are related to patients but also to organizations. The aim is to present how a Program of Care for Frailty (PCF) in an ED impacts on patient health and flows. Objective is to analyze the clinical impact of Comprehensive Geriatric Care (CGA) in the Emergency Department (ED) and on patient flows Setting: A tertiary, teaching, 550-bed urban hospital, with 80,000 adult patients/year ED attendances (43%65 years). Two periods are compared: First period (before CGA implantation) del 01/04/2016 - 15/04/2016 and second period (after) 01/04/2017 - 15/04/2017","other_id":"IIBSP-AGI-2017-14","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":115,"population":"All patients older than 65 years, attended in ED during the study periode.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  All patients older than 65 years attended in the ED\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  None\r\n      ","sponsor":"Fundaci Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau","sponsor_type":"Other","conditions":"Emergencies|Aging|Geriatric Assessment|Patient Discharge","interventions":[{"intervention_type":"Procedure","name":"Procedure: Geriatric Assessment","description":"Systematic screening of delirium, prevention of delirium, early treatment, pain management with scales adapted to chronicity, conciliation of medication to emergency discharge, among others."}],"outcomes":[{"outcome_type":"primary","measure":"Number of patients with delirium","time_frame":"From date of admission until discharge, assessed up to 30 days"},{"outcome_type":"secondary","measure":"Number of patients with pain correctly treated","time_frame":"From date of admission until discharge, assessed up to 30 days"}]}
{"nct_id":"NCT03768791","start_date":"2018-12-01","phase":"N/A","enrollment":23,"brief_title":"HRV in Patients Treated With Spinal Cord Stimulation","official_title":"Heart Rate Variability in Patients With Failed Back Surgery Syndrome, Treated With Spinal Cord Stimulation","primary_completion_date":"2018-12-21","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-12-21","last_update":"2019-06-18","description":"This study is an observatory single center study investigating heart rate variability during on and off states of the spinal cord stimulator, in patients with failed back surgery syndrome.","other_id":"SYNCHRO","allocation":"Non-Randomized","intervention_model":"Sequential Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subject is at least 18 years old.\r\n\r\n          -  Diagnosis of FBSS (Failed conservative treatments for pain including but not limited\r\n             to pharmacological therapy and physical therapy) and currently being treated with\r\n             spinal cord stimulation.\r\n\r\n          -  Cognitive and language functioning enabling coherent communication between the\r\n             examiner and the participant.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  The presence of one or more coexisting conditions known to affect HRV analysis\r\n             (including but not limited to atrial fibrillation, numerous atrial or ventricular\r\n             extra beats, paced rhythm, left ventricular bundle branch block, cancer, kidney or\r\n             hepatic failure, and diabetes mellitus (autonomic nervous system dysfunction)).\r\n\r\n          -  The use of medication that directly modifies autonomic control (for example\r\n             beta-blockers).\r\n      ","sponsor":"Moens Maarten","sponsor_type":"Other","conditions":"Failed Back Surgery Syndrome","interventions":[{"intervention_type":"Other","name":"Other: SCS is switched off","description":"Spinal cord stimulator is switched off for 12 hours"},{"intervention_type":"Other","name":"Other: SCS is switched on","description":"Spinal cord stimulator is on"}],"outcomes":[{"outcome_type":"primary","measure":"Heart rate variability changes","time_frame":"Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day.","description":"The investigators will examine the difference in heart rate variability between both measurements (SCS on versus SCS off)"},{"outcome_type":"secondary","measure":"Pain intensity scores","time_frame":"Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day.","description":"Pain intensity scores on a visual analogue scale ranging from zero (no pain) towards 10 (worst possible pain)."}]}
{"nct_id":"NCT03699449","start_date":"2018-11-26","phase":"Phase 2","enrollment":104,"brief_title":"An uMbrella Study of BIomarker-driven Targeted Therapy In Patients With Platinum-resistant Recurrent OvariaN Cancer(AMBITION)","official_title":"An uMbrella Study of BIomarker-driven Targeted Therapy In Patients With Platinum-resistant Recurrent OvariaN Cancer(AMBITION)","primary_completion_date":"2022-09-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-09-30","last_update":"2021-04-01","description":"This study is a pilot study of biomarker-driven targeted therapy in patients with platinum-resistant recurrent ovarian cancer. More specifically, this is a randomized, multi-center, open label, phase II study for Homologous Recombination Deficiency(HRD)+ patients and a biomarker-driven multiple-arm phase II study for Homologous Recombination Deficiency(HRD)- patients. This study will consist of a number of study modules (substudies), each evaluating the antitumor activity of targeted agents in patients whose tumors express specific phenotype relevant to the molecules under investigation.","other_id":"4-2018-0749","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"This is a randomized, multi-center, open label, phase II study for HRD+ patients and a biomarker-driven multiple-arm phase II study for HRD- patients.\r\nThis study will consist of a number of study modules (substudies), each evaluating the antitumor activity of targeted agents in patients whose tumors express specific phenotype relevant to the molecules under investigation.","sampling_method":"","gender":"Female","minimum_age":20,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically confirmed high-grade serous or high-grade endometrioid ovarian, primary\r\n             peritoneal, or fallopian tube cancers.\r\n\r\n          -  Disease progression within 6 months of completing platinum-based chemotherapy\r\n\r\n          -  Who had received  two lines of chemotherapy\r\n\r\n          -  Provision of informed consent prior to any study specific procedures\r\n\r\n          -  Female aged 20 years older at time of study entry\r\n\r\n          -  Body weight >30kg\r\n\r\n          -  Patients must have normal organ and bone marrow function measured within 28 days prior\r\n             to administration of study treatment as defined below: 1) Haemoglobin  10.0 g/dL with\r\n             no blood transfusion in the past 28 days, 2) Absolute neutrophil count (ANC)  1.5 x\r\n             109/L, 3) Platelet count  100 x 109/L, 4) Total bilirubin  1.5 x institutional upper\r\n             limit of normal (ULN), 5) Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic\r\n             Transaminase (SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate\r\n             Transaminase (SGPT))  3 x institutional upper limit of normal unless liver metastases\r\n             are present in which case they must be  5x ULN, 6) Patients must have creatinine\r\n             clearance estimated using the Cockcroft-Gault equation of 50 mL/min: Estimated\r\n             creatinine clearance = (140-age [years]) x weight (kg) (x F)a serum creatinine (mg/dL)\r\n             x 72, 7) a where F=0.85 for females and F=1 for males, 8) Urine protein: creatinine\r\n             ratio (UPC) 1 OR 2+ proteinuria on two consecutive dipsticks taken no less than 1\r\n             week apart. Patients with 2+ proteinuria on dipstick must also have UPC <0.5 on 2\r\n             consecutive samples. 9) Adequately controlled blood pressure (systolic blood pressure\r\n             (SBP) 140 mmHg; diastolic blood pressure (DBP)  90mmHg) on maximum of 3\r\n             antihypertensive medications. Patients must have a blood pressure (BP) of  140/90\r\n             mmHg taken in the clinic setting by a medical professional within 2 weeks prior to\r\n             starting study. It is strongly recommended that patients who are on three\r\n             antihypertensive medications be followed by a cardiologist or a primary care physician\r\n             for management of BP while on study. 10) Adequately controlled thyroid function, with\r\n             no symptoms of thyroid dysfunction\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1\r\n\r\n          -  Patients must have a life expectancy  16 weeks.\r\n\r\n          -  Postmenopausal or evidence of non-childbearing status for women of childbearing\r\n             potential: negative urine or serum pregnancy test within 28 days of study treatment\r\n             and confirmed prior to treatment on day 1. Postmenopausal is defined as: 1)\r\n             Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments,\r\n             2) Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post\r\n             menopausal range for women under 50, 3) radiation-induced oophorectomy with last\r\n             menses >1 year ago, 4) chemotherapy-induced menopause with >1 year interval since last\r\n             menses, 5) surgical sterilisation (bilateral oophorectomy or hysterectomy)\r\n\r\n          -  Patients is willing and able to comply with the protocol for the duration of the study\r\n             including undergoing treatment and scheduled visits and examinations.\r\n\r\n          -  Patients must have evaluable disease - define as one of the following: 12.1 RECIST 1.1\r\n             measurable disease OR, 12.2 Evaluable disease (defined as solid and cystic\r\n             abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for\r\n             target lesions OR ascites and/or pleural effusion that has been pathologically\r\n             demonstrated to be disease-related) in the setting of a CA125 > 2 times ULN.\r\n\r\n          -  Formalin fixed, paraffin embedded (FFPE) tumour sample from the primary cancer must be\r\n             available for central testing. If there is not written confirmation of the\r\n             availability of an archived tumour sample prior to enrolment the patient is not\r\n             eligible for the study. For inclusion in i) the optional exploratory genetic research\r\n             and ii) the optional biomarker research, patients must fulfil the following criteria:\r\n             1) Provision of informed consent for genetic research, 2) Provision of informed\r\n             consent for biomarker research\r\n\r\n          -  If a patient declines to participate in the optional exploratory genetic research or\r\n             the optional biomarker research, there will be no penalty or loss of benefit to the\r\n             patient. The patient will not be excluded from other aspects of the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Involvement in the planning and/or conduct of the study (applies to both AstraZeneca\r\n             staff and/or staff at the study site)\r\n\r\n          -  Previous enrollment or randomization in the present study\r\n\r\n          -  Participation in another clinical study with an investigational product during the\r\n             last 60 months\r\n\r\n          -  Concurrent enrollment in another clinical study, unless it is an observational\r\n             (non-interventional) clinical study or during the follow-up period of an\r\n             interventional study\r\n\r\n          -  Any previous treatment with poly ADP ribose polymerase(PARP) inhibitor (including\r\n             olaparib), anti-PD-1, PD-L1, CTLA-4 (including durvalumab and tremelimumab).\r\n\r\n          -  Other malignancy within the last 5 years except: adequately treated non-melanoma skin\r\n             cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ\r\n             (DCIS), Stage 1, grade 1 endometrial carcinoma, or other solid tumours including\r\n             lymphomas (without bone marrow involvement) curatively treated with no evidence of\r\n             disease for 5 years. Patients with a history of localised triple negative breast\r\n             cancer may be eligible, provided they completed their adjuvant chemotherapy more than\r\n             three years prior to registration, and that the patient remains free of recurrent or\r\n             metastatic disease\r\n\r\n          -  Resting ECG with Corrected QT Interval(QTc) > 470 msec on 2 or more time points within\r\n             a 24 hour period or family history of long QT syndrome\r\n\r\n          -  Patients receiving any systemic chemotherapy or radiotherapy (except for palliative\r\n             reasons) within 3 weeks prior to study treatment\r\n\r\n          -  Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine\r\n             therapy, targeted therapy, biologic therapy, tumour embolization, monoclonal\r\n             antibodies) 21 days prior to the first dose of study drug If sufficient wash-out time\r\n             has not occurred due to the schedule or Pharmacokinetics(PK) properties of an agent, a\r\n             longer wash-out period will be required, as agreed by AstraZeneca/MedImmune and the\r\n             investigator\r\n\r\n          -  Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment.\r\n             Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone\r\n             replacement therapy) is acceptable.\r\n\r\n          -  Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of\r\n             radiation within 4 weeks of the first dose of study drug\r\n\r\n          -  Concomitant use of known strong CYP3A inhibitors (eg. itraconazole, telithromycin,\r\n             clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir,\r\n             saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg.\r\n             ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout\r\n             period prior to starting olaparib is 2 weeks.\r\n\r\n          -  Concomitant use of known strong (eg. phenobarbital, enzalutamide, phenytoin,\r\n             rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort ) or\r\n             moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). The required washout\r\n             period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3\r\n             weeks for other agents.\r\n\r\n          -  Any unresolved toxicity NCI CTCAE Grade 2 from previous anticancer therapy with the\r\n             exception of alopecia, vitiligo, and the laboratory values defined in the inclusion\r\n             criteria : 1) Patients with Grade 2 neuropathy will be evaluated on a case-by-case\r\n             basis after consultation with the Principal Investigator. 2) Patients with\r\n             irreversible toxicity not reasonably expected to be exacerbated by treatment with\r\n             durvalumab or tremelimumab may be included only after consultation with the Principal\r\n             Investigator.\r\n\r\n          -  Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features\r\n             suggestive of Myelodysplastic syndrome/Acute myeloid leukemia(MDS/AML).\r\n\r\n          -  Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence\r\n             of brain metastases is not required. The patient can receive a stable dose of\r\n             corticosteroids before and during the study as long as these were started at least 4\r\n             weeks prior to treatment. Patients with spinal cord compression unless considered to\r\n             have received definitive treatment for this and evidence of clinically stable disease\r\n             for 28 days.\r\n      ","sponsor":"Yonsei University","sponsor_type":"Other","conditions":"Platinum-resistant Recurrent Ovarian Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: olaparib+cediranib combination therapy","description":"Cediranib (30mg p.o. qd) + Olaparib (200mg p.o. bid) until disease progression"},{"intervention_type":"Drug","name":"Drug: durvalumab + olaparib combination therapy","description":"Durvalumab (1500mg i.v. every 4 weeks starting on week 5 day1 for up to 12 months) + Olaparib (300mg p.o. bid) until disease progression"},{"intervention_type":"Drug","name":"Drug: durvalumab + chemotherapy treatment","description":"Durvalumab (1500mg i.v. every 4 weeks for up to 24 months) + non-platinum-based standard of care chemotherapy (weekly paclitaxel, topotecan, or Pegylated liposomal doxorubicin(PLD) up to 6 cycles)\r\nChemotherapy regimen:\r\nWeekly Paclitaxel 80mg/m2 (day 1,8,15,22 every 4 weeks), PLD (40mg/m2 on D1 every 4 weeks), topotecan (4mg/m2 on D1,8,15 every 4 weeks)"},{"intervention_type":"Drug","name":"Drug: durvalumab + tremelimumab + chemotherapy treatment","description":"Durvalumab (1500mg i.v. every 4 weeks for up to 24 months) + Tremelimumab (75mg i.v. every 4 weeks for up to 4 doses) + non-platinum-based standard of care chemotherapy (weekly paclitaxel, topotecan, or Pegylated liposomal doxorubicin (PLD) up to 4 cycles)\r\nChemotherapy regimen:\r\nWeekly Paclitaxel 80mg/m2 (day 1,8,15,22 every 4 weeks), PLD (40mg/m2 on D1 every 4 weeks), topotecan (4mg/m2 on D1,8,15 every 4 weeks)"},{"intervention_type":"Drug","name":"Drug: durvalumab + tremelimumab + paclitaxel treatment","description":"Durvalumab (1500mg i.v. every 4 weeks for up to 24 months) + Tremelimumab (300mg i.v. once) + non-platinum-based standard of care chemotherapy (weekly paclitaxel up to 4 cycles)\r\nChemotherapy regimen:\r\nWeekly Paclitaxel 60mg/m2 (day 1,8,15 every 4 weeks)"},{"intervention_type":"Drug","name":"Drug: durvalumab +chemotherapy treatment","description":"Durvalumab (1500mg i.v. every 4 weeks for up to 24 months) + non-platinum-based standard of care chemotherapy (paclitaxel, topotecan, or Pegylated liposomal doxorubicin(PLD) up to 4 cycles)\r\nChemotherapy regimen:\r\nWeekly Paclitaxel 80mg/m2 (day 1,8,15,22 every 4 weeks), PLD (40mg/m2 on D1 every 4 weeks), topotecan (4mg/m2 on D1,8,15 every 4 weeks)"}],"outcomes":[{"outcome_type":"primary","measure":"objective response rate by RECIST 1.1","time_frame":"6 months after treatment initiation","description":"The primary endpoint of the study is objective response rate by RECIST 1.1 (Time frame: up to 6 months after treatment initiation)"},{"outcome_type":"secondary","measure":"Progression-free survival(PFS)","time_frame":"up to 3 years"},{"outcome_type":"secondary","measure":"overall-survival(OS)","time_frame":"up to 3 years"},{"outcome_type":"secondary","measure":"immune-related Response Criteria","time_frame":"up to 3 years"},{"outcome_type":"secondary","measure":"Duration of response","time_frame":"up to 3 years"}]}
{"nct_id":"NCT03573453","start_date":"2018-11-25","phase":"N/A","enrollment":300,"brief_title":"Comparison of Continuous Versus Intermittent Enteral Nutrition in Critically Ill Patients.","official_title":"Comparison of Continuous Versus Intermittent Enteral Nutrition in Critically Ill Patients. Effect on Energy and Protein Target Achievement, Tolerance and Incidence of Complications. Monocentric Prospective Randomised Study.","primary_completion_date":"2021-11-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-11-01","last_update":"2021-03-03","description":"The purpose of the study is to compare continuous versus intermittent strategy for enteral nutrition. The study will examine if there is a difference in achieving nutritional delivery goals, tolerance and number of complications of enteral nutrition.","other_id":"CT0012018","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  age between 18 - 80 years\r\n\r\n          -  indication of enteral nutrition with nasogastric or orogastric tube\r\n\r\n          -  Nutrition Risk in the Critically Ill (NUTRIC) score 5\r\n\r\n          -  Body mass index between 18 - 50\r\n\r\n          -  mechanical ventilation expected for at least 72 hours\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  upper gastrointestinal tract surgery in previous medical history\r\n\r\n          -  bowel obstruction\r\n\r\n          -  bowel ischemia\r\n\r\n          -  acute pancreatitis\r\n\r\n          -  severe diarrhoea (>1l/24hours)\r\n\r\n          -  gastrointestinal bleeding\r\n\r\n          -  short bowel syndrome\r\n\r\n          -  malabsorption syndrome in previous medical history\r\n\r\n          -  ongoing enteral nutrition on admission to ICU\r\n      ","sponsor":"Masaryk University","sponsor_type":"Other","conditions":"Nutrition Disorders","interventions":[{"intervention_type":"Other","name":"Other: enteral nutrition","description":"administration of enteral nutrition"}],"outcomes":[{"outcome_type":"primary","measure":"Energy target","time_frame":"5 days from initiation of enteral nutrition","description":"Daily assessment of energy intake in critically ill patients with enteral nutrition.Energy target will be achieved if at least 80% of calculated energy intake will be delivered."},{"outcome_type":"secondary","measure":"Protein target","time_frame":"5 days from initiation of enteral nutrition","description":"Daily assessment of protein intake in critically ill patients with enteral nutrition.Protein target will be achieved if at least 80% of calculated protein intake will be delivered."},{"outcome_type":"secondary","measure":"Tolerance of enteral nutrition","time_frame":"5 days from initiation of enteral nutrition","description":"Measurement of the gastric residual volume"},{"outcome_type":"secondary","measure":"Tolerance of enteral nutrition","time_frame":"5 days from initiation of enteral nutrition","description":"Incidence of diarrhoea"},{"outcome_type":"secondary","measure":"Tolerance of enteral nutrition","time_frame":"5 days from initiation of enteral nutrition","description":"Incidence of vomiting"},{"outcome_type":"secondary","measure":"Complications of enteral nutrition","time_frame":"5 days from initiation of enteral nutrition","description":"Incidence of aspiration and ventilator associated pneumonia"},{"outcome_type":"secondary","measure":"Nutritional status","time_frame":"On admission and day 5 from initiation of enteral nutrition","description":"Blood test : total serum protein test"},{"outcome_type":"secondary","measure":"Nutritional status","time_frame":"On admission and day 5 from initiation of enteral nutrition","description":"Blood test : albumin test"},{"outcome_type":"secondary","measure":"Nutritional status","time_frame":"On admission and day 5 from initiation of enteral nutrition","description":"Blood test : prealbumin test"},{"outcome_type":"other","measure":"ICU and hospital length of stay","time_frame":"through study completion, an average of 3 weeks"},{"outcome_type":"other","measure":"28-day mortality","time_frame":"28 days from randomisation"}]}
{"nct_id":"NCT03596268","start_date":"2018-11-20","enrollment":240,"brief_title":"Functional Imaging Reserve in NeuroHIV","official_title":"Functional Imaging Reserve in NeuroHIV","primary_completion_date":"2023-07-31","study_type":"Observational [Patient Registry]","rec_status":"Recruiting","completion_date":"2023-07-31","last_update":"2021-07-14","description":"The purpose of this research study is to look at the brain's efficiency and ability to make up for deficits in the front of the brain to see if people living with HIV (PLWH) are still able to perform well on various cognitive tasks even though there are other underlying processes at work, like inflammation, that affect the brain in a negative way. Results of this study may provide insight into the pathophysiology of disease and may reveal arenas for future possible interventions in PLWH who have impaired neuropsychological performance.","other_id":"201805047","observational_model":"Case-Control","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":20,"maximum_age":80,"population":"Adult persons living with HIV (PLWH) and demographically similar healthy HIV- controls","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  20 to 80 years old\r\n\r\n          -  documented HIV infection for at least 1 year or confirmed HIV - status\r\n\r\n          -  PLWH must be on stable cART regimen for at least 12 months with undetectable plasma\r\n             HIV RNA (less than 50 copies per mL)\r\n\r\n          -  at least 9 years of education\r\n\r\n          -  able to provide informed consent\r\n\r\n          -  if female, a negative pregnancy test and not breast feeding\r\n\r\n          -  able to undergo an MRI scan\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  significant neurological disorders (e.g. stroke, head injury with loss of\r\n             consciousness for more than 5 minutes, developmental learning disability)\r\n\r\n          -  active uncontrolled Axis I psychiatric disorder according to the DSM 5\r\n\r\n          -  current or history of substance use disorder (including, but not limited to\r\n             amphetamines, cocaine, alcohol, opiates, and barbiturates)\r\n\r\n          -  prescribed blood thinners\r\n\r\n          -  allergic to lidocaine or similar anesthetic\r\n\r\n          -  history of any bleeding disorder\r\n\r\n          -  contraindication to MRI scanning (e.g. claustrophobia, pacemaker, etc.)\r\n\r\n          -  pregnant or breastfeeding\r\n      ","sponsor":"Washington University School of Medicine","sponsor_type":"Other","conditions":"HIV","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Imaging","description":"3T Prisma MRI"},{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Serum Laboratory Tests","description":"Blood (plasma and cellular) will be collected."},{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Lumbar Puncture","description":"CSF will be collected"}],"outcomes":[{"outcome_type":"primary","measure":"Brain Efficiency and Recruitment - Determine the neuroimaging signatures of brain efficiency and recruitment in virologically suppressed PLWH.","time_frame":"5 years","description":"The investigators will compare the recruitment of compensatory networks between the PLWH and HIV- controls using multiple linear regression. In exploratory analyses the investigators will compare the brain efficiency between PLWH and HIV-, using similar multiple regression models, controlling for confounders. Among PLWH, the investigators will study the association of brain efficiency with neuropsychological performance testing using multiple regression models."},{"outcome_type":"secondary","measure":"Effects of Aging - Determine the effects of aging on brain efficiency and recruitment in virologically suppressed PLWH.","time_frame":"5 years","description":"The investigators will compare the recruitment (response) between the four HIV age groups (HIV- <50 year old, HIV- ≥50 years old, HIV+ <50 years old, and HIV+ ≥50 years old) using a multiple regression (ANCOVA) model, adjusting for potential confounders (age, sex, education, past substance use, and CVD). The pairwise comparisons of primary interest is between the HIV- <50 years old and the HIV- ≥50 years old groups. Among the PLWH only, the investigators will compare the brain efficiency r (response) between the younger and older group using multiple regression, adjusting for potential confounders. Secondly, a mediation analysis will examine the role of immune dysfunction (activation and exhaustion) markers as mediators of this relationship."}]}
{"nct_id":"NCT03823638","start_date":"2018-11-20","phase":"Phase 2","enrollment":60,"brief_title":"Safety, Tolerability and Effects of Mannitol in Parkinson's Disease","official_title":"A Phase II Single Center, Randomized, Double Blind and Placebo Controlled Study Assessing the Safety, Tolerability and Effects of Progressively Increased Dose of Oral Mannitol in Parkinson's Disease","primary_completion_date":"2020-07-01","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2020-12-31","last_update":"2019-01-30","description":"Parkinson's disease is a progressive neurodegenerative disease that causes disabling motor and cognitive impairments. Currently, no disease-modifying therapy exists for this disease. Mannitol, a naturally-occurring substance, which is commonly used as sweetener, was offered as such agent. In this phase II, safety, tolerability-based dose finding, and efficacy study, mannitol or placebo (dextrose) in escalating doses will be given to patients with Parkinson's disease for 36 weeks.","other_id":"0346-17-HMO-CTIL","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":40,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Ability to understand and signing of informed consent form.\r\n\r\n          2. Age 40-75 years at the day of visit 1.\r\n\r\n          3. Diagnosis of Parkinson's disease that is based on the United Kingdom brain bank\r\n             criteria diagnosed after the age of 40.\r\n\r\n          4. Stable regime of anti-parkinsonian medication for at least 4 weeks at the day of visit\r\n             1.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients with motor deficits that require administration of symptomatic therapy more\r\n             than 4 times per day at the day of visit 1.\r\n\r\n          2. Patients on advanced therapy for Parkinson's disease (sub-cutaneous apomorphine, deep\r\n             brain stimulation or intra-jejunal levodopa infusion).\r\n\r\n          3. Patients with dementia reflected by a Mini-mental state examination (MoCA)  24.\r\n\r\n          4. Patient with legal guardian.\r\n\r\n          5. History of psychosis or use of dopamine receptor blocking agent on the year proceeding\r\n             at the visit 1. Quetiapine at dose lower or equal 50 mg per day prescribed for\r\n             indication other than psychosis is allowed.\r\n\r\n          6. Suspected Parkinsonian syndrome other than Parkinson's disease.\r\n\r\n          7. Use of medical marihuana on the month proceeding visit 1.\r\n\r\n          8. Pregnant or lactating women, or fertile woman who does not use contraceptive. Woman of\r\n             child-bearing potential must have a negative urine Human chorionic gonadotropin (hCG)\r\n             and will be monitored by repeated urine tests.\r\n\r\n          9. Patient with significantly impaired renal functions (urea or creatinine values 20%\r\n             above the upper norm limit).\r\n\r\n         10. Diabetes mellitus.\r\n\r\n         11. Clinical evidence for congestive heart failure.\r\n\r\n         12. Patient with symptomatic orthostatic hypotension.\r\n\r\n         13. Based on investigator's opinion, any medical condition that may progress due to\r\n             consumption of oral mannitol or glucose.\r\n      ","sponsor":"Hadassah Medical Organization","sponsor_type":"Other","conditions":"Parkinson Disease","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Oral D-Mannitol of Placebo","description":"Gradually increased doses of oral D-Mannitol of Placebo (Dextrose monohydrate)"}],"outcomes":[{"outcome_type":"primary","measure":"Safety of oral mannitol in Parkinson's disease as assessed by the number of mannitol-related adverse events, clinically significant changes in vital signs and clinically significant abnormalities in laboratory results.","time_frame":"36 weeks","description":"Safety will be assessed by the number of treatment-related adverse events, number of patients with clinically significant change of vital signs (supine and standing blood pressure and pulse) and number of patients with clinically significant change in laboratory results (electrolytes, renal and liver functions, blood count)."},{"outcome_type":"primary","measure":"Tolerability of oral mannitol in Parkinson's disease as assessed by the maximal daily dose (in grams) of mannitol that does not cause discomfort.","time_frame":"36 weeks","description":"Tolerability of oral mannitol in Parkinson's disease as assessed by the maximal daily dose (in grams, up to 18 grams per day) of mannitol that does not cause discomfort based on the subjective report by the patient."},{"outcome_type":"secondary","measure":"Time-interval for starting symptomatic therapy (in days) between baseline and week 36, in patients not receiving symptomatic therapy at baseline.","time_frame":"36 weeks","description":"Median time interval will be reported. P-Values as assessed by Mann-Whitney test will be reported. Longer time interval will be considered as a better outcome."},{"outcome_type":"secondary","measure":"Change in levodopa-equivalent dose units between baseline and week 36.","time_frame":"36 weeks","description":"Total levodopa-equivalent dose (LED units) will be calculated based on Tomlinson, Mov Disord 2010. P-Values as assessed by Mann-Whitney test will be reported. Smaller change will be considered as a better outcome."},{"outcome_type":"secondary","measure":"Change of Brief Smell Identification Test (B-SIT) score between baseline and week 36.","time_frame":"36 weeks","description":"Median and range of change will be reported. P-Values as assessed by Mann-Whitney test will be reported. Higher absolute positive value (reflecting improved smell) or lower absolute negative value (slower deterioration) will be considered as better outcomes."},{"outcome_type":"secondary","measure":"Change in constipation assesment (CAS) score between baseline and week 36.","time_frame":"36 weeks","description":"Median and range of change will be reported. Change in score will be reported. P-Values as assessed by Mann-Whitney test will be reported. Lower absolute positive value or higher absolute negative value will be considered as better outcomes."},{"outcome_type":"secondary","measure":"Change in Montreal Cognitive Assessment (MoCA) test score between baseline and week 36.","time_frame":"36 weeks","description":"P-Values as assessed by Mann-Whitney test will be reported. Higher absolute positive value or lower absolute negative value will be considered as better outcomes."},{"outcome_type":"secondary","measure":"Change in non-motor symptoms of Parkinson's disease scale (NMSS) between baseline and week 36.","time_frame":"36 weeks","description":"Median and range of change will be reported. P-Values as assessed by Mann-Whitney test will be reported. Lower absolute positive value or higher absolute negative value will be considered as better outcomes."},{"outcome_type":"secondary","measure":"Change in the ratio of total-to-proteinase K-resistant α-synuclein in red blood cells (RBC) measured by enzyme-linked immunosorbent assay (ELISA)between baseline and week 36.","time_frame":"36 weeks","description":"Median and range of change will be reported. P-Values as assessed by Mann-Whitney test will be reported. Higher absolute positive value or lower absolute negative value will be considered as better outcomes."}]}
{"nct_id":"NCT03742622","start_date":"2018-11-17","phase":"N/A","enrollment":14,"brief_title":"Energy Intake, Exercise and Energy Replacement","official_title":"Does Energy Replacement Modify Post-exercise Energy Intake in Adolescents With Obesity?","primary_completion_date":"2019-03-03","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-03-03","last_update":"2019-09-12","description":"The aim of the present study is to compare the effect of an exercise alone versus. An exercise followed by the ingestion of an energy replacement snack on the following energy intake, food reward and appetite feelings in adolescents with obesity.","other_id":"CHU-415","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":12,"maximum_age":16,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  BMI percentile > 97th percentile according to the french curves.\r\n\r\n          -  ages 12-16 years old\r\n\r\n          -  Signed consent form\r\n\r\n          -  being registered in the national social security system\r\n\r\n          -  no contraindication to physical activity\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Previous surgical interventions that is considered as non-compatible with the study.\r\n\r\n          -  Diabetes\r\n\r\n          -  weight loss during the last 6 months\r\n\r\n          -  cardiovascular disease or risks\r\n      ","sponsor":"University Hospital, Clermont-Ferrand","sponsor_type":"Other","conditions":"Pediatric Obesity","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: CON . control condition without exercise / rest condition","description":"CON . Control condition without exercise / rest condition. The adolescents will be asked to remain quiet and at rest during the morning and will receive an ad libitum meal at lunch and dinner times. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals."},{"intervention_type":"Behavioral","name":"Behavioral: EX. Condition with an acute exercise set in the middle of the morning","description":"EX. Condition with an acute exercise set in the middle of the morning The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling) in the morning and will receive an ad libitum meal at lunch and dinner times. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals"},{"intervention_type":"Behavioral","name":"Behavioral: EX+R. condition with an acute exercise set in the morning and followed by a energy replacement snack","description":"EX+R. condition with an acute exercise set in the morning and followed by a energy replacement snack The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling) in the morning followed by a snack that will cover the whole exercise-induced energy expenditure. They will then receive an ad libitum meal at lunch and dinner times. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals."}],"outcomes":[{"outcome_type":"primary","measure":"Energy intake measured during an ad libitum buffet meal (in kcal).","time_frame":"at lunch (at day 1)","description":"food intake will be measured ad libitum during a lunch buffet. The adolescents will be offered an ad libitum buffet-type meal composed based on their food intake preferences. Their intake will be weighted using an electronic food scale by a member of the investigation team and then analysed using Bilnuts software"},{"outcome_type":"secondary","measure":"Measurement of hunger feelings","time_frame":"at day 1","description":"hunger area under the curve will be assessed using visual analogue scale through a the day (Leeds Food Preference Questionnaire; LFPQ) Briefly, the LFPQ provides measures of the wanting and liking for an array of food images, varying in both fat content and taste"},{"outcome_type":"secondary","measure":"Food reward","time_frame":"at day 1","description":"The participants will be asked to complete a validated computer-based procedure to measure food reward (Leeds Food Preference Questionnaire; LFPQ) (Finlayson, King et al. 2008).Briefly, the LFPQ provides measures of the wanting and liking for an array of food images, varying in both fat content and taste"}]}
{"nct_id":"NCT03693924","start_date":"2018-11-15","enrollment":100,"brief_title":"A Retrospective Evaluation of Superficial Radiation Therapy (SRT) and Keloid Scars.","official_title":"A Retrospective Registry Study to Evaluate the Long-Term Efficacy and Safety of Superficial Radiation Therapy (SRT) for the Treatment of Recurrent Keloid Scars.","primary_completion_date":"2019-02-16","study_type":"Observational","rec_status":"Unknown status","completion_date":"2019-02-16","last_update":"2018-10-03","description":"Keloid formation in response to skin trauma inflicts about 18 million individuals. A key impediment in successful treatment of keloids is that the predominant treatments, particularly surgical excision and shaving, tend to initiate the regrowth of the keloid at the excision site, and therefore, recurrence rates are high. There is much evidence to demonstrate that following surgical excision procedures with a course of radiation therapy can significantly reduce recurrence rates to as little as 10% or below. This retrospective study is to evaluate this claim.","other_id":"SRTS-SRT-002","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"The study population comprises patients who were treated with the SRT-100 for one or more\r\n        recurrent keloids and who have at least 1 year of follow-up data.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Confirmed diagnosis of keloid(s).\r\n\r\n          -  Treatment with SRT-100 of one or more keloids.\r\n\r\n          -  At least 1 year since treatment end.\r\n\r\n          -  Required retrospective data is existing and sufficient.\r\n\r\n        Exclusion Criteria\r\n\r\n          -  Lesions of etiology other than keloids.\r\n      ","sponsor":"Sensus Healthcare","sponsor_type":"Industry","conditions":"Keloid Scar","interventions":[{"intervention_type":"Radiation","name":"Radiation: SRT-100","description":"The SRT-100 is a simple painless non-invasive in-office procedure that is approved by the U.S. Food and Drug Administration (U.S. FDA) to treat keloids caused by surgery or injury by delivering a precise, calibrated dose of Superficial Radiation Therapy (SRT) that only goes skin deep."}],"outcomes":[{"outcome_type":"primary","measure":"Long-term recurrence rate","time_frame":"one year","description":"Recurrence rate will be calculated as the percentage of keloids that recurred at the treatment site following treatment completion."}]}
{"nct_id":"NCT03663322","start_date":"2018-11-15","phase":"N/A","enrollment":100,"brief_title":"Diabetes and Osteopathic Manipulative Medicine (OMM)","official_title":"Diabetes and Osteopathic Manipulative Medicine: A Randomized Controlled Trial","primary_completion_date":"2020-08-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2021-02-28","last_update":"2019-04-25","description":"Our research team is proposing a study to investigate the effects of osteopathic manipulative treatment on the blood sugar levels of persons with Type 2 diabetes. The goal of this study is to determine if osteopathic manipulative treatment (OMT) can improve the blood sugar levels of individuals with Type 2 diabetes. Half of the participants will receive osteopathic manipulative treatment (OMT) and the other will receive OMT-sham treatment.","other_id":"BHS-1383","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":30,"maximum_age":90,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Clinical diagnosis of Type II diabetes\r\n\r\n          -  Able to provide consent for participation\r\n\r\n          -  Currently taking only oral diabetic medication(s)\r\n\r\n          -  Prior hemoglobin A1C test result\r\n\r\n          -  Able to fast for the glucose measurements\r\n\r\n          -  Able to complete the intake and consent documents\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Insulin dependent diabetes\r\n\r\n          -  Unable or unwilling to provide informed consent\r\n\r\n          -  Unable to fast for the glucose measurements\r\n\r\n          -  Have an absolute contraindication to OMT (i.e. Acute fracture, joint dislocation, an\r\n             open wound or infection)\r\n\r\n          -  Pregnant women\r\n      ","sponsor":"New York Institute of Technology","sponsor_type":"Other","conditions":"Type2 Diabetes Mellitus|Osteopathy in Diseases Classified Elsewhere","interventions":[{"intervention_type":"Procedure","name":"Procedure: OMT Protocol","description":"Selected hands-on OMT techniques intended to improve pancreatic function will be administered during the treatment sessions"},{"intervention_type":"Procedure","name":"Procedure: OMT-Sham Protocol","description":"Selected hands-on Sham-OMT techniques that are not intended to affect pancreatic function will be administered during the treatment sessions"}],"outcomes":[{"outcome_type":"primary","measure":"Fasting glucose","time_frame":"3 months","description":"Short term fasting glucose levels"},{"outcome_type":"secondary","measure":"A1C","time_frame":"3 months","description":"Short term A1C levels"}]}
{"nct_id":"NCT03754452","start_date":"2018-11-09","enrollment":100,"brief_title":"Evaluation of the Sarcopenia in Hepatobiliary Surgery","official_title":"Evaluation of the Prevalence, the Diagnosis Tests, and the Associated Morbimortality of Sarcopenia in Hepatobiliary Surgery","primary_completion_date":"2020-01-01","study_type":"Observational","rec_status":"Unknown status","completion_date":"2020-02-01","last_update":"2018-11-28","description":"The sarcopenia is defined as a loss of muscle mass and a loss of muscle function ( strength or performance). Some studies showed that the sarcopenia increase the postoperative complications and the overall survival in abdominal surgery. But the sarcopenia is not evaluated in the Hepatobiliary surgery. This prospective, monconcentrique study aim to evaluate the prevalence of sarcopenia, and its associated morbimortality in hepatobiliary surgery for malignant or benign tumors.","other_id":"2018-A1104-51","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"- all patients who should have a hepatobiliary surgery for malignant and benign tumor in\r\n        the universitary hospital center of Angers","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  hepatobiliary surgery\r\n\r\n          -  scheduled surgery\r\n\r\n          -  oral consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  pregnancy\r\n\r\n          -  patient under low protection\r\n\r\n          -  emergency surgery\r\n\r\n          -  hepatic encephalopathy stage II, III and IV\r\n      ","sponsor":"University Hospital, Angers","sponsor_type":"Other","conditions":"Sarcopenia|Hepatobiliary Disease|Postoperative Complications|Surgery","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"the number of patients with a sarcopenia before having a hepatobiliary surgery mesured by impedancemetry and by the muscular force or the speed walking","time_frame":"1 month","description":"for the man : i/impedancemetry BMI<8,87kg/m2 and ii/ a muscular force < 30kg or a walking speed <0,8m/s"},{"outcome_type":"primary","measure":"the number of patients with a sarcopenia before having a hepatobiliary surgery mesured by impedancemetry and by the muscular force or the speed walking","time_frame":"1 month","description":"for the woman: i/impedancemetry BMI<6,42kg/m2 and ii/muscular force < 20kg or a walking speed <0,8m/s"},{"outcome_type":"secondary","measure":"comparison between the impedancemetry and the abdominopevis CT for the diagnosis of sarcopenia","time_frame":"3 months","description":"impedancemetry used to evaluate the muscular mass\r\nabdominopelvis CT evualate the muscular mass by measuring the muscular area on the L3 section"},{"outcome_type":"secondary","measure":"comparison of the postoperatives complications using the clavien dindo classsification between the patient with sarcopenia and the patient without sarcopenia.","time_frame":"4 months","description":"postoperatives complications evualuated according the clavien dindo classification are : death, nausea, vomit, need of nasogastric tube, liver failure with jaundice, ascites, liver encephalopathy, biliary fistula, biliary peritonitis, hernia, parietal abcess, urinary infection, urinary retention, hematoma, pulmonary embolism, pulmonary infection, pleural effusion, atelectasis, renal failure, hyponatremia, hypernatremia, hypokaliema, hyperkaliema the post operative complication evaluate"}]}
{"nct_id":"NCT03802799","start_date":"2018-11-09","phase":"Phase 2/Phase 3","enrollment":300,"brief_title":"Open Label Extension to Assess the Long-Term Safety and Tolerability of ZYN002 in Children and Adolescents With FXS","official_title":"An Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of ZYN002 Administered as a Transdermal Gel to Children and Adolescents With Fragile X Syndrome - CONNECT-FX Open Label Extension (OLE)","primary_completion_date":"2022-02-28","study_type":"Interventional","rec_status":"Enrolling by invitation","completion_date":"2022-02-28","last_update":"2021-04-28","description":"ZYN002 is a pharmaceutically manufactured Cannabidiol (CBD) that is developed as a clear gel that can be applied to the skin (called transdermal delivery). The gel will be applied to clean, dry, intact skin of the shoulders and/or upper arms. Only participants from the ZYN2-CL-016 study who meet the inclusion criteria and none of the exclusion criteria for study ZYN2-CL-017 are eligible. Parents/caregivers will apply the study gel twice daily for the 52-week treatment period.","other_id":"ZYN2-CL-017","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Open-Label","sampling_method":"","gender":"All","minimum_age":3,"maximum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Participated in the ZYN2-CL-016 study.\r\n\r\n          -  Patients and parents/caregivers agree to abide by all study restrictions and comply\r\n             with all study procedures.\r\n\r\n          -  Patients and parents/caregivers must be adequately informed of the nature, risks of\r\n             the study, and give written informed consent prior to enrollment in ZYN2-CL-017.\r\n\r\n          -  In the Investigator's opinion, the patients and parents/caregivers are reliable and\r\n             are willing and able to comply with all protocol requirements and procedures.\r\n\r\n          -  Females of childbearing potential must have a negative pregnancy test at all\r\n             designated visits\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patient is receiving any investigational drugs (not ZYN002) or using any experimental\r\n             devices.\r\n\r\n          -  Patient has an ongoing serious adverse event (SAE) or has experienced a SAE in\r\n             ZYN2-CL-016, which in the opinion of the Investigator, should exclude them from\r\n             participation.\r\n\r\n          -  Females who are pregnant, nursing, or planning a pregnancy; females of childbearing\r\n             potential and male patients with a partner of childbearing potential who are unwilling\r\n             or unable to use an acceptable method of contraception for the duration of therapy and\r\n             for three months after the last dose of trial drug.\r\n\r\n          -  Patients who have alanine aminotransferase (ALT), aspartate aminotransferase (AST), or\r\n             total bilirubin levels >= 2 times the upper limit of normal (ULN) or has alkaline\r\n             phosphatase levels >= 3 times the ULN as determined from patient safety laboratories.\r\n      ","sponsor":"Zynerba Pharmaceuticals, Inc.","sponsor_type":"Industry","conditions":"Fragile X Syndrome","interventions":[{"intervention_type":"Drug","name":"Drug: ZYN002 - CBD Transdermal Gel","description":"Pharmaceutically manufactured. Cannabidiol (CBD) formulated as a clear gel (transdermal delivery)"}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of treatment-emergent adverse events (safety and tolerability)","time_frame":"Up to 1 year","description":"Safety assessment will include collection of any treatment emergent adverse events"},{"outcome_type":"secondary","measure":"Aberrant Behavior Checklist-Community, Fragile X Factor Structure (ABC-C FXS) Pre-specified Subscale 1","time_frame":"Change from baseline to end of treatment, an average of 1 year","description":"The ABC-C is a standard parent/caregiver reported behavioral outcome measure for use in developmental disability clinical trials."},{"outcome_type":"secondary","measure":"Aberrant Behavior Checklist-Community, Fragile X Factor Structure (ABC-C FXS) Pre-specified Subscale 2","time_frame":"Change from baseline to end of treatment, an average of 1 year","description":"The ABC-C is a standard parent/caregiver reported behavioral outcome measure for use in developmental disability clinical trials."},{"outcome_type":"secondary","measure":"Clinical Global Impression- Improvement (CGI-I)","time_frame":"Change from baseline to end of treatment, an average of 1 year","description":"The CGI-I global improvement item is a 7-point Likert scale designed to measure behavioral symptomatic change at a specific time compared to baseline. CGI-I is a standard global measure of potential change with treatment in placebo-controlled pharmacotherapy trials in developmental disabilities."}]}
{"nct_id":"NCT03696992","start_date":"2018-11-08","phase":"N/A","enrollment":894,"brief_title":"BLI, NBI or White Light Colonoscopy for Proximal Colonic Adenoma","official_title":"Blue Laser Imaging Versus Narrow Band Imaging Versus White Light Imaging for Detection of Adenoma in the Proximal Colon: A Prospective Randomized Study","primary_completion_date":"2022-03-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-12-31","last_update":"2021-03-29","description":"This is a prospective randomised trial comparing the proximal adenoma detection rate and miss rate by blue laser imaging (BLI), narrow band imaging or white light colonoscopy.","other_id":"UW18-420","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Diagnostic","masking_description":"Single","intervention_model_description":"Prospective randomized design","sampling_method":"","gender":"All","minimum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age 40 or above\r\n\r\n          -  scheduled for colonoscopy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  unable to provide informed consent\r\n\r\n          -  have undergone previous colorectal resection,\r\n\r\n          -  personal history of colorectal cancer, inflammatory bowel disease, familial\r\n             adenomatous polyposis, Peutz-Jeghers syndrome, or other polyposis syndromes.\r\n\r\n          -  Patients who are considered to be unsafe for polypectomy including patients with\r\n             bleeding tendency and those with severe comorbid illnesses\r\n\r\n          -  poor bowel preparation\r\n      ","sponsor":"The University of Hong Kong","sponsor_type":"Other","conditions":"Colon Adenoma","interventions":[{"intervention_type":"Procedure","name":"Procedure: Tandem colonoscopy","description":"Tandem colonoscopy with different image modalities"}],"outcomes":[{"outcome_type":"primary","measure":"Proximal adenoma detection rate","time_frame":"one day","description":"proportion of patients with proximal adenoma detected on first examination"},{"outcome_type":"secondary","measure":"proximal polyp detection rate","time_frame":"one day","description":"proportion of patients with proximal polyp detected on first examination"},{"outcome_type":"secondary","measure":"proximal adenoma miss rate","time_frame":"one day","description":"proportion of patients with proximal adenoma detected on second examination"},{"outcome_type":"secondary","measure":"proximal polyp miss rate","time_frame":"one day","description":"proportion of patients with proximal polyp detected on second examination"}]}
{"nct_id":"NCT03863262","start_date":"2018-11-08","enrollment":1203,"brief_title":"Screening for Depression in cADiovasCular pAtients at a Tertiary Center in Trinidad.","official_title":"Screening for Depression in cADiovasCular pAtients at a Tertiary Center in Trinidad.","primary_completion_date":"2019-02-20","study_type":"Observational","rec_status":"Completed","completion_date":"2019-02-20","last_update":"2019-12-03","description":"This was an observational study aimed to screen patients with cardiovascular disease for depression in Trinidad and Tobago in a tertiary center and to determine if there is a significant association between patients with symptoms of depression and other comorbidities. Patients (N=1203) were randomly selected from the outpatient cardiology clinics at the Eric Williams Medical Sciences Complex. After fulfilling the inclusion criteria and informed consent were obtained, they were given the case report form which included the Patient Health Questionnaire 9.","other_id":"CEC691/08/18","observational_model":"Other","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"The number of participants in this study was 1203 patients. There were no dropped subjects\r\n        from the study nor were there any incomplete questionnaires by any participants. The sample\r\n        size for this study was calculated to be 1159 patients.\r\n\r\n        Based on a study done by Huffman, it was estimated that 40% of patients with cardiovascular\r\n        disease also have depression(2). The Type I error rate 5% ( = 0.05) making the Type II\r\n        error rate 95% ( = 0.95) with a statistical power of 90%. Assuming a 10% patient decline\r\n        and attrition rate and a minimum detectable difference of 10%, the estimated sample size\r\n        was calculated to be 1159 patients.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Registered patients at Eric Williams Medical Sciences Complex in any of the cardiology\r\n             outpatient clinics. This was confirmed by matching patients with their registration\r\n             numbers on the cardiology outpatient clinic appointment listings. These lists are made\r\n             prior to each cardiology clinic that is scheduled every week on Mondays, Tuesdays,\r\n             Wednesdays, Thursdays and Fridays.\r\n\r\n          -  Patients who were 18 years old\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients less than 18 years old\r\n\r\n          -  Those who did not give informed consent to participate in the study\r\n\r\n          -  Patients who were not registered patients of the cardiology outpatient clinics at Eric\r\n             Williams Medical Sciences Complex along\r\n\r\n          -  Patients who were acutely unwell requiring hospital admission\r\n      ","sponsor":"The University of The West Indies","sponsor_type":"Other","conditions":"Depression","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Percentage of cardiovascular patients with a PHQ9 Score > 10","time_frame":"4 months","description":"The percentage of cardiovascular patients with a screening for depression score > 10."},{"outcome_type":"secondary","measure":"Demographic associations with a PHQ9 Score >10.","time_frame":"4 months","description":"Demographic associations with respect to a PHQ Score >10"}]}
{"nct_id":"NCT03698968","start_date":"2018-11-06","phase":"N/A","enrollment":50,"brief_title":"Performance, Safety and Efficacy of PICO Device.","official_title":"A Prospective Follow up Study to Assess Performance, Safety and Efficacy of the PICO 7 NPWT System for Surgically Closed Incision Sites and Skin Grafts.","primary_completion_date":"2019-06-18","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-06-18","last_update":"2019-09-18","description":"The study is being conducted to evaluate the safe and effective use of the PICO 7 system in surgically closed incision sites and wounds requiring closure by skin graft or flap as part of the PMCF plan for this product, for the purpose of continuing CE (Conformit Europene) Mark approval in accordance with MEDDEV 2.12-2","other_id":"CT1703PC7","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  The subject must provide written informed consent\r\n\r\n          -  Subjects eighteen (18) years of age or older.\r\n\r\n          -  Willing and able to make all required study visits.\r\n\r\n          -  Able to follow instructions.\r\n\r\n          -  Subject is suitable to participate in the study in the opinion of the Investigator\r\n\r\n          -  Subject has a suitable, closed abdominal or knee surgery incision skin flap or skin\r\n             graft (STSG, meshed or non-meshed) (if there is more than one incision then the\r\n             clinician should choose the one which in their opinion is most suited to PICO\r\n             therapy), that fits under the absorbent dressing area of the appropriate PICO 7\r\n             dressing supplied.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Contraindications (per the PICO 7 IFU) or hypersensitivity to the use of the\r\n             investigational product or their components (e.g. silicone adhesives and polyurethane\r\n             films [direct contact with incision], acrylic adhesives [direct contact with skin],\r\n             polyethylene fabrics and super-absorbent powders [polyacrylates]) within the\r\n             dressing).\r\n\r\n          -  Subjects with extremely fragile skin who require the use of SECURA non-sting barrier\r\n             skin wipes and have hypersensitivity to the ingredients in the wipes\r\n\r\n          -  Participation in the treatment period of another clinical trial within thirty (30)\r\n             days of operative visit or during the study.\r\n\r\n          -  Subjects with skin features (e.g. tattoos, skin colour, pre-existing scarring) which\r\n             in the opinion of the Investigator, will interfere with the study assessments.\r\n\r\n          -  Patients undergoing a procedure as part of palliative care (to be confirmed during\r\n             surgery).\r\n\r\n          -  Subjects with incisions or skin grafts that are actively bleeding unless haemostasis\r\n             has been achieved (to be confirmed during surgery).\r\n\r\n          -  Subjects with infected skin grafts or incisions at the time of surgery (except for\r\n             those with perforated bowel or peritonitis).\r\n\r\n          -  Subjects who have participated previously in this clinical trial\r\n\r\n          -  Subjects with a history of poor compliance with medical treatment.\r\n\r\n          -  Subjects with skin grafts to correct pressure ulcers where compression therapy is\r\n             needed for healing (based on clinicians expertise).\r\n\r\n          -  Subjects with a medical or physical condition that, in the opinion of the\r\n             Investigator, would preclude safe subject participation in the study.\r\n      ","sponsor":"Smith & Nephew, Inc.","sponsor_type":"Industry","conditions":"Wound Heal","interventions":[{"intervention_type":"Device","name":"Device: Negative Pressure Wound Therapy","description":"Single use disposable negative pressure system. The system is capable of delivering up to 80 mm Hg negative pressure to a wound or surgical incision site and managing low to moderate levels of exudate or fluid generated by the wound or incision. The therapy may be administered for up to 1 week."}],"outcomes":[{"outcome_type":"primary","measure":"Composite Clinical Success","time_frame":"7 Days","description":"Composite Clinical Success (CCS) defined as a binary variable (1/0) (1 if both of the following are true and 0 if at least one of the two is false):\r\nA. Nominal pressure is in the interval 80mmHg ± 7mmHg\r\nB. No leakage"},{"outcome_type":"secondary","measure":"Number of participants with incidence of Surgical Site Infection (SSI) - Superficial, deep. [CDC criteria]","time_frame":"30 Days","description":"For incidence of SSI and incidence of SSC binary variables indicating presence of/absence of will be defined and the frequencies together with percentages reported/identified outcomes will be reported. Logistic models will be fitted and associated factors adjusted for if there is adequate data"},{"outcome_type":"primary","measure":"Functional clinical performance of the PICO 7 NPWT system through delivery of negative pressure","time_frame":"7 Days","description":"Negative pressure maintenance at nominal 80 mmHg as assessed as the average of the negative pressure values recorded by the device microchip"},{"outcome_type":"primary","measure":"Functional clinical performance of the PICO 7 NPWT system through wound exudate management","time_frame":"7 Days","description":"Number of NPWT systems with no occurrence of exudate leaks as assessed through a combination of leakage alert data from device microchip and/or clinical data on any leakage observed during the dressing wearing period resulting or not, in an unplanned dressing change"},{"outcome_type":"secondary","measure":"Number of participants with incidence of Surgical Site Complications (SSC) - dehiscence (superficial/deep etc.), seroma, necrosis, hematoma, suture abscess","time_frame":"30 Days","description":"For incidence of SSI and incidence of SSC binary variables indicating presence of/absence of will be defined and the frequencies together with percentages reported/identified outcomes will be reported. Logistic models will be fitted and associated factors adjusted for if there is adequate data"},{"outcome_type":"secondary","measure":"Percentage of successful skin graft take or flap survival at Days 7, 14 and 30","time_frame":"30 Days","description":"Assessed by clinician visual assessment"},{"outcome_type":"secondary","measure":"Visual inspection of peri-wound skin condition","time_frame":"30 Days","description":"Visual inspection assessment (e.g., healthy, fragile, inflamed, erythema, bruising, eczematous, dry/flaky, macerated) at 7, 14 and 30 days"},{"outcome_type":"secondary","measure":"Visual Analog Scale (VAS) - pain","time_frame":"30 Days","description":"Level of subject pain during wear of the PICO 7 system, at dressing removal and at application assessed by VAS scale (pain intensity as none, mild, moderate, or severe) following 7 day therapy"},{"outcome_type":"secondary","measure":"Dressing wear time in days","time_frame":"30 Days","description":"Assessed through a combination of data from device microchip and CRF recorded data of any unplanned dressing change"}]}
{"nct_id":"NCT03715023","start_date":"2018-11-05","phase":"Phase 2","enrollment":5,"brief_title":"Anti-viral Effect of PC786 on RSV Infection on HSCT Recipients","official_title":"A Double Blind, Placebo-controlled Study to Assess the Anti-viral Effect, Safety and Tolerability of Inhaled PC786 for the Treatment of Acute Respiratory Syncytial Virus (RSV) Infection in Adult Hematopoietic Stem Cell Transplant Recipients","primary_completion_date":"2019-02-19","study_type":"Interventional","rec_status":"Terminated","completion_date":"2019-05-01","last_update":"2019-06-12","description":"This study tests the effects of an experimental drug PC786 in people infected with Respiratory Syncytial Virus (RSV). PC786 may be useful in treating patients infected with RSV as it works by interfering with the way the virus multiplies. PC786 is an inhaled medicine. Participants will be treated with SoC treatment (e.g. oral ribavirin and/or IV immunoglobulin), half of the participants will receive PC786 in addition and half will receive a placebo treatment. The study will take place at multiple sites in UK and will include approximately 30 participants. The maximum study duration will be about 4 weeks.","other_id":"PC_RSV_004","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Received an allogeneic or autologous hematopoietic stem cell transplant (HSCT) using\r\n             any conditioning regimen\r\n\r\n          -  Experienced new onset of at least one of the following respiratory symptoms 5 days\r\n             before study Day 1:\r\n\r\n        Nasal congestion or stuffiness, runny nose (rhinorrhoea), cough, or sore throat OR\r\n        Worsening of at least one of those symptoms, if symptoms are chronic OR Wheezing, sputum\r\n        production, pleuritic chest pain, increased respiratory rate, signs on chest auscultation,\r\n        hypoxia, increased supplemental oxygen requirement or new infiltrates on chest X-ray/CT\r\n\r\n          -  A positive RSV diagnostic test\r\n\r\n          -  Provided written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Is intubated and requires invasive ventilation\r\n\r\n          -  Has received any investigational RSV vaccine after HSCT, or has received any\r\n             monoclonal anti-RSV antibodies within 4 months or 5 half-lives before participation\r\n\r\n          -  Treatment with intravenous ribavirin\r\n\r\n          -  Positive for test for influenza or parainfluenza\r\n\r\n          -  Significant untreated bacteraemia or fungaemia\r\n\r\n          -  Significant untreated bacterial, fungal, or viral pneumonia\r\n\r\n          -  Precluded from participating as a result of treatment with another investigational\r\n             drug or participation in another clinical trial\r\n\r\n          -  Other disease or condition which would preclude the subject's participation in a\r\n             clinical trial\r\n\r\n          -  Is receiving an antiretroviral protease inhibitor\r\n\r\n          -  Has chronic, active hepatitis infection\r\n\r\n          -  Known alcohol or drug abuse\r\n      ","sponsor":"Pulmocide Ltd","sponsor_type":"Industry","conditions":"Respiratory Syncytial Virus Infections","interventions":[{"intervention_type":"Drug","name":"Drug: PC786","description":"PC786 suspension for inhalation"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo solution for inhalation"},{"intervention_type":"Drug","name":"Drug: SOC","description":"Standard treatment for RSV infection at study site"}],"outcomes":[{"outcome_type":"secondary","measure":"Maximum observed concentration (Cmax) of PC786 measured in plasma","time_frame":"Day 1, Pre-dose to 4 hours"},{"outcome_type":"secondary","measure":"Trough plasma concentration (Ctrough) of PC786","time_frame":"Days 2 and 3, Pre-dose"},{"outcome_type":"primary","measure":"RSV viral load measured in nasal secretions by reverse transcription quantitative PCR (RT-qPCR)","time_frame":"Day 1 to Day 3"},{"outcome_type":"primary","measure":"Proportion of participants reporting one or more treatment-emergent adverse event (TEAE)","time_frame":"Baseline to Day 28"},{"outcome_type":"primary","measure":"Proportion of participants who discontinue due to an adverse event","time_frame":"Baseline to Day 28"},{"outcome_type":"primary","measure":"Proportion of participants who meet the markedly abnormal criteria for 12-lead ECG assessment at lease once post dose","time_frame":"Baseline to Day 28"},{"outcome_type":"primary","measure":"Proportion of participants who meet the markedly abnormal criteria for vital signs assessment at lease once post dose","time_frame":"Baseline to Day 28"},{"outcome_type":"primary","measure":"Proportion of participants who meet the markedly abnormal criteria for safety laboratory assessment at lease once post dose","time_frame":"Day 1 to Day 28"},{"outcome_type":"primary","measure":"Proportion of participants who meet the markedly abnormal criteria for peak expiratory flow assessment at lease once post dose","time_frame":"Day 1 to Day 28"},{"outcome_type":"secondary","measure":"Average change in RSV load measured in nasal secretion","time_frame":"Day 1 to Day 7"},{"outcome_type":"secondary","measure":"Change in RSV load in nasal secretion","time_frame":"Baseline to Day 3"},{"outcome_type":"secondary","measure":"Change in RSV load in nasal secretion","time_frame":"Baseline to Day 7"},{"outcome_type":"secondary","measure":"Duration in viral shedding measured in nasal secretion","time_frame":"Day 1 to Day 28"},{"outcome_type":"secondary","measure":"Determination of nasal concentrations of PC786","time_frame":"Days 1, 2, 3, 7, 14 and 28"},{"outcome_type":"secondary","measure":"Area under the concentration versus time curve from time zero to time at 4 hours (AUC0-4) of PC786 in plasma","time_frame":"Day 1, Pre-dose to 4 hours"},{"outcome_type":"secondary","measure":"Last quantifiable concentration (Ct last) of PC786 measured in plasma","time_frame":"Day 1, and multiple timepoints to Day 28"},{"outcome_type":"secondary","measure":"Changes in RSV symptoms measured using a symptom diary card","time_frame":"Days 1, 2, 3, 4, 5, 6, 7, 14 and 28"},{"outcome_type":"secondary","measure":"Proportion of participants developing lower respiratory tract infection (LRTI) or pneumonia","time_frame":"Day 1 to 28"},{"outcome_type":"secondary","measure":"Proportion of participants progressing to invasive ventilation","time_frame":"Day 1 to 28"},{"outcome_type":"secondary","measure":"Trends in oxygen saturation index","time_frame":"Day 1 to Day 7"}]}
{"nct_id":"NCT03615495","start_date":"2018-11-05","enrollment":20,"brief_title":"Flourish Pediatric Esophageal Atresia","official_title":"Flourish Pediatric Esophageal Atresia Device Post-Approval Study (Flourish)","primary_completion_date":"2022-12-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2022-12-31","last_update":"2021-04-15","description":"This study is continued evaluation of the safety and probable benefit of the Flourish Pediatric Esophageal Atresia device through the Humanitarian Device Exemption (HDE) pathway.","other_id":"17-09","observational_model":"Case-Only","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","maximum_age":1,"population":"Pediatric patients with esophageal atresia without a tracheoesophageal fistula (TEF) or for\r\n        whom a concurrent TEF has been closed as a result of a prior procedure.","criteria":"\n        Inclusion Criterion:\r\n\r\n          -  Patient treated for esophageal atresia with Flourish device starting May 12, 2017\r\n      ","sponsor":"Cook Research Incorporated","sponsor_type":"Industry","conditions":"Esophageal Atresia|Digestive System Abnormalities|Esophageal Disorders Congenital","interventions":[{"intervention_type":"Device","name":"Device: Flourish Pediatric Esphogeal Atresia device","description":"The Flourish Pediatric Esophageal Atresia device consists of an esophageal catheter and a gastric catheter. Both catheters are equipped with an inner magnet catheter. When the esophageal and gastric catheters are aligned tip to tip, the magnets attract."}],"outcomes":[{"outcome_type":"primary","measure":"Rate of Adverse Events","time_frame":"2 years","description":"Adverse Events include: stricture at the anastomotic site leading to the need for dilation or surgery and peri-anastomotic leaks"}]}
{"nct_id":"NCT03206086","start_date":"2018-11-02","phase":"Phase 2","enrollment":35,"brief_title":"Eltrombopag for People With Fanconi Anemia","official_title":"Eltrombopag for Patients With Fanconi Anemia","primary_completion_date":"2026-05-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2030-05-01","last_update":"2021-09-01","description":"Background: Fanconi anemia is a genetic disease. Some people with it have reduced blood cell counts. This means their bone marrow no longer works properly. These people may need blood transfusions for anemia (low red blood cells) or low platelet counts or bleeding. Researchers want to see if a new drug will help people with this disease. Objective: To find out if a new drug, eltrombopag, is effective in people with Fanconi anemia. To know how long the drug needs to be given to improve blood counts. Eligibility: People at least 2 years old with Fanconi anemia with reduced blood cell counts. Design: Participants will be screened with blood and urine tests. They will repeat this before starting to take the study drug. Participants will take eltrombopag pills by mouth once a day for 24 weeks. They will be monitored closely for side effects. Participants will have blood tests every 2 weeks while on eltrombopag. Participants will visit NIH 3 months and 6 months after starting eltrombopag. At these visits, participants will: Answer questions about their medical history, how they are feeling, and their quality of life Have a physical exam Have blood and urine tests Have a bone marrow sample taken by needle from the hip. The area will be numbed. If participants blood cell counts improve, they might join the extended access part of the study. They will continue taking eltrombopag for 3 years and sign a different consent. After 24 weeks of treatment, if there is no improvement in blood cell counts, participants will stop taking eltrombopag. They will return for an optional follow-up visit that repeats the study visits. ...","other_id":"170121","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":2,"population":"","criteria":"\n        -  INCLUSION CRITERIA:\r\n\r\n          -  Confirmed diagnosis of Fanconi anemia. Diagnosis is confirmed by a biallelic mutation\r\n             in a known FANC gene and/or by positive chromosome breakage analysis in lymphocytes\r\n             and/or skin fibroblasts (for mosaicism).\r\n\r\n          -  One or more of the following three clinically-significant cytopenias: platelet count\r\n             less than or equal to 50,000/microliter or platelet-transfusion-dependence (requiring\r\n             at least 4 platelet transfusions in the 8 weeks prior to study entry, see definition\r\n             of platelet transfusion units at 8.2.1); neutrophil count less than 1000/ microliter;\r\n             hemoglobin less than 10 g/dL or red cell transfusion- dependence (requiring at least 4\r\n             transfusions of PRBCs (adult patient 4 units PRBC, pediatric patients at least\r\n             10ml/kg/transfusion) in the eight weeks prior to study entry.\r\n\r\n          -  Failed or declined treatment with androgens (danazol or oxymetholone).\r\n\r\n          -  Age greater than or equal to 2 years old.\r\n\r\n          -  Weight >10kg.\r\n\r\n        EXCLUSION CRITERIA:\r\n\r\n          -  Known active or uncontrolled infections not adequately responding to appropriate\r\n             therapy.\r\n\r\n          -  Evidence for MDS or AML as defined by WHO criteria.\r\n\r\n          -  Any cytogenetic abnormality associated with poor prognosis in FA, including gains of\r\n             chromosome 3q, deletions of chromosome 7, and complex cytogenetics (72, 73) identified\r\n             from bone marrow aspirate. Patients with known biallelic mutations in BRCA2 (FANCD1).\r\n\r\n          -  Active malignancy or likelihood of recurrence of malignancies within 12 months\r\n\r\n          -  Moribund status such that death within 7 to 10 days is likely. Comorbidities of such\r\n             severity that in the view of the investigator it would likely preclude the patient's\r\n             ability to tolerate eltrombopag.\r\n\r\n          -  Treatment with androgens (danazol or oxymetholone) less than 4 weeks prior to\r\n             initiating eltrombopag.\r\n\r\n          -  Creatinine > 2.5 times ULN\r\n\r\n          -  Direct Bilirubin > 3.0mg/dL, indicating congenital abnormalities in the bilirubin\r\n             level\r\n\r\n          -  SGOT (AST) or SGPT (ALT) >5 times the ULN normal\r\n\r\n          -  Known liver cirrhosis in severity that would preclude tolerability of eltrombopag as\r\n             evidenced by albumin < 35g/L.\r\n\r\n          -  Known immediate or delayed hypersensitivity to EPAG or its components.\r\n\r\n          -  Female subjects who are nursing or pregnant (positive serum or urine beta-human\r\n             chorionic gonadotrophin (b-hCG) pregnancy test) at screening or pre-dose on Day 1.\r\n\r\n          -  Women of child-bearing potential, defined as all women physiologically capable of\r\n             becoming pregnant, unless they are using highly effective methods of contraception\r\n             during dosing and for 30 days after the last dose of eltrompobag. Highly effective\r\n             contraception methods include:\r\n\r\n               -  Total abstinence (when this is in line with the preferred and usual lifestyle of\r\n                  the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal,\r\n                  post-ovulation methods) and withdrawal are not acceptable methods of\r\n                  contraception\r\n\r\n               -  Female sterilization (have had surgical bilateral oophorectomy with or without\r\n                  hysterectomy), total hysterectomy or tubal ligation at least six weeks before\r\n                  taking study treatment. In case of oophorectomy alone, only when the reproductive\r\n                  status of the woman has been confirmed by follow up hormone level assessment\r\n\r\n               -  Male sterilization (at least 6 months prior to screening). For female patients on\r\n                  the study the vasectomized male partner should be the sole partner for that\r\n                  patient.\r\n\r\n               -  Use of oral, injected or implanted hormonal methods of contraception or placement\r\n                  of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of\r\n                  hormonal contraception that have comparable efficacy (failure rate <1%), for\r\n                  example hormone vaginal ring or transdermal hormone contraception.\r\n\r\n               -  In case of use of oral contraception women should have been stable on the same\r\n                  pill for a minimum of 3 months before taking study treatment.\r\n\r\n               -  Women are considered post-menopausal and not of child bearing potential if they\r\n                  have had over 12 months of natural (spontaneous) amenorrhea with an appropriate\r\n                  clinical profile age appropriate (e.g. generally 40-59 years), history of\r\n                  vasomotor symptoms (e.g. hot flushes) in the absence of other medical\r\n                  justification or have had surgical bilateral oophorectomy (with or without\r\n                  hysterectomy), total hysterectomy or tubal ligation at least six weeks ago. In\r\n                  the case of oophorectomy alone, only when the reproductive status of the woman\r\n                  has been confirmed by follow up hormone level assessment is she considered not of\r\n                  child bearing potential.\r\n\r\n               -  Sexually active males unless they use a condom during intercourse while taking\r\n                  the study treatment and for 30 days after stopping study treatment and should not\r\n                  father a child in this period. A condom is required to be used also by\r\n                  vasectomized men as well as during intercourse with a male partner in order to\r\n                  prevent delivery of the drug via seminal fluid.\r\n\r\n          -  History of thromboembolic events.\r\n\r\n          -  Unable to take oral medication\r\n\r\n          -  History or current diagnosis of cardiac disease indicating significant risk of safety\r\n             for patients participating in the study such as uncontrolled or significant cardiac\r\n             disease, including any of the following:\r\n\r\n               -  Recent myocardial infarction (within last 6 months),\r\n\r\n               -  Uncontrolled congestive heart failure,\r\n\r\n               -  Unstable angina (within last 6 months),\r\n\r\n               -  Clinically significant (symptomatic) cardiac arrhythmias (e.g., sustained\r\n                  ventricular tachycardia, and clinically significant second or third degree AV\r\n                  block without a pacemaker.)\r\n\r\n               -  Long QT syndrome, family history of idiopathic sudden death, congenital long QT\r\n                  syndrome or additional risk factors for cardiac repolarization abnormality, as\r\n                  determined by the investigator.\r\n\r\n               -  Impaired cardiac function such as corrected QTc>450msec using Fridericia\r\n                  correction on the screening EKG, other clinically significant cardio-vascular\r\n                  disease (e.g. uncontrolled hypertension, history of labile hypertension), history\r\n                  of known structural abnormalities (e.g. cardiomyopathy).\r\n\r\n          -  History of HIV positivity.\r\n\r\n          -  History of alcohol/drug abuse.\r\n\r\n          -  Concurrent participation in an investigational study within 30 days prior to\r\n             enrollment or within 5-half-lives of the investigational product, whichever is longer.\r\n             Note: parallel enrollment in a disease registry is permitted.\r\n      ","sponsor":"National Heart, Lung, and Blood Institute (NHLBI)","sponsor_type":"NIH","conditions":"Fanconi Anemia","interventions":[{"intervention_type":"Drug","name":"Drug: Eltrombopag","description":"Daily dose - Non-Asian (greater than or equal to 12): 150 mg; Non-Asian (6-11): 75 mg; Non-Asian (4-5): 2.5 mg/kg; East Asian, South East Asian (greater than or equal to 12): 75 mg; East Asian, South East Asian (6-11): 37.5 mg; East Asian, South East Asian (4-5): 1.25 mg/kg"}],"outcomes":[{"outcome_type":"primary","measure":"Proportion of drug responders","time_frame":"6 months","description":"Peripheral blood platelet count increases to 20,000/ L above baseline at six months or stable platelet counts with transfusion independence, an increase in hemoglobin by > 1.5g/dL or a reduction in the units of PRBC transfusions by at least 50% during the eight consecutive weeks prior to response assessment -compared with the pretreatment transfusion number in the previous 8 weeks; at least a 100% increase in ANC, or an ANC increase >0.5 x 109/L; &amp; greater than or equal to 2- fold increase in normal marrow CD34+ cells by CD34 immunohistochemistry or flow cytometry, and/or greater than or equal to 2- fold increase in normal marrow cellularity as measured by standard stains (H&amp;E) of bone marrow biopsy /aspirate sections."},{"outcome_type":"primary","measure":"Toxicity profile","time_frame":"6 months","description":"Toxicity profile assessed at 6 months using the CTCAE criteria"},{"outcome_type":"secondary","measure":"Hematological responses","time_frame":"At 3 Months"},{"outcome_type":"secondary","measure":"Relapse","time_frame":"During 3 years of treatment"},{"outcome_type":"secondary","measure":"Clonal evolution","time_frame":"3 month,6 month (primary endpoint), every 6 month for 3 years after signing the extension part of the protocol."},{"outcome_type":"secondary","measure":"Toxicities with extended duration of therapy","time_frame":"3 month,6 month (primary endpoint), every 6 month for 3 years after signing the extension part of the protocol."},{"outcome_type":"secondary","measure":"Impact of treatment and treatment response on quality of life","time_frame":"3 month and 6 month"},{"outcome_type":"secondary","measure":"Evaluation of DNA repair activity in HSPCs (yH2AX Assay and comet assay)","time_frame":"At baseline, 3 and 6 months."},{"outcome_type":"secondary","measure":"Evaluation of global transcriptome in HSPCs (single cell RNA seq)","time_frame":"At baseline and 6 months"},{"outcome_type":"secondary","measure":"Serum cytokine profile, i.e. TNF alpha, IFNgamma, TPO","time_frame":"At baseline, 3 and 6 months"},{"outcome_type":"secondary","measure":"Multicolor flow cytometry of bone marrow cells","time_frame":"At baseline, 3 and 6 months"},{"outcome_type":"secondary","measure":"Impact of EPAG on other organ systems commonly involved in FA (e.g. skin lesions, endocrine dysfunction, and incidence of new head/neck, oropharyngeal, gastrointestinal, anogenital or skin cancers by clinical assessment)","time_frame":"At baseline, 3 and 6 months"}]}
{"nct_id":"NCT03268304","start_date":"2018-11-01","enrollment":0,"brief_title":"Feasibility of Two New Software Modules for the Rehabilitation of Patients With Neuromuscular Upper Limb Impairments","official_title":"Feasibility of Two Novel Interactive Software Modules for the Rehabilitation of Patients With Neuromuscular Upper Limb Impairments Using the YouGrabber Training System - the KAYO Study Protocol","primary_completion_date":"2020-04-01","study_type":"Observational","rec_status":"Withdrawn","completion_date":"2020-05-30","last_update":"2020-04-21","description":"Introduction: In the recent past, medical training systems using virtual reality (VR) have been introduced to neurorehabilitation to train motor function deficits in patients. The usage of VR-based training systems is based on the evidence of neuroplasticity, which is responsible for recovery of patients suffering from motor dysfunction. Such systems are increasingly used to encourage purposeful limb movements in a VR environment and its efficacy has been found comparable with conventional therapeutic intervention. VR training systems, e.g. the YouGrabber (YG), will increasingly also be used at home. Therefore, it is essential to integrate valid and reliable assessment tools to monitor the recovery process. Objectives: The aim of the clinical study is to evaluate the usability, feasibility and validity of the digital version of the ActionResearchArmTest (d-ARAT) using the YG system as a platform. Additionally, the feasibility and usability of the implementation of two rehabilitation measures that only recently became integral part of neurorehabilitation, e.g. Action Observation (AO) and Motor Imagery (MI), into the YG training software will be evaluated. Patients & methods: This observational study is designed as a single-arm trial for testing the assessment software including pre- to post rehabilitation comparison of a training involving AO and MI. Therefore, 75 adult patients with Parkinson's disease, MS, Stroke, traumatic brain injury or Guillain-Barr syndrome will be included. 30 out of the 75 patients will take part in the 4-week training on the enhanced VR-based system with a total of 16 training sessions of 45 min each. Primary outcomes will be the score on the System Usability Scale (SUS) and the ARAT as well as the d-ARAT scores. Secondary outcomes will be hand dexterity (Box-and-Block Test), upper limb activities of daily living (CAHAI) and quality of life (EQ-5D-5L). Hypothesis: The study was designed to evaluate the d-ARAT and the training software modules for the YG system. Currently AO and MI specific tasks are being integrated and the ARAT subscales will be implemented on the basis of the redesigned glove equipped with new sensors. The results are expected to give recommendations for necessary modifications. They might also contribute knowledge concerning the application of AO and MI tasks within VR training.","other_id":"KAYO","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"1. Patients will be recruited from the clinics' inpatient or outpatient departments by\r\n             physicians, therapists and nurses.\r\n\r\n          2. Patients will be recruited from the clinics' patient database. Datasets will be\r\n             screened for study selection criteria by the involved study personnel. If patients are\r\n             eligible, they will be sent a letter describing the study and including patient\r\n             information. If patients are interested in participating, they can contact the study\r\n             personnel in the clinic by phone or email.\r\n\r\n          3. Patients will be recruited via a study information flyer provided on the clinic's\r\n             homepage and through patient self-help groups. If patients are interested in\r\n             participating, they can contact the study personnel in the responsible clinic by phone\r\n             or email.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with motor function impairments of one or both upper limbs caused by\r\n             Parkinson's disease, MS, Stroke, traumatic brain injury or Guillain-Barr syndrome\r\n\r\n          -  Able to sit in a normal chair without armrests\r\n\r\n          -  Able to score at least one in the Box and Block Test (BBT)\r\n\r\n          -  Comprehend German\r\n\r\n          -  Informed Consent as documented by signature\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Wrist-, hand- or finger contractures or an unconsolidated upper limb fracture\r\n\r\n          -  Severe cognitive deficits: Mini-Mental-Status-Test (MMSE)  20\r\n\r\n          -  Severe spatial-visual disorders, e.g. severe visual neglect\r\n\r\n          -  History of epileptic seizures triggered by visual stimuli (e.g. television, video\r\n             games) within the last six months\r\n\r\n          -  Enrolment of the investigator, his/her family members, employees and other dependent\r\n             persons\r\n\r\n          -  Full score in the Chedoke Arm and Hand Activity Inventory (CAHAI) assessment\r\n\r\n          -  Brain pacemaker\r\n      ","sponsor":"Reha Rheinfelden","sponsor_type":"Other","conditions":"Stroke|Parkinson Disease|Traumatic Brain Injury|Guillain-Barre Syndrome","interventions":[{"intervention_type":"Other","name":"Other: VR-based training including AO and MI","description":"Virtual Reality-based training intervention including Action Observation and Motor Imagery using the YouGrabber training device"}],"outcomes":[{"outcome_type":"primary","measure":"SUS","time_frame":"15 weeks","description":"System Usability Scale questionnaire"},{"outcome_type":"secondary","measure":"BBT","time_frame":"17 weeks","description":"Box and Block Test"},{"outcome_type":"secondary","measure":"CAHAI","time_frame":"17 weeks","description":"Chedoke McMaster Arm and Hand Activity Inventory"},{"outcome_type":"secondary","measure":"EQ-5D-5L","time_frame":"17 weeks","description":"EuroQol five dimensions questionnaire with five-level scale"},{"outcome_type":"secondary","measure":"PGIC","time_frame":"11 weeks","description":"Patient Global Impression of change"},{"outcome_type":"primary","measure":"dARAT","time_frame":"17 weeks","description":"score on the digital ARAT"},{"outcome_type":"primary","measure":"cARAT","time_frame":"17 weeks","description":"Score on the conventional Action Research Arm Test"}]}
{"nct_id":"NCT03703830","start_date":"2018-11-01","phase":"N/A","enrollment":20,"brief_title":"tDCS Associated With Locomotor Training on Functional Mobility of Cerebellar Ataxia","official_title":"Effects of Cerebellar Transcranial Current Stimulation Associated With Locomotor Training on Functional Mobility of Subjects With Cerebellar Ataxia","primary_completion_date":"2020-01-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2020-02-28","last_update":"2019-07-30","description":"Cerebellar ataxia is a neurologic symptom caused by a damage or a dysfunction in cerebellum and results in loss of coordination, balance and postural control. This impairment could result in a reduction of walking speed, short and irregular steps and difficulty in coordinating between lower limbs. Pharmacological interventions are not able to modify ataxia gait pattern, therefore, new approaches to rehabilitate must be studied. Treadmill locomotor training (TLT) and cerebellar transcranial direct current stimulation (ctDCS) are physical therapy techniques able to module cerebellar afferences and modify positively ataxia gait pattern. However, there is no study involving the association of these two techniques. The purpose of this study is to evaluate the effects of ctDCS associated to TLT on functional mobility in subjects with cerebellar ataxia. A randomized, sham controlled, double blind clinical trial will be performed. The subjects will be randomly allocated into two groups: (i) ctDCS associated with TLT; (ii) ctDCS sham associated with TLT. The TLT will be performed with a speed and step length progression protocol for 25 minutes. The anodal ctDCS (2 mA, 25 minutes) or sham (2mA, 30 seconds) will be applied during TLT. The functional mobility will be the primary outcome and will be evaluated through timed up and go test (TUG). Ataxia' severity, balance and fall risky, will be the secondary outcomes and will be evaluated by the scale for the assessment and rating of ataxia (SARA), balance evaluation system test (miniBest) and TUG, respectively.","other_id":"Cerebellarataxia_ctDCS_LT","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Cerebellar ataxia\r\n\r\n          -  Ages: 18 to 65 years;\r\n\r\n          -  Gender: Both;\r\n\r\n          -  Score  3 and < 8 in subscore of gait in the Scale for the Assessment and Rating of\r\n             Ataxia\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Individuals with other neurological disorders, postural hypotension, vestibular,\r\n             visual, cardiovascular or musculoskeletal disorders that affect the performance of the\r\n             proposed tests;\r\n\r\n          -  Pacemaker;\r\n\r\n          -  History of seizures;\r\n\r\n          -  Metallic implants in the head or neck;\r\n\r\n          -  Medication change during the period of study\r\n      ","sponsor":"Universidade Federal de Pernambuco","sponsor_type":"Other","conditions":"Ataxia, Cerebellar","interventions":[{"intervention_type":"Device","name":"Device: Cerebellar transcranial direct current stimulation","description":"Cerebellar transcranial direct current stimulation (ctDCS) will be applied during 25 minutes at 2 mA of intensity. Anodal electrode will be positioned 1 cm below inion and cathodal electrode at right deltoid muscle."},{"intervention_type":"Other","name":"Other: Treadmill locomotor training","description":"The Treadmill Locomotor Training (TLT) will be performed through speed and step length progression protocol for 25 minutes and combined to ctDCS"},{"intervention_type":"Device","name":"Device: Sham Cerebellar transcranial direct current stimulation","description":"Sham Cerebellar transcranial direct current stimulation (ctDCS sham) will be applied during 30 seconds at 2 mA of intensity. Anodal electrode will be positioned 1 cm below inion and cathodal electrode at right deltoid muscle. However, subjects will keep the placement of electrodes for 25 minutes to ensure stimulation's masking."}],"outcomes":[{"outcome_type":"primary","measure":"Change in Functional mobility","time_frame":"Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day","description":"The evaluation of the functional mobility of individuals will be performed by the Timed Up and Go test. It will analyze the time spent by the individual to get up from a chair with arms, walk for three meters and return to the chair. Longer times to performe the Timed Up and Go test mean worse functional mobility."},{"outcome_type":"secondary","measure":"Change in Fall risk","time_frame":"Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day.","description":"The evaluation of the functional mobility of individuals will be performed by the Timed Up and Go test. It will analyze the time spent by the individual to get up from a chair with arms, walk for three meters and return to the chair. Longer time values and step numbers represent a greater risk of falls. Time greater than 10 seconds in the test means greater risk of falling."},{"outcome_type":"secondary","measure":"Change in Ataxia severity","time_frame":"Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day.","description":"The ataxia' severity will be assessed by the Scale for the Assessment and Rating of Ataxia (SARA). It consists of eight items (gait, stance, sitting, speech disturbance, finger chase, nose-finger test, fast alternating, hand movements, and heel-shin slide), where ranges from 0 to 40. Higher score mean more severe ataxia."},{"outcome_type":"secondary","measure":"Change in Balance","time_frame":"Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day.","description":"The balance of individuals will be assessed through the Balance Evaluation System Test (BESt), which comprises 14 items with a score of 0-2 each from 0 (worst) to 2 (best performance), used to assess dysfunction in balance and independence in life activities daily."},{"outcome_type":"secondary","measure":"Change in Patient global impression","time_frame":"Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day","description":"The patient's global impression is a questionnaire which the patient has to answer how the treatment changed his life daily activities. Patient will choose the best option that reflects their improvement in quality of life, from \"no change\" to \"much better with differences that have made all the difference\"."},{"outcome_type":"secondary","measure":"Adverse effects of ctDCS","time_frame":"25 minutes after the beginning of stimulation","description":"Brunoni's questionnaire will be used to ask the patient about some possible adverse effects related to stimulations. The patient will be asked always at the end of each stimulation (real or sham)."}]}
{"nct_id":"NCT03689959","start_date":"2018-11-01","phase":"N/A","enrollment":13,"brief_title":"Correction of Fixed Knee Flexion Deformity in Children Using Eight-plate Hemiepiphysiodesis","official_title":"Correction of Fixed Knee Flexion Deformity in Children Using Eight-plate Hemiepiphysiodesis","primary_completion_date":"2022-01-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-02-28","last_update":"2021-07-21","description":"The study aims to assess the effectiveness of hemiephysiodesis using eight plates in correction of fixed knee flexion deformities in children.","other_id":"UMIN000018950","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":4,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Fixed knee flexion deformity more than 10\r\n\r\n          -  Unilateral or bilateral cases\r\n\r\n          -  12 months or more predicted growth remaining\r\n\r\n          -  No response to non-operative treatment (physical therapy, bracing, casting);\r\n\r\n          -  Recurrent cases\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Dynamic deformities due to spasticity\r\n\r\n          -  Deformities responding to conservative treatment\r\n      ","sponsor":"Assiut University","sponsor_type":"Other","conditions":"Knee Deformity","interventions":[{"intervention_type":"Procedure","name":"Procedure: Eight plate hemiepiphysiodesis","description":"Patient is positioned in a classic supine position. Under fluoroscopic guidance and tourniquet hemostasis, the distal femoral physis is identified. Two 3-cm incisions are made, one on either side of the patella, centred at the level of the physis. The capsule and synovium are opened to visualize the sulcus and place the plates just outside the articular portion of the joint surface, medially and laterally. Care is taken not to damage the periosteum and a needle is inserted into the physis. The 8-plate, which has a central hole, is slipped over the needle and screws inserted. After wound closure, a soft dressing is used, and the patient is allowed to ambulate as tolerated."}],"outcomes":[{"outcome_type":"primary","measure":"Degree of flexion deformity","time_frame":"One year","description":"The angle between the anterior borders of thigh and leg measured clinically with a goniometer"},{"outcome_type":"secondary","measure":"Complications","time_frame":"One year","description":"Wound complications, metal failure"},{"outcome_type":"secondary","measure":"Rate of correction","time_frame":"One year","description":"Time needed for correction of deformity"}]}
{"nct_id":"NCT04461756","start_date":"2018-11-01","phase":"Phase 1","enrollment":12,"brief_title":"Safety and Pharmacokinetics of Vaped Cannabis in Healthy Volunteers","official_title":"A Phase I Exploratory Study to Assess the Pharmacokinetics of Single Inhaled Dose of Cannabis (Delta-9-Tetrahydrocannabinol / Cannabidiol) Administered by Vaporization Using a 4-Day Dose Titration In Healthy Male And Female Volunteers","primary_completion_date":"2018-11-24","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-11-24","last_update":"2020-07-10","description":"The primary objective of this study was to evaluate the pharmacokinetics (PK) of THC, 11-OH-THC and CBD following a single inhaled dose of PPP001 administered by vaporization. The secondary objective of this study was to determine the safety and tolerability of THC and CBD after a single inhaled dose of PPP001 administered by vaporization in healthy volunteers.","other_id":"PPP001-Ph1-03","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Body mass index within 21.0 to 32.0 kg/m2, inclusively\r\n\r\n          -  A light-, non- or ex-smoker of nicotine\r\n\r\n          -  A history of recreational cannabis use (at least 10 times in the last 5 years)\r\n\r\n          -  Consumed cannabis in the last 3 months before Day 1 of the study, but not within 1\r\n             month before Day 1 of the study\r\n\r\n          -  Presence of intact oral mucosa\r\n\r\n          -  Able to follow instructions at the training vaporizing session\r\n\r\n          -  Clinical laboratory values within the laboratory's stated normal range; if not within\r\n             this range, they must have been without clinical significance, as determined by an\r\n             investigator\r\n\r\n          -  No clinically significant diseases captured in the medical history or evidence of\r\n             clinically significant findings on the physical examination (including vital signs),\r\n             or ECG, as determined by an investigator\r\n      ","sponsor":"Tetra Bio-Pharma","sponsor_type":"Industry","conditions":"Healthy Volonteers","interventions":[{"intervention_type":"Drug","name":"Drug: PPP001","description":"inhalation (vape)"}],"outcomes":[{"outcome_type":"primary","measure":"Biochemistry test results [Safety and Tolerability]","time_frame":"over 5 days","description":"Number of subjects with alkaline phosphatase and alanine aminotransferase (ALT) increase"},{"outcome_type":"primary","measure":"Temperature [Safety and Tolerability]","time_frame":"over 5 days","description":"Oral temperature in Celsius"},{"outcome_type":"primary","measure":"Pulse rate [Safety and Tolerability]","time_frame":"over 5 days","description":"Pulse rate (in beats per minute)"},{"outcome_type":"primary","measure":"Assessment of adverse events [Safety and Tolerability]","time_frame":"over 5 days","description":"To evaluate treatment-related adverse events of PPP001"},{"outcome_type":"primary","measure":"Blood pressure [Safety and Tolerability]","time_frame":"over 5 days","description":"Blood pressure (systolic/diastolic blood pressure in mm Hg)"},{"outcome_type":"primary","measure":"Clinically significant ECG abnormalities [Safety and Tolerability]","time_frame":"over 5 days","description":"Number of subjects with clinically significant ECG abnormalities (measured with a 12-lead ECG)"},{"outcome_type":"primary","measure":"Plasma concentrations of delta-9-tetrahydrocannabinol produced by PPP001 were determined. (pharmacokinetics)","time_frame":"over 5 days"},{"outcome_type":"primary","measure":"Plasma concentrations of 11-OH-delta-9-tetrahydrocannabinol produced by PPP001 were determined. (pharmacokinetics)","time_frame":"over 5 days"},{"outcome_type":"primary","measure":"Plasma concentrations of cannabidiol produced by PPP001 were determined. (pharmacokinetics)","time_frame":"over 5 days"}]}
{"nct_id":"NCT03790007","start_date":"2018-11-01","phase":"Phase 4","enrollment":3,"brief_title":"COMPARISON OF INTRAOPERATIVE LOCAL ANESTHETIC APPLICATIONS IN POSTOPERATIVE PAIN MANAGEMENT IN LAPAROSCOPIC CHOLECYSTECTOMY PATIENTS","official_title":"COMPARISON OF INTRAOPERATIVE TRANSVERSUS ABDOMINIS PLANE BLOCK, LOCAL ANESTHESIA APPLICATION TO THE PORT SITES AND INTRAPERITONEAL LOCAL ANESTHETIC APPLICATIONS IN POSTOPERATIVE PAIN MANAGEMENT IN LAPAROSCOPIC CHOLECYSTECTOMY PATIENTS","primary_completion_date":"2020-12-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2021-03-01","last_update":"2021-03-23","description":"Since 1987, laparoscopic cholecystectomy has become the standard procedure for gallbladder stones and lesions. Complications due to improvements in laparoscopy and increased surgical experience have decreased day by day, but there is still a problem in terms of postoperative pain management. Several pain management procedures have been tried to combat pain after laparoscopic cholecystectomy. The aim of this study is to decrease the length of hospital stay, to increase the comfort of the patient and to reduce the cost of treatment. Local anesthetic injection to port locations, intraperitoneal periportal local anesthetic injection ,Transversus Abdominis Plane Blok and without any local anesthetic application to the control group compared to the group's analgesic efficiency and to reduce the amount of analgesics needed, shorten the length of hospital stay and improve patient comfort.","other_id":"ANIL ERGIN....","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","intervention_model_description":"3 types of local anesthetic applying method will be compared","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients over 18 years of age who were admitted to the general surgery department with\r\n             the diagnosis of cholelithiasis\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who need to undergo peroperative open cholecystectomy procedure.\r\n\r\n          -  Patients with local anesthetic or NSAID allergy\r\n\r\n          -  Patients in pregnancy\r\n\r\n          -  Patients who are breastfeeding\r\n\r\n          -  Patients with connective tissue disease\r\n\r\n          -  Patients with malignancy in postoperative gallbladder pathological examination and\r\n             patients with any malignancy diagnosis\r\n\r\n          -  Patients with renal impairment, where the effect of using Marcain is unknown\r\n\r\n          -  Cardiac disease\r\n\r\n          -  Patients with hepatic impairment\r\n      ","sponsor":"Fatih Sultan Mehmet Training and Research Hospital","sponsor_type":"Other","conditions":"Postoperative Pain","interventions":[{"intervention_type":"Drug","name":"Drug: Bupivacaine","description":"In our study this local anesthetic agent will be applied for postoperative pain relief"}],"outcomes":[{"outcome_type":"primary","measure":"Level of postoperative pain: visual analogue scale","time_frame":"24 hours","description":"the level of the pain will be assessed using the VAS ( visual analogue scale) which is a psychometric response scale and the patient has to indicate a position along a continuous line between two end-points (no pain and maximum pain) that best reflects the intensity of their pain. The pain measurements will be done at 1,2,4,6,12,24 hours. Test is easy to obtain, reliable, valid and can detect changes of over time"}]}
{"nct_id":"NCT03466762","start_date":"2018-11-01","enrollment":500,"brief_title":"Resilience and Quality of Life Among Cancer Survivors","official_title":"Resilience and Quality of Life of Head & Neck Cancer and Brain Tumor Survivors in Pakistan","primary_completion_date":"2019-06-30","study_type":"Observational","rec_status":"Completed","completion_date":"2019-06-30","last_update":"2020-01-09","description":"The main aim of this study is to evaluate the impact of head & neck cancer and brain tumors on lives of patients in Pakistan. To the best of the investigators knowledge this will be the first in-depth study to evaluate resilience and quality of life (QoL) among this group of patients. These patients encounter challenges as they battle to maintain optimistic outlook towards life. Resilience and QoL among them changes over time and may be modifiable towards increased well-being. Resilience and QoL are critical components during diagnosis, treatment, survivorship, and at the end of life. Hence, these are important traits for promoting positive psychological well-being. Through this study the investigators will be able to identify problems faced by such patients in our setting. the investigators will be able to plan appropriate interventions to improve a person's resiliency and quality of life, reduce depression and anxiety, and increase their satisfaction with life. This study is also aimed to inform healthcare providers and researchers regarding protective or risk characteristics for coping with cancer. Practices and resilience interventions may improve well-being and adherence to care guidelines. The objectives of our study are: Primary Objectives: - To determine resilience and quality of life scores after treatment separately for head & neck cancer and Brain tumor patients in Pakistan. - To evaluate important factors associated with resilience and quality of life after treatment separately for head & neck cancer and Brain tumor patients in Pakistan. Secondary Objective:  To examine the relationship between resilience and quality of life after treatment separately for head & neck cancer and Brain tumor patients in Pakistan. It will be an analytical cross sectional study design. The study will be conducted at the Aga Khan University Hospital, Karachi. Study participants will be men and women greater than 18 years, with brain tumors or head & neck cancer fulfilling the eligibility criteria. Approximately 250 patients will be recruiting with brain tumors and 250 with head & neck cancer. Validated tools will be used to measure resilience and QoL.","other_id":"5154-Sur-ERC-17","observational_model":"Other","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Men and women greater than 18 years, who have received treatment for brain tumor and head &\r\n        neck cancer, fulfilling the below eligibility criteria.","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Individual aged > 18 years both gender\r\n\r\n          2. Had received treatment at AKUH for head & neck cancer and/or brain tumor.\r\n\r\n          3. Pakistani national currently living in Pakistan.\r\n\r\n        Exclusion Criteria\r\n\r\n          1. Known cases of any physical and/or psychiatric illness (manic disorder, schizophrenia\r\n             etc.) confirmed by medical records will be excluded from the study as they may be on\r\n             medications, hence we may not get the true results.\r\n\r\n          2. Patients on anti-depressants prescribed by a psychiatrist.\r\n\r\n          3. Participant with terminal disease like renal failure and stroke will be excluded\r\n             because these diseases also have profound effect on quality of life and resilience.\r\n      ","sponsor":"Aga Khan University","sponsor_type":"Other","conditions":"Mental Health Wellness 1","interventions":[{"intervention_type":"Other","name":"Other: Non applicable","description":"Non applicable"}],"outcomes":[{"outcome_type":"primary","measure":"Resilience of head and neck cancer and Brain tumor survivors","time_frame":"April 2018-March 2019","description":"Resilience will be measured by Wagnild & Young's 14 Item A high score represents better resilience. The respondent's choice ranges from 1 (Strongly Disagree) to 7 (Strongly Agree). The scale uses total scores rather than scores of individual items."},{"outcome_type":"secondary","measure":"Quality of life of head and neck cancer and Brain tumor survivors","time_frame":"April 2018-March 2019","description":"Quality of life will be measured by European Organization of Research and Treatment Of Cancer tool general (EORTC QLQ-C30) AND European Organization of Research and Treatment Of head and Neck cancer (EORTC QLQ-H&N35) AND European Organization of Research and Treatment Of Brain tumor ( EORTC QLQ-BN20) All of the scales and single-item measures scores range from 0 to 100. A high scale score represents a higher response level."}]}
{"nct_id":"NCT03684473","start_date":"2018-10-31","phase":"N/A","enrollment":50,"brief_title":"An Online Trauma-informed Yoga Program for Young Adults With Symptoms of Posttraumatic Stress Disorder","official_title":"Evaluation of an Online Trauma-informed Yoga Program for Young Adults With Symptoms of Posttraumatic Stress Disorder: A Randomized Controlled Trial","primary_completion_date":"2019-12-15","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2020-04-15","last_update":"2019-07-12","description":"Post-traumatic stress disorder (PTSD), a chronic, debilitating condition, is a growing public health concern as the Canadian population has the highest PTSD prevalence worldwide (9.2%; 3.7 million people). PTSD is linked with other comorbid mental health disorders (e.g., depression) and increased risk of chronic disease (e.g., cardiovascular disease, obesity) which presents challenges as far as selection of the appropriate treatment approach. Adjunctive treatment approaches for PTSD that include somatic-sensory body awareness (e.g., mindfulness, yoga) have been shown to be viable treatment options to reduce stress-related symptoms and enhance emotion regulation. Online treatment delivery for mental health disorders demonstrate similar reductions in self-reported symptoms as face-to-face methods and emphasize accessibility, reduced costs, and enhanced appeal to certain demographic groups. A target population at risk of untreated PTSD symptoms that may benefit from an online treatment is young adults, 18-34 yrs., who have experienced childhood trauma. No known randomized controlled trial (RCT) has addressed the effectiveness of a brief (8-week) online trauma-informed yoga intervention using both self-report and objective measures. The purpose of this study is to evaluate the within- and between-group changes in self-reported PTSD symptoms and objectively measured biomarkers of autonomic regulation via pupil dilation and heart-rate-variability (HRV) following an 8-week prospective RCT design. It is hypothesized that clinically significant reductions of: 1) PTSD total symptom severity by 10% and 2) pupil dilation and; 3) increased HRV in the intervention group compared to non-significant findings in the wait-list controls. This is the first study to examine objective markers of autonomic regulation among an at-risk population using multiple novel technologies (e.g., Eye Tracking Glasses, HRV) and comparing two theoretically-linked measures (e.g., HRV, Pupillometry).","other_id":"2018-208","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":34,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Exposure to 1+ Lifetime Traumatic Events (LEC-5)\r\n\r\n          -  Minimum PTSD score of  12 on the Clinician Administered Posttraumatic Stress Scale\r\n             (CAPS-5)\r\n\r\n          -  18-34 years of age\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  current/ongoing trauma (e.g., current physical or sexual abuse) within the last month\r\n\r\n          -  current unstable medical condition\r\n\r\n          -  current active suicide risk/self-harm and/or drug addiction\r\n\r\n          -  current pregnancy/breastfeeding\r\n\r\n          -  current yoga attendance within the last month\r\n\r\n          -  no access to the internet\r\n      ","sponsor":"York University","sponsor_type":"Other","conditions":"Posttraumatic Stress Disorders|PTSD","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Yoga Intervention","description":"Online video instruction of yoga postures combined with breath awareness and meditation form the foundation of the intervention. The trauma-informed component of the program uses specific language, movement cues, teacher qualities, and physical assists. The yoga intervention will emphasize full choice and control of the participant through invitational language such as, \"when you are ready\", \"if you like\" before each body posture cue. Based on trauma-informed yoga best practices, a predictable foundation of yoga postures (with variations) will be followed in a consistent order each session to allow participants to anchor to the series."}],"outcomes":[{"outcome_type":"primary","measure":"Change in Posttraumatic Stress Symptoms on the Clinician Administered Posttraumatic Stress Scale for the Diagnostic and Statistical Manual of Mental Disorders (CAPS-5)","time_frame":"Baseline and 8-weeks","description":"A 30-item structured in-person interview with a trained clinician to confirm a current diagnosis of PTSD and associated symptoms based on a single index traumatic event (e.g., most recent, most severe). A single severity/distress score is calculated based on the frequency and intensity of a symptom using a 5-point scale (0 = absent/ no symptom; 1 = Mild/Symptom minimal; 2 = Moderate/Symptom Clearly Present; 3 = Severe/Symptom Pronounced; 4 = Extreme/Symptom is extreme/incapacitating). For a clinically significant symptom to be deemed present, a minimum frequency of twice per month or \"some of the time\" (approximately 20-30%) plus a minimum intensity of \"clearly present\" must be reported. Scores range from 0 to 80."},{"outcome_type":"secondary","measure":"Change in Heart Rate Variability","time_frame":"Baseline and 8-weeks","description":"Participants will undergo a 5-minute neutral stimulus, 5-minute emotional stimulus task, and 10-minute guided meditation protocol. Electrocardiogram (ECG) recordings will be collected using a 4-channel data acquisition system, which uses 2 adhesive electrodes applied to the chest and a ground electrode on the ankle. Frequency-based metrics represent respiratory-based modulation of the autonomic nervous system (ANS). The primary three spectral components for ECG recordings are very low frequency (VLF; 0.003-0.04 Hz), low frequency (LF; 0.04-0.15 Hz), and high frequency (HF; 0.15-0.4 Hz). Greater power in the HF band is considered to reflect respiratory sinus arrhythmia as it reflects HR variation attributed to parasympathetic (vagal) tone. Additionally, a ratio of LF to HF power will provide a marker of ANS regulation in all participants. A higher LF-HF ratio indicates \"sympathetic dominance\", whereas values closer to 0 reflect ANS balance."},{"outcome_type":"secondary","measure":"Change in Pupil Diameter","time_frame":"Baseline and 8-weeks","description":"Participants will wear specialised eye tracking glasses to obtain pupil dilation recordings. Accordingly, participants will be presented with a plain, neutral stimulus and asked to focus their eyes on a fixation cross on the computer. Baseline (BL) pupil diameter will be captured in the 500ms directly preceding the emotional stimulus. Participants will undergo an emotional stimulus (ES) task viewing standardized emotional images (e.g., happy, sad) on a computer screen followed by a guided 10-minute meditation (GM) phase. Average peak stimulus pupil dilation will be calculated during each phase (BL, ES, GM). Increased pupil dilation reflects sympathetic nervous system dominance."},{"outcome_type":"secondary","measure":"Change in Respiration Rate","time_frame":"Baseline and 8-weeks","description":"Participants will undergo a 5-minute neutral stimulus, 5-minute emotional stimulus task, and 10-minute guided meditation protocol. A respiratory belt transducer will be worn around the abdomen at the same time heart rate and pupil diameter are being measured. The respiratory belt transducer is measures changes in chest diameter resulting from breathing by producing a linear voltage proportional to changes in length and connects directly to a Pod (DIN) Port on the electrocardiogram machine. Breaths will be measured and recorded as the number of breaths per minute."},{"outcome_type":"other","measure":"Change in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36)","time_frame":"Baseline and 8-weeks","description":"The SF-36 is a self-report questionnaire that assesses eight subscales: physical function, social function, role limitations due to physical limitations, role limitations due to social/emotional problems, bodily pain, vitality, mental health perception, and general health perception. A single-item measure of comparative health is also included. A composite physical and mental health summary score are calculated using algorithms recommended by the developers. Response scales are based on five-level responses (e.g., 0 = poor; 4 = excellent) with the exception of item 3 (limitations to physical function) which is scored based on a three-level response (e.g., 0 = no, not limited at all; 3 = yes, limited a lot). The total score in each SF-36 subscale ranges between 0 and 100 with larger scores indicating a higher/better health-related quality of life"},{"outcome_type":"other","measure":"Change in Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders - Civilian Version (PCL-5)","time_frame":"Baseline and 8-weeks","description":"The PCL-5 is a standardised 20-item self-report scale for PTSD symptoms. Participants indicate how much they have been bothered by a symptom item listed over the past month using a five-point Likert scale ranging from 0 = Not at all to 4 = Extremely. The PCL-5 is easily scored by summing all of the items for a total symptom severity score ranging between 0 to 80. Clinically meaningful PTSD symptoms are present if items are rated as a minimum of 2 = \"Moderately\" or higher."},{"outcome_type":"other","measure":"Change in Beck Anxiety Inventory (BAI)","time_frame":"Baseline and 8-weeks","description":"The BAI is a 21-item self-report inventory to assess symptoms of anxiety within the last two weeks. Respondents rate how much each of the 21 symptoms bothered them in the past month on a four-point ordinal Likert scale from 0 = \"not at all\" to 3 = \"severely, it bothered me a lot\". Scoring for the BAI ranges from a minimum of 0 to a maximum of 63 based on summing the scores for all items. The following empirically supported cutoffs are followed for the interpretation of scores: 0-9 = normal/no anxiety, 10-18 = mild to moderate anxiety, 19-29 = moderate to severe anxiety, 30-63 = severe anxiety."},{"outcome_type":"other","measure":"Change in Beck Depression Index-II (BDI-II)","time_frame":"Baseline and 8-weeks","description":"Depression symptoms will be assessed using the BDI-II, a 21-item self-report survey. The BDI-II evaluates symptoms and attitudes related to depression using a four-level weighted Likert response scale ranging from 0 = not present to 3= severe. The participant is instructed to respond to items pertaining to how they were feeling in the past two weeks. Scoring for the BDI-II ranges from 0 to a maximum score of 63; empirically informed cutoff scores for severity of depression include the following: 0-13 = minimal, 14-19 = mild, 20-28 = moderate, 29-63 = severe."},{"outcome_type":"other","measure":"Change in Five Facet Mindfulness Questionnaire (FFMQ)","time_frame":"Baseline and 8-weeks","description":"Daily Mindfulness will be measured using the 39-item FFMQ. The FFMQ assesses changes in mindfulness tendencies (e.g., non-judgement of inner experience) before and after a mindfulness-based intervention. The FFMQ measures five mindfulness-based factors including non-reactivity, observing, describing, non-judgement, and acting with awareness. Item scores range on a five-level Likert scale of 1 = never or rarely true to 5 = very often or always true. The FFMQ is scored by summing all item responses and total scores range from 0 to 195, with higher scores indicating greater levels of mindfulness."}]}
{"nct_id":"NCT03641261","start_date":"2018-10-29","phase":"N/A","enrollment":42,"brief_title":"Therapeutic Education Using an Internet Application in Hereditary Ichthyosis","official_title":"Evaluation of the Feasibility and Effect of Therapeutic Education Sessions Using an Internet Application in Hereditary Ichthyosis","primary_completion_date":"2021-11-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-02-28","last_update":"2020-08-25","description":"The main purpose is to evaluate the feasibility (global use) of a therapeutic patient education program using a specific web application in patients with hereditary ichthyosis.","other_id":"RC31/16/8765","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":15,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patient with hereditary ichthyosis, according to the classification established during\r\n             the 2009 consensus conference\r\n\r\n          -  Who has given his informed consent form\r\n\r\n          -  Who is affiliated to a social security system\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patient who has already participated in a therapeutic patient education program for\r\n             the hereditary ichthyosis\r\n\r\n          -  Unable to connect or use a computer tool\r\n\r\n          -  Impossibility to be present at the only face-to-face session\r\n\r\n          -  Patient who is not available for the collective educational session\r\n\r\n          -  Patient with little or no motivation to follow a therapeutic patient education program\r\n             (motivation evaluated by the educational team by phone call before inclusion)\r\n\r\n          -  Patient not mastering the French language\r\n\r\n          -  Person under legal protection (guardianship, curators or safeguard of justice)\r\n      ","sponsor":"University Hospital, Toulouse","sponsor_type":"Other","conditions":"Ichthyosis","interventions":[{"intervention_type":"Other","name":"Other: Therapeutic patient education program","description":"WebIchtyose is a specific therapeutic patient education program for patients with hereditary Ichthyosis targeting the problems of each patient by means of a personalized follow-up and a constant interaction between the patient and the educational team"}],"outcomes":[{"outcome_type":"secondary","measure":"Fractional use in each domain (consultation)","time_frame":"6 months","description":"\"WebIchtyose\" application use time by the patient for the consultation of the \"Frequently Asked Questions\" area and of patient information documents made available on the application"},{"outcome_type":"secondary","measure":"Educational team acceptability","time_frame":"6 months","description":"Acceptability questionnaire to be completed by each member of the educational team"},{"outcome_type":"secondary","measure":"Attractiveness","time_frame":"6 months","description":"Application attractiveness questionnaire completed by the patient"},{"outcome_type":"secondary","measure":"Quality of life before and after treatment","time_frame":"Inclusion, 6 months and 9 months","description":"Quality of life questionnaire for hereditary ichthyosis (IQoL-32)"},{"outcome_type":"primary","measure":"Global use","time_frame":"6 months","description":"percentage of patients who have used the \"WebIchtyose\" application for at least 8 hours during 6 months"},{"outcome_type":"secondary","measure":"Fractional use in each domain (educational sessions)","time_frame":"6 months","description":"\"WebIchtyose\" application use time by the patient for group and individual educational sessions"},{"outcome_type":"secondary","measure":"Fractional use in each domain (continuous educational follow-up)","time_frame":"6 months","description":"\"WebIchtyose\" application use time by the patient for the continuous educational follow-up"},{"outcome_type":"secondary","measure":"Fractional use in each domain (questionnaires)","time_frame":"6 months","description":"\"WebIchtyose\" application use time by the patient for the filling of the questionnaires"},{"outcome_type":"secondary","measure":"Fractional use in each domain","time_frame":"6 months","description":"\"WebIchtyose\" application use time by the patient for group and individual educational sessions, the continuous educational follow-up, the consultation of the \"Frequently Asked Questions\" area and of patient information documents made available on the application"},{"outcome_type":"secondary","measure":"Difficulty of individual application registration","time_frame":"Baseline","description":"Difficulty of registration questionnaire completed for each patient jointly by the patient and the educational team at the end of the face-to-face inclusion visit"},{"outcome_type":"secondary","measure":"Difficulties of use in everyday life by the patient","time_frame":"6 months","description":"Questionnaire completed for each patient jointly by the patient at the end of the program"},{"outcome_type":"secondary","measure":"Number of exchanges","time_frame":"3 months and 5 months","description":"Number of exchanges necessary between the educational team and the patient to set a date for the conduct of the individual educational sessions"},{"outcome_type":"secondary","measure":"Response time","time_frame":"6 months","description":"Response time of the educational team following a request from the patient as part of the educational follow-up"},{"outcome_type":"secondary","measure":"Number of relaunches","time_frame":"2 months, 4 months and 6 months","description":"How many times the nurse relaunches the patient to obtain the assessment questionnaires"},{"outcome_type":"secondary","measure":"Number of non-received questionnaires","time_frame":"2 months, 4 months and 6 months","description":"Number of non-received questionnaires after relaunch"},{"outcome_type":"secondary","measure":"Number of lost to follow-up patients","time_frame":"9 months","description":"Number of lost to follow-up patients"},{"outcome_type":"secondary","measure":"Patient acceptability","time_frame":"6 months","description":"Acceptability questionnaire to be completed by the patient"},{"outcome_type":"secondary","measure":"Self-assessment of cutaneous severity","time_frame":"Inclusion and 6 months","description":"Self-assessment of cutaneous severity according to an analogic visual scale for pain, pruritus, erythema, squama"},{"outcome_type":"secondary","measure":"Knowledge about disease and treatments","time_frame":"Inclusion and 6 months","description":"Questionnaire of knowledge about disease and treatments"},{"outcome_type":"secondary","measure":"Self-care skills","time_frame":"Inclusion and 6 months","description":"Questionnaire of self-care skills"},{"outcome_type":"secondary","measure":"Self-esteem","time_frame":"Inclusion and 6 months","description":"Questionnaire about self-esteem: Rosenberg scale. For each item of the questionnaire, the modality answers are : 1 (totally disagree), 2 (quite disagree), 3 (quite agree) and 4 (totally disagree). The total score (/ 40) is calculated by adding the scores obtained for each item."},{"outcome_type":"secondary","measure":"Coping scale","time_frame":"Inclusion and 6 months","description":"Coping with health injuries and problem (Endler 1998). For each item of the questionnaire, the modality answers are: 1 (not at all), 2 (a little), 3 (moderately), 4 (often) and 5 (a lot).The total score (/ 160) is calculated by adding the scores obtained for each item."}]}
{"nct_id":"NCT03725761","start_date":"2018-10-24","phase":"Phase 2","enrollment":55,"brief_title":"IMMU-132 in Patients With Metastatic Castration-Resistant Prostate Cancer Progressing on Second Generation AR-Directed Therapy","official_title":"A Study to Evaluate the Safety and Efficacy of IMMU-132 (Sacituzumab Govitecan) in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Progressed on Second Generation AR-Directed Therapy","primary_completion_date":"2022-08-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2024-06-30","last_update":"2021-09-16","description":"This study will investigate the safety and efficacy of IMMU-132 in patients with metastatic castration-resistant prostate cancer progressing on abiraterone or enzalutamide.","other_id":"UW18043","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Documented histological or cytological evidence of adenocarcinoma of the prostate\r\n\r\n          -  Documented metastatic disease on bone scan and/or CT scans\r\n\r\n          -  Received enzalutamide, abiraterone, or apalutamide. Subjects who have received\r\n             combination enzalutamide/abiraterone or combination ARN-509/abiraterone as part of\r\n             ongoing clinical trials are allowed. Subjects who have received TAK-700 (Orteronel),\r\n             TOK-001 (Galeterone), or any other therapeutic investigational product directed\r\n             towards the AR or androgen biosynthesis are allowed. Prior treatment with\r\n             first-generation AR antagonists (i.e., bicalutamide, nilutamide, flutamide) before\r\n             second generation AR-directed therapy is allowed.\r\n\r\n          -  Demonstrated disease progression while on enzalutamide, apalutamide, and/or\r\n             abiraterone. Progressive disease is defined by one or more of the following:\r\n\r\n               -  A rise in PSA on two successive determinations at least one week apart and PSA\r\n                  level 2 ng/mL\r\n\r\n               -  Soft-tissue progression defined by RECIST 1.1\r\n\r\n               -  Bone disease progression defined by PCWG2 with 2 new lesions on bone scan\r\n\r\n          -  A minimum serum PSA level of 2 ng/mL that is rising based on the PCWG2 criteria\r\n\r\n          -  18 y ears of age\r\n\r\n          -  Castrate levels of testosterone (<50 ng/dL [1.74 nmol/L])\r\n\r\n          -  Undergone orchiectomy, or have been on LHRH agonists or antagonists, for at least 3\r\n             months prior to study treatment start. Subjects on LHRH agonists/antagonists must\r\n             remain on these agents for the duration of the study\r\n\r\n          -  ECOG Performance Status of 0-1 (Appendix A)\r\n\r\n          -  Normal organ function with acceptable initial laboratory values within 30 days of\r\n             study treatment start:\r\n\r\n               -  WBC 3000/l\r\n\r\n               -  ANC 1000/l\r\n\r\n               -  Platelet count 100,000/l\r\n\r\n               -  HGB 9 g/dL\r\n\r\n          -  Adequate hepatic function as evidenced by AST/ALT levels <3X the ULN and bilirubin\r\n             levels of <2.0 mg/dl.\r\n\r\n          -  Adequate renal function as evidenced by serum creatinine of <2.0 mg/dL\r\n\r\n          -  Able to provide written informed consent, or have a legal representative provide\r\n             written informed consent\r\n\r\n          -  Discontinued enzalutamide, apalutamide, or abiraterone 4 weeks prior to study drug\r\n             initiation\r\n\r\n          -  Subjects must have a previously-acquired biopsy from a metastatic site available\r\n\r\n          -  Subjects must be willing and able (in the opinion of the treating physician) to\r\n             undergo one research biopsy for the investigational component of this study\r\n\r\n          -  Subjects who have partners of child-bearing potential must be willing to use at least\r\n             two forms of effective birth control (one form must be a barrier method) during the\r\n             treatment period and for 90 days after last dose of IMMU-132. Subjects must also agree\r\n             to not donate sperm through 90 days following the last dose of IMMU-132.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Received prior cytotoxic chemotherapy for CRPC. Prior docetaxel for\r\n             castration-sensitive disease is permitted.\r\n\r\n          -  Received more than one second generation, FDA approved, AR-directed line of therapy:\r\n             i.e., sequential enzalutamide-abiraterone or abiraterone-enzalutamide will not be\r\n             allowed.\r\n\r\n          -  Completed sipuleucel-T (Provenge ) treatment within 30 days of study treatment start.\r\n\r\n          -  Received any therapeutic investigational agent within 2 weeks of study treatment\r\n             start.\r\n\r\n          -  Received palliative radiotherapy within 4 weeks of study treatment start.\r\n\r\n          -  Received herbal products or alternative therapies that may decrease PSA levels or that\r\n             may have hormonal anti-prostate cancer activity (e.g., saw palmetto, PC-SPES, PC-HOPE,\r\n             St. John's wort, selenium supplements, grape seed extract, etc.) within 4 weeks of\r\n             study treatment start or plans to initiate treatment with these products/alternative\r\n             therapies during the entire duration of the study.\r\n\r\n          -  Active CNS metastases from prostate cancer. Subjects with treated epidural disease are\r\n             eligible to enroll. Subjects with treated brain metastases can be included as long as\r\n             >4 weeks have elapsed since last treatment (radiotherapy or surgery) for brain\r\n             metastases, the subject is neurologically and radiographically stable, and is not\r\n             receiving corticosteroids for brain metastases. Subjects with untreated brain\r\n             metastases are excluded. Brain imaging (CT or MRI) is not required at baseline if\r\n             brain metastases are not clinically suspected.\r\n\r\n          -  A history within the last 3 years of another invasive malignancy (excluding\r\n             non-melanoma skin cancer).\r\n\r\n          -  A QTcF interval of >470 msec on the initial Screening ECG; if the Screening ECG QTcF\r\n             interval is >470 msec, then it may be repeated two more times, and if the mean QTcF of\r\n             the 3 ECGs is 470 msec, the subject may be enrolled.\r\n\r\n          -  A history of clinically significant cardiac arrhythmias including ventricular\r\n             tachycardia, ventricular fibrillation, torsades de pointes and second degree or third\r\n             degree atrioventricular heart block without a permanent pacemaker in place. Subjects\r\n             with resolved or rate-controlled atrial fibrillation/atrial flutter are allowed.\r\n\r\n          -  NYHA Class III or IV congestive heart failure, unstable angina, myocardial\r\n             infarction/acute coronary syndrome within the preceding 6 months.\r\n\r\n          -  Diabetes mellitus with more than 2 episodes of diabetic ketoacidosis in the 12 months\r\n             preceding study treatment start.\r\n\r\n          -  Inadequately controlled hypertension (defined as blood pressure >150mmHg systolic\r\n             and/or >100 mmHg diastolic despite antihypertensive medication) or any history of\r\n             hypertensive crisis or hypertensive encephalopathy.\r\n\r\n          -  History of loss of consciousness or transient ischemic attack within 12 months before\r\n             study treatment start.\r\n\r\n          -  Known active HIV, Hepatitis B, or Hepatitis C infections.\r\n\r\n          -  Any other medical, psychiatric, or social condition, including substance abuse, which\r\n             in the opinion of the Investigator would preclude safe participation in the study.\r\n      ","sponsor":"University of Wisconsin, Madison","sponsor_type":"Other","conditions":"Prostate Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: IMMU-132","description":"IMMU-132 is a novel Antibody Drug Conjugate (ADC) based on a humanized anti-Trop-2 antibody (hRS7) conjugated to SN-38 payload."}],"outcomes":[{"outcome_type":"primary","measure":"PSA response rate","time_frame":"up to 9 weeks","description":"Subjects who achieve ≥50% PSA decline at or before 9 weeks of therapy with IMMU-132 are considered to have responded. PSA responses will be analyzed by descriptive statistics and summarized in tabular format (frequency tables). The overall PSA response rate will be reported along with the corresponding 95% confidence interval which will be constructed using the Wilson score method."},{"outcome_type":"secondary","measure":"6-Month Median Progression Free Survival","time_frame":"6 months","description":"Proportion of subjects remaining alive and progression free (using PCWG2 criteria) 6 months from time of starting treatment as estimated by the Kaplan-Meier method."},{"outcome_type":"secondary","measure":"Median Progression Free Survival Rate","time_frame":"Up to 2 years from start of treatment","description":"The probability distribution of Progression Free Survival (PFS) will be estimated using the Kaplan-Meier method. The median will be estimated from this distribution. Subjects who have not died or progressed (using PCWG2 criteria) will be censored at the date of last assessment."},{"outcome_type":"secondary","measure":"Radiologic Response Rate","time_frame":"up to 2 years from start of treatment","description":"Number of subjects with reduction in tumor size compared to baseline."},{"outcome_type":"secondary","measure":"Median Overall Survival","time_frame":"Up to 2 years from start of treatment","description":"Overall Survival (OS) is the duration from start of treatment until death from any cause. The probability distribution of OS will be estimated using the Kaplan-Meier method. The median will be estimated from this distribution. Subjects who have not died will be censored at the date of last contact."},{"outcome_type":"secondary","measure":"Toxicity rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, etc.)","time_frame":"Up to 9 weeks from start of treatment","description":"Toxicities will be summarized by type and severity in tabular format. Toxicity rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, etc.) will be calculated and reported along the corresponding 95% confidence intervals. The 95% confidence intervals will be constructed using the Wilson score method."}]}
{"nct_id":"NCT03788993","start_date":"2018-10-23","phase":"N/A","enrollment":400,"brief_title":"Testing the Effectiveness of an Evening Blue-depleted Light Environment in an Acute Psychiatric Ward","official_title":"A Pragmatic Effectiveness Randomized Controlled Trial of Duration of Psychiatric Hospitalization in a Trans-diagnostic Sample of Patients With Acute Mental Illness Admitted to a Ward With Either Blue Depleted Evening Lighting or Normal Lighting Conditions.","primary_completion_date":"2019-11-29","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2021-11-01","last_update":"2021-09-09","description":"There is increasing recognition of the need to stabilize sleep-wake cycles in individuals with major mental disorders. As such, clinicians and researchers advocate for the use of interventions targeted at sleep and circadian dysrhythmias as an adjunct to the standard treatments offered for acute illness episodes of a broad range of diagnoses. To determine the trans-diagnostic generalizability of chronotherapy, the investigators will explore the benefits of admitting individuals with major mental disorders to an acute psychiatric inpatient unit where changes in light exposure are integrated into the therapeutic environment. A two-arm pragmatic effectiveness randomized controlled treatment trial, where individuals admitted for inpatient psychiatric care will be allocated to a ward with blue depleted evening light or to a ward with the same layout and facilities but lacking the new lighting technology. The trial will test whether the experimental lighting conditions offer any additional benefits beyond those associated with usual treatment in an acute psychiatric inpatient unit. The main objectives are to examine any differences between groups in the mean duration of hospitalization in days. Additional analyses will compare groups differences in sleep, functioning, symptoms, medication usage, and side-effects and whether length of stay is associated with stability of sleep-wake cycles and circadian rhythms. Given this unique research opportunity, ancillary investigations will determine any benefits according to diagnostic subgroups and potential drawbacks such as any adverse effects on the well-being of professionals working across both wards.","other_id":"2017/916","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"This is a single-centre, unblinded, two-arm, parallel-group, pragmatic effectiveness RCT of differences in the mean duration of acute psychiatric hospitalization in days for individuals exposed to experimental lighting compared with normal lighting conditions.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Individuals aged 18 years or older\r\n\r\n          -  Admitted to the acute inpatient unit at St. Olavs University Hospital, Department\r\n             stmarka, Trondheim, Norway during the inclusion period for the study.\r\n\r\n          -  Any patients who are re-admitted during the inclusion period for the study are\r\n             eligible for re-randomization.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Post-randomization, there are four potential reasons for exclusion from the RCT:\r\n\r\n          -  Lack of availability of rooms (as allocated at randomization): acute wards operate at\r\n             high levels of bed occupancy, so on some occasions there will be no rooms available in\r\n             the ward to which the individual is allocated (i.e. the randomization process cannot\r\n             be completed).\r\n\r\n          -  Clinical imperative: on some occasions senior medical or nursing professionals may\r\n             decide that it is clinically inappropriate to admit an individual to a vacant room in\r\n             the ward to which they are randomized. The most frequent reasons for this to occur are\r\n             clinical concerns about (a) how this admission would affect the case mix within the\r\n             ward (e.g. it may be inappropriate to locate all the patients with an acute episode of\r\n             mania in one ward, etc.) and/or (b) completing the randomization process may\r\n             compromise the safety, care and treatment of current inpatients or of the individual\r\n             being admitted (e.g. it may not be possible to provide the appropriate\r\n             staff-to-patient ratio required for optimal treatment if all individuals with higher\r\n             levels of need are located in one ward, etc.).\r\n\r\n          -  The individual is unwilling to give written informed consent at any time during their\r\n             admission (when approached according to the deferred consent procedure) or is unable\r\n             to give informed consent for the duration of the study (i.e. they remain persistently\r\n             and severely ill and/or lack mental capacity).\r\n\r\n          -  The consent procedure was incomplete: an individual may be discharged early or have an\r\n             unplanned discharge (e.g. discharge against medical advice) which may mean they were\r\n             not approached about study participation or they had only given verbal, but not\r\n             written consent.\r\n\r\n        Withdrawal criteria:\r\n\r\n        As randomization occurs at the point of admission, all exclusions de facto occur\r\n        post-randomization, so the criteria described above represent the main reasons for study\r\n        withdrawal.\r\n\r\n        Additional withdrawal criteria:\r\n\r\n          -  A patient will be withdrawn from the study if they are absent for >24 hours from the\r\n             ward to which they randomized (e.g. they may be transferred to a medical ward for\r\n             several days; the patient may request or the clinicians instigate transfer to another\r\n             ward; medical or nursing staff may decide the patient should be transferred to the\r\n             other ward at the unit because of patient need, case mix or staffing issues, etc.).\r\n\r\n          -  An individual can decline to participate at any stage of the study and/or a mental\r\n             health professional can recommend withdrawal of an inpatient from the RCT if they have\r\n             any clinical concerns regarding an individuals' participation (e.g. if there is a\r\n             belief that the patient has experienced an adverse event associated with exposure to\r\n             the blue-depleted light). In all instances a record will be kept of reasons for\r\n             withdrawal.\r\n      ","sponsor":"St. Olavs Hospital","sponsor_type":"Other","conditions":"Mental Disorder","interventions":[{"intervention_type":"Other","name":"Other: Blue-depleted evening light condition","description":"A 20-bedded ward with tunable light emitting diode (LED) lamps. At 18:00h the lighting undergoes a 30-minute transition during which the green and blue LEDs are dimmed to produce blue-depleted amber colored lighting. At 06:50h a new 10-minute transition changes the light color to ordinary indoor lighting. From 07:00h to 18:00h, there is ordinary indoor lighting (3000K colour temperature). The light intensity is dimmed to 20% of the maximum from 23:00h to 6:50h.\r\nBlue-blocking window filters are deployed also in the evening. All TV sets have permanent blue-blocking filters and individuals are provided with blue-blocking screens that can be attached to the front of personal electronic devices. If the patients leave the blue-depleted unit after 18:30 they are offered blue-blocking glasses to wear. The light spectrum in the ward was assessed prior to commencing the RCT and is well-matched to what has been shown in laboratory settings to minimally suppress melatonin."},{"intervention_type":"Other","name":"Other: Normal light condition","description":"The other half of the unit (20 patient rooms and their corresponding bathrooms and common areas) have ordinary indoor light installed (Glamox, Norway). This has a 3000K color temperature. The light is dimmed to 20% of max in the night, similar to the blue-depleted condition.\r\nThe light in the normal light condition and the blue-depleted light condition have similar levels of photopic lux throughout the 24h cycle, but different levels of melanopic lux between 1830h and 0700h."}],"outcomes":[{"outcome_type":"primary","measure":"Duration of admission","time_frame":"Recorded at the date of discharge (range from 0 to about 150 days).","description":"The primary outcome measure will be mean duration of admission per individual. The date and time of admission and of discharge will be extracted from the electronic records for the Intention To Treat (ITT) analyses. For the per-protocol analyses discharge will be the date and time the patient left the light environment the patient was randomized to and was subsequently away from the unit for more than 24 hours."},{"outcome_type":"secondary","measure":"Total Sleep Time","time_frame":"Daily throughout the admission (range form 0 to about 150 days).","description":"Individual sleep and activity patterns will be assessed using de-identified data collected via radar (Xethru sensors) installed in each room and the en suite bathroom. The sensor is a low-powered ultra-wideband radar that allows contact-free assessment sleep patterns and wakefulness with high accuracy compared to polysomnographic (PSG) recordings.\r\nEmploying best available scoring algorithms, raw data from daily recordings will be used to estimate total sleep time."},{"outcome_type":"secondary","measure":"Bed time","time_frame":"Recorded daily throughout the admission (range form 0 to about 150 days).","description":"Individual sleep and activity patterns will be assessed using de-identified data collected via radar (Xethru sensors) installed in each room and the en suite bathroom. The sensor is a low-powered ultra-wideband radar that allows contact-free assessment sleep patterns and wakefulness with high accuracy compared to polysomnographic (PSG) recordings.\r\nEmploying best available scoring algorithms, raw data from daily recordings will be used to estimate the time the patients went to bed (bed time)."},{"outcome_type":"secondary","measure":"Sleep onset","time_frame":"Recorded daily throughout the admission (range form 0 to about 150 days).","description":"Individual sleep and activity patterns will be assessed using de-identified data collected via radar (Xethru sensors) installed in each room and the en suite bathroom. The sensor is a low-powered ultra-wideband radar that allows contact-free assessment sleep patterns and wakefulness with high accuracy compared to polysomnographic (PSG) recordings.\r\nEmploying best available scoring algorithms, raw data from daily recordings will be used to estimate the time for sleep onset."},{"outcome_type":"secondary","measure":"Nocturnal awakenings","time_frame":"Recorded daily throughout the admission (range form 0 to about 150 days).","description":"Individual sleep and activity patterns will be assessed using de-identified data collected via radar (Xethru sensors) installed in each room and the en suite bathroom. The sensor is a low-powered ultra-wideband radar that allows contact-free assessment sleep patterns and wakefulness with high accuracy compared to polysomnographic (PSG) recordings.\r\nEmploying best available scoring algorithms, raw data from daily recordings will be used to estimate number of nocturnal awakenings."},{"outcome_type":"secondary","measure":"Wake after sleep onset","time_frame":"Recorded daily throughout the admission (range form 0 to about 150 days).","description":"Individual sleep and activity patterns will be assessed using de-identified data collected via radar (Xethru sensors) installed in each room and the en suite bathroom. The sensor is a low-powered ultra-wideband radar that allows contact-free assessment sleep patterns and wakefulness with high accuracy compared to polysomnographic (PSG) recordings.\r\nEmploying best available scoring algorithms, raw data from daily recordings will be used to estimate the time a patient is awake after initial sleep onset."},{"outcome_type":"secondary","measure":"Sleep offset","time_frame":"Recorded daily throughout the admission (range form 0 to about 150 days).","description":"Individual sleep and activity patterns will be assessed using de-identified data collected via radar (Xethru sensors) installed in each room and the en suite bathroom. The sensor is a low-powered ultra-wideband radar that allows contact-free assessment sleep patterns and wakefulness with high accuracy compared to polysomnographic (PSG) recordings.\r\nEmploying best available scoring algorithms, raw data from daily recordings will be used to estimate the time of final awakening called sleep offset."},{"outcome_type":"secondary","measure":"Level of clinical improvement","time_frame":"Recorded daily throughout admission and at the date of discharge (range from 0 to about 150 days).","description":"Clinical Global Impression, Improvement subscale (CGI-I): The investigators use the Improved version of the Clinical Global Improvement Scale (iCGI-I).28 Scores capture change over time with ratings ranging from -6 (maximum deterioration) to +6 (ideal improvement). The iCGI-I is used (a) to monitor day-to-day changes in mental state and functioning, and (b) to record overall change from admission to discharge."},{"outcome_type":"secondary","measure":"Level of illness severity","time_frame":"First 0-24 hours of admission, last 24 hours of admission","description":"Clinical Global Impression, Severity subscale (CGI-S): The CGI-S is a likert scale ranging from 1 (Normal, not at all ill) to 7 (Among the most extremely ill patients). These CGI-S ratings are benchmarked relative the total inpatient population (i.e. not according to diagnostic subgroups). It is scored on two occasions only: the morning after admission to the unit (based on observations for 0-24 hours since admission) and at discharge (based on information from the 24 hours preceding discharge)."},{"outcome_type":"secondary","measure":"Suicide risk","time_frame":"Daily throughout the admission (range from 0 to about 150 days)","description":"Suicide risk is assessed daily throughout the admission by a clinical psychologist or psychiatrist treating the patient. It is scored using one item assessing if the patient has elevated risk of suicide using a binary scale (yes/no) and one item assessing if there is need for continuous observation of the patient to reduce suicide risk (yes/no)."},{"outcome_type":"secondary","measure":"Aggressive behavior","time_frame":"One score will be made 2 hours into each shift, a total of three times per day, every day, while the patient is admitted (range from 0 to about 150 days)","description":"Risk of aggressive behaviour are assessed three times per 24 hours by nurses using the Brøset Violence Checklist (BVC). The BVC is a 6-item scale assessing the presence of six observable behaviours on a binary scale (1=present/0=not present). The BVC has with good psychometric properties and the sum score (range 0-6) indicates risk of violence (low=0, moderate =1-2, high > 2)."},{"outcome_type":"secondary","measure":"Aggressive incidents","time_frame":"Aggressive incidents are not recorded at pre-specified time points, but the time and date are recorded if they occur throughout the duration of admission (range 0 to about 150 days).","description":"Actual incidents of aggressive behaviour will be systematically recorded using the Staff Observation Aggression Scale-Revised (SOAS-R) and interventions employed will be recorded by the nurses. The items in the SOAS-R specifies the context of the aggressive incident and the severity of the aggressive incident on a 0 to 100 scale (0 = not severe, 100 = very severe)."},{"outcome_type":"secondary","measure":"Medication use","time_frame":"Daily throughout the admission (range from 0 to about 150 days)","description":"Daily doses and classes of medications (e.g. antipsychotics, mood stabilizers, benzodiazepines, etc.) or other treatments or interventions prescribed per individual during admission will be recorded."},{"outcome_type":"secondary","measure":"Admission status","time_frame":"Changes in admission status are not recorded at pre-specified times, but the time and date are recorded when they occur throughout the admission (range from 0 to about 150 days)","description":"If a patient is admitted involuntarily, the investigators will estimate the time until their status is reclassified as voluntary (as a marker of improved insight and mental capacity). Similarly change from voluntary to involuntary status and time to this reclassification will be recorded."},{"outcome_type":"secondary","measure":"Patient Satisfaction and Benefit","time_frame":"At the day of discharge (range 0 to about 150 days)","description":"Mean levels of patient satisfaction with an admission are routinely assessed using the standard patient satisfaction questionnaire completed at discharge. The questionnaire was developed by Norwegian Institute of Public Health, is used throughout the Norwegian Health Care system and consists of 10 items scored on a 5-point Likert scale (1=low satisfaction). Some items are relevant to examining experiences of the different lighting conditions, (e.g. was the treatment was tailored to your situation?) Also, there are items related to side effects (see below). A specific item assesses the perceived benefit of the admission (1 = no benefit, 5 = very large benefit)."},{"outcome_type":"secondary","measure":"Side effects of the light environment","time_frame":"At the day of discharge (range 0 to about 150 days)","description":"The frequency of any side effects or adverse events experienced by individuals admitted to each lighting condition will be examined. The assessment comprises of the Headache and Eye Strain Scale (HES) supplement by additional items developed specifically for this trial and setting (and incorporated into the satisfaction questionnaire), 22 items in total. The HES assesses eight symptoms each of which is rated on a 4-point scale (ranging from absent = 0, to severe = 3) and is sensitive to exposure to different lighting conditions. Study participants are asked to rate any HES symptoms experienced during the course of admission and 14 further items that may represent side effects of acute psychiatric treatment (e.g. dizziness, gastro-intestinal disturbances, daytime sleepiness, poor sleep quality, and restlessness, etc.) that will also be rated using the same 4-point scale. Range of scores is 0 to 66 points."},{"outcome_type":"secondary","measure":"Adverse effects of the light environment","time_frame":"Adverse effects are not recorded at pre specified times, but the time and date are recorded when they occur throughout the admission (range 0 to about 150 days)","description":"To capture any putative adverse events experienced during the admission the investigators will record any serious or untoward incidents (such as non-accidental and accidental deaths, near fatal events, severe violence, etc.). Also, the investigators will note if any patients are transferred out of the blue-depleted light environment because clinical opinion suggests that it may be having a detrimental effect on the individual."}]}
{"nct_id":"NCT03604263","start_date":"2018-10-18","phase":"N/A","enrollment":17,"brief_title":"ArcticLine Feasibility Study","official_title":"ArcticLine Feasibility Study","primary_completion_date":"2019-11-18","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-11-18","last_update":"2020-05-20","description":"The purpose of the ArcticLine Feasibility Study is to collect preliminary safety and effectiveness data on the ArcticLine Catheter.","other_id":"MDT16015","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Device Feasibility","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Documentation of symptomatic persistent AF:\r\n\r\n               -  Defined as having a continuous episode that is sustained beyond 7 days documented\r\n                  via consecutive ECG recordings, or\r\n\r\n               -  Defined as having a continuous episode that is sustained beyond 7 days documented\r\n                  by an ECG recording and one doctor note indicating the patient had symptoms\r\n                  consistent with AF\r\n\r\n          -  Age 18 through 80 years old\r\n\r\n          -  Failure or intolerance of at least one Class I or III antiarrhythmic drug\r\n\r\n          -  Subject is able and willing to consent to participate in the study and will commit to\r\n             completion of all follow-up requirements\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Longstanding persistent AF, defined as continuous AF greater than 12 month duration\r\n\r\n          -  Left atrial diameter greater than 5.0 cm\r\n\r\n          -  Active systemic infection\r\n\r\n          -  History of thromboembolic event within the past 6 months or evidence of intracardiac\r\n             thrombus at the time of the procedure\r\n\r\n          -  Prior left atrial ablation attempt, with exception of:\r\n\r\n               -  Any pulmonary vein isolation attempt to treat AF, or\r\n\r\n               -  Successful ablation to treat Wolff-Parkinson White syndrome\r\n\r\n          -  History of left atrial tachycardia\r\n\r\n          -  History of cardiac ablation within 90 days of planned clinical study procedure\r\n\r\n          -  Planned concomitant ventricular ablation\r\n\r\n          -  Cryoglobulinemia\r\n\r\n          -  Structural heart disease of clinical significance including:\r\n\r\n               -  NYHA Class IV Heart Failure\r\n\r\n               -  Diagnosed with NYHA Class III Heart Failure for more than six months at time of\r\n                  the study ablation procedure\r\n\r\n               -  LVEF less than 35%\r\n\r\n               -  Any cardiac surgery (e.g. CABG) within 3 months of the ablation procedure\r\n\r\n               -  Any mechanical heart valve, prior aortic or tricuspid valve replacement (e.g.\r\n                  valvotomy, valve replacement), or tricuspid valve repair\r\n\r\n               -  Severe mitral valve regurgitation or stenosis\r\n\r\n               -  Significant congenital anomaly or anatomy unable to accommodate device\r\n\r\n          -  Prior surgical maze procedure\r\n\r\n          -  Unstable angina\r\n\r\n          -  Myocardial infarction within 3 months of the ablation procedure\r\n\r\n          -  Presence of primum or secundum atrial septal defect\r\n\r\n          -  Anomalous pulmonary venous return\r\n\r\n          -  Prior surgery for congenital heart disease, including atrial septal defect repair\r\n\r\n          -  Hypertrophic cardiomyopathy with LV septal wall thickness >1.5 cm\r\n\r\n          -  Uncontrolled hyperthyroidism\r\n\r\n          -  Thrombocytosis, thrombocytopenia (including history of heparin-induced\r\n             thrombocytopenia)\r\n\r\n          -  Severe comorbidity or poor general physical/mental health that, in the opinion of the\r\n             investigator, will not allow the subject to be a good study candidate\r\n\r\n          -  History of blood clotting or bleeding abnormalities\r\n\r\n          -  Contraindication to all anticoagulation (e.g. novel oral anticoagulants, heparin or\r\n             warfarin)\r\n\r\n          -  Pregnant, nursing or planning to become pregnant during study duration\r\n\r\n          -  Enrollment in another clinical trial without prior approval from Medtronic\r\n\r\n          -  Presence or use of left atrial appendage closure device\r\n\r\n          -  Presence of or planned implantation of a pacemaker, implantable cardiac defibrillator,\r\n             implantable loop recorder or cardiac resynchronization device with permanent lead\r\n             placement\r\n\r\n          -  Pre-existing hemidiaphragmatic paralysis\r\n\r\n          -  Life expectancy less than one year\r\n\r\n          -  Known drug or alcohol dependency\r\n\r\n          -  Existing pulmonary vein stent(s)\r\n      ","sponsor":"Medtronic Cardiac Rhythm and Heart Failure","sponsor_type":"Industry","conditions":"Atrial Fibrillation|Atrial Flutter","interventions":[{"intervention_type":"Device","name":"Device: ArcticLine Cardiac Cryoablation Catheter","description":"Cryoablation"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants With Primary Safety Events With an Onset Date Within 7 Days Post-procedure.","time_frame":"7 days","description":"A primary safety event is defined as:\r\nAn ArcticLine Catheter-related or ArcticLine cryoablation procedure-related SAE with an onset date within 7 days post-procedure (except as noted below), as adjudicated by the Clinical Events Committee (CEC), described as follows:\r\nAtrioesophageal fistula*\r\n* Includes atrioesophageal fistula with an onset date at any time after the study cryoablation procedure and is adjudicated by the CEC as either ArcticLine Catheter-related or ArcticLine cryoablation procedure-related.\r\nCardiac perforation/tamponade\r\nCerebrovascular accident\r\nDeath\r\nEsophageal injury\r\nMajor bleeding\r\nMyocardial infarction\r\nPericarditis\r\nPhrenic nerve injury (ongoing at hospital discharge)\r\nTransient ischemic attack\r\nVagal nerve injury resulting in esophageal dysmotility or gastroparesis\r\nVascular access complications"}]}
{"nct_id":"NCT03766646","start_date":"2018-10-18","phase":"N/A","enrollment":34,"brief_title":"Preoxygenation With Optiflow - the Effect of Speech on Lung Oxygenation.","official_title":"Preoxygenation With High Flow Nasal Oxygenation Using Optiflow - Does Speech Have an Effect on The End Tidal Oxygen Achieved When Compared to Closed Mouth Nasal Breathing?","primary_completion_date":"2018-11-16","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-11-16","last_update":"2020-10-30","description":"If a patient speaks during the process of preoxygenation with high-flow nasal oxygen via the Optiflow system, is the efficacy reduced as measured by end-tidal lung oxygen content?","other_id":"RHM CR10369","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"None (Open Label)","intervention_model_description":"Patients were assigned to either the 'Speech' arm or 'Non-speech' arm of the study","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  BMI 18-35, ASA category 1 or 2\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Inability to read/ follow instructions, Heavily sedated\r\n      ","sponsor":"University Hospital Southampton NHS Foundation Trust","sponsor_type":"Other","conditions":"Unrecognized Condition","interventions":[{"intervention_type":"Device","name":"Device: Optiflow","description":"45l.min oxygen"}],"outcomes":[{"outcome_type":"primary","measure":"End Tidal Oxygen Fraction","time_frame":"At the end of 3 minutes preoxygenation","description":"Oxygen fraction in first expired breath post preoxygenation"}]}
{"nct_id":"NCT03720418","start_date":"2018-10-17","phase":"Phase 1/Phase 2","enrollment":30,"brief_title":"Study of OXB-102 (AXO-Lenti-PD) in Patients With Bilateral, Idiopathic Parkinson's Disease","official_title":"A Phase I/II Safety and Dose Evaluation Study of OXB-102 (AXO-Lenti-PD) in Patients With Bilateral Idiopathic Parkinson's Disease (SUNRISE-PD)","primary_completion_date":"2022-06-30","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2031-12-31","last_update":"2021-01-29","description":"This study consists of two parts. Part A will evaluate the safety and tolerability of multiple doses of OXB-102 (AXO-Lenti-PD) in participants with Parkinson's disease. Part B will assess the safety and efficacy of the selected dose of OXB-102 in participants with Parkinson's disease.","other_id":"OXB-102-01","allocation":"Randomized","intervention_model":"Sequential Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":30,"maximum_age":70,"population":"","criteria":"\n        Key Inclusion Criteria:\r\n\r\n          1. Diagnosed with bilateral idiopathic PD\r\n\r\n          2. Males/females between 30 and 70 years at the time of surgery\r\n\r\n          3. Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) score of between 30 and 60\r\n             in the \"OFF\" medication state\r\n\r\n          4. Presence of motor fluctuations and/or dyskinetic movement\r\n\r\n          5. Candidate for surgical intervention\r\n\r\n          6. Hoehn and Yahr (H&Y) Stage 3 or 4 in the \"OFF\" medication state\r\n\r\n          7. Stable dosing of PD medication, including L-DOPA, for four weeks prior to screening\r\n             with Levodopa equivalent daily dose (LEDD) of at least 900 mg\r\n\r\n        Key Exclusion Criteria:\r\n\r\n          1. History of psychosis or current treatment with dopamine blocking agents and prior\r\n             regular exposure to antipsychotic agents\r\n\r\n          2. History of stereotactic or other surgery for the treatment of PD, including Deep Brain\r\n             Stimulation (DBS)\r\n\r\n          3. Participation in a prior cell or gene transfer therapy study\r\n\r\n          4. Contraindications to use of anaesthesia\r\n\r\n          5. Current or anticipated treatment with anticoagulant therapy or the use of\r\n             anticoagulation therapy that cannot be temporarily stopped around the time of surgery\r\n\r\n          6. Diagnosis of multiple system atrophy\r\n\r\n          7. Abnormal MRI findings such as mega cisterna, septum pellucidum, signs of severe\r\n             cortical or subcortical atrophy, brain tumours, vascular diseases, trauma or\r\n             arteriovenous malformations\r\n\r\n          8. Presence of dementia\r\n      ","sponsor":"Sio Gene Therapies","sponsor_type":"Industry","conditions":"Parkinson Disease","interventions":[{"intervention_type":"Drug","name":"Drug: OXB-102","description":"Neurosurgical delivery of OXB-102 (gene therapy) to the putamen"},{"intervention_type":"Other","name":"Other: Imitation Surgical Procedure (ISP)","description":"Participants randomized to the control group in Part B will receive an ISP"}],"outcomes":[{"outcome_type":"primary","measure":"Safety of OXB-102 as measured by incidence of treatment emergent adverse events and serious adverse events","time_frame":"3 months timepoint","description":"Treatment emergent adverse events and serious adverse events will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, for severity"},{"outcome_type":"primary","measure":"Safety of OXB-102 as measured by changes in clinical laboratory analysis","time_frame":"3 months timepoint","description":"Number of clinically significant changes in clinical laboratory analysis"},{"outcome_type":"primary","measure":"Safety of OXB-102 as measured by changes in vital signs","time_frame":"3 months timepoint","description":"Number of clinically significant changes in vital signs"},{"outcome_type":"primary","measure":"Safety of OXB-102 as measured by changes in brain MRI findings","time_frame":"3 months timepoint","description":"Number of clinically significant changes in brain MRI findings"},{"outcome_type":"primary","measure":"Safety of OXB-102 as measured by changes in physical examination","time_frame":"3 months timepoint","description":"Number of clinically significant changes in physical examination"},{"outcome_type":"secondary","measure":"Change in Unified Parkinson's Disease Rating Scale (UPDRS) scores defined in \"OFF\" and \"ON\" medication states","time_frame":"Baseline to 6 months"},{"outcome_type":"secondary","measure":"Change in \"OFF\" time during waking day compared to baseline as assessed by participant diaries","time_frame":"Baseline to 6 months"},{"outcome_type":"secondary","measure":"Change in dyskinesia rating scale score","time_frame":"Baseline to 6 months"}]}
{"nct_id":"NCT03445260","start_date":"2018-10-17","phase":"N/A","enrollment":73,"brief_title":"PeRioperative Optimization With Nutritional Supplements for Patients Undergoing GastRointEStinal Surgery for Cancer","official_title":"PeRioperative Optimization With Nutritional Supplements in Patients Undergoing GastRointEStinal Surgery for Cancer (PROGRESS): A Randomized Placebo Controlled Feasibility Study.","primary_completion_date":"2020-07-22","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-08-30","last_update":"2021-09-02","description":"This is a single-center randomized, placebo-controlled, double-blind feasibility study comparing the intervention of perioperative nutritional supplements (immunomodulation, carbohydrate loading, and protein isolate) with an identical placebo for each solution in patients with gastrointestinal cancer undergoing surgery. Eligible and consenting patients will be randomly allocated to receive the intervention or placebo in a 1:1 ratio. This study will assess the feasibility of a large, multi-centre trial by establishing the feasibility of randomization to intervention or placebo. This study will be conducted at the Juravinski Hospital and will enroll 100 patients over 18 months. The study intervention includes three perioperative nutritional supplements: (1) a protein supplement administered 3 times a day for 30 days before surgery, (2) a sugar-based supplement administered the day prior to and the day of surgery, and (3) a formulated liquid diet containing arginine, RNA, proteins and omega-6 fatty acids (referred to as immunonutrition for the purposes of this study) administered for 5 days prior to and 5 days after surgery. The primary outcome for each eligible patient is defined as being randomized to intervention or placebo. The criteria for success of this study is defined as the proportion of eligible patients randomized as  60%. If the estimated proportion is <40%, the trial will be considered not feasible. If the proportion is between 40%-59%, the trial will be considered feasible with modifications to improve enrolment. Other secondary objectives include compliance with study intervention, estimating differences in postoperative complications, length of hospital stay, and quality of life between groups.","other_id":"3988","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Men and women 18 years of age or older\r\n\r\n          -  Diagnosed with a resectable type of gastrointestinal cancer (e.g. cancers of the\r\n             gallbladder, liver, pancreas, stomach, small intestine, colon and rectum) for which an\r\n             elective operation is planned (resection vs. palliative procedure).\r\n\r\n          -  Patients with distant metastasis are eligible for the study.\r\n\r\n          -  Patients who are lactose intolerant are also eligible for the study because the amount\r\n             of lactose in ISOlution and PreCovery is minimal (trace).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Malabsorption syndrome (e.g. chronic pancreatitis)\r\n\r\n          -  Cannot tolerate oral intake (e.g. gastric outlet obstruction or delayed gastric\r\n             emptying)\r\n\r\n          -  Organ failure (liver, kidney); end stage liver disease with a Child Pugh Score  B or\r\n             end stage renal disease defined as stages 3 and 4 with a glomerular filtration rate\r\n             between 30-59 for stage 3 and 15-29 for stage 4.\r\n\r\n          -  Inflammatory diseases such as rheumatoid arthritis, systemic lupus erythematous,\r\n             Crohn's disease and ulcerative colitis\r\n\r\n          -  Patients currently on steroids\r\n\r\n          -  Poorly controlled type 1 or 2 diabetes mellitus\r\n\r\n          -  Female patients who are pregnant and/or lactating\r\n\r\n          -  Galactosemia\r\n\r\n          -  Ongoing infection.\r\n      ","sponsor":"Hamilton Health Sciences Corporation","sponsor_type":"Other","conditions":"Gastrointestinal Cancer","interventions":[{"intervention_type":"Other","name":"Other: Nutritional Supplements","description":"PreCovery is a carbohydrate loading nutritional supplement, INergy FLD is an immunonutrition formulated liquid diet, and ISOlution is a protein supplement."},{"intervention_type":"Other","name":"Other: Placebo","description":"Each placebo is composed of a collagen-based filler with exactly the same taste and texture as the intervention."}],"outcomes":[{"outcome_type":"secondary","measure":"Length of Hospital Stay","time_frame":"1 month after index surgery","description":"Will be determined for each patient."},{"outcome_type":"primary","measure":"The number of patients randomized to the study","time_frame":"21 months","description":"Feasibility of this study will be determined by the number of eligible patients randomized to intervention or placebo."},{"outcome_type":"secondary","measure":"The number of patients who comply with the study intervention regimen","time_frame":"30 days before index surgery, and up to 5 days after index surgery","description":"Compliance will be defined as intake of at least 70% of study intervention regimen."},{"outcome_type":"secondary","measure":"Overall Complications","time_frame":"3 months after index surgery","description":"Occurrence of any postoperative complication (major or minor) from surgery following each patient's hospital stay and up to 90 days from the initial operation. Occurrence of any postoperative infections will also be calculated."},{"outcome_type":"secondary","measure":"Comprehensive Complication Index","time_frame":"3 months after index surgery","description":"At 90 days from the index operation will be determined for each patient. This index can be calculated for each patient using the online calculator www.assessurgery.com25 following the grading of each postoperative complication according to Clavien-Dindo."},{"outcome_type":"secondary","measure":"Quality of Life (QoL) - EORTC-QLQ-C Instrument","time_frame":"Baseline, 1 month, and 3 months after index surgery","description":"The global health related QoL at baseline, 1 and 3 months following randomization measured using the EORTC-QLQ-C instrument."},{"outcome_type":"secondary","measure":"Quality of Life (QoL) - FACT-G Scale","time_frame":"Baseline, 1 month, and 3 months after index surgery","description":"The global health related QoL at baseline, 1 and 3 months following randomization measured using the FACT-G scale."}]}
{"nct_id":"NCT03730337","start_date":"2018-10-17","phase":"Phase 1","enrollment":84,"brief_title":"Phase 1 Study of ONO-7475 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors","official_title":"Open-label, Uncontrolled, Dose-escalation Study of ONO-7475 Given as Monotherapy and Combinations With ONO-4538 in Patients With Advanced or Metastatic Solid Tumors","primary_completion_date":"2023-04-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-04-30","last_update":"2021-05-24","description":"To evaluate the tolerability and safety of ONO-7475 monotherapy and combinations with ONO-4538 in patients with advanced or metastatic solid tumors","other_id":"ONO-7475-02 / ONO-4538-74","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with histologically or cytologically confirmed advanced or metastatic solid\r\n             tumors\r\n\r\n          -  ECOG Performance Status 01\r\n\r\n          -  Patients with life expectancy of at least 3 months\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with history of severe allergy\r\n\r\n          -  Patients with multiple cancers\r\n      ","sponsor":"Ono Pharmaceutical Co. Ltd","sponsor_type":"Industry","conditions":"Advanced or Metastatic Solid Tumors","interventions":[{"intervention_type":"Drug","name":"Drug: ONO-7475","description":"ONO-7475 specified dose on specified days"},{"intervention_type":"Drug","name":"Drug: ONO-7475 + ONO-4538","description":"ONO-7475+ONO-4538 specified dose on specified days"}],"outcomes":[{"outcome_type":"primary","measure":"Number of paticipants with dose-limiting toxicities during the DLT evaluation period","time_frame":"28 days"},{"outcome_type":"primary","measure":"Incidence and severity of adverse events as assessed by CTCAE v4.0 to determine the tolerability and safety","time_frame":"Through study completion, an average of 1 year"},{"outcome_type":"secondary","measure":"Pharmacokinetics (Cmax)","time_frame":"Through study completion","description":"Assessment of the maximum plasma concentration of ONO-7475 both alone and in combination with ONO-4538"},{"outcome_type":"secondary","measure":"Pharmacokinetics (Tmax)","time_frame":"Through study completion","description":"Assessment of the time to reach maximum observed plasma concentration of ONO-7475 both alone and in combination with ONO-4538"},{"outcome_type":"secondary","measure":"Pharmacokinetics (AUC)","time_frame":"Through study completion","description":"Assessment of the plasma area under the curve of ONO-7475 both alone and in combination with ONO-4538"}]}
{"nct_id":"NCT03662698","start_date":"2018-10-12","phase":"N/A","enrollment":57,"brief_title":"Effect of Guided Imagery for Radiotherapy-Related Distress in Patients With Head and Neck Cancer","official_title":"Effect of Guided Imagery for Radiotherapy-Related Distress: A Randomized, Controlled Trial for Patients With Head and Neck Cancer","primary_completion_date":"2020-11-09","study_type":"Interventional","rec_status":"Completed","completion_date":"2021-01-08","last_update":"2021-05-06","description":"The goal of this interdisciplinary pilot study is to evaluate the feasibility, acceptability and preliminary efficacy of a guided imagery intervention to reduce RT-related symptoms of anxiety and depression in patients with HNC relative to treatment as usual.","other_id":"18-1100.cc","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"Single","intervention_model_description":"Participants will be randomized to the guided imagery intervention or to treatment as usual.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":100,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Provision to sign and date the consent form.\r\n\r\n          2. Stated willingness to comply with all study procedures and be available for the\r\n             duration of the study.\r\n\r\n          3. Be aged 18 - 100.\r\n\r\n          4. Ability to read and communicate in English.\r\n\r\n          5. A confirmed malignancy of the head and neck region (including metastases from other\r\n             primary tumors and cancers of unknown primary.\r\n\r\n          6. Initiation of RT at the University of Colorado Cancer Center.\r\n\r\n          7. Psychiatric and cognitive stability as assessed by chart review (i.e., no documented\r\n             dementia diagnosis or unmanaged psychiatric symptoms) and study personnel (i.e.,\r\n             ability to attend to meeting with study personnel).\r\n\r\n          8. Ability to meet remotely via internet connection or over the phone.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Any individual who does not meet the inclusion criteria.\r\n\r\n          2. Those who are determined, by mental health professionals, to be psychiatrically\r\n             unstable.\r\n      ","sponsor":"University of Colorado, Denver","sponsor_type":"Other","conditions":"Head and Neck Cancer","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Guided Imagery","description":"GI is a relaxation technique involving the visualization of images and is considered an adjuvant cancer therapy.The GI intervention will include two hour-long meetings between the participant and a trained interventionist. The sessions will include direct, written, and audio delivery of one of three GI vignettes. The patient will be able to choose one of the three vignettes. The approximately twelve minute long vignettes included in the study will be: Taking a Walk, Healthy Cell Alliance for Treatment, and Daily Intention (32). Patients will also be given access to psychosocial support resources (i.e., clinical psychologists and social workers) at UCCC."},{"intervention_type":"Other","name":"Other: Treatment as Usual","description":"This will include a tour of the treatment room and education about RT. Patients will also receive educational materials about RT including the process of RT and CT simulation, treatment side effects, pain management, and swallowing exercises. Participants in this condition will also have access to psychosocial support resources (i.e., clinical psychologists and social workers) at UCCC."}],"outcomes":[{"outcome_type":"primary","measure":"The desire for patients to want to use Guided Imagery while undergoing radiotherapy: [Feasibility]","time_frame":"From baseline to one month post-radiotherapy, up to 12 weeks, over 2 years.","description":"Feasibility of intervention use will be assessed through rates of study enrollment."},{"outcome_type":"primary","measure":"The desire for patients to want to use Guided Imagery while undergoing radiotherapy: [Feasibility]","time_frame":"From baseline to one month post-radiotherapy, up to 12 weeks, over 2 years.","description":"Feasibility of intervention use will be assessed through rates of GI session attendance."},{"outcome_type":"primary","measure":"The desire for patients to want to use Guided Imagery while undergoing radiotherapy: [Feasibility]","time_frame":"From baseline to one month post-radiotherapy, up to 12 weeks, over 2 years.","description":"Feasibility of intervention use will be assessed through self-reported use of the GI intervention measured through timeline follow-back."},{"outcome_type":"primary","measure":"The amount of patients who find using Guided Imagery beneficial as a form of treatment while undergoing radiotherapy: [Acceptability]","time_frame":"From baseline to one month post-radiotherapy, up to 12 weeks, over 2 years.","description":"Acceptability of the intervention will be assessed through qualitative interviews with intervention participants. The interviews will assess participant experience in the intervention including thoughts about the intervention content and structure of the intervention. Qualitative data regarding acceptability of the intervention will be gathered through one-on-one, standardized open-ended interviews."},{"outcome_type":"secondary","measure":"The effect Guided Imagery has on distress while undergoing radiotherapy: [Impact]","time_frame":"From baseline to one month post-radiotherapy, up to 12 weeks, over 2 years.","description":"Assess the impact of the GI intervention on symptoms of anxiety and depression in patients with head and neck cancer using the Hospital Anxiety and Depression Scales (HADS)."},{"outcome_type":"secondary","measure":"The effect Guided Imagery has on distress while undergoing radiotherapy: [Impact]","time_frame":"From baseline to one month post-radiotherapy, up to 12 weeks, over 2 years.","description":"Assess the impact of the GI intervention on symptoms of anxiety and depression in patients with head and neck cancer using the Memorial Symptom Assessment Scale Short Form (MSAS-SF)."},{"outcome_type":"secondary","measure":"The effect Guided Imagery has on distress while undergoing radiotherapy: [Impact]","time_frame":"From baseline to one month post-radiotherapy, up to 12 weeks, over 2 years.","description":"Assess the impact of the GI intervention on symptoms of anxiety and depression in patients with head and neck cancer using the Functional Assessment of Cancer Therapy-Head and Neck Version (FACT-HN)."}]}
{"nct_id":"NCT03667898","start_date":"2018-10-08","phase":"N/A","enrollment":27,"brief_title":"Intelligent Needle Tip Tracking Using Ultrasound Imaging for Lumbar Plexus Blocks","official_title":"Intelligent Needle Tip Tracking Using Ultrasound Imaging for Lumbar Plexus Blocks","primary_completion_date":"2018-10-26","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-11-30","last_update":"2018-12-12","description":"In a randomized controlled crossover study design, ultrasound guided lumbar plexus blocks will be performed with and without the aid of a needle tip tracking (NTT) system. Specialists in anaesthesiology with average experience in ultrasound guided peripheral nerve block (PNB) techniques will perform the blocks. 27 volunteers will be included. The primary objective is to investigate the effect of the NTT system on performance time, as a measure for improved block performance. Secondary objectives are the effects of the NTT system on dexterity, peripheral nerve block characteristics, subjective experience, and peripheral block performance.","other_id":"2018/1100","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Other","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  American Society of Anesthesiologists (ASA) physical status 1 or 2\r\n\r\n          -  Volunteers that have given informed written consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  BMI < 18 kg/m2\r\n\r\n          -  BMI > 35 kg/m2\r\n\r\n          -  Body weight > 95 kg\r\n\r\n          -  Volunteers that cannot cooperate during the examination\r\n\r\n          -  Volunteers that do not speak or understand Norwegian language\r\n\r\n          -  Volunteers with neurologic disease, nerve- or vascular impairment\r\n\r\n          -  Volunteers with known coagulopathy\r\n\r\n          -  Volunteers that are allergic to Lidocaine or other local anaesthetic agents\r\n\r\n          -  Medications at the investigators discretion\r\n\r\n          -  Volunteers with concomitant medical treatments interfering with PNB treatment\r\n\r\n          -  Skin disease or infection affecting the whole-body surface or within the area of\r\n             examination\r\n\r\n          -  Any reason why, in the opinion of the investigators, the volunteer should not\r\n             participate\r\n\r\n          -  Subject participates in a potentially confounding drug or device trial during the\r\n             course of the study\r\n\r\n          -  Pregnancy and lactation period\r\n\r\n          -  Women of childbearing potential who do not use an effective and secure method for\r\n             birth control\r\n      ","sponsor":"Oslo University Hospital","sponsor_type":"Other","conditions":"Nerve Block","interventions":[{"intervention_type":"Procedure","name":"Procedure: Lumbar plexus block using NTT","description":"An lumbar plexus block is performed using ultrasound guidance with needle tip tracking."},{"intervention_type":"Procedure","name":"Procedure: Lumbar plexus block without NTT","description":"An lumbar plexus block is performed using ultrasound guidance without needle tip tracking."}],"outcomes":[{"outcome_type":"secondary","measure":"Number of intended movements (probe hand)","time_frame":"During peripheral nerve block procedure","description":"Measured by motion analysis from insertion of the block needle (skin puncture) until finishing LA injection"},{"outcome_type":"secondary","measure":"Distance travelled by needling hand","time_frame":"During peripheral nerve block procedure","description":"Measured by motion analysis from insertion of the block needle (skin puncture) until finishing LA injection"},{"outcome_type":"secondary","measure":"Distance travelled by probe hand","time_frame":"During peripheral nerve block procedure","description":"Measured by motion analysis from insertion of the block needle (skin puncture) until finishing LA injection"},{"outcome_type":"secondary","measure":"Number of intended movements (needling hand)","time_frame":"During peripheral nerve block procedure","description":"Measured by motion analysis from insertion of the block needle (skin puncture) until finishing LA injection"},{"outcome_type":"primary","measure":"Performance time","time_frame":"During peripheral nerve block procedure","description":"Performance time is defined as the time from insertion of the block needle (skin puncture) until finishing local anaesthetic (LA) injection"},{"outcome_type":"secondary","measure":"Block success","time_frame":"30 minutes after peripheral nerve block procedure","description":"A sensory block is defined as successful when there is analgesia (no sensation for touch) or anaesthesia (no sensation at all) involving all five nerves distal to the elbow"},{"outcome_type":"secondary","measure":"Block onset time","time_frame":"Within 30 minutes after peripheral nerve block procedure","description":"Block onset time is defined as the time between the end of LA injection and development of a successful sensory block"},{"outcome_type":"secondary","measure":"Block duration","time_frame":"Within 240 minutes after peripheral nerve block procedure","description":"Block duration is the time from the end of LA injection until at least one of the nerves involved in the sensory block has recovered"},{"outcome_type":"secondary","measure":"Quantified discomfort during block performance","time_frame":"Immediately after peripheral nerve block procedure","description":"The participants are asked about discomfort during the block procedure using a numeric rating scale (scale range 0 - 10; 0 = no discomfort; 10 = worst discomfort imaginable)"},{"outcome_type":"secondary","measure":"Confidence in block success","time_frame":"Immediately after peripheral nerve block procedure","description":"The anaesthetist is asked if he expects the block to be successful using a numeric rating scale (scale range 0 - 10; 0 = block success unlikely; 10 = block success very likely)"}]}
{"nct_id":"NCT03693430","start_date":"2018-10-05","phase":"Phase 3","enrollment":304,"brief_title":"Two-year Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity","official_title":"Two-year Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity","primary_completion_date":"2021-01-29","study_type":"Interventional","rec_status":"Completed","completion_date":"2021-03-23","last_update":"2021-04-19","description":"This study will look at the change in body weight from the start to the end of the study. Researchers will compare the weight loss in people taking semaglutide (a new medicine) to people taking \"dummy\" medicine. In addition to taking the medicine, participants will also have talks with study staff about healthy food choices, how the participant can be more physically active and what participants can do to lose weight. Participants will either get semaglutide or \"dummy\" medicine - which treatment the participant gets is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 2 years. The participants will have 19 clinic visits and 15 phone calls with the study doctor.","other_id":"NN9536-4378","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female, age more than or equal to 18 years at the time of signing informed\r\n             consent\r\n\r\n          -  Body mass index (BMI) more than or equal to 30 kg/m^2 or more than or equal to 27\r\n             kg/m^2 with the presence of at least one of the following weight-related comorbidities\r\n             (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or\r\n             cardiovascular disease\r\n\r\n          -  History of at least one self-reported unsuccessful dietary effort to lose body weight\r\n\r\n        Exclusion criteria:\r\n\r\n          -  HbA1c more than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory\r\n             at screening\r\n\r\n          -  A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before\r\n             screening irrespective of medical records\r\n      ","sponsor":"Novo Nordisk A/S","sponsor_type":"Industry","conditions":"Overweight|Obesity","interventions":[{"intervention_type":"Drug","name":"Drug: Semaglutide","description":"Subcutaneous (s.c., under the skin) injections of semaglutide once weekly at escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 weeks"},{"intervention_type":"Drug","name":"Drug: Placebo (Semaglutide)","description":"S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 weeks"}],"outcomes":[{"outcome_type":"secondary","measure":"Number of serious adverse events (SAEs)","time_frame":"Week 0, week 111","description":"Number of events"},{"outcome_type":"secondary","measure":"Change in pulse","time_frame":"Week 0, week 104","description":"Measured in beats per minute"},{"outcome_type":"secondary","measure":"Change in amylase","time_frame":"Week 0, week 104","description":"Measured in U/L"},{"outcome_type":"secondary","measure":"Change in lipase","time_frame":"Week 0, week 104","description":"Measured in U/L"},{"outcome_type":"secondary","measure":"Change in calcitonin","time_frame":"Week 0, week 104","description":"Measured in ng/L"},{"outcome_type":"secondary","measure":"Subjects who achieve (yes/no): body weight reduction more than or equal to 5%","time_frame":"Week 0, week 52","description":"Number of subjects"},{"outcome_type":"secondary","measure":"Subjects who achieve (yes/no): body weight reduction more than or equal to 10%","time_frame":"Week 0, week 52","description":"Number of subjects"},{"outcome_type":"secondary","measure":"Subjects who achieve (yes/no): body weight reduction more than or equal to 15%","time_frame":"Week 0, week 52","description":"Number of subjects"},{"outcome_type":"secondary","measure":"Number of treatment-emergent adverse events (TEAEs)","time_frame":"Week 0, week 111","description":"Number of events"},{"outcome_type":"primary","measure":"Change in body weight","time_frame":"Week 0, week 104","description":"Measured in %"},{"outcome_type":"primary","measure":"Subjects who achieve (yes/no): body weight reduction more than or equal to 5%","time_frame":"Week 0, week 104","description":"Number of subjects"},{"outcome_type":"secondary","measure":"Subjects who achieve (yes/no): body weight reduction more than or equal to 10%","time_frame":"Week 0, week 104","description":"Number of subjects"},{"outcome_type":"secondary","measure":"Subjects who achieve (yes/no): body weight reduction more than or equal to 15%","time_frame":"Week 0, week 104","description":"Number of subjects"},{"outcome_type":"secondary","measure":"Change in waist circumference","time_frame":"Week 0, week 104","description":"Measured in cm"},{"outcome_type":"secondary","measure":"Change in systolic blood pressure","time_frame":"Week 0, week 104","description":"Measured in mmHg"},{"outcome_type":"secondary","measure":"Change in body weight","time_frame":"Week 0, week 104","description":"Measured in kg"},{"outcome_type":"secondary","measure":"Change in body mass index (BMI)","time_frame":"Week 0, week 104","description":"Measured in kg/m^2"},{"outcome_type":"secondary","measure":"Change in hemoglobin A1c (HbA1c)","time_frame":"Week 0, week 104","description":"Measured in %"},{"outcome_type":"secondary","measure":"Change in HbA1c","time_frame":"Week 0, week 104","description":"Measured in mmol/mol"},{"outcome_type":"secondary","measure":"Change in fasting plasma glucose","time_frame":"Week 0, week 104","description":"Measured in mg/dL"},{"outcome_type":"secondary","measure":"Change in fasting serum insulin","time_frame":"Week 0, week 104","description":"Measured in micro IU/mL"},{"outcome_type":"secondary","measure":"Change in diastolic blood pressure","time_frame":"Week 0, week 104","description":"Measured in mmHg"},{"outcome_type":"secondary","measure":"Change in total cholesterol","time_frame":"Week 0, week 104","description":"Measured in mg/dL"},{"outcome_type":"secondary","measure":"Change in high density lipoprotein (HDL) cholesterol","time_frame":"Week 0, week 104","description":"Measured in mg/dL"},{"outcome_type":"secondary","measure":"Change in low density lipoprotein (LDL) cholesterol","time_frame":"Week 0, week 104","description":"Measured in mg/dL"},{"outcome_type":"secondary","measure":"Change in very low density lipoprotein (VLDL) cholesterol","time_frame":"Week 0, week 104","description":"Measured in mg/dL"},{"outcome_type":"secondary","measure":"Change in free fatty acids","time_frame":"Week 0, week 104","description":"Measured in mg/dL"},{"outcome_type":"secondary","measure":"Change in triglycerides","time_frame":"Week 0, week 104","description":"Measured in mg/dL"},{"outcome_type":"secondary","measure":"Change in high sensitivity C-Reactive Protein","time_frame":"Week 0, week 104","description":"Measured in mg/L"},{"outcome_type":"secondary","measure":"Change in body weight","time_frame":"Week 0, week 52","description":"Measured in %"},{"outcome_type":"secondary","measure":"Change in body weight","time_frame":"Week 0, week 52","description":"Measured in kg"},{"outcome_type":"secondary","measure":"Change in BMI","time_frame":"Week 0, week 52","description":"Measured in kg/m^2"},{"outcome_type":"secondary","measure":"Change in waist circumference","time_frame":"Week 0, week 52","description":"Measured in cm"}]}
{"nct_id":"NCT03648866","start_date":"2018-10-01","enrollment":30,"brief_title":"A Thematic Analysis of Compassion Rounds","official_title":"A Thematic Analysis of the Effects of Compassion Rounds on Clinicians and the Families of NICU Patients","primary_completion_date":"2019-07-31","study_type":"Observational","rec_status":"Completed","completion_date":"2019-08-28","last_update":"2021-05-06","description":"The primary objective of this thematic analysis is to understand the experience of \"Compassion Rounds\" for patients, families, friends, and clinicians. The secondary objective of this study is to evaluate and interpret data to determine best practice recommendations for standardization and scalability.","other_id":"1320386","observational_model":"Other","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Participants will be recruited from participants in compassion rounding, including\r\n        patients, their loved ones, physicians, chaplains, social workers, nurses, and other care\r\n        providers.","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. An employee of Florida Hospital or Adventist Health System, or a physician with\r\n             privileges there, or a patient, or a family or friend who has participated in\r\n             compassion rounding at a Florida Hospital critical care unit\r\n\r\n          2. Over the age of 18\r\n\r\n          3. Able to provide informed consent\r\n\r\n          4. Must speak and understand English\r\n\r\n          5. Willing and able to provide a contact phone number\r\n\r\n        Exclusion Criteria:\r\n\r\n        1. Discernible cognitive impairment\r\n      ","sponsor":"AdventHealth","sponsor_type":"Other","conditions":"Spiritual Wellness","interventions":[{"intervention_type":"Other","name":"Other: interview","description":"Initial interview and potential follow-up interviews and focus group with Florida Hospital employees.\r\nInterview participants in compassion rounds"}],"outcomes":[{"outcome_type":"primary","measure":"Validated Thematic Framework to Explain the Effects of Compassion Rounding","time_frame":"five months","description":"Analysis of data collected throughout the study will result in a validated theoretical framework to understand and explain the psychosocial processes that influence participant experience and reported outcomes."},{"outcome_type":"secondary","measure":"Compendium of Evidence-Based Best Practices for the Implementation of Compassion Rounding","time_frame":"five months","description":"Analysis of data collected throughout the study will result in an evidence-based compendium of best practices for the implementation of compassion rounding."}]}
{"nct_id":"NCT03709199","start_date":"2018-10-01","enrollment":240,"brief_title":"Long Term Follow up of Children Enrolled in the REDvent Study","official_title":"The Effect of Intensive Care Unit Therapies and Mechanical Ventilation Strategy on Long Term Outcome in Pediatric ARDS A Follow-up of the Real-time Effort Driven VENTilator Management Study (REDvent)","primary_completion_date":"2023-12-01","study_type":"Observational","rec_status":"Recruiting","completion_date":"2024-03-01","last_update":"2021-09-16","description":"This is a prospective observational follow-up study of children enrolled in a single center randomized controlled trial (REDvent). Nearly 50% of adult Acute Respiratory Distress Syndrome (ARDS) survivors are left with significant abnormalities in pulmonary, physical, neurocognitive function and Health Related Quality of Life (HRQL) which may persist for years.Data in pediatric ARDS (PARDS) survivors is limited. More importantly, there are no data identifying potentially modifiable factors during ICU care which are associated with long term impairments, which may include medication choices, or complications from mechanical ventilator (MV) management in the ICU including ventilator induced lung injury (VILI) or ventilator induced diaphragm dysfunction (VIDD). The Real-time effort driven ventilator (REDvent) trial is testing a ventialtor management algorithm which may prevent VIDD and VILI. VIDD and VILI have strong biologic plausibility to affect the post-ICU health of children with likely sustained effects on lung repair and muscle strength. Moreover, common medication choices (i.e. neuromuscular blockade, corticosteroids) or other complications in the ICU (i.e. delirium) are likely to have independent effects on the long term health of these children. This proposed study will obtain serial follow-up of subjects enrolled in REDvent (intervention and control patients). The central hypothesis is that preventing VIDD, VILI and shortening time on MV will have a measureable impact on longer term function by mitigating abnormalities in pulmonary function (PFTs), neurocognitive function and emotional health, functional status and HRQL after hospital discharge for children with PARDS. For all domains, the investigators will determine the frequency, severity and trajectory of recovery of abnormalities amongst PARDS survivors after ICU discharge, identify risk factors for their development, and determine if they are prevented by REDvent. They will leverage the detailed and study specific respiratory physiology data being obtained in REDvent, and use a variety of multi-variable models for comprehensive analysis. Completion of this study will enable the investigators to identify ICU related therapies associated with poor long term outcome, and determine whether they can be mitigated by REDvent.","other_id":"CHLA-18-00354","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":0.08333,"maximum_age":18,"population":"This is a long term follow-up of children already enrolled in the RED-vent study.","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Children > 1 month (at least 44 weeks Corrected Gestational Age) and  18 years of age\r\n             AND\r\n\r\n          2. Supported on mechanical ventilation for pulmonary parenchymal disease (i.e.,\r\n             pneumonia, bronchiolitis, Pediatric Acute Respiratory Distress Syndrome (PARDS)) with\r\n             Oxygen Saturation Index (OSI)  5 or Oxygenation Index (OI) 4 115 AND\r\n\r\n          3. Who are within 48 hours of initiation of invasive mechanical ventilation (allow for up\r\n             to 72 hours for those transferred from another institution) AND\r\n\r\n          4. Enrolled in the REDvent Study\r\n\r\n        Exclusion Criteria (1-5 are REDvent exclusion):\r\n\r\n          1. Contraindications to use of an esophageal catheter (i.e. severe mucosal bleeding,\r\n             nasal encephalocele, transphenoidal surgery) OR\r\n\r\n          2. Contraindications to use of RIP bands (i.e. omphalocele, chest immobilizer or cast) OR\r\n\r\n          3. Conditions precluding diaphragm ultrasound measurement (i.e. abdominal wall defects,\r\n             pregnancy) OR\r\n\r\n          4. Conditions precluding conventional methods of weaning (i.e., status asthmaticus,\r\n             severe lower airway obstruction, critical airway, intracranial hypertension, Extra\r\n             Corporeal Life Support (ECLS), intubation for UAO, tracheostomy, DNR, severe chronic\r\n             respiratory failure, spinal cord injury above lumbar region, cyanotic heart disease\r\n             (unrepaired or palliated)) OR\r\n\r\n          5. Primary Attending physician refuses (will be cleared with primary attending before\r\n             approaching the patient) OR\r\n\r\n          6. Death in the ICU OR\r\n\r\n          7. New DNR orders during acute illness in ICU OR\r\n\r\n          8. Primary Language not English or Spanish OR\r\n\r\n          9. Children in foster care or a ward of the state.\r\n      ","sponsor":"Children's Hospital Los Angeles","sponsor_type":"Other","conditions":"Respiratory Distress Syndrome, Adult|Ventilator-Induced Lung Injury|Neurocognitive Dysfunction|Quality of Life|Respiration Disorders","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Ventilation Inhomogeneity","description":"Ventilation inhomogeneity will be measured using the Lung Clearance Index (LCI), derived from multiple breath Nitrogen washout during tidal breathing, measured by a mouthpiece or mask covering nose and mouth."},{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Diaphragm Ultrasound","description":"Diaphragm thickness and contractile activity measured during tidal breathing."},{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Respiratory Inductance Plethysmography","description":"Measure of thoraco-abdominal asynchrony during tidal breathing"},{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Spirometry","description":"Measurement of Forced Expiratory Volume (FEV1), Forced Vital Capacity and other lung volumes using standard pulmonary function techniques"},{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Functional Residual Capacity","description":"Measurement using body box plethysmography of functional residual capacity and other lung volumes using standard pulmonary function techniques"},{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: MIP/MEP","description":"Measurement of maximal inspiratory and expiratory pressures during airway occlusion"},{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: 6 minute walk test","description":"Measurement of cardio-respiratory function and capabilities during treadmill walking for 6 minutes."},{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Neurocognitive Testing","description":"Detailed in person neuro-cognitive testing using standardized inventories using either the Battelle Developmental Inventory, second edition (Battelle-2) (age birth to 5 years 11 months) and the Wechsler Intelligence Scale for Children, fifth edition (WISC-5, for age 6 years to 19 years)."},{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Emotional Health Assessment","description":"In person and written assessments of children and parents using the Behavioral Assessment System for Children, third edition (BASC-3) for children  2 years and the UCLA PTSD Reaction Index (UCLA RI) for children  8 years."},{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Health Related Quality of Life","description":"Standardized instruments to assess (in person, over the phone, or via mail) health related quality of life in children. Parent and child questionnaires."},{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Functional Status","description":"Survey of overall functional status, administrated by asking a series of questions to patient and families."},{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Respiratory Status Questionnaire","description":"Survey of respiratory health, administrated by asking a series of questions to patient and families."}],"outcomes":[{"outcome_type":"secondary","measure":"Respiratory Muscle Strength Maximum expiratory pressure (MEP)","time_frame":"6 months after ICU discharge","description":"Maximal expiratory pressure measurements during airway occlusion in cm H20"},{"outcome_type":"secondary","measure":"Respiratory Muscle Strength Maximum inspiratory pressure (MIP)","time_frame":"Prior to Hospital Discharge and no more than 1 month after ICU discharge","description":"Maximal inspiratory pressure measurements during airway occlusion in cm H20"},{"outcome_type":"secondary","measure":"Respiratory Muscle Strength Maximum inspiratory pressure (MIP)","time_frame":"6 months after ICU discharge","description":"Maximal inspiratory pressure measurements during airway occlusion in cm H20"},{"outcome_type":"primary","measure":"Ventilation In-homogeneity using lung clearance index with nitrogen washout","time_frame":"6 months after ICU discharge","description":"Measured by lung clearance index during multiple breath nitrogen washout testing reported as percent predicted based on age and height as well as a raw number typically ranging from 5-15."},{"outcome_type":"primary","measure":"Neurocognitive function using a standardized score derived from Batelle-2 or WISC-5 cognitive tests","time_frame":"3 months after ICU discharge","description":"Standardized IQ-like score derived from Batelle-2 or WISC-5 cognitive tests based on age. Children < 6 years will receive the Batelle-2 and children >=6 will receive the WISC-5. Overall score will be use for analysis with a higher value indicating better cognitive function. The range of \"average\" cognitive function lies between 90-109. Both tests are scored on the same scale"},{"outcome_type":"primary","measure":"Health Related Quality of Life as measured by PedsQL generic core scale","time_frame":"3 months after ICU discharge","description":"PedsQL generic core scale, with range from 0-100, with the higher score indicating better health related quality of life"},{"outcome_type":"secondary","measure":"Respiratory Muscle Strength Maximum expiratory pressure (MEP)","time_frame":"Prior to Hospital Discharge and no more than 1 month after ICU discharge","description":"Maximal expiratory pressure measurements during airway occlusion in cm H20"},{"outcome_type":"primary","measure":"Functional Status as measured by the pediatric functional status scale","time_frame":"3 months after ICU discharge","description":"Functional status scale which is scored from normal (score =1) to very severe dysfunction (score =5) in each of 6 domains. The sum score of all domains will be used for analysis, yielding a minimum possible score of 6 and a maximum possible score of 30. Analysis will focus on a change in FSS from baseline (assessed as functional status 1 month prior to ICU admission). An increase in the FSS from baseline to 3 months will be considered as a decline in functional status."},{"outcome_type":"secondary","measure":"Functional Residual Capacity (Lung volume at end-expiration).","time_frame":"Prior to Hospital Discharge and no more than 1 month after ICU discharge","description":"Measured by body box plethysmography and nitrogen washout techniques, normalized by age, height and gender. Values below or above normative values will be considered abnormal."},{"outcome_type":"secondary","measure":"Functional Residual Capacity (Lung volume at end-expiration).","time_frame":"6 months after ICU discharge","description":"Measured by body box plethysmography and nitrogen washout techniques, normalized by age, height and gender. Values below or above normative values will be considered abnormal."},{"outcome_type":"secondary","measure":"Phase Angle (a measure of thoraco-abdominal asynchrony and abnormal respiratory mechanics)","time_frame":"Prior to Hospital Discharge and no more than 1 month after ICU discharge","description":"Respiratory Inductance Plethysmography belts are used during tidal breathing to measure thoraco-abdominal asyncrhony. Higher values will be considered abnormal with a range from 0-180."},{"outcome_type":"secondary","measure":"Phase Angle (a measure of thoraco-abdominal asynchrony and abnormal respiratory mechanics)","time_frame":"6 Months after ICU Discharge","description":"Respiratory Inductance Plethysmography belts are used during tidal breathing to measure thoraco-abdominal asyncrhony. Higher values will be considered abnormal with a range from 0-180."},{"outcome_type":"secondary","measure":"Diaphragm Thickness on exhalation","time_frame":"Prior to Hospital Discharge and no more than 1 month after ICU discharge","description":"Diaphragm ultrasound measurement of thickness at end exhalation measured in zone of apposition of right hemi-diaphragm"},{"outcome_type":"secondary","measure":"Diaphragm Thickness on exhalation","time_frame":"6 months after ICU discharge","description":"Diaphragm ultrasound measurement of thickness at end exhalation measured in zone of apposition of right hemi-diaphragm"},{"outcome_type":"secondary","measure":"Diaphragm Thickness on inspiration","time_frame":"Prior to Hospital Discharge and no more than 1 month after ICU discharge","description":"Diaphragm ultrasound measurement of thickness at end inspiration measured in zone of apposition of right hemi-diaphragm"},{"outcome_type":"secondary","measure":"Diaphragm Thickness on inspiration","time_frame":"6 months after ICU discharge","description":"Diaphragm ultrasound measurement of thickness at end inspiration measured in zone of apposition of right hemi-diaphragm"},{"outcome_type":"secondary","measure":"Diaphragm Thickening fraction (measure of contractile activity)","time_frame":"Prior to Hospital Discharge and no more than 1 month after ICU discharge","description":"Diaphragm ultrasound measurement calculated as (thickness at end inspiration-thickness at end expiration)/(thickness at end expiration) measured in zone of apposition of right hemi-diaphragm."},{"outcome_type":"secondary","measure":"Diaphragm Thickening fraction (measure of contractile activity)","time_frame":"6 months after ICU discharge","description":"Diaphragm ultrasound measurement calculated as (thickness at end inspiration-thickness at end expiration)/(thickness at end expiration) measured in zone of apposition of right hemi-diaphragm."},{"outcome_type":"secondary","measure":"Ventilation In-homogeneity using lung clearance index with nitrogen washout","time_frame":"Prior to Hospital Discharge and no more than 1 month after ICU discharge","description":"Measured by lung clearance index during multiple breath nitrogen washout testing reported as percent predicted based on age and height as well as a raw number typically ranging from 5-15."},{"outcome_type":"secondary","measure":"Forced Expiratory Volume in 1 second (FEV1)","time_frame":"Prior to Hospital Discharge and no more than 1 month after ICU discharge","description":"Spirometry based measures of pulmonary function of forced expiratory volume, normalized based on age, height, and gender and reported as percent predicted."},{"outcome_type":"secondary","measure":"Forced Expiratory Volume in 1 second (FEV1)","time_frame":"6 months after ICU discharge","description":"Spirometry based measures of pulmonary function of forced expiratory volume, normalized based on age, height, and gender and reported as percent predicted."},{"outcome_type":"secondary","measure":"Forced Vital Capacity (FVC)","time_frame":"Prior to Hospital Discharge and no more than 1 month after ICU discharge","description":"Spirometry based measures of pulmonary function of forced vital capacity, normalized based on age, height, and gender and reported as percent predicted."},{"outcome_type":"secondary","measure":"Forced Vital Capacity (FVC)","time_frame":"6 months after ICU discharge","description":"Spirometry based measures of pulmonary function of forced vital capacity, normalized based on age, height, and gender and reported as percent predicted."},{"outcome_type":"secondary","measure":"Forced expiratory flow at 25-75% (FEF 25-75)","time_frame":"Prior to Hospital Discharge and no more than 1 month after ICU discharge","description":"Spirometry based measures of pulmonary function of forced expiratory flow at 25-75% of breath, normalized based on age, height, and gender and reported as percent predicted."},{"outcome_type":"secondary","measure":"Forced expiratory flow at 25-75% (FEF 25-75)","time_frame":"6 months post ICU discharge","description":"Spirometry based measures of pulmonary function of forced expiratory flow at 25-75% of breath, normalized based on age, height, and gender and reported as percent predicted."},{"outcome_type":"secondary","measure":"VT - tidal volume from spirometry during tidal breathing","time_frame":"Prior to Hospital Discharge and no more than 1 month after ICU discharge","description":"Lung volume measurements obtained during tidal breathing, normalized in ml/kg ideal body weight."},{"outcome_type":"secondary","measure":"VT - tidal volume from spirometry during tidal breathing","time_frame":"6 months after ICU discharge","description":"Lung volume measurements obtained during tidal breathing, normalized in ml/kg ideal body weight."},{"outcome_type":"secondary","measure":"Total Lung Capacity- TLC measured during spirometry","time_frame":"Prior to Hospital Discharge and no more than 1 month after ICU discharge","description":"Lung volume measurements obtained during pulmonary function tests with spirometry and body box plethysmography to calculate total lung capacity, normalized by age, height and gender."},{"outcome_type":"secondary","measure":"Total Lung Capacity- TLC measured during spirometry","time_frame":"6 months after ICU discharge","description":"Lung volume measurements obtained during pulmonary function tests with spirometry and body box plethysmography to calculate total lung capacity, normalized by age, height and gender."},{"outcome_type":"secondary","measure":"Forced vital capacity- measured during spirometry","time_frame":"Prior to Hospital Discharge and no more than 1 month after ICU discharge","description":"Lung volume measurements obtained during pulmonary function tests with spirometry to calculate forced vital capacity, normalized by age, height and gender."},{"outcome_type":"secondary","measure":"Forced vital capacity- measured during spirometry","time_frame":"6 months after ICU discharge","description":"Lung volume measurements obtained during pulmonary function tests with spirometry to calculate forced vital capacity, normalized by age, height and gender."},{"outcome_type":"secondary","measure":"Neurocognitive function using a standardized score derived from Batelle-2 or WISC-5 cognitive tests","time_frame":"12 months after ICU discharge","description":"Standardized IQ-like score derived from Batelle-2 or WISC-5 cognitive tests. Overall score will be use for analysis with a higher value indicating better cognitive function. The range of \"average\" cognitive function lies between 90-109."},{"outcome_type":"secondary","measure":"Health Related Quality of Life as measured by PedsQL generic core scale","time_frame":"ICU discharge","description":"PedsQL generic core scale, with range from 0-100, with the higher score indicating better health related quality of life"},{"outcome_type":"secondary","measure":"Health Related Quality of Life as measured by PedsQL generic core scale","time_frame":"1 month after ICU discharge","description":"PedsQL generic core scale, with range from 0-100, with the higher score indicating better health related quality of life"},{"outcome_type":"secondary","measure":"Health Related Quality of Life as measured by PedsQL generic core scale","time_frame":"2 months after ICU discharge","description":"PedsQL generic core scale, with range from 0-100, with the higher score indicating better health related quality of life"},{"outcome_type":"secondary","measure":"Health Related Quality of Life as measured by PedsQL generic core scale","time_frame":"6 months after ICU discharge","description":"PedsQL generic core scale, with range from 0-100, with the higher score indicating better health related quality of life"},{"outcome_type":"secondary","measure":"Health Related Quality of Life as measured by PedsQL generic core scale","time_frame":"12 months after ICU discharge","description":"PedsQL generic core scale, with range from 0-100, with the higher score indicating better health related quality of life"},{"outcome_type":"secondary","measure":"Functional Status as measured by the pediatric functional status scale","time_frame":"ICU discharge","description":"Functional status scale which is scored from normal (score =1) to very severe dysfunction (score =5) in each of 6 domains. The sum score of all domains will be used for analysis, yielding a minimum possible score of 6 and a maximum possible score of 30. Analysis will focus on a change in FSS from baseline (assessed as functional status 1 month prior to ICU admission). An increase in the FSS from baseline will be considered as a decline in functional status."},{"outcome_type":"secondary","measure":"Functional Status as measured by the pediatric functional status scale","time_frame":"1 month after ICU discharge","description":"Functional status scale which is scored from normal (score =1) to very severe dysfunction (score =5) in each of 6 domains. The sum score of all domains will be used for analysis, yielding a minimum possible score of 6 and a maximum possible score of 30. Analysis will focus on a change in FSS from baseline (assessed as functional status 1 month prior to ICU admission). An increase in the FSS from baseline will be considered as a decline in functional status."},{"outcome_type":"secondary","measure":"Functional Status as measured by the pediatric functional status scale","time_frame":"2 months after ICU discharge","description":"Functional status scale which is scored from normal (score =1) to very severe dysfunction (score =5) in each of 6 domains. The sum score of all domains will be used for analysis, yielding a minimum possible score of 6 and a maximum possible score of 30. Analysis will focus on a change in FSS from baseline (assessed as functional status 1 month prior to ICU admission). An increase in the FSS from baseline will be considered as a decline in functional status."},{"outcome_type":"secondary","measure":"Functional Status as measured by the pediatric functional status scale","time_frame":"6 months after ICU discharge","description":"Functional status scale which is scored from normal (score =1) to very severe dysfunction (score =5) in each of 6 domains. The sum score of all domains will be used for analysis, yielding a minimum possible score of 6 and a maximum possible score of 30. Analysis will focus on a change in FSS from baseline (assessed as functional status 1 month prior to ICU admission). An increase in the FSS from baseline will be considered as a decline in functional status."},{"outcome_type":"secondary","measure":"Functional Status as measured by the pediatric functional status scale","time_frame":"12 months after ICU discharge","description":"Functional status scale which is scored from normal (score =1) to very severe dysfunction (score =5) in each of 6 domains. The sum score of all domains will be used for analysis, yielding a minimum possible score of 6 and a maximum possible score of 30. Analysis will focus on a change in FSS from baseline (assessed as functional status 1 month prior to ICU admission). An increase in the FSS from baseline will be considered as a decline in functional status."},{"outcome_type":"secondary","measure":"Respiratory Status - questionnaire detailing respiratory medications and therapies as well as healthcare utilization.","time_frame":"ICU discharge","description":"Series of questions to detail respiratory based morbidity"},{"outcome_type":"secondary","measure":"Respiratory Status - questionnaire detailing respiratory medications and therapies as well as healthcare utilization.","time_frame":"1 month after ICU discharge","description":"Series of questions to detail respiratory based morbidity"},{"outcome_type":"secondary","measure":"Respiratory Status - questionnaire detailing respiratory medications and therapies as well as healthcare utilization.","time_frame":"2 months after ICU discharge","description":"Series of questions to detail respiratory based morbidity"},{"outcome_type":"secondary","measure":"Respiratory Status - questionnaire detailing respiratory medications and therapies as well as healthcare utilization.","time_frame":"3 months after ICU discharge","description":"Series of questions to detail respiratory based morbidity"},{"outcome_type":"secondary","measure":"Respiratory Status - questionnaire detailing respiratory medications and therapies as well as healthcare utilization.","time_frame":"6 months after ICU discharge","description":"Series of questions to detail respiratory based morbidity"},{"outcome_type":"secondary","measure":"Respiratory Status - questionnaire detailing respiratory medications and therapies as well as healthcare utilization.","time_frame":"12 months after ICU discharge","description":"Series of questions to detail respiratory based morbidity"},{"outcome_type":"secondary","measure":"Emotional Health Outcomes using the (BASC-3) to assess emotional and behavioral abnormalities and UCLA Reaction Index to assess post traumatic stress","time_frame":"3 months after ICU discharge","description":"The Behavioral Assessment System for Children, third edition (BASC-3) for children ≥ 2 years will be used to assess for emotional and behavioral abnormalities as a survey tool. The UCLA PTSD Reaction Index (UCLA RI) will be used for children ≥ 8 years. The UCLA RI is a semi-structured interview assessing for exposure to traumatic events and PTS in children."},{"outcome_type":"secondary","measure":"Emotional Health Outcomes using the (BASC-3) to assess emotional and behavioral abnormalities and UCLA Reaction Index to assess post traumatic stress","time_frame":"12 months after ICU discharge","description":"The Behavioral Assessment System for Children, third edition (BASC-3) for children ≥ 2 years will be used to assess for emotional and behavioral abnormalities as a survey tool. The UCLA PTSD Reaction Index (UCLA RI) will be used for children ≥ 8 years. The UCLA RI is a semi-structured interview assessing for exposure to traumatic events and PTS in children."},{"outcome_type":"other","measure":"6 minute walk test","time_frame":"Prior to Hospital Discharge and no more than 1 month after ICU discharge","description":"Measure of cardio-respiratory function after treadmill walking"},{"outcome_type":"other","measure":"6 minute walk test","time_frame":"6 months after ICU discharge","description":"Measure of cardio-respiratory function after treadmill walking"}]}
{"nct_id":"NCT03709186","start_date":"2018-10-01","enrollment":100,"brief_title":"Radiomic Markers for Breast Cancer Metastasis and Treatment Response Using MRI","official_title":"Radiomic Markers for Breast Cancer Metastasis Using Dynamic Contrast Enhanced MRI and Diffusion-Weighted MRI","primary_completion_date":"2020-09-01","study_type":"Observational [Patient Registry]","rec_status":"Active, not recruiting","completion_date":"2021-01-01","last_update":"2019-10-30","description":"The primary aim of the study is to identify radiomic features as biomarkers of metastatic progression following primary therapy.","other_id":"214-2018","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"This study will enrol women and men with a pathologically-confirmed diagnosis of invasive\r\n        breast cancer that is stage I-III according to the AJCC v7 criteria.","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Subjects must give appropriate written informed consent prior to participation in the\r\n             study;\r\n\r\n          2. Subjects must be able and willing to comply with the safety procedures during the\r\n             scanning period;\r\n\r\n          3. Subjects must be men and women age 18+\r\n\r\n          4. Biopsy-confirmed diagnosis of invasive breast cancer; (ER+/-, PR+/-, HER2+/-).\r\n\r\n          5. Stage I-III disease according to the AJCC v7 criteria.\r\n\r\n          6. Patients with sufficient renal function (creatinine clearance, i.e., >=30 mL/min/1.73\r\n             m2).\r\n\r\n          7. Primary treatments can include neoadjuvant chemotherapy or surgery\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  1. Subjects with a past medical history of abnormalities, significant injury, or\r\n             medical or surgical procedures (e.g. Silicone/saline implants) involving either\r\n             breast, exclusive of the lesion at issue.\r\n\r\n             2. Subjects with any dermatologic abnormalities (including tattoos, open sores, or\r\n             breached skin) involving either breast 3. Subjects with a current or past medical\r\n             history of connective tissue disease 4. Subjects who are pregnant or lactating 5.\r\n             Subjects with an implanted electronic device such as a cardiac pacemaker,\r\n             defibrillator, or neurological stimulator 6. Subjects, who, in the opinion of the\r\n             investigator or clinical research coordinator, may not otherwise be appropriate for\r\n             inclusion into the study, such as significant anxiety, history of musculoskeletal\r\n             disease which may predispose them to discomfort during the imaging/scanning period.\r\n\r\n             7. Allergies to any contrast agent administered to this study.\r\n      ","sponsor":"Sunnybrook Health Sciences Centre","sponsor_type":"Other","conditions":"Invasive Breast Cancer","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Pathologic complete response (pCR)","time_frame":"Up to 60 months","description":"Evaluating the degree of absence of residual cancer cells"},{"outcome_type":"secondary","measure":"Time to distant breast cancer recurrence (months)","time_frame":"Up to 60 months","description":"Evaluating the time until a recurrence event has occurred in the breast."},{"outcome_type":"secondary","measure":"Time to distant metastasis","time_frame":"Up to 60 months","description":"Evaluating onset of distant metastasis"},{"outcome_type":"secondary","measure":"Time to death","time_frame":"Up to 60 months","description":"Evaluating time to cancer-related death"}]}
{"nct_id":"NCT03496519","start_date":"2018-10-01","phase":"Phase 1","enrollment":0,"brief_title":"Assessing the Combination of Durvalumab (MEDI4736) and Trabectedin in Solid Tumors","official_title":"A Phase I Study Assessing the Combination of Durvalumab (MEDI4736) and Trabectedin in Solid Tumors","primary_completion_date":"2021-10-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2021-10-31","last_update":"2018-10-09","description":"A phase 1 study examining the combination of Durvalumab (MEDI4736) and Trabectedin in various solid tumor types. The study seeks to determine a safe dose of the combination of study drugs and then examine this dose in larger groups of patients of specific tumor types to evaluate its anti-tumor efficacy. Treatment will continue in patients who respond for up to 1 year.","other_id":"17-1852.cc","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":99,"population":"","criteria":"\n        Inclusion Criteria at Screening and C1D1:\r\n\r\n          1. Ability to understand and the willingness to sign a written informed consent document\r\n\r\n          2. Written informed consent and any locally-required authorization (e.g., HIPAA in the\r\n             USA) obtained from the patient prior to performing any protocol-related procedures,\r\n             including screening evaluations\r\n\r\n          3. AGE  18\r\n\r\n          4. Alkaline phosphatase (ALP) level  upper limit of normal (ULN)\r\n\r\n          5. Aspartate aminotransferase (AST) and alanine amino transferase (ALT)  ULN\r\n\r\n          6. Bilirubin  ULN, if total bilirubin is > ULN, measure direct/indirect bilirubin to\r\n             evaluate for Gilbert's Syndrome (if direct bilirubin is within normal range, subject\r\n             may be eligible)\r\n\r\n          7. Albumin  2.5 g/dL\r\n\r\n          8. CPK  2.5 xULN\r\n\r\n          9. Body weight > 30 kg\r\n\r\n         10. ECOG performance status 0-1\r\n\r\n         11. Evidence of post-menopausal status or negative urinary or serum pregnancy test for\r\n             female pre-menopausal patients. Women will be considered post-menopausal if they have\r\n             been amenorrheic for 12 months without an alternative medical cause. The following\r\n             age-specific requirements apply:\r\n\r\n               -  Women <50 years of age would be considered post-menopausal if they have been\r\n                  amenorrheic for 12 months or more following cessation of exogenous hormonal\r\n                  treatments and if they have luteinizing hormone and follicle-stimulating hormone\r\n                  levels in the post-menopausal range for the institution or underwent surgical\r\n                  sterilization (bilateral oophorectomy or hysterectomy).\r\n\r\n               -  Women 50 years of age would be considered post-menopausal if they have been\r\n                  amenorrheic for 12 months or more following cessation of all exogenous hormonal\r\n                  treatments, had radiation-induced menopause with last menses >1 year ago, had\r\n                  chemotherapy-induced menopause with last menses >1 year ago, or underwent\r\n                  surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or\r\n                  hysterectomy).\r\n\r\n         12. Evaluable disease for dose escalation, measurable disease per RECIST 1.1 for dose\r\n             expansions\r\n\r\n         13. Hemoglobin  9 g/dL\r\n\r\n         14. Neutrophil count  1.5 x 10^9/L\r\n\r\n         15. Platelets  100 x 10^9/L\r\n\r\n         16. Measured creatinine clearance (CL)  50 mL/min or Calculated creatinine CL 50 mL/min\r\n             by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine\r\n             collection for determination of creatinine clearance:\r\n\r\n             This calculation will be performed by a member of the clinical study team\r\n\r\n             Males:\r\n\r\n             Creatinine CL (mL/min) = Weight (kg) x (140 - Age) / 72 x serum creatinine (mg/dL)\r\n\r\n             Females:\r\n\r\n             Creatinine CL (mL/min) = [Weight (kg) x (140 - Age)/72 x serum creatinine (mg/dL)] x\r\n             0.85\r\n\r\n         17. Any advanced unresectable/stage IV solid tumor with exception of primary CNS\r\n             malignancy is permitted.\r\n\r\n         18. Enrolled patients may be candidates for standard of care therapy with trabectedin or\r\n             second line/subsequent line treatment for advanced disease with PD-1/PD-L1 inhibitor\r\n             monotherapy. Otherwise they should have no standard of care option available or be\r\n             felt appropriate for a phase I clinical trial in the opinion of the treating\r\n             investigator. Prior PD-1/PD-L1 exposure is not an exclusion criteria.\r\n\r\n         19. For the expansion cohort of NSCLC patients previously treated with and having\r\n             progressed on immunotherapy patients must have no standard of care option available or\r\n             have contraindications to such treatment (including those who decline such treatment).\r\n\r\n         20. Patient is willing and able to comply with the protocol for the duration of the study\r\n             including undergoing treatment and scheduled visits and exams including follow up.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Strong inhibitors or inducers of cytochrome P450 3A (washout from prior use of such\r\n             agents before C1D1 must exceed 21 days).\r\n\r\n          2. Concurrent enrollment in another clinical study, unless it is an observational\r\n             (non-interventional) clinical study or during the follow-up period of an\r\n             interventional study.\r\n\r\n          3. Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine\r\n             therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies\r\n             or other investigational product)  28 days. However, if a therapy has a short\r\n             half-life, then patients may participate if they received prior treatment  28 days\r\n             before starting study treatment with approval from the PI and AstraZeneca/Janssen.\r\n             Acceptable washout periods include:\r\n\r\n               1. 3-14 days for prior TKI depending on half-life\r\n\r\n               2. 14-28 days for prior PD-1 or PD-L1 inhibitor treatment depending on the frequency\r\n                  of administration (i.e., wait one full cycle of prior PD-1 axis inhibition before\r\n                  starting study drugs)\r\n\r\n          4. Therapeutic radiation within 6 weeks of cycle 1 day 1. Exceptions are palliative\r\n             radiation and/or stereotactic radiation to non-target lesions.\r\n\r\n          5. If received prior immunotherapy must not have experienced one of the following:\r\n\r\n               -  A toxicity that led to permanent discontinuation of prior immunotherapy\r\n\r\n               -  All AEs while receiving prior immunotherapy must have completely resolved or\r\n                  resolved to baseline prior to screening for this study.\r\n\r\n               -  Must not have experienced a Grade 3 immune related AE or an immune related\r\n                  neurologic or ocular AE of any grade while receiving prior immunotherapy. NOTE:\r\n                  Patients with endocrine AE of Grade 2 are permitted to enroll if they are stably\r\n                  maintained on appropriate replacement therapy and are asymptomatic.\r\n\r\n               -  Must not have required the use of additional immunosuppression other than\r\n                  corticosteroids for the management of an AE and must not have experienced\r\n                  recurrence of an AE if re-challenged.\r\n\r\n          6. Prior treatment with trabectedin or trabectedin analog\r\n\r\n          7. History of another malignancy except for:\r\n\r\n               -  Malignancy treated with curative intent and with no known active disease 5 years\r\n                  before the first dose of study drugs and of low potential risk for recurrence\r\n\r\n               -  Adequately treated non-melanoma skin cancer or lentigo maligna without evidence\r\n                  of disease\r\n\r\n               -  Adequately treated carcinoma in situ without evidence of disease e.g., cervical\r\n                  cancer in situ\r\n\r\n          8. Mean QT interval corrected for heart rate (QTc) > 450 ms for males or > 470 msec for\r\n             females calculated from 3 electrocardiograms (ECGs) using Fredericia's Formula (within\r\n             at least 15 minutes, at least 5 minutes apart)\r\n\r\n          9. Current or prior use of systemic immunosuppressive medication within 28 days before\r\n             the first dose of durvalumab + trabectedin, with the exception of systemic\r\n             corticosteroids at physiological doses, which are not to exceed 10 mg/day of\r\n             prednisone, or an equivalent corticosteroid. The following are exceptions to this\r\n             criterion:\r\n\r\n             - Steroids as premedication for hypersensitivity reactions (e.g., CT scan\r\n             premedication)\r\n\r\n         10. Any unresolved toxicity (non-immune mediated) NCI CTCAE Grade  2 from previous\r\n             anticancer therapy with the exception of alopecia\r\n\r\n             - However, patients with irreversible toxicity not reasonably expected to be\r\n             exacerbated by the treatment with durvalumab + trabectedin may be included only after\r\n             consultation with the Principal Investigator.\r\n\r\n         11. Major surgical procedure (as defined by the Investigator) within 28 days prior to the\r\n             first dose of study drugs. Note: Local surgery of isolated lesions for palliative\r\n             intent is acceptable.\r\n\r\n         12. History of allogenic organ transplantation (both solid organ and bone marrow)\r\n\r\n         13. Active or prior documented autoimmune or inflammatory disorders (including\r\n             inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with\r\n             the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome,\r\n             or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid\r\n             arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this\r\n             criterion:\r\n\r\n               -  Patients with vitiligo or alopecia\r\n\r\n               -  Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on\r\n                  hormone replacement\r\n\r\n               -  Any chronic skin condition that does not require systemic therapy\r\n\r\n               -  Patients without active disease in the last 5 years may be included, but only\r\n                  after consultation with the PI\r\n\r\n               -  Patients with celiac disease controlled by diet alone\r\n\r\n         14. Uncontrolled intercurrent illness, including but not limited to, ongoing or active\r\n             infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable\r\n             angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic\r\n             gastrointestinal conditions associated with diarrhea, or psychiatric illness/social\r\n             situations that would limit compliance with study requirements, substantially increase\r\n             risk of incurring AEs or compromise the ability of the patient to give written\r\n             informed consent.\r\n\r\n         15. Cirrhosis of any Child Pugh class\r\n\r\n         16. Left ventricular ejection fraction less than 50%\r\n\r\n         17. History of pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis,\r\n             idiopathic pneumonitis or evidence of symptomatic interstitial lung disease on chest\r\n             computed tomography (CT).\r\n\r\n         18. History of leptomeningeal carcinomatosis\r\n\r\n         19. Has untreated central nervous system (CNS) metastases and/or carcinomatous meningitis\r\n             that meets RECIST criteria identified either on the baseline brain imaging obtained\r\n             during the screening period or identified prior to signing the informed consent form\r\n             (ICF). Patients whose brain metastases have been treated may participate provided they\r\n             show radiographic stability (defined as 2 brain images, both of which are obtained\r\n             after treatment to the brain metastases. These imaging scans should both be obtained\r\n             at least four weeks apart and show no evidence of intracranial progression). In\r\n             addition, any neurologic symptoms that developed either as a result of the brain\r\n             metastases or their treatment must have resolved or be stable either, without the use\r\n             of steroids, or are stable on a steroid dose of 10mg/day of prednisone or its\r\n             equivalent and not requiring anticonvulsants for at least 14 days prior to the start\r\n             of treatment.\r\n\r\n         20. History of active primary immunodeficiency\r\n\r\n         21. Active infection including tuberculosis (clinical evaluation that includes clinical\r\n             history, physical examination and radiographic findings, and TB testing in line with\r\n             local practice), hepatitis B (HBsAg positive), hepatitis C, or human immunodeficiency\r\n             virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection\r\n             (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HbsAg)\r\n             are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if\r\n             polymerase chain reaction is negative for HCV RNA.\r\n\r\n         22. Receipt of live attenuated vaccine within 30 days prior to the first dose of study\r\n             drugs. Note: Patients, if enrolled, should not receive live vaccine whilst receiving\r\n             treatment with study drugs and up to 90 days after the last dose of study drugs.\r\n\r\n         23. Female patients who are pregnant or breastfeeding or male or female patients of\r\n             reproductive potential who are not willing to employ effective birth control (as\r\n             defined in section 7.1 of protocol) from screening to 180 days after receipt of the\r\n             last dose of study drugs.\r\n\r\n         24. Known allergy or hypersensitivity to any of the study drugs or any of the study drug\r\n             excipients.\r\n\r\n         25. Prior randomisation or treatment in a previous durvalumab and/or tremelimumab clinical\r\n             study regardless of treatment arm assignment.\r\n\r\n         26. Judgment by the investigator that the patient is unsuitable to participate in the\r\n             study and the patient is unlikely to comply with study procedures, restrictions and\r\n             requirements.\r\n      ","sponsor":"University of Colorado, Denver","sponsor_type":"Other","conditions":"Solid Tumor, Adult","interventions":[{"intervention_type":"Drug","name":"Drug: Dose Escalation of Durvalumab and Trabectedin","description":"There will be a fixed dosage of Durvalumab, 1125mg, given intravenously over 60 minutes on Day 2 every 21 days. There will be an increase in Trabectedin for each cohort, given through intravenous infusion over a 24 hour period on Day 1 every 21 days as an outpatient.\r\nCohort -1: Durvalumab 1125mg with Trabectedin 0.5mg/m2\r\nCohort 1: Durvalumab 1125mg with Trabectedin 0.75mg/m2\r\nCohort 2: Durvalumab 1125mg with Trabectedin 1.0mg/m2\r\nCohort 3: Durvalumab 1125mg with Trabectedin 1.2mg/m2\r\nCohort 4: Durvalumab 1125mg with Trabectedin 1.5mg/m2"},{"intervention_type":"Drug","name":"Drug: Dose Expansion of Durvalumab and Trabectedin","description":"There will be a fixed dosage of Durvalumab, 1125mg, given intravenously over 60 minutes on Day 2 every 21 days. There will be a fixed dosage of Trabectedin for each cohort, whatever was determined to be the safest dose during the Dose Escalation Phase, and it will be given through intravenous infusion over a 24 hour period on Day 1 every 21 days as an outpatient."}],"outcomes":[{"outcome_type":"primary","measure":"Recommended Dosage of the Durvalumab and Trabectedin Combination","time_frame":"Up to 1 year on study treatment plus 90 days safety follow-up, up to 15 months","description":"Recommended Phase II Dose (RP2D) is the dose determined safest for further evaluation based on both early and late onset side effects detected during the dose escalation phase."},{"outcome_type":"primary","measure":"Maximum tolerated dose","time_frame":"First 2 cycles at 21 days each, equal to 42 days.","description":"Maximum Tolerated Dose (MTD) is defined as the highest dose level with no more than 1 Dose Limiting Toxicity (DLT) reported out of up to 6 DLT-evaluable subjects determined during the dose escalation phase"},{"outcome_type":"secondary","measure":"Overall Response Rate (ORR) of the Durvalumab and Trabectedin Combination in the whole treated population and at the RP2D in the expansion cohort(s)","time_frame":"After 2 cycles of study drugs to study end date, up to 24 months.","description":"ORR is determined by RECIST v1.1 and iRECIST response criteria."},{"outcome_type":"secondary","measure":"Duration of Response (DOR) of the Durvalumab and Trabectedin Combination","time_frame":"After 2 cycles of study drugs, up to 24 months.","description":"The time period for which a partial response (PR) or complete response (CR) is maintained."},{"outcome_type":"secondary","measure":"Clinical Benefit Rate (CBR) of the Durvalumab and Trabectedin Combination","time_frame":"After 2 cycles of study drugs to study end date, up to 24 months.","description":"Determined by complete response, partial response, or stable disease."},{"outcome_type":"secondary","measure":"One Year Progression Free Survival (PFS) of the Durvalumab and Trabectedin Combination","time_frame":"Study start date to progression, or death, whichever comes first, up to 24 months.","description":"PFS is determined by RECIST v1.1 and iRECIST"},{"outcome_type":"secondary","measure":"One Year Overall Survival (OS) of the Durvalumab and Trabectedin Combination","time_frame":"Study start date to death from any cause, up to 24 months.","description":"Determined continuously throughout the study."},{"outcome_type":"secondary","measure":"Incidence of Treatment-Emergent Adverse Events (Safety)","time_frame":"Study start date to study end date, up to 24 months.","description":"Number of participants with abnormal laboratory values and/or adverse events that are related to treatment."},{"outcome_type":"secondary","measure":"Incidence of Treatment-Emergent Adverse Events (Tolerability)","time_frame":"Study start date to study end date, up to 24 months.","description":"Number of participants with abnormal laboratory values and/or adverse events that are related to treatment."}]}
{"nct_id":"NCT03747159","start_date":"2018-10-01","phase":"Phase 2","enrollment":70,"brief_title":"Synergetic B-cell Immunomodulation in SLE - 2nd Study.","official_title":"A Randomized Trial to Investigate the Reset of Humoral Autoimmunity by Combining Belimumab With Rituximab in Severe Systemic Lupus Erythematosus","primary_completion_date":"2023-09-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2025-09-30","last_update":"2021-02-25","description":"In follow-up of the previous SynBioSe Study the present study is a randomized controlled trial designed to further investigate the long-term clinical and imunological efficacy of combination B-cell targeting by starting treatment with belimumab (anti-BAFF) followed by rituximab(anti-CD20) in lupus nephritis patients.","other_id":"NL65720.058.18","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Multi-center","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Have a clinical diagnosis of SLE according to the SLICC criteria 2012\r\n\r\n          2. Severe, active SLE disease defined as a situation in which 1 or more of the following\r\n             criteria are met:\r\n\r\n               1. SLEDAI-2K (SLE Disease Activity Index) with 12 or more points\r\n\r\n               2. New or worse SLE-related activity of major organs, i.e.: CNS-SLE (includes\r\n                  NPSLE), vasculitis, nephritis, pericarditis and/or myocarditis, myositis,\r\n                  thrombocytopenia < 60, hemolytic anemia < 4.4mmol/L (=7.0g/dL)\r\n\r\n               3. high disease activity that requires or warrants induction treatment by switching\r\n                  to or increasing dosage of oral mycophenolate\r\n\r\n          3. New, persisting or progressive disease activity despite the use of conventional\r\n             maintenance immunosuppressive treatment (e.g. mycophenolate or azathioprine)\r\n\r\n          4. Positive for relevant SLE-specific autoantibodies defined as a situation in which 1 or\r\n             more of the following criteria are met:\r\n\r\n               1. ANA seropositivity, as defined by a positive ANA-titer  1:80, before and at\r\n                  screening :\r\n\r\n                    -  Positive test results from 2 independent time points within the study\r\n                       screening period; OR\r\n\r\n                    -  One positive historical test result and 1 positive result during the\r\n                       screening period. Historical documentation of a positive test of ANA (eg,\r\n                       ANA by HEp-2 titer, ANA by ELISA) must include the date of the test.\r\n\r\n               2. Anti-DNA seropositivity, as defined by a positive anti-dsDNA serum antibody  30\r\n                  IU/mL, before and at screening:\r\n\r\n                    -  Positive test results from 2 independent time points within the study\r\n                       screening period.\r\n\r\n                    -  One positive historical test result and 1 positive result during the\r\n                       screening period. Historical documentation of a positive test of anti-dsDNA\r\n                       (eg, anti-dsDNA by Farr assay or ELISA) must include the date of the test.\r\n\r\n          5. Female subjects are eligible to enter the study if she is:\r\n\r\n               -  Not pregnant or nursing\r\n\r\n               -  Of non-child-bearing potential (i.e. after hysterectomy, postmenopausal,\r\n                  bilateral ovariectomy or documented bilateral tubal ligation or other permanent\r\n                  female sterilization procedure)\r\n\r\n               -  in agreement to not become pregnant (if female subjects of childbearing\r\n                  potential) and therefore must be sexually inactive by abstinence or use\r\n                  contraceptive methods with a failure rate of < 1%.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Active pregnancy, as proven by a positive urine beta-HCG test or a positive serum\r\n             beta-HCG\r\n\r\n          2. Significant hypogammaglobulinemia (IgG < 4.0 g/L) or an IgA deficiency (IgA < 0.1 g/L)\r\n\r\n          3. Immunization with a live vaccine 1 month before screening\r\n\r\n          4. Active infection at time of screening, as follows:\r\n\r\n               -  Hospitalization for treatment of infection within previous 60 days of day 0 of\r\n                  the study\r\n\r\n               -  Use of parenteral (intravenous of intramuscular) antibiotics (including\r\n                  anti-bacterials, anti-virals, anti-fungals or anti-parasitic agents) within\r\n                  previous 60 days of day 0 of the study\r\n\r\n               -  Serological evidence of viral hepatitis defined as: patients positive for HbsAg\r\n                  test or HBcAb or a positive hepatitis C antibody not treated with antiviral\r\n                  medication\r\n\r\n          5. Have a historically positive HIV test or test positive at screening for HIV\r\n\r\n          6. Have a history of a primary immunodeficiency\r\n\r\n          7. Have a neutrophil count of < 1.5x10E9/L\r\n\r\n          8. Have a significant infection history that in the opinion of the investigator would\r\n             make the candidate unsuitable for the study\r\n\r\n          9. Have a history of an anaphylactic reaction to parenteral administration of contrast\r\n             agents, human or murine proteins or monoclonal antibodies\r\n\r\n         10. Have any other clinically significant abnormal laboratory value in the opinion of the\r\n             investigator\r\n\r\n         11. Have current drugs or alcohol abuse or dependence within 365 days prior to Day 0 of\r\n             the study\r\n\r\n         12. Have an active malignant neoplasm or one in the history of the last 5 years, except\r\n             basal cell or squamous cell carcinoma of the skin treated with local resection only or\r\n             carcinoma in situ of the uterine cervix treated locally and with no evidence of\r\n             metastatic disease for 3 years\r\n\r\n         13. Have evidence of serious suicide risk including any history of suicidal behavior in\r\n             the last 6 months and/or any suicidal ideation in the last 2 months or who, in the\r\n             investigator's opinion, poses a significant suicide risk\r\n\r\n         14. Have any other clinically significant abnormal laboratory value, any intercurrent\r\n             significant medical or psychiatric illness that in the opinion of the investigator\r\n             would make the candidate unsuitable for the study\r\n      ","sponsor":"Leiden University Medical Center","sponsor_type":"Other","conditions":"Lupus Erythematosus, Systemic","interventions":[{"intervention_type":"Drug","name":"Drug: Belimumab Injection","description":"Weekly injection of belimumab prior to two infusions of rituximab with continuation of the belimumab as maintenance therapy"}],"outcomes":[{"outcome_type":"primary","measure":"Treatment failure rate","time_frame":"104 weeks","description":"The treatment failure rate will be measured at 104 weeks in both treatment arms with the hypothesis that lower treatment failure rates will be obtained in the RTX+BLM arm."},{"outcome_type":"secondary","measure":"Change of disease relevant auto-antibodies present at baseline, in particular anti-dsDNA","time_frame":"28 weeks","description":"All disease relevant auto-antibodies will be measured at 28 weeks and compared to baseline with the hypothesis that a better reduction will be obtained in the RTX+BLM arm."},{"outcome_type":"secondary","measure":"Sustained change of autoantibody production","time_frame":"100 weeks","description":"The sustained reduction of pathogenic autoantibodies, in particular anti-dsDNA autoantibodies"},{"outcome_type":"secondary","measure":"Seroconversion of disease relevant auto-antibodies","time_frame":"100 weeks","description":"Seroconversion of pathogenic autoantibodies, in particular anti-dsDNA autoantibodies"},{"outcome_type":"secondary","measure":"Change of memory B-cell numbers","time_frame":"28 weeks","description":"The detection of (autoreactive) memory B-cells by standardized flowcytometry and in B-cell culture assays"},{"outcome_type":"secondary","measure":"Sustained change of memory B-cell numbers","time_frame":"100 weeks","description":"The detection of (autoreactive) memory B-cells by standardized flowcytometry and in B-cell culture assays"},{"outcome_type":"secondary","measure":"Change of immune complex-mediated excessive neutrophil extracellular traps (NET) formation","time_frame":"28 weeks","description":"The quantification of ex vivo NET induction with a 3-dimensional, confocal microscopy technique"},{"outcome_type":"secondary","measure":"Sustained change of immune complex-mediated excessive neutrophil extracellular traps (NET) formation","time_frame":"100 weeks","description":"The quantification of ex vivo NET induction with a 3-dimensional, confocal microscopy technique"},{"outcome_type":"secondary","measure":"Evaluation of the clinical response","time_frame":"100 weeks","description":"The number of partial and complete renal responders in case of lupus nephritis"},{"outcome_type":"secondary","measure":"Evaluation of the clinical response by SLEDAI","time_frame":"100 weeks","description":"Patients will be monitored at frequent timepoints by the The Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), with a minimum score of 0 and a maximum score of 105, with a higher score indicating a higher disease activity"},{"outcome_type":"secondary","measure":"Evaluation of the clinical response by SLICC","time_frame":"100 weeks","description":"SLICC damage score (System Lupus International Collaborating Clinics/American College of Rheumatology Damage Index for Systemic Lupus Erythematosus) will be assesed at baseline, one year and two years, with a minimum score of 0 and a maximum score of 47, with a higher score indicating more damage"},{"outcome_type":"secondary","measure":"Evaluation of the clinical response by QoL questionnaires","time_frame":"100 weeks","description":"QoL questionnaires will be assessed at multiple time points by the SF-36 (ShortForm-36) questionnaire, with a minimum score of 0 and a maximum score of 100, with a higher score indicating a higher quality of life"},{"outcome_type":"secondary","measure":"Evaluation of the clinical response by the amount of moderate and severe flares.","time_frame":"100 weeks","description":"Patients will be monitored at frequent timepoint"},{"outcome_type":"secondary","measure":"Evaluation of the clinical response by the ability to reduce concomitant immunosuppression without flares","time_frame":"100 weeks","description":"Patients will be monitored at frequent timepoint"},{"outcome_type":"secondary","measure":"Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]","time_frame":"100 weeks","description":"Patients will be monitored at frequent timepoint"}]}
{"nct_id":"NCT03842475","start_date":"2018-10-01","enrollment":210,"brief_title":"Who Will Benefit From Bariatric Surgery for Diabetes?","official_title":"Who Will Benefit From Bariatric Surgery for Diabetes? Using Fat Distribution Measurement, Gut Hormone Profiles and Genetic Data to Predict Diabetes Remission","primary_completion_date":"2021-12-01","study_type":"Observational","rec_status":"Recruiting","completion_date":"2028-06-05","last_update":"2019-02-15","description":"A study investigating the influence of fat distribution, genetic susceptibility markers for type 2 diabetes (T2DM) and fat distribution, epigenetic and transcriptomic changes and gut hormone responses to a mixed meal on diabetes remission following bariatric surgery.","other_id":"IRAS:231300","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":80,"population":"Up to 150 patients recruited to completion from Imperial Weight Centre. Up to 60 healthy\r\n        volunteers","criteria":"\n        Bariatric surgery group\r\n\r\n        Inclusion Criteria:\r\n\r\n          -  Males and females planning to undergo RYGB\r\n\r\n          -  18-80 years\r\n\r\n          -  Type 2 diabetes mellitus or prediabetes\r\n\r\n          -  Stable weight for at least 3 months\r\n\r\n          -  Obese (BMI 30kg/m2)\r\n\r\n          -  Eligible for surgery on the National Health Service (NHS) under The National Institute\r\n             for Health and Care Excellence (NICE) 2014 criteria\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Current pregnancy\r\n\r\n          -  Inability to give informed consent\r\n\r\n          -  Type 1 diabetes\r\n\r\n          -  Low fasting C-peptide\r\n\r\n          -  Secondary diabetes or absence of -cell function\r\n\r\n          -  Unable to undergo DEXA, cirrhosis, ascites, or other condition that may modify body\r\n             fat composition e.g. underlying malignancy\r\n\r\n          -  Current smoker\r\n\r\n          -  Participation in another (interventional) trial within the last 3 months\r\n\r\n          -  Unable to understand English\r\n\r\n        Healthy volunteers\r\n\r\n        Inclusion criteria:\r\n\r\n          -  Aged 18-80 years\r\n\r\n          -  Male or female\r\n\r\n          -  Body mass index 19 - 25 kg/m2\r\n\r\n          -  Stable weight for at least three months\r\n\r\n        Exclusion criteria:\r\n\r\n          -  Abnormal glucose tolerance and fasting glucose\r\n\r\n          -  History of any medical, or other condition, or use of any medications, including\r\n             over-the-counter products, which, in the opinion of the investigators, would either\r\n             interfere with the study\r\n\r\n          -  Without access at home to a telephone, or other factor likely to interfere with\r\n             ability to participate reliably in the study\r\n\r\n          -  Pregnancy or breastfeeding\r\n\r\n          -  Unable to maintain adequate contraception for the duration of the study\r\n\r\n          -  Donated blood during the preceding 3 months or intention to do so before the end of\r\n             the study\r\n\r\n          -  Current smoker\r\n\r\n          -  Participation in another trial within the last 3 months\r\n\r\n          -  Unable to understand English\r\n      ","sponsor":"Imperial College London","sponsor_type":"Other","conditions":"Diabetes Mellitus, Type 2|Obesity","interventions":[{"intervention_type":"Procedure","name":"Procedure: Roux-en-Y gastric bypass (RYGB)","description":"Bariatric surgery"}],"outcomes":[{"outcome_type":"other","measure":"Changes in the transcriptome in tissues","time_frame":"1 year"},{"outcome_type":"other","measure":"Changes in gut hormone profiles","time_frame":"1 year"},{"outcome_type":"other","measure":"Histological scoring of specimens for Non-alcoholic fatty liver disease/Non-alcoholic steatohepatitis","time_frame":"1 year"},{"outcome_type":"other","measure":"Changes in gut microbiome","time_frame":"1 year"},{"outcome_type":"other","measure":"Change in epigenetic data in tissues.","time_frame":"1 year"},{"outcome_type":"primary","measure":"Diabetes remission (partial or complete)","time_frame":"1 year"},{"outcome_type":"primary","measure":"Diabetes remission (complete)","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Waist circumference, waist/hip ratio (cm)","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Body mass index (kg/m2)","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Weight loss","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Change in visceral adipose tissue","time_frame":"1 year","description":"Dual Energy Xray Absorptiometry measurement (DEXA)"},{"outcome_type":"secondary","measure":"Change in visceral adipose tissue","time_frame":"1 year","description":"Magnetic resonance imaging (MRI) measurement"},{"outcome_type":"secondary","measure":"Change in ectopic fat","time_frame":"1 year","description":"MRI measurement"}]}
{"nct_id":"NCT03701945","start_date":"2018-10-01","phase":"N/A","enrollment":156,"brief_title":"Pulmonary Rehabilitation Innovation and Microbiota in Exacerbations of COPD","official_title":"Pulmonary Rehabilitation Innovation and Microbiota in Exacerbations of COPD","primary_completion_date":"2021-06-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-06-30","last_update":"2020-07-08","description":"PRIME goal is to early detect and treat acute exacerbations of chronic obstructive pulmonary disease (AECOPD). This is important since COPD accelerates aging and represents major burden worldwide and in Portugal, mainly due to its frequent AECOPD. Pulmonary rehabilitation (PR) is an effective strategy of its management but it is scarce. When AECOPD are early detected and treated, it optimizes patients' outcomes and reduces the burden of COPD, especially if PR is used. However, up to date, there is no model to predict AECOPD for clinical practice. The lung microbiota shows promise to overcome this barrier and inform on COPD trajectory and will be investigated. In addition, despite of most AECOPD being managed in the community, PR is mainly available in hospitals and less than 1% of patients are having access. Thus, community-based PR will be implemented and a clinical decision tool developed for prioritizing who will most benefit from PR, enhancing evidence-based access to PR.","other_id":"POCI-01-0145-FEDER-028806","intervention_model":"Sequential Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"156 patients with COPD will be followed monthly for a year and their lung microbiota and clinical data will be analysed. Community-based PR will be delivered to 56 patients. Data will be collected before, at 3 weeks, after PR and at 6 months to assess the feasibility and effects of PR.","sampling_method":"","gender":"All","minimum_age":30,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients are eligible if adults (18anos) and present a diagnose of chronic\r\n             obstructive pulmonary disease (COPD).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients will be excluded if they had an acute cardiovascular event on the previous\r\n             month or if they have a significant cardiac, immune, musculoskeletal or neurological\r\n             impairment, or any other that doesn't allow them to perform tests.\r\n      ","sponsor":"Aveiro University","sponsor_type":"Other","conditions":"COPD Exacerbation|COPD","interventions":[{"intervention_type":"Other","name":"Other: Pulmonary rehabilitation","description":"Pulmonary rehabilitation will be provided to patients presenting an acute exacerbation. The intervention will be composed of exercise training, education and psychosocial support."}],"outcomes":[{"outcome_type":"primary","measure":"Change in lung microbiota","time_frame":"Up to 6 months","description":"lung microbiota from saliva samples"},{"outcome_type":"secondary","measure":"Change in muscle strength","time_frame":"Up to 6 months","description":"Upper and lower limb muscle strength"},{"outcome_type":"primary","measure":"Change in exercise tolerance","time_frame":"Up to 6 months","description":"exercise tolerance in a walking field test"},{"outcome_type":"secondary","measure":"Change in health related Quality of life","time_frame":"Up to 6 months","description":"Measured with the St. George's Respiratory Questionnaire, that measures health related quality of life. It will be used the total score. Scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status."},{"outcome_type":"secondary","measure":"Change in resting dyspnoea","time_frame":"Up to 6 months","description":"Resting dyspnoea measured with the modified British medical research council dyspnoea questionnaire, that ranges from 0 to 4, and is related to dyspnoea during activities of daily living. Higher scores demonstrate a higher functional impairment due to dyspnoea."},{"outcome_type":"secondary","measure":"Change in self-efficacy","time_frame":"Up to 6 months","description":"self-efficacy measured with the pulmonary rehabilitation adapted index of self-efficacy tool"},{"outcome_type":"secondary","measure":"Change in physical activity","time_frame":"Up to 6 months","description":"Physical activity levels measured with the brief physical activity assessment tool"},{"outcome_type":"secondary","measure":"Change in lung function","time_frame":"Up to 6 months","description":"Lung function will be assessed through spirometry to define the airflow limitation (FEV1pp)."},{"outcome_type":"secondary","measure":"Change in emergency department visits","time_frame":"Up to 6 months","description":"Number of emergency visits on the previous year"},{"outcome_type":"secondary","measure":"Change in frequency of exacerbations","time_frame":"Up to 6 months","description":"Number of exacerbations on previous year"},{"outcome_type":"secondary","measure":"Change in hospitalizations","time_frame":"Up to 6 months","description":"Number of hospitalizations on previous year"},{"outcome_type":"secondary","measure":"Dyspnoea during exercise","time_frame":"Up to 6 months","description":"Dyspnoea experienced during exercise, monitored with the modified Borg dyspnoea scale, that ranges from 0 to 10, where 0 represents no dyspnoea and 10 the worst imaginable dyspnoea."},{"outcome_type":"secondary","measure":"Fatigue during exercise","time_frame":"Up to 6 months","description":"Fatigue experienced during exercise, monitored with the modified Borg dyspnoea scale, that ranges from 0 to 10, where 0 represents no fatigue and 10 the worst fatigue the patient can imagine."}]}
{"nct_id":"NCT03582891","start_date":"2018-10-01","phase":"N/A","enrollment":25,"brief_title":"The Motor Network in Parkinson's Disease and Dystonia: Mechanisms of Therapy","official_title":"Closed Loop Deep Brain Stimulation in Parkinson's Disease and Dystonia (Activa RC+S)","primary_completion_date":"2025-07-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2028-03-31","last_update":"2021-08-17","description":"This is an exploratory pilot study to identify neural correlates of specific motor signs in Parkinson's disease (PD) and dystonia, using a novel totally implanted neural interface that senses brain activity as well as delivering therapeutic stimulation. Parkinson's disease and isolated dystonia patients will be implanted unilaterally or bilaterally with a totally internalized bidirectional neural interface, Medtronic Summit RC+S. This study includes three populations: ten PD patients undergoing deep brain stimulation in the subthalamic nucleus (STN), ten PD patients with a globus pallidus (GPi) target and five dystonia patients. All groups will test a variety of strategies for feedback-controlled deep brain stimulation, and all patients will undergo a blinded, small pilot clinical trial of closed-loop stimulation for thirty days.","other_id":"UCSF Summit RC+S","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Double","intervention_model_description":"Investigators will run a pilot clinical trial in which individualized classifier/control strategies for each hemisphere in each subject will be embedded within the RC+S for a total of one month (x4 one week blocks) of feedback-controlled stimulation will be compared with a total of one month of empirically optimized open-loop stimulation, (x4 one week blocks), administered in randomized order with adaptive stimulation. During these 1-month trials, patients and neurologists will be blinded to the state of the stimulator.","sampling_method":"","gender":"All","minimum_age":21,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria\r\n\r\n        Parkinson's Disease:\r\n\r\n          1. Ability to give informed consent for the study\r\n\r\n          2. Movement disorder symptoms that are sufficiently severe, in spite of best medical\r\n             therapy, to warrant surgical implantation of deep brain stimulators according to\r\n             standard clinical criteria\r\n\r\n          3. Patient has requested surgical intervention with deep brain stimulation for their\r\n             disorder\r\n\r\n          4. No MR abnormalities that suggest an alternative diagnosis or contraindicate surgery\r\n\r\n          5. Absence of significant cognitive impairment (score of 20 or greater on the Montreal\r\n             Cognitive Assessment (MoCA),\r\n\r\n          6. Signed informed consent\r\n\r\n          7. Ability to comply with study follow-up visits for brain recording, testing of adaptive\r\n             stimulation, and clinical assessment.\r\n\r\n          8. Age 21-75 (for STN patients, minimum age is 25)\r\n\r\n          9. Diagnosis of idiopathic PD with duration of motor symptoms for 4 years or greater\r\n\r\n         10. Patient has undergone appropriate therapy with oral medications with inadequate relief\r\n             as determined by a movement disorders neurologist, and has had stable doses of\r\n             antiparkinsonian medications for 30 days prior to baseline assessment.\r\n\r\n         11. UPDRS-III score off medication between 20 and 80 and an improvement of at least 30% in\r\n             the baseline UPDRS-III on medication score, compared to the baseline off-medication\r\n             score, and motor fluctuations with at least 2 hours per day of on time without\r\n             dyskinesia or with non-bothersome dyskinesia.\r\n\r\n        OR Patients with tremor-dominant PD (a tremor score of at least 2 on a UPDRS-III sub-score\r\n        for tremor), treatment resistant, with significant functional disability despite maximal\r\n        medical management\r\n\r\n        Dystonia:\r\n\r\n          1. Ability to give informed consent for the study\r\n\r\n          2. Movement disorder symptoms that are sufficiently severe, in spite of best medical\r\n             therapy, to warrant surgical implantation of deep brain stimulators according to\r\n             standard clinical criteria\r\n\r\n          3. Patient has requested surgical intervention with deep brain stimulation for their\r\n             disorder\r\n\r\n          4. No MR abnormalities that suggest an alternative diagnosis or contraindicate surgery\r\n\r\n          5. Absence of significant cognitive impairment (score of 20 or greater on the Montreal\r\n             Cognitive Assessment (MoCA)\r\n\r\n          6. Signed informed consent\r\n\r\n          7. Ability to comply with study follow-up visits for brain recording, testing of adaptive\r\n             stimulation, and clinical assessment.\r\n\r\n          8. Age 21-75\r\n\r\n          9. Diagnosis of Isolated dystonia, which may be focal cervical, segmental craniocervical,\r\n             or generalized forms.\r\n\r\n         10. Stable doses of anti-dystonia medications (such as trihexyphenydil, Baclofen, or\r\n             clonazepam) for at least 30 days prior to baseline assessment\r\n\r\n         11. For dystonia patients with craniofacial and cervical involvement, prior treatment with\r\n             botulinum toxin with failure to adequately control dystonia symptoms.\r\n\r\n        Exclusion Criteria\r\n\r\n        Parkinson's Disease:\r\n\r\n          1. Coagulopathy, anticoagulant medications, uncontrolled hypertension, history of\r\n             seizures, heart disease, or other medical conditions considered to place the patient\r\n             at elevated risk for surgical complications\r\n\r\n          2. Evidence of a psychogenic movement disorder: Motor symptoms that remit with suggestion\r\n             or \"while unobserved\", symptoms that are inconsistent over time or incongruent with\r\n             clinical condition, plus other manifestation such as \"false\" signs, multiple\r\n             somatizations, or obvious psychiatric disturbance.\r\n\r\n          3. Pregnancy: all women of child bearing potential will have a negative urine pregnancy\r\n             test prior to undergoing their surgical procedure.\r\n\r\n          4. Significant untreated depression (BDI-II score >20) History of suicidal attempt or\r\n             active suicidal ideation (Yes to #2-5 on C-SSRS)\r\n\r\n          5. Any personality or mood symptoms that study personnel believe will interfere with\r\n             study requirements.\r\n\r\n          6. Subjects who require ECT, rTMS or diathermy\r\n\r\n          7. Implanted stimulation systems such as; cochlear implant, pacemaker, defibrillator,\r\n             neurostimulator or metallic implant\r\n\r\n          8. Previous cranial surgery\r\n\r\n          9. Drug or alcohol abuse\r\n\r\n         10. Meets criteria for Parkinson's disease with mild cognitive impairment (PD-MCI). These\r\n             criteria are: performance of more than two standard deviations below appropriate\r\n             norms, for tests from two or more of these five cognitive domains: attention,\r\n             executive function, language, memory, and visuospatial tests.\r\n\r\n        Dystonia:\r\n\r\n          1. Coagulopathy, anticoagulant medications, uncontrolled hypertension, history of\r\n             seizures, heart disease, or other medical conditions considered to place the patient\r\n             at elevated risk for surgical complications\r\n\r\n          2. Evidence of a psychogenic movement disorder: Motor symptoms that remit with suggestion\r\n             or \"while unobserved\", symptoms that are inconsistent over time or incongruent with\r\n             clinical condition, plus other manifestation such as \"false\" signs, multiple\r\n             somatizations, or obvious psychiatric disturbance.\r\n\r\n          3. Pregnancy: all women of child bearing potential will have a negative urine pregnancy\r\n             test prior to undergoing their surgical procedure.\r\n\r\n          4. Significant untreated depression (BDI-II score >20) History of suicidal attempt or\r\n             active suicidal ideation (Yes to #2-5 on C-SSRS)\r\n\r\n          5. Any personality or mood symptoms that study personnel believe will interfere with\r\n             study requirements.\r\n\r\n          6. Subjects who require ECT, rTMS or diathermy\r\n\r\n          7. Implanted stimulation systems such as; cochlear implant, pacemaker, defibrillator,\r\n             neurostimulator or metallic implant\r\n\r\n          8. Previous cranial surgery\r\n\r\n          9. Drug or alcohol abuse\r\n      ","sponsor":"University of California, San Francisco","sponsor_type":"Other","conditions":"Dystonia|Parkinson Disease","interventions":[{"intervention_type":"Device","name":"Device: Summit RC+S for Motor","description":"Using the RC+S pulse generator, investigators will measure cortical biomarkers of hyper and hypokinesia in Parkinson's and dystonia patients to develop an adaptive algorithm which adjusts the level of deep brain stimulation needed based upon the patient's physiology."},{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: 8-week pilot trial of Closed-loop vs. Open-loop Stimulation","description":"These patients will participate in an 8 week clinical trial of open loop versus adaptive mode (4 weeks for each mode (interleaved), with the order counterbalanced across subjects )."},{"intervention_type":"Device","name":"Device: Summit RC+S for Sleep","description":"Using the RC+S pulse generator, investigators will measure cortical biomarkers of sleep stages in Parkinson's patients to develop an adaptive algorithm which adjusts the level of deep brain stimulation needed based upon the patient's physiology."}],"outcomes":[{"outcome_type":"primary","measure":"Duration of 'on' stimulation time without dyskinesia from motor diaries in adaptive compared to standard open loop stimulation. (Parkinson's disease patients)","time_frame":"Comparison will use data from the testing of open and closed-loop stimulation during chronic adaptive DBS testing at home.","description":"Duration of 'on' stimulation time without dyskinesia in adaptive compared to standard open loop stimulation determined from the patients' motor diaries. The self-report motor diary is a validated method to capture this information. Every half-hour, patients indicate in this diary which of 4 categories (on, on with troubling dyskinesia, off, or asleep) best reflected their predominant symptoms for the prior 30 minutes. Patients will complete this diary for 3 consecutive days. The total time spent in the 'on' state without troubling dyskinesia will then be summed and averaged over 3 days for all three conditions (baseline, open-loop stimulation and closed-loop stimulation)."},{"outcome_type":"primary","measure":"The Burke-Fahn-Marsden Dystonia Rating Scale-Movement aDBS testing compared to pre-operative baseline(Dystonia Patients)","time_frame":"Comparison will use data from the testing of open and closed-loop stimulation during chronic adaptive DBS testing at home.","description":"This scales evaluates dystonia in nine body areas, including eyes, mouth, speech and swallowing, neck, trunk, and right and left arm and leg. The maximal total score is 120 - a higher score means worsening symptoms. Investigators will compare the dystonia symptoms and functional disability during adaptive stimulation compared to preoperative baseline."},{"outcome_type":"primary","measure":"Toronto Western Spasmodic Torticollis Rating Scale during aDBS testing compared to pre-operative baseline (Dystonia Patients)","time_frame":"Comparison will use data from the testing of open and closed-loop stimulation during chronic adaptive DBS testing at home.","description":"This is a standardized scale to measure the severity, disability, and pain associated with cervical dystonia. The motor severity subscale consists of 10 items, with variable scaling and weighting. It also includes a disability scale with six items,and a pain scale with three items. The total score is the sum of each of the subscales. A higher score indicates greater disability."},{"outcome_type":"primary","measure":"Karolinska Sleepiness Scale","time_frame":"Through study completion, up to 4 years","description":"This is a standardized scale for measuring sleepiness"},{"outcome_type":"primary","measure":"Psychomotor vigilance task (PVT)","time_frame":"Through study completion, up to 4 years","description":"This is a standardized behavioral task for measure alertness and attention"},{"outcome_type":"primary","measure":"Positive and Negative Affect Schedule (PANAS-SF)","time_frame":"Through study completion, up to 4 years","description":"This is a standardized mood questionnaire"},{"outcome_type":"secondary","measure":"The Unified Parkinsons Disease Rating Scale (UPDRS) III scores off of medication in adaptive compared to standard open-loop stimulation. (Parkinson's disease patients)","time_frame":"Comparison will use data from the testing of open and closed-loop stimulation during chronic adaptive DBS testing at home.","description":"The UPDRS III is a motor rating scale. Investigators will compare the severity motor symptoms while the patient is off of Parkinsoniae (UPDRS) III scores off of medication in adaptive compared to standard open-loop stimulation. (Parkinson's disease patients)n medications in conventional (open-loop) versus adaptive (closed-loop) DBS."},{"outcome_type":"secondary","measure":"Schwab England scale in adaptive compared to standard open loop stimulation. (Parkinson's disease patients)","time_frame":"Comparison will use data from the testing of open and closed-loop stimulation during chronic adaptive DBS testing at home.","description":"This scale estimates the abilities of individuals living with Parkinson's Disease relative to a completely independent situation. Investigators will use it to compare the abilities of daily living in subjects during the open-loop and adaptive stimulation trial."},{"outcome_type":"secondary","measure":"Hoehn and Yahr Staging in the medication 'on' state in adaptive compared to standard open loop stimulation. (Parkinson's disease patients)","time_frame":"Comparison will use data from the testing of open and closed-loop stimulation during chronic adaptive DBS testing at home.","description":"The Hoehn and Yahr scale are used to describe the progression of Parkinson's disease based upon the level of motor impairment. This scale only includes one score ranging from 1 to 5 where a higher score indicates a higher level of motor impairment. Investigators will compare the level of disease progression between the open-loop and adaptive stimulation conditions."},{"outcome_type":"secondary","measure":"The patient' quality of life report (PDQ-39) in adaptive compared to standard open loop stimulation. The PDQ39 yields a score between 0 to 100, where a higher score indicates more health problems. (Parkinson's disease patients)","time_frame":"Comparison will use data from the testing of open and closed-loop stimulation during chronic adaptive DBS testing at home.","description":"The PDQ 39 questionnaire has 39 questions to assess the patient's life quality including mobility, emotional state, and bodily comfort. Investigators will make a comparison of patients' life quality of life between open-loop and adaptive stimulation."},{"outcome_type":"secondary","measure":"Patient's Global Impression of Change (PGIC) in adaptive compared to standard open loop stimulation. (Parkinson's disease patients)","time_frame":"Comparison will use data from the testing of open and closed-loop stimulation during chronic adaptive DBS testing at home.","description":"Patient Global Impression of Changes measures the self-reported level of overall improvement (motor and non-motor symptoms) in a patient on a 1-7 scale. A one indicates no change and a 7 is the greatest level of improvement."},{"outcome_type":"secondary","measure":"Total Electric Energy Delivered (TEED) by the pulse generator in adaptive compared to standard open loop stimulation. (all patients)","time_frame":"Comparison will use data from the testing of open and closed-loop stimulation during chronic adaptive DBS testing at home.","description":"Investigators will compare the total charge delivered by the pulse generator between open-loop and adaptive stimulation to determine if there is a potential energy savings."},{"outcome_type":"secondary","measure":"Short form 36 Quality of Life measure (Dystonia Patients)","time_frame":"Comparison will use data from the testing of open and closed-loop stimulation during chronic adaptive DBS testing at home.","description":"The SF-36 is a measure of self-reported health status which is scored on a 0-100 scale. The lower the score the more disability a patient experiences."},{"outcome_type":"secondary","measure":"Patient Global Impression of Change (Dystonia Patients)","time_frame":"Comparison will use data from the testing of open and closed-loop stimulation during chronic adaptive DBS testing at home.","description":"Patient Global Impression of Changes measures the self-reported level of overall improvement (motor and non-motor symptoms) in a patient on a 1-7 scale. A one indicates no change and a 7 is the greatest level of improvement."},{"outcome_type":"secondary","measure":"Resting state EEG Recording","time_frame":"Through study completion, up to 4 years","description":"Resting state cortical power will be analyzed as a surrogate marker of alertness"}]}
{"nct_id":"NCT04331522","start_date":"2018-10-01","enrollment":8000,"brief_title":"Allergen Provocations- HCA Children's Hospital","official_title":"Allergen Provocations at Hans Christian Andersen Children's Hospital","primary_completion_date":"2038-10-31","study_type":"Observational [Patient Registry]","rec_status":"Recruiting","completion_date":"2039-10-31","last_update":"2020-04-02","description":"A prospective study of all allergen provocations performed in children at the Hans Christian Andersen Children's Hospital.","other_id":"HCA-AP","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","maximum_age":18,"population":"Children referred to the department of pediatrics for investigation of allergy to foods or\r\n        antibiotics","criteria":"\n        Inclusion Criteria:\r\n\r\n        clinical suspicion of allergy to foods or antibiotics informed concent -\r\n\r\n        Exclusion Criteria:\r\n\r\n        -\r\n      ","sponsor":"Josefine Gradman","sponsor_type":"Other","conditions":"Allergy in Children","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Oral provocation test","description":"Titrated provocation with allergen"}],"outcomes":[{"outcome_type":"primary","measure":"The association of allergy tests with the result of allergen provocation","time_frame":"5 years","description":"The value of specific IgE and SPT to predict the outcome of a allergen provocation"}]}
{"nct_id":"NCT03544957","start_date":"2018-10-01","enrollment":199,"brief_title":"Evaluation of the Triage Risk Screening Tool","official_title":"Evaluation of the Triage Risk Screening Tool (TRST) as Screening Instrument Elderly Subject Fragility at the Accident and Emergency Department","primary_completion_date":"2019-01-01","study_type":"Observational","rec_status":"Completed","completion_date":"2019-04-01","last_update":"2019-08-28","description":"This study tried to describe diagnostic properties of TRST completed by an emergency doctor, for screening process for fragility of elderly subjects admitted at the accident and emergency department.","other_id":"2018-02Obs-CHRMT","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":75,"population":"Elderly subject admitted to the emergency department","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients who are more than 75 years old\r\n\r\n          -  Admitted to the emergency department for medical or surgical reason\r\n\r\n          -  Admitted from Monday to Friday (8h30 AM- 6h PM)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patient with specific care (vital emergency, urgent surgery)\r\n\r\n          -  Patient or his support person opposing the use of data\r\n      ","sponsor":"Centre Hospitalier Rgional Metz-Thionville","sponsor_type":"Other","conditions":"Elderly Subject Fragility","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"TRST-U","time_frame":"Day 1","description":"Triage Risk Screening Tool completed by an emergency doctor"},{"outcome_type":"secondary","measure":"TRST-G","time_frame":"Day 1","description":"Triage Risk Screening Tool completed by a geriatrician"},{"outcome_type":"secondary","measure":"SEGA instrument","time_frame":"Day 1","description":"Evaluation of TRST versus SEGA instrument (gold standard)"}]}
{"nct_id":"NCT03583879","start_date":"2018-09-28","phase":"N/A","enrollment":41,"brief_title":"Using Gait Robotics to Improve Symptoms of Parkinson's Disease","official_title":"Using Gait Robotics to Improve Symptoms of Parkinson's Disease","primary_completion_date":"2019-10-04","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-10-04","last_update":"2020-12-08","description":"This study evaluates the benefits of exoskeleton-based exercise for improving mood and cognition in people with Parkinson's disease (PD). Participants with PD will be assigned one of three treatments delivered over 8-weeks: exoskeleton exercise (experimental intervention), non-exoskeleton exercise (active comparator), and wait-list control (no treatment).","other_id":"KPD001","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":50,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Provision of signed and dated informed consent form\r\n\r\n          -  Stated willingness to comply with all study procedures and availability for the\r\n             duration of the study\r\n\r\n          -  Cognitive function score >=16 on Montreal Cognitive Assessment (MoCA)\r\n\r\n          -  Diagnosed with Parkinson's disease, Hoehn and Yahr stage 1 to 4\r\n\r\n          -  Able to walk 10 meters without stopping and without human assistance (using assistive\r\n             devices such as cane or walker if normally used)\r\n\r\n          -  Waist and leg circumference and lower extremity lengths appropriate for a comfortable\r\n             and safe fit in the KEEOGO device\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Legally blind\r\n\r\n          -  Treatment with another investigational drug or other intervention within the study\r\n             period\r\n\r\n          -  New medications started within last 4 weeks\r\n\r\n          -  Skin condition that contraindicates use of orthotics or support braces\r\n\r\n          -  Lower-extremity amputation above or below the knee\r\n\r\n          -  Uncontrolled orthostatic hypotension\r\n\r\n          -  Psychiatric disorders such as schizophrenia or bipolar disorder\r\n\r\n          -  Other diagnosis that impairs gait and balance, such as, but not limited to, chronic\r\n             obstructive pulmonary disease; peripheral arterial disease; vestibular disorders;\r\n             cerebellar disease; cerebral palsy; muscular dystrophy; spinal cord injury; stroke or\r\n             other brain injury; severe degenerative joint disease (osteoarthritis, rheumatoid\r\n             arthritis, etc.)\r\n      ","sponsor":"Baycrest","sponsor_type":"Other","conditions":"Dementia|Parkinson Disease|Mild Cognitive Impairment","interventions":[{"intervention_type":"Other","name":"Other: Exoskeleton exercise","description":"Functional exercise with a robotic exoskeleton"},{"intervention_type":"Other","name":"Other: Standard exercise","description":"Functional exercise without a robotic exoskeleton"},{"intervention_type":"Other","name":"Other: No treatment","description":"Wait-list control"}],"outcomes":[{"outcome_type":"primary","measure":"Change in cognitive function","time_frame":"Baseline and 8 weeks","description":"10-item \"Scales for Outcomes in Parkinson's-Cognition\" (SCOPA-COG) instrument to evaluate cognitive function; Total score, range 0-43, higher scores = better cognitive functioning."},{"outcome_type":"primary","measure":"Change in mood","time_frame":"Baseline and 8 weeks","description":"14-item \"Hospital Anxiety and Depression Scale\" (HADS) instrument to measure mood disorder; Total score, range 0-42, higher scores = more severe mood disorder"},{"outcome_type":"secondary","measure":"Change in UPDRS Mentation score","time_frame":"Baseline and 8 weeks","description":"\"Unified Parkinson's Disease Rating Scale\" (UPDRS), 4-item Section I - Mentation; Sub-scale score range 0-16, higher scores = worse symptoms."},{"outcome_type":"secondary","measure":"Change in UPDRS Motor score","time_frame":"Baseline and 8 weeks","description":"\"Unified Parkinson's Disease Rating Scale\" (UPDRS), 14-item Section III - Motor; Sub-scale range 0-108, higher scores = worse symptoms."},{"outcome_type":"secondary","measure":"Change in functional balance","time_frame":"Baseline and 8 weeks","description":"Brief version of Balance Evaluation Systems Test (Brief-BESTest) for balance, average of three tests."},{"outcome_type":"secondary","measure":"Change in self-report balance confidence (of not falling)","time_frame":"Baseline and 8 weeks","description":"16 item \"Activity-specific Balance Confidence\" (ABC) for balance self-efficacy; Total score, 0-100, is average of items scaled on 0-100% confidence in doing specific tasks without falling, higher scores = better balance confidence"},{"outcome_type":"secondary","measure":"Change in gait speed","time_frame":"Baseline and 8 weeks","description":"Fast walking gait speed, average of three tests."},{"outcome_type":"secondary","measure":"Change in dual-task gait cost index","time_frame":"Baseline and 8 weeks","description":"Dual-task gait cost index (DTGC); Calculated index score (0-1) based on ratio of gait speed during normal gait minus gait speed with cognitive distractor divided by normal gait speed, average of three tests."},{"outcome_type":"secondary","measure":"Change in dual-task cognitive cost index","time_frame":"Baseline and 8 weeks","description":"Dual-task cognitive cost index (DTCC); Calculated index score (0-1) based on ratio of correct responses during sitting minus correct responses during gait divided by correct responses while seated, average of three tests."},{"outcome_type":"secondary","measure":"Change in six minute walk test score","time_frame":"Baseline and 8 weeks","description":"Distance covered with 6 min walking, average of three tests"},{"outcome_type":"other","measure":"Change in freezing of gait episodes","time_frame":"Baseline and 8 weeks","description":"6-item \"Freezing of Gait Questionnaire\" (FoG-Q) for measuring the impact of freezing of gait on mobility; Total score, range 0-24, higher scores = worse symptoms."},{"outcome_type":"other","measure":"Change in physical function, pain, emotional well-being, and other indicators of health-related quality of life","time_frame":"Baseline and 8 weeks","description":"39-item \"Parkinson's Disease health-related Quality of life\" (PDQ-39) survey; Total score, 0-195, higher scores = worse health-related quality of life"},{"outcome_type":"other","measure":"Cumulative exercise dose","time_frame":"2x per week for 8 weeks","description":"Actigraph activity monitor for quantifying cumulative energy expenditure"}]}
{"nct_id":"NCT03662555","start_date":"2018-09-26","phase":"N/A","enrollment":50,"brief_title":"Effect of Neuromuscular Electrical Stimulation Combined With Blood Flow Restriction on Muscular and Cardiovascular Function","official_title":"Effect of Neuromuscular Electrical Stimulation Combined With Varying Degrees of Blood Flow Restriction on Muscular and Cardiovascular Function","primary_completion_date":"2019-07-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-09-30","last_update":"2018-09-12","description":"Neuromuscular electrical stimulation (NMES) has recently been combined with blood flow restriction (BFR) in controlled trials and has shown increased muscular strength and size compared with NMES and BFR on their own. However, none have used BFR pressures previously recommended. The first study of my Ph.D. found 40% and 80% BFR pressures to induce acute fatigue and muscle swelling. However, 80% caused higher ratings of pain and perceived exertion. The present study will determine whether NMES combined with either 40% or 80% BFR causes greater structural muscular adaptations and is perceptually easier after 6 weeks of training.","other_id":"Stmarys","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"In a multi-arm parallel randomised controlled trial design. The randomisation scheme will be generated via online software (http://www.randomization.com). Participants will be recruited to 6 weeks of training, 3 sessions a week and randomised to one of three groups.\r\nGroup 1, participants will undergo NMES and BFR (80% pressure) applied to the quadriceps for 25 min.\r\nGroup 2, participants will undergo NMES and BFR (40% pressure) applied to the quadriceps for 25 min.\r\nGroup 3, participants will undergo NMES alone (Control) applied to the quadriceps for 25 min.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy adults aged between 18 and 45 years old\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of lower extremity surgery, traumatic injuries to the ankle, knee, hip, pelvis\r\n             and lower back\r\n\r\n          -  Current musculoskeletal condition\r\n\r\n          -  High blood pressure\r\n\r\n          -  Cardiovascular pathology\r\n      ","sponsor":"St. Mary's University","sponsor_type":"Other","conditions":"Muscle Weakness|Muscle Atrophy","interventions":[{"intervention_type":"Device","name":"Device: Neuromuscular electrical stimulation","description":"Neuromuscular electrical simulation (NMES) Two self-adhesive electrodes (2 mm thick) will be placed over the rectus femoris, vastus medialis and vastus lateralis muscles. The electrodes will be placed on the motor points of each muscle. The stimulator discharges biphasic rectangular pulses. The stimulation frequency and duty cycle will be 50 Hz and 5 s of stimulation followed by a 5 s pause for each rep. The intensity of electrical flow will be at each subject's maximum that they can tolerate. The stimulation will be for 5 x 5 min sets with 1 min rest between sets.\r\nBlood flow restriction\r\nA handheld Doppler probe (Hi-Dop) will detect their auscultatory and visual pulse using the doppler's screen. The cuff will be inflated initially up to their systolic blood pressure and then incrementally by 10 mmHg until no auscultatory or visual pulse is detected. A percentage of 40% or 80% of each subject's LOP will then be used during the BFR conditions."}],"outcomes":[{"outcome_type":"primary","measure":"Quadriceps volume and muscle architecture (3D Ultrasound)","time_frame":"8 weeks","description":"Muscle volume of the vastus lateralis and skeletal muscle architecture will be assessed by ultrasound technique (Telemed LogicScan 128 EXT-1Z). Measurement of fascicle length and pennation angle will be acquired at mid-belly, in the mid-sagittal plane."},{"outcome_type":"primary","measure":"Knee extension isometric, eccentric, concentric and endurance strength (Cybex)","time_frame":"8 weeks","description":"Maximal isometric, eccentric and concentric strength of the quadricep muscles will be measured using the same isokinetic dynamometer to assess peak force measurements (Cybex). This digital strain gauge dynamometer displays the force measurement to the nearest 0.1 N. Prior to each measurement, the instrument will be calibrated per the manufacturer's instructions and specifications. The individuals will be seated in a comfortable position with the backrest angled at 100˚ to the seat without shoes or orthotic device on. Maximal voluntary isometric contraction (MVIC) for the quadriceps will tested at 60 degrees from full extension using a goniometer (19-21), and the shin pad positioned 2 cm above the lateral malleolus of the fibula attached to a load cell (22)."},{"outcome_type":"secondary","measure":"Voluntary activation","time_frame":"8 weeks","description":"The percent of voluntary activation (%VA) will be estimated using the twitch interpolation protocol (25). Doublet stimuli were administered to the femoral nerve approximately 200-300 ms into the MVC. A second doublet will be applied approximately 3 s after the cessation of the MVC at rest (25). The stimuli were rectangular pulses of 200 ls duration and will be delivered using a high-voltage (maximal voltage = 400 V) constant-current stimulator (Digitimer DS7AH, Herthfordshire, UK)."},{"outcome_type":"secondary","measure":"Near-infrared spectroscopy","time_frame":"8 weeks","description":"Following 10 min of supine rest a near-infrared spectroscopy (NIRS) optode (Portamon, Artinis medical systems) was placed on the vastus lateralis and secured with an elastic bandage (Tiger Tear, Hampshire, United Kingdom) to prevent movement and covered with an optically dense black material to minimize the intrusion of extraneous light. This protocol was used to characterize the recovery of m˙VO2 and has been shown to be reliable by our group and others (28-30). NIRS will be assessed PRE, MID and POST1, 2, 3 and 4."},{"outcome_type":"secondary","measure":"Blood pressure","time_frame":"8 weeks","description":"A blood pressure cuff (Omron) will be placed around the subject's dominant arm and tested after 5 mins of supine rest and then immediately post each intervention session and at POST testing. To assess acute changes in systolic and diastolic blood pressure. Two readings will be taken and if they have a difference of >5 a third reading will be taken and the average recorded (27)."}]}
{"nct_id":"NCT03440879","start_date":"2018-09-21","phase":"N/A","enrollment":40,"brief_title":"Androgen Deprivation Therapy Muscle Protein Metabolism and Blood Glucose","official_title":"The Effect of Androgen Deprivation Therapy on Regulation of Muscle Protein Metabolism and Blood Glucose","primary_completion_date":"2022-04-04","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-08-31","last_update":"2021-05-12","description":"Prostate cancer (PCa) patients receiving androgen deprivation therapy (ADT) (e.g., Zoladex), experience troublesome side effects during and after treatment (e.g., loss of lean body mass (LBM) and increased fat mass). Although the negative effects of ADT on muscle mass are well documented, the cellular effects of ADT on muscle tissue are still largely unknown, and studies investigating the mechanisms are highly warranted. Furthermore, understanding the cellular mechanisms through which ADT negatively influences muscle mass and glucose metabolism is important so that appropriate measures can be taken to counteract muscle wasting and comorbidities during ADT. Thus, PCa patients on ADT (Zoladex), along with non-ADT treated PCa patients serving as controls, will be invited to participate in this study, that aims to investigate the influence of ADT on the basal muscle protein turnover, as well as the responses to strength training. Secondary aims are to investigate between-group differences in blood glucose and insulin responses following a meal).","other_id":"PROST100","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion criteria\r\n\r\n        All of the following conditions must apply to the prospective patient at screening prior to\r\n        participation:\r\n\r\n          -  Histologically verified prostate cancer, and either currently on Zoladex or without\r\n             any current or no past usage of any ADT\r\n\r\n          -  Between 18 and 75 years of age\r\n\r\n          -  Capable of reading and understanding Norwegian, and able to provide informed consent\r\n\r\n          -  Treating oncologist/ study medical doctors (KMR) approval for participation\r\n\r\n          -  Signed informed consent must be obtained and documented according to Good Clinical\r\n             Practice (GCP), and national/local regulations.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Patients will be excluded from the study if they meet any of the following criteria:\r\n\r\n          -  Routine resistance training (>1 weekly session, last six months)\r\n\r\n          -  Treated with Warfarin, or if seponation of acetylsalicylic acid is not recommended\r\n\r\n          -  Conditions where heavy resistance exercise is contraindicated:\r\n\r\n               -  Unregulated hypertension\r\n\r\n               -  Unstable angina pectoris\r\n\r\n               -  Recent myocardial infarction (<1 year)\r\n\r\n               -  Cardiac arrhythmia\r\n\r\n               -  Chronic obstructive pulmonary disease\r\n\r\n               -  Severe asthma\r\n\r\n               -  Recent stroke (<1 year)\r\n\r\n               -  Epilepsy\r\n\r\n               -  Insulin-dependent diabetes mellitus\r\n\r\n               -  Unstable bone lesions with increased risk of fractures\r\n\r\n          -  Conditions where patients ability to complete the training sessions is challenged:\r\n\r\n               -  Uncontrolled pain\r\n\r\n               -  Severe arthritis\r\n\r\n               -  Scheduled hip or knee replacement\r\n\r\n               -  Pathologic fractures last six months\r\n\r\n               -  Amputations\r\n\r\n               -  Walker or wheelchair user\r\n\r\n          -  Mentally incompetent conditions:\r\n\r\n               -  Severe anxiety or depression\r\n\r\n               -  Dementia\r\n\r\n               -  Known alcoholism or substance abuse\r\n\r\n               -  Mentally retarded\r\n      ","sponsor":"Norwegian School of Sport Sciences","sponsor_type":"Other","conditions":"Prostate Cancer|Resistance Exercise|Androgen Deprivation Therapy","interventions":[{"intervention_type":"Drug","name":"Drug: Zoladex","description":"Patients currently treated with Zoladex"}],"outcomes":[{"outcome_type":"primary","measure":"Muscle protein synthesis rate","time_frame":"The muscle biopsy will be collected two hours after the last exercise session.","description":"The protein synthesis rate will be calculated based on the increased enrichment of deuterium, which will be ingested the week prior to the acute day, in muscle protein isolated from muscle biopsies. Deuterium enrichment is assessed by mass spectrometry."},{"outcome_type":"secondary","measure":"Muscle cell signalling","time_frame":"Muscle biopsies will be collected on the Acute day. Muscle biopsies obtained 3.5 (baseline biopsy) and 1 hours (post meal) prior to the last exercise session, and 2 hours (post exercise) after the last exercise session will be used","description":"Changes in the activity of enzymes involved in anabolic- and catabolic signalling, as well as levels of key enzymes related to glucose metabolism, heat shock proteins, and indicators of autophagy capacity, will be analyzed by western blot according to standard operating procedures."},{"outcome_type":"secondary","measure":"Plasma insulin levels","time_frame":"A fasted blood sample will be collected first thing in the morning at the Acute day. Then again at 15, 30, 45, 60, 75, 90, 105, and 120 minutes post meal and post exercise.","description":"Will be collected in EDTA vacutainers through venous catheters, centrifuged and serum will be stored at -20ºC for later analysis. When serum from all patients has been collected, insulin levels will be analyzed."},{"outcome_type":"secondary","measure":"Plasma glucose levels","time_frame":"A fasted blood sample will be collected first thing in the morning at the Acute day. Then again at 15, 30, 45, 60, 75, 90, 105, and 120 minutes post meal and post exercise.","description":"Will be collected in EDTA vacutainers through venous catheters, centrifuged and serum will be stored at -20ºC for later analysis. When serum from all patients has been collected, glucose levels will be analyzed, along with other hormones and signaling molecules."},{"outcome_type":"secondary","measure":"Ribosomal RNA","time_frame":"Muscle biopsies will be obtained at the Acute day. Muscle biopsies for ribosomal RNA analysis will be obtained 3.5 hours prior to the last exercise session (baseline) and 2 hours post the last exercise session (post exercise)","description":"The expression of ribosomal RNAs (including the large subunit; 28S and 5.8S, and the small subunit; 18S) will be assessed by qPCR, to evaluate the translational capacity of the muscle. Also, the acute change in mRNA expression levels of growth factors (e.g. MGF, IGF-1), ubiquitin-proteasome system (e.g. murf-1 and Atrogin-1), genes involved in autophagy (e.g. LC3 and p62), and other testosterone sensitive genes will be analyzed."},{"outcome_type":"other","measure":"Single muscle fiber myonuclear domain","time_frame":"Muscle biopsies will be obtained at the Acute day. For the single fiber analysis, only baseline biopsies obtained 3.5 hours prior to the last exercise session will be used.","description":"Single muscle fibers will be isolated from the biopsy specimen. Later, to evaluate if ADT influences the myonuclear domain size, structural analysis, including evaluation for the 3D spatial arrangement of nuclei in relation to myosin content using a unique analysis algorithm applied to confocal images."},{"outcome_type":"other","measure":"Single muscle fiber power analysis","time_frame":"Muscle biopsies will be obtained at the Acute day. For the single fiber analysis, only baseline biopsies obtained 3.5 hours prior to the last exercise session will be used.","description":"Single muscle fibers will be isolated from the biopsy specimen, membrane-permeabilized and a series of contractile measures will be used to analyse force and velocity (power) following standard protocols."},{"outcome_type":"other","measure":"Single muscle fiber stiffness","time_frame":"Muscle biopsies will be obtained at the Acute day. For the single fiber analysis, only baseline biopsies obtained 3.5 hours prior to the last exercise session will be used.","description":"Single muscle fibers will be isolated from the biopsy specimen, membrane-permeabilized and stiffness will be analyzed using standard protocols."},{"outcome_type":"other","measure":"The number of capillaries per fiber","time_frame":"Muscle biopsies will be obtained at the Acute day. For the immunohistochemical analysis, only baseline biopsies obtained 3.5 hours prior to the last exercise session will be used.","description":"The number of capillaries per fiber will be analyzed by immunohistochemistry according to standard procedures, and used as covariates in several analyses"},{"outcome_type":"other","measure":"Muscle fiber-type specific cross-sectional area","time_frame":"Muscle biopsies will be obtained at the Acute day. For the immunohistochemical analysis, only baseline biopsies obtained 3.5 hours prior to the last exercise session will be used.","description":"The baseline fiber-type specific cross-sectional area, the relative fiber type distribution will be analyzed by immunohistochemistry on muscle cryosections according to standard procedures, and used as covariates in several analyses"},{"outcome_type":"other","measure":"Myonuclei numbers","time_frame":"Muscle biopsies will be obtained at the Acute day. For the immunohistochemical analysis, only baseline biopsies obtained 3.5 hours prior to the last exercise session will be used.","description":"The number of myonuclei will be analyzed by immunohistochemistry according to standard procedures, and used as covariates in several analyses"},{"outcome_type":"other","measure":"Lean body mass","time_frame":"1 day","description":"Total lean body mass will be evaluated by dual x-ray absorptiometry (Lunar iDXA, GE Healthcare, Madison, USA) and will be used as a covariate in several analysis related to glucose metabolism."},{"outcome_type":"other","measure":"Fat mass","time_frame":"1 day","description":"Fat mass will be evaluated by dual x-ray absorptiometry (Lunar iDXA, GE Healthcare, Madison, USA), and will be used as a covariate in several analysis related to glucose metabolism."}]}
{"nct_id":"NCT03284112","start_date":"2018-09-18","phase":"N/A","enrollment":6000,"brief_title":"Old SCHOOL Hip-Hop: Improve Alzheimer's Disease Knowledge","official_title":"Old SCHOOL Hip-Hop: A Randomized Controlled Trial to Improve Alzheimer's Disease Knowledge","primary_completion_date":"2022-07-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-07-31","last_update":"2021-03-23","description":"The purpose of this research study is to evaluate the knowledge of parents and children with respect to dementia symptoms, risk factors, and response before and after an interactive dementia education program that uses music and dance to enhance a health education curriculum at 1-week and 3-months after the intervention.","other_id":"AAAR5473","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":9,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  4th and 5th-grade children (ages 9-11y) and their parents (age > 20 years).\r\n\r\n          -  Selected New York City public schools with similar socio-demographic composition.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Schools have already received pilot OSHH and the U.S. Department of Health and Human\r\n             Services (HHS) programming.\r\n      ","sponsor":"Columbia University","sponsor_type":"Other","conditions":"Dementia","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Old SCHOOL Hip-Hop","description":"A school-based intervention called \"Old S.C.H.O.O.L. Hip-Hop\" (OSHH) or Seniors Can Have Optimal aging and Ongoing Longevity, to educate 4th and 5th grade students (ages 9-11y) about key dementia signs and symptoms, basic pathophysiology of Alzheimer disease, and the importance of early recognition, care-seeking behavior, and preventative measures (lifelong healthy lifestyle decisions). The intervention is delivered in a classroom or school auditorium setting, using an innovative, modular, multimedia program and home-based activities, to increase parental and family dementia literacy."},{"intervention_type":"Behavioral","name":"Behavioral: My Plate","description":"The program selected for the control arm, \"My Plate,\" will address nutrition, physical activity, and obesity education. This program was selected because nutrition, physical activity, and wellness programs are now being incorporated into New York City public school curriculums as part of a legislative directive. Trained facilitators will conduct \"My Plate\" as an entry point for the USDA's My Plate nutrition program. Students will learn about My Plate across the 3-day one-hour-a-day program."}],"outcomes":[{"outcome_type":"primary","measure":"Change in Dementia Symptom and Response Knowledge Assessment Score","time_frame":"Baseline, 1 week, 3 months","description":"An instrument with multiple choice questions to assess knowledge of recognition of 6 key signs/symptoms and ability to formulate the correct action plan in response to recognizing dementia."}]}
{"nct_id":"NCT03761264","start_date":"2018-09-18","phase":"Phase 2","enrollment":55,"brief_title":"Systemic and Local Antimicrobials in the Management of Dental Abscess in Children","official_title":"Clinical, Microbiological and Quality of Life Outcomes Following Use of Systemic and Local Antimicrobials in the Management of Odontogenic Infections in Paediatric Patients","primary_completion_date":"2020-02-13","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-02-13","last_update":"2020-05-12","description":"Dental infections originating in the teeth are routinely managed systemically with a course of oral antibiotics, while severe forms are managed with intravenous antibiotics. Dental infections can also be managed by removing the offending cause of the infection followed by placement of an intra-canal medication which acts as a local antimicrobial. Intra-canal medicaments are being used in clinical practice following root canal treatment. The investigators hypothesize that the effect of intra-canal antimicrobials in the management of dental infections will be the better than oral antibiotics in terms of clinical , microbial and oral- health quality of life parameters. This will be a three-arm, parallel, comparative, randomized study with the aim of assessing the efficacy of intra-canal medication and oral antibiotics in reducing the infection and treatment of odontogenic infections, based on signs and symptoms and microbial count. The study will be performed in child participants between the age group of 3 to 11 years presenting with acute odontogenic infections. Participants will be randomized by block randomization. The treatment duration of the study will be at least 5 days or maximum 7 days depending upon the response. Participants will be assessed on Day 3 and Day 5/7. Concurrently, the oral health-related quality of life (OHRQoL) following these clinical interventions in children will be recorded and again on Day 14. Quantitative assessment of microorganisms seen in the root canals and the changes seen in the microbial flora through the treatment will help us to determine the best antimicrobial agent to be used in the management of odontogenic infections.","other_id":"RP053A-17HTM","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":3,"maximum_age":11,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients presenting with acute odontogenic infections on primary teeth with evidence\r\n             of intra-oral / extra- oral swelling and pus discharge\r\n\r\n          -  Absence of any systemic disease\r\n\r\n          -  Age group between 3-11 years\r\n\r\n          -  Malaysian citizen\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients taking antibiotics 30 days prior to their attendance to the department\r\n\r\n          -  Presence of any systemic disease\r\n\r\n          -  Patients with cellulitis\r\n\r\n          -  Patients suffering from spreading odontogenic infections which require hospitalization\r\n             or immediate IV antibiotic treatment\r\n\r\n          -  Tooth with poor prognosis for extraction\r\n\r\n          -  Extensively resorbed roots (> 2/3rd)\r\n\r\n          -  Patients allergic or resistance to amoxicillin\r\n\r\n          -  Non-Malaysian citizen\r\n      ","sponsor":"University of Malaya","sponsor_type":"Other","conditions":"Dentoalveolar Abscess","interventions":[{"intervention_type":"Drug","name":"Drug: Odontopaste","description":"Teeth with abscess will be opened from the crown to allow cleaning of the canals following which the Odontopaste will be placed in the canals and the pulp chamber. Cavity will be sealed with capsulated Glass ionomer cement."},{"intervention_type":"Drug","name":"Drug: Pulpdent","description":"Teeth with abscess will be opened from the crown to allow cleaning of the canals following which the Pulpdent paste will be placed in the canals and the pulp chamber. Cavity will be sealed with capsulated Glass ionomer cement."},{"intervention_type":"Drug","name":"Drug: Amoxicillin","description":"Teeth with abscess will be opened from the crown to allow cleaning of the canals . A sterile cotton pellet will be placed in the pulp chamber and cavity sealed with capsulated Glass ionomer cement. The patient will be prescribed oral amoxicillin at 15mg/kg body weight tds for 5 days"}],"outcomes":[{"outcome_type":"primary","measure":"Mean Change From Baseline in Wong Baker Faces Pain Rating Scale of Pain Score at Day 3, Day 5 or 7","time_frame":"Baseline, Days 3, 5 or 7","description":"Wong Baker Faces Pain Rating Scale (WBFPRS) is used to measure the amount of pain that a participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain. Change in Pain is documented as WBFPRS score at Baseline and subsequent reviews."},{"outcome_type":"primary","measure":"Mean Change From Baseline in Visual Rating Scale of Swelling Score at Days 3, 5 or 7","time_frame":"Baseline, Days 3, 5 or 7","description":"Visual Rating Scale (VRS) is used to measure the degree of swelling that the participant experiences. This scale has numerical ratings from 0 to 5. Zero indicates no swelling pain and 5 indicates worse swelling imaginable. Change in Swelling is documented as VRS score at Baseline and subsequent reviews."},{"outcome_type":"primary","measure":"Mean Change From Baseline in Regional Lymphadenitis Score at Days 3, 5 or 7","time_frame":"Baseline, Days 3, 5 or 7","description":"Examination of lymph nodes is performed and recorded as 0,1 and 2. Zero indicates no inflammation of lymph nodes; 1 is described as inflammation of regional lymph nodes, palpatory examination painless, and a score of 2 indicates inflammation of regional lymph nodes, palpatory examination painful."},{"outcome_type":"primary","measure":"Mean Change From Baseline in Temperature Score at Days 3, 5 or 7","time_frame":"Baseline, Days 3, 5 or 7","description":"Temperature is recorded as baseline and on review visits as 0,1 and 2. Zero indicates afebrile (up to 36.9 °C),1 as subfebrile (37-37.9 °C) and 2 as febrile (38 °C and more)"},{"outcome_type":"primary","measure":"Mean Change From Baseline in Trismus Score at Days 3, 5 or 7","time_frame":"Baseline, Days 3, 5 or 7","description":"Distance measurement between incisal ridge of upper and lower jaw in case a patient had the teeth and in case the teeth were missing the measurement was based on the distance between alveolar ridges of the frontal region. The measured results were evaluated according to the established scale: 0 - there is no trismus (21 mm and more),1 - slightly pronounce trismus (11- 20 mm) and score 2 as very pronounced trismus (0 -10 mm)."},{"outcome_type":"primary","measure":"Mean Change From Baseline in Percussion Score at Days 3, 5 or 7","time_frame":"Baseline, Days 3, 5 or 7","description":"Percussion is performed as light tapping on the tooth using the edge of a mouth mirror and recorded as 0 and 1. Zero is recorded as no tenderness and 1 as presence of tenderness."},{"outcome_type":"primary","measure":"Mean Change From Baseline in Fistula Score at Days 3, 5 or 7","time_frame":"Baseline, Days 3, 5 or 7","description":"Fistula is examined clinically and recorded as 0 and 1. Zero is recorded as absence of fistula and 1 as presence of fistula"},{"outcome_type":"primary","measure":"Mean Change From Baseline in Pus Discharge Score at Days 3, 5 or 7","time_frame":"Baseline, Days 3, 5 or 7","description":"Clinical examination on the abscessed tooth to document pus discharge as 0 and 1. Zero is recorded as no pus discharge and 1 as presence of pus discharge."},{"outcome_type":"primary","measure":"Mean Reduction in Bacterial Count by quantitative Polymerase Chain Reaction (q-PCR) From Baseline and at Day 5 or 7","time_frame":"Baseline, Day 5 or Day 7","description":"Quantitative assesment by q-PCR using SYBR® Green will show the count of oral anaerobes on Day 1 and Day 5 or 7 of treatment."},{"outcome_type":"primary","measure":"Mean change of ECOHIS scores from baseline and at Day 5 or Day 7","time_frame":"Baseline, Day 5 or Day 7","description":"Malay-ECOHIS comprises of child impact section and family impact section. Under child impact section consist of 4 domains which are symptom, function,psychology and self image and social interaction. Whilst, under family impact section consist of 2 domains which are parental distress and family function. Each question has six response options: 0=never; 1 = hardly ever; 2 = sometimes; 3 = often; 4 = very often; and 5 = \"I don't know\". The results will show differences in ECOHIS scores between the modes of treatments from baseline and at Day 5 or Day 7."},{"outcome_type":"secondary","measure":"Quantification of Individual Target Species","time_frame":"First 2 Months of Study","description":"A particular species of the most common bacteria seen in the root canal will be identified using meta-genomic analysis and the five most commonly seen bacteria will be chosen as target species."}]}
{"nct_id":"NCT03608410","start_date":"2018-09-18","phase":"N/A","enrollment":492,"brief_title":"Intensified Follow-up of Lung Cancer Using Weekly Questionnaires Via the Internet","official_title":"ProWide - Patient Reported Outcomes Used for Weekly Internet-based DEtection of Progressive Disease in Lung Cancer; a Randomized Controlled Trial","primary_completion_date":"2022-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-12-31","last_update":"2021-03-10","description":"This randomized controlled trial (RCT) will test if weekly supplementary internet-based self-monitoring of 12 core symptoms can increase survival in Danish lung cancer patients during follow-up or maintenance treatment. A threshold mechanism will automatically send an alert to the hospital in case of alarming or worsening symptoms and the patient will be contacted by the treating clinicians.","other_id":"ProWide","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","intervention_model_description":"The randomization will be done by the AmbuFlex-system (a generic on-line system for self-recorded patient reported outcomes) as a part of the inclusion process.\r\nA text message reminder is sent weekly for patients in the intervention group by the system.\r\nQuality of Life questionnaires will automatically be sent via a safe internet connection to participants in both groups every 2 months.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patients with lung cancer (NSCLC and SCLC), who have received 1st line induction\r\n             treatment* for lung cancer and have no sign of progressive disease at first evaluation\r\n             CT scan.\r\n\r\n          2. Patients diagnosed with stage III treated with palliative intention, and stage IV,\r\n             regardless of treatment intention.\r\n\r\n          3. Diagnosis proven by cytology or histology\r\n\r\n          4. Age  18 years\r\n\r\n          5. Performance status (PS)  2 within 15 days before enrolment\r\n\r\n          6. First evaluation CT scan performed within four weeks from enrolment\r\n\r\n          7. Patient with acess to internet, Mobile phone and E-boks (Danish digital secure mail\r\n             system)\r\n\r\n          8. Patient has given his/her written informed consent before any specific procedure from\r\n             protocol\r\n\r\n               -  Induction treatment includes:\r\n\r\n                    -  Standard doublet chemotherapy\r\n\r\n                    -  Immunotherapy\r\n\r\n                    -  Targeted therapy\r\n\r\n                    -  Palliative radiotherapy\r\n\r\n                    -  Local treatment of oligometastatic disease, including surgery and\r\n                       stereotactic radiotherapy\r\n\r\n                    -  Any combination of the above-mentioned treatment modalities Patients are\r\n                       eligible regardless of whether they at the time of inclusion continue\r\n                       maintenance treatment or not\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Progressive disease at first evaluation scan\r\n\r\n          2. Persons deprived of liberty or under guardianship or curators\r\n\r\n          3. Dementia, mental alteration or psychiatric disease that can compromise informed\r\n             consent from the patient and / or adherence to the protocol and the monitoring of the\r\n             trial\r\n\r\n          4. Pregnant or breastfeeding women\r\n\r\n          5. Patient participating in another interventional study during the surveillance period.\r\n             This is only relevant for studies that might interfere with the intervention.\r\n             Participation in protocols related only to treatment will not preclude participation\r\n             in the present study. Cases of doubt will be settled by the protocol committee.\r\n      ","sponsor":"Regional Hospital West Jutland","sponsor_type":"Other","conditions":"Lung Cancer","interventions":[{"intervention_type":"Other","name":"Other: Weekly Internet based PRO questionnaires","description":"If core symptoms worsen and exceeds a predefined threshold, a PRO-notification is sent to the hospital."}],"outcomes":[{"outcome_type":"primary","measure":"Overall survival","time_frame":"2 years"},{"outcome_type":"secondary","measure":"ECOG (Eastern Cooperative Oncology Group) Performance status at time of progression","time_frame":"2 years","description":"(0-5) 0 - Asymptomatic (Fully active, able to carry on all predisease activities without restriction)\r\n- Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. For example, light housework, office work)\r\n- Symptomatic, <50% in bed during the day (Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours)\r\n- Symptomatic, >50% in bed, but not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more of waking hours)\r\n- Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair)\r\n- Death"},{"outcome_type":"secondary","measure":"Progression free survival","time_frame":"2 years"},{"outcome_type":"secondary","measure":"Type of treatment at time of progression","time_frame":"2 years","description":"Number of patients who are candidates for 2nd line medical antineoplastic treatment"},{"outcome_type":"secondary","measure":"Quality of life (QOL) measured by EuroQol EQ-5D-5L.","time_frame":"2 years","description":"EQ-5D-5L measures individual generic health status using 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and each dimension has 5 levels depending on severity of symptoms (1 no problems, 5 extreme problems) and a VAS (visual analogue scale). The scores can then be converted into a single index number. The index value will be used for calculation of quality-adjusted life years (QALYs) for a health economic analysis of the intervention."},{"outcome_type":"secondary","measure":"Quality of life measured by EORTC QLQ C30/LC13.","time_frame":"2 years","description":"The EORTC QLQ-C30 questionnaire consists of 30 questions with five functional scores (physical, role, cognitive, emotional and social); a global health status score three symptom scale score (fatigue, pain, nausea and vomiting); and six independent one-item scores describing additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation and diarrhea) and financial burden.\r\nThe EORTC QLQ-LC13 is a supplementary module to the C30 questionnaire and generates a multiple-item scale score of dyspnea and a number of single-item scores that assesses chest pain, arm / shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia and hemoptysis.\r\nAll scales and single-item scores can be linearly transformed to a score ranged from 0 to 100. A higher score of global health and functional subscriptions indicates better functioning."},{"outcome_type":"secondary","measure":"HADS score (Hospital Anxiety And Depression Scale)","time_frame":"2 years","description":"The HADS (The hospital anxiety and depression scale) is a fourteen-item scale. Seven items relate to depression and seven to anxiety. The tool has been developed for detection of anxiety and depression in patients with physical health problems. All items are scored from 0-3 with a possible total score between 0 and 21 for anxiety and depression respectably.\r\nA cut-off point of >7 for anxiety or depression is considered significant."},{"outcome_type":"secondary","measure":"Qualitative interviews","time_frame":"2 years","description":"Qualitative interviews with members of the clinical staff and a group of patients in the intervention arm will be conducted during the study period. The purpose is to identify barriers, advantages and possible reasons for the outcomes of the study."},{"outcome_type":"secondary","measure":"Baseline questionnaires of non-participants","time_frame":"2 years","description":"All patients who met the inclusion criteria but declined to participate in the trial will be asked to fill in a questionnaire. The questionnaire will include information on socioeconomics, reasons for non-participation and the same HRQoL questionnaires that are filled in by the participants in the trial (EORTC QLQ-C30/LC13, HADS, EQ-5D-5L).\r\nThe purpose is to identify baseline differences between participants and non-participants and thereby testing the PRO system for generalizability."}]}
{"nct_id":"NCT03469011","start_date":"2018-09-18","phase":"Phase 1","enrollment":18,"brief_title":"A Study to Try to Bring Back Radioiodine Sensitivity in Patients With Advanced Thyroid Cancer.","official_title":"A Phase I Dose Escalation Trial to Determine if Imatinib Treatment Restores Sodium Iodide Symporter Function and Sensitivity to Radioiodine Treatment in Metastatic Thyroid Cancer Patients","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-12-31","last_update":"2021-06-29","description":"Thyroid cancers that have spread beyond the neck are not curable. About 30,000 people worldwide die from thyroid cancer every year. Usually, thyroid cancers get worse because the cancer cells become more and more abnormal through a process that is called dedifferentiation. Radioactive iodine is a standard treatment for this type of thyroid cancer. Patients will usually receive multiple dose of radioactive iodine over the course of their cancer journey. Thyroid cancers lose sensitivity to radioactive iodine as the cancer progresses/worsens with the process of dedifferentiation. When this occurs, the radioactive iodine treatments no longer work against the cancer and the cancer grows. Radioactive iodine enters cancer cells through transporter proteins on the outside of the cancer cell. The transporter proteins that are the most important are the sodium iodide symporters. As thyroid cancers dedifferentiate, these symporters stop working as well as they once did. The radioactive iodine can therefore not get into the cancer cells to cause cancer cell death. Laboratory research has shown that in thyroid cancer, a protein on the cell called platelet derived growth factor receptor alpha (PDGFR) is an important for tumour growth and thyroid cancer dedifferentiation. PDGFR helps cancer progression and lowers the ability of sodium iodine symporters to move radioiodine into cells where it would normal act to kill the cancer cells. PDGFR therefore makes thyroid cells resistant to radioactive iodine. Imatinib is an anti-cancer drug that blocks PDGFR function. It has been used for many years to treat other cancers such as leukemia. The investigators who wrote this study believe that, base on laboratory testing, if thyroid cancer patients are given imatinib whenafter their cancers have become resistant to radioactive iodine, the imatinib will block PDGFR. This will let the sodium iodine symporters work again and move the radioactive iodine into the cancer cells. This should shrink the tumours. Imatinib would then make the thyroid cancer cell sensitive to radioactive iodine again. This should shrink the tumours and would mean longer control of the cancer, helping people with this disease live longer.","other_id":"Imatinib-CCI-PH1-01","allocation":"N/A","intervention_model":"Sequential Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  1. Cytologically or histologically confirmed papillary thyroid cancer consisting of\r\n             papillary or follicular variants.\r\n\r\n             2. Radioiodine-refractory disease (iodine-refractory thyroid cancer) by at least one\r\n             of the following criteria:\r\n\r\n               1. an index metastatic lesion that was not radioiodine-avid on diagnostic\r\n                  radioiodine scanning performed within 28 days of enrolment;\r\n\r\n               2. a radioiodine-avid metastatic lesion that remained stable in size or progressed\r\n                  despite radioiodine treatment 3 months or more before entry into the study; or\r\n\r\n               3. 18F-fluorodeoxyglucose (FDG)-avid lesions on PET scan (if available). 3.\r\n                  Recurrent, advanced, or metastatic (Stage IV) disease that is not amenable to\r\n                  surgical resection or radiation with curative intent.\r\n\r\n                  4. Minimal or no radioactive iodine uptake demonstrated by whole body iodine\r\n                  scans.\r\n\r\n                  5. Age  18. 6. Eastern Cooperative Oncology (ECOG) performance status of  1. 7.\r\n                  Presence of measurable disease, defined as at least 1 unidimensional measurable\r\n                  lesion on a computed tomography (CT) scan as defined by RECIST 1.1.\r\n\r\n                  8. Hematology: WBC  3.0 x 109/L or granulocytes (polymorphs + bands)  1.5 x\r\n                  109/L; platelets  100 x 109/L within 4 weeks prior to enrolment.\r\n\r\n                  9. AST (SGOT) and/or ALT (SGPT) and alkaline phosphatase  5 x the upper limit of\r\n                  normal (ULN). Creatinine  1.5 x ULN.\r\n\r\n                  10. Serum amylase and lipase  1.5 x ULN 11. Serum potassium, phosphorus,\r\n                  magnesium and calcium  lower limit of normal or correctable with supplements\r\n                  prior to first dose of study drug.\r\n\r\n                  12. Be able to comply with study procedures and follow-up examinations. 13. Not\r\n                  pregnant or lactating. Male and female patients who are fertile must agree to use\r\n                  an effective means of birth control (i.e., latex condom, diaphragm, cervical cap,\r\n                  etc.) to avoid pregnancy.\r\n\r\n                  14. Sign a written informed consent.\r\n\r\n                  Exclusion Criteria:\r\n\r\n          -  1. Has received radiation therapy within 21 days of Study Day 1. 2. Has had major\r\n             surgery within 21 days of Study Day 1. 3. Has untreated brain or meningeal metastases.\r\n             Patients who have treated brain metastasis (via local radiation standards or surgical\r\n             resection or local ablative techniques) and who are either off steroids or on a stable\r\n             dose of steroids for at least one month (30 days), AND who are off anticonvulsants,\r\n             AND have radiological documented stability of lesions for at least 3 months may be\r\n             eligible. Each case should be discussed with the Principal Investigator.\r\n\r\n             4. Has a central thoracic tumor lesion as defined by location within the hilar\r\n             structures.\r\n\r\n             5. Has proteinuria CTCAE v.4.0 Grade > 1 at baseline. 6. Has a history of, or\r\n             currently exhibits clinically significant cancer related events of bleeding.\r\n\r\n             7. Currently exhibits untreated, symptomatic or persistent, uncontrolled hypertension\r\n             defined as diastolic blood pressure (BP) > 90 mm Hg or systolic BP > 140 mm Hg.\r\n\r\n             8. Has a history of myocardial infarction, stroke or Transient Ischemic Attack (TIA)\r\n             within 6 months of Study Day 1.\r\n\r\n             9. Impaired cardiac function including any of the following:\r\n\r\n               1. Has a documented left ventricular (LV) ejection fraction < 50%;\r\n\r\n               2. Long QT syndrome or family history of long QT syndrome;\r\n\r\n               3. Clinically significant resting bradycardia (<50 bpm);\r\n\r\n               4. Other clinically significant heart disease (e.g. congestive heart failure,\r\n                  uncontrolled hypertension, unstable angina, significant ventricular or atrial\r\n                  tachyarrhythmia).\r\n\r\n                  10. Treatment with strong CYP3A4 inhibitors (e.g. erythromycin, ketoconazole,\r\n                  itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir, mibefradil)\r\n                  and the treatment cannot be discontinued or switched to a different medication\r\n                  prior to starting study drug.\r\n\r\n                  11. Treatment with strong CYP3A4 inducers (e.g. dexamethasone, phenytoin,\r\n                  carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, St. John's Wort),\r\n                  and the treatment cannot be discontinued or switched to a different medication\r\n                  prior to starting study drug.\r\n\r\n                  12. Patients using medication that have been documented to prolong QT interval\r\n                  should be avoided. In the case it is not possible to avoid or switch to other\r\n                  medication, patients should be followed with caution and ECG testing should be\r\n                  requested at least every 3 months after starting study or if any dose change\r\n                  occurs or if clinical symptoms appear.\r\n\r\n                  13. Has known autoimmune disease with renal involvement (e.g. lupus). 14.\r\n                  Receiving combination anti-retroviral therapy for HIV. 15. Has clinically\r\n                  significant uncontrolled condition(s). 16. Previous or concurrent malignancies,\r\n                  excluding curatively treated in situ carcinoma of the cervix or uterus or\r\n                  non-melanoma skin cancer or in-situ carcinoma of the prostate (Gleason score  7,\r\n                  with all treatment being completed 6 months prior to enrollment, unless at least\r\n                  5 years have elapsed since last treatment and the patient is considered cured).\r\n\r\n                  17. Has active ulcerative colitis, Crohn's disease, celiac disease, short gut\r\n                  syndrome from any cause, or any other conditions that interfere with absorption.\r\n\r\n                  18. History of acute pancreatitis within one year of study entry or medical\r\n                  history of chronic pancreatitis.\r\n\r\n                  19. Has a medical condition, which in the opinion of the study investigator\r\n                  places them at an unacceptably high risk for toxicities.\r\n\r\n                  20. Pregnant or breast feeding. 21. History of non-compliance to medical regimens\r\n                  or inability to grant consent.\r\n\r\n                  22. Use of an investigational agent within 28 days prior to enrollment in the\r\n                  study or foreseen use of an investigational agent during the study.\r\n      ","sponsor":"AHS Cancer Control Alberta","sponsor_type":"Other","conditions":"Papillary Thyroid Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Imatinib Oral Tablet","description":"3+3 trial design. Cohorts of 3-6 patients with escalating imatinib doses. No intra-patient dose escalation allowed."}],"outcomes":[{"outcome_type":"primary","measure":"Restore iodine uptake","time_frame":"3 months","description":"To demonstrate that imatinib can restore iodine uptake in iodine-refractory thyroid carcinoma, as determined by whole body iodine scans."},{"outcome_type":"secondary","measure":"Decrease overall tumor burden","time_frame":"3 months","description":"To determine if treatment with imatinib and radioactive iodine ablation can decrease overall tumor burden through restored sodium iodide symporter function in iodine-refractory thyroid carcinoma. This will be assessed by thyroglobulin levels and by anatomic imaging."}]}
{"nct_id":"NCT03691649","start_date":"2018-09-14","phase":"Phase 3","enrollment":427,"brief_title":"A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 3 Study","official_title":"A Phase III, Randomized, Double-Masked, Active-Controlled, Parallel-Group, Multi-center Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 3 Study","primary_completion_date":"2019-12-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2020-10-30","last_update":"2019-12-16","description":"This is a Phase III, randomized, double-masked, active-controlled, parallel-group, multi-center study. Subjects diagnosed with glaucoma or OHT who meet eligibility criteria at Visit 1 (Screening) will washout of their current topical IOP-lowering medication(s), if any. After completing the required washout period, subjects will return for Visit 2 (Baseline, Day 1). Subjects who meet all eligibility criteria at baseline will be randomized to receive double-masked treatment for 3 months. Adult subjects will receive open-label DE-117 Ophthalmic Solution for an additional 9 months. Approximately 400 adult subjects and up to 30 pediatric subjects with glaucoma or OHT who meet all eligibility criteria will be randomized in a 1:1 ratio to receive either: - DE-117 Ophthalmic Solution once daily and Vehicle once daily, or - Timolol Maleate Ophthalmic Solution 0.5% twice daily. The study will evaluate the efficacy and safety of DE-117 Ophthalmic Solution compared with Timolol Maleate Ophthalmic Solution 0.5% in subjects with glaucoma or OHT through Month 3 and will provide additional safety data through Month 12 for subjects receiving DE-117.","other_id":"011709IN","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":1,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n         glaucoma or ocular hypertension\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Females who are pregnant, nursing, or planning a pregnancy\r\n\r\n          -  Any corneal abnormality or other condition interfering with or preventing reliable\r\n             tonometric measurements\r\n      ","sponsor":"Santen Inc.","sponsor_type":"Industry","conditions":"Glaucoma and Ocular Hypertension","interventions":[{"intervention_type":"Drug","name":"Drug: DE-117 Ophthalmic Solution","description":"Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only"},{"intervention_type":"Drug","name":"Drug: Timolol Maleate Ophthalmic Solution 0.5%","description":"Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only"}],"outcomes":[{"outcome_type":"primary","measure":"Intraocular pressure","time_frame":"Week 1, Week 6, and Month 3","description":"Change in IOP"},{"outcome_type":"secondary","measure":"Intraocular pressure","time_frame":"Week 1, Week 6, and Month 3","description":"Decrease in mean diurnal IOP reduction"}]}
{"nct_id":"NCT02966184","start_date":"2018-09-10","phase":"Phase 4","enrollment":8,"brief_title":"Comparison of Albuterol for Status Asthmaticus","official_title":"Comparison of Benzalkonium Chloride Containing Albuterol Versus Preservative Free Albuterol for the Treatment of Status Asthmaticus","primary_completion_date":"2018-10-25","study_type":"Interventional","rec_status":"Terminated","completion_date":"2018-10-25","last_update":"2021-05-20","description":"This study is designed to compare the length of continuous albuterol administration between two different albuterol formulations, BAC containing albuterol versus preservative free albuterol.","other_id":"16.0721","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":5,"maximum_age":17,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients will be included in the study if they are admitted to the 5th floor of Norton\r\n             Children's Hospital for the treatment of an acute asthma exacerbation, initiated on\r\n             continuous albuterol inhalation therapy, and are between 5 and 17 years of age.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients will be excluded from the study if they are transferred from the 5th floor to\r\n             the Pediatric Intensive Care Unit (PICU), admitted for any indication other than acute\r\n             asthma exacerbation, or removed from the inpatient asthma protocol for any given\r\n             reason.\r\n      ","sponsor":"Norton Healthcare","sponsor_type":"Other","conditions":"Status Asthmaticus","interventions":[{"intervention_type":"Drug","name":"Drug: preservative free albuterol","description":"Preservative free albuterol for nebulization"}],"outcomes":[{"outcome_type":"primary","measure":"Albuterol Administration","time_frame":"Hours until discontinuation of therapy, an average of 72 hours","description":"Length of continuous albuterol administration between patients receiving BAC containing albuterol versus preservative free albuterol during hospital admission for status asthmaticus"}]}
{"nct_id":"NCT03464981","start_date":"2018-09-10","enrollment":20,"brief_title":"Observational Hemodynamic Monitoring During LVAD Implantation Among Individuals With Advanced Heart Failure","official_title":"Observational Hemodynamic Monitoring During LVAD Implantation Among","primary_completion_date":"2020-06-01","study_type":"Observational","rec_status":"Completed","completion_date":"2020-07-01","last_update":"2020-09-25","description":"The overall objective of this pilot analysis is to characterize the hemodynamic changes that occur during implantation of a left ventricular assist device (LVAD) in patients with advanced heart failure - specifically, how right ventricular function is compromised as a result of LVAD implantation.","other_id":"17-2119","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients with advanced HF who are scheduled to undergo LVAD implantation with either the\r\n        Heartmate 2, Heartmate 3 (Abbott, Abbott Park, IL) or HVAD (Medtronic, Minneapolis, MD)\r\n        LVADs","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  individuals  18 years of age with severe heart failure (HF) and who have been\r\n             approved by the advanced HF selection committee for LVAD implantation.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with pre-existing right ventricular (RV) dysfunction/failure, defined as:\r\n\r\n               1. Imaging evidence of moderate-severe RV dysfunction on echocardiography\r\n\r\n               2. Hemodynamic evidence of RV dysfunction with:\r\n\r\n                    -  a right-atrial pressure (RAP): pulmonary capillary wedge pressure (PCWP)\r\n                       ratio of  0.67 (note: this index compares pressures on the right [RAP] and\r\n                       left [PCWP] side of the heart;\r\n\r\n                    -  an RAP/PCWP ratio  0.67 provides hemodynamic evidence of RV dysfunction.\r\n\r\n               3. Clinical evidence of preexisting RV dysfunction, as indicated by significant\r\n                  (3-4+ peripheral edema) and/or elevated jugular venous pressures on clinical\r\n                  examination.\r\n\r\n               4. Patients with end-stage renal disease requiring hemodialysis\r\n\r\n               5. Patients requiring temporary hemodynamic support prior to LVAD implantation with\r\n                  temporary LVADs, and/or veno-arterial extracorporeal membrane oxygenators\r\n                  (\"ECMO\").\r\n\r\n               6. Planned concurrent implantation of right ventricular assist device\r\n      ","sponsor":"University of Colorado, Denver","sponsor_type":"Other","conditions":"Heart Failure|Circulatory Disorders Postprocedural Complication|Cardiomyopathy, Congestive|Surgery","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Change in Cardiovascular hemodynamics (invasive and noninvasive)","time_frame":"During LVAD implant and for 12-24 hours during ICU admission","description":"Cardiovascular hemodynamics will be measured both invasively and noninvasively as standard-of-care during LVAD implantation in the Operating Room (OR), and immediately afterwards in the CT-ICU unit prior to discharge."},{"outcome_type":"primary","measure":"Change in Heart Rate (HR)","time_frame":"During LVAD implant and for 12-24 hours during ICU admission","description":"Changes in HR will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge."},{"outcome_type":"primary","measure":"Change in Blood Pressure (BP)","time_frame":"During LVAD implant and for 12-24 hours during ICU admission","description":"Changes in BP will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge."},{"outcome_type":"primary","measure":"Change in Right Atrial (RA) pressure","time_frame":"During LVAD implant and for 12-24 hours during ICU admission","description":"Changes in RA pressure will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge."},{"outcome_type":"primary","measure":"Change in pulmonary pressure","time_frame":"During LVAD implant and for 12-24 hours during ICU admission","description":"Pulmonary pressure changes will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge."},{"outcome_type":"primary","measure":"Change in Cardiac output","time_frame":"During LVAD implant and for 12-24 hours during ICU admission","description":"Cardiac output changes will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge."},{"outcome_type":"secondary","measure":"Change in Right ventricular function","time_frame":"During LVAD implant and for 12-24 hours during ICU admission","description":"Right ventricular function will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge."},{"outcome_type":"secondary","measure":"Change in Brain blood flow","time_frame":"During LVAD implant and for 12-24 hours during ICU admission","description":"Brain blood flow will be evaluated during LVAD implantation in the OR, and immediately afterwards in the CT-ICU unit prior to discharge."}]}
{"nct_id":"NCT03740659","start_date":"2018-09-04","phase":"Phase 2","enrollment":125,"brief_title":"Evaluation Of Aqueous Humor Of Levofloxacin-Dexamethasone Eye Drops And Of Its Components In Patients Undergoing Cataract Surgery","official_title":"Aqueous Humour Concentrations After Topical apPlication of combinEd Levofloxacin-dexamethasone Eye dRops and of Its Single Components: a randoMized, assEssor-blinded, Parallel-group Study in Patients Undergoing Cataract Surgery - iPERME","primary_completion_date":"2018-12-06","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-12-06","last_update":"2020-07-07","description":"The purpose of this study is to evaluate the penetration of levofloxacin and dexamethasone 21-phosphate into the aqueous humour after ocular administration in combination or as single active ingredients.","other_id":"LevoDesa_05-2017","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"Single","intervention_model_description":"A randomized, assessor-blinded, parallel-group study.","sampling_method":"","gender":"All","minimum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Written informed consent\r\n\r\n          2. Male or female patients, aged 40 years\r\n\r\n          3. Patient undergoing phacoemulsification\r\n\r\n          4. Corneal thickness between 450 m and 600 m as measured by means of pachymetry\r\n\r\n          5. Corneal integrity confirmed by means of fluorescein test\r\n\r\n          6. Adequate pupil dilation assessed at screening\r\n\r\n          7. Female patients of childbearing potential must have a negative pregnancy test\r\n\r\n          8. Ability to fully understand all study procedures\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Corneal epithelium integrity not confirmed by fluorescein test\r\n\r\n          2. History of corneal disease or dystrophy\r\n\r\n          3. History of ocular trauma with corneal damage\r\n\r\n          4. History of acute ocular inflammation (including uveitis) in the 6 months prior to\r\n             screening\r\n\r\n          5. Previous ocular surgery (including laser treatment)\r\n\r\n          6. Glaucoma\r\n\r\n          7. Treatment with an ophthalmic investigational drug in the 3 months prior to screening\r\n\r\n          8. Treatment with any topical ocular drug within 12 hours before start of cataract\r\n             surgery other than study drugs and instillation of topical anaesthetic within 10\r\n             minutes before start of surgery\r\n\r\n          9. Treatment with any topical steroid or antibiotic drug in the 7 days prior to cataract\r\n             surgery\r\n\r\n         10. Treatment with any systemic steroid or antibiotic drug in the 7 days prior to cataract\r\n             surgery\r\n\r\n         11. Known hypersensitivity to levofloxacin, other fluoroquinolones or dexamethasone\r\n\r\n         12. Pregnant or lactating women\r\n\r\n         13. Patients who have received any investigational drug during the preceding 30 days or 5\r\n             times the plasma half-life, or who have previously participated in this trial\r\n      ","sponsor":"NTC srl","sponsor_type":"Industry","conditions":"Cataract","interventions":[{"intervention_type":"Drug","name":"Drug: Levofloxacin + Dexamethasone","description":"Levofloxacin + Dexamethasone ophthalmic solution + dexamethasone 21-phosphate administered twice: 90(15) min. and 60(15) min. before limbal paracentesis."},{"intervention_type":"Drug","name":"Drug: Levofloxacin","description":"Levofloxacin ophthalmic solution (Oftaquix) administered twice: 90 (15) min. and 60 (15) min. before limbal paracentesis)."},{"intervention_type":"Drug","name":"Drug: Dexamethasone","description":"Dexamethasone ophthalmic solution (Tamesad) administered twice: 90 (15) min. and 60 (15) min. before Limbal paracentesis."}],"outcomes":[{"outcome_type":"primary","measure":"Aqueous Humour Concentration of Levofloxacin","time_frame":"90±15 min after the first administration of the study treatments","description":"Defined as the concentration of levofloxacin into the aqueous humour in all the three arms: Levofloxacin + Dexamethasone, Dexamethasone and Levofloxacin.The concentration of levofloxacin has been measured by LC tandem mass spectrometry."},{"outcome_type":"primary","measure":"Aqueous Humour Concentration of Dexamethasone 21-phosphate","time_frame":"90±15 min after the first administration of the study treatments","description":"Defined as the concentration of dexamethasone 21-phosphate into the aqueous humour in all the three arms: Levofloxacin + Dexamethasone, Dexamethasone and Levofloxacin. The concentration of dexamethasone 21-phosphate has been measured by LC tandem mass spectrometry."},{"outcome_type":"primary","measure":"Aqueous Humour Concentration of Dexamethasone","time_frame":"90±15 min after the first administration of the study treatments","description":"Defined as the concentration of dexamethasone into the aqueous humour in all the three arms: Levofloxacin + Dexamethasone, Dexamethasone and Levofloxacin.The concentration of dexamethasone has been measured by LC tandem mass spectrometry."}]}
{"nct_id":"NCT03615573","start_date":"2018-09-04","enrollment":100,"brief_title":"Survey Study: Financial Impact of Breast Cancer Treatment","official_title":"Determining the Financial Impact of Breast Cancer Treatment Over a One Year Period for Patients at a Rural Cancer Center","primary_completion_date":"2021-06-30","study_type":"Observational","rec_status":"Recruiting","completion_date":"2021-12-31","last_update":"2021-02-03","description":"A survey study to evaluate the financial impact of breast cancer as self-reported by breast cancer patients over a period of 1 year. The study will also look at the health insurance literacy and patient's utilization of support services.","other_id":"1808-42","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients seen at rural cancer center with diagnosis of breast cancer or a recurrence of\r\n        breast cancer within the past 2 years","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18 years or older\r\n\r\n          -  Diagnosed with breast cancer or a recurrence of breast cancer within the past 2 years\r\n\r\n          -  Willing to sign consent\r\n\r\n          -  Able to read and complete surveys in English\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Cancer diagnosis other than breast cancer\r\n\r\n          -  More than 2 years since diagnosis with breast cancer or recurrence\r\n      ","sponsor":"The Guthrie Clinic","sponsor_type":"Other","conditions":"Breast Cancer","interventions":[{"intervention_type":"Other","name":"Other: Quality of Life Surveys","description":"Patients with breast cancer diagnosis complete questionnaires over 20-30 minutes at baseline and at 3, 6, and 12 months after enrollment."}],"outcomes":[{"outcome_type":"primary","measure":"Change in level of self-reported financial burden","time_frame":"Baseline through 1 year","description":"Will evaluate the change in Comprehensive Score for Financial Toxicity (COST-FACIT) measurements from baseline to 1 year follow up. This survey consists of 14 questions related to finances.Responses include 5 options with lower scores representing worse outcomes. Scores at 1 year will be compared to baseline scores."},{"outcome_type":"secondary","measure":"Change in level of self-reported health insurance literacy","time_frame":"Baseline through 1 year","description":"Will evaluate the change in Health Insurance Literacy Measurements (HILM) from baseline to 1 year follow up"},{"outcome_type":"secondary","measure":"Self-reported access and utilization of institutional support services","time_frame":"Baseline through 1 year","description":"Will evaluate reported access and utilization of institutional support services and its association to financial burden in the first 12 months after enrollment."}]}
{"nct_id":"NCT03849924","start_date":"2018-09-03","phase":"N/A","enrollment":66,"brief_title":"Enhancing One's Sense of Self Using Self-Affirmation","official_title":"Promoting and Protecting Subjective Well-Being Using Self-Affirmation","primary_completion_date":"2018-09-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-09-28","last_update":"2019-02-21","description":"This study evaluates whether a brief psychological intervention, known as a self-affirmation intervention which works by allowing one to recognise their own value, can improve well-being. This study also evaluates whether more of these interventions will lead to greater increases in well-being, and also measures self-esteem and anxiety to examine their potential involvement in the self-affirmation process. Participants are randomly assigned to either a self-affirmation intervention group, a 'booster' self-affirmation group whereby they receive the intervention twice, or a control group (no intervention). Participant's well-being, self-esteem and anxiety are assessed at baseline (before the intervention), 1 week, and 2 weeks after the intervention. It is hypothesised that those who undergo self-affirmation will have more improved levels of well-being than those who do not; those who undergo the self-affirmation twice will have the most improved levels of well-being. It is also hypothesised that self-esteem and state anxiety will be involved in the self-affirmation process and potentially mediate the effects of self-affirmation on well-being.","other_id":"NHS001384","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"Quadruple","intervention_model_description":"Participants are randomly assigned to an intervention group, intervention 'booster' group (receive the intervention twice) or a control group via a web-based randomiser.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Anyone that attends the NHS college designed to improve health and well-being that is\r\n             willing to participate in the study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any cognitive/psychological deficits that would affect the individual's capacity to\r\n             consent\r\n      ","sponsor":"University of Manchester","sponsor_type":"Other","conditions":"Mental Health Wellness 1|Anxiety|Self Esteem","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Self-affirmation","description":"Self-affirmation implementation intentions in the form of a questionnaire."}],"outcomes":[{"outcome_type":"primary","measure":"Change from baseline subjective well-being at 2-weeks follow up","time_frame":"Through study completion, up to 2 weeks","description":"This questionnaire assesses the three main components of subjective well-being, using the four items advised by the UK Office for National Statistics. These subjective well-being components include evaluation (\"Overall, how satisfied are you with your life nowadays?\"), experience (\"Overall, how happy did you feel yesterday?\" and \"Overall, how anxious did you feel yesterday?\") and eudemonic (\"Overall, to what extend do you feel the things you do in your life are worthwhile?\"). Participants were asked to respond to questionnaire items on 11-point Likert-type scales from 'not at all' (0) to 'completely' (10)."},{"outcome_type":"secondary","measure":"Change from baseline self-esteem at 2-weeks follow up","time_frame":"Through study completion, up to 2 weeks","description":"Robins et al.'s (2001) scale- This scale only consists of one item, namely \"I have high self-esteem\"."},{"outcome_type":"secondary","measure":"Change from baseline self-esteem domains at 2-weeks follow up","time_frame":"Through study completion, up to 2 weeks","description":"Another self-esteem measure that was used in the study is Geller et al.'s, (1997) shape and weight-based self-esteem scale. This was used to determine the domains of which participants derive their self-esteem from. Participants were presented with a list of 8 items, from 8 domains, of which they may derive their self-esteem from. They were then asked to identify which domains are important to them and then rank these in terms of their personal importance."},{"outcome_type":"secondary","measure":"Change from baseline state anxiety at 2-weeks follow up","time_frame":"Through study completion, up to 2 weeks","description":"Marteau and Bekker's (1992) short version of the state scale of the Spielberger State-Trait Anxiety Inventory (1979) was used to measure state anxiety. It consists of six items on 4-point Likert-type scales ranging from 'not at all' (1) to 'very much' (4). The six items used in the inventory are \"I feel calm\", \"I am tense\", \"I feel upset\", \"I am relaxed\", \"I feel content\" and \"I am worried\"."}]}
{"nct_id":"NCT03402581","start_date":"2018-09-02","enrollment":100,"brief_title":"The Effect of Different Videolaryngoscopes on Intubation Success in Obese Patients","official_title":"The Effect of Different Videolaryngoscopes on Intubation Success in Obese Patients","primary_completion_date":"2018-12-01","study_type":"Observational [Patient Registry]","rec_status":"Completed","completion_date":"2018-12-01","last_update":"2020-03-02","description":"Obese patients may have difficulty in airway management.Patients who have body mass index > 35 are challenging patients for anesthesiologist. Short neck, more adipose tissue may be reasons for airway difficulty. Videolaryngoscopes are devices that ease the management of difficult airway.This study is designed to evaluate the differences and the effects of different laryngoscopes.","other_id":"18-925-16","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":65,"population":"patients undergoing elective surgery and have body mass index > 35","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  body mass index> 35\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  emergency airway\r\n      ","sponsor":"Ankara University","sponsor_type":"Other","conditions":"Difficult Airway, Videolaryngoscopes","interventions":[{"intervention_type":"Device","name":"Device: c-mac laryngoscope","description":"type of laryngoscopes"}],"outcomes":[{"outcome_type":"primary","measure":"intubation difficulty","time_frame":"1 minute","description":"the management of airway"},{"outcome_type":"secondary","measure":"airway assesment","time_frame":"1 minute","description":"evaluating the airway"}]}
{"nct_id":"NCT03907306","start_date":"2018-09-01","phase":"N/A","enrollment":100,"brief_title":"Cold Argon Plasma (CAP) Application in the Wound Treatment After Open Hemorrhoidectomy","official_title":"Cold Argon Plasma Application in the Wound Treatment After Open Hemorrhoidectomy","primary_completion_date":"2019-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2021-03-31","last_update":"2019-04-08","description":"This is single-center, prospective, randomized study","other_id":"120","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  3-4 stage hemorrhoids\r\n\r\n          -  3 hemorrhoids\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  patients underwent anal canals intervention\r\n\r\n          -  acute hemorrhoids\r\n\r\n          -  inflammatory bowel disease\r\n\r\n          -  co-morbidity diseases of anal canal and perianal area\r\n\r\n          -  concurrent conditions in the stage of decompensation\r\n      ","sponsor":"State Scientific Centre of Coloproctology, Russian Federation","sponsor_type":"Other","conditions":"Cold Argon Plasma","interventions":[{"intervention_type":"Procedure","name":"Procedure: Wound healing","description":"The measurement of a wound area is committed on the 2nd, 8th, 14th, 21nd and 30th day after operation. By means of the mathematical formulas the wound healing speed will be defined. The wound process will be researched with the help of cytological method. The wound prints will be taken on the 2nd, 8th, 14th, 21nd and 30th day after operation. Microbiological research of a wound will be held on the 2nd, 8th, 14th, 21nd and 30th day after operation (in study groups before and after the usage of CAP, in control groups once). The pain assessment will be measured by a visual analogue scale on the 2nd, 3rd,4th, 5th, 6th, 7th, 8th, 14th, 21nd and 30th day after operation. The life quality will be researched by means of Health Status Survey on the 8th and 30th day before operation."}],"outcomes":[{"outcome_type":"primary","measure":"Wound healing","time_frame":"30 days","description":"Total wound healing will be assessed with the help of cytological and macroscopic methods.In the cytological method the presence of fibroblasts, mature epithelial cells, scar tissue formation and the absence of inflammation will be the criterion of wound healing, as well as the presence of macroscopic features of wound epithelialization."},{"outcome_type":"secondary","measure":"Pain Intensity Measure","time_frame":"2, 3, 4, 5, 6, 7, 8, 14, 21, 30 days","description":"Visual analogue scale (0-10 points)"},{"outcome_type":"secondary","measure":"Life quality","time_frame":"before operation, 8 days, 30 days","description":"Short Form - 36 Health Status Survey"},{"outcome_type":"secondary","measure":"Microbiological contamination of wound area","time_frame":"2, 8, 14, 21, 30 days","description":"Microbiological contamination from the post operation wound area. The assessment of CAP effect on bacteria in planktonic and biofilm forms. Microbiological research of a wound will be held on the 2nd, 8th, 14th, 21nd and 30th day after operation (in study groups before and after the usage of CAP, in control groups once)."}]}
{"nct_id":"NCT04654819","start_date":"2018-09-01","phase":"N/A","enrollment":100,"brief_title":"Analysis of Student Confidence Levels and Application Success Rates in Simulator Based Dental Anesthesia Education","official_title":"Analysis of Student Confidence Levels and Application Success Rates in Simulator Based Dental Anesthesia Education","primary_completion_date":"2020-07-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-07-01","last_update":"2020-12-04","description":"The present study investigates confidence levels reported among intern dentists who used dental anesthesia simulators, before performing local anesthesia on patients as well as patient reports on intern dentist confidence levels to deliver anesthesia injections and compare them to those who did not receive dental anesthesia simulator education. Application success rates will also be investigated and compared. The study was carried out in the dental anesthesia simulator laboratory and in the faculty clinics of Ankara University, Faculty of Dentistry. A hundred volunteer intern dentists who completed the third year of the 5-year undergraduate education program and who had not performed local anesthesia on a patient contributed. Seventy intern dentists received training on dental anesthesia simulators, and made applications on patients, while 30 intern dentists made applications without training on the dental anesthesia simulators and served as control. With a prepared single questionnaire, intern dentists made self-assessment of preparedness and confidence, educators made assessment of application success rates and treated patients evaluated intern dentists' confidence levels.","other_id":"AnkaraU 14/16","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":25,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Intern dentists who had completed the third year of the 5-year undergraduate education\r\n             program\r\n\r\n          2. Not applied local anesthesia to a patient\r\n\r\n          3. Consent to participate\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Applied local anesthesia to a patient\r\n\r\n          2. Not consenting to participate\r\n      ","sponsor":"Ankara University","sponsor_type":"Other","conditions":"Confidence, Self","interventions":[{"intervention_type":"Device","name":"Device: Dental anesthesia simulator usage","description":"Training on dental anesthesia simulator"}],"outcomes":[{"outcome_type":"primary","measure":"Self-reported preparedeness and confidence levels of intern dentists","time_frame":"2 years","description":"Intern preparedeness and confidence levels was assesed with a questionnaire answered by the intern dentists. Questions will be answered on a 5 point scale: Strongly agree, Agree, Indecisive, Disagree, Strongly disagree."},{"outcome_type":"primary","measure":"Patients perception of intern dentist confidence levels","time_frame":"2 years","description":"Patients perception of intern dentist confidence was assesed with a prepared questionnaire answered by the patients. Questions will be answered on a 5 point scale: Strongly agree, Agree, Indecisive, Disagree, Strongly disagree."}]}
{"nct_id":"NCT03193073","start_date":"2018-09-01","phase":"N/A","enrollment":80,"brief_title":"Anemia Correction and Fibroblast Growth Factor 23 Levels in Chronic Kidney Disease , and Renal Transplant Patient","official_title":"Impact of Anemia Correction and Fibroblast Growth Factor 23 Levels in Left Ventricular Hypertrophy, and Early Endothelial Dysfunction in Chronic Kidney Disease, and Renal Transplant Patient","primary_completion_date":"2020-09-01","study_type":"Interventional","rec_status":"Suspended","completion_date":"2020-12-01","last_update":"2018-06-27","description":"The fibroblast growth factor-23-bone-kidney axis is part of newly discovered biological systems linking bone to other organ functions through a complex endocrine network that is integrated with the parathormone/vitamin D axis and which plays an equally important role in health and disease . Most of the known physiological function of fibroblast growth factor 23 to regulate mineral metabolism can be accounted for by actions of this hormone on the kidney.In a recent experimental study, fibroblast growth factor-23 was shown to cause pathological hypertrophy in rat cardiomyocytes by \"calcineurin-nuclear factor of activated T cells\" and treatment with fibroblast growth factor -blockers reduced left ventricular hypertrophy in experimental models of chronic renal failure.The current hypothesis is that, in healthy individuals, iron deficiency stimulates increased production of fibroblast growth factor23. At the same time, iron is thought to be the cofactor of enzymes taking part in the degradation of intact fibroblast growth factor-23 and thought to have a role in the excretion of degraded FGF-23 parts .Studies speculated that Angiotensin Converting Enzyme inhibitors may exert their anti-proteinuria effects at least in part by reducing serum fibroblast growth factor-23 levels although it is difficult from the results of this study to understand which comes first and brings about the other; decrease in proteinuria or fibroblast growth factor-23. Available evidence points to the deleterious effects of increased fibroblast growth factor-23 level in proteinuria, but the precise molecular mechanism still remains to be explored. An intricate and close association exists among parathormone, phosphorus, active vitamin D with FGF23, but the independent role of the latter on proteinuria is the least explored. Elaborately conducted studies that control effects of confounding factors adequately are needed to demonstrate the independent pathogenic role of FGF23.","other_id":"17200031","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","intervention_model_description":"two groups of patients (group A: CKD and group B newly transplanted patients) are assigned for detailed echocardiography , serum FGF-23, flow mediated dilatation of the forearm before anaemia correction in group A and renal transplant in group B .\r\nAlso assesment of FGF-23 in different stages of group A, assessment of FGF-23 before and after renal transplant","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        All patients:\r\n\r\n          1. Above 18 years old\r\n\r\n          2. Diagnosed as CKD, and renal transplanted patients at Assiut University Hospital in the\r\n             period 2017-2020 .\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Severely hypocalcaemic patients < 7mg/dl.\r\n\r\n          2. Severely hyperphosphatemic patients >7 mg/dl .\r\n\r\n          3. Uncontrolled hypertensive patients ( more than 3 antihypertensive drugs).\r\n\r\n          4. Uncontrolled diabetic patients HBA1C >8 .\r\n\r\n          5. Blood transfusion dependent\r\n      ","sponsor":"Omnia Mohammed Hashem","sponsor_type":"Other","conditions":"Anemia of Chronic Kidney Disease|Endothelial Dysfunction|Left Ventricular Hypertrophy|Fibroblast Growth Factor 23","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: detailed echocardiography","description":"Detailed Echocardiography including ejection fraction, interventricular septum thickness, posterior wall thickness, left ventricular end -diastolic and end- systolic diameter and left ventricular mass index will be correlated with body surface area for both groups serum FGF-23"},{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: serum fibroblast growth factor-23","description":"serum levels of FGF-23"},{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: flow mediated dilatation of forearm","description":"superficial sonar assess the diameter of brachial vessel on exposure to stress"}],"outcomes":[{"outcome_type":"primary","measure":"if change of in Hemoglobin level and correction of anemia associated with change in the left ventricular outcomes","time_frame":"measures at time of diagnosis then after 3 months","description":"measure the left ventricular mass index (gm/m2)"},{"outcome_type":"primary","measure":"the relationship between the FGF-23 and degree of left ventricular dysfunction","time_frame":"measure at time of diagnosis","description":"measure FGF-23 level in (pg/ml)"},{"outcome_type":"primary","measure":"the relationship between FGF-23 level and early endothelial dysfunction","time_frame":"at time of diagnosis in chronic kidney disease / after 6 months in renal transplant","description":"change in arterial diameter in mm"}]}
{"nct_id":"NCT03750968","start_date":"2018-09-01","phase":"Phase 2","enrollment":60,"brief_title":"Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects","official_title":"Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects","primary_completion_date":"2021-04-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-10-31","last_update":"2020-04-17","description":"This study is designed to test the hypotheses that (1) the third trimester of pregnancy is a period of maternal systemic and ocular carotenoid depletion; (2) prenatal supplementation with 6.0 milligrams of lutein and 0.5 milligrams of zeaxanthin will have significant effects on ocular and systemic biomarkers of maternal and infant carotenoid status relative to a matched, standard-of-care prenatal supplement without added lutein and zeaxanthin; and (3) newborn infants with the highest systemic and ocular carotenoid status will have more mature foveal structure. Mothers will be enrolled in the study during their first trimester, and will take the study carotenoid or control supplements for 6 to 8 months. The final study outcome measurements of mothers and infants will be completed within two weeks of the baby's birth.","other_id":"IRB # 116610","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Triple","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Pregnant multi-gravid women with uncomplicated obstetric histories\r\n\r\n          -  Women planning to deliver their baby at the University of Utah\r\n\r\n          -  Women planning either vaginal or Caesarian section delivery\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Women who have not had previous full-term pregnancy(ies)\r\n\r\n          -  Women who have regularly taken carotenoid supplements containing more than 0.5 mg of\r\n             lutein and/or zeaxanthin daily during the six months prior to screening\r\n\r\n          -  Women who have significant eye disease associated with macular pigment abnormalities\r\n             such as Stargardt disease, albinism, or macular telangiectasia type II (MacTel).\r\n\r\n          -  Women with conditions associated with high-risk pregnancy such as adolescent\r\n             pregnancy, multifetal pregnancy, current or past history of diabetes, pre-eclampsia,\r\n             previous premature delivery, drug abuse or other significant medical illness\r\n      ","sponsor":"Paul S. Bernstein","sponsor_type":"Other","conditions":"Nutrient Deficiency|Pregnancy Related","interventions":[{"intervention_type":"Drug","name":"Drug: Carotenoid Group","description":"DHA Softgel active ingredients: DHA 200 mg, d-Alpha Tocopherol 30 IU, Lutein 6mg"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Control Group","description":"DHA Softgel active ingredients: DHA 200 mg, d-Alpha Tocopherol 30 IU"}],"outcomes":[{"outcome_type":"primary","measure":"Change in maternal skin carotenoid levels from enrollment to birth of infant","time_frame":"up to 13 weeks gestation to birth","description":"measured in raman counts"},{"outcome_type":"primary","measure":"Change in maternal serum carotenoid levels from enrollment to birth of infant","time_frame":"up to 13 weeks gestation to birth","description":"measured in micrograms per milliliter"},{"outcome_type":"primary","measure":"Change in maternal macular carotenoid levels from enrollment to birth of infant","time_frame":"up to 13 weeks gestation to birth","description":"measured in units of macular pigment volume"},{"outcome_type":"secondary","measure":"Comparison of macular carotenoid levels between infants","time_frame":"Birth","description":"Comparison of carotenoid levels of infants whose mothers received prenatal supplements without carotenoids to those mothers who received prenatal supplements with carotenoids"},{"outcome_type":"secondary","measure":"Comparison of serum carotenoid levels between infants","time_frame":"Birth","description":"Comparison of carotenoid levels of infants whose mothers received prenatal supplements without carotenoids to those mothers who received prenatal supplements with carotenoids"},{"outcome_type":"secondary","measure":"Comparison of skin carotenoid levels between infants","time_frame":"Birth","description":"Comparison of carotenoid levels of infants whose mothers received prenatal supplements without carotenoids to those mothers who received prenatal supplements with carotenoids"}]}
{"nct_id":"NCT03571152","start_date":"2018-09-01","phase":"N/A","enrollment":10,"brief_title":"Efficacy of the Use of Educational Videos for Caregivers of Patients in Subacute Phase of Stroke","official_title":"Efficacy of the Use of Educational Videos for Caregivers of Patients in Subacute Phase of Stroke","primary_completion_date":"2018-12-02","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-12-10","last_update":"2020-03-24","description":"Stroke is the second cause of death and third of disability in the adult population, By 2020 it is projected like the fourth cause of disability-adjusted life year (DALY) and by 2030 it is estimated that it will lead the global burden of morbidity from chronic noncommunicable diseases. As a consequence of stroke, patients show a certain degree of dependence and spend most of their time with a caregiver, especially since the subacute phase of the stroke. 80% of patients who survive have motor problems. The proper care during the first three months will significantly improve until 95% the patient rehabilitation. Caregivers have reported the need for information about clinical, prevention and treatment of stroke, like information about specific tasks of patient care, mobilizations, exercises, etc. Therefore, it is necessary to train and educate the caregivers in physical aspects of care, recovery and secondary prevention. However, oversaturated health systems, insufficient number of specialists, social inequity, limited coverage and speed of access to health services are factors that make difficult to educate caregivers. Studies have demonstrated that the Information Technology applied to health is a promising solution to educate and empower the patient, carer and family. For instance, the use of educational videos to improve the level of practice or knowledge of patients with chronic pain and chronic obstructive pulmonary disease. This project aims to evaluate the efficacy of the use of educational videos for caregivers of patients in subacute phase of stroke through of the change of the level of practice, knowledge and satisfaction.","other_id":"SIDISI: 101781","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","intervention_model_description":"Pre-experimental study design The level of practice and knowledge of the caregiver will be evaluated according to the video(s) corresponding to the session. Patient participation is expected for the evaluation of the caregiver's level of practice. After thirty minutes of use of the video, the level of practice and knowledge of the caregiver will be evaluated again for the same video. In each session this methodology will continue until the eighth video. At the end of all the videos, the level of satisfaction of the caregivers in relation to the videos will be evaluated.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Familiar or known of patients in the subacute phase of ischemic stroke.\r\n\r\n          -  Familiar or known of stable dependent patients with diagnosis of hemiplegia.\r\n\r\n          -  Caregiver aged 18-65 years.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Caregiver with cognitive , severe auditory and/or visual problems.\r\n\r\n          -  Caregiver of patients who do not collaborate due to their cognitive, neurological or\r\n             psychiatric conditions.\r\n\r\n          -  Caregiver of patients with comorbidities that affect mobility, such as other\r\n             neurological disorders, orthopedic and/or traumatological alterations.\r\n      ","sponsor":"Universidad Peruana Cayetano Heredia","sponsor_type":"Other","conditions":"Stroke","interventions":[{"intervention_type":"Other","name":"Other: Educational videos","description":"The level of practice and knowledge of the caregiver will be evaluated according to the video(s) corresponding to the session. Patient participation is expected for the evaluation of the caregiver's level of practice. After thirty minutes of use of the video, the level of practice and knowledge of the caregiver will be evaluated again for the same video. In each session this methodology will continue until the eighth video. At the end of all the videos, the level of satisfaction of the caregivers in relation to the videos will be evaluated."}],"outcomes":[{"outcome_type":"primary","measure":"Practice level","time_frame":"Before and after 30 minutes of watching each video the participant will be evaluated. This method will be used for the 8 videos developed. Therefore, there will be a change in the practice level.","description":"We will use the \"evaluation form of the practice level\", a check list with items that the caregiver should perform for the 8 activities represented in the 8 videos, for each activity a minimum of 4 items and a maximum of 9 items will be evaluated. The number of items for each activity is summed, so the total number of items is 49. Therefore, the minimum score is 0% (the caregiver performed 0% of items) and the maximum score is 100% (the caregiver performed 100% of items). The higher percentage represents a better result. This instrument will be review for experts, so the number of items could change."},{"outcome_type":"secondary","measure":"Knowledge level","time_frame":"Before and after 30 minutes of watching each video, the participant will be evaluated. This method will be used for the 8 videos developed. Therefore, there will be a change in the knowledge level.","description":"We will use the \"evaluation form of the knowledge level\", which was designed for the study, a questionnaire with one-answer questions related to 8 activities represented in the 8 videos, for each activity a minimum of 2 questions and a maximum of 4 questions will be evaluated. The number of questions for each activity is summed, so the total number of questions is 25. Therefore, the minimum score is 0% (the caregiver answered correctly 0% of questions) and the maximum score is 100% (the caregiver answered correctly 100% of questions). The higher percentage represents a better result. This instrument will be review for experts, so the number of questions could change."},{"outcome_type":"secondary","measure":"Satisfaction level","time_frame":"After of watching all the videos, the participant will be evaluated. Minimum 1 video and maximum 3 videos will be evaluated per day. Therefore, minimum 3 days and maximum 8 days will be needed. The days will not be necessarily followed.","description":"We will use the \"evaluation form of the satisfaction level\", which was designed for the study, a questionnaire with 3 questions of Likert scale and 2 opened questions related to the 8 videos. Therefore, the results will be reported according to each question. This instrument will be review for experts, so this could change."}]}
{"nct_id":"NCT03340987","start_date":"2018-08-31","phase":"N/A","enrollment":26,"brief_title":"Clinical Evaluation of the Amount of Root Coverage Following The Use of VISTA Technique Versus Coronally Advanced Flap in Combination With Subepithelial Connective Tissue Graft for Management of Multiple Gingival Recessions","official_title":"Clinical Evaluation of the Amount of Root Coverage Following The Use of VISTA Technique Versus Coronally Advanced Flap in Combination With Subepithelial Connective Tissue Graft for Management of Multiple Gingival Recessions: A Randomized Controlled Clinical Trial","primary_completion_date":"2019-01-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-08-31","last_update":"2018-07-06","description":"Patients with multiple recession defects will be randomly oriented into to groups. The test group will recieve a relatively new technique, the VISTA technique, combined with connective tissue graft that will be harvested from the palate. The control group will recieve coronally advanced flap with connective tissue graft. subjects will be followed up for 6 months after the surgery. Any complications, that may occur, will be dealt with.","other_id":"VISTA technique RCT","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patient with two or more adjacent teeth with Miller class I or II facial gingival\r\n             recessions.\r\n\r\n          -  Good oral hygiene\r\n\r\n          -  Accepts follow-up period (cooperative patients).\r\n\r\n          -  Patient provides a signed informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with systemic disease that may affect periodontal health and healing.\r\n\r\n          -  Current and former smokers\r\n\r\n          -  Pregnant females.\r\n\r\n          -  Subjects received any surgical periodontal therapy in the area of interest for minimum\r\n             of 6 months prior to the study.\r\n\r\n          -  Subjects taking drugs known to interfere with wound healing.\r\n      ","sponsor":"Cairo University","sponsor_type":"Other","conditions":"Gingival Recession","interventions":[{"intervention_type":"Procedure","name":"Procedure: vestibular incision subperiosteal tunnel access","description":"vertical vestibular incision will be made down to the periosteum followed by creating a tunnel without reflecting the interdental papilla. Then a free gingival graft will be optained from the palate and de-epithelialized extraorally. The connective tissue graft will then be applied through the tunnel and the gingival margin will be sutured and the sutures will be fixed to the tooth surface by flowable composite. Then the vestibular incision will be sutured."},{"intervention_type":"Procedure","name":"Procedure: Coronally advanced flap","description":"Two horizontal incisions will be made mesial and distal to the recession area followed by two oblique incisions extended to the alveolar mucosa and a full-split thickness flap will be elevated. De-epithelialization will be done to receive the connective tissue graft obtained from the palate by de-epithelializing a free gingival graft. Then the flap will be advanced coronally aand sutured without tension"}],"outcomes":[{"outcome_type":"primary","measure":"Amount of root coverage","time_frame":"6 months","description":"complete root coverage after surgical correction measured in millimeters by using periodontal probe"},{"outcome_type":"secondary","measure":"Root Coverage Esthetic score a numbering score","time_frame":"6 months","description":"a system to evaluate esthetics after surgical root coverage giving a numbering score by a periodontal probe"},{"outcome_type":"secondary","measure":"Clinical Attachment level gain in millimeters","time_frame":"6 months","description":"the clinical attachment level is the measurement of the position of the soft tissue in relation to the cemento-enamel junction (CEJ) that is a fixed point that does not change throughout life. Two measurements are used to calculate the CAL: the probing depth and the distance from the gingival margin to the CEJ. measured using a periodontal probe in millimeters."},{"outcome_type":"secondary","measure":"Width of Keratinized tissue in millimeters","time_frame":"6 months","description":"It is measured from the mucogingival junction (MGJ) to the free gingival margin. The MGJ will be identified using the roll technique. Measured in millimeters using a periodontal probe"},{"outcome_type":"secondary","measure":"Probing depth in millimeters","time_frame":"6 months","description":"It is measuring the distance from the base of pocket to the gingival margin. The probe will be inserted parallel to the long axis of the tooth using light force. Measured in millimeters using a periodontal probe"},{"outcome_type":"secondary","measure":"Gingival thickness in millimeters","time_frame":"6 months","description":"It will be measured by penetrating the gingiva mid-buccally in the attached gingiva, half way between mucogingival junction and free gingival groove (Goaslind et al. 1977) with the periodontal probe after giving local anesthesia to measure the thickness of gingival tissues. Measured in millimeters using a periodontal probe"},{"outcome_type":"secondary","measure":"Post-Operative Pain a numerical rating scale","time_frame":"2 weeks","description":"Numerical Rating Scale (NRS) with numbers from 0 to 10 ('no pain' to 'worstpain imaginable')for the first 2 weeks postoperatively."},{"outcome_type":"secondary","measure":"Post-Operative Swelling verbal rating scale","time_frame":"7 days","description":"Verbal Rating Scale (VRS); absent(no swelling), slight (intraoral swelling at the operated area), moderate (moderate intraoral swelling at the operated area) and intense (intensive extraoral swelling extending beyond the operated area), assessed during the first 7 postoperative days"},{"outcome_type":"secondary","measure":"Post-Surgical Patient Satisfaction numerical rating scale","time_frame":"6 months","description":"A numerical rating scale will be used. A 3-item questionnaire is asked and the patients shall use a 7 point answer scale."}]}
{"nct_id":"NCT03585101","start_date":"2018-08-31","phase":"Phase 4","enrollment":0,"brief_title":"A Single-arm Evaluation of the Effect of HCV Treatment on Cardiovascular Disease Risk","official_title":"A Single-arm Evaluation of the Effect of Elbasvir/Grazoprevir on Cardiometabolic Parameters in Patients With Hepatitis C Infection and Underlying Metabolic Disease","primary_completion_date":"2019-06-30","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2020-04-30","last_update":"2018-08-07","description":"This study will assess the effect of treatment for hepatitis C virus (HCV) on cardiovascular disease risk. The study will enroll men and women who are infected with HCV and have underlying metabolic disease. All participants will receive a 12-week course of an HCV treatment (elbasvir/grazoprevir). Cardiovascular disease risk will be evaluated at baseline, week 4 on treatment, 12 weeks post-treatment, and 52 weeks post-treatment through noninvasive measurements of endothelial function, insulin resistance, liver fibrosis and steatosis, and circulating blood biomarkers.","other_id":"18-000650","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Men and women  18 years of age.\r\n\r\n          -  Presence of HCV infection for at least 12 weeks\r\n\r\n          -  Serum or plasma HCV RNA > lower limit of quantification or detection at any time\r\n             before or at the time of screening, and the absence of intervening HCV treatment\r\n\r\n          -  Absence of HIV infection\r\n\r\n          -  HCV treatment-nave OR HCV treatment-experienced with PEG-IFN/RBV only (no prior HCV\r\n             DAA exposure)\r\n\r\n          -  Genotype 1 or 4 HCV infection. If HCV genotype 1a infection is present, absence of\r\n             genotype 1a NS5A resistance associated substitutions (RASs) at amino acid positions\r\n             28, 30, 31, and 93 must be documented at screening\r\n\r\n          -  Evidence of metabolic disease defined as:\r\n\r\n               1. Insulin resistance or impaired glucose tolerance by one of the following:\r\n\r\n                    -  HOMA-IR 2.5 at screening\r\n\r\n                    -  Hemoglobin A1c 5.7-6.4% at screening\r\n\r\n                    -  Diabetes mellitus with hemoglobin A1c <7% at screening and never on more\r\n                       than one oral hypoglycemic agent, as well as never requiring insulin\r\n\r\n                  OR\r\n\r\n               2. Metabolic Syndrome, defined as at least 3 of the following:\r\n\r\n                    -  Waist circumference 102 cm for men and  88 cm for women\r\n\r\n                    -  Serum triglyceride level 150 mg/dL or on a triglyceride lowering agent\r\n\r\n                    -  Serum high-density lipoprotein (HDL) cholesterol <40 mg/dL in men and <50\r\n                       mg/dL in women or drug treatment for low HDL cholesterol\r\n\r\n                    -  Blood pressure 130/85 mmHg or drug treatment for elevated blood pressure\r\n\r\n                    -  Fasting blood glucose 100 mg/dL\r\n\r\n          -  Ability and willingness of subject to provide written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of decompensated liver disease (Child Pugh Class B or C)\r\n\r\n          -  Albumin below 3 g/dL\r\n\r\n          -  Platelet count below 75,000\r\n\r\n          -  HBsAg positivity.\r\n\r\n          -  Pregnancy or breastfeeding\r\n\r\n          -  Inability to conform to the following drug interruptions for PAT testing, whether due\r\n             to safety (determined by the investigator) or willingness: No caffeine or recreational\r\n             or prescription stimulant use for 24 hours prior; no nicotine for 4 hours prior; no\r\n             vigorous exercise for 12 hours prior; stopping of beta blockers, short-acting calcium\r\n             channel blockers (CCBs), nitrates, angiotensin-converting enzyme inhibitors (ACE-Is),\r\n             angiotensin-receptor blockers (ARBs), and renin-inhibitors for 24 hours prior; and\r\n             stopping of long acting CCBs 48 hours prior to testing.\r\n\r\n          -  Use of anticoagulant or antiplatelet agents (other than aspirin  325 mg orally daily)\r\n             within 1 week prior to study entry or anticipated need for these agents for >7 days\r\n             during the study follow-up period.\r\n\r\n          -  Use of contraindicated concomitant medications, including OATP1B1/3 inhibitors and\r\n             strong CYP3A inducers\r\n\r\n          -  Serious illness including acute liver-related disease and malignancy requiring\r\n             systemic treatment or hospitalization within 12 weeks prior to study entry.\r\n\r\n          -  History of major organ transplantation with an existing functional graft and on\r\n             immunosuppressive therapy.\r\n\r\n          -  History of known vascular disorder or autoimmune processes including Crohn's disease,\r\n             ulcerative colitis, severe psoriasis, rheumatoid arthritis, and cryoglobulinemia that\r\n             may affect vascular studies.\r\n\r\n          -  Decompensated congestive heart failure or acute cardiovascular event (such as stroke,\r\n             myocardial infarction, arrhythmia, acute peripheral arterial insufficiency) within 6\r\n             months prior to study entry\r\n\r\n          -  Use of immune-based therapies or systemic corticosteroids which may affect vascular\r\n             studies or inflammatory/endothelial biomarkers within 12 weeks prior to study entry\r\n\r\n          -  Advanced renal insufficiency as defined by glomerular filtration rate (GFR) < 30\r\n             mL/min/1.73 m2 or treatment by dialysis\r\n\r\n          -  Anticipated inability to comply with research study visits as determined by the\r\n             investigator\r\n\r\n          -  Poor venous access not allowing screening laboratory collection\r\n\r\n          -  Having any condition that the investigator considers a contraindication to study\r\n             participation\r\n      ","sponsor":"University of California, Los Angeles","sponsor_type":"Other","conditions":"Hepatitis C","interventions":[{"intervention_type":"Drug","name":"Drug: Elbasvir/grazoprevir","description":"Daily fixed-dose combination (FDC) elbasvir (EBR) (50 mg)/grazoprevir (GZR) (100 mg) for 12 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Change in reactive hyperemia index (RHI) by peripheral arterial tonometry (PAT)","time_frame":"Baseline to 12 weeks after end of EBR/GZR treatment."},{"outcome_type":"secondary","measure":"Change in insulin resistance by HOMA-IR","time_frame":"Baseline to 12 weeks after end of treatment"},{"outcome_type":"secondary","measure":"Change in reactive hyperemia index (RHI) by PAT","time_frame":"Baseline to week 4 on treatment"},{"outcome_type":"secondary","measure":"Change in reactive hyperemia index (RHI) by PAT","time_frame":"Baseline to 52 weeks after end of treatment"},{"outcome_type":"secondary","measure":"Change in insulin resistance by HOMA-IR","time_frame":"Baseline to week 4 on treatment"},{"outcome_type":"secondary","measure":"Change in insulin resistance by HOMA-IR","time_frame":"Baseline to 52 weeks after end of treatment"},{"outcome_type":"secondary","measure":"Change in hemoglobin A1c","time_frame":"Baseline to week 4, baseline to 12 weeks after end of treatment, and baseline to 52 weeks after end of treatment"},{"outcome_type":"secondary","measure":"Change in total and LDL cholesterol levels","time_frame":"Baseline to week 4, baseline to 12 weeks after end of treatment, and baseline to 52 weeks after end of treatment"},{"outcome_type":"secondary","measure":"Change in levels of each soluble biomarker (sCD163, sCD14, sICAM-1, PAI-1, sE-selectin, oxidized LDL, Lp-PLA2, and lipoprotein particle quantification)","time_frame":"Baseline to week 4, baseline to 12 weeks after end of treatment, and baseline to 52 weeks after end of treatment"},{"outcome_type":"secondary","measure":"Cross-sectional levels of each soluble biomarker (sCD163, sCD14, sICAM-1, PAI-1, sE-selectin, oxidized LDL, Lp-PLA2, and lipoprotein particle quantification) at each time point for correlation with RHI","time_frame":"Baseline, week 4, post-treatment weeks 12 and 52"},{"outcome_type":"secondary","measure":"Cross-sectional fibrosis score in kPa by transient elastography (TE) for correlation with RHI and soluble biomarkers","time_frame":"Baseline and 12 and 52 weeks after end of treatment"},{"outcome_type":"secondary","measure":"Cross-sectional steatosis score in dB/m by CAP for correlation with RHI and soluble biomarkers at the same time points","time_frame":"Baseline and 12 and 52 weeks after end of treatment"},{"outcome_type":"secondary","measure":"Change in fibrosis score by transient elastography","time_frame":"Baseline to 52 weeks after end of treatment"},{"outcome_type":"secondary","measure":"Change in hepatic steatosis score by CAP","time_frame":"Baseline to 52 weeks after end of treatment"}]}
{"nct_id":"NCT03424343","start_date":"2018-08-28","enrollment":126,"brief_title":"Longitudinal Identity Study of Childhood Cancer Survivors","official_title":"The Long-term Impact of Pediatric Cancer on Adolescents, Emerging Adults, and Their Family: Identity, Psychosocial Functioning, and Development","primary_completion_date":"2024-03-31","study_type":"Observational","rec_status":"Active, not recruiting","completion_date":"2024-03-31","last_update":"2021-01-27","description":"The study investigators plan to conduct a longitudinal questionnaire study in adolescents and emerging adults (14-25 years of age at the start of the study) who survived childhood cancer to chart their identity development and broader social functioning. Additionally, the functioning of these survivors will be related to the functioning of their parents and siblings. The investigators shall focus especially on the current experience and impact of the earlier cancer experience. They will investigate to what extent the experience of a life-threatening disease has an effect on the daily life of survivors and over time and how the survivors develop through the course of adolescence and emerging adulthood on the psychosocial level. The formation of an adult identity is a very challenging task during adolescence and the way to adulthood and the fact that these youth had cancer during their childhood may especially complicate this process of identity formation. Furthermore, both parental and sibling functioning will be taken into account, which will allow us to examine inter-generational mechanisms (thus parental functioning that possibly impacts youth functioning and vice versa) and sibling functioning in these families. To investigate the latter, at each timepoint of the longitudinal study a sibling between 14 and 25 years of age at the start of the study will be included (if there is more than one sibling in a family, ideally the sibling who is closest in age will be the one who participates in the study). Moreover, a community sample that is matched on age and sex with the survivor of pediatric cancer will be assessed. This will allow the investigators to make well-founded comparisons regarding identity development and broader psychosocial functioning.","other_id":"S60535","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":14,"maximum_age":25,"population":"Survivors of childhood cancer, treated at the department of pediatric oncology at UZ\r\n        Leuven.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Survivors of childhood leukemia/lymphoma, solid tumors, and brain tumors, of whom the\r\n             treatment has ended.\r\n\r\n          -  14-25 years at the start of the study\r\n\r\n          -  Treated at the department of pediatric oncology at University Hospital Leuven,\r\n             Belgium.\r\n\r\n          -  Sufficient knowledge of Dutch\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Mental retardation which hinders completion of the questionnaire bundle\r\n\r\n          -  Younger than 14 year and older than 25 year\r\n\r\n          -  Physically incapable to complete the questionnaire bundle\r\n\r\n          -  Insufficient knowledge of Dutch\r\n\r\n          -  Contact information is not available\r\n      ","sponsor":"KU Leuven","sponsor_type":"Other","conditions":"Pediatric Cancer","interventions":[{"intervention_type":"Other","name":"Other: Questionnaire bundle","description":"Questionnaires on identity formation and psychosocial functioning, assessed and reported at baseline, one year later, two years later, and five years later."},{"intervention_type":"Other","name":"Other: Obtaining information from survivors' medical file","description":"After obtaining informed consent, we will access the medical file of participants to obtain information on the diagnosis, time of diagnosis, treatment duration, type of treatment, and relapse (when applicable)."}],"outcomes":[{"outcome_type":"primary","measure":"Change in Dimensions of Identity Development","time_frame":"Assessed and reported at baseline, one year later, two years later, and five years later","description":"Dimensions of Identity Development Scale (DIDS); dimensions: commitment making (range: 5 - 25), Identification with Commitment (range: 5 - 25), Exploration in Breadth (rang: 5 - 25), Exploration in Depth (range: 5 - 25), Ruminative Exploration (range: 5 - 25); for each dimension, a higher score indicates more identification with the dimension"},{"outcome_type":"primary","measure":"Change in Identity from an Eriksonian Perspective","time_frame":"Assessed and reported at baseline, one year later, two years later, and five years later","description":"Erikson Psychosocial Stage Inventory (EPSI); subscales: Synthesis (range: 5 - 30), Confusion (range: 5 - 30); for each scale, higher scores indicate more identification with the scale"},{"outcome_type":"primary","measure":"Change in Illness Centrality","time_frame":"Assessed and reported at baseline, one year later, two years later, and five years later","description":"Illness Centrality; total scale range: 0 - 4; A higher score indicates more identification with the scale"},{"outcome_type":"primary","measure":"Change in Self-Identity after Cancer","time_frame":"Assessed and reported at baseline, one year later, two years later, and five years later","description":"Self-Identity after Cancer; dimensions: victim of cancer (range: 1 - 5), cancer patient (range: 1 - 5), person who had cancer (range: 1 - 5), survivor (range: 1 - 5); for each dimension, a higher score indicates more identification with the dimension"},{"outcome_type":"secondary","measure":"Change in Post-Traumatic Stress Symptoms (measured in survivors)","time_frame":"Assessed and reported at baseline, one year later, two years later, and five years later","description":"Children's Revised Impact of Event Scale (CRIES-13); total scale range: 0 - 65; Higher scores indicate more sensitivity for PTSD; A score higher than 30 possibly indicates the presence of PTSD; subscales: Intrusion (range: 0 - 20), Avoidance (range: 0 - 20), Arousal (range: 0 - 25); Higher scores indicate more identification with the scale"},{"outcome_type":"secondary","measure":"Change in Illness-related Benefit Finding (measured in survivors)","time_frame":"Assessed and reported at baseline, one year later, two years later, and five years later","description":"Benefit scale from the Benefit and Burden Scale (BBSC); total scale range: 10 - 50; A higher score indicates more identification with the scale"},{"outcome_type":"secondary","measure":"Change in Depressive Symptoms (measured in survivors, siblings, and parents)","time_frame":"Assessed and reported at baseline, one year later, two years later, and five years later","description":"Center for Epidemiologic Studies Depression (CES-D-12); total scale range: 0 - 36; a higher score indicates the presence of more depressive symptoms"},{"outcome_type":"secondary","measure":"Change in Cancer-related Worries (measured in survivors and parents)","time_frame":"Assessed and reported at baseline, one year later, two years later, and five years later","description":"Cancer Related Worries Scale; total scale range: 4 - 20; A higher score indicates the presence of more cancer-related worries"},{"outcome_type":"secondary","measure":"Change in Global Life Satisfaction (measured in survivors, siblings and parents)","time_frame":"Assessed and reported at baseline, one year later, two years later, and five years later","description":"Satisfaction with Life Scale (SWLS); total scale range: 5 - 35; A higher score indicates more satisfaction with life"},{"outcome_type":"secondary","measure":"Change in Bodily Functioning (measured in survivors)","time_frame":"Assessed and reported at baseline, one year later, two years later, and five years later","description":"Short Form 36, physical subscale (SF-36); total scale range: 10 - 30: A higher score indicates worse bodily functioning"},{"outcome_type":"secondary","measure":"Change in Self-Esteem (measured in survivors, siblings, and parents)","time_frame":"Assessed and reported at baseline, one year later, two years later, and five years later","description":"Rosenberg Self-Esteem Scale (RSES); total scale range: 10 - 40: A higher score indicates higher self-esteem"},{"outcome_type":"secondary","measure":"Change in Resilience (measured in survivors and parents)","time_frame":"Assessed and reported at baseline, one year later, two years later, and five years later","description":"Brief Resilience Scale (BRS); total scale range: 6 - 30; A higher score corresponds to being more resilient"},{"outcome_type":"secondary","measure":"Change in Personality (measured in survivors and siblings)","time_frame":"Assessed and reported at baseline, one year later, two years later, and five years later","description":"Big Five Inventory 10 (BFI-10); subscales: Extraversion (range: 2 - 10), Agreeableness (range: 2 - 10), Conscientiousness (range: 2 - 10), Neuroticism (range: 2 - 10), Openness (range: 2 - 10); for each scale, a higher score indicates more identification with the scale"},{"outcome_type":"secondary","measure":"Change in Self-Harm (measured in survivors)","time_frame":"Assessed and reported at baseline, one year later, two years later, and five years later","description":"Based on Goossens et al., 2013: Health risk behaviors in adolescents and emerging adults with congenital heart disease: psychometric properties of the Health Behavior Scale-Congenital Heart Disease"},{"outcome_type":"secondary","measure":"Change in Perception of Control (measured in survivors, siblings, and parents)","time_frame":"Assessed and reported at baseline, one year later, two years later, and five years later","description":"Multidimensional Health Locus of Control Scale (MHLCS): subscales: Internal Health Locus of Control (range 6 - 36), Powerful Others Health Locus of Control (range 6 - 36), Chance Health Locus of Control (range: 6 - 36); for each scale, a higher score indicates more identification with the scale"},{"outcome_type":"secondary","measure":"Change in Social Support (measured in survivors and siblings)","time_frame":"Assessed and reported at baseline, one year later, two years later, and five years later","description":"Multidimensional Scale of Perceived Social Support (MSPSS); subscales: support from special someone (range: 4 - 28), support from family (range: 4 - 28), support from friends (range: 4 - 28); for each subscale, a higher score indicates more support"},{"outcome_type":"secondary","measure":"Change in Contact with Peer Survivors (measured in survivors)","time_frame":"Assessed and reported at baseline, one year later, two years later, and five years later","description":"Self-constructed questionnaire"},{"outcome_type":"secondary","measure":"Change in Parental Behavioral Control (measured in survivors, parents, and siblings)","time_frame":"Assessed and reported at baseline, one year later, two years later, and five years later","description":"Based on the 8-item Parental Expectations for Behavior Scale and the 8-item Parental Monitoring of Behavior Scale uit de 'Parental Regulation Scale - Youth Self-Report' (PRS -YSR; Barber, 2002); Behavioral Control; total scale range: 7 - 35; A higher score indicates more parental behavioral control"},{"outcome_type":"secondary","measure":"Change in Parental Responsiveness (measured in survivors, parents, and siblings)","time_frame":"Assessed and reported at baseline, one year later, two years later, and five years later","description":"Child Report of Parent Behavior Inventory (CRPBI; Schaefer, 1965; Schludermann & Schludermann, 1988); Responsiveness; total scale range: 7 - 35; A higher score indicates more parental responsiveness"},{"outcome_type":"secondary","measure":"Change in Parental Overprotection (measured in survivors, parents, and siblings)","time_frame":"Assessed and reported at baseline, one year later, two years later, and five years later","description":"based on Dutch Multidimensional Overprotective Parenting Scale, Kins & Soenens, 2013; Overprotection / anxious parenting; Overprotection; total scale range: 8 - 40; A higher score indicates more parental overprotection"},{"outcome_type":"secondary","measure":"Change in Parental Psychological Control (measured in survivors, parents, and siblings)","time_frame":"Assessed and reported at baseline, one year later, two years later, and five years later","description":"8-item Psychological Control Scale-Youth Self-Report ( Barber, 1996); Psychological Control; total scale range: 8 - 40; A higher score indicates more parental psychological control"},{"outcome_type":"secondary","measure":"Change in Illness Intrusiveness (measured in parents)","time_frame":"Assessed and reported at baseline, one year later, two years later, and five years later","description":"Illness Intrusiveness Questionnaire Parent Report (IIQ-Parent Report); total scale range: 13 - 91; A higher score indicates more illness intrusiveness"},{"outcome_type":"secondary","measure":"Change in Parental competence (measured in parents)","time_frame":"Assessed and reported at baseline, one year later, two years later, and five years later","description":"Parenting Stress Index - Sense of Competence Scale; total scale range: 13 - 78; A higher score indicates a lower sense of parental competence"},{"outcome_type":"secondary","measure":"Change in Role Restriction (measured in parents)","time_frame":"Assessed and reported at baseline, one year later, two years later, and five years later","description":"Parental Burden Questionnaire, subscale role restriction; total scale range: 6 - 24; A higher score indicates a greater sense of role restriction"},{"outcome_type":"secondary","measure":"Change in Relationship Quality (measured in parents)","time_frame":"Assessed and reported at baseline, one year later, two years later, and five years later","description":"Family Functioning Questionnaire, subscale parental relationship quality; total scale range: 5 - 20; A higher score indicates a greater sense of partner relationship quality"},{"outcome_type":"secondary","measure":"Change in Benefit Finding (measured in parents)","time_frame":"Assessed and reported at baseline, one year later, two years later, and five years later","description":"Benefit Finding Scale; total scale range: 15 - 105; A higher score indicates more benefit finding"}]}
{"nct_id":"NCT03481309","start_date":"2018-08-24","phase":"N/A","enrollment":19,"brief_title":"Modulation of Motor Cortex Excitability by TMS and tDCS (MAGS1)","official_title":"Modulation of Motor Cortex Excitability by Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation","primary_completion_date":"2019-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-02-01","last_update":"2021-03-04","description":"Investigating modulation of motor cortex excitability by transcranial magnetic stimulation and transcranial direct current stimulation.","other_id":"17-0149","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Basic Science","masking_description":"Quadruple","intervention_model_description":"Each participant will be assigned to 2 active and sham conditions on a different day.","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":35,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male\r\n\r\n          -  Between the ages of 18 and 35\r\n\r\n          -  Right-handed\r\n\r\n          -  Capacity to understand all relevant risks and potential benefits of the study\r\n             (informed consent)\r\n\r\n          -  Willing to comply with all study procedures and be available for the duration of the\r\n             study\r\n\r\n          -  Speak and understand English\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior concussion\r\n\r\n          -  Diagnosis of eating disorder (current or within the past 6 months)\r\n\r\n          -  Diagnosis of obsessive compulsive disorder (lifetime)\r\n\r\n          -  Attention-deficit/hyperactivity disorder (currently under treatment)\r\n\r\n          -  Neurological disorders and conditions, including, but not limited to:\r\n\r\n               -  History of epilepsy\r\n\r\n               -  Seizures (except childhood febrile seizures and electroconvulsive therapy-induced\r\n                  seizures)\r\n\r\n               -  Dementia\r\n\r\n               -  History of stroke\r\n\r\n               -  Parkinson's disease\r\n\r\n               -  Multiple sclerosis\r\n\r\n               -  Cerebral aneurysm\r\n\r\n               -  Brain tumors\r\n\r\n          -  Medical or neurological illness or treatment for a medical disorder that could\r\n             interfere with study participation (e.g., unstable cardiac disease, HIV/AIDS,\r\n             malignancy, liver or renal impairment)\r\n\r\n          -  Prior brain surgery\r\n\r\n          -  Any brain devices/implants, including cochlear implants and aneurysm clips\r\n\r\n          -  Traumatic brain injury\r\n\r\n          -  Anything that, in the opinion of the investigator, would place the participant at\r\n             increased risk or preclude the participant's full compliance with or completion of the\r\n             study\r\n      ","sponsor":"University of North Carolina, Chapel Hill","sponsor_type":"Other","conditions":"Motor Activity|Motor Neuroplasticity","interventions":[{"intervention_type":"Device","name":"Device: anodal tDCS","description":"The participant will receive anodal tDCS with 2 mA for 10 minutes on the left motor cortex."},{"intervention_type":"Device","name":"Device: cathodal tDCS","description":"The participant will receive cathodal tDCS with -2 mA for 10 minutes on the left motor cortex."},{"intervention_type":"Device","name":"Device: sham tDCS","description":"The participant will receive sham tDCS with 2 mA for 40 seconds on the left motor cortex which mimics the skin sensations as active tDCS interventions."}],"outcomes":[{"outcome_type":"primary","measure":"Changes in Motor-evoked Potentials Ratios","time_frame":"right before and after 2mA tDCS stimulation for 10 minutes at each session","description":"The investigators will record motor-evoked potentials and calculate changes in between before and after 2mA tDCS stimulation for 10 minutes."},{"outcome_type":"primary","measure":"Changes in TMS-evoked Potentials Ratios","time_frame":"right before and after 2mA tDCS stimulation for 10 minutes at each session","description":"The investigators will record TMS-evoked potentials using EEG and calculate changes in between before and after 2mA tDCS stimulation for 10 minutes."},{"outcome_type":"secondary","measure":"Changes in Resting-state EEG Dynamics Ratios","time_frame":"4 minutes recordings before and after each 2mA tDCS stimulation for 10 minutes at each session","description":"The investigators will record participants' resting state for 4 minutes using EEG (2 minutes for eyes-closed and 2 minutes for eyes-open)"}]}
{"nct_id":"NCT03516084","start_date":"2018-08-20","phase":"Phase 3","enrollment":185,"brief_title":"A Study of Niraparib as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Patients With Extensive Stage Small Cell Lung Cancer","official_title":"A Randomized, Double-blind, Placebo-controlled, Multi-center Phase 3 Study of ZL-2306 (Niraparib) as Maintenance Therapy Following First-line Platinum-based Chemotherapy in Patients With Extensive-stage Disease Small Cell Lung Cancer (ED-SCLC) to Evaluate the Efficacy and Safety","primary_completion_date":"2020-02-21","study_type":"Interventional","rec_status":"Terminated","completion_date":"2020-03-20","last_update":"2020-12-21","description":"Niraparib is a PARP inhibitor. The study is a 2:1 randomized, double-blind, placebo-controlled, multi-center,phase 3 study of ZL-2306 (niraparib) as maintenance therapy following first-line platinum-based chemotherapy in patients with extensive-stage disease small cell lung cancer (ED-SCLC) to evaluate the efficacy and safety.","other_id":"ZL-2306-005","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Aged 18-75 years\r\n\r\n        Histologically or cytologically confirmed extensive-stage disease small cell lung cancer\r\n        (ED SCLC)\r\n\r\n        Ongoing clinical benefit (partial response [PR], or complete response [CR] per RECIST\r\n        version 1.1) following completion of 4 cycles of first-line platinum-based therapy\r\n        (cisplatin or carboplatin, plus etoposide)\r\n\r\n        Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\r\n\r\n        Subjects must have adequate bone marrow, renal and hepatic function\r\n\r\n        Exclusion Criteria:\r\n\r\n        Subjects with Central Nervous System (CNS) metastases\r\n\r\n        Subjects receiving consolidative chest radiation after last dose of first-line\r\n        chemotherapy.\r\n\r\n        Subjects with pleural effusions that cannot be controlled with appropriate interventions.\r\n\r\n        All side effects attributed to prior anti-cancer therapy must have resolved to Grade 1 or\r\n        baseline\r\n      ","sponsor":"Zai Lab (Shanghai) Co., Ltd.","sponsor_type":"Industry","conditions":"Extensive-stage Small Cell Lung Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: ZL-2306(nirapairb)","description":"The initial dose is 300mg QD or 200mg QD based on baseline weight and platelet count."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"The initial dose is 300mg QD or 200mg QD based on baseline weight and platelet count."}],"outcomes":[{"outcome_type":"primary","measure":"BICR-assessed progression-free survival (PFS)","time_frame":"Approximately 14 months since the first subject enrolled","description":"The time assessed by the Blinded Independent Central Review (BICR) from randomization to progressive disease or death due to various causes, whichever occurs; progressive disease will be assessed in accordance with RECIST 1.1 criteria."},{"outcome_type":"primary","measure":"Overall survival (OS)","time_frame":"Approximately 48 months since first subject enrolled","description":"The time from randomization to death due to any cause."},{"outcome_type":"secondary","measure":"Investigator-assessed PFS","time_frame":"Approximately 14 months since the first subject enrolled","description":"the investigator-assessed time from randomization to progressive disease or death due to various causes, whichever occurs; progressive disease will be assessed in accordance with RECIST 1.1 criteria."},{"outcome_type":"other","measure":"Change in patient reported outcomes (PROs)--physical functioning domain","time_frame":"Approximately 48 months since first subject enrolled","description":"Evaluations of the quality of life of patients with small cell lung cancer include summary and analysis of absolute values and changes from baseline of various fields and single items in the patient-completed EORTC questionnaire QLQ-C30 (Version 3.0) and QLQ-LC13 Chinese version to evaluate the quality of life of lung cancer patients in the treatment group and the control group."}]}
{"nct_id":"NCT03459092","start_date":"2018-08-16","phase":"Phase 3","enrollment":140,"brief_title":"Botox Instead of Strabismus Surgery (BISS)","official_title":"A Pragmatic, Randomized, Non-inferiority Trial Comparing the Effectiveness of Botulinum Toxin-based Treatment With Conventional Strabismus Surgery in Acquired Esotropia.","primary_completion_date":"2023-08-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-08-31","last_update":"2021-08-31","description":"The purpose of the study is to evaluate if strabismus can be successfully treated requiring less surgical interventions with a Botox-based treatment regimen compared to a purely surgery based treatment regimen. Experimental arm: Botulinum toxin injection in the horizontal extraocular muscles. Control (active comparator) arm: Strabismus surgery on the horizontal extraocular muscles. No investigational product is used. In Switzerland the standard procedure for treating large angle esotropia is surgery, which is performed on the horizontal eye muscles that may be either recessed or shortened leading to reduced or increased muscle function respectively. As an alternative to strabismus surgery, botulinum toxin (Botox) can be applied in extraocular muscles. Botox prevents the release of acetylcholine in the synaptic cleft and thereby blocks the neuromuscular transmission thus inducing a palsy. Current evidence on the use of Botox in strabismus is incoherent, is poorly supported by basic research findings and leaves dedicated clinicians in the dark. The objective is to shed light into this field of clinical research, which may help to guide future pediatric ophthalmologists in their management of strabismic patients. In a best case scenario, the results from this trial will prevent strabismus operation for many children with acquired large angle esotropia.","other_id":"33IC30 173533","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":1,"maximum_age":17,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Informed consent of trial participant and/or legal representative documented per\r\n             signature\r\n\r\n          2. Age > 1 year and <17 years\r\n\r\n          3. Esotropia > 10Prisms\r\n\r\n          4. Indication for an intervention (either Botox or surgery) has been made.\r\n\r\n          5. Any of the following:\r\n\r\n               -  Presence of a secondary strabismus from binocular disruption the cause of the\r\n                  binocular disruption is no longer present\r\n\r\n               -  Decompensated microstrabismus\r\n\r\n               -  Decompensated phoria\r\n\r\n               -  Acute acquired esotropia\r\n\r\n          6. Positive test of binocular function at any time point in the past, including any of\r\n             the following\r\n\r\n               -  Titmus test\r\n\r\n               -  Bagolini striated glasses test\r\n\r\n               -  Lang-stereo-test with correct naming of at least one panel\r\n\r\n               -  Good ocular alignment after 6 months of age on at least 2 photographs\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Known hypersensitivity to botulinum toxin\r\n\r\n          2. Known neuromuscular disorder\r\n\r\n          3. Known present neurological disorder affecting the central nervous system Including\r\n             paresis on cranial nerves number 3, 4 and 6\r\n\r\n          4. Any of the following:\r\n\r\n               -  nystagmus\r\n\r\n               -  dissociated vertical deviation\r\n\r\n          5. Vertical deviation in any gaze direction greater than 5\r\n\r\n          6. Incomitance with more than 5 of difference between the left and right horizontal gaze\r\n             direction\r\n\r\n          7. Previous strabismus surgery\r\n\r\n          8. Previous Botulinum toxin treatment on extraocular muscles\r\n\r\n          9. Presence of ophthalmic pathologies significantly preventing binocular functions.\r\n\r\n             A significant alteration of binocular function is assumed if vision is smaller than\r\n             0.1 or the visual field has a horizontal diameter of less than 20.\r\n\r\n         10. Pregnancy. A negative pregnancy test before randomization is required for all women of\r\n             child-bearing potential.\r\n\r\n         11. Preterm children born before 36 weeks of gestation.\r\n      ","sponsor":"University Hospital Inselspital, Berne","sponsor_type":"Other","conditions":"Acquired Esotropia","interventions":[{"intervention_type":"Drug","name":"Drug: Botulinum toxin type A","description":"Botulinum toxin injection in the horizontal extraocular muscles."},{"intervention_type":"Procedure","name":"Procedure: Strabismus surgery","description":"Strabismus surgery on the horizontal extraocular muscles"}],"outcomes":[{"outcome_type":"primary","measure":"Number of patients with presence of binocular vision","time_frame":"At 18 months","description":"Presence of binocular vision is a binary variable set to yes when either of the following criteria is fulfilled:\r\nNo eye movement can be observed in the simultaneous prism covertest, performed according to the study specific SOP for full orthoptic workup, for both eyes measured at distance. This proves orthotropia and thus binocular vision can be assumed.\r\nAn esotropia of less than 5° is observed in the covertest at distance AND at near. In addition at least one binocular test demonstrates binocular vision. This proves compensated microstrabismus with anomalous retinal correspondence.\r\nBinocular tests:\r\nLang-Stereotest\r\nButterfly- Stereotest\r\nTitmus test\r\nBagolini striated glasses test\r\nTNO-Test\r\nPencil-Test"},{"outcome_type":"secondary","measure":"Number of patients with second intervention","time_frame":"At 12 months, at 18 months","description":"Rescue surgery in Botox-based treatment arm and second surgery in surgery arm"},{"outcome_type":"secondary","measure":"Number of patients with binocular vision","time_frame":"At 12 months","description":"Presence of binocular vision is a binary variable set to yes when either of the following criteria is fulfilled:\r\nNo eye movement can be observed in the simultaneous prism covertest, performed according to the study specific SOP for full orthoptic workup, for both eyes measured at distance. This proves orthotropia and thus binocular vision can be assumed.\r\nAn esotropia of less than 5° is observed in the covertest at distance AND at near. In addition at least one binocular test demonstrates binocular vision. This proves compensated microstrabismus with anomalous retinal correspondence.\r\nBinocular tests:\r\nLang-Stereotest\r\nButterfly- Stereotest\r\nTitmus test\r\nBagolini striated glasses test\r\nTNO-Test\r\nPencil-Test"},{"outcome_type":"secondary","measure":"Number of patients with incomitance","time_frame":"At 12 months, at 18 months","description":"Incomitance is here defined as the absolute difference of strabismus angle measured with the alternate prism cover test at 25° left gaze and the angle measured at 25° right gaze"},{"outcome_type":"secondary","measure":"Number of patients with treatment-specific presence of binocular vision","time_frame":"At 12 months, at 18 months","description":"For this outcome patients with a second intervention are defined as failures (no)."},{"outcome_type":"secondary","measure":"Number of surgeries per participant","time_frame":"At 12 months, at 18 months"},{"outcome_type":"secondary","measure":"Number of surgeries needed per successful outcome","time_frame":"At 12 months, at 18 months","description":"Successful outcome = binocular vision"},{"outcome_type":"secondary","measure":"Change in strabismus angle, measured in percent","time_frame":"At 12 months, at 18 months","description":"Measured as percentage of preoperative deviation from baseline. The strabismus angle measured with the alternate prism cover test, performed in primary position at distance is used. Change of deviation in percent of preoperative deviation is calculated as follows:\r\n100*(preoperative deviation - postoperative deviation) / preoperative deviation"},{"outcome_type":"secondary","measure":"Binocular function, measured in arc seconds","time_frame":"At 12 months, at 18 months","description":"When binocular vision is present, the binocular function is the best stereoscopic acuity, measured in arc seconds, achieved for any of the below mentioned tests.\r\nLang-Stereotest\r\nButterfly- Stereotest\r\nTitmus test\r\nBagolini striated glasses test\r\nTNO-Test\r\nPencil-Test"},{"outcome_type":"other","measure":"Total duration of binocular vision (exploratory outcome)","time_frame":"At 12 months, at 18 months","description":"The duration is calculated as the sum of time periods between consecutive assessments with presence of binocular vision."},{"outcome_type":"other","measure":"Incidence of short-term adverse events (safety outcome)","time_frame":"Within two weeks of intervention","description":"Adverse event groups that will be evaluated separately are:\r\nPtosis\r\nDouble vision\r\nSubjective post-treatment discomfort/pain\r\nNew vertical strabismus >1°\r\nLimitations of ocular motility"},{"outcome_type":"other","measure":"Incidence of ocular adverse events","time_frame":"Within 18 months"},{"outcome_type":"other","measure":"Incidence of serious adverse events related to the treatment","time_frame":"Within 18 months"}]}
{"nct_id":"NCT03636685","start_date":"2018-08-15","phase":"Phase 1/Phase 2","enrollment":60,"brief_title":"Study of Anlotinib Plus Chemotherapy as the First-line Treatment in Patients With Advanced NSCLC","official_title":"A Phase I/II Study of Anlotinib Combined With Platinum-based Chemotherapy as the First-line Treatment of Patients With Locally Advanced or Advanced Non-Small Cell Lung Cancer","primary_completion_date":"2019-08-14","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2020-08-14","last_update":"2018-08-17","description":"Non-small cell lung cancer has the highest morbidity and mortality in Chinaand platinum-based chemotherapy is the standard first-line treatment for the wild-type NSCLC,however the overall survival still less than one year.Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2VEGFR3PDGFR and c-Kit, which has strong effect of anti-angiogenesis.This study is aim to evaluate the efficacy and safety of the combination regimen of anlotinib plus platinum-based chemotherapy as first-line treatment for NSCLC.","other_id":"NCC201807006","allocation":"Non-Randomized","intervention_model":"Factorial Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age18~70 years;\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 -2\r\n\r\n          -  Subjects with histologically or cytologically confirmed locally advanced or advanced\r\n             NSCLC\r\n\r\n          -  EGFR\\ALK\\ROS1 wildtype or unknown,or patients with EGFR\\ALK\\ROS1 mutations but refuse\r\n             to receive corresponding inhibitors' treatment\r\n\r\n          -  No indications for radiation therapy\r\n\r\n          -  Previously chemotherapy naive or postoperative adjuvant chemotherapy ended more than 1\r\n             year\r\n\r\n          -  Subjects with at least one measurable lesion as defined by RECIST (version 1.1),which\r\n             is confirmed by computed tomography (CT) scan or MRI\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Small Cell Lung Cancer\r\n\r\n          -  central lung squamous carcinoma along with cavum, or non-small cell lung cancer along\r\n             with hemoptysis (>50ml/day)\r\n\r\n          -  Within 30 days before enrollment, the patient had used any chemotherapy drugs in the\r\n             previous treatment regimen or clinical study; Or, within 14 days before the first\r\n             administration of the study therapy, the patient has used any targeted anticancer\r\n             drugs in the previous treatment regimen or clinical study; Or stop other experimental\r\n             drugs or cancer drugs for less than five half-life of the drug\r\n\r\n          -  Previous use of anti-angiogenic drugs (such as anlotinib, apatinib, bevacizumab,\r\n             endostar, etc.)\r\n\r\n          -  have got non remissive toxic reactions derived from previous therapies, which is over\r\n             level 1 in CTC AE (4.0), alopecia NOT included\r\n\r\n          -  Spinal cord compression or symptomatic and untreated brain metastases (asymptomatic,\r\n             stable, no need for steroid treatment for 4 weeks before study start)\r\n\r\n          -  with kinds of factors which affect oral medicine (e.g. failing to swallow,\r\n             gastrointestinal tract getting resected, chronic diarrhea and ileus)\r\n\r\n          -  Previous histories include: interstitial pneumonia, drug-induced interstitial\r\n             pneumonia, radiation pneumonia requiring steroid treatment, and clinically proven\r\n             active interstitial pneumonia\r\n\r\n          -  get arterial/venous thrombosis within 6 months, such as cerebrovascular accidents\r\n             (including temporary ischemic stoke), prevenous thrombosis, and pulmonary embolism\r\n\r\n          -  Have suffered from hemorrhagic disease or coagulation dysfunction\r\n\r\n          -  diagnosed with disease which will severely endanger the security of patients or\r\n             influence the completion of this research\r\n      ","sponsor":"Chinese Academy of Medical Sciences","sponsor_type":"Other","conditions":"NSCLC|Adenocarcinoma|Squamous Cell Carcinoma","interventions":[{"intervention_type":"Drug","name":"Drug: Anlotinib combined with pemetrexed and carboplatin, phase I","description":"Non-squamous cell lung cancer, Anlotinib Plus PC\r\nThis study will include a sequential evaluation of 3 subjects per dose group. low-dose groups: Anlotinib 8mg per day plus pemetrexed and carboplatin. middle-dose groups: Anlotinib 10mg per day plus pemetrexed and carboplatin. high-dose groups: Anlotinib 12mg per day plus pemetrexed and carboplatin to determine the appropriate dose of anlotinib in combination with paclitaxel and carboplatin"},{"intervention_type":"Drug","name":"Drug: Anlotinib combined with paclitaxel and carboplatin, phase I","description":"Squamous cell lung cancer, Anlotinib plus TC\r\nThis study will include a sequential evaluation of 3 subjects per dose group. low-dose groups: Anlotinib 8mg per day plus paclitaxel and carboplatin. middle-dose groups: Anlotinib 10mg per day plus paclitaxel and carboplatin. high-dose groups: Anlotinib 12mg per day plus paclitaxel and carboplatin to determine the appropriate dose of anlotinib in combination with paclitaxel and carboplatin"},{"intervention_type":"Drug","name":"Drug: Anlotinib combined with pemetrexed and carboplatin, phase II","description":"Anlotinib: established dose QD PO d1-14, pemetrexed,carboplatin, 21 days per cycle after 4-6 cycles, Anlotinib p.o, qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent"},{"intervention_type":"Drug","name":"Drug: Anlotinib combined with paclitaxel and carboplatin, phase II","description":"Anlotinib :established dose QD PO d1-14, paclitaxel,carboplatin, 21 days per cycle\r\nafter 4-6 cycles, Anlotinib p.o, qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent"}],"outcomes":[{"outcome_type":"primary","measure":"Progress free survival (PFS)","time_frame":"From date of enrollment until the date of first documented progression or date of death from any cause,whichever came first.up to 12 months","description":"progression free survival"},{"outcome_type":"secondary","measure":"Objective Response Rate (ORR)","time_frame":"each 21 days up to the toxicity or PD (up to 24 months)","description":"Objective Response Rate"},{"outcome_type":"secondary","measure":"Disease Control Rate (DCR)","time_frame":"each 42 days up to intolerance the toxicity or PD (up to 24 months)","description":"Disease Control Rate"},{"outcome_type":"secondary","measure":"Overall Survival (OS)","time_frame":"From enrollment until death (up to 36 months)","description":"Overall survival"},{"outcome_type":"secondary","measure":"Number of Participants with Adverse Events as a Measure of Safety and Tolerability (Safety)","time_frame":"Time Frame: each 21 days up to the toxicity or PD (up to 36 months)","description":"Number of Participants with Adverse Events as a Measure of Safety and Tolerability"}]}
{"nct_id":"NCT03621345","start_date":"2018-08-15","phase":"N/A","enrollment":60,"brief_title":"Bilateral Ultrasound-Guided Erector Spinae Plane Block For Postoperative Analgesia in Breast Reduction Surgery","official_title":"Bilateral Ultrasound-Guided Erector Spinae Plane Block For Postoperative Analgesia in Breast Reduction Surgery: A Prospective, Randomized and Controlled Trial","primary_completion_date":"2019-08-15","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-09-01","last_update":"2018-08-08","description":"Erector spinae plane (ESP) block is a novel block developed by Forero to treat severe neuropathic pain and was firstly reported in 2016. Anatomical and radiological investigations in fresh cadavers indicate that its site of action is likely at the dorsal and ventral rami of the thoracic spinal nerves. The ESP block has a clear and simple sonoanatomy, it is easy to perform, not time consuming and generally well tolerated by the patients. So, the investigators believed that the ESP block may be an effective and safer alternative to paravertebral block, epidural analgesia and other myofascial thoracic wall blocks in breast surgery and designed a prospective, randomised, placebo-controlled trial for pain management.","other_id":"CukurovaUniv","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  American Society of Anesthesiologists (ASA) I-II, 18-65 years of age, adult, female\r\n             patients undergoing elective breast reduction surgery\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Coagulopathy\r\n\r\n          -  Allergy to amide-type local anesthetics\r\n\r\n          -  Infection at the ESP block injection site\r\n\r\n          -  Severe obesity (BMI > 35 kg/m2)\r\n\r\n          -  Liver or renal deficiency\r\n\r\n          -  Patients with anatomical deformities\r\n\r\n          -  Recent use of analgesic drugs\r\n\r\n          -  Patient refusal or inability to consent\r\n      ","sponsor":"Cukurova University","sponsor_type":"Other","conditions":"Postoperative Pain|Breast Hypertrophy","interventions":[{"intervention_type":"Procedure","name":"Procedure: Erector spinae plane block","description":"Ultrasound guided bilateral erector spinae plane block will be administered. An intravenous patient control analgesia device with morphine will be given to patients."},{"intervention_type":"Other","name":"Other: sham block","description":"A sham block will be applied. Skin will be infiltrated with local anesthetics, and 2 mL subcutaneous saline injection will be applied.An intravenous patient control analgesia device with morphine will be given to patients."}],"outcomes":[{"outcome_type":"secondary","measure":"Supplemental and rescue analgesic requirement","time_frame":"24 hours","description":"Total supplemental and rescue analgesic consumption"},{"outcome_type":"secondary","measure":"Patient satisfaction assessment","time_frame":"At the postoperative 24th hour","description":"It will be assessed with patient satisfaction scale classified as 'excellent': no pain, NRS=0; 'good': very mild pain, NRS=1-2; 'moderate': mild pain, NRS=3-4."},{"outcome_type":"secondary","measure":"Bilateral shoulder mobility","time_frame":"Preoperative and postoperative 4th, 8th, 12th, and 24th hours","description":"It will be assessed with ability of shoulder abduction degree"},{"outcome_type":"secondary","measure":"Length of stay in hospital","time_frame":"Until discharge from hospital, up to 7 days postoperatively","description":"Duration of length of stay in hospital will be recorded"},{"outcome_type":"secondary","measure":"Rate of block related complications","time_frame":"Until discharge from hospital, up to 7 days postoperatively","description":"Rate of block related complications such as hematoma, nerve deficit, pneumothorax etc. will be recoded."},{"outcome_type":"primary","measure":"Postoperative morphine consumption","time_frame":"24 hours","description":"Morphine consumption in Patient Controlled Analgesia device"},{"outcome_type":"secondary","measure":"Intraoperative anesthetic consumption","time_frame":"During operation time","description":"Intraoperative total remifentanil, pentothal, desflurane consumption"},{"outcome_type":"secondary","measure":"Extubation and recovery time","time_frame":"Through surgical operation completion","description":"Using modified aldrete score"},{"outcome_type":"secondary","measure":"Pain assessed by NRS","time_frame":"24 hours","description":"Numeric rating scale (NRS) at rest and in motion will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. \"no pain\") to '10' representing the other pain extreme (e.g. \"pain as bad as you can imagine\" or \"worst pain imaginable\")."},{"outcome_type":"secondary","measure":"Degree of sedation","time_frame":"24 hours","description":"Ramsay Sedation Scale (RSS) will be used to assess degree of sedation. The RSS was designed as a test of arousability. The RSS scores sedation at six different levels, according to how arousable the patient is. The RSS defines the conscious state from a level 1: the patient is anxious, agitated or restless, through the continuum of sedation to a level 6: the patient is completely unresponsive."},{"outcome_type":"secondary","measure":"Rate of opioid related side effects","time_frame":"24 hours","description":"Opioid related side effects such as nause/vomiting, pruritis, bradycardia, hypotension will be evaluated at intervals up to 24 hours."}]}
{"nct_id":"NCT03095495","start_date":"2018-08-14","phase":"N/A","enrollment":350,"brief_title":"High Flow Nasal Cannula Therapy in Bronchiolitis : Early vs Rescue","official_title":"Heated Humidified High Flow Nasal Cannula (HHHFNC) For Acute Moderate to Severe RSV-Bronchiolitis in Infants Younger Than 3 Months Old: Early Versus Rescue","primary_completion_date":"2023-02-28","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-06-30","last_update":"2021-08-26","description":"The enrolled RSV-bronchiolitis patients will be randomized into two arms , the early HHHFNC group and the standard therapy group with rescue HHHFNC to study the efficacy of this treatment.","other_id":"16036/16","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","maximum_age":0.25,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Previously healthy infants with age 0-3 months and gestational age 30 weeks admitted\r\n             to the short stay unit with RSV positive bronchiolitis and clinical severity score 4\r\n             on Wang clinical severity scale.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Gestational age less than 30 weeks.\r\n\r\n          2. Previous history of wheezing.\r\n\r\n          3. Use of steroid within 48 hours of presentation.\r\n\r\n          4. History of chronic lung disease.\r\n\r\n          5. Infants admitted directly to ICU.\r\n\r\n          6. Prior invasive or non-invasive ventilatory support.\r\n\r\n          7. Tracheostomy.\r\n\r\n          8. Nasogastric tubes in situ on admission.\r\n\r\n          9. Upper airway abnormality (like choanal atresia and midfacial anomalies).\r\n\r\n         10. Immunodeficient children.\r\n\r\n         11. History of cardiac disease, renal disease or liver disease.\r\n\r\n         12. History of neuromuscular disorder.\r\n      ","sponsor":"Hamad Medical Corporation","sponsor_type":"Industry","conditions":"Bronchiolitis|Respiratory Syncytial Virus (RSV)","interventions":[{"intervention_type":"Device","name":"Device: Heated Humidified High Flow Nasal Cannula","description":"HHHFNC therapy is a simple to use system that delivers warm and moist air/oxygen mixture at high flow rates that generate positive airway pressure"},{"intervention_type":"Device","name":"Device: Standard Therapy (Low Flow Nasal Cannula)","description":"will be used only if the patient needs oxygenation and Rescue HHHFNC will be used if the patient needs PICU"}],"outcomes":[{"outcome_type":"primary","measure":"The rate of Pediatric Intensive Care Unit (PICU) admissions","time_frame":"Through study completion, an average of 3 year","description":"The rate of Pediatric Intensive Care Unit admissions"},{"outcome_type":"secondary","measure":"Mean length of stay (LOS)","time_frame":"Through study completion, an average of 3 year","description":"Geometric mean length of stay in the short stay unit"},{"outcome_type":"secondary","measure":"Bronchiolitis Severity Score (BSS)","time_frame":"Up to 72 hours","description":"Bronchiolitis Severity Score at 4, 8, 12, 24, 36, 48, 72 hours"},{"outcome_type":"secondary","measure":"Percentage of revisit, infirmary short-stay and admission to the hospital or PICU","time_frame":"2 weeks after discharge","description":"Percentage of revisit, infirmary short-stay and admission to the hospital or PICU for the same illness on follow up for two weeks post discharge"},{"outcome_type":"secondary","measure":"Transcutaneous Partial Pressure of Carbon Dioxide (PtcCO2)","time_frame":"Up to 72 hours","description":"Transcutaneous Partial Pressure of Carbon Dioxide (PtcCO2) at 4,8,12,24,36,48,72 hours"},{"outcome_type":"secondary","measure":"Percentage of patients who are on the standard therapy arm and required ICU admission, but improved after the rescue HHHFNC in the ED","time_frame":"1 hour after starting of rescue HHHFNC","description":"Percentage of patients who are on the standard therapy arm and required ICU admission, but improved after the rescue HHHFNC in the ED"}]}
{"nct_id":"NCT03207347","start_date":"2018-08-13","phase":"Phase 2","enrollment":47,"brief_title":"A Trial of Niraparib in BAP1 and Other DNA Damage Response (DDR) Deficient Neoplasms (UF-STO-ETI-001)","official_title":"A Phase II Trial of the PARP Inhibitor, Niraparib, in BAP1 and Other DNA Damage Response (DDR) Pathway Deficient Neoplasms (UF-STO-ETI-001)","primary_completion_date":"2022-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-12-31","last_update":"2021-08-13","description":"This open-label, non-randomized study will investigate the use of niraparib in patients with tumors known to have mutations in BAP1 and other select DNA damage response pathway genes.","other_id":"UF-STO-ETI-001","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Patients in both cohorts will receive niraparib.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age 18 years\r\n\r\n          -  Histologically confirmed clinical diagnosis of incurable cancer\r\n\r\n          -  Confirmed diagnosis of uveal melanoma, mesothelioma, renal cell carcinoma (clear cell\r\n             subtype), or cholangiocarcinoma (Cohort A only)\r\n\r\n          -  Known DNA damage repair mutation including any one of the following: ARID1A, ATM, ATR,\r\n             BACH1 (BRIP1), BAP1, BARD1, BLM, CHEK1, CHEK2, CDK2, CDK4, ERCC, FAM175A, FEN1, IDH1,\r\n             IDH2, MRE11A, NBN (NBS1), PALB2, POLD1, PRKDC (DNA-PK) PTEN, RAD50, RAD51, RAD52,\r\n             RAD54, RPA1, SLX4, WRN, or XRCC. Only CLIA certified next generation sequencing (NGS)\r\n             assays are acceptable. Variants of unknown significance (VUS) will be allowed to\r\n             enroll on study. (Cohort B only)\r\n\r\n          -  Prior treatment with standard systemic therapy (must have exhausted or declined all\r\n             known and currently approved effective life prolonging therapies)\r\n\r\n          -  Must have formalin-fixed paraffin embedded (FFPE) tissue available for research\r\n             purposes. Tissue must have been obtained within the last 3 years from a core or\r\n             excisional biopsy.\r\n\r\n          -  Measurable disease by RECIST (v 1.1) criteria\r\n\r\n          -  Adequate organ function\r\n\r\n          -  ECOG Performance Status of 0-1\r\n\r\n          -  Life expectancy  12 weeks\r\n\r\n          -  Women of childbearing potential must have a negative serum or urine pregnancy test\r\n             within 7 days prior to the first dose AND be using an adequate method of contraception\r\n             to avoid pregnancy throughout the study and for at least 180 days after the last dose\r\n             of study drug to minimize the risk of pregnancy.\r\n\r\n          -  Males with female partners of child-bearing potential must agree to use\r\n             physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy)\r\n             throughout the study and should avoid conceiving children for 180 days following the\r\n             last dose of study drug. In addition, men must not donate sperm during niraparib\r\n             therapy and for 180 days after receiving the last dose of niraparib.\r\n\r\n          -  Subjects must agree to not donate blood during the study or for 90 days after the last\r\n             dose of study treatment.\r\n\r\n          -  Subjects receiving oral corticosteroids may continue as long as their dose is stable\r\n             for least 4 weeks prior to initiating protocol therapy.\r\n\r\n          -  If a new biopsy is needed for diagnostic reasons, the biopsy must be performed from a\r\n             tumor site that is not the only site of measurable disease.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior exposure to PARP inhibitors\r\n\r\n          -  Subject has received or is planning to receive live vaccines within 30 days prior to\r\n             the first dose of oral treatment and while participating in the trial\r\n\r\n          -  Known BRCA1 or BRCA2 mutation\r\n\r\n          -  Pathologic diagnosis of prostate cancer as the cancer to be treated in cohort B\r\n\r\n          -  Simultaneous enrollment in any other interventional clinical trial\r\n\r\n          -  Major surgery  3 weeks of study enrollment (Subject must have recovered from any\r\n             effects of any major sugery.)\r\n\r\n          -  Investigational therapy  4 weeks of first day of dosing of study drug\r\n\r\n          -  Radiotherapy to > 20% of the bone marrow within 4 weeks of the first dose of study\r\n             drug\r\n\r\n          -  Known hypersensitivity to the components of niraparib or the excipients\r\n\r\n          -  Platelet or red blood cell transfusion  4 weeks of first dose of study drug\r\n\r\n          -  Colony-stimulating factors within 4 weeks prior to starting protocol therapy\r\n\r\n          -  More than one active malignancy at the time of enrollment (Subjects with a prior or\r\n             concurrent malignancy whose natural history or treatment does not have the potential\r\n             to interfere with the safety or efficacy assessment of the investigational regimen [as\r\n             determined by the treatment physician and approved by the PI] may be included).\r\n\r\n          -  Known, active symptomatic brain or leptomeningeal metastases\r\n\r\n          -  Subject has had any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to\r\n             prior chemotherapy that persisted > 4 weeks and was related to the most recent\r\n             treatment.\r\n\r\n          -  Known history of myelodysplastic syndrome or acute myeloid leukemia\r\n\r\n          -  Females or males of childbearing potential who are unwilling or unable to use an\r\n             acceptable method of birth control to avoid pregnancy for the entire study period and\r\n             for at least 180 days after the last dose of study drug.\r\n\r\n          -  Females who are pregnant or breastfeeding\r\n\r\n          -  History of any other disease, metabolic dysfunction, physical examination finding, or\r\n             clinical laboratory finding giving reasonable suspicion of a disease or condition that\r\n             contraindicates the use of protocol therapy or that might affect the interpretation of\r\n             the results of the study or that puts the subject at high risk for treatment\r\n             complications, in the opinion of the treating physician or study PI.\r\n\r\n          -  Prisoners or subjects who are involuntarily incarcerated.\r\n\r\n          -  Subjects who are compulsorily detained for treatment of either a psychiatric or\r\n             physical illness.\r\n\r\n          -  Subjects demonstrating an inability to comply with the study and/or follow-up\r\n             procedures\r\n      ","sponsor":"University of Florida","sponsor_type":"Other","conditions":"Mesothelioma|Uveal Melanoma|Renal Cell Carcinoma|Cholangiocarcinoma","interventions":[{"intervention_type":"Drug","name":"Drug: Niraparib","description":"Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle."}],"outcomes":[{"outcome_type":"primary","measure":"Objective Response Rate (ORR)","time_frame":"1 year","description":"Determine the objective response rate (ORR) for patients with BAP1 and other DNA double- strand break repair pathway mutations treated with niraparib"},{"outcome_type":"secondary","measure":"Progression Free Survival","time_frame":"1 year","description":"Determine the median progression free survival"},{"outcome_type":"secondary","measure":"Progression Free Survival","time_frame":"3 months","description":"Determine the progression free survival at 3 months in each cohort and histologic subset of subjects"},{"outcome_type":"secondary","measure":"Progression Free Survival","time_frame":"6 months","description":"Determine the progression free survival at 6 months in each cohort and histologic subset of subjects"},{"outcome_type":"secondary","measure":"Overall Survival","time_frame":"2 years","description":"Estimate the median overall survival"},{"outcome_type":"secondary","measure":"Number of participants with treatment-related adverse events, as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0","time_frame":"1 year","description":"Determine the incidence, severity, and reversibility of the toxicities of niraparib using CTCAE v4.0"},{"outcome_type":"other","measure":"Number of DNA repair mechanism deficiencies","time_frame":"1 year","description":"Explore the impact that specific DNA repair mechanism deficiencies have on tumor PARP inhibition"},{"outcome_type":"other","measure":"Biomarker identification","time_frame":"1 year","description":"Explore alternate biomarkers that predict response to PARP inhibition"}]}
{"nct_id":"NCT03611075","start_date":"2018-08-13","phase":"Phase 1","enrollment":144,"brief_title":"A Study to Evaluate Scales for Repetitive and Restricted Behaviors in Children, Adolescents, and Adults With Autism Spectrum Disorder (ASD)","official_title":"Study to Evaluate and Explore Scales for Repetitive and Restricted Behaviors and Digital Biomarkers in Children, Adolescents, and Adults With Autism Spectrum Disorder (ASD)","primary_completion_date":"2020-05-21","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-05-21","last_update":"2021-07-23","description":"This is a non-drug study seeking to characterize different scales to measure repetitive and restrictive behaviors in different ASD sub-populations over time. This study will also explore the use of digital biomarkers.","other_id":"BP40331","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":5,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria for All Participants\r\n\r\n          -  Males and females\r\n\r\n          -  Availability of a parent or other reliable caregiver. The same person must agree to\r\n             accompany the participant to all clinic visits and provide information about the\r\n             participant's behavior and symptoms\r\n\r\n        Inclusion Criteria for Participants with Autism Spectrum Disorders (ASD)(Diagnostic\r\n        evaluations will be completed at study site by research staff and supervised by a licensed\r\n        psychologist)\r\n\r\n          -  Age: 5-45 years\r\n\r\n          -  Diagnosis of ASD based on the Diagnostic and Statistical Manual of Mental Disorders\r\n             (DSM-5), and the Autism Diagnostic Observation Schedule (ADOS-2).\r\n\r\n          -  Children's Yale-Brown Obsessive Compulsive Scale modified for ASD (CY-BOCS-ASD) total\r\n             score of at least 12\r\n\r\n          -  Clinical Global Impression-Severity (CGI-S) scale of at least 4 about participant's\r\n             current autism severity\r\n\r\n          -  Intelligence quotient (IQ) score of 50 or above as assessed by the Abbreviated\r\n             Intelligence Quotient (ABIQ) SB5 scale\r\n\r\n          -  All medications and treatments are expected to be stable for the duration of the study\r\n\r\n        Inclusion Criteria for Typically Developing (TD) Healthy Participants\r\n\r\n        -TD participants aged 5-45 years\r\n\r\n        Exclusion Criteria for All Participants\r\n\r\n          -  Participation in an in investigational drug or device study within 4 weeks or 5 times\r\n             the half-life of the investigational molecule prior to screening, and participant is\r\n             not expected to enroll in any other trial during the study\r\n\r\n          -  Co-occurring disease, condition, or treatment that might interfere with the conduct of\r\n             the study or pose an unacceptable risk to the participant\r\n\r\n          -  Unstable or uncontrolled clinically significant psychiatric and/or neurological\r\n             disorder that may interfere with study objectives\r\n\r\n        Exclusion Criteria for Participants with ASD -Known \"syndromic\" ASD (e.g. Fragile X\r\n        syndrome, Angelman syndrome, Prader-Willi, Rett's syndrome, tuberous sclerosis, Dup15q\r\n        syndrome) History of alcohol misuse and/or illicit drug use during the last 12 months of\r\n        the study\r\n\r\n        Exclusion Criteria for TD Healthy Participants\r\n\r\n        -TD healthy participants with a first-degree relative with ASD\r\n      ","sponsor":"Hoffmann-La Roche","sponsor_type":"Industry","conditions":"Autism Spectrum Disorder","interventions":[{"intervention_type":"Other","name":"Other: No Intervention","description":"No interventions are administered in this study"}],"outcomes":[{"outcome_type":"primary","measure":"Children's Yale-Brown Obsessive Compulsive Scale Modified for Autism Spectrum Disorder (CY-BOCS-ASD) - Total Score","time_frame":"Baseline, Weeks 2 and 12","description":"The CY-BOCS-ASD is where the interviewer asks the parent/caregiver about past and present repetitive behaviors, guided by the revised repetitive behavior checklist with a list of 25 behaviors, classified into the following categories: Hoarding/ritualistic behavior, Sensorymotor and arranging, Insistence on routines /Self-injurious behaviors, Stereotypy and Restricted interests. This checklist was expanded to include repetitive behaviors commonly seen in children with ASD. A target symptom list comprising the four most troublesome behaviors is established by the interviewer. The severity (0 to 4) of each target behavior is rated for the following five items: time spent, interference, distress, resistance and degree of control to generate a total score (0-20). The ratings evaluate the symptom severity over the past week and are based on the information collected from the child and parent/caregiver during the interview. Values at visits are reported."},{"outcome_type":"primary","measure":"Montefiore Einstein Rigidity Scale (MERS-R)","time_frame":"Baseline, Weeks 2 and 12","description":"The MERS-R was to assess 3 domains of rigid behavior in children and adults. It's a clinician-administered scale in which the clinician uses all available information to rate. Each domains is assessed separately, during examples are discussed and related behaviors are probed for more individualized exemplars. A list of relevant behaviors is compiled for each domain, and ratings for the items are based on the average occurrence of the behaviors over the past one week. Total values at visits are reported and domains are assessed: ASD: 1. Behavioral Rigidity (e.g., insistence on sameness, things must be done in his/her way) 2. Cognitive Rigidity (e.g., inflexible adherence to rules) 3. Protest (in response to deviation from rigidity; e.g., verbal objection, tantrum, physical aggression). These domain scores can range from 0 (no problems) to 4 (severe problems). The total score represents the sum of the domain scores ranging from 0-48, where higher scores indicate more severe problems."},{"outcome_type":"primary","measure":"Repetitive Behavior Scale-Revised (RBS-R)","time_frame":"Baseline, Weeks 2 and 12","description":"The Repetitive Behavior Scale-Revised (RBS-R) is a 43-item caregiver-report questionnaire to measure breadth of repetitive behaviors in children, adolescents, and adults with ASD. It provides a quantitative measure of the full spectrum of repetitive behaviors of 6 subscales: Stereotype, Self-injurious, Compulsive, Ritualistic, Sameness and Restricted Behaviors. Caregivers are asked to read a list of behaviors and choose for each item a score that best describes how much of a problem the behavior has been over the last month. Behaviors are rated on a 4-point scale: 0-Behavior does not occur, 1-Behavior occurs and is a mild problem, 2-Behavior occurs and is a moderate problem, 3-Behavior occurs and is a severe problem. The total score is the sum of all 43 items and can range from 0 to 129. Higher scores indicate more severe problems with repetitive behaviors. The sums of score values at visits are reported."},{"outcome_type":"primary","measure":"Repetitive Behavior Questionnaire for Children (RBQ-2)","time_frame":"Baseline, Weeks 2 and 12","description":"The RBQ-2 is a 20 items questionnaire to assess the spectrum of restricted and repetitive behaviors observed in individuals with ASD such as repetitive motor movements, rigidity/adherence to routine, preoccupation with restricted patterns of interest and unusual sensory Interest (Leekman et al 2007; Honey et al 2012). The RBQ-2 exists in two different versions, a caregiver reported version for pediatric subjects RBQ-2 and a participant-reported version for adults RBQ-2A (Barrett et al 2015). The RBQ-2, the caregiver version is used for this reported data set. To ensure for this study a comparable the mean total score is calculated as the sum of the items, total scores at visits are reported. For the RBQ-2, the possible total score can range between 20-60, with higher scores indicating more frequent RRB."},{"outcome_type":"primary","measure":"Restricted Behavior Questionnaire for Adults (RBQ-2A)","time_frame":"Baseline, Weeks 2 and 12","description":"The RBQ-2 is a 20 items questionnaire to assess the spectrum of restricted and repetitive behaviorsobserved in individuals with ASD such as repetitive motor movements, rigidity/adherence to routine, preoccupation with restricted patterns of interest and unusual sensory Interest (Leekman et al 2007; Honey et al 2012). The RBQ-2 exists in two different versions, a caregiver reported version for pediatric subjects RBQ-2 and a participant-reported version for adults RBQ-2A (Barrett et al 2015). The RBQ-2, the caregiver version is used for this reported data set. Total score is calculated as the sum of the items, total scores at visits are reported. For the RBQ-2A, the possible total score can range between 20 to 60, with higher scores indicating more frequent and severe RRB."},{"outcome_type":"primary","measure":"Childhood Routines Inventory-Revised (CRI-R)","time_frame":"Baseline, Weeks 2 and 12","description":"The CRI-R (for children and adolescents) and ARI (for adults) were developed together and are closely related scales (Evans et al 2017).The CRI-R and ARI questionnaires capture a wide range of restricted and repetitive behaviors, including stereotypies, tics, compulsions, habits, sensory sensitivities, and focused interests, in the context of typical and atypical development in children, adolescents and adults across the entire lifespan. All items will be answered on a five-point Likert scale from not at all/ never, a little/rarely, somewhat/ sometimes, quite a lot/ often, and very much / always. The caregiver-completed CRI-R scale for pediatric subjects includes 62 items. Total score is calculated as the sum of the items, total scores at visits are reported.\r\nFor the CRI-R, the possible total score can range between 62 - 310, with higher scores indicating more frequent RRB."},{"outcome_type":"primary","measure":"Adult Routines Inventory (ARI)","time_frame":"Baseline, Weeks 2 and 12","description":"The CRI-R (for children and Adolescents) and ARI (for adults) were developed together and are closely related scales (Evans et al 2017).The CRI-R and ARI questionnaires capture a wide range of RRBs, including stereotypies, tics, compulsions, habits, sensory sensitivities, and focused interests, in the context of typical and atypical development in children, adolescents and adults across the entire lifespan. All items will be answered on a five-point Likert scale from not at all/ never, a little/rarely, somewhat/ sometimes, quite a lot/ often, and very much / always. The caregiver-completed CRI-R scale for pediatric subjects includes 62 items. The participant-reported ARI scale for adult subjects includes 55 items and will be completed by the participant. Total score is calculated as the sum of the items, mean total scores at visits are reported.\r\nFor the ARI, the possible total score can range between 55-275, with higher scores indicating more frequent RRB."},{"outcome_type":"secondary","measure":"Clinical Global Impression Scales (CGI)","time_frame":"Baseline, Weeks 2 and 12","description":"The CGI rating scales are tools used to evaluate both the severity of illness and change from Baseline (Guy et al 1976). The CGI-S reflects the rater's impression of the participant's current autism severity on a 7-point scale ranging from no symptoms (1) to very severe symptoms (7). The CGI-I is used to assess the clinical change as compared to symptoms at Baseline using a 7-point scale, ranging from very much improved (1) to very much worse (7). For this study modified versions will be used (Busner et al 2007 and 1991; Busner et al 1997). Values at visits are reported."},{"outcome_type":"secondary","measure":"Child's Sleep Habits Questionnaire (CSHQ)","time_frame":"Baseline, Weeks 2 and 12","description":"The CSHQ is a 54-item parent or caregiver-reported measure that enquires about children's sleep habits and possible difficulties with sleep (Owens et al 2000). A subsequent study supported the validity of the CSHQ in children as young as 2 years. Using a 3-point Likert scale parents indicate whether a behavior occurs usually = 3, (i.e. 5 or more times a week),sometimes = 2 (i.e. 2-4 times a week) or rarely = 1 (i.e. 0-1 times a week). The summation of the frequency rating creates the total score, with higher scores reflecting greater sleep disturbances. The total score is calculated as the sum of a subset of 33 items and can range from 33 - 99, with higher scores reflecting greater sleep disturbances. Total scores at each visit are reported."},{"outcome_type":"secondary","measure":"Pittsburg Sleep Quality Index (PSQI)","time_frame":"Baseline, Weeks 2 and 12","description":"The PSQI assesses sleep quality during the previous month (Buysse et al 1989). It consists of 19 self-rated questions. A wide variety of factors relating to sleep quality are assessed, including estimates of sleep duration and latency and the frequency and severity of specific sleep-related problems. These 19 items are grouped into seven component scores, each weighted equally on a 0-3 scale. The global PSQI score has a range of 0-21 and higher scores indicate worse sleep quality. Adult participants with a mental age of at least 10 years and adolescents deemed able to complete the PSQI will complete this scale."},{"outcome_type":"secondary","measure":"Reading the Mind in the Eyes Test -R (RMET-R)","time_frame":"Baseline, Week 12","description":"RMET was used as anchor for the analysis of digital biomarker data and therefore also healthy participants should complete the RMET. However, at study start, it will be decided for each individual participant if the RMET-R or RMET-C should be used or if neither of the two RMET versions is deemed appropriate for the participant.\r\nIn RMET-R, the participants are presented a series of 36 pictures of the eye-region of the face of different individuals, and are asked to choose which of four words best describes what the person in the photograph is thinking or feeling. This test was conceived of as a test of how well the participant can put themselves into the mind of the other person, and \"tune in\" to their mental state. The sum of the correct answers at each visit are reported as the total score. The total score can range from 0-36, and the higher the score, the more the participant can put themselves into the mind of the other person etc."},{"outcome_type":"secondary","measure":"Reading the Mind in the Eyes Test Child -C (RMET-C)","time_frame":"Baseline, Week 12","description":"RMET was used as anchor data for analysis of digital biomarkers and therefore also healthy participants should complete the RMET. However at study start it will be decided for each individual participant if the RMET-R or RMET-C should be used or if neither of the two RMET versions is deemed appropriate for the participant.\r\nIn the shorter pediatric RMET-C, the participants are presented a series of 28 pictures of the eye-region of the face of different individuals, and are asked to choose which of four words best describes what the person in the photograph is thinking or feeling. This test was conceived of as a test of how well the participant can put themselves into the mind of the other person, and \"tune in\" to their mental state. The sum of the correct answers at each visit is reported as total scores.\r\nFor the RMET-C the total score can range from 0-28, and the higher the score, the more the participant can put themselves into the mind of the other person etc."},{"outcome_type":"secondary","measure":"Hamilton Anxiety Rating Scale (HAM-A)","time_frame":"Baseline, Weeks 2 and 12","description":"The HAM-A is a clinician-rated scale to analyze the severity of symptoms of anxiety. The HAM-A consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). The scale is intended for adults, adolescents, and children´(Hamilton et al 1959). The HAM-A will be completed only for adult participants in this study.\r\nEach of the 14 items is scored on a scale of 0 (not present) to 4. (severe) The total score is calculated as the sum of all items. The total score can range from 0-56, where <17 indicates mild severity, 18-24 mild to moderate, ≥ 24 severe anxiety. The total scores at each visit are reported (scores ≤ 7 were considered to represent no/minimal)."},{"outcome_type":"secondary","measure":"Parent Rated Anxiety Scale for ASD (PRAS-ASD)","time_frame":"Baseline, Weeks 2 and 12","description":"PRAS-ASD is a caregiver-rated scale with 25 items to assess the severity of anxiety symptoms in children and adolescents with ASD. Caregivers are asked to describe their child's worries and anxiety-related behaviors over the past two weeks on a 0 to 3-point scale from NONE=not present; MILD=Present sometimes, not a real problem; MODERATE=Often present and a problem; SEVERE=Very frequent and a major problem. A publication about the PRAS-ASD is in preparation (as per personal communication, Prof Dr. Lawrence Scahill at Emory University). The PRAS-ASD will be completed for children and adolescents. Each of the 25 items is scored by the caregiver on a scale of 0 (None) to 3. (severe) The total score is calculated as the sum of all items. The total score can range from 0-75. , where higher scores indicate more severe anxiety. The total scores at each visit are reported."},{"outcome_type":"secondary","measure":"Beck Anxiety Index (BAI)","time_frame":"Baseline, Weeks 2 and 12","description":"The Beck Anxiety Inventory (BAI) consists of 21 self-reported items (four-point scale) used to assess the intensity of physical and cognitive anxiety symptoms during the past week. Scores may range from 0 to 63: minimal anxiety levels (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63). Each item contains four possible responses, which range in severity from 0=not at all to 3=severely, I could barely stand it. Participants are asked to provide answers based on the way they have been feeling over the past month, including the assessment day. Adult participants were asked to complete the BAI. Adolescent participants completed the BAI if deemed appropriate by Investigator for the individual participant based on mental age. The BAI is a self-administered scale and the sum values at visits are reported as total scores. The total score can range from 0-63. The higher score values indicate more anxiety symptoms."},{"outcome_type":"secondary","measure":"Digital Biomarkers","time_frame":"Baseline until study completion (approximately 12 weeks)","description":"It's to measure behaviors and symptoms related to ASD remotely with digital biomarkers, based on adherence (number of participants adhered) to the digital biomarker schedule of assessments. Participants will use a dedicated smartphone and wearable device to perform at-home exploratory measures in Digital Biomarker Adherence measurement. It consisted of surveys and performance outcome measures related to autism-associated symptoms, as well as continuous passive monitoring of participant behavior. Percentage of participants adhered were reported per assessment including Active Test, Conversation, Study Participant Daily Surveys, Support Person, Daily Surveys and Passive Monitoring."},{"outcome_type":"secondary","measure":"Behaviour Rating Inventory of Executive Function for Children (BRIEF)","time_frame":"Baseline, Weeks 2 and 12","description":"The Behaviour Rating Inventory of Executive Function (BRIEF) parent questionnaire was designed to assess executive functioning of children with a wide spectrum of developmental and acquired neurological conditions, such as: Learning disabilities, Low birth weight, Attention-deficit/hyperactivity disorder, Tourette's disorder, Traumatic brain injury, Pervasive developmental disorders/autism (Gioia et al 2000).\r\nThe pediatric Behavior Rating Inventory of Executive Function (BRIEF) consists of 86 caregiver reported items (three -point scale, N=never \"1\", S=sometimes \"2\", O= often \"3\" ) used to assess problems with executive functioning. The total score called global executive composite score which is calculated as the sum of the items and may range from 86 to 258 with higher total scores indicating more problems with executive functioning."},{"outcome_type":"secondary","measure":"Behaviour Rating Inventory of Executive Function for Adults (BRIEF-A)","time_frame":"Baseline, Weeks 2 and 12","description":"The Behaviour Rating Inventory of Executive Function (BRIEF) parent questionnaire was designed to assess executive functioning of children with a wide spectrum of developmental and acquired neurological conditions, such as: Learning disabilities, Low birth weight, Attention-deficit/hyperactivity disorder, Tourette's disorder, Traumatic brain injury, Pervasive developmental disorders/autism (Gioia et al 2000).\r\nThe adult Behavior Rating Inventory of Executive Function (BRIEF-A) consists of 75 caregiver reported items (three -point scale, N=never \"1\", S=sometimes \"2\", O= often \"3\") used to assess problems with executive functioning. The total score called global executive composite score which is calculated as the sum of the items and may range from 75 to 225 with higher total scores indicating more problems with executive functioning."},{"outcome_type":"secondary","measure":"Short Sensory Profile (SSP)","time_frame":"Baseline, Weeks 2 and 12","description":"The Short Sensory Profile (SSP) is a 38-item parent or caregiver reported questionnaire that probes for the effect of sensory processing anomalies on a person's ability to function in daily life. Item responses occur on a five-point Likert-rating scale from 1 (always occurs) to 5 (never occurs). The Short Sensory Profile was based on the Sensory Profile and provides 3 sets of standard scores depending on how the items are clustered: (1) domain scores, (2) factor scores and (3) a total score of all items. Total scores at the visits are reported.\r\nFor the SSP, the possible total score can range between 38-190, with lower scores indicating more severe effect of sensory processing anomalies on a person's ability to function in daily life."},{"outcome_type":"secondary","measure":"Vineland(TM)-II Survey","time_frame":"Baseline, Week 12","description":"The VinelandTM-II measures communication, daily living skills, socialization, motor skills (only in children up to 6 years) and maladaptive (not assessed in this study) behavior of individuals with developmental disabilities. The Survey Interview Form (i.e., semi -structured interview) will be administered to a participant's reliable caregiver in this study, during which the rater or clinician will ask to the caregiver open-ended questions relating to the participant's activities and behavior. Domain scores will be obtained for the individual domains of Socialization, Communication, Daily Living Skills, and motor skills (up to 6 years only) and used to calculate the VinelandTM-II Adaptive Behavior Composite score. Standardized scores on the adaptive behavior composite range from 20-160 with higher scores indicating better adaptive functioning. Values at visits are reported."},{"outcome_type":"secondary","measure":"Pediatric Quality of Life Inventory (PedsQL) Family Impact Scale","time_frame":"Baseline, Weeks 2 and 12","description":"The PedsQL™ Family Impact Module version 2 is a 36-item questionnaire which is completed by the caregiver and encompasses six scales covering 1) Physical Functioning (6 items), 2) Emotional Functioning (5 items), 3) Social Functioning (4 items), 4) Cognitive Functioning (5 items), 5) Communication (3 items), 6) Worry (5 items), and two scales measuring parent reported family functioning; 7) Daily Activities (3 items) and 8) Family Relationships (5 items). For each item a 5-point response scale is utilized (0=never a problem; 4=always a problem). Items are then reverse-scored and linearly transformed to a 0-100 scale (0-100, 1-75, 2-50, 3-25, 4-0), so that higher scores indicate better functioning (less negative impact). Scale Scores are computed as the sum of the items divided by the number of items answered (this accounts for missing data). If more than 50% of the items in the scale are missing, the Scale Score is not computed. Values at visits are reported."},{"outcome_type":"secondary","measure":"PedsQL Core Functioning Scale","time_frame":"Baseline, Weeks 2 and 12","description":"The PedsQL Cognitive Functioning Scale which contains six items will also be completed. The acute participant-completed forms (5 to 7 years, 8 to 12 years, 13 to 18 years, young adults, and adults) with a recall period of 7 days will be employed in this trial. For children aged 8 years and above, the PedsQL items are scored on a five-point Likert-type response scale (0=never a problem; 1=almost never a problem; 2=sometimes a problem; 3=often a problem; and 4=almost always a problem). For children age 5 to 7 years, scoring is based on a three point scale (0=Not at all, 2=Sometimes, 4=A lot). Items will be reverse-scored and linearly transformed to a 0-100 scale (0=100, 1=75, 2=50, 3=25, 4=0), so that higher scores indicate better health-related quality of life. For children aged 5-7 years, an administrator will read out the questions and the child will respond by pointing to one of three smiley faces. The values at visits are reported."},{"outcome_type":"secondary","measure":"PedsQL Cognitive Functioning Scale","time_frame":"Baseline, Week 2 and 12","description":"The PedsQL Cognitive Functioning Scale which contains six items will also be completed. The acute participant-completed forms (5 to 7 years, 8 to 12 years, 13 to 18 years, young adults, and adults) with a recall period of 7 days will be employed in this trial. For children aged 8 years and above, the PedsQL items are scored on a five-point Likert-type response scale (0=never a problem; 1=almost never a problem; 2=sometimes a problem; 3=often a problem; and 4=almost always a problem). For children age 5 to 7 years, scoring is based on a three point scale (0=Not at all, 2=Sometimes, 4=A lot). Items will be reverse-scored and linearly transformed to a 0-100 scale (0=100, 1=75, 2=50, 3=25, 4=0), so that higher scores indicate better health-related quality of life. For children aged 5-7 years, an administrator will read out the questions and the child will respond by pointing to one of three smiley faces. The values at visits are reported."}]}
{"nct_id":"NCT03597737","start_date":"2018-08-10","phase":"N/A","enrollment":21,"brief_title":"Utility of an APP for the Monitoring of Irruptive Oncological Pain","official_title":"Utility of an APP for the Monitoring of Irruptive Oncological Pain","primary_completion_date":"2019-03-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-11-29","last_update":"2021-04-12","description":"The present investigation aims at exploring the effect of including a pain app called Pain Monitor irruptive oncological pain for chronic pain patients' daily monitoring. Two conditions will be set: 1. usual treatment (waiting list) 2. usual treatment + APP","other_id":"OncoApp","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Device Feasibility","masking_description":"None (Open Label)","intervention_model_description":"One condition","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  The patient is over 18 years of age\r\n\r\n          -  Irruptive oncological pain\r\n\r\n          -  The patient has a mobile phone with Android operating system\r\n\r\n          -  The patient has the physical ability to use the application\r\n\r\n          -  The patient does not present psychological and / or cognitive alterations or problems\r\n             with language that make their participation difficult- The patient voluntarily wants\r\n             to participate and signs the informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  The patient is under 18 years\r\n\r\n          -  The patient does not have a mobile phone or has a mobile phone in which Android is not\r\n             the operating system (the app is currently only available for Android for economic\r\n             reasons)\r\n\r\n          -  The patient does not have the physical capacity to use the application\r\n\r\n          -  The patient does not have the capacity to participate due to psychological and / or\r\n             cognitive alterations or problems with language\r\n\r\n          -  The patient does not want to participate\r\n      ","sponsor":"Universitat Jaume I","sponsor_type":"Other","conditions":"Oncology|Pain, Acute|Pain, Chronic","interventions":[{"intervention_type":"Device","name":"Device: Pain APP","description":"pain app Pain Monitor app has been developed by a multidisciplinary pain expert panel, including physicians, psychologists, and nurses. Content has been validated in a previous study and usability has been shown to be excellent."}],"outcomes":[{"outcome_type":"primary","measure":"Change in average pain intensity in the past week assessed by a Numerical Rating Scale in the Brief Pain Inventory-Short Form","time_frame":"Twice (first day of study and 30 days after, at the end of study)","description":"The Brief Pain Inventory-Short Form (BPI-SF) will be used to measure average pain intensity. The item has a response range from 0 (no pain) to 10 (pain as bad as you can imagine). Higher scores represent higher pain intensity levels"},{"outcome_type":"primary","measure":"Change in side effects of pain medication","time_frame":"Twice (first day of study and 30 days after, at the end of study)","description":"A list of the most frequent side effects of pain medication has been created. Responses are dichotomous (0=did not experience the side effect; 1=experienced the side effect)"},{"outcome_type":"secondary","measure":"Change in depression measured by the Sadness scale in the POMS","time_frame":"Twice (first day of study and 30 days after, at the end of study)","description":"The Profile of Mood States (POMS) questionnaire will be used to measure mood. The questionnaire includes 30 items that describe how the participant feels. For this outcome depression scale (5 items) will be used. Each item has a response range from 0 (not at all) to 4 (extremely). Total score ranges from 0 to 20, higher scores represent a worse outcome"},{"outcome_type":"secondary","measure":"Change in anxiety measured by the Tension scale in the POMS","time_frame":"Twice (first day of study and 30 days after, at the end of study)","description":"The Profile of Mood States (POMS) questionnaire will be used to measure mood. The questionnaire includes 30 items that describe how the participant feels. For this outcome anxiety scale (5 items) will be used. Each item has a response range from 0 (not at all) to 4 (extremely). Total score ranges from 0 to 20, higher scores represent a worse outcome"},{"outcome_type":"secondary","measure":"Change in the amount of rescue medication used in the past week","time_frame":"Twice (first day of study and 30 days after, at the end of study)","description":"An item exploring the use of rescue medication in the past week has been created. Responses are numerical (the amount of rescue medication is indicated by participants)"},{"outcome_type":"secondary","measure":"Change in average interference of pain in functioning in the past week measured by a Numerical Rating Scale in the Brief Pain Inventory-Short Form","time_frame":"Twice (first day of study and 30 days after, at the end of study)","description":"The Brief Pain Inventory-Short Form (BPI-SF) will be used to measure pain interference. This questionnaire lists four questions regarding pain intensity and seven regarding pain interference. For this outcome pain interference items will be used. Each item has a response range from 0 (no pain) to 10 (pain as bad as you can imagine). Total score ranges from 0 to 70, higher scores represent a worse outcome"},{"outcome_type":"secondary","measure":"Change in physical health status measured with the Physical Composite Score in the SF12","time_frame":"Twice (first day of study and 30 days after, at the end of study)","description":"12-Item Short-Form Health Survey (SF-12) will be used to measure quality of life. This is a questionnaire composed of two scales: physical and mental health. Each scale has a 0-100 range, with higher scores indicating better health-related quality of life"},{"outcome_type":"secondary","measure":"Change in mental health status measured with the Mental Composite Score in the SF12","time_frame":"Twice (first day of study and 30 days after, at the end of study)","description":"12-Item Short-Form Health Survey (SF-12) will be used to measure quality of life. This is a questionnaire composed of two scales: physical and mental health. Each scale has a 0-100 range, with higher scores indicating better health-related quality of life"},{"outcome_type":"secondary","measure":"Change in neuropathic symptoms","time_frame":"Twice (first day of study and 30 days after, at the end of study)","description":"Dolour Neuropathique 4 (DN4) questionnaire will be used to measure neuropathic symptoms. It is a questionnaire composed of 10 items. Each item is scored as 0 (no presence of neuropathic symptom) or 1 (presence of neuropathic symptom). Total score ranges between 0 and 10. It is considered that a patient suffers pain with a neuropathic component when answers affirmatively to 4 or more items of the questionnaire DN4"}]}
{"nct_id":"NCT03623386","start_date":"2018-08-10","phase":"N/A","enrollment":50,"brief_title":"Effect of Mental Imagery Training on Brain Plasticity and Motor Function in Individuals With Parkinson's Disease","official_title":"Effect of Mental Imagery Training on Brain Plasticity and Motor Function in Individuals With Parkinson's Disease: A Functional MRI Investigation","primary_completion_date":"2023-06-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-12-31","last_update":"2021-06-02","description":"Effect of Mental Imagery Training on Brain Plasticity and Motor Function in Individuals with Parkinson's Disease: A functional MRI investigation.","other_id":"2000023535","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","intervention_model_description":"2 cohort","sampling_method":"","gender":"All","minimum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subjects with a diagnosis of idiopathic PD defined according to the UK Brain Bank\r\n             diagnostic criteria and on a stable dopaminergic medication regimen will be included.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Age < 40 years\r\n\r\n          -  Non-English speaking\r\n\r\n          -  Pregnancy\r\n\r\n          -  Breastfeeding\r\n\r\n          -  Excessive alcohol consumption (> 7 drinks per week for women, > 14 drinks per week for\r\n             men) or substance use\r\n\r\n          -  History of a neurological disorder such as a brain tumor, stroke, central nervous\r\n             system infection, multiple sclerosis, movement disorder (other than PD), or seizures\r\n\r\n          -  History of schizophrenia, bipolar disorder, attention deficit disorder, or obsessive\r\n             compulsive disorder\r\n\r\n          -  History of head injury with loss of consciousness\r\n\r\n          -  Metallic surgical implants or traumatically implanted metallic foreign bodies\r\n\r\n          -  Inability to lie flat for about an hour\r\n\r\n          -  Discomfort being in small, enclosed spaces\r\n\r\n          -  Dementia (Montreal Cognitive Assessment score < 21)\r\n\r\n          -  Depression (Beck Depression Inventory-II score > 19)\r\n\r\n          -  Hoehn & Yahr stage > 3 (i.e., able to stand and walk, but not fully independent)\r\n\r\n          -  Focal neurological findings on exam that suggest cerebral pathology other than that\r\n             associated with parkinsonism\r\n\r\n          -  Motor symptoms that could potentially introduce too much motion artifact in the\r\n             imaging data (e.g., MDS-UPDRS resting tremor score > 1 in limbs, head/chin tremor, or\r\n             dyskinesia by history or exam).\r\n      ","sponsor":"Yale University","sponsor_type":"Other","conditions":"Parkinson Disease","interventions":[{"intervention_type":"Other","name":"Other: PD neurofeedback","description":"PD-neurofeedback subjects will practice motor imagery in the MRI scanner and receive neurofeedback on their performance. There will be a total of 10-12 neurofeedback sessions on two separate days. Subjects will continue practicing motor imagery at home every day throughout the study period for 4-6 weeks."},{"intervention_type":"Other","name":"Other: PD control","description":"PD-control subjects will practice visual imagery (e.g., of scenery, objects, etc., but not of movement) in the MRI scanner and will not receive neurofeedback on their performance. Subjects will continue practicing visual imagery at home every day throughout the study period for 4-6 weeks."}],"outcomes":[{"outcome_type":"primary","measure":"Change in right insula-dorsomedial frontal cortex functional connectivity strength.","time_frame":"4-6 weeks","description":"The functional connectivity strength between the subjects' right insula and dorsomedial frontal cortex will be measured at baseline and post-intervention as each group of subjects engages in their respective imagery tasks. Functional connectivity will be measured as the correlation value between the functional MRI signal time courses obtained from these two brain regions."},{"outcome_type":"primary","measure":"Change in resting-state functional connectivity of the right insula and dorsomedial frontal cortex.","time_frame":"4-6 weeks","description":"We will obtain resting-state functional MRI scans from the PD-neurofeedback and PD-control groups at baseline and post-intervention to examine the changes in intrinsic functional connectivity of the right insula and dorsomedial frontal cortex with each other and with the whole brain. Functional connectivity will be measured as the correlation value between the functional MRI signal time courses obtained from these two brain regions and every other brain region."},{"outcome_type":"primary","measure":"Change in motor impairment","time_frame":"4-6 weeks","description":"We will administer the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III (motor exam) at baseline and post-intervention to the PD-neurofeedback and PD-control groups to measure the change in motor impairment. The MDS-UPDRS part III is a subscale that provides an objective assessment of motor impairment. The scores range between 0-132. Higher scores indicate more severe impairment."},{"outcome_type":"primary","measure":"Change in motor function","time_frame":"4-6 weeks","description":"We will administer standard motor function tests (e.g., timed up and go, 5 times sit-to-stand, 50-ft walk, 360-degree turn) at baseline and post-intervention to the PD-neurofeedback and PD-control groups to measure the change in motor function. The performance score on these tests is the time to complete the motor tasks. Shorter time indicates better performance. We will z-transform and sum the time to completion (in seconds) on each motor task to compute a composite motor function score."}]}
{"nct_id":"NCT03563248","start_date":"2018-08-10","phase":"Phase 2","enrollment":160,"brief_title":"Losartan and Nivolumab in Combination With FOLFIRINOX and SBRT in Localized Pancreatic Cancer","official_title":"A Randomized Phase 2 Study of Losartan and Nivolumab in Combination With FOLFIRINOX and SBRT in Localized Pancreatic Cancer","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2025-12-31","last_update":"2021-01-20","description":"This research study is studying a combination of interventions as a possible treatment for pancreatic tumor. The interventions involved in this study are: - FOLFIRINOX which is made up of 4 different drugs: - 5-Fluorouracil (5-FU) - Oxaliplatin - Irinotecan - Leucovorin - Losartan - Nivolumab - Radiation Therapy - Surgery","other_id":"18-179","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically confirmed localized pancreatic adenocarcinoma; borderline/potentially\r\n             resectable or locally advanced.\r\n\r\n          -  Borderline resectable is defined by the NCCN as tumors with venous involvement of the\r\n             SMV/portal vein demonstrated tumor abutment with or without impingement and narrowing\r\n             of the lumen, either tumor thrombus or encasement but with suitable vessel proximal\r\n             and distal to the area of vessel involvement, allowing for safe resection or\r\n             reconstruction; gastroduodenal artery encasement up to the hepatic artery with either\r\n             short segment encasement or direct abutment of the hepatic artery, without extension\r\n             to the celiac axis; or tumor abutment of the SMA not to exceed greater than 180\r\n             degrees of the circumference of the vessel wall. Tumors involving retroperitoneal\r\n             structures that can be surgically removed (i.e. kidney), will also be included.\r\n\r\n          -  Localized is defined as no extrapancreatic disease, no evidence (on CT) of involvement\r\n             of the celiac axis or SMA, no evidence (CT or MRI) of occlusion of the SMV or SMPV\r\n             confluence, no evidence of gross peritoneal or distant metastases on staging\r\n             laparoscopy or laparotomy.\r\n\r\n          -  Locally advanced unresectable disease is defined by the NCCN as: Tumors of the head\r\n             that have greater than 180 degrees of SMA encasement or any celiac abutment,\r\n             unreconstructable SMV or portal occlusion, or aortic invasion or encasement. Tumors of\r\n             the body with SMA or celiac encasement of greater than 180 degrees, unreconstructable\r\n             SMV or portal occlusion, or aortic invasion. Tumors of the tail with SMA or celiac\r\n             encasement of greater than 180 degrees. Irrespective of location, all tumors with\r\n             evidence of nodal metastasis outside of the resection field are deemed unresectable.\r\n\r\n          -  Age > 18 years\r\n\r\n          -  ECOG performance status 0-1\r\n\r\n          -  Baseline Systolic Blood Pressure (SBP) > 100 mm Hg. This is based on the average of\r\n             two values - separate seated, resting measurements taken five minutes apart. BP does\r\n             not need to be checked in both arms unless a reading is below 110 mm Hg, in which case\r\n             the other arm can be checked as well. If BP is checked in both arms, the higher value\r\n             is deemed accurate for calculating the average.\r\n\r\n          -  Normal organ and marrow function as defined below:\r\n\r\n               -  absolute neutrophil count  1,500/mm3\r\n\r\n               -  platelets  100,000/mm3\r\n\r\n               -  total bilirubin  1.5 x institutional upper limit of normal if no biliary\r\n                  stenting has been done OR 2.0 x upper limit of normal if patient is s/p biliary\r\n                  stenting OR two down trending values\r\n\r\n               -  AST(SGOT)/ALT(SGPT)  2.5  institutional upper limit of normal\r\n\r\n               -  Potassium (not hemolyzed) < 5 mmol/L\r\n\r\n               -  creatinine  1.5 mg/ dL OR\r\n\r\n               -  creatinine clearance  30 mL/min (as estimated by Cockcroft Gault Equation)\r\n\r\n          -  (140 - age [yrs]) (body wt [kg]) -Creatinine clearance for males = ------------\r\n\r\n          -  (72) (serum creatinine [mg/dL])\r\n\r\n          -  Creatinine clearance for females = 0.85 x male value\r\n\r\n          -  Women of childbearing potential (WOCBP) must use appropriate method(s) of\r\n             contraception. WOCBP should use an adequate method to avoid pregnancy for 5 months\r\n             after the last dose of investigational drug.\r\n\r\n          -  Women of childbearing potential must have a negative serum or urine pregnancy test\r\n             (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the\r\n             start of nivolumab\r\n\r\n          -  Women must not be breastfeeding\r\n\r\n          -  Men who are sexually active with WOCBP must use any contraceptive method with a\r\n             failure rate of less than 1% per year. Men who are sexually active with WOCBP will be\r\n             instructed to adhere to contraception for a period of 7 months after the last dose of\r\n             investigational product. Women who are not of childbearing potential, ie, who are\r\n             postmenopausal or surgically sterile as well as azoospermic men do not require\r\n             contraception\r\n\r\n          -  Ability to understand and the willingness to sign a written informed consent document\r\n\r\n          -  If applicable, must be on a stable dose of dexamethasone 2 mg or less for 7 days prior\r\n             to initiation of treatment\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  NOTE: Patients enrolled to the randomized portion of the study (arms 1 thru 3) may not\r\n             be already treated on ACE or ARB therapy for hypertension or renal protection (with\r\n             diabetes) at the time of enrollment. If patients are receiving ACE or ARB therapy,\r\n             they may ONLY be considered for the exploratory arm, Arm 4.\r\n\r\n          -  Serious concomitant systemic disorders incompatible with the study (at the discretion\r\n             of the investigator), such as significant cardiac or pulmonary morbidity e.g.\r\n             congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias\r\n             not well controlled with medication) or myocardial infarction within the last 12\r\n             months, ongoing infection as manifested by fever.\r\n\r\n          -  Pregnant or lactating women. Women of childbearing potential with either a positive or\r\n             no pregnancy test (serum or urine) at baseline. (Postmenopausal women must have been\r\n             amenorrheic for at least 12 months to be considered of non-childbearing potential.)\r\n\r\n          -  Any prior chemotherapy, radiation therapy, immunotherapy, or biologic ('targeted')\r\n             therapy for treatment of the patient's pancreatic tumor\r\n\r\n          -  Treatment for other invasive carcinomas within the last five years who are at greater\r\n             than 5% risk of recurrence at time of eligibility screening. Carcinoma in-situ and\r\n             basal cell carcinoma/ squamous cell carcinoma of the skin are allowed.\r\n\r\n          -  Lack of physical integrity of the upper gastrointestinal tract or malabsorption\r\n             syndrome\r\n\r\n          -  Known, existing uncontrolled coagulopathy\r\n\r\n          -  Prior systemic fluoropyrimidine therapy within the past 10 years. Prior topical\r\n             fluoropyrimidine use is allowed. Prior unanticipated severe reaction to\r\n             fluoropyrimidine therapy, or known hypersensitivity to 5-fluorouracil or known DPD\r\n             deficiency.\r\n\r\n          -  Participation in any investigational drug study within 4 weeks preceding the start of\r\n             study treatment\r\n\r\n          -  History of uncontrolled seizures, central nervous system disorders or psychiatric\r\n             disability judged by the investigator to be clinically significant, precluding\r\n             informed consent, or interfering with compliance or oral drug intake.\r\n\r\n          -  Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment,\r\n             without complete recovery\r\n\r\n          -  Concomitant use of cimetidine, as it can decrease the clearance of 5-FU. Another\r\n             H2-blocker or proton pump inhibitor may be substituted before study entry\r\n\r\n          -  History of allergic reactions attributed to compounds of similar chemical or biologic\r\n             composition to 5-fluorouracil, irinotecan, oxaliplatin, or losartan\r\n\r\n          -  Other serious medical conditions that the investigator feels might compromise study\r\n             participation\r\n\r\n          -  An active, known or suspected autoimmune disease other than those listed below.\r\n             Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus,\r\n             residual hypothyroidism due to autoimmune condition only requiring hormone\r\n             replacement, psoriasis not requiring systemic treatment, or conditions not expected to\r\n             recur in the absence of an external trigger\r\n\r\n          -  A condition requiring systemic treatment with either corticosteroids (> 15 mg daily\r\n             prednisone equivalents) or other immunosuppressive medications within 14 days of study\r\n             drug administration. Inhaled or topical steroids and adrenal replacement doses > 15 mg\r\n             daily prednisone equivalents are permitted in the absence of active autoimmune\r\n             disease. Subjects are permitted to use topical, ocular, intra-articular, intranasal,\r\n             and inhalational corticosteroids (with minimal systemic absorption). Physiologic\r\n             replacement doses of systemic corticosteroids are permitted, even if > 10 mg/day\r\n             prednisone equivalents. A brief course of corticosteroids for prophylaxis (eg,\r\n             contrast dye allergy) or for treatment of non-autoimmune conditions (eg, delayed-type\r\n             hypersensitivity reaction caused by contact allergen) is permitted.\r\n\r\n          -  Known history of active TB (Bacillus Tuberculosis)\r\n\r\n          -  Known positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C\r\n             virus ribonucleic acid (HCV antibody) indicating acute or chronic infection\r\n\r\n          -  Known history of testing positive for human immunodeficiency virus (HIV) or known\r\n             acquired immunodeficiency syndrome (AIDS).\r\n\r\n          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active\r\n             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac\r\n             arrhythmia, or psychiatric illness/social situations that would limit compliance with\r\n             study requirements.\r\n\r\n          -  Known psychiatric or substance abuse disorders that would interfere with cooperation\r\n             with the requirements of the trial.\r\n\r\n          -  Is pregnant or breastfeeding, or expecting to conceive or father children within the\r\n             projected duration of the trial, starting with the pre-screening or screening visit\r\n             through 5 months for woman and 7 months for men, after the last dose of trial\r\n             treatment.\r\n\r\n          -  Known history of, or any evidence of active, non-infectious pneumonitis\r\n\r\n          -  Has received a live vaccine within 30 days of planned start of study therapy. Note:\r\n             Seasonal influenza vaccines for injection are generally inactivated flu vaccines and\r\n             are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live\r\n             attenuated vaccines, and are not allowed.\r\n\r\n          -  History of severe hypersensitivity reaction to any monoclonal antibody\r\n      ","sponsor":"Massachusetts General Hospital","sponsor_type":"Other","conditions":"Pancreatic Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: FOLFIRINOX","description":"FOLFIRINOX is a combination of 4 chemotherapy agents that may help shrink your tumor before surgery\r\n5-Fluorouracil (5-FU) - 400 mg/m2 on day one, followed by 1200 mg/m2 by continuous infusion for the subsequent 46-48 hours\r\nOxaliplatin - 85 mg/m2 by intravenous infusion over 120 minutes on day 1 of each 14 day cycle\r\nIrinotecan - administered at a starting dose of 180 mg/m2 by intravenous infusion over 90 minutes on day 1 of each 14 day cycle\r\nLeucovorin - Administered at a starting dose of 400 mg/m2 over 2 hours on day 1 of each 14 day cycle"},{"intervention_type":"Drug","name":"Drug: Losartan","description":"Losartan is a drug that is used to lower blood pressure"},{"intervention_type":"Drug","name":"Drug: Nivolumab","description":"Nivolumab is an antibody that may cause programmed cell death of cancer cells"},{"intervention_type":"Radiation","name":"Radiation: SBRT","description":"Radiation therapy is believed to increase the likelihood of response of immunotherapy"},{"intervention_type":"Procedure","name":"Procedure: Surgery","description":"definitive surgical resection"}],"outcomes":[{"outcome_type":"secondary","measure":"Progression-free survival","time_frame":"From randomization until the time of progression or death, up to approximately 6 years","description":"Progression-free survival is defined as the time from the date of randomization (or registration on Arm 4) to first objective documentation of progressive disease (distant or local) or death. Disease status is evaluated using RECIST (Response Evaluation Criteria in Solid Tumors). Disease progression is defined as having at least a 20% increase in the sum of the longest diameter (LD) of target lesion, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions."},{"outcome_type":"primary","measure":"Proportion of participants with R0 resection","time_frame":"Up to 8 months after baseline","description":"R0 resection is defined as microscopically negative margins determined by histopathologic assessment of the resection specimen. The R0 resection rate will be analyzed among all eligible patients, including those not resected due to early progression, death or off-study."},{"outcome_type":"secondary","measure":"Overall survival","time_frame":"From randomization until the time of death, up to approximately 6 years","description":"Overall Survival (OS) is defined as the time from randomization (or registration on Arm 4) to death due to any cause, or censored at date last known alive."},{"outcome_type":"secondary","measure":"Pathologic complete response","time_frame":"Up to 8 months after baseline","description":"The proportion of participants that achieved a pathologic complete response. Pathologic complete response is defined as the disappearance of all target lesions, as confirmed by a pathologist evaluating the tissue samples removed during surgery."},{"outcome_type":"secondary","measure":"Number of participants with treatment related serious adverse events","time_frame":"From the start of treatment until 30 days after the end of treatment, up to approximately 14 months","description":"Adverse events are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Adverse events are considered to be related to treatment if the Investigator deems them to be either possibly, probably, or definitely related to treatment."}]}
{"nct_id":"NCT03800667","start_date":"2018-08-08","phase":"Early Phase 1","enrollment":0,"brief_title":"Vitamin C for the Prevention of UTI in Women Who Undergo Elective GYN Surgeries","official_title":"Vitamin C for the Prevention of UTI in Women Who Undergo Elective GYN Surgeries: a Study Protocol for a Randomized Controlled Trial","primary_completion_date":"2019-07-12","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2019-07-12","last_update":"2019-07-15","description":"This open-label randomized trial aims at assessing the role of Vitamin C pills in the prevention of catheter-associated urinary tract infections in women undergoing elective gynecological surgeries.","other_id":"OGY.TB.09","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Non pregnant women at least 18 years of age visiting the Preadmission unit (PAU) or the\r\n        OBGYN floor (7N), presenting for elective GYN surgery at the American University of Beirut\r\n        Medical Center (AUBMC).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any women with the following:\r\n\r\n               1. Nephrolithiasis\r\n\r\n               2. Congenital anomaly or neurogenic bladder\r\n\r\n               3. Allergy to ascorbic acid\r\n\r\n               4. Who require therapeutic anticoagulant medicine during the 6 weeks after surgery\r\n\r\n               5. Surgery did involve a fistula repair or a vaginal mesh removal\r\n\r\n               6. Positive Urinalysis in the PAU\r\n\r\n               7. Recurrent UTI's\r\n\r\n               8. Diabetes\r\n\r\n               9. G6PD\r\n\r\n              10. Hemochromatosis\r\n\r\n              11. Renal disorders\r\n\r\n        Patients already taking Vitamin C supplementation will also be excluded from the study.\r\n      ","sponsor":"American University of Beirut Medical Center","sponsor_type":"Other","conditions":"Catheter-Associated Urinary Tract Infection, Ascorbic Acid","interventions":[{"intervention_type":"Drug","name":"Drug: Ascorbic Acid 1000 MG","description":"1000 mg ascorbic acid (Vitamin C) for 1 month post-op after an elective gynecological surgery."}],"outcomes":[{"outcome_type":"primary","measure":"Proportion of participants who experienced clinically diagnosed and treated UTI.","time_frame":"30 days","description":"Urinary tract infection is diagnosed by a positive urine culture."}]}
{"nct_id":"NCT03710681","start_date":"2018-08-02","phase":"Phase 1","enrollment":16,"brief_title":"A Safety Study of Multiple Subcutaneous (s.c.) Injections of SHR-1314 in Adults With Moderate-to-severe Plaque Psoriasis","official_title":"Safety, Tolerability and Pharmacokinetics Studies Following Multiple Subcutaneous Injections of SHR-1314 in Adults With Moderate-to-severe Plaque Psoriasis","primary_completion_date":"2019-04-21","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-07-30","last_update":"2018-10-18","description":"This is a multiple dose escalating and open labeled clinical trial to evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple subcutaneous (s.c.) injections of SHR-1314 in adults with moderate-to-severe plaque psoriasis. The primary objective of this study is to investigate the safety and tolerability of multiple doses of subcutaneous SHR-1314 in subjects with moderate-to-severe plaque psoriasis. Secondary objectives are to determine the pharmacokinetics (PK) and immunogenicity profile of SHR-1314 in subjects with moderate-to-severe plaque psoriasis.","other_id":"SHR-1314-103","allocation":"Non-Randomized","intervention_model":"Sequential Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Male or female at age between 18 and 65 years old at screening.\r\n\r\n          2. History of chronic plaque-type psoriasis for at least 6 months, with either documented\r\n             medical history of psoriasis for at least 6 months or confirmation of the diagnosis by\r\n             the Investigator at screening, if the subject was diagnosed by another physician.\r\n\r\n          3. At the time of randomization, moderate to severe plaque psoriasis, defined by:\r\n\r\n               -  PASI score of 12 or greater and\r\n\r\n               -  PGA score of 3 or greater and\r\n\r\n               -  BSA affected by plaque-type psoriasis of 10% or greater.\r\n\r\n          4. A subject is a candidate for systemic psoriasis therapy and/or phototherapy and/or\r\n             chemo phototherapy.\r\n\r\n          5. Body Mass Index (BMI) of 18 to 35 kg/m2 (inclusive) at screening.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and\r\n             guttate psoriasis) at screening.\r\n\r\n          2. Drug-induced psoriasis (i.e. new onset or current exacerbation from beta-blockers,\r\n             calcium channel inhibitors or lithium) at randomization.\r\n\r\n          3. Active systemic infections (other than common cold) during the two weeks before\r\n             randomization (e.g., hepatitis), or serious infections requiring hospitalization\r\n             and/or intravenous injection of antibiotic treatment within eight weeks prior to\r\n             randomization.\r\n\r\n          4. History of inflammatory bowel disease or have other ongoing active autoimmune\r\n             diseases.\r\n\r\n          5. At screening, history or symptoms of malignancy of any organ system, treated or\r\n             untreated, within the past 5 years, regardless of whether there is evidence of local\r\n             recurrence or metastases.\r\n\r\n          6. History of depression and/or suicidal ideation or any suicidal behavior based on\r\n             clinical assessment by the investigator.\r\n\r\n          7. Have a known allergy or hypersensitivity to any biologic therapy at screening that\r\n             would pose an unacceptable risk to the subject if participating in this study.\r\n\r\n          8. Are currently enrolled in, or discontinued from a clinical trial involving an IP\r\n             within the last 4 weeks or at least 5 half-lives of the last dosing prior to\r\n             randomization, whichever is longer; or concurrently enrolled (at randomization) in any\r\n             other trials.\r\n\r\n          9. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a\r\n             female after conception and until the termination of gestation, confirmed by a\r\n             positive human chorionic gonadotropin laboratory test at screening or Day 0.\r\n\r\n         10. Females of childbearing potential (defined as all females physiologically capable of\r\n             becoming pregnant) and males who are unwilling or unable to use highly effective\r\n             contraception during the study and 21 weeks after the last administration of IP\r\n             (anticipated 5 half-lives).\r\n\r\n         11. History of alcohol or illicit drug abuse within the year prior to screening.\r\n\r\n         12. Have any other condition that precludes the subject from following and completing the\r\n             protocol, in the opinion of the Investigator.\r\n      ","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","sponsor_type":"Industry","conditions":"Moderate-to-severe Plaque Psoriasis","interventions":[{"intervention_type":"Biological","name":"Biological: SHR-1314","description":"Pharmaceutical form: Injection solution. Route of administration: subcutaneous injection."}],"outcomes":[{"outcome_type":"primary","measure":"Incidence and severity of Treatment-Emergent Adverse Events [Safety and tolerability]","time_frame":"Baseline to 168 days after first dose administration","description":"Incidence and severity of adverse events, change from baseline in vital signs and 12-lead electrocardiogram."},{"outcome_type":"primary","measure":"Incidence of development of Anti-drug Antibodies (ADAs) [Safety and Tolerability]","time_frame":"Baseline to 168 days after first dose administration","description":"Incidence of development of Anti-drug Antibodies (ADAs) during the course of the study."},{"outcome_type":"secondary","measure":"Assessment of PK parameter","time_frame":"Baseline to 168 days after first dose administration","description":"time to maximum concentration (tmax)"},{"outcome_type":"secondary","measure":"Assessment of PK parameter","time_frame":"Baseline to 168 days after first dose administration","description":"maximum concentration (Cmax)"},{"outcome_type":"secondary","measure":"Assessment of PK parameter","time_frame":"Baseline to 168 days after first dose administration","description":"area under curve (AUC0-14days)"},{"outcome_type":"secondary","measure":"Assessment of development of Anti-drug Antibodies (ADAs)","time_frame":"Baseline to 168 days after first dose administration","description":"Incidence of development of Anti-drug Antibodies (ADAs)"}]}
{"nct_id":"NCT04929977","start_date":"2018-08-01","phase":"N/A","enrollment":20,"brief_title":"m-Health System for Tracking Kangaroo Mother Care and Temperature in Southern India","official_title":"Evaluation of a m-Health System for Tracking Kangaroo Mother Care and Temperature for Providing Feedback to Family Care Givers or Front-line Workers to Enhance Kangaroo Mother Care Adherence","primary_completion_date":"2019-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-12-31","last_update":"2021-07-01","description":"The product innovation is a wearable device that (combined with a smartphone and back-end analytics system) acts as a sensor, processor and actuator, and is therefore designed to identify critical parameters (Kangaroo Mother Care adherence and temperature of neonate on a 24/7 basis and temperature of mother during these episodes), make intelligent and early diagnosis of (persistent or impending) neonatal hypothermia, maternal/neonatal fever and non-adherence to Kangaroo Mother Care and then trigger audio or visual alerts (via the wearable or smart-mobile phone) for action by the care-giver or front-line healthcare worker to enhance Kangaroo Mother Care duration or referral to a health facility as needed.","other_id":"OPP1182699","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Device Feasibility","masking_description":"None (Open Label)","intervention_model_description":"Wearable device combined with a smart mobile phone and back-end analytics system that acts as a temperature and touch sensor and actuator will be evaluated.","sampling_method":"","gender":"All","maximum_age":49,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Stable LBW babies who are less than 2000 grams\r\n\r\n          -  Kangaroo care provider who could preferably be the mother or any other family member\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Extreme preterm infants (corrected gestational age less than 28 weeks)\r\n\r\n          -  Any family member who is unwilling to hold the infant in Kangaroo Mother Care position\r\n             with the wearable device or if presenting with any infection\r\n      ","sponsor":"St. John's Research Institute","sponsor_type":"Other","conditions":"Preterm Infant|Low Birth Weight Infant|Kangaroo Mother Care|Hypothermia, Newborn|Fever","interventions":[{"intervention_type":"Device","name":"Device: Wearable device with smart mobile phone","description":"The wearable device will act as a sensor designed to identify critical parameters such as Kangaroo Mother Care adherence and temperature of the infant 24/7 and of the mother-infant pairs during these sessions."}],"outcomes":[{"outcome_type":"primary","measure":"Evaluation of hypothermia episodes through the wearable device (remote bio-monitoring - RBM) in real world","time_frame":"5 months","description":"1. Number of hypothermia (less than 36.5 degree centigrade) episodes"},{"outcome_type":"primary","measure":"Evaluation of touch through the wearable device (remote bio-monitoring - RBM) in real world","time_frame":"5 months","description":"1. No Kangaroo Mother Care ( Skin to skin contact between mother and baby) for 6 hours (alerted through RBM device)"},{"outcome_type":"secondary","measure":"Development of entire computational hardware of the remote bio-monitoring device","time_frame":"8 months","description":"No of alert messages from the RBM to project staffs.\r\nNo of heat map views - total and within 24 hrs.\r\nNo of responses to failure of normal temperature range (36.5-37 degree centigrade/ Kangaroo Mother Care alerts)"}]}
{"nct_id":"NCT04342299","start_date":"2018-08-01","enrollment":45,"brief_title":"The Antidepressant Advisor (Study 3): fMRI Study to Predict Treatment Response in Patients With Depression","official_title":"The Antidepressant Advisor: A Decision Support System for UK Primary Care - a Feasibility Study: Study 3","primary_completion_date":"2021-11-30","study_type":"Observational","rec_status":"Active, not recruiting","completion_date":"2022-11-30","last_update":"2021-09-08","description":"This prospective observational study (ADeSS-Study3) investigates candidate biomarkers prospectively predicting response to antidepressant medications and prognosis in major depressive disorder (MDD). Currently, about half of MDD patients will not respond to the first course of selective serotonin reuptake inhibitors (SSRIs), while more than 40% will also not achieve remission after a second round of another SSRI. There are functional magnetic resonance imaging (fMRI) measures in several brain regions, showing clinical potential as predictors of response and non-response to SSRIs. The overall aim of the study is to identify the neural signatures prospectively predicting poor prognosis in MDD patients after receiving four months of treatment in UK primary care. Specifically, it looks to evaluate four fMRI measures: 1) self-blame-selective subgenual cortex and ventral striatum connectivity with the right anterior temporal lobe; 2) pregenual anterior cingulate cortex activity in response to implicit emotional facial expressions; 3) amygdala activation in response to implicit emotional facial expressions; and 4) subgenual cingulate seed-based resting state. In addition, a more specific objective of the study is to provide the proof-of-concept for using fMRI to prospectively predict which MDD patients will not benefit from SSRI antidepressant treatments in UK primary care. The long-term translational aim is to identify such patients and provide them with alternative treatments without delay by informing a decision support system with the information provided by these candidate biomarkers. This study is linked to the Antidepressant Advisor Trial (ADeSS-Study 1: NCT03628027), in which the feasibility is evaluated of a novel computerised decision support system for antidepressant prescribing in MDD patients in a UK primary care setting.","other_id":"ADeSS_S3","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Most participants will be recruited through GP practices, based in South London, taking\r\n        part in the Antidepressant Advisor Trial (Study 1: NCT03628027).\r\n\r\n        In addition, other participants will be recruited through online advertising. While it is\r\n        essential for the larger clinical trial to recruit participants directly linked to a GP\r\n        practice (to allow for comparison), this is not a requirement for this study.\r\n\r\n        Control participants (no personal or family history of MDD) are recruited by asking\r\n        enrolled participants to ask their partner or friend whether they would be interested.\r\n        Using this approach, control participants are likely to be from the same socio-economic and\r\n        educational backgrounds to the participants.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  age 18 years +\r\n\r\n          -  at least moderately severe major depressive syndrome on PHQ-9 (score 15 +)\r\n\r\n          -  no plans to change GP practice\r\n\r\n          -  able to complete self-report scales orally or in writing\r\n\r\n          -  no previous prescription of mirtazapine or vortioxetine\r\n\r\n          -  early treatment resistance as defined by 1) current or recent prescription (in the\r\n             last 2 months) of any of the following antidepressants: citalopram, fluoxetine,\r\n             sertraline, escitalopram, paroxetine, venlafaxine, or duloxetine AND 2) previous\r\n             prescription of at least one other antidepressant out of the same list.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  inability to consent to study\r\n\r\n          -  unstable medical condition\r\n\r\n          -  currently receiving specialist psychiatric treatment\r\n\r\n          -  high suicide risk (MINI suicidality screen)\r\n\r\n          -  past diagnosis of schizophrenia or schizo-affective disorder\r\n\r\n          -  current psychotic symptoms (3 clinical screening questions)\r\n\r\n          -  bipolar disorder\r\n\r\n          -  currently at risk of being violent\r\n\r\n          -  drug (modified PHQ) or alcohol abuse (PHQ) over last 6 months\r\n\r\n          -  suspected central neurological condition\r\n\r\n          -  pregnancy or insufficient contraception in women of childbearing age\r\n\r\n          -  breastfeeding or within 6 months of giving birth in women of childbearing age\r\n\r\n          -  both escitalopram and sertraline have already been prescribed\r\n\r\n          -  MRI contraindications\r\n      ","sponsor":"King's College London","sponsor_type":"Other","conditions":"Major Depressive Disorder","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Baseline functional connectivity of the right superior anterior temporal lobe (RSATL) during self- vs. other-blame","time_frame":"4 months","description":"Functional connectivity will be measured using an optimised and shortened version of the so-called moral sentiment task. Statistical Parametric Mapping 12 (SPM12) will be used to determine psychophysiological interactions between previously reported RSATL seed and previously identified clusters of connectivity in BA25 and putamen/claustrum. These two connectivity measures will be compared for self-blame vs. other-blame and entered as two predictor variables into a logistic regression model.\r\nThe logistic regression model will include responder/non-responder as a binary outcome variable. Response to treatment will be defined as a reduction of depressive symptom levels of at least 50%, as assessed by the self-rated QIDS-SR16 from baseline to last follow-up."},{"outcome_type":"secondary","measure":"Baseline functional connectivity of the subgenual cingulate cortex (SCC) during resting state fMRI","time_frame":"4 months","description":"Functional connectivity maps will be computed using the images for each participant by correlating average time course within the a priori subgenual frontal seed region with the time course in three a priori ROIs, as obtained from the Dunlop et al 2017 authors."},{"outcome_type":"secondary","measure":"Baseline pregenual anterior cingulate cortex (pgACC) activity in response to implicit facial emotions","time_frame":"4 months","description":"For this secondary outcome, the main ROI is the pgACC, as obtained from Godlewska et al 2018 authors.\r\nThe task contrast of interest is the relative activation of sad vs happy faces. A 2-level analysis will be used to test the degree to which the change in neural activity in this contrast predicts response to treatment.\r\nThe first level consists of sad vs happy contrast maps, calculated for each depressed subject. Second-level random effects analysis will assess whether this change in neural activity differs between responders and non-responders."},{"outcome_type":"secondary","measure":"Baseline amygdala activation in response to implicit facial emotions","time_frame":"4 months","description":"For this secondary outcome, the main ROI is the left and right amygdala, as defined by Automated Anatomical Labelling (AAL) atlas.\r\nSPM12 will be used to model the blood oxygen level-dependent (BOLD) effect for sad and happy blocks. In the first-level fixed-effect analysis, images will be derived for the contrast of sad vs neutral, and happy vs neutral. Individual contrast images will be normalised to standard space, which then will be used for second-level random effect analyses.\r\nEach participant's parameter estimates (beta weights) of amygdala activation will be extracted from the voxels that defined the cluster of significant activation. These represent an index of BOLD signal change for sad minus neutral, and happy minus neutral."}]}
{"nct_id":"NCT03609281","start_date":"2018-08-01","enrollment":900,"brief_title":"Cesarean Scar Characteristics After Scheduled and Emergency Cesarean Deliveries","official_title":"Cesarean Scar Characteristics After Scheduled and Emergency Cesarean Deliveries: A Single Center Study","primary_completion_date":"2019-03-31","study_type":"Observational [Patient Registry]","rec_status":"Completed","completion_date":"2019-03-31","last_update":"2019-04-23","description":"This study was designed to evaluate the scar characteristics following scheduled and emergency cesarean deliveries.","other_id":"Ayman CS Scar","observational_model":"Cohort","time_perspective":"Cross-Sectional","sampling_method":"Probability Sample","gender":"Female","minimum_age":20,"maximum_age":35,"population":"All patients will be selected according to inclusion and exclusion criteria.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Primipara delivered by cs\r\n\r\n          -  Multipara with last delivery by cs\r\n\r\n          -  Full term delivery >37 weeks\r\n\r\n          -  Double layer cesarean repair\r\n\r\n          -  Pfannenstiel incison\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Repeat cs\r\n\r\n          -  Any placental abnormalities\r\n\r\n          -  Preterm delivery\r\n\r\n          -  Single layer cesarean repair\r\n\r\n          -  Refusal to participate\r\n      ","sponsor":"Tanta University","sponsor_type":"Other","conditions":"Cesarean Scar Niche|Cesarean Wound; Dehiscence|Cesarean Section; Dehiscence","interventions":[{"intervention_type":"Radiation","name":"Radiation: Ultrasound assessement of uterine scar","description":"3D ultrasound assessment of scar characteristics"}],"outcomes":[{"outcome_type":"primary","measure":"Scar characteristics","time_frame":"6 months","description":"Site of scar in relation to internal os of cervix"},{"outcome_type":"primary","measure":"Scar length","time_frame":"6 months","description":"length of scar in mm"},{"outcome_type":"primary","measure":"thickness of scar","time_frame":"6 months","description":"Scar depth in mm"},{"outcome_type":"primary","measure":"Scar volume","time_frame":"6 months","description":"Length multiplied by width multiplied by depth"},{"outcome_type":"primary","measure":"Scar vascularity","time_frame":"6 month","description":"Doppler on scar to assess vascularity"},{"outcome_type":"secondary","measure":"Scar defect or niche","time_frame":"6 months","description":"Assessment of scar weakness or scar defect by ultrasound with measurement of depth, width and length of defects plus the residual myometrial tissue"}]}
{"nct_id":"NCT03936179","start_date":"2018-08-01","phase":"N/A","enrollment":50,"brief_title":"High Dose PET/CT-guided Intensity Modulated Radiotherapy and Concurrent Chemotherapy in Esophageal Cancer","official_title":"Phase II Trial of High Dose PET/CT-guided Radiation Therapy With Concurrent Weekly Carboplatin and Paclitaxel in Localregionally Advanced Esophageal Cancer","primary_completion_date":"2021-08-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-04-01","last_update":"2021-03-18","description":"To assess the efficacy and feasibility of high-dose intensity-modulated radiotherapy with concurrent weekly paclitaxel and cisplatin for patients with locaregionally esophageal cancer","other_id":"SGH201921","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients must have FDG-avid and histologically or cytologically proven esophageal\r\n             cancer.\r\n\r\n          -  Patients must be deemed unresectable disease or patient is not deemed operable due to\r\n             medical reasons.\r\n\r\n          -  Eastern Cooperative Oncology Group ECOG performance status 0 to 2 No prior radiation\r\n             to the thorax that would overlap with the current treatment field.\r\n\r\n          -  Patients with nodal involvement are eligible\r\n\r\n          -  Adequate bone marrow, renal and hepatic functions as assessed by the following:\r\n             Hemoglobin >/= 10.0 g/dl, Platelet count >/= 1 00,000/ mm^3,absolute granulocyte count\r\n             (AGC) 2  10^9 cells/L,bilirubin and Aspartate transaminase 1.5 upper limit of\r\n             normal (ULN), Creatinine <\/ =1 .5 times ULN.\r\n\r\n          -  A signed informed consent must be obtained prior to therapy.\r\n\r\n          -  No prior radiation to the thorax that would overlap with the current treatment field.\r\n\r\n        Induction chemotherapy is allowed.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  The presence of a fistula.\r\n\r\n          -  Prior radiotherapy that would overlap the radiation fields.\r\n\r\n          -  gastroesophageal junction cancer or the lower third esophageal cancer invading the\r\n             gastric wall.\r\n\r\n          -  Uncontrolled concurrent illness including, but not limited to: Chronic Obstructive\r\n             Pulmonary Disease(COPD) exacerbation or other respiratory illness, serious\r\n             uncontrolled infection, symptomatic congestive heart failure (CHF),unstable angina\r\n             pectoris, uncontrolled hypertension,or psychiatric illness/social situations that\r\n             would limit compliance with the study requirements.\r\n\r\n          -  Known hypersensitivity to paclitaxel.\r\n\r\n          -  Any other condition or circumstance that would, in the opinion of the Investigator,\r\n             make the patient unsuitable for participation in the study.\r\n\r\n          -  Acquired Immune Deficiency Syndrome.\r\n\r\n          -  Conditions precluding medical follow-up and protocol compliance\r\n      ","sponsor":"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine","sponsor_type":"Other","conditions":"Esophageal Cancer","interventions":[{"intervention_type":"Radiation","name":"Radiation: high dose radiation therapy with concurrent chemotherapy","description":"standard dose of 50 Gy concurrent weekly with paclitaxel (45 mg/m2) and carboplatin (area under curve 1.5 ), immediately followed by hyperfractionated radiotherapy boost of 36 Gy in 30 fractions of 1.2 Gy to residual metabolic disease as defined by PET/CT"}],"outcomes":[{"outcome_type":"primary","measure":"overall survival rate","time_frame":"one year","description":"survival time was measured from the date of study enrollment to the date of death or last follow-up"},{"outcome_type":"secondary","measure":"acute and late toxicities","time_frame":"1 year","description":"Acute toxicities were graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) version 4"}]}
{"nct_id":"NCT03664596","start_date":"2018-08-01","phase":"N/A","enrollment":80,"brief_title":"Therapeutic And Dietary Effects Of The Sublimated Mare's Milk Supplement In Patients With Non-Alcoholic Steatohepatitis","official_title":"Evaluation Of The Therapeutic And Dietary Properties Of The Sublimated Mare's Milk Supplement In Patients With Non-Alcoholic Steatohepatitis","primary_completion_date":"2020-09-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-12-01","last_update":"2021-02-05","description":"This study evaluates the dietary and therapeutic effect of supplement consisting of sublimated mare milk among patients with non-alcoholic steatohepatitis.","other_id":"UDP.NAS.01","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":16,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with a verified diagnosis of non-alcoholic steatohepatitis;\r\n\r\n          -  Aged 16 to 60 years;\r\n\r\n          -  Absence of an allergic reaction to dairy products;\r\n\r\n          -  Willingness to consent to participate in the study.\r\n\r\n          -  Consent to adhere to treatment\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Taking antibiotics, cytostatics and steroids during the last 3 months;\r\n\r\n          -  Taking alcohol hepatotoxic doses (no more than 30 g alcohol per day for men and not\r\n             more than 20 g for women);\r\n\r\n          -  History of oncological diseases;\r\n\r\n          -  Presence of diabetes mellitus, decompensated forms of diseases, intestinal dyspepsia,\r\n             hypertension (blood pressure 140/90 mm Hg and more at the time of the initial visit to\r\n             the doctor), tuberculosis;\r\n\r\n          -  A positive result of screening for antibodies to viral hepatitis B, C and D, as well\r\n             as HIV\r\n\r\n          -  Presence of concomitant diseases of the kidneys, liver, cardiovascular, respiratory\r\n             and other body systems, oncological, mental health and decompensated endocrine\r\n             diseases, tuberculosis, and HIV infection;\r\n\r\n          -  Pregnancy and/or lactation;\r\n\r\n          -  Patient involvement in other clinical trials within the last 3 months;\r\n\r\n          -  Refusal to participate in the study.\r\n      ","sponsor":"Medical Centre Hospital of the President's Affairs Administration, Republic of Kazakhstan","sponsor_type":"Other","conditions":"Non-alcoholic Steatohepatitis","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Sublimated mare's milk","description":"Supplement obtained through sublimation of mare milk, packed into one-dosage sachet (20g), and dissolved in a warm water (36 degrees of Celcius)."},{"intervention_type":"Drug","name":"Drug: Ursodeoxycholic Acid","description":"Ursodeoxycholic acid in the form of 250 mg capsule."}],"outcomes":[{"outcome_type":"primary","measure":"Change in liver function indicators","time_frame":"Baseline, Week 2, Week 4, Week 6, Week 8","description":"Blood samples will be taken to determine changes in bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase AST, gamma-glutamyl transpeptidase (GGTP), alkaline phosphatase,"},{"outcome_type":"primary","measure":"Change in degree of steatosis and fibrosis (fibroelastometry method).","time_frame":"Baseline, Week 8","description":"Degree of steatosis and fibrosis will evaluated via fibroelastometry method."},{"outcome_type":"primary","measure":"Change in degree of steatosis and fibrosis (ultrasound method)","time_frame":"Baseline, Week 8","description":"Ultrasound will be used for assessment of steatosis and fibrosis."},{"outcome_type":"secondary","measure":"Change in biochemical blood test results (cholesterol, glucose)","time_frame":"Baseline, Week 2, Week 4, Week 6, Week 8","description":"Proportion of those with deviations from normal range will be reported and compared across periods and groups."},{"outcome_type":"secondary","measure":"Change in weight.","time_frame":"Baseline, Week 2, Week 4, Week 6, Week 8","description":"Frequency of patients with decreased weight will be detected and compared across groups/periods."},{"outcome_type":"secondary","measure":"Detection of general clinical symptoms of non-alcoholic steatohepatitis.","time_frame":"Baseline, Week 2, Week 4, Week 6, Week 8","description":"Symptoms such as of malaise, abdominal discomfort, vague right upper quadrant abdominal pain will be identified in patients during physical examination."}]}
{"nct_id":"NCT03598920","start_date":"2018-08-01","enrollment":20,"brief_title":"Aspiration Therapy for Obese Adolescents","official_title":"Study of Safety and Efficacy Assessment of Aspiration Therapy for Morbidly Obese Adolescents","primary_completion_date":"2021-12-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2021-12-31","last_update":"2020-10-06","description":"Interventional studies devoted to adolescents are relatively rare in the world. This has several reasons. Treatment and research on obesity are centered on advanced forms of obesity in adults, bearing in mind that social and health problems make these patients cope with their condition. Studies on children tend to focus on epidemiology. On the other hand, effective long-term effective treatment is not just for young adults and adolescents. However, appropriate long-term weight reduction methods could help with chronic obesity at the onset of the disease. Here, the ideal scheme at the outset of the disease is to use less invasive endoscopic methods and then use invasive surgical methods at a later age. The benefit of this study will certainly be to find out the reality of the use of this endoscopic method in young obese individuals, that is, population groups where, according to the WHO and CDC (Centers for Disease Control and Prevention), there has been a rapid increase in the incidence of obesity especially during the last 20 years.","other_id":"FNO-IK-Aspiration","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":16,"maximum_age":21,"population":"Adolescents with malignant obesity (BMI> 40) in range BMI 30-50 kg/m2.","criteria":"\n        Inclusion Criteria:\r\n\r\n        - history of conservative obesity treatments selected according to criteria IFSO (BMI\r\n        greater than 40 or greater than 35 with comorbidities)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Diabetes Type I.\r\n\r\n          -  blood clotting disorder\r\n\r\n          -  using of Insulin\r\n\r\n          -  psychiatric disorders\r\n\r\n          -  monogenic obesity (Prader-Willi syndrome, mutation of MC4R).\r\n\r\n          -  thyroid disease\r\n\r\n          -  diseases of the digestive system associated with disorders of intestinal absorption\r\n\r\n          -  history of corticosteroid therapy in the past 12 months\r\n\r\n          -  history of bulimia and other eating disorders\r\n      ","sponsor":"University Hospital Ostrava","sponsor_type":"Other","conditions":"Obesity, Morbid","interventions":[{"intervention_type":"Device","name":"Device: AsspireAssist","description":"Endoscopic bariatric procedure using the AsspireAssist device"},{"intervention_type":"Other","name":"Other: Nutritional consulting","description":"Nutritional consulting provided by a specialized consultant."}],"outcomes":[{"outcome_type":"primary","measure":"Long-term weight reduction assessment in kgs","time_frame":"12 months","description":"Evaluation of the success of treatment in terms of long-term weight reduction (difference in body weight in kilograms at the beginning vs. the end of the observation period of 12 months)."},{"outcome_type":"primary","measure":"Long-term changes of nutritional status","time_frame":"12 months","description":"Analysis of the dynamics of changes in nutrition status in adolescents after endoscopic bariatric treatment of obesity (BMI> 30) will be performed. In the study, serum concentrations of the following parameters will be measured: vitamins A, D, E, K, B1, B6, B12, Folic acid and plasma proteins such as albumin, pre albumin, creatinine. The measurements will be performed before the planned intervention and then in intervals at 3, 6 and 12 months after the procedure. The results will be presented in mmol/L."},{"outcome_type":"secondary","measure":"Changes in serum levels of adipose tissue hormones","time_frame":"12 months","description":"Analysis of the dynamics of changes in serum levels of adipose tissue hormones (Leptin, Adiponectin) in adolescents after endoscopic bariatric treatment of obesity (BMI> 30) will be performed. Points of measurements: before the planned intervention and then in intervals of 3, 6 and 12 months after procedure."},{"outcome_type":"secondary","measure":"Changes in serum levels of lipids","time_frame":"12 months","description":"Analysis of the dynamics of changes in serum levels of lipids in adolescents after endoscopic bariatric treatment of obesity (BMI> 30) will be performed. In the study, serum concentrations of the following lipids will be measured: triacylglycerols, total cholesterol, high-density lipoprotein, low-density lipoprotein cholesterol, Apo D and Apo E, FGF 21, FGF19, FXR receptor, Omentin 1. The measurements will be performed before the planned intervention and then in intervals at 3, 6 and 12 months after the procedure. The results will be presented in mmol/L."},{"outcome_type":"secondary","measure":"Changes in serum levels GI hormones and saccharide metabolism","time_frame":"12 months","description":"Analysis of the dynamics of changes in serum levels of usual panel of GI hormones in adolescents after endoscopic bariatric treatment of malignant obesity (BMI> 35) will be performed. The following serum levels markers of bone resorption and formation will be assessed: fasting glycaemia, insulin and hemoglobin A1C, C-peptide, acylated ghrelin, GLP-1, GIP, PYY. The measurements will be performed before the planned intervention and then in intervals at 3, 6 and 12 months after the procedure. The results will be presented in mmol/L."},{"outcome_type":"secondary","measure":"IWQOL Questionnaire evaluation","time_frame":"12 months","description":"Evaluation of effects of endoscopic bariatric interventions on quality of life will be performed by using the IWQOL questionnaire. Improvement from baseline quality of life as measured by standardized IWQOL patient questionnaire (http://www.qualityoflifeconsulting.com/iwqol-lite.html) intended to measure the patient health status."},{"outcome_type":"secondary","measure":"SF-36 Questionnaire evaluation","time_frame":"12 months","description":"Evaluation of effects of different types of bariatric interventions on the quality of life will be performed using the SF-36 questionnaire. Improvement from baseline quality of life as measured by standardized SF-36 patient questionnaire intended to measure the patient health status."}]}
{"nct_id":"NCT03671382","start_date":"2018-07-31","phase":"N/A","enrollment":104,"brief_title":"Communication During Medical Consultations in Singapore -Pilot","official_title":"Training Oncologists and Empowering Patients in Affective Communication During Medical Consultations in Singapore (TEAMS) - A Pilot Study","primary_completion_date":"2019-02-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-02-01","last_update":"2019-02-08","description":"Despite advanced cancer patients and their caregivers frequently experiencing psychological distress and wanting to know about their prognosis, oncologists rarely respond with empathy and provide adequate information regarding patient prognosis. We aim to address the communication gap during consultations by developing an Oncologist E-Learning Communications Skills Training Program guiding physicians on how to recognize and respond to patient/caregiver distress and to disclose prognosis; and a Patient Prompt Sheet to encourage discussions of psychological distress and prognosis. We will assess the feasibility of delivering this two-component intervention program within a cancer center in Singapore through a 2-arm randomized controlled trial in which 8 oncologists will be randomly assigned to Control Arm (n=4) and Intervention Arm (n=4). Oncologists in the intervention arm will receive the E-Learning Program. Their patients will also receive the Patient Prompt Sheet before their consultation with oncologist. After completion of oncologist intervention we will audio-record and survey 3 patients with Stage IV cancer and their caregivers per oncologist before and after their consultations. If the study is shown to be feasible and acceptable, then its effectiveness will be assessed in a larger trial.","other_id":"LCPC-IN","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":21,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        The inclusion criteria for oncologists are\r\n\r\n          1. All consultants and senior residents/registrars in the Departments of Medical Oncology\r\n             at National Cancer Centre, Singapore\r\n\r\n          2. Able to allow audio-recording during consultation\r\n\r\n        The inclusion criteria for patients are\r\n\r\n          1. Age  21 years old\r\n\r\n          2. Patients who are consulting an oncologist who is participating in the study\r\n\r\n          3. Patients who are Singaporeans or Singapore Permanent Residents\r\n\r\n          4. Diagnosis of stage IV cancer (with metastasis to visceral organs)\r\n\r\n          5. Able to allow audio-recording during consultation\r\n\r\n        Exclusion Criteria:\r\n\r\n        The exclusion criteria for oncologists are\r\n\r\n        a. Rejecting audio-recording during consultation\r\n\r\n        The exclusion criteria for patients are\r\n\r\n          1. Age  21 years old\r\n\r\n          2. Patients who are not Singaporeans or Singapore Permanent Residents\r\n\r\n          3. Rejecting audio-recording during consultation\r\n\r\n          4. Patients with psychiatric or cognitive disorder.\r\n      ","sponsor":"Duke-NUS Graduate Medical School","sponsor_type":"Other","conditions":"Communication Research","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Communication Training Program and Patient Prompt Sheet","description":"The intervention being delivered is a two-component intervent. First component is the Oncologist Communication Skills Training Program. This is an e-learning module teaching oncologists to recognize and respond to patient/caregiver distress, provide information including prognosis and discuss goals of care. The second component is a patient prompt sheet which will be administered to three patients of intervention arm oncologists in the waiting area at least 30 minutes before their consultation. The sheet includes structured questions for patients to ask the oncologist about diagnosis and prognosis and will prompt patients to label and express their emotions in a direct manner."}],"outcomes":[{"outcome_type":"primary","measure":"Assess feasibility and acceptability of intervention","time_frame":"up to 3 months","description":"Measured by proportion of intervention arm oncologists completing their intervention"},{"outcome_type":"secondary","measure":"Assess increase in number of empathic statements by oncologists","time_frame":"within 5 months","description":"Measured by coding audio-recorded consultations post-intervention"},{"outcome_type":"secondary","measure":"Assess increase in number of questions related to their prognosis asked by patients","time_frame":"within 5 months","description":"Measured by coding audio-recorded consultations post-intervention"}]}
{"nct_id":"NCT03229018","start_date":"2018-07-31","phase":"N/A","enrollment":9,"brief_title":"Effect of Different Voxel Sizes on Accuracy of CBCT Linear Measurements: Preclinical Study","official_title":"Effect of Different Voxel Sizes on Accuracy of 2D and 3D Mandibular Linear Measurements Using CRANEX 3D Cone Beam Computed Tomography Machine: Preclinical Study","primary_completion_date":"2018-09-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2018-09-30","last_update":"2018-01-25","description":"study target is assessment of the accuracy of linear measurement obtained from CBCT images on 3D volumetric rendering and multiplanar slices with different voxel sizes","other_id":"1611","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Selection of the human dry mandibles will be independent of age, gender and ethnicity.\r\n\r\n          -  They should be intact, free from any bone defects, fractures, pathology.\r\n\r\n          -  Dentate state of the mandibles is not an element in selection criteria; either\r\n             dentulous or edentulous mandibles are acceptable\r\n\r\n        Exclusion Criteria:\r\n\r\n        -\r\n      ","sponsor":"Cairo University","sponsor_type":"Other","conditions":"Cone-Beam Computed Tomography","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Voxel size","description":"200 m and 300 m Voxel Sizes"}],"outcomes":[{"outcome_type":"primary","measure":"Diagnostic accuracy of linear measurement","time_frame":"1 year","description":"Assessment of the accuracy of linear measurement obtained from CBCT images on 3D volumetric rendering and multiplanar slices with different voxel sizes"}]}
{"nct_id":"NCT04048837","start_date":"2018-07-30","enrollment":200,"brief_title":"Prospective Study for the Evaluation of Dengue Prognostic Biomarkers in Singapore","official_title":"Prospective Study for the Evaluation of Dengue Prognostic Biomarkers in Singapore","primary_completion_date":"2019-07-01","study_type":"Observational","rec_status":"Completed","completion_date":"2019-07-01","last_update":"2019-09-13","description":"World Health Organisation (WHO) has identified Dengue as the fastest spreading mosquito-borne disease in the world. This study follows on from the National Medical Research Council STOP Dengue Translational and Clinical Research flagship grant. Differential serum concentrations of alpha2-macroglobulin (A2M), chymase (CMA1) and vascular endothelial growth factor A (VEGFA) were discovered to accurately identify dengue patients who will develop severe disease from those who will not, prior to the development of severe complications. By identifying patients at risk of developing severe disease in advance, these patients can be monitored more closely to provide more timely fluid interventions, and hopefully further reduce fatality rate. At the same time, more patients who are not at risk can be managed as outpatients to further minimize unnecessary hospitalization costs and wastage of healthcare resources. After discovery of the Dengue prognostic biomarkers, a multivariate logistic regression predictive model was built from a small retrospective derivative cohort (50 subjects), followed by validation using a small prospective validation cohort (50 subjects). The model had a receiver operating characteristic (ROC) curve AUC (area under the curve) of 0.944, and a sensitivity and specificity of 90% and 91% during validation, respectively. The premise of this study is to validate our observations in a larger prospective cohort (200 subjects). At the same time, we would like to better understand the characteristics of the Dengue prognostic biomarkers, especially whether there are situations in which the biomarkers cannot predict Dengue Haemorrhagic Fever (DHF)/ Dengue Shock Syndrome (DSS) and/or Severe Dengue (SD) and how the biomarkers can further improve the cost-effectiveness of the clinical management of Dengue patients.","other_id":"PrognosDen","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":21,"maximum_age":100,"population":"Participants will be recruited from patients presenting themselves to the emergency\r\n        departments, outpatient clinic or inpatient wards of the participating sites, and who are\r\n        diagnosed by laboratory tests to be infected with Dengue. Delegated research staff will\r\n        screen laboratory-confirmed dengue patients with inclusion/exclusion criteria. Each\r\n        participant will be given an information sheet and informed consent will obtained from\r\n        him/her before any study procedures.","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Confirmed Dengue i.e. laboratory confirmation of acute Dengue for this current disease\r\n             episode by either (i) Positive polymerase chain reaction (PCR) for viral ribonucleic\r\n             acid (RNA), or (ii) Positive NS1 antigen test with a compatible clinical syndrome\r\n\r\n          2. At least 21 years of age based on his/her birthday, and\r\n\r\n          3. Willing and able to give informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Already classified as having Dengue Haemorrhagic Fever or Dengue Shock Syndrome (WHO\r\n             1997 classification) or severe Dengue (WHO 2009 classification) when they first\r\n             present themselves to the hospital.\r\n\r\n          2. Assessed by Investigators to be unlikely to comply with trial procedures.\r\n\r\n          3. Have known or suspected congenital or acquired immunodeficiency, immunosuppressive\r\n             therapy such as anti-cancer chemotherapy or radiation therapy within the past 6 months\r\n             or long term corticosteroid therapy.\r\n\r\n          4. Have received blood or blood-derived products in the past three months that might\r\n             interfere with the assessment of the biomarker responses.\r\n\r\n          5. Have participated in another clinical trial investigating a vaccine or drug in the\r\n             four weeks preceding the study.\r\n\r\n          6. Have received any vaccine in the four weeks preceding the study.\r\n\r\n          7. Are deprived of freedom by an administrative or court order or in an emergency setting\r\n             or hospitalized without his/her consent.\r\n      ","sponsor":"National University Hospital, Singapore","sponsor_type":"Other","conditions":"Dengue Hemorrhagic Fever|Dengue Shock Syndrome|Severe Dengue","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Concentration of serum A2M, CMA1 and VEGFA will be use to predict whether a dengue patient will develop severe disease as defined by WHO 1997 and WHO 2009 classifications.","time_frame":"7 days","description":"Blood will be drawn for measurements of serum concentrations of biomarkers via quantitative enzyme-linked immunosorbent assays (ELISA)."},{"outcome_type":"secondary","measure":"Number of participants develop Dengue Haemorrhagic fever (DHF) within study periods","time_frame":"7 days","description":"Patient symptoms will be accessed using WHO 1997 classification for DHF."},{"outcome_type":"secondary","measure":"Number of participants develop Dengue Shock Syndrome (DSS) within study periods","time_frame":"7 days","description":"Patient symptoms will be accessed using WHO 1997 classification for DSS"},{"outcome_type":"secondary","measure":"Number of participants develop Severe Dengue within study periods","time_frame":"7 days","description":"Patient symptoms will be accessed using WHO 2009 classification for severe dengue)"},{"outcome_type":"secondary","measure":"Cost of dengue treatments for adoption of such a dengue prognostic technology in hospital","time_frame":"7 days","description":"Hospital bills from and outpatient care will be collected to calculate the cost of dengue treatment."}]}
{"nct_id":"NCT03524235","start_date":"2018-07-18","phase":"Phase 1","enrollment":30,"brief_title":"Haploidentical Stem Cell Transplant With Prophylactic Natural Killer DLI for Lymphoma, Multiple Myeloma, and CLL","official_title":"IIT2017-03-Merin-HaploBFR: Bendamustine, Fludarabine, And Rituximab Conditioning For Haploidentical Stem Cell Transplantation With CD56-Enriched Donor Cell Infusion For Relapsed/Refractory Lymphoma, Multiple Myeloma, and CLL","primary_completion_date":"2022-05-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2024-05-31","last_update":"2021-09-21","description":"This study seeks to examine the investigational use of the conditioning regimen (bendamustine, fludarabine, and rituximab) prior to haploidentical peripheral blood allogeneic stem cell transplantation with Post-Transplant Cyclophosphamide. The study will also test the investigational use of CD56-enriched Donor Lymphocyte Infusion to see if this treatment is safe, and whether or not it will help patients achieve better outcomes post-transplant, including reduced risk of Graft-Versus-Host Disease (GVHD), and preventing disease relapse.","other_id":"IIT2017-03-Merin-HaploBFR","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        General Inclusion Criteria (For Treatment Groups)\r\n\r\n          -  Patient age 18 - 75 years\r\n\r\n          -  ECOG 0 - 2\r\n\r\n          -  HIV-positive patients are allowed if these criteria are met:\r\n\r\n               1. No history of opportunistic infections\r\n\r\n               2. CD4+ cell count greater or equal to 250 cells/mm3\r\n\r\n               3. No history of non-malignancy AIDS-defining conditions other than historical low\r\n                  CD4+ cell counts\r\n\r\n               4. Patient is on antiretroviral therapy with undetectable viral load. There must be\r\n                  minimal interactions of the antiviral therapy with the experimental treatment\r\n                  (antiretroviral such as ritonavir is potent CYP3A4 inhibitor and p-gp inducer may\r\n                  interact with tacrolimus resulted in increased serum concentration of\r\n                  tacrolimus).\r\n\r\n          -  Patients must have a related donor or who is at minimum HLA haploidentical. The donor\r\n             and recipient must be identical at least one allele of each of the following genetic\r\n             loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1. A minimum match of 5/10 is\r\n             therefore required, and will be considered sufficient evidence that the donor and\r\n             recipient share one HLA haplotype. An unrelated donor search is not required.\r\n             (Patients with a readily-available, suitable, fully-matched sibling donor less than\r\n             age 55 are not eligible for this trial, these patients should proceed to transplant\r\n             using the matched related donor as standard-of-care).\r\n\r\n        Criteria for Donor Eligibility\r\n\r\n          -  Age greater than 12 years\r\n\r\n          -  Donors must meet the selection criteria as defined by the Foundation for the\r\n             Accreditation of Hematopoietic Cell Therapy (FACT).\r\n\r\n          -  In the event that two or more eligible donors are identified, the following order of\r\n             priority will be used to determine the preferred donor:\r\n\r\n               -  Medically and psychologically fit and willing to donate\r\n\r\n               -  For CMV seronegative recipients, a CMV seronegative donor\r\n\r\n               -  Red blood-cell compatibility\r\n\r\n                    -  RBC cross-match compatible\r\n\r\n                    -  Minor ABO incompatibility\r\n\r\n                    -  Major ABO incompatibility\r\n\r\n          -  If more than one preferred donor is identified and there is no medical, HLA- or KIR\r\n             ligand reason to prefer one of them, then the following guidelines are recommended:\r\n\r\n        If the patient is male, choose a male donor:\r\n\r\n          -  Choose the youngest preferred donor\r\n\r\n          -  If the patient and family express a strong preference for a particular donor, use that\r\n             one.\r\n\r\n        Inclusion Criteria (Lymphoma)\r\n\r\n          -  Diagnosis of resistant or relapsed CLL, Non-Hodgkin Lymphoma, Hodgkin Lymphoma, T-cell\r\n             lymphoma, NK or NK/T Lymphoma.\r\n\r\n          -  Meets one of the following criteria:\r\n\r\n               -  relapsed after auto-transplant, or\r\n\r\n               -  failed to mobilize autologous stem cells, or\r\n\r\n               -  for whom allogeneic stem cell transplant is deemed appropriate given disease risk\r\n                  factors that make cure with autologous transplant seem unlikely, such as history\r\n                  of chemotherapy refractoriness, high risk disease\r\n                  features/mutations/translocations (e.g., Double Hit / Double Expressor DLBCL),\r\n                  short remission after prior chemotherapy, or histologic transformation (see\r\n                  below).\r\n\r\n          -  For Patients with Aggressive Mantle Cell and Diffuse Large B Cell Lymphoma who have\r\n             not had a prior autologous transplant:\r\n\r\n               -  Must have received at least 2 lines of prior therapy, and\r\n\r\n               -  Have been exposed to anthracycline, and\r\n\r\n               -  High and High-Intermediate aaIPI score (2 or 3 factors), and\r\n\r\n               -  Have relapsed within one year of primary therapy\r\n\r\n          -  For diagnosis of other aggressive lymphoma (e.g. NK/T Lymphoma, T Cell\r\n\r\n        Lymphoma, etc.):\r\n\r\n          -  Must have received at least 2 lines of prior therapy, and\r\n\r\n          -  Relapsed within 12 months of most recent therapy\r\n\r\n               -  For low-grade lymphomas / CLL:\r\n\r\n               -  Standard risk patients (absence of del(17p), absence of del(11q), no TP53\r\n                  mutation and absence of complex karyotype) must have progressed on BCR inhibitor,\r\n                  or undergone histologic transformation, to be eligible.\r\n\r\n               -  Patients with high risk disease (del(17p) or TP53 mutations and/or complex\r\n                  phenotype) who relapse after frontline therapy, demonstrate refractory disease to\r\n                  second line therapy (not BCR inhibitors), but show an objective response to BCR\r\n                  inhibitors are eligible to be taken off BCR inhibitors in order to proceed to\r\n                  alloHSCT on trial. Patients with high risk disease who relapse after frontline\r\n                  therapy, demonstrate refractory disease to second line therapy including BCR\r\n                  inhibitors (not BCL-2 inhibitors), but show an objective response to BCL-2\r\n                  inhibitors (venetoclax) are eligible to be taken off BCL-2 inhibitors in order to\r\n                  proceed to alloHSCT on trial.\r\n\r\n               -  For aggressive lymphomas, partial or complete remission (PR or CR) is required\r\n                  prior to alloHSCT.\r\n\r\n               -  Regarding CD20 expression: Patients with B cell malignancies that were CD20+ at\r\n                  any level at the time of relapse diagnosis (including partial / dim staining on\r\n                  IHC or partial / low level expression by flow cytometry) will receive rituximab\r\n                  as part of allogeneic transplant conditioning, if indicated. Patients with\r\n                  primary-refractory disease who were CD20+ at any level at the time of diagnosis\r\n                  will likewise receive rituximab, if indicated. Patients with histologies that\r\n                  were CD20- will not receive rituximab (T cell lymphoma, NK/T lymphoma, etc.).\r\n                  Fresh tissue / repeat biopsy is not required; the most recent biopsy will be\r\n                  reviewed to assess CD20 status.\r\n\r\n        Inclusion Criteria (Multiple Myeloma)\r\n\r\n        - Patient age 18 - 75 years with:\r\n\r\n          -  Early relapse (less than 24 months) after primary therapy that included an autologous\r\n             HSCT, or\r\n\r\n          -  High risk multiple myeloma defined as t(4;14), del(17p), -13, t(14;16), amp (1q21),\r\n             chromosome 8q24.1/c-MYC abnormality, or LDH > ULN at diagnosis, provided patients\r\n             respond favorably to salvage therapy before enrollment for alloHSCT on trial and\r\n             patient is age < 55, or\r\n\r\n          -  Patients failing to mobilize peripheral blood stem cells for autologous\r\n             transplantation, or\r\n\r\n          -  Extramedullary disease at diagnosis or relapse, or\r\n\r\n          -  Plasma-cell leukemia with chemosensitive disease\r\n\r\n        Inclusion Criteria - Control Patients (specimen collection, only)\r\n\r\n          -  Age 18-75 years\r\n\r\n          -  Undergoing standard-of-care reduced-intensity peripheral blood allogeneic stem cell\r\n             transplantation (any indication, donor source, conditioning regimen) using PTCy GVHD\r\n             prophylaxis.\r\n\r\n          -  Willing to provide longitudinal blood samples per Control Specimen Collection Calendar\r\n             for correlative studies (for comparison to specimens from patients treated on the\r\n             trial).\r\n\r\n          -  Agrees to let study personnel collect excess bone marrow aspirate whenever a bone\r\n             marrow biopsy is performed for clinical purposes, and use for research.\r\n\r\n        Exclusion Criteria\r\n\r\n          -  Patient has a readily-available, suitable, fully-matched sibling donor (MRD) less than\r\n             age 55. 'Suitable' means no high-titre donor-specific antibodies present, and negative\r\n             IDM testing with no contraindications.\r\n\r\n          -  Patient has a clinically-significant donor-specific antibody for the selected donor\r\n             (DSA clearance is not allowed).\r\n\r\n          -  Poor cardiac function: left ventricular ejection fraction <45% as determined by MUGA\r\n             or ECHO.\r\n\r\n          -  Symptomatic pulmonary disease. Poor pulmonary function: FEV1, FVC, and DLCO <50%\r\n             predicted (corrected for hemoglobin) for patients who have not received thoracic or\r\n             mantle irradiation. For patients who have received thoracic or mantle irradiation,\r\n             FEV1 and FVC <70% predicted or DLCO < 50 of predicted.\r\n\r\n          -  Poor liver function: bilirubin >2 mg/dl (not due to hemolysis, Gilbert's or primary\r\n             malignancy). ALT or AST > 5 x laboratory upper normal limits.\r\n\r\n          -  Poor renal function: Creatinine >2.0mg/dl or creatinine clearance (calculated\r\n             creatinine clearance is permitted) < 60 mL/min based on Traditional Cockcroft-Gault\r\n             formula\r\n\r\n          -  Women of childbearing potential who currently are pregnant (-HCG+) or who are not\r\n             practicing adequate contraception.\r\n\r\n          -  Uncontrolled viral, bacterial, or fungal infections. Patients with symptoms consistent\r\n             with RSV, influenza A, B, or parainfluenza at the time of enrollment will be assayed\r\n             for the above viruses and if positive are not eligible for the trial until they are no\r\n             longer symptomatic (patients may have continued assay positivity for a period of time\r\n             post resolution of symptoms secondary to the nature of the assay).\r\n\r\n          -  Uncontrolled CNS involvement by malignancy (patients with prior history of CNS disease\r\n             controlled with intrathecal chemotherapy or prior systemic therapy are allowed).\r\n\r\n          -  Patients who have any debilitating medical or psychiatric illness which would preclude\r\n             their giving informed consent or their receiving optimal treatment and follow-up.\r\n\r\n        Exclusion Criteria - Control Patients (specimen collection, only)\r\n\r\n          -  Undergoing myeloablative alloHSCT.\r\n\r\n          -  Non-PTCy GVHD prophylaxis.\r\n\r\n          -  Non-PBSC transplant (bone marrow stem cell source).\r\n\r\n          -  Not willing to give longitudinal blood specimens for research use or not willing to\r\n             allow access to medical records for non-clinical purposes.\r\n      ","sponsor":"Noah Merin","sponsor_type":"Other","conditions":"CLL|Multiple Myeloma|Hodgkin Lymphoma|Lymphoma|Chronic Lymphocytic Leukemia","interventions":[{"intervention_type":"Radiation","name":"Radiation: Total Body Irradiation","description":"Pre-Transplantation Total Body Irradiation"},{"intervention_type":"Procedure","name":"Procedure: Haploidentical Stem Cell Transplantation","description":"Haploidentical Stem Cell Transplantation"},{"intervention_type":"Biological","name":"Biological: CD56-Enriched Donor Lymphocyte Infusion","description":"CD56-Enriched Donor Lymphocyte Infusion"},{"intervention_type":"Drug","name":"Drug: Bendamustine","description":"Pre-Transplantation Bendamustine"},{"intervention_type":"Drug","name":"Drug: Fludarabine","description":"Pre-Transplantation Fludarabine"},{"intervention_type":"Drug","name":"Drug: Rituximab","description":"Pre-Transplantation Rituximab (Rituximab for lymphoma diagnosis only)"}],"outcomes":[{"outcome_type":"primary","measure":"Rate of Survival at 30 days post -transplantation","time_frame":"30 Days","description":"Proportion of patients undergoing BFR-TBI conditioning + haploidentical alloHSCT alive at 30 days post-transplantation."},{"outcome_type":"secondary","measure":"Rate of neutrophil engraftment at 30 days","time_frame":"30 days","description":"Proportion of patients undergoing BFR-TBI conditioning + haploidentical alloHSCT with neutrophil engraftment at 30 days post-transplantation.\r\n-Neutrophil engraftment is defined as ANC recovery to >500/uL."},{"outcome_type":"secondary","measure":"Rate of platelet recovery at 100 days post-transplantation","time_frame":"100 days","description":"Proportion of patients with platelets > 20/uL with no platelet transfusions within the prior 7 days at day 100 post-transplantation."},{"outcome_type":"secondary","measure":"Rate of severe chronic GVHD at 365 days post-transplantation","time_frame":"365 days","description":"Proportion of patients with severe chronic GVHD at day 365 post-transplantation.\r\n-Severe chronic GVHD is defined by NIH Consensus Criteria for GVHD severity"}]}
{"nct_id":"NCT03546907","start_date":"2018-07-16","phase":"Phase 2","enrollment":343,"brief_title":"Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of SAR440340 (Anti-IL-33 mAb) in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)","official_title":"A Randomized, Double-blind, Placebo-controlled, Parallel-group, Proof-of-Concept (PoC) Study to Assess the Efficacy, Safety and Tolerability of SAR440340, in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)","primary_completion_date":"2019-10-03","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-02-19","last_update":"2020-10-12","description":"Primary Objective: To investigate effects of SAR440340 (anti-interleukin-33 [IL-33] monoclonal antibody [mAb]) compared with placebo, on the annualized rate of moderate-to-severe acute exacerbations of COPD (AECOPD) over up to 52 weeks of treatment. - Moderate exacerbations are recorded by the Investigator and defined as AECOPD that require either systemic corticosteroids (such as intramuscular, intravenous or oral) and/or antibiotics. - Severe exacerbations are recorded by the Investigator and defined as AECOPD requiring hospitalization, emergency medical care visit or resulting in death. Secondary Objectives: To investigate effects of SAR440340 compared with placebo, on improving respiratory function, as assessed by pre-bronchodilator forced exploratory volume in 1 second (FEV1). To evaluate effects of SAR440340 compared with placebo, on Post-bronchodilator FEV1. To evaluate effects of SAR440340 compared with placebo, on duration from baseline to first moderate or severe AECOPD event. To evaluate effects of SAR440340 compared with placebo, on safety and tolerability.","other_id":"ACT15104","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":40,"maximum_age":75,"population":"","criteria":"\n        Inclusion criteria :\r\n\r\n          -  Participants with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) for at\r\n             least 1 year (based on Global Initiative for Chronic Obstructive Lung Disease [GOLD]\r\n             definition.\r\n\r\n          -  Participants with moderate-to-severe COPD (post-bronchodilator Forced Expiratory\r\n             Volume in 1 Second [FEV1]/forced vital capacity [FVC] <70% and post-bronchodilator\r\n             FEV1 % predicted <80%, but 30%).\r\n\r\n          -  Participants with COPD Assessment Test (CAT) score 10 at Screening\r\n\r\n          -  Participants with reported history of signs and symptoms of chronic bronchitis\r\n             (chronic productive cough for 3 months in the year up to screening in a patient in\r\n             whom other causes of chronic cough [e.g., gastroesophageal reflux, chronic\r\n             rhinosinusitis, bronchiectasis] have been excluded).\r\n\r\n          -  Participants with a documented history (eg. medical record verification) of 2\r\n             moderate exacerbations or 1 severe exacerbation within the year prior to screening. A\r\n             moderate exacerbation is defined as an acute exacerbation of COPD (AECOPD) requiring\r\n             systemic corticosteroids (oral, intravenous, or intramuscular) and/or treatment with\r\n             antibiotics (however, use of antibiotics alone does not qualify as a \"moderate\r\n             exacerbation\" unless documentation is available that use of antibiotics was necessary\r\n             for treatment of worsening symptoms of COPD). A severe exacerbation is defined as an\r\n             AECOPD that required a hospitalization.\r\n\r\n          -  Participants with Standard of Care background therapy, for 3 months and at a stable\r\n             dose for at least 1 month, including either:\r\n\r\n          -  Double therapy: Long acting beta agonist (LABA) + Long acting muscarinic agonist\r\n             (LAMA) or inhaled corticosteroid (ICS) + LABA or ICS + LAMA.\r\n\r\n        or\r\n\r\n          -  Triple therapy: LABA + LAMA +ICS.\r\n\r\n          -  Current or former smokers with a smoking history of 10 packs/year.\r\n\r\n        Exclusion criteria:\r\n\r\n          -  Concomitant severe diseases or diseases for which the use of Inhaled Corticosteroids\r\n             (ICS) (e.g., active pulmonary tuberculosis, etc.) or Long Acting Beta Agonists (LABA)\r\n             are contraindicated (e.g., diagnosis of a history of significant cardiovascular\r\n             diseases, insulin-dependent diabetes mellitus, hyperthyroidism, thyrotoxicosis,\r\n             pheochromocytoma, hypokalemia).\r\n\r\n          -  Use of injectable glucocorticosteroids or oral systemic glucocorticosteroids within\r\n             previous 1 month or more than 4 courses of IV glucocorticosteroids within the previous\r\n             6 months\r\n\r\n          -  Participants with Bronchial thermoplasty procedure (up to 3 years prior to Visit 1)\r\n\r\n          -  A current diagnosis of asthma according to the Global Initiative for Asthma (GINA)\r\n             guidelines.\r\n\r\n          -  Significant pulmonary disease other than COPD (e.g., lung fibrosis, sarcoidosis,\r\n             interstitial lung disease, pulmonary hypertension, bronchiectasis, eosinophilic\r\n             granulomatosis with polyangiitis, significant sleep apnea on Bilevel Positive Airway\r\n             Pressure, etc) or another diagnosed pulmonary or systemic disease associated with\r\n             elevated peripheral eosinophil counts.\r\n\r\n          -  Diagnosis of -1 anti-trypsin deficiency.\r\n\r\n          -  Advanced COPD with need for chronic (>15 hours/day) oxygen support.\r\n\r\n          -  Participant with a moderate or severe Acute Exacerbation of COPD event within previous\r\n             4 weeks\r\n\r\n          -  A participant who has experienced an upper or lower respiratory tract infection within\r\n             previous 4 weeks\r\n\r\n          -  Prior history of or planned pneumonectomy or lung volume reduction surgery.\r\n\r\n        The above information is not intended to contain all considerations relevant to a patient's\r\n        potential participation in a clinical trial.\r\n      ","sponsor":"Sanofi","sponsor_type":"Industry","conditions":"Chronic Obstructive Pulmonary Disease","interventions":[{"intervention_type":"Drug","name":"Drug: Itepekimab (SAR440340)","description":"Pharmaceutical form: Solution for injection Route of administration: Subcutaneous"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Pharmaceutical form: Solution for injection Route of administration: Subcutaneous"},{"intervention_type":"Drug","name":"Drug: Any Inhaled Corticosteroids as prescribed by treating physician as standard of care","description":"Pharmaceutical form:Aerosol or Dry Powder inhaler Route of administration: Inhaled"},{"intervention_type":"Drug","name":"Drug: Any Long Acting Beta Agonist as prescribed by treating physician as standard of care","description":"Pharmaceutical form:Aerosol or Dry Powder inhaler Route of administration: Inhaled"},{"intervention_type":"Drug","name":"Drug: Any Long Acting Muscarinic Agonist as prescribed by treating physician as standard of care","description":"Pharmaceutical form:Aerosol or Dry Powder inhaler Route of administration: Inhaled"},{"intervention_type":"Drug","name":"Drug: Any short-acting  agonist as prescribed by treating physician as standard of care","description":"Pharmaceutical form: Aerosol or Dry Powder inhaler Route of administration: inhaled"}],"outcomes":[{"outcome_type":"primary","measure":"Rate of moderate-to-severe acute Exacerbations in chronic obstructive pulmonary disease (AECOPD) patients","time_frame":"Over up to 52 weeks treatment period","description":"Annualized rate of moderate-to-severe AECOPD over up to 52 weeks."},{"outcome_type":"secondary","measure":"Change in pre-bronchodilator forced expiratory volume in 1 second (FEV1)","time_frame":"Baseline to Week 16-24","description":"Average change in pre-bronchodilator FEV1 from Week 16 to Week 24."},{"outcome_type":"secondary","measure":"Time to first COPD Exacerbation","time_frame":"Up to 52 weeks","description":"Time to first moderate or severe AECOPD."},{"outcome_type":"secondary","measure":"Adverse Events","time_frame":"Screening up to 72 weeks","description":"Monitor treatment emergent adverse events and serious adverse events."},{"outcome_type":"secondary","measure":"Change in post-bronchodilator FEV1","time_frame":"Baseline to Week 24","description":"Change from baseline to Week 24 in FEV1 (post-bronchodilator)."}]}
{"nct_id":"NCT03372096","start_date":"2018-07-13","phase":"N/A","enrollment":18,"brief_title":"LC Bead LUMI for Prostatic Artery Embolization","official_title":"LC Bead LUMI for Prostatic Artery Embolization: A Pilot Study","primary_completion_date":"2020-09-03","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-09-03","last_update":"2021-02-24","description":"Purpose: The purpose of this pilot study is to determine preliminary estimates of the parameters related to the distribution of the study endpoints including: International Prostate Symptom Score (IPSS) and quality of life (QoL) score changes, Qmax (maximum urine flow rate) changes, post void residual volume (PVR) changes, percent prostate infarction and presence of non-target embolization. Participants: 20 adult male subjects with benign hyperplasia will be enrolled in this study. Procedures (methods): This will be a multisite, open label pilot study with a small population undergoing an investigational intervention (prostatic artery embolization) to determine initial safety and potential for efficacy as measured by improvement of lower urinary tract symptoms (LUTS) and decrease in prostate size.","other_id":"17-2782","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"This will be an open label pilot study with a small population undergoing an intervention to determine initial safety and potential for efficacy as measured by improvement of LUTS and decrease in prostate size","sampling_method":"","gender":"Male","minimum_age":40,"population":"","criteria":"\n        Inclusion Criteria\r\n\r\n          1. Male\r\n\r\n          2. Age > 40\r\n\r\n          3. Prostate gland >50 grams as measured by pre-procedural CT angiogram (CTA)\r\n\r\n          4. Have previously taken BPH medication for 6 months without desired improvement of LUTS\r\n             or has started medication and stopped due to unwanted side effects\r\n\r\n          5. Moderate to severe LUTS as defined by IPSS score >18\r\n\r\n          6. Peak urine flow rate (Qmax) <12 mL/sec\r\n\r\n          7. Capable of giving informed consent\r\n\r\n          8. Life expectancy greater than 1 year\r\n\r\n        Exclusion Criteria\r\n\r\n          1. Severe vascular disease\r\n\r\n          2. Uncontrolled diabetes mellitus\r\n\r\n          3. Immunosuppression\r\n\r\n          4. Neurogenic bladder and/or sphincter abnormalities secondary to Parkinson's disease,\r\n             multiple sclerosis, cerebral vascular accident, diabetes, etc.\r\n\r\n          5. Complete urinary retention\r\n\r\n          6. Impaired kidney function (serum creatinine level > 1.8 mg/dL or a glomerular\r\n             filtration rate < 60 as approximated using serum creatinine levels) unless anuric and\r\n             on dialysis.\r\n\r\n          7. Confirmed or suspected bladder cancer\r\n\r\n          8. Urethral strictures, bladder neck contracture, or other potentially confounding\r\n             bladder pathology\r\n\r\n          9. Ongoing urogenital infection\r\n\r\n         10. Previous pelvic radiation or radical pelvic surgery\r\n\r\n         11. Confirmed or suspected malignancy of the prostate based on digital rectal exam (DRE),\r\n             transrectal ultrasonography (TRUS) or prostate-specific antigen (PSA) (> 10 ng/mL or >\r\n             4.0 ng/mL and < 10 ng/mL with free PSA < 25% of total PSA without a negative biopsy).\r\n\r\n         12. Uncorrectable coagulopathy including international normalized ratio (INR) > 1.5 or\r\n             platelets < 50,000\r\n\r\n         13. Contrast hypersensitivity refractory to standard medications (antihistamines,\r\n             steroids)\r\n      ","sponsor":"University of North Carolina, Chapel Hill","sponsor_type":"Other","conditions":"BPH","interventions":[{"intervention_type":"Device","name":"Device: Prostatic Artery Embolization","description":"LC Bead LUMI is a spherical polyvinyl alcohol embolic particle that incorporates radiopaque moieties. Once a catheter has been fluoroscopically guided into the target vessel, the beads are then injected, causing obstruction at the arteriole level until the desired degree of embolization has occurred."}],"outcomes":[{"outcome_type":"primary","measure":"Mean Change in IPSS Score","time_frame":"Baseline and 6 months following PAE procedure","description":"The International Prostate Symptom Score (IPSS) is an 8 item Likert questionnaire (7 symptom questions + 1 quality of life question) with scores ranging from 0 to 5, where 0 is less severe. IPSS is a written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Total scores are determined to be Mild (1-7), Moderate (8-19), or Severe (20-35)."},{"outcome_type":"secondary","measure":"Mean Change in Quality of Life Scores","time_frame":"Baseline and 6 months following PAE procedure","description":"The QoL question is a single question included with the IPSS related to the symptoms of the disease benign prostatic hyperplasia (BPH). Lower scores indicate a higher quality of life. The range of this scale is 0 to 5."},{"outcome_type":"secondary","measure":"Mean Change in Urine Flow","time_frame":"Baseline and 6 months following PAE Procedure","description":"Urine flow will be measured to determine the maximum rate of urine flow (Qmax), which is measured in mL per second."},{"outcome_type":"secondary","measure":"Mean Change in Prostate Volume","time_frame":"Baseline and 3 months following","description":"Change in the prostate volume measured in grams."},{"outcome_type":"secondary","measure":"Percent of Prostate Infarcted","time_frame":"6 months following PAE procedure","description":"Percentage of prostate infarcted will be determined using manual demarcation of non-enhancing areas within the prostate on serial axial slices of post contrast CT images. Segmentation software will then be employed to calculate the volume."},{"outcome_type":"secondary","measure":"Number of Participants That Have Non-Targeted Embolization Following the Prostatic Artery Embolization (PAE) Procedure","time_frame":"3 months following PAE procedure","description":"Number of participants that have non-targeted embolization following the prostatic artery embolization (PAE) procedure. Non-target embolization will be determined by comparing non-contrast CT images from pre- and post-PAE scans or clinical symptoms. This will be a binary data point and not a calculation."},{"outcome_type":"secondary","measure":"Number of Participants That Have Minor Complications Following the Prostatic Artery Embolization (PAE) Procedure","time_frame":"Up to 12 months following PAE procedure","description":"Number of participants that experience minor complications following the PAE procedure."},{"outcome_type":"secondary","measure":"Mean Change in IIEF Score","time_frame":"Baseline and 6 months following PAE procedure","description":"Change in sexual function as determined by an unchanged or improved score on the International Index of Erectile Function (IIEF) questionnaire. The International Index of Erectile Function is a 15 question tool that measures erectile function (30 max), orgasmic function (10 max), sexual desire (10 max), intercourse satisfaction (15 max), and overall satisfaction (10 max). The total maximum score is 75. Higher scores indicated higher levels of sexual function."}]}
{"nct_id":"NCT03613662","start_date":"2018-07-13","phase":"Phase 1","enrollment":19,"brief_title":"A Research Study to Characterize the Pharmacodynamics and Safety of Repeat Dose SP-102","official_title":"An Open-label, Single-arm Study to Characterize the Pharmacodynamics and Safety of Repeat Dose SP-102 Administered by Epidural Injection in Subjects With Lumbosacral Radiculopathy","primary_completion_date":"2019-03-15","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-03-15","last_update":"2020-01-03","description":"This is an open-label, single-arm, repeat dose study to characterize the pharmacodynamics and safety/tolerability of SP-102 administered by epidural injection.","other_id":"SP-102-03","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Main Inclusion Criteria:\r\n\r\n          -  Able and willing to read, write, and understand the English language and provide\r\n             English language written informed consent prior to beginning any study procedures.\r\n\r\n          -  Age 18 to 70 years (inclusive) at the Screening Visit.\r\n\r\n          -  A diagnosis of lumbosacral radicular pain (sciatica).\r\n\r\n          -  Agrees to follow study-specific medication requirements.\r\n\r\n          -  If sexually active and a female of child-bearing potential or a male capable of\r\n             bearing a child, agrees to use an effective method of birth control during the study.\r\n\r\n          -  Has reviewed all study specific materials and has, in the opinion of the Investigator,\r\n             the abilities to understand and appropriately complete all study procedures.\r\n\r\n        Main Exclusion Criteria:\r\n\r\n          -  Has radiologic evidence of a condition that would compromise study outcomes.\r\n\r\n          -  Has ever had lumbosacral back surgery or plans to undergo spine surgical intervention\r\n             while in the study.\r\n\r\n          -  Has been diagnosed with insulin dependent diabetes mellitus.\r\n\r\n          -  Presence of any other disorder, condition or circumstance (including secondary gain)\r\n             that, in the opinion of the Investigator, has the potential to prevent study\r\n             completion and/or to have a confounding effect on outcome assessments.\r\n\r\n          -  Use of any investigational drug and/or device within 30 days, or is scheduled to\r\n             receive an investigational drug other than blinded study drug during this study.\r\n\r\n          -  Has a body mass index 40 kg/m2.\r\n      ","sponsor":"Semnur Pharmaceuticals, Inc.","sponsor_type":"Industry","conditions":"Lumbosacral Radicular Pain","interventions":[{"intervention_type":"Drug","name":"Drug: SP-102","description":"Injection"}],"outcomes":[{"outcome_type":"primary","measure":"Change in plasma cortisol in mcg/dL","time_frame":"Baseline, 12 Weeks"},{"outcome_type":"primary","measure":"Change of white blood cell counts in 10^3/mcL","time_frame":"Baseline, 12 Weeks"},{"outcome_type":"primary","measure":"Change in blood glucose in mg/dL","time_frame":"Baseline, 12 Weeks"}]}
{"nct_id":"NCT03884959","start_date":"2018-07-12","phase":"Phase 2","enrollment":0,"brief_title":"A Safety and Efficacy Study of Infusions of HepaStem in Urea Cycle Disorders Pediatric Patients","official_title":"A Prospective, Open Label, Safety and Efficacy Study of Infusions of HepaStem in Urea Cycle Disorders Pediatric Patients","primary_completion_date":"2020-11-04","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2020-11-04","last_update":"2020-11-06","description":"This is a phase2, prospective, open label study designed to investigate the safety and efficacy of several infusions of HepaStem. This study will include 5 pediatric Urea Cycle Disorder (UCD) patients under 12 years old. Its assessment includes all safety parameters and an efficacy assessment based on 13C tracer tests, ammonia, medication and diet changes. HepaStem will be administered in addition to the conventional UCD treatments.","other_id":"HEP002KR","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"This is a single group, open label study","sampling_method":"","gender":"All","maximum_age":12,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  The patient is a pediatric patient <12 years\r\n\r\n          -  The patients presents with one of the following UCDs. (CPS1D, OTCD, ASSD, ASLD, ARGD)\r\n\r\n          -  The patient has severe disease with impaired protein tolerance defined as: chronic\r\n             protein restricted diet AND chronic treatment with at lease one nitrogen scavenger.\r\n\r\n          -  The patient shows patency of the portal vein and its branches including mesenteric\r\n             veins, with normal flow velocity as confirmed by Doppler US and accessibility of the\r\n             portal vein and/or affluents.\r\n\r\n          -  The patient (if capable of signing) and parents or legal representative have signed a\r\n             written informed consent form.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  The patient presents acute liver failure.\r\n\r\n          -  The patient presents clinical or radiological evidence of liver cirrhosis.\r\n\r\n          -  The patient presents or has a history of hepatic or extrahepatic malignancy.\r\n\r\n          -  The patient has a known clinically significant cardiac malformation.\r\n\r\n          -  The patient has a personal history of venous thrombosis, or has a clinically\r\n             significant abnormal value for protein S, protein C, anti-thrombin III, and/or\r\n             activated Protein C Resistance (aPCR) at screening. In case of known family history, a\r\n             complete coagulation work-up should be performed. in all above described cases,\r\n             results need to be discussed with sponsor before enrolling the patient in the study.\r\n\r\n          -  Patient currently receiving other unapproved investigational drug or device.\r\n\r\n          -  The patient underwent previous mature liver cell or stem cell transplantation or\r\n             received an organ liver transplant or received HepaStem infusion.\r\n\r\n          -  The patient has a contraindication to methylprednisolone, tacrolimus.\r\n\r\n          -  The patient has a known hypersensitivity or allergy to heparin.\r\n\r\n          -  The patient has a known hypersensitivity or allergy to the antibiotics preventing\r\n             post-operative infections that are prescribed according to institutional guidelines,\r\n             and no alternative prophylaxis can be found.\r\n\r\n          -  The patient had or has a renal insufficiency treated by dialysis.\r\n\r\n          -  The patient requires valproate therapy.\r\n\r\n          -  The patient has a known hypersensitivity or allergy to contrast agents (if applicable)\r\n             that cannot be treated adequately.\r\n\r\n          -  The patient has a thrombosis of the portal vein or persisting impairment of\r\n             anterograde portal blood flow.\r\n\r\n          -  The patient has a porto systemic shunt or fistula assessed by Doppler US or an\r\n             Arantius channel or protal hypertension.\r\n\r\n          -  The site where the catheter is intended to be placed has previously suffered from\r\n             venous thrombosis or vascular surgical procedures.\r\n\r\n          -  The patient has an ongoing infection or suffered from an infection in the last 2 weeks\r\n             (including active EBV infection at screening). The patient may be enrolled after\r\n             resolution of the infection.\r\n\r\n          -  There is any significant condition or disability that, in the investigator's opinion,\r\n             may interfere with the patient's participation in the study.\r\n      ","sponsor":"HLB Cell Co., Ltd.","sponsor_type":"Industry","conditions":"Urea Cycle Disorder","interventions":[{"intervention_type":"Biological","name":"Biological: HepaStem Infusion","description":"HepaStem will be infused intravenously into the portal vein, either (1) via a permanent mesenteric PAC inserted surgically in an affluent of the portal vein; or (2) through a transient percutaneous transhepatic catheter inserted in to the portal vein under radio guidance."}],"outcomes":[{"outcome_type":"primary","measure":"Change of ureagenesis","time_frame":"at 6 months after the first infusion","description":"Change of de novo ureagenesis at 6 months after the first infusion:\r\nabsolute 13C blood urea AUC-120 min quantified with the 13C Tracer method at FU visit 3 compared with baseline evaluations."},{"outcome_type":"primary","measure":"Hemodynamics (measurement of portal vein pressures)","time_frame":"up to 12 months after the first infusion","description":"Safety evaluation in terms of portal-vein hemodynamics"},{"outcome_type":"primary","measure":"Number of subjects with anti-HLA antibody","time_frame":"up to 12 months after the first infusion","description":"Safety evaluation in terms of de novo detection of donor-specific circulating anti-HLA antibodies and/or other immune-related markers"},{"outcome_type":"primary","measure":"Number of subjects with SAEs and AEs","time_frame":"up to 12 months after the first infusion","description":"Safety evaluations in terms of SAEs and clinically significant AEs related to study procedures"},{"outcome_type":"secondary","measure":"Change of ureagenesis","time_frame":"at 3, 9 and 12 months after the first infusion","description":"Change of de novo ureagenesis at 3, 9 and 12 months after the first infusion:\r\nabsolute 13C blood urea AUC-120 min quantified with the 13C Tracer method at FU visit 1, 5 and 7 compared with baseline evaluations."},{"outcome_type":"secondary","measure":"Change of chronic protein intake","time_frame":"Up to 12 months after the first infusion","description":"Chronic protein intake (total and natural protein, reported in mg/kg/day and reported as compared to WHO safe level for age) considering diet evaluations at study visits during baseline period and at scheduled study visits during the follow-up period."},{"outcome_type":"secondary","measure":"Change of chronic nitrogen scavenger dose","time_frame":"Up to 12 months after the first infusion","description":"Chronic nitrogen scavenger dose (mg/kg/day) considering reported doses at scheduled study visits during baseline period and at scheduled study visits during the follow-up period."},{"outcome_type":"secondary","measure":"Change of the level of blood ammonia","time_frame":"Up to 12 months after the first infusion","description":"Blood ammonia considering values measured at scheduled study visits during screening and baseline periods ant at scheduled study visits during the follow-up period."},{"outcome_type":"secondary","measure":"Change of relevant blood amino acids values","time_frame":"Up to 12 months after the first infusion","description":"Relevant blood amino acids considering values measured at scheduled study visits during the screening and baseline periods and at scheduled study visits during the follow-up period."},{"outcome_type":"secondary","measure":"Number of subjects with Metabolic decompensations","time_frame":"Up to 12 months after the first infusion","description":"Metabolic decompensations (hyperammonemia episodes with evocative symptomatology such as drowsiness, gastrointestinal symptoms and treated at hospital), considering all collected events during screening and baseline periods, during active treatment period, during follow-up period."},{"outcome_type":"secondary","measure":"Change of chronic single amino acid intake","time_frame":"Up to 12 months after the first infusion","description":"Chronic single animo acid intake considering reported doses at study visits during baseline period and at study visits during the follow-up period."},{"outcome_type":"secondary","measure":"Evaluation of cognitive skill","time_frame":"Up to 12 months after the first infusion","description":"Change of patient's cognitive skill score between the baseline period (at Baseline visit 1) and the follow-up period (at Follow up visit 7) will be evaluated by the Bayley Scales of Infant Development. (7 classes, from extremely low to very superior)"},{"outcome_type":"secondary","measure":"Evaluation of Behavior indicator","time_frame":"Up to 12 months after the first infusion","description":"Behavior indicator will be evaluated by the Child Behavior Checklist (CBCL) at Baseline visit 1, during follow-up period at 4.5 months, 7.5 months and 12 months post-first fusion (at Follow up visit 2, 4, 7)"},{"outcome_type":"secondary","measure":"Evaluation of health-related Quality of Life (QoL) indicator","time_frame":"Up to 12 months after the first infusion","description":"Health-related QoL indicator will be evaluated by the Pediatric Quality of Life Inventory at Baseline visit 1, during follow-up period at 4.5 months, 7.5 months and 12 months post-first fusion (at Follow up visit 2, 4, 7)"}]}
{"nct_id":"NCT03617185","start_date":"2018-07-12","phase":"N/A","enrollment":140,"brief_title":"Effect of Exercise and Surgical Weight Loss on Polyneuropathy","official_title":"The Effect of High Intensity Interval Training and Surgical Weight Loss on Distal Symmetric Polyneuropathy Outcomes","primary_completion_date":"2024-01-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2024-06-30","last_update":"2020-11-10","description":"The purpose of this research study is to evaluate how exercise and surgical weight loss affect how likely an individual is to develop peripheral neuropathy and other neurologic complications.","other_id":"HUM00143541","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","intervention_model_description":"Patients will be assigned to one of 4 arms, bariatric surgery/HIIT, bariatric surgery/routine exercise, no bariatric surgery/HIIT, no bariatric surgery/routine exercise.","sampling_method":"","gender":"All","minimum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Attending a bariatric surgery clinic\r\n\r\n          -  BMI > 35 with one comorbid condition present or BMI > 40 without comorbid conditions\r\n             present\r\n\r\n          -  Willing and capable to sign the Institutional Review Board (IRB) approved consent form\r\n             and cooperate with the medical procedures for the study duration\r\n\r\n          -  Willing to accept random treatment assignment to HIIT or routine exercise counseling\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of distal symmetric polyneuropathy (DSP) from causes other than diabetes\r\n             and/or the metabolic syndrome as determined through medical history, family history,\r\n             history of medications, occupational history, history of exposure to toxins, physical\r\n             and neurological examinations;\r\n\r\n          -  Use of warfarin, heparin, or other anticoagulants, which would increase the risk of\r\n             complications from skin biopsy\r\n\r\n          -  Contraindication to HIIT participation including a failed exercise stress test\r\n\r\n          -  Participation in an experimental medication trial within 3 months of starting the\r\n             study\r\n\r\n          -  Undergoing therapy for malignant disease other than basal-cell or squamous-cell skin\r\n             cancer\r\n\r\n          -  Medical or psychiatric reason for not being a surgical candidate\r\n\r\n          -  Requiring a walking assist device;\r\n\r\n          -  Currently smoking\r\n      ","sponsor":"University of Michigan","sponsor_type":"Other","conditions":"Polyneuropathies|Obesity|Bariatric Surgery Candidate","interventions":[{"intervention_type":"Other","name":"Other: High Intensity Interval Training (HIIT)","description":"Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months."},{"intervention_type":"Other","name":"Other: Routine Exercise","description":"Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation)."},{"intervention_type":"Procedure","name":"Procedure: Bariatric surgery","description":"Patients will undergo bariatric surgery as part of their routine care"}],"outcomes":[{"outcome_type":"primary","measure":"Change in Intraepidermal Nerve Fiber Density (IENFD) at the proximal thigh","time_frame":"Baseline, 3 months, 12 months and 24 months","description":"As assessed by 3mm skin biopsies.Linear mixed effects regression modeling will account for multiple time points of the same measure."},{"outcome_type":"secondary","measure":"Change in Intraepidermal Nerve Fiber Density (IENFD) at distal leg.","time_frame":"Baseline, 3 months, 12 months and 24 months","description":"As assessed by 3mm skin biopsies. Linear mixed effects regression modeling will account for multiple time points of the same measure."},{"outcome_type":"secondary","measure":"Corneal Confocal Microscopy (CCM)","time_frame":"Baseline, 3 month, 12 months and 24 months"},{"outcome_type":"secondary","measure":"24-2 Frequency Doubling Technology (FDT)","time_frame":"Baseline, 3 month, 12 months and 24 months"},{"outcome_type":"secondary","measure":"Retinal Fundus Photography","time_frame":"Baseline, 3 month, 12 months and 24 months"},{"outcome_type":"secondary","measure":"Nerve Conduction Study (NCS)","time_frame":"Baseline and 24 months","description":"Sural, peroneal, and tibial nerves."},{"outcome_type":"secondary","measure":"Cardiac Autonomic Neuropathy Testing","time_frame":"Baseline and 24 months","description":"Deep breathing-E:I ratio"},{"outcome_type":"secondary","measure":"Cardiac Autonomic Neuropathy Testing","time_frame":"Baseline and 24 months","description":"Postural change-30:15 ratio"},{"outcome_type":"secondary","measure":"Cardiac Autonomic Neuropathy Testing","time_frame":"Baseline and 24 months","description":"Valsalva- Valsalva ratio"},{"outcome_type":"secondary","measure":"Incidence of polyneuropathy as defined by the Toronto definition of probable neuropathy","time_frame":"24 months","description":"Toronto definition of probable neuropathy-2 out of 3 of abnormal sensory examination, reflexes, and symptoms."},{"outcome_type":"secondary","measure":"Michigan Neuropathy Screening Instrument (MNSI)","time_frame":"Baseline, 3 month, 12 months and 24 months"},{"outcome_type":"secondary","measure":"Utah Early Neuropathy Score","time_frame":"Baseline, 3 month, 12 months and 24 months","description":"Scale 0-48, higher is more severe polyneuropathy"},{"outcome_type":"secondary","measure":"Modified Toronto Neuropathy Score (mTNS)","time_frame":"Baseline, 3 month, 12 months and 24 months","description":"Range 0-33, higher is more severe polyneuropathy"},{"outcome_type":"secondary","measure":"Survey of Autonomic Symptoms (SAS)","time_frame":"Baseline, 3 month, 12 months and 24 months"},{"outcome_type":"secondary","measure":"Diabetic Neuropathy Score (DNS)","time_frame":"Baseline, 3 month, 12 months and 24 months","description":"Range 0-4, >/=1 indicates polyneuropathy"},{"outcome_type":"secondary","measure":"Short Form McGill Pain Questionnaire","time_frame":"Baseline, 3 months, 12 months, 24 months"},{"outcome_type":"secondary","measure":"Numerical Rating Scale for pain","time_frame":"Baseline, 3 months, 12 months, 24 months","description":"Range 0-10, higher score indicates more pain"},{"outcome_type":"secondary","measure":"Neuropathy Quality of Life (NeuroQOL)","time_frame":"Baseline, 3 months, 12 months, and 24 months"},{"outcome_type":"secondary","measure":"Berg Balance Scale","time_frame":"Baseline, 3 months, 12 months, and 24 months","description":"Range 0-56, higher score indicates less likely to fall"},{"outcome_type":"secondary","measure":"8 Foot Get Up and Go Test","time_frame":"Baseline, 3 months, 12 months, and 24 months"},{"outcome_type":"secondary","measure":"Modified Falls Efficacy Scale","time_frame":"Baseline, 3 months, 12 months, and 24 months","description":"Range 0-140, higher score indicates less likely to fall"},{"outcome_type":"secondary","measure":"Neurothesiometer","time_frame":"Baseline, 3 months, 12 months, and 24 months"},{"outcome_type":"secondary","measure":"NIH Toolbox Cognitive Battery","time_frame":"Baseline and at 24 months"},{"outcome_type":"secondary","measure":"Rey Auditory Verbal Learning Test","time_frame":"Baseline and at 24 months"}]}
{"nct_id":"NCT03417024","start_date":"2018-07-12","enrollment":13,"brief_title":"Automated Breast Ultrasound Case Collection Registry","official_title":"Automated Breast Ultrasound Case Collection Registry","primary_completion_date":"2019-01-25","study_type":"Observational [Patient Registry]","rec_status":"Terminated","completion_date":"2019-01-25","last_update":"2019-09-09","description":"The contribution of automated breast ultrasound (ABUS) to the screening pathway for breast cancer is not fully understood. This prospective study aims to collect longitudinal data in women with dense breasts undergoing ABUS as a supplement to digital breast tomosynthesis (DBT). The data are intended for use in future research on the value and effectiveness of ABUS in routine clinical care. Data will be collected from eligible women who have been prescribed or have completed DBT and ABUS, screening within a 30-day window. Radiologist evaluations and, when performed, outcomes of biopsy and/or laboratory testing will be recorded. Subjects will be followed for breast cancer status and results of any diagnostic breast exams and/or treatment.","other_id":"110.01-2016-GES-0001","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"Female","minimum_age":18,"population":"This study will enroll adult women with dense breasts clinically referred for breast cancer\r\n        screening.","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Are asymptomatic adult women (aged 18 years or older);\r\n\r\n          2. Are eligible to complete or have completed (within 30 days) screening ABUS and DBT\r\n             exams per the site standard of care;1\r\n\r\n          3. Have heterogeneously dense and extremely dense breasts (BI-RADS C or D, respectively)\r\n             or are determined to have dense breasts prior to the study on initial screening\r\n             mammography;\r\n\r\n          4. Are able and willing to participate.\r\n\r\n        Exclusion Criteria:\r\n\r\n        1. Have a breast cancer diagnosis (with or without metastasis) or are being treated for\r\n        breast cancer within the year prior to the study.\r\n      ","sponsor":"GE Healthcare","sponsor_type":"Industry","conditions":"Breast Cancer","interventions":[{"intervention_type":"Device","name":"Device: Automated Breast Ultrasound","description":"The ABUS system is designed to methodically scan a breast and capture multiple ultrasound images that can be rendered and reviewed in three dimensions."},{"intervention_type":"Device","name":"Device: Digital Breast Tomosynthesis","description":"Digital Breast Tomosynthesis (DBT) systems are designed to collect 3-dimensional x-ray images of breast tissues."}],"outcomes":[{"outcome_type":"primary","measure":"Number of Complete Breast Imaging Datasets","time_frame":"Up to 6 Years"},{"outcome_type":"secondary","measure":"Type of Exams Performed Per Patient","time_frame":"Up to 6 years"},{"outcome_type":"secondary","measure":"Breast Cancer Status","time_frame":"Up to 6 years"}]}
{"nct_id":"NCT03600103","start_date":"2018-07-11","phase":"N/A","enrollment":120,"brief_title":"Technology Based Community Health Nursing to Improve Combination Anti-Retroviral Therapy (cART) Adherence and Virologic Suppression in Youth Living With HIV","official_title":"Technology Based Community Health Nursing to Improve cART Adherence and Virologic Suppression in Youth Living With HIV (TECH-N 2 CHECK-IN): A Regional Multi-site Study","primary_completion_date":"2022-06-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-06-01","last_update":"2020-12-11","description":"Human immunodeficiency virus (HIV) infection has disproportionately persisted as a public health threat to adolescents and young adults (AYA) from minority communities in the United States. HIV has evolved into a chronic disease, which can be managed in the outpatient setting with antiretroviral therapy (ART) designed to achieve virologic suppression and life expectancy equivalent for uninfected individuals. Community health nurse (CHN) interventions have been shown to increase access to appropriate resources, enhance health care utilization, and promote risk-reducing behavior among AYA. Use of short messaging service (SMS) messaging can further enhance clinical care by improving attendance at medical visits, medication adherence, and communication with the health care team.Investigators have used these two modalities in randomized trials of youth with complex sexually transmitted infections (STIs) in low-income minority communities with high feasibility and acceptability amongst AYA and families, remarkable improvements in visit completion, medication adherence, and reduction in recurrent STIs. The overarching goal of this project is to build on the evidence from this trial and to re-purpose the intervention for Young people living with HIV (YLHIV) in the same community who are having challenges with care and medication non-adherence.Investigators aim to compare the effectiveness of a technology-enhanced community health nursing intervention (TECH2CHECK) to a standard of care control group using a randomized trial design. The central hypothesis is that the intervention will result in higher rates of adherence to ART and virologic suppression. Investigators have demonstrated investigators' interdisciplinary team's capacity to follow urban AYA in the community, utilizing the combination of CHNs and outreach workers to optimize care according to national standards. TECH2CHECK aims to enroll 120 YLHIV followed at clinics specializing in HIV care in the Baltimore-Washington Metropolitan area and Jacksonville, Florida who are challenged with treatment adherence and randomizing participants to receive TECH2CHECK vs. standard of care. Results of this trial will inform best practices for engaging YLHIV by addressing the distal component of the continuum, critical to achieving the elusive 90-90-90 HIV goals.","other_id":"IRB00161462","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":12,"maximum_age":25,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Eligible participants should be aged 12-25 years old diagnosed with HIV\r\n\r\n          -  Eligible for ART, VL>20 copies/ml\r\n\r\n          -  English speaking (>95% current clinic population)\r\n\r\n          -  Aware of their HIV status\r\n\r\n          -  Permanently reside in the Baltimore/Washington Metropolitan area or Jacksonville,\r\n             Florida\r\n\r\n          -  Willing to sign informed consent (including allowing communication with the\r\n             participant's primary care provider). Informed consent includes being willing to\r\n             complete study procedures; including randomization and community-based follow-up by\r\n             our team.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Mental health, cognitive, or behavioral dysfunction that in the opinion of the site PI\r\n             would impair effective participation\r\n\r\n          -  Severe illness requiring hospitalization at the time of enrollment. This will be\r\n             assessed at the team meetings designed to generate referrals.\r\n      ","sponsor":"Johns Hopkins University","sponsor_type":"Other","conditions":"HIV Infections|Adherence, Medication","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Tech2Check","description":"The intervention uses behaviors to improve HIV adherence and self-care. Investigators will use the Center for Disease Control (CDC) Partnership for Health (PfH) Medication Adherence.The CHN will administer PfH at all home/venue-based encounters, using communication styles that are more receptive to adolescents and young adults. Resources will be provided. At the end of the session, the participant will be able to state/demonstrate: goals of HIV care and adherence, meaning of CD4 and Viral Load (VL) measurements and the significance of their own measurements,signs of complications or problems for which participants need to seek additional care,understanding of optimal self-care.Further, CHNs will also provide tips to stay on schedule with taking their ART and problem-solve adherence barriers."}],"outcomes":[{"outcome_type":"primary","measure":"Viral suppression","time_frame":"18 months","description":"Viral suppression will be assessed by measuring plasma HIV-1 RNA (copies/mL). Viral suppression is defined as a viral load <20 copies/mL."},{"outcome_type":"secondary","measure":"Management Cost difference","time_frame":"18 months","description":"To compare the cost of TECH2CHECK as compared to Standard of Care (SOC) for management of HIV in the outpatient setting. The costs of administering the different components of TECH2CHECK intervention and the standard of care will be based on a combination of direct observations, project records, and clinic invoices. The amount of staff and patient time (e.g. hours worked for CHN, patient transportation/visit time), consumable supplies (including miles traveled, antiretroviral costs, SMS costs, etc.), and equipment utilized (e.g., cell phones) for the intervention and SOC will be collected. Costs related to other health service utilization will be derived from ACASI, care utilization data."},{"outcome_type":"secondary","measure":"Adherence to care as assessed by patient visits","time_frame":"18 months","description":"We will examine attendance to clinical visits (proportion of appointments attended/appointments scheduled). This will be based on a binary (Yes/No) response to a questionnaire given out to patients."},{"outcome_type":"secondary","measure":"Adherence to care as assessed by HRSA retention measure","time_frame":"18 months","description":"We will also assess whether patients meet the Health Resources and Services Administration (HRSA) retention measure (2 provider visits in a 12-month period, with one appointment in each 6 month period, separated by at least 3 months)"}]}
{"nct_id":"NCT03566394","start_date":"2018-07-02","phase":"Phase 2/Phase 3","enrollment":46,"brief_title":"Prophylactic Gabapentin for Taxane-Induced Arthralgia and Myalgia Syndrome in Breast Cancer Patients Undergoing Adjuvant Chemotherapy","official_title":"Primary Prophylactic Gabapentin for Taxane-Induced Arthralgia and Myalgia Syndrome in Breast Cancer Patients Undergoing Adjuvant Chemotherapy: A Randomized Controlled Trial","primary_completion_date":"2019-06-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2020-06-30","last_update":"2018-06-25","description":"Taxane-induced arthralgia and myalgia syndrome (TAMS) is one of the most common side effects of taxane chemotherapy. This prospective randomized controlled trial will evaluate the efficacy of gabapentin administered prophylactically on days -2 to +5 during the taxane-portion of chemotherapy for adjuvant breast cancer patients on reducing TAMS. This will be compared to observation alone.","other_id":"Gabapentin RCT","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  English-speaking\r\n\r\n          -  Patients must have histologically confirmed, Stage I-III, breast cancer\r\n\r\n          -  Patient is on an 8-cycle adjuvant anthracycline-cyclophosphamide-taxane containing\r\n             chemotherapy regimen, and will be starting the taxane-containing portion of\r\n             chemotherapy within 4 weeks of enrollment.\r\n\r\n          -  Patient has not received prior taxane chemotherapy\r\n\r\n          -  ECOG performance status 0 to 2 (on a scale from 0 to 4, with 0 indicating normal\r\n             activity, 1 symptomatic but ambulatory self-care possible, 2 ambulatory more than 50%\r\n             of the time, 3 ambulatory 50% of the time or less and nursing care required, and 4\r\n             bedridden and possibly requiring hospitalization)\r\n\r\n          -  Ability to understand and the willingness to sign a written informed consent document\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients on FEC-D, ACTW, DCx4 chemotherapy.\r\n\r\n          -  Metastatic disease\r\n\r\n          -  Patient currently taking gabapentin or pregabalin for other indications prior to\r\n             initiating chemotherapy\r\n\r\n          -  Patients concomitantly taking other drugs known to influence GABA (e.g. barbituates,\r\n             benzodiazepines, nonbenzodiazepines, baclofen)\r\n\r\n          -  Patients using selected analgesics (opioids, acetaminophen, aspirin, NSAIDs) in which\r\n             the dosages have changed in the 2 weeks prior to starting Taxane chemotherapy, or an\r\n             analgesic medication was discontinued in the last 2 weeks, or a new analgesic\r\n             medication was started in the last 2 weeks.\r\n\r\n          -  Patients concomitantly using medical marijuana\r\n\r\n          -  Known restricting adverse events or allergy to gabapentin or pregabalin supplements.\r\n\r\n          -  GFR less than 30ml/min\r\n\r\n          -  Myalgia and/or arthralgia unrelated to chemotherapy, or severe pain syndromes, that\r\n             could confound the results.\r\n      ","sponsor":"British Columbia Cancer Agency","sponsor_type":"Other","conditions":"Myalgia|Invasive Breast Cancer|Chemotherapeutic Toxicity|Arthralgia","interventions":[{"intervention_type":"Drug","name":"Drug: Gabapentin 300mg","description":"Gabapentin 300mg orally three times a day, from 2 days before to 5 days after taxane infusion"}],"outcomes":[{"outcome_type":"primary","measure":"\"Worst\" pain score","time_frame":"Approximately 8 months","description":"Brief Pain Inventory-short form assessment tool"},{"outcome_type":"secondary","measure":"Arithmetic mean of the four severity pain score items","time_frame":"Approximately 8 months","description":"Brief Pain Inventory-short form assessment tool"},{"outcome_type":"secondary","measure":"Quality of life and function","time_frame":"Approximately 8 months","description":"FACT-Taxane Scale"},{"outcome_type":"secondary","measure":"Chemotherapy dose reductions, delays, and discontinuation","time_frame":"Approximately 8 months"},{"outcome_type":"secondary","measure":"Incidence and severity of peripheral neuropathy","time_frame":"Approximately 8 months","description":"EORTC-QLQ-CIPN20"},{"outcome_type":"secondary","measure":"Gabapentin-related adverse events","time_frame":"Approximately 8 months"},{"outcome_type":"secondary","measure":"Opioid initiation or modifications","time_frame":"Approximately 8 months"}]}
{"nct_id":"NCT03788122","start_date":"2018-07-01","phase":"N/A","enrollment":40,"brief_title":"Fetal Surgery Interview Study: Parental Perceptions of Fetal Surgery","official_title":"Qualitative In-depth Interviews With Women and Their Partners Concerning the Acceptability of Fetal Surgery","primary_completion_date":"2020-03-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2020-03-31","last_update":"2018-12-27","description":"Open maternal-fetal surgery is currently used on fetuses with myelomeningocele (MMC). Fetoscopic or minimal access fetal surgery is also being used to treat fetuses with congenital diaphragmatic hernia (CDH). Following accurate diagnosis of a congenital malformation such as MMC or CDH, prospective parents face a range of uncertainties regarding the future of their unborn child, and the options provided require major ethical considerations. In the situation under study, termination of pregnancy may be for some parents an alternative option to expectant prenatal management. Fetal therapy provides a tantalising third option for some, where procedures are undertaken to reduce the likelihood of a more complicated neonatal course, potentially improving long term outcome, but at risk of amniotic fluid leakage, infection and most importantly very preterm delivery, itself associated with significant neonatal mortality and morbidity and long-term consequences. Balancing these competing risks is challenging. For an intervention to be effective it also needs to be acceptable to women and their families. \"Acceptability\" can be defined as a multi-faceted construct that reflects the extent to which people delivering or receiving a healthcare intervention consider it to be appropriate, based on anticipated or experienced cognitive and emotional responses to the intervention. With this study it is the aim to assess how women (and their partners) perceive the acceptability of a fetal surgical intervention for MMC and CDH. Participants will be asked to share their thoughts, views, feelings and experiences with regards to the decision to participate in fetal surgery. Data are collected by the use of in-depth face-to-face interviews. In-depth interviews are used to understand the participant's perspectives and perceptions of a situation they are in. It explicitly includes participants interpretation and understanding of an event The interviews will be held in two or three moments in time (for parents opting for fetal surgery, there will be one additional interview, after the intervention while admitted in hospital): after counselling for options, but before eventual intervention; for intervention group shortly after the intervention, and 12 weeks after birth of the baby, or termination of pregnancy.","other_id":"S61586","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Women/partners eligible for one of the two fetal surgery procedures studied (open\r\n             fetal surgery for spina bifida closure, tracheal balloon occlusion for congenital\r\n             diaphragmatic hernia (Fetoscopic Endoluminal Tracheal Occlusion, FETO), as clinical\r\n             care\r\n\r\n          -  Have given written informed consent for participation\r\n\r\n        Exclusion:\r\n\r\n          -  Women less than 18 years or over 65 years of age\r\n\r\n          -  Partners less than 18 years or over 65 years of age\r\n\r\n          -  Women or their partners who are unable to communicate in either English or the local\r\n             language (if different)\r\n      ","sponsor":"Universitaire Ziekenhuizen Leuven","sponsor_type":"Other","conditions":"Fetal Surgery|Myelomeningocele|Congenital Diaphragmatic Hernia","interventions":[{"intervention_type":"Other","name":"Other: In-depth interview","description":"The 'intervention' administered to this group of participants are two or three in-depth interviews (average 30-60 m minutes per interview) on their experiences, views, feelings and thoughts (perceptions) regarding acceptability of the fetal surgery."}],"outcomes":[{"outcome_type":"primary","measure":"Prospective acceptability of fetal surgery in the context of Myelomeningocele and Congenital Diaphragmatic Hernia.","time_frame":"After evaluation and counseling, if applicable, before undergoing fetal surgery.","description":"Qualitative methodology. Prospective acceptability, as perceived by prospective parents eligible for fetal surgery, assessed by in-depth face-to face interviews."},{"outcome_type":"primary","measure":"Concurrent acceptability of fetal surgery in the context of Myelomeningocele and Congenital Diaphragmatic Hernia.","time_frame":"After fetal surgery, within 7 days after surgery.","description":"Qualitative methodology. Concurrent acceptability, as perceived by prospective parents eligible for fetal surgery, assessed by in-depth face-to face interviews."},{"outcome_type":"primary","measure":"Retrospective acceptability of fetal surgery in the context of Myelomeningocele and Congenital Diaphragmatic Hernia.","time_frame":"Three months after birth of the baby, or three months after termination of the pregnancy.","description":"Qualitative methodology. Retrospective acceptability, as perceived by prospective parents eligible for fetal surgery, assessed by in-depth face-to face interviews."}]}
{"nct_id":"NCT03579966","start_date":"2018-07-01","phase":"Phase 3","enrollment":70,"brief_title":"Long Term Safety Study of Amifampridine Phosphate in MuSK-MG (Muscle Specific Tyrosine Kinase Myasthenia Gravis)","official_title":"Long Term Safety Study of Amifampridine Phosphate in Patients With MuSK Antibody Positive and AChR (Acetylcholine Receptor) Antibody Positive Myasthenia Gravis","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2022-06-30","last_update":"2021-02-16","description":"Evaluate the long-term safety of amifampridine phosphate in the symptomatic relief of antibody positive MuSK-MG.","other_id":"MSK-003","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Participated in the MSK-002 study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Epilepsy and currently on medication\r\n\r\n          -  Clinically significant abnormalities in ECG, in the opinion of the Investigator\r\n      ","sponsor":"Catalyst Pharmaceuticals, Inc.","sponsor_type":"Industry","conditions":"Myasthenia Gravis, MuSK","interventions":[{"intervention_type":"Drug","name":"Drug: Amifampridine Phosphate","description":"tablets equivalent to 10mg amifampridine, titrated to an efficacious and tolerable dose, 3 to 4 times a day"}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)","time_frame":"over 21 months","description":"Evaluate the long-term safety and tolerability amifampridine phosphate through the number of patients with treatment-emergent adverse events mapped to the Medical Dictionary for Regulatory Activities (MedDRA) SOCs and PTs. [ Time Frame: over 21 monts ] Descriptive statistics will be used to summarize study data."}]}
{"nct_id":"NCT03390738","start_date":"2018-06-30","phase":"Phase 2","enrollment":0,"brief_title":"Nivolumab as Treatment for Recurrent/Metastatic Nasopharyngeal Carcinoma After Failing 2 Lines or More Previous Chemotherapy","official_title":"Nivolumab as Treatment for Recurrent/Metastatic Nasopharyngeal Carcinoma After Failing 2 Lines or More Previous Chemotherapy","primary_completion_date":"2019-05-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2019-06-30","last_update":"2021-05-03","description":"A phase II, open label, single arm, single agent study using nivolumab in patients who failed 2 or more lines of previous chemotherapy for recurrent/metastatic NPC (At least 1 line should include platinum based chemotherapy)","other_id":"NPC-1501","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Recurrent or metastatic NPC incurable by local therapies and failed at least 2 lines\r\n             of previous chemotherapy with at least 1 line including platinum based chemotherapy\r\n\r\n          -  Measurable disease (RECIST 1.1)\r\n\r\n          -  ECOG 2 or less\r\n\r\n          -  Life expectancy greater than 3 months\r\n\r\n          -  Adequate organ function\r\n\r\n          -  (Provided tissue for PD-L1 biomarker analysis from a core or excisional biopsy Paired\r\n             biopsy of baseline tissue at first diagnosis and for recurrence if possible) -\r\n             optional but encouraged\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Suitable for local therapy\r\n\r\n          -  Did not have prior platinum chemotherapy\r\n\r\n          -  Immunodeficiency; immunosuppressive treatment\r\n\r\n          -  Anti-cancer monoclonal antibody treatment within 4 weeks prior to Day 1\r\n\r\n          -  Other cancer treatment within 2 weeks prior to Day 1\r\n\r\n          -  Other malignancies (some exceptions)\r\n\r\n          -  CNS metastases; carcinomatous meningitis\r\n\r\n          -  Active temporal lobe necrosis or on steroid treatment\r\n\r\n          -  Autoimmune disease\r\n\r\n          -  Active, non-infectious pneumonitis\r\n\r\n          -  Active infection requiring systemic treatment\r\n\r\n          -  Hepatitis\r\n      ","sponsor":"The University of Hong Kong","sponsor_type":"Other","conditions":"Nasopharyngeal Carcinoma","interventions":[{"intervention_type":"Drug","name":"Drug: Nivolumab","description":"Intravenous nivolumab 240mg every 2 weeks until radiologically-documented disease progression, unacceptable toxicity as judged by investigators or patient withdrawal"}],"outcomes":[{"outcome_type":"primary","measure":"Overall response rate of patients. Response will be assessed by RECISTS 1.1 criteria","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Toxicities as defined by CTCAE criteria","time_frame":"1 year","description":"To characterize the safety and tolerability of nivolumab in subjects with recurrent/metastatic NPC. This will be based on subjects who experienced toxicities as defined by CTCAE criteria, receiving at least one dose of nivolumab."}]}
{"nct_id":"NCT03558542","start_date":"2018-06-30","phase":"N/A","enrollment":20,"brief_title":"Cardiopulmonary Rehabilitation in Chronic Stroke","official_title":"Cardiopulmonary Rehabilitation in Chronic Stroke Patients","primary_completion_date":"2018-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-06-30","last_update":"2018-06-15","description":"This study is aimed to determine the effects of an accompanying structured cardiopulmonary rehabilitation program along with a neurorehabilitation program on the quality of life, care-giver burden and overall well-being of the patients.","other_id":"09.2018.229","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  A history of ischemic stroke at least 6 months ago\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  any cardiac or pulmonary problem that renders the patient unavailable for the program\r\n\r\n          -  mental impairment\r\n\r\n          -  not being able to perform exercise testing\r\n\r\n          -  not being able to walk independently\r\n      ","sponsor":"Marmara University","sponsor_type":"Other","conditions":"Stroke|Hemiplegia","interventions":[{"intervention_type":"Other","name":"Other: cardiopulmonary rehabilitation plus neurorehabilitation","description":"Patients with stroke will undergo an accompanying structured cardiopulmonary rehabilitation program along with a neurorehabilitation program"}],"outcomes":[{"outcome_type":"primary","measure":"VO2max","time_frame":"2 months","description":"Maximum oxygen consumption"}]}
{"nct_id":"NCT04098731","start_date":"2018-06-28","enrollment":90,"brief_title":"Evaluation of Respiratory Function in Fibromyalgia","official_title":"Evaluation of Respiratory Function in People With Fibromyalgia","primary_completion_date":"2021-10-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2022-05-31","last_update":"2021-06-10","description":"This study will evaluate respiratory function in people with fibromyalgia and whether or not breathing patterns in this patient group can be explained by stress, emotional or biomechanical variables. In addition, examine the relationship between physical ability and lactate values.","other_id":"uppsala18","observational_model":"Case-Control","time_perspective":"Cross-Sectional","sampling_method":"Probability Sample","gender":"All","minimum_age":20,"maximum_age":65,"population":"Patients with diagnosed fibromyalgia and healthy subjects included as controls.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female with fibromyalgia according to American College of Rheumatology\r\n             criteria 2010.\r\n\r\n          -  Age 20 to 65 years\r\n\r\n          -  Informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Trauma in neck-shoulder or thoracic region with prolonged symptoms during the last\r\n             three months before examination.\r\n\r\n          -  Severe illness (neurological e.g Parkinson disease, neuromuscular e.g Multiple\r\n             sclerosis, respiratory e.g chronic obstructive pulmonary disease, muscle/skeletal\r\n             disease e.g ankylosing spondylitis)\r\n\r\n          -  Inability to understand or follow instructions in Swedish\r\n\r\n          -  Use of antidepressant drugs\r\n\r\n          -  For the healthy controls, any other complaints from the chest wall and neck and\r\n             shoulder region within three month before examination.\r\n\r\n        N.B Smoking will not be an exclusion criterion.\r\n      ","sponsor":"Uppsala University","sponsor_type":"Other","conditions":"Fibromyalgia|Respiratory Alkalosis and Metabolic Acidosis|Chronic Hyperventilation","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Forced expiratory volume in percentage (FEV%)","time_frame":"Day 1","description":"The forced expiratory volume in percentage will be determined by the ratio of the forced expiratory volume in one second (L/sec) and the forced vital capacity (L). A spirometer is used for these respiratory tests."},{"outcome_type":"primary","measure":"Partial pressure of carbon dioxide","time_frame":"Day 1","description":"An arterial (radial) blood gas test will be performed to measure the carbon dioxide partial pressure (kPa)."},{"outcome_type":"secondary","measure":"Respiratory rate","time_frame":"Day 1","description":"Respiratory rate is the number of breaths a person take per minute (number per minute). Respiratory rate will be measured by using intensive care equipment. Electrodes will be placed under each clavicle and over the lower ribs on the left side. The equipment sense the distance between the electrodes i.e the movement of the chest wall. After five minutes of relaxing, respiratory rate is measured during one minute."}]}
{"nct_id":"NCT03212352","start_date":"2018-06-27","phase":"Phase 4","enrollment":342,"brief_title":"Comparing Two Medical Treatments for Early Pregnancy Failure.","official_title":"Mifepristone and Misoprostol Versus Misoprostol Alone for Uterine Evacuation After Early Pregnancy Failure: a Randomized Double Blind Placebo-controlled Comparison (Triple M Trial)","primary_completion_date":"2020-01-23","study_type":"Interventional","rec_status":"Terminated","completion_date":"2020-03-16","last_update":"2020-05-01","description":"This study aims to compare whether a combination of two drugs (Mifepristone and misoprostol) are superior compared to using only one of these drugs (Misoprostol) as medical treatment for a miscarriage. Women in whom early pregnancy failure, 6-14 weeks postmenstrual, is ultrasonographically confirmed qualify for this study. It is expected that the combination of Mifepristone and Misoprostol is more effective in reaching complete evacuation, and therefore can prevent more invasive treatment such as curettage.","other_id":"62449","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","intervention_model_description":"Before medical treatment with misoprostol (two doses 400mcg (four hours apart), repeated after 24 hours if no tissue is lost), patients will be randomized to oral mifepristone (600mg) or oral placebo (identical in appearance).","sampling_method":"","gender":"Female","minimum_age":16,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Early pregnancy failure, 6-14 weeks postmenstrual with\r\n\r\n          -  a crown-rump length  6mm and no cardiac activity OR\r\n\r\n          -  a crown-rump length <6mm and no fetal growth at least one week later OR\r\n\r\n          -  a gestational sac with absent embryonic pole for at least one week.\r\n\r\n               -  At least one week after diagnosis OR a discrepancy of at least one week between\r\n                  crown-rump length and calendar gestational age\r\n\r\n               -  Intra-uterine pregnancy\r\n\r\n               -  Women aged above 16 years\r\n\r\n               -  Hemodynamic stable patient\r\n\r\n               -  No signs of infection\r\n\r\n               -  No signs of incomplete abortion\r\n\r\n               -  No contraindications for mifepristone or misoprostol\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patient does not meet inclusion criteria, discovered after randomization\r\n\r\n          -  Inability to give informed consent\r\n\r\n          -  Known clotting disorder or use of anticoagulants\r\n\r\n          -  Known risk factors for, or presence of, a cardiovascular disease\r\n\r\n          -  Language barrier\r\n      ","sponsor":"Radboud University","sponsor_type":"Other","conditions":"Early Pregnancy Failure","interventions":[{"intervention_type":"Drug","name":"Drug: Mifepristone","description":"Adding 600 mg of Mifepristone to the regular treatment with Misoprostol 800 mcg."},{"intervention_type":"Drug","name":"Drug: Misoprostol","description":"Regular treatment with Misoprostol 800 mcg."}],"outcomes":[{"outcome_type":"secondary","measure":"complications","time_frame":"six weeks after treatment","description":"How many and which complications have occured?"},{"outcome_type":"secondary","measure":"side effects","time_frame":"six weeks after treatment","description":"Which side effects have patients experienced and to what degree?"},{"outcome_type":"secondary","measure":"Overall quality of health, as experienced by the patient.","time_frame":"At baseline, day four, and two and six weeks after initial treatment.","description":"To measure the quality of the health status of the patients,a validated so-called health-related quality of life (HRQoL) instrument will be used: the EuroQol-5D."},{"outcome_type":"secondary","measure":"Overall quality of health, as experienced by the patient.","time_frame":"At baseline, day four, and two and six weeks after initial treatment.","description":"To measure the quality of the health status of the patients, a validated so-called health-related quality of life (HRQoL) instrument will be used: the Short Form 36 health survey"},{"outcome_type":"secondary","measure":"costs","time_frame":"up to six weeks after treatment","description":"To evaluate which medical treatment strategy is cost-effective, volumes of health care consumed will additionally be measured prospectively alongside the clinical trial together with cost associated with productivity losses. Costs of medical interventions (direct costs) and costs resulting from productivity loss (indirect costs) will be taken into account. Resource uses will be recorded in the case report forms. Standardized unit costs will be calculated using the Dutch manual for costing in economic evaluations and standardised costs."},{"outcome_type":"primary","measure":"Complete evacuation","time_frame":"six weeks after initial treatment","description":"Whether or not complete evacuation (total endometrial thickness <15 mm) has been acquired will be assessed through ultrasonography."},{"outcome_type":"secondary","measure":"patient satisfaction","time_frame":"At baseline, day four, two and six weeks after treatment","description":"To assess how satisfied patient are with the treatment they underwent. Patient satisfaction with treatment will be measured using The Client Satisfaction Questionnaire (CSQ-8, digital)"}]}
{"nct_id":"NCT04504474","start_date":"2018-06-21","enrollment":500,"brief_title":"Network Analysis of Adult MDD and ADHD","official_title":"Network Analysis of Co-morbid Symptoms of Adult Major Depressive Disorder and Attention-deficit Hyperactivity Disorder in an Outpatient Population","primary_completion_date":"2021-08-08","study_type":"Observational","rec_status":"Recruiting","completion_date":"2021-09-08","last_update":"2020-08-07","description":"The study is an investigation to determine co-morbid symptoms between adult major depressive disorder (MDD) and adult attention-deficit hyperactivity disorder (ADHD) using a novel statistical technique called network analysis.","other_id":"18-056","observational_model":"Cohort","time_perspective":"Other","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":60,"population":"We will gather a recruitment of 500 male and female outpatients from the Psychiatric\r\n        Outpatient Clinic at Kirkwood Site attached to Health Sciences North.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  participants have a diagnosis of MDD or ADHD or both\r\n\r\n          -  participants are competent to consent to the study\r\n      ","sponsor":"Health Sciences North Research Institute","sponsor_type":"Other","conditions":"ADHD","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Co-morbidity","time_frame":"September 8, 2021","description":"Characterize the ADHD/MDD symptom network in a psychiatric outpatient setting comprised of adults"},{"outcome_type":"primary","measure":"Network reliability","time_frame":"September 8, 2021","description":"Determine the stability and reliability of this network"},{"outcome_type":"primary","measure":"Central symptoms","time_frame":"September 8, 2021","description":"Determine the central symptoms that lead to co-activation of ADHD/MDD clusters"}]}
{"nct_id":"NCT03595501","start_date":"2018-06-20","enrollment":679,"brief_title":"Analytical and Clinical Performance Testing Plan","official_title":"Analytical and Clinical Performance Testing Plan","primary_completion_date":"2019-03-06","study_type":"Observational","rec_status":"Completed","completion_date":"2019-08-25","last_update":"2021-03-04","description":"Clinical and analytical tests will be performed based on risk assessment and system specifications to verify that the performance of the investigational device is in accordance with its specifications.","other_id":"PR00014","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":0.25,"population":"Adult and pediatric patients with normal (healthy) or abnormal blood counts (known clinical\r\n        condition)","criteria":"\n        Inclusion Criteria:\r\n\r\n        For Residual Samples:\r\n\r\n          -  Specimen obtained by venipuncture or finger prick and collected into tubes normally\r\n             used by the site\r\n\r\n          -  Patient is at least 3 months of age\r\n\r\n          -  Samples within 8 hours from phlebotomy\r\n\r\n        For Prospectively collected samples:\r\n\r\n          -  Subject is at least 22 years of age\r\n\r\n          -  Non-diseased individuals or, for specific studies, individuals with blood count ranges\r\n             to cover indicated medical decision points and ranges\r\n\r\n          -  Samples within 8 hours from phlebotomy\r\n\r\n        Exclusion Criteria:\r\n\r\n        Exclusion criteria post blood draw and pre sample scan - For whole blood samples:\r\n\r\n          -  Visibly hemolyzed or clotted specimens\r\n\r\n          -  Specimens with insufficient blood volume to complete the procedure\r\n\r\n          -  Samples older than eight hours\r\n\r\n        Exclusion criteria post sample scan:\r\n\r\n          -  Instrument failure or sample rejected by the instrument due to system error or sample\r\n             mishandling\r\n\r\n          -  The daily quality control sample measurements indicate that the assay run is outside\r\n             the specifications for the instrument\r\n\r\n          -  Operator related error documented in the study records\r\n\r\n          -  Failure to adhere to study specifics or protocols\r\n      ","sponsor":"Sight Diagnostics","sponsor_type":"Industry","conditions":"Hematology|Hematologic Test","interventions":[{"intervention_type":"Device","name":"Device: Hematology Analyzer - OLO","description":"Complete blood counts from OLO will be determined from analysis of whole blood samples"},{"intervention_type":"Device","name":"Device: Hematology Analyzer - Predicate","description":"Complete blood counts from Predicate will be determined from analysis of whole blood samples"}],"outcomes":[{"outcome_type":"primary","measure":"Reproducibility of CBC parameters provided by the OLO device","time_frame":"3 months","description":"Reproducibility studies will be conducted using 3 levels of commercial control materials (low, normal and high) to measure all CBC reported parameters. Control material will be run on two instruments at each site. Standard deviation (SD) and coefficient of variation (CV) will be calculated for each measurand for: (1) Between lots/sites; (2) Between instruments; (3) Between days; (4)Between operators/runs; (5) within-run and (6) total variability"},{"outcome_type":"primary","measure":"Repeatability of CBC parameters provided by the OLO device","time_frame":"3 months","description":"Performance of the OLO device will be measured through repeatability of 20 replicates for 11 residual samples on each site. Samples collected for this study will include 4 within lab reference range, 3 around lower medical decision levels for HGB, PLT and WBC, and 4 around the upper range for RBC, HGB, WBC and PLT to cover all pathological levels and medical decision points. Standard deviation (SD) and coefficient of variation (CV) will be computed for each measurand per sample by site."},{"outcome_type":"primary","measure":"Sample Matrix Comparison","time_frame":"3 months","description":"Paird capillary and venous whole blood samples will be collected. The samples will be analyzed in duplicate on the Sight OLO device. Analysis will include Passing-Bablok Regression analysis per parameter (Bland Altman plots, slope, intercept, with 95% confidence intervals, correlation coefficient, and % bias), between: The average of venous whole blood samples scans and average of capillary whole blood sample scans from the same individual on the Sight OLO device"},{"outcome_type":"primary","measure":"Method Comparison","time_frame":"3 months","description":"Evaluate the performance of the OLO device in comparison to values achieved with the predicate. Analysis will include Regression parameters (slope, intercept with 95% CI) between measurement of Sight OLO and measurement on predicate (Correlation coefficient, Bland Altman plots and overall % bias between predicate and Sight OLO device including % bias at medical decision points)."},{"outcome_type":"primary","measure":"Reference Interval Range","time_frame":"3 months","description":"Establish adult venous and fingerprick reference intervals for the OLO device. The non-parametric method will be used to calculate the lower and upper limits of the reference range."}]}
{"nct_id":"NCT03241485","start_date":"2018-06-19","phase":"Phase 4","enrollment":79,"brief_title":"Trial Comparing Intrathecal Morphine With Placebo In Patients Undergoing Robotic Cardiac Surgery","official_title":"Randomized, Double Blinded, Trial Comparing Intrathecal Morphine With Placebo in Patients Undergoing Robotic Totally Endoscopic Beating Heart Coronary Revascularization and Intraoperative Extubation","primary_completion_date":"2020-09-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-09-01","last_update":"2021-01-25","description":"This is a randomized clinical trial in patients undergoing robotic myocardial revascularization with intraoperative extubation. Patients will be randomized into placebo or intrathecal morphine groups to assess postoperative pain scores and patient satisfaction. Patients will also be assessed for side effects from the intervention.","other_id":"IRB17-1103","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","intervention_model_description":"The patients will be randomized into 2 groups. The placebo group will receive intrathecal saline. The morphine group will receive intrathecal morphine.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n         patient undergoing elective robotic myocardial revascularization without anticipated use\r\n        of cardiopulmonary bypass and with anticipated intraoperative tracheal extubation.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Emergency surgery\r\n\r\n          -  Preoperative use of inotropes/IABP\r\n\r\n          -  Preoperative use of opoids\r\n\r\n          -  Ejection fraction less than 40%\r\n\r\n          -  Anticipated use of cardiopulmonary bypass\r\n\r\n          -  Previous cardiothoracic surgery\r\n\r\n          -  Anticipated postoperative tracheal intubation\r\n\r\n          -  severe pulmonary disease\r\n\r\n          -  morbid obesity (BMI >35 kg/m2)\r\n\r\n          -  severe hepatic impairment\r\n\r\n          -  severe renal dysfunction (creatinine > 1.5)\r\n\r\n          -  any contraindication to intrathecal injection (patient refusal, difficult patient\r\n             anatomy, pre-existing coagulopathy, morphine allergy)\r\n      ","sponsor":"University of Chicago","sponsor_type":"Other","conditions":"Pain","interventions":[{"intervention_type":"Drug","name":"Drug: Intrathecal morphine","description":"5 micrograms/kilogram of intrathecal morphine administered in the spinal space, not to exceed 1mg"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Saline intrathecal given in the same manner as the intervention groups."}],"outcomes":[{"outcome_type":"primary","measure":"Postoperative morphine consumption","time_frame":"24 hours after surgery","description":"We anticipate that patients in the intervention groups will require less postoperative morphine for pain control."},{"outcome_type":"secondary","measure":"Pain Score","time_frame":"First 48 hours after surgery","description":"Patients will score their pain on a visual analog scale of 0-10"},{"outcome_type":"secondary","measure":"Patient Satisfaction","time_frame":"2-3 days after surgery, prior to discharge.","description":"Patients will take a satisfaction survey prior to discharge."},{"outcome_type":"secondary","measure":"Adverse effects","time_frame":"Until discharge, 2-3 days after surgery","description":"adverse effects such as itching, nausea/vomiting, respiratory depression and sedation"},{"outcome_type":"secondary","measure":"Cardiac arrhythmia/cardiac event","time_frame":"24 hours after surgery","description":"Postoperative EKG will be obtained in all patients."},{"outcome_type":"secondary","measure":"Pulmonary complication","time_frame":"During hospital stay","description":"Pneumonia or reintubation"}]}
{"nct_id":"NCT03705130","start_date":"2018-06-14","enrollment":26,"brief_title":"Evaluation of Visual Performance With Contact Lenses","official_title":"Evaluation of Visual Performance With Contact Lenses","primary_completion_date":"2018-07-26","study_type":"Observational","rec_status":"Completed","completion_date":"2018-07-26","last_update":"2018-10-15","description":"This study will evaluate the influence of contact lens optical design on visual performance using standard and multifocal soft contact lenses (MFCLs).","other_id":"STUDY00000958","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":39,"population":"Subjects between the ages of 18-39 (inclusive) without significant ocular disease.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18 to 39 years of age\r\n\r\n          -  Best corrected visual acuity of at least 20/30\r\n\r\n          -  Spherical equivalent refractive error in each eye of between -0.75 and -6.00 diopters\r\n             sphere after vertexing to the corneal plane\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Greater than -1.00 diopter of refractive astigmatism at the corneal plane\r\n\r\n          -  Any active anterior segment disease, pathology, or surgery affecting vision,\r\n             refraction, or the ability to wear a soft contact lens\r\n\r\n          -  History of ocular trauma or surgery causing abnormal or distorted vision\r\n\r\n          -  Current Rigid Gas Permeable (RGP) contact lens wearers\r\n\r\n          -  Unwilling to have eyes photographed or video recorded\r\n\r\n          -  Pregnant and/or lactating females, by self-report\r\n      ","sponsor":"University of Houston","sponsor_type":"Other","conditions":"Myopia","interventions":[{"intervention_type":"Device","name":"Device: Single Vision Contact Lens","description":"Spherical Contact Lens worn on non-dispensing basis"},{"intervention_type":"Device","name":"Device: Multifocal Contact Lens 1","description":"Multifocal Contact Lens worn on non-dispensing basis"},{"intervention_type":"Device","name":"Device: Multifocal Contact Lens 2","description":"Multifocal Contact Lens worn on non-dispensing basis"}],"outcomes":[{"outcome_type":"primary","measure":"Low Contrast Visual Acuity with Glare","time_frame":"Through study completion, an average of 3 hours","description":"Vision with contact lenses measured under low illumination conditions with glare source"},{"outcome_type":"secondary","measure":"Low Contrast Visual Acuity without Glare","time_frame":"Through study completion, an average of 3 hours","description":"Vision with contact lenses measured under low illumination conditions without glare source"}]}
{"nct_id":"NCT03562117","start_date":"2018-06-14","phase":"Phase 1","enrollment":25,"brief_title":"Pharmacokinetics (PK) Study of Gepotidacin (GSK2140944) in Adult Subjects With Varying Degrees of Hepatic Impairment and in Matched Control Subjects With Normal Hepatic Function","official_title":"A Phase I, Open-Label, Single-Dose, Two-Part Study to Assess the Pharmacokinetics of Gepotidacin (GSK2140944) in Male and Female Adult Participants With Varying Degrees of Hepatic Impairment and in Matched Control Participants With Normal Hepatic Function","primary_completion_date":"2018-12-26","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-12-26","last_update":"2021-04-12","description":"This is a two-part study which will evaluate the PK, safety, and tolerability of a single 1500 milligram (mg) oral dose of gepotidacin in subjects with normal hepatic function and in subjects with mild, moderate, and severe hepatic impairment. In Part 1, subjects with moderate hepatic impairment and subjects with normal hepatic function will be enrolled. Matching subjects with normal hepatic function in Part 1 (Group D), will be enrolled following the completion of all Day 3 assessments of the respective matched, hepatically impaired subject. In Part 2, subjects with mild (optional) and severe hepatic impairment and subjects with normal hepatic function will be enrolled concurrently based on the PK, safety, and tolerability data of Part 1. Subjects with mild hepatic impairment, may be studied if there is a significant difference in PK between subjects with moderate hepatic impairment and subjects with normal hepatic function. Subjects with severe hepatic impairment, will be studied in Part 2, provided that, the PK objectives are achieved in Part 1. A totals of 48 subjects, are planned to be enrolled in the study. The study duration is approximately of 44 days from Screening to Follow-up visit. The results from this study will enable the development of appropriate dosing recommendations in subjects with impaired hepatic function.","other_id":"117352","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subjects must be 18 to 80 years of age inclusive, at the time of signing the informed\r\n             consent.\r\n\r\n          -  Healthy subjects must be in clinically stable health as determined by the investigator\r\n             based on medical history, clinical laboratory results (serum chemistry, hematology,\r\n             urinalysis, and serology), vital sign measurements, 12-lead ECG results, and physical\r\n             examination findings.\r\n\r\n          -  Hepatically impaired subjects must have chronic (>6 months), stable (no acute episodes\r\n             of illness within the previous 1 month prior to screening due to deterioration in\r\n             hepatic function) hepatic insufficiency with features of cirrhosis due to any\r\n             etiology. Subjects must also remain stable throughout the Screening period.\r\n\r\n          -  Hepatically impaired subjects, will be classified, using the Child-Pugh classification\r\n             system. Subjects must have, a Child-Pugh score, of 5 to 6 (mild hepatic impairment), 7\r\n             to 9 (moderate hepatic impairment), or 10 to 15 (severe hepatic impairment), with\r\n             known medical history of liver disease (with or without a known history of alcohol\r\n             abuse), and previous confirmation of liver cirrhosis by liver biopsy or other medical\r\n             imaging technique (including laparoscopy, computed tomography scan, magnetic resonance\r\n             imaging, or ultrasonography) associated with unambiguous medical history. If imaging\r\n             study, or biopsy is not available, then the subject should have one of the following:\r\n             Physical findings such as hepatomegaly, ascites, palmar erythema, spider angiomata,\r\n             abdominal venous collaterals, gynecomastia, or other physical manifestations of\r\n             hepatic disease Or Laboratory findings: ALT or AST elevation (> upper limit of normal\r\n             [ULN]), alkaline phosphatase, or total bilirubin, or international normalized ratio\r\n             (INR) elevation (>ULN) or an albumin value that is below the lower limit of normal\r\n             laboratory reference range.\r\n\r\n          -  Subjects with hepatic impairment may be taking medications, which in the opinion of\r\n             the investigator, are believed to be therapeutic, and these medications should not\r\n             interfere with the conduct of the study. Subjects with hepatic impairment should be on\r\n             stable regimen of chronic medications for at least 7 days prior to dosing until\r\n             completion of the Follow-Up Visit.\r\n\r\n          -  Subjects with hepatic impairment must have platelet counts of 30,000  109/Liter of\r\n             blood and have not had any major bleeding episodes within the past 6 months.\r\n\r\n          -  Body weight >=45 kilogram (kg) and body mass index (BMI) within the range 18.5 to 40\r\n             kg/meter^2 (inclusive).\r\n\r\n          -  Male subjects must agree to use contraception, as protocol from Day -1 until\r\n             completion of the Follow-up Visit or, female subject will be eligible to participate\r\n             if she is not pregnant not breastfeeding, and at least one of the following conditions\r\n             applied Not a woman of childbearing potential (WOCBP) or A WOCBP who agrees to follow\r\n             the contraceptive guidance from 30 days prior to study drug administration and until\r\n             completion of the Follow-up Visit.\r\n\r\n          -  Capable of giving signed informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subject has a clinically significant abnormality in past medical history or at the\r\n             Screening physical examination (excluding hepatic insufficiency and other related\r\n             medical conditions within the hepatically impaired populations, which should be stable\r\n             for at least 1 month before study drug administration), that in the investigator's\r\n             opinion, may place the subject at risk or interfere with outcome variables of the\r\n             study. This includes, but is not limited to, history or current significant cardiac,\r\n             renal, neurologic, gastrointestinal, respiratory, hematologic, or immunologic disease.\r\n\r\n          -  Subject has any surgical or medical condition (active or chronic) that may interfere\r\n             with drug absorption, distribution, metabolism, or excretion of the study drug, or any\r\n             other condition that may place the subject at risk, in the opinion of the\r\n             investigator.\r\n\r\n          -  Female subject, has a positive pregnancy test result or is lactating at Screening or\r\n             upon admission to the clinic.\r\n\r\n          -  Subject has used a systemic antibiotic within 7 days of Screening.\r\n\r\n          -  Subject has a confirmed history of Clostridium (C) difficile infection or a positive\r\n             C. difficile toxin test, within 2 months before Screening.\r\n\r\n          -  Subject has a history of drug and/or alcohol abuse within 6 months before Screening,\r\n             as determined by the investigator, or subject has a positive drug screen at Screening\r\n             or upon admission to the clinic. For subjects with hepatic impairment, and a positive\r\n             drug screen result related to the use of prescription medications, is allowed per\r\n             investigator review and approval, and tetrahydrocannabinol use is allowed per\r\n             investigator review and approval.\r\n\r\n          -  History of sensitivity to any of the study drugs, components thereof, or a history of\r\n             drug or other allergy that, in the opinion of the investigator or GSK medical monitor,\r\n             contraindicates their participation.\r\n\r\n          -  History of sensitivity to heparin or heparin-induced thrombocytopenia (if the clinic\r\n             uses heparin to maintain intravenous cannula patency).\r\n\r\n          -  Subject has used medications known to affect the elimination of serum creatinine\r\n             (example (e.g); trimethoprim or cimetidine) or competitors of renal tubular secretion\r\n             (e.g., probenecid) within 30 days before dosing.\r\n\r\n          -  Subject must abstain from taking prescription or nonprescription drugs (including\r\n             vitamins and dietary or herbal supplements), unless specified, within 7 days (or 14\r\n             days if the drug is a potential strong enzyme inducer) or 5 half-lives (whichever is\r\n             longer) prior to study drug administration until completion of the Follow-Up Visit,\r\n             unless, in the opinion of the investigator and Sponsor, the medication will not\r\n             interfere with the study. Any exceptions (including subjects with hepatic impairment\r\n             that will be on medications during the study), will be discussed with the sponsor or\r\n             medical monitor on a case-by-case basis and the reasons will be documented.\r\n\r\n          -  Previous exposure to gepotidacin, within 12 months prior to study drug administration.\r\n\r\n          -  Subject has participated in a clinical trial and has received an investigational\r\n             product within the following time period prior to study drug administration in the\r\n             current study: 30 days, 5 half-lives, or twice the duration of the biological effect\r\n             of the investigational product (whichever is longer).\r\n\r\n          -  Subject with normal hepatic function has presence of hepatitis B surface antigen or\r\n             positive hepatitis C antibody test result at Screening or within 3 months prior to\r\n             study drug administration. Subject with hepatic impairment has evidence of recent,\r\n             acute infection with hepatitis B and/or hepatitis C within preceding 6 months.\r\n             Hepatically impaired subjects with chronic hepatitis B or C (duration >6 months) will\r\n             be eligible for enrolment.\r\n\r\n          -  A positive test for human immunodeficiency virus antibody.\r\n\r\n          -  Subject must be able to abstain from alcohol and limit use of nicotine and/or\r\n             nicotine-containing products (up to 5 cigarettes/day is acceptable for subjects with\r\n             hepatic impairment) for 24 hours before the start of dosing until after collection of\r\n             the final PK sample. A positive alcohol or cotinine test is not exclusionary for\r\n             subjects with hepatic impairment.\r\n\r\n          -  Subject has clinically significant abnormal findings in serum chemistry, hematology,\r\n             or urinalysis results obtained at Screening or Day -1, other than those associated\r\n             with underlying hepatic conditions or other stable medical conditions consistent with\r\n             the disease process in subjects with hepatic impairment.\r\n\r\n          -  Subject with normal hepatic function has a baseline corrected QT interval using the\r\n             Fridericia formula (QTcF) of >450 milliseconds (msec) and subject with hepatic\r\n             impairment has a baseline QTcF of >480 msec.\r\n\r\n          -  Donation of blood in excess of 500 milliliter (mL) within 12 weeks prior to dosing or\r\n             participation in the study would result in donation of blood or blood products in\r\n             excess of 500 mL within a 56-day period.\r\n\r\n          -  Subject is unable to comply with all study procedures, in the opinion of the\r\n             investigator.\r\n\r\n          -  Subject should not participate in the study, in the opinion of the investigator or\r\n             Sponsor.\r\n\r\n          -  Subjects with a pre-existing condition (except hepatic impairment) interfering with\r\n             normal gastrointestinal (GI) anatomy or motility that could interfere with the\r\n             absorption, metabolism, and/or excretion of the study drugs. Subjects with a history\r\n             of inflammatory bowel disease should be excluded. Subjects with a history of\r\n             pepticulceration or pancreatitis within the preceding 6 months of screening, should be\r\n             excluded.\r\n\r\n          -  Subject with any previous GI surgery (except appendectomy or gall bladder removal >3\r\n             months prior to Screening) may be enrolled in this study only if, in the opinion of\r\n             the investigator and the medical monitor, it is not expected to interfere with the\r\n             study procedures or to pose an additional safety risk to the subject.\r\n\r\n          -  Subject receiving lactulose who are medically unable to halt lactulose administration\r\n             from 8 hours before dosing with study drug to 4 hours after dosing with study drug.\r\n\r\n          -  Subjects with clinically active severe encephalopathy (grade 3 or 4) as judged by the\r\n             investigator or significant central nervous system disease (e.g., dementia or\r\n             seizures) which the investigator considers will interfere with the informed consent,\r\n             conduct, completion, or results of this trial or constitutes an unacceptable risk to\r\n             the subject. Subjects with a prior history of severe encephalopathy, who are currently\r\n             treated for this condition will receive the appropriate score for encephalopathy.\r\n\r\n          -  Subjects with estimated creatinine clearance (Clcr) <=50 mL/minute (calculated by the\r\n             Cockcroft-Gault Formula). If the result calculated by Cockcroft-Gault is between 40\r\n             and 50 mL/minute, then the site may complete a 24-hour urine collection to more\r\n             specifically calculate the Clcr. A Clcr value <=50 mL/minute via 24-hour urine\r\n             collection is also exclusionary.\r\n\r\n          -  History of gastric or esophageal variceal bleeding within the past 6 months and for\r\n             which varices have not been adequately treated with medication and/or surgical\r\n             procedures.\r\n\r\n          -  Subjects with electrolyte imbalance whose serum sodium levels are <=125 millimole per\r\n             Liter (mmol/L); potassium levels are <=2.5 mmol/L; or calcium levels are <=6.1 mmol/L.\r\n\r\n          -  Presence of hepatopulmonary or hepatorenal syndrome.\r\n\r\n          -  Primary cholestatic liver diseases.\r\n\r\n          -  History of liver transplantation or subjects in the severe hepatic impairment group\r\n             that are expecting a liver transplant during the study participation period.\r\n\r\n          -  Subjects with signs of active bacterial infection (including active spontaneous\r\n             bacterial peritonitis).\r\n\r\n          -  Subjects with transjugular intrahepatic portosystemic shunt placement within the past\r\n             3 months.\r\n\r\n          -  Subjects with unstable cardiac function or subjects with hypertension whose blood\r\n             pressure, that is not well controlled (based on the investigator's discretion).\r\n\r\n          -  Diabetic subjects whose diabetes that is not controlled (based on the investigator's\r\n             discretion).\r\n      ","sponsor":"GlaxoSmithKline","sponsor_type":"Industry","conditions":"Infections, Bacterial","interventions":[{"intervention_type":"Drug","name":"Drug: Gepotidacin","description":"It is an immediate-release tablet (1500 mg (2 x 750 mg), containing gepotidacin (free base) an inactive formulation excipients."}],"outcomes":[{"outcome_type":"primary","measure":"Area Under the Plasma Concentration-time Curve (AUC) From Time Zero (Pre-dose) Extrapolated to Infinity (AUC[0-inf]) for Plasma Gepotidacin","time_frame":"Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose","description":"Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate pharmacokinetic (PK) parameters. PK parameter population consist of all participants in the PK Population, for whom valid and evaluable PK parameters were derived. This population was used in the assessment and characterization of PK parameters."},{"outcome_type":"primary","measure":"Maximum Observed Concentration (Cmax) for Plasma Gepotidacin","time_frame":"Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose","description":"Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters."},{"outcome_type":"secondary","measure":"AUC From Time 0 to the Time of the Last Quantifiable Concentration (AUC [0-t]) for Plasma Gepotidacin","time_frame":"Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose","description":"Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters."},{"outcome_type":"secondary","measure":"Time to First Occurrence (Tmax) of Cmax for Plasma Gepotidacin","time_frame":"Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose","description":"Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters."},{"outcome_type":"secondary","measure":"Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) for Plasma Gepotidacin","time_frame":"Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose","description":"Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters."},{"outcome_type":"secondary","measure":"Apparent Oral Clearance (CL/F) for Plasma Gepotidacin","time_frame":"Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose","description":"Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters."},{"outcome_type":"secondary","measure":"Apparent Volume of Distribution of the Terminal Phase (Vz/F) for Plasma Gepotidacin","time_frame":"Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose","description":"Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters."},{"outcome_type":"secondary","measure":"Terminal-phase Rate Constant (Lambda_z) for Plasma Gepotidacin","time_frame":"Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose","description":"Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters."},{"outcome_type":"secondary","measure":"Terminal Phase Half Life (t1/2) for Plasma Gepotidacin","time_frame":"Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose","description":"Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters."},{"outcome_type":"secondary","measure":"Number of Participants With Abnormal Electrocardiogram (ECG) Findings","time_frame":"1.5 hours, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, and 48 hours post-dose","description":"Single 12-lead ECG was obtained in a semi-supine position after 5 minutes rest using an ECG machine. Safety Population consists of all participants who received at least 1 dose of study drug and had at least one postdose safety assessment. Number of participants with abnormal-clinically significant and abnormal-not clinically significant values has been presented. Absolute QTc Interval >450 milliseconds (msec), absolute PR interval <110 msec and absolute QRS interval <75 msec was considered as clinically significant ECG findings."},{"outcome_type":"secondary","measure":"Change From Baseline Values in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)","time_frame":"Baseline (Day 1) and at 1.5 hours, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, and 48 hours post-dose","description":"Vital signs were measured in a semi-supine position after 5 minutes rest. Baseline is defined as Day 1 (Pre-Dose). Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value."},{"outcome_type":"secondary","measure":"Change From Baseline Values in Heart Rate","time_frame":"Baseline (Day 1) and at 1.5 hours, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, and 48 hours post dose","description":"Vital signs was measured in a semi-supine position after 5 minutes rest. Baseline is defined as Day 1 (Pre-Dose). Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value."},{"outcome_type":"secondary","measure":"Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs","time_frame":"Up to Day 15","description":"An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgment."},{"outcome_type":"secondary","measure":"Number of Participants With Toxicity Grading 3 or Higher for Clinical Chemistry Parameters","time_frame":"Up to Day 15","description":"Blood samples were collected to measure the number of participants with toxicity grades higher than 3 or 4, for urea, Creatine kinase (CK), creatinine, glucose, sodium, potassium, calcium, Aspartate Aminotransferase, (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) levels, total and direct bilirubin, total protein, and albumin."},{"outcome_type":"secondary","measure":"Change From Baseline Values for Clinical Chemistry Parameters: ALT, ALP, AST and CK","time_frame":"Baseline and at Day 2","description":"Blood samples were collected to analyze clinical chemistry parameters including: ALT, ALP, AST and CK. Baseline is defined as Day 1 (Pre-Dose). Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value."},{"outcome_type":"secondary","measure":"Change From Baseline Values for Clinical Chemistry Parameters: Albumin and Protein","time_frame":"Baseline and at Day 2","description":"Blood samples were collected to analyze clinical chemistry parameters including albumin and protein. Baseline is defined as Day 1 (Pre-Dose). Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value."},{"outcome_type":"secondary","measure":"Change From Baseline Values for Clinical Chemistry Parameters: Bilirubin, Direct Bilirubin and Creatinine","time_frame":"Baseline and at Day 2","description":"Blood samples were collected to analyze clinical chemistry parameters including bilirubin, direct bilirubin and creatinine. Baseline is defined as Day 1 (Pre-Dose). Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value."},{"outcome_type":"secondary","measure":"Change From Baseline Values for Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Urea","time_frame":"Baseline and at Day 2","description":"Blood samples were collected to analyze clinical chemistry parameters including calcium, glucose, potassium, sodium and urea. Baseline is defined as Day 1 (Pre-Dose). Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value."},{"outcome_type":"secondary","measure":"Number of Participants With Toxicity Grading 3 or Higher for Hematology Parameters","time_frame":"Up to 15 days","description":"Blood samples were collected to measure the number of participants with toxicity grades higher than 3 or 4 for blood neurtophils and blood platelets."},{"outcome_type":"secondary","measure":"Number of Participants With Toxicity Grading 3 or Higher for Urinalysis Parameters","time_frame":"Up to 15 days","description":"Urine samples were collected and specific gravity, potential of hydrogen (pH), glucose, protein, blood and ketones were analyzed by dipstick method."},{"outcome_type":"secondary","measure":"Number of Participants With Abnormal Findings During Physical Examinations","time_frame":"Pre-dose up to 31 days prior to dosing","description":"A complete physical examination included, at a minimum, assessments of the skin, cardiovascular, respiratory, gastrointestinal and neurological systems. Height and weight were also measured and recorded. A brief physical examination included, at a minimum, assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). This analysis was planned but data was not captured in the database. Abnormal changes were captured as adverse events if they were clinically significant."},{"outcome_type":"secondary","measure":"Total Unchanged Drug (Ae_total) and Amount of Drug Excreted in Urine in a Time Intervals (Ae (t1-t2) for Gepotidacin","time_frame":"Pre-dose, 0-2 hours, 2-4 hours, 4-6 hours, 6-8 hours, 8-12 hours, 12-24 hours, 24-36 hours and 36-48 hours post-dose","description":"Urine samples were collected from participants at indicated time points. Ae_total was calculated by adding all the fractions of drug collected over all the allotted time intervals. Ae (t1-t2) was the amount of drug excreted in urine in time intervals for predose, 0 to 6, 6 to 12, 12 to 24, 24 to 36, and 36 to 48 hours after dosing for participants with hepatic impairment; and predose, 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours for participants with normal hepatic function. It was calculated by multiplication of the urine concentration for a time interval and the length of this time interval."},{"outcome_type":"secondary","measure":"Percentage of the Given Dose of Drug Excreted in Urine (Fe%)","time_frame":"Pre-dose, 0-2 hours, 2-4 hours, 4-6 hours, 6-8 hours, 8-12 hours, 12-24 hours, 24-36 hours and 36-48 hours post-dose","description":"Urine samples were collected from participants at indicated time points. Percentage of the given dose of drug excreted in urine was calculated as: (Ae_total divided by Dose) and multiplied by 100."},{"outcome_type":"secondary","measure":"Renal Clearance (CLr) of Gepotidacin","time_frame":"Pre-dose, 0-2 hours, 2-4 hours, 4-6 hours, 6-8 hours, 8-12 hours, 12-24 hours, 24-36 hours and 36-48 hours post-dose","description":"Urine samples were collected from participants at indicated time points. Renal clearance for gepotidacin was calculated as Ae_total divided by AUC (0-t)."},{"outcome_type":"secondary","measure":"AUC(0-12) of Gepotidacin","time_frame":"Pre-dose, 0-2 hours, 2-4 hours, 4-6 hours, 6-8 hours and 8-12 hours post dose","description":"Urine samples were collected from participants at indicated time points to evaluate AUC(0-12) PK parameter of gepotidacin."},{"outcome_type":"secondary","measure":"AUC(0-24) of Gepotidacin","time_frame":"Pre-dose, 0-2 hours, 2-4 hours, 4-6 hours, 6-8 hours, 8-12 hours and 12-24 hours post dose","description":"Urine samples were collected from participants at indicated time points to evaluate AUC(0-24) PK parameter of gepotidacin."},{"outcome_type":"secondary","measure":"AUC(0-48) of Gepotidacin","time_frame":"Pre-dose, 0-2 hours, 2-4 hours, 4-6 hours, 6-8 hours, 8-12 hours, 12-24 hours, 24-36 hours and 36-48 hours post dose","description":"Urine samples were collected from participants at indicated time points to evaluate AUC(0-48) PK parameter of gepotidacin."}]}
{"nct_id":"NCT03562468","start_date":"2018-06-13","phase":"N/A","enrollment":40,"brief_title":"A Study by ChromaDex to Assess the Effects of TRU NIAGEN on Cognitive Function, Mood and Sleep in Older Adults","official_title":"A Randomized, Double-Blind, Crossover Study to Assess the Effects of Nicotinamide Riboside on Cognitive Function, Mood and Sleep in Older Adult Men and Women","primary_completion_date":"2019-04-26","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-04-26","last_update":"2019-07-24","description":"The sponsor of this study is ChromaDex, Inc. This is a double-blind, randomized, crossover study to investigate the effects of 300 mg/d and 1000 mg/d TRU NIAGEN (nicotinamide riboside) compared to a placebo control on cognitive function, mood and sleep in men and women over 55 years of age. The trial is managed by Midwest Center for Metabolic and Cardiovascular Research.","other_id":"MB-1801","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Other","masking_description":"Quadruple","intervention_model_description":"Treatments will be administered daily as 4 capsules in a double-blind, randomized, crossover manner for three 8-week treatment periods. Each subject will receive one placebo and two active treatments in a crossover design.","sampling_method":"","gender":"All","minimum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Subject is male or female, 55 years of age.\r\n\r\n          2. Subject has a BMI of 18.50 to 34.99 kg/m2.\r\n\r\n          3. Subject has a score of 80 on executive function at screening. One re-test will be\r\n             allowed for subjects who require additional instruction on the CNS VS test battery.\r\n\r\n          4. Subject is willing to maintain usual diet and physical activity patterns.\r\n\r\n          5. Subject has no plans to change smoking habits during the study period.\r\n\r\n          6. Subject is willing to limit alcohol consumption to no more than one serving of alcohol\r\n             per day (1 drink = 12 oz beer, 5 oz wine, or 1.5 oz hard liquor) and will abstain from\r\n             consuming 2 h prior to retiring for the evening for the duration of the study.\r\n\r\n          7. Subject is willing to limit consumption of caffeine-containing\r\n             beverages/foods/products to no more than 400 mg daily, with all caffeine consumption\r\n             occurring prior to 6 pm.\r\n\r\n          8. Subject is willing to fast (8 - 15 h, target 10 h, water only) prior to each clinic\r\n             visit.\r\n\r\n          9. Subject has no difficulties swallowing capsules.\r\n\r\n         10. Subject is willing and able to attend all clinic visits.\r\n\r\n         11. Subject understands the study procedures and signs forms documenting informed consent\r\n             to participate in the study and authorization for release of relevant protected health\r\n             information to the study Investigator and is willing to complete study procedures.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Individual has history or presence of a clinically significant (in the opinion of the\r\n             Investigator) psychiatric disorder or neurologic disease including epilepsy,\r\n             cerebrovascular disturbance or traumatic injury.\r\n\r\n          2. Individual has a history of diagnosed clinical depression in the prior 2 years, or a\r\n             score 20 (defined as moderate-to-severe depression) on the Beck Depression\r\n             Inventory-II administered at visit 1 (week -1).\r\n\r\n          3. Individual is currently diagnosed with dementia and/or has a score <24 on the Mini\r\n             Mental State Questionnaire administered at visit 1 (week -1).\r\n\r\n          4. Uncorrected abnormal vision that in the opinion of the Investigator would impair the\r\n             subject's ability to complete the computerized testing (including but not limited to\r\n             nearsightedness, farsightedness, and color blindness).\r\n\r\n          5. Individual has a clinically important active endocrine, cardiovascular, renal,\r\n             hepatic, pulmonary, pancreatic, neurologic or biliary disorder.\r\n\r\n          6. Individual has a history of a cardiovascular event or revascularization procedure\r\n             within 6 months of visit 1 (week -1).\r\n\r\n          7. Individual has a diagnosis of type I diabetes mellitus. Type 2 diabetes mellitus is\r\n             excluded if the individual has experienced initiation of or a dosage change in\r\n             diabetes medication(s) within 2 months of visit 1 (week -1), or has significant\r\n             co-morbidities as determined by the study physician.\r\n\r\n          8. Insulin for the treatment of Type I or Type 2 diabetes mellitus is exclusionary.\r\n\r\n          9. Individual has uncontrolled hypertension (systolic blood pressure 160 mm Hg and/or\r\n             diastolic blood pressure 100 mm Hg).\r\n\r\n         10. Individual has a recent history (prior 5 years) or the presence of cancer other than\r\n             non-melanoma skin cancer.\r\n\r\n         11. Individual has a history or presence of a chronic pain condition requiring regular use\r\n             of opioid therapy.\r\n\r\n         12. Individual has a recent history or strong potential for drug or alcohol abuse defined\r\n             as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1  oz distilled spirits).\r\n\r\n         13. Individual has a history of unconventional sleep patterns (e.g., night shift) or\r\n             chronic insomnia (at least 3 d/week over the past month), a diagnosed sleep disorder,\r\n             or a chronic medical condition with the potential to impact energy/fatigue levels.\r\n\r\n         14. Individuals taking any form of niacin >25 mg/d and any use of nicotinamide riboside\r\n             within 2 weeks of visit 1 (week -1).\r\n\r\n         15. Individual is a heavy consumer of caffeinated beverages (>400 mg/d within 2 weeks of\r\n             visit 1).\r\n\r\n         16. Individual has a history of using psychotropic medications (including antidepressants\r\n             and tranquilizers), stimulant medications, and/or narcotics within 4 weeks of visit 1\r\n             (week -1).\r\n\r\n         17. Individual has used sleep aid medications, supplements, and/or products, including\r\n             antihistamines, within 2 weeks of visit 1 (week -1) A washout prior to screening is\r\n             allowed).\r\n\r\n         18. Individual has a known allergy to any ingredients in the study products.\r\n\r\n         19. Individual is pregnant, planning to be pregnant during the study period, lactating, or\r\n             is of childbearing potential and is unwilling to commit to use of a medically approved\r\n             form of contraception throughout the study period.\r\n\r\n         20. Subject has an active infection or has used antibiotics within 5 d of any clinic\r\n             visit. For those with an active infection and/or using antibiotics, subjects must wait\r\n             at least 5 d after the infection resolves or antibiotic use is complete. The test\r\n             period will be extended for completion in these cases.\r\n\r\n         21. Subject has been exposed to any non-registered drug product within 30 d of visit 1\r\n             (week -1).\r\n\r\n         22. Individual has a condition the Investigator believes would interfere with his or her\r\n             ability to provide informed consent, comply with the study protocol, which might\r\n             confound the interpretation of the study results or put the person at undue risk.\r\n      ","sponsor":"ChromaDex, Inc.","sponsor_type":"Industry","conditions":"Cognitive Function|Mood|Sleep","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: 300 mg/day of TRU NIAGEN (nicotinamide riboside)","description":"Treatment with 300 mg/day of TRU NIAGEN (nicotinamide riboside) will be administered daily as 4 capsules in a double-blind, randomized, crossover manner for three 8-week treatment periods. Each subject will receive one placebo and two active treatments in a crossover design. The two active treatments are 300 mg/d TRU NIAGEN (nicotinamide riboside) and 1000 mg/d TRU NIAGEN (nicotinamide riboside)."},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: 1000 mg/day of TRU NIAGEN (nicotinamide riboside)","description":"Treatment 1000 mg/day of TRU NIAGEN (nicotinamide riboside) will be administered daily as 4 capsules in a double-blind, randomized, crossover manner for three 8-week treatment periods. Each subject will receive one placebo and two active treatments in a crossover design. The two active treatments are 300 mg/d TRU NIAGEN (nicotinamide riboside) and 1000 mg/d TRU NIAGEN (nicotinamide riboside)."},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Placebo","description":"Treatment with placebo capsules will be administered daily as 4 capsules in a double-blind, randomized, crossover manner for three 8-week treatment periods. Each subject will receive one placebo and two active treatments in a crossover design. The two active treatments are 300 mg/d TRU NIAGEN (nicotinamide riboside) and 1000 mg/d TRU NIAGEN (nicotinamide riboside)."}],"outcomes":[{"outcome_type":"primary","measure":"The primary comparison will be the low dose (300 mg/d nicotinamide riboside) condition to the placebo condition for the change from baseline to the end of each relevant treatment period.","time_frame":"8 weeks","description":"The primary outcome variable will be the difference between treatments in the change from baseline (defined as visit 2 value for each of the three treatment periods) in executive function measured with the CNS Vital Signs test battery, using the standard score."}]}
{"nct_id":"NCT03493841","start_date":"2018-06-08","phase":"Phase 1","enrollment":20,"brief_title":"Comparing Tolerability and Absorption of Racemic and R-lipoic Acid in Progressive Multiple Sclerosis","official_title":"Comparing Gastrointestinal Tolerability and Absorption of Racemic Lipoic Acid and R-lipoic Acid in Progressive Multiple Sclerosis: a Randomized Crossover Trial","primary_completion_date":"2019-01-25","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-01-25","last_update":"2019-03-22","description":"This is a three-week crossover study that will compare how the body absorbs and tolerates two different forms of lipoic acid: R form and racemic form.","other_id":"IRB #17951","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosis of Progressive Multiple Sclerosis\r\n\r\n          -  18 years of age or older\r\n\r\n          -  Able to give informed consent and adhere to the study activities\r\n\r\n          -  Able to swallow large oral capsules\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Clinical Multiple Sclerosis relapse in the prior 1 year\r\n\r\n          -  Oral or IV steroids in the prior 3 months\r\n\r\n          -  Have taken LA in last 30 days\r\n\r\n          -  Clinically significant kidney disease as determined by the PI including, but not\r\n             limited to, major kidney disease diagnoses, abnormal laboratory values related to\r\n             renal function, or other related conditions\r\n\r\n          -  Insulin-dependent diabetes\r\n\r\n          -  Other significant ongoing medical illness that may interfere with study procedures\r\n\r\n          -  Taking oral anticoagulants (e.g. Coumadin). Aspirin, clopidogrel, and dipyridamole are\r\n             acceptable to take\r\n\r\n          -  Pregnant or breast-feeding\r\n\r\n          -  Any condition which would make the patient, in the opinion of the investigator,\r\n             unsuitable for the study\r\n      ","sponsor":"Rebecca Spain","sponsor_type":"Other","conditions":"Multiple Sclerosis|Progressive Multiple Sclerosis|Secondary Progressive Multiple Sclerosis|Primary Progressive Multiple Sclerosis","interventions":[{"intervention_type":"Drug","name":"Drug: Alpha Lipoic Acid","description":"Lipoic acid is an over the counter supplement. Two different forms, R and racemic are available. R-lipoic acid is the naturally occurring form. Racemic lipoic acid is the most commonly available supplement."}],"outcomes":[{"outcome_type":"primary","measure":"Comparison of oral tolerance between R-LA and racemic LA","time_frame":"Obtained at first (Visits 1 and 3) and last doses (visits 2 and 4) of each form of LA. Each visit is approximately a week apart.","description":"Oral tolerance will be determined by the completion of a modified Monitoring of Side Effects Scale at each study visit. This scale asks the participant to rate the following side effects: abdominal pain, appetite: decreased, appetite: increased, constipation, diarrhea, flatulence, nausea/vomiting, taste abnormality (metallic, etc.), thirst: increased, thirst: decreased, and weight: increased. Each side effect will be rated on severity. 0 - the lowest possible score represents \"not present\". 4 - the highest possible score represents \"severe\". The relative change in total tolerance score will be compared between R-LA and racemic LA."},{"outcome_type":"primary","measure":"Comparison of serum bioavailability as measured by Area Under the Curve (0-infinity) between R-LA and racemic LA","time_frame":"Obtained at first (Visits 1 and 3) and last doses (visits 2 and 4) of each form of LA. Each visit is approximately a week apart.","description":"Serum bioavailability, as measured by Area Under the Curve (0-infinity) will be compared between R-LA and racemic LA by obtaining concentration values at times 0, 60, 90, 120, 180, and 240 minutes after ingestion of LA dose on the first (visits 1 and 3) and last doses (visits 2 and 4) of each LA form."}]}
{"nct_id":"NCT03857009","start_date":"2018-06-05","enrollment":260,"brief_title":"Why Does my Shoulder Hurt? Understanding the Presence of Pain in Individuals With Full-thickness Rotator Cuff Tears","official_title":"Why Does my Shoulder Hurt? Identifying Factors Associated With the Presence of Pain in Individuals With Full-thickness Rotator Cuff Tears","primary_completion_date":"2021-12-30","study_type":"Observational","rec_status":"Recruiting","completion_date":"2021-12-30","last_update":"2020-02-20","description":"Full-thickness rotator cuff tears (FTRCT), defined as \"through-and-through\" tears of one of the shoulder tendons, affect up to 32% of the population (mostly individuals older than 50 years) and are one of the most painful and debilitating shoulder diagnoses. One of the primary challenges for clinical decision-making is the poor association between the presence of FTRCT (detected by medical imaging) and pain, as studies have shown that 2/3 of people with FTRCT are asymptomatic. This challenges the notion that FTRCT causes pain, and highlights the fact that symptoms may be explained by other variables. A better understanding of the factors leading to the development of pain in people with FTRCT would optimize clinical care (including prevention). The objective of this study is to identify variables associated with pain in people with FTRCT by 1) comparing people with FTRCT with (Symptomatic Group; n=40) and without pain (Asymptomatic Group; n=40); 2) comparing people who initially have pain-free FTRCT (Asymptomatic Group) who develop pain over a 2-year period to those who do not develop pain; and 3) comparing people who initially have painful FTRCT (Symptomatic Group) who become pain-free over a 2-year period to those who remain symptomatic. All participants will undergo an ultrasound examination to confirm the presence of FTRCT, and information on a number of variables (sociodemographic, anatomical, genetic, psychosocial, pain sensitivity, neuromuscular, biomechanical) will be collected. All participants will then be followed for 2 years before being revaluated for pain. Variables will be analysed to determine those associated with pain. As it is crucial to improve our understanding of the mechanisms leading to pain, this project has the potential to impact the musculoskeletal health of Canadians. By considering multiple variables associated with FTRCT, its results could lead to the development of tangible solutions to optimize prevention and recovery.","other_id":"ShoulderPain2018","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":50,"maximum_age":80,"population":"Adults aged 50 to 80 years presenting with symptomatic or asymptomatic full-thickness\r\n        rotator cuff tears.","criteria":"\n        Inclusion Criteria (all participants):\r\n\r\n          -  Presence of a full-thickness rotator cuff tear (on ultrasound examination performed by\r\n             a radiologist)\r\n\r\n          -  50 to 80 years of age\r\n\r\n          -  Degenerative tear (no significant trauma)\r\n\r\n        Inclusion Criteria for the Symptomatic group:\r\n\r\n          -  unilateral or bilateral shoulder pain (at least 2/10 on a visual analog scale [VAS]\r\n             evaluating usual shoulder pain)\r\n\r\n          -  positive response to: 'In the past 4 weeks, have you had pain in your shoulder' and\r\n             'If yes, was this pain bad enough to limit your usual activities or change your daily\r\n             routine for more than 1 day?'\r\n\r\n        Inclusion Criteria for the Asymptomatic group:\r\n\r\n          -  report no current shoulder pain (0/10 on a VAS evaluating usual shoulder pain)\r\n\r\n          -  negative response to: 'In the past 4 weeks, have you had pain in your shoulder'\r\n\r\n          -  do not report any past significant shoulder pain (any pain greater than or equal to\r\n             2/10 that lasted longer than 4 weeks, required the use of medications or prompted a\r\n             physician visit)\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. unable to understand French or English;\r\n\r\n          2. history of upper limb fracture;\r\n\r\n          3. previous shoulder surgery;\r\n\r\n          4. cervicobrachialgia or shoulder pain reproduced by neck movement;\r\n\r\n          5. shoulder capsulitis (restriction of at least 30% in 2 or more directions);\r\n\r\n          6. rheumatoid, inflammatory or neurological diseases;\r\n\r\n          7. corticosteroid injection in the previous 6 weeks;\r\n\r\n          8. cognitive problems interfering with evaluations (Mini-Mental State Examination  24)\r\n      ","sponsor":"Laval University","sponsor_type":"Other","conditions":"Full-thickness Rotator Cuff Tear","interventions":{},"outcomes":[{"outcome_type":"secondary","measure":"Upper extremity work demands from baseline: Revised Upper Extremity Work Demands Scale (currently and previously)","time_frame":"Baseline score (Objective 1)","description":"6-item scale scored from 1 (\"rarely / never\") to 4 (\"almost always\"), higher scores indicate greater physical work demands on the upper extremity."},{"outcome_type":"primary","measure":"Change in usual shoulder pain from baseline: Visual analog scale (VAS)","time_frame":"From baseline to the follow-up evaluation (end of the 2-year period) (Objective 2 and 3)","description":"Participants will be asked to rate the intensity of their pain on a VAS from 0 to 10, where \"0\" represents no pain and \"10\" represents \"worst pain imaginable\", in the last week, month and 3 months. Highest possible score (worst outcome): 30. Lowest possible score (best outcome): 0. Method to compute total score: sum of each score."},{"outcome_type":"primary","measure":"usual shoulder pain from baseline: Visual analog scale (VAS)","time_frame":"Baseline score (Objective 1)","description":"Participants will be asked to rate the intensity of their pain on a VAS from 0 to 10,"},{"outcome_type":"secondary","measure":"Change from baseline with regard to: Sociodemographic and occupational factors","time_frame":"From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)","description":"General sociodemographic questionnaire including sex; gender; date of birth; age; height; weight; hand dominance; racial, ethnic or cultural origin; civil status; education level; occupation; employment status; overhead sports activities (currently or previously); household income; smoking habits"},{"outcome_type":"secondary","measure":"Sociodemographic and occupational factors","time_frame":"Baseline characteristics (Objective 1)","description":"General sociodemographic questionnaire including sex; gender; date of birth; age; height; weight; hand dominance; racial, ethnic or cultural origin; civil status; education level; occupation; employment status; overhead sports activities (currently or previously); household income; smoking habits"},{"outcome_type":"secondary","measure":"Change in disability and functional limitations of the upper extremity from baseline: QuickDASH","time_frame":"From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)","description":"Questionnaire comprising 11 questions evaluating disability and functional limitations of the upper extremity on a scale from 1 to 5, where 1 denotes full capacity and 5 denotes incapacity"},{"outcome_type":"secondary","measure":"Disability and functional limitations of the upper extremity QuickDASH","time_frame":"Baseline score (Objective 1)","description":"Questionnaire comprising 11 questions evaluating disability and functional limitations of the upper extremity on a scale from 1 to 5, where 1 denotes full capacity and 5 denotes incapacity"},{"outcome_type":"secondary","measure":"Change in comorbidities from baseline: Self-Administered Comorbidity Questionnaire","time_frame":"From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)","description":"Questionnaire determining the presence or absence of 13 health problems, whether or not the person is treated for each problem, and whether or not the problem interferes with / limits their activities"},{"outcome_type":"secondary","measure":"Comorbidities: Self-Administered Comorbidity Questionnaire","time_frame":"Baseline score (Objective 1)","description":"Questionnaire determining the presence or absence of 13 health problems, whether or not the person is treated for each problem, and whether or not the problem interferes with / limits their activities"},{"outcome_type":"secondary","measure":"Change in sleep disturbance from baseline: PROMIS Sleep Disturbance Questionnaire","time_frame":"From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)","description":"Qualitative questionnaire on a 5-point Likert scale, where higher scores indicate greater sleep quality"},{"outcome_type":"secondary","measure":"Sleep disturbance: PROMIS Sleep Disturbance Questionnaire","time_frame":"Baseline score (Objective 1)","description":"Qualitative questionnaire on a 5-point Likert scale, where higher scores indicate greater sleep quality"},{"outcome_type":"secondary","measure":"Change in prevalence and frequency of symptoms from baseline: Nordic Musculoskeletal Questionnaire","time_frame":"From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)","description":"Questionnaire evaluating the prevalence of pain (dichotomous scale, \"yes\" or \"no\") in all regions of the body (in the last week, last 3 months and last 12 months), and the frequency of pain/symptoms in each region of the body (scale from 0 to 3, where higher scores indicate higher frequency of symptoms)"},{"outcome_type":"secondary","measure":"Prevalence and frequency of symptoms from baseline: Nordic Musculoskeletal Questionnaire","time_frame":"Baseline score (Objective 1)","description":"Questionnaire evaluating the prevalence of pain (dichotomous scale, \"yes\" or \"no\") in all regions of the body (in the last week, last 3 months and last 12 months), and the frequency of pain/symptoms in each region of the body (scale from 0 to 3, where higher scores indicate higher frequency of symptoms)"},{"outcome_type":"secondary","measure":"Change in anxiety from baseline: State-Trait Anxiety Inventory","time_frame":"From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)","description":"6 items each scored on a 4-point scale, higher scores denote greater anxiety"},{"outcome_type":"secondary","measure":"Anxiety from baseline: State-Trait Anxiety Inventory","time_frame":"Baseline score (Objective 1)","description":"6 items each scored on a 4-point scale, higher scores denote greater anxiety"},{"outcome_type":"secondary","measure":"Change in depressive symptoms from baseline: Patient Health Questionnaire","time_frame":"From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)","description":"9-item questionnaire evaluating depressive symptoms, on a 4-point scale where higher scores denote higher frequency of depressive symptoms"},{"outcome_type":"secondary","measure":"Depressive symptoms from baseline: Patient Health Questionnaire","time_frame":"Baseline score (Objective 1)","description":"9-item questionnaire evaluating depressive symptoms, on a 4-point scale where higher scores denote higher frequency of depressive symptoms"},{"outcome_type":"secondary","measure":"Change in perceived stress from baseline: Perceived Stress Scale 4","time_frame":"From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)","description":"4-item questionnaire, scored on a 5-point scale from 0 (\"never\") to 4 (\"very often\"). Higher scores are correlated to more stress."},{"outcome_type":"secondary","measure":"Perceived stress from baseline: Perceived Stress Scale 4","time_frame":"Baseline score (Objective 1)","description":"4-item questionnaire, scored on a 5-point scale from 0 (\"never\") to 4 (\"very often\"). Higher scores are correlated to more stress."},{"outcome_type":"secondary","measure":"Change in upper extremity work demands from baseline: Revised Upper Extremity Work Demands Scale (currently and previously)","time_frame":"From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)","description":"6-item scale scored from 1 (\"rarely / never\") to 4 (\"almost always\"), higher scores indicate greater physical work demands on the upper extremity."},{"outcome_type":"secondary","measure":"Change in pain catastrophising from baseline: Pain Catastrophising Scale","time_frame":"From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)","description":"13-item questionnaire, 5-point scale, greater scores indicate more pain catastrophizing."},{"outcome_type":"secondary","measure":"Pain catastrophising from baseline: Pain Catastrophising Scale","time_frame":"Baseline score (Objective 1)","description":"13-item questionnaire, 5-point scale, greater scores indicate more pain catastrophizing."},{"outcome_type":"secondary","measure":"Change in Structural tissue damage of the shoulder from baseline (ultrasound evaluation performed by a radiologist)","time_frame":"From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)","description":"Full thickness rotator cuff tears will be classified by size defined as small (<10 mm), medium (10 to 30 mm) or large (>30 mm)"},{"outcome_type":"secondary","measure":"Structural tissue damage of the shoulder from baseline (ultrasound evaluation performed by a radiologist)","time_frame":"Baseline observations (Objective 1)","description":"Full thickness rotator cuff tears will be classified by size defined as small (<10 mm), medium (10 to 30 mm) or large (>30 mm)"},{"outcome_type":"secondary","measure":"Change in Acromiohumeral distance from baseline","time_frame":"From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)","description":"Ultrasound (US scanner) will be used to measure the acromiohumeral distance of the affected shoulder at 0 degrees and 60 degrees of shoulder abduction"},{"outcome_type":"secondary","measure":"Acromiohumeral distance from baseline","time_frame":"Baseline distance (Objective 1)","description":"Ultrasound (US scanner) will be used to measure the acromiohumeral distance of the affected shoulder at 0 degrees and 60 degrees of shoulder abduction"},{"outcome_type":"secondary","measure":"Change in Radiographical evaluation of the shoulder from baseline","time_frame":"From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)","description":"Presence or absence of calcific tendonitis and/or osteophytes at the glenohumeral and acromioclavicular joints"},{"outcome_type":"secondary","measure":"Radiographical evaluation of the shoulder from baseline","time_frame":"Baseline observation (Objective 1)","description":"Presence or absence of calcific tendonitis and/or osteophytes at the glenohumeral and acromioclavicular joints"},{"outcome_type":"secondary","measure":"Change in pain sensitivity from baseline: Pressure Pain Threshold (PPT)","time_frame":"From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)","description":"PPT will be assessed bilaterally at the middle deltoid and tibialis anterior muscles using a mechanical pressure algometer at an applied rate of 1 kg/s. The amount of pressure at which pain is perceived (in Newtons) will be recorded (mean of 3 trials). Higher scores denote less pain sensitivity."},{"outcome_type":"secondary","measure":"Pain sensitivity from baseline: Pressure Pain Threshold (PPT)","time_frame":"Baseline score (Objective 1)","description":"PPT will be assessed bilaterally at the middle deltoid and tibialis anterior muscles using a mechanical pressure algometer at an applied rate of 1 kg/s. The amount of pressure at which pain is perceived (in Newtons) will be recorded (mean of 3 trials). Higher scores denote less pain sensitivity."},{"outcome_type":"secondary","measure":"Change in Range of Motion (ROM) of the affected shoulder from baseline","time_frame":"From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)","description":"Shoulder ROM in flexion, lateral rotation at 0° abduction, and lateral and medial rotation at 90° abduction will be measured using a goniometer (flexion) and an inclinometer (other measures). Values will be compared to normative data according to age."},{"outcome_type":"secondary","measure":"Range of Motion (ROM) of the affected shoulder from baseline","time_frame":"Baseline ROM (Objective 1)","description":"Shoulder ROM in flexion, lateral rotation at 0° abduction, and lateral and medial rotation at 90° abduction will be measured using a goniometer (flexion) and an inclinometer (other measures). Values will be compared to normative data according to age."},{"outcome_type":"secondary","measure":"Change in Bilateral grip strength with handheld dynamometer from baseline","time_frame":"From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)","description":"Measured in pounds."},{"outcome_type":"secondary","measure":"Bilateral grip strength with handheld dynamometer from baseline","time_frame":"Baseline score (Objective 1)","description":"Measured in pounds."},{"outcome_type":"secondary","measure":"Change in Isometric shoulder strength from baseline, with manual dynamometer","time_frame":"BFrom baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)","description":"Isometric shoulder strength in abduction and in lateral rotation at 0° abduction will be measured in Newtons with a manual dynamometer (MedUp), and normalized by lever arm, measured in meters using a measuring tape."},{"outcome_type":"secondary","measure":"Isometric shoulder strength from baseline, with manual dynamometer","time_frame":"Baseline score (Objective 1)","description":"Isometric shoulder strength in abduction and in lateral rotation at 0° abduction will be measured in Newtons with a manual dynamometer (MedUp), and normalized by lever arm, measured in meters using a measuring tape."},{"outcome_type":"secondary","measure":"Change in scapular dyskinesis from baseline: Scapula Dyskinesis Test","time_frame":"From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)","description":"Bilateral scapular dyskinesis measured on a 3-point scale: normal (0 points), subtle (1 point), obvious (2 points). Higher scores indicate greater dyskinesis."},{"outcome_type":"secondary","measure":"Scapular dyskinesis from baseline: Scapula Dyskinesis Test","time_frame":"Baseline score (Objective 1)","description":"Bilateral scapular dyskinesis measured on a 3-point scale: normal (0 points), subtle (1 point), obvious (2 points). Higher scores indicate greater dyskinesis."},{"outcome_type":"secondary","measure":"Change from baseline in Shoulder proprioception (arm position matching), coordination and functional dominance with the KINARM exoskeleton (BKIN Technologies)","time_frame":"From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)","description":"Three KINARM standard tasks will be used to evaluate bilateral upper extremity neuromuscular control. Units of measurement: error in cm and task score (arm position matching task), and task score for the coordination and functional dominance tasks. Task scores are calculated by KINARM software according to variables such as precision and speed."},{"outcome_type":"secondary","measure":"Shoulder proprioception (arm position matching), coordination and functional dominance with the KINARM exoskeleton (BKIN Technologies)","time_frame":"Baseline score (Objective 1)","description":"Three KINARM standard tasks will be used to evaluate bilateral upper extremity neuromuscular control. Units of measurement: error in cm and task score (arm position matching task), and task score for the coordination and functional dominance tasks. Task scores are calculated by KINARM software according to variables such as precision and speed."}]}
{"nct_id":"NCT03362970","start_date":"2018-06-05","phase":"Phase 3","enrollment":60,"brief_title":"Improvements Through the Use of a Rapid Multiplex PCR Enteric Pathogen Detection Kit in Children With Hematochezia","official_title":"Improvements Through the Use of a Rapid Multiplex PCR Enteric Pathogen Detection Kit in Children With Hematochezia","primary_completion_date":"2021-04-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-12-31","last_update":"2020-11-06","description":"Children presenting for emergency department (ED) care with bloody diarrhea (i.e. hematochezia) represent a diagnostic challenge. Infectious enteric pathogens - Salmonella, Shigella and Shiga toxin-producing Escherichia coli (STEC) - are at the top of the differential diagnosis list. STEC is of greatest concern because ~15% of infected children develop the Hemolytic Uremic Syndrome (HUS). Our team has demonstrated that antibiotic administration to STEC-infected children increases the risk of developing HUS while dehydration is associated with mortality. Rapidly identifying children with STEC infection can reduce unnecessary resource use in uninfected children while providing them to those with confirmed STEC infection. The study team will conduct a prospective ED-based study that will randomly allocate 60 children to either standard care as dictated by the treating physician or to the use of a 22-pathogen, nucleic acid based, 1-hour run time diagnostic test. The study team will evaluate the impact of testing on clinical resource use, clinical outcomes, costs and patient satisfaction.","other_id":"REB17-1916","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":0.5,"maximum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Be aged 6 months - 17.99 years of age\r\n\r\n          2. Have 3 episodes of diarrhea within the preceding 24 hours and have blood identified\r\n             in the stool (by physician, nurse or parent)\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Previously enrolled in the study\r\n\r\n          2. Unavailable for Day 14 follow-up\r\n\r\n          3. Currently (most recent complete blood count) known to be neutropenic (Neutrophils\r\n             <1000), or at high-risk of being neutropenic (receiving chemotherapy) at present\r\n\r\n          4. Blood work performed prior to enrollment\r\n\r\n          5. Known to be STEC positive (stool culture, PCT, or toxin)\r\n\r\n          6. Pre-existing diagnosis of IBD (Crohn's disease, Ulcerative Colitis)\r\n\r\n          7. Language barrier that prevents the ability to obtain informed consent and assent (when\r\n             appropriate)\r\n      ","sponsor":"University of Calgary","sponsor_type":"Other","conditions":"Diarrhea Bloody","interventions":[{"intervention_type":"Device","name":"Device: BioFire Gastrointestinal Panel FilmArray","description":"The BioFire Gastrointestinal Panel FilmArray is a multiplexed nucleic acid (NA) based device that simultaneously identifies 22 enteric pathogens. It specifically tests for the presence of Shiga toxin and for O157. It requires 2 minutes of hands-on-time, returns results in ~2-3 hour, and is Health Canada and Food and Drug Administration approved. The device, which has been validated, hopefully will enable the early identification of infected children and initiation (or withholding) of interventions directed by previously unavailable clinical data. It will enable us to bring a precision medicine approach into ED care."},{"intervention_type":"Other","name":"Other: Standard of Care","description":"Standard practices for children with hematochezia upon the discretion of the treating physician. If investigations are ordered, results have a turn-around time up to 72 hours."}],"outcomes":[{"outcome_type":"primary","measure":"Blood test performance","time_frame":"Day 28 of the study after baseline","description":"Any blood testing performed within 72 hours of randomization."},{"outcome_type":"secondary","measure":"Intravenous fluid administration","time_frame":"Day 28 of the study after baseline","description":"Children administered IV fluids identified by chart review."},{"outcome_type":"secondary","measure":"Total physician visits (ED and non-ED)","time_frame":"Day 28 of the study after baseline","description":"Children visiting additional health-care practitioners identified by chart review."},{"outcome_type":"secondary","measure":"ED length of stay","time_frame":"Day 28 of the study after baseline","description":"ED length of stay during enrollment visit determined by chart review."},{"outcome_type":"secondary","measure":"Antibiotic use","time_frame":"Day 28 of the study after baseline","description":"Antibiotic use identified by chart review."},{"outcome_type":"secondary","measure":"Hospital and intensive care unit admission","time_frame":"Day 28 of the study after baseline","description":"Hospitalization identified by chart review."},{"outcome_type":"secondary","measure":"Diagnostic imaging performed","time_frame":"Day 28 of the study after baseline","description":"Diagnostic imaging performed identified by chart review."},{"outcome_type":"secondary","measure":"Hemolytic-Uremic Syndrome (HUS)","time_frame":"Day 28 of the study after baseline","description":"Children with HUS identified by chart review."},{"outcome_type":"secondary","measure":"Acute kidney injury","time_frame":"Day 28 of the study after baseline","description":"Based on chart review in accordance with KDIGO guidelines."},{"outcome_type":"secondary","measure":"Need for renal replacement therapy","time_frame":"Day 28 of the study after baseline","description":"Renal replacement therapy identified by chart review."},{"outcome_type":"secondary","measure":"Caregiver and Patient Satisfaction","time_frame":"Day 14 of the study after baseline","description":"Satisfaction of care received during ED visit answered in Day 14 follow-up form on a Likert scale."}]}
{"nct_id":"NCT03479788","start_date":"2018-06-04","enrollment":204,"brief_title":"Rapid Eye Movement Related OSA in Diabetic Versus Non-Diabetic Patients Treated With PCI","official_title":"Sleep and Stent Study II - Rapid Eye Movement Related Obstructive Sleep Apnea in Diabetic Versus Non-Diabetic Patients Treated With Percutaneous Coronary Intervention","primary_completion_date":"2019-09-30","study_type":"Observational","rec_status":"Completed","completion_date":"2019-09-30","last_update":"2020-03-26","description":"The primary objective of the Sleep and Stent II is to determine the prevalence of REM-OSA in DM versus non-DM patients undergoing clinically indicated PCI. The secondary objectives are to investigate the association between REM-AHI and (1) cardiac arrhythmia based on ambulatory ECG monitoring, (2) excessive daytime sleepiness, and (3) glycemic control in patients with DM. In addition, we will determine the prevalence of REM-OSA based on alternative definitions, including (a) overall AHI at least 5 with AHI REM/AHI NREM ratio at least 2; (b) overall AHI at least 5 with AHI REM/AHI NREM ratio at least 2 and with AHI NREM < 15; (c) overall AHI at least 5, AHI REM/AHI NREM ratio at least 2 and with AHI NREM < 8.","other_id":"Sleep and Stent Study II","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":22,"maximum_age":99,"population":"Patients who have undergone clinically indicated PCI between 6 and 36 months ago","criteria":"\n        Inclusion Criteria:\r\n\r\n        Age >21 years old Have undergone clinically indicated PCI between 6 and 36 months ago\r\n\r\n        Exclusion Criteria:\r\n\r\n        Known OSA on treatment Clinical instability with admission for acute coronary syndrome,\r\n        heart failure or stroke in the past 30 days Inability to give informed consent\r\n      ","sponsor":"National University, Singapore","sponsor_type":"Other","conditions":"Obstructive Sleep Apnea|Diabetes Mellitus|Coronary Artery Disease","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"REM OSA","time_frame":"1 day","description":"The primary measure of the polysomnography will be the AHI, quantified as the total number of apneas and hypopneas per hour of sleep. An apnea is defined as a 90% or greater decrease in airflow from the baseline value for at least 10 seconds. Apneas are further classified as obstructive or central based on the presence or absence, respectively, of respiratory-related chest wall movement. Hypopnea is defined as a 30-90% reduction in airflow from the baseline value lasting 10 seconds or more, in conjunction with =3% oxygen desaturation. The respiratory event scoring will be performed according to the American Academy of Sleep Medicine guidelines. For all patients the AHI during total sleep time, the AHI during REM (AHI-REM), and the AHI during non-REM sleep (AHI-NREM) will be calculated."}]}
{"nct_id":"NCT03584503","start_date":"2018-06-01","phase":"N/A","enrollment":132,"brief_title":"Effect of Use of Endotracheal Tube With Subglottic Suction in Rhinoplasty","official_title":"Effect of the Use of Endotracheal Tube With Subglottic Suction on Laryngospasm and Postoperative Complications in Rhinoplasty Operations","primary_completion_date":"2018-10-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-10-30","last_update":"2018-12-04","description":"Suction Above Cuff Endotracheal Tube (SACETT) has a dorsal port above the cuff designed to allow continuous or intermittent suctioning of secretions from the subglottic space. Thus, it facilitates suctioning of excessive secretions around the mouth and the cuff. In this study, we aimed to investigate the effect of the use of SACETT on laryngospasm and postoperative complications in rhinoplasty operations. This randomized controlled clinical trial was conducted in 132 patients undergoing rhinoplasty. The investigators believe that the use of SACETT in rhinoplasty operations reduces the incidences of laryngospasm, emergence agitation, sore throat, swallowing difficulty, and PONV when compared with classic endotracheal tube.","other_id":"SACETT","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"Single","intervention_model_description":"A randomized prospective controlled study","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients who will undergo rhinoplasty surgery,\r\n\r\n          -  American Society of Anesthesiologists (ASA) I-II patients,\r\n\r\n          -  Aged 18-65 years\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who had upper or lower respiratory tract infections,\r\n\r\n          -  asthma,\r\n\r\n          -  a history of allergy,\r\n\r\n          -  who received isoflurane and desflurane for maintenance of anesthesia,\r\n\r\n          -  who were the ASA class III-IV,\r\n\r\n          -  and who had a long uvula,\r\n\r\n          -  gastroesophageal reflux or sleep apnea,\r\n\r\n          -  electrolyte disturbances such as hypomagnesemia and hypocalcemia,\r\n\r\n          -  a BMI (body mass index) over 30 were excluded from the study.\r\n      ","sponsor":"Yuzuncu Yl University","sponsor_type":"Other","conditions":"Rhinoplasty","interventions":[{"intervention_type":"Other","name":"Other: Suction Above Cuff Endotracheal Tube","description":"Suction Above Cuff Endotracheal Tube (SACETT) has a dorsal port above the cuff designed to allow continuous or intermittent suctioning of secretions from the subglottic space"}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of laryngospasm","time_frame":"1 mounth","description":"While the presence of findings such as apnea (an apneic event was counted by either documentation of apnea by nursing notes through visual observation or documented pauses ≥15 s), desaturation (peripheral oxygen saturation <85%) and inspiratory stridor (Stridor is a harsh, vibratory sound of variable pitch caused by partial obstruction of the respiratory passages that results in turbulent airflow through the airway) after extubation was considered as laryngospasm."},{"outcome_type":"secondary","measure":"emergence agitation","time_frame":"1 mounth","description":"Riker Sedation-Agitation Scale Score ≥5 (7-Dangerous agitation: Pulling at endotracheal tube, trying to remove catheters, climbing over bedrail, striking at staff, thrashing side-to-side 6- Very agitated: Does not calm despite frequent verbal reminding of limits, requires physical restraints, biting endotracheal tube 5- Agitated: Anxious or mildly agitated, attempting to sit up, calms down on verbal instructions 4- Calm cooperative: Calm, easily arousable, follows commands 3- Sedated: Difficult to arouse, awakens to verbal stimuli or gentle shaking but drifts off again, follows simple commands 2- Very sedated: Arouses to physical stimuli but does not communicate or follow commands, may move spontaneously\r\n1- Unarousable: Minimal or no response to noxious stimuli, does not communicate or follow command)"}]}
{"nct_id":"NCT04060121","start_date":"2018-06-01","enrollment":370,"brief_title":"Efficacy of Psychological Therapies in Patients With Functional Bowel Disorders","official_title":"Efficacy of Psychological Therapies in Patients With Functional Bowel Disorders With History of Early Adverse Life Events or Post-traumatic Stress Disorder","primary_completion_date":"2021-12-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2022-12-31","last_update":"2020-12-09","description":"The purpose of this study is study bowel symptoms, quality of life, and personal factors that may affect your health. In Aim 1 of this study participants will be invited to complete 6 survey-based questionnaires online. In Aim 2 of this study will monitor the effectiveness of a 12 week therapy program on bowel symptoms and overall quality of life.","other_id":"1802270023","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"All adults' ages 18 years or older will be eligible for participation. We will solicit\r\n        participation and extend survey invitations to participants who have undergone clinical\r\n        evaluation for constipation with anorectal manometry and balloon expulsion testing at the\r\n        IU GI Motility Laboratory.","criteria":"\n        Inclusion Criteria:\r\n\r\n        Aim 1:\r\n\r\n        -Patients with a history of constipation based on clinical evaluation undergoing diagnostic\r\n        testing for dyssynergic defecation with anorectal manometry with balloon expulsion test,\r\n        ages 18 years or older.\r\n\r\n        Aim 2:\r\n\r\n          -  Patients with a history of constipation with or without dyssernergic defecation and a\r\n             positive history of EALs or PTSD, as identified in Aim 1 based on survey responses.\r\n\r\n          -  Any positive history regardless of symptom severity will be considered. Positive\r\n             history will be defined by an ACE score of 1 or higher OR a provisional diagnosis of\r\n             PTSD. A provisional PTSD diagnosis can be made by treating each PCL-5 item rated as 2\r\n             = \"Moderately\" or higher as a symptom endorsed. The diagnostic rule will require a\r\n             rating of \"moderate\" for the following: 1 B item (questions 1-5), 1 C item (questions\r\n             6-7), 2 D items (questions 8-14), and 2 E items (questions 15-20).\r\n\r\n        Exclusion Criteria:\r\n\r\n        For Aim 1, key exclusion criteria are:\r\n\r\n          -  Patients who are currently hospitalized\r\n\r\n          -  Patients who are unable to consent\r\n\r\n          -  Patients with microscopic colitis, inflammatory bowel disease, or celiac disease,\r\n             visceral cancer, or uncontrolled thyroid disease.\r\n\r\n        In Aim 2, key exclusion criteria will include the aforementioned criteria listed in Aim 1\r\n        as well as the following:\r\n\r\n          -  Patients who have bipolar disorder including active or recent hypomanic/manic episode\r\n\r\n          -  Patients at imminent risk for harm to self or others\r\n\r\n          -  Patients unable to follow orders\r\n\r\n          -  Patients who have a history of organic brain disease\r\n\r\n          -  Patient using illicit substances\r\n\r\n          -  Pregnant or post-partum patients\r\n\r\n          -  Patients who are homeless or lacking sufficient social support for follow-up care\r\n\r\n          -  Patients with acute stress disorder as determined by the GI psychologist\r\n\r\n          -  Patients with or severe PTSD as determined by the GI psychologist\r\n      ","sponsor":"Indiana University","sponsor_type":"Other","conditions":"IBS - Irritable Bowel Syndrome|Constipation","interventions":{},"outcomes":[{"outcome_type":"secondary","measure":"Constipation-related quality of life","time_frame":"12 weeks","description":"Change in constipation-related quality of life will be measured using the validated patient assessement of constipation quality of life questionnaire (higher score is worse, score range 0-4)"},{"outcome_type":"primary","measure":"Early adverse life events (EALS)","time_frame":"10-15 minutes","description":"Presence of early adverse life events will be determine by self-reported questionnaire responses to the adverse childhood experiences (ACE) questionnaire (ACE score of one or higher, range 0-8)"},{"outcome_type":"primary","measure":"Post-traumatic Stress Disorder (PTSD)","time_frame":"10-15 minutes","description":"Prevalence of PTSD will be determined by self-reported questionnaire responses to PTSD Checklist (PCL-5) questionnaire (range 0-80). A provisional PTSD diagnosis can be made by treating each item rated as 2 = \"Moderately\" or higher as a symptom endorsed, then following the DSM-5 diagnostic rule which requires at least: 1 B item (questions 1-5), 1 C item (questions 6-7), 2 D items (questions 8-14), 2 E items (questions 15-20)."},{"outcome_type":"primary","measure":"Change in weekly number of complete spontaneous bowel movements","time_frame":"12 weeks","description":"The weekly number of complete spontaneous bowel movements will be measured using a validated daily bowel diary"},{"outcome_type":"primary","measure":"Change in abdominal pain","time_frame":"12 weeks","description":"Abdominal pain will be measured using a validated daily bowel diary"},{"outcome_type":"secondary","measure":"IBS or functional constipation (FC)","time_frame":"20-30 minutes","description":"Presence of IBS or FC will be determined based on responses to the validated IBS Rome IV Questionnaire"},{"outcome_type":"secondary","measure":"Psychological comorbidities","time_frame":"20-30 minutes","description":"Existence and severity of psychological comorbidities will be measured by the validated hospital anxiety and depression scale (HADS) questionnaire (range 0-14)"},{"outcome_type":"secondary","measure":"Health-related quality of life: Short Form-12 (SF-12)","time_frame":"20-30 minutes","description":"Health-related quality of life will be measured by responses to SF-12 (higher score is better, range 0-100)"},{"outcome_type":"secondary","measure":"Constipation-related symptoms","time_frame":"12 weeks","description":"Change in constipation-related symptoms will be measured using the validated in Patient Assessment of Constipation Symptoms questionnaire (higher score is worse, score range 0-4)"}]}
{"nct_id":"NCT03510130","start_date":"2018-05-31","phase":"N/A","enrollment":300,"brief_title":"Routine Maternal Leg Movements During the Second Stage and the Rate of Operative Deliveries","official_title":"Routine Maternal Leg Movements During the Second Stage and the Rate of Operative Deliveries","primary_completion_date":"2019-01-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-03-31","last_update":"2018-05-04","description":"Cesarean delivery rates have risen in the US in a dramatic fashion from less than 5% in the 1960 to 32.7% by 2013 with stable rate around 32-33% in the last five years , cesarean delivery is associated with increased maternal morbidity and mortality, Labor arrest is the most common indication for cesarean delivery, Maternal position during the second stage of labor has been suggested to affect the risk of instrumental vaginal delivery. A Cochrane review of position in the second stage of labor in women without epidural showed a reduction in instrumental vaginal delivery in the upright group, although the quality of the included trials was reported to be generally poor, A Cochrane review of position in the second stage of labour for women with epidural analgesia was published in 2017, This review included trials that compared upright with recumbent positions and suggested no effect. No prior studies examined whether maternal legs movement during the second stage of labor has any effect on the rate of operative deliveries.","other_id":"0553-17-RMB","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":15,"maximum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Women who had a low risk pregnancy followed by an uncomplicated vaginal delivery,\r\n        instrumental delivery or cesarean section.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Women who had a high risk pregnancy ((IUGR, hypertension disorders of pregnancy, maternal\r\n        cardiovascular or respiratory illness).\r\n      ","sponsor":"Rambam Health Care Campus","sponsor_type":"Other","conditions":"Cesarean Delivery Affecting Fetus or Newborn","interventions":[{"intervention_type":"Other","name":"Other: Routine leg movement","description":"Routine leg movement to the right and left in the supine position during the second stage of labor, for 3 minutes every 20-30 minutes by the attending physician or nurse."}],"outcomes":[{"outcome_type":"primary","measure":"Routine legs movement during the second stage of labor and the rates of cesarean deliveries (In percentage of the total deliveries) and instrumental deliveries (In percentage of total deliveries)","time_frame":"up to 12 months","description":"The study objective is to determine whether routine maternal leg movement during the second stage of labor decreases the rate of operative deliveries (instrumental and cesarean deliveries)"}]}
{"nct_id":"NCT03547908","start_date":"2018-05-30","phase":"Phase 3","enrollment":244,"brief_title":"Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected Adults","official_title":"A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Nave, HIV-1 and Hepatitis B Co-Infected Adults","primary_completion_date":"2022-03-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2024-02-29","last_update":"2021-06-01","description":"The primary objective of this study is to evaluate the efficacy of fixed-dose combination (FDC) of bictegravir/emtricitabine/ tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG) + emtricitabine/tenofovir disoproxil fumarate (F/TDF) in HIV and hepatitis B virus (HBV) treatment naive, HIV-1 and HBV co-infected adults.","other_id":"GS-US-380-4458","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Key Inclusion Criteria:\r\n\r\n          -  HIV-1 co-infection:\r\n\r\n               -  Must be HIV antiretroviral treatment naive with plasma HIV-1 RNA  500 copies/mL\r\n                  at screening\r\n\r\n               -   10 days of prior therapy with any antiretroviral agent, including lamivudine\r\n                  and entecavir, following a diagnosis of HIV-1 infection (except the use for\r\n                  pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), up to one\r\n                  month prior to screening)\r\n\r\n               -  Screening genotype report must show sensitivity to emtricitabine (FTC) and\r\n                  tenofovir (TFV). This report will be provided by Gilead Sciences. Alternatively,\r\n                  if genotype results from a local laboratory obtained  90 days prior to screening\r\n                  visit date show sensitivity to these drugs, this genotype will be acceptable to\r\n                  fulfill this inclusion criterion in the event that the genotype obtained at\r\n                  screening is not yet available and all other inclusion/exclusion criteria have\r\n                  been confirmed\r\n\r\n          -  HBV co-infection:\r\n\r\n               -  Must be HBV treatment naive (defined as < 12 weeks of oral antiviral treatment)\r\n\r\n               -  Screening HBV DNA  2000 IU/mL\r\n\r\n          -  Hepatic transaminases (aspartate aminotransferase (AST) and ALT)  10 x upper limit of\r\n             normal (ULN)\r\n\r\n          -  Total bilirubin  2.5 x ULN\r\n\r\n        Key Exclusion Criteria:\r\n\r\n          -  Hepatitis C virus (HCV) antibody positive and HCV RNA detectable\r\n\r\n          -  Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or\r\n             variceal bleeding) or with Child-Pugh-Turcotte (CPT) C impairment\r\n\r\n          -  Current alcohol or substance use judged by the Investigator to potentially interfere\r\n             with study compliance\r\n\r\n          -  Active, serious infections (other than HIV-1 and HBV infection) requiring parenteral\r\n             antibiotic or antifungal therapy within 30 days prior to Day 1\r\n\r\n          -  Participation in any other clinical trial, including observational studies, without\r\n             prior approval from the sponsor is prohibited while participating in this trial\r\n\r\n        Note: Other protocol defined Inclusion/Exclusion criteria may apply.\r\n      ","sponsor":"Gilead Sciences","sponsor_type":"Industry","conditions":"HIV-1/HBV Co-Infection","interventions":[{"intervention_type":"Drug","name":"Drug: Placebo to match DTG","description":"Tablet administered orally once daily, without regard to food"},{"intervention_type":"Drug","name":"Drug: Placebo to match F/TDF","description":"Tablet administered orally once daily, without regard to food"},{"intervention_type":"Drug","name":"Drug: B/F/TAF","description":"50/200/25 mg B/F/TAF FDC tablet administered orally once daily, without regard to food"},{"intervention_type":"Drug","name":"Drug: DTG","description":"50 mg tablet administered orally once daily, without regard to food"},{"intervention_type":"Drug","name":"Drug: F/TDF","description":"200/300 mg tablet administered orally once daily, without regard to food"},{"intervention_type":"Drug","name":"Drug: Placebo to match B/F/TAF","description":"Tablet administered orally once daily, without regard to food"}],"outcomes":[{"outcome_type":"secondary","measure":"Change from Baseline in CD4 Percentage at Week 96","time_frame":"Baseline; Week 96"},{"outcome_type":"secondary","measure":"Proportion of Participants With Plasma HBV DNA < 29 IU/mL at Week 96","time_frame":"Week 96"},{"outcome_type":"secondary","measure":"Proportion of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48","time_frame":"Week 48"},{"outcome_type":"secondary","measure":"Proportion of Participants With ALT Normalization at Week 96","time_frame":"Week 96"},{"outcome_type":"secondary","measure":"Change from Baseline in CD4 Cell Count at Week 96","time_frame":"Baseline; Week 96"},{"outcome_type":"secondary","measure":"Change from Baseline in CD4 Percentage at Week 48","time_frame":"Baseline; Week 48"},{"outcome_type":"primary","measure":"Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm","time_frame":"Week 48"},{"outcome_type":"primary","measure":"Proportion of Participants With Plasma HBV DNA < 29 IU/mL at Week 48 as Defined by Missing = Failure Approach","time_frame":"Week 48"},{"outcome_type":"secondary","measure":"Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm","time_frame":"Week 96"},{"outcome_type":"secondary","measure":"Change from Baseline in CD4 Cell Count at Week 48","time_frame":"Baseline; Week 48"},{"outcome_type":"secondary","measure":"Proportion of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48","time_frame":"Week 48"},{"outcome_type":"secondary","measure":"Proportion of Participants With HBsAg Loss at Week 96","time_frame":"Week 96"}]}
{"nct_id":"NCT03445533","start_date":"2018-05-30","phase":"Phase 3","enrollment":454,"brief_title":"A Study of IMO-2125 in Combination With Ipilimumab Versus Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma (ILLUMINATE-301)","official_title":"A Randomized Phase 3 Comparison of IMO-2125 With Ipilimumab Versus Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma (ILLUMINATE-301)","primary_completion_date":"2021-06-01","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2021-09-03","last_update":"2021-07-21","description":"A Phase 3 comparison of ipilimumab with and without IMO-2125 in advanced melanoma","other_id":"2125-MEL-301","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Subjects must be willing and able to sign the informed consent and comply with the\r\n             study protocol.\r\n\r\n          2. Subjects must be 18 years of age.\r\n\r\n          3. Subjects must have histologically confirmed metastatic melanoma with measurable (by\r\n             RECIST v1.1), stage III (lymph node or in transit lesions) or stage IVA, IVB, or IVC\r\n             disease that is accessible for injection.\r\n\r\n          4. Patients must have confirmed progression during or after treatment with a PD-1\r\n             inhibitor (cannot be part of a bi-specific antibody) e.g. nivolumab or pembrolizumab.\r\n             Confirmed progression is defined as:\r\n\r\n               -  Radiological progression (confirmed at least 4 weeks after the initial scan\r\n                  showing PD); or\r\n\r\n               -  (For progression based solely on worsening of non-target or new, non-measurable\r\n                  disease) confirmation by an additional scan at least 4 weeks after the initial\r\n                  scan unless it is accompanied by correlative symptoms.\r\n\r\n             In addition, all the following must hold:\r\n\r\n               1. No intervening anti-cancer therapy between the last course of PD-1 inhibitor\r\n                  treatment and the first dose of study treatment is allowed except for local\r\n                  measures (e.g., surgical excision or biopsy, focal radiation therapy).\r\n\r\n               2. The interval between last PD-1 inhibitor and start of study treatment should be\r\n                  at least 21 days with no residual anti-PD-1-related immune toxicities in excess\r\n                  of Grade 1 severity.\r\n\r\n               3. If BRAF mutation status is unknown, before randomization the subject must have\r\n                  BRAF testing performed using an approved assay method.\r\n\r\n               4. Patients with BRAF-positive tumor(s) are eligible for the study if they received\r\n                  prior treatment with a BRAF inhibitor (alone of in combination with a MEK\r\n                  inhibitor) or declined targeted therapy.\r\n\r\n          5. Patients must have Eastern Cooperative Oncology Group (ECOG) Performance Status  1.\r\n\r\n          6. Patients must meet the following laboratory criteria:\r\n\r\n               1. Absolute neutrophil count (ANC)  1.5 x 10^9/L (1500/mm3)\r\n\r\n               2. Platelet count  75 x 10^9/L (75,000/mm3)\r\n\r\n               3. Hemoglobin  8.0 g/dL (4.96 mmol/L)\r\n\r\n               4. Serum creatinine  1.5 x upper limit of normal (ULN) or calculated creatinine\r\n                  clearance  60 mL/minute\r\n\r\n               5. Aspartate aminotransferase (AST)  2.5 x ULN; alanine aminotransferase (ALT) \r\n                  2.5 x ULN; AST/ALT < 5 x ULN if liver involvement\r\n\r\n               6. Serum bilirubin  1.5 x ULN, except in subjects with Gilbert's Syndrome who must\r\n                  have a total bilirubin < 3 mg/dL\r\n\r\n          7. Women of childbearing potential (WOCBP) and men must agree to use effective\r\n             contraceptive methods from Screening throughout the study treatment period and until\r\n             at least 90 days after the last dose of either ipilimumab or IMO-2125, whichever is\r\n             later.\r\n\r\n          8. WOCBP must have a negative pregnancy test (serum or urine).\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Ocular melanoma.\r\n\r\n          2. Prior therapy with a toll-like receptor (TLR) agonist, excluding topical agents.\r\n\r\n          3. Prior ipilimumab treatment with the exception of adjuvant treatment completed 6\r\n             months prior to enrollment\r\n\r\n          4. Systemic treatment with interferon (IFN)- within the previous 6 months.\r\n\r\n          5. Known hypersensitivity to any oligodeoxynucleotide.\r\n\r\n          6. Active autoimmune disease requiring disease-modifying therapy at the time of\r\n             Screening.\r\n\r\n          7. Subjects requiring systemic steroid therapy receiving >10 mg/day of prednisone (or\r\n             equivalent) for the 2 weeks preceding start of study.\r\n\r\n          8. Subjects with another primary malignancy that has not been in remission for at least 3\r\n             years, with the exception of non-melanoma skin cancer, curatively treated localized\r\n             prostate cancer with non-detectable prostate-specific antigen, cervical carcinoma in\r\n             situ on biopsy or a squamous intraepithelial lesion on Papanicolaou (Pap) smear, and\r\n             thyroid cancer (except anaplastic).\r\n\r\n          9. Active systemic infections requiring antibiotics\r\n\r\n         10. Active hepatitis A, B, or C infection.\r\n\r\n         11. Known diagnosis of human immunodeficiency virus (HIV) infection.\r\n\r\n         12. Women who are pregnant or breastfeeding.\r\n\r\n         13. Prior severe reaction to treatment with a human antibody that cannot be managed with\r\n             standard supportive measures.\r\n\r\n         14. Presence of known central nervous system, meningeal, or epidural metastatic disease.\r\n             However, subjects with known brain metastases are allowed if the brain metastases are\r\n             stable for 4 weeks before the first dose of study treatment. Stable is defined as\r\n             neurological symptoms not present or resolved to baseline, no radiologic evidence of\r\n             progression, and steroid requirement of prednisone 10 mg/day or equivalent\r\n\r\n         15. Impaired cardiac function or clinically significant cardiac disease.\r\n      ","sponsor":"Idera Pharmaceuticals, Inc.","sponsor_type":"Industry","conditions":"Metastatic Melanoma","interventions":[{"intervention_type":"Drug","name":"Drug: Ipilimumab","description":"4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 1, 4, 7, and 10."},{"intervention_type":"Drug","name":"Drug: IMO-2125","description":"IMO-2125 intratumoral injection administered as 9 doses on Weeks 1, 2, 3, 5, 8, 11, 16, 20, and 24."},{"intervention_type":"Drug","name":"Drug: Ipilimumab","description":"Ipilimumab administered as 4 doses on Weeks 2, 5, 8, and 11."}],"outcomes":[{"outcome_type":"primary","measure":"Compare the efficacy of IMO-2125 in combination with ipilimumab versus ipilimumab alone","time_frame":"OS is measured from the date of randomization to the date of death from any cause (up to 56 months).","description":"Efficacy measured by overall survival (OS)"},{"outcome_type":"primary","measure":"Compare the efficacy of IMO-2125 in combination with ipilimumab versus ipilimumab alone","time_frame":"Response is measured from the date of randomization, until disease progression, death, or start of new anti-cancer therapy (up to 36 months).","description":"Efficacy measure by overall response rate (ORR)"}]}
{"nct_id":"NCT03394950","start_date":"2018-05-25","phase":"Phase 4","enrollment":120,"brief_title":"Butyphthalide in Combination With Recombinant Tissue Plasminogen Activator for Acute Ischemic Stroke","official_title":"Butyphthalide in Combination With Recombinant Tissue Plasminogen Activator for Acute Ischemic Stroke (BRAIS)a Pilot, Prospective, Random, and Double Blinded Multi-center Study","primary_completion_date":"2021-05-29","study_type":"Interventional","rec_status":"Completed","completion_date":"2021-05-29","last_update":"2021-06-02","description":"Acute ischemic stroke (AIS) is the most common type of stroke, which has high rate of morbidity, mortality and disability. A large number of studies have confirmed that the thrombolytic therapy can effectively open blood vessels and improve the functional prognosis of acute ischemic stroke. Therefore, all guidelines recommend giving thrombolysis treatment to acute ischemic stroke patients within 4.5 hours of onset. However, about 1/3 patients receiving thrombolysis will have good prognosis, while a large number of patients will still be disabled and even dead. How to improve the neurofunctional prognosis of thrombolytic patients has been a hot topic in the world. Butyl phthalide is type I chemical drugs. Some multicenter randomized, double-blind, placebo-controlled clinical trials have showed that acute ischemic stroke patients taking butyl phthalide has better lateral branch circulation and living ability score than patients taking placebo. Besides, butyl phthalide treatment is safe. The animal experiment indicated that buphthalein could significantly improve secondary side branch circulation, recover the microarterial diameter of the soft meninges in the ischemic region and increase the blood flow rate. Based on the discussion, we assume that: giving butyl phthalide to patients with acute ischemic stroke in advance, might promote and improve the formation of collateral circulation to freeze ischemia penumbra. Based on this hypothesis, we would like to explore the efficacy and safety of butyl phthalide combined with rtPA thrombolysis in the treatment of acute ischemic stroke.","other_id":"k201731","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age >18 years;\r\n\r\n          2. Diagnosis of anterior circulation infarct;\r\n\r\n          3. First stroke onset or past stroke without obvious neurological deficit (mRS1);\r\n\r\n          4. Time from onset to treatment 4.5 hours;\r\n\r\n          5. SBP/DBP  180/110mmHg;\r\n\r\n          6. No hemorrhagic imaging changes showed in CT;\r\n\r\n          7. Signed informed consent by patient self or legally authorized representatives.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. History of stroke within 3 months;\r\n\r\n          2. History of intracranial hemorrhage;\r\n\r\n          3. Suspected subarachnoid hemorrhage;\r\n\r\n          4. Intracranial tumour, vascular malformation or arterial aneurysm;\r\n\r\n          5. Major surgery within 1 month;\r\n\r\n          6. Systolic pressure 180 mmHg or diastolic pressure 110 mmHg;\r\n\r\n          7. Platelet count < 100109L;\r\n\r\n          8. Heparin therapy or oral anticoagulation therapy within 48 hours;\r\n\r\n          9. Severe disease with a life expectancy of less than 3 months;\r\n\r\n         10. Blood glucose < 50 mg/dL (2.7mmol/L);\r\n\r\n         11. Patients who have received any other investigational drug or device within 3 months;\r\n\r\n         12. Researchers consider patients inappropriate to participate in the registry. -\r\n      ","sponsor":"Hui-Sheng Chen","sponsor_type":"Other","conditions":"Stroke, Ischemic","interventions":[{"intervention_type":"Drug","name":"Drug: Butyphthalide combined with rtPA","description":"Intravenous treatment with 25mg butyphthalide, followed by intravenous throbolysis with 0.9mg/kg rtPA. Next day, intravenous treatment with 25mg butyphthalide 2 times/day for 14 days, followed by oral butyphthalide capsule (0.2g 3 times/day) to 90 days after thrombolysis. Other treatments were done according to guidelines."},{"intervention_type":"Drug","name":"Drug: rtPA","description":"Intravenous thrombolysi with 0.9mg/kg rtPA, followed by other treatments according to guidelines"}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of mRS score (0-2) (90 days)","time_frame":"90 days","description":"Percentage of mRS score (0-2) at 90 days"}]}
{"nct_id":"NCT03567577","start_date":"2018-05-23","phase":"Phase 2","enrollment":80,"brief_title":"Safety and Preliminary Efficacy of Sequential Multiple Ascending Doses of Solnatide to Treat Pulmonary Permeability Oedema in Patients With Moderate-to-severe ARDS","official_title":"Safety and Preliminary Efficacy of Sequential Multiple Ascending Doses of Solnatide to Treat Pulmonary Permeability Oedema in Patients With Moderate-to-severe ARDS - a Randomised, Placebo-controlled, Double-blind Trial","primary_completion_date":"2022-05-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-05-31","last_update":"2021-07-21","description":"This phase IIb, randomized, placebo-controlled, double-blind, dose escalation study will assess the local and systemic safety of 7 days orally inhaled sequential multiple ascending doses of solnatide in patients with pulmonary permeability oedema and moderate-to-severe ARDS and review potential efficacy endpoints for a future phase III pivotal trial.","other_id":"AP301-II-002","allocation":"Randomized","intervention_model":"Sequential Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Informed consent\r\n\r\n          2. Male or female 18 years of age.\r\n\r\n          3. Patient has been admitted to an ICU, is mechanically ventilated (according to the\r\n             ventilation and weaning protocol in Appendix I) and stable in this condition for at\r\n             least 8 hours.\r\n\r\n          4. Moderate-to-severe ARDS diagnosis as defined by the Berlin Definition:\r\n\r\n               -  Onset of ARDS within 1 week of a known clinical insult or new or worsening\r\n                  respiratory symptoms.\r\n\r\n               -  Bilateral opacities not fully explained by effusions, lobar/lung collapse, or\r\n                  nodules.\r\n\r\n               -  Respiratory failure not fully explained by cardiac failure or fluid overload\r\n                  (origin of oedema).\r\n\r\n               -  PaO2/FiO2  200 mm Hg with Positive End-Expiratory Pressure (PEEP) 5 cm H2O.\r\n\r\n          5. ARDS diagnosis not older than 48 hours.\r\n\r\n          6. Extravascular lung water index (EVLWI)  10 ml/PBW as assessed with a validated\r\n             bedside measurement (single indicator transpulmonary thermodilution measurement with\r\n             the PiCCO system).\r\n\r\n          7. Patient who meets criteria for extensive hemodynamic monitoring as per international\r\n             intensive care medicine standards.\r\n\r\n          8. For patients that are temporarily unable to consent (e.g. comatose patients) a\r\n             subsequent informed consent has to be provided.\r\n\r\n          9. Male and Female (WOCBP) patients using adequate contraception.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. History of clinically relevant allergies or idiosyncrasies to solnatide.\r\n\r\n          2. Known use of any other investigational or non-registered drug within 30 days prior to\r\n             study enrolment.\r\n\r\n          3. Severe state of septic shock with a Mean Arterial Pressure (MAP)  65 mm Hg and a\r\n             serum lactate level > 4 mmol/L (36 mg/dL) despite adequate volume resuscitation.\r\n\r\n          4. An underlying clinical condition that, in the opinion of the Investigator, would make\r\n             it very unlikely for the patient to be successfully weaned from ventilation due to\r\n             severe underlying diseases (e.g. severe malnutrition, severe neurological diseases,\r\n             pulmonary fibrosis or COPD).\r\n\r\n          5. Extra-corporeal membrane oxygenation, high-frequency oscillatory ventilation or any\r\n             form of extra-corporeal lung support. In no way are patients to be denied or delayed\r\n             these procedures to avoid exclusion from the study.\r\n\r\n          6. Neutrophil count < 0.3 x 109/L.\r\n\r\n          7. Cancer treatment (chemotherapy or biological) or therapy with other immunosuppressive\r\n             agents for organ transplantation within 2 weeks.\r\n\r\n          8. Cachexia (BMI < 18.5 kg/m2).\r\n\r\n          9. Cardiogenic pulmonary oedema diagnosed by echocardiography or pulmonary artery\r\n             catheter.\r\n\r\n         10. Severe skin burns involving more than 15% of body surface.\r\n\r\n         11. Subjects who are extremely unlikely to survive more than 48 hours due to the acute\r\n             conditions of the patient in the opinion of the Investigator.\r\n\r\n         12. Subjects transferred from a hospital not participating in this study who are already\r\n             planned to be re-transferred during the observation period.\r\n\r\n         13. Subjects who are not expected to survive the next month because of an underlying\r\n             uncorrectable medical condition or a do not resuscitate order.\r\n\r\n         14. Women known to be pregnant, lactating or having a positive or indeterminate pregnancy\r\n             test.\r\n      ","sponsor":"Apeptico Forschung und Entwicklung GmbH","sponsor_type":"Industry","conditions":"ARDS","interventions":[{"intervention_type":"Drug","name":"Drug: Solnatide 25 mg powder for reconstitution for solution for inhalation","description":"Inhalation of an aerosol every 12 hours ( 30 min), for a total of 7 days."},{"intervention_type":"Drug","name":"Drug: 0.9% Saline Solution","description":"Inhalation of an aerosol every 12 hours ( 30 min), for a total of 7 days."}],"outcomes":[{"outcome_type":"primary","measure":"Safety endpoint: Any cause death","time_frame":"Randomisation - day 28","description":"Primary Safety Endpoint: Composite endpoint including any cause death at day 28"},{"outcome_type":"primary","measure":"Safety endpoint: Drug-related adverse events","time_frame":"Randomisation - day 14","description":"Primary Safety Endpoint: Composite endpoint including drug-related adverse events through day 14"},{"outcome_type":"primary","measure":"Safety endpoint: All adverse events","time_frame":"Randomisation - day 28","description":"Primary Safety Endpoint: Composite endpoint including all adverse events through day 28"},{"outcome_type":"secondary","measure":"EVLWI","time_frame":"baseline - day 7","description":"Change in extravascular lung water index (EVLWI) as assessed with a validated bedside measurement (measurement with the PiCCO® system)"},{"outcome_type":"secondary","measure":"PVPI","time_frame":"baseline - day 7","description":"Change in pulmonary vascular permeability index (PVPI) as assessed with a validated bedside measurement (measurement with the PiCCO® system)"},{"outcome_type":"secondary","measure":"Change of ventilatory settings","time_frame":"baseline - day 14","description":"Composite endpoint including ventilation mode, ventilation pressures (ventilatory plateau pressure, positive end expiratory pressure, peak inspiratory pressure, mean airway pressure, peak airway pressure, driving pressure), tidal volume"},{"outcome_type":"secondary","measure":"Murray lung injury score","time_frame":"baseline - day 7","description":"Murray lung injury score is composed of four components: 1) chest radiograph; 2) hypoxaemia score; 3) PEEP and 4) static compliance of respiratory system. The values of the total score may range from 0 to 4. Lower values indicate a better outcome."},{"outcome_type":"secondary","measure":"Oxygenation ratio (PaO2 / FiO2 ratio)","time_frame":"baseline - day 7"},{"outcome_type":"secondary","measure":"Time to extubation","time_frame":"baseline - day 28"},{"outcome_type":"secondary","measure":"Ventilator-free days (VFD)","time_frame":"baseline - day 28"},{"outcome_type":"secondary","measure":"Days of hospitalization and in ICU","time_frame":"baseline - day 28"}]}
{"nct_id":"NCT03543982","start_date":"2018-05-23","phase":"N/A","enrollment":37,"brief_title":"Effects of Oral Probiotic Product on Vaginal Microbial Community and Parameters of Vaginal Health","official_title":"An Open-label, Pilot Study to Assess the Effects of an Oral Probiotic Product on the Vaginal Microbial Community and on Parameters of Vaginal Health","primary_completion_date":"2020-10-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2021-03-18","last_update":"2021-04-08","description":"The purpose of the study is to assess the efficacy and safety of an oral probiotic product on the vaginal microbiome and on parameters of vaginal health. Eligible subjects will utilize the investigational product as directed for a period of 28 days. The vaginal microbial community and parameters of vaginal health will be measured at baseline and after 14 and 28 days of supplementation. A follow-up post-supplementation visit will be conducted on Day 42.","other_id":"UAS1RPD-160001-PRVH","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Healthy women aged 18-50 years.\r\n\r\n          2. Body mass index 18.5 - 34.9 kg/m2 (inclusive).\r\n\r\n          3. Have childbearing potential [i.e. not surgically sterile or post-menopausal (greater\r\n             than one year since last menses)].\r\n\r\n          4. Non-smoker, or ex-smoker 6 months.\r\n\r\n          5. Nugent score of 4-6 or pH >4.5\r\n\r\n          6. Agrees to maintain current level of physical activity and dietary habits throughout\r\n             the trial period.\r\n\r\n          7. Agrees to discontinue use of probiotic supplements (oral or vaginal), as well as food\r\n             supplemented with probiotics or prebiotics.\r\n\r\n          8. Willing and able to provide written informed consent.\r\n\r\n          9. Agrees to provide fecal samples during the trial period.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Hypersensitivity to any ingredient in the study product.\r\n\r\n          2. Pregnancy or planning pregnancy.\r\n\r\n          3. Lactation or breast feeding.\r\n\r\n          4. Irregular menstrual cycles.\r\n\r\n          5. Use of contraceptives that contain spermicidal agents.\r\n\r\n          6. Use of an intrauterine device (IUD).\r\n\r\n          7. Use of hormonal therapy through cervical cap.\r\n\r\n          8. Use of douching devices.\r\n\r\n          9. Any major trauma or surgical event within the 3 months prior to screening.\r\n\r\n         10. Individuals undergoing therapies to prevent any recurrent infections.\r\n\r\n         11. Allergy to any antibiotic that may be prescribed as a rescue remedy during the study.\r\n\r\n         12. Use of prescription drugs (other than birth control) within 1 month prior to Visit 1.\r\n\r\n         13. Use of antibiotics within 2 months prior to Visit 1.\r\n\r\n         14. History of blood clotting disorders or use of coagulation-inhibiting drugs (e.g.\r\n             warfarin)\r\n\r\n         15. Presence of systemic diseases or immunodeficiencies\r\n\r\n         16. Abdominal or gastrointestinal surgery within the previous 12 months.\r\n\r\n         17. Recent gastrointestinal food-borne illness (within 1 month prior to Visit 1)\r\n\r\n         18. History of cancer (excluding non-melanoma skin cancer and basal cell carcinoma) in the\r\n             past 5 years\r\n\r\n         19. Abnormal laboratory test results of clinical significance\r\n\r\n         20. Presence or history (past 6 months) of alcohol or drug abuse\r\n\r\n         21. Subject is unwilling or unable to abide by the requirements of the protocol\r\n\r\n         22. Any condition that would interfere with the subject's ability to comply with study\r\n             instructions, might confound the interpretation of the study, or put the subject at\r\n             risk\r\n\r\n         23. Subject has taken an investigational health product or has participated in a research\r\n             study within 30 days prior to first study visit\r\n      ","sponsor":"UAS Labs LLC","sponsor_type":"Industry","conditions":"Vaginal Health","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Oral probiotic product","description":"Once per day (QD), 28 days"}],"outcomes":[{"outcome_type":"primary","measure":"Changes in vaginal microbial community, via next generation sequencing.","time_frame":"Day 28"},{"outcome_type":"secondary","measure":"Changes in vaginal microbial community, via next generation sequencing.","time_frame":"Day 14 and 42"},{"outcome_type":"secondary","measure":"Changes in vaginal pH.","time_frame":"Day 14, 28 and 42"},{"outcome_type":"secondary","measure":"Changes in Nugent Score (Scale of 0 to 10).","time_frame":"Day 14, 28 and 42"},{"outcome_type":"secondary","measure":"Parameters of well-being, via Vulvovaginal Symptom Questionnaire.","time_frame":"Day 14, 28 and 42"},{"outcome_type":"secondary","measure":"Safety as assessed by routine chemistry and hematology, and the monitoring of adverse events.","time_frame":"Day 14, 28 and 42"},{"outcome_type":"secondary","measure":"Compliance as assessed by capsule counts of the returned IP.","time_frame":"Day 14, 28 and 42"},{"outcome_type":"other","measure":"Colonization of the vaginal microbiome.","time_frame":"Day 14, 28 and 42"},{"outcome_type":"other","measure":"Colonization of the GI microbiome.","time_frame":"Day 14, 28 and 42"}]}
{"nct_id":"NCT03688594","start_date":"2018-05-22","phase":"N/A","enrollment":60,"brief_title":"Non Invasive Prenatal Test of Rare Genetic Diseases: Application to Rare Intellectual Disabilities","official_title":"Non Invasive Prenatal Test of Rare Genetic Diseases: Application to Rare Intellectual Disabilities","primary_completion_date":"2019-05-22","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-05-23","last_update":"2018-09-28","description":"The aim of this study is to evaluate performances of a NIPT test based onto the study of the maternal blood to search known genetic mutations already detected in the family and potentially inherited by the fetus. This test will avoid an invasive prenatal diagnosis in those families with a known genetic risk. The performance of this test will be evaluated in terms of sensitivity and specificity with an adapted statistic model. Secondary objectives of the protocol are - To adapt NIPT to small DNA quantity (5-50 ng) - To adapt bioinformatics pipeline to low rate of mosaicism - To develop a tool to quantify the fetal fraction - To evaluate the robustness of the method This test is based onto capture and high throw put sequencing adapted to cell free plasmatic DNA of pregnant women in order to detect point mutation present in her fetus. This approach has been previously described for others clinical applications such as liquid biopsy in cancers but not for NIPT analysis.","other_id":"6792","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Couple (father, mother) > 18 ans\r\n\r\n          -  Pregnant woman (> 12-15 weeks of gestation) with a fetal sampling needed in standard\r\n             care.\r\n\r\n          -  informed consent obtained\r\n\r\n          -  couple affiliated to the social insurance in France\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  DNA extraction failure\r\n\r\n          -  Absence of informed consent\r\n\r\n          -  Father or mother placed under judicial protection or under guardianship or tutorship\r\n      ","sponsor":"University Hospital, Strasbourg, France","sponsor_type":"Other","conditions":"Genetic Disorders in Pregnancy","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: NIPT Test","description":"This test is based onto capture and high throw put sequencing adapted to cell free plasmatic DNA of pregnant women in order to detect point mutation present in her fetus. This approach has been previously described for others clinical applications such as liquid biopsy in cancers but not for NIPT analysis."}],"outcomes":[{"outcome_type":"secondary","measure":"Comparison of SNV detection efficiency of several bioinformatics pipeline Robustness evaluation in function of - Fetal percent in cfDNA - Genomic region - Initial input of cfDNA","time_frame":"Measurement will be performed at the end of the protocol (12 months)"},{"outcome_type":"primary","measure":"Detection yield of fetal paternally transmitted single nucleotid variations (SNV) in free cell maternal DNA Absence of non fetal paternally transmitted single nucleotid variations (SNV) in maternal free cell DNA (cfDNA)","time_frame":"Measurement will be performed at the end of the protocol (12 months)"}]}
{"nct_id":"NCT03544827","start_date":"2018-05-21","phase":"Phase 4","enrollment":36,"brief_title":"The Effects of Low Dose Atropine on Choroidal Thickness","official_title":"The Effects of Low Dose Atropine on Choroidal Thickness","primary_completion_date":"2019-02-08","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-02-08","last_update":"2019-02-15","description":"Atropine eye drops are considered to be an effective form of myopia control in human eyes. However, the mechanism by which it exerts it effects are not fully understood. Thickening of the choroid subsequent to atropine administration may play an important role in the mechanisms by which atropine induces myopia control. Literature also notes that choroidal thickness undergoes diurnal variations, which is a variable that will be controlled in this study in order to examine atropine's effects on different baseline choroidal thicknesses. The purpose of the proposed study is to characterize better the influence of atropine on choroid thickness. The study aims are to: 1. Determine the effect of low dose concentration of topical atropine (0.1% and 0.01%) on choroid thickness 2. Determine the effect of topical atropine on choroid thickness in relationship to baseline thickness throughout the day and after one week of daily instillation Hypothesis: Atropine's effect on choroidal thickness will be dependent on the subject's baseline thickness measurements, at a designated time of the day when the choroid is at its thinnest.","other_id":"1168531-2","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":35,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Aged between 18 - 35 years\r\n\r\n          -  Good general and ocular health\r\n\r\n          -  Soft contact lens wearers to cease lens wear for at least 24 hours\r\n\r\n          -  No previous rigid gas permeable lens wear\r\n\r\n          -  Not taking monoamine oxidase inhibitors (MAOIs) and are not pregnant\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of ocular surgery, including refractive surgery\r\n\r\n          -  Use of ocular medications\r\n\r\n          -  Amblyopia\r\n\r\n          -  Conditions where topical atropine is contraindicated\r\n\r\n          -  Any eye or systemic disease that affect vision or refractive error\r\n      ","sponsor":"State University of New York College of Optometry","sponsor_type":"Other","conditions":"Myopia","interventions":[{"intervention_type":"Drug","name":"Drug: Atropine","description":"Atropine 0.01% then atropine 0.1%"},{"intervention_type":"Drug","name":"Drug: Atropine","description":"Atropine 0.1% then atropine 0.01%"}],"outcomes":[{"outcome_type":"primary","measure":"Choroidal thickness","time_frame":"1 hour, 4 hours, 8 hours, and 1 week from baseline measurement","description":"Measure choroidal thickness changes at baseline and compare to choroidal thickness after intervention of atropine 0.01% and atropine 0.1%"},{"outcome_type":"secondary","measure":"Visual acuity","time_frame":"1 hour, 4 hours, 8 hours, and 1 week from baseline measurement","description":"Measure distance and near visual acuity at baseline and re-measure after intervention of atropine 0.01% and atropine 0.1% for any changes"},{"outcome_type":"secondary","measure":"Axial length","time_frame":"1 hour, 4 hours, 8 hours, and 1 week from baseline measurement","description":"Measure axial length at baseline and compare to changes after intervention of atropine 0.01% and atropine 0.1%"},{"outcome_type":"secondary","measure":"Lens thickness","time_frame":"1 hour, 4 hours, 8 hours, and 1 week from baseline measurement","description":"Measure lens thickness at baseline and compare to changes after intervention of atropine 0.01% and atropine 0.1%"},{"outcome_type":"secondary","measure":"Anterior chamber depth","time_frame":"1 hour, 4 hours, 8 hours, and 1 week from baseline measurement","description":"Measure anterior chamber depth at baseline and compare to changes after intervention of atropine 0.01% and atropine 0.1%"},{"outcome_type":"secondary","measure":"Quality of Vision (QoV) Questionnaire","time_frame":"1 hour, 4 hours, 8 hours, and 1 week from baseline measurement","description":"The questionnaire is a Rasch-tested, linear-scaled, 30-item instrument on three scales providing a QoV score in terms of symptom frequency, severity, and bothersome. There are four options of increasing severity of symptoms from none, mild, moderate, and to severe for each item. The use of Rasch analysis turns the original questionnaire responses (raw ordinal data) into continuous interval data, providing a linear measurement; it is on a linear interval scale."},{"outcome_type":"secondary","measure":"Tear break up time (TBUT)","time_frame":"Baseline and 1 week from baseline measurement","description":"Sodium fluorescein dye is added to the eye and the tear film is observed under the slit lamp while the patient avoids blinking until tiny dry spots develop; compare any differences between baseline and after one week of atropine use"},{"outcome_type":"secondary","measure":"Schirmer strip test","time_frame":"Baseline and 1 week from baseline measurement","description":"Measure amount of tear production; compare value at baseline to values after 1 week of atropine use to determine if tear production is affected with atropine use"},{"outcome_type":"secondary","measure":"Ocular Surface Disease Index (OSDI)","time_frame":"Baseline and 1 week from baseline measurement","description":"This is a 12-item questionnaire with 5 options from 0 to 5 (with 0 indicating none of the time, and increases to 5 indicating all of the time). The sum of the scores across the 12 items are totaled, and inputted into a formula to generate a sliding scale of the disease condition. The scale ranges from 0 to 100, with higher scores representing greater disability of the disease condition. This questionnaire will be completed at baseline and after 1 week of atropine use to compare for any differences."}]}
{"nct_id":"NCT03648320","start_date":"2018-05-18","phase":"N/A","enrollment":40,"brief_title":"The Grown Up Peanut Immunotherapy Study","official_title":"A Single Arm Phase II Efficacy Study of Peanut Oral Immunotherapy in Adults","primary_completion_date":"2020-09-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-09-30","last_update":"2018-08-27","description":"To determine efficacy and safety of peanut oral immunotherapy in adults with peanut allergy.","other_id":"225583","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        For peanut OIT patients:\r\n\r\n        Adults aged 18-40 years with:\r\n\r\n          1. A positive skin prick test to peanut extract.\r\n\r\n          2. Elevated (>0.35) serum specific Immunoglobulin E (IgE) to Ara h 2 major peanut\r\n             allergen within 2 years of date of initial screening visit.\r\n\r\n          3. Positive DBPCFC to 300mg or less of peanut protein.\r\n\r\n          4. Where appropriate, use of effective form of birth control by females for the duration\r\n             of participation in the study (i.e. up to exit DBPCFC).\r\n\r\n          5. Participants with asthma may be included if well controlled:\r\n\r\n               -  Asthma control questionnaire (ACQ) score <1\r\n\r\n               -  Maximum permitted asthma treatment: moderate dose of inhaled corticosteroid (ICS)\r\n                  and long-acting beta agonists (LABA) as treatment\r\n\r\n               -  Pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1) >80% of predicted\r\n                  value at screening visit\r\n\r\n               -  For asthmatic participants with intermittent mild symptoms (induced by exercise,\r\n                  animals or pollens) using as required salbutamol only, treatment will be given\r\n                  with regular low dose inhaled corticosteroids (ICS) prior to challenges and for\r\n                  the duration of updosing as an additional measure.\r\n\r\n        For mechanistic sub-study subjects:\r\n\r\n        Adults aged 18-40 years with:\r\n\r\n          1. A positive skin prick test to peanut extract within previous 12 months\r\n\r\n          2. Elevated serum specific IgE (>0.35) to Ara h 2 major peanut allergen within 2 years of\r\n             date of initial screening visit.\r\n\r\n          3. Clinical diagnosis of peanut allergy made by an experienced allergy specialist.\r\n\r\n        Exclusion Criteria:\r\n\r\n        For peanut OIT patients:\r\n\r\n          1. Anaphylaxis to a food other than peanut - despite attempted avoidance - within the\r\n             last 2 years.\r\n\r\n          2. History of life-threatening anaphylaxis or angioedema, including previous intensive\r\n             care unit (ITU) admission attributable peanut allergy.\r\n\r\n          3. Asthmatic treated with higher than moderate dose of ICS (>800 mcg equivalent of\r\n             beclomethasone dipropionate (BDP) per day).\r\n\r\n          4. Any asthmatic if uncontrolled or difficult to control as evidenced by any following:\r\n             ACQ>1; FEV1 <80% predicted; FEV1/ forced vital capacity (FVC) <0.7 irrespective of\r\n             treatment; hospital attendance (A&E or admission) for asthma in the past 2 years;\r\n             treatment of asthma with oral steroids within last 2 years.\r\n\r\n          5. Evidence of non-adherence with asthma treatment from General PRactitioner (GP) repeat\r\n             prescription records.\r\n\r\n          6. Participants who react to less than 1 mg of peanut protein on DBPCFC, or who cannot\r\n             tolerate at least an initial dose of 1.5 mg peanut protein on OIT initiation day.\r\n\r\n          7. Participants who react to placebo during DBPCFC.\r\n\r\n          8. Ongoing treatment with beta-blockers, biologics (such as omalizumab or mepolizumab) or\r\n             systemic immunosuppressive treatment.\r\n\r\n          9. Regular ongoing use of NSAIDs for a chronic condition (NSAIDs may act as a co-factor\r\n             for allergic reactions)\r\n\r\n         10. For females a positive serum or urine pregnancy test with sensitivity of less than 50\r\n             mIU/mL within 72 hours of first administration of study therapy.\r\n\r\n         11. Lactating females.\r\n\r\n         12. The use of any investigational drug within 30 days of the screening visit.\r\n\r\n         13. Past history of eosinophilic oesophagitis or chronic gastro-oesophageal reflux\r\n             symptoms requiring regular treatment with anti-acids.\r\n\r\n         14. Inability to discontinue antihistamines for a minimum of 4 days prior to DBPCFC visits\r\n\r\n         15. The presence of any medical condition that the investigator deems incompatible with\r\n             participation in the trial.\r\n\r\n         16. Individuals with insufficient understanding of the trial.\r\n\r\n        For mechanistic sub-study subjects:\r\n\r\n          1. Ongoing treatment with biologic or systemic immunosuppressive treatment.\r\n\r\n          2. Known current pregnancy\r\n\r\n          3. Lactating females.\r\n\r\n          4. The use of any investigational drug within 30 days of the screening visit.\r\n\r\n          5. Inability to discontinue antihistamines for a minimum of 4 days prior to venesection.\r\n\r\n          6. The presence of any medical condition that the investigator deems incompatible with\r\n             participation in the study.\r\n\r\n          7. Individuals with insufficient understanding of the study.\r\n      ","sponsor":"Guy's and St Thomas' NHS Foundation Trust","sponsor_type":"Other","conditions":"Peanut Allergy","interventions":[{"intervention_type":"Other","name":"Other: Peanut oral immunotherapy","description":"Daily doses of peanut flour (with 2-weekly incremental interval)"}],"outcomes":[{"outcome_type":"primary","measure":"Desensitisation to 1.4g peanut","time_frame":"7-8 months","description":"Tolerance of cumulative dose of 1.4g peanut protein without reaction on DBPCFC post OIT after minimum of 1 month maintenance dosing on peanut OIT"},{"outcome_type":"secondary","measure":"Desensitisation to 4.4g peanut","time_frame":"7-8 months","description":"Tolerance of cumulative dose of 4.4 g peanut protein without reaction on DBPCFC post OIT"},{"outcome_type":"secondary","measure":"Incidence of adverse events related to treatment (safety)","time_frame":"7-8 months","description":"Incidence of local and systemic reactions during peanut OIT updosing and maintenance"},{"outcome_type":"secondary","measure":"Reactions with ara h 8 sensitisation","time_frame":"7-8 months","description":"Comparison of local and systemic reactions in Ara h 8 sensitised vs. non-sensitised subjects."},{"outcome_type":"secondary","measure":"Skin prick test reactivity","time_frame":"9 months","description":"Change in size of wheal diameter to peanut extract following OIT"},{"outcome_type":"secondary","measure":"Immunoglobulin G (IgG) levels","time_frame":"9 months","description":"Change in peanut-specific IgG following OIT"},{"outcome_type":"secondary","measure":"Quality of life measure","time_frame":"7-8 months","description":"Change measured using Food Allergy Quality of Life Questionnaire- Adult Form (FAQLQ-AF) and the Food Allergy Independent Measure Adult Form (FAIM-AF). These are validated questionnaires consisting of 29 (FAQLQ-AF) and 6 (FAIM-AF) questions each scored on a 7 point likert scale. The total scores are the mean score of all items with a range of 1 'no impairment' to 7 'maximal impairment'."},{"outcome_type":"secondary","measure":"Food Neophobia score","time_frame":"7-8 months","description":"Change measured using validated Food Neophobia Scale (FNS) questionnaire. This consists of 8 questions with answers on a 7 point likert scale ranging from 1 (\"disagree strongly\") to 7 (\"agree strongly\"). The total score is the mean score of all questions with lower score signifying increased food neophobia."},{"outcome_type":"secondary","measure":"Food Situations score","time_frame":"7-8 months","description":"Change using Food Situations Questionnaire, validated in children and amended to be appropriate for adults. 10 different scenarios related to food are rated from 1 (very unhappy) to 5 (very happy), giving a total possible score of 50. Higher scores are indicative of lower food neophobia."},{"outcome_type":"secondary","measure":"Study compliance","time_frame":"7-8 months","description":"Compliance with OIT measured using monthly diaries."}]}
{"nct_id":"NCT03514381","start_date":"2018-05-18","phase":"Phase 4","enrollment":59,"brief_title":"Pharmacologic Interaction Between Ifosfamide and Aprepitant in Treated Patients With Soft Tissue Sarcoma","official_title":"Pharmacologic Interaction Between Ifosfamide and Aprepitant in Treated Patients With Soft Tissue Sarcoma","primary_completion_date":"2020-11-23","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-11-23","last_update":"2021-01-12","description":"This trial is a multicentric study aiming to assess the evolution of the serum ifosfamide concentrations and its serum metabolites in patients treated for an Soft Tissue Sarcoma and co-exposed to Aprepitant. The study will be conducted on a population of patients treated with Doxorubicin and Ifosfamide. The Aprepitant can be prescribed to patients from cycle 2, according to the current recommendations. Doxorubicin, Ifosfamide and Aprepitant will be administered in the context of routine care. The follow-up during the treatment period and the clinical, biological and radiological assessments will be performed according to the standard of each centre. Patients will be followed during the two first cycles of treatment. For the pharmacokinetic study, blood samples will be collected at different time points during the 2 treatment cycles.","other_id":"17 SARC 04","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age  18 years.\r\n\r\n          2. Anatomopathologic diagnosis of soft tissue sarcoma (localized, local recidive or\r\n             metastatic).\r\n\r\n          3. Patient receiving doxorubicin and ifosfamide chemotherapy (treatment decided during\r\n             Multidisciplinary consultation meetings) (neoadjuvant, adjuvant or palliative\r\n             treatment).\r\n\r\n          4. Screening laboratory values must meet the following criteria:\r\n\r\n               1. Hemoglobin > 9.0 g/dL, Neutrophils > 1500/mm3, Platelets > 100000/mm3\r\n\r\n               2. Creatinine clearance (MDRD formula) > 60ml/min.\r\n\r\n               3. AST/ALT < 2.5 x ULN (5 x ULN in patients with hepatic metastasis).\r\n\r\n          5. Evaluable disease (measurable per RECIST or not), if applicable.\r\n\r\n          6. Patient must provide written informed consent prior to any study specific procedures.\r\n\r\n          7. Patient affiliated to a Social Health Insurance in France.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Previous treatment with Ifosfamide.\r\n\r\n          2. Patient who has already started doxorubicin and ifosfamide treatment.\r\n\r\n          3. Any medical condition that can increase the patient's risk\r\n\r\n               1. Active infection\r\n\r\n               2. Active hepatitis or cirrhosis\r\n\r\n               3. Recipients of organ transplants or immunocompromised patients, including Human\r\n                  Immunodeficiency Virus (HIV) infection\r\n\r\n          4. Pregnant or breastfeeding women\r\n\r\n          5. Any psychological, familial, geographical or sociological condition which does not\r\n             allow to respect the medical follow-up and/or compliance to study procedure\r\n\r\n          6. Patient protected by law\r\n      ","sponsor":"Institut Claudius Regaud","sponsor_type":"Other","conditions":"Soft Tissue Sarcoma","interventions":[{"intervention_type":"Drug","name":"Drug: Patients starting a treatment with Doxorubicin and Ifosfamide","description":"9 blood samples will be collected at each Cycle:\r\nCycle 1 (Day 1-Day 2-Day 3)\r\nCycle 2 (Day 1-Day 2-Day 3)"}],"outcomes":[{"outcome_type":"primary","measure":"Evolution of 2d-Ifo plasma concentrations between the 1st cycle (without co-exposure to the Aprepitant) and the 2nd cycle (with co-exposure to the Aprepitant)","time_frame":"Cycle 2 Day 3 for each patient"},{"outcome_type":"secondary","measure":"Toxicity assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03","time_frame":"Cycle 3 Day 1 for each patient"},{"outcome_type":"secondary","measure":"Evolution of plasma concentrations of ifosfamide and its serum metabolites between the first and second cycles","time_frame":"Cycle 3 Day 1 for each patient"},{"outcome_type":"secondary","measure":"The rate of objective responses determined according to the criteria RECIST v 1.1","time_frame":"Cycle 3 Day 1 for each patient"}]}
{"nct_id":"NCT03478969","start_date":"2018-05-17","phase":"N/A","enrollment":181,"brief_title":"Participant-Reported Outcomes With the Accu-Chek Solo Micropump System","official_title":"Patient-Reported Outcomes With the Accu-Chek Solo Micropump System vs. Multiple Daily Injection Therapy vs. Mylife OmniPod in Patients With Type 1 Diabetes","primary_completion_date":"2020-05-18","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-05-18","last_update":"2021-08-20","description":"This interventional device study aims to compare mainly standard Multiple Daily Injection (MDI) therapy vs. Accu-Chek Solo Micropump System and investigates participant satisfaction. In addition, a third arm is included to compare to only similar product on the market which is OmniPod. The third arm is for data collection purpose.","other_id":"RD002718","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosed type 1 diabetes mellitus\r\n\r\n          -  At least 6 months experience with MDI therapy\r\n\r\n          -  Age 18 years and age  65\r\n\r\n          -  Able to perform carbohydrate counting\r\n\r\n          -  Clinically suitable for CSII including willingness to measure blood glucose at least 4\r\n             times per day or to use flash or real-time continuous glucose monitoring consistently\r\n\r\n          -  HbA1c between 7.5% (58 millimoles per mole (mmol/mol)) and 9.0% (75 mmol/mol)\r\n             (determined within the last 2 months)\r\n\r\n          -  Ability and willingness to read and understand study materials (participant\r\n             information, data protection and written consent form, all questionnaires etc.) and to\r\n             comply with study procedures\r\n\r\n          -  Ability and willingness to use investigational devices independently and respond to\r\n             alarms after training and run-in phase\r\n\r\n          -  Using a blood glucose (BG)-meter or real-time continuous glucose monitoring device\r\n             that can be downloaded via Accu-Chek Smart Pix or willingness to use a compatible\r\n             meter that will be provided for the duration of the study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior insulin pump use\r\n\r\n          -  Relevantly impaired hypoglycemia awareness\r\n\r\n          -  History of >1 hospitalization due to severe hypoglycemia within the previous 3 months\r\n\r\n          -  History of >1 hospitalization due diabetic ketoacidosis within the last 3 months\r\n\r\n          -  Significant manifestation of diabetes-related late complications\r\n\r\n          -  Pregnant or planning to become pregnant or breastfeeding\r\n\r\n          -  Known allergic reactions to plaster adhesive\r\n\r\n          -  Chronic use (therapy lasting for more than 3 months) of steroids in adrenal\r\n             suppressive doses, immunosuppressive medication, or chemotherapy\r\n\r\n          -  Serious or unstable chronic medical or psychological condition(s)\r\n\r\n          -  Addiction to alcohol or other substance(s) of abuse as determined by the investigator\r\n\r\n          -  Psychological condition rendering the participant unable to understand the nature and\r\n             the scope of the study\r\n\r\n          -  Plans for relocation or extensive travel\r\n\r\n          -  Participation in another clinical study within 4 weeks prior to the screening visit\r\n\r\n          -  Dependency on Sponsor or Investigator (e.g. co-worker or family member)\r\n      ","sponsor":"Hoffmann-La Roche","sponsor_type":"Industry","conditions":"Diabetes Mellitus, Type 1","interventions":[{"intervention_type":"Device","name":"Device: Accu-Chek Solo micropump system","description":"Medical device for subcutaneous delivery of insulin in a personalized way."},{"intervention_type":"Device","name":"Device: mylife OmniPod Insulin Management System","description":"A patch pump system delivering insulin."},{"intervention_type":"Other","name":"Other: Multiple Daily Injections (MDI) therapy","description":"Injecting insulin as per participant's need."}],"outcomes":[{"outcome_type":"secondary","measure":"Therapy Success Indicated by Change in Body Mass Index (BMI)","time_frame":"Baseline up to Week 39","description":"This outcome measure represents one reported value calculated by combining weight and height to report BMI in kg/m^2. Change in BMI from Baseline to Week 39."},{"outcome_type":"secondary","measure":"Therapy Success Indicated by Change in Weight","time_frame":"Baseline up to Week 39","description":"Change in Weight from Baseline to Week 39"},{"outcome_type":"secondary","measure":"Change in Glycemic Index","time_frame":"Baseline up to Week 39","description":"Change in Glycemic Index from Baseline to Week 39"},{"outcome_type":"secondary","measure":"Number of Participants With Therapy Parameters Indicated by Commencement of Continuous Subcutaneous Insulin Infusion (CSII)","time_frame":"Baseline up to Week 39","description":"Continuous Subcutaneous Insulin Infusion (CSII) therapy is also referred to as Insulin Pump Therapy. Presented below, are the Number of Participants for whom certain indications e.g. HbA1c goals not met, resulted in commencement of CSII therapy."},{"outcome_type":"secondary","measure":"Change in Therapy Parameters Based on Type of Insulin Used","time_frame":"Baseline up to Week 39"},{"outcome_type":"primary","measure":"Treatment Satisfaction: Accu-Chek® Micropump System vs. MDI, Measured by the Difference in the Diabetes Technology Questionnaire (DTQ) Total Change Score","time_frame":"26 weeks","description":"The two comparisons will be performed using a hierarchical procedure. First, the comparison between the Accu-Chek® Solo system vs. MDI will be performed and only if the corresponding Null hypothesis of no difference between both systems can be rejected, then the second comparison between Accu-Chek® Solo system and versus mylife™ OmniPod® will also be performed. The DTQ questionnaire consists of 30 questions with the individual Change Scores ranging from 1 to 5, where 1 represents 'Much worse' and 5 represents 'Much better'. The Total Change Score Range on this questionnaire is from 30 to 150 with higher scores representing lower impairment and improved outcomes."},{"outcome_type":"primary","measure":"Treatment Satisfaction: Accu-Chek® Micropump System vs. Mylife™ OmniPod®, Measured by the Difference in the Diabetes Technology Questionnaire (DTQ) Total Change Score","time_frame":"26 weeks","description":"The two comparisons will be performed using a hierarchical procedure. First, the comparison between the Accu-Chek® Solo system vs. MDI will be performed and only if the corresponding Null hypothesis of no difference between both systems can be rejected, then the second comparison between Accu-Chek® Solo system and versus mylife™ OmniPod® will also be performed. The DTQ questionnaire consists of 30 questions with the individual Change Scores ranging from 1 to 5, where 1 represents 'Much worse' and 5 represents 'Much better'. The Total Change Score Range on this questionnaire is from 30 to 150 with higher scores representing lower impairment and improved outcomes."},{"outcome_type":"secondary","measure":"Diabetes-Related Emotional Distress Assessed by Problem Areas in Diabetes Scale (PAID)-5","time_frame":"Week 26 up to Week 39","description":"The PAID-5 questionnaire consisted of 5 questions with answers ranging from 0 (not a problem) to 4 (serious problem). The total score was calculated as the sum of the individual questions, resulting in a number between 0 and 20 where lower scores represented lower distress."},{"outcome_type":"secondary","measure":"Device Satisfaction and Treatment Preference","time_frame":"Baseline up to Week 39","description":"Device Satisfaction and Treatment Preference was the main focus of part 2 questions of the DTQ. This part of the DTQ questionnaire consisted of individual sections with 9 questions each for the Blood Glucose Meter and Insulin Pump. Individual scores ranged from 1 (terrible) to 5 (excellent). Thus, the resulting sum score ranged from 9 to 45 for each type of device."},{"outcome_type":"secondary","measure":"Therapy Success Confirmed by Glycated Hemoglobin (Hb1Ac) Levels","time_frame":"Baseline up to Week 39","description":"Change in Glycated Haemoglobin (HbA1c) Levels from Baseline to Week 39"},{"outcome_type":"secondary","measure":"Change in Therapy Parameters Indicated by Total Daily Insulin Dose (TDD)","time_frame":"Baseline up to Week 39","description":"Total Daily Insulin Dose at Baseline compared to dose at Week 39"},{"outcome_type":"secondary","measure":"Change in Therapy Parameters Indicated by Total Daily Basal Insulin Dose (TBD)","time_frame":"Baseline up to Week 39","description":"Total Daily Basal Insulin Dose at Baseline compared to dose at Week 39"},{"outcome_type":"secondary","measure":"Change in Therapy Parameters Based on Average Number of Self Monitoring of Blood Glucose (SMBGs) Per Day","time_frame":"Baseline up to Week 39","description":"Average Number of Self Monitoring of Blood Glucose (SMBGs) per day from Baseline up to Week 39"},{"outcome_type":"secondary","measure":"Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges","time_frame":"Baseline up to Week 39","description":"Change in Frequency of Hypoglycaemic Events are reported below as the percentage of time spent in hypoglycaemic blood glucose (BG) ranges."},{"outcome_type":"secondary","measure":"Percentage of Time Spent in Hyperglycaemic Blood Glucose (BG) Ranges","time_frame":"Baseline up to Week 39","description":"Change in Frequency of Hyperglycaemic Events are reported below as the percentage of time spent in hyperglycaemic blood glucose (BG) ranges."},{"outcome_type":"secondary","measure":"Number of Consultations","time_frame":"Baseline up to Week 39","description":"Consultations between scheduled visits, emergency and call center calls, hospitalizations and absenteeism from work/school."},{"outcome_type":"secondary","measure":"Number of Pods/Infusion Assemblies Falling Off Prematurely","time_frame":"Baseline up to Week 39"},{"outcome_type":"secondary","measure":"Average Time Spent on Infusion Assembly","time_frame":"Baseline up to Week 39"},{"outcome_type":"secondary","measure":"Number of Participants With Skin Reactions (Including Type and Intensity)","time_frame":"Baseline up to Week 39","description":"Number of Participants who experienced Skin Reactions at the Insulin Pump Insertion Sites (along with their Type and Intensity) are presented below, from Baseline up to Week 39. Participants were asked to assess five different properties describing potential problems at the pump insertion site, namely \"itching\", \"redness\", \"swelling\", \"heat\" and \"pain\". Each of these questions could be answered with one of four alternatives, \"None\", \"Minor\", \"Moderate\" and \"Severe\"."},{"outcome_type":"secondary","measure":"Socio-economic Acceptance: Amount of Insulin Left in Device at Reservoir Change/Device Discard","time_frame":"Baseline up to Week 39"},{"outcome_type":"secondary","measure":"Amount of Waste, Inferred by Total Material Consumption","time_frame":"Baseline up to Week 39"}]}
{"nct_id":"NCT03566238","start_date":"2018-05-16","phase":"Phase 3","enrollment":62,"brief_title":"This Study Will Investigate the Efficacy and Safety of A4250 in Children With PFIC Types 1 or 2","official_title":"A Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study to Demonstrate Efficacy and Safety of A4250 in Children With Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 1)","primary_completion_date":"2020-07-27","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-07-28","last_update":"2021-09-05","description":"Double blind, randomized, placebo controlled, Phase 3 study to investigate the efficacy and safety of low doses and high doses of A4250 compared to placebo in children with progressive familial intrahepatic cholestasis (PFIC) types 1 and 2.","other_id":"A4250-005","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","intervention_model_description":"Double-Blind, Randomized, Placebo-Controlled","sampling_method":"","gender":"All","minimum_age":0.5,"maximum_age":18,"population":"","criteria":"\n        Key Inclusion Criteria:\r\n\r\n          -  A male or female participant with a clinical diagnosis of PFIC Type 1 or 2 and with a\r\n             body weight above 5 kg\r\n\r\n          -  Participant must have clinical genetic confirmation of PFIC-1 or PFIC-2\r\n\r\n          -  Participant must have elevated serum bile acid (s-BA) concentration\r\n\r\n          -  Participant must have history of significant pruritus and a caregiver reported\r\n             observed scratching in the eDiary\r\n\r\n          -  Participant and/or legal guardian must sign informed consent (and assent) as\r\n             appropriate.\r\n\r\n          -  Participants will be expected to have a consistent caregiver(s) for the duration of\r\n             the study\r\n\r\n          -  Caregivers and age-appropriate participants (8 years of age) must be willing and able\r\n             to use an eDiary device as required by the study\r\n\r\n        Key Exclusion Criteria:\r\n\r\n          -  Participant with pathologic variations of the ABCB11 gene that predict complete\r\n             absence of the bile salt export pump (BSEP) protein\r\n\r\n          -  Participant with past medical history or ongoing presence of other types of liver\r\n             disease including, but not limited to, the following:\r\n\r\n               1. Biliary atresia of any kind\r\n\r\n               2. Benign recurrent intrahepatic cholestasis, indicated by any history of normal s\r\n                  BAs\r\n\r\n               3. Suspected or proven liver cancer or metastasis to the liver on imaging studies\r\n\r\n               4. Histopathology on liver biopsy that is suggestive of alternate non-PFIC related\r\n                  etiology of cholestasis\r\n\r\n          -  Participant with past medical history or ongoing chronic diarrhea\r\n\r\n          -  Any participant with suspected or confirmed cancers except for basal cell carcinoma\r\n\r\n          -  Participant with a past medical history of chronic kidney disease with an impaired\r\n             renal function and a glomerular filtration rate <70 mL/min/1.73 m^2\r\n\r\n          -  Participant with surgical history of disruption of the enterohepatic circulation\r\n             (biliary diversion surgery) within 6 months prior to start of Screening Period\r\n\r\n          -  Participant has had a liver transplant or a liver transplant is planned within 6\r\n             months of randomization\r\n\r\n          -  Decompensated liver disease\r\n\r\n          -  Participant suffers from uncontrolled, recalcitrant pruritic condition other than PFIC\r\n\r\n          -  Participant who has been previously treated with an IBAT inhibitor whose pruritus has\r\n             not responded to treatment\r\n      ","sponsor":"Albireo","sponsor_type":"Industry","conditions":"PFIC1|PFIC2","interventions":[{"intervention_type":"Drug","name":"Drug: A4250 (odevixibat)","description":"A4250 is a small molecule and selective inhibitor of ileal bile acid transporter (IBAT)."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo identical in appearance to active drug (A4250)."}],"outcomes":[{"outcome_type":"primary","measure":"Proportion of Positive Pruritus Assessments at the Participant Level Over the 24-week Treatment Period Based on the Albireo Observer-reported Outcome (ObsRO) Instrument (United States Primary Endpoint)","time_frame":"Over 24 weeks of treatment","description":"ObsRO instrument was used to assess severity of observed scratching twice a day (AM and PM) with score from 0 to 4 where 0 is no scratching and 4 is worst possible scratching. A positive pruritus assessment was defined as a scratching score of <= 1 or at least one point drop from baseline. At each post baseline assessment over the 24-week treatment period, the AM score was compared to the baseline AM average and the PM score was compared to the baseline PM average. Both AM and PM pruritus assessments were included in the analysis. Any intermittently missing assessment or missing planned assessment after premature treatment discontinuation, death, or initiation of rescue treatment was classified as negative assessment. Proportion of positive pruritus assessments at the participant level over the 24-week was then calculated. Full analysis set was used for the analysis."},{"outcome_type":"primary","measure":"Percentage of Participants Experiencing at Least a 70% Reduction in Fasting s-BA Concentration From Baseline to the End of Treatment or Reaching a Level <= 70 μmol/L After 24 Weeks of Treatment (European Union and Rest of the World Primary Endpoint)","time_frame":"Over 24 weeks of treatment","description":"Fasting s-BA baseline was calculated as the average of the last 2 values prior to the first dose. The end value was the average of the values at Weeks 22 and 24 after the start of double-blind treatment. Participants who had at least 70% reduction in Fasting s-BA from baseline to the end of treatment or reached <=70 μmol/L after 24 weeks of treatment were considered as responder. Participants with missing average at the end of treatment were classified as non-responder. Full analysis set was used for the analysis."}]}
{"nct_id":"NCT03535948","start_date":"2018-05-15","enrollment":90,"brief_title":"Elderly Hodgkin Lymphoma Patients Treated With Chemoradiotherapy","official_title":"Outcome of Hodgkin Lymphoma Patients Over Than 60 Years Treated by Chemotherapy and/or Radiotherapy: a Retrospective Study","primary_completion_date":"2019-11-30","study_type":"Observational","rec_status":"Unknown status","completion_date":"2019-12-31","last_update":"2019-06-17","description":"Outcome of Hodgkin lymphoma patients over than 60 years treated by chemotherapy and/or radiotherapy: retrospective analysis.","other_id":"PSS2016/hodgSA-CLEMENT-F/AS","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":60,"population":"All Hodgkin lymphoma patients over 60 years treated between 2000 and 2013 by chemotherapy\r\n        and/or radiotherapy in two university hospitals in France","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients over than 60 years\r\n\r\n          -  Newly diagnosed Hodgkin lymphoma\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Data not available\r\n      ","sponsor":"Central Hospital, Nancy, France","sponsor_type":"Other","conditions":"Hodgkin Lymphoma, Adult","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Progression-free survival","time_frame":"Time between diagnosis and progression or death - up to 100 weeks","description":"From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months"}]}
{"nct_id":"NCT03555942","start_date":"2018-05-08","phase":"N/A","enrollment":44,"brief_title":"Luteal Phase-start Ovarian Stimulation With Corifollitropin Alfa","official_title":"Follicular or Luteal Start Ovarian Stimulation With Corifollitropin Alfa. A Prospective Equivalence Study With Repeated Ovarian Stimulation in Oocyte Donors","primary_completion_date":"2021-09-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-12-30","last_update":"2021-02-10","description":"To evaluate the effect of random-start of ovarian stimulation initiated in the early follicular or luteal phase on the pharmacokinetics and follicular dynamics and embryo euploidy rates in oocyte donors treated with identical ovarian stimulation protocols with corifollitropin alfa and GnRH antagonist pituitary downregulation","other_id":"FSD-COR-2017-01","allocation":"Non-Randomized","intervention_model":"Sequential Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Overall, 44 oocyte donors women will be asked to participate in a trial in which they will undergo 2 consecutive ovarian stimulation protocols within a period of 6 months with 150g corifollitropin alfa followed by 200 IU rFSH in a fixed GnRH antagonist protocol starting in the early follicular, and luteal menstrual cycle phase","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":35,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Healthy eligible oocyte donors\r\n\r\n          2. Age 18-34 years\r\n\r\n          3. AFC >12 and AMH>1.5 ng/ml\r\n\r\n          4. BMI 19-28kg/m2\r\n\r\n          5. Body weight >60kg\r\n\r\n          6. Both ovaries present\r\n\r\n          7. Willing to participate in the study\r\n\r\n          8. Willing to use non-hormonal contraception or not needing contraception Recipients will\r\n             be eligible only if their partners' sperm which will be used for ICSI will be normal.\r\n             Couples will be excluded in case of moderate to severe oligoasthenospermia.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Endometriosis\r\n\r\n          2. AFC>20\r\n\r\n          3. PCOS\r\n\r\n          4. Low ovarian reserve\r\n\r\n          5. Endocrine abnormalities\r\n\r\n          6. Hormonal contraception\r\n\r\n          7. Contraindication of hormonal treatment\r\n\r\n          8. History of Ovarian Hyperstimulation Syndrome or hyper-response (> 30 follicles .\r\n\r\n        11mm)\r\n      ","sponsor":"Institut Universitari Dexeus","sponsor_type":"Other","conditions":"Infertility","interventions":[{"intervention_type":"Drug","name":"Drug: Follicular phase corifollitropin alfa","description":"GnRH antagonist protocol with corifollitropin alfa initiated in the follicular phase (day 2 or 3 of the menstrual cycle)"},{"intervention_type":"Drug","name":"Drug: Luteal phase corifollitropin alfa","description":"GnRH antagonist protocol with corifollitropin alfa initiated in the luteal phase (5 days after an LH peak)"}],"outcomes":[{"outcome_type":"primary","measure":"Mean number of euploid embryos","time_frame":"15-45 days following oocyte retrieval procedure","description":"Number of euploid embryos between oocytes received from follicular phase or luteal phase initiation of ovarian stimulation."},{"outcome_type":"secondary","measure":"Number of oocytes","time_frame":"9 -20 days from initiation of ovarian stimulation","description":"The outcome will be evaluated on the day of oocyte retrieval"},{"outcome_type":"secondary","measure":"Number of MIIs","time_frame":"9 -20 days from initiation of ovarian stimulation","description":"The outcome will be evaluated on the day of oocyte retrieval"},{"outcome_type":"secondary","measure":"Total additional dose of rFSH (IU)","time_frame":"9 -20 days from initiation of ovarian stimulation","description":"Addition total units of FSH following corifollitropin alfa.The outcome will be evaluated on the day of final oocyte maturation"},{"outcome_type":"secondary","measure":"Duration of ovarian stimulation","time_frame":"9 -20 days from initiation of ovarian stimulation","description":"Total days of ovarian stimulation .The outcome will be evaluated on the day of final oocyte maturation"},{"outcome_type":"secondary","measure":"Endocrine profile at specific intervals","time_frame":"Stimulation day 1, day 6, day 8, and Day of final oocyte maturation (actual day may vary between 9-15)","description":"Estradiol, LH, FSH, Progesterone"},{"outcome_type":"secondary","measure":"Clinical pregnancy rates following transfer of embryos generated from oocytes from follicular phase vs. luteal phase stimulation","time_frame":"5-8 weeks after embryo transfer procedure","description":"Clinical pregnancy rates , presence of intrauterine gestational sac with an embryonic pole demonstrating cardiac activity"}]}
{"nct_id":"NCT03467152","start_date":"2018-05-04","phase":"Phase 2","enrollment":320,"brief_title":"Study To Evaluate the Efficacy, Safety and Tolerability of E2027 in Participants With Dementia With Lewy Bodies","official_title":"A Placebo-Controlled, Double-Blind, Parallel-Group, Randomized, Study To Evaluate the Efficacy, Safety and Tolerability of E2027 in Subjects With Dementia With Lewy Bodies","primary_completion_date":"2020-04-15","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-04-15","last_update":"2021-04-08","description":"This study will be conducted to compare E2027 to placebo on the cognitive endpoint of Montreal Cognitive Assessment (MoCA) and the global clinical endpoint of Clinician's Interview Based Impression of Change Plus (CIBIC-Plus) Caregiver Input in participants with dementia with Lewy bodies after 12 weeks of treatment.","other_id":"E2027-G000-201","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":50,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female, age 50 to 85 years, inclusive at time of consent.\r\n\r\n          -  Meet criteria for probable dementia with Lewy bodies (DLB) (as defined by the 4th\r\n             report of the DLB Consortium).\r\n\r\n          -  Mini-Mental State Examination greater than or equal to ()14 and less than or equal to\r\n             () 26 at Screening Visit.\r\n\r\n          -  Has experienced visual hallucinations during the past 4 weeks before Screening Visit.\r\n\r\n          -  If receiving acetylcholinesterase inhibitors (AChEI), must have been on a stable dose\r\n             for at least 12 weeks before Screening Visit, with no plans for dose adjustment during\r\n             the study. Treatment-naive participants can be entered into the study but there should\r\n             be no plans to initiate treatment with AChEIs from Screening to the end of the study.\r\n\r\n          -  If receiving memantine, must have been on a stable dose for at least 12 weeks before\r\n             Screening Visit, with no plans for dose adjustment during the study. Treatment naive\r\n             participants can be entered into the study but there should be no plans to initiate\r\n             treatment with memantine from Screening to the end of the study.\r\n\r\n          -  Must have an identified caregiver or informant who is willing and able to provide\r\n             follow-up information on the participant throughout the course of the study.\r\n\r\n          -  Provide written informed consent. If a participant lacks capacity to consent in the\r\n             investigator's opinion, the participant's assent should be obtained, as required in\r\n             accordance with local laws, regulations and customs, plus the written informed consent\r\n             of a legal representative should be obtained (capacity to consent and definition of\r\n             legal representative should be determined in accordance with applicable local laws and\r\n             regulations). In countries where local laws, regulations, and customs do not permit\r\n             participants who lack capacity to consent to participate in this study, they will not\r\n             be enrolled.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any neurological condition that may be contributing to cognitive impairment above and\r\n             beyond those caused by the participant's DLB, including any comorbidities detected by\r\n             clinical assessment or magnetic resonance imaging (MRI).\r\n\r\n          -  History of transient ischemic attacks or stroke within 12 months of Screening.\r\n\r\n          -  Modified Hachinski Ischemic Scale greater than (>) 4.\r\n\r\n          -  Parkinsonian (extrapyramidal) features with Hoehn and Yahr stage 4 intravenous or\r\n             higher.\r\n\r\n          -  Any major psychiatric diagnosis, including schizophrenia, bipolar disorder and current\r\n             major depressive disorder as per Diagnostic and Statistical Manual of Mental Disorders\r\n             Fifth Edition.\r\n\r\n          -  Geriatric Depression Scale score > 8.\r\n      ","sponsor":"Eisai Inc.","sponsor_type":"Industry","conditions":"Dementia With Lewy Bodies","interventions":[{"intervention_type":"Drug","name":"Drug: E2027","description":"Oral hypromellose capsules."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Oral hypromellose capsules."}],"outcomes":[{"outcome_type":"secondary","measure":"Mean Change from Baseline in the NPI Subscore at 12 Weeks of Treatment","time_frame":"Baseline; Week 12","description":"The NPI scale assesses the frequency and severity of 12 neuropsychiatric symptoms commonly described in dementia participants: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, nighttime behaviors, and appetite/eating changes. The NPI subscore covers the 4 domains of delusions, hallucinations, apathy, and depression."},{"outcome_type":"primary","measure":"Mean Change from Baseline in the Montreal Cognitive Assessment (MoCA) Total Score at 12 Weeks of Treatment","time_frame":"Baseline; Week 12","description":"The MoCA scale assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. It is useful to characterize global cognitive impairment in dementia with Lewy bodies. The total possible score is 30 points; a score of 26 or above is considered normal."},{"outcome_type":"primary","measure":"Mean Clinician's Interview Based Impression of Change Plus Caregiver Input (CIBIC-Plus) Scale Score at 12 Weeks of Treatment","time_frame":"Baseline; Week 12","description":"The CIBIC-Plus scale is designed to measure various domains that describe participant function: general, mental/cognitive state, behavior, and activities of daily living. It is a semi-structured global rating derived from a comprehensive interview with the participant and caregiver or informant by an independent rater who has no access to the source data or other psychometric test scores conducted post-randomization as part of the protocol. The CIBIC-Plus scores are: 1 (marked improvement), 2 (moderate improvement), 3 (minimal improvement), 4 (no change), 5 (minimal worsening), 6 (moderate worsening), and 7 (marked worsening)."},{"outcome_type":"secondary","measure":"Mean Clinician's Global Impression of Change - In Dementia With Lewy Bodies (CGIC-DLB) Scale Score at 12 Weeks of Treatment","time_frame":"Baseline; Week 12","description":"The CGIC-DLB scale provides an overall clinician-determined summary measure of change from the participant's clinical status at the Baseline Visit that takes into account all available information from the efficacy endpoints (which include cognitive function, non-cognitive symptoms, behavior, and the impact of the symptoms on the participant's ability to function) and safety data."},{"outcome_type":"secondary","measure":"Mean Change from Baseline in the Cognitive Fluctuation Inventory (CFI) Score at 12 Weeks of Treatment","time_frame":"Baseline; Week 12","description":"The CFI scale assesses cognitive fluctuation with the same format as the Neuropsychiatric Inventory (NPI). It evaluates fluctuation in various domains including attention, ability to perform daily functions, orientation, verbal communication and behavior. It is scored based on frequency and severity with a score range of 0 to 12. The scale also assesses the degree of caregiver or informant distress engendered by the symptoms."},{"outcome_type":"secondary","measure":"Mean Change from Baseline in the Mini-Mental State Examination (MMSE) Total Score at 12 Weeks of Treatment","time_frame":"Baseline; Week 12","description":"The MMSE is a 30-point scale that measures orientation to time and place, registration, immediate and delayed recall, attention, language, and drawing. Scores range from 0 (most impaired) to 30 (no impairment)."},{"outcome_type":"secondary","measure":"Mean Change from Baseline in the NPI Total Score at 12 Weeks of Treatment","time_frame":"Baseline; Week 12","description":"This NPI scale assesses the frequency and severity of 12 neuropsychiatric symptoms commonly described in dementia participants: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, nighttime behaviors, and appetite/eating changes. The scale also assesses the degree of caregiver or informant distress engendered by each of the symptoms. It is rated from 0 to 144, with higher scores indicating a greater neuropsychiatric disturbance. A subscore covering the domains of delusions, hallucinations, apathy, and depression (NPI-4) will also be derived."},{"outcome_type":"secondary","measure":"Mean Change from Baseline in the NPI Caregiver Score at 12 Weeks of Treatment","time_frame":"Baseline; Week 12","description":"The NPI scale assesses the frequency and severity of 12 neuropsychiatric symptoms commonly described in dementia participants: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, nighttime behaviors, and appetite/eating changes. The scale also assesses the degree of caregiver distress engendered by each of the symptoms. It is rated from 0 to 144, with higher scores indicating a greater neuropsychiatric disturbance."},{"outcome_type":"secondary","measure":"Percentage of Participants with Adverse Events (AEs), including Severe Adverse Events, Serious AEs, AEs Resulting in Study Discontinuation","time_frame":"Up to 22 Weeks","description":"Adverse Events (AEs) will be graded for severity on a 3-point scale of mild, moderate, and severe. Severe AEs defined as those AEs that are incapacitating, with inability to work or to perform normal daily activity. A Serious AE is any untoward medical occurrence that at any dose: results in death; is life threatening (ie, the participant was at immediate risk of death from the adverse event as it occurred; this does not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death) requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria."},{"outcome_type":"secondary","measure":"Percentage of Participants with Orthostatic Hypotension and Orthostatic Tachycardia","time_frame":"Up to 22 Weeks"},{"outcome_type":"secondary","measure":"Percentage of Participants with Markedly Abnormal Laboratory Values and Shift from Baseline in Laboratory Values","time_frame":"Up to 22 Weeks"},{"outcome_type":"secondary","measure":"Percentage of Participants with Abnormal Electrocardiogram (ECG) Parameters and ECG Findings","time_frame":"Up to 22 Weeks"},{"outcome_type":"secondary","measure":"Percentage of Participants with Suicidal Ideation or Suicidal Behavior as Measured Using Columbia Suicide Severity Rating Scale (C-SSRS)","time_frame":"Up to 22 Weeks","description":"The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories); is an interview-based instrument to systematically assess suicidal ideation and suicidal behavior. C-SSRS assess whether participant experience any of the following: completed suicide; suicide attempt (response of \"yes\" on \"actual attempt\"); preparatory acts toward imminent suicidal behavior (\"yes\" on \"preparatory acts or behavior\", \"aborted attempt\" or \"interrupted attempt\"), suicidal ideation (\"yes\" on \"wish to be dead\", \"non-specific active suicidal thoughts\", \"active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent (\"yes\" on \"has participant engaged in non-suicidal self-injurious behavior\"). Here, number of participants with positive response (\"yes\") to suicidal behavior or/and Ideation, any non-suicidal self-injurious behavior will be reported."},{"outcome_type":"secondary","measure":"Change from Baseline in Total Score of Unified Parkinson's Disease Rating Scale part III: Motor Examination (UPDRS-III)","time_frame":"Baseline, Week 12, and Week 16","description":"The UPDRS scale evaluates extrapyramidal features in motor function in Parkinson's disease. It contains 33 items in 18 categories: (1) speech, (2) facial expression, (3) rigidity, (4) finger tapping, (5) hand movements, (6) supination and pronation movements of hands, (7) toe tapping, (8) leg agility, (9) arising from chair, (10) gait, (11) freezing of gait, (12) postural stability, (13) posture, (14) body bradykinesia, (15) postural tremor of hands, (16) kinetic tremor of hands, (17) rest tremor amplitude and (18) constancy of rest tremor. Each item is scored 0 to 4, giving a total score range 0 to 132."}]}
{"nct_id":"NCT03514940","start_date":"2018-05-02","enrollment":130,"brief_title":"Perinatal Diagnosis of GIT Anomalies","official_title":"Perinatal Diagnosis of Fetal GIT Anomalies","primary_completion_date":"2020-06-03","study_type":"Observational","rec_status":"Recruiting","completion_date":"2020-07-07","last_update":"2020-01-27","description":"fetal gastro intestinal abnormalities can be accurately diagnosed in second trimester","other_id":"GIT","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"Female","minimum_age":20,"maximum_age":40,"population":"pregnant ladies either primi or multigravida","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  pregnant women either primi or multigravida\r\n\r\n          -  pregnant in 18- 24 weeks\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  first trimester pregnant ladies\r\n      ","sponsor":"Aljazeera Hospital","sponsor_type":"Other","conditions":"Fetal Anomalies","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: ultrasound","description":"second trimester us scan will be made to pregnant women"}],"outcomes":[{"outcome_type":"primary","measure":"The number of participants who will be diagnosed to have GIT anomalies","time_frame":"within 5 moths","description":"GIT anomalies that will be diagnosed by US and confirmed postnatal and managed operatively"}]}
{"nct_id":"NCT04907838","start_date":"2018-05-01","phase":"N/A","enrollment":22,"brief_title":"Insulin Stimulated Vasodilation in Patients With Type 2 Diabetes","official_title":"Insulin Stimulated Vasodilation in Patients With Type 2 Diabetes","primary_completion_date":"2021-07-30","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2021-07-30","last_update":"2021-06-01","description":"This study evaluates the role of endothelin in insulin stimulated vasodilation and glucose uptake. The subjects will complete an hyperinsulinemic euglycemic clamp with and without blockade of the endothelin receptors.","other_id":"s-20180040","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":40,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Type 2 diabetes OR healthy control (no type 2 diabetes)\r\n\r\n          -  BMI<32\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  heart disease\r\n\r\n          -  pregnancy or birth within 3 month\r\n\r\n          -  smoking\r\n\r\n          -  Kidney disease\r\n\r\n          -  beta-blockers\r\n\r\n          -  insulin treatment (for type 2 diabetics)\r\n      ","sponsor":"University of Southern Denmark","sponsor_type":"Other","conditions":"Type2 Diabetes","interventions":[{"intervention_type":"Drug","name":"Drug: Insulin clamp","description":"Continous infusion insulin + glucose"},{"intervention_type":"Drug","name":"Drug: BQ123","description":"Continuous infusion of Insulin + glucose + BQ123"},{"intervention_type":"Drug","name":"Drug: BQ123 + BQ788","description":"Continous infusion of insulin + glucose + BQ123 + BQ788"}],"outcomes":[{"outcome_type":"primary","measure":"Glucose infusion rate","time_frame":"3.5 hours","description":"Glucose infusion rate required to maintain euglycemia during insulin clamp with and without endothelin blockade"},{"outcome_type":"primary","measure":"Leg blood flow","time_frame":"3.5 hours","description":"Effect of endothelin receptor blockade on leg blood flow (ultrasound Doppler) during insulin clamp with and without endothelin blockade"}]}
{"nct_id":"NCT03448211","start_date":"2018-05-01","phase":"Phase 1","enrollment":0,"brief_title":"A Study of PTS for Patients With Solid Tumors","official_title":"A Phase I Open-Label, Dose-Escalation Study of Para-toluenesulfonamide Injection (PTS) Administered Intratumorally and Locally to Patients With Solid Tumors","primary_completion_date":"2019-05-01","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2019-08-01","last_update":"2018-04-05","description":"The primary objective of this study is to determine the MTD of PTS following local and intratumoral injections over a treatment course of two 5-day cycles to patients with palpable advanced solid malignancies who have failed standard treatment.","other_id":"US-01","intervention_model":"Sequential Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subjects are diagnosed as unsuitable for surgical operations or refuse to do so.\r\n\r\n          -  Subject's performance status is classified as Grade 0 to Grade 3. Estimated survival\r\n             time should be longer than 6 months of time.\r\n\r\n          -  Physical examinations show no serious functional disorders of the heart, liver,\r\n             kidneys, or blood.\r\n\r\n          -  Subjects were treated with radio or chemotherapy previously. A minimum of 2 to 3\r\n             months recovery time is required before treating with this investigational drug.\r\n\r\n          -  Subject is diagnosed as intratracheal lesions with metastasized pulmonary cancer not\r\n             suitable for surgery, or refuses to be operated.\r\n\r\n          -  Subject should show lobular atelectasis with either complete or incomplete obstruction\r\n             of the bronchi.\r\n\r\n          -  Physical examinations should show no functional disorders of the heart, liver,\r\n             kidneys, central nervous system, and blood.\r\n\r\n          -  Subject performance status to be classified from Grade 0 to Grade 3, who can tolerate\r\n             the fiberoptic bronchoscopy treatments.\r\n\r\n          -  In-patient is preferred. When subject is in satisfactory conditions, the out Cpatient\r\n             can also be enrolled in this trial.\r\n\r\n          -  Two to three months recovery time is required for the subject has just received radio\r\n             or chemotherapy.\r\n\r\n          -  Emergency request, subjects with serious lobular atelectasis and almost complete\r\n             obstruction of the bronchi.\r\n\r\n          -  With the aid of a tracheal intubation and the help of the respirator, PTS may be\r\n             intraumorally injected into the obstructed lesion via fiberoptic bronchoscopy outside\r\n             of the tube, alongside of the intubation.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnant women and children will not be used as test subjects.\r\n\r\n          -  Subjects with serious functional disorders of the heart, liver, kidneys, or blood will\r\n             be excluded.\r\n\r\n          -  Subjects who do not want to participate in the trial will not be used as test\r\n             subjects.\r\n\r\n          -  Subject does not agree to participate.\r\n\r\n          -  Subject performance status is Grade 4, and the one who does not want to tolerate the\r\n             discomfort of the PTS treatments via fiberoptic bronchscopy.\r\n      ","sponsor":"PTS International Inc.","sponsor_type":"Industry","conditions":"Solid Tumor","interventions":[{"intervention_type":"Drug","name":"Drug: Para-toluenesulfonamide Injection (PTS)","description":"Intratumoral injection"}],"outcomes":[{"outcome_type":"primary","measure":"Maximum tolerable dose","time_frame":"4 weeks post-treatment","description":"Maximum tolerable dose"}]}
{"nct_id":"NCT03460990","start_date":"2018-05-01","phase":"Phase 3","enrollment":116,"brief_title":"A Study of VX-659 Combination Therapy in CF Subjects Homozygous for F508del (F/F)","official_title":"A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F)","primary_completion_date":"2018-09-26","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-10-08","last_update":"2019-10-17","description":"This study will evaluate the efficacy of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation (F/F).","other_id":"VX17-659-103","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":12,"population":"","criteria":"\n        Key Inclusion Criteria:\r\n\r\n          -  Homozygous for the F508del mutation (F/F)\r\n\r\n          -  Forced expiratory volume in 1 second (FEV1) value 40% and 90% of predicted mean for\r\n             age, sex, and height\r\n\r\n        Key Exclusion Criteria:\r\n\r\n          -  Clinically significant cirrhosis with or without portal hypertension\r\n\r\n          -  Lung infection with organisms associated with a more rapid decline in pulmonary status\r\n\r\n          -  Solid organ or hematological transplantation\r\n\r\n        Other protocol defined Inclusion/Exclusion criteria may apply\r\n      ","sponsor":"Vertex Pharmaceuticals Incorporated","sponsor_type":"Industry","conditions":"Cystic Fibrosis","interventions":[{"intervention_type":"Drug","name":"Drug: VX-659/TEZ/IVA","description":"Participants received VX-659/TEZ/IVA orally once daily in the morning."},{"intervention_type":"Drug","name":"Drug: TEZ/IVA","description":"Participants received TEZ/IVA orally once daily in the morning."},{"intervention_type":"Drug","name":"Drug: IVA","description":"Participants received IVA orally once daily in the evening."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Participants received placebo matched TEZ/IVA orally once daily in the morning."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Participants received placebo matched to VX-659/TEZ/IVA orally once daily in the morning."}],"outcomes":[{"outcome_type":"primary","measure":"Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)","time_frame":"From Baseline at Week 4","description":"FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration."},{"outcome_type":"secondary","measure":"Absolute Change in Sweat Chloride (SwCl)","time_frame":"From Baseline at Week 4","description":"Sweat samples were collected using an approved collection device."},{"outcome_type":"secondary","measure":"Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score","time_frame":"From Baseline at Week 4","description":"The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life."},{"outcome_type":"secondary","measure":"Safety and Tolerability as Assessed Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)","time_frame":"From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to Week 8)"},{"outcome_type":"secondary","measure":"Observed Pre-Dose Concentration (Ctrough) of VX-659, TEZ, TEZ Metabolite (M1-TEZ), and IVA","time_frame":"From Day 1 and Week 4"}]}
{"nct_id":"NCT03745521","start_date":"2018-05-01","enrollment":240,"brief_title":"Study of Longitudinal Observation for Patient With X-linked Hypophosphatemic Rickets/Osteomalacia in Collaboration With Asian Partners","official_title":"An International, Multicenter, Prospective, Longitudinal Observational Study for Patient With X-linked Hypophosphatemic Rickets/Osteomalacia","primary_completion_date":"2023-12-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2023-12-31","last_update":"2021-02-04","description":"Through observation of patients with X-linked hypophosphatemic rickets/osteomalacia (XLH) for up to 5 years, the study intends to collect data that allow achievement of the following objectives: 1. To determine medical characteristics of the disease and the disease process 2. To determine physical and psychological burden on patients as well as economic burden 3. To assess the efficacy and safety of the treatment of the disease","other_id":"SUNFLOWER","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","population":"Patients with XLH independent of treatment regimen","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients must meet at least one of the following:\r\n\r\n               1. Documented PHEX gene mutation\r\n\r\n               2. Documented PHEX gene mutation in at least one family member with X-linked genetic\r\n                  relationship\r\n\r\n               3. Documented FGF23 >30 pg/mL\r\n\r\n          -  Typical clinical findings of rickets/osteomalacia\r\n\r\n          -  Written informed consent obtained from patients aged >=20 years or from parents or\r\n             legally acceptable representatives of patients aged <20 years\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Participation in any clinical study (trial) at the time of informed consent\r\n\r\n          -  Any patient whose participation in the study is considered inappropriate by the\r\n             investigator or the subinvestigator\r\n      ","sponsor":"Kyowa Kirin Co., Ltd.","sponsor_type":"Industry","conditions":"X-Linked Hypophosphatemia","interventions":[{"intervention_type":"Other","name":"Other: no intervention","description":"no intervention"}],"outcomes":[{"outcome_type":"primary","measure":"Height","time_frame":"After enrollment, patients will be observed annually or every 2 years for up to 5 years.","description":"Height in centimeters"},{"outcome_type":"primary","measure":"The 6-Minutes Walking Test","time_frame":"After enrollment, patients will be observed annually for up to 5 years.","description":"The 6-Minutes Walking Test performed according to International Guidelines, will be measured as distance in meters."},{"outcome_type":"primary","measure":"Timed Up and Go Test(TUGT)","time_frame":"After enrollment, patients will be observed every 2 years for up to 5 years.","description":"The time required for each patient to do the TUGT will be recorded: Stand up from sitting in a chair, walk 3 meters, turn around, walk back, and sit down."},{"outcome_type":"secondary","measure":"Fracture","time_frame":"5 years","description":"Incidence of fracture of all parts"},{"outcome_type":"secondary","measure":"Radiography","time_frame":"After enrollment, patients will be observed annually or every 2 years for up to 5 years.","description":"Radiography of the sites listed below will be performed. AP views of both knees, PA vies of both wrists, and both long legs. Sites with symptoms such as pain, sites of suspected fracture, and spine (cervical, thoracic and lumber)."},{"outcome_type":"secondary","measure":"Nephrocalcinosis","time_frame":"After enrollment, patients will be observed annually or every 2 years for up to 5 years.","description":"The renal ultrasound will be performed and the presence and/or progression of nephrocalcinosis will be measured."}]}
{"nct_id":"NCT02632552","start_date":"2018-05-01","phase":"N/A","enrollment":600,"brief_title":"A Technology Assisted Care Transition Intervention for Veterans With CHF or COPD","official_title":"A Technology-Assisted Care Transition Intervention for Veterans With Chronic Heart Failure or Chronic Obstructive Pulmonary Disease","primary_completion_date":"2020-06-30","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2021-08-31","last_update":"2021-03-09","description":"Transition from hospital to home places patients in jeopardy of adverse events and increases their risk for rehospitalization. CHF is the most prevalent chronic condition among U.S. adults and COPD is the third leading cause of death in the U.S. Both CHF and COPD represent significant burdens for the VHA healthcare system. Care transitions can be supported through multi-component interventions, but are costly to implement. Virtual nurses provide an effective medium for explaining health concepts to patients, and previous work indicates patients find virtual nurses acceptable. The investigators will implement and evaluate a virtual nurse intervention to provide automated, tailored, and timely support to Veterans transitioning from hospital to home. As effective care transition interventions incorporate both inpatient and outpatient components, the virtual nurse will first engage with patient onscreen during their inpatient stay and then via text message post-discharge. This project has the potential to improve the care transition experience for patients, caregivers and healthcare providers.","other_id":"IIR 15-101","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Veterans\r\n\r\n          -  Diagnosis of chronic heart failure or chronic obstructive pulmonary disease\r\n\r\n          -  Admission to a general medical service\r\n\r\n          -  Able and willing to engage with touchscreen technology\r\n\r\n          -  Have a text-enabled cellular phone to receive the post-discharge text messages\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Not Veterans\r\n\r\n          -  Not diagnosed of chronic heart failure or chronic obstructive pulmonary disease\r\n\r\n          -  Not admitted to a general medical service\r\n\r\n          -  Not capable of using touchscreen technology\r\n\r\n          -  Do not have a text-enabled cellular phone\r\n      ","sponsor":"VA Office of Research and Development","sponsor_type":"U.S. Fed","conditions":"CHF|COPD","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Technology-assisted care transition intervention","description":"In-patient virtual nurse on-screen touchscreen and outpatient virtual nurse follow-up by texting"},{"intervention_type":"Behavioral","name":"Behavioral: Active attention control","description":"In-patient brief animated power-point style didactic onscreen tutorial covering the core pillars of care transitions and brief outpatient texting"}],"outcomes":[{"outcome_type":"primary","measure":"Pre-post change in urgent care service utilization","time_frame":"Within six months","description":"Change in urgent care service utilization between intervention and control groups"},{"outcome_type":"secondary","measure":"30-day sustained community tenure","time_frame":"Within 30 days","description":"Sustained community tenure compared between the intervention and control groups post-intervention"},{"outcome_type":"secondary","measure":"30-day urgent care utilization","time_frame":"Within 30 days","description":"30-day urgent care utilization compared between the intervention and control groups post-intervention"}]}
{"nct_id":"NCT03428308","start_date":"2018-04-30","phase":"N/A","enrollment":90,"brief_title":"Detection and Treatment of Somatic Disease in Patients With Severe Mental Disease","official_title":"Detection and Treatment of Selected Somatic Chronic Diseases in Patients With Severe Mental Disease: Development and Testing of a Coordinated Interdisciplinary and Intersectoral Intervention","primary_completion_date":"2019-04-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-12-31","last_update":"2018-02-09","description":"In Denmark, around 2 % of the population live with severe mental disease. People with severe mental disease live 15-20 years less than the general population. The majority of the years of life lost are a consequence of the excess mortality due to somatic disease. The high prevalence of somatic disease among people with severe mental disease can be largely attributed to physical inactivity, unhealthy diet and side effects from psychopharmacological drugs. Apart from the impacts of unhealthy lifestyle and medication side effects, research suggests that individuals with severe mental disease do not receive the same treatment for their somatic diseases as do the rest of the population. The inequality in diagnostics and treatment can be attributed to stigmatization from healthcare providers and patients' lacking awareness of symptoms and reluctance to seek medical care. Further, the increasing specialization within both somatic and psychiatric care has led to a division between these two treatment systems (8,9). Patients with severe mental disease who simultaneously have one or more somatic diseases need their treatment to be coordinated; such treatment should span general practice, the municipality and the psychiatric and somatic hospital. Accordingly, the following elements are necessary to create effective and coordinated treatment trajectories: detailed preparation, qualitative process evaluation as an integrated part of the courses of treatment, and involvement of all stakeholders from the start. The overall aim of the project is to optimize the detection of selected chronic somatic diseases, including cardiovascular disease (ischaemia and heart failure), diabetes, hypertension and high cholesterol, in individuals with schizophrenia, schizoaffective disorder or bipolar disorder; to initiate medical treatment; and to ensure treatment compliance among patients. Accordingly, the project has the following objectives: - To develop an intervention targeting individuals with schizophrenia, schizoaffective disorder or bipolar disorder that can optimize the detection of selected chronic somatic diseases, including cardiovascular disease (ischaemia and heart failure), diabetes, hypertension and high cholesterol - To test whether the developed intervention can optimize the detection of cardiovascular disease (ischaemia and heart failure), diabetes, hypertension and high cholesterol in individuals with schizophrenia, schizoaffective disorder or bipolar disorder The project's hypotheses are that an interdisciplinary and intersectoral intervention targeting individuals with schizophrenia, schizoaffective disorder or bipolar disorder can - optimize detection of cardiovascular diseases (ischaemia and cardiac insufficiency), diabetes, hypertension and high cholesterol by systematic screening in general practice - lead to initiation and maintenance of relevant medical treatment. Moreover, we hypothesize that the complete intervention in a long-term perspective will lead to decreased mortality within the target group.","other_id":"CSU-2017-002","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Screening","masking_description":"None (Open Label)","intervention_model_description":"Patients who meet the inclusion criteria will be identified and invited to participate by their general practitioner. Patients who agree to partcipate will be invited to a screening consultation focusing on selected somatic diseases. Patients who are diagnosed with one or more of the selected somatic diseases will be included in the intervention, which consists of individualized courses of treatment focusing on initiation and maintenance of medical treatment and complying with current clinical guidelines and course programmes. The intervention is planned to run for one year.","sampling_method":"","gender":"All","minimum_age":36,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Patients who appear in their individual general practitioner's record system with one of\r\n        the following diagnoses:\r\n\r\n          -  Schizophrenia (ICPC code p72)\r\n\r\n          -  Psychosis-schizoaffective disorder without specification (ICPC code p72)\r\n\r\n          -  Bipolar disorder (ICPC code p73)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Persons who live in one of the Municipality of Copenhagen's social-psychiatric\r\n             residences\r\n\r\n          -  Persons with life-threatening disease\r\n\r\n          -  Persons who do not understand and/or speak the Danish language\r\n\r\n          -  Persons with acute suicidal ideation\r\n\r\n          -  Persons with a severe current abuse incompatible with participation\r\n\r\n          -  Persons who are assessed as being a threat to staff\r\n      ","sponsor":"Intersectoral Research Unit for Health Services","sponsor_type":"Other","conditions":"Ischemia|Cardiac Insufficiency|Diabetes Mellitus, Type 2|Hypertension|Hypercholesterolemia|Severe Mental Disorder","interventions":[{"intervention_type":"Other","name":"Other: Screening","description":"Each individual general practitioner reviews his/her record system and detects patients who meet the inclusion criteria. Patients who meet these criteria will be invited to participate in the project."},{"intervention_type":"Other","name":"Other: Treatment","description":"Patients who are diagnosed with one or more of the selected somatic diseases receive an individualized course of treatment in general practice, primarily focusing on initiation and maintenance of medical treatment, and complying with current clinical guidelines and course programmes. Treatment goals are set in active co-operation with the patient and his/her family and with supervision and support from the Mental Health Centre Copenhagen, clinical pharmacologists and relevant staff from the municipality in terms of contact/support persons."}],"outcomes":[{"outcome_type":"primary","measure":"Identified patients with mental disease","time_frame":"Baseline","description":"Proportion of individuals identified with the selected mental diseases from the general practitioner's total population"},{"outcome_type":"primary","measure":"Patients attending screening","time_frame":"Baseline","description":"Proportion of individuals who attend screening out of the total population of individuals who indicate via telephone their wish to participate"},{"outcome_type":"primary","measure":"Patients diagnosed with somatic disease","time_frame":"Baseline","description":"Proportion of screened individuals who are diagnosed with one or more of the selected somatic diseases"},{"outcome_type":"primary","measure":"Patients with untreated somatic disease","time_frame":"Baseline","description":"Proportion of screened individuals in whom untreated somatic disease is identified"},{"outcome_type":"primary","measure":"Number of follow-up visits","time_frame":"One year","description":"Number of follow-up visits for participants in whom medical treatment of somatic disease has been initiated is compared with number of visits in general practice the year before the intervention"},{"outcome_type":"secondary","measure":"Appropriateness of medical treatment","time_frame":"One year","description":"Whether the patients' medical treatment is appropriate is assessed using the Medication Appropriateness Index (MAI)"},{"outcome_type":"secondary","measure":"Change in HbA1c (blood test)","time_frame":"One year","description":"Assessment of change in HbA1c since baseline for the participants for whom medical treatment has been initiated"},{"outcome_type":"secondary","measure":"Change in body weight","time_frame":"One year","description":"Assessment of change in body weight (kilograms) since baseline for the participants for whom medical treatment has been initiated"},{"outcome_type":"secondary","measure":"Change in blood pressure","time_frame":"One year","description":"Assessment of change in blood pressure (mmHg) since baseline for the participants for whom medical treatment has been initiated"},{"outcome_type":"secondary","measure":"Change in blood cholesterol (blood test)","time_frame":"One year","description":"Assessment of change in blood cholesterol since baseline for the participants for whom medical treatment has been initiated"},{"outcome_type":"other","measure":"Success of inclusion criteria","time_frame":"One year","description":"Qualitative interviews with clinicians will be done to assess the success of the inclusion criteria."},{"outcome_type":"other","measure":"Success of exclusion criteria","time_frame":"One year","description":"Qualitative interviews with clinicians will be done to assess the success of the exclusion criteria."},{"outcome_type":"other","measure":"Success of initiatives for recruiting patients","time_frame":"One year","description":"Qualitative interviews with clinicians and municipal contact/support persons will be done to assess the success of the process in incentivizing participants to attend screening and subsequent follow-up visits.\r\nData registration sheets on attendance and telephonic contact with participants will be evaluated."},{"outcome_type":"other","measure":"Success of screening and treatment","time_frame":"One year","description":"Qualitative interviews with clinicians and municipal contact/support persons will be done to assess the success of the process in screening and treating the target individuals in general practice"},{"outcome_type":"other","measure":"Individual benefits","time_frame":"One year","description":"Qualitative interviews with clinicians, municipal contact/support persons and participants will be done to assess which individuals benefited from the intervention and which did not."},{"outcome_type":"other","measure":"Circumstances for success","time_frame":"One year","description":"Qualitative interviews with clinicians, municipal contact/support persons and participants will be done to assess the circumstances under which the intervention succeeded."},{"outcome_type":"other","measure":"Success of intersectoral cooperation","time_frame":"One year","description":"Qualitative interviews with clinicians, municipal contact/support persons, psychiatrists, clinical pharmacologists and participants will be done to assess how the intersectoral cooperation functioned."}]}
{"nct_id":"NCT03494335","start_date":"2018-04-30","phase":"N/A","enrollment":5000,"brief_title":"Online Surveys to Assess the Perception and Performance of Imaging and Associated Aspects","official_title":"Online Surveys to Assess the Perception and Performance of Imaging Associated Aspects","primary_completion_date":"2020-04-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2021-04-30","last_update":"2018-04-11","description":"In this exploratory study, we would like to investigate the background, perception, current use practices, potential unmet needs and/or challenges in regard to imaging procedures, imaging technology, or any other aspect related to the broader field of imaging.","other_id":"RP0320_S02/2018E0141","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Health Services Research","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male and female participants who have access to the online survey tool and can read\r\n             and write in English\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  None, as this is voluntary\r\n      ","sponsor":"Ohio State University","sponsor_type":"Other","conditions":"Perception of Imaging","interventions":[{"intervention_type":"Other","name":"Other: Online surveys","description":"We are targeting health care providers for these surveys that are involved in or use imaging."}],"outcomes":[{"outcome_type":"primary","measure":"Perception of PET/CT imaging agent Y-90","time_frame":"through study completion, on average 2-5 years","description":"Responses to online surveys assessing participants' perceptions of Y-90 will be analyzed"},{"outcome_type":"primary","measure":"Perception of PET/CT imaging agent NaF","time_frame":"through study completion, on average 2-5 years","description":"Responses to online surveys assessing participants' perceptions of NaF will be analyzed"},{"outcome_type":"primary","measure":"Perception of MRI contrast agents","time_frame":"through study completion, on average 2-5 years","description":"Responses to online surveys assessing participants' perceptions of MR contrast agents will be analyzed"}]}
{"nct_id":"NCT03237897","start_date":"2018-04-30","enrollment":0,"brief_title":"Evaluation of a Preoperative Education Class for Colorectal Surgery Patients","official_title":"Evaluation of a Preoperative Education Class for Colorectal Surgery Patients","primary_completion_date":"2019-04-30","study_type":"Observational","rec_status":"Withdrawn","completion_date":"2019-11-30","last_update":"2018-03-27","description":"The purpose of the study is to evaluate the value and effectiveness of a newly-implemented preoperative education class for patients undergoing colorectal surgery.","other_id":"07-16-05E","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":90,"population":"The study population will include only patients scheduled to undergo colorectal surgical\r\n        procedures at CMC-Main.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Scheduled to undergo surgical operations of the colon or rectum at Carolinas Medical\r\n             Center Main\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  A medical condition, laboratory finding, or physical exam finding that precludes\r\n             participation\r\n\r\n          -  Develop a significant intra- or postoperative complication that precludes or delays\r\n             participation for longer than 4 weeks; or\r\n\r\n          -  Have anything that would place the individual at increased risk or preclude the\r\n             individual's full compliance with or completion of the study.\r\n      ","sponsor":"Atrium Health","sponsor_type":"Other","conditions":"Colorectal Surgery","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Pedometer","description":"A pedometer will be affixed to patients in the immediate postoperative period and removed at time of discharge"},{"intervention_type":"Behavioral","name":"Behavioral: Preoperative education class","description":"The preoperative enhanced recovery after surgery education class will be offered twice a week in coordination with anesthesia preoperative appointments to minimize inconvenience for patients. Patients will need to attend only one class. All participants will be offered the class. This class will be one hour in duration and will be taught by a surgical advanced care practitioner familiar with the details of colorectal surgery. The class will include detailed information about preoperative care, intraoperative care, and postoperative care."}],"outcomes":[{"outcome_type":"primary","measure":"Time to ambulation","time_frame":"from time of surgery until the time of first documented ambulation, assessed up to 90 days","description":"time to first ambulation following surgery measured by pedometer and notations made by nursing staff in the patient records prior to patient discharge."},{"outcome_type":"primary","measure":"Mean number of steps","time_frame":"from time of surgery until the time of discharge, up to 90 days","description":"mean number of steps taken daily as measured by pedometer"},{"outcome_type":"secondary","measure":"Knowledge level","time_frame":"date of preoperative education class (up to 2 weeks prior to time of surgery) and date of first postoperative follow-up appointment (up to 90 days following surgery)","description":"Knowledge level assessed by knowledge survey administered to patients"},{"outcome_type":"secondary","measure":"Patient anxiety level","time_frame":"date of enrollment and date of discharge, up to 90 days following surgery","description":"Patient anxiety level assessed by anxiety survey administered to patients"},{"outcome_type":"secondary","measure":"Patient satisfaction score","time_frame":"date of first postoperative follow-up appointment, up to 90 days following surgery","description":"Patient satisfaction score assessed by satisfaction survey administered to patients"},{"outcome_type":"secondary","measure":"30-day readmission rate","time_frame":"30 days following surgery"},{"outcome_type":"secondary","measure":"Inpatient length of stay","time_frame":"from date of surgery until the date of discharge, up to 90 days","description":"Inpatient length of stay measured in number of days"}]}
{"nct_id":"NCT03509948","start_date":"2018-04-27","phase":"Phase 1","enrollment":13,"brief_title":"A Study in Healthy Smokers to Investigate the Effect of Food on the Bioavailability of Cytisine in a New Formulation","official_title":"A Phase 1 Open Label, Randomized, Two-Way Crossover Study in Healthy Smokers to Investigate the Effect of Food on the Bioavailability of Cytisine in a New Formulation","primary_completion_date":"2018-06-10","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-06-12","last_update":"2019-09-24","description":"This will be an open-label, randomised, 2-treatment period, single-dose crossover study to determine the comparative bioavailability and renal elimination following single-dose administration of 3.0 mg cytisine in healthy smokers under fed and fasted conditions.","other_id":"ACH-CYT-07","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        To be Confirmed at Screening\r\n\r\n          1. Subject is current cigarette smoker.\r\n\r\n          2. Healthy males and females between 18 and 55 years of age.\r\n\r\n               1. If a female subject of child bearing potential, a negative pregnancy test at\r\n                  screening and admission and willing to use an effective method of contraception\r\n                  (unless of non-childbearing potential or where abstaining from sexual intercourse\r\n                  is in line with the preferred and usual lifestyle of the subject) from first dose\r\n                  until 3 months after last dose of cytisine.\r\n\r\n               2. If a female subject of non-child bearing potential, a negative pregnancy test at\r\n                  screening and admission. For the purposes of this study, this is defined as the\r\n                  subject being amenorrheic for at least 12 consecutive months or at least 4 months\r\n                  post-surgical sterilisation (including bilateral fallopian tube ligation or\r\n                  bilateral oophorectomy with or without hysterectomy). Menopausal status will be\r\n                  confirmed by demonstrating at screening that levels of follicle stimulating\r\n                  hormone (FSH) fall within the respective pathology reference range. In the event\r\n                  a subject's menopause status has been clearly established (for example, the\r\n                  subject indicates she has been amenorrheic for 10 years), but FSH levels are not\r\n                  consistent with a post-menopausal condition, determination of subject eligibility\r\n                  will be at Investigator's discretion following consultation with the Sponsor.\r\n\r\n               3. If a male subject, willing to use an effective method of contraception (unless\r\n                  anatomically sterile or where abstaining from sexual intercourse is in line with\r\n                  the preferred and usual lifestyle of the subject) from first dose until 3 months\r\n                  after last dose of cytisine.\r\n\r\n          3. Subject with a body mass index (BMI) of 23-28 kg/m^2. BMI = body weight in kg /\r\n             [height in m^2].\r\n\r\n          4. Subject with no clinically significant abnormal serum biochemistry or haematology\r\n             values within 28 days before the first dose of cytisine.\r\n\r\n          5. Subject with negative urinary drugs of abuse screen, determined within 28 days before\r\n             the first dose of cytisine (a positive result may be repeated at Investigator's\r\n             discretion).\r\n\r\n          6. Subject with negative human immunodeficiency virus (HIV), hepatitis B surface antigen\r\n             (Hep B) and hepatitis C virus antibody (Hep C) results.\r\n\r\n          7. Subject with no clinically significant abnormalities in 12-lead ECG determined after\r\n             minimum of 5 minutes in supine position within 28 days before the first dose of\r\n             cytisine.\r\n\r\n          8. Subject with no clinically significant abnormalities in vital signs (systolic blood\r\n             pressure between 90-140 mmHg, diastolic blood pressure (DBP) between 50 and 90 mmHg,\r\n             and pulse rate (PR) between 40-100 bpm, measured on the dominant arm after minimum of\r\n             5 minutes in supine position) determined within 28 days before first dose of cytisine.\r\n\r\n          9. Subject must be available to complete the study (including post study follow-up) and\r\n             comply with study restrictions.\r\n\r\n         10. Subject must provide written informed consent to participate in the study.\r\n\r\n        To be Re-Confirmed Prior to Dosing\r\n\r\n          1. Subject continues to meet all screening inclusion criteria (before the cytisine dose).\r\n\r\n          2. Subject has a negative urinary drugs of abuse screen (including alcohol).\r\n\r\n          3. Female subject has a negative urine pregnancy test.\r\n\r\n        Exclusion Criteria:\r\n\r\n        To be Confirmed at Screening\r\n\r\n          1. Known hypersensitivity/allergy reaction to varenicline, other cytisine-derivatives or\r\n             any of the excipients in the Tabex formulation (cellulose, talc, magnesium).\r\n\r\n          2. History of severe hypersensitivity reactions to any other drugs.\r\n\r\n          3. History of any medical condition (e.g. gastrointestinal, renal or hepatic) or surgical\r\n             condition (e.g. cholecystectomy, gastrectomy) that may affect drug pharmacokinetics\r\n             (absorption, distribution, metabolism or excretion).\r\n\r\n          4. Female subjects who are breast feeding.\r\n\r\n          5. Difficulty in donating blood on either arm or known history.\r\n\r\n          6. History of alcoholism or drug abuse within last 2 years.\r\n\r\n          7. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary\r\n             supplements within 14 days (or 5 half-lives, whichever is longer) prior to the\r\n             cytisine dose, unless in the opinion of the Investigator the medication will not\r\n             interfere with the study procedures or compromise subject safety.\r\n\r\n          8. Participated in any investigational drug clinical trial within the previous 3 months\r\n             or a marketed drug trial within the previous 30 days prior to randomization on Day 1\r\n             of Period 1.\r\n\r\n          9. Donation of 450 mL or more blood or had history of significant blood loss due to any\r\n             reason or had plasmapheresis within 3 months before the cytisine dose.\r\n\r\n         10. Any inability or difficulty in fasting.\r\n\r\n         11. Inability to communicate well with Investigators (i.e., language problem, poor mental\r\n             development or impaired cerebral function).\r\n\r\n         12. Any other condition that the Principal Investigator considers making the subject\r\n             unsuitable for this study.\r\n\r\n        To be Re-Confirmed Prior to Dosing:\r\n\r\n          1. Development of any exclusion criteria since screening.\r\n\r\n          2. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary\r\n             supplements since screening, unless in the opinion of the Investigator the medication\r\n             will not interfere with the study procedures or compromise subject safety.\r\n\r\n          3. Participation in a clinical study since the screening visit.\r\n\r\n          4. Donation of 450 mL or more blood since the screening visit.\r\n      ","sponsor":"Achieve Life Sciences","sponsor_type":"Industry","conditions":"Smoking Cessation","interventions":[{"intervention_type":"Drug","name":"Drug: cytisine","description":"cytisine 1.5 mg film-coated tablets"}],"outcomes":[{"outcome_type":"primary","measure":"Maximum Concentration (Cmax)","time_frame":"Pre-dose (within 60 minutes prior to dosing), up to 48 hours post-dose on Days 1-5"},{"outcome_type":"primary","measure":"Area Under the Concentration Versus Time Curve (AUC) Extrapolated to Infinity (AUC0-∞)","time_frame":"Pre-dose (within 60 minutes prior to dosing) up to 48 hours post dose on Days 1-5"},{"outcome_type":"primary","measure":"Total Cytisine Excreted in Urine Over 48 Hours (Ae0-48h)","time_frame":"Pre-dose (within 60 minutes prior to dosing) up to 48 hours post dose on Days 1-5"},{"outcome_type":"primary","measure":"Percent of Total Cytisine Excreted in Urine Over 48 Hours (Ae0-48h%)","time_frame":"Pre-dose (within 60 minutes prior to dosing) up to 48 hours post dose on Days 1-5"},{"outcome_type":"secondary","measure":"Time to Cmax (Tmax)","time_frame":"Pre-dose (within 60 minutes prior to dosing) up to 48 hours post dose on Days 1-5"},{"outcome_type":"secondary","measure":"Terminal Elimination Half-Life (T1/2)","time_frame":"Pre-dose (within 60 minutes prior to dosing) up to 48 hours post dose on Days 1-5"},{"outcome_type":"secondary","measure":"AUC From Time of Dosing to Last Measurable Concentration (AUC0-t)","time_frame":"Pre-dose (within 60 minutes prior to dosing) up to 48 hours post dose on Days 1-5"},{"outcome_type":"secondary","measure":"Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Withdrawal of Study Drug","time_frame":"Baseline (Day 0) through Day 5 plus 6-8 days","description":"An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) is defined as an AE that: results in death; is life-threatening; requires hospitalization or prolongs existing inpatient hospitalization; results in persistent or significant disability or incapacity; results in a congenital abnormality or birth defect; is an important medical event which requires medical intervention to prevent any of the above outcomes. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product. Relationship of the TEAE to study drug was evaluated as: definite, probably, possible, unlikely, or not related."},{"outcome_type":"secondary","measure":"Number of Participants With Clinically Significant Biochemistry, Hematology, Urinalysis, and/or 12-lead Electrocardiogram (ECG) Values","time_frame":"Screening through Day 5"}]}
{"nct_id":"NCT03170219","start_date":"2018-04-27","phase":"Phase 2","enrollment":11,"brief_title":"Subcutaneous Furosemide in Acute Decompensated Heart Failure: The SUBQ-HF Study","official_title":"Subcutaneous Furosemide in Acute Decompensated Heart Failure: The SUBQ-HF Study","primary_completion_date":"2018-09-20","study_type":"Interventional","rec_status":"Terminated","completion_date":"2018-09-20","last_update":"2019-01-23","description":"To determine if a strategy of early discharge using a novel subcutaneous delivery system for parenteral furosemide can improve clinical outcomes within 30 days of randomization (days alive and outside the hospital) compared to usual care.","other_id":"Pro00070619","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria for Pathway 1 (patients hospitalized with acute heart failure)\r\n\r\n          1. Age >18 years\r\n\r\n          2. Willingness and ability to provide informed consent\r\n\r\n          3. Hospitalization for AHF with at least 1 symptom (dyspnea, orthopnea, or edema) AND 1\r\n             sign (rales on auscultation, peripheral edema, ascites, pulmonary vascular congestion\r\n             on chest radiography, BNP > 250 ng/mL or NTproBNP > 1000 ng/mL) of congestion\r\n\r\n          4. Persistent congestion defined by the presence of at least 2 or more of the following\r\n             at the time of consent:\r\n\r\n               1. Peripheral edema\r\n\r\n               2. Rales\r\n\r\n               3. Elevated JVP\r\n\r\n               4. Ascites\r\n\r\n               5. BNP > 250 ng/mL or NTproBNP > 1000 ng/mL during index hospitalization\r\n\r\n               6. Orthopnea\r\n\r\n          5. Total anticipated daily IV furosemide dose (at time of screening) >80-240 mg (or\r\n             equivalent)/day\r\n\r\n          6. Anticipated need for at least 24 more hours of parenteral diuretic therapy\r\n\r\n        Exclusion Criteria for Pathway 1\r\n\r\n          1. Severe renal dysfunction (eGFR< 20 ml/min/1.73m2) within 24 hours of enrollment\r\n\r\n          2. Requirement for inotropes (other than digoxin) or mechanical support during\r\n             hospitalization\r\n\r\n          3. Clinically significant electrical instability during hospitalization\r\n\r\n          4. Anticipated need for ongoing intravenous therapies beyond diuretics (electrolyte\r\n             repletion, vasodilators, antibiotics, etc.)\r\n\r\n          5. Planned discharge to location other than home (e.g., hospice, skilled nursing\r\n             facility, etc.)\r\n\r\n          6. Anticipated cardiac transplantation or left ventricular assist device within the next\r\n             30 days\r\n\r\n          7. Primary hypertrophic cardiomyopathy, infiltrative cardiomyopathy, acute myocarditis,\r\n             constrictive pericarditis or tamponade\r\n\r\n          8. Known or anticipated pregnancy in the next 30 days\r\n\r\n          9. Prior use of a subcutaneous furosemide pump or current use of any subcutaneous pump,\r\n             on-body infusion devices or patients who give regimented injections at the intended\r\n             site of the furosemide infusion device.\r\n\r\n         10. Other psychosocial or physical barriers to following the protocol and using SQ pump\r\n             device outside the hospital setting\r\n\r\n         11. Known allergy to furosemide\r\n\r\n         12. Known sensitivity or allergy to medical adhesive tape\r\n\r\n         13. Enrollment or planned enrollment in another therapeutic clinical trial in next 3\r\n             months\r\n\r\n         14. Presentation is for indication other than CHF\r\n\r\n        Inclusion Criteria for Pathway 2 (Outpatients with heart failure presenting with volume\r\n        overload necessitating treatment with parenteral loop diuretics)\r\n\r\n          1. Age >18 years\r\n\r\n          2. Willingness and ability to provide informed consent\r\n\r\n          3. HF now presenting with volume overload defined by the presence of at least 2 or more\r\n             of the following at the time of consent:\r\n\r\n               1. Peripheral edema\r\n\r\n               2. Rales\r\n\r\n               3. Elevated JVP\r\n\r\n               4. Ascites\r\n\r\n               5. BNP > 250 ng/mL or NTproBNP > 1000 ng/mL during this episode of decompensation\r\n\r\n               6. Orthopnea\r\n\r\n          4. Need for parenteral furosemide with an estimated SQ furosemide requirement between\r\n             80-240 mg/day\r\n\r\n          5. Anticipated need for at least 24 hours of parenteral diuretic therapy\r\n\r\n        Exclusion Criteria for Pathway 2\r\n\r\n          1. Severe renal dysfunction (eGFR< 20 ml/min/1.73m2) within 24 hours of enrollment\r\n\r\n          2. Anticipated need for inotropes (other than digoxin) or mechanical support to treat\r\n             current episode of decompensation\r\n\r\n          3. Clinically significant electrical instability requiring hospitalization\r\n\r\n          4. Anticipated need for ongoing intravenous therapies beyond diuretics (electrolyte\r\n             repletion, vasodilators, antibiotics, etc.)\r\n\r\n          5. Residence at location other than home (e.g., hospice, skilled nursing facility, etc.)\r\n\r\n          6. Anticipated cardiac transplantation or left ventricular assist device within the next\r\n             30 days\r\n\r\n          7. Primary hypertrophic cardiomyopathy, infiltrative cardiomyopathy, acute myocarditis,\r\n             constrictive pericarditis or tamponade\r\n\r\n          8. Known or anticipated pregnancy in the next 30 days\r\n\r\n          9. Prior use of a subcutaneous furosemide pump or current use of any subcutaneous pump,\r\n             on-body infusion devices or patients who give regimented injections at the intended\r\n             site of the furosemide infusion device.\r\n\r\n         10. Other psychosocial or physical barriers to following the protocol and using SQ pump\r\n             device outside the hospital setting\r\n\r\n         11. Known allergy to furosemide\r\n\r\n         12. Known sensitivity or allergy to medical adhesive tape\r\n\r\n         13. Enrollment or planned enrollment in another therapeutic clinical trial in next 3\r\n             months.\r\n\r\n         14. Presentation is for indication other than CHF.\r\n      ","sponsor":"Adrian Hernandez","sponsor_type":"Other","conditions":"Acute Heart Failure|Decompensated Heart Failure","interventions":[{"intervention_type":"Combination Product","name":"Combination Product: subcutaneous furosemide and sc2wear device","description":"subcutaneous furosemide administered via sc2wear device vs. standard of care"}],"outcomes":[{"outcome_type":"primary","measure":"Patient Safety Measured by Serious Adverse Events","time_frame":"30 days","description":"measured by serious adverse events"},{"outcome_type":"secondary","measure":"Composite Safety Endpoint of Death, Sustained Ventricular Arrhythmias, and Severe Hypokalemia","time_frame":"30 days"},{"outcome_type":"secondary","measure":"Medical Costs From Randomization Through 30 Days","time_frame":"30 days"},{"outcome_type":"secondary","measure":"Days Alive and Outside the Hospital Through 14 Days","time_frame":"14 days"},{"outcome_type":"secondary","measure":"30 Day Heart Failure Readmission","time_frame":"30 days"},{"outcome_type":"secondary","measure":"30 Day ED Visit for Heart Failure","time_frame":"30 days"},{"outcome_type":"secondary","measure":"Death at 30 Days","time_frame":"30 days"},{"outcome_type":"secondary","measure":"Change in Breathlessness Through Day 7","time_frame":"7 days","description":"On a 0-10 scale of breathlessness"},{"outcome_type":"secondary","measure":"Change in Renal Function Using eGFR Baseline to 30 Days","time_frame":"30 days"},{"outcome_type":"secondary","measure":"Change in NT Pro BNP From Baseline to 30 Days","time_frame":"30 days"}]}
{"nct_id":"NCT03242941","start_date":"2018-04-26","phase":"N/A","enrollment":16,"brief_title":"AF Septal Pacing (Clinical Investigation Plan)","official_title":"AF Septal Pacing (Clinical Investigation Plan)","primary_completion_date":"2018-07-20","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-12-21","last_update":"2019-11-04","description":"The purpose of this non-randomized, non-controlled, acute, single-arm research study is to evaluate the feasibility to obtain a stable position of a ring of stimulation electrodes on the interatrial septum. The possibility to terminate atrial arrythmias will also be evaluated.","other_id":"AF Septal Pacing","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Approximately 15 subjects with AF indicated for ablation of the pulmonary vein will be enrolled in the study. Participants will attend the Baseline visit and the Procedure visit. The baseline visit can be on the same day as the ablation procedure. Since it is an acute study, no follow-up visit will occur. The research procedure will be performed during an already scheduled ablation procedure. Subjects will be enrolled over a period of approximately 18 months","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patient referred to the center to undergo ablation of the pulmonary vein using\r\n             radiofrequency (initial AF ablation, or redo procedure).\r\n\r\n          -  In case of paroxysmal AF the right atrium should be dilated as indicated by > 29 ml\r\n             mm2 or the left atrium should be dilated as indicated by > 34 ml mm2.\r\n\r\n          -  Patient is willing and able to cooperate with the study procedure.\r\n\r\n          -  Patient is willing to provide the Informed Consent for their participation in the\r\n             study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients under 18 years or over 80 years old.\r\n\r\n          -  Women who are currently pregnant or have a positive pregnancy test.\r\n\r\n          -  Patients with an implantable cardiac device.\r\n\r\n          -  Patients who already underwent an AF septal ablation procedure.\r\n      ","sponsor":"Medtronic BRC","sponsor_type":"Industry","conditions":"Paroxysmal Atrial Fibrillation|Persistent Atrial Fibrillation","interventions":[{"intervention_type":"Procedure","name":"Procedure: Pulmonary vein ablation","description":"After pulmonary vein isolation, during the routine waiting time of half an hour to confirm efficacy of the ablation, the septal catheter, already in place in right atrium, will be positioned on the interatrial septum. If the patient will not be in sinus rhythm, he/she will be externally cardioverted in order to determine pacing thresholds and impedances on all septal catheter electrodes. Next, atrial fibrillation will be induced by rapid atrial pacing.AF cycle length will be determined in the left atrial appendage, during 1 minute of atrial fibrillation using ablation catheter electrodes. Subsequently, a pacing scheme will be applied and capture on decapolar recording catheters, already in place for the standard ablation procedure will be assessed as well as AF termination."}],"outcomes":[{"outcome_type":"primary","measure":"Number of Electrodes in a Stable Position","time_frame":"30 minutes","description":"To assess Pacing Site Stability, the number of interatrial septal pacing electrodes which are successfully placed in a stable position, will be counted. A stable position in this study is defined as a location where the pacing threshold will be < 10 mA at a pacing pulse width of 1 msec. Stable pacing further requires that no ventricular capture will be induced during atrial stimulation at twice the atrial capture threshold."},{"outcome_type":"secondary","measure":"Localized Atrial Capture","time_frame":"30 minutes","description":"To assess Localized Atrial Capture the following endpoints will be considered:\r\n- the number of AF episodes in which local capture is recorded during atrial septal stimulation in at least one of the electrode positions"},{"outcome_type":"secondary","measure":"Termination of Atrial Tachyarrhythmia.","time_frame":"30 minutes","description":"Termination of atrial tachyarrhythmia."}]}
{"nct_id":"NCT03517228","start_date":"2018-04-24","phase":"N/A","enrollment":40,"brief_title":"Pilot Trial of the Robotic Uterine Manipulator","official_title":"Pilot Trial of the Robotic Uterine Manipulator","primary_completion_date":"2022-04-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-04-30","last_update":"2021-01-22","description":"The purpose of this study is to test a robotic uterine manipulator system called the Barakat Automated Uterine Manipulator (BAUM), which will assist the surgeon in moving and positioning the uterus during a hysterectomy. This new device will allow the surgeon to control the movements of the robotic arm directly instead of giving verbal instructions to a staff member. The BAUM has never been used during surgeries before this trial. Overall, the study goal is to determine whether the use of this robotic uterine manipulator system can be safely used in the operating room while improving surgeon control during the procedure.","other_id":"18-173","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Female participant must be scheduled for a total laparoscopic or robotic-assisted\r\n             hysterectomy for a gynecologic condition\r\n\r\n          -  Female participants must be 18 years of age or older\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Female participant is not eligible if the surgeon does not plan to use a uterine\r\n             manipulator\r\n      ","sponsor":"Memorial Sloan Kettering Cancer Center","sponsor_type":"Other","conditions":"Gynecologic Surgery","interventions":[{"intervention_type":"Device","name":"Device: BAUM device","description":"The robotic manipulator will be placed at the start of each case. The manipulator will be cleaned and sanitized using the same process as other reusable OR devices. Feasibility will be determined by the rate of successful robotic manipulator docking and if the manipulation of the uterus was successful for the duration of the procedure. The V-Care is an FDA approved uterine manipulator which will attach to the investigational BAUM. Placement of a BAUM will be noted on the operative note."}],"outcomes":[{"outcome_type":"primary","measure":"the number of intraoperative complications attributed to the robotic manipulator.","time_frame":"25- 35 days","description":"will be assessed by reporting all intraoperative complications during the surgery. Complications might include vaginal tear or uterine perforation."}]}
{"nct_id":"NCT03656796","start_date":"2018-04-23","phase":"N/A","enrollment":29,"brief_title":"Effects of RAC With Locomotion Training on Cortical Excitability and Behavior in Patients With PD","official_title":"Effects of Rhythmic Auditory Cueing With Locomotion Training on Cortical Excitability and Behavior in Patients With Parkinson's Disease","primary_completion_date":"2018-07-09","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-04-02","last_update":"2019-09-25","description":"In this study, 51 subjects include 17 freezers,17 non-freezers and 17 aged-matched healthy subjects will be recruited. We will compare the cortical excitability, gait performance, and stepping-in-place performance before and after intervention of auditory cues combined with gait training. The cortical excitability will be assessed by transcranial magnetic stimulation (TMS). The purpose in this study is to investigate the effects of auditory cues with gait training on cortical excitability and rhythmic movements in patients with Parkinson's disease.","other_id":"201802068RINC","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Aged above 20 y/o\r\n\r\n          -  Diagnosed with idiopathic Parkinson's disease\r\n\r\n          -  No hearing impairment\r\n\r\n          -  Able to walk independently without aid\r\n\r\n          -  MMSE above 24\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Other neurological disease\r\n\r\n          -  Orthopedic problems affect gait performance\r\n\r\n          -  Psychological disorder\r\n\r\n          -  Unstable cardiovescular and respiratory status\r\n\r\n          -  Dementia\r\n\r\n          -  Visual disturbance affects gait performance\r\n\r\n          -  Contraindication of transcranial magnetic stimulation: family history of epilepsy;\r\n             head injury; head surgery or metal implant; pacemaker; syncope or migraine with\r\n             unknown reasons; pregnancy\r\n      ","sponsor":"National Taiwan University Hospital","sponsor_type":"Other","conditions":"Parkinson's Disease","interventions":[{"intervention_type":"Other","name":"Other: Treadmill training with auditory cues","description":"Participants should walk on the treadmill according to the rhythmic auditory cues (110% step frequency) for 30 min"},{"intervention_type":"Other","name":"Other: Treadmill training without auditory cues","description":"Participants should walk in comfortable speed on the treadmill for 30 min."}],"outcomes":[{"outcome_type":"primary","measure":"Transcranial magnetic stimulation (TMS)","time_frame":"40 min","description":"TMS will be used to evaluate the cortical excitability. TMS parameters include resting motor threshold (RMT), motor evoke potential (MEPs), cortical silent period (CSP), short intracortical inhibition (SICI) and intracortical facilitation (ICF)"},{"outcome_type":"secondary","measure":"10 meter walking test","time_frame":"10 min","description":"The foot sensors is used to measure the coefficient of variance of step time (step time CV), gait velocity, stride length, and cadence."},{"outcome_type":"secondary","measure":"Stepping-in-place test","time_frame":"5 min","description":"The foot sensors are used to measure the stepping variability between each step."}]}
{"nct_id":"NCT03527355","start_date":"2018-04-18","phase":"Phase 2","enrollment":285,"brief_title":"Safety, Reactogenicity and Immunogenicity of Vi-DT;Typhoid Conjugate Vaccine","official_title":"A Phase II, Randomized, Dose-scheduling, Observer-Blinded Study to Assess the Safety, Reactogenicity and Immunogenicity of Vi-DT Conjugate Vaccine in 6-23-Month Old Healthy Filipino Infants and Toddlers","primary_completion_date":"2018-07-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2021-01-19","last_update":"2021-08-27","description":"This is a randomized, observer-blinded Phase 2 study in healthy infants and toddlers 6-23 months of age at the time of the first vaccine dose. The purpose of this study is to assess the safety and immunogenicity of the Vi-DT vaccine in age group 6-23months of age. The Vi-DT vaccine is administered at 25 g either as a single dose, or two doses given 6 months apart.","other_id":"IVI T002","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Quadruple","intervention_model_description":"Participants age 6-23 months","sampling_method":"","gender":"All","minimum_age":0.5,"maximum_age":1.91667,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy infants and children 6-23 months of age at enrollment as determined by medical\r\n             history, physical examination and clinical judgment of the investigator\r\n\r\n          -  Birth weight  2500 g\r\n\r\n          -   37 weeks of pregnancy or judge to be full-term by the midwife or birth attendant\r\n\r\n          -  Parents aged 18 years and above and legal guardians aged 21 years and above as per the\r\n             legal authorization in the Philippines, who have voluntarily given informed consent\r\n\r\n          -  Parents/ legal guardians willing to follow the study procedures of the study and\r\n             available for the entire duration of the study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Child with a congenital abnormality\r\n\r\n          -  Subject with abnormal routine biological values at screening\r\n\r\n          -  Subject concomitantly enrolled or scheduled to be enrolled in another trial\r\n\r\n          -  Acute illness, in particular infectious disease or fever (axillary temperature\r\n             37.5C), within three days prior to enrolment and vaccination\r\n\r\n          -  Known history of immune function disorders including immunodeficiency diseases, or\r\n             chronic use of systemic steroids (>20 mg/day prednisone equivalent for periods\r\n             exceeding 10 days), cytotoxic or other immunosuppressive drugs\r\n\r\n          -  Child with a previously ascertained or suspected disease caused by S. typhi\r\n\r\n          -  Child who have had household contact with/and or intimate exposure to an individual\r\n             with laboratory-confirmed S. typhi\r\n\r\n          -  Known history or allergy to vaccines or other medications\r\n\r\n          -  Know history of allergy to eggs, chicken protein, neomycin and formaldehyde\r\n\r\n          -  History of uncontrolled coagulopathy or blood disorders\r\n\r\n          -  Mother has known HIV infection or other immune function disorders\r\n\r\n          -  Any abnormality or chronic disease which in the opinion of the investigator might be\r\n             detrimental for the safety of the subject and interfere with the assessment of the\r\n             study objectives\r\n\r\n          -  Child whose parents or legal guardian planning to move from the study area before the\r\n             end of study period\r\n      ","sponsor":"International Vaccine Institute","sponsor_type":"Other","conditions":"Typhoid","interventions":[{"intervention_type":"Biological","name":"Biological: Vi-DT","description":"Manufacturer: SK Bioscience Co., Ltd. Ingredient: Purified Vi-polysaccharide conjugated to diphtheria toxoid Dose: 0.5 mL/Vial"},{"intervention_type":"Biological","name":"Biological: FluQuadri","description":"Manufacturer: Sanofi Pasteur Dose: 0.25 ml\r\n*Participants who have not been vaccinated for flu before, will receive a second dose of flu-vaccine after unblinding."},{"intervention_type":"Other","name":"Other: 0.9% sodium chloride isotonic solution","description":"Manufacture: Euro-Med Inc. Dose: 0.5 mL"}],"outcomes":[{"outcome_type":"primary","measure":"Safety endpoints: solicited and unsolicited adverse events and serious adverse events","time_frame":"Solicited AE: during 7 days after each vaccination. Unsolicited AE: after the first vaccination until 4 weeks after the second vaccination. SAE will be captured after the first vaccination up to week 100 for Group A, week 96 for Group B, week 36 Group C","description":"Frequency (percentage) of solicited local reactions at the injection site: Pain, tenderness, erythema/redness, swelling/induration and pruritus local\r\nFrequency (percentage) of solicited systemic reactions: Fever, lethargy, irritability, vomiting, diarrhea, drowsiness, loss of appetite, persistent crying, rash and nasopharyngitis\r\nFrequency (percentage) of unsolicited adverse events\r\nFrequency (percentage) of serious adverse events"},{"outcome_type":"secondary","measure":"Immunogenicity Endpoints","time_frame":"At week 28, 4 weeks after the second vaccination","description":"Seroconversion rate of anti-Vi IgG by Geometric Mean Titers (GMT) will be measured 4 weeks after the second vaccination using an in-house ELISA assay using standardized reagents and reference serum. The level of the specific anti-Vi IgG in ELISA units for each serum sample is determined by comparison to a reference serum. The number of anti-Vi IgG positive sera will be used to calculate the seroconversion rates."},{"outcome_type":"other","measure":"Exploratory Endpoints","time_frame":"At week 4, 4 week after MMR vaccination","description":"Seroconversion rates of Measles, Mumps and Rubella will be determined 4 week after MMR vaccination. Serum titers will be measured by routinely used commercially available ELISA kits. Kit-specific threshold of positivity will be used to determine specific seroconversion rates."},{"outcome_type":"other","measure":"Exploratory Endpoints","time_frame":"At week 28, 4 weeks after the second vaccination and at week 96 after the booster dose in selected group.","description":"Serum bactericidal titers will be determined using in-house functional assay assessing the number of survived S. Typhi Ty2 strain colony on Luria-Bertani plate. Serum bactericidal titer is defined as the highest dilution of serum that gives 50% of inhibition of colony formation of S. Typhi."}]}
{"nct_id":"NCT03350776","start_date":"2018-04-17","enrollment":960,"brief_title":"Practices and Organizations Related to Emerging Occupations of Care (EPOCK) Coordination in Oncology","official_title":"Pilot Observational and Analytic Study of Practices and Organizations Related to Emerging Occupations of Care Coordination in Oncology: Modeling the Concept of Care Coordination in Oncology (EPOCK)","primary_completion_date":"2019-10-02","study_type":"Observational","rec_status":"Completed","completion_date":"2019-10-30","last_update":"2020-06-19","description":"Several stakeholders are implied in cancer care pathways and there is a need for coordinating their actions. New occupations of care coordination have thus emerged. However, the conditions of their efficiency have been too few reported and included discrepancies between reports. In this context, the main objective is to propose a modeling of care coordination and associated emerging occupations (nurse-based) by comparing theoretical expected outcomes to professionals, patients and caregivers representations.","other_id":"CHUBX 2016/31","observational_model":"Other","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Four samples :\r\n\r\n          -  Professionals of cancer care coordination\r\n\r\n          -  Cancer patients\r\n\r\n          -  Family caregivers of the selected patients\r\n\r\n          -  Professionals working with professionals of care coordination","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  For health institutions: public or private institutions in which nurses contributing\r\n             to care coordination. Each institution will be associated with one type of\r\n             coordination occupation, even if other healthcare workers contribute to care\r\n             coordination in the same institution.\r\n\r\n          -  For professionals of care coordination: nurses contributing to care coordination in\r\n             oncology (IDEC , IDE TAS, IPO, IDE AMA, IDE-CO, IDE HAD-CAD or IDE ETP)\r\n\r\n          -  For professionals working with professionals of care coordination:\r\n\r\n               -  Medical and non-medical healthcare professionals (oncologist, surgeon, nurses),\r\n                  administrative professionals (secretary), professionals of supportive care\r\n                  (psychologists, social workers) and volunteers in patient organizations.\r\n\r\n               -  Private practitioners: general practitioner, private nurses, pharmacist\r\n\r\n          -  For the patients : adults under supervision of the selected professionals of care\r\n             coordination for at least four weeks and able to express themselves\r\n\r\n          -  For the caregivers: family caregivers of the selected patients.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  For health institutions: private healthcare networks, territorial support platforms,\r\n             home-based care providers, healthcare houses\r\n\r\n          -  For professionals of care coordination: coordinating medical doctors of care networks,\r\n             coordinating medical doctors of hospital care at home, practitioners of regional\r\n             cancer networks.\r\n\r\n          -  For the patients: <18 years old\r\n      ","sponsor":"University Hospital, Bordeaux","sponsor_type":"Other","conditions":"Care Coordination in Oncology","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Care coordination","description":"Care coordination and associated emerging occupations by comparing theoretical expected outcomes to professionals, patients and caregivers representations"}],"outcomes":[{"outcome_type":"primary","measure":"Modeling of care coordination in Oncology in France","time_frame":"During the whole period (36 months: from Month 1 to Month 36)","description":"Constitutive elements of modelling of care coordination in oncology in France (qualitative analysis)"},{"outcome_type":"secondary","measure":"Care coordination profesionals quality of life","time_frame":"Quantitative cross sectional survey (from Month 10 to Month 29)","description":"Three scores : perceived organizational support, role conflict and commitment to the organization"},{"outcome_type":"secondary","measure":"Satisfaction with care coordination for profes professionals working with professionals of care coordination","time_frame":"Quantitative cross sectional survey (from Month 10 to Month 29)","description":"Score of satisfaction"},{"outcome_type":"secondary","measure":"Patients quality of life and satisfaction with care coordination","time_frame":"Quantitative cross sectional survey (from Month 10 to Month 29)","description":"Score of satisfaction and score of quality of life (measured with the European Organization for Research and Treatment (EORTC) quality of life questionnaire)"},{"outcome_type":"secondary","measure":"Caregivers burden with care coordination","time_frame":"Quantitative cross sectional survey (from Month 10 to Month 29)","description":"Score of burdean (Zarit Burden Interview) with care coordination"},{"outcome_type":"secondary","measure":"Caregivers satisfaction with care coordination","time_frame":"Quantitative cross sectional survey (from Month 10 to Month 29)","description":"Score of satisfaction with care coordination"}]}
{"nct_id":"NCT03535857","start_date":"2018-04-17","phase":"N/A","enrollment":50,"brief_title":"Effectiveness of Bilateral PTNS Compared to Unilateral PTNS for the Treatment of Overactive Bladder/Urge Incontinence","official_title":"Effectiveness of Bilateral PTNS Compared to Unilateral PTNS for the Treatment of Overactive Bladder/Urge Incontinence","primary_completion_date":"2023-05-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-12-31","last_update":"2021-04-08","description":"This study is designed to evaluate whether bilateral Posterior Tibial Nerve Stimulation is more effective than unilateral Posterior Tibial Nerve Stimulation at treating overactive bladder and urge urinary incontinence","other_id":"STUDY19100230","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":99,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Female patients over the age of 18 who have previously tried and failed, or were\r\n             unable to tolerate, behavioral therapy\r\n\r\n          2. Patients who consent to participate in the study\r\n\r\n          3. Patients on pharmacologic therapy at the time of recruitment can continue their\r\n             treatment\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Pregnant patients\r\n\r\n          2. Patients with pacemakers of implantable defibrillators\r\n\r\n          3. Patients with neurogenic bladder\r\n\r\n          4. Patients who have received Botox or have an implant for sacral nerve stimulation\r\n\r\n          5. Patients with uncontrolled bleeding disorder\r\n\r\n          6. Patients with unhealed ulcers or with leg edema surrounding medial malleolus\r\n      ","sponsor":"Gnankang Sarah Napoe","sponsor_type":"Other","conditions":"Overactive Bladder Syndrome|Urinary Incontinence, Urge","interventions":[{"intervention_type":"Device","name":"Device: PTNS","description":"Use of PTNS on the ankle for 30 minutes"}],"outcomes":[{"outcome_type":"primary","measure":"Change in OAB symptom severity score","time_frame":"12 weeks","description":"Overactive Bladder questionnaire short form symptom severity will be administered at baseline, 4 weeks, 8 weeks then 12 weeks. The questionnaire score ranges from 0 to 100. Those with more bothersome symptoms will have higher scores. The investigators expect more improvement in symptoms from participants receiving bilateral stimulation compared to those with unilateral stimulation."},{"outcome_type":"secondary","measure":"Change in daily number of voids","time_frame":"12 weeks","description":"Number of voids at baseline will be compared to the number of voids after completion of PTNS at 12 weeks"},{"outcome_type":"secondary","measure":"Change in number of incontinence episodes per 24 hours","time_frame":"12 weeks","description":"The number of incontinence episodes will be calculated from the voiding diary"},{"outcome_type":"secondary","measure":"Change in nocturia episodes","time_frame":"12 weeks","description":"A bladder diary will be used to determine how many episodes of voiding occurs at night (nocturia). Baseline nocturia will be compared to nocturia at 12 weeks"},{"outcome_type":"secondary","measure":"Evaluate impact of treatment on quality of life","time_frame":"12 weeks","description":"The incontinence impact questionnaire will be used to measure impact on qualify of life. The questionnaire score range from 0 to 100 with higher scores indicating worse quality of life."}]}
{"nct_id":"NCT03501095","start_date":"2018-04-17","enrollment":480,"brief_title":"Evaluation of Laryngeal Morbidity After Orotracheal Intubation by Vocal Analysis and Laryngostroboscopy","official_title":"Evaluation of Laryngeal Morbidity After Orotracheal Intubation by Vocal Analysis and Laryngostroboscopy: A Pilot Study","primary_completion_date":"2019-03-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2019-03-31","last_update":"2018-06-27","description":"The delicate structures of the larynx can be compromised by innumerable causes, one of these is represented by endotracheal intubation. More frequently, these damages are represented by hematomas, edema and granulomas of the vocal cords. The pathophysiology of laryngeal damage can be explained by an ischemic attack of the chordal mucosa. Numerous risk factors can cause the onset of damage, some depending on the practice itself, such as size and type of endotracheal tube, cuff pressure, use of mandrels and / or inserting devices, use of oral or nasogastric tubes, use of neuromuscular inhibitors or sleep-inducing drugs and the duration of the intervention; others from patient-related factors, such as gender, weight, history of exposure of smoking habit, or a history of gastroesophageal reflux (GERD). The incidence of such symptoms varies from 0% to 18% among the general population, with an average of 6% with resolution of most of the symptoms within 72 hours unless substantial damage has occurred to the vocal cords or to the arytenoids. In general, the incidence of such laryngeal complications has been described by several studies, but there is no standardized protocol for measuring and evaluating their entity. The purpose of this study is to determine how the voice and the chordal clinical aspect vary after oro-tracheal intubation, evaluated through voice analysis and laryngostroboscopy.","other_id":"AOCarita","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":70,"population":"The investigators will study patients undergoing general anesthesia for urological or\r\n        general surgery at the University Hospital (AOU) Maggiore della Carit di Novara in the\r\n        time span between 1st April 2018 to 31st March 2019.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  all patients between the age of 18 and 70 years old who have given informed consent\r\n             and who must undergo general or urological surgery will be included.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  age: below 18 or over 70 years old,\r\n\r\n          -  refusal of the patient to consent,\r\n\r\n          -  risk of the American Society Anesthesiologists (ASA) > III,\r\n\r\n          -  patients previously subjected to demolition surgery of head-neck and/or\r\n             chemo-radiotherapy of the same structures,\r\n\r\n          -  patients with a history of hoarseness, vocal tract abnormalities and / or hearing\r\n             impairment.\r\n      ","sponsor":"Azienda Ospedaliero Universitaria Maggiore della Carita","sponsor_type":"Other","conditions":"Intubation Complication|Vocal Cord Dysfunction|Vocal Tone Disorder|Intubation;Difficult","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Vocal analysis and Laryngostroboscopy","description":"Vocal analysis study the acoustic emission of the pneumo-phono-articulatory system, i.e. the vocal signal. Currently, digital technology instruments enable the processing and analysis of the verbal signal quickly and reliably, also offering graphical products and numerical data. Among the various existing software products for the study of the vocal signal, PRAAT is available. In practice, the vocal parameters are acquired in a non-invasive way with a microphone.\r\nLaryngostroboscopy is one of the most widely used techniques for laryngeal clinical evaluation. This is a non-invasive endoscopic practice performed by means of a flexible fibroscope, which, through a pulsed light source, allows visualization of the chordal movement."}],"outcomes":[{"outcome_type":"primary","measure":"Incidence, expressed as the number of new cases per year, of laryngeal complications arising after endotracheal intubation. This complications will be related to:","time_frame":"Presence of laryngeal damage 24-48 hours after surgery not visible at the pre-surgery visit.","description":"the variation of voice parameters, during acoustic analysis, above 95% percentile, compared to healthy volunteers, of patients who undergo orotracheal intubation.\r\nthe presence or absence of laryngeal damage at laryngostroboscopy."},{"outcome_type":"secondary","measure":"Correlation between weight and modified Mallampati","time_frame":"The data will be assessed during pre-surgery visit","description":"On the x axis will be plotted the weight measured in kilograms, on y axis will be plotted Mallampati scale."},{"outcome_type":"secondary","measure":"Correlation between endotracheal tube size and presence of laryngeal damage","time_frame":"The data will be assessed 24 hours after surgery","description":"the size tube is measured in millimeters while laryngeal damage will be measured by Mendel's scale"},{"outcome_type":"secondary","measure":"Correlation between use or not of mandrel and the modifications of Jitter %","time_frame":"The data will be assessed 24 hours after surgery","description":"The Jitter % will be measured with software PRAAT"},{"outcome_type":"secondary","measure":"Correlation between use or not of mandrel and the modifications of Shimmer %","time_frame":"The data will be assessed 24 hours after surgery","description":"The Shimmer % will be measured with software PRAAT"}]}
{"nct_id":"NCT03490513","start_date":"2018-04-15","phase":"Phase 4","enrollment":120,"brief_title":"Aromatase Inhibitors and Weight Loss in Severely Obese Men With Hypogonadism","official_title":"Aromatase Inhibitors and Weight Loss in Severely Obese Men With Hypogonadism","primary_completion_date":"2023-04-14","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2024-04-14","last_update":"2021-01-14","description":"The investigators have preliminary data suggesting that obese patients with hypogonadotropic hypogonadism (HHG) have minimal benefit from testosterone therapy likely because of its conversion to estradiol by the abundant aromatase enzyme in the adipocytes. The increased conversion of androgens into estrogens in obese men results in a negative feedback of high estradiol levels on hypothalamus and pituitary, inhibiting the production of gonadotropin-releasing hormone (GnRH), luteinizing hormone (LH) and follicle stimulating hormone (FSH) and, as a consequence, of testosterone by the testis. Testosterone administration could increase estradiol production, further promoting the inhibitory feedback to the hypothalamic-pituitary-gonadal axis. Although weight loss from lifestyle modification has been shown to reduce estradiol and increase testosterone levels, the effect is at best modest and weight regain results in recurrence of hypogonadism. The use of aromatase inhibitors, in combination with weight loss, could be an effective alternative strategy due to its action at the pathophysiology of the disease. Intervention Subjects (body mass index of 35, testosterone <300 ng/dl) will be randomized to the active (anastrozole) or control (placebo) group. Anastrozole 1 mg tablet / day will be self-administered with or without food, at around the same time every day (active group); placebo 1 tablet/day with or without food to take at around the same time every day (control group). The study duration will be 12 months. Both groups will undergo lifestyle intervention consisting of diet and supervised exercise program. Target weight loss will be at least 10% of baseline body weight during the intervention. Subjects will attend weekly group behavior modification sessions which will last ~75-90 min for the first 3 months and decreased to every two weeks from 3 to 12 months. Subjects will attend supervised research center-based exercise sessions during the first 6 months followed by community fitness center-based sessions during the next 6 months for at least 2 d/wk, with recording of home-based exercises for the other 2-4 days/week.","other_id":"H-41814","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","intervention_model_description":"Intervention: Subjects will be randomized to 2 groups: 1) placebo+weight loss, and 2) anastrozole+weight loss. Intervention will be conducted for 12 months.\r\nWeight loss + placebo: Subjects will participate in a supervised dietary and exercise program plus a placebo.\r\nAnastrozole + weight loss: Subjects will participate in a supervised dietary and exercise program plus the aromatase inhibitor, anastrozole at 1 mg daily.\r\nAll subjects will be provided supplements to ensure an intake of ~1500 mg of calcium/day and ~1000 IU vitamin D/day. We will maintain a serum 25-hydroxyvitamin D level of at least 30 ng/dl. Additional vitamin D supplements will be provided for those with level <30 ng/dl.\r\nDosage adjustments and monitoring will be done by an unblinded investigator.","sampling_method":"","gender":"Male","minimum_age":40,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  obese men with body mass index (BMI) of 35 kg/m2\r\n\r\n          -  age between 40 to 65 years old\r\n\r\n          -  average fasting testosterone level from 2 measurements taken between 8 to 10 AM on 2\r\n             separate days of <300 ng/dl\r\n\r\n          -  Luteinizing Hormone (LH) of <9.0 mIU/L\r\n\r\n          -  Estradiol of 17 pg/ml\r\n\r\n          -  Symptoms consistent with androgen deficiency as assessed by Androgen Deficiency in\r\n             Aging Male (ADAM) questionnaire\r\n\r\n        Exclusion criteria:\r\n\r\n          -  pituitary or hypothalamic disease,\r\n\r\n          -  drugs affecting gonadal hormone levels, production and action or bone metabolism\r\n             (bisphosphonates, teriparatide, denosumab, glucocorticoids, phenytoin)\r\n\r\n          -  diseases affecting bone metabolism (e.g. hyperparathyroidism, untreated\r\n             hyperthyroidism, osteomalacia, chronic liver disease, significant renal failure,\r\n             hypercortisolism, malabsorption, immobilization, Paget's disease),\r\n\r\n          -  prostate carcinoma or elevated serum prostate specific antigen (PSA)> 4 ng/ml,\r\n\r\n          -  Hematocrit > 50%,\r\n\r\n          -  untreated severe obstructive sleep apnea,\r\n\r\n          -  Cardiopulmonary disease (e.g. recent myocardial infarction, unstable angina, stroke)\r\n             or unstable disease (e.g., New York Heart Association Class III or IV congestive heart\r\n             failure\r\n\r\n          -  severe pulmonary disease requiring steroid pills or the use of supplemental oxygen\r\n             (that would contraindicate exercise or dietary restriction)\r\n\r\n          -  History of deep vein thrombosis or pulmonary embolism\r\n\r\n          -  severe lower urinary tract or prostate symptoms with International Prostate Symptom\r\n             Score (IPSS) above 19\r\n\r\n          -  excessive alcohol or substance abuse\r\n\r\n          -  unstable weight (i.e. >2 kg) in the last 3 months\r\n\r\n          -  condition that could prevent from completing the study\r\n\r\n          -  screening bone mineral density (BMD) T-score of <-2.0 at the spine, femoral neck or\r\n             total femur\r\n\r\n          -  history of osteoporosis or fragility fracture\r\n\r\n          -  Diabetes mellitus with a fasting blood glucose of >140 mg/dl, and/or Hemoglobin A1C\r\n             (A1C) >8.5%.\r\n      ","sponsor":"Baylor College of Medicine","sponsor_type":"Other","conditions":"Hypogonadism, Hypogonadotropic|Obesity","interventions":[{"intervention_type":"Drug","name":"Drug: anastrozole (1 mg/day)","description":"Participants will take Anastrozole 1mg per day, attend behavioral classes conducted by a dietitian, receive instruction on how to loss 10% of their body weight and participate in a supervised exercise training program."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Participants will take a placebo tablet every day, attend behavioral classes conducted by a dietitian, receive instruction on how to loss 10% of their body weight and participate in a supervised exercise training program."}],"outcomes":[{"outcome_type":"primary","measure":"Hormonal Profile Changes","time_frame":"12 months","description":"Assessed by changes in serum testosterone levels."},{"outcome_type":"primary","measure":"Changes in muscle strength","time_frame":"12 months","description":"Assessed by changes in knee extension strength using a dynamometer."},{"outcome_type":"primary","measure":"Changes in Lean mass","time_frame":"12 months","description":"Assessed by body composition tissue measurement using dual energy x-ray absorptiometry."},{"outcome_type":"primary","measure":"Changes in total hip bone mineral density (BMD)","time_frame":"12 months","description":"Assessed by dual energy absorptiometry."},{"outcome_type":"secondary","measure":"Other gonadal hormone","time_frame":"12 months","description":"Assessed by changes in serum estradiol"},{"outcome_type":"secondary","measure":"Pituitary hormone","time_frame":"12 months","description":"Assessed by changes in serum luteinizing hormone (LH)"},{"outcome_type":"secondary","measure":"Pituitary hormone","time_frame":"12 months","description":"Assessed by changes in serum follicle stimulating hormone (FSH)"},{"outcome_type":"secondary","measure":"Changes in thigh muscle volume","time_frame":"12 months","description":"Assessed magnetic resonance imaging of both thighs."},{"outcome_type":"secondary","measure":"Changes in symptoms of hypogonadism","time_frame":"12 months","description":"Assessed by the Androgen Deficiency in Aging Male (ADAM) questionnaire; higher scores indicating worse outcome"},{"outcome_type":"secondary","measure":"Changes in symptoms of hypogonadism","time_frame":"12 months","description":"Assessed by the International Index of Erectile Function (IIEF) questionnaire; higher scores indicating better outcome"},{"outcome_type":"secondary","measure":"Changes in symptoms of hypogonadism","time_frame":"12 months","description":"Assessed by the 36-Item Short-Form Health Survey (SF-36) questionnaire; scores on the physical and mental component subscales of the SF-36 range from 0 to 100, with higher scores indicating better health status"},{"outcome_type":"secondary","measure":"Changes in visceral adipose tissues","time_frame":"12 months","description":"Assessed by dual energy x-ray absorptiometry"},{"outcome_type":"secondary","measure":"Changes in metabolic risk factors","time_frame":"12 months","description":"Assessed by hemoglobin A1C"},{"outcome_type":"secondary","measure":"Changes in metabolic risk factors","time_frame":"12 months","description":"Assessed by lipid profile"},{"outcome_type":"secondary","measure":"Changes in metabolic risk factors","time_frame":"12 months","description":"Assessed by homeostasis model assessment for insulin resistance (HOMA-IR)"},{"outcome_type":"secondary","measure":"Changes in volumetric bone density","time_frame":"12 months","description":"Assessed by high-resolution peripheral quantitative computer tomography"},{"outcome_type":"secondary","measure":"Changes in bone quality","time_frame":"12 months","description":"Assessed by changes in finite element analysis using high-resolution peripheral quantitative computer tomography"},{"outcome_type":"secondary","measure":"Changes in bone markers","time_frame":"12 months","description":"Assessed by serum C-telopeptide"},{"outcome_type":"secondary","measure":"Changes in bone markers","time_frame":"12 months","description":"Assessed by serum osteocalcin"},{"outcome_type":"secondary","measure":"Changes in bone markers","time_frame":"12 months","description":"Assessed by serum procollagen 1 Intact N-terminal"}]}
{"nct_id":"NCT03311646","start_date":"2018-04-15","phase":"N/A","enrollment":31,"brief_title":"Impact of Exclusive Use of Low Nicotine Cigarettes on Compensatory Smoking","official_title":"Impact of Exclusive Use of Low Nicotine Cigarettes on Compensatory Smoking","primary_completion_date":"2018-11-15","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-12-01","last_update":"2020-01-28","description":"Smoking is the leading cause of preventable death in the United States. An FDA-mandated reduction in the nicotine content of cigarettes might reduce the health burden of tobacco by reducing the prevalence of smoking. The proposed project will test the impact of nicotine reduction on smoking behavior and smoke exposure in a setting where participants are restricted from using their usual brand cigarettes.","other_id":"950","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","intervention_model_description":"All participants experienced an NNC phase (baseline) and a VLNC phase.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  male or female participants who are least 18 years old and smoke daily\r\n\r\n          -  willing to stay in a hotel for two four-night stays during the prearranged dates\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  unwilling to use research cigarettes as part of the trial\r\n\r\n          -  pregnant, trying to become pregnant, or breastfeeding\r\n\r\n          -  additional smoking and health criteria determined at screening\r\n      ","sponsor":"Medical University of South Carolina","sponsor_type":"Other","conditions":"Smoking","interventions":[{"intervention_type":"Other","name":"Other: Normal nicotine content cigarettes (NNC, Baseline)","description":"Participants will exclusively smoke research cigarettes that have a normal nicotine content for five days/four nights while staying in a hotel."},{"intervention_type":"Other","name":"Other: Very low nicotine content (VLNC)","description":"Participants will exclusively smoke research cigarettes that have a very low nicotine content for five days/four nights while staying in a hotel."}],"outcomes":[{"outcome_type":"primary","measure":"Breath Sample (Expired Carbon Monoxide)","time_frame":"8am, 12pm, 4pm, 8pm beginning with 4pm on Day 1 and ending with 12pm on Day 5","description":"Measure of short term smoke exposure, higher scores indicate more smoke exposure. While in the hotel, participants provided breath samples at 8am, 12pm, 4pm, 8pm beginning with 4pm on Day 1 and ending with 12pm on Day 5. Outcome here are from the VLNC condition. Baseline (NNC) data are reported in the baseline characteristics section."},{"outcome_type":"primary","measure":"Average Cigarettes Smoked Per Day","time_frame":"Participants returned smoked cigarette butts each day at 12pm, creating four 24-hr samples for each hotel phase. Data reported here are for the four 24-hr samples of the VLNC condition.","description":"Measure of smoking behavior. Participants returned smoked cigarette butts each day at 12pm, creating four 24-hr samples for each hotel phase (NNC and VLNC). Outcomes reported here are from the VLNC condition. Baseline (NNC) data are reported in the baseline characteristics section."},{"outcome_type":"secondary","measure":"Minnesota Nicotine Withdrawal Scale","time_frame":"Participants complete this self-report questionnaire on Days 2-5 during the NNC (Baseline) and VLNC conditions. Presented here are the scores from the VLNC condition.","description":"Measure of withdrawal, Total Score is presented here, Range from 0-60 with higher scores indicating greater withdrawal. Participants complete this self-report questionnaire on Days 2-5 during the NNC (Baseline) and VLNC conditions. Presented here are the scores from the VLNC condition. Data from the NNC (Baseline) conditions are reported in the baseline section."},{"outcome_type":"secondary","measure":"Questionnaire of Smoking Urges","time_frame":"Participants complete the Questionnaire of Smoking Urges on Days 2-5 of both the NNC (baseline) and VLNC Condition. Data here are from the VLNC Condition.","description":"Measure of craving, Range from 10-70, Higher scores indicate greater craving. Participants complete the Questionnaire of Smoking Urges on Days 2-5 of both the NNC (baseline) and VLNC Condition. Data here are from the VLNC Condition."}]}
{"nct_id":"NCT04207515","start_date":"2018-04-15","phase":"N/A","enrollment":20,"brief_title":"The Effect of Conscious Sedation on Acute Stress","official_title":"The Effect of Conscious Sedation on Salivary Alpha-Amylase Levels in the Patients Undergoing Impacted Third Molar Surgery","primary_completion_date":"2019-06-15","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-09-20","last_update":"2019-12-23","description":"The specific aims of the present study were to evaluate sAA responses to impacted third molar extractions at different time points in the patients under conscious sedation with local anesthesia and to examine the relationship between sAA, conscious sedation and dental anxiety. The null hypothesis was that conscious sedation could be considered to reduce salivary alpha amylase level during the wisdom tooth surgery.","other_id":"2018/24","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"Male","minimum_age":19,"maximum_age":33,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Man\r\n\r\n          -  18-35 years\r\n\r\n          -  individuals without chemotherapy or radiotherapy history\r\n\r\n          -  individuals without antibiotics and NSAIDs history in the last month\r\n\r\n          -  individuals without any medications that affect saliva content in the last 1 month\r\n\r\n          -  individuals without corticosteroid treatment history\r\n\r\n          -  nonsmokers\r\n\r\n          -  wisdom tooth which is indicated to extract\r\n\r\n          -  individuals without acute infectious lesion in the mouth\r\n\r\n          -  individuals without alcohol or substance abuse\r\n\r\n          -  individuals without inflammatory bone disease\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Woman\r\n\r\n          -  individuals with any systemic disorders\r\n\r\n          -  individuals with chemotherapy and radiotherapy history\r\n\r\n          -  individuals with antibiotics and NSAIDs history in the last month\r\n\r\n          -  individuals with use of antibiotics and NSAIDs history in the last month\r\n\r\n          -  individuals with corticosteroid treatment history\r\n\r\n          -  Smokers\r\n\r\n          -  individuals with acute infectious lesion in the mouth\r\n\r\n          -  individuals with inflammatory bone disease\r\n\r\n          -  individuals with alcohol or substance abuse\r\n      ","sponsor":"University of Beykent","sponsor_type":"Other","conditions":"Dental Anxiety|Dental Fear|Tooth Extraction Status Nos","interventions":[{"intervention_type":"Procedure","name":"Procedure: Procedures of wisdom tooth removal surgery under conscious sedation","description":"The first specimen of saliva was taken at the first time patient came to clinic (t1). Saliva was allowed to flow in the floor of mouth an 1 ml was then collected using a Pasteur pipette. First day after examination, patient was given an appointment. The second time of the saliva was taken was when the patient sat in the chair for extraction (t2). The other times of saliva samples were taken were before local anesthesia (t3), immediately after extraction (t4) and at 4 h after extraction (t5). Due to the localization and position of the third molar, osteotomy was performed using a 20,000-rpm hand piece under irrigation for all patients. Some cases required tooth sectioning. 3-0 silk suture was used at the end of the surgery."},{"intervention_type":"Procedure","name":"Procedure: Procedures of wisdom tooth removal surgery under local anesthesia","description":"The first specimen of saliva was taken at the first time patient came to clinic (t1). Saliva was allowed to flow in the floor of mouth an 1 ml was then collected using a Pasteur pipette. First day after examination, patient was given an appointment. The second time of the saliva was taken was when the patient sat in the chair for extraction (t2). The other times of saliva samples were taken were before local anesthesia (t3), immediately after extraction (t4) and at 4 h after extraction (t5). Due to the localization and position of the third molar, osteotomy was performed using a 20,000-rpm hand piece under irrigation for all patients. Some cases required tooth sectioning. 3-0 silk suture was used at the end of the surgery."}],"outcomes":[{"outcome_type":"primary","measure":"Salivary Alpha Amylase Level","time_frame":"Change from baseline salivary alpha-amylase levels at different time points in one day","description":"The measurement of salivary alpha amylase levels (t1. The first time the patient came to clinic, t2. When the patient sat in the chair for extraction, t3. Before local anesthesia, t4. Immediately after extraction, t5. 4 h after extraction)"},{"outcome_type":"secondary","measure":"Systolic blood pressure (SBP) level","time_frame":"Change from baseline systolic blood pressure levels at different time points in one day","description":"The measurement of Systolic blood pressure level at different time points (preoperative time; intraoperative time-after local anesthesia, intraoperative time-after extraction, postoperative time)"},{"outcome_type":"secondary","measure":"Diastolic blood pressure (DBP) level,","time_frame":"Change from baseline diastolic blood pressure levels at different time points in one day","description":"Diastolic blood pressure level at different time points (preoperative time; intraoperative time-after local anesthesia, intraoperative time-after extraction, postoperative time)"},{"outcome_type":"secondary","measure":"Oxygen saturation (SO2) level","time_frame":"Change from baseline oxygen saturation levels at different time points in one day","description":"Oxygen saturation (SO2) level at different time points (preoperative time; intraoperative time-after local anesthesia, intraoperative time-after extraction, postoperative time)"},{"outcome_type":"secondary","measure":"Heart rate (HR) level","time_frame":"Change from baseline heart rate levels at different time points in one day","description":"Heart rate (HT) level at different time points (preoperative time; intraoperative time-after local anesthesia, intraoperative time-after extraction, postoperative time)"}]}
{"nct_id":"NCT03570463","start_date":"2018-04-11","enrollment":1500,"brief_title":"GLA:D Back: Patient Education and Exercises for Self-management of Back Pain","official_title":"GLA:D Back: Implementation of Group-based Patient Education and Exercises to Support Self-management of Back Pain","primary_completion_date":"2022-12-31","study_type":"Observational [Patient Registry]","rec_status":"Recruiting","completion_date":"2022-12-31","last_update":"2021-06-01","description":"The GLA:D Back project evaluates the implementation of standardised patient education and exercise therapy for people with persistent or recurrent low back pain (LBP) in a hybrid implementation-effectiveness design. This involves evaluating the process of implementation as well as clinician level outcomes and patient level outcomes. GLA:D (Good Life with OsteoArthritis in Denmark) is a non-profit initiative and registered trademark from the University of Southern Denmark. It educates clinicians in delivering evidence-based care for musculoskeletal health conditions and registers outcomes in a clinical registry. GLA:D Back uses only the acronym. The main activity of the implementation strategy is a two-days course for physiotherapists and chiropractors in delivering patient education and exercise therapy that is aimed at supporting patient self-management of LBP. This comes with ready-to-use patient education materials and exercise programs. The course is targeted at chiropractors and physiotherapists, but any health care provider authorised to treat patients with back pain in Denmark can participate, i.e. medical doctors, physiotherapists and chiropractors. The clinical intervention is a group-based program consisting of two sessions of patient education and 8 weeks of supervised exercises. The program uses a cognitive-behavioural approach and the aim of the exercise component is to restore the patient's ability and confidence to move freely. Clinicians decide which patients are offered the program. The implementation process is evaluated in a dynamic process monitoring the penetration, adoption and fidelity of the clinical intervention. The education of clinicians is evaluated via clinician-level outcomes concerning attitudes towards back pain and confidence in managing people with LBP. The clinical intervention and potential effect mechanisms are evaluated at the patient-level in an observational design. Patients who are participating in the GLA:D Back program are followed using measures of knowledge, skills, beliefs, performance, self-efficacy and success in self-management. Effects at a national level will be investigated via data from national registries of health care utilisation and sick-leave. Patient- and clinician reported data are collected in a registry.","other_id":"DPA 2015-57-0008 SDU 17/30591","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Participants are people consulting a physiotherapist or chiropractor who are trained in the\r\n        GLA:D Back program. The decision to enrol a patient in GLA:D Back is at the discretion of\r\n        the clinician in a dialogue with the patient, when clinicians judge that the patient would\r\n        benefit from improved self-management skills","criteria":"\n        Inclusion Criteria:\r\n\r\n        The decision to invite a patient to participate in the GLA:D Back program is at the\r\n        discretion of the clinician. Clinicians are taught that the program was developed for\r\n        people with persistent or recurrent low back pain and a need for improved self-management\r\n\r\n        Exclusion Criteria:\r\n\r\n        Back pain related to specific spinal or systemic pathology, signs of acute nerve root\r\n        involvement\r\n      ","sponsor":"University of Southern Denmark","sponsor_type":"Other","conditions":"Back Pain, Low","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: GLA:D Back","description":"The intervention aims at improving the participant's ability to self-manage low back pain (LBP). The content is based on a cognitive behavioural approach aimed at supporting pain self-efficacy. An individual session at the beginning and the end of the group sessions involve goal-setting and physical tests. Key messages of the patient education include that pain is not a sign of danger and back pain is explained using a behavioural model of (im)balance between demands and capacity rather than emphasising tissue damage. The exercises aim at restoring natural variation in movement and provides guidance for patients in exploring movement rather than teaching exercises in only one correct manner."}],"outcomes":[{"outcome_type":"primary","measure":"Health care visits primary care","time_frame":"During 12 months after participation","description":"Number of primary care visits from national registries"},{"outcome_type":"other","measure":"Patient compliance","time_frame":"3 months","description":"Proportion of patients enrolled in GLA:D Back that complete the program"},{"outcome_type":"primary","measure":"Quality of Life (Social functioning)","time_frame":"Change from baseline to 12 months","description":"The 36-Item Short Form Health Survey (SF-36) subdomain social functioning, transformed score 0-100"},{"outcome_type":"primary","measure":"Quality of Life (Mental functioning)","time_frame":"Change from baseline to 12 months","description":"The 36-Item Short Form Health Survey (SF-36) subdomain mental functioning, transformed score 0-100"},{"outcome_type":"primary","measure":"General Health","time_frame":"Change from baseline to 12 months","description":"Health thermometer from Eq-5D, score 0= worst imaginable to 100= best imaginable"},{"outcome_type":"primary","measure":"Brief Illness Perceptions Questionnaire (B-IPQ)","time_frame":"Change from baseline to 3 months","description":"Nine items covering the constructs of consequences, timeline (expectations of prognosis), personal control, treatment control, identity (extent of symptoms), coherence (understanding of symptoms), emotional representation, concerns, and cause. Each of the items 1 to 8 are scored 0 - 10. If internal consistency allows so a sum score is calculated (0-80). Cause is registered as text."},{"outcome_type":"primary","measure":"Fear Avoidance Beliefs Questionnaire (FABQ)","time_frame":"Change from baseline to 3 months","description":"FABQ physical activity subscale (0 = no fear avoidance beliefs; 24 = highest possible fear avoidance)"},{"outcome_type":"primary","measure":"The Arthritis Self-efficacy (ASES)","time_frame":"Change from baseline to 6 months","description":"ASES subscales of pain and other symptoms. Each item is scored on a 0 - 10 scale (0 = very uncertain; 10 = very certain)"},{"outcome_type":"primary","measure":"Quality of Life (General health)","time_frame":"Proportions in response categories baseline to 12 months","description":"The 36-Item Short Form Health Survey (SF-36 item1); 5-point likert scale"},{"outcome_type":"primary","measure":"Health care visits hospital","time_frame":"During 12 months after participation","description":"Number of hospital visits due to LBP from national registries"},{"outcome_type":"primary","measure":"Imaging","time_frame":"During 12 months after participation","description":"x-rays, MRI and CT-scans of lower back from national registries"},{"outcome_type":"primary","measure":"Pain medication","time_frame":"During 12 months after participation","description":"Prescriptions of pain medication from national registries"},{"outcome_type":"secondary","measure":"Confidence with exercises","time_frame":"Change from baseline to 3 months","description":"How confident are you in performing exercises in a beneficial way?' (0-10 scale from 'not confident at all' to 'absolutely confident')"},{"outcome_type":"secondary","measure":"Self-assessed physical capacity","time_frame":"Change from baseline to 3 months","description":"Self-assessed physical fitness visual analogue scales on perceived strength, endurance, flexibility, balance, and moving unhindered as compared with that of other people of the same age and sex. Each item is scored on a 9-point scale (1 = poor; 5 = average; 9 = super). Each item is treated as one subscale"},{"outcome_type":"secondary","measure":"Satisfaction with care","time_frame":"3 months","description":"Overall satisfaction with care (5-point Likert scale; 0 = Not at all satisfied, 5 = Extremely satisfied)"},{"outcome_type":"secondary","measure":"Patient reported harms or side effects","time_frame":"3 months","description":"Text description of any side effects or problems experienced in relation to the participation in GLA:D Back."},{"outcome_type":"secondary","measure":"Oswestry Disability Index","time_frame":"Change from baseline to 3, 6, 12 months","description":"Ten items, sum score 0 - 50 recalculated to 0-100 (0 = No disability; 100 = Maximum disability)"},{"outcome_type":"secondary","measure":"Pain Intensity","time_frame":"Change from baseline to 3, 6, 12 months","description":"Numeric Rating Scale 0-10 for typical back pain last week (0 = no pain; 10 = worst imaginable pain)"},{"outcome_type":"secondary","measure":"Work ability","time_frame":"During 12 months after participation","description":"Number of days off work after 1 month of absenteeism available from the 'DREAM' registry from the Danish Ministry of Employment"},{"outcome_type":"secondary","measure":"Brief Illness Perceptions Questionnaire (B-IPQ)","time_frame":"Change from baseline to 6, 12 months","description":"Nine items covering the constructs of consequences, timeline (expectations of prognosis), personal control, treatment control, identity (extent of symptoms), coherence (understanding of symptoms), emotional representation, concerns, and cause. Each of the items 1 to 8 are scored 0 - 10. If internal consistency allows so a sum score is calculated (0-80). Cause is registered as text."},{"outcome_type":"secondary","measure":"Fear Avoidance Beliefs Questionnaire (FABQ)","time_frame":"Change from baseline to 6, 12 months","description":"FABQ physical activity subscale (0 = no fear avoidance beliefs; 24 = highest possible fear avoidance)"},{"outcome_type":"secondary","measure":"The Arthritis Self-efficacy (ASES)","time_frame":"Change from baseline to 3, 12 months","description":"ASES subscales of pain and other symptoms. Each item is scored on a 0 - 10 scale (0 = very uncertain; 10 = very certain)"},{"outcome_type":"secondary","measure":"Quality of Life (General Health)","time_frame":"Proportions in response categories baseline to 3, 6 months","description":"The 36-Item Short Form Health Survey (SF-36 item 1),5-point Likert scale"},{"outcome_type":"secondary","measure":"Quality of Life (Social functioning)","time_frame":"Change from baseline to 3, 6 months","description":"The 36-Item Short Form Health Survey (SF-36) subdomains social functioning, transformed score 0-100"},{"outcome_type":"secondary","measure":"Quality of Life /Mental functioning)","time_frame":"Change from baseline to 3, 6 months","description":"The 36-Item Short Form Health Survey (SF-36) subdomains of mental functioning, transformed score 0-100"},{"outcome_type":"other","measure":"The Pain Attitudes and Beliefs Scale for Physiotherapists (PABS-PT)","time_frame":"Change from before course participation to 4 months","description":"Clinician reported 19-item scale. Two subscales: biomedical orientation and behavioural orientation are scored"},{"outcome_type":"other","measure":"Practitioner Confidence Scale (PCS)","time_frame":"Change from before course participation to 4 months","description":"Clinician reported 4-item scale plus two items added to capture confidence about using a behavioral pain model"},{"outcome_type":"other","measure":"The Determinants of Implementation Behavior Questionnaire (DIBQ)","time_frame":"Immediately after curse participation and 4 months","description":"Clinician level measure of the implementation process. Thirty-one items from the domains of knowledge, skills, beliefs about capability, beliefs about consequences, innovation, patients, intentions, organisation, social influences, social context, behavioural regulation, and innovation strategy"},{"outcome_type":"other","measure":"Adoption","time_frame":"Within 6 months","description":"Proportion of clinicians participating in a GLA:D Back course that delivers the program"},{"outcome_type":"other","measure":"Patients participation","time_frame":"4 months","description":"Clinician reported proportion of invited patients who decide to participate"}]}
{"nct_id":"NCT03450733","start_date":"2018-04-11","enrollment":255,"brief_title":"Wright Medical Technology Metal-on-Metal 522 Post-Market Surveillance Study","official_title":"Post-Market Surveillance of the Wright Medical Technology Metal-on-Metal Total Hip System (FDA 522 Order)","primary_completion_date":"2021-12-01","study_type":"Observational","rec_status":"Enrolling by invitation","completion_date":"2022-09-01","last_update":"2021-06-02","description":"This study is in response to the Food and Drug Administration (FDA) call to all manufacturers with 510(k) clearance for metal-on-metal (MoM) total hip arthroplasty (THA) devices to conduct postmarket surveillance studies. MicroPort has various acetabular shells, acetabular liners, fixation screws, femoral heads, femoral stems, modular necks, and proximal bodies currently cleared for MoM indications. Together these components comprise the Wright Medical Technology (WMT) MoM THA System. The primary objective of the study is to determine the incidence of adverse local tissue reactions (ALTR) in each THA implanted with the WMT MoM THA System overall and to create cross-sectional epochs of  8 years and > 8 years, since implantation.","other_id":"11LJH001","observational_model":"Cohort","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":21,"population":"Group 1: Subjects previously implanted with components of the Wright Medical Technology\r\n        (WMT) Metal-on-Metal (MoM) Total Hip Arthroplasty (THA) System\r\n\r\n        Group 2: Control, non-implanted subjects","criteria":"\n        Inclusion Criteria:\r\n\r\n        To be included in Group 1, subjects must meet all of the following criteria:\r\n\r\n          1. Has been implanted with appropriate components of the WMT MOM THA System\r\n\r\n          2. Has previously undergone primary THA for any of the following:\r\n\r\n               1. non-inflammatory degenerative joint disease including osteoarthritis, traumatic\r\n                  arthritis, or avascular necrosis;\r\n\r\n               2. inflammatory degenerative joint disease including rheumatoid arthritis;\r\n\r\n               3. correction of functional deformity.\r\n\r\n          3. Is willing and able to complete required study visit(s) and assessments\r\n\r\n          4. Plans to be available for the required study visit\r\n\r\n          5. Is capable of providing sufficient blood for sampling according to blood draw\r\n             procedures\r\n\r\n          6. Is willing to sign the approved Informed Consent document\r\n\r\n        Previously implanted bilateral subjects can have both THAs enrolled in the study provided:\r\n        1) the specified combination of components were implanted in both, 2) all other aspects of\r\n        the Inclusion/Exclusion Criteria are satisfied, 3) enrollment does not exceed the subject\r\n        count specified in the Clinical Trial Agreement and protocol enrollment strategy, and 4)\r\n        the subject agrees to a second Informed Consent document and data collection specific to\r\n        the second THA. Enrollment and treatment of a previously unimplanted hip is not permitted\r\n        in this study.\r\n\r\n        To be included in Group 2, subjects must meet all of the following criteria:\r\n\r\n          1. Does not have a metal implant (total hip, total knee, spinal, etc.) with the exception\r\n             of dental implants\r\n\r\n          2. Is not an employee of the Investigator\r\n\r\n          3. Is willing and able to provide Informed Consent document\r\n\r\n          4. Is willing and able to attend the requested study visit(s) and assessments\r\n\r\n          5. Is capable of providing sufficient blood for sampling according to blood draw\r\n             procedures\r\n\r\n        Exclusion Criteria:\r\n\r\n        Subjects will be excluded from either study group if they meet any of the following\r\n        criteria:\r\n\r\n          1. Subject is currently enrolled in another clinical investigation which could affect the\r\n             endpoints of this protocol\r\n\r\n          2. Subject is unwilling or unable to sign the Informed Consent document\r\n\r\n          3. Subject has documented substance abuse issues\r\n\r\n          4. Subject has an emotional or neurological condition that would pre-empt their ability\r\n             or willingness to participate in the study\r\n\r\n          5. Subject is currently incarcerated or has impending incarceration\r\n\r\n          6. Group 1 only: Subject has a condition or previously implanted medical device that\r\n             contraindicates MRI (e.g. pacemaker, implantable defibrillator)\r\n\r\n          7. Group 1 only: Subject was skeletally immature (less than 21 years of age) at time of\r\n             implantation\r\n      ","sponsor":"MicroPort Orthopedics Inc.","sponsor_type":"Industry","conditions":"Osteoarthritis, Hip|Hip Disease|Hip Osteoarthritis|Joint Pain","interventions":[{"intervention_type":"Device","name":"Device: Wright Medical Technology Metal-on-Metal Total Hip System","description":"Subjects in Group 1 previously implanted prior to the study start date will be identified from Investigator records. Collected data will be evaluated in aggregate and cross-sectioned by year of implantation. Subjects will be cross-sectioned by the time that has elapsed between implantation and the initial visit (e.g. 5 years, 6 years) using contiguous visit windows (number of years + 6 months). Subject data will be grouped in order to create cross-sectional epochs of  8 years and > 8 years."}],"outcomes":[{"outcome_type":"primary","measure":"Rate of Adverse Local Tissue Reactions (ALTR)","time_frame":"≤ 8 years and > 8 years, since implantation","description":"To determine the incidence rate of ALTR in subjects implanted with WMT MoM THA System (Group 1)"},{"outcome_type":"secondary","measure":"Determine chromium and cobalt whole blood and serum ion levels across time intervals","time_frame":"≤ 8 years and > 8 years, since implantation","description":"Cobalt and chromium metal ion levels will be measured in whole blood and serum from subjects implanted with the WMT MoM THA System (Group 1) at each defined cross-section interval."},{"outcome_type":"secondary","measure":"Establish baseline for chromium and cobalt whole blood and serum ion levels across time intervals","time_frame":"≤ 8 years and > 8 years, since implantation","description":"Analyze difference in chromium and cobalt whole blood and serum ion levels in subjects implanted with the WMT MoM THA System (Group 1) versus control subjects (Group 2) cross-sectionally."},{"outcome_type":"secondary","measure":"Compare functional outcomes of subjects implanted with the WMT MoM THA System with and without ALTR (Group-1 subjects).","time_frame":"≤ 8 years and > 8 years, since implantation","description":"Calculate and compare composite hip outcomes scores, via the validated HOOS scores, in Group 1 subjects with ALTR versus Group 1 subjects without ALTR"},{"outcome_type":"secondary","measure":"Compare cobalt and chromium metal ion levels in subjects implanted with the WMT MoM THA System with and without ALTR (Group-1 subjects).","time_frame":"≤ 8 years and > 8 years, since implantation","description":"Analyze difference in cobalt and chromium metal ion levels from Group 1 subjects with ALTR versus Group 1 subjects without ALTR"}]}
{"nct_id":"NCT03244722","start_date":"2018-04-10","phase":"N/A","enrollment":352,"brief_title":"Maternal Metabolic and Molecular Changes Induced by Preconception Weight Loss and Their Effects on Birth Outcomes","official_title":"Maternal Metabolic and Molecular Changes Induced by Preconception Weight Loss and Their Effects on Birth Outcomes","primary_completion_date":"2025-08-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2025-08-31","last_update":"2020-12-22","description":"Our hypothesis is that aggressive preconception weight loss in obese women will improve the metabolic health of the mother and the intrauterine environment. An optimized developmental environment will normalize fetal growth and improve clinical fetal and infant outcomes, and theoretically reduce future susceptibility to obesity and cardiometabolic disease.","other_id":"HUM00124673","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  BMI > 30  45 for obese participants OR\r\n\r\n          -  BMI  25 for healthy body weight participants\r\n\r\n          -  No known infertility\r\n\r\n          -  No known risk factors for tubal disease\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Significant medical co-morbidities (e.g. heart, kidney, liver, autoimmune disease)\r\n\r\n          -  Significant anemia\r\n\r\n          -  Cancer other than minor skin cancers\r\n\r\n          -  Conditions that would complicate pregnancy\r\n\r\n          -  Recent use of anti-obesity drugs or appetite suppressants\r\n\r\n          -  Previous bariatric surgery\r\n\r\n          -  Endometriosis AFS (American Fertility Society classification class III or IV)\r\n\r\n          -  Progesterone > 10 IU/ml\r\n\r\n          -  Current pregnancy\r\n\r\n          -  Use of sperm donor\r\n      ","sponsor":"University of Michigan","sponsor_type":"Other","conditions":"Obesity; Familial|Pregnancy Related","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Very-low energy Diet (VLED)","description":"Structured, intensive dietary intervention using liquid meal replacements aimed at providing 800 kcal/day with a weight loss goal of 15% from baseline"},{"intervention_type":"Other","name":"Other: Standard of care (SOC)","description":"Standard consultation with registered dietitian to determine appropriate caloric deficit for a low calorie diet, education and advice to achieve weight loss in obese women. Standard of care for normal weight women"}],"outcomes":[{"outcome_type":"primary","measure":"Preconception weight loss","time_frame":"Baseline to post dietary intervention (16 weeks)","description":"Primary pre-specified outcome is BMI change (kg/m2) after dietary intervention. Trained staff will measure height and weight to the nearest .1cm and .1kg using a wall-mounted, precision stadiometer and calibrated digital scale. BMI will be calculated (kg/m2)."},{"outcome_type":"primary","measure":"Metabolome and inflammatory markers","time_frame":"Delivery","description":"Multivariate computational models will assess the association of maternal and neonate metabolite and inflammatory markers to fetal growth and newborn weight (g) and adiposity (g)."},{"outcome_type":"primary","measure":"Offspring body fat mass","time_frame":"Delivery","description":"Percentage body fat (adiposity) in the offspring of women randomized to Very Low Energy Diet (VLED) compared to those randomized to Standard of Care (SOC). Body composition will be assessed by PeaPod (fat mass in grams)."},{"outcome_type":"primary","measure":"Cord blood related to neonate outcomes","time_frame":"Before and after dietary intervention (16 weeks), delivery","description":"The maternal metabolome (~metabolites) will be related to neonate adiposity, gestational weight gain, pregnancy complications, and intrauterine fetal growth rate."},{"outcome_type":"primary","measure":"DNA methylation","time_frame":"Delivery","description":"Differences in site-specific DNA methylation (~450,000 sites) in offspring cord blood mononuclear cells between the Standard of Care (SOC), Very Low Energy Diet (VLED) and lean groups will be assessed."},{"outcome_type":"secondary","measure":"Participant waist circumference in centimeters","time_frame":"Baseline and post dietary intervention (16 weeks), each trimester of pregnancy (between 8-12 weeks, between 18-22 weeks, and between 28-34 weeks)","description":"The change in waist circumference (cm) will be assessed using a retractable, soft nylon measuring tape."},{"outcome_type":"secondary","measure":"Fetal growth will be assessed by ultrasound","time_frame":"Each trimester of pregnancy (between 8-12 weeks, between 18-22 weeks, and between 28-34 weeks)","description":"Gestational sac dimensions (mm), fundal height (mm), biparietal diameter (mm), head circumference (mm), and waist circumference (mm) will be assessed through ultrasound to determine fetal growth."},{"outcome_type":"secondary","measure":"Infant length and weight","time_frame":"Delivery to 12 month follow-up","description":"Trained staff will measure infant length and weight to the nearest .1cm and .1kg using an infant length board and digital infant scale at delivery, 2-, 4-, 6-, 9-, and 12-months. Ponderal index will be calculated and used to assess change in growth."},{"outcome_type":"secondary","measure":"Metabolite levels","time_frame":"Each trimester of pregnancy (between 8-12 weeks, between 18-22 weeks, and between 28-34 weeks), delivery","description":"Relationships between metabolite levels (~2000 metabolites) in maternal blood at each trimester and cord blood mononuclear cell DNA methylation will be compared"},{"outcome_type":"other","measure":"Mode of delivery","time_frame":"Delivery","description":"Categorical as caesarean or vaginal delivery"},{"outcome_type":"other","measure":"Fetal growth abnormalities","time_frame":"Each trimester of pregnancy (between 8-12 weeks, between 18-22 weeks, and between 28-34 weeks)","description":"Categorical as miscarriage, intrauterine growth restriction (IUGR), fetal demise, fetal anomalies"},{"outcome_type":"other","measure":"Maternal diagnosis","time_frame":"Each trimester of pregnancy (between 8-12 weeks, between 18-22 weeks, and between 28-34 weeks), delivery","description":"Categorical as maternal cardiac dysfunction, maternal proteinuria, maternal sleep apnea, fatty liver disease, gestational diabetes, preeclampsia, indicated preterm birth date, failed trial of labor, endometritis, venous thrombosis, COVD-19, surgical wound complications, postpartum anemia, postpartum depression, early termination of breastfeeding."}]}
{"nct_id":"NCT03457090","start_date":"2018-04-05","phase":"N/A","enrollment":30,"brief_title":"Extracorporeal Membrane Oxygenation Evaluated by Transcranial Doppler.","official_title":"Extracorporeal Membrane Oxygenation and Cerebral Blood Flow Velocity Evaluated by Transcranial Doppler","primary_completion_date":"2020-09-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2020-09-30","last_update":"2018-04-18","description":"To determine how venoarterial extracorporeal membrane oxygenation (ECMO) affects cerebral blood flow velocity (CBFV) measured by transcranial doppler (TCD), to determine whether specific changes in cerebral blood flow velocity may be associated with neurologic injury and to determine modifications of CBFV after withdrawal of ECMO.","other_id":"RC31/18/0042","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","intervention_model_description":"Patient treated with Venoarterial Extracorporeal membrane oxygenation (ECMO) Realization of transcranial doppler (TCD) of the right and left middle cerebral artery in the first 48 hours of the setting up of the ECMO with joint realization of an Trans-thoracic echocardiography (TTE) then every 24 hours until the end of the using of the ECMO and the realization of TCD and TTE during the 24 hours after removal of the ECMO.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  adult patient who receiving ECMO therapy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  cervico-encephalic vasculopathy\r\n\r\n          -  lacked an acoustic window allowing for adequate TCD examination\r\n\r\n          -  stroke in medical past.\r\n      ","sponsor":"University Hospital, Toulouse","sponsor_type":"Other","conditions":"Extracorporeal Membrane Oxygenation Complication","interventions":[{"intervention_type":"Other","name":"Other: Examination : a TCD and Trans-Thoracic Echocardiography","description":"Examination that involves the completion of a TCD and an TTE (Trans-Thoracic Echocardiography) :\r\nTo reports clinical parameters at the time of the examination : ECG data: sinus rhythm, atrial or ventricular arrhythmia, state of consciousness, heart rate, O2 saturation\r\nTo review of pharmacological parameters at the time of the examination : presence of sedation; presence, type and dose of catecholamines.\r\nTo collect biological data from the day of the examination : Partial Pressure of O2, PaCO2 (partial pressure) and hematocrit\r\nTo collect possible additional examinations : brain scan, EEG. These are non-invasive exams that do not require patient displacement. Only the samples taken by the medical team as part of the treatment will be analyzed."}],"outcomes":[{"outcome_type":"primary","measure":"Cerebral blood flow velocities evolution","time_frame":"24 hours","description":"Cerebral blood flow velocities evolution over the time"},{"outcome_type":"primary","measure":"The correlation of Cerebral blood flow velocities with the variation of the cardiac output and ECMO flow.","time_frame":"24 hours","description":"The correlation with the variation of the cardiac output and ECMO flow."},{"outcome_type":"secondary","measure":"Relation between acute neurologic injury and variation of CBFV","time_frame":"24 hours","description":"Relation between acute neurologic injury and variation of CBFV detected by TCD."},{"outcome_type":"secondary","measure":"Modification of the CBFV detected by TCD after the withdrawal of the ECMO.","time_frame":"24 hours","description":"Modification of the cerebral blood flow velocity (CBFV) detected by TCD after the withdrawal of the ECMO."},{"outcome_type":"secondary","measure":"Relation between the CBFV, the NIRS, the cardiac flow and the ECMO flow.","time_frame":"24 hours","description":"Relation between the CBFV (cerebral blood flow velocity), the Near Infrared Spectroscopy (NIRS), the cardiac flow and the ECMO flow."}]}
{"nct_id":"NCT03646526","start_date":"2018-04-04","phase":"Phase 1","enrollment":60,"brief_title":"Bioavailability Study of Amitriptyline Hydrochloride Tablets","official_title":"Bioavailability Study of Amitriptyline Hydrochloride Tablets","primary_completion_date":"2019-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-01-31","last_update":"2019-08-01","description":"Main Objectives: In Chinese healthy subjects under both fasting and postprandial conditions, amitriptyline hydrochloride tablets (size: 25 mg) produced by Sandoz Inc., US Orange Book, were used as reference preparations. A single-dose oral reference preparation and amitriptyline hydrochloride tablets (size: 25 mg) produced by Hunan Dongting Pharmaceutical Co., Ltd., and the calculation of the drug by the time course of amitriptyline and its active metabolite, nortriptyline, in vivo The kinetic parameters were compared, and the relative bioavailability of the two was compared to evaluate bioequivalence, which provided the basis for the bioequivalence study of amitriptyline hydrochloride tablets by Hunan Dongting Pharmaceutical Co., Ltd. Secondary Objective: To monitor the safety of fasting and postprandial oral test and reference preparations.","other_id":"ZYYY-AMTL-BE-2018-02","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age 18-45 years old (including 18 and 45 years old), both male and female;\r\n\r\n          2. Male subjects weigh more than 50kg (including 50kg) and female subjects weigh more\r\n             than 45kg (including 45kg); Body mass index [BMI = body weight (kg)/height (m)2] is in\r\n             the range of 19 to 26 kg/m2;\r\n\r\n          3. According to past medical history, comprehensive physical examination and prescribed\r\n             laboratory tests, the investigator determined that Healthy subjects;\r\n\r\n          4. Women of childbearing age have a negative blood pregnancy test and are effective from\r\n             14 days before dosing to 6 months after the end of study Appropriate contraceptive\r\n             measures;\r\n\r\n          5. Male volunteers must take effective and appropriate 14 days before dosing until 6\r\n             months after the end of the study.\r\n\r\n             The contraceptive measures and agrees not to perform sperm donation within six months\r\n             from the administration until the end of the study;\r\n\r\n          6. Fully understand the purpose of the test, the nature of the test, the study\r\n             procedures, and possible adverse reactions.\r\n\r\n             Willing to participate in the trial and sign the informed consent form (the process of\r\n             obtaining the informed consent accords with GCP regulations);\r\n\r\n          7. Communicate well with the researcher, follow the requirements of the entire study, and\r\n             be willing to stay in the Phase I clinical research ward as required.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Can not tolerate venipuncture, who have a history of dizziness and pinching blood;\r\n\r\n          2. Clearly have a history of allergies to the drug ingredients or similar species or to\r\n             two or more other drugs Sensitive history and highly sensitive to food and\r\n             environmental substances;\r\n\r\n          3. Have a history of any serious clinical illness, including but not limited to digestive\r\n             system, cardiovascular system, respiratory system, Urinary system, musculoskeletal\r\n             system, endocrine system, neuropsychiatric system, blood system, immune system\r\n             Patients with a history of diseases and metabolic disorders;\r\n\r\n          4. Laboratory tests (blood routine, urine routine, blood chemistry, etc.) and chest X-ray\r\n             and ECG within 2 weeks before the test Those who have abnormal clinical findings\r\n\r\n          5. Hematological screening (HIV antibody or HBV surface antigen or HCV antibody or TP\r\n             antibody) positive;\r\n\r\n          6. women who are breastfeeding, pregnant or plan to become pregnant recently;\r\n\r\n          7. Female subjects are in lactation or positive pregnancy test during the screening\r\n             period or during the trial;\r\n\r\n          8. Male and female subjects who have not taken effective contraception or whose spouse\r\n             plans to have children within six months;\r\n\r\n          9. Persons with mental or legal disabilities;\r\n\r\n         10. Screening for history of prescription drug abuse and/or history of illegal drug abuse\r\n             within the first 6 months of screening;\r\n\r\n         11. A person who has a history of alcohol abuse within the first 6 months of screening, ie\r\n             drinking more than 14 units of alcohol per week (1 unit = 12 ounces or 360 mL beer,\r\n             1.5 ounces or 45 mL alcohol 40% spirits, 5 ounces or 150mL wine);\r\n\r\n         12. Smoke more than 5 cigarettes per day within 6 months before screening;\r\n\r\n         13. positive for substance abuse screening or alcohol testing;\r\n\r\n         14. Those with a history of hospitalization or surgery within 3 months prior to screening\r\n             (excluding appendicitis);\r\n\r\n         15. Participate in other drug clinical trials within 3 months before screening;\r\n\r\n         16. Have blood donation or acute blood loss history (400 mL) within the first 2 months of\r\n             screening or 1 after the end of the trial Intended to donate blood during the month;\r\n\r\n         17. Those who used any other medicine within 2 weeks before the test (prescription drugs,\r\n             non-prescription drugs, any vitamins) Products or herbs);\r\n\r\n         18. Drink more than 1L of tea, coffee, and/or caffeinated beverages daily;\r\n\r\n         19. Those who have special dietary requirements and cannot accept a unified diet;\r\n\r\n         20. Those who are lactose intolerant (have been drinking milk diarrhea);\r\n\r\n         21. Those who do not understand the content of the informed consent and those who do not\r\n             meet the criteria for the trial enrollment;\r\n\r\n         22. Subjects are poorly adhered to, or the investigator believes there are any individuals\r\n             who are unfit to participate in the trial.\r\n      ","sponsor":"First Affiliated Hospital of Zhejiang University","sponsor_type":"Other","conditions":"Depressive Disorder","interventions":[{"intervention_type":"Drug","name":"Drug: Amitriptyline Hydrochloride 25Mg TabletHunan Dongting","description":"Amitriptyline Hydrochloride 25Mg TabletHunan Dongtingis a generic product manufactured by Hunan Dongting Pharmaceutical Co., Ltd."},{"intervention_type":"Drug","name":"Drug: Amitriptyline Hydrochloride 25Mg TabletSandoz","description":"Amitriptyline Hydrochloride 25Mg TabletSandozis a generic product manufactured by Sandoz Inc;"}],"outcomes":[{"outcome_type":"primary","measure":"Cmax","time_frame":"144 hours post-dose on Day 1,22","description":"Maximum Observed Plasma Concentration for amitriptyline"},{"outcome_type":"primary","measure":"Tmax","time_frame":"144 hours post-dose on Day 1,22","description":"Time to Reach the Maximum Plasma Concentration"},{"outcome_type":"primary","measure":"AUC(0-inf)","time_frame":"144 hours post-dose on Day 1,22","description":"Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for amitriptyline"},{"outcome_type":"primary","measure":"AUC(0-144h)","time_frame":"144 hours post-dose on Day 1,22","description":"Area Under the Plasma Concentration-Time Curve From Time 0 to 36 hours Postdose for amitriptyline"}]}
{"nct_id":"NCT03483168","start_date":"2018-04-01","phase":"N/A","enrollment":29,"brief_title":"Culturally Sensitive Pain Education Program for Turkish Patients","official_title":"The Effects of Culturally Sensitive Pain Education Program in Turkish Patients With Chronic Low Back Pain: A Pilot Randomized Controlled Trial","primary_completion_date":"2018-10-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-10-01","last_update":"2018-10-05","description":"In last decade, the awareness has grown regarding the pain neuroscience education (PNE). In the literature, it has been found that there is strong evidence that the educational strategy of pain neuroscience education (PNE) can have positive effects on pain, disability, catastrophization, and physical performance in chronic musculoskeletal disorders. Nowadays, many physiotherapists integrate the PNE into the treatment of chronic pain. However, the importance of culturally sensitive approaches for the treatment of chronic pain has been proposed depending on the cultural differences of pain beliefs, pain cognitions, pain experiences and pain coping strategies in different ethnic populations. Therefore, the aim of this study is to compare the effects of a culturally sensitive PNE with a standard translated PNE on pain intensity, disability status, pain pressure thresholds and psychosocial factors (conceptualization of pain, pain beliefs, catastrophizing, kinesiophobia and illness perception) in Turkish patients with chronic low back pain (LBP). The effects of culturally sensitive PNE format will be compared with the standard translated PNE in a pilot trial. 40 Turkish patients (first generation migrant living around Ghent) with chronic LBP, between the age of 18 and 65 years, will be randomized to the culturally sensitive PNE or standard translated PNE. The content of 2 sessions PNE include the explanation about differences of acute and chronic pain, purpose of acute pain, production of acute pain and chronic pain, and potential sustaining factors for central sensitization, but presented in different ways. They will be subjected to an individual education session and they will receive a home education program. In session 2 (after 1 week), they will come back to ascertain that everything is understood.","other_id":"EC UZG 2018/0228","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  40 Turkish patients between the age of 18 and 65 years, with a diagnosis of\r\n             non-specific chronic LBP (have pain at least 3 months and mean pain frequency is 3 or\r\n             more days per week), who are diagnosed by a physician and not starting new\r\n             treatments,medication or continuing usual care 6 weeks prior and during study\r\n             participation will be included to the present study. First generation Turkish migrants\r\n             who are born in turkey, being Turkish as a first language, and being of Turkish\r\n             nationality will be eligible for inclusion in this study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with uncontrolled mental health condition (eg, schizophrenia, bipolar\r\n             disorder, major depressive disorder) that prevents the successful participation,\r\n             specific pathologies, trauma, or pregnancy will be excluded. Study participants will\r\n             be instructed to refrain from analgesics 48 hours prior to assessments.\r\n      ","sponsor":"Hacettepe University","sponsor_type":"Other","conditions":"Chronic Low Back Pain","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Culturally sensitive pain education","description":"The content of the PNE program include the characteristics of acute and chronic pain, purpose of acute pain, formation process of acute pain from the nervous system, the formation process of chronic pain, and potential sustaining factors for central sensitization."},{"intervention_type":"Behavioral","name":"Behavioral: Standard pain education program","description":"For the standard translated PNE, The English translation of \"Pain Neuroscience Education: slides for supporting and illustrating your explanation\" at the Pain in Motion Group web page (http://www.paininmotion.be/education/tools-for-clinical-practice) and English translation of the Patient Information Leaflet will be used. The education materials will be translated using the forward/backward translation process. The English version of PNE presentation and information leaflet will be translated to Turkish by two independent translators."}],"outcomes":[{"outcome_type":"primary","measure":"Pain intensity","time_frame":"change from baseline pain intensity at 4 week","description":"\"0-10\" Numerical Pain Scale"},{"outcome_type":"primary","measure":"Disability status","time_frame":"Change from baseline disability status at 4 week","description":"Disability status will be assessed by using the Roland Morris Disability Questionnaire ranging from 0 to 24; higher scores represent higher levels of pain-related disability."},{"outcome_type":"secondary","measure":"Pain Pressure Thresholds","time_frame":"change from baseline pain pressure thresholds at 4 weeks","description":"Pain pressure thresholds will be assessed with a hand held pressure algometer (Wagner Force 50) with a circular probe of one cm diameter. Perpendicular pressure will be applied at a constant rate (1kg/s) to the tissue surface. 3 pressure-points will be evaluated bilaterally: One pressure points are on the Erector spinae muscle mass at 5 cm laterally of the processus spinosus vertebrae of L3, one pressure pain is on the middle of the quadriceps muscle (between the anterior superior iliac spine and base of the patella), one pressure point is on the middle of the trapezius muscle (between acromion and processus spinosus of C7). Two measurements will be taken with a 30 second interval and the mean of the measurements will be recorded."},{"outcome_type":"secondary","measure":"Knowledge of pain","time_frame":"change from baseline pain knowledge at 4 weeks","description":"Knowledge of pain will be assessed by using the Revised Neurophysiology of Pain Questionnaire ranging from 0 to 13; higher scores represent higher levels of pain knowledge."},{"outcome_type":"secondary","measure":"Pain related beliefs","time_frame":"change from baseline pain beliefs at 4 weeks","description":"Pain related beliefs will be assessed by using the Pain Beliefs Questionnaire consisting of two subscales: Organic Beliefs and Psychological Beliefs. Scores for each subscale ranges from 1 to 6; higher scores represent that having more negative pain beliefs."},{"outcome_type":"secondary","measure":"Pain catastrophization","time_frame":"change from baseline pain catastrophization at 4 weeks","description":"Catastrophization of pain will be evaluated by using the Pain Catastrophizing Scale ranging from 0 to 52; higher scores represent higher levels of catastrophizing."},{"outcome_type":"secondary","measure":"Fear avoidance beliefs related to pain","time_frame":"change from baseline kinesiophobia at 4 weeks","description":"Fear avoidance will be evaluated by using the Tampa Scale for Kinesiophobia ranging from 17 to 68; higher scores represent higher levels of kinesiophobia."},{"outcome_type":"secondary","measure":"Illness perceptions","time_frame":"change from baseline illness perceptions at 4 weeks","description":"Illness perceptions will be evaluated by using the Brief Illness Perception Questionnaire; ranges from 0 to 80; higher scores represent a more threatening view of the illness."}]}
{"nct_id":"NCT04034849","start_date":"2018-04-01","phase":"N/A","enrollment":20,"brief_title":"Effects of Photobiomodulation in Burning Mouth Syndrome","official_title":"Effects of Photobiomodulation With Low-Level Laser Therapy in Burning Mouth Syndrome: A Randomized Clinical Trial","primary_completion_date":"2019-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-06-30","last_update":"2019-07-26","description":"The main objective of this study is to assess the effects of Photobiomodulation with Low-level Laser Therapy to the pain management in Burning Mouth Syndrome patients, besides assessing their impact on the different aspects of their quality of life, using the necessary questionnaires to evaluate all the outcomes of chronic pain.","other_id":"0003","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","intervention_model_description":"Randomized single blind placebo controlled study","sampling_method":"","gender":"All","minimum_age":31,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adult patients older than 18 years of age who fulfilled the International\r\n             Classification of Headache Disorders (ICHD-3) diagnostic criteria for Burning Mouth\r\n             Syndrome Exclusion Criteria\r\n\r\n          -  Patients not interested in participate in the study, unable to understand or answer\r\n             the questionnaires and follow the appointments, patients suffering hiposialia or\r\n             Sjgren's syndrome, patients who had received head and neck radiotherapy, pregnant\r\n             women, patients with uncontrolled systemic diseases (diabetes, thyroid diseases,\r\n             fibromyalgia or anemia) and patients suffering burning mouth symptoms secondary to\r\n             local factors\r\n      ","sponsor":"Rosa Mara Lpez-Pintor Muoz","sponsor_type":"Other","conditions":"Burning Mouth Syndrome","interventions":[{"intervention_type":"Radiation","name":"Radiation: Photobiomodulation","description":"Photobiomodulation whit Low-Level Laser Therapy"},{"intervention_type":"Radiation","name":"Radiation: Placebo","description":"Device turned off"}],"outcomes":[{"outcome_type":"primary","measure":"Changes in Visual Analogue Scale for Pain","time_frame":"Baseline (day 1), Session2 (day 4), Session 3 (day 8), Session 4 (day 11), Session 5 (day 15), Session 6 (day 18), Session 7 (day 22), Session 8 (day 25), Session 9 (day 29), Session 10 (day 32), 1st month follow-up (day 60), 4th month follow-up(day 150)","description":"Pain was assessed using a Visual Analogue Scale (0-10 cm) by the patients before starting each session and at two follow-up sessions, 1 and 4 months after finishing the treatment."},{"outcome_type":"secondary","measure":"Description of Pain: Mc Gill Pain Questionnaire validated to Spanish","time_frame":"Baseline (day 1), Session 10 (day 32), 1st month follow-up (day 60), 4th month follow-up (day 150)","description":"The patient is provided with a form comprising instructions and 20 word groups. The patient is instructed to read each word group and decide whether there is a work in the group which describes the pain he/she is experiencing there and then. The patient should circle one word in the group, which describes their pain. If there is no word in the group, which describes their pain, they are to move on to the next group until they have completed each of the 20 groups.\r\nGroups 1 to 10 are words used to describe sensory experience, groups 11 to 15 are affective words, 16 is evaluative and 17 to 20 are miscellaneous groups."},{"outcome_type":"secondary","measure":"General Health Short Form with the 36 Health Survery validated to Spanish","time_frame":"Baseline (day 1), Session 10 (day 32), 1st month follow-up (day 60), 4th month follow-up (day 150)","description":"The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health"},{"outcome_type":"secondary","measure":"Oral patient's quality of life with the Oral Health Impact Profile 14 validated to Spanish","time_frame":"Baseline (day 1), Session 10 (day 32), 1st month follow-up (day 60), 4th month follow-up (day 150)","description":"This questionnaire includes 14 questions about oral pain, physical, psychological, and social limitations and disabilities whose score range from 0 to 4. The total score varies from 0 to 56. Poorer scores correspond to low quality of life."},{"outcome_type":"secondary","measure":"Epworth sleepiness scale validated to Spanish","time_frame":"Baseline (day 1), Session 10 (day 32), 1st month follow-up (day 60), 4th month follow-up (day 150)","description":"The questionnaire asks the subject to rate his or her probability of falling asleep on a scale of increasing probability from 0 to 3 for eight different situations that most people engage in during their daily lives, though not necessarily every day. The scores for the eight questions are added together to obtain a single number. A number in the 0-9 range is considered to be normal while a number in the 10-24 range indicates that expert medical advice should be sought. For instance, scores of 11-15 are shown to indicate the possibility of mild to moderate sleep apnea, where a score of 16 and above indicates the possibility of severe sleep apnea or narcolepsy."},{"outcome_type":"secondary","measure":"Psychometris test Symptom Check List 90 validated to Spanish","time_frame":"Baseline (day 1), Session 10 (day 32), 1st month follow-up (day 60), 4th month follow-up (day 150)","description":"According to the overview given by the publisher, the SCL-90-R is normed on individuals 13 years and older. It consists of 90 items with options from 0 to 4 and takes 12-15 minutes to administer, yielding nine scores along primary symptom dimensions and three scores among global distress indices. The primary symptom dimensions that are assessed are somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, and a category of \"additional items\" which helps clinicians assess other aspect of the clients symptoms (e.g. item 19, \"poor appetite\"). The three indices are global wellness index, hardiness, and symptom free. The higher scores, the poorer psychological status."}]}
{"nct_id":"NCT04537065","start_date":"2018-04-01","enrollment":140,"brief_title":"Long Term Outcome of Intravitreal Ranibizumab for ROP","official_title":"Refractive and Biometric Outcome Following Intravitreal Injection of Ranibizumab in Retinopathy of Prematurity: Long -Term Study","primary_completion_date":"2018-09-01","study_type":"Observational","rec_status":"Completed","completion_date":"2018-09-01","last_update":"2020-09-03","description":"premature infants who had a history of intravitreal injection of (Ranibizumab) not less than one year were examined for refractive state and biometry","other_id":"Intravitreal Ranibizumab","observational_model":"Case-Control","time_perspective":"Other","sampling_method":"Non-Probability Sample","gender":"All","population":"Medical records of premature infants were collected from Egyptian Neonatal Network (EGNN)\r\n        data base","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  premature infants who had a history of intravitreal injection of (Ranibizumab) not\r\n             less than one year\r\n\r\n          -  Three control groups with age and sex matched were included for comparison. First\r\n             group included premature infants who had ROP that regressed spontaneously without\r\n             intervention. Second group was corresponded to premature infants who were diagnosed to\r\n             have normal retinal vasculature from the first examination after birth. The third\r\n             group belonged to full term babies\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Premature infants who received intravitreal injection of (Ranibizumab) less than one\r\n             year or had any ocular pathology\r\n      ","sponsor":"Ameera Gamal Abdelhameed","sponsor_type":"Other","conditions":"Retinopathy of Prematurity","interventions":[{"intervention_type":"Other","name":"Other: cycloplegic refraction","description":"Cycloplegic refraction and the average corneal radius of curvature were performed using a handheld auto kerato-refractometer (Righton Retinomax K-plus2). Refraction was confirmed by retinoscopy and refractive errors were calculated as spherical equivalent and astigmatism in cylinder.\r\nThe biometric optic components, including anterior chamber depth, lens thickness, and axial length, were measured using A-scan ultrasound (model Echoscan US-4000 / 500; Nidek)."}],"outcomes":[{"outcome_type":"primary","measure":"cycloplegic refraction","time_frame":"1 year after injection","description":"Cycloplegic refraction and the average corneal radius of curvature were performed using a handheld auto kerato-refractometer (Righton Retinomax K-plus2). Refraction was confirmed by retinoscopy and refractive errors were calculated as spherical equivalent and astigmatism in cylinder"},{"outcome_type":"primary","measure":"biometry","time_frame":"1 year after injection","description":"The biometric optic components, including anterior chamber depth, lens thickness, and axial length, were measured using A-scan ultrasound (model Echoscan US-4000 / 500; Nidek). Examination under sedation was performed for uncooperative children."}]}
{"nct_id":"NCT03186261","start_date":"2018-04-01","phase":"Phase 3","enrollment":44,"brief_title":"Antibacterial Effect of Nano Silver Fluoride vs Chlorhexidine on Occlusal Carious Molars Treated With Partial Caries Removal Technique","official_title":"Evaluation of the Antibacterial Effect of Nano Silver Fluoride Versus Chlorhexidine on Occlusal Carious Molars Treated With Partial Caries Removal Technique: A Randomized Clinical Trial","primary_completion_date":"2018-11-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-12-28","last_update":"2021-09-16","description":"- The teeth of the patients that meet inclusion criteria will be anesthetized, isolated with a rubber dam. - Cavity opened using conventional high-speed rotary instruments. - The central cariogenic biomass and the superficial parts of the necrotic dentine will be removed with round burs. - Caries lesion will be completely removed in the enamel/dentin junction. - The excavation procedure will be terminated as soon as the soft and wet dentine was removed and the remaining tissue was leathery but not hard on exploring. - A dentinal sample will then be collected from the base of the cavity using sterile spoon excavator as a baseline for bacteriological assessment. - Then, application of either intervention or control agent, another dentinal sample will be collected using a sterile excavator and transferred into sterile tubes and transferred to the laboratory for microbiological analysis. - Filling of the cavity with resin composite restoration. - All clinical procedures will be carried out at the same visit.","other_id":"amshamaa","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Inclusion Criteria of participants:\r\n\r\n               1. Not received antibiotic therapy since 1 month before sampling.\r\n\r\n               2. Good oral hygiene.\r\n\r\n               3. Co-operative patients approving the trial.\r\n\r\n          -  Inclusion Criteria of teeth:\r\n\r\n               1. Class I deep caries lesions in permanent molar (reaching  1/2 of the dentin on\r\n                  radiographic examination).\r\n\r\n               2. Absence of spontaneous pain; negative sensitivity to percussion; and absence of\r\n                  periapical lesions (radiographic examination).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Exclusion criteria of participants:\r\n\r\n               1. Pregnancy.\r\n\r\n               2. Systemic disease or severe medical complications.\r\n\r\n               3. Heavy smoking.\r\n\r\n               4. Xerostomia.\r\n\r\n               5. Lack of compliance.\r\n\r\n          -  Exclusion criteria of teeth:\r\n\r\n               1. Class II caries lesion.\r\n\r\n               2. Shallow or enamel caries.\r\n\r\n               3. Cuspal loss or caries beneath the gingival margin.\r\n      ","sponsor":"Cairo University","sponsor_type":"Other","conditions":"Dental Caries","interventions":[{"intervention_type":"Drug","name":"Drug: Nano silver fluoride solution","description":"Nano silver fluoride that composed of silver nanoparticles, chitosan and fluoride that combines preventive and antimicrobial properties."},{"intervention_type":"Drug","name":"Drug: Cavity Cleanser","description":"Moistens dentin surface after cavity preparation using a micro brush."}],"outcomes":[{"outcome_type":"primary","measure":"Bacterial Count of Streptococus Mutans","time_frame":"5 minutes on average between baseline and after application of the solution","description":"Digital Colony Counter, Agar Diffusion test"}]}
{"nct_id":"NCT03750591","start_date":"2018-03-31","enrollment":1000,"brief_title":"Observational Study on Effectiveness and Safety of Integrative Korean Medicine Treatment for Inpatients With Sciatica Due to Lumbar Intervertebral Disc Herniation","official_title":"Observational Study on Effectiveness and Safety of Integrative Korean Medicine Treatment for Inpatients With Sciatica Due to Lumbar Intervertebral Disc Herniation","primary_completion_date":"2019-05-10","study_type":"Observational [Patient Registry]","rec_status":"Completed","completion_date":"2019-11-08","last_update":"2020-03-13","description":"Observational study on the effectiveness and safety of integrative Korean medicine treatment for inpatients with sciatica due to lumbar intervertebral disc herniation","other_id":"JS-CT-2017-05-1","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":19,"maximum_age":70,"population":"Patients who are admitted or scheduled to be admitted to Jaseng Hospital of Korean\r\n        Medicine, Bucheon Jaseng Hospital of Korean Medicine, Daejeon Jaseng Hospital of Korean\r\n        Medicine, or Haeundae Jaseng Hospital of Korean Medicine","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Lumbar intervertebral disc herniation as confirmed by a doctor of medicine or a doctor\r\n             of Korean medicine through an MRI taken within 3 years\r\n\r\n          2. Patients with radiculopathy (ipsilateral or bilateral radiculopathy)\r\n\r\n          3. Patients whose pain intensity of back pain or radiating leg pain is NRS5\r\n\r\n          4. Patients aged 19 to 70\r\n\r\n          5. Patients who have agreed to participate in the clinical study and given written\r\n             informed consent\r\n\r\n          6. Patients admitted to a Korean medicine hospital for treatment\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients who have been diagnosed with a serious disease that may cause low back pain\r\n             or neck pain (e.g. spinal metastasis of tumor, acute fracture, spinal dislocation)\r\n\r\n          2. Patients admitted due to pain caused by traffic accidents\r\n\r\n          3. Patients with progressive neurological deficit or severe neurological symptoms such as\r\n             spinal cord injury\r\n\r\n          4. Patients with severe mental illness\r\n\r\n          5. Patients with difficulty or refusal to give sign written informed consent\r\n\r\n          6. Patients for whom the researchers judge participation in the clinical study to be\r\n             difficult\r\n\r\n          7. Diagnosis of lumbar spondylolisthesis of Meyerding  or higher by a doctor of medicine\r\n             or doctor of Korean medicine through X-ray or MRI\r\n      ","sponsor":"Jaseng Medical Foundation","sponsor_type":"Other","conditions":"Sciatica Due to Intervertebral Disc Disorder|Intervertebral Disc Displacement|Sciatica|Sciatic Radiculopathy","interventions":[{"intervention_type":"Procedure","name":"Procedure: Cupping","description":"Cupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points."},{"intervention_type":"Procedure","name":"Procedure: Pharmacopuncture","description":"Pharmacopuncture consisting of select herbal ingredients will be administered at Ah-shi points and local acupuncture points using disposable injection needles (CPL, 1 cc, 26gauze(G) x 1.5 syringe, Shinchang medical co., Korea)."},{"intervention_type":"Procedure","name":"Procedure: Acupuncture","description":"Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points."},{"intervention_type":"Drug","name":"Drug: Herbal medicine","description":"Herbal medicine will be mainly administered in water-based decoction (120ml) and dried powder (2g) form (the ingredients are mainly, but not restricted to: Ostericum koreanum, Eucommia ulmoides, Acanthopanax sessiliflorus, Achyranthes japonica, Psoralea corylifolia, Saposhnikovia divaricata, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, Glycine max, Atractylodes japonica)."},{"intervention_type":"Procedure","name":"Procedure: Chuna manual therapy","description":"Chuna is a Korean spinal manipulation that incorporates spinal manipulation techniques for joint mobilization involving highvelocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement.\r\nChuna manipulation will be administered at the physician's discretion."},{"intervention_type":"Procedure","name":"Procedure: Bee venom pharmacopuncture","description":"Bee venom pharmacopuncture will be administered only after confirming a negative response to hypersensitivity skin test.\r\nDiluted bee venom (saline:bee venom ratio, 10,000:1) filtered for allergens will be injected at 4-5 acupoints proximal to the dysfunctional site at the physician's discretion. Each acupuncture point will be injected to a total of 0.5-1 cc using disposable injection needles (CPL, 1 cc, 26gauze(G) x 1.5 syringe, Shinchang medical co., Korea)."},{"intervention_type":"Procedure","name":"Procedure: Electroacupuncture","description":"Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points."},{"intervention_type":"Other","name":"Other: Other intervention(s)","description":"Patients will be allowed any other additional intervention(s) as deemed necessary by the attending physician regardless of type or dose, and patterns of use will be investigated and recorded as an pragmatic clinical study."}],"outcomes":[{"outcome_type":"primary","measure":"NRS change from Baseline NRS at discharge","time_frame":"Baseline (admission), discharge (up to 14 weeks after baseline)","description":"Numeric rating scale (NRS) of low back pain, and radiating leg pain In pain measurement using NRS, patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 which indicates 'no pain', and 10 which indicates 'worst pain possible'."},{"outcome_type":"primary","measure":"ODI change from Baseline ODI at discharge","time_frame":"Baseline (admission), discharge (up to 14 weeks after baseline)","description":"Oswestry Disability Index(ODI) The ODI evaluates functional impairment and is a 10-item questionnaire developed to assess the level of disability due to back pain. Each item is graded into 6 levels, each representing a score of 0-5. Higher scores indicate greater limitation relating to back pain."},{"outcome_type":"primary","measure":"PGIC","time_frame":"6 months after baseline","description":"Patient global impression of change (PGIC) PGIC grades the level of subjective improvement into 7 levels (1, very much improved; 2, much improved; 3, slightly improved; 4, no change; 5, slightly worse; 6, much worse; and 7, very much worse)."},{"outcome_type":"secondary","measure":"EQ-5D change from Baseline EQ-5D at each time point","time_frame":"Baseline (admission), 2 weeks after baseline, discharge (up to 14 weeks after baseline), 6 months after baseline","description":"EuroQol-5 Dimension(EQ-5D) EQ-5D is a tool developed for health-related quality of life (HRQoL) assessment, and is widely used in the health care sector. Scores range from -1, 'health worse than death' to 1, 'perfect health'. EQ-5D-5L has 5 dimensions covering current health status and functionality: mobility (M), self care (SC), usual activities (UA), pain/discomfort (PD), and anxiety/depression (AD), to be rated out of 5 grades (1, no problem; 2, slight problem; 3, some/moderate problem; 4, severe problem; 5, extreme problem)."},{"outcome_type":"secondary","measure":"Lumbar ROM from Baseline Lumbar ROM at each time point","time_frame":"Baseline (admission), 2 weeks after baseline, discharge (up to 14 weeks after baseline)","description":"Lumbar Range of Motion(ROM) (Flexion/Extension/Lateral flexion/Rotation) Pain upon movement in lumbar range of motion (ROM) will be assessed."},{"outcome_type":"secondary","measure":"SLR from Baseline SLR at each time point","time_frame":"Baseline (admission), 2 weeks after baseline, discharge (up to 14 weeks after baseline)","description":"Straight Leg Raise test(SLR) The straight leg raise(SLR)is a test done during a physical examination to determine whether a patient with low back pain has an underlying herniated disc, often located at L5 (fifth lumbar spinal nerve).\r\nIf the patient experiences sciatic pain when the straight leg is at an angle of between 30 and 70 degrees, then the test is positive and a herniated disk is a possible cause of the pain.[3] A negative test suggests a likely different cause for back pain."},{"outcome_type":"secondary","measure":"AE","time_frame":"up to 14 weeks after baseline","description":"Adverse events(AE) Physicians will monitor and record any unexpected or unintended patient reaction to integrative korean medicine at each visit. Adverse events (AEs) associated with integrative korean medicine will include, but not be limited to, AEs anticipated from previous reports of korean medicine, and will stay open to all possibilities taking into consideration other potential, unknown AEs."},{"outcome_type":"secondary","measure":"NRS change from Baseline NRS at each timepoint","time_frame":"Baseline (admission), 2 weeks after baseline, 6 months after baseline","description":"Numeric rating scale (NRS) of low back pain, and radiating leg pain In pain measurement using NRS, patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 which indicates 'no pain', and 10 which indicates 'worst pain possible'."},{"outcome_type":"secondary","measure":"ODI change from Baseline ODI at each timepoint","time_frame":"Baseline (admission), 2 weeks after baseline, 6 months after baseline","description":"Oswestry Disability Index(ODI) The ODI evaluates functional impairment and is a 10-item questionnaire developed to assess the level of disability due to back pain. Each item is graded into 6 levels, each representing a score of 0-5. Higher scores indicate greater limitation relating to back pain."}]}
{"nct_id":"NCT03473041","start_date":"2018-03-31","phase":"Phase 3","enrollment":140,"brief_title":"Autologous Rectus Sheath Fascia Versus Midurethral Transobturator Tension Free Vaginal","official_title":"Surgeon Tailored Hybrid Autologus Rectus Sheath Fascia Versus Midurethral Transobturator Tension Free Vaginal Tape For Treatment Of Stress Urinary Incontinence","primary_completion_date":"2019-09-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-09-30","last_update":"2018-03-21","description":"a hybrid sling formed of a central part of autologus rectus sheath (26 cm) and two arms of polypropylene mesh (210cm) versus transobturator tension free vaginal tape(TVT-O)","other_id":"783","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":25,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  stress urinary incontinence\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  previous surgery for stress incontinence\r\n      ","sponsor":"sarah mohamed hassan","sponsor_type":"Other","conditions":"Stress Urinary Incontinence","interventions":[{"intervention_type":"Procedure","name":"Procedure: Hybrid sling","description":"sling formed of surgeon tailored autologous rectus sheath and polypropylene arms"},{"intervention_type":"Procedure","name":"Procedure: TVT-O","description":"midurethral transobturator vaginal tape"}],"outcomes":[{"outcome_type":"primary","measure":"cure rate","time_frame":"1 year follow up","description":"negative cough stress test"}]}
{"nct_id":"NCT03497026","start_date":"2018-03-30","phase":"N/A","enrollment":4,"brief_title":"Auris Robotic Endoscopy System for Bronchoscopy","official_title":"A Single-Center, Prospective, Single Arm Study to Evaluate the Performance of the Auris Robotic Endoscopy System for Bronchoscopic Procedures","primary_completion_date":"2018-07-10","study_type":"Interventional","rec_status":"Terminated","completion_date":"2018-07-10","last_update":"2021-09-17","description":"In this study, the performance related to the use of the novel Robotic Endoscopy Platform during bronchoscopic procedures will be evaluated.","other_id":"DD082015","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. 18 to 80 years of age;\r\n\r\n          2. Capable and willing to give informed consent;\r\n\r\n          3. Acceptable candidate for an elective, non-emergent bronchoscopic procedure;\r\n\r\n          4. Solid peripheral lung lesions suspected of malignancy, between 1.5-7cm in size\r\n             identified on thin slice CT scan with 30 days of the intended bronchoscopy\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Medical contraindication to bronchoscopy;\r\n\r\n          2. Ground glass opacity lesions on pre-procedure CT\r\n\r\n          3. Participation in any other clinical trial 30 days before and throughout the duration\r\n             of the study;\r\n\r\n          4. Uncontrolled or irreversible coagulopathy;\r\n\r\n          5. Female subjects who are pregnant or nursing or those of child-bearing potential\r\n             refusing a pregnancy test;\r\n\r\n          6. CT scan done over a month before the bronchoscopy procedure.\r\n\r\n        Intra-Procedure Exclusion Criteria: Any presenting condition discovered intra-procedurally\r\n        that in the opinion of the investigator would make participating in this study not in the\r\n        patient's best interest.\r\n      ","sponsor":"Auris Health, Inc.","sponsor_type":"Industry","conditions":"Lung Cancer","interventions":[{"intervention_type":"Device","name":"Device: Robotic Bronchoscopy Platform","description":"Eligible patients will undergo the robotic bronchoscopy for evaluation of suspected lung nodules."}],"outcomes":[{"outcome_type":"secondary","measure":"Identification of correct bronchi leading to the targeted lesions","time_frame":"During the procedure","description":"The principal investigator will assess the capabilities of the navigation to identify optimal path to the targeted lesion."},{"outcome_type":"primary","measure":"Completion of the intended bronchoscopic procedure with the Robotic Endoscopy Platform","time_frame":"During the procedure","description":"Completion of the intended bronchoscopic procedure is defined by the ability to acquire tissue with biopsy tools."},{"outcome_type":"primary","measure":"Incidence of device or procedure related Adverse Events","time_frame":"6 weeks","description":"Calculate from the rate between number of patients with device or procedure related adverse events and number of patients who underwent the robotic bronchoscopy procedure."},{"outcome_type":"secondary","measure":"Ability to localize targeted lesion","time_frame":"During the procedure","description":"Radial probe endobronchial ultrasound will be used in all cases to confirm the presence of a lesion immediately before performing biopsy."},{"outcome_type":"secondary","measure":"Alignment capabilities","time_frame":"During the procedure","description":"Calculate from the sum of results that were positive for the first attempt of tissue acquisition divided by the sum of all attempts."},{"outcome_type":"secondary","measure":"Time to REBUS confirmation","time_frame":"During the procedure","description":"Defined by the time the robotic bronchoscope is inserted into the oropharynx until the localization of the targeted lesion is confirmed by REBUS"},{"outcome_type":"secondary","measure":"Time to the tissue acquisition confirmation","time_frame":"During the procedure","description":"Defined by the time the robotic bronchoscope is inserted into the oropharynx until the tissue acquisition is confirmed by the Rapid On Site Evaluation (ROSE)."},{"outcome_type":"secondary","measure":"Total procedure time","time_frame":"During the procedure","description":"Total procedure time is defined by the time the robotic bronchoscope is inserted into the oropharynx until the time a biopsy tool is removed."},{"outcome_type":"secondary","measure":"Diagnostic yield","time_frame":"6 weeks","description":"Calculate from the sum of results that were diagnostically positive for malignancy and the sum of the results that were diagnostically negative for malignancy based o n the sum of all targets."},{"outcome_type":"secondary","measure":"Conversion to conventional bronchoscopic procedure","time_frame":"During the procedure","description":"Calculate from the rate between number of procedures with robotic bronchoscope and number of procedures converted to conventional bronchoscopy"},{"outcome_type":"secondary","measure":"Anesthesia time","time_frame":"During the procedure","description":"Total anesthesia time"},{"outcome_type":"secondary","measure":"Incidence of complications unrelated to device","time_frame":"6 weeks","description":"Calculate from the rate between number of patients with complications unrelated to device and number of patients who underwent the robotic bronchoscopy procedure."}]}
{"nct_id":"NCT03190863","start_date":"2018-03-29","phase":"N/A","enrollment":21,"brief_title":"Grasping Rehabilitation Using Motor Imagery With or With no Neurofeedback After Tetraplegia","official_title":"Investigating the Effect of Motor Imagery With or With no Visual Neurofeedback on Grasping Capabilities After C6-C7 Tetraplegia: a Multicentric Randomized Controlled Trial.","primary_completion_date":"2023-05-29","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-05-29","last_update":"2020-12-17","description":"Motor imagery has shown promising results to optimize tenodesis grasp in individuals with C6-C7 tetraplegia. However, efficacy of using motor imagery to improve grasping after tetraplegia requires further study with higher level of evidence. In addition, controlling covert practice remains difficult due to the absence of overt movements. However, similar brain activity measured during both over and cover movements makes possible to provide visual information about the covert practice performance using neurofeedback. The Investigators thus designed this multicentric randomized controlled trial to investigate the effect of motor imagery with or with no visual neurofeedback on grasping capabilities after C6-C7 tetraplegia. They hypothesized that providing neurofeedback based on brain activity measured by electroencephalography namely knowing the covert practice performance would results in greater grasping improvement in response to practice as compared to motor imagery practice alone.","other_id":"69HCL17_0016","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Volunteer individuals with C6-C7 tetraplegia with complete finger flexor paralysis\r\n             restricting grasping capabilities to the tenodesis.\r\n\r\n          -  Consent to participate to the study after receiving clear, loyal and appropriate\r\n             information.\r\n\r\n          -  Aged between 18 and 55 years.\r\n\r\n          -  Time since spinal cord injury above 6 months\r\n\r\n          -  Stabilized condition in particular sensori-motor deficit.\r\n\r\n          -  Sitting position for more than 1 hour\r\n\r\n          -  Able to imagine movement\r\n\r\n          -  Health care beneficiary\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Long-lasting autonomic disorders while sitting (orthostatic hypotension and/or blood\r\n             pressure instability) limiting sitting position to less than 1 hour.\r\n\r\n          -  Upper limb pain for either mechanic or neuropathic reasons preventing all grasping\r\n             movement and/or the ability to imagine those movements.\r\n\r\n          -  Restricted wrist and finger range of motion preventing the tenodesis grasp.\r\n\r\n          -  Patient after surgical tendon transfer that improved grasping capabilities (e.g.\r\n             active finger flexion).\r\n\r\n          -  Ongoing participation in another research that aim to evaluate an intervention likely\r\n             to improve the neurological or functional recovery introducing an experimental bias.\r\n\r\n          -  Specific contraindication to Magnetoencephalography with the presence of metallic\r\n             fragments inside the body such as pace-maker, neurostimulator, cochlear implants,\r\n             steel dental implant and osteosynthesis material only applicable to the participants\r\n             included in Lyon hospital center (n=15).\r\n      ","sponsor":"Hospices Civils de Lyon","sponsor_type":"Other","conditions":"Individuals With C6-C7 Tetraplegia (AIS A or B)","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Motor imagery combined with neurofeedback (MINF)","description":"7 individuals with C6-C7 tetraplegia randomize in the experimental group consisting in motor imagery practice combined with visual neurofeedback (NF - i.e. performance of the imagined movement).\r\nIntervention consists in a total of 15 sessions repeated 3 times a week and lasting 5 weeks. Each session will last 45 minutes. An experienced physical therapist supervised all sessions. After each imagined movement, the NF based on brain activity measured by electroencephalography is display on a screen."},{"intervention_type":"Behavioral","name":"Behavioral: Motor imagery (MI)","description":"7 individuals with C6-C7 tetraplegia randomized in the active comparator group consisting in motor imagery practice alone without visual NF. This means that the performance of the imagined movement is not displayed to the participants.\r\nIntervention consists in a total of 15 sessions repeated 3 times a week and lasting 5 weeks. Each session will last 45 minutes. An experienced physical therapist supervised all sessions."},{"intervention_type":"Behavioral","name":"Behavioral: Control (C)","description":"7 individuals with C6-C7 tetraplegia randomized in the sham comparator group consisting in imagining geometric shapes by visualization. Shapes are successively displayed on a screen.\r\nIntervention consists in a total of 15 sessions repeated 3 times a week and lasting 5 weeks. Each session will last 45 minutes. An experienced physical therapist supervised all sessions."}],"outcomes":[{"outcome_type":"primary","measure":"Wrist extension angle in degree during grasping with 3D motion analysis system","time_frame":"Up to 19 weeks","description":"Individuals with C6-C7 tetraplegia extend their wrist to grasp using tenodesis. Specifically, the wrist extension shortens the tendons of fingers and thumbs flexors that elicit either a palmar or a lateral grip. A complete reach-to-grasp movement will be recorded using a 3D motion analysis system (Vicon Motion Systems Ltd. UK). Wrist extension angle in degree will be measure during grasping when the object is grasped."},{"outcome_type":"secondary","measure":"Temporal kinematic parameters of reach-to-grasp movements with 3D motion analysis system (Vicon Motion Systems Ltd. UK).","time_frame":"Up to 19 weeks","description":"Computation of temporal kinematic parameters (e.g. movement duration) measured during a complete reach-to-grasp movement using a 3D motion analysis system (Vicon Motion Systems Ltd. UK). Temporal parameters are also aggregated with spatial parameters."},{"outcome_type":"secondary","measure":"Spatial kinematic parameters of reach-to-grasp movements with 3D motion analysis system (Vicon Motion Systems Ltd. UK).","time_frame":"Up to 19 weeks","description":"Computation of spatial kinematic parameters (e.g. movement trajectory) measured during a complete reach-to-grasp movement using a 3D motion analysis system (Vicon Motion Systems Ltd. UK).Spatial parameters are also aggregated with temporal parameters."},{"outcome_type":"secondary","measure":"Brain activity change in response to intervention using magnetoencephalography","time_frame":"Up to 19 weeks","description":"Brain activity will be measured during upper limb movement (e.g. a complete reach-to-grasp movement) using magnetoencephalography. The device is only available in Lyon Hospital. Correspondingly, fifteen participants included in Lyon Hospital will achieve this measure."},{"outcome_type":"secondary","measure":"passive upper limb range of motion (ROM) measured using goniometer and/or inclinometer","time_frame":"Up to 19 weeks","description":"This outcome will be measured using goniometer and/or inclinometer by the same blind and experienced physical therapist"},{"outcome_type":"secondary","measure":"Upper limb strength measured using the hand held dynamometer","time_frame":"Up to 19 weeks","description":"This outcome will be measured using the manual muscle test and the hand held dynamometer by the same blind and experienced physical therapist."},{"outcome_type":"secondary","measure":"Upper limb strength measured using the manual muscle test","time_frame":"Up to 19 weeks","description":"This outcome will be measured using the manual muscle test and the hand held dynamometer by the same blind and experienced physical therapist."},{"outcome_type":"secondary","measure":"Hand dexterity measured using the Box and Block test","time_frame":"Up to 19 weeks","description":"This outcome will be measured using i) the Box and Block Test, ii) the Nine Hole Peg Test, iii) the Jebsen Test and iv) the Capability of Upper Limb Test supervised by the same blind and experienced occupational therapist"},{"outcome_type":"secondary","measure":"Hand dexterity measured using the Nine Hole Peg test","time_frame":"Up to 19 weeks","description":"This outcome will be measured using i) the Box and Block Test, ii) the Nine Hole Peg Test, iii) the Jebsen Test and iv) the Capability of Upper Limb Test supervised by the same blind and experienced occupational therapist"},{"outcome_type":"secondary","measure":"Hand dexterity measured using the Jebsen test","time_frame":"Up to 19 weeks","description":"This outcome will be measured using i) the Box and Block Test, ii) the Nine Hole Peg Test, iii) the Jebsen Test and iv) the Capability of Upper Limb Test supervised by the same blind and experienced occupational therapist"},{"outcome_type":"secondary","measure":"Hand dexterity measured using the Capability of Upper Limb test","time_frame":"Up to 19 weeks","description":"This outcome will be measured using i) the Box and Block Test, ii) the Nine Hole Peg Test, iii) the Jebsen Test and iv) the Capability of Upper Limb Test supervised by the same blind and experienced occupational therapist"},{"outcome_type":"secondary","measure":"Quality of Life measured using the WHOQOL-Bref","time_frame":"Up to 19 weeks","description":"This outcome will be measured using the WHOQOL-Bref by the same blind and experienced physical therapist."},{"outcome_type":"secondary","measure":"Daily life autonomy measured using the Quadriplegic Index of Function","time_frame":"Up to 19 weeks","description":"This outcome will be measured using the Quadriplegic Index of Function by the same blind and experienced physical therapist."},{"outcome_type":"secondary","measure":"Motor imagery capability measured by the Kinesthetic Visual Imagery Questionnaire","time_frame":"Up to 19 weeks","description":"Motor imagery capability will be measured by the Kinesthetic Visual Imagery Questionnaire by the same blind and experienced physical therapist along with comparing overt and covert movement duration, galvanic skin response, electroencephalography activity."}]}
{"nct_id":"NCT03496857","start_date":"2018-03-28","phase":"N/A","enrollment":60,"brief_title":"Effect of LED Photobiomodulation on Analgesia During Labor","official_title":"Effect of LED Photobiomodulation on Analgesia During Labor: a Randomized Clinical Trial","primary_completion_date":"2018-08-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2018-11-20","last_update":"2018-04-12","description":"The aim of this study is to valuate the effects of LED photobiomodulation on analgesia during labor.ight-emitting diode (LED) photobiomodulation is an effective and noninvasive alternative to pharmacological methods.n total, 60 women in labor admitted to a public maternity hospital will be selected for a randomized controlled trial. The participants will be randomized into two groups: intervention group [analgesia with LED therapy (n = 30)] and control group [analgesia with bath therapy (n = 30)].","other_id":"PhotobioLabor01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","intervention_model_description":"RANDOMIZED CLINICAL TRIAL","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  women who request analgesia during labor\r\n\r\n          -  nulliparous and multiparous\r\n\r\n          -  women with term gestation\r\n\r\n          -  women without previous diseases, including diabetes, neurological diseases.\r\n\r\n        Exclusion Criteria:T\r\n\r\n          -  women whose labor is induced with medications;\r\n\r\n          -  women who request drug analgesia during labor;\r\n\r\n          -  women who undergo cesarean delivery\r\n      ","sponsor":"University of Nove de Julho","sponsor_type":"Other","conditions":"Labor Pain","interventions":[{"intervention_type":"Device","name":"Device: Light emitting diode","description":"Three 10-min LED applications will be performed when the patient has a cervical dilatation of 4-5, 6-7, and 8-9 cm. Data on the level of pain, characteristics of the membrane (intact or damaged), heart rate, cardiotocography, and uterine dynamics will be collected after each intervention."},{"intervention_type":"Other","name":"Other: Bath Therapy","description":"The method of analgesia with the bath therapy will be performed using a hot shower at 37C for 10 min. After showering the entire body or the back for 5 min, the participants will be allowed to direct the water flow to any area of the body that feels the most comfortable and to adjust the temperature themselves for improved comfort. Bath therapy will be performed at three time points during labor: at cervical dilatation of 4-5 cm, 6-7 cm, and 8-9 cm. Data on the level of pain, membrane characteristics (intact or damaged), heart rate, cardiotocography, and uterine dynamics will be collected after the bath therapy by performing the same measurements used in the intervention group."}],"outcomes":[{"outcome_type":"primary","measure":"Labor pain","time_frame":"20 minutes","description":"Visual Analogue Scale Pain"}]}
{"nct_id":"NCT03465163","start_date":"2018-03-27","phase":"N/A","enrollment":1,"brief_title":"A Deep Brain Stimulation System in Epilepsy: Tracking Neural Excitability","official_title":"Safety and Efficacy of a Deep Brain Stimulation System in Epilepsy: A Feasibility Study for Tracking Neural Excitability","primary_completion_date":"2020-07-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-07-01","last_update":"2020-10-27","description":"The main purpose of this research project is to evaluate the safety and effectiveness of a surgically implanted device called the Medtronic Activa PC+S System in patients with medically refractory epilepsy (people who have seizures that are not completely controlled by medical therapy). The system sends small electrical pulses into a part of the brain called the thalamus to help control seizures. It sends this signal in regularly, regardless of if a seizure is occurring. A different version of this device is already approved for the treatment of epilepsy in Australia. This study aims to use the brain's responses to single pulse electrical stimulation to measure the level of seizure susceptibility. The investigators would like to show that this measure can be used to provide more effective deep brain stimulation therapies, to stop seizures.","other_id":"HREC/17/SVHM/146","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Device Feasibility","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Patients with epilepsy with non-resectable pathologies, or clearly defined focal seizures\r\n        without a defined structural pathology.\r\n\r\n        Patients will be required to have a seizure diary (of up to 3 months) recording at least\r\n        five seizures per month that are well separated in time (at least 8 hours apart).\r\n\r\n        Exclusion Criteria:\r\n\r\n        Previous diagnosis of psychogenic/non-epileptic seizures\r\n      ","sponsor":"St Vincent's Hospital Melbourne","sponsor_type":"Other","conditions":"Epilepsy|Nodular Heterotopia","interventions":[{"intervention_type":"Device","name":"Device: Deep Brain Stimulation","description":"The device is called the Medtronic Activa PC+S system. Two devices will be implanted per participant. The electrodes will be surgically implanted bilaterally into the hippocampus and anterior nucleus of the thalamus."}],"outcomes":[{"outcome_type":"primary","measure":"Change in Seizure Rate","time_frame":"Recorded throughout the baseline (2-4 months post implant) and probe calibrated DBS phase( 6-8 months post implant)","description":"Comparing the number of seizures per patient, as recorded by Medtronic Activa PC+S system in the baseline vs. probe calibrated DBS phase."},{"outcome_type":"secondary","measure":"Determine if probing responses provide a seizure susceptibility measure.","time_frame":"Throughout probing phase (4-6 months post implant)","description":"Calculate probability of seizure in the near future given the features of the probing response shape during pre-ictal and inter-ictal periods on training dataset and then test predictive power on remaining data. Features defining the probing response shape will include peak amplitude and peak latency. Seizure occurrences will be determined by the Medtronic PC+S device."},{"outcome_type":"secondary","measure":"Change in brain excitability following DBS treatment, assessed according to changes in probing response energy before and after stimulation therapy.","time_frame":"Throughout probing phase (4-6 months post implant) and probe calibrated DBS phase (6-8 months post implant)."}]}
{"nct_id":"NCT03636633","start_date":"2018-03-21","phase":"N/A","enrollment":36,"brief_title":"The Effect of Inspiratory Muscle Training and Respiratory Physiotherapy on Pulmonary Functions, Respiratory Muscle Strength and Functional Capacity in Patients With Robotic Heart Surgery","official_title":"The Effect of Inspiratory Muscle Training and Respiratory Physiotherapy on Pulmonary Functions, Respiratory Muscle Strength and Functional Capacity in Patients With Robotic Heart Surgery","primary_completion_date":"2019-03-21","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-12-21","last_update":"2018-08-20","description":"During the past decade, especially with the advancement of technology, major innovations and developments have been observed in the field of surgery. Cardiac surgery is one of the important area of the surgery who renews itself day by day and adds innovations to the nature in terms of patients' comfort. One of the greatest developments in cardiac surgery in this sense is the tendency to reduce the size of the incisions with less interventional procedures. Robotic surgery is getting more and more meaningful in this area. Despite the downsizing of the surgical incisions, postoperative pulmonary complications have not completely disappeared in the robotic cardiac surgery. Major respiratory problems following traditional cardiac surgery are gas exchange problems, atelectasis, decreased coughing force and sputum retention. The effectiveness of respiratory physiotherapy applied after traditional cardiac surgery for the resolution of these complications has been proved by various investigations. Inspiratory muscle training (IMT) has been found to improve autonomic modulation in heart failure patients as well as to increase inspiratory muscle strength in applied patient populations, reduce blood pressure in hypertensive patients, and increase functional capacity in elderly individuals. Considering these benefits, when inspiratory muscle training is given to people with traditional cardiac surgery, respiratory muscle strengths, respiratory functions and functional capacities are increased compared to those not given to these patients. However, although there are complications after robotic cardiac surgery, there are no studies in the literature about respiratory physiotherapy or inspiratory muscle training. Thus, the subject of this study is the comparison of the effects of standard respiratory physiotherapy and standard respiratory physiotherapy plus inspiratory muscle training on the respiratory functions, respiratory muscle strength and functional capacity of the patients with the robotic heart surgery.","other_id":"ATADEK-2018-2/55","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Being suitable for robotic cardiac surgery,\r\n\r\n          -  Being hospitalized to have a robotic heart surgery,\r\n\r\n          -  No complications during surgery,\r\n\r\n          -  To be extubated in intensive care unite after surgery ,\r\n\r\n          -  Stable clinical condition,\r\n\r\n          -  To be transferred from ICU to the hospital room on the first day after surgery.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Chronic obstructive pulmonary disease,\r\n\r\n          -  Unstable angina,\r\n\r\n          -  Acute decompensated heart failure,\r\n\r\n          -  Acute pericarditis and myocarditis,\r\n\r\n          -  Complex arrhythmia,\r\n\r\n          -  Uncontrolled hypertension,\r\n\r\n          -  Serious orthopedic and neurological impairment,\r\n\r\n          -  Uncontrolled diabetes,\r\n\r\n          -  Body Mass Index > 30.\r\n      ","sponsor":"Acibadem University","sponsor_type":"Other","conditions":"Robotic Surgical Procedures|Heart Diseases","interventions":[{"intervention_type":"Other","name":"Other: Standard respiratory physiotherapy","description":"Standard respiratory physiotherapy content; diaphragmatic breathing, pursed lip breathing, segmental breathing, incentive spirometer exercises (Triflo) and coughing techniques."},{"intervention_type":"Other","name":"Other: Standard respiratory physiotherapy and inspiratory muscle training","description":"Standard respiratory physiotherapy content; diaphragmatic breathing, pursed lip breathing, segmental breathing, incentive spirometer exercises (Triflo) and coughing techniques. Addition to that, threshold IMT device will be used for the training. Training intensity will set at 40% of the maximum inspiratory pressure."}],"outcomes":[{"outcome_type":"primary","measure":"Change from baseline Forced Vital Capacity (FVC) at 4 weeks","time_frame":"Four weeks"},{"outcome_type":"primary","measure":"Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 4 weeks","time_frame":"Four weeks"},{"outcome_type":"primary","measure":"Change from baseline Peak Expiratory Flow (PEF) at 4 weeks","time_frame":"Four weeks"},{"outcome_type":"primary","measure":"Change from baseline maximum inspiratory pressure (MIP) at 4 weeks","time_frame":"Four weeks"},{"outcome_type":"primary","measure":"Change from baseline maximum expiratory pressure (MEP) at 4 weeks","time_frame":"Four weeks"},{"outcome_type":"primary","measure":"Change from baseline distance covered in six-minute walk test (6MWT) at 4 weeks","time_frame":"Four weeks"},{"outcome_type":"primary","measure":"Change from baseline carbon monoxide diffusion capacity of the lungs (DLCO) at 4 weeks","time_frame":"Four weeks"},{"outcome_type":"secondary","measure":"Fatigue Severity Scale","time_frame":"Four weeks","description":"The 9 item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. Assessment type: Patient reported outcomes.The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree.The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity."},{"outcome_type":"secondary","measure":"Fatigue Impact Scale","time_frame":"Four weeks","description":"The fatigue impact scale was developed to assess the symptom of fatigue as part of an underlying chronic disease or condition. Consisting of 40 items, the instrument evaluates the effect of fatigue on three domains of daily life: cognitive functioning, physical functioning, and psychosocial functioning. Respondents are asked to rate the extent to which fatigue has interfered with certain aspects of their day-to-day functioning using a scale that ranges from 0 (\"no problem\") to 4 (\"extreme problem\"). Scores are then tallied to produce an overall score with a potential maximum of 160. Subscale scores can also be calculated to give a more nuanced impression of fatigue."}]}
{"nct_id":"NCT03891004","start_date":"2018-03-20","phase":"N/A","enrollment":47,"brief_title":"Skin Closure With Tissue Adhesives vs. Subcuticular Suture After Robotic Urogynecologic Procedures","official_title":"Skin Closure With Tissue Adhesives vs. Subcuticular Suture After Robotic Urogynecologic Procedures","primary_completion_date":"2018-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-12-31","last_update":"2019-04-04","description":"To compare skin closure via subcuticular suture versus tissue adhesive (Dermabond) in urogynecological robotic surgeries. The primary outcome is incision cosmesis at the 12 week follow up visit. Secondary outcome is the operative time between the two methods of closure.","other_id":"StJohnHMedCtr","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","intervention_model_description":"This will be a randomized controlled trial comparing skin closure after robotic urogynecologic surgery with tissue adhesive versus subcuticular suture.","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":99,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Women, ages 18 years and older, undergoing any urogynecologic robotic procedure at St.\r\n             John Hospital and Medical Center from March 19, 2018 - November 30, 2018.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  We will exclude women with active skin infections as they may contribute to poor wound\r\n             healing and infections. We will also exclude procedures that are converted to\r\n             laparotomy.\r\n      ","sponsor":"St. John Hospital & Medical Center","sponsor_type":"Other","conditions":"Surgical Wound|Tissue Adhesion","interventions":[{"intervention_type":"Procedure","name":"Procedure: Subcuticular Skin Closure","description":"We will only close the subcuticular layer with suture"},{"intervention_type":"Device","name":"Device: Tissue Adhesives","description":"No subcuticular closure will be done. Only tissue adhesives applied to the approximated skin"}],"outcomes":[{"outcome_type":"primary","measure":"Incision Cosmesis","time_frame":"12 weeks","description":"Our primary outcome measure is to compare incision cosmesis between the two closure methods at the 12 week postoperative visit. The Stony Brook Scar Evaluation scale is used. A point is awarded in each of the following categories: width, height, color, hatch/suture marks, overall appearance. Poorer cosmesis is indicated by a lower score. Highest score possible is 5 points."},{"outcome_type":"secondary","measure":"Incision closure time","time_frame":"30 minutes","description":"The time of each closure method will be recorded and compared."}]}
{"nct_id":"NCT03406338","start_date":"2018-03-20","phase":"Phase 4","enrollment":56,"brief_title":"Fasciectomy vs Collagenase Injection in Recurrent Dupuytren Disease","official_title":"Surgical Fasciectomy Versus Collagenase Injection in Treating Recurrent Dupuytren Disease: a Randomized Controlled Trial","primary_completion_date":"2023-12-31","study_type":"Interventional","rec_status":"Enrolling by invitation","completion_date":"2026-12-31","last_update":"2020-11-03","description":"This randomized controlled trial will compare the outcome of surgery (fasciectomy) with that of local injection of Collagenase Clostridium Histolyticum in patients with recurrent finger joint contracture after previous treatment with Surgery, collagenase injection or needle fasciotomy. Half of the participants will be treated with surgery while the other half will receive collagenase injection.","other_id":"Hlm_DC","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","intervention_model_description":"Randomized parallel Group, ratio 1:1.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Seeking treatment for recurrence of Dupuytrens contracture in at least one finger.\r\n\r\n          -  Passive extension deficit of 30 degrees or greater in the metacarpophalangeal and/or\r\n             proximal interphalangeal joint in a finger previously treated with surgical\r\n             fasciectomy, collagenase injections, or needle fasciotomy.\r\n\r\n          -  Palpable cord in the palm and/or affected finger causing the recurrent contracture.\r\n\r\n          -  No Surgery, collagenase injection or needle fasciotomy in the finger with recurrent\r\n             contracture in the past 12 months.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Medical comorbidities that constitute a contraindication for surgical fasciectomy or\r\n             collagenase injection.\r\n\r\n          -  Signs of nerve or vascular injury in the affected finger.\r\n\r\n          -  Osteoarthritis in the metacarpophalangeal and/or proximal interphalangeal joint joint\r\n             in the affected finger\r\n\r\n          -  Complications after the previous treatment, such as infection or complex regional pain\r\n             syndrome (CRPS).\r\n\r\n          -  Previous trauma or other surgery involving the affected finger.\r\n\r\n          -  More than 2 previous surgeries, collagenase injections or needle fasciotomies in the\r\n             affected finger.\r\n\r\n          -  Examining surgeon deems further fasciectomy inappropriate or potentially associated\r\n             with very high complication risk, for example in severe contracture and/or severe\r\n             scarring after the previous surgeries and considers salvage procedures (such as\r\n             amputation) as the more appropriate treatment.\r\n\r\n          -  Patient refusal to participate\r\n      ","sponsor":"Region Skane","sponsor_type":"Other","conditions":"Dupuytren Disease of Finger","interventions":[{"intervention_type":"Procedure","name":"Procedure: Fasciectomy","description":"Surgical excision of Dupuytren cords causing finger joint contractures. Surgery done under regional or general anesthesia. Additional procedures (such as capsulotomy or skin graft) done if surgeon deemed necessary."},{"intervention_type":"Drug","name":"Drug: Collagenase Clostridium Histolyticum","description":"Injection of Collagenase into the Dupuytren cord after local anesthesia (nerve block) followed 24-48 hours later by finger manipulation after local anesthesia"}],"outcomes":[{"outcome_type":"secondary","measure":"Satisfaction score","time_frame":"3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months","description":"Visual analog scale of patient satisfaction with treatment outcome, score range from 0 (best) to 100 (worst)"},{"outcome_type":"secondary","measure":"Adverse events","time_frame":"Anytime during 24 months after treatment","description":"All observed and reported adverse events will be recorded on a standard form. Serious adverse events include nerve, artery or tendon damage, deep infection, complex regional pain syndrome and any complications requiring surgery or hospital admission."},{"outcome_type":"primary","measure":"Total active extension deficit (metacarpophalangeal plus proximal interphalangeal joints)","time_frame":"Change from baseline to 3 months","description":"Extension deficit of the metacarpophalangeal and interphalangeal joints of the treated finger measured with hand-held goniometer (0 degrees indicates no extension deficit)"},{"outcome_type":"primary","measure":"Proportion of patients with worsening in total active extension deficit ≥20 degrees","time_frame":"24 months compared to 3 months","description":"Extension deficit of the metacarpophalangeal and interphalangeal joints of the treated finger measured with hand-held goniometer (0 degrees indicates no extension deficit)"},{"outcome_type":"secondary","measure":"11-item disabilities of the arm, shoulder and hand (QuickDASH) score","time_frame":"Change over time from from baseline, 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months","description":"A patient-reported outcome measure of activity limitations related to upper extremity disorders, with total score range from 0 (best) to 100 (worst)"},{"outcome_type":"secondary","measure":"EuroQoL 5-dimensions (EQ-5D) Index","time_frame":"Change over time from from baseline, 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months","description":"Health-status and quality-of-life patient-reported measure, consists of 5 items, a single weighted score, the EQ-5D index, is calculated from the 5 dimensions, ranging from -0.594 (worst) to 1.0 (perfect health)"},{"outcome_type":"secondary","measure":"Pain score","time_frame":"Change over time from from baseline, 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months","description":"Visual analog scale of pain in the treated hand, score range from 0 (best) to 100 (worst)"},{"outcome_type":"secondary","measure":"Costs","time_frame":"From baseline through 24 months","description":"Total treatment cost, direct (medications, surgery, materials, visits etc) and indirect (sick leave related to the treatment)"},{"outcome_type":"secondary","measure":"Total active motion","time_frame":"Change from baseline to 3 months, 12 months, 24 months and 60 months","description":"Sum of active range of motion of metacarpophalangeal, proximal intephalangeal and distal interphalangeal joints of the treated finger"},{"outcome_type":"secondary","measure":"Total active extension deficit (metacarpophalangeal plus proximal interphalangeal joints)","time_frame":"Change from baseline to 12 months, 24 months and 60 months","description":"Active extension deficit of the metacarpophalangeal and interphalangeal joints of the treated finger measured with hand-held goniometer (0 degrees indicates no extension deficit)"},{"outcome_type":"secondary","measure":"Proportion of patients with worsening in total active extension deficit ≥20 degrees","time_frame":"60 months compared to 3 months","description":"Extension deficit of the metacarpophalangeal and interphalangeal joints of the treated finger measured with hand-held goniometer (0 degrees indicates no extension deficit)"},{"outcome_type":"secondary","measure":"Palmar pain score","time_frame":"Change over time from baseline to 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months.","description":"2-item scale inquiring about pain in the palm and related activity limitations, total score range 0 (best) to 100 (worst)"},{"outcome_type":"secondary","measure":"Cold intolerance symptom severity score","time_frame":"Change from baseline to 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months.","description":"6-item scale inquiring about symptoms of cold intolerance, total score range 4 (best) to 100 (worst)"},{"outcome_type":"secondary","measure":"Total passive extension deficit (metacarpophalangeal plus proximal interphalangeal joints)","time_frame":"Change from baseline to 24 months and 60 months","description":"Passive extension deficit of the metacarpophalangeal and interphalangeal joints of the treated finger measured with hand-held goniometer (0 degrees indicates no extension deficit)"}]}
{"nct_id":"NCT03369483","start_date":"2018-03-13","enrollment":100,"brief_title":"Abdominal Pressure Assessment Following Open Abdominal Surgery","official_title":"Evaluation of the Abdominal Pressure Modifications in Patients Undergone to Open Abdominal Surgery and Receiving Continuous Positive Airway Pressure","primary_completion_date":"2021-03-05","study_type":"Observational","rec_status":"Recruiting","completion_date":"2021-03-31","last_update":"2020-11-05","description":"During abdominal surgery, the intra abdominal pressure may increase determining lung bibasal atelectasis. The investigators hypothesized that the application of Positive End Expiratory Pressure (PEEP) promptly after extubation through Continuous Positive Airway Pressure (CPAP) would improved gas exchange, especially in those patients with abdominal pressure values close to those applied by CPAP. The investigators have therefore designed this subset study enrolling patients randomized to receive CPAP in the \"Prevention of Respiratory Insufficiency after Surgical Management (PRISM)\" Trial in order to ascertain the abdominal pressure in post-surgical patients (abdominal open surgery procedures) enrolled in PRISM trial. In addition they would evaluate the effects of CPAP on abdominal pressure and consequently on arterial blood gas, and whether there is a correlation between PEEP values, abdominal pressure values and arterial blood gas. One hundred patients included in CPAP group of the PRISM trial will be enrolled in this subset study. The investigators will perform measurements of the abdominal pressure an urinary catheter connected with an intra-abdominal pressure device (Uno-Meter  - Uno-medical) in all patients undergoing on open-surgical procedures after mechanical ventilation withdrawal and extubation, 30 minutes and 4 hours after the application of CPAP.","other_id":"284/2017","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":50,"population":"We will observe the aforementioned physiologic parameters in 100 patients randomized to\r\n        receive CPAP treatment in another international multicenter trial (PRISM trial). Patients\r\n        will be therefore eligible if 50 years old or higher, undergoing major, open,\r\n        intra-peritoneal surgery.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients aged 50 years or over undergoing major, open, intra-peritoneal surgery,\r\n             randomized to receive Continuous Positive Airway Pressure in the \"Prevention of\r\n             Respiratory Insufficiency after Surgical Management (P.R.I.S.M. TRIAL)\"\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Inability or refusal to provide informed consent\r\n\r\n          -  Anticipated requirement for invasive or non-invasive mechanical ventilation for at\r\n             least four hours after surgery as part of routine care\r\n\r\n          -  Pregnancy or obstetric surgery\r\n\r\n          -  Previous enrollment in PRISM trial\r\n\r\n          -  Participation in a clinical trial of a treatment with a similar biological mechanism\r\n             or related primary outcome measure\r\n\r\n          -  Clinician refusal\r\n      ","sponsor":"University Magna Graecia","sponsor_type":"Other","conditions":"Lung Collapse","interventions":[{"intervention_type":"Other","name":"Other: Abdominal pressure assessment","description":"We will perform measurements of the abdominal pressure an urinary catheter connected with an intra-abdominal pressure device (Uno-Meter  - Unomedical) in all patients undergoing on open-surgical procedures after mechanical ventilation withdrawal and extubation, 30 minutes and 4 hours after the application of CPAP."}],"outcomes":[{"outcome_type":"primary","measure":"Abdominal pressure in post-surgical patients (abdominal open surgery procedures)","time_frame":"Within 30 minutes by the end of surgery and mechanical ventilation withdrawn","description":"Assessment of abdominal pressure through a dedicated device connected to the urinary catheter"},{"outcome_type":"secondary","measure":"Abdominal pressure","time_frame":"After 30 minutes from the application of Continuous Positive Airway Pressure","description":"Assessment of abdominal pressure through a dedicated device connected to the urinary catheter"},{"outcome_type":"secondary","measure":"Abdominal pressure","time_frame":"After 4 hours from the application of Continuous Positive Airway Pressure","description":"Assessment of abdominal pressure through a dedicated device connected to the urinary catheter"},{"outcome_type":"secondary","measure":"Arterial blood gases","time_frame":"Within 30 minutes by the end of surgery and mechanical ventilation withdrawn","description":"Sample of arterial blood for gas analysis"},{"outcome_type":"secondary","measure":"Arterial blood gases","time_frame":"After 30 minutes from the application of Continuous Positive Airway Pressure","description":"Sample of arterial blood for gas analysis"},{"outcome_type":"secondary","measure":"Arterial blood gases","time_frame":"After 4 hours from the application of Continuous Positive Airway Pressure","description":"Sample of arterial blood for gas analysis"}]}
{"nct_id":"NCT03301740","start_date":"2018-03-12","phase":"N/A","enrollment":34,"brief_title":"Ultrafiltration Profiling and Outcomes Among Individuals on Maintenance Hemodialysis","official_title":"Ultrafiltration Profiling and Outcomes Among Individuals on Maintenance Hemodialysis","primary_completion_date":"2018-12-15","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-12-18","last_update":"2020-05-15","description":"The rate of fluid removal (ultrafiltration, UF) during hemodialysis (HD) may contribute to cardiovascular morbidity and mortality among individuals receiving maintenance HD. More rapid UF rates are associated with higher morbidity and mortality. Ultrafiltration profiling, the practice of varying UF rates to maximize fluid removal during periods of greatest hydration and plasma oncotic pressures, is one treatment modification that may reduce UF-related harm without necessitating reduction in interdialytic fluid intake or longer HD treatments. To date, UF profiling has not been adequately studied independent of sodium profiling. This study investigates the comparative effect of UF profiling versus non-profiled conventional HD on select cardiovascular and patient-reported outcomes. Participants will complete two phases of UF profiling and two phases of conventional HD and will act as their own controls.","other_id":"17-1057","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Triple","intervention_model_description":"The study is a 4-phase crossover trial in which participants are successively alternated between conventional HD and conventional HD + linear UF profiling across 4 phases with intervening wash-out periods. The study compares conventional HD (the participant's standard HD prescription with no UF profiling) to conventional HD + linear UF profiling. Participants will be randomly allocated to conventional HD or conventional HD + linear UF profiling for phase 1. Participants will undergo 9 treatments during each phase for a total of 18 conventional HD treatments and 18 UF profiled treatments. Participants will undergo 3 wash-out HD treatments between phases.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  UF rate >10 mL/h/kg in >30% of treatments in a 30-day screening period (require 6\r\n             outpatient HD treatments in this period)\r\n\r\n          -  Age 18-85 years\r\n\r\n          -  Ability to converse comfortably in English or Spanish\r\n\r\n          -  Receipt of in-center maintenance HD at Carolina Dialysis clinics in Carrboro or Siler\r\n             City, North Carolina\r\n\r\n          -  90 days on HD\r\n\r\n          -  Free of bloodstream infection during screening period\r\n\r\n          -  Willingness to undergo all study testing\r\n\r\n          -  Evidence of a signed and dated informed consent document\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Systolic BP unable to be measured by arm cuff\r\n\r\n          -  >1 hospitalization during screening period\r\n\r\n          -  Unstable angina per treating nephrologist\r\n\r\n          -  End-stage cirrhosis per treating nephrologist\r\n\r\n          -  New York Heart Association class IV heart failure per treating nephrologist\r\n\r\n          -  Pregnant\r\n\r\n          -  More than 4 times per week HD\r\n\r\n          -  Incarcerated\r\n\r\n          -  Anticipated kidney transplant within 6 months per treating nephrologist\r\n\r\n          -  Non-adherence to HD prescription (>2 unexplained absences during screening period)\r\n\r\n          -  Sodium profiling or UF profiling in standard HD prescription\r\n\r\n          -  Decisionally challenged, unable to provide informed consent\r\n      ","sponsor":"University of North Carolina, Chapel Hill","sponsor_type":"Other","conditions":"End Stage Renal Disease","interventions":[{"intervention_type":"Other","name":"Other: UF profiling during HD","description":"Experimental arm: Linear UF profiling (linearly decreasing UF rate with a UF rate starting at 1.33 times the rate that would be needed at a constant UF rate to achieve the desired post-weight; pre-programmed \"profile 2\" on a Fresenius 2008K machine, the machine used in all participating clinics). Ultrafiltration profiling will be performed using Fresenius 2008K dialysis machines in accordance with manufacturer instructions."},{"intervention_type":"Other","name":"Other: Conventional HD","description":"Control arm: Conventional HD (routine care) is the participant's standard HD prescription without UF profiling."}],"outcomes":[{"outcome_type":"primary","measure":"Occurrence of Intradialytic Hypotension (Intradialytic Hypotension Defined as Nadir Systolic BP <90 mmHg)","time_frame":"Every study hemodialysis treatment, up to 36 treatments per participant over 15 weeks","description":"Intradialytic blood pressure (BP) was measured with an upper extremity cuff in seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Intradialytic hypotension was defined as the presence of a nadir systolic BP <90 mmHg. Odds ratios were estimated using a mixed model (repeated measures logistic regression model)."},{"outcome_type":"primary","measure":"Pre- to Post-hemodialysis Treatment Change in Troponin T Level in ng/mL at Weeks 3, 7, 11, and 15, Using Mixed Model Analysis","time_frame":"Weeks 3, 7, 11, and 15","description":"Troponin T blood samples were collected at 4 study visits. Specifically, at the 7th hemodialysis treatment in each respective study phase (i.e., at week 3, 7, 11, and 15 study visits). Pre- to post-hemodialysis troponin T change was calculated as: post-dialysis troponin T - pre-dialysis troponin T (ng/mL). A lower change value reflects less cardiac strain. Based on the pre-specified protocol, the reported values represent change in troponin T between pre- and post-hemodialysis using mixed model (repeated measures logistic regression) analysis that considered all specified time-points (i.e., weeks 3, 7, 11, and 15)."},{"outcome_type":"primary","measure":"Occurrence of a ≥10% Troponin T Percentage Rise From Pre- to Post-hemodialysis Treatment","time_frame":"Weeks 3, 7, 11, and 15","description":"Troponin T blood samples were collected before and after each participant's 7th hemodialysis treatment of each study phase (4 times during the study). Troponin T percentage change was calculated as [(Post-HD troponin T - pre-HD troponin T) / pre-HD troponin T] x100. Troponin T percentage rise was defined as a troponin T percentage change ≥10%. Odds ratios were estimated using a mixed model (repeated measures logistic regression model)."},{"outcome_type":"primary","measure":"Change From Baseline in Percent Left Ventricular Global Longitudinal Strain (GLS)","time_frame":"Weeks 3 and 7","description":"Left ventricular GLS was measured with transthoracic echocardiography at baseline and at 30 minutes before HD treatment end during the 7th treatment in the first phase of each arm. Left ventricular GLS change was calculated as peak intradialytic stress GLS - baseline GLS (%). A lower change value reflects lesser cardiac strain. Median differences were estimated using Wilcoxon (Mann-Whitney) tests."},{"outcome_type":"secondary","measure":"Nadir Systolic Blood Pressure During Hemodialysis in mmHg","time_frame":"Every study hemodialysis treatment, up to 36 treatments per participant over 15 weeks","description":"Intradialytic BP was measured with an upper extremity cuff in seated position at 15-minute intervals during each hemodialysis treatment per standard dialysis clinic protocols. Nadir systolic BP was defined as the lowest intradialytic systolic BP measurement during each hemodialysis treatment. Lower values reflect greater cardiac strain. Beta-coefficients were estimated using a mixed model (repeated measures linear regression model)."},{"outcome_type":"secondary","measure":"Occurrence of Failed Target Weight Achievement (Failed Target Weight Achievement Defined as a Difference in Prescribed Target Weight and Post-dialysis Weight That is >1 kg or <-1 kg)","time_frame":"Every study hemodialysis treatment, up to 36 treatments per participant over 15 weeks","description":"The treating nephrologist prescribed the target weight per routine clinical care. Post-dialysis weight was measured after each hemodialysis treatment in the standing position, per dialysis clinic protocol. Failed target weight achievement was defined as a difference in prescribed target weight and post-dialysis weight that was >1 kg or <-1 kg. Odds ratios were estimated using a mixed model (repeated measures logistic regression model)."},{"outcome_type":"secondary","measure":"Occurrence of Patient-reported Clinically Important Cramping During Dialysis (Clinically Important Cramping Defined as Moderate, Severe, or Very Severe Cramping)","time_frame":"Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15","description":"Participants' dialysis-related symptoms (e.g. cramping) during the last week were assessed using an investigator-developed 12-question symptom questionnaire administered once weekly throughout the study (6 times per study arm). Each symptom was graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Clinically important cramping was defined as cramping ranked as moderate, severe or very severe. Odds ratios were estimated using a mixed model (repeated measures logistic regression model)."},{"outcome_type":"secondary","measure":"Occurrence of Patient-reported Clinically Important Nausea or Upset Stomach During Dialysis (Clinically Important Nausea or Upset Stomach Defined as Moderate, Severe, or Very Severe Nausea or Upset Stomach)","time_frame":"Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15","description":"Participants' dialysis-related symptoms (e.g. nausea or upset stomach) during the last week were assessed using an investigator-developed 12-question symptom questionnaire administered once weekly throughout the study (6 times per study arm). Each symptom was graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Clinically important nausea/upset stomach was defined as nausea/upset stomach ranked as moderate, severe or very severe. Odds ratios were estimated using a mixed model (repeated measures logistic regression model)."},{"outcome_type":"secondary","measure":"Occurrence of Patient-reported Clinically Important Vomiting or Throwing up During Dialysis (Clinically Important Vomiting or Throwing up Defined as Moderate, Severe, or Very Severe Vomiting or Throwing up)","time_frame":"Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15","description":"Participants' dialysis-related symptoms (e.g. vomiting or throwing up) during the last week were assessed using an investigator-developed 12-question symptom questionnaire administered once weekly throughout the study (6 times per study arm). Each symptom was graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Clinically important vomiting/throwing up was defined as vomiting/throwing up ranked as moderate, severe or very severe. Odds ratios were estimated using a mixed model (repeated measures logistic regression model)."},{"outcome_type":"secondary","measure":"Occurrence of Patient-reported Clinically Important Dizziness or Lightheadedness During Dialysis (Clinically Important Dizziness or Lightheadedness Defined as Moderate, Severe, or Very Severe Dizziness or Lightheadedness)","time_frame":"Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15","description":"Participants' dialysis-related symptoms (e.g. dizziness or lightheadedness) during the last week were assessed using an investigator-developed 12-question symptom questionnaire administered once weekly throughout the study (6 times per study arm). Each symptom was graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Clinically important dizziness/lightheadedness was defined as dizziness/lightheadedness ranked as moderate, severe or very severe. Odds ratios were estimated using a mixed model (repeated measures logistic regression model)."},{"outcome_type":"secondary","measure":"Occurrence of Patient-reported Clinically Important Racing Heart or Heart Palpitations During Dialysis (Clinically Important Racing Heart or Heart Palpitations Defined as Moderate, Severe, or Very Severe Racing Heart or Heart Palpitations)","time_frame":"Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15","description":"Participants' dialysis-related symptoms (e.g. racing heart or heart palpitations) during the last week were assessed using an investigator-developed 12-question symptom questionnaire administered once weekly throughout the study (6 times per study arm). Each symptom was graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Clinically important racing heart/heart palpitations was defined as racing heart/heart palpitations ranked as moderate, severe or very severe. Odds ratios were estimated using a mixed model (repeated measures logistic regression model)."},{"outcome_type":"secondary","measure":"Occurrence of Patient-reported Clinically Important Chest Pain During Dialysis (Clinically Important Chest Pain Defined as Moderate, Severe, or Very Severe Chest Pain)","time_frame":"Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15","description":"Participants' dialysis-related symptoms (e.g. chest pain) during the last week were assessed using an investigator-developed 12-question symptom questionnaire administered once weekly throughout the study (6 times per study arm). Each symptom was graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Clinically important chest pain was defined as chest pain ranked as moderate, severe or very severe. Odds ratios were estimated using a mixed model (repeated measures logistic regression model)."},{"outcome_type":"secondary","measure":"Occurrence of Patient-reported Clinically Important Shortness of Breath During Dialysis (Clinically Important Shortness of Breath Defined as Moderate, Severe, or Very Severe Shortness of Breath)","time_frame":"Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15","description":"Participants' dialysis-related symptoms (e.g. shortness of breath) during the last week were assessed using an investigator-developed 12-question symptom questionnaire administered once weekly throughout the study (6 times per study arm). Each symptom was graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Clinically important shortness of breath was defined as shortness of breath ranked as moderate, severe or very severe. Odds ratios were estimated using a mixed model (repeated measures logistic regression model)."},{"outcome_type":"secondary","measure":"Occurrence of Patient-reported Clinically Important Thirst or Dry Mouth During Dialysis (Clinically Important Thirst or Dry Mouth Defined as Moderate, Severe, or Very Severe Thirst or Dry Mouth)","time_frame":"Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15","description":"Participants' dialysis-related symptoms (e.g. thirst or dry mouth) during the last week were assessed using an investigator-developed 12-question symptom questionnaire administered once weekly throughout the study (6 times per study arm). Each symptom was graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Clinically important thirst/dry mouth was defined as thirst/dry mouth ranked as moderate, severe or very severe. Odds ratios were estimated using a mixed model (repeated measures logistic regression model)."},{"outcome_type":"secondary","measure":"Occurrence of Patient-reported Clinically Important Headache During Dialysis (Clinically Important Headache Defined as Moderate, Severe, or Very Severe Headache)","time_frame":"Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15","description":"Participants' dialysis-related symptoms (e.g. headache) during the last week were assessed using an investigator-developed 12-question symptom questionnaire administered once weekly throughout the study (6 times per study arm). Each symptom was graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Clinically important headache was defined as headache ranked as moderate, severe or very severe. Odds ratios were estimated using a mixed model (repeated measures logistic regression model)."},{"outcome_type":"secondary","measure":"Occurrence of Patient-reported Clinically Important Itching During Dialysis (Clinically Important Itching Defined as Moderate, Severe, or Very Severe Itching)","time_frame":"Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15","description":"Participants' dialysis-related symptoms (e.g. itching) during the last week were assessed using an investigator-developed 12-question symptom questionnaire administered once weekly throughout the study (6 times per study arm). Each symptom was graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Clinically important itching was defined as itching ranked as moderate, severe or very severe. Odds ratios were estimated using a mixed model (repeated measures logistic regression model)."},{"outcome_type":"secondary","measure":"Occurrence of Patient-reported Clinically Important Restless Legs During Dialysis (Clinically Important Restless Legs Defined as Moderate, Severe, or Very Severe Restless Legs)","time_frame":"Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15","description":"Participants' dialysis-related symptoms (e.g. restless legs) during the last week were assessed using an investigator-developed 12-question symptom questionnaire administered once weekly throughout the study (6 times per study arm). Each symptom was graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Clinically important restless legs was defined as restless legs ranked as moderate, severe or very severe. Odds ratios were estimated using a mixed model (repeated measures logistic regression model)."},{"outcome_type":"secondary","measure":"Occurrence of Patient-reported Clinically Important Tingling or Feeling of Pins and Needles During Dialysis (Clinically Important Tingling or Feeling of Pins and Needles Defined as Moderate, Severe, or Very Severe Tingling or Feeling of Pins and Needles)","time_frame":"Weeks 1, 2, 3, 5, 6, 7, 9, 10, 11, 13, 14, 15","description":"Participants' dialysis-related symptoms (e.g. tingling or feeling of pins and needles during the last week were assessed using an investigator-developed 12-question symptom questionnaire administered once weekly throughout the study (6 times per study arm). Each symptom was graded using a 5-point symptom severity Likert scale (response options: none, mild, moderate, severe, very severe). Clinically important tingling/feeling of pins and needles was defined as tingling/feeling of pins and needles ranked as moderate, severe or very severe. Odds ratios were estimated using a mixed model (repeated measures logistic regression model)."}]}
{"nct_id":"NCT04025619","start_date":"2018-03-12","phase":"N/A","enrollment":86,"brief_title":"Development of Novel Adhesive Sports Tape Modular to Facilitate Use of Discomfort","official_title":"Development of Novel Adhesive Sports Tape Modular to Facilitate Use of Discomfort","primary_completion_date":"2019-05-20","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-06-20","last_update":"2020-09-09","description":"Special metals (e.g. Germanium, Titanium, and  element) can be used to produce far-infrared radiation. The applications of these metals in promoting blood circulation are worth investigating. This clinical trial recruited subjects for using tape made up of Ge, Ti, and  element developed by Green Energy Nano Technology Co., Ltd. We assumed that the experimental tape can improve the participants' peripheral blood circulation and their quality of life. In this clinical trial, the clinical efficacy and safety of the test products were assessed using physical examination and questionnaires.","other_id":"GreenE2017","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"2 groups of participant, one of the group took the questionnaire then received the intervention for seven days, then took the same questionnaire again.\r\nThe other group took the physical examination and received the intervention immediately, then took the physical examination again when the intervention is on the treating area.","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Cardiovascular disease (deep Vein Thrombosis or Chronic venous insufficiency)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Vulnerable populations\r\n\r\n          -  wound at lower limb which can not take the intervention\r\n\r\n          -  one can not make express consent clearly\r\n\r\n          -  dyslexia\r\n\r\n          -  who need physical assistance during ambulation\r\n\r\n          -  nonfunctional ambulator\r\n      ","sponsor":"National Defense Medical Center, Taiwan","sponsor_type":"Other","conditions":"Cardiovascular Disease","interventions":[{"intervention_type":"Device","name":"Device: tape","description":"Sports tape"}],"outcomes":[{"outcome_type":"primary","measure":"Ankle-Brachial Pressure Index","time_frame":"1 day","description":"Detect the pressure difference in percentage between brachial pressure and ankle pressure by the pulse volume record and ultrasound device."},{"outcome_type":"primary","measure":"MVO/SVC","time_frame":"1 day","description":"The ratio of maximum venous outflow (MVO) to the segmental venous capacitance (SVC)"},{"outcome_type":"primary","measure":"Visual Analog Scale (VAS) Pain","time_frame":"1 day","description":"VAS is measurement instrument for describing pain severity or intensity. The pain scale is range from 0 to 10, representing \"no hurt\" to \"hurt worst\", respectively."},{"outcome_type":"secondary","measure":"Kidney Disease Quality of Life","time_frame":"Day 0 (before intervention) and Day 7 (after using the intervention for 7 days)","description":"Questionnaire to assess generic and kidney-disease targeted aspects of quality of life"}]}
{"nct_id":"NCT03905005","start_date":"2018-03-12","enrollment":20,"brief_title":"Jaw Reconstruction With Printed Titanium and Free Tissue Transfer","official_title":"Jaw Reconstruction With Printed Titanium and Free Tissue Transfer","primary_completion_date":"2020-09-30","study_type":"Observational","rec_status":"Unknown status","completion_date":"2020-09-30","last_update":"2019-04-05","description":"JaW PrinT is a prospective observational cohort study evaluating the effectiveness of two different techniques of mandibular reconstruction.","other_id":"241919","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"Patients from the study site region requiring free-flap reconstruction of the mandible\r\n        (e.g. for tumour or osteoradionecrosis):","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age over 18 years\r\n\r\n          -  Able to provide informed consent\r\n\r\n          -  A planned fibular free-flap reconstruction of the mandible\r\n\r\n          -  Planned post operative surveillance CT scan 6 months following surgery\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Clinically unfit or inappropriate (based upon prognosis/life expectancy) for\r\n             reconstruction using free tissue transfer techniques\r\n\r\n          -  Patients with planned surgical defects involving formal reconstruction of the condyle.\r\n             (Clinical use of printed plates for condylar reconstructions would in effect be\r\n             'off-licence' and non-standard treatment which is beyond the remit of an observational\r\n             research study).\r\n\r\n          -  Flap failure within the study follow-up period, as this would require early removal of\r\n             the flap and therefore preclude collection of follow-up outcome data. However, any\r\n             flap failures (and associated clinical complications/events) will be recorded and\r\n             reported.\r\n      ","sponsor":"University of South Wales","sponsor_type":"Other","conditions":"Neoplasm, Oral|Osteoradionecrosis of Jaw|Mandibular Diseases|Jaw Cancer|Jaw Diseases|Surgery","interventions":[{"intervention_type":"Procedure","name":"Procedure: Mandibular reconstruction with free tissue transfer.","description":"Mandibular reconstruction with free tissue transfer (free-flap bony reconstruction) requires the use of a titanium plate to secure bony segments until bony healing is complete. Plates are made of titanium but can be customised to the anatomical shape of the mandible by two different techniques: flexing (bending) of the plate before surgery, or printing of the plate from titanium alloy powder bed fusion techniques (additive manufacturing, such as selective laser melting)."}],"outcomes":[{"outcome_type":"primary","measure":"Dimensional accuracy","time_frame":"6 months","description":"Dimensional accuracy of the bony reconstruction, as demonstrated by comparing 6 months postoperative CT scan DICOM data with a presurgical digital surgical plan."},{"outcome_type":"secondary","measure":"Duration of surgery","time_frame":"1 day (day of surgery)","description":"The impact of surgical technique (pathway A or B) on the duration of insetting the bony flap into the mandibular continuity defect."},{"outcome_type":"secondary","measure":"Operator's rating of usability/confidence/satisfaction with technique","time_frame":"1 day (day of surgery)","description":"Using 5 point Likert scale ratings of ease of flap preparation, ease of locating the reconstruction plate on the fibula, confidence with technique, ease of mandibular reconstruction, ease of locating the reconstruction plate on the mandible, bony apposition of fibula-fibula and fibula-mandible osteotomies as planned, satisfaction with morphology of reconstructed mandible, confidence with technique overall (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree)."},{"outcome_type":"secondary","measure":"Need to make adjustments to reconstructive surgical plan intraoperatively","time_frame":"1 day (day of surgery)","description":"List of all required adjustments to the planned reconstructive surgical procedure (e.g. trimming of osteotomies etc.) are recorded."},{"outcome_type":"secondary","measure":"Complications","time_frame":"1 year postoperatively","description":"Incidence of intra/peri/post-operative complications are recorded (e.g. infection, plate exposure, prolonged hospital stay, non-union etc.)"},{"outcome_type":"secondary","measure":"Qualitative evaluation of dental occlusal relationship and feasibility of dental implant rehabilitation","time_frame":"1 year postoperatively","description":"Qualitative Evaluation of changes in dental occlusion by evaluating dental plaster of Paris models (presence or absence of \"malocclusion\" pre and post-operatively) PLUS assessment/rating of feasibility of dental implant rehabilitation in relation to actual bony reconstruction using a 5 point likert scale (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree)"},{"outcome_type":"secondary","measure":"Patient reported quality of life relating to appearance","time_frame":"Baseline, 6 weeks, 6 months, 1 year postoperatively","description":"Subjective scoring of patient's own perceptions of their quality of life relating to their appearance using the Derriford Appearance Scale"},{"outcome_type":"secondary","measure":"Patient perceived quality of life relating to mood","time_frame":"Baseline, 6 weeks, 6 months, 1 year postoperatively","description":"University of Washington v4.0 questionnaire score."},{"outcome_type":"secondary","measure":"Financial implications of surgical technique","time_frame":"Separately for duration of inpatient hospital stay (typically 2 weeks) and for the total 1 year study follow-up period (from identification of participant to completion of patient's participation).","description":"Evaluation of cost differences (if any) between patient groups"},{"outcome_type":"secondary","measure":"Patient perceived quality of life relating to oral function","time_frame":"Baseline, 6 weeks, 6 months, 1 year postoperatively","description":"Liverpool oral rehabilitation questionnaire scores."},{"outcome_type":"secondary","measure":"objective quantitative evaluation of facial symmetry","time_frame":"Baseline, 6 weeks, 6 months, 1 year postoperatively","description":"stereophotogrammetry to assess facial symmetry."}]}
{"nct_id":"NCT03460808","start_date":"2018-03-10","phase":"Phase 1/Phase 2","enrollment":200,"brief_title":"The Combination of Atorvastatin, Acetylcysteine and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia","official_title":"The Combination of Atorvastatin, Acetylcysteine and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia","primary_completion_date":"2020-01-01","study_type":"Interventional","rec_status":"Not yet recruiting","completion_date":"2023-01-01","last_update":"2018-03-09","description":"Single-arm, open-lable, multicentre study to compare the efficacy and safety of atorvastatin, acetylcysteine plus danazol with danazol monotherapy in patients with corticosteroidresistant/relapsed ITP.","other_id":"Z171100001017084","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  ITP confirmed by excluding other supervened causes of thrombocytopenia;\r\n\r\n          -  Platelet count of less than 3010^9/L at enrollment;\r\n\r\n          -  Patients who did not achieve a sustained response to treatment with full dose\r\n             corticosteroids for a minimum duration of 4 weeks or who relapsed during\r\n             steroid-tapering or after its discontinuation;\r\n\r\n          -  ECOG<2.\r\n\r\n          -  EPCs in bone marrow less than 0.02%\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori\r\n             infection or patients with systemic lupus erythematosus)\r\n\r\n          -  congestive heart failure\r\n\r\n          -  severe arrhythmia\r\n\r\n          -  nursing or pregnant women\r\n\r\n          -  aspartate aminotransferase and alanine transaminase levels  3 the upper limit of the\r\n             normal threshold criteria\r\n\r\n          -  creatinine or serum bilirubin levels each 1.5 times or more than the normal range\r\n\r\n          -  active or previous malignancy\r\n\r\n          -  Unable to do blood routine test for the sake of time, distance, economic issues or\r\n             other reasons.\r\n      ","sponsor":"Peking University People's Hospital","sponsor_type":"Other","conditions":"Immune Thrombocytopenia","interventions":[{"intervention_type":"Drug","name":"Drug: atorvastatin","description":"Atorvastatin was used in combination with acetylcysteine and danazol."},{"intervention_type":"Drug","name":"Drug: Acetylcysteine","description":"Acetylcysteine was used in combination with atorvastatin and danazol."},{"intervention_type":"Drug","name":"Drug: Danazol","description":"Danazol was used in combination with atorvastatin and acetylcysteine or as the monotherapy"}],"outcomes":[{"outcome_type":"primary","measure":"the sustained platelet response at the 6-month follow-up","time_frame":"From the start of study treatment (Day 1) up to the end of Month 6","description":"The number of participants (responders) with platelet count >=30x10^9/L and at least a 2-fold increase in the baseline count (PR) or a platelet count >=100x10^9/L (CR) and the absence of bleeding, without rescue medication at 6-month follow-up."},{"outcome_type":"secondary","measure":"overall response","time_frame":"From the start of study treatment (Day 1) up to the end of Month 6","description":"The number of participants with platelet count >=30×10^9/L at least once and at least a doubling of the baseline platelet count without the administration of any other platelet increasing therapy."},{"outcome_type":"secondary","measure":"time to response","time_frame":"From the start of study treatment (Day 1) up to the end of Year 2","description":"Time to response was defined as the time from starting treatment to the time to achieve the response."},{"outcome_type":"secondary","measure":"duration of response","time_frame":"From the start of study treatment (Day 1) up to the end of Year 2","description":"Duration of response was measured from the achievement of response to the loss of response."},{"outcome_type":"secondary","measure":"incidence of treatment-emergent adverse events","time_frame":"From the start of study treatment (Day 1) up to the end of Year 2","description":"All patients were assessed for treatment-emergent adverse events every week during the first 8 weeks of treatment, and at 2-week intervals thereafter. Adverse events were scaled according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0"}]}
{"nct_id":"NCT03762096","start_date":"2018-03-06","phase":"N/A","enrollment":40,"brief_title":"Short Interval Resveratrol Trial in Cardiovascular Surgery","official_title":"Short Interval Resveratrol Trial in Cardiovascular Surgery","primary_completion_date":"2021-04-16","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-12-31","last_update":"2021-09-22","description":"Major Problem People with diabetes have an increased risk of heart disease, heart failure, and death from a cardiovascular cause. Diabetes prevents efficient metabolism of fuel, causes inflammation and vascular disease that blocks normal blood flow, and inhibits the function of the heart after injury. These changes make diabetics more susceptible to heart attacks and heart failure. Resveratrol is found in grapes and red wine and has been shown to have beneficial effects in diabetic patients. In previous studies the investigators have shown that resveratrol can improve heart metabolism and function in pigs with diabetes and chronic lack of blood flow to the heart. Questions The investigators believe resveratrol will help reverse the negative effects of diabetes on the heart. The questions are: 1.How does the molecular machinery in the hearts of patients with diabetes differ from patients without diabetes? 2.Will resveratrol have an effect on heart metabolism, intracellular signaling, inflammation and blood vessel function? 3.Will resveratrol improve the number and function of cardiac stem cells, cells involved in heart repair? The investigators have been safely collecting tissue from the hearts of patients undergoing heart surgery. Preliminary studies show the investigators can isolate and study cells. The investigators have collected and assessed the function of endothelial cells, a measure of vascular health and can measure the level of endothelial injury and have studied the make-up of caveolae, structures on the cell membrane that are important for cell signaling and are negatively impacted by diabetes. This study is a unique collaboration among cardiologists, cardiac surgeons, and basic scientists.","other_id":"1095584","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adult patients (age >18 years)\r\n\r\n          -  Type 2 diabetes (controlled by either oral agents or insulin)\r\n\r\n          -  Coronary artery disease referred for elective CABG with CPB\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Known decompensated congestive heart failure or systolic heart failure with an\r\n             ejection fraction < 45% at the time of evaluation\r\n\r\n          -  Liver Function Tests (LFT) greater than 2 times normal\r\n\r\n          -  Renal dysfunction (GFR less than 60 mL/min)\r\n\r\n          -  Abnormal coagulation profile (PT/PTT and INR)\r\n\r\n          -  Alcohol consumption more than 3 grams (equivalent to 2.5 glasses of wine) daily\r\n\r\n          -  Positive HIV, Hepatitis B or C testing\r\n\r\n          -  Severe ventricular arrhythmias\r\n\r\n          -  Significant hypotension (SBP < 90 mmHg) at the time of enrollment\r\n\r\n          -  Patients who are pregnant\r\n\r\n          -  Known malignancy other than non-melanoma skin cancers\r\n\r\n          -  Expected survival less than one year.\r\n\r\n          -  Allergy or intolerance to the ingredients of the supplement or the placebo\r\n\r\n          -  Inability to comply with the study requirements.\r\n      ","sponsor":"MaineHealth","sponsor_type":"Other","conditions":"Coronary Artery Disease|Diabetes Mellitus, Type 2","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Trans-resveratrol","description":"1 gram, twice a day by mouth Transmax (Biotivia)"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Placebo","description":"Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"Change in endothelial function","time_frame":"6 weeks","description":"Serum levels of nitric oxide (ELISA assay)"},{"outcome_type":"primary","measure":"Change in endothelial function","time_frame":"14 days","description":"Nitric oxide synthase levels in heart tissue (Western blot assay)"},{"outcome_type":"secondary","measure":"Effects of resveratrol on caveolar function","time_frame":"14 days","description":"Lipidomic changes in cell membranes (Mass spectrometry)"},{"outcome_type":"secondary","measure":"Effects of resveratrol on molecular signaling","time_frame":"14 days","description":"Serum and tissue levels of pathways associated with glucose metabolism (Western blot assay)"}]}
{"nct_id":"NCT04095897","start_date":"2018-03-06","enrollment":288,"brief_title":"Does Pecs II Block Reduce the Incidence of Post Mastectomy Pain Syndrome (PMPS)? A Cross Sectional Study","official_title":"Does Pecs II Block Reduce the Incidence of Post Mastectomy Pain Syndrome (PMPS)? A Cross Sectional Study","primary_completion_date":"2018-12-28","study_type":"Observational [Patient Registry]","rec_status":"Completed","completion_date":"2019-02-20","last_update":"2019-09-19","description":"Post mastectomy pain syndrome (PMPS) is a chronic pain condition that develops after breast cancer surgery. The objective of this study was to determine if Pecs II block administered prior to general anesthesia (GA) reduced the incidence of PMPS after mastectomy and axillary clearance (MAC) when compared with conventional analgesic therapy.","other_id":"FF-2018-084","observational_model":"Cohort","time_perspective":"Cross-Sectional","sampling_method":"Probability Sample","gender":"Female","population":"patient underwent unilateral mastectomy for breast carcinoma","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  patient underwent unilateral mastectomy for breast carcinoma\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  past history of chronic pain and on regular analgesics, chemotherapy or radiotherapy\r\n             before surgery, surgical complications (such as infection or wound breakdown) or\r\n             cancer recurrence, history of psychiatric illness, inability to be contacted,\r\n             inability or unwillingness to participate in the study\r\n      ","sponsor":"Universiti Kebangsaan Malaysia Medical Centre","sponsor_type":"Other","conditions":"Chronic Pain","interventions":[{"intervention_type":"Procedure","name":"Procedure: Pecs II Block","description":"Peripheral nerve block - Regional anesthesia : Pectoral Nerve block type 2"}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of PMPS","time_frame":"2 years","description":"Incidence of Post mastectomy pain syndrome (PMPS)"},{"outcome_type":"secondary","measure":"Severity of PMPS","time_frame":"2 years","description":"Severity of Post mastectomy pain syndrome (PMPS)"}]}
{"nct_id":"NCT03637829","start_date":"2018-03-05","phase":"N/A","enrollment":26,"brief_title":"Effect of Morning Snack on Cognitive Performance in Adults","official_title":"Effect of Mid-morning Snacks on Cognitive Performance, Satiety, Food Intake, and Glycemic Response in Normal Weight Adults","primary_completion_date":"2018-09-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-09-01","last_update":"2019-05-21","description":"To characterize the effects of three chocolate snacks on cognitive performance, subjective appetite, food intake control, and glycemic response in normal weight adults.","other_id":"Ryerson-REB-2017-339","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Other","masking_description":"Double","intervention_model_description":"A random and within subject, repeated measures experiment to study the effect of chocolate on cognitive performance, subjective appetite, food intake, and glycemic response in normal weight adults.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":35,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  be between 18 and 35 years of age\r\n\r\n          -  be healthy and have a have body mass index (BMI) between 18.5 and 24.9\r\n\r\n          -  not be taking any medications, not smoking, and\r\n\r\n          -  not have allergies to chocolate, dairy or gluten\r\n\r\n          -  be tested during the early follicular phase of their menstrual cycle for women\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  anyone with food sensitivities or allergies to chocolate, dairy or gluten,\r\n\r\n          -  smokers\r\n\r\n          -  diabetic or overweight/obese individuals.\r\n\r\n          -  Restrained eating habits, defined as scoring greater than 11 points on the eating\r\n             habits questionnaire\r\n      ","sponsor":"Ryerson University","sponsor_type":"Other","conditions":"Nutrition|Cognitive Change|Food Intake Control|Satiety","interventions":[{"intervention_type":"Other","name":"Other: Control","description":"Water"},{"intervention_type":"Other","name":"Other: White chocolate","description":"Experimental snack treatment"},{"intervention_type":"Other","name":"Other: Dark chocolate 1","description":"Experimental snack treatment"},{"intervention_type":"Other","name":"Other: Dark chocolate 2","description":"Experimental snack treatment"}],"outcomes":[{"outcome_type":"primary","measure":"Verbal declarative memory","time_frame":"At 15 minutes","description":"One of six word lists composed of 15 words will be audio presented and participants will be asked to write them down. The word list will be presented 3 times and the participant will immediately write down words after each time the word list is presented. This test will take 5 minutes"},{"outcome_type":"primary","measure":"Change from baseline spatial memory","time_frame":"At Baseline, 15, 45, and 75 minutes","description":"Assessed using a spatial pattern recognition test on the Membrain Application. There will be a grid of 9 boxes with circles randomly located inside each box. Participants will be asked to remember where circles are located in each box. This test is done 6 times at each time-point, with each test having different random locations of circles. Each test will take 20 seconds."},{"outcome_type":"primary","measure":"Change in verbal declarative memory from the 15 minute time-point","time_frame":"At 45 and 75 minutes","description":"Participants will be asked to recall and write down all the words from the word list presented at the 15 minute time-point. This test will take 2 minutes."},{"outcome_type":"primary","measure":"Change from baseline executive function","time_frame":"At Baseline, 15, 45, and 75 minutes","description":"Will be assessed the Stroop task via the Membrain application. Participants will be presented with a list of words presented in colors that match the word (congruent, the word 'red' presented in red) or colors that do not match the word (incongruent, the word 'red' presented in blue). Participants will be asked to identify the color of the word, not the word itself. The task is scored for the number of correct and incorrect colors identified, as well as total time to completion. This test will be at each time-point and will take 1 minute to complete."},{"outcome_type":"primary","measure":"Change from baseline working memory and executive function","time_frame":"At Baseline, 15, 45, and 75 minutes","description":"A random 3 digit number will appear on the screen of the Membrain Application and the participant will have to continually subtract 3 from this number. At each time-point, participants will also complete the same test, except will subtract 7 continuously. This is a 2 minute test."},{"outcome_type":"primary","measure":"Change from baseline attention and reaction time","time_frame":"At Baseline, 15, 45, and 75 minutes","description":"Using the Membrain Application, Aa continuous string of single digit numbers appear on the screen, one at a time (each appearing for about one second). After seeing three consecutive ascending odd numbers, participants click the 'odd' button. When they see three consecutive, ascending even numbers, they click the 'even' button. When they see the number \"1\", they click the 'tertiary' button. This test is 5 minutes in length."},{"outcome_type":"secondary","measure":"Change from baseline subjective average emotions","time_frame":"At Baseline, 15, 30, 45, 60, 75 and 90 minutes","description":"Measured using 100 point visual analogue scales. Participants mark on this line to describe their feelings."},{"outcome_type":"secondary","measure":"Change from baseline global vigor","time_frame":"At Baseline, 15, 30, 45, 60, 75 and 90 minutes","description":"Measured using 100 point visual analogue scales. Participants mark on this line to describe their feelings."},{"outcome_type":"secondary","measure":"Change from baseline subjective average appetite","time_frame":"At Baseline, 15, 30, 45, 60, 75 and 90 minutes","description":"Measured using 100 point visual analogue scales. Participants mark on this line to describe their feelings."},{"outcome_type":"secondary","measure":"Change from baseline blood glucose concentration","time_frame":"At Baseline, 15, 30, 45, 60, 75 and 90 minutes","description":"Blood glucose concentration (mmol/L) will be measured in whole blood using YSI 2300 STAT PLUS (YSI Incorporated, Yellow Springs, OH)"},{"outcome_type":"secondary","measure":"Food intake","time_frame":"At 90 minutes","description":"After other measures at the 90 minute time-point, participants will have lunch and food intake will be determined by weighing the meal before and after serving. The net weight of the test meal will be converted to kilocalories"}]}
{"nct_id":"NCT03457519","start_date":"2018-03-05","phase":"N/A","enrollment":141,"brief_title":"Children's Automated Respiration Monitor (ChARM) for Child Pneumonia Diagnosis by Community Health Workers in Mali","official_title":"Children's Automated Respiration Monitor (ChARM) for Child Pneumonia Diagnosis by Community Health Workers in Mali: Innovating ChARM's Role in Supervision, Training and Diagnosis, a Cluster Randomized Control Trial","primary_completion_date":"2019-01-21","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-01-21","last_update":"2019-06-25","description":"The primary objective of this study is to estimate the impact of a self-monitoring tool (ChARM), used as a teaching/monitoring device, on the CHWs respiratory rate counting accuracy when assessing children under the age of 5 years with suspected pneumonia symptoms.","other_id":"R-ST-POC-1707-07682","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","intervention_model_description":"Intervention Group A - Community Health Workers (CHWs) (Basic training in CHW curriculum, ChARM training and 8-month application of the ChARM device, self-monitoring, direct observation and review of CHW routine monthly reports and drug supply sheets): 8 months, March- November 2018.\r\nIntervention Group B - Community Health Workers (Basic training in CHW curriculum, ChARM training and 4-month application of the ChARM device, self-monitoring, direct observation and review of CHW routine monthly reports and drug supply sheets): March- November 2018.\r\nControl Group C - Community Health Workers (Basic training in CHW curriculum, direct observation and CHW routine monthly reports and drug supply sheets): 8 months, March- November 2018.","sampling_method":"","gender":"All","minimum_age":15,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -   Be currently providing iCCM services on a full-time basis to the populations they\r\n             are serving.\r\n\r\n               -  Have completed the Malian Ministry of Health basic community health care worker\r\n                  training provided as part of the 2016-2020 Strengthening Maternal, Newborn and\r\n                  Child Health project.\r\n\r\n               -  Are using a device (a respiratory timer) as part of their basic MoH training\r\n                  package, or have a cell phone to use to count the respiratory rates of children\r\n                  under five with suspected symptoms of pneumonia.\r\n\r\n               -  Be willing to participate in a trial to study the impact of using ChARM as a\r\n                  self-monitoring tool to improve the capacity to detect pneumonia.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -   CHWs in conflict ridden geographical areas within the district or not, providing\r\n             consistent services on a full-time basis to the populations they are serving.\r\n\r\n               -  CHWs not willing to participate in the trial.\r\n\r\n               -  CHWs who do not have a device (watch, respiratory timer or cell phone) to support\r\n                  measurement of respiratory rates and who are not routinely counting respiratory\r\n                  rate to diagnose suspected pneumonia.\r\n\r\n               -  CHWs who did not complete the MoH basic training for CHWs provided through the\r\n                  2016-2020 Strengthening Maternal, Newborn and Child Health program\r\n      ","sponsor":"Diego Bassani","sponsor_type":"Other","conditions":"Acute Respiratory Infection","interventions":[{"intervention_type":"Device","name":"Device: Children's Automated Respiration Monitor (ChARM)","description":"The Philips CHARM (children's automatic respiratory monitor) is specifically designed to detect pneumonia in low resource areas. The lightweight measuring device sits on a child's or infant's chest, secured by a strap and measures respiration rate (fast breathing) through an ingenious algorithm. In this study ChARM will be used as a self monitoring and teaching aide by the CHWS."}],"outcomes":[{"outcome_type":"primary","measure":"Acute Respiratory Illness (ARI) Case fatality rate","time_frame":"8 months","description":"Acute Respiratory Illness (ARI) Case fatality rate defined as number of deaths from respiratory infections among children diagnosed with respiratory infections"},{"outcome_type":"secondary","measure":"Respiratory rate counting accuracy","time_frame":"8 months","description":"Respiratory rate is defined as the number of breaths taken per minute"},{"outcome_type":"secondary","measure":"Proportion of pneumonia cases detected and treated by CHWs","time_frame":"8 months","description":"Proportion of pneumonia cases detected by the CHWs that are treated by CHWs"},{"outcome_type":"secondary","measure":"Proportion of suspected severe pneumonia cases referred by CHWs to the CSCom","time_frame":"8 months","description":"Proportion of all suspected severe pneumonia cases identified by the CHWs (based on presence of fever and increased respiratory rates for age) referred by CHWs to the CSCom"},{"outcome_type":"secondary","measure":"Proportion of suspected pneumonia cases in the community who sought care from a CHW","time_frame":"8 months","description":"Proportion of self-referenced pneumonia cases in the community (via household survey) who report seeking care from a CHW"},{"outcome_type":"secondary","measure":"Accuracy in drug management and procurement requests","time_frame":"8 months","description":"Percent of CHW with no stock-outs in the last 4 months"}]}
{"nct_id":"NCT03438305","start_date":"2018-03-01","enrollment":48,"brief_title":"Role of Gastric Ultrasound in Preoperative Assessment of Gastric Volume in Diabetic Patients.","official_title":"Role of Gastric Ultrasound in Preoperative Assessment of Gastric Volume in Longstanding Diabetic Patients. (Prospective Observational Study).","primary_completion_date":"2018-06-01","study_type":"Observational [Patient Registry]","rec_status":"Unknown status","completion_date":"2018-06-01","last_update":"2018-02-19","description":"Background :An important risk factor for aspiration is gastric volume, determined in large part by gastric emptying. Unfortunately, measuring gastric volume over time is not easy, and scintigraphy has remained the gold standard technique for many years. Ultrasound has progressively emerged as a useful substitute due to its reduced cost and ease of performance Objectives:Assess whether ultrasonographic measurement of antral cross sectional area (CSA) can be used reliably for the diagnosis of risk stomach which defined by a gastric content volume at risk of clinical consequences for pulmonary aspiration (i.e., presence of solid particles and/or gastric fluid volume >1.5 ml/kg) during the preoperative period in longstanding diabetic patients. Study population : - -Longstanding diabetic patients (group D) - -Non diabetic patients (group N) Study Design : Prospective observational study This study will be conducted at Kasr alainy Hospital; Faculty of Medicine, Cairo University.Patients scheduled for elective operations need General Anesthesia (GA) with endotracheal intubation in theatre of general surgery Preoperative ultrasound to assess gastric residual volume then general anesthesia induction will be Modified Rapid-sequence Induction as follow; Group (D)/(N) : propofol 2-3mg/kg and fentanyl 1 g/Kg followed by Rocuronium 0.6-1.2 mg/kg. Suction of Gastric Contents by Nasogastric tube (18 french) will be inserted First set of analysis will be comparing preoperative US findings in 2 groups. Second set of analysis will be finding correlation between US findings and suction volume in two groups. Outcome parameters: To assess the residual gastric volume in longstanding diabetic patients compared to non diabetic patients. Sample Size ; was calculated as 48 patients (24) in each group.","other_id":"N-74-2017","observational_model":"Other","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":40,"maximum_age":60,"population":"Diabetic patients with long standing diabetis ( more than 6 years) so , it may affect\r\n        gastric nerve supply.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Ages from 40 to 60 years old.\r\n\r\n          -  American Society of Anesthiologist (ASA) II.\r\n\r\n          -  Diabetic patients with longstanding duration(more than 6 years).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Age <40,>60 years .\r\n\r\n          -  Pregnant female\r\n\r\n          -  Obese patients (BMI 40)\r\n\r\n          -  Patients with Gastric Intestinal Tract (GIT) diseases affect gastric emptying.\r\n\r\n          -  Diabetic patients less than 6 years.\r\n      ","sponsor":"Cairo University","sponsor_type":"Other","conditions":"Gastroparesis","interventions":[{"intervention_type":"Other","name":"Other: sonar assessment of gastric volume in Diabetic patients","description":"assessment of gastric volume in Diabetic Patients"},{"intervention_type":"Other","name":"Other: sonar assessment of gastric volume in Non Diabetic patients","description":"assessment of gastric volume in Non- Diabetic Patients"}],"outcomes":[{"outcome_type":"primary","measure":"assessment of residual gastric volume in longstanding diabetic patients","time_frame":"intra-operative","description":"To assess the residual gastric volume in longstanding diabetic patients compared to non diabetic patients"},{"outcome_type":"secondary","measure":"correlation between preoperative gastric US findings and fasting hours in both groups","time_frame":"intraoperative","description":"To correlate between preoperative gastric US findings and fasting hours in both groups to confirm delayed gastric emptying in diabetic group."}]}
{"nct_id":"NCT04196075","start_date":"2018-03-01","phase":"Phase 3","enrollment":30,"brief_title":"The Effect of Andrographis Paniculata (AP) on Palliative Management of Advanced Esophageal Cancer","official_title":"The Effect of Andrographis Paniculata (AP) on Palliative Management of Advanced Esophageal Cancer","primary_completion_date":"2021-02-28","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-06-30","last_update":"2021-02-02","description":"This is a prospective cohort study on the effect of Andrographis Paniculata (AP) on palliative management of patients with advanced or metastatic esophageal cancer. A total of 30 patients with locally advanced or metastatic squamous esophageal cancer will be recruited for the trial.","other_id":"CRE-2017.616","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Aged over 18\r\n\r\n          2. Locally advanced esophageal cancer with invasion or adherent to surrounding organs\r\n             including trachea, recurrent laryngeal nerves and descending aorta;\r\n\r\n          3. Presence of distant metastasis;\r\n\r\n          4. Extensive lymph node metastasis to beyond surgical therapy\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients who cannot receive palliative stenting for dysphagia or under other\r\n             conventional treatment including chemotherapy or chemoradiotherapy\r\n\r\n          2. Patients who are not willing to receive Chinese herbal medicines\r\n\r\n          3. Patients who do not consent for the study\r\n      ","sponsor":"Chinese University of Hong Kong","sponsor_type":"Other","conditions":"Squamous Cell Carcinoma of Esophagus","interventions":[{"intervention_type":"Drug","name":"Drug: Andrographis Paniculata","description":"AP as palliative treatment"}],"outcomes":[{"outcome_type":"primary","measure":"Symptomatic relief and quality of life after AP","time_frame":"4 months","description":"Symptomatic relief of Dysphagia and quality of life after treatment Dysphagia measured by Dysphagia score Quality of Life measured by EORTC-QLQ-C30"},{"outcome_type":"secondary","measure":"Difficulty to swallow","time_frame":"4 months","description":"Difficulty to swallow by dysphagia grade 0 = able to eat normal diet / no dysphagia.\r\n= able to swallow some solid foods\r\n= able to swallow only semi solid foods\r\n= able to swallow liquids only\r\n= unable to swallow anything / total dysphagia"},{"outcome_type":"secondary","measure":"Survival","time_frame":"up to 36 months","description":"Median Survival"},{"outcome_type":"secondary","measure":"Adverse events","time_frame":"up to 36 months","description":"Rate of adverse events"},{"outcome_type":"secondary","measure":"AP side effects","time_frame":"4 months","description":"Side effects related to AP including\r\nGastrointestinal upset\r\nNausea and Vomiting\r\nAllergy\r\nDiarrhoea\r\nAbdominal pain\r\nDizziness"}]}
{"nct_id":"NCT03198364","start_date":"2018-03-01","phase":"N/A","enrollment":78,"brief_title":"Development of a Mobile Heath Augmented Brief Suicide Prevention Intervention for People With SMI","official_title":"Development of a Mobile Heath Augmented Brief Suicide Prevention Intervention for People With SMI Accessing Community Care","primary_completion_date":"2020-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2021-06-30","last_update":"2021-09-05","description":"Schizophrenia and bipolar disorder are associated with high risk for suicide, yet there are few brief interventions that directly target suicide prevention in this large population. The goal of this intervention development study is to evaluate the feasibility, acceptability, and preliminary effectiveness of a brief intervention called SafeTy and Recovery Therapy (START) that is augmented with content delivered on mobile devices outside of the clinic setting. The intervention will evaluated in a community urgent care center context as people initiate outpatient care, and, if effective, could be deployed in a wide network of such centers.","other_id":"1R34MH113613-01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        All subjects are recruited from San Diego area \"walk-in\" behavioral health evaluation\r\n        services and must be referred by a triage clinician at such facilities. The study is unable\r\n        to accept referrals from other sources. In addition, the following criteria apply:\r\n\r\n        Inclusion Criteria:\r\n\r\n          1. Subjects must have present suicidal ideation CSSR-S> 2 (\"Active thoughts of killing\r\n             oneself\") in past 1 month and/or a suicide attempt in the prior 3 months as identified\r\n             by the Columbia Suicide Severity Rating Scale\r\n\r\n          2. Diagnosis of DSM-V bipolar disorder, schizophrenia, or schizoaffective disorder as\r\n             identified by the MINI International Neuropsychiatric Interview\r\n\r\n          3. Plans to remain in San Diego region for at least 6 months,\r\n\r\n          4. Capable of informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Not English speaking\r\n\r\n          2. Cannot complete the assessment battery;\r\n\r\n          3. Insufficient visual acuity/manual dexterity for navigating a touch screen;\r\n\r\n          4. Current intoxication or substance use requiring immediate detoxification or outpatient\r\n             plan directed at substance abuse services (versus mental health services which are\r\n             separate in San Diego county);\r\n\r\n          5. Under conservatorship requiring proxy consent.\r\n      ","sponsor":"University of California, San Diego","sponsor_type":"Other","conditions":"Schizophrenia|Bipolar Disorder|Suicide and Self-harm","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Safety and Recovery Therapy","description":"4 session individualized psychoeducation tailored to people with bipolar disorder or schizophrenia targeting coping skills for suicidal thoughts and their determinants."},{"intervention_type":"Behavioral","name":"Behavioral: Mobile Augmentation","description":"Though a smartphone device, participants receive 12 weeks of personalized prompts derived from content produced in individual START sessions to increase transfer of skills to day to day life"}],"outcomes":[{"outcome_type":"primary","measure":"Scale for Suicide Ideation","time_frame":"Change in severity of suicide ideation over 24 weeks","description":"21 Item clinician rated scale"},{"outcome_type":"secondary","measure":"Columbia Suicide Severity Rating Scale - Interval Version","time_frame":"Rate of suicidal behavior over 24 weeks","description":"Measure of the presence and severity of ideation and behavior over a defined interval"}]}
{"nct_id":"NCT03519828","start_date":"2018-03-01","enrollment":100,"brief_title":"Oxidation-reduction Homeostasis in Cognitive Impairment Patients After Stroke","official_title":"Effects of Oxidation-reduction Homeostasis on Cognitive Impairment in Patients With Ischemic Stroke","primary_completion_date":"2018-12-30","study_type":"Observational","rec_status":"Completed","completion_date":"2019-01-01","last_update":"2019-07-31","description":"Cognitive impairment after ischemic stroke can affect not only the social adaptation ability, but also affect the comprehensive rehabilitation of patients. The damage of cognitive impairment after ischemic stroke is not lower than the body function defect after stroke. Many studies have shown that oxidative stress is one of the pathophysiological mechanisms of ischemic cerebrovascular disease. Many studies have reported that the oxidative-reduction of cells plays an important role in the life activities of organisms, affecting the health, aging and death of the organism. In the recent years, some scholars have suggested that post-stroke cognitive impairment may be related to oxidative-reduction homeostasis of the body, but the relevant evidence is lacking and needs to be further explored. Therefore, the purpose of this study is to explore the effect of oxidation-reduction homeostasis on cognitive impairment in patients with ischemic stroke, and provide a theoretical basis for the prevention and treatment of cognitive impairment after ischemic stroke.","other_id":"k(2017)34","observational_model":"Case-Control","time_perspective":"Retrospective","sampling_method":"Probability Sample","gender":"All","minimum_age":40,"maximum_age":80,"population":"Acute ischemic stroke patients in hospital from March, 2018 to September, 2018.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  40-80 years old;\r\n\r\n          -  Ischemic stroke for the first time or previous stroke but with no serious sequelae\r\n             (mRS is 0 -2 points);\r\n\r\n          -  Time from onset to treatment 48 hours;\r\n\r\n          -  Conscious awareness, and with no obvious aphasia and visual impairment;\r\n\r\n          -  Signed informed consent by patient self or legally authorized representatives.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Intracranial hemorrhage or suspected subarachnoid hemorrhage;\r\n\r\n          -  Transient ischemic attack;\r\n\r\n          -  Patients with severe mental disorders or language disorders;\r\n\r\n          -  Patients can not cooperate with evaluators, such as mental illness or dementia;\r\n\r\n          -  Pregnant women or suckers;\r\n\r\n          -  Researchers consider patients inappropriate to participate in the registry.\r\n      ","sponsor":"Hui-Sheng Chen","sponsor_type":"Other","conditions":"Oxidative-reduction Homeostasis|Post-stroke Cognitive Impairment","interventions":[{"intervention_type":"Other","name":"Other: No intervention has been conducted","description":"It is an observational study, and no intervention has been conducted"}],"outcomes":[{"outcome_type":"primary","measure":"Oxidative-reduction homeostasis in acute ischemic stroke patients","time_frame":"1 day","description":"Reduced glutathione (GSH)/ Oxidized glutathione (GSSG), Superoxide dismutase (SOD), Catalase (CAT), Glutathione Peroxidase (GSH-PX) of acute ischemic stroke patients will be tested."},{"outcome_type":"primary","measure":"Cognitive function in acute ischemic stroke patients","time_frame":"1 day","description":"Mini Mental Status Examination (MMSE) and Montreal cognitive assessment scale (MoCA) in acute ischemic stroke patients will be evaluated."}]}
{"nct_id":"NCT03454217","start_date":"2018-03-01","phase":"Phase 4","enrollment":60,"brief_title":"Impact of Tramadol and Oxycodone on Sleep Apnea","official_title":"Impact of Tramadol and Oxycodone on Sleep Apnea","primary_completion_date":"2020-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-09-30","last_update":"2021-01-27","description":"Postoperative pain is usually treated with opioids. Among them, oxycodone is popular in the daily practice as it is administered orally and is easily titrated. However, side-effects include increase duration and frequency of apneic episodes. Some authors believe that tramadol has less impact on these apneic episodes during the first postoperative night, based on a trial that reported conclusive results only during the first 2 postoperative hours. The objective of this randomized controlled trial is to compare the effect of postoperative pain treatment of oxycodone with tramadol on apneic episodes during the first and third postoperative nights.","other_id":"CER 2017-01976","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  patients scheduled for orthopaedic surgery on the lower limb under a spinal\r\n             anaesthesia\r\n\r\n          -  physical status I-III\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  planned surgical duration more than 3 hours\r\n\r\n          -  contraindication to spinal anaesthesia\r\n\r\n          -  severe respiratory disease\r\n\r\n          -  patient treated for sleep apnea syndrome\r\n\r\n          -  allergy to tramadol or oxycodone\r\n      ","sponsor":"Centre Hospitalier Universitaire Vaudois","sponsor_type":"Other","conditions":"Sleep Apnea","interventions":[{"intervention_type":"Drug","name":"Drug: Oxycodone","description":"Postoperative pain treatment with oxycodone"},{"intervention_type":"Drug","name":"Drug: Tramadol","description":"Postoperative pain treatment with tramadol"}],"outcomes":[{"outcome_type":"secondary","measure":"Pains scores (numeric rating scale)","time_frame":"Postoperative day 0, 1, 2 and 3"},{"outcome_type":"secondary","measure":"Opioid (oxycodone or tramadol) consumption","time_frame":"Postoperative day 0, 1, 2 and 3"},{"outcome_type":"secondary","measure":"Apnea hypopnea index in another position than supine","time_frame":"Postoperative night 1"},{"outcome_type":"secondary","measure":"Mean pulse oxymetry","time_frame":"Postoperative night 1"},{"outcome_type":"secondary","measure":"Apnea hypopnea index while lying supine","time_frame":"Postoperative night 3"},{"outcome_type":"secondary","measure":"Apnea hypopnea index in another position than supine","time_frame":"Postoperative night 3"},{"outcome_type":"secondary","measure":"Mean pulse oxymetry","time_frame":"Postoperative night 3"},{"outcome_type":"primary","measure":"Apnea hypopnea index while lying supine","time_frame":"Postoperative night 1","description":"Apnea hypopnea index while lying supine"}]}
{"nct_id":"NCT03361228","start_date":"2018-03-01","phase":"Phase 1/Phase 2","enrollment":5,"brief_title":"A Study to Evaluate the Safety, Tolerability, and Antitumor Activity of INCB001158 Plus Epacadostat, With or Without Pembrolizumab, in Advanced Solid Tumors","official_title":"An Open-Label, Multicenter, Nonrandomized, Dose-Escalation, and Tumor-Expansion Phase 1/2 Study to Evaluate the Safety, Tolerability, and Antitumor Activity of INCB001158 Plus Epacadostat (INCB024360), With or Without Pembrolizumab, in Subjects With Advanced Solid Tumors","primary_completion_date":"2019-03-30","study_type":"Interventional","rec_status":"Terminated","completion_date":"2019-03-30","last_update":"2020-05-21","description":"The purpose of this study is to assess the safety and antitumor activity of INCB001158 plus epacadostat, with or without pembrolizumab, in participants with advanced or metastatic solid tumors.","other_id":"INCB 01158-202","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  For Phase 1, subjects with histologically or cytologically confirmed advanced or\r\n             metastatic solid tumors that have failed prior standard therapy (disease progression;\r\n             subject intolerance is also allowable).\r\n\r\n          -  For Phase 2, subjects with the following tumor types who meet protocol-defined\r\n             criteria: advanced or metastatic NSCLC, melanoma, urothelial carcinoma, SCCHN, SCLC,\r\n             and CRC.\r\n\r\n          -  Presence of at least 1 measurable lesion by computed tomography or magnetic resonance\r\n             imaging per RECIST v1.1.\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.\r\n\r\n          -  Resolution of all toxicities and any toxic effect(s) of the most recent prior therapy\r\n             to Grade 1 or less (except alopecia). Subjects with  Grade 2 neuropathy are an\r\n             exception and may enroll.\r\n\r\n          -  Adequate renal, hepatic, and hematologic functions per protocol-defined laboratory\r\n             parameters within  7 days before treatment initiation.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Participation in any other study in which receipt of an investigational study drug or\r\n             device occurred within 2 weeks or 5 half-lives (whichever is longer) before first\r\n             dose.\r\n\r\n          -  Has received a prior monoclonal antibody within 4 weeks or 5 half-lives (whichever is\r\n             shorter) before administration of study drug.\r\n\r\n          -  Prior chemotherapy or targeted small molecule therapy within 2 weeks before\r\n             administration of study treatment.\r\n\r\n          -  Prior therapy with an IDO1 or arginase 1 inhibitor.\r\n\r\n          -  Active autoimmune disease that has required systemic treatment in past 2 years.\r\n             Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement\r\n             therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of\r\n             systemic treatment.\r\n\r\n          -  Receipt of a live vaccine within 30 days before the first dose of study treatment.\r\n\r\n          -  Any history of serotonin syndrome after receiving serotonergic drugs.\r\n\r\n          -  Use of protocol-defined prior/concomitant therapy.\r\n\r\n          -  Known or suspected defect in the function of the urea cycle.\r\n\r\n          -  History of gastrointestinal condition that may affect drug absorption.\r\n      ","sponsor":"Incyte Corporation","sponsor_type":"Industry","conditions":"Solid Tumors","interventions":[{"intervention_type":"Drug","name":"Drug: INCB001158","description":"Phase 1: INCB001158 administered orally twice daily at the protocol-defined dose. Phase 2: INCB001158 administered orally twice daily at the recommended dose from Phase 1."},{"intervention_type":"Drug","name":"Drug: Epacadostat","description":"Epacadostat at the protocol-defined dose administered orally twice daily."},{"intervention_type":"Drug","name":"Drug: Pembrolizumab","description":"Pembrolizumab at the protocol-defined dose administered intravenously every 3 weeks."}],"outcomes":[{"outcome_type":"primary","measure":"Phase 1 Only: Safety and Tolerability of INCB001158 in Combination With Epacadostat ± Pembrolizumab as Assessed by Number of Participants With a Treatment-emergent Adverse Event (TEAE)","time_frame":"Up to approximately 12 months per subject","description":"TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment."},{"outcome_type":"primary","measure":"Phase 2 Only: Objective Response Rate (ORR) of INCB001158 in Combination With Epacadostat ± Pembrolizumab","time_frame":"Up to approximately 12 months per subject","description":"Defined as percentage of subjects having a complete response (CR) or partial response (PR) based on investigator assessment per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)."},{"outcome_type":"secondary","measure":"Phase 2 Only: Safety and Tolerability of INCB001158 in Combination With Epacadostat ± Pembrolizumab as Assessed by Number of Participants With a TEAE","time_frame":"Up to approximately 12 months per subject","description":"TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment."},{"outcome_type":"secondary","measure":"Phase 1 Only: ORR With INCB001158 in Combination With Epacadostat ± Pembrolizumab","time_frame":"Up to approximately 12 months per subject","description":"Defined as percentage of subjects having a CR or PR based on investigator assessment per RECIST v1.1."},{"outcome_type":"secondary","measure":"Disease Control Rate With INCB001158 in Combination With Epacadostat ± Pembrolizumab","time_frame":"Up to approximately 12 months per subject","description":"Defined as percentage of subjects having CR, PR, or stable disease for at least 56 days based on investigator assessment per RECIST v1.1."},{"outcome_type":"secondary","measure":"Duration of Response With INCB001158 in Combination With Epacadostat ± Pembrolizumab","time_frame":"Up to approximately 12 months per subject","description":"Defined as the time from earliest date of disease response until the earliest date of disease progression per RECIST v1.1, or death due to any cause, if occurring sooner than progression."},{"outcome_type":"secondary","measure":"Progression-free Survival With INCB001158 in Combination With Epacadostat ± Pembrolizumab","time_frame":"Up to approximately 12 months per subject","description":"Defined as the time from date of first dose of study treatment until the earliest date of disease progression (based on investigator assessment of per RECIST v1.1) or death due to any cause, if occurring sooner than progression."},{"outcome_type":"secondary","measure":"Plasma Pharmacokinetic Profile of INCB001158 and Epacadostat","time_frame":"Up to approximately 1 month","description":"Noncompartmental method of analysis will be used to analyze the plasma concentrations of INCB001158 and epacadostat."}]}
{"nct_id":"NCT03417843","start_date":"2018-02-28","phase":"N/A","enrollment":20,"brief_title":"Safety and Efficacy of an Ablation Catheter for the Treatment of Pancreatic Premalignant Cyctic Lesions.","official_title":"A Prospective, Open Label Study: Safety and Efficacy of a New Ablation Catheter RFA (Radiofrequency Under EUS) Developed by TAEWOONG Company for the Treatment of Pancreatic Premalignant and Early Malignant Cyctic Lesions.","primary_completion_date":"2020-02-29","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2021-02-28","last_update":"2018-02-13","description":"This study aims to evaluate the safety and efficacy of new ablation catheter developed by MEDICAL TAEWOONG for the treatment of pancreatic premalignant and early malignant cystic lesion. The ablation is performed using EUSRA needle and radiofrequncy waves under ultrasound imaging. The method will be exaimened on patients who are candidates for surgical intervention and to examine the ability of the method to serve as an alternative to surgical intervention.","other_id":"0090-17-EMC","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"A Prospective, open- label study","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients aged 18-85\r\n\r\n              Patients who agreed to join study and signed an informed consent letter\r\n\r\n          -  Patients with IPMN pancreas cystic tumor with a diameter greater than 30 mm and with\r\n             secondary branches.\r\n\r\n               -  Patients with a tissue component within the cystic lesion\r\n\r\n               -  Patients with atypical cells in cytology, regardless of the size of the lesion\r\n                  and regardless of the contents of the cyst\r\n\r\n               -  Patients with a lesion of less than 30 mm diameter showing rapid changes in size\r\n                  (15 mm increments followed by 6 months)\r\n\r\n               -  Patients with a consistent increase in CEA level within the cyst.\r\n\r\n               -  Patients with cystinus cystadenoma of any size with suspicious signs such as\r\n                  thickening of the cyst wall, calcification of the cyst wall, irregularity of the\r\n                  cyst wall, tissue content within the cyst, the presence of atypical cells within\r\n                  the cyst in cytology.\r\n\r\n               -  Symptomatic patients (pain defined as related to the lesion)\r\n\r\n               -  Asymptomatic patients with a normal cyst greater than 40 mm in diameter.\r\n\r\n               -  Patients referred for surgical treatment (after the multidisciplinary committee\r\n                  (gastroenterologists, surgeons and pathologists / cytologists) has approved the\r\n                  diagnosis and indication of therapeutic intervention (as is customary) but not\r\n                  suitable for surgery due to high risk of anesthesia (ASAIV) or severe anatomy due\r\n                  to repeat surgery or patients who do not agree to undergo surgical intervention\r\n                  (these are most patients)\r\n\r\n               -  Patients with low anesthetic risk: ASA 1-3.\r\n\r\n               -  Women who are not pregnant during recruitment, and women of childbearing age who\r\n                  take birth control during the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with clear evidence of invasive tumor development within the lesion (both\r\n             candidates and not candidates for continued surgical treatment).\r\n\r\n          -  Patients with severe coagulation disorders (PT, elongated PTT)\r\n\r\n          -  Patients with platelet counts less than 75000\r\n\r\n          -  Patients taking anticoagulants that can not be stopped temporarily\r\n\r\n          -  Patients with pacemakers\r\n\r\n          -  Patients with dilatation pages\r\n\r\n          -  Patients who take clopidogrel in situations that do not allow temporary cessation of\r\n             the drug.\r\n\r\n          -  Patients with hight anesthetic risk(ASA4 group).\r\n\r\n          -  Patients belonging to groups: pregnant women, nursing patients, and demineral\r\n             patients.\r\n\r\n          -  Women of childbearing age who do not take birth control.\r\n\r\n          -  Patients who are unable to express informed consent.\r\n      ","sponsor":"HaEmek Medical Center, Israel","sponsor_type":"Other","conditions":"Pancreatic Cancer|Pancreatic Neuroendocrine Tumor|Pancreatic Cyst|Pancreatic Cancer Stage","interventions":[{"intervention_type":"Device","name":"Device: EUSRA RF electrode","description":"At the tip of the needle there is a probe that releases the peripheral energy in a continuous and continuous manner. The method is a long 50W power release for 10 seconds or 40W until white bubbles appear in a sonographic image.\r\nMaterials that come into contact with the body: electrode and grounding surfaces"}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of adverse and serious adverse events","time_frame":"up to one month post-procedure","description":"The number of subjects with post EUS-RFA-related adverse events including:\r\nFever >38C (will be measured in celcius)"},{"outcome_type":"primary","measure":"Incidence of adverse and serious adverse events","time_frame":"up to 72 hours post-procedure","description":"The number of subjects with post EUS-RFA-related adverse events including:\r\nPancreatitis as measured by an increase of at least 3 times in serum amylase (units/liter) in the initial 72 hours post-procedure"},{"outcome_type":"primary","measure":"Incidence of adverse and serious adverse events","time_frame":"up to 72 hours post-procedure","description":"The number of subjects with post EUS-RFA-related adverse events including:\r\nHemorrhage as measured by need for transfusion of packed red blood cells"},{"outcome_type":"primary","measure":"Incidence of adverse and serious adverse events","time_frame":"up to 72 hours post-procedure","description":"The number of subjects with post EUS-RFA-related adverse events including:\r\nPerforation as confirmed by abdominal CT"},{"outcome_type":"primary","measure":"Incidence of adverse and serious adverse events","time_frame":"up to 12 months post-procedure","description":"The number of subjects with post EUS-RFA-related adverse events including:\r\nMortality"},{"outcome_type":"secondary","measure":"Absolute disappearance incidence or reduction in lesion size","time_frame":"up to 12 months post-procedure (3, 6 and 12 months post-procedure)","description":"Direct measuring of lesion diameter and area (in milimeter and milimeter^2 respectively) during the 12-month blind follow-up by EUS, CT and MRI ."},{"outcome_type":"secondary","measure":"Absolute disappearance incidence or reduction in lesion size","time_frame":"up to 12 months post-procedure (3, 6 and 12 months post-procedure)","description":"disappearance of mural nodule inside cyst follow-up by EUS, CT and MRI ."},{"outcome_type":"secondary","measure":"Technical efficiency of the method","time_frame":"during the procedure","description":"To examine the technical efficiency of the method by estimating the frequency of success in performing the operation according to the protocol, without any mishaps and deviations from the original protocol."}]}
{"nct_id":"NCT03576612","start_date":"2018-02-27","phase":"Phase 1","enrollment":36,"brief_title":"GMCI, Nivolumab, and Radiation Therapy in Treating Patients With Newly Diagnosed High-Grade Gliomas","official_title":"Phase I Study of Neoadjuvant GMCI Plus Immune Checkpoint Inhibitor Combined With Standard of Care for Newly Diagnosed High-Grade Gliomas","primary_completion_date":"2022-02-22","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2022-10-28","last_update":"2021-09-10","description":"The purpose of this phase I trial is to test the safety of combining GMCI, an immunostimulator, plus nivolumab, an immune checkpoint inhibitor (ICI), with standard of care radiation therapy, and temozolomide in treating patients with newly diagnosed high-grade gliomas. Gene Mediated Cytotoxic Immunotherapy (GMCI) involves the use of aglatimagene besadenovec (AdV-tk) injection into the tumor site and oral valacyclovir to kill tumor cells and stimulate the immune system. Nivolumab is an immune checkpoint inhibitor that may also stimulate the immune system by blocking the PD-1 immune suppressive pathway. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors and temozolomide is a chemotherapy drug that kills tumor cells. Giving GMCI, nivolumab, radiation therapy, and temozolomide may work better in treating patients with high-grade gliomas","other_id":"ABTC-1603","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Newly diagnosed HGG: surgically eligible patients AdV-tk into wall of resection cavity; 1-3 days post-surgery Valacyclovir d1-14; Day 8 RT for 6 wks; day 15 TMZ 75mg/m2 daily; Nivo 240mgIV every 2 weeks","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients must have operable brain tumor presumed to be high grade glioma (HGG) based\r\n             on clinical and radiologic evaluation, where a gross total surgical resection of the\r\n             contrast-enhancing area is intended; pathologic confirmation of HGG must be made at\r\n             the time of surgery prior to AdV-tk injection, if not previously determined\r\n\r\n          -  Patients must have a Karnofsky performance status >= 70% (i.e. the patient must be\r\n             able to care for himself/herself with occasional help from others)\r\n\r\n          -  Absolute neutrophil count >= 1,500/uL\r\n\r\n          -  Platelets >= 100,000/uL\r\n\r\n          -  Hemoglobin >= 9 g/dL\r\n\r\n          -  Total bilirubin =< 1.5 x institutional upper limit of normal (ULN), (except for\r\n             patients with known Gilbert's syndrome who must have normal direct bilirubin)\r\n\r\n          -  Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase\r\n             (SGOT)/alanine aminotransaminase (ALT) serum glutamate pyruvate transaminase (SGPT) =<\r\n             3.0 x institutional ULN\r\n\r\n          -  Creatinine =< institutional ULN\r\n\r\n          -  Calculated creatinine clearance >= 40 ml/min (use a modified Cockcroft-Gault equation)\r\n\r\n          -  Activated partial thromboplastin time/partial thromboplastin time (APTT/PTT) =< 1.5 x\r\n             institutional ULN\r\n\r\n          -  Patients must be able to provide written informed consent\r\n\r\n          -  Patients must have magnetic resonance imaging (MRI) within 14 days of starting\r\n             treatment; patients must be able to tolerate MRI\r\n\r\n          -  Women of childbearing potential must agree to have a negative serum pregnancy test\r\n             within 24 hours prior to treatment start; women of childbearing potential must agree\r\n             to use adequate contraception (hormonal or barrier method of birth control;\r\n             abstinence) prior to study entry, for the duration of study treatment, and through at\r\n             least 5 months after the last dose of study drug; should a woman become pregnant or\r\n             suspect she is pregnant while participating in this study, she should inform her\r\n             treating physician immediately; sexually active men of reproductive potential who are\r\n             partners of women with reproductive potential must also agree to use adequate\r\n             contraception prior to the study, for the duration of study participation, and through\r\n             at least 7 months after the last dose of study drug; adequate methods of effective\r\n             birth control include sexual abstinence (men, women); vasectomy; or a condom with\r\n             spermicide (men) in combination with barrier methods, hormonal birth control or\r\n             intrauterine device (IUD) (women)\r\n\r\n          -  Patients must have no concurrent malignancy except curatively treated basal or\r\n             squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or\r\n             bladder; patients with prior malignancies must be disease-free for >= two years;\r\n             patients with low-risk prostate cancer on active surveillance are eligible\r\n\r\n          -  Patients must be able to swallow oral medications\r\n\r\n          -  Patients must not have received prior radiation therapy, chemotherapy, immunotherapy\r\n             or therapy with biologic agent (including immunotoxins, immunoconjugates, antisense,\r\n             peptide receptor antagonists, interferons, interleukins, tumor infiltrating lymphocyte\r\n             [TIL], lymphokine-activated killer [LAK] or gene therapy), or hormonal therapy for\r\n             their brain tumor; glucocorticoid therapy is allowed\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients receiving any other investigational agents are ineligible\r\n\r\n          -  Patients with a history of hypersensitivity or allergic reactions attributed to\r\n             compounds of similar chemical or biologic composition to valacyclovir, acyclovir, or\r\n             temozolomide are ineligible; the valacyclovir and temozolomide package inserts can be\r\n             referenced for more information\r\n\r\n          -  Patients with a history of severe hypersensitivity reaction to any monoclonal antibody\r\n             are ineligible\r\n\r\n          -  Patients who require therapy with systemic immunosuppressive drugs except\r\n             corticosteroids are ineligible\r\n\r\n          -  Patients with a history of active autoimmune disease requiring treatment in the past 2\r\n             years are ineligible\r\n\r\n          -  Patients with uncontrolled intercurrent illness including, but not limited to, ongoing\r\n             or active infection, symptomatic congestive heart failure, unstable angina pectoris,\r\n             cardiac arrhythmia, active liver disease or active hepatitis, or psychiatric\r\n             illness/social situations that would limit compliance with study requirements, are\r\n             ineligible\r\n\r\n          -  Pregnant women are excluded from this study; breastfeeding should be discontinued if\r\n             the mother is treated with these agents through 1 week after receiving the last dose\r\n             of study drugs\r\n\r\n          -  Patients who are known to be human immunodeficiency virus (HIV) positive are\r\n             ineligible\r\n      ","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","sponsor_type":"Other","conditions":"Glioma, Malignant","interventions":[{"intervention_type":"Biological","name":"Biological: AdV-tk","description":"Given IT"},{"intervention_type":"Drug","name":"Drug: Valacyclovir","description":"Given PO days 1-14; 1-3 days post surgery"},{"intervention_type":"Radiation","name":"Radiation: Radiation","description":"Undergo RT, 60Gy in 30 daily fractions M-F for 6weeks"},{"intervention_type":"Drug","name":"Drug: Temozolomide","description":"Given PO during RT 75mg/m2 daily during RT Post RT cycle 1: 150mg/m2 days 1-5 150mg/m2 cycle 2-6: days 1-5 (150-200mg/m2)"},{"intervention_type":"Biological","name":"Biological: Nivolumab","description":"day 15 post surgery 240mg IV q2wks x 26 doses , up to 52 weeks"},{"intervention_type":"Other","name":"Other: Laboratory Biomarker Analysis","description":"correlative studies"}],"outcomes":[{"outcome_type":"secondary","measure":"Tumor mutation - Tumor Tissue","time_frame":"Up to 2 years","description":"Mutational profiling by sequence or transcriptome analysis from tumor tissue"},{"outcome_type":"primary","measure":"Incidence of adverse events","time_frame":"Up to 2 years","description":"National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 will be used for scoring toxicity and adverse events. The severity and frequency of toxicity will be tabulated by the tested dose or doses using descriptive statistics. The proportions of subjects who experienced grade 3 or above toxicities will be estimated, along with 95% confidence intervals by each type of toxicity."},{"outcome_type":"secondary","measure":"Overall survival (death)","time_frame":"From initial diagnosis to the date of death/or censored at the time of last known alive, assessed for up to 2 years","description":"To estimate overall survival - endpoint is death. Median time of survival along with 95% confidence interval will be estimated using the Kaplan-Meier method."},{"outcome_type":"secondary","measure":"Progression-free survival (progression)","time_frame":"From initial diagnosis to the date progression is defined, assessed for up to 2 years","description":"To estimate progression-free survival - endpoint is progression. Median time of progression-free survival along with 95% confidence interval will be estimated using Kaplan-Meier method."},{"outcome_type":"secondary","measure":"Immune profiling - Tumor Tissue","time_frame":"Up to 2 years","description":"Tumor profiling by immunohistochemistry and Nanostring at baseline and when samples available after treatment."},{"outcome_type":"secondary","measure":"Peripheral blood mononuclear cells (PBMCs) in serum samples","time_frame":"Up to 2 years","description":"Standard descriptive statistics will be used to summarize proportion of PBMCs."},{"outcome_type":"secondary","measure":"Immune characterization as determined by Cytokines","time_frame":"Up to 2 years","description":"Immune characterization of surface and content proteins is determined by presence of cytokines in serum."},{"outcome_type":"secondary","measure":"Immune characterization as determined by Extracellular vesicles (EVs) proteins","time_frame":"Up to 2 years","description":"Immune characterization of surface and content proteins based on presence of extracellular vesicles in serum samples."}]}
{"nct_id":"NCT03455972","start_date":"2018-02-20","phase":"Phase 1/Phase 2","enrollment":15,"brief_title":"Study of T Cells Targeting CD19/BCMA (CART-19/BCMA) for High Risk Multiple Myeloma Followed With Auto-HSCT","official_title":"Study of T Cells Targeting CD19/BCMA (CART-19/BCMA) for High Risk Multiple Myeloma Followed With Auto-HSCT","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-12-31","last_update":"2021-05-19","description":"CART therapy has showed good safety and efficacy in treatment of lymphoma and acute lymphoblastic leukemia. Researchers want to see if this helps people with high risk multiple myeloma after auto-HSCT.To test the safety and efficacy of giving targeting CD19 and BCMA T cells in treating high risk multiple myeloma followed with auto-HSCT.","other_id":"myeloma-03","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Multiple myeloma patients eligible for auto-HSCT.\r\n\r\n          -  High risk multiple myeloma (R-ISS III stage or with extramedullary infiltration or\r\n             with del(17p), t(4;14), t(14;16), t(14;20), 1q21+ or disease progression during\r\n             treatment).\r\n\r\n          -  Expected survival  3 months.\r\n\r\n          -  Creatinine < 2.0 mg/dl.\r\n\r\n          -  Blood coagulation function: PT and APTT <2x normal.\r\n\r\n          -  Arterial blood oxygen saturation>92%.\r\n\r\n          -  ALT(alanine aminotransferase)/AST (aspartate aminotransferase)< 3x normal\r\n\r\n          -  Karnofsky scores  60 and ECOG score2.\r\n\r\n          -  Adequate venous access for apheresis, and no other contraindications for\r\n             leukapheresis.\r\n\r\n          -  Patients should not take immunotherapy in three months prior to CART cells infusion.\r\n\r\n          -  Voluntary informed consent is given.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnant or lactating women.\r\n\r\n          -  Uncontrolled active infection.\r\n\r\n          -  Active hepatitis B or hepatitis C infection.\r\n\r\n          -  Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not\r\n             exclusionary.\r\n\r\n          -  Previously treatment with any gene therapy products.\r\n\r\n          -  Any uncontrolled active medical disorder that would preclude participation as\r\n             outlined.\r\n\r\n          -  HIV infection.\r\n\r\n          -  History of myocardial infarction and severe arrhythmia in half a year.\r\n\r\n          -  Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency\r\n             Disease).\r\n\r\n          -  Patients with fever of unknown origin (T>38).\r\n      ","sponsor":"The First Affiliated Hospital of Soochow University","sponsor_type":"Other","conditions":"Safety and Efficacy","interventions":[{"intervention_type":"Biological","name":"Biological: anti-CD19 and anti-BCMA CAR","description":"Participants will get auto-HSCT. Hematopoietic reconstitution after auto-HSCT, participants will get the anti-CD19 CAR T cells (110e+7/kg on d0) and anti-BCMA CAR T cells as split-dose (total 510e+7/kg, 40% on d1 and 60% on d2)"},{"intervention_type":"Drug","name":"Drug: Immunomodulatory drugs","description":"Maintenance therapy"}],"outcomes":[{"outcome_type":"primary","measure":"Incidence and severity of adverse events","time_frame":"Approximately 3 years","description":"Proportion of subjects with adverse events overall and by severity grade"},{"outcome_type":"primary","measure":"PFS","time_frame":"Minimum of 2 years after first induction","description":"Is defined as time from first induction date to first documentation of PD, or death due to any cause, whichever occurs first."},{"outcome_type":"primary","measure":"OS","time_frame":"Minimum of 2 years after first induction","description":"Is defined as time from first induction date to time of death due to any cause"},{"outcome_type":"secondary","measure":"Duration of best response","time_frame":"Minimum of 2 years","description":"According to IMWG response criteria at the end of the research."},{"outcome_type":"secondary","measure":"MRD negative conversion ratio and persistence","time_frame":"Minimum of 2 years","description":"MRD negative by flow cytometry"},{"outcome_type":"secondary","measure":"Proportion of subjects who achieved Complete Response (CR) Rate","time_frame":"Minimum of 2 years","description":"Percentage of subjects who achieved CR or stringent CR according to IMWG Uniform Response Criteria for Multiple Myeloma"},{"outcome_type":"secondary","measure":"Pharmacokinetics - Cmax","time_frame":"Approximately 2.5 years after first CAR infused","description":"Maximum transgene level"},{"outcome_type":"secondary","measure":"Pharmacokinetics - Tmax","time_frame":"Approximately 2.5 years after first CAR infused","description":"Time to peak transgene level"},{"outcome_type":"secondary","measure":"Pharmacokinetics - AUC","time_frame":"Approximately 2.5 years after first CAR infused","description":"Area under the curve of the transgene level"},{"outcome_type":"secondary","measure":"Duration of persistence of CAR T cells in the blood","time_frame":"Approximately 2.5 years after first CAR infused","description":"Duration of persistence of CAR T cells in the blood"}]}
{"nct_id":"NCT03438149","start_date":"2018-02-20","enrollment":300,"brief_title":"Microparticles in Obstructive Sleep Apnea","official_title":"Microparticles as a Biomarker of Incident Cardiovascular Risk in Patients With Obstructive Sleep Apnea","primary_completion_date":"2026-02-20","study_type":"Observational","rec_status":"Recruiting","completion_date":"2026-02-20","last_update":"2019-01-16","description":"Obstructive sleep apnea (OSA) is independently associated with cardiovascular diseases, including myocardial infarction and stroke. OSA may promote atherosclerosis risk factors such as hypertension, diabetes and dyslipidemia and may have direct proatherogenic effects on the vascular wall. A growing number of studies have recently focused on the role of microparticles (MPs) in the atherogenic process. Case-control studies have shown that platelet-, endothelial- and leukocyte-derived MP levels are increased in OSA and that leukocyte-derived MP are released during the night in OSA. Furthermore, experimental evidence shows that MPs from OSA patients induce endothelial dysfunction. The objective of this prospective study is to evaluate the impact of increased levels of leukocyte derived MPs on the cardiovascular outcomes in patients with prevalent cardiovascular diseases investigated for OSA.","other_id":"2017-A02494-49","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patient with prevalent cardiovascular diseases referred to a sleep clinic for suspected\r\n        OSA.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  diagnosis of coronary artery disease or cerebrovascular disease\r\n\r\n          -  diagnosis of moderate-to-severe OSA\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  pregnancy\r\n\r\n          -  previously treated OSA\r\n      ","sponsor":"University Hospital, Angers","sponsor_type":"Other","conditions":"Sleep Apnea, Obstructive","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"death from any cardiovascular cause","time_frame":"first event within 5 years after inclusion","description":"outcomes assessed every year at the follow up visit or by calling the primary care physician"},{"outcome_type":"primary","measure":"myocardial infarction (acute infarct or silent myocardial infarction or unstable angina)","time_frame":"first event within 5 years after inclusion","description":"outcomes assessed every year at the follow up visit or by calling the primary care physician"},{"outcome_type":"primary","measure":"cerebrovascular infarction (stroke or transient ischemic attack)","time_frame":"first event within 5 years after inclusion","description":"outcomes assessed every year at the follow up visit or by calling the primary care physician"},{"outcome_type":"primary","measure":"hospitalization for heart failure","time_frame":"first event within 5 years after inclusion","description":"outcomes assessed every year at the follow up visit or by calling the primary care physician"}]}
{"nct_id":"NCT03417167","start_date":"2018-02-14","enrollment":201,"brief_title":"Indications and Interest of US-guided Synovial Biopsies Performed in Clinical Practice","official_title":"\"Interest of Synovial Biopsy in the Etiological Assessment of Arthritis of Undetermined Origin: Multicenter Prospective Series\"","primary_completion_date":"2020-09-11","study_type":"Observational","rec_status":"Completed","completion_date":"2020-09-11","last_update":"2020-10-22","description":"Synovial biopsies are now routinely performed both in research and in clinical practice. The developments of ultrasound (US) and of US-guided needle biopsies devices have facilitated their use and tolerance by the patients. However, their interest in clinical practice in the context of an undifferentiated arthritis remains debated.","other_id":"RC17_0440","observational_model":"Other","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Age under 18 year old, pregnancy, breastfeeding","criteria":"\n        Inclusion Criteria:\r\n\r\n        All patients undergoing an US-guided synovial biopsy in clinical practice in the context of\r\n        an arthritis of unknown origin\r\n\r\n        Exclusion Criteria:\r\n      ","sponsor":"Nantes University Hospital","sponsor_type":"Other","conditions":"Arthritis","interventions":[{"intervention_type":"Other","name":"Other: US-guided synovial biopsy","description":"Needle Synovial biopsy performed using a Tru-cut device."}],"outcomes":[{"outcome_type":"primary","measure":"number of cases where the synovial biopsy allows drawing a definite diagnosis","time_frame":"10 days","description":"Final diagnosis will be classified in 5 groups: infectious, crystal induced arthritis, tumoral, inflammatory rheumatisms, others (amyloidosis etc …)"},{"outcome_type":"secondary","measure":"Indications, tolerance, complications, number and type of analysis for each sample, results of pathology, bacteriology, mycobacteriology","time_frame":"1 month","description":"For each biopsy, the indications, clinical presentation, procedure (length, tolerance), biopsy results (Pathology, bacteriology, etc ...) will be collected in a Clinical Research Form."}]}
{"nct_id":"NCT03183440","start_date":"2018-02-13","phase":"N/A","enrollment":376,"brief_title":"Efficacy Of Antenatal Maternal Supplementation With GOS/Inulin Prebiotics On Atopic Dermatitis Prevalence In High-Risk One-Year-Old Children","official_title":"A Multicenter Clinical Trial To Assess The Efficacy Of Antenatal Maternal Supplementation With GOS/Inulin Prebiotics On Atopic Dermatitis Prevalence In High-Risk One-Year-Old Children.","primary_completion_date":"2023-08-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-08-31","last_update":"2021-06-16","description":"Allergies are increasing worldwide affecting 30-40% of the population. Among this, Atopic Dermatitis (AD) is the earliest and the most common manifestation of allergic diseases (prevalence 20%). Recent studies have shown that allergies were associated with a disruption of the gut microbial 'balance' suggesting that the use of nutritional intervention very early in life may restore an optimal pattern of microflora aiming at improving the host's health. So far, most human intervention studies have mainly focused on improving postnatal infant colonization. Our study will test the hypothesis that a maternal antenatal prebiotics (GOS/inulin) supplementation may be superior to placebo for AD prevention in high-risk children.","other_id":"RC16_0012","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Triple","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  pregnant women with an eutocic pregnancy before 20 weeks of gestation\r\n\r\n          -  women with personal history of atopy diagnosed by a healthcare Professional\r\n\r\n          -  Women accepting a complete avoidance of dietary supplements containing prebiotics or\r\n             probiotics during study supplementation\r\n\r\n          -  women accepting dermato-pediatric follow-up during the first year of life of the\r\n             new-born (Phone calls at 24 weeks of gestation and 6 months of child and a\r\n             consultation at 12 months of age)\r\n\r\n          -  non Tobacco user women\r\n\r\n          -  women over 18 years\r\n\r\n          -  women without history of severe gestational diabetes\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  women not giving up on intake of dietary supplements containing prebiotics or\r\n             probiotics during study supplementation\r\n\r\n          -  women refusing dermato-pediatric follow-up during the first year of the newborn\r\n\r\n          -  ongoing allergy and/or intolerance to cow's milk proteins\r\n\r\n          -  term >21 weeks of gestation\r\n      ","sponsor":"Nantes University Hospital","sponsor_type":"Other","conditions":"Dermatitis, Atopic","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: PREBIOTICS","description":"women will daily take a mixture of Galacto-Oligo-Saccharide/inulin (ratio 9:1) from inclusion to delivery"},{"intervention_type":"Other","name":"Other: PLACEBO","description":"women will daily take placebo (maltodextrin) from inclusion to delivery"}],"outcomes":[{"outcome_type":"primary","measure":"atopic dermatitis prevalence at M12","time_frame":"at 12 months of age","description":"prevalence will be evaluated according to UK party working group criteria"},{"outcome_type":"secondary","measure":"atopic dermatitis prevalence at M6","time_frame":"at 6 months of age","description":"prevalence will be evaluated by a phone questionnaire (ISAAC questionnaire)"},{"outcome_type":"secondary","measure":"atopic dermatitis severity","time_frame":"at 12 months of age","description":"evaluated by the SCORAD (Scoring Atopic Dermatitis)"},{"outcome_type":"secondary","measure":"atopic dermatitis severity","time_frame":"at 12 months of age","description":"evaluated by the POEM (Patient Oriented Eczema Measure)"},{"outcome_type":"secondary","measure":"Quality of life of the child and his/her family","time_frame":"at 12 months of age","description":"evaluated by the FDQLI score (Family Dermatitis Quality of life Index)"},{"outcome_type":"secondary","measure":"Tolerance of the prebiotics in mothers","time_frame":"from inclusion to delivery","description":"evaluated by a questionnaire on digestive status (bloating, stomach aches, diarrhea, flatulences,...)"},{"outcome_type":"secondary","measure":"sensitization with the major allergens","time_frame":"at 12 months of age","description":"skin prick tests"},{"outcome_type":"secondary","measure":"assessment of the Transepidermal Waterlos","time_frame":"at J1 and at 12 months of age","description":"evaluated by a TEWAMETER(R)"},{"outcome_type":"secondary","measure":"food allergies prevalence at M12","time_frame":"at 12 months of age","description":"Prevalence will be evaluated by recording food allergies diagnosed by a physician"}]}
{"nct_id":"NCT03400332","start_date":"2018-02-12","phase":"Phase 1/Phase 2","enrollment":372,"brief_title":"A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers","official_title":"A Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers","primary_completion_date":"2023-02-28","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2024-06-08","last_update":"2021-05-11","description":"The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.","other_id":"CA027-002","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please\r\n        visit www.BMSStudyConnect.com\r\n\r\n        Inclusion Criteria:\r\n\r\n          -  Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic,\r\n             recurrent and/or unresectable) with measurable disease per RECIST v1.1\r\n\r\n          -  At least 1 lesion accessible for biopsy\r\n\r\n          -  Eastern Cooperative Oncology Group Performance Status of 0 or 1\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Participants with CNS metastases as the only site of active disease (Participants with\r\n             controlled brain metastases; however, will be allowed to enroll)\r\n\r\n          -  Participants with active, known or suspected autoimmune disease\r\n\r\n          -  Participants with conditions requiring systemic treatment with either corticosteroids\r\n             (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days\r\n             of study treatment administration\r\n\r\n          -  Participants with a known history of testing positive for Human Immunodeficiency Virus\r\n             (HIV) or known Acquired Immunodeficiency Syndrome (AIDS)\r\n\r\n          -  Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior\r\n             anti-cancer therapy and initiation of study therapy\r\n\r\n        Other protocol defined inclusion/exclusion criteria could apply\r\n      ","sponsor":"Bristol-Myers Squibb","sponsor_type":"Industry","conditions":"Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: BMS-986253","description":"Specified dose on specified days"},{"intervention_type":"Biological","name":"Biological: Nivolumab","description":"Specified dose on specified days"},{"intervention_type":"Biological","name":"Biological: Ipilimumab","description":"Specified dose on specified days"},{"intervention_type":"Other","name":"Other: Placebo","description":"Specified dose on specified days"}],"outcomes":[{"outcome_type":"secondary","measure":"Incidence of clinically significant changes in clinical laboratory results: Hematology tests","time_frame":"Approximately 5 years","description":"Part 2"},{"outcome_type":"secondary","measure":"Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests","time_frame":"Approximately 5 years","description":"Part 2"},{"outcome_type":"secondary","measure":"Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests","time_frame":"Approximately 5 years","description":"Part 2"},{"outcome_type":"secondary","measure":"Incidence of AEs leading to discontinuation","time_frame":"Approximately 5 years","description":"Part 2"},{"outcome_type":"secondary","measure":"Incidence of death","time_frame":"Approximately 5 years","description":"Part 2"},{"outcome_type":"primary","measure":"Incidence of adverse events (AE)","time_frame":"Approximately 5 years","description":"Part 1"},{"outcome_type":"primary","measure":"Incidence of serious adverse events (SAE)","time_frame":"Approximately 5 years","description":"Part 1"},{"outcome_type":"primary","measure":"Incidence of AEs meeting protocol-defined dose limiting toxicities (DLT) criteria","time_frame":"Approximately 5 years","description":"Part 1"},{"outcome_type":"primary","measure":"Incidence of AEs leading to discontinuation","time_frame":"Approximately 5 years","description":"Part 1"},{"outcome_type":"primary","measure":"Incidence of deaths","time_frame":"Approximately 5 years","description":"Part 1"},{"outcome_type":"primary","measure":"Incidence of clinically significant changes in clinical laboratory results: Hematology tests","time_frame":"Approximately 5 years","description":"Part 1"},{"outcome_type":"primary","measure":"Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests","time_frame":"Approximately 5 years","description":"Part 1"},{"outcome_type":"primary","measure":"Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests","time_frame":"Approximately 5 years","description":"Part 1"},{"outcome_type":"primary","measure":"Progression-free survival (PFS) hazard ratio based on Blinded independent central review (BICR) assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1","time_frame":"Approximately 5 years","description":"Part 2, participants with advanced melanoma, selected by baseline serum interleukin-8 (IL-8) level using RECIST v1.1"},{"outcome_type":"secondary","measure":"Objective response rate (ORR) based on Blinded independent central review (BICR) assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1","time_frame":"Approximately 5 years","description":"Part 1 and Part 2"},{"outcome_type":"secondary","measure":"Median duration of response (mDOR) per response evaluation criteria in solid tumors (RECIST) v1.1","time_frame":"Approximately 5 years","description":"Part 1"},{"outcome_type":"secondary","measure":"Incidence of anti-drug antibody (ADA) to BMS-986253","time_frame":"Approximately 5 years","description":"Part 1 and Part 2"},{"outcome_type":"secondary","measure":"Serum biomarker concentration","time_frame":"Approximately 5 years","description":"Part 1"},{"outcome_type":"secondary","measure":"Maximum observed serum concentration (Cmax)","time_frame":"Approximately 5 years","description":"Part 1 and Part 2"},{"outcome_type":"secondary","measure":"Time of maximum observed serum concentration (Tmax)","time_frame":"Approximately 5 years","description":"Part 1 and Part 2"},{"outcome_type":"secondary","measure":"Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]","time_frame":"Approximately 5 years","description":"Part 1 and Part 2"},{"outcome_type":"secondary","measure":"Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]","time_frame":"Approximately 5 years","description":"Part 1 and Part 2"},{"outcome_type":"secondary","measure":"Observed serum concentration at the end of a dosing interval (CTAU)","time_frame":"Approximately 5 years","description":"Part 1 and Part 2"},{"outcome_type":"secondary","measure":"Trough observed serum concentration at the end of the dosing interval (CTROUGH)","time_frame":"Approximately 5 years","description":"Part 1 and Part 2"},{"outcome_type":"secondary","measure":"Progression-free survival (PFS) hazard ratio based on Blinded independent central review (BICR) assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1","time_frame":"Approximately 5 years","description":"Part 2, participants with advanced melanoma, using RECIST v1.1 (regardless of baseline serum IL-8 levels)"},{"outcome_type":"secondary","measure":"Overall Survival (OS)","time_frame":"Approximately 5 years","description":"Part 2"},{"outcome_type":"secondary","measure":"Incidence of AEs","time_frame":"Approximately 5 years","description":"Part 2"},{"outcome_type":"secondary","measure":"Incidence of SAEs","time_frame":"Approximately 5 years","description":"Part 2"}]}
{"nct_id":"NCT03664492","start_date":"2018-02-10","phase":"N/A","enrollment":128,"brief_title":"Talking About Weight With Families: An Innovative Educational Strategy","official_title":"Talking About Weight With Families: An Innovative Educational Strategy","primary_completion_date":"2018-12-15","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-12-15","last_update":"2021-02-05","description":"Tools are limited to help health care professionals and parents talk about weight-related issues with their paediatric patients and children, respectively. The investigators have developed two whiteboard videos: 1) to aim to help health care professionals talk about weight-related issues with paediatric patients and their families, and 2) to aim to help parents feel more comfortable talking about weight with their children. This study aims to evaluate the videos using pre and post questionnaires. With the questionnaires, the investigators want to evaluate the content, the quality, the usability of the video and to measure how helpful the video were for health care professionals and parents.","other_id":"1000055748","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","intervention_model_description":"The recruited group of health care professionals/parents will answer a pre-questionnaire, then watch an educational video, then answer a post-questionnaire. If they agree, these participants will be asked to complete a third questionnaire (retention questionnaire) 4 to 6 months later.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Health care professionals and trainees\r\n\r\n          -  Parents with a child under 18 years old\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Inability to speak and read English fluently\r\n\r\n          -  Moderate to severe cognitive impairment\r\n      ","sponsor":"The Hospital for Sick Children","sponsor_type":"Other","conditions":"Childhood Obesity","interventions":[{"intervention_type":"Other","name":"Other: Educational whiteboard video","description":"Participants will be prompted to complete pre-questionnaire, followed by access to the video, with a prompt to complete the post questionnaire after. If they agree, they will receive 4 to 6 months later, a third questionnaire to complete. For those without access to the internet, we will offer to them view the video at the SickKids at their convenience."}],"outcomes":[{"outcome_type":"primary","measure":"Post Questionnaire - Parents (4-6 mo) - Confidence in ability to raise the issue about weight","time_frame":"4 - 6 months post education video","description":"Change in confidence level in their ability to raise the issue/talk about weight with their children using a scale from 0-100."},{"outcome_type":"primary","measure":"Post Questionnaire - Parents (4-6 mo) - Level of agreement in statements related to behvaiour change","time_frame":"4 - 6 months post education video","description":"Level of agreement in statements related to behaviour change post education using in a 5 point likert scale"},{"outcome_type":"primary","measure":"Health Care Professional Post Questionnaire - Confidence in initiating conversation about overweight","time_frame":"immediately post education video","description":"Change in confidence level for initiating a conversation with a family or pediatric patient that meets criteria for overweight or obesity using a scale from 0-100."},{"outcome_type":"primary","measure":"Health Care Professional Post Questionnaire - Confidence in initiating conversation about underweight","time_frame":"immediately post education video","description":"Change in confidence level for initiating a conversation with a family or pediatric patient that meets criteria for underweight using a scale from 0-100."},{"outcome_type":"primary","measure":"Health Care Professional Questionnaire (4-6 Months Post) Confidence in initiating conversation about overweight","time_frame":"4 - 6 months post education video","description":"Change in confidence level for initiating a conversation with a family or pediatric patient that meets criteria for underweight using a scale from 0-100."},{"outcome_type":"primary","measure":"Health Care Professional Questionnaire (4-6 Months Post) Confidence in initiating conversation about underweight","time_frame":"4 - 6 months post education video","description":"Change in confidence level for initiating a conversation with a family or pediatric patient that meets criteria for overweight or obesity using a scale from 0-100."}]}
{"nct_id":"NCT03425942","start_date":"2018-02-09","phase":"N/A","enrollment":54,"brief_title":"Internet Administered CBT for Insomnia Comorbid With Chronic Pain","official_title":"Internet Administered CBT for Insomnia Comorbid With Chronic Pain Compared to Applied Relaxation Techniques - A Randomized Controlled Trial","primary_completion_date":"2019-05-07","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-05-14","last_update":"2021-01-11","description":"Cognitive behavioural therapy (CBT), that is designed to be short, concise and user friendly is compared to applied relaxation techniques as treatment for insomnia comorbid with chronic pain. Both treatments are administered via internet and participants are randomized to ether treatment arm.","other_id":"LIU-002","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Insomnia severity index (ISI) score > 14\r\n\r\n          -  Chronic pain\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Shift worker or employed as a driver, operator of dangerous equipment and such\r\n\r\n          -  Sleep apnea, restless legs syndrome, narcolepsy, Myalgic Encephalomyelitis/Chronic\r\n             Fatigue Syndrome (ME/CFS)\r\n\r\n          -  Bipolar disorder, psychotic disorders, ongoing substance abuse\r\n\r\n          -  Having received CBT for insomnia during the latest year\r\n\r\n          -  Pregnancy\r\n\r\n          -  Severe somatic disorder (such as ongoing cancer, severe neurological condition,\r\n             insufficiently treated cardiac condition)\r\n\r\n          -  Impaired movement to such a degree that going to bed or getting out of bed requires\r\n             assistance\r\n\r\n          -  Not being able read or wright in Swedish\r\n\r\n          -  Not having an internet-connected computer, cellular phone or tablet\r\n      ","sponsor":"Linkoeping University","sponsor_type":"Other","conditions":"Insomnia Due to Medical Condition|Chronic Pain","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Internet Cognitive Behavioral Therapy for insomnia (ICBT-i)","description":"This intervention lasts for five weeks. The intervention is internet-based and mainly consists of the most potent CBT technics i.e. sleep restriction and stimulus control. Weekly feedback is provided by master students supervised by clinical psychologists."},{"intervention_type":"Behavioral","name":"Behavioral: Internet Applied Relaxation Techniques (IART-i)","description":"This intervention lasts for five weeks. The intervention is internet-based and consists of different common applied relaxation exercises and treatments. Weekly feedback is provided by master students supervised by clinical psychologists."}],"outcomes":[{"outcome_type":"primary","measure":"Insomnia Severity Index (ISI)","time_frame":"Change from baseline insomnia severity (ISI) at 6 months","description":"Measures degree of insomnia. Range 0-28 where a higher value indicates worse sleep."},{"outcome_type":"secondary","measure":"Sleep diary","time_frame":"Daily during treatment (five weeks).","description":"Basis for sleep latency, total sleep time, wake time after sleep onset and sleep efficiency."},{"outcome_type":"secondary","measure":"The Karolinska Sleepiness Scale (KSS)","time_frame":"Change from baseline sleepiness (KSS) at 5 weeks","description":"Measures sleepiness on a single item numeric rating scale. Range 1-9, where a higher value indicates more sleepiness."},{"outcome_type":"secondary","measure":"Patient Health Questionnaire (PHQ-9)","time_frame":"Change from baseline health (PHQ-9) at 6 months","description":"Measures depressive symptoms. Range 0-27, where a higher value indicates more depressive symptoms."},{"outcome_type":"secondary","measure":"Generalised Anxiety Disorder 7-item scale (GAD-7)","time_frame":"Change from baseline anxiety (GAD-7) at 6 months","description":"Measures anxiety symptoms. Range 0-21 where a higher value indicates more anxiety."},{"outcome_type":"secondary","measure":"Pain intensity (NRS)","time_frame":"Change from baseline pain intensity (NRS) at 6 months","description":"Eleven stepped numeric rating scale (NRS) for average pain last seven days. Higher values indicate higher pain intensity."},{"outcome_type":"secondary","measure":"Pain Disability Index (PDI)","time_frame":"Change from baseline disability (PDI) at 6 months","description":"Quantifying pain related disability. Range 0-70 where a higher value indicates more disability."},{"outcome_type":"other","measure":"Pain spreading (PS)","time_frame":"Change from baseline pain spreading (PS) at 6 months","description":"Number of anatomical regions with pain out of 36 anatomical areas."},{"outcome_type":"other","measure":"Negative Effects Questionnaire (NEQ)","time_frame":"at 5 weeks and at 6 months","description":"Monitoring and Reporting Adverse and Unwanted Events (32 items). Range 0-128 where a higher value indicates more adverse events."},{"outcome_type":"other","measure":"Patient Health Questionnaire (PHQ-4)","time_frame":"Change from baseline health (PHQ-4) at 5 weeks","description":"Measures depressive symptoms and anxiety. Range 0-12 where a higher value indicates more depressive or anxiety symptoms."}]}
{"nct_id":"NCT03426956","start_date":"2018-02-08","phase":"N/A","enrollment":10,"brief_title":"Glucose Absorption and Gut Hormone Secretion After Gastric Bypass","official_title":"Impact of Canaglifloxin on Gut Hormone Secretion After Gastric Bypass","primary_completion_date":"2019-05-01","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-05-01","last_update":"2018-02-09","description":"To investigate the impact of canagliflozin on secretion of gut hormones, in particular glucagon-like peptide 1 (GLP-1) in gastric bypass operated patients.","other_id":"CM-CANA-18","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Basic Science","masking_description":"Single","intervention_model_description":"10 gastric bypass patients","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Uncomplicated gastric bypass surgery performed minimum 12 months prior to study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Type 1 or 2 diabetes mellitus prior to or after gastric bypass surgery\r\n\r\n          -  Pregnancy or breastfeeding\r\n\r\n          -  Haemoglobin levels below 6,5 mM\r\n      ","sponsor":"Hvidovre University Hospital","sponsor_type":"Other","conditions":"Overweight","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Glucose","description":"Ingestion of glucose (50 g) dissolved in 200 ml water."},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Glucose + Canagliflozin","description":"Ingestion of glucose (50 g) dissolved in 200 ml water combined with the SGLT-1/SGLT-2 inhibitor canagliflozin."}],"outcomes":[{"outcome_type":"primary","measure":"Difference in GLP-1 secretion (evaluated by iAUC).","time_frame":"0-240 min following glucose ingestion","description":"Comparison of the GLP-1 responses (evaluated by iAUC) between the two test days."},{"outcome_type":"secondary","measure":"Difference in glucose responses between the two test days.","time_frame":"0-240 min following glucose ingestion"},{"outcome_type":"secondary","measure":"Difference in insulin responses between the two test days.","time_frame":"0-240 min following glucose ingestion"},{"outcome_type":"secondary","measure":"Difference in C-peptide responses between the two test days.","time_frame":"0-240 min following glucose ingestion"},{"outcome_type":"secondary","measure":"Difference in Gastric Inhibitory Peptide (GIP) responses (evaluated by iAUC) between the two test days.","time_frame":"0-240 min following glucose ingestion"},{"outcome_type":"secondary","measure":"Difference in peptide YY (PYY) responses (evaluated by iAUC) between the two test days.","time_frame":"0-240 min following carbohydrate ingestion"},{"outcome_type":"secondary","measure":"Difference in glucagon responses (evaluated by iAUC) between the two test days.","time_frame":"0-240 min following glucose ingestion"},{"outcome_type":"secondary","measure":"Difference in oxyntomodulin responses (evaluated by iAUC) between the two test days.","time_frame":"0-240 min following carbohydrate ingestion"},{"outcome_type":"secondary","measure":"Difference in cholecystokinin (CCK) responses (evaluated by iAUC) between the two test days.","time_frame":"0-240 min following glucose ingestion"},{"outcome_type":"secondary","measure":"Difference in bile acid responses (evaluated by iAUC) between the two test days.","time_frame":"0-240 min following glucose ingestion"}]}
{"nct_id":"NCT03451110","start_date":"2018-02-05","phase":"Phase 1","enrollment":50,"brief_title":"Study to Assess the Pharmacokinetic Drug-Drug Interactions of Lemborexant When Coadministered With an Oral Contraceptive, Famotidine, or Fluconazole in Healthy Subjects","official_title":"A 3-Part, Open-label Study to Assess the Pharmacokinetic Drug-Drug Interactions of Lemborexant When Coadministered With an Oral Contraceptive, Famotidine, or Fluconazole in Healthy Subjects","primary_completion_date":"2018-03-23","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-03-23","last_update":"2018-09-06","description":"This study will be conducted to evaluate the effect of lemborexant 10 milligrams (mg) (at steady state) on the pharmacokinetics (PK) of a single-dose combined oral contraceptive, Loestrin 1.5/30 (containing 0.030 mg of ethinyl estradiol and 1.5 mg of norethindrone), and to evaluate the effect of fluconazole 200 mg (at steady state) and a single dose of famotidine 40 mg (an H2 blocker) on the PK of a single oral dose of lemborexant 10 mg.","other_id":"E2006-A001-012","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Inclusion Criteria for All Participants (Part 1 - Oral Contraceptive; Part 2 - Famotidine;\r\n        Part 3 - Fluconazole)\r\n\r\n        Participants who meet all of the following inclusion criteria will be eligible for\r\n        participation in the study:\r\n\r\n          -  Body mass index >18 and 32 kilograms per meters squared at Screening\r\n\r\n          -  Are willing and able to comply with all aspects of the protocol\r\n\r\n          -  Provide written informed consent\r\n\r\n        Additional Inclusion Criteria for Part 1 - Oral Contraceptive\r\n\r\n          -  Healthy female participants, ages 18 to 44 years old (inclusive) at Screening\r\n\r\n          -  Must not be taking any form of hormonal contraceptives, including hormonal\r\n             intra-uterine device, for at least 8 weeks prior to dosing\r\n\r\n        Additional Inclusion Criteria (Part 2 - Famotidine; Part 3 - Fluconazole)\r\n\r\n        -Healthy male or female, age 18 years and 55 years old at the time of informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Known contraindication to Loestrin (only for Part 1), to Famotidine (only for Part 2),\r\n             or to Fluconazole (only for Part 3)\r\n\r\n          -  Females who are breastfeeding or pregnant at Screening or Baseline.\r\n\r\n          -  Females of childbearing potential. NOTE: All females will be considered to be of\r\n             childbearing potential unless they are postmenopausal (amenorrheic for at least 12\r\n             consecutive months, in the appropriate age group, and without other known or suspected\r\n             cause) or have been sterilized surgically (i.e., bilateral tubal ligation, total\r\n             hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before\r\n             dosing).\r\n\r\n          -  Clinically significant illness that requires medical treatment within 8 weeks or a\r\n             clinically significant infection that requires medical treatment within 4 weeks of\r\n             dosing\r\n\r\n          -  Presence of significant illness that requires treatment or may influence the study\r\n             assessments (e.g. psychiatric disorders, disorders of the gastrointestinal tract,\r\n             liver, kidney, respiratory system, endocrine system, hematological system,\r\n             neurological system, cardiovascular system, or a congenital abnormality)\r\n\r\n          -  Any history of abdominal surgery that may affect PK profiles of lemborexant (eg,\r\n             hepatectomy, nephrectomy, digestive organ resection) at Screening\r\n\r\n          -  Any other clinically abnormal symptom or organ impairment found by medical history,\r\n             physical examinations, vital signs, electrocardiogram (ECG) finding, or laboratory\r\n             test results that requires medical treatment at Screening or Baseline\r\n\r\n          -  A prolonged QT/corrected QT (QTc) interval (QTc >450 milliseconds) demonstrated on ECG\r\n             at Screening or Baseline\r\n\r\n          -  Persistent systolic blood pressure (BP) >160 millimeters of mercury (mmHg) or\r\n             diastolic BP >100 mmHg at Screening or Baseline (based on BP measured on at least 3\r\n             occasions over 2 weeks)\r\n\r\n          -  Persistent heart rate (HR) of <50 beats per minute (beats/min) or >90 beats/min at\r\n             Screening or Baseline (based on HR measured on at least 3 occasions over 2 weeks)\r\n\r\n          -  Known history of clinically significant drug allergy at Screening or Baseline\r\n\r\n          -  Known history of food allergies or presently experiencing significant seasonal or\r\n             perennial allergy at Screening or Baseline\r\n\r\n          -  Known to be human immunodeficiency virus positive\r\n\r\n          -  Active viral hepatitis (B or C) as demonstrated by positive serology at Screening\r\n\r\n          -  History of drug or alcohol dependency or abuse within the 2 years before Screening\r\n\r\n          -  Participants who smoke or have used tobacco or nicotine-containing products within 4\r\n             weeks before dosing\r\n\r\n          -  Any suicidal ideation with intent with or without a plan at Screening or within 6\r\n             months of Screening (ie, for Part 1 answering \"Yes\" to questions 4 or 5 on the\r\n             Suicidal Ideation section of the Columbia-Suicide Severity Rating Scale) or any\r\n             suicidal behavior in the past 10 years.\r\n\r\n          -  Currently enrolled in another clinical trial or used any investigational drug or\r\n             device within 30 days (or 5 half-lives, whichever is longer) preceding informed\r\n             consent\r\n\r\n          -  Engagement in strenuous exercise within 2 weeks before check-in (e.g., marathon\r\n             runners, weight lifters)\r\n\r\n          -  Intake of caffeinated beverages or caffeinated food within 72 hours before dosing and\r\n             during the course of the study\r\n\r\n          -  Intake of food supplements (including herbal preparations), foods, or beverages that\r\n             may affect cytochrome P4503A4 enzyme (e.g., alcohol, grapefruit, grapefruit juice,\r\n             grapefruit-containing beverages, apple or orange juice, vegetables from the mustard\r\n             green family [e.g., kale, broccoli, watercress, collard greens, kohlrabi, Brussels\r\n             sprouts, mustard], and charbroiled meats) within 1 week before dosing\r\n\r\n          -  Intake of herbal preparations containing St. John's Wort within 4 weeks before dosing\r\n\r\n          -  Intake of prescription or over-the-counter medications within 14 days (or 5\r\n             half-lives, whichever is longer) before dosing unless the Principal Investigator and\r\n             medical monitor consider that they do not compromise participant safety or study\r\n             assessments\r\n\r\n          -  A positive urine drug test, a positive breathalyzer alcohol test, or, if appropriate,\r\n             a positive serum pregnancy test\r\n      ","sponsor":"Eisai Inc.","sponsor_type":"Industry","conditions":"Healthy Subjects","interventions":[{"intervention_type":"Drug","name":"Drug: lemborexant","description":"oral tablet"},{"intervention_type":"Drug","name":"Drug: Loestrin","description":"oral tablet"},{"intervention_type":"Drug","name":"Drug: famotidine","description":"oral tablet"},{"intervention_type":"Drug","name":"Drug: fluconazole","description":"oral tablet"}],"outcomes":[{"outcome_type":"primary","measure":"Part 1 (Lemborexant plus Loestrin): Mean maximum observed concentration (Cmax) of lemborexant and metabolites","time_frame":"Blood samples for lemborexant and metabolite assessment will be obtained at predose and 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours postdose on Days 14 and 15."},{"outcome_type":"primary","measure":"Part 1 (Lemborexant plus Loestrin): Mean predose drug concentration (Cmin) of lemborexant and metabolites","time_frame":"Blood samples for lemborexant and metabolite assessment will be obtained at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours postdose on Days 14 and 15."},{"outcome_type":"primary","measure":"Part 1 (Lemborexant plus Loestrin): Mean time to reach maximum (peak) drug concentration following drug administration (Tmax) of lemborexant and metabolites","time_frame":"Blood samples for lemborexant and metabolite assessment will be obtained at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours postdose on Days 14 and 15."},{"outcome_type":"primary","measure":"Part 1 (Lemborexant plus Loestrin): Mean area under the concentration-time curve from zero time to 24 hours postdose (AUC[0-24h]) of lemborexant and metabolites","time_frame":"Blood samples for lemborexant and metabolite assessment will be obtained at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours postdose on Days 14 and 15."},{"outcome_type":"primary","measure":"Part 2 (Lemborexant plus Famotidine): Mean Cmax of lemborexant and metabolites","time_frame":"Blood samples for lemborexant and metabolite assessment will be obtained at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168, and 216 hours after dosing on Days 1 and 15."},{"outcome_type":"primary","measure":"Part 2 (Lemborexant plus Famotidine): Mean Tmax of lemborexant and metabolites","time_frame":"Blood samples for lemborexant and metabolite assessment will be obtained at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168, and 216 hours after dosing on Days 1 and 15."},{"outcome_type":"primary","measure":"Part 2 (Lemborexant plus Famotidine): Mean AUC(0-24h) of lemborexant and metabolites","time_frame":"Blood samples for lemborexant and metabolite assessment will be obtained at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168, and 216 hours after dosing on Days 1 and 15."},{"outcome_type":"primary","measure":"Part 2 (Lemborexant plus Famotidine): Mean AUC from zero time to 72 hours postdose (AUC[0-72h]) of lemborexant and metabolites","time_frame":"Blood samples for lemborexant and metabolite assessment will be obtained at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168, and 216 hours after dosing on Days 1 and 15."},{"outcome_type":"primary","measure":"Part 2 (Lemborexant plus Famotidine): Mean AUC from zero time to last measurable time (AUC[0-t]) of lemborexant and metabolites","time_frame":"Blood samples for lemborexant and metabolite assessment will be obtained at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168, and 216 hours after dosing on Days 1 and 15."},{"outcome_type":"primary","measure":"Part 2 (Lemborexant plus Famotidine): Mean AUC from zero time extrapolated to infinite time (AUC[0-inf]) of lemborexant and metabolites","time_frame":"Blood samples for lemborexant and metabolite assessment will be obtained at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168, and 216 hours after dosing on Days 1 and 15."},{"outcome_type":"primary","measure":"Part 2 (Lemborexant plus Famotidine): Mean terminal elimination half-life (t1/2) of lemborexant and metabolites following the last dose","time_frame":"Blood samples for lemborexant and metabolite assessment will be obtained at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168, and 216 hours after dosing on Days 1 and 15."},{"outcome_type":"primary","measure":"Part 3 (Lemborexant plus Fluconazole): Mean Cmax of lemborexant and metabolites","time_frame":"Blood samples for lemborexant and metabolite assessment will be obtained on Days 1 to 27.","description":"Day 1 at predose and at approximately 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose. At approximately 24, 48, and 72 (Days 2 to 4); 120 (Day 6); 168 (Day 8); 216 (Day 10) hours after the first dose. Day 15 at predose and at approximately 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the second dose. At approximately 24, 48, and 72 (Days 16 to 18); 120 (Day 20); 168 (Day 22); 216 (Day 24); 288 (Day 27) hours after the second dose."},{"outcome_type":"primary","measure":"Part 3 (Lemborexant plus Fluconazole): Mean Tmax of lemborexant and metabolites","time_frame":"Blood samples for lemborexant and metabolite assessment will be obtained on Days 1 to 27.","description":"Day 1 at predose and at approximately 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose. At approximately 24, 48, and 72 (Days 2 to 4); 120 (Day 6); 168 (Day 8); 216 (Day 10) hours after the first dose. Day 15 at predose and at approximately 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the second dose. At approximately 24, 48, and 72 (Days 16 to 18); 120 (Day 20); 168 (Day 22); 216 (Day 24); 288 (Day 27) hours after the second dose."},{"outcome_type":"primary","measure":"Part 3 (Lemborexant plus Fluconazole): Mean AUC(0-24h) of lemborexant and metabolites","time_frame":"Blood samples for lemborexant and metabolite assessment will be obtained on Days 1 to 16.","description":"Day 1 at predose and at approximately 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose. At approximately 24 (Day 2) hours after the first dose. Day 15 at predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the second dose. At approximately 24 (Day 16) hours after the second dose."},{"outcome_type":"primary","measure":"Part 3 (Lemborexant plus Fluconazole): Mean AUC(0-72h) of lemborexant and metabolites","time_frame":"Blood samples for lemborexant and metabolite assessment will be obtained on Days 1 to 18.","description":"Day 1 at predose and at approximately 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose. At approximately 24, 48, and 72 (Days 2 to 4) hours after the first dose. Day 15 at predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the second dose. At approximately 24, 48, 72 hours (Days 16 to 18 after the second dose)."},{"outcome_type":"primary","measure":"Part 3 (Lemborexant plus Fluconazole): Mean AUC(0-t) of lemborexant and metabolites","time_frame":"Blood samples for lemborexant and metabolite assessment will be obtained on Days 1 to 27.","description":"Day 1 at predose and at approximately 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose. At approximately 24, 48, and 72 (Days 2 to 4); 120 (Day 6); 168 (Day 8); 216 (Day 10) hours after the first dose. Day 15 at predose and at approximately 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the second dose. At approximately 24, 48, and 72 (Days 16 to 18); 120 (Day 20); 168 (Day 22); 216 (Day 24); 288 (Day 27) hours after the second dose."},{"outcome_type":"primary","measure":"Part 3 (Lemborexant plus Fluconazole): Mean AUC(0-inf) of lemborexant and metabolites","time_frame":"Blood samples for lemborexant and metabolite assessment will be obtained on Days 1 to 27.","description":"Day 1 at predose and at approximately 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose. At approximately 24, 48, and 72 (Days 2 to 4); 120 (Day 6); 168 (Day 8); 216 (Day 10) hours after the first dose. Day 15 at predose and at approximately 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the second dose. At approximately 24, 48, and 72 (Days 16 to 18); 120 (Day 20); 168 (Day 22); 216 (Day 24); 288 (Day 27) hours after the second dose."},{"outcome_type":"primary","measure":"Part 3 (Lemborexant plus Fluconazole): Mean t1/2 of lemborexant and metabolites following last dose","time_frame":"Blood samples for lemborexant and metabolite assessment will be obtained on Days 1 to 27.","description":"Day 1 at predose and at approximately 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose. At approximately 24, 48, and 72 (Days 2 to 4); 120 (Day 6); 168 (Day 8); 216 (Day 10) hours after the first dose. Day 15 at predose and at approximately 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the second dose. At approximately 24, 48, and 72 (Days 16 to 18); 120 (Day 20); 168 (Day 22); 216 (Day 24); 288 (Day 27) hours after the second dose."}]}
{"nct_id":"NCT03643302","start_date":"2018-02-01","enrollment":189,"brief_title":"Airway Clearance and Bronchoalveolar Lavage for Bronchiectasis Patients With Exacerbation","official_title":"Clinical Efficacy and Safety of Tran-bronchoscopy Airway Clearance and Bronchoalveolar Lavage in the Treatment of Moderate to Severe Bronchiectasis With Acute Exacerbation","primary_completion_date":"2019-02-28","study_type":"Observational","rec_status":"Completed","completion_date":"2019-03-18","last_update":"2020-10-08","description":"No study have evaluated the efficacy and safety of airway clearance therapy (ACT) and bronchoalveolar lavage (BAL) under bronchoscope for bronchiectasis. This study aimed to evaluate the clinical efficacy and safety of tran-bronchoscopy airway clearance and bronchoalveolar lavage in the treatment of moderate to severe bronchiectasis with acute exacerbation:A randomized, prospective cohort study.","other_id":"20180717","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":80,"population":"Patients with bronchiectasis being suffering an acute exacerbation of this disease.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Willing to join in and sign the informed consent form;\r\n\r\n          -  The diagnosis of bronchiectasis need reference to the definition of \"European\r\n             Respiratory Society guidelines for the management of adult bronchiectasis.\" published\r\n             by the european respiratory journal in 2017, defined by the presence of both permanent\r\n             bronchial dilatation on computed tomography (CT) scanning and the clinical syndrome of\r\n             cough, sputum production and/or recurrent respiratory infections;\r\n\r\n          -  Pulmonary exacerbation in patients with bronchiectasis was required to meet three or\r\n             more of the following key symptoms for at least 48h: Cough; Sputum volume and/or\r\n             consistency; Sputum purulence; Breathlessness and/or exercise tolerance; Fatigue\r\n             and/or malaise; Haemoptysis, and a clinician determines that a change in\r\n             bronchiectasis treatment is required;\r\n\r\n          -  According to the researchers, the subjects were willing and able to follow the\r\n             protocol and were able to tolerate bronchoscopy;\r\n\r\n          -  Patients with good compliance: the subject must be willing to follow the test plan\r\n             requirements in the research center to complete all the assessment of the visit.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnant or lactating women;\r\n\r\n          -  Hypogammaglobulinemia or other autoimmune diseases;\r\n\r\n          -  Clinical diagnosis of ABPA;\r\n\r\n          -  Non tuberculosis mycobacteria positive 2 years before;\r\n\r\n          -  Allergies or allergic to a variety of drugs;\r\n\r\n          -  Poor compliance or can not cooperate judged by doctors;\r\n\r\n          -  Participated in other clinical trials for nearly three months;\r\n\r\n          -  The researchers considered that the subject had other circumstances that were unfit to\r\n             attend;\r\n\r\n          -  Suffering from a significant disease or condition outside of bronchiectasis, as judged\r\n             by the researchers, may lead to subjects at risk due to participate in the study,or\r\n             the disease that have an impact on the research result and the ability of subjects to\r\n             participate in this study;\r\n\r\n          -  Bronchoscopy contraindication;\r\n\r\n          -  Patients with heart, liver and kidney, nervous system, endocrine and other systemic\r\n             diseases, may not be able to adhere to the completion of the study, or will affect the\r\n             research process;\r\n\r\n          -  Patients who refused to sign informed consent after targeted explanation.\r\n      ","sponsor":"Shanghai Pulmonary Hospital, Shanghai, China","sponsor_type":"Other","conditions":"Bronchiectasis Adult","interventions":[{"intervention_type":"Device","name":"Device: Version BF-1T26 electronic bronchoscope","description":"Interventions involving the therapy of airway clearance and bronchoalveolar lavage by Version BF-1T26 electronic bronchoscope"}],"outcomes":[{"outcome_type":"primary","measure":"Time to the first acute exacerbation after treatment","time_frame":"3 month","description":"The median time to first acute exacerbation after discharge.We used GraphPad Prism 6.0 Kaplan-Meier survival curve and the log-rank test to compare the differences of the primary outcome between both groups"},{"outcome_type":"secondary","measure":"The changes of mMRC score before and after treatment","time_frame":"7 days","description":"Modified Medical Research Centre"},{"outcome_type":"secondary","measure":"The changes of CAT score before and after treatment","time_frame":"7 days","description":"COPD Assessment Test"},{"outcome_type":"secondary","measure":"The changes of SGRQ before and after treatment","time_frame":"7 days","description":"St. George respiratory questionnaire"},{"outcome_type":"secondary","measure":"The changes of LCQ before and after treatment","time_frame":"7days","description":"Leicester Cough Questionnaire"},{"outcome_type":"secondary","measure":"The changes of 6MWD before and after treatment","time_frame":"1 days","description":"6 Minute Walking Distance"}]}
{"nct_id":"NCT04643236","start_date":"2018-02-01","phase":"N/A","enrollment":50,"brief_title":"Increased Knowledge Improve Oral Hygiene In Patients With Gingivitis","official_title":"Increased Knowledge About The Pathogenesis Of Periodontal Disease Improve Oral Hygiene In Patients With Gingivitis-A Blinded Randomised Controlled Clinical Study","primary_completion_date":"2019-04-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-11-01","last_update":"2020-11-25","description":"Proper plaque control is essential for to maintain oral and general health therefore, improving patient motivation is crucial for to prevent oral diseases including periodontal diseases. The aim of this clinical trial is to evaluate the effect of periodontal health education session (PHES) including the pathogenesis and consequences of periodontal diseases on oral hygiene motivation in patients with gingivitis.","other_id":"2017/151","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","intervention_model_description":"A Single-Centre, Randomised, Parallel Design Controlled Clinical Study","sampling_method":"","gender":"All","minimum_age":22,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subjects diagnosed with gingivitis (no clinical attachment loss) and no previous\r\n             periodontal treatment,\r\n\r\n          -  non-smokers,\r\n\r\n          -  aged>22 years old and who have a university degree,\r\n\r\n          -  had a visible plaque level > 50%.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients having systemic conditions that could affect the healing process and prevent\r\n             the application of oral hygiene instructions,\r\n\r\n          -  Patients rehabilitated with teeth/implant supported prostheses,\r\n\r\n          -  Patients diagnosed with periodontitis,\r\n\r\n          -  Patients having defective restorations/active teeth related infection or ongoing\r\n             orthodontic treatment\r\n\r\n          -  Patients who had to be out of the city in a long time during the study period.\r\n      ","sponsor":"Abant Izzet Baysal University","sponsor_type":"Other","conditions":"Gingivitis","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Periodontal health education session","description":"This session comprised of a condensed version of motivational interviewing and a periodontal education view/point. First, patients were analysed in terms of expectations from periodontal treatment/oral hygiene practice, knowledge about periodontal diseases and its consequences, daily oral hygiene routine, awareness of the current periodontal status and the main reasons for not doing proper brushing and interproximal cleaning. The same researcher who did not included in the clinic process informed the patients about how periodontal diseases develops, its aetiology, symptoms, consequences and the relationship with the important systemic disorders verbally and via brochure as well. The importance of the patients' own efforts about daily cleaning of the mouth were emphasized. Finally oral hygiene instructions, including brushing and flossing, were demonstrated to each patient after nonsurgical periodontal treatment."},{"intervention_type":"Behavioral","name":"Behavioral: Oral hygiene motivation session","description":"Standard oral hygiene instructions, including brushing and flossing, were demonstrated to each patient after nonsurgical periodontal treatment."}],"outcomes":[{"outcome_type":"primary","measure":"Change in Rustogi Modified Navy Plaque index (RMNPI) scores","time_frame":"Measured at Baseline and at 1st-, at 3rd- and at 6th month after nonsurgical periodontal treatment.","description":"The facial/lingual surfaces of each teeth was divided in nine region and scored as 0: absence of plaque and 1: existence of plaque. The averages of the sum of those scores were evaluated per patient as total (A+B+C+D), gingival margin associated (A+B+C) and interproximal region associated plaque above the margin (D+F). Furthermore, the indicator of proper interproximal cleaning surface area (A+C+D+F) was also evaluated per patient.\r\nThe change in RMNPI scores between all time intervals were evaluated and compared between study groups."},{"outcome_type":"secondary","measure":"Change in Papillary bleeding index (PBI) scores","time_frame":"Measured at Baseline and at 1st-, at 3rd- and at 6th month after nonsurgical periodontal treatment.","description":"Each papilla region was scored and the mean of those scores were recorded as PBI per patient. Accordingly, 0: no bleeding; 1: a single isolated bleeding point; 2: several isolated bleeding points; 3: interdental triangle fills with blood soon after probing; 4: intense bleeding occurs immediately after probing through the gingival margin.\r\nThe change in PBI scores between all time intervals were evaluated and compared between the study groups."}]}
{"nct_id":"NCT03496727","start_date":"2018-02-01","enrollment":35,"brief_title":"Serratus Anterior Block for Video-assisted Thoracoscopic Surgery","official_title":"Analgesic Effectiveness of Serratus Anterior Block for Video-assisted Thoracoscopic Surgery","primary_completion_date":"2018-03-01","study_type":"Observational","rec_status":"Completed","completion_date":"2018-03-01","last_update":"2018-04-13","description":"Ultrasound-guided SAPB is a facial plane block which maintained analgesia with blockade of lateral branches of intercostal nerves at above or below serratus plane muscle. There are few cases and studies in the literature reporting successful analgesia provided by SAPB in VATS operations. The serratus plane block is used in our clinic for postoperative analgesia in VATS operations. The aim of this study was to evaluate the postoperative pain scores and use of analgesia in patients performed with the serratus plane block in VATS operations in a 1-year period.","other_id":"2018/01-29","observational_model":"Case-Control","time_perspective":"Retrospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":80,"population":"VATS ( Video-assisted thoracoscopy)","criteria":"\n        Inclusion Criteria:\r\n\r\n        VATS( Video-assisted thoracoscopy) operation\r\n\r\n        a.Serratus anterior plane block b.patient controlled analgesia\r\n\r\n        Exclusion Criteria:\r\n\r\n        missing data written consent\r\n      ","sponsor":"Kahramanmaras Sutcu Imam University","sponsor_type":"Other","conditions":"Pain, Postoperative","interventions":[{"intervention_type":"Procedure","name":"Procedure: Serratus anterior plane block","description":"Serratus anterior plane block+patient controlled analgesia"},{"intervention_type":"Procedure","name":"Procedure: Patient controlled analgesia","description":"Patient-controlled analgesia"}],"outcomes":[{"outcome_type":"primary","measure":"Postoperative analgesic consumption","time_frame":"up to 24 hour","description":"Postoperative analgesic consumption"},{"outcome_type":"secondary","measure":"Post-operative pain scores","time_frame":"up to 24 hour","description":"The patient's level of pain in the postoperative period will be evaluated by the use of a 100mm Visual Analogue Scale (VAS) 1.,6.,12.,24. hour"},{"outcome_type":"other","measure":"Complications","time_frame":"Postoperative 1 week","description":"Postoperative Complications"}]}
{"nct_id":"NCT02689843","start_date":"2018-02-01","phase":"Early Phase 1","enrollment":90,"brief_title":"Effects of Cyproterone Compound-spironolactone, Metformin and Pioglitazone on Inflammatory Markers in PCOS","official_title":"Effects of Treatment With Cyproterone Compound-spironolactone, Metformin and Pioglitazone on Serum Inflammatory Markers in Patients With Polycystic Ovary Syndrome (PCOS)","primary_completion_date":"2018-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-12-30","last_update":"2019-11-12","description":"The aim of this study is to evaluate the effects of three-month course of treatment modalities (Cyproterone compound-Spironolactone, Metformin and Pioglitazone) in patients with polycystic ovary syndrome (PCOS) on markers of inflammation [serum complement, homocysteine and high sensitive C-reactive protein (hs-CRP)] levels.","other_id":"CT-P-9145-4025","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":35,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age 18-35 years\r\n\r\n          -  Diagnosis of Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria 2003\r\n             (two out of three required):\r\n\r\n               1. Oligomenorrhea or anovulation\r\n\r\n               2. Clinical and/or biochemical signs of hyperandrogenism\r\n\r\n               3. Polycystic ovaries (by ultrasound)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Smoking\r\n\r\n          -  Pregnancy\r\n\r\n          -  Diabetes mellitus\r\n\r\n          -  Renal failure (serum creatinine >1.5)\r\n\r\n          -  Congenital adrenal hyperplasia\r\n\r\n          -  Hyper or hypothyroidism\r\n\r\n          -  Sex hormone therapy or antiandrogen therapy during the last three months\r\n\r\n          -  Unexplained serum alanin aminotransferase (ALT) elevation more than 2.5 times above\r\n             normal range\r\n\r\n          -  Any systemic or febrile illnesses\r\n\r\n          -  Use of glucocorticoid or anti-inflammatory drugs during the last three months\r\n\r\n          -  Androgen secreting tumor\r\n\r\n          -  Malignancy\r\n      ","sponsor":"Shiraz University of Medical Sciences","sponsor_type":"Other","conditions":"Polycystic Ovary Syndrome","interventions":[{"intervention_type":"Drug","name":"Drug: Cyproterone compound + Spironolactone","description":"Cyproterone compound (Cyproterone Acetate 2mg-Ethinyl estradiol 35mcg) 1 tablet daily + Spironolactone 50 mg twice daily"},{"intervention_type":"Drug","name":"Drug: Metformin","description":"Metformin 500mg three times daily"},{"intervention_type":"Drug","name":"Drug: Pioglitazone","description":"Pioglitazone 30mg once daily"}],"outcomes":[{"outcome_type":"primary","measure":"Serum C3 level","time_frame":"3 months","description":"Serum concentration of a component of complement cascade: C3"},{"outcome_type":"primary","measure":"Serum C4 level","time_frame":"3 months","description":"Serum concentration of a component of complement cascade: C4"},{"outcome_type":"primary","measure":"Serum high-sensitive CRP (C-reactive protein)","time_frame":"3 months","description":"Serum concentration of high-sensitive C-reactive protein (hs-CRP)"},{"outcome_type":"secondary","measure":"Serum total Testosterone level","time_frame":"3 months","description":"Serum concentration of total Testosterone"},{"outcome_type":"secondary","measure":"Serum free Testosterone level","time_frame":"3 months","description":"Serum concentration of free Testosterone"},{"outcome_type":"secondary","measure":"Serum Dehydroepiandrosterone sulfate (DHEAS) level","time_frame":"3 months","description":"Serum concentration of Dehydroepiandrosterone sulfate"},{"outcome_type":"secondary","measure":"Serum follicle stimulating hormone (FSH) level","time_frame":"3 months","description":"Serum concentration of follicle stimulating hormone"},{"outcome_type":"secondary","measure":"Serum luteinizing hormone (LH) level","time_frame":"3 months","description":"Serum concentration of luteinizing hormone"},{"outcome_type":"secondary","measure":"Fasting Blood Sugar (FBS)","time_frame":"3 months","description":"Fasting Blood Sugar"},{"outcome_type":"secondary","measure":"Fasting Serum Insulin level","time_frame":"3 months","description":"Serum concentration of insulin"},{"outcome_type":"secondary","measure":"Serum homocysteine level","time_frame":"3 months","description":"Serum concentration of homocysteine"},{"outcome_type":"secondary","measure":"Number of patients with adverse events","time_frame":"3 months","description":"Number of patients with adverse events"}]}
{"nct_id":"NCT03038256","start_date":"2018-01-31","phase":"Phase 2","enrollment":508,"brief_title":"Effect of Concurrent Capecitabine-based Long-term Radiotherapy Followed by XELOX Plus TME in Patients With High Risk Rectal Cancer: a Multi-centers, Randomized Controlled, Open-Label Trial","official_title":"Effect of Concurrent Capecitabine-based Long-term Radiotherapy Followed by 4 Cycles XELOX Pre- a Delayed TME Compared With 6 Cycles XELOX post-a Regular Timing TME in Patients With High Risk Rectal Cancer: a Multi-centers, Randomized, Open-Label Trial","primary_completion_date":"2020-06-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-12-01","last_update":"2020-05-19","description":"The purpose of this study was to evaluate the effect of concurrent capecitabine-based long-term radiotherapy followed by 4 cycles XELOX pre- a delayed TME compared with 6 cycles XELOX post- a Regular Timing TME in patients with high-risk rectal cancer defined by MRI.","other_id":"2016-12 EXPLORE","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age of 18-75 years;\r\n\r\n          2. Histologically confirmed adenocarcinoma;\r\n\r\n          3. The rectal adenocarcinoma 0-12cm from the anal margin on Magnetic resonance imaging\r\n             (MRI) and/or rigid sigmoidoscopy;\r\n\r\n          4. High risk of rectal cancer defined by high-resolution MRI: tumor invasion 5mm beyond\r\n             the muscularis propria, or extramural vascular invasion, or circumferential resection\r\n             margin unsafe, or the lower rectal cancer invades intersphincteric space, or rectal\r\n             cancer invades the adjacent structures.\r\n\r\n          5. Eastern Collaborative Oncology Group performance status score of 0 or 2\r\n\r\n          6. Able and willing to give informed consent to participate.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Received preoperative chemoradiotherapy for rectal cancer before the recruitment of\r\n             this study;\r\n\r\n          2. Have metastatic disease (including non-regional lymph nodes metastases or resectable\r\n             liver metastases);\r\n\r\n          3. Other malignancies, non-adenocarcinoma rectal malignancies or rectal malignancies on\r\n             the basis of inflammatory bowel disease;\r\n\r\n          4. Emergency surgery due to bowel obstruction, perforation, bleeding, etc.;\r\n\r\n          5. Abnormality of capecitabine absorption due to gastrointestinal disease e.g. short\r\n             bowel syndrome, inflammation bowel disease, et al.;\r\n\r\n          6. Unresectable concurrent intestinal lesions;\r\n\r\n          7. Concurrent severe infection\r\n\r\n          8. Cardiac Diseaseuncontrolled or symptomatic cardiac anginaor uncontrolled arrhythmias\r\n             and hypertension, or severe congestive heart failure grade II or more based on New\r\n             York Heart Association (NYHA); myocardial infarction within the past 12 months\r\n\r\n          9. Peripheral neuropathy more than grade 1 according to the National Cancer Institute\r\n             Common Terminology Criteria for Adverse Events (CTCAE; version 30)\r\n\r\n         10. Bone marrow, liver and kidney function are abnormal e.g., white blood cell  1.5  109\r\n             / L; platelet  100  109 / L; Haemoglobin  80 g/L; Bilirubin > 1.5 times the upper\r\n             limit; aspartate aminotransferase and alanine aminotransferase > 2.5 times the upper\r\n             limit; creatinine > 1.5 times the upper limit;\r\n\r\n         11. Pregnant or lactating women;\r\n\r\n         12. Life prediction less than 3 months, other severe diseases;\r\n\r\n         13. Contraindication to MRI; e.g. non-MRI compatible hip prosthesis, cardiac pacemaker;\r\n\r\n         14. Contraindication to standard chemotherapy including drug interactions and glomerular\r\n             filtration rate <50 mL/min at baseline;\r\n\r\n         15. Participators who had been recruited by other clinical trial within three months.\r\n      ","sponsor":"Peking University People's Hospital","sponsor_type":"Other","conditions":"Rectal Cancer|Pathological Complete Response|Disease Free Survival","interventions":[{"intervention_type":"Drug","name":"Drug: concurrent capecitabine-based long-term radiotherapy followed by 4 cycles XELOX and a delayed TME","description":"concurrent capecitabine-based long-term radiotherapy: capecitabine 825mg/m2,bid,d1-5, q week with Radiation treatment. Radiation treatment was given at 18 Gy per day, 5 days per week for 5-6 weeks, after a 45 Gy radiation dose in 25 fractions to the pelvis, a boost dose of 54 Gy in 3 fractions to the tumor bed or concurrent boosted.\r\nXELOX:\r\nOxaliplatin: 130mg/m2,IV,d1; Capecitabine: 1000mg/m2,bid,d1-14; repeated every 3 weeks\r\nSurgery Procedure:\r\nTotal Mesorectal Excision"},{"intervention_type":"Drug","name":"Drug: concurrent capecitabine-based long-term radiotherapy followed by a Regular TME and 6 Cycles XELOX","description":"concurrent capecitabine-based long-term radiotherapy: capecitabine 825mg/m2,bid,d1-5, q week with Radiation treatment. Radiation treatment was given at 18 Gy per day, 5 days per week for 5-6 weeks, after a 45 Gy radiation dose in 25 fractions to the pelvis, a boost dose of 54 Gy in 3 fractions to the tumor bed or concurrent boosted.\r\nXELOX:\r\nOxaliplatin: 130mg/m2,IV,d1; Capecitabine: 1000mg/m2,bid,d1-14; repeated every 3 weeks\r\nSurgery Procedure:\r\nTotal Mesorectal Excision"}],"outcomes":[{"outcome_type":"primary","measure":"Pathological complete response rate","time_frame":"up to 30days after total mesorectal excision","description":"Pathological complete response (pCR) rate between control and intervention arm"},{"outcome_type":"secondary","measure":"Disease Free Survival","time_frame":"3-year","description":"Disease Free Survival was defined as the time from the date of surgery to the date of the local recurrence, and/or distant disease, or tumor-related death."},{"outcome_type":"secondary","measure":"R0 of total mesorectal excision rate","time_frame":"up to 30days after total mesorectal excision","description":"Overall R0 of total mesorectal excision rate between the control and intervention arm"},{"outcome_type":"secondary","measure":"Surgery morbidity","time_frame":"30 days and 12-months","description":"Surgical morbidity reported according to Clavien-Dindo classification"},{"outcome_type":"secondary","measure":"quality of surgery","time_frame":"Time of surgery","description":"Quality of surgery determined using the mesorectal grading system"}]}
{"nct_id":"NCT03390699","start_date":"2018-01-31","phase":"N/A","enrollment":15,"brief_title":"Microbial Profile Among Patients Before and After Partial Maxillectomy","official_title":"The Microbial Profile Among Patients Before and After Partial Maxillectomy","primary_completion_date":"2018-01-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2018-03-31","last_update":"2018-01-04","description":"Patients after maxillecotmy develop gum disease and teeth decay often. these two diseases are caused by bacteria. In addition, these patients may have oral infections such as candida . The therapeutic approach now days to these diseases (dental decay and periodontal disease) can change following the results of the study. the purpose of the study is to examine whether the connection between the oral cavity and anatomical structures exposed by maxillectomy procedure causes a change in the level of microbes examined. To the best of our knowledge, there are not yet studies examined the clinical and microbiological changes in the oral cavity before and after surgery.","other_id":"0259-17-RMB CTIL","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","intervention_model_description":"Microbial profile among patients before partial maxillectomy","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. signed Consent form\r\n\r\n          2. Patients who are supposed to undergo Maxilla removal without closing the defect using\r\n             a tissue implant and will need to complete the missing area by an obturator.\r\n\r\n          3. Men and women aged 18 and over\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Allergy to substances from which the obturator is made.\r\n\r\n          2. Pregnant women\r\n\r\n          3. Taking antibiotic drugs that affect bacterial flora 4 weeks before taking the saliva\r\n             sample.\r\n\r\n          4. Psychiatric problem\r\n      ","sponsor":"Rambam Health Care Campus","sponsor_type":"Other","conditions":"Microbiology, Maxilla","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Microbial profile","description":"microbiological testing"}],"outcomes":[{"outcome_type":"primary","measure":"microbial types","time_frame":"6 months","description":"types of microbes on the sliva"}]}
{"nct_id":"NCT02393326","start_date":"2018-01-31","phase":"N/A","enrollment":0,"brief_title":"Biodentine Partial Pulpotomy of Pulpally Exposed Primary Molars","official_title":"Biodentine Partial Pulpotomy of Pulpally Exposed Primary Molars","primary_completion_date":"2019-01-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2020-01-31","last_update":"2018-03-14","description":"Objective: To compare success rates of biodentine partial pulpotomy versus formocresol pulpotomy treatment of pulpally exposed lower primary molars. After caries removal resulted in a pulp exposure, the pulp at the exposed area is amputated to a depth of 2 mm. The wound surface is irrigated and dried. After homeostasis is obtained, an assistant drew lots to randomly allocate the case to either the biodentine partial pulpotomy (PP) or the formocresol pulpotomy (FP) group. The follow-up for clinical and radiographic evaluation will be carried out at 6-month intervals.","other_id":"0644-14-HMO-CTIL","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":3,"maximum_age":7,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  The clinical criteria: primary molar with a deep carious lesion\r\n\r\n          -  Sufficient tooth structure for restoration with a stainless steel crown\r\n\r\n          -  No history of spontaneous pain\r\n\r\n          -  Tenderness to percussion or abnormal mobility\r\n\r\n          -  Abscess, fistula, or swelling of the gingiva, and with cessation of bleeding after a 2\r\n             mm depth of the pulp at the area of the exposure was amputated.\r\n\r\n          -  The radiographic criteria: a deep carious lesion in close proximity to the pulp\r\n             without furcation or radicular pathology\r\n\r\n          -  Obliteration of the pulp and root canal, or internal or external root resorption.\r\n\r\n          -  Physiologic root resorption, while included in the criteria, could not be more than\r\n             one-third of the root length.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  The clinical criteria: history of spontaneous pain\r\n\r\n          -  Tenderness to percussion or abnormal mobility\r\n\r\n          -  Abscess, fistula, or swelling of the gingiva, no cessation of bleeding after a 2 mm\r\n             depth of the pulp at the area of the exposure was amputated.\r\n\r\n          -  The radiographic criteria: tooth with furcation or radicular pathology\r\n\r\n          -  Obliteration of the pulp and root canal, or internal or external root resorption.\r\n\r\n          -  Physiologic root resorption more than one-third of the root length.\r\n      ","sponsor":"Hadassah Medical Organization","sponsor_type":"Other","conditions":"Pulpotomy|Tooth, Deciduous","interventions":[{"intervention_type":"Procedure","name":"Procedure: partial pulpotomy with biodentine","description":"After caries removal resulted in a pulp exposure, the pulp at the exposed area is amputated to a depth of 2 mm. The wound surface is irrigated and dried. After homeostasis is obtained, biodentine is gently applied to the wound surface, and then covered with reinforced zinc oxide-eugenol"},{"intervention_type":"Procedure","name":"Procedure: Formocresol pulpotomy","description":"Following removal of the coronal pulp and achievement of homeostasis, a cotton pellet moistened with formocresol (1: 5 Buckley's solution) is placed on the amputated pulp for 5 min. The pulp stumps is then covered by IRM."}],"outcomes":[{"outcome_type":"primary","measure":"partial pulpotomy clinical success rate","time_frame":"6-month intervals, up to 2 years. From date of randomization until the date of first documented failure or up to 24 months","description":"Treatment is considered a clinical failure if one or more of the following signs are observed: pain, abscess or sinus opening, tenderness upon percussion, or abnormal tooth mobility. The treatment is regarded successful if clinical evaluation does not indicate any signs of failure."},{"outcome_type":"primary","measure":"partial pulpotomy radiographic success rate","time_frame":"6-month intervals, up to 2 years. From date of randomization until the date of first documented failure or up to 24 months","description":"For radiographic evaluation, the treatment is rated as a failure when one or more of the following signs are present: furcation or periapical radiolucency, pathologic external root resorption, or internal resorption. The treatment is regarded successful if radiographic evaluation does not indicate any signs of failure."},{"outcome_type":"secondary","measure":"Formocresol pulpotomy clinical success rate","time_frame":"6-month intervals, up to 2 years. From date of randomization until the date of first documented failure or up to 24 months","description":"Treatment is considered a clinical failure if one or more of the following signs are observed: pain, abscess or sinus opening, tenderness upon percussion, or abnormal tooth mobility. The treatment is regarded successful if clinical evaluation does not indicate any signs of failure."},{"outcome_type":"secondary","measure":"Formocresol pulpotomy radiographic success rate","time_frame":"6-month intervals, up to 2 years. From date of randomization until the date of first documented failure or up to 24 months","description":"For radiographic evaluation, the treatment is rated as a failure when one or more of the following signs are present: furcation or periapical radiolucency, pathologic external root resorption, or internal resorption. The treatment is regarded successful if radiographic evaluation does not indicate any signs of failure."}]}
{"nct_id":"NCT03887208","start_date":"2018-01-31","phase":"Phase 1/Phase 2","enrollment":100,"brief_title":"Therapy of Scars and Cutis Laxa With Autologous Adipose Derived Mesenchymal Stem Cells","official_title":"Evaluation the Safety and Efficacy of the Treatment of Scars and Cutis Laxa Syndrome With the Use of Autologous (Fresh and Stored) Stem Cells Isolated From Adipose Tissue.","primary_completion_date":"2019-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-01-31","last_update":"2020-01-28","description":"The aim of this study is to compare clinical outcomes of patients with large scars or Cutis laxa treated with injections of autologous stromal vascular fraction cells (SVF) and adipose-derived mesenchymal stem cells (ADSC).","other_id":"2ABC Therapy","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","intervention_model_description":"Patients receive injections of autologous SVF or ADSC cells isolated in the laboratory from adipose tissue.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age 18 - 75 years at the time of qualification to the study\r\n\r\n          2. Signing informed consent form\r\n\r\n          3. Women / men\r\n\r\n          4. Scar or cutis laxa\r\n\r\n             Scar eligibility conditions:\r\n\r\n               -  Area:\r\n\r\n                    -  Stomach\r\n\r\n                    -  Limbs\r\n\r\n                    -  Face\r\n\r\n                    -  Back\r\n\r\n                    -  Chest and neck\r\n\r\n                         -  Onset time: over 6 months\r\n\r\n                         -  Scars previously untreated\r\n\r\n                         -  Atrophic and hypertrophic scars\r\n\r\n                         -  Two scars in close location, each from 2 to 6 cm long and a total\r\n                            surface area of 1 sq. cm to 5 sq. cm or single scar\r\n\r\n               -  Etiology\r\n\r\n                    -  traumatic\r\n\r\n                    -  burns\r\n\r\n                    -  surgical\r\n\r\n             Cutis laxa eligibility conditions:\r\n\r\n               -  Sun discoloration\r\n\r\n               -  Pigmentation changes\r\n\r\n               -  Solar stains\r\n\r\n               -  Pigment changes also called age spots.\r\n\r\n               -  Erythema\r\n\r\n               -  Cracked blood vessels\r\n\r\n               -  Ruby nevus\r\n\r\n               -  Atrophic changes of the skin and subcutaneous tissue\r\n\r\n               -  Changes symmetrically present on both hands\r\n\r\n          5. Without previous aesthetic treatment in this area, previous standard care.\r\n\r\n          6. Patient's health which allows anesthesia for liposuction.\r\n\r\n          7. Ready for follow-up visits\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Active cancer (diagnosed during past 5 years), excluding cured nonmelanoma skin cancer\r\n             or other non-invasive or in situ cancer (eg. cervical cancer)\r\n\r\n          2. Active chronic infection\r\n\r\n          3. Chronic use of NSAIDs\r\n\r\n          4. Taking any anticoagulant by the patient during 1 hour prior to surgery (excluding\r\n             prophylactic heparin before liposuction).\r\n\r\n          5. Coagulation disorders in medical history and actual test results out of normal ranges.\r\n\r\n          6. Skin infections.\r\n\r\n          7. Allergies to medications used during liposuction (eg. Lidocaine and derivatives).\r\n\r\n          8. Status post radiotherapy or chemotherapy\r\n\r\n          9. Any other disease or condition that may change the evaluation of skin condition (eg.\r\n             autoimmune disease of the connective tissue)\r\n\r\n         10. Taking the corticosteroid drugs or cytotoxic medications during the past 30 days\r\n\r\n         11. Allergy to materials of animal origin\r\n\r\n         12. Diagnosis of diabetes Type I\r\n\r\n         13. Diagnosis of AIDS, hepatitis B virus (HBV) or hepatitis C virus (HCV) (positive\r\n             laboratory test result)\r\n\r\n         14. Hirsutism or a tattoo at the treatment site\r\n\r\n         15. Insufficient fat tissue for fat donation\r\n\r\n         16. Scar after removal of cancer.\r\n\r\n         17. The patient does not qualify to participate in this study in the opinion of the\r\n             investigator\r\n\r\n         18. Pregnancy, breast feeding.\r\n\r\n         19. Photoallergy or using the drugs causing photoallergy.\r\n\r\n         20. Active herpes\r\n\r\n         21. Idiopathic keloids\r\n\r\n         22. Esthetic or medicinal treatments done previously at the treatment site\r\n\r\n         23. The use of derivatives of vitamin A during 6 months before the treatment\r\n\r\n         24. Fitzpatrick phototype V and VI\r\n\r\n         25. Patients with mental disorders or addicted to drugs and/or alcohol.\r\n\r\n         26. Participation in other clinical study during the past 6 months.\r\n\r\n         27. Reactive result of serological and viral tests (ie. HIV-1 and 2 (HIV Ag/ Ab)\r\n\r\n               -  Hepatitis B Virus Infection, - HbsAg and Anti-hepatitis B core antigen\r\n                  (Anti-HBc);\r\n\r\n               -  Hepatitis C Virus Infection, Anti-HCV;\r\n\r\n               -  Syphilis specific tests\r\n      ","sponsor":"Medical University of Warsaw","sponsor_type":"Other","conditions":"Skin|Scar|Cutis Laxa|Keloid|Cicatrix","interventions":[{"intervention_type":"Procedure","name":"Procedure: Normal saline injection","description":"Subcutaneous Normal saline injection"},{"intervention_type":"Procedure","name":"Procedure: Laser therapy","description":"non-ablative fractional laser therapy of skin"},{"intervention_type":"Biological","name":"Biological: Autologous ADSC injection","description":"Subcutaneous injection of autologous ADSC"}],"outcomes":[{"outcome_type":"primary","measure":"Change in patient's skin condition","time_frame":"0-27 weeks","description":"Evaluation of the effectiveness of the method of application of stem cells in the described indications by evaluating the time after which there will be an improvement of 50% in the point evaluation scale of the quality of life of the patient in relation to the baseline values.\r\nScale 1: Impact of skin problems on the quality of life. The aim is to assess to what extent skin ailments have affected the patient's life in the last 2 weeks.\r\nA five-level scale of evaluation (from 'very strong' to 'not applicable') .The \"very strong\" value means the worst result, while the \"not applicable\" value is the best result."},{"outcome_type":"primary","measure":"Evaluation of skin problems. Assessment of skin related complaints since the last visit.","time_frame":"0-27 weeks","description":"Scale 2: A seven-level grading scale (from \"0\" to \"6\").The value \"0\" means the best result, while \"6\" is the worst result."},{"outcome_type":"primary","measure":"The assessment of the scar by the patient.","time_frame":"0-27 weeks","description":"Scale 3: Six-point scale (from '1' to '6'). The value \"1\" means the best result, while \"6\" is the worst result."},{"outcome_type":"secondary","measure":"Changes in volume of the skin (USG)","time_frame":"0-27 weeks","description":"Changes in the volume of the fat layer at the application site assessed by skin (USG) thickness."},{"outcome_type":"secondary","measure":"Changes in skin surface morphology (digital imagining)","time_frame":"0-27 weeks","description":"Changes in skin surface morphology assessed by digital imaging."},{"outcome_type":"secondary","measure":"Record of adverse events","time_frame":"0-27 weeks","description":"Evaluation of safety of the method of cells' application assessed by adverse events"}]}
{"nct_id":"NCT03350503","start_date":"2018-01-30","phase":"N/A","enrollment":125,"brief_title":"AcrySof IQ Toric A-Code Post-Market Clinical Study","official_title":"AcrySof IQ Toric A-Code Post-Market Clinical Study","primary_completion_date":"2019-05-23","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2022-02-28","last_update":"2021-06-08","description":"The purpose of this study is to clinically confirm the rotational stability of a modified AcrySof IQ toric intraocular lens (IOL) in a Japanese population.","other_id":"ILV814-P001","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosis of cataracts with planned cataract removal by phacoemulsification\r\n\r\n          -  Calculated lens power within the available range\r\n\r\n          -  Able to sign informed consent and complete all study visits\r\n\r\n          -  Other protocol-defined inclusion criteria may apply.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Eye conditions as specified in the protocol\r\n\r\n          -  Uncontrolled glaucoma\r\n\r\n          -  Pregnancy, current or planned\r\n\r\n          -  Other protocol-defined exclusion criteria may apply.\r\n      ","sponsor":"Alcon Research","sponsor_type":"Industry","conditions":"Cataract|Astigmatism","interventions":[{"intervention_type":"Device","name":"Device: AcrySof IQ Toric A-code IOL","description":"Intended to provide visual acuity, including astigmatism correction, over the lifetime of the cataract patient"},{"intervention_type":"Procedure","name":"Procedure: Cataract surgery","description":"Removal of cataractous lens and implantation of IOL"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants With Absolute Intraocular (IOL) Rotation (Visit 00 to Visit 4)","time_frame":"Visit 00 (Day 1 operative), Visit 4 (Day 120-180 postoperative)","description":"IOL rotation was defined as the IOL axis difference between study visits. A photograph of the eye was taken, and IOL rotation was calculated as the angle between the toric mark on the IOL at Visit 4 and the reference point from Visit 00 (minimum 0 degrees, maximum 180 degrees). A lower value indicates greater IOL stability. No confirmatory hypothesis testing was conducted."}]}
{"nct_id":"NCT03291639","start_date":"2018-01-25","enrollment":17,"brief_title":"Functional Plasticity of Human IL-17-producing CD8+ T Cells","official_title":"Functional Plasticity of Human IL-17-producing CD8+ T Cells","primary_completion_date":"2018-01-25","study_type":"Observational [Patient Registry]","rec_status":"Completed","completion_date":"2018-08-30","last_update":"2021-07-29","description":"Human Tc17 cells (IL-17-producing CD8+ T cells) have been found to contribute to different kinds of human inflammatory and malignant diseases. Previous studies indicate that Tc17 cells can convert to Tc1 cells (IFN--producing CD8+ T cells) in tumor bearing mice to exert anti-tumor effect. Base on these results in murine models, human Tc17 may have potential in developing cancer immunotherapy. However, there is limited evidence to reveal the characteristics and functional plasticity of human Tc17 cells. In this proposal, we aim to optimize the differentiation of Tc17 cells and then investigate whether the reprograming of Tc17 to Tc1 cells can promote the anti-tumor cytotoxicity. Preliminarily, we isolated CD8+ T cells from the peripheral blood mononuclear cells of healthy donors to induce Tc17 differentiation. Human CD8+ T cells were stimulated with anti-CD3/anti-CD28 antibodies, TGF-, IL-1, IL-6, IL-23, IL-2, anti-IFN-, and anti-IL-4 antibodies. After 10 days in culture, there were 4% of IL-17A+IFN-- and 7% of IL-17A+IFN-+ CD8+ T cells. However, IFN-+ CD8+ T cells still represented high percentage, although it's significantly lower than that in Tc1 cells. Our preliminary study demonstrated that Tc17 cells expressed lower levels of cytotoxic molecules than Tc1 cells. We will further test if the expressions of cytotoxic molecules, including perforin and granzyme B, and EOMES will be enhanced by various cytokines. Ultimately, we will evaluate the functional plasticity of Tc17 cells under various cytokine stimulation. Collectively, success of this project will establish more insight for human Tc17 cells and provide the information for future developing human CD8+ T cell-mediate immunotherapy.","other_id":"CMUH106-REC3-107","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":20,"population":"10 healthy donors and 20 cancer patients","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  cancer patients\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  pregnancy\r\n      ","sponsor":"China Medical University Hospital","sponsor_type":"Other","conditions":"IL-17+ CD8 T Cells in Cancer Patients","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Functional plasticity of IL-17+ CD8 T cells","time_frame":"culture cells for 16 days","description":"To skew human IL-17+ CD8 T cells and add specific cytokines to convert IL-17 CD8 T cells to IFN-gamma CD8 T cells"}]}
{"nct_id":"NCT03308903","start_date":"2018-01-22","enrollment":40,"brief_title":"Use of the Sit-To-Stand Task as a Screening Tool for Sarcopenia The","official_title":"Can the Sit-to-Stand Test be Used as a Screening Tool to Detect Sarcopenia in Community-dwelling Older People?","primary_completion_date":"2019-01-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2019-03-31","last_update":"2018-10-10","description":"A common condition associated with ageing is sarcopenia, which is a progressive decrease in muscle mass. Sarcopenia is associated with adverse outcomes including increased mortality, and places a major burden on healthcare spending, with the annual cost of sarcopenia in the United States exceeding that of osteoporosis and hip fracture. In the UK, the prevalence of sarcopenia in community-dwelling older people has been estimated at 5% for men and 8% for women. Current guidelines for sarcopenia diagnosis require muscle mass to be measured using costly devices such as Dual Energy X-ray Absorptiometry (DXA) and Magnetic Resonance Imaging (MRI). Previous research has found strong relationships between the sit-to-stand (STS) test and both muscle mass and muscle strength. This pilot study aims to examine this relationship in community-dwelling older people to develop predictive equations for initial screening of sarcopenia. Forty subjects will be tested using the diagnostic criteria developed by the European Working Group on Sarcopenia in Older People (EWGSOP). Muscle mass will be measured using the DXA and diagnostic ultrasound. Muscle strength will be measured using isokinetic dynamometer, handgrip dynamometry, and hand-held dynamometry. Functional performance will be measured using the Timed-up-and-Go and gait velocity, and the STS. Subjects will perform two variants of the STS the five times STS (5STS), which requires subjects to perform five consecutive STS movements as quick as possible, and the 30-second STS (30STS), which requires subjects to perform as many STS movements as possible in 30 seconds. All testing will be completed in a single session lasting 90 minutes for each subject. Testing will be performed at the University of Bedfordshire Polhill Campus. Subject recruitment will be recruited using advertisement posters and word of mouth.","other_id":"IHREC751","observational_model":"Cohort","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":65,"population":"Community-dwelling people aged 65 years and over with no musculoskeletal problems.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female\r\n\r\n          -  Community-dwelling adults\r\n\r\n          -  Aged 65+ years\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Cardiovascular and/or respiratory problems\r\n\r\n          -  High blood pressure (140/90mmHG or higher)\r\n\r\n          -  Low blood pressure (90/60mmHg or lower)\r\n\r\n          -  A diagnosis of arthritis and/or osteoporosis\r\n\r\n          -  Had a musculoskeletal injury within the last twelve months\r\n\r\n          -  Had an X-ray examination with contrast medium in the 3 weeks prior to the DEXA scan\r\n             (if this does apply to the participant, the date of which they will participate will\r\n             be delayed until 3 weeks after the date of their contrast scan)\r\n\r\n          -  Recently had a Nuclear Medicine diagnostic or therapy investigation, depending on its\r\n             nature (this will be referred to the Medical Physics Expert to determine if and when\r\n             the participant can receive a DEXA scan for this study)\r\n\r\n          -  Any significant internal metalwork or irremovable external metalwork.\r\n      ","sponsor":"University of Bedfordshire","sponsor_type":"Other","conditions":"Sarcopenia","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: DEXA scan","description":"The participant will undergo a whole-body DEXA (DEXA GE Medical Systems, Chalfont St Giles, UK) scan, lasting approximately 5 minutes. This scan will produce body composition data, including estimates of lean body mass (LBM), appendicular lean mass (aLM) and body fat percentage (BF%)."}],"outcomes":[{"outcome_type":"secondary","measure":"Gait velocity","time_frame":"2 minutes","description":"Participants will be asked to walk at a comfortable pace between two lines, marked five metres apart. The time taken will be measured with a stopwatch, with total time taken as the score."},{"outcome_type":"secondary","measure":"Handheld dynamometer assessment of muscle strength","time_frame":"5 minutes","description":"Measures of isometric muscle strength will be measured using the hand-held dynamometer (HHD). Measures will be taken from the hip flexors, quadriceps, hamstrings, gastroc-soleus complex and tibialis anterior of both lower extremities."},{"outcome_type":"primary","measure":"Muscle mass measurement using dual X-ray absorptiometry","time_frame":"5 minutes","description":"The participant will undergo a whole-body DEXA (DEXA; GE Medical Systems, Chalfont St Giles, UK) scan, lasting approximately 5 minutes. This scan will produce body composition data, including M and body fat percentage (BF%). For the purpose of this study, aLM values will be calculated in relation to height (sum of LBM in the arms and legs, scaled to height) (aLM/ht²)."},{"outcome_type":"secondary","measure":"Hip and knee flexion and extension and ankle plantarflexion and dorsiflexion of both lower extremities on the Biodex System 3 Isokinetic Dynamometer","time_frame":"5 minutes","description":"Participants will perform two sets of five repetitions of hip and knee flexion and extension and ankle plantarflexion and dorsiflexion of both lower extremities on the Biodex System 3 Isokinetic Dynamometer (IKD) (Suffolk, UK), with a 2-minute rest period between sets. The angular velocity of the IKD will be set at 60º/s."},{"outcome_type":"secondary","measure":"Five times sit to stand test","time_frame":"5 minutes","description":"Participants will sit in a straight back chair with a solid seat that is 16\" high. Participants will have their arms folded across their chest. They will then stand up and sit down as quickly as possible five times, keeping their arms folded across their chest. The test is measured with a stopwatch and is completed when the participant stands for the 5th time."},{"outcome_type":"secondary","measure":"Diagnostic ultrasound","time_frame":"5 minutes","description":"Sonographic estimates of LBM will be measured using a diagnostic ultrasound. Muscle thickness measurements will be taken from both arms and legs of the participants."},{"outcome_type":"secondary","measure":"Grip strength","time_frame":"5 minutes","description":"A measure of handgrip strength will be taken using the JAMAR PLUS + (Patterson Medical, IL, USA) of both the participant's upper extremities. Measures will be taken twice with a 2-minute rest period between trials. This requires the participant to exert their maximal grip in an isometric contraction."},{"outcome_type":"secondary","measure":"Timed Up and Go test","time_frame":"2 minutes","description":"The participant sits on a standard armchair, placing his/her back against the chair and resting his/her arms chair's arms. The participant is instructed to use a comfortable and safe walking speed. The participant walks to a line that is 3 meters away, turns around at the line, walks back to the chair, and sits down. The test ends when the patient's buttocks touch the seat.\r\nA stopwatch is used to time the test (in seconds)."},{"outcome_type":"secondary","measure":"30-second sit to stand test","time_frame":"5 minutes","description":"Participants will sit in a straight back chair with a solid seat that is 16\" high. Participants will have their arms folded across their chest. They will then stand up and sit down as quickly as possible for 30 seconds, keeping their arms folded across their chest. The test is measured with a stopwatch and is completed after 30 seconds, with the number of completed sit to stands taken as the score."}]}
{"nct_id":"NCT03286283","start_date":"2018-01-22","phase":"N/A","enrollment":55,"brief_title":"The Use of J-Plasma for Dermal Resurfacing","official_title":"A Prospective, Multicenter, Single Arm Clinical Study Evaluating the Use of J-Plasma for Dermal Resurfacing","primary_completion_date":"2018-08-20","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-11-16","last_update":"2019-08-07","description":"This study evaluates the safety and effectiveness of J-Plasma in the reduction of facial wrinkles and rhytides. It is a multi-center, single arm, evaluator-blind prospective study of 55 study subjects who are seeking a procedure to reduce the appearance of wrinkles and rhytides and will be conducted at up to 5 investigational centers in the United States. Each study subject will receive one procedure with J-Plasma at enrollment. Follow-up will occur immediately following the procedure, at 10 days, 1, 3, and 6 months after enrollment.","other_id":"VP-1558","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"This is a multi-center, single arm, evaluator-blind prospective study of 55 study subjects who are seeking a procedure to reduce the appearance of wrinkles and rhytides. Enrolled study subjects will receive one procedure with J-Plasma at enrollment. Wrinkle severity will be assessed using the Fitzpatrick Wrinkle and Elastosis Scale (FWS) at baseline and at each follow-up time point. Scores at each follow-up time point will be compared to the scores at baseline for each enrolled subject.","sampling_method":"","gender":"All","minimum_age":30,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Male or female subjects 30 years of age.\r\n\r\n          2. Subject is seeking improvement of facial appearance by reducing facial wrinkles and\r\n             rhytides.\r\n\r\n          3. Subject with a facial wrinkle score rating of at least 2 on the FWS as determined by\r\n             the investigator.\r\n\r\n          4. Subject with a Fitzpatrick Skin Scale score III.\r\n\r\n          5. Subject is willing and able to provide written informed consent.\r\n\r\n          6. Subject is willing and able to comply with protocol requirements, including obtaining\r\n             study-required images/photos and assessments, and returning for follow-up visits.\r\n\r\n          7. Subject is willing to release rights to study Sponsor for the use of the photos,\r\n             including in potential publication.\r\n\r\n          8. Subject is willing to abstain from other facial cosmetic procedures through the 6\r\n             month follow-up visit; examples include, but are not limited to, laser or chemical\r\n             re-surfacing, dermabrasion, neuromodulator and/or filler injections, aesthetic facial\r\n             surgery, etc.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Subject with a Fitzpatrick Skin Scale score >III.\r\n\r\n          2. Subject is pregnant or lactating.\r\n\r\n          3. Active HSV-1 or diabetes mellitus.\r\n\r\n          4. Active cut, wound, or infection on the skin of the face.\r\n\r\n          5. Subject has used, within the past 30 days, Accutane or any medication that can cause\r\n             dermal hypersensitivity.\r\n\r\n          6. Subject has a history of autoimmune disease.\r\n\r\n          7. Subject with a bleeding disorder or who is on blood thinning medication that may be at\r\n             risk for bleeding.\r\n\r\n          8. Subject has a known adverse reaction to anesthetics.\r\n\r\n          9. Subjects with active skin disease of the facial area or known connective tissue\r\n             disease.\r\n\r\n         10. Subjects with known susceptibility to keloid formation or hypertrophic scarring.\r\n\r\n         11. Subjects with present cancerous or pre-cancerous lesions in the area to be treated.\r\n\r\n         12. Subject who, for any reason, suspects that they will not be able to complete the\r\n             prescribed follow-up assessment(s);\r\n\r\n         13. Subject has had concurrent therapy that, in the investigator's opinion, would\r\n             interfere with the evaluation of the safety and efficacy of the study treatment\r\n             method.\r\n\r\n         14. Subject is not willing to release rights to study Sponsor for the use of the photos,\r\n             including in potential publication.\r\n\r\n         15. Subject is enrolled in another investigational (drug or device) clinical trial that\r\n             can interfere with this study's assessments.\r\n\r\n         16. Subject has undergone a facelift procedure or received facial injections within the\r\n             past year.\r\n      ","sponsor":"Apyx Medical","sponsor_type":"Industry","conditions":"Facial Wrinkles|Rhytides","interventions":[{"intervention_type":"Device","name":"Device: J-Plasma","description":"Dermal resurfacing procedure with J-Plasma."}],"outcomes":[{"outcome_type":"other","measure":"Achievement of Re-epithelialization - 1 Month","time_frame":"1 Month","description":"Achievement of re-epithelialization by facial zone and across facial zones after treatment"},{"outcome_type":"primary","measure":"Improvement in Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score","time_frame":"Baseline to 3 months","description":"The comparison of the proportion of subjects (i.e. percentage of treatment responders) with a ≥ 1-score improvement on the FWS at the 3-month visit, as compared to baseline as determined by at least 2 out of 3 blinded Independent Photographic Reviewers. Min=1, Max=9, where 1 is best and 9 is worst. The larger the difference between the baseline and 3 month scores, the greater the improvement."},{"outcome_type":"primary","measure":"Adverse Event Rate and Duration","time_frame":"Up to 3 months","description":"Adverse event rates, categorized by duration"},{"outcome_type":"secondary","measure":"Number of Participants With a ≥ 1-score Improvement on the Fitzpatrick Wrinkle and Elastosis Scale (FWS) and at Least an \"Improved\" Rating on the Modified Global Aesthetic Improvement Scale (GAIS) at the 3-month Visit.","time_frame":"Baseline to 3 months","description":"Assessment of modified Global Aesthetic Improvement Scale (GAIS) at the 3-month visit compared to baseline as assessed by the investigator. Scale ratings: \"Very much improved,\" \"Much improved,\" \"Improved,\" \"No change,\" \"Worse,\" \"Much worse,\" and \"Very much worse.\" An \"improvement\" on the modified GAIS includes \"Improved,\" \"Much improved,\" or \"Very much improved.\""},{"outcome_type":"secondary","measure":"Evaluation of Pain and Discomfort","time_frame":"Baseline to 3 months","description":"The evaluation of the pain and discomfort after treatment as reported by the subject on a 10-point visual analog scale (VAS). Mean change in VAS from baseline to 3 months. 0 = best possible level of pain and discomfort, 10= worst possible level of pain and discomfort."},{"outcome_type":"other","measure":"Number of Participants With an Improvement on the FWS (as Scored by Independent Reviewers) and Modified GAIS Scale (as Scored by Participants) at 3 Months","time_frame":"Baseline to 3 months","description":"Fitzpatrick Wrinkle and Elastosis Scale (FWS) ≥ 1-score improvement and ≥ 75% agreement with at least an \"improved\" rating by the subject on the modified Global Aesthetic Improvement Scale (GAIS) at 3 months compared to baseline. FWS Scale: Min=1, Max=9, where 1 is best and 9 is worst. The larger the difference between the baseline and 3 month scores, the greater the improvement. Modified GAIS Scale ratings: \"Very much improved,\" \"Much improved,\" \"Improved,\" \"No change,\" \"Worse,\" \"Much worse,\" and \"Very much worse.\" An \"improvement\" on the modified GAIS includes \"Improved,\" \"Much improved,\" or \"Very much improved.\""},{"outcome_type":"other","measure":"Mean Change in Fitzpatrick Wrinkle and Elastosis Scale (FWS) From Baseline to 3-month Follow-up Visit","time_frame":"Baseline to 3 months","description":"Magnitude of improvement measured by the mean change in Fitzpatrick Wrinkle and Elastosis Scale (FWS) from baseline to 3-month visit. Scale of 1 to 9 where 1 represents the lowest severity of wrinkles and 9 represents the greatest severity of wrinkles. Negative change value represents aesthetic improvement."},{"outcome_type":"other","measure":"Study Subject Satisfaction at 3-month Visit","time_frame":"3 Months","description":"Evaluation of the subject satisfaction as reported by the subject on a visual analog scale (VAS). VAS scale ranges 0-10, 0 = best possible level of satisfaction, 10= worst possible level of satisfaction"},{"outcome_type":"other","measure":"Achievement of Re-epithelialization - 10 Days","time_frame":"10 Days","description":"Achievement of re-epithelialization by facial zone and across facial zones after treatment"},{"outcome_type":"other","measure":"Achievement of Re-epithelialization - 3 Months","time_frame":"3 Months","description":"Achievement of re-epithelialization by facial zone and across facial zones after treatment"},{"outcome_type":"other","measure":"Mean Duration for Study Subject to Feel Comfortable in Public After Treatment","time_frame":"Up to 3 months","description":"Mean duration for study subject to feel comfortable in public after treatment as reported by the subject"},{"outcome_type":"other","measure":"Study Subject - Pain/Discomfort Daily 10-point Visual Analog Scale (VAS) Pre-procedure, Post-procedure, and Daily Through the 10 Day Follow-up Visit (10d FUV Visit Window: 9-14 Days)","time_frame":"Pre-procedure, post-procedure and Daily through 10 Day Follow-up Visit, approximately 9-14 days","description":"Daily 10-point Visual Analog Scale (VAS) pain assessments following treatment through the 10 day follow-up visit by diary day with a change from the VAS pain score at baseline. The 10 day follow-up visit window was 9-14 days. Not all participants recorded their VAS score every day on the daily diary; daily diary was collected from each participant at their 10 day follow-up visit (visit window: 9-14 days)."},{"outcome_type":"other","measure":"Proportion of Subjects With Correct Identification of 3-month Images","time_frame":"Baseline to 3 months","description":"The proportion of subjects (i.e. percentage of treatment responders) with correct identification of 3-month images, in comparison to baseline, as determined by at least 2 out of 3 blinded Independent Photographic Reviewers."}]}
{"nct_id":"NCT03318380","start_date":"2018-01-19","phase":"N/A","enrollment":640,"brief_title":"Contrast-Enhanced Ultrasound Imaging in Diagnosing Liver Cancer in Patients With Cirrhosis","official_title":"Contrast-Enhanced Ultrasound Evaluation of Focal Liver Lesions in Patients With Cirrhosis or Other Risk Factors for Developing HCC","primary_completion_date":"2022-03-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-03-31","last_update":"2021-09-01","description":"This clinical trial studies how well contrast-enhanced ultrasound imaging works in diagnosing liver cancer in patients with cirrhosis. Diagnostic procedures, such as contrast-enhanced ultrasound imaging, may help find and diagnose liver cancer.","other_id":"17F.310","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":21,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Capable of making informed decisions regarding his/her treatment\r\n\r\n          -  Have known cirrhosis or other risk factors for HCC, based on American Association for\r\n             the Study of Liver Diseases (AASLD) and European Association for the Study of the\r\n             Liver (EASL) guidelines (applicable in each site jurisdictions)\r\n\r\n          -  Patients with untreated focal liver observations on liver ultrasound or multiphase\r\n             contrast-enhanced CT or MRI performed as part of clinical standard of care within 4\r\n             weeks before patient enrollment.\r\n\r\n        OR\r\n\r\n         Patients with untreated focal liver observations scheduled for follow-up multiphase\r\n        contrast-enhanced CT or MRI, biopsy or surgical excision as part of clinical standard of\r\n        care. CEUS should be performed within 4 weeks before or after follow-up imaging or within 4\r\n        weeks before biopsy or surgical excision.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who are pregnant or lactating\r\n\r\n          -  Patients with focal liver observations less than 5 mm or greater than 5 cm in size\r\n\r\n          -  Patients with contraindications to CEUS\r\n\r\n          -  Patients with contraindications to both CT and MRI\r\n\r\n          -  Patients who are medically unstable, terminally ill, or whose clinical course is\r\n             unpredictable\r\n\r\n          -  Liver nodule previously treated with trans-arterial or thermal ablation\r\n\r\n          -  Patients who have received an investigational drug in the 30 days before CEUS, or will\r\n             receive one within 72 hour after their CEUS exam\r\n      ","sponsor":"Sidney Kimmel Cancer Center at Thomas Jefferson University","sponsor_type":"Other","conditions":"Liver Cirrhosis","interventions":[{"intervention_type":"Procedure","name":"Procedure: Dynamic Contrast-Enhanced Ultrasound Imaging","description":"Undergo CEUS"}],"outcomes":[{"outcome_type":"primary","measure":"Sensitivity of contrast-enhanced ultrasound evaluation (CEUS) for diagnosis of Hepatocellular cancer using a 95% confidence interval 95% confidence interval for HCC diagnosis using CEUS LR-5 classification","time_frame":"Up to 12 months","description":"A value of 67% for sensitivity is expected based on recent meta-analysis studies of CEUS for focal liver mass characterization."},{"outcome_type":"primary","measure":"Specificity of contrast-enhanced ultrasound evaluation (CEUS) for diagnosis of Hepatocellular cancer using a 95% confidence interval","time_frame":"Up to 12 months","description":"A value of 91% for specificity is expected based on recent meta-analysis studies of CEUS for focal liver mass characterization."},{"outcome_type":"primary","measure":"Positive Predictive Value of contrast-enhanced ultrasound evaluation (CEUS) for diagnosis of Hepatocellular cancer using a 95% confidence interval","time_frame":"Up to 12 months","description":"A value of 93% for Positive Predicative Value is expected based on recent meta-analysis studies of CEUS for focal liver mass characterization."},{"outcome_type":"primary","measure":"Negative Predictive Value of contrast-enhanced ultrasound evaluation (CEUS) for diagnosis of Hepatocellular cancer using a 95% confidence interval","time_frame":"Up to 12 months","description":"A value of 60% for Negative predictive value is expected based on recent meta-analysis studies of CEUS for focal liver mass characterization."}]}
{"nct_id":"NCT03422198","start_date":"2018-01-17","phase":"Phase 3","enrollment":108,"brief_title":"Short Course Vaginal Cuff Brachytherapy in Treating Patients With Stage I-II Endometrial Cancer","official_title":"Short Course Adjuvant Vaginal Cuff Brachytherapy (VCB) in Early Endometrial Cancer Compared to Standard of Care (SAVE)","primary_completion_date":"2022-01-08","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-01-08","last_update":"2021-01-15","description":"This randomized phase III trial studies short course vaginal cuff brachytherapy to see how well it works compared with standard of care vaginal cuff brachytherapy in treating patients with stage I-II endometrial cancer. Short course vaginal cuff brachytherapy, also known as internal radiation therapy, uses (over a shorter period) radioactive material placed directly into or near a tumor in the upper portion of the vagina to kill tumor cells.","other_id":"HCI103841","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically confirmed endometrial carcinoma: endometrioid type, serous, and clear\r\n             cell, to include tumors originating in the cervix, but are primarily located in the\r\n             uterus, and for whom vaginal cuff brachytherapy is indicated. Carcinosarcoma and other\r\n             sarcomas are permitted; Federation of Gynecology and Obstetrics (FIGO) stage I, with\r\n             one of the following combinations of stage and grade:\r\n\r\n               -  Stage IA, grade 2, 3\r\n\r\n               -  Stage IB, grades 1-3\r\n\r\n               -  Stage II, grades 1-3\r\n\r\n          -  Patients post hysterectomy and free from residual disease\r\n\r\n          -  World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG)-performance\r\n             status 0-2\r\n\r\n          -  Able to provide informed consent and willing to sign an approved consent form that\r\n             conforms to federal and institutional guidelines\r\n\r\n          -  Life expectancy of >2 years.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Stages of endometrial carcinoma other than described\r\n\r\n          -  Previous pelvic radiotherapy\r\n\r\n          -  Interval between the hysterectomy and planned start of radiotherapy exceeding 16 weeks\r\n      ","sponsor":"University of Utah","sponsor_type":"Other","conditions":"Endometrial Clear Cell Adenocarcinoma|Endometrial Endometrioid Adenocarcinoma|Endometrial Serous Adenocarcinoma|Stage I Uterine Corpus Cancer|Stage IA Uterine Corpus Cancer|Stage IB Uterine Corpus Cancer|Stage II Uterine Corpus Cancer|Uterine Corpus Carcinosarcoma|Uterine Corpus Sarcoma","interventions":[{"intervention_type":"Radiation","name":"Radiation: Vaginal Cuff Brachytherapy","description":"Undergo standard of care vaginal cuff brachytherapy"},{"intervention_type":"Radiation","name":"Radiation: Short course vaginal cuff brachytherapy","description":"Undergo short course vaginal cuff brachytherapy"}],"outcomes":[{"outcome_type":"primary","measure":"Health related quality of life (HRQOL) using the Global Health Score from the Quality of Life Questionnaire Core 30 (QLQ-C30)","time_frame":"At 1 month post treatment","description":"Scores determined from patient completed questionnaires will be compared between the two treatment arms one month after treatment completion. The primary analysis will be analysis of covariance with Global Health Score at one month post therapy as Gaussian response variable, treatment group as a fixed effect and baseline Global Health Score as a continuous adjustment variable.\r\nThe primary hypothesis is that the Global Health Score is non-inferior in the Experimental Arm compared to the Control Arm. Differences of 10 points or more in the global scales are widely viewed as being clinically significant when evaluating the results of randomized clinical trials and thus we will use a 10 point equivalence margin.\r\nThe primary analysis will be analysis of covariance with Global Health Score at one month post therapy as Gaussian response variable, treatment group as a fixed effect and baseline Global Health Score as a continuous adjustment variable."},{"outcome_type":"secondary","measure":"Treatment-related symptoms on HRQOL using European Organization for Research and Treatment of Cancer Endometrial Cancer Module (EORTC EN24), question 48","time_frame":"Up to 12 months","description":"Scores determined from patient completed question, Have you felt less feminine due to your disease or treatment? will be compared between the two treatment arms. Ordinal logistic regression will be used to analyze this question, with one month value as outcome variable, treatment arm as primary predictor, and the baseline value as covariate. A non-inferiority analysis will be performed with equivalence margin equal to 6.1 points, which represents approximately 1/2 standard deviation. Additional exploratory logistic regression analyses will include the values at all time points (baseline, one"},{"outcome_type":"secondary","measure":"Cost effectiveness (CE)","time_frame":"Up to 6 months","description":"Cost of procedures will be compared between the two treatment arms"}]}
{"nct_id":"NCT04807543","start_date":"2018-01-10","phase":"Phase 2","enrollment":100,"brief_title":"Effect of Progesterone on Latent Phase Prolongation in Patients With Preterm Premature Rupture of Membranes","official_title":"Effect of Progesterone on Latent Phase Prolongation in Patients With Preterm Premature Rupture of Membranes","primary_completion_date":"2020-10-10","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-12-10","last_update":"2021-03-19","description":"The aim of the study is to assess the efficacy of 17-hydroxyprogesterone caproate (17P) therapy on the latency period in pregnant women with Preterm premature rupture of membranes.","other_id":"ppprom","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"Triple","sampling_method":"","gender":"Female","minimum_age":20,"maximum_age":35,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Singleton pregnancy\r\n\r\n          -  Gestational age between 24 and 34 weeks\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Medical or obstetric conditions that could put them at risk for uterine atony ,\r\n             postpartum hemorrhage AND infection, such as\r\n\r\n               -  Emergency Cesarean section.\r\n\r\n               -  Chorioamnionitis.\r\n\r\n               -  Placenta previa.\r\n\r\n               -  Multiple gestation.\r\n\r\n               -  Preeclampsia.\r\n\r\n               -  Macrosomia.\r\n\r\n          -  Non reassuring fetal status or fetal distress\r\n\r\n          -  Presence of fetal anomalies incompatable with life\r\n\r\n          -  Woman with antepartum haemorrhage\r\n\r\n          -  Diagnosis of Established preterm labor\r\n      ","sponsor":"Ain Shams University","sponsor_type":"Other","conditions":"Preterm Premature Rupture of Membrane","interventions":[{"intervention_type":"Drug","name":"Drug: 17-hydroxyprogesterone caproate","description":"intramuscular injection weekly"},{"intervention_type":"Drug","name":"Drug: Castor Oil","description":"intramuscular injection weekly"}],"outcomes":[{"outcome_type":"primary","measure":"prolongation of the pregnancy until a favorable gestational age","time_frame":"10 to 12 weeks (up to 34.0 weeks of gestation or documentation of fetal lung maturity at 32.0 to 33.9 weeks.)","description":"The most common method of measuring gestational age in weeks is by calculating the time since the last menstrual period based on dates provided by a woman at the first prenatal visit IF not available first trimester Ultrasound will be used"},{"outcome_type":"secondary","measure":"Latency .","time_frame":"10 to 12 weeks (interval in weeks from randomization to delivery)","description":"The most common method of measuring gestational age in weeks is by calculating the time since the last menstrual period based on dates provided by a woman at the first prenatal visit IF not available first trimester Ultrasound will be used"},{"outcome_type":"secondary","measure":"Composite neonatal morbidity","time_frame":"1 week (from delivery to 1 week post Natal)","description":"by Apgar score ,blood gases ,and labs"}]}
{"nct_id":"NCT03300674","start_date":"2018-01-10","phase":"Phase 4","enrollment":154,"brief_title":"Intravenous Lidocaine Randomized Comparative Effectiveness Trial","official_title":"Intravenous Lidocaine Versus Hydromorphone for Acute Abdominal Pain. A Randomized Trial","primary_completion_date":"2018-08-16","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-08-28","last_update":"2020-08-10","description":"This is a randomized, double-blind, emergency department based, comparative effectiveness study of two medication for acute abdominal pain: intravenous lidocaine and intravenous hydromorphone. Patients will be enrolled during an emergency department visit and followed throughout their emergency department course and then by telephone 7 days later.","other_id":"2017-8408","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:Eligible patients are those who present to an ED for treatment of acute\r\n        abdominal pain. Acute will be defined as pain for no more than seven days. At the time of\r\n        enrollment, the ED treatment plan must include use of an intravenous opioid.\r\n\r\n        Exclusion Criteria: Patients will be excluded from participation if they have cardiac\r\n        conduction system impairment (QTc duration > 0.5s, QRS duration > 0.12s, or PR interval\r\n        duration > 0.2s), known renal (CKD >2) or liver disease (Childs-Pugh B or greater), are\r\n        hemodynamically unstable, as determined by the attending physician, are pregnant or\r\n        breastfeeding, or have a known allergy to either medication. Patients will also be excluded\r\n        if they have used prescription or illicit opioids within the previous week, or if they have\r\n        a chronic pain disorder, defined as use of any analgesic medication on more days than not\r\n        during the month preceding the acute episode of pain. Patients weighing < 60kg or > 120kg\r\n        will be excluded.\r\n\r\n        -\r\n      ","sponsor":"Montefiore Medical Center","sponsor_type":"Other","conditions":"Abdominal Pain","interventions":[{"intervention_type":"Drug","name":"Drug: Hydromorphone","description":"Hydromorphone intravenous infusion"},{"intervention_type":"Drug","name":"Drug: Lidocaine","description":"Lidocaine intravenous infusion"}],"outcomes":[{"outcome_type":"primary","measure":"Change in 0-10 Pain Scale Between Baseline and 90 Minutes","time_frame":"up to 90 minutes","description":"Participants were asked to describe their pain on a scale from 0 to 10 with 0= no pain and 10= the worst pain imaginable"},{"outcome_type":"secondary","measure":"Rescue Medication","time_frame":"4 hours","description":"no need for off-protocol parenteral pain medication during the ED visit. The following parenteral medications will be considered off protocol pain medication: any opioid, any non-steroidal anti-inflammatory drug"},{"outcome_type":"secondary","measure":"Adverse Events","time_frame":"4 hours","description":"Any new symptom development after administration of investigational medication"}]}
{"nct_id":"NCT03350022","start_date":"2018-01-10","phase":"N/A","enrollment":102,"brief_title":"Sham Feeding Post-operative Infants","official_title":"Pilot Study on Sham Feeding in Post-operative Gastrointestinal Surgery Infants","primary_completion_date":"2019-09-04","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-09-04","last_update":"2020-02-20","description":"The purpose of this pilot study is to evaluate a feeding technique, sham feeding, to promote adequate oral skills in order to prevent oral aversion and/or poor oral skills due to the delay in oral feeds for surgical reasons. Sham feeding is intended for infants who are expected to have a prolonged course without normal enteral feeding by mouth.","other_id":"17-05475-FB","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","maximum_age":2,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Neonates at least 34 weeks post-menstrual age who have a history of gastrointestinal\r\n             surgery, require no respiratory support more than 2 lpm by nasal cannula, and have an\r\n             anticipated prolonged course with contraindication to normal oral or enteral feeding.\r\n             They must have a diagnosis of gastroschisis awaiting return of bowel function, bowel\r\n             atresia or other obstruction with anticipated feeding contraindication longer than 30\r\n             days, or short bowel syndrome intolerant of full intermittent oral feeding.\r\n\r\n          2. Mothers of enrolled neonates\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Lack of consent or parental consent.\r\n\r\n          2. Contraindication to sham feeding as determined by the responsible medical provider.\r\n      ","sponsor":"Le Bonheur Children's Hospital","sponsor_type":"Other","conditions":"Newborn Morbidity|Oral Aversion|Gastroschisis|Bowel Obstruction|Short Bowel Syndrome","interventions":[{"intervention_type":"Procedure","name":"Procedure: Sham Feeding","description":"Sham feeding will be offered to participants."}],"outcomes":[{"outcome_type":"primary","measure":"Time to full feeds","time_frame":"1 year","description":"Time to full oral feeds after resolution of feeding contraindications"},{"outcome_type":"secondary","measure":"Growth","time_frame":"1 year","description":"Infant growth parameters"},{"outcome_type":"secondary","measure":"Duration of breast feeding","time_frame":"1 year","description":"Duration of breast feeding or pumping of mother's milk"},{"outcome_type":"secondary","measure":"Maternal satisfaction","time_frame":"1 year","description":"Maternal satisfaction survey after intervention"}]}
{"nct_id":"NCT03413449","start_date":"2018-01-08","enrollment":360,"brief_title":"A Prospective Study Frailty for Esophagectomy and Lung Resection in Thoracic Surgery","official_title":"A Prospective Study Frailty for Esophagectomy and Lung Resection in Thoracic Surgery","primary_completion_date":"2019-07-02","study_type":"Observational","rec_status":"Active, not recruiting","completion_date":"2023-07-02","last_update":"2021-09-05","description":"The purpose of this study is to develop an all-encompassing frailty model using laboratory and functional studies. A frailty model will help us determine prior to surgery who will require rehabilitation and skilled nursing needs beyond discharge. This model will also help us determine who will likely be readmitted and why they will be readmitted. Understanding these things can help us prevent some of them from occurring in the future.","other_id":"17-1708","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients who are diagnosed with esophageal or lung cancer and are referred for surgery are\r\n        included.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  All patients >18 years old who are undergoing pneumonectomy, lobectomy or\r\n             esophagectomy with a cancer diagnosis over a 1-year enrollment.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who are unable to sign a consent.\r\n      ","sponsor":"The Cleveland Clinic","sponsor_type":"Other","conditions":"Lung Cancer|Thoracic|Thoracic Neoplasm|Esophageal Cancer|Surgery--Complications|Surgery|Sarcopenia|Malnutrition|Frail Elderly Syndrome","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Frailty model","description":"Grip strength\r\n30 second chair sit stand test\r\nPsoas muscle area\r\nSix minute walk"}],"outcomes":[{"outcome_type":"primary","measure":"Morbidity","time_frame":"Assessed at discharge and will be reported through study completion, an average of 1 year","description":"Number of STS defined complications (chest tube airleak, atelectasis, pleural effusion requiring drain, pneumonia, ARDS, respiratory failure, bronchopleural fistula, PE, pneumothorax, chylothorax, ventilator > 48 hours, tracheostomy, tracheobronchial injury, ileus, anastomotic leak, GI dilation, conduit necrosis requiring surgery, delayed conduit emptying, C. diff, delirium) will be combined to report the number of morbidity events"},{"outcome_type":"primary","measure":"Discharge status","time_frame":"Assessed at discharge and will be reported through study completion, an average of 1 year","description":"Discharge destination"},{"outcome_type":"secondary","measure":"Length of stay","time_frame":"Assessed from date of surgery until the date of discharge and will be reported through study completion, an average of 1 year","description":"Time spent in the hospital during perioperative stay"},{"outcome_type":"secondary","measure":"30 day readmission","time_frame":"Assessed from date of discharge to thirty days after discharge and will be reported through study completion, an average of 1 year","description":"If a patient requires a readmission to the hospital within 30 days of discharge and the reasons for readmission"}]}
{"nct_id":"NCT03384043","start_date":"2018-01-08","phase":"N/A","enrollment":52,"brief_title":"Comparing Smartphone Technology and a Memory Strategy on Improving Prospective Memory in Alzheimer's Disease","official_title":"Using Smartphone Personal Assistant Technology to Improve Prospective Memory in Alzheimer's Disease","primary_completion_date":"2020-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-02-28","last_update":"2020-07-08","description":"Alzheimer's disease is a debilitating condition for patients and their caregivers marked by hallmark cognitive symptoms (e.g., memory loss) as well as an impact on quality of life. Researchers and clinicians are learning that a specific type of memory, called prospective memory, may be particularly affected in mild Alzheimer's disease. Prospective memory is memory for future intentions, goals, and chores, and the loss of the neurocognitive processes supporting prospective memory may reduce independent functioning (e.g., medication adherence). The current study investigates a technology-based intervention to assist participants with their daily prospective memory tasks. Participants with mild cognitive impairment and mild Alzheimer's disease will be trained to use a smartphone for four weeks. Smartphone acceptability, usability, and overall user experience will be measured. Furthermore, participants will be tested on completion of daily prospective memory tasks. In one group, participants will train to use the smartphone personal assistant reminder system, which reminds participants of their goals, tasks, and chores at the appropriate time or location. In a comparison group, participants will also carry a smartphone but will train to use a memory strategy in which they verbalize external cues to remind them to perform their goals, tasks, and chores. The goal of this research is to inform whether smartphone technology or a memory strategy can be used to reduce memory burden and improve daily, independent functioning in participants with mild Alzheimer's disease.","other_id":"017-327","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"Double","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosis of MCI or dementia at a neurology and/or neuropsychology office visit in the\r\n             BSWH Temple region, or neuropsychology office visit in the RR BSWH region within 12\r\n             months of the study contact (Specific ICD Codes outlined below).\r\n\r\n          -  Interest in participating in research\r\n\r\n          -  Able and willing to bring a legally authorized representative (spouse or medical power\r\n             of attorney) to initial training session.\r\n\r\n          -  Able to independently consent according to the results of a structured capacity to\r\n             consent interview OR is interested after going through the consent process but does\r\n             not pass capacity to consent inventory AND has a legally authorized representative\r\n             available to provide proxy consent.\r\n\r\n          -  Presence of no more than mild dementia on the basis of telephone administered\r\n             cognitive screening instrument (TICS-M) & Collateral/Informant ADL Measure\r\n\r\n             o Using the TICS-M and published normative data, all subjects must have scores that\r\n             are around -1 to -2 standard deviations for demographically corrected norms (National\r\n             Institute of Aging-Alzheimer's Association recommended criteria for the very mild to\r\n             mild stages of Alzheimer's disease; Albert et al., 2011; McKhann et al., 2011).\r\n\r\n          -  Etiology of the dementia or MCI can be varied or unknown at the time of the screening\r\n             criteria.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Presence of severe cognitive impairment defined by a TICS-M score <-2 standard\r\n             deviations from the mean.\r\n\r\n          -  Semi-structured telephone clinical interview and/or chart review suggest:\r\n\r\n               -  Serious mental illness (schizophrenia, bipolar, or depression with suicidal\r\n                  ideation in the last 30 days) are present and significantly contributing to the\r\n                  current presentation\r\n\r\n               -  Uncorrected hearing loss, visual loss, or motoric dysfunction would preclude\r\n                  using the smartphone.\r\n\r\n          -  English language proficiency (whether due to English as a second language or the\r\n             presence of aphasia) significantly interferes with completion of telephone screening\r\n             procedures or would be clinically suspected to interfere with completion of the study\r\n             process.\r\n      ","sponsor":"Baylor University","sponsor_type":"Other","conditions":"Alzheimer Disease|Cognitive Impairment, Mild|Dementia, Mild","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Smartphone Personal Assistant","description":"Electronic memory aids (e.g., pagers) are known to support memory for goals and intentions (prospective memory) in individuals with cognitive impairment. Smartphone technology has the potential to enhance the benefits of previous electronic memory aids because they can provide reminders not only at the correct time, but also at the correct location."},{"intervention_type":"Behavioral","name":"Behavioral: Implementation Intention","description":"Verbally specifying when and where one intends to complete a goal or action (prospective memory) is known to improve the likelihood of later completing that prospective memory. The implementation intention is the best known memory strategy for prospective memory in patients with mild cognitive impairment."}],"outcomes":[{"outcome_type":"primary","measure":"Objective Prospective Memory Performance","time_frame":"Measured for 4 weeks.","description":"Performance on the experimenter-assigned time-based and event-based prospective memory tasks (number of tasks completed)."},{"outcome_type":"secondary","measure":"Quality of Life - Positive Affect and Well-Being","time_frame":"Pre-Intervention and Post-Intervention (4 weeks)","description":"Participants will complete the Quality of Life in Neurological Disorders (Neuro-QOL) subscale titled \"Positive Affect and Well-Being.\" This subscale has 9 items that are rated from Never to Always. The subscale total scores range from 9 (minimum) to 45 (maximum), with higher scores indicating better outcomes"},{"outcome_type":"secondary","measure":"Quality of Life - Ability to Participate in Social Roles and Activities","time_frame":"Pre-Intervention and Post-Intervention (4 weeks)","description":"Participants will complete the Quality of Life in Neurological Disorders (Neuro-QOL) subscale titled \"Ability to Participate in Social Roles and Activities.\" This subscale has 8 items that are rated from Never to Always. The subscale total scores range from 8 (minimum) to 40 (maximum), with higher scores indicating better outcomes."},{"outcome_type":"secondary","measure":"Quality of Life - Satisfaction with Social Roles and Activities","time_frame":"Pre-Intervention and Post-Intervention (4 weeks)","description":"Participants will complete the Quality of Life in Neurological Disorders (Neuro-QOL) subscale titled \"Satisfaction with Social Roles and Activities.\" This subscale has 8 items that are rated from Not at All to Very Much. The subscale total scores range from 8 (minimum) to 40 (maximum), with higher scores indicating better outcomes."},{"outcome_type":"secondary","measure":"Quality of Life - Cognitive Function","time_frame":"Pre-Intervention and Post-Intervention (4 weeks)","description":"Participants will complete the Quality of Life in Neurological Disorders (Neuro-QOL) subscale titled \"Cognitive Function.\" This subscale has 8 items. The first four items are rated from Never to Very Often, and the last four items are rated from No Difficulty to Cannot Do. The subscale total scores range from 8 (minimum) to 40 (maximum), with higher scores indicating better outcomes."},{"outcome_type":"secondary","measure":"Subjective Memory Performance Questionnaire","time_frame":"Pre-Intervention and Post-Intervention (4 weeks)","description":"The Prospective and Retrospective Memory Questionnaire uses a 5-point scale to assess the frequency of retrospective and prospective memory failures such as forgetting to take a pill."},{"outcome_type":"secondary","measure":"Perceived Memory Structured Interview","time_frame":"Pre-Intervention and Post-Intervention (4 weeks)","description":"The experimenter will conduct a structured interview session at baseline to determine participants' most important, common, and challenging prospective memory tasks. At follow-up, participants will rate whether each memory issue described at baseline was much worse (1), worse (2), normal (3), better (4), or much better (5) than usual over the last month."},{"outcome_type":"secondary","measure":"Use of Technology/Strategy","time_frame":"Measured for 4 weeks","description":"The number of times the personal assistant feature and voice-recorder system were used."},{"outcome_type":"secondary","measure":"Instrumental Activities of Daily Living","time_frame":"Pre-Intervention and Post-Intervention (4 weeks)","description":"Scale on participants' ability to complete instrumental activities of daily living, such as housekeeping, financing, and medication activities."},{"outcome_type":"secondary","measure":"Smartphone Acceptability/Usability Scale","time_frame":"Pre-Intervention and Post-Intervention (4 weeks)","description":"Scale to assess the acceptability and usability of the smartphone (Ben Zeev et al., 2014). The scale includes 26 items to which participants respond agree, neutral, or disagree, with agree indicating the favorable outcome on 21 items, and disagree indicating the favorable outcome on 5 items."},{"outcome_type":"secondary","measure":"Training Duration","time_frame":"Pre-Intervention","description":"Number of minutes to complete smartphone training"}]}
{"nct_id":"NCT03377218","start_date":"2018-01-05","phase":"N/A","enrollment":300,"brief_title":"Potential Preventive Effect of Selenium on Iodine-induced Thyroid Autoimmunity During Pregnancy","official_title":"Safety and Efficacy of Iodine Supplementation During Pregnancy With and Without Selenium Co-administration: Randomized Controlled Trial","primary_completion_date":"2018-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-01-31","last_update":"2018-04-19","description":"In 1994, the WHO and UNICEF Joint Committee on Health Policy recommended Universal Salt Iodization as a safe, cost-effective and sustainable strategy to ensure sufficient intake of iodine by all individuals. However, it is still absent in Latvia. A recent countrywide study in 2013 shows iodine deficiency among pregnant women in Latvia: 81 % of pregnant women had UIC levels below the WHO recommended range of 150-250 mcg/g Cr. Because mild to moderate iodine deficiency during pregnancy can adversely affect fetal brain development, WHO-UNICEF and ICCIDD advise an increase in the recommended daily dosage of iodine to 250 mcg/day for pregnant women and breastfeeding women and 150 mcg/day for women in the preconception period. Data from a survey of the Latvian population indicate that approximately 100 mcg of iodine per day is consumed through foods and iodized salt. To meet the increased iodine requirement in pregnancy, pregnant women should take a supplement containing 150 mcg of iodine daily from the earliest time possible. A sudden increase in iodine intake in an iodine-deficient population may increase thyroid autoimmunity. It is evident that thyroid disease has multiple adverse effects during pregnancy and in the developing fetus especially in women with elevated serum anti-thyroid antibody titers. Studies have considered supplementing with selenium to reduce the risk of auto-immune thyroiditis/post-partum autoimmune thyroid disease. Of the 11 trials of selenium supplementation in patients with autoimmune thyroiditis, 7 have shown benefit with treatment for 6 months or longer. Aim of study is to approve that 150 mcg of iodine daily improves iodine status in pregnant women and iodine 150 mcg in combination with selenium 100 mcg daily reduce risk of thyroid autoimmunity. Hypothesis of study is that 150 mcg iodine daily during pregnancy improves iodine status. Iodine in combination with selenium is less associated with thyroid autoimmunity. Study design: Pregnant women are randomized for either 150 mcg iodine intake daily or 150 mcg iodine combined with 100 mcg selenium daily. Interventional group is compared with controls without particular iodine supplementation. Participants are asked to complete a questionnaire on dietary habits concerning iodine. Thyroid function (thyroid-stimulating hormone, free thyroxine) and thyroperoxidase antibodies (TPO-Ab) and urinary iodine are measured during first, second and third trimester of pregnancy and week 8 after delivery in both, intervention and control group.","other_id":"RigaStradinsU_Iodine3","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Quadruple","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  healthy women before 10 weeks of gestation\r\n\r\n          -  signed informed consent form\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  pre-existing thyroid disease\r\n\r\n          -  pregnancy after assisted reproductive technologies\r\n\r\n          -  known hypersensitivity reaction to iodine or selenium, or other components of dietary\r\n             supplement used in the study\r\n      ","sponsor":"Riga Stradins University","sponsor_type":"Other","conditions":"Pregnancy|Thyroid Autoimmune Disease|Iodine Deficiency|Selenium Deficiency","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Iodine","description":"Receiving 150 g iodine (as potassium iodide) daily"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Iodine + Selenium","description":"Receiving a combination of 150 g iodine (as potassium iodide) and 100 g selenium daily"}],"outcomes":[{"outcome_type":"primary","measure":"UIC","time_frame":"At baseline - 9/10 weeks of gestation, second sample - 24 weeks of gestation (14 weeks from baseline), third sample - 34 weeks of gestation (24 weeks from the baseline) and fourth sample - 8 weeks postpartum- (38 weeks after the baseline sample)","description":"Urinary iodine concentration"},{"outcome_type":"primary","measure":"Change in anti-TPO Ab","time_frame":"At baseline - 9/10 weeks of gestation, second sample - 24 weeks of gestation (14 weeks from baseline), third sample - 34 weeks of gestation (24 weeks from the baseline) and fourth sample - 8 weeks postpartum- (38 weeks after the baseline sample)","description":"Change in anti-thyroperoxidase antibodies"},{"outcome_type":"secondary","measure":"TSH","time_frame":"At baseline - 9/10 weeks of gestation, second sample - 24 weeks of gestation (14 weeks from baseline), third sample - 34 weeks of gestation (24 weeks from the baseline) and fourth sample - 8 weeks postpartum- (38 weeks after the baseline sample)","description":"Thyroid stimulating hormone"},{"outcome_type":"secondary","measure":"fT4","time_frame":"At baseline - 9/10 weeks of gestation, second sample - 24 weeks of gestation (14 weeks from baseline), third sample - 34 weeks of gestation (24 weeks from the baseline) and fourth sample - 8 weeks postpartum- (38 weeks after the baseline sample)","description":"Free thyroxine"}]}
{"nct_id":"NCT03245437","start_date":"2018-01-04","phase":"Phase 4","enrollment":120,"brief_title":"Target Engagement and Response to Oxytocin","official_title":"Effects of Oxytocin on Social Cognition Training: Relationship to Target Engagement","primary_completion_date":"2022-05-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-10-31","last_update":"2021-02-09","description":"This study will measure whether the engagement of intranasal oxytocin with a brain target is related to effects on learning during a social cognition training program.","other_id":"OT R33","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Schizophrenia or schizoaffective disorder\r\n\r\n          -  stable on an antipsychotic medication\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  positive pregnancy test history of head injury\r\n      ","sponsor":"University of California, Los Angeles","sponsor_type":"Other","conditions":"Schizophrenia","interventions":[{"intervention_type":"Drug","name":"Drug: Oxytocin nasal spray","description":"nasal spray"},{"intervention_type":"Behavioral","name":"Behavioral: Social Cognition Skills Training","description":"Group based training in social cognition skills"},{"intervention_type":"Behavioral","name":"Behavioral: Health Management","description":"Group-based training in mental health management"},{"intervention_type":"Drug","name":"Drug: Placebo nasal spray","description":"placebo condition"}],"outcomes":[{"outcome_type":"primary","measure":"Social Cognition Composite Score","time_frame":"16 weeks","description":"We will assess social cognition in two subdomains: (1) social cue identification (Managing Emotions component of Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) branch 1, Ekman, Profile of Nonverbal Sensitivity (PONS); and (2) mentalizing (The Awareness of Social Inference Test (TASIT). and Empathic accuracy) (see below). The primary summary measure for each test will be mean-centered and standardized to create a Z-score. These Z-scores will be averaged to create a single composite score for social cognition that will serve as the primary outcome measure."},{"outcome_type":"secondary","measure":"Composite score of non-social cognition from the MATRICS Consensus Cognitive Battery","time_frame":"16 weeks","description":"Standardized z-score"}]}
{"nct_id":"NCT03393572","start_date":"2018-01-03","phase":"Phase 4","enrollment":80,"brief_title":"Intraperitoneal Bupivacaine With Magnesium or Nalbuphine for Postoperative Pain Control in Laparoscopic Hysterectomy","official_title":"Intraperitoneal Instillation of Bupivacaine With Either Magnesium Sulphate or Nalbuphine for Postoperative Pain Control in Laparoscopic Hysterectomy: a Prospective, Randomized, Double-blinded Trial.","primary_completion_date":"2018-06-05","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-06-15","last_update":"2019-07-16","description":"The purpose of this study is to compare between the addition of Mg sulphate or Nalbuphine to intraperitoneal bupivacaine installation in laparoscopic hysterectomy for postoperative pain control and their relative adverse effects.","other_id":"FMASU R49/2017","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"Female","minimum_age":20,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  American Society of Anesthesiologists (ASA) physical status I and II\r\n\r\n          -  scheduled for laparoscopic hysterectomy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  ASA physical status more than II\r\n\r\n          -  Obesity (body mass index higher than 30 kg/ m2)\r\n\r\n          -  History of chronic opioids intake\r\n\r\n          -  Known hypomagnesaemia or hypermagnesaemia\r\n\r\n          -  Chronic alcoholism\r\n\r\n          -  Heart block\r\n\r\n          -  Renal failure\r\n\r\n          -  Patients with history of left ventricular failure\r\n\r\n          -  Patients taking beta-blocking drugs\r\n\r\n          -  Allergy to the study drugs\r\n\r\n          -  if surgery changed to open hysterectomy,\r\n      ","sponsor":"Ain Shams University","sponsor_type":"Other","conditions":"Anesthesia","interventions":[{"intervention_type":"Drug","name":"Drug: Bupivacaine 0.25%","description":"Patients will receive 30 mL of intraperitoneal bupivacaine 0.25%"},{"intervention_type":"Drug","name":"Drug: Magnesium sulphate.","description":"Patients will receive intraperitoneal 30 mg/kg of magnesium sulphate."},{"intervention_type":"Drug","name":"Drug: nalbuphine","description":"Patients will receive intraperitoneal 5 mg nalbuphine"}],"outcomes":[{"outcome_type":"primary","measure":"Rescue analgesia time","time_frame":"First 24 hours postoperatively","description":"Time to first analgesia requirment(considering the extubation is the zero time)"},{"outcome_type":"secondary","measure":"Visual analogue scale [VAS]","time_frame":"First 24 hours postoperatively","description":"Visual analogue scale [VAS] will be used to measure pain score at 30 min, 1, 2, 4, 6, 8, 10, 12 and 24 h after surgery. All the study patients will be instructed about the use of the VAS scale before induction of anesthesia (VAS score 0 cm = no pain, VAS score 10 cm = worst possible pain)"},{"outcome_type":"secondary","measure":"Total analgesic consumption","time_frame":"First 24 hours postoperatively","description":"Intravenous diclofenac 75 mg will be given as rescue analgesic when VAS ≥ 4.Total diclofenac consumption will be recorded."}]}
{"nct_id":"NCT03656419","start_date":"2018-01-02","phase":"N/A","enrollment":39,"brief_title":"Photodynamic Therapy With Red Leds in Microorganisms Related to Halitosis","official_title":"Action of Antimicrobial Photodynamic Therapy With Red Leds in Microorganisms Related to Halitose: Clinical Controlled and Randomized Trial","primary_completion_date":"2018-10-24","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2018-12-10","last_update":"2018-09-04","description":"Halitosis is the term used to describe any unpleasant odor relative to expired air regardless of its source. The prevalence of halitosis in the population is approximately 30%, of which 80-90% of the cases originate in the oral cavity resulting from proteolytic degradation by gram negative anaerobic bacteria. Antimicrobial photodynamic therapy (aPDT) has been widely used and with very satisfactory results in the health sciences, it involves the use of a non-toxic dye, called photosensitizer (FS), and a light source of a specific wavelength in the presence of the oxygen in the medium. This interaction, is capable of creating toxic species that generate cell death. The advantages of this approach are to avoid resistance to target bacteria and damage to adjacent tissues as the antimicrobial effect is confined only to areas covered by the dye and irradiated by light acting on the target organism rapidly, depending on the dose of light energy and power output. The objective of this controlled clinical study is to verify the effect of aPDT in the treatment of halitosis by evaluating the formation of volatile sulfur compounds with gas chromatography and microbiological analysis before and after treatment. Will be included in this research young adults in the age group between 18 to 25 years with diagnosis of halitosis. The selected subjects will be divided into 3 groups, G1 aPDT, G2 Scraper and G3 aPDT and scraper. All subjects will be submitted to microbiological analysis and evaluation with Oral ChromaTM before, after treatment and followed up of 7, 14 and 30 days For the evaluation of the association of the categorical variables will be used Chi-square test and Fisher's Exact Test, to compare the means will be used tStudent test and Analysis of variance (ANOVA) and to analyze the correlation between the continuous variables will be applied the correlation test by Pearson. In the analyzes of the experimental differences in each group the Wilcoxon test will be used. For all analyzes a level of significance of 95% (p <0.05) will be considered.","other_id":"Halitose","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"A controlled, quantitative cross-sectional clinical study.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":25,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Included in this study are young adults between the ages of 18 and 25, with an\r\n             informed consent form and authorization for the diagnosis and treatment of halitosis.\r\n\r\n        Young adults diagnosed with halitosis presenting Oralchroma S2H  112 ppb and / or CH3SH \r\n        26.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  With dentofacial anomalies,\r\n\r\n          -  In orthodontic and / or orthopedic treatment,\r\n\r\n          -  Using a removable device, implant and / or prosthesis,\r\n\r\n          -  With periodontal disease,\r\n\r\n          -  With teeth with carious lesions,\r\n\r\n          -  In cancer treatment,\r\n\r\n          -  On antibiotic treatment up to 1 month prior to the survey,\r\n\r\n          -  Pregnant,\r\n\r\n          -  With hypersensitivity to the photosensitizer to be used.\r\n      ","sponsor":"University of Nove de Julho","sponsor_type":"Other","conditions":"Halitosis","interventions":[{"intervention_type":"Procedure","name":"Procedure: photodynamic therapy","description":"aPDT with methylene blue and red led irradiation."},{"intervention_type":"Procedure","name":"Procedure: Tongue scraper","description":"Tongue scraper 10 times from de back to the top."}],"outcomes":[{"outcome_type":"primary","measure":"Clinical Results after treatment with gás chromatography","time_frame":"30 days","description":"If halitosis reduces in patients after treatment"},{"outcome_type":"secondary","measure":"Microbiological Analysis after treatment with qPCR analisys","time_frame":"30 days","description":"If aPDT reduces the microorganism related to halitosis after treatment"}]}
{"nct_id":"NCT03915119","start_date":"2018-01-01","phase":"N/A","enrollment":45,"brief_title":"Fuzzy AI Using VR for Collision Prevention","official_title":"Genetic Fuzzy Artificial Intelligence Driven Virtual Reality for Prevention of Collision-based Injury","primary_completion_date":"2019-02-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-09-30","last_update":"2020-02-07","description":"The purpose of this study is to develop and test a VR training system that integrates GFT AI with virtual obstacle scenarios that, when compared to a sham-VR training system, is hypothesized to increase neuromechanical and perceptual-motor fitness, decrease collision frequency and impact forces for soccer athletes, during a single training session and also when assessed at approximately 1 week and 1 month following training.","other_id":"2017-6006","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":14,"maximum_age":22,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  healthy\r\n\r\n          -  varsity high school or collegiate soccer athlete\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  unable to participate in soccer\r\n\r\n          -  history of congenital or acquired cognitive, ophthalmologic, or neurological disorders\r\n             including developmental delay, brain tumor, stroke, or known peripheral or central\r\n             vestibular disorders\r\n\r\n          -  patients who have begun anti-depressant, stimulant or anti-seizure medications for\r\n             treatment of their symptoms or for other, unrelated reasons within two months of\r\n             testing will be excluded from testing\r\n      ","sponsor":"Children's Hospital Medical Center, Cincinnati","sponsor_type":"Other","conditions":"Injuries","interventions":[{"intervention_type":"Other","name":"Other: GFT AI training","description":"navigates a cluttered environment of stationary and moving/pursuing virtual obstacles to reach a way-point as quickly and efficiently as possible. Block order and difficulty, as well as the behavior of the obstacles in each block, will be driven by the AI and statistically weighted to specifically target the perceptual-motor and neuromechanical mechanisms based on each athlete's visit 1 performance"}],"outcomes":[{"outcome_type":"primary","measure":"Pro-saccades test","time_frame":"10 minutes","description":"Pro-saccades will be tested as participants track discrete target motion that will jump randomly by 14, 16, 18, 20, 22, or 24˚ on the screen in a horizontal and vertical direction, at intervals varying pseudo randomly between 1.0 and 2.0 s. The current fixation target will be extinguished at the same time as the next peripheral target appears. The test sequence will take 30 s/trial (2 trials) and all participants will be instructed to follow the targets as quickly and accurately as possible"},{"outcome_type":"secondary","measure":"Self paced saccades","time_frame":"10 minutes","description":"Self-paced saccades will be assessed as the participant glances back and forth as quickly and accurately as possible between two constantly visual targets at ± 15˚ horizontally from one another. This test will take 30 s per trial and the participant will perform 2 trials."},{"outcome_type":"secondary","measure":"Anti-saccades test","time_frame":"10 minutes","description":"Anti-saccades will be tested as participants are presented discrete targets that jump randomly by 14, 16, 18, 20, 22, or 24˚ on the screen in a horizontal and vertical direction, at intervals varying pseudo randomly between 1.0 and 2.0 s while a cross-hairs is present in the center of the screen. The athletes will be instructed to fixate on the cross-hairs and at the moment each object appears, to saccade in the opposite direction and then return their gaze back to the cross-hairs for the start of the next trial."}]}
{"nct_id":"NCT03453255","start_date":"2018-01-01","phase":"Phase 1/Phase 2","enrollment":120,"brief_title":"DCHA as Postremission Therapy for AML With t(8;21)","official_title":"Decitabine in Combination With Chidamide, Homoharringtonine and Ara-c (DCHA) as Postremission Therapy for Acute Myeloid Leukemia With t(8;21) :A Multicenter Prospective Study","primary_completion_date":"2019-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2020-12-31","last_update":"2018-03-05","description":"Acute myelocytic leukemia ( AML) is a highly heterogeneous group of malignant hematopathy. Chromosomal translocation with t (8; 21) (q22; q22) , about 10 ~ 15% incidence in AML and 40% incidence in the AML-M2 type of leukemia, is a karyotype that is considered to have a good prognosis. The National Comprehensive Cancer Network (NCCN) guidelines recommend that high-dose Ara-c regimens may benefit for patients, but with 30 to 40% relapse and serious risks on myelosuppression, infection and bleeding in high-dose Ara-c consolidation chemotherapy and more than 70% recurrence rate with tyrosine kinaseKIT mutation. So the exploration of a relatively safe and efficient consolidation therapy is one of the difficult problems to be solved in the treatment of mitigatory t (8; 21) AML.","other_id":"301-XYK-004","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":14,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -   Written informed consent provided.\r\n\r\n               -  The patients were diagnosed AML-M2 with t(8;21) (q22;q22) chromosomal changes and\r\n                  positive acute myeloid leukemia(AML1)-eight twenty one(ETO) fusion gene according\r\n                  to the 2008 World Health Organization (WHO) diagnostic criteria for malignant\r\n                  myeloid diseases.\r\n\r\n               -  Males or females aged 18 years, < 65 years.\r\n\r\n               -  Eastern Cooperative Oncology GroupECOG performance status 0-3.\r\n\r\n               -  Life expectancy 3 months.\r\n\r\n               -  The morphology was Complete remission (CR) or Cri after 2 cycles of anthracycline\r\n                  induced chemotherapy.\r\n\r\n               -  No serious disease with heart, lung, liver and kidney.\r\n\r\n               -  The ability to understand and be willing to sign the Informed Consent Form of the\r\n                  experiment.\r\n\r\n               -  Patient who can start the investigational therapy within 3-6 weeks after the\r\n                  complete resection\r\n\r\n               -  Adequate liver function: Total bilirubin  1.5 x upper limit of normal (ULN),\r\n                  Aspartate aminotransferase (AST), alanine aminotransferase (ALT)  2.5 x ULN in\r\n                  subjects without liver metastases;  5 x ULN in subjects with liver metastases.\r\n\r\n               -  Adequate renal function: Serum creatinine  1.25 x ULN, or  60 ml/min.\r\n\r\n               -  Female subjects should not be pregnant or breast-feeding.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Known allergic to prior treatment with drugs contained by the trial programme or with\r\n             a chemical structure similar medicine.\r\n\r\n          -  Pregnancy, breast-feeding women and childbearing age patients who do not want to take\r\n             contraceptive measures.\r\n\r\n          -  Active serious infection.\r\n\r\n          -  Patients with extramedullary lesions.\r\n\r\n          -  Patients who use drugs or drink alcohol for a long time to influence the evaluation of\r\n             results.\r\n\r\n          -  Patients with mental illness or other conditions are unable to obtain knowledge and\r\n             consent, and can not cooperate with the requirements of the completion of the test\r\n             treatment and examination steps.\r\n\r\n          -  Patients with a history of the clinical significance of Q and T intervalQTc\r\n             prolongation (male > 450ms, female >470ms), ventricular tachycardia (VT), atrial\r\n             fibrillation (AF), degree of heart block, muscle infarction (MI) within 1 years,\r\n             congestive heart failure (CHF), with symptoms and drug therapy in patients with\r\n             coronary heart disease.\r\n\r\n          -  Patients with abnormal liver function (total bilirubin > 1.5 x ULN, ALT/AST > 2.5 x\r\n             ULN, or liver invasion ALT/AST > 5x ULN ), renal function abnormality (serum\r\n             creatinine > 1.5 x ULN).\r\n\r\n          -  The researchers decided that patient was not appropriate to take part in the\r\n             experiment.\r\n      ","sponsor":"Chinese PLA General Hospital","sponsor_type":"Other","conditions":"Chemotherapy","interventions":[{"intervention_type":"Drug","name":"Drug: Chemotherapy","description":"chidamide, decitabine, homoharringtonine, cytarabine"}],"outcomes":[{"outcome_type":"primary","measure":"Progression free survival","time_frame":"2 years","description":"To evaluate the disease progression free survival of DCHA as postremission therapy for acute myeloid leukemia with t(8;21) . Progression free survival (PFS)- defined as the time from remission for the first time to the first documented disease progression."},{"outcome_type":"secondary","measure":"Overall survival","time_frame":"2 years","description":"Overall survival (OS)- defined as the length of time from trial treatment to death."}]}
{"nct_id":"NCT03265795","start_date":"2018-01-01","phase":"N/A","enrollment":8,"brief_title":"Validity of PEEK PSI Containing Autogenous Bone Graft for Maxillary Reconstruction Following Lesion Enucleation","official_title":"Validity of PEEK PSI Containing Autogenous Bone Graft for Maxillary Reconstruction Following Lesion Enucleation","primary_completion_date":"2018-03-01","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2018-07-01","last_update":"2017-08-30","description":"Surgical ablation of large maxillary cysts usually results in considerable hard and soft tissue deficits that ultimately affect the final esthetic and functional outcomes. Reconstruction of such defects; whether primarily or secondarily; offers much better long-term outcomes. However, primary bony reconstruction becomes potentially complicated in many cases of such large cysts encroaching or involving the maxillary sinus where a communication with the maxillary sinus lining may be unavoidable. Reconstruction of such defects can be accomplished using either vascularized or; more commonly; non-vascularized autogenous bone grafts. Different bone substitutes remain to be another viable option. The simultaneous use of titanium meshes provides physical three-dimensional support for the bone graft contained within as well as the overlying soft tissues. However, the drawbacks of titanium meshes in such defects remain to be mainly the difficulty in adequately shaping the mesh and the lack of proper isolation of the mesh contents from the maxillary sinus cavity.","other_id":"maxillary reconstruction","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":15,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age of patients from 15 to 60 years old.\r\n\r\n          2. Patients with unilateral maxillary lesion encroaching maxillary sinus.\r\n\r\n          3. Dentulous or edentulous patients.\r\n\r\n          4. Patients should be free from any systemic disease that may affect normal healing of\r\n             bone and predictable outcome.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients with systemic diseases as history of radiation therapy or chemotherapy,\r\n             hematological disorders, neuromotor disorders and autoimmune diseases (may affect\r\n             normal healing).\r\n\r\n          2. Patients with bilateral maxillary lesions.\r\n\r\n          3. Children under 15 years old.\r\n      ","sponsor":"Cairo University","sponsor_type":"Other","conditions":"Maxillary Cyst","interventions":[{"intervention_type":"Device","name":"Device: Poly Ether Ether Ketone PSI (patient specific implant).","description":"reconstruction of the bone and the original volume of maxillary sinus accurately (in terms of clinical and radiographic parameters)."}],"outcomes":[{"outcome_type":"primary","measure":"oral health related quality of life","time_frame":"4 months","description":"OHIP-49 questionaire"}]}
{"nct_id":"NCT04648332","start_date":"2018-01-01","phase":"N/A","enrollment":90,"brief_title":"Compartment Psoas Block Efficacy and Safety","official_title":"Compartment Psoas Block Efficacy and Safety for Perioperative Analgesia in the Elderly With Proximal Femur Fractures: a Randomized Controlled Study","primary_completion_date":"2019-08-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-08-30","last_update":"2020-12-01","description":"A randomized controlled trial to assess the efficacy and safety of the prolonged compartment psoas block for analgesia and anesthesia for femur surgery in the elderly","other_id":"H35LP44qr9","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        -proximal femur fracture\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  pregnancy and lactation\r\n\r\n          -  history of opiate addiction\r\n\r\n          -  traumatic brain injury\r\n\r\n          -  acute cerebrovascular accident\r\n\r\n          -  chronic heart failure (New York Heart Association Functional Classification, NYHA,\r\n             class III-IV)\r\n\r\n          -  respiratory failure\r\n\r\n          -  renal failure with decreased creatinine clearance less than 30 ml / min / 1.73 m2\r\n\r\n          -  hepatic insufficiency class C according to Child-Pugh).\r\n      ","sponsor":"Bogomolets National Medical University","sponsor_type":"Other","conditions":"Femur Fracture","interventions":[{"intervention_type":"Drug","name":"Drug: Bupivacaine Hydrochloride","description":"compartment psoas block"}],"outcomes":[{"outcome_type":"primary","measure":"postoperative nalbuphine consumption during first 24 hours and cumulative during hospital stay","time_frame":"72 hours","description":"postoperative nalbuphine consumption during first 24 hours and cumulative during hospital stay"},{"outcome_type":"secondary","measure":"ICU length of stay and the total duration of hospitalization","time_frame":"102 hours","description":"ICU length of stay and the total duration of hospitalization"},{"outcome_type":"secondary","measure":"number of patients who had severe pain after surgery","time_frame":"72 hours","description":"number of patients who had severe pain after surgery"},{"outcome_type":"secondary","measure":"incidence of on-demand analgesia","time_frame":"72 hours","description":"incidence of on-demand analgesia"}]}
{"nct_id":"NCT03467295","start_date":"2018-01-01","enrollment":2000,"brief_title":"Treatments and Outcomes of Untreated Cerebral Cavernous Malformations in CHina.","official_title":"Treatments and Outcomes of Untreated Cerebral Cavernous Malformations in CHINA (TOUCH): A Nationwide Multicenter Prospective Cohort Study.","primary_completion_date":"2023-03-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2023-03-31","last_update":"2018-03-19","description":"This nationwide multicenter prospective cohort study will collect the treatment information and outcomes of the patients with previously untreated cavernous malformations (U-CMs) in China (at least 2000 patients from 20 centers). The investigators aim to determine the effect of different treatments on long-term outcomes in patients with untreated cerebral cavernous malformations.","other_id":"FAHFMU-2018-003","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","population":"Consecutive patients with untreated cerebral cavernous malformation are enrolled from 20\r\n        Grade  A level hospitals distributed all over China. At the time of the participants\r\n        entered the study, lesions should not have been treated by surgery or radiosurgery\r\n        previously. This is a cohort follow-up study across a 5-year period. All patients in this\r\n        study should meet the inclusion and exclusion criteria. Informed written consent should be\r\n        obtained from eligible adult patients or from the guardians of eligible pediatric patients.\r\n        All patients in the prospective part of this study can withdraw at any time.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Definite diagnosis of cerebral CM on the basis of brain MRI or pathologic examination;\r\n\r\n          -  Patients without any surgical intervention (microsurgery, radiosurgery, or\r\n             multimodality treatment) before enrolment;\r\n\r\n          -  Informed consent, and willing to accept long-term follow-up.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients receiving emergency surgery due to acute intracranial hematoma and resultant\r\n             brain hernia;\r\n\r\n          -  Patients with other never system diseases, such as aneurysms, tumors or other vascular\r\n             malformations except venous development anomaly;\r\n\r\n          -  Patients with severe underlying disease, which affects the patient's functional status\r\n             and life expectancy;\r\n\r\n          -  Patients with severe mental or psychologic disease.\r\n      ","sponsor":"First Affiliated Hospital of Fujian Medical University","sponsor_type":"Other","conditions":"Cerebral Cavernous Malformations","interventions":[{"intervention_type":"Procedure","name":"Procedure: Surgery","description":"For patient in surgically treated group, surgical removal of intracerebral CMs by craniotomy is performed according to the principles as follows: less transgression of normal brain tissue; identification and protection of eloquent brain tissue; sparing associated developmental venous anomaly; hemosiderin rim resection for non-eloquent and superficial CMs and sparing yellowish tissue for eloquent and deep ones; Extended resections (mesial resection, standard temporal lobe resection) are recommend for epileptogenic CMs based on intra-operative EEG."},{"intervention_type":"Procedure","name":"Procedure: Observation","description":"Observation is performed in conservatively treated patients with best medicine and supportive treatment, such as antiepileptic drugs, analgesic drugs and neurotrophic drugs. For patients with underlying diseases such as hypertension, hyperlipidemia or diabetes mellitus, after consulting with the relevant experts, the patients can be treated accordingly."}],"outcomes":[{"outcome_type":"primary","measure":"Poor outcome","time_frame":"3 years","description":"The primary outcome of this study is patients with poor outcome (mRS>2 lasting at least 1year) at the last follow up."},{"outcome_type":"secondary","measure":"symptomatic hemorrhage","time_frame":"3 years","description":"Requiring acute or subacute onset symptoms (any of headache, epileptic seizure, impaired consciousness, or new/worsened brain function deficit referable to the anatomic location of the CM) accompanied by radiological, pathological, surgical, or rarely only cerebrospinal fluid evidence of recent extra- or intralesional hemorrhage."},{"outcome_type":"secondary","measure":"drug refractory epilepsy","time_frame":"3 years","description":"Failure of adequate trials of two tolerated, appropriately chosen and used antiepileptic drug schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom."},{"outcome_type":"secondary","measure":"All-cause mortality","time_frame":"3 years","description":"Death caused by all the causes"}]}
{"nct_id":"NCT03616119","start_date":"2018-01-01","enrollment":1000,"brief_title":"Gastroesophageal Reflux Disease in Azerbaijan","official_title":"The Prevalence of Gastroesophageal Reflux Disease in Azerbaijan","primary_completion_date":"2019-08-01","study_type":"Observational [Patient Registry]","rec_status":"Unknown status","completion_date":"2019-09-01","last_update":"2019-08-30","description":"To evaluate the prevalence of Gastroesophageal reflux disease in Azerbaijan. It is intended to evaluate the prevalence of the disease in the regions as well as the capital by cluster sampling ,ethitology and to compare the outcomes depending on the geographical location.","other_id":"QastroHep","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":80,"population":"Azerbaijan is divided by clusters with a definite numbers of individuals to take survey on\r\n        reflux disease in the given age range and calculated by proportion of males and females.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age: 18-80\r\n\r\n          -  Both genders\r\n\r\n          -  Hearburn\r\n\r\n          -  Belching\r\n\r\n          -  Regurgitation\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  protom pomp inhibitor use\r\n\r\n          -  antibiotic use in the last 4 weeks\r\n\r\n          -  upper GI surgery\r\n      ","sponsor":"Sevda Aghayeva","sponsor_type":"Other","conditions":"Gastroesophageal Reflux Disease","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"GER questionnaire (GERQ) of Mayo case 1998- 019","time_frame":"1 year","description":"Observational study"}]}
{"nct_id":"NCT04032275","start_date":"2018-01-01","enrollment":400,"brief_title":"Correlation Between Virus and Biochemical Characteristics and Liver Histological Damage in Untreated Chronic HBV Infection","official_title":"Correlation Between Virus and Biochemical Characteristics and Liver Histological Damage in Untreated Patients With Chronic HBV Infection","primary_completion_date":"2018-12-30","study_type":"Observational","rec_status":"Completed","completion_date":"2018-12-30","last_update":"2019-07-25","description":"This study is a retrospective study. Enrollment study. Enrolled in the Department of Hepatology, Beijing Ditan Hospital, Capital Medical University, Department of Liver Histology, Department of Hepatology, Chronic HBV HBV infection. The data collected included patient gender, . The data collected included patient gender, . The data collected included the patient's gender, age, HBV age of infection, past family history, etc., the age of the collected subjects, the current family history, etc., the liver histopathological diagnosis information collected in the group, and the liver disease examination Clinical toxicities and indicators, including serological diagnostic information, clinical toxicities and indicators for liver disease tests, including serological diagnostic information, clinical toxicities and indicators for liver disease tests, including serum HBV DNA HBV DNAHBV DNAHBV DNA HBV DNA content, HBsAg/HBsAg/HBsAg/HBsAg/anti-HBsHBsHBs, HBeAg/HBeAg/HBeAg/HBeAg/HBeAg/anti-HBe content, biochemical indicators coagulation function and routine data. Content, biochemical indicators, coagulation function and routine data. Content, biochemical indicators, coagulation function and routine data. Observe patient demographic data, HBV DNA HBV DNAHBV DNAHBV DNA HBV DNA content, HBsAg/HBsAg/HBsAg/HBsAg/HBsAg/anti-HBsHBsHBs, HBeAg/HBeAg/HBeAg/HBeAg/HBeAg/HBeAg/anti-HBe HBe content, biochemical indicators, coagulation Correlation between function and routine, coagulation function and conventional indicators and liver histological changes. Explore the relevance of effective diagnosis of liver changes. To explore the characteristics of clinical indicators that can effectively diagnose liver histopathological changes, and to provide clinical indicators for patients with chronic hepatitis B to receive timely treatment of histopathological changes, and provide important evidence for patients with chronic hepatitis B to receive timely treatment.","other_id":"DTXY020","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":65,"population":"Patients with chronic HBVHBVHBV infection: all meet the diagnostic criteria of China's\r\n        Guidelines for the Prevention and Treatment of Chronic Hepatitis B (: all meet the\r\n        diagnostic criteria for the Chinese Guidelines for the Prevention and Treatment of Chronic\r\n        Hepatitis B (2015), HBsAg HBsAg HBsAg positive for 6 months Month;","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  1) Age between 18 and over 65;\r\n\r\n          -  2) gender is not limited;\r\n\r\n          -  3) Patients with chronic HBVHBVHBV infection: all meet the diagnostic criteria of\r\n             China's Guidelines for the Prevention and Treatment of Chronic Hepatitis B (: all meet\r\n             the diagnostic criteria for the Chinese Guidelines for the Prevention and Treatment of\r\n             Chronic Hepatitis B (2015), HBsAg HBsAg HBsAg positive for 6 months Month;\r\n\r\n          -  4) Sign the written informed consent.Exclusion Criteria:\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  1) Combine other hepatitis viruses (HCV (HCV, HDV, HDV) infection;\r\n\r\n          -  2) autoimmune liver disease;\r\n\r\n          -  3) HIVHIV HIV infection;\r\n\r\n          -  4) long-term alcohol abuse and / or other liver damage drugs;\r\n\r\n          -  5) mental illness;\r\n\r\n          -  6) Evidence of liver tumors (cancer or AFP AFP>100 ng/ml 100 ng/ml 100 ng/ml 100\r\n             ng/ml);\r\n\r\n          -  7) decompensated cirrhosis.\r\n      ","sponsor":"Beijing Ditan Hospital","sponsor_type":"Other","conditions":"Chronic Hepatitis B","interventions":[{"intervention_type":"Other","name":"Other: Chronic hepatitis B infection","description":"Chronic hepatitis B infection patients"}],"outcomes":[{"outcome_type":"primary","measure":"the diagnostic ability of clinical indicators","time_frame":"6 months","description":"Clinical indicators characterize the diagnostic ability of liver histology inflammation and fibrosis"}]}
{"nct_id":"NCT02636283","start_date":"2017-12-31","phase":"Phase 2","enrollment":6,"brief_title":"Use of Entresto Sacubitril/Valsartan for the Treatment of Peripheral Arterial Disease","official_title":"Use of Entresto (Sacubitril/Valsartan) for the Treatment of Peripheral Arterial Disease","primary_completion_date":"2018-11-01","study_type":"Interventional","rec_status":"Terminated","completion_date":"2018-11-01","last_update":"2019-12-17","description":"This study proposes the use of Entresto (sacubitril/valsartan) to test the effects on pain free walking duration on patients with peripheral arterial disease, a condition caused by decreased blood flow to the muscles in the legs.","other_id":"15SDG25360025","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Subject with symptoms of intermittent claudication, such as exercise-induced pain,\r\n             cramps, fatigue, or other equivalent discomfort, involving large muscle groups of the\r\n             leg(s) (calf, thigh, buttocks), relieved by rest.\r\n\r\n          2. Ankle-brachial index  0.90 acquired according to the American Heart Association\r\n             guidelines.\r\n\r\n          3. Highest ankle pressure reduced by at least 25 mm Hg after exercise compared to resting\r\n             pressure (or loss of previously present Doppler signal for both the posterior tibial\r\n             and anterior tibial arteries immediately after exercise if arteries were\r\n             incompressible).\r\n\r\n          4. Patients on medical treatment for PAD without significant improvement in intermittent\r\n             claudication within the last 6 months.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Age < 18 and > 80 years.\r\n\r\n          2. Patients with physician diagnosed chronic kidney disease or heart failure stage II or\r\n             IV or unstable angina.\r\n\r\n          3. Echocardiographic evidence of cardiomyopathies and pulmonary hypertension.\r\n\r\n          4. Patients that have received cancer treatment within the last year (except skin\r\n             cancer).\r\n\r\n          5. Severe limitations in mobility due to osteomuscular disorders present at time of\r\n             interview.\r\n\r\n          6. Dementia or other mental disorders that prevent patients from following a research\r\n             protocol present at time of interview\r\n\r\n          7. Patients engaged in an exercise rehabilitation program within the past 6 months.\r\n\r\n          8. Patients schedule to undergo an arterial revascularization procedure during the study\r\n             or have undergone one within the past 6 months.\r\n\r\n          9. Inconsistent maximal walking distance on the treadmill test.\r\n      ","sponsor":"University of Minnesota","sponsor_type":"Other","conditions":"Peripheral Arterial Disease","interventions":[{"intervention_type":"Drug","name":"Drug: Entresto","description":"Oral pills"},{"intervention_type":"Drug","name":"Drug: Placebo group","description":"The placebo pills"}],"outcomes":[{"outcome_type":"primary","measure":"Treadmill Walk Until Pain Initiated in Minutes","time_frame":"12 weeks","description":"Time in minutes on a standardized treadmill test to initiation of pain and time until pain requires patient to stop walking"},{"outcome_type":"secondary","measure":"Mitochondrial and Microvascular Function Arterial Elasticity","time_frame":"12 weeks","description":"Post-contraction measures of mitochondrial and microvascular function using MR spectroscopy and functional MRI"},{"outcome_type":"secondary","measure":"Insulin Sensitivity","time_frame":"12 weeks","description":"Using Homeostasis Model Assessment (HOMA) index"},{"outcome_type":"secondary","measure":"Arterial Elasticity","time_frame":"12 weeks","description":"Pulse wave pressure analysis"},{"outcome_type":"secondary","measure":"Quality of Life Questionnaires","time_frame":"12 weeks","description":"Questionnaires describing independent living and quality of life"}]}
{"nct_id":"NCT03347539","start_date":"2017-12-31","enrollment":300,"brief_title":"Implants on Mobile Health Unit","official_title":"Adolescent Uptake of Implants on a Mobile Health Unit","primary_completion_date":"2019-12-31","study_type":"Observational","rec_status":"Not yet recruiting","completion_date":"2021-12-31","last_update":"2017-11-20","description":"This study explores reasons why adolescents choose to receive a nexplanon implant and remove a Nexplanon implant. Nexplanon is provided as part of the standard of care on the University of Chicago mobile health unit. This study explores reasons for implantation and removal of Nexplanon on this mobile health unit.","other_id":"IRB17-0233","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"Female","minimum_age":14,"maximum_age":19,"population":"The study population will be adolescent females seeking reproductive healthcare on a mobile\r\n        health unit.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Be biologically female\r\n\r\n          -  Be seeking reproductive healthcare on a mobile health unit\r\n\r\n          -  Be interested in receiving Nexplanon for birth control.\r\n\r\n          -  Be between 14 and 19 years of age.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Be biologically male\r\n\r\n          -  Be 13 and younger or 20 and older.\r\n      ","sponsor":"University of Chicago","sponsor_type":"Other","conditions":"Contraception","interventions":[{"intervention_type":"Device","name":"Device: Nexplaon","description":"This study is an exploratory study of user reasons for Nexplanon implant and removal, and NOT a study on the efficacy or safety of Nexplanon. Nexplanon has already been FDA approved and its efficacy and safety studied."}],"outcomes":[{"outcome_type":"primary","measure":"Reasons for choosing Nexplanon","time_frame":"One time, immediately before receiving implant.","description":"Information will be collected through a survey regarding why adolescents choose to receive Nexplanon."},{"outcome_type":"secondary","measure":"Reasons for choosing to remove Nexplanon","time_frame":"One time, immediately before removing implant.","description":"Information will be collected through a survey regarding why adolescents choose to remove Nexplanon."}]}
{"nct_id":"NCT03372538","start_date":"2017-12-31","enrollment":1000,"brief_title":"Multidisciplinary Team in Management of Placenta Accreta","official_title":"is There Any Superior Benefit of Multidisciplinary Team in Management of Placenta Accreta","primary_completion_date":"2018-03-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2018-03-31","last_update":"2017-12-13","description":"comparative study between the incidence of urological injury in case of placenta accreta in cases where urological surgical staff are participating in the operation from the start and in cases where the operation is carried by the gynecological staff only","other_id":"494608","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"Female","minimum_age":20,"maximum_age":40,"population":"1000 patients pregnant 38 weeks with placenta accreta","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  pregnant 38 weeks\r\n\r\n          -  placenta accreta\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  medical disorders complicating pregnancy\r\n      ","sponsor":"Kasr El Aini Hospital","sponsor_type":"Other","conditions":"Placenta Accreta","interventions":[{"intervention_type":"Procedure","name":"Procedure: cesarean section or cesarean hysterectomy","description":"upper segment cesarean section and or cesarean hysteroctomy"}],"outcomes":[{"outcome_type":"primary","measure":"urological injury","time_frame":"intraoperative","description":"badder or ureteric injury"}]}
{"nct_id":"NCT03197584","start_date":"2017-12-31","phase":"Phase 1/Phase 2","enrollment":0,"brief_title":"QUILT-3.051: NANT Ovarian Cancer Vaccine: Combination Immunotherapy in Subjects With Epithelial Ovarian Cancer Who Have Progressed on or After Standard-of-care (SoC) Therapy","official_title":"NANT Ovarian Cancer Vaccine: Combination Immunotherapy in Subjects With Epithelial Ovarian Cancer Who Have Progressed on or After Standard-of-care (SoC) Therapy","primary_completion_date":"2019-02-28","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2019-04-30","last_update":"2021-03-18","description":"This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with epithelial ovarian cancer who have progressed on or after SoC therapy.","other_id":"QUILT-3.051","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age  18 years.\r\n\r\n          2. Able to understand and provide a signed informed consent that fulfills the relevant\r\n             IRB or Independent Ethics Committee (IEC) guidelines.\r\n\r\n          3. Histologically-confirmed epithelial ovarian cancer that has progressed on or after SoC\r\n             therapy. Germ cell, stromal, and borderline ovarian tumors are not allowed.\r\n\r\n          4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\r\n\r\n          5. Have at least 1 measurable lesion of  1.5 cm.\r\n\r\n          6. Must have a tumor biopsy specimen following the conclusion of the most recent\r\n             anticancer treatment. If a historic specimen is not available, the subject must be\r\n             willing to undergo a biopsy during the screening period.\r\n\r\n          7. Must be willing to provide blood samples and, if considered safe by the Investigator,\r\n             a tumor biopsy specimen at 8 weeks after the start of treatment.\r\n\r\n          8. Ability to attend required study visits and return for adequate follow-up, as required\r\n             by this protocol.\r\n\r\n          9. Agreement to practice effective contraception for female subjects of child-bearing\r\n             potential and non-sterile males. Female subjects of child-bearing potential must agree\r\n             to use effective contraception for up to 1 year after completion of therapy, and\r\n             non-sterile male subjects must agree to use a condom for up to 4 months after\r\n             treatment.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. History of persistent grade 2 or higher (CTCAE Version 4.03) hematologic toxicity\r\n             resulting from previous therapy.\r\n\r\n          2. Within 5 years prior to first dose of study treatment, any evidence of other active\r\n             malignancies or brain metastasis except for controlled basal cell carcinoma; prior\r\n             history of in situ cancer (eg, breast, melanoma, and cervical); and bulky ( 1.5 cm)\r\n             disease with metastasis in the central hilar area of the chest and involving the\r\n             pulmonary vasculature.\r\n\r\n          3. Serious uncontrolled concomitant disease that would contraindicate the use of the\r\n             investigational drug used in this study or that would put the subject at high risk for\r\n             treatment-related complications.\r\n\r\n          4. Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's\r\n             disease, autoimmune disease associated with lymphoma).\r\n\r\n          5. History of organ transplant requiring immunosuppression.\r\n\r\n          6. History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative\r\n             colitis).\r\n\r\n          7. Requires whole blood transfusion to meet eligibility criteria.\r\n\r\n          8. Inadequate organ function, evidenced by the following laboratory results:\r\n\r\n               1. White blood cell (WBC) count < 3,000 cells/mm3\r\n\r\n               2. Absolute neutrophil count < 1,500 cells/mm3.\r\n\r\n               3. Platelet count < 100,000 cells/mm3.\r\n\r\n               4. Hemoglobin < 9 g/dL.\r\n\r\n               5. Total bilirubin greater than the upper limit of normal (ULN; unless the subject\r\n                  has documented Gilbert's syndrome).\r\n\r\n               6. Aspartate aminotransferase (AST [SGOT]) or alanine aminotransferase (ALT [SGPT])\r\n                  > 2.5  ULN (> 5  ULN in subjects with liver metastases).\r\n\r\n               7. Alkaline phosphatase (ALP) levels > 2.5  ULN (> 5  ULN in subjects with liver\r\n                  metastases, or >10  ULN in subjects with bone metastases).\r\n\r\n               8. Serum creatinine > 2.0 mg/dL or 177 mol/L.\r\n\r\n               9. International normalized ratio (INR), activated partial thromboplastin time\r\n                  (aPTT), or partial thromboplastin time (PTT) >1.5  ULN (unless on therapeutic\r\n                  anti-coagulation).\r\n\r\n          9. Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg) or\r\n             clinically significant (ie, active) cardiovascular disease, cerebrovascular\r\n             accident/stroke, or myocardial infarction within 6 months prior to first study\r\n             medication; unstable angina; congestive heart failure of New York Heart Association\r\n             grade 2 or higher; or serious cardiac arrhythmia requiring medication.\r\n\r\n         10. Dyspnea at rest due to complications of advanced malignancy or other disease requiring\r\n             continuous oxygen therapy.\r\n\r\n         11. Positive results of screening test for human immunodeficiency virus (HIV), hepatitis B\r\n             virus (HBV), or hepatitis C virus (HCV).\r\n\r\n         12. Current chronic daily treatment (continuous for > 3 months) with systemic\r\n             corticosteroids (dose equivalent to or greater than 10 mg/day methylprednisolone),\r\n             excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic\r\n             reaction or anaphylaxis in subjects who have known contrast allergies is allowed.\r\n\r\n         13. Known hypersensitivity to any component of the study medication(s).\r\n\r\n         14. Subjects taking any medication(s) (herbal or prescribed) known to have an adverse drug\r\n             reaction with any of the study medications.\r\n\r\n         15. Concurrent or prior use of a strong cytochrome P450 (CYP)3A4 inhibitor (including\r\n             ketoconazole, itraconazole, posaconazole, clarithromycin, indinavir, nefazodone,\r\n             nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole, and grapefruit\r\n             products) or strong CYP3A4 inducers (including phenytoin, carbamazepine, rifampin,\r\n             rifabutin, rifapentin, phenobarbital, and St John's Wort) within 14 days before study\r\n             day 1.\r\n\r\n         16. Concurrent or prior use of a strong CYP2C8 inhibitor (gemfibrozil) or moderate CYP2C8\r\n             inducer (rifampin) within 14 days before study day 1.\r\n\r\n         17. Participation in an investigational drug study or history of receiving any\r\n             investigational treatment within 14 days prior to screening for this study.\r\n\r\n         18. Assessed by the Investigator to be unable or unwilling to comply with the requirements\r\n             of the protocol.\r\n\r\n         19. Concurrent participation in any interventional clinical trial.\r\n\r\n         20. Pregnant and nursing women.\r\n      ","sponsor":"ImmunityBio, Inc.","sponsor_type":"Industry","conditions":"Ovarian Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Paclitaxel","description":"5,20-Epoxy-1,2,4,7,10,13-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine"},{"intervention_type":"Drug","name":"Drug: Leucovorin","description":"Calcium N-[p-[[[(6RS)-2-amino-5-formyl-5,6,7,8-tetrahydro-4-hydroxy-6-pteridinyl]methyl]amino]benzoyl]-L-glutamate (1:1)"},{"intervention_type":"Drug","name":"Drug: omega-3 acid ethyl esters","description":"omega-3 acid ethyl esters"},{"intervention_type":"Biological","name":"Biological: Avelumab","description":"Fully human anti-PD-L1 IgG1 lambda monoclonal antibody"},{"intervention_type":"Biological","name":"Biological: Bevacizumab","description":"Recombinant human anti-VEGF IgG1 monoclonal antibody"},{"intervention_type":"Drug","name":"Drug: Capecitabine","description":"5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine"},{"intervention_type":"Drug","name":"Drug: Cyclophosphamide","description":"2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate"},{"intervention_type":"Drug","name":"Drug: 5-fluorouracil","description":"5-fluoro-2,4 (1H,3H)-pyrimidinedione"},{"intervention_type":"Drug","name":"Drug: Fulvestrant","description":"7-alpha-[9-(4,4,5,5,5-pentafluoropentylsulphinyl) nonyl]estra-1,3,5-(10)- triene-3,17-beta-diol"},{"intervention_type":"Drug","name":"Drug: Oxaliplatin","description":"cis-[(1 R,2 R)-1,2-cyclohexanediamine-N,N'] [oxalato(2-)- O,O'] platinum"},{"intervention_type":"Radiation","name":"Radiation: Stereotactic Body Radiation Therapy","description":"Stereotactic Body Radiation Therapy (SBRT)"},{"intervention_type":"Biological","name":"Biological: ALT-803","description":"Recombinant human super agonist IL-15 complex"},{"intervention_type":"Biological","name":"Biological: ETBX-021","description":"Ad5 [E1-, E2b-]-HER2 vaccine"},{"intervention_type":"Biological","name":"Biological: ETBX-051","description":"Ad5 [E1-, E2b-]-Brachyury vaccine"},{"intervention_type":"Biological","name":"Biological: ETBX-061","description":"Ad5 [E1-, E2b-]-MUC1 vaccine"},{"intervention_type":"Biological","name":"Biological: GI-4000","description":"Heat-killed S. cerevisiae yeast expressing the mutated RAS oncoproteins"},{"intervention_type":"Biological","name":"Biological: GI-6301","description":"Heat-killed S. cerevisiae yeast expressing the human Brachyury (hBrachyury) oncoprotein"},{"intervention_type":"Biological","name":"Biological: haNK","description":"NK-92 [CD16.158V, ER IL-2]"}],"outcomes":[{"outcome_type":"secondary","measure":"ORR by irRC","time_frame":"1 year","description":"Phase 1b secondary endpoint"},{"outcome_type":"secondary","measure":"Overall survival (OS): time from the date of first treatment to the date of death (any cause)","time_frame":"2 years","description":"Phase 1b and 2 secondary endpoint"},{"outcome_type":"primary","measure":"ORR by Immune-related response criteria (irRC )","time_frame":"1 year","description":"Phase 2 primary endpoint"},{"outcome_type":"secondary","measure":"ORR by RECIST Version 1.1","time_frame":"1 year","description":"Phase 1b secondary endpoint"},{"outcome_type":"secondary","measure":"Progression-free survival (PFS) by RECIST Version 1.1","time_frame":"2 years","description":"Phase 1b and 2 secondary endpoint"},{"outcome_type":"secondary","measure":"PFS by irRC","time_frame":"2 years","description":"Phase 1b and 2 secondary endpoint"},{"outcome_type":"primary","measure":"Incidence of treatment-emergent adverse events (AEs) and serious AE (SAEs), graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03.","time_frame":"1 year","description":"Phase 1b primary endpoint"},{"outcome_type":"primary","measure":"Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1","time_frame":"1 year","description":"Phase 2 primary endpoint"},{"outcome_type":"secondary","measure":"Duration of response (DR): time from the date of first response (partial response (PR) or complete response (CR)) to the date of disease progression or death (any cause) whichever occurs first","time_frame":"2 years","description":"Phase 1b and 2 secondary endpoint"},{"outcome_type":"secondary","measure":"Disease control rate (DCR): confirmed complete response, partial response, or stable disease lasting for at least 2 months","time_frame":"2 years","description":"Phase 1b and 2 secondary endpoint"},{"outcome_type":"secondary","measure":"Quality of life (QoL) by patient-reported outcome using the Functional Assessment of Cancer Therapy-Ovarian Cancer (FACT-O) questionnaire","time_frame":"2 years","description":"Phase 1b and 2 secondary endpoint"},{"outcome_type":"secondary","measure":"Incidence of treatment-emergent AEs and SAEs, graded using the NCI CTCAE Version 4.03","time_frame":"1 year","description":"Phase 2 secondary endpoint"}]}
{"nct_id":"NCT03390010","start_date":"2017-12-28","phase":"Phase 1","enrollment":300,"brief_title":"Misoprostol Versus Active Management of Labour in CS","official_title":"Intrauterine Misoprostol With Active Management of Labour Versus Active Management of Labour for Prevebtion of Postpartum Hemorage in Cesarean Section ,Randomized Controlled Trial","primary_completion_date":"2018-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-06-06","last_update":"2018-08-06","description":"Several treatment strategies are emplemented to prevent post delivery hemorage and decreasing maternal morbidity and mortality .","other_id":"Active management of labour","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":42,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -   All patients included in this research were aged 18-42 years, BMI 20-30,\r\n\r\n               -  no medical disorders with pregnancy e.g DM, HTN. All patients were subjected to\r\n                  full history taking, examination.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Exclusion Criteria:\r\n\r\n               -  The following patients were excluded ,medical disorders with pregnancy eg. DM\r\n                  with pregnancy, HTN with pregnancy\r\n      ","sponsor":"Aljazeera Hospital","sponsor_type":"Other","conditions":"Cesarean Section","interventions":[{"intervention_type":"Drug","name":"Drug: Misoprostol + syntocinon and methergine drugs","description":"medical prophylaxis against postpartum atony and postpartum hemorage by giving misoprostol plus syntocinon and methergine"},{"intervention_type":"Drug","name":"Drug: Syntocinon plus methergine drugs","description":"medical prophylaxis against postpartum atony and postpartum hemorage by giving syntocinon and methergine"}],"outcomes":[{"outcome_type":"primary","measure":"The number of participants who passed cesarean section without postpartum hemorage","time_frame":"within 2 days post CS"}]}
{"nct_id":"NCT03352531","start_date":"2017-12-22","phase":"Phase 1","enrollment":108,"brief_title":"Study of the Safety, Pharmacokinetics, and Antitumor Activity of AK105 in Subjects With Advanced Solid Tumors","official_title":"A Phase 1A/1B Multicenter, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK105 in Subjects With Advanced Solid Tumors","primary_completion_date":"2019-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2020-06-30","last_update":"2019-03-07","description":"This study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of AK105 as a single agent in adult subjects with advanced solid tumor malignancies. The study consists of a dose escalation phase (Phase 1a) to determine the maximum tolerated dose (MTD), or recommended Phase 2 dose (RP2D) for AK105 as a single agent, and a dose expansion phase (Phase 1b) in subjects with specific tumor types which will characterize treatment of AK105 as a single agent at the MTD or RP2D.","other_id":"AK105-101","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Written and signed informed consent and any locally required authorization obtained\r\n             from the subject/legal representative.\r\n\r\n          -  In dose-escalation cohorts (Phase 1a), histologically or cytologically documented\r\n             advanced or metastatic solid tumor that is refractory/relapsed to standard therapies,\r\n             or for which no effective standard therapy is available, or the subject refuses\r\n             standard therapy.\r\n\r\n          -  In the dose-expansion cohorts (Phase 1b), histologically or cytologically confirmed\r\n             selected advanced solid tumors.\r\n\r\n          -  Subject must have at least one measurable lesion according to RECIST Version1.1.\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.\r\n\r\n          -  Available archived tumor tissue sample to allow for correlative biomarker studies. In\r\n             the setting where archival material is unavailable or unsuitable for use, the subject\r\n             must consent and undergo fresh tumor biopsy.\r\n\r\n          -  Adequate organ function.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of severe hypersensitivity reactions to other mAbs.\r\n\r\n          -  For dose-escalation phase (Phase 1a), prior exposure to any anti-PD-1, anti-PD-L1,\r\n             anti-CTL4 antibody. For dose-expansion phase (Phase 1b), prior exposure to any\r\n             anti-PD-1, anti-PD-L1, anti-CTL4 antibody or any other antibody or drug targeting\r\n             T-cell costimulation or checkpoint pathways such as ICOS, or agonists such as CD40,\r\n             CD137, GITR, OX40 etc.\r\n\r\n          -  Receipt of any immunotherapy, any conventional or investigational systemic anticancer\r\n             therapy within 4 weeks prior to the first dose of AK105.\r\n\r\n          -  Prior treatment with systemic immune modulating agents (other than agents specified\r\n             above) that was within 28 days prior to enrollment, or within 90 days prior to\r\n             enrollment if there was an immune related adverse event, or associated with toxicity\r\n             that resulted in discontinuation of the immune modulating agent.\r\n\r\n          -  Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer\r\n             treatment. Concurrent use of hormones for non-cancer related conditions is acceptable.\r\n\r\n          -  Subjects with a condition requiring systemic treatment with either corticosteroid (>\r\n             10 mg daily prednisone equivalents) or other immunosuppressive medications within 14\r\n             days of study drug administration.\r\n\r\n          -  Active or prior documented autoimmune disease within the past 2 years.\r\n\r\n          -  Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative\r\n             colitis).\r\n\r\n          -  History of primary immunodeficiency.\r\n\r\n          -  History of organ transplant or hematopoietic stem cell that requires use of\r\n             immunosuppressives.\r\n\r\n          -  Known allergy or reaction to any component of the AK105 formulation.\r\n\r\n          -  History of interstitial lung disease or non-infectious pneumonitis except for those\r\n             induced by radiation therapies.\r\n\r\n          -  Any condition that, in the opinion of the investigator, would interfere with\r\n             evaluation of the investigational product or interpretation of subject safety or study\r\n             results.\r\n\r\n          -  Known history of tuberculosis.\r\n\r\n          -  Known history of testing positive for human immunodeficiency virus (HIV) or known\r\n             acquired immunodeficiency syndrome (AIDS).\r\n\r\n          -  Known active hepatitis B or C infections, or any positive test at screening for\r\n             hepatitis B or C virus indicating acute or chronic infection except for subjects with\r\n             HCC. Subjects with past or resolved HBV infection are eligible. Subjects positive for\r\n             HCV antibody are eligible only if qualitative HCV RNA tests is negative.\r\n\r\n          -  An active infection requiring systemic therapy with the exception of antiviral therapy\r\n             for hepatitis as specified by the protocol.\r\n\r\n          -  Receipt of live or attenuated vaccination within 30 days prior to the first dose of\r\n             AK105.\r\n\r\n          -  Active or prior documented esophageal or gastric variceal bleeding\r\n\r\n          -  Clinically apparent ascites on physical examination. Ascites that requires active\r\n             ongoing paracentesis (within 6 weeks prior to the first scheduled dose) to control\r\n             symptoms. Note: ascites detectable on imaging studies only are allowed.\r\n\r\n          -  Portal vein invasion at the main portal (Vp4), inferior vena cava, or cardiac\r\n             involvement of HCC based on imaging.\r\n\r\n          -  Clinically diagnosed hepatic encephalopathy characterized by asterixis.\r\n      ","sponsor":"Akesobio Australia Pty Ltd","sponsor_type":"Industry","conditions":"Advanced Cancer","interventions":[{"intervention_type":"Biological","name":"Biological: AK-105","description":"Anti-PD-1 monoclonal antibody; Subjects will receive AK105 by intravenous administration."}],"outcomes":[{"outcome_type":"secondary","measure":"Minimum observed concentration (Cmin) of AK105 at steady state","time_frame":"From first dose of AK105 through 30 days after last dose of AK105","description":"The endpoints for assessment of PK of AK105 include serum concentrations of"},{"outcome_type":"primary","measure":"Number of participants with adverse events (AEs)","time_frame":"From the time of informed consent signed through 90 days after the last dose of AK105","description":"An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment."},{"outcome_type":"primary","measure":"Number of participants with a Dose Limiting Toxicity (DLT)","time_frame":"During the first 4 weeks","description":"DLTs will be assessed during the first 4 weeks of treatment for dose-escalation phase and are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle (4 weeks) of treatment."},{"outcome_type":"secondary","measure":"Objective response rate (ORR)","time_frame":"Up to 2 years","description":"The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1."},{"outcome_type":"secondary","measure":"Disease control rate (DCR)","time_frame":"Up to 2 years","description":"The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1."},{"outcome_type":"secondary","measure":"Progression-free survival (PFS)","time_frame":"Up to 2 years","description":"Progression-free survival is defined as the time from the start of treatment with AK105 until the first documentation of disease progression or death due to any cause, whichever occurs first."},{"outcome_type":"secondary","measure":"Overall survival (OS)","time_frame":"Up to 2 years","description":"Overall survival is defined as the time from the start of treatment with AK105 until death due to any cause."},{"outcome_type":"secondary","measure":"Area under the curve (AUC) of AK105","time_frame":"From first dose of AK105 through 30 days after last dose of AK105","description":"The endpoints for assessment of PK of AK105 include serum concentrations of AK105 at different timepoints after AK105 administration."},{"outcome_type":"secondary","measure":"Maximum observed concentration (Cmax) of AK105","time_frame":"From first dose of AK105 through 30 days after last dose of AK105","description":"The endpoints for assessment of PK of AK105 include serum concentrations of AK105 at different timepoints after AK105 administration."},{"outcome_type":"secondary","measure":"Number of subjects who develop detectable anti-drug antibodies (ADAs)","time_frame":"From first dose of AK105 through to 90 days after last dose of AK105","description":"The immunogenicity of AK105 will be assessed by summarizing the number of subjects who develop detectable antidrug antibodies (ADAs)."}]}
{"nct_id":"NCT04003350","start_date":"2017-12-21","phase":"N/A","enrollment":216,"brief_title":"The Effect of Prolonged Multimodal Analgesic Regimen on Post Hospital Discharge Opioid Use and Pain Control After Primary Total Knee Arthroplasty","official_title":"The Effect of Prolonged Multimodal Analgesic Regimen on Post Hospital Discharge Opioid Use and Pain Control After Primary Total Knee Arthroplasty","primary_completion_date":"2018-11-26","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-03-15","last_update":"2019-07-01","description":"It is well recognized that a multimodal analgesia program targeting multiple pain pathways, is more effective for controlling pain during the hospital stay and in the acute postoperative period than monotherapy-based regimens, such as opioids only. This multimodal analgesic regimen also leads to reduce opioid consumption and its related side effects after hip and knee joint replacement procedures. One potential strategy to reduce the use of opioids after TKA is to administer a prolonged oral multimodal pain regimen that targets multiple pain pathways in the post hospital discharge period. This can be equal or more effective than the regimen of opioid prescriptions used after TKA. To the best of our knowledge, there have been no studies conducted that directly examine the effect of prolonged multimodal pain regimen after hospital discharge in primary TKA patients. PURPOSE: 1. To determine whether a prolonged multimodal pain regimen after discharge from primary TKA can provide equivalent or better pain control while reducing opioid consumption and, subsequently, opioid-related side effects. 2. To determine whether patient expectations and routine opioid prescription practices at the time of discharge from primary TKA impacts opioid consumption.","other_id":"2019MAUSTKA","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients undergoing unilateral primary TKA with underlying diagnosis of\r\n             osteoarthritis.\r\n\r\n          -  ASA I - III\r\n\r\n          -  Spinal anesthesia\r\n\r\n          -  All patients will have cemented total knee utilizing a medial parapatellar approach\r\n             including patellar resurfacing. A tourniquet will be used in all cases\r\n\r\n          -  Male and Female over 18 who are willing and able to provide informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Opioid use within 3 months preoperatively\r\n\r\n          -  Inability to take the protocol medications\r\n\r\n          -  Anticoagulant other than aspirin\r\n\r\n          -  Contraindication to regional anesthesia\r\n\r\n          -  Non-english speaking\r\n\r\n          -  ASA IV or greater\r\n\r\n          -  Psychiatric or cognitive disorders\r\n\r\n          -  Allergy/contraindications to protocol medications.\r\n\r\n          -  Renal insufficiency with Cr > 2.0 or hepatic failure\r\n\r\n          -  General anesthesia\r\n\r\n          -  Sensory/motor disorder involving the operative limb\r\n      ","sponsor":"Rothman Institute Orthopaedics","sponsor_type":"Other","conditions":"Osteo Arthritis Knee","interventions":[{"intervention_type":"Drug","name":"Drug: Oxycodone","description":"Patients are given, for up to 4 weeks, Oxycodone 5m PRN every four hours (up to 30 tablets)"},{"intervention_type":"Drug","name":"Drug: Tramadol","description":"Patients are given, for up to 4 weeks, Tramadol 50mg PRN every 6 hours (up to 30 tablets)"},{"intervention_type":"Drug","name":"Drug: Tylenol","description":"Tylenol 1000 mg: take as needed every 8 hours"},{"intervention_type":"Drug","name":"Drug: Meloxicam","description":"Meloxicam 15 mg as need once per day"},{"intervention_type":"Drug","name":"Drug: Gabapentin","description":"Gabapentin 200 mg with morning and evening Tylenol dose"},{"intervention_type":"Drug","name":"Drug: Metaxalone","description":"Metaxalone 800mg TID"},{"intervention_type":"Drug","name":"Drug: Esomeprazole 20mg","description":"Esomeprazole 20mg daily"}],"outcomes":[{"outcome_type":"primary","measure":"Post-operative pain","time_frame":"Postsurgery days 1-30","description":"Measured via Visual Analog scale (0-100mm)"},{"outcome_type":"primary","measure":"Opioid related side effects","time_frame":"post-surgery days 1-30","description":"Severity measured via Visual Analog scale (0-100mm)"},{"outcome_type":"secondary","measure":"opioid consumption","time_frame":"post-surgery weeks 1-4","description":"morphine milligram equivalent"},{"outcome_type":"secondary","measure":"opioid consumption","time_frame":"post-surgery weeks 1-4","description":"number of pills consumed"},{"outcome_type":"secondary","measure":"number of opioid refills","time_frame":"post-surgery weeks 1-4","description":"number of times subjects asked to have an opioid prescription refilled during post-operative period"},{"outcome_type":"secondary","measure":"90 day complications","time_frame":"post-surgery 90 days","description":"collection of all post-operative medical complications within the first 90 days after surgery"}]}
{"nct_id":"NCT03144466","start_date":"2017-12-21","phase":"Phase 1","enrollment":1,"brief_title":"A Study of Pembrolizumab And Platinum With Radiotherapy in Cervix Cancer","official_title":"Phase I Study of the Anti-PD1 Immune Checkpoint Inhibitor Pembrolizumab And Platinum in Combination With Radical radiotherApY in Cervix cAncer.","primary_completion_date":"2019-01-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2019-01-31","last_update":"2019-06-12","description":"Locally advanced cervix cancers (stage 1B-IV) are usually treated with radiotherapy, concomitant cisplatin chemotherapy and brachytherapy. Failure to achieve locoregional control (LRC) remains a problem, especially in the setting of stage III/IV disease. More importantly, however, the dominant unresolved problem remains the occurrence of distant metastatic relapse. With the knowledge that 99% of all cervix cancer is associated with human papillomavirus (HPV) infection, there is a strong rationale to consider immunomodulatory strategies in the radical management of this disease. Therefore, in this research protocol the investigator will treat patients with stage 1B-IVA carcinoma of the cervix planned to receive radical radiotherapy with concomitant cisplatin and brachytherapy. The research involves adding a new therapy in the form of an antiPD1 monoclonal antibody (pembrolizumab) to the standard treatment of radiotherapy combined with cisplatin chemotherapy and brachytherapy. This treatment seeks to activate the patient's own immune system to attack the cancer cells - and the investigator believes that adding this treatment during standard treatment may be particularly effective. Patients will receive an initial dose of pembrolizumab 2 weeks before starting a course of chemoradiotherapy and brachytherapy. In the first instance, patients will receive 100 mg of pembrolizumab and, if this is safe and tolerable in the first 3 patients, the dose will be increased to 200 mg for all other patients. Radiation will be delivered on 28 occasions with chemotherapy given intravenously in weeks 0, 1, 2 and 3. Brachytherapy will be given on 3 occasions after completion of the radiation. Additional doses of pembrolizumab will be given every 3 weeks for a further 7 doses. The investigator will assess the feasibility and safety of the combination of pembrolizumab with radiotherapy and cisplatin.","other_id":"CCR 4268","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Histologically confirmed FIGO stage 1B - IVA carcinoma of the cervix planned to\r\n             receive radical radiotherapy with concomitant cisplatin and brachytherapy. Pelvic\r\n             lymph node but not para-aortic lymph node involvement is permitted.\r\n\r\n          2. ECOG PS 0-1\r\n\r\n          3. Be willing and able to provide written informed consent for the trial.\r\n\r\n          4. Be >= 18 years of age on day of signing informed consent.\r\n\r\n          5. Have measurable disease based on RECIST 1.1.\r\n\r\n          6. Demonstrate adequate organ function (as defined in Table 1 of the trial protocol) all\r\n             screening tests should be performed within 10 days prior to confirmation of study\r\n             eligibility.\r\n\r\n          7. Female patient of childbearing potential should have a negative urine or serum\r\n             pregnancy within 72 hours prior to confirmation of study eligibility. If the urine\r\n             test is positive or cannot be confirmed as negative, a serum pregnancy test will be\r\n             required.\r\n\r\n          8. Female patients of childbearing potential should be willing to use 2 methods of birth\r\n             control or be surgically sterile, or abstain from heterosexual activity for the course\r\n             of the study through 120 days after the last dose of study medication. Patients of\r\n             childbearing potential are those who have not been surgically sterilized or have not\r\n             been free from menses for > 1 year.\r\n\r\n          9. For Concomitant cisplatin GFR>50ml/min, no contraindications to cisplatin\r\n             (pre-existing tinnitus or neuropathy)\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Requires para-aortic radiotherapy\r\n\r\n          2. Has had previous pelvic radiotherapy\r\n\r\n          3. Has had bowel resection, history of inflammatory bowel disease or autoimmune condition\r\n\r\n          4. Is currently participating in or has participated in a study of an investigational\r\n             agent or using an investigational device within 4 weeks of the first dose of\r\n             treatment.\r\n\r\n          5. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any\r\n             other form of immunosuppressive therapy within 7 days prior to the first dose of trial\r\n             treatment.\r\n\r\n          6. Has had a prior monoclonal antibody, chemotherapy, targeted small molecule therapy, or\r\n             radiation therapy. Note: If patient received major surgery, they must have recovered\r\n             adequately from the toxicity and/or complications from the intervention prior to\r\n             starting therapy.\r\n\r\n          7. Has a known additional malignancy that is progressing or requires active treatment.\r\n             Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the\r\n             skin, or in situ cervical cancer that has undergone potentially curative therapy.\r\n\r\n          8. Has an active autoimmune disease requiring systemic treatment within the past 3 months\r\n             or a documented history of clinically severe autoimmune disease, or a syndrome that\r\n             requires systemic steroids or immunosuppressive agents. Patients with vitiligo or\r\n             resolved childhood asthma/atopy would be an exception to this rule. Patients that\r\n             require intermittent use of bronchodilators or local steroid injections would not be\r\n             excluded from the study. Patients with hypothyroidism stable on hormone replacement or\r\n             Sjorgen's syndrome will not be excluded from the study.\r\n\r\n          9. Has a history of (non-infectious) pneumonitis that required steroids or current\r\n             pneumonitis.\r\n\r\n         10. Has an active infection requiring systemic therapy.\r\n\r\n         11. Has a history or current evidence of any condition, therapy, or laboratory abnormality\r\n             that might confound the results of the trial, interfere with the patient's\r\n             participation for the full duration of the trial, or is not in the best interest of\r\n             the patient to participate, in the opinion of the treating investigator.\r\n\r\n         12. Has known psychiatric or substance abuse disorders that would interfere with\r\n             cooperation with the requirements of the trial.\r\n\r\n         13. Is pregnant or breastfeeding, or expecting to conceive children within the projected\r\n             duration of the trial, starting with the pre-screening or screening visit through 120\r\n             days after the last dose of trial treatment.\r\n\r\n         14. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137.\r\n\r\n         15. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).\r\n\r\n         16. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA\r\n             [qualitative] is detected).\r\n\r\n         17. Has received a live vaccine within 30 days prior to the first dose of trial treatment.\r\n      ","sponsor":"Royal Marsden NHS Foundation Trust","sponsor_type":"Other","conditions":"Cervix Cancer","interventions":[{"intervention_type":"Combination Product","name":"Combination Product: Pembrolizumab","description":"antiPD1 monoclonal antibody"}],"outcomes":[{"outcome_type":"primary","measure":"Maximum Tolerated Dose (MTD)","time_frame":"2 years from patients commencement","description":"To establish the maximum tolerated dose (MTD) of pembrolizumab that can be safely combined with radiotherapy, brachytherapy and cisplatin in the absence of dose limiting toxicities (DLTs)"},{"outcome_type":"primary","measure":"Efficacy","time_frame":"2 years from patients commencement","description":"Establish its efficacy on progression-free survival."},{"outcome_type":"secondary","measure":"Evaluate Toxicities of Treatment","time_frame":"Through study completion, up to 19 weeks after last dose of Pembrolizumab","description":"To evaluate acute toxicity as measured during treatment by CTCAE v4.0"},{"outcome_type":"secondary","measure":"Response Rates","time_frame":"12 weeks (week 18), 6 months, 1 year and 2 following radiation treatment","description":"To determine response rates by RECIST v1.1"},{"outcome_type":"secondary","measure":"Presence / Absence of HPV","time_frame":"12 weeks following radiation therapy (Week 18)","description":"To assess cervical HPV status using a cervical smear test for the presence / absence of HPV DNA/RNA."},{"outcome_type":"secondary","measure":"Overall survival (OS)","time_frame":"Up to 2 years post treatment.","description":"To assess OS"},{"outcome_type":"secondary","measure":"Late Radiotherapy Toxicity","time_frame":"12 weeks (study week 18), 6 months, 1 year and 2 years following radiation therapy","description":"To evaluate late radiotherapy toxicity as assessed by LENTSOM"},{"outcome_type":"secondary","measure":"Progression Free survival (PFS)","time_frame":"Up to 2 years post treatment.","description":"To assess PFS"}]}
{"nct_id":"NCT03276832","start_date":"2017-12-20","phase":"Early Phase 1","enrollment":10,"brief_title":"Imiquimod and Pembrolizumab in Treating Patients With Stage IIIB-IV Melanoma","official_title":"Pilot Study to Test the Safety and Efficacy of the Combination of Imiquimod and Pembrolizumab for the Treatment of Metastatic Melanoma","primary_completion_date":"2022-02-15","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-02-15","last_update":"2021-02-25","description":"This pilot trial studies the side effects and how well imiquimod and pembrolizumab work in treating patients with stage IIIB-IV melanoma. Imiquimod may stimulate the immune system. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving imiquimod and pembrolizumab may work better at treating melanoma.","other_id":"MC1578","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histological confirmation of stage IIIB, IIIC, IVM1a, IVM1b, or IVM1c that is not\r\n             suitable for surgical resection\r\n\r\n          -  Patients must not have received prior pembrolizumab or other anti-PD1/PDL1 therapies\r\n             for their metastatic disease\r\n\r\n          -  At least one cutaneous lesion that is amenable to treatment with topical imiquimod\r\n\r\n          -  Measurable disease by RECIST\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1\r\n\r\n          -  Absolute neutrophil count (ANC) >= 1500/mm^3\r\n\r\n          -  Platelet count >= 100,000/mm^3\r\n\r\n          -  Hemoglobin > 9.0 g/dL or >= 5.6 mmol/L without transfusion or (EPO) erythropoietin\r\n             dependency (within 7 days of assessment)\r\n\r\n          -  Serum total bilirubin =< 1.5 X upper limit of normal (ULN) or direct bilirubin =<\r\n             (ULN) for subjects with total bilirubin levels > 1.5 ULN\r\n\r\n          -  Aspartate transaminase (AST) =< 2.5 x ULN or =< 5 x ULN for subjects with liver\r\n             metastases\r\n\r\n          -  Albumin >= 2.5mg/dL\r\n\r\n          -  International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless\r\n             subject is receiving anticoagulant therapy as long as PT or partial thromboplastin\r\n             time (PTT) is within therapeutic range of intended use of anticoagulants\r\n\r\n          -  Activated partial thromboplastin time (aPTT) =< 1.5 ULN unless subject is receiving\r\n             anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use\r\n             of anticoagulants\r\n\r\n          -  Creatinine =< 1.5 X upper limit of normal (ULN)\r\n\r\n               -  NOTE: measured or calculated (per institutional standard) creatinine clearance is\r\n                  acceptable >= 60 mL/min for subject with creatinine levels > 1.5 X institutional\r\n                  ULN\r\n\r\n          -  Negative urine or serum pregnancy test done =< 72 hours prior to first treatment, for\r\n             women of childbearing potential only\r\n\r\n               -  If the urine test is positive or cannot be confirmed as negative, a serum\r\n                  pregnancy test will be required\r\n\r\n          -  Provide informed written consent\r\n\r\n          -  Willing to return to enrolling institution for follow-up\r\n\r\n          -  Willing to provide tissue from a newly obtained core or excisional biopsy of a tumor\r\n             lesion in appropriate low risk cutaneous lesions\r\n\r\n               -  NOTE: if the tissue biopsy is deemed to be of increased risk for the patient, the\r\n                  biopsy should not be performed and is optional\r\n\r\n               -  NOTE: newly-obtained is defined as a specimen obtained up to 42 days prior to\r\n                  registration where no anti-cancer therapy after the specimen was obtained and\r\n                  registration\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any of the following:\r\n\r\n               -  Pregnant women\r\n\r\n               -  Nursing women\r\n\r\n               -  Men or women of childbearing potential who are unwilling to employ adequate\r\n                  contraception\r\n\r\n                    -  NOTE: female subjects of childbearing potential should be willing to use 2\r\n                       methods of birth control or be surgically sterile, or abstain from\r\n                       heterosexual activity for the course of the study through 120 days after the\r\n                       last dose of study medication; subjects of childbearing potential are those\r\n                       who have not been surgically sterilized or have not been free from menses\r\n                       for > 1 year; male subjects should agree to use an adequate method of\r\n                       contraception starting with the first dose of study therapy through 120 days\r\n                       after the last dose of study therapy; abstain from heterosexual activity is\r\n                       also acceptable method of contraception for males\r\n\r\n          -  Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment\r\n             of the investigator, would make the patient inappropriate for entry into this study or\r\n             interfere significantly with the proper assessment of safety and toxicity of the\r\n             prescribed regimens\r\n\r\n          -  Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)\r\n\r\n          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active\r\n             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac\r\n             arrhythmia, or psychiatric illness/social situations that would limit compliance with\r\n             study requirements\r\n\r\n          -  Receiving any other investigational agent which would be considered as a treatment for\r\n             the primary neoplasm or used an investigational device =< 4 weeks from registration\r\n\r\n          -  History of myocardial infarction =< 6 months, or congestive heart failure requiring\r\n             use of ongoing maintenance therapy for life-threatening ventricular arrhythmias\r\n\r\n          -  Known history of active TB (Bacillus tuberculosis)\r\n\r\n          -  Hypersensitivity to pembrolizumab or any of its excipients\r\n\r\n          -  Prior anti-cancer monoclonal antibody (mAb) =< 4 weeks prior to registration or who\r\n             has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to agents\r\n             administered more than 4 weeks prior to registration\r\n\r\n          -  Prior chemotherapy, targeted small molecule therapy, or radiation therapy =< 2 weeks\r\n             prior to registration or who has not recovered (i.e., =< grade 1 or at baseline) from\r\n             adverse events due to a previously administered agent\r\n\r\n               -  Note: subjects with =< grade 2 neuropathy are an exception to this criterion and\r\n                  may qualify for the study\r\n\r\n               -  Note: if subject received major surgery, they must have recovered adequately from\r\n                  the toxicity and/or complications from the intervention prior to starting therapy\r\n\r\n          -  Known secondary malignancy that has progressed within the last 3 years or requires\r\n             active treatment; exceptions include basal cell carcinoma of the skin or squamous cell\r\n             carcinoma of the skin that has undergone potentially curative therapy or in situ\r\n             cervical cancer\r\n\r\n          -  Known central nervous system (CNS) metastases and/or carcinomatous meningitis\r\n\r\n          -  Active autoimmune disease that has required systemic treatment in the past 2 years\r\n             (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive\r\n             drugs); replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid\r\n             replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a\r\n             form of systemic treatment\r\n\r\n          -  History of (non-infectious) pneumonitis that required steroids or current pneumonitis\r\n\r\n          -  Active infection requiring systemic therapy\r\n\r\n          -  History or current evidence of any condition, therapy, or laboratory abnormality that\r\n             might confound the results of the trial, interfere with the subject?s participation\r\n             for the full duration of the trial, or is not in the best interest of the subject to\r\n             participate, in the opinion of the treating investigator\r\n\r\n          -  Known psychiatric or substance abuse disorders that would interfere with cooperation\r\n             with the requirements of the trial\r\n\r\n          -  Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent\r\n\r\n          -  Known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or\r\n             hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is\r\n             detected)\r\n\r\n          -  Received a live vaccine =< 30 days prior to registration\r\n\r\n               -  Note: seasonal influenza vaccines for injection are generally inactivated flu\r\n                  vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist)\r\n                  are live attenuated vaccines, and are not allowed\r\n      ","sponsor":"Mayo Clinic","sponsor_type":"Other","conditions":"Metastatic Melanoma|Stage IIIB Cutaneous Melanoma AJCC v7|Stage IIIC Cutaneous Melanoma AJCC v7|Stage IV Cutaneous Melanoma AJCC v6 and v7","interventions":[{"intervention_type":"Drug","name":"Drug: Imiquimod","description":"Applied cutaneously"},{"intervention_type":"Other","name":"Other: Laboratory Biomarker Analysis","description":"Correlative studies"},{"intervention_type":"Biological","name":"Biological: Pembrolizumab","description":"Given IV"}],"outcomes":[{"outcome_type":"primary","measure":"Duration of response","time_frame":"From registration to disease progression, assessed up to 2 years","description":"Will be estimated using the Kaplan-Meier method."},{"outcome_type":"primary","measure":"Incidence of adverse events graded using Common Terminology Criteria for Adverse Events version 4.0","time_frame":"Up to 2 years","description":"For each type of toxicity reported, the proportion of patients experiencing a severe level of that toxicity will be determined."},{"outcome_type":"primary","measure":"Overall survival","time_frame":"From registration to death due to any cause, assessed up to 2 years","description":"Will be estimated using the Kaplan-Meier method."},{"outcome_type":"primary","measure":"Progression free survival","time_frame":"From registration to documentation of first disease progression or death due to any cause, assessed up to 2 years","description":"Will be estimated using the Kaplan-Meier method."},{"outcome_type":"primary","measure":"Tumor response rate defined as percentage of patients whose objective disease status meets the criteria for Response Evaluation Criteria in Solid Tumors (RECIST) criteria for partial or complete response on two consecutive disease evaluations","time_frame":"Up to 2 years","description":"If there are no tumor responses documented among these 10 patients, then upper bound of a one-sided 95% confidence interval for the tumor response rate would be 25.9%."},{"outcome_type":"secondary","measure":"Biomarker changes during treatment","time_frame":"Baseline up to 12 weeks","description":"For each patient and each biomarker, a times-series plot of biomarker value will be constructed. These graphs will be visually examined for trends within and between the group of patients whose tumor responded to treatment and the group of patients whose tumor did not respond to treatment. Will include assessing total tumor RNA through RNA seq and PDL1 expression through the use of immunohistochemistry."}]}
{"nct_id":"NCT03415204","start_date":"2017-12-20","phase":"N/A","enrollment":100,"brief_title":"Acupuncture for Post Operative Pain Following Total Knee or Hip Arthroplasty","official_title":"Acupuncture for Post Operative Pain Following Total Knee or Hip Arthroplasty","primary_completion_date":"2018-12-20","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-12-20","last_update":"2021-02-04","description":"Post operative pain (POP) is a major obstacle on the road to healing, despite the increasing interest in postoperative pain management and development of pain control modalities (1). Postoperative pain is still insufficiently treated with more than 50% of patients suffering from moderate to severe pain early after surgery .Pain after orthopedic surgery is considered especially difficult to manage. Approximately half of total knee or hip arthroplasty patients present with extreme pain immediately after surgery. Total knee and hip arthroplasty often results not only in severe perioperative pain and debilitation, but chronic pain, joint stiffness, and functional disability many months or even years following the procedure. Various modalities of treating orthopedic POP exist, but the optimal management of postoperative pain remains controversial with no clear consensus of the best method.We suggest that acupuncture can be an effective treatment for post operative pain after total knee or hip arthroplasty.","other_id":"0104-17-ZIV","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  signed informed consent, above 18 years of age, about to undergo total knee or hip\r\n             arthroplasty\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Known mental disease, active cancer disease, coagulopathy, Hepatitis B,C.\r\n      ","sponsor":"Ziv Hospital","sponsor_type":"Other","conditions":"Arthroplasty Complications","interventions":[{"intervention_type":"Other","name":"Other: acupuncture","description":"acupuncture for post operative pain"}],"outcomes":[{"outcome_type":"primary","measure":"average post operative pain during time of hospitalization","time_frame":"average pain score during 5 days following operation","description":"post operative pain will measured twice daily - morning and afternoon during hospitalization time. patients will be asked to rate thier pain on a visual analog scale ranging from 0- no pain to 10 - severe pain"}]}
{"nct_id":"NCT03164772","start_date":"2017-12-20","phase":"Phase 1/Phase 2","enrollment":56,"brief_title":"Phase 1/2 Study of Combination Immunotherapy and mRNA Vaccine in Subjects With NSCLC","official_title":"A Phase 1/2 Study of Combination Immunotherapy and mRNA Vaccine in Subjects With Non-small Cell Lung Cancer (NSCLC)","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2024-12-31","last_update":"2021-02-23","description":"This is an open-label multicenter 2-arm study to evaluate the safety and preliminary efficacy of the addition of a vaccine therapy to 1 or 2 checkpoint inhibitors for NSCLC. Arm A: mRNA Vaccine [BI 1361849 (formerly CV9202)] + anti-PD-L1 [durvalumab] Arm B: mRNA Vaccine [BI 1361849] + anti-PD-L1 [durvalumab] + anti-CTLA-4 [tremelimumab] The run-in evaluation phase is followed by an expansion phase in which the cohort is expanded to 20 subjects (inclusive of subjects from the run-in).","other_id":"LUD2014-012-VAC","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria\r\n\r\n          1. Histologic confirmation of metastatic NSCLC. For subjects with known EGFR or ALK/ROS-1\r\n             mutations, prior therapy must have included an EGFR tyrosine kinase inhibitor or\r\n             ALK/ROS-1 inhibitor, respectively. Subjects may have had 1 prior line of\r\n             anti-PD-1/PD-L1 therapy. Subjects who received prior anti-PD-1/PD-L1 therapy must have\r\n             progressed during or after treatment, but not prior to Week 12 of treatment.\r\n\r\n          2. Availability of archival (diagnostic) specimens or willing to undergo a pre-treatment\r\n             biopsy.\r\n\r\n          3. Subjects with treated brain metastases must have been treated with surgery and/or\r\n             radiation therapy  21 days pre-study and must be clinically stable with no\r\n             requirement for steroids.\r\n\r\n          4. Laboratory parameters for vital functions should be in the normal range.\r\n\r\n          5. ECOG Performance Status  2.\r\n\r\n        Exclusion Criteria\r\n\r\n        Subjects may not enter the study if they fulfill any of the following criteria:\r\n\r\n          1. Treatment with an investigational agent within 4 weeks of starting treatment or prior\r\n             treatment with anti-CTLA-4 therapy.\r\n\r\n          2. Active, suspected or prior documented autoimmune disease, clinically significant\r\n             cardiovascular disease, or clinically uncontrolled hypertension.\r\n\r\n          3. History of pneumonitis or interstitial lung disease, or any unresolved immune-related\r\n             adverse events following prior therapy.\r\n\r\n          4. Major surgery within 4 weeks of starting treatment (or scheduled for surgery during\r\n             the projected course of the study) or prior cancer vaccine treatment or allogeneic\r\n             bone marrow transplantation.\r\n\r\n          5. Subjects who are immunosuppressed, including those with known immunodeficiency or have\r\n             active infection including tuberculosis or other serious illnesses.\r\n\r\n          6. Skin disease (e.g., psoriasis) that may prevent intradermal administration of the\r\n             vaccine into the target areas.\r\n      ","sponsor":"Ludwig Institute for Cancer Research","sponsor_type":"Other","conditions":"Metastatic Non-small Cell Lung Cancer|NSCLC","interventions":[{"intervention_type":"Drug","name":"Drug: Durvalumab","description":"anti-PD-L1"},{"intervention_type":"Drug","name":"Drug: Tremelimumab","description":"anti-CTLA-4"},{"intervention_type":"Biological","name":"Biological: BI 1361849","description":"mRNA Vaccine"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Adverse Events","time_frame":"up to 15 months"},{"outcome_type":"secondary","measure":"Objective Response Rate (ORR)","time_frame":"up to 24 weeks","description":"Objective Response Rate at 8 and 24 Weeks"},{"outcome_type":"secondary","measure":"Progression Free Survival (PFS)","time_frame":"24 weeks","description":"Progression Free Survival (PFS) at 8 and 24 weeks"},{"outcome_type":"secondary","measure":"Duration of Response (DoR)","time_frame":"up to 15 months"},{"outcome_type":"secondary","measure":"Overall Survival (OS)","time_frame":"up to 5 years"}]}
{"nct_id":"NCT02657447","start_date":"2017-12-19","phase":"Phase 1","enrollment":0,"brief_title":"Dosimetry Study of Betalutin for Treatment of Relapsed Non-Hodgkin Lymphoma (LYMRIT-37-02)","official_title":"A Phase 1, Open Label, Randomized Study to Assess Pharmacokinetics, Biodistribution and Radiation Dosimetry of Lutetium (177Lu) Lilotomab Satetraxetan (Betalutin) Radioimmunotherapy in Patients With Relapsed Non-Hodgkin Lymphoma","primary_completion_date":"2019-09-30","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2020-09-30","last_update":"2019-01-10","description":"This study is a phase I, open label, randomized study to assess pharmacokinetics, biodistribution and radiation dosimetry of lutetium (177Lu) lilotomab satetraxetan (Betalutin) radioimmunotherapy in patients with relapsed non-Hodgkin lymphoma. The study will also investigate the safety, toxicity and efficacy of Betalutin and pre-dosing.","other_id":"EudraCT: 2013-003908-39","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Histologically confirmed (by WHO classification) relapsed indolent non-Hodgkin B-cell\r\n             lymphoma of following subtypes: Follicular lymphoma (follicular grade I-IIIA),\r\n             Marginal zone lymphoma (exclusion of MZL if large lymphocytes > 50%), Small\r\n             lymphocytic lymphoma, Lymphoplasmacytoid and classical mantle cell lymphoma (no\r\n             blastoid MCL).\r\n\r\n          2. Requiring initiation of treatment for the NHL.\r\n\r\n          3. Relapsed after at least one line of therapy including rituximab combination\r\n             chemotherapy regimen.\r\n\r\n          4. Exhausted and/or ineligible for all standard treatment options.\r\n\r\n          5. Not a candidate for an autologous or allogeneic stem cell transplantation. Patients in\r\n             progression after successful stem cell collection before before high-dose therapy and\r\n             autologous stem cell transplantation may be considered for enrolment.\r\n\r\n          6. Age  18 years..\r\n\r\n          7. A pre-study ECOG performance status of 0-2. In selected patients an ECOG score of 3\r\n             can be acceptable if it is clearly lymphoma-associated at the discretion of the\r\n             investigator.\r\n\r\n          8. Life expectancy should be  3 months.\r\n\r\n          9. 9. < 25% tumour cells in bone marrow biopsy prior to lilotomab/Betalutin treatment\r\n             (biopsy taken from a site not previously irradiated).\r\n\r\n         10. All patients must have at least one bi-dimensionally measurable lesion (>1.5 cm in its\r\n             largest dimension by CT scan). Patients without such a target lesion can be accepted\r\n             on an individual basis if histological organ involvement can be evaluated for response\r\n             e.g. involvement of the skin or the gastrointestinal tract.\r\n\r\n         11. Women of childbearing potential must:\r\n\r\n               -  have a negative serum pregnancy test at screening and before Betalutin injection\r\n\r\n               -  understand that the study medication is expected to have teratogenic risk\r\n\r\n               -  agree to use, and be able to comply with, highly effective method of birth\r\n                  control with a Pearl-Index  1%. Contraception is required without interruption,\r\n                  4 weeks before starting study drug, throughout study drug therapy and for 12\r\n                  months after end of study drug therapy, even if she has amenorrhoea.\r\n\r\n         12. Male subjects must agree to use condoms during intercourse throughout study drug\r\n             therapy and the following 12 months.\r\n\r\n         13. Patients previously treated with native rituximab are eligible.\r\n\r\n         14. The patient is willing and able to comply with the protocol, and agrees to return to\r\n             the hospital for follow-up visits and examination.\r\n\r\n         15. The patient has been fully informed about the study and has signed the informed\r\n             consent form.\r\n\r\n         16. Negative HAMA test.\r\n\r\n         17. CD37 positive, re-biopsy or test on existing tumour material if not known\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Medical contraindications, including uncontrolled infection, severe cardiac,\r\n             pulmonary, neurologic, psychiatric or metabolic disease, steroid requiring\r\n             asthma/allergy, known HIV positive.\r\n\r\n          2. Laboratory values during screening :\r\n\r\n               -  Absolute Neutrophil Counts (ANC)  1.5 x 109 /l\r\n\r\n               -  Platelet count  150 x 109 /l\r\n\r\n               -  Total bilirubin  30 mmol/l\r\n\r\n               -  ALP and ALAT  4x normal level\r\n\r\n               -  GFR < 60 ml/min/1.73 m2 as measured by the CKD-EPI method.\r\n\r\n          3. Known or suspected CNS involvement of lymphoma\r\n\r\n          4. Previous total body irradiation, or irradiation of > 25% of the patient's bone marrow.\r\n\r\n          5. Chemotherapy, immunotherapy or another investigational drug received within the last 4\r\n             weeks prior to the patient entering screening.\r\n\r\n          6. Earlier treatment with radioimmunotherapy.\r\n\r\n          7. Exposure to another CD37 targeting drug.\r\n\r\n          8. Concurrent participation in another therapeutic treatment trial.\r\n\r\n          9. Previous hematopoietic stem cell transplantation (autologous and allogenic).\r\n\r\n         10. Pregnant or lactating women.\r\n\r\n         11. Transformed or potentially transformed NHL from indolent to aggressive\r\n\r\n         12. Receipt of live, attenuated vaccine within 30 days prior to enrolment\r\n\r\n         13. Test positive for hepatitis B (HBsAg and anti-HBc)\r\n\r\n         14. A known hypersensitivity to rituximab, HH1, Betalutin or murine proteins or any\r\n             excipient used in rituximab, HH1 or Betalutin\r\n\r\n         15. Malignant disease, other than that being treated in this study. Exceptions include:\r\n             malignancies that were treated curatively and have not recurred within 3 years prior\r\n             to study entry; completely resected basal cell and squamous cell skin cancers;\r\n             completely resected carcinoma in situ of any type.\r\n      ","sponsor":"Nordic Nanovector","sponsor_type":"Industry","conditions":"Non-Hodgkin Lymphoma","interventions":[{"intervention_type":"Drug","name":"Drug: Betalutin with lilotomab dose 1","description":"15 MBq/kg b.w. Betalutin (lutetium (177Lu) lilotomab satetraxetan) single injection, with lilotomab pre-dosing, dose 1"},{"intervention_type":"Drug","name":"Drug: Betalutin with lilotomab dose 2","description":"15 MBq/kg b.w. Betalutin (lutetium (177Lu) lilotomab satetraxetan) single injection, with lilotomab pre-dosing, dose 2"}],"outcomes":[{"outcome_type":"primary","measure":"Dosimetry","time_frame":"3 weeks","description":"Estimation of individual tumour/organ uptake and retention of radioactivity."},{"outcome_type":"secondary","measure":"The number of participants with adverse events as assessed by NCTCAE.","time_frame":"12 weeks","description":"Adverse events by treatment group."},{"outcome_type":"secondary","measure":"Efficacy (Best overall response rate)","time_frame":"3 months - 1 year","description":"Best overall response rate by treatment group as measured by Cheson Criteria."},{"outcome_type":"secondary","measure":"Lilotomab pharmacokinetics","time_frame":"3 weeks","description":"Estimation using decay correction measurements"}]}
{"nct_id":"NCT03432975","start_date":"2017-12-18","phase":"N/A","enrollment":20,"brief_title":"Evaluation of Multiple Subgingival Irrigations.","official_title":"Evaluation of Multiple Subgingival Irrigations With 10% Povidone Iodine After Scaling and Root Planing : a Randomized Clinical Trial","primary_completion_date":"2019-08-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-08-31","last_update":"2019-07-15","description":"The study will be conducted at the Department of Periodontology, Cliniques universitaires Saint Luc. Patients diagnosed with Generalized Chronic Periodontitis (GChP) based on the current classification of the American Academy of Periodontology will be included. Detailed medical, periodontal and dental history will be obtained. Those who will fulfill the inclusion/exclusion criteria will be invited to participate in the study.","other_id":"2017/06NOV/503","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","intervention_model_description":"20 patients (=40 half-mouth); 20 half-mouth per group","sampling_method":"","gender":"All","minimum_age":30,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -   30 years of age\r\n\r\n          -  At least 15 teeth (excluding third molars and teeth with advanced decay indicated for\r\n             extraction)\r\n\r\n          -  Any history of periodontal treatment in the previous 6 months\r\n\r\n          -  No removable prosthesis\r\n\r\n          -  A minimum of 6 teeth with at least one site each with periodontal probing depth (PPD)\r\n             and clinical attachment level (CAL) 5 mm\r\n\r\n          -  At least 30% of the sites with PPD and CAL 4 mm and bleeding on probing (BOP)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any sensitivity or allergy to any of the products that will be used in the study\r\n\r\n          -  Thyroid dysfunction\r\n\r\n          -  Systemic disease (ASA II or more)\r\n\r\n          -  Need for antibiotic pre-medication for routine dental therapy\r\n\r\n          -  Antibiotic therapy in the previous 3 months\r\n\r\n          -  Pregnancy and breastfeeding\r\n\r\n          -  Current smokers (more than 5 cigarettes a day)\r\n      ","sponsor":"Cliniques universitaires Saint-Luc- Universit Catholique de Louvain","sponsor_type":"Other","conditions":"Periodontitis, Adult","interventions":[{"intervention_type":"Drug","name":"Drug: Povidone-Iodine 10%","description":"The side of the mouth receiving the subgingival irrigations of povidone iodine 10% (test group)"},{"intervention_type":"Drug","name":"Drug: Saline Solution","description":"The other side of the mouth will be irrigated with a sterile saline solution (control group)"}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of subjects reaching ≤ 4 mm in periodontal sites with PPD ≥ 5 mm","time_frame":"up to 6 months","description":"The primary objective of this study is to determine the effect of PVI on periodontal probing depth (PPD)."}]}
{"nct_id":"NCT03566849","start_date":"2017-12-15","phase":"N/A","enrollment":40,"brief_title":"Effects of the Kinetic Chain Approach for Scapular Dyskinesis","official_title":"Effects of the Kinetic Chain Management Approach on Pain and Performance in Volleyball Athletes With Scapular Dyskinesia: A Randomized Controlled Trial","primary_completion_date":"2018-11-25","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-12-10","last_update":"2019-01-07","description":"Volleyball is a highly technical sport which involved powerful overhead movements performed repetitively. Shoulder injuries is the third-most commonly injured body part in volleyball, with the majority resulting from chronic overuse. Abnormal scapular motions and positions relative to the thorax have been linked to various shoulder pathologies, including subacromial impingement, rotator cuff tears, and glenohumeral inferior instability. Also, Muscular imbalances around the shoulder complex could lead to dyskinesis and resulting in shoulder joint injuries (e.g. instability and impingement). The concept of \"kinetic chain\" is coordinated sequencing of the segments. Sequential activation of the LE, pelvis and trunk muscles is required to facilitate the forces to be transferred appropriately from these body segments to the UE. Reeser et al. have identified risk factors for volleyball-related shoulder pain and dysfunction. They found volleyball athletes who demonstrated core instability would show greater relevance to SICK scapula, and they also more likely to report a history of shoulder problems. Sciascia et al. also have reviewed that 49% athletes with posterior-superior labral tears showed either decreased hip rotators exibility or decreased hip abductors strength. Consequently, the deficits in kinetic chain segments would resulted in scapula dyskinesis, even lead to shoulder girdle dysfunction or injury. Therefore, the modern training programs for athletes, especially in overhead players, should combine kinetic chain exercises to improve upper- and lower body core strength, sport-specic strength, performance, and prevent injury occurrence or recurrence. In consideration of no randomized controlled trials (RCTs) have been performed to determine whether kinetic chain exercise would be more effective to conventional scapula training for patients with secondary shoulder impingement. The purpose of the study is to investigate the effects of kinetic chain management approach (KC) and conventional training of scapula dyskinesis (CT) in volleyball athletes with scapular dyskinesia. The investigators hypothesized that KC group would be more effective in self-reported pain, and their scapula would become more stable during movement task (arm-lifting and spiking) after a 4-week training program than CT group.","other_id":"YM106028F","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"A randomized controlled trial (RCT) with two treatment groups, kinetic chain management approach (KC) and conventional training of scapula dyskinesis (CT).","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":30,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Volleyball athletes who performed related sport activities for more than 10 hour/wks\r\n\r\n          -  Age 18-30 years, with diagnosed of scapula dyskinesia by a physical therapist\r\n\r\n          -  Shoulder girdle passive range of motion (PROM) within normal limitation\r\n\r\n          -  Visual analog score (VAS) rating of pain during activities of sport or daily living\r\n             during the previous week at a minimum of 3 cm on a 10-cm scale\r\n\r\n          -  Insidious onset of symptoms unrelated to trauma and persistent for at least 4 wks\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Can't finish the data collection process due to any other current musculoskeletal\r\n             pain/injuries\r\n\r\n          -  Any neuromuscular disorder, joint or bone disease\r\n\r\n          -  History of any orthopedic surgeries\r\n      ","sponsor":"National Yang Ming University","sponsor_type":"Other","conditions":"Shoulder Impingement Syndrome","interventions":[{"intervention_type":"Other","name":"Other: KC group","description":"1st week: each 10 rep/set, 3 set/day. PNF scapular pattern: posterior depression (Combination of isotonic, COI), Ball modified prone Cobra, Ball prone V-raise, Ball prone row, Ball side plank, Ball one-leg bridging\r\n2nd week: each 10 rep/set, 3 set/day. Half sit-up with rotation to left/right, Side plank with ER, Prone extension with rotation to left/right, Bilateral one-leg squat with flexion, Squat to row\r\n3rd week: 5 rep/set, 3 set/day (sling exercise). Prone shoulder protraction, Supine shoulder retraction, Side-lying hip ABD/ADD, Supine pelvic lift, Prone bridging\r\n4th week: each 10 rep/set, 3 set/day. Lateral lunges with shoulder ABD/ER, Lunge with trunk rotation, Forward punch plus with serape effect, Spiking exercise, One-quarter vertical squat jump"},{"intervention_type":"Other","name":"Other: CT group","description":"1st week: each 10 rep/set, 3 set/day. PNF scapular pattern: posterior depression (Combination of isotonic, COI), Knee push up plus, Modified prone Cobra, Prone V-raise, Prone row, Side-lying ER\r\n2nd week: each 10 rep/set, 3 set/day. Supine punch, Prone horizontal ABD, Prone V-raise, Prone row, Side-lying ER\r\n3rd week: each 10 rep/set, 3 set/day. Sitting chest press, Sitting ABD in scaption, Sitting overhead press, Long-sitting resisted extension, Sitting ER\r\n4th week: each 10 rep/set, 3 set/day. Standing horizontal pull-apart, Standing retraction plus ER, Standing resisted extension, Ball pushed on wall and controlled rolling, Wall push-up"}],"outcomes":[{"outcome_type":"secondary","measure":"Scapula motor control (muscle activation percentage)","time_frame":"Baseline and 4-week intervention","description":"Scapular muscles' activation during spiking task"},{"outcome_type":"primary","measure":"Scapular movement consistency (Proprioceptive Feedback Magnitude, PFM)","time_frame":"Baseline and 4-week intervention","description":"Scapular positioning (kinematics) during spiking task (spike for 30 repetition, and compare the average of first and last 3 trials)"},{"outcome_type":"secondary","measure":"Scapulo-humeral rhythm (scapular kinematics)","time_frame":"Baseline and 4-week intervention","description":"Scapular kinematics during spiking task"},{"outcome_type":"secondary","measure":"Self-reported pain (Visual Analogue Scale, VAS)","time_frame":"Baseline, end of week 1 treatment, end of week 2 treatment, end of week 3 treatment, and end of week 4 treatment","description":"The self-reported worst pain in spiking during previous one week (on a 10-cm scale, 0 cm = no pain, 10 cm = the most severe pain)"}]}
{"nct_id":"NCT03273816","start_date":"2017-12-14","phase":"N/A","enrollment":56,"brief_title":"Evaluation of the Benefit Provided by Sessions of Sophrology on the Per Operative Management of Parkinsonian Patients Planned for a Deep Brain Stimulation Surgery.","official_title":"Evaluation of the Benefit Provided by Sessions of Sophrology on the Intraoperative Management of Parkinsonian Patients in the Context of Deep Brain Stimulation Surgery.","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-12-31","last_update":"2021-04-14","description":"Deep brain stimulation surgery, which consists of intracerebral implantation of electrodes, is considered one of the most effective techniques for controlling the motor fluctuations of Parkinson's disease. The particularity of this surgery is the necessity of the awakening of the patient for the correct positioning of the electrodes, it is therefore a difficult test for the patient. Medical sophrology is an ideal strategy to optimize the comfort of the patient during the operation thanks to its anxiolytic and analgesic virtues while guaranteeing the maintenance of a good patient vigilance favoring the cooperation with the operating room team. Indeed, sophrology is a body-mediated set of techniques, at the crossroads between hypnosis and yoga, which makes it possible to find a balance between emotions, thoughts and behaviors. It has already been applied in other fields such as oncology, pain management, preparation for childbirth, and for 5 years at the CHU of Rennes for preparation for the intervention of deep brain stimulation.","other_id":"35RC16_9805","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"Single","intervention_model_description":"Randomized, controlled, bi-centric (national), superiority, open-label, blind-blind (evaluator) trial comparing sophrology to routine care in preparation for deep brain stimulation. The distribution of patients will be balanced between the two groups.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adult patient (age greater than or equal to 18 years)\r\n\r\n          -  Patient with idiopathic Parkinson's disease with programmed deep brain stimulation\r\n             (VIM target, NST, single or bilateral GPI);\r\n\r\n          -  Planned intervention in an awake patient (implying MOCA> 21 (Montreal Cognitive\r\n             Assessment));\r\n\r\n          -  Patient understanding the course of the study;\r\n\r\n          -  Patient who has given informed consent in writing;\r\n\r\n          -  Patient benefiting from a system of social insurance.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  - Intervention under general anesthesia;\r\n\r\n          -  Pregnant or nursing women;\r\n\r\n          -  Major person under protective measures (safeguard of justice, curatorship and\r\n             guardianship);\r\n\r\n          -  Person deprived of liberty.\r\n\r\n          -  Patient having already had a practice in yoga, sophrology, hypnotherapy superior or\r\n             equal to 5 sessions\r\n      ","sponsor":"Rennes University Hospital","sponsor_type":"Other","conditions":"Parkinson Disease|Deep Brain Stimulation","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: sessions of sophrology","description":"10 sessions of sophrology in preparation for the intervention 5 weeks before this one."}],"outcomes":[{"outcome_type":"primary","measure":"Patient anxiety","time_frame":"at one hour after the beginning of the intervention","description":"patient anxiety evaluated by the STAI-YA (State Trait Anxiety Inventory), retranscribed by a caregiver of the block, the patient being unable in practice to fill in a questionnaire at that time"},{"outcome_type":"secondary","measure":"Per operative pain","time_frame":"intraoperative (at the beginning of the intervention)","description":"Per operative pain judged by a visual scale analogous"},{"outcome_type":"secondary","measure":"Per operative pain","time_frame":"at one hour after the begginnig of the intervention","description":"Per operative pain judged by a visual scale analogous"},{"outcome_type":"secondary","measure":"Per operative pain","time_frame":"Intraoperative (At the end of the first electrode placement)","description":"Per operative pain judged by a visual scale analogous"},{"outcome_type":"secondary","measure":"Evaluation of the anxiety","time_frame":"At one hour before the procedure","description":"Evaluation of the anxiety measured by the STAI YA"},{"outcome_type":"secondary","measure":"Evaluation of the anxiety","time_frame":"Intraoperative (At the end of the first electrode placement)","description":"Evaluation of the anxiety measured by the STAI YA"},{"outcome_type":"secondary","measure":"Interaction between the patient and the surgical team during the procedure","time_frame":"At Day 0","description":"interaction is judged by a visual analogue scale to be completed by the neurologist and the neurosurgeon"},{"outcome_type":"secondary","measure":"The duration of the intervention in minutes","time_frame":"intraoperative","description":"The duration of the intervention in minutes"},{"outcome_type":"secondary","measure":"Heart rate","time_frame":"At one hour after the beginning of the intervention","description":"Heart rate in beat per minute"},{"outcome_type":"secondary","measure":"Blood pressure","time_frame":"At one hour after the beginning of the intervention","description":"Blood pressure in mmHg"},{"outcome_type":"secondary","measure":"Experience of the surgical intervention","time_frame":"At 24 hours after surgery","description":"experience of the surgical intervention by the patient evaluated on a visual analog scale"},{"outcome_type":"secondary","measure":"Experience of the surgical intervention","time_frame":"one week after surgery","description":"experience of the surgical intervention by the patient evaluated on a visual analog scale"},{"outcome_type":"secondary","measure":"Experience of the perioperative period by the patient","time_frame":"one week after surgery","description":"Qualitative analysis"},{"outcome_type":"secondary","measure":"Occurrence adverse event","time_frame":"Through study completion (Day 0 to Week 1)","description":"Occurrence of hematoma"},{"outcome_type":"secondary","measure":"Occurrence adverse event","time_frame":"Through study completion (Day 0 to Week 1)","description":"Occurrence of infection"},{"outcome_type":"secondary","measure":"Occurrence adverse event","time_frame":"Through study completion (Day 0 to Week 1)","description":"Occurrence of dysfunction of material"},{"outcome_type":"secondary","measure":"Inter-group comparison of the evolution of anxiety","time_frame":"between the inclusion (Month -3) and the beginning of the intervention (Hour O)","description":"Inter-group comparison of the evolution of anxiety by the STAI-YA"}]}
{"nct_id":"NCT03033043","start_date":"2017-12-14","phase":"N/A","enrollment":80,"brief_title":"Study of the RelayPro Thoracic Stent-Graft in Subjects With an Acute, Complicated Type B Aortic Dissection","official_title":"A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro Thoracic Stent-Graft in Subjects With an Acute, Complicated Type B Aortic Dissection","primary_completion_date":"2022-03-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2027-03-31","last_update":"2021-08-23","description":"This clinical trial is a prospective, multicenter, non-blinded, non-randomized study designed to assess the RelayPro thoracic endografts in the treatment of acute, complicated type B aortic dissection. The primary endpoint will measure all-cause mortality at 30 days post-procedure.","other_id":"IP-0017-16","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subject must have an acute (symptom onset to diagnosis within 2 weeks)or subacute,\r\n             complicated type B aortic dissection (entire dissection is distal to the left\r\n             subclavian artery (LSA)), confirmed by Computed Tomography Angiography (CTA) or\r\n             Magnetic Resonance Angiogram (MRA), with time from symptom onset to diagnosis  6\r\n             weeks, with at least one of the following:\r\n\r\n               -  Malperfusion of the viscera, kidneys, spinal cord, or lower extremities, measured\r\n                  by clinical or radiographic evidence;\r\n\r\n               -  Rupture;\r\n\r\n               -  Intractable pain.\r\n\r\n          -  Proximal and distal aortic neck with diameter between 19 mm and 42 mm.\r\n\r\n          -  Subject's anatomy must meet all of the following anatomical criteria:\r\n\r\n               1. Proximal attachment zone distal to the left common carotid and a distal\r\n                  attachment zone proximal to the origin of the celiac artery. (Dissection is\r\n                  permitted in the distal attachment zone but is not permitted in the proximal\r\n                  attachment zone.)\r\n\r\n               2. The length of the attachment zones will depend on the intended stent-graft\r\n                  diameter and type of graft selected.\r\n\r\n               3. The proximal attachment zone should be 15 mm for 22 - 28 mm RelayPro grafts with\r\n                  bare stent (20 mm for RelayPro grafts with non-bare stent), 20 mm for 30 - 46 mm\r\n                  RelayPro grafts with bare stent (25 mm for RelayPro grafts with non-bare stent),\r\n                  and proximal to non-dissected segment (healthy zone).\r\n\r\n               4. The distal attachment zone should be 20 mm for all RelayPro grafts.\r\n\r\n               5. Coverage of the left subclavian artery is permitted with mandatory\r\n                  revascularization if patent left internal mammary artery (LIMA) bypass or left\r\n                  upper extremity (LUE) arteriovenous graft or anomalous vertebral artery off the\r\n                  aorta. Revascularization must be performed prior to device placement, and may\r\n                  occur during implant procedure, provided it is before coverage of the LSA by the\r\n                  endograft.\r\n\r\n          -  Proximal attachment zone containing a straight segment (non-tapered,\r\n             non-reverse-tapered, defined by <10% diameter change) with lengths equal to or greater\r\n             than the required attachment length for the intended device.\r\n\r\n          -  Vascular dimensions (e.g., aortic diameters, length from left subclavian to celiac\r\n             artery) must be in the range that can be safely treated with the RelayPro Thoracic\r\n             Stent-Grafts.\r\n\r\n          -  Adequate iliac or femoral artery access for introduction of the RelayPro Delivery\r\n             System. Alternative methods to gain proper access may be utilized (e.g., iliac\r\n             conduit).\r\n\r\n          -  Subject willing to comply with the follow-up evaluation schedule.\r\n\r\n          -  Subject (or Legally Authorized Representative, LAR) agrees to sign an Informed Consent\r\n             Form prior to treatment.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Diagnosis of traumatic injury or transection of the descending thoracic aorta.\r\n\r\n          -  Significant stenosis, calcification, thrombus, or tortuosity of intended fixation\r\n             sites that would compromise fixation or seal of the device.\r\n\r\n          -  Planned coverage of left carotid or celiac arteries; or anatomic variants that would\r\n             compromise circulation to the carotid, vertebral, or innominate arteries after device\r\n             placement, which is not amenable to subclavian revascularization.\r\n\r\n          -  Prior endovascular or surgical repair in the descending thoracic aorta. The device may\r\n             not be placed within any prior endovascular or surgical graft.\r\n\r\n          -  Concomitant aneurysm/disease of the ascending aorta, aortic arch, or abdominal aorta,\r\n             requiring repair. Dissection extension into the abdominal aorta is acceptable.\r\n\r\n          -  Prior abdominal aortic aneurysm repair (endovascular or surgical) that was performed\r\n             less than 6 months prior to the planned stent implant procedure.\r\n\r\n          -  Major surgical or medical procedure within 30 days prior to the planned procedure, or\r\n             is scheduled for a major surgical or medical procedure within 30 days post\r\n             implantation. This excludes any planned procedures for the prospective stent-graft\r\n             placement.\r\n\r\n          -  Untreatable allergy or sensitivity to contrast media or device components, including\r\n             metal stents.\r\n\r\n          -  Known or suspected connective tissue disorder.\r\n\r\n          -  Blood coagulation disorder or bleeding diathesis for which the treatment cannot be\r\n             suspended for one week pre- and/or post-repair.\r\n\r\n          -  Coronary artery disease with unstable angina.\r\n\r\n          -  Severe congestive heart failure (New York Heart Association functional class IV).\r\n\r\n          -  Stroke and/or Myocardial Infarction (MI) within 3 months of the planned treatment\r\n             date.\r\n\r\n          -  Pulmonary disease requiring the routine (daily or nightly) need for oxygen therapy\r\n             outside the hospital setting.\r\n\r\n          -  Acute renal failure or chronic renal insufficiency, and not receiving dialysis.\r\n\r\n          -  Hemodynamically unstable.\r\n\r\n          -  Active systemic infection and/or mycotic aneurysms.\r\n\r\n          -  Bowel necrosis.\r\n\r\n          -  Morbid obesity or other condition that may compromise or prevent the necessary imaging\r\n             requirements.\r\n\r\n          -  ASA risk classification = V (Moribund patient not expected to live 24 hours with or\r\n             without operation).\r\n\r\n          -  Less than two-year life expectancy.\r\n\r\n          -  Current or planned participation in an investigational drug or device study that has\r\n             not completed primary endpoint evaluation.\r\n\r\n          -  Currently pregnant or planning to become pregnant during the course of the study.\r\n\r\n          -  Medical, social, or psychological issues that Investigator believes may interfere with\r\n             treatment or follow-up.\r\n      ","sponsor":"Bolton Medical","sponsor_type":"Industry","conditions":"Aortic Dissection Type B","interventions":[{"intervention_type":"Device","name":"Device: Relay Pro Stent-Graft","description":"Endovascular treatment of an aortic dissection"}],"outcomes":[{"outcome_type":"primary","measure":"All-cause mortality post-procedure","time_frame":"30 days","description":"All-cause mortality 30 days post-procedure"},{"outcome_type":"secondary","measure":"Technical Success at the time of the index procedure","time_frame":"During deployment of the device","description":"Successful delivery and deployment of the device, including withdrawal of the delivery system;"},{"outcome_type":"secondary","measure":"Treatment success through 1 month","time_frame":"1 month, 6 months, 12 months, and annually through 5 years, defined as individual endpoints and as a composite","description":"Absence of Major adverse Event (MAE)\r\nAbsence of relevant MAEs:\r\nParaplegia;\r\nParaparesis;\r\nNew ischemia due to branch vessel compromise;\r\nAbsence of unintentional rupture of the dissection septum;"},{"outcome_type":"secondary","measure":"Dissection Treatment Success","time_frame":"1, 6, and 12 month follow-up visits, and annually through 5 years.","description":"• Dissection treatment success through 1 month, 6 months, 12 months, and annually through 5 years, defined as individual endpoints and as a composite"}]}
{"nct_id":"NCT02917473","start_date":"2017-12-13","phase":"N/A","enrollment":420,"brief_title":"Comparison of Two Strategies for Counseling Skin Examination and Sun Protection in First-degree Relatives of Patients With Melanoma","official_title":"Written Advice to Improve Compliance With Early Detection of Melanoma in First-degree Relatives: a Multicenter, Cluster-randomized Intervention Trial to Evaluate the Impact of Specific Incentives and Study Psychological Determinants of Early Melanoma Detection Behavior in First-degree Relatives","primary_completion_date":"2019-04-26","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-07-10","last_update":"2019-07-17","description":"First-degree relatives of patients with melanoma have a greater risk of developing melanoma. Patients are advised orally to inform their first-degree relatives that they should protect their skin from UV radiation and ask for a skin examination from a general practitioner or dermatologist. The study will evaluate the effectiveness of a written sheet in addition to the usual oral counselling to increase acceptance of skin examination by the first-degree relatives. If effective, written counselling provided to the patient for relatives should be recommended and generalized.","other_id":"INCA14/LM-FADEMELA","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Screening","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        For Patients:\r\n\r\n          -  Personal history of Stage 0 through IIB melanoma\r\n\r\n          -  At maximum of 12 weeks after surgical treatment of Stage 0 through IIA melanoma\r\n\r\n          -  Have at least one first-degree relative\r\n\r\n          -  Speaking and reading French\r\n\r\n          -  Affiliated to the French Health Insurance system\r\n\r\n          -  Signed non-opposition form at the 1 year consultation\r\n\r\n        For 1st degree relatives:\r\n\r\n          -  To be 1st degree related to a patient with melanoma\r\n\r\n          -  Speaking and reading French\r\n\r\n          -  1st degree relatives informed by patients and agreeing to fill out the psychological\r\n             questionnaires and to the use of their personal data by the investigators.\r\n      ","sponsor":"University Hospital, Tours","sponsor_type":"Other","conditions":"Melanoma|Screening","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Medical skin screening","description":"Medical skin screening"},{"intervention_type":"Behavioral","name":"Behavioral: In-person counseling","description":"In-person counseling\r\nSun protection"},{"intervention_type":"Behavioral","name":"Behavioral: Written advice","description":"Written advice"}],"outcomes":[{"outcome_type":"primary","measure":"Consulting general practitioner or dermatologist","time_frame":"1 year","description":"The number of relatives who will have consulted a dermatologist or a general practitioner to perform whole body skin examination"},{"outcome_type":"secondary","measure":"Self-skin examination reported by the relatives","time_frame":"1 year","description":"The number of relatives who declare to have performed Self-skin examination."},{"outcome_type":"secondary","measure":"Sun protection behaviors reported by the relatives","time_frame":"1 year","description":"Sun protection behaviours reported by the relatives and assessed by a questionnaire"},{"outcome_type":"secondary","measure":"Barriers to skin examination identified from psychological questionnaires in patients and their relatives","time_frame":"1 year","description":"Psychological barriers of patients and their relatives to skin examination evaluated with several questionnaires and scales."}]}
{"nct_id":"NCT03218553","start_date":"2017-12-13","phase":"Phase 3","enrollment":1222,"brief_title":"Effects of Perioperative Administration of Dexamethasone on Postoperative Complications and Mortality After Non-cardiac Major Surgery","official_title":"Effects of Perioperative Administration of Dexamethasone on Postoperative Complications and Mortality After Non-cardiac Major Surgery : a Randomized, Multicentre, Double Blind, Study","primary_completion_date":"2019-04-16","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-04-16","last_update":"2020-06-01","description":"Postoperative complications are major healthcare problems and are associated with a reduced short-term and long-term survival after surgery. Major surgery is associated with a predictable and usually transient Systemic Inflammatory Response (SIRS), depending on the magnitude of the surgical trauma. An excessive SIRS syndrome participates to the development of postoperative organ dysfunction, infection and mortality. Corticosteroids may decrease the postsurgical SIRS in cardiac surgery: in a large multicenter randomized trial, a single intravenous administration of high-dose dexamethasone did not reduce the incidence of a composite endpoint of adverse events but was associated with a reduced incidence of postoperative pulmonary complications and infections and with a reduction in hospital stay. However, a similar study, recently published in the Lancet was negative. Evidences from one meta-analysis, including 11 studies of moderate quality (439 patients in total), suggest that intraoperative administration of corticosteroids during major abdominal surgery decreases postoperative complications, including infectious complications, without significant risk of anastomotic leakage. At present, no large randomized controlled trial has been performed in patients undergoing major non-cardiac surgery. In acute medicine, several lines of evidence have shown that low to moderate doses of corticosteroids decrease the excessive inflammatory response, without inducing immuno suppression. However, despite the widespread use of corticosteroids to reduce postoperative nausea and vomiting and to improve analgesia, concerns continue to be raised about their safety, especially regarding an increased risk of postoperative infection. We hypothesize that the perioperative administration of glucocorticoids would reduce postoperative morbidity after major non-cardiac surgery through dampening of the inflammatory response. Given the number of surgical patients for whom the question applies, the study is of significant clinical importance","other_id":"RC17_0029","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":50,"maximum_age":90,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Major surgery (> 90 minutes and realized under general anesthesia) of the abdomen, pelvis,\r\n        thorax, face/neck, vascular surgery in a patient older than 65 years Or Major surgery (> 90\r\n        minutes and realized under general anesthesia) of the abdomen, pelvis, thorax, face/neck,\r\n        vascular surgery in a patient older than 50 years and presenting one of the following\r\n        criteria\r\n\r\n          -  Presence of a defined risk factor for cardiac or respiratory disease (exercise\r\n             tolerance equivalent to 6 metabolic equivalents or less)\r\n\r\n          -  Medical history of stroke\r\n\r\n          -  Moderate to severe renal impairment (clearance of creatinine  30 mll/L)\r\n\r\n          -  Active smoking\r\n\r\n          -  Averaged observed blood losses over 500 ml\r\n\r\n          -  Emergency surgery\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnant women, Minors, Adults under guardianship or trusteeship\r\n\r\n          -  Treatment with systemic corticosteroids at a dose > 5 mg.day-1 of equivalent\r\n             prednisolone in the previous 3 months\r\n\r\n          -  Patients with chronic renal failure (clearance of creatinine < 10 ml/min)\r\n\r\n          -  Patients for which death is deemed imminent and inevitable or patients with an\r\n             underlying disease process with a life expectancy of less than 1 month\r\n\r\n          -  Patient with preoperative shock (defined by the need for vasoactive drugs before\r\n             surgery)\r\n\r\n          -  Acute Pulmonary edema in the last 7 days\r\n\r\n          -  Active bacterial or viral infection\r\n\r\n          -  Allergy to the intravenous formulation of dexamethasone\r\n\r\n          -  Uncontrolled psychotic disorder (acute or chronical)\r\n      ","sponsor":"Nantes University Hospital","sponsor_type":"Other","conditions":"Major Non-cardiac Surgery","interventions":[{"intervention_type":"Drug","name":"Drug: Dexamethasone","description":"Dexamethasone : first dose : 0,2mg.kg-1 at the end of the surgical procedure, second dose (0,2 mg.kg-1) 24 hours after the surgery"},{"intervention_type":"Drug","name":"Drug: Placebos","description":"placebo : first infusion at the end of the surgical procedure, second 24 hours after the surgery"}],"outcomes":[{"outcome_type":"primary","measure":"Composite outcome at least one item among the following:-Postoperative sepsis, severe sepsis, septic shock-Postoperative pulmonary complication: pneumonia, need for invasive and/or noninvasive ventilation for respiratory failure-All-cause mortality","time_frame":"14 days"},{"outcome_type":"secondary","measure":"All cause mortality","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Hospital free days","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Rate of patients with post operative sepsis","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Postoperative intubation rate for respiratory failure","time_frame":"28 days","description":"Postoperative respiratory failure requiring invasive ventilation"},{"outcome_type":"secondary","measure":"Rate of patients with postoperative respiratory failure requiring non-invasive ventilation","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Surgical complications","time_frame":"28 days","description":"The Clavien-Dindo classification"},{"outcome_type":"secondary","measure":"Duration of hospitalization","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Rate of unplanned hospitalization in intensive care unit","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Rate of patients developing postoperative organ failures","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Blood level of marker of inflammation (C Reactive protein)","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Delayed healing defined as non hermetic scar","time_frame":"28 days"},{"outcome_type":"secondary","measure":"ICU length of stay","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Rate of patients with Gastric ulcer","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Rate of patients with Digestive bleeding","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Rate of patients with Anastomotic leakage","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Dose of insulin","time_frame":"3 days"},{"outcome_type":"secondary","measure":"Rate of patients with Hypokaliemia (< 4 mmol/l)","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Rate of patients with Dysnatremia (<139 mmol/l or > 145 mmol/l)","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Rate of patients with Hypocalcemia (<2.2 mmol/l)","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Rate of patients with Cardiac events (Atrial fibrillation / cardiac flutter, Acute coronary syndrome or Cardiac failure)","time_frame":"28 days"}]}
{"nct_id":"NCT02847247","start_date":"2017-12-11","phase":"Phase 1","enrollment":25,"brief_title":"Systemic Inflammatory Response to CCRE","official_title":"Systemic Inflammatory Response to 20,000 EU Clinical Center Reference Endotoxin in Normal Adults","primary_completion_date":"2019-08-06","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-08-06","last_update":"2019-09-20","description":"Purpose: The purpose of this study is to classify volunteers as endotoxin-responders or non-responders following inhalation of 20,000 EU Clinical Center Reference Endotoxin (CCRE). Endotoxin is a commonly encountered bioaerosol and component of indoor and outdoor air pollution. For reasons that remain unclear, some individuals appear to be more susceptible to the inflammatory effects of inhaled endotoxin than are others, possibly owing to single nucleotide polymorphisms in the Toll-like receptor 4 (TLR4) gene that influence TLR4 signaling and function. These susceptible individuals represent a population of particular interest for further mechanistic studies of the effects of endotoxin and for therapeutic trials. Susceptibility to inhaled endotoxin will be determined by measuring change in peripheral blood neutrophil counts, a biomarker of systemic inflammation, following inhaled CCRE. In our previous work, the investigators have found that inhalation of 20,000 EU CCRE is well tolerated and induces measurable increase in neutrophil content of peripheral blood in susceptible individuals. Our hope is that this CCRE inhalation protocol can be employed to screen large populations for susceptibility to the inflammatory effect of inhaled endotoxin.","other_id":"15-1458","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Subjects must be 18-50 years of age to be eligible for study participation\r\n\r\n          2. Subjects must be willing to and able to provide informed consent and participate in\r\n             all study procedures\r\n\r\n          3. Normal lung function, defined as (Knudson 1976/1984 predicted set):\r\n\r\n               -  1. Forced Vital Capacity (FVC) of > 80% of that predicted for gender, ethnicity,\r\n                  age and height\r\n\r\n               -  2. Forced Expiratory Volume in the first second (FEV1) of > 80% of that predicted\r\n                  for gender, ethnicity, age and height\r\n\r\n               -  3. FEV1/FVC ratio of > 0.75 of that predicted for gender, ethnicity, age and\r\n                  height\r\n\r\n          4. Oxygen saturation of > 94% Normal blood pressure (Systolic between 150 - 90, Diastolic\r\n             between 90-60 mm Hg)\r\n\r\n          5. Symptom Score (defined in section \"f\") no greater than 6 (out of a possible 24) for\r\n             total symptom score with a value no greater than 2 for any one score.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Any chronic medical condition considered by the PI as a contraindication to the\r\n             exposure study including significant cardiovascular disease, diabetes requiring\r\n             medication, chronic renal disease, or chronic thyroid disease.\r\n\r\n          2. Physician directed emergency treatment for asthma exacerbation within the preceding 3\r\n             months.\r\n\r\n          3. Moderate or Severe asthma\r\n\r\n          4. Exacerbation of asthma more than 2x/week that would be characteristic of a person of\r\n             moderate or severe persistent asthma as outlined in the current NHLBI guidelines for\r\n             diagnosis and management of asthma.\r\n\r\n          5. Nighttime symptoms of cough or wheeze greater than 1x/week at baseline (not during a\r\n             clearly recognized viral induced asthma exacerbation) which would be characteristic of\r\n             a person of moderate or severe persistent asthma as outlined in the current NHLBI\r\n             guidelines for diagnosis and management of asthma\r\n\r\n          6. Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest\r\n             tightness) which would be characteristic of a person of moderate or severe persistent\r\n             asthma as outlined in the current NHLBI guidelines for diagnosis and management of\r\n             asthma. (Not to include prophylactic use of albuterol prior to exercise).\r\n\r\n          7. History of intubation for asthma\r\n\r\n          8. Daily use of NSAIDs, or inability to withhold NSAIDs for 4 days prior to dosing.\r\n\r\n          9. Use of medications that may impact the results of the study to include, but not\r\n             limited to, systemic corticosteroids, beta blockers.\r\n\r\n         10. Cigarette smoking > 1 pack per month.\r\n\r\n         11. BMI>35.\r\n\r\n         12. Pregnant or breast feeding women will not be included.\r\n\r\n         13. Subjects who are employed within the past 6 months in an occupation with high risk for\r\n             endotoxin exposure, such as grain storage sites or swine containment.\r\n\r\n         14. Subjects will be deferred after any acute, non-chronic medical condition requiring\r\n             treatment, such as bronchitis, pneumonia or febrile illness for a minimum of 4 weeks\r\n             after complete resolution of symptoms.\r\n\r\n             -\r\n      ","sponsor":"University of North Carolina, Chapel Hill","sponsor_type":"Other","conditions":"Healthy","interventions":[{"intervention_type":"Drug","name":"Drug: CCRE","description":"Endotoxin challenge: Subjects will undergo inhalation of 20,000 EU CCRE. The CCRE will be inhaled by subjects as a nebulized preparation using an ultrasonic nebulizer until the challenge solution is completely spent (generally 10 minutes)."}],"outcomes":[{"outcome_type":"primary","measure":"Change in peripheral blood PMNs","time_frame":"6 hrs post exposure","description":"The objective of this study is to identify endotoxin responders, characterized by an increase in post-CCRE peripheral blood polymorphonuclear (PMN)s compared to that day's baseline values of > 20%. Thus, there will be two data points for this cohort, blood PMNs at baseline and PMNs 6 hours following 20,000 endotoxin units (EU) of CCRE."}]}
{"nct_id":"NCT02512497","start_date":"2017-12-08","phase":"Phase 1","enrollment":10,"brief_title":"Romidepsin Maintenance After Allogeneic Stem Cell Transplantation","official_title":"Romidepsin Therapy in Conditioning and Maintenance in Patients With T-Cell Malignancies Receiving Allogeneic Stem Cell Transplant","primary_completion_date":"2020-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2020-12-31","last_update":"2020-01-07","description":"The goal of this clinical research study is to learn if giving romidepsin before and after a stem cell transplant in combination with fludarabine and busulfan can help to control leukemia or lymphoma. Researchers also want to learn the highest tolerable dose of romidepsin that can be given with this combination. The safety of this combination and the safety of giving romidepsin after a stem cell transplant will also be studied. This is an investigational study. Romidepsin is FDA approved and commercially available for the treatment of CTCL in patients who have received at least 1 systemic (affecting the whole body) therapy before. Busulfan and fludarabine are FDA approved and commercially available for use with a stem cell transplant. The use of the combination of romidepsin, busulfan, and fludarabine to treat the type of leukemia or lymphoma you have is considered investigational. Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.","other_id":"OSU-16242","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age 18 to 70 years of age.\r\n\r\n          -  Diagnosis of either Cutaneous T-Cell Lymphoma; T-Prolymphocytic Leukemia; T-Large\r\n             Granulocytic Leukemia; T-Lymphoblastic Leukemia/lymphoma; or Peripheral T-Cell\r\n             Lymphoma, Natural Killer/T-cell lymphoma for whom allogeneic stem cell transplantation\r\n             is indicated.\r\n\r\n          -  An 10/10 or 8/8 HLA matched (high resolution typing at A, B, C, DRB1, DQ1) sibling or\r\n             unrelated donor.\r\n\r\n          -  EF>/= 50% on MUGA scan or Echocardiogram.\r\n\r\n          -  FEV1, FVC and corrected DLCO >/= 40%.\r\n\r\n          -  Adequate renal function, as defined by estimated serum creatinine clearance >/=50\r\n             ml/min (using the Cockcroft-Gault formula: creatinine clearance =\r\n             [(140-age)*kg/(72*serum creatinine)] * 0.85 if female) and/or serum creatinine <\/=1.6\r\n             mg/dL. Renal function will be calculated using ideal body weight (IBW), unless a\r\n             patient weights >40% of their IBW, then adjusted body weight will be utilized.\r\n\r\n          -  Serum bilirubin <\/= 1.5 x upper limit of normal.\r\n\r\n          -  SGOT and SGPT <\/= 2 x upper limit of normal.\r\n\r\n          -  Able to sign informed consent.\r\n\r\n          -  Men and women of reproductive potential must agree to follow accepted birth control\r\n             methods for the duration of the study. Female subject is either post-menopausal or\r\n             surgically sterilized or willing to use an acceptable method of birth control (i.e., a\r\n             hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with\r\n             spermicide, or abstinence) for the duration of the study. Male subject agrees to use\r\n             an acceptable method for contraception for the duration of the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patient with active CNS disease.\r\n\r\n          -  Pregnancy (positive Beta HCG test in a woman with child bearing potential defined as\r\n             not post-menopausal for 12 months or no previous surgical sterilization) or currently\r\n             breast-feeding. Pregnancy testing is not required for post-menopausal or surgically\r\n             sterilized women.\r\n\r\n          -  Active hepatitis B, either active carrier (HBsAg +) or viremic (HBV DNA >/=10,000\r\n             copies/mL, or >/= 2,000 IU/mL).\r\n\r\n          -  Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic\r\n             hepatitis C or positive hepatitis C serology.\r\n\r\n          -  HIV infection.\r\n\r\n          -  Hematopoetic Transplant Co-Morbidity Index (HCT-CI) >4 unless deemed clinically\r\n             insignificant by primary investigator for patients receiving Time-Sequential Busulfan\r\n             (total exposure 20000 umol-min).\r\n\r\n          -  Active uncontrolled bacterial, viral or fungal infections.\r\n\r\n          -  Exposure to other investigational drugs within 4 weeks before enrollment.\r\n\r\n          -  Grade >/= 3 non-hematologic toxicity from previous therapy that has not resolved to\r\n             <\/= grade 1.\r\n\r\n          -  Radiation therapy to head and neck (excluding eyes), and internal organs of chest,\r\n             abdomen or pelvis in the month prior to enrollment.\r\n\r\n          -  Prior whole brain irradiation.\r\n\r\n          -  Prior autologous SCT in the prior 12 months.\r\n\r\n          -  Congenital QT syndrome, QTc >500 ms.\r\n\r\n          -  Myocardial infarction within 1 year of study entry. Subjects with a history of\r\n             myocardial infarction between 6 and 12 months prior to study entry who are\r\n             asymptomatic and have had a negative cardiac risk assessment (treadmill stress test,\r\n             nuclear medicine stress test, or stress echocardiogram) since the event may\r\n             participate;\r\n\r\n          -  Other significant EKG abnormalities including 2nd degree atrio-ventricular (AV) block\r\n             type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50\r\n             beats/min);\r\n\r\n          -  Symptomatic coronary artery disease (CAD), e.g., angina Canadian Class II-IV. In any\r\n             patient in whom there is doubt, the patient should have a stress imaging study and, if\r\n             abnormal, angiography to define whether or not CAD is present;\r\n\r\n          -  An EKG recorded at screening showing evidence of cardiac ischemia (ST depression\r\n             depression of >/= 2 mm, measured from isoelectric line to the ST segment). If in any\r\n             doubt, the patient should have a stress imaging study and, if abnormal, angiography to\r\n             define whether or not CAD is present;\r\n\r\n          -  Congestive heart failure (CHF) that meets New York Heart Association (NYHA) Class II\r\n             to IV definitions and/or ejection fraction <40% by MUGA scan or <50% by echocardiogram\r\n             and/or MRI;\r\n\r\n          -  A known history of sustained ventricular tachycardia (VT), ventricular fibrillation\r\n             (VF), Torsade de Pointes, or cardiac arrest unless currently addressed with an\r\n             automatic implantable cardioverter defibrillator (AICD);\r\n\r\n          -  Hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or other\r\n             causes;\r\n\r\n          -  Uncontrolled hypertension, i.e., blood pressure (BP) of >/= 160/95; patients who have\r\n             a history of hypertension controlled by medication must be on a stable dose and meet\r\n             all other inclusion criteria; or,\r\n\r\n          -  Any cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable doses\r\n             of beta-blockers).\r\n\r\n          -  Patients taking drugs leading to significant QT prolongation where the interaction is\r\n             too great to proceed with romidepsin.\r\n\r\n          -  Concomitant use of CYP3A4 inhibitors where the interaction is thought too great to\r\n             proceed with romidepsin.\r\n      ","sponsor":"Ohio State University Comprehensive Cancer Center","sponsor_type":"Other","conditions":"Cutaneous T-cell Lymphoma|T-Prolymphocytic Leukemia|T-Large Granulocytic Leukemia|T-Lymphoblastic Leukemia/Lymphoma|Peripheral T-Cell Lymphoma","interventions":[{"intervention_type":"Drug","name":"Drug: Romidepsin","description":"Part 1: Romidepsin dosed per actual body weight/actual body surface area. Romidepsin administered on Day -6, -5, -4, and -3 at escalating doses of 1 mg/m2, 2 mg/m2, and 3 mg/m2 by vein to determine the maximal tolerated dose.\r\nRomidepsin Maintenance Therapy - Part 2: Starting between Day +28 and Day +100, if participant is eligible based on disease status, they will continue to receive Romidepsin 8 mg/m2 by vein over 1 hour on Day 1 of each 2-week cycle."},{"intervention_type":"Drug","name":"Drug: Busulfan","description":"Part 1: First 2 doses of Busulfan of 80 mg/m2 administered on day -13 and -12. Busulfan administered at the dose calculated to achieve a total (including first two doses delivered on Day -13 and -12) systemic exposure of 20,000  12% Mol-min based on the pharmacokinetic (PK) studies. An additional standard of care (SOC) option is now added for those with an HCT-CI >4 or deemed unfit by the investigator to receive full dose (AUC 5000 umol-min) Time-Sequential (TS) Busulfan. SOC busulfan is administered per OSU SCT SOP with a targeted AUC of 4000 umol-min/day for a total exposure of 16,000 umol-min +/- 12% u-Mol-min based upon PK studies. Busulfan 'test-dose' PK studies will be performed prior to administration of full dose of busulfan per SOC. Romidepsin and fludarabine will be administered in an identical fashion using the SOC busulfan as with the TS busulfan. TS busulfan method of busulfan administration will be the preferred method of conditioning therapy for patients enrolled."},{"intervention_type":"Drug","name":"Drug: Fludarabine","description":"Part 1: Fludarabine 40 mg/m2 by vein on Days -6 to -3."},{"intervention_type":"Procedure","name":"Procedure: Stem Cell Transplant","description":"Stem cell infusion on Day 0."},{"intervention_type":"Drug","name":"Drug: Thymoglobulin","description":"Participants receiving a graft from a matched unrelated donor receive rabbit Thymoglobulin; 0.5 mg/kg on Day -3, 1.5 mg/kg on Day -2 and 2.0 mg/kg on Day -1."}],"outcomes":[{"outcome_type":"primary","measure":"Toxicity of Romidepsin with Busulfan and Fludarabine Conditioning Therapy for Allogeneic Stem Cell Transplantation","time_frame":"30 days","description":"Toxicity defined as death from any cause, grade 3 or 4 graft-versus-host disease, grade 3-4 mucositis lasting for more than 3 days at peak severity, or or grade 3 or 4 non-hematologic non-infectious toxicity within 30 days of receiving the first Romidepsin administration on day -6 (day 24 post allosct)."},{"outcome_type":"primary","measure":"Efficacy of Romidepsin with Busulfan and Fludarabine Conditioning Therapy for Allogeneic Stem Cell Transplantation","time_frame":"30 days post allosct","description":"Efficacy defined as the participant being engrafted and alive at day 30 post allosct."}]}
{"nct_id":"NCT03318263","start_date":"2017-12-07","phase":"N/A","enrollment":146,"brief_title":"CIrCuLAting Dna ESr1 Gene Mutations Analysis","official_title":"Monitoring of ESR1, PIK3CA and AKT ctDNA Mutations During Real-life Followup of Patients With Metastatic Breast Cancer Treated With Aromatase Inhibitors","primary_completion_date":"2022-12-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2022-12-31","last_update":"2021-08-26","description":"The estrogen-dependent nature of breast cancer was first reported in 1896 with the publication of George Beatson's observations on the regression of breast cancer following oophorectomy. Endocrine therapy, targeting ER either directly by selective estrogen receptor modulators (SERMs) and pure antagonists or indirectly by aromatase inhibitors (AIs) that block estrogen production, remains the mainstay of treatment of hormone-sensitive breast cancer in the adjuvant and metastatic settings. Intrinsic (de novo) and acquired endocrine resistance constitutes an important clinical challenge in the treatment of breast cancer and multiple mechanisms are suspected to underlie the emergence of endocrine resistance. The role of the estrogen receptor (ER), encoded by the ESR1 gene, in normal mammary gland development and the progression of breast cancer is well established. ESR1 mutations, occurring in 10 to 30% of ER-positive metastatic breast cancer resistant to AIs, lead to ligand-independent activation of the ER. For patients treated with AIs, monitoring of circulating tumour DNA (ctDNA) for ESR1, PIK3CA and AKT1 mutations could permit early detection of resistance to AIs as recently reported during 2016 American Society of Clinical Oncology (ASCO) meeting.","other_id":"2017-A01767-46","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Female patient aged 18 and older\r\n\r\n          2. Histologically confirmed estrogen-receptor-positive, HER2-negative breast cancer\r\n\r\n          3. Proven metastatic (AJCC stage IV) or loco-regionally advanced (AJCC stage III) breast\r\n             cancer, not amenable to surgery or radiation with curative intent.\r\n\r\n          4. Indication to treat with first-line endocrine therapy for palliative care.\r\n\r\n               -  Patients already receiving first-line endocrine therapy can be enrolled up to 6\r\n                  weeks after start of endocrine therapy.\r\n\r\n               -  Endocrine therapy can be prescribed in combination with a CDK4/6 inhibitor.\r\n\r\n               -  One prior regimen of chemotherapy for the treatment of advanced disease is\r\n                  allowed.\r\n\r\n               -  Prior (neo)adjuvant chemotherapy and/or (neo)adjuvant endocrine therapy is/are\r\n                  allowed; patients with recurrence while on adjuvant endocrine therapy can be\r\n                  enrolled.\r\n\r\n          5. Patients who can benefit from an additional blood sample of 10ml. The total volume of\r\n             each sample meets with the indications of the Order in force establishing the list of\r\n             researches mentioned in 2  of Article L. 1121-1 of the Public Health Code.\r\n\r\n          6. Informed consent explained to, understood by and signed by patient. Patient must be\r\n             given a copy of informed consent.\r\n\r\n          7. Patients affiliated to a social security scheme or benefit from a social regime\r\n\r\n        The prescription of medicinal product(s) is clearly separated from the decision to include\r\n        the subject in this ISMRC.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Pregnant or breast-feeding woman.\r\n\r\n          2. Patient who received any prior systemic hormonal therapy for advanced breast cancer;\r\n             no more than one prior regimen of chemotherapy for the treatment of advanced disease\r\n             is allowed.\r\n\r\n          3. Chemotherapy in combination with endocrine therapy.\r\n\r\n          4. Targeted therapy, except CDK 4/6 inhibitor, in combination with endocrine therapy.\r\n\r\n          5. Planned surgery or radiation with curative intent.\r\n\r\n          6. Other active malignancy.\r\n\r\n          7. Any concurrent severe and/or uncontrolled medical condition(s) which could compromise\r\n             participation in the study.\r\n\r\n          8. Patient whose general state and / or conditions do not permit the collection of the\r\n             additional blood sample.\r\n\r\n          9. Patients under guardianship, under curatorship or deprived of liberty.\r\n      ","sponsor":"Institut de Cancrologie de Lorraine","sponsor_type":"Other","conditions":"Breast Cancer","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: next-generation sequencing (NGS)","description":"ESR1, PI3KCA and AKT extensive exon sequencing will be performed using NGS (Miseq Illumina) at the Biopathology department, Institut de Cancrologie de Lorraine (ISO15189 certified lab). Samples taken at baseline (t0), at progression (tp) and 3 months before progression (tp-3) will be systematically analyzed. The intermediate samples will be stored and kept for additional studies. Follow up assessment will be performed according to prescriber's directions."}],"outcomes":[{"outcome_type":"primary","measure":"incidence of ESR1 mutations","time_frame":"1 day"},{"outcome_type":"secondary","measure":"incidence of PIK3CA and AKT1 mutations","time_frame":"1 day"},{"outcome_type":"secondary","measure":"prevalence of ESR1, PIK3CA and AKT1 mutations in patients with and without endocrine resistance at enrolment","time_frame":"1 day"},{"outcome_type":"secondary","measure":"prevalence of ESR1, PIK3CA and AKT1 mutations in patients according to mono vs combo therapy.","time_frame":"1 day"},{"outcome_type":"secondary","measure":"prevalence of mutations of other genes of interest included in the panel from the start of treatment to progression or end of follow-up","time_frame":"1 day"},{"outcome_type":"secondary","measure":"ESR1, PIK3CA and AKT1 mutations predictor of progression free survival","time_frame":"1 day"}]}
{"nct_id":"NCT03012230","start_date":"2017-12-06","phase":"Phase 1","enrollment":18,"brief_title":"Pembrolizumab and Ruxolitinib Phosphate in Treating Patients With Metastatic Stage IV Triple Negative Breast Cancer","official_title":"A Phase 1 Study of PD-1 Inhibition With Pembrolizumab Combined With JAK2 Inhibition in Triple Negative Breast Cancer","primary_completion_date":"2022-03-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-03-01","last_update":"2021-05-25","description":"This phase I trial studies the side effects and best dose of ruxolitinib phosphate when given together with pembrolizumab in treating patients with stage IV triple negative breast cancer that has spread to other places in the body. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ruxolitinib phosphate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and ruxolitinib phosphate together may work better in treating patients with stage IV triple negative breast cancer.","other_id":"MC1534","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Metastatic (stage IV) triple negative breast cancer that has progressed after at least\r\n             one prior chemotherapy regimen in the metastatic setting or refusal of chemotherapy in\r\n             the metastatic setting; non-measurable disease (i.e. bone metastases) is permitted\r\n\r\n          -  Histological confirmation of triple negative breast cancer defined as:\r\n\r\n               -  Her2/neu by fluorescence in situ hybridization (FISH) (ratio =< 1.8) or\r\n                  immunohistochemistry (IHC) (0 or 1+)\r\n\r\n               -  Estrogen receptor (ER) and progesterone receptor (PR) expression < 10%\r\n\r\n          -  Absolute neutrophil count (ANC) >= 1500/mm^3 (obtained =< 7 days prior to\r\n             registration)\r\n\r\n          -  Platelet count >= 100,000/mm^3 (obtained =< 7 days prior to registration)\r\n\r\n          -  Total bilirubin =< 1.5 x upper limit normal (ULN) (obtained =< 7 days prior to\r\n             registration)\r\n\r\n          -  Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and\r\n             alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x\r\n             ULN or < 5 x ULN if organ involvement (obtained =< 7 days prior to registration)\r\n\r\n          -  Alkaline phosphatase < 5 x ULN (obtained =< 7 days prior to registration)\r\n\r\n          -  Serum creatinine =< 2 x ULN or 24 hour creatinine (Cr) clearance > 60 ml/min (obtained\r\n             =< 7 days prior to registration)\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1\r\n\r\n          -  Ability to provide informed written consent and be able to adhere to the study visit\r\n             schedule and other protocol requirements\r\n\r\n          -  Willing to return to enrolling institution for follow-up (during the active monitoring\r\n             phase of the study)\r\n\r\n          -  Willing to provide blood samples for correlative research purposes\r\n\r\n          -  Has existing archived tissue and is willing to consent to providing sample for\r\n             correlative research purposes\r\n\r\n          -  Female subjects of childbearing potential should have a negative serum pregnancy =< 7\r\n             days prior to registration\r\n\r\n          -  Female subjects of childbearing potential should be willing to use 2 methods of birth\r\n             control or be surgically sterile, or abstain from heterosexual activity for the course\r\n             of the study through 120 days after the last dose of study medication; subjects of\r\n             childbearing potential are those who have not been surgically sterilized or have not\r\n             been free from menses for > 1 year; Note: abstinence is acceptable if this is the\r\n             usual lifestyle and preferred contraception for the subject\r\n\r\n          -  Male subjects of childbearing potential must agree to use an adequate method of\r\n             contraception starting with the first dose of study therapy through 120 days after the\r\n             last dose of study therapy; Note: abstinence is acceptable if this is the usual\r\n             lifestyle and preferred contraception for the subject\r\n\r\n          -  Radiographic or clinically measurable evidence of disease progression\r\n\r\n          -  Prior therapy with atezolizumab is acceptable providing that all atezolizumab-related\r\n             toxicities have resolved\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Uncontrolled intercurrent illness including, but not limited to, active uncontrolled\r\n             infection, known positive for active infectious hepatitis, type A, B or C (past\r\n             infection allowed), or psychiatric illness/social situations that would limit\r\n             compliance with study requirements; Note: ongoing infection controlled on\r\n             antibiotics/antifungal/antiviral medications are allowed\r\n\r\n          -  Any of the following prior therapies:\r\n\r\n               -  Cytotoxic chemotherapy =< 14 days prior to registration\r\n\r\n               -  Immunotherapy =< 14 days prior to registration\r\n\r\n               -  Biologic therapy (i.e. antibody therapies) =< 28 days prior to registration\r\n\r\n               -  Radiation therapy =< 14 days prior to registration\r\n\r\n               -  Targeted therapies (i.e. PARP inhibitors, =< 7 days or 5 half-lives whichever is\r\n                  shorter)\r\n\r\n               -  Receiving any other investigational agent which would be considered as a\r\n                  treatment for the primary neoplasm =< 14 days prior to registration\r\n\r\n          -  Active uncontrolled central nervous system (CNS) metastases\r\n\r\n          -  Immunocompromised patients and patients known to be human immunodeficiency virus (HIV)\r\n             positive\r\n\r\n          -  Hypersensitivity to ruxolitinib or any of its excipients\r\n\r\n          -  Major surgery =< 28 days prior to registration; Note: if subject received major\r\n             surgery, they must have recovered adequately from the toxicity and/or complications\r\n             from the intervention prior to starting therapy\r\n\r\n          -  Clinically significant heart disease, including the following:\r\n\r\n               -  Active severe angina pectoris prior to registration\r\n\r\n               -  Acute myocardial infarction prior to registration\r\n\r\n               -  New York Heart Association classification IV cardiovascular disease or\r\n                  symptomatic class III disease\r\n\r\n               -  Note: patients with any of the above may be allowed after discussion amongst the\r\n                  investigators including the principal investigator\r\n\r\n          -  Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any\r\n             other form of immunosuppressive therapy within 7 days prior to registration\r\n\r\n          -  Hypersensitivity to pembrolizumab or any of its excipients\r\n\r\n          -  Has had a prior anti-cancer monoclonal antibody (mAb) =< 4 weeks prior to registration\r\n             or who has not recovered (i.e., =< grade 1 or at baseline level) from adverse events\r\n             due to agents administered more than 4 weeks earlier\r\n\r\n          -  Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy who\r\n             has not recovered (i.e., =< grade 1 or at baseline level) from adverse events due to a\r\n             previously administered agent\r\n\r\n               -  Note: subjects with =< grade 2 neuropathy are an exception to this criterion and\r\n                  may qualify for the study\r\n\r\n          -  Has a known additional malignancy that is progressing or requires active treatment;\r\n             exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the\r\n             skin that has undergone potentially curative therapy or in situ cervical cancer\r\n\r\n          -  Has active autoimmune disease that has required systemic treatment in the past 2 years\r\n             (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive\r\n             drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid\r\n             replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a\r\n             form of systemic treatment\r\n\r\n          -  Has known history of, or any evidence of active, non-infectious pneumonitis\r\n\r\n          -  Has a history or current evidence of any condition, therapy, or laboratory abnormality\r\n             that might confound the results of the trial, interfere with the subject's\r\n             participation for the full duration of the trial, or is not in the best interest of\r\n             the subject to participate, in the opinion of the treating investigator\r\n\r\n          -  Any of the following because this study involves an investigational agent whose\r\n             genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are\r\n             unknown:\r\n\r\n               -  Men or women of childbearing potential who are unwilling to employ adequate\r\n                  contraception\r\n\r\n               -  Is pregnant or breastfeeding, or expecting to conceive or father children within\r\n                  the projected duration of the trial, starting with the pre-screening or screening\r\n                  visit through 120 days after the last dose of trial treatment\r\n\r\n          -  Has received prior therapy with pembrolizumab, nivolumab, avelumab, durvalumab\r\n\r\n          -  Has received a live vaccine within 30 days of planned start of registration; Note:\r\n             seasonal influenza vaccines for injection are generally inactivated flu vaccines and\r\n             are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live\r\n             attenuated vaccines, and are not allowed\r\n\r\n          -  Evidence of pericardial involvement with metastatic breast cancer (effusion,\r\n             pericardial thickening)\r\n\r\n          -  Radiographic evidence of pulmonary lymphangitic spread of metastatic breast cancer\r\n\r\n          -  Evidence of bilateral pleural involvement with metastatic breast cancer (effusions,\r\n             pleural thickening)\r\n\r\n          -  Elevated serum lactate dehydrogenase level (LDH > laboratory ULN) associated with any\r\n             clinical or radiographic evidence of intrathoracic metastatic breast cancer\r\n      ","sponsor":"Mayo Clinic","sponsor_type":"Other","conditions":"Metastatic Malignant Neoplasm in the Bone|Stage IV Breast Cancer AJCC v6 and v7|Triple-Negative Breast Carcinoma","interventions":[{"intervention_type":"Other","name":"Other: Laboratory Biomarker Analysis","description":"Correlative studies"},{"intervention_type":"Biological","name":"Biological: Pembrolizumab","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: Ruxolitinib Phosphate","description":"Given PO"}],"outcomes":[{"outcome_type":"primary","measure":"Maximum tolerated dose","time_frame":"Up to 21 days","description":"Defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients. Assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0."},{"outcome_type":"primary","measure":"Incidence of adverse events","time_frame":"Up to 28 days after last dose of study drug","description":"Assessed by NCI CTCAE version 4.0. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns (by cohort and overall). Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. The rate of grade 3 or higher non-hematologic adverse events, and the rate of grade 4 or higher adverse event (hematologic and non-hematologic) will be computed each with a 95% exact binomial confidence."},{"outcome_type":"secondary","measure":"Best response","time_frame":"Up to 2 years","description":"Defined as best objective status recorded from the start of the treatment until disease progression/recurrence. Assessed by modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease in this patient population (overall and by dose level)."},{"outcome_type":"other","measure":"Assessment of PDJ amplification, PD-L1, PD-L2, JAK2 expression and pSTAT3","time_frame":"Up to 2 years","description":"Will be explored for any associations with response to therapy. Statistical analysis of each biomarker will be primarily descriptive. Continuous biomarker levels will be explored in a graphical manner including mean plots and plots of change and percent change from baseline and other summary measures. Any potential relationships between the baseline level or change in the level of each biomarker and clinical outcome such as overall response will be further analyzed using Wilcoxon rank sum tests or logistic regression methods, as appropriate. Association between a dichotomized biomarker and overall response will be assessed using a chi-squared test. Comparisons with 1-sided p-values =< 0.10 are considered significant."}]}
{"nct_id":"NCT03371199","start_date":"2017-12-01","phase":"N/A","enrollment":21,"brief_title":"The Association Between Hyponatremia and Osteoporosis in Patients With Epilepsy.","official_title":"The Effect of Normalization of Sodium on Bone Markers in Patients With Epilepsy. A Randomized Single-blinded Placebo-controlled Trial.","primary_completion_date":"2018-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-12-31","last_update":"2019-03-28","description":"The study investigates the association between normalization of serum sodium levels and bone markers in patients with epilepsy and chronic hyponatremia. The study is a randomized, single blinded, placebo controlled study where participants will be randomized to either treatment with salt tablets or placebo tablets through 4 months. At the beginning and end of the 4 months bone markers will be measured. The investigators null-hypothesis is that there will be no difference in bone markers before or after the intervention.","other_id":"57353","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Epilepsy requiring treatment for at least 2 years\r\n\r\n          -  Known hyponatremia (2 subsequent s-sodium values < 136 mmol/l)\r\n\r\n          -  Age 18-80 years\r\n\r\n          -  Danish speaking\r\n\r\n          -  Signed form of prior consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnancy and breastfeeding\r\n\r\n          -  Known osteoporosis. DXA scan < -2.5 T-score. Z-score is used for patients 50 years or\r\n             younger.\r\n\r\n          -  Undergoing treatment for osteoporosis\r\n\r\n          -  Undergoing treatment with salt tablets\r\n\r\n          -  Known SIADH\r\n\r\n          -  Severe concomitant disease such as cancer or ischemic heart disease\r\n\r\n          -  Alcohol, drug or substance abuse\r\n      ","sponsor":"Rigshospitalet, Denmark","sponsor_type":"Other","conditions":"Hyponatremia|Metabolic Bone Disease","interventions":[{"intervention_type":"Drug","name":"Drug: Sodium chloride","description":"Sodium chloride tablets, 250 mg"},{"intervention_type":"Drug","name":"Drug: Placebo Oral Tablet","description":"Starch tablets"}],"outcomes":[{"outcome_type":"primary","measure":"CTX1 change","time_frame":"At baseline and after 4 months intervention","description":"bone markers"},{"outcome_type":"secondary","measure":"P1NP change","time_frame":"At baseline and after 4 months intervention","description":"Bone markers"},{"outcome_type":"secondary","measure":"DXA scan change","time_frame":"At baseline and after 4 months intervention","description":"Density measurements"},{"outcome_type":"secondary","measure":"Cognitive function change","time_frame":"At baseline and after 4 months intervention","description":"Epitrack test, scale from 9-49 (9 worst score - 49 best score)"},{"outcome_type":"secondary","measure":"Life quality change","time_frame":"At baseline and after 4 months intervention","description":"Quoli 31, scale from 0-100 (0 lowest life quality - 100 best life quality)"},{"outcome_type":"secondary","measure":"Change in daily pains","time_frame":"At baseline and after 4 months intervention","description":"VAS from 0-10 (0 no pains - 10 maximum pain)"}]}
{"nct_id":"NCT03768882","start_date":"2017-12-01","phase":"Phase 4","enrollment":200,"brief_title":"Comparison of the Efficacy of Intravenous Dexketoprofen and Paracetamol in the Treatment of Sore Throat","official_title":"Comparison of the Efficacy of Intravenous Dexketoprofen and Paracetamol in the Treatment of Pain in Patients Presenting to the Emergency Department With Sore Throat: A Double-Blinded, Randomized, Controlled Trial","primary_completion_date":"2018-07-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-07-30","last_update":"2018-12-10","description":"Currently, paracetamol and nonsteroidal antiinflammatory drugs are widely used by emergency physicians in Turkey for the treatment of sore throat. The objective of the study is compare the efficacy of intravenous dexketoprofen and paracetamol in the treatment of the pain in patients presenting to the emergency department with sore throat","other_id":"2018TPF012","allocation":"Randomized","intervention_model":"Factorial Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with sore throat less than three days\r\n\r\n          -  Patients with at least one of the following:\r\n\r\n          -  According to the throat pain scale, patients with moderate-severe pain,\r\n\r\n          -  At least 1 upper respiratory tract infection (URTI) symptom according URTI\r\n             questionare,\r\n\r\n          -  Objective findings of pharyngeal inflammation (Tonsillopharyngitis evaluation score\r\n             5),\r\n\r\n          -  60 mm or more according to the sore throat sensitivity scale (STSS),\r\n\r\n          -  50 mm and above according to difficulty swallowing scale (DSS),\r\n\r\n          -  33 mm and above according to the swollen throat scale (SwoTS)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients use analgesic last 12 hours\r\n\r\n          -  Patients with severe liver, kidney,pulmonary and cardiac heart failure\r\n\r\n          -  To be Pregnancy and breast-feeding Patients of childbearing age who are not using a\r\n             birth control method\r\n\r\n          -  Patients with an allergy trait (paracetamol and dexketoprofen) Illiterates\r\n\r\n          -  Patients with vision problems\r\n\r\n          -  Patients use antibiotics last 24 hours\r\n\r\n          -  Patients use kinolons last 7 days\r\n\r\n          -  Patienst use lozange,throat spray or menthol containing products last 4 hours\r\n\r\n          -  Hemodynamically unstable patients,Patients with renal transplantation\r\n\r\n          -  Patients with glucose 6 phosphate dehydrogenase (G6PD) deficiency\r\n\r\n          -  Patients with non-controlled hypertension\r\n\r\n          -  Patients with a history of cerebrovascular disease\r\n\r\n          -  Patients with Wolff-Parkinson-White syndrome or accompanying arrhythmias associated\r\n             with conductive stimulus delivery in the heart\r\n      ","sponsor":"Pamukkale University","sponsor_type":"Other","conditions":"Sore Throat","interventions":[{"intervention_type":"Drug","name":"Drug: paracetamol","description":"1000 mg of paracetamol (parol 10mg/ml Mefar, Turkey) intravenous (IV) was given 102 patients"},{"intervention_type":"Drug","name":"Drug: Dexketoprofen","description":"Second group: dexketoprofen 50 MG (Arveles ampoule -E Ulagay -Menarini,Turkey) intravenous (IV) was given 98 patients"}],"outcomes":[{"outcome_type":"primary","measure":"Decreament of the pain","time_frame":"Baseline and 120 minutes","description":"Comparison of the change of sore thorat pain VAS (visual analog scale) and Sore throat relief scale score between the two groups. - (First group Paracetamol and Second Dexketoprofen)"},{"outcome_type":"secondary","measure":"Symptom frequency","time_frame":"Baseline and 120 minutes","description":"Detection of upper respiratory tract infections symptoms frequency by using upper respiratory tract infections questionnaire"}]}
{"nct_id":"NCT03214341","start_date":"2017-12-01","enrollment":24,"brief_title":"Assessment of Mediastinal Masses With Diffusion Weighted MR Imaging","official_title":"Assessment of Mediastinal Masses With Diffusion Weighted MR Imaging","primary_completion_date":"2019-12-01","study_type":"Observational","rec_status":"Unknown status","completion_date":"2019-12-30","last_update":"2017-07-11","description":"Differentiation between benign and malignant mediastinal tumors as well as characterization and grading of malignancy which is essential for treatment planning as well as for prognosis","other_id":"MRIML","observational_model":"Case-Crossover","time_perspective":"Cross-Sectional","sampling_method":"Probability Sample","gender":"All","population":"patients with mediastinal masses","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Any age groups\r\n\r\n          -  diagnosis of mediastinal mass (by Multislice Computed Tomography).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  chemotherapy radiotherapy.\r\n\r\n          -  thoracic surgery.\r\n\r\n          -  cystic mass .\r\n\r\n          -  mass with large amount of necrosis or calcification.\r\n\r\n          -  contraindication of MRI (e.g. pacemakers , claustrophobia).\r\n      ","sponsor":"Assiut University","sponsor_type":"Other","conditions":"Mediastinal Tumor","interventions":[{"intervention_type":"Radiation","name":"Radiation: MRI diffusion","description":"using MRI diffusion to differentiate between benign and malignant mediastinal masses"}],"outcomes":[{"outcome_type":"primary","measure":"sensitivity and specificity of magnetic resonance imaging diffusion in mediastinal masses","time_frame":"up to one month"}]}
{"nct_id":"NCT03338270","start_date":"2017-12-01","enrollment":101,"brief_title":"Clinical Validation Study of Multi-EPI Mix","official_title":"Clinical Validation Study of a Novel Minute MRI Sequence","primary_completion_date":"2018-05-07","study_type":"Observational","rec_status":"Completed","completion_date":"2018-05-07","last_update":"2018-10-05","description":"This study aims to assess the diagnostic validity of a new minute-MRI sequence for neuroradiological evaluation in comparison to conventional MRI.","other_id":"Neuroradiology Karolinska Uni.","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","population":"Neuroradiological indication for brain MRI","criteria":"\n        Inclusion Criteria:\r\n\r\n        - Neuroradiological MRI\r\n\r\n        Exclusion Criteria:\r\n\r\n        - Aborted exam\r\n      ","sponsor":"Karolinska University Hospital","sponsor_type":"Other","conditions":"Brain Diseases","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: MRI","description":"MRI sequence without intravenous contrast"}],"outcomes":[{"outcome_type":"primary","measure":"Diagnostic potential","time_frame":"At MRI scan. Diagnostic accuracy to categorize scan as normal or abnormal on a five point Likert scale compared to abnormal/normal conventional MRI.","description":"Diagnostic performance of lesion conspicuity of new MR sequence compared to conventional sequences"},{"outcome_type":"secondary","measure":"Lesion location determination","time_frame":"At MRI scan","description":"Anatomical localization of abnormality"},{"outcome_type":"secondary","measure":"Lesion classification","time_frame":"At MRI scan","description":"Classification into disease categories"},{"outcome_type":"secondary","measure":"Imaging quality","time_frame":"At MRI scan","description":"Artefacts"},{"outcome_type":"secondary","measure":"Diagnostic imaging quality","time_frame":"At MRI scan","description":"Diagnostic imaging quality"},{"outcome_type":"secondary","measure":"Anatomical conspicuity","time_frame":"At MRI scan","description":"Specified anatomical structures"},{"outcome_type":"secondary","measure":"Multifocality","time_frame":"At MRI scan","description":"Determine multifocal lesion"},{"outcome_type":"secondary","measure":"Ability to rule out diseases","time_frame":"At MRI scan","description":"A list of diseases"},{"outcome_type":"secondary","measure":"Lesion description","time_frame":"At MRI scan","description":"For example effect on brain parenchyma and size"},{"outcome_type":"secondary","measure":"Diagnostic confidence","time_frame":"At MRI scan","description":"Scale"},{"outcome_type":"secondary","measure":"Brain coverage","time_frame":"At MRI scan","description":"Full or lower"},{"outcome_type":"secondary","measure":"Clinical diagnostic summay report","time_frame":"At MRI scan","description":"Text"}]}
{"nct_id":"NCT03290963","start_date":"2017-11-30","phase":"Phase 2","enrollment":0,"brief_title":"Effect of Lithium Versus Placebo in Adults With Treatment-Resistant Depression Who Are Receiving Ketamine","official_title":"Targeting mTOR/GSK3 With Lithium Augmentation to Enhance and Sustain Rapid Antidepressant Actions of Ketamine in Adults With Treatment-Resistant Depression: A Precision Medicine Approach for Psychiatry","primary_completion_date":"2018-12-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2018-12-31","last_update":"2018-08-16","description":"The purpose of this research study is to compare the antidepressant effect of lithium versus placebo in adults receiving ketamine. Lithium is available commercially for depression; ketamine is available commercially and can help the symptoms of depression; however, it has not been approved by the U.S. Food and Drug Administration (FDA) for this use. The FDA has allowed the use of this drug in this research study.","other_id":"17-000819","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":64,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Ability to provide informed consent;\r\n\r\n          -  Current psychiatric inpatient (voluntary only) or outpatient treatment;\r\n\r\n          -  Meets Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5)\r\n             diagnostic criteria for major depressive disorder, bipolar I disorder, or bipolar II\r\n             disorder;\r\n\r\n          -  9-item Patient Health Questionnaire (PHQ-9) total score > 15 at screening and at\r\n             baseline (just prior to first acute phase ketamine infusion);\r\n\r\n          -  Treatment-resistant depression, as defined by failure of at least two previous\r\n             antidepressant or mood stabilizing treatments within the current depressive episode.\r\n             Failed antidepressant or mood stabilizing treatments can include pharmacotherapy for\r\n             depression at an adequate dose for at least 8 weeks, or an acute series of at least 6\r\n             administrations of electroconvulsive therapy (ECT);\r\n\r\n          -  Adequate social support, defined as having at least one individual identified who is\r\n             committed to function as support, including providing transportation to and from\r\n             outpatient ketamine infusion visits;\r\n\r\n          -  Ability to pass a comprehension assessment test related to effects of ketamine and\r\n             trial objectives and criteria.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Diagnosis of schizophrenia, schizoaffective disorder, or active psychotic symptoms;\r\n\r\n          -  On active lithium treatment;\r\n\r\n          -  Serious risk for suicide, as assessed by the evaluating study clinician; a serious\r\n             suicide risk will be considered: (a) an inability to control suicide impulses or\r\n             imminent or unacceptably high risk of suicide in the investigator's judgment; or (b) a\r\n             recent history of suicidal behavior, which is defined as either one or more suicide\r\n             attempts (or interrupted suicide attempts) in the 12 months before study entry; or (c)\r\n             history of serious suicidal behavior, defined as one or more suicide attempts (or\r\n             interrupted attempts) in the last 3 years with a potential lethality judged by the\r\n             evaluating study clinician to have possibly resulted in serious injury or death;\r\n\r\n          -  Ongoing prescription of > 4 mg lorazepam equivalents (total) daily, or morning dosing\r\n             of any benzodiazepine at the time of assessment;\r\n\r\n          -  Currently undergoing ECT, transcranial magnetic stimulation, vagal nerve stimulation,\r\n             or deep brain stimulation as either an acute or maintenance treatment of depression;\r\n\r\n          -  Any active or unstable medical condition judged by the study psychiatrist as\r\n             conferring too great a level of medical risk to allow inclusion in the study;\r\n\r\n          -  Use or abuse of methamphetamine, cocaine, cannabis, or stimulants (prescribed and\r\n             illicit) within the past 12 months;\r\n\r\n          -  Any current abuse or dependence of alcohol or drugs (excluding nicotine and caffeine).\r\n             Note: Persons will be allowed to enroll in this study if their drug or alcohol\r\n             abuse/dependence is in complete (not partial) and sustained (> 1 year) remission;\r\n\r\n          -  History of traumatic brain injury that resulted in loss of consciousness;\r\n\r\n          -  Developmental delay, mental retardation, or intellectual disorder;\r\n\r\n          -  Clinical or self-reported diagnosis of delirium, encephalopathy, or related clinical\r\n             diagnosis within the prior 12 months;\r\n\r\n          -  Cognitive disorder (mild and major categories, per DSM-5);\r\n\r\n          -  Prior participation in another study of ketamine for depression within the prior 6\r\n             months;\r\n\r\n          -  History of either poor antidepressive response to or poor tolerability of ketamine\r\n             (any route of administration) when previously administered for treating symptoms of\r\n             depression;\r\n\r\n          -  History of hypothyroidism unless taking a stable dose of thyroid medication and\r\n             asymptomatic for 6 months;\r\n\r\n          -  Significant unstable medical condition\r\n\r\n          -  Hepatic insufficiency (2.5 X Upper Limit of Normal (ULN) for Aspartate\r\n             Aminotransferase (AST) or Alanine Aminotransferase (ALT)) within 1 year of consent,\r\n             past liver transplant recipient, and/or clinical diagnosis of cirrhosis of the liver;\r\n\r\n          -  History of either poor antidepressive response to or poor tolerability of ketamine\r\n             (any route of administration) when previously administered for treating symptoms of\r\n             depression;\r\n\r\n          -  History of medical condition(s) which are not recommended to be taken concurrently\r\n             with lithium; Current anti-depressive pharmacotherapies will not be allowed during the\r\n             acute phase KET infusions.\r\n\r\n          -  Pregnancy, or nursing;\r\n\r\n          -  Prisoners;\r\n\r\n          -  Involuntary psychiatric hospitalization.\r\n      ","sponsor":"William V. Bobo, M.D.","sponsor_type":"Other","conditions":"Treatment Resistant Depression","interventions":[{"intervention_type":"Drug","name":"Drug: Lithium","description":"Lithium will be dosed in units (LI level > or = 0.4 milliequivalents (mEq)/L)"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo tablets, dosed in units"},{"intervention_type":"Drug","name":"Drug: Ketamine","description":"All subjects will receive 3 IV ketamine infusions of 0.5mg/kg, over 100 min. over 7 days."}],"outcomes":[{"outcome_type":"primary","measure":"Change in Montgomery-Asberg Depression Rating Scale (MADRS)","time_frame":"baseline, at the end of the first infusion (approximately 1 day)","description":"The Montgomery Asberg Depression Scale (MADRS) is a 10-item observer rating scale assessing symptoms of depression. The score ranges from 0 (no depression) to 60 (very depressed)."},{"outcome_type":"primary","measure":"Change in Montgomery-Asberg Depression Rating Scale (MADRS)","time_frame":"baseline, at the end of third infusion (approximately 7 days)","description":"The Montgomery Asberg Depression Scale (MADRS) is a 10-item observer rating scale assessing symptoms of depression. The score ranges from 0 (no depression) to 60 (very depressed)."}]}
{"nct_id":"NCT03266159","start_date":"2017-11-27","phase":"Phase 2","enrollment":0,"brief_title":"A Dose Escalation Study to Investigate the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Clinical Activity of GSK525762 Plus Trametinib in Subjects With Solid Tumors","official_title":"A Phase I/II Open-Label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK525762 Plus Trametinib in Subjects With Small Cell Lung Cancer and Ras-Mutated Solid Tumors","primary_completion_date":"2020-08-19","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2020-08-19","last_update":"2017-12-08","description":"GSK525762 is a novel inhibitor of bromodomain and extraterminal (BET) proteins. Trametinib is a potent inhibitor of the mitogen-activated protein kinase proteins (MEK1 and MEK2). GSK525762 and trametinib are critical for growth and survival of tumor cells. This will be the first study demonstrating the synergistic effect of BET inhibitor and MEK inhibitor administered together against tumor cell growth. This study aims to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of combination of GSK525762 and trametinib when administered concomitantly to subjects with small cell lung cancer (SCLC) and rat sarcoma virus oncogene homolog (Ras) mutated solid tumors. The study will be conducted in two parts; part 1 will consists of dose escalation and dose expansion cohorts and part 2 will consists of four disease specific cohorts (SCLC, Ras-mutated adenocarcinoma [RMAC] of the colon [Ras-mutated colorectal cancer {RMCRC}] and/or rectum, Ras-mutated non small cell lung cancer [RMNSCLC], Ras-mutated pancreatic adenocarcinoma [RMPAC]) and an optional \"basket\" cohort (Ras-pathway activated solid tumors [RAST]). Part 1 will focus on selection of the Part 2 dose based on safety/tolerability, PK, PD, and efficacy. Part 2 will investigate the overall response rate and clinical response. The total duration of study will be approximately three years (nine to twelve months for part 1 and two years for part 2). Approximately 138-156 subjects will be enrolled in the study.","other_id":"204673","allocation":"Non-Randomized","intervention_model":"Sequential Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"A sequential combined therapy of GSK525762 plus trametinib will be given to the subjects. Subjects will receive escalating doses in part 1 and the dose combination selected at the end of part 1 will be provided in part 2.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Written informed consent provided.\r\n\r\n          -  Males and females 18 years old and greater, at the time of signing the informed\r\n             consent.\r\n\r\n          -  Histologically- or cytologically confirmed diagnosis of one of the following; Part 1\r\n             dose escalation cohorts: Advanced (metastatic or non-resectable) SCLC with any\r\n             mutational status, or any solid malignancy that demonstrates an activating mutation in\r\n             Harvey rat sarcoma viral oncogene homolog (HRAS), Kirsten rat sarcoma viral oncogene\r\n             homolog (KRAS), or neuroblastoma RAS viral (v-ras) oncogene homolog (NRAS); Part 1\r\n             dose expansion (PD cohort[s]) and part 2: Advanced (metastatic or non-resectable) SCLC\r\n             with any mutational status, or adenocarcinoma of the colon or rectum, or NSCLC or\r\n             adenocarcinoma of the pancreas, all of which must demonstrate an activating mutation\r\n             in HRAS, KRAS, or NRAS; Part 2 \"basket\" cohort: Advanced (metastatic or\r\n             non-resectable) solid malignancy that demonstrates Ras pathway activation (including\r\n             but not limited to activating BRAF/HRAS/KRAS/NRAS mutation, inactivating neurofibromin\r\n             (NF1) mutation, or evidence of Ras pathway activation by gene expression analysis).\r\n\r\n          -  Disease that did not respond to, or progressed after, at least 1 prior line of\r\n             therapy, or has no generally-accepted standard therapy (dose escalation cohorts and\r\n             optional \"basket\" cohort only).\r\n\r\n          -  Measurable disease during part 1, measurable disease per Response Evaluation Criteria\r\n             in Solid Tumors (RECIST) version (v) 1.1 is recommended but not required. Subjects\r\n             enrolled in part 2 must demonstrate measurable disease per RECIST v1.1.\r\n\r\n          -  PD expansion subjects only: Subjects must consent to pre-dosing and on-therapy tumor\r\n             biopsies and additional sample collection procedures.\r\n\r\n          -  All prior treatment-related toxicities must be National Cancer Institute-Common\r\n             Terminology Criteria for Adverse Events (NCI-CTCAE) v4 <=Grade 1 (except alopecia\r\n             [permitted at any grade]) and peripheral neuropathy (permitted at <=Grade 2) at the\r\n             time of screening.\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.\r\n\r\n          -  Must have adequate organ function as defined by the following values: Absolute\r\n             neutrophil count (ANC) >=1.5 x 10^9/liter (L); hemoglobin >=9 grams per deciliter\r\n             (g/dL) subjects that required transfusion or growth factor need to demonstrate stable\r\n             hemoglobin for 7 days of 9 g/dL; platelets >=100 x 10^9/L; prothrombin time\r\n             (PT)/International normalized ration (INR) and partial thromboplastin time (PTT) <=1.5\r\n             x upper limit of normal (ULN); albumin >=2.5 g/dL; total bilirubin <=1.5 x ULN;\r\n             aspartate transaminase (AST) <=2.5 x ULN; alanine transaminase (ALT) <=2.5 x ULN OR <5\r\n             x ULN; estimated glomerular filtration rate >=50 milliliter (mL)/minute/1.73 m^2;\r\n             ejection fraction>= lower limit of normal (LLN); troponin <=ULN\r\n\r\n          -  Able to swallow and retain orally administered medication.\r\n\r\n          -  A female subject is eligible to participate if she is of: Non-childbearing potential;\r\n             Childbearing potential and agrees to use one of the contraception methods from the\r\n             time of the screening pregnancy test until at least 7 months after the last dose of\r\n             study treatment; All female subjects of childbearing potential must have a negative\r\n             serum pregnancy test <=7 days prior to first dose of study treatment; Female subjects\r\n             who are lactating must discontinue nursing prior to the first dose of study treatment\r\n             and must refrain from nursing throughout the treatment period and for 5 half-lives of\r\n             GSK525762/trametinib or at least 28 days (whichever is longer) following the last dose\r\n             of study treatment.\r\n\r\n          -  Male subjects with female partners of childbearing potential must agree to abide by\r\n             the reproductive guidelines from the first dose of study treatment and for at least 16\r\n             weeks after the last dose of study treatment.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Primary malignancy of the central nervous system or malignancies related to human\r\n             immunodeficiency virus (HIV) or solid organ transplant.\r\n\r\n          -  Prior therapy with any BET inhibitor.\r\n\r\n          -  Recent prior therapy, defined as follows: Any non-biologic anti-cancer drug (either\r\n             investigational or approved) within 14 days or 5 half-lives, whichever is longer,\r\n             prior to the first dose of GSK525762 and trametinib; any nitrosoureas or mitomycin C\r\n             within 42 days prior to the first dose of GSK525762 and trametinib; any biologic\r\n             anti-cancer agent within 28 days prior to the first dose of GSK525762 and trametinib;\r\n             any radiotherapy within 14 days or major surgery within 28 days prior to the first\r\n             dose of GSK525762 and trametinib.\r\n\r\n          -  Therapeutic-dose anticoagulation (e.g., warfarin, heparin) must be discontinued and\r\n             coagulation parameters must be normalized prior to the first dose of GSK525762 and\r\n             trametinib. Low dose (prophylactic) low molecular weight heparin or other\r\n             anticoagulants are permitted.\r\n\r\n          -  Current or planned use of a prohibited medication during treatment with GSK525762 and\r\n             trametinib.\r\n\r\n          -  Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated\r\n             respiratory, hepatic, renal, cardiac disease, or clinically significant bleeding\r\n             episodes). Any serious and/or unstable pre-existing medical (aside from malignancy)\r\n             condition, psychiatric disorder, or other conditions that could interfere with\r\n             subject's safety, obtaining informed consent or compliance to the study procedures, in\r\n             the opinion of the investigator.\r\n\r\n          -  Symptomatic or untreated leptomeningeal or brain metastases or spinal cord\r\n             compression. Subjects with a history of central nervous system (CNS) involvement may\r\n             be enrolled so long as all of the following requirements are met: Subjects must have\r\n             received definitive therapy for the CNS involvement (e.g., surgery, radiotherapy, or\r\n             stereotactic radiosurgery [i.e., gamma knife or equivalent]); At least 28 days must\r\n             have elapsed since the CNS-directed therapy; All symptoms and AEs from the\r\n             CNS-directed therapy must have resolved to <=Grade 1; Lesion stability must be\r\n             demonstrated by serial imaging spaced at least 28 days apart; If the subject remains\r\n             on corticosteroids, the dose must be stable to decreasing for the 28-day interval\r\n             prior to study Day 1; The subject does not receive any enzyme-inducing anticonvulsants\r\n             (EIACs) from 14 days prior to study Day 1 until the End of Treatment.\r\n\r\n          -  Cardiac abnormalities as evidenced by any of the following: Baseline QTcF interval\r\n             >450 millisecond (msec); Clinically significant conduction abnormalities or\r\n             arrhythmias; Presence of cardiac pacemaker or defibrillator with a paced ventricular\r\n             rhythm limiting ECG analysis; History or evidence of current >=Class II congestive\r\n             heart failure as defined by New York Heart Association (NYHA); History of acute\r\n             coronary syndromes (including unstable angina and myocardial infarction), coronary\r\n             angioplasty, or stenting within the past 3 months. Subjects with a history of stent\r\n             placement requiring ongoing antithrombotic therapy (e.g., clopidogrel, prasugrel) will\r\n             not be permitted to enroll.\r\n\r\n          -  Current active liver or biliary disease (with the exception of Gilbert's syndrome or\r\n             asymptomatic gallstones, liver metastases, or otherwise stable chronic liver disease\r\n             per investigator assessment).\r\n\r\n          -  Presence of hepatitis B surface antigen (HBsAg) or positive hepatitis C antibody test\r\n             result at screening or within 3 months prior to first dose of study treatment.\r\n\r\n          -  History of known HIV infection or positive HIV test at screening.\r\n\r\n          -  Any serious known immediate or delayed hypersensitivity reaction(s) to GSK525762 or\r\n             trametinib, or idiosyncrasy to drugs chemically related to the investigational drugs.\r\n\r\n          -  Subjects with a history of known bleeding disorder(s) or history of clinically\r\n             significant (as judged by the investigator and medical monitor) hemorrhage (e.g., GI,\r\n             neurologic, pulmonary) within the past 6 months.\r\n\r\n          -  History of retinal vein occlusion.\r\n\r\n          -  History of pneumonitis or interstitial lung disease.\r\n\r\n          -  Any clinically significant gastrointestinal abnormalities that may alter absorption of\r\n             oral medications, (e.g., malabsorption syndrome).\r\n      ","sponsor":"GlaxoSmithKline","sponsor_type":"Industry","conditions":"Solid Tumours","interventions":[{"intervention_type":"Drug","name":"Drug: GSK525762 Besylate tablets","description":"GSK525762 Besylate film coated tablets will be available as a 20 mg tablet strength, yellowish pink in color, round and biconvex with no markings. It will be administered with 240mL of liquid."},{"intervention_type":"Drug","name":"Drug: Trametinib tablets","description":"Trametinib film coated tablets will be available as 0.5 mg and 2 mg dose strengths. Trametinib 0.5 mg will be yellow colored, modified oval, biconvex, tablets with 'GS' debossed on one face and 'TFC' on the opposing face.\r\nTrametinib 2 mg will be pink colored, round, biconvex tablets with 'GS' debossed on one face and 'HMJ' on the opposing face. Doses will be taken at least 1 hour before or at least 2 hours after a meal."}],"outcomes":[{"outcome_type":"primary","measure":"Part 2: Number of subjects with abnormal clinical chemistry laboratory tests","time_frame":"Up to 24 months","description":"Clinical chemistry parameters will be analyzed as a measure of safety."},{"outcome_type":"primary","measure":"Part 2: Number of subjects with abnormal hematology laboratory tests","time_frame":"Up to 24 months","description":"Hematology parameters will be analyzed as a measure of safety."},{"outcome_type":"primary","measure":"Part 2: Number of subjects with abnormal routine urinalysis laboratory tests","time_frame":"Up to 24 months","description":"Urinalysis will be carried out as a measure of safety."},{"outcome_type":"primary","measure":"Part 1: Area under the plasma concentration time curve from time 0 to last time of quantifiable concentration (AUC [0-T]) of GSK525762 and trametinib","time_frame":"Pre-dose,30minutes ±5minutes,1 hour±5minutes,2hours±10 minutes,3hours±10minutes, 4hours±15minutes,6±1hour,8±1hour, and 24±2hours at Day1 Week1;Day1 Week3. Pre-dose;1hour±10minutes post-dose at Day1 Week2,Day1 Week 4;every 8 Weeks from Week8 to Week52","description":"Blood samples will be collected at the indicated time points for pharmacokinetic analysis and concentration of GSK525762 and trametinib will be determined in plasma."},{"outcome_type":"primary","measure":"Part 1: Pre-dose (trough) concentration at the end of a dosing interval (Ctau) of GSK525762 and trametinib","time_frame":"Pre-dose,30minutes ±5minutes,1 hour±5minutes,2hours±10 minutes,3hours±10minutes, 4hours±15minutes,6±1hour,8±1hour, and 24±2hours at Day1 Week1;Day1 Week3. Pre-dose;1hour±10minutes post-dose at Day1 Week2,Day1 Week 4;every 8 Weeks from Week8 to Week52","description":"Blood samples will be collected at the indicated time points for pharmacokinetic analysis and concentration of GSK525762 and trametinib will be determined in plasma."},{"outcome_type":"primary","measure":"Part 1: Number of subjects with adverse events (AEs) and serious adverse events (SAEs)","time_frame":"Up to 12 months","description":"An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgement will be categorized as SAE."},{"outcome_type":"primary","measure":"Part 1: Number of subjects with dose limiting toxicities (DLT) as a measure of safety","time_frame":"Up to 12 months","description":"DLT is defined by the occurrence of severe toxicities during the first cycle of cancer therapy. An event will be considered a DLT if it occurs within the first 21 days of treatment and meets the DLT criteria."},{"outcome_type":"primary","measure":"Part 1: Maximum observed plasma concentration (Cmax) of GSK525762 and trametinib","time_frame":"Pre-dose,30minutes ±5minutes,1 hour±5minutes,2hours±10 minutes,3hours±10minutes, 4hours±15minutes,6±1hour,8±1hour, and 24±2hours at Day1 Week1;Day1 Week3. Pre-dose;1hour±10minutes post-dose at Day1 Week2,Day1 Week 4;every 8 Weeks from Week8 to Week52","description":"Blood samples will be collected at the indicated time points for pharmacokinetic analysis and concentration of GSK525762 and trametinib will be determined in plasma."},{"outcome_type":"primary","measure":"Part 1: Time to Cmax (Tmax) of GSK525762 and trametinib","time_frame":"Pre-dose,30minutes ±5minutes,1 hour±5minutes,2hours±10 minutes,3hours±10minutes, 4hours±15minutes,6±1hour,8±1hour, and 24±2hours at Day1 Week1;Day1 Week3. Pre-dose;1hour±10minutes post-dose at Day1 Week2,Day1 Week 4;every 8 Weeks from Week8 to Week52","description":"Blood samples will be collected at the indicated time points for pharmacokinetic analysis and concentration of GSK525762 and trametinib will be determined in plasma."},{"outcome_type":"primary","measure":"Part 1: Change from Baseline in the phosphorylation of extracellular signal-regulated kinase (pERK) levels","time_frame":"Baseline and up to Week 3","description":"The pERK levels will be assessed in pre-therapy and on-therapy tumor samples."},{"outcome_type":"primary","measure":"Part 1: Change from Baseline circulating protein or ribonucleic acid (RNA) biomarkers","time_frame":"Baseline and up to Week 3","description":"The circulating protein or RNA biomarkers including to monocyte chemoattractant protein-1 (MCP-1) will be assessed in pre-therapy and on-therapy blood samples."},{"outcome_type":"primary","measure":"Part 1: Change from Baseline transcriptional levels and mitogen activated protein (MAP) kinase signaling","time_frame":"Baseline and up to Week 3","description":"The transcriptional levels and MAP kinase signaling will be assessed in pre-therapy and on-therapy tumor and/or blood samples."},{"outcome_type":"primary","measure":"Part 1: Overall response rate (ORR)","time_frame":"Up to 12 months","description":"ORR is defined as the percentage of subjects with a confirmed complete response (CR) or partial response (PR) at any time as per disease-specific criteria."},{"outcome_type":"primary","measure":"Part 1: Disease control rate (DCR)","time_frame":"Up to 12 months","description":"DCR is defined as the percentage of subjects with a confirmed CR, PR, or SD at any time as per disease-specific criteria."},{"outcome_type":"primary","measure":"Part 1: Duration of response (DOR)","time_frame":"Up to 12 months","description":"The DOR is defined as, in the subset of subjects who show a confirmed CR or PR, the time from first documented evidence of CR or PR until the first documented sign of disease progression or death."},{"outcome_type":"primary","measure":"Part 2: ORR","time_frame":"Up to 24 months","description":"ORR is defined as the percentage of subjects with a confirmed CR or PR at any time as per disease-specific criteria."},{"outcome_type":"primary","measure":"Part 2: Clinical response","time_frame":"Up to 24 months","description":"Clinical response is defined as confirmed ORR as per standard evaluation criteria. ORR is the percentage of subjects with a confirmed CR or PR at any time as per disease-specific criteria."},{"outcome_type":"primary","measure":"Part 2: Number of subjects with AEs and SAEs","time_frame":"Up to 24 months","description":"An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgement will be categorized as SAE."},{"outcome_type":"primary","measure":"Part 2: Number of subjects with dose reductions or delays as a measure of safety","time_frame":"Up to 24 months","description":"Dose reductions or delays will be evaluated until the end of treatment."},{"outcome_type":"primary","measure":"Part 2: Number of subjects withdrawals due to toxicities","time_frame":"Up to 24 months","description":"Withdrawals will be collected until the end of treatment."},{"outcome_type":"primary","measure":"Part 2: Number of subjects with abnormal systolic blood pressure (SBP) and diastolic blood pressure (DBP) as a measure of safety","time_frame":"Up to 24 months","description":"Systolic and diastolic blood pressure will be measured in semi-supine position after 5 minutes of rest."},{"outcome_type":"primary","measure":"Part 2: Number of subjects with abnormal pulse rate","time_frame":"Up to 24 months","description":"Pulse rate will be measured in a semi-supine position after 5 minutes of rest.."},{"outcome_type":"primary","measure":"Part 2: Number of subjects with abnormal respiratory rate","time_frame":"Up to 24 months","description":"Respiratory rate will be measured in a semi-supine position after 5 minutes of rest."},{"outcome_type":"primary","measure":"Part 2: Number of subjects with abnormal body temperature","time_frame":"Up to 24 months","description":"Body temperature will be measured in a semi-supine position after 5 minutes of rest."},{"outcome_type":"primary","measure":"Part 2: Number of subjects with abnormal electrocardiogram (ECG) findings","time_frame":"Up to 24 months","description":"Triplicate 12-lead ECGs will be obtained at each time point using an ECG machine to measure PR, QRS, QT, and Corrected QT interval (QTc)."},{"outcome_type":"primary","measure":"Part 2: Number of subjects with cardiotoxicity and gastrointestinal (GI) toxicity","time_frame":"Up to 24 months","description":"Echocardiography (ECHO) or multigated acquisition (MUGA) scan will be performed to assess cardiotoxicity and GI effects will be monitored."},{"outcome_type":"primary","measure":"Part 2: AUC [0-T] of GSK525762 and trametinib","time_frame":"Pre-dose, and 0.5hour±5 minutes, 1-2 hours, 4-6hours post-dose at Day1 Week 1, Day1 Week3, and every 8 Weeks from Week8 to Week52","description":"Blood samples will be collected at the indicated time points for pharmacokinetic analysis and concentration of GSK525762 AND TRAMETINIB will be determined in plasma."},{"outcome_type":"primary","measure":"Part 2: Ctau of GSK525762 and trametinib","time_frame":"Pre-dose, and 0.5hour±5 minutes, 1-2 hours, 4-6hours post-dose at Day1 Week 1, Day1 Week3, and every 8 Weeks from Week8 to Week52","description":"Blood samples will be collected at the indicated time points for pharmacokinetic analysis and concentration of GSK525762 and trametinib will be determined in plasma."},{"outcome_type":"primary","measure":"Part 2: Cmax of GSK525762 and trametinib","time_frame":"Pre-dose, and 0.5hour±5 minutes, 1-2 hours, 4-6hours post-dose at Day1 Week 1, Day1 Week3, and every 8 Weeks from Week8 to Week52","description":"Blood samples will be collected at the indicated time points for pharmacokinetic analysis and concentration of GSK525762 and trametinib will be determined in plasma."},{"outcome_type":"primary","measure":"Part 2: Tmax of GSK525762 and trametinib","time_frame":"Pre-dose, and 0.5hour±5 minutes, 1-2 hours, 4-6hours post-dose at Day1 Week 1, Day1 Week3, and every 8 Weeks from Week8 to Week52","description":"Blood samples will be collected at the indicated time points for pharmacokinetic analysis and concentration of GSK525762 and trametinib will be determined in plasma."},{"outcome_type":"primary","measure":"Part 2: Change from Baseline in the pERK levels","time_frame":"Baseline and up to Week 3","description":"The pERK levels will be assessed in pre-therapy and on-therapy tumor samples."},{"outcome_type":"primary","measure":"Part 2: Change from Baseline circulating protein or RNA biomarkers","time_frame":"Baseline and up to Week 3","description":"The circulating protein or RNA biomarkers including to MCP-1 will be assessed in pre-therapy and on-therapy blood samples."},{"outcome_type":"primary","measure":"Part 2: Change from Baseline transcriptional levels and MAP kinase signaling","time_frame":"Baseline and up to Week 3","description":"The transcriptional levels and MAP kinase signaling will be assessed in pre-therapy and on-therapy tumor and/or blood samples."},{"outcome_type":"secondary","measure":"Part 1: Number of subjects with AEs and SAEs","time_frame":"Up to 12 months","description":"An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgement will be categorized as SAE."},{"outcome_type":"secondary","measure":"Part 1: Number of subjects with dose reductions or delays as a measure of safety","time_frame":"Up to 12 months","description":"Subjects will be evaluated for dose reductions and delays. An event will be considered a DLT if it occurs within the first 21 days of treatment and meets the DLT criteria."},{"outcome_type":"secondary","measure":"Part 1: Number of subject withdrawals due to toxicities","time_frame":"Up to 12 months","description":"DLT is defined by the occurrence of severe toxicities during the first cycle of cancer therapy. An event will be considered a DLT if it occurs within the first 21 days of treatment and meets the DLT criteria."},{"outcome_type":"secondary","measure":"Part 1: Number of subjects with abnormal clinical chemistry laboratory tests","time_frame":"Up to 12 months","description":"Clinical chemistry parameters will be analyzed as a measure of safety."},{"outcome_type":"secondary","measure":"Part 1: Number of subjects with abnormal hematology laboratory tests","time_frame":"Up to 12 months","description":"Hematology parameters will be analyzed as a measure of safety."},{"outcome_type":"secondary","measure":"Part 1: Number of subjects with abnormal routine urinalysis laboratory tests","time_frame":"Up to 12 months","description":"Urinalysis will be carried out as a measure of safety."},{"outcome_type":"secondary","measure":"Part 1: Number of subjects with abnormal SBP and DBP as a measure of safety","time_frame":"Up to 12 months","description":"Systolic and diastolic blood pressure will be measured in semi-supine position after 5 minutes of rest."},{"outcome_type":"secondary","measure":"Part 1: Number of subjects with abnormal pulse rate","time_frame":"Up to 12 months","description":"Pulse rate will be measured in a semi-supine position after 5 minutes of rest."},{"outcome_type":"secondary","measure":"Part 1: Number of subjects with abnormal respiratory rate","time_frame":"Up to 12 months","description":"Respiratory rate will be measured in a semi-supine position after 5 minutes of rest."},{"outcome_type":"secondary","measure":"Part 1: Number of subjects with abnormal body temperature","time_frame":"Up to 12 months","description":"Body temperature will be measured in a semi-supine position after 5 minutes of rest."},{"outcome_type":"secondary","measure":"Part 1: Number of subjects with abnormal ECG findings","time_frame":"Up to 12 months","description":"Triplicate 12-lead ECGs will be obtained at each time point using an ECG machine to measure PR, QRS, QT, and QTc."},{"outcome_type":"secondary","measure":"Part 1: Number of subjects with cardiotoxicity and GI toxicity","time_frame":"Up to 12 months","description":"Echocardiography (ECHO) or multigated acquisition (MUGA) scan will be performed to assess cardiotoxicity and GI effects will be monitored."},{"outcome_type":"secondary","measure":"Part 1: (AUC [0-T]) of GSK525762 and trametinib","time_frame":"Pre-dose,30minutes ±5minutes,1 hour±5minutes,2hours±10 minutes,3hours±10minutes, 4hours±15minutes,6±1hour,8±1hour, and 24±2hours at Day1 Week1;Day1 Week3. Pre-dose;1hour±10minutes post-dose at Day1 Week2,Day1 Week 4;every 8 Weeks from Week8 to Week52","description":"Blood samples will be collected at the indicated time points for pharmacokinetic analysis and concentration of GSK525762 and trametinib will be determined in plasma."},{"outcome_type":"secondary","measure":"Part 1: Ctau of GSK525762 and trametinib","time_frame":"Pre-dose,30minutes ±5minutes,1 hour±5minutes,2hours±10 minutes,3hours±10minutes, 4hours±15minutes,6±1hour,8±1hour, and 24±2hours at Day1 Week1;Day1 Week3. Pre-dose;1hour±10minutes post-dose at Day1 Week2,Day1 Week 4;every 8 Weeks from Week8 to Week52","description":"Blood samples will be collected at the indicated time points for pharmacokinetic analysis and concentration of GSK525762 and trametinib will be determined in plasma."},{"outcome_type":"secondary","measure":"Part 1: Cmax of GSK525762 and trametinib","time_frame":"Pre-dose,30minutes ±5minutes,1 hour±5minutes,2hours±10 minutes,3hours±10minutes, 4hours±15minutes,6±1hour,8±1hour, and 24±2hours at Day1 Week1;Day1 Week3. Pre-dose;1hour±10minutes post-dose at Day1 Week2,Day1 Week 4;every 8 Weeks from Week8 to Week52","description":"Blood samples will be collected at the indicated time points for pharmacokinetic analysis and concentration of GSK525762 and trametinib will be determined in plasma."},{"outcome_type":"secondary","measure":"Part 1: Tmax of GSK525762 and trametinib","time_frame":"Pre-dose,30minutes ±5minutes,1 hour±5minutes,2hours±10 minutes,3hours±10minutes, 4hours±15minutes,6±1hour,8±1hour, and 24±2hours at Day1 Week1;Day1 Week3. Pre-dose;1hour±10minutes post-dose at Day1 Week2,Day1 Week 4;every 8 Weeks from Week8 to Week52","description":"Blood samples will be collected at the indicated time points for pharmacokinetic analysis and concentration of GSK525762 and trametinib will be determined in plasma."},{"outcome_type":"secondary","measure":"Part 1: ORR","time_frame":"Up to 12 months","description":"ORR is defined as the percentage of subjects with a CR or PR at any time as per disease-specific criteria."},{"outcome_type":"secondary","measure":"Part 1: DCR","time_frame":"Up to 12 months","description":"DCR is defined as the percentage of subjects with a confirmed CR, PR, or SD at any time as per disease-specific criteria."},{"outcome_type":"secondary","measure":"Part 1: DOR","time_frame":"Up to 12 months","description":"The DOR is defined as, in the subset of subjects who show a confirmed CR or PR, the time from first documented evidence of CR or PR until the first documented sign of disease progression or death."},{"outcome_type":"secondary","measure":"Part 1: Progression-free survival (PFS)","time_frame":"Up to 12 months","description":"PFS defined as the time from first dose of study treatment until the disease progression or death due to any cause."},{"outcome_type":"secondary","measure":"Part 2: PFS","time_frame":"Up to 24 months","description":"PFS defined as the time from first dose of study treatment until the disease progression or death due to any cause."},{"outcome_type":"secondary","measure":"Part 2: DOR","time_frame":"Up to 24 months","description":"The DOR is defined as, in the subset of subjects who show a confirmed CR or PR, the time from first documented evidence of CR or PR until the first documented sign of disease progression or death."},{"outcome_type":"secondary","measure":"Part 2: DCR","time_frame":"Up to 24 months","description":"DCR is defined as the percentage of subjects with a confirmed CR, PR, or SD at any time as per disease-specific criteria."},{"outcome_type":"secondary","measure":"Part 2 :Concentrations of GSK525762 and its relevant metabolite(s) and trametinib following repeat dose oral administration.","time_frame":"Pre-dose, and 0.5hour±5 minutes, 1-2 hours, 4-6hours post-dose at Day1 Week 1, Day1 Week3, and every 8 Weeks from Week8 to Week52","description":"Plasma samples will be collected at the indicated time points to measure concentrations of GSK525762 and its relevant metabolite(s) and trametinib following repeat dose oral administration."}]}
{"nct_id":"NCT03316976","start_date":"2017-11-22","phase":"Phase 1","enrollment":40,"brief_title":"A Study to Evaluate the Pharmacokinetics of Dexlansoprazole 30 Milligram (mg) and 60 mg Delayed-release Capsules in Healthy Chinese Participants","official_title":"A Phase 1, Single-Center, Open-Label, 2-Arm Parallel Group, Single-Dose Study to Evaluate the Pharmacokinetics of Dexlansoprazole 30 mg and 60 mg Delayed-Release Capsules in Healthy Chinese Subjects","primary_completion_date":"2018-02-08","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-02-08","last_update":"2019-05-10","description":"The purpose of this study is to assess the pharmacokinetics after a single dose of dexlansoprazole 30 and 60 mg delayed-release capsules in healthy Chinese participants.","other_id":"TAK-390MR_106","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Is a healthy adult man or woman of Chinese descent.\r\n\r\n          2. Is aged 18 to 45 years, inclusive, at the time of informed consent and study\r\n             medication dose.\r\n\r\n          3. Weighs at least 50 kilogram (kg) and has a body mass index (BMI) from 19.0 to 26.0\r\n             kilogram per square meter (kg/m^2), inclusive at Screening Visit.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Has a known hypersensitivity to any component of the formulation of dexlansoprazole or\r\n             other drug with the same mechanism of action (including lansoprazole, omeprazole,\r\n             esomeprazole, rabeprazole, ilaprazole, or pantoprazole), or related compounds.\r\n\r\n          2. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol\r\n             abuse within 1 year prior to the Screening visit or is unwilling to agree to abstain\r\n             from alcohol for 48 hours prior to Check-in (Day -1) throughout the confinement and\r\n             for 48 hours prior to each clinic visit and drugs throughout the study.\r\n\r\n          3. Has used nicotine-containing products (including but not limited to cigarettes, pipes,\r\n             cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to\r\n             Check-in (Day -1) or is unwilling to abstain from these products for the duration of\r\n             the study.\r\n\r\n          4. Has poor peripheral venous access.\r\n\r\n          5. Has donated blood products (such as plasma), whole blood or had a significant blood\r\n             loss (450 millimeter [mL]) within 56 days of Day 1.\r\n      ","sponsor":"Takeda","sponsor_type":"Industry","conditions":"Healthy Volunteers","interventions":[{"intervention_type":"Drug","name":"Drug: Dexlansoprazole","description":"Dexlansoprazole delayed-release capsule."}],"outcomes":[{"outcome_type":"primary","measure":"Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole","time_frame":"Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose"},{"outcome_type":"primary","measure":"AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Dexlansoprazole","time_frame":"Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose"},{"outcome_type":"primary","measure":"AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Dexlansoprazole","time_frame":"Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose"}]}
{"nct_id":"NCT04742517","start_date":"2017-11-20","phase":"Phase 1","enrollment":102,"brief_title":"A Study of MA-0217 (ASP1128) in Healthy Adult Subjects and Healthy Elderly Subjects","official_title":"A Phase 1 Combined Single and Multiple Ascending Intravenous Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MA-0217 in Healthy Adult Subjects and Healthy Elderly Subjects","primary_completion_date":"2018-09-07","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-09-07","last_update":"2021-02-08","description":"The primary purpose of this study is to evaluate the safety and tolerability of single ascending intravenous doses of ASP1128 in healthy adult male and female subjects and multiple ascending intravenous doses of ASP1128 in healthy adult male and female subjects and healthy elderly male and female subjects. This study will also evaluate the pharmacokinetics and the effect on the QT interval using Fridericia's correction formula (QTcF) in these subjects.","other_id":"1128-CL-0101","allocation":"Randomized","intervention_model":"Sequential Assignment","primary_purpose":"Basic Science","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  For adult subjects (cohorts 1.1 to 1.8 and cohorts 2.1 to 2.5):\r\n\r\n               -  Subject is a healthy adult male or female subject 18 to 55 years of age,\r\n                  inclusive at screening.\r\n\r\n               -  Subject has a body mass index (BMI) range of 18.5 to 32.0 kg/m^2, inclusive and\r\n                  weighs at least 50 kg at screening.\r\n\r\n          -  For elderly subjects (cohort 2.6):\r\n\r\n               -  Subject is a healthy elderly male or female subject  65 years of age at\r\n                  screening.\r\n\r\n               -  Subject has a BMI range of 18.5 to 32.0 kg/m^2, inclusive and weighs at least 50\r\n                  kg at screening.\r\n\r\n          -  Subject is considered an adult according to local regulation at the time of signing\r\n             informed consent.\r\n\r\n          -  Female subject must either be of nonchildbearing potential:\r\n\r\n               -  Postmenopausal (defined as at least 1 year without any menses for which there is\r\n                  no other obvious pathological or physiological cause) prior to screening, or\r\n\r\n               -  Documented surgically sterile (e.g., hysterectomy, bilateral salpingectomy or\r\n                  bilateral oophorectomy), OR, if of childbearing potential:\r\n\r\n               -  Agree not to try to become pregnant during the study and for 28 days after the\r\n                  final study drug administration\r\n\r\n               -  Have a negative blood pregnancy test at screening and a negative urine pregnancy\r\n                  test on day -1\r\n\r\n               -  If heterosexually active, agree to consistently use 1 form of highly effective\r\n                  birth control starting at screening and throughout the study period and for 28\r\n                  days after the final study drug administration\r\n\r\n          -  Female subject must agree not to breastfeed starting at screening and throughout the\r\n             study period and for 28 days after the final study drug administration.\r\n\r\n          -  Female subject must not donate ova starting at screening and throughout the study\r\n             period and for 28 days after the final study drug administration.\r\n\r\n          -  A sexually active male subject with female partner(s) who is(are) of childbearing\r\n             potential is eligible for the study if:\r\n\r\n               -  Agree to use a male condom starting at screening and continue throughout study\r\n                  treatment and for 28 days after the final study drug administration.\r\n\r\n               -  If the male subject has not had a vasectomy or is not sterile, their female\r\n                  partner(s) is(are) utilizing 1 form of highly effective birth control starting at\r\n                  screening and continue throughout study treatment and for 28 days after the male\r\n                  subject receives their final study drug administration.\r\n\r\n          -  Male subject must not donate sperm starting at screening and throughout the study\r\n             period and for 28 days after the final study drug administration.\r\n\r\n          -  Male subject with a pregnant or breastfeeding partner(s) must agree to remain\r\n             abstinent or use a condom for the duration of the pregnancy or time partner(s) is(are)\r\n             breastfeeding throughout the study period and for 28 days after the final study drug\r\n             administration.\r\n\r\n          -  Subject agrees not to participate in another interventional study while participating\r\n             in the present study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subject has received investigational drug within 28 days or 5 half-lives, whichever is\r\n             longer, prior to screening.\r\n\r\n          -  Subject has any condition which makes the subject unsuitable for study participation.\r\n\r\n          -  Female subject who has been pregnant within 6 months prior to screening or\r\n             breastfeeding within 3 months prior to screening.\r\n\r\n          -  Subject has a known or suspected hypersensitivity to ASP1128 or any components of the\r\n             formulation used.\r\n\r\n          -  Subject has had previous exposure with ASP1128.\r\n\r\n          -  Subject has unsuitable or difficult venous access to support the intravenous\r\n             infusion(s) and/or required blood draws.\r\n\r\n          -  Subject has any of the liver function tests (LFTs; aspartate aminotransferase [AST],\r\n             alanine aminotransferase [ALT], alkaline phosphatase [ALP], gamma-glutamyl transferase\r\n             and total bilirubin [TBL]) above the upper limit of normal (ULN) at screening or on\r\n             day -1. In such a case, the assessment may be repeated once.\r\n\r\n          -  Subject has total creatine kinase (CK) > 1.5  ULN or cardiac troponin I above the ULN\r\n             at day -1.\r\n\r\n          -  Subject has any clinically significant history of allergic conditions (including drug\r\n             allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated,\r\n             asymptomatic, seasonal allergies) prior to study drug administration.\r\n\r\n          -  Subject has any history or evidence of any clinically significant cardiovascular,\r\n             gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic,\r\n             urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major\r\n             disease or malignancy.\r\n\r\n          -  Subject has/had febrile illness or symptomatic, viral, bacterial (including upper\r\n             respiratory infection), or fungal (noncutaneous) infection within 1 week prior to day\r\n             -1.\r\n\r\n          -  Subject has any clinically significant abnormality following the physical examination,\r\n             electrocardiogram (ECG) and protocol-defined clinical laboratory tests at screening or\r\n             on day -1.\r\n\r\n          -  Subject has a mean pulse < 45 or > 90 bpm; mean systolic blood pressure (SBP) > 140\r\n             mmHg; mean diastolic blood pressure (DBP) > 90 mmHg (measurements taken in triplicate\r\n             after subject has been resting in the supine position for at least 5 minutes; pulse\r\n             will be measured automatically) at screening or on day -1. For elderly subjects the\r\n             following criteria apply: SBP > 160 mmHg, DBP > 100 mmHg. If the mean blood pressure\r\n             exceeds the limits above, 1 additional triplicate can be taken.\r\n\r\n          -  Subject has a mean QT interval using Fridericia's correction formula (QTcF) interval\r\n             of > 430 msec (for males) and > 450 msec (for females) at screening or on day -1. If\r\n             the mean QTcF exceeds the limits above, 1 additional triplicate ECG can be taken.\r\n\r\n          -  Subject has used any prescribed or nonprescribed drugs (including vitamins, natural\r\n             and herbal remedies, e.g., St. John's Wort) in the 2 weeks prior to study drug\r\n             administration, except for occasional use of acetaminophen (up to 2 g/day), hormonal\r\n             contraceptives and hormone replacement therapy.\r\n\r\n          -  Subject has used any peroxisome proliferator-activated receptor (PPAR) ligands such as\r\n             fibrates and thiazolidinediones, including self-medication obtained via the internet,\r\n             in the 4 weeks prior to study drug administration.\r\n\r\n          -  Subject has smoked or has used tobacco-containing products and nicotine or\r\n             nicotine-containing products in the past 6 months prior to screening.\r\n\r\n          -  Subject has a history of consuming > 14 units of alcoholic beverages per week within 6\r\n             months prior to screening or has a history of alcoholism or drug/chemical/substance\r\n             abuse within past 2 years prior to screening (Note: 1 unit = 12 ounces of beer, 4\r\n             ounces of wine or 1 ounce of spirits/hard liquor) or the subject tests positive for\r\n             alcohol or drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids,\r\n             cocaine and opiates) at screening or on day -1.\r\n\r\n          -  Subject has used any drugs of abuse (amphetamines, barbiturates, benzodiazepines,\r\n             cannabinoids, cocaine and opiates) within 3 months prior to day -1.\r\n\r\n          -  Subject has used any inducer of metabolism (e.g., barbiturates and rifampin) in the 3\r\n             months prior to day -1.\r\n\r\n          -  Subject has had significant blood loss, donated  1 unit (450 mL) of blood or received\r\n             a transfusion of any blood or blood products within 60 days or donated plasma within 7\r\n             days prior to day -1.\r\n\r\n          -  Subject has a positive serology test for hepatitis B surface antigen (HBsAg),\r\n             hepatitis B core (HBc) antibodies, hepatitis A virus (HAV) antibodies (immunoglobulin\r\n             M [IgM]), hepatitis C virus (HCV) antibodies or antibodies to human immunodeficiency\r\n             virus (HIV) type 1 and/or type 2 at screening.\r\n\r\n          -  Subject is an employee of Astellas, Mitobridge or designated contract research\r\n             organization (CRO).\r\n      ","sponsor":"Astellas Pharma Europe B.V.","sponsor_type":"Industry","conditions":"Healthy Volunteers","interventions":[{"intervention_type":"Drug","name":"Drug: ASP1128","description":"Intravenous"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Intravenous"}],"outcomes":[{"outcome_type":"primary","measure":"Number of participants with Adverse Events (AEs) in Part 1","time_frame":"Up to Day 16","description":"An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.\r\nIn order to identify any events that may be associated with study procedures and could lead to a change in the conduct of the study, AEs will be collected even if the subject has not received study drug treatment."},{"outcome_type":"primary","measure":"Number of participants with laboratory value abnormalities and/or AEs in Part 1","time_frame":"Up to Day 16","description":"Number of participants with potentially clinically significant laboratory values."},{"outcome_type":"primary","measure":"Number of participants with vital sign abnormalities and/or AEs in Part 1","time_frame":"Up to Day 16","description":"Number of participants with potentially clinically significant vital sign values."},{"outcome_type":"primary","measure":"Number of participants with electrocardiogram (ECG) abnormalities and/or AEs in Part 1","time_frame":"Up to Day 16","description":"Number of participants with potentially clinically significant 12-ECG values."},{"outcome_type":"primary","measure":"Number of participants with real-time cardiac monitoring (cardiac telemetry) abnormalities and/or AEs in Part 1","time_frame":"On Day 1","description":"Number of participants with potentially clinically significant cardiac telemetry values."},{"outcome_type":"primary","measure":"Number of participants with AEs in Part 2","time_frame":"Up to Day 19","description":"An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.\r\nIn order to identify any events that may be associated with study procedures and could lead to a change in the conduct of the study, AEs will be collected even if the subject has not received study drug treatment."},{"outcome_type":"primary","measure":"Number of participants with laboratory value abnormalities and/or AEs in Part 2","time_frame":"Up to Day 19","description":"Number of participants with potentially clinically significant laboratory values."},{"outcome_type":"primary","measure":"Number of participants with vital sign abnormalities and /or AEs in Part 2","time_frame":"Up to Day 19","description":"Number of participants with potentially clinically significant vital sign values."},{"outcome_type":"primary","measure":"Number of participants with ECG abnormalities and/or AEs in Part 2","time_frame":"Up to Day 19","description":"Number of participants with potentially clinically significant 12-ECG values."},{"outcome_type":"secondary","measure":"Part 1: Pharmacokinetics (PK) of ASP1128 in plasma: Area under the concentration-time curve (AUC) from the time of dosing extrapolated to time infinity (AUCinf)","time_frame":"Up to 72 hours post-dose on Day 1","description":"AUCinf will be recorded from the PK plasma samples collected."},{"outcome_type":"secondary","measure":"Part 1: PK of ASP1128 in plasma: AUC from the time of dosing to the last measurable concentration (AUClast)","time_frame":"Up to 72 hours post-dose on Day 1","description":"AUClast will be recorded from the PK plasma samples collected."},{"outcome_type":"secondary","measure":"Part 1: PK of ASP1128 in plasma: percentage of AUCinf due to extrapolation from time of the last measurable concentration to time infinity (AUCinf(%extrap))","time_frame":"Up to 72 hours post-dose on Day 1","description":"AUCinf(%extrap) will be recorded from the PK plasma samples collected."},{"outcome_type":"secondary","measure":"Part 1: PK of ASP1128 in plasma: maximum concentration (Cmax)","time_frame":"Up to 72 hours post-dose on Day 1","description":"Cmax will be recorded from the PK plasma samples collected."},{"outcome_type":"secondary","measure":"Part 1: PK of ASP1128 in plasma: total systemic clearance after intravenous dosing (CL)","time_frame":"Up to 72 hours post-dose on Day 1","description":"CL will be recorded from the PK plasma samples collected."},{"outcome_type":"secondary","measure":"Part 1: PK of ASP1128 in plasma: time of maximum concentration (tmax)","time_frame":"Up to 72 hours post-dose on Day 1","description":"Tmax will be recorded from the PK plasma samples collected."},{"outcome_type":"secondary","measure":"Part 1: PK of ASP1128 in plasma: terminal elimination half-life (t1/2)","time_frame":"Up to 72 hours post-dose on Day 1","description":"T1/2 will be recorded from the PK plasma samples collected."},{"outcome_type":"secondary","measure":"Part 1: PK of ASP1128 in plasma: volume of distribution during terminal elimination phase after intravenous dosing (Vz)","time_frame":"Up to 72 hours post-dose on Day 1","description":"Vz will be recorded from the PK plasma samples collected."},{"outcome_type":"secondary","measure":"Part 1: PK of ASP1128 in plasma: volume of distribution at steady state determined after intravenous dosing (Vss)","time_frame":"Up to 72 hours post-dose on Day 1","description":"Vss will be recorded from the PK plasma samples collected."},{"outcome_type":"secondary","measure":"Part 1: PK of ASP1128 in urine: cumulative amount of study drug excreted into urine from time of dosing up to the collection time of the last measurable concentration (Aelast)","time_frame":"Up to 72 hours post-dose on Day 1","description":"Aelast will be recorded from the PK urine samples collected."},{"outcome_type":"secondary","measure":"Part 1: PK of ASP1128 in urine: percentage of study drug dose excreted into urine from time of dosing up to the collection time of the last measurable concentration (Aelast%)","time_frame":"Up to 72 hours post-dose on Day 1","description":"Aelast(%) will be recorded from the PK urine samples collected."},{"outcome_type":"secondary","measure":"Part 1: PK of ASP1128 in urine: cumulative amount of study drug excreted into urine from time of dosing extrapolated to time infinity (Aeinf)","time_frame":"Up to 72 hours post-dose on Day 1","description":"Aeinf will be recorded from the PK urine samples collected."},{"outcome_type":"secondary","measure":"Part 1: PK of ASP1128 in urine: percentage of study drug dose excreted into urine from time of dosing extrapolated to time infinity (Aeinf(%))","time_frame":"Up to 72 hours post-dose on Day 1","description":"Aeinf(%) will be recorded from the PK urine samples collected."},{"outcome_type":"secondary","measure":"Part 1: PK of ASP1128 in urine: renal clearance (CLR)","time_frame":"Up to 72 hours post-dose on Day 1","description":"CLR will be recorded from the PK urine samples collected."},{"outcome_type":"secondary","measure":"Part 2 (first dose): PK of ASP1128 in plasma: AUC from the time of dosing to 24 hours (AUC24)","time_frame":"Up to 24 hours post-dose on Day 1","description":"AUC24 will be recorded from the PK plasma samples collected. This will be replaced with ACU12 in case of twice daily dosing."},{"outcome_type":"secondary","measure":"Part 2 (first dose and last dose): PK of ASP1128 in plasma: Cmax","time_frame":"Up to 24 hours post-dose on Day 1 and up to 72 hours post-dose on Day 7","description":"Cmax will be recorded from the PK plasma samples collected."},{"outcome_type":"secondary","measure":"Part 2 (first dose and last dose): PK of ASP1128 in plasma: tmax","time_frame":"Up to 24 hours post-dose on Day 1 and up to 72 hours post-dose on Day 7","description":"Tmax will be recorded from the PK plasma samples collected."},{"outcome_type":"secondary","measure":"Part 2 (last dose): PK of ASP1128 in plasma: area under the concentration time curve from the time of dosing to the start of the next dosing interval (AUCtau)","time_frame":"Up to 24 hours post-dose on Day 7","description":"AUCtau will be recorded from the PK plasma samples collected"},{"outcome_type":"secondary","measure":"Part 2 (first dose): PK of ASP1128 in plasma: AUCinf","time_frame":"Up to 24 hours post-dose on Day 1","description":"AUCinf will be recorded from the PK plasma samples collected."},{"outcome_type":"secondary","measure":"Part 2 (first and last dose): PK of ASP1128 in plasma: CL","time_frame":"Up to 24 hours post-dose on Day 1 and up to 72 hours post-dose on Day 7","description":"CL will be recorded from the PK plasma samples collected."},{"outcome_type":"secondary","measure":"Part 2 (last dose): PK of ASP1128 in plasma: peak trough ratio (PTR)","time_frame":"Up to 72 hours post-dose on Day 7","description":"PTR will be recorded from the PK plasma samples collected."},{"outcome_type":"secondary","measure":"Part 2 (last dose): PK of ASP1128 in plasma: accumulation ratio calculated using AUC (Rac(AUC))","time_frame":"Up to 24 hours post-dose on Day 1 and up to 24 hours post-dose on Day 7","description":"Rac(AUC) will be recorded from the PK plasma samples collected"},{"outcome_type":"secondary","measure":"Part 2 (first and last dose): PK of ASP1128 in plasma: t1/2","time_frame":"Up to 24 hours post-dose on Day 1 and up to 72 hours post-dose on Day 7","description":"T1/2 will be recorded from the PK plasma samples collected."},{"outcome_type":"secondary","measure":"Part 2 (first and last dose): PK of ASP1128 in plasma: Vz","time_frame":"Up to 24 hours post-dose on Day 1 and up to 72 hours post-dose on Day 7","description":"Vz will be recorded from the PK plasma samples collected."},{"outcome_type":"secondary","measure":"Part 2 (first and last dose): PK of ASP1128 in plasma: Vss","time_frame":"Up to 24 hours post-dose on Day 1 and up to 72 hours post-dose on Day 7","description":"Vss will be recorded from the PK plasma samples collected."},{"outcome_type":"secondary","measure":"Part 2 (last dose): PK of ASP1128 in urine: cumulative amount of study drug excreted into urine from the time of dosing to the start of the next dosing interval (Aetau)","time_frame":"Up to 24 hours post-dose on Day 7","description":"Aetau will be recorded from the PK urine samples collected."},{"outcome_type":"secondary","measure":"Part 2 (last dose): PK of ASP1128 in urine: percentage of study drug dose excreted into urine from the time of dosing to the start of the next dosing interval (Aetau%)","time_frame":"Up to 24 hours post-dose on Day 7","description":"Aetau% will be recorded from the PK urine samples collected."},{"outcome_type":"secondary","measure":"Part 2 (last dose): PK of ASP1128 in urine: CLR","time_frame":"Up to 24 hours post-dose on Day 7","description":"CLR will be recorded from the PK urine samples collected."},{"outcome_type":"secondary","measure":"Part 2 (Dose on days 2, 4 and 6): PK of ASP1128 in plasma: concentration immediately prior to dosing at multiple dosing (Ctrough)","time_frame":"Pre-dose on Day 2, 4 and 6","description":"Ctrough will be recorded from the PK plasma samples collected."}]}
{"nct_id":"NCT03346811","start_date":"2017-11-18","phase":"Phase 2","enrollment":120,"brief_title":"Efficiency of Icotinib in Plasma ctDNA EGFR Mutation-positive Patients Diagnosed With Lung Cancer","official_title":"Efficiency of Icotinib in Plasma ctDNA EGFR Mutation-positive Patients Diagnosed With Lung Cancera Single ArmMulti-centerOpen-label Study","primary_completion_date":"2019-05-10","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2020-03-10","last_update":"2017-11-17","description":"this single armopen-labelmulti-center study is aimed to evaluate the efficiency of icotinib in plasma ctDNA EGFR mutation-positive patients diagnosed with lung cancer","other_id":"BD-IC-IV90","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Clinical diagnosis of peripheral lung cancer, but the pathological diagnosis is not\r\n             yet clear.\r\n\r\n          -  Plasma EGFR mutations (EGFR 19del and/or 21L858R) positive (simultaneously detected by\r\n             Super-ARMS, ddPCR and NGSany positive).\r\n\r\n          -  unavailable of radical surgery or radical radiotherapy.\r\n\r\n          -  not previously received anticancer therapy like surgery, chemotherapy, radiation\r\n             therapy, and biotherapy etc.\r\n\r\n          -  Palliative radiotherapy for bone metastases is permitted, but there is no continuous\r\n             toxicity associated with radiation therapy.\r\n\r\n          -  Age 18-75 years old with performance status of 0 to 3.\r\n\r\n          -  With a measurable disease(longest diameters >=10mm with Spiral computed tomography\r\n             (CT)) according to RECIST Criteria.None of the lesions treated with radiotherapy could\r\n             be used as target lesions.\r\n\r\n          -  Adequate hematological, biochemical and organ functions.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Severe systemic disease out of control such as unstable or uncompensated\r\n             respiratory,cardiac,liver,renal diseases.\r\n\r\n          -  Evidence of interstitial lung diseases\r\n\r\n          -  Evidence of any other significant clinical disorder or laboratory finding that makes\r\n             it undesirable for the subject to participate in the study\r\n\r\n          -  Other situations researchers think not appropriate to enter the group\r\n      ","sponsor":"Betta Pharmaceuticals Co., Ltd.","sponsor_type":"Industry","conditions":"Plasma EGFR Mutation-positive Lung Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Icotinib","description":"Patients with plasma EGFR mutation-positive are arranged to receive icotinib with a dose of 125 mg three times per day, till progressive disease or unaccepted toxicity"}],"outcomes":[{"outcome_type":"primary","measure":"ORR","time_frame":"12 weeks","description":"Objective Response Rate"},{"outcome_type":"secondary","measure":"PFS","time_frame":"12 months","description":"Progression-free survival"},{"outcome_type":"secondary","measure":"DCR","time_frame":"12 months","description":"disease control rate"},{"outcome_type":"secondary","measure":"OS","time_frame":"20 months","description":"overall survival"}]}
{"nct_id":"NCT03307096","start_date":"2017-11-17","phase":"N/A","enrollment":50,"brief_title":"Evaluation of Two Different Treatments for Lower Pore Renal Stone: Microperc Vs FURS","official_title":"Evaluation of Two Different Treatments for Lower Pore Renal Stone: Microperc Vs FURS","primary_completion_date":"2019-10-01","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-12-31","last_update":"2017-11-20","description":"This is a prospect, randomized control trial to evaluate merits between microperc and FURS for lower pole renal stone","other_id":"NBDYYY2017003","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Single","intervention_model_description":"A total of 200 patients, aging between 18 and 60 years are enrolled into the study, patients will be prospectively randomized into group A and group B with a 1:1 ratio. Group A will receive the microperc surgery and group B will undergo FURS.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. 10-20mm lower pole renal stone measured by KUB or CT;\r\n\r\n          2. Age between 18-60 years, no gender limitation;\r\n\r\n          3. Participators can understand the research and sign the consent form without mental\r\n             illness nor language disorder;\r\n\r\n          4. Low pole renal stone left after lithotripsy;\r\n\r\n          5. Lower pole infundibulopelvic angle which measured by IVP or CTU will less than 30\r\n             degree;\r\n\r\n          6. Asymptomatic patients with positive urine white blood cells and negative preoperative\r\n             urine culture should be treated with antibiotics for 3days before operation;\r\n\r\n          7. Patients with symptoms of urinary infections, positive urine withe blood cells and\r\n             positive preoperative urine culture should be treated with suitable antibiotics based\r\n             on the culture sensitivity result for at least 7days before operation.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Transplant kidney stone;\r\n\r\n          2. Renal malformations, such as UPJO, medullary sponge kidney, polycystic kidney,\r\n             horseshoe kidney, etc.;\r\n\r\n          3. Combine other part of urinary stones need to be handle at the same procedure, for\r\n             example ureteral stone, renal pelvic stone, middle or upper pole renal stone;\r\n\r\n          4. Hematological Disease or Coagulation disorders;\r\n\r\n          5. Withdraw anticoagulant medicine less than two weeks;\r\n\r\n          6. Fever or urinary infections without treatment according to the inclusion criteria;\r\n\r\n          7. Sevier renal dysfunction(endogenous creatinine clearance rate50ml/min)\r\n\r\n          8. Middle or severe hydronephrosis(dilatation of the renal pelvis 20mm by ultrasound);\r\n\r\n          9. Women in menstrual period or pregnancy;\r\n\r\n         10. Patients have severe disease, such as heart disease, lung dysfunction, and multiple\r\n             organ failure that cannot tolerate anesthesia or operation.\r\n      ","sponsor":"Ningbo No. 1 Hospital","sponsor_type":"Other","conditions":"Surgery--Complications|Renal Calculus|Nephrolithiasis|Urolithiasis","interventions":[{"intervention_type":"Procedure","name":"Procedure: Microperc surgery","description":"Parents are treated by Microperc Percutaneous Nephrolithotomy"},{"intervention_type":"Procedure","name":"Procedure: FURS","description":"Parents are treated by FURS"}],"outcomes":[{"outcome_type":"primary","measure":"SFR","time_frame":"3 month","description":"Stone free Rate"},{"outcome_type":"secondary","measure":"Complications","time_frame":"3 month","description":"Complications after surgery"},{"outcome_type":"secondary","measure":"Duration of postoperative hospital stay","time_frame":"7 days","description":"Duration of postoperative hospital stay"},{"outcome_type":"secondary","measure":"Postoperative pain","time_frame":"3 month","description":"Postoperative pain,visual analogue scale(VAS)"},{"outcome_type":"secondary","measure":"The rate of hemoglobin decrease","time_frame":"7 days","description":"The rate of hemoglobin decrease"},{"outcome_type":"secondary","measure":"Operation time","time_frame":"12 hours","description":"Operation time of surgery"}]}
{"nct_id":"NCT03069664","start_date":"2017-11-17","phase":"N/A","enrollment":40,"brief_title":"Palliative Pancreatic Duct Stenting in Patients With Inoperable Pancreatic Cancer","official_title":"Palliative Pancreatic Duct Stenting in Patients With Inoperable Pancreatic Cancer","primary_completion_date":"2022-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-12-31","last_update":"2021-05-20","description":"Patients with pancreatic cancer often suffer from chronic abdominal pain, weight loss and decreased quality of life. The patients also often need pancreatic enzyme supplements. In this prospective study the aim is to see whether patients undergoing palliative pancreatic duct drainage will experience less chronic abdominal pain and a higher quality of life than patients with the same diagnosis without the procedure. The study also investigates whether the nutritional state of the patients with palliative stents remains better than in the control group.","other_id":"Palliative pancreatic stenting","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients have inoperable pancreatic cancer.\r\n\r\n          -  Pancreatic tumor causes radiologically visible dilatation of the pancreatic duct\r\n             proximally to the tumor with a minimum diameter of 6mm.\r\n\r\n          -  Patients in this study report experiencing chronic abdominal pain at least the\r\n             strength of VAS 6 (Visual Analogue Scale) at the time of recruitment.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients are not fit enough to undergo ERCP\r\n      ","sponsor":"Helsinki University Central Hospital","sponsor_type":"Other","conditions":"Pancreatic Cancer|Pancreatic Duct Stricture","interventions":[{"intervention_type":"Procedure","name":"Procedure: ERCP","description":"endoscopic retrograde cholangiopancreatography"},{"intervention_type":"Device","name":"Device: Covered Self-expandable Metal Stent","description":"Pancreatic duct stent"}],"outcomes":[{"outcome_type":"primary","measure":"Change in experienced quality of life","time_frame":"Enquiry at recruitment and every 4 weeks up to 24 weeks","description":"The patients will be asked to evaluate their quality of life with a standardized EORTC-QLQ C30 version 3 questionnaire at the time of recruitment and then every 4 weeks up to 24 weeks."},{"outcome_type":"secondary","measure":"Change in experienced strength of pain in visual analogue scale","time_frame":"Enquiry at recruitment and every 4 weeks up to 24 weeks","description":"Patients evaluate the strength of pain in visual analogue scale"},{"outcome_type":"secondary","measure":"Change in body weight","time_frame":"Enquiry at recruitment and every 4 weeks up to 24 weeks","description":"Patients report their body weight in kilograms at every point of survey."},{"outcome_type":"secondary","measure":"Change in need for pancreatic enzyme supplements","time_frame":"Enquiry at recruitment and every 4 weeks up to 24 weeks","description":"Patients report their need for pancreatic enzyme supplements at every point of survey"}]}
{"nct_id":"NCT03510728","start_date":"2017-11-15","phase":"N/A","enrollment":600,"brief_title":"Efficacy and Mechanisms of Technology-based Behavioral Interventions","official_title":"Efficacy and Mechanisms of Technology-based Behavioral Interventions","primary_completion_date":"2022-05-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-05-31","last_update":"2021-03-23","description":"Large scale surveys indicate that approximately 68% of college students drink alcohol every month and 40% of college students engage in heavy episodic drinking. Despite prevention/intervention efforts, problematic alcohol consumption among college students continues to result in an estimated 1,800 deaths and 600,000 injuries annually, and epidemiological studies demonstrate no appreciable decrease in risk among college students. The purpose of the proposed research is to improve extant college-drinking interventions by advancing the dissemination methodology and the intervention content (Specific Aim 1). As a methodological improvement, rapid advances in mobile computing makes ecological momentary interventions (EMIs) increasingly feasible. EMIs refer to interventions that can be delivered multiple times and \"in the moment\". EMIs can optimize the timing and location of the intervention while also increasing the dose of the intervention. To improve the intervention content, the researchers will examine protective behavioral strategies (PBS) to reduce alcohol problems, not just alcohol use. PBS are behaviors that one can engage in immediately prior to, during, and immediately following alcohol use that limit alcohol use and/or alcohol-related harm. Research suggests that PBS use can protect individuals from alcohol problems above and beyond its effect on reducing alcohol use. The primary purpose of this research is to provide a more powerful test of a PBS intervention's effects on alcohol-related consequences by using a technology-based intervention methodology (i.e., EMI). Participants will be randomized into to a fully crossed, 3 (Standard BMI, BMI with a PBS component, control) X 2 (PBS-based EMI, Ecological Assessment Only) design. These 6 conditions will answer several critically important research questions (Specific Aim 2): a) does the addition of a PBS component improve the efficacy of a standard BMI, b) does a PBS-based EMI improve efficacy over the standard, single session BMI, c) does the combination of motivation-based intervention (BMI) with a skills-based intervention (EMI) yield even greater decreases in consequences (i.e., moderation). A final purpose of this research is to examine PBS norms, PBS perceived effectiveness, and motivation to change PBS use as novel mediators of the improved interventions. Results can be used to disseminate more effective college drinking interventions that are cheaper and more efficacious.","other_id":"OldDominionU","allocation":"Randomized","intervention_model":"Factorial Assignment","primary_purpose":"Treatment","masking_description":"Single","intervention_model_description":"There are three conditions at the start of the study regarding assignment to a single-session intervention: none (control), standard BMI (CDCU), and the standard BMI plus a PBS-component. These are crossed with the type of application for their phone: an ecological momentary assessment-only or an ecological momentary intervention.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":25,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Current college students at the sponsor institution at the time of enrollment\r\n\r\n          -  Between the ages of 18 and 25\r\n\r\n          -  Consumed at least standard drink of alcohol in the past 4 weeks\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Under age of 18 or older than 25\r\n\r\n          -  Not a college student\r\n\r\n          -  Did not drink alcohol in the past 4 weeks\r\n      ","sponsor":"James M. Henson","sponsor_type":"Other","conditions":"College Student Drinking","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: college drinker's check up","description":"The College Drinker's Check-up (CDCU) is a single session, computer-based brief motivational intervention for heavy drinking college students. It takes a student about 45 minutes to go through it."},{"intervention_type":"Behavioral","name":"Behavioral: Protective Behavioral Strategies Intervention","description":"This intervention component focuses on educating and promoting PBS activities in future college drinking situations"},{"intervention_type":"Behavioral","name":"Behavioral: Ecological Momentary Intervention","description":"This EMI is delivered during drinking situations and focuses on promoting PBS use during that particular drinking situation."}],"outcomes":[{"outcome_type":"primary","measure":"Alcohol Consumption","time_frame":"6-months","description":"Alcohol Use Disorders Identification Test (general consumption)"},{"outcome_type":"primary","measure":"Alcohol Consumption","time_frame":"6-months","description":"Modified version of the Daily Drinking Questionnaire (typical weekly consumption)"},{"outcome_type":"secondary","measure":"Alcohol Consequences","time_frame":"6-months","description":"Young Adult Alcohol Consequences Questionnaire"},{"outcome_type":"other","measure":"Mechanisms of behavior change (PBS use)","time_frame":"6-months","description":"Revised Protective Behavioral Strategies Scale is used to measure the use of three types of protective behavioral strategies: Manner of Drinking, Limiting/Stopping Drinking, and Serious Harm Reduction. Each scale is averaged (possible range 1 - 6, 1 = not at all, 6 = always/almost always), higher scores indicate more use of protective behavioral strategies."},{"outcome_type":"other","measure":"Mechanisms of behavior change (PBS helpfulness)","time_frame":"6-months","description":"Perceived PBS Helpfulness scale assess the perceived helpfulness of using various PBS behaviors to moderate drinking. Items are assessed on a 1 (Not helpful) to 5 (Extremely helpful) scale."},{"outcome_type":"other","measure":"Mechanisms of behavior change (PBS motivation)","time_frame":"6-months","description":"The Motivation to use PBS scale assess the motivation of using various PBS behaviors to moderate drinking. Items are assessed on a 1 (Not motivated) to 5 (Extremely motivated) scale."},{"outcome_type":"other","measure":"Mechanisms of behavior change (PBS intentions)","time_frame":"6-months","description":"The Intentions to use PBS scale assess the future intentions of using various PBS behaviors to moderate drinking. Items are assessed on a 1 (Never) to 5 (Always) scale."}]}
{"nct_id":"NCT03291496","start_date":"2017-11-14","enrollment":840,"brief_title":"Microfluidic Assessment of Clinical Outcomes in Preterm Newborns","official_title":"Microfluidic Assessment of Clinical Outcomes in Preterm Newborns","primary_completion_date":"2022-05-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2022-05-31","last_update":"2021-06-24","description":"Sepsis has its greatest impact in the prematurely born (preterm) population. Neonatal sepsis (sepsis within the first month of life) causes over one million deaths worldwide annually, and is one of the most common, difficult and costly problems to diagnose, treat and prevent. The preterm infant can suffer rates of sepsis up to 1000-fold higher than the full-term infant, and bears the brunt of the associated mortality and lifelong sepsis-survivor morbidity. The project is enabled by several novel, validated, microfluidic technologies that are robust and easy to use with little training. These technologies provide comprehensive measures of the functionality of blood PMN population; a critical cellular component of innate immunity. The study team will also extract high-quality nucleic acids from microfluidic-sorted PMNs for transcriptomic analyses. Collectively, these techniques require a total of 250 microliters (L) of blood, which makes them particularly useful for preterm infants where sample volume is limited, and facilitates serial assessments with unprecedented temporal resolution of key functions of PMNs. These studies, integrated with bioinformatics approaches, will generate new tools for diagnosing sepsis in the newborn and predicting clinical outcomes. Such approaches have the capability to dramatically change the clinical management of the preterm infant, and potentially improve long-term outcomes while reducing hospital costs.","other_id":"IRB201701566 N","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":0.44231,"maximum_age":0.80769,"population":"Preterm neonates <32 weeks gestation. Term neonates >36 weeks gestation.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  For preterm neonates <32 weeks gestation at birth with no known or suspected\r\n             congenital anomalies.\r\n\r\n          -  For term neonates >36 weeks gestation at birth with no known or suspected congenital\r\n             anomalies.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Congenital defects, suspected genetic disorders, 32-36 weeks completed gestation, or\r\n             lack of consent.\r\n\r\n        Healthy Adult:\r\n\r\n          -  Inclusion criteria Between the ages of 18 and 65 years of age\r\n\r\n          -  Exclusion Criteria Taking any immune modifying medications or have an active immune\r\n             modifying disease process\r\n      ","sponsor":"University of Florida","sponsor_type":"Other","conditions":"Neonatal SEPSIS","interventions":[{"intervention_type":"Other","name":"Other: Blood Collection Preterm","description":"Blood will be collected on day 4 of life and then approximately every 3 days until 21 days of life. Thereafter, one sample will be collected weekly until discharge. For preterm neonates that have suspected sepsis an additional sample will be collected within 24-48 hours of the initial sepsis evaluation."},{"intervention_type":"Other","name":"Other: Blood Collection Term","description":"A single 250 l blood sample will be collected once the term neonate is >24 hours old."},{"intervention_type":"Other","name":"Other: Adult Blood collection","description":"One Time 1 ml of whole blood collected"}],"outcomes":[{"outcome_type":"primary","measure":"Prediction of Sepsis in Premature Neonates","time_frame":"Days 4-21","description":"The study team will determine whether blood neutrophil migration phenotype using a microfluidic-based approach can be used to predict the onset of sepsis, as well as poor outcome from sepsis, in premature neonates. From peripheral blood, the study team will measure speed, directionality, and persistence of neutrophil chemotaxis using microfluidic devices. The goal is to prospectively identify and validate biomarkers that can stratify neonates who will become septic and have a protracted clinical course. To complement these functional assays, the study team will determine if transcriptomic profiling adds to the diagnostic resolution generated through these functional analyses."},{"outcome_type":"secondary","measure":"Neutrophil Function of Premature Neonate during Development","time_frame":"Days 22-180","description":"The study team will determine whether premature neonates restore a more normal neutrophil migration phenotype and genomic profile as they reach their developmental milestones during NICU admission"}]}
{"nct_id":"NCT03194308","start_date":"2017-11-13","phase":"Phase 4","enrollment":330,"brief_title":"Safer Conception for Women - Understanding Use of Periconception PrEP","official_title":"Safer Conception for Women: PrEP Uptake/Adherence to Reduce Periconception HIV Risk for South African Women","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2021-12-31","last_update":"2020-09-29","description":"Women who choose to conceive with an infected or unknown serostatus partner in HIV-endemic settings need prevention strategies to reduce periconception HIV acquisition risk. Women at high risk for acquiring HIV during pregnancy need risk reduction strategies to protect themselves and their babies. Evaluating uptake of and adherence to antiretrovirals as pre-exposure prophylaxis in this population is crucial to understanding whether and how this novel prevention strategy should be incorporated into HIV-risk reduction packages for at- risk women planning or with pregnancy.","other_id":"2016P001535","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","intervention_model_description":"All participants are assigned to the Safer Conception study intervention.","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":35,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Female, Aged 18-35 years, Not pregnant, HIV-uninfected, Likely to be fertile based on\r\n             responses to reproductive history assessment, Not on a long-acting family planning\r\n             method, likely to have a child in the next year, either by response to modified CDC\r\n             Pregnancy Risk Assessment [2-5]), or meeting the other inclusion criteria. [If we do\r\n             not meet recruitment goals by end of May 2018, we will include women who do not meet\r\n             this criterion (5) and enroll women who meet the rest of the criteria and are\r\n             therefore at risk for pregnancy.] With a stable (>= 6 months) partner she reports as\r\n             HIV-infected or HIV-serostatus unknown, (if >1 desired pregnancy partner, we will ask\r\n             her to identify the most likely pregnancy partner- based on her own assessment of\r\n             sexual frequency, fertility, etc.), Able to participate in the informed consent\r\n             process, and Fluent in English or isiZulu\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Living at or planning to relocate to a location incompatible with study participation\r\n             in the next year, Active drug or alcohol use that, in the opinion of the research\r\n             study team, would interfere with adherence to study requirements, Active illness\r\n             requiring systemic treatment and/or hospitalization within 30 days prior to study\r\n             entry that in the opinion of the research study team, might otherwise interfere with\r\n             adherence to study requirements, Inability to adhere to the study schedule and/or\r\n             study procedures and Enrollment in studies which may conflict with their participation\r\n             in this proposed study.\r\n      ","sponsor":"Massachusetts General Hospital","sponsor_type":"Other","conditions":"HIV Prevention|Conception","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: PrEP for Safer Conception","description":"Evaluation of uptake of and adherence to PrEP and safer conception strategies including: CHCT, ART for the infected partner, and uptake of contraception for those who decide not to conceive by enrolled women, during periconception and pregnancy follow up."}],"outcomes":[{"outcome_type":"primary","measure":"Evaluation of uptake of and adherence to PrEP","time_frame":"minimum of 12 months through pregnancy outcome (maximum 21 months)","description":"The primary objective will be the evaluation of uptake of (collection of one month's supply) and adherence to PrEP (measured by quarterly plasma tenofovir levels) by women, during periconception and pregnancy follow up."},{"outcome_type":"secondary","measure":"Safer Conception Strategies","time_frame":"minimum of 12 months through pregnancy outcome (maximum 21 months)","description":"Secondary outcomes include uptake of safer conception strategies including CHCT, ART for the infected partner, uptake of contraception for those who decide not to conceive; HIV transmission events, infant outcomes, and findings from qualitative interviews to further inform the conceptual framework for periconception PrEP uptake and adherence."}]}
{"nct_id":"NCT03153384","start_date":"2017-11-11","enrollment":500,"brief_title":"Impact of the Blood Culture Technique on the Diagnosis of Infective Endocarditis","official_title":"Impact of the Blood Culture Technique on the Diagnosis of Infectious Diseases: Case of Infective Endocarditis.","primary_completion_date":"2020-11-10","study_type":"Observational [Patient Registry]","rec_status":"Unknown status","completion_date":"2021-04-30","last_update":"2020-07-17","description":"To evaluate the performance of a single high volume blood culture sampling strategy versus the actually used multiple sampling strategy for the diagnosis and categorization of infective endocarditis according to the Duke-Li classification in a Population of adults suspected of infective endocarditis.","other_id":"APJ2015/UNIENDO-GOEHRINGER/SKJ","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"Hospitalized adult patients suspected of infective endocarditis","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients older than 18 years\r\n\r\n          -  Suspected endocarditis: Patients with Duke-Li-ESC 2015 classification as a major\r\n             morphological criterion or at least two minor criteria, other than a microbiological\r\n             criterion, will be considered suspicious of infectious endocarditis.\r\n\r\n          -  Not objecting to their inclusion in the study after delivery and explanation of the\r\n             information form.\r\n\r\n          -  Absence of microbiological documentation sought or available at the time of inclusion\r\n             (a patient having already had negative blood cultures or being identified during the\r\n             screening can be included).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Antibiotherapy adapted to a situation of endocarditis, introduced more than 24 hours\r\n             or stopped for less than 7 days in case of therapeutic window.\r\n\r\n          -  Any previous antibiotic therapy in the 7 days preceding the inclusion leading to an\r\n             improvement in the clinical symptomatology.\r\n\r\n          -  State of consciousness not allowing loyal information.\r\n      ","sponsor":"Central Hospital, Nancy, France","sponsor_type":"Other","conditions":"Bacteremia|Infective Endocarditis","interventions":[{"intervention_type":"Procedure","name":"Procedure: Blood Culture","description":"For each patient, one single high volume blood culture (3 aerobic and 3 anaerobic of 8 to 10 mL each, numbered), and then 2 samples of 16 to 20 mL (one aerobic bottle and one anaerobic for each sample)."}],"outcomes":[{"outcome_type":"primary","measure":"Diagnosis of infective endocarditis: confirmed, possible or excluded","time_frame":"At the end of the hospitalization, or at the time of death if occurred during hospitalization; i.e. an average of 6 weeks after the inclusion","description":"Applying the Classification of Duke-Li according to the modified diagnostic criteria of the European Society of Cardiology Recommendations 2015."},{"outcome_type":"secondary","measure":"Diagnostic performance of the single high volume blood culture for the diagnosis of infective endocarditis","time_frame":"At the end of the hospitalization, or at the time of death if occurred during hospitalization; i.e. an average of 6 weeks after the inclusion","description":"according to the level of suspicion of infective endocarditis, the type of microorganism involved, the underlying cardiopathy."},{"outcome_type":"secondary","measure":"Measuring the nursing time required for both sampling methods.","time_frame":"At T0, i.e. at the inclusion of the patient","description":"Time for blood culture setting, processing and sending"}]}
{"nct_id":"NCT03443323","start_date":"2017-11-08","phase":"N/A","enrollment":520,"brief_title":"Organizational Skills Training","official_title":"Evaluation of Organizational Skills Training (OST) Program for Upper Elementary Students","primary_completion_date":"2022-05-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-06-30","last_update":"2021-09-10","description":"The purpose of this study is to evaluate the Organizational Skills Training Program - School based version (OST-S) in a cluster randomized trial. Participating schools will be randomly assigned to one of two groups: 1) an OST-S intervention group and 2) a treatment as usual control group. Participating students (3rd through 5th grade) will be from 20 schools in Pennsylvania and New Jersey and include both urban and suburban schools serving a diverse population. OST-S is a small-group, skills training intervention for children, which includes parent and teacher consultation to support student use of new skills. The program is delivered by school staff who receive training and consultation from intervention experts.","other_id":"17-014227","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Any student enrolled in grades 3 thru 5 in one of the participating schools who meets the\r\n        following criteria.\r\n\r\n          1. First, students will be recommended by their general education teacher if the\r\n             following are true: (a) students who are struggling the most with OTMP skills, (b)\r\n             whose OTMP skill deficits are the students' primary concern (c) whose academic\r\n             performance is negatively impacted by their OTMP deficits, and (d) who have at least\r\n             one parent who speaks English.\r\n\r\n          2. Second, students must have or be at risk for developing OTMP deficits.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Students will be excluded if they are in a pull-out special education classroom for\r\n             more than 50% of the day as the organizational demands for these students may differ\r\n             from those students placed mostly in general education.\r\n\r\n          2. Students with a one-to-one aide will be excluded because the presence of an aide\r\n             substantially alters how an organizational intervention is implemented.\r\n\r\n          3. Students from families in which both caregivers do not speak English will be excluded\r\n             because the program has not yet been developed for non-English speakers.\r\n\r\n          4. Only one student per family will be included in the study.\r\n      ","sponsor":"Children's Hospital of Philadelphia","sponsor_type":"Other","conditions":"Executive Function|Behavioral Research|Schools|Behavior Therapy","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Organizational Skills Training - School Based (OST-S)","description":"OST-S is a small group skills training intervention, with parents and teachers supporting children's use of new skills. The program manual includes strategies for training and coaching school staff, referred to as school partners, to effectively implement OST-S and guidelines to modify the program for implementation in diverse schools with diverse students. Each student session includes: (a) homework review to assess completion of between-session skills implementation; (b) skill-building activities, which include the use of modeling, shaping, guided practice, and reinforcement for organized behavior; and (c) activities to promote generalization of skills. Sessions address four organizational challenges: (a) tracking assignments, (b) managing materials, (c) managing time, and (d) planning for long term assignments."}],"outcomes":[{"outcome_type":"primary","measure":"Changes in Students' Organizational Functioning","time_frame":"Baseline, 10-weeks (post-treatment), 5-months and 12-months","description":"The Children's Organizational Skills Scales (COSS) will be used to assess changes in OTMP functioning at home and school over several time points. COSS total scores have good discriminant validity and are sensitive to treatment effects. Each COSS version uses a 4-point rating scale (1=Hardly ever or never to 4=Just about all of the time). Although the COSS yields three subscale scores, only the total score will be used to reduce the number of measures in the analyses."},{"outcome_type":"primary","measure":"Changes in students' patterns of adaptive learning","time_frame":"Baseline, 10-weeks (post-treatment), 5-months and 12-months","description":"Patterns of Adaptive Learning Scales (PALS) will be used to evaluate changes in students' perceptions of their competence in completing their classwork. Items are rated on a 5-item scale from 1 = not at all true to 5 = very true."},{"outcome_type":"secondary","measure":"Changes in Student's Academic Progress","time_frame":"Baseline, 10-weeks (post-treatment), 5-months and 12-months","description":"The Academic Progress Report (APR) is a teacher-report measure that assesses (changes in) proficiency in seven academic subjects relative to standard expectations (1=Well below standard expected at this time of year; 3=At standard; 5=Well above standard). The sum of ratings across seven academic subjects is the unit of analysis. Reliability is acceptable (alpha = .84), and this measure is sensitive to OST treatment effects."},{"outcome_type":"secondary","measure":"Changes in academic Competence of Students","time_frame":"Baseline, 10-weeks (post-treatment), 5-months and 12-months","description":"The Academic Competence Evaluation Scales (ACES) is a teacher-report scale that assesses changes in the academic competence of students in kindergarten through grade 12. The Reading/Language Arts and Math subscales of this measure will be used. Alpha coefficients and test-retest correlations for these subscales have been shown to be above .90. The average of these subscale scores will be used in the analyses."},{"outcome_type":"secondary","measure":"Academic grades of students","time_frame":"Baseline, 10-weeks (post-treatment), 5-months and 12-months","description":"Student report card grades for the marking period prior to students' participation in OST-S/TAU and for the marking period immediately after the intervention and follow-up periods. For students enrolled before the first marking period is over, baseline grades will be those obtained at the end of the previous school year."},{"outcome_type":"secondary","measure":"Completion of classwork/homework samples","time_frame":"Baseline, 10-weeks (post-treatment), 5-months and 12-months","description":"Teachers will submit copies of students' classwork and homework for a 2-week period coinciding with each assessment period (noted below in \"time frame\"). In addition, teachers will submit a list of classwork and homework assigned during each assessment period, so that it can be determined whether assignments were completed. The study team member will randomly select three classwork and homework assignments to score. The accuracy of work completed as a function of work assigned will be computed for each sample. Accuracy in completing assignments has been demonstrated to be moderately correlated (p<.01) with teacher ratings of inattention and teacher ratings of homework responsibility."},{"outcome_type":"secondary","measure":"Students' Homework Performance","time_frame":"Baseline, 10-weeks (post-treatment), 5-months and 12-months","description":"The Homework Performance Questionnaire (HPQ-T)-Teacher version will be used to assess changes in students' homework behavior during the past 4 weeks. Each item is rated on a five-point scale. The 9-item Student Self-Regulation factor will be used in the analyses. This factor has been demonstrated to have strong psychometric properties."},{"outcome_type":"secondary","measure":"Parent's report of changes in their child's homework performance","time_frame":"Baseline, 10-weeks (post-treatment), 5-months and 12-months","description":"The Homework Problem Checklist (HPC) is a 20-item parent-report measure that will be used to assess changes in student homework performance. The psychometric properties of this instrument have been shown to be acceptable, and the HPC was sensitive to treatment effects in the previous OST-C study. The total HPC score will be used in the analyses."},{"outcome_type":"secondary","measure":"Changes in Participants' views of treatment Acceptability","time_frame":"up to 10-weeks (post treatment)","description":"Measures of Acceptability of OST-S will be assessed using the following measure:\r\nThe Treatment Evaluation Inventory - Short Form (TEI-SF), a 9-item measure, will be used to assess parents' views of treatment acceptability."},{"outcome_type":"secondary","measure":"Changes in Participants' views of treatment Usability","time_frame":"up to 10-weeks (post treatment)","description":"The Usage Rating Profile-Intervention-Revised (URP-IR), a 29-item measure, will be adapted (with permission) to assess factors that may influence the usage of the OST-S intervention in a school-based setting."},{"outcome_type":"secondary","measure":"Changes in Participants' views of treatment Feasibility","time_frame":"up to 10-weeks (post treatment)","description":"The Usage Rating Profile-Intervention-Revised (URP-IR), a 29-item measure, will be adapted (with permission) to assess feasibility of usage of the OST-S intervention in a school-based setting."},{"outcome_type":"secondary","measure":"Changes in Participants' views of treatment Acceptability","time_frame":"up to 10-weeks (post treatment)","description":"The Children's Intervention Rating Profile (CIRP), a 7-item measure, will be adapted to assess student's perceptions of acceptability."}]}
{"nct_id":"NCT03072186","start_date":"2017-11-06","phase":"N/A","enrollment":23,"brief_title":"Proposal for Intraoperative Administration of Intravenous Indocyanine Green to Evaluate Position of the Optic Canal, Position of the Internal Carotid Arteries, Tumor Vascularization, and Vessel Encasement in Endoscopic Endonasal Cranial Base Surgery","official_title":"Proposal for Intraoperative Administration of Intravenous Indocyanine Green to Evaluate Position of the Optic Canal, Position of the Internal Carotid Arteries, Tumor Vascularization, and Vessel Encasement in Endoscopic Endonasal Cranial Base Surgery","primary_completion_date":"2019-01-15","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-01-24","last_update":"2021-04-26","description":"This study is being done to demonstrate the feasibility of using a nasal endoscope to perform intraoperative angiography of surgical field, with the goals to evaluate anatomical landmarks and tumor characteristics during skull base surgery and publish a technical note.","other_id":"2016H0193","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18 years and above\r\n\r\n          -  Patients undergoing an an EEA for cranial base pathology that will require any of the\r\n             following will be eligible for the study: optic canal decompression, intradural tumor\r\n             dissection, dissection of tumor around the internal carotid artery.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Less than 18 years of age\r\n\r\n          -  History of sulfa, iodide, or penicillin allergy\r\n\r\n          -  Previous anaphylactic reaction to ICG\r\n\r\n          -  Women currently pregnant or nursing\r\n      ","sponsor":"Ohio State University","sponsor_type":"Other","conditions":"Skull Base Neoplasms|Skull Neoplasms|Bone Neoplasm|Neoplasms|Bone Diseases|Musculoskeletal Disease","interventions":[{"intervention_type":"Device","name":"Device: near-infrared light nasal endoscope used with ICG","description":"Using the near-infrared light nasal endoscope with ICG will identify anatomical landmarks and and tumor characteristics to provide a clear demonstration of the blood supply."}],"outcomes":[{"outcome_type":"primary","measure":"ICG Fluorescence Ratio","time_frame":"Before intradural dissection and during tumor dissection.","description":"We aim to show that ICG fluorescence of the tumor intraoperatively is directly proportional to the contrast enhancement of the tumor from preoperative MRI. Enhancement is shown in ratio form on a scale of 0.01-1.00 showing enhancement ratios of 1. gland to internal carotid artery compared to blood fluorescence and 2. tumor tissue to blood fluorescence. Video recordings of intra-operative ICG fluorescence was compared to pre-operative imaging enhancements and compared in ratio format with a possible score of 0.01-1.00 The higher the ratio, the more closely the intra-operative fluorescence was related to the pre-operative imaging enhancements. 1.00 is considered to have the same enhancing brightness on pre-operative imaging as intra-operative video surveillance."}]}
{"nct_id":"NCT03371303","start_date":"2017-11-01","enrollment":400,"brief_title":"Analysis of Changes in Medication Prescriptions After Hospitalization for 4 Disciplines: Gerontology, Diabetology, Cardiology and Rheumatology: Medical, Pharmaceutical and Economic Aspects","official_title":"Analysis of Changes in Medication Prescriptions After Hospitalization for 4 Disciplines: Gerontology, Diabetology, Cardiology and Rheumatology: Medical, Pharmaceutical and Economic Aspects","primary_completion_date":"2020-02-29","study_type":"Observational [Patient Registry]","rec_status":"Unknown status","completion_date":"2021-02-28","last_update":"2017-12-13","description":"The modifications of the medicinal treatments secondary to the hospitalizations have multiple reasons: reassessment of the previous treatment (conciliation), new therapeutic necessities, potential risk of iatrogeny or of drug interaction, restrictions of the therapeutic booklet, classification in reserve or hospital prescription ... These modifications are potentially generating extra costs for the Health Insurance and are monitored under the terms of the Contract of Good Use. The aims of this analysis are to define the medical-pharmaceutical rationale of the treatment changes imposed by hospitalization in a university-hospital center, their influence on the security of the medical treatment of patients and their financial implications for healthcare organizations","other_id":"2016-25","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","population":"Patients must be hospitalized in one of the services of a university hospital, in the\r\n        following 4 disciplines: diabetology, geriatrics, cardiology and rheumatology","criteria":"\n        inclusion criteria\r\n\r\n          -  Patient social insured\r\n\r\n          -  Patient belonging to the general social security scheme\r\n\r\n          -  Patient followed in cardiology, rheumatology, geriatrics or diabetology departments\r\n\r\n        no exclusion criteria\r\n      ","sponsor":"Assistance Publique Hopitaux De Marseille","sponsor_type":"Other","conditions":"Diabetes|Cardiac Disease|Rheumatic Diseases","interventions":[{"intervention_type":"Other","name":"Other: collection of prescription data","description":"collection of prescription data before and after a hospitalization"}],"outcomes":[{"outcome_type":"primary","measure":"exit orders after hospitalization","time_frame":"15 months"},{"outcome_type":"primary","measure":"entry orders before hospitalization","time_frame":"15 months"}]}
{"nct_id":"NCT03081910","start_date":"2017-11-01","phase":"Phase 1","enrollment":42,"brief_title":"Autologous T-Cells Expressing a Second Generation CAR for Treatment of T-Cell Malignancies Expressing CD5 Antigen","official_title":"Phase 1 Therapy With Manufactured Autologous T-Cells Expressing a Second Generation Chimeric Antigen Receptor (CAR) for Treatment of T-Cell Malignancies Expressing CD5 Antigen","primary_completion_date":"2024-01-15","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2039-09-01","last_update":"2021-02-21","description":"Patients eligible for this study have a type of blood cancer called T-cell leukemia or lymphoma (lymph gland cancer). The body has different ways of fighting infection and disease. No one way seems perfect for fighting cancers. This research study combines two different ways of fighting disease, antibodies and T cells, hoping that they will work together. Antibodies are types of proteins that protect the body from bacterial and other diseases. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells including tumor cells. Both antibodies and T cells have been used to treat patients with cancers; they have shown promise, but have not been strong enough to cure most patients. T lymphocytes can kill tumor cells but there normally are not enough of them to kill all the tumor cells. Some researchers have taken T cells from a person's blood, grown more of them in the laboratory and then given them back to the person. In some patients who have recently had a bone marrow or stem cell transplant, the number of T cells in their blood may not be enough to grow in the laboratory. In this situation, T cells may be collected from their previous transplant donor, who has a similar tissue type. The antibody used in this study is called anti-CD5. It first came from mice that have developed immunity to human leukemia. This antibody sticks to T-cell leukemia or lymphoma cells because of a substance on the outside of these cells called CD5. CD5 antibodies have been used to treat people with T-cell leukemia and lymphoma. For this study, anti-CD5 has been changed so that instead of floating free in the blood it is now joined to the T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor. In the laboratory, the investigators have also found that T cells work better if proteins that stimulate T cells are also added, such as one called CD28. Adding the CD28 makes the cells grow better and last longer in the body, thus giving the cells a better chance of killing the leukemia or lymphoma cells. In this study investigators are going to attach the CD5 chimeric receptor with CD28 added to it to the patient's T cells or the previous bone marrow transplant donor's T cells. The investigators will then test how long the cells last. The decision to use the bone marrow transplant donor's T cells instead of the patient's will be based on 1) whether there is an available and willing donor and 2) the likelihood of the patient's T cells being able to grow in the lab. These CD5 chimeric receptor T cells with CD28 are investigational products not approved by the Food and Drug Administration.","other_id":"H-40466, MAGENTA","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","maximum_age":75,"population":"","criteria":"\n        Procurement Inclusion Criteria\r\n\r\n        Referred patients will initially be consented for procurement of blood for generation of\r\n        the transduced ATL. Eligibility criteria at this stage include:\r\n\r\n          1. Diagnosis of recurrent T-cell acute lymphoblastic leukemia (T-ALL), T-cell acute\r\n             lymphoblastic lymphoma (T-LLy), or T-non-Hodgkin lymphoma (T-NHL, including\r\n             Angioimmunoblastic T-cell lymphoma (AITL), Enteropathy-associated T-cell lymphoma\r\n             (EATL), Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL), Peripheral\r\n             T-cell lymphoma (PTCL) NOS, Anaplastic large cell lymphoma (ALCL), Adult T-cell\r\n             leukemia/lymphoma, T cell prolymphocytic leukemia with symptomatic disease, Extranodal\r\n             NK/T cell lymphoma, Mycosis fungoides/ Sezary Syndrome Stage IIB or higher)\r\n\r\n             AND\r\n\r\n             Group A: Transplant nave and suitable for allogeneic hematopoietic stem cell\r\n             transplant (HSCT) with confirmation of an identified eligible allo-HSCT donor by FACT\r\n             accredited institution\r\n\r\n             OR\r\n\r\n             Group B: Relapsed post-allogeneic HSCT with previous HSCT donor from whom allogeneic\r\n             MAGENTA CAR T cells can be manufactured\r\n\r\n             AND with confirmation that the center plans to proceed with transplant if CD5.CAR\r\n             treatment induces a complete remission.\r\n\r\n          2. CD5-positive tumor (result can be pending at this time). > 50% CD5 + blasts by flow\r\n             cytometry or immunohistochemistry (tissue) assessed by a CLIA certified Flow\r\n             Cytometry/Pathology laboratory.\r\n\r\n          3. Age less than or equal to 75 years old. NOTE: The first six (6) patients treated on\r\n             the study will be adults (>18 yrs of age). Six adolescents (age 12-18) will be treated\r\n             before children (>3 yrs of age) are eligible.\r\n\r\n          4. Hgb greater than or equal to 7.0 (can be transfused)\r\n\r\n          5. Life expectancy greater than 12 weeks\r\n\r\n          6. If pheresis required to collect blood:\r\n\r\n               -  Creatinine <1.5  upper limit normal\r\n\r\n               -  AST <1.5  upper limit normal\r\n\r\n               -  PT and APTT <1.5  upper limit normal\r\n\r\n          7. Informed consent explained to, understood by and signed by patient/guardian.\r\n             Patient/guardian given copy of informed consent.\r\n\r\n        Procurement Exclusion Criteria:\r\n\r\n          1. Active infection requiring antibiotics.\r\n\r\n          2. Active infection with HIV.\r\n\r\n          3. Clinically significant viral infection or uncontrolled viral reactivation of EBV, CMV,\r\n             Adv, BK-virus, or HHV-6.\r\n\r\n          4. Cardiac criteria: Atrial fibrillation/flutter; Myocardial infarction within the last\r\n             12 months; Prolonged QT syndrome or secondary prolonged QT, per investigator\r\n             discretion. Cardiac echocardiography with LVSF less than or equal to 30% or LVEF less\r\n             than or equal to 50% or clinically significant pericardial effusion; Cardiac\r\n             dysfunction NYHA III or IV (Confirmation of absence of these conditions within 12\r\n             months of treatment).\r\n\r\n          5. History of other cancer (except non-melanoma skin cancer or in situ breast cancer or\r\n             cervix cancer) unless the tumor was successfully treated with curative intent at least\r\n             2 years before trial entry.\r\n\r\n        Treatment Inclusion Criteria:\r\n\r\n          1. Diagnosis of recurrent T-cell acute lymphoblastic leukemia (T-ALL), T-cell acute\r\n             lymphoblastic lymphoma (T-LLy), or T-non-Hodgkin lymphoma (T-NHL, including\r\n             Angioimmunoblastic T-cell lymphoma (AITL), Enteropathy-associated T-cell lymphoma\r\n             (EATL), Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL), Peripheral\r\n             T-cell lymphoma (PTCL) NOS, Anaplastic large cell lymphoma (ALCL), Adult T-cell\r\n             leukemia/lymphoma, T cell prolymphocytic leukemia with symptomatic disease, Extranodal\r\n             NK/T cell lymphoma, Mycosis fungoides/ Sezary Syndrome Stage IIB or higher)\r\n\r\n             AND Group A: Transplant nave and suitable for allogeneic hematopoietic stem cell\r\n             transplant (HSCT) with confirmation of an identified eligible allo-HSCT donor by FACT\r\n             accredited institution\r\n\r\n             OR\r\n\r\n             Group B: Relapsed post-allogeneic HSCT with previous HSCT donor from whom allogeneic\r\n             MAGENTA CAR T cells can be manufactured.\r\n\r\n             AND with confirmation that the center plans to proceed with transplant if CD5.CAR\r\n             treatment induces a complete remission.\r\n\r\n          2. CD5-positive tumor: >50% CD5+ blasts by flow cytometry or immunohistochemistry\r\n             (tissue) assessed in a CLIA certified Flow Cytometry/Pathology laboratory.\r\n\r\n          3. Age less than or equal to 75 years old. NOTE: The first six (6) patients treated on\r\n             the study will be adults (>18 yrs of age). Six adolescents (age 12-18) will be treated\r\n             before children (>3 yrs of age) are eligible.\r\n\r\n          4. Bilirubin less than 3 times the upper limit of normal.\r\n\r\n          5. AST less than 5 times the upper limit of normal.\r\n\r\n          6. Estimated GFR > 60 mL/min.\r\n\r\n          7. Pulse oximetry of > 90% on room air\r\n\r\n          8. Karnofsky or Lansky score of greater than or equal to 60%.\r\n\r\n          9. Recovered from acute toxic effects of prior chemotherapy at least one week before\r\n             entering this study.\r\n\r\n         10.  60 days post-allogeneic HSCT at time of treatment.\r\n\r\n         11. Life expectancy of greater than 12 weeks.\r\n\r\n         12. Sexually active patients must be willing to utilize one of the more effective birth\r\n             control methods during the study and for 6 months after the study is concluded. The\r\n             male partner should use a condom.\r\n\r\n         13. Informed consent explained to, understood by, and signed by patient/guardian.\r\n             Patient/guardian given copy of informed consent.\r\n\r\n        Treatment Exclusion Criteria:\r\n\r\n          1. Currently receiving any investigational agents or having received any tumor vaccines\r\n             within the previous 6 weeks.\r\n\r\n          2. History of hypersensitivity reactions to murine protein-containing products.\r\n\r\n          3. Pregnant or lactating.\r\n\r\n          4. Tumor in a location where enlargement could cause airway obstruction.\r\n\r\n          5. Active infection with HIV.\r\n\r\n          6. Clinically significant viral infection or uncontrolled viral reactivation of EBV, CMV,\r\n             Adv, BK-virus, or HHV-6.\r\n\r\n          7. Evidence of acute GVHD > Grade II or active chronic GVHD > mild global severity score\r\n\r\n          8. Currently taking corticosteroids for therapy of GVHD at a dose of >0.5mg/kg prednisone\r\n             equivalent\r\n\r\n          9. Patients who have received Immunosuppressive Treatment (IST) for GVHD within 28 days\r\n             of infusion\r\n\r\n         10. Patients who have received donor lymphocyte infusion (DLI) within 28 days of infusion\r\n\r\n         11. Cardiac criteria: Prolonged QT syndrome; Atrial fibrillation/flutter; Myocardial\r\n             infarction within the last 12 months; Cardiac echocardiography with LVSF less than or\r\n             equal to 30% or LVEF less than or equal to 50%; Cardiac dysfunction NYHA III or IV;\r\n             Cardiac echocardiography with clinically significant pericardial effusion.\r\n\r\n         12. CNS abnormalities: Presence of CNS-3 disease defined as detectable cerebrospinal blast\r\n             cells in a sample of CSF with greater than or equal to 5 WBCs per mm3; History or\r\n             presence of any CNS disorder such as a seizure disorder, cerebrovascular\r\n             ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS\r\n             involvement.\r\n      ","sponsor":"Baylor College of Medicine","sponsor_type":"Other","conditions":"T-cell Acute Lymphoblastic Lymphoma|T-non-Hodgkin Lymphoma|T-cell Acute Lymphoblastic Leukemia","interventions":[{"intervention_type":"Genetic","name":"Genetic: Autologous CD5.CAR/28zeta CAR T cells","description":"Three dose levels will be evaluated:\r\nDose level one: 110^7 cells/m2\r\nDose level two: 510^7 cells/m2\r\nDose level three: 110^8 cells/m2\r\nThe first six (6) patients treated on the study will be adults (>18 yrs of age). Six adolescents (age 12-18) will be treated before children (>3 yrs of age) are eligible.\r\nThe T cells will be administered with Cytoxan and fludarabine."},{"intervention_type":"Drug","name":"Drug: Fludarabine","description":"Patients will receive 3 daily doses of fludarabine (30 mg/m2) to induce lymphopenia, finishing at least 24 hours before T cell infusion. Infusions should be given following hospital/pharmacy recommendations (including dose adjustments as appropriate per institutional guidelines) however at a minimum the fludarabine should be infused over 30 minutes. Mesna, IV hydration and anti-emetics should also be provided following local institutional guidelines."},{"intervention_type":"Drug","name":"Drug: Cytoxan","description":"Patients will receive 3 daily doses of cyclophosphamide (500 mg/m2/day) to induce lymphopenia, finishing at least 24 hours before T cell infusion. Infusions should be given following hospital/pharmacy recommendations (including dose adjustments as appropriate per institutional guidelines) however at a minimum the cyclophosphamide should be infused over 1 hour. Mesna, IV hydration and anti-emetics should also be provided following local institutional guidelines."},{"intervention_type":"Genetic","name":"Genetic: Allogeneic CD5.CAR/28zeta CAR T cells","description":"Three dose levels will be evaluated:\r\nDose level one: 110^7 cells/m2\r\nDose level two: 510^7 cells/m2\r\nDose level three: 110^8 cells/m2\r\nThe first six (6) patients treated on the study will be adults (>18 yrs of age). Six adolescents (age 12-18) will be treated before children (>3 yrs of age) are eligible.\r\nThe T cells will be administered with Cytoxan and fludarabine."}],"outcomes":[{"outcome_type":"primary","measure":"Dose limiting toxicity (DLT) rate","time_frame":"6 weeks post-infusion","description":"Defined as the proportion of subjects in each group with DLT evaluated as per the CTCAE 4.0 with the exception of Cytokine Release Syndrome (CRS) and neurological toxicities that are related to T cell infusions."},{"outcome_type":"secondary","measure":"Overall Response Rate","time_frame":"4 weeks pre-infusion and 6 weeks post-infusion","description":"Overall response rate is calculated as the proportion of subjects with the best overall response according to a revised response criteria for malignant lymphoma or bone marrow analyses for leukemia. Evaluations of tumor size will be performed within 4 weeks of beginning treatment and 6-8 weeks after T cell infusion (earlier if clinically indicated)."}]}
{"nct_id":"NCT03457584","start_date":"2017-11-01","phase":"N/A","enrollment":96,"brief_title":"Effect of Air-tamponade on Intraretinal Cystoid Changes After Membrane Peeling","official_title":"Effect of Air-tamponade on Intraretinal Cystoid Changes After Vitrectomy With Membrane Peeling","primary_completion_date":"2019-12-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-12-01","last_update":"2020-09-29","description":"Patients with intraretinal cystoid changes before scheduled membrane peeling for epiretinal membranes are included. Patients are randomized for balanced salt solution (BSS) or air-tamponade.","other_id":"cysMP","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  epiretinal membranes and intraretinal cystoid changes\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  macular edema due to other reason than epiretinal membrane\r\n\r\n          -  hereditary ocular disease\r\n\r\n          -  pregnancy\r\n      ","sponsor":"Vienna Institute for Research in Ocular Surgery","sponsor_type":"Other","conditions":"Epiretinal Membrane","interventions":[{"intervention_type":"Procedure","name":"Procedure: air arm","description":"epiretinal membranes are excised during membrane peeling and air-tamponade is left in the eye"},{"intervention_type":"Procedure","name":"Procedure: BSS arm","description":"epiretinal membranes are excised during membrane Peeling and BSS is left in the eye"}],"outcomes":[{"outcome_type":"primary","measure":"resorption of intraretinal cystoid changes after surgery","time_frame":"3 months","description":"occurrence of intraretinal cystoid changes will be diagnosed by OCT"}]}
{"nct_id":"NCT03157934","start_date":"2017-10-26","enrollment":12000,"brief_title":"Schlaganfallkonsortium Rhein-Neckar (Stroke Consortium Rhine-Neckar)","official_title":"Schlaganfallkonsortium Rhein-Neckar (Stroke Consortium Rhine-Neckar)","primary_completion_date":"2021-12-31","study_type":"Observational [Patient Registry]","rec_status":"Recruiting","completion_date":"2022-03-31","last_update":"2020-11-05","description":"FAST is an investigator-initiated multicenter study embedded in a German multistate acute stroke network. The main objectives of the FAST study are to improve outcomes and quality of care for stroke patients, to quantify the number of patients in need of thrombectomy within an integrated stroke network, to study the best way of delivering and performing thrombectomy and to investigate the best model of pre-hospital selection and referral for stroke patients.","other_id":"FAST","observational_model":"Other","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Acute stroke patients admitted to one of the hospitals of the Stroke Consortium\r\n        Rhein-Neckar (FAST)","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18 years or older\r\n\r\n          -  Patients with ischemic stroke who are admitted to one of the hospitals of the Stroke\r\n             Consortium Rhein-Neckar (FAST)\r\n\r\n          -  informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  no informed consent\r\n      ","sponsor":"University Hospital Heidelberg","sponsor_type":"Other","conditions":"Ischemic Stroke|Vascular Diseases|Cardiovascular Diseases","interventions":[{"intervention_type":"Other","name":"Other: not applicable (observational study)","description":"Observational study without study related intervention"}],"outcomes":[{"outcome_type":"primary","measure":"Functional outcome","time_frame":"3 months after intevention","description":"Functional outcome according to the modified Rankin Scale (mRS)"},{"outcome_type":"secondary","measure":"Number of patients receiving acute recanalisation therapies of all referrals","time_frame":"24 h after stroke onset","description":"Number of patients receiving thrombolysis and/or thrombectomy of all patients included in to the Network via the database."},{"outcome_type":"secondary","measure":"Referral rates","time_frame":"Stroke onset to discharge from acute hospital; through study completion, an average of 2 years","description":"Referral rates by stroke service level (i.e. type of treatment center)"}]}
{"nct_id":"NCT03439644","start_date":"2017-10-25","phase":"N/A","enrollment":280,"brief_title":"Physiological Upper Eyelid Laxity","official_title":"Physiological Upper Eyelid Laxity","primary_completion_date":"2017-11-27","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-11-27","last_update":"2018-02-20","description":"This is a prospective, single-center study in normal subjects aged 20 to 89 years. The objective was to describe upper eyelid laxity by age group (20/29 years old, 30/39 years old, 40/49 years old, 50/59 years old, 60/69 years old, 70/79 years old and 80/89 years old) measured with the method of McNab and studying it according to her customary side of sleep. In addition, we evaluated a method for measuring tarsal laxity.","other_id":"LAX","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Screening","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":89,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  20 to 89 years\r\n\r\n          -  be free\r\n\r\n          -  be able to give informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of facial paralysis, upper palpebral trauma or palpebral surgery\r\n\r\n          -  History of sleep apnea syndrome\r\n\r\n          -  Impossibility to give consent\r\n\r\n          -  Pregnant or lactating women\r\n\r\n          -  Persons enjoying enhanced protection and persons deprived of their liberty by a\r\n             judicial or administrative decision\r\n      ","sponsor":"Poitiers University Hospital","sponsor_type":"Other","conditions":"Eyelid Laxity","interventions":[{"intervention_type":"Other","name":"Other: Measurement of the upper eyelid laxity","description":"Measurement using a soft slider of the distance between our 2 marks The difference obtained between the measurement and the initial 10 millimeters corresponds to the tarsal laxity."}],"outcomes":[{"outcome_type":"primary","measure":"Evolution of upper eyelid laxity","time_frame":"10 minutes","description":"Comparison of upper right and left palpebral laxity values in millimeters between different age groups"}]}
{"nct_id":"NCT03319641","start_date":"2017-10-25","phase":"N/A","enrollment":25,"brief_title":"PSMA-PET Imaging for Advanced ACC/SDC","official_title":"68Ga-PSMA-PET/CT Imaging for Locally Advanced, Recurrent and Metastatic Adenoid Cystic Carcinoma or Salivary Duct Carcinoma","primary_completion_date":"2018-05-14","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-05-14","last_update":"2018-05-30","description":"Diagnostic study which evaluates the level of PSMA expression in patients with locally advanced, recurrent and/or metastatic ACC/SDC of 18 years old with 68Ga-PSMA-PET/CT imaging in order to establish whether these patients are eligible for 177Lu-PSMA therapy","other_id":"104902","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","intervention_model_description":"diagnostic study","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  locally advanced, recurrent or metastatic ACC/SDC\r\n\r\n          -  Age  18 years old\r\n\r\n          -  Ability to provide written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Contra-indication for PET imaging\r\n\r\n          -  Pregnancy\r\n\r\n          -  Breast feeding\r\n\r\n          -  Severe claustrophobia\r\n\r\n          -  Impaired renal function: MDRD <30 ml/min/1,73 m2\r\n\r\n          -  Impaired liver function: AST and ALT  2.5 x ULN (5 x ULN for patients with liver\r\n             metastases)\r\n      ","sponsor":"Radboud University","sponsor_type":"Other","conditions":"Salivary Gland Cancer|Adenoid Cystic Carcinoma|Salivary Duct Carcinoma","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: PSMA-PET/CT scan","description":"perform a PSMA-PET/CT scan in patients with locally advanced, recurrent and/or metastastic ACC or SDC"}],"outcomes":[{"outcome_type":"primary","measure":"uptake of 68Ga-PSMA in ACC and SDC","time_frame":"0 days","description":"To evaluate the uptake of 68Ga-PSMA in locally advanced, recurrent and metastatic ACC/SDC by performing 68Ga-PSMA-PET/CT scans"},{"outcome_type":"secondary","measure":"SUV of 68Ga-PSMA in ACC/SDC tumors","time_frame":"0 days","description":"SUV of 68Ga-PSMA in ACC/SDC tumors"},{"outcome_type":"secondary","measure":"SUV of 68Ga-PSMA in the background","time_frame":"0 days","description":"in order to calculate the SUV tumor to background ratio"},{"outcome_type":"secondary","measure":"correlation of SUV and IHC PSMA-staining","time_frame":"0 days","description":"Correlate the tumor uptake (SUV) to the degree of immunohistochemical PSMA expression of the primary tumor on archival tissue"},{"outcome_type":"secondary","measure":"new metastases","time_frame":"0 days","description":"To establish whether new metastatic lesions are found by 68GA-PSMA-PET/CT imaging"}]}
{"nct_id":"NCT03288779","start_date":"2017-10-24","phase":"N/A","enrollment":6,"brief_title":"Theta Burst Stimulation for Schizophrenia","official_title":"Theta Burst Stimulation for Schizophrenia","primary_completion_date":"2018-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-06-30","last_update":"2019-11-25","description":"Purpose and objective Schizophrenia is a chronic debilitating illness with cognitive deficits that cause serious impairment in psychosocial recovery and with few treatments to remediate these deficits. One area that holds great promise for the development of novel, effective therapies is noninvasive brain stimulation. The investigators have used one form of brain stimulation, transcranial magnetic stimulation (TMS), for some time to modulate and enhance cognitive function in the brain, especially working memory (WM) function, which has a central role in most executive processing that occurs in the brain. Theta burst stimulation (TBS) is a paradigm of TMS which has been shown to effectively modulate WM. Moreover, TBS can modulate gamma neural oscillations in the brain and neural activity, both of which have been implicated in the physiology of WM and pathophysiology of the disease process in schizophrenia, making these measures highly valuable for assessing physiological effects of TBS on cognition, quality of life and cortical inhibition. The purpose of this study is to evaluate the effect of TBS on WM in patients with schizophrenia, to develop evidence for potential brain stimulation techniques to treat cognitive deficits in schizophrenia. Study activities and population group: Study subjects will be inpatient schizophrenic individuals with minimal positive symptoms and predominant cognitive deficits at Duke University Hospital. In an initial session they will be screened and taught a WM task. Following this, one TBS session will follow in which TBS will target dorsolateral prefrontal cortex. They will perform the WM task before, with and after the TBS, with an expected pre-post enhancement of WM performance. Implications - There is a great need for treatments for cognitive deficits in schizophrenia. The results of this study will serve to generate pilot data for a much larger grant to develop a TBS therapy for remediating such cognitive deficits.","other_id":"Pro00083070","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients aged 18-65 years of age with schizophrenia or schizoaffective disorder\r\n\r\n          -  No other mental health diagnoses\r\n\r\n          -  Right handed males and females\r\n\r\n          -  May have mild positive symptoms (score of <\/= 21)\r\n\r\n          -  May have negative symptoms\r\n\r\n          -  Ability to provide informed consent\r\n\r\n          -  No restriction on concomitant medications given\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Intellectual disability\r\n\r\n          -  Any organic brain illness Presence of dementia symptoms or traumatic brain injury\r\n             Primary diagnosis of substance use Seizure disorder Actively symptomatic with PANSS\r\n             positive symptom sub-scale >21. Concurrently receiving electroconvulsive therapy (ECT)\r\n      ","sponsor":"Duke University","sponsor_type":"Other","conditions":"Schizophrenia|Schizoaffective Disorder","interventions":[{"intervention_type":"Device","name":"Device: Theta Burst Stimulation","description":"Transcranial magnetic stimulation with theta burst stimulation"}],"outcomes":[{"outcome_type":"primary","measure":"Brief Assessment of Cognition (BACS) Composite T Score","time_frame":"30 minutes","description":"Performance on tasks included in the Brief Assessment of Cognition in Schizophrenia (BACS) battery, task performed and results recorded on IPAD. The mean change from baseline in total cognitive score on the BACS was calculated as a weighted average of T-scores (normalized for age) from BACS subtests including Verbal Memory, Digit Sequencing, Token Motor, Symbol Coding, Semantic Fluency, Letter Fluency, and Tower of London. The minimum and maximum values possible for this composite T-score of the change from baseline were -131 and 131, respectively. Higher values (positive changes from baseline) indicate better performance."},{"outcome_type":"secondary","measure":"Change in Gamma and Theta Oscillations as Measured by EEG","time_frame":"one session, approximately 30 minutes"}]}
{"nct_id":"NCT03310489","start_date":"2017-10-24","phase":"N/A","enrollment":420,"brief_title":"A Randomized Controlled Study of Digitalized Cognitive-behavioral Intervention for Childhood Anxiety","official_title":"Digitalized Cognitive-behavioral Intervention for Anxiety Among School Children. A Randomized Controlled Study","primary_completion_date":"2020-12-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2020-12-31","last_update":"2020-09-10","description":"The aim of the study is to evaluate the effectiveness of a digitalized cognitive-behavioral treatment for anxiety among school aged children. The participants are screened from the general population, as a part of the routine school health care check-ups. Half of the children with anxiety will receive the digitalized treatment program, while the other half will receive education about anxiety in internet.","other_id":"ANXIETY-2017","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        - Scoring 22 on SCARED\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  no access to internet\r\n\r\n          -  insufficient language (Finnish until summer 2019, Finnish and Swedish from autumn 2019\r\n             onwards, when also Swedish version of the intervention was available) skills\r\n\r\n          -  visual or hearing impairment that hinders the use of the program\r\n\r\n          -  the child's mental retardation, autism spectrum disorder, suicidal intentions or\r\n             severe mental disorder\r\n\r\n          -  the child's psychotherapy (ongoing or starting within 6 months)\r\n\r\n          -  the child's medication (for anxiety) started / changed within 2 months\r\n\r\n          -  current involvement with child protection services (i.e., removal of child custody,\r\n             investigation of child abuse or neglect)\r\n\r\n          -  parent's severe psychiatric / somatic disease or other reason that hinders the parent\r\n             to actively participate in the program\r\n      ","sponsor":"University of Turku","sponsor_type":"Other","conditions":"Anxiety","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Digitalized cognitive-behavioral intervention for anxiety","description":"An internet-based CBT, including telephone coaching"},{"intervention_type":"Behavioral","name":"Behavioral: Psychoeducation about anxiety","description":"Psychoeducative material about anxiety in internet"}],"outcomes":[{"outcome_type":"primary","measure":"Change from Baseline to 6 months follow up; the Screen for Child Anxiety Related Disorders - child and parent reports","time_frame":"Change from baseline to 6 months follow up; symptoms during the last three months","description":"Comprises of 41 items assessing symptoms of general anxiety, separation anxiety, panic disorder, social anxiety, and school phobia; scoring 0-82 (higher score meaning more symptoms)"},{"outcome_type":"secondary","measure":"Change from Baseline to 6 months follow up; the Child Anxiety Impact Scale - child and parent reports","time_frame":"Change from baseline to 6 months follow up; impact of anxiety during the last month","description":"Comprises of 27 items assessing the impact of anxiety on the daily life of the children at home, school and with friends; scoring 0-81 (higher score meaning higher impact of anxiety)"},{"outcome_type":"secondary","measure":"Change from Baseline to 6 months follow up (in the Intervention group); the Development and Well-Being Assessment - child and parent reports","time_frame":"Change from baseline to 6 months follow up; varying time windows for different diagnoses","description":"A diagnostic interview to assess anxiety disorders among 2-17-year-old children"},{"outcome_type":"secondary","measure":"Change from Baseline to 6 months follow up; the Revised Children Quality of Life - Questionnaire - child and parent reports","time_frame":"Change from baseline to 6 months follow up; QoL during the last week","description":"Comprises of 24 items assessing the health-related quality of life divided into six subscales: physical, psychological, self-esteem, family, social life, and school; scoring 24-96 (higher score meaning higher QoL)"},{"outcome_type":"secondary","measure":"Change from Baseline to 6 months follow up; the Child Depression inventory - child report","time_frame":"Change from baseline to 6 months follow up; symptoms during the last two weeks","description":"Comprises of 28 items assessing the child's depressive symptoms; scoring 0-54 (higher score meaning more symptoms)"},{"outcome_type":"secondary","measure":"Change from Baseline to 6 months follow up; the Strengths and Difficulties Questionnaire, extended version - parent report","time_frame":"Change from baseline to 6 months follow up; symptoms during the last six months","description":"Comprises of 25 items assessing the child's psychiatric symptoms and positive attributes, and an impact supplement; scoring 0-40 (prosocial scale is not included in the total score) (higher score meaning more problems)"},{"outcome_type":"secondary","measure":"Change from Baseline to 6 months follow up of the relations with peers and school (not a standardized scale)","time_frame":"Change from baseline to 6 months follow up","description":"Experience of being bullied (traditional and cyberbullying), and feelings about school and teachers"},{"outcome_type":"secondary","measure":"Change from Baseline to 6 months follow up; the Brief resilience scale - parent report (parental resilience)","time_frame":"Change from baseline to 6 months follow up; experience of the current resilience","description":"Comprises of six items assessing resilience; scoring 6-36 (higher score meaning higher resilience)"},{"outcome_type":"secondary","measure":"Change from Baseline to 6 months follow up; the Depression Anxiety and Stress Scale Short Form - parent report (parental depression, anxiety and stress)","time_frame":"Change from baseline to 6 months follow up; symptoms during the last week","description":"Comprises of 21 items assessing parental depression, anxiety and stress; scoring 0-63 (higher score meaning more symptoms)"},{"outcome_type":"secondary","measure":"Change from Baseline to 6 months follow up; the Customised Client Receipt Inventory Questionnaire - parent report","time_frame":"Change from baseline to 6 months follow up; service use during the last six months","description":"Assesses the child's use of school support services, and social and health care services"}]}
{"nct_id":"NCT03086278","start_date":"2017-10-20","phase":"Phase 1","enrollment":16,"brief_title":"A Study of AST-008 in Healthy Subjects","official_title":"A Randomized, Combined SAD/MAD Phase 1 Study of the Safety, Pharmacokinetics and Pharmacodynamics of AST 008 in Healthy Subjects","primary_completion_date":"2018-08-16","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-08-16","last_update":"2018-09-25","description":"AST-008 will be dosed subcutaneously to healthy volunteers in a combined SAD/MAD study to evaluate its safety, tolerability, pharmacokinetics and pharmacodynamics.","other_id":"AST-008-101","intervention_model":"Sequential Assignment","primary_purpose":"Screening","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":40,"population":"","criteria":"\n        Main Inclusion Criteria:\r\n\r\n          1. Healthy male or female subjects aged 18 and 40 years of age at the time of first\r\n             dosing.\r\n\r\n          2. Subjects must have a body mass index (BMI) between 18.0-25.0 kg/m inclusive.\r\n\r\n          3. Satisfactory medical assessment with no clinically significant or relevant\r\n             abnormalities as determined by medical history, physical examination, vital signs,\r\n             12-lead ECG, and clinical laboratory evaluation (haematology, biochemistry,\r\n             coagulation, and urinalysis) that is reasonably likely to interfere with the subject's\r\n             participation in or ability to complete the study as assessed by the Investigator.\r\n\r\n          4. Ability to provide written, personally signed, and dated informed consent to\r\n             participate in the study, in accordance with the ICH Good Clinical Practice (GCP)\r\n             Guideline E6 (1996) and applicable regulations, before completing any study-related\r\n             procedures.\r\n\r\n          5. An understanding, ability, and willingness to fully comply with study procedures and\r\n             restrictions.\r\n\r\n        Main Exclusion Criteria:\r\n\r\n          1. Current or recurrent disease (e.g., cardiovascular, haematological, neurological,\r\n             endocrine, renal, liver, GI or other conditions) that could affect the action,\r\n             absorption, or disposition of AST-008, or could affect clinical assessments or\r\n             clinical laboratory evaluations.\r\n\r\n          2. Any history of cancer.\r\n\r\n          3. Any history (including significant and confirmed family history) of autoimmune or\r\n             antibody-mediated diseases including but not limited to: systemic lupus erythematosus,\r\n             rheumatoid arthritis, multiple sclerosis, autoimmune hepatitis, or thrombocytopenia.\r\n\r\n          4. Has had an acute illness within two weeks prior to screening.\r\n\r\n          5. Current or relevant history of physical or psychiatric illness that may require\r\n             treatment or make the subject unlikely to fully comply with the requirements of the\r\n             study or complete the study, or any condition that presents undue risk from the\r\n             investigational product or study procedures.\r\n\r\n          6. Any other significant disease or disorder which, in the opinion of the investigator,\r\n             may either put the subject at risk because of participation in the study may influence\r\n             the result of the study, or the subject's ability to participate in the study.\r\n\r\n          7. Female subjects who are pregnant or breastfeeding.\r\n\r\n          8. Subjects with abnormal findings of inguinal, axillary, or cervical lymph nodes at\r\n             screening or Day -1.\r\n\r\n          9. A positive human immunodeficiency virus (HIV) antibody screen, hepatitis B surface\r\n             antigen (HBsAg), or hepatitis C virus (HCV) antibody screen.\r\n\r\n         10. Titres above reference ranges (according to local laboratory) for autoimmune\r\n             antibodies: rheumatoid factor (RF), anti-nuclear antibodies (ANA), anti-neutrophil\r\n             cytoplasmic antibodies (ANCA).\r\n      ","sponsor":"Exicure, Inc.","sponsor_type":"Industry","conditions":"Healthy Volunteer Study","interventions":[{"intervention_type":"Drug","name":"Drug: AST-008","description":"AST-008 is a toll-like receptor 9 agonist."}],"outcomes":[{"outcome_type":"primary","measure":"Serious related adverse events","time_frame":"Up to 1 month after the last dose of AST-008","description":"To evaluate SAEs after a single subcutaneous dose of AST-008"},{"outcome_type":"primary","measure":"Adverse events","time_frame":"Up to 1 month after the last dose of AST-008","description":"To evaluate adverse events after a single subcutaneous dose of AST-008"},{"outcome_type":"secondary","measure":"Dose finding","time_frame":"Up to 1 month after the last dose of AST-008","description":"To recommend a dose and regimen for further development."},{"outcome_type":"secondary","measure":"Maximum plasma concentration assessment","time_frame":"Up to 1 month after the last dose of AST-008","description":"Measurement of the maximum observed plasma concentration (Cmax) after single doses of AST-008"},{"outcome_type":"secondary","measure":"AUC assessment","time_frame":"Up to 1 month after the last dose of AST-008","description":"Measurement of the area under the curve (AUC) after single doses of AST-008"},{"outcome_type":"secondary","measure":"Pharmacodynamics","time_frame":"Up to 1 month after the last dose of AST-008","description":"Measurement of type 1 cytokine concentrations as a function of time after single doses of AST-008"},{"outcome_type":"secondary","measure":"Pharmacodynamics","time_frame":"Up to 1 month after the last dose of AST-008","description":"Measurement of changes in absolute number and and fraction of a panel of lymphocyte markers as a function of time after single doses of AST-008"},{"outcome_type":"secondary","measure":"QTc interval testing","time_frame":"Up to 1 month after the last dose of AST-008","description":"To determine the effect of AST-008 on QTc interval"}]}
{"nct_id":"NCT03229538","start_date":"2017-10-18","phase":"Phase 3","enrollment":1200,"brief_title":"STeroids to REduce Systemic Inflammation After Infant Heart Surgery","official_title":"STeroids to REduce Systemic Inflammation After Infant Heart Surgery (STRESS)","primary_completion_date":"2022-01-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-03-31","last_update":"2021-07-27","description":"This study's objective is to determine the pharmacokinetics (PK)/pharmacodynamics (PD), safety and efficacy of methylprednisolone in infants undergoing heart surgery with cardiopulmonary bypass. This is a prospective, double blind, multi-center, placebo-controlled safety and efficacy study. Blood samples will be collected from a subset of enrolled study participants to evaluate multiple dose methylprednisolone PK/PD. Participants will be randomized in a 1:1 fashion to intravenous methylprednisolone versus placebo. Study drug/placebo will be administered 8 to 12 hours before the anticipated start time of surgery and in the operating room at the time of initiation of cardiopulmonary bypass. Patients will be followed for primary and secondary outcomes for the duration of their hospitalization. Serious study drug-related adverse events will be collected for 7 days after the last dose of study drug.","other_id":"Pro00078106","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","maximum_age":1,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age < 1 year at the time of surgery\r\n\r\n          -  Undergoing heart surgery with CPB as part of standard clinical care\r\n\r\n          -  Availability and willingness of the parent/legally authorized representative to\r\n             provide written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  < 37 weeks adjusted gestational age at time of surgery\r\n\r\n          -  Any oral or intravenous steroid treatment within two days of surgery\r\n\r\n          -  Any patient receiving any of the following medications within 2 days of surgery:\r\n\r\n        Amphoteracin B, aminoglutethimide, anticholesterases, warfarin, P450 3A4 inducers including\r\n        (but not limited to) carbamazepine, phenobarbital, phenytoin, rifampin, bosentan and\r\n        nafcillin or P450 3A4 inhibitors including (but not limited to) clarithromycin,\r\n        voriconazole, itraconazole, ketoconazole, ciprofloxacin, diltiazem, fluconazole,\r\n        erythromycin and verapamil.\r\n\r\n          -  Infection contraindicating steroid use\r\n\r\n          -  Preoperative mechanical circulatory support or active resuscitation at the time of\r\n             randomization\r\n\r\n          -  Emergent surgery precluding steroid administration 8-12 hours before surgery\r\n      ","sponsor":"Kevin Hill","sponsor_type":"Other","conditions":"Congenital Heart Disease in Children|Inflammatory Response","interventions":[{"intervention_type":"Drug","name":"Drug: Methylprednisolone","description":"IV Steroid pre-operative and intra-operative"},{"intervention_type":"Drug","name":"Drug: Isotonic saline","description":"Isotonic saline pre-operative and intra-operative"}],"outcomes":[{"outcome_type":"primary","measure":"A composite mortality, major morbidity and length of stay global rank endpoint with endpoints ranked according to severity.","time_frame":"Until hospital discharge. Length of stay up to 6 months","description":"A composite mortality, major morbidity and length of stay global rank endpoint with endpoints ranked according to severity.\r\nFor this endpoint each randomized patient will be assigned a rank based upon their most-severe outcome."},{"outcome_type":"secondary","measure":"Mortality including in-hospital mortality or mortality after hospital discharge but within 30 days of the last cardiac operation of the admission","time_frame":"up to 30 days"},{"outcome_type":"secondary","measure":"Death or major complication as previously defined and reported by the STS-CHSD registry.","time_frame":"Until hospital discharge. Length of stay up to 6 months"},{"outcome_type":"secondary","measure":"Post-operative hospital length of stay","time_frame":"Until hospital discharge. Length of stay up to 6 months"},{"outcome_type":"secondary","measure":"Prevalence of prolonged (>7days) mechanical ventilation","time_frame":"Until hospital discharge. Length of stay up to 6 months"},{"outcome_type":"secondary","measure":"Occurrence of post-operative low cardiac output syndrome. Based upon the STS-CHSD registry defined \"cardiac dysfunction resulting in low cardiac output\" complication variable","time_frame":"Until hospital discharge. Length of stay up to 6 months"},{"outcome_type":"secondary","measure":"Occurence of any one or more of the following STS-CHSD-defined major post-operative infectious complications: o Postprocedural infective endocarditis o Pneumonia o Sepsis o Deep wound infection o Mediastinitis","time_frame":"Until hospital discharge. Length of stay up to 6 months"},{"outcome_type":"secondary","measure":"Any other post-operative complications from the start of study drug administration until hospital discharge.","time_frame":"Until hospital discharge. Length of stay up to 6 months"},{"outcome_type":"secondary","measure":"PK/PD - Time to maximum concentration (Tmax)","time_frame":"Pre-2nd dose and minimum of 2 of any of the following 5 time points (0-30 minutes after the start of CPB, 0-30 minutes after MUF, 1-2 hours after completion of CPB, 4-6 hours after completion of CPB, or 16-24 hours after completion of CPB)"},{"outcome_type":"secondary","measure":"PK/PD - Maximum concentration (Cmax)","time_frame":"Pre-2nd dose and minimum of 2 of any of the following 5 time points (0-30 minutes after the start of CPB, 0-30 minutes after MUF, 1-2 hours after completion of CPB, 4-6 hours after completion of CPB, or 16-24 hours after completion of CPB)"},{"outcome_type":"secondary","measure":"PK/PD - Clearance (CL)","time_frame":"Pre-2nd dose and minimum of 2 of any of the following 5 time points (0-30 minutes after the start of CPB, 0-30 minutes after MUF, 1-2 hours after completion of CPB, 4-6 hours after completion of CPB, or 16-24 hours after completion of CPB)"},{"outcome_type":"secondary","measure":"PK/PD - Volume of distribution (Vd)","time_frame":"Pre-2nd dose and minimum of 2 of any of the following 5 time points (0-30 minutes after the start of CPB, 0-30 minutes after MUF, 1-2 hours after completion of CPB, 4-6 hours after completion of CPB, or 16-24 hours after completion of CPB)"},{"outcome_type":"secondary","measure":"Post-operative biomarkers of the inflammatory response to cardiopulmonary bypass including interleukins 6 and 8","time_frame":"Pre-2nd dose; a minimum of 2 of any of the following 5 time points (0-30 min after the start of CPB, 0-30 min after MUF, 1-2 hrs after CPB end, 4-6 hrs after CPB end, or 16-24 hrs after CPB end); and 36-48 hrs after CPB end","description":"Only to be collected at select centers and in those patients whose parent/legally authorized representative have granted consent to blood draws"}]}
{"nct_id":"NCT03600987","start_date":"2017-10-18","phase":"N/A","enrollment":4,"brief_title":"Effect of Music on Reading Comprehension in Patients With Aphasia","official_title":"Effect of Music on Reading Comprehension in Patients With Aphasia","primary_completion_date":"2019-10-17","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-10-17","last_update":"2020-01-06","description":"The purpose of this investigation is to examine the evidence on emotion, language, and music, and propose a first step, in the form of a single-subject research design, to determine the most effective and efficient method for application to the rehabilitation of patients with aphasia. A single-subject adapted alternating treatment design will be used to compare two music conditions, using music with sung lyrics simultaneously with reading of the lyrics, and priming with music and sung lyrics followed by a reading of the lyrics, with a control condition using reading lyrics without music. Results are expected to provide evidence of independent versus shared processing of music and language at the phrase level applied to the behavior of human subjects with aphasia.","other_id":"IRB #2408","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Single-subject adapted alternating treatment design.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Post-hospitalization;\r\n\r\n          -  premorbid reading at the 8th grade level or higher based on the participant's/family's\r\n             stated years of formal education;\r\n\r\n          -  post-stroke aphasia/left middle cerebral artery (MCA) cerebral vascular accident (CVA)\r\n             based on electronic medical record (EMR) and computed tomography (CT) and/or magnetic\r\n             resonance imaging (MRI) imaging reports, or consult with the neurologist;\r\n\r\n          -  intact left amygdala and left extrastriate cortex based on EMR and CT/MRI imaging\r\n             reports, or consult with the neurologist;\r\n\r\n          -  reliability in answering yes-no questions as determined by an 80% score on therapy\r\n             tasks during regular speech therapy;\r\n\r\n          -  capacity to provide informed consent concerning a study involving an intervention with\r\n             music therapy determined by the physician who refers the patient.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Co-morbidities diagnosed and reported in the EMR or shown on CT scan or MRI including\r\n             past history of stroke in other brain regions with residual symptoms, dementia,\r\n             Parkinson disease, head injury, etc.;\r\n\r\n          -  hemianopsia or other visual field defects affecting vision for reading, and in\r\n             particular right homonymous hemi- or inferior quadrantanopsia;\r\n\r\n          -  previous history of learning disabilities in reading/writing;\r\n\r\n          -  significant psychiatric diagnosis;\r\n\r\n          -  English as a Second Language or non-English language.\r\n      ","sponsor":"Carilion Clinic","sponsor_type":"Other","conditions":"Aphasia","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Simultaneous music and reading lyrics","description":"listening to music with singing of the lyrics simultaneously with reading the written lyrics."},{"intervention_type":"Behavioral","name":"Behavioral: Priming with music","description":"priming by listening to music and singing of the lyrics followed by reading the written lyrics."},{"intervention_type":"Behavioral","name":"Behavioral: Control","description":"control condition using reading materials without music."}],"outcomes":[{"outcome_type":"primary","measure":"Percent correct responses per day on phrase completion task.","time_frame":"through study completion, an average of 1 year.","description":"Differential response to the interventions (counted as the percent correct responses per day)."},{"outcome_type":"primary","measure":"Number of sessions required to achieve mastery.","time_frame":"through study completion, an average of 1 year.","description":"Count number of sessions."},{"outcome_type":"primary","measure":"Retention of the reading material.","time_frame":"3 weeks post-intervention.","description":"Number of items recalled."},{"outcome_type":"secondary","measure":"International Classification of Functioning, Disability, and Health (ICF) body Functions/Structures, Activities, and Participation.","time_frame":"through study completion, an average of 1 year.","description":"Pretest-posttest information on the ICF Body Functions/Structures, Activities, and Participation (Hurkmans et al., 2011)."},{"outcome_type":"secondary","measure":"Boston Diagnostic Aphasia Examination-Third Edition (BDAE-3) (Goodglass, Harold, & Barresi, Austin: PRO-Ed.).","time_frame":"through study completion, an average of 1 year.","description":"BDAE-3 pretest-posttest reading scores on subtests: Word Identification/Word-Picture Match and Lexical Decision; Homophone Matching; Derivational and Grammatical Morphology/Matching to spoken sample; Oral Reading/Basic oral word reading; Oral Reading of Sentences with Comprehension; and Reading Comprehension-Sentences and Paragraphs. Pretest will be completed prior to baseline and initiating intervention, and posttest with be completed immediately following completion of intervention to assess generalization to non-trained stimuli."}]}
{"nct_id":"NCT03322449","start_date":"2017-10-13","phase":"N/A","enrollment":37,"brief_title":"APOA2 Gene, Diet, Inflammation and Gut Health","official_title":"APOA2 Gene, Diet, Inflammation and Gut Health","primary_completion_date":"2020-04-30","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2021-12-31","last_update":"2021-04-19","description":"Nutrients and chemicals in food are able to regulate expression of genetic elements. Gene-nutrient interaction in response to unhealthy diets can increase an individual's risk, shifting the individual from health toward the development of chronic disease. The apolipoprotein A2 (APOA2) gene may either put individuals at risk for or protect from obesity in the presence of certain fats in food. The main purpose of this four-week study is to examine diet induced gene-nutrient interaction, with a focus on gut health, gut microbiota and inflammation in individuals who have either the CC or the TT form within a specific variant of the APOA2 Gene. The (2) one-week study diets, one plant based and the other animal based are separated by a (1) week return to your regular habitual without probiotic or prebiotic food products.","other_id":"2016-08911","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Prevention","masking_description":"Single","intervention_model_description":"randomized crossover dietary intervention","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Men and women\r\n\r\n          -  18 years or older\r\n\r\n          -  Women who are not pregnant\r\n\r\n          -  A BMI ranging between 27 and 34\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Unexplained elevation in serum transaminases (i.e. >1.5 times the upper limit of\r\n             normal) or with evidence of active liver disease, including primary biliary cirrhosis\r\n             or pre-existing gallbladder disease\r\n\r\n          -  Severe renal dysfunction (serum creatinine >2.0mg/dL)\r\n\r\n          -  Excessive alcohol consumption (>2 drinks/day)\r\n\r\n          -  Preexisting cardiovascular disease (CVD)\r\n\r\n          -  Stable exertional angina pectoris requiring sublingual nitroglycerin within the prior\r\n             3 months\r\n\r\n          -  Uncontrolled tyoe 2 diabetes (T2D) (fasting glucose >126 mg/dl) or other significant\r\n             endocrine disease.\r\n\r\n          -  Uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood\r\n             pressure >100 mmHg).\r\n\r\n          -  History of pancreatitis within 1 yr. prior to screening.\r\n\r\n          -  Subjects on lipid lowering or diabetes medications.\r\n\r\n          -  Smoking\r\n\r\n          -  Pregnancy\r\n\r\n          -  Body mass index (BMI) below 27 or greater than 34 kg/m2\r\n\r\n          -  Participants will also be excluded for drug abuse, extreme dietary habits, multiple\r\n             food allergies, extreme levels of physical or athletic activity, or by changes in body\r\n             weight >20 lbs. during the last 6 months\r\n\r\n          -  Current use of antibiotics or during the previous 4 weeks.\r\n\r\n          -  Inability to follow any of the experimental diets (including being vegetarian) or to\r\n             perform the sampling required for this study\r\n\r\n          -  Use of herbal supplements that may alter the gut microflora\r\n\r\n          -  Autoimmune diseases\r\n\r\n          -  Recent colonoscopy (within the previous two months)\r\n\r\n          -  Use of antidiarrheal medication\r\n\r\n          -  Thyroid diseases\r\n\r\n          -  Use of omega-3 supplements (unless it is discontinued one month prior to the beginning\r\n             of the study).\r\n      ","sponsor":"Tufts University","sponsor_type":"Other","conditions":"Inflammation","interventions":[{"intervention_type":"Other","name":"Other: Animal Diet","description":"during one week participants will receive food products enriched in animal products and with high content of fat and protein"},{"intervention_type":"Other","name":"Other: Plant Diet","description":"during one week participants will receive plant products enriched in fiber and complex carbohydrates"}],"outcomes":[{"outcome_type":"primary","measure":"tryptophan metabolism","time_frame":"1 week per intervention arm","description":"The response of plasma metabolites related to tryptophan metabolism to diets differing in saturated fat and prebiotics content (animal-based diet versus plant-based diet) will vary in individuals carrying CC (n=20) and TT (n=20) genotypes at the common APOA2 -265T>C single nucleotide polymorphism (SNP)"},{"outcome_type":"secondary","measure":"Satiety assessment using plasma levels of leptin","time_frame":"1 week per intervention arm","description":"Plasma leptin (ng/ml) will be measured in plasma during each one of the intervention phases. The response of leptin (ng/ml) to a saturated fat rich diet will be less on subjects with the CC genotype at the APOA2 locus as compared to TT subjects"},{"outcome_type":"secondary","measure":"adipose tissue metabolism","time_frame":"1 week per intervention arm","description":"Plasma adiponectin (micrograms/ml) will be measured in plasma during each one of the intervention phases. The response of adiponectin to a saturated fat rich diet will be less on subjects with the CC genotype at the APOA2 locus as compared to TT subjects"},{"outcome_type":"secondary","measure":"Plasma Lipoproteins","time_frame":"1 week per intervention arm","description":"Plasma lipoprotein concentrations in mg/dl (VLDL, LDL, HDL) and subclasses assessed by proton nuclear magnetic resonance (NMR) spectroscopy"},{"outcome_type":"secondary","measure":"Gut microbiota diversity and composition","time_frame":"1 week per intervention arm","description":"A low saturated fat (SFA)/high prebiotic (plant-based) diet and a high SFA/low prebiotic (animal-based) diets have a differential effect on gut microbiota patterns according to the presence of the CC or TT genotypes at the APOA2-265T>C variant"},{"outcome_type":"secondary","measure":"Plasma levels of Interleukin 6 to assess inflammatory status","time_frame":"1 week per intervention arm","description":"Plasma Levels of interleukin-6 (IL6) (pg/ml) will be measured during each of the dietary phases. IL6 will be higher in CC subjects at the APOA2 locus when consuming a high fat diet than when consuming a low fat diet. A low fat diet will not elicit increased IL6 levels in TT APOA2 subjects."},{"outcome_type":"secondary","measure":"Plasma levels of tumor necrosis factor alpha to assess regulation of immune cells","time_frame":"1 week per intervention arm","description":"Plasma Levels of tumor necrosis factor alpha (TNFA)(pg/ml) measured during each diet phase, will be significantly different depending on diet and APOA2 genotype. TNFA will be higher in CC subjects at the APOA2 locus when consuming a high fat diet than when consuming a low fat diet. A low fat diet will not elicit increased TNFA levels in TT APOA2 subjects."},{"outcome_type":"secondary","measure":"Plasma levels of C-reactive to assess regulation of inflammation","time_frame":"1 week per intervention arm","description":"Plasma Levels of C-reactive protein (CRP) (mg/L) measured during each diet phase will be significantly different depending on diet and APOA2 genotype. CRP will be higher in CC subjects at the APOA2 locus when consuming a high fat diet than when consuming a low fat diet. A low fat diet will not elicit increased CRP levels in TT APOA2 subjects."},{"outcome_type":"secondary","measure":"Plasma levels of Lipopolysaccharides to assess gut inflammation","time_frame":"1 week per intervention arm","description":"Plasma Levels of lipopolysaccharides (LPS) (ng/ml) will be significantly different depending on diet and APOA2 genotype. LPS will be higher in CC subjects at the APOA2 locus when consuming a high fat diet than when consuming a low fat diet. A low fat diet will not elicit increased LPS levels in TT APOA2 subjects."}]}
{"nct_id":"NCT03305770","start_date":"2017-10-12","phase":"N/A","enrollment":107,"brief_title":"DD T2 Daily Disposable Registration Trial","official_title":"DD T2 Daily Disposable Registration Trial","primary_completion_date":"2018-02-21","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-02-21","last_update":"2019-02-22","description":"The purpose of this study is to evaluate the performance of the investigational verofilcon A contact lens compared to the commercially available delefilcon A contact lens, by assessing visual acuity as the primary variable.","other_id":"CLE383-C005","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Successful wear of spherical soft contact lenses for distance correction in both eyes\r\n             during the past 3 months for a minimum of 5 days per week and 8 hours per day.\r\n\r\n          -  Best corrected VA 20/25 or better in each eye.\r\n\r\n          -  Other protocol-specified inclusion criteria may apply.\r\n\r\n        Exclusion Criteria\r\n\r\n          -  Any current or prior wear experience with DT1 lenses.\r\n\r\n          -  Wearing habitual contact lenses in an extended wear modality (routinely sleeping in\r\n             lenses for at least 1 night per week) over the last 3 months prior to enrollment.\r\n\r\n          -  Other protocol-specified exclusion criteria may apply.\r\n      ","sponsor":"Alcon Research","sponsor_type":"Industry","conditions":"Myopia|Refractive Errors","interventions":[{"intervention_type":"Device","name":"Device: verofilcon A contact lenses","description":"Daily disposable soft contact lenses"},{"intervention_type":"Device","name":"Device: delefilcon A contact lenses","description":"Daily disposable soft contact lenses"}],"outcomes":[{"outcome_type":"primary","measure":"Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)","time_frame":"Dispense, Week 1, Week 2, Month 1, Month 2, Month 3","description":"VA was assessed for each eye individually using a Snellen chart at a distance of 4 meters. A 20/20 Snellen acuity is considered normal distance eyesight. No formal hypotheses were formulated; hence no inferential testing was performed."}]}
{"nct_id":"NCT03320265","start_date":"2017-10-11","phase":"Phase 2","enrollment":10,"brief_title":"Phosphorylcholine PC-mAb Effects in Subjects With Elevated Lipoprotein a","official_title":"Double-blind, Randomised, Placebo-controlled, Multicentre, Phase IIa Study to Investigate the Effect of PC-mAb on Arterial Inflammation in Subjects With Elevated Lipoprotein a","primary_completion_date":"2018-03-19","study_type":"Interventional","rec_status":"Terminated","completion_date":"2018-07-03","last_update":"2018-07-06","description":"Inflammation and abnormal amount of lipids in the blood are key factors for the development and progression of atherosclerosis (thickening of the artery wall) and cardiovascular disease. Lipoprotein (a) is a pro-inflammatory plasma lipoprotein that is believed to be a risk factor for cardiovascular diseases. Vascular inflammation generates a range of effects, including endothelial dysfunction and migration of white blood cells into the vessel wall, which results in increased risk of cardiovascular events. This study is designed to assess the effects of multiple monthly intravenous infusions with the fully human antibody called PC-mAb, in subjects with elevated lipoprotein (a).","other_id":"ATH3G10-005","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":50,"population":"","criteria":"\n        Major inclusion criterion:\r\n\r\n          -  Lp(a) above 50 mg/dL at screening\r\n\r\n        Major exclusion criteria:\r\n\r\n          -  Medical history of myocardial infarction (MI) or stroke within 12 months of screening\r\n\r\n          -  Ongoing or paroxysmal atrial fibrillation\r\n\r\n          -  Clinically overt heart failure\r\n\r\n          -  Hypertension defined as 180/100 mmHg\r\n\r\n          -  Diabetes mellitus\r\n\r\n          -  Systemic autoimmune diseases requiring treatment\r\n\r\n          -  Cancer, excluding basal cell carcinoma, within the last five years\r\n      ","sponsor":"Athera Biotechnologies AB","sponsor_type":"Industry","conditions":"Arterial Inflammation|Cardiovascular Diseases","interventions":[{"intervention_type":"Drug","name":"Drug: PC-mAb","description":"Monthly treatment for 3 months (4 administrations)"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Monthly treatment for 3 months (4 administrations)"}],"outcomes":[{"outcome_type":"primary","measure":"Monocyte function","time_frame":"From baseline (Day 1) to visit 11 (Day 85)","description":"Change in transendothelial migration (TEM) in monocytes isolated from treated subjects"},{"outcome_type":"secondary","measure":"Arterial inflammation","time_frame":"From baseline (Day 1) to visit 11 (Day 85)","description":"Change in tissue to background ratio (TBRmax) in common carotid arteries by fluorodeoxyglucose-positron emission tomography/computed tomography (FDG-PET/CT)"},{"outcome_type":"secondary","measure":"Arterial stiffness","time_frame":"From baseline (Day 1) to visit 11 (Day 85)","description":"Change in pulse wave velocity (PWV) (m/sec)"},{"outcome_type":"secondary","measure":"Adverse events (AEs)/serious AEs (SAEs)","time_frame":"From baseline (Day 1) to visit 11 (Day 85)","description":"Incidence of AEs/SAEs"},{"outcome_type":"secondary","measure":"Vital signs, height","time_frame":"At screening (Day -63 to -1)","description":"in cm"},{"outcome_type":"secondary","measure":"Vital signs, body weight","time_frame":"At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)","description":"in kg"},{"outcome_type":"secondary","measure":"Vital signs, blood pressure","time_frame":"At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)","description":"in mmHg"},{"outcome_type":"secondary","measure":"Vital signs, hear rate","time_frame":"At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)","description":"in bpm"},{"outcome_type":"secondary","measure":"Vital signs, body temperature","time_frame":"At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)","description":"in °C"},{"outcome_type":"secondary","measure":"Physical examination including review of all organ systems","time_frame":"At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)","description":"Any abnormalities will be recorded"},{"outcome_type":"secondary","measure":"Electrocardiogram (ECG), PR (PQ)","time_frame":"At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)","description":"12-lead ECG; PR (PQ) interval (in msec) will be measured and reported descriptively; any abnormalities will be recorded"},{"outcome_type":"secondary","measure":"ECG, QRS","time_frame":"At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)","description":"12-lead ECG; QRS interval (in msec) will be measured and reported descriptively; any abnormalities will be recorded"},{"outcome_type":"secondary","measure":"ECG, QT","time_frame":"At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)","description":"12-lead ECG; QT interval (in msec) will be measured and reported descriptively; any abnormalities will be recorded"},{"outcome_type":"secondary","measure":"ECG, QTcF","time_frame":"At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)","description":"12-lead ECG; QTcF interval (in msec) will be measured and reported descriptively; any abnormalities will be recorded"}]}
{"nct_id":"NCT03148171","start_date":"2017-10-09","phase":"N/A","enrollment":290,"brief_title":"Project WERK (Wellness Encouragement Respect Kinship)","official_title":"Project WERK (Wellness Encouragement Respect Kinship): Network Support to Engage and Retain Younger Black MSM in PrEP Care","primary_completion_date":"2021-01-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2021-11-30","last_update":"2020-11-04","description":"The Project WERK intervention is a brief, theory based and culturally sensitive intervention designed to capitalize on organic yet underutilized social support networks in the lives of young black men who have sex with men (YBMSM). The intervention has been developed with input from clients and their support network members, case managers, social workers, primary care providers. The goal of the intervention is to improve retention in PrEP care for young Black MSM.","other_id":"IRB17-0152","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":35,"population":"","criteria":"\n        Inclusion criteria\r\n\r\n        Index subjects:\r\n\r\n          -  Self-identify as African American/Black;\r\n\r\n          -  Assigned male sex at birth;\r\n\r\n          -  Any same gender anal or oral sex in the past 2 years;\r\n\r\n          -  English speaking;\r\n\r\n          -  Have at least one support contact in their network;\r\n\r\n          -  Own a cell phone not shared with other persons;\r\n\r\n          -  Between the ages of 18-35 years old; and\r\n\r\n          -  Have had fewer than 3 PrEP clinical visits in the past 12 months.\r\n\r\n        Support Contact:\r\n\r\n          -  Index participant has agreed to including the support contact\r\n\r\n          -  Willing to attend face to face and telephone mini-booster sessions;\r\n\r\n          -  18 years of age or older;\r\n\r\n          -  English speaking; and\r\n\r\n          -  Owns a cell phone that is not shared with other persons.\r\n\r\n        Exclusion Criteria\r\n\r\n        Index Subject:\r\n\r\n          -  Unable to provide informed consent;\r\n\r\n          -  Plan to move out of the area within the next 12 months;\r\n\r\n          -  Are not willing to attend intervention sessions; or\r\n\r\n          -  Not willing to return for assessments.\r\n\r\n        For index participants without a support contact, we will refer them to an appropriate\r\n        support group for PrEP.\r\n\r\n        Support Contact:\r\n\r\n          -  Romantic partner of index participant;\r\n\r\n          -  Unable to provide informed consent;\r\n\r\n          -  Plan to move out of the area within the next 12 months;\r\n\r\n          -  Are not willing to attend intervention sessions; or\r\n\r\n          -  Not willing to return for assessments.\r\n      ","sponsor":"University of Chicago","sponsor_type":"Other","conditions":"HIV Prevention","interventions":[{"intervention_type":"Other","name":"Other: WERK Supportive Contact","description":"Provide emotional support and practical support. Support friend/family by helping him to stay engaged in PrEP Care."}],"outcomes":[{"outcome_type":"primary","measure":"Retention in PrEP Care","time_frame":"12-month","description":"Completing scheduled PrEP visits as determined by Electronic Medical Record (EMR) data"},{"outcome_type":"secondary","measure":"HIV testing and STI testing","time_frame":"12 months","description":"HIV serostatus and STI testing as determined by EMR data"},{"outcome_type":"secondary","measure":"Closeness and social support","time_frame":"12 months","description":"Closeness and social support measures based on self-report"}]}
{"nct_id":"NCT03159429","start_date":"2017-10-05","phase":"N/A","enrollment":19,"brief_title":"Nasal Ventilation Versus Voluntary Hypoventilation in the Rehabilitation of Hyperventilation Syndrome","official_title":"Nasal Ventilation Versus Voluntary Hypoventilation in the Rehabilitation of Hyperventilation Syndrome: a Randomized, Controlled Trial","primary_completion_date":"2020-01-15","study_type":"Interventional","rec_status":"Terminated","completion_date":"2020-01-15","last_update":"2020-04-10","description":"The main objective of this study is to measure the effect (at 3 months) of dyspnea control rehabilitation with nasal ventilation versus standard rehabilitation, in dyspneic patients with hyperventilation syndrome.","other_id":"9796","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"The included population will be randomized into two parallel groups. One group will be assigned the experimental intervention. The other group will be assigned standard care. Outcomes will be compared between the two randomized groups.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  The patient must have given his / her free and informed consent and signed the consent\r\n\r\n          -  The patient must be a member or beneficiary of a health insurance program\r\n\r\n          -  The patient is available for 3 months of follow-up\r\n\r\n          -  The patient has at least two of the following clinical symptoms consistent with\r\n             hyperventilation sydrome: dyspnea, chest pain or pressure, visual blurring, dizziness,\r\n             a sensation of abdominal swelling, tingling in the fingers, stiffness in the fingers\r\n             or arms, tingling sensation around the mouth, cold or moist hands, tension or anxiety\r\n\r\n          -  Resting hypocapnia defined by a PaCO2 <38 mmHg and a normal O2 alveolo-arterial\r\n             gradient D (A-a) O2\r\n\r\n          -  Absence of significant obstructive or restrictive pathology according to respiratory\r\n             function tests\r\n\r\n          -  Absence of indirect signs of pulmonary arterial hypertension according to\r\n             echocardiography\r\n\r\n          -  Absence of alteration of gas exchange on maximum cardiopulmonary stress test\r\n             (elevation of gradient D (A-a) O2 > 35 mmHg at peak stress)\r\n\r\n          -  At least 2 of the following criteria: (i) a Nijmegen questionnaire score > 23, (ii)\r\n             the recurrence of at least two common symptoms during the maximum cardiopulmonary\r\n             stress test, (iii) delayed return of PETCO2 (partial pressure of end-tidal carbon\r\n             dioxide) to its basal value (> 5 minutes)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  The subject is participating in another study\r\n\r\n          -  The subject is in an exclusion period determined by a previous study\r\n\r\n          -  The subject is under judicial protection, or is an adult under any kind of\r\n             guardianship\r\n\r\n          -  The subject refuses to sign the consent\r\n\r\n          -  It is impossible to correctly inform the subject\r\n\r\n          -  The subject cannot fluently read French\r\n\r\n          -  The patient is pregnant\r\n\r\n          -  The patient is breastfeeding\r\n\r\n          -  The subject has a contra-indication (or an incompatible drug association) for a\r\n             treatment required during this study (a priori, there are no contra-indicated drugs)\r\n      ","sponsor":"University Hospital, Montpellier","sponsor_type":"Other","conditions":"Hyperventilation Syndrome","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Standard rehabilitation","description":"The patient will participate in a therapeutic education programme consisting of 4 visits (days 1 +- 14, 21 +- 14, 61 +- 14 and 90 +-14) representing usual procedures, which include: maintaining a diary, breathing coordination excercises, voluntary control of breathing rate, releasing contracted muscles, posture harmonization, a six minute walking test, and walking up four flights of stairs."},{"intervention_type":"Behavioral","name":"Behavioral: Nasal breathing rehabilitation","description":"The patient will participate in a therapeutic education programme consisting of 4 visits (days 1 +- 14, 21 +- 14, 61 +- 14 and 90 +-14) representing the experimental procedures, which include: maintaining a diary, evaluating nasal breathing by the nostril-alternating technique according to Anuloma Viloma Pranayama Yoga, releasing contracted muscles, posture harmonization, a six minute walking test, and walking up four flights of stairs."}],"outcomes":[{"outcome_type":"secondary","measure":"The slope of the equation VE=f(PETCO2)","time_frame":"Change between Day 0 and Day 90 +- 30","description":"VE = expiratory ventilation ; PETCO2 = end tidal carbon dioxide tension"},{"outcome_type":"secondary","measure":"PETCO2 value when VE = 0","time_frame":"Change between Day 0 and Day 90 +- 30","description":"VE = expiratory ventilation ; PETCO2 = end tidal carbon dioxide tension"},{"outcome_type":"primary","measure":"Change in Dyspnea at VO2max","time_frame":"Change between Day 0 and Day 90 +- 30","description":"Dyspnea measured at the first VO2max during a maximal cardio-pulmonary effort test. Dyspnea is measured using a visual analog scale."},{"outcome_type":"secondary","measure":"Time to start of mouth-breathing during exercise test","time_frame":"Change between Day 0 and Day 90 +- 30","description":"The delay of onset of oral ventilation during walking and / or on ergocycle"},{"outcome_type":"secondary","measure":"The SNOT22 questionnaire score","time_frame":"Change between Day 0 and Day 90 +- 30","description":"The SNOT22 questionnaire score"},{"outcome_type":"secondary","measure":"Ventilation during isowork","time_frame":"Change between Day 0 and Day 90 +- 30","description":"(Ventilation equivalents V'E / V'O2 and V'E / V'CO2)"},{"outcome_type":"secondary","measure":"PACO2 at rest","time_frame":"Change between Day 0 and Day 90 +- 30","description":"PAC02 = Partial pressure of carbon dioxide in arterial blood"},{"outcome_type":"secondary","measure":"pH at rest","time_frame":"Change between Day 0 and Day 90 +- 30","description":"pH at rest"},{"outcome_type":"secondary","measure":"PaO2 at rest","time_frame":"Change between Day 0 and Day 90 +- 30","description":"PaO2 = Partial pressure of oxygen in arterial blood"},{"outcome_type":"secondary","measure":"PACO2 at maximum effort","time_frame":"Change between Day 0 and Day 90 +- 30","description":"PAC02 = Partial pressure of carbon dioxide in arterial blood"},{"outcome_type":"secondary","measure":"pH at maximum effort","time_frame":"Change between Day 0 and Day 90 +- 30","description":"pH at maximum effort"},{"outcome_type":"secondary","measure":"PaO2 at maximum effort","time_frame":"Change between Day 0 and Day 90 +- 30","description":"PaO2 = Partial pressure of oxygen in arterial blood"},{"outcome_type":"secondary","measure":"Breathing rates during excerise testing","time_frame":"Change between Day 0 and Day 90 +- 30","description":"breaths per minute"},{"outcome_type":"secondary","measure":"Transcutaneous oximetry","time_frame":"Change between Day 0 and Day 90 +- 30","description":"tcpO2"},{"outcome_type":"secondary","measure":"Distance walked during 6 minute walking test","time_frame":"Change between Day 0 and Day 90 +- 30","description":"Distance walked during 6 minute walking test"},{"outcome_type":"secondary","measure":"Maximum rate of oxygen consumption","time_frame":"Change between Day 0 and Day 90 +- 30","description":"VO2max"},{"outcome_type":"secondary","measure":"Maximum dyspnea values","time_frame":"Change between Day 0 and Day 90 +- 30","description":"Dyspnea is measured using visual analogue scales"},{"outcome_type":"secondary","measure":"Dyspnea threshold during exercise testing","time_frame":"Change between Day 0 and Day 90 +- 30","description":"Dyspnea is measured using visual analogue scales"},{"outcome_type":"secondary","measure":"the equation P0.1=f(PETCO2)","time_frame":"Change between Day 0 and Day 90 +- 30","description":"P0.1 = occlusion pressure; PETCO2 = end tidal carbon dioxide tension"},{"outcome_type":"secondary","measure":"Dyspnea measured using the MRC scale","time_frame":"Change between Day 0 and Day 90 +- 30","description":"Dyspnea measured using the Medical Research Council scale"},{"outcome_type":"secondary","measure":"Nijmegen questionnaire score","time_frame":"Change between Day 0 and Day 90 +- 30","description":"Nijmegen questionnaire score"},{"outcome_type":"secondary","measure":"SF36 questionnaire score","time_frame":"Change between Day 0 and Day 90 +- 30","description":"SF36 questionnaire score"},{"outcome_type":"secondary","measure":"VQ-11 questionnaire score","time_frame":"Change between Day 0 and Day 90 +- 30","description":"VQ-11 questionnaire score"},{"outcome_type":"secondary","measure":"HAD questionnaire score","time_frame":"Change between Day 0 and Day 90 +- 30","description":"HAD questionnaire score"}]}
{"nct_id":"NCT03260699","start_date":"2017-10-05","phase":"N/A","enrollment":9,"brief_title":"Economic and Functional Impact of Peri-Operative Bracing for Primary Total Knee Arthroplasty (TKA)","official_title":"To Determine the Economic and Functional Impact of Peri-Operative Extension Assist Pneumatic Bracing for Primary Total Knee Arthroplasty (TKA) Non-Inferiority Trial","primary_completion_date":"2018-01-01","study_type":"Interventional","rec_status":"Terminated","completion_date":"2018-01-01","last_update":"2019-10-09","description":"While bracing has been shown to be beneficial for patients with osteoarthritis (OA) in terms of function and strength, whether these unloader braces are also similarly beneficial after total knee arthroplasty (TKA) surgery needs to be examined. Therefore the investigators questioned whether wearing a brace that has previously been shown to increase strength and function in OA patients can also increase strength and function in patients after TKA.","other_id":"SHB-OCSI007","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Age: 50 years or older\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  BMI > 40\r\n\r\n          -  Radiographic deformity of greater than 10 degrees\r\n      ","sponsor":"The Cleveland Clinic","sponsor_type":"Other","conditions":"Arthropathy of Knee","interventions":[{"intervention_type":"Device","name":"Device: OCSI Rehabilitator brace","description":"Guardian Brace features the innovative Rehabilitator line of gait correcting, leg strengthening braces. Rehabilitator Knee Braces are clinically proven to reduce UNBRACED pain, strengthen the affected leg, and significantly improve function after only 90 days of brace wear."}],"outcomes":[{"outcome_type":"secondary","measure":"Type of Pain Medication Used","time_frame":"Change from baseline to 12 weeks after surgery","description":"Investigators will monitor the medical record for types of pain medications used."},{"outcome_type":"primary","measure":"Number of Physical Therapy Visits","time_frame":"Total number of visits from date of surgery to 12 weeks after surgery","description":"Investigators will monitor the total number of physical therapy visits that was necessary to return to normal function between the control and bracing group and how it relates to overall cost."},{"outcome_type":"secondary","measure":"Visual Analog Scale (VAS) for Pain (0-10 Scale)","time_frame":"Change from baseline to 12 weeks after surgery","description":"Visual Analog Scale is a a pain scale assessment instrument that has been widely used to allow adult patients to report their pain level in musculoskeletal research studies. It is a continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length, anchored by 2 two ends representing the extremes of measurements with 0 point representing no pain and 10 representing the worst pain a patient may have had. Therefore, starting from zero point, increasing numbers demonstrate worse pain. Patient can pick a point on the scale that they believe represent their pain level at a given moment."},{"outcome_type":"secondary","measure":"Timed up and go Test (Timed Measurement)","time_frame":"Change from baseline to 12 weeks after surgery","description":"Used to assess a person's mobility and balance. It is measured in time units (seconds or minutes) using a stopwatch by a study personnel. To perform, the patient sits back in a standard arm chair and a line 3 meters, or 10 feet away on the floor is identified. At the investigator mark, the stopwatch is started and the patient is asked to stand up from chair, walk to the end of the line and come back to his chair at normal pace. The results is the time in seconds needed for the patient to perform the test (getting up from chair and coming back to it as timed by the investigator's stopwatch)"},{"outcome_type":"secondary","measure":"Timed Stair Climb (Timed Measurement Over Fixed Distance)","time_frame":"Change from baseline to 12 weeks after surgery","description":"Used to assess a person's mobility and balance"},{"outcome_type":"secondary","measure":"One-leg Stance Time (Timed Measurement)","time_frame":"Change from baseline to 12 weeks after surgery","description":"Used to assess a person's balance. Performed with eyes open and arms on hips. The patient is asked to stand unassisted on one leg and is timed in seconds (using stopwatch) from the time one foot is flexed off the floor to the time when it touches the ground or the standing leg or an arm leaves the hips."},{"outcome_type":"secondary","measure":"6 Minute Walk Test (Distance Measurement)","time_frame":"Change from baseline to 12 weeks after surgery","description":"Used to assess a person's endurance and aerobic capacity. The score of the test is distance a patient walks in 6 minutes. Longer distances walked by the patient in 6 minutes correlates with better performance. Distance is measured using distance measuring wheel."},{"outcome_type":"secondary","measure":"Knee Society Score Questionnaire","time_frame":"Change from baseline to 12 weeks after surgery","description":"Clinical outcome questionnaire developed by the consensus of the Knee Society. It comprises, a \"Knee score\" and a \"Functional score.\" The Knee score assesses pain, stability, and range of motion. A maximum score of 100 is achieved by a painless, well-aligned knee with 125° range of motion, with neither anteroposterior nor mediolateral instability. Deductions are made for flexion contracture, extension lag, and malalignment. The Functional score assesses walking distance and stair climbing. A maximum score of 100 is assigned to individuals who can walk unlimited distances and can climb up and down stairs normally. Deductions are made for use of a walking stick or crutches. Therefore, higher scores correlate with better function and outcome."},{"outcome_type":"secondary","measure":"Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS Jr.) Questionnaires","time_frame":"Change from baseline to 12 weeks after surgery","description":"Clinical outcome questionnaire that measure joint-specific pain and physical function. It has seven questions that focus on three categories: joint pain, stiffness, and function, in daily living. Raw scores are added up (range 0-28) and converted to an interval score (0-100) using an interval table. The interval score represents a patients total joint disability where 0 corresponds to total joint disability and 100 perfect joint health."},{"outcome_type":"secondary","measure":"Hospital for Special Surgery (HSS) Score (0-100 Scale)","time_frame":"Change from baseline to 12 weeks after surgery","description":"Clinical outcome assessment tool. It is based on a total of 100 points. The score is divided into seven categories, which include pain, function, range of motion, muscle strength, flexion deformity, instability, and subtractions. The knee is initially given a score of 0, and additions or subtractions are made according to specific criteria. The higher the score, the better the outcome. Approximately 50% of the score is based on a patient interview and the remaining on physical exam."},{"outcome_type":"secondary","measure":"Amount of Pain Medication Used","time_frame":"Change from baseline to 12 weeks after surgery","description":"Investigators will monitor the medical record for the amount of pain medication used"}]}
{"nct_id":"NCT03253692","start_date":"2017-10-03","enrollment":36,"brief_title":"Prospective Multicenter Registry On Radiation Dose Estimates Of Cardiac CT Angiography in Daily Practice in 2017 (PROTECTION VI)","official_title":"Prospective Multicenter Registry On Radiation Dose Estimates of Cardiac CT Angiography in Daily Practice in 2017 (PROTECTION VI)","primary_completion_date":"2018-06-30","study_type":"Observational","rec_status":"Completed","completion_date":"2018-10-11","last_update":"2021-05-21","description":"Background: CCTA is a common way to evaluate coronary artery disease. It stands for coronary computed tomography angiography. It uses scanning to look at the arteries that supply blood to the heart. It is noninvasive, widely available, and generally accurate. But it does expose people to radiation. Exposure to high amounts of radiation can increase a person s risk of getting cancer. Researchers want to learn more about the relationship between CCTA and radiation exposure. Objective: To see how much radiation is used to take pictures of the heart and how measures to reduce radiation are used around the world. Eligibility: People ages 18 years and older who need a computed tomography (CT) scan of the heart Design: Participants will be screened with a review of their medical records. Participants may have a pregnancy test. Participants will have the scheduled scan. Small, sticky discs will be placed on the chest. A small tube will be placed into a vein in the arm. A contrast material (dye) will be given through it. Participants will lie on the CT scanning table. A CCTA scan usually takes about 15 minutes if the heart rate is slow and steady.","other_id":"170146","observational_model":"Case-Only","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":100,"population":"Data confirming the inclusion/exclusion criteria will be confirmed at the study visit.\r\n        Overall, up to 100 subjects will be enrolled locally at the NIH. A member of the study team\r\n        will review the CT procedures and confirm that the participants do not have any serious\r\n        health problems or concomitant conditions or medications that would prevent them from\r\n        having the CT. A member of the study team will perform a pregnancy test (if applicable) in\r\n        female participants of childbearing potential. If @@@you are nursing, you will be excluded\r\n        from this study. All tests will follow NIH Clinical Center policies and clinical consent\r\n        forms for individual tests may be obtained in addition to the study protocol consent as\r\n        applicable. Sites outside the NIH will use similar standard of care procedures for cardiac\r\n        CT eligibility.","criteria":"\n        -  INCLUSION CRITERIA:\r\n\r\n               1. Clinical indication for cardiac CT angiography to evaluate coronary arteries or\r\n                  other cardiac structures\r\n\r\n               2. Age equal to or greater than 18 years\r\n\r\n               3. Able to understand and willing to sign the Informed Consent Form\r\n\r\n        EXCLUSION CRITERIA:\r\n\r\n        1) Female participants who are pregnant or nursing\r\n      ","sponsor":"National Heart, Lung, and Blood Institute (NHLBI)","sponsor_type":"NIH","conditions":"Coronary Artery Disease|Coronary Disease|Myocardial Ischemia|Arterial Occlusive Diseases|Arteriosclerosis","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Determine radiation dose estimates of cardiac CT angiographies in daily practice","time_frame":"day 0","description":"We will assess the variation of radiation dose with respect to vendors, CT systems and study sites. Furthermore, we will evaluate the usage of dose saving strategies including the abovementionedin daily practice and analyze their effect on diagnostic image quality. On the basis of the collected data, we will evaluate the potential use of additional dose savings for each individual site."}]}
{"nct_id":"NCT03013400","start_date":"2017-10-01","phase":"Phase 2","enrollment":60,"brief_title":"Ebselen as an add-on Treatment in Hypo/Mania","official_title":"A Randomised, Parallel Group, Double Blind, Placebo Controlled, Add on Clinical Trial to Investigate Whether the Lithium Mimetic, Ebselen, Can Reduce Symptoms of Hypomania and Mania in Bipolar Patients","primary_completion_date":"2019-07-09","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-07-09","last_update":"2019-09-06","description":"This study evaluates the effect of a 'lithium like' drug called ebselen (SP-1005) versus placebo as an 'add on' treatment to help stabilise hypo/manic symptoms in bipolar disorder. Half of the participants will receive ebselen and the other half placebo. The trial, will last a total of four weeks.","other_id":"172518","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Participant is willing and able to give informed consent for participation in the\r\n             trial.\r\n\r\n          -  Male or Female, aged 18-70 years\r\n\r\n          -  Diagnosed with bipolar disorder, screened using the Structured Clinical Interview for\r\n             DSM-5 (SCID) to meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5)\r\n             criteria for Manic or Hypomanic Episode.\r\n\r\n          -  Female participants of child bearing potential and male participants whose partner is\r\n             of child bearing potential must be willing to ensure that they or their partner use\r\n             effective contraception during the trial\r\n\r\n          -  In the Investigator's opinion, is able and willing to comply with all trial\r\n             requirements.\r\n\r\n          -  Willing to allow clinical care team (including General Practitioner (GP)) to be made\r\n             aware of trial participation.\r\n\r\n          -  The Clinical team treating the patient are in agreement.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Female participant who is pregnant, lactating or planning pregnancy during the course\r\n             of the trial.\r\n\r\n          -  Known significant renal or hepatic impairment.\r\n\r\n          -  Scheduled elective surgery or other procedures requiring general anaesthesia during\r\n             the trial.\r\n\r\n          -  Any other significant disease or disorder which, in the opinion of the Investigator,\r\n             may either put the participants at risk because of participation in the trial, or may\r\n             influence the result of the trial, or the participant's ability to participate in the\r\n             trial.\r\n\r\n          -  Participants who have participated in another research trial involving an\r\n             investigational product in the past 12 weeks.\r\n\r\n          -  Clinically significant illicit substance or alcohol misuse where dependence criteria\r\n             are satisfied.\r\n\r\n          -  Taking lithium.\r\n\r\n          -  Previous randomisation to this trial.\r\n      ","sponsor":"University of Oxford","sponsor_type":"Other","conditions":"Bipolar Disorder|Bipolar Disorder, Manic","interventions":[{"intervention_type":"Drug","name":"Drug: Ebselen","description":"Ebselen is an opaque capsule containing 200 mg of ebselen is a selenium-based GPx mimic and IMPase inhibitor."},{"intervention_type":"Drug","name":"Drug: Placebo oral capsule","description":"Placebo is identical in appearance to the ebselen capsules"}],"outcomes":[{"outcome_type":"primary","measure":"Change in Young Mania Rating Scale (YMRS)","time_frame":"Change between groups, every week, up to 4 weeks","description":"Difference in the 11 item clinician-rated YMRS between groups.Total score 0-60."},{"outcome_type":"secondary","measure":"Change in Clinical Global Impressions Bipolar (CGI-BP) mania scale","time_frame":"Change between groups, every week, up to 4 weeks","description":"Improvement due to treatment between groups. Very much improved to very much worse."},{"outcome_type":"secondary","measure":"Change in Altman Self Rating Mania Scale (ASRM)","time_frame":"Change between groups, 3 x weekly, up to 4 weeks","description":"Difference in the 5 item self-rated ASRM between groups.Total score 0-20."},{"outcome_type":"secondary","measure":"Change in Hamilton Rating Scale for Depression (HAM-D)","time_frame":"Change between groups, every week, up to 4 weeks","description":"Difference in the 17 item Clinician-rated HAM-D between groups. Total score 0-52."},{"outcome_type":"secondary","measure":"Change in Quick Inventory of Depressive Symptomology-Self Rating 16 (QIDS-SR-16)","time_frame":"Change between groups, 3 x weekly, up to 4 weeks","description":"Difference in the 16 item self-rated QIDS-SR-16 between groups. Total score 0-42."},{"outcome_type":"secondary","measure":"Change in Actigraphy","time_frame":"Change in activity between groups, each 24 hours, up to 4 weeks","description":"To compare the effect of ebselen versus placebo on motor behaviour and the sleep-wake cycle"},{"outcome_type":"secondary","measure":"Change in Leeds Sleep Evaluation Questionnaire (LSEQ)","time_frame":"Change between groups, every week, up to 4 weeks","description":"Difference in the 4 self-rated sleep domains (10 visual analogue scales) between groups."},{"outcome_type":"secondary","measure":"Levels of markers of inflammation in Plasma sample","time_frame":"Once at week 1 visit","description":"To compare the effect of ebselen, versus placebo, on markers of inflammation including C-Reactive Protein and antibodies to common infectious agents such as human herpesviruses and Toxoplasma gondii"},{"outcome_type":"secondary","measure":"Ebselen levels in Plasma sample","time_frame":"Once at week 1 visit","description":"To assess ebselen levels in plasma"},{"outcome_type":"secondary","measure":"Adverse Events reported","time_frame":"Every week, up to 4 weeks","description":"Self-rated Side Effects Questionnaire"},{"outcome_type":"secondary","measure":"Change in Concomitant medication recorded","time_frame":"Change between groups, every week, up to 4 weeks","description":"To assess the overall use of concomitant medication during the trial period"},{"outcome_type":"secondary","measure":"Compliance assessment","time_frame":"Change between groups, every week, up to 3 weeks","description":"capsule count and records checked"},{"outcome_type":"other","measure":"Researcher and participant blinding questionnaire to determine treatment concealment","time_frame":"Once, at week 4","description":"Researcher and participant blinding questionnaire"},{"outcome_type":"other","measure":"Participant and Researcher Randomisation Guess Visual Analogue Scale (VAS)","time_frame":"Once, at week 4","description":"To assess whether researchers and participants could guess the assigned randomised arm"},{"outcome_type":"other","measure":"Public Participant Involvement (PPI) feedback questionnaire","time_frame":"Once, at week 4","description":"PPI questionnaire"}]}
{"nct_id":"NCT03334591","start_date":"2017-10-01","phase":"Phase 2","enrollment":60,"brief_title":"Research On the Optimized Treatment Method For Apatinib's Cure Of Advanced Gastric Cancer","official_title":"Research On the Optimized Treatment Method For Apatinib's Cure Of Advanced Gastric Cancer","primary_completion_date":"2019-10-01","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-12-01","last_update":"2017-11-14","description":"The investigators hope that after this research, two different treatment methods' curative effects for advanced gastric cancer can be assessed. One is continuous use of apatinib, the other is 5 days' continuous use and 2 days' off of apatinib.","other_id":"HYF001","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Male and female patients,age18years\r\n\r\n          2. Confirmed by Pathology or histology of Gastric cancer\r\n\r\n          3. Patients who failed first-line chemotherapy\r\n\r\n          4. The ECOG physical status score:0 to 2\r\n\r\n          5. Expected survival 3months\r\n\r\n          6. Patients should be voluntary to the trail and provide with signed informed consent.\r\n\r\n          7. The researchers believe patients can benefit from the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Pregnant or lactating women\r\n\r\n          2. Patients with a knowm history of allergic reactions and/ou hypersensitivity attributed\r\n             to apatinib or its accessories\r\n\r\n          3. Patients with apatinib contraindications\r\n\r\n          4. Patients of doctors considered unsuitable for the trail\r\n      ","sponsor":"Anhui Provincial Hospital","sponsor_type":"Other","conditions":"Two Different Treatment Methods","interventions":[{"intervention_type":"Drug","name":"Drug: Apatinib","description":"Apatinib 500mg with Docetaxel 60mg/m2"}],"outcomes":[{"outcome_type":"secondary","measure":"disease control rate (DCR)","time_frame":"1year","description":"investigators will assess treatment response according to Response Evaluation Criteria in Soid Tumor"},{"outcome_type":"primary","measure":"progress free survival(PFS)","time_frame":"1 year","description":"From data of randomization until the date of first dccumentde progression or date of death from any cause"},{"outcome_type":"secondary","measure":"Objective tumor response rate(ORR)","time_frame":"1year","description":"difined as the percentage of subjects having achieved confirmed Complete Response+Partial Response as best overall response according to radiological assessments"},{"outcome_type":"secondary","measure":"overall survival (os)","time_frame":"1year","description":"difined as the length of time from random assignment to death or to last contact"},{"outcome_type":"secondary","measure":"Quality of life score","time_frame":"1 year","description":"a questionnaire developed to assess the quality of life of cancer patients"},{"outcome_type":"secondary","measure":"adverse events","time_frame":"1 year","description":"adverse events are evaluated according to National Cancer institute Common Terminology Criteria for Adverse Events"}]}
{"nct_id":"NCT03324152","start_date":"2017-10-01","phase":"N/A","enrollment":30,"brief_title":"Effects of High-intensity Interval Training (HIIT) in Recent Onset Polymyositis and Dermatomyositis","official_title":"Effects of High-intensity Interval Training (HIIT) Compared to Low-intensity Exercise in Patients With Recent Onset Polymyositis and Dermatomyositis - a Randomized Controlled Trial","primary_completion_date":"2020-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-12-31","last_update":"2018-04-23","description":"Polymyositis and dermatomyositis are rare inflammatory systemic conditions. Reduced muscle function is a cardinal symptom and lung involvement is very common. Knowledge of heart involvement in these patients is very limited, as is knowledge of exercise effects in recent onset, active disease. The aim of this project is to investigate effects of high-intensity interval training (HIIT) compared to standard low-intensity home exercise as to tolerance, physical capacity, quality of life, depression, disease activity, inflammation, muscle mass/fat mass, muscle metabolism and heart function in patients with recent onset, active polymyositis and dermatomyositis. This is a randomized controlled trial. Muscle biopsies are taken at time of diagnosis and after 12 weeks of exercise. Muscle biopsies will be analyzed as to baseline kynurenine pathway, calcium release, gene expression and inflammatory infiltrates and as to changes in these parameters following exercise. Muscle function (primary outcome), maximal oxygen uptake, muscle mass/fat mass, disease activity, systolic and diastolic heart function, as well as quality of life and depression is measured at baseline and after 12 weeks of exercise. After all assessments, patients are randomized to HIIT or standard low-intensity home exercise. The HIIT group will perform 6 sets of 30-60 second biking bouts reaching 85-100% of maximal heart rate, in combination with strength training, three days a week for 12 weeks. The control group will perform a standardized home exercise program five days a week for 12 weeks. After 12 weeks, all assessments are preformed again. If the HIIT is well tolerated, patients in the control group will be invited to HIIT exercise according to the same protocol. Clinical assessments will be performed at 3, 6 and 9 months follow-up in an open extension. This study will improve our understanding of heart function, muscle metabolism as well as tolerance and effects of intensive exercise as well as heart function early in the disease course and could also improve treatment and prognosis in patients with polymyositis and dermatomyositis.","other_id":"KarolinskaUH1","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","intervention_model_description":"Patients are dandomized to either a high-intensity interval group (HIIT) or a control group performing standard low-intensity home exercise.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Patients with polymyositis and dermatomyositis:\r\n\r\n        Inclusion Criteria:\r\n\r\n          -  Probable or definite diagnosis polymyositis or dermatomyositis according to Bohand and\r\n             Peter criteria, diagnosis duration between 4 weeks and 6 months, completed screening\r\n             for possible concurrent cancer diagnosis and screening for lung involvement, able to\r\n             performe the HIIT.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Diagnosis of inclusion body myositis, active cancer, being treated for cancer, heart-\r\n             or lung involvement contraindicating HIIT, no clinical improvement with medical\r\n             treatment, severe osteoporosis.\r\n\r\n        Healthy controls:\r\n\r\n        Inclusion Criteria: match a patient for age and gender, exercising not more than twice a\r\n        week, no neuro- or musculoskeletal disorders.\r\n\r\n        Exclusion Criteria: Ongoing treatment for cancer, cardiovascular disease contraindicating a\r\n        maximal oxygen uptake test or HIIT.\r\n      ","sponsor":"Karolinska University Hospital","sponsor_type":"Other","conditions":"Polymyositis|Dermatomyositis","interventions":[{"intervention_type":"Other","name":"Other: High-intensity interval training (HIIT) - myositis","description":"12-weeks of 3 days/week HIIT. 6 sets of 30-60 seconds on 85-100% of maximal heart rate performed on a stationary bike followed by resistance training on 10 voluntary repetition maximum."},{"intervention_type":"Other","name":"Other: Standard low-intensity home exercise","description":"12 weeks of 5 days/week low-intensity resistance home exercise in combination with outdoor walks of 20 minutes."},{"intervention_type":"Other","name":"Other: High-intensity interval training (HIIT) - healthy","description":"12-weeks of 3 days/week HIIT. 6 sets of 30-60 seconds on 85-100% of maximal heart rate performed on a stationary bike followed by resistance training on 10 voluntary repetition maximum."}],"outcomes":[{"outcome_type":"secondary","measure":"Myositis Damage Index (MDI) heart","time_frame":"6 months","description":"Degree of damage of the heart is assessed on a VAS, 0-100."},{"outcome_type":"secondary","measure":"Myositis Damage Index (MDI) gastro-intestinal tract","time_frame":"6 months","description":"Degree of GI-tract damage is assessed on a VAS, 0-100."},{"outcome_type":"secondary","measure":"Myositis Damages Index (MDI) Skeletal","time_frame":"6 months","description":"Degree of joint damage and osteoporosis is assessed on a VAS, 0-100."},{"outcome_type":"primary","measure":"VO2 max, L/min and ml/kgxmin","time_frame":"12 weeks","description":"A maximal oxygen uptake test with ECG on a stationary bike. For patients with myositis, the test is started on 30W and increasing with 10W every minute until exhaustion. Ventilation and gas exchanges is assessed. Definition of max: ration CO2 / O2 = >1. The test is stopped when maximal effort according to above definition is reached or when the subjects cannot bike any longer due to exhaustion. Healthy subjects will start on 50W and then follow the same protocol. Subjects rate subjective exertion of thigh muscles, dyspnea on the Borg symptom scale, 0-10. After completion of test overall exertion is rated on the Borg RPE scale, 6-20."},{"outcome_type":"secondary","measure":"Aerobic capacity, Watt max","time_frame":"12 weeks","description":"A maximal oxygen uptake test with ECG on a stationary bike. For patients with myositis, the test is started on 30W and increasing with 10W every minute until exhaustion. Ventilation and gas exchanges is assessed. Definition of max: ration CO2 / O2 = >1. The test is stopped when maximal effort according to above definition is reached or when the subjects cannot bike any longer due to exhaustion. Healthy subjects will start on 50W and then follow the same protocol. Subjects rate subjective exertion of thigh muscles, dyspnea on the Borg symptom scale, 0-10. After completion of test overall exertion is rated on the Borg RPE scale, 6-20."},{"outcome_type":"secondary","measure":"Myositis Disease Activity Assessment Tool (MDAAT) - physician's global assessment.","time_frame":"12 weeks","description":"A myositis-specific protocol in Biodex systems is used. After completing measures of MVIC, the subjects perform six sets of 12, 4-second contractions with a 6-second rest in-between. Set 1: 12 contractions on 20% of MVIC. For each set, intensity is increased by 10%. In the last, 6th set contractions are performed on 70% of MVIC. After each set, a new MVIC is tested. The MDAAT is a valid core set of measures to assess disease activity including physician's and patient's global assessment, measures of muscle strength, activity limitation and extra-muscular organ activity. Physician's global assessment is performed in a Visual Analogue Scale (VAS), 0-100."},{"outcome_type":"secondary","measure":"Myositis Disease Activity Assessment Tool (MDAAT) - patient's global assessment","time_frame":"12 weeks","description":"The MDAAT Patient's global assessment is performed in a Visual Analogue Scale (VAS), 0-100."},{"outcome_type":"secondary","measure":"Myositis Disease Activity Assessment Tool (MDAAT) - Manual Muscle Test","time_frame":"12 weeks","description":"The MDAAT Manual muscle test measures isometric muscle strength in 8 muscle groups with a composite score varying from 0-80, where 8 indicates good muscle strength."},{"outcome_type":"secondary","measure":"Myositis Disease Activity Assessment Tool (MDAAT) - Health Assessment Questionnaire (HAQ).","time_frame":"12 weeks","description":"The MDAAT, HAQ includes 20 questions about ability to perform daily activities with a composite score varying from 0-3, where 3 indicates severe limitations."},{"outcome_type":"secondary","measure":"Myositis Disease Activity Assessment Tool (MDAAT) - serum creatine phosphokinase (CK).","time_frame":"12 weeks","description":"The MDAAT, serum CK-levels is measured in mikrocat/L."},{"outcome_type":"secondary","measure":"Myositis Disease Activity Assessment Tool (MDAAT) - MYOACT constitutional","time_frame":"12 weeks","description":"The MDAAT, MYOACT constitutional (fever, weight loss) is assessed on a VAS, 0-100."},{"outcome_type":"secondary","measure":"Myositis Disease Activity Assessment Tool (MDAAT) - MYOACT heart","time_frame":"12 weeks","description":"The MDAAT, MYOACT heart involvement is assessed on a VAS, 0-100."},{"outcome_type":"secondary","measure":"Myositis Disease Activity Assessment Tool (MDAAT) - MYOACT lung","time_frame":"12 weeks","description":"The MDAAT, MYOACT lung involvement is assessed on a VAS, 0-100."},{"outcome_type":"secondary","measure":"Myositis Disease Activity Assessment Tool (MDAAT) - MYOACT skeletal","time_frame":"12 weeks","description":"The MDAAT, MYOACT skeletal (joint inflammation and bone density) involvement is assessed on a VAS, 0-100."},{"outcome_type":"secondary","measure":"Myositis Disease Activity Assessment Tool (MDAAT) - MYOACT gasto-intestinal tract.","time_frame":"12 weeks","description":"The MDAAT, MYOACT gastro-intestinal tract involvement such as dysphagia is assessed on a VAS, 0-100."},{"outcome_type":"secondary","measure":"Myositis Disease Activity Assessment Tool (MDAAT) - MYOACT skin","time_frame":"12 weeks","description":"The MDAAT, MYOACT skin involvement (skin rash) is assessed on a VAS, 0-100."},{"outcome_type":"secondary","measure":"Myositis Damage Index (MDI) - muscle","time_frame":"6 months","description":"Degree of skeletal muscle damage is assessed on a VAS, 0-100"},{"outcome_type":"secondary","measure":"Myositis Damage Index (MDI) - lung","time_frame":"6 months","description":"Degree of lung dagame is assessed on a VAS, 0-100"},{"outcome_type":"secondary","measure":"Stress echocardiography","time_frame":"12 weeks","description":"Systolic and diastolic heart function is assessed by ultrasound of the heart."},{"outcome_type":"secondary","measure":"Inflammatory infiltrates in skeletal muscle","time_frame":"12 weeks","description":"Muscle biopsies are analyzed for inflammatory infiltrates with immunohistochemistry."},{"outcome_type":"secondary","measure":"Gene expression","time_frame":"12 weeks","description":"Muscle biopsies are analyzed with Micro Array technique"},{"outcome_type":"secondary","measure":"ER-stress","time_frame":"12 weeks","description":"Muscle biopies are analysed by ELIZA"},{"outcome_type":"secondary","measure":"Proteins involved in kynurenine process","time_frame":"12 weeks","description":"Muscle biopsies are analyzed by ELIZA"},{"outcome_type":"secondary","measure":"Proteins involved in calcium release","time_frame":"12 weeks","description":"Muscle biopsies are analyzed by ELIZA"},{"outcome_type":"secondary","measure":"Isometric muscle strength","time_frame":"12 weeks","description":"A myositis-specific protocol in Biodex systems is used. Following several familiarization sets, maximal voluntary isometric contraction (MVIC) is tested until three very similar contractions are recorded. The subjects rest one minute between each MVIC."},{"outcome_type":"secondary","measure":"Isomteric muscle fatigability","time_frame":"12 weeks","description":"A myositis-specific protocol in Biodex systems is used. After completing measures of MVIC, the subjects perform six sets of 12, 4-second contractions with a 6-second rest in-between. Set 1: 12 contractions on 20% of MVIC. For each set, intensity is increased by 10%. In the last, 6th set contractions are performed on 70% of MVIC. After each set, a new MVIC is tested."}]}
{"nct_id":"NCT03638713","start_date":"2017-10-01","phase":"N/A","enrollment":200,"brief_title":"Comparison of Procedural Sequences in Same-day Painless Bidirectional Endoscopy With Colonoscopic Water Exchange Method","official_title":"Division of Gastroenterology, Department of Internal Medicine, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan","primary_completion_date":"2020-10-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2020-10-31","last_update":"2019-11-13","description":"This prospective randomized controlled trial is to compare evaluate the optimal procedure sequence among patients undergoing water exchange colonoscopy.","other_id":"A10604001","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","intervention_model_description":"A total of 200 patients were allocated into one of two groups by computerized randomization. Patients in the group A (colonoscopy first group) received colonoscopy followed by EGD and those in the group B (EGD first group) received EGD followed by colonoscopy.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients underwent fully sedated bidirectional endoscopy in the physical check-up\r\n             department\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who < 18 years old, > 80 years old\r\n\r\n          -  Without standard colon preparation\r\n\r\n          -  Allergy to meperidine or propofol\r\n\r\n          -  With a history of partial colectomy\r\n\r\n          -  Refusal to provide written informed consent\r\n\r\n          -  American Society of Anesthesiology (ASA) risk Class 3 or higher\r\n      ","sponsor":"Dalin Tzu Chi General Hospital","sponsor_type":"Other","conditions":"Colon Disease|Bidirectional Endoscopy","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: colonoscopy first","description":"Received water exchange colonoscopy followed by EGD"},{"intervention_type":"Behavioral","name":"Behavioral: EGD first","description":"Received EGD followed by water exchange colonoscopy"}],"outcomes":[{"outcome_type":"primary","measure":"cecal insertion time","time_frame":"30 minutes","description":"Cecal insertion time was defined as the time from insertion into the rectum to the time when the colonoscope tip passed to a point proximal to the ileocecal valve so that the base of cecum was visible."}]}
{"nct_id":"NCT03281707","start_date":"2017-09-30","enrollment":50,"brief_title":"NIRS and DO2i Correlation","official_title":"Evaluation of NIRS and DO2i Correlation and Their Relationship With Organ Failure During Cardiac Surgery: a Prospective Monocentric Study.","primary_completion_date":"2018-10-30","study_type":"Observational [Patient Registry]","rec_status":"Unknown status","completion_date":"2018-10-30","last_update":"2017-09-13","description":"This study evaluates the association between near infrared spectroscopy (NIRS) and indexed oxygen delivery (DO2i) and their possible correlation with postoperative organ failure.","other_id":"R627/17-CCM 662","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients undergoing cardiac surgery","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  All patients undergoing cardiac surgery with cardiopulmonary by-pass whose have been\r\n             signed the consent informed\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Impossibilty to collect a correct continuous cardiac output measure with PiCCO\r\n             (chronic atrial fibrillation or severe peripheral vasculopaty)\r\n      ","sponsor":"Centro Cardiologico Monzino","sponsor_type":"Other","conditions":"Multiorgan Failure|Perfusion; Complications","interventions":[{"intervention_type":"Procedure","name":"Procedure: NIRS","description":"NIRS devices patch will be applied on patients' head in order to measure the cerebral saturation of each cerebral emisphere"},{"intervention_type":"Other","name":"Other: DO2i","description":"Oxygen delivery standardized to the body surface area will be calculate in order to optimize tissue perfusion"}],"outcomes":[{"outcome_type":"primary","measure":"Evaluate the correlation between NIRS and DO2i during cardiac surgery","time_frame":"Intraoperative"},{"outcome_type":"secondary","measure":"Evaluate the correlation between NIRS, DO2i and SOFA score","time_frame":"7 days postoperative"}]}
{"nct_id":"NCT03253315","start_date":"2017-09-30","enrollment":20,"brief_title":"Management of Pericarditis in Children.","official_title":"Clinical Audit of the Management of Pericarditis in Children.","primary_completion_date":"2018-09-30","study_type":"Observational [Patient Registry]","rec_status":"Unknown status","completion_date":"2019-04-30","last_update":"2017-08-17","description":"The pericardium is a double-walled sac containing the heart and the roots of the great vessels. The pericardial sac has two layers, a serous visceral l layer (also known as epicardium when it comes into contact with the myocardium) and a fibrous parietal layer. It encloses the pericardial cavity, which contains pericardial fluid. The pericardium fixes the heart to the mediastinum, gives protection against infection and provides lubrication for the heart. Pericardial diseases may be either isolated disease or part of a systemic disease Diseases of the pericardium present clinically in one of several ways - Acute and recurrent pericarditis - Pericardial effusion without major hemodynamic compromise - Cardiac tamponade with cardiac compromise - Constrictive pericarditis","other_id":"ayafadl24791","observational_model":"Other","time_perspective":"Other","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":1,"maximum_age":18,"population":"patients who above one year of age up to 18 years diagnosed with pericarditis and/or\r\n        pericardial effusions are candidates for the study.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Children with pericarditis and/or pericardial effusion above one year of age detected\r\n             clinically and by echocardiography\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  children below one year of age. - children with malignant effusion.\r\n      ","sponsor":"Assiut University","sponsor_type":"Other","conditions":"Pericarditis","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Echocardiographic signs","time_frame":"one month","description":"normal cardiac size by echocardiography (measurable by echocardiographic probe)\r\nnormal thickening of pericardium by echocardiography .(measurable by echocardiographic probe)"}]}
{"nct_id":"NCT03300921","start_date":"2017-09-28","phase":"Phase 1","enrollment":3,"brief_title":"A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer","official_title":"A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer","primary_completion_date":"2020-08-30","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2021-10-31","last_update":"2021-03-25","description":"The main purpose of this study is to look at the potential effects of paricalcitol (a drug similar to vitamin D) on pancreatic tumors in patients who are planned for surgical removal of their tumor. The study will also look at the safety of paricalcitol prior to surgery.","other_id":"UPCC 26217","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Arm A: 50mcg IV weekly Arm B: 12mcg PO daily","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Previously untreated, apparently resectable, adenocarcinoma of the pancreas at\r\n             registration.\r\n\r\n          -  Age greater than or equal to 18 years\r\n\r\n          -  Medically fit for surgery in the opinion of the treating surgeon\r\n\r\n          -  Ability to provide written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n        - Patients who are currently pregnant, planning to become pregnant, or breast-feeding.\r\n\r\n        Note: women of childbearing potential must agree to use a medically accepted form of birth\r\n        control including (condoms, diaphragms, cervical cap, an intra-uterine device (IUD),\r\n        surgical sterility [tubal ligation or a partner that has undergone a vasectomy], or oral\r\n        contraceptives). OR must agree to completely abstain from intercourse for two weeks before\r\n        beginning study treatment, during participation in this study, and for 2 weeks after the\r\n        final study treatment\r\n\r\n          -  Patients with hypercalcemia (blood levels greater than 11.5 mg/dL). Note: In patients\r\n             with GFR 30-60 mL/min by Cockroft-Gault, blood calcium levels must be 9.5 mg/dL or\r\n             lower before starting paricalcitol.\r\n\r\n          -  Serum creatinine > 2.5 x ULN OR GFR <30 mL/min by Cockroft-Gault formula . Patients\r\n             who, in the opinion of the physician, would not be clinically appropriate for receipt\r\n             of the therapy regimen associated with participation.\r\n      ","sponsor":"Abramson Cancer Center of the University of Pennsylvania","sponsor_type":"Other","conditions":"Pancreatic Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Paricalcitol","description":"Product: Paricalcitol\r\nDose/Route/Regimen:\r\nArm A: 50mcg IV weekly Arm B: 12mcg PO daily"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Adverse Events","time_frame":"18 months"}]}
{"nct_id":"NCT03295786","start_date":"2017-09-26","phase":"Phase 1/Phase 2","enrollment":17,"brief_title":"Clinical Study to Test the Safety of CDNF by Brain Infusion in Patients With Parkinson's Disease","official_title":"Phase 1-2, Randomised, Double-Blind, Placebo Controlled, Safety and Tolerability Study of Intraputamenal Cerebral Dopamine Neurotrophic Factor (CDNF) Infusions Via an Investigational Drug Delivery System to Patients With Parkinson's Disease","primary_completion_date":"2019-12-19","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-12-19","last_update":"2020-01-13","description":"This study evaluates the safety and tolerability of CDNF in patients with Parkinson's disease, when dosed directly into the brain using an implanted investigational drug delivery system (DDS). Safety and accuracy of the DDS is also being evaluated. One-third of the patients will receive monthly infusions with placebo and two-third of the patients will receive monthly infusions with either mid- or high-doses of CDNF for a period of 6 months.","other_id":"HP-CD-CL-2002","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","intervention_model_description":"Randomised, Double-Blind, Placebo Controlled","sampling_method":"","gender":"All","minimum_age":35,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Idiopathic Parkinson's disease based on UK brain bank criteria\r\n\r\n          2. Duration of PD motor symptoms 5-15 years (inclusive)\r\n\r\n          3. Age 35-75 years (inclusive)\r\n\r\n          4. Presence of motor fluctuations.\r\n\r\n          5. At least 5 daily doses of levodopa\r\n\r\n          6. Ability to reliably distinguish motor states and accurately complete fluctuation\r\n             diaries\r\n\r\n          7. UPDRS motor score (part III) in a practically defined OFF-state between 25-50\r\n             (inclusive)\r\n\r\n          8. Hoehn and Yahr  stage III in the OFF-state\r\n\r\n          9. Responsiveness to levodopa\r\n\r\n         10. No change in anti-parkinsonian medication for 6 weeks before screening\r\n\r\n         11. Provision of Informed Consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Diagnosed with atypical parkinsonism or any known secondary parkinsonian syndrome.\r\n\r\n          2. Signs or symptoms suggestive of atypical parkinsonian syndrome.\r\n\r\n          3. Drug-resistant rest tremor.\r\n\r\n          4. Prior neurosurgical treatment for PD, including lesioning or deep brain stimulation\r\n\r\n          5. Significant neurological disorder other than PD including clinically significant head\r\n             trauma, cerebrovascular disease, epilepsia, CSF shunt or other implanted CNS device\r\n\r\n          6. Presence of significant depression as defined as a BDI score  20\r\n\r\n          7. Current psychosis requiring therapy.\r\n\r\n          8. Presence of clinically significant impulse control disorder ((QUIP-RS) score > 20),\r\n             or, presence of dopamine dysregulation syndrome.\r\n\r\n          9. MoCA score < 24.\r\n\r\n         10. Use within 3 months of planned catheter insertion of concomitant medications known to\r\n             affect PD symptoms other than prescribed PD therapy.\r\n\r\n         11. Any medical condition, which might impair outcome measure assessments or safety\r\n             measures including ability to undergo MRI or DAT-PET.\r\n\r\n         12. Hypersensitivity or allergy to gadolinium or to any of excipients of macrocyclic GBCA\r\n             used for the surgical planning MRI.\r\n\r\n         13. Screening and/or planning MRI demonstrating any abnormality, which would suggest an\r\n             alternative cause for patient's parkinsonism or preclude neurosurgery.\r\n\r\n         14. Any medical condition that would put the patient at undue risk from surgical treatment\r\n             or chronic implants including but not limited to bleeding disorders, chronic\r\n             infections, or immunosuppressive illness\r\n\r\n         15. History within the last 5 years of cancer with the exception of basal cell carcinoma\r\n             of the skin\r\n\r\n         16. History of drug or alcohol abuse within 2 years of screening\r\n\r\n         17. Use of any investigational drug or device within 90 days of screening\r\n\r\n         18. Active breastfeeding\r\n      ","sponsor":"Herantis Pharma Plc.","sponsor_type":"Industry","conditions":"Parkinson Disease|Movement Disorders|Neurodegenerative Diseases|Nervous System Diseases|Brain Diseases","interventions":[{"intervention_type":"Drug","name":"Drug: Cerebral Dopamine Neurotrophic Factor","description":"Repeated intracerebral infusions"},{"intervention_type":"Device","name":"Device: Renishaw Drug Delivery System","description":"Stereotactically implanted device"}],"outcomes":[{"outcome_type":"primary","measure":"Adverse events (AEs)","time_frame":"Week 15 to Week 40","description":"Number and severity of adverse events"},{"outcome_type":"primary","measure":"Electrocardiogram (ECG)","time_frame":"Week 15 to Week 40","description":"Changes in electrical activity of heartbeat measured by electrocardiogram"},{"outcome_type":"primary","measure":"Beck Depression Inventory (BDI) score","time_frame":"Week 15 to Week 40","description":"Assessment of change in depression using Beck Depression Inventory (BDI) score"},{"outcome_type":"primary","measure":"Questionnaire for impulsive-compulsive disorder in Parkinson's disease rating scale (QUIP_RS)","time_frame":"Week 15 to Week 40","description":"Assessment of changes in impulsive-compulsive disorders using QUIP_RS"},{"outcome_type":"primary","measure":"Montreal cognitive assessment (MoCA)","time_frame":"Week 15 to Week 40","description":"Assessment of change in cognitive domains using MoCA test"},{"outcome_type":"primary","measure":"Physical examination","time_frame":"Week 15 to Week 40","description":"Changes in anatomic findings found in physical examination"},{"outcome_type":"primary","measure":"Vital signs","time_frame":"Week 15 to Week 40","description":"Changes in vital signs"},{"outcome_type":"primary","measure":"Clinical laboratory safety screen","time_frame":"Week 15 to Week 40","description":"Changes in clinical laboratory variables (chemistry, haematology, urinanalysis)"},{"outcome_type":"primary","measure":"Formation of anti-CDNF antibodies","time_frame":"Week 15 to Week 40","description":"Change in anti-CDNF antibody concentration"},{"outcome_type":"primary","measure":"Device related changes in safety measures","time_frame":"Week 8 to Week 40","description":"Occurrence of adverse device effects (ADE), for either the whole system or the individual sub systems (guide tubes/catheters, subcutaneous components, port), serious adverse device effect (SADE) including long term effects, neurological deficit (seizures), infection (local to components, in CNS), severe skin breakdown or necrosis requiring component removal life threatening or major (requiring intervention) intracerebral haemorrhage."},{"outcome_type":"primary","measure":"Device related accuracy of implantation","time_frame":"Week 8","description":"The accuracy of implantation of the Drug Delivery System (DDS) will be measured comparing the tip of each individual catheters defined in the plan of the surgical procedure with the position of those measured by the post-operative CT scan."},{"outcome_type":"secondary","measure":"UPDRS (Unified Parkinson's Disease Rating Scale) Part III motor score","time_frame":"Week 15 to Week 40","description":"Changes in severity of PD (Parkinson's disease) motor symptoms assessed by UPDRS Part III motor scores"},{"outcome_type":"secondary","measure":"TUG (Timed Up and Go) test","time_frame":"Week 15 to Week 40","description":"Changes in mobility assessed by TUG test"},{"outcome_type":"secondary","measure":"UPDRS Total score (Part I-IV)","time_frame":"Week 15 to Week 40","description":"Change in severity of PD non-motor and motor symptoms assessed by UPDRS Part I-IV total scores (Parts I, II and IV in ON-state; Part III in OFF-state)."},{"outcome_type":"secondary","measure":"Home diary score","time_frame":"Week 16 to Week 24","description":"Change in functional status assessed by home diary score"},{"outcome_type":"secondary","measure":"PDQ-39 (Parkinson's Disease Questionnaire) score","time_frame":"Week 15 to Week 40","description":"Changes in health and daily activity assessed by PDQ-39 questionnaire score"},{"outcome_type":"secondary","measure":"change in CGI (Clinical Global Impressions) scale","time_frame":"Week 16 to Week 40","description":"• Change from baseline until end of treatment evaluation in mental status as measured by CGI scale."},{"outcome_type":"secondary","measure":"Occurrence of blockage","time_frame":"Week 11 to Week 36","description":"Occurrence of blockage of implanted catheter preventing or limiting infusion assessed by measuring catheter pressure"},{"outcome_type":"secondary","measure":"Cessation of infusions","time_frame":"Week 11 to Week 36","description":"Cessation of infusions in an individual patient"},{"outcome_type":"other","measure":"DAT (dopamine transporter)-PET imaging","time_frame":"Week 14 to Week 38","description":"Change in caudate and putamen DAT availability using PET imaging."},{"outcome_type":"other","measure":"alpha-synuclein levels","time_frame":"Week 15 to Week 40","description":"Changes in serum and CSF (cerebrospinal fluid) concentrations of various α-synuclein species"},{"outcome_type":"other","measure":"Distribution of CDNF","time_frame":"Week 24 and Week 36","description":"Level of distribution of CDNF in serum and Cmax of CDNF in CSF"},{"outcome_type":"other","measure":"Daily activity measurement","time_frame":"Week 16 to Week 40","description":"Change in daily activity measured by Parkinson's KinetiGraph™ (PKG™) Data Logger"},{"outcome_type":"other","measure":"Coverage of infusate","time_frame":"Week 11 to Week 36","description":"Coverage of the infusate in target anatomy assessed by MRI (Magnetic resonance imaging)"}]}
{"nct_id":"NCT03280472","start_date":"2017-09-18","phase":"N/A","enrollment":60,"brief_title":"Transition to College/Miami University","official_title":"Transition to College/Miami University","primary_completion_date":"2019-01-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-01-31","last_update":"2017-12-19","description":"The current project will test whether a computerized training program, Cognitive Bias Modification (CBM), can be used as a prevention inoculation tool to reduce vulnerability to anxiety among incoming college students. Those not in the CBM condition will complete a symptom tracking condition (ST). We will also test whether ST influences vulnerability to anxiety among incoming college students.","other_id":"01368r","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  First and Second year students\r\n\r\n          -  Entered college in fall of 2017\r\n\r\n          -  Fluent in English\r\n\r\n          -  LSAS-SR score greater than or equal to 14 and less than or equal to 74.\r\n      ","sponsor":"Miami University","sponsor_type":"Other","conditions":"Interpretation Bias Modification|Symptom Tracking","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Cognitive Bias Modification","description":"CBM training. For those in the CBM condition, participants will complete a task. In this task, they will read ambiguous, two- to four-sentence social-related scenarios on the computer. The final word in the scenario will have a missing letter. Participants will type the missing letter. Participants will also be asked to answer a \"Yes/No\" comprehension question about the scenario. The missing letter will \"resolve\" the ambiguity of the scenario in a positive way, intended to train participants to have more positively-biased interpretations of ambiguous social information"},{"intervention_type":"Behavioral","name":"Behavioral: Symptom tracking","description":"Participants will track their symptoms"}],"outcomes":[{"outcome_type":"primary","measure":"Change in Student Adjustment to College Questionnaire","time_frame":"Participants report on their past few days. The SACQ is administered at T1-T5. T2 occurs within ~1 week of T1/baseline. T2-T5 are spaced ~1 week apart from each other. Sessions are ~60-90 minutes.","description":"Self-report on the degree to which the participant feels they are transitioning to college successfully."},{"outcome_type":"secondary","measure":"Change in Interpretations","time_frame":"Participants report interpretations to a variety of situations. The IQ is administered at T1 and T4. T2 occurs within 1 week of T1/baseline. T2-T5 are spaced ~1 week apart from each other. Sessions are ~60-90 minutes.","description":"A questionnaire assessing their interpretation of ambiguous, potentially anxiety-provoking situation"},{"outcome_type":"secondary","measure":"Change in Liebowitz Social Anxiety Scale-Self-Report","time_frame":"Participants report on symptoms during the past week. The LSAS-SR is administered at T1-T5. T2 occurs within ~1 week of T1/baseline. T2-T5 are spaced ~1 week apart from each other. Sessions are ~60-90 minutes.","description":"Self-report of social anxiety symptoms"}]}
{"nct_id":"NCT02957786","start_date":"2017-09-18","phase":"Phase 3","enrollment":679,"brief_title":"Cytisine Versus Varenicline for Smoking Cessation","official_title":"RAUORA: Cytisine Versus Varenicline for Smoking Cessation","primary_completion_date":"2019-10-10","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-10-10","last_update":"2021-08-19","description":"To evaluate the effectiveness, safety, and cost-effectiveness of cytisine plus behavioural support compared to varenicline plus behavioural support for smoking cessation, in indigenous Mori (or family of Mori) who smoke and are motivated to quit.","other_id":"UTN: U1111-1187-2838","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  daily tobacco smokers\r\n\r\n          -  self-identify as Mori (indigenous New Zealander) or whnau (family) of Mori\r\n\r\n          -  want to stop smoking in the next two weeks\r\n\r\n          -  are at least 18 years of age\r\n\r\n          -  are able to provide verbal consent\r\n\r\n          -  reside in the Lakes District Health Board, Eastern Bay of Plenty or Tokoroa region at\r\n             the time of enrolment\r\n\r\n          -  have daily access to a mobile phone with text capability and/or email and access to\r\n             the internet via computer or smartphone\r\n\r\n          -  are eligible for subsidised varenicline under special authority conditions\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  are pregnant or breastfeeding\r\n\r\n          -  are current users of other smoking cessation therapies (e.g. nicotine replacement\r\n             therapy [NRT], buproprion [Zyban], clonidine, nortriptyline, e-cigarettes)\r\n\r\n          -  are enrolled in another smoking cessation programme or another smoking cessation study\r\n\r\n          -  have a contraindication for cytisine or varenicline\r\n\r\n          -  have used varenicline or cytisine in the past 12 months\r\n\r\n          -  have another person in their household involved in the trial\r\n\r\n          -  have moderate or severe renal impairment,\r\n\r\n          -  are being treated for active or latent TB\r\n\r\n          -  have been treated for a heart attack, stroke, or severe angina within the last two\r\n             weeks\r\n\r\n          -  have uncontrolled high blood pressure (> 150 mmHg systolic, > 100 mmHg diastolic)\r\n\r\n          -  have a history of seizures\r\n      ","sponsor":"University of Auckland, New Zealand","sponsor_type":"Other","conditions":"Smoking Cessation","interventions":[{"intervention_type":"Drug","name":"Drug: Cytisine","description":"Cytisine tablets"},{"intervention_type":"Behavioral","name":"Behavioral: Behavioural support","description":"Withdrawal-orientated cessation support"},{"intervention_type":"Drug","name":"Drug: Varenicline","description":"Varenicline tablets"}],"outcomes":[{"outcome_type":"secondary","measure":"Medication compliance","time_frame":"Three months post-quit date","description":"Self-reported pill count, early stopping of allocated medication and reasons why."},{"outcome_type":"secondary","measure":"Adverse events","time_frame":"One month post-quit date","description":"Any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study treatment, whether or not it is considered related to the product."},{"outcome_type":"primary","measure":"Continuous abstinence from smoking","time_frame":"Six months post-quit date","description":"Self-report of smoking not more than five cigarettes from the quit date, supported by biochemical validation using a carbon monoxide (CO) expired breath"},{"outcome_type":"secondary","measure":"Continuous abstinence from smoking","time_frame":"One month post-quit date","description":"Self-report of smoking not more than five cigarettes from the quit date"},{"outcome_type":"secondary","measure":"Continuous abstinence from smoking","time_frame":"Three months post-quit date","description":"Self-report of smoking not more than five cigarettes from the quit date"},{"outcome_type":"secondary","measure":"Continuous abstinence from smoking","time_frame":"12 months post-quit date (in 2/3 of sample)","description":"Self-report of smoking not more than five cigarettes from the quit date, supported by biochemical validation using a carbon monoxide (CO) expired breath"},{"outcome_type":"secondary","measure":"7-day point prevalence abstinence from smoking","time_frame":"One month post-quit date","description":"Self-report of having smoked no cigarettes (not even a puff) in the past seven days."},{"outcome_type":"secondary","measure":"7-day point prevalence abstinence from smoking","time_frame":"Three month post-quit date","description":"Self-report of having smoked no cigarettes (not even a puff) in the past seven days."},{"outcome_type":"secondary","measure":"7-day point prevalence abstinence from smoking","time_frame":"Six month post-quit date","description":"Self-report of having smoked no cigarettes (not even a puff) in the past seven days,supported by biochemical validation using a carbon monoxide (CO) expired breath."},{"outcome_type":"secondary","measure":"7-day point prevalence abstinence from smoking","time_frame":"12 month post-quit date (in 2/3 of sample)","description":"Self-report of having smoked no cigarettes (not even a puff) in the past seven days,supported by biochemical validation using a carbon monoxide (CO) expired breath."},{"outcome_type":"secondary","measure":"Time to relapse back to smoking","time_frame":"One month post-quit date","description":"Defined as return to daily smoking."},{"outcome_type":"secondary","measure":"Time to relapse back to smoking","time_frame":"Three month post-quit date","description":"Defined as return to daily smoking."},{"outcome_type":"secondary","measure":"Time to relapse back to smoking","time_frame":"Six month post-quit date","description":"Defined as return to daily smoking."},{"outcome_type":"secondary","measure":"Time to relapse back to smoking","time_frame":"12 month post-quit date (in 2/3 of sample)","description":"Defined as return to daily smoking."},{"outcome_type":"secondary","measure":"Cigarette withdrawal","time_frame":"One month post-quit date","description":"The physical signs and symptoms associated with nicotine withdrawal over the last week, measured using the Mood and Physical Symptoms Scale (MPSS)"},{"outcome_type":"secondary","measure":"Cigarette withdrawal","time_frame":"Three months post-quit date","description":"The physical signs and symptoms associated with nicotine withdrawal over the last week, measured using the Mood and Physical Symptoms Scale (MPSS)"},{"outcome_type":"secondary","measure":"Cigarette withdrawal","time_frame":"Six months post-quit date","description":"The physical signs and symptoms associated with nicotine withdrawal over the last week, measured using the Mood and Physical Symptoms Scale (MPSS)"},{"outcome_type":"secondary","measure":"Cigarettes per day","time_frame":"One month post-quit date","description":"Number of cigarettes smoked per day, if smoking"},{"outcome_type":"secondary","measure":"Cigarettes per day","time_frame":"Three month post-quit date","description":"Number of cigarettes smoked per day, if smoking"},{"outcome_type":"secondary","measure":"Cigarettes per day","time_frame":"Six month post-quit date","description":"Number of cigarettes smoked per day, if smoking"},{"outcome_type":"secondary","measure":"Cigarettes per day","time_frame":"12 month post-quit date (in 2/3 of sample)","description":"Number of cigarettes smoked per day, if smoking"},{"outcome_type":"secondary","measure":"Smoking satisfaction, if smoking","time_frame":"One month post-quit date","description":"Measured using the modified Cigarette Evaluation Questionnaire (mCEQ)."},{"outcome_type":"secondary","measure":"Smoking satisfaction, if smoking","time_frame":"Three month post-quit date","description":"Measured using the modified Cigarette Evaluation Questionnaire (mCEQ)."},{"outcome_type":"secondary","measure":"Smoking satisfaction, if smoking","time_frame":"Six month post-quit date","description":"Measured using the modified Cigarette Evaluation Questionnaire (mCEQ)."},{"outcome_type":"secondary","measure":"Health-related quality of life","time_frame":"One month post-quit date","description":"Measured using the New Zealand EQ-5D Tariff 2"},{"outcome_type":"secondary","measure":"Health-related quality of life","time_frame":"Three months post-quit date","description":"Measured using the New Zealand EQ-5D Tariff 2"},{"outcome_type":"secondary","measure":"Health-related quality of life","time_frame":"Six months post-quit date","description":"Measured using the New Zealand EQ-5D Tariff 2"},{"outcome_type":"secondary","measure":"Acceptability of allocated treatment","time_frame":"One month post-quit date","description":"Participants will be asked for their views on the use of their allocated medication as a cessation aid (i.e. whether they would recommend the treatment to another smoker and the things they liked or disliked about using the product)."},{"outcome_type":"secondary","measure":"Acceptability of allocated treatment","time_frame":"Three months post-quit date","description":"Participants will be asked for their views on the use of their allocated medication as a cessation aid (i.e. whether they would recommend the treatment to another smoker and the things they liked or disliked about using the product)."},{"outcome_type":"secondary","measure":"Use of other methods of cessation","time_frame":"One month post-quit date","description":"Participants will be asked about their use of other methods of cessation, such as NRT, Zyban, clonidine, nortriptyline, e-cigarettes, acupuncture etc."},{"outcome_type":"secondary","measure":"Use of other methods of cessation","time_frame":"Three months post-quit date","description":"Participants will be asked about their use of other methods of cessation, such as NRT, Zyban, clonidine, nortriptyline, e-cigarettes, acupuncture etc."},{"outcome_type":"secondary","measure":"Use of other methods of cessation","time_frame":"Six months post-quit date","description":"Participants will be asked about their use of other methods of cessation, such as NRT, Zyban, clonidine, nortriptyline, e-cigarettes, acupuncture etc."},{"outcome_type":"secondary","measure":"Medication compliance","time_frame":"One month post-quit date","description":"Self-reported pill count, early stopping of allocated medication and reasons why."},{"outcome_type":"secondary","measure":"Adverse events","time_frame":"Three month post-quit date","description":"Any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study treatment, whether or not it is considered related to the product."},{"outcome_type":"secondary","measure":"Adverse events","time_frame":"Six month post-quit date","description":"Any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study treatment, whether or not it is considered related to the product."},{"outcome_type":"secondary","measure":"Adverse events","time_frame":"12 month post-quit date (in 2/3 of sample)","description":"Any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study treatment, whether or not it is considered related to the product."}]}
{"nct_id":"NCT03279081","start_date":"2017-09-15","phase":"Phase 3","enrollment":554,"brief_title":"Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Participants With Crohn's Disease (CD)","official_title":"A Phase-III, Randomized, Double-blind, Parallel-group, Placebo-controlled, International, Multicentre Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Patients With Crohn's Disease Over a Period of 24 Weeks and a Follow-up Period up to 52 Weeks","primary_completion_date":"2022-08-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-02-28","last_update":"2021-05-20","description":"The purpose of this study is to evaluate the combined remission of complex perianal fistulas, defined as the clinical assessment at Week 24 of closure of all treated external openings that were draining at baseline despite gentle finger compression, and absence of collections greater than (>) 2 centimeter (cm) (in at least 2 dimensions) confirmed by blinded central magnetic resonance imaging (MRI) assessment at Week 24.","other_id":"Cx601-0303","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Signed informed consent.\r\n\r\n          2. Participants of either gender greater than or equal to (>=) 18 years and less than or\r\n             equal to (<=) 75 years of age.\r\n\r\n          3. Participants with CD diagnosed at least 6 months prior to Screening visit in\r\n             accordance with accepted clinical, endoscopic, histological and/or radiological\r\n             criteria.\r\n\r\n          4. Presence of complex perianal fistula(s) with a maximum of 2 internal openings and a\r\n             maximum of 3 external openings based on clinical assessment; a central reading of a\r\n             locally performed contrast enhanced (gadolinium) pelvic MRI will be performed to\r\n             confirm location of the fistula and potential associated perianal abscess(es).\r\n             Fistula(s) must have been draining for at least 6 weeks prior to Screening visit.\r\n             Actively draining simple subcutaneous fistula(s), at the time of Screening visit, are\r\n             not allowed in this study. A complex perianal fistula is defined as a fistula that\r\n             meets one or more of the following criteria :\r\n\r\n               -  High inter-sphincteric, high trans-sphincteric, extra-sphincteric or\r\n                  suprasphincteric.\r\n\r\n               -  Presence of >=2 external openings.\r\n\r\n               -  Associated perianal abscess(es). Note: Abscesses that are larger than 2 cm at\r\n                  least 2 dimensions on MRI must be confirmed to have been drained adequately by\r\n                  the surgeon during the preparation curettage in order to be eligible.\r\n\r\n          5. Clinically controlled, nonactive or mildly active CD, during the last six months prior\r\n             to Screening visit with:\r\n\r\n               -  A patient reported outcomes (PRO-2) score <14 at Screening, AND\r\n\r\n               -  A colonoscopy documenting the absence of ulcers larger than 0.5 cm in the colonic\r\n                  mucosa:\r\n\r\n                  - If colonoscopy data are not available within 6 months prior to Screening:\r\n\r\n               -  A simple endoscopic score for Crohn's Disease (SES-CD) <=6 with absence of rectal\r\n                  ulcers larger than 0.5 cm must be documented in a colonoscopy performed at\r\n                  Screening before randomization.\r\n\r\n                  - If colonoscopy data are available within 6 months prior to Screening, the\r\n                  following must be documented, otherwise a new colonoscopy (as above) will be\r\n                  mandatory:\r\n\r\n               -  The absence of ulcers larger than 0.5 cm in the colonic mucosa AND\r\n\r\n               -  the improvement or no worsening in abdominal pain and/or in the diarrhea,\r\n                  sustained for one week or more, since the last colonoscopy was performed in the\r\n                  clinical records until Screening visit.\r\n\r\n             AND\r\n\r\n             o No hemoglobin decrease >=2.0 gram per deciliter (g/dL) or an unexplained rising\r\n             C-reactive protein (CRP), > 5.0 milligram per liter (mg/L) to a concentration above\r\n             the referenced upper limit of normal (ULN) (unless the rise is due to a known process\r\n             other than luminal Crohn's Disease), since the last colonoscopy was performed as\r\n             compared to results during the Screening visit.\r\n\r\n             AND\r\n\r\n             o no initiation or intensification of treatment with corticosteroids,\r\n             immunosuppressants or monoclonal antibodies (mAbs) dose regimen since the last\r\n             endoscopy up to Screening visit.\r\n\r\n          6. Participants whose perianal fistulas were previously treated and have shown an\r\n             inadequate response or a loss of response while they were receiving either an\r\n             immunosuppressive agent or tumour necrosis factor (TNF)-alpha antagonist or\r\n             vedolizumab or ustekinumab, or having documented intolerance to any of these\r\n             treatments administered at least at approved or recommended doses during the minimum\r\n             period mentioned:\r\n\r\n               -  Immunosuppressive agents: at least 3 months treatment with azathioprine (2-3\r\n                  milligram per kilogram per day [mg/kg/day]), 6-mercaptopurine (1-1.5 mg/kg/day),\r\n                  or subcutaneous/intramuscular methotrexate (25 mg/week) prior to Screening for\r\n                  the study.\r\n\r\n               -  TNFalpha antagonists:\r\n\r\n               -  Infliximab: at least 14 weeks treatment at the approved doses for induction\r\n                  and/or maintenance in Crohns disease prior to screening for the study. For\r\n                  induction: 1 intravenous dose of 5 milligram per kilogram (mg/kg) followed by the\r\n                  same dose 2 and 6 weeks after. For maintenance: 5-10 mg/kg intravenously every 8\r\n                  weeks, or more frequently.\r\n\r\n               -  Adalimumab: at least 14 weeks treatment at the approved doses for induction\r\n                  and/or maintenance in Crohn's disease prior to screening for the study. For\r\n                  induction: 1 subcutaneous dose of 160 milligram (mg), followed by 80 mg 2 weeks\r\n                  after. For maintenance: 40 mg subcutaneously every other week, or weekly.\r\n\r\n               -  Certolizumab l: at least 14 weeks treatment at the approved doses for induction\r\n                  and/or maintenance in Crohns disease prior to screening for the study. For\r\n                  induction: 1 subcutaneous dose of 400 mg, followed by the same dose 2 and 4 weeks\r\n                  after. For maintenance: 400 mg subcutaneously every 2 to 4 weeks.\r\n\r\n               -  Anti-integrin: at least 14 weeks treatment of the approved dose for induction\r\n                  and/or maintenance in Crohns disease prior to screening for the study. For\r\n                  induction: Vedolizumab 300 mg. For maintenance: Vedolizumab 300 mg every 4 to 8\r\n                  weeks.\r\n\r\n               -  Anti-interleukin (IL)-12/23: at least 16 weeks treatment of the approved dose in\r\n                  Crohns disease prior to screening for the study. For induction: Ustekinumab,\r\n                  approximately 6mg/kg intravenously initially then followed by 90 mg\r\n                  subcutaneously every 8 weeks.\r\n\r\n          7. Women of childbearing potential (WCBP) must have negative serum pregnancy test at\r\n             screening (sensitive to 25 international units [IU] human chorionic gonadotropin\r\n             [hCG]). Both WCBP or male participants participating in this study, with a WCBP as\r\n             partner, must agree to use an adequate method of contraception during the entire\r\n             duration of the study. An adequate method of contraception is defined as complete,\r\n             non-periodic sexual abstinence (refraining from heterosexual intercourse),\r\n             single-barrier method, vasectomy, adequate hormonal contraception (to have started at\r\n             least 7 days prior to Screening visit), or an intra-uterine device (to have been in\r\n             place for at least 2 months prior to Screening visit).\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Concomitant rectovaginal or rectovesical fistula(s).\r\n\r\n          2. Participant nave to prior specific medical treatment for complex perianal fistula(s)\r\n             including immunosuppressant (IS) or anti-TNFs.\r\n\r\n          3. Presence of a perianal collection >2 cm in at least two dimensions on the central\r\n             reading MRI at Screening visit that was not adequately drained as confirmed by the\r\n             surgeon during the preparation procedure (week -3 to day 0).\r\n\r\n          4. Severe rectal and/or anal stenosis and/or severe proctitis (defined as the presence of\r\n             large >0.5 cm ulcers in the rectum) that make impossible to follow the surgery\r\n             procedure manual.\r\n\r\n          5. Participant with diverting stomas.\r\n\r\n          6. Active, uncontrolled infection requiring parenteral antibiotics.\r\n\r\n          7. Participant with ongoing systemic or rectal steroids for CD in the last 2 weeks prior\r\n             to the Preparation visit.\r\n\r\n          8. Participants with major alteration on any of the following laboratory tests or\r\n             increased risk for the surgical procedure:\r\n\r\n               -  Serum creatinine levels >1.5 times the ULN\r\n\r\n               -  Total bilirubin >1.5 ULN\r\n\r\n               -  Aspartate Transaminase (AST)/ Alanine Transaminase (ALT) >3 times ULN\r\n\r\n               -  Hemoglobin <10.0 g/dL\r\n\r\n               -  Platelets <75.0*10^9/L\r\n\r\n               -  Albuminemia <3.0 g/dL\r\n\r\n          9. Suspected or documented infectious enterocolitis within two weeks prior to Screening\r\n             visit.\r\n\r\n         10. Any prior invasive malignancy diagnosed within the last 5 years prior to Screening\r\n             visit. Participants with basal-cell carcinoma of the skin completely resected outside\r\n             the perineal region can be included.\r\n\r\n         11. Current or recent (within 6 months prior to the Screening visit) history of severe,\r\n             progressive, and/or uncontrolled hepatic, haematological, gastrointestinal (GI) (other\r\n             than CD), renal, endocrine, pulmonary, cardiac, neurological or psychiatric disease\r\n             that may result in participants increased risk from study participation and/or lack of\r\n             compliance with study procedures.\r\n\r\n         12. Participants with primary sclerosing cholangitis.\r\n\r\n         13. Participants with known chronically active hepatopathy of any origin, including\r\n             cirrhosis and participants with persistent positive Hepatitis B Virus (HBV) surface\r\n             antigen (HBsAg) and quantitative HBV polymerase chain reaction (PCR), or positive\r\n             serology for Hepatitis C Virus (HCV) and quantitative HCV PCR within 6 months prior to\r\n             Screening.\r\n\r\n         14. Congenital or acquired immunodeficiencies, including participants known to be HIV\r\n             carriers\r\n\r\n         15. Known allergies or hypersensitivity to penicillin or aminoglycosides; Dulbecco\r\n             Modified Eagle's Medium (DMEM); bovine serum; local anaesthetics or gadolinium (MRI\r\n             contrast).\r\n\r\n         16. Contraindication to MRI scan (example, due to the presence of pacemakers, hip\r\n             replacements or severe claustrophobia).\r\n\r\n         17. Severe trauma within 6 months prior to Screening visit.\r\n\r\n         18. Pregnant or breastfeeding women.\r\n\r\n         19. Participants who do not wish to or cannot comply with study procedures.\r\n\r\n         20. Participants currently receiving, or having received any investigational drug within 3\r\n             months prior to Screening visit.\r\n\r\n         21. Participants previously treated with Cx601 or other allogeneic stem-cell therapy\r\n             cannot be enrolled into this clinical study.\r\n\r\n         22. Any major surgery of the GI tract (including one or more segments of the colon or\r\n             terminal ileum) within 6 months prior the screening or any minor surgery of the GI\r\n             tract within 3 months prior to screening.\r\n\r\n         23. Participants who had local perianal surgery other than drainage for the fistula within\r\n             6 months prior to the Screening visit, or those who may need surgery in the perianal\r\n             region for reasons other than fistulas at the time of inclusion in the study.\r\n\r\n         24. Contraindication to the anaesthetic procedure.\r\n      ","sponsor":"Tigenix S.A.U.","sponsor_type":"Industry","conditions":"Crohn's Disease","interventions":[{"intervention_type":"Drug","name":"Drug: Cx601","description":"Cx601 eASCs intralesional injection."},{"intervention_type":"Other","name":"Other: Placebo","description":"Cx601 placebo-matching eASCs intralesional injection."}],"outcomes":[{"outcome_type":"secondary","measure":"Number of Participants With TEAEs Related to Vital Sign Parameters","time_frame":"Week 24 and Week 52"},{"outcome_type":"secondary","measure":"Number of Participants With TEAEs Related to Clinical Laboratory Parameters","time_frame":"Week 24 and Week 52"},{"outcome_type":"primary","measure":"Percentage of Participants with Combined Remission at Week 24","time_frame":"Week 24","description":"Combined Remission is defined as the closure of all treated external openings that were draining at baseline despite gentle finger compression and absence of collection(s) >2 cm (in at least 2 dimensions) of the treated perianal fistula(s) confirmed by blinded central MRI assessment."},{"outcome_type":"secondary","measure":"Percentage of Participants with Clinical Remission at Week 24","time_frame":"Week 24","description":"Clinical remission is defined as closure of all treated external openings that were draining at baseline despite gentle finger compression."},{"outcome_type":"secondary","measure":"Time to Clinical Remission up to Week 24","time_frame":"From the treatment start to first visit with closure of all treated external openings that were draining at baseline despite gentle finger compression, as clinically assessed (up to Week 24)","description":"Time to clinical remission is defined as the time from treatment start to first visit with closure of all treated external openings that were draining at baseline despite gentle finger compression, as clinically assessed."},{"outcome_type":"secondary","measure":"Percentage of Participants with Clinical Response at Week 24","time_frame":"Week 24","description":"Clinical response is defined as closure of at least 50 percent (%) of all treated external openings that were draining at baseline despite gentle finger compression."},{"outcome_type":"secondary","measure":"Time to Clinical Response up to Week 24","time_frame":"From treatment start to first visit with closure of at least 50% of all treated external openings that were draining at baseline, despite gentle finger compression, as clinically assessed (up to Week 24)","description":"Time to clinical response is defined as the time from treatment start to first visit with closure of at least 50% of all treated external openings that were draining at baseline, despite gentle finger compression, as clinically assessed."},{"outcome_type":"secondary","measure":"Percentage of Participants with Combined Remission at Week 52","time_frame":"Week 52","description":"Combined Remission is defined as the closure of all treated external openings that were draining at baseline despite gentle finger compression, and absence of collections >2 cm (in at least 2 dimensions) confirmed by blinded central MRI assessment."},{"outcome_type":"secondary","measure":"Percentage of Participants with Clinical Remission at Week 52","time_frame":"Week 52","description":"Clinical remission is defined as closure of all treated external openings that were draining at baseline despite gentle finger compression."},{"outcome_type":"secondary","measure":"Percentage of Participants with Clinical Response at Week 52","time_frame":"Week 52","description":"Clinical response is defined as closure of at least 50% of all treated external openings that were draining at baseline, despite gentle finger compression."},{"outcome_type":"secondary","measure":"Time to Clinical Remission up to Week 52","time_frame":"From treatment start to first visit with closure of all treated external openings that were draining at baseline despite gentle finger compression, as clinically assessed (up to Week 52)","description":"Time to clinical remission is defined as the time from treatment start to first visit with closure of all treated external openings that were draining at baseline despite gentle finger compression, as clinically assessed."},{"outcome_type":"secondary","measure":"Time to Clinical Response up to Week 52","time_frame":"From treatment start to first visit with closure of at least 50% of all treated external openings that were draining at baseline despite gentle finger compression, as clinically assessed (up to Week 52)","description":"Time to clinical response is defined as time from treatment start to first visit with closure of at least 50% of all treated external openings that were draining at baseline despite gentle finger compression, as clinically assessed."},{"outcome_type":"secondary","measure":"Percentage of Participants with Relapse from Week 24 Combined Remission","time_frame":"Week 24","description":"Relapse is defined as reopening of any of the treated fistulas external openings with active drainage as clinically assessed, or the development of a perianal fluid collection >2 cm of the treated perianal fistula confirmed by centrally read MRI assessment in participants who were in combined remission at week 24."},{"outcome_type":"secondary","measure":"Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs)","time_frame":"Week 24 and Week 52"}]}
{"nct_id":"NCT03309904","start_date":"2017-09-15","phase":"N/A","enrollment":910,"brief_title":"Sport Without Injury ProgrammE Floorball","official_title":"Sport Without Injury ProgrammE Floorball","primary_completion_date":"2018-04-15","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-05-31","last_update":"2018-08-21","description":"This study evaluates the preventive effect of a neuromuscular training program on injuries in youth floorball players. Half of participants will receive the training program, and half act as control and perform their usual training practices.","other_id":"MHgglund SWIPE Floorball","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","intervention_model_description":"Parallell group cluster-randomized trial","sampling_method":"","gender":"All","minimum_age":12,"maximum_age":17,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Teams with players 12-17 years of age (born 2000-2005)\r\n\r\n          -  Teams who have not used a structured training program aiming to prevent injuries (the\r\n             Knee Control or similar program) on a regular basis the last year\r\n\r\n          -  Teams who have training at least twice per week\r\n\r\n        Exclusion Criteria:\r\n\r\n        -\r\n      ","sponsor":"Linkoeping University","sponsor_type":"Other","conditions":"Athletic Injuries","interventions":[{"intervention_type":"Other","name":"Other: Knee Control training program","description":"10-minute training program to be performed at all team training sessions during the season."}],"outcomes":[{"outcome_type":"primary","measure":"All physical complaints injury","time_frame":"Study start up to end of season (6 months)","description":"Any floorball related injury regardless of need of care or absence from floorball training or matches (\"all physical complaints\" injury definition)"},{"outcome_type":"secondary","measure":"Time-loss injury","time_frame":"Study start up to end of season (6 months)","description":"Floorball related injury causing absence from the next training or match with the team (\"time-loss injury\")"},{"outcome_type":"secondary","measure":"Medical attention injury","time_frame":"Study start up to end of season (6 months)","description":"Floorball related injury requiring the player to seek care (\"medical attention injury\")"},{"outcome_type":"secondary","measure":"Adverse events","time_frame":"Study start up to end of season (6 months)","description":"Adverse events of using the program (intervention group only)"},{"outcome_type":"secondary","measure":"Intervention compliance and fidelity","time_frame":"Study start up to end of season (6 months)","description":"Coach reported compliance and fidelity with the program protocol (intervention group only)"},{"outcome_type":"secondary","measure":"Coach experience of injuries and intervention program","time_frame":"Baseline and 6 months","description":"Coach baseline and follow-up experiences of injuries (control group and intervention group) and of the Knee Control program (intervention group only)"},{"outcome_type":"secondary","measure":"Player experience of injuries and intervention program","time_frame":"Baseline and 6 months","description":"Player baseline and follow-up experiences of injuries (control group and intervention group) and of the Knee Control program (intervention group only)"},{"outcome_type":"secondary","measure":"Exercise fidelity","time_frame":"At approximately 2 months and 5 months","description":"Exercise fidelity (observation of the technique when using the intervention in select intervention group teams)"},{"outcome_type":"secondary","measure":"Health care need","time_frame":"After study end at 6 months","description":"Number of health care visits due to floorball related injuries during the season, type of diagnostic examinations and treatments"},{"outcome_type":"secondary","measure":"Costs","time_frame":"After study end at 6 months","description":"Estimated costs of floorball related injuries and costs of the intervention"}]}
{"nct_id":"NCT03686722","start_date":"2017-09-09","phase":"Phase 1","enrollment":20,"brief_title":"Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin","official_title":"Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetics and Pharmacodynamics of Metformin","primary_completion_date":"2017-10-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-12-06","last_update":"2018-10-12","description":"A Randomized,Two-period, Crossover Study to Determine the Possibility of Drug-drug Interaction After Co-administration of Metformin and Daclatasvir Where Twenty Eligible Adult Subjects Will be Randomized to Receive Either Metformin Only and/or Metformin Co-administered With Daclatasvir to measure primary outcomes including pharmacokinetics parameters as: Maximum drug concentration in plasma(Cmax), Area under the Plasma concentration Versus Time Curve from time 0 to 12 hours(AUC0-12), Clearance(CL)","other_id":"MET-DAC\\DDIS\\01217","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Other","masking_description":"Double","intervention_model_description":"Twenty Eligible Adult Subjects Will be Randomized Equally into two Groups: A and B To Receive Either:\r\nGroup (A):10 subjects will receive 500 mg Metformin twice daily on day 1-4 then 1000mg metformin twice on day 5-7 Group (B):10 subjects will receive 500 mg co-administered daily with Daclatasvir 60 mg once daily on day 1-4 then 1000mg Metformin co-administered twice daily with Daclatasvir 60 mg once daily on day 5-7","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Subject is at least 18-55 years at screening.\r\n\r\n          2. Subject has a Body Mass Index of 18 to 35 kg/m2.\r\n\r\n          3. Subject are non smokers or moderate smokers(not more than 10 cigarettes per day)\r\n\r\n          4. Subjects is willing to participate and give their final written consent prior to the\r\n             commencement of the study procedures\r\n\r\n          5. Subject is in good age-appropriate health condition as established by medical history,\r\n             physical examination, and results of biochemistry, hematology and urine analysis\r\n             testing within 4 weeks prior to study.\r\n\r\n          6. Subject has a normal blood pressure and pulse rate, according to the reference normal\r\n             ranges.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Treatment with any known enzyme-inducing/inhibiting agents prior to the start of the\r\n             study and throughout the study.\r\n\r\n          2. Subjects who have taken any medication two weeks preceding of the trial starting date.\r\n\r\n          3. Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.\r\n\r\n          4. Any prior surgery of the gastrointestinal tract that may interfere with drug\r\n             absorption.\r\n\r\n          5. Gastrointestinal diseases.\r\n\r\n          6. Renal diseases.\r\n\r\n          7. Cardiovascular diseases specially transient ischemic attacks and cardiac dysrhythmia .\r\n\r\n          8. Pancreatic disease including diabetes.\r\n\r\n          9. Hepatic diseases as hepatic failure, cirrhosis, galactose intolerance, fructose\r\n             intolerance, glycogen storage diseases\r\n\r\n         10. Hematological disease or pulmonary disease\r\n\r\n         11. Abnormal laboratory values.\r\n\r\n         12. Subjects who have donated blood or who have been involved in a drug study within 6\r\n             weeks preceding the start of the study.\r\n\r\n         13. Positive HIV test.\r\n\r\n         14. History of or current abuse of drugs, alcohol or solvents.\r\n\r\n         15. Endocrine disorders as Pheochromocytoma, Addison disease, glucagon deficiency,\r\n             carcinomas, extrahepatic tumors\r\n\r\n         16. Autoimmune disorders as Graves disease\r\n\r\n         17. Central nervous system (CNS) disorders\r\n      ","sponsor":"Mohamed Raslan","sponsor_type":"Other","conditions":"Diabetes Mellitus, Type 2|Hepatitis C|Drug Interactions","interventions":[{"intervention_type":"Drug","name":"Drug: Metformin","description":"Metformin is used primarly in treatment of diabetes type II"},{"intervention_type":"Drug","name":"Drug: Daclatasvir","description":"Daclatsvir is a direct acting antiviral drug"}],"outcomes":[{"outcome_type":"primary","measure":"Mean residence time of drug(MRT)","time_frame":"From first sampling interval up to 12 hours","description":"Mean residence time of drug in plasma measured in (hr)"},{"outcome_type":"primary","measure":"steady state Clearance of drug(CLss)","time_frame":"From first sampling interval up to 12 hours","description":"steady state Clearance of drug measured in (ml/min)"},{"outcome_type":"primary","measure":"Renal Clearance of drug(CLr)","time_frame":"From first sampling interval up to 12 hours","description":"Renal Clearance of drug measured in (ml/min)"},{"outcome_type":"primary","measure":"Cumulative amount of drug eliminated in urine (Ae)","time_frame":"From first sampling interval up to 12 hours","description":"Cumulative amount of drug eliminated in urine measured in (microgram(ug)/ml)"},{"outcome_type":"primary","measure":"(AUC0→12)","time_frame":"From first sampling interval(time zero) up to 12 hours","description":"Area under the plasma concentration-time curve measured in (nanogram(ng).hr/ml)"},{"outcome_type":"primary","measure":"Area under the plasma concentration-time curve from time 0 to infinity (AUC0→∞)","time_frame":"From first sampling interval up to infinity","description":"Area under the plasma concentration-time curve from time 0 to infinity measured in(ng.hr/ml)"},{"outcome_type":"primary","measure":"Area under the plasma concentration-time curve from time 0 to tau(AUC0→tau)","time_frame":"From first sampling interval up to dosing interval(Tau)","description":"Area under the plasma concentration-time curve from time 0 to tau measured in(ng.hr/ml)"},{"outcome_type":"primary","measure":"Maximum drug concentration in plasma at steady state(Cpss)","time_frame":"Time corresponding to maximum drug concentration in plasma at steady state","description":"Maximum drug concentration in plasma at steady state measured in (ng/ml)"},{"outcome_type":"primary","measure":"Half life( t½) of drug in plasma","time_frame":"Up to 12 hours","description":"Half life of drug measured in Hours(hr)"},{"outcome_type":"primary","measure":"Maximum excretion rate (Urate max)","time_frame":"From first sampling interval up to 12 hours","description":"Maximum excretion rate for the drug measured in (milligram(mg)/hr)"},{"outcome_type":"secondary","measure":"Blood Glucose(BG) levels","time_frame":"up to 3 hours","description":"Blood glucose levels measured in (mg/dl)"},{"outcome_type":"secondary","measure":"Area under the BG-time curve(AUG)0-3hr","time_frame":"up to 3 hours","description":"Area under the BG-time curve measured in (mg.hr/dl)"},{"outcome_type":"secondary","measure":"Maximum Glucose concentration(Gmax)","time_frame":"up to 3 hours","description":"Maximum Glucose concentration measured in (mg/dl)"}]}
{"nct_id":"NCT03288688","start_date":"2017-09-08","phase":"N/A","enrollment":30,"brief_title":"Effect of an Exercise Program Designed for Orchestral Musicians","official_title":"Effect of an Exercise Program Designed for Professional Orchestral Musicians on Performance-related Musculoskeletal Problems - a Randomized Controlled Trial","primary_completion_date":"2017-11-17","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-11-17","last_update":"2018-06-12","description":"This study is a randomized clinical trial evaluating the effect of an exercise program designed specifically for orchestral musicians on performance-related musculoskeletal problems (PRMPs). Professional and conservatory-level orchestral musicians will be recruited. Half of the subjects will participate in an 11-week home exercise program and attend three group exercise sessions and an educational presentation on injury prevention, while the other half of the subjects will receive no intervention, and continue their usual activities.","other_id":"Orch musicians","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  professional or freelance orchestral musician, or tertiary-level full-time music\r\n             student majoring in an orchestral instrument\r\n\r\n          -  able to commit to performing exercises 2 times per week over an 11-week period\r\n\r\n          -  medical condition permitting participation in an exercise program (ie. no serious\r\n             heart or lung condition that may be exacerbated by physical exertion)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  presence of musculoskeletal injuries definitively non-related to musical practice or\r\n             performance\r\n\r\n          -  fewer than 15 hours per week playing their instrument\r\n\r\n          -  corticosteroid infiltration in the 6 weeks preceding recruitment\r\n\r\n          -  prescribed anti-inflammatory drugs or neurontin in the 3 weeks preceding recruitment\r\n      ","sponsor":"Laval University","sponsor_type":"Other","conditions":"Musculoskeletal Disorder","interventions":[{"intervention_type":"Other","name":"Other: Exercise program and education","description":"The exercise program comprises warm-ups, exercises and cool-downs and aims to improve recruitment, strength and endurance of postural muscle groups that are key to the work of a musician. Basic activation exercises progress to dynamic and resisted exercises as well as functional musical movements. There is a series of six exercises of increasing difficulty for each of the following bodily regions: hips, back, neck, shoulders and abdominals.\r\nTopics to be discussed in the educational presentation and e-mails include healthy practice habits, activity dosage, the importance of physical activity, how the body adapts to workload and physical stressors, and instructions pertaining to the exercise program."}],"outcomes":[{"outcome_type":"primary","measure":"The Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians (MPIIQM)","time_frame":"Baseline-11 weeks","description":"A biopsychosocial self-report questionnaire used to obtain demographic and occupational information and to document the intensity and impact of performance-related musculoskeletal pain/problems"},{"outcome_type":"secondary","measure":"The Nordic Musculoskeletal Questionnaire (NMQ)","time_frame":"Baseline-11 weeks","description":"Self-report questionnaire on pain/symptom prevalence in the different regions of the body"},{"outcome_type":"secondary","measure":"Global Rating of Change","time_frame":"11 weeks","description":"Questionnaire designed to quantify participants' perceived improvement or deterioration over the course of the study"}]}
{"nct_id":"NCT03042728","start_date":"2017-09-07","phase":"N/A","enrollment":229,"brief_title":"Impact of Inclusion of a Therapy Dog Visit as Part of the Fibromyalgia Treatment Program","official_title":"Impact of Inclusion of a Dog as Part of the Fibromyalgia Treatment Program on Patient's Physical and Mental Health Functioning - A Randomized Controlled Trial","primary_completion_date":"2018-10-20","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-10-20","last_update":"2019-01-02","description":"In this study the investigators hypothesize that the presence of a Mayo Clinic certified therapy dog will provide additional benefits above typical therapy for patients suffering from fibromyalgia currently enrolled in the Mayo Clinic Fibromyalgia Program.","other_id":"16-006296","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion criteria:\r\n\r\n          -  Patients diagnosed with Fibromyalgia at our Fibromyalgia Clinic\r\n\r\n          -  Patients actively being seen at the Fibromyalgia Clinic\r\n\r\n          -  Able and willing to give informed consent\r\n\r\n          -  Able to speak English\r\n\r\n          -  Able to complete questionnaires\r\n\r\n          -  No fear or allergy of dogs\r\n\r\n        Exclusion Criteria\r\n\r\n          -  Diagnoses of bipolar disorder, schizophrenia, or dementia\r\n\r\n          -  Individuals who decline to participate in the study\r\n\r\n          -  Individuals that are severely allergic to or fearful of dogs\r\n      ","sponsor":"Mayo Clinic","sponsor_type":"Other","conditions":"Fibromyalgia","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Dog Interaction","description":"A therapy dog will visit the patients."},{"intervention_type":"Behavioral","name":"Behavioral: Human Interaction","description":"A human will visit the patients."}],"outcomes":[{"outcome_type":"primary","measure":"Change in Revised Fibromyalgia Impact Questionnaire (FIQR) score","time_frame":"Baseline to 1.5 day","description":"The FIQR questionnaire consists of 21 questions in 3 domains. Each question has 11 boxes similar to a visual analog scale, rating the item from no difficulty to very difficult. To score the FIQR, the researcher must sum the answers for each domain. Then the function domain is divided by 3, the overall impact domain remains unchanged, and the symptom domain score is divided by 2. The resulting scores are added, and final score can range from 0 -100, with 0=no difficulty, and 100=great difficulty."},{"outcome_type":"secondary","measure":"Change in Pain Intensity Score (Numeric Rating Scale (NRS))","time_frame":"Baseline to 1.5 day","description":"The subject is asked to make three pain ratings corresponding to the current, best, and worst pain experienced over the past 24 hours. The average of the 3 ratings is used to represent the patient's level of pain over the previous 24 hours. The NRS scale consists of numbers 0 through 10, with 0=no pain, 1-3=mild pain, 4-6=moderate pain, and 7-10=severe pain."},{"outcome_type":"secondary","measure":"Change in Score for Fatigue, Anxiety, and Depression","time_frame":"Baseline to 1.5 day","description":"The subject is asked to rate their symptoms on a visual analog scale from 1-10, with 1=not at all, and 10=unbearable."}]}
{"nct_id":"NCT03176030","start_date":"2017-09-01","enrollment":0,"brief_title":"Fortified Foods in Older Inpatients","official_title":"Can Fortified Foods Improve Energy and Protein Intake in Older People Whilst in Hospital? A Pilot Study","primary_completion_date":"2018-03-31","study_type":"Observational","rec_status":"Withdrawn","completion_date":"2018-03-31","last_update":"2018-09-07","description":"Malnutrition in older inpatients is a significant problem espicially among those with dementia. A number of methods have been used to tackle this issue and oral nutritional supplements (ONS) were proven to be the most effective way. However, they are limited by their poor tolerability due to lack of familiarity with these products. An alternative method is to fortify familiar food with protein, energy and micronutrient. thus, the aim of this study to test the feasibility and acceptability of delivering fortified foods to older patients whilst in hospital including those with dementia and frailty. This pilot study will compare the daily protein and energy intake in older people before and after offering fortified food. Furthermore, patients' likeability and staff acceptability of these fortified foods will be assessed.","other_id":"RHM MED1428","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":70,"maximum_age":100,"population":"Eligible patients will be female and male older patients who are admitted to acute medical\r\n        wards for older people in two hospitals.","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Both female and male participants in each hospital.\r\n\r\n          2. Patients aged 70 years and above including those who have dementia and frailty.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients receiving enteral tube feeding or parenteral nutrition\r\n\r\n          2. Patients with a known food allergy, eating disorder or illness, which requires a\r\n             therapeutic diet incompatible with fortification.\r\n\r\n          3. Patients who are receiving end of life care.\r\n      ","sponsor":"University Hospital Southampton NHS Foundation Trust","sponsor_type":"Other","conditions":"Malnutrition|Dementia|Aging|Frail Elderly Syndrome","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Fortified Foods","description":"The intervention under study is the provision of between-meal fortified foods (enhanced with protein, energy, and micronutrients) and meal supplementation where meals are poorly consumed. Foods will include both savory and sweet foods with different flavors. Foods will be matched as closely as possible in protein and energy and are calculated to provide typically 210 kcal and 5g protein per item. The volume / weight of the foods are standardized to be of relatively small portion size, such as 100 ml for ice-creams, 40 g for cakes and biscuits, and 100 ml for soup. Some of the products will be supplemented with micronutrients particularly needed by older adults, such as Vitamins (C, D, folic acid, B2, B6) and calcium at one third of the Dietary Reference Values (DRV) per portion. The aim is to achieve a daily consumption of two additional fortified food items."}],"outcomes":[{"outcome_type":"primary","measure":"Daily energy and protein intake","time_frame":"3 consecutive months","description":"Daily dietary intake will be assessed on three days during both the baseline and intervention periods using visual assessment. each food or meal will be weighed before serving and once the patient has finished using calibrated scales. In addition, a photograph of each plate of food will be taken before and after consumption for each eligible patient. At the end of each meal, the proportion of uneaten (leftover) food will be recorded in quartiles (0%, 25%, 50%, 75%, or 100%) for each component"},{"outcome_type":"primary","measure":"Feasibility of delivering fortified foods","time_frame":"3 days intervention period","description":"The number, type, and frequency of fortified foods chosen by eligible patients during the intervention period will be recorded. This will be done by using a food chart with images. Thus data will be collected on the type of foods (ice-creams, biscuits, soups or cakes) chosen, flavors preferred by individual patients initially and repeat choices, the number of foods chosen each time and at which time of the day."},{"outcome_type":"primary","measure":"Patient's likeability of fortified foods","time_frame":"3 days intervention period","description":"A 9-point likeability scale will be completed for each eligible patient to test likeability of fortified foods after each meal or snack time during the intervention period."},{"outcome_type":"secondary","measure":"Acceptability of fortified food","time_frame":"within 4 weeks of completing the intervention","description":"A purposive sample staff (nursing staff, catering staff and volunteers) involved in the delivery of fortified foods from the study wards in both hospitals will be invited to take part in interviews or focus groups. Participants will be recruited until theoretical saturation has been met; a total sample of approximately 15-20 staff members across the two settings is anticipated to be adequate."}]}
{"nct_id":"NCT02841683","start_date":"2017-09-01","phase":"N/A","enrollment":2806,"brief_title":"Pragmatic Randomised Controlled Trial Evaluating Effectiveness of a Smoking Cessation e- Intervention \" Tabac Info Service \"","official_title":"Evaluation of Effectiveness of Tabac Info Service (EE-TIS)","primary_completion_date":"2019-03-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-09-01","last_update":"2020-08-24","description":"Introduction - A national smoking cessation E-intervention, called Tabac Info Service (TIS), was developed in France to provide an adapted web and mobile application support to smoking cessation for all adults smokers, with or without chronic diseases, who want to stop smoking. This paper presents the study protocol of the evaluation of the program. The primary objective of this evaluation is to assess the efficacy and efficacy conditions of eTIS. The secondary objectives are to 1) describe efficacy variations in regard to user characteristics, 2) analyze mechanisms and efficacy conditions of eTIS, through variations of use, social or environmental contextual factors likely to influence the efficacy of eTIS, and the behavior change techniques (BCTs). Methods and analyses - The study design is a two-arm pragmatic randomized controlled trial including a process evaluation with at least 3000 participants randomized to the intervention or to the control arm (current practices presented in a non-interactive website). Inclusion criteria are: Adults, Smokers with an information and consent form completed, Getting a smartphone and using mobile applications, wanting stop to smoking in short, medium or long terms. The exclusion criterion is the refusal to participate in the study. The primary outcome is the point prevalence abstinence of 7 days at 6 months later. The secondary outcomes are: the point prevalence abstinence of 24 h at 3 months later, the point prevalence abstinence of 30 days at 12 months later, number of quit attempts during the study, progression of stages within the program (changes and duration in each stage). Data will be analyzed in Intention to treat (main analyze) and per protocol ways. A logistic regression will be carried out to estimate an OR [95% confidence interval] for efficacy. A multivariate multilevel analysis will explore the influence of patients' characteristics, social and environmental context, conditions of use and behavior change techniques on results. Dissemination -The findings of this study will allow us to understand and characterize the efficacy of eTIS, and conditions of its efficacy, underlining psychological, sociological, environmental and contextual factors, which could influence the efficacy of this type of intervention on smokers. These findings will be disseminated through peer-reviewed journals, national and international conference presentations and public events.","other_id":"Cnamts_2016_1","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  adult smokers\r\n\r\n          -  with an information and consent form completed\r\n\r\n          -  agreed to participate in the study\r\n\r\n          -  get a Smartphone and be willing to use applications\r\n\r\n          -  wanting stop smoking (in short, medium or long terms).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  refusal to participate in the study\r\n      ","sponsor":"Ecole des Hautes Etudes en Sant Publique","sponsor_type":"Other","conditions":"Tobacco Smoking","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Tabac Info Service","description":"A smoking cessation E-intervention, Tabac Info Service (TIS), by website and mobile application"}],"outcomes":[{"outcome_type":"primary","measure":"Point prevalence abstinence of 7 days","time_frame":"6 months"},{"outcome_type":"secondary","measure":"continuous abstinence rate","time_frame":"6 months","description":"Defined as the proportion of participants remaining continuously abstinent from the cessation date to the endpoint"},{"outcome_type":"secondary","measure":"continuous abstinence rate","time_frame":"12 months","description":"Defined as the proportion of participants remaining continuously abstinent from the cessation date to the endpoint"},{"outcome_type":"secondary","measure":"minimum 24-hour point abstinence","time_frame":"3 months"},{"outcome_type":"secondary","measure":"minimum 30-day point abstinence","time_frame":"12 months"},{"outcome_type":"secondary","measure":"number of quit attempts","time_frame":"6 months"},{"outcome_type":"secondary","measure":"total duration of quit attempts","time_frame":"6 months","description":"calculated as sum of days with no use"}]}
{"nct_id":"NCT03095742","start_date":"2017-09-01","phase":"N/A","enrollment":60,"brief_title":"Bedside Monitoring of Cerebral Energy State During the Peri-cardiac Arrest Period","official_title":"Bedside Monitoring of Cerebral Energy State During the Peri-cardiac Arrest Period - Blood Pressure Targets in Post Resuscitation Care","primary_completion_date":"2020-09-03","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-09-03","last_update":"2021-06-01","description":"In comatose patients resuscitated from out of hospital cardiac arrest (OHCA), neurological injuries remain the leading cause of death. The in-hospital mortality is reported at 30-50%, and the total mortality, although improved substantially over the last decade, remain to be significant, in most countries at up to 90%. An adequate blood pressure must be maintained in the post-cardiac arrest patient and helps to avoid further brain injury. The current trial addresses strategies for neuroprotection using a design of two different target blood pressure levels. \"Normal MAP\" (approximately 65 mmHg) vs. \"high MAP\" (approximately 75 mmHg). Markers measuring global cerebral ischemia caused by cardiac arrest and consecutive resuscitation, and reflecting the metabolic changes after successful resuscitation are urgently needed to enable a more personalized resuscitation and post resuscitation care. It is technically simple and feasible to place a microdialysis catheter in the jugular bulb and monitor biochemical variables related to cerebral energy metabolism bedside. The LP ratio obtained from microdialysis of cerebral venous blood may be a sensitive indicator of impending cerebral damage and might play a critical role in detecting the early responses of post resuscitation care. Aim of this study is to investigate the global cerebral metabolic changes during CA and post-resuscitation care.","other_id":"S-20150173 HLP","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Diagnostic","masking_description":"Triple","intervention_model_description":"Single center randomized trial with allocation of 60 comatose out-of-hospital cardiac arrest patients undergoing TTM, to normal or high blood pressure target during ICU stay. Secondary a descriptive prospective cohorte study, measuring LP ratio obtained by microdialysis (MD) of the cerebral venous outflow, during the peri-cardiac arrest period","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age 18 years\r\n\r\n          -  Out-of-hospital cardiac arrest (OHCA)\r\n\r\n          -  Presumed cardiac cause\r\n\r\n          -  Unconsciousness (Glasgow Coma Score 8)\r\n\r\n          -  Sustained return of spontaneous circulation (ROSC) (20 minutes of circulation)\r\n\r\n          -  Target temperature management is indicated\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Conscious patients\r\n\r\n          -  Pregnancy\r\n\r\n          -  OHCA of presumed non-cardiac cause\r\n\r\n          -  Cardiac arrest after arrival in hospital\r\n\r\n          -  Known bleeding diathesis\r\n\r\n          -  Suspected or confirmed acute intracranial bleeding\r\n\r\n          -  Suspected or confirmed acute stroke\r\n\r\n          -  Temperature on admission <30C\r\n\r\n          -  Unwitnessed asystole\r\n\r\n          -  Persistent cardiogenic shock\r\n\r\n          -  Known limitations in therapy\r\n\r\n          -  Known disease making 180 day survival unlikely\r\n\r\n          -  Known pre-arrest cerebral performance category 3 or 4\r\n\r\n          -  > 240 minutes from ROSC to randomization\r\n      ","sponsor":"Odense University Hospital","sponsor_type":"Other","conditions":"Cardiac Arrest|Neurological Complication|Post-Cardiorespiratory Arrest Coma","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Low MAP","description":"Extracerebral MD catheters were positioned in a retrograde direction in the internal jugular vein"},{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: High MAP","description":"Extracerebral MD catheters were positioned in a retrograde direction in the internal jugular vein"}],"outcomes":[{"outcome_type":"primary","measure":"LP ratio","time_frame":"Peri-caridac arrest period - 72 hours","description":"Analysis will compare the two target blood pressure groups with respect to lactate/pyruvate (LP) ratio."},{"outcome_type":"secondary","measure":"CPC","time_frame":"72 hours","description":"Cerebral Performance Category (CPC) when discharged from hospital, time to death, daily cumulated vasopressor requirement during ICU stay and need for combination of vasopressors and inotropic agents or mechanical circulatory support.."}]}
{"nct_id":"NCT03426800","start_date":"2017-09-01","phase":"N/A","enrollment":3,"brief_title":"Acupuncture - a Treatment for Children With Headache","official_title":"Acupuncture - a Treatment for Children With Headache","primary_completion_date":"2018-11-06","study_type":"Interventional","rec_status":"Terminated","completion_date":"2018-11-06","last_update":"2018-11-28","description":"Acupuncture as a treatment for headache in children","other_id":"RHN_DMK_01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":9,"maximum_age":17,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosed by pediatrician-\r\n\r\n          -  Age-9-17 years\r\n\r\n          -  Min. headache 8 times within the last month\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Mentally illness\r\n\r\n          -  Fear of needles\r\n      ","sponsor":"Vendsyssel Hospital","sponsor_type":"Other","conditions":"Headache","interventions":[{"intervention_type":"Other","name":"Other: Acupuncture and training","description":"Acupuncture twice in the week in 3 weeks combined with training in 6 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Days with headache","time_frame":"30 days","description":"Number of days with headache"}]}
{"nct_id":"NCT03352635","start_date":"2017-09-01","enrollment":0,"brief_title":"Mechanisms of Ethnic/Racial Differences in Lung Cancer Due to Cigarette Smoking Clinical and Biomarkers Core","official_title":"Mechanisms of Ethnic/Racial Differences in Lung Cancer Due to Cigarette Smoking Clinical and Biomarkers Core: Observation Study","primary_completion_date":"2021-08-30","study_type":"Observational","rec_status":"Withdrawn","completion_date":"2022-08-30","last_update":"2017-11-24","description":"The purpose of the study is to collect human biological samples and measurements from people of various ethnic and racial backgrounds for projects related to the \"Mechanisms of Ethnic/Racial Differences in Lung Cancer Due to Cigarette Smoking\" Program Project Grant. These samples will be used to evaluate and compare biomarkers of tobacco exposure across Japanese Americans, Whites, and Native Hawaiians and to add to the Multiethnic Cohort (MEC) biorepository to develop or assess future biomarkers.","other_id":"5P01CA138388-06","observational_model":"Cohort","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":21,"population":"Cigarette smokers who are Japanese American, Non-Hispanic Whites - two parents of\r\n        non-Hispanic white descent or Native Hawaiians over the age of 18.","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. One of the three targeted ethnic groups: 1)Japanese American - two parents of Japanese\r\n             descent; 2) Non-Hispanic Whites - two parents of non-Hispanic white descent; 3) Native\r\n             Hawaiians will include individuals with at least one parent of Hawaiian descent;\r\n\r\n          2. Smoke 5 cigarettes per day over the past three months;\r\n\r\n          3. >21 years of age;\r\n\r\n          4. Consumes 14 or fewer drinks of alcohol per week;\r\n\r\n          5. Generally stable and good health (determined by review of medical history);\r\n\r\n          6. Able to provide written voluntary consent before performance of any study related\r\n             procedure.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Current use of other nicotine containing products for > 4 times per month (and no use\r\n             of any nicotine-containing products except cigarettes for 2 weeks prior to their study\r\n             visits);\r\n\r\n          2. Acute or uncontrolled medical or psychiatric conditions;\r\n\r\n          3. Currently taking any medications that affect relevant metabolic enzymes or anti-\r\n             inflammatory medications such as ibuprofen (this will be reviewed by study\r\n             investigators on a case-by-case basis);\r\n\r\n          4. Active infection (e.g., influenza, cold, respiratory infection, sinus infection) at\r\n             the time of the visit;\r\n\r\n          5. Pregnant or nursing or planning on becoming pregnant during the study;\r\n\r\n          6. Unable to read and understand English.\r\n      ","sponsor":"University of Minnesota","sponsor_type":"Other","conditions":"Tobacco Use","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Project 3: Analysis of 1,3-butadiene DNA adducts","time_frame":"Baseline","description":"Ethnic differences in butadiene-DNA adducts across racial groups to determine the relationship of DNA adducts to lung cancer and the influence of carcinogen metabolizing genes on DNA adduct formation, repair, and toxicity/mutagenicity."},{"outcome_type":"primary","measure":"Project 4: Correlation of DNA adducts of buccal cells and urinary markers and lung cancer risk","time_frame":"Baseline","description":"DNA adduct levels in oral cells, themselves or together with urinary biomarker levels, correlate with lung cancer risk across various ethnic/racial groups"},{"outcome_type":"primary","measure":"Project 2: NNK α-hydroxylation","time_frame":"Baseline","description":"Analysis of biomarkers of NNK α-hydroxylation (bioactivation) pathway and the effect of P450 2A6 activity on this process."}]}
{"nct_id":"NCT03142750","start_date":"2017-09-01","phase":"N/A","enrollment":24,"brief_title":"Design of a Dressing for Gastrostomy Buttons in Pediatric Population","official_title":"Design of a Dressing for Gastrostomy Buttons in Pediatric Population","primary_completion_date":"2018-05-15","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-08-30","last_update":"2020-01-18","description":"Gastrostomy tube (G-tube) complications, such as granulation tissue formation and tube dislodgements, are frequent causes of emergency department visits. The investigators have developed two G-tube dressing designs using commercially available materials and products to decrease the risk of G-tube related complications. The investigators aim in this study is to pilot two novel G-tube dressings in patients with pre-existing G-tubes to gain parental feedback on device designs, ease of use and G-tube stability in preparation for a final design and trial. Based on the feedback, further iterations will be developed and trialed in eligible study subjects.","other_id":"17-0063","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":0.08493,"maximum_age":25,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with a pre-existing a G-tube\r\n\r\n          -  Patients presenting to the G-tube or surgery clinic for G-tube replacement at\r\n             Children's Hospital, Aurora, Colorado.\r\n\r\n          -  Patients admitted to the hospital with a pre-existing G-tube for reasons unrelated to\r\n             the G-tube will be eligible for the study if they have issues with the G-tube site.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Refusal to participate\r\n\r\n          -  Those with other types of gastrostomy tubes (other than Mini Balloon Button)\r\n\r\n          -  Those whose parents or legal guardians cannot be reached by telephone\r\n\r\n          -  Prisoners\r\n\r\n          -  Pregnant women\r\n\r\n          -  Decisionally challenged subjects\r\n      ","sponsor":"University of Colorado, Denver","sponsor_type":"Other","conditions":"Gastrostomy Complications","interventions":[{"intervention_type":"Device","name":"Device: Gastrostomy tube dressing","description":"Two types of dressings to secure gastrostomy tube in children"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants Satisfied With Current Dressings","time_frame":"Baseline","description":"Overall satisfaction of the current dressings used at baseline were assessed using a qualitative questionnaire. Questionnaires queried the level of agreement in the following aspects: overall satisfaction, ease of use, adequate level of security for the G-button, adherence to skin, ability to absorb leakage, cost, availability at drug store, allergenic potential and reusability. Answer choices to measure level of satisfaction were: strongly agree, agree, neutral, disagree, strongly disagree. Surveys also included open-ended questions about participant satisfaction. Survey responses were evaluated and determined to indicate \"Satisfied\" or \"Not Satisfied\" by the Investigators.This measurement reflects participants satisfaction with whatever dressing they were currently using at baseline, not with the study interventions to which they were assigned."},{"outcome_type":"primary","measure":"Number of Participants Satisfied With Experimental Dressings","time_frame":"1 Week","description":"Overall satisfaction of the dressings when assessed using a qualitative questionnaire. Questionnaires queried the level of agreement in the following aspects: overall satisfaction, ease of use, adequate level of security for the G-button, ease of connecting and disconnecting the feeding tube, reduction in leakage, painless device removal, improvement in gastrostomy wound appearance, preference over the traditional dressing, and whether they would purchase the securement device if it was commercially available. Answer choices to measure level of satisfaction were: strongly agree, agree, neutral, disagree, strongly disagree. Surveys also included open-ended questions about participant satisfaction. Survey responses were evaluated and determined to indicate \"Satisfied\" or \"Not Satisfied\" by the Investigators."}]}
{"nct_id":"NCT03260179","start_date":"2017-08-31","phase":"Phase 1","enrollment":60,"brief_title":"Study to Evaluate the Safety, Preliminary Efficacy and Pharmacokinetics of 3810","official_title":"An Open-label Phase Ib, Study, to Determine Safety of Oral AL3810 in Patients With Locally Advanced or Metastatic Gastric, Hepatocellular or Nasopharyngeal Carcinoma","primary_completion_date":"2019-01-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-06-30","last_update":"2017-08-24","description":"This project intends to make a study of personalized medicine evaluation system establishment for liver cancer, gastric cancer and nasopharynx cancer to provide strong support for the development of Precision Medicine and personalized medicine for the patients of high-incidence-rates cancer in China.","other_id":"CL1-80881-008","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Main criteria for inclusion:\r\n\r\n          1. Adult male or female Chinese subject aged 18 to 70 years, inclusive, at the time of\r\n             signing the informed consent form, with weight at least 40 kg when screening.\r\n\r\n          2. Life expectancy  12 weeks as judged by the Investigator.\r\n\r\n          3. Histologically or cytologically confirmed, locally advanced or metastatic solid tumor\r\n             and be limited to:\r\n\r\n               -  Gastric carcinoma (including gastro-oesophageal junction adenocarcinoma).\r\n\r\n               -  Hepatocellular carcinoma (Child-Pugh Class A).\r\n\r\n               -  Undifferentiated nasopharyngeal carcinoma.\r\n\r\n          4. Each subject should provide at least 5 slides for the formalin fixed and paraffin\r\n             embedded tumor biopsy (undyed) at the baseline, fresh biopsy or most recent primary\r\n             tumor sample or metastatic sample is required.\r\n\r\n          5. Patients, who have progressed on (or not been able to tolerate) standard therapy or\r\n             for whom no standard anticancer therapy exists.\r\n\r\n          6. Toxicities from any prior therapy, surgery, or radiotherapy must have resolved to\r\n             Grade  1 as per the National Cancer Institute- Common Terminology Criteria for\r\n             Adverse Events (NCI-CTCAE), excluding alopecia and peripheral neuropathy. For subjects\r\n             having a prior platinum-based therapy, peripheral neuropathy are required to recover\r\n             to  CTCAE grade 2.\r\n\r\n          7. Per RECIST v1.1 guidelines for solid tumors:\r\n\r\n               -  Patients with gastric carcinoma should have at least one measurable lesion beyond\r\n                  stomach,\r\n\r\n               -  Patients with Hepatocellular carcinoma and undifferentiated nasopharyngeal\r\n                  carcinoma should have at least one measurable lesion.\r\n\r\n          8. Adequate bone marrow and organ function as defined by the following laboratory values:\r\n             (prophylactic use of myeloid growth factors (eg, G-CSF, GM-CSF) is prohibited within 2\r\n             weeks before screening)\r\n\r\n               -  Absolute neutrophil count (ANC)  1.5x 109/L.\r\n\r\n               -  Platelet counts  100 x 109/L.\r\n\r\n               -  Haemoglobin  90 g/L (without blood transfusion within the last 2 weeks from\r\n                  screening).\r\n\r\n               -  Creatinine clearance > 50 mL/min (calculated according to Cockroft-Gault\r\n                  formula).\r\n\r\n               -  Proteinuria < 1+. If proteinuria  1+, urine protein quantitation over 24 hours\r\n                  should be < 1.0 g/24hrs.\r\n\r\n               -  INR  1.5 and APTT 1.5 Upper Limit of Normal (ULN).\r\n\r\n               -  AST, ALT  3 x ULN ( 5 x ULN if liver metastases or hepatocellular carcinomas\r\n                  are present).\r\n\r\n               -  Total Bilirubin < 1.5 x ULN.\r\n\r\n               -  For Hepatocellular carcinomas patients, albumin  28 g/dL.\r\n\r\n          9. Patient has an Eastern Cooperative Oncology Group performance status (ECOG PS)  1.\r\n\r\n         10. Patient is able to swallow and retain oral medication.\r\n\r\n         11. Female subjects, with childbearing potential, has a negative serum pregnancy test at\r\n             screening (within 7 days of the first investigational product administration). The\r\n             definition of women with child-bearing potential are defined as \"All female subjects\r\n             after puberty unless they are post-menopausal or not sexually active\". Females are\r\n             considered postmenopausal if they have age-related amenorrhea  12 consecutive months\r\n             or if they have undergone hysterectomy or bilateral oophorectomy.\r\n\r\n         12. Patients who have fully understood the study, and have signed the general Informed\r\n             Consent Form (ICF) prior to any screening procedures being performed\r\n\r\n        Main criteria for non-inclusion\r\n\r\n          1. Patient who has participated in another interventional trial within 28 days prior to\r\n             starting study medicine. If a subject is joining a non-interventional trial, such as\r\n             an epidemiological study, or in a survival follow-up period of an interventional\r\n             trial, he or she may participate in this trial.\r\n\r\n          2. Expected poor compliance during the study.\r\n\r\n          3. Patient has symptomatic CNS metastases requiring clinical intervention. The stable\r\n             patient may participate in this trial, who must have completed any prior local\r\n             treatment for CNS metastases  14 days prior to the start of study treatment\r\n             (including radiotherapy and/or low dose steroid therapy).\r\n\r\n          4. Patient has a concurrent malignancy or malignancy within 2 years of study enrolment,\r\n             with the exception of adequately treated and cured non-melanomatous skin cancer,\r\n             carcinoma in situ of breast and cervix, and superficial bladder cancer.\r\n\r\n          5. Patient who has received chemotherapy, targeted therapy or immunotherapy within 28\r\n             days or  5 half-lives prior to starting study medicine. Take the longer one. For HCC\r\n             patient who has received any prior local therapy (hepatic arterial embolization,\r\n             transcatheter arterial chemoembolization, chemoembolization, radiofrequency ablation,\r\n             percutaneous ethanol injection or cryoablation) within 4 weeks of starting study\r\n             medicine .\r\n\r\n          6. Previous treatment with Bevacizumab within 3 months of starting AL3810. In addition:\r\n\r\n             - Patients with nasopharyngeal carcinoma who received antiangiogenic agent are not\r\n             allowed.\r\n\r\n          7. Patients with nasopharyngeal carcinoma located within 5mm of large blood vessels.\r\n\r\n          8. Patient who has received wide field radiotherapy within 28 days prior to starting\r\n             study medicine\r\n\r\n          9. Patient who has received a major surgery within 28 days prior to starting study\r\n             medicine. The definition of a major surgery refers to grade 3 and 4 surgery specified\r\n             in <Management of Clinical Practice of Medical Technologies> effective on May 1, 2009\r\n             in China,\r\n\r\n         10. Patient has active cardiac disease or a history of cardiac dysfunction in screening\r\n             including any of the following:\r\n\r\n               -  History of documented Congestive heart failure  class II (NYHA New York Heart\r\n                  Association functional classification) or requiring therapy,\r\n\r\n               -  Ventricular and/or supraventricular arrhythmia requiring therapy;\r\n\r\n               -  Severe conduction disturbance (including QTc interval prolongation > 450msec\r\n                  [corrected by Fredericia formula], history of severe arrhythmia, or history of\r\n                  familial arrhythmia [e.g., Wolff-Parkinson-White syndrome]),\r\n\r\n               -  Angina pectoris requiring therapy,\r\n\r\n               -  Left ventricular ejection fraction (LVEF) < 50% evaluated by cardiac ultrasound\r\n                  (ECHO) or Multi Gated Acquisition Scan (MUGA) ,\r\n\r\n               -  Uncontrolled arterial hypertension (defined as systolic blood pressure  140mmHg\r\n                  and/or diastolic blood pressure  90mmHg with optimized antihypertensive therapy\r\n                  or patients treated with  2 antihypertensive agents),\r\n\r\n               -  Hypertension with systolic blood pressure  160mmHg and/or diastolic blood\r\n                  pressure  100mmHg with or without antihypertensive therapy.\r\n\r\n               -  Conduction abnormality requiring a pacemaker or implanted a pacemaker.\r\n\r\n         11. History of clinically significant or uncontrolled cardiac disease within 6 months\r\n             prior to starting AL3810, including angina, myocardial infarction, and stroke.\r\n\r\n         12. Patients with thromboembolic events within 12 months prior to starting AL3810, or at a\r\n             high risk of such events.\r\n\r\n         13. Patient with hereditary risks of thromboembolic events.\r\n\r\n         14. Patient is currently receiving treatment with warfarin or any other oral\r\n             Anticoagulants\r\n\r\n         15. Patients with active HBV or HCV infection or known positivity for human\r\n             immunodeficiency virus (HIV) infection are not allowed. HBV, HCV and HIV will be\r\n             tested in the screening. Serum HBsAg positive with HBV DNA <104 Copy/mL may\r\n             participate study. Prophylactic anti-HBV medications application can be accepted.\r\n             Serum HCV or HIV antibody positive is not allowed.\r\n\r\n         16. Patients receiving medications known to prolong QTc interval and that may be\r\n             associated with Torsades de Pointes.\r\n\r\n         17. Serum potassium (K+) levels below LLN at screening period.\r\n\r\n         18. Patients who received administration of strong inhibitors of CYP2C8 and/or CYP3A4 or\r\n             strong inducers of CYP3A4 within 7 days or  5 half-lives (Take the longer one) prior\r\n             to starting AL3810. And patient cannot stop taking the medication. .\r\n\r\n         19. Significant gastrointestinal abnormalities, including ulcerative colitis, chronic\r\n             diarrhoea associated with intestinal malabsorption, the Crohn's disease, or\r\n             significant abnormalities decided by investigator. In addition, patients with any\r\n             grade of gastro-intestinal bleeding events within 3 months prior to starting AL3810\r\n             are not allowed.\r\n\r\n         20. History of grade 3 haemorrhage/bleeding events within 6 months prior to starting\r\n             AL3810, or history of grade 4 haemorrhage/bleeding events.\r\n\r\n         21. Known pre-existing clinically significant disorder of the hypothalamic-pituitary axis,\r\n             thyroid and adrenal gland.\r\n\r\n         22. Serious/active bacterial, viral or fungal infection requiring systemic treatment.\r\n\r\n         23. Concomitant uncontrolled severe systemic disease (e.g., uncontrolled diabetes\r\n             mellitus, uncontrolled ascites, etc.).\r\n\r\n         24. Psychiatric disorder or altered mental status that would preclude understanding of the\r\n             informed consent process and/or completion of the necessary study procedures.\r\n\r\n         25. Known organ dysfunction which would either compromise the patient's safety or\r\n             interfere with the evaluation of AL3810.\r\n\r\n         26. Male patients and female patients of child bearing potential unable or unwilling to\r\n             employ effective contraception (abstinence, barrier method with spermicide,\r\n             intrauterine device, or steroidal contraceptive for women and barrier method) during\r\n             the study and for 6 months thereafter.\r\n\r\n         27. Breastfeeding women.\r\n      ","sponsor":"Haihe Biopharma Co., Ltd.","sponsor_type":"Industry","conditions":"Advanced Solid Tumor|Advanced/Metastatic Colorectal Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: AL3810","description":"Fastingoral 4w on or 3w on/1w off"},{"intervention_type":"Drug","name":"Drug: AL3810","description":"Fastingoral 4w on or 3w on/1w off"},{"intervention_type":"Drug","name":"Drug: AL3810","description":"Fastingoral 4w on or 3w on/1w off"}],"outcomes":[{"outcome_type":"other","measure":"CD4+/CD8+","time_frame":"from baseline up to six months(every 8 weeks±7 days )","description":"cell count of CD4+/CD8+"},{"outcome_type":"secondary","measure":"DoR","time_frame":"through study completion, an average of 1 year","description":"All patients with the best overall response to CR or PR were required to calculate the duration of the response. This time is the duration (progression or death, whichever occurs first) from the first decision to CR or PR to tumor progression or death (death for any cause)"},{"outcome_type":"secondary","measure":"DCR","time_frame":"through study completion, an average of 1 year","description":"DCR refers to the percentage of patients who have achieved confirmation during the treatment of CR, confirmed PR and / or SD"},{"outcome_type":"primary","measure":"AE","time_frame":"through study completion, an average of 1 year","description":"the number of patients with grade 3 and 4 AE according to CTC AE 4.03"},{"outcome_type":"secondary","measure":"ORR","time_frame":"through study completion, an average of 1 year","description":"The proportion of patients who have observed overall remission (CR) or partial remission (PR) as the overall optimal remission based on the RECIST 1.1."},{"outcome_type":"secondary","measure":"AUC","time_frame":"up to 3 cycles(28 days/cycle)","description":"Area under the plasma concentration versus time curve"},{"outcome_type":"secondary","measure":"Cmax","time_frame":"up to 3 cycles(28 days/cycle)","description":"Peak Plasma Concentration"},{"outcome_type":"secondary","measure":"PFS","time_frame":"through study completion, an average of 1 year","description":"To the date of randomization to the date of the onset of the disease or the date of death (regardless of the cause of the death) (whichever is the earlier)."},{"outcome_type":"other","measure":"Growth factor","time_frame":"from baseline up to six months(every 8 weeks±7 days ), C1D15","description":"the content of growth factor such as VEGF，FGF and PDGF in plasma"},{"outcome_type":"other","measure":"Exosomes","time_frame":"from baseline up to six months(every 8 weeks±7 days )","description":"the content of growth factor such as INFγ and cMyc in plasma"}]}
{"nct_id":"NCT03662646","start_date":"2017-08-31","enrollment":60,"brief_title":"Circadian Rhythms in IBD Patients Upon Diagnosis","official_title":"Clock Gene Disruption May be an Initial Manifestation of IBD.","primary_completion_date":"2018-08-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2018-08-31","last_update":"2018-09-07","description":"patients under the age of 15 years old upon diagnostic evaluation will be recruited . study population will comprise of two groups: newly diagnosed IBD patients and healthy controls. upon enrollment, subjects will fill out sleeping habits questioners, demographic data, medical history. blood samples will be drawn for CRP and clock gene expression in systemic WBC. intestinal biopsies will be snap frozen for clock gene extraction and amplification.","other_id":"TASMAC-16-YW-0200-CTIL","observational_model":"Case-Control","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":6,"maximum_age":25,"population":"patients performing endoscopic procedures in our institute.","criteria":"\n        Inclusion Criteria:\r\n\r\n        - patients admitted to perform endoscopic workup for gastrointestinal complaints.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  1. known and treated IBD. 2. current immunosupresive treatment. 3. genetic disorder.\r\n             4. known immunodeficiency. 5. pregnancy.\r\n      ","sponsor":"Tel-Aviv Sourasky Medical Center","sponsor_type":"Other","conditions":"Inflammatory Bowel Diseases|Circadian Dysregulation","interventions":[{"intervention_type":"Other","name":"Other: no intervention performed- observational only","description":"no intervention performed- observational only"}],"outcomes":[{"outcome_type":"primary","measure":"clock gene expression levels in intestinal mucosal samples and WBC peripheral blood.","time_frame":"two years","description":"PCR amplification levels"}]}
{"nct_id":"NCT03264235","start_date":"2017-08-30","phase":"N/A","enrollment":30,"brief_title":"The Effect of Powered-Knee Exoskeleton Assist on Stair Climbing in Acute CVA","official_title":"The Effect of Powered-Knee Exoskeleton Assist on Stair Climbing in Acute Cerebrovascular Accidents","primary_completion_date":"2021-08-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-08-31","last_update":"2021-03-17","description":"Hypothesis/Specific Aims: The purpose of this research study is to determine if using an exoskeleton during stair climbing training will result in an improved ability to walk and climb stairs in individuals affected by recent stroke as compared to stair climbing training without an exoskeleton.","other_id":"NUSTU00205454","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Participants will be randomized into one of two groups. Group 1 will wear the exoskeleton device while completing all training sessions and will participate in 30 minutes of stair training in the device. Group 2 will not wear the exoskeleton device during training sessions and will be participate in 30 minutes of stair training without the device.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patient in the inpatient rehabilitation setting\r\n\r\n          -  less that 3 months post-hemorrhagic or ischemic cerebrovascular accident (CVA)\r\n\r\n          -  No previous diagnosis or treatment for CVA\r\n\r\n          -  Acute inpatient rehabilitation discharge goal of stair negotiation\r\n\r\n          -  18 years of age or older\r\n\r\n          -  Waist and leg circumference and lower extremity lengths appropriate for a comfortable\r\n             and safe fit in the Keeogo study device\r\n\r\n          -  Medical clearance from a Shirley Ryan AbilityLab (SRALAB) inpatient physician\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Unwilling to participate\r\n\r\n          -  Unable to provide autonomous consent due to cognitive or communication impairment\r\n\r\n          -  Legally blind\r\n\r\n          -  Pregnant or lactating\r\n\r\n          -  Skin condition that contraindicates use of orthotics or support braces\r\n\r\n          -  History of multiple CVA\r\n\r\n          -  History of any additional neuropathology diagnosis, such as Parkinson's disease,\r\n             multiple sclerosis, traumatic brain injury, or spinal cord injury\r\n      ","sponsor":"Shirley Ryan AbilityLab","sponsor_type":"Other","conditions":"Stroke, Acute|Gait Disorders, Neurologic","interventions":[{"intervention_type":"Device","name":"Device: Keeogo","description":"Keeogo is a computer-controlled lower extremity motorized orthosis worn over the user's hips and legs. The controller box contains sensors that supply information about the kinematics and the kinetics of the user's lower extremities and includes software that recognizes the user's mobility intentions. The system is powered by a lithium-polymer battery. The leg brace assembly is mainly comprised of the actuator, the electronic boards, hip joint, and soft goods (cuffs, belts) for affixing the assembly to the user's legs. The waist belt comes in various sizes adapted to each wearer, and adds additional support of the device on the user.\r\nKeeogo does not initiate any movement but waits for the user's lead. Once the user makes the first move, Keeogo assists according to the activity. The individual must be able to initiate and terminate steps."},{"intervention_type":"Other","name":"Other: Traditional Stair Training","description":"Individuals will participate in traditional stair training physical therapy for the same duration of time as Group 1."}],"outcomes":[{"outcome_type":"primary","measure":"Change in Timed Stair Climb Test speed from baseline","time_frame":"Initial Visit (Week 1); Post testing (Week 2)","description":"The timed stair test is best conducted in a standard interior stair-well with guard rails and preferably 10 steps between landings, with a minimum of 8 steps and a maximum of 12 steps. The landing space is required to ensure safe turning. The patient will be instructed to ascend and descend the stair case \"as quickly and safely\" as possible.\r\nTo start the test, the patient is asked to stand at the bottom of the stair case, and a countdown provided \"one, two, ready, go\" where the patient initiates stair ascent at the \"go\" cue, and the tester starts the stop watch.\r\n• The patient ascends the stair case, turns and descends the stair case, coming to a stop at the bottom of the stair case. The tester will lap the time for the ascent period and the descend period, and records these \"Test 1\" times.\r\nThis will be repeated for a total of two trials."},{"outcome_type":"secondary","measure":"5-times Sit to Stand Test","time_frame":"Initial Visit (Week 1); Post testing (Week 2)","description":"Method:\r\nUse a straight back chair with a solid seat that is 16\" high. Ask participant to sit on the chair with arms folded across their chest.\r\nInstructions:\r\n\"Stand up and sit down as quickly as possible 5 times, keeping your arms folded across your chest.\"\r\nMeasurement:\r\nStop timing when the participant stands the 5th time."},{"outcome_type":"secondary","measure":"GAITRite Data Collection","time_frame":"Initial Visit (Week 1); Post testing (Week 2)","description":"The GAITRite system automates measuring temporal and spatial gait parameters via an electronic walkway connected to a computer. The GAITRite electronic walkway contains sensor pads encapsulated in a carpet to collect gait information. The system can be laid over any flat surface. The GAITRite electronic walkway for the study shall be a minimum of 14 feet long. The GAITRite data capture was chosen as measurement of the patient's overall gait quality. Patients will be asked to walk at a self-selected speed across the GAITRite electronic walkway with at least a two meter \"flying start\" to compensate for initial acceleration."}]}
{"nct_id":"NCT03289494","start_date":"2017-08-30","phase":"N/A","enrollment":9,"brief_title":"Evaluation of 2 Diets With Different Starch Digestibility Profiles on Daily Glycemic Profile, in T2D Patients","official_title":"A Pilot Randomized Controlled Trial Evaluating the Effect of Two Diets With Different Starch Digestibility Profiles on Daily Glycemic Profile Measured by Continuous Glucose Monitoring System (CGMS), in Type 2 Diabetic Patients","primary_completion_date":"2018-07-24","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-07-24","last_update":"2020-05-27","description":"The study is a randomized cross-over pilot study. The research hypothesis is that the diet high in SDS content (H-SDS) will lower the daylong glycemic response and improve the glycemic control in patients with type 2 diabetes (T2D) compared to the diet low in SDS content (L-SDS).","other_id":"KBE052","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Prevention","masking_description":"Single","intervention_model_description":"Each subject will receive two independant weeks of diet intervention, in a crossover design","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patient able to understand the study information and providing written consents for\r\n             his/her participation to the study\r\n\r\n          -  Male or female\r\n\r\n          -  Patient undergoing medical examination during the selection visit\r\n\r\n          -  Patient aged between 18 and 75 years old (bounds included)\r\n\r\n          -  T2D volunteer with:\r\n\r\n               -  HbA1c between 6,5% and 8,5%\r\n\r\n               -  Bi-therapy associating metformin and sitagliptin at stable dose for at least 1\r\n                  month\r\n\r\n          -  T2D volunteer without insulin therapy or GLP-1 analogues\r\n\r\n          -  Patient with BMI ranging between 22 and 37 kg/m2 (bounds included)\r\n\r\n          -  Patient with stable body weight over the past three months (+/- 5 % of body weight)\r\n\r\n          -  Patient accepting to change its diet for two weeks\r\n\r\n          -  Patient not suffering from intolerance or allergy\r\n\r\n          -  Patient regularly consuming products proposed in the study\r\n\r\n          -  Patient regularly consuming 3 main meals per day\r\n\r\n          -  Sedentary behavior or stable regular physical activity during the study\r\n\r\n          -  Patient not presenting any disease during the medical examination / interview which\r\n             could interfere with the results of the study according to the investigator\r\n\r\n          -  Patient covered by health assurance\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  General criteria:\r\n\r\n               -  Patient under legal protection measure\r\n\r\n               -  Patient deprived of liberty by a court or an administrative decision\r\n\r\n               -  Patient currently participating in another study or being in the exclusion period\r\n                  of another study\r\n\r\n               -  Volunteer that exceed the financial compensation allowed per year for\r\n                  participating in research programs\r\n\r\n          -  Biological criteria:\r\n\r\n               -  Gamma-GT > 2.5 times above the norm (>160 UI/L)\r\n\r\n               -  ASAT > 2.5 times above the norm (>85 UI/L)\r\n\r\n               -  ALAT > 2.5 times above the norm (>137.5 UI/L)\r\n\r\n               -  Triglycerides > 4 g/L\r\n\r\n               -  LDL-cholesterol > 1.90 g/L\r\n\r\n               -  CRP > 15 mg/L\r\n\r\n               -  Hemoglobin < 120 mg/dL\r\n\r\n               -  Other biological abnormality with clinical significant relevance according to the\r\n                  investigator\r\n\r\n          -  Therapeutic and medical criteria:\r\n\r\n               -  Patient with type 1 diabetes\r\n\r\n               -  T2D treatment other than metformin and sitagliptin\r\n\r\n               -  Patient with past bariatric surgery\r\n\r\n               -  Patient with medical history of endocrine diseases who may interfere with glucose\r\n                  metabolism according to the investigator (such as thyroid dysfunction,\r\n                  acromegaly, hypercorticism)\r\n\r\n               -  Uncontrolled high blood pressure defined by Systolic blood pressure > 150 mmHg or\r\n                  Diastolic blood pressure > 100 mmHg\r\n\r\n               -  Evidence of any other unstable or untreated clinically significant immunological,\r\n                  neoplasic, endocrine, haematological, gastrointestinal, hepatic, neurological or\r\n                  psychiatric abnormalities or medical disease according to the investigator\r\n\r\n               -  Pregnant women or willing to become pregnant or lactating women\r\n\r\n               -  Women of childbearing age without an efficient contraceptive method according to\r\n                  the investigator\r\n\r\n               -  Patient under a restrictive diet or willing to lose weight\r\n\r\n               -  Patient with eating disorders (e.g. anorexia nervosa and bulimia) according to\r\n                  the investigator\r\n\r\n               -  Patient without stable dietary habits or with specific diet (vegetarian, vegan,)\r\n                  according to the investigator\r\n\r\n               -  Patient who smokes\r\n\r\n               -  Patient regularly consuming more than 20 g/day of alcohol. Consumption of more\r\n                  than 3 alcoholic beverages per day is recognized as excessive. An alcoholic\r\n                  beverage is: 30 mL of spirituous, 120 mL of wine or 330 mL of beer\r\n\r\n               -  Patient regularly consuming recreational drugs\r\n\r\n               -  Patient consuming in the two previous months regularly corticoids, anorectics,\r\n                  adrenergic drugs, beta-blocking drugs, antiplatelet agent (like aspirin) or other\r\n                  drugs or supplement that should impact glucose metabolism (other than metformin\r\n                  or DPP4 inhibitor) in the investigator's opinion\r\n\r\n               -  Adhesive plaster skin allergy\r\n      ","sponsor":"Mondelz International, Inc.","sponsor_type":"Industry","conditions":"Type2 Diabetes","interventions":[{"intervention_type":"Other","name":"Other: Balanced diet high in Slowly Digestible Starch","description":"The carbohydrate present in the diet high in Slowly Digestible Starch were selected according to the general recommendations made for diabetics and according to their SDS content. The diet will be consumed during one week."},{"intervention_type":"Other","name":"Other: Balanced diet low in Slowly Digestible Starch","description":"The carbohydrate present in the diet low in Slowly Digestible Starch were selected according to the general recommendations made for diabetics and according to their SDS content. The diet will be consumed during one week."}],"outcomes":[{"outcome_type":"primary","measure":"Mean postprandial incremental Area Under the Curve (iAUC), measured by CGMS","time_frame":"minimum 2h to maximum 6h postprandial periods and average value of minimum 3 days to a maximum of 6 days of CGMS record","description":"The iAUC will be calculated using the trapezoid rule. The iAUC includes all area below the curve and above the fasting concentration, with any area beneath fasting being ignored."},{"outcome_type":"secondary","measure":"Glycemic profile parameters: Minimum glycaemia","time_frame":"minimum 3 days to a maximum of 6 days of CGMS record","description":"Minimum glycaemia"},{"outcome_type":"secondary","measure":"Glycemic profile parameters: maximum glycaemia","time_frame":"minimum 3 days to a maximum of 6 days of CGMS record","description":"maximum glycaemia"},{"outcome_type":"secondary","measure":"Glycemic profile parameters: Standard Deviation (SD) from CGMS glycaemia","time_frame":"minimum 3 days to a maximum of 6 days of CGMS record","description":"Standard Deviation (SD) from CGMS glycaemia"},{"outcome_type":"secondary","measure":"Glycemic profile parameters: Coefficient of Variation (CV) from CGMS glycaemia","time_frame":"minimum 3 days to a maximum of 6 days of CGMS record","description":"Coefficient of Variation (CV) from CGMS glycaemia"},{"outcome_type":"secondary","measure":"Glycemic profile parameters: MAGE","time_frame":"minimum 3 days to a maximum of 6 days of CGMS record","description":"Mean Amplitude of Glycemic Excursions (MAGE) from CGMS glycaemia"},{"outcome_type":"secondary","measure":"Glycemic profile parameters: MODDs","time_frame":"minimum 3 days to a maximum of 6 days of CGMS record","description":"Mean Of Daily Differences (MODDs) from CGMS glycaemia"},{"outcome_type":"secondary","measure":"Glycemic profile parameters: MIME","time_frame":"minimum 3 days to a maximum of 6 days of CGMS record","description":"Mean Indices of Meal Excursions (MIME) from CGMS glycaemia"},{"outcome_type":"secondary","measure":"Glycemic profile parameters: Time in Range","time_frame":"minimum 3 days to a maximum of 6 days of CGMS record","description":"Mean time spent in the appropriate glycemic range in %"},{"outcome_type":"secondary","measure":"Glycemic profile parameters: ADRR","time_frame":"minimum 3 days to a maximum of 6 days of CGMS record","description":"Average of Daily Risk Ratio (ADRR) from CGMS glycaemia"},{"outcome_type":"secondary","measure":"Glycemic profile parameters: CONGA","time_frame":"minimum 3 days to a maximum of 6 days of CGMS record","description":"Continuous Overall Net Glycemic Action (CONGA) from CGMS glycaemia"},{"outcome_type":"secondary","measure":"Glycemic profile parameters: hyperglycemia durations","time_frame":"minimum 3 days to a maximum of 6 days of CGMS record","description":"hyperglycemia durations"},{"outcome_type":"secondary","measure":"Glycemic profile parameters: hypoglycemia durations","time_frame":"minimum 3 days to a maximum of 6 days of CGMS record","description":"hypoglycemia durations"},{"outcome_type":"secondary","measure":"Glycemic profile parameters: mean glycemic value","time_frame":"minimum 3 days to a maximum of 6 days of CGMS record","description":"mean glycemic value on relevant time interval"},{"outcome_type":"secondary","measure":"Glycemic profile parameters: incremental AUC","time_frame":"minimum 3 days to a maximum of 6 days of CGMS record","description":"incremental AUC calculated on relevant time interval"},{"outcome_type":"secondary","measure":"Glycemic profile parameters: total AUC","time_frame":"minimum 3 days to a maximum of 6 days of CGMS record","description":"total AUC calculated on relevant time interval, calculated using the trapezoid rule and including all area below the curve"},{"outcome_type":"secondary","measure":"Glycemic profile parameters: kinetics","time_frame":"minimum 3 days to a maximum of 6 days of CGMS record","description":"Daylong glycaemia kinetics"},{"outcome_type":"secondary","measure":"Compliance parameters: mean SDS ingestion","time_frame":"maximum of 6 days of LogBook record","description":"mean SDS ingestion by type of meal and per day"},{"outcome_type":"secondary","measure":"Dietary intake evaluation","time_frame":"After 1 week intervention diet","description":"Dietary record analysis, in g of macronutrient intake"},{"outcome_type":"secondary","measure":"Dietary record evaluation","time_frame":"After 1 week intervention diet","description":"Dietary record analysis, in % of total energy intake"},{"outcome_type":"secondary","measure":"Charaterisation of acceptability to H-SDS diet in free living conditions","time_frame":"After 1 week intervention diet","description":"Feedback questionnaire"}]}
{"nct_id":"NCT03152760","start_date":"2017-08-28","enrollment":35,"brief_title":"Exploring Gut-Brain and Brain-Gut Interactions in Alcohol Use Disorder Via Microbiota Investigations: A Pilot Study","official_title":"Exploring Gut-Brain and Brain-Gut Interactions in Alcohol Use Disorder Via Microbiota Investigations: A Pilot Study","primary_completion_date":"2020-03-04","study_type":"Observational","rec_status":"Completed","completion_date":"2020-11-24","last_update":"2021-09-20","description":"Background: Alcohol use disorder (AUD) affects about 10 percent of people in the U.S. Studies show a relationship between the bacteria (microbiota) in the gut and the brain. Researchers think this may influence AUD. They want to learn more about changes in gut bacteria that may occur in people with AUD. Objectives: To study gut microbiota differences in current drinking versus abstinent people with AUD. Also to test if gut microbiota are related to alcohol cue-induced craving. Eligibility: People ages 21-70 who have AUD (both abstinent and current heavy drinkers) or are healthy, moderate drinkers Design: Participants will be screened in Protocol 14-AA-0181. Participants will have a first visit. They will have 4 more visits within about 10 days. Visits include: Fecal sample collection Physical exam Blood tests Assessment of diet and alcohol use X-rays to test body composition, They will sit under a ventilation hood to measure metabolism. They must fast 12 hours before this test. They will drink a solution. Their urine is collected over 5 hours. Ultrasound of the liver area. They must fast overnight before this test. At 2 visits, they will be in a bar-like setting. They will be exposed to stimuli associated with eating and drinking. They will rate their urge to drink alcohol and their food cravings. Participants will collect their stool throughout the study. They will also record information about their diet and daily activities like sleep and exercise. At the end of the study, participants will discuss their drinking. They will receive counseling if needed. ...","other_id":"170093","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":21,"maximum_age":70,"population":"Male or female individuals 21-70 years oldIndividuals may come to the NIH/NIAAA from a\r\n        variety of community settings ranging from primary residences, shelters and/or other health\r\n        care facilities","criteria":"\n        -  INCLUSION CRITERIA:\r\n\r\n          -  Male or female individuals 21-70 years old (inclusive)\r\n\r\n        Specific For Abstinent Group; AB\r\n\r\n          -  Current Alcohol Use Disorder (AUD) by DSM-5 criteria\r\n\r\n          -  Being alcohol abstinent for at least 4 weeks, with a minimum of 2 weeks in a\r\n             non-protective environment at the time of study screening.\r\n\r\n        Specific For Current Drinking Group; CD\r\n\r\n          -  Current Alcohol Use Disorder (AUD) by DSM-5 criteria\r\n\r\n          -  Participants not seeking treatment for their alcohol use will be included.\r\n\r\n          -  Satisfying heavy drinking criteria during the 4-weeks prior to screening (i.e., for\r\n             men, >14 standard drinks in any one week or greater than or equal to 4 drinks per\r\n             occasion at least once per month over the past 30 days; for women, >7 drinks per week\r\n             or greater than or equal to 3 drinks per occasion at least at least once per month\r\n             over the past 30 days) and any drinking during the 2-day prior to signing the\r\n             study-specific consent.\r\n\r\n        Specific For Healthy Control Group; HC\r\n\r\n          -  No current or past diagnostic of AUD by DSM-5 criteria\r\n\r\n          -  Moderate alcohol consumers: i.e., up to 1 drink per day on average and not meeting\r\n             NIAAA criteria for:\r\n\r\n          -  -heavy (i.e., for men, >14 standard drinks in any one week or greater than or equal to\r\n             4 drinks per occasion at least once per month over the past 30 days; for women, >7\r\n             drinks per week or greater than or equal to 3 drinks per occasion at least at least\r\n             once per month over the past 30 days)\r\n\r\n          -  -or binge drinking (i.e., drinking 5 or more standard drinks on the same occasion on\r\n             at least 1 day in the past 30 days for both male and female)\r\n\r\n        If any answer is No , subject may not be enrolled.\r\n\r\n        EXCLUSION CRITERIA:\r\n\r\n        Exclusion - All Participants (at the time subject are evaluated for this protocol)\r\n\r\n          -  Current pregnancy or lactation\r\n\r\n          -  Positive Urine Drug Test for illegal drugs\r\n\r\n          -  Body Mass Index (BMI) less than or equal to 18.5 kg/m(2) or BMI greater than or equal\r\n             to 40 kg/m(2)\r\n\r\n          -  Presence of active implantable electronic devices (e.g., defribillators, pumps,\r\n             pacemakers)\r\n\r\n          -  Current medical history of the following medical conditions:\r\n\r\n             --diabetes; chronic gut inflammatory diseases; GI or any other type of cancer; short\r\n             bowel syndrome; conditions requiring parenteral nutrition;\r\n\r\n          -  Diarrhea or other symptoms of possible enteritis in the past 7 days (self-reported)\r\n\r\n          -  Recent history of sigmoidoscopy or colonoscopy (past 30 days)\r\n\r\n          -  Current use (past 90 days) of the following medications:\r\n\r\n             --oral antimicrobials (specifcally: antiviral, antifungal, or antibiotics);\r\n             prebiotics; probiotics; laxatives; antispasmodic drugs; oral, IM or IV steroids\r\n\r\n          -  Any other reason or clinical condition that the PI, or Medical Advisory Investigator\r\n             (MAI) considers unsafe or not in the best interest of the study research integrity\r\n\r\n        If any answer is Yes , subject may not be enrolled.\r\n      ","sponsor":"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","sponsor_type":"NIH","conditions":"Alcoholism","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Observed differences in composition and function of microbiome between cohorts","time_frame":"10-day time frame","description":"To investigate the primary aim, participants' gut microbiota will be collected and analyzed to compare the three groups."},{"outcome_type":"secondary","measure":"The secondary aims will be to examine whether participants' gut microbiota composition is associated with biobehavioral correlates as alcohol cue- induced craving during a Cue-reactivity procedure.","time_frame":"10-day time frame","description":"1.To examine whether participants' gut microbiota composition is associated with biobehavioral correlates as alcohol cue-induced craving during a Cue-reactivity procedure."}]}
{"nct_id":"NCT03403725","start_date":"2017-08-28","phase":"Phase 1","enrollment":28,"brief_title":"MEN1309 Intravenous Infusion in Patients With CD205-positive Metastatic Solid Tumors and Relapsed or Refractory Non-Hodgkin Lymphoma Phase I Study","official_title":"Open-Label, Multicenter, Phase I Dose Escalation Study of MEN1309, a CD205 Antibody-Drug Conjugate,in Patients With CD205-Positive Metastatic Solid Tumors and Non-Hodgkin Lymphoma","primary_completion_date":"2019-10-22","study_type":"Interventional","rec_status":"Terminated","completion_date":"2020-01-08","last_update":"2020-03-10","description":"The purpose of this clinical trial is to identify the highest dose of MEN1309 drug with acceptable safety profile and that can be used in patients affected by CD205-positive solid tumors and Non-Hodgkin Lymphoma","other_id":"MEN1309-01","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Main Inclusion Criteria:\r\n\r\n          1. Male or female patients aged  18 years.\r\n\r\n          2. Patients with:\r\n\r\n               -  confirmed diagnosis of advanced or metastatic solid tumor and diagnosis of\r\n                  multiple relapsed or refractory NHL;\r\n\r\n               -  progressive after last treatment received;\r\n\r\n               -  availability of archived tumor material, either as a block or slides;\r\n\r\n               -  measurable or evaluable disease by Response Evaluation Criteria in solid tumors\r\n                  guideline (RECIST v1.1) and by Cheson Criteria (The Lugano Classification, 2014)\r\n                  in NHL.\r\n\r\n          3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2.\r\n\r\n          4. Neutrophil count  1,500/L; platelets  100,000/L; haemoglobin  9 g/dL.\r\n\r\n          5. Adequate renal and hepatic laboratory assessments.\r\n\r\n          6. Life expectancy of at least 2 months.\r\n\r\n          7. Woman of childbearing potential (WOCBP) who agrees to use highly effective\r\n             contraception (see Appendix I).\r\n\r\n        Main Exclusion Criteria:\r\n\r\n          1. Central nervous system involvement (excluding treated stable cerebral metastasis, not\r\n             requiring therapy to control symptoms in the last 60 days).\r\n\r\n          2. Pregnant or breastfeeding women.\r\n\r\n          3. Life-threatening illnesses other than solid tumors and NHL, uncontrolled medical\r\n             conditions or organ system dysfunction which, in the Investigator's opinion, could\r\n             compromise the patient's safety, or put the study outcomes at risk.\r\n\r\n          4. Less than 2 previous cancer treatments, including high dose chemotherapy and ASCT, for\r\n             NHL unless patient refuses standard therapy and/or is not eligible for ASCT.\r\n\r\n          5. Have significant, uncontrolled, or active cardiovascular disease.\r\n      ","sponsor":"Menarini Group","sponsor_type":"Industry","conditions":"Metastatic Solid Tumors|Relapsed/Refractory Non-Hodgkin Lymphoma","interventions":[{"intervention_type":"Drug","name":"Drug: MEN1309","description":"MEN1309 solution for intravenous infusion once every 3 weeks"}],"outcomes":[{"outcome_type":"secondary","measure":"Overall Survival","time_frame":"Through study completion, an average of 3 years"},{"outcome_type":"secondary","measure":"Progression free survival","time_frame":"Through study completion, an average of 3 years"},{"outcome_type":"secondary","measure":"Treatment Emergent Adverse Events (TEAEs)","time_frame":"Through study completion, an average of 3 years","description":"Incidence, intensity, CTCAE version 4.03 grading, seriousness and treatment-causality of TEAEs"},{"outcome_type":"primary","measure":"Maximum-Tolerated Dose (MTD)","time_frame":"21-day period after the first dose"},{"outcome_type":"primary","measure":"Dose-Limiting Toxicity (DLT)","time_frame":"21-day period after the first dose"},{"outcome_type":"secondary","measure":"MEN1309 Pharmacokinetic (PK) parameter Cmax","time_frame":"Day 1, 2, 3, 4, 8 and 15 of each cycle (each cycle is 21 days)","description":"Cmax is the maximum serum drug concentration"},{"outcome_type":"secondary","measure":"MEN1309 Pharmacokinetic (PK) parameter Cmax (tmax)","time_frame":"Day 1, 2, 3, 4, 8 and 15 of each cycle (each cycle is 21 days)","description":"time to achieve maximum serum drug concentration"},{"outcome_type":"secondary","measure":"MEN1309 Pharmacokinetic (PK) parameter Ctrough","time_frame":"Day 1, 2, 3, 4, 8 and 15 of each cycle (each cycle is 21 days)","description":"pre-dose serum concentration"},{"outcome_type":"secondary","measure":"MEN1309 Pharmacokinetic (PK) parameter t1/2","time_frame":"Day 1, 2, 3, 4, 8 and 15 of each cycle (each cycle is 21 days)","description":"terminal serum half-life"},{"outcome_type":"secondary","measure":"MEN1309 Pharmacokinetic (PK) parameter AUC","time_frame":"Day 1, 2, 3, 4, 8 and 15 of each cycle (each cycle is 21 days)","description":"area under curve"},{"outcome_type":"secondary","measure":"MEN1309 Pharmacokinetic (PK) parameter CL","time_frame":"Day 1, 2, 3, 4, 8 and 15 of each cycle (each cycle is 21 days)","description":"systemic clearance"},{"outcome_type":"secondary","measure":"MEN1309 Pharmacokinetic (PK) parameter Vd","time_frame":"Day 1, 2, 3, 4, 8 and 15 of each cycle (each cycle is 21 days)","description":"volume of distribution based on the terminal phase"},{"outcome_type":"secondary","measure":"Incidence of anti-MEN1309 antibodies","time_frame":"Day 1 of each Cycle (each cycle is 21 days)"},{"outcome_type":"secondary","measure":"Correlation of CD205 expression in tumors with clinical activity of MEN1309 assessed according to RECIST 1.1 or Cheson Criteria (2014) in terms of Response Rate, Disease control rate, duration of response, overall survival, and progression free survival","time_frame":"Through study completion, an average of 3 years"}]}
{"nct_id":"NCT04063007","start_date":"2017-08-15","phase":"N/A","enrollment":60,"brief_title":"Epigenetics and Gut Microbiota in Children With Epilepsy","official_title":"The Potential Impact of the Ketogenic Diet on Epigenetics and Gut Microbiota in Children With Epilepsy","primary_completion_date":"2021-07-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-10-31","last_update":"2019-08-20","description":"The ketogenic diet is a high-fat, low-carbohydrate diet used in the treatment of epilepsy. The diet can be an efficient treatment option in children with drug resistant epilepsy, with more than 50 % seizure reduction in about 40- 70 % of the patients. However, there is still a lack of knowledge regarding the mechanisms of action, how will respond to the treatment and potential adverse effects.","other_id":"2016/2016/REK sr-st","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"This is a prospective, non-randomized study","sampling_method":"","gender":"All","minimum_age":2,"maximum_age":17,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Drug resistant epilepsy\r\n\r\n          -  Age 2- 17 years\r\n\r\n          -  Two or more countable seizures/week\r\n\r\n          -  Willing to try treatment with the ketogenic diet for at least 12 weeks\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Glucose transporter protein 1 deficiency, pyruvate dehydrogenase deficiency, or\r\n             pyruvate carboxylase deficiency\r\n\r\n          -  Known or suspected disease in wich the diet is contraindicated\r\n\r\n          -  Epilepsy surgery the last 6 months before diet initiation\r\n\r\n          -  Steroid medications the last 2 months before diet initiation\r\n\r\n          -  Breastfeeding\r\n\r\n          -  Psychogenic non-epileptic seizures\r\n\r\n          -  Eating disorder\r\n\r\n          -  Pregnancy or planed pregnancy\r\n\r\n          -  Feeding disabilities not compatible with dietary treatment\r\n\r\n          -  Inability to follow study scheme\r\n\r\n          -  Previous treatment with high-fat, low- carbohydrate diet\r\n\r\n          -  Medical need to start dietary treatment immediately\r\n      ","sponsor":"Oslo University Hospital","sponsor_type":"Other","conditions":"Epilepsy","interventions":[{"intervention_type":"Other","name":"Other: Ketogenic diet","description":"The patients follow the ordinary treatment protocol for ketogenic diet"}],"outcomes":[{"outcome_type":"primary","measure":"Characterization of the gut microbiota","time_frame":"From baseline to 12 weeks of dietary treatment.","description":"Changes in the gut microbiota composition in fecal samples from baseline to 12 weeks of dietary treatment will be measured by 16S rRNA analysis."},{"outcome_type":"primary","measure":"Characterization of DNA methylation","time_frame":"From baseline to 12 weeks of dietary treatment.","description":"Changes in the DNA methylation in white blood cells from baseline to 12 weeks of dietary treatment will be analyzed using the Infinium Methylation EPIC Kit."},{"outcome_type":"secondary","measure":"Quality of life","time_frame":"12 weeks of dietary treatment.","description":"The impact of the dietary treatment on quality of life will be examined by using a questionaire before and after 12 weeks of dietary treatment. The quality of life score is a parental measure of the impact for the family, based on their hopes and expectations of the effects of the ketogenic diet.The quality of life is rate on a scale from 0 to 10 (0 = quality of life is poor, 10 = quality of life is very good)"},{"outcome_type":"secondary","measure":"Adverse effects","time_frame":"12 weeks of dietary treatment.","description":"To identify potential adverse effects induced by the dietary treatment measured by a structured interview."}]}
{"nct_id":"NCT03281499","start_date":"2017-08-15","phase":"N/A","enrollment":22,"brief_title":"Transoral Robotic Surgery and Tailored Radiotherapy in Unknown Primary and Small Squamous Cell Head and Neck Cancer","official_title":"A Pilot Study Integrating Transoral Robotic Surgery, Histopathologic Localization, and Tailored De-Intensification of Radiotherapy for Unknown Primary and Small Oropharyngeal Head and Neck Squamous Cell Carcinoma(FIND Trial)","primary_completion_date":"2022-08-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2022-08-31","last_update":"2021-04-19","description":"The purpose of this study is to evaluate the use of Transoral Robotic Surgery (TORS) to identify small oropharyngeal carcinomas. Findings from this study will be used to better determine which patients may be suitable for more targeted radiotherapy that would lead to a reduction in the total amount of radiotherapy needed as part of their treatment. Reducing the amount of radiotherapy received has been found to reduce the risk of late complications and toxicity to the patient.The pathologic findings will then be used to determine patients who may be candidates for de-intensification of radiotherapy.","other_id":"FIND Trial","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"There will only be a single group of participants in this study","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age >= 18\r\n\r\n          -  Metastatic squamous cell carcinoma (T0,N1-3,M0) to at least one regional lymph node of\r\n             the neck (includes N1-N3) based on fine needle aspiration (FNA) biopsy, core biopsy,\r\n             excisional biopsy, or neck dissection\r\n\r\n          -  Ability to understand and willing to sign a written informed consent document\r\n\r\n          -  Women of child-producing potential must agree to use effective contraceptive methods\r\n             prior to study entry, during study participation, and for at least 30 days after the\r\n             last administration of study medication.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Evidence of a nasopharyngeal carcinoma by one or more of the following methods:\r\n             endoscopic examination, imaging, positive nasopharyngeal biopsy or core lymph node\r\n             biopsy staining for Epstein Barr Encoded RNA (EBER) by In Situ Hybridization.\r\n\r\n          -  Prior non-cutaneous head and neck squamous cell carcinoma\r\n\r\n          -  Prior head and neck radiotherapy\r\n\r\n          -  History of neck dissection - contralateral to the side of the nodal disease\r\n\r\n          -  Presence of lymphadenopathy on CT unlikely to originate from a primary oropharyngeal\r\n             carcinoma (i.e., parotid, isolated low (level IV/low level V)\r\n\r\n          -  Radiologically abnormal/enlarged retropharyngeal adenopathy.\r\n\r\n          -  Poor performance status (ECOG status 3 - 5)\r\n\r\n          -  Severe comorbidity or uncontrolled inter-current illness (i.e., unstable angina or\r\n             heart failure in last 6 months, myocardial infarction in last 6 months, chronic\r\n             obstructive pulmonary disease with exacerbations necessitating hospitalization or\r\n             emergency room visit in the past 3 months, history of pneumonia in the past 3 months,\r\n             use of home oxygen, uncorrectable coagulopathy)\r\n\r\n          -  Not a surgical candidate\r\n\r\n          -  Pregnancy\r\n      ","sponsor":"University Health Network, Toronto","sponsor_type":"Other","conditions":"Head and Neck Squamous Cell Carcinoma","interventions":[{"intervention_type":"Other","name":"Other: da Vinci Surgical System Model IS4000","description":"tailored radiotherapy regimen following transoral robotic surgery"}],"outcomes":[{"outcome_type":"primary","measure":"Determination of the rate of out-of-field failures following treatment","time_frame":"2 years","description":"The primary outcome for the study is to determine the rate of out-of-field failures following treatment as determined by use of morphologic imaging (contrast enhanced CT or MRI of the head) and confirmed by biopsy."},{"outcome_type":"secondary","measure":"Adverse Events (AE) monitoring","time_frame":"2 years","description":"To determine the profile of TORS related complications and Surgical Adverse Events within 30 days of surgery using National Cancer Institute Common Terminology Criteria (CTC) for Adverse Events (NCI CTC-AE v 4.0)"},{"outcome_type":"secondary","measure":"Determination of proportions of occult oropharyngeal cancers identified","time_frame":"2 years","description":"To determine the proportion of patients with occult oropharyngeal cancers identified"},{"outcome_type":"secondary","measure":"Location of primary tumours identified through enumeration of patients in each identified site group","time_frame":"2 years","description":"To determine the location of primary tumours identified through enumeration of patients in each identified site group. The study data will be sorted by location of primary tumour and the proportions for each location calculated"},{"outcome_type":"secondary","measure":"Determination of the proportion of patients with completely resected primary tumours","time_frame":"2 years","description":"To determine the location of primary tumours identified, the proportion of patients with primary oropharyngeal carcinomas completely resected (with negative margins), and the proportion of patients amenable to de-intensification treatment (ie, patients who receive no radiotherapy to the primary site and/or unilateral neck radiotherapy)."},{"outcome_type":"secondary","measure":"Determination of the proportion of patients patients amenable to de-intensification treatment","time_frame":"2 years","description":"Determination of the proportion of patients patients amenable to de-intensification treatment"},{"outcome_type":"secondary","measure":"Exploration of expert rated swallowing impairment","time_frame":"2 years","description":"To explore expert rated swallowing impairment on video fluoroscopic swallow studies (VFSS) using the Modified Barium Swallow Impairment (MBS-Imp)instrument tool 2 years"},{"outcome_type":"secondary","measure":"Exploration of patient reported swallowing related quality of life","time_frame":"2 years","description":"To explore patient reported swallowing related quality of life using the MD Anderson Dysphagia Inventory (MDADI)"},{"outcome_type":"secondary","measure":"Exploration of speech and swallowing performance status","time_frame":"2 years","description":"To explore observer rated speech and swallowing using the Performance Status Scale for Head and Neck (PSS-HN) instrument"},{"outcome_type":"secondary","measure":"Exploration of patient reported neck impairment","time_frame":"2 years","description":"To explore patient reported neck impairment using the Neck Dissection Impairment Index (NDII) instrument"},{"outcome_type":"secondary","measure":"Determination of patterns of failure by location","time_frame":"2 years","description":"To determine patterns of failure by location (local, regional, distant) as determined by CT/MRI of the Head and Neck and/or biopsy."},{"outcome_type":"secondary","measure":"Rates of survival after treatment","time_frame":"2 years","description":"To determine rates of survival at 2 years"}]}
{"nct_id":"NCT03626805","start_date":"2017-08-13","enrollment":146,"brief_title":"Muscle Tenderness and Hardness in Migraine Patients","official_title":"Muscle Tenderness and Hardness in Migraine Patients","primary_completion_date":"2018-12-18","study_type":"Observational","rec_status":"Completed","completion_date":"2018-12-18","last_update":"2019-05-29","description":"The aim of the study is to examine symptomatology, quantitative sensory test (QST) parameters, muscle tenderness and muscle hardness in migraine patients interictally and compare with healthy controls","other_id":"001","observational_model":"Case-Control","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":65,"population":"Migraine patients are recruited from the out-patient clinic at the Danish Headache Center.\r\n\r\n        Healthy controls are recruited through web-sites.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Migraine Patients from the Danish Headache Centre. Migraine classified using the\r\n             International Classification of Headache Disorders (ICHD3) criteria.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnant or lactating women\r\n\r\n          -  Musculoskeletal injuries in the neck or shoulder\r\n\r\n          -  Other primary headache disorders than migraine or Tension Type Headache\r\n\r\n          -  On the time of examination: Migraine free for at least 48 hours\r\n\r\n          -  On the time of examination: haven't trained the upper body for at least 48 hours\r\n\r\n          -  On the time of examination: haven't used painkillers for at least 48 hours\r\n\r\n        Healthy controls:\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnant or lactating women\r\n\r\n          -  Musculoskeletal injuries in the neck or shoulder\r\n\r\n          -  Migraine disorders\r\n\r\n          -  1. degree relatives with migraine disorders\r\n\r\n          -  Over 1 day of tension type headache a month.\r\n\r\n          -  On the time of examination: haven't trained the upper body for at least 48 hours\r\n\r\n          -  On the time of examination: haven't used painkillers for at least 48 hours\r\n      ","sponsor":"Danish Headache Center","sponsor_type":"Other","conditions":"Migraine Disorders|Muscle Tenderness|Headache Disorders, Primary|Nervous System Diseases|Headache, Migraine","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Logistic regression model, Neck Stiffness","time_frame":"3 hours","description":"We would like to examine the relationship between the variable variable: Neck stiffness during migraine attack (Yes/No) and the Independent variables: Total Tenderness Score (summed score from 8 points bilateral, each point can score 0-3), Migraine localisation (occipital: Yes/No), Tension Type Headache, Allodynia (yes/No), Stimulus response curve (Pressure and Pain).\r\nThe result shows how much of the variability in neck stiffness that can be explained by the independent variables."},{"outcome_type":"primary","measure":"Pericranial Muscle Tenderness","time_frame":"3 hours","description":"We will examine whether patients with neck stiffness during migraine attack (yes/no) have higher tenderness scores compared to patients without neck stiffness during migraine attacks, when correcting for headache frequency."},{"outcome_type":"primary","measure":"Muscle Hardness measured by ultrasound elastography","time_frame":"3 hours","description":"Muscle hardness (m/s) in migraine patients compared to healthy controls.corrected for age, BMI and sex"},{"outcome_type":"primary","measure":"Muscle hardness measured by ultrasound elastography in migaine patients","time_frame":"3 hours","description":"Muscle hardness (m/s) in migraine patients with neck stiffness during migraine attacks compared to migraine patients without neck stiffness during migraine attacks. Corrected for age, BMI and sex."},{"outcome_type":"secondary","measure":"Multiple Regression model, Total Tenderness Score","time_frame":"3 hours","description":"We would like to examine the relationship between the dependent variable: Total Tenderness Score(summed score from 8 points bilateral, each point can score 0-3), and the Independent variables: Neck Pain in general(Yes/No), Migraine localisation (occipital: Yes/No), Headache Frequency(days/month), Allodynia (Yes/No), Years with Migraine(Number of years)"},{"outcome_type":"secondary","measure":"Logistic regression model, Neck pain in general","time_frame":"3 hours","description":"We would like to examine the relationship between the variable variable: Neck pain in general (Yes/No) and the independent variables: Tension Type Headache(yes/no), Migraine localisation, Headache Frequency(Headache days/month), Allodynia(yes/No), Years with Migraine(number of years)"},{"outcome_type":"secondary","measure":"Next migraine attack, Cox proportional hazards model","time_frame":"3 hours","description":"Using the prospective diary, we will examine the relationship between pericranial muscle tenderness and the next migraine attack, when correcting for headache frequency"},{"outcome_type":"other","measure":"Correlation analysis of muscle hardness and headache frequency","time_frame":"3 hours","description":"Muscle hardness will be measured with ultrasound elastography. Headache frequency is self-reported"},{"outcome_type":"other","measure":"Correlation analysis of muscle hardness and muscle tenderness assessed with the total tenderness score.","time_frame":"3 hours","description":"Muscle hardness will be measured with ultrasound elastography."},{"outcome_type":"other","measure":"Correlation analysis of muscle hardness and pressure pain threshold assessed with an pressure algometer.","time_frame":"3 hours","description":"Muscle hardness will be measured with ultrasound elastography"}]}
{"nct_id":"NCT03224871","start_date":"2017-08-11","phase":"Early Phase 1","enrollment":3,"brief_title":"UCDCC#269: A Pilot Study of Interlesional IL-2 and RT in Patients With NSCLC.","official_title":"UCDCC#269: A Pilot Study of Interlesional IL-2 and Hypofractionated Radiotherapy in Patients With Metastatic Non-small Cell Lung Cancer Who Are Refractory to PD 1 / PD L1 Blockade.","primary_completion_date":"2020-01-10","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-01-10","last_update":"2020-04-07","description":"The advent of checkpoint blockade immunotherapy has revolutionized the management of metastatic non-small cell lung cancer (NSCLC). Despite the promising evidence for deep and durable responses with these agents the majority of patients fail to respond. The investigators hypothesize that a novel strategy combining radiotherapy and intralesional interleukin-2 (IL-2), a signaling molecule and member of the cytokine family involved in the activation of leukocytes and lymphocytes, may overcome resistance to checkpoint blockade therapy and offer significant clinical benefit to patients who fail to respond to checkpoint blockade alone. The investigators propose a microtrial testing the feasibility of a bold combinatorial immunotherapy strategy consisting of radiotherapy (RT), intralesional IL-2, and check-point blockade for metastatic non-small cell lung cancer patients who have progressed after checkpoint inhibition. IL-2 can upregulate PD-1 expression and activate T-cells.","other_id":"1032095","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"All patients will go through the same process except that some patients will be on nivolumab as checkpoint blockade and some patients will be on pembrolizumab as checkpoint blockade.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Adults 18 years of age with histologically proven NSCLC.\r\n\r\n          2. Failure to respond to standard of care checkpoint blockade therapy or previously\r\n             responding patients who progress on checkpoint blockade therapy.\r\n\r\n          3. ECOG (Eastern Cooperative Oncology Group) performance status score of 0 - 2 (Appendix\r\n             1)\r\n\r\n          4. Presence of a candidate treatment lesion (subcutaneous or nodal lesions are preferable\r\n             but visceral lesions will be considered) accessible and safe for radiotherapy and\r\n             serial intralesional injections.\r\n\r\n          5. Presence of at least one target lesion (distinct from treatment lesion and outside of\r\n             treatment lesion radiation field) evaluable for response by RECIST 1.1\r\n\r\n          6. Life expectancy  6 months\r\n\r\n          7. The following laboratory results obtained within 14 days of the first study treatment:\r\n\r\n               -  ANC > 1500 cells/ul\r\n\r\n               -  WBC count > 2500/uL\r\n\r\n               -  Lymphocyte count >500/uL\r\n\r\n               -  Platelet count > 100,000/uL\r\n\r\n               -  Hemoglobin > 9 g/dL\r\n\r\n          8. Liver function tests meeting one of the following criteria:\r\n\r\n               -  AST and ALT < 2.5 x ULN with alkaline phosphatase < 2.5 x ULN OR\r\n\r\n               -  AST and ALT < 1.5 x ULN, with alkaline phosphatase > 2.5 x ULN\r\n\r\n          9. Serum bilirubin  1.0 x ULN.\r\n\r\n         10. INR and aPTT  1.5 x ULN.\r\n\r\n         11. Creatinine clearance > 30 mL/min by Cockcroft-Gault formula.\r\n\r\n         12. No other active malignancy.\r\n\r\n         13. For female patients of childbearing potential and male patients with partners of\r\n             childbearing potential agreement (by patient and/or partner) to use highly effective\r\n             form(s) of contraception (i.e., one that results in a low failure rate [<1% per year]\r\n             when used consistently and correctly) and to continue its use for 6 months after trial\r\n             completion.\r\n\r\n         14. Signed informed consent.\r\n\r\n         15. Ability to comply with the protocol.\r\n\r\n         16. Systolic 80.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Uncontrolled concomitant disease.\r\n\r\n          2. History of severe autoimmune disease.\r\n\r\n          3. Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of\r\n             the drug, whichever is shorter, prior to enrollment (with the exception of checkpoint\r\n             blockade therapy).\r\n\r\n          4. Treatment with systemic corticosteroids or other systemic immunosuppressive\r\n             medications within past 4 weeks or 5 half-lives whichever is shorter.\r\n\r\n          5. Pregnant and/or lactating women.\r\n\r\n          6. Patients unable to tolerate checkpoint inhibitor therapy.\r\n\r\n          7. Grade 3 or 4 non-hematological, treatment-related AEs.\r\n      ","sponsor":"University of California, Davis","sponsor_type":"Other","conditions":"METASTATIC NON-SMALL CELL LUNG CANCER","interventions":[{"intervention_type":"Drug","name":"Drug: Intralesional IL-2","description":"High dose IL-2 (HD-IL-2) is a cytokine produced endogenously by activated T cells and is effective in the treatment of a variety of malignancies because it has both immune-modulating and antitumor properties. In an attempt to take advantage of the robust immune activating effects of IL-2 but avoid the toxicity of high dose systemic IL-2 we and others have investigated the use of intralesional IL-2 injections."},{"intervention_type":"Drug","name":"Drug: Nivolumab","description":"Nivolumab is a fully humanized IgG4 PD-1 blocking antibody which has shown promising efficacy as an immune checkpoint inhibitor in lung cancer. Immune checkpoint blockade will be started on week 1 day 1, concurrent with radiotherapy and continue with cycles every 2 weeks for patients on Nivolumab."},{"intervention_type":"Drug","name":"Drug: Pembrolizumab","description":"PD-1 inhibitor. Immune checkpoint blockade will be started on week 1 day 1, concurrent with radiotherapy and continue with cycles every 3 weeks for patients on Pembrolizumab."},{"intervention_type":"Radiation","name":"Radiation: Radiotherapy","description":"Radiotherapy will be delivered to the treatment lesion during the first week of therapy using an 8 Gy x 3 fractions palliative regimen. Fractions may be delivered on consecutive or every other day but must be completed during week 1 and will not be repeated in future cycles."}],"outcomes":[{"outcome_type":"primary","measure":"Dose limiting toxicity (DLT)","time_frame":"Beginning of treatment to up to 12 months after beginning of treatment.","description":"A dose limiting toxicity (DLT) will be defined as a treatment related grade 3-4 non-hematologic toxicity and will require dose de-escalation. If a DLT does not resolve within 5 days, is not responsive to management, or occurs at the lowest dose level (1 million IU IL-2) after de-escalation then that patient will be removed from trial and the therapy will be deemed intolerable. Therapy will be deemed safe and tolerable if no greater than 33% of patients find the treatment intolerable."},{"outcome_type":"secondary","measure":"Disease free survival","time_frame":"Beginning of treatment to up to 12 months after beginning of treatment.","description":"Disease free survival will be summarized with Kaplan-Meier plots to describe the outcome of patients treated on this protocol. The median DFS time will be estimated using standard life table methods."}]}
{"nct_id":"NCT03136055","start_date":"2017-08-10","phase":"Phase 2","enrollment":36,"brief_title":"Pembrolizumab-based Therapy in Previously Treated High Grade Neuroendocrine Carcinomas","official_title":"A Pilot Study of Pembrolizumab-based Therapy in Previously Treated High Grade Neuroendocrine Carcinomas","primary_completion_date":"2022-09-30","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2023-05-31","last_update":"2021-07-12","description":"This is a pilot study of pembrolizumab-based therapy in previously treated extrapulmonary poorly differentiated neuroendocrine carcinoma","other_id":"169524","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Adaptive Simon's two-stage design is used. The overall design hinges on the activity of single agent pembrolizumab in the first stage of Part A. If there is sufficient activity in the first stage of Part A, the study will expand to the second stage of Part A and forgo Part B. If there is insufficient activity in the first stage of Part A, the study will proceed to the first stage of Part B (pembrolizumab plus chemotherapy).","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Be willing and able to provide written informed consent for the trial.\r\n\r\n          2. Be at least 18 years of age on day of signing informed consent.\r\n\r\n          3. Have a histologically proven locally advanced or metastatic high grade (G3) poorly\r\n             differentiated neuroendocrine carcinoma (NEC).\r\n\r\n               1. Includes small cell and large cell neuroendocrine carcinoma of unknown primary or\r\n                  any extrapulmonary site (and poorly differentiated NEC, not otherwise specified)\r\n\r\n               2. Includes neuroendocrine prostate cancer (de novo or treatment-emergent) of\r\n                  prostate if small cell or large cell histology (histologic evidence of both\r\n                  adenocarcinoma and neuroendocrine carcinoma may be present in same patient).\r\n\r\n               3. Other mixed tumors, e.g. mixed neuroendocrine neoplasms (MINENs) with NEC plus\r\n                  adenocarcinoma, squamous or acinar cell component are allowed if the high grade\r\n                  (small or large cell) NEC component comprises >50% of the original sample or\r\n                  subsequent biopsy.\r\n\r\n          4. Have progressed during or after completion of first line systemic chemotherapy.\r\n\r\n               1. No limit to the number of prior chemotherapy regimens.\r\n\r\n               2. Early progression on/after adjuvant chemotherapy counts as firstline therapy.\r\n\r\n          5. Have at least one measurable disease based on RECIST 1.1.\r\n\r\n          6. Patients must agree to have a biopsy of primary tumor or metastatic tissue at\r\n             baseline, and there must be a lesion that can be biopsied with acceptable clinical\r\n             risk (as judged by the investigator).\r\n\r\n               1. Patients with unsuccessful baseline biopsies may undergo an additional biopsy\r\n                  attempt (at the same or a different site, determined by the investigator).\r\n\r\n               2. For patients with an intact primary and no metastatic site that can be safely\r\n                  biopsied, biopsy of the primary is acceptable, but must be approved by the\r\n                  principal investigator.\r\n\r\n               3. Baseline tumor biopsy may be omitted if the tumor is inaccessible and/or a biopsy\r\n                  is not thought to post exceptionally high procedural risk due to location or\r\n                  other factors\r\n\r\n          7. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)\r\n             Performance Scale.\r\n\r\n          8. Have a life expectancy of greater than 3 months.\r\n\r\n          9. Demonstrate adequate organ function, all screening labs should be performed within 14\r\n             days of treatment initiation.\r\n\r\n               -  Absolute neutrophil count (ANC) >=1,500 /microliter (mcL)\r\n\r\n               -  Platelets >=100,000 / mcL\r\n\r\n               -  Hemoglobin >= 9 g/dL or >=5.6 mmol/L without transfusion or erythropoietin (EPO)\r\n                  dependency (within 7 days of assessment)\r\n\r\n               -  Serum creatinine OR Measured or calculated creatinine clearance (CrCl)\r\n                  (Creatinine clearance should be calculated per institutional standard. Glomerular\r\n                  filtration rate (GFR) can also be used in place of creatinine or CrCl <=1.5 X\r\n                  upper limit of normal (ULN) OR >=60 mL/min for subject with creatinine levels >\r\n                  1.5 X institutional ULN\r\n\r\n               -  Serum total bilirubin <= 1.5 X ULN OR Direct bilirubin <= ULN for subjects with\r\n                  total bilirubin levels > 1.5 ULN\r\n\r\n               -  aspartate aminotransferase (AST) / serum glutamic-oxaloacetic transaminase (SGOT)\r\n                  and alanine aminotransferase (ALT)/ serum glutamic-pyruvic transaminase (SGPT)\r\n                  <=2.5 X ULN OR  5 X ULN for subjects with liver metastases\r\n\r\n               -  Albumin >2.5 g/dL\r\n\r\n               -  International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial\r\n                  Thromboplastin Time (aPTT) <=1.5 X ULN unless subject is receiving anticoagulant\r\n                  therapy as long as PT or PTT is within therapeutic range of intended use of\r\n                  anticoagulants.\r\n\r\n         10. Female subject of childbearing potential should have a negative urine or serum\r\n             pregnancy within 72 hours prior to receiving the first dose of study medication. If\r\n             the urine test is positive or cannot be confirmed as negative, a serum pregnancy test\r\n             will be required.\r\n\r\n         11. Female subjects of childbearing potential should be willing to use 2 methods of birth\r\n             control or be surgically sterile, or abstain from heterosexual activity for the course\r\n             of the study through 120 days after the last dose of study medication. Subjects of\r\n             childbearing potential are those who have not been surgically sterilized or have not\r\n             been free from menses for > 1 year.\r\n\r\n               -  Male subjects should agree to use an adequate method of contraception starting\r\n                  with the first dose of study therapy through 120 days after the last dose of\r\n                  study therapy.\r\n\r\n               -  Note: Abstinence is acceptable if this is the usual lifestyle and preferred\r\n                  contraception for the subject.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Has Merkel cell carcinoma, small cell lung carcinoma, or large cell NEC of lung\r\n\r\n               -  Intermediate grade neuroendocrine tumors are excluded\r\n\r\n               -  Well differentiated Grade 3 neuroendocrine tumors are excluded\r\n\r\n               -  Metastatic high-grade prostate carcinoma with evidence of focal neuroendocrine\r\n                  differentiation on prostate biopsy (e.g., positive chromogranin staining by\r\n                  immunohistochemistry) without small cell or large cell NEC morphology are\r\n                  excluded, as are neuroendocrine prostate cancers with phenotype intermediate\r\n                  between adenocarcinoma and small cell\r\n\r\n               -  Atypical and typical bronchial carcinoids and well differentiated G1 and G2\r\n                  gastroenteropancreatic (GEP) neuroendocrine tumors (NET) (GEP NETs) are excluded.\r\n\r\n          2. Is currently participating and receiving study therapy or has participated in a study\r\n             of an investigational agent and received study therapy or used an investigational\r\n             device within 4 weeks of the first dose of treatment.\r\n\r\n          3. Has a diagnosis of immunodeficiency\r\n\r\n          4. Is receiving systemic steroid therapy or any other form of immunosuppressive therapy\r\n             within 7 days prior to the first dose of trial treatment.\r\n\r\n             - Physiologic doses of steroids (e.g. =< 10 mg prednisone/day or equivalent) are\r\n             allowed\r\n\r\n          5. Has a known history of active Bacillus Tuberculosis (TB).\r\n\r\n          6. History of or high suspicion of Gilbert's disease (safety run-in, Part B only)\r\n\r\n          7. Hypersensitivity to pembrolizumab or any of its excipients.\r\n\r\n          8. Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study\r\n             Day 1 or who has not recovered (i.e.,  Grade 1 or at baseline) from adverse events\r\n             due to agents administered more than 4 weeks earlier.\r\n\r\n          9. Documented progression on and/or intolerance/hypersensitivity to both paclitaxel and\r\n             irinotecan (Part B only)\r\n\r\n         10. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy\r\n             within 2 weeks prior to study Day 1 or who has not recovered (i.e., <= Grade 1 or at\r\n             baseline) from adverse events due to a previously administered agent.\r\n\r\n               -  Note: Subjects with  Grade 2 neuropathy are an exception to this criterion and\r\n                  may qualify for the study.\r\n\r\n               -  Note: If subject received major surgery, they must have recovered adequately from\r\n                  the toxicity and/or complications from the intervention prior to starting\r\n                  therapy.\r\n\r\n               -  Concurrent somatostatin analog therapy is allowed (for control of hormone excess)\r\n                  provided patient has been on stable dose for at least two months and tumor\r\n                  progression has been documented\r\n\r\n               -  Continuation of androgen deprivation therapy (ADT) allowed for patients with\r\n                  neuroendocrine prostate cancer (in the setting of castration-resistant prostate\r\n                  cancer, CRPC)\r\n\r\n         11. Has a known additional malignancy that is progressing or requires active treatment.\r\n             Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the\r\n             skin that has undergone potentially curative therapy or in situ cervical cancer.\r\n\r\n         12. Has known active central nervous system (CNS) metastases and/or carcinomatous\r\n             meningitis. Patients with asymptomatic suspected brain metastases (or small lesions of\r\n             uncertain significance) <1 cm that do not require focal therapy are eligible. (Follow\r\n             up imaging will be allowed on study, and focal radiation with continuation of protocol\r\n             therapy allowed if there is progressive disease in the brain and systemic imaging\r\n             shows stable disease/response).\r\n\r\n             - Subjects with previously treated brain metastases may participate provided they are\r\n             stable (without evidence of progression by imaging for at least four weeks and any\r\n             neurologic symptoms have returned to baseline), they have no evidence of new or\r\n             enlarging brain metastases (confirmed by imaging within 28 d of the first dose of\r\n             trial treatment), and they are not using steroids for at least 7 days prior to trial\r\n             treatment. This exception does not include carcinomatous meningitis, which is excluded\r\n             regardless of clinical stability.\r\n\r\n         13. Has active autoimmune disease that has required systemic treatment in the past 2 years\r\n             (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive\r\n             drugs).\r\n\r\n             - Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid\r\n             replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a\r\n             form of systemic treatment.\r\n\r\n         14. Has a history of (non-infectious) pneumonitis/ interstitial lung disease that required\r\n             steroids or has current pneumonitis/interstitial lung disease.\r\n\r\n         15. Has an active infection requiring systemic therapy.\r\n\r\n         16. Has a history or current evidence of any condition, therapy, or laboratory abnormality\r\n             that might confound the results of the trial, interfere with the subject's\r\n             participation for the full duration of the trial, or is not in the best interest of\r\n             the subject to participate, in the opinion of the treating investigator.\r\n\r\n         17. Has known psychiatric or substance abuse disorders that would interfere with\r\n             cooperation with the requirements of the trial.\r\n\r\n         18. Is pregnant or breastfeeding, or expecting to conceive or father children within the\r\n             projected duration of the trial, starting with the pre-screening or screening visit\r\n             through 120 days after the last dose of trial treatment.\r\n\r\n         19. Has received prior therapy with an anti-Programmed Death 1 (PD-1), anti-Programmed\r\n             Death Ligand 1 (PD-L1), or anti-PD-L2 agent.\r\n\r\n         20. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).\r\n\r\n         21. Has known active Hepatitis B virus (e.g., HBsAg reactive) or Hepatitis C virus\r\n             (HCV)(e.g., HCV RNA [qualitative] is detected).\r\n\r\n         22. Has received a live vaccine or live-attenuated vaccine within 30 days prior to the\r\n             first dose of study drug. Administration of killed vaccines is allowed.\r\n      ","sponsor":"University of California, San Francisco","sponsor_type":"Other","conditions":"High Grade Malignant Neuroendocrine Carcinoma (Diagnosis)","interventions":[{"intervention_type":"Drug","name":"Drug: Pembrolizumab","description":"200 mg every 3 weeks via IV infusion."},{"intervention_type":"Drug","name":"Drug: Irinotecan","description":"For patients in part B receiving pembrolizumab and chemotherapy with irinotecan. The starting dose for the safety lead-in is 125 mg/m2 irinotecan via IV infusion in a 2 weeks on, 1 week off format over 3 week cycles.\r\nIf the initial dose is not tolerated, the dose level will be decreased to 100 mg/m2."},{"intervention_type":"Drug","name":"Drug: Paclitaxel","description":"For patients in part B receiving pembrolizumab and chemotherapy with paclitaxel. Patients will receive 80 mg/m2 of paclitaxel via IV infusion every week, with treatment breaks as needed."}],"outcomes":[{"outcome_type":"primary","measure":"Overall Response Rate (ORR)","time_frame":"Approximately 2 years","description":"ORR is defined as the proportion of the subjects in the analysis population who demonstrated complete response (CR) or partial response (PR) radiographically according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by investigator. The analysis will include all subjects treated (ITT) who received at least one dose of the study treatment. If the final study consists of both Part A and Part B, the analysis will be done separately for each part."},{"outcome_type":"secondary","measure":"Overall Survival (OS)","time_frame":"Over the duration of the study, which is estimated to be approximately 32 months.","description":"Overall survival is defined as the time from the first day of study treatment with protocol therapy to the date of death due to any cause. Kaplan-Meier method will be used to summarize OS. Median OS and its 95% confidence interval will be obtained for Part A and B (if available) separately."},{"outcome_type":"secondary","measure":"Duration of Response (DOR)","time_frame":"Over the duration of the study, which is estimated to be approximately 32 months.","description":"Duration of Response is defined as the time from the date of first response (CR or PR) until the date of disease progression or death. Kaplan-Meier method will be used to summarize DOR. Median DOR and its 95% confidence interval will be obtained for Part A and B (if available) separately. Only patients who have a demonstrated response will be used in final analysis."},{"outcome_type":"secondary","measure":"Progression free survival (PFS)","time_frame":"Over the duration of the study, which is estimated to be approximately 32 months.","description":"Progression free survival is defined as the time from the first day of study treatment with protocol therapy to the date of documented tumor progression or death due to any cause, whichever occurs first, as determined by The immune-related response criteria (irRC) for the immune-related progression-free survival (irPFS) and RECIST v1.1 for PFS. Subjects who did not progress or die will be censored on the date of their last evaluable tumor assessment. Kaplan-Meier method will be used to summarize progression free survival; median irPFS and PFS will be estimated with 95% confidence interval for Part A and B (if available) separately."}]}
{"nct_id":"NCT03347942","start_date":"2017-08-10","phase":"N/A","enrollment":110,"brief_title":"Effects of the Administered Time of Meal on the Treatment of Overweight and Obesity","official_title":"Clinical Study Randomized of the Effects of the Administered Time of Meal on the Treatment of Overweight and Obesity","primary_completion_date":"2017-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2018-07-31","last_update":"2017-11-20","description":"Objectives: To evaluate the impact of the meal time administered on the body weight of adult individuals of both sexes, being overweight and obese. Experimental design: randomized controlled trial. Place of research: Hospital de Clnicas de Porto Alegre, Porto Alegre, RS, Brazil. Materials and methods: Anthropometric data, blood pressure, waist diameter will be measured; venous blood samples will be collected and stored for glucose, total cholesterol, triglycerides, HDL-cholesterol, urea, creatinine and ALT in serum. Intervention: Wait at least 20 minutes after finishing the first portion of meals, previously considered sufficient by the individual before serving again. The control group will also serve the dish the same way, but you can serve additional portion without waiting. Measurements: P values less than 0.05 will be considered statistically significant. Expected results: Weight loss, decrease in anthropometric markers and risk factors for cardiovascular diseases.","other_id":"16-0327","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","intervention_model_description":"Randomized and controlled clinical trial in adults of both sexes, overweight and obese who accepted to participate in the research at the Hospital de Clnicas in the city of Porto Alegre. Individuals will be divided into two paired groups for age, gender and waist diameter. These two groups will be randomized by lottery.","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":59,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Overweight and obesity grade I, according to WHO criteria (1998).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Normal weight, obesity> grade I;\r\n\r\n          -  Use of appetite-enhancing medications such as glucocorticoids, tricyclic\r\n             antidepressants, antipsychotics, mood modulators and anticonvulsants, or reduce body\r\n             weight , such as anorexigenics, and antidiabetics that can modify body weight;\r\n\r\n          -  In follow-up or nutritional intervention already established and;\r\n\r\n          -  Refusal to sign the informed consent form.\r\n      ","sponsor":"Hospital de Clinicas de Porto Alegre","sponsor_type":"Other","conditions":"Feeding Behavior|Diet, Reducing|Eating","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Intervention group","description":"Wait at least 20 minutes after finishing the first portion of meals previously considered sufficient by the individual before serving again if he or she feels the need. The intervention time will be monitored by the participants themselves, who will be instructed by the researcher when the methodology to be performed."},{"intervention_type":"Other","name":"Other: Control group","description":"The control group will also serve the dish of the form, but can serve additional portion without waiting."}],"outcomes":[{"outcome_type":"primary","measure":"Mean body weight","time_frame":"30 days","description":"Measurement of body weight in kilograms - will be carried out on the balance of Toledo® brand with a capacity of 200 kg, after urinating.\r\nThe individual will keep his body erect, with arms hanging over the body and heels attached.\r\nParticipants should only be in their underwear and disposable surgical dress, barefoot."},{"outcome_type":"secondary","measure":"Cardiovascular risk assessment scores","time_frame":"30 days","description":"The calculation will be done with the CV Risk Calculator tool of the American College of Cardiology and the American Cardiology Association to obtain the percentage (%) risk for acute myocardial infarction or stroke in ten years."},{"outcome_type":"secondary","measure":"Waist diameter values","time_frame":"30 days","description":"It will be obtained with flexible tape and inelastic (in centimeters), with the individual standing erect, arms extended along the body and feet together.\r\nThe tape will be positioned at the midpoint between the iliac crest and the outer side of the last rib."}]}
{"nct_id":"NCT03151798","start_date":"2017-08-09","phase":"N/A","enrollment":90,"brief_title":"The Liver Health Study for Patients With NAFLD","official_title":"Nutrient Overload, Insulin Resistance, and Hepatic Mitochondrial Dysfunction","primary_completion_date":"2022-04-29","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-04-29","last_update":"2020-03-12","description":"The study will investigate whether the level of fat stored in the liver is related to the liver's ability to burn fat.","other_id":"HS IRB #2008258","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","intervention_model_description":"In Phase I, liver samples derived from patients undergoing either bariatric surgery or a liver biopsy to diagnose nonalcoholic fatty liver disease, are tested one time in vitro. There is no treatment in Phase I.\r\nIn Phase II, only patients with nonalcoholic fatty liver disease (and not those who have had bariatric surgery) are eligible to go into a study in which they are randomly assigned to 1) a lifestyle treatment program or 2) a control group undergoing standard care. Allocation is 2:1 subjects in the treatment vs standard care groups.\r\nThus, the arms are:\r\nArm 1: Phase I studies with no treatment, only observational data generated in vitro from the liver samples Arm 2: Phase II lifestyle treatment Arm 3: Phase II control standard of care","sampling_method":"","gender":"All","minimum_age":22,"maximum_age":65,"population":"","criteria":"\n        For Phase I: Any patient scheduled to undergo bariatric surgery or a liver biopsy to\r\n        diagnose nonalcoholic fatty liver disease.\r\n\r\n        For Phase II: Only subjects who have had a diagnosis of nonalcoholic fatty liver disease\r\n        and completed Phase I (and no subjects who have undergone bariatric surgery)\r\n\r\n        Inclusion Criteria:\r\n\r\n          1. Men and women (pre and post-menopausal)\r\n\r\n          2. Overweight/obese with BMI  25.9 or < 50.0 kg/m2\r\n\r\n          3. Characteristics of the metabolic syndrome, pre-diabetes (fasting glucose 100-125 mg/dL\r\n             or 2h glucose 140-200 mg/dL) or diabetes type 2, or undergoing bariatric surgery\r\n\r\n          4. 22-65 years of age\r\n\r\n          5. Sedentary, < 60 minutes per week of structured physical activity\r\n\r\n          6. Alcohol intake< 20 g/d\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Having undergone bariatric surgery.\r\n\r\n          2. Acute disease or advanced cardiac or renal disease, anticoagulation therapy, or any\r\n             severe co-morbid condition limiting life expectancy < 1 years\r\n\r\n          3. Other causes of hepatitis including hepatitis B & C, autoimmune hepatitis,\r\n             hemochromatosis, celiac disease, Wilson's disease, alpha-1-antitrypsin deficiency,\r\n             medication-induced hepatitis, any clinical or biochemical evidence of decompensated\r\n             liver disease\r\n\r\n          4. Use of steroids or other drugs that cause NAFLD\r\n\r\n          5. Pregnant or trying to become pregnant\r\n\r\n          6. Inability to exercise on a bike or treadmill\r\n      ","sponsor":"University of Missouri-Columbia","sponsor_type":"Other","conditions":"Nonalcoholic Fatty Liver|Nonalcoholic Steatohepatitis|Obesity","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Phase II: Lifestyle treatment","description":"Subjects will undergo energy restriction and exercise training over a 9 month period."},{"intervention_type":"Behavioral","name":"Behavioral: Phase II: Control treatment","description":"Subjects will receive dietary advice and receive information on a stretching program."},{"intervention_type":"Other","name":"Other: Phase I: Observational studies","description":"The liver samples from patients undergoing bariatric surgery or a diagnostic liver biopsy will undergo in vitro assays to determine the capacity of the tissue to burn fat"}],"outcomes":[{"outcome_type":"primary","measure":"Liver mitochondrial gene expression","time_frame":"1 day","description":"Liver tissue will be tested in vitro to determine the abundance of transcript indicative of fat oxidation."},{"outcome_type":"secondary","measure":"Liver mitochondrial fat oxidation","time_frame":"1 day","description":"Liver tissue will be tested in vitro to determine its capacity to burn fat"},{"outcome_type":"secondary","measure":"Histology to determine the amount of fibrosis in the liver","time_frame":"1 day","description":"Liver samples will be tested to determine the severity of liver disease and whether diet and exercise reduce liver fibrosis."}]}
{"nct_id":"NCT03234296","start_date":"2017-08-09","phase":"N/A","enrollment":147,"brief_title":"Antibiotics vs. Placebo in Acute Uncomplicated Appendicitis","official_title":"Antibiotic Therapy vs. Placebo in the Treatment of Acute Uncomplicated Appendicitis: a Randomized Double-blinded Placebo-controlled Trial - APPAC III Study","primary_completion_date":"2020-09-15","study_type":"Interventional","rec_status":"Enrolling by invitation","completion_date":"2029-08-30","last_update":"2020-11-10","description":"Appendicectomy has been the treatment of acute appendicitis for over a hundred years. Appendicectomy, however, includes operative and postoperative risks despite being a \"routine\" operation. At the same time other similar intra-abdominal infections, such as diverticulitis, are treated with antibiotics. Several studies have proved promising results of the safety and efficiency of antibiotics in the treatment of acute uncomplicated appendicitis. Our previous APPAC study, published in 2015 in the Journal of American Medical Association, also proved promising results with 73% of patients with CT-diagnosed uncomplicated appendicitis treated successfully with antibiotics within one-year follow-up. None of the patients initially treated with antibiotics that later had appendectomy had major complications. The results of the APPAC trial suggest that CT proven uncomplicated acute appendicitis is not a surgical emergency and antibiotic therapy is a safe first-line treatment option. Reducing unnecessary appendectomies has also been shown to lead to significant economic savings. Already in 1886 Fitz noted that 1/3 of patients in a large series of autopsies from the pre-appendicectomy era had evidence of prior appendices inflammation suggesting spontaneous resolution of acute appendicitis. Acute appendicitis is thought to be similar to acute diverticulitis (\"left-sided appendicitis\") and this similarity has been shown in epidemiological studies. Recent studies have shown no benefit of antibiotic treatment in the treatment of uncomplicated diverticulitis with outpatient management without antibiotics proving safe and well-functioning. The aim of this randomised double-blinded study is to compare antibiotic therapy with placebo to evaluate the role of antibiotic therapy in the resolution of CT-diagnosed uncomplicated acute appendicitis. The hypothesis is that antibiotic therapy is necessary in the treatment of acute uncomplicated appendicitis and that antibiotic therapy is superior to spontaneous resolution (placebo) with the primary endpoint evaluated at ten days after the intervention.","other_id":"APPAC III","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","intervention_model_description":"Anticipated enrollment delays > three alternate scenarios for sample size calculations, please see prtocol for details.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age between 18-60 years\r\n\r\n          -  CT confirmed uncomplicated acute appendicitis\r\n\r\n          -  Ability to give informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Age under 18 or over 60 years\r\n\r\n          -  Pregnancy or lactation\r\n\r\n          -  Allergy to contrast media or iodine\r\n\r\n          -  Allergy or contraindication to antibiotic therapy\r\n\r\n          -  Metformin medication\r\n\r\n          -  Renal insufficiency\r\n\r\n          -  Severe systemic illness (for example malignancy, medical condition requiring\r\n             immunosuppressant medication)\r\n\r\n          -  Complicated acute appendicitis confirmed by CT scan\r\n\r\n          -  Inability to cooperate or give informed consent\r\n      ","sponsor":"Turku University Hospital","sponsor_type":"Other","conditions":"Acute Appendicitis","interventions":[{"intervention_type":"Drug","name":"Drug: Ertapenem","description":"Intravenous antibiotic followed by per oral antibiotics"},{"intervention_type":"Other","name":"Other: Placebo","description":"Intravenous placebo followed by per oral placebo"}],"outcomes":[{"outcome_type":"primary","measure":"Success of the randomized treatment","time_frame":"10 days after treatment initiation","description":"Resolution of acute appendicitis with study group treatment resulting in discharge from the hospital without the need for surgical intervention and treatment efficacy evaluated at ten days after initiation of the randomized treatment."},{"outcome_type":"secondary","measure":"Late recurrence of appendicitis","time_frame":"10 years","description":"Late recurrence of acute appendicitis after study treatment defined as clear clinical suspicion of acute appendicitis evaluated at follow-up of one, three, five and ten years"},{"outcome_type":"secondary","measure":"Post-intervention complications","time_frame":"10 years","description":"Complications according to the Clavien-Dindo classification"},{"outcome_type":"secondary","measure":"Hospital stay","time_frame":"1 month","description":"Duration of hospital stay in days"},{"outcome_type":"secondary","measure":"VAS score (visual analogue score)","time_frame":"10 years","description":"Pain as defied by the VAS pain score"},{"outcome_type":"secondary","measure":"Sick leave","time_frame":"1 month","description":"Duration of sick leave"},{"outcome_type":"secondary","measure":"Treatment costs","time_frame":"10 years","description":"Costs resulting from laboratory costs, imaging costs, treatments costs, hospital stay, and treatment of complications and possible operative treatment"}]}
{"nct_id":"NCT03271268","start_date":"2017-08-06","enrollment":36,"brief_title":"Cardiovascular Biomarkers and Lung Edema in Severe Burns Patients","official_title":"The Role of CARdiovascular biOmarkers (NT-pro-BNP and CD146) in Predicting Lung Edema in Severely Burned Patients","primary_completion_date":"2019-02-06","study_type":"Observational","rec_status":"Unknown status","completion_date":"2019-04-06","last_update":"2017-09-07","description":"Burn injury leads to hypovolemic then distributive shock. Fluid resuscitation remains the cornerstone of initial treatment of burn shock. However, fluid rescucitation can lead to fluid overload, which manifests most notably as lung edema. The peptide NT-pro-BNP, a biomarker of cardiac congestion secreted by the myocardium, as well as plasma CD146, an endothelial factor involved in angiogenesis and a marker of vascular congestion, may help identifying patients with risk of pulmonary edema and hypoxia . Our hypothesis is that these biomarkers may predict the occurence of pulmonary edema in severe burns patients.","other_id":"StLouisFrance","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Severely ill burn patients admitted to a tertiary referral burn center","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Intubated mechanically-ventilated patients within the first 24 hours of admission\r\n\r\n          -  And/or patients with total body surface area (TBSA) burn-injured >20 %\r\n\r\n          -  And/or patients with at least 10% full-thickness burns\r\n\r\n          -  And/or receiving vasopressors within the first 24 hours of admission\r\n\r\n          -  And monitored by a PiCCO system (PiCCO-2 Pulsion Medical Systems AG, Munich, Germany)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Admission delay to ICU > 24 hours post burn\r\n\r\n          -  Age less than 18 years\r\n\r\n          -  Pregnancy\r\n\r\n          -  Chronic renal impairment with a baseline eGFR < 15 ml/min\r\n\r\n          -  Patients with chemical or electrical burns\r\n\r\n          -  Coexisting non-burn trauma\r\n\r\n          -  Patients moribund on admission or dead within 72 h from admission\r\n\r\n          -  Patients with do-not-resuscitate orders\r\n      ","sponsor":"Saint-Louis Hospital, Paris, France","sponsor_type":"Other","conditions":"Burns","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Lung edema","time_frame":"During the first 7 days of admission","description":"Extravascular lung water (EVLW) > 10 mL/Kg as measured by transpulmonary thermodilution (TPTD)"},{"outcome_type":"secondary","measure":"Hypoxemia","time_frame":"During the first 7 days of admission for mechanically-ventilated patients","description":"PaO2/FiO2 ratio of <200"},{"outcome_type":"secondary","measure":"Hypercapnia","time_frame":"During the first 7 days of admission for mechanically-ventilated patients","description":"PaCO2> 45 mmHg"},{"outcome_type":"secondary","measure":"Corrected minute ventilation > 10L/min","time_frame":"During the first 7 days of admission for mechanically-ventilated patients","description":"Minute ventilation × partial [Paco2]/40) > 10L/min"},{"outcome_type":"secondary","measure":"Multiple organ dysfunction syndrome (MODS)","time_frame":"During the first 7 days of admission","description":"Sequential Organ Failure Assessment score (SOFA) ≥ 8"},{"outcome_type":"secondary","measure":"28-day mortality","time_frame":"28 days"},{"outcome_type":"secondary","measure":"90-day mortality","time_frame":"90 days"},{"outcome_type":"secondary","measure":"Length of stay in the ICU","time_frame":"until 90 days of hospitalization"}]}
{"nct_id":"NCT03188081","start_date":"2017-08-04","enrollment":300,"brief_title":"A Study to Investigate the Effectiveness of an Education Support Program on Medication Adherence in Italian Real Life Rheumatoid Arthritis (RA) Patients Treated With Subcutaneous (SC) Abatacept","official_title":"A Prospective, Multicentric, Observational Study to Investigate the Effectiveness of an Education Support Program on Medication Adherence in Italian Real Life RA Patients Treated With Abatacept SC","primary_completion_date":"2019-08-04","study_type":"Observational","rec_status":"Unknown status","completion_date":"2021-08-04","last_update":"2018-07-12","description":"The primary objective of this study is to investigate whether an Educational Supported Program (ESP), including tight control procedures implemented through patient home care, has positive impact in terms of better adherence to the therapy with abatacept SC at 12 months after treatment start (1st injection). In the scope of this objective the adherence is measured by the Medication Adherence Questionnaire (MAQ).","other_id":"IM101-645","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"Adult RA patients, nave of abatacept, initiated with abatacept SC either as 1st or 2nd\r\n        line biologic treatment after inadequate response to previous therapy with one or more\r\n        Disease-Modifying Anti-Rheumatic Drugs (DMARDs)","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Informed consent to participate in the study signed by the patient\r\n\r\n          -  Age  18 years at the date of consent subscription\r\n\r\n          -  Diagnosis of active Rheumatoid Arthritis moderate to severe as per the 1987 American\r\n             College of Rheumatology (ACR) criteria/2010 ACR/ European League Against Rheumatism\r\n             (EULAR) RA Classification Criteria\r\n\r\n          -  Nave of abatacept\r\n\r\n          -  Initiated with abatacept SC either as 1st or 2nd line biologic treatment after\r\n             inadequate response to previous therapy with one or more DMARDs according to Summary\r\n             of Product Characteristics (SmPC) locally approved\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Participating in clinical trial or other non-interventional studies, excluding\r\n             registries\r\n\r\n          -  Inability to read and write\r\n\r\n          -  Any condition that in the investigator's opinion might jeopardize the follow-up and\r\n             the data collection for the entire study observation period (24 months)\r\n      ","sponsor":"Bristol-Myers Squibb","sponsor_type":"Industry","conditions":"Rheumatoid Arthritis","interventions":[{"intervention_type":"Drug","name":"Drug: Abatacept","description":"Subcutaneous"}],"outcomes":[{"outcome_type":"secondary","measure":"Prior RA treatments","time_frame":"24 months","description":"To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation"},{"outcome_type":"primary","measure":"Change in Medication Adherence Questionnaire (MAQ)","time_frame":"12 months and 24 months","description":"To investigate whether an Educational Support Program (ESP), including tight control procedures implemented through patient home care, has positive impact in terms of better adherence to the therapy with abatacept SC at 12 months and 24 months after treatment start (1st injection)"},{"outcome_type":"primary","measure":"Adherence ratio","time_frame":"24 months","description":"Percentage ratio between the total number of injections taken in a treatment period and the total number of injections expected to be taken in the same treatment period according to rheumatologist prescription"},{"outcome_type":"secondary","measure":"Distribution of socio-demographic data","time_frame":"24 months","description":"To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation"},{"outcome_type":"secondary","measure":"Patient Rheumatoid Arthritis History","time_frame":"24 months","description":"To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation"},{"outcome_type":"secondary","measure":"Co-morbidities","time_frame":"24 months","description":"To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation"},{"outcome_type":"secondary","measure":"Clinical measurements (disease indices and relevant subcomponents)","time_frame":"24 months","description":"To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation"},{"outcome_type":"secondary","measure":"Erythrocyte Sedimentation Rate","time_frame":"24 months","description":"To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation"},{"outcome_type":"secondary","measure":"Rheumatoid Factor","time_frame":"24 months","description":"To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation"},{"outcome_type":"secondary","measure":"Anti Citrullinated Peptide Antibody","time_frame":"24 months","description":"To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation"},{"outcome_type":"secondary","measure":"Patient's reported assessment of health measured by HAQ-DI","time_frame":"24 months","description":"To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation and to investigate whether a better adherence to the abatacept SC therapy is associated to a better health status of the patient population"},{"outcome_type":"secondary","measure":"Health related quality of life measured by EQ-5D","time_frame":"24 months","description":"To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation and to investigate whether a better adherence to the abatacept SC therapy is associated to a better health status of the patient population"},{"outcome_type":"secondary","measure":"Remission rate measured by MAQ","time_frame":"24 months","description":"To investigate whether a better adherence to the abatacept SC therapy is associated to a better clinical outcome of the patient population"},{"outcome_type":"secondary","measure":"Low disease activity rate measured by MAQ","time_frame":"24 months","description":"To investigate whether a better adherence to the abatacept SC therapy is associated to a better clinical outcome of the patient population"},{"outcome_type":"secondary","measure":"DAS28 score measured by MAQ","time_frame":"24 months","description":"To investigate whether a better adherence to the abatacept SC therapy is associated to a better clinical outcome of the patient population"},{"outcome_type":"secondary","measure":"Concomitant medication for RA (Synthetic DMARDs and corticosteroids)","time_frame":"24 months","description":"To describe the use of concomitant medication for RA (Synthetic DMARDs and corticosteroids) over the study observation period"},{"outcome_type":"secondary","measure":"Adverse Events","time_frame":"24 months","description":"To describe the incidence of Adverse Events, by seriousness and relationship with abatacept SC"},{"outcome_type":"secondary","measure":"Reason for Withdrawal, where applicable","time_frame":"24 months","description":"To describe the incidence of the reasons for withdrawal from the treatment and the study"},{"outcome_type":"secondary","measure":"Retention rate","time_frame":"24 months","description":"To evaluate the retention rate calculated as the time-to-discontinuation of abatacept SC treatment over the study observation period"},{"outcome_type":"secondary","measure":"Cost-utility analysis (CUA)","time_frame":"24 months","description":"To perform a cost-utility analysis (CUA) from the National Health System"},{"outcome_type":"secondary","measure":"Societal perspective comparing health consequences","time_frame":"24 months","description":"Societal perspective comparing health consequences Quality Adjusted Life Years (QALYs)"},{"outcome_type":"secondary","measure":"Cost of alternative follow-up strategies","time_frame":"24 months","description":"Two alternative follow-up strategies: ESP versus standard control"},{"outcome_type":"secondary","measure":"Patient's reported assessment of health measured by Pain VAS","time_frame":"24 months","description":"To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation and to investigate whether a better adherence to the abatacept SC therapy is associated to a better health status of the patient population"}]}
{"nct_id":"NCT04026139","start_date":"2017-08-01","phase":"N/A","enrollment":60,"brief_title":"Elastic Band Resistance Exercise on Glycated Haemoglobin and Muscle Strength, Balance, and Physical Function in Patients With Comorbid Type 2 Diabetes Mellitus and Knee Osteoarthritis","official_title":"Elastic Band Resistance Exercise on Glycated Haemoglobin and Muscle Strength, Balance, and Physical Function in Patients With Comorbid Type 2 Diabetes Mellitus and Knee Osteoarthritis","primary_completion_date":"2018-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-01-31","last_update":"2019-07-19","description":"Whether elastic band resistance exercise (EBRE) as a home-based rehabilitation routine can control the glycated heamoglobin (HbA1c) level and improve the muscle strength, dynamic balance, and physical function in older patients with comorbid T2DM and knee OA?","other_id":"201700009B0D001","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","intervention_model_description":"Design: Randomised controlled trial. Participants: Seventy patients diagnosed with T2DM together with knee OA. Intervention: Patients in the experimental and control group were instructed by clinical staff to perform home-based exercises and followed up through phone calls. The experimental group performed exercises using an elastic resistance band with 10 repetitions/set  5 sets/day  3 days/week. The control group underwent active joint range-of-motion exercises and isometric contraction exercises. The intervention regimens lasted 12 weeks.","sampling_method":"","gender":"All","minimum_age":60,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Inclusion criteria for this study were as follows: age between 60 and 70 years;\r\n             comorbid T2DM and knee OA diagnosed by a physician; and Kellgren and Lawrence (K&L)\r\n             grade <3 based on the findings of plain radiographs.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Exclusion criteria were as follows: inability to perform any self-activity; DM with\r\n             complications, such as lower extremity neuropathy, retinopathy, stroke, foot wounds,\r\n             or amputations; K&L grade >3, hip or knee arthroplasty; history of myocardial\r\n             infarction; uncontrolled liver and kidney disease; and uncontrolled hypertension.\r\n      ","sponsor":"Shu-Mei Chen","sponsor_type":"Other","conditions":"Elastic Band Resistance Exercise With Comorbid Type 2 Diabetes Mellitus and Knee Osteoarthritis","interventions":[{"intervention_type":"Other","name":"Other: Elastic Band Resistance Exercise","description":"Patients in the experimental and control group were instructed by clinical staff to perform home-based exercises and followed up through phone calls. The experimental group performed exercises using an elastic resistance band with 10 repetitions/set  5 sets/day  3 days/week."},{"intervention_type":"Other","name":"Other: active joint range-of-motion exercises and isometric contraction exercises","description":"The control group underwent active joint range-of-motion exercises and isometric contraction exercises. The intervention regimens lasted 12 weeks."}],"outcomes":[{"outcome_type":"primary","measure":"HbA1c level","time_frame":"up to 12 weeks of intervention","description":"follow blood glucose cotrol"},{"outcome_type":"primary","measure":"WOMAC physical function subscale scores","time_frame":"up to 12 weeks of intervention","description":"follow osteoarthritis physical function"},{"outcome_type":"primary","measure":"30-s chair stand test [CST]","time_frame":"up to 12 weeks of intervention","description":"follow low leg muscle strength"},{"outcome_type":"primary","measure":"3-m timed up and go test [TUG]","time_frame":"up to 12 weeks of intervention","description":"follow dynamic balance"}]}
{"nct_id":"NCT03160131","start_date":"2017-08-01","phase":"N/A","enrollment":56,"brief_title":"Rehabilitation of Visual Function After Brain Injury","official_title":"Rehabilitation of Visual Function After Brain Injury - Effect of Neuro Vision Technology (NVT)","primary_completion_date":"2022-07-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-07-31","last_update":"2021-03-30","description":"In Denmark, about 120,000 people suffer from brain damage, of whom approx. 75,000 with brain damage after stroke. Serious and often lasting vision impairments affect 20% to 35% of people after stroke. Vision is the most important sense in humans, and even smaller permanent injuries can drastically reduce quality of life. Vision impairments after brain damage inhibits rehabilitation and enhances other invalidating effects. Reduced vision results in impaired balance, increased risk of serious falls, increased support needs, reduced quality of life, and impaired ability to perform activities of daily living. Restoration of visual field impairments occur only to a small extent during the first month after brain damage, and therefore the time window for spontaneous improvements is very limited. Hence, brain-impaired persons with visual impairment will most likely experience chronically impaired vision already 4 weeks after brain injury and the need for visual compensatory rehabilitation is substantial. Neuro Vision Technology (NVT) is an supervised training course where people with visual impairments are trained in compensatory techniques using special equipment. Through the NVT process, the individual's vision problems are carefully investigated and personal data is used to organize individual training sessions that practice the individual in coping with situations that cause problems in everyday life. The purpose of this study is to investigate whether rehabilitation with NVT can cause significant and lasting improvement in functional capacity in persons with chronic visual impairments after brain injury. Improving eyesight is expected to increase both physical and mental functioning, thus improving the quality of life. Participants included in the project will be investigated in terms of both visual and mental functions, including quality of life, cognition and depression. Such an investigation has not been performed previously and can have a significant impact on vision rehabilitation both nationally and internationally.","other_id":"H-17001534","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","intervention_model_description":"Randomized controlled trial","sampling_method":"","gender":"All","minimum_age":14,"population":"","criteria":"\n        Inclusion criteria:\r\n\r\n          -  14 years or older with brain injury.\r\n\r\n          -  Persons who experience significant vision impairment.\r\n\r\n          -  Eye sight 6/18 or better.\r\n\r\n          -  The time from symptoms onset to study inclusion is between 6 weeks and 9 months.\r\n\r\n        Exclusion criteria:\r\n\r\n          -  Cognitive dysfunction.\r\n\r\n          -  Persons with anosognosia or severe neglect.\r\n\r\n          -  Inability to move independently at least 35 meters with or without assistance,\r\n             including wheelchairs.\r\n\r\n          -  Inability to understand Danish or with communication disorders that prevent\r\n             participation in tests.\r\n\r\n          -  Terminal disorder, other progressive disorder.\r\n\r\n          -  Significant abuse of alcohol or euphoric or narcotic drugs.\r\n\r\n          -  Serious disorders such as mental illness, especially severe depression.\r\n\r\n          -  New brain injury or other significant disorders emerging after study inclusion.\r\n\r\n          -  Impaired vision not due to brain damage, where the disorder is not considered to be\r\n             permanent or where the field of vision does not cause significant disability.\r\n      ","sponsor":"University Hospital, Gentofte, Copenhagen","sponsor_type":"Other","conditions":"Stroke, Ischemic|Brain Injuries|Stroke Hemorrhagic|Traumatic Brain Injury","interventions":[{"intervention_type":"Device","name":"Device: Neuro Vision Technology","description":"Training using Neuro Vision Technology"}],"outcomes":[{"outcome_type":"primary","measure":"Ability to complete a mobility route","time_frame":"3 months","description":"Target identification and thus to compare how many targets are seen after the intervention."},{"outcome_type":"secondary","measure":"Time to complete a mobility route","time_frame":"3 months","description":"Time consumption and thus speed to complete the mobility route. Through the route there are a number of targets (stars) that study participants should try to locate. Investigators measure the time spent by study participants on the route, as well as the number of targets ignored by any participant. Measured in minutes and seconds."},{"outcome_type":"secondary","measure":"National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25)","time_frame":"3 months","description":"Questionnaire dealing with vision problems and concerns associated with a person's visual function. Measured in points summing up several scales."},{"outcome_type":"secondary","measure":"Short Form (36) Health Survey (SF-36)","time_frame":"3 months","description":"Assessment of quality of life. Measured in points summing up several scales."},{"outcome_type":"secondary","measure":"Montreal Cognitive Assessment (MoCA)","time_frame":"3 months","description":"Cognitive screening test that provides an estimate of the intellectual functional level."},{"outcome_type":"secondary","measure":"Fatigue Severity Scale-7","time_frame":"3 months","description":"Short fatigue test."},{"outcome_type":"secondary","measure":"Multidimensional Fatigue Inventory 20 (MFI-20)","time_frame":"3 months","description":"Fatigue test used to assess the occurrence of physical fatigue, mental fatigue, activity level, motivation and general fatigue."},{"outcome_type":"secondary","measure":"Test of Attentional Performance (TAP) Test 2.3: Visual Field","time_frame":"3 months","description":"Test for field defects in which the subject will respond quickly to stimuli in the field of view."},{"outcome_type":"secondary","measure":"Behavioral Inattention Test (BIT)","time_frame":"3 months","description":"Test of attention and vision."},{"outcome_type":"secondary","measure":"Rey-Osterrieth's complex figure test","time_frame":"3 months","description":"Copying advanced visual figure (without recall)."},{"outcome_type":"secondary","measure":"Modified Barthel-100 Index","time_frame":"3 months","description":"Assessment of invalidity rate and ability to perform activities of daily living."},{"outcome_type":"secondary","measure":"Hemisphere differences","time_frame":"3 months","description":"As part of the study, it will be assessed whether persons with lesion of right hemisphere, ie left-field hemianopia may be more likely to be disorientated and due to neglect will overlook more details - this is done by comparing trial participants with right vs. left hemispheric lesions."}]}
{"nct_id":"NCT03230929","start_date":"2017-08-01","phase":"N/A","enrollment":25,"brief_title":"The Effect of Electromyogram (EMG) Activity on Anesthetic Depth Monitoring","official_title":"The Effect of EMG Activity on Anesthetic Depth Monitoring : Comparison Between Phase Lag Entropy and BIS","primary_completion_date":"2017-12-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-12-31","last_update":"2018-04-06","description":"Currently, a lot of equipments based on Bispectral index (BIS) is used clinically in order to measure the depth of anesthesia. Although BIS is used for the measurement of the presence of consciousness or degree of sedation during general anesthesia, it could be influenced by factors that affect or interfere with the activity of EEG because it is a numerical value which is measured by analyzing EEG. The BIS electrode for EEG analysis should be attached to the patient's forehead and the EEG signal is 0.5 - 30 Hz, the EMG signal is 30 - 300 Hz, and the BIS analyzes the 0 - 47 Hz signal. Therefore, 30 -47 Hz EMG signal may influence the BIS value and the BIS value may differ from the actual. In patients with complete muscle relaxation, the change in BIS varies in proportion to the concentration of anesthetic, but in a state with less muscle relaxation or arousal period of anesthesia when recovery of muscle relaxation occurs, BIS value may not accurately reflects the change in the depth of anesthesia. Although there is a study on the influence of the degree of muscle relaxation on BIS value, there is no study on whether phase lag entropy (PLE) measuring anesthesia depth based on different mechanism from BIS is affected by status of muscle relaxation. After measuring BIS and PLE at the same time, I will compare both of them and investigate the reliability of the measurement of the depth of anesthesia of PLE and how electromyogram activity affects PLE.","other_id":"L-2017-165","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Screening","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  The patient who is scheduled for operation requiring general anesthesia and whose\r\n             American Society of Anesthesiologists (ASA) status is I or II.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Who has neuromuscular disease\r\n\r\n          -  Who takes medicines related neurologic system\r\n      ","sponsor":"Pusan National University Yangsan Hospital","sponsor_type":"Other","conditions":"General Anesthetic Drug Overdose","interventions":[{"intervention_type":"Device","name":"Device: BIS-PLE","description":"Anesthesiologist attaches the sensors of BIS and PLEM 100 on the forehead of the patient, and adheres the neuromuscular monitoring device on the medial side of the wrist and the ipsilateral thumb to continuously monitor the state of consciousness and muscle relaxation before, during and after surgery. Reversal of muscle relaxant could be performed by intravenous injection of sugammadex 4 mg/ kg in the case of deep neuromuscular relaxation, and 2 mg / kg in the case of shallow muscle relaxation degree under neuromuscular monitoring. After then, they monitor and record the values of BIS, PLEM 100, and neuromuscular monitoring in 1 minute increments for 5 minutes."}],"outcomes":[{"outcome_type":"primary","measure":"The difference of phase lag entropy between before and after neuromuscular recovery","time_frame":"24 hours","description":"PLEM 100 is 4-channel electroencephalogram (EEG) monitor and it records electric activity signals of the brain generated from the human body. The anesthesiologist administers sugammadex intravenously at the end of the surgery, and then monitors and records the values of BIS, PLEM 100, and neuromuscular monitoring in 1 minute increments for 5 minutes until neuromuscular recovery is completed."},{"outcome_type":"secondary","measure":"The difference between BIS and phase lag entropy during general anesthesia","time_frame":"24 hours","description":"BIS uses the frequency, amplitude, phase angle of electroencephalogram, and measures the coherence. Finally, it is closely related to the level of sedation and consciousness by the anesthetic agent. PLEM 100 is 4-channel electroencephalogram monitor and it records electric activity signals of the brain generated from the human body. The anesthesiologist continuously monitor the state of consciousness and muscle relaxation from entrance of the patient to the complete recovery of muscle relaxation."}]}
{"nct_id":"NCT03277248","start_date":"2017-08-01","phase":"Phase 3","enrollment":500,"brief_title":"A Phase 3, Randomized, Multi-center, Double-blinded, Active-controlled Study to Assess the Efficacy and Safety/Tolerability of Ublituximab (TG-1101; UTX) as Compares to Teriflunomide in Subjects With Relapsing Multiple Sclerosis (RMS) (ULTIMATE 2)","official_title":"ubLiTuximab in Multiple Sclerosis Treatment Effects (ULTIMATE II STUDY)","primary_completion_date":"2020-08-04","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-11-12","last_update":"2021-05-20","description":"This is a phase 3, randomized, multi-center, double-blinded, active-controlled study that is primarily designed to assess the Annualized Relapse Rate (ARR) and safety/tolerability of ublituximab/oral placebo (TG-1101; UTX) as compared to teriflunomide/ IV placebo in subjects with relapsing MS.","other_id":"TG1101-RMS302","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","intervention_model_description":"Randomized, multi-center, double-blinded, active-controlled study","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18 - 55 age\r\n\r\n          -  Diagnosis of RMS (McDonald Criteria 2010)\r\n\r\n          -  Active disease\r\n\r\n          -  Expanded disability status scale (EDSS) 0 - 5.5 (inclusive) at screening\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Treatment with prior Anti-CD20 or other B cell directed treatment\r\n\r\n          -  Treatment with the following therapies at any time prior to randomization:\r\n             Alemtuzumab, Natalizumab, teriflunomide, Leflunomide and Stem cell transplantation\r\n\r\n          -  Diagnosed with Primary Progressive MS (PPMS)\r\n\r\n          -  Pregnant or nursing\r\n      ","sponsor":"TG Therapeutics, Inc.","sponsor_type":"Industry","conditions":"Relapsing Multiple Sclerosis (RMS)","interventions":[{"intervention_type":"Biological","name":"Biological: Ublituximab","description":"Subjects will be randomized in a [1:1] ratio to receive either ublituximab/ oral placebo on specfied days or teriflunomide/ IV placebo (14mg, once daily starting on Week1 Day1)"},{"intervention_type":"Drug","name":"Drug: Teriflunomide","description":"Subjects will be randomized in a [1:1] ratio to receive either ublituximab/ oral placebo on specfied days or teriflunomide/ IV placebo (14mg, once daily starting on Week1 Day1)"}],"outcomes":[{"outcome_type":"primary","measure":"Annualized Relapse Rate (ARR)","time_frame":"96 weeks on therapy","description":"Measure the number of relapses per year per patient"},{"outcome_type":"secondary","measure":"Number of participants with treatment-related adverse events as assessed by CTCAE v4.0","time_frame":"96 weeks on therapy","description":"To determine the incidence of adverse events and any abnormal laboratory values"}]}
{"nct_id":"NCT04478383","start_date":"2017-08-01","enrollment":11,"brief_title":"Repair of Achilles Sleeve Avulsion: a New Transosseous Suture Technique","official_title":"Repair of Achilles Sleeve Avulsion: a New Transosseous Suture Technique","primary_completion_date":"2018-02-01","study_type":"Observational","rec_status":"Completed","completion_date":"2018-05-01","last_update":"2020-07-20","description":"This retrospective study identified 12 patients with Achilles sleeve avulsion from November 2013 to March 2016, aiming to explore a new transosseous suture technique for the repair of Achilles sleeve avulsion and observe the short-term curative effect.","other_id":"M2018008","observational_model":"Case-Only","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","population":"One patient was lost to follow-up because she could not be contacted, having moved out of\r\n        the country. The remaining 11 patients (10 men and one woman, average age: 46 years) were\r\n        reviewed with an average follow-up time of 40 months (30-57 months).","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  clinical presentations and physical examination, routine ankle X ray and MRI\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  calcaneal tuberosity avulsion fractures\r\n\r\n          -  Achilles tendon rerupture\r\n\r\n          -  previous surgical procedure on the affected Achilles tendon\r\n      ","sponsor":"Peking University Third Hospital","sponsor_type":"Other","conditions":"Achilles Tendon Rupture|Fracture, Avulsion","interventions":[{"intervention_type":"Procedure","name":"Procedure: a new transosseous suture technique","description":"a new technique using the spur base on the insertional site to drill the suture tunnel to repair Achilles sleeve avulsion."}],"outcomes":[{"outcome_type":"primary","measure":"change of Victorian Institute of Sports Assessment-Achilles score","time_frame":"from pre-surgery to two years after surgery","description":"The VISA-A questionnaire displayed construct validity when used in two populations of patients with Achilles tendinopathy and control subjects. The questionnaire avoids the redundant components of non-specific scoring systems such as that developed for hind foot problems by the American Orthopaedic Society, and those devised for Achilles tendon rupture. Results range from 0 to 100, where 100 represents the perfect score."},{"outcome_type":"primary","measure":"change of visual analog scale","time_frame":"from pre-surgery to two years after surgery","description":"The Visual Analogue Scale (VAS) is designed to present to the respondent a rating scale with minimum constraints. Respondents mark the location on the 10-centimeter line corresponding to the amount of pain they experienced. This gives them the greatest freedom to choose their pain's exact intensity. It also gives the maximum opportunity for each respondent to express a personal response style. The minimum and maximum values of VAS are 10 and 0, respectively. And higher scores mean a worse outcome."},{"outcome_type":"primary","measure":"change of American Orthopaedic Foot & Ankle Society score","time_frame":"from pre-surgery to two years after surgery","description":"The American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score combines subjective scores of pain and function provided by the patient with objective scores based on the surgeon's physical examination of the patient (to assess sagittal motion, hindfoot motion, ankle-hindfoot stability and alignment of the ankle-hindfoot). The scale includes nine items that can be divided into three subscales (pain, function and alignment). The minimum and maximum values of AOFAS are 100 and 0, respectively. And higher scores mean a better outcome."},{"outcome_type":"primary","measure":"change of Tegner score","time_frame":"from pre-surgery to two years after surgery","description":"The Tegner activity scale was first described in 1985 and initially designed for physician administration after ACL and meniscal injuries. To date, the Tegner activity score has been a frequently used patient-administered activity rating system for patients with various knee disorders. The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer."}]}
{"nct_id":"NCT03220178","start_date":"2017-07-24","phase":"Phase 4","enrollment":960,"brief_title":"Impact of eHealth-support on Quality of Life in Metastatic Breast Cancer Patients Treated With Palbociclib and Endocrine Therapy","official_title":"PRECYCLE: Multicenter, Randomized Phase IV Intergroup Trial to Evaluate the Impact of eHealth-based Patient Reported Outcome (PRO) Assessment on Quality of Life in Patients With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Treated With Palbociclib and an Aromatase Inhibitor- or Palbociclib and Fulvestrant","primary_completion_date":"2027-06-30","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2027-06-30","last_update":"2021-07-14","description":"In this study the investigators assess the impact of the eHealth-supported therapy management system CANKADO on Quality of Life in patients with HR+, HER2-locally advanced or metastatic breast cancer treated with the cyclin dependent kinase 4/6 (CDK4/6) Inhibitor Palbociclib in combination with an aromatase inhibitor or fulvestrant. Furthermore this approach will be combined with biomarker screening to identify predictive markers for and to learn more about adherence, symptoms, response, and resistance.","other_id":"PH001-PreCycle","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Post- or pre/peri-menopausal female patients, age 18 years\r\n\r\n          2. Patients with metastatic or locally advanced (non-operable) breast cancer disease\r\n\r\n          3. Patients who are appropriate candidates for aromatase inhibitor + palbociclib\r\n             combination therapy OR Patients having already received endocrine therapy who are\r\n             appropriate candidates for fulvestrant+ palbociclib combination therapy\r\n\r\n          4. Patient has not received treatment for locally advanced or metastatic disease OR\r\n             Patient has received one prior line of chemotherapy and/or a maximum of two endocrine\r\n             therapy lines for locally advanced or metastatic disease\r\n\r\n          5. Peri-/pre-menopausal patients should additionally receive a GnRH-agonist..\r\n\r\n          6. The tumor must be hormone-receptor positive\r\n\r\n          7. The tumor must be HER2-negative defined as either HER2 immunohistochemistry Score 0 or\r\n             1+ or as HER2-negative by in situ hybridization..\r\n\r\n          8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2\r\n\r\n          9. Adequate organ and marrow function before palbociclib treatment starts on C1D.\r\n\r\n         10. In case of patients of child bearing potential: negative pregnancy test (urine or\r\n             serum) at baseline. Patients must agree to use highly effective non-hormonal\r\n             contraception\r\n\r\n         11. Resolution of all acute toxic effects of prior therapy, including radiotherapy grade\r\n             <1 (except toxicities not considered a safety risk for the patient) and recovery from\r\n             surgical procedures\r\n\r\n         12. Signed Written Informed Consent\r\n\r\n         13. Willingness and capability to use CANKADO\r\n\r\n         14. Availability of hardware: Computer and/or tablet and/or smartphone with internet\r\n             access\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Known hypersensitivity to aromatase inhibitor, fulvestrant, palbociclib or any of its\r\n             excipients\r\n\r\n          2. Contraindication for aromatase inhibitor, fulvestrant or palbociclib; or GnRH-agonists\r\n             (if pre-menopausal)\r\n\r\n          3. Prior treatment with any inhibitor of cyclin dependent kinase (CDK).\r\n\r\n          4. Patients with locally advanced or metastatic, symptomatic, visceral spread, who are at\r\n             risk of life threatening complications in the short term\r\n\r\n          5. Known active uncontrolled or symptomatic central nervous system metastases\r\n\r\n          6. Current use of food or drugs known to be potent inhibitors or inducers of Cytochrome\r\n             P450 3A4 (CYP3A4)\r\n\r\n          7. High cardiovascular risk, including, but not limited to recent myocardial infarction,\r\n             severe/unstable angina, or severe cardiac dysrhythmias in the past 6 months of\r\n             enrollment\r\n\r\n          8. Diagnosis of any second malignancy within the last 5 years prior to enrollment, except\r\n             for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ\r\n             of the cervix\r\n\r\n          9. Participation in other clinical trials involving investigational drug(s) (Phases 1-4)\r\n             within 2 weeks before the current study begins and/or during study participation\r\n\r\n         10. Lactating women\r\n\r\n         11. Life expectancy < 3 months\r\n\r\n         12. Known infection with HIV, hepatitis B virus, or hepatitis C virus\r\n\r\n         13. Concurrent severe, uncontrolled systemic disease, social or psychiatric condition that\r\n             might interfere with the planned treatment and with the patient's adherence to the\r\n             protocol\r\n\r\n         14. Legal incapacity or limited legal capacity.\r\n      ","sponsor":"Palleos Healthcare GmbH","sponsor_type":"Industry","conditions":"Breast Neoplasm","interventions":[{"intervention_type":"Drug","name":"Drug: Palbociclib","description":"Palbociclib 125mg/day orally dosed for 3 weeks followed by 1 week off; repeated for each treatment cycle"},{"intervention_type":"Drug","name":"Drug: Fulvestrant","description":"500mg per use-after first application, again at wk2, then once per month"},{"intervention_type":"Drug","name":"Drug: Anastrozole","description":"1mg per day"},{"intervention_type":"Drug","name":"Drug: Letrozole","description":"2,5mg/day"},{"intervention_type":"Drug","name":"Drug: Exemestane","description":"25mg/day"}],"outcomes":[{"outcome_type":"primary","measure":"DQoL","time_frame":"From start of study treatment up to 4 years","description":"The event \"deterioration of quality of life\" (DQoL) will be measured every 28 days after enrolment using the FACT-B scale."},{"outcome_type":"secondary","measure":"Progression-free survival","time_frame":"From start of study treatment up to 4 years","description":"Progression-free survival (PFS) is considered to be the main clinical outcome and is defined as the time between treatment allocation and either first documentation of objective progression of disease (PD), as assessed by Investigator or death due to any cause in absence of PD."},{"outcome_type":"secondary","measure":"Overall survival","time_frame":"From start of study treatment up to 4 years","description":"Overall survival (OS) is defined as the time between treatment allocation and death due to any cause."},{"outcome_type":"secondary","measure":"Drug intake","time_frame":"From start of study treatment up to 4 years","description":"Daily electronic documentation of dosage and time of drug intake."},{"outcome_type":"secondary","measure":"Global health status","time_frame":"From start of study treatment up to 4 years","description":"Daily electronic rating of overall health-related quality of life on a visual analogue scale (EQ-VAS) between 100 (best health imaginable) and 0 (worst health imaginable)."}]}
{"nct_id":"NCT02949817","start_date":"2017-07-24","phase":"N/A","enrollment":40,"brief_title":"The Effect of Digital Rehabilitation System With Wearable Multi-IMU (Inertial Measurement Unit) Sensors on Upper Limb Functions in Children With Brain Injury","official_title":"The Effect of Digital Rehabilitation System With Wearable Multi-IMU (Inertial Measurement Unit) Sensors on Upper Limb Functions in Children With Brain Injury: Single Blind Randomized Controlled Study","primary_completion_date":"2018-02-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-02-01","last_update":"2018-07-19","description":"This study was designed to establish the clinical evidence for effect of video-game based rehabilitation therapy system using IMU sensors as a game interface, newly-developed in Korea, on upper limb function of children with cerebral palsy. First, the investigators would compare the effect of video-game based rehabilitation therapy to conventional occupational therapy.","other_id":"1-2015-0097","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":4,"maximum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  MACS (Manual ability classification system) level I, II, III, IV\r\n\r\n          -  Patients without cognitive impairment who are able to comply with protocol-required\r\n             procedure\r\n\r\n          -  male or female, 4 to 18 years\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with cognitive impairment who are unable to comply with protocol-required\r\n             procedure\r\n\r\n          -  Patients with significant visual impairment\r\n\r\n          -  Patients with presence or history of musculoskeletal anomaly who are unable to apply\r\n             device\r\n      ","sponsor":"Yonsei University","sponsor_type":"Other","conditions":"Cerebral Palsy|Children With Brain Injury","interventions":[{"intervention_type":"Other","name":"Other: Conventional OT group","description":"2. Conventional OT group will recieve the conventional occupational therapy and one more conventional occupational therapy additionally. The additional occupational therapy training will be performed 30 minutes daily 5 times per week, for 4 weeks."},{"intervention_type":"Device","name":"Device: digital rehabilitation system with wearable multi-IMU(inertial measurement unit) sensors (Rapael kids)","description":"1.The Rapael kids, a video-game based rehabilitation therapy system using IMU sensors as a game interface, newly-developed in Korea will be used on upper limb function of children with pediatric brain injury patients. 20 of All 40 children will receive the conventional occupational therapy and additional video-game based rehabilitation therapy, 30 minutes daily 5 times per week, for 4 weeks."}],"outcomes":[{"outcome_type":"primary","measure":"Total score of Melbourne Assessment of Unilateral Upper Limb Function","time_frame":"8 weeks","description":"MUUL is the test of unilateral upper limb function is a validated and reliable tool for evaluating quality of upper limb movement in children with neurological conditions. It comprises 14 test items of reaching to, grasping, releasing and manipulating simple objects. Scoring is completed for the 30 item scores using a three, four or five point scale and the individually defined scoring criteria. The test will be done by occupational therapist. The total score of MUUL will be used for analysis."},{"outcome_type":"secondary","measure":"Total score of upper limb physician's rating scale (ULPRS)","time_frame":"8 week","description":"ULPRS assess changes in the movement pattern, focusing on all 3 levels of the arm (palm, forearm, and elbow) to determine whether there is an isolated functional impairment, such as thumb in palm, restricted forearm supination, or a total flexion pattern with thumb in palm, wrist in flexion, forearm supinated, and elbow flexed. The score sheet includes 9 items, and 3-, 4-, and 5-point scales are used to score each component of movement tested. The total score of ULPRS will be used for analysis."},{"outcome_type":"secondary","measure":"Scaled scores of Pediatric Evaluation of Disability Inventory (PEDI-selfcare)","time_frame":"8 week","description":"PEDI is a descriptive measure of a child's current functional performance. It measures both capability and performance of functional activities in three content domains: Self-care, Mobility, Social function. PEDI-selfcare section will be administered by occupational therapist. The Scaled scores of PEDI-selfcare will be used for analysis."},{"outcome_type":"secondary","measure":"Kinematic data of computerized 3D motion analysis","time_frame":"8 week","description":"3D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup. Kinematic data of forearm pronation or supination, wrist flexion or extension, ulnar deviation or radial deviation will be used for analysis."}]}
{"nct_id":"NCT03219788","start_date":"2017-07-20","phase":"Phase 2","enrollment":120,"brief_title":"Remifentanil and Desflurane Inhalational Anesthesia in Bariatric Surgeries","official_title":"The Recovery Profile of Different Doses of Remifentanil After Desflurane Inhalational Anesthesia for Bariatric Surgeries: Two Centers Controlled Prospective Study","primary_completion_date":"2017-11-01","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2017-11-01","last_update":"2017-07-18","description":"The number of obese and overweighted persons doubled since 1980. They are 600 million in 2014 all over the world. Obesity results in anatomical, physiological and pharmacological changes which represent a challenge for every anesthetist. Difficult airway increases by 30% with obesity and so awake extubation are the preferred technique. Coughing can be alleviated by opioid receptors which play a role in the cough reflex. Remifentanil may be useful as an ultra-short acting opioid and its effect swiftly and predictably disappears after cessation. An emergence cough is attenuated by remifentanil administered via continuous infusion (TCI), and the expected effective effect-site concentrations investigated have ranged from 1.5 to 2.5 ng.ml/L.","other_id":"IRB00008715892","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age 18 years\r\n\r\n          2. Subject has signed informed consent for bariatric laparoscopic surgery.\r\n\r\n          3. Subject must be ASA I or ASA II according to the American Society of Anesthetists\r\n             classification.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Age < 18 years.\r\n\r\n          2. Smoking patient.\r\n\r\n          3. Hypertension.\r\n\r\n          4. Bronchial asthma.\r\n\r\n          5. Obstructive sleep apnea syndrome.\r\n      ","sponsor":"Assiut University","sponsor_type":"Other","conditions":"Anesthesia Emergence","interventions":[{"intervention_type":"Drug","name":"Drug: Normal Saline","description":"All the patient will be anesthetized using a standard anesthetic technique. One ml normal saline will be given"},{"intervention_type":"Drug","name":"Drug: Remifentanil 0.1 ug/kg","description":"All the patient will be anesthetized using a standard anesthetic technique. One ml normal saline contains 0.1 ug/kg Remifentanil will be given"},{"intervention_type":"Drug","name":"Drug: Remifentanil 0.2 ug/kg","description":"All the patient will be anesthetized using a standard anesthetic technique. One ml normal saline contains 0.2 ug/kg Remifentanil will be given"}],"outcomes":[{"outcome_type":"primary","measure":"Changes in hemodynamic","time_frame":"within the first 24 hours","description":"Mean blood pressure and heart rate will be recorded before surgery and combined with all the other study items at the end of surgery, at the extubation time, after 5 minutes in PACU, after 10 minutes in Postanesthesia Care Unit (PACU) and he last registered reading in PACU."},{"outcome_type":"primary","measure":"antitussive effect","time_frame":"within the first 24 hours","description":"cough assessment at recovery time 0 no cough\r\nsingle cough\r\ncough episode less than five seconds or multiple coughs\r\nsustained attack of cough lasts more than five seconds"},{"outcome_type":"secondary","measure":"Respiratory depression","time_frame":"within the first 24 hours","description":"In the postoperative period"},{"outcome_type":"secondary","measure":"Postoperative pain","time_frame":"within the first 24 hours","description":"The duration from extubation till the first painkiller and pain severity using VAS at the extubation time will recorded"}]}
{"nct_id":"NCT02541955","start_date":"2017-07-20","phase":"Phase 4","enrollment":40,"brief_title":"Use of Acthar in Rheumatoid Arthritis (RA) Related Flares","official_title":"Use of Acthar in Rheumatoid Arthritis Related Flares","primary_completion_date":"2021-06-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-06-30","last_update":"2020-11-04","description":"This is a Rheumatoid Arthritis (RA) study. The purpose of this research study is to determine in RA flare, whether musculoskeletal ultrasound (MSUS) inflammatory scores and/or disease activity scores improve with Acthar treatment.","other_id":"Acthar in Rheumatoid Arthritis","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patient must meet 1987 ACR criteria\r\n\r\n          2. Age > 18 years of age\r\n\r\n          3. Baseline DAS28/Erythrocyte Sedimentation Rate (ESR) >=3.2\r\n\r\n          4. Stable concomitant Disease Modifying Anti-Rheumatic Drugs (DMARDs)\r\n\r\n          5. Stable prednisone <10mg or equivalent\r\n\r\n          6. Power Doppler score of >=10\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Prior treatment with Acthar in the past 2mos\r\n\r\n          2. Meet one of the above RA flare requirements\r\n\r\n          3. Subjects who have received live or live attenuated vaccines within 6 weeks prior to\r\n             the first dose of study drug (or the zoster vaccine)\r\n      ","sponsor":"Dr. Veena Ranganath","sponsor_type":"Other","conditions":"Rheumatoid Arthritis (RA)","interventions":[{"intervention_type":"Drug","name":"Drug: Acthar","description":"Injections will be self administered"}],"outcomes":[{"outcome_type":"primary","measure":"Ultrasound Power Doppler Score","time_frame":"Baseline to 2 Weeks","description":"Using Ultrasound a measure of Power Doppler will be calculated. The change in the scores will be analyzed between the two groups."},{"outcome_type":"primary","measure":"DAS28","time_frame":"Baseline to 2 Weeks","description":"DAS28 will be calculated. The change in the scores will be analyzed between the two groups."},{"outcome_type":"secondary","measure":"Ultrasound Grey Scale Synovial Hypertrophy score","time_frame":"Baseline to 2 Weeks","description":"Using Ultrasound a measure of Grey Scale Synovial Hypertrophy will be calculated. The change in the scores will be analyzed between the two groups."},{"outcome_type":"secondary","measure":"HAQ-DI","time_frame":"Baseline to 4 Weeks","description":"Self-administered HAQ-DI summary score will be calculated. The change in the scores will be analyzed between the two groups"}]}
{"nct_id":"NCT03092323","start_date":"2017-07-19","phase":"Phase 2","enrollment":102,"brief_title":"A Randomized Trial of Pembrolizumab & Radiotherapy Versus Radiotherapy in High-Risk Soft Tissue Sarcoma of the Extremity","official_title":"SU2C-SARC032: A Phase II Randomized Controlled Trial of Neoadjuvant Pembrolizumab With Radiotherapy and Adjuvant Pembrolizumab in Patients With High-Risk, Localized Soft Tissue Sarcoma of the Extremity","primary_completion_date":"2024-07-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2025-07-30","last_update":"2021-07-06","description":"This is an open-label, multi-institutional phase II randomized study comparing neoadjuvant radiotherapy followed by surgical resection to neoadjuvant pembrolizumab with concurrent radiotherapy, followed by surgical resection and adjuvant pembrolizumab. The total duration of pembrolizumab will be one year in the experimental arm.","other_id":"SU2C-SARC032","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":12,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age  12 years\r\n\r\n          -  Histologically confirmed diagnosis of grade 2 or 3 out of 3 UPS or\r\n             dedifferentiated/pleomorphic LPS of the extremity (including limb girdle, i.e.\r\n             shoulder or hip) that measures greater than 5 cm in any direction as assessed by\r\n             imaging\r\n\r\n          -  Patients with non-melanomatous skin cancer, in situ carcinoma, or low-risk prostate\r\n             cancer can be enrolled.\r\n\r\n          -  ECOG Performance Status of 0 or 1\r\n\r\n          -  Resectable primary tumor with no evidence of metastatic disease by imaging.\r\n\r\n          -  Adequate organ function within 10 days of Day 1\r\n\r\n          -  Written, voluntary informed consent\r\n\r\n          -  Fertile men and women of childbearing potential must agree to use an effective method\r\n             of birth control from Day 1 of study and for 120 days after last pembrolizumab\r\n             administration in both sexes. Women of childbearing potential include pre-menopausal\r\n             women and women within the first 2 years of the onset of menopause. Women of\r\n             childbearing potential must have a negative pregnancy test  72 hours prior to Day 1\r\n             of study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior chemotherapy, targeted small molecule therapy, or radiation therapy for current\r\n             diagnosis of sarcoma\r\n\r\n          -  Prior radiation therapy in excess of 20 Gy to the site of the current diagnosis of\r\n             sarcoma. No overlap with prior radiation fields in excess of 20 Gy is allowed.\r\n\r\n          -  Concurrent, clinically significant, active malignancies within two years of study\r\n             enrollment.\r\n\r\n          -  Patients with locally recurrent sarcoma after surgery alone are eligible for\r\n             enrollment if other inclusion criteria are met.\r\n\r\n          -  Patients with severe and/or uncontrolled concurrent medical disease that in the\r\n             opinion of the investigator could cause unacceptable safety risks or compromise\r\n             compliance with the protocol\r\n\r\n          -  Major surgery within four weeks prior to Day 1 of study or who have not recovered\r\n             adequately from prior surgery.\r\n\r\n          -  Currently receiving a study therapy or if they had an investigational agent within 4\r\n             weeks at the time of enrollment.\r\n\r\n          -  Women who are pregnant or nursing/breastfeeding, or expecting to conceive or men who\r\n             are expecting to father children within the projected duration of the trial, starting\r\n             with the pre-screening or screening visit through 120 days after the last dose of\r\n             pembrolizumab.\r\n\r\n          -  Inability to comply with protocol required procedures\r\n\r\n          -  Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other\r\n             form of immunosuppressive therapy by oral or IV routes within 7 days prior to the\r\n             first dose of trial treatment\r\n\r\n          -  Known history of active TB (Bacillus Tuberculosis)\r\n\r\n          -  Hypersensitivity to pembrolizumab or any of its excipients\r\n\r\n          -  Metastatic disease or regional lymph node involvement. Chest CT will be mandatory\r\n             prior to enrollment to evaluate for the presence of metastatic disease. Pulmonary\r\n             nodule(s) < 5 mm without a histological diagnosis may not be the basis for study\r\n             exclusion given the lack of specificity of chest CT. If pulmonary nodule(s) measuring\r\n             6 - 10 mm are noted on chest CT but appear stable relative to prior chest imaging of\r\n             at least 6 months duration or if 18FDG-PET scan indicates that the nodule(s) are\r\n             unlikely to be metastatic disease, then this is permitted. Pulmonary nodules >10 mm\r\n             should be considered metastatic unless proven otherwise by biopsy/resection or stable\r\n             appearance for at least 6 months on imaging.\r\n\r\n          -  Unresectable disease or medically inoperable\r\n\r\n          -  Planned to receive neoadjuvant or adjuvant chemotherapy for current diagnosis of\r\n             localized soft tissue sarcoma\r\n\r\n          -  Active autoimmune disease that has required systemic treatment in the past two years\r\n             (i.e. with use of disease modifying agents, systemic corticosteroids or\r\n             immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or\r\n             physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency,\r\n             etc.) is not considered a form of systemic treatment.\r\n\r\n          -  Has a history of (non-infectious) pneumonitis that required systemic steroids or\r\n             current pneumonitis.\r\n\r\n          -  Active infection requiring systemic therapy\r\n\r\n          -  Known psychiatric or substance abuse disorders that would interfere with cooperation\r\n             with the requirements of the trial\r\n\r\n          -  Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent\r\n\r\n          -  Known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)\r\n\r\n          -  Known active Hepatitis B (e.g., HBsAg reactive, confirmed by detectable viral load) or\r\n             Hepatitis C (e.g., HCV RNA [qualitative] detected)\r\n\r\n          -  Received a live vaccine within 30 days of planned start of study therapy. Note:\r\n             Seasonal influenza vaccines for injection are generally inactivated flu vaccines and\r\n             are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live\r\n             attenuated vaccines, and are not allowed.\r\n\r\n          -  Diagnosis of scleroderma.\r\n\r\n          -  Diagnosis of inflammatory bowel disease (Crohn's disease or Ulcerative Colitis).\r\n      ","sponsor":"Sarcoma Alliance for Research through Collaboration","sponsor_type":"Other","conditions":"Soft Tissue Sarcoma of the Extremity","interventions":[{"intervention_type":"Drug","name":"Drug: Pembrolizumab","description":"Pembrolizumab will be administered at 200 mg intravenously every 3 weeks for patients on the treatment arm."}],"outcomes":[{"outcome_type":"primary","measure":"Disease free survival","time_frame":"2 Years","description":"Disease recurrence is defined as clinically diagnosed or biopsy-confirmed recurrent sarcoma at a site distant to the primary tumor, including nodal metastasis, loco-regional recurrence, and death without documented recurrence."},{"outcome_type":"secondary","measure":"Loco-regional disease-free survival","time_frame":"5 years","description":"The length of time after treatment ends without any locoregional recurrence of sarcoma."},{"outcome_type":"secondary","measure":"Distant disease free survival","time_frame":"5 years","description":"The length of time after treatment ends that the patient survives without any signs or symptoms of sarcoma"},{"outcome_type":"secondary","measure":"Overall survival","time_frame":"5 years","description":"The length of time from the start of treatment that patients diagnosed with sarcoma are still alive."},{"outcome_type":"secondary","measure":"Number of participants with treatment-related adverse events as assessed by CTCAE v4.0","time_frame":"5 years","description":"Test the safety of neoadjuvant pembrolizumab administered with conventionally fractionated radiotherapy targeting soft tissue sarcoma of the extremity."}]}
{"nct_id":"NCT03192202","start_date":"2017-07-17","phase":"Phase 1/Phase 2","enrollment":18,"brief_title":"AFM13 in Relapsed/Refractory Cutaneous Lymphomas","official_title":"Clinical and Biological Evaluation of the Novel CD30/CD16A Tetravalent Bispecific Antibody (AFM13) in Relapsed or Refractory CD30-Positive Lymphoma With Cutaneous Presentation: A Biomarker Phase Ib/IIa Study","primary_completion_date":"2020-04-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-04-01","last_update":"2020-07-16","description":"The investigators plan to investigate AFM13 and evaluate its ability to facilitate and redirect the Natural Killer (NK) cells in eliminating CD30-positive lymphoma targets in the skin and, by inference, other organs involved by the lymphoma.","other_id":"AAAP4461","allocation":"Non-Randomized","intervention_model":"Sequential Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age 18 years\r\n\r\n          -  Histologically confirmed CD30-positive lymphoma with cutaneous involvement\r\n\r\n          -  Failure or intolerance to at least one prior therapy for the current disease\r\n\r\n          -  Presence of one or more cutaneous lesions (measuring at least 1 cm x 1 cm in size; if\r\n             only one lesion is present it should be up to the investigator discretion to determine\r\n             eligibility)\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status 2\r\n\r\n          -  Adequate organ and marrow function\r\n\r\n          -  Platelets 50,000/L\r\n\r\n          -  Absolute neutrophil count  1,000/L\r\n\r\n          -  Bilirubin < 1.5 x institutional upper limit of normal (ULN) or < 3 x ULN in patients\r\n             with Gilbert's disease or liver involvement\r\n\r\n          -  Serum albumin  2.0 g/dL\r\n\r\n          -  Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) 2.5  institutional\r\n             ULN or, in the case of liver involvement by the primary disease AST/ALT  5 x ULN\r\n\r\n          -  Creatinine1.5 x institutional ULN or estimated creatinine clearance of 45 mL/min by\r\n             the Cockcroft-Gault equation or measured creatinine clearance >45 mL/min\r\n\r\n          -  Females of child bearing potential must have a negative serum pregnancy test with 7\r\n             days prior to first dose of treatment. Female patients of childbearing potential and\r\n             all male partners must agree to use double barrier methods of contraception throughout\r\n             the study period and for at least 30 days following investigational product\r\n             discontinuation.\r\n\r\n          -  Ability to understand and the willingness to sign a written informed consent document.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any cancer-related therapy for the current disease within 2 weeks of screening (all\r\n             supportive care measures are allowed)\r\n\r\n          -  Major surgery within 2 weeks prior to first dose of study drug\r\n\r\n          -  Evidence of active central nervous system (CNS) involvement\r\n\r\n          -  Requirement for systemic immunosuppressive therapy (e.g. Graft-versus-Host Disease\r\n             (GVHD) therapy within 12 weeks before the first dose of study drug)\r\n\r\n          -  Uncontrolled concurrent serious illness.\r\n\r\n          -  Concurrent malignancy or history of a previous malignancy within 3 years prior to\r\n             first dose of the current study, unless curatively resected basal, squamous cell\r\n             carcinoma of the skin, or cervical carcinoma in situ.\r\n\r\n          -  Active infections including hepatitis B carrier status, hepatitis C virus (HCV)\r\n             infection (patients must have a negative Hepatitis B and Hepatitis C viral load at\r\n             screening)\r\n\r\n          -  Known HIV-positive status\r\n\r\n          -  Any significant medical conditions, laboratory abnormality, or psychiatric illness\r\n             that would exclude the subject from participation or interfere with study treatment,\r\n             monitoring and compliance such as:\r\n\r\n          -  unstable angina pectoris, symptomatic congestive heart failure (New York Heart\r\n             Association (NYHA) III or IV), myocardial infarction  6 months prior to first study\r\n             drug, clinically significant and uncontrolled cardiac arrhythmia (e.g. atrial\r\n             fibrillation/flutter ventricular cardiovascular physiology is allowed),\r\n             cerebrovascular accidents  6 months before study drug start\r\n\r\n          -  severely impaired lung function\r\n\r\n          -  Serious, systemic infection requiring treatment 7 days before the first dose of study\r\n             drug\r\n\r\n          -  Any severe, uncontrolled disease or condition which in the investigator's opinion, may\r\n             put the subject at significant risk, may confound the study results, or impact the\r\n             subject's participation in the study.\r\n      ","sponsor":"Ahmed Sawas","sponsor_type":"Other","conditions":"Lymphoma, T-Cell, Cutaneous","interventions":[{"intervention_type":"Drug","name":"Drug: AFM13","description":"AFM13 is a recombinant antibody construct against human CD30 and CD16A. It will be given to patients intravenously at the dose and schedule applicable to the cohort the patient was enrolled in specified in the various arms listed."}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of Intratumoral NK-cells and T-cells infiltration into tumors","time_frame":"Up to 2 years","description":"Quantified by multiplex Immuno-histochemistry (IHC) using tissue samples"},{"outcome_type":"primary","measure":"Number of immune cells (NK cells, T cells, and others) in tumor and peripheral blood","time_frame":"Up to 2 years","description":"Measured by multi-color flow cytometry and immunophenotyping technique"},{"outcome_type":"primary","measure":"Level of plasma cytokine production plus release in tumor and peripheral blood as a function of treatment","time_frame":"Up to 2 years","description":"Elisa test will be used to measure cytokine levels"},{"outcome_type":"secondary","measure":"Number of participants with treatment-related adverse events as assessed by CTCAE v4.0","time_frame":"Up to 2 years","description":"Incidence of Treatment-Emergent Adverse Events [Safety and Toxicity] broken down by adverse event and CTCAE v4.0 grade of each event."},{"outcome_type":"secondary","measure":"Overall Response Rate (ORR)","time_frame":"Up to 2 years","description":"The sum of patients with partial responses and complete responses."},{"outcome_type":"secondary","measure":"Duration of Response (DOR) after treatment with AFM 13","time_frame":"Up to 2 years","description":"The time of initial response until documented tumor progression."},{"outcome_type":"secondary","measure":"Progression Free Survival (PFS) after treatment with AFM 13","time_frame":"Up to 2 years","description":"The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse."}]}
{"nct_id":"NCT03442998","start_date":"2017-07-14","phase":"N/A","enrollment":24,"brief_title":"Walking Green: Developing an Evidence-base for Nature Prescriptions","official_title":"Walking Green: Developing an Evidence-base for Nature Prescriptions","primary_completion_date":"2019-04-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-04-01","last_update":"2019-11-01","description":"The investigators hypothesize that walking on a nature trail will lead to greater reductions in stress and greater improvements in the capacity to direct attention as compared to walking on a suburban sidewalk. The effects of walking in these different locations will be measured using physiological and psychological outcomes. The study design is a randomized with-in person cross-over trial. Subjects will take six 50-minute walks, one walk per week for six weeks. Three walks will occur in the urban setting and three in the nature setting. The order of the conditions will be randomly assigned to each subject, so that half of the subjects will complete the urban walks first and half the subjects will complete the nature walks first. There will be a two-week washout period between the two sets of walks. Day of the week will be fixed within person, and walks will occur during the mild weather months. In the case of inclement weather, the weekly walk will be skipped and an additional week will be added to the schedule. Limiting the frequency to one walk per week maximizes feasibility of the protocol and minimizes training effects, with any training effects over time being handled primarily by randomization (condition order is balanced), but also in the statistical analysis.","other_id":"1703S09101","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":35,"maximum_age":59,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age 35 to 59\r\n\r\n          -  No contraindications to physical activity\r\n\r\n          -  No major chronic diseases or specific medications that would contraindicate exercise\r\n             or potentially blunt heart rate variation during exercise\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Cardiovascular disease medication\r\n\r\n          -  Arthritis\r\n\r\n          -  Steroids\r\n\r\n          -  Certain blood pressure medications\r\n\r\n          -  Diabetes\r\n\r\n          -  Cancer\r\n\r\n          -  Self-reported depression or anxiety / taking medication for depression or anxiety,\r\n\r\n          -  Outside age range\r\n\r\n          -  Inability to follow schedule including travel to arboretum\r\n\r\n          -  Exceeding physical activity recommendations (250 minutes per week)\r\n\r\n          -  Contraindications to walking\r\n      ","sponsor":"University of Minnesota","sponsor_type":"Other","conditions":"Stress|Attention","interventions":[{"intervention_type":"Other","name":"Other: Suburban walk","description":"Each subject is tested under the 'suburban' condition. We will compare the stress response and working memory response to walking in the two experimental conditions ((1)response to walking on a nature path and (2) response to walking on an urban sidewalk)."},{"intervention_type":"Other","name":"Other: Nature walk","description":"Each subject is tested under the 'nature' condition. We will compare the stress response and working memory response to walking in the two experimental conditions ((1)response to walking on a nature path and (2) response to walking on an urban sidewalk)."}],"outcomes":[{"outcome_type":"primary","measure":"Change in PANAS","time_frame":"Measurements will be made at baseline, immediately before and after each walk of each condition (nature vs suburban).","description":"PANAS: Stress is associated with decreased positive and increased negative affect (mood). We will measure affect using the Positive and Negative Affect Scale (PANAS).\r\nScores are determined by summing the participants' answers to all 20 items from 1 (\"very slightly or not at all\") to 5 (\"extremely\") pre- and post-walk in each intervention location (nature vs suburban)."},{"outcome_type":"primary","measure":"Change in Heart Rate Variability","time_frame":"Measurements will be made at baseline one-week before the first walk, immediately before and after each walk, and within three days following the third walk of each condition (nature vs suburban).","description":"High frequency heart rate variation using ambulatory heart rate monitors (milliseconds)."},{"outcome_type":"primary","measure":"Change in Blood Pressure","time_frame":"Measurements will be made at baseline, immediately before and after each walk of each condition (nature vs suburban).","description":"Blood pressure (mmHg) using a standard blood pressure cuff."},{"outcome_type":"primary","measure":"Change in Cortisol Dynamics","time_frame":"Measurements will be made before each walk of each condition (nature vs suburban).","description":"Diurnal cortisol dynamics measured by salivary cortisol (ug/dl), as the normal drop in cortisol during the day is attenuated by exposure to chronic stress."},{"outcome_type":"primary","measure":"Change in Cytokine Blood Concentration","time_frame":"Measurements will be made before each walk of each condition (nature vs suburban).","description":"Pro- and anti-inflammatory cytokine concentrations in blood (pg/mL), as stress typically induces an inflammatory response. Blood samples are collected by pricking the subject's finger-tip, collecting drops of blood on Protein SaverTMpaper (Whatman) and then drying the blood spots. The dried blood spots (DBS) are frozen and stored until assayed."},{"outcome_type":"primary","measure":"Change in Attention restoration","time_frame":"Measurements will be made at baseline one-week before the first walk, immediately before and after each walk, and within three days following the third walk of each condition (nature vs suburban).","description":"The Backward Digit Span test is one of the oldest tests used to evaluate working memory and is used to assess capacity to direct attention (i.e., attention restoration)."},{"outcome_type":"primary","measure":"Change in CESD","time_frame":"Measurements will be made at baseline, immediately before and after each walk of each condition (nature vs suburban).","description":"CESD: Stress is strongly associated with depression. To measure depressive symptoms we will use the Center for Epidemiological Studies Depression Scale (CESD). Scores are determined by summing the participants' answers to all 20 items from 1 (\"less than 1 day\") to 4 (\"5-7 days\") pre- and post-walk in each intervention location (nature vs suburban)."},{"outcome_type":"primary","measure":"Change in STAI","time_frame":"Measurements will be made at baseline, immediately before and after each walk of each condition (nature vs suburban).","description":"Anxiety: Stress is associated with increased levels of anxiety. Anxiety will be measured using the State and Trait Anxiety Inventories (STAI). Scores are determined by summing the participants' answers to all 20 items from 1 (\"not at all\") to 4 (\"frequently so\") pre- and post-walk in each intervention location (nature vs suburban)."},{"outcome_type":"primary","measure":"Change in Perceived stress","time_frame":"Measurements will be made at baseline, immediately before and after each walk of each condition (nature vs suburban).","description":"Perceived stress: Cohen's perceived stress scale (PSS) will be used to measure the extent to which subjects assess the events and situations in their lives to be stressful. Scores are determined by summing the participants' answers to all 10 items from 1 (\"never\") to 4 (\"very often\") pre- and post-walk in each intervention location (nature vs suburban)."}]}
{"nct_id":"NCT03543215","start_date":"2017-07-13","enrollment":500,"brief_title":"Can Staging Magnetic Resonance Imaging (MRI) Features Prognosticate Patients Presenting With Endometrial Cancer?","official_title":"Can Staging Magnetic Resonance Imaging (MRI) Features Prognosticate Patients Presenting With Endometrial Cancer?","primary_completion_date":"2021-12-10","study_type":"Observational","rec_status":"Recruiting","completion_date":"2025-12-10","last_update":"2021-02-12","description":"Aim: Assess the value of MRI features in predicting prognosis in patients with endometrial cancer This study will examine the MRI features of women with confirmed endometrial cancer to see if textural features can prognosticate patients.","other_id":"16HH3687 Radiomics EC","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"Female","minimum_age":18,"population":"All patients reviewed at the Specialist Gynaecology Oncology MDT at ICHNT with a diagnosis\r\n        of endometrial cancer","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  All women presenting with a confirmed diagnosis of endometrial cancer\r\n\r\n          -  Reviewed at the Specialist Gynaecology Oncology MDT\r\n\r\n          -  Have MR Imaging and Hysterectomy specimens available for review.\r\n\r\n        Exclusion criteria:\r\n\r\n          -  Anyone lacking capacity.\r\n\r\n          -  <18years old.\r\n\r\n          -  Pregnant.\r\n\r\n          -  No MR Imaging available for review -- No pathology specimen available for review\r\n      ","sponsor":"Imperial College London","sponsor_type":"Other","conditions":"Endometrial Cancer|Endometrial Neoplasms","interventions":[{"intervention_type":"Other","name":"Other: Radiomics: Analysis of textural features of imaging (MRI and Ultrasound)","description":"All patients with confirmed endometrial cancer will have received Ultrasound and MRI as part of routine standard of care. Textural features from this will be analysed to see if can predict prognosis."}],"outcomes":[{"outcome_type":"primary","measure":"To assess the value of MRI features in predicting prognosis in patients with endometrial cancer using progression free survival (PFS) and overall survival (OS) as end points","time_frame":"8 years (3 year data collection and 5 year follow up).","description":"Assess features of pelvic MRIs (including (i) tumour image intensity, (II) shape, (III) texture and (IV) multiscale wavelet) and create a mathematical algorithm to predict prognostic outcome (5 year survival)."},{"outcome_type":"secondary","measure":"Assess the correlation between imaging features and histopathological features.","time_frame":"3 years","description":"Assess textural features of pelvic MRI in conjunction with histopathology (type of tumour, grade LVSI, 'aggressiveness' of cancer"}]}
{"nct_id":"NCT04672057","start_date":"2017-07-08","phase":"N/A","enrollment":108,"brief_title":"Investigation of the Spatio-temporal Gait Parameters in Individuals With Hemiparesis: Effect of Lateralization","official_title":"Investigation of the Spatio-temporal Gait Parameters in Individuals With Hemiparesis: Effect of Lateralization","primary_completion_date":"2018-05-08","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-06-21","last_update":"2020-12-17","description":"The aim of this study was to investigate the effect of lateralization on the spatio-temporal characteristics of gait in individuals with hemiparesis.","other_id":"Gait Parameter In Hemiparetics","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        for the hemiparetic individuals\r\n\r\n          -  Being between the ages of 20-65,\r\n\r\n          -  Having a stroke for the first time and one-sidedly,\r\n\r\n          -  Having a stable clinical state,\r\n\r\n          -  Having no cognitive disorder (Hodkinson Mental Test  8),\r\n\r\n          -  Having  3 from Modified Rankin Score,\r\n\r\n          -  Having no problems with vision and hearing.\r\n\r\n        for the healthy control group;\r\n\r\n          -  Being between the ages of 20-65\r\n\r\n          -  Having no neurological, musculosceletal, cardiac and cognitive problems that was\r\n             undergone before and may affect walking.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  The existence of vision and hearing problems in both study and control groups,\r\n\r\n          -  The existence of orthopedic, neurological and psychiatric problems that may affect\r\n             walking.\r\n      ","sponsor":"Pamukkale University","sponsor_type":"Other","conditions":"Hemiparesis","interventions":[{"intervention_type":"Other","name":"Other: assessment of gait parameters","description":"Gait parameters have been recourded with the use of BTS G-Walk Wireless Digital Walking Analysis System on a 10-meter smooth walking area."}],"outcomes":[{"outcome_type":"primary","measure":"assessment of gait between in right and left hemiparetics","time_frame":"Measurement time is 10 minutes. Only one measurement was made.","description":"A port was attached to the patient's L5-S1 level. In the gait analysis system, the results was transferred to the computer via bluetooth with the analysis port. The resulting report was generated automatically. The report measured gait speed, cadence, right and left step length, right and left stride length, double and single stride length, pelvic rotation, pelvic tilt, and pelvic oblique."},{"outcome_type":"secondary","measure":"assessment of gait between in hemiparetic and healthy individuals","time_frame":"Measurement time is 10 minutes. Only one measurement was made.","description":"A port was attached to the patient's L5-S1 level. In the gait analysis system, the results was transferred to the computer via bluetooth with the analysis port. The resulting report was generated automatically. The report measured gait speed, cadence, right and left step length, right and left stride length, double and single stride length, pelvic rotation, pelvic tilt, and pelvic oblique."}]}
{"nct_id":"NCT03780933","start_date":"2017-07-05","phase":"N/A","enrollment":40,"brief_title":"the Effect of High Dose Ascorbic Acid on Critically Ill Patients With ARDS","official_title":"The Impact of High Dose Vitamin C \"Ascorbic Acid\" on the Clinical Outcomes of Critically Ill Patients With Acute Respiratory Distress Syndrome","primary_completion_date":"2019-06-20","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-06-20","last_update":"2019-10-02","description":"1. To access role of vitamin C supplementation in ARDS patients on the following: Oxidants/ antioxidants imbalance Length of hospital stay Mortality rate Weaning from mechanical ventilator Incidence of adverse drug reaction 2. To access tolerability of vitamin C supplementation in patients with ARDS.","other_id":"247","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. All ARDS cases presenting to the Chest department ICU within 48 hours of diagnosis\r\n\r\n          2. who don't have an exclusion criteria will be included.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Known allergy to Vitamin C\r\n\r\n          2. Inability to obtain consent;\r\n\r\n          3. Age < 18 years;\r\n\r\n          4. More than 48 hours since meeting ARDS criteria;\r\n\r\n          5. Pregnancy or breast feeding,\r\n\r\n          6. Moribund patient not expected to survive 24 hours;\r\n\r\n          7. Patients not eligible to CPR\r\n\r\n          8. Active kidney stone\r\n      ","sponsor":"Misr International University","sponsor_type":"Other","conditions":"Acute Respiratory Distress","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: vitamin c","description":"vitamin c IV 10 G"}],"outcomes":[{"outcome_type":"primary","measure":"Assessment of Improvement in ARDS patient's mortality rate","time_frame":"within 10 days of ARDS diagnosis","description":"Days to weaning from ventilator"},{"outcome_type":"secondary","measure":"Intensive Care Unit Length of Stay","time_frame":"subject will be followed until discharged from the ICU, has deceased, or study duration has reached 10days from time of enrollment, whichever is first","description":"improvement in clinical outcome"},{"outcome_type":"secondary","measure":"Duration of Mechanical Ventilation","time_frame":"subject will be followed until mechanical ventilation has been discontinued, the subject has deceased, or study duration has reached 10 days from time of enrollment, whichever is first","description":"improvement in respiratory functions"}]}
{"nct_id":"NCT03205774","start_date":"2017-07-03","phase":"N/A","enrollment":25,"brief_title":"Positioning and Ultrasound Examination of the Gastric Antrum","official_title":"Effect of Positioning on Ultrasound Examination of the Gastric Antrum","primary_completion_date":"2018-01-20","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-01-20","last_update":"2018-05-07","description":"The aim of this prospective study was to assess the effect of patient positioning on the ultrasound assessment of gastric contents.","other_id":"L16-190","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Diagnostic","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  ASA 1 and 2 volunteers\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Diabetes mellitus\r\n\r\n          -  previous gastrointestinal surgery\r\n\r\n          -  Medication affecting gastric motility\r\n\r\n          -  digestive diseases, gastroparesis\r\n\r\n          -  Pregnancy\r\n      ","sponsor":"Hpital Edouard Herriot","sponsor_type":"Other","conditions":"Gastric Ultrasound","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: 6 hours fasting and free oral intake of water","description":"Ultrasound examination of the gastric antrum are performed in volunteers after prolonged fasting and 10 min after oral intake of water. Volunteer should be lying on his/her back, right lateral decubitus position and left lateral decubitus position with randomization of the order."}],"outcomes":[{"outcome_type":"primary","measure":"Change in ultrasound measurement of the antral cross sectional area according to the position","time_frame":"through study completion, an average of 20 min","description":"Ultrasound measurement of antral cross-sectional area"},{"outcome_type":"primary","measure":"Change in qualitative ultrasound assessment of gastric contents according to the position","time_frame":"through study completion, an average of 20 min","description":"qualitative ultrasound assessment of gastric contents"}]}
{"nct_id":"NCT03197012","start_date":"2017-07-01","phase":"Early Phase 1","enrollment":10,"brief_title":"Yttrium-90 DOTA-TOC Intra-arterial (IA) Peptide Receptor Radionuclide Therapy (PRRT) for Neuroendocrine Tumor","official_title":"Yttrium-90 DOTA-TOC Intra-arterial (IA) Peptide Receptor Radionuclide Therapy (PRRT) for Neuroendocrine Tumor","primary_completion_date":"2019-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-05-31","last_update":"2020-07-07","description":"This is a prospective, pilot, single center, open-label study in patients with metastatic neuroendocrine tumor. Eligible participants will undergo baseline assessments at enrollment. Study participants will receive a one-time administration of 90Y-DOTA-TOC via the hepatic artery. Participants in the correlative sub-study will receive 68Ga-DOTA-TOC concurrent with the 90Y-DOTA-TOC dose, and undergo additional imaging and assessment.","other_id":"17455","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Main study: All participants will receive a single administration of intra-arterial 90Y-DOTA-TOC.\r\nThere will be a sub-study involving 10 patients from the main study who will undergo additionally correlative imaging to compare IA vs IV administration (intra-arterial 68Ga-DOTA-TOC administration and subsequent PET imaging).","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        1. Biopsy proven neuroendocrine tumor, which is somatostatin receptor positive as\r\n        demonstrated on somatostatin receptor Positron Emission Tomography (PET).\r\n\r\n          1. All sites or origin are eligible.\r\n\r\n          2. Functional and nonfunctional tumors are allowed. 2. Hepatic metastases on imaging\r\n             meeting the following criteria:\r\n\r\n        a. Liver-only or liver-dominant metastases, defined as: i. At least 10% liver parenchyma\r\n        replacement by tumor, but less than 70% replacement of the hepatic parenchyma by tumor.\r\n\r\n        1. For the imaging sub-study: at least one liver lesion must measure greater than 2 cm in\r\n        size 2. For the imaging sub-study: treatment must only be performed using a single dose,\r\n        and so arterial variant anatomy that would result in a split treatment will not be allowed\r\n        ii. And, progression of the liver metastases demonstrated within the past twelve months\r\n        defined as either:\r\n\r\n          1. Appearance of any new liver lesion or\r\n\r\n          2. 20% increase in size of at least one liver lesion. iii. Presence of low-volume\r\n             extrahepatic lesions (including primary tumor) is allowed if they are stable and\r\n             asymptomatic.\r\n\r\n             b. SUVmax on 68Ga-DOTA-TOC PET of the liver metastases two times greater than the\r\n             adjacent liver parenchyma.\r\n\r\n          3. Not a candidate for surgical debulking.\r\n\r\n          4. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2\r\n\r\n          5. Age > 18.\r\n\r\n          6. Ability to understand a written informed consent document, and the willingness to sign\r\n             it.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients not capable of getting PET study due to weight, claustrophobia, or inability\r\n             to lie still for the duration of the exam.\r\n\r\n             a. For patients in the imaging correlate sub-study: contraindication for undergoing\r\n             MRI based on University of California, San Francisco (UCSF) Radiology guidelines.\r\n\r\n          2. Contraindication to hepatic arteriography (e.g. hepatic artery dissection and/or\r\n             thrombosis, uncorrectable coagulopathy, severe allergy to iodinated contrast, severe\r\n             vascular disease precluding safe hepatic artery catheterization).\r\n\r\n          3. Any patient receiving treatment with short-acting octreotide, which cannot be\r\n             interrupted for 48 hours before and 24 hours after the administration of 90Y-DOTA-TOC,\r\n             or any patient receiving treatment with octreotide long-acting release (LAR) or\r\n             lanreotide, which cannot be interrupted for at least 4 weeks before the administration\r\n             of 90Y-DOTA-TOC.\r\n\r\n             a. Concurrent somatostatin receptor analog (SSA) allowed if progression has been\r\n             documented and the SSA dose has been stable for at least two months. Long-acting SSA\r\n             cannot be given within four weeks of treatment and short-acting SSA cannot be given\r\n             with 48 hours of treatment. SSA therapy can restart one day after treatment.\r\n\r\n          4. Interferon, everolimus (mTOR-inhibitors), sunitinib or other systemic therapies within\r\n             4 weeks prior to enrollment. Bevacizumab within 6 weeks prior to enrollment.\r\n\r\n          5. Any liver directed treatment (surgery, radioembolization, chemoembolization,\r\n             chemotherapy and radiofrequency ablation) within 12 weeks prior to enrollment.\r\n\r\n          6. Any external beam radiation treatment for hepatic disease. Prior external beam\r\n             radiation therapy to more than 25% of the bone marrow.\r\n\r\n             a. Prior systemic PRRT treatment is allowed, if it was performed at least six months\r\n             prior.\r\n\r\n          7. Pregnancy or lactation. Women of childbearing potential and men must agree to use\r\n             adequate contraception prior to study entry and for the duration of study\r\n             participation\r\n\r\n          8. Impaired liver function\r\n\r\n               1. aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT))\r\n                  / alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase (SGPT)) > 3\r\n                  x upper limit of normal (ULN).\r\n\r\n               2. Total bilirubin >1.5 x ULN\r\n\r\n               3. Serum albumin <3.0 g/dL unless prothrombin time is within the normal range.\r\n\r\n               4. Thrombosis of the main portal vein\r\n\r\n               5. Clinical evidence of ascites (trace ascites on imaging acceptable).\r\n\r\n          9. Impaired bone marrow reserve\r\n\r\n               1. Hb concentration < 8.0 g/dL;\r\n\r\n               2. Total White Blood Cell count (WBC) <2x109/L (2000/mm3);\r\n\r\n               3. Platelets <75x109/L (75x103/mm3).\r\n\r\n         10. Creatinine clearance <50 mL/min calculated by the Cockroft Gault method.\r\n\r\n         11. Known intracranial metastases.\r\n      ","sponsor":"Thomas Hope","sponsor_type":"Other","conditions":"Neuroendocrine Tumor","interventions":[{"intervention_type":"Drug","name":"Drug: 90Y-DOTA-TOC","description":"Starting 30 minutes prior to the administration of 90Y-DOTA-TOC, amino acid solution will be administered via IV, and will continue through the PRRT procedure. An angiographic catheter will be inserted under fluoroscopic guidance to the appropriate location in the hepatic artery. 90Y-DOTA-TOC will be administered via the hepatic arterial catheter."},{"intervention_type":"Drug","name":"Drug: 68Ga-DOTA-TOC","description":"In the sub-study, 10 patients will receive 68Ga-DOTA-TOC concurrent with the 90Y-DOTA-TOC dose and 90 minutes after treatment, these patients will be imaged using a PET/CT. The following day, patients enrolled in the sub-study will undergo a PET/MRI."}],"outcomes":[{"outcome_type":"primary","measure":"Overall Response Rate (ORR)","time_frame":"Over the duration of the study, which is estimated to be approximately 36 months","description":"Based on change in size of hepatic lesions three and six months after treatment with IA 90Y-DOTA-TOC using RECIST criteria."},{"outcome_type":"primary","measure":"Incidence of Treatment-Related Adverse Events [Safety]","time_frame":"Over the duration of the study, which is estimated to be approximately 36 months","description":"Based on laboratory evaluation and CTCAE 4.0 criteria."},{"outcome_type":"secondary","measure":"Change in SUVmax between pre-treatment IV 68Ga-DOTA-TOC PET and treatment IA 68Ga-DOTA-TOC.","time_frame":"Over the duration of the study, which is estimated to be approximately 36 months","description":"Data from patients in the imaging correlate sub-study only"},{"outcome_type":"secondary","measure":"Correlation between uptake on IA 68Ga-DOTA-TOC PET/CT compared to 24-hour post-treatment IA 90Y-DOTA-TOC PET/MRI.","time_frame":"Over the duration of the study, which is estimated to be approximately 36 months","description":"Data from patients in the imaging correlate sub-study only"}]}
{"nct_id":"NCT03018106","start_date":"2017-06-30","phase":"Phase 4","enrollment":1,"brief_title":"Ospemifene vs. Conjugated Estrogens in the Treatment of Postmenopausal Sexual Dysfunction","official_title":"Ospemifene Versus Conjugated Estrogens in the Treatment of Postmenopausal Sexual Dysfunction","primary_completion_date":"2017-09-29","study_type":"Interventional","rec_status":"Terminated","completion_date":"2017-09-29","last_update":"2018-01-23","description":"Vulvovaginal atrophy (VVA) is a condition that impacts up to 60% of the growing postmenopausal female population, and the most common symptom is dyspareunia. Vaginal estrogen is the most common treatment for VVA, but it only marginally improves overall sexual function, and many women and clinicians avoid using it because of the risks of exogenous estrogen use during menopause. Ospemifene is a non-estrogen selective estrogen receptor modulator (SERM) that is FDA-approved for treating dyspareunia related to VVA, and has shown superb improvements in overall sexual health. 104 women will be randomized to receive 12 weeks of 60mg oral ospemifene, taken daily, or 12 weeks of 0.5mg vaginal conjugated estrogens, which is placed vaginally twice per week. The improvements in sexual health and VVA symptom severity will be compared in each group. This study will help determine if ospemifene is a better treatment medication than conjugated estrogens.","other_id":"IRB00088077","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Interested in resuming or continuing sexual activity\r\n\r\n          -  Greater than 12 months since last menstrual cycle or prior bilateral oophorectomy\r\n\r\n          -  Dyspareunia as a vulvovaginal atrophy symptom\r\n\r\n          -  Normal mammogram within 12 months prior to entry into the study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History or suspicion of breast carcinoma\r\n\r\n          -  History of hormone-dependent tumor\r\n\r\n          -  Genital bleeding of unknown cause\r\n\r\n          -  Ongoing vaginal infection\r\n\r\n          -  History of cerebrovascular accident (CVA), myocardial infarction (MI) or heart disease\r\n\r\n          -  Uncontrolled hypertension (HTN) over 160/100\r\n\r\n          -  Serious disease or chronic condition that may prevent completion of study\r\n\r\n          -  Body Mass Index (BMI) over 40\r\n\r\n          -  Hypercoagulable state, or currently on anticoagulant therapy\r\n\r\n          -  Use of any exogenous sex hormone within three months from study entry, or during the\r\n             study\r\n\r\n          -  Pelvic surgery within the last 12 months\r\n      ","sponsor":"Emory University","sponsor_type":"Other","conditions":"Sexual Dysfunction, Physiological","interventions":[{"intervention_type":"Drug","name":"Drug: Ospemifene","description":"Ospemifene is a selective estrogen receptor modulator (SERM), and it is the only SERM approved in the United States to treat moderate to severe dyspareunia associated with VVA. It is an oral medication that is taken as a 60mg tablet once daily. Food intake increases its absorption by 2 to 3-fold, and this is not impacted by the fat or calorie content of the food. It is metabolized primarily in the liver, and is excreted in feces."},{"intervention_type":"Drug","name":"Drug: Vaginal conjugated estrogens","description":"Conjugated estrogens are a mixture of several different estrogen salts derived from natural sources and blended to approximate the composition of estrogens in the urine of pregnant horses. The main components are sodium estrone sulphate and sodium equilin sulfate. Vaginal estrogen is considered the medication of choice for treating vulvovaginal atrophy (VVA)."}],"outcomes":[{"outcome_type":"primary","measure":"Female Sexual Function Index Score","time_frame":"Baseline, Week 12","description":"The Female Sexual Function Index (FSFI) is a 19 item questionnaire that asks about sexual function in the prior four weeks. The FSFI was developed for the specific purpose of assessing sexual arousal, orgasm, satisfaction, pain related to sexual functioning in clinical trial participants. Participants answer by selecting between 5-6 question-specific options to rate the degree to which the question fits their experience. Each response option is assigned a point and each question has 0-5 or 1-5 possible points. The points are summed to determine a total score. The total score can range from 2 to 36 and scores equal to or less than 26.55 indicate female sexual dysfunction (FSD)."},{"outcome_type":"primary","measure":"Pain With Sex","time_frame":"Baseline, Week 12","description":"Participants reported pain with sex at the Baseline Visit and after 12 weeks of treatment. Participants rated the severity of their symptoms from 0 to 3, where 0 = none, 1 = mild, 2 = moderate and 3 = severe."},{"outcome_type":"primary","measure":"Vaginal Dryness","time_frame":"Baseline, Week 12","description":"Participants reported vaginal dryness at the Baseline Visit and after 12 weeks of treatment. Participants rated the severity of their symptoms from 0 to 3, where 0 = none, 1 = mild, 2 = moderate and 3 = severe."},{"outcome_type":"primary","measure":"Vaginal Itching","time_frame":"Baseline, Week 12","description":"Participants reported vaginal itching at the Baseline Visit and after 12 weeks of treatment. Participants rated the severity of their symptoms from 0 to 3, where 0 = none, 1 = mild, 2 = moderate and 3 = severe."},{"outcome_type":"primary","measure":"Vaginal Irritation","time_frame":"Baseline, Week 12","description":"Participants reported vaginal irritation at the Baseline Visit and after 12 weeks of treatment. Participants rated the severity of their symptoms from 0 to 3, where 0 = none, 1 = mild, 2 = moderate and 3 = severe."}]}
{"nct_id":"NCT03197558","start_date":"2017-06-27","phase":"Phase 2","enrollment":30,"brief_title":"Adult Study to Evaluate Placement of Tympanostomy Tubes In-office (ADEPT)","official_title":"A Prospective, Multicenter Study to Evaluate Effectiveness and Safety of Lidocaine Iontophoresis and Tympanostomy Tube Placement Using the Tula Iontophoresis and Tube Delivery Systems for Adults in an Office Setting","primary_completion_date":"2017-09-14","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-09-14","last_update":"2020-01-18","description":"A prospective, multicenter study to evaluate effectiveness and safety of Tymbion iontophoresis and tympanostomy tube placement using the Tula iontophoresis and tube delivery systems for adults in an office setting. This study cohort is called Group B and includes tube placement. Protocol CPR007003 also included a first study group ('A', without tube placement) that was completed and described in a separate registration (NCT03119181).","other_id":"CPR007003 - Group B","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Adults at least 18 years of age at time of consent\r\n\r\n          2. Indication for tympanostomy tube insertion per Clinical Practice Guideline,or\r\n             indicated for tympanostomy tube insertion due to barotrauma or Eustachian tube\r\n             dysfunction per AAO-HNS Clinical Indicators.\r\n\r\n          3. Subject is able and willing to comply with the protocol and attend all study visits.\r\n\r\n          4. Subject is able and willing to provide informed consent.\r\n\r\n          5. Subject is able to read and understand English.\r\n\r\n        Exclusion Criteria by Ear:\r\n\r\n          1. Significantly atrophic, retracted or retraction pocket at location of tube placement,\r\n             bimeric, monomeric or atelectatic tympanic membrane.\r\n\r\n          2. Perforated tympanic membrane.\r\n\r\n          3. Otitis externa.\r\n\r\n          4. Hemotympanum.\r\n\r\n          5. Damaged/denuded skin in the auditory canal.\r\n\r\n          6. Cerumen impaction resulting in a significant amount of cleaning required to visualize\r\n             the tympanic membrane potentially causing abrasion or irritation to the external ear\r\n             canal.\r\n\r\n          7. Notable ear discomfort experienced during audiologic or otoscopic examination.\r\n\r\n          8. Anatomy that precludes sufficient visualization of and access to the tympanic\r\n             membrane.\r\n\r\n          9. Anatomy that necessitates tympanostomy tube placement in the posterior half of the\r\n             tympanic membrane.\r\n\r\n             General Exclusion Criteria\r\n\r\n         10. Pregnant or lactating females\r\n\r\n         11. History of sensitivity or allergic reaction to lidocaine HCl, tetracaine, epinephrine,\r\n             or any hypersensitivity to local anesthetics.\r\n\r\n         12. Familial history of insensitivity to lidocaine or other local anesthetics of the amide\r\n             type.\r\n\r\n         13. Electrically sensitive medical support systems (eg, pacemakers, defibrillators,\r\n             cochlear implants)\r\n\r\n         14. Other conditions that would preclude performing the study procedure including\r\n             iontophoresis system ear plug incompatibility.\r\n\r\n         15. Health conditions that, in the opinion of the investigator, would present undue risk\r\n             to the subject, based on device/anesthetic drug product label warnings and precautions\r\n      ","sponsor":"Tusker Medical","sponsor_type":"Industry","conditions":"Barotrauma;Ear|OME - Otitis Media With Effusion|AOM - Acute Otitis Media|Eustachian Tube Dysfunction","interventions":[{"intervention_type":"Combination Product","name":"Combination Product: Tymbion Iontophoresis and Tube Delivery System (TDS)","description":"Subjects will receive active Tymbion iontophoresis and tube insertion using the Tube Delivery System in all ears indicated for tube placement."}],"outcomes":[{"outcome_type":"primary","measure":"Subject-reported Pain Score Following Tube Delivery System (TDS) Tube Placement Using the Visual Analogue Scale (VAS) by Subject Compared to a Performance Goal.","time_frame":"Day of procedure (Day 0)- Immediately after tube placement","description":"The VAS consists of a 100 millimeter (mm) line with a statement at each end representing the extreme limits of pain intensity where a score of 0 represents \"No pain\" and a score of 100 represents \"The worst possible pain\".\r\nFollowing TDS tube placement, the subject will report their post-tube placement ear discomfort for each ear undergoing tube placement using the VAS. For subjects treated bilaterally, the highest (worst) score reported will be used as the unit of analysis."}]}
{"nct_id":"NCT03583580","start_date":"2017-06-19","phase":"N/A","enrollment":537,"brief_title":"Accelerated Partial Breast Irradiation With IMRT in Early Breast Cancer","official_title":"A Multicenter Phase  Prospective Clinical Trial of Accelerated Partial Breast Irradiation With IMRT After Breast-conserving Surgery in Early Breast Cancer","primary_completion_date":"2021-12-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2024-06-30","last_update":"2020-11-12","description":"This study is to evaluate the efficacy and toxicity of accelerated partial breast irradiation (ABPI) with intensity modulated radiation therapy (IMRT) in low-risk breast cancer treat with breast-conserving surgery.","other_id":"NCC201804006","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":45,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Life Expectation: > 5 years\r\n\r\n          -  Enrollment date no more than 12 weeks after breast-conserving surgery or no more than\r\n             8 weeks after adjuvant chemotherapy\r\n\r\n          -  Histologically confirmed diagnosis of invasive ductal carcinoma (grade 1-2), or\r\n             mucinous carcinoma, or papillary carcinoma, or tubular carcinoma, or medullary\r\n             carcinoma: primary tumor  3.0cm in maximum diameter and pN0; or histologically\r\n             confirmed DCIS: primary tumor  2.5cm in maximum diameter, low-medium grade\r\n\r\n          -  Unifocal tumour (confirmed by diagnostic MRI)\r\n\r\n          -  No lymphovascular invasion\r\n\r\n          -  ER positive (defined as medium-strongly nuclear staining in >1% of the cancer cells)\r\n\r\n          -  Negative radial resection margins of >= 2 mm\r\n\r\n          -  Surgical clips placed in the tumor bed\r\n\r\n          -  Written informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Stage -\r\n\r\n          -  Multifocal tumors\r\n\r\n          -  Histologically confirmed diagnosis of invasive ductal carcinoma (grade 3), invasive\r\n             micropapillary carcinoma, carcinoma of lobular in situ, invasive lobular carcinoma\r\n\r\n          -  Paget's disease of the nipple\r\n\r\n          -  Underwent oncoplastic surgery of ipsilateral breast\r\n\r\n          -  Underwent neoadjuvant chemotherapy or hormonal therapy\r\n\r\n          -  Previous or simultaneous contralateral breast cancer\r\n\r\n          -  Undergone ipsilateral chest wall radiotherapy\r\n\r\n          -  Active collagen vascular disease.\r\n      ","sponsor":"Chinese Academy of Medical Sciences","sponsor_type":"Other","conditions":"Breast Neoplasms|Neoplasm Recurrence, Local","interventions":[{"intervention_type":"Radiation","name":"Radiation: Accelerated Partial Breast Irradiation","description":"Patients are irradiated to the region of tumour bed using intensity modulated radiation therapy (IMRT)"}],"outcomes":[{"outcome_type":"primary","measure":"locoregional control rate","time_frame":"5 years","description":"ipsilateral breast and axilla nodal relapse rate"},{"outcome_type":"secondary","measure":"overall survival","time_frame":"5 years","description":"any death"},{"outcome_type":"secondary","measure":"disease-free survival","time_frame":"5 years","description":"any recurrence or death"},{"outcome_type":"secondary","measure":"distant-metastasis survival","time_frame":"5 years","description":"distant metastasis"},{"outcome_type":"other","measure":"acute and late adverse events assessed by CTCAE v4.0","time_frame":"5 years","description":"acute skin toxicity,breast swelling, breast pain,radiation pneumonitis, cardiac toxicity, pulmonary fibrosis, cosmetic result"},{"outcome_type":"other","measure":"quality of life measured with BR-23 questionnaire","time_frame":"2 years","description":"BR-23 questionnaire"},{"outcome_type":"other","measure":"the incidence of second malignancy","time_frame":"5 year","description":"pathologically diagnosis of contralateral breast cancer and other malignant tumors after radiotherapy"}]}
{"nct_id":"NCT03452306","start_date":"2017-06-15","phase":"Phase 1","enrollment":28,"brief_title":"Bioequivalence Study of Metformin 750 mg Tablets XR Versus Glucophage Long 750 mg Tablets XR In Normal Healthy Subjects Under Fasting and Fed Conditions","official_title":"Four-way Crossover, Open-label, Single-dose, Bioequivalence Study of Metformin (LLC \"GEROPHARM\", Russia) 750 mg Tablets Extended Release Versus Glucophage Long (Merck Sant S.A.S, France) 750 mg Tablets Extended Release in Normal Healthy Subjects Under Fasting and Fed Conditions","primary_completion_date":"2017-07-22","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-07-22","last_update":"2018-07-03","description":"Bioequivalence Study of 2 formulation of metformin (Metformin GEROPHARM vers. Glucophage Long Merck )","other_id":"BIOMET-LONG","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","intervention_model_description":"four-way crossover","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Signed informed consent form.\r\n\r\n          -  Healthy male and female subjects aged 18 to 45 years.\r\n\r\n          -  Verified diagnosis is \"healthy\" according to data Standard clinical, laboratory and\r\n             Instrumental methods of examination.\r\n\r\n          -  Have a body mass index between 18,5 and 27 kg/m2.\r\n\r\n          -  Females must have a negative pregnancy test.\r\n\r\n          -  Subjects must use, with their partner, methods of highly effective contraception\r\n             throughout the study and 30 days after the end of study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of serious allergic problems/events\r\n\r\n          -  Medicinal intolerance.\r\n\r\n          -  History of allergic reactions to memantine or investigator's product components\r\n\r\n          -  Any acute and chronic diseases of the cardiovascular system, cardiovascular,\r\n             bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal\r\n             tract, liver, kidneys, blood.\r\n\r\n          -  Acute infectious diseases in less than 4 weeks before the start of the study.\r\n\r\n          -  Subjects who have taken medication 4 weeks preceding before the study.\r\n\r\n          -  Subjects who have taken any drugs known effects on hemodynamics or to induce or\r\n             inhibit hepatic drug metabolism within 30 days prior to administration of the study\r\n             medication (examples of inducers: barbiturates, omeprazole, etc.).\r\n\r\n          -  Donation of plasma (450 mL or more) within 2 month prior to administration of the\r\n             study medication.\r\n\r\n          -  History of significant alcohol or drugs abuse or any indication of the regular use of\r\n             more than 10 units of alcohol per week (1 Unit = 200 mL of wine or 500 mL of beer or\r\n             50 mL of alcohol 40%).\r\n\r\n          -  Smokers.\r\n\r\n          -  Participation in other clinical training is less than than for 3 months before the\r\n             study.\r\n\r\n          -  Lack of signed informed consent form.\r\n\r\n          -  ECG or vital signs abnormalities (clinically significant).\r\n\r\n          -  Positive testing for alcohol, drugs, pregnancy.\r\n\r\n          -  Dehydration due to diarrhea, vomiting, or other causes within the last 24 hours before\r\n             the start of the study.\r\n\r\n          -  Any diet, for example, vegetarian, for 2 weeks before taking the study medications.\r\n\r\n          -  Women with preserved reproductive potential who have unprotected sexual intercourse\r\n             with an unsterilized male partner within 30 days prior to taking the study medication.\r\n\r\n          -  Heart rate below 60 or above 80 beats per minute.\r\n\r\n          -  Systolic blood pressure less than 110 mm Hg or more than 139 mm Hg.\r\n\r\n          -  Diastolic blood pressure less than 70 mm Hg or more than 89 mm Hg.\r\n      ","sponsor":"Geropharm","sponsor_type":"Industry","conditions":"Bioequivalence","interventions":[{"intervention_type":"Drug","name":"Drug: Metformine","description":"First aIntervention Period:\r\nSingle administered dose of Metformin (750 mg tablet extended-release) in a fasting condition"},{"intervention_type":"Drug","name":"Drug: Metformin","description":"Third Intervention Period:\r\nSingle administered dose of Metformin (750 mg tablet extended-release) in a fed condition"},{"intervention_type":"Drug","name":"Drug: Glucophage Long","description":"Second Intervention Period:\r\nSingle administered dose of Glucophage (750 mg tablet extended-release) in a fasting condition"},{"intervention_type":"Drug","name":"Drug: Glucophage Long","description":"Fourth Intervention Period:\r\nSingle administered dose of Metformin (750 mg tablet extended-release) in a fed condition"}],"outcomes":[{"outcome_type":"primary","measure":"Cmax","time_frame":"0 hours (pre-dose), as well as at 0.5, 1.0, 2.0, 3.0, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0, 12.0, 16.0, 20.0, 24.0, 30.0 and 36 hours post-dose","description":"Pharmacokinetics of metformin by Assessment of Observed Maximum Plasma Concentration (Cmax)"},{"outcome_type":"primary","measure":"AUC(0-t)","time_frame":"0 hours (pre-dose), as well as at 0.5, 1.0, 2.0, 3.0, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0, 12.0, 16.0, 20.0, 24.0, 30.0 and 36 hours post-dose","description":"Pharmacokinetics of metformin by Assessment of Area Under the Curve From Time Zero Extrapolated to \"t\" (AUC(0-t))"}]}
{"nct_id":"NCT03772509","start_date":"2017-06-14","phase":"N/A","enrollment":1511,"brief_title":"Use of Introduction Mode to Improve Interactive Voice Response Surveys in Bangladesh and Tanzania","official_title":"A Randomized Controlled Trial of Varying Introduction Mode to Improve Interactive Voice Response (IVR) Survey Performance in Bangladesh and Tanzania","primary_completion_date":"2017-08-18","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-08-18","last_update":"2018-12-11","description":"This study evaluates the effect of two different introduction modes on interactive voice response (IVR) survey cooperation, response, refusal, and contact rates, in Bangladesh and Tanzania.","other_id":"00007318-5","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"Single","intervention_model_description":"Participants were randomized to one of two introduction and consent modes: 1) computer-assisted telephone interviews, or 2) interactive voice response.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Access to a mobile phone\r\n\r\n          -  Greater or equal to 18 years of age\r\n\r\n          -  In Bangladesh, conversant in either English or Bangla language. In Uganda, conversant\r\n             in either Luo, Luganda, Runyakitara, or English languages.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Less than 18 years of age\r\n      ","sponsor":"Johns Hopkins Bloomberg School of Public Health","sponsor_type":"Other","conditions":"Surveys and Questionnaires|Noncommunicable Diseases","interventions":[{"intervention_type":"Other","name":"Other: CATI","description":"The participants in this arm were read the introduction and asked for consent by a call center employee using computer-assisted telephone interviewing and then were sent a noncommunicable disease risk factor survey via interactive voice response. This mode was used to motivate participants to complete the survey."}],"outcomes":[{"outcome_type":"primary","measure":"Cooperation Rate #1","time_frame":"Through study completion, an average of one month","description":"As defined by American Association for Public Opinion Research, cooperation rate is defined as I/(I+P+R) where I is complete interviews, P is partial interviews, and R is refusals and breakoffs."},{"outcome_type":"primary","measure":"Response Rate #4","time_frame":"Through study completion, an average of one month","description":"As defined by American Association for Public Opinion Research, response rate is defined as (I+P)/(I+P+R+eU) where I is complete interviews, P is partial interviews, R is refusals and breakoffs, and eU is the estimated eligible proportion of unknowns"},{"outcome_type":"secondary","measure":"Refusal Rate #2","time_frame":"Through study completion, an average of one month","description":"As defined by American Association for Public Opinion Research, refusal rate is defined as (R)/(I+P+R+eU) where R is refusals and breakoffs, I is complete interviews, P is partial interviews, and eU is the estimated eligible proportion of unknowns."},{"outcome_type":"secondary","measure":"Contact Rate #2","time_frame":"Through study completion, an average of one month","description":"As defined by American Association for Public Opinion Research, contact rate is defined as (I+P+R)/(I+P+R+eU) where I is complete interviews, P is partial interviews, R is refusals and breakoffs, and eU is the estimated eligible proportion of unknowns."}]}
{"nct_id":"NCT03156166","start_date":"2017-06-12","phase":"N/A","enrollment":89,"brief_title":"Distance From the Glottis to the Grille in Children","official_title":"Distance From the Glottis to the Grille in Children: Ambu AuraGainTM , I-gel, Air-Q Intubating Laryngeal Airway as Intubation Conduits","primary_completion_date":"2018-05-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-05-30","last_update":"2018-07-17","description":"Ambu AuraGain, I-gel, Air-Q intubating laryngeal airway are the most commonly used supraglottic airway. In children, they can be used as intubation conduits. However, there has been no guideline for optimal insertion depth of endotracheal tube through those supraglottic airway. In this study, the investigators will measure the distance from grille of those supraglottic airways to glottis using fiberoptic bronchoscope in children undergoing anesthesia. This distance allows us to predict an appropriate depth of endotracheal tube when it should be inserted through each supraglottic airway.","other_id":"H1704-133-848","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"All","maximum_age":7,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  children < 7 years old undergoing elective surgery\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  difficult airway\r\n\r\n          -  BMI> 30kg/m2\r\n\r\n          -  emergency operation\r\n\r\n          -  cervical spine disease\r\n\r\n          -  history of esophageal disease and surgery\r\n      ","sponsor":"Seoul National University Hospital","sponsor_type":"Other","conditions":"General Anesthesia","interventions":[{"intervention_type":"Procedure","name":"Procedure: fiberoptic bronchoscope","description":"Distance from grille (the end of shaft in supraglottic airway) to glottis is measured using FOB"}],"outcomes":[{"outcome_type":"secondary","measure":"Ventilation score","time_frame":"30 seconds after each supraglottic airway insertion","description":"no air leak in airway pressure of 15 cmH2O / bilateral chest wall movement/ normal waveform of capnography"},{"outcome_type":"primary","measure":"The distance from grille to glottis","time_frame":"30 seconds after each supraglottic airway insertion","description":"The distance from grille to glottis is measured using fiberoptic bronchoscopy"},{"outcome_type":"secondary","measure":"FOB view","time_frame":"30 seconds after each supraglottic airway insertion","description":"score 1: no visible glottis, score 2: visible glottis and anterior epiglottis, score 3: visible glottis and posterior epiglottis, and score 4: only glottis visible"}]}
{"nct_id":"NCT02832713","start_date":"2017-06-09","phase":"Phase 2","enrollment":50,"brief_title":"Trial Comparing Botulin Toxin Versus Hyaluronic Acid by Intra-articular Injection for the Treatment of Painful Knee Osteoarthritis","official_title":"Randomized Controlled Trial Comparing Botulin Toxin Versus Hyaluronic Acid by Intra-articular Injection for the Treatment of Painful Knee Osteoarthritis","primary_completion_date":"2021-10-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2021-12-31","last_update":"2021-09-14","description":"In France, osteoarthritis affects about 10 million people and knee osteoarthritis represents 35% of cases. It is thought that more than 2.5 million people older than 65 years have knee osteoarthritis. Currently, osteoarthritis management is based on three major axes: 1. Non-pharmacological means, such as patient education, loss of weight and physical activity 2. General pharmacological treatments: mainly paracetamol and then schedule II and III painkillers as well as nonsteroidal anti-inflammatory agent. 3. Intra-articular pharmacological treatments: 1. Intra-articular injections of corticosteroids: they are recommended during hydarthrotic flare-ups 2. Intra-articular injections of hyaluronic acid (HA) (viscosupplementation) in the absence of intra-articular effusion. However, their efficacy is questioned by most experts in the case of symptomatic knee osteoarthrosis. 4. Sometimes, surgery is the only therapeutic option. However, besides the fact of exposing patients, who are sometimes frail, to several peri- and post-operative complications, the recovery rate (variable according to the prosthesis type and ranging from 5% to 25% at 9 years) in an ageing population justifies waiting as much as possible before surgery. Therefore, it is important to test new therapeutic options for symptomatic osteoarthrosis that will allow postponing the surgical treatment. 5. The use of botulinum toxin (BoNT-A) could thus represents an interesting alternative. BoNT-A is habitually used by intra-muscular injection for its myorelaxant effect in the management of painful reactive periarticular muscle contractures. However, BoNT-A has also antalgic activity independently of the myorelaxant effect. This allows explaining in part the antalgic effect of intra-articular BoNT-A injection. In the literature, six randomized controlled studies (RCS) have compared BoNT-A and intra-articular injections of corticosteroids, hyaluronic acid, or placebo. Only two RCS concerned knee osteoarthritis and compared BoNT-A to corticosteroids and a placebo, respectively, with a significant antalgic effect only in the groups treated with BoNT-A. No study has compared yet the intra-articular injection of BoNT-A to the viscosupplementation by HA in knee osteoarthritis and this is the aim of this trial.","other_id":"6122","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Painful, or predominantly unilateral painful, knee osteoarthritis of any etiology\r\n\r\n          -  Knee without clinical signs of intra-articular effusion\r\n\r\n          -  Kellgren score  II on X-ray\r\n\r\n          -  WOMAC pain sub-score  5 in the month preceding the inclusion visit\r\n\r\n        Exclusion Criteria:\r\n\r\n        Clinical:\r\n\r\n          -  Inflammatory arthropathy,infectious, neoplastic within the past year\r\n\r\n          -  Neuromuscular pathology\r\n\r\n          -  Cardiorespiratory pathology or any other severe disease that interferes with the\r\n             functional capacities\r\n\r\n          -  Any decompensated or unstable chronic pathology\r\n\r\n          -  Glomerular filtration rate (GFR)<15 mL/min/1.73m) within the past 6 months\r\n\r\n          -  HBA1c in diabetic people > 12% within the past 6 months\r\n\r\n          -  BMI  35kg/m2\r\n\r\n          -  Infection: joint, general, distant, cutaneous\r\n\r\n          -  Foreign material in the knee to be treated: prosthesis, osteosynthesis material\r\n\r\n          -  Severe coagulation problem: platelets <100000/mm3 within the past 6 months\r\n\r\n          -  Allergy to BoNT-A\r\n\r\n          -  Allergy to HA\r\n\r\n          -  Pregnant or breast-feeding women\r\n\r\n          -  Treatment with aminoglycosides or direct oral anticoagulants\r\n\r\n          -  Treatment with VKA (antihemorrhagic vitamin) if INR (International Normalized Ratio)\r\n             higher than 3 within the past month\r\n\r\n          -  Change of anti-pain treatment less than 2 weeks before enrolment\r\n\r\n          -  Treatment with III pain killers or corticosteroids because of intense pain that does\r\n             not respond to schedule I and II pain-killers\r\n\r\n          -  Intra-articular injection of corticosteroids in the previous two months\r\n\r\n          -  Viscosupplementation and/or injection of BoNT-A in the knee to be treated within the\r\n             past 6 months\r\n\r\n          -  Injection of BoNT-A (except the knee to be treated) within the past 3 months\r\n\r\n          -  Swallowing troubles\r\n      ","sponsor":"University Hospital, Strasbourg, France","sponsor_type":"Other","conditions":"Painful Unilateral Femorotibial Knee Osteoarthritis of Any Etiology","interventions":[{"intervention_type":"Drug","name":"Drug: Botulinum toxin A ( BoNT-A)","description":"Intra-articular injection of BoNT-A"},{"intervention_type":"Device","name":"Device: Hyaluronic acid (HA)","description":"Intra-articular injection of Hyaluronic acid"}],"outcomes":[{"outcome_type":"secondary","measure":"Evaluation of the patients' functional improvement based on the WOMAC score (\"stiffness and function sub-score\" and total score)","time_frame":"Before injection, 1 month, 3 months and 6 months following injection"},{"outcome_type":"secondary","measure":"Evaluation of the patients' functional improvement using the Timed Up-and-go Test","time_frame":"Before injection, 1 month, 3 months and 6 months following injection"},{"outcome_type":"secondary","measure":"Evaluation of the quality of life based on the SF-36 score","time_frame":"Before injection, 1 month, 3 months and 6 months following injection"},{"outcome_type":"secondary","measure":"Frequency, seriousness and severity of adverse event reactions","time_frame":"during the 6 months following injection"},{"outcome_type":"secondary","measure":"Changes in pain treatment score (using a correspondence table)","time_frame":"Change from baseline pain treatment score at 6 months"},{"outcome_type":"primary","measure":"Evaluation of pain measured using the WOMAC pain sub-score","time_frame":"Change from baseline WOMAC pain sub-score at 3 months"},{"outcome_type":"secondary","measure":"Evaluation of the antalgic effect of BoNT-A vs hyaluronic acid measured using a verbal rating scale (VRS)","time_frame":"1 week after injection"},{"outcome_type":"secondary","measure":"Changes in muscular strenght et muscular trophicity (using dynanometer and measure of knee and thin circumference)","time_frame":"Before injection, 1 month, 3 months and 6 months following injection"},{"outcome_type":"secondary","measure":"Changes in passive and active articular knee amplitude, by goniometry","time_frame":"Before injection, 1 month, 3 months and 6 months following injection"}]}
{"nct_id":"NCT03195010","start_date":"2017-06-09","phase":"Phase 2","enrollment":4,"brief_title":"Management of Platelet Transfusion Therapy in Patients With Blood Cancer or Treatment-Induced Thrombocytopenia","official_title":"Management of Venous Thromboembolic Events (VTE) in Patients With Hematologic Disorders and Treatment-Induced Thrombocytopenia: A Pilot Study","primary_completion_date":"2018-12-21","study_type":"Interventional","rec_status":"Terminated","completion_date":"2018-12-21","last_update":"2019-10-21","description":"This pilot clinical trial compares the safety of two different platelet transfusion \"thresholds\" among patients with blood cancer or treatment-induced thrombocytopenia whose condition requires anticoagulant medication (blood thinners) for blood clots. Giving relatively fewer platelet transfusions may reduce the side effects of frequent platelet transfusions without leading to undue bleeding.","other_id":"9799","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Any patient with non-acute promyelocytic leukemia (APL) acute leukemia (acute myeloid\r\n             leukemia [AML], acute lymphoblastic leukemia [ALL], biphenotypic leukemia) undergoing\r\n             curative intent chemotherapy OR any patient undergoing allogeneic hematopoietic stem\r\n             cell transplantation (HSCT) for a hematologic disorder (including acute leukemia as\r\n             above, chronic myelogenous leukemia [CML], chronic lymphocytic leukemia [CLL],\r\n             myelodysplastic syndrome [MDS], primary or secondary myelofibrosis, hypereosinophilic\r\n             syndromes, plasma cell disorders, B-cell or T-cell lymphoma)\r\n\r\n          -  Disease may be measurable or non-measurable\r\n\r\n          -  Diagnosis of symptomatic venous thromboembolism requiring therapeutic-dose\r\n             anticoagulation (unfractionated or low-molecular weight heparin or oral\r\n             anticoagulants) throughout the period of hematopoietic recovery\r\n\r\n          -  Anticipated platelet count =< 50 x 10^9/L for >= 5 days within 72 hours of enrollment\r\n\r\n          -  Ability to understand and the willingness to sign a written informed consent document\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Separate episode of VTE or arterial thrombosis within 3 months of enrollment\r\n\r\n          -  Major bleed (WHO grade 3 or 4) within 6 months of enrollment\r\n\r\n          -  Active bleeding (grade 2 or higher) at the time of enrollment\r\n\r\n          -  History of intracranial bleeding at any time\r\n\r\n          -  Disorders of hemostasis including von Willebrand disease, hemophilia, platelet\r\n             function disorders\r\n\r\n          -  Concomitant use of aspirin or non-steroidal anti-inflammatory drugs\r\n\r\n          -  Evidence of disseminated intravascular anticoagulation (DIC) as determined by the\r\n             patient's primary provider\r\n\r\n          -  History of alloimmunization (defined as platelet refractoriness with panel reactive\r\n             antibody [PRA] > 25%) at the time of or prior to enrollment\r\n\r\n          -  Uncontrolled or concurrent illness including, but not limited to, ongoing or active\r\n             infection, unstable angina pectoris\r\n\r\n          -  Psychiatric illness/social situations that would limit compliance with study\r\n             requirements\r\n\r\n          -  Pregnant or able to become pregnant and unwilling to use two forms of birth control\r\n             during the study period\r\n      ","sponsor":"Fred Hutchinson Cancer Research Center","sponsor_type":"Other","conditions":"Acute Biphenotypic Leukemia|Acute Lymphoblastic Leukemia|Acute Myeloid Leukemia|B-Cell Non-Hodgkin Lymphoma|Chronic Lymphocytic Leukemia|Chronic Myelogenous Leukemia, BCR-ABL1 Positive|Hematologic and Lymphocytic Disorder|Hematopoietic Cell Transplantation Recipient|Myelodysplastic Syndrome|Primary Myelofibrosis|Secondary Myelofibrosis|T-Cell Non-Hodgkin Lymphoma|Thrombocytopenia|Venous Thromboembolism","interventions":[{"intervention_type":"Biological","name":"Biological: Platelet Transfusion","description":"Undergo lower dose platelet transfusion"},{"intervention_type":"Biological","name":"Biological: Platelet Transfusion","description":"Undergo higher dose platelet transfusion"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Eligible Patients Approached for the Study","time_frame":"Up to 1 year"},{"outcome_type":"primary","measure":"Number of Patients Approached for But Refusing Consent","time_frame":"Up to 1 year","description":"Reasons for ineligibility will be reported qualitatively in order to inform future studies."},{"outcome_type":"primary","measure":"Number of Patients Consenting to Enrollment","time_frame":"Up to 1 year"},{"outcome_type":"primary","measure":"Number of Patients Eligible","time_frame":"Up to 1 year"},{"outcome_type":"primary","measure":"Number of Patients Screened and Deemed Ineligible","time_frame":"Up to 1 year","description":"Reasons for ineligibility will be reported qualitatively in order to inform future studies."},{"outcome_type":"primary","measure":"Number of Patients Successfully Following Protocol","time_frame":"Up to 1 year","description":"Will evaluate the number of patients successfully following protocol, defined as receiving transfusions 'on protocol' at the end of the study period."},{"outcome_type":"secondary","measure":"Incidence of Hemorrhagic Events (World Health Organization Grade 2 or Greater)","time_frame":"Up to 1 year","description":"Will evaluate the incidence of hemorrhagic events (World Health Organization grade 2 or greater)."},{"outcome_type":"secondary","measure":"Major Bleeds (World Health Organization Grade 3 or 4)","time_frame":"Up to 1 year","description":"Will evaluate the major bleeds (World Health Organization grade 3 or 4)."},{"outcome_type":"secondary","measure":"Number of Platelet Transfusions Per Patient During the Study Period","time_frame":"Up to 1 year"},{"outcome_type":"secondary","measure":"Percent of Days on Which Subjects Are Transfused (or Transfusion Are Not Given)","time_frame":"Up to 1 year","description":"The frequency with which transfusions are given despite a platelet count above the determined threshold will be documented, as will the frequency with which transfusions are not administered within 24 hours after a platelet count below the determined threshold."},{"outcome_type":"secondary","measure":"Platelet Transfusion Related Complications","time_frame":"Up to 1 year","description":"Total number of transfusion reactions, patients experiencing alloimmunization and volume overload will be reported."},{"outcome_type":"secondary","measure":"Progressive or New Arterial Thromboembolism","time_frame":"Up to 1 year","description":"Will evaluate the progression or new arterial thromboembolism by either documented acute electrocardiographic changes compatible with myocardial injury and/or serum biochemical changes diagnostic of myocardial infarction, or documented imaging (computed tomography or magnetic resonance imaging) changes compatible with infarct due to embolism in the presence of a new neurological deficit, or imaging demonstrated intraluminal filling defects in an arterial distribution accompanied by symptoms of acute ischemia (acute onset pain, pallor, loss of pulses or other end-organ damage)."},{"outcome_type":"secondary","measure":"Progressive or New Venous Thromboembolic","time_frame":"Up to 1 year","description":"Will evaluate the progressive or new venous thromboembolic. Will require imaging confirmation, defined as intraluminal filling defect(s) on contrast-enhanced computed tomography or incompressible venous segment(s) on ultrasonography."}]}
{"nct_id":"NCT03139331","start_date":"2017-06-06","phase":"Phase 1","enrollment":16,"brief_title":"PAZIT Study for Children and Young Adults With Relapsed or Refractory Sarcoma","official_title":"Phase 1 Study of Pazopanib in Combination With Irinotecan and Temozolomide (PAZIT) for Children and Young Adults With Relapsed or Refractory Sarcoma","primary_completion_date":"2019-10-15","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-09-30","last_update":"2021-01-05","description":"This is the first study to evaluate the safety and clinical activity of the combination of oral pazopanib, intravenous or oral irinotecan, and oral temozolomide in pediatric and young adult patients with relapsed or refractory sarcomas. This study will use a 3 + 3 design for dose escalation (Part 1), followed by an expansion cohort (Part 2) at the recommended phase 2 dose level.","other_id":"160821","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":6,"maximum_age":30,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age: Patients must be 6-30 years of age at the time of study enrollment.\r\n\r\n          2. Body Surface Area: Eligible patients have a body surface area >/= 0.7 m2 AND be able\r\n             to swallow whole tablets at the time of study enrollment.\r\n\r\n          3. Diagnosis: Patients must have had histologic verification of one of the malignancies\r\n             listed below at original diagnosis or at time of relapse.\r\n\r\n               -  Ewing sarcoma/peripheral primitive neuroectodermal tumor (PNET)\r\n\r\n               -  Osteosarcoma\r\n\r\n               -  Rhabdomyosarcoma\r\n\r\n               -  Non-rhabdomyosarcoma soft tissue sarcoma\r\n\r\n               -  Desmoplastic small round cell tumor\r\n\r\n             Note: Patients with known involvement of the central nervous system (CNS) by\r\n             malignancy will be included if there is no evidence of active bleeding or intratumoral\r\n             hemorrhage on radiographic imaging.\r\n\r\n          4. Disease Status: Patients must have either measurable or evaluable disease\r\n\r\n          5. Therapeutic Options: Patient's current disease state must be one for which there is\r\n             not known curative therapy or therapy proven to prolong survival with an acceptable\r\n             quality of life.\r\n\r\n          6. Performance Level: Karnofsky >/= 50% for patients > 16 years of age and Lansky >/= 50%\r\n             for patients <\/= 16 years of age.\r\n\r\n             Note: Neurologic deficits in patients with metastatic CNS tumors must have been\r\n             relatively stable for a minimum of 1 week prior to study enrollment. Patients who are\r\n             unable to walk because of paralysis, but who are up in a wheelchair, will be\r\n             considered ambulatory for the purpose of assessing the performance score.\r\n\r\n          7. Prior Therapy: Patients must have fully recovered from the acute toxic effects of all\r\n             prior anti-cancer therapy.\r\n\r\n             Myelosuppressive chemotherapy: Patients must not have received myelosuppressive\r\n             therapy within 2 weeks of enrollment onto this study (6 weeks if prior nitrosourea).\r\n\r\n             Hematopoietic growth factors: At least 14 days after the last dose of a long-acting\r\n             growth factor (e.g. Neulasta) or 7 days for short-acting growth factor. For agents\r\n             that have known adverse events occurring beyond 7 days after administration, this\r\n             period must be extended beyond the time during which adverse events are known to\r\n             occur. The duration of this interval must be discussed with the study chair.\r\n\r\n             Biologic (anti-neoplastic agent): At least 7 days must have passed after the last\r\n             treatment with a biologic agent. For agents that have known adverse events occurring\r\n             beyond 7 days from administration, this period must be extended beyond the time during\r\n             which adverse events are known to occur. The duration of this interval must be\r\n             discussed with the study chair.\r\n\r\n             Immunotherapy: At least 4 weeks since the completion of any type of immunotherapy,\r\n             e.g. tumor vaccines.\r\n\r\n             Monoclonal antibodies: >/= 21 days must have elapsed from infusion of last dose of\r\n             antibody, and toxicity related to prior antibody therapy must be recovered to Grade\r\n             <\/= 1.\r\n\r\n             External beam radiation therapy (XRT): >/= 2 weeks must have elapsed for local\r\n             palliative XRT (small port) and enrollment on study. At least 24 weeks must have\r\n             elapsed since prior Total Body Irradiation (TBI), radiation to 50% of pelvis, or\r\n             craniospinal radiation; >/= 6 weeks must have elapsed if the patient has received\r\n             other substantial bone marrow radiation.\r\n\r\n             Stem Cell Transplant (SCT): No evidence of active graft-versus-host disease (GVHD) and\r\n             >/= 2 months must have elapsed since transplant or rescue.\r\n\r\n             Prior treatment with pazopanib, irinotecan, temozolomide: Patients may not have\r\n             previously received pazopanib. However, patients may have received other vascular\r\n             endothelial growth factor (VEGF) blocking tyrosine kinase inhibitors. Patients must\r\n             have recovered from any VEGF blocking drug-related toxicity (e.g., proteinuria).\r\n\r\n             Patients previously treated with irinotecan and/or temozolomide will be eligible for\r\n             this study provided they did not progress while receiving one of these agents.\r\n\r\n          8. Organ Function Requirements:\r\n\r\n        Adequate Bone Marrow Function defined as:\r\n\r\n          -  Peripheral absolute neutrophil count (ANC) >/= 750/L\r\n\r\n          -  Platelet count >/= 75,000/l (transfusion independent, defined as not receiving\r\n             platelet transfusions within a 7 day period prior to enrollment)\r\n\r\n          -  Hemoglobin >/= 8.0 g/dL; may receive red blood cell (RBC) transfusions\r\n\r\n        Adequate Renal and Metabolic Function defined as:\r\n\r\n          -  Creatinine clearance or radioisotope glomerular filtration rate (GFR) >/= 70\r\n             mL/min/1.73 m2 or\r\n\r\n          -  A serum creatinine based on age/gender per protocol.\r\n\r\n        The threshold creatinine values in this Table were derived from the Schwartz formula for\r\n        estimating GFR utilizing child length and stature data published by the Centers for Disease\r\n        Control and Prevention (CDC).\r\n\r\n          -  Urine protein to creatinine ratio of <1, a urinalysis that is negative for protein, or\r\n             a 24-hour urine protein level <1000 mg/dL\r\n\r\n          -  No more than Grade 1 abnormalities of potassium, calcium (confirmed by ionized\r\n             calcium), magnesium, and phosphorus (supplementation allowed).\r\n\r\n        Adequate Liver Function defined as:\r\n\r\n          -  Total bilirubin <\/= 1.5 x upper limit of normal (ULN) for age\r\n\r\n          -  Serum glutamate pyruvate transaminase (SGPT)/alanine aminotransferase (ALT) <\/= 3.0 x\r\n             ULN (for the purpose of this study, the ULN for SGPT is 45 U/L)\r\n\r\n          -  Serum albumin >/= 2 g/dL\r\n\r\n          -  Must not have active liver or biliary disease (with the exception of Gilbert's\r\n             syndrome or asymptomatic gallstones, liver metastases or otherwise stable chronic\r\n             liver disease per investigator assessment).\r\n\r\n          -  No known positivity of hepatitis B surface antigen (HBsAg), or of positive hepatitis C\r\n             antibody.\r\n\r\n        Adequate Cardiac Function defined as:\r\n\r\n          -  Shortening fraction of >/= 27% by echocardiogram (while not receiving medications for\r\n             cardiac function), or\r\n\r\n          -  Ejection fraction of >/= 50% by gated radionuclide study (while not receiving\r\n             medications for cardiac function).\r\n\r\n          -  Corrected QT interval (QTc) < 480 msec\r\n\r\n          -  Must not have a history of myocardial infarction, severe or unstable angina,\r\n             peripheral vascular disease or familial QT prolongation.\r\n\r\n        Adequate Blood Pressure Control defined as: A blood pressure (BP) <\/= 95% percentile for\r\n        age, height, and gender. Patients on stable doses of no more than one anti-hypertensive\r\n        medication, with a baseline BP <\/= 95% percentile for age, height, and gender will be\r\n        eligible.\r\n\r\n        Central Nervous System Function defined as:\r\n\r\n          -  Patients with a known history of seizures must have well-controlled seizures and may\r\n             not be receiving enzyme-inducing anti-convulsants\r\n\r\n          -  CNS toxicity <\/= Grade 2.\r\n\r\n        Adequate pulmonary function defined as:\r\n\r\n          -  No evidence of dyspnea at rest\r\n\r\n          -  No exercise intolerance\r\n\r\n        Adequate Coagulation defined as: prothrombin time (PT) and partial thromboplastin time\r\n        (PTT) <\/= 1.5 x ULN and an international normalized ratio (INR) <\/= 1.2.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Pregnancy or Breast-Feeding: Pregnant or breastfeeding women will not be entered on\r\n             this study due to risks of fetal and teratogenic adverse events as seen in\r\n             animal/human studies. Negative pregnancy tests must be obtained in girls who are\r\n             post-menarchal. Males or females of reproductive potential may not participate unless\r\n             they have agreed to use an effective contraceptive method. The definition of adequate\r\n             contraception will be based on the judgment of the principal investigator or\r\n             designated associate. Study drug may also potentially be secreted in milk and\r\n             therefore breastfeeding women are excluded.\r\n\r\n          2. Concomitant Medications:\r\n\r\n             Corticosteroids: Patients requiring corticosteroids who have not been on a stable or\r\n             decreasing dose of corticosteroid for the 7 days prior to enrollment are not eligible.\r\n\r\n             Investigational Drugs: patients who are currently receiving another investigational\r\n             drug are not eligible.\r\n\r\n             Anti-cancer Agents or Radiation Therapy: Patients who are currently receiving other\r\n             anti-cancer agents or radiation therapy are not eligible.\r\n\r\n             Anti-hypertensive Medications: Patients who are currently receiving more than one\r\n             anti-hypertensive medication or whose blood pressure is not controlled as defined by\r\n             protocol are not eligible for study enrollment.\r\n\r\n             Anti-coagulation: Patients must not be on therapeutic anti-coagulation. Prophylactic\r\n             anti-coagulation (i.e., intraluminal heparin) of venous or arterial access devices is\r\n             allowed.\r\n\r\n             Anti-inflammatory and Anti-platelet Agents: Patients currently receiving aspirin,\r\n             and/or ibuprofen, or other NSAIDs are not eligible.\r\n\r\n             Enzyme-inducing Anti-convulsants: Patients who are currently receiving enzyme-inducing\r\n             anti-convulsants are not eligible.\r\n\r\n             CYP3A4 Substrates and Drugs Causing QTc Prolongation: Patients receiving drugs with a\r\n             known risk of torsades de pointes are not eligible. A list of enzyme inducing, enzyme\r\n             inhibiting, and other prohibited drugs is provided by the protocol.\r\n\r\n             Note: This list includes the prohibition of grapefruit for 14 days prior to\r\n             enrollment.\r\n\r\n             Thyroid Replacement Therapy: Patients who require thyroid replacement therapy are not\r\n             eligible if they have not been receiving a stable replacement dose for at least 4\r\n             weeks prior to study enrollment.\r\n\r\n          3. Patients who are unable to swallow whole tablets are not eligible.\r\n\r\n          4. Infection: Patients who have an active or uncontrolled infection are not eligible.\r\n\r\n          5. Bleeding and Thrombosis: Patients will be excluded if any of the following are\r\n             present:\r\n\r\n               -  Evidence of active bleeding, intratumoral hemorrhage, or bleeding diathesis.\r\n\r\n               -  History (within 6 months prior to study enrollment) of pulmonary embolism, deep\r\n                  vein thrombosis (DVT), or other venous thromboembolic event.\r\n\r\n               -  History of hemoptysis within 6 weeks prior to study enrollment.\r\n\r\n          6. Patients with known involvement of the CNS by malignancy will be included if there is\r\n             no evidence of active bleeding or intratumoral hemorrhage on radiographic imaging.\r\n\r\n          7. Surgery: Patients who have had or are planning to have the following invasive\r\n             procedures will be excluded:\r\n\r\n               -  Major surgical procedures, laparoscopic procedure, open biopsy, or significant\r\n                  traumatic injury within 28 days prior to Day 1 therapy. Subcutaneous port\r\n                  placement or central line placement is not considered major surgery, but must be\r\n                  placed greater than 48 hours from planned Day 1 of therapy.\r\n\r\n               -  Core biopsy within 7 days prior to Day 1 therapy.\r\n\r\n               -  Fine needle aspirate or central line placement within 48 hours prior to Day 1\r\n                  therapy.\r\n\r\n             Note: Routine bone marrow aspirate and biopsy for the purposes of disease staging are\r\n             not part of these exclusion guidelines.\r\n\r\n          8. Patients with serious or non-healing wound, ulcer, or bone fracture.\r\n\r\n          9. History of abdominal fistula, gastrointestinal perforation, pneumothorax, or\r\n             intra-abdominal abscess within 28 days of study enrollment.\r\n\r\n         10. Patients who in the opinion of the investigator may not be able to comply with the\r\n             safety monitoring requirements of the study are not eligible.\r\n\r\n         11. Patients with history of allergic reactions attributed to compounds of similar\r\n             composition to pazopanib, irinotecan, or temozolomide are not eligible.\r\n      ","sponsor":"University of California, San Francisco","sponsor_type":"Other","conditions":"Sarcoma|Refractory Sarcoma","interventions":[{"intervention_type":"Drug","name":"Drug: Pazopanib","description":"Pazopanib will be administered orally as a tablet according to an assigned dose level per protocol. A cycle will be defined as 21 days. Drug dosing for the tablet formulation will be determined using a study-specific nomogram."},{"intervention_type":"Drug","name":"Drug: Irinotecan","description":"Patients will be given irinotecan at a dose of 25 mg/m2/dose IV on days 1-5 of a 21-day cycle during Cycle 1. In subsequent cycles, irinotecan may be given intravenously at a dose of 25 to 37.5 mg/m2/dose or orally at a dose of 45 to 67.5 mg/m2/dose on days 1-5 of a 21-day cycle.\r\nNote that some patients enrolled on an earlier protocol version received 50 mg/m2/dose IV on days 1-5 of the first 21-day cycle and then either 50 mg/m2/dose IV or 90 mg/m2/dose orally for subsequent 21-day cycles. This higher dose level is no longer being given to newly enrolled subjects."},{"intervention_type":"Drug","name":"Drug: Temozolomide","description":"Temozolomide will be given at a dose of 100 mg/m2/dose orally on days 1-5 of each 21-day cycle."}],"outcomes":[{"outcome_type":"primary","measure":"Maximum Tolerated Dose","time_frame":"3 weeks","description":"Maximum tolerated dose or recommended phase 2 dose of pazopanib administered in combination with irinotecan and temozolomide"},{"outcome_type":"primary","measure":"Number of Patients with Dose-Limiting Toxicities (DLTs) Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0","time_frame":"3 weeks","description":"Toxicity will be graded using the CTCAE criteria, version 4.0. DLT will be defined as any of the events as defined per the protocol that are at least possibly, probably, or definitely attributable to the combination of pazopanib, irinotecan, and temozolomide. DLTs are generally grade 3 or greater in severity.\r\nDose limiting hematological and non-hematological toxicities are defined differently, per the protocol."},{"outcome_type":"primary","measure":"Describing toxicities of PAZIT drug combination using NCI CTCAE Version 4.0","time_frame":"3 weeks","description":"To describe any toxicities associated with the combination of pazopanib, irinotecan and temozolomide (PAZIT)."},{"outcome_type":"secondary","measure":"Objective Response Rate Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1","time_frame":"From treatment initiation until disease progression, an average of about 6 months","description":"The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. Tumor response will be assessed using RECIST version 1.1."},{"outcome_type":"secondary","measure":"Progression-Free Survival (PFS) Using RECIST Version 1.1","time_frame":"From treatment initiation until disease progression, an average of about 6 months","description":"PFS is defined as the duration of time from start of treatment to time of tumor progression. Tumor response will be assessed using RECIST version 1.1."},{"outcome_type":"secondary","measure":"Overall Survival (OS)","time_frame":"From treatment initiation until death, an average of about 1 year","description":"OS is defined as the duration of time from start of treatment to time of death from any cause."}]}
{"nct_id":"NCT03155750","start_date":"2017-06-05","phase":"N/A","enrollment":37,"brief_title":"Effects of Zero-Time Exercise (ZTEx) on Inactive Adults With Insomnia","official_title":"Effects of Zero-Time Exercise (ZTEx) on Inactive Adults With Insomnia: A Pilot Randomized Controlled Trial","primary_completion_date":"2017-09-07","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-09-07","last_update":"2017-10-20","description":"Objectives: To evaluate the clinical effects of Zero-Time Exercise (ZTEx) for treating insomnia disorder delivered by a training course. Hypothesis: Subjects in the ZTEx training group will have greater improvement in insomnia symptoms and daytime impairment than those in the sleep hygiene education (SHE) group at week 8. Design and subjects: A randomized controlled trial. 32 inactive subjects with insomnia disorder recruited from the community will be randomized to ZTEx training or SHE groups in a 1: 1 ratio. Study instrument: Insomnia Severity Index (ISI) will be used to assess insomnia symptoms and daytime impairment. Interventions: Subjects in the ZTEx training group will attend two training lessons (2-hour each) to learn ZTEx and practice it every night for 8 weeks; subjects in the SHE group will receive sleep hygiene education with the schedule and duration that are same to the ZTEx training group. Main outcome measures: The primary outcome measure is the ISI score. Other measures include sleep parameters by subjective sleep diary and objective actigraphy, Hospital Anxiety and Depression Scale, Multidimensional Fatigue Inventory-20 and Short Form-6 Dimension. Acceptability and compliance of ZTEx will be evaluated. Data Analysis: Differences in the questionnaire scores, subjective and objective sleep parameters will be examined using a mixed-effects model.","other_id":"ZTEInsomnia","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adults age 18-65 years old;\r\n\r\n          -  Chinese Hong Kong residents who are able to communicate in Cantonese or Mandarin;\r\n\r\n          -  A current clinical Diagnostic and Statistical Manual of Mental Disorders-fifth edition\r\n             (DSM-5) diagnosis of insomnia disorder (Primary in nature) according to the Brief\r\n             Insomnia Questionnaire (BIQ), a validated diagnostic tool. The criteria include having\r\n             difficulties in falling asleep, difficulties in staying asleep, or early morning\r\n             awakening with clinically significant consequences for daily life for at least 3\r\n             months;\r\n\r\n          -  Insomnia Severity Index total score of at least 10 indicating insomnia at the clinical\r\n             level;\r\n\r\n          -  Willing to give informed consent and comply with the trial protocol;\r\n\r\n          -  Ambulant and independent in activities of daily living;\r\n\r\n          -  Physically inactive which refers to less than 150 minutes moderate-intensity activity\r\n             per week or less than 75 minutes vigorous-intensity activity per week, or an\r\n             equivalent combination of moderate- and vigorous- intensity activity.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Evidence of association of insomnia with medical conditions, other sleep disorders, or\r\n             side-effects of medications;\r\n\r\n          -  Use of medication or psychotherapeutic components for insomnia or other psychiatric\r\n             disorders;\r\n\r\n          -  Other possible psychiatric disorders including generalized anxiety disorder (GAD),\r\n             major depressive disorder (MDD), posttraumatic stress disorder (PTSD), psychosis as\r\n             screened by structural clinical interview of DSM-IV;\r\n\r\n          -  cognitive impairment preventing informed consent or understanding of instructions\r\n             (score < 22 in Montreal Cognitive Assessment Hong Kong version);\r\n\r\n          -  Shift work;\r\n\r\n          -  body mass index equal to or over 27.5, the obese criteria for Asians;\r\n\r\n          -  Unsafe conditions or incapable to exercise as recommended by their physician.\r\n      ","sponsor":"The Hong Kong Polytechnic University","sponsor_type":"Other","conditions":"Insomnia, Primary","interventions":[{"intervention_type":"Other","name":"Other: Zero Time Exercise","description":"Zero Time Exercise encourage people to increase physical exercise by simple movements that can be done any time at any places. We offer a 2-session training course to train the subjects to do zero-time exercise."},{"intervention_type":"Other","name":"Other: Sleep hygiene education","description":"We offer a 2-session education course to teach the subjects about sleep hygiene practice."}],"outcomes":[{"outcome_type":"primary","measure":"Insomnia Severity Index","time_frame":"week 8","description":"The subjects rate the severity of insomnia, the distress, and the functional impairment associated with insomnia on a 5-point"},{"outcome_type":"secondary","measure":"Sleep diary (7-day)","time_frame":"Baseline, week 4, week 8","description":"The standardized sleep diary records the daily bedtime and rising time, from which the total time in bed (TIB) can be calculated."},{"outcome_type":"secondary","measure":"Multidimensional fatigue inventory-20","time_frame":"Baseline, week 4, week 8","description":"Multidimensional fatigue inventory-20 is a 20-items self-report instrument designed to measure severity of fatigue."},{"outcome_type":"secondary","measure":"Hospital Anxiety and Depression Scale","time_frame":"Baseline, week 4, week 8","description":"The Hospital Anxiety and Depression Scale is a 14-items self-administered questionnaire, which assesses the severity of depressive and anxiety symptoms"},{"outcome_type":"secondary","measure":"Actigraphy (7-day)","time_frame":"Baseline, week 8","description":"Actigraphy measures wrist movements to assess sleep or waking state, is accomplished through an accelerometer in a wrist worn device"},{"outcome_type":"secondary","measure":"Short Form-6 Dimension","time_frame":"Baseline, week 4, week 8","description":"The Short Form-6 Dimension is composed of six multi-level dimensions to assess the quality of life which can be used in cost-utility analysis."},{"outcome_type":"secondary","measure":"Hand grip strength","time_frame":"Baseline, week 8","description":"Objective hand grip strength"},{"outcome_type":"secondary","measure":"Level of activity","time_frame":"Baseline, week4, week 8","description":"Self-report level of activity in moderate and vigorous intensity"},{"outcome_type":"secondary","measure":"Weight","time_frame":"Baseline, week 8","description":"Weight in kilograms; (Weight and Height will be combined to report as BMI in kg/m^2)"},{"outcome_type":"secondary","measure":"Height","time_frame":"Baseline, week 8","description":"Height in meters; (Weight and Height will be combined to report as BMI in kg/m^2)"}]}
{"nct_id":"NCT03506750","start_date":"2017-06-03","phase":"Phase 4","enrollment":200,"brief_title":"Day Regimes of CONbercept on CytokinEs of PDR Patients Undergoing Vitrectomy - Trial (CONCEPT)","official_title":"Different Day Regimes of Preoperative CONbercept Administration on CytokinEs of Proliferative Diabetic Retinopathy Patients Undergoing Vitrectomy: a Prospective Randomized Controlled Clinical Trial (CONCEPT)","primary_completion_date":"2018-09-01","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2018-12-31","last_update":"2018-04-24","description":"Patients with proliferative diabetic retinopathy requiring surgical intervention will receive a pre-operative injection of Conbercept. Patients will be recruited into different groups according to variable time intervals (1 to 7 days) between intravitreous injection and surgery. At initial, pre-injection aqueous humor and blood sample will be collected in order to provide baseline VEGF-A, -B, placental growth factor (PIGF), and other cytokine levels. At the onset of the vitrectomy, a second aqueous humor, blood, and vitreous sample will be taken to obtain intra-operative levels of , VEGF-A, -B, PIGF, and other cytokine levels.","other_id":"CONCEPT","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18 years or older\r\n\r\n          -  Type 1 or 2 diabetes\r\n\r\n          -  PDR patients requiring surgical intervention for complications of vitreous hemorrhage\r\n             or traction retinal detachment and pre-operative IVC treatment.\r\n\r\n          -  women postmenopausal for 12 months before the study, surgically sterile, or not\r\n             pregnant and on effective contraception.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  previous retinal vein occlusion.\r\n\r\n          -  any intraocular surgery within the previous 12 months.\r\n\r\n          -  myopia of > or = to 8 diopters.\r\n\r\n          -  active ocular or periocular infection\r\n\r\n          -  treatment with an investigational agent for any condition 60 days prior to enrollment.\r\n\r\n          -  evidence of severe cardiac disease.\r\n\r\n          -  clinically significant peripheral vascular disease (previous surgery, amputation, or\r\n             symptoms of claudication)\r\n\r\n          -  uncontrolled hypertension (treated systolic blood pressure > 155 mmHg or diastolic\r\n             blood pressure > 95 mmHg)\r\n\r\n          -  stroke within the preceding 12 months.\r\n      ","sponsor":"The First Affiliated Hospital with Nanjing Medical University","sponsor_type":"Other","conditions":"Proliferative Diabetic Retinopathy|VEGF Overexpression","interventions":[{"intervention_type":"Drug","name":"Drug: IVC","description":"Patients with PDR will receive intravitreal injection of conbercept (0.5 mg/0.05 mL; Chengdu Kanghong Biotech, Inc., Chengdu, Sichuan, China) in the inferior-temporal sector 4 mm from the sclerocorneal limbus before pars plana vitrectomy (PPV) surgery."},{"intervention_type":"Procedure","name":"Procedure: Blood and aqueous humor at the time of IVC","description":"Initial blood and aqueous humor will be harvested at the time of IVC."},{"intervention_type":"Procedure","name":"Procedure: Collect blood, aqueous humor, and initial vitreous at the time of surgery.","description":"Blood, aqueous humor, and vitreous will be collected at the time of surgery."},{"intervention_type":"Procedure","name":"Procedure: IVC-sham","description":"Patients with PDR will receive sham intravitreal injection of conbercept in the inferior-temporal sector 4 mm from the sclerocorneal limbus 4 days before PPV surgery."}],"outcomes":[{"outcome_type":"primary","measure":"Changes of intraocular VEGF and PLGF of patients with proliferative diabetic retinopathy post-IVC (intravitreous injection of Conbercept).","time_frame":"1-7 days"},{"outcome_type":"secondary","measure":"Changes of serum angiogenesis-related pro-cytokines in patients with proliferative diabetic retinopathy","time_frame":"1-7 days"},{"outcome_type":"secondary","measure":"Changes of intraocular and serum profibrotic cytokines in patients with proliferative diabetic retinopathy post-IVC.","time_frame":"1-7 days"},{"outcome_type":"secondary","measure":"Changes of intraocular and serum inflammatory cytokines in patients with proliferative diabetic retinopathy post-IVC.","time_frame":"1-7 days"},{"outcome_type":"secondary","measure":"Vitreous concentration of Conbercept","time_frame":"1-7 days","description":"Detection of Vitreous concentration of the drug of Conbercept (Conbercept is a kind of fusion protein)"},{"outcome_type":"secondary","measure":"Effect of IVC on surgery time of surgery","time_frame":"Surgery day","description":"surgery time of vitrectomy"},{"outcome_type":"secondary","measure":"Effect of IVC on intraoperative complication of surgery","time_frame":"Surgery day","description":"Record the intraoperative complication: bleeding and iatrogenic retinal hole when surgically removing the proliferative membranes."},{"outcome_type":"secondary","measure":"Effect of IVC on regression of neovascularization on vitreous fibrovascular membrane with optic coherence tomography angiography (OCTA)","time_frame":"1 to 7 days","description":"OCTA monitor the changes of neovascularization on vitreous fibrovascular membrane after IVC and before surgery"},{"outcome_type":"secondary","measure":"Effect of IVC on postoperative visual acuity","time_frame":"1 to12 months","description":"Best-corrected visual acuity postoperatively"},{"outcome_type":"secondary","measure":"Effect of IVC on postoperative complications","time_frame":"1 to12 months","description":"Record number of patient with vitreous re-bleeding and iris neovascularization postoperatively."}]}
{"nct_id":"NCT03713723","start_date":"2017-06-01","enrollment":50,"brief_title":"Cardiac Output Monitoring in IVF Patients","official_title":"Cardiac Output Monitoring in Patients Undergoing In Vitro Fertilization by Noninvasive Cardiac Impendence: A Prospective Observational Study","primary_completion_date":"2020-12-01","study_type":"Observational","rec_status":"Unknown status","completion_date":"2020-12-31","last_update":"2019-09-24","description":"In this study we aim to evaluate hemodynamic effects of IVF treatment, with the use of the non invasive NICaS bioimpendence monitor. Our study's primary end point is to evaluate the hemodynamic profile with the use of NICaS whole body impedance cardiography that occur throughout the IVF cycle in patients undergoing controlled ovarian stimulation during IVF treatment. Secondary endpoints include: Women will be asked to grade their pain score and level of anxiety by the use of the visual analogue score elicited throughout the study observation points, in order to examine whether pain scores and anxiety levels correlate with the hemodynamic changes throughout an IVF treatment cycle.","other_id":"172-17","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"Female","minimum_age":18,"maximum_age":45,"population":"This is a prospective, observational, single center study which will be conducted at the\r\n        Rabin Medical Center (Beilinson Campus), Petach Tikva, Israel, a tertiary university\r\n        hospital. Fifty healthy woman (45 years old) undergoing IVF treatment will be enrolled\r\n        following filling out an informed consent form.","criteria":"\n        Inclusion Criteria:\r\n\r\n        Women above 18-45 undergoing their first, second or third cycle of IVF treatment in\r\n        Beilinson Hospital following obtaining written informed consents forums with the ability to\r\n        comply with the study requirements will be included in our study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Women under age 18\r\n\r\n          -  Women with polycystic ovarian syndrome\r\n\r\n          -  Women with cardiomyopathy\r\n\r\n          -  Women with history of chronic hypertension\r\n\r\n          -  Women with a congenital heart disease\r\n\r\n          -  Women who are not able to comply with study requirements and can't sign an informed\r\n             consent forum.\r\n      ","sponsor":"Rabin Medical Center","sponsor_type":"Other","conditions":"Fertilization in Vitro","interventions":[{"intervention_type":"Device","name":"Device: NICaS bioimpedance system","description":"NICaS is a bioimpedance system focusing on noninvasive assessment and monitoring of cardiovascular, respiratory, and fluid parameters.Cardiovascular monitoring will be carried out using non-invasive NICAS cardiac impedance cardiography by the use of two electrodes stickers which are pasted on the wrists for 6 minutes"}],"outcomes":[{"outcome_type":"primary","measure":"Cardiac output measurement with the use of non-invasive NICAS hemodynamic monitor","time_frame":"On the day of ovum pickup prior to their entrance to the operating theater."},{"outcome_type":"secondary","measure":"Cardiac output measurement with the use of non-invasive NICAS hemodynamic monitor","time_frame":"1-3rd day of the menstrual cycle prior to treatment with gonadotropins"}]}
{"nct_id":"NCT03528850","start_date":"2017-06-01","phase":"N/A","enrollment":180,"brief_title":"Stony Brook Telehealth Study","official_title":"Stony Brook Telehealth Study. Tele-transitions of Care. An Approach to Reduce 30-day Readmission Using Tele-Health Technology; A Randomized Controlled Trial","primary_completion_date":"2018-05-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2018-05-30","last_update":"2018-05-18","description":"The study evaluates the feasibility of providing tele-transition of care, using risk stratification, novel data tools, remote patient monitoring and virtual visits. A new communication tool for relaying tele-communication among providers caring for the virtual patient is introduced. The primary endpoint is 30-day readmissions.","other_id":"970227","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":30,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Family Medicine Patients who are:\r\n\r\n               -  Age 30 years or older\r\n\r\n               -  Able to provide consent for their own care\r\n\r\n               -  English speakers (able to comprehend and speak English)\r\n\r\n               -  Patients with good cognitive function (as evidence by ability to answer a mild\r\n                  cognitive screen (age, telephone, current date, name of facility)\r\n\r\n               -  Living within reasonable commute to the Family Medical Group clinics\r\n\r\n               -  Patients with a life expectancy greater than 6 months\r\n\r\n               -  Patients with a clinical disposition to home after hospital discharge\r\n\r\n               -  Patients that are able to turn on the telehealth technology and follow prompts\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Uninsured patients who are not currently seen by the Family Medicine Practice\r\n\r\n          -  Patients whose physical limitations prohibit the use of the telehealth equipment\r\n\r\n          -  Patients involved in another research study\r\n\r\n          -  Pregnant patients (patients actively trying to conceive)\r\n\r\n          -  Admission for a psychiatric primary diagnosis\r\n      ","sponsor":"Stony Brook University","sponsor_type":"Other","conditions":"Telemedicine|Patient Readmission","interventions":[{"intervention_type":"Other","name":"Other: Telemedicine evaluation","description":"Weekly virtual visits and daily biometric readings of blood pressure, weight, oxygen saturation and pulse"}],"outcomes":[{"outcome_type":"primary","measure":"Hospital Readmission","time_frame":"30 Days","description":"Hospital Readmission is calculated by data abstracted from the Electronic Medical Record and by surveys. Study data is collected and managed using REDCap (16) electronic data capture tools hosted at Stony Brook Medicine. REDCap (Research Electronic Data Capture) is a secure, web-based application designed to support data capture for research studies, providing: 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for importing data from external sources. REDCap software allows the team to incorporate a randomization schema to include it in the process of enrollment seamlessly. After meeting inclusion criteria, the software follows a schema unknown to the researchers to randomly select consented participants into appropriate arms of trial."},{"outcome_type":"secondary","measure":"Emergency Room Utilization","time_frame":"30 Days","description":"Emergency Room Utilization is calculated by data abstracted from the Electronic Medical Record and by surveys. Study data is collected and managed using REDCap (16) electronic data capture tools hosted at Stony Brook Medicine. REDCap (Research Electronic Data Capture) is a secure, web-based application designed to support data capture for research studies, providing: 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for importing data from external sources. REDCap software allows the team to incorporate a randomization schema to include it in the process of enrollment seamlessly. After meeting inclusion criteria, the software follows a schema unknown to the researchers to randomly select consented participants into appropriate arms of trial."}]}
{"nct_id":"NCT03436472","start_date":"2017-06-01","phase":"N/A","enrollment":700,"brief_title":"Dexmedetomidine and 5-year Outcome in Elderly Patients After Surgery","official_title":"Impact of Dexmedetomidine on Long-term Outcome in Elderly Patients After Noncardiac Surgery: 5-year Follow-up of a Randomized Controlled Trial","primary_completion_date":"2019-01-08","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-04-01","last_update":"2019-06-21","description":"Delirium is a frequent postoperative complication. Its occurrence is associated with worse long-term outcomes. In a previous randomized controlled trial, prophylactic low-dose dexmedetomidine infusion during the early postoperative period decreased the incidence of delirium in elderly patients after surgery. The purpose of this 5-year follow-up study is to evaluate whether prophylactic low-dose dexmedetomidine infusion can improve the 5-year outcomes in elderly patients recruited in the previous randomized controlled trial.","other_id":"Dex-5-2016","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Quadruple","intervention_model_description":"Parallel Assignment","sampling_method":"","gender":"All","minimum_age":65,"maximum_age":90,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Patients were included if they met all of the following criteria:\r\n\r\n          -  Age of 65 years or older;\r\n\r\n          -  Underwent elective noncardiac surgery under general anesthesia;\r\n\r\n          -  Admitted to ICU after surgery.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Patients were excluded if they met any of the following criteria:\r\n\r\n          -  Preoperative history of schizophrenia, epilepsy, Parkinsonism or myasthenia gravis;\r\n\r\n          -  Inability to communicate in the preoperative period (because of coma, profound\r\n             dementia or language barrier);\r\n\r\n          -  Brain injury or neurosurgery;\r\n\r\n          -  Preoperative left ventricular ejection fraction < 30%, sick sinus syndrome, severe\r\n             sinus bradycardia (< 50 beats per minute), or second-degree or greater\r\n             atrioventricular block without pacemaker;\r\n\r\n          -  Serious hepatic dysfunction (Child-Pugh class C);\r\n\r\n          -  Serious renal dysfunction (undergoing dialysis before surgery); or\r\n\r\n          -  Unlikely to survive for more than 24 hours.\r\n      ","sponsor":"Peking University First Hospital","sponsor_type":"Other","conditions":"Aged|Operative|Delirium|Dexmedetomidine|Mortality|Long-term Survivors","interventions":[{"intervention_type":"Drug","name":"Drug: dexmedetomidine","description":"low-dose dexmedetomidine infusion"},{"intervention_type":"Drug","name":"Drug: placebo","description":"normal saline infusion"}],"outcomes":[{"outcome_type":"other","measure":"Cognitive function in the subgroup of 5-year survivors after cancer or non-cancer surgery","time_frame":"At the end of the 5th year after surgery","description":"Cognitive function is assessed with Telephone Interview for Cognitive Status-Modified (TICS-M)"},{"outcome_type":"primary","measure":"Duration of 5-year survival after surgery","time_frame":"From the day of surgery until the end of the 5th year after surgery","description":"Duration of 5-year survival after surgery"},{"outcome_type":"secondary","measure":"Survival rates after surgery","time_frame":"At 6 months, 1 year, 2 years ,3 years, 4 years,and 5 years after surgery","description":"Survival rates at different timepoints after surgery"},{"outcome_type":"secondary","measure":"Cognitive function in 5-year survivors after surgery","time_frame":"At the end of the 5th year after surgery","description":"Cognitive function is assessed with Telephone Interview for Cognitive Status-Modified (TICS-M)."},{"outcome_type":"secondary","measure":"Health related quality of life in 5-year survivors after surgery","time_frame":"At the end of the 5th year after surgery","description":"Health related quality of life is assessed with World Health Organization Quality of Life-BREF (WHOQOL-BREF)."},{"outcome_type":"other","measure":"Survival rates in the subgroup of patients after cancer or non-cancer surgery","time_frame":"At 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years after surgery","description":"Survival rates at different time-points in the subgroup of patients after cancer or non-cancer surgery"},{"outcome_type":"other","measure":"Duration of survival in the subgroup of patients after cancer or non-cancer surgery","time_frame":"From the day of surgery until the end of the 5th year after surgery","description":"Duration of survival in the subgroup of patients after cancer or non-cancer surgery"},{"outcome_type":"other","measure":"Health related quality of life in the subgroup of 5-year survivors after cancer or non-cancer surgery","time_frame":"At the end of the 5th year after surgery","description":"Health related quality of life is assessed with World Health Organization Quality of Life-BREF (WHOQOL-BREF)."}]}
{"nct_id":"NCT04921202","start_date":"2017-06-01","enrollment":180,"brief_title":"Metabolic Syndrome and Degenerative Meniscus Lesions Related Knee Function","official_title":"First Affiliated Hospital of Jinzhou Medical Universtiy","primary_completion_date":"2020-03-25","study_type":"Observational","rec_status":"Completed","completion_date":"2021-03-01","last_update":"2021-06-10","description":"Studies have suggested that Obese patients with metabolic syndrome(MetS)were correlated with knee joint degeneration and osteoarthritis. However, no studies demonstrate the relationship between obese patients with metabolic syndrome and degenerate meniscus lesions and its knee function.The aim is to detect the correlation between obese patients with metabolic syndrome and degenerate meniscus injuries.","other_id":"Jinzhou Medical University","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":35,"maximum_age":70,"population":"participants from Jinzhou City, west of Liaoning Province","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Must be age between 35 and 70 years old;\r\n\r\n          -  Clinical diagnosis of metabolic syndrome;\r\n\r\n          -  BMI score more than 27 or less than 24\r\n\r\n          -  Clinical diagnosis of 3 grade degneration meniscus leisons;\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Must be able to have no acute knee injury such as car crash or acute sports injury;\r\n\r\n          -  Must be able to have no knee surgeries history;\r\n\r\n          -  Must be able to have no rheumatoid arthritis or serious knee osteoarthritis with\r\n             deformity;\r\n\r\n          -  Must be able to have no contraindications to MRI;\r\n\r\n          -  Must be able to have no severe cardiopulmonary disease;\r\n\r\n          -  Must be able to have no musculoskeletal or neuromuscular impairments ;\r\n\r\n          -  Must be able to have good visual, hearing, or cognitive;\r\n      ","sponsor":"The First People's Hospital of Jingzhou","sponsor_type":"Other","conditions":"Metabolic Syndrome|Meniscus Lesion|Obesity, Abdominal|Knee Arthritis","interventions":[{"intervention_type":"Other","name":"Other: Metabolic syndrome and meniscus injuries","description":"Metabolic syndrome"}],"outcomes":[{"outcome_type":"secondary","measure":"knee-related Quality of Life subscale","time_frame":"up to 12 month","description":"knee-related Quality of Life including 4 items,The minimum value is 0 and maximum values subscale is 100. Each subscale is scored separately from zero (extreme knee problems) to 100 (no knee problems)."},{"outcome_type":"primary","measure":"the Knee injury and Osteoarthritis Outcome Score (KOOS) total","time_frame":"up to 12 month","description":"The Knee injury and Osteoarthritis Outcome Score (KOOS) holds five subscales including: Pain (9 items); other Symptoms (7 items); Activities of Daily Living (ADL, 17 items); Sport and Recreation function (Sport/Rec, 5 items); and knee-related Quality of Life (QoL, 4 items). Each subscale is scored separately from zero (extreme knee problems) to 100 (no knee problems)."},{"outcome_type":"primary","measure":"The International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC) score","time_frame":"up to 12 month","description":"The International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC) score to determine the meniscus function. The IKDC is a questionnaire that has high reliability and validity for patients with a meniscal tear[36, 37] [38]. The questionnaire contains 18 items (7 items for symptoms, 1 item for sport activity, 9 items for daily activities, and 1 item for current knee function.) The total score is transformed to a value on a scale of 0 to 100, with 100 representing the highest knee function and 0 is the worst."},{"outcome_type":"secondary","measure":"KOOS Pain subscale","time_frame":"up to 12 month","description":"Pain including 9 items，The minimum value is 0 and maximum values subscale is 100, the scored separately from zero (extreme knee problems) to 100 (no knee problems)"},{"outcome_type":"secondary","measure":"Symptoms subscale","time_frame":"up to 12 month","description":"Symptoms including 7 items,The minimum value is 0 and maximum values subscale is 100. Each subscale is scored separately from zero (extreme knee problems) to 100 (no knee problems)"},{"outcome_type":"secondary","measure":"Activities of Daily Living subscale","time_frame":"up to 12 month","description":"Activities of Daily Living including 17 items,The minimum value is 0 and maximum values subscale is100. Each subscale is scored separately from zero (extreme knee problems) to 100 (no knee problems)."},{"outcome_type":"secondary","measure":"Sport and Recreation function subscale","time_frame":"up to 12 month","description":"Sport and Recreation function including 5 items,The minimum value is 0 and maximum values subscale is 100. Each subscale is scored separately from zero (extreme knee problems) to 100 (no knee problems)."},{"outcome_type":"secondary","measure":"KOOS4","time_frame":"up to 12 month","description":"KOOS4, The minimum value is 0 and maximum values subscale is100. KOOS4 defined as the average score for four of the five knee injury and osteoarthritis outcome score (KOOS) validity for patients with meniscal tears and osteoarthritis."}]}
{"nct_id":"NCT03155191","start_date":"2017-06-01","phase":"Phase 1/Phase 2","enrollment":21,"brief_title":"Study of TBI-1501 for Relapsed or Refractory Acute Lymphoblastic Leukemia","official_title":"A Multicenter Phase I/II Study for Relapsed or Refractory CD19+ B-acute Lymphoblastic Leukemia","primary_completion_date":"2035-03-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2035-03-31","last_update":"2020-12-28","description":"Evaluate the safety (P-I), pharmacokinetics and anti-tumor effect of immunotherapy of autologous T cells genetically modified to express anti-CD19 chimeric antigen receptor (CAR) (TBI-1501) for relapsed or refractory CD19+ B-cell acute lymphoblastic leukemia.","other_id":"1501-01","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Peripheral blood will be collected from a subject after obtaining a written informed consent. Peripheral blood mononuclear cells (PBMCs) and plasma are obtained from the blood, and T cells contained in the PBMCs are transduced with anti-CD19 CAR gene by using retroviral vector.\r\nCyclophosphamide will be administered after obtaining a written informed consent and completing registration.\r\nCD19-CAR-T will be administered in the split dose. Phase 2 recommended dose will be applied for phase 1 portion. The investigator assesses efficacy of CD19-CAR-T in accordance with study-specific criteria, at 8 week after the infusion of CD19-CAR-T (or at the time of termination). The investigator also assesses the safety during the follow-up period. Long-term follow-up study is conducted at frequency of once a year for 15 years after the infusion of CD19-CAR-T in reference to guidelines of FDA.","sampling_method":"","gender":"All","minimum_age":16,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. In phase-1 study, patients must be  18 years of age. In phase-2 study, patients must\r\n             be  16 years of age.\r\n\r\n          2. Patients with relapse or refractory CD19+ acute B-cell lymphoblastic leukemia\r\n\r\n          3. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of\r\n             0, 1 or 2.\r\n\r\n          4. Patients must have adequate key organ function (bone marrow, heart, lung, liver,\r\n             renal, etc), as defined below\r\n\r\n               -  Total bilirubin level 1.5xULN (Upper limit of normal)\r\n\r\n               -  AST(GOT)/ALT(GPT) level 5.0xULN\r\n\r\n               -  Serum creatinine 2.0mg/dL\r\n\r\n               -  SpO2  92%\r\n\r\n               -  LVEF 50%\r\n\r\n          5. Patients must be able to understand and willing to sign a written informed consent\r\n             document (for patients <20 years of age their legal guardian must give informed\r\n             consent).\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. White blood cell counts  50,000/uL\r\n\r\n          2. Received expected antitumor therapy (chemotherapy or radiation therapy, etc) within 2\r\n             weeks.\r\n\r\n          3. Received HSCT within 12 weeks before enrollment.\r\n\r\n          4. Under treatment for GVHD.\r\n\r\n          5. lymphocytes except for blasts  500/uL\r\n\r\n          6. Presence of active CNS-3\r\n\r\n          7. Concurrent use of systemic steroids or immunosuppressive agents (except for\r\n             replacement therapy and local administration. e.g. inhalation, application and so on).\r\n\r\n          8. HBs Ag positive ,or either HBc Ab positive or HBs positive with HBV-DNA > 1.3LogIU/ml\r\n\r\n          9. Presence of active hepatitis C infection\r\n\r\n         10. HIV Ab or anti-HTLV-1 Ab positive\r\n\r\n         11. History of allergy about component of investigational product or animal(cattle and/or\r\n             mouse)-derived additives\r\n\r\n         12. Hypersensitivity to antibiotics.\r\n\r\n         13. Presence of symptomatic cardiac arrhythmias or serious heart disease.\r\n\r\n         14. Presence of another malignant tumor.\r\n\r\n         15. Psychiatric disorder, alcohol addiction or drug addiction that affects the ability of\r\n             informed consent.\r\n\r\n         16. Active or serious infection.\r\n\r\n         17. Both men and women who have generative functions, and who cannot agree with using\r\n             contraceptive devices from the day of the consent to the end of study.\r\n\r\n         18. Pregnant or lactating women.\r\n\r\n         19. Any other patients judged by the investigators to be inappropriate for the study.\r\n      ","sponsor":"Takara Bio Inc.","sponsor_type":"Industry","conditions":"Lymphoblastic Leukemia, Acute Adult","interventions":[{"intervention_type":"Biological","name":"Biological: TBI-1501","description":"Phase-I portion:\r\nCyclophosphamide is administered for conditioning medication of TBI1501, that is CD19-CAR-T cells, (cohort -1: 310^5 cells/kg, cohort 1: 110^6 cells/kg, cohort 2: 310^6 cells/kg).\r\nPhase-II portion:\r\nRecommended dose of Phase-II part will be administered. Cyclophosphamide will be administered as conditioning. The end of study will be Week 52 after administration of TBI-1501."}],"outcomes":[{"outcome_type":"primary","measure":"Phase-II portion: Anti-tumor effect (CR+CRi rate)","time_frame":"56 days","description":"Complete Remission (CR)+Complete Remission with Incomplete Blood Count Recovery (CRi) , as determined by assessments of peripheral blood and bone marrow."},{"outcome_type":"primary","measure":"Phase-I portion: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0","time_frame":"One year","description":"Adverse event (frequency, seriousness, duration, causality, severity, classification), mortality, severe adverse event, discontinuation due to adverse event."}]}
{"nct_id":"NCT03097172","start_date":"2017-06-01","enrollment":22,"brief_title":"The Effect of GRAVITY on Physiological Measurements During Invasive Coronary Angiography and Intervention","official_title":"The Effect of GRAVITY on Physiological Measurements During Invasive Coronary Angiography and Intervention","primary_completion_date":"2019-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2019-12-31","last_update":"2020-12-22","description":"This is a single centre observational study on the impact of change in patient position and hence gravity, on physiological measurements in coronary arteries. When patients present with heart attacks involving completely occluded heart arteries, there are signs anecdotally and in literature that arteries sitting higher up with the patient lying flat, receive less blood supply than arteries sitting lower down. The investigators believe this effect is due to the pull of gravity on the flow of blood through the heart arteries. If this is indeed the case, changing position from lying supine (patient on their back) to lying prone (patient on their front) could reverse these anatomical positions and change measurements obtained during a coronary angiogram. These measurements include pressure and flow.","other_id":"B905","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"Patients referred to the centre for 'pressure wire study' (group 1) or CTO PCI (group 2).\r\n        Referred from secondary care to tertiary centre.\r\n\r\n        Participants will be patients suffering from ischaemic heart disease living in the area\r\n        served by the tertiary centre","criteria":"\n        Group 1\r\n\r\n        Inclusion Criteria:\r\n\r\n          1. Age > 18 years of age\r\n\r\n          2. Angina symptoms or evidence of myocardial ischaemia\r\n\r\n          3. Stenosis >50% in LAD or RCA on coronary angiogram or CT coronary angiogram\r\n\r\n          4. Participant is willing and able to give informed consent\r\n\r\n          5. Eligible for PCI\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Previous CABG with any patent grafts\r\n\r\n          2. Significant left main stem stenosis\r\n\r\n          3. Lesion of interest in Circumflex artery\r\n\r\n          4. Haemodynamic Instability\r\n\r\n          5. Unable to consent\r\n\r\n          6. Unable to receive dual antiplatelet therapy\r\n\r\n          7. Contraindication to adenosine\r\n\r\n          8. Recent acute coronary syndrome (ACS) (<48 hours)\r\n\r\n          9. Pregnancy\r\n\r\n         10. Unable to lie prone\r\n\r\n         11. Severe valvular heart disease or cardiomyopathy\r\n\r\n        Group 2\r\n\r\n        Inclusion Criteria:\r\n\r\n          1. Age >18 years of age\r\n\r\n          2. Stable angina / ischaemic symptoms / and / or\r\n\r\n          3. Evidence of viability and /or ischaemia in the chronic total occlusion (CTO) territory\r\n\r\n          4. Participant is willing and able to give informed consent.\r\n\r\n          5. Presence of chronic total occlusion (CTO) in LAD or RCA\r\n\r\n          6. Eligible for PCI to a chronic total occlusion (CTO)\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Previous CABG with any patent grafts\r\n\r\n          2. Significant left main stem stenosis\r\n\r\n          3. Dominant collateral supply from circumflex artery\r\n\r\n          4. Both LAD and RCA occluded\r\n\r\n          5. Haemodynamic instability\r\n\r\n          6. Unable to receive antiplatelet therapy\r\n\r\n          7. Contraindication to adenosine\r\n\r\n          8. Recent ACS (<48 hours)\r\n\r\n          9. eGFR<40\r\n\r\n         10. Pregnancy\r\n\r\n         11. Severe valvular heart disease or cardiomyopathy\r\n\r\n         12. Contraindication to Cardiac MRI\r\n\r\n         13. Unable to lie prone\r\n      ","sponsor":"Mid and South Essex NHS Foundation Trust","sponsor_type":"Other","conditions":"Coronary Artery Disease","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Coronary physiology changes","time_frame":"5 minutes","description":"Changes in coronary physiology in the same vessel when comparing prone and supine patient position"},{"outcome_type":"secondary","measure":"MRI finding","time_frame":"4 weeks","description":"To observe any difference in ischaemia assessment when comparing prone and supine MRI"}]}
{"nct_id":"NCT03076996","start_date":"2017-06-01","phase":"N/A","enrollment":41,"brief_title":"Youth Power Action Feasibility Study of Online Support Group Intervention Among Adolescents Living With HIV in Nigeria","official_title":"Youth Power Action Feasibility Study of Online Support Group Intervention Among Adolescents Living With HIV in Nigeria","primary_completion_date":"2018-01-15","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-01-15","last_update":"2019-03-05","description":"This study will examine the feasibility and acceptability of an intervention designed to improve retention in HIV care services and improve anti-retroviral therapy (ART) adherence among adolescents ages 15-19 years living with HIV enrolled in ART services.","other_id":"930307","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","intervention_model_description":"Single group pre/post design","sampling_method":"","gender":"All","minimum_age":15,"maximum_age":19,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  HIV positive and currently on ART for at least 6 months\r\n\r\n          -  Age 15 to 19 years\r\n\r\n          -  Can demonstrate basic literacy necessary to participate in online chats\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Not planning to remain in the study area (within Akwa Ibom State) for the duration of\r\n             the study (approximately 6 months)\r\n\r\n          -  Currently enrolled in an in-person support group\r\n\r\n          -  Currently enrolled in another research study related to HIV service retention or ART\r\n             adherence\r\n\r\n          -  Critically or severely ill requiring hospitalization or such that the individual is\r\n             unable to provide informed consent at the time of study recruitment\r\n      ","sponsor":"FHI 360","sponsor_type":"Other","conditions":"HIV/AIDS|Adolescent Behavior|Medication Adherence|Health Behavior","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Online support group","description":"Participants will be enrolled to form five groups of 8 to 10 participants, and then participants will participate in the 6 sessions of the structured educational and group counseling curriculum through the online platform.\r\nThe m/eHealth intervention components include:\r\nInformational messages that reflect the content of the structured group counseling curriculum, Positive Connections, and are posted to the group wall on a regular basis\r\nModerated, closed group chats where ALHIV can interact with their peers and with a trained health counselor on a biweekly basis\r\nAccess to a trained counselor via Facebook Messenger (during normal business hours) for the duration of the intervention who will be able to provide information or basic counseling on ART/HIV care related issues, with referral to health care services as needed"}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of Active Members Who Have at Least One Post in Group Chat Session.","time_frame":"3 months","description":"Participants level of engagement in support group activities informs on the feasibility of intervention, measured by percentage of active members who have at least one post in group chat session."},{"outcome_type":"secondary","measure":"Acceptability Score","time_frame":"3 months","description":"Acceptability score: A set of ten items asking if participants agreed=1 or disagreed=0 with statements on acceptability. Score represents a sum of the 10 items with a range of 0 to 10, and a greater number indicating agreement with more acceptability items."},{"outcome_type":"secondary","measure":"Adherence to ART as Measured by the AACTG Adherence Assessment","time_frame":"3 months","description":"Proportion of participants who report not having missed any ART doses in past 3 days."},{"outcome_type":"secondary","measure":"Adherence to Follow-up Visit Within 1 Month of Scheduled Date","time_frame":"3 months","description":"Retention in HIV services will be measured using data abstracted from the medical record system on date of visits between enrollment and the endline of this study. To be considered retained in HIV services, an individual must, at 3 months after enrollment, have attended his/her most recently scheduled clinical follow-up visit within 1 month of the date when it was scheduled to take place."}]}
{"nct_id":"NCT03257514","start_date":"2017-06-01","phase":"Phase 2","enrollment":102,"brief_title":"Effect of Alpha Lipoic Acid on Uterine Scar Healing After Cesarean Section","official_title":"Assessing The Effect of Alpha Lipoic Acid on Uterine Scar Healing After Cesarean Section by Using Saline Contrast Sonohysterography","primary_completion_date":"2018-01-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-02-01","last_update":"2018-03-08","description":"The aim of this study is to evaluate the efficacy of alpha lipoic acid on uterine scar healing after cesarean section by using saline contrast sonohysterography","other_id":"maternity hospital ASU","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Triple","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":35,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Term pregnancy (gestational age between 37-41 weeks).\r\n\r\n          -  Women undergoing cesarean section for the first time.\r\n\r\n          -  Normal vaginal ultrasound examination and exclusion of any pelvic abnormality.\r\n\r\n          -  Uncomplicated cesarean section.\r\n\r\n          -  Lower uterine segment cesarean sections while the women not in labor.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Women with complications during or after cesarean section as intrapartum or postpartum\r\n             hemorrhage, puerperal sepsis, septic wound\r\n\r\n          -  Women with medical diseases that can affect the healing as diabetes mellitus, anemia,\r\n             chronic renal disease or hepatic disease or coagulopathy or receiving medications\r\n             affect wound healing as corticosteroids or anticoagulant.\r\n\r\n          -  Women who will use intrauterine device as a contraceptive method\r\n\r\n          -  Women with uterine abnormality as cervical stenosis or fibroid uterus\r\n\r\n          -  Women with pelvic infection at the time of saline sonohysterography\r\n      ","sponsor":"Ain Shams University","sponsor_type":"Other","conditions":"Cesarean Section; Dehiscence|Cesarean Scar Niche","interventions":[{"intervention_type":"Drug","name":"Drug: alpha lipoic acid drug (thioctic acid acid)","description":"Alpha lipoic acid has anti-inflammatory, antioxidant effects and plays a role in wound healing process."},{"intervention_type":"Drug","name":"Drug: Placebo Oral Tablet","description":"placebo oral drug have the same shape of thiotacid tablet"}],"outcomes":[{"outcome_type":"primary","measure":"presence of scar niche","time_frame":"six weeks after CS","description":"triangular shaped anechoic area at the site of incision"},{"outcome_type":"primary","measure":"The healing ratio","time_frame":"six weeks after CS","description":"the thickness of residual myometrium covering the defect divided by the sum of the thickness of residual myometrium cover the defect and the height of wedge shaped defect"}]}
{"nct_id":"NCT03120078","start_date":"2017-06-01","enrollment":2,"brief_title":"A Prospective Study of Diagnostic Accuracy of Ultrasound","official_title":"Diagnostic Accuracy of Ultrasound for Adenomyosis, Development of Scoring System and Correlation With Various Pelvic Pathologies: a Prospective Study.","primary_completion_date":"2017-12-14","study_type":"Observational","rec_status":"Terminated","completion_date":"2017-12-14","last_update":"2018-04-26","description":"Prospectively-Patients undergoing a hysterectomy for abnormal uterine bleeding (AUB) or pelvic pain will be enrolled in the study, will get pelvic ultrasound at the ultrasound clinic. An ultrasound will be obtained as part of the required clinical assessment before the patient undergoes a hysterectomy. The ultrasound images will be reviewed using Viewpoint reporting system-various sonographic features of adenomyosis will be reported detailed, including pelvic pathology, pelvic congestion syndrome etc. The histopathological examination will be done by assigned pathologist for accurate mapping/localizing the adenomyosis (appropriate section of uterus to defining localized versus generalized adenomyosis) on all patients diagnosed with adenomyosis on ultrasound. The ultrasound will be correlated with histopathology(which is the gold standard for diagnosis of adenomyosis). Scoring system for adenomyosis based on various sonographic features/clinical symptoms and their confirmation with histopathology will be developed.","other_id":"E17057","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"Female","minimum_age":18,"maximum_age":60,"population":"Patients undergoing hysterectomy for with AUB or pelvic pain will be enrolled in the study.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Women\r\n\r\n          -  18 years or older but 60 years or less.\r\n\r\n          -  Undergoing hysterectomy for AUB or pelvic pain\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  known cause of AUB or pelvic pain\r\n      ","sponsor":"Texas Tech University Health Sciences Center, El Paso","sponsor_type":"Other","conditions":"Adenomyosis","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Develop a scoring system for adenomyosis based on various sonographic features and clinical symptoms.","time_frame":"Duration of Study","description":"Sonographic features"},{"outcome_type":"secondary","measure":"Review the diagnostic accuracy of ultrasound with adenomyosis.","time_frame":"Duration of study","description":"Various sonographic features of adenomyosis will be reported"},{"outcome_type":"secondary","measure":"Prevalence of coexisting pathology.","time_frame":"Duration of Study","description":"Correlation with histopathology."},{"outcome_type":"secondary","measure":"Menstrual bleeding questionnaire","time_frame":"Duration of Study","description":"Comprehensive patient reported outcome instrument for heavy menstrual bleeding."}]}
{"nct_id":"NCT03174613","start_date":"2017-05-31","phase":"Phase 1","enrollment":100,"brief_title":"A Study To Evaluate The Safety, Pharmacokinetics/Pharmacodynamics (PK/PD) and Food Effect Of LC51-0255","official_title":"A Dose Blocked-randomized, Double-blind, Placebo Controlled, Single and Multiple Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamics and Food Effect of LC51-0255","primary_completion_date":"2019-06-12","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-07-11","last_update":"2020-09-18","description":"1. To evaluate the safety and tolerability of LC51-0255 in healthy male subjects 2. To evaluate the pharmacokinetic/pharmacodynamics characteristics (PK/PD) of LC51-0255 in healthy male subjects 3. To evaluate bioavailability of LC51-0255","other_id":"LG-SGCL001","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"Double","sampling_method":"","gender":"Male","minimum_age":19,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy male subjects aged 19~45 years at screening.\r\n\r\n          -  Subjects with BMI between 18.0(inclusive) and 27.0 kg/m2 (exclusive)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History or Known presence of clinically relevant hepatic, gastrointestinal, pulmonary,\r\n             psychiatric, endocrine, neurological, cancer, including solid tumors and hematological\r\n             malignancies, cardiovascular, ophthalmological or other major systemic disease\r\n\r\n          -  Exclusions Related to Laboratory Results: Platelet count < 100,000/L, Hgb < 8.5 g/dL,\r\n             Neutrophils < 1.5 /L, Absolute WBC count < 3500/L, Absolute lymphocyte count <\r\n             800/L\r\n      ","sponsor":"LG Chem","sponsor_type":"Industry","conditions":"Healthy","interventions":[{"intervention_type":"Drug","name":"Drug: LC51-0255","description":"0.25mg, 0.5mg, 1mg, 2mg, 4mg, 8mg"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"0.25mg, 0.5mg, 1mg, 2mg, 4mg, 8mg"}],"outcomes":[{"outcome_type":"primary","measure":"MTD determination","time_frame":"Dose limiting Toxicity will be evaluated at Day 19 in Single dosing study and at Day 39 in Multiple dosing study","description":"Safety and Tolerability"},{"outcome_type":"secondary","measure":"Pharmacokinetic: Peak Plasma Concentration (Cmax)","time_frame":"Cmax:168 hours post dose","description":"Cmax"},{"outcome_type":"secondary","measure":"Pharmacokinetic: Area under the plasma concentration versus time curve (AUC)","time_frame":"AUCinf:168 hours post dose","description":"AUC"}]}
{"nct_id":"NCT03069781","start_date":"2017-05-31","phase":"Early Phase 1","enrollment":0,"brief_title":"The Effects of 17-estradiol on Skeletal Muscle","official_title":"The Effects of 17-estradiol on Skeletal Muscle Mass Following Immobilization","primary_completion_date":"2018-05-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2018-08-14","last_update":"2018-08-16","description":"The maintenance of skeletal muscle mass and function is critical for healthy aging. Muscle loss with disuse, termed muscle disuse muscle atrophy, leads to impaired functional capacity, the onset of insulin resistance, as well as a heightened risk for morbidity and mortality. With advancing age there is a chronic wasting of muscle. This is especially true in women, where rapid rates of decline in muscle mass and greater anabolic resistance are experienced around the time of menopause, despite higher protein synthesis rates. As women have a longer life expectancy, they are particularly venerable to age-related frailty and morbidity. Skeletal muscle protein turnover serves to maintain the optimal function of proteins and also provides plasticity of the tissue during altered demands such as during increased loading or unloading of the muscle. Reduced periods of physical activity also have a similar, albeit milder, impact on skeletal muscle and most, people will likely experience multiple bouts of skeletal muscle disuse during their lifetime from which some, particularly older adult women, will fail to fully recover. Thus, muscle disuse atrophy is a significant and continuing problem as reclamation of lost muscle mass, strength/function, and potentially metabolic health (particularly insulin-induced glucose disposal), following disuse is oftentimes incomplete and may be further exacerbated after menopause. Previous evidence has demonstrated that in the loss of muscle mass is less pronounced in post-menopausal women when receiving hormone replacement therapy. Skeletal muscle has estrogen--receptors on the cell membrane, in the cytoplasm and on the nuclear membrane, and therefore a direct mechanistic link between low estrogen levels and a decrease MPS. Interestingly, despite higher rates of protein synthesis, older women still lose muscle mass with advancing age. It has been suggested that the negative muscle protein balance is due to an enhanced rate of MPB. Insulin is a potent inhibitor of MPB and estrogen has been shown to enhance insulin sensitivity in skeletal muscle. However, to our knowledge, no study has examined the efficacy of estrogen supplementation to attenuate the losses of skeletal muscle mass and function during a period of disuse. The findings of this investigation may yield critical data for those who wish to combat skeletal muscle disuse atrophy, particularly after menopause.","other_id":"REB-2919","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"Quadruple","intervention_model_description":"Parallel-group, double-blinded, randomized controlled trial.","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":30,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Generally healthy, non-smoking as assessed by questionnaire\r\n\r\n          2. Willing and able to provide informed consent\r\n\r\n          3. BMI between 22 and 29 kg/m2\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Any concurrent medical, orthopedic, or psychiatric condition that, in the opinion of\r\n             the Investigators, would compromise the ability to comply with the study requirements\r\n\r\n          2. Significant orthopedic, cardiovascular, pulmonary, renal, liver, infectious disease,\r\n             immune disorder, or metabolic/endocrine disorders or other disease that would preclude\r\n             oral 17-estradiol supplementation\r\n\r\n          3. Current illnesses which could interfere with the study (e.g. prolonged severe\r\n             diarrhea, regurgitation, difficulty swallowing)\r\n\r\n          4. Excessive alcohol consumption (>21 units/week)\r\n\r\n          5. History of bleeding diathesis, platelet or coagulation disorders, or\r\n             antiplatelet/anticoagulation therapy\r\n\r\n          6. Personal or family history of clotting disorder or deep vein thrombosis\r\n\r\n          7. Concomitant use of corticosteroids, testosterone replacement therapy (ingestion,\r\n             injection, or transdermal), or any anabolic steroid\r\n      ","sponsor":"McMaster University","sponsor_type":"Other","conditions":"Muscle Atrophy","interventions":[{"intervention_type":"Drug","name":"Drug: 17-estradiol","description":"1mg/day for 3-days and 3mg/day for 7-days of Estrance"},{"intervention_type":"Drug","name":"Drug: Polycose","description":"400 mg/day for 10-days of Polycose (Abbott Laboratories, St. Laurent, QC, Canada)"}],"outcomes":[{"outcome_type":"primary","measure":"Muscle protein synthesis and breakdown rates","time_frame":"Prior to immobilization (-3-0 d) and over the 7 days of immobilization (0-7 d).","description":"Myofibrillar protein will be extracted from the muscle biopsies. Myofibrillar protein-bound 2H-alanine enrichments will be determined by gas chromatography-combustion-isotope ratio mass spectrometry (GC-C-IRMS) by Metabolic Solutions, Nashua, NH as described previously (16). The saliva and plasma samples will be analyzed for 2H enrichments by cavity ring-down spectroscopy by Metabolic Solutions. Fractional synthetic rates of muscle protein synthesis will be calculated by dividing the increment in muscle protein-bound enrichment between two muscle biopsies over time by the average enrichment in total body water/plasma."},{"outcome_type":"secondary","measure":"Muscle size","time_frame":"At t=0 and after 7 days of immobilization.","description":"Ultrasound will be performed on both legs to assess leg muscle volume and mass."},{"outcome_type":"secondary","measure":"Muscle strength","time_frame":"At t=0 and after 7 days of immobilization.","description":"Muscle strength will be assessed using Biodex."}]}
{"nct_id":"NCT03811470","start_date":"2017-05-31","enrollment":500000,"brief_title":"China Diabetes Registry by Metabolic Management Center","official_title":"China Diabetes Registry - a Prospective Cohort Study of Patients With Diabetes in National Metabolic Management Centers in China","primary_completion_date":"2037-05-31","study_type":"Observational [Patient Registry]","rec_status":"Recruiting","completion_date":"2039-05-31","last_update":"2019-01-22","description":"Epidemiologic studies have revealed a tremendous increase in the prevalence of diabetes and related mortality worldwide. In order to meet all the challenges in the treatment of metabolic diseases in China, the National Metabolic Management Center (MMC) was founded in 2016. The objective of the MMC is to launch a new metabolic disease management model based on the Internet health information platform. It allows the application and evaluation of diabetes treatment strategies at these centers. The proprietary electronic medical database in the MMC will help the dynamic big-data analysis in diabetes epidemiology, prevention, diagnosis, and treatment. It will also provide prospective data support including economic evaluation in management of chronic diseases for the Healthy China 2030 strategy. Objective 1. The purpose of the present study is to establish a multi-center nationwide prospective database of diabetes patients in MMCs, including clinical data, biological samples library so as to explore the epidemiology, genetics, new biomarkers, risk factors, and prognostic methods related to diabetes and its complications, as well as other metabolic diseases. 2. To collect cross-sectional data from patients seen and treated at each MMC centers so as to evaluate: the current status of care of patients with diabetes and its related complications, as well as other risk factors treatment strategies at these centers. Patients'costs and quality of life (QoL) will also be evaluated. 3. To collect the prospective data of patients treated at each MMC centers in order to evaluate the strategies for the achievement of treatment goals, changes in management, control of risk factors, incidence and progression of all-diabetes related clinical endpoints (including mortality), behavioral changes, psychological well being as well as costs and QoL.","other_id":"CCEMD-2018-1201","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":75,"population":"All the patients who are seen and treated at each MMC centers, and meet the In-/Ex-clusion\r\n        Criteria will be included in this study","criteria":"\n        Main Inclusion Criteria:\r\n\r\n          -  Age  18 years old and  75 years\r\n\r\n          -  Diagnosis of diabetes mellitus according to 1999 WHO criteria\r\n\r\n          -  Gender: males and females\r\n\r\n          -  Provide written informed consent\r\n\r\n          -  Satisfactory compliance\r\n\r\n        Main Exclusion Criteria:\r\n\r\n          -  Patients with significantly reduced life expectancy (less than 5 years)\r\n\r\n          -  With Drug abuse\r\n\r\n          -  With AIDS or syphilis or infectious diseases such as viral hepatitis or tuberculosis\r\n             in active phase at enrollment\r\n      ","sponsor":"Guang Ning","sponsor_type":"Other","conditions":"Type 2 Diabetes Mellitus|Type1 Diabetes Mellitus|Monogenetic Diabetes|Pancreatogenic Diabetes|Drug-Induced Diabetes Mellitus|Other Forms of Diabetes Mellitus","interventions":[{"intervention_type":"Other","name":"Other: Standard diabetes management model in each MMC center","description":"Standard diabetes management model in each MMC center"}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of all diabetes-related clinical endpoints; including: 1. Macrovascular morbidity","time_frame":"through study completion, up to 20 years"},{"outcome_type":"primary","measure":"Microvascular morbidity","time_frame":"through study completion, up to 20 years"},{"outcome_type":"primary","measure":"Mortality","time_frame":"through study completion, up to 20 years"},{"outcome_type":"primary","measure":"Major infections - pulmonary and non-pulmonary requiring hospitalizations","time_frame":"through study completion, up to 20 years"},{"outcome_type":"primary","measure":"Heart failure","time_frame":"through study completion, up to 20 years","description":"including hospitalized or treated heart failure, or heart failure death"},{"outcome_type":"primary","measure":"Neuropathy","time_frame":"through study completion, up to 20 years","description":"defined as a composite score by the assessment of positive responses among symptoms (by a careful history), sensory signs, or absent or hypoactive reflexes consistent with a distal symmetrical polyneuropathy, and at least one abnormal nerve conduction"},{"outcome_type":"primary","measure":"All cancers","time_frame":"through study completion, up to 20 years","description":"The occurrence of any of the following cancers: prostate, breast, lung/bronchus, endometrial, colon, gastric, leukemia, lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma, etc"},{"outcome_type":"secondary","measure":"HbA1c (%)","time_frame":"through study completion, up to 20 years"},{"outcome_type":"secondary","measure":"Fasting and postprandial glucose (mmol/L)","time_frame":"through study completion, up to 20 years"},{"outcome_type":"secondary","measure":"Blood pressures (mmHg)","time_frame":"through study completion, up to 20 years"},{"outcome_type":"secondary","measure":"lipids (mg/dl)","time_frame":"through study completion, up to 20 years"},{"outcome_type":"secondary","measure":"Body mass index (BMI)","time_frame":"through study completion, up to 20 years","description":"Body weight (kg) and height (m) will be combined to report BMI in kg/m^2"},{"outcome_type":"secondary","measure":"Visceral fat (cm^2)","time_frame":"through study completion, up to 20 years"},{"outcome_type":"secondary","measure":"Health related quality of life","time_frame":"through study completion, up to 20 years","description":"Evaluated with HQoL scales such as Short Form 12 Health Survey Questionnaire"},{"outcome_type":"secondary","measure":"Cognitive function","time_frame":"through study completion, up to 20 years","description":"Incidences of all-cause dementia and mild cognitive impairment, cognitive function assessed by cognitive function scale"},{"outcome_type":"secondary","measure":"Psychological well being","time_frame":"through study completion, up to 20 years","description":"using physiological parameter, questionnaire"},{"outcome_type":"secondary","measure":"Cost-effectiveness","time_frame":"through study completion, up to 20 years","description":"The incremental cost per quality adjusted life year (QALY) gained. QALYs will be measured by the EuroQol-5 Dimensions (EQ-5D) questionnaire"}]}
{"nct_id":"NCT03111706","start_date":"2017-05-31","enrollment":300,"brief_title":"2D and 3D Ultrasound Assessment of Cesarean Section Scars","official_title":"2D and 3D Ultrasound Assessment of Cesarean Section Scars and Its Correlation to Intraoperative Findings","primary_completion_date":"2018-05-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2018-07-31","last_update":"2017-04-14","description":"Prospective observational study conducted on women with previous 1 or 2 CS candidate for elective CS. Ultrasonographic evaluation of lower uterine segment using 2D and 3D transabdominal and transvaginal then correlated to scar integrity assessed intraoperatively","other_id":"165","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"Female","minimum_age":19,"maximum_age":44,"population":"women with prior 1 or 2 cesarean sections candidate for elective cesarean sewction","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  37 - 40 weeks of gestational age\r\n\r\n          -  singleton pregnancy,\r\n\r\n          -  cephalic presentation,\r\n\r\n          -  not in labor\r\n\r\n          -  intact membranes\r\n\r\n          -  with history of one or two previous CS\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  disorders of amniotic fluid,\r\n\r\n          -  placenta previa\r\n\r\n          -  history of other uterine surgery, e.g, myomectomy\r\n      ","sponsor":"Cairo University","sponsor_type":"Other","conditions":"Cesarean Wound Disruption","interventions":[{"intervention_type":"Procedure","name":"Procedure: Cesarean section","description":"During Cesarean delivery the lower uterine segment (LUS) was defined as the part of the uterus below the uterovesical peritoneal reflection. After opening the visceral peritoneum and performing the bladder dissection, the LUS was assessed for integrity of the CS scar by the operating surgeon to avoid bias by the sonographic findings. Scar dehiscence was defined as the presence of either transparent LUS with visible contents, presence of well-circumscribed scar defect or presence of frank uterine rupture."}],"outcomes":[{"outcome_type":"primary","measure":"Scar dehiscence","time_frame":"At time of surgery","description":"as the presence of either transparent LUS with visible contents, presence of well-circumscribed scar defect or presence of frank uterine rupture."}]}
{"nct_id":"NCT03204695","start_date":"2017-05-29","phase":"Phase 3","enrollment":65,"brief_title":"WAVECREST Post Market Clinical Follow-Up (PMCF) Study","official_title":"A Prospective, Multicenter, Non-randomized, Post-market Clinical Follow-up Study to Confirm Safety and Performance of the Coherex WaveCrest Left Atrial Appendage Occlusion System in Patients With Non-valvular Atrial Fibrillation","primary_completion_date":"2022-12-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2023-03-31","last_update":"2021-09-08","description":"The WAVECREST PMCF Study is a prospective, non-randomized, multicenter study to confirm safety and performance of the Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System in the current medical practice setting in patients with non-valvular atrial fibrillation who are at increased risk for stroke. Up to 65 subjects may be enrolled at up to 15 study sites in Europe. Patients will be followed through 45 days post-procedure.","other_id":"CHX_IP015","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        The criteria for implant are in accordance to the current version of the Instructions for\r\n        Use:\r\n\r\n        Inclusion Criteria:\r\n\r\n          1. Non-valvular paroxysmal, persistent, or permanent atrial fibrillation\r\n\r\n          2. 18 years of age or older\r\n\r\n          3. LAA anatomy amenable to treatment by percutaneous techniques\r\n\r\n          4. Risk factors for potential thrombus formation in the LAA\r\n\r\n          5. Willing to participate in the required follow-up visits and tests\r\n\r\n          6. Subject has been informed of the nature of the study, agrees to its provisions and has\r\n             provided written informed consent as approved by the Ethics Committee or Institutional\r\n             Review Board at the study site\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Known contraindication to percutaneous transseptal intervention\r\n\r\n          2. Left atrial appendage anatomy or size that will not allow appropriate implantation of\r\n             the WaveCrest Implant\r\n\r\n          3. Intracardiac thrombus or other cardiac abnormality visualized prior to implant that\r\n             would significantly impact procedural safety\r\n\r\n          4. Mitral valve stenosis < 1.5 cm2 or any stenosis consistent with rheumatic valvular\r\n             disease or history of mitral valve replacement or repair\r\n\r\n          5. Known contraindication and/or allergy to nickel\r\n\r\n          6. Known active bacterial infection (i.e., sepsis, endocarditis)\r\n\r\n          7. Any known medical condition or overall health of the subject that could adversely\r\n             affect procedural safety or potentially prevent the patient from completing all study\r\n             required visits and tests.\r\n\r\n          8. Pregnant or breastfeeding women due to the risk of exposure to x-rays and medications\r\n             associated with the implant procedure.\r\n      ","sponsor":"Coherex Medical","sponsor_type":"Industry","conditions":"Non-valvular Atrial Fibrillation","interventions":[{"intervention_type":"Device","name":"Device: Percutaneous LAA Closure","description":"LAA Closure with the WaveCrest LAA Occlusion System (study device)"}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of all-cause deaths and device and/or procedure related events while using the WaveCrest device","time_frame":"45 Days","description":"Composite rate consists of:\r\nAll-cause mortality\r\nPericardial effusion requiring intervention\r\nDevice embolization from the Left Atrial Appendage (LAA)\r\nDevice thrombus\r\nIschemic stroke"},{"outcome_type":"secondary","measure":"Rate of successful device release within LAA","time_frame":"Intraoperative","description":"Position confirmed by imaging"},{"outcome_type":"secondary","measure":"Technical Success at implant","time_frame":"Intraoperative","description":"Occlusion of the LAA\r\nNo device-related complications\r\nNo leak >5mm on color Doppler Transesophageal Echocardiography (TEE)"},{"outcome_type":"secondary","measure":"Procedural Success","time_frame":"Intraoperative","description":"Technical success\r\nNo procedure-related complications except uncomplicated (minor) device embolization (resolved by percutaneous retrieval during the procedure without surgical intervention or damage to surrounding cardiovascular structures)"}]}
{"nct_id":"NCT03296683","start_date":"2017-05-23","phase":"N/A","enrollment":1200,"brief_title":"Evaluation of a 3D Functional Metabolic Imaging and Risk Assessment System in Classifying Women for Likelihood of Breast Cancer","official_title":"Evaluation of a Three Dimensional Functional Metabolic Imaging and Risk Assessment System in Classifying Women for Likelihood of Breast Cancer","primary_completion_date":"2019-09-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2021-09-30","last_update":"2018-06-19","description":"The study objective is to evaluate the added value of MIRA technology as an adjunct to mammography in the detection of malignant breast lesions in women with dense breast and/or at elevated risk of breast cancer.","other_id":"960-CLP-ITL_RI8 _ITS1","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Screening","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":24,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        **Calibration Phase:\r\n\r\n        A.Subjects who are asymptomatic and scheduled to undergo routine screening mammography.\r\n\r\n        OR\r\n\r\n        B.Subjects scheduled for image guided needle biopsy as a result of findings obtained during\r\n        standard of care (mammography, ultrasound and/or MRI)\r\n\r\n        **Testing Phase:\r\n\r\n        A. Subjects scheduled to undergo routine screening mammography and at least one of the\r\n        following :\r\n\r\n          -  Subjects whose most recent (within 3 years) prior mammogram was interpreted as\r\n             heterogeneously dense (ACR BI-RADS Breast Density 3) or extremely dense (ACR BI-RADS\r\n             Breast Density 4).\r\n\r\n          -  Subjects whose current 10-year IBIS breast cancer risk is 5% or higher.\r\n\r\n        EXCLUSION CRITERIA, valid for both calibration and testing phases:\r\n\r\n          1. Male by birth.\r\n\r\n          2. Individual is less than 24 years old.\r\n\r\n          3. Contraindication to bilateral mammography or MRI.\r\n\r\n          4. Subjects who are unable to read, understand and execute the informed consent\r\n             procedure.\r\n\r\n          5. Subjects who have had mammography, ultrasound or MRI examination performed on the day\r\n             of the study prior to MIRA scan.\r\n\r\n          6. Subjects who have significant existing breast trauma.\r\n\r\n          7. Subjects who have undergone lumpectomy/mastectomy.\r\n\r\n          8. Subjects who have undergone breast reduction or breast augmentation.\r\n\r\n          9. Subjects who have undergone any other type of breast surgery.\r\n\r\n         10. Subjects who have large breast scar / Breast deformation.\r\n\r\n         11. Subjects who have undergone a breast needle biopsy within the 6 month period prior to\r\n             their intended enrollment into the study.\r\n\r\n         12. Subjects who have a temperature > 100 F (37.8C) degrees on the day of the MIRA\r\n             imaging.\r\n\r\n         13. Subjects who are pregnant or lactating.\r\n\r\n         14. Subjects who have had placement of an internal breast marker.\r\n\r\n         15. Subjects with known Raynaud's Disease.\r\n\r\n         16. Subjects that are claustrophobic or have physical limitations that do allow them to\r\n             sit in the system chair for the required imaging session.\r\n\r\n         17. Subjects with implanted pacemaker/defibrillator, implanted venous access device\r\n             (portacath) or other implanted devices.\r\n\r\n         18. Subjects with a BI-RADS category 6 (e.g. for which mammogram was performed for the\r\n             purpose of planning cancer therapy).\r\n\r\n         19. Subjects affected with epilepsy.\r\n\r\n         20. Subjects who participated in the Calibration Phase will not be able to participate in\r\n             the Testing Phase.\r\n      ","sponsor":"Real Imaging Ltd.","sponsor_type":"Industry","conditions":"Breast Cancer","interventions":[{"intervention_type":"Device","name":"Device: MIRA device imaging","description":"MIRA Device imaging for adjunctive detection of breast cancer"}],"outcomes":[{"outcome_type":"primary","measure":"Increase in incremental cancer detection rate","time_frame":"24 months","description":"Statistically significant increase of 30% or more in incremental cancer detection rate"}]}
{"nct_id":"NCT03168685","start_date":"2017-05-22","phase":"N/A","enrollment":20,"brief_title":"Hemophilia Mobile App Usability Pilot","official_title":"Bayer/HITLAB - Hemophilia Mobile App Usability Pilot","primary_completion_date":"2018-05-11","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2018-05-11","last_update":"2018-04-19","description":"The purpose of this study is to evaluate the utility and user experience of a smart phone app for people with medical conditions, used in conjunction with an ActiGraph wearable device and a connected scale.","other_id":"Pro00021564","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Device Feasibility","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":63,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. You own an iPhone or a Samsung (S5 or higher) smartphone\r\n\r\n          2. Your age is between 18 and 63 years\r\n\r\n          3. You reside in the New York metropolitan area\r\n\r\n          4. You are able to read, write, and speak English\r\n\r\n          5. You have participated in a concluded clinical trial in the past two years\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. You do not own an iPhone or a Samsung (S5 or higher) smartphone\r\n\r\n          2. Your age is not between 18 and 63 years\r\n\r\n          3. You do not reside in the New York metropolitan area\r\n\r\n          4. You are not able to read, write, and speak English\r\n\r\n          5. You have not participated in a concluded clinical trial in the past two years\r\n      ","sponsor":"Healthcare Innovation Technology Lab","sponsor_type":"Industry","conditions":"Hemophilia","interventions":[{"intervention_type":"Device","name":"Device: SureSource Engage application","description":"Eligible patients who choose to participate in the study will be asked to wear an actigraphy device [ActiGraph GT9X Link \"Actigraph Link\"] on their wrist continuously during both 4-week study phases.\r\nThe ActiGraph Link is a small (3.5 X 3.5 X 1 cm) wristwatch like device weighing approximately 14 grams that measures indicators of the wearer's activity and sleep patterns, including: acceleration, energy expenditure, steps, basal metabolic rate, activity intensity, sleep time, sleep efficiency, sleep latency, and body position.\r\nThe application being utilized is SureSource Engage application from Clinical Ink. The application is compatible to most Android and iOS devices.\r\nParticipants will also use a basic Bluetooth-enabled weight scale that syncs with the application."}],"outcomes":[{"outcome_type":"primary","measure":"Usage of the SureSource Engage application as assessed by ActiLife software","time_frame":"128 days"},{"outcome_type":"primary","measure":"Device usability as assessed by the System Usability Scale (SUS)","time_frame":"128 days"}]}
{"nct_id":"NCT03158324","start_date":"2017-05-22","phase":"Phase 2","enrollment":52,"brief_title":"Phase IIa Dose-Expansion and Biomarker Study of OPB-111077","official_title":"Phase IIa Dose-Expansion and Biomarker Study of OPB-111077 in An Enriched Population of Treatment-Refractory Advanced Solid Tumors","primary_completion_date":"2020-05-22","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2020-11-30","last_update":"2017-06-15","description":"This is a phase IIa open-label, non-randomized dose-expansion study of OPB-111077 in patients with advanced, treatment refractory cancers who have biopsy-amenable lesions at study entry.","other_id":"2016/01181","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Two parallel cohorts will be implemented: i. patients with tumors predicted to be dependent on oxidative phosphorylation metabolism or oncogene addicted tumors which have developed resistance to primary TKI therapy, or ii. patients with nasopharyngeal carcinoma","sampling_method":"","gender":"All","minimum_age":21,"maximum_age":99,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Histologically confirmed, locally recurrent or metastatic solid tumors, who have\r\n             failed standard treatment\r\n\r\n          2. Subjects with NPC will be eligible as long as they have received prior platinum\r\n             therapy\r\n\r\n          3. Subjects with other types of solid tumors will be eligible if: i) their archival tumor\r\n             sample shows over-expression oxidative phosphorylation markers e.g., PGC-1/ SIRT1 or\r\n             ii) they have oncogene-addicted cancers (e.g., EGFR mutation-positive NSCLC, EML4-ALK\r\n             fusion NSCLC, BRAF-mutant melanomas, GIST, RET-driven thyroid cancers) which have\r\n             become resistant to primary TKI therapy\r\n\r\n          4. All subjects must have at least one tumour lesion (primary or metastatic) that is\r\n             suitable for free-hand or image-guided biopsy at baseline.\r\n\r\n          5. Age  21 years, Eastern Cooperative Oncology Group (ECOG) performance status < 1\r\n\r\n          6. Adequate bone marrow, liver and renal function\r\n\r\n          7. Baseline serum lactate <3mmol/l\r\n\r\n          8. Capable of swallowing tablets\r\n\r\n          9. Recovery from any previous drug- or procedure-related toxicity to National Cancer\r\n             Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 Grade\r\n             0 or 1 (except alopecia), or to baseline preceding the prior treatment.\r\n\r\n         10. Signed informed consent obtained before any study specific procedure. Subjects must be\r\n             able to understand and be willing to sign the written informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Chemotherapy, radiotherapy, surgery, immunotherapy or other therapy within 3 weeks of\r\n             starting investigational medicinal product (IMP).\r\n\r\n          2. Use of any prohibited medications (CYP3A4 inhibitors and inducers) or medications\r\n             which may predispose to lactic acidosis (e.g., metformin, nucleoside analogue reverse\r\n             within 1 week prior to start of study drug administration\r\n\r\n          3. Pregnancy or breastfeeding.\r\n\r\n          4. Women of childbearing potential not employing adequate contraception. Women of\r\n             childbearing potential must have a pregnancy test performed a maximum of 7 days before\r\n             start of study medication, and a negative result must be documented before start of\r\n             study medication. Women of childbearing potential and men, must agree to use adequate\r\n             contraception (barrier method of birth control) upon signing the informed consent form\r\n             until at least 3 months after the last study drug administration.\r\n\r\n          5. Known or suspected allergy to the investigational agent or any agent given in\r\n             association with this study.\r\n\r\n          6. Concurrent cancer which is distinct in primary site or histology from the cancer being\r\n             evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell\r\n             carcinoma, superficial bladder tumours (Ta, Tis & T1) or any cancer curatively treated\r\n             less than 3 years prior to study entry.\r\n\r\n          7. Interstitial lung disease with ongoing signs and symptoms at the time of screening.\r\n\r\n          8. Patients with CTCAE Grade 2 or higher peripheral neuropathy.\r\n\r\n          9. History of significant cardiac disease: congestive cardiac failure > NYHA class II,\r\n             ongoing unstable angina, new-onset angina or myocardial infarction within the past 3\r\n             months\r\n      ","sponsor":"National University Hospital, Singapore","sponsor_type":"Other","conditions":"NPC|Refractory Tumor","interventions":[{"intervention_type":"Drug","name":"Drug: OPB-111077","description":"Receive 600 mg of OPB-111077 on a 4 days-on, 3 days-off per week in 28-day cycles till disease progression or intolerable toxicity"}],"outcomes":[{"outcome_type":"primary","measure":"Objective response rates","time_frame":"3 years","description":"This will be calculated as the percentage of evaluable patients achieving complete and partial response with OPB-111077 treatment, according to the RECIST 1.1 criteria"},{"outcome_type":"secondary","measure":"Metabolic response rates","time_frame":"3 years","description":"This will be calculated as the percentage of evaluable patients achieving complete and partial metabolic response on 18F]-FDG PET/CT after 2 cycles of OPB-111077, as determined by the EORTC PET response criteria."},{"outcome_type":"secondary","measure":"Progression free survival","time_frame":"3 years","description":"This is defined as the time from the start of study treatment to documented progression of disease or death."},{"outcome_type":"secondary","measure":"Haematologic and non-haematologic toxicities (all grades)","time_frame":"3 years","description":"To evaluate the haematologic and non-haematologic toxicities of OPB-111077"}]}
{"nct_id":"NCT04493918","start_date":"2017-05-21","phase":"Phase 2","enrollment":20,"brief_title":"Effectivity of Mesenchymal Stem Cell on Vertebral Bone Defect Due to Mycobaterium Tuberculosis Infection","official_title":"Effectivity of Local Implantation of the Mesenchymal Stem Cell on Vertebral Bone Defect Due to Mycobaterium Tuberculosis Infection (Clinical Trial)","primary_completion_date":"2020-12-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2020-12-30","last_update":"2020-08-03","description":"This study evaluates the effectiveness of locally implantation of mesenchymal stem cell on vertebral bone defects due to infection of mycobacterium tuberculosis. there are controlled participants who receives placebo and patients who receives implantation of MSc","other_id":"18-04-0389","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":15,"maximum_age":64,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Clinicoradiologically diagnoses Spinal Tuberculosis\r\n\r\n          -  receives Anti TB drugs\r\n\r\n          -  minimun destruction 1/3 vertebral body\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  patient under 15 years old\r\n\r\n          -  reject to be included in the study\r\n      ","sponsor":"Ahmad Jabir Rahyussalim","sponsor_type":"Other","conditions":"Spinal Tuberculosis|Mesenchymal Stem Cell","interventions":[{"intervention_type":"Combination Product","name":"Combination Product: Mesenchymal Stem cell + Nacl 0.9%","description":"Patient who undergo surgery, debridement, decompression and posterior stabilization injection with Nacl 0.9% 2 ml + MSC 30 million unit"},{"intervention_type":"Combination Product","name":"Combination Product: NaCl 0.9%","description":"Patient who undergo surgery, debridement, decompression and posterior stabilization injection with Nacl 0.9% 2 ml"}],"outcomes":[{"outcome_type":"primary","measure":"Vertebral bony fusion","time_frame":"1 Year","description":"trabecular bone on xray and CT scan"}]}
{"nct_id":"NCT03125304","start_date":"2017-05-21","phase":"N/A","enrollment":106,"brief_title":"Acupuncture for Pain of Endometriosis","official_title":"Acupuncture for Pain of Endometriosis: A Multicenter, Randomized, and Controlled Trial","primary_completion_date":"2021-04-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-05-30","last_update":"2020-12-22","description":"This proposed trial is a multicenter,randomized and controlled clinical trial. The aim of this trial is to evaluate the efficacy and safety of acupuncture for treating pain of Endometriosis.The trial period will consist of three menstrual cycles of treatment, and three menstrual cycles in the follow-up period.We put forward the following hypothesis: the effect of acupuncture group is better than the control group on relieving pain.","other_id":"jdzy2015065","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","intervention_model_description":"The participants assigned to the treatment groups will receive acupuncture at Sanyinjiao (SP 6), Zhaohai (KI 6) ,Taichong (LR 3) ,Qichong (ST 30) and Guanyuan (CV4), while the control group will receive acupuncture at non-acupoint.","sampling_method":"","gender":"Female","minimum_age":20,"maximum_age":40,"population":"","criteria":"\n        Inclusion criteria\r\n\r\n          1. Women age between 20 and 40.\r\n\r\n          2. Endometriosis diagnosed according to the Endometriosis Consensus Guidelines (Chinese\r\n             Medical Association, 2015): 1) symptomatic endometriosis detected by laparoscopy or\r\n             laparotomy; or 2) ovarian endometrioma detected by ultrasound or magnetic resonance\r\n             imaging with pelvic pain.\r\n\r\n          3. Patients willing to receive acupuncture for pain relief.\r\n\r\n          4. Pelvic pain score equal or over 4 cm on the Visual Analogue Scale (VAS).\r\n\r\n          5. Regular menstrual cycle.\r\n\r\n          6. Signed informed consent\r\n\r\n        Exclusion criteria\r\n\r\n          1. Pelvic ultrasound demonstrates the endometrial cyst measures more than 5 cm in\r\n             diameter and surgery is indicated.\r\n\r\n          2. Imaging examination suspects pelvic genital malignancies.\r\n\r\n          3. Cancer antigen-125 > 200 IU/L.\r\n\r\n          4. Pelvic infectious diseases.\r\n\r\n          5. Other severe disorders in heart, lung, liver, kidney, or mental disorders not able to\r\n             cooperate in the study.\r\n\r\n          6. Patients who have received any other treatment for endometriosis that may affect the\r\n             observation of the curative effects of acupuncture these three months.\r\n\r\n          7. Pregnancy or breastfeeding.\r\n\r\n          8. Refusal to be randomized.\r\n      ","sponsor":"State Administration of Traditional Chinese Medicine of the People's Republic of China","sponsor_type":"Other","conditions":"Endometriosis","interventions":[{"intervention_type":"Other","name":"Other: acupuncture","description":"They will be treated seven days before expected menstrual onset with once a day and three times a week for therapy. During the menstrual period,they will be treated everyday when they are having pain.Every treatment lasts 30 minutes. The trial period will consist of three menstrual cycles of treatment and three menstrual cycles in the follow-up period."}],"outcomes":[{"outcome_type":"primary","measure":"Visual analogue scale","time_frame":"up to 24 weeks","description":"Pelvic pain"},{"outcome_type":"secondary","measure":"Endometriosis Health Profile -30","time_frame":"up to 24 weeks","description":"Endometriosis-specific quality of life"},{"outcome_type":"secondary","measure":"Multidimensional Pain Inventory","time_frame":"up to 24 weeks","description":"Physical functioning"},{"outcome_type":"secondary","measure":"Beck Depression Inventory and Profile of Mood States","time_frame":"up to 24 weeks","description":"Emotional functioning"},{"outcome_type":"secondary","measure":"Patient Global Impression of Change","time_frame":"up to 24 weeks","description":"Patient satisfaction"},{"outcome_type":"secondary","measure":"Pain diary","time_frame":"up to 24 weeks","description":"the specific time and frequency of pain attacks, the duration of pain"}]}
{"nct_id":"NCT03269279","start_date":"2017-05-20","phase":"Phase 3","enrollment":100,"brief_title":"Mifepristone and Misoprostol for 2nd Trimester Termination of Pregnancy in Burkina Faso","official_title":"Mifepristone and Misoprostol for 2nd Trimester Termination of Pregnancy (13-22 Weeks LMP) in Burkina Faso","primary_completion_date":"2019-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-12-31","last_update":"2019-05-30","description":"The goal of this study is to examine the effectiveness and feasibility of a mifepristone-misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in Burkina Faso.","other_id":"1036","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Having an ongoing pregnancy of 13-22 weeks gestation\r\n\r\n          -  Be willing to undergo surgical completion if necessary\r\n\r\n          -  Have no contraindications to study procedures, according to provider\r\n\r\n          -  Be willing and able to consent to participate in the study\r\n\r\n          -  Be willing to follow study procedures\r\n\r\n          -  Respect legal indications for obtaining an abortion\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Known allergy to mifepristone or misoprostol/prostaglandin\r\n\r\n          -  Any contraindications to vaginal delivery, including placenta previa\r\n\r\n          -  Previous transmural uterine incsion\r\n      ","sponsor":"Gynuity Health Projects","sponsor_type":"Other","conditions":"Medical; Abortion, Fetus","interventions":[{"intervention_type":"Drug","name":"Drug: Mifepristone","description":"Medication used in conjunction with misoprostol for abortion"},{"intervention_type":"Drug","name":"Drug: Misoprostol","description":"Medication used in conjunction with mifepristone for abortion"}],"outcomes":[{"outcome_type":"primary","measure":"Rate of successful abortion","time_frame":"24 hours","description":"Rate of successful abortion, complete evacuation of foetus and placenta with study drugs, within 24 hours of taking misoprostol"}]}
{"nct_id":"NCT03170674","start_date":"2017-05-15","phase":"N/A","enrollment":114,"brief_title":"CSD170501: Study to Assess Biomarkers of Tobacco Exposure in Smokers During In-Clinic Confinement Switch to an Electronic Cigarette","official_title":"CSD170501: A Randomized, Controlled Study to Assess Biomarkers of Tobacco Exposure in Smokers During In-Clinic Confinement Switch to an Electronic Cigarette","primary_completion_date":"2017-08-18","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-08-18","last_update":"2017-09-08","description":"The purpose of this clinical study is to evaluate changes in biomarkers of exposure (BOE) to tobacco smoke constituents after smokers switch from combustible cigarettes to use of one of the three electronic cigarettes or abstinence.","other_id":"CSD170501","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":21,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Able to read, understand, and willing to sign an Informed Consent Form (ICF) and\r\n             complete questionnaires written in English;\r\n\r\n          2. Generally healthy males or females, 21 to 60 years of age (inclusive);\r\n\r\n          3. Screening expired carbon monoxide (ECO) level  12 parts per million (ppm);\r\n\r\n          4. Self-reports that cigarettes are the only tobacco or nicotine-containing product used\r\n             within 30 days of the Screening Visit (Note: Rare use of other products [e.g., cigar\r\n             or bridging therapy with NRT] may be acceptable in consultation with the Sponsor);\r\n\r\n          5. Self-reports at the Screening Visit smoking on average at least 10 cigarettes per day\r\n             that are filtered, non-menthol, 83 mm to 100 mm length and inhaling the smoke for at\r\n             least 6 months prior to the Screening Visit (Note: Smokers who use menthol cigarette\r\n             products like Camel Crush are not eligible for the study);\r\n\r\n          6. Positive urine cotinine test at Screening and Enrollment;\r\n\r\n          7. Willing to switch from current cigarette to one of the Investigational Products or to\r\n             abstain from smoking for approximately 7 days during in-clinic confinement;\r\n\r\n          8. Females of childbearing potential must be willing to use a form of contraception\r\n             acceptable to the Investigator from the time of signing the ICF until Study Discharge\r\n             or be surgically sterile for at least 90 days prior to the Screening Visit;\r\n\r\n          9. Able to safely perform the required study procedures, as determined by the\r\n             Investigator.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Clinically significant or unstable/uncontrolled acute or chronic medical conditions at\r\n             screening, as determined by the Investigator, that would preclude a subject from\r\n             participating safely in the study (e.g., hypertension, chronic lung disease, heart\r\n             disease, neurological disease, or psychiatric disorders) based on screening\r\n             assessments such as safety labs, medical history, and physical/oral examinations;\r\n\r\n          2. Self-reports or safety labs that indicate diabetes;\r\n\r\n          3. Use of medicine for treatment of depression, unless on a stable dose for the past 6\r\n             months prior to screening and deemed clinically stable by the PI.\r\n\r\n          4. Current scheduled treatment for asthma within the past consecutive 12 months prior to\r\n             screening. As needed treatment, such as inhalers, may be included at the PIs\r\n             discretion pending approval from the medical monitor.\r\n\r\n          5. Any history of cancer, except for primary cancers of skin such as localized basal\r\n             cell/squamous cell carcinoma that has been surgically and/or cryogenically removed.\r\n\r\n          6. Systolic blood pressure of > 160 mmHg or a diastolic blood pressure of > 95 mmHg,\r\n             measured after being seated for 5 minutes (at Screening or Day -2 Check-in);\r\n\r\n          7. Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen\r\n             (HBsAg), or hepatitis C virus antibody (anti-HCV);\r\n\r\n          8. Clinically significant hemoglobin level, < 5% of the Lower Limit of Normal (LLN), as\r\n             determined by the Investigator at Screening;\r\n\r\n          9. History or presence of hemophilia or any other bleeding or clotting disorders;\r\n\r\n         10. Use of anticoagulants (e.g., clopidogrel [Plavix], warfarin [Coumadin, Jantoven],\r\n             aspirin [> 325 mg/day]) at least 30 days prior to screening;\r\n\r\n         11. Given a whole blood donation within 8 weeks (56 days) prior to enrollment;\r\n\r\n         12. Plasma donation within  7 days prior to enrollment;\r\n\r\n         13. Weight of  110 pounds;\r\n\r\n         14. Postponing a decision to quit smoking (defined as planning a quit attempt within 30\r\n             days of Screening) to participate in this study;\r\n\r\n         15. Employed by a tobacco company, the clinical study site, or handles e-liquids or\r\n             unprocessed tobacco as part of his/her job;\r\n\r\n         16. Use of any medication or supplement that aids in smoking cessation including, but not\r\n             limited to, any nicotine replacement therapy (NRT) unless used for short term bridging\r\n             therapy (e.g., nicotine gum, lozenge, patch), varenicline (Chantix), bupropion\r\n             (Wellbutrin, Zyban), or lobelia extract within 30 days of the Screening Visit;\r\n\r\n         17. Use of injectable forms of medication(s) for the duration of the study, unless\r\n             acceptable in the opinion of the Investigator or with the exception of injectable\r\n             forms of birth control that are not required to be administered during the study\r\n             period;\r\n\r\n         18. Self-reports drinking more than 14 servings of alcoholic beverages per week (1 serving\r\n             = 12 oz of beer, 6 oz of wine, or 1.5 oz of liquor);\r\n\r\n         19. Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to\r\n             become pregnant during the course of the study;\r\n\r\n         20. Females 35 years of age currently using systemic, estrogen-containing contraception,\r\n             or hormone replacement therapy for menopause-related symptoms;\r\n\r\n         21. A positive urine drug screen without disclosure of corresponding prescribed\r\n             concomitant medication(s) at the Screening Visit or Enrollment;\r\n\r\n         22. A positive alcohol test at Screening or Enrollment;\r\n\r\n         23. Regularly exposed to solvent fumes or gasoline (e.g., painter, auto mechanic);\r\n\r\n         24. Participation in another clinical study within 30 days prior to the time of consent.\r\n             The 30-day window for each subject will be derived from the date of the last study\r\n             event in the previous study to time of consent of the current study;\r\n\r\n         25. Determined by the Investigator to be inappropriate for this study, including a subject\r\n             who is unable to communicate or unwilling to cooperate with the clinical staff;\r\n\r\n         26. Unable or unwilling to participate in the in-clinic confinement for the full study\r\n             duration (total of 10 days).\r\n      ","sponsor":"RAI Services Company","sponsor_type":"Industry","conditions":"Smoking","interventions":[{"intervention_type":"Other","name":"Other: FT21039","description":"an electronic cigarette product"},{"intervention_type":"Other","name":"Other: FT21092","description":"an electronic cigarette product"},{"intervention_type":"Other","name":"Other: FT21018","description":"an electronic cigarette product"}],"outcomes":[{"outcome_type":"primary","measure":"Change from Baseline Biomarkers of Tobacco Exposure in Urine to Day 5","time_frame":"5 days","description":"A comparison of biomarkers of tobacco exposure in urine from subjects at baseline and for 5 days after they have switched to one of the electronic cigarette products or abstinence.\r\nBiomarkers of tobacco exposure in urine include:\r\n4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) (NNAL) + glucuronides\r\nN'-nitrosonornicotine (NNN) + glucuronides\r\n4-aminobiphenyl\r\n1-aminonaphthalene\r\n2-aminonaphthalene\r\no-toluidine\r\nS-phenyl mercapturic acid (SPMA)\r\n3-hydroxy-1-methylpropyl-mercapturic acid (HMPMA)\r\n2-cyanoethyl mercapturic acid (CEMA)\r\nMonohydroxybutyl mercapturic acid (MHBMA)\r\n3-hydroxypropyl mercapturic acid (HPMA)\r\n3-hydroxy-benzo[a]pyrene"},{"outcome_type":"primary","measure":"Change from Baseline Biomarkers of Tobacco Exposure in Blood to Day 5","time_frame":"5 days","description":"A comparison of biomarkers of tobacco exposure in blood from subjects at baseline and for 5 days after they have switched to one of the electronic cigarette products or abstinence.\r\nBiomarkers of tobacco exposure in blood include:\r\n1. Carboxyhemoglobin"},{"outcome_type":"secondary","measure":"Change from Baseline Biomarkers of Tobacco Exposure in Urine to Day 5","time_frame":"5 days","description":"A comparison of biomarkers of tobacco exposure in urine from subjects at baseline and for 5 days after they have switched to one of the electronic cigarette products or abstinence.\r\nBiomarkers of tobacco exposure in urine include:\r\nUnconjugated nicotine\r\nUnconjugated cotinine\r\nUnconjugated trans-3'-hydroxycotinine\r\nNicotine-N-glucuronide\r\nCotinine-N-glucuronide\r\nTrans-3'-hydroxycotinine-O-glucuronide"},{"outcome_type":"secondary","measure":"Change from Baseline Biomarkers of Tobacco Exposure in Blood to Day 5","time_frame":"5 days","description":"A comparison of biomarkers of tobacco exposure in blood from subjects at baseline and for 5 days after they have switched to one of the electronic cigarette products or abstinence.\r\nBiomarkers of tobacco exposure in blood include:\r\nPlasma nicotine\r\nPlasma cotinine"}]}
{"nct_id":"NCT03157986","start_date":"2017-05-15","phase":"N/A","enrollment":48,"brief_title":"Effects of Whole-Body Vibration Training Versus Balance Training in Patients With Severe Chronic Obstructive Pulmonary Disease","official_title":"Effects of a Three Week Whole Body Vibration Training Versus Conventional Balance Training in Patients With Severe Chronic Obstructive Pulmonary Disease","primary_completion_date":"2019-08-16","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-08-16","last_update":"2019-12-24","description":"Aim of this study is to compare the effects of whole-body Vibration Training versus conventional Balance Training on Balance performance, gait quality and exercise capacity in patients with severe chronic obstructive pulmonary disease. Patients will be recruited during a 3-week inpatient pulmonary rehabilitation program and will be randomized into one of two intervention groups. On top of a standardized endurance and strength Training program (5 days per week) patients in both groups will perform an additional Balance Training (on 3 days per week). Patients in both Groups will perform the same 4 different Balance exercises (2x1 Minute each): dynamic squats with closed eyes, heel raise, semi-Tandem stance and single leg stance but on a different surface. The Vibration Training Group will perform the exercises on a side-alternating Vibration platform (Galileo) at frequencies between 15 to 26 Hertz and the control Group will perform exercises on instable objects like Balance pads. The degree of difficulty in both Groups will be individually adjusted and will be progressively increased, if possible.","other_id":"WBVT Balance Study","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":50,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  COPD stage III or IV according to the global initiative for chronic obstructive lung\r\n             disease\r\n\r\n          -  impaired exercise capacity (6 Minute walk distance of less than 70% of the reference\r\n             value from Troosters et al.)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  current acute exacerbation of COPD\r\n\r\n          -  carbon dioxide pressure of more than 45 mmHg at rest\r\n\r\n          -  any contraindication for vibration Training (e.g. acute deep vein thrombosis)\r\n      ","sponsor":"Schn Klinik Berchtesgadener Land","sponsor_type":"Other","conditions":"Chronic Obstructive Pulmonary Disease","interventions":[{"intervention_type":"Other","name":"Other: Balance Training on a vibration platform","description":"n=24 patients with severe chronic obstructive pulmonary disease. Exercises will be performed on a side-alternating Vibration platform (Galileo) at frequencies between 15 to 26 Hertz."},{"intervention_type":"Other","name":"Other: Conventional Balance training","description":"n=24 patients with COPD, Exercises will be performed on a Balance pad"}],"outcomes":[{"outcome_type":"secondary","measure":"Change in Balance Performance during 1-leg stance","time_frame":"measurement on Day 1 and 21","description":"patients stand still for 10 seconds with closed eyes on a force platform that measures absolute path length of the center of force."},{"outcome_type":"secondary","measure":"Change in 6-minute Walk Distance","time_frame":"measurement on Day 1 and 21","description":"patients are advised to walk as far as possible on a 30m track"},{"outcome_type":"secondary","measure":"Change in 4m Gait Speed Test","time_frame":"measurement on Day 1 and 21","description":"patients have to walk 4 meters at their usual Speed. Outcome is the average Speed during the 4m walk."},{"outcome_type":"secondary","measure":"Change in step symmetry during 20m walking","time_frame":"measurement on Day 1 and 21","description":"Patients walk 20m while wearing the Mc Roberts move test device (triaxial accelerometer) which performs a gait analysis"},{"outcome_type":"secondary","measure":"Change in Hospital anxiety and Depression scale","time_frame":"measurement on Day 1 and 21","description":"the Hospital anxiety and Depression scale is a questionnaire that evaluates signs of anxiety or depression"},{"outcome_type":"secondary","measure":"Change in balance performance during Romberg stance","time_frame":"measurement on Day 1 and 21","description":"patients stand still for 10 seconds with closed eyes on a force platform that measures absolute path length of the center of force."},{"outcome_type":"primary","measure":"Change in Balance Performance during semi Tandem stance","time_frame":"measurement on Day 1 and 21","description":"patients stand still for 10 seconds with closed eyes on a force platform that measures absolute path length of the center of force."},{"outcome_type":"secondary","measure":"Change in muscle power during counter movement jump","time_frame":"measurement on Day 1 and 21","description":"patients jump on a force platform as high as possible. The Outcome is Watt per Kilogram Body weight"},{"outcome_type":"secondary","measure":"Change in performance of the 5-Repetition-Raise-Test","time_frame":"measurement on Day 1 and 21","description":"Patients try to perform 5 repetitions of standing up and sitting down from a chair with crossed arms on a force platform as quick as possible"},{"outcome_type":"secondary","measure":"Change in performance of the 1-Minute-Chair-Rise-Test","time_frame":"measurement on Day 1 and 21","description":"Patients try to perform as many repetitions as possible of standing up and sitting down from a chair with crossed arms on a force platform during 1 minute"},{"outcome_type":"secondary","measure":"Change in Peak muscle strength of the knee Extension muscles","time_frame":"measurement on Day 1 and 21","description":"isometric peak torque of the knee extensor muscles are measured in 90° knee angle"},{"outcome_type":"secondary","measure":"Change in Peak muscle strength of the knee Flexion muscles","time_frame":"measurement on Day 1 and 21","description":"isometric peak torque of the knee flexor muscles are measured in 90° knee angle"}]}
{"nct_id":"NCT03634761","start_date":"2017-05-15","phase":"N/A","enrollment":17,"brief_title":"Early Intervention and Autism: Transformation From Research to Practice Through a Competency Based Model","official_title":"Early Intervention and Autism: Transformation From Research to Practice Through a Competency Based Model","primary_completion_date":"2019-05-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-05-30","last_update":"2019-09-20","description":"This study evaluates the effect of a competency based model on program quality in Swedish preschools for Children with autism spectrum disorder (ASD). Half of the participating preschools will receive \"treatment as usual\" (Early Intensive Behavioral Intervention (EIBI) provided to a Child with ASD in the preschool, supervised by an external supervisor from a habilitation center), while the other half will receive the above as well as, in-service training and monthly on-site coaching sessions also involving preschool staff other than the paraprofessional (competency based model). It is hypothesized that the competency based model will improve program quality, child's engagement, preschool staff knowledge, allegiance and self-efficacy compared to the comparison group.","other_id":"VR 2015-01212","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","intervention_model_description":"The study used a staggered design where three waves of preschools were recruited and assigned to either the experimental or the control group. The first wave of preschools (n = 6) were divided into two groups, where group assignment was made to make the two groups comparable in regards to three variables: supervisors' experience of comprehensive programs, APERS-P-SE baseline scores, and children's adaptive behavior (Vineland II ratings). Originally, the plan was to then randomize which of these two matched groups would be the experimental group, but because of unforeseen circumstances one of the groups was made the control group because there was a lack of resources for one of the preschools to be able to be in the experimental group. However, for the following two waves of recruitment, the participating preschools (n = 11) were divided into matched pairs (based only on supervisor experience), which were then randomly assigned either as the control or the experimental group.","sampling_method":"","gender":"All","minimum_age":2,"maximum_age":5,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Autism diagnosis\r\n\r\n          -  Receiving comprehensive program/EIBI implemented in preschool setting with supervision\r\n             from habilitation center\r\n\r\n        Exclusion Criteria:\r\n\r\n        -\r\n      ","sponsor":"Stockholm University","sponsor_type":"Other","conditions":"Autism Spectrum Disorder","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Competency based model","description":"Qualified Learning course and workshop to preschool staff combined with monthly on-site coaching at preschool sites to improve overall intervention setting quality and use of evidence bases practices, provided by external expert from habilitation center."},{"intervention_type":"Behavioral","name":"Behavioral: Comprehensive program","description":"Comprehensive program of EIBI for Children with ASD supervised by external expert from habilitation center (treatment as usual)"}],"outcomes":[{"outcome_type":"primary","measure":"Change in overall program quality measured by the Autism Program Environment Rating Scale (APERS-P-SE)","time_frame":"Baseline and follow-up (about 9 months from baseline)","description":"The APERS-P-SE is a rating scale designed to examine the preschool teaching environment of children with ASD in Sweden. It is used to assess overall intervention setting quality over 10 domains including areas such as Personal Independence and Functional Behavior. It consists of 56 items rated on a 5 Point Likert-scale (1= low quality - 5 = high quality) resulting in individual item scores, subdomain scores, domain scores and a total score."},{"outcome_type":"secondary","measure":"Ethics, Values and Allegiance (EVA)","time_frame":"Baseline and follow-up (about 9 months from baseline)","description":"A questionnaire used to assess attitude and allegiance to EIBI among preschool staff. 11 items/statements rated on a five point scale (I don't agree at all, to I highly agree)"},{"outcome_type":"secondary","measure":"Evidence Based Practices (EBP)","time_frame":"Baseline and follow-up (about 9 months from baseline)","description":"A questionnaire designed to assess knowledge, use and implementation skills of evidence based practices for Children with autism among preschool staff. 15 items rated on a 4 point Likert-scale (0 = no knowledge, 3 = high knowledge)"},{"outcome_type":"secondary","measure":"Autism Knowledge Questionnaire (AKQ)","time_frame":"Baseline and follow-up (about 9 months from baseline)","description":"A questionnaire designed to assess knowledge on ASD among preschool staff. 18 items/statements about autism, answered either yes/no/I dont know"},{"outcome_type":"secondary","measure":"Self-Efficacy and Stress Questionnaire (SESQ)","time_frame":"Baseline and follow-up (about 9 months from baseline)","description":"A questionnaire designed to assess stress and self-efficacy among preschool staff working with children with autism. A total of 34 items/statements rated on a 6 point Likert-scale (0 = i don't agree at all, 5 = i fully agree)"},{"outcome_type":"secondary","measure":"Goal Attainment Scale (GAS)","time_frame":"Follow-up about 9 months after onset of study","description":"An ordinal scale designed to assess level of goal attainment for participating Children in the study rated from 0 (baseline), 1 (initial objective), 2 (secondary objective), 3 (annual goal), 4 (exceeds annual goal)"},{"outcome_type":"secondary","measure":"Clinical Global Impression-autism (CGI-AUT)","time_frame":"Baseline and follow-up (about 9 months from baseline)","description":"An instrument designed to assess the symptom severity of preschool aged children with ASD rated on a scale between 1 and 7 (1 = no autism symptoms, 7 = maximum symptom severity)"},{"outcome_type":"secondary","measure":"Children's Engagement Questionnaire (CEQ)","time_frame":"Baseline and follow-up (about 9 months from baseline)","description":"A scale designed to assess children's level of engagement in various situations in and outside the preschool. It consists of 31 items/situations, rated on a 4 point scale (not at all typical, to very typical)"},{"outcome_type":"secondary","measure":"Vineland Adaptive Behavior Scales - Second Edition (Vineland-II) - Teacher ratings","time_frame":"Baseline and follow-up (about 9 months from baseline)","description":"A scale designed to assess the adaptive functioning for children within various domains such as independence and Communication skills. Rated on a 3 point scale (0 = never occurs, 2 = occurs often)"},{"outcome_type":"other","measure":"Social validity scale","time_frame":"Follow-up about 9 months after onset of study","description":"A scale designed to asses the social validity of the goals targeted within the study"}]}
{"nct_id":"NCT02959944","start_date":"2017-05-11","phase":"Phase 3","enrollment":193,"brief_title":"Ibrutinib in Combination With Corticosteroids vs Placebo in Combination With Corticosteroids in Participants With New Onset Chronic Graft Versus Host Disease (cGVHD)","official_title":"A Randomized, Double-Blind Phase 3 Study of Ibrutinib in Combination With Corticosteroids Versus Placebo in Combination With Corticosteroids in Subjects With New Onset Chronic Graft Versus Host Disease (cGVHD)","primary_completion_date":"2020-03-27","study_type":"Interventional","rec_status":"Completed","completion_date":"2021-06-16","last_update":"2021-06-22","description":"To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects with newly diagnosed moderate to severe cGVHD.","other_id":"PCYC-1140-IM","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":12,"population":"","criteria":"\n        Key Inclusion Criteria:\r\n\r\n          -  New onset moderate or severe cGVHD as defined by the 2014 National Institutes of\r\n             Health (NIH) Consensus Development Project Criteria\r\n\r\n          -  Need for systemic treatment with corticosteroids for cGVHD\r\n\r\n          -  No previous systemic treatment for cGVHD (including extracorporeal photopheresis\r\n             [ECP])\r\n\r\n          -  Participants may be receiving other immunosuppressants for the prophylaxis or\r\n             treatment of acute GVHD but if the subject is receiving prednisone for prophylaxis or\r\n             treatment of acute GVHD it must be at or below 0.5 mg/kg/d\r\n\r\n          -  Age 12 years old\r\n\r\n          -  Karnofsky or Lansky (subjects <16 years) performance status 60\r\n\r\n        Key Exclusion Criteria:\r\n\r\n          -  Received any previous systemic treatment for cGVHD with the exception of\r\n             corticosteroids administered for cGVHD within the 72 hours prior to signing the\r\n             informed consent form.\r\n\r\n          -  Inability to begin a prednisone dose 0.5 mg/kg/d for the treatment of cGVHD\r\n\r\n          -  Any uncontrolled infection or active infection requiring ongoing systemic treatment\r\n\r\n          -  Progressive underlying malignant disease or any post-transplant lymphoproliferative\r\n             disease\r\n\r\n          -  Known bleeding disorders\r\n\r\n          -  Active hepatitis C virus (HCV) or hepatitis B virus (HBV)\r\n      ","sponsor":"Pharmacyclics LLC.","sponsor_type":"Industry","conditions":"Chronic Graft Versus Host Disease","interventions":[{"intervention_type":"Drug","name":"Drug: ibrutinib","description":"Ibrutinib capsules administered orally daily"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo capsules administered orally daily"},{"intervention_type":"Drug","name":"Drug: Prednisone","description":"Prednisone administered daily"}],"outcomes":[{"outcome_type":"secondary","measure":"Percentage of Participants Who Achieved Reduction of Prednisone Dose Level to Less Than 0.15 mg/kg/Day at 24 Weeks Sustained for at Least 30 Days","time_frame":"24 weeks"},{"outcome_type":"primary","measure":"Response Rate at 48 Weeks","time_frame":"48 weeks","description":"Response rate was defined as the percentage of participants who were responders. Responders were defined as participants who had a complete response (CR) or a partial response (PR) at 48 weeks without starting any subsequent therapy for cGVHD or having evidence of relapse of their underlying disease that was indication for transplant prior to response assessment at 48 weeks.\r\nResponse was defined using the National Institutes of Health (NIH) Consensus Panel Chronic GVHD Activity Assessment (2014). Skin, mouth, liver, upper and lower gastrointestinal, esophagus, lung, eye, and joint/fascia are the organs or sites considered in evaluating overall response. CR is defined as resolution of all manifestations in each organ or site. PR is defined as improvement in at least 1 organ or site without progression in any other organ or site."},{"outcome_type":"secondary","measure":"Cumulative Incidence of Withdrawal of All Corticosteroids for Treatment of cGVHD","time_frame":"Months 3, 6, 9, 12, 15, 18, 21, 24","description":"The cumulative incidence of withdrawal of all corticosteroids (95% confidence interval [CI]) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy. Data presented are the estimated proportion of participants withdrawing all corticosteroids at given time point. The time to withdrawal of corticosteroids is computed from randomization date to the first date of withdrawal of all corticosteroids for treatment of cGVHD to 0 mg daily for at least 30 days."},{"outcome_type":"secondary","measure":"Cumulative Incidence of Withdrawal of All Immunosuppressants","time_frame":"Months 3, 6, 9, 12, 15, 18, 21, 24","description":"The cumulative incidence of withdrawal of all immunosuppressants (95% CI) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy. Data presented are the estimated proportion of participants withdrawing all immunosuppressants at a given time point. The time to withdrawal of all immunosuppressants is computed from randomization date to the first date of withdrawal of all immunosuppressants for treatment of cGVHD, sustained for at least 30 days. All immunosuppressants include corticosteroids but they do not include ibrutinib."},{"outcome_type":"secondary","measure":"Response Rate at 24 Weeks","time_frame":"24 weeks","description":"Response rate was defined as the percentage of participants who were responders. Responders were defined as participants who had a CR or PR at 24 weeks without starting any subsequent therapy for cGVHD or having evidence of relapse of their underlying disease that was indication for transplant prior to response assessment at 24 weeks.\r\nResponse was defined using the National Institutes of Health (NIH) Consensus Panel Chronic GVHD Activity Assessment (2014). Skin, mouth, liver, upper and lower gastrointestinal, esophagus, lung, eye, and joint/fascia are the organs or sites considered in evaluating overall response. CR is defined as resolution of all manifestations in each organ or site. PR is defined as improvement in at least 1 organ or site without progression in any other organ or site."},{"outcome_type":"secondary","measure":"Percentage of Participants With Improvement in Overall Score on Lee cGVHD Symptom Scale at Two Consecutive Visits","time_frame":"Assessed at Weeks 5, 13, 25, 37, 49, 30 days after the last dose of study drug, and then every 12 weeks of follow-up until progressed disease. Data cut-off was 30 March 2020.","description":"Clinically meaningful improvement on Lee cGVHD symptom scale was defined as at least a 7-point decrease in Lee Symptom Scale overall summary score on at least 2 consecutive visits, not preceded by progressive disease, relapse of underlying disease or start of subsequent cGVHD treatment.\r\nThe Lee cGVHD Symptom Scale score has 7 subscales (Skin, Eyes and Mouth, Breathing, Eating and Digestion, Muscles and Joints, Energy, and Mental and Emotional) with ratings as follows: 0- Not at all, 1- Slightly, 2 Moderately, 3 Quite a bit, 4-Extremely, with lower values representing a better outcome. A score is calculated for each subscale by taking the mean of all items completed if more than 50% were answered and normalizing to a 0 to 100 scale. An overall score is calculated as the average of these 7 subscales if at least 4 subscales have valid scores."},{"outcome_type":"secondary","measure":"Overall Survival (OS)","time_frame":"Median time on study as of data cut-off (30 March 2020) was 19.8 months and 18.4 months for the Ibrutinib + Prednisone and Placebo + Prednisone arms, respectively.","description":"OS was defined as the time of randomization until the time of death due to any cause, in months."},{"outcome_type":"secondary","measure":"Duration of Response (DOR) for Participants Who Had PR or CR at Any Time","time_frame":"Response was assessed every 4 weeks from Week 5 through Week 25, Week 37, Week 49, 30 days after the last dose of study drug, and then every 12 weeks of follow-up until progressed disease. Data cut-off was 30 March 2020.","description":"Response was defined using the NIH Consensus Panel Chronic GVHD Activity Assessment (2014). Skin, mouth, liver, upper and lower GI, esophagus, lung, eye, and joint/fascia are the organs or sites considered in evaluating overall response. CR was defined as resolution of all manifestations in each organ or site. PR was defined as improvement in at least 1 organ or site without progression in any other organ or site. Duration of response was estimated by Kaplan-Meier methodology."},{"outcome_type":"secondary","measure":"Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAE), and Discontinuations Due to AEs Placebo in Combination With Prednisone","time_frame":"From first dose of study drug through the end of treatment plus 30 days. As of data cutoff, (30 March 2020), median ibrutinib treatment duration was 5.4 months and the median placebo treatment duration was 6.4 months.","description":"AE: any untoward medical occurrence, which does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; is life-threatening; requires in-patient hospitalization >24 hours or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event. Severity was graded according to the Common Terminology Criteria for Adverse Events version 4.03 (grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening, grade 5=death). Treatment-related events are those that were possibly related or related to study treatment per investigator's judgment. Treatment emergent AEs (TEAEs) occurred from the first dose of study drug up to 30 days after the last dose of study drug."}]}
{"nct_id":"NCT02998892","start_date":"2017-05-09","phase":"N/A","enrollment":30,"brief_title":"Effects of Microbouts of Activity on Metabolic Health","official_title":"Effects of Microbouts of Activity on Metabolic Health","primary_completion_date":"2021-08-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-08-31","last_update":"2021-02-10","description":"Population studies suggest that time spent in sedentary behaviors is associated with all-cause mortality including obesity, diabetes, and cardiovascular diseases, independent of time spent in exercise. Frequent interruptions to sedentary time are however beneficially associated with metabolic health outcomes, even in individuals who exercise regularly. The goal is to use integrative approach to understand the biological mechanisms that underlie these associations in a longitudinal intervention study in overweight sedentary adults. The investigators believe that the proposed study will provide an initial evidence base for the health benefits of breaking up prolonged sitting with short bursts of activity. This innovative strategy may be more effective at combating the adverse effects of sedentary behaviors than more traditional approaches.","other_id":"16-1769","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Overweight but weight stable (+/- 3kg over previous 6 months) sedentary male and\r\n             female adults (n=30) will be recruited.\r\n\r\n          -  Ages between 18-45 years old\r\n\r\n          -  BMI of 25-35 kg/m2\r\n\r\n          -  Sedentary (< 1hr/wk of moderate-to-vigorous activity, less than 6,500 steps per day as\r\n             measured for 5 days in free-living conditions with a pedometer). Based on subjects\r\n             self-report during the H&P visit\r\n\r\n          -  The use of birth pill control will be accepted\r\n\r\n        Exclusion criteria:\r\n\r\n          -  Any history of renal (present or past kidney failure, kidney transplant, dialysis or\r\n             kidney cysts),\r\n\r\n          -  Uncontrolled hypertension\r\n\r\n          -  Cardiovascular (present or past atherosclerosis, heart attack, ischemic stroke, heart\r\n             failure)\r\n\r\n          -  Hepatic diseases (past or present hepatitis B or C, fibrosis, cirrhosis, NAFLD/NASH)\r\n\r\n          -  Type 1 or 2 diabetes\r\n\r\n          -  Cancer\r\n\r\n          -  Smoking\r\n\r\n          -  Consumption of drugs (marijuana included)\r\n\r\n          -  Consumption of alcohol (>40g/d)\r\n\r\n          -  HIV positivity\r\n\r\n          -  Psychiatric disorders\r\n\r\n          -  Any medications known to interfere with lipid or energy metabolism\r\n\r\n          -  Known physical activity contraindications\r\n\r\n          -  Major illness/physical problems (acute or chronic) that may limit their ability to\r\n             perform the walking activities\r\n\r\n          -  The blood draw will be used to objectively exclude peri- or postmenopausal women\r\n             (FSH>25 mlU/mL in early follicular phase)\r\n\r\n          -  Hypertriglyceridemia (triglycerides > 400mg/dL).\r\n      ","sponsor":"University of Colorado, Denver","sponsor_type":"Other","conditions":"Health Behavior","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Traditional Exercise Training","description":"Participants will be asked to perform moderate-intensity exercise (brisk walking) for 45 minutes for 5 days/week for 4 weeks. This intervention corresponds to the current recommendations."},{"intervention_type":"Behavioral","name":"Behavioral: Daily Microbursts of Activity","description":"Participants will be asked to break up their sedentary activities of daily living for 5-minutes every hour for 10 hours, 5 days/week, by brisk walking for 4 weeks."}],"outcomes":[{"outcome_type":"primary","measure":"Changes in sedentary time as measured by ActiPAL","time_frame":"weeks 1-2 and weeks 5-6","description":"Over each 2 week period, participants will be instructed to wear an ActiPAL (PALTechnologies: Glasgow, Scotland) activity monitor on their right leg. Participants will be instructed to wear the monitors at all times except when sleeping or participating in water-based activities. The time-stamped \"event\" data file from the activPAL software will be used to determine time spent sitting/lying, standing and stepping per day."},{"outcome_type":"primary","measure":"Changes in total substrate oxidation","time_frame":"week 2 and week 7","description":"Total fat oxidation during the test day will be determined using whole-room indirect calorimetry. O2 consumption and CO2 production will be determined from the flow rates and differences in gas concentrations between air entering and air exiting the calorimeter as previously described"},{"outcome_type":"primary","measure":"Changes in insulin sensitivity","time_frame":"week 2 and week 7","description":"Insulin sensitivity will be determined via an insulin modified frequently sampled intra-venous glucose tolerance test (IVGTT). After baseline samples, intravenous glucose (0.3 g/kg) will be infused over 1 minute, followed by insulin at 0.03 U/kg, 20 minutes after glucose administration. Blood samples will be frequently sampled over 5 hours, and insulin sensitivity will be calculated using the Bergman minimal model."},{"outcome_type":"secondary","measure":"Changes in total energy expenditure (TEE)","time_frame":"week 1-2 and week 5-6","description":"Total energy expenditure (TEE) will be measured before and at the end of the intervention using doubly labeled water (DLW) over a 10-day period, as previously described (31). Subjects will ingest premixed 2g/kg total body water (TBW), estimated as 73% of fat free mass) dose of DLW composed of 0.2 and 0.15 g/kg estimated TBW of H218O and 2H2O, respectively. Urine samples will be collected in duplicate on days 0, 6, 8 and 10. 2H and 18O enrichment will be determined in urine samples by isotope ratio mass spectrometry (Delta V Advantage IRMS)"},{"outcome_type":"secondary","measure":"Changes in Moderate-to-vigorous physical activity as measured by ActiGraph","time_frame":"weeks 1-6","description":"Over the same 10-day period, participants will be instructed to wear an Actigraph GT3X+ accelerometer (Actigraph, LLC, Fort Walton Beach, FL) on their hip. Participants will be instructed to wear the monitors at all times except when sleeping or participating in water-based activities."},{"outcome_type":"secondary","measure":"Changes in plasma CRP concentration","time_frame":"Once weekly for 5 weeks","description":"Weekly fasting blood samples will be obtained for the measurements of CRP (mg/dL)."},{"outcome_type":"secondary","measure":"Changes in Dietary Carbohydrate Oxidation","time_frame":"week 2 and week 7","description":"After the investigators have shown the subjects the procedure, subjects will collect their own hourly breath sampling for CO2 by blowing through a straw into two 15ml Vacutainers. Breath CO2 will be sampled directly from the Vacutainer with a syringe, and 13CO2 /12CO2 measured with IRMS."},{"outcome_type":"secondary","measure":"Changes in Dietary Fat Oxidation","time_frame":"week 2 and week 7","description":"Hourly urine sampling will be collected by the subjects for 24 hours and stored in 5mL cryovials at -20C until further analysis. To measure 2 hour fat oxidation, 2 hour/1 hour ratios from urine samples will be analyzed, as above described for the doubly labeled water method. The oxidation rate of glucose/water will be calculated from the cumulative recovery of 2 hours in total body water (TBW) as detailed previously."},{"outcome_type":"secondary","measure":"Changes in Mitochondria function","time_frame":"week 2 and week 7","description":"Freshly isolated skeletal muscle biopsies will be cut into small samples, the fibre bundles separated mechanically and partially teased apart and permeabilised. Small samples (2-5mg) will be added to the 2ml chamber of an Oroboros high-resolution respirometer with a mitochondrial respiration buffer. With the addition of several substrates, different states will be reached to analyse mitochondrial function. Pyruvate, malate and glutamate will be added as substrates to examine respiration through Complex I, succinate will be used to examine respiration through Complex II and octanoylcarnitine will be used to examine respiration through the electron-transferring flavoprotein, ETF."}]}
{"nct_id":"NCT03153228","start_date":"2017-05-08","enrollment":87,"brief_title":"Acute Response to Cigarette and E-cigarette Smoking Assesed in Exhaled Breath Condensate in Healthy Smokers of Traditional and E-cigarettes","official_title":"The Comparison of Biomarkers of Acute Response to Cigarette Smoking and E-cigarettes Smoking Assesed in Exhaled Breath Condensate in Healthy Smokers of Traditional and Electronical Cigarettes.","primary_completion_date":"2018-07-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2018-10-31","last_update":"2017-05-15","description":"Electronical cigarettes, also known as \"e-cigarettes\" are a new phenomenon, which steadily wins more aprobation among smokers. However, there exists no much data concerning the effects of acute exposure to electronic cigarettes vapour on the respiratory system. The aim of the present study is to evaluate and compare the acute response to electronic and traditional cigarettes in healthy smokers.","other_id":"IPU-DIMPA-WUM13(2)","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":90,"population":"Healthy smokers of traditional cigarettes, healthy smokers of e-cigarettes, healthy\r\n        nonsmoking volunteers","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  healthy smokers of traditional cigarettes - min. 1 packyear\r\n\r\n          -  healthy smokers of e-cigarettes - min. 1 year of smoking history\r\n\r\n          -  control group - healthy nonsmoking volunteers without any history of lung disease\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  age below 18 years\r\n\r\n          -  inhaled corticosteroid therapy at least 6 weeks prior to study enrollment\r\n\r\n          -  any co-morbidities\r\n\r\n          -  respiratory infections at least 6 weeks prior to study enrollment\r\n      ","sponsor":"Medical University of Warsaw","sponsor_type":"Other","conditions":"E-cigarettes","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Inflammatory markers in exhaled breath condensate","time_frame":"Approximately 1-2 months after completion of study procedures in all patients","description":"Inflammatory markers in exhaled breath condensate in healthy subjects, smokers of traditional cigarettes and e-cigarette smokers"}]}
{"nct_id":"NCT03268096","start_date":"2017-05-03","enrollment":298,"brief_title":"Disability, MRI Lesions and Thickness of Retinal Fibers: Evaluation 15 Years After a First Episode of Demyelination","official_title":"Disability, MRI Lesions and Thickness of Retinal Fibers: Evaluation 15 Years After a First Episode of Demyelination","primary_completion_date":"2021-12-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2022-01-31","last_update":"2021-07-14","description":"Knowledge of the evolution of multiple sclerosis (MS) and its long-term prognostic factors is essential to guide the therapeutic management. However, it remains partial and concerns above all data collected during the first years of the disease. The evolution towards disability can only be assessed after a follow-up of more than 10 years and does not depend solely on the initial inflammatory activity of the disease. We propose to realize a standardized clinical assessment, an optical coherence tomography (OCT) and a cerebral MRI 15 years after the first clinical manifestation of the disease. Clinical and paraclinical assessment will consist in the realization of additional MRI sequences in order to obtain more precise information on cerebral lesions (unconventional parameters). Optical coherence tomography (new generation device) will also be performed on both eyes to describe the thickness of the different layers of the retina. A clinical evaluation will be performed with the Expanded Disability Status Scale (EDSS). This study aims: 1. to describe the current clinical situation of patients (e.g. percentage of patients with moderate or severe disability) 2. to explore the associations between MRI parameters, those measured with OCT and clinical characteristics (disability) 3. to explore clinical and paraclinical prognostic factors of pejorative evolution (disability, severe cerebral atrophy, etc.)","other_id":"AGN_2017_6","observational_model":"Case-Only","time_perspective":"Cross-Sectional","sampling_method":"Probability Sample","gender":"All","population":"Patients who had an episode of demyelination at least 10 years ago","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  First episode of demyelination occurred at least 10 years ago\r\n\r\n          -  Hospitalized in the neurology department during this episode\r\n\r\n          -  Insured with a social security scheme\r\n\r\n          -  Having given his consent to participate in the study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Contraindications to 3 Tesla MRI and injection of contrast media\r\n\r\n          -  Benefiting from a legal protection measure\r\n\r\n          -  Pregnant or nursing mother\r\n      ","sponsor":"Fondation Ophtalmologique Adolphe de Rothschild","sponsor_type":"Other","conditions":"Multiple Sclerosis|Pathologic Processes|Tomography, Optical Coherence|Magnetic Resonance Imaging|Prognosis","interventions":[{"intervention_type":"Device","name":"Device: Cerebral MRI and Optical Coherence Tomography","description":"Clinical and paraclinical assessment (cerebral MRI and Optical Coherence Tomography) will be carried out on the same day. Paraclinical evaluation consists in the realization of additional MRI sequences in order to obtain more precise information on brain lesions (unconventional parameters). An optical coherence tomography will also be performed for both eyes to describe the thickness of the different layers of the retina."}],"outcomes":[{"outcome_type":"primary","measure":"Disability assessed with EDSS (Expanded Disability Status Scale)","time_frame":"Baseline","description":"Disability assessment will be carried out using the EDS (Expanded Disability Status) Scale.\r\nThis scale ranges from 0 to 10. Binary or ordered variables will be considered with various thresholds (for example, a score equal to 3 corresponds to moderate disorders ; a score equal to 6 corresponds to major disorders (need of a stick to walk 100 meters))."}]}
{"nct_id":"NCT03673995","start_date":"2017-05-02","phase":"N/A","enrollment":186,"brief_title":"Myoinositol Plus L-tyrosine, Selenium and Chromium in PCOS","official_title":"Use of Myoinositol Plus L-tyrosine, Selenium and Chromium in PCOS Women","primary_completion_date":"2018-08-22","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-10-30","last_update":"2020-06-16","description":"PCOS patients were treated every day, with one sachet containing 2000 mg myo-inositol, 500 mg L-tyrosine, 40 mcg chromium picolinate, 55 mcg selenium, 200 mcg folic acid. All patients underwent, before starting the therapy, after 3 months and 6 months, hormonal evaluation , hirsutism scoring and ovulation assesment. Most of them during the treatment improved their symptoms.","other_id":"PharmarteLtyrosine1","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":16,"maximum_age":38,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n         PCOS patients\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  thyroid dysfunction\r\n\r\n          -  hyperprolactinemia\r\n\r\n          -  adrenal hyperplasia\r\n\r\n          -  patients taking oral contraceptive\r\n\r\n          -  any other endocrinological pathologies\r\n      ","sponsor":"Pharmarte srl","sponsor_type":"Industry","conditions":"Polycystic Ovary Syndrome|Menstrual Problem|Hirsutism","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Myo-inositol+L-tyrosine","description":"PCOS patients were treated every day, with one sachet containing 2000 mg myo-inositol, 500 mg L-tyrosine, 40 mcg chromium picolinate, 55 mcg selenium, 200 mcg folic acid. All patients underwent, before starting the therapy, after 3 months and 6 months, hormonal, hirsutism and ovulation assesment."}],"outcomes":[{"outcome_type":"primary","measure":"Restore of regular menstrual period","time_frame":"6 months of treatment","description":"Self report"},{"outcome_type":"secondary","measure":"Improving hirsutism","time_frame":"6 months of treatment","description":"Standardised visual scales are preferred when assessing hirsutism, such as the modified Ferriman Gallwey score (mFG) with a level ≥ 4 - 6 indicating hirsutism,"},{"outcome_type":"secondary","measure":"Restore ovulation","time_frame":"6 months of treatment","description":"Progesterone value in luteal phase"}]}
{"nct_id":"NCT02696668","start_date":"2017-05-01","phase":"N/A","enrollment":100,"brief_title":"Advances in Group-based Falls Rehabilitation","official_title":"The Effect of a Modified FaME vs. a Multisensory Group Balance Programme on Falls Risk, Balance Confidence and Quality of Life in Older Adult Who Fall or Are at Risk of Falling","primary_completion_date":"2019-12-01","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2020-03-01","last_update":"2017-03-10","description":"This study's main aim is to compare the effect of a modified FaME vs. a multisensory balance exercise programme on falls risk, balance confidence and quality of life in older adults who fall or at risk of falling when implemented in a group setting.","other_id":"KingsCL","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Older adult 65 years old or older who have either experienced a fall or are at risk of\r\n        falling (Timed Up and Go score >15 seconds) and have been referred by the assessing\r\n        physiotherapist to a falls rehabilitation group class.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Older adults who have:\r\n\r\n             i) Cardiac syncope/pre-syncope ii) Postural hypotension iii) A Mini Mental State score\r\n             of <24/30. ii) Diagnosis of dementia or mild cognitive impairment ii) Acute illness\r\n             iii) Side effects of medication or drug intoxication iv) Evident musculo-skeletal or\r\n             neurological deficit that is likely to contribute to postural instability\r\n\r\n          2. Any individual with poor written/spoken English will not be included in the study due\r\n             to the need to complete multiple questionnaires.\r\n\r\n          3. Individuals with a known history of epilepsy in the last one year or currently\r\n             experiencing migraine will not be included in this study due to the use of optokinetic\r\n             stimuli.\r\n      ","sponsor":"King's College London","sponsor_type":"Other","conditions":"Accidental Falls","interventions":[{"intervention_type":"Other","name":"Other: modified FaME","description":"Group based exercise classes one hour weekly for 16 weeks. Each exercise class will have 8-10 participants and two instructors. The components of the FaME programme include specific falls management strategies, such as bone loading, gait, dynamic posture, balance, reaction and co-ordination training, functional floor activities to improve coping skills and confidence."},{"intervention_type":"Other","name":"Other: Multisensory","description":"Group based exercise classes one hour weekly for 16 weeks. Each exercise class will have 8-10 participants and two instructors.Participants will receive an initial assessment by the research physiotherapists to determine the most appropriate interventions for each participant. Interventions used will include:\r\nLimits of stability training with eyes open / eyes closed\r\nSelf induced movement strategies with eyes open / eyes closed\r\nGaze stability exercises in sitting / standing / walking\r\nSensory integration\r\nHabituation exercises"}],"outcomes":[{"outcome_type":"primary","measure":"Functional Gait Assessment","time_frame":"Baseline (prior to start of intervention), 8 weeks, 16 weeks and 32 weeks","description":"A 10-item test assesses complex gait tasks such as walking with head turns or stepping over an obstacle"},{"outcome_type":"secondary","measure":"Timed Up and Go test","time_frame":"Baseline (prior to start of intervention), 8 weeks, 16 weeks and 32 weeks","description":"A validated test of balance used to examine functional mobility."},{"outcome_type":"secondary","measure":"Mini Balance Evaluation Systems Test","time_frame":"Baseline (prior to start of intervention), 8 weeks, 16 weeks and 32 weeks","description":"A validated test designed to assess multiple aspects of postural control systems that may contribute to poor functional balance in adults"},{"outcome_type":"secondary","measure":"Activities-Specific Balance Confidence Scale","time_frame":"Baseline (prior to start of intervention), 8 weeks, 16 weeks and 32 weeks","description":"A validated self-report scale to assess balance confidence in daily activities"},{"outcome_type":"secondary","measure":"Falls Efficacy Scale - International","time_frame":"Baseline (prior to start of intervention), 8 weeks, 16 weeks and 32 weeks","description":"A validated self-report measure of fear of falling that assesses both easy and difficult physical and social activities"},{"outcome_type":"secondary","measure":"Environmental Analysis of Mobility Questionnaire","time_frame":"Baseline (prior to start of intervention), 8 weeks, 16 weeks, 32 weeks and one year","description":"A validated self-report scale to assess the relationship between characteristics of the physical environment and mobility disability"},{"outcome_type":"secondary","measure":"Hospital Anxiety and Depression Scale","time_frame":"Baseline (prior to start of intervention), 8 weeks, 16 weeks, 32 weeks and one year","description":"A self-report scale to assess anxiety and depression symptom."},{"outcome_type":"secondary","measure":"EQ-5D self-report questionnaire","time_frame":"Baseline (prior to start of intervention), 8 weeks, 16 weeks, 32 weeks and one year","description":"A standardised measure of health outcome."},{"outcome_type":"secondary","measure":"Vestibular Symptom Scale","time_frame":"Baseline (prior to start of intervention), 8 weeks, 16 weeks, 32 weeks and one year","description":"A validated self-report scale to assess common vestibular symptoms (i.e. giddiness) and autonomic/somatic anxiety symptoms."},{"outcome_type":"other","measure":"Cantab Dementia Battery","time_frame":"Baseline (prior to start of intervention), 8 weeks, 16 weeks and 32 weeks","description":"A validated computerized cognitive assessment system for measuring the severity of cognitive impairment in patients with prodromal Alzheimer's disease and those functioning within the dementia range"}]}
{"nct_id":"NCT03992833","start_date":"2017-05-01","phase":"N/A","enrollment":4000,"brief_title":"Methods of Computed Tomography Screening and Management of Lung Cancer","official_title":"Methods of Computed Tomography Screening and Management of Lung Cancer in Tianjin: A Population-based Cohort Study","primary_completion_date":"2020-05-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-09-30","last_update":"2019-06-20","description":"European lung cancer screening studies using computed tomography (CT) have shown that a management protocol based on measuring lung nodule volume and volume doubling time (VDT) is more specific for early lung cancer detection than a diameter-based protocol. However, whether this also applies to a Chinese population is unclear. The aim of this study is to compare the diagnostic performance of a volume-based protocol with a diameter-based protocol for lung cancer detection and optimize the nodule management criteria for a Chinese population.","other_id":"2016YFE0103000","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Screening","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":40,"maximum_age":74,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Aged 40-74 years;\r\n\r\n          -  Resident in the Hexi district of Tianjin city for at least 3 years;\r\n\r\n          -  Having no self-reported history of any malignant tumor.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnant woman will be excluded.\r\n      ","sponsor":"Tianjin Medical University Cancer Institute and Hospital","sponsor_type":"Other","conditions":"Lung Neoplasms|Computed Tomography|Mass Screening|Lung Nodules","interventions":[{"intervention_type":"Other","name":"Other: lung cancer screening","description":"In the first reading, according to the NCCN lung cancer screening guideline, participants with a solid nodule 5 mm in diameter will be referred to undergo follow-up CT 1 year after the baseline. Participants with a solid nodule 6-14 mm will be referred to undergo follow-up thorax CT 3-6 months after the baseline. Participants with a solid nodule  15 mm will be referred to a multidisciplinary team for clinical investigation.\r\nThe simulated management will be based on the volume of lung nodule and volume doubling time from the second reading, lung nodules will be reclassified according to the reference values from the European volume-based lung nodule management protocol. According to the European volume-based protocol, the solid and part-solid lung nodules will be reclassified into three groups: nodules with a volume < 100 mm3 (negative), nodules with a volume of 100-300 mm3 (indeterminate), and nodules with a volume > 300 mm3 (positive)."}],"outcomes":[{"outcome_type":"primary","measure":"number of clinically diagnosed lung cancer","time_frame":"at the fourth year from baseline","description":"The number of clinically diagnosed lung cancer will be collected through the hospital information system and by contacting the participants or their relatives using a questionnaire."},{"outcome_type":"primary","measure":"number of lung cancer death","time_frame":"at the fourth year from baseline","description":"The number of lung cancer death will be collected through the hospital information system and by contacting the relatives of the participants using a questionnaire."}]}
{"nct_id":"NCT03253770","start_date":"2017-05-01","phase":"N/A","enrollment":60,"brief_title":"Use of a Hand-held Digital Cognitive Aid in Simulated Cardiac Arrest.","official_title":"Use of a Hand-held Digital Cognitive Aid in Simulated Cardiac Arrest.","primary_completion_date":"2017-08-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-08-16","last_update":"2017-08-22","description":"Cardiac arrest is one of the most stressful situations to be managed. Our first study (MAX, accepted for publication BJA) clearly showed that it could not be compared to other urgent and stressful situations (malignant hyperthermia, anaphylactic shock, acute toxicity of local anesthetics, severe and symptomatic hyperkaliemia) whose management was significantly improved with the help of a digital cognitive aid. The present study exclusively deals with the management of cardiac arrest (recovery ward, or in the delivery room.) with the second generation of our digital cognitive aid, and explores new insights on how to better manage cardiac arrest with a digital cognitive aid in the hand of the leader.","other_id":"SIMMAX2","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Resident Physicians training in Anesthesia/Intensive care (same specialization in\r\n             France), year 1 to 5 (out of 5)\r\n\r\n          -  to be familiar with our simulation centre (at least passed once as a resident)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  no experience in simulation training\r\n      ","sponsor":"Claude Bernard University","sponsor_type":"Other","conditions":"Cardiac Arrest","interventions":[{"intervention_type":"Device","name":"Device: SIMMAX2","description":"Digital cognitive aid or paper cognitive aid during the management of a cardiac arrest in the recovery room or in the delivery room."}],"outcomes":[{"outcome_type":"primary","measure":"Technical Performance as compared to a Reference Task List","time_frame":"[ Time Frame: Time 0-30 min ]","description":"Number of tasks successfully performed, rated on remote video review"},{"outcome_type":"secondary","measure":"Non technical skills performance","time_frame":"[ Time Frame: Time 0-30 min ]","description":"As measured by the Ottawa score, rated on remote video review"}]}
{"nct_id":"NCT03122327","start_date":"2017-05-01","enrollment":200,"brief_title":"cGA in Newly-diagnosed Elderly MM Patients: a Multi-center, Prospective, Non-interventional Study.","official_title":"Comprehensive Geriatric Assessment (cGA) in Newly-diagnosed Elderly Multiple Myeloma (MM) Patients: a Multi-center, Prospective, Non-interventional Study.","primary_completion_date":"2020-05-01","study_type":"Observational","rec_status":"Not yet recruiting","completion_date":"2022-05-01","last_update":"2017-04-25","description":"This is a multi-center, prospective, non-interventional study. Eligible newly diagnosed elderly multiple myeloma (MM) patients will receive comprehensive geriatric assessment (cGA) including ECOG scale, questionaires of ADLactivities of daily living), IADL(instrumental ADL),MNA-SF(mini-nutritional assessment), GDS(geriatric depression scale), MMSE(mini-mental state examination), SF-36 and CCI (charlson comorbidity index). Patients will get standard care for MM and receive the above assessments at baseline and after cycle 1, 4 and 12 for treating MM.Follow-up information and survival data of these MM patients would be collected. We would evaluate the cGA status of these newly diagnosed elderly MM patients and investigate the association of cGA parameters with patient's survival.","other_id":"S-K230","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":65,"population":"Newly diagnosed Multiple myeloma (MM) patients>=65 years old","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  age>=65 years old;\r\n\r\n          -  newly diagnosed and untreated MM patients;\r\n\r\n          -  able to provide informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  refused to participate;\r\n\r\n          -  with concomitant amyloidosis;\r\n\r\n          -  smoldering MM.\r\n      ","sponsor":"Peking Union Medical College Hospital","sponsor_type":"Other","conditions":"Multiple Myeloma|Comprehensive Geriatric Assessment","interventions":[{"intervention_type":"Other","name":"Other: Questionaires","description":"Questionaires of cGA assessment. No other interventions would be carried out aside from the standard treatment for MM."}],"outcomes":[{"outcome_type":"primary","measure":"Current status of cGA in newly diagnosed elderly MM patients","time_frame":"12 cycles of MM treatment (about 12 months) after the last patient begins treatment","description":"Description of the cGA (comprehensive geriatric assessment) status of the target population which is currently not known in China. The cGA parameters to be described include baseline ECOG, ADL（activities of daily living), IADL(instrumental ADL),MNA-SF(mini-nutritional assessment), GDS(geriatric depression scale), MMSE(mini-mental state examination), SF-36 and CCI (charlson comorbidity index) which would be carried out by trained physicians. The physicians would receive standard training from geriatricians of Peking Union Medical College Hospital. Moreover, as the treatment for MM (multiple myeloma) patients continues, re-evaluation of the cGA parameters would be done. The status of ECOG, ADL, IADL, GDS, SF-36 would be re-evaluated after cycle 1, 4, 12 of MM treatment. And MNA-SF scale would be re-assessed after cycle 4 and 12 of MM treatment. A description of the changes of the above scales would also be recorded for these MM patients."},{"outcome_type":"secondary","measure":"Association between the baseline cGA parameters and patients' overall survival","time_frame":"5 years after the last patient begins treatment for MM","description":"To evaluate the association of the baseline cGA parameters (including ECOG, ADL, IADL,MNA-SF, GDS, MMSE, SF-36 and CCI ) and patient's overall survival"},{"outcome_type":"secondary","measure":"Association between baseline cGA parameters and patients' progression free survival","time_frame":"5 years after the last patient begins treatment for MM","description":"To evaluate the association of cGA parameters (including ECOG, ADL, IADL,MNA-SF, GDS, MMSE, SF-36 and CCI ) and patient's progression free survival"}]}
{"nct_id":"NCT02907632","start_date":"2017-04-26","phase":"Phase 4","enrollment":490,"brief_title":"Methoclopramide for Gastroesophageal Reflux in Premature Infants","official_title":"Use of Metoclopramide for the Prevention of Gastroesophageal Reflux in Premature Infants Followed in an Outpatient Kangaroo Mother Care Clinic Before 40 Weeks of Gestational Age: A Randomized Controlled Trial","primary_completion_date":"2019-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-01-31","last_update":"2020-09-02","description":"Gastroesophageal Reflux (GER) is a condition that affects the majority of premature infants that are followed at the Kangaroo Mother Care Program (ambulatory program for preterm infants discharged with their mothers in continuous skin to skin contact and strict outpatient follow up). For over 20 years, the use of Metoclopramide has been systematic among all preterm infants according to the protocols of the Kangaroo Mother Care (KMC) Program . The aim of this clinical trial is to evaluate the effectiveness and security of metoclopramide to lessen the symptoms of GRE in premature infants that are followed and treated in the Ambulatory KMC Program before 40 weeks of gestational age. Design: Randomized, double blind trial, controlled with placebo. Eligible Population: Premature infants that are followed and treated in the Ambulatory Kangaroo Mother Care Program at Hospital Universitario San Ignacio before 40 weeks of gestational age, which systematically receive: metoclopramide 0.2 mg per kg, every 8 hours, 15 minutes before every feeding up to 40 weeks of gestational age, between January 01 2017 and December 31 2017.Outcomes: Incidence of regurgitation episodes reported by the parents of the infants, episodes of apnea, bronchoaspiration, postprandial irritability, the infant rejects feeding, alteration in the postprandial posture and the frequency and severity of adverse effects associated with the use of Metoclopramide such as extrapyramidal symptoms and sedation. In the case of continuous variables, the mean and median will be compared according to the distribution and for nominal variables, a chi squared test or fisher test will be carried out. Duration: 12 months. Ethical Aspects: Experiment with minimum mayor risk. Informed consent will be requested to parents. An independent committee from the work group will be in charge of carrying out the follow-up of the safety and progression of the study. A methodological expert, a thematic expert, a statistician and an expert in bioethics will constitute the committee. Financial Disclosure: The study will be funded through the Kangaroo Foundation with the collaboration of the \" Hospital Universitario San Ignacio\", Bogot, Colombia.","other_id":"2015/71","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","maximum_age":0.27397,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Preterm infants followed at ambulatory Kangaroo Mother Care Program(KMCP) in Hospital San\r\n        Ignacio, Bogot, Colombia.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Hipoxic- Ischemic Encephalopathy. Periventricular Leukomalacia (PVL). Intraventricular\r\n        hemorrhage grade 3 or 4. Severe dystonia Seizures. Liver failure. Renal insufficiency.\r\n        Previous adverse events with the use of Metoclopramide. Parents dont agree participation.\r\n      ","sponsor":"Nathalie Charpak","sponsor_type":"Other","conditions":"Gastroesophageal Reflux","interventions":[{"intervention_type":"Drug","name":"Drug: Metoclopramide","description":"Metoclopramide Solution 4 mg / ml; 30 ml canister (1 drop equals 0.2 mg). Dose: 0.2 mg / kg / dose (1 drop per kg) every 8 hours orally 15 minutes before lactation.\r\nDuration: Until the child completes 40 weeks of post menstrual age."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Oral solution: 1 drop per kg of placebo 15 minutes before lactation with identical presentation appearance, taste and color than Metoclopramide. Duration: Until the child completes 40 weeks of post menstrual age."}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of regurgitation episodes","time_frame":"Until 40 weeks Post Menstrual Age","description":"Reported by the parents of the infants in a diary."},{"outcome_type":"secondary","measure":"Episodes of apnea","time_frame":"Until 40 weeks Post Menstrual Age","description":"Reported in clinical history"},{"outcome_type":"secondary","measure":"Bronchoaspiration","time_frame":"Until 40 weeks Post Menstrual Age","description":"Reported in clinical history"},{"outcome_type":"secondary","measure":"Postprandial irritability","time_frame":"Until 40 weeks Post Menstrual Age","description":"Reported by the parents of the infants in a diary"},{"outcome_type":"secondary","measure":"The infant rejects feeding","time_frame":"Until 40 weeks Post Menstrual Age","description":"Reported by the parents of the infants in a diary"},{"outcome_type":"secondary","measure":"Alteration in the postprandial posture","time_frame":"Until 40 weeks Post Menstrual Age","description":"Reported by the parents of the infants in a diary"},{"outcome_type":"other","measure":"extrapyramidal symptoms","time_frame":"Until 40 weeks Post Menstrual Age","description":"Reported in clinical history"}]}
{"nct_id":"NCT03191162","start_date":"2017-04-21","phase":"Phase 2","enrollment":240,"brief_title":"Evaluation of Different Benznidazole Regimens for the Treatment of Chronic Chagas Disease.","official_title":"Phase II Clinical Trial for the Evaluation of Different Benznidazole Regimens for the Treatment of Chronic Chagas Disease in Adult Patients. Berenice Project","primary_completion_date":"2018-04-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2018-09-30","last_update":"2017-06-19","description":"A phase 2 clinical trial to evaluate the the efficacy of different benznidazole regimens (300mg/day for 60 days, 150mg/day for 60 days, and 400mg/day for 15 days) for the treatment of chronic Chagas disease in adult patients. The efficacy is assessed through the proportion of patients with negative parasitaemia measured by Polymerase Chain Reaction (PCR) during the first 12 months after starting treatment. The study will be performed in Spain, Brazil, Argentina and Colombia.","other_id":"2016-003789-21","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Over 18 years old.\r\n\r\n          -  Diagnosis of Chagas disease through two different serological tests.\r\n\r\n          -  Positive T. cruzi PCR in peripheral blood.\r\n\r\n          -  Signed informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Previous treatment with Benznidazole or Nifurtimox.\r\n\r\n          -  Alcohol consumption.\r\n\r\n          -  Acute or chronic health problems that could interfere in the assessment of the\r\n             efficacy or safety of the drug (acute infections, HIV infection, liver or renal\r\n             impairment, etc).\r\n\r\n          -  Nitroimidazole hipersensitivity.\r\n\r\n          -  Concomitant or previous treatment with allopurinol or antifungal drugs.\r\n\r\n          -  Pregnancy.\r\n      ","sponsor":"Hospital Universitari Vall d'Hebron Research Institute","sponsor_type":"Other","conditions":"Chagas Disease|Trypanosoma Cruzi Infection","interventions":[{"intervention_type":"Drug","name":"Drug: Benznidazole","description":"To evaluate different regimens of Benznidazole for the treatment of chronic Chagas disease"}],"outcomes":[{"outcome_type":"primary","measure":"Proportion of patients with negative parasitaemia measured by PCR during the first 12 months after starting treatment","time_frame":"12 months","description":"The treatment efficacy is assessed through the proportion of patients with negative parasitaemia measured by PCR during the first 12 months after starting treatment"}]}
{"nct_id":"NCT03148600","start_date":"2017-04-20","phase":"N/A","enrollment":60,"brief_title":"Rehabilitation After Ileo-anal Pouch Surgery","official_title":"Behavioural Treatment Following Ileo-Anal Pouch Formation:","primary_completion_date":"2022-06-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-12-31","last_update":"2021-03-19","description":"Multi-centre, assessor-blinded, randomised controlled trial comparing physiotherapist-led behavioural intervention (including pelvic floor muscle training) to standard care, in the management of post-operative ileo-anal pouch patients.","other_id":"HREC/16/SVHM/214","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Proven (documented) history of Ulcerative Colitis or Familial Adenomatous Polyposis\r\n\r\n          -  Proctocolectomy and awaiting ileo-anal pouch formation or have had ileo-anal pouch\r\n             created and are waiting for stoma reversal or have had stoma reversal within the last\r\n             60 days\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Primary sclerosing cholangitis\r\n\r\n          -  Significant medical or psychiatric comorbidity that in the opinion of the\r\n             investigators would interfere with bowel function or adherence to the protocol\r\n\r\n          -  Clinically significant narcotic or substance abuse that in the opinion of the\r\n             investigators would interfere with bowel function or adherence to the protocol\r\n\r\n          -  Recognised eating disorder\r\n\r\n          -  Non- English speaking or illiterate\r\n\r\n          -  Pregnancy\r\n\r\n          -  Current participant in another trial\r\n      ","sponsor":"St Vincent's Hospital Melbourne","sponsor_type":"Other","conditions":"Colonic Pouches|Physical Therapy Modalities|Biofeedback","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Pelvic floor and bowel behavioural training","description":"Physiotherapist-led pelvic floor muscle and bowel behavioural training"},{"intervention_type":"Other","name":"Other: Standard arm","description":"Standard medical and nursing care"}],"outcomes":[{"outcome_type":"primary","measure":"Colo Rectal Functional Outcome Score (COREFO)","time_frame":"6 and 12 months following ileostomy reversal","description":"Between group comparison of outcome score - total and each of 5 domains"},{"outcome_type":"secondary","measure":"Pouch Dysfunction score","time_frame":"1,3,6 and 12 months following ileostomy closure","description":"Comparison of scores between groups"},{"outcome_type":"secondary","measure":"Quality of Life Short-Form 36 (SF-36)","time_frame":"Baseline, 3,6 and 12 months following ileostomy closure","description":"Quality of life SF-36 compared between groups - mental health domain, physical health domain and total score"},{"outcome_type":"secondary","measure":"Quality of Life EQ-5D","time_frame":"Baseline,3,6 and 12 months following ileostomy closure","description":"Scores from the EQ-5D will be compared between groups and quality adjusted life years (QALY) will be derived from EQ-5D."},{"outcome_type":"secondary","measure":"Inflammatory Bowel Disease Questionnaire (IBDQ)","time_frame":"Baseline,3,6 and 12 months following ileostomy closure","description":"Disease specific quality of life score comparing groups"},{"outcome_type":"secondary","measure":"Hospital Anxiety and Depression Scale (HADs)","time_frame":"Baseline,3,6 and 12 months following ileostomy closure","description":"Psychological well being scores for anxiety and depression comparing groups"},{"outcome_type":"secondary","measure":"Brief Illness Perception Questionnaire","time_frame":"Baseline,3,6 and 12 months following ileostomy closure","description":"Between group comparison of cognitive and emotional perceptions of illness"},{"outcome_type":"secondary","measure":"Brief Cope","time_frame":"Baseline,3,6 and 12 months following ileostomy closure","description":"Between group comparison of coping styles and ability to cope with stress"},{"outcome_type":"secondary","measure":"New General Self-Efficacy Scale","time_frame":"Baseline,3,6 and 12 months following ileostomy closure","description":"Between group comparison of confidence in ability to perform tasks and achieve goals"},{"outcome_type":"other","measure":"Patient Global Impression of Improvement and Satisfaction","time_frame":"3,6 and 12 months following ileostomy closure","description":"Between group comparison of patient rating of improvement and satisfaction on 7-point Likert Scales"},{"outcome_type":"other","measure":"Adherence","time_frame":"1,2,3,4,5 and 6 months following ileostomy closure","description":"Patient rating of their level of adherence to the training programme"},{"outcome_type":"other","measure":"Pelvic floor muscle function","time_frame":"Baseline and 6 months following ileostomy closure","description":"Transperineal measurements of displacement of puborectalis and change in anorectal angle with pelvic floor muscle contraction and with simulated defaecation"},{"outcome_type":"other","measure":"Cost to the healthcare system","time_frame":"Baseline, 6 and 12 months following ileostomy closure","description":"Compare health care utilisation between groups"}]}
{"nct_id":"NCT02980692","start_date":"2017-04-19","phase":"Phase 2","enrollment":391,"brief_title":"Efficacy and Safety Study of SUNPG1623","official_title":"A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Phase 2b Study to Demonstrate the Safety and Efficacy of Tildrakizumab in Subjects With Active Psoriatic Arthritis","primary_completion_date":"2019-03-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-09-24","last_update":"2021-05-19","description":"This is a randomized, double-blind, placebo-controlled, multiple-dose, phase 2b study to demonstrate the safety and efficacy of SUNPG1623","other_id":"CLR_16_23","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subject has provided written informed consent\r\n\r\n          -  Subject is  18 years of age at time of Screening\r\n\r\n          -  Subject must be on stable dose of NSAID for  4 weeks prior to initiation of IMP\r\n\r\n          -  Subject has a negative evaluation for TB within 4 weeks before initiating IMP\r\n\r\n          -  Subject has a diagnosis of PsA (by the Classification of Psoriatic Arthritis [CASPAR]\r\n             criteria) with symptoms present for at least 6 months.\r\n\r\n          -  Subject has  3 tender and  3 swollen joints at Screening and Baseline.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subject has a planned surgical intervention between Baseline and the Week 24\r\n             evaluation for a pretreatment condition\r\n\r\n          -  Subject has an active infection or history of infections\r\n\r\n          -  Subject has any concurrent medical condition or uncontrolled, clinically significant\r\n             systemic disease\r\n\r\n          -  Subject has a known history of infection with hepatitis B, hepatitis C, or human\r\n             immunodeficiency virus\r\n      ","sponsor":"Sun Pharma Global FZE","sponsor_type":"Industry","conditions":"Active Psoriatic Arthritis","interventions":[{"intervention_type":"Drug","name":"Drug: SUNPG1623 I","description":"injection"},{"intervention_type":"Drug","name":"Drug: SUNPG1623 II","description":"injection"},{"intervention_type":"Drug","name":"Drug: SUNPG1623 III","description":"injection"},{"intervention_type":"Drug","name":"Drug: SUNPG1623 IV","description":"injection"},{"intervention_type":"Drug","name":"Drug: PLACEBO","description":"injection"}],"outcomes":[{"outcome_type":"primary","measure":"Proportion of Subjects Who Achieve American College of Rheumatology20 Response Rate","time_frame":"week 1, week 4, week 8, week 12, week 16, week 20 and week 24","description":"The American College of Rheumatology20 response measured the percentage of subjects with at least a 20% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein."},{"outcome_type":"secondary","measure":"Proportion of Subjects Achieving American College of Rheumatology50 Response Rate","time_frame":"week 1, week 4, week 8, week 12, week 16, week 20, and week 24","description":"The American College of Rheumatology50 response measured the percentage of subjects with at least a 50% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein."},{"outcome_type":"secondary","measure":"Proportion of Subjects Achieving American College of Rheumatology70 Response Rate","time_frame":"week 1, week 4, week 8, week 12, week 16, week 20, and week 24","description":"The American College of Rheumatology70 response measured the percentage of subjects with at least a 50% improvement from Baseline in both tender joints (68) and swollen joints (66) and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein."},{"outcome_type":"secondary","measure":"Change From Baseline in Tender Joint Counts","time_frame":"week 1, week 4, week 8, week 12, week 16, week 20, and week 24","description":"Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis."},{"outcome_type":"secondary","measure":"Change From Baseline in Swollen Joint Counts","time_frame":"week 1, week 4, week 8, week 12, week 16, week 20, and week 24","description":"Peripheral joints were assessed for tenderness and swelling. There is no validated measure to assess peripheral joints in Psoriatic arthritis; the measure used was the American College of Rheumatology joint count initially developed for the assessment of patients with rheumatoid arthritis."},{"outcome_type":"secondary","measure":"Physician Global Assessment of Disease Activity Visual Analog Scale","time_frame":"week 1, week 4, week 8, week 12, week 16, week 20, and week 24","description":"100 mm Visual analog scale with descriptors (verbal) : \"very good\" (0) to \"very poor\" (100)"},{"outcome_type":"secondary","measure":"Patient's Global Assessment of Disease Activity","time_frame":"week 1, week 4, week 8, week 12, week 16, week 20 and week 24","description":"100 mm Visual analog scale descriptors (verbal) : \"very well\" (0) to \"very poorly\"(100)"},{"outcome_type":"secondary","measure":"Patient's Pain Assessment","time_frame":"week 1, week 4, week 8, week 12, week 16, week 20, and week 24","description":"100 mm Visual Analog Scale with scale (verbal descriptors) \"no pain\" (0) to \"worst possible pain\" (100)."},{"outcome_type":"secondary","measure":"Health Assessment Questionnaire- Disability Index","time_frame":"week 1, week 4, week 8, week 12, week 16, week 20, and week 24","description":"eight categories assessed by the Health Assessment Questionnaire - Disability Index 1) dressing and grooming, 2) arising, 3) eating, 4) walking, 5) hygiene, 6) reach, 7) grip and 8) common daily activities was scored as 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) or 3 (unable to do).\r\nThe score for the disability index is the mean of the 8 category scores. If more than 2 of the categories, or 25%, are missing, the scale is not scored. If fewer than 2 of the categories are missing, the sum of the categories is divided by the number of answered categories. A higher score indicates greater disability"},{"outcome_type":"secondary","measure":"Acute Phase C - Reactive Protein","time_frame":"week 1, week 4, week 8, week 12, week 16, week 20, and week 24","description":"C-reactive protein (CRP) is a blood test marker for inflammation in the body. CRP is produced in the liver and its level is measured by testing the blood.\r\nCRP is classified as an acute phase reactant, which means that its levels will rise in response to inflammation"},{"outcome_type":"secondary","measure":"Erythrocyte Sedimentation Rate","time_frame":"week 1, week 4, week 8, week 12, week 16, week 20, and week 24","description":"An erythrocyte sedimentation rate (ESR) is a type of blood test that measures how quickly erythrocytes (red blood cells) settle at the bottom of a test tube that contains a blood sample. This test help determine if you have a condition that causes inflammation."},{"outcome_type":"secondary","measure":"The Proportion of Subjects Who Require Adjustment of Background Therapy","time_frame":"Week 16"},{"outcome_type":"secondary","measure":"Disease Activity Score (DAS) 28 (Joints) C - Reactive Protein (DAS28-CRP) Response Rate","time_frame":"week 1, week 4, week 8, week 12, week 16, week 20, and week 24","description":"The Disease Activity Score 28-item C-Reactive Protein: assessed across 28 joints including the shoulder, elbow, wrist, MCP (1 through 5), PIP (1 through 5) and knee, with all 14 joints assessed for each side of the body. It is a composite score derived from examination of the 28 joints for swelling and tenderness, global assessment of pain and overall status using a VAS and a blood marker of inflammation (hsCRP).\r\nDAS28-CRP(4) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*GH + 0.96 TJC- tender joint count, SJC- swollen joint count, CRP- C reactive protein, GH - patient global health"},{"outcome_type":"secondary","measure":"Minimal Disease Activity","time_frame":"week 1, week 4, week 8, week 12, week 16, week 20, and week 24","description":"A psoriatic arthritis patient is defined as having a Minimal Disease Activity (MDA) response (Yes/No) when the patient meets at least 5 of the 7 following criteria:\r\ntender joint count ≤1;\r\nswollen joint count ≤1;\r\nPASI score ≤1 or BSA ≤3%;\r\npatient Arthritis Pain (VAS)\r\n≤15 mm;\r\npatient's global arthritis assessment (VAS) ≤20 mm;\r\nHAQ-DI score ≤0.5;\r\ntender entheseal points (using LEI) ≤1."},{"outcome_type":"secondary","measure":"Change From Baseline in Leeds Dactylitis Index (LDI)","time_frame":"week 4, week 12, and week 24","description":"tenderness score (0 = no tenderness, 1 = tender, 2 = tender and wince, and 3 = tender and withdraw)\r\nTotal score= {[Circumference involved digit/ Circumference contralateral Digit (or Tables)] - 1x 100}x Tenderness score\r\nStandard reference: Hands Digit Men Women Thumb 70 58 Index 63 54 Middle 63 54 Ring 59 50 Little 52 44 Standard reference: Feet Digit Men Women Great Toe 82 72 Second 52 46 Middle 50 44 Fourth 50 44 Little 52 45\r\nThe difference between circumference of affected finger and contralateral not affected digit cannot be defined for maximum value. Therefore, it is difficult to provide scale range for the final score. No theoretical range exists for the Leeds Dactylitis Index.\r\nLower Leeds Dactylitis Index score represent better outcome."},{"outcome_type":"secondary","measure":"Change From Baseline in Leeds Enthesitis Index (LEI)","time_frame":"week 4, week 12 and week 24","description":"The LEI examines tenderness at 6 sites:\r\n2 sites (left and right) at each of the lateral epicondyles of the humerus, medial condyles of the femur and the insertion of the Achilles tendon. For each entheseal site, assessment is made of the adjacent joint in terms of tenderness and soft-tissue swelling, with a score of 1 if present. The LEI score range is 0-6.\r\nLower the score better is the outcome"}]}
{"nct_id":"NCT03081403","start_date":"2017-04-14","phase":"N/A","enrollment":42,"brief_title":"Quantitative Sensory Testing in Subjects With Sensitive Skin or Not","official_title":"Quantitative Sensory Testing in Subjects With Sensitive Skin or Not","primary_completion_date":"2017-09-22","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-10-17","last_update":"2017-10-19","description":"Sensitive skin is a common problem, with 50% of women and 30% of men in Europe feel they have sensitive skin. The Quantitative sensory testing (QST) is a physico-psychic method that uses gradients stimuli of different modalities to measure a subjective somatosensory response. This allows to characterize sensory dysfunction by assessing the participation of small and large nerve fibers. The aim of this project is to characterize the presence or absence of a neurological disorder in patients with sensitive skin. This discovery would be a decisive argument to reinforce the suspicion that sensitive skins is linked to a small fiber neuropathy.","other_id":"SENSISKIN 29CRB16.0100","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age: between 20 and 60 years\r\n\r\n          -  Cooperating patient\r\n\r\n          -  Informed and written consent of the subject\r\n\r\n          -  Affiliated to the social security\r\n\r\n          -  For subjects with sensitive skin:\r\n\r\n        subjects with a score greater than 50 on the scale sensitive scale\r\n\r\n        - To control subjects: subjects with result of less than 20 sensitive to the scale scale\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Adults subject with legal protection\r\n\r\n          -  Subject in a social institution.\r\n\r\n          -  Subject with major cognitive or psychiatric disorders\r\n\r\n          -  Subject with pathological use of alcohol or consumption of another drug.\r\n\r\n          -  Subject with skin involvement of the back of the dominant hand or malformation.\r\n\r\n          -  Known sensitive neuropathy\r\n\r\n          -  Pregnant woman\r\n\r\n          -  Subject receiving medical treatment which may interfere with the results.\r\n\r\n          -  Subject with treatment in the back of the dominant hand.\r\n      ","sponsor":"University Hospital, Brest","sponsor_type":"Other","conditions":"Sensitive Skin","interventions":[{"intervention_type":"Device","name":"Device: Quantitative Sensory Testing","description":"Study of detection thresholds of vibration, cold and pain related to the heat in the dominant hand of the subjects through the QST."}],"outcomes":[{"outcome_type":"primary","measure":"Cutaneous perception threshold","time_frame":"6 months","description":"The cutaneous perception threshold of pain to heat."},{"outcome_type":"secondary","measure":"The cutaneous perception threshold of vibration","time_frame":"6 months","description":"The cutaneous perception threshold of pain to harm."},{"outcome_type":"secondary","measure":"The cutaneous perception threshold of cold","time_frame":"6 months","description":"The cutaneous perception threshold of cold"}]}
{"nct_id":"NCT03163199","start_date":"2017-04-12","enrollment":22,"brief_title":"TRanslesIonal Assessment of Gradients During Endovascular Therapy","official_title":"TRanslesIonal Assessment of Gradients During Endovascular Therapy","primary_completion_date":"2019-03-01","study_type":"Observational","rec_status":"Active, not recruiting","completion_date":"2021-10-31","last_update":"2021-07-07","description":"Primary objective: To document change in translesional pressure gradients (TLPGs) and ratios (fractional flow reserve) using the NAVVUS RXi catheter following endovascular treatment for symptomatic lower extremity peripheral arterial disease. Secondary objectives: - Evaluation of correlation of the ABI and TBI and TLPGs at baseline and following endovascular therapy - Evaluation of the correlation between the change in WIQ, TCOMs, wound size and change in TLPGS - Evaluation of correlation between lesion severity by QVA (MLD, % diameter stenosis) and TLPGs - Evaluation of baseline MLA, MLD, plaque burden by intravascular ultrasound (optional) and TLPGs","other_id":"CTMS 14-0147-001","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Adults with symptomatic peripheral arterial disease (critical limb ischemia or\r\n        claudication)","criteria":"\n        Inclusions:\r\n\r\n          -  Age >18 y/o, undergoing clinically indicated endovascular therapy (balloon\r\n             angioplasty, stenting, atherectomy or combination) for lower extremity peripheral\r\n             artery disease (PAD) and claudication or critical limb ischemia (CLI). Rutherford\r\n             Category 2-6.\r\n\r\n          -  Includes iliac lesions, common femoral, superficial femoral artery, popliteal artery\r\n             and tibial vessels\r\n\r\n          -  A subject can be enrolled more than once (up to a maximum of two total times) for\r\n             treatment of a staged lesion but must wait at least 6 weeks from the completion of the\r\n             last study enrollment.\r\n\r\n        Exclusions:\r\n\r\n          -  No pregnant females\r\n\r\n          -  No vulnerable populations (dementia, prisoners, children)\r\n\r\n          -  Baseline bradycardia (heart rate <50 beats/min) or hypotension (systolic blood\r\n             pressure <90 mm Hg) will be excluded from receiving adenosine\r\n      ","sponsor":"The University of Texas Health Science Center at San Antonio","sponsor_type":"Other","conditions":"Peripheral Arterial Disease|Fractional Flow Reserve|Hemodynamics","interventions":[{"intervention_type":"Device","name":"Device: Translesional Hemodynamic Measurement","description":"Measurement of hemodynamics using the NAVVUS catheter during endovascular therapy"}],"outcomes":[{"outcome_type":"primary","measure":"Measurement of Change in translesional pressure gradients to determine change in bloodflow with sequential endovascular procedures","time_frame":"At baseline before catheter insertion, after the catheter is first inserted, to obtain initial blood flow reading, then immediately after the each attempt to clear the blockage, up to 5 times during the procedure.","description":"Observational: • During treatment of Lesion a catheter is inserted into the diseased portion of the artery to remove the plaque and improve the blood flow through the artery. This measurement, which may be repeated 5 times during the treatment, to measure the blood flow at a point before and after the section of the artery with the blockage"}]}
{"nct_id":"NCT03106753","start_date":"2017-04-12","phase":"Phase 4","enrollment":34,"brief_title":"Success of External Cephalic Version Study","official_title":"Success of External Cephalic Version With Immediate Spinal Anesthesia Versus Spinal Anesthesia When Attempt Without Anesthesia Has Failed: A Randomized Controlled Trial","primary_completion_date":"2018-05-05","study_type":"Interventional","rec_status":"Terminated","completion_date":"2018-05-05","last_update":"2020-10-09","description":"The purpose of this study is to determine the best way to optimize the success of external cephalic version (turning the baby from the outside). Attempting to turn babies in-utero is recommended because it may decrease the risk of needing a cesarean section for abnormal presentation. While the study team knows that this procedure can be effective, the study team still has some un-answered questions as to the best way to perform this procedure to increase the chance of success. Many prior studies have shown that using spinal anesthesia (a shot of medication placed in your back to numb and relax the abdomen) can increase the success rate of a version. This ultimately has led to the finding that using this anesthesia can decrease the rate of cesarean section. However, there have been only a small number of studies assessing the success rate if spinal anesthesia is used only in the event that without it fails. Therefore the study team is going to compare patients who receive spinal anesthesia with those who only receive spinal anesthesia if the procedure to turn the baby (ECV) fails without it.","other_id":"GCO 17-0236","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients included are those with singleton pregnancies of at least 37 weeks gestation\r\n             in nonvertex presentation with no contraindication for a vaginal delivery.\r\n\r\n          -  Membranes must be intact with a minimum of a 2x2 pocket and Category 1 non-stress\r\n             test.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  All patients with a contraindication for a vaginal delivery will be excluded from the\r\n             study.\r\n\r\n          -  Patients with gross fetal anomalies or uterine malformations.\r\n\r\n          -  Patients with contraindications to neuraxial anesthesia or allergies to any of the\r\n             study medications will also be excluded.\r\n      ","sponsor":"Icahn School of Medicine at Mount Sinai","sponsor_type":"Other","conditions":"External Cephalic Version","interventions":[{"intervention_type":"Drug","name":"Drug: Bupivacaine","description":"intrathecal bupivacaine 7.5 mg"},{"intervention_type":"Drug","name":"Drug: Terbutaline","description":"0.25 mg Terbutaline subcutaneously"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants With Success Rate of External Cephalic Version to Cephalic Presentation.","time_frame":"Day 1","description":"Success rate will be measured by comparing the percentage of successful external cephalic versions in each group."},{"outcome_type":"secondary","measure":"Time From Procedure to Delivery.","time_frame":"up to day 42","description":"Number of days from procedure to delivery."},{"outcome_type":"secondary","measure":"Number of Participants With Various Mode of Delivery","time_frame":"up to day 42","description":"Mode of delivery as incidence of spontaneous vaginal delivery, operative vaginal delivery, or cesarean section."},{"outcome_type":"secondary","measure":"Numeric Rating Scale (NRS-11)","time_frame":"Day 1","description":"Patient discomfort rated with NRS-11. Total scale from 0-10, with higher score indicating more pain."},{"outcome_type":"secondary","measure":"Number of Adverse Events During Procedure","time_frame":"Day 1","description":"Number of total specific adverse events such as: fetal bradycardia, emergent cesarean section, or abruption."},{"outcome_type":"secondary","measure":"Newborn Birth Weight","time_frame":"Day 1 of delivery","description":"Newborn birth weight in grams."},{"outcome_type":"secondary","measure":"Number of Participants With Newborns With Apgar Score 7 or 9","time_frame":"7 minutes and 9 minutes after delivery","description":"Newborns with Apgar Score 7 or 9 at 5 minutes after delivery. The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health."},{"outcome_type":"secondary","measure":"Cord pH","time_frame":"Day 1","description":"Arterial cord pH level"},{"outcome_type":"secondary","measure":"Number of NICU Admission","time_frame":"Day 1","description":"Number of patients whose neonate was admitted to the NICU in each group."}]}
{"nct_id":"NCT03111238","start_date":"2017-04-05","phase":"Phase 3","enrollment":3,"brief_title":"The Efficacy and Safety of REX-001 to Treat Ischemic Rest Pain in Subjects With CLI Rutherford Category 4 and DM","official_title":"The Efficacy and Safety of Intra-arterial Administration of REX-001 to Treat Ischemic Rest Pain in Subjects With Critical Limb Ischemia (CLI) Rutherford Category 4 and Diabetes Mellitus (DM): a Pivotal, Placebo-controlled, Double-blind, Parallel-group, Adaptive Trial","primary_completion_date":"2021-03-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2021-03-31","last_update":"2021-05-07","description":"This trial is a pivotal, placebo-controlled, double-blind, parallel-group, adaptive trial conducted in subjects with DM and CLI Rutherford Category 4. Minimisation will be used to assign eligible subjects in a 2:1 ratio to receive a single intra-arterial administration of REX-001 or matching placebo into the index limb.","other_id":"REX-001-004","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Aged  18 to  85 years.\r\n\r\n          2. Diagnosis of Type I or II DM, established more than one year ago.\r\n\r\n          3. Glycosylated hemoglobin (HbA1c) < 9%.\r\n\r\n          4. Subjects with poor or no (surgical or endovascular) revascularization option\r\n             classified as CLI Rutherford Category 4. The blood circulation in these subjects must\r\n             be compromised at screening, defined as:\r\n\r\n               -  Ankle systolic pressure < 50 mm Hg, or\r\n\r\n               -  Toe systolic pressure < 30 mm Hg, or\r\n\r\n               -  TcpO2 < 30 mm Hg, and\r\n\r\n               -  Flat or barely pulsatile ankle or metatarsal PVR\r\n\r\n          5. In the opinion of the Investigator, the subject is controlled on medical therapy\r\n             indicated for CLI (unless there is a documented contraindication or intolerance) and\r\n             pain management is optimized.\r\n\r\n          6. Women of childbearing potential (i.e., fertile, following menarche and until becoming\r\n             post-menopausal unless permanently sterile) must have a negative pregnancy test at\r\n             screening. Men and women who are sexually active shall use effective contraceptive\r\n             methods for the duration of their participation in this study if the partner of the\r\n             male participant, or if the female participant is of childbearing potential.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Advanced CLI defined as presence of major tissue loss as significant\r\n             ulceration/gangrene proximal to the metatarsal heads (CLI Rutherford Category 6).\r\n             Significant ulceration/gangrene means any ulceration that extends beyond the\r\n             subcutaneous tissue layer, or any gangrene or tissue necrosis proximal to the\r\n             metatarsal heads.\r\n\r\n          2. CLI Rutherford Category 5.\r\n\r\n          3. Uncontrolled or untreated proliferative retinopathy.\r\n\r\n          4. Failed surgical or endovascular revascularization on the index leg within 10 days\r\n             after the procedure.\r\n\r\n          5. Subjects in whom arterial insufficiency in the lower extremity is the result of acute\r\n             limb ischemia or an immunological or inflammatory or non-atherosclerotic disorder\r\n             (e.g., thromboangiitis obliterans (Buerger's Disease), systemic sclerosis (both\r\n             limited and diffuse forms).\r\n\r\n          6. Clinical evidence of invasive infection on index leg defined as major tissue loss at\r\n             the mid-foot or heel involving tendon and/or bone, and/or when intravenous antibiotics\r\n             are required to treat the infection according to the Investigator.\r\n\r\n          7. At screening, the presence of only neuropathic ulcers on the index leg.\r\n\r\n          8. Amputation at or above the talus on the index leg.\r\n\r\n          9. Planned major amputation within the first month after randomization.\r\n\r\n         10. On the index leg, use of concomitant wound treatments not currently approved for\r\n             ischemic wound-healing within 30 days prior to screening or plans to initiate new,\r\n             nonstandard-of-care treatments to the index leg during the trial.\r\n\r\n         11. Blood clotting disorder not caused by medication (e.g., thrombophilia).\r\n\r\n         12. Severe hypertension according to the Joint National Committee on Prevention,\r\n             Detection, Evaluation, and Treatment of High Blood Pressure.\r\n\r\n         13. A platelet count < 50,000/ L.\r\n\r\n         14. International normalised ratio (INR) > 1.5. For patients on anticoagulant medication\r\n             an INR > 1.5 is allowed, provided that the Investigator and the haematologist consider\r\n             the patient eligible to collect BM.\r\n\r\n         15. Evidence of moderate to severe hepatocellular dysfunction according to the treating\r\n             physician.\r\n\r\n         16. Positive test for human immunodeficiency virus 1 (HIV 1), HIV 2, hepatitis B virus\r\n             (HBV), hepatitis C virus (HCV) or Treponema pallidum.\r\n\r\n         17. Subjects who may not be healthy enough to successfully complete all protocol\r\n             requirements including BM collection, or who are not expected to survive more than 12\r\n             months, or in whom results may be particularly difficult to assess, as assessed by the\r\n             Investigator.\r\n\r\n         18. Subjects who participate in another clinical interventional trial.\r\n\r\n         19. Subjects who have been treated with experimental medication within 30 days of\r\n             screening.\r\n\r\n         20. Subjects who were treated with other cell therapies for CLI within the last 12 months\r\n             preceding the screening visit.\r\n      ","sponsor":"Ixaka Ltd","sponsor_type":"Industry","conditions":"Peripheral Arterial Disease (PAD)|Diabetes Mellitus (DM)|Diabetes Mellitus, Type 1|Diabetes Mellitus, Type 2|Cardiovascular Disease|Critical Limb Ischemia (CLI)","interventions":[{"intervention_type":"Drug","name":"Drug: REX-001","description":"REX-001 is administered through an intra-arterial catheter."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo is administered through an intra-arterial catheter."}],"outcomes":[{"outcome_type":"primary","measure":"Complete relief of ischemic rest pain without developing ischemic lesions on the index leg.","time_frame":"The primary endpoint for this trial will be assessed at 12 months.","description":"Change in Rutherford classification from CLI Category 4 to Category 3 or lower 12 months after administration of REX-001 or placebo."}]}
{"nct_id":"NCT03133351","start_date":"2017-04-04","enrollment":240,"brief_title":"Reference Range Analysis of the Entegrion Point of Care Coagulation Monitor (PCM) in Healthy Volunteers","official_title":"Reference Range Analysis of the Entegrion Point of Care Coagulation Monitor (PCM) in Healthy Volunteers","primary_completion_date":"2020-12-30","study_type":"Observational","rec_status":"Active, not recruiting","completion_date":"2021-03-31","last_update":"2020-04-16","description":"This study is intended to define the PCM normal laboratory range.","other_id":"PCM-001","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Healthy volunteers","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age  18 years old\r\n\r\n          2. Body Mass Index (BMI)  19 and  30 kg/m2m with body weight  50 kg (106 lb)\r\n\r\n          3. Normal vital signs at screening\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Current daily tobacco use or previous recreational drug use\r\n\r\n          2. Pregnant or lactating at the time of the study\r\n\r\n          3. Currently taking any medications known to affect coagulation\r\n\r\n          4. History of excessive bleeding from minor trauma that required medical attention,\r\n             spontaneous nose bleeds that required medical attention or multiple spontaneous\r\n             abortions, liver disease, blood related diseases, congenital or acquired\r\n             coagulopathies or thromboembolic diseases\r\n\r\n          5. Current diagnosis of cancer\r\n      ","sponsor":"Entegrion, Inc.","sponsor_type":"Industry","conditions":"Coagulation","interventions":[{"intervention_type":"Device","name":"Device: PCM","description":"A fresh whole blood sample will be tested by PCM to determine the reference range."}],"outcomes":[{"outcome_type":"primary","measure":"PCM Clotting Time (CT)","time_frame":"Testing to be initiated within 4 minutes of sample collection","description":"To define the PCM normal laboratory reference range, PCM clotting time (CT) will be measured."},{"outcome_type":"primary","measure":"Clot Formation Time (CFT)","time_frame":"Testing to be initiated within 4 minutes of sample collection","description":"To define the PCM normal laboratory reference range, clot formation time (CFT) will be measured."},{"outcome_type":"primary","measure":"Alpha Angle (AA)","time_frame":"Testing to be initiated within 4 minutes of sample collection","description":"To define the PCM normal laboratory reference range, alpha angle (AA) will be measured.\r\nTo define the PCM normal laboratory reference range, clot formation time (CFT) will be measured."},{"outcome_type":"primary","measure":"Maximum Clot Firmness (MCF)","time_frame":"Testing to be initiated within 4 minutes of sample collection","description":"To define the PCM normal laboratory reference range, maximum clot firmness (MCF) will be measured."},{"outcome_type":"primary","measure":"30-minutes Lysis after CT (LI30)","time_frame":"Testing to be initiated with 4 minutes of sample collection, with result available 30 minutes after CT","description":"To define the PCM normal laboratory reference range, 30-minutes lysis after CT (LI30) will be measured."},{"outcome_type":"primary","measure":"45-minutes Lysis after CT (LI45)","time_frame":"Testing to be initiated within 4 minutes of sample collection, with result available 45 minutes after CT","description":"To define the PCM normal laboratory reference range, 45-minutes lysis after CT (LI45) will be measured."}]}
{"nct_id":"NCT03131830","start_date":"2017-04-01","enrollment":2605,"brief_title":"Individual Choice of Delivery Mode","official_title":"Individual Choice of Delivery Mode - A Prospective Study Using Online Surveys","primary_completion_date":"2018-01-01","study_type":"Observational","rec_status":"Completed","completion_date":"2018-05-01","last_update":"2018-10-17","description":"The primary aim of the study is to investigate personal attitudes regarding mode of delivery among both medical health care professionals and non-professionals. The investigators are also investigating whether providing detailed information that might influence one's decision regarding mode of delivery (such as education on pelvic floor disorders or advantages or disadvantages of epidural anaesthesia) will change participants opinion how to determine their preferred mode of delivery.","other_id":"DECISION","observational_model":"Other","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"There will be two groups in this study. The first group (\"medical professionals\") consists\r\n        of gynecologists with either subspecialization (urogynecology , fetal and maternal\r\n        medicine, obstetrics, other) and other non-OB/GYN health care providers and medical staff,\r\n        regardless whether they are nurses, medical assistants, physicians, physiotherapists,\r\n        midwifes, administration staff. The group of \"non-professionals\" consists of women who are\r\n        currently pregnant, and are not healthcare professionals.\r\n\r\n        Inclusion Criteria:\r\n\r\n        Participants in the \"medical professionals\" group can be from either gender, over age 18,\r\n        currently working in the medical profession and have sufficient understanding of the German\r\n        language in order to be able to fill out the questionnaire.\r\n\r\n        The \"non-professionals\" are pregnant females over age 18 with sufficient understanding of\r\n        the German language in order to be able to fill out the questionnaire.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  able to fill out a questionnaire\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  minor people\r\n      ","sponsor":"University Women's Hospital Tbingen","sponsor_type":"Other","conditions":"Delivery Mode","interventions":[{"intervention_type":"Other","name":"Other: Online-based questionnaire","description":"Participants receive a web-link to a questionnaire, which is active for 3 months"}],"outcomes":[{"outcome_type":"primary","measure":"Delivery mode","time_frame":"3 months","description":"Choice of delivery mode"}]}
{"nct_id":"NCT02964039","start_date":"2017-04-01","phase":"N/A","enrollment":54,"brief_title":"A Novel Mechanics-based Intervention to Improve Post-stroke Stability","official_title":"A Novel Mechanics-based Intervention to Improve Post-stroke Gait Stability","primary_completion_date":"2020-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-03-31","last_update":"2021-07-28","description":"The purpose of this study is to determine whether a novel treadmill training intervention can improve the gait stabilization strategy used by individuals who have experienced a stroke.","other_id":"N2256-R","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":21,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  At least 21 years old\r\n\r\n          -  Experience of a stroke 6 months prior to participation\r\n\r\n          -  Preferred overground gait speed of at least 0.2 m/s\r\n\r\n          -  Ability to walk at self-selected speed for 3 minutes without a cane or walker\r\n\r\n          -  Provision of informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Resting heart rate above 110 beats/min\r\n\r\n          -  Resting blood pressure higher than 200/110 mm Hg\r\n\r\n          -  History of congestive heart failure, unstable cardiac arrhythmias, hypertrophic\r\n             cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities\r\n             of daily living\r\n\r\n          -  Preexisting neurological disorders or dementia\r\n\r\n          -  History of major head trauma\r\n\r\n          -  Legal blindness or severe visual impairment\r\n\r\n          -  Life expectancy <1 yr; 8)\r\n\r\n          -  History of deep vein thrombosis or pulmonary embolism within 6 months\r\n\r\n          -  Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin\r\n             reactions\r\n\r\n          -  Orthopedic injuries or conditions (e.g. joint replacements) in the lower extremities\r\n             with the potential to alter the gait pattern.\r\n      ","sponsor":"VA Office of Research and Development","sponsor_type":"U.S. Fed","conditions":"Stroke","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Error reduction","description":"During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs toward mechanically-appropriate mediolateral locations, having the effect of reducing the errors in foot placement that are often present among individuals who have experienced a stroke."},{"intervention_type":"Behavioral","name":"Behavioral: Error augmentation","description":"During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs away from mechanically-appropriate mediolateral locations, having the effect of amplifying the errors in foot placement that are often present among individuals who have experienced a stroke."},{"intervention_type":"Behavioral","name":"Behavioral: Activity matched control","description":"During training sessions, participants will interface with a custom-built force-field while they walk. The force-field will essentially get out of the way, producing minimal forces on the legs, and having no direct effect on the errors in foot placement that are often present among individuals who have experienced a stroke."}],"outcomes":[{"outcome_type":"primary","measure":"Partial Correlation Between Pelvis Displacement and Paretic Step Width During Gait (Change From Baseline)","time_frame":"6 months (assessments after 4-weeks of training, 8-weeks of training, 12-weeks of training, and a subsequent 12-week follow-up period)","description":"A custom measure that quantifies the strength of the relationship between body mechanics and foot placement. This measure falls within a relatively narrow range among neurologically intact controls, but is substantially reduced in some individuals who have experienced a stroke, indicating a reduced ability to stabilize their gait pattern."},{"outcome_type":"secondary","measure":"Functional Gait Assessment (Change From Baseline)","time_frame":"6 months (assessments after 4-weeks of training, 8-weeks of training, 12-weeks of training, and a subsequent 12-week follow-up period)","description":"A commonly-used clinical test to quantify balance and stability during various walking tasks. The minimum value is 0, the maximum value is 30, and higher scores indicate better outcomes."},{"outcome_type":"secondary","measure":"Activities-specific Balance Confidence Scale (Change From Baseline)","time_frame":"6 months (assessments after 4-weeks of training, 8-weeks of training, 12-weeks of training, and a subsequent 12-week follow-up period)","description":"A commonly-used clinical scale that quantifies an individual's confidence in performing various tasks requiring balance. The minimum value is 0, the maximum value is 100, and higher scores indicate a better outcome."},{"outcome_type":"secondary","measure":"10-meter Walk Test (Change From Baseline)","time_frame":"6 months (assessments after 4-weeks of training, 8-weeks of training, 12-weeks of training, and a subsequent 12-week follow-up period)","description":"A commonly-used clinical test to quantify general gait function. Walking speed is measured."},{"outcome_type":"secondary","measure":"Fall Incidence","time_frame":"6 months (during 12 week follow-up period)","description":"Self-report history of fall occurrence"},{"outcome_type":"secondary","measure":"Fear of Falling","time_frame":"6 months (at completion of 12-week Follow-up period)","description":"Self-report statement of whether a participant has a fear of falling"}]}
{"nct_id":"NCT03007485","start_date":"2017-04-01","phase":"N/A","enrollment":276,"brief_title":"A Comprehensive Disease Management Program to Improve Quality of Life in Disparity Hispanic and African-American Patients Admitted With Exacerbation of Chronic Pulmonary Diseases","official_title":"A Comprehensive Disease Management Program to Improve Quality of Life in Disparity Hispanic and African-American Patients Admitted With Exacerbation of Chronic Pulmonary Diseases","primary_completion_date":"2019-06-15","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2020-11-15","last_update":"2020-03-09","description":"Chronic Obstructive Pulmonary Disease (COPD), also known as emphysema, is the leading cause of hospitalization for older adults in the U.S., and a leading cause of death. Although there is no cure for COPD, a program called pulmonary rehabilitation (PR), which combines exercise and education, can help decrease re-hospitalizations and improve patients' quality of life. Unfortunately, very few COPD Latino and African-American patients actually get PR. These patients are unlikely to get referrals or to be able to attend PR due to lack of insurance, lack of transportation, or lack of a PR center in their area. Telehealth is a way of using computers to deliver healthcare long-distance, eliminating the need for a patient to travel to receive care. By using telehealth for PR, the patient can exercise on a stationary bike in his or her home, while being supervised by videoconference by a respiratory therapist (RT). The RT can \"see\" the patient, and deliver education by videoconference, and the patient can \"see\" the RT, so the patient does not need to leave home to get PR.","other_id":"AD-1511-33066","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adult patients with a diagnosis of COPD (defined by one pulmonary function tests (PFT)\r\n             and who have not done pulmonary rehabilitation within the past 1 year and\r\n\r\n          -  Hispanic or African-American (as defined by the patient him/herself).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  individuals who completed PR in the past year or\r\n\r\n          -  those unable to exercise or follow directions as determined by their outpatient\r\n             pulmonologist/cardiologist or\r\n\r\n          -  A diagnosis of dementia listed in the patient's electronic medical record\r\n\r\n          -  Patients who weigh more than 300 pounds\r\n      ","sponsor":"Northwell Health","sponsor_type":"Other","conditions":"COPD Exacerbation","interventions":[{"intervention_type":"Other","name":"Other: Telehealth Pulmonary Rehabilitation","description":"Exercise bikes equipped with software that enables a respiratory therapist to remotely conduct a pulmonary rehabilitation session with a patient while he or she is at home (or at a local community center). The patient's vital signs are continually monitored and the RT is able to remotely alert 911 if a patient is in distress. Educational videos and stretching exercises are also incorporated into this session to mimic what a standard pulmonary rehabilitation session offers."}],"outcomes":[{"outcome_type":"primary","measure":"Change in the rate of rehospitalizations in patients with COPD","time_frame":"6 months post-discharge from hospitalization following COPD exacerbation","description":"The investigators will analyze the change in the rate of patients' rehospitalizations following completion of pulmonary rehabilitation (PR)."},{"outcome_type":"secondary","measure":"Change in functional capacity after pulmonary rehabilitation","time_frame":"Prior to beginning PR, after completion of PR, and 6 months and12 months post-discharge from hospitalizations following COPD exacerbation","description":"The investigators will analyze the change in patients' functional capacity, as measured prior to beginning PR, immediately following completion of PR, 6 months post-hospital discharge, and 12 months post-hospital discharge."},{"outcome_type":"secondary","measure":"Change in self-reported quality of life after pulmonary rehabilitation","time_frame":"Prior to beginning PR, after completion of PR, and 6 months and12 months post-discharge from hospitalizations following COPD exacerbation","description":"The investigators will analyze the change in patients' quality of life based on self-reported outcome measurements, as measured prior to beginning PR, immediately following completion of PR, 6 months post-hospital discharge, 12 months post-hospital discharge."},{"outcome_type":"secondary","measure":"Measure of patients' adherence to completing pulmonary rehabilitation","time_frame":"8 weeks post-discharge from hospitalization following COPD exacerbation","description":"Given the improved convenience and access to PR, the investigators are looking to measure the degree to which patients adhere to their pulmonologists' referrals for pulmonary rehabilitation."}]}
{"nct_id":"NCT03549793","start_date":"2017-04-01","phase":"N/A","enrollment":100,"brief_title":"Can Dance Therapy Improve Motor Learning in Parkinson's Disease (PD)?","official_title":"Can Dance Therapy Improve Motor Learning in Parkinson's Disease?","primary_completion_date":"2018-06-01","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2018-06-30","last_update":"2018-06-08","description":"In order to find the most effective rehabilitative therapies for Parkinsonian patients, the present study is aimed to evaluate whether, in a multidisciplinary intensive rehabilitation treatment, the dance therapy, applied to the motor learning, promote additional benefits.","other_id":"dance therapy in PD","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","intervention_model_description":"Participants are randomly assigned to experimental group or control group. Both of the groups undergo a rehabilitation treatment. The experimental group undergoes 4-week MIRT (Multidisciplinary Intensive Rehabilitation Treatment) + dance therapy. The control group undergoes 4-week MIRT (Multidisciplinary Intensive Rehabilitation Treatment) + exercises","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Stage 2.5-3 according to the Hoehn and Yahr scale (H&Y);\r\n\r\n          -  Stable pharmacological treatment for the last 6 weeks before the enrolment and during\r\n             the hospitalization;\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any focal brain lesion detected in brain imaging studies (CT or MRI) performed in the\r\n             previous 12 months;\r\n\r\n          -  Drug-induced dyskinesias;\r\n\r\n          -  Disturbing resting and/or action tremor, corresponding to scores 2-4 in the specific\r\n             items of UPDRS III;\r\n\r\n          -  Behavioral disturbances (evaluated with Neuropsychiatric Inventory);\r\n\r\n          -  Visual and auditory dysfunctions according to the general clinical evaluation and\r\n             medical history;\r\n\r\n          -  cognitive decline (MMSE correct score < 24)\r\n      ","sponsor":"Ospedale Generale Di Zona Moriggia-Pelascini","sponsor_type":"Other","conditions":"Parkinson Disease","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Dance Therapy","description":"the intervention is aimed to ameliorate, through dancing, crucial motor symptoms in PD patients, as walking, balance, postural changes and arm swing"},{"intervention_type":"Behavioral","name":"Behavioral: exercises without dance","description":"the intervention consists of exercises aimed at training the walking, the balance, the postural changes and the arm swing"}],"outcomes":[{"outcome_type":"primary","measure":"Timed Up and Go Test (TUG)","time_frame":"4 weeks","description":"To determine fall risk and measure the progress of balance, sit to stand, and walking."},{"outcome_type":"secondary","measure":"6 Minutes Walking Test (6MWT)","time_frame":"4 weeks","description":"The 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes."},{"outcome_type":"secondary","measure":"Balance Berg Scale (BBS)","time_frame":"4 weeks","description":"to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks."},{"outcome_type":"other","measure":"delayed recall of items","time_frame":"4 weeks","description":"number of specific items correctly performed in recall phase"}]}
{"nct_id":"NCT03469596","start_date":"2017-04-01","enrollment":87,"brief_title":"Evaluation by MRI of Anal Canal Cell Carcinoma: is There Predictive Factor?","official_title":"Evaluation by MRI of Anal Canal Cell Carcinoma: is There Predictive Factor?","primary_completion_date":"2017-05-01","study_type":"Observational","rec_status":"Completed","completion_date":"2017-12-31","last_update":"2018-03-22","description":"Anal canal cell carcinoma is a very rare cancer but well treated. If the morphological test are well established in the initial evaluation, it's not the case of the follow up evaluation particularly by MRI.About 1/3 of patient decline with metastatic relapse during the follow up of these patients.It appears that clinical regression seen precociously is a predictive factor of survival without relapse. But there 's no study confirming that point. This context takes us to evaluate if there is a predictive factor in MRI to final clinical result.","other_id":"IRMcanalANAL","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"every patient with anal canal cell carcinoma with an initial MRI in GHPS between 1st august\r\n        2009 and 24th april of 2015","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  patient with anal canal cell carcinoma histologically proved\r\n\r\n          -  patient with initial MRI and follow up MRI in Hospital St Joseph's radiology yard.\r\n\r\n          -  patient for whom a radio chemotherapy treatment decision was taken.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  patients with already metastatic lesions\r\n      ","sponsor":"Groupe Hospitalier Paris Saint Joseph","sponsor_type":"Other","conditions":"Anal Carcinoma","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: MRI sequence","description":"several MRI sequence before and after contrast product injection."}],"outcomes":[{"outcome_type":"primary","measure":"Distance with regard to the anal margin","time_frame":"maximum of 6 years after the initial MRI","description":"tumor position"},{"outcome_type":"primary","measure":"initial tumor size","time_frame":"maximum of 6 years after the initial MRI","description":"Maximal tumoral size in the cranio-caudal plan in cm"},{"outcome_type":"primary","measure":"presence of nodal status","time_frame":"maximum of 6 years after the initial MRI","description":"presence of nodal status in inguinal region"}]}
{"nct_id":"NCT02091700","start_date":"2017-03-31","enrollment":30,"brief_title":"ObseRvation of PeripHEral rEtinal Morphology in Normals","official_title":"ObseRvation of PeripHEral rEtinal Morphology in Normal","primary_completion_date":"2017-07-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2017-07-31","last_update":"2017-03-13","description":"To develop a database of the peripheral choroidal circulation using ultra widefield (UWF) imaging. This database will serve as a quantitative reference tool for the comparison of subjects to a database of known normal subjects.","other_id":"OPT1010","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":20,"population":"Normal subjects with no known retinal disease or choroidal disease.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subjects older than 20 years old with good general health.\r\n\r\n          -  Subject is capable of giving consent.\r\n\r\n          -  The subject is able and willing to comply with the study procedures.\r\n\r\n          -  Subjects with ocular media clear enough to allow good quality ocular imaging.\r\n\r\n          -  Normal subjects with no known retinal or choroidal disease.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subjects under 20 years old.\r\n\r\n          -  Subjects with contraindications to dilation.\r\n\r\n          -  Subjects with a history of epilepsy.\r\n\r\n          -  Subjects with a known allergy to iodine, shellfish or intra-venous x-ray contrast\r\n             dyes.\r\n\r\n          -  Subjects who are or who may be pregnant.\r\n\r\n          -  Subjects with past history of any vitreoretinal disease or surgery such as retinal\r\n             detachment, epiretinal membrane, or vitreous hemorrhage.\r\n\r\n          -  Subjects with any ocular condition that interferes with good quality image\r\n             acquisition, such as corneal opacities, cataract, and dense vitreous hemorrhage.\r\n\r\n          -  Subjects with any evidence of any retinal or optic nerve disease including glaucoma.\r\n\r\n          -  Subjects with any anterior segment disease with the exception of common ocular surface\r\n             disorders (blepharitis, dry eye).\r\n\r\n          -  Subjects with medical conditions that interfere with the subject's compliance to study\r\n             procedures such as inability of the subject to maintain steady head or eye positioning\r\n             as in patients of ataxia or nystagmus.\r\n\r\n          -  Subjects with a history of Diabetes, uncontrolled blood pressure (defined as systolic\r\n             >/= 160mmHg and/or diastolic >/= 90 mmHg), and Vascular Disease (cardiovascular,\r\n             peripheral vascular, or cerebrovascular).\r\n\r\n          -  Subjects on vasodilators.\r\n\r\n          -  Subject's refusal.\r\n      ","sponsor":"Optos, PLC","sponsor_type":"Industry","conditions":"Healthy","interventions":[{"intervention_type":"Other","name":"Other: Indocyanine Green ICG"}],"outcomes":[{"outcome_type":"primary","measure":"Develop a database of peripheral retinal circulation in normals using UWF-ICG imaging","time_frame":"1 day"},{"outcome_type":"secondary","measure":"Develop a database of peripheral retinal morphology on age stratified normals using color, AF and ICG imaging","time_frame":"1 day"}]}
{"nct_id":"NCT03575390","start_date":"2017-03-30","phase":"N/A","enrollment":120,"brief_title":"The Beneficial Effects of Pomegranate on Hearing of Patients Without Hemodialysis","official_title":"The Beneficial Effects of Pomegranate on Hearing of Patients Without Hemodialysis: A Prospective, Randomized, Double-blinded Clinical Trial","primary_completion_date":"2022-01-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-01-31","last_update":"2021-08-30","description":"Pomegranate has anti-oxidative capacity. It might reduce symptoms of Alzheimer's disease, Drug-induced hepatitis, and might prevent deterioration of cardiovascular diseases and cancer progression. But, the beneficial effects of pomegranate on hearing impairment was still unclear. This study aimed to investigate the beneficial effects of pomegranate on hearing impairment by a prospective, randomized, double-blinded clinical trial design. The investigators'll include 120 elderly patients without hemodialysis in our hospital, and divided them into 2 groups. Control group will receive placebo treatment; pomegranate group will receive oral pomegranate (500 mg, twice per day). All patients will receive above treatment for 9 months, and receive examinations of pure tone audiometry, word discrimination score before start of this clinical trial, 4.5th month after the start day, the end of treatment (the 9th month), and 4.5 months after the treatment (the 13.5th month).","other_id":"B10601002-1","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":50,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age 50 to 80 years old.\r\n\r\n          2. non-renal dialysis patients.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Life can not take care of themselves or the bed of a patient.\r\n\r\n          2. dialysis patients.\r\n\r\n          3. Patients who can not understand the details of this study or are unable to cooperate\r\n             with the examination.\r\n\r\n          4. history of alcohol or drug abuse.\r\n\r\n          5. history of high environmental noise exposure.\r\n\r\n          6. The pure tone hearing threshold is greater than 10 decibel (dB), and the audiogram 4\r\n             kilohertz (kHz) air conduction threshold is greater than 8 kilohertz (kHz) air\r\n             threshold value of 20 decibel (dB).\r\n      ","sponsor":"Dalin Tzu Chi General Hospital","sponsor_type":"Other","conditions":"Hearing Impairment","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Placebo","description":"The gel contains a mixture of glucose and maltodextrin - a complex carbohydrate - along with fat and a trace of protein."},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Pomegranate","description":"Pomegranate extract 500mg"}],"outcomes":[{"outcome_type":"primary","measure":"Pure tone audiometry (PTA)","time_frame":"9 months","description":"pure tone thresholds of 250, 500, 1000, 2000, 4000, 8000 Hz were measured."},{"outcome_type":"secondary","measure":"speech reception threshold (SRT)","time_frame":"9 months","description":"The speech recognition threshold is the lowest hearing level at which speech can barely be recognized or understood. The SRT is defined as the lowest hearing level at which the patient correctly repeats 50% of a list of spondaic words. Examples are airplane, hot dog, outside, ice cream, and baseball. Usually a very soft level (db HL)."},{"outcome_type":"secondary","measure":"speech discrimination score (SDS)","time_frame":"9 months","description":"The SDS test tool is a single syllable word list. Each table consists of 50 words, such as, look, go. The test method is to listen to the subject at a volume higher than the SRT value of 20 to 40 dB (30 dB), so that the subject repeats the spoken word sound. Based on the percentage of correct answers, normal people can repeat 95 to 100% of the words, and 80% or less of them are bad discriminating power and affect the understanding of language. SDS is usually expressed in %."}]}
{"nct_id":"NCT03078985","start_date":"2017-03-30","phase":"N/A","enrollment":36,"brief_title":"Cardiovascular Magnetic Resonance-Guided Radiofrequency-Ablation for Atrial Flutter II","official_title":"Cardiovascular Magnetic Resonance-Guided Radiofrequency-Ablation for Atrial Flutter","primary_completion_date":"2017-12-11","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-01-15","last_update":"2019-02-19","description":"The purpose of this clinical study is to assess the safety and performance of the Vision-MR Ablation Catheter, the primary safety endpoint will measure the rate of serious adverse events related to the device or procedure; the primary performance endpoint will measure the acute success rate defined as the demonstration of bidirectional cavo-tricuspid isthmus block after radiofrequency application in the cavo-tricuspid isthmus; the secondary performance endpoint will measure the chronic success rate defined as the freedom of recurrence of type 1 atrial flutter at three months post-ablation procedure. The study will be a single center study conducted at the Leipzig University Hospital Heart Center in Germany. The study population will consist of adult patients requiring ablation for type I atrial flutter. This is the follow-up study to NCT02699034.","other_id":"2016-IMR","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  First time indication for ablation for type I atrial flutter.\r\n\r\n          -  Patients willing and able (mentally and physically capable per physician's discretion)\r\n             to understand the investigational nature, potential risks and benefits of the study\r\n             and able to provide written informed consent to participate in the study and agree to\r\n             comply with follow-up visits and evaluation\r\n\r\n          -  Patients able to receive anticoagulation therapy to achieve adequate anticoagulation\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Contraindication for MRI diagnostic exam\r\n\r\n          -  A cardiac ablation or cardiac surgery within 180 days prior to enrollment\r\n\r\n          -  Documented intracardiac thrombus, tumor, bleeding, clotting or other abnormality that\r\n             precludes catheter introduction and placement\r\n\r\n          -  Myocardial infarction within 60 days prior to enrollment\r\n\r\n          -  Current unstable angina\r\n\r\n          -  History of cerebrovascular event (within 180 days prior to enrollment)\r\n\r\n          -  Patients with an ejection fraction less than or equal to 35% within 90 day prior to\r\n             enrollment\r\n\r\n          -  Permanent leads in or through the right atrium\r\n\r\n          -  Clinically significant structural heart disease (including tricuspid valve\r\n             regurgitation, tricuspid valve stenosis or other congenital heart disease) that would\r\n             preclude catheter introduction and placement, as determined by the Investigator\r\n\r\n          -  Uncompensated congestive heart failure (NYHA Class III or IV)\r\n\r\n          -  Arrhythmia is secondary to electrolyte imbalance, thyroid disease, or other reversible\r\n             or non-cardiovascular cause\r\n\r\n          -  Known sensitivity to heparin or warfarin\r\n\r\n          -  Active or systemic infection\r\n\r\n          -  Any other significant uncontrolled or unstable medical condition (including but not\r\n             limited to hypertension and diabetes)\r\n\r\n          -  contraindication for conventional ablation procedure know allergy against\r\n             radiocontrast agents renal insufficiency with glomerular filtration rate <\r\n             30ml/min/1,73m2\r\n\r\n          -  Women who are pregnant or plan to become pregnant within the course of their\r\n             participation in the investigation or who are breastfeeding\r\n\r\n          -  Life expectancy of less than 12 months\r\n\r\n          -  Patients with prosthetic valves\r\n\r\n          -  Contraindicated for transfemoral venous access\r\n\r\n          -  Older than 75 years\r\n\r\n          -  Current enrollment in any other clinical investigation\r\n      ","sponsor":"University of Leipzig","sponsor_type":"Other","conditions":"Atrial Flutter","interventions":[{"intervention_type":"Procedure","name":"Procedure: ablation for typical atrial flutter","description":"Typical atrial flutter is treated by catheter ablation."},{"intervention_type":"Device","name":"Device: catheter ablation with study device","description":"The study device is used inside the MRI environment to localize the cavotricuspid isthmus (CTI). The CTI is then treated with radiofrequency energy to achieve complete isthmus block."}],"outcomes":[{"outcome_type":"primary","measure":"Number of patients with bidirectional cavo-tricuspid isthmus block after intervention","time_frame":"9 months","description":"Acute success defined as the demonstration of the established electrophysiological endpoint (e.g. bidirectional cavo-tricuspid isthmus block after radiofrequency application in the cavo-tricuspid isthmus) with the investigational device. Historically, the acute success rate for RF ablation of type I atrial flutter is 85%. Analysis will be based on a binomial proportion and expressed as a percentage. For a total of N subjects with S achieving success, the percentage, represented as P, will be calculated as P = 100*S/N."},{"outcome_type":"primary","measure":"Number of patients with periinterventional serious adverse events","time_frame":"9 months","description":"The primary safety endpoint is the rate of serious adverse events (SAEs) related to the device or procedure assessed at the 7-day follow-up. Analysis will be based on a binomial proportion and expressed as a percentage. For a total of N subjects with S experiencing an SAE related to the device or procedure, the percentage, represented as P, will be calculated as P = 100*S/N."},{"outcome_type":"primary","measure":"Number of patients with freedom from recurrence from type I atrial flutter 3 months (chronic success rate) after ablation (study procedure).","time_frame":"9 month","description":"The primary chronic performance endpoint is the chronic success rate defined as freedom from recurrence of type 1 atrial flutter at 3 months post procedure. Freedom of recurrence of type I atrial flutter is assessed using symptom survey, ECG and echocardiogram data. This will be evaluated separately for all subjects treated with the device and for all subjects that achieved acute success (defined by the primary acute performance endpoint)."},{"outcome_type":"secondary","measure":"Number of patients with freedom from recurrence from type I atrial flutter 6 months after ablation (study procedure).","time_frame":"9 month","description":"The secondary performance endpoint is the chronic success rate defined as freedom from recurrence of type 1 atrial flutter at 6 months post procedure. Freedom of recurrence of type I atrial flutter is assessed using symptom survey, ECG and echocardiogram data. This will be evaluated separately for all subjects treated with the device and for all subjects that achieved chronic success (defined by the primary chronic acute performance endpoint)."}]}
{"nct_id":"NCT03063749","start_date":"2017-03-30","enrollment":416,"brief_title":"RESOLUTE ONYX Post-Approval Study","official_title":"A Post-approval Study of the Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System","primary_completion_date":"2018-10-20","study_type":"Observational","rec_status":"Active, not recruiting","completion_date":"2023-08-31","last_update":"2021-04-06","description":"To observe the continued performance of the Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System in a real-world more-comer population.","other_id":"MDT16025RES003","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"The device will be used in subjects meeting the inclusion and exclusion criteria according\r\n        to the Instructions for Use.","criteria":"\n        Key Inclusion Criteria\r\n\r\n          -  Symptomatic coronary artery disease including subjects with chronic stable angina,\r\n             silent ischemia, and acute coronary syndromes including non-ST elevation and\r\n             ST-elevation myocardial infarction\r\n\r\n          -  Subject is an acceptable candidate for treatment with a drug eluting stent in\r\n             accordance with the applicable guidelines on percutaneous coronary interventions,\r\n             manufacturer's Instructions for Use, and the Declaration of Helsinki\r\n\r\n        Key Exclusion Criteria\r\n\r\n          -  Unprotected left main disease\r\n\r\n          -  Subjects with planned PCI of three vessel disease\r\n      ","sponsor":"Medtronic Vascular","sponsor_type":"Industry","conditions":"Coronary Artery Disease","interventions":[{"intervention_type":"Device","name":"Device: Resolute Onyx Zotarolimus-Eluting Coronary Stent System","description":"Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm"},{"intervention_type":"Device","name":"Device: Resolute Onyx Zotarolimus-Eluting Coronary Stent System","description":"Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System, sizes 4.5 mm - 5.0 mm"}],"outcomes":[{"outcome_type":"primary","measure":"Target Lesion Failure","time_frame":"12 months","description":"Target Lesion Failure (TLF), defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods"},{"outcome_type":"secondary","measure":"Acute Success (Device, Lesion, Procedure)","time_frame":"30 days and 6, 12, 24, and 36 months post-procedure","description":"Acute Success (Device, Lesion, Procedure)"},{"outcome_type":"secondary","measure":"Cardiac Death","time_frame":"30 days and 6, 12, 24, and 36 months post-procedure","description":"Cardiac Death"},{"outcome_type":"secondary","measure":"Target Vessel Myocardial Infarction (TVMI)","time_frame":"30 days and 6, 12, 24, and 36 months post-procedure","description":"Target Vessel Myocardial Infarction (TVMI)"},{"outcome_type":"secondary","measure":"Target Lesion Revascularization (TLR)","time_frame":"30 days and 6, 12, 24, and 36 months post-procedure","description":"Target Lesion Revascularization (TLR)"},{"outcome_type":"secondary","measure":"Target Vessel Revascularization (TVR)","time_frame":"30 days and 6, 12, 24, and 36 months post-procedure","description":"Target Vessel Revascularization (TVR)"},{"outcome_type":"secondary","measure":"Cardiac Death and TVMI","time_frame":"30 days and 6, 12, 24, and 36 months post-procedure","description":"Cardiac Death and TVMI"},{"outcome_type":"secondary","measure":"Major Adverse Cardiac Event (MACE)","time_frame":"30 days and 6, 12, 24, and 36 months post-procedure","description":"Defined as death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods"},{"outcome_type":"secondary","measure":"Target Lesion Failure (TLF)","time_frame":"30 days and 6, 12, 24, and 36 months post-procedure","description":"Target Lesion Failure (TLF)"},{"outcome_type":"secondary","measure":"Target Vessel Failure (TVF)","time_frame":"30 days and 6, 12, 24, and 36 months post-procedure","description":"Target Vessel Failure (TVF)"},{"outcome_type":"secondary","measure":"Stent Thrombosis (ST)","time_frame":"30 days and 6, 12, 24, and 36 months post-procedure","description":"Stent Thrombosis (ST)"}]}
{"nct_id":"NCT03091608","start_date":"2017-03-25","enrollment":1000,"brief_title":"Surveillance for Early Liver Injuries Caused by Xianlin Gubao Granule","official_title":"A Registry Study to Surveil Early Liver Injuries Caused by Xianlin Gubao Granule (XLGB Granule)","primary_completion_date":"2017-12-31","study_type":"Observational [Patient Registry]","rec_status":"Unknown status","completion_date":"2017-12-31","last_update":"2017-03-27","description":"This is a prospective registry study to surveil early liver injuries caused by Xianlin Gubao Granule (XLGB Granule) through a non-intervention observational way. And attempt to establish a predictive model to screen susceptibilities to XLGB Granule.","other_id":"302-xxh-XLGBG","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":70,"population":"community sample and primary care clinic.","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Individuals in accordance with indications for XLGB Granule, including osteoporosis,\r\n             fracture, osteoarthritis, aseptic necrosis of bone and climacteric;\r\n\r\n          2. The age range of 18 to 70 years;\r\n\r\n          3. Individuals taking XLGB Granule over 2 weeks;\r\n\r\n          4. Abnormalities of serum liver biochemistry achieving one of the criteria as follows:\r\n\r\n             (i) alanine aminotransaminase (ALT) or aspartate transaminase (AST) 2 folds of upper\r\n             limit of normal (ULN); (ii) total bilirubin (TBiL)  2 ULN; (iii) alkaline phosphatase\r\n             (ALP)  2 ULN;\r\n\r\n          5. Individuals can provide informed consent form.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Individuals without indications for XLGB Granule;\r\n\r\n          2. Unconformity to the XLGB Granule drug label;\r\n\r\n          3. Individual taking XLGB Granule less than 2 weeks;\r\n\r\n          4. Individuals taking other hepatotoxic drugs combined with XLGB Granule, simultaneously;\r\n\r\n          5. Unconformity to the diagnostic standard for herb-induced liver injury (the Guideline\r\n             for Diagnosis and Treatment of Herb-induced Liver Injury, RPGIP-2016CN003.\r\n      ","sponsor":"Beijing 302 Hospital","sponsor_type":"Other","conditions":"Drug-Induced Liver Injury","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of XLGB Granule.","time_frame":"participants will be followed duration intake of XLGB Granule, an expected average within 8 weeks","description":"The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of XLGB Granule."},{"outcome_type":"secondary","measure":"Clinical features of early liver injuries caused by XLGB Granule assessed by serum parameters of liver function.","time_frame":"participants will be followed duration intake of XLGB Granule, an expected average of 8 weeks","description":"Clinical features of early liver injuries caused by XLGB Granule assessed by serum parameters of liver function."},{"outcome_type":"other","measure":"Disease progression of early liver injuries caused by XLGB Granule, i.e. death, liver failure, chronic DILI, recovery.","time_frame":"8 weeks","description":"Disease progression of early liver injuries caused by XLGB Granule, i.e. death, liver failure, chronic DILI, recovery."}]}
{"nct_id":"NCT02797288","start_date":"2017-03-22","enrollment":10,"brief_title":"Immune Response to FMT for C.Difficile","official_title":"Role of Eosinophils in Innate Protection From C. Difficile","primary_completion_date":"2021-12-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2022-01-31","last_update":"2021-03-16","description":"The protocol aims to address the basic mechanisms of Clostridium difficile pathogenesis by identifying how Clostridium difficile toxins inhibit eosinophils that otherwise would protect the gut from damage. This could lead to new and effective approaches to the treatment or prevention of Clostridium difficile colitis that act downstream of fecal microbiota transplants (FMT) or next generation probiotics. Successful fecal transplantation will restore Interleukin-25, Interleukin-4 and eosinophils to the colon","other_id":"18782","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":21,"population":"Adult patients receiving fecal transplant for recurrent Clostridium difficile infection\r\n        identified from the University of Virginia complicated Clostridium difficile clinic","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  one or more relapse of Clostridium difficile colitis\r\n\r\n          -  eligible for fecal microbiota transplant\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Unwilling to have biopsies for research conducted at time of FMT\r\n\r\n          -  Concurrent participation in another clinical trial, except outcome of FMT study\r\n\r\n          -  Clinical contraindication to colonoscopy, FMT, flexible sigmoidoscopy or conscious\r\n             sedation\r\n\r\n          -  Pregnancy\r\n\r\n          -  Inability to give informed consent\r\n\r\n          -  Incarceration\r\n\r\n          -  Antibiotics unless discontinued 48 hours prior to FMT\r\n\r\n          -  Celiac disease or any other form of inflammatory bowel disease\r\n\r\n          -  HIV infection\r\n\r\n          -  Neutropenia (<1000 PMNs/l blood)\r\n\r\n          -  Concurrent participation in another clinical trial, except outcome of FMT study\r\n\r\n          -  Anticoagulants if not able to discontinue 5 days prior to endoscopy and flexible\r\n             sigmoidoscopy\r\n      ","sponsor":"University of Virginia","sponsor_type":"Other","conditions":"Clostridium Difficile","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"tissue IL-25","time_frame":"0-60 days post fecal transplant"},{"outcome_type":"secondary","measure":"Tissue IL-4","time_frame":"0-60 days post fecal transplant"},{"outcome_type":"secondary","measure":"Tissue IL-1","time_frame":"0-60 days post fecal transplant"},{"outcome_type":"secondary","measure":"Tissue histology","time_frame":"0-60 days post fecal transplant"},{"outcome_type":"secondary","measure":"Tissue 16s rDNA","time_frame":"0-60 days post fecal transplant"},{"outcome_type":"secondary","measure":"Plasma metabolomics","time_frame":"0-60 days post fecal transplant"},{"outcome_type":"secondary","measure":"Tissue eosinophils","time_frame":"0-60 days post fecal transplant","description":"single-cell atomic mass spectrometry"}]}
{"nct_id":"NCT03085147","start_date":"2017-03-15","phase":"Phase 1/Phase 2","enrollment":20,"brief_title":"A Dye for the Detection of Cancer of the Tongue and Mouth","official_title":"A Phase I/II Study of the Fluorescent PARP1 Binding Imaging Agent PARPi-FL in Patients With Oral Squamous Cell Carcinomas","primary_completion_date":"2022-07-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-07-31","last_update":"2020-11-24","description":"The purpose of this study is to test if an investigational dye, called PARPi-FL, can be used to detect this type of cancer. This will be the first time that PARPi-FL is being tried in people. First, the investigators will test the safety of PARPi-FL at different doses to find out what effects, if any, it has on people. The investigators will also see which amount of PARPi-FL is best suited to detect cancers of the mouth and tongue.","other_id":"15-336","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","intervention_model_description":"This is an open label, investigator initiated single arm phase I/II study. The concentration for imaging OSCC is defined in Phase I. Phase II will then use this concentration to obtain preliminary data on the sensivity of PARPi-FL to detect and delinate OSCC.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patient is  18 years old\r\n\r\n          -  Histologically or cytologically proven squamous cell carcinoma of the oral cavity or\r\n             pharynx (OSCC)\r\n\r\n          -  Scheduled to undergo surgery at MSK\r\n\r\n          -  Any tumor stage, any N, M0\r\n\r\n          -  ECOG performance status 0 or 1\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any surgical therapy in the area of the oral cavity or pharynx within the last 2 weeks\r\n\r\n          -  Prior or ongoing treatment with a PARP1 inhibitor\r\n\r\n          -  Known hypersensitivity to Olaparib\r\n\r\n          -  Known hypersensitivity to PEG300 Eligibility criteria will be assessed by an\r\n             experienced oral surgeon, typically the Co-PI of the study.\r\n      ","sponsor":"Memorial Sloan Kettering Cancer Center","sponsor_type":"Other","conditions":"Oral Squamous Cell Carcinoma (OSCC)","interventions":[{"intervention_type":"Drug","name":"Drug: Olaparib","description":"For PARRi-FL, imaging patients will first gargle a solution of PARRi-FL for 1 min, then spit out this solution and gargle with a cleaning solution (the solvent used for PARRi-FL) for 1 min. Then fluorescence imaging of the oral cavity and pharynx will be performed with an endoscope. The intensity and extent of the fluorescence signal will be recorded by one of the investigators for the tumor and adjacent normal mucosa."}],"outcomes":[{"outcome_type":"primary","measure":"escalating levels of toxicity (CTCAE v 4.0)","time_frame":"1 year","description":"toxicity data relevant to study interventions (CTCAE v 4.0)"}]}
{"nct_id":"NCT03071575","start_date":"2017-03-09","phase":"Phase 4","enrollment":620,"brief_title":"Measles-Rubella Vaccine Immunogenicity at 6 and 9 Months of Age","official_title":"Assessing Immunogenicity of Measles-Rubella Vaccine at 6 and 9 Months of Age","primary_completion_date":"2018-03-18","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-03-18","last_update":"2020-12-30","description":"This is an open-label, randomized, 2-arm clinical trial in healthy infants in Bangladesh. The primary purpose of the study is to assess the immunogenicity of measles-rubella (MR) vaccine when delivered at 6 months. In addition, the study will establish the equality of MR vaccine seroconversion administered at 9 months following administration of an earlier MR vaccine dose at 6 months of age compared to MR vaccine dose administered at 9 months without previous MR vaccination. This study will also provide additional data on safety and tolerance of MR vaccine given at 6 months, and impact of maternal antibodies on immunogenicity of MR vaccine at 6 months. - Primary objectives: 1. To assess immunogenicity of MR vaccine at 6 months of age 2. To assess immunogenicity of MR vaccine at 9 months of age among children without prior measles and rubella vaccination, compared with MR vaccine immunogenicity among those who had a prior MR vaccination at 6 months of age - Secondary objectives 1. To assess the frequency of adverse reactions following administration of MR vaccine at 6 months 2. To compare the immunogenicity of the MR vaccine first dose administered at 6 months vs at 9 months. 3. To assess the proportion of mothers with undetectable, detectable and protective levels of measles and rubella antibodies 4. To determine the extent of variation in measles antibodies in women of child bearing age in a population with a long standing measles vaccination program 5. To determine the extent of variation in rubella antibodies in women of child bearing age in a population where rubella vaccine have been recently introduced 6. To determine if variation in antibody levels in infants at 6 months is predominately explained by variation in starting antibody levels in the mother in this population 7. To estimate the half-life of decay of measles and rubella antibodies in infants","other_id":"CDC","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":0.5,"maximum_age":0.91667,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Infants:\r\n\r\n          -  Healthy infants at 6 months (180 days, +/- 7 days) of age\r\n\r\n          -  A parent or guardian that consents for participation in the full length of the study\r\n\r\n          -  A parent or guardian that is able to understand and comply with planned study\r\n             procedures\r\n\r\n        Inclusion criteria:\r\n\r\n        Mothers:\r\n\r\n          -  Mothers of infants that meet inclusion criteria.\r\n\r\n          -  18 years of age\r\n\r\n          -  Mothers who consent to participate in the full length of the study\r\n\r\n        Exclusion Criteria:\r\n\r\n        Infants:\r\n\r\n          -  Family that is unable to participate in the full length of the study\r\n\r\n          -  A diagnosis or suspicion of immunodeficiency disorder either in the infant or mother\r\n\r\n          -  A diagnosis or suspicion of bleeding disorder that would contraindicate parenteral\r\n             administration of MR vaccine or collection of blood by venipuncture\r\n\r\n          -  Acute infection or illness at the time of enrolment (6 months ) that would require\r\n             infant's admission to a hospital\r\n\r\n          -  Receipt of any measles or rubella containing vaccine prior to enrolment (i.e., before\r\n             age 6 months) outside of study based upon documentation or parental recall\r\n\r\n          -  Known history of laboratory confirmed measles or rubella infection\r\n\r\n          -  A diagnosis of rubella infection in mother during pregnancy\r\n\r\n          -  A diagnosis of congenital rubella syndrome in infant\r\n\r\n          -  Known allergy/sensitivity or reaction to measles-rubella containing vaccine or\r\n             contents of measles-rubella containing vaccine\r\n\r\n          -  Persons with a history of an anaphylactic reaction to any components of the vaccine\r\n\r\n          -  Infants from premature births (<37 weeks of gestation)\r\n\r\n        Exclusion criteria: Mothers:\r\n\r\n          -  Refuses to give blood samples. (If the mother agrees for her child to participate in\r\n             the study, but refuses to give a blood samples herself or blood samples cannot be\r\n             obtained, the child will still be enrolled.)\r\n\r\n          -  A diagnosis or suspicion of immunodeficiency disorder\r\n\r\n          -  A diagnosis or suspicion of bleeding disorder that would contraindicate collection of\r\n             blood by venipuncture\r\n\r\n        Temporary exclusion:\r\n\r\n        Infants:\r\n\r\n          -  Acute febrile illness (38C) at the time of enrollment\r\n\r\n          -  Family will be requested to bring back the child 1-2 days later or when child feels\r\n             better.\r\n      ","sponsor":"Centers for Disease Control and Prevention","sponsor_type":"U.S. Fed","conditions":"Measles|Rubella|Rubella Syndrome, Congenital","interventions":[{"intervention_type":"Biological","name":"Biological: Measles-rubella (MR) vaccine at 6 and 9 months","description":"Arm A will receive MR vaccine dose at 6 and 9 months of age"},{"intervention_type":"Biological","name":"Biological: Measles-rubella (MR) vaccine at 9 months","description":"Arm A will receive MR vaccine dose at 9 months of age"}],"outcomes":[{"outcome_type":"primary","measure":"Seroconversion at 6 months","time_frame":"Change in antibody titers at 9 months compared to 6 months of age","description":"Measles neutralizing antibody titers (measured by plaque reduction neutralization test) and rubella titers (IU/mL) (measured by ELISA) on sera collected at 9 months of age. Seroprotection is defined as antibody level of ≥ 120 mIU/mL for measles and >10 IU/mL for rubella."},{"outcome_type":"primary","measure":"Seroconversion at 9 months","time_frame":"At 11 months of age.","description":"To assess immunogenicity of MR vaccine at 9 months of age among children without prior measles and rubella vaccination, compared with MR vaccine immunogenicity among those who had a prior MR vaccination at 6 months of age"},{"outcome_type":"secondary","measure":"Adverse Effects Following Immunization (AEFI)","time_frame":"Day 1 to Day 84","description":"To assess the frequency of adverse reactions following administration of MR vaccine at 6 months"},{"outcome_type":"secondary","measure":"Immunogenicity at 9 months","time_frame":"At 9 months and 11 months of age","description":"To compare the immunogenicity of the MR vaccine first dose administered at 6 months vs at 9 months"},{"outcome_type":"secondary","measure":"Measles and rubella titers of enrolled mothers","time_frame":"At day 1","description":"To assess the proportion of mothers with undetectable, detectable and protective levels of measles and rubella antibodies"},{"outcome_type":"secondary","measure":"Correlation of mothers' measles and rubella antibody levels with infants' maternal antibodies","time_frame":"Time from randomization to 9 and 11 months","description":"To assess the correlation between measles and rubella antibody levels in women and levels of maternal antibodies in infants"},{"outcome_type":"secondary","measure":"Half-life and decay of maternal measles and rubella antibodies.","time_frame":"Day 1 to day 84","description":"To estimate the half-life of decay of maternal measles and rubella antibodies in infants"}]}
{"nct_id":"NCT04679519","start_date":"2017-03-06","phase":"N/A","enrollment":90,"brief_title":"The Effects of Protein Supplementation in Females and Males Following Acute Eccentric Exercise","official_title":"The Effects of Protein Supplementation in Females and Males Following Acute Eccentric Exercise","primary_completion_date":"2019-03-25","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-03-25","last_update":"2021-01-06","description":"Examine the impact of the protein supplements leucine, HMB and BCAA on muscle recovery and inflammatory response following acute exercise.","other_id":"16/SPS/007","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","intervention_model_description":"Randomised control study with four groups, one control and three protein supplements.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":35,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Health recreationally active males and females.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Asthma sufferers\r\n\r\n          -  People with kidney disease\r\n\r\n          -  People partaking in lower limb strength training\r\n\r\n          -  People suffering DOMS in the past 6 months\r\n\r\n          -  People already taking dietary supplements, other NSAIDs, or for example aspirin,\r\n             alcohol, warfarin, phenytoin, methotrexate, lithium, diuretics, cyclosporine.\r\n\r\n          -  People with bone or soft tissue injury within last 12 months\r\n\r\n          -  People with gastric problems\r\n\r\n          -  People with hypertension\r\n\r\n          -  People who have had history of heart failure\r\n\r\n          -  People with liver disease\r\n\r\n          -  People with connective tissue disorders\r\n\r\n          -  People with Crohn's disease\r\n\r\n          -  People with ulcerative colitis\r\n\r\n          -  People with peripheral arterial disease\r\n\r\n          -  People with cerebrovascular disease\r\n\r\n          -  Elderly population\r\n\r\n          -  People with allergies to NSAIDs, Omega- 3 fatty acids and BCAAs.\r\n\r\n          -  People with depression\r\n\r\n          -  People with bipolar disorder\r\n\r\n          -  People with diabetes\r\n\r\n          -  Females who are pregnant\r\n\r\n          -  People who have HIV / AIDS\r\n      ","sponsor":"Liverpool John Moores University","sponsor_type":"Other","conditions":"Muscle Damage","interventions":[{"intervention_type":"Other","name":"Other: Drop Jumps","description":"Perform 100 drop jumps from 40 cm height. The protocol is divided into 5 sets of 20 repetitions. Between each repetition participants get 10 seconds, and between each set 2 minutes rest. Stand on the box, drop of the box and land with feet shoulder width apart. Then immediately bend knee to approx 45 degrees and jump straight up. Throughout each jump hands are placed on hips and should not move."}],"outcomes":[{"outcome_type":"primary","measure":"Concentration of Creatine Kinase at baseline","time_frame":"Baseline","description":"Blood taken from either vein or finger will be analysed for creatine kinase, a marker of muscle damage."},{"outcome_type":"primary","measure":"Concentration of Creatine Kinase immediately after intervention.","time_frame":"Immediately after intervention.","description":"Blood taken from either vein or finger will be analysed for creatine kinase, a marker of muscle damage."},{"outcome_type":"primary","measure":"Concentration of Creatine Kinase at 24 hours after intervention.","time_frame":"24 hours after intervention.","description":"Blood taken from either vein or finger will be analysed for creatine kinase, a marker of muscle damage."},{"outcome_type":"primary","measure":"Concentration of Creatine Kinase at 48 hours after intervention.","time_frame":"48 hours after intervention.","description":"Blood taken from either vein or finger will be analysed for creatine kinase, a marker of muscle damage."},{"outcome_type":"primary","measure":"Concentration of Creatine Kinase at 7 days after intervention.","time_frame":"7 days after intervention.","description":"Blood taken from either vein or finger will be analysed for creatine kinase, a marker of muscle damage."},{"outcome_type":"primary","measure":"Concentration of Creatine Kinase at 14 days after intervention.","time_frame":"14 days after intervention.","description":"Blood taken from either vein or finger will be analysed for creatine kinase, a marker of muscle damage."},{"outcome_type":"primary","measure":"Number of Chair Rises at baseline","time_frame":"Baseline","description":"Stand and sit on chair consecutively for 30 seconds with hands placed on hips."},{"outcome_type":"primary","measure":"Number of Chair Rises immediately after intervention.","time_frame":"Immediately after intervention.","description":"Stand and sit on chair consecutively for 30 seconds with hands placed on hips."},{"outcome_type":"primary","measure":"Number of Chair Rises at 24 hours after intervention.","time_frame":"24 hours after intervention.","description":"Stand and sit on chair consecutively for 30 seconds with hands placed on hips."},{"outcome_type":"primary","measure":"Number of Chair Rises at 48 hours after intervention.","time_frame":"48 hours after intervention.","description":"Stand and sit on chair consecutively for 30 seconds with hands placed on hips."},{"outcome_type":"primary","measure":"Number of Chair Rises at 7 days after intervention.","time_frame":"7 days after intervention.","description":"Stand and sit on chair consecutively for 30 seconds with hands placed on hips."},{"outcome_type":"primary","measure":"Number of Chair Rises at 14 days after intervention.","time_frame":"14 days after intervention.","description":"Stand and sit on chair consecutively for 30 seconds with hands placed on hips."},{"outcome_type":"primary","measure":"Squat Jump height at baseline","time_frame":"Baseline","description":"Hands placed on hips, feet shoulder width apart. Bend knees to approx 45 degrees hold for 3 seconds and jump maximally."},{"outcome_type":"primary","measure":"Squat Jump height immediately after intervention.","time_frame":"Immediately after intervention.","description":"Hands placed on hips, feet shoulder width apart. Bend knees to approx 45 degrees hold for 3 seconds and jump maximally."},{"outcome_type":"primary","measure":"Squat Jump height at 24 hours after intervention.","time_frame":"24 hours after intervention.","description":"Hands placed on hips, feet shoulder width apart. Bend knees to approx 45 degrees hold for 3 seconds and jump maximally."},{"outcome_type":"primary","measure":"Squat Jump height at 48 hours after intervention.","time_frame":"48 hours after intervention.","description":"Hands placed on hips, feet shoulder width apart. Bend knees to approx 45 degrees hold for 3 seconds and jump maximally."},{"outcome_type":"primary","measure":"Squat Jump height at 7 days after intervention.","time_frame":"7 days after intervention.","description":"Hands placed on hips, feet shoulder width apart. Bend knees to approx 45 degrees hold for 3 seconds and jump maximally."},{"outcome_type":"primary","measure":"Squat Jump height at 14 days after intervention.","time_frame":"14 days after intervention.","description":"Hands placed on hips, feet shoulder width apart. Bend knees to approx 45 degrees hold for 3 seconds and jump maximally."},{"outcome_type":"primary","measure":"Range of motion at baseline.","time_frame":"Baseline","description":"Sit on chair, then flex and extend legs three times from 90 degrees position."},{"outcome_type":"primary","measure":"Range of motion immediately after intervention.","time_frame":"Immediately after intervention.","description":"Sit on chair, then flex and extend legs three times from 90 degrees position."},{"outcome_type":"primary","measure":"Range of motion at 24 hours after intervention.","time_frame":"24 hours after intervention.","description":"Sit on chair, then flex and extend legs three times from 90 degrees position."},{"outcome_type":"primary","measure":"Range of motion at 48 hours after intervention.","time_frame":"48 hours after intervention.","description":"Sit on chair, then flex and extend legs three times from 90 degrees position."},{"outcome_type":"primary","measure":"Range of motion at 7 days after intervention.","time_frame":"7 days after intervention.","description":"Sit on chair, then flex and extend legs three times from 90 degrees position."},{"outcome_type":"primary","measure":"Range of motion at 14 days after intervention.","time_frame":"14 days after intervention.","description":"Sit on chair, then flex and extend legs three times from 90 degrees position."},{"outcome_type":"primary","measure":"Inflammatory cytokines concentration at baseline","time_frame":"Baseline","description":"Blood from vein will be analysed for 10 different cytokines. Different cytokines include interleukins 1 beta, 2, 3, 4, 7, 8, 10, 17 and tutor necrosis factor receptor 1."},{"outcome_type":"primary","measure":"Inflammatory cytokines concentration at 24 hours after intervention.","time_frame":"24 hours after intervention.","description":"Blood from vein will be analysed for 10 different cytokines. Different cytokines include interleukins 1 beta, 2, 3, 4, 7, 8, 10, 17 and tutor necrosis factor receptor 1."},{"outcome_type":"primary","measure":"Inflammatory cytokines concentration at 48 hours after intervention.","time_frame":"48 hours after intervention.","description":"Blood from vein will be analysed for 10 different cytokines. Different cytokines include interleukins 1 beta, 2, 3, 4, 7, 8, 10, 17 and tutor necrosis factor receptor 1."},{"outcome_type":"primary","measure":"Inflammatory cytokines concentration at 7 days after intervention.","time_frame":"7 days after intervention.","description":"Blood from vein will be analysed for 10 different cytokines. Different cytokines include interleukins 1 beta, 2, 3, 4, 7, 8, 10, 17 and tutor necrosis factor receptor 1."},{"outcome_type":"primary","measure":"Concentration of Lactate from baseline to immediately after intervention.","time_frame":"Baseline and immediately after intervention.","description":"Blood drop from finger will be used to lactate."},{"outcome_type":"primary","measure":"Muscle Soreness","time_frame":"Daily for 14 days.","description":"Record soreness on visual analogue scale from 1-10 1 = low soreness, 10 = extreme soreness."},{"outcome_type":"secondary","measure":"Weighed food diaries.","time_frame":"Daily for 14 days.","description":"Fill out dietary intake on food diary, by weighing food."}]}
{"nct_id":"NCT03106532","start_date":"2017-03-06","phase":"Phase 2","enrollment":119,"brief_title":"Evaluation of PHP-201 Ophthalmic Solution in Patients With Normal Tension Glaucoma","official_title":"A Multicenter, Randomized, Placebo-controlled, Double-blind, Dose-finding Phase 2 Clinical Trial to Evaluate the Efficacy in Reduction of Intraocular Pressure and Safety of PHP-201 in Patients With Normal Tension Glaucoma","primary_completion_date":"2018-05-02","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-05-02","last_update":"2018-10-26","description":"Evaluation of the optimal dose for the efficacy in reduction of intraocular pressure and safety of PHP-201 ophthalmic solution in patients with normal tension glaucoma","other_id":"PHP-201-S203","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":19,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  19 years and older, female and male\r\n\r\n          -  IOP 21 mmHg\r\n\r\n          -  Subject showing open angle finding, glaucomatous optic nerve damage and visual field\r\n             defects\r\n\r\n          -  BCVA +0.2\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subject with the disease and surgery history that are not eligible to participate\r\n             (acute closed angle glaucoma, narrow angle glaucoma, advanced glaucomatous loss,\r\n             ocular trauma, eye surgery or laser surgery, unstable angina, myocardial infarction,\r\n             uncontrolled hypertension and diabetes, etc)\r\n\r\n          -  Subject who can't discontinue contact lenses\r\n\r\n          -  Subject who can't discontinue topical/systemic IOP lowering medication\r\n      ","sponsor":"pH Pharma","sponsor_type":"Industry","conditions":"Normal Tension Glaucoma","interventions":[{"intervention_type":"Drug","name":"Drug: PHP-201 0.25% ophthalmic solution","description":"3 drops daily, 28 days"},{"intervention_type":"Drug","name":"Drug: PHP-201 0.5% ophthalmic solution","description":"3 drops daily, 28 days"},{"intervention_type":"Drug","name":"Drug: Placebo ophthalmic solution","description":"3 drops daily, 28 days"}],"outcomes":[{"outcome_type":"primary","measure":"Mean diurnal IOP change","time_frame":"4 weeks","description":"Mean diurnal IOP change from baseline at post-treatment time point of 4 weeks"},{"outcome_type":"secondary","measure":"The number of patient with adverse events","time_frame":"28 days","description":"The number of patient with adverse events including ocular adverse events"}]}
{"nct_id":"NCT02801279","start_date":"2017-03-04","phase":"N/A","enrollment":130,"brief_title":"Development of Kinect-assisted Home-based Bilateral Arm Training Program for Cerebral Palsy","official_title":"Development of Kinect-assisted Home-based Bilateral Arm Training Program for Cerebral Palsy","primary_completion_date":"2022-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-12-31","last_update":"2021-08-12","description":"The purpose of the present study is to develop a long term cost-effectiveness (efficient protocol, playful context, and practical strategy) training program for school-age children with Cerebral Palsy. Also, evaluate efficacy of Kinect-assisted bilateral arm training program for children with Cerebral Palsy.","other_id":"201503112RIND","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":6,"maximum_age":12,"population":"","criteria":"\n        The inclusion criteria of children with CP are:\r\n\r\n          1. diagnosed with congenital hemiplegic\r\n\r\n          2. no excessive muscle tone (Modified Ashworth Scale  3 at any joints of the upper limb)\r\n\r\n        The exclusion criteria of children with CP are:\r\n\r\n          1. have severe cognitive, visual, or auditory disorders according to medical documents,\r\n             parental reports, and the examiner's clinical observation\r\n\r\n          2. have injections of botulinum toxin type A.\r\n\r\n        The inclusion criteria of typically developing children are:\r\n\r\n          1. absence of medical or developmental diseases which would affect physical and cognitive\r\n             performances\r\n\r\n          2. having normal corrected vision\r\n\r\n          3. studying in regular education classroom in primary school for the 6-12 year-old\r\n             children.\r\n\r\n        The exclusion criteria of typically developing children are:\r\n\r\n        (1) having score not within normal limits in BOTMP-short form\r\n      ","sponsor":"National Taiwan University Hospital","sponsor_type":"Other","conditions":"Cerebral Palsy","interventions":[{"intervention_type":"Other","name":"Other: Conventional bilateral arm training","description":"The Kinect-based bilateral arm training focuses activities that required the use of both hands by using Kinect game."},{"intervention_type":"Other","name":"Other: Kinect-based bilateral arm training","description":"The conventional bilateral arm training focuses activities that required the use of both hands."}],"outcomes":[{"outcome_type":"primary","measure":"Performance change of Kinematic analysis","time_frame":"baseline, after 8 weeks, after 6 months"},{"outcome_type":"secondary","measure":"Change of muscle strength","time_frame":"baseline, after 8 weeks, after 6 months"},{"outcome_type":"secondary","measure":"Score change of Melbourne Assessment 2 (MA-2)","time_frame":"baseline, after 4 weeks, after 8 weeks, after 6 months"},{"outcome_type":"secondary","measure":"Score change of Pediatric Motor Activity Log-Revised (PMAL-R)","time_frame":"baseline, after 4 weeks, after 8 weeks, after 6 months"},{"outcome_type":"secondary","measure":"Score change of ABILHAND-Kids","time_frame":"baseline, after 4 weeks, after 8 weeks, after 6 months"},{"outcome_type":"secondary","measure":"Score change of Test of Playfulness (ToP)","time_frame":"baseline, after 4 weeks, after 8 weeks, after 6 months"},{"outcome_type":"secondary","measure":"Score change of Box and Block Test (BBT)","time_frame":"baseline, every week(week1 to week 8), after 4 weeks, after 8 weeks, after 6 months"},{"outcome_type":"secondary","measure":"Score change of Engagement Questionnaire (EQ)","time_frame":"baseline, after 4 weeks, after 8 weeks, after 6 months"},{"outcome_type":"secondary","measure":"Score change of Satisfactory Questionnaire (SQ)","time_frame":"baseline, after 4 weeks, after 8 weeks, after 6 months"},{"outcome_type":"secondary","measure":"Score change of Building Tower Test (BTT)","time_frame":"baseline, every week(week1 to week 8), after 4 weeks, after 8 weeks, after 6 months"},{"outcome_type":"secondary","measure":"Score change of String Beads Test (SBT)","time_frame":"baseline, every week(week1 to week 8), after 4 weeks, after 8 weeks, after 6 months"},{"outcome_type":"secondary","measure":"Score change of Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)","time_frame":"baseline, after 4 weeks, after 8 weeks, after 6 months"},{"outcome_type":"secondary","measure":"Score change of Pediatric Evaluation of Disability Inventory (PEDI)","time_frame":"baseline, after 4 weeks, after 8 weeks, after 6 months"},{"outcome_type":"secondary","measure":"Score change of Cerebral Palsy Quality of Life Questionnaire for Children (CPQOL)","time_frame":"baseline, after 4 weeks, after 8 weeks, after 6 months"},{"outcome_type":"secondary","measure":"Score change of Parenting Stress Index-Short Form (PSI-short)","time_frame":"baseline, after 4 weeks, after 8 weeks, after 6 months"},{"outcome_type":"secondary","measure":"Score change of Test of Visual Perceptual Skills","time_frame":"baseline, after 4 weeks, after 8 weeks, after 6 months"}]}
{"nct_id":"NCT02949453","start_date":"2017-03-03","phase":"N/A","enrollment":19,"brief_title":"ACCeptation and Qualitative Evaluation of Phone-delivered Intervention","official_title":"ACCeptation and Qualitative Evaluation of Phone-delivered Intervention To Prevent Suicide Reattempt","primary_completion_date":"2019-04-04","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-04-04","last_update":"2019-04-08","description":"Background: Previous suicide attempt is known to be a strong risk factor for repetition and repetition is common within the first year after an episode of deliberate self-harm (DSH). There has been growing interest in brief interventions for this population that are focused on maintaining long-term contact and/or offering re-engagement with services when needed. Despite telephone-delivered interventions have shown promising results in suicide reattempt prevention, subjective impact of such brief contact interventions and effectiveness mechanisms have never been evaluated.","other_id":"2016-A00919-42","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":90,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Deliberate self-harm in the previous week,\r\n\r\n          -  18 years old and older,\r\n\r\n          -  outpatient care orientation after discharge from emergency department\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Difficulties in french language,\r\n\r\n          -  mental retardation\r\n      ","sponsor":"Hpital le Vinatier","sponsor_type":"Other","conditions":"Suicide","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Semi-directed interview performed by a social sciences researcher","description":"Two semi-directed interviews performed by social sciences researcher:\r\nfirst interview performed 6 weeks after the suicide attempt, in an suicide prevention unit, duration 1 to 1.5 hour\r\nsecond interview performed 3 month after the suicide attempt, in a suicide prevention unit, duration 1 to 1.5 hour"}],"outcomes":[{"outcome_type":"primary","measure":"Acceptation of a telephone-delivered intervention after deliberate self-harm(DSH)","time_frame":"change from baseline after the telephone intervention","description":"analyze the acceptability for suicidal patients in the reiteration of the suicide prevention procedure performed by telephone Callback"},{"outcome_type":"secondary","measure":"Impact of telephone-delivered intervention after a deliberate self-harm (DSH)","time_frame":"2 years","description":"through the evaluation of this device Callback, we will identify its impact on pipelines and post-crisis experiences"}]}
{"nct_id":"NCT02799901","start_date":"2017-03-03","phase":"Phase 2","enrollment":72,"brief_title":"Nivolumab Plus Radiotherapy in Advanced Melanoma","official_title":"Nivolumab in Combination With High Dose Radiotherapy at Varied Tumor Sites in Advanced Melanoma and no Prior Antitumoral Treatment","primary_completion_date":"2019-03-03","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2020-11-30","last_update":"2017-08-24","description":"Combining nivolumab with conventional multisite high dose radiotherapy seems to be an interesting approach that could increase the antitumoral effect of nivolumab by increasing the diversity and quantity of tumoral antigen presentation thanks to radiotherapy. Multifractionated high dose radiotherapy (HR) targeting various tumor sites could also increase occurrence of tumor mutations and the diversity of the T-cell receptor repertoire of intratumoral T cells. The purpose of this study is to combine nivolumab with 3 fractions of HR of one metastasis for each tumor site (defined as skin/muscle, thoracic, abdomen, bone, other). The investigators hypothesize that combining nivolumab with multisite, multifractionated HR increases the overall survival rate at 1 year compared to published data with nivolumab alone.","other_id":"16-PP-02","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Willing and able to give written informed consent\r\n\r\n          2. Men and women,  18 years of age\r\n\r\n          3. Histologically confirmed Stage III (unresectable) or Stage IV melanoma. Unknown\r\n             primary melanoma will be accepted.\r\n\r\n          4. Measurable disease by CT per RECIST 1.1 criteria\r\n\r\n          5. Indication of radiotherapy\r\n\r\n          6. Patient MUST be untreated for his/her Stage III (unresectable) or Stage IV melanoma\r\n\r\n          7. Prior treatment with INTERFERON in the adjuvant setting is authorized.\r\n\r\n          8. BRAF status must be determinate but patient will be eligible regardless the status\r\n             (BRAF wildtype and BRAF V600 mutation positive patients could be included)\r\n\r\n          9. A pre-treatment recent core, excision or punch biopsy must be provided for PD-L1\r\n             status determination prior to start the treatment and for exploratory biomarker\r\n             analyses. The biopsy must be from an unresectable or metastatic site, and the subject\r\n             must have had no intervening systemic therapy between the time of biopsy and the start\r\n             of inclusion\r\n\r\n         10. Patient must consent to allow the acquisition of existing formalin-fixed\r\n             paraffin-embedded (FFPE) material (\" archival \") (block or a minimum of 10 unstained\r\n             slides) if available, for performance of correlatives studies\r\n\r\n         11. Subjects must consent to allow the acquisition of blood samples: one during the week\r\n             before the first nivolumab injection; the second 15 days +- 2 days after the first\r\n             injection of nivolumab; the third between 15 and 30 days after the first radiotherapy\r\n             session and the fourth at relapse, for performance of correlative studies,\r\n\r\n         12. Eastern Cooperative Oncology Group (ECOG) Performance Status 1\r\n\r\n         13. Within the last 2 weeks prior to study day 1 the following laboratory parameters,\r\n             which should be within the ranges specified:\r\n\r\n         14. Subjects affiliated to an appropriate social security system NB: Patients will be\r\n             included regardless of the level of LDH.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. The patient requires concomitant chronic treatment with systemic corticosteroids or\r\n             any other immunosuppressive agents 7 days prior to inclusion,\r\n\r\n          2. Patient with brain(s) metastase(s), symptomatic(s) or not,\r\n\r\n          3. Ocular or mucosal melanoma (unknown primary melanoma will be accepted),\r\n\r\n          4. The patient has concurrent severe medical problems, unrelated to the malignancy, that\r\n             would significantly limit full compliance with the study or expose the patient to\r\n             unacceptable risk such as but not limited to: Cardiac insufficiency (III or IV as per\r\n             NYHA classification), Renal insufficiency, ongoing infection,\r\n\r\n          5. Subjects with previous malignancies (except non-melanoma skin cancers, in situ bladder\r\n             cancer, gastric or colon cancers, cervical cancers/dysplasia or breast carcinoma in\r\n             situ) are excluded unless a complete remission was achieved at least 2 years prior to\r\n             study entry and no additional therapy is required or anticipated to be required during\r\n             the study period,\r\n\r\n          6. Uncontrolled infectious diseases - requires negative tests for clinically suspected\r\n             HIV, hepatitis B virus (HBV) and hepatitis C virus (HCV). If positive results are not\r\n             indicative of true active or chronic infection, the subject may enter the study after\r\n             discussion and agreement between the Investigator and the Medical Monitor,\r\n\r\n          7. Active Autoimmune disease: subjects with a documented history of inflammatory bowel\r\n             disease, including ulcerative colitis and Crohn's disease are excluded from this study\r\n             as are subjects with a history of symptomatic disease (e.g., rheumatoid arthritis,\r\n             systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus, autoimmune\r\n             vasculitis [e.g., Wegener's Granulomatosis]); subjects with vitiligo, type I diabetes\r\n             mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone\r\n             replacement, psoriasis not requiring systemic treatment, or conditions not expected to\r\n             recur in the absence of an external trigger are permitted to enroll,\r\n\r\n          8. Subjects with motor neuropathy considered of autoimmune origin (e.g., Guillain Barre\r\n             Syndrome) are excluded from this study,\r\n\r\n          9. Previous treatment with, chemotherapy, a CTLA-4 or PD-1/PD-L1 antagonist agent,\r\n             including treatment in adjuvant setting for immunotherapy,\r\n\r\n         10. The patient has psychiatric or addictive disorders that may compromise his/her ability\r\n             to give informed consent or to comply with the trial procedures,\r\n\r\n         11. Lack of availability for clinical follow-up assessments,\r\n\r\n         12. Pregnant or lactating women (a blood pregnancy test will be conducted) and effective\r\n             contraception will be used throughout the treatment for women of childbearing age,\r\n\r\n         13. Participation in another clinical trial protocol within 30 days prior to enrolment,\r\n\r\n         14. Persons protected by a legal regime (guardianship, trusteeship),\r\n\r\n         15. Vulnerable patients, patients kept in detention\r\n      ","sponsor":"Centre Hospitalier Universitaire de Nice","sponsor_type":"Other","conditions":"Melanoma","interventions":[{"intervention_type":"Biological","name":"Biological: Nivolumab","description":"Injection of nivolumab"},{"intervention_type":"Radiation","name":"Radiation: hypofractionned radiotherapy","description":"radiation"}],"outcomes":[{"outcome_type":"secondary","measure":"the rate of progression-free survival","time_frame":"at 6 months"},{"outcome_type":"secondary","measure":"the rate of progression-free survival","time_frame":"at 1 year"},{"outcome_type":"secondary","measure":"the rate of progression-free survival","time_frame":"at 2 years"},{"outcome_type":"secondary","measure":"Global progression free survival (PFS) rate","time_frame":"at 6 months"},{"outcome_type":"secondary","measure":"Global progression free survival (PFS) rate","time_frame":"at 1 year"},{"outcome_type":"secondary","measure":"Global progression free survival (PFS) rate","time_frame":"at 2 years"},{"outcome_type":"secondary","measure":"global PFS rate","time_frame":"at 6 months"},{"outcome_type":"secondary","measure":"global PFS rate","time_frame":"at 1 year"},{"outcome_type":"secondary","measure":"global PFS rate","time_frame":"at 2 year"},{"outcome_type":"secondary","measure":"overall survival","time_frame":"at 2 years"},{"outcome_type":"secondary","measure":"disease control rate (DCR)","time_frame":"at 2 years"},{"outcome_type":"secondary","measure":"predictive factors for response","time_frame":"at 2 years"},{"outcome_type":"primary","measure":"overall survival","time_frame":"1 year","description":"to increase the overall survival rate at 1 year with the combination of nivolumab and radiotherapy compared to nivolumab alone for patients with advanced melanoma"}]}
{"nct_id":"NCT04486430","start_date":"2017-03-02","phase":"Phase 2","enrollment":236,"brief_title":"Efficacy and Safety Study of Neu2000KWL for Acute Ischemic Stroke Patients Within 6 Hours of Onset","official_title":"A Phase II, Double-blind, Randomized, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of the Salfaprodil for Injection in Patients With Acute Ischemic Stroke","primary_completion_date":"2019-06-12","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-12-13","last_update":"2020-07-24","description":"The purpose of the study is to explore safety and efficacy of Salfaprodil administration for patients with acute ischemic stroke within 6 hours of onset.","other_id":"YWZC-PLJY0125","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":35,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. patients aged between 35 and 75 years;\r\n\r\n          2. acute ischemic stroke patients in internal carotid artery system within 6 hours of\r\n             onset;\r\n\r\n          3. patients with NIHSS scores of 4 to 22 and limb weakness including motor arm or motor\r\n             leg score 2 of NIHSS;\r\n\r\n          4. patients within 6 hours of onset or the last time known to be symptom free (within 6\r\n             hours of the start of sleep for ischemic stroke patients with onset during sleep), and\r\n             who receive a CT test before the clinical study;\r\n\r\n          5. Informed consent should be signed from the patient or patient's legally authorized\r\n             representative;\r\n\r\n          6. patients with premorbid mRS score of 0~1;\r\n\r\n          7. patients with no history of myocardial infarction within last 3 months;\r\n\r\n          8. patients with no heart, liver, kidney and lung function deficit;\r\n\r\n          9. patients with no hemorrhagic diseases within last 3 months;\r\n\r\n         10. patients with no haematological diseases.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Any contraindication to CT and MRI (e.g., metal implants such as pacemakers,\r\n             claustrophobia);\r\n\r\n          2. Stroke caused by posterior circulation ischemia, or transient ischemic attack (TIA);\r\n\r\n          3. Acute intracranial hemorrhage, intracranial neoplasm, cobweb hemorrhage, cerebritis or\r\n             other non-acute ischemic stroke and cerebral arteriovenous malformation;\r\n\r\n          4. Endovascular treatment within 6 hours of onset, such as mechanical embolectomy, stent\r\n             angioplasty or arteriovenous bridge treatment;\r\n\r\n          5. Pregnant or lactating women. Note: the pregnancy test of fertile women must be\r\n             negative before randomization into groups, and female patients must take appropriate\r\n             contraceptive methods at least for 3 weeks prior to the clinical study and over the\r\n             next 7 days following the last injection of test drugs;\r\n\r\n          6. Pre-existing medical, neurologic, or psychiatric diseases that would confound the\r\n             neurologic, functional, or imaging evaluations, such as persistent deficit from\r\n             previous ischemic stroke;\r\n\r\n          7. Malignant tumor or other critical disease;\r\n\r\n          8. Patients with a history of epilepsy or undergoing seizure on onset of the ischemic\r\n             stroke\r\n\r\n          9. A history of intracranial hemorrhage;\r\n\r\n         10. Patients with low blood pressure, or showing blood pressure lower than 90/60mmHg in\r\n             three consecutive times after admission;\r\n\r\n         11. A history of severe injury and surgical operation within the last 3 months;\r\n\r\n         12. Consciousness disorder as defined as \"NIHSS Ia score 2 \";\r\n\r\n         13. Complete atrioventricular block bradycardia;\r\n\r\n         14. Cardiac function rating above II level according to the New York heart association\r\n             (NYHA) grade of cardiac function, history of congestive heart failure (CHF);\r\n\r\n         15. With primary liver and kidney disease, AST or ALT 2 times greater than upper normal\r\n             limit, serum creatinine >2.0 mg/dL or >176.8 mol/L;\r\n\r\n         16. International normalized ratio (INR) > 1.7 or current use of oral anticoagulants,\r\n             except aspirin, clopidogrel, subcutaneous heparin or warfarin;\r\n\r\n         17. With bleeding tendency disease (such as hemophilia), partial thromboplastin time (PTT)\r\n             > 3 the upper limit of normal;\r\n\r\n         18. A history of, or known current problems with, drug or alcohol abuse;\r\n\r\n         19. A irritability experience of the study drugs or drugs with similar chemical\r\n             structures;\r\n\r\n         20. Participation in other clinical trials or studies before this study within the last 3\r\n             months;\r\n\r\n         21. Researchers consider that patients don't suit for the study.\r\n\r\n         22. Hepatitis B and C, HIV-positive patients\r\n\r\n        Imaging exclusion criteria:\r\n\r\n          1. patients with high density lesions associated with haemorrhage on CT scan after\r\n             admission;\r\n\r\n          2. patients with significant lower density lesions of 1/3 middle cerebral artery on CT\r\n             scan after admission;\r\n\r\n          3. patients with intracranial parenchymal tumors on CT scan after admission.\r\n      ","sponsor":"Beijing Tiantan Hospital","sponsor_type":"Other","conditions":"Stroke|Cerebral Infarction","interventions":[{"intervention_type":"Drug","name":"Drug: Neu2000KWL","description":"1st infusion of 500mg in patients within 6 hours following ischemic stroke onset followed by 9 consecutive infusions of 250 mg at intervals of 12 hours"},{"intervention_type":"Drug","name":"Drug: Neu2000KWL","description":"1st infusion of 750mg in patients within 6 hours following ischemic stroke onset followed by 9 consecutive infusions of 500 mg at intervals of 12 hours"},{"intervention_type":"Drug","name":"Drug: Neu2000KWL","description":"1st infusion of 1500mg in patients within 6 hours following ischemic stroke onset followed by 9 consecutive infusions of 500 mg at intervals of 12 hours"},{"intervention_type":"Drug","name":"Drug: Placebos","description":"1st infusion of the same volume of saline in patients within 6 hours following ischemic stroke onset followed by 9 consecutive infusions of the same volume of saline at intervals of 12 hours"}],"outcomes":[{"outcome_type":"primary","measure":"The ratio of patients with NIHSS score of 0-1 or with reduction of NIHSS score of ≥4 than the baseline on 14 ± 2 day following the first injection.","time_frame":"days:14±2","description":"The ratio of patients with NIHSS score of 0-1 or with reduction of NIHSS score of ≥4 than the baseline on 14 ± 2 day following the first injection."},{"outcome_type":"secondary","measure":"Change from the baseline in NIHSS score on 14 ± 2, 30 ± 2 and 90 ± 7 days following the first injection. 1. Change from the baseline in NIHSS score on 14 ± 2, 30 ± 2 and 90 ± 7 days following the first injection.","time_frame":"days 14±2, 30±2 and 90±7","description":"Change from the baseline in NIHSS score on 14 ± 2, 30 ± 2 and 90 ± 7 days following the first injection."},{"outcome_type":"secondary","measure":"Change from the baseline in mRS score on 14 ± 2, 30 ± 2 and 90 ± 7 days following the first injection.","time_frame":"days 14±2, 30±2 and 90±7","description":"Change from the baseline in mRS score on 14 ± 2, 30 ± 2 and 90 ± 7 days following the first injection."},{"outcome_type":"secondary","measure":"Change from the baseline in Barthel Index (BI) score on 14 ± 2, 30 ± 2 and 90 ± 7 days following the first injection.","time_frame":"days 14±2, 30±2 and 90±7","description":"Change from the baseline in Barthel Index (BI) score on 14 ± 2, 30 ± 2 and 90 ± 7 days following the first injection."},{"outcome_type":"other","measure":"Exploratory Imaging Analysis for Infarct Measurement","time_frame":"day 6±1","description":"Change in infarct volume of the patient measured with MRI prior to the first injection of Neu2000KWL (baseline) and 6 ± 1 day following the first injection."}]}
{"nct_id":"NCT02656433","start_date":"2017-03-01","phase":"N/A","enrollment":50,"brief_title":"tES With Random Noise Stimulation Applied to Children With Brain Injury","official_title":"Transcranial Noninvasive Brain Stimulation With Random Noise for Children With Congenital or Acquired Brain Injury","primary_completion_date":"2017-09-13","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2017-12-28","last_update":"2017-09-18","description":"50 children between 4 and 7 years old with moderate to severe motor impairment, 50% males 50% females will participate in an interventional study in two groups: placebo and experimental group. Placebo group will only receive traditional treatment with physiotherapy and the Experimental or tRNS Group will receive physiotherapy plus tRNS BrainNoninvasive Stimulation.","other_id":"TRNS23062015","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":3,"maximum_age":7,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients between 3 and 7 years.\r\n\r\n          -  Meet criteria for Congenital or Acquired Brain Injury .\r\n\r\n          -  Patients who have been diagnosed at least 1 year before inclusion in the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Acute visual or hearing loss.\r\n\r\n          -  Other neurological disorders: migraine, epilepsy, tuberous sclerosis\r\n\r\n          -  Other neurodevelopmental disorders like ASD, ADHD, PDD, etc ...\r\n      ","sponsor":"Spanish Foundation for Neurometrics Development","sponsor_type":"Other","conditions":"Brain Injury|Motor Skills Disorders","interventions":[{"intervention_type":"Device","name":"Device: Transcranial Random Noise Stimulation","description":"A special Helmet supply weak electrical currents in the head"},{"intervention_type":"Other","name":"Other: Physiotherapy","description":"Standard of care physiotherapy aimed to the motor impairment the subject presents"}],"outcomes":[{"outcome_type":"secondary","measure":"Differences in Power Fast Fourier Transformation before and after intervention","time_frame":"up to five months","description":"Changes in Power in EEG over different electrodes"},{"outcome_type":"primary","measure":"Gross Motor Function Measure (GMFM) as measured by the Gross Motor Function scale","time_frame":"Up to five months","description":"Motor Functionality Scale"}]}
{"nct_id":"NCT03505814","start_date":"2017-03-01","phase":"N/A","enrollment":126,"brief_title":"Interest of High Flow Nasal Cannula Oxygen Therapy in Pediatric Intensive Care Unit","official_title":"Does High Flow Nasal Cannula Oxygen Therapy Prevent Reintubation in Pediatric Surgical Intensive Care Unit","primary_completion_date":"2018-08-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-02-28","last_update":"2018-04-23","description":"monocentric randomized controlled trial starting from Mars 2017, recruitment is still ongoing. Patients aged between 0-45 days needing mechanical ventilation (MV) with tracheal intubation were included random assignation in two groups for post-extubation management: Group Optiflow (GO) for patients receiving High Flow Nasal Cannula Oxygen Therapy HNFC and Control Group (CG) for conventional treatment. Patients were evaluated during the first 72h following extubation. Primary endpoint was the incidence of reintubation. Secondary endpoints were incidence of post-extubation respiratory failure, time to reintubate and weaning time from oxygen. Respiratory and hemodynamic parameters were assessed and compared between the two groups upon extubation, after 2 hours (H2), at H6, H12, H24, H36, H48 and H72. Length of stay (LOS) and mortality were also estimated.","other_id":"HEBechirHamza","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"Double","sampling_method":"","gender":"All","maximum_age":0.12329,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  need for mechanical ventilation\r\n\r\n          -  tracheal intubation\r\n\r\n          -  surgical intensive care admission\r\n\r\n          -  availability of extubation criteria\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  prior extubation and mechanical ventilation to the actual episode\r\n\r\n          -  weaning failure due to neurological status\r\n      ","sponsor":"Hpital d'enfants Bchir-Hamza","sponsor_type":"Other","conditions":"Weaning Failure","interventions":[{"intervention_type":"Device","name":"Device: High Flow Nasal Cannula Oxygen therapy (OPTIFLOW)","description":"High flow and humidified oxygen support for new borns and young infants for post-extubation care"},{"intervention_type":"Device","name":"Device: Conventional oxygen therapy","description":"conventional oxygen support for new born and young infants in post-extubation care"}],"outcomes":[{"outcome_type":"primary","measure":"reintubation rate","time_frame":"72 hours following prior weaning and extubation","description":"need for mechanical ventilation support with tracheal intubation"},{"outcome_type":"secondary","measure":"incidence of post-extubation respiratory failure","time_frame":"72 hours following prior weaning and extubation","description":"respiratory failure"},{"outcome_type":"secondary","measure":"time to reintubate","time_frame":"72 hours following prior weaning and extubation","description":"time between first extubation and reintubation"},{"outcome_type":"secondary","measure":"weaning time from oxygen.","time_frame":"72 hours following prior weaning and extubation","description":"time to wean from any oxygen supply"},{"outcome_type":"secondary","measure":"blood pressure","time_frame":"72 hours following prior weaning and extubation","description":"blood pressure"},{"outcome_type":"secondary","measure":"heart rate","time_frame":"72 hours following prior weaning and extubation","description":"heart rate"},{"outcome_type":"secondary","measure":"respiratory rate","time_frame":"72 hours following prior weaning and extubation","description":"respiratory rate"},{"outcome_type":"secondary","measure":"SpO2/FiO2","time_frame":"72 hours following prior weaning and extubation","description":"pulsed oxygen saturation and inspired fraction of oxygen ratio"}]}
{"nct_id":"NCT03444051","start_date":"2017-03-01","enrollment":68,"brief_title":"Comparison of Two Endoscopic Biopsic Needles for Pancreatic Tumors","official_title":"Comparison of the 20-gauge Procore and 22-gauge Acquire Needles for Endoscopic Ultrasound-guided Fine Needle Biopsy (EUS-FNB) of Solid Pancreatic or Peripancreatic Masses: an Observational Study.","primary_completion_date":"2017-12-01","study_type":"Observational","rec_status":"Completed","completion_date":"2017-12-15","last_update":"2018-02-23","description":"This observational study compared quality of histological sampling of pancreatic EUS-FNB with the 20-gauge Procore and 22-gauge Acquire needles. In total, 68 patients were recruited. Histological diagnosis was achieved and a histological core biopsy was obtained in 82% of patients (28/34) in the 20-gauge Procore group and 97% of patients (33/34) in the 22-gauge Acquire group (P=0.1). Core biopsy specimens obtained were significantly longer with the 22-gauge Acquire needle with a mean cumulative length of tissue core biopsies per needle pass of 4,333,46mm vs. 7,94,35mm for the 20-gauge Procore (P<0,01). Reproducibility of this simple histological criterion was validated in intra and inter-observer.","other_id":"Mousquetaires","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"All consecutive patients 18 who were referred for EUS-FNB for solid pancreatic or\r\n        peripancreatic mass were included. The use of EUS-FNB needle was determined during EUS if\r\n        the examination confirmed the presence of a pancreatic or peri-pancreatic\r\n        non-hyper-vascular mass (on Doppler examination).\r\n\r\n        According to the period of admission, the 20-gauge Procore (Wilson Cook Medical,\r\n        Winston-Salem, NC) and 22-gauge Acquire needles (Boston Scientific Natick, MA) were\r\n        alternatively available depending on the order (made in batches of 5 units). So, patients\r\n        were included either in the 20-gauge Procore group or the 22-gauge Acquire group.\r\n\r\n        Patients could be switched via a crossover procedure to a second EUS-FNB with the\r\n        competitive needle if the first one failed to give histologic mass characterization:\r\n        failure was recorded to the first needle group, and the second EUS-FNB performed with the\r\n        alternate needle was recorded in the other group.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  All consecutive patients 18 who were referred for EUS-FNB for solid pancreatic or\r\n             peripancreatic mass were included\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  non-accessible pancreatic mass because of history of Billroth II or Roux-en-Y\r\n             reconstruction\r\n\r\n          -  coagulation disorders (such as partial thromboplastin time >42 seconds, prothrombin\r\n             time [Quick value] <50%, platelet count <50 000/mm), treatment with clopidogrel,\r\n             pregnancy.\r\n\r\n          -  patients <18 years of age\r\n      ","sponsor":"Socit Franaise d'Endoscopie Digestive","sponsor_type":"Other","conditions":"Pancreatic Tumor|Puncture","interventions":[{"intervention_type":"Procedure","name":"Procedure: EUS-FNB with 20-gauge Procore needle","description":"Puncture of a pancreatic or peripancreatic mass under Endoscopic Ultrasonography, with a 20-gauge Procore needle"},{"intervention_type":"Procedure","name":"Procedure: EUS-FNB with 22-gauge Acquire needle","description":"Puncture of a pancreatic or peripancreatic mass under Endoscopic Ultrasonography, with a 22-gauge Acquire"}],"outcomes":[{"outcome_type":"primary","measure":"pancreatic mass anatomopathological characterization","time_frame":"in the 7 days after procedure","description":"pancreatic mass anatomopathological characterization, presence of histological sampling and cumulative length of tissue core biopsies per needle pass."}]}
{"nct_id":"NCT03076125","start_date":"2017-03-01","phase":"N/A","enrollment":116,"brief_title":"Stroke COunseling for Risk REduction","official_title":"Stroke Counseling for Risk Reduction in Young Adult African Americans","primary_completion_date":"2017-12-20","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-12-20","last_update":"2018-12-13","description":"The purpose of this study is to test the efficacy of the Stroke Counseling for Risk Reduction (SCORRE) intervention in increasing accuracy of perceived stroke risk and promoting lifestyle behavior change to reduce stroke risk in young adult African Americans.","other_id":"K01NR015494","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","intervention_model_description":"randomized controlled two-group pre-post test design","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":35,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  self-identify as African American/Black\r\n\r\n          -  age 20-35 years\r\n\r\n          -  able to complete two study visits lasing 1 1/2- 2 hours and a brief daily diary for 8\r\n             weeks\r\n\r\n          -  has a cell phone or email address to receive weekly reminders and tips\r\n\r\n          -  has at least one modifiable risk factor for stroke identified during study visit one\r\n             screening\r\n      ","sponsor":"Georgia State University","sponsor_type":"Other","conditions":"Stroke","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: SCORRE","description":"3 components based on the Health Belief Model"},{"intervention_type":"Behavioral","name":"Behavioral: Attention-Control Activity","description":"sexual health education"}],"outcomes":[{"outcome_type":"primary","measure":"Accuracy of perceived stroke risk","time_frame":"immediately post-intervention","description":"Comparison of perceived versus actual stroke risk"},{"outcome_type":"primary","measure":"Targeted health behaviors","time_frame":"8 weeks","description":"Improvements in targeted health behavior (physical activity, diet, or cigarette smoking)"}]}
{"nct_id":"NCT03255265","start_date":"2017-03-01","enrollment":950,"brief_title":"Clinical Study of Microchimerism and cfDNA as Biomarkers for Acute Rejection After Organ Transplantation","official_title":"Microchimerism and cfDNA as Biomarkers for Acute Rejection After Organ Transplantation","primary_completion_date":"2021-09-28","study_type":"Observational","rec_status":"Recruiting","completion_date":"2021-12-31","last_update":"2017-08-21","description":"Organ transplantation has become an effective therapy for patients with end-stage organ failure at present. Rejection is still the most common cause of early dysfunction after organ transplantation. A large number of experimental and clinical data are suggesting that the formation of microchimer can successfully achieve donor-specific immune tolerance after transplantation. The formation of microchimerism may be one of the long-term survival mechanisms of transplantation, and the detection of microchimerism after transplantation can effectively predict the rejection of grafts. Scientists from Stanford University in the United States continued to report in 2014 and 2015 that using a new generation of high-throughput sequencing technology (NGS) to detect the level of free DNA from donor in blood plasma of recipients after cardiac and lung transplantation. The investigators found the level of free DNA in donor significantly increased when acute or chronic rejection happens, thus it may be used as a reflection of rejection or graft injury markers. It has been reported that microchimerization and donor free DNA levels are associated with rejection after organ transplantation, but these studies are mostly based on a small number of cases and the results of which re qualitative and can not provide a specific microchimerization rate due to limited detection techniques. Therefore, in order to clarify the role of microchimerism and the level of cell-free DNA in donor in organ transplantation tolerance, it is necessary to use a new generation of detection technology for multi-center study with large samples. Clinical trial was used to evaluate the clinical prediction and diagnostic value of microchimerization rate and donor cfDNA for acute rejection after organ transplantation. 950 cases of organ transplantation, of which 600 cases of renal transplantation, 300 cases of liver transplantation and 50 cases of lung transplantation.8 ml peripheral blood was collected in 1 tubes with EDTA anticoagulation. The timing of the collection was as follows: Patients with routine treatment after transplantation were preformed once every one weeks for one months and then every 3 month until the one year. In case of acute rejection, the additional blood was collected once on the day of diagnosis, and once after the treatment remission. All the samples were detected for microchimerism and cfDNA.","other_id":"cf-DNA","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":70,"population":"aged above 18 years old single organ transplant patients (first or again); Guardian or\r\n        self-signed informed consent.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Single-organ transplant recipients aged above 18 years old Recipients of re-do organ\r\n             transplants\r\n\r\n          -  Recipients with no systemic acute or chronic infections, infectious diseases;\r\n\r\n          -  Recipients with no severe systemic diseases and/or spiritual system diseases\r\n\r\n          -  Recipients or families signed the consent form.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Organ transplant recipients whose donor is child (under the age of 18 years old)\r\n\r\n          -  Patients wait-listed for multiple organ transplantation\r\n\r\n          -  Unable or unwilling to follow up regularly\r\n      ","sponsor":"Fuzhou General Hospital","sponsor_type":"Other","conditions":"Organ Transplant Rejection","interventions":[{"intervention_type":"Other","name":"Other: no interventions","description":"no interventions"}],"outcomes":[{"outcome_type":"primary","measure":"Quantification of the donor microchimerism in recipients was conducted once a week for 1 month and then at 3, 6 and 12 months after transplantation.","time_frame":"2017.4.1-2021.4.31","description":"Around the 8mL peripheral whole blood was collected and the DNA in hemocytes was extracted for qPCR analysis. During which 30 target genomic genes were amplified, the donor microchimerism rate was quantified by former differentiating of InDel sites between the donor and the recipient."},{"outcome_type":"secondary","measure":"Quantification of the donor derived cfDNA rate in recipients was conducted once a week for 1 month and then at 3, 6 and 12 months after transplantation.","time_frame":"2017.4.1-2021.4.31","description":"Around the 8mL peripheral whole blood was collected and the plasma was separated for following next-generation-sequencing by Illumina system (USA). The genotyping of the donor and the recipient"}]}
{"nct_id":"NCT03015987","start_date":"2017-02-28","phase":"N/A","enrollment":44,"brief_title":"Effect of Diode Laser Activated Irrigation Versus Ultrasonic on Post-Operative Pain in Single Visit of Necrotic Teeth","official_title":"The Effect of Diode Laser Activated Irrigation Versus Ultrasonic Activated Irrigation on Post-Operative Pain in Single Visit Endodontic Treatment of Asymptomatic Necrotic Teeth: A Randomized Controlled Trial","primary_completion_date":"2018-01-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2018-02-28","last_update":"2017-01-11","description":"the investigator intended to study the effect of laser versus ultrasonic in activation of irrigation in post operative pain of patients have a symptomatic necrotic teeth","other_id":"laser_ultrasonic","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Asymptomatic necrotic single rooted single canal teeth with or without chronic\r\n             periradicular lesion.\r\n\r\n          -  Teeth with mature root\r\n\r\n          -  Teeth without calcified root canals\r\n\r\n          -  Teeth without root caries\r\n\r\n          -  Teeth without internal or external root resorption\r\n\r\n          -  Teeth with no sign of crack formation\r\n\r\n          -  Teeth without anatomic abnormalities\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnant or lactating females\r\n\r\n          -  Teeth with vital pulp\r\n\r\n          -  Non- restorable teeth\r\n\r\n          -  Medically compromised patients\r\n\r\n          -  Patients with facial swelling or acute infection.\r\n\r\n          -  Previously endodontically treated teeth\r\n\r\n          -  periodontally affected teeth\r\n      ","sponsor":"Cairo University","sponsor_type":"Other","conditions":"Necrosis","interventions":[{"intervention_type":"Other","name":"Other: diode laser activated irrigation","description":"diode laser became the most common and affordable type of laser used in endodontics for many uses , its disinfection effect is an important issue which not discussed in clinical trial before , So this study is assigned to study that"}],"outcomes":[{"outcome_type":"primary","measure":"post operative pain","time_frame":"up to 1 week","description":"intensity of post operative pain will be measured using a numerical rating (NRS)scale"}]}
{"nct_id":"NCT02993965","start_date":"2017-02-21","phase":"N/A","enrollment":77716,"brief_title":"State Immunization Information Systems to Improve HPV Vaccination Rates","official_title":"State Immunization Information Systems to Improve HPV Vaccination Rates","primary_completion_date":"2019-03-15","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-07-31","last_update":"2020-08-20","description":"The overarching goal of this study is to evaluate the effectiveness, cost-effectiveness and sustainability of utilizing statewide Immunization Information Systems (IIS) to conduct centralized reminder/recall (R/R) to improve Human Papiloma Virus (HPV) vaccination rates among adolescents ages 11-17 (with a more focused look at the new two dose series for 11-14 year olds).","other_id":"15-1560","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":11,"maximum_age":17,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  11 through 17 years of age (trial 1)\r\n\r\n          -  11 through 14 years of age (trial 2)\r\n\r\n          -  defaulted to our selected clinics within CIIS\r\n\r\n          -  is either due for an HPV dose at baseline according to Advisory Committee on\r\n             Immunization Practices (ACIP) guidelines, or\r\n\r\n          -  has initiated but not yet completed the HPV series at baseline\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Has completed the HPV vaccine series according to Advisory Committee on Immunization\r\n             Practices (ACIP) guidelines\r\n\r\n          -  Any child whose parents have requested removal from the immunization registry\r\n      ","sponsor":"University of Colorado, Denver","sponsor_type":"Other","conditions":"Vaccine|Human Papiloma Virus Vaccine|HPV Vaccine|Immunization|Health Registry|Adolescent Health|Reproductive Health|Preventive Health Services","interventions":[{"intervention_type":"Other","name":"Other: Vaccine Reminder/Recall","description":"The investigators will be sending recall notices via phone call or postcard to 11-17 year olds or 11-14 year olds who are eligible but lacking HPV vaccine doses recorded in the Colorado Immunization Information System (CIIS). The investigators will be testing the effectiveness and cost effectiveness of up to 3 notices per dose with usual care (no intervention) for bringing children 11-17 years old up to date on HPV vaccination. They will also be testing the effectiveness and cost effectiveness of using mail vs. phone call reminder notices (as compared to no intervention) for bringing 11-14 year olds up to date on HPV vaccination."}],"outcomes":[{"outcome_type":"primary","measure":"Initiation of the HPV vaccine series (receipt and documentation of initial dose of vaccine series within immunization registry)","time_frame":"5 months","description":"Did the adolescent initiate the HPV vaccine series? The investigators are allowing up to 5 months after the initial recall notice for the adolescent to make an appointment and receive their dose. After that time frame, the investigators will not attribute vaccination to the recall. Receipt will be documented by providers within the state immunization registry via EMR direct transfer or manual entry."},{"outcome_type":"primary","measure":"Completion of the HPV vaccine series (receipt and documentation of final dose of vaccine series within immunization registry)","time_frame":"5 months","description":"Did those eligible to complete the HPV vaccine series within the time frame of the study do so? The investigators are allowing up to 5 months after the initial recall notice for the adolescent to make an appointment and receive their dose. After that time frame, the investigators will not attribute vaccination to the recall. Receipt will be documented by providers within the state immunization registry via EMR direct transfer or manual entry."},{"outcome_type":"secondary","measure":"Differences between arms - initiation","time_frame":"5 months","description":"Is 1, 2, or 3 reminders per arm most effective and cost effective for initiation. Only those who need an initial dose at baseline will be eligible for this outcome. Adolescents in each arm will be allowed up to 5 months after the first recall notice to get a vaccine. Receipt will be documented by providers within the state immunization registry via EMR direct transfer or manual entry. This will be tested in the 11-17 year old group."},{"outcome_type":"secondary","measure":"Differences between arms - completion","time_frame":"20 months","description":"Is 1, 2, or 3 reminders per arm most effective and cost effective for completion. Because the second or third dose of the series is dependent on when the adolescent receives their initial dose, the investigators will be following eligible adolescents for 20 months to allow time for those who did not respond to the recall for the initial dose right away to be able to complete the series within the time frame. However, receipt of the completion dose will only be attributed to the recall if it was received within 5 months of the 1st recall for the completion dose. Receipt will be documented by providers within the state immunization registry via EMR direct transfer or manual entry. This will be tested in the 11-17 year old group. For 11-14 year olds, completion is 2 doses. For 15-17 year olds, completion is 3 doses."},{"outcome_type":"secondary","measure":"Differences between modalities - initiation","time_frame":"5 months","description":"Are mail or phone reminders most effective and cost effective for initiation. Only those who need an initial dose at baseline will be eligible for this outcome. Adolescents in each arm will be allowed up to 5 months after the first recall notice to get a vaccine. Receipt will be documented by providers within the state immunization registry via EMR direct transfer or manual entry. This will be tested with the 11-14 year old group only."},{"outcome_type":"secondary","measure":"Differences between modalities - completion","time_frame":"5 months","description":"Are mail or phone reminders most effective and cost effective for completion. This will be tested only in the 11-14 year old group, so completion will equal 2nd dose. Because the second dose of the series is dependent on when the adolescent receives their initial dose, the investigators will be following eligible adolescents for 17 months to allow time for those who did not respond to the recall for the initial dose right away to be able to complete the series within the time frame. However, receipt of the completion dose will only be attributed to the recall if it was received within 5 months of the 1st recall for the completion dose. Receipt will be documented by providers within the state immunization registry via EMR direct transfer or manual entry."}]}
{"nct_id":"NCT03505775","start_date":"2017-02-14","phase":"N/A","enrollment":32,"brief_title":"Evaluation of the Muscular and Cutaneous Sodium Storage by 23Na MRI in Patients With Chronic Adrenal Insufficiency","official_title":"Evaluation of the Muscular and Cutaneous Sodium Storage by 23Na Magnetic Resonance Imaging in Patients With Chronic Adrenal Insufficiency Compared to Healthy Subjects","primary_completion_date":"2017-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-10-31","last_update":"2018-04-23","description":"This study investigates the sodium content in the calf muscle and the skin obtained via 23Na-magnetic resonance imaging in patients with chronic adrenal insufficiency compared to healthy controls.","other_id":"23NaMRT-AI","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age > 18 years\r\n\r\n          -  Written informed consent\r\n\r\n          -  Chronic adrenal insufficiency (first diagnosis > 6months), stable hormone replacement\r\n             therapy with glucocorticoids (no dose-adjustment >50mg hydrocortisone within the last\r\n             8 weeks) and mineralocorticoids (only primary adrenal insufficiency)! Or healthy\r\n             control (no adrenal insufficiency, normal serum-electrolytes, normotensive blood\r\n             pressure, no medication with a known influence on the electrolyte balance)!\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnancy or breast-feeding\r\n\r\n          -  Metal-implant (not MRI-compatible)\r\n\r\n          -  Claustrophobia\r\n\r\n          -  Chronic internistic disease (hypertension, heart failure, liver cirrhosis)\r\n\r\n          -  Polydipsia (>4l/d)\r\n\r\n          -  Long-term medication that can cause a hyponatraemia (for example diuretics)\r\n      ","sponsor":"Wuerzburg University Hospital","sponsor_type":"Other","conditions":"Adrenal Insufficiency","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: 23Na magnetic resonance imaging","description":"Imaging/diagnostic: Evaluation of the muscular and cutaneous sodium storage by 23Na magnetic resonance imaging. 23Na magnetic resonance imaging: 23NA-MRI protocol on a 3T scanner (Magnetom PRISMA, Siemens, Erlangen) implementing a 3D sequence."}],"outcomes":[{"outcome_type":"primary","measure":"Muscle sodium content","time_frame":"6 months","description":"Assessment of the sodium content of the calf muscle. Relative sodium signal intensities were calculated as ratio of tissue sodium intensity and the intensity of a vial containing a concentration of 100mmol/l."},{"outcome_type":"primary","measure":"Skin sodium content","time_frame":"6 months","description":"Assessment of the sodium content of the calf skin. Relative sodium signal intensities were calculated as ratio of tissue sodium intensity and the intensity of a vial containing a concentration of 100mmol/l."}]}
{"nct_id":"NCT03048162","start_date":"2017-02-13","phase":"N/A","enrollment":93,"brief_title":"The Effects of Intravenous Fluids on Perfusion Index and Pleth Variability Index","official_title":"The Evaluation of the Effects of Intravenous Fluids on Perfusion Index and Pleth Variability Index","primary_completion_date":"2017-05-15","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-05-15","last_update":"2017-05-16","description":"This study is aimed to assess the effects of intravenously administered three fluid types on perfusion index and pulse variability index in patients during preoperative period. Patients will be randomly divided into three groups. Baseline, 5th, 10th, 15th, 20th, 25th and 30th min non-invasive blood pressure, oxygen saturation, heart rate, room temperature, perfusion index and pulse variability index will be measured and recorded.","other_id":"OMU KAEK 2016/390","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  having a fasting period of 8 hours\r\n\r\n          -  quit smoking for 8 hours before the procedure\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  not to participate in the study\r\n\r\n          -  presence of peripheral vascular disease\r\n\r\n          -  a history of upper extremity surgery\r\n\r\n          -  presence of any kind of psychiatric disease\r\n      ","sponsor":"Tokat Gaziosmanpasa University","sponsor_type":"Other","conditions":"Perfusion","interventions":[{"intervention_type":"Drug","name":"Drug: sodium chloride","description":"500 ml of 0.9% isotonic sodium chloride"},{"intervention_type":"Drug","name":"Drug: Hydroxyethylstarch","description":"500 ml of 6% Hydroxyethylstarch"},{"intervention_type":"Drug","name":"Drug: Ringer-Lactate Infusion Solution Bag","description":"500 ml of Ringer-Lactate Infusion Solution Bag"}],"outcomes":[{"outcome_type":"primary","measure":"Perfusion index","time_frame":"six months","description":"The perfusion of the tissues"},{"outcome_type":"secondary","measure":"Heart rate","time_frame":"six months","description":"Heart rate"},{"outcome_type":"secondary","measure":"Blood pressure","time_frame":"six months","description":"Non-invasive lood pressure"},{"outcome_type":"secondary","measure":"Oxygen saturation","time_frame":"six months","description":"Blood oxygen saturation using pulse oximeter"},{"outcome_type":"secondary","measure":"Pulse variability index","time_frame":"six months","description":"The intravenous fluid requirement of the tissues"}]}
{"nct_id":"NCT03057444","start_date":"2017-02-10","phase":"N/A","enrollment":13,"brief_title":"Resistant Starch, Gut Bacteria and Diabetes","official_title":"Influence of Resistant Starch Type III on Butyrate-producing Gut Bacteria and Diabetes Parameter in (Pre-) Diabetes","primary_completion_date":"2018-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-05-31","last_update":"2018-10-26","description":"The aim of the study is to investigate, if resistant starch type III increases butyrate-producing bacteria in the gut of (pre-) diabetic subjects. Diabetic blood parameters are also of interest.","other_id":"UniHohMet-RSIII-2016","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"open intervention study","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female adult persons ( 18 years)\r\n\r\n          -  Type 2 diabetes mellitus discontinued with lifestyle interventions or insulin therapy\r\n             or oral antidiabetic therapy (sulphonylureas, glinides, SGLT-2 (sodium/glucose\r\n             cotransporter 2) inhibitors, glitazone) or a prediabetic metabolism\r\n\r\n          -  It is foreseeable that no therapy with metformin or -glucosidase inhibitors or DPP-4\r\n             (Dipeptidyl peptidase-4) inhibitors is initiated during the period of study (8 weeks)\r\n\r\n          -  willingness not to systematically change diet and lifestyle habits during the study\r\n\r\n          -  Adequate understanding of the German language and sufficient psychological condition\r\n             to understand the information and instructions associated with the study and to\r\n             complete questionnaires and assessment scales\r\n\r\n          -  Signed informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Treatment of Type II diabetes mellitus by metformin or -glucosidase inhibitors or\r\n             DPP-4 inhibitors\r\n\r\n          -  Diminished diabetic metabolic position or medical necessity to convert the therapy in\r\n             the foreseeable future (HbA1c  7% or fasting glucose  152 mg / dl)\r\n\r\n          -  Participation in another clinical trial (currently or within the last 30 days)\r\n\r\n          -  Incompatibility with the ingredients of the investigational medicinal product\r\n\r\n          -  Pregnancy or lactation\r\n\r\n          -  Inability to take the test preparation orally\r\n\r\n          -  changes in dietary habits and habits within the last 30 days\r\n\r\n          -  Antibiotics intake currently or within the last 30 days\r\n\r\n          -  Drug abuse in the last six months before the start of the study or ongoing. Alcohol\r\n             abuse is defined as an average daily of more than 20 g of alcohol in women and more\r\n             than 30 g of alcohol in men, based on the last six months\r\n\r\n          -  A state of health (including abnormal laboratory values) that, at the discretion of\r\n             the investigator, does not allow study participation, evaluation of study parameters\r\n             or the use of the investigational medicinal product\r\n\r\n          -  Accommodation in a clinic or similar facility, by administrative or judicial order\r\n      ","sponsor":"University of Hohenheim","sponsor_type":"Other","conditions":"Diabetes Mellitus, Type 2|Pre Diabetes","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: SymbioIntest","description":"The intervention is 2x 5g per day the food supplement SymbioIntest (resistant starch types III) over 8 weeks."}],"outcomes":[{"outcome_type":"primary","measure":"Change of gut bacteria","time_frame":"Participants will be followed for the time of eight weeks. Examinations take place at baseline, four and eight week","description":"quantitative Analyse with Next-Generation Sequencing"},{"outcome_type":"primary","measure":"Change of short chain fatty acid concentration in the gut","time_frame":"Participants will be followed for the time of eight weeks. Examinations take place at baseline, four and eight week","description":"gas chromatography"},{"outcome_type":"secondary","measure":"change from baseline in HbA1c at four weeks and eight weeks after consumption resistant starch type III","time_frame":"Participants will be followed for the time of eight weeks. Examinations take place at baseline, four and eight week."},{"outcome_type":"secondary","measure":"change from baseline in insulin at four weeks and eight weeks after consumption resistant starch type III","time_frame":"Participants will be followed for the time of eight weeks. Examinations take place at baseline, four and eight week."},{"outcome_type":"secondary","measure":"change from baseline in blood glucose at four weeks and eight weeks after consumption resistant starch type III","time_frame":"Participants will be followed for the time of eight weeks. Examinations take place at baseline, four and eight week"},{"outcome_type":"secondary","measure":"Change from baseline in anthropometry at four weeks and eight weeks after consumption resistant starch type III","time_frame":"Participants will be followed for the time of eight weeks. Examinations take place at baseline, four and eight week"},{"outcome_type":"other","measure":"Change from baseline in PYY (Peptide YY) at four weeks and eight weeks after consumption resistant starch type III","time_frame":"Participants will be followed for the time of eight weeks. Examinations take place at baseline, four and eight week.","description":"with ELISA"},{"outcome_type":"other","measure":"Change from baseline in GLP-1 (Glucagon-like peptide-1) at four weeks and eight weeks after consumption resistant starch type III","time_frame":"Participants will be followed for the time of eight weeks. Examinations take place at baseline, four and eight week.","description":"with ELISA"}]}
{"nct_id":"NCT03031262","start_date":"2017-02-08","phase":"Phase 1/Phase 2","enrollment":250,"brief_title":"Efficacy and Safety of Chidamide in CBF Leukemia","official_title":"Efficacy and Safety of Chidamide in CBF Leukemia","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-12-31","last_update":"2019-03-22","description":"In this open-label, randomized, prospective clinical trial, CBF acute myeloid leukemia (AML) patients who have reached CR are randomised into two groups and receive high-dose cytarabine (HDAC) or high-dose cytarabine plus chidamide.The safety and efficacy of chidamide is evaluated.","other_id":"IIT2016007-EC-1-3","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":14,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age of 14 to 55 years old;\r\n\r\n          2. Patients that meet the diagnostic criteria(WHO 2008 criteria) of AML (except APL\r\n             subtypes) and with AML1-ETO or CBF-MYH11 mutation.\r\n\r\n          3. Reached CR after induction regimen.\r\n\r\n          4. ECOG score of  2;\r\n\r\n          5. Patients with eligible laboratory examination including liver,renal and heart\r\n             function.\r\n\r\n          6. Adult patients are willing to participate in the study and sign the informed consent\r\n             by themselves or by their immediate family. Patients under 18 years old willing to\r\n             participate should have their legal guardians sign the informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Secondary leukemia.\r\n\r\n          2. Patients had other tumor at active stage or had received radiotherapy or chemotherapy\r\n             in the last 6 months due to other tumor.\r\n\r\n          3. Patients with other blood diseases(for example, haemophiliacs) are excluded.However,\r\n             patients with abnormal blood count, but with undiagnosed MDS or MPD patients are\r\n             included.\r\n\r\n          4. Acute panmyelosis with myelofibrosis and myeloid sarcoma patients;\r\n\r\n          5. With BCR-ABL fusion gene;\r\n\r\n          6. Pregnant or lactating women;\r\n\r\n          7. With ineligible renal or liver function;\r\n\r\n          8. With active cardiovascular disease;\r\n\r\n          9. Severe infection disease including uncured tuberculosis pulmonary aspergillosis;\r\n\r\n         10. AIDS;\r\n\r\n         11. Patients had central nervous system involvement when they were diagnosed as AML.\r\n\r\n         12. Patients with epilepsy or dementia or other mental disease who couldn't understand or\r\n             follow the research.\r\n\r\n         13. Drugs, medical, mental or social situation may distract patients from following the\r\n             research or being evaluated the results.\r\n\r\n         14. Patients with other factors which were considered unsuitable to participate in the\r\n             study by the investigators.\r\n      ","sponsor":"Institute of Hematology & Blood Diseases Hospital","sponsor_type":"Other","conditions":"AML","interventions":[{"intervention_type":"Drug","name":"Drug: Cytarabine","description":"Cytarabine at a dose of 3g//d on the first, third and fifth day."},{"intervention_type":"Drug","name":"Drug: Chidamide","description":"Chidamide at a dose of 20mg/d twice a week for 3 months."}],"outcomes":[{"outcome_type":"primary","measure":"Relapse-Free Survival Rate (RFS)","time_frame":"Within 5 years after randomization","description":"RFS is defined as the time from the date of complete remission (CR) after entry in this trial until the date of documented relapse or death for CBF positive leukemia patients who achieve CR."},{"outcome_type":"secondary","measure":"Non-relapse Mortality","time_frame":"through treatment completion, an average of 5 months"},{"outcome_type":"secondary","measure":"Overall Survival Rate (OS)","time_frame":"Within 5 years after randomization"},{"outcome_type":"secondary","measure":"Cumulative incidence of relapse","time_frame":"Within 5 years after randomization"}]}
{"nct_id":"NCT03066219","start_date":"2017-02-07","phase":"Phase 2","enrollment":157,"brief_title":"Safety and Efficacy of BRM421 for Dry Eye Syndrome","official_title":"A Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of BRM421 Ophthalmic Solution in Subjects With Dry Eye Using a Controlled Adverse Environment (CAE) Model","primary_completion_date":"2017-05-20","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-06-28","last_update":"2017-11-22","description":"The objective of this study is to compare the safety and efficacy of BRM421 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye.","other_id":"BRM421-16-C001-PR","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Be at least 18 years of age;\r\n\r\n          -  Provide written informed consent;\r\n\r\n          -  Have a reported history of dry eye for at least 6 months prior to enrollment;\r\n\r\n          -  Have a history of use of eye drops\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Have any clinically significant slit lamp findings at Visit 1 that may include active\r\n             blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active\r\n             ocular allergies that require therapeutic treatment, and/or in the opinion of the\r\n             investigator may interfere with study parameters;\r\n\r\n          -  Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active\r\n             ocular inflammation at Visit 1;\r\n\r\n          -  Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses\r\n             during the study;\r\n\r\n          -  Have used any eye drops within 2 hours of Visit 1;\r\n\r\n          -  Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the\r\n             last 12 months;\r\n\r\n          -  Be a woman of childbearing potential who is not using an acceptable means of birth\r\n             control; acceptable methods of contraception\r\n      ","sponsor":"BRIM Biotechnology Inc.","sponsor_type":"Industry","conditions":"Dry Eye Syndrome","interventions":[{"intervention_type":"Drug","name":"Drug: BRM421","description":"A topical solution of BRIM421 ophthalmic drops"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"vehicle ophthalmic drops"}],"outcomes":[{"outcome_type":"primary","measure":"Sign: Corneal fluorescein staining score","time_frame":"Up to 4 weeks"},{"outcome_type":"primary","measure":"Symptom: Ocular discomfort score","time_frame":"Up to 4 weeks"},{"outcome_type":"secondary","measure":"Tear film break-up time","time_frame":"Up to 4 weeks"},{"outcome_type":"secondary","measure":"Conjunctival Redness","time_frame":"Up to 4 weeks"},{"outcome_type":"secondary","measure":"Ocular Surface Disease Index (OSDI)©","time_frame":"Up to 4 weeks"}]}
{"nct_id":"NCT03064893","start_date":"2017-02-06","phase":"N/A","enrollment":60,"brief_title":"The Use of Alloderm Versus Dermacell in Immediate Implant Based Breast Reconstruction","official_title":"A Randomised Controlled Trial Comparing the Use of Alloderm Versus Dermacell in Immediate Implant Based Breast Reconstruction","primary_completion_date":"2018-10-11","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-02-19","last_update":"2020-03-24","description":"Breast reconstruction after mastectomy has been shown to provide psychosocial benefits to breast cancer patients and is considered an integral part of breast cancer treatment. In general, breast reconstruction can be accomplished using the patients own tissues or implantable prosthetic devices. Various acellular dermal matrices (ADMs) are offered on the market and the costs vary widely despite very similar qualities. The two most commonly used ADM products in North America by far are Dermacell and Alloderm. The difference between the two products include a) level of sterility, with Dermacell being sterilized to 10-9 while Alloderm is sterilized to 10-6 and b) the consistency and thickness of the biologic material and c) a significant different in cost ($2200 CAD vs $3600, respectively). Each product has shown to be safe and effective. As such, clinical equipoise exists. This will be a pragmatic trial to evaluate Dermacell with Alloderm in a head to head randomized fashion, with regards to the postoperative complications, namely infection, seroma formation (as measured by drain duration and output), loss of implant, incidence of revisional surgery and capsular contracture.","other_id":"OTT 16-06","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":20,"maximum_age":90,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Female patient\r\n\r\n          -  Ages 20-90\r\n\r\n          -  All patients undergoing mastectomy for breast cancer or prophylaxis for breast cancer\r\n             with immediate implant-based reconstruction\r\n\r\n          -  Able to provide verbal consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who have had prior chest wall or irradiation on the reconstructed side\r\n\r\n          -  Patients not undergoing immediate breast reconstruction at the time of mastectomy\r\n\r\n          -  Any patient with a contraindication to immediate breast reconstruction\r\n      ","sponsor":"Ottawa Hospital Research Institute","sponsor_type":"Other","conditions":"Breast Reconstruction","interventions":[{"intervention_type":"Device","name":"Device: Alloderm","description":"Reconstruction material"},{"intervention_type":"Device","name":"Device: Dermacell","description":"Reconstruction material"}],"outcomes":[{"outcome_type":"primary","measure":"Postoperative duration of drain placements","time_frame":"within 6 months of initial surgery"},{"outcome_type":"secondary","measure":"Episodes of seroma formation requiring aspiration","time_frame":"within 6 months of initial surgery"},{"outcome_type":"secondary","measure":"Loss of implant","time_frame":"within 6 months of initial surgery"},{"outcome_type":"secondary","measure":"Revisional surgery/ return to operating room","time_frame":"within 6 months of initial surgery"},{"outcome_type":"secondary","measure":"Wound dehiscence or debridement","time_frame":"within 6 months of initial surgery"},{"outcome_type":"secondary","measure":"Capsular contracture (as identified by the plastic surgeon)","time_frame":"within 6 months of initial surgery"},{"outcome_type":"secondary","measure":"Number of additional postoperative clinic visits with the plastic surgeon (beyond the routine)","time_frame":"within 6 months of initial surgery"},{"outcome_type":"secondary","measure":"Economics of total costs","time_frame":"2 years","description":"Economic impact will be assessed based on calculation of total costs with each material used to include the material costs, duration of operative room use, clinic and inpatient hospital costs, surgical billing costs and anaesthesia costs"}]}
{"nct_id":"NCT03049267","start_date":"2017-02-02","phase":"Phase 2","enrollment":20,"brief_title":"Short-term Safety, Efficacy and Mode of Action of Apremilast in Moderate Suppurative Hidradenitis","official_title":"Short-term Safety, Efficacy and Mode of Action of Apremilast in Moderate Suppurative Hidradenitis: A Randomised Double-blind Placebo Controlled Trial","primary_completion_date":"2017-12-06","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-06-28","last_update":"2018-07-24","description":"Study design: A double-blind randomised placebo-controlled trial Intervention: Randomized placebo controlled treatment of 20 HS patients of which fifteen patients will be randomized to apremilast and five patients to placebo. The total duration of the treatment period per subject is 16 weeks. Primary objectives: To evaluate the expression profile of inflammatory cytokines in HS lesional skin at week four (t=4) and week sixteen (t=16): - of patients receiving apremilast compared to placebo; - within both groups relative to baseline (t=0). Secondary objectives: - To prospectively evaluate the clinical efficacy of apremilast. - To assess the effect of apremilast on patient reported outcomes measures. - To assess the short-term safety and tolerability of apremilast in patients with hidradenitis suppurativa.","other_id":"SMASH trial","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Key inclusion criteria:\r\n\r\n          -  Adult ( 18 years of age) male or female patients with moderate HS according to a PGA\r\n             of 3 on the 5-point HS-Physician Global Assessment (HS-PGA);\r\n\r\n          -  HS of more than 6 months duration; have lesions in at least two anatomical locations.\r\n\r\n        Key exclusion criteria:\r\n\r\n          -  Contra-indication for apremilast; previous use of apremilast; have any current and/or\r\n             recurrent clinically significant skin condition in the treatment area other than HS;\r\n\r\n          -  Presence of other uncontrolled major disease;\r\n\r\n          -  Pregnant or lactating women.\r\n      ","sponsor":"M.B.A. van Doorn","sponsor_type":"Other","conditions":"Hidradenitis Suppurativa","interventions":[{"intervention_type":"Drug","name":"Drug: Apremilast","description":"Fifteen patients will be supplied of apremilast for daily oral use; 16 weeks."},{"intervention_type":"Drug","name":"Drug: Placebo Oral Tablet","description":"Five patients will be supplied with placebo tablets with identical labeling as apremilast for daily use; 16 weeks."}],"outcomes":[{"outcome_type":"primary","measure":"Change of expression levels of inflammatory cytokine mRNA in HS lesional skin.","time_frame":"t=16 weeks","description":"measurement by qPCR"},{"outcome_type":"primary","measure":"Change of expression levels of inflammatory cytokine protein in HS lesional skin.","time_frame":"t=16 weeks","description":"measurement by ELISA"},{"outcome_type":"secondary","measure":"Abscesses count","time_frame":"t=0 weeks, t=4 weeks, t=16 weeks","description":"Total number of abscesses [A]"},{"outcome_type":"secondary","measure":"Nodule count","time_frame":"t=0 weeks, t=4 weeks, t=16 weeks","description":"Total number of inflammatory [N] and non-inflammatory nodules"},{"outcome_type":"secondary","measure":"Fistula count","time_frame":"t=0 weeks, t=4 weeks, t=16 weeks","description":"Total count of draining fistulas"},{"outcome_type":"secondary","measure":"Hidradenitis Suppurativa Physician's Global Assessment (HS-PGA) score","time_frame":"t=0 weeks, t=4 weeks, t=16 weeks","description":"Based on the HS lesion count"},{"outcome_type":"secondary","measure":"Hidradenitis Suppurativa Clinical Response (HiSCR)","time_frame":"t=0 weeks, t=16 weeks","description":"Based on the AN count; The proposed definition of 50% and 30% responders to treatment (HiSCR achievers) is respectively: (i) at least a 50% and 30% reduction in ANs, (ii) no increase in the number of abscesses, and (iii) no increase in the number of draining fistulas from baseline."},{"outcome_type":"secondary","measure":"Numerical Rating Scale (NRS)","time_frame":"t=0 weeks, t=4 weeks, t=16 weeks","description":"To assess the patient reported outcome measures (PROMs) pain, pruritus and patient disease global assessment score;"},{"outcome_type":"secondary","measure":"Dermatology Life Quality Index (DLQI)","time_frame":"t=0 weeks, t=4 weeks, t=16 weeks","description":"To assess the patient reported outcome measures (PROM) quality of life"},{"outcome_type":"secondary","measure":"Incidence of Treatment-Emergent Adverse Events","time_frame":"Multiple time points between t=0 weeks and t=16 weeks","description":"Vital signs: heart rate, temperature, blood pressure. Patient reported adverse events Safety laboratories: White blood cell count, Absolute neutrophil count, Hemoglobin, Platelets, Serum Creatinine, ALT, Alkaline phosphatase"}]}
{"nct_id":"NCT03132870","start_date":"2017-02-01","enrollment":66,"brief_title":"Predictive Diagnostic Criteria for Diagnosis of Transbronchial Biopsies, Echo-guided by Mini-probe in Peripheral Lung Lesions","official_title":"Predictive Diagnostic Criteria for Diagnosis of Transbronchial Biopsies, Echo-guided by Mini-probe in Peripheral Lung Lesions","primary_completion_date":"2017-06-01","study_type":"Observational","rec_status":"Completed","completion_date":"2017-06-01","last_update":"2018-10-15","description":"The diagnosis of nodules and peripheral lung masses (lesions not accessible in classical bronchial endoscopy) is a challenge for the pulmonologist especially when these lesions are not accessible to the transparietal aspirate under scanner. The overall sensitivity of flexible fibroscopy for peripheral lesions is 69% (bronchial brushing, transbronchial biopsies, bronchoalveolar lavage and blind trans-mucosal aspiration). This sensitivity varies from 33% when the lesion is less than 2 cm, to 62% when it is greater than 2 cm. The puncture under scan of these lesions remains the gold standard. In the meta-analysis of Schreiber G et al., The diagnostic sensitivity of transparietal aspirate for peripheral lung lesions is 90%. On the other hand, the complication rate of this technique is not negligible, with in the study of Boskovic et al, a pneumothorax rate varying from 8 to 64%. In the literature, the only risk factor actually found is the existence of emphysema. However, thoracic drainage is rarely necessary. Bronchial echo-endoscopy using a radial mini-probe was developed in 1992 by Thomas Hrter and Peter Hanrath to produce ultrasound guided specimens of these peripheral lung lesions. In the meta-analysis of Steinfort et al., The overall sensitivity of this mini-probe technique is 73% for the histological diagnosis. From the same author, a randomized trial compared the diagnostic sensitivity of transparietal aspirate undergoing ultrasound-guided transbronchial biopsy with a radial mini-probe: this was 93.3% versus 87.5% with no significant difference (p = 1 ), Whereas post-procedure complications are less frequent in the ultrasound procedure (27% versus 3%, p = 0.03). Steinfort also showed that the economic cost of bronchial echo-endoscopy by radial mini-probe and transthoracic puncture under CT was similar both to the success or failure of the first procedure requiring further investigations . Mini-probe-guided specimens are therefore an efficient diagnostic alternative to obtain a histological diagnosis of these peripheral lung lesions","other_id":"RNI2016-40 Dr Basille","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients undergoing a mini-probe fibroscopy","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  All patients who underwent mini-probe fibroscopy at Amiens University Hospital from\r\n             January 2013 to March 2016\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  No\r\n      ","sponsor":"Centre Hospitalier Universitaire, Amiens","sponsor_type":"Other","conditions":"Transbronchial Biopsies|Peripheral Lung Lesion","interventions":[{"intervention_type":"Other","name":"Other: Define predictive criteria for the diagnostic performance of echo-guide samples by mini-probe in peripheral lung lesions","description":"Define predictive criteria for the diagnostic performance of echo-guide samples by mini-probe in peripheral lung lesions"}],"outcomes":[{"outcome_type":"primary","measure":"Analyze predictive criteria of the performance diagnosis by echo-guide sampling by mini-probe","time_frame":"39 months"}]}
{"nct_id":"NCT04416620","start_date":"2017-02-01","phase":"N/A","enrollment":118,"brief_title":"The Impact of a Pharmaceutical Care Model on Improving Polycystic Ovary Syndrome","official_title":"The Impact of a Pharmaceutical Care Model on Improving Polycystic Ovary Syndrome Associated Factors Amongst Females in Jordan and Syria","primary_completion_date":"2017-03-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-07-30","last_update":"2020-06-04","description":"The primary aim of this study was to estimate the prevalence of anxiety disorder and depression amongst Syrian and Jordanian women who are suffering from PCOS in Damascus and Amman. The secondary aim was to assess the effectiveness of a PCOS pharmaceutical care service on selected patient's biochemical parameters, QOL, anxiety, and depression scale. The third aim is to identify the factors associated with QOL, anxiety and depression scores' change across the study. Null Hypothesis (research hypothesis): The intervention of PCOS pharmaceutical care service will lead to no significant differences in patient's depression, anxiety, QOL, and some biochemical parameters in comparison to females who will not receive this intervention in both Syria and Jordan. Alternative Hypothesis (research hypothesis): The intervention of PCOS pharmaceutical care service will have a significant impact on patient's depression, anxiety, QOL, and some biochemical parameters in comparison to patients who will not receive this intervention in both Syria and Jordan.","other_id":"2017-PHA 2","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"Single","intervention_model_description":"Participants in the active group received the usual care delivered at the community pharmacies at both countries plus the pharmaceutical care service designed by the research group and provided by the clinical pharmacist, an experienced female with extensive knowledge on PCOS. The intervention was delivered via oral advice and recommendations, and written material, with a special focus on diet and exercise. Participants in the control group received the usual care only and did not receive the pharmaceutical care service.\r\nFollowing the intervention, both groups were followed up for four months and re-interviewed at the community pharmacy.","sampling_method":"","gender":"Female","minimum_age":16,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Females who had a doctor-diagnosis of PCOS.\r\n\r\n          -  Above the age of 16.\r\n\r\n          -  Able to complete the 4-month study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Females with an old diagnosis of PCOS with no doctor visit in the past month.\r\n\r\n          -  Can not speak and understand Arabic.\r\n      ","sponsor":"Applied Science Private University","sponsor_type":"Other","conditions":"Polycystic Ovary Syndrome","interventions":[{"intervention_type":"Other","name":"Other: The PCOS pharmaceutical care service","description":"The intervention was provided in the format of oral plus written information. The information provided included the importance of exercise and motivational messages to exercise more at home or in the gym.\r\nThe 2nd part was about the importance of decreasing the stress levels. Participants were informed to perform a simple breathing exercise on daily basis twice a day.\r\nThe 3rd part aimed at improving participants' diets. They were informed to follow specific diet recommendations and to avoid certain types of food, explaining to them how it may negatively affect their PCOS condition.\r\nThe 4th part was about the PCOS treatment that was discussed with the participants. Females were advised on the importance of using their correct treatment. They were informed of the importance of adhering to their prescribed medications, accepting that it was a long-term treatment plan, and to consult with their specialist if their treatment was not effective, or in the case of medication side effects."}],"outcomes":[{"outcome_type":"primary","measure":"Anxiety prevalence","time_frame":"At baseline","description":"Anxiety prevalence assessment using the Beck Anxiety Inventory. The BAI scale, consisted of 21-multiple-choice questions, with 4-point scale indicating the degree of anxiety severity (0-3; all questions were scored positively). Points were summed to produce a total measure score, indicating four levels of anxiety severity: 0-7 reflecting minimal level of anxiety, 8-15 reflecting mild level of anxiety, 16-25 reflecting moderate level of anxiety and 26-63 reflecting severe level of anxiety. The possible score for each participant ranged from 0 to 63. Lower scores indicated better anxiety symptoms."},{"outcome_type":"primary","measure":"Depression prevalence","time_frame":"At baseline","description":"Depression prevalence assessment using the Beck Depression Inventory. The BDI is a 4-point scale (0-3) indicating the level of depression severity, with the score referring to six levels: 0-10 indicating the ups and downs reported by the participant were normal, 11-16 reflecting mild mood disturbances, 17-20 reflecting borderline clinical depression, 21-30 reflecting moderate depression, 31-40 reflecting severe depression, and over 40 reflecting extreme depression. The possible score for each participant ranged from 0 to 63. The BDI Questionnaire evaluates pessimistic attitude, loss of appetite, sad mood and feelings of guilt. Lower scores indicated better depression symptoms."},{"outcome_type":"primary","measure":"Anxiety scale","time_frame":"Change from Baseline and follow-up (up to 17 weeks)","description":"Levels of Anxiety severity and mean score assessment were done by the Beck Anxiety Inventory.\r\nThe BAI scale, consisted of 21-multiple-choice questions, with 4-point scale indicating the degree of anxiety severity (0-3; all questions were scored positively). Points were summed to produce a total measure score, indicating four levels of anxiety severity: 0-7 reflecting minimal level of anxiety, 8-15 reflecting mild level of anxiety, 16-25 reflecting moderate level of anxiety and 26-63 reflecting severe level of anxiety. The possible score for each participant ranged from 0 to 63. Lower scores indicated better anxiety symptoms."},{"outcome_type":"primary","measure":"Depression scale","time_frame":"Change from Baseline and follow-up (up to 17 weeks)","description":"Levels of Depression severity and mean score assessment were done by the Beck Depression Inventory.\r\nThe BDI is a 4-point scale (0-3) indicating the level of depression severity, with the score referring to six levels: 0-10 indicating the ups and downs reported by the participant were normal, 11-16 reflecting mild mood disturbances, 17-20 reflecting borderline clinical depression, 21-30 reflecting moderate depression, 31-40 reflecting severe depression, and over 40 reflecting extreme depression. The possible score for each participant ranged from 0 to 63. The BDI Questionnaire evaluates pessimistic attitude, loss of appetite, sad mood and feelings of guilt. Lower scores indicated better depression symptoms."},{"outcome_type":"primary","measure":"Quality of Life scale assessment","time_frame":"Change from Baseline Quality of Life and follow-up (up to 17 weeks)","description":"Quality of Life assessment using the polycystic ovary syndrome health-related QOL questionnaire (PCOSQ).\r\nIt has a 30 questions about symptoms related to menstruation and mood. It can identify seven factors affecting the QOL in PCOS women including: emotional disturbance, hirsutism, weight concerns, infertility, menstrual symptoms, menstrual predictability and acne. The QOL was analyzed individually as a continuous scale out of seven to assess the QOL in patients (the higher the score is, the better the QOL is). After that, each question of the 30 questions included in the PCOSQ questionnaire was analyzed, and the mean score within each question was obtained and compared between baseline and follow-up. After that, each domain included in the QOL questionnaire was analyzed individually. Mean score of each domain was obtained and compared between baseline and follow-u to assess the impact of lifestyle modifications on that domain."},{"outcome_type":"primary","measure":"Blood pressure assessment","time_frame":"Change from Baseline Blood Pressure and follow-up (up to 17 weeks)","description":"Systolic and diastolic blood pressure measurements were measured using the right arm, twice after a 10-min rest and averaged by using the gold standard, mercury sphygmomanometers"},{"outcome_type":"primary","measure":"Blood Glucose levels","time_frame":"Change from Baseline Blood Glucose levels and Follow-up (up to 17 weeks)","description":"Blood Glucose levels assessment using the Multi-parametric device."},{"outcome_type":"primary","measure":"Blood Cholesterol levels","time_frame":"Change from Baseline Blood Cholesterol levels and follow-up (up to 17 weeks)","description":"Blood Cholesterol levels assessment using the Multi-parametric device."},{"outcome_type":"primary","measure":"Blood Triglycerides levels","time_frame":"Change from Baseline Blood Triglycerides levels and Follow-up (up to 17 weeks)","description":"Blood Triglycerides levels assessment using the Multi-parametric device."},{"outcome_type":"primary","measure":"Body Mass Index","time_frame":"Change from Baseline Body mass index and Follow-up (up to 16 weeks)","description":"the Body Mass Index was calculated for each participant depending on their weight and hight."},{"outcome_type":"secondary","measure":"Smoking frequency","time_frame":"Change from Baseline Smoking frequency and Follow-up (up to 17 weeks)","description":"smokers participants recorded the number of cigarettes smoked per day."},{"outcome_type":"secondary","measure":"Hooka frequency","time_frame":"change from Baseline Hooka frequency and Follow-up (up to 17 weeks)","description":"the frequency hooka habits was recorded."}]}
{"nct_id":"NCT03037125","start_date":"2017-02-01","phase":"N/A","enrollment":14,"brief_title":"The Evaluation Of Bone Width Gain Following Split Crest Technique With Or Without Platelet Rich Fibrin( PRF)","official_title":"The Evaluation Of Bone Width Gain Following Split Crest Technique With Or Without PRF In Conjunction With Simultaneous Implant Placement In Narrow Alveolar Ridges: A Randomized Controlled Clinical Trial","primary_completion_date":"2017-08-15","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2018-01-01","last_update":"2017-02-01","description":"Split crest technique is a technique for horizontal bone augmentation used in case of narrow alveolar ridges as an alternative to the more aggressive techniques such as onlay bone grafting, guided bone regeneration (GBR) and distraction osteogenesis The study goal is to evaluate whether if there will be any benefit of using platelet rich fibrin (PRF) with the split crest technique regarding bone width gain and healing response in comparison with split crest technique alone, where PRF is considered an autologous, growth factor containing material which is easy to collect and is of low cost.","other_id":"PERIO 3:7:3","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patients with at least one missing tooth in the maxillary region\r\n\r\n          2. All the selected patients have a bucco-palatal width of the edentulous alveolar ridge\r\n             from 3.5-5.5mm.\r\n\r\n          3. All the selected patients have at least 12 mm residual bone height at the edentulous\r\n             area\r\n\r\n          4. The recipient site of the implant should be free from any pathological conditions.\r\n\r\n          5. No diagnosed bone disease or medication known to affect bone metabolism.\r\n\r\n          6. Patients who are cooperative, motivated, and hygiene conscious.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients unable to undergo minor oral surgical procedures.\r\n\r\n          2. Patients with a history of drug abuse or catabolic drugs.\r\n\r\n          3. Patients with a history of psychiatric disorder.\r\n\r\n          4. Patients with unrealistic expectations about the esthetic outcome of implant therapy.\r\n\r\n          5. Patients with insufficient vertical inter-arch space, upon centric occlusion, to\r\n             accommodate the available restorative components.\r\n\r\n          6. Patients in the growth stage with partially erupted teeth.\r\n\r\n          7. Patients who have any systemic condition that may contraindicate implant therapy.\r\n\r\n          8. Patients who have any habits that might jeopardize the osseointegration process, such\r\n             as smoking and alcoholism.\r\n\r\n          9. Patients with parafunctional habits that produce overload on the implant, such as\r\n             bruxism and clenching.\r\n      ","sponsor":"Cairo University","sponsor_type":"Other","conditions":"Ridge Deficiency","interventions":[{"intervention_type":"Procedure","name":"Procedure: Split Crest with PRF","description":"Narrow ridges are split to increase the ridge width and immediate implants are placed with PRF closing the gap"},{"intervention_type":"Procedure","name":"Procedure: Split Crest without PRF","description":"Narrow ridges are split to increase the ridge width and immediate implants are placed without grafting"}],"outcomes":[{"outcome_type":"primary","measure":"Bone width gain","time_frame":"6 months"}]}
{"nct_id":"NCT03032835","start_date":"2017-01-31","enrollment":300,"brief_title":"Partners Calciphylaxis Biobank","official_title":"Partners Calciphylaxis Biobank and Patient Registry","primary_completion_date":"2030-12-31","study_type":"Observational [Patient Registry]","rec_status":"Recruiting","completion_date":"2030-12-31","last_update":"2021-02-24","description":"Calciphylaxis, a vascular calcification disorder, is a rare and serious disorder characterized by calcification of dermal arterioles. There are significant gaps in the understanding of the pathophysiology and risk factors for calciphylaxis. At present, there is no effective treatment. Uncertain pathobiology, rare incidence and lack of collaborative approach have been some of the major limiting factors towards treating calciphylaxis. The Partners Calciphylaxis Biorepository (PCB) aims to address these gaps within calciphylaxis research by utilizing existing and, when necessary, developing new infrastructure to support the consent of patients and the collection of dedicated samples for a calciphylaxis repository.","other_id":"2016P002690","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients with skin lesions consistent with calciphylaxis","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Male or female 18 years old\r\n\r\n          2. Skin lesions consistent with calciphylaxis diagnosis as determined by the treating\r\n             clinician\r\n\r\n          3. Informed of the investigational nature of the study and sign written Informed consent\r\n             OR are eligible for surrogate consent process based on impaired decision making\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients <18 years of age\r\n\r\n          2. Prisoners\r\n      ","sponsor":"Massachusetts General Hospital","sponsor_type":"Other","conditions":"Calciphylaxis|Calcific Uremic Arteriolopathy|End Stage Renal Disease|Chronic Kidney Diseases","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Number of patients with improvement in calciphylaxis skin lesions","time_frame":"6 months","description":"Skin lesions will be assessed by investigators at baseline (entry into study) and at 6 months to determine whether there is improvement. The investigators will determine clinical, laboratory and genetic predictors of this outcome in calciphylaxis patients."},{"outcome_type":"secondary","measure":"Number of patients with >30% improvement in pain severity","time_frame":"4weeks","description":"Pain severity will be assessed by investigators at baseline (entry into study) and at 4 weeks to determine whether there is improvement. Pain is measured using Wong-Baker Faces pain rating scale. The investigators will examine clinical, laboratory and genetic predictors of this outcome in calciphylaxis patients."},{"outcome_type":"secondary","measure":"Time to death in patients with calciphylaxis","time_frame":"Up to 5 years","description":"Time to death is defined as time from the diagnosis of calciphylaxis to death (or to the end of follow up). The investigators will examine clinical, laboratory and genetic predictors of this outcome in calciphylaxis patients."}]}
{"nct_id":"NCT02730793","start_date":"2017-01-31","phase":"Phase 2","enrollment":5,"brief_title":"Aztreonam Aerosol to Treat Cystic Fibrosis Nasal Disease","official_title":"Aztreonam Aerosol to Treat Cystic Fibrosis Nasal Disease","primary_completion_date":"2019-09-19","study_type":"Interventional","rec_status":"Terminated","completion_date":"2019-09-19","last_update":"2021-01-28","description":"This study is designed as a masked, two center, randomized, placebo-controlled pilot study to evaluate the safety and efficacy of nasal and oral inhalation of 75 mg aztreonam in subjects with CF and lung infection due to PA. The study will involve two sites: Virginia Commonwealth University Medical Center (VCU) and Eastern Virginia Medical School (EVMS). Potential subjects will be identified in each site's CF clinic.","other_id":"HM20005657","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":7,"maximum_age":100,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Males or females 7 years of age or older and able to perform pulmonary function\r\n             testing\r\n\r\n          2. Confirmed diagnosis of CF by the 1997 CF Consensus Conference criteria and followed by\r\n             the VCU or EVMS CF clinic\r\n\r\n          3. Presence of PA in 2 lower respiratory tract (sputum) cultures in the 24 months before\r\n             screening\r\n\r\n          4. Subjects and/or parent guardian must be able to give written informed consent prior to\r\n             any study related procedure\r\n\r\n          5. All sexually active female subjects who are of childbearing potential must agree to\r\n             use an effective method of contraception (i.e.condoms or abstinence).\r\n\r\n          6. All sexually active female subjects must have a negative pregnancy test at screening\r\n             (V0).\r\n\r\n          7. Clinically stable determined by the study physician with no significant new\r\n             respiratory symptoms.\r\n\r\n          8. Presence of PA in nasal culture (swab or secretion) or sinus culture obtained in the\r\n             12 months before screening or at screening visit\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Use of oral, IV or inhaled antibiotics within 0 days before study other than low dose\r\n             azithromycin\r\n\r\n          2. Severe pulmonary disease with FEV1<30% predicted of baseline SpO2<0.90\r\n\r\n          3. ENT surgery within 6 months of screening\r\n\r\n          4. Allergy or documented adverse reaction to aztreonam\r\n\r\n          5. Epistaxis or significant (>30mL) hemoptysis in the past 6 months\r\n\r\n          6. Frequent (weekly or more frequently) or severe headaches\r\n\r\n          7. Subject is unlikely to comply with the procedures scheduled in the protocol\r\n\r\n          8. Subject participates in another clinical trial within 30 days prior to study entry\r\n\r\n          9. Subjects who have had a lung transplant will be excluded\r\n\r\n         10. Prisoners will be excluded\r\n\r\n         11. Non-English Speaking patients will be excluded\r\n      ","sponsor":"Virginia Commonwealth University","sponsor_type":"Other","conditions":"Cystic Fibrosis","interventions":[{"intervention_type":"Drug","name":"Drug: Oral Aztreonam","description":"Standard Therapy Comparator (Oral Cayston 75mg three times a day)"},{"intervention_type":"Drug","name":"Drug: Nasal Aztreonam","description":"Study Therapy (nasal Aztreonam 75mg twice per day)"},{"intervention_type":"Drug","name":"Drug: Nasal Placebo","description":"Placebo (nasal saline twice per day)"}],"outcomes":[{"outcome_type":"secondary","measure":"Change in Pulmonary Function (FVC and FEV1 Percent Predicted) on Day 140","time_frame":"Day 140","description":"Routine spirometry will be performed according to American Thoracic Society (ATS) guidelines. A minimum of three maneuvers will be performed. The largest FVC and FEV1 will be reported after examining data from all acceptable curves even if they did not originate from the same maneuver. Data will be expressed both in absolute values and as percent (%) predicted based upon NHANES predicted values."},{"outcome_type":"secondary","measure":"Change in Acoustic Rhinometry for Nasal Obstruction (Volume) (Will be Measured at VCU Site ).","time_frame":"1 year","description":"Acoustic rhinometry is used to measure cross-sectional volume of the nasal cavity allowing the calculation of nasal volume. Reflected sound waves are painlessly introduced through nasal adaptors into the nasal passages allowing the production of area-distance graphs."},{"outcome_type":"primary","measure":"Number of Protocol-defined Pulmonary Exacerbations Treated With IV Anti-pseudomonal Antibiotics on Day 140","time_frame":"140 days","description":"Protocol-Defined Pulmonary Exacerbation includes events that are characterized by change or worsening pulmonary symptoms (increased cough, increased sputum production and chest congestion, decreased appetite and exercise tolerance), loss of weight, and lung function decline that prompt initation of antibiotic therapy. Protocol-defined exacerbations in subjects that warrant treatment with IV antibiotics will be determined from the medical record during the course of this study."},{"outcome_type":"secondary","measure":"Time to First Protocol-defined Pulmonary Exacerbation Treated With IV Anti-pseudomonal Antibiotics","time_frame":"Up to 6 months","description":"Protocol-Defined Pulmonary Exacerbation includes events that are characterized by change or worsening pulmonary symptoms (increased cough, increased sputum production and chest congestion, decreased appetite and exercise tolerance), loss of weight, and lung function decline that prompt initation of antibiotic therapy. Protocol-defined exacerbations in subjects that warrant treatment with IV antibiotics will be determined from the medical record during the course of this study. The time of beginning the study to first protocol-defined pulmonary exacerbation will also be determined from the medical record during the course of this study."},{"outcome_type":"secondary","measure":"Change in Sinus and Nasal QoL Questionnaire (SNOT-20) on Day 140 and Day 168","time_frame":"Day 140 and Day 168","description":"The Sino-Nasal Outcome Test 20 (SNOT-20) is a validated health-related QOL questionnarie designed to determine the impact of sinonasal dysfunction. Patients will assess nasal symptoms, emotion, and activity on a scale of worsening symptoms scored 1 through 7 to provide a quantifiable score capable of disease severity. It has been shown as a responsive measure of health-related quality of life and suitable for use in outcomes studies and routine clinical care. Survey responses from Day 140 and Day 168 will be compared to the SNOT20 survey responses from previous visits (V1, V2, and V4)"},{"outcome_type":"secondary","measure":"Change in Cystic Fibrosis QoL Score (CFQ-R) on Day 140","time_frame":"Day 140","description":"The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Visits 1, 6, and 7. The endpoint was change in CFQR on day 140 compared to V1 and V5."},{"outcome_type":"secondary","measure":"Change in Paired Sputum Cultures and Nasal Swabs for Bacteria and Antibiotic Resistance","time_frame":"1 year","description":"Expectorated sputum and nasal swabs will be cultured at each visit using standardized procedures to identify CF pathogens as well as susceptibility to a standard panel of antibiotics."},{"outcome_type":"secondary","measure":"Number of Safety and Adverse Events Including Nasal Stuffiness, Epistaxis, and Headache.","time_frame":"1 year","description":"The frequency, severity and duration of all nasal and pulmonary adverse events, regardless of cause, will be recorded in REDCap as an electronic case report form. Serious adverse events will be captured in OnCore. The frequency and severity of adverse events will be calculated for each patient, with each patient counted once using the most severe grade experienced. The duration of adverse events will be calculated by the number of days each event persisted. Tables will be generated for all adverse events including serious adverse events and withdraws from the study."},{"outcome_type":"secondary","measure":"Number of Protocol-defined Pulmonary Exacerbations Treated With Oral Anti-pseudomonal Antibiotics","time_frame":"1 year","description":"Protocol-Defined Pulmonary Exacerbation includes events that are characterized by change or worsening pulmonary symptoms (increased cough, increased sputum production and chest congestion, decreased appetite and exercise tolerance), loss of weight, and lung function decline that prompt initation of antibiotic therapy. Protocol-defined exacerbations in subjects that warrant treatment with oral antibiotics will be determined from the medical record during the course of this study."}]}
{"nct_id":"NCT03006705","start_date":"2017-01-31","phase":"Phase 3","enrollment":700,"brief_title":"Study of Adjuvant ONO-4538 With Resected Gastric Cancer","official_title":"A Multicenter, Double-blind, Randomized Study in Patients With Gastric Cancer Undergoing Postoperative Adjuvant Chemotherapy","primary_completion_date":"2023-03-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-03-31","last_update":"2021-09-22","description":"The purpose of study is to evaluate the efficacy and safety of postoperative adjuvant chemotherapy with Nivolumab in combination with tegafur-gimeracil-oteracil potassium (S-1 therapy) or capecitabine + oxaliplatin (CapeOX therapy), in comparison with placebo in combination with S-1 therapy or CapeOX therapy, in pStage III gastric cancer (including esophagogastric junction cancer) after D2 or more extensive lymph node dissection.","other_id":"ONO-4538-38","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with histologically confirmed adenocarcinoma of the stomach\r\n\r\n          -  Patients without a remnant cancer (R0) who have undergone gastrectomy\r\n\r\n          -  Gastric carcinoma according to the stage classification of AJCC/UICC TNM\r\n             Classification, 7th Edition on the basis of overall postoperative findings\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who have received non-surgical treatment (e.g., radiotherapy, chemotherapy,\r\n             hormone therapy) for gastric cancer\r\n\r\n          -  Multiple primary cancers\r\n\r\n          -  A current or past history of severe hypersensitivity to any other antibody products\r\n\r\n          -  Any concurrent autoimmune disease or past history of chronic or recurrent autoimmune\r\n             disease\r\n      ","sponsor":"Ono Pharmaceutical Co. Ltd","sponsor_type":"Industry","conditions":"Gastric Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Nivolumab","description":"Nivolumab: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year)."},{"intervention_type":"Drug","name":"Drug: Tegafur-gimeracil-oteracil potassium","description":"Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off"},{"intervention_type":"Drug","name":"Drug: Oxaliplatin","description":"Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off."},{"intervention_type":"Drug","name":"Drug: Capecitabine","description":"Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year)."}],"outcomes":[{"outcome_type":"primary","measure":"Relapse-free survival (RFS)","time_frame":"5 years"},{"outcome_type":"secondary","measure":"Overall survival (OS)","time_frame":"5 years"},{"outcome_type":"secondary","measure":"3-year OS rate","time_frame":"3 years"},{"outcome_type":"secondary","measure":"5-year OS rate","time_frame":"5 years"},{"outcome_type":"secondary","measure":"3-year RFS rate","time_frame":"3 years"},{"outcome_type":"secondary","measure":"5-year RFS rate","time_frame":"5 years"},{"outcome_type":"secondary","measure":"Safety will be analyzed through the incidence of adverse events, serious adverse events","time_frame":"Up to 28 days from last dose"},{"outcome_type":"secondary","measure":"Safety will be analyzed through the incidence of laboratory abnormalities","time_frame":"Up to 28 days from last dose"}]}
{"nct_id":"NCT04542759","start_date":"2017-01-31","phase":"Phase 1","enrollment":60,"brief_title":"Effect of Topical Besifloxacin on Ocular Surface Bacterial Microbiota Prior to Cataract Surgery","official_title":"Effect of Topical Besifloxacin on Ocular Surface Bacterial Microbiota Prior to Cataract Surgery","primary_completion_date":"2017-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-04-30","last_update":"2020-09-09","description":"Describe the efficacy of the use of topical besifloxacin in reducing the conjunctival microbiota as a prophylactic measure in patients scheduled for cataract surgery.","other_id":"CI-004-215","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subjects over 18 years of age scheduled for cataract surgery in the established study\r\n             period.\r\n\r\n          -  Subjects physically and mentally capable of applying the eye drops or having a person\r\n             available to help in the correct administration of the eye drops 4 times a day.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  - Active eye infection (bacterial, viral, fungal or parasitic) such as blepharitis and\r\n             / or conjunctivitis.\r\n\r\n          -  Known allergy or any contraindication to the use of quinolones or any of the\r\n             components of the drugs.\r\n      ","sponsor":"Instituto de Oftalmologa Fundacin Conde de Valenciana","sponsor_type":"Other","conditions":"Microbial Disease|Cataract Senile","interventions":[{"intervention_type":"Drug","name":"Drug: Besifloxacin Ophthalmic","description":"Prophylaxis for endophthalmitis"},{"intervention_type":"Drug","name":"Drug: Hydroxypropyl Methylcellulose Ophthalmic Ophthalmic Solution","description":"Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of positive cultures before and after treatment in each arm","time_frame":"Through study completion, an average of 1 year","description":"A conjunctival cul-de-sac sample will be taken before starting treatment and before surgery, which will be cultured on 3 different media types: Blood, Chocolate and Sabouraud agar."}]}
{"nct_id":"NCT02685098","start_date":"2017-01-31","phase":"Phase 1","enrollment":16,"brief_title":"A Clinical and Histological Analysis of Mesenchymal Stem Cells in Amputation","official_title":"A Clinical and Histological Analysis of Mesenchymal Stem Cells in Amputation","primary_completion_date":"2021-09-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2025-09-30","last_update":"2020-02-12","description":"Patients undergoing semi-elective lower extremity major amputation from complications associated with atherosclerotic limb ischemia will received intra-muscular injections of allogeneic Mesenchymal Stromal Cells in the leg above and below the point of amputation to prevent ischemic wound complications after surgery and decrease the incidence of revision and further amputation.","other_id":"1505714405","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":40,"maximum_age":90,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Be  40 and 90 years of age.\r\n\r\n          2. Patients requiring lower extremity major amputation, as determined by an independent\r\n             vascular specialist.\r\n\r\n          3. If ulceration or gangrene present, it is distal to malleoli (to allow adequate length\r\n             of ATM area of approximately 3cm x 10cm x 3 cm)\r\n\r\n          4. Amputation can safely be performed up to 30 days after screening, as determined by an\r\n             independent vascular or orthopedic surgeon.\r\n\r\n          5. Females of childbearing potential must be willing to use one form of birth control for\r\n             the duration of the study. Female participants must undergo a blood or urine pregnancy\r\n             test at screening.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients who are pregnant, planning to become pregnant in the next 12 months, or\r\n             lactating.\r\n\r\n          2. Significant hepatic dysfunction (ALT or AST greater than 2 times normal).\r\n\r\n          3. CHF hospitalization within the last 1 month prior to enrollment.*\r\n\r\n          4. Acute coronary syndrome in the last 1 month prior to enrollment.*\r\n\r\n          5. HIV positive, or active, untreated HCV.\r\n\r\n          6. History of cancer within the last 5 years, except basal cell skin carcinoma\r\n\r\n          7. Any bleeding diathesis defined as an INR  2.0 (off anticoagulation therapy) or\r\n             history of platelet count less than 70,000 or hemophilia.\r\n\r\n          8. Inability to provide written informed consent due to cognitive or language barriers\r\n             (interpreter permitted).\r\n\r\n          9. Concurrent enrollment in another clinical investigative trial that may alter the\r\n             outcomes of enrollment in this trial.\r\n\r\n         10. Any condition requiring immunosuppressant medications (e.g., for treatment of organ\r\n             transplants, psoriasis, Crohn's disease, alopecia areata).\r\n\r\n         11. Presence of any clinical condition that in the opinion of the PI or the sponsor makes\r\n             the patient not suitable to participate in the trial.\r\n\r\n               -  As defined by the standard definitions of CHF and ACS by the American Heart\r\n                  Association.\r\n      ","sponsor":"Indiana University","sponsor_type":"Other","conditions":"Ischemia|Peripheral Arterial Disease|Peripheral Vascular Disease|Vascular Disease|Arterial Occlusive Disease|Arteriosclerosis|Atherosclerosis|Cardiovascular Disease|Pathologic Processes|Orthopedic Procedures|Amputation","interventions":[{"intervention_type":"Biological","name":"Biological: Allogeneic bone marrow derived mesenchymal stem cells","description":"Injection of HLA-A2+ and/or gender mismatched allogeneic MSCs above the site of amputation and into the anterior tibialis muscle (ATM) of patients scheduled for semi-elective lower extremity major amputation at 7 days before amputation."}],"outcomes":[{"outcome_type":"primary","measure":"Number of participants with treatment-related adverse events occurring during the enrollment period as assessed by the Investigator using the MeDRA scale.","time_frame":"Primary follow up in a 6 month period","description":"Treatment-related adverse events will be categorized in overlapping systems of cardiovascular, respiratory, or infectious and severities of serious adverse events (SAE) and major adverse cardiac events (MACE). The sum and difference between routes of delivery will be reported. Confidence intervals will be generated and summarize the data by the method of the Wilson Score Interval. Binomial confidence intervals at the 95% confidence level and p-values for these groups will be calculated. Continuous confidence intervals at the 95% level will be constructed to explore the effect of administration of MSCs on the composite endpoint at 6-months of death, amputation revision and gangrene, and will be compared to historical cohorts. The critical levels for the multiplicity adjustment will be determined by simple Monte Carlo simulation.Unanticipated SAEs and those affecting the rights, safety, or welfare of subjects will be documented and reported immediately upon discovery."},{"outcome_type":"secondary","measure":"Gene and protein arrays, IHC staining, and multiparametric flow cytometry will measure the time period of retention of allogeneic MSCs in harvested human skeletal muscle tissue post-MSC implantation.","time_frame":"Primary follow up in a 6 month period","description":"Quantities over time of MSC will be fit to an exponential decay curve using a residual pseudo-likelihood procedure and cell half-life (λ) will be estimated. Binomial confidence intervals at the 95% confidence level and p-values will be calculated for the presence or absence of MHC expression and SDF-1activation. The correlation between capillary density (CD31 counts) with tissue perfusion (ICA) for each time point will be estimated by Spearman's rank coefficient. The gene and protein expression profiles and histological findings will be used to test the hypotheses that MSCs have limited survival post-injection."},{"outcome_type":"secondary","measure":"Recruitment of proangiogenic hematopoietic cells into sites of ischemia will be measured and reported as assessed by the role of MSCs injected in human skeletal muscle at the time of amputation.","time_frame":"Primary follow up in a 6 month period","description":"Continuous confidence intervals at the 95% level will be constructed to explore differences among the time-tiered administration of MSC for (1) the CD34+CD133+ pro-angiogenic hematopoietic cells recruitment of HIF-1α/SDF-1/CXCR4 to ischemic muscle, (2) the quantify of capillary density in muscle fibers using hematoxylin phloxin saffron and CD31 counts, (3) VEGF-A,C,D, hepatocyte growth factor, angiopoietin-1 to characterize angiogenic cytokine expression, (4) percent coverage, fiber diameter and cross-sectional area to examine changes in morphology. The gene and protein expression profiles and histological findings will be used to test the hypotheses that MSCs act to recruit CD34+CD133+ proangiogenic hematopoietic cells."}]}
{"nct_id":"NCT03002909","start_date":"2017-01-31","phase":"N/A","enrollment":40,"brief_title":"Continuous Pre-peritoneal Wound Infiltration Versus Epidural Analgesia in Cancer Surgery","official_title":"Effect of Continuous Pre-peritoneal Wound Infiltration Versus Epidural Analgesia on Inflammatory Response and Pain Following Radical Cytsectomy","primary_completion_date":"2018-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-06-30","last_update":"2018-10-09","description":"the investigators aim is to investigate the effect of continuous preperitoneal bupivacaine wound infiltration versus epidural analgesia on the inflammatory cytokines response following radical cytectomy","other_id":"369","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  ASA I-III patients\r\n\r\n          -  aged 18-60 yr\r\n\r\n          -  undergo open abdominal cancer surgery\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  general contraindications for epidural analgesia,\r\n\r\n          -  recent history (8 weeks) of, chemotherapy or radiation,\r\n\r\n          -  chronic opioid use\r\n      ","sponsor":"Assiut University","sponsor_type":"Other","conditions":"Abdominal Neoplasms","interventions":[{"intervention_type":"Device","name":"Device: epidural catheter"},{"intervention_type":"Device","name":"Device: preperitoneal catheter"}],"outcomes":[{"outcome_type":"primary","measure":"changes in the level of inflammatory cytokines in pg /ml","time_frame":"24 hours","description":"Blood samples taken all over the 24-hr. period were collected in plasma tubes containing ethyl-enediamine-tetra-acectic (EDTA), centrifuged and stored at 20○c for assessment of Plasma concentrations plasma IL 1, IL 6, IL10 and TNF to assess inflammatory cytokines"},{"outcome_type":"secondary","measure":"Visual Analog Scale at rest and on coughing","time_frame":"24 hours","description":"pain intensity was assessed using a 10-cm VAS (0 = no pain and 10 = worst imaginable pain)"},{"outcome_type":"secondary","measure":"opioid side-effects","time_frame":"24 hours","description":"observation of side effects and record incidence as nausea, vomiting and itching"},{"outcome_type":"secondary","measure":"patient satisfaction","time_frame":"24 hours","description":"scale ranging 1-4 :unsatisfactory, regular, satisfactory and excellent)"}]}
{"nct_id":"NCT03036865","start_date":"2017-01-31","phase":"Phase 1","enrollment":61,"brief_title":"Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of BOS161721 in Healthy Subjects","official_title":"A Double-blind, Phase 1, Single Ascending Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of BOS161721 in Healthy Subjects","primary_completion_date":"2018-04-27","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-04-27","last_update":"2020-11-18","description":"Study BOS161721-01 is a randomized, single center, double-blind, placebo-controlled trial conducted to study the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending intravenous (IV) and subcutaneous (SC) doses of BOS161721 or placebo in healthy adult male and female participants.","other_id":"BOS161721-01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Participant voluntarily agrees to participate in this study and signs an Institutional\r\n             Review Board (IRB)-approved informed consent prior to performing any of the Screening\r\n             procedures\r\n\r\n          -  Participants should be between 18 and 55 years (both inclusive) of age at the time of\r\n             Screening, with a body mass index (BMI) between 17.5 and 32 kilograms per meters\r\n             squared (kg/m^2) (both inclusive) at the time of Screening, have a weight > 50 kg and\r\n             < 120 kg at the time of Screening, and be in general good health at least 8 weeks\r\n             prior to the Screening visit. Good health is defined as individuals without known\r\n             disease(s) as determined by a responsible physician, based on medical evaluation,\r\n             including medical history, physical examination, laboratory tests, imaging, and\r\n             cardiac monitoring.\r\n\r\n          -  Women of non-childbearing potential status:\r\n\r\n               -  Hysterectomy;\r\n\r\n               -  Bilateral tubal ligation/tubal occlusion;\r\n\r\n               -  Bilateral salpingectomy;\r\n\r\n               -  Bilateral oophorectomy;\r\n\r\n               -  Postmenopausal - defined as 12 months of spontaneous amenorrhea (In questionable\r\n                  cases, a blood sample will be taken with simultaneous testing of\r\n                  follicle-stimulating hormone (FSH) and estradiol levels, which should be\r\n                  consistent with menopausal range.)\r\n\r\n          -  Women of childbearing potential will be allowed to participate and have to agree to\r\n             use at least 1 of the following contraception methods at all times throughout study\r\n             participation in addition to either a condom with spermicide or a diaphragm/cervical\r\n             cap with spermicide:\r\n\r\n               -  Non-hormonal intrauterine device (IUD; Paragard/copper)\r\n\r\n               -  Hormonal IUD (Mirena)\r\n\r\n               -  Nexplanon or implantation - progesterone inserts under the skin\r\n\r\n          -  Males will either be sterile, agree to be abstinent from Day -1 through the last study\r\n             visit, or agree to use 2 highly effective methods of contraception such as:\r\n\r\n               -  A male condom with spermicide;\r\n\r\n               -  A sterile sexual partner;\r\n\r\n               -  Use by female sexual partner of an IUD with spermicide; a female condom with\r\n                  spermicide; contraceptive sponge with spermicide; an intravaginal system; a\r\n                  diaphragm with spermicide; a cervical cap with spermicide; or oral, implantable,\r\n                  transdermal, or injectable contraceptive(s).\r\n\r\n          -  Non-smokers or people who smoke up to 5 cigarettes per day but less than 10 packs per\r\n             year\r\n\r\n          -  Participants should be willing and able to comply with all study procedures. The\r\n             criterion for inclusion will be reviewed and verified at Screening and admission.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior clinical trial experience with monoclonal antibodies if there were clinically\r\n             relevant tolerability issues with previous administration or if a washout period of 60\r\n             days or 5 half-lives (whichever is longer) has not occurred prior to the planned first\r\n             day of dosing\r\n\r\n          -  History of any autoimmune disease (e.g., rheumatoid arthritis, Lupus)\r\n\r\n          -  History or current diagnosis of cancer, with the exception of non-melanoma skin cancer\r\n             or cervical cancer in situ treated with apparent success with curative therapy\r\n             (response duration > 5 years)\r\n\r\n          -  Asthma, currently treated with or in the opinion of the Principal Investigator likely\r\n             to require additional systemic glucocorticosteroid therapy during the study, is\r\n             exclusionary.\r\n\r\n          -  History of any clinically important drug or vaccine allergy or anaphylaxis\r\n\r\n          -  A cluster of differentiation 4 (CD4+) lymphocyte count < 500 cell/millimeters cubed\r\n             (mm^3) at Screening\r\n\r\n          -  Positive anti-keyhole limpet hemocyanin (KLH) antibodies at Screening\r\n\r\n          -  Previous immunization with KLH\r\n\r\n          -  Known allergy to shellfish, KLH vaccine, or hypersensitivity to proteins foreign to\r\n             the body\r\n\r\n          -  Levels of Immunoglobulin G (IgG) and Immunoglobulin M (IgM) outside of reference value\r\n             deemed clinically significant by the Principal Investigator at Screening\r\n\r\n          -  History or sensitivity to heparin or heparin-induced thrombocytopenia\r\n\r\n          -  Participants with cryptosporidium in the stool sample at Screening\r\n\r\n          -  Abnormal bilirubin or alanine aminotransferase (ALT) at Screening as judged by the\r\n             Principal Investigator to be clinically significant\r\n\r\n          -  Positive urine drug screen at Screening or Day -1\r\n\r\n          -  History of alcohol dependence as determined by a positive alcohol serum test at\r\n             Screening or Day -1 or participants who consume more than 14 (female participants) or\r\n             21 (male participants) units of alcohol a week (unit = 1 glass of wine [125\r\n             milliliters (mL)/4 ounces] = 1 measure [25 mL/1 ounce] of spirits = 284 mL [10 ounces]\r\n             of beer)\r\n\r\n          -  Participants who have a positive test, or have been treated, for Hepatitis A,\r\n             Hepatitis B, Hepatitis C virus, human immunodeficiency virus (HIV), cytomegalovirus\r\n             (CMV) or Epstein-Barr virus (EBV). Regarding Hepatitis B, any of the following would\r\n             exclude the participant from the study:\r\n\r\n               -  Participants with positive Hepatitis B Surface antigen (HBsAg);\r\n\r\n               -  Participants with Hepatitis B DNA levels > 200 copies/mL (quantified by real-time\r\n                  polymerase chain reaction) in case the participant is positive for Hepatitis B\r\n                  surface antibody (HBsAb) but negative for HBsAg;\r\n\r\n               -  Positive for Hepatitis B core antibody (HBcAb)\r\n\r\n          -  Current clinical, radiographic, or laboratory evidence of active tuberculosis (TB)\r\n\r\n          -  A history of active TB within the last 3 years before Screening, even if treated\r\n\r\n          -  Therapy for latent TB that has not been completed as per local country guidelines\r\n\r\n          -  Positive interferon gamma release assay (IGRA) for TB unless proper treatment is\r\n             documented, as described above\r\n\r\n          -  Donation of blood (> 500 mL) or blood products within 2 months (56 days) prior to Day\r\n             -1\r\n\r\n          -  Any medically relevant pre-existing condition that could jeopardize the safety of the\r\n             participant during the trial\r\n\r\n          -  Any participant, on the judgment of the Principal Investigator, who would be\r\n             considered unsuitable for the clinical trial\r\n\r\n          -  A shingles infection in the last 6 months prior to Screening\r\n\r\n          -  Live vaccination or use of steroids in the last 2 months prior to Screening\r\n\r\n          -  Use of prescription medications (except for oral contraceptive) and over-the-counter\r\n             treatments, including herbal supplements such as St. John's Wart (except\r\n             multivitamins), in the 2 weeks prior to Screening\r\n\r\n          -  Participants with poor dental health and/or severe foot fungal infections, as judged\r\n             by the Principal Investigator\r\n      ","sponsor":"Boston Pharmaceuticals","sponsor_type":"Industry","conditions":"Healthy Participants","interventions":[{"intervention_type":"Drug","name":"Drug: BOS161721","description":"Single dose administered IV or SC"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Single dose administered IV or SC"}],"outcomes":[{"outcome_type":"primary","measure":"Number of participants with any treatment-emergent serious adverse event (TESAE)","time_frame":"up to 52 weeks"},{"outcome_type":"primary","measure":"Number of participants with any treatment-emergent non-serious adverse event (TEAE)","time_frame":"up to 52 weeks"},{"outcome_type":"primary","measure":"Number of participants with TESAEs of the indicated severity","time_frame":"up to 52 weeks"},{"outcome_type":"primary","measure":"Number of participants with TEAEs of the indicated severity","time_frame":"up to 52 weeks"},{"outcome_type":"primary","measure":"Number of participants with abnormal, clinically significant electrocardiogram findings","time_frame":"Days -1 and 4 (Residential Period); Days 15, 30, and 90 (Follow-up Period)","description":"Single-day dosing will occur on Day 1."},{"outcome_type":"primary","measure":"Number of participants with abnormal, clinically significant vital sign (blood pressure, heart rate, temperature) values","time_frame":"Screening; Days -1, 1, 2, 4, and 7 (Residential Period); Days 15, 30, 44, 60, 90, 180, 210, 270, and 360 (Follow-up Period)","description":"Single-day dosing will occur on Day 1."},{"outcome_type":"primary","measure":"Number of participants with abnormal, clinically significant hematology parameter values","time_frame":"Screening; Days -1, 1, 2, 4, and 7 (Residential Period); Days 15, 30, 44, 60, 90, 180, 210, 270, and 360 (Follow-up Period)","description":"Single-day dosing will occur on Day 1."},{"outcome_type":"primary","measure":"Number of participants with abnormal, clinically significant clinical chemistry parameter values","time_frame":"Screening; Days -1, 1, 2, 4, and 7 (Residential Period); Days 15, 30, 44, 60, 90, 180, 210, 270, and 360 (Follow-up Period)","description":"Single-day dosing will occur on Day 1."},{"outcome_type":"primary","measure":"Mean total immunoglobulin G (IgG) levels","time_frame":"Screening; Days -1 and 4 (Residential Period); Days 15, 30, 60, 210 and 270 (Follow-up Period)","description":"Single-day dosing will occur on Day 1."},{"outcome_type":"primary","measure":"Mean total immunoglobulin M (IgM) levels","time_frame":"Screening; Days -1 and 4 (Residential Period); Days 15, 30, 60, 210 and 270 (Follow-up Period)","description":"Single-day dosing will occur on Day 1."},{"outcome_type":"primary","measure":"Mean cluster of differentiation 4 (CD4+) cell count","time_frame":"Screening; Days -1, 4, and 7 (Residential Period); Days 15, 30, 44, 60, 90, 180, 210, 270, and 360 (Follow-up Period)","description":"Single-day dosing will occur on Day 1."},{"outcome_type":"primary","measure":"Number of participants with abnormal, clinically significant physical examination findings","time_frame":"Screening; Day -1 (Residential Period)","description":"Single-day dosing will occur on Day 1."},{"outcome_type":"primary","measure":"Number of participants with abnormal, clinically significant targeted physical examination findings","time_frame":"Day 7 (Residential Period); Days 15, 44, 90, 180, 270, and 360 (Follow-up Period)","description":"Single-day dosing will occur on Day 1."},{"outcome_type":"secondary","measure":"Mean maximum observed concentration (Cmax) of intravenous (IV) BOS161721","time_frame":"Day 1 of Cohorts 1 and 6: predose, at the end of infusion/injection (30 minutes); at 0.5, 1, 2, 4, 8, and 12 hours postdose. Postdose on Days 2, 4, 7, 15, 30, 44, 90, 180, 210, 270, and 360 for Cohorts 1 and 6."},{"outcome_type":"secondary","measure":"Mean Cmax of subcutaneous (SC) BOS161721","time_frame":"Day 1 of Cohorts 2, 3, 4, 5, 7, and 8: predose; following subcutaneous injection on Day 1. Postdose on Days 2, 4, 7, 15, 30, 44, 90, 180, 210, 270, and 360 for Cohorts 2, 3, 4, 5, 7, and 8."},{"outcome_type":"secondary","measure":"Mean first time to maximum concentration (Tmax) of IV BOS161721","time_frame":"Day 1 of Cohorts 1 and 6: predose, at the end of infusion/injection (30 minutes); at 0.5, 1, 2, 4, 8, and 12 hours postdose. Postdose on Days 2, 4, 7, 15, 30, 44, 90, 180, 210, 270, and 360 for Cohorts 1 and 6."},{"outcome_type":"secondary","measure":"Mean Tmax of SC BOS161721","time_frame":"Day 1 of Cohorts 2, 3, 4, 5, 7, and 8: predose; following subcutaneous injection on Day 1. Postdose on Days 2, 4, 7, 15, 30, 44, 90, 180, 210, 270, and 360 for Cohorts 2, 3, 4, 5, 7, and 8."},{"outcome_type":"secondary","measure":"Mean area under the concentration-time curve (AUC) of IV BOS161721","time_frame":"Day 1 of Cohorts 1 and 6: predose, at the end of infusion/injection (30 minutes); at 0.5, 1, 2, 4, 8, and 12 hours postdose. Postdose on Days 2, 4, 7, 15, 30, 44, 90, 180, 210, 270, and 360 for Cohorts 1 and 6."},{"outcome_type":"secondary","measure":"Mean AUC of SC BOS161721","time_frame":"Day 1 of Cohorts 2, 3, 4, 5, 7, and 8: predose; following subcutaneous injection on Day 1. Postdose on Days 2, 4, 7, 15, 30, 44, 90, 180, 210, 270, and 360 for Cohorts 2, 3, 4, 5, 7, and 8."},{"outcome_type":"secondary","measure":"Mean terminal elimination half-life (t½) of IV BOS161721","time_frame":"Day 1 of Cohorts 1 and 6: predose, at the end of infusion/injection (30 minutes); at 0.5, 1, 2, 4, 8, and 12 hours postdose. Postdose on Days 2, 4, 7, 15, 30, 44, 90, 180, 210, 270, and 360 for Cohorts 1 and 6."},{"outcome_type":"secondary","measure":"Mean t½ of SC BOS161721","time_frame":"Day 1 of Cohorts 2, 3, 4, 5, 7, and 8: predose; following subcutaneous injection on Day 1. Postdose on Days 2, 4, 7, 15, 30, 44, 90, 180, 210, 270, and 360 for Cohorts 2, 3, 4, 5, 7, and 8."},{"outcome_type":"secondary","measure":"Mean systematic clearance (CL) of IV BOS161721","time_frame":"Day 1 of Cohorts 1 and 6: predose, at the end of infusion/injection (30 minutes); at 0.5, 1, 2, 4, 8, and 12 hours postdose. Postdose on Days 2, 4, 7, 15, 30, 44, 90, 180, 210, 270, and 360 for Cohorts 1 and 6."},{"outcome_type":"secondary","measure":"Mean CL of SC BOS161721","time_frame":"Day 1 of Cohorts 2, 3, 4, 5, 7, and 8: predose; following subcutaneous injection on Day 1. Postdose on Days 2, 4, 7, 15, 30, 44, 90, 180, 210, 270, and 360 for Cohorts 2, 3, 4, 5, 7, and 8."},{"outcome_type":"secondary","measure":"Mean volume of distribution (Vd) of IV BOS161721","time_frame":"Day 1 of Cohorts 1 and 6: predose, at the end of infusion/injection (30 minutes); at 0.5, 1, 2, 4, 8, and 12 hours postdose. Postdose on Days 2, 4, 7, 15, 30, 44, 90, 180, 210, 270, and 360 for Cohorts 1 and 6."},{"outcome_type":"secondary","measure":"Mean Vd of SC BOS161721","time_frame":"Day 1 of Cohorts 2, 3, 4, 5, 7, and 8: predose; following subcutaneous injection on Day 1. Postdose on Days 2, 4, 7, 15, 30, 44, 90, 180, 210, 270, and 360 for Cohorts 2, 3, 4, 5, 7, and 8."},{"outcome_type":"secondary","measure":"Number of participants with anti-drug antibodies (ADA) to BOS161721","time_frame":"up to Day 60"}]}
{"nct_id":"NCT02811172","start_date":"2017-01-31","enrollment":224,"brief_title":"Behavior of Biomarkers During Pregnancy and Lactation Through a Biological Multi-paradigm Model: BECOME Study Protocol","official_title":"Behavior of Biomarkers During Pregnancy and Lactation Through a Biological Multi-paradigm Model: BECOME Study Protocol","primary_completion_date":"2018-08-31","study_type":"Observational","rec_status":"Completed","completion_date":"2019-01-31","last_update":"2019-02-25","description":"Background Despite of advances in research, at the moment, various points related to the physiology of gestation and the etiology of severe diseases that can be developed in the course of it remain unknown. One of those aspects is the behavior of biomarkers (triglycerides, prolactin, glucose and cholesterol) during pregnancy, which experience a gradual increase in their levels until they reach the peak of hypertriglyceridemia, a few days before delivery. Several studies have reported that biomarkers experience a higher elevation in diabetic and obese pregnant women and in those women who suffer preeclampsia. The description of their behavior in different population of pregnant women (healthy women and women at risk) would identify the relation of these with some of the alterations that occurs more frequently during pregnancy. Objective The aim of this study is to develop a multi-paradigm biological model of systems to determine triglyceride, prolactin, glucose and cholesterol levels during pregnancy and its relation with lactogenesis in healthy and risk pregnant women. Methods A prospective cohort study will take place with women during pregnancy and lactation. Participating women will be divided into two groups. One group will be integrated by healthy women and the other group by pregnant women with a risk medical history. The personal, family and a detailed medical history will be collected in each group. A study of all the variables which influence the level of the mentioned biomarkers (triglycerides, cholesterol, glucose and prolactin) will be done. The universe consists in 4,300 women, who constitute the historical average deliveries during the semester in the city of Granada (Spain). The sample collection will be made in medical office's pregnancy control in Granada's hospitals, in their respective health centers and during the second half of 2015. The sample will be stratified and probabilistic. Peculiarities of pregnant women will be taken into account when calculating the size of the study sample. This sample will be made up of 224 women who comply with the inclusion criteria and that have signed the informed consent. To achieve the project objectives an organization comprising six theoretical and practical phases enabling the scientific development of the project. During the first phase, the technical and administrative preparation of the project is constructed. Thereafter, the work is divided into two action areas which encompass the collection and data modeling. The creation of a biological multi-paradigm computer simulation model of the levels of biomarkers in different months of pregnancy and in the various pathologies of pregnant women can be very effective to know the risks that involve high levels of lipids for the mother and for the baby.","other_id":"SPID201600X080546IV0","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"Female","population":"The universe is composed by 4300 women that constitute the historical average of deliveries\r\n        during a semester in the city of Granada (Spain). The research is projected over women that\r\n        attend to the pregnancy control consultation into Granada's hospitals during the second\r\n        semester of 2015. The sample is probabilistic and stratified. To calculate the size of the\r\n        sample they were considered the characteristics of pregnant women that to be formed by 224\r\n        women that comply with the inclusion criteria and that sign the informed consent.","criteria":"\n        Exclusion criteria\r\n\r\n          -  Impossibility to participate in the research.\r\n\r\n          -  Restrictive pulmonary disease.\r\n\r\n          -  Cardiac pathology with hemodynamic repercussion.\r\n\r\n          -  Familiar hyperlipidemia.\r\n\r\n          -  Multiple pregnancies.\r\n\r\n        Inclusion criteria\r\n\r\n         Pregnant women healthy and with risk that want participate in a voluntary way in the\r\n        research and sign the informed consent.\r\n      ","sponsor":"Universidad de Granada","sponsor_type":"Other","conditions":"Pregnancy|Gestational Diabetes|Hypertension|Obesity","interventions":[{"intervention_type":"Other","name":"Other: BEhavior of biomarkers during pregnanCy and lactatiOn"}],"outcomes":[{"outcome_type":"primary","measure":"Triglyceride levels","time_frame":"18 months","description":"Begins in the 20 weeks and ended 20 days after delivery. Since the 37 week is taken each 72 hours and then daily when an increase of the values occurs and it's followed until 20 days after delivery.\r\nMeasures during this stage are performed with the reagent disk Piccolo®, using the blood analyzer Piccolo express™. It is designed for using in quantitative determination \"in vitro\" of the total cholesterol, High Density Lipoproteins and triglycerides in a clinic laboratory.\r\nThe levels of normality have been stablished to the following biomarkers:\r\nTriglycerides levels: under 150 mg/dl, with a high limit between 155 and 199 mg/dl and higher between 200 and 499 mg/dl. During pregnancy it is recommended to keep it under 300 mg/dl."},{"outcome_type":"primary","measure":"prolactin levels","time_frame":"18 months","description":"Prolactin: 10- 209 ng/ml."},{"outcome_type":"primary","measure":"glucose levels","time_frame":"18 months","description":"Gestational diabetes: it is diagnose when in the O'Sullivan test the values are equal or superior to the following: blood sugar 105 mg/dl; 1 hour,190 mg/dl; 2 hours, 165 mg/dl and 3 hours, 145 mg/dl."},{"outcome_type":"primary","measure":"cholesterol levels","time_frame":"18 months","description":"To determine the values of total cholesterol, HDL, LDL and triglycerides the samples should be taken after 8 or 12 hours without eating.\r\nThe test begins after 10 minutes of transferring the sample to the disk. The levels of normality are:\r\nTotal cholesterol: under 200 mg/dl. LDL cholesterol: 40-60 mg/dl, values under 40 mg/dl indicate a higher risk of cardiovascular disease."},{"outcome_type":"primary","measure":"Nutritional evaluation","time_frame":"3 months","description":"In the first interview to the pregnant woman and after the sign of the informed consent the medical record is performed. Nutritional evaluation is carry out through a validate survey that was published in 2012 by our research team (González Jiménez et al., 2012).\r\nBioelectrical impedance was also performed. In clinical history socio demographics variables personal and familiars were collected and anxiety and depressive test were performed (Snaith & Zigmond, 1983)."},{"outcome_type":"primary","measure":"Collection of samples: mother's milk","time_frame":"6 months","description":"It is about to follow the evolution of the process of lactation and the quality of mother's milk. In each group of study three samples are collected: colostrum (2 to 6 days after delivery); transition milk (7 to 21 days after delivery) and maturing milk (after 21 days of delivery).\r\nLactogenesis is the process that begins with milk secretion. It is stablished between 24 hours and the sixth day after delivery and is a consequence of the action of prolactin and the low estrogenic level. Before delivery, PRL levels increase but the estrogens of placenta blocked the secretion of glands. The maintaining of lactation requires a continuous suction of the nipple. The estrogenic fall after delivery allows unblock or mammary tissue."},{"outcome_type":"secondary","measure":"Mother's milk: short-chain fatty acid","time_frame":"6 months","description":"According technique developed by the Research Department of Nutrition and Food Science (Journal of Chemistry.2014 ) by gas chromatography using a Perkin Elmer Autosystem gas chromatograph ( Perkin -Elmer , Norwalk , CT , USA ) , equipped with a detector flame ionization (FID ) and a capillary column Supelco 2380 TVSS (30 m × 0.25 mm id , 0.2 um film thickness) ."},{"outcome_type":"secondary","measure":"Mother's milk: Total fatty acid profile","time_frame":"6 months","description":"Mass spectrometry using low resolution [ MSP ] with triple quadrupole analyzer (triple -quad ) WATERS model QUATTRO and micro GC Gas Chromatograph model 7890A AGILET , with injectors split / splitless and PTV for capillary columns . Servicos Central Scientific Instrumentation of the UGR ( http://cic.ugr.es/ )"},{"outcome_type":"secondary","measure":"Bioactive peptides","time_frame":"6 months","description":"For purification of the peptides the whey are subjected to ion exchange using Dowex 50WX2 resin in the column ( 2.6 x 10 cm , H + -form , 200-400 mesh , Serva , Heidelberg , Germany) according to the procedure described by Farvin et al., 2010 ."}]}
{"nct_id":"NCT03008473","start_date":"2017-01-31","phase":"N/A","enrollment":70,"brief_title":"Chest CT for the Placement of the Uniblocker","official_title":"Placement of the Uniblocker Under the Guidence of Chest Computerized Tomography","primary_completion_date":"2017-09-24","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-09-24","last_update":"2018-02-23","description":"Video laryngoscope and chest CT iminge for the placement of the Uniblocker","other_id":"20161229","allocation":"Randomized","intervention_model":"Factorial Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        BMI less than 35 kg/m2 ASA classifications of I-III, Modified Mallampati classification 1\r\n        or 2 Under general anesthesia\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Age younger than 18 yr or older than 65 yr\r\n\r\n          -  ASA class IV or V\r\n\r\n          -  Abnormalities of the heart, brain, liver, lung, kidney and coagulation functions\r\n      ","sponsor":"The First Hospital of Qinhuangdao","sponsor_type":"Other","conditions":"Therapeutic Procedural Complication","interventions":[{"intervention_type":"Device","name":"Device: video laryngoscope and chest CT iminge"},{"intervention_type":"Device","name":"Device: Conventional intubation of uniblocker"}],"outcomes":[{"outcome_type":"primary","measure":"Intubation Time","time_frame":"5min"}]}
{"nct_id":"NCT02589782","start_date":"2017-01-31","phase":"Phase 2/Phase 3","enrollment":552,"brief_title":"Pragmatic Clinical Trial for a More Effective Concise and Less Toxic MDR-TB Treatment Regimen(s)","official_title":"A Randomised, Controlled, Open-Label, Phase II-III Trial to Evaluate the Safety and Efficacy of Regimens Containing Bedaquiline and Pretomanid for the Treatment of Adult Patients With Pulmonary Multidrug Resistant Tuberculosis","primary_completion_date":"2022-09-30","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2022-12-31","last_update":"2021-05-14","description":"TB PRACTECAL is a multi-centre, open label, multi-arm, randomised, controlled, phase II-III trial; evaluating short treatment regimens containing bedaquiline and pretomanid in combination with existing and re-purposed anti-TB drugs for the treatment of biologically confirmed pulmonary multi drug-resistant TB (MDR-TB).","other_id":"1541","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":15,"population":"","criteria":"\n        Inclusion criteria:\r\n\r\n        Patients eligible for inclusion in the trial must fulfil all of the following criteria:\r\n\r\n          -  Male or female subjects aged 15 years of age or above, regardless of HIV status;\r\n\r\n          -  Microbiological test (molecular or phenotypic) confirming presence of M. tuberculosis;\r\n\r\n          -  Resistant to at least rifampicin by either molecular or phenotypic drug susceptibility\r\n             test;\r\n\r\n          -  Completed informed consent form (ICF);\r\n\r\n        Exclusion criteria:\r\n\r\n        Patients will not be eligible for inclusion in the trial if they meet any of the following\r\n        criteria:\r\n\r\n          -  Known allergies, hypersensitivity, or intolerance to any of the study drugs;\r\n\r\n          -  Pregnant or breast-feeding; or unwilling to use appropriate contraceptive measures\r\n\r\n          -  Liver enzymes >3 times the upper limit of normal (AST or ALT);\r\n\r\n          -  Any condition (social or medical) which, in the opinion of the investigator, would\r\n             make study participation unsafe;\r\n\r\n          -  Taking any medications contraindicated with the medicines in the trial;\r\n\r\n          -  QTcF > 450ms;\r\n\r\n          -  One or more risk factors for QT prolongation (excluding age and gender) or other\r\n             uncorrected risk factors for TdP;\r\n\r\n          -  History of cardiac disease, syncopal episodes, symptomatic or asymptomatic arrhythmias\r\n             (with the exception of sinus arrhythmia);\r\n\r\n          -  Any baseline biochemical laboratory value consistent with Grade 4 toxicity.\r\n\r\n          -  Moribund\r\n\r\n          -  Known resistance to bedaquiline, pretomanid, delamanid or linezolid.\r\n\r\n          -  Prior use of bedaquiline and/or pretomanid and/or linezolid and/or delamanid for one\r\n             or more months.\r\n\r\n          -  Patients not eligible to start a new course of MDR-TB/XDR-TB treatment according to\r\n             local protocol, including but not limited to:\r\n\r\n               -  currently on MDR-TB treatment for more than 2 weeks (and not failing)\r\n\r\n               -  unstable address\r\n\r\n               -  loss to follow-up in previous treatment with no change in circumstance and\r\n                  motivation.\r\n\r\n          -  Tuberculous meningoencephalitis, brain abscesses, osteomyelitis or arthritis.\r\n\r\n        PKPD inclusion/exclusion:\r\n\r\n          -  Adult patients (aged 18 years or above) recruited into the investigational arms of the\r\n             TB-PRACTECAL trial in the approved sites.\r\n\r\n          -  Willing to sign the sub-study informed consent form after agreeing to the additional\r\n             blood draws.\r\n      ","sponsor":"Medecins Sans Frontieres, Netherlands","sponsor_type":"Other","conditions":"Tuberculosis, Multidrug-Resistant|Extensively Drug-Resistant Tuberculosis|Tuberculosis, Pulmonary","interventions":[{"intervention_type":"Drug","name":"Drug: Bedaquiline"},{"intervention_type":"Drug","name":"Drug: Pretomanid"},{"intervention_type":"Drug","name":"Drug: Moxifloxacin"},{"intervention_type":"Drug","name":"Drug: Linezolid"},{"intervention_type":"Drug","name":"Drug: Clofazimine"},{"intervention_type":"Drug","name":"Drug: Locally accepted standard of care which is consistent with the WHO recommendations for the treatment of M/XDR-TB."}],"outcomes":[{"outcome_type":"secondary","measure":"Stage 1:Percentage of patients experiencing at least one new grade 3 or higher Adverse Event","time_frame":"within 8 weeks post randomisation"},{"outcome_type":"primary","measure":"Stage 1:Percentage of patients with culture conversion in liquid media at 8 weeks post randomisation.","time_frame":"8 weeks post randomisation"},{"outcome_type":"primary","measure":"Stage 1: Percentage of patients who discontinue treatment for any reason or die","time_frame":"8 weeks post randomisation"},{"outcome_type":"primary","measure":"Stage 2: Percentage of patients with an unfavourable outcome (failure, death, recurrence, loss to follow-up)","time_frame":"72 weeks post-randomisation"},{"outcome_type":"secondary","measure":"Stage 1: Percentage of patients with grade 3 or higher QT prolongation","time_frame":"within 8 weeks post randomisation"},{"outcome_type":"secondary","measure":"Stage 1: Percentage of patients experiencing at least one Serious Adverse Event (SAE)","time_frame":"within 8 weeks post randomisation"},{"outcome_type":"secondary","measure":"Stage 2: Percentage of patients with culture conversion","time_frame":"12 weeks post randomisation"},{"outcome_type":"secondary","measure":"Stage 2: Percentage of patients with an unfavourable outcome (i.e. failure, treatment discontinuation, death, loss to follow up)","time_frame":"24 weeks post randomisation"},{"outcome_type":"secondary","measure":"Stage 2: Percentage of patients with an unfavourable outcome (i.e. failure, treatment discontinuation, death, loss to follow up, still on treatment at censure and recurrence)","time_frame":"108 weeks post randomisation"},{"outcome_type":"secondary","measure":"Stage 2: Median time to culture conversion","time_frame":"108 weeks"},{"outcome_type":"secondary","measure":"Stage 2: Percentage of patients with an SAE or new grade 3 or higher AE","time_frame":"72 weeks post randomisation"},{"outcome_type":"secondary","measure":"Stage 2: Percentage of patients with an SAE or new grade 3 or higher AE","time_frame":"108 weeks post randomisation"},{"outcome_type":"secondary","measure":"Stage 2: Percentage of patients with an SAE or new grade 3 or higher AE at the end of treatment","time_frame":"24 weeks in investigational arms and 108 weeks in SOC arm","description":"The percentage of patients with an SAE or new grade 3 or higher AE at the end of treatment in the investigational arms (maximum of 24 weeks) and the SOC arm which varies in length (maximum 108 weeks)."},{"outcome_type":"secondary","measure":"Stage 2: Mean single ΔQTcF","time_frame":"24 weeks post randomisation"},{"outcome_type":"secondary","measure":"Stage 2: Percentage of patients experiencing recurrence","time_frame":"week 48 in investigational arms"},{"outcome_type":"secondary","measure":"Stage 2: Plasma drug concentrations","time_frame":"In relation to dose intake and start of treatment over a 72 week period"},{"outcome_type":"secondary","measure":"Stage 2: TB drug hair levels","time_frame":"In relation to dose intake and start of treatment over a 72 week period"}]}
{"nct_id":"NCT03009747","start_date":"2017-01-31","enrollment":460,"brief_title":"A Prospective Multi-Center Research on Bowel Dysfunction After Sphincter Preservative Surgery","official_title":"A Prospective, Randomization and Clinic Cohort Observational Study From Multi Institutions on Bowel Dysfunction Following Surgery for Rectal Cancers With Sphincter Preservation","primary_completion_date":"2018-12-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2019-12-31","last_update":"2017-01-04","description":"This research plans to collect rectal cancer patients after sphincter-preserving surgery from 14 institutions in China mainland, observe the incidence and risk factors about bowel dysfunction after operation.","other_id":"BaS-1611","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Rectal cancer patients who accept sphincter-preserving surgery","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age  18 years\r\n\r\n          2. Adenocarcinoma confirmed by pathology\r\n\r\n          3. Distance from the lowest margin of tumor to the anal verge is  12cm, confirmed by\r\n             hard sigmoidoscope.\r\n\r\n          4. The tumor is estimated to be resectable and confirmed by multidisciplinary team (MDT).\r\n\r\n          5. The operation is estimated to be sphincter-preserving.\r\n\r\n          6. The Eastern Cooperative Oncology Group(ECOG) performance status score of patient is \r\n             2.\r\n\r\n          7. The estimated life time is not less than one year.\r\n\r\n          8. The patient agree to sign the informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. The patient refuse to follow research plan.\r\n\r\n          2. Emergency case\r\n\r\n          3. Pregnant and lactating female patient\r\n\r\n          4. The patient did not accept radical resection.\r\n\r\n          5. The patient did not accept first stage resection and anastomosis.\r\n\r\n          6. The patient has experienced anal-rectal surgery.\r\n\r\n          7. The patient has experienced left colon surgery.\r\n\r\n          8. The patient suffered long-existing bowel dysfunction before rectal cancer diagnosis.\r\n\r\n          9. The patient was diagnosed with cognitive or communicative obstacles.\r\n\r\n         10. The patient was diagnosed with serious repeated infection or other concomitance\r\n             diseases.\r\n\r\n         11. The patient has participated other medical research which may affect his/her bowel\r\n             function.\r\n      ","sponsor":"Peking University People's Hospital","sponsor_type":"Other","conditions":"Bowel Dysfunction|Rectal Cancer","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Incidence of bowel dysfunction after sphincter-preserving surgery","time_frame":"one year"},{"outcome_type":"primary","measure":"Risk factors of bowel dysfunction after sphincter-preserving surgery","time_frame":"one year"},{"outcome_type":"secondary","measure":"Incidence of each symptoms of bowel dysfunction","time_frame":"one year"},{"outcome_type":"secondary","measure":"Prognosis of bowel dysfunction after sphincter-preserving surgery","time_frame":"one year"},{"outcome_type":"secondary","measure":"Incidence of bowel dysfunction after sphincter-preserving surgery","time_frame":"one year","description":"comparing incidences between high and low anastomsis site"}]}
{"nct_id":"NCT02752893","start_date":"2017-01-30","enrollment":10,"brief_title":"Estrogen Receptor-Positive Breast Cancer Patient-Derived Xenografts","official_title":"Estrogen Receptor-Positive Breast Cancer Patient-Derived Xenografts","primary_completion_date":"2019-04-03","study_type":"Observational","rec_status":"Completed","completion_date":"2019-04-03","last_update":"2020-06-01","description":"The investigators will establish a platform at Dartmouth-Hitchcock Medical Center to generate novel models of estrogen receptor alpha-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer, which will be used for research studies to develop novel treatment strategies and dissect signaling pathways underlying drug sensitivity and resistance.","other_id":"D16100","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Subjects >18 years of age with disease progression during neoadjuvant therapy, recurrence\r\n        after neoadjuvant or adjuvant therapy, or progression after systemic therapy for metastatic\r\n        disease that expresses estrogen receptor alpha (ER+) and does not overexpress HER2 (HER2-,\r\n        HER2-negative).\r\n\r\n        Subjects must be scheduled to undergo a clinically indicated biopsy or surgical removal of\r\n        tumor, and excess tumor tissue must be available for research use.","criteria":"\n        Inclusion criteria\r\n\r\n          1. Men and women > age 18 with histologically documented ER+/HER2- breast cancer or with\r\n             a history of ER+/HER2- breast cancer, for whom a tumor biopsy or surgical resection is\r\n             clinically indicated and will be performed as standard of care.\r\n\r\n             Tumor specimens may be from breast (progressive or recurrent) or metastatic sites.\r\n             Patients with multicentric or bilateral disease are eligible.\r\n\r\n          2. Patients must have disease progression during neoadjuvant therapy, recurrence after\r\n             neoadjuvant or adjuvant therapy, or progression after systemic therapy for metastatic\r\n             disease.\r\n\r\n          3. ER positivity is defined as >10% of malignant tumor cells staining positively for ER\r\n             by immunohistochemistry (IHC).\r\n\r\n             HER2 negativity is defined as IHC 0-1+, or with a fluorescence in situ hybridization\r\n             (FISH) ratio of <1.8 if IHC is 2+ or if IHC has not been done.\r\n\r\n          4. Excess LIVE tumor tissue must be available from the surgically resected tumor\r\n             specimen, or from 1-3 extra core needle or incisional biopsy. LIVE tumor tissue must\r\n             be available within 2 hours of removal from patient (shorter time is preferable).\r\n\r\n          5. A recurrent or progressing breast cancer must be greater than 1 cm in greatest\r\n             diameter.\r\n\r\n          6. Prior therapy is allowed as long as excess viable tumor tissue is available from the\r\n             biopsy or surgical excision procedure.\r\n\r\n          7. Patients must be willing to provide 6 mL of blood, which can be obtained during a\r\n             routine clinically indicated blood draw (ideally, done on the same day as the tumor\r\n             biopsy/surgery).\r\n\r\n          8. Ability to give signed informed consent.\r\n\r\n        Exclusion Criteria\r\n\r\n        1. Fine needle aspirates and effusions of bodily fluids are not eligible as sources of\r\n        tumor cells.\r\n      ","sponsor":"Dartmouth-Hitchcock Medical Center","sponsor_type":"Other","conditions":"Breast Cancer","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Xenograft success rate, defined as the percentage of patient tumors that yield a growing xenograft in mice.","time_frame":"1 year from time of surgery"}]}
{"nct_id":"NCT03443011","start_date":"2017-01-19","phase":"N/A","enrollment":149,"brief_title":"Diagnostics in Diverticulitis (DIDit)","official_title":"Diagnostics in Diverticulitis (DIDit)","primary_completion_date":"2018-01-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-03-01","last_update":"2018-05-03","description":"This study focuses on if low dose CT without intravenous contrast has a high enough specificity and sensitivity for acute diverticulitis that it can be used as the primary diagnostic method instead of a full dose CT with intravenous contrast which is the standard method in Sweden.","other_id":"Dnr 2016/411","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Over the age of 50\r\n\r\n          -  Clinically suspected acute diverticulitis\r\n\r\n          -  Low abdominal pain\r\n\r\n          -  WBC over 10 x 109/L or raised C-reactive protein levels 25 mg/L\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnancy\r\n\r\n          -  Previous allergy to intravenous contrast\r\n\r\n          -  Renal failure or other reasons that the patient cannot undergo CT with iv contrast\r\n\r\n          -  Unable to give informed consent\r\n\r\n          -  Dementia\r\n\r\n          -  Language barrier\r\n      ","sponsor":"Uppsala University","sponsor_type":"Other","conditions":"Diverticulitis","interventions":[{"intervention_type":"Radiation","name":"Radiation: Low dose CT without intravenous contrast","description":"participants will receive an extra radiation dosage of about 3 milli Sievert (mSv) depending on patients height and weight. This is the radiation amount from the low dose CT protocol without intravenous contrast."}],"outcomes":[{"outcome_type":"primary","measure":"Presence of diverticulitis on low dose CT and/or full dose CT","time_frame":"Baseline","description":"Colonic wall thickening >5mm, pericolic fat stranding and diverticula on CT"}]}
{"nct_id":"NCT02692716","start_date":"2017-01-17","phase":"Phase 3","enrollment":3183,"brief_title":"A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes","official_title":"A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes","primary_completion_date":"2018-09-25","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-09-25","last_update":"2021-01-14","description":"This trial is conducted globally. The aim of the trial is to investigate the cardiovascular safety of oral semaglutide in subjects with type 2 diabetes.","other_id":"NN9924-4221","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female diagnosed with type 2 diabetes\r\n\r\n          -  Age at least 50 years at screening and presence of cardiovascular disease, or age at\r\n             least 60 years at screening and presence of at least one cardiovascular risk factor\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Current or previous (within 90 days prior to screening) treatment with any GLP-1\r\n             (glucagon-like peptide-1) receptor agonist, DPP-4 (dipeptidyl peptidase-4) inhibitor\r\n             or pramlintide\r\n\r\n          -  Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary\r\n             thyroid carcinoma (MTC)\r\n\r\n          -  History of pancreatitis (acute or chronic)\r\n\r\n          -  History of major surgical procedures involving the stomach potentially affecting\r\n             absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy,\r\n             gastric bypass surgery)\r\n\r\n          -  Subjects presently classified as being in New York Heart Association (NYHA) Class IV\r\n             heart failure\r\n\r\n          -  Planned coronary, carotid or peripheral artery revascularisation known on the day of\r\n             screening\r\n\r\n          -  Any of the following: myocardial infarction, stroke or hospitalisation for unstable\r\n             angina or transient ischaemic attack within the past 60 days prior to screening\r\n\r\n          -  Chronic or intermittent hemodialysis or peritoneal dialysis or severe renal impairment\r\n             (corresponding to eGFR (glomerular filtration rate, estimated) below 30 mL/min/1.73\r\n             m^2)\r\n\r\n          -  History or presence of malignant neoplasms within the last 5 years (except basal and\r\n             squamous cell skin cancer and carcinoma in situ)\r\n      ","sponsor":"Novo Nordisk A/S","sponsor_type":"Industry","conditions":"Diabetes|Diabetes Mellitus, Type 2","interventions":[{"intervention_type":"Drug","name":"Drug: semaglutide","description":"For oral use once daily."},{"intervention_type":"Drug","name":"Drug: placebo","description":"For oral use once daily."}],"outcomes":[{"outcome_type":"primary","measure":"Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE) Composite Endpoint Consisting of: Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke","time_frame":"Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.","description":"Number of participants experiencing a first event of a MACE, defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment."},{"outcome_type":"secondary","measure":"Time From Randomisation to First Occurrence of an Expanded Composite Cardiovascular Endpoint Consisting of: Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, UAP Requiring Hospitalisation or Hospitalisation for Heart Failure","time_frame":"Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.","description":"Participants experiencing first occurrence of an expanded composite CV endpoint [defined as cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, UAP (unstable angina pectoris) requiring hospitalisation or heart failure requiring hospitalisation] are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment."},{"outcome_type":"secondary","measure":"Time From Randomisation to First Occurrence of Each of the Individual Components in the Expanded Composite Cardiovascular Endpoint","time_frame":"Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.","description":"Participants experiencing an event onset for each individual component of the expanded composite cardiovascular outcomes (defined as cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, unstable angina requiring hospitalisation or heart failure requiring hospitalisation) are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment."},{"outcome_type":"secondary","measure":"Time From Randomisation to First Occurrence of a Composite Endpoint Consisting of: All-cause Death, Non-fatal Myocardial Infarction or Nonfatal Stroke","time_frame":"Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.","description":"Participants experiencing first occurrence of a composite CV endpoint (defined as all-cause death, non-fatal myocardial infarction or nonfatal stroke) are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment."},{"outcome_type":"secondary","measure":"Time From Randomisation to First Occurrence of Fatal or Non-fatal Myocardial Infarction","time_frame":"Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.","description":"Number of participants experiencing a first event of a fatal or non-fatal myocardial infarction are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment."},{"outcome_type":"secondary","measure":"Time From Randomisation to First Occurrence of Fatal or Non-fatal Stroke","time_frame":"Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.","description":"Number of participants experiencing a first event of a fatal or non-fatal stroke are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment."},{"outcome_type":"secondary","measure":"Time From Randomisation to All-cause Death","time_frame":"Maximum treatment duration is dependent on event rates and is expected to be no longer than 19 months + 5 weeks of follow-up period.","description":"Number of all-cause deaths in the study are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment."},{"outcome_type":"secondary","measure":"Time to First AE Leading to Permanent Trial Product Discontinuation","time_frame":"Maximum treatment duration is dependent on event rates and is expected to be no longer than 19 months + 38 days of ascertainment window.","description":"Number of participants who permanently discontinued trial product in ths study are presented. Results are based on the on-treatment observation period which starts at the date of first dose on trial product; ends on last date on trial product +38 days (ascertainment window)."},{"outcome_type":"secondary","measure":"Number of Serious Adverse Events","time_frame":"Maximum treatment duration is dependent on event rates and is expected to be no longer than 19 months + 38 days of ascertainment window.","description":"Number of serious adverse events were recorded from week 0 to week 87 in the study. Results are based on the on-treatment observation period which started at the date of first dose on trial product and ended on last date on trial product +38 days (ascertainment window)."},{"outcome_type":"secondary","measure":"Change in Eye Examination Category","time_frame":"Week -3, End of treatment","description":"Participants with eye examination findings, normal, abnormal non clinically significant (NCS) and abnormal clinically significant (CS) at baseline (week -3) and end of treatment visit (week 83) are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment."},{"outcome_type":"secondary","measure":"Change in Pulse Rate","time_frame":"Week 0, End of treatment","description":"Change from baseline (week 0) in pulse rate measured at the end of treatment visit (week 83) is reported. Results are based on the on-treatment observation period which started at the date of first dose on trial product, ended on last date on trial product +38 days (ascertainment window)."},{"outcome_type":"secondary","measure":"Change in Systolic and Diastolic Blood Pressure","time_frame":"Week 0, End of treatment","description":"Change from baseline (week 0) in systolic and diastolic blood pressure measured at the end of treatment visit (week 83) is reported. Results are based on the on-treatment observation period which started at the date of first dose on trial product, ended on last date on trial product +38 days (ascertainment window)."},{"outcome_type":"secondary","measure":"Change in Glycosylated Haemoglobin (HbA1c)","time_frame":"Week 0, End of treatment","description":"Change from baseline (week 0) in HbA1c measured at the end of treatment visit (week 83) is reported. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment."},{"outcome_type":"secondary","measure":"Change in Body Weight","time_frame":"Week 0, End of treatment","description":"Change from baseline (week 0) in body weight measured at the end of treatment visit (week 83) is reported. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment."},{"outcome_type":"secondary","measure":"Change in Total Cholesterol - Ratio to Baseline","time_frame":"Week 0, End of treatment","description":"Change from baseline (week 0) in total cholesterol (mmol/L) at the end of treatment (week 83) visit is presented as ratio to baseline. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment."},{"outcome_type":"secondary","measure":"Change in LDL-cholesterol - Ratio to Baseline","time_frame":"Week 0, End of treatment","description":"Change from baseline (week 0) in LDL cholesterol (mmol/L) at end of treatment visit (week 83) is presented as ratio to baseline. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment."},{"outcome_type":"secondary","measure":"Change in HDL-cholesterol - Ratio to Baseline","time_frame":"Week 0, End of treatment","description":"Change from baseline (week 0) in HDL cholesterol (mmol/L) at end of treatment visit (week 83) is presented as ratio to baseline. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment."},{"outcome_type":"secondary","measure":"Change in Triglycerides - Ratio to Baseline","time_frame":"Week 0, End of treatment","description":"Change from baseline (week 0) in triglycerides (mmol/L) at end of treatment visit (week 83) is presented as ratio to baseline. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment."}]}
{"nct_id":"NCT03212456","start_date":"2017-01-12","phase":"N/A","enrollment":146,"brief_title":"Evaluation of Post-operative Biochemical Recurrence in Patients Submitted to Radical Prostatectomy Under General Opioid-free Anesthesia Compared to Conventional General Anesthesia","official_title":"Evaluation of Post-operative Biochemical Recurrence in Patients Submitted to Radical Prostatectomy Under General Opioid-free Anesthesia Compared to Conventional General Anesthesia","primary_completion_date":"2020-09-30","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2020-12-30","last_update":"2020-07-29","description":"The use of opioids facilitates angiogenesis and has a proven action in the immune system, mainly in the reduction of natural killer cell activity, favoring the migration of neoplastic cells and inhibiting humoral and cellular immunity. These factors may contribute to recurrence and tumor metastasis. Therefore, could opioid-free anesthesia help reduce tumor recurrence? This is a prospective randomized controlled clinical trial in which patients undergoing radical prostatectomy will be evaluated by conventional means, which have moderate and high D'Amico criteria for tumor recurrence. In the operating room, patients will be monitored, receive peripheral venoclysis and then randomized into two groups: in group I, the anesthetic induction will be done with pre oxygenation with 100% O2, propofol, cisatracurium, lidocaine and fentanyl; In group II the induction will be done with the same doses of propofol, cisatracurium, lidocaine and placebo. In both groups maintenance of general anesthesia will be with propofol 1% target infusion controlled with model of Marsh target-controlled infusion plasma between 2.0 and 3.0 mcg / ml, ketamine, lidocaine and dexmedetomidine. Both groups will receive blockade of the transverse plane of the ultrasound guided ultrasound, group I with placebo (saline 0.9% 20 ml on each side) and group II with ropivacaine 0.375% 20 ml on each side. And the postoperative analgesia will be based on anti-inflammatory and opioid analgesics (pca of morphine) according to the analgesic pain scale of the patients. In the postoperative period, patients will be followed up for 2 years with serial doses of prostate specific antigen (PSA) to diagnose tumor recurrence (2 PSA measures> 0.2 ng / ml) and will be evaluated in relation to analgesia, need for analgesia of Rescue with morphine, satisfaction with the anesthetic technique, adverse effects (nausea and vomiting). The primary objective is to evaluate tumor biochemical recurrence after radical prostatectomy in patients undergoing opioid anesthesia compared to patients anesthetized without opioids. The secondary objectives are to evaluate the quality of analgesia with the two techniques, patient satisfaction with perioperative period, quality of anesthetic recovery and adverse effects (nausea and vomiting, pruritus and drowsiness). Thus, to answer the hypothesis raised, 146 patients will be needed (73 in each group).","other_id":"NP 834/15","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"Male","minimum_age":40,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Prostate Cancer;\r\n\r\n          -  Intermediate to high risk of recurrence by D'Amico criteria (Gleason scale > or = 7;\r\n             PSA > or = 10)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patient refuse;\r\n\r\n          -  atrioventricular blockade;\r\n\r\n          -  Coagulopathy;\r\n\r\n          -  Other procedure at same time.\r\n      ","sponsor":"Instituto do Cancer do Estado de So Paulo","sponsor_type":"Other","conditions":"Prostate Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: opioid-free group","description":"We'll study if the opioid-free anesthesia can reduce the biochemical recurrence of prostate cancer."},{"intervention_type":"Drug","name":"Drug: Opioid Group","description":"This group will receive fentanyl in the induction of anesthesia."},{"intervention_type":"Procedure","name":"Procedure: transversus abdominal plane block with ropivacaine","description":"The opioid-free group will receive transversus abdominal plane block with ropivacaine 0,375% 20 ml each side"},{"intervention_type":"Procedure","name":"Procedure: transversus abdominal plane block with placebo","description":"the non-opioid free group will receive transversus abdominal plane block with physiological solution 0,9% 20 ml each side"}],"outcomes":[{"outcome_type":"primary","measure":"Biochemical recurrence of prostate cancer","time_frame":"Up to 2 years after the date of the surgery","description":"It's going to be measured the prostate specific antigen in 4 times after the date of the surgery( 6 months, 1 year, 1 and a half year and 2 years after the surgery) to compare elevations between the two groups."},{"outcome_type":"secondary","measure":"Neutrophil-to-lymphocyte ratio","time_frame":"24 hour postoperatively","description":"Compare the peutrophil-to-lymphocyte ratio preoperatively and with 24 hour postoperatively between the two groups to study about inflammation."},{"outcome_type":"secondary","measure":"visual analogue pain score in the post-anaesthesia care unit","time_frame":"Up to 2 hours postoperatively","description":"Compare the pain scale between the two groups in the delivery of post-anaesthesia care unit"},{"outcome_type":"secondary","measure":"Rescue Morphine","time_frame":"Up to 2 hours postoperatively","description":"compare the total dosis needed for pain at delivery post-anaesthesia care unit"},{"outcome_type":"secondary","measure":"Satisfaction with anesthesia technique","time_frame":"Up to 2 hours postoperatively","description":"compare the satisfaction (a scale from 01 to 10) with anesthesia technique between the two groups at delivery of post-anaesthesia care unit"},{"outcome_type":"secondary","measure":"adverse outcomes","time_frame":"Up to 2 hours postoperatively","description":"compare the postoperative adverse outcomes (such as nausea, pruritus, somnolence) between the two groups at delivery of post-anaesthesia care unit"}]}
{"nct_id":"NCT03010475","start_date":"2017-01-05","phase":"Phase 1","enrollment":41,"brief_title":"A Trial Investigating the Effect of Oral Semaglutide on the Pharmacokinetics of Furosemide and Rosuvastatin in Healthy Subjects","official_title":"A Trial Investigating the Effect of Oral Semaglutide on the Pharmacokinetics of Furosemide and Rosuvastatin in Healthy Subjects.","primary_completion_date":"2017-06-04","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-08-09","last_update":"2017-12-20","description":"This trial is conducted in Europe. Tha aim of this trial is to investigate the effect of oral semaglutide on the pharmacokinetics of furosemide and rosuvastatin in healthy subjects.","other_id":"NN9924-4250","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Informed consent obtained before any trial-related activities. Trial-related\r\n             activities are any procedures that are carried out as part of the trial, including\r\n             activities to determine suitability for the trial\r\n\r\n          -  Male or female, aged 18-65 years (both inclusive) at the time of signing informed\r\n             consent\r\n\r\n          -  Body mass index (BMI) between 20.0-29.9 kg/m^2 (both inclusive)\r\n\r\n          -  Considered to be generally healthy based on the medical history, physical examination,\r\n             and the results of vital signs, electrocardiography and clinical laboratory tests\r\n             performed during the screening visit, as judged by the investigator\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Smoker (defined as a subject who is smoking at least one cigarette or the equivalent\r\n             per day)\r\n\r\n          -  Any blood draw in excess of 25 mL in the past month, or donation of blood or plasma in\r\n             excess of 400 mL within the 3 months preceding screening\r\n\r\n          -  History of major surgical procedures involving the stomach potentially affecting\r\n             absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy,\r\n             gastric bypass surgery)\r\n\r\n          -  Have personal or family history of myopathy\r\n\r\n          -  Previous history of muscular toxicity with another HMG-CoA reductase inhibitor or\r\n             fibrate\r\n\r\n          -  Thyroid-Stimulating Hormone outside lower limit of normal minus 10 percent and upper\r\n             limit of normal plus 10 percent\r\n\r\n          -  Creatine kinase above 5 x upper limit of normal\r\n\r\n          -  Asian subject\r\n      ","sponsor":"Novo Nordisk A/S","sponsor_type":"Industry","conditions":"Diabetes|Healthy","interventions":[{"intervention_type":"Drug","name":"Drug: Furosemide","description":"Oral administration A total of three single doses."},{"intervention_type":"Drug","name":"Drug: Rosuvastatin","description":"Oral administration. A total of three single doses."},{"intervention_type":"Drug","name":"Drug: SNAC","description":"Oral administration. A total of five single doses."},{"intervention_type":"Drug","name":"Drug: Semaglutide","description":"Oral administration. Once daily."}],"outcomes":[{"outcome_type":"primary","measure":"Area under the furosemide plasma concentration-time curve","time_frame":"day 1, day 7, day 54","description":"Based on sampling between 0 and 12 hours"},{"outcome_type":"primary","measure":"Area under the rosuvastatin plasma concentration-time curve","time_frame":"day 2, day 8, day 55","description":"Based on sampling between 0 and 96 hours"},{"outcome_type":"secondary","measure":"Maximum observed furosemide plasma concentration","time_frame":"day 1, day 7, day 54"},{"outcome_type":"secondary","measure":"Maximum observed rosuvastatin plasma concentration","time_frame":"day 2, day 8, day 55"}]}
{"nct_id":"NCT02910882","start_date":"2017-01-03","phase":"Phase 2","enrollment":4,"brief_title":"PEGPH20 Plus Gemcitabine With Radiotherapy in Patients With Localized, Unresectable Pancreatic Cancer","official_title":"A Phase II Study Combining PEGPH20 With Concurrent Gemcitabine and Radiotherapy in Patients With Localized, Unresectable Pancreatic Adenocarcinoma","primary_completion_date":"2018-08-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2018-08-31","last_update":"2019-04-11","description":"This is a single arm phase II trial assessing the potential activity of combination PEGPH20 plus Gemcitabine with radiotherapy in ten patients with localized, unresectable pancreatic adenocarcinoma.","other_id":"PEGPH20-GEM-XRT","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","maximum_age":90,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Subjects must satisfy all the following inclusion criteria to be enrolled in the study:\r\n\r\n          1. Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent\r\n             Form;\r\n\r\n          2. For men and women of reproductive potential, agreement to use an effective\r\n             contraceptive method from the time of screening and throughout their time on study.\r\n             Effective contraceptive methods consist of prior sterilization, intra-uterine device,\r\n             oral or injectable contraceptives, and/or barrier methods. Abstinence alone is not\r\n             considered an adequate contraceptive measure for the purposes of this study;\r\n\r\n          3. Patients with previously untreated localized, unresectable histologically confirmed\r\n             pancreatic adenocarcinoma (unresectable will be defined as locally advanced disease or\r\n             when patients cannot have or refuse surgery);\r\n\r\n          4. Absolute Neutrophil Count (ANC)  1.5 x 109/L;\r\n\r\n          5. Platelets  100 x 109/L;\r\n\r\n          6. Hgb  9 g/dL;\r\n\r\n          7. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT)  2.5 x [Upper\r\n             Limit of Normal (ULN)];\r\n\r\n          8. Bilirubin  1.5 x ULN;\r\n\r\n          9. GFR  30 mL/min;\r\n\r\n         10. Patient has no clinically significant abnormalities in urinalysis results;\r\n\r\n         11. Patient has acceptable coagulation status as indicated by a Prothrombin Time (PT) and\r\n             Partial Thromboplastin Time (PTT) within 15% of normal limits;\r\n\r\n         12. Eastern Cooperative Oncology Group (ECOG)  2\r\n\r\n        Exclusion Criteria:\r\n\r\n        Subjects are ineligible for enrollment if they meet any of the following exclusion\r\n        criteria:\r\n\r\n          1. Clinical evidence of deep vein thrombosis (DVT), pulmonary embolism (PE) or other\r\n             known thromboembolic (TE) event present during the screening period;\r\n\r\n          2. Any prior history of cerebrovascular accident, transient ischemic attack, or\r\n             pre-existing carotid artery disease.\r\n\r\n          3. Known allergy to hyaluronidase;\r\n\r\n          4. Current use of megestrol acetate (use within 10 days of Day 1);\r\n\r\n          5. Contraindication to heparin including prior heparin induced thrombocytopenia (HIT),\r\n             recent CNS bleed; intracranial or spinal lesion at high risk for bleeding; severe\r\n             platelet dysfunction; recent major operation at high risk for bleeding; underlying\r\n             hemorrhagic coagulopathy; high risk for falls; potential need for spinal\r\n             anesthesia/lumbar puncture; active bleeding;\r\n\r\n          6. Women currently pregnant or breastfeeding;\r\n\r\n          7. Intolerance to dexamethasone;\r\n\r\n          8. Inability to comply with study and follow-up procedures as judged by the Investigator;\r\n\r\n          9. Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring\r\n             systemic therapy;\r\n\r\n         10. Patient has known infection with HIV, hepatitis B, or hepatitis C;\r\n\r\n         11. Patient has a history of allergy or hypersensitivity to any of the agents they are\r\n             supposed to receive (or to any of the excipients for those agents);\r\n\r\n         12. Patient has serious medical risk factors involving any of the major organ systems such\r\n             that the investigator considers it unsafe for the patient to receive an experimental\r\n             research drug, these can include New York Heart Association Functional Class  3,\r\n             myocardial infarction within the past 12 months before screening, pre-existing atrial\r\n             fibrillation, symptomatic COPD.\r\n\r\n         13. Patient is unwilling or unable to comply with study procedures.\r\n      ","sponsor":"Scripps Health","sponsor_type":"Other","conditions":"Pancreatic Adenocarcinoma Non-resectable","interventions":[{"intervention_type":"Radiation","name":"Radiation: Radiation","description":"Radiotherapy, beginning Day #2, delivered at 1.8 Gy per fraction, 5 fractions per week (Monday - Friday), until a total dose of 50.4 to 54 Gy for up to 6 Weeks."},{"intervention_type":"Drug","name":"Drug: PEGylated Recombinant Human Hyaluronidase (PEGPH20)","description":"PEGPH20 Dosing (Cohort I, Dose Escalation, First 3 patients): Administered as an IV infusion over 10 minutes (+/- 2 Minutes), approximately 1mL/minute:\r\nDose level 1 - 1 mcg/kg; Dose level 2 - 1.6 mcg/kg; Dose level 3 - 3 mcg/kg.\r\nPEGPH20 Dosing (Cohort II, Patients 4-10): Administered at a dose of 3 mcg/kg as an IV infusion over 10 minutes (+/- 2 Minutes), approximately 1mL/minute.\r\nDosing Schedule: Twice per week beginning Day #1 for 8 doses, then weekly until end of radiotherapy."},{"intervention_type":"Drug","name":"Drug: Gemcitabine","description":"Gemcitabine Dosing: Administered at a dose of 600 mg/m2 as an IV infusion over 30 - 60 minutes with standard antiemetic pre-medication. If administered on PEGPH20 day, Gemcitabine will be infused 2-4 Hours after PEGPH20 infusion is completed.\r\nDosing Schedule: Weekly, beginning Day #2, per standard regimen."}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants with Treatment Related Adverse Events (AEs)","time_frame":"Up to 8 Weeks After the End of Treatment","description":"Adverse events will be assessed weekly, from Day1 Treatment through up to 8 weeks after the end of treatment. Safety will be assessed during the study by evaluation of AEs, clinical safety laboratory tests (hematology, blood chemistry (including C-reactive protein [CRP]), coagulation, urinalysis, and PEGPH20 immunogenicity), vital signs, 12-lead ECGs, and physical examinations.\r\nThe severity of AEs will be graded by Investigators using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03"},{"outcome_type":"secondary","measure":"Overall Tumor Response Rate","time_frame":"Change from Baseline through 8 Weeks After End of Radiation Therapy","description":"CT Chest/Abdomen/Pelvis will be completed at End of Study Visit. End of Study visit will be done 6-8 weeks after the last day of radiotherapy. The evaluation of overall lesion response will be a composite of the target lesion response, non-target lesion response and presence of new lesions, per RECIST 1.1 criteria."},{"outcome_type":"secondary","measure":"Conversion to Resectability Rate","time_frame":"Up to 8 Weeks After End of Radiation Therapy","description":"Number of enrolled subjects completing at least 2 weeks of PEGPH20 plus concurrent gemcitabine and radiotherapy who meet institutional surgical criteria for surgical resectability, as determined by End of Study CT imaging. End of Study CT imaging will be done up to 8 weeks after the end of radiation therapy."},{"outcome_type":"secondary","measure":"Carcinoembryonic Antigen (CEA) Response","time_frame":"Change from Day 1 through 8 Weeks After End of Treatment","description":"Change in CEA serum levels from Day 1 through 8 weeks after end of treatment will be assessed."},{"outcome_type":"secondary","measure":"CA 19-9 Response","time_frame":"Change from Day 1 through 8 Weeks After End of Treatment","description":"Change in CA 19-9 serum levels from Day 1 through 8 weeks after end of treatment will be assessed."},{"outcome_type":"secondary","measure":"Determine the Maximum or Peak Plasma PEGPH20 Concentration (cmax) at End of Infusion","time_frame":"At Specific Timepoints from Day 1 through Day 39 During Treatment","description":"Maximum Plasma PEGPH20 concentration (cmax) will be analyzed in all patients, at the following time points:\r\nDay 1: Pre-Dose; Day 1 Post-Dose @ 1hr, 2hr, 6hr; Day 2 (24Hr Post Dose); Day 3 (48Hr Post Dose); Day 4 (72Hr Post Dose); Day 8: Pre-Dose; Day 9 (24Hr Post Dose); Day 10 (48Hr Post Dose); Day 11 (72 Hr Post Dose); Day 36: Pre-Dose; Day 37 (24 Hr Post Dose); Day 38 (48Hr Post Dose); Day 39 (72 Hr Post Dose);\r\nPharmacokinetic (PK) data will analyzed by non-compartmental analysis (NCA)."},{"outcome_type":"secondary","measure":"Determine Plasma PEGPH20 Area Under the Curve (AUC) After Day 1 PEGPH20 Infusion","time_frame":"At Specific Timepoints from Day 1 through Day 39 During Treatment","description":"Plasma PEGPH20 Area Under the Curve (AUC) will be analyzed in all patients, at the following time points:\r\nDay 1: Pre-Dose; Day 1 Post-Dose @ 1hr, 2hr, 6hr; Day 2 (24Hr Post Dose); Day 3 (48Hr Post Dose); Day 4 (72Hr Post Dose); Day 8: Pre-Dose; Day 9 (24Hr Post Dose); Day 10 (48Hr Post Dose); Day 11 (72 Hr Post Dose); Day 36: Pre-Dose; Day 37 (24 Hr Post Dose); Day 38 (48Hr Post Dose); Day 39 (72 Hr Post Dose);\r\nPharmacokinetic (PK) data will analyzed by non-compartmental analysis (NCA)."},{"outcome_type":"secondary","measure":"Determine the Maximum or Peak Plasma Hyaluronan Concentration (cmax) After First Dose of PEGPH20","time_frame":"At Specific Timepoints from Day 1 through Day 39 During Treatment","description":"Plasma Hyaluronan (HA) will be analyzed in all patients, at the following time points:\r\nDay 1: Pre-Dose; Day 2 (24Hr Post Dose); Day 3 (48Hr Post Dose); Day 4 (72Hr Post Dose); Day 8: Pre-Dose; Day 9 (24Hr Post Dose); Day 10 (48Hr Post Dose); Day 11 (72 Hr Post Dose); Day 36: Pre-Dose; Day 37(24 Hr Post Dose); Day 38(48Hr Post Dose); Day 39 (72 Hr Post Dose);\r\nHyaluronan pharmacodynamic (PD) data will analyzed by non-compartmental analysis (NCA)."},{"outcome_type":"secondary","measure":"Determine Plasma Hyaluronan Area Under Effect Curve (AUEC) After First Dose of PEGPH20","time_frame":"At Specific Timepoints from Day 1 through Day 39 During Treatment","description":"Plasma Hyaluronan (HA) will be analyzed in all patients, at the following time points:\r\nDay 1: Pre-Dose; Day 2 (24Hr Post Dose); Day 3 (48Hr Post Dose); Day 4 (72Hr Post Dose); Day 8: Pre-Dose; Day 9 (24Hr Post Dose); Day 10 (48Hr Post Dose); Day 11 (72 Hr Post Dose); Day 36: Pre-Dose; Day 37(24 Hr Post Dose); Day 38(48Hr Post Dose); Day 39 (72 Hr Post Dose);\r\nHyaluronan pharmacodynamic (PD) data will analyzed by non-compartmental analysis (NCA)."}]}
{"nct_id":"NCT02959580","start_date":"2017-01-01","phase":"Phase 4","enrollment":100,"brief_title":"Medical and Surgical Treatment for Idiopathic Granulomatous Mastitis","official_title":"Evaluation of Topical Steroids and Surgical Treatment for Idiopathic Granulomatous Mastitis","primary_completion_date":"2020-09-01","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2020-09-30","last_update":"2018-12-06","description":"This study evaluates the clinical response rate of topical steroids in the treatment of idiopathic granulomatous mastitis in female adults. Half of the participants will receive topical steroid and the other half will receive local wide surgical excision.","other_id":"PUMCH-breast-mastitis","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Idiopathic Granulomatous Mastitis\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Breast Carcinoma\r\n      ","sponsor":"Peking Union Medical College Hospital","sponsor_type":"Other","conditions":"Granulomatous Mastitis","interventions":[{"intervention_type":"Drug","name":"Drug: Hydrocortisone Butyrate","description":"topical use"},{"intervention_type":"Procedure","name":"Procedure: extended excision","description":"Lesion extended excision with or without a random breast dermo-glandular flap (BDGF)."}],"outcomes":[{"outcome_type":"primary","measure":"clinical response rate","time_frame":"six months","description":"The clinical response is categorized into ''completely healed,'' ''inadequately healed,'' ''stable,'' ''worsened,'' or ''relapsed'' if the lesions had once healed but symptoms returned."},{"outcome_type":"secondary","measure":"granulomatous mastitis recurrence","time_frame":"two years"}]}
{"nct_id":"NCT03503019","start_date":"2017-01-01","enrollment":3000,"brief_title":"Fructosamine as a Predictor of Surgical Outcomes in Total Joint Arthroplasty A Prospective Multi-center Study","official_title":"Fructosamine as a Predictor of Surgical Outcomes in Total Joint Arthroplasty A Prospective Multi-center Study","primary_completion_date":"2018-12-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2018-12-31","last_update":"2018-04-19","description":"A prospective multicenter study including all patients undergoing elective total hip (THA) or knee (TKA) arthroplasty (primary and revision). Patients will be screened for glycemic control using HbA1c levels, fructosamine levels, and blood glucose levels. Blood samples will be obtained at the preadmission testing (PAT) within 30 days of surgery. On postoperative day 1 (POD-1), morning glucose levels will be obtained for all patients as well. Patients will be followed up for 90 days postop. Study aims 1. To examine the association between serum fructosamine levels and the risk for adverse outcomes (mainly PJI) following TJA among patients with and without diabetes. 2. To compare the utility of fructosamine levels to HbA1c in predicting adverse outcomes. 3. To determine the \"best\" threshold of fructosamine to determine adverse outcomes.","other_id":"18JPAR","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"all patients undergoing elective total hip (THA) or knee (TKA) arthroplasty (primary and\r\n        revision).","criteria":"\n        Inclusion Criteria:\r\n\r\n        all patients undergoing elective total hip (THA) or knee (TKA) arthroplasty (primary and\r\n        revision)\r\n\r\n        Exclusion Criteria:\r\n\r\n        None\r\n      ","sponsor":"Rothman Institute Orthopaedics","sponsor_type":"Other","conditions":"Infection","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Prosthetic Joint Infection","time_frame":"within 90 days of surgery"}]}
{"nct_id":"NCT03769987","start_date":"2017-01-01","enrollment":800,"brief_title":"Registry for Advanced Sarcodiosis","official_title":"Registry for Advanced Sarcoidosis","primary_completion_date":"2019-12-31","study_type":"Observational [Patient Registry]","rec_status":"Unknown status","completion_date":"2020-06-30","last_update":"2018-12-10","description":"Registry with evaluation and genetic information of patients with advanced sarcoidosis and matched sarcoidosis","other_id":"REAS","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":15,"maximum_age":100,"population":"Advanced sarcoidosis is defined by the presence of one or more of the following features:\r\n\r\n          1. Advanced pulmonary disease as defined by one or more of the following\r\n\r\n          2. Symptomatic cardiac disease due to sarcoidosis by either MRI or PET scanning and\r\n\r\n          3. Symptomatic neurologic disease\r\n\r\n          4. Patients who have received third line therapy (anti-TNF antibodies, rituximab, or RCI)","criteria":"\n        Inclusion criteria\r\n\r\n          -  Patients with diagnosis of sarcoidosis based on ATS/WASOG criteria 22\r\n\r\n          -  Age  18 years.\r\n\r\n          -  Life expectancy of at least 2 years.\r\n\r\n          -  Pulmonary function tests (spirometry) within one month of entry or willing to under\r\n             pulmonary function testing on the day of study enrollment\r\n\r\n          -  Sarcoidosis as characterized as either advanced or non-advanced (see protocol for\r\n             definition of advanced disease)\r\n\r\n          -  Subjects must be able to understand and be willing to sign the written informed\r\n             consent form. A signed informed consent form must be appropriately obtained prior to\r\n             the conduct of any trial-specific procedure.\r\n\r\n        Exclusion criteria\r\n\r\n          -  Subjects with a medical disorder, condition, or history of such that would impair the\r\n             subject's ability to participate or complete this study in the opinion of the\r\n             investigator\r\n\r\n          -  Inability to comply with the protocol and/or not willing or not available for\r\n             follow-up assessments.\r\n\r\n          -  Any condition which, in the investigator's opinion, makes the subject unsuitable for\r\n             trial participation.\r\n      ","sponsor":"University of Cincinnati","sponsor_type":"Other","conditions":"Sarcoidosis","interventions":[{"intervention_type":"Other","name":"Other: observation","description":"observe patients every 6 months"}],"outcomes":[{"outcome_type":"primary","measure":"Death","time_frame":"2 years","description":"Determine how many people die during follow up"}]}
{"nct_id":"NCT03376958","start_date":"2017-01-01","phase":"Phase 4","enrollment":32,"brief_title":"Apatinib for Relapsed and Refractory Diffuse Large B Cell Lymphoma","official_title":"Apatinib for Relapsed and Refractory Difuse Large B Cell Lymphoma: an Open-label, Single Armed, Exploratory Study","primary_completion_date":"2019-02-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-04-30","last_update":"2019-07-25","description":"The purpose of this study is to evaluate the efficacy and safety of Apatinib for patients with Relapsed Refractory Diffuse Large B Cell Lymphoma.","other_id":"hnslblzlzx2017-1","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":14,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age range 14-70 years old; ECOG performance status 0-2.\r\n\r\n          -  Estimated survival time > 6 months.\r\n\r\n          -  Histological confirmed diffuse large B cell lymphoma.\r\n\r\n          -  Have taken first-line chemotherapy regimen and failed.\r\n\r\n          -  None of chemotherapy contraindication: hemoglobin  90 g/dl, neutrophil  1.5109/L,\r\n             platelet  100109/L, ALT and AST  2ULN, serum bilirubin  1.5ULN, serum creatine \r\n             1.5upper limitation of normal (ULN), Serum Albumin  30g/L, serum plasminogen is\r\n             normal.\r\n\r\n          -  At least one measurable lesion.\r\n\r\n          -  None of other serious diseases, cardiopulmonary function is normal.\r\n\r\n          -  Pregnancy test of women at reproductive age must be negative.\r\n\r\n          -  Patients could be followed up.\r\n\r\n          -  None of other relative treatments including the traditional Chinese medicine,\r\n             immunotherapy, biotherapy except anti-bone metastasis therapy and other symptomatic\r\n             treatments.\r\n\r\n          -  Volunteers who signed informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Disagreement on blood sample collection.\r\n\r\n          -  Patients allergic of any of drug in this regimen or with metabolic disorder.\r\n\r\n          -  Pregnant or lactating women.\r\n\r\n          -  Serious medical illness likely to interfere with participation.\r\n\r\n          -  Serious infection.\r\n\r\n          -  Primitive or secondary tumors of central nervous system.\r\n\r\n          -  Chemotherapy or radiotherapy contraindication.\r\n\r\n          -  The evidence of CNS metastasis.\r\n\r\n          -  History of peripheral nervous disorder or dysphrenia.\r\n\r\n          -  Patients participating in other clinical trials.\r\n\r\n          -  Patients taking other antitumor drugs.\r\n\r\n          -  Patients estimated to be unsuitable by investigator.\r\n      ","sponsor":"Zhengzhou University","sponsor_type":"Other","conditions":"Relapsed and Refractory|Diffuse Large B Cell Lymphoma","interventions":[{"intervention_type":"Drug","name":"Drug: Apatinib","description":"Apatinib, a novel small molecule vascular endothelial growth factor receptor-2 (VEGFR-2) tyrosine kinase inhibitor, have shown remarkable efficacy in many solid cancers. The result of our study presented that apatinib might have a rapid, safe and high efficacy on lymphoma patients."}],"outcomes":[{"outcome_type":"primary","measure":"Overall Response Rate","time_frame":"up to end of follow-up-phase","description":"The proportion of patients whose tumor volume has reduced to a predetermined value and can maintain the minimum time limit is the sum of complete and partial mitigation."},{"outcome_type":"secondary","measure":"Progression-free Survival","time_frame":"up to end of follow-up-phase","description":"The time between the start of randomization and the progression of the tumor (any aspect) or (for any reason) death"},{"outcome_type":"secondary","measure":"Overall Survival","time_frame":"up to the date of death or end of follow-up-phase","description":"Time from randomization to death for any reason"}]}
{"nct_id":"NCT03002662","start_date":"2016-12-31","enrollment":1000,"brief_title":"Cecal Intubation Time in Colonoscopy: Prospective Clinical Trial","primary_completion_date":"2017-09-01","study_type":"Observational","rec_status":"Unknown status","completion_date":"2017-09-15","last_update":"2017-08-29","description":"During colonoscopy, body mass index, waist circumference and waist / hip ratio is the relationship between the cecal intubation difficulty aims to define.","other_id":"2016.5/8-19","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"There are cases of distant referral to the gastroenterology surgeon's polyclinic and\r\n        indications for colonoscopy.","criteria":"\n        Inclusion Criteria:\r\n\r\n        1. Above 18\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Bad bowel preparation\r\n\r\n          2. Failure of cecum intubation\r\n\r\n          3. Inflammatory bowel disease\r\n\r\n          4. Colectomy story\r\n      ","sponsor":"Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital","sponsor_type":"Other","conditions":"Endoscopy|Colonoscopy","interventions":[{"intervention_type":"Other","name":"Other: colonoscopy"}],"outcomes":[{"outcome_type":"primary","measure":"Body mass index (kg/m2)","time_frame":"12/01/2016- 05/01/2017"},{"outcome_type":"primary","measure":"waist circumference (centimeter)","time_frame":"12/01/2016- 05/01/2017"},{"outcome_type":"primary","measure":"waist / hip ratio","time_frame":"12/01/2016- 05/01/2017"}]}
{"nct_id":"NCT03254576","start_date":"2016-12-31","enrollment":132,"brief_title":"Cue-Reward Learning and Weight Gain in Youth","official_title":"Cue-Reward Learning and Weight Gain in Youth","primary_completion_date":"2021-11-30","study_type":"Observational","rec_status":"Recruiting","completion_date":"2023-12-31","last_update":"2021-06-04","description":"The objective of the study is to compare children at low risk for obesity (two healthy weight parents) to children at high risk for obesity (two overweight parents) in their response rate to food taste and in their rate of learning using fMRI.","other_id":"161468","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":8,"maximum_age":11,"population":"Healthy-weight children (30-75thBMI%) between the ages of 8 and 11 years old with either\r\n        two over-weight parents (BMI>25) or two healthy-weight parents (BMI = 18-24.9)","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy weight children between the ages of 8 and 11 Years\r\n\r\n          -  BMI 30-75th percentile\r\n\r\n          -  Child must be right-handed\r\n\r\n          -  Child must be willing to participate in an fMRI scan\r\n\r\n          -  Either two biological parents who are overweight/obese or no biological parents that\r\n             are overweight/obese\r\n\r\n          -  One biological parent willing to bring child to assessment visits\r\n\r\n          -  Child and participating parent Fluent in English for speaking, reading, and writing\r\n\r\n          -  Child must like cheese pizza and chocolate milkshake\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Child overweight (BMI85th percentile)\r\n\r\n          -  Child diagnoses of a serious chronic physical disease (e.g., diabetes) for which\r\n             physician supervision of diet and exercise prescription are needed\r\n\r\n          -  Child who is taking medications that may impact brain responses (can take kids who are\r\n             stable on meds)\r\n\r\n          -  Child with MRI contraindications (presence of metallic foreign object or device in\r\n             body, piercings that cannot be removed, tattooed permanent makeup that contain metal,\r\n             braces, head trauma, claustrophobia, use of Bigen permanent hair dye)\r\n\r\n          -  Child with an active eating disorder (reported on EDE interview) or with first degree\r\n             relative with Anorexia Nervosa or Bulimia Nervosa\r\n\r\n          -  Cognitive impairment or disability determined through parent and child self-report\r\n             measures, and parent reported child individual education plan\r\n\r\n          -  Vision problems uncorrectable with lenses\r\n\r\n          -  Food allergies related to cheese pizza, chocolate milkshake, or the snack foods used\r\n             in the study\r\n\r\n          -  Menarche in female participants at time of enrollment\r\n\r\n          -  Stage 3 or greater on the Tanner developmental stages of puberty\r\n      ","sponsor":"University of California, San Diego","sponsor_type":"Other","conditions":"Overweight|Obesity","interventions":[{"intervention_type":"Other","name":"Other: Functional MRI"}],"outcomes":[{"outcome_type":"primary","measure":"Cue-reward learning","time_frame":"Baseline only","description":"Whether rate of the shift in BOLD response from food cue to neutral cue is different between high and low-risk children"},{"outcome_type":"primary","measure":"Reward Sensitivity","time_frame":"Baseline only","description":"Whether the BOLD response to food cue differs between high and low-risk children"},{"outcome_type":"primary","measure":"Weight gain","time_frame":"Change from baseline at an average of 12 months and 24 months","description":"Whether rate of cue reward and reward sensitivity predict weight gain"}]}
{"nct_id":"NCT02998619","start_date":"2016-12-31","enrollment":52,"brief_title":"Radiotherapy of Pelvic Lymph Nodes in High Risk Prostate Cancer - A Retrospective Analysis","official_title":"Retrospektive Analyse Der Radiotherapie Des Pelvinen Lymphabflusses Beim Lokalisierten Prostatakarzinom Vom Hochrisikotyp Anhand Der Klinikdatenbank 2010-2016","primary_completion_date":"2017-11-11","study_type":"Observational","rec_status":"Completed","completion_date":"2018-06-19","last_update":"2018-07-31","description":"Men with high risk prostate cancer who underwent radiotherapy of the prostate/seminal vesicles or underwent postoperative radiotherapy including pelvic lymph nodes between 2010 and 2016 are analyzed retrospectively. The aims are to estimate progression-free survival as well as toxicity according to CTCAE v4.03.","other_id":"BASEC 2016-01325","observational_model":"Other","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"Male","minimum_age":18,"maximum_age":100,"population":"Retrospective analysis of men irradiated for high risk prostate cancer including pelvic\r\n        lymph nodes (L5/S1)","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Men with high risk prostate cancer treated with radiotherapy to prostate/seminal\r\n             vesicles or postoperative radiotherapy and pelvic lymph nodes at the Kantonssptial\r\n             Graubuenden, Department of Radiation Oncology between 2010 and 2016\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Men with prostate cancer other than high risk disease and no radiotherapy to pelvic\r\n             lymph nodes\r\n      ","sponsor":"Kantonsspital Graubuenden","sponsor_type":"Other","conditions":"Prostatic Neoplasms Benign|Radiotherapy Side Effect|Lymph Node Disease","interventions":[{"intervention_type":"Radiation","name":"Radiation: Radiotherapy","description":"Radiation to prostate/seminal vesicles including pelvic lymph nodes Postoperative radiation to prostate bed including pelvic lymph nodes"}],"outcomes":[{"outcome_type":"primary","measure":"Progression-free survival","time_frame":"through study completion, an average of 2 years","description":"PSA progession-free survival will be measured"},{"outcome_type":"secondary","measure":"Toxicity (CTCAE v4.03)","time_frame":"through study completion, an average of 2 years","description":"GI, GU Toxicities as well as Erectile Dysfunction will be measured"}]}
{"nct_id":"NCT02950636","start_date":"2016-12-31","phase":"N/A","enrollment":3,"brief_title":"Effect of Yoga on Mood and Quality of Life in Patients With Refractory Epilepsy","official_title":"Effect of Yoga on Mood and Quality of Life in Patients With Refractory Epilepsy","primary_completion_date":"2017-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-10-04","last_update":"2018-04-30","description":"The purpose of this study is to learn if a structured yoga program can reduce anxiety, improve depression, and improve quality of life in patients with medication resistant epilepsy (MRE).","other_id":"STUDY00140045","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosis of unilateral or bilateral temporal lobe epilepsy\r\n\r\n          -  Presence 3 or more seizures per month\r\n\r\n          -  No medical contraindications to yoga\r\n\r\n          -  Willing and able to perform simple non strenuous yoga exercises\r\n\r\n          -  Ability to get on the floor and up again without assistance\r\n\r\n          -  Ambulatory\r\n\r\n          -  Ability to travel to the yoga class twice a week\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any yoga in the last 6 months\r\n\r\n          -  Inability to perform yoga exercises\r\n\r\n          -  History of epilepsy surgery within the last year\r\n\r\n          -  Currently pregnant or less than 6 week postpartum\r\n      ","sponsor":"University of Kansas Medical Center","sponsor_type":"Other","conditions":"Depression|Anxiety","interventions":[{"intervention_type":"Other","name":"Other: Yoga","description":"Restorative Yoga"}],"outcomes":[{"outcome_type":"primary","measure":"Change in Neurological Disorders Depression Inventory for Epilepsy (NDDI-E)","time_frame":"Change from Week 4 to Week 12","description":"The NDDI-E is a 6 item questionnaire. Scores for each question range from 1 (never) to 4 (all the time). There is a maximum score of 24. The higher the score the more severe the depression."},{"outcome_type":"secondary","measure":"Change in Generalized Anxiety Disorder 7-item (GAD-7) scale","time_frame":"Change from Week 4 to Week 12","description":"The GAD-7 is a 7 item questionnaire. Scores for each question range from 0 (not at all) to 3 (nearly every day). There is a maximum score of 21. The higher the score the more severe the anxiety. A score over 15 represents severe anxiety. A score under 10 may indicate GAD and would prompt further examination."},{"outcome_type":"secondary","measure":"Change in Quality of Life in Epilepsy-Patient-Weighted (QOLIE-31-p)","time_frame":"Change from Baseline to Week 12","description":"The QOLIE-31-p is a 38 item questionnaire. Scores range from 0-100. Higher scores relate to higher distress."},{"outcome_type":"secondary","measure":"Frequency of seizures","time_frame":"Week 12","description":"Count of seizures in study subjects"}]}
{"nct_id":"NCT02995941","start_date":"2016-12-31","enrollment":138,"brief_title":"Shoulder Symptom Irritability Scale: A Single-Blinded Observational Study","official_title":"Shoulder Symptom Irritability: A Single-Blinded Observational Study of Reliability and Construct Validity","primary_completion_date":"2017-07-31","study_type":"Observational","rec_status":"Completed","completion_date":"2017-07-31","last_update":"2019-09-20","description":"The purpose of this study is to examine the reliability and use of the shoulder symptom irritability classification system for the purposes of determining an appropriate treatment intensity to better help people with shoulder pain.","other_id":"2016-61","observational_model":"Cohort","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Raters will be recruited from outpatient physical therapists in the St. Luke's University\r\n        Health Network.\r\n\r\n        Patient subjects will be recruited from a convenience sample of consecutive patients\r\n        presenting for physical therapy consultation for shoulder pain.","criteria":"\n        Rater Group\r\n\r\n        Inclusion Criteria:\r\n\r\n          -  State licensure as a physical therapist and regular clinical practice with patients\r\n             with shoulder disorders, defined as a minimum of 500 clinical hours per year in an\r\n             orthopaedic setting with >10% of patients with shoulder disorders\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  not meeting inclusion criteria\r\n\r\n        Patient Group\r\n\r\n        Inclusion Criteria:\r\n\r\n          -  Presenting with a chief complaint of shoulder pain, not extending to the neck, for\r\n             outpatient physical therapy consultation\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Illiteracy in English and age less than 18 years. Additionally, subjects will be\r\n             excluded from the study if they present with pain or symptoms distal to elbow, have\r\n             had shoulder surgery on the symptomatic side in the past year, if active or passive\r\n             cervical spine ROM reproduces shoulder pain, have a positive Spurling's test, or if\r\n             they are unable to complete the patient reported functional questionnaires\r\n      ","sponsor":"St. Luke's Hospital and Health Network, Pennsylvania","sponsor_type":"Other","conditions":"Shoulder Pain|Pain","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Reliability of Shoulder Symptom Irritability Scale","time_frame":"Day 1 of data collection for each subject","description":"Two different raters will individually rate the shoulder symptom irritability of each patient. Raters will be blinded to the other's rating."},{"outcome_type":"secondary","measure":"Focus On Therapeutic Outcomes (FOTO) Functional Score","time_frame":"Day 1 of data collection for each subject","description":"The FOTO functional scale for shoulder disorders27 has a standard error of the mean (SEM) of 1. with a minimal detectable change with 95% confidence (MDC95) of 3.60-10.88 functional score units."},{"outcome_type":"secondary","measure":"Penn Shoulder Score (PSS)","time_frame":"Day 1 of data collection for each subject","description":"The Penn Shoulder Score (PSS)has demonstrated good test-retest reliability (ICC2,1 = 0.94) with a SEM90 of 8.5. The MDC90 is 12.1, and the minimal clinically important difference (MCID) was found to be 11.4."},{"outcome_type":"secondary","measure":"American Shoulder and Elbow Surgeons (ASES) Shoulder Score","time_frame":"Day 1 of data collection for each subject","description":"The ASES Shoulder Score has demonstrated good to excellent test-retest reliability (ICC = 0.61-0.96) with an SEM of 6.7. The MDC95 is 11.2,32 and the MCID was found to be 12.0."},{"outcome_type":"secondary","measure":"Numeric Pain Rating scale","time_frame":"Day 1 of data collection for each subject","description":"The Numeric Pain Rating Scale (NPRS) has demonstrated good reliability (ICC2,1=0.74)and responsiveness (MDC = 2.5, MCID = 1.1) in subjects with shoulder pain34 and excellent reliability in an upper extremity orthopaedic population."},{"outcome_type":"secondary","measure":"Intervention intensity","time_frame":"Day 1 of data collection for each subject","description":"This project will analyze intervention choices from the primary raters for each of the 90 subjects utilizing PABAK-OS for correlation and independent t-test for group differences. It is expected that those subjects with high irritability will be prescribed interventions aimed at minimizing the physical stress to the affected tissue(s), while those subjects with low irritability will be prescribed interventions at a higher intensity to address the physical impairments."}]}
{"nct_id":"NCT01627795","start_date":"2016-12-31","phase":"Phase 1/Phase 2","enrollment":17,"brief_title":"Safety and Efficacy of Oshadi D and Oshadi R for Malignant Mesothelioma Treatment","official_title":"A Single-center, Open Label Study for Evaluation of the Safety and Efficacy of Oshadi D and Oshadi R for Malignant Mesothelioma Treatment - A Phase IIa Study","primary_completion_date":"2018-08-31","study_type":"Interventional","rec_status":"Suspended","completion_date":"2018-12-31","last_update":"2018-04-18","description":"Malignant mesothelioma is a rare neoplasm that arises most commonly from the mesothelial surfaces of the pleural cavity, occasionally from the peritoneal surface, and rarely from the tunica vaginalis or pericardium. It has an extremely poor prognosis with a median survival of 4 to 13 months for untreated patients 1 and 6 to 18 months for treated patients, regardless of the therapeutic approach. The anticancer activity of Oshadi D and Oshadi R treatment was tested in preclinical studies and in phase I clinical study. Four metastatic mesothelioma patients are treated for 5 to 12 months. The Oshadi D and Oshadi R combination treatment was generally well-tolerated with no dose-limiting toxicities observed.","other_id":"OS-MES-P2-01","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":21,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically or cytologically proven diagnosis of malignant mesothelioma\r\n\r\n          -  Man or woman 21 years and above\r\n\r\n          -  Adequate performance status (ECOG 0, 1, or 2)\r\n\r\n          -  Patient must have adequate organ function as the following:\r\n\r\n               -  Absolute neutrophils counts (ANS) > 2500/L.\r\n\r\n               -  Platelets > 150,000/L.\r\n\r\n               -  Hemoglobin > 10 g/dL.\r\n\r\n               -  Total Bilirubin < 1.5 Upper Normal Limit (UNL).\r\n\r\n               -  Alanine aminotransferase (ALT), AST (aspartate aminotransferase)and alkaline\r\n                  phosphatase must be < 1.5 times of the upper limit of normal.\r\n\r\n               -  LDH (lactate dehydrogenase) < 500 int. unit/L\r\n\r\n               -  Estimated GFR (glomerular filtration rate) > 45 ml/min.\r\n\r\n          -  Written informed consent\r\n\r\n          -  Females of childbearing potential and males must be willing to use an effective method\r\n             of contraception (hormonal or barrier method of birth control; abstinence) from the\r\n             time consent is signed until 6 weeks after treatment discontinuation.\r\n\r\n          -  Females of childbearing potential must have a negative pregnancy test within 7 days\r\n             prior to being registered for protocol therapy.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Evidence of liver metastasis\r\n\r\n          -  Any bone involvement\r\n\r\n          -  Prior radiotherapy, cytotoxic or biologic systemic treatment\r\n\r\n          -  Any history of Asthma or COPD (chronic obstructive pulmonary disease) that needs\r\n             systemic therapy with steroids for more than 2 weeks during the last 2 years.\r\n\r\n          -  Treatment with systemic steroids for more then 1 month during the last year.\r\n\r\n          -  Active smokers that are unable to quite smoking\r\n\r\n          -  Any treatment with investigational agent within 30 days prior to registration for\r\n             protocol therapy.\r\n\r\n          -  Cerebrovascular accident, transient ischemic attack or myocardial infarction within 6\r\n             months prior to registration for protocol therapy.\r\n\r\n          -  Evidence of pulmonary embolism within 6 months prior to registration for protocol\r\n             therapy.\r\n\r\n          -  Any history of solid or hematologic malignancies.\r\n\r\n          -  Patient with positive HIV serology at screening.\r\n\r\n          -  Female patient who are breastfeeding or have a positive pregnancy test at screening or\r\n             at any time during the study.\r\n\r\n          -  Uncontrolled hypertension (> 150/100 mm Hg despite optimal medical therapy).\r\n\r\n          -  Evidence of ongoing cardiac dysrhythmias of NCI CTCAE (Common Toxicity Criteria for\r\n             Adverse Effects) Version 3.0 grade 2.\r\n\r\n          -  Patients in whom radiation or surgery is indicated\r\n\r\n          -  Significant swallowing disorders.\r\n\r\n          -  Small bowel surgery.\r\n\r\n          -  Suspicion of absorption disruption as a result of abdominal radiation\r\n\r\n          -  Pre-existing malabsorption syndrome, irritable bowel syndrome or other clinical\r\n             situation which could affect oral absorption.\r\n\r\n          -  Evidence of concurrent (< 5 years) second malignancy\r\n\r\n          -  Mental disorders.\r\n\r\n          -  Inability to give written informed consent.\r\n      ","sponsor":"Oshadi Drug Administration","sponsor_type":"Industry","conditions":"Mesothelioma","interventions":[{"intervention_type":"Drug","name":"Drug: Oshadi D and Oshadi R","description":"anti cancer agents"}],"outcomes":[{"outcome_type":"primary","measure":"Adverse events and serious adverse events occurence","time_frame":"One month following treatment initiation","description":"Adverse events and serious adverse events report"},{"outcome_type":"secondary","measure":"overall survival time","time_frame":"12 months","description":"Overall survival time from treatment initiation"}]}
{"nct_id":"NCT02998515","start_date":"2016-12-31","phase":"N/A","enrollment":30,"brief_title":"Effects of Different Oxygen Devices in Hypoxemic COPD Patients","official_title":"Effects of Supplemental Oxygen Delivery Via Portable Oxygen Concentrator (Activox4L) vs. Liquid Oxygen Device in Hypoxemic COPD Patients - a Non-inferiority Study","primary_completion_date":"2017-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-03-31","last_update":"2017-08-21","description":"Taken recent literature together, there is a sufficient number of trials investigating the effect of different oxygen devices. However, studies comparing oxygen delivery via portable oxygen concentrator (POC) and liquid oxygen device (LOD) with appropriate exercise testing and sufficient power are missing. Given that walking is the most important activity of daily life to preserve the maintenance and to participate in social life, we aim to investigate the effects of two different oxygen delivery systems during walking in hypoxemic COPD patients (POC vs. LOD). The endurance shuttle walk test (ESWT) is well validated for measuring endurance walking capacity in COPD patients with good repeatability. The advantage of this test over the 6MWT is that the ESWT is performed at 85% of the individual maximum which is close to the intensity of typical daily activities. Due to the fact that the ESWT enables us to determine the maximum duration of exercise and to compare values at isotime (at the point of time when the shortest of the 3 ESWTs ends), we use the ESWT as exercise test in our trial.","other_id":"ACT2016","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  COPD patients (GOLD stage III to IV) with hypoxemia at rest or during exercise\r\n             (paO2<60mmHg)\r\n\r\n          -  Participation in an inpatient pulmonary rehabilitation program (Schn Klinik BGL)\r\n\r\n          -  Written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  General exclusion criteria for exercise tests, e.g. acute coronary syndrome, acute\r\n             myo- or pericarditis, acute lung embolism, pulmonary infarction, acute uncontrolled\r\n             heart insufficiency\r\n\r\n          -  Signs of acute exacerbation\r\n\r\n          -  Any orthopedic or neurological disabilities that prevent patient from walking\r\n      ","sponsor":"Schn Klinik Berchtesgadener Land","sponsor_type":"Other","conditions":"Chronic Obstructive Pulmonary Disease Severe","interventions":[{"intervention_type":"Device","name":"Device: Companion (Liquid oxygen device)"},{"intervention_type":"Device","name":"Device: Activox (concentrator)"}],"outcomes":[{"outcome_type":"primary","measure":"Change in oxygen Saturation during endurance shuttle walk test (ESWT) compared between POC (concentrator) and LOD (liquid oxygen)","time_frame":"Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes)","description":"ESWT is designed to assess the Maximum Walking Duration that can be sustained at 85% of individual Maximum capacity. Therefore, outcome Parameter will also be assessed at the individual end of the ESWT."},{"outcome_type":"secondary","measure":"Change in Breathing frequency","time_frame":"Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes)","description":"ESWT is designed to assess the Maximum Walking Duration that can be sustained at 85% of individual Maximum capacity. Therefore, outcome Parameter will also be assessed at the individual end of the ESWT."},{"outcome_type":"secondary","measure":"Change in Inspiratory capacity","time_frame":"Change from baseline to the individual end of ESWT(until exhaustion, max. 20 minutes)","description":"ESWT is designed to assess the Maximum Walking Duration that can be sustained at 85% of individual Maximum capacity. Therefore, outcome Parameter will also be assessed at the individual end of the ESWT.\r\nInspiratory capacity will be measured by a mobile spirometry (SpiroPalm mask)."},{"outcome_type":"secondary","measure":"Endurance shuttle walk distance","time_frame":"at the end of ESWT (until exhaustion, max. 20 minutes)","description":"ESWT is designed to assess the Maximum Walking Duration that can be sustained at 85% of individual Maximum capacity."},{"outcome_type":"secondary","measure":"Change in perceived Dyspnea","time_frame":"Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes)","description":"ESWT is designed to assess the Maximum Walking Duration that can be sustained at 85% of individual Maximum capacity. Therefore, outcome Parameter will also be assessed at the individual end of the ESWT. Dyspnea will be rated by the Patient on a 10-point Borg scale."},{"outcome_type":"secondary","measure":"Change in partial pressure of carbon dioxide","time_frame":"Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes)","description":"ESWT is designed to assess the Maximum Walking Duration that can be sustained at 85% of individual Maximum capacity. Therefore, outcome Parameter will also be assessed at the individual end of the ESWT."}]}
{"nct_id":"NCT03049358","start_date":"2016-12-31","phase":"N/A","enrollment":15,"brief_title":"Olfactory Training in Improving Sense of Smell After Radiation Therapy in Patients With Paranasal Sinus or Nasopharyngeal Cancer","official_title":"Olfactory Training For Post Radiation Olfactory Loss In Patients With Paranasal Sinus and Nasopharyngeal Carcinoma","primary_completion_date":"2018-10-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2018-10-31","last_update":"2019-02-05","description":"This randomized phase I trial studies how well olfactory training works in improving sense of smell after radiation therapy in patients with paranasal sinus or nasopharyngeal cancer. Olfactory training may improve smell function after radiation therapy in patients with paranasal sinus or nasopharyngeal cancer.","other_id":"ENT0059","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":19,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Eligible disease(s)/stage(s): nasopharyngeal carcinoma, paranasal sinus cancers/any\r\n             stage\r\n\r\n          -  Patients with paranasal sinus or nasopharyngeal carcinoma who are about to undergo\r\n             radiation therapy; patients with paranasal sinus or nasopharyngeal carcinoma who have\r\n             completed radiation therapy 3-6 months prior to enrollment who then show olfactory\r\n             loss on a screening test (University of Pennsylvania Smell Identification Test [UPSIT]\r\n             - score of 34 or 33 or lower out of 40, depending on female/male); both those patients\r\n             undergoing chemotherapy and those who did not will be eligible, and this factor will\r\n             be assessed as a possible confounder/contributor in a multi-regression analysis\r\n\r\n          -  No race-ethnic restriction\r\n\r\n          -  No life expectancy restriction\r\n\r\n          -  No need for Karnofsky performance status\r\n\r\n          -  Only requirement for organ function is for patients to have competency to consent and\r\n             participate in the study; in the arm of the study which requires patients to have\r\n             olfactory dysfunction before enrollment, an UPSIT score will be used to identify these\r\n             patients\r\n\r\n          -  Ability to understand and the willingness to sign a written informed consent document\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  No therapy restrictions\r\n\r\n          -  No restrictions on use of other investigational agents\r\n\r\n          -  Co-morbid disease or incurrent illness such as:\r\n\r\n               -  History of head trauma\r\n\r\n               -  History of nasal surgery other than biopsy (before cancer was diagnosed)\r\n\r\n               -  History of sinus surgery other than biopsy (before cancer was diagnosed)\r\n\r\n               -  Chronic rhinosinusitis with or without polyp\r\n\r\n               -  Pregnancy\r\n\r\n               -  Cognitive dysfunction\r\n\r\n               -  History of brain surgery\r\n\r\n               -  Psychiatric or neurologic diseases interfering with sense of smell\r\n\r\n               -  Congenital disorders of olfactory dysfunction\r\n\r\n               -  Olfactory loss prior to onset of nasopharyngeal carcinoma\r\n\r\n          -  No allergic reactivity has been associated with olfactory training and thus there is\r\n             no need for any exclusion criteria related to this\r\n\r\n          -  No other agents have any possible potentiation or decreased activity related to\r\n             olfactory training and thus there is no need for any exclusion criteria related to\r\n             this\r\n\r\n          -  There are no other agent-specific exclusion criteria\r\n\r\n          -  Pregnant women will be excluded; nursing patients will be included\r\n      ","sponsor":"Stanford University","sponsor_type":"Other","conditions":"Stage III Paranasal Sinus Cancer|Stage 0 Nasopharyngeal Carcinoma|Stage 0 Paranasal Sinus Cancer|Stage I Nasopharyngeal Carcinoma|Stage I Paranasal Sinus Cancer|Stage II Nasopharyngeal Carcinoma|Stage II Paranasal Sinus Cancer|Stage IIA Nasopharyngeal Carcinoma|Stage IIB Nasopharyngeal Carcinoma|Stage III Nasopharyngeal Carcinoma|Stage IV Nasopharyngeal Carcinoma|Stage IV Paranasal Sinus Cancer|Stage IVA Nasopharyngeal Carcinoma|Stage IVA Paranasal Sinus Cancer|Stage IVB Nasopharyngeal Carcinoma|Stage IVB Paranasal Sinus Cancer|Stage IVC Nasopharyngeal Carcinoma|Stage IVC Paranasal Sinus Cancer","interventions":[{"intervention_type":"Other","name":"Other: canola oil placebo","description":"patient smells canola oil in vial"},{"intervention_type":"Other","name":"Other: Physiologic Testing","description":"Undergo UPSIT smell test"},{"intervention_type":"Other","name":"Other: Quality-of-Life Assessment","description":"Ancillary studies"},{"intervention_type":"Procedure","name":"Procedure: Sham Intervention","description":"Undergo sham training"},{"intervention_type":"Procedure","name":"Procedure: Therapeutic Procedure","description":"Undergo olfactory training"},{"intervention_type":"Other","name":"Other: rose essential oil","description":"patient smells rose oil in vial"},{"intervention_type":"Other","name":"Other: lemon essential oil","description":"patient smells lemon oil in vial"},{"intervention_type":"Other","name":"Other: clove essential oil","description":"patient smells clove oil in vial"},{"intervention_type":"Other","name":"Other: eucalyptus essential oil","description":"patient smells eucalyptus oil in vial"}],"outcomes":[{"outcome_type":"primary","measure":"Change in olfactory function in patients with paranasal sinus or nasopharyngeal carcinoma after completion of radiation therapy as measured by UPSIT score","time_frame":"Baseline to 12 weeks","description":"T-test or Mann-Whitney U test, where appropriate, will be used for comparing continuous variables, and chi-squared test will be used for comparing categorical variables. Continuous UPSIT score will be summarized using the following statistics: number of subjects, arithmetic mean, standard deviation, median, first quartile, third quartile, minimum, and maximum values. The dependent variable UPSIT score will be either the percent change from baseline or change from baseline in the endpoint. Mixed model repeated measures (MMRM) analysis will be used and the model will included fixed effect terms"},{"outcome_type":"secondary","measure":"Efficacy of olfactory training during radiation therapy as measured by change in UPSIT scores","time_frame":"Baseline","description":"T-test or Mann-Whitney U test, where appropriate, will be used for comparing continuous variables, and chi-squared test will be used for comparing categorical variables. Continuous UPSIT score will be summarized using the following statistics: number of subjects, arithmetic mean, standard deviation, median, first quartile, third quartile, minimum, and maximum values. The dependent variable UPSIT score will be either the percent change from baseline or change from baseline in the endpoint. Mixed model repeated measures (MMRM) analysis will be used and the model will included fixed effect terms"},{"outcome_type":"secondary","measure":"Improvement in quality of life related to olfactory dysfunction as measured by change in the Questionnaire of Olfactory Disorders (QOD) score","time_frame":"Baseline to 12 weeks","description":"Within each subgroup of participants, change in QOD score after olfactory training will be calculated and compared between treatment and control group. Confidence interval (CI) 95% and P value < 5% will be set as statistical parameters to define if noted difference is significant. Based on previous studies, a change of >= 1/2 standard deviation of the pre-treatment score would be clinically significant."},{"outcome_type":"secondary","measure":"Severity of olfactory dysfunction after completion of radiation therapy as measured by UPSIT score","time_frame":"Baseline","description":"T-test or Mann-Whitney U test, where appropriate, will be used for comparing continuous variables, and chi-squared test will be used for comparing categorical variables. Continuous UPSIT score will be summarized using the following statistics: number of subjects, arithmetic mean, standard deviation, median, first quartile, third quartile, minimum, and maximum values. Continuous UPSIT score will be summarized using the following statistics: number of subjects, arithmetic mean, standard deviation, median, first quartile, third quartile, minimum, and maximum values. These statistics will be shown"}]}
{"nct_id":"NCT02996682","start_date":"2016-12-26","phase":"Phase 3","enrollment":102,"brief_title":"Efficacy and Safety of Sofosbuvir/Velpatasvir  Ribavirin for 12 Weeks in Adults With Chronic HCV Infection and Decompensated Cirrhosis","official_title":"A Multicenter, Randomized, Phase 3, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir  Ribavirin for 12 Weeks in Subjects With Chronic HCV Infection and Decompensated Cirrhosis","primary_completion_date":"2018-02-13","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-05-08","last_update":"2019-02-26","description":"The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) with or without ribavirin (RBV) for 12 weeks in adults with chronic hepatitis C virus (HCV) infection and decompensated cirrhosis.","other_id":"GS-US-342-4019","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"population":"","criteria":"\n        Key Inclusion Criteria:\r\n\r\n          -  Chronic HCV-infected males and non-pregnant/non-lactating females\r\n\r\n          -  Treatment naive or treatment experienced individuals\r\n\r\n          -  Child-Pugh-Turcotte Score 7-12 at screening\r\n\r\n        Note: Other protocol defined Inclusion/Exclusion criteria may apply.\r\n      ","sponsor":"Gilead Sciences","sponsor_type":"Industry","conditions":"Hepatitis C Virus Infection","interventions":[{"intervention_type":"Drug","name":"Drug: SOF/VEL","description":"400/100 mg FDC tablet administered orally once daily"},{"intervention_type":"Drug","name":"Drug: RBV","description":"Capsules administered orally in a divided daily dose"}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)","time_frame":"Posttreatment Week 12","description":"SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment."},{"outcome_type":"primary","measure":"Percentage of Participants Who Discontinued Treatment (SOF/VEL or RBV) Early Due to an Adverse Event","time_frame":"Up to 12 weeks"},{"outcome_type":"secondary","measure":"Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)","time_frame":"Posttreatment Week 4","description":"SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment."},{"outcome_type":"secondary","measure":"Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)","time_frame":"Posttreatment Week 24","description":"SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment."},{"outcome_type":"secondary","measure":"Percentage of Participants Who Had HCV RNA < LLOQ by Visit While on Treatment","time_frame":"Up to 12 weeks"},{"outcome_type":"secondary","measure":"Change From Baseline in HCV RNA","time_frame":"Baseline and up to 12 weeks"},{"outcome_type":"secondary","measure":"Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score","time_frame":"Baseline to Posttreatment Week 24","description":"MELD score is a chronic liver disease severity scoring system. Scores can range from 6 to 40, with higher scores indicating greater disease severity. \"No change\" was assigned for differences (posttreatment visits minus baseline score) of -1, 0 or 1; \"Decrease\" was assigned for differences that were less than or equal to -2; and \"Increase\" was assigned for values that were greater than or equal to 2."},{"outcome_type":"secondary","measure":"Percentage of Participants With Improved and Worsened Child-Pugh-Turcotte (CPT) Class","time_frame":"Baseline to Posttreatment Week 24","description":"CPT is a chronic liver disease classification system. Classes include CPT Class A, CPT Class B, and CPT Class C, in order of greater disease severity. Participants with improved CPT class was defined as having Class C at Baseline and Class B or A at Posttreatment Week 24 or Class B at Baseline and Class A at Posttreatment Week 24. Participants with worsened CPT class was defined as having Class A at Baseline and Class B or C at Posttreatment Week 24 or Class B at Baseline and Class C at Posttreatment Week 24. CPT scores were calculated using prothrombin activation percentage for the coagulation parameter per Japan's standard."},{"outcome_type":"secondary","measure":"Percentage of Participants With Virologic Failure","time_frame":"Up to Posttreatment Week 24","description":"Virologic failure was defined as:\r\nBreakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment), or Relapse (HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement)."}]}
{"nct_id":"NCT03821805","start_date":"2016-12-22","phase":"N/A","enrollment":28,"brief_title":"Acute Effect of Foot Reflexology Massage on Heart Rate Variability and Arterial Pulse Waveform","official_title":"Effects of Foot Reflexology Massage on Heart Rate Variability and Arterial Pulse Waveform After Yo Yo Intermittent Recovery Test and Repeated Sprint Test","primary_completion_date":"2017-06-13","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-06-13","last_update":"2019-01-30","description":"Foot reflexology treatment provides acute and chronic effects on cardiovascular and hemodynamic functions. However, no information is available to us in regarding the treatment effect of foot reflexology after exercise. This study investigated the acute effect of foot reflexology treatment on heart rate variability after anaerobic-based and aerobic-based intermittent exercises.","other_id":"UT-IRB-2016-017","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":30,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Undertake football/futsal training at least 3 times a week\r\n\r\n          -  Age between 18 and 30 years old\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of severe neuromuscular injury\r\n\r\n          -  Current lower extremity injury\r\n\r\n          -  Current neurological diseases\r\n      ","sponsor":"University of Taipei","sponsor_type":"Other","conditions":"Massage|Anaerobic Exercise|Aerobic Exercise","interventions":[{"intervention_type":"Other","name":"Other: Foot reflexology massage","description":"Foot reflexology technique of Father Josef was used as massage intervention"}],"outcomes":[{"outcome_type":"primary","measure":"Heart rate variability","time_frame":"immediately following intervention phase","description":"15 minutes resting electrocardiographic record at baseline and post-intervention phase"},{"outcome_type":"secondary","measure":"Arterial pulse waveform","time_frame":"immediately following intervention phase","description":"15 minutes resting arterial plethysmographic waveform at baseline and post-intervention phase"}]}
{"nct_id":"NCT03299153","start_date":"2016-12-21","phase":"Phase 4","enrollment":46,"brief_title":"The Effects of Barberry Juice Consumption in Patients With Type 2 Diabetes","official_title":"The Effects of Barberry Juice Consumption on Glycaemic Control, Lipid Profile, Blood Pressure and Oxidative Stress in Patients With Type 2 Diabetes: A Randomized Clinical Trial","primary_completion_date":"2017-04-16","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-08-05","last_update":"2017-10-02","description":"The aim of this study was to investigate the effect of barberry juice (BJ) as a natural antioxidant, on cardiovascular risk factors in patients with type 2 diabetes (T2DM). In a randomized clinical trial study, 46 T2DM patients, 30-70 years old recruited from \"Diabetes Association of Iran-Babul \". Patients were randomly allocated to either the BJ group (n=23) who consumed 200 ml of BJ daily for eight weeks, or the control group (n=23) with no intervention. At the baseline and the end of 8-week intervention, blood pressure and biochemical markers were conducted.","other_id":"1534","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":30,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Fasting blood glucose>100 mg/dL (5.6 mmol /L)\r\n\r\n          -  Systolic blood pressure>130 mmHg or diastolic blood pressure>85mmHg\r\n\r\n          -  Triglycerides> 150 mg/dL (1.7 mmol/L)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  taking insulin\r\n\r\n          -  smoking\r\n\r\n          -  using antioxidant supplements\r\n      ","sponsor":"National Nutrition and Food Technology Institute","sponsor_type":"Other","conditions":"Type 2 Diabetes","interventions":[{"intervention_type":"Other","name":"Other: barberry juice"}],"outcomes":[{"outcome_type":"secondary","measure":"LDL- cholesterol","time_frame":"8 weeks"},{"outcome_type":"secondary","measure":"HDL- cholesterol","time_frame":"8 weeks"},{"outcome_type":"secondary","measure":"Triglyceride","time_frame":"8 weeks"},{"outcome_type":"secondary","measure":"HbA1c","time_frame":"8 weeks"},{"outcome_type":"secondary","measure":"Systolic BP","time_frame":"8 weeks"},{"outcome_type":"secondary","measure":"Diastolic BP","time_frame":"8 weeks"},{"outcome_type":"primary","measure":"fasting blood glucose","time_frame":"8 weeks"},{"outcome_type":"primary","measure":"total cholesterol","time_frame":"8 weeks"}]}
{"nct_id":"NCT03297073","start_date":"2016-12-20","phase":"N/A","enrollment":80,"brief_title":"Paracetamol Metabolism Research in Postoperative Hepatic Surgery","official_title":"Paracetamol Metabolism Research in Postoperative Hepatic Surgery","primary_completion_date":"2020-01-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2020-01-31","last_update":"2019-10-11","description":"The main objective of this study was to evaluate the 5-day kinetics of plasma paracetamol levels in postoperative major hepatic surgery (resection greater than or equal to three hepatic segments) compared with less extensive liver resection and hepatic re-intervention. The clearance of indocyanine green is a marker of hepatic perfusion but also of the proper hepatocyte functioning, if hemodynamic conditions are stable. Some patients may be operated on up to four or five times in the liver. Moreover, these patients probably present an increased risk of postoperative hepatocellular insufficiency due to a quantitative and qualitative decrease in their hepatic parenchyma. It is therefore interesting to evaluate the use of paracetamol in this situation.","other_id":"2015_61","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients requiring surgery for hepatic resection by initiation under chest or\r\n             laparoscopic without hepatocellular insufficiency,\r\n\r\n          -  ASA score 1 to 3 (American Society of Anesthesiologists score ranging from 1 to 5\r\n             evaluating the preoperative health status of a patient),\r\n\r\n          -  Verification of the understanding of the protocol,\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients classified ASA 4 or 5,\r\n\r\n          -  Allergy or intolerance to indocyanine green\r\n\r\n          -  Allergy or intolerance to paracetamol,\r\n\r\n          -  Taking of paracetamol the week before the intervention,\r\n\r\n          -  Patient less than 60 Kgs (because decrease of doses of paracetamol),\r\n\r\n          -  Emergency surgery, palliative surgery and surgical recovery,\r\n\r\n          -  Psychic disorder,\r\n\r\n          -  Contra-indication to a treatment used during the study,\r\n\r\n          -  incapable major,\r\n\r\n          -  Intellectual incapacity preventing proper understanding of the protocol,\r\n\r\n          -  Pregnant or nursing woman,\r\n      ","sponsor":"University Hospital, Lille","sponsor_type":"Other","conditions":"Paracetamol Causing Adverse Effects in Therapeutic Use|Hepatic Disease","interventions":[{"intervention_type":"Drug","name":"Drug: paracetamol","description":"Paracetamol 1000 mg will be administered 30 minutes before the end of the procedure and then every 6 hours systematically at the following times: 6h / 12h / 18h / 00h.\r\nThe analgesic treatment after hepatectomy with paracetamol will be maintained for at least 5 days in all patients in parenteral form"},{"intervention_type":"Procedure","name":"Procedure: hepatic surgery"}],"outcomes":[{"outcome_type":"primary","measure":"Dosing and kinetics of paracetamolemia","time_frame":"during the 5 post-operative days","description":"this determination of the plasma paracetamol dosage on D0 (H6: 6 hours after the end of the procedure) and D1 D2 D3 D4 D5 (samples taken at 6 am each day just before the injection of paracetamol whose administration hours will be 6h 12h 18h and midnight)"},{"outcome_type":"secondary","measure":"Dosage of urinary metabolites of paracetamol (paracetamol sulphate, paracetamol glucuronide)","time_frame":"At Day 1, day 3, day 5 post operative"},{"outcome_type":"secondary","measure":"Dosage of N-acetyl-cysteinyl paracetamol ( NAPQI)","time_frame":"At Day 1, day 3, day 5 post operative"},{"outcome_type":"secondary","measure":"Percentage of patients with paracetamolemia greater than 60 mg / mL","time_frame":"during the 5 post-operative days","description":"60mj/ml = paracetamol toxicity threshold according to Prescott diagram to 6 hours"},{"outcome_type":"secondary","measure":"Plasma Disappearance Rate of indocyanine green (TDP-ICG) by LiMon®","time_frame":"At Day 1, day 3, day 5 post operative"},{"outcome_type":"secondary","measure":"Rate of postoperative hepatocellular insufficiency","time_frame":"at day 5","description":"The postoperative hepatocellular insufficiency according to the 50/50 criteria (TP <50% and bilirubinemia> 50 μmol / L on the 5th day) according to the type of hepatic resection (with or without clamping, continuous or discontinuous, duration intervention)."},{"outcome_type":"secondary","measure":"Occurrence of complications related to hepatic failure","time_frame":"at day 5","description":"the complications related to hepatic failure not falling within the \"50/50\" criteria: jaundice, hepatic encephalopathy, coagulation disorders, ascites, cytolysis, cholestasis.\r\nOther medical and surgical. Duration of hospitalization in perioperative intensive care and duration of total hospitalization.\r\nMortality at 30 days."},{"outcome_type":"secondary","measure":"Duration of hospitalization in perioperative intensive care","time_frame":"at 30 days"},{"outcome_type":"secondary","measure":"Duration of total hospitalization.","time_frame":"at 30 days"},{"outcome_type":"secondary","measure":"Mortality","time_frame":"at 30 days"},{"outcome_type":"secondary","measure":"Composite characteristics of surgery.","time_frame":"at 30 days","description":"Characteristics of surgery: duration of intervention, numbers, duration and types of vascular clamping, detailed description of the type of liver resection performed, quantification of bleeding."}]}
{"nct_id":"NCT04087200","start_date":"2016-12-01","enrollment":2500,"brief_title":"Protective Effect of Early High Dose stATins On Cardiovascular and Renal Events in Acute Coronary Syndrome","official_title":"The Protective Effect of Early High Dose High-intensity Statins on Cardiovascular and Renal Events in Patients With Acute Coronary Syndrome","primary_completion_date":"2025-12-01","study_type":"Observational [Patient Registry]","rec_status":"Recruiting","completion_date":"2026-12-01","last_update":"2019-09-12","description":"Registration of all ACS patients (STEMI and NSTEMI) admitted to the cardiology ward and scheduled for early invasive strategy. The aim is to evaluate the protective effects of early (on admission) high-dose high-potency statin therapy on early and mid-term cardiac and renal events in this subset of patients.","other_id":"OSS 15.161","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","population":"Statin-naive patients and those on statin therapy with ACS (both STEMI and NSTEMI)","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Acute coronary syndrome (ST elevation and non ST elevation)\r\n\r\n          -  Early invasive strategy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  contraindication to statin therapy\r\n\r\n          -  refusal of consent\r\n      ","sponsor":"Centro Cardiopatici Toscani","sponsor_type":"Other","conditions":"Acute Coronary Syndrome","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Acute renal function changes","time_frame":"Within 72 hours after hospital admission","description":"Changes in creatinine and/or cystatine values"},{"outcome_type":"primary","measure":"Inflammatory profile changes","time_frame":"up to 1 month","description":"Changes from baseline in CRP values"},{"outcome_type":"primary","measure":"Lipid profile changes","time_frame":"up to 1 month","description":"Changes from baseline in cholesterol values"},{"outcome_type":"primary","measure":"Platelet count","time_frame":"up to 1 month","description":"Changes from baseline in platelet count"},{"outcome_type":"primary","measure":"Platelet volume","time_frame":"up to 1 month","description":"Changes from baseline in platelet volume"},{"outcome_type":"primary","measure":"Platelet aggregation profile","time_frame":"up to 1 month","description":"Changes from baseline in platelet reactivity (Verify Now)"},{"outcome_type":"secondary","measure":"Major cardiovascular adverse events","time_frame":"up to 12 months","description":"Death, myocardial infarction, stroke or coronary revascularization"},{"outcome_type":"secondary","measure":"Renal function changes","time_frame":"Changes from baseline at 1 month","description":"glomerular filtration rate"},{"outcome_type":"secondary","measure":"Major adverse cardiovascular and renal adverse events","time_frame":"up to 1 month","description":"Death, myocardial infarction, stroke, coronary revascularization or glomerular filtration rate reduction > = 25% compared to baseline"},{"outcome_type":"other","measure":"Impact of age and frailty profile on primary and secondary outcomes","time_frame":"Up to 1 month","description":"Frailty evaluation (combination of FRAIL scale questionnaire and hand-grip strength measurement)"}]}
{"nct_id":"NCT02931383","start_date":"2016-11-30","phase":"Phase 4","enrollment":150,"brief_title":"Ultrasound of the Knee in Obese Patients With Knee Osteoarthritis; Weight Maintenance","official_title":"Ultrasound of the Knee in Obese Patients With Knee Osteoarthritis Following Liraglutide Treatment, Investigating the Impact on Inflammation","primary_completion_date":"2019-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-03-31","last_update":"2019-03-25","description":"This is a substudy to a randomised trial investigating the effect of liraglutide on body weight and pain in overweight or obese patients with knee osteoarthritis (OA) (NCT02905864). In the parent trial, patients will be subjected to an 8-week diet intervention phase including a low-calorie diet and dietetic counseling, after which patients will be randomised to receive either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on re-introducing regular foods and a focus on continued motivation to engage in a healthy lifestyle. This substudy aims to investigate the impact of, and subsequent change of, joint inflammation and clinical symptoms, in obese patients with knee osteoarthritis following a randomisation to Liraglutide 3 mg or Liraglutide 3 mg placebo treatment between weeks 0-52.","other_id":"137.07","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":74,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Informed consent obtained\r\n\r\n          -  Clinical diagnosis of knee OA (American College of Rheumatology (ACR) criteria)\r\n             confirmed by radiology but restricted to definite radiographic OA at early to\r\n             moderate-stages (Kellgren-Lawrence grades 1, 2, or 3)\r\n\r\n          -  Age  18 years and < 75 years\r\n\r\n          -  Body mass index (BMI)  27 kg/m2\r\n\r\n          -  Stable body weight during the previous 3 months (< 5 kg self-reported weight change)\r\n\r\n          -  Motivated for weight loss\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  On-going participation, or participation within the last 3 months, in an organised\r\n             weight loss programme (or within the last 3 months)\r\n\r\n          -  Current or history of treatment with medications that may cause significant weight\r\n             gain for at least 3 months before this trial\r\n\r\n          -  Current use or use within three months before this trial of GLP-1 receptor agonist,\r\n             pramlintide, sibutramine, orlistat, zonisamide, topiramate, or phentermine\r\n\r\n          -  Type 1 diabetes\r\n\r\n          -  Type 2 diabetes treated with glucose-lowering drugs other than metformin\r\n\r\n          -  Alloplasty in target knee joint (see section 6.3)\r\n\r\n          -  End stage disease in target knee joint (Kellgren-Lawrence grade 4)\r\n\r\n          -  Immuno-inflammatory disease\r\n\r\n          -  Chronic wide-spread pain\r\n\r\n          -  Pregnancy or insufficient anti-conception therapy for female fertile patients\r\n\r\n          -  Breast-feeding\r\n\r\n          -  Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m2\r\n\r\n          -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 x above upper\r\n             normal range (UNR)\r\n\r\n          -  Surgery scheduled for the trial duration period, except for minor surgical procedures\r\n\r\n          -  Surgical procedures such as arthroscopy or injections into a knee within 3 months\r\n             prior to enrolment\r\n\r\n          -  Previous surgical treatment for obesity (excluding liposuction >1 year before trial\r\n             entry)\r\n\r\n          -  Thyroid stimulating hormone (TSH) outside of the range of 0.4-6.0 mIU/L\r\n\r\n          -  Obesity secondary to endocrinologic or eating disorders or to treatment with medicinal\r\n             products that may cause weight gain\r\n\r\n          -  Family or personal history of medullary thyroid carcinoma or multiple endocrine\r\n             neoplasia type 2\r\n\r\n          -  Inflammatory bowel disease\r\n\r\n          -  Congestive heart failure, New York Heart Association (NYHA) class III-IV\r\n\r\n          -  Diabetic gastroparesis\r\n\r\n          -  History of or current diagnosis of pancreatitis (acute and/or chronic) or pancreatic\r\n             cancer\r\n\r\n          -  History of cancer with the exception of in-situ malignancies of the skin or cervix\r\n             uteri\r\n\r\n          -  History of major depressive disorder, a PHQ-9 (Patient Health Questionnaire-9) score\r\n             of more than 15, or a history of other severe psychiatric disorders or diagnosis of an\r\n             eating disorder\r\n\r\n          -  Subjects with a lifetime history of a suicide attempt or history of any suicidal\r\n             behaviour within the past month before entry into the trial\r\n\r\n          -  Inability to speak Danish fluently\r\n\r\n          -  A mental state impeding compliance with the program\r\n\r\n          -  Use of opioids or similar strong analgesics\r\n\r\n          -  Allergic reactions to the active ingredients of Saxenda, such as hypotension,\r\n             palpitations, dyspnoea and oedema\r\n      ","sponsor":"Henrik Gudbergsen","sponsor_type":"Other","conditions":"Osteoarthritis|Obesity","interventions":[{"intervention_type":"Drug","name":"Drug: Liraglutide 3 mg (Saxenda)"},{"intervention_type":"Drug","name":"Drug: Liraglutide 3 mg placebo"}],"outcomes":[{"outcome_type":"secondary","measure":"Change in knee-joint effusion","time_frame":"Week 0 to 52","description":"Change in effusion will be assessed via the US knee OA musculoskeletal ultrasound score (MUS) score (Riecke BF et al.)"},{"outcome_type":"secondary","measure":"Change in the degree of inflammation in the knee-joint (Greyscale-size)","time_frame":"Week 0 to 52","description":"Change will be assessed by grey-scale ultrasound in the suprapatellar, the medial, and the lateral recess´ (sum of size-scores (mm) of these three positions)"},{"outcome_type":"secondary","measure":"Change in the degree of inflammation in the knee-joint (Doppler-score)","time_frame":"Week 0 to 52","description":"Change will be assessed by Doppler ultrasound in the suprapatellar, the medial, and the lateral recess´ (sum-score (0-9), derived from these three positions)"},{"outcome_type":"primary","measure":"Change in the degree of inflammation in the knee-joint (Greyscale-score)","time_frame":"Week 0 to 52","description":"Change will be assessed by grey-scale ultrasound (US) in the suprapatellar, the medial, and the lateral recess´ (sum-score (0-9), derived from these three positions)"}]}
{"nct_id":"NCT02951195","start_date":"2016-11-30","phase":"Phase 2","enrollment":80,"brief_title":"A Study Evaluating the Safety of VX-152 Combination Therapy in Adults With Cystic Fibrosis","official_title":"A Phase 2, Randomized, Double Blind, Controlled Study to Evaluate the Safety of VX-152 Combination Therapy in Adults With Cystic Fibrosis","primary_completion_date":"2018-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-01-31","last_update":"2021-01-28","description":"This is a Phase 2, randomized, double blind, placebo and active-controlled, parallel group, multicenter study designed to evaluate the safety and tolerability of VX-152 in Triple Combination (TC) with tezacaftor (TEZ; VX-661) and ivacaftor (IVA; VX-770) in subjects with cystic fibrosis (CF) who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ and/or IVA therapy (F508del/MF), or who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F508del/F508del).","other_id":"VX16-152-102","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Willing and able to comply with scheduled visits, treatment pan, study restrictions,\r\n             laboratory tests, contraceptive guidelines, and other study procedures.\r\n\r\n          -  Body weight 35 kg.\r\n\r\n          -  Sweat chloride value  60 mmol/L from test results obtained during screening.\r\n\r\n          -  Subjects must have an eligible CFTR genotype:\r\n\r\n               -  Cohorts 1A, 1B, 1C: Heterozygous for F508del and a minimal function mutation\r\n                  known or predicted not to respond to TEZ and/or IVA.\r\n\r\n               -  Cohorts 2A, 2B: Homozygous for F508del.\r\n\r\n          -  Subjects must have an FEV1 40% and 90% of predicted normal for age, sex, and height\r\n             at the Screening Visit.\r\n\r\n          -  Stable CF disease as judged by the investigator.\r\n\r\n          -  Willing to remain on a stable CF medication regimen through the planned end of\r\n             treatment or if applicable the Safety Follow-up Visit.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of any comorbidity that in the opinion of the investigator might confound the\r\n             results of the study or pose an additional risk in administering study drug to the\r\n             subject.\r\n\r\n          -  History of cirrhosis with portal hypertension.\r\n\r\n          -  Risk factors for Torsade de Pointes.\r\n\r\n          -  History of hemolysis.\r\n\r\n          -  Glucose-6-phosphate dehydrogenase (G6PD) deficiency assessed at Screening.\r\n\r\n          -  Clinically significant abnormal laboratory values at screening.\r\n\r\n          -  An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in\r\n             therapy for pulmonary disease within 28 days before the first dose of study drug.\r\n\r\n          -  Lung infection with organisms associated with a more rapid decline in pulmonary\r\n             status.\r\n\r\n          -  An acute illness not related to CF within 14 days before the first dose of study drug.\r\n\r\n          -  A standard digital ECG demonstrating QTc >450 msec at screening.\r\n\r\n          -  History of solid organ or hematological transplantation.\r\n\r\n          -  History or evidence of cataract or lens opacity determined to be clinically\r\n             significant by the ophthalmologist or optometrist, based on the ophthalmologic\r\n             examination during the Screening Period.\r\n\r\n          -  History of alcohol or drug abuse in the past year, including but not limited to,\r\n             cannabis, cocaine, and opiates, as deemed by the investigator.\r\n\r\n          -  Ongoing or prior participation in an investigational drug study with certain\r\n             exceptions.\r\n\r\n          -  Use of commercially available CFTR modulator within 14 days before screening (applies\r\n             only to Cohorts 1A, 1B, and 1C).\r\n\r\n          -  Pregnant or nursing females: Females of childbearing potential must have a negative\r\n             pregnancy test at screening and Day 1.\r\n      ","sponsor":"Vertex Pharmaceuticals Incorporated","sponsor_type":"Industry","conditions":"Cystic Fibrosis","interventions":[{"intervention_type":"Drug","name":"Drug: VX-152","description":"Tablet for oral administration."},{"intervention_type":"Drug","name":"Drug: TEZ/IVA","description":"Fixed-dose combination tablet for oral administration."},{"intervention_type":"Drug","name":"Drug: IVA","description":"Tablet for oral administration."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo matched to VX-152."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo matched to VX-152/TEZ/IVA triple combination (TC)."}],"outcomes":[{"outcome_type":"primary","measure":"Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)","time_frame":"Day 1 Through Safety Follow-up Visit (Up to Day 43 for Part 1 and Day 71 for Part 2)"},{"outcome_type":"primary","measure":"Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Day 15 for Part 1 and Part 2 Cohort 2A","time_frame":"From Baseline at Day 15","description":"FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration."},{"outcome_type":"primary","measure":"Absolute Change in ppFEV1 Through Day 29 for Part 2 Cohort 2B","time_frame":"From Baseline Through Day 29","description":"FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration."},{"outcome_type":"secondary","measure":"Absolute Change in Sweat Chloride Concentrations at Day 15 for Part 1 and Part 2 Cohort 2A","time_frame":"From Baseline at Day 15","description":"Sweat samples were collected using an approved collection device."},{"outcome_type":"secondary","measure":"Absolute Change in Sweat Chloride Concentrations Through Day 29 for Part 2 Cohort 2B","time_frame":"From Baseline Through Day 29","description":"Sweat samples were collected using an approved collection device."},{"outcome_type":"secondary","measure":"Relative Change in ppFEV1 at Day 15 for Part 1 and Part 2 Cohort 2A","time_frame":"From Baseline at Day 15","description":"FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration."},{"outcome_type":"secondary","measure":"Relative Change in ppFEV1 Through Day 29 for Part 2 Cohort 2B","time_frame":"From Baseline Through Day 29","description":"FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration."},{"outcome_type":"secondary","measure":"Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Day 15 for Part 1 and Part 2 Cohort 2A","time_frame":"From Baseline at Day 15","description":"The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life."},{"outcome_type":"secondary","measure":"Absolute Change From Baseline in CFQ-R Respiratory Domain Score at Day 29 for Part 2 Cohort 2B","time_frame":"From Baseline at Day 29","description":"The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life."},{"outcome_type":"secondary","measure":"Pre-dose Plasma Concentration (Ctrough) of VX-152, TEZ, M1-TEZ, IVA, and M1-IVA","time_frame":"Pre-dose at Day 8, Day 15 and Day 29"}]}
{"nct_id":"NCT03286816","start_date":"2016-11-30","phase":"N/A","enrollment":19,"brief_title":"The Effect of Intravenous Lactate on Brain Lactate Concentrations During Hypoglycemia","official_title":"The Effect of Intravenous Lactate Administration on Brain Lactate Concentrations and pH During Euglycemia and Hypoglycemia in Patients With Type 1 Diabetes With and Without Impaired Awareness of Hypoglycemia","primary_completion_date":"2017-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-08-31","last_update":"2017-09-19","description":"Patients with type 1 diabetes (T1DM) who are unable to perceive symptoms of hypoglycemia, referred to as impaired awareness of hypoglycemia (IAH), are at very high risk of severe hypoglycemia. IAH affects approximately 25% of patients with T1DM. Brain lactate may be involved in the development of IAH. A recent study indicated increased brain lactate utilization during hypoglycemia in T1DM patients with IAH, which did not occur in patients with normal awareness of hypoglycemia (NAH). Conversely, administration of lactate to patients with NAH has been shown to attenuate counterregulatory hormone responses to and symptomatic awareness of hypoglycemia, thus causing a situation that resembles IAH. It has, however, not been demonstrated whether the excess of lactate is actually taken up or metabolized by the brain, and if so whether this occurs under euglycemic or hypoglycemic conditions or both. This project consists of two related studies. The objective of part 1 is to investigate the effect of elevated plasma lactate levels that are sufficient to impair awareness of hypoglycemia on brain lactate concentrations during euglycemia and hypoglycemia in T1DM patients with NAH. The objective of part 2 is to compare the effect of exogenous lactate on brain lactate concentrations between T1DM patients with NAH and T1DM patients with IAH. Furthermore, this study aims to determine the effect of acute hypoglycemia on the inflammatory function and composition of peripheral blood mononuclear cells.","other_id":"Lac_iv","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Basic Science","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diabetes duration  1 year\r\n\r\n          -  Age: 18-50 years\r\n\r\n          -  Body-Mass Index: 18-30 kg/m2\r\n\r\n          -  HbA1c: 42-75 mmol/mol (6-9%)\r\n\r\n          -  Outcome Clarke questionnaire: 0-1 or >=3\r\n\r\n          -  Blood pressure: <160/90 mmHg\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Inability to provide informed consent\r\n\r\n          -  Use medication other than insulin, except for oral contraceptives or stable thyroxin\r\n             supplementation therapy\r\n\r\n          -  Presence of any other medical condition that might interfere with the study protocol,\r\n             such as brain injuries, epilepsy, a major cardiovascular disease event, known liver\r\n             disease, anxiety disorders or a history of panic attacks.\r\n\r\n          -  Microvascular complications of T1DM: Proliferative retinopathy, Symptomatic diabetic\r\n             neuropathy (including autonomic neuropathy), Nephropathy; clinical/overt albuminuria\r\n             or an estimated glomerular filtration rate <60ml/min/1.73m2\r\n\r\n          -  MR(I) contraindications (pregnancy, severe claustrophobia, metal parts in body)\r\n      ","sponsor":"Radboud University","sponsor_type":"Other","conditions":"Type 1 Diabetes Mellitus With Hypoglycemia","interventions":[{"intervention_type":"Drug","name":"Drug: SodiumChloride"},{"intervention_type":"Drug","name":"Drug: Sodium Lactate"}],"outcomes":[{"outcome_type":"primary","measure":"the effect of intravenous lactate administration, compared to placebo, on brain lactate concentrations during euglycemia and hypoglycemia in patients with T1DM and normal awareness of hypoglycemia","time_frame":"during stable euglycemia (40 min) and hypoglycemia (45 min)"},{"outcome_type":"primary","measure":"the effect of exogenous lactate on brain lactate concentrations during euglycemia and hypoglycemia between T1DM patients with normal awareness of hypoglycemia and T1DM patients with impaired awareness of hypoglycemia","time_frame":"during stable euglycemia (40 min) and hypoglycemia (45 min)"},{"outcome_type":"secondary","measure":"The changes in counterregulatory hormone and to hypoglycemia in response to lactate infusion, compared to placebo, in patients with normal awareness of hypoglycemia","time_frame":"during stable euglycemia (40 min) and hypoglycemia (45 min)"},{"outcome_type":"secondary","measure":"The changes in and symptoms to hypoglycemia in response to lactate infusion, compared to placebo, in patients with normal awareness of hypoglycemia","time_frame":"during stable euglycemia (40 min) and hypoglycemia (45 min)"},{"outcome_type":"secondary","measure":"The changes in brain pH in response to intravenous lactate administration, compared to placebo","time_frame":"during stable euglycemia (40 min) and hypoglycemia (45 min)"},{"outcome_type":"secondary","measure":"Changes in immune cell composition capacity in response to hypoglycemia compared to euglycemia and in response to lactate infusion compared to placebo","time_frame":"during stable euglycemia (40 min) and hypoglycemia (45 min)"},{"outcome_type":"secondary","measure":"Changes in immune cell cytokine production capacity in response to hypoglycemia compared to euglycemia and in response to lactate infusion compared to placebo","time_frame":"during stable euglycemia (40 min) and hypoglycemia (45 min)"}]}
{"nct_id":"NCT03038646","start_date":"2016-11-30","phase":"Phase 1","enrollment":14,"brief_title":"A Pharmacokinetic Study of Modified Release (MR) Formulations of MIN-101 in Healthy Subjects","official_title":"A Phase 1, Open-Label, Randomised, 3-Treatment, 3-Period, Single-Dose, Crossover Study in Healthy Subjects to Compare the Pharmacokinetic Properties of Modified Release (MR) Formulations of MIN-101 Followed by Food Effect Testing of a Selected Formulation","primary_completion_date":"2017-04-20","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-04-20","last_update":"2017-08-31","description":"- To evaluate the pharmacokinetic (PK) profiles of MIN-l0l following administration of modified release (MR) formulations of MIN-l0l in healthy male and female subjects - To select 1 MR formulation for use in fed state - To evaluate the effect of food on the bioavailability of MIN-l0l selected MR formulation","other_id":"MIN-101C06","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":64,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Confirmed CYP 2D6 extensive metaboliser genotype\r\n\r\n          2. Subject has given voluntary written informed consent before performance of any study\r\n             related procedure\r\n\r\n          3. Must be 18 to 45 years of age, inclusive\r\n\r\n          4. Subject must be a healthy male or female as indicated by the protocol\r\n\r\n          5. Agree to abstain from all medication (except for allowed birth control for 21 days\r\n             before the first dose with MIN-101\r\n\r\n          6. Subject agrees to use the methods of birth control as outlined in the protocol\r\n\r\n          7. Must be willing and able to communicate and participate in the whole study.\r\n\r\n          8. Willing to eat all the food supplied throughout the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. A history of clinically significant gastrointestinal disease, renal, hepatic,\r\n             neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic or psychiatric\r\n             disease or any other condition which, in the opinion of the principle investigator,\r\n             would jeopardize the safety of the subject or impact the validity of the study results\r\n\r\n          2. Acute diarrhoea or constipation in the 7 days before the predicted first study day.\r\n\r\n          3. Subject has donated blood within 90 days or plasma within 30 days of study dosing\r\n\r\n          4. Regular alcohol consumption in males> 21 units per week and Females > 14 units per\r\n             week (1 Unit = 1/2 pint beer, 25 mL of 40or a 125 mL glass of wine)\r\n\r\n          5. Subject has a borderline or long QTc Fridericia interval as defined by screening\r\n             readings of >430 msec for males and >440 for females or a personal or familial history\r\n             of long QT syndrome\r\n\r\n          6. Subject has participated in a clinical trial within 90 days prior to study initiation\r\n\r\n          7. Females who are pregnant or breast feeding\r\n\r\n          8. Subject has used any prescription medication or over-the-counter (OTC) medication,\r\n             including vitamin supplements, within 21 days prior to day l\r\n\r\n          9. Subject has been treated with any known P450 206 or 3A4 enzymes altering drugs within\r\n             30 days prior to the study\r\n\r\n         10. Subject has smoked or used nicotine products within 2 months prior to or during the\r\n             study\r\n\r\n         11. Subject has sought advice from or been referred to a GP or counsellor for abuse or\r\n             misuse of alcohol, non-medical drugs, medicinal drugs or other substance abuse, e.g.\r\n             solvents\r\n\r\n         12. Subject has a positive blood screen for HIV, Hepatitis B surface antigen (HBsAg), and\r\n             Hepatitis C Antibody\r\n\r\n         13. Any current or previous use of drugs such as opiates, cocaine, ecstasy, or intravenous\r\n             amphetamines and/or a positive urine screen for alcohol or drugs of abuse. Subjects\r\n             who admit to occasional past use of cannabis will not be excluded as long as they have\r\n             a negative drugs-of-abuse test and have been abstinent from cannabis use for at least\r\n             3 months\r\n\r\n         14. Subject has a current uncontrolled inter-current illness (i.e., active infection) or\r\n             has had a clinically significant illness within the last 30 days prior to Day 1\r\n\r\n         15. Subject has had major surgery within 28 days of study entry, or 12 months prior to\r\n             study for gastrointestinal surgery.\r\n\r\n         16. Failure to satisfy the investigator of fitness to participate for any other reason.\r\n      ","sponsor":"Minerva Neurosciences","sponsor_type":"Industry","conditions":"Healthy Subjects","interventions":[{"intervention_type":"Drug","name":"Drug: MIN-101"}],"outcomes":[{"outcome_type":"primary","measure":"Part 1: Plasma PK parameter, Cmax","time_frame":"from predose up to 72 hours post dose: Blood samples for MIN-101 will be collected at time 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 48, 60, and 72 hours post-dose on Day 1 of all periods.","description":"To estimate the relative bioavailability of MIN-l0l following MIN-101 administration. Plasma samples will be analyzed for MIN-101 and its metabolites using a validated LC-MS/MS method"},{"outcome_type":"primary","measure":"Part 1: Plasma PK parameter, Tmax","time_frame":"from predose up to 72 hours post dose"},{"outcome_type":"primary","measure":"Part 1: Plasma PK parameter, Tlag","time_frame":"from predose up to 72 hours post dose"},{"outcome_type":"primary","measure":"Part 1: Plasma PK parameter,partial AUC (e.g., AUC12, AUC24), AUClast, AUC∞","time_frame":"from predose up to 72 hours post dose"},{"outcome_type":"primary","measure":"Part 1: Plasma PK parameter, λz and t1/2","time_frame":"from predose up to 72 hours post dose"},{"outcome_type":"primary","measure":"Part 2: Plasma PK parameter, Cmax","time_frame":"from predose up to 72 hours post dose: Blood samples for MIN-101 will be collected at time 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 48, 60, and 72 hours post-dose on Day 1 of all periods.","description":"To estimate the relative bioavailability of MIN-101 and its main metabolites following the administration of the selected modified release formulation in different food conditions (fasted or fed state)."},{"outcome_type":"primary","measure":"Part 2: Plasma PK parameter, Tmax","time_frame":"from predose up to 72 hours post dose"},{"outcome_type":"primary","measure":"Part 2: Plasma PK parameter, Tlag","time_frame":"from predose up to 72 hours post dose"},{"outcome_type":"primary","measure":"Part 2: Plasma PK parameter, λz and t1/2","time_frame":"from predose up to 72 hours post dose"},{"outcome_type":"secondary","measure":"Part 1: QTcF changes from baseline","time_frame":"from predose up to 72 hours post dose","description":"The effect of coincidentally measured (time-matched) plasma concentrations of MIN-l0l on QTcF changes from Baseline."},{"outcome_type":"secondary","measure":"Part 1: Safety (AE reporting, safety laboratory parameters analysis, vital signs and 12 lead ECG assessments)","time_frame":"2 months 16 days","description":"Safety will be assessed through AE reporting, safety laboratory parameters analysis, vital signs and 12 lead ECG assessments"},{"outcome_type":"secondary","measure":"Part 2: Safety (AE reporting, safety laboratory parameters analysis, vital signs and 12 lead ECG assessments)","time_frame":"2 months 16 days","description":"Safety will be assessed through AE reporting, safety laboratory parameters analysis, vital signs and 12 lead ECG assessments"}]}
{"nct_id":"NCT03068078","start_date":"2016-11-30","phase":"N/A","enrollment":185,"brief_title":"A Reduced-carbohydrate Diet High in Monounsaturated Fats in Type 2 Diabetes","official_title":"A Reduced-carbohydrate Diet High in Monounsaturated Fats in Type 2 Diabetes: a Six-month Study of Changes in Metabolism, Liver- and Cardiovascular Function (ReDuCtion)","primary_completion_date":"2021-06-04","study_type":"Interventional","rec_status":"Completed","completion_date":"2021-06-04","last_update":"2021-07-02","description":"Further studies are needed to establish the optimal diet for treating T2D. The investigators wishes to investigate whether a low carbohydrate diet, high in monounsaturated fats (LCD) will affect cardiovascular function, metabolism and the liver. 135 participants with T2D, will be following either a LCD, or a regular diabetes diet (RDD) for 6 months. Measurements and investigations will be performed at baseline and after 6 months.","other_id":"S-20150217","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Duration of established T2D for more than six months and less than five years and\r\n             HbA1c in compliance with T2D (above 48 mmol/mol), but without need for adjustment of\r\n             antidiabetic treatment*\r\n\r\n          2. Serum cholesterol below 4.5 mmol/l and LDL cholesterol below 2.5 mmol/l at inclusion**\r\n\r\n          3. Age of 18 or above\r\n\r\n          4. Stable diabetic treatment three months prior to inclusion***\r\n\r\n          5. Be able to read and understand Danish language\r\n\r\n          6. Signed written consent\r\n\r\n               -  based on the assumption that metabolic and cardiovascular changes are less likely\r\n                  to be reversible in patients with longstanding T2D. HbA1c and need for adjustment\r\n                  and if the patient is eligible for inclusion will be evaluated individually based\r\n                  on the patients current treatment and current HbA1c by the project responsible.\r\n                  If the patient has duration of diabetes > 5 years but with current treatment  2\r\n                  oral antidiabetic drugs and without insulin treatment, the patient will be\r\n                  accepted for enrolment.\r\n\r\n                    -  To avoid changes in lipid-lowering treatment during follow-up total\r\n                       cholesterol should be below 4.5 mmol/l and LDL cholesterol below 2.5 mmol/l\r\n                       at inclusion. Higher levels may be accepted if the patient cannot tolerate\r\n                       lipid-lowering treatment ***Patients can be enrolled three months after\r\n                       medication change\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Low carbohydrate diet prior to inclusion\r\n\r\n          2. Hypoglycemic unawareness\r\n\r\n          3. Excessive weight loss within the last three months, defined as more than 10 kilograms\r\n\r\n          4. Current treatment with glucocorticoids (systemic)\r\n\r\n          5. Continuous treatment with steatosis-inducing drugs (e.g. carbamazepine)\r\n\r\n          6. Treatment with antibiotics up to 2 months before inclusion*\r\n\r\n          7. Treatment with chemotherapy\r\n\r\n          8. Pregnancy or expected pregnancy within the next 6 months\r\n\r\n          9. Active alcohol overuse**\r\n\r\n         10. Active cancer\r\n\r\n         11. Significant co morbidity including liver disease\r\n\r\n         12. Poor compliance *Participants can be rescheduled to be included 2 months after use of\r\n             antibiotics ** Prior alcohol overuse and eligibility will be evaluated individually\r\n      ","sponsor":"Odense University Hospital","sponsor_type":"Other","conditions":"Type2 Diabetes|Nonalcoholic Steatohepatitis|Non-Alcoholic Fatty Liver Disease|Atherosclerosis|Dyslipidemias","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Low carbohydrate diet high in monounsaturated fats","description":"Participants will have to change their diet during 6 months"}],"outcomes":[{"outcome_type":"primary","measure":"Glycemic control, dyslipidemia and metabolic markers","time_frame":"Change from baseline at 6 months","description":"Measured by HbA1c, serum cholesterol, blood glucose and metabolic markers"},{"outcome_type":"secondary","measure":"Endothelial function","time_frame":"Change from baseline at 6 months","description":"assessed by FMD in the brachial artery as well as microvascular damage assessed by retinal scan, urine albuminuria and minimal forearm vascular resistance (MFVR)."},{"outcome_type":"secondary","measure":"Non-Alcoholic Fatty Liver Disease (NAFLD)","time_frame":"Change from baseline at 6 months","description":"Assessed by >2 points reduction in NAFLD Activity score with at least 1 point reduction in either lobular inflammation or hepatocellular ballooning, without worsening of fibrosis."},{"outcome_type":"secondary","measure":"Quality of life","time_frame":"Change from baseline at 6 months","description":"Assessed by questionaire"},{"outcome_type":"secondary","measure":"Gut dysbiosis","time_frame":"Change from baseline at 6 months","description":"Assessed by fecal sample"}]}
{"nct_id":"NCT03084237","start_date":"2016-11-30","phase":"Phase 3","enrollment":649,"brief_title":"Compare Efficacy, Safety and Immunogenicity of HLX02 and Herceptin in Previously Untreated HER2 +Overexpressing Metastatic Breast Cancer","official_title":"Double-blind, Randomized, Multicenter, Phase III Clinical Study to Compare the Efficacy and to Evaluate the Safety and Immunogenicity of Trastuzumab Biosimilar HLX02 and EU-sourced Herceptin in Previously Untreated HER2 Overexpressing Metastatic Breast Cancer","primary_completion_date":"2018-11-23","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2021-09-01","last_update":"2020-09-11","description":"This is a Phase III, double-blind, randomized multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of HLX02 and European Union (EU)-sourced Herceptin in patients with human epidermal growth factor receptor 2 (HER2)-positive, locally recurrent or previously untreated metastatic breast cancer.","other_id":"HLX02-BC01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria\r\n\r\n          -  Patients have voluntarily agreed to participate and given written informed consent.\r\n\r\n          -  Male or female 18 years of age on day of signing the informed consent form (ICF).\r\n\r\n          -  Histologically or cytologically confirmed adenocarcinoma of the breast.\r\n\r\n          -  Recurrent disease not amenable to curative surgery or radiation therapy, or metastatic\r\n             disease with an indication for a taxane-containing therapy.\r\n\r\n          -  Availability of formalin-fixed paraffin-embedded (FFPE) tissue block from the primary\r\n             tumor, or a metastatic lesion, to confirm HER2-positivity by the central laboratory,\r\n             based on FISH amplification ratio 2.0 or IHC score 3+, and for hormone status\r\n             (ER/PgR) determination (local or central laboratory). If not possible, a fresh biopsy\r\n             is required.\r\n\r\n          -  No prior systemic anticancer agent such as chemotherapy, biological or targeted agent\r\n             for metastatic disease with the exception of hormonal therapy, which must be stopped\r\n             at least 2 weeks before randomization. Use of herbal remedies or traditional Chinese\r\n             medicines for anticancer, hematologic or liver function, or anti-infective treatment\r\n             must be stopped at the time of the ICF signature (at least 2 weeks before\r\n             randomization).\r\n\r\n          -  For patients with recurrent disease, prior neo-/adjuvant therapy containing\r\n             trastuzumab and/or lapatinib must have been stopped at least 12 months before the\r\n             diagnosis of recurrent (local or metastatic) disease. If trastuzumab/lapatinib was not\r\n             used, prior neo-/adjuvant therapy with a taxane must have been stopped at least 6\r\n             months before the diagnosis of recurrent (local or metastatic) disease. If only other\r\n             cytotoxics were given, they must be stopped at least 4 weeks before randomization. Any\r\n             hormonal therapy must be stopped at the time of the ICF signature.\r\n\r\n          -  Measurable disease (at least one measurable target lesion assessed by CIR; bone-only\r\n             or central nervous system [CNS]-only metastases are not allowed).\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\r\n\r\n          -  LVEF within institutional range of normal at baseline (within 42 days before\r\n             randomization) as determined by either echocardiography (ECHO) or multigated\r\n             acquisition (MUGA) scan.\r\n\r\n          -  Adequate hematologic, hepatic and renal function as indicated by the following\r\n             laboratory values:\r\n\r\n          -  Absolute neutrophil count (ANC) 1,500/L without granulocyte-colony stimulating\r\n             factor (G-CSF) or other medical support\r\n\r\n          -  Platelets 100,000/L\r\n\r\n          -  Hemoglobin 9 g/dL without transfusion or other medical support within 14 days\r\n\r\n          -  Serum creatinine 1.5 x upper limit of normal (ULN) and creatinine clearance rate 50\r\n             mL/min, calculated according to Cockroft-Gault formula\r\n\r\n          -  Serum total bilirubin 1.5 x ULN (unless the patient has documented Gilbert's\r\n             syndrome) without any medical support within 14 days\r\n\r\n          -  Serum aspartate aminotransferase/glutamicoxaloacetic transaminase (AST/SGOT) or serum\r\n             alanine aminotransferase/glutamate-pyruvate transaminase (ALT/SGPT) 2.5 x ULN (5 x\r\n             ULN in the case of liver metastases) provided alkaline phosphatase (ALK) is 2.5 x\r\n             ULN. In the case of bone metastasis, serum ALK can be >2.5 x ULN if AST and ALT are\r\n             1.5 x ULN without any medical support within 14 days\r\n\r\n          -  International normalized ratio (INR), and activated partial prothrombin time (aPTT) or\r\n             partial prothrombin time (PTT) 1.5 x ULN.\r\n\r\n          -  Estimated life expectancy 3 months.\r\n\r\n          -  Female patients are eligible to enter and participate in the study if they are of:\r\n             Non-childbearing potential. Childbearing potential, have a negative serum pregnancy\r\n             test at Screening, are not breast feeding, and use highly-effective or acceptable\r\n             contraceptive measures before study entry and throughout the study until 7 months\r\n             after the last investigational/comparator product administration. Highly-effective or\r\n             acceptable contraceptive measures.\r\n\r\n          -  Male patients with partners of childbearing potential are eligible to enter and\r\n             participate in the study if they, and their female partners, are willing to use\r\n             highly-effective or acceptable contraceptive measures before study entry and\r\n             throughout the study until 7 months after the last investigational/comparator product\r\n             administration.\r\n\r\n        Exclusion Criteria\r\n\r\n          -  Previously- or currently-treated (systemic chemotherapy, biological, or targeted\r\n             agent, or any other anticancer agent) metastatic breast cancer with the exception of\r\n             hormonal therapy.\r\n\r\n          -  Known brain metastasis or other CNS metastasis that is either symptomatic or\r\n             untreated. Central nervous system metastases that have been treated by complete\r\n             resection and/or radiotherapy demonstrating stability or improvement are not an\r\n             exclusion criterion provided they are stable as shown by computed tomography (CT) scan\r\n             for at least 4 weeks before Screening without evidence of cerebral edema and no\r\n             requirements for corticosteroids or anticonvulsants.\r\n\r\n          -  Participation in another clinical study within 4 weeks before enrollment (3 months for\r\n             studies involving monoclonal therapy) or the intention of participating in another\r\n             clinical study during any part of the study period.\r\n\r\n          -  History of other malignancy within the last 5 years, except for carcinoma in-situ of\r\n             the cervix, basal cell carcinoma or squamous cell carcinoma of the skin that has been\r\n             previously treated with curative intent.\r\n\r\n          -  Known history of human immunodeficiency virus (HIV). Clinically significant active\r\n             infection requiring therapy; positive tests for hepatitis B; or hepatitis C.\r\n\r\n          -  Underlying medical conditions or current severe, uncontrolled systemic disease that,\r\n             in the Investigator's opinion, will make the administration of study drug hazardous. A\r\n             major surgical procedure within 4 weeks prior to enrollment or anticipation of the\r\n             need for major surgery during the course of study.\r\n\r\n          -  Current uncontrolled hypertension (systolic >150 mmHg and/or diastolic >100 mmHg) or\r\n             unstable angina.\r\n\r\n          -  History of chronic heart failure based on any New York Heart Association (NYHA)\r\n             criteria, or left ventricular hypertrophy. Current serious cardiac arrhythmia\r\n             requiring treatment or clinically significant conduction defects as seen on\r\n             electrocardiogram (ECG). History of myocardial infarction within 6 months of\r\n             randomization. History of LVEF decline to below 50% during or after previous\r\n             trastuzumab neo-adjuvant or adjuvant therapy. Significant cardiac murmurs either on\r\n             examination or ECHO.\r\n\r\n          -  History of prior exposure to doxorubicin >360 mg/m (or equivalent). Use of oral,\r\n             injected or implanted hormonal methods of contraception. Chronic daily use of\r\n             corticoids (equivalent to >10 mg/day methylprednisolone) by oral intake (inhalation is\r\n             permitted).\r\n\r\n          -  Known hypersensitivity to any of the study drugs.\r\n\r\n          -  Residual non-hematologic toxicity  Grade 2 from prior therapy.\r\n      ","sponsor":"Shanghai Henlius Biotech","sponsor_type":"Industry","conditions":"Breast Cancer","interventions":[{"intervention_type":"Biological","name":"Biological: HLX02","description":"8 mg/kg administered intravenously over 90 minutes as a loading dose on Day 1, Cycle 1 then 6 mg/kg every 3 weeks for subsequent cycles."},{"intervention_type":"Biological","name":"Biological: Herceptin","description":"8 mg/kg administered intravenously over 90 minutes as a loading dose on Day 1, Cycle 1 then 6 mg/kg every 3 weeks for subsequent cycles"},{"intervention_type":"Drug","name":"Drug: docetaxel","description":"75 mg/m2 will be administered on Day 2, Cycle 1.then be given every 3 weeks on Day 1 of each subsequent cycle"}],"outcomes":[{"outcome_type":"primary","measure":"ORR 24","time_frame":"From time of First treatment to week 24","description":"calculated as the proportion of patients with a best response of complete response (CR) or partial response (PR) from first assessment until Week 24 according to RECIST 1.1."},{"outcome_type":"secondary","measure":"ORR at Week 6, 12, 18, and 24 by CIR","time_frame":"From week 6 to week 24","description":"the probability of being alive 12, 24, and 36 months after randomization"},{"outcome_type":"secondary","measure":"DoR","time_frame":"Up to 2 years","description":"The time from first documentation of CR or PR to the first documentation of progression."},{"outcome_type":"secondary","measure":"DCR","time_frame":"Up to 2 years","description":"The proportion of patients who achieve CR, PR, or stable disease (SD) of at least 12 weeks"},{"outcome_type":"secondary","measure":"CBR","time_frame":"Up to 2 years","description":"The proportion of patients who achieve CR, PR, or durable SD (SD ≥24 weeks)"},{"outcome_type":"secondary","measure":"PFS up to 12 months","time_frame":"From time of first treatment to 12 months","description":"The probability of being alive without documented progression up to 12 months after randomization"},{"outcome_type":"secondary","measure":"Overall survival at 12, 24, and 36 months","time_frame":"From time of first treatment to 36 months","description":"the probability of being alive 12, 24, and 36 months after randomization"}]}
{"nct_id":"NCT03016026","start_date":"2016-11-30","phase":"Phase 2","enrollment":98,"brief_title":"Enhanced Recovery After Surgery (ERAS) on Laparoscopy-assisted Distal Gastrectomy","official_title":"Effect of Enhanced Recovery After Surgery (ERAS) on Laparoscopy-assisted Distal Subtotal Gastrectomy: A Single Arm Trial","primary_completion_date":"2018-06-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2018-07-31","last_update":"2017-01-10","description":"This study evaluates the safety and effectiveness of enhanced recovery after surgery(ERAS) on laparoscopic distal gastrectomy for gastric cancer.All of participants received an ERAS program.","other_id":"ERAS-LAG-01","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age from over 18 to under 75 years\r\n\r\n          -  Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or\r\n             poorly differentiated) confirmed pathologically by endoscopic biopsy\r\n\r\n          -  cT1-4a, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging\r\n             Manual Seventh Edition\r\n\r\n          -  Expected curative resection through distal subtotal gastrectomy with D2\r\n             lymphadenectomy\r\n\r\n          -  no severe organ dysfunction\r\n\r\n          -  Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale\r\n\r\n          -  ASA (American Society of Anesthesiology) score class I or II\r\n\r\n          -  Written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Women during pregnancy or breast-feeding\r\n\r\n          -  Severe mental disorder\r\n\r\n          -  History of previous upper abdominal surgery (except laparoscopic cholecystectomy)\r\n\r\n          -  History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal\r\n             dissection\r\n\r\n          -  Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging\r\n\r\n          -  History of other malignant disease within past five years\r\n\r\n          -  History of previous neoadjuvant chemotherapy or radiotherapy\r\n\r\n          -  History of unstable angina or myocardial infarction within past six months\r\n\r\n          -  History of cerebrovascular accident within past six months\r\n\r\n          -  History of continuous systematic administration of corticosteroids within one month\r\n\r\n          -  Requirement of simultaneous surgery for other disease\r\n\r\n          -  Emergency surgery due to complication (bleeding, obstruction or perforation) caused by\r\n             gastric cancer\r\n\r\n          -  FEV1<50% of predicted values\r\n      ","sponsor":"Nanfang Hospital of Southern Medical University","sponsor_type":"Other","conditions":"Stomach Neoplasms","interventions":[{"intervention_type":"Procedure","name":"Procedure: ERAS","description":"Undergo an ERAS program"}],"outcomes":[{"outcome_type":"primary","measure":"Rehabilitative rate","time_frame":"4 days","description":"Postoperative 4 days"},{"outcome_type":"secondary","measure":"Mortality rates","time_frame":"30 days"},{"outcome_type":"secondary","measure":"Medical cost","time_frame":"1 month","description":"From surgery to discharge"},{"outcome_type":"secondary","measure":"Postoperative pain score","time_frame":"4 days","description":"Postoperative 4 days"},{"outcome_type":"secondary","measure":"Postoperative recovery index","time_frame":"1 month"},{"outcome_type":"secondary","measure":"Postoperative inflammatory immune response","time_frame":"4 days","description":"Postoperative 4 days"},{"outcome_type":"secondary","measure":"Morbidity rates","time_frame":"30 days"},{"outcome_type":"primary","measure":"Postoperative hospital stays","time_frame":"1 month","description":"Days from surgery to discharge"}]}
{"nct_id":"NCT03219983","start_date":"2016-11-30","phase":"Phase 4","enrollment":22,"brief_title":"Pain Management After Total Shoulder Arthroplasty","official_title":"Pain Management After Total Shoulder Arthroplasty: Continuous Interscalene Block Versus Local Tissue Infiltration With Liposomal Bupivacaine","primary_completion_date":"2017-06-30","study_type":"Interventional","rec_status":"Terminated","completion_date":"2017-09-30","last_update":"2017-11-06","description":"The purpose of the study is to determine if pain management after total shoulder arthroplasty is more efficacious with ultrasound guided, continuous Interscalene block or with local tissue infiltration with liposomal bupivacaine. Traditionally, general anesthesia followed by narcotics has been the primary management of pain control. However, regional anesthesia in the form of an interscalene block (ISB), a perineural local anesthetic infusion, is commonly used and may more effectively control pain during and after shoulder arthroplasty, with fewer side effects than narcotics. Intraoperative benefits include better control of blood pressure and reduced need for general anesthesia and narcotics. Depending on the type of block (single shot vs. continuous) and the type of local anesthetic administered, pain relief may persist for 12-96 hours postoperatively. However, not all patients are candidates for peripheral nerve blocks. Pre-existing pulmonary disease, previous neck surgery, cervical arthritis, neurologic disorders and obesity may preclude ISB placement. As well, interscalene blocks are not completely benign procedures. Systemic complications include clinically significant intraoperative hypotension, pneumothorax, vascular injury, cardiac arrest, respiratory failure, seizure and death. Phrenic nerve paralysis is common, although transient. Peripheral nerve injuries related to mechanical injury, medication neurotoxicity, compression or ischemia are infrequent but may be devastating. The experience and number of blocks performed by the anesthesiologist in addition to adjunctive tools, such as ultrasound and/or nerve stimulators, impacts the success of the procedure. Continuous indwelling interscalene blocks (CISB) may provide substantial and longer pain relief, precluding the need for perioperative narcotics. Earlier discharge post procedure and better early range of motion are other purported benefits. However, premature catheter failure, catheter breakage, infection, over administration of medication and extended diaphragmatic paresis are concerns. In addition, there is a cost associated with these procedures. The anesthesiologist fee, catheter with or without elastomeric pump, local anesthetic, perioperative patient evaluation and treatment of any associated complications all must be considered. . The development of new, long acting local anesthetics, such as liposomal bupivacaine, is potentially important in the management of perioperative pain. Liposomal bupivacaine has been approved by the US Food and Drug Administration for local infiltration for pain relief after bunionectomy and hemorrhoidectomy. This preparation increases the duration of local anesthetic action by slow release from the liposome and delays the peak plasma concentration when compared to plain bupivacaine administration. Studies have shown it to be an effective tool for postoperative pain relief with opioid sparing effects and it has also been found to have an acceptable adverse effect profile.","other_id":"Total Shoulder","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patients must be between 18-75 years of age.\r\n\r\n          2. Patients must be candidates for primary total shoulder arthroplasty or reverse total\r\n             shoulder arthroplasty.\r\n\r\n          3. Patients are determined by the investigator to be suitable candidates.\r\n\r\n          4. Patients must be able to understand and comply with protocol procedures.\r\n\r\n          5. Surgery must be performed at The Christ hospital Joint and Spine Center.\r\n\r\n          6. Patients must have BMI < 40 kg/m2\r\n\r\n          7. Patients must weigh a minimum of 50 kg.\r\n\r\n          8. Patients must have an American Society of Anesthesiologists(ASA) physical status I to\r\n             III.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Shoulder arthroplasty performed for an acute proximal humerus fracture.\r\n\r\n          2. Allergy or intolerance to Bupivacaine or ropivacaine.\r\n\r\n          3. Allergy to study medications: midazolam, fentanyl, hydromorphone, or oxycodone.\r\n\r\n          4. History of chronic pain, chronic narcotic use or allergy to narcotics.\r\n\r\n          5. Previous neck surgery or other anatomic abnormalities which would preclude\r\n             interscalene block.\r\n\r\n          6. Failure of interscalene block placement.\r\n\r\n          7. Patients with end-stage hepatic disease.\r\n\r\n          8. Patients with end-stage renal disease requiring dialysis.\r\n\r\n          9. Patients who are pregnant.\r\n      ","sponsor":"The Christ Hospital","sponsor_type":"Other","conditions":"Glenohumeral Arthritis|Total Shoulder Arthroplasty","interventions":[{"intervention_type":"Drug","name":"Drug: Ropivacaine","description":"Patients will have an interscalene block under ultrasound guidance and receive .5% ropivacaine pre-operatively. Upon arrival to the Post-Operative Care Unit a continuous infusion of .5% ropivacaine will be started at 8ml/hr and increased by 2ml/hr every 15 minutes for pain score > 4 with a maximum rate of 14ml/hr. Infusion will be delivered by ON-Q Select-a-Flow pump (volume 750ml)"},{"intervention_type":"Drug","name":"Drug: liposomal bupivacaine","description":"A total injection volume of 100ml will be comprised of 60ml 0.9% normal saline+ 20ml .5% bupivacaine + 20ml liposomal bupivacaine will be administered into the deep tissue of the operative are with an 18 or 20 gauge needle."}],"outcomes":[{"outcome_type":"primary","measure":"NPRS-11 Pain Scores","time_frame":"Pre-Operatively","description":"The Numeric Pain Rating Scale(NPRS) is an 11 point scale with 0 being no pain and 10 being extreme pain. Patients select a value that is most in line with the intensity of pain that they have experienced."},{"outcome_type":"primary","measure":"NPRS-11 Pain Scores","time_frame":"Upon Arrival to PACU through discharge from PACU up to 4 hours.","description":"The Numeric Pain Rating Scale(NPRS) is an 11 point scale with 0 being no pain and 10 being extreme pain. Patients select a value that is most in line with the intensity of pain that they have experienced. Every 15 minutes while in the Post Anesthesia Recovery Unit (PACU)"},{"outcome_type":"primary","measure":"NPRS-11 Pain Scores","time_frame":"Upon arrival to the Patient Care Unit through Hospital Discharge up to 3 days.","description":"The Numeric Pain Rating Scale(NPRS) is an 11 point scale with 0 being no pain and 10 being extreme pain. Patients select a value that is most in line with the intensity of pain that they have experienced every 4 hours while in the Post-Operative patient Unit."},{"outcome_type":"primary","measure":"NPRS-11 Pain Scores","time_frame":"Pain scores will be recorded twice a day from hospital discharge until Post-Operative Day 7.","description":"The Numeric Pain Rating Scale(NPRS) is an 11 point scale with 0 being no pain and 10 being extreme pain. Patients select a value that is most in line with the intensity of pain that they have experienced."},{"outcome_type":"secondary","measure":"Narcotic utilization","time_frame":"Daily through Day 7 post-op","description":"Collected in morphine sulfate equivalents"},{"outcome_type":"secondary","measure":"Length of Stay","time_frame":"From Arrival to PACU through discharge form PACU up to 4 hours.","description":"Collected in hourly time increments"},{"outcome_type":"secondary","measure":"Length of Stay","time_frame":"From Hospital admission until hospital discharge up to 3 days.","description":"The amount of time the patient spent in the hospital in hourly increments."},{"outcome_type":"secondary","measure":"Discharge Status","time_frame":"Upon patient discharge from the hospital up to 3 days.","description":"Will patient be discharged home or to a Skilled Nursing Facility"},{"outcome_type":"secondary","measure":"Procedure Cost","time_frame":"Through hospitalization, generally 3 days","description":"Record the cost of the interscalene block procedure and medication versus the cost of the liposomal bupivacaine injection."},{"outcome_type":"secondary","measure":"Range of Motion","time_frame":"2 weeks, 6 weeks, and 12 weeks postoperatively","description":"This exam will include active and passive elevation, active and passive external rotation, active and passive abduction and internal rotation."},{"outcome_type":"secondary","measure":"Neurovascular Status","time_frame":"2weeks, 6 weeks, and 12 weeks post-operatively","description":"This exam will evaluate motor function and sensation of the operative limb."}]}
{"nct_id":"NCT02886065","start_date":"2016-11-30","phase":"Phase 1","enrollment":20,"brief_title":"A Study of PVX-410, a Cancer Vaccine, and Citarinostat +/- Lenalidomide for Smoldering MM","official_title":"A Phase 1b Study of PVX-410, a Multi-Peptide Cancer Vaccine, and Citarinostat (CC-96241), a Histone Deacetylase Inhibitor (HDAC) With and Without Lenalidomide for Patients With Smoldering Multiple Myeloma","primary_completion_date":"2022-05-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-05-31","last_update":"2021-02-24","description":"This research study is studying a targeted therapy as a possible treatment for Smoldering Multiple Myeloma. The following intervention will be involved in this study: - Lenalidomide - Citarinostat (CC-96241) - PVX-410","other_id":"16-237","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patient has confirmed SMM according to a definition derived from the International\r\n             Myeloma Working Group (IMWG) definition (International Working Group, 2003): serum\r\n             M-protein 3 g/dL or BMPC >10%, or both, along with normal organ and marrow function\r\n             (CRAB) within 4 weeks before baseline.\r\n\r\n               -  C: Absence of hypercalcemia, evidenced by a calcium <10.5 mg/dL.\r\n\r\n               -  R: Absence of renal failure, evidenced by a creatinine < 1.5 mg/dL (177 mol/L)\r\n                  or calculated creatinine clearance (using the Modification of Diet in Renal\r\n                  Disease [MDRD] formula) >50 mL/min.\r\n\r\n               -  A: Absence of anemia, evidenced by a hemoglobin >10 g/dL.\r\n\r\n               -  B: Absence of lytic bone lesions on standard skeletal survey.\r\n\r\n          -  Patient is at higher than average risk of progression to active MM, defined as having\r\n             2 or more of the following features:\r\n\r\n               -  Serum M-protein 3 g/dL.\r\n\r\n               -  BMPC >10%.\r\n\r\n               -  Abnormal serum FLC ratio (0.26-1.65).\r\n\r\n          -  Patient is aged 18 years or older.\r\n\r\n          -  Patient has a life expectancy of greater than 6 months.\r\n\r\n          -  Patient is HLA-A2+\r\n\r\n          -  Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\r\n\r\n          -  Patient has adequate bone marrow function, evidenced by a platelet count 75109/L and\r\n             an absolute neutrophil count (ANC) 1.0109/L within 2 weeks before baseline.\r\n\r\n          -  Patient has adequate hepatic function, evidenced by a bilirubin 2.0 mg/dL and an\r\n             alanine transaminase (ALT), and aspartate transaminase (AST) 2.5ULN within 2 weeks\r\n             before baseline.\r\n\r\n          -  If of child-bearing potential, patient agrees to use adequate birth control measures\r\n             during study participation.\r\n\r\n          -  If a female of child-bearing potential , patient has negative serum pregnancy test\r\n             results within 2 weeks before baseline and is not lactating.\r\n\r\n          -  If assigned to receive lenalidomide and a female of reproductive potential, must\r\n             adhere to the scheduled pregnancy testing as required in the Revlimid REMS program.\r\n\r\n          -  If assigned to receive lenalidomide, patient must be registered into the mandatory\r\n             Revlimid REMS program and be willing and able to comply with the requirements of the\r\n             REMS program.\r\n\r\n          -  Patient (or his or her legally accepted representative) has provided written informed\r\n             consent to participate in the study.\r\n\r\n          -  Patient is willing and able to comply with the protocol for the duration of the study\r\n             including undergoing treatment and scheduled visits and examinations including follow\r\n             up.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patient has symptomatic MM, as defined by any of the following:\r\n\r\n               -  Lytic lesions or pathologic fractures.\r\n\r\n               -  Anemia (hemoglobin <10 g/dL).\r\n\r\n               -  Hypercalcemia (corrected serum calcium > 11.5 mg/dL).\r\n\r\n               -  Renal insufficiency (creatinine > 1.5 mg/dL).\r\n\r\n               -  Other: symptomatic hyperviscosity, amyloidosis.\r\n\r\n          -  Patient has a history of a prior malignancy within the past 3 years (excluding\r\n             resected basal cell carcinoma of the skin or in situ cervical cancer).\r\n\r\n          -  Patient has abnormal cardiac status, evidenced by any of the following:\r\n\r\n               -  New York Heart Association (NYHA) stage III or IV congestive heart failure (CHF).\r\n\r\n               -  Myocardial infarction within the previous 6 months.\r\n\r\n               -  Symptomatic cardiac arrhythmia requiring treatment or persisting despite\r\n                  treatment.\r\n\r\n          -  Patient is receiving any other investigational agent.\r\n\r\n          -  Patient has a current active infectious disease or positive serology for human\r\n             immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV), or\r\n             hepatitis A virus (HAV).\r\n\r\n          -  Patient has a history of or current auto-immune disease.\r\n\r\n          -  Patient has been vaccinated with live attenuated vaccines within 4 weeks before study\r\n             vaccination.\r\n\r\n          -  Any previous treatment with a HDAC inhibitor, including Citarinostat.\r\n\r\n          -  Had involvement in the planning and/or conduct of the study by association with the\r\n             Sponsor, study drug supplier(s) or study center or was previously enrolled in the\r\n             present study.\r\n\r\n          -  Current or prior use of immunosuppressive medication within 28 days before the first\r\n             dose of treatment, with the exceptions of intranasal and inhaled corticosteroids or\r\n             systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of\r\n             prednisone, or an equivalent corticosteroid.\r\n\r\n          -  Mean QT interval corrected for heart rate (QTc) 470 ms calculated from 3\r\n             electrocardiograms (ECGs) using Frediricia's Correction.\r\n\r\n          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active\r\n             infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable\r\n             angina pectoris, active peptic ulcer disease or gastritis, active bleeding diatheses,\r\n             or psychiatric illness/social situations that would limit compliance with study\r\n             requirements or compromise the ability of the patient to give written informed consent\r\n\r\n          -  Known history of previous clinical diagnosis of tuberculosis.\r\n      ","sponsor":"Massachusetts General Hospital","sponsor_type":"Other","conditions":"Smoldering Multiple Myeloma","interventions":[{"intervention_type":"Drug","name":"Drug: Hiltonol","description":"Intramuscular injection of Hiltonol (1 mg) administered Biweekly at the time of PVX-410 administration"},{"intervention_type":"Drug","name":"Drug: Citarinostat","description":"Citarinostat (180 mg) administered orally once daily on days 1-21 every 28 day cycle."},{"intervention_type":"Drug","name":"Drug: Lenalidomide","description":"Lenalidomide (25 mg) administered orally once daily on days 1-21 every 28 day cycle."},{"intervention_type":"Biological","name":"Biological: PVX-410","description":"PVX-410 Biweekly (0.8 mg) via subcutaneous injection"}],"outcomes":[{"outcome_type":"primary","measure":"Safety And Tolerability Of The PVX-410 Tumor Vaccine Regimen","time_frame":"2 years","description":"The proportion of participants who experience dose limiting toxicities and other toxicities. The CTCAE version 4 criteria will be used to grade adverse events."},{"outcome_type":"secondary","measure":"Immune Responses Of Lymphocytes To HLA A2+","time_frame":"2 years"},{"outcome_type":"secondary","measure":"Change In Monoclonal (M) Serum Protein","time_frame":"2 years"},{"outcome_type":"secondary","measure":"Change In Free Light Chain (FLC)","time_frame":"2 years"},{"outcome_type":"secondary","measure":"Change In Urinary FLC Level","time_frame":"2 years"},{"outcome_type":"secondary","measure":"Correlation of Immune Response and Clinical Anti-tumor Responses","time_frame":"2 years"}]}
{"nct_id":"NCT03157674","start_date":"2016-11-24","enrollment":43994,"brief_title":"Real-World Evidence and Treatment Patterns: Head and Neck Cancer","official_title":"Real-World Evidence and Treatment Patterns: Head and Neck Cancer","primary_completion_date":"2018-12-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2018-12-31","last_update":"2018-07-09","description":"This study will be focused on HNC patients who have been diagnosed with HNC between 01-Jan-2013 and 30-Sep-2016.","other_id":"CA209-868","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients in the Medical Data Vision (MDV) database with a HNC diagnosis will be used to\r\n        identify eligible subjects by applying the patient inclusion and exclusion criteria.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  HNC or undefined histology (not otherwise specified [NOS]) HNC diagnosis from\r\n             01-Jan-2013 to 30-Sep-2016 using Japanese disease code\r\n\r\n          -  Age 18 years or older at initial diagnosis of HNC regardless of staging\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Diagnosis of another malignancy on or before the initial diagnosis of HNC with the\r\n             exception of non-melanoma skin cancer and metastatic cancer\r\n\r\n          -  Diagnosis of HNC before 01-Jan 2013 or after 30-Sep-2016\r\n      ","sponsor":"Bristol-Myers Squibb","sponsor_type":"Industry","conditions":"Head & Neck Cancer","interventions":[{"intervention_type":"Other","name":"Other: Non-Interventional","description":"Non-Interventional"}],"outcomes":[{"outcome_type":"primary","measure":"Proportion of patients receiving radiotherapy as anti-cancer treatment","time_frame":"Approximately 45 months"},{"outcome_type":"primary","measure":"Proportion of patients receiving surgery as anti-cancer treatment","time_frame":"Approximately 45 months"},{"outcome_type":"primary","measure":"Proportion of patients receiving chemotherapy as anti-cancer treatment","time_frame":"Approximately 45 months"},{"outcome_type":"primary","measure":"Proportion of patients receiving targeted therapy as anti-cancer treatment","time_frame":"Approximately 45 months"},{"outcome_type":"primary","measure":"Proportion of patients receiving supportive care as anti-cancer treatment","time_frame":"Approximately 45 months"},{"outcome_type":"primary","measure":"Distribution of Treatment History in Head and Neck Cancer (HNC) patients","time_frame":"Approximately 45 months"},{"outcome_type":"secondary","measure":"Distribution of overall survival (OS) by age","time_frame":"Approximately 45 months"},{"outcome_type":"secondary","measure":"Distribution of overall survival (OS) by gender","time_frame":"Approximately 45 months"},{"outcome_type":"secondary","measure":"Distribution of overall survival (OS) by stage","time_frame":"Approximately 45 months"},{"outcome_type":"secondary","measure":"Distribution of overall survival (OS) by tumor site","time_frame":"Approximately 45 months"},{"outcome_type":"secondary","measure":"Distribution of overall survival (OS) by treatment regimen","time_frame":"Approximately 45 months"},{"outcome_type":"secondary","measure":"Number of treatment-limiting adverse events (AEs)","time_frame":"Approximately 45 months","description":"Incidence of important treatment-limiting adverse events (AEs) associated with systemic therapies"},{"outcome_type":"secondary","measure":"Number of withdrawals due to AEs","time_frame":"Approximately 45 months"},{"outcome_type":"secondary","measure":"Proportion of diagnosis of another malignancy on or before the initial diagnosis of HNC","time_frame":"At Baseline"}]}
{"nct_id":"NCT03110549","start_date":"2016-11-21","phase":"Phase 1","enrollment":9,"brief_title":"Study of the Safety, Tolerability and Pharmacokinetics of TMB-607 in HIV-Negative Volunteers","official_title":"A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Sequential Single Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of Subcutaneously and Intramuscularly Administered TMB-607 in HIV-Negative Volunteers","primary_completion_date":"2019-07-22","study_type":"Interventional","rec_status":"Terminated","completion_date":"2019-07-22","last_update":"2020-05-12","description":"The study is a Phase 1, randomized, double-blinded, placebo-controlled, sequential single dose escalation safety, tolerability and pharmacokinetic study of subcutaneous and intramuscular TMB-607 administered to HIV-negative volunteers.","other_id":"TMB 607 101","allocation":"Randomized","intervention_model":"Sequential Assignment","primary_purpose":"Treatment","masking_description":"Triple","intervention_model_description":"Five qualifying participants will be enrolled into each of seven dosage Arms - three escalating subcutaneous dosages (Cohort 1), and four escalating intramuscular dosages (Cohort 2). Enrolling participants will be randomized to receive active TMB-607 or placebo. Beginning with the lowest dosage group, a Data Safety Monitoring Board (DSMB) will review available data after four participants have completed two weeks of post-dose follow-up to determine whether escalation to the next dosage group may proceed","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Participants must meet all of the following criteria to be included in the study:\r\n\r\n               1. Male or female between 18-55 years of age on the day of screening\r\n\r\n               2. HIV-negative volunteers, willing to undergo HIV testing and counseling, and\r\n                  receive HIV test results\r\n\r\n               3. Normal 12-lead ECG at Screening and on Day 0, including normal sinus rate and\r\n                  rhythm, QTc interval 440msec, PR interval 200msec, and lack of any evidence of\r\n                  heart block, or left or right bundle branch block\r\n\r\n               4. Willing to comply with the requirements of the protocol and available for\r\n                  follow-up for the planned duration of the study\r\n\r\n               5. In the opinion of the principal investigator or designee, has understood the\r\n                  information provided; written informed consent needs to be given before any\r\n                  study-related procedures are performed\r\n\r\n               6. Agrees to use a barrier form of contraception if engaging in sexual activity at\r\n                  any time throughout the study (males and females) - two reliable forms of barrier\r\n                  contraception diaphragm, Intra Uterine Device (IUD), spermicides or condoms) must\r\n                  be used if participants engage in sexual activity that could result in pregnancy;\r\n                  hormonal contraception (e.g., oral contraceptive pill, injectable or implantable\r\n                  contraceptive) must not be relied upon while in this study; all female\r\n                  participants must be willing to undergo urine pregnancy tests at time points\r\n                  indicated in the Schedule of Events and Procedures\r\n\r\n               7. For females of reproductive potential, negative urine pregnancy test at screening\r\n                  and within 96 hours prior to randomization; female participants of reproductive\r\n                  potential are defined as women who have not been post-menopausal for at least 24\r\n                  consecutive months (i.e., who have had menses within the preceding 24 months) or\r\n                  have not undergone surgical sterilization (e.g., hysterectomy, or bilateral\r\n                  oophorectomy, salpingectomy, or tubal ligation)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Participants having or meeting any of the following conditions or characteristics will\r\n             be excluded from the study:\r\n\r\n               1. Confirmed HIV-1 or HIV-2 infection\r\n\r\n               2. Currently pregnant or breastfeeding\r\n\r\n               3. Known allergy/sensitivity or any hypersensitivity to components of study drug or\r\n                  its formulation, or known allergy to sulfonamide drugs\r\n\r\n               4. History, or family history of Short of Long QT syndrome, Wolff-Parkinson-White\r\n                  Syndrome, or congenital heart disease\r\n\r\n               5. Family history of sudden cardiac death, or unexplained cardiac death in an\r\n                  otherwise healthy individual between the ages of 1 and 40 years\r\n\r\n               6. History of syncope, palpitations, unexplained dizziness, hypokalemia, heart\r\n                  arrhythmias, or significant cardiac disease\r\n\r\n               7. Major psychiatric illness including any history of schizophrenia or severe\r\n                  psychosis, bipolar disorder requiring therapy, suicide attempt in the previous 3\r\n                  years\r\n\r\n               8. Serious illness requiring systemic treatment and/or hospitalization within 21\r\n                  days prior to randomization\r\n\r\n               9. Receipt of immunomodulatory agents (e.g., interleukins, interferons,\r\n                  cyclosporine, systemic corticosteroids), HIV vaccine, systemic cytotoxic\r\n                  chemotherapy, or investigational therapy within 180 days prior to study entry\r\n\r\n              10. Any clinically significant acute or chronic medical condition requiring care of a\r\n                  physician (e.g., diabetes, coronary artery disease, rheumatologic illness,\r\n                  malignancy, substance abuse) that in the opinion of the investigator would\r\n                  preclude participation\r\n\r\n              11. Any laboratory value of Grade 1 or higher according to the NCI Common Toxicity\r\n                  Criteria (Appendix A)\r\n\r\n              12. Confirmed diagnosis of hepatitis B (surface antigen, HbsAg), or hepatitis C (HCV\r\n                  antibodies)\r\n\r\n              13. Current confirmed STD infection\r\n\r\n              14. In the opinion of the investigator, unlikely to comply with protocol\r\n      ","sponsor":"TaiMed Biologics Inc.","sponsor_type":"Industry","conditions":"Human Immunodeficiency Virus","interventions":[{"intervention_type":"Drug","name":"Drug: TMB-607"},{"intervention_type":"Drug","name":"Drug: Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"TMB 607 plasma concentrations","time_frame":"10 Weeks Post Injection","description":"Measurements of concentrations of TMB-607 in plasma will be used to determine the concentration-time profile of subcutaneous and intramuscular TMB-607 in all participants. TMB-607 plasma concentrations will be measured by a central lab using high-performance liquid chromatography - mass (HPLC-MS) method validated for the measurement of TMB-607 in human plasma."},{"outcome_type":"secondary","measure":"Adverse Events Related to Treatment","time_frame":"10 Weeks Post Injection","description":"The frequency of adverse events will be tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) term and system organ class. The maximum intensity and frequency of adverse events will be summarized by treatment group"}]}
{"nct_id":"NCT03416166","start_date":"2016-11-01","enrollment":269,"brief_title":"International Multisite Transcatheter Tricuspid Valve Therapies Registry","official_title":"International Multisite Transcatheter Tricuspid Valve Therapies Registry","primary_completion_date":"2017-05-15","study_type":"Observational [Patient Registry]","rec_status":"Recruiting","completion_date":"2026-11-01","last_update":"2018-01-30","description":"For a long time, tricuspid valve disease has been considered as less important than left-sided valvular heart disease. If treated in an advanced stage and simultaneously with other cardiac diseases, it is associated with significant morbidity and mortality. Hence, physicians tend to refer patients more aggressively to surgery (1). Transcatheter procedures are an attractive alternative in high-risk patients. The field of transcatheter tricuspid devices has rapidly advanced over the last few years (2). Limited knowledge is available regarding the epidemiologic and anatomical settings in which these therapies are preferentially applied. The main purpose of this registry is the collection of baseline clinical and anatomical data of the patients treated with transcatheter tricuspid valve therapies, and their outcomes, whenever feasible. Apart from more knowledge regarding the current status in this field, the results could also help the establishment of guidelines with respect to the choice of the transcatheter device selected and to understand which therapy can provide the better outcome in the different anatomies. Moreover, this study will provide important information about the epidemiology of severe tricuspid regurgitation, which is at the moment an undertreated disease.","other_id":"2016-01753","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":99,"population":"Patients with severe symptomatic tricuspid regurgitation","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  All the patients undergoing transcatheter tricuspid valve intervention.\r\n\r\n        General inclusion criteria:\r\n\r\n          -  Minimal age: 18 years\r\n\r\n          -  Patient is able to give written informed consent to the procedure\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients not fulfilling the indications for transcatheter tricuspid intervention\r\n      ","sponsor":"University of Zurich","sponsor_type":"Other","conditions":"Severe Tricuspid Regurgitation","interventions":[{"intervention_type":"Device","name":"Device: Transcatheter Tricuspid Intervention","description":"Any available transcatheter tricuspid valve intervention"}],"outcomes":[{"outcome_type":"primary","measure":"Cardiovascular Death","time_frame":"30 days"},{"outcome_type":"secondary","measure":"NYHA Class","time_frame":"30 days, 1 year"},{"outcome_type":"secondary","measure":"TR Reduction","time_frame":"30 days, 1 year"}]}
{"nct_id":"NCT03441672","start_date":"2016-11-01","phase":"N/A","enrollment":79,"brief_title":"Game-Based Decision Aid to Educate Pregnant Women About Prenatal Screening","official_title":"Improved Prenatal Genetic Screening Decision Making Through Interactive Technology","primary_completion_date":"2017-03-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-03-30","last_update":"2018-02-26","description":"Significant barriers exist for effectively informing women about prenatal screening in the clinical setting. This project developed and evaluated the efficacy of a game decision aid among pregnant women about prenatal screening in a randomized controlled study.","other_id":"R21HD083832","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  English speaking\r\n\r\n          -  less than 15 weeks gestation\r\n\r\n          -  attending first obstetric visit\r\n\r\n          -  low risk pregnancy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Non-English speaking\r\n\r\n          -  High risk pregnancy\r\n\r\n          -  Past 15 weeks gestation\r\n      ","sponsor":"University of Utah","sponsor_type":"Other","conditions":"Prenatal Disorder","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Meaning of Screening","description":"Interactive technology game providing education about prenatal screening and what the results may mean."}],"outcomes":[{"outcome_type":"primary","measure":"Level of knowledge about prenatal screening and prenatal diagnostic testing","time_frame":"Immediately after intervention","description":"prenatal screening knowledge is measured with a 23-item survey developed by an expert panel of genetic counselors, physicians, social scientists and data collection experts. All questions use a five point likert scale for response."},{"outcome_type":"secondary","measure":"Documentation of decision to undergo prenatal screening","time_frame":"Up to 4 weeks after intervention","description":"Documentation of participant's decision to complete prenatal screening or not, as pulled from the medical record."}]}
{"nct_id":"NCT03534869","start_date":"2016-11-01","phase":"Phase 3","enrollment":60,"brief_title":"Auricular Acupuncture as Effective Pain Relief After Episiotomy","official_title":"Auricular Acupuncture as Effective Pain Relief After Episiotomy: A Prospective Interventional Randomized Parallel Single-center Study","primary_completion_date":"2017-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-04-30","last_update":"2018-05-23","description":"Background: Episiotomy is performed in up to 30% of vaginal deliveries. Previously, pain treatment following episiotomy has relied on non-steroid anti-inflammatory drugs (NSAID) as analgesics, whose use during breastfeeding remains controversial due of their transfer to the child through lactation. The aim of the study is to determine the effect of acupuncture on postpartal perineal pain following episiotomy. Methods: The study is designed as a prospective interventional randomized parallel single-center study to evaluate the effects of auricular acupuncture on pain relief after episiotomy. The population will encompass 60 patients that have had mediolateral episiotomy performed during vaginal delivery, with 29 receiving acupuncture therapy and 31 not receiving acupuncture therapy for pain relief. NSAID analgesic therapy will be made available per request.","other_id":"14280 / 16-4","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"The study was designed as a prospective interventional randomized parallel longitudinal single-center study to evaluate the effects of auricular acupuncture on pain relief after episiotomy conducted in the Department of Gynecology and Obstetrics, University Hospital Center Sestre milosrdnice, Zagreb, Croatia. Prospective data were collected from November 2016 to April 2017. The study included healthy pregnant women over 18 years of age, a minimum of 36 weeks gestation that underwent mediolateral episiotomy during vaginal delivery. Sixty patients were included in the study. The patients were allocated either of the groups by using a heads-tails binary result coin toss method. Twenty-nine patients were treated with auricular acupuncture for episiotomy pain relief combined with oral analgesic therapy per request, while 31 patients were treated with oral analgesics per request only. In both groups, administration of oral analgesics was recorded.","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  healthy pregnant women over 18 years of age\r\n\r\n          -  a minimum of 36 weeks' gestation\r\n\r\n          -  patients that underwent mediolateral episiotomy during vaginal delivery\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  any illness diagnosed during pregnancy\r\n\r\n          -  unwillingness to submit to acupuncture therapy\r\n      ","sponsor":"University Hospital \"Sestre Milosrdnice\"","sponsor_type":"Other","conditions":"Acupuncture, Ear|Episiotomy; Complications|Pain, Labor","interventions":[{"intervention_type":"Procedure","name":"Procedure: Ear acupuncture","description":"French auriculotherapy guidelines - internal genital area, external genital area and Shen Men point."},{"intervention_type":"Drug","name":"Drug: Analgesics","description":"Oral ibuprofen was given as first line therapy, while oral paracetamol was given as second line therapy."}],"outcomes":[{"outcome_type":"primary","measure":"Pain relief","time_frame":"Immediately after birth, 2 hours after birth, during the first 3 days-at rest and activity.","description":"Level of pain intensity measured by VAS - Visual Analogue Scale score ranging from 1 (smallest pain level) to 10 (highest pain level)."},{"outcome_type":"secondary","measure":"Oral analgesics amount","time_frame":"First 3 postpartal days.","description":"Amount of given analgesics in miligrams per patient per day during the first 3 postpartal days."},{"outcome_type":"secondary","measure":"Postpartum bleeding and pain due to uterine contractions","time_frame":"First 3 postpartal days.","description":"Subjective levels of postpartum bleeding and pain due to uterine contractions recorded."},{"outcome_type":"secondary","measure":"Number of analgesic repetitions during the day.","time_frame":"First 3 postpartal days.","description":"Number of times patients required oral analgesic therapy (N)."}]}
{"nct_id":"NCT02935959","start_date":"2016-10-31","phase":"Phase 1/Phase 2","enrollment":90,"brief_title":"Premedication With Nebulized Ketamine,Dexmedetomidine Versus Midazolam in Oncologic Preschool Children","official_title":"Premedication With Different Nebulized Ketamine,Dexmedetomidine Versus Midazolam in Oncologic Preschool Children","primary_completion_date":"2017-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-10-31","last_update":"2018-01-12","description":"Evaluate the efficacy of nebulized dexmedetomidine, nebulized ketamine, and nebulized midazolam a premedication prior to general anesthesia (GA) in oncologic preschool children undergo bone marrow aspirate and biopsy.","other_id":"349","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":3,"maximum_age":7,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  physical status I and II, scheduled for bone marrow aspirate and biopsy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  known allergy to the studied drugs,\r\n\r\n          -  organ dysfunction,\r\n\r\n          -  cardiac dysrrhythmia and/or congenital heart disease,\r\n\r\n          -  psychotropic medication use and mental retardation\r\n      ","sponsor":"Assiut University","sponsor_type":"Other","conditions":"Oncological Children","interventions":[{"intervention_type":"Drug","name":"Drug: nebulized ketamine","description":"Drugs will be prepared in 3 mL of saline 0.9% before administration by a standard hospital jet nebulizer via a mouthpiece, with a continuous flow of 100% oxygen at 6 L/min for 10 to 15 minutes (30 minutes before GA). Treatment will be stopped when the nebulizer began to sputter."},{"intervention_type":"Drug","name":"Drug: nebulized Dexmedetomidine"},{"intervention_type":"Drug","name":"Drug: nebulized midazolam"}],"outcomes":[{"outcome_type":"primary","measure":"the degree of sedation when the child was first seen in the OR","time_frame":"30 minutes after sedation","description":"measure the degree of sedation using using a 5 point sedation scale. Sedation level: Agitated =1, alert= 2, calm= 3, drowsy = 4, asleep=5."},{"outcome_type":"secondary","measure":"parental separation","time_frame":"30 min after sedation","description":"The parental separation anxiety scale (PSAS)"},{"outcome_type":"secondary","measure":"Emergecy agitation","time_frame":"30 min after induction","description":"Emergence agitation will be assessed according to a 3-point scale: 1 = calm; 2 = restless but calms to verbal instructions; and 3 = combative and disoriented."}]}
{"nct_id":"NCT02938221","start_date":"2016-10-31","phase":"N/A","enrollment":30,"brief_title":"Telemedical Examination of a Three-Component Oculomotor Testing Battery","official_title":"Feasibility and Safety of a Telemedically Performed Three-Component Oculomotor Testing Battery (HINTS) in Healthy Adults","primary_completion_date":"2016-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-12-31","last_update":"2017-01-12","description":"The study investigates the feasibility and safety of the telemedical implementation of three diagnostic oculomotor tests using a video-oculography device and an extended teleconferencing system. The testing battery comprises Halmagyi's head impulse test, test for nystagmus and test of skew (vertical misalignment) known as the HINTS protocol. Previously published data have shown high sensitivity and specificity of the protocol for the discrimination of central and peripheral causes of acute vestibular syndrome. In this study the three tests will be executed on 30 healthy subjects using video goggles (EyeSeeCam, Interacoustics GmbH, Germany) connected to a mobile wireless-workstation for bidirectional audiovisual communication in a clinical environment (MEYTEC GmbH, Germany). A newly developed remote control and video conferencing solution allows the execution and evaluation of the HINTS protocol in a telemedical setup. The examination is guided by a remote physician using the help of a trained assistant attending to the subject. Corresponding clinical bedside tests will be executed for comparison. Primary endpoint is feasibility of the three diagnostic tests in a telemedical setting. Safety as well as accuracy of the telemedical versus bedside examination will be analyzed as secondary outcome measures. Aim of the study is to improve diagnostic accuracy for patients with acute vestibular syndrome in remote areas where specialists are rare.","other_id":"TeleHINTS-1","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Consenting adults\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Acute vertigo or dizziness, acute neck pain, history of stroke, history of acute\r\n             vestibular syndrome, strong unilateral or bilateral visual impairment, complete\r\n             movement restriction of cervical spine\r\n      ","sponsor":"Munich Municipal Hospital","sponsor_type":"Other","conditions":"Stroke|Vertigo|Dizziness","interventions":[{"intervention_type":"Device","name":"Device: Telemedical video-oculography system","description":"Telemedical video-oculography setup consisting of video goggles (EyeSeeCam, Interacoustics GmbH, Germany), a mobile telemedical workstation and an extended conferencing and remote control system (MEYTEC GmbH, Germany)"}],"outcomes":[{"outcome_type":"secondary","measure":"Time delay of telemedical tests","time_frame":"through completion of diagnostic test, an average of 10 minutes"},{"outcome_type":"primary","measure":"Number of evaluable telemedical oculomotor examinations","time_frame":"through completion of diagnostic test, an average of 10 minutes"},{"outcome_type":"secondary","measure":"Accuracy of telemedical oculomotor examination (correlation to bedside test)","time_frame":"through completion of diagnostic test, an average of 10 minutes"},{"outcome_type":"secondary","measure":"Number of participants with adverse or serious adverse events that are related to telemedical oculomotor examination","time_frame":"through completion of diagnostic test, an average of 10 minutes"}]}
{"nct_id":"NCT02461758","start_date":"2016-10-31","phase":"Phase 4","enrollment":81,"brief_title":"Trial of High Dose vs. Standard Dose Influenza Vaccine in Inflammatory Bowel Disease Patients","official_title":"Randomized Trial of High Dose vs. Standard Dose Influenza Vaccine in Inflammatory Bowel Disease Patients","primary_completion_date":"2018-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-07-31","last_update":"2019-10-02","description":"Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal tract which includes Crohn's disease (CD) and ulcerative colitis (UC). A recent epidemiological investigation estimates that nearly 4 million people worldwide are affected and approximately 1.4 million of these cases occur in the United States. IBD can lead to debilitating symptoms, hospitalizations, decreased quality of life, frequent procedures and/or surgery. Treatment options consist of immunosuppressive therapy, such as systemic corticosteroids, immunomodulators (thiopurines and methotrexate) and/or biologics, such as tumor necrosis factor alpha (TNF) agents or an integrin inhibitor, vedolizumab. They can achieve clinical remission and decrease the risk of complications, but also increase the risk for opportunistic infections, including influenza. Multiple studies have shown lower influenza vaccine responses in patients with IBD compared to healthy individuals; IBD patients treated with TNF agents or combination therapy (TNF inhibitors and immunomodulators) are very likely to mount a poor immune response. Influenza serum antibody concentration correlates with protection from infection following vaccination. Therefore, increasing influenza antibody responses in patients with IBD would appear to be critical to improving protection from influenza. A high dose (HD) influenza vaccine containing four times more hemagglutinin was licensed based on its ability to induce higher antibody concentrations compared to standard dose (SD) in adults 65 years or older.","other_id":"2015-0813","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":64,"population":"","criteria":"\n        CASES Specific Aim #1 Inclusion Criteria\r\n\r\n          -  A history of chronic (greater than 3 month) ulcerative colitis or Crohn's disease\r\n             diagnosed and documented by the standard clinical, radiographic, endoscopic and\r\n             histopathologic criteria.\r\n\r\n          -  Ages 18-64\r\n\r\n          -  Currently taking anti-TNF therapy (infliximab, golilumab, adalimumab, or certolizumab)\r\n             for at least 3 months\r\n\r\n          -  Exclusion Criteria\r\n\r\n          -  Received season's influenza vaccine\r\n\r\n          -  Allergy to eggs or influenza vaccine\r\n\r\n          -  Currently use of systemic steroids in the past 3 months\r\n\r\n        Specific Aim #2 Inclusion criteria\r\n\r\n          -  A history of chronic (greater than 3 month) ulcerative colitis or Crohn's disease\r\n             diagnosed and documented by the standard clinical, radiographic, endoscopic and\r\n             histopathologic criteria.\r\n\r\n          -  Ages 18-64\r\n\r\n          -  Currently on vedolizumab therapy\r\n\r\n        Exclusion Criteria\r\n\r\n          -  Received season's influenza vaccine\r\n\r\n          -  Allergy to eggs or influenza vaccine\r\n\r\n          -  Currently use of systemic steroids in the past 3 months\r\n\r\n        Control group Inclusion criteria\r\n\r\n          -  Age 18-64\r\n\r\n          -  Willing to participate in study\r\n\r\n        Control group Exclusion criteria\r\n\r\n          -  Currently on immunosuppressive therapy\r\n\r\n          -  Has a chronic health condition that may have an impact on vaccine antibody\r\n             concentrations as deemed by the investigators, including chronic liver disease, celiac\r\n             disease, history of solid organ or bone marrow transplantation.\r\n\r\n          -  Older than age 65 years\r\n\r\n          -  Unconfirmed Measles, Mumps, and Rubella (MMR) vaccination status\r\n\r\n          -  Patients in whom venipuncture are not feasible due to poor tolerability or lack of\r\n             easy access.\r\n      ","sponsor":"University of Wisconsin, Madison","sponsor_type":"Other","conditions":"Inflammatory Bowel Disease (IBD)","interventions":[{"intervention_type":"Biological","name":"Biological: Standard dose Influenza vaccine (SDIV)"},{"intervention_type":"Biological","name":"Biological: High dose influenza vaccine (HDIV)"}],"outcomes":[{"outcome_type":"secondary","measure":"Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization","time_frame":"4 weeks","description":"Seroprotection is defined as an antibody concentration of at least 1:40 at 4 weeks post-immunization which confers protection from infection in about 50% of individuals"},{"outcome_type":"secondary","measure":"Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization","time_frame":"4 weeks","description":"Seroprotection is defined by the FDA as post-immunization concentration of 1:160 that confers protection from infection to 95% of the population."},{"outcome_type":"primary","measure":"Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine","time_frame":"Pre-immunization and 2-4 weeks post immunization","description":"Influenza vaccine antibody concentration will be measured in immunosuppressed IBD patients who receive high dose and standard of care dose influenza vaccine.\r\nHigher antibody concentrations are associated with better protection from infection."},{"outcome_type":"secondary","measure":"Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion","time_frame":"4 weeks","description":"Vaccine response rates for influenza vaccines in patients with inflammatory bowel disease will be accessed by number of patients who has shown significant seroconversion. Seroconversion is defined as a four fold increase in antibody concentration from preimmunization to 4 weeks post immunization."},{"outcome_type":"secondary","measure":"Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine","time_frame":"6 months post-immunization","description":"Influenza vaccine antibody concentration will be measured in immunosuppressed IBD patients who receive high dose and standard of care dose influenza vaccine.\r\nHigher antibody concentrations are associated with better protection from infection."}]}
{"nct_id":"NCT02834767","start_date":"2016-10-31","phase":"N/A","enrollment":23,"brief_title":"Genioglossus Muscle Training for Snoring and Obstructive Sleep Apnea","official_title":"Genioglossus Muscle Training for Snoring and Obstructive Sleep Apnea","primary_completion_date":"2019-05-04","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-05-04","last_update":"2020-02-06","description":"Obstructive sleep apnea (OSA) carries serious health consequences for patients. Evidence exists that some behavioral (e.g. exercise based) therapies may assist in lessening the severity of this disorder. The proposed investigation will examine the effects of eight weeks of genioglossus muscle strength training on measures of snoring and OSA severity as well as genioglossus protrusive muscle strength.","other_id":"IRB201600916","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Device Feasibility","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":90,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Snoring + AHI < 5/hr (primary snoring group)\r\n\r\n          -  AHI  5/hour and less than 30/hour (OSA group)\r\n\r\n          -  Ability to understand and perform training.\r\n\r\n          -  Ability to return to the UF Health Sleep Center 1X per week for the (8 week) duration\r\n             of the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnancy\r\n\r\n          -  Prior Upper airway surgery (nasal surgery is allowed)\r\n\r\n          -  Severe nasal obstruction\r\n\r\n          -  BMI > 40 kg/M2\r\n\r\n          -  Use of CPAP > 12 cm H2O *\r\n\r\n          -  Use of potent narcotics\r\n\r\n          -  History of arrhythmia (other than PACs and PVCs)\r\n\r\n          -  Coronary artery disease or congestive heart failure (patients with controlled\r\n             hypertension will be included),\r\n\r\n          -  Moderate to severe lung disease\r\n\r\n          -  History of pneumothorax.\r\n\r\n          -  severe daytime sleepiness (falling asleep while driving or Epworth Sleepiness Scale >\r\n             14),\r\n\r\n          -  History of chronic short sleep duration (< 5 hours).\r\n      ","sponsor":"University of Florida","sponsor_type":"Other","conditions":"Snoring|Sleep Apnea, Obstructive","interventions":[{"intervention_type":"Device","name":"Device: Genioglossis Strength Trainer","description":"The genioglossis strength trainer is a handheld device, manufactured in house, consisting of an outer tube, inner piston, and pressure loaded spring. The device can be set to a specific pressure resistance ranging from 10 to 40 Newtons. Users press against the inner piston with their tongues until the piston moves approximately 1/2 centimeter (and the inner pressure loaded spring depresses approximately 1/2 centimeter)."},{"intervention_type":"Device","name":"Device: Placebo Genioglossis Strength Trainer","description":"The placebo genioglossis strength trainer is a handheld device, manufactured in house, consisting of an outer tube, inner piston, and pressure loaded spring. Whereas the pressure loaded spring in the active trainer can be set to a wide range of pressures, the placebo trainer has a maximum resistance of 5 Newtons. The device is set to a specific pressure resistance of 5 Newtons at all times. Users press against the inner piston with their tongues until the piston moves approximately 1/2 centimeter (and the inner pressure loaded spring depresses approximately 1/2 centimeter)."}],"outcomes":[{"outcome_type":"secondary","measure":"Snoring Severity","time_frame":"Pre to post treatment (approximately 10 weeks)","description":"Snoring sensor recording snoring frequency and amplitude during sleep"},{"outcome_type":"secondary","measure":"Apnea-Hypopnea Index","time_frame":"Pre to post treatment (approximately 10 weeks)","description":"Episodes of apnea and/or hypopnea scored during the course of sleep study"},{"outcome_type":"primary","measure":"Maximum Tongue Pressure Force (MTPF)","time_frame":"Pre to post treatment (approximately 10 weeks)","description":"Maximum pressure generated (in Newtons) during tongue protrusion"}]}
{"nct_id":"NCT02906605","start_date":"2016-10-31","phase":"Phase 2","enrollment":0,"brief_title":"A Study of the Clinical Activity and Safety of JNJ-64041809, a Live Attenuated Listeria Monocytogenes Immunotherapy, in Combination With Apalutamide Versus Apalutamide in Subjects With Metastatic Castration-resistant Prostate Cancer","official_title":"An Open-label, Randomized, Phase 2 Study of the Clinical Activity and Safety of JNJ-64041809, a Live Attenuated Listeria Monocytogenes Immunotherapy, in Combination With Apalutamide Versus Apalutamide in Subjects With Metastatic Castration-resistant Prostate Cancer","primary_completion_date":"2018-09-30","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2018-09-30","last_update":"2016-11-22","description":"The purpose of this study is to evaluate if the anti-tumor activity of JNJ-809 combined with apalutamide is improved compared with apalutamide alone for subjects with metastatic castration-resistant prostate cancer (mCRPC).","other_id":"CR108224","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adenocarcinoma of the prostate\r\n\r\n          -  Metastatic disease as documented by technetium-99m (99mTc) bone scan or metastatic\r\n             lesions by computed tomography (CT) or magnetic resonance imaging (MRI) scans\r\n\r\n          -  Surgically or medically castrated, with testosterone levels of less than (<)50\r\n             nanogram per deciliter (ng/dL)\r\n\r\n          -  Castration-resistant prostate cancer documented by time to prostate-specific antigen\r\n             (PSA) increase during continuous treatment with androgen deprivation therapy (ADT) OR\r\n             radiographic progression of soft tissues OR radiographic progression of bone according\r\n             to PCWG3\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Predominately small cell or neuroendocrine carcinoma of the prostate\r\n\r\n          -  Known brain metastases (even if treated) or untreated epidural spread\r\n\r\n          -  Prior chemotherapy for prostate cancer, except if administered in the\r\n             adjuvant/neoadjuvant setting, or up to 6 cycles of docetaxel for metastatic\r\n             hormone-sensitive prostate cancer\r\n\r\n          -  Treatment with medications known to lower the seizure threshold or any investigational\r\n             agent that were not discontinued or substituted greater than or equal to (>=)28 days\r\n             prior to randomization\r\n      ","sponsor":"Janssen Research & Development, LLC","sponsor_type":"Industry","conditions":"Prostatic Neoplasms, Castration-Resistant","interventions":[{"intervention_type":"Drug","name":"Drug: JNJ-809","description":"JNJ-809 (1*10^9) colony forming units (CFU) given as an infusion."},{"intervention_type":"Drug","name":"Drug: Apalutamide","description":"Apalutamide 240 mg orally daily."}],"outcomes":[{"outcome_type":"primary","measure":"Time to Prostate-specific Antigen (PSA) Progression","time_frame":"approximately 2 years","description":"Time to PSA progression will be measured using Prostate Cancer Working Group 3 (PCWG3)."},{"outcome_type":"secondary","measure":"PSA Doubling Time (PSADT)","time_frame":"approximately 2 years","description":"The PSADT will be determined using the method as recommended by PCWG3 criteria."},{"outcome_type":"secondary","measure":"Radiographic Progression-free Survival","time_frame":"approximately 2 years","description":"Radiographic progression-free survival, is defined as the time from the date of randomization to the date of radiographic progression or death, whichever occurs first."},{"outcome_type":"secondary","measure":"Time to Unequivocal Clinical Progression","time_frame":"approximately 2 years","description":"Time to unequivocal clinical progression defined as the time from the date of randomization to the date of unequivocal clinical progression as evaluated by the investigator."},{"outcome_type":"secondary","measure":"Overall Survival","time_frame":"approximately 2 years","description":"Overall survival defined as time from the date of randomization to death from any cause."},{"outcome_type":"secondary","measure":"Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability","time_frame":"approximately 2 years","description":"Comparison of the AE profiles of the two treatment groups."},{"outcome_type":"secondary","measure":"Blood Culture and Shedding Profile of JNJ-809 From Cultured Samples of Feces, Urine, and Saliva","time_frame":"approximately 2 years","description":"Blood culture samples will be collected after the mandatory prophylactic antibiotic therapy. Bacterial shedding will be evaluated from cultured samples of feces by stool or rectal swab, urine, and sputum."}]}
{"nct_id":"NCT02943187","start_date":"2016-10-31","phase":"N/A","enrollment":5,"brief_title":"Multidisciplinary Intervention for Mild Cognitive Impairment","official_title":"Novel Functional Medicine Intervention With Cognitive Training for Mild Cognitive Impairment (MCI): A Multiple Baseline Study Across Cases","primary_completion_date":"2018-12-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2022-06-30","last_update":"2021-07-27","description":"The purpose of this investigation is to conduct a series of case studies on the impact of a novel functional medicine approach to improving cognitive skills, brain structure, and daily functioning for participants with Mild Cognitive Impairment (MCI).","other_id":"GICR-1012","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":50,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age 50+ previously diagnosed with MCI\r\n\r\n          -  Living in the greater Colorado Springs area\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  No braces, metal implants, or claustrophobia that would contraindicate magnetic\r\n             resonance imaging\r\n      ","sponsor":"Gibson Institute of Cognitive Research","sponsor_type":"Industry","conditions":"Mild Cognitive Impairment","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Cognitive training","description":"A clinician will deliver three 90-minute cognitive training sessions per week for 14 weeks. There are 16 different categories of leveled training procedures sequenced in intensity and difficulty for a total of 530 training tasks."},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Nutrition","description":"Participants will be given dietary recommendations and nutritional supplements to optimize cognition."}],"outcomes":[{"outcome_type":"primary","measure":"Evidence of overall cognitive function improvement","time_frame":"within 14 days after completing the intervention","description":"Confirmed by change in pretest to post-test scores on the Dementia Rating Scale (DRS-2)"},{"outcome_type":"secondary","measure":"Evidence of improvement in executive function","time_frame":"within 14 days after completing the intervention","description":"As confirmed by pretest to post-test changes on the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)"},{"outcome_type":"secondary","measure":"Evidence of improvement in cognitive flexibility","time_frame":"within 14 days after completing the intervention","description":"As confirmed by pretest to post-test changes on a Trail Making Test"},{"outcome_type":"secondary","measure":"Evidence of change in brain function","time_frame":"within 30 days after completing the intervention","description":"Confirmed by change in pretest to post-test neuroimaging using MRI"},{"outcome_type":"secondary","measure":"Evidence of improvement in visual attention","time_frame":"with 14 days after completing the intervention","description":"Confirmed by change in pretest to post-test scores on the Conners Continous Performance Test (CPT-3)"},{"outcome_type":"secondary","measure":"Evidence of improvement in auditory attention","time_frame":"with 14 days after completing the intervention","description":"Confirmed by change in pretest to post-test scores on the Auditory Attention Test (CATA)"}]}
{"nct_id":"NCT02235090","start_date":"2016-10-31","phase":"N/A","enrollment":0,"brief_title":"Study of Feasibility to Reliably Measure Functional Abilities' Changes in Nonambulant Neuromuscular Patients Without Trial Site Visiting","official_title":"Assessment of Feasibility and Statistical Reliability of Functional Outcomes Measurement in Neuromuscular Patients Without Trial Site Visiting by Standard Functional Scales and by Special Autonomic Device in Double-blind, Placebo Controlled Study of Cervical Spinal Cord Transdermal Direct Current Stimulation in Patients With Spinal Muscular Atrophy","primary_completion_date":"2017-09-30","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2017-10-30","last_update":"2019-02-15","description":"Clinical trials organization in several neuromuscular disorders (NMD) has some specific issues. Nonambulant status and difficulties with transportation are among them. Moreover a lot of patients with NMD have so poor condition that even short transportation is able to worse it. Such situation forces researchers to limit a region of recruitment for clinical trials and to exclude from trials more severe subgroup of patients, which cause additional issues especially for rare diseases. The purpose of this study is to prove hypothesis about possibility to reliably monitor patient condition remotely, without trial site visiting. Visit-free study design is potentially able to widen eligible patient population and to decrease patient dropout rate as well as burden of numerous assessments. Meanwhile assessment frequency could be increased enabling monitoring of short fluctuations in patients' condition. Spinal muscular atrophy (SMA) is a rare neuromuscular condition to which all mentioned above issues are completely applicable. Direct current stimulation (DCS) of neural structures is well studied and safe intervention, however, its effects on SMA patients' strength and durability has not been reported for today. The investigators suppose that investigation of DCS action in SMA patient population is an adequate model for visit-free design feasibility, reliability and sensitivity evaluation.","other_id":"CSMA-INPN-1","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":5,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Signed informed consent\r\n\r\n          -  5q SMA confirmed by molecular testing\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Need for ventilation\r\n\r\n          -  Hypersensitivity (pain or allergic reaction) to current stimulation\r\n      ","sponsor":"Charitable Foundation Children with Spinal Muscular Atrophy","sponsor_type":"Other","conditions":"Spinal Muscular Atrophy|Neuromuscular Disorders","interventions":[{"intervention_type":"Other","name":"Other: Direct current stimulation of cervical spinal cord","description":"10 minutes direct current stimulation of 0, 100 microamperes, 1 milliampere strengths applied through dermal electrodes to cervical spinal cord"}],"outcomes":[{"outcome_type":"primary","measure":"Strength Changes from baseline measured by handheld myometry after spinal cord direct current stimulation of different intensity","time_frame":"Before and 0, 15, 30 minutes after spinal cord direct current stimulation"},{"outcome_type":"secondary","measure":"Short time fluctuations of Hammersmith Functional Motor Scale indexes","time_frame":"Three times, three days consecutive measurement, every two months, assessed up to 6 months"}]}
{"nct_id":"NCT02947828","start_date":"2016-10-31","enrollment":490,"brief_title":"Polyneuropathy in Diabetes Mellitus Type 2","official_title":"Polyneuropathy in Diabetes Mellitus Type 2","primary_completion_date":"2018-11-30","study_type":"Observational","rec_status":"Completed","completion_date":"2018-12-31","last_update":"2019-02-08","description":"This is a population-based study of type 2 diabetes patients with and without neuropathy recruited from the Danish National Type 2 Diabetes cohort (DD2). Perspective: The study will identify risk factors for developing diabetic polyneuropathy and painful diabetic polyneuropathy and provide information on the underlying mechanisms, which will hopefully contribute to significant improvements in the treatment and prevention of diabetic polyneuropathy in future.","other_id":"IDNC-DD2-NP","observational_model":"Case-Control","time_perspective":"Cross-Sectional","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"Type 2 diabetes patients","criteria":"\n        Inclusion Criteria T2D patients:\r\n\r\n          -  Clinical diagnosis of type 2 diabetes\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnancy\r\n\r\n          -  Poor or no Danish language skills\r\n\r\n          -  Insufficient mental capacity to provide informed consent or complete questionnaires\r\n\r\n        Additional criteria for healthy controls:\r\n\r\n          -  Any neurological or psychiatric disorder\r\n\r\n          -  Chronic pain\r\n\r\n          -  Severe illness\r\n\r\n          -  Pain treatment 3 days before the examination\r\n      ","sponsor":"Danish Pain Research Center","sponsor_type":"Other","conditions":"Diabetes Mellitus Type 2 Without Complication|Polyneuropathies, Diabetic|Diabetes Complications|Diabetic Peripheral Neuropathy|Chronic Pain","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Presence of diabetic polyneuropathy","time_frame":"5 hours","description":"For case definition of neuropathy, Tesfaye et al. 2010 will be used."},{"outcome_type":"primary","measure":"Presence of painful diabetic polyneuropathy","time_frame":"5 hours","description":"Neuropathic pain grading system. Finnerup et al. 2016 will be used."}]}
{"nct_id":"NCT03463967","start_date":"2016-10-31","phase":"N/A","enrollment":61,"brief_title":"Effects of Tomato Products in Children With NAFLD","official_title":"Controlled Trial on the Effect of Tomato Products in Obese Children With Non Alcoholic Fatty Liver Disease","primary_completion_date":"2018-02-28","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2018-06-30","last_update":"2018-03-13","description":"CONTROLLED TRIAL ON THE EFFECT OF TOMATO PRODUCTS IN OBESE CHILDREN WITH NON ALCOHOLIC FATTY LIVER DISEASE Aim of the study To evaluate the effect of the addition of a daily dose of lycopene enriched tomato sauce on the progress of NAFDL in obese children. Participants Children with obesity referred to the Hepatology unit of Dept.of Pediatric Clinic of the University Federico II of Naples. Diagnosis of NAFLD is made on the presence of fatty liver at ultrasound examination, with or without hypertransaminasemia. Patients are eligible on the basis of: - Age 4-14 years - BMI > 85percentile - Liver Steatosis evaluated as mild, moderate or severe by US (hyperechogenic liver tissue compared with the adjacent kidney cortex) Patients are excluded on the basis of: - Liver disease - Diabetes or manifest metabolic alterations - Associated diseases Informed consent is obtained from the parents of the participating children. Sample size estimation To provide an 80% power to detect a 25% or greater relative shift of outcome variables, with a first degree error of .05 a sample of 50 cases is estimated in a cross over trial. Study design This is a randomized, crossover, one side open trial with blinded outcome evaluation. A statistician who is not otherwise involved in the trial generated the randomized assignment sequence. At the enrollment all participants received a low carotenoids diet for two weeks (wash out), then children are assigned to the first intervention for 8 weeks, and subsequently, in the crossover phase, they are switched to the second intervention for the next 8 weeks. No wash out is planned between the two treatments. Interventions 1. Supplemented diet: 100 gr/day of Lycopene enriched tomato products (weekly average) 2. Control diet: ordinary healthy diet, with no special encouragement to eat carotenes products All children are put on a 'mediterranean style' diet, with a controlled amount of calories: a dedicated dietitian for the whole study, irrespective of the treatment, checked their diet twice a week. At beginning (T0) and at the end of each treatment (T1 and T2) all patients underwent anthropomorphic measurements, including weight, height, waist, abdomen and hips circumferences. BMI and its standard deviation score are calculated. Regardless of group assignment, all participants are seen by a hepatologist at the end of each intervention and checked for liver steatosis, by US. Fasting blood samples are collected at beginning (T0) and at the end of each treatment (T1 and T2) to evaluate IR (assessed by HOMA), transaminases levels, lipids profile, oxidative state (assessed by antioxidant enzymes activity, serum levels of MDA and carbonylated proteins), inflammatory state (by cytokines serum levels, typing of lymphocytes subpopulations, metabolism of lymphocytes). Data collection are performed in a partially blind fashion: the statistician performing data analysis is blind to treatment. Outcomes: The primary outcome is reduction of the liver steatosis estimated by US Scan, according to the following parameters: parenchyma echogenicity (compared with that of the cortical of the right kidney), far gain attenuation, diaphragm blurring. steatosis. Secondary outcomes is reduction in Insulin resistance, Oxidative state, Inflammatory state. Statistical Analysis Data are inspected for normality and paired t-test (before/after) of each phase of the trial are performed when appropriate. The Median % change of each variable between the values at Time 8 and 16 weeks and values at enrollment are also looked. Ordinal logistic regression analysis, hierarchical, mixed model with adjustment variables are adopted to estimate the size of the effect. The study is approved by the Ethical Committee of University Federico II of Naples.","other_id":"TD1016","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":4,"maximum_age":14,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age 4-14 years\r\n\r\n          -  BMI > 85percentile\r\n\r\n          -  Liver Steatosis evaluated as mild, moderate or severe by US (hyperechogenic liver\r\n             tissue compared with the adjacent kidney cortex)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Liver diseases\r\n\r\n          -  Diabetes or manifest metabolic alterations\r\n\r\n          -  Associated diseases\r\n      ","sponsor":"Federico II University","sponsor_type":"Other","conditions":"NAFLD","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Lycopene-enriched tomato juice","description":"Energy-restricted diet supplemented with Lycopene-enriched tomato juice"},{"intervention_type":"Other","name":"Other: Energy-restricted diet"}],"outcomes":[{"outcome_type":"primary","measure":"Reduction of liver steatosis","time_frame":"Baseline and 16 weeks","description":"The presence and severity of liver steatosis are graded by using the following criteria:\r\n2. The presence of hyperechogenic liver tissue (compared with the adjacent kidney cortex) with fine and tightly packed echo targets and of normal beam penetration with normal visualization of diaphragm and portal vein borders is considered as mild steatosis.\r\n3. The moderate and diffuse increase of echo intensity with decreased beam penetration (with slightly decreased visualization of diaphragm) associated with a decrease in visualization of silhouetting of the portal vein borders is considered as moderate steatosis.\r\n4. The marked increase in echoes intensity with no visualization of portal vein border, obscured diaphragm and posterior portion of the right lobe, and reduced visibility of kidney is considered as severe steatosis."},{"outcome_type":"primary","measure":"Reduction in BMI","time_frame":"Baseline and 16 weeks","description":"Standard methods of evaluation"},{"outcome_type":"secondary","measure":"Reduction in ALT serum level","time_frame":"Baseline and 16 weeks","description":"Standard method of evaluation"},{"outcome_type":"secondary","measure":"Improvement of inflammatory state","time_frame":"Baseline and 16 weeks","description":"Evaluation of serum levels of standard markers of inflammation (CRP, ferritin); cytokines profiling, lymphocyte typing"},{"outcome_type":"secondary","measure":"Amelioration of oxidative state","time_frame":"Baseline and 16 weeks","description":"Evaluation of activity of serum antioxidant enzymes and markers of oxidative stress (MDA, Carbonylate proteins, oxidized LDL)"}]}
{"nct_id":"NCT02999139","start_date":"2016-10-13","enrollment":3000,"brief_title":"Analytic, Prospective Cohort Study of Athletes Enrolled in an Exercise Training Intervention","official_title":"Analytic, Prospective Cohort Study of Athletes Enrolled in an Exercise Training Intervention","primary_completion_date":"2025-01-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2026-01-31","last_update":"2020-08-06","description":"Participants who train at The Micheli Center for Sports Injury Prevention, will undergo testing of muscular strength, range of motion, flexibility, aerobic capacity and muscular endurance. They will complete training with a certified trainer and injury prevention specialist until their specific goals are meet. Upon completion of training, they will fill out an injury questionnaire every three months for five to ten years.","other_id":"P00023758","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":6,"population":"Male and females age 6 and over.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Males, Females, age 6 and over\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  younger than 6 years old\r\n      ","sponsor":"Boston Children's Hospital","sponsor_type":"Other","conditions":"Exercise Training","interventions":{},"outcomes":[{"outcome_type":"secondary","measure":"Anaerobic Capacity","time_frame":"Before training and after completion of training at The Micheli Center for Sports Injury Prevention. Training can last from four weeks to a year.","description":"This will be measured by a series of tests such as the vertical jump test and shuttle run. These measures will be tested pre and post training."},{"outcome_type":"secondary","measure":"Range of Motion","time_frame":"Before training and after completion of training at The Micheli Center for Sports Injury Prevention. Training can last from four weeks to a year.","description":"This will be measured by goniometer at different joints such as the knee and ankle pre and post training."},{"outcome_type":"primary","measure":"Injury","time_frame":"After a subject undergoes training at The Micheli Center for Sports Injury Prevention, they will complete a survey every 3 months for the next 10 years.","description":"For purposes of our study, an injury is one that:\r\noccurred as a result of participation in sport AND\r\nrequired medical attention by a team athletic trainer or a physician AND\r\nresulted in restriction of the student-athlete's participation for one or more days beyond the day of injury OR\r\nresulted in any fracture, concussion, or dental injury regardless of whether or not it resulted in restriction of the student-athlete's participation"},{"outcome_type":"secondary","measure":"Training Habits","time_frame":"After a subject undergoes training at The Micheli Center for Sports Injury Prevention, they will complete a survey every 3 months for the next 10 years.","description":"Surveys will answer if participants continue with their new training habits"},{"outcome_type":"secondary","measure":"Muscular Strength","time_frame":"Before training and after completion of training at The Micheli Center for Sports Injury Prevention. Training can last from four weeks to a year.","description":"This will be measured by hand held dynamometer pre and post training intervention. Will testing major muscles such as the quadriceps, hamstrings, biceps, triceps."},{"outcome_type":"secondary","measure":"Aerobic Capacity","time_frame":"Before training and after completion of training at The Micheli Center for Sports Injury Prevention. Training can last from four weeks to a year.","description":"This will be estimated by the step test, done pre and post training."}]}
{"nct_id":"NCT02919969","start_date":"2016-10-11","phase":"Phase 2","enrollment":32,"brief_title":"Pembrolizumab in Metastatic Anal Cancer","official_title":"A Multicenter Phase 2 Clinical Trial of Pembrolizumab in Metastatic Anal Cancer","primary_completion_date":"2022-03-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-03-31","last_update":"2021-05-14","description":"This research study is studying a targeted therapy as a possible treatment for advanced anal cancer. The following intervention will be involved in this study: -Pembrolizumab","other_id":"16-301","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Participants must have metastatic anal cancer that has been histologically confirmed.\r\n\r\n          -  There is no limit to the number of prior therapies.\r\n\r\n          -  Be willing and able to provide written informed consent/assent for the trial.\r\n\r\n          -  Be 18 years of age on day of signing informed consent.\r\n\r\n          -  Have measurable disease based on RECIST 1.1.\r\n\r\n          -  Be willing to provide tissue from a newly obtained core or excisional biopsy of a\r\n             tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days)\r\n             prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples\r\n             cannot be provided (e.g. inaccessible or subject safety concern) may submit an\r\n             archived specimen only upon agreement from the Sponsor.\r\n\r\n          -  Have a performance status of 0 or 1 on the ECOG Performance Scale.\r\n\r\n          -  Demonstrate adequate organ function, all screening labs must be performed within 10\r\n             days of treatment initiation.\r\n\r\n        Adequate Organ Function Laboratory Values\r\n\r\n        System Laboratory Value\r\n\r\n          -  Hematological\r\n\r\n               -  Absolute neutrophil count (ANC) 1,500 /mcL\r\n\r\n               -  Platelets 80,000 / mcL\r\n\r\n               -  Hemoglobin 8.5 g/dL or 5.6 mmol/L\r\n\r\n          -  Renal\r\n\r\n             --Serum creatinine OR Measured or calculated creatinine clearance (GFR can also be\r\n             used in place of creatinine or CrCl) 1.5 X upper limit of normal (ULN) OR 60 mL/min\r\n             for subject with creatinine levels > 1.5 X institutional ULN\r\n\r\n          -  Hepatic\r\n\r\n               -  Serum total bilirubin  1.5 X ULN OR Direct bilirubin  ULN for subjects with\r\n                  total bilirubin levels > 1.5 ULN\r\n\r\n               -  AST (SGOT) and ALT (SGPT)  2.5 X ULN OR  5 X ULN for subjects with liver\r\n                  metastases\r\n\r\n               -  Albumin >2.8 mg/dL\r\n\r\n          -  Coagulation\r\n\r\n               -  International Normalized Ratio (INR) or Prothrombin Time (PT) 1.5 X ULN unless\r\n                  subject is receiving anticoagulant therapy as long as PT or PTT is within\r\n                  therapeutic range of intended use of anticoagulants\r\n\r\n               -  Activated Partial Thromboplastin Time (aPTT) 1.5 X ULN unless subject is\r\n                  receiving anticoagulant therapy as long as PT or PTT is within therapeutic range\r\n                  of intended use of anticoagulants\r\n\r\n          -  Creatinine clearance should be calculated per institutional standard.\r\n\r\n          -  Female subject of childbearing potential must have a negative urine or serum pregnancy\r\n             within 72 hours prior to receiving the first dose of study medication. If the urine\r\n             test is positive or cannot be confirmed as negative, a serum pregnancy test will be\r\n             required.\r\n\r\n          -  Female subjects of childbearing potential must be willing to use 2 methods of birth\r\n             control or be surgically sterile, or abstain from heterosexual activity for the course\r\n             of the study through 120 days after the last dose of study medication (Reference\r\n             Section 7.4). Subjects of childbearing potential are those who have not been\r\n             surgically sterilized or have not been free from menses for > 1 year.\r\n\r\n          -  Male subjects must agree to use an adequate method of contraception starting with the\r\n             first dose of study therapy through 120 days after the last dose of study therapy.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any\r\n             other form of immunosuppressive therapy within 7 days prior to the first dose of trial\r\n             treatment. Subjects requiring systemic steroids are excluded from the trial. The use\r\n             of physiologic doses of corticosteroids may be approved after discussion with the\r\n             sponsor.\r\n\r\n          -  Has a known history of active TB (Bacillus Tuberculosis)\r\n\r\n          -  Hypersensitivity to pembrolizumab or any of its excipients.\r\n\r\n          -  Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study\r\n             Day 1 or who has not recovered (i.e.,  Grade 1 or at baseline) from adverse events\r\n             due to agents administered more than 4 weeks earlier.\r\n\r\n          -  Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy\r\n             within 2 weeks prior to study Day 1 or who has not recovered (i.e.,  Grade 1 or at\r\n             baseline) from adverse events due to a previously administered agent.\r\n\r\n               -  Note: Subjects with  Grade 2 neuropathy and alopecia are an exception to this\r\n                  criterion and may qualify for the study.\r\n\r\n               -  Note: If subject received major surgery, they must wait  3 weeks prior to\r\n                  starting study treatment. They must have recovered adequately from the toxicity\r\n                  and/or complications from the intervention prior to starting therapy.\r\n\r\n          -  Has a known additional malignancy that is progressing or requires active treatment.\r\n             Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the\r\n             skin that has undergone potentially curative therapy or in situ cervical cancer.\r\n\r\n          -  Has known active central nervous system (CNS) metastases and/or carcinomatous\r\n             meningitis. Subjects with previously treated brain metastases may participate provided\r\n             they are stable (without evidence of progression by imaging for at least four weeks\r\n             prior to the first dose of trial treatment and any neurologic symptoms have returned\r\n             to baseline), have no evidence of new or enlarging brain metastases, and are not using\r\n             steroids for at least 7 days prior to trial treatment. This exception does not include\r\n             carcinomatous meningitis which is excluded regardless of clinical stability.\r\n\r\n          -  Has active autoimmune disease that has required systemic treatment in the past 2 years\r\n             (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive\r\n             drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid\r\n             replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a\r\n             form of systemic treatment.\r\n\r\n          -  Has an active infection requiring systemic therapy.\r\n\r\n          -  Patients that require supplemental oxygen are excluded.\r\n\r\n          -  Has a history or current evidence of any condition, therapy, or laboratory abnormality\r\n             that might confound the results of the trial, interfere with the subject's\r\n             participation for the full duration of the trial, or is not in the best interest of\r\n             the subject to participate, in the opinion of the treating investigator.\r\n\r\n          -  Has known psychiatric or substance abuse disorders that would interfere with\r\n             cooperation with the requirements of the trial.\r\n\r\n          -  Is pregnant or breastfeeding, or expecting to conceive or father children within the\r\n             projected duration of the trial, starting with the pre-screening or screening visit\r\n             through 120 days after the last dose of trial treatment.\r\n\r\n          -  Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.\r\n\r\n          -  HIV+ positive patients are eligible if their CD4+ count  300/L and they have an\r\n             undetectable viral load. In addition, they must be currently receiving Highly Active\r\n             Antiretroviral Therapy (HAART) and be under the care of an Infectious Diseases\r\n             specialist.\r\n\r\n          -  Patients with hepatitis B and hepatitis C must be under the care of viral hepatitis\r\n             expert consultant. Patients with hepatitis B are required to be treated with anti-HBV\r\n             treatment (e.g., entecavir). Patients with hepatitis C need to have received prior\r\n             and/or ongoing hepatitis C treatment.\r\n\r\n          -  Has received a live vaccine within 30 days of planned start of study therapy. Note:\r\n             Seasonal influenza vaccines for injection are generally inactivated flu vaccines and\r\n             are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live\r\n             attenuated vaccines, and are not allowed.\r\n\r\n          -  Has a history of (non-infectious) pneumonitis that required steroids or current\r\n             pneumonitis.\r\n      ","sponsor":"Dana-Farber Cancer Institute","sponsor_type":"Other","conditions":"Anal Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Pembrolizumab","description":"Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks."}],"outcomes":[{"outcome_type":"primary","measure":"Overall Response Rate","time_frame":"36 months","description":"Overall response rate of pembrolizumab in metastatic anal cancer patients will be evaluated by RECIST 1.1."},{"outcome_type":"secondary","measure":"PD-L1 Positive Response Rate","time_frame":"36 months","description":"Response rate in PD-L1 positive metastatic anal cancer patients will be evaluated by RECIST 1.1."},{"outcome_type":"secondary","measure":"Overall Survival","time_frame":"36 months","description":"Evaluate the durability of pembrolizumab responses in PD-L1 positive metastatic anal cancer patients by measuring median overall survival."},{"outcome_type":"secondary","measure":"Progression Free Survival","time_frame":"36 months","description":"Evaluate the durability of pembrolizumab responses in PD-L1 positive metastatic anal cancer patients by measuring median progression free survival."},{"outcome_type":"secondary","measure":"Incidence of Adverse Events to Evaluate the Safety and Tolerability of Pembrolizumab","time_frame":"Every 3 Weeks, from the time the informed consent is signed through 90 days following cessation of treatment","description":"Assess how well pembrolizumab is tolerated in patients with metastatic anal cancer by evaluating adverse events by CTCAE v4.0."}]}
{"nct_id":"NCT03830294","start_date":"2016-10-10","phase":"N/A","enrollment":30,"brief_title":"Physical and Psychological Effects of Different Temperature-controlled Breast Prostheses on Patients With Breast Cancer","official_title":"Physical and Psychological Effects of Different Temperature-controlled Breast Prostheses on Patients With Breast Cancer During Rehabilitation: a Randomized Controlled Study","primary_completion_date":"2017-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-06-30","last_update":"2019-02-05","description":"Breast loss causes negative influence on women physically, psychologically and socially. Breast prosthesis can improve patient's figure externally, increase self-confidence, thus improving quality of life. The objective was to understand the knowledge regarding breast prostheses in breast cancer patients, evaluate the quality of life of patients wearing different types of breast prostheses and to compare the physical and psychological effects of different temperature-controlled breast prostheses on patients. The investigators designed a randomized control study in one cancer center in Shanghai. In the first 6 weeks of the study, self-adhesive breast prostheses and conventional breast prostheses were used in the intervention and control group, respectively. In the later 6 weeks, the breast prostheses used were switched into another kind. Several dimensional parameters were examined by different questionnaires at the end of both 6th and 12th week including scars and skin, survey of breast prosthesis knowledge, survey assessing the comfort and practicality of breast prostheses, quality of life instruments for cancer patients and body image scale. The investigators expected that women would be satisfied with the temperature-controlled breast prosthesis and were more willing to choose self-adhesive breast prostheses.","other_id":"IRB1403133-2","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  undergoing unilateral mastectomy due to breast cancer confirmed by histological\r\n             examination\r\n\r\n          -  had undergone mastectomy at least six months prior to the start of the study or\r\n             patients who completed radiation therapy at least two months prior\r\n\r\n          -  without evidence of postoperative relapse\r\n\r\n          -  wearing conventional (non-adhesive) breast prostheses\r\n\r\n          -  without abnormal skin or skin lesions\r\n\r\n          -  patients without progressive lymphedema;\r\n\r\n          -  interested in conventional and self-adhesive breast prostheses.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  with incomplete healing of their surgical wounds\r\n\r\n          -  undergoing chemoradiotherapy or who received chemoradiotherapy less than two months\r\n             prior to the beginning of the study\r\n\r\n          -  with skin conditions that do not meet the requirements\r\n\r\n          -  whose remaining breast is not within the study's size range\r\n\r\n          -  with significant life changes during the study, including divorce, unemployment or\r\n             depression; 6) relapsed during the observation period\r\n\r\n          -  had a reaction to the first skin test and who were not able to receive the second skin\r\n             test.\r\n      ","sponsor":"Fudan University","sponsor_type":"Other","conditions":"External Breast Prostheses","interventions":[{"intervention_type":"Other","name":"Other: different temperature-controlled breast prostheses","description":"Two types of temperature-controlled breast prostheses were applied to patients in each group"}],"outcomes":[{"outcome_type":"primary","measure":"Participants' skin condition","time_frame":"12 weeks","description":"Scars and skin conditions: these examinations were performed by the same investigator."},{"outcome_type":"primary","measure":"Participants' knowledge with regard to the breast prosthesis","time_frame":"12 weeks","description":"A self-designed questionnaire covering a total of 11 items was used, including sources the patients used to obtain information on breast prostheses, reasons for choosing the breast prosthesis, its type and price, and the patient's feelings about wearing their breast prosthesis."},{"outcome_type":"primary","measure":"Participants' feeling of the comfort and practicality of breast prostheses","time_frame":"12 weeks","description":"A self-designed questionnaire covering a total of 10 items regarding the breast prostheses was used, including skin adhesion, practicality in daily life, maintainability, comfort, natural fit, contact, safety, and effects on the shoulder and back"},{"outcome_type":"primary","measure":"Measurement of Quality of life of the participants","time_frame":"12 weeks","description":"We use breast cancer (QLICP-BR) to measure patients' quality of life.the QLICP-BR selected the following 37 items: 6 items in physical functional dimensions (PH), 12 items in psychological functional dimensions (PS), 8 items in symptoms and side effects dimensions (ST), 10 items in social functional dimensions (SOs) and 1 item in overall health condition."},{"outcome_type":"primary","measure":"Measurement of Body Image of the participants","time_frame":"12 weeks","description":"The Body Image Scale (BIS) is a self-assessment scale designed to assess cancer patients' perceptions of their appearance and identify any changes to those perceptions resulting from a disease or a treatment."}]}
{"nct_id":"NCT03102983","start_date":"2016-10-06","phase":"N/A","enrollment":20,"brief_title":"Sensory-motor Interactions in the Perception of Vowels: a Study in Repetition - Suppression","official_title":"Sensory-motor Interactions in the Perception of Vowels: a Study in Repetition - Suppression","primary_completion_date":"2016-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-12-31","last_update":"2018-10-10","description":"The aim of our study is to show by fMRI the involvement of the motor system in the perception of speech, and more particularly how this implication is modulated by the degree of prototypicity of the stimuli.","other_id":"38RC16.026","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Medicall exam before MRI\r\n\r\n          -  Pregnant Women\r\n\r\n          -  Patients aged 18-45 years, Right-handed\r\n\r\n          -  without neurologic and/or psychiatric troubles\r\n\r\n          -  normal audition\r\n\r\n          -  Audition normale\r\n\r\n          -  French mother tongue\r\n\r\n          -  Social security affiliation\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  protected person\r\n\r\n          -  MRI contraindication\r\n\r\n          -  claustrophobia\r\n\r\n          -  respirtaory and cardiovascular pathology\r\n\r\n          -  toxic substances taking\r\n      ","sponsor":"University Hospital, Grenoble","sponsor_type":"Other","conditions":"Healthy","interventions":[{"intervention_type":"Other","name":"Other: MRI functional","description":"vowels records and MRI session"}],"outcomes":[{"outcome_type":"primary","measure":"Evaluate the involvement of the speech motor system in the perception of vowels, using functional magnetic resonance imaging (fMRI).","time_frame":"One hour and forty five minutes","description":"fMRI measured"}]}
{"nct_id":"NCT02792426","start_date":"2016-10-05","phase":"Phase 1","enrollment":34,"brief_title":"Nicotine Pharmacokinetics From Research Electronic Nicotine Delivery System S-TA-U001 in Smokers and E-Cigarette Users","official_title":"A Study to Evaluate the Comparative Pharmacokinetics of Nicotine After Administration Via Research Electronic Nicotine Delivery System S-TA-U001 in Healthy Volunteer Smokers and Current E-Cigarette Users","primary_completion_date":"2017-06-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-06-01","last_update":"2018-05-17","description":"To better understand the PK and associated pharmacodynamic (PD) responses produced by the Research ENDS S-TA-U001 product, this study will compare the Research ENDS S-TA-U001 to - The subject's own brand combustion (non-menthol) cigarette and a U.S. FDA approved smoking cessation product, the NICORETTE Inhalator, in current non-menthol cigarette smokers who have some limited e-cigarette experience (Group 1). - Commercially available products in current primarily e-cigarette users (experienced ENDS users) (Group 2) The PK/PD session for each product will be conducted in a controlled clinical setting with frequent PK sampling after 14 hours of supervised abstinence from all forms of nicotine. Subjects will familiarize themselves with the Research ENDS S-TA-U001 and NICORETTE Inhalator by using each product in the real world for one day before the PK/PD session for that product. Primary Objectives: Group 1 objectives are to characterize the nicotine PK profile (eg, maximum plasma concentration [Cmax], time to maximum plasma concentration [Tmax], area under the concentration-time curve [AUC], and terminal half-life [t1/2]) for 10 inhalation and ad lib sessions of Research ENDS S-TA-U001 and explore how the Cmax compares to a 15 ng/mL level during the 4.5-minute 10 inhalation and the 6 hour ad lib use sessions, to compare the PK profiles between Research ENDS S-TA-U001 to the profiles of combustion cigarettes measured at the baseline session, and to demonstrate superiority of PK profile of Research ENDS S-TA-U001 to that of the marketed NICORETTE Inhalator. Group 2 objectives are to characterize the nicotine PK profile of Research ENDS S-TA-U001 and explore how the Cmax compares to a 15 ng/mL level during the 4.5-minute 10 inhalation and 6 hour ad lib use sessions, and to compare the PK profile between Research ENDS S-TA-U001 to the profile of a commercial ENDS product measured at the baseline session. Secondary objectives: Secondary objectives include comparison of the nicotine PK of the Research ENDS S-TA-U001 to the subjects' normal nicotine source (combustion cigarettes for Group 1 or commercial ENDS for Group 2), to evaluate the safety and tolerability of Research ENDS S-TA-U001, to evaluate the effects on craving and user satisfaction of the Research ENDS S-TA-U001 vs a combustion cigarette or the NICORETTE Inhalator (Group 1) or a commercial ENDS product (Group 2), and to evaluate various biomarkers following use of each test product.","other_id":"NPK016-N44DA","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":21,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        For Group 1: in order to participate in the study, potential subjects must:\r\n\r\n          1. Be males and females of any race between 21 and 65 years of age inclusive\r\n\r\n          2. Be current combustion cigarette smokers, defined as smoking a minimum of 10 combustion\r\n             cigarettes per day for a period of at least 3 months, who smoke commercial (non\r\n             menthol) cigarettes\r\n\r\n          3. Not be currently planning to quit smoking combustion cigarettes in the next 3 months\r\n\r\n          4. Have blood cotinine 100 ng/mL and carbon monoxide 10 ppm at Screening to confirm\r\n             smoking status\r\n\r\n          5. Weigh at least 45 kg and have a Body Mass Index (BMI) between 18 and 40 kg/m2,\r\n             inclusive, at Screening\r\n\r\n          6. Be healthy, in the Investigator's opinion, according to medical history; physical\r\n             examination; electrocardiogram (ECG); and clinical chemistry, urine, and hematological\r\n             laboratory tests\r\n\r\n          7. Be willing to refrain from using any source of nicotine other than study supplies for\r\n             the duration of the study confinement period\r\n\r\n          8. Have vital signs as follows:\r\n\r\n               -  Resting heart rate between 50 and 90 beats per minute\r\n\r\n               -  Systolic blood pressure below 150 mm Hg\r\n\r\n               -  Diastolic blood pressure below 90 mm Hg\r\n\r\n          9. Have electrolytes (ie, Na, K, Cl, HCO3) and hematocrit that are clinically normal (\r\n             10% of laboratory limits); subjects marginally outside of this range may be eligible\r\n             at the discretion of the study physician\r\n\r\n         10. Have liver function tests (ie, total bilirubin, ALT, AST, GGT, and alkaline\r\n             phosphatase) less than three times the upper normal limit\r\n\r\n         11. Have kidney function tests (ie, creatinine and BUN) within clinically normal limits (\r\n             10% of laboratory limits) and calculated creatinine clearance > 80 mL/min for females\r\n             and > 90 mL/min for males\r\n\r\n         12. Have an ECG performed that demonstrates normal sinus rhythm, normal conductivity, and\r\n             no clinically significant abnormalities\r\n\r\n         13. Be able to demonstrate the ability to comply with the inhalation instructions for Test\r\n             Product administration (Research ENDS S TA U001 and NICORETTE Inhalator), visually\r\n             confirmed by clinic staff at Screening visit\r\n\r\n         14. Be able to verbalize understanding of the consent forms, provide written informed\r\n             consent, and verbalize willingness to comply with the study procedure\r\n\r\n         15. Have 5-50 days of use of any ENDS product in their life and no use within 7 days\r\n             before Screening\r\n\r\n         16. Have no more than 20 days of use of the NICOTROL Inhaler in their life and no use\r\n             within the 7 days before Screening\r\n\r\n        For Group 2: in order to participate in the study, potential subjects must:\r\n\r\n          1. Be males and females between 21 and 65 years of age inclusive\r\n\r\n          2. Be current daily users of a commercially available ENDS product, with e-liquids of\r\n             nicotine concentration 10 to 20 mg/mL\r\n\r\n          3. Consume at least 1 mL per day of e-liquid in their ENDS product\r\n\r\n          4. Not smoke more than 2 combustion (non menthol) cigarettes per day\r\n\r\n          5. Have carbon monoxide 15 ppm at Screening to confirm limited smoking status\r\n\r\n          6. Have blood cotinine 100 ng/mL at Screening to confirm nicotine dependence\r\n\r\n          7. Weigh at least 45 kg and have a Body Mass Index (BMI) between 18 and 40 kg/m2,\r\n             inclusive, at screening\r\n\r\n          8. Be healthy, in the Investigator's opinion, according to medical history; physical\r\n             examination; ECG; and clinical chemistry, urine and hematological laboratory tests\r\n\r\n          9. Be willing to refrain from using any source of nicotine for the duration of the study\r\n             confinement period\r\n\r\n         10. Have vital signs as follows:\r\n\r\n               -  Resting heart rate between 50 and 90 beats per minute\r\n\r\n               -  Systolic blood pressure below 150 mm Hg\r\n\r\n               -  Diastolic blood pressure below 90 mm Hg\r\n\r\n         11. Have electrolytes (ie, Na, K, Cl, HCO3) and hematocrit that are clinically normal (\r\n             10% of laboratory limits); subjects marginally outside of this range may be eligible\r\n             at the discretion of the study physician\r\n\r\n         12. Have liver function tests (ie, total bilirubin, ALT, AST, GGT, and alkaline\r\n             phosphatase) less than three times the upper normal limit\r\n\r\n         13. Have kidney function tests (ie, creatinine and BUN) within clinically normal limits (\r\n             10% of laboratory limits) and calculated creatinine clearance > 80 mL/min for females\r\n             and > 90 mL/min for males\r\n\r\n         14. Have an ECG performed that demonstrates normal sinus rhythm, normal conductivity, and\r\n             no clinically significant abnormalities\r\n\r\n         15. Be able to demonstrate the ability to comply with the inhalation instructions for Test\r\n             Product administration (Research ENDS S TA U001), visually confirmed by clinic staff\r\n             at Screening visit\r\n\r\n         16. Be willing to use tobacco-flavored product\r\n\r\n         17. Be able to verbalize understanding of the consent forms, provide written informed\r\n             consent, and verbalize willingness to comply with the study procedure\r\n\r\n        Exclusion Criteria:\r\n\r\n        For Group 1 and Group 2: in order to participate in the study, potential subjects must not:\r\n\r\n          1. Have expected inability to comply with study protocol\r\n\r\n          2. Have used any of the following in the past 30 days: ultra-light, hand or\r\n             roll-your-own, menthol, or unfiltered combustion cigarettes; any other form of tobacco\r\n             (eg, chews, dips, pipes, cigars, hookah); or any form of nicotine replacement therapy\r\n             (eg, patch, gum, lozenge, inhaler, nasal spray).\r\n\r\n          3. Be pregnant (based on serum test) or nursing (by self-report)\r\n\r\n          4. Have history or diagnosis of airway disease, including adult onset asthma or chronic\r\n             obstructive pulmonary disease (including emphysema or chronic bronchitis), use of an\r\n             inhaler (apart from a nicotine inhaler) in the previous 5 years, or any episodes of\r\n             wheezing or bronchospasm in the previous 5 years (history of resolved childhood asthma\r\n             is acceptable)\r\n\r\n          5. Have baseline spirometry values (FEV1, FVC, and FEV1/FVC) outside of the lower limit\r\n             of normal as defined by Hankinson et al, Am J Respir Crit Care Med 1999; 159:179-187.\r\n\r\n          6. Have had treatment with prescription medications within 21 days or over-the-counter\r\n             medication within 24 hours of the planned first product use occasion, except for oral\r\n             or hormonal contraceptive therapies.\r\n\r\n          7. Have used any drugs or substances (except tobacco) known to be strong inducers or\r\n             inhibitors of any CYP enzymes (formerly known as cytochrome P450 enzymes) within a 28\r\n             days period prior to first product administration. For a list of such drugs and\r\n             substances, please refer to http://medicine.iupui.edu/clinpharm/ddis/main-table/.\r\n\r\n          8. Have an active cough, recent or chronic, excluding \"smoker's cough\"\r\n\r\n          9. Have any active respiratory infection\r\n\r\n         10. Have a history of clinically significant cardiac, pulmonary, renal, hepatic,\r\n             endocrine, neurological, gastrointestinal, metabolic, psychiatric, or hematologic\r\n             disorders\r\n\r\n         11. Have poor venous access as defined by being unable to draw samples through a catheter\r\n             at the screening visit\r\n\r\n         12. Have been hospitalized within 4 weeks before Screening\r\n\r\n         13. Have received any other investigational treatment or Test Product within 30 days from\r\n             randomization (or within 5 half-lives of the Test Product, if known, whichever is\r\n             greater)\r\n\r\n         14. Have a history of allergic, anaphylactic, or other hypersensitivity reaction to any e\r\n             cigarette , or any of the components associated with these products such as propylene\r\n             glycol\r\n\r\n         15. Have any medical history or condition (including physical) considered by the Principal\r\n             Investigator and/or admitting physician to place the subjects at increased risk or\r\n             preclude safe and/or successful completion of the study\r\n\r\n         16. Have any history of substance abuse, including alcohol abuse within the last 3 months\r\n\r\n         17. Have a positive result for any drug of abuse (opiates, benzodiazepines, barbiturates\r\n             or related CNS depressants, amphetamines or related stimulants, or marijuana) at\r\n             screening or Day -1\r\n\r\n         18. Be cognitively impaired to a degree that would affect participation. An adequate level\r\n             of reading and comprehension is needed in order to complete various forms (e.g.,\r\n             behavioural assessments) that are used as dependent variables\r\n\r\n         19. Have active syphilis (based on the standard confirmatory test (e.g., FTB-abs))\r\n\r\n         20. Be undergoing HIV treatment with antiviral and non-antiviral therapy or treatment for\r\n             HIV-related opportunistic infection\r\n\r\n         21. Do not actively meet the inclusion criteria at the time of screening\r\n      ","sponsor":"NJOY, Inc.","sponsor_type":"Industry","conditions":"Cigarette Smoking","interventions":[{"intervention_type":"Drug","name":"Drug: Research ENDS S-TA-U001"},{"intervention_type":"Drug","name":"Drug: Nicorette Inhalator"}],"outcomes":[{"outcome_type":"primary","measure":"Nicotine Cmax","time_frame":"~5 minutes before administration and at 1, 3, 5, 7, 10, 15, 30, 60, 90, 120, 130, 140, 150, 180, 210, 240, 300, 360, 420, and 480 minutes from start of each administration","description":"Characterize nicotine Cmax of all test products during a 10-puff 4.5-minute session and a 6 hour ad lib use session and compare to a target level of 15 ng/mL"},{"outcome_type":"primary","measure":"Nicotine AUC","time_frame":"~5 minutes before administration and at 1, 3, 5, 7, 10, 15, 30, 60, 90, 120, 130, 140, 150, 180, 210, 240, 300, 360, 420, and 480 minutes from start of each administration","description":"Characterize nicotine AUC from time 0 to the last time point for all test products"},{"outcome_type":"primary","measure":"Nicotine tmax","time_frame":"~5 minutes before administration and at 1, 3, 5, 7, 10, 15, 30, 60, 90, 120, 130, 140, 150, 180, 210, 240, 300, 360, 420, and 480 minutes from start of each administration","description":"Characterize the time when the maximum nicotine concentration is reached for all test products during a 10-puff 4.5-minute session and a 6 hour ad lib use session"},{"outcome_type":"secondary","measure":"Adverse events and vital signs","time_frame":"5 days","description":"To evaluate the safety and tolerability of Research ENDS S TA U001 during 4.5-minute 10 inhalation and 6 hour ad lib use sessions. Vital signs include respiratory rate, blood pressure, and oral temperature."},{"outcome_type":"secondary","measure":"Effects on craving","time_frame":"5 days","description":"To evaluate the effects on craving of the Research ENDS S TA U001 versus (vs) a combustion cigarette or the NICORETTE Inhalator (combustion cigarette users) or a commercial ENDS product (e cigarette users). A 5-item Questionnaire of Smoking Urges will be administered at -3, 2.75, 7, 20, 40, 65, 118, 125, 155, 185, 215, 275, 335, 395, and 455 minutes after the first puff of each test product administration."},{"outcome_type":"secondary","measure":"Effects on user satisfaction","time_frame":"5 days","description":"To evaluate the effects on user satisfaction of the Research ENDS S TA U001 versus (vs) a combustion cigarette or the NICORETTE Inhalator (combustion cigarette users) or a commercial ENDS product (e cigarette users). A likeability survey will be administered at the end of the in-clinic session for each test product"},{"outcome_type":"secondary","measure":"White blood cell count","time_frame":"5 days","description":"Evaluation of white blood cell count"},{"outcome_type":"secondary","measure":"Carbon monoxide","time_frame":"5 days","description":"Evaluation of carbon monoxide in exhaled breath"},{"outcome_type":"secondary","measure":"Spirometry","time_frame":"5 days","description":"Evaluation of spirometry"}]}
{"nct_id":"NCT04683393","start_date":"2016-10-03","enrollment":110,"brief_title":"A Single-centre Prospective Study to Explore the Role of Frailty in Patients With Multiple Myeloma.","official_title":"A Single-centre Prospective Study to Explore the Role of Frailty in Patients With Multiple Myeloma.","primary_completion_date":"2022-02-10","study_type":"Observational","rec_status":"Active, not recruiting","completion_date":"2022-10-01","last_update":"2020-12-24","description":"This study aims to explore the markers of frailty in a \"real world\" population of MM patients, and to monitor changes to those markers throughout treatment and follow-up. Clinical, physical and biological parameters will be collected by interviewing the patients via questionnaires, physical tests and blood analyses. All these will be done during routine visits of the patients' care pathway, minimising the impact on patient lifestyles. The patients will then be stratified according to the geriatric assessment into 3 groups (fit, non-fit, frail) and the changes to these parameters will be compared within these 3 groups throughout the treatment and the follow-up phase for a minimum of 24 months. The markers of frailty will also be measured in a group of healthy subjects and the results will be compared with those of patients with MM. The characterisation of markers of frailty will be a starting point to develop strategies to reduce the causes of frailty, hence it will reduce the treatment-related toxicity, improve quality of life and eventually the outcome for patients with MM.","other_id":"MMM-FRAILTY16","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"All individuals will be considered for inclusion in this study regardless of age,\r\n        disability, gender reassignment, marriage and civil partnership, pregnancy and maternity,\r\n        race, religion and belief, sex, and sexual orientation except where the study inclusion and\r\n        exclusion criteria EXPLICITLY state otherwise. Participants with the above characteristics\r\n        are eligible:","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Aged 18 years or greater\r\n\r\n          -  Newly diagnosed or relapse/refractory patients with multiple myeloma including\r\n             non-secretory multiple myeloma. If patients are at diagnosis, they need to have a\r\n             myeloma defining events (MDE) as reported in Appendix B. If they are at relapse they\r\n             need to meet the criteria for relapse as per Appendix C.\r\n\r\n          -  Patients due to start any anti-myeloma treatment irrespectively from the line of\r\n             treatment\r\n\r\n          -  Able to provide written informed consent\r\n\r\n          -  Patients enrolled in other clinical trials can be enrolled in this study. Patients\r\n             will not attend the hospital more frequently if enrolled in this study. In fact all\r\n             the assessment, tests and questionnaires will be done whilst the patients are\r\n             attending the hospital for routine appointments.\r\n\r\n        Inclusion criteria for healthy subjects:\r\n\r\n          -  Aged 50 years or greater\r\n\r\n          -  Able to provide written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Not able to give informed consent\r\n\r\n          -  MGUS or sMM without MDE\r\n\r\n          -  Patients receiving ongoing treatment for MM with the exclusion of steroids (maximal\r\n             dose of Dexamethasone 160 mg in last 2 weeks or equivalent) and radiotherapy for\r\n             spinal cord compression (SCC). The reason for this exclusion is that the baseline\r\n             measurements need to be done before starting a proper line of chemotherapy and not in\r\n             the middle of a treatment in order to be comparable between patients.\r\n\r\n          -  Patient received allogeneic stem cell transplant at any stage of treatment. The reason\r\n             being that some markers (i.e. telomere length) can consistently change following an\r\n             allogeneic stem cell transplant\r\n\r\n        Exclusion criteria for healthy subjects:\r\n\r\n          -  Not able to give informed consent\r\n\r\n          -  History of past or present cancer requiring treatment (surgery and/or radiotherapy\r\n             and/or chemotherapy)\r\n      ","sponsor":"Manchester University NHS Foundation Trust","sponsor_type":"Other","conditions":"Multiple Myeloma","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Frailty status defined according to Geriatric assessment","time_frame":"18 months from Recruitment End","description":"Lawton Instrumental Activity of Daily Living (IADL) Activities of daily living scale.Patients are scored according to their highest level of functioning in that category. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women, and 0 through 5 for men"},{"outcome_type":"primary","measure":"Frailty status defined according to Geriatric assessment","time_frame":"18 months from Recruitment End","description":"Katz Activity of Daily Living (ADL) Questionnaires with a points scale of 1 or 0, with 0 dependence and 1 independence"},{"outcome_type":"primary","measure":"Frailty status defined according to biomarkers of frailty: Teleomere Length","time_frame":"18 months from Recruitment End","description":"Biomarkers: Telomere length analysis: on leukocytes and bone marrow by QPCR via the method of Cawthon"},{"outcome_type":"primary","measure":"Frailty status defined according to biomarkers of frailty: miRNAs","time_frame":"18 months from Recruitment End","description":"Biomarkers:miRNAs expression leukocytes via relative quantitative real-time PCR (qRT-PCR)"},{"outcome_type":"primary","measure":"Frailty status defined according to biomarkers of frailty: CDKN2A","time_frame":"18 months from Recruitment End","description":"Biomarkers: CDKN2A expression on leukocytes via relative quantitative real-time PCR (qRT-PCR)"},{"outcome_type":"primary","measure":"Frailty status defined according to Geriatric assessment","time_frame":"18 months from Recruitment End","description":"Charlson Comorbidity Index (CCI). Predicts 10 year survival in patients with multiple comorbidities. Scale is No 0, Yes is plus score depending on disease. Lower the overall points the greater survival rate"}]}
{"nct_id":"NCT03459599","start_date":"2016-10-01","phase":"N/A","enrollment":716,"brief_title":"Antibiotic Prophylaxis in Ragged Placental Membranes","official_title":"Antibiotic Prophylaxis in Ragged Placental Membranes: A Prospective, Multicenter, Randomized Trial","primary_completion_date":"2017-03-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-08-01","last_update":"2018-03-12","description":"In some centres, women are routinely given a course of antibiotics postnatally if ragged placental membranes were present at delivery. The investigators examined the necessity such an intervention.","other_id":"16-1016-31034","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        All women who delivered vaginally beyond 24+0 weeks of gestation and were found to have\r\n        ragged or retained placental membranes immediately after the third stage of labour were\r\n        invited to participate in the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Fever, within 5 days preceding delivery (Axillary temperature > 37.5oC on 2 or more\r\n             occasions at least 1 hour apart or temperature > 38oC on one occasion). This also\r\n             includes intrapartum fever.\r\n\r\n          2. Required oral or intravenous antibiotics for any other obstetric-related (ex. third or\r\n             fourth degree tears, preterm prelabour rupture of membranes) or non- obstetric related\r\n             (ex. pneumonia, acute pyelonephritis) reasons\r\n\r\n          3. Prolonged rupture of membrane (>18 hours)\r\n\r\n          4. Retroviral disease, on long term oral or parenteral steroid or receiving other forms\r\n             of immunosuppressants, including chemotherapy within the last one year.\r\n\r\n          5. Vaginal delivery for an intrauterine death\r\n\r\n          6. Penicillin allergy\r\n      ","sponsor":"Sarawak General Hospital","sponsor_type":"Other","conditions":"Endometritis Postpartum|Endometritis|Membranes; Retained","interventions":[{"intervention_type":"Drug","name":"Drug: Prophylactic antibiotics","description":"Amox-clav given to eligible women as per existing protocol, which is 625mg three times a day, for a week"},{"intervention_type":"Other","name":"Other: No prophylaxis (Amox-clav withheld)","description":"Withholding Amox-clav, which is the current local practice for women with ragged placental membranes. This was replaced with appropriate counselling on signs and symptoms of endometritis, when and where women should present if the symptoms above occur. A follow up phone call was performed at 2 weeks and 6 weeks postpartum to ascertain well-being of patients"}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of postpartum endometritis","time_frame":"6 weeks postpartum","description":"Postpartum endometritis is defined as follows, when presenting anytime within 6 weeks postpartum\r\nFever (Axillary temperature > 37.5 degrees Celcius on 2 or more occasions at least 1 hour apart or temperature > 38 degrees Celcius on one occasion), occurring in the absence of apparent source of infection or alternative foci of infection.\r\nIncreasing lochia loss or offensive lochia.\r\nLower abdominal pain or suprapubic tenderness on palpation.\r\nThe diagnosis is further supported by the following:\r\nElevated total white cell count > 11.0 x 109 cells/L\r\nPositive genital swab culture.\r\nIncidence is calculated as follows:\r\nNumber of patients diagnosed with endometritis in each arm/total number of patients allocated to each arm"},{"outcome_type":"secondary","measure":"ICU admission rate","time_frame":"6 weeks postpartum","description":"ICU admission as a result of endometritis. It is measured as follows:\r\na. ICU admission rate in prophylactic antibiotic group= (Number of patients requiring ICU admissions and given antibiotic prophylaxis, regardless of duration/total number of patients given antibiotics prophylaxis )\r\na. ICU admission rate in \"no prophylaxis\" group\r\n= (Number of patients requiring ICU admissions and NOT given antibiotic prophylaxis, regardless of duration/total number of patients NOT given antibiotics prophylaxis)"},{"outcome_type":"secondary","measure":"Rate of surgical evacuation of retained products of conception","time_frame":"6 weeks postpartum","description":"Surgical procedure required as a result of ragged placental membrane or its complications. It is calculated as follows\r\nSurgical evacuation of retained products of conception in prophylaxis group= (Number of patients requiring surgical procedure and given antibiotic prophylaxis, regardless of duration/total number of patients given antibiotics prophylaxis )\r\nSurgical evacuation of retained products of conception in \"no prophylaxis\" group= (Number of patients requiring surgical procedure and NOT given antibiotic prophylaxis, regardless of duration/total number of patients NOT given antibiotics prophylaxis )"},{"outcome_type":"secondary","measure":"Rate of Blood transfusion","time_frame":"6 weeks postpartum","description":"Pack cell transfusion required as secondary to a complication from ragged placental membranes. This can be due to postpartum endometritis or surgical evacuation. It is calculated based on the number of patients requiring transfusion. The number of pack cells required per patient would be also be described.\r\nBlood transfusion in prophylaxis group= (Number of patients requiring pack cell transfusion and given antibiotic prophylaxis, regardless of duration/total number of patients given antibiotics prophylaxis )\r\nBlood transfusion in \"no prophylaxis group\"= (Number of patients requiring pack cell transfusion and were NOT given antibiotic prophylaxis, regardless of duration/total number of patients NOT given antibiotics prophylaxis )"}]}
{"nct_id":"NCT02905227","start_date":"2016-09-30","phase":"Phase 1","enrollment":60,"brief_title":"A Study of the Pulmonary Safety and Pharmacokinetics of Zolmitriptan Inhalation Powder","official_title":"A Phase 1 Study of the Pulmonary Safety and Pharmacokinetics of Zolmitriptan Inhalation Powder in Chronic Smokers and People With Mild or Moderate Asthma Compared to Healthy Volunteers","primary_completion_date":"2016-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-12-31","last_update":"2018-02-14","description":"This study is an open-label, parallel group study to evaluate acute pulmonary safety and Pharmacokinetics (PK) of two doses, separated by 2 hours, of CVT-427 zolmitriptan inhalation powder in three groups of adults: those with asthma, those who smoke and healthy volunteers.","other_id":"TRIP-PK-1041","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  eligible subjects will be men or women aged 18 to 65 years inclusive;\r\n\r\n          -  body mass index (BMI) 18 to 30 kg/m2;\r\n\r\n          -  healthy adults must be in general good health with no clinically significant\r\n             abnormalities that would affect ability to complete study.\r\n\r\n          -  subjects with asthma must be non-smokers who have a forced expiratory volume in one\r\n             second (FEV1)  60% of predicted for race, age, sex, and height;\r\n\r\n          -  subjects who smoke must have at least a 12-month, 0.5 pack of cigarettes per day\r\n             history or the equivalent consumption of cigars and a positive result for plasma\r\n             cotinine.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  subjects with asthma will be excluded for more than 2 hospitalizations or emergency\r\n             room visits, or more than 3 courses of systemic steroids in the past 12 months or 1\r\n             course within the past 8 weeks for respiratory illness;\r\n\r\n          -  asthma exacerbation within 8 weeks of before screening;\r\n\r\n          -  unscheduled or urgent visit to any medical facility for asthma-related problems within\r\n             8 weeks before screening;\r\n\r\n          -  history of intubation or intensive care unit admission for asthma in the past 5 years.\r\n\r\n          -  Subjects who smoke will be excluded if they have intrinsic lung disease including\r\n             asthma or chronic obstructive pulmonary disease (COPD) with an FEV1 of <60% of\r\n             predicted and a score of 2 on the Medical Research Council Dsypnea Scale (MRC);\r\n\r\n          -  any cardiovascular risk factor or contraindication for the use of triptans\r\n\r\n          -  use of nonselective monamine oxidase inhibitors (MAOI), serotonin reuptake inhibitors\r\n             (SSRIs), propranolol, or cimetidine within 4 weeks prior to the Screening Visit, or\r\n             planned use during the study;\r\n\r\n          -  positive serology test (hepatitis B virus surface antigen [HBsAg], hepatitis C virus\r\n             [HCV] antibody, human immunodeficiency virus [HIV] 1 & 2 antibodies).\r\n      ","sponsor":"Acorda Therapeutics","sponsor_type":"Industry","conditions":"Migraine","interventions":[{"intervention_type":"Drug","name":"Drug: CVT-427 (zolmitriptan inhalation powder)","description":"Each subject received 2 self-administered doses of 3.0 mg CVT-427 (zolmitriptan inhalation powder), 2 hours apart."}],"outcomes":[{"outcome_type":"primary","measure":"Change in measure of pulmonary function via Spirometry","time_frame":"within 1 hour prior to dose and up to 24 hours post-dose."},{"outcome_type":"primary","measure":"Maximum observed plasma drug concentration (Cmax)","time_frame":"up to 24 hours post-dose."},{"outcome_type":"primary","measure":"Maximum observed plasma drug concentration (tmax)","time_frame":"up to 24 hours post-dose."},{"outcome_type":"primary","measure":"Area under the concentration time curve over the dosing interval (AUC0-last)","time_frame":"up to 24 hours post-dose."},{"outcome_type":"secondary","measure":"Number of subjects with Adverse Events (AEs) including Serious AEs","time_frame":"up to 5 days"}]}
{"nct_id":"NCT03839069","start_date":"2016-09-30","phase":"N/A","enrollment":30,"brief_title":"Minor Salivary Gland Transplantation for Cicatrizing Conjunctivitis","official_title":"The Effects of Minor Salivary Gland Transplantation for Cicatrizing Conjunctivitis","primary_completion_date":"2020-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2021-06-30","last_update":"2019-02-15","description":"This is a prospective study that aimed to observe the therapeutic effects of minor salivary gland transplantation for cicatrizing conjunctivitis patients.","other_id":"201503027DINB","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  age 20-85 years old\r\n\r\n          -  unilateral or bilateral cicatrizing conjunctivitis\r\n\r\n          -  severe aqueous deficiency dry eye ( Schirmer I test result of less than 2mm)\r\n\r\n          -  chronic ocular surface disease score (COCS) over 3 points\r\n\r\n          -  Oxford scheme over grade III\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  active ocular infection\r\n\r\n          -  active corneal melting\r\n\r\n          -  severe xerostomia (modified Schirmer I test result of less than 25mm)\r\n      ","sponsor":"National Taiwan University Hospital","sponsor_type":"Other","conditions":"Cicatrizing Conjunctivitis|Stevens-Johnson Syndrome Toxic Epidermal Necrolysis Spectrum|Sjogren Syndrome|Mucous Membrane Pemphigoid|Chronic Graft Versus Host Disease|Chemical Burn to Eye","interventions":[{"intervention_type":"Procedure","name":"Procedure: minor salivary gland transplantation","description":"The investigators will harvest the autologous labial salivary gland tissue and transplant to the upper and lower conjunctival fornix of the lesion eye."}],"outcomes":[{"outcome_type":"primary","measure":"the change of Schirmer's test result (basic tear secretion in mm) from baseline to 12 months after operation","time_frame":"the Schirmer's test will be performed every three months until 12 months after operation","description":"to compare the Schirmer's test between baseline and 12 months after operation. The higher Schirmer's test results, the better tear secretion function."},{"outcome_type":"primary","measure":"the change of ocular surface disease index (OSDI) ( ranged from 0-100) from baseline to 12 months after operation","time_frame":"the OSDI will be monitored every three months until 12 months","description":"to compare the OSDI between baseline and 12 months after operation. The higher the OSDI value, the worse of subjective ocular surface disease related symptoms."},{"outcome_type":"primary","measure":"the change of chronic ocular complication score (COCS) ( ranged from 0-12) from baseline to 12 months after operation","time_frame":"the COCS will be monitored every three months until 12 months after operation","description":"to compare the COCS between baseline and 12 months after operation. The higher the COCS scores, the more ocular surface complications."},{"outcome_type":"secondary","measure":"the change of conjunctival impression cytology scores (ranged from 0-5) from baseline to 12 months after operation","time_frame":"the impression cytology will be performed every three months until 12 months after operation","description":"to compare the scores of conjunctival impression cytology between baseline and 12 months after operation. The higher the conjunctival impression cytology scores, the worse squamous metaplasia of the ocular surface."}]}
{"nct_id":"NCT02963623","start_date":"2016-09-30","enrollment":54,"brief_title":"Fibtem Predicts Postoperative Bleeding","official_title":"The Prediction of Postoperative Hemorrahge Amount in Total Knee Replacement Using Fibtem","primary_completion_date":"2017-09-30","study_type":"Observational","rec_status":"Completed","completion_date":"2017-09-30","last_update":"2018-03-09","description":"Retrospective study to evaluate if FIBTEM predicts the amount of postoperative bleeding in total knee replacement patients.","other_id":"KUH1160104","observational_model":"Other","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":19,"maximum_age":99,"population":"total knee replacement patients","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  patients who underwent primany unilateral total knee replacement arthroplasty under\r\n             general anesthesia\r\n\r\n          -  patients who had FIBTEM performed\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  surgery under regional anaesthesia\r\n\r\n          -  a simultaneous bilateral total knee replacement arthroplasty\r\n\r\n          -  the second surgery of staged total knee replacement arthroplasty\r\n\r\n          -  revision of total knee replacement arthroplasty\r\n\r\n          -  patients who received intraoperative transfusion\r\n\r\n          -  patients who use tranexamic acid\r\n\r\n          -  patients who received fibrinolytic agents because of perioperative thromboembolic\r\n             event\r\n\r\n          -  patients who refused transfusion because of religious belief of personal causes\r\n      ","sponsor":"Konkuk University Medical Center","sponsor_type":"Other","conditions":"Postoperative Hemorrhage","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"haemoglobin","time_frame":"postoperative periods","description":"the decrement of haemoglobin"}]}
{"nct_id":"NCT02821715","start_date":"2016-09-30","phase":"Phase 2","enrollment":51,"brief_title":"Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients","official_title":"Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients","primary_completion_date":"2018-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-02-28","last_update":"2020-09-04","description":"This Phase 2 study is a 8-site, double-blind, randomised, placebo-controlled, 3-way cross-over trial, involving 3 treatments with Modafinil 300 mg or the combination drug THN102 (Modafinil/Flecainide 300 /3 mg, Modafinil/Flecainide 300 /27 mg).","other_id":"THN102-201","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Main inclusion Criteria:\r\n\r\n          -  Patients with a diagnosis of narcolepsy type 1 (i.e. with cataplexy) or type 2\r\n             (without cataplexy) according to the International Classification of Sleep Disorders\r\n             (ICSD-3) criteria.\r\n\r\n          -  Body mass index >18 kg/m2 and <35 kg/m2.\r\n\r\n          -  Patients treated with modafinil at stable dosage for at least 2 months and still\r\n             complaining of excessive daily somnolence (EDS) despite the treatment\r\n\r\n          -  Epworth Sleepiness Scale (ESS) score should be  14/24 during the baseline period.\r\n\r\n        Main exclusion Criteria:\r\n\r\n          -  Patients with an untreated sleep apnea syndrome (respiratory disorder index > 30/h) or\r\n             who have any other cause of daytime sleepiness as assessed on patient history.\r\n\r\n          -  Psychiatric and neurological disorders, other than narcolepsy/cataplexy, such as\r\n             Parkinson's disease, Alzheimer's disease, Huntington's Chorea, multiple sclerosis,\r\n             moderate or severe psychosis or dementia, bipolar illness, epilepsy, severe clinical\r\n             anxiety or depression, Beck Depression Inventory  21 or with suicidal risk (if item >\r\n             0), or other problem that in the investigator's opinion would preclude the patient's\r\n             participation and completion of this trial or comprise reliable representation of\r\n             subjective symptoms.\r\n\r\n          -  Contraindication to flecainide\r\n      ","sponsor":"Theranexus","sponsor_type":"Industry","conditions":"Narcolepsy","interventions":[{"intervention_type":"Drug","name":"Drug: Active comparator: Modafinil + placebo"},{"intervention_type":"Drug","name":"Drug: THN102 300/3"},{"intervention_type":"Drug","name":"Drug: THN102 300/27"}],"outcomes":[{"outcome_type":"primary","measure":"Epworth Sleepiness Scale (ESS)","time_frame":"14 days after the beginning of treatment period","description":"Range 0 to 24, low score indicates good outcome"},{"outcome_type":"secondary","measure":"14-item Fatigue Scale","time_frame":"14 days after the beginning of treatment period","description":"Fatigue scale is a rating scale completed by the participants at each visit starting from baseline to last visit; 14 questions to be ticked off by \"yes\" or \"No\" by the patient. 0 : No fatigue 14 : worst fatigue condition"},{"outcome_type":"secondary","measure":"Questionnaire EQ-5D (European Quality of Life EQ-5D) (Questionnaire Part)","time_frame":"14 days after the beginning of the screening","description":"EQ-5D is a quality of life questionnaire filled in by the participants from screening to the last visit (all visits).\r\nThe EQ-5D assesses the status on the day of visit and not over the past week. It has two parts:\r\nThe first part is a descriptive system that assesses five distinct health states/dimensions: Mobility (MO), Self-care (SC), Usual activities (UA), Pain/discomfort, Anxiety/depression (AD). A higher score signifies a higher number of symptoms present.\r\nThe second part is a 100 mm VAS (EQ-VAS). An increase in VAS indicates an improvement in health state."},{"outcome_type":"secondary","measure":"Patient Global Impression of Change (PGI-C)","time_frame":"14 days after the beginning of treatment period","description":"PGI-C is a scale completed by the participants starting from screening to last Last visit (all the visits).\r\nParticipants have to chose 1 condition among 7 : Very much improved/ Much improved/ Minimally improved/ No change/ Minimally worse/ Much worse/ Very much worse.\r\n1 is the best score (very much improved) 7 is the worse score (very much worse)"},{"outcome_type":"secondary","measure":"Clinical Global Impression of Change (CGI-C) Global Impression","time_frame":"14 days after the end of treatment period I","description":"CGI-C (change from baseline) is a scale completed by the investigator at V3, V4 , V5 and V6 for global impression the investigator or his/her designee has to score 3 items : global impression/ sleepiness and Cataplexy.\r\nFor each item the investigator or his/her designee has to chose 1 condition among 7 : Very much improved/ Much improved/ Minimally improved/ No change/ Minimally worse/ Much worse/ Very much worse.\r\n1 is the best score (very much improved) 7 is the worse score (very much worse)"},{"outcome_type":"secondary","measure":"Beck Depression Inventory (BDI)","time_frame":"14 days","description":"Beck Depression Inventory (BDI) evaluation for depressive symptoms (including suicidal thoughts). The scale is completed by the participants from baseline, to last visit (all except screening visit). The questionnaire contains 21 items. Each must be scored from 0 to 3, minimum score = 0, maximum score = 63. A high score indicates increased severity of depression."},{"outcome_type":"secondary","measure":"Patient Global Impression for Severity (PGI-S) Global Score","time_frame":"14 days","description":"PGI-S us a scale filled by the participant from screening to last visit (all the visits) Participants have to chose 1 condition among 7 : 1 Normal-Not ill at all/ 2 borderline ill/ 3 mildly ill/ 4 moderately ill/ 5 markedly ill/ 6 severely ill/ 7 among the most extremely ill patient\r\n1 is the best score (very much improved) 7 is the worse score (very much worse)"},{"outcome_type":"secondary","measure":"Clinical Global Impression of Change (CGI-C) Sleepiness","time_frame":"14 days after the end of treatment period I","description":"CGI-C (change from baseline) is a scale completed by the investigator at V3, V4 , V5 and V6 for sleepiness\r\nthe investigator or his/her designee has to score 3 items : global impression/ sleepiness and Cataplexy.\r\nFor each item the investigator or his/her designee has to chose 1 condition among 7 : Very much improved/ Much improved/ Minimally improved/ No change/ Minimally worse/ Much worse/ Very much worse.\r\n1 is the best score (very much improved) 7 is the worse score (very much worse)"},{"outcome_type":"secondary","measure":"Clinical Global Impression of Change (CGI-C) Cataplexy","time_frame":"14 days after the end of treatment period I","description":"CGI-C (change from baseline) is a scale completed by the investigator at V3, V4 , V5 and V6 for Cataplexy\r\nthe investigator or his/her designee has to score 3 items : global impression/ sleepiness and Cataplexy.\r\nFor each item the investigator or his/her designee has to chose 1 condition among 7 : Very much improved/ Much improved/ Minimally improved/ No change/ Minimally worse/ Much worse/ Very much worse.\r\n1 is the best score (very much improved) 7 is the worse score (very much worse)"},{"outcome_type":"secondary","measure":"Clinical Global Impression for Severity (CGI-S) Global Score","time_frame":"14 days after the end of treatment period I","description":"CGI-S is a scale completed by the investigator at each visit : Item global impression\r\nCGI-S us a scale filled by the Investigator or his/her designee from screening to last visit (all the visits) Investigators have to chose 1 condition among 7 : 1 normal-not ill at all/ 2 borderline ill/ 3 mildly ill/ 4 moderately ill/ 5 markedly ill/ 6 severely ill/ 7 among hte most extremely ill patient\r\n1 is the best score (very much improved) 7 is the worse score (very much worse)\r\nCGI-S scale explores 3 items : Global impression/ Sleepiness/ Cataplexy"},{"outcome_type":"secondary","measure":"Clinical Global Impression for Severity (CGI-S) Sleepiness","time_frame":"14 days after the end of treatment period I","description":"CGI-S is a scale completed by the investigator at each visit for Sleepiness\r\nCGI-S us a scale filled by the Investigator or his/her designee from screening to last visit (all the visits) Investigators have to chose 1 condition among 7 : 1 Normal-Not ill at all/ 2 Borderline ill/ 3 Mildly ill/ 4 Moderately ill/ 5 Markedly ill/ 6 severely ill/ 7 Among the most extremely ill patient\r\n1 is the best score (very much improved) 7 is the worse score (very much worse)\r\nCGI-S scale explores 3 items : Global impression/ Sleepiness/ Cataplexy"},{"outcome_type":"secondary","measure":"Clinical Global Impression for Severity (CGI-S) Cataplexy","time_frame":"14 days after the end of treatment period I","description":"CGI-S is a scale completed by the investigator at each visit for Cataplexy\r\nCGI-S us a scale filled by the Investigator or his/her designee from screening to last visit (all the visits) Investigators have to chose 1 condition among 7 : 1 Normal-Not ill at all/ 2 Borderline ill/ 3 Mildly ill/ 4 Moderately ill/ 5 Markedly ill/ 6 severely ill/ 7 Among the most extremely ill patient\r\n1 is the best score (very much improved) 7 is the worse score (very much worse)\r\nCGI-S scale explores 3 items : Global impression/ Sleepiness/ Cataplexy"},{"outcome_type":"secondary","measure":"EQ-5D European Quality of Life EQ-5D (Visual Analogic Scale Part)","time_frame":"14 days","description":"EQ-5D is a quality of life questionnaire filled in by the participants from screening to the last visit (all visits).\r\nThe EQ-5D is a questionnaire assessing the quality of life of the patient. It has two parts:\r\nThe first part is a descriptive system that assesses five distinct health states/dimensions: Mobility (MO), Self-care (SC), Usual activities (UA), Pain/discomfort, Anxiety/depression (AD). A higher score signifies a higher number of symptoms present.\r\nThe second part is a 100 mm Visual analogic scale (EQ-VAS). An higher score in VAS indicates a better health state.\r\nThe questionnaire is assessed at baseline and all subsequent visits"}]}
{"nct_id":"NCT02909348","start_date":"2016-09-30","enrollment":25,"brief_title":"Immunophenotyping of Melanoma Patients on Treatment With Pembrolizumab","official_title":"Phenotyping of Blood Samples to Detect Autoimmune Signature Following Immunotherapy With Pembrolizumab","primary_completion_date":"2019-10-31","study_type":"Observational","rec_status":"Completed","completion_date":"2019-10-31","last_update":"2019-12-02","description":"There is a new form of cancer treatment called immunotherapy which does not attack cancer directly but works on the immune system to make it more effective. This type of treatment may have side effects which are called autoimmune side effects and are caused by the immune system attacking the normal parts of the body. At the moment doctors cannot predict which patients may be at more risk of developing such autoimmune side effects and doctors also cannot predict which patients are more likely to benefit. This study will analyse blood samples from patients receiving immunotherapy to see if markers can be identified to help make such predictions.","other_id":"9797","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients with advanced malignant melanoma of cutaneous or mucosal origin who are BRaf wild\r\n        type and eligible for first line immunotherapy with pembrolizumab","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Be willing and able to provide written informed consent for the trial.\r\n\r\n          2. Be 18 years of age on day of signing informed consent.\r\n\r\n          3. Have a confirmed metastatic melanoma of cutaneous or mucosal origin, and if cutaneous\r\n             to be confirmed BRaf wild-type.\r\n\r\n          4. Be willing to provide blood samples in line with the study protocol.\r\n\r\n          5. Have a performance status of 0 to 2 on the ECOG Performance Scale.\r\n\r\n          6. Demonstrate adequate organ function.\r\n\r\n          7. Female subject of childbearing potential should have a negative urine or serum\r\n             pregnancy within 72 hours prior to receiving the first dose of study medication.\r\n\r\n          8. Female subjects of childbearing potential must be willing to use an adequate method of\r\n             contraception.\r\n\r\n          9. Male subjects of childbearing potential must agree to use an adequate method of\r\n             contraception.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Is currently participating and receiving study therapy or has participated in a study\r\n             of an investigational agent and received study therapy within 4 weeks of the first\r\n             dose of treatment.\r\n\r\n          2. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any\r\n             other form of immunosuppressive therapy within 7 days prior to the first dose of trial\r\n             treatment.\r\n\r\n          3. Has a known history of active TB (Bacillus Tuberculosis)\r\n\r\n          4. Hypersensitivity to pembrolizumab or any of its excipients.\r\n\r\n          5. Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study\r\n             Day 1 or who has not recovered (i.e.,  Grade 1 or at baseline) from adverse events\r\n             due to agents administered more than 4 weeks earlier. 6. Has had prior chemotherapy,\r\n             targeted small molecule therapy, or radiation therapy within 2 weeks prior to study\r\n             Day 1 or who has not recovered (i.e.,  Grade 1 or at baseline) from adverse events\r\n             due to a previously administered agent.\r\n\r\n        7. Has a known additional malignancy that is progressing or requires active treatment.\r\n        Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin\r\n        that has undergone potentially curative therapy or in situ cervical cancer.\r\n\r\n        8. Has known active central nervous system (CNS) metastases and/or carcinomatous\r\n        meningitis. Subjects with previously treated brain metastases may participate provided they\r\n        are stable (without evidence of progression by imaging for at least four weeks prior to the\r\n        first dose of trial treatment and any neurologic symptoms have returned to baseline), have\r\n        no evidence of new or enlarging brain metastases, and are not using steroids for at least 7\r\n        days prior to trial treatment. This exception does not include carcinomatous meningitis\r\n        which is excluded regardless of clinical stability.\r\n\r\n        9. Has active autoimmune disease that has required systemic treatment in the past 2 years\r\n        (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).\r\n        Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement\r\n        therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic\r\n        treatment.\r\n\r\n        10. Has known history of, or any evidence of active, non-infectious pneumonitis.\r\n\r\n        11. Has an active infection requiring systemic therapy. 12. Has a history or current\r\n        evidence of any condition, therapy, or laboratory abnormality that might confound the\r\n        results of the trial, interfere with the subject's participation for the full duration of\r\n        the trial, or is not in the best interest of the subject to participate, in the opinion of\r\n        the treating investigator.\r\n\r\n        13. Has known psychiatric or substance abuse disorders that would interfere with\r\n        cooperation with the requirements of the trial.\r\n\r\n        14. Is pregnant or breastfeeding, or expecting to conceive or father children within the\r\n        projected duration of the trial, starting with the pre-screening or screening visit through\r\n        120 days after the last dose of trial treatment.\r\n\r\n        15. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.\r\n\r\n        16. Has a known history of Human Immunodeficiency Virus (HIV). 17. Has known active\r\n        Hepatitis B or Hepatitis C. 18. Has received a live vaccine within 30 days of planned start\r\n        of study therapy.\r\n      ","sponsor":"Royal Free Hospital NHS Foundation Trust","sponsor_type":"Other","conditions":"Neoplasms|Melanoma","interventions":[{"intervention_type":"Drug","name":"Drug: Pembrolizumab","description":"3mg/kg, intravenous and on day1 of each 21 day cycle until progression or unacceptable toxicity develops."}],"outcomes":[{"outcome_type":"primary","measure":"Change in immune markers in blood following immunotherapy with pembrolizumab","time_frame":"5 fixed time points (baseline, pre-cycle 1, 3 & 5 and 6 months) and 2 optional (after adverse event or response/progression)"}]}
{"nct_id":"NCT03399383","start_date":"2016-09-30","phase":"N/A","enrollment":150,"brief_title":"Adherence in Chronic Adrenal Insufficiency","official_title":"Adherence and Perception With Hormone Replacement Therapy in Chronic Adrenal Insufficiency - Influence of a Standardized Patient Education","primary_completion_date":"2018-09-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2018-12-31","last_update":"2018-01-23","description":"Adherence, concerns and satisfaction with information in German patients with adrenal insufficiency as well as the influence of a standardized education program will be assessed by a compared cross-sectional and longitudinal study.","other_id":"Compliance-TRIAL","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","intervention_model_description":"Within the longitudinal part of the trial, patients with chronic adrenal insufficiency will be assessed by questionnaire before and after participation in the standardized education program (=intervention).","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age > 18 years\r\n\r\n          -  Patient's written informed consent\r\n\r\n          -  Ability to comply with the protocol procedures\r\n\r\n          -  Patients with chronic adrenal insufficiency under established stable replacement\r\n             therapy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Age < 18 years\r\n      ","sponsor":"Wuerzburg University Hospital","sponsor_type":"Other","conditions":"Adrenal Insufficiency","interventions":[{"intervention_type":"Other","name":"Other: Patient education","description":"Participation in the standardized education program (90min patient education). During sessions of 90-120 minutes duration, patients are educated in basic knowledge on adrenal insufficiency including the correct behaviour in emergency settings. Participants are provided with emergency cards and sets and are trained in self-injection of glucocorticoids."}],"outcomes":[{"outcome_type":"primary","measure":"Beliefs about Medicines Questionnaire (BMQ)","time_frame":"6 months","description":"Evaluation of \"Beliefs about Medicines\" by BMQ-questionnaire (modified BMQ AI Specific© by Prof Rob Horne). The modified BMQ AI Specific© comprises: a 5-item Glucocorticoid-Necessity subscale assessing the participant's views about their personal need for the glucocorticoid medication and an 11-item Glucocorticoid-Concerns subscale assessing participants' concerns about the potential adverse consequences of taking glucocorticoids. For each BMQ statement, participants indicated their agreement on a 5-point Likert scale (range 1 = strongly disagree to 5 = strongly agree). GC-Necessity and GC-Concerns scores are computed by summing all subscale responses, then dividing by the number of items (range 1-5). Scores near five indicate high Necessity. Scores near one indicate high Concern."},{"outcome_type":"primary","measure":"Satisfaction with Information about Medicines Scale (SIMS)","time_frame":"6 months","description":"Evaluation of \"Satisfaction with Information about Medicines\" by SIMS-questionnaire (Prof Rob Horne). Participants complete the SIMS© to indicate their satisfaction with the information they had received about their glucocorticoids. The SIMS has two subscales. The first assesses satisfaction with the information received about the Action and Usage of glucocorticoids (SIMS AU 9-items). The second assesses satisfaction with information about dealing with Potential Problems associated with glucocorticoids (SIMS PP 8-items). For each subscale item, participants state whether they were satisfied with the amount of information they had received (about right, none needed) or dissatisfied (too much, too little, none received). Subscale scores are calculated by counting the total number of 'satisfied' responses."},{"outcome_type":"primary","measure":"Medication Adherence Report Scale (MARS)","time_frame":"6 months","description":"Evaluation of \"Adherence\" by MARS-questionnaire. Participants rate their adherence to glucocorticoids on an 8-item Medication Adherence Report Scale (MARS)© (Prof Rob Horne), modified for AI. Participants rate the frequency with which they perform each type of nonadherent behaviour on a 5-point scale (1=very to 5=never). Scores are summed to give a total score (range 8-40); higher scores indicate higher reported adherence."}]}
{"nct_id":"NCT02838784","start_date":"2016-09-30","phase":"N/A","enrollment":134,"brief_title":"Efficacy and Safety of Artacent for Treatment Resistant Lower Extremity Venous and Diabetic Ulcers","official_title":"The Efficacy and Safety of Artacent for Treatment Resistant Lower Extremity Venous and Diabetic Ulcers: A Prospective Randomized Study","primary_completion_date":"2018-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2018-12-31","last_update":"2017-10-13","description":"This study will compare the proportion of patients who have wound closure within 12 weeks as well as the time to wound closure in patients receiving Artacent versus standard of care for treatment of non-healing lower extremity wounds. The recurrence of healed wounds will be assessed at 6 months via a telephone survey","other_id":"16-001","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age 18 years or older\r\n\r\n          -  Able and willing to give consent and to comply with study\r\n\r\n          -  Lower extremity ulcer between 1 and 25 cm2 point after the 4 week run-in period\r\n\r\n          -  Has received documented SOC treatment for 4 weeks or greater duration resulting in\r\n             <50% reduction in the ulcer size\r\n\r\n          -  No clinical signs of infection at the ulcer site\r\n\r\n          -  Serum Creatinine below 3.0 mg/dl\r\n\r\n          -  Serum HgA1c below 12%\r\n\r\n          -  Adequate circulation to the affected limb with ABI between 0.7 and 1.2 or\r\n             tri-/bi-phasic arterial waveforms at the ankle of the affected leg.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Is participating in another wound study\r\n\r\n          -  Has a Charcot foot\r\n\r\n          -  Has previously received a different biological graft on the target foot\r\n\r\n          -  Has more than one lower extremity ulcer\r\n\r\n          -  Has an ulcer that probes to bone or involves tendon, muscle, joint capsule or has\r\n             sinus tracts\r\n\r\n          -  Is currently receiving radiation or chemotherapy\r\n\r\n          -  Has an autoimmune connective tissue disorder\r\n\r\n          -  Is taking any medication known to be an immune system modulator\r\n\r\n          -  Is pregnant or is considering becoming pregnant within the next 6 months\r\n      ","sponsor":"Tides Medical","sponsor_type":"Industry","conditions":"Venous Ulcer|Foot Ulcer, Diabetic","interventions":[{"intervention_type":"Other","name":"Other: Artacent Human Amniotic Membrane","description":"Double layer dehydrated amnion product"},{"intervention_type":"Procedure","name":"Procedure: Standard of Care","description":"Off loading with a cast walker, non-adherent dressings, debridement and moisture retentive dressings"}],"outcomes":[{"outcome_type":"primary","measure":"Wound closure","time_frame":"12 weeks","description":"100% re-epithelialization of the wound without drainage or need for use of a dressing"},{"outcome_type":"primary","measure":"Time to wound closure","time_frame":"12 weeks","description":"# of days to 50% or greater closure"},{"outcome_type":"primary","measure":"Ulcer recurrence","time_frame":"6 months","description":"Telephone survey to capture number of ulcer recurrences and treatment"},{"outcome_type":"secondary","measure":"Quality of Life","time_frame":"12 weeks","description":"EQ-5D survey"},{"outcome_type":"secondary","measure":"Impact of Treatment on Return to Work","time_frame":"12 weeks","description":"Employment status e.g. full-time, part-time, retired, unemployed, etc."},{"outcome_type":"secondary","measure":"Time to full weight bearing status","time_frame":"12 weeks","description":"Ability of the subject to bear full weight and the time to full weight bearing"},{"outcome_type":"secondary","measure":"Adverse Events and Secondary Treatments","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"Number of grafts and graft size(s)","time_frame":"12 weeks","description":"Number and size of grafts used at each application will be collected."},{"outcome_type":"other","measure":"Health economic outcomes","time_frame":"12 weeks","description":"Collection of de-identified Explanation of Benefits (EOB) and/or submitted claims and/or documentation of procedures via CPT coding."}]}
{"nct_id":"NCT03166475","start_date":"2016-09-30","phase":"N/A","enrollment":30,"brief_title":"Ridge Preservation With Provisional Ovoid Pontic","official_title":"Ridge Preservation With Provisional Ovoid Pontic: a Randomized and Controlled Clinical-tomographic Trial","primary_completion_date":"2017-01-10","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-03-30","last_update":"2017-05-25","description":"A prospective randomized controlled trial of 30 patients from the Faculty of Dentistry of the UFJF was conducted. It was included patients who presented indication of extraction of premolars, canines or incisors. All the thirty patients underwent dental extraction and were randomly divided into three groups according to the study methodology. Plaster casts and Cone-Beam Computed Tomography (CBCT) exams were performed for comparative analysis between sample groups and between study times ( imediate postoperative and four months later).","other_id":"Reabilitao Oral","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with indication of extraction of premolars, canines or incisors, which has\r\n             two adjacent teeth, due to root fracture, extensive caries that did not allow\r\n             unfavorable restorative and / or endodontic prognosis, systemically healthy.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who use any drug that influences bone metabolism, patients with a history of\r\n             head radiotherapy and neck, patients undergoing chemotherapy for the treatment of\r\n             malignant tumors at the time of the study, patients with socket severely reabsorbed,\r\n             smokers and pregnant women.\r\n      ","sponsor":"Federal University of Juiz de Fora","sponsor_type":"Other","conditions":"Alveolar Process Atrophy","interventions":[{"intervention_type":"Procedure","name":"Procedure: Surgical procedures","description":"All the extractions were performed under local anaesthesia, minimally traumatic as possible. After the extraction, each patient was treated according to the group of their allocations."}],"outcomes":[{"outcome_type":"primary","measure":"Changes of bone remodelation measured by Cone-Beam Computed Tomography exams and by plaster casts analysis, from baseline to 4 months","time_frame":"Baseline (immediate postoperative) and 4 months after it.","description":"Will be measured width and height buccal-lingual of the ridge for each tooth extracted by the researcher."}]}
{"nct_id":"NCT02870764","start_date":"2016-09-30","phase":"Phase 4","enrollment":156,"brief_title":"The Effect of Dan-shen Extract On Lipoprotein Associated PHospholipase A2 Levels IN Patients With Stable Angina Pectoris","official_title":"A Randomized, Double-blind, Placebo-controlled Trial of Dan-shen Extract in Patients With Stable Angina Pectoris","primary_completion_date":"2017-05-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2017-08-31","last_update":"2016-09-13","description":"This is a randomized, double-blind, placebo-controlled, adaptive clinical trial, which will assess the effect of DanshenDuofensuanyan[Danshen (a kind of Chinese herbal drug) extract] treatment on Lipoprotein associated phospholipase A2 level in patients with stable angina pectoris.","other_id":"TaizhouFPH-001","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age:18 years-75 years;\r\n\r\n          2. Written informed consent;\r\n\r\n          3. Patients with a clinical diagnosis of chronic stable angina, which fulfil one of the\r\n             following conditions:\r\n\r\n               1. Symptoms that support the diagnosis of chronic angina and/or a history of an\r\n                  abnormal exercise response limited by angina and/or electrocardiograph (ECG)\r\n                  changes\r\n\r\n               2. a history of myocardial infarction and ST-T changes,\r\n\r\n               3. stenosis of more than 50 % in at least one major epicardial coronary artery, as\r\n                  shown by coronary angiography or computed tomography angiography,\r\n\r\n               4. Coronary heart disease confirmed by radionuclide angiocardiography;\r\n\r\n          4. Patients with moderate angina pectoris, which is defined as Grade II or III on the\r\n             Canadian Cardiovascular Society Angina Grading Scale.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients with severe complications that would complicate the condition, as assessed by\r\n             the investigator, including liver or renal dysfunction, severe cardiopulmonary\r\n             dysfunction, pulmonary hypertension, chronic obstructive pulmonary disease, a history\r\n             of epilepsy or cerebral haemorrhage.\r\n\r\n          2. Patients who were angina-free during the run-in period without taking any drug.\r\n\r\n          3. Patients who experienced myocardial infarction or who were classified as Grade IV on\r\n             the Canadian Cardiovascular Society Angina Grading Scale within the preceding 3\r\n             months.\r\n\r\n          4. Patients with chest pain that is caused by any other disease (e.g., acute myocardial\r\n             infarction, severe neurosis, menopausal syndrome or hyperthyroidism).\r\n\r\n          5. Patients with a history of drug-induced bleeding or a history of bleeding caused by\r\n             warfarin.\r\n\r\n          6. Patients with a history of haematopoietic disorder.\r\n\r\n          7. Patients who have had surgery within the previous 4 weeks or who have a haemorrhagic\r\n             tendency.\r\n\r\n          8. Women who are pregnant or lactating or who have a positive pregnancy test, or women\r\n             who have a menstrual period at baseline.\r\n\r\n          9. Patients who are participating in other trials or who have participated in other\r\n             trials within the past 3 months.\r\n\r\n         10. Patients with a history of allergy or with a known or suspected allergy to the study\r\n             drug.\r\n\r\n         11. Patients with a known or suspected history of alcohol or drug abuse within the past 2\r\n             years.\r\n\r\n         12. Patients with a mental disorder.\r\n\r\n         13. Family members or relatives of the study centre staff.\r\n\r\n         14. Inability to adhere to study procedures\r\n      ","sponsor":"Taizhou Fourth People's Hospital","sponsor_type":"Other","conditions":"Angina, Stable|Inflammation","interventions":[{"intervention_type":"Drug","name":"Drug: Dan-shen extract","description":"A kind of injection made from a kind of Chinese herb: salvia miltiorrhiza"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"200mg glugose added into 250ml 0.9% saline injection by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, using brown infusion tube for infusion."},{"intervention_type":"Other","name":"Other: Standard medical care","description":"Standard medical care is in accordance with China Guideline for the diagnosis and treatment of Chronic Stable Angina (2007)."}],"outcomes":[{"outcome_type":"secondary","measure":"carotid arterial intima-media wall thickness","time_frame":"Day0 and Day 60 after discharge"},{"outcome_type":"primary","measure":"Serum level of Lp-PLA2","time_frame":"up to Day 60 after discharge"},{"outcome_type":"secondary","measure":"The proportion of patients in each treatment group who had clinically significant change as defined by the angina-frequency score on the Seattle Angina Questionnaire","time_frame":"Day 0 and Day 60 after discharge"},{"outcome_type":"secondary","measure":"Canadian Cardiovascular Society (CCS) grading of angina pectoris","time_frame":"Day 0 and Day 60 after discharge"},{"outcome_type":"secondary","measure":"Change in the electrocardiogram (EKG)","time_frame":"Day 0 and Day 60 after discharge"},{"outcome_type":"secondary","measure":"Changes in the Serum Lipid, the high-sensitivity C-Reactive Protein(hs-CRP) and the Platelet Aggregation Rate","time_frame":"Day 0 and Day 60 after discharge"},{"outcome_type":"secondary","measure":"Incidence of new-onset major vascular events","time_frame":"up to 60 days after discharge","description":"Major adverse vascular events include ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction and vascular-related death."},{"outcome_type":"secondary","measure":"Incidence of severe hemorrhages","time_frame":"up to 60 days after discharge","description":"The definition of \"Severe hemorrhages\" is in accordance with the GUSTO bleeding criteria, including fatal intracranial hemorrhage (ICH), symptomatic intracerebral hemorrhage (sICH) or which could result in substantial hemodynamic compromise requiring treatment."},{"outcome_type":"secondary","measure":"Incidence of moderate hemorrhages","time_frame":"up to 60 days after discharge","description":"The definition of \"moderate hemorrhages\" is in accordance with the GUSTO bleeding criteria, which requires blood transfusion but not results in hemodynamic compromise."}]}
{"nct_id":"NCT02910635","start_date":"2016-09-19","phase":"Phase 1","enrollment":52,"brief_title":"A Study to Evaluate the Effect of Volanesorsen on Cardiac Repolarization Conducted in Healthy Volunteers","official_title":"A Randomized, Placebo-Controlled, Four-Period Crossover, Study to Evaluate the Effect of Volanesorsen on the QTc Interval Using a Therapeutic and Supra-Therapeutic Dose Compared With Placebo in Healthy Volunteers: a Thorough QT Study","primary_completion_date":"2016-12-20","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-12-20","last_update":"2017-07-28","description":"The primary objective of this study is to assess the corrected QT interval (QTc) effect of volanesorsen (ISIS 304801) administered as a 300 mg subcutaneous (SC) therapeutic and a 300 mg intravenous (IV; 2-hour infusion) supra-therapeutic dose relative to placebo in healthy adult male and female subjects.","other_id":"ISIS 304801-CS13","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Other","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Must have given written informed consent and be able to comply with all study\r\n             requirements\r\n\r\n          -  Males and females aged 18-55 at the time of informed consent\r\n\r\n          -  Females must be non-pregnant and non-lactating surgically sterile, post-menopausal or\r\n             if engaged in sexual relations of childbearing potential, using an acceptable\r\n             contraceptive method\r\n\r\n          -  Males must be surgically sterile, abstinent or using an acceptable contraceptive\r\n             method\r\n\r\n          -  The subject has a BMI of 19 to 32 kg/m^2 inclusive\r\n\r\n          -  Consumption of nicotine or nicotine-containing products for at least 6 months before\r\n             Screening\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of risk factors for Torsades de Pointes, unexplained syncope, known Long QT\r\n             Syndrome, heart failure, myocardial infarction, angina, or clinical significant\r\n             abnormal laboratory assessments including hypokalemia, hypocalcemia, hypercalcemia, or\r\n             hypomagnesemia\r\n\r\n          -  Abnormal screening ECG\r\n\r\n          -  Use of concomitant medications unless authorized by the Sponsor Medical Monitor\r\n\r\n          -  Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C\r\n             or chronic hepatitis B\r\n\r\n          -  Treatment with another Study Drug, biological agent, or device within one-month of\r\n             Screening\r\n\r\n          -  Tests positive for drugs of abuse or cotinine\r\n\r\n          -  Considered unsuitable for inclusion by the Principal Investigator\r\n      ","sponsor":"Ionis Pharmaceuticals, Inc.","sponsor_type":"Industry","conditions":"Abnormalities, Cardiovascular","interventions":[{"intervention_type":"Drug","name":"Drug: Moxifloxacin","description":"Moxifloxacin Hydrochloride 400 mg tablet administered orally, Single Dose"},{"intervention_type":"Drug","name":"Drug: Placebo"},{"intervention_type":"Drug","name":"Drug: Volanesorsen","description":"ISIS 304801 is supplied as 200mg of volanesorsen with 1.0mL of solution per vial"}],"outcomes":[{"outcome_type":"primary","measure":"Placebo corrected change from baseline in QTcF (corrected Frederica's CT Interval)","time_frame":"24 Hours","description":"ECG monitoring up to 24 hours post dose"},{"outcome_type":"secondary","measure":"Placebo corrected change from baseline heart rate (HR, PR and QRS)","time_frame":"24 Hours","description":"ECG monitoring 24 hours post dose"},{"outcome_type":"other","measure":"Volanesorse plasma pharmacokinetics (PK)","time_frame":"0 to 24 hours","description":"Area under the plasma concentration time curve from time 0 to 24 hours (AUC 0-24h)"}]}
{"nct_id":"NCT03181620","start_date":"2016-09-08","phase":"N/A","enrollment":200,"brief_title":"Sedation Administration Timing: Intermittent Dosing Reduces Time to Extubation","official_title":"Sedation Administration Timing: Intermittent Dosing Reduces Time to Extubation (SATIRE Trial): A Prospective, Randomized Cohort Study","primary_completion_date":"2019-03-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-04-30","last_update":"2019-01-09","description":"SATIRE is a prospective, randomized control trial assessing two methods of administration of intravenous sedation and narcotics in surgical patients requiring mechanical ventilation. Many hospitals use a continuous infusion method of administering these medications. The investigators hypothesize that intermittent, bolus/sliding-scale based administration will lead to less medication being given and subsequently decrease the amount of time on mechanical ventilation without compromising patient comfort or level of sedation. Patients are randomized into a control arm (continuous infusion) and a trial arm (sliding scale hourly bolus) using versed for sedation and fentanyl for pain medication. Inclusion criteria are surgical patients requiring mechanical ventilation, including trauma patients, post operative patients, etc. Primary end point is total time of mechanical ventilation in each arm. Secondary end points are amount of medication given, time in ICU, time to discharge. Mortality and adverse events in both arms are recorded and reported to the Institutional Review Board for monitoring.","other_id":"AbingtonMH","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Un-blinded, Prospective, Randomized Control Trial","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Mechanical ventilation in the Surgical ICU.\r\n\r\n          -  Age >18 years old\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Use of dexmedetomidine (Precedex)\r\n\r\n          -  Use of neuromuscular blocking agents\r\n\r\n          -  Use of propofol >24 hours\r\n\r\n          -  Discontinuation of midazolam as sedative (i.e., switching to propofol or\r\n             dexmedetomidine)\r\n\r\n          -  Therapeutic hypothermia\r\n\r\n          -  Patients that do not require sedatives/narcotics while intubated (i.e. coma, traumatic\r\n             brain injury)\r\n\r\n          -  Pregnancy\r\n\r\n          -  Prisoners\r\n\r\n          -  Patients with target RASS of -3 to -5 (Deep Sedation)\r\n      ","sponsor":"Abington Memorial Hospital","sponsor_type":"Other","conditions":"Respiration, Artificial|Postoperative Pain|Postoperative Complications","interventions":[{"intervention_type":"Other","name":"Other: Intermittent Dosing of Medication","description":"Typical sedative/narcotic medication administered for sedation while mechanically ventilated is given in an intravenous intermittent bolus fashion rather than a continuous intravenous drip."}],"outcomes":[{"outcome_type":"primary","measure":"Total Time Mechanically Ventilated","time_frame":"Two years","description":"Total time that the patient requires mechanical ventilation"},{"outcome_type":"secondary","measure":"ICU Length of Stay","time_frame":"Two Years","description":"Total time in ICU"},{"outcome_type":"secondary","measure":"Hospital Length of Stay","time_frame":"Two Years","description":"Total time in Hospital"},{"outcome_type":"secondary","measure":"Amount of Sedative Agent Given","time_frame":"Two Years","description":"Total amount of sedative given in milligrams"},{"outcome_type":"secondary","measure":"Amount of Narcotic Agent Given","time_frame":"Two Years","description":"Total amount of narcotic agent given in micrograms"},{"outcome_type":"secondary","measure":"Time at target level of sedation (RASS) in Both Arms","time_frame":"Two Years","description":"Time at target level of sedation (RASS) in Both Arms"},{"outcome_type":"secondary","measure":"Time at target level of pain control (CPOT) in Both Arms","time_frame":"Two Years","description":"Time at target level of pain control (CPOT) in Both Arms"}]}
{"nct_id":"NCT04188821","start_date":"2016-09-01","phase":"N/A","enrollment":124,"brief_title":"Reduction of Seroma and Improvement of QoL in Breast Reconstruction With Tissue Expander","official_title":"Reduction of Seroma and Improvement of Quality of Life After Early Drain Removal in Immediate Breast Reconstruction With Tissue Expander. Preliminary Report of a Randomized Controlled Study","primary_completion_date":"2018-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-12-31","last_update":"2019-12-10","description":"The experimental hypothesis of this randomized controlled study was to demonstrate that early drain removal in patients who underwent immediate breast reconstruction with tissue expander is a safety procedure to improving clinical outcomes and quality of life (QoL). The mechanism of action underlying the proposed approach was intuitive. The early drain removal allows to: 1) avoid continuous seroma development caused by active suction of drain (stopping the circle \"drain itself may perpetuate the drainage\" with vacuum mechanism); 2) reduce the risks connected to \"foreign body reaction\" as tissue inflammation and infection; 3) improve QoL reducing pain, length of hospital stay and limitations of daily activities.","other_id":"01/2019","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  SNS (skin nipple sparing) or SS (skin sparing) mastectomy for breast cancer and\r\n             immediate positioning of breast expander (without mesh) with placement of suction\r\n             drain, regardless of TNM classification\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  skin reducing mastectomy, reconstruction with flap, direct to implant reconstruction\r\n             (with or without mesh or ADM) and axillary dissection\r\n      ","sponsor":"University of Foggia","sponsor_type":"Other","conditions":"Safety Issues|Quality of Life","interventions":[{"intervention_type":"Procedure","name":"Procedure: breast drain removal","description":"Investigators remove the drains when the suction drain flow was less than 30 ml/day for at least 2 days or at discharge, with no further signs of infection, fluid collection or impaired wound healing (\"complicated\", see below). Ultimately, we removed drains 3 weeks postoperatively (21 days post op) even if the flow was higher than 30 ml/day. However, leakage or severe patient discomfort led to immediate drain removal at any time during postoperative care."}],"outcomes":[{"outcome_type":"primary","measure":"total fluid volume (ml)","time_frame":"21 days","description":"sum of drain volumes and volume of seroma aspirations if needed"},{"outcome_type":"primary","measure":"days with drainage","time_frame":"21 days"},{"outcome_type":"primary","measure":"days of seroma formation","time_frame":"21 days","description":"period that drain or seroma aspiration is needed in days after surgery"},{"outcome_type":"primary","measure":"time until wound healing (days)","time_frame":"21 days"},{"outcome_type":"primary","measure":"infection (yes or not)","time_frame":"21 days","description":"defined as the appearance of local signs/symptoms as erythema, edema, induration, increased pain, and a change in drainage to a purulent nature and fever, confirmed by swabs"},{"outcome_type":"primary","measure":"complicated wound healing (yes or not)","time_frame":"21 days","description":"unclosed wound 3 weeks postoperatively"},{"outcome_type":"secondary","measure":"pain (using Visual Analogic Score scale to measure intensity)","time_frame":"21 days","description":"The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between \"no pain\" (0) and \"worst pain.\" (10)"},{"outcome_type":"secondary","measure":"disturbance in quality of sleep (yes or not)","time_frame":"21 days"},{"outcome_type":"secondary","measure":"limitation in personal care, daily activities and social life (yes or not)","time_frame":"21 days"},{"outcome_type":"secondary","measure":"disturbance in mobility (yes or not)","time_frame":"21 days","description":"mobility as walking, running, driving"}]}
{"nct_id":"NCT02855424","start_date":"2016-08-31","phase":"N/A","enrollment":90,"brief_title":"The Effect of Leg Cycling Exercise Program at Low or Moderate Intensity for Individuals With Subacute Stroke","official_title":"The Effect of Leg Cycling Exercise Program at Low or Moderate Intensity for Individuals With Subacute Stroke","primary_completion_date":"2019-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2020-12-31","last_update":"2016-08-05","description":"Poor cardiopulmonary endurance is observed in individuals with acute stroke, even in chronic. In addition, the poor fitness may obstacle activities of daily life, decrease activities of autonomic system, and increase risks of recurrent, therefore, the cardiopulmonary endurance training should be included into the early-stage rehabilitation program. The ergocycling training could improve cardiopulmonary endurance for individuals with stroke. Moreover, the low-intensity exercise training can increase the willingness, and it is safer than the moderate-intensity exercise training. However, it needs to be evaluated whether the low-intensity exercise training can bring sufficient benefits, compared to the moderate-intensity exercise training. Objectives of the study is to compare the exercise benefits between the low-intensity and moderate-intensity exercise training, and then these would offer optimal exercise prescription and considerations in clinical practice.","other_id":"KUMHIRB-F(II)-2016002","allocation":"Randomized","intervention_model":"Factorial Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":40,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. the first-ever stroke\r\n\r\n          2. period of ischemic stroke onset is longer than two weeks, and less than six months,\r\n             and the doctors agree with exercise training\r\n\r\n          3. unilateral hemiplegia\r\n\r\n          4. no obvious deficits of cognition. Scores of three items in the National Institutes of\r\n             Health Stroke Scale are zero\r\n\r\n          5. be willing to join this study and give their consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. aphasia\r\n\r\n          2. orthopedic problems (severe arthritis), neurologic injury (eg. peripheral nerve\r\n             injury) that can interfere with movement of the lower limb, or cannot sit\r\n             independently\r\n\r\n          3. with pace maker, severe cardiac arrhythmia, or heart failure\r\n\r\n          4. abnormal electrocardiography in rest, is not suitable for exercise tolerance test\r\n             according to the American College of Sports Medicine guidance, for example, the\r\n             atrioventricular block (AV block).\r\n      ","sponsor":"Kaohsiung Medical University Chung-Ho Memorial Hospital","sponsor_type":"Other","conditions":"Stroke","interventions":[{"intervention_type":"Other","name":"Other: the low-intensity exercise group","description":"Totally 20-time training, frequency 2-6 time/week, total 20 times."},{"intervention_type":"Other","name":"Other: the moderate-intensity exercise group","description":"Totally 20-time training, frequency 2-6 time/week,total 20 times."}],"outcomes":[{"outcome_type":"primary","measure":"changed value of symptom-limit exercise tolerance tests","time_frame":"Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up","description":"One doctor and one therapist monitor the test. EKG and self-report are used."},{"outcome_type":"secondary","measure":"changed activity of autonomic nervous system (ANS)","time_frame":"Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up","description":"The frequency domain analysis (measure unit of activity of ANS) is used in two conditions (sit and calculate math; 5 minutes/each condition)."},{"outcome_type":"secondary","measure":"10-meter walking test","time_frame":"Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up","description":"Time of performing the 10 meters is measured."},{"outcome_type":"secondary","measure":"changed score of the Barthel index","time_frame":"Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up","description":"Using Barthel index questionnaire"},{"outcome_type":"secondary","measure":"changed score of the Stroke-Specific Quality of Life Scale (SSQOL)","time_frame":"Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up","description":"Using SSQOL questionnaire"},{"outcome_type":"secondary","measure":"changed value of the Fugl-Meyer Assessment Lower Extremity (FMA-LE)","time_frame":"Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up","description":"Measure items of FMA-LE"},{"outcome_type":"secondary","measure":"changed score of Multi-dimensional Fatigue Inventory","time_frame":"Baseline, 4 weeks to 10 weeks for exercise completion, one-month follow-up","description":"Using Multi-dimensional Fatigue Inventory questionnaire"},{"outcome_type":"secondary","measure":"performance of cycling","time_frame":"4 weeks to 10 weeks for exercise completion","description":"the maximal power is recorded by a chip of the training bike continually during each training;2-6 times/week, total 20 times training."}]}
{"nct_id":"NCT02828774","start_date":"2016-08-31","enrollment":30,"brief_title":"Peptide-drug-conjugates for Personalized, Targeted Therapy of Chronic Lymphocytic Leukemia","official_title":"Peptide-drug-conjugates for Personalized, Targeted Therapy of Chronic Lymphocytic Leukemia","primary_completion_date":"2019-06-30","study_type":"Observational","rec_status":"Unknown status","completion_date":"2020-06-30","last_update":"2016-07-12","description":"Using phage libraries extensively pre-absorbed on a series of normal cell types, we will isolate phage specifically internalized by B-CLL cells from newly diagnosed and untreated CLL patients. Peptide sequences are then derived by Next Generation Sequencing (NGS). NGS-based studies are contributing to an improved understanding of cancer heterogeneity in order to tailor treatment to patients based on the individual makeup of their tumor. However the use of NGS to derive phage displayed peptide sequences is so far rare (22). Traditionally, after exposure to a target and recovery by elution, the phage clones are isolated by titration on bacterial lawns. It is technically demanding and labour intensive to select and analyze more than about 15 of the sometimes thousands clones recovered. Therefore information on other potentially important sequences is missed. NGS allows sequencing of the entire recovered phage pool and provides far more detailed bioinformatic analyses of peptide sequences or motifs. RNA from the CLL cells is used for RNA-seq expression sequencing. The wide application of NGS in combination with bioinformatics tools has begun to revolutionize cancer research, diagnosis and therapy. The peptide and RNA sequencing data will afford bioinformatic testing of correlations of exome expression and clinical parameters with the pattern of peptide sequences internalized by CLL cells of different patients. This information is crucial to answering questions 1, 2 and 3 discussed on page 1 above. The results of this analysis will probably not allow identification of specific receptors targeted by the peptides. The aim at this stage of the research is to identify candidate targeting peptides. Once identified, further research will be needed to identify the receptors to which they bind. Regarding question 4, there is currently very little published information on the therapeutic potential of PDCs in leukemia. Using two peptides we have isolated that target murine A20 leukemic cells, we will prepare multi-drug PDCs (using technology we have developed) and in an animal model, test their ability to enhance the survival and quality of life of CLL bearing animals.","other_id":"2015050","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","population":"CLL patients","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  CLL patients intended to receive treatment in 30 days from recruitment to the study..\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  CLL patient not about to receive treatment in 30 day of recruitment to the study.\r\n      ","sponsor":"Assuta Medical Center","sponsor_type":"Other","conditions":"CLL","interventions":[{"intervention_type":"Other","name":"Other: there will be no intervention.","description":"this study is observational, procedure are done in vitro and on animal models."}],"outcomes":[{"outcome_type":"primary","measure":"Cytotoxicity of PDCs and free drug will be assessed by calculating % Growth Inhibition of treated versus untreated cells.","time_frame":"36 months"}]}
{"nct_id":"NCT02847858","start_date":"2016-08-31","phase":"N/A","enrollment":1360,"brief_title":"Health-E You: Reducing Unintended Pregnancies Among Hispanic Adolescents","official_title":"Health-E You: Reducing Unintended Pregnancies Among Hispanic Adolescents Using a Computer-based Intervention","primary_completion_date":"2019-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-01-31","last_update":"2019-10-23","description":"Health -E-You is an interactive, individually tailored computer application (App) that was developed to educate adolescent girls about contraceptive methods and assist them in selecting a contraceptive method that meets their individual needs. The goal is to reduce disparities in unintended pregnancy rates among Hispanic adolescent females. The App was designed in close collaboration with clinicians and Hispanic adolescents. Health-E You was designed to be used in conjunction with a clinical encounter to prime both the patient and provider prior to the face-to-face visit to facilitate the discussion and provision of appropriate contraception. It is founded on key principles of Social Cognitive Theory. Through an interactive approach, Health-E-You assesses the users' sexual health risks, knowledge and contraceptive use history and preferences to facilitate a sense of agency and self-efficacy around selecting an effective contraceptive method. First, the user selects their preferred language (English or Spanish) and according to the selected language, the App provides a brief description of the module and consents the user to participate. It then assesses sexual health knowledge using an interactive truth vs. myth game. Correct answers to the truth vs. myth statements are then presented to the user as short, easy-to-read explanations. Next, the App assesses the user's individual contraceptive needs and preferences. The user is also screened for possible medical contraindications to contraceptive methods. Based on the user's input, the App provides individually tailored messaging and recommendations for contraceptive methods according to the user's own timeline for childbearing and their lifestyle preferences, past experiences and needs. The recommendations are presented on a visual continuum of effective contraceptive options based on desired duration of action and efficacy. Users then have the option to learn more about the recommended method(s) and they also have the option to learn more about any of the contraceptive options. Evidence-based contraceptive information is presented in a user-friendly format that includes YouTube style videos. Users can select to view brief video vignettes that feature clinicians who provide additional information about the method of interest and/or videos of diverse young women who discuss their experiences with each of the contraceptive methods. At the end of the App, adolescents are asked to select the method (s) they are most interested in using. They are also encouraged to use condoms to protect against sexually transmitted infections (STIs) and provided information about emergency contraception. Users can review a summary of a key information gathered from the App and are offered the opportunity to share that information with their clinician so that the clinician can better support the adolescent in selecting and using an effective and appropriate contraceptive method. The objective of this study is to evaluate the effectiveness of Health-E You on its ability to address disparities in contraceptive knowledge, access and utilization among Hispanic adolescents. The long term goal is to reduce the incidence of unprotected sexual intercourse (and associated unintended pregnancies and STIs) over time. A total of 14 School-Based Health Centers (SBHCs) affiliated with the Los Angeles Unified School District, will be randomized, with equal chance, to use the Health-E You App or to provide usual care (without the App). A total of 1400 Hispanic adolescents will be selected to participate in the study (700 at intervention clinics and 700 at the control clinics). The investigators hypothesize that adolescents who use the Health-E You App will have greater sexual health knowledge and will be more likely to use effective contraceptive than adolescent who do not use the App. The investigators will also evaluate the effectiveness of the App on its ability to improve the effectiveness and efficiency of the health visit. Participants will be asked to complete follow-up surveys immediately following the clinical encounter and at three and six months after the clinical encounter. The ultimate goal of this study is address health disparities in the use of effective contraceptives and ultimately reduce the incidence of unintended pregnancies and STIs among at-risk Hispanic adolescent girls.","other_id":"AD-1502-27481","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"Female","minimum_age":14,"maximum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Female 14-18 years of age Hispanic/Latina English or Spanish-speaker Has had sexual\r\n        intercourse\r\n\r\n        Exclusion Criteria:\r\n\r\n        Currently pregnant Currently using an intrauterine device or implant contraceptive method\r\n        Male Under 14 or over 19 years of age Not sexually active Non-Hispanic / Latina\r\n      ","sponsor":"University of California, San Francisco","sponsor_type":"Other","conditions":"Unprotected Sex|Unsafe Sex","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Health-E You: a computer-based intervention to improve the use of effective contraception among Hispanic adolescents","description":"School-based health centers which were randomized into the intervention arm will use the Health-E You App (n=7 clinics)."}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of Participants Who Report Using a Non-barrier Method of Birth Control in the Prior 3 Months (Aim 3b)","time_frame":"Baseline, 3 months, 6 months","description":"Recorded via self-administered online survey"},{"outcome_type":"primary","measure":"Contraception Use Self-efficacy Scale Score (Aim 1b)","time_frame":"Pre-visit Baseline, Post-visit Follow-up (48 hours after Baseline)","description":"The 3-item attitude scale assessing perceived ability to choose and use contraception was self-administered in an online survey; each item scored on a 0=not at all confident to 10=completely confident scale; scale score is the sum of the 3 items scores, range 0 - 30 (higher score=greater self-efficacy)"},{"outcome_type":"primary","measure":"Contraception Use Self-efficacy Scale Score (Aim 1c)","time_frame":"Baseline, 3 months, 6 months","description":"The 3-item attitude scale assessing perceived ability to choose and use contraception was self-administered in an online survey; each item scored on a 0=not at all confident to 10=completely confident scale ; scale score is the sum of the 3 items scores (range 0-30); higher score=greater self-efficacy"},{"outcome_type":"secondary","measure":"Number of Correct Answers to 7-item Contraception Knowledge Measure (Aim 1a)","time_frame":"Immediate pre-app (Baseline), Immediate post-app (< 1 hour)","description":"The same measure was self-administered in an online survey immediately prior to using the Health-E You app (the intervention) and then immediately after app use. The Health-E You Knowledge Scale is a 7-item true/false format with a range of 0-7, a higher score indicates a better outcome."},{"outcome_type":"secondary","measure":"Percentage of Participants Who Report Discussing Birth Control With Health Care Provider at Visit (Aim 2b)","time_frame":"Post-visit Follow-up (48 hours after Baseline)","description":"The single yes/no item was self-administered in an online survey"},{"outcome_type":"secondary","measure":"Percentage of Participants Who Receive or Make an Appointment to Receive or Receive a Prescription for a Non-barrier Method (Aim 3a)","time_frame":"Post-visit Follow-up","description":"Recorded via self-administered online survey"},{"outcome_type":"secondary","measure":"Post-study Assessment of Providers' Rating of How the Health-E You APP Improves the Effectiveness of the Clinical Encounter for Patients: App Helps Patients Engage in Contraception Decision Making (Aim 2a1)","time_frame":"Post-study completion","description":"Provider ratings of whether the App improves the effectiveness of the clinical encounter for patients, using a Likert scale (options 1- strongly disagree to 5- strongly agree); then dichotomized into agrees versus neutral/disagrees."},{"outcome_type":"secondary","measure":"Post-study Assessment of Provider Ratings of Whether the Health-E You APP Helps Clinicians Provide Individually Tailored Discussion of Contraception Options (Aim 2a2)","time_frame":"Post-study completion","description":"Provider ratings of whether the App helps clinicians provide more individually tailored discussion of contraception options, using a Likert scale (options 1- strongly disagree to 5- strongly agree); then dichotomized into agrees versus neutral/disagrees."},{"outcome_type":"secondary","measure":"Post-study Assessment of Provider Ratings of Whether the Health-E You APP Improves the Effectiveness of the Clinical Encounter by Integrating Reproductive Health Into All Visits (Aim 2a3)","time_frame":"Post-study completion","description":"Provider ratings of whether the App improves effectiveness of the clinical encounter by integrating reproductive health into all visits, using a Likert scale (options 1- strongly disagree to 5- strongly agree); then dichotomized into agrees versus neutral/disagrees."},{"outcome_type":"secondary","measure":"Post-study Assessment of Provider Ratings of Whether the Health-E You APP Makes Clinic Schedule Run Behind (Aim 2a4)","time_frame":"Post-study completion","description":"Provider ratings of whether the App makes clinic schedules run behind, using a Likert scale (options 1- strongly disagree to 5- strongly agree); then dichotomized into agrees versus neutral/disagrees."},{"outcome_type":"secondary","measure":"Adolescent Assessment of Health-E You App Benefits: Helped me Choose a Birth Control Method (Aim 2a5)","time_frame":"Immediate Follow-up","description":"Response to query about agreement with App benefits on 5 point Likert scale (1-strongly disagree to 5- strongly agree); dichotomized into agree versus neutral/disagree"},{"outcome_type":"secondary","measure":"Adolescent Assessment of Health-E You App Benefits: Gave me Useful Information About Birth Control (Aim 2a6)","time_frame":"Immediate Follow-up","description":"Response to query about agreement with App benefits on 5 point Likert scale (1-strongly disagree to 5- strongly agree); dichotomized into agree versus neutral/disagree"},{"outcome_type":"secondary","measure":"Adolescent Assessment of Health-E You App Benefits: Helped me Talk With my Health Care Provider About Birth Control (Aim 2a7)","time_frame":"Immediate Follow-up","description":"Response to query about agreement with App benefits on 5 point Likert scale (1-strongly disagree to 5- strongly agree); dichotomized into agree versus neutral/disagree"},{"outcome_type":"secondary","measure":"Adolescent Assessment of Health-E You App Benefits: Improved the Quality of my Visit With my Health Care Provider (Aim 2a8)","time_frame":"Immediate Follow-up","description":"Response to query about agreement with App benefits on 5 point Likert scale (1-strongly disagree to 5- strongly agree); dichotomized into agree versus neutral/disagree"}]}
{"nct_id":"NCT02832856","start_date":"2016-08-31","phase":"N/A","enrollment":1180,"brief_title":"Testing the Effectiveness of the Full and Abridged Relationship Smarts Curriculum for 9th Grade Students","official_title":"Testing the Effectiveness of the Full and Abridged Versions of the Relationship Smarts Curriculum for 9th Grade Students","primary_completion_date":"2019-04-30","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2021-08-31","last_update":"2020-05-04","description":"This evaluation will test the program effectiveness of a relationship education program (Relationship Smarts PLUS)and an abridged version of the program to 9th Grade Students on outcomes of knowledge. It will test 1) whether the Relationship Smarts (RS) Curriculum is more effective than a control curriculum of job-readiness programming, and 2) whether an abridged 8-lesson version of the RS Curriculum can be as effective as the full 12-lesson version.","other_id":"MPR-500098-MTC","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":11,"maximum_age":16,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  high school students in 9th grade health classes\r\n\r\n          -  must be enrolled in one of the targeted health classes\r\n\r\n          -  permission from a parent or guardian to participate in both the program and the\r\n             evaluation\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  non-students\r\n\r\n          -  students in other grades of high school\r\n\r\n          -  students not enrolled in health class\r\n\r\n          -  students without parental permission to participate\r\n      ","sponsor":"Mathematica Policy Research, Inc.","sponsor_type":"Other","conditions":"Attitudes|Knowledge","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Healthy Relationship Education","description":"RS+ is a widely-implemented healthy relationship education curriculum that aligns with the Georgia Department of Education performance standards in health education. The full curriculum features 12 lessons covering such topics as healthy relationships, dating violence prevention, communication skills, conflict management, and decision making."},{"intervention_type":"Behavioral","name":"Behavioral: Job Readiness Curriculum","description":"Beginning to Work it Out (BWIO) assists youth who are preparing for first-time employment. Topics include recognizing how personal beliefs and behaviors may be perceived in the workplace, as well as \"soft skills\" such as emotional self-management and problem-solving skills."}],"outcomes":[{"outcome_type":"primary","measure":"Desire to avoid teen pregnancy","time_frame":"one year after random assignment","description":"series of three separate continuous variables (range: 1 to 4)"},{"outcome_type":"primary","measure":"Perceived general relationship skills","time_frame":"one year after random assignment","description":"Six-item scale (range: 1 to 4)"},{"outcome_type":"primary","measure":"Perceived conflict management skills","time_frame":"one year after random assignment","description":"Five-item scale (range: 1 to 4)"},{"outcome_type":"primary","measure":"Disapproval of teen dating violence","time_frame":"one year after random assignment","description":"Twelve-item scale (range: 1 to 4)"},{"outcome_type":"primary","measure":"Constraining beliefs about marriage","time_frame":"one year after random assignment","description":"Series of three separate continuous variables (range: 1 to 4)"},{"outcome_type":"primary","measure":"Knowledge of pregnancy and STIs","time_frame":"one year after random assignment","description":"Continuous index variable: sum of correct responses to five true/false statements"}]}
{"nct_id":"NCT02886975","start_date":"2016-08-31","phase":"N/A","enrollment":100,"brief_title":"Effects of Low Protein Diet in Preventing the Progression of Chronic Kidney Disease(CKD)---a Prospective Study","official_title":"Effects of Low Protein Diet Supplemented Keto-/Amino Acid in Preventing the Progression of Chronic Kidney Disease(CKD)","primary_completion_date":"2019-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-12-31","last_update":"2019-04-19","description":"The purpose of this study is to determine whether low protein diet and very low protein diet supplemented keto-/amino acid is effective in preventing the progression of chronic kidney disease (CKD , stage 2 to 5).","other_id":"YYK-2016001","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria: Patients with chronic kidney disease in stage 2 to 5 (GFR<60\r\n        ml/min/1.73m2) receiving conservative treatment for CKD\r\n\r\n        Exclusion Criteria: None\r\n      ","sponsor":"The Third Xiangya Hospital of Central South University","sponsor_type":"Other","conditions":"Renal Insufficiency, Chronic","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: low protein diet plus -keto acid","description":"0.4-0.6g of proteins per kilo of body weight per day, supplemented with -keto acid tablets"}],"outcomes":[{"outcome_type":"primary","measure":"changes in glomerular filtration rate","time_frame":"1 year","description":"Nutritional status, evaluated by nutrition risk screening (NRS 2002), at the start and during the 1st year of investigators' intervention."},{"outcome_type":"secondary","measure":"Compliance to diet","time_frame":"1 year","description":"Compliance to diet, defined by the participants' persistence in low protein diet, by outpatient follow-up and telephone follow-up."},{"outcome_type":"secondary","measure":"Nutritional status","time_frame":"1 year","description":"Nutritional status, evaluated by nutrition risk screening (NRS 2002), at the start and during the 1st year of investigators' intervention."}]}
{"nct_id":"NCT01934920","start_date":"2016-08-31","enrollment":500,"brief_title":"Identifying Patients With Unrecognized Treatable Diabetic Macular Edema","official_title":"Identifying Patients With Unrecognized Treatable Diabetic Macular Edema","primary_completion_date":"2019-05-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2019-05-31","last_update":"2019-02-07","description":"This trial will assess the incidence of new and/or undiagnosed diabetic macular edema (DME) in diabetic patients that undergo a DME screening exam. The screening exam will consist of medical history, Electronic ETDRS visual acuity assessment, SD-OCT and color fundus photography","other_id":"Elman-01","observational_model":"Other","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"Patients identified through medical records or admitted into Franklin Square Hospital with\r\n        a history of diabetes","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Ability to provide written informed consent and comply with study assessments for the\r\n             full duration of the study\r\n\r\n          -  Age > 18 years\r\n\r\n          -  Patient related considerations\r\n\r\n          -  Patients with diabetes mellitus\r\n\r\n          -  Disease related considerations\r\n\r\n          -  Diabetes mellitus\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior admission screening within twelve months.\r\n\r\n          -  Inability to sit for evaluation\r\n      ","sponsor":"Elman Retina Group","sponsor_type":"Other","conditions":"Diabetic Macular Edema","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Assess the incidence of new and/or undiagnosed diabetic macular edema.","time_frame":"1 day (Patients are only seen once for assessments)","description":"This trial will assess the incidence of new and/or undiagnosed diabetic macular edema (DME) in diabetic patients that undergo a DME screening exam. The screening exam will consist of medical history, Electronic ETDRS visual acuity assessment, SD-OCT and color fundus photography"},{"outcome_type":"secondary","measure":"Streamlining and identification of patients at risk of diabetic macular edema","time_frame":"1 day (Patients only seen once for assessments)","description":"Establish methods for streamlining screening and identification of patients at risk.\r\nEstablish methods for referral for treatment of patients identified with vision threatening diabetic retinopathy."}]}
{"nct_id":"NCT02847676","start_date":"2016-08-31","enrollment":40,"brief_title":"Differences in Peritoneal Stem Cells in Women With and Without Adhesions After Gynaecological Surgery","official_title":"Differences in Peritoneal Stem Cells in Women With and Without Adhesions After Gynaecological Surgery","primary_completion_date":"2017-01-31","study_type":"Observational [Patient Registry]","rec_status":"Unknown status","completion_date":"2017-08-31","last_update":"2016-07-28","description":"Our study aims to characterise a possible pluripotent cell population in the abdomen responsible for peritoneal adhesions. We therefore want to take samples from women undergoing planned laparoscopic surgery with and without adhesions, isolate the cells and characterise them for markers of pluripotency.","other_id":"PHDW-005","sampling_method":"Non-Probability Sample","gender":"Female","minimum_age":18,"population":"All patients undergoing scheduled pelvic gynecological surgical treatment, at the\r\n        Gynecology Department of Pius Hospital, Oldenburg.","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Woman equal to and above 18 years of age.\r\n\r\n          2. Woman with a negative pregnancy test at the time of recruitment, and sufficient\r\n             contraception from time of\r\n\r\n          3. Woman with any gynecological pathology requiring scheduled pelvic gynecological\r\n             surgery, either laparotomy or laparoscopy.\r\n\r\n          4. Woman without primary peritoneal disease.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Woman with a primary peritoneal pathology.\r\n\r\n          2. Emergency surgery\r\n\r\n          3. Patients under systemic immunosuppressive therapy in the previous 6 months\r\n\r\n          4. Patients with current intra-abdominal or pelvic abscess or systemic infection\r\n\r\n          5. Pregnant woman\r\n\r\n          6. Simultaneous participation in another clinical trail\r\n      ","sponsor":"Pius-Hospital Oldenburg","sponsor_type":"Other","conditions":"Peritoneal Adhesions","interventions":[{"intervention_type":"Procedure","name":"Procedure: Tissue sample donation","description":"Patients undergo planned gynaecological surgery. Tissue samples, which are routinely taken, are donated."}],"outcomes":[{"outcome_type":"primary","measure":"Pluripotency markers (Sox2, Nanog, Klf 4, Oct 3/4)","time_frame":"at least 10","description":"days since previous surgery"}]}
{"nct_id":"NCT01728987","start_date":"2016-08-31","phase":"Phase 2","enrollment":0,"brief_title":"The Significance of Vitamin D Storage in Adipose Tissue","official_title":"The Significance of Vitamin D Storage in Adipose Tissue","primary_completion_date":"2018-12-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2019-02-28","last_update":"2016-11-15","description":"The study will examine the role of adipose tissue in vitamin D physiology, particularly its role as a depot. the study is randomized double blind and placebo controlled.","other_id":"TromsEndo-2012-1","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  healthy subjects\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  hypercalcemia\r\n\r\n          -  pregnancy\r\n\r\n          -  women without safe contraception\r\n      ","sponsor":"University of Tromso","sponsor_type":"Other","conditions":"Obesity","interventions":[{"intervention_type":"Drug","name":"Drug: cholecalciferol","description":"as in arm description"},{"intervention_type":"Drug","name":"Drug: placebo","description":"capsule looking identical to the cholecalciferol capsule"}],"outcomes":[{"outcome_type":"primary","measure":"vitamin D in adipose tissue biopsies","time_frame":"12 months"},{"outcome_type":"secondary","measure":"rate of decline of 25ohd in serum","time_frame":"12 months"}]}
{"nct_id":"NCT02749617","start_date":"2016-08-09","phase":"Phase 2","enrollment":2,"brief_title":"A Pilot Study Investigating Apixaban and Dexamethasone InterAction in Multiple Myeloma","official_title":"A Pilot Study Investigating Apixaban and Dexamethasone InterAction in Multiple Myeloma","primary_completion_date":"2018-01-03","study_type":"Interventional","rec_status":"Terminated","completion_date":"2019-03-28","last_update":"2021-08-23","description":"This pilot study will investigate the impact of dexamethasone (DEX) on anti-Xa levels in participants taking apixaban 2.5 mg twice a day by mouth (PO BID). Investigators propose a prospective, cohort study of 24 participants with multiple myeloma, in whom a lenalidomide-dexamethasone (LEN-DEX)-based myeloma treatment regimen is indicated. Eligible participants will initiate thromboprophylaxis with apixaban prior to starting their DEX-containing regimen and continue until the end of cycle 3. Anti-Xa levels, D-Dimer and plasma drug concentration will be measured. This pilot study looks to investigate this potential interaction between apixaban and dexamethasone to see if it warrants further investigation in a larger study. The sample size of 24 provides 90% power to detect a primary outcome of  50% reduction in peak anti-Xa levels from baseline. Secondary outcomes include changes in plasma apixaban levels, D-dimer, and symptomatic venous thromboembolism (VTE) and bleeding during a 3-month treatment period.","other_id":"H14-01652","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":19,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with diagnosis of multiple myeloma according to criteria of the International\r\n             Myeloma Working Group\r\n\r\n          -  Patients in whom a LEN-DEX-based treatment regimen is indicated\r\n\r\n          -  Adult patients  19 years of age who are able to freely provide informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Concomitant antiplatelet or anticoagulant use\r\n\r\n          -  Calculated creatinine clearance < 30 mL/min by Cockcroft-Gault formula\r\n\r\n          -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times upper\r\n             limit of normal (ULN)\r\n\r\n          -  Total bilirubin > 2 x ULN\r\n\r\n          -  Thrombocytopenia < 50 x 10 gigalitres (Gl)\r\n\r\n          -  High bleeding risk or spontaneously prolonged prothrombin time or activated partial\r\n             thromboplastin time > 1.5 x ULN\r\n\r\n          -  Body weight <50 or >120 kg\r\n\r\n          -  Concomitant use of CYP3A4 or p-glycoprotein inducers or inhibitors\r\n\r\n          -  Use of Ginkgo biloba or St. John's Wort within 14 days before first dose of study drug\r\n\r\n          -  Dexamethasone use within last 3 months\r\n\r\n          -  Women of Childbearing potential without proper contraceptive measures, pregnancy or\r\n             breast feeding\r\n\r\n          -  Life expectancy less than 3 months\r\n\r\n          -  Inability to swallow or issues with malabsorption\r\n\r\n          -  Any other medical, social, logistical, geographical or psychological factors, which in\r\n             the opinion of the investigator, would prohibit follow-up, compliance and study\r\n             completion\r\n      ","sponsor":"University of British Columbia","sponsor_type":"Other","conditions":"Anti-Xa Activity","interventions":[{"intervention_type":"Drug","name":"Drug: apixaban","description":"2.5 mg PO BID"}],"outcomes":[{"outcome_type":"primary","measure":"Anti Xa Activity","time_frame":"3 months","description":"serial anti Xa activity"},{"outcome_type":"secondary","measure":"Plasma Apixaban Levels","time_frame":"3 months","description":"Due to lack of enrollment, plasma apixaban levels were not analyzed"}]}
{"nct_id":"NCT02748824","start_date":"2016-07-31","enrollment":5996,"brief_title":"Five-year Incidence of Age-related Macular Degeneration in the Central Region of Portugal","official_title":"Five-year Incidence of Age-related Macular Degeneration in the Central Region of Portugal","primary_completion_date":"2017-09-18","study_type":"Observational","rec_status":"Completed","completion_date":"2017-10-31","last_update":"2017-11-09","description":"To assess the five-year incidence of AMD in a population from the central region of Portugal, previously phenotypically characterized.","other_id":"4C-2016-09","observational_model":"Other","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":60,"population":"The study population will consist of male and female subjects who have participated and\r\n        phenotyped in the Epidemiologic Coimbra Eye Study (NTC01298674).\r\n\r\n        It is expected to recruit up to a total of 5.996 subjects, that is up to 2.975 subjects\r\n        from the Mira Healthcare Unit and up to 3.021 subjects from the Lous Healthcare Unit.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subjects who participated in the Epidemiologic Coimbra Eye Study (NCT01298674) and\r\n             that were phenotyped;\r\n\r\n          -  Subjects capable of understanding the information about the study and to give their\r\n             informed consent to enter the study;\r\n\r\n          -  Subjects willing and able to comply with the study procedures.\r\n\r\n        Exclusion Criteria:\r\n\r\n        - Not applicable\r\n      ","sponsor":"Association for Innovation and Biomedical Research on Light and Image","sponsor_type":"Other","conditions":"Age-Related Macular Degeneration","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Phenotypic classification of AMD in the five-year clinical visit. Comparison of this classification with the grading of 5 years ago.","time_frame":"5 years"},{"outcome_type":"secondary","measure":"Risk factors: Demographic, Medical history, Ophthalmologic history, Family history of AMD, Systemic comorbidities and medication, Nutritional and Lifestyle habits. Signs of AMD on the multimodal evaluation.","time_frame":"5 years"}]}
{"nct_id":"NCT02788045","start_date":"2016-07-31","phase":"Phase 1/Phase 2","enrollment":201,"brief_title":"Safety, Tolerability and Immunogenicity Study of Different Vaccine Regimens of Trivalent Ad26.Mos.HIV or Tetravalent Ad26.Mos4.HIV Along With Clade C Glycoprotein (gp)140 in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Adults","official_title":"A Randomized, Parallel-Group, Placebo-Controlled, Double-Blind Phase 1/2a Study in Healthy HIV Uninfected Adults to Assess the Safety/Tolerability and Immunogenicity of 2 Different Prime/Boost Regimens; Priming With Trivalent Ad26.Mos.HIV and Boosting With Trivalent Ad26.Mos.HIV And Clade C Gp140 Plus Adjuvant or Priming With Tetravalent Ad26.Mos4.HIV and Boosting With Tetravalent Ad26.Mos4.HIV and Clade C Gp140 Plus Adjuvant","primary_completion_date":"2023-04-30","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2023-04-30","last_update":"2021-02-17","description":"The purpose of this study is to assess the safety/tolerability of the 2 different vaccine regimens of priming with trivalent Ad26.Mos.HIV and boosting with trivalent Ad26.Mos.HIV and Clade C gp140 plus adjuvant or priming with tetravalent Ad26.Mos4.HIV and boosting with Ad26.Mos4.HIV and Clade C glycoprotein (gp)140 plus adjuvant. Immune responses of the different vaccine schedules will be assessed.","other_id":"CR108152","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Are negative for human immunodeficiency virus (HIV) infection at screening\r\n\r\n          -  Is healthy on the basis of physical examination, medical history, electrocardiogram\r\n             (ECG), and vital signs measurement performed at screening\r\n\r\n          -  Are willing/able to adhere to the prohibitions and restrictions specified in the\r\n             protocol and study procedures\r\n\r\n          -  Female participants of childbearing potential must have a negative serum pregnancy\r\n             test (beta human chorionic gonadotropin [beta hCG]) at the Screening visit, and a\r\n             negative urine pregnancy test pre-dose on Day 1\r\n\r\n          -  Are assessed by the clinic staff as being at low risk for HIV infection\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Has chronic hepatitis B (measured by hepatitis B surface antigen test) or active\r\n             hepatitis C (measured by hepatitis C virus [HCV] Ab test; if positive, HCV ribonucleic\r\n             acid [RNA] PCR test will be used to confirm active versus past HCV infection), active\r\n             syphilis infection, chlamydia, gonorrhea, or trichomonas . Active syphilis documented\r\n             by serology unless positive serology is due to past treated infection\r\n\r\n          -  Has had a thyroidectomy or active thyroid disease requiring medication during the last\r\n             12 months (not excluded: a stable thyroid supplementation)\r\n\r\n          -  Has had major psychiatric illness and/or substance abuse problems during the past 12\r\n             months (including hospitalization or periods of work disability) that in the opinion\r\n             of the investigator would preclude participation\r\n\r\n          -  Has been in receipt of any licensed vaccine within 14 days prior to the first dose of\r\n             study vaccine/placebo, plans to receive within 14 days after the first study\r\n             vaccination, or plans to receive within 14 days before or after the second, third or\r\n             fourth vaccination\r\n\r\n          -  Is a recipient of a prophylactic or therapeutic HIV vaccine candidate at any time, or\r\n             a recipient of other experimental vaccine(s) within the last 12 months prior to the\r\n             Day 1 visit (Vaccination 1). For participants who received an experimental vaccine\r\n             (except HIV vaccine) more than 12 months prior to the Day 1 visit (Vaccination 1),\r\n             documentation of the identity of the experimental vaccine must be provided to the\r\n             sponsor, who will determine eligibility on a case-by-case basis\r\n      ","sponsor":"Janssen Vaccines & Prevention B.V.","sponsor_type":"Industry","conditions":"Healthy","interventions":[{"intervention_type":"Biological","name":"Biological: Ad26.Mos.HIV","description":"Recombinant replication-deficient Ad26 vectored vaccine and consists of 3 Ad26 vectors, one containing a mosaic insert of envelope (Env) sequence, and 2 vectors containing mosaic inserts of Gag and Pol sequences (Ad26.Mos.1.Env + Ad26.Mos1.Gag-Pol + Ad26.Mos2.Gag-Pol). Total dose is 5*10^10 viral particle per 0.5 milliliter (mL) injection administered intramuscularly."},{"intervention_type":"Biological","name":"Biological: Ad26.Mos4.HIV","description":"Recombinant replication-deficient Ad26 vectored vaccine and consists of 4 Ad26 vectors, 2 containing a mosaic insert of envelope (Env) sequence, and 2 vectors containing mosaic inserts of Gag and Pol sequences (Ad26.Mos.1.Env + Ad26.Mos.2S.Env + Ad26.Mos1.Gag-Pol + Ad26.Mos2.Gag-Pol). Total dose is 5*10^10 viral particle per 0.5mL injection administered intramuscularly."},{"intervention_type":"Biological","name":"Biological: Clade C gp140","description":"Clade C gp140 vaccine containing 250 mcg of total protein, mixed with aluminum phosphate adjuvant, per 0.5 mL injection administered intramuscularly."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Normal saline 0.9 percent (%), 0.5 mL injection administered intramuscularly."}],"outcomes":[{"outcome_type":"primary","measure":"Local And Systemic Solicited Adverse Events (Aes) for 7 Days Post-Vaccination","time_frame":"Baseline up to 7 days after each vaccination","description":"Participants will be asked to note occurrences of local reactions: pain/tenderness, erythema, swelling/induration at the injection site, and systemic events: fever (temperature measurement), fatigue, headache, nausea, myalgia and chills daily for 7 days post-vaccination."},{"outcome_type":"primary","measure":"AEs for 28 Days After Each Vaccination","time_frame":"Baseline up to 28 days after each vaccination"},{"outcome_type":"primary","measure":"Discontinuations From Vaccination/From Study Due to AEs","time_frame":"Baseline up to Week 72"},{"outcome_type":"primary","measure":"Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) During the Course of the Study, Including the Optional LTE Phase","time_frame":"Baseline up to Week 312"},{"outcome_type":"primary","measure":"Envelope (Env)-specific Binding Antibody (Abs) (Titers and Breadth)","time_frame":"Baseline up to Week 312"},{"outcome_type":"secondary","measure":"Env-specific Neutralizing Antibody (nAbs) (Titers and Breadth) (for Tier 1 and Tier 2 Viruses)","time_frame":"Baseline up to Week 312"},{"outcome_type":"secondary","measure":"Env-specific Functional Abs (Phagocytosis Score and Breadth)","time_frame":"Baseline up to Week 312"},{"outcome_type":"secondary","measure":"Env-specific Binding Ab Isotypes (Immunoglobulin A [Iga], Igg1-4) (Titers and Breadth)","time_frame":"Baseline up to Week 312"},{"outcome_type":"secondary","measure":"Interferon (IFN)-gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic Peptide Pools of Env/Group-specific Antigen (Gag)/Polymerase (Pol) and Potential T-cell Epitope (PTE)","time_frame":"Baseline up to Week 312"},{"outcome_type":"secondary","measure":"Cluster of Differentiation (Cd)4+ and Cd8+ T-Cell Functionality (Percentage [%] Cells Producing I-alpha, Ifn-gamma, Interleukin [Il-2], Il-4, Tumor Necrosis Factor [Tnf]-alpha)","time_frame":"Baseline up to Week 312"},{"outcome_type":"secondary","measure":"T-Cell Development With Emphasis on Follicular Helper T-Cells and Memory Differentiation","time_frame":"Baseline up to Week 72"},{"outcome_type":"secondary","measure":"Available Samples From Time Points After Last Vaccination Until the Final Main Study Visit at Week 72 Will be Used for Determination of Durability of the Immune Responses","time_frame":"Baseline up to Week 72"}]}
{"nct_id":"NCT02854709","start_date":"2016-07-31","phase":"N/A","enrollment":21,"brief_title":"Effects of Sleep Extension on Glucose Metabolism in Chronically Sleep Deprived Individuals","primary_completion_date":"2017-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-06-30","last_update":"2017-07-18","description":"This is a randomized cross over study of the effect of 2-week sleep extension in chronically sleep deprived non-diabetic individuals on glucose metabolism.","other_id":"065912","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  self-reported sleep duration =<6 hours/night during the week with a desire to sleep at\r\n             least 7 hours/night\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  shift workers,\r\n\r\n          -  diabetes history,\r\n\r\n          -  drugs affecting sleep or glucose metabolism,\r\n\r\n          -  insomnia symptoms,\r\n\r\n          -  high risk for sleep apnea,\r\n\r\n          -  smoking or excess alcohol use\r\n      ","sponsor":"Ramathibodi Hospital","sponsor_type":"Other","conditions":"Sleep Extension|Glucose Metabolism","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Sleep extension","description":"Sleep extension by 1 hour for 2 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Glucose metabolism","time_frame":"2 weeks","description":"Glucose and insulin values from 75 gram OGTT"}]}
{"nct_id":"NCT02870504","start_date":"2016-07-31","phase":"N/A","enrollment":60,"brief_title":"Clinical Study of LPI on Different Sites of Iris","official_title":"Clinical Study of Laser Peripheral Iridoplasty on Different Sites of Iris","primary_completion_date":"2017-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2017-12-31","last_update":"2016-09-13","description":"Glaucoma is the second cause of blindness worldwide. Laser peripheral iridoplasty (LPI) is a simple and effective treatment for angle closure glaucoma. LPI can widen or reopen an existing angle close or angle adhesion in order to reduce the risk of attack of the angle closure glaucoma. However, there are very little research on the laser site, laser wavelengths, laser energy and laser spot intervals. The purpose of this study is to determine the optimum laser site of LPI.","other_id":"[2016]102-1","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":30,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with primary angle closure suspect (PACS), primary angle closure (PAC) or\r\n             primary angle closure glaucoma (PACG).\r\n\r\n          -  PACS is diagnosed in eyes with an occludable angle but no other abnormality.\r\n\r\n          -  PAC is diagnosed in eyes with an occludable angle, normal optic discs and visual\r\n             fields and any of the following: raised IOP (>19 mm Hg), PAS, pigment smearing in the\r\n             superior angle, or sequelae of acute angle closure (iris whirling or glaucomatous\r\n             fleck).\r\n\r\n          -  PACG is diagnosed in eyes with an occludable angle and glaucomatous optic neuropathy.\r\n             Evidence of glaucomatous optic neuropathy is defined as a cup: disc ratio (CDR) of\r\n             >0.7 or >0.2 CDR asymmetry.\r\n\r\n          -  An occludable angle is defined as one in which three quarters of the posterior\r\n             pigmented trabecular meshwork is not visible on viewing with a Goldmann two mirror\r\n             lens in the primary position of gaze without indentation.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with previous ocular surgery, and those with secondary angle closure, such as\r\n             lens intumescence or subluxation, iris neovascularisation and a history of uveitis.\r\n\r\n          -  Patients who have systemic contraindications to medical therapy (including renal\r\n             impairment, sulfur allergy, asthma and heart failure), pre-existing corneal opacities\r\n             obstructing laser access to more than one quadrant of the peripheral iris and\r\n             single-eyed patients are also excluded.\r\n      ","sponsor":"First Affiliated Hospital of Fujian Medical University","sponsor_type":"Other","conditions":"Glaucoma","interventions":[{"intervention_type":"Procedure","name":"Procedure: Corneoscleral limbus group","description":"Laser spot locates on the corneoscleral limbus"},{"intervention_type":"Procedure","name":"Procedure: one spot group","description":"Laser spot locates on one spot away from the corneoscleral limbus"},{"intervention_type":"Procedure","name":"Procedure: two spots group","description":"Laser spot locates on two spots away from the corneoscleral limbus"}],"outcomes":[{"outcome_type":"primary","measure":"Change of anterior chamber angle(AA)","time_frame":"Baseline and 3 months after LPI","description":"Anterior chamber angle (AA) is measured with ultrasound biomicroscopy."},{"outcome_type":"secondary","measure":"Change of anterior chamber angle opening distance 750(AOD750)","time_frame":"Baseline and 3 months after LPI","description":"Anterior chamber angle opening distance 750(AOD750) is measured with ultrasound biomicroscopy."},{"outcome_type":"secondary","measure":"Change of anterior chamber depth(ACD)","time_frame":"Baseline and 3 months after LPI.","description":"Anterior chamber depth(ACD) is measured with ultrasound biomicroscopy."},{"outcome_type":"secondary","measure":"Change of intraocular pressure (IOP)","time_frame":"Baseline and 1hour, 1days, 3day, 7days, 1 month, 3 months after LPI.","description":"IOP is measured with Goldmann tonometry."},{"outcome_type":"secondary","measure":"Change of C value","time_frame":"Baseline and 7days, 1 month, 3 months after LPI.","description":"IOP is measured with Schφtz tonometry."},{"outcome_type":"secondary","measure":"Change of retinal nerve layer thickness","time_frame":"Baseline and 3 months after LPI.","description":"Retinal nerve layer thickness is measured with optical coherence tomography."},{"outcome_type":"secondary","measure":"Change of optic disc cup disc ratio","time_frame":"Baseline and 3 months after LPI.","description":"Optic disc cup disc ratio is measured with optical coherence tomography."},{"outcome_type":"secondary","measure":"Change of mean defect","time_frame":"Baseline and 3 months after LPI.","description":"Mean defect is measured with computer perimetry."},{"outcome_type":"secondary","measure":"Change of mean sensitivity","time_frame":"Baseline and 3 months after LPI.","description":"Mean sensitivity is measured with computer perimetry."},{"outcome_type":"secondary","measure":"Change of scotoma","time_frame":"Baseline and 3 months after LPI.","description":"Scotoma is measured with computer perimetry."}]}
{"nct_id":"NCT02828241","start_date":"2016-07-31","phase":"Phase 2","enrollment":61,"brief_title":"A Study to Assess the Efficacy, Safety and Tolerability of DFD-04","official_title":"A Multi-center, Randomized, Double-Blind, Parallel-group, Placebo-Controlled Study to Assess the Efficacy, Safety and Tolerability of DFD-04 (Itraconazole) Ointment, 5% in Patients With Inflammatory Lesions of Rosacea Over 12 Weeks","primary_completion_date":"2017-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-11-30","last_update":"2019-01-23","description":"The purpose of this exploratory study is to assess the efficacy, safety and tolerability of DFD-04 Ointment for topical treatment of rosacea over 12 weeks of treatment.","other_id":"DFD04-CD-002","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":64,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Subjects must be able to understand the requirements of the study and be willing to\r\n             give written informed consent.\r\n\r\n          2. Subjects must be willing to provide authorization to use protected health information.\r\n\r\n          3. Subjects, any gender or race, must be in good general health as determined by the\r\n             Investigator\r\n\r\n          4. Subjects must have a clinical diagnosis of papulopustular rosacea, Investigator's\r\n             Global Assessment (IGA) grade 2 - 3.\r\n\r\n          5. Subjects must have 6 - 30 inflammatory lesions (papules and pustules) of rosacea over\r\n             the face.\r\n\r\n          6. Subjects must have a Clinician's Erythema Assessment (CEA) score of 2 - 3.\r\n\r\n          7. Subjects must have no more than 2 nodules.\r\n\r\n          8. Subjects must agree to only use the study products and to not use any other treatment\r\n             for rosacea (prescription or over the counter) or any other skin care or cosmetics\r\n             product (make-up etc.) on the facial skin of the treatment area during the course of\r\n             the study.\r\n\r\n          9. Subjects must be free of any systemic or dermatologic disorder, which in the opinion\r\n             of the Investigator, will interfere with the study results.\r\n\r\n         10. Females have a negative urine pregnancy test at the Screening and Baseline Visit.\r\n\r\n         11. Females must either be postmenopausal with no menses for at least 12 months or\r\n             surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method\r\n             of contraception with a failure rate of less than 1 percent per year when used\r\n             consistently and correctly.\r\n\r\n         12. Subject must be in good general health as determined by the investigator and supported\r\n             by the medical history and normal or not clinically significant abnormal vital signs\r\n             (blood pressure and pulse).\r\n\r\n         13. Subject is physically able to apply study product to all affected areas.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Females who are pregnant or nursing or planning to become pregnant during the study.\r\n\r\n          2. Subjects who have been treated for rosacea within the 30 days prior to the Baseline\r\n             Visit.\r\n\r\n          3. Subjects who have been treated with systemic retinoids within 6 months prior to the\r\n             Baseline visit.\r\n\r\n          4. Subjects who have participated in a trial involving any investigational product in the\r\n             30 days prior to the Baseline Visit.\r\n\r\n          5. Subjects with any disease or medical condition that would interfere with the study or\r\n             place the subject at undue risk especially cardiovascular diseases, reduced lung\r\n             function (including asthma), renal dysfunction or liver dysfunction.\r\n\r\n          6. Subjects who have been treated within 30 days prior to baseline visit with\r\n             methadone,disopyramide, dofetilide, dronedarone, quinidine, ergot alkaloids (such as\r\n             dihydroergotamine, ergometrine (ergonovine), ergotamine, methylergometrine\r\n             (methylergonovine)), irinotecan, lurasidone, oral midazolam, pimozide, triazolam,\r\n             felodipine, nisoldipine, ranolazine, eplerenone, cisapride, lovastatin, simvastatin,\r\n             ticagrelor, terfenadine, astemizole, mizolastine, eletriptan, as well as lovastatin,\r\n             simvastatin and atorvastatin and, in subjects with varying degrees of renal or hepatic\r\n             impairment, colchicine, fesoterodine, telithromycin and solifenacin.\r\n\r\n          7. Subjects who use or have used systemic steroids within the 30 days prior to the\r\n             Baseline Visit or any other immunosuppressive medication.\r\n\r\n          8. Subjects positive for human immunodeficiency virus (HIV), hepatitis B and hepatitis\r\n             C-test at screening.\r\n\r\n          9. Subjects who are unable to comply with study requirements.\r\n\r\n         10. Subjects with other skin diseases that may confound the evaluation of rosacea.\r\n\r\n         11. History of organ transplant requiring immunosuppression, HIV, or other immune\r\n             compromised state.\r\n\r\n         12. Subject who in the opinion of the investigator or physician performing the initial\r\n             examination the subject should not participate in the trial, e.g. due to probable\r\n             noncompliance or inability to understand the trial and give adequately informed\r\n             consent\r\n\r\n         13. Subject with close affiliation with the investigator (e.g. a close relative) or\r\n             persons working at the respective trial sites or subject who are an employee of\r\n             sponsor.\r\n\r\n         14. Subject institutionalized because of legal or regulatory order.\r\n\r\n         15. History of drug or alcohol abuse in the last year.\r\n      ","sponsor":"Dr. Reddy's Laboratories Limited","sponsor_type":"Industry","conditions":"Rosacea","interventions":[{"intervention_type":"Drug","name":"Drug: DFD-04 Ointment"},{"intervention_type":"Other","name":"Other: Placebo Ointment"}],"outcomes":[{"outcome_type":"primary","measure":"Change in Inflammatory Lesion Counts","time_frame":"At the end of study (12 weeks)","description":"Mean change from Baseline in the inflammatory lesion count at the End of Treatment. A lower score at the end of the study compared to Baseline is considered a better outcome."},{"outcome_type":"primary","measure":"Number of Subjects With Investigator's Global Assessment (IGA) Success","time_frame":"At the end of study (12 weeks)","description":"Number of subjects with treatment success based on Investigator's Global Assessment (IGA) score at the End of Treatment, defined as an IGA score of 0 (clear) or 1 (almost clear) with composite grade change from Baseline of at least 2 points."},{"outcome_type":"primary","measure":"Number of Subjects With Treatment Success by Clinician's Erythema Assessment (CEA) Scale","time_frame":"At end of study (12 weeks)","description":"Number of subjects with Treatment Success defined as a score of 0 or 1 and a 2 grade improvement on the CEA scale from Baseline to 12 weeks."}]}
{"nct_id":"NCT02978872","start_date":"2016-07-31","enrollment":30,"brief_title":"Quantra Determination of Coagulation Parameters in Arterial and Venous Blood","official_title":"Comparison of Coagulation Parameters in Arterial and Venous Blood Measured Using the Quantra System","primary_completion_date":"2017-01-31","study_type":"Observational","rec_status":"Completed","completion_date":"2017-01-31","last_update":"2017-04-19","description":"The Quantra System is a novel point-of-care diagnostic device designed to perform whole blood coagulation analysis. This study compares Quantra measurements determined in arterial versus venous blood samples obtained from patients undergoing cardiac surgery.","other_id":"HEMCS-005","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Adult patients scheduled for cardiac surgery, utilizing cardiopulmonary bypass, or\r\n        including placement of a ventricular assist device.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subject is scheduled for cardiac surgery, utilizing cardiopulmonary bypass, or\r\n             including placement of a ventricular assist device\r\n\r\n          -  Subject is 18 years\r\n\r\n          -  Subject is willing to participate and he/she has signed a consent form\r\n\r\n          -  Subject may participate if they have a history of bleeding or are on preoperative\r\n             anticoagulant therapy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subject is unable to provide written informed consent\r\n\r\n          -  Subject is younger than 18 years\r\n\r\n          -  Subject is incarcerated at the time of the study\r\n\r\n          -  Subject is currently enrolled in a study that may confound the results of the proposed\r\n             study\r\n\r\n          -  Subject is affected by a condition that, in the opinion of the surgical team, may pose\r\n             additional risks\r\n      ","sponsor":"HemoSonics LLC","sponsor_type":"Industry","conditions":"Cardiac Surgery","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Comparison of Clot Time and Clot Stiffness results between arterial and venous samples","time_frame":"Up to 24 hours","description":"Coagulation function assessed by Quantra at 2 time points (Baseline and either during cardiac bypass or post-bypass)"},{"outcome_type":"secondary","measure":"Comparison of Quantra results to standard coagulation test results in venous samples","time_frame":"Up to 24 hours","description":"Coagulation function assessed by Quantra and standard coagulation tests at 2 time points (Baseline and either during cardiac bypass or post-bypass)"},{"outcome_type":"secondary","measure":"Comparison of Quantra results to comparable ROTEM results in venous samples","time_frame":"Up to 24 hours","description":"Coagulation function assessed by Quantra and ROTEM at 2 time points (Baseline and either during cardiac bypass or post-bypass)"}]}
{"nct_id":"NCT03033095","start_date":"2016-07-31","phase":"N/A","enrollment":50,"brief_title":"Prediction of the Answer to the Treatment by Biotherapies for Naive Spondyloarthritis by Combinatorial Analysis of Serum Biomarkers","official_title":"Prediction of the Answer to the Treatment by Biotherapies for Naive Spondyloarthritis Disease During 6 Months by Combinatorial Analysis of Serum Biomarkers","primary_completion_date":"2017-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-01-31","last_update":"2018-06-06","description":"The aim of this trial is the caracterisation of a predicting algorithm of the answering response for patients with etanercept treatment in spondyloarthritis disease. This algorithm will help to target patients patients who have a risk / benefit important for etanercept treatment.","other_id":"38RC16.018","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Screening","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  patients with spondylarthritis validating ASAS or New York modified critera, and for\r\n             who etanercept is indicated.\r\n\r\n          -  Nave from biological Drug Modifying Anti Rheumatic Drugs\r\n\r\n          -  patients between 18 and 70 years old\r\n\r\n          -  patients who can be monitored at 6 months ;\r\n\r\n          -  patients who can observe the entire treatment ;\r\n\r\n          -  patiens with age to procreate under effective contraception ((abstinence, oral\r\n             contraceptives , intrauterine devices , implants, spermicide or surgical sterilization\r\n             ) during the study and for 6 months, 3 weeks after the last injection.\r\n\r\n          -  patients able to understand and accept the terms of the study\r\n\r\n          -  patients having signed the informed consent.\r\n\r\n          -  patients insured under social security\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  patients of age protected ;\r\n\r\n          -  patients with difficulties for understanding french language ;\r\n\r\n          -  patients with high function disorders incompatible with an education program (dementia\r\n             Alzheimer's type , etc ...) ;\r\n\r\n          -  patients with psycho- social instability incompatible with regular monitoring\r\n             (homeless , addictive behavior ,etc.) ;\r\n\r\n          -  patients in a socio- professional situation incompatible with optimal attendance to\r\n             the program - - Pregnant or nursing patients\r\n\r\n          -  patients who received previously a biotherapy treatment . There is no other exclusion\r\n             criteria taking into account previous treatments and the duration of them.\r\n\r\n          -  contraindication to the use of anti- TNF treatment\r\n\r\n          -  Surgery scheduled during the study.\r\n\r\n          -  Persons mentioned in Articles L.1121-5 to L.1121-8 of the Public Health Code\r\n      ","sponsor":"University Hospital, Grenoble","sponsor_type":"Other","conditions":"Spondylitis, Ankylosing","interventions":[{"intervention_type":"Drug","name":"Drug: Etanercept  50 mg","description":"The etanercept is not the experimental study drug. Etanercept is a treatment justifying the inclusion of patients and is used in accordance with its marketing authorization."}],"outcomes":[{"outcome_type":"primary","measure":"Measurement of disease activity with AS- DAS score (Ankylosing Spondylitis - Disease Activity Score )","time_frame":"6 months after inclusion","description":"An important clinical ASAS response, corresponds to a variation of the ASDAS CRP ≥ 1.1"},{"outcome_type":"secondary","measure":"Measurement of BASDAI response","time_frame":"6 months after inclusion","description":"Sensitivity and specificity of the algorithm for BASDAI response : BASDAI response 50, that means an improvement of BASDAI response of 50% or more"},{"outcome_type":"secondary","measure":"biomarkers analysis for personalized medicine","time_frame":"at the inclusion and 6 months after","description":"8 biomarkers will be analysed :\r\ncalcium-binding protein complex S100A8/A9,\r\nprealbumin,\r\nhaptoglobin (Hapto),\r\nprotéine C-réactive (CRP),\r\nα1 anti-trypsin\r\napolipoprotéinA1 (ApoA1),\r\nplatelet factor 4 (PF4),\r\nS100A12 protein,"}]}
{"nct_id":"NCT02818868","start_date":"2016-07-31","enrollment":700,"brief_title":"Impact of Apixaban on Clinical Outcome of the Patients With Large Vessel Occlusion or Stenosis Trial","official_title":"Impact of Apixaban on Clinical Outcome of the Patients With Large Vessel Occlusion or Stenosis Trial","primary_completion_date":"2018-02-28","study_type":"Observational","rec_status":"Completed","completion_date":"2018-02-28","last_update":"2019-08-06","description":"The aim of this study is to investigate the clinical events of the patients with acute cerebral large vessel occlusion or stenosis and atrial fibrillation, treated by apixaban within 14 days after onset. This is the observational study that patients will be made the registration at the timing of both retrospective period and prospective period.","other_id":"2157","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":20,"population":"Any adult patient with acute stroke who treated with apixaban.","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patients 20 years and older with acute stroke and treated with oral apixaban within 14\r\n             days after onset.\r\n\r\n          2. Patients who are hospitalized in a period from Oct 1, 2014 to Feb 28, 2018\r\n\r\n          3. Patients with acute cerebral large vessel occlusion or stenosis (> 50%)\r\n\r\n          4. Patients with non-valvular atrial fibrillation\r\n\r\n          5. Patients who are not confirmed ICH by MRI or CT within 24 hours after r-tPA infusion.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients who are considered to be ineligible for the study participation by the\r\n             investigator.\r\n\r\n          2. Patients who are pregnant or potentially pregnant.\r\n\r\n          3. Patients who have a history of hypersensitivity to apixaban\r\n\r\n          4. Patients with hepatic disease having coagulation disorder and clinically important\r\n             bleeding risk\r\n\r\n          5. Patients with renal failure (creatinine clearance < 15 mL/min) 6Patients with Active\r\n             pathological bleeding including intracranial bleeding of any type\r\n      ","sponsor":"Hyogo College of Medicine","sponsor_type":"Other","conditions":"Ischemic Stroke","interventions":[{"intervention_type":"Drug","name":"Drug: apixisaban"}],"outcomes":[{"outcome_type":"secondary","measure":"modified Rankin Scale","time_frame":"90 days (±10 days) and 365days（±10 days） after disease onset"},{"outcome_type":"secondary","measure":"Death","time_frame":"30 days and 365day"},{"outcome_type":"secondary","measure":"Ischemic event","time_frame":"30 days and 365day"},{"outcome_type":"secondary","measure":"Bleeding event","time_frame":"30 days and 365day"},{"outcome_type":"primary","measure":"Death","time_frame":"90 days after disease onset"},{"outcome_type":"primary","measure":"Ischemic events","time_frame":"90 days after disease onset"},{"outcome_type":"primary","measure":"Bleeding events","time_frame":"90 days after disease onset"},{"outcome_type":"secondary","measure":"Significant bleeding (ISTH)","time_frame":"30 days 90 days (±10 days) and 365day","description":"scale bleeding events Among the major bleeding , according to the society and hemostasis of international thrombosis (ISTH) bleeding criteria , those that fall under any of the following criteria .\r\nlethal bleeding\r\nimportant sites or symptomatic bleeding of organs ( intracranial, bone marrow , in the eye , retroperitoneal , intra-articular , or heart sac bleeding , or muscle hemorrhage with a compartment syndrome )\r\nhemoglobin value has decreased 2 g / dL or more bleeding , whole blood transfusion or red blood cells ( more than 2 units) bleeding that required blood transfusion"},{"outcome_type":"secondary","measure":"Symptomatic intracranial hemorrhage (sICH)","time_frame":"0 days, 90 days and 365days","description":"scale\r\nSymptomatic intracranial hemorrhage (SICH): new intracranial hemorrhage , which corresponds to one of the following:\r\n1) which compared to the worse just before the NIHSS, admitted the deterioration of more than 4 points 2 ) that recognized the deterioration of two or more points in one of the NIHSS category 3 ) intubation / outside decompression / drainage detention or other things that led to the expensive medical / surgical intervention 4 ) it is not a worsening due to other causes"},{"outcome_type":"secondary","measure":"Ischemic stroke and systemic embolism","time_frame":"30 days, 90 days and 365days","description":"systemic embolism defined as an event in which the cases with embolism of extremity arteries, intestinal arteries, renal arteries, etc., accompanied by symptoms of local organs."}]}
{"nct_id":"NCT02846987","start_date":"2016-07-31","phase":"Phase 2","enrollment":33,"brief_title":"Study of Abemaciclib in Dedifferentiated Liposarcoma","official_title":"Phase 2 Study of Abemaciclib (LY2835219) in Dedifferentiated Liposarcoma","primary_completion_date":"2023-07-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2023-07-31","last_update":"2021-08-18","description":"The purpose of this study is to test any good and bad effects of the study drug called Abemaciclib. Abemaciclib could shrink your cancer but it could also cause side effects. Researchers hope to learn if the study drug will delay the growth of the cancer or shrink the cancer by at least one quarter compared to its present size. Abemaciclib is not FDA approved and has not been tested in liposarcoma, but it has shrunk tumors in patients with breast cancer, lymphoma, and lung cancer.","other_id":"16-376","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  A diagnosis of dedifferentiated liposarcoma confirmed at MSKCC.\r\n\r\n          -  Metastatic and/or locally advanced or locally recurrent disease that is not surgically\r\n             resectable.\r\n\r\n          -  All patients must have measurable disease as defined by RECIST 1.1. Patients must also\r\n             have evidence of disease progression by RECIST 1.1 within 6 months of first dose of\r\n             study drug.\r\n\r\n          -  Any number of prior therapies (including none) is permitted. The last dose of systemic\r\n             therapy (include targeted therapies) must have been given at least 2 4 weeks prior to\r\n             initiation of therapy. Patients receiving BCNU or mitomycin C must have received their\r\n             last dose of such therapy at least 6 weeks prior to initiation of therapy.\r\n\r\n          -  Patients with brain metastasis that have been treated with definitive surgery or\r\n             radiation and have been clinically stable for 3 months are eligible.\r\n\r\n          -  Age  18 years.\r\n\r\n          -  ECOG performance status 0 or 1\r\n\r\n          -  Adequate organ and marrow function as defined below (ULN indicates institutional upper\r\n             limit of normal):\r\n\r\n          -  Absolute neutrophil count  1.510^9/L\r\n\r\n          -  Hemoglobin  8.0 g/dL\r\n\r\n          -  WBC  3.0 x 10^9/L\r\n\r\n          -  Platelets  100 x 10^9/L\r\n\r\n          -  Total bilirubin  1.5 x ULN except for patients with known Gilbert syndrome\r\n\r\n          -  AST(SGOT)/ALT(SGPT)  3 x institutional ULN\r\n\r\n          -  Creatinine  1.5 x ULN or Creatinine Clearance > 50 mL/min (calculated by\r\n             Cockcroft-Gault method)\r\n\r\n          -  Patients must not have current evidence of another malignancy that requires treatment.\r\n\r\n          -  Women of child-bearing potential and men must agree to use adequate contraception\r\n             (hormonal or barrier method of birth control; abstinence). Women must not breast feed\r\n             while on study.\r\n\r\n          -  Ability to understand and the willingness to sign a written informed consent document.\r\n\r\n          -  Ability to swallow capsules\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who have not recovered from adverse events of prior therapy to  NCI\r\n             CTCAEv4.0 Grade 1.\r\n\r\n          -  Patients receiving any other investigational agents.\r\n\r\n          -  Patients who have received prior treatment with a selective CDK4 inhibitor\r\n\r\n          -  Uncontrolled intercurrent illness including, but not limited to, known ongoing or\r\n             active infection, including HIV, active hepatitis B or C, symptomatic congestive heart\r\n             failure, unstable angina pectoris, cardiac arrhythmia (specifically, atrial\r\n             fibrillation or ventricular dysrhythmias except ventricular premature contractions),\r\n             or psychiatric illness/social situations that would limit compliance with study\r\n             requirements.\r\n\r\n          -  Pregnant women and women who are breast-feeding.\r\n      ","sponsor":"Memorial Sloan Kettering Cancer Center","sponsor_type":"Other","conditions":"Sarcoma|Dedifferentiated Liposarcoma","interventions":[{"intervention_type":"Drug","name":"Drug: Abemaciclib"}],"outcomes":[{"outcome_type":"primary","measure":"progression-free","time_frame":"12 weeks","description":"Progression includes both disease progression (as defined by RECIST 1.1) and death from any cause."}]}
{"nct_id":"NCT03081897","start_date":"2016-07-31","phase":"N/A","enrollment":40,"brief_title":"Regional Anaesthesia and Substance P in Head and Neck Cancer","official_title":"Influence of Regional Anaesthesia on the Expression of Substance P During Unilateral Neck Dissection Due to Head and Neck Cancer","primary_completion_date":"2018-07-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-07-31","last_update":"2017-06-06","description":"In the clinical trial the investigators will observe the impact of regional anesthesia in addition to a general anesthesia on the expression of substance P in patients with unilateral Head or Neck cancer undergoing unilateral Neck Dissection. The investigators will perform an unilateral regional cervical plexus block on the tumor side. The tissue of the tumor side will be analysed by immunohistology, measuring the expression of the Substance P.","other_id":"EA1/119/16","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients at Charit - Universitaetsmedizin Berlin, Campus Charit Mitte\r\n\r\n          -  Primary diagnosis of unilateral head or neck cancer\r\n\r\n          -  Resection of Tumor is planned with unilateral neck dissection\r\n\r\n          -  Patient did not underwent any therapeutic treatment of the cancer before start of\r\n             study\r\n\r\n          -  Surgical therapy is planned with curative intent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Allergy to local anesthetics\r\n\r\n          -  Coagulation disorders, which can lead to complications in regional anesthesia\r\n\r\n          -  Insulin-dependent diabetes mellitus, polyneuropathy\r\n\r\n          -  Severe psychiatric disorders\r\n\r\n          -  Dementia\r\n\r\n          -  Alcohol abuse, Korsakoff syndrome\r\n\r\n          -  Medication with immunosuppressants or immune modulantia\r\n\r\n          -  Patient under Special Care\r\n\r\n          -  Refusal of study participation\r\n\r\n          -  Pregnancy and breast feeding period.\r\n\r\n          -  Participation in a clinical intervention study, parallel with the study or\r\n             participation up to 30 days before inclusion\r\n\r\n          -  Lack of consent that pseudonomized data of the study may be saved and distributed\r\n      ","sponsor":"Charite University, Berlin, Germany","sponsor_type":"Other","conditions":"Head and Neck Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: SPRANC Block group","description":"General anaesthesia with Propofol (2mg/kgKG) and Remifentanil (0,1-0,4 g/kg/min); additional regional anaesthesia (cervical plexus block) with an long acting local anesthetic according to clinical estimation of the treating anesthetist (about 15 ml Ropivacaine 0,75% around the carotid bifurcation, 5 ml Ropivacaine in the region of Erbs Point of the superficial cervical plexus and 10 ml Ropivacaine at the area of skin incision on the tumor side); unilateral neck dissection."},{"intervention_type":"Drug","name":"Drug: SPRANC Control group","description":"General anaesthesia with Propofol (2mg/kgKG) and Remifentanil (0,1-0,4 g/kg/min); additional regional Patient Control Group (no Intervention planned), general anaesthesia with Propofol (2mg/kgKG) and Remifentanil (0,1-0,4 g/kg/min); unilateral neck dissection."}],"outcomes":[{"outcome_type":"primary","measure":"Expression of Substance P","time_frame":"2 years"}]}
{"nct_id":"NCT02754882","start_date":"2016-07-05","phase":"Phase 3","enrollment":763,"brief_title":"A Study Comparing SB8 and Avastin in Patients With Advanced Non-squamous Non-small Cell Lung Cancer","official_title":"A Phase 3, Randomised, Double-blind Study to Compare the Efficacy, Safety, PK and Immunogenicity Between SB8 (Proposed Bevacizumab Biosimilar) and Avastin in Subjects With Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer","primary_completion_date":"2018-01-24","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-10-09","last_update":"2019-01-03","description":"This study is designed to establish biosimilarity of SB8, a proposed biosimilar product of bevacizumab, to EU-sourced bevacizumab, in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC).","other_id":"SB8-G31-NSCLC","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Aged  18 years\r\n\r\n          2. ECOG performance status of 0-1\r\n\r\n          3. Histologically-confirmed metastatic or recurrent non-squamous non-small cell lung\r\n             cancer\r\n\r\n          4. At least one measurable lesion according to RECIST v1.1.\r\n\r\n          5. Able to receive bevacizumab, carboplatin and paclitaxel based on adequate laboratory\r\n             and clinical parameters\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Diagnosis of small cell carcinoma of the lung or squamous cell carcinoma\r\n\r\n          2. Sensitizing EGFR mutations or ALK rearrangements\r\n\r\n          3. Increased risk of bleeding determined by investigator based on radiographic / clinical\r\n             findings\r\n\r\n          4. History of systemic chemotherapy administered in the first-line setting for metastatic\r\n             or recurrent disease of NSCLC.\r\n      ","sponsor":"Samsung Bioepis Co., Ltd.","sponsor_type":"Industry","conditions":"Lung Cancer|Non-small Cell Lung Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Bevacizumab","description":"Avastin 15 mg/kg IV every 3 weeks on Day 1"},{"intervention_type":"Drug","name":"Drug: SB8","description":"SB8 15 mg/kg IV every 3 weeks on Day 1"},{"intervention_type":"Drug","name":"Drug: Carboplatin","description":"Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles"},{"intervention_type":"Drug","name":"Drug: Paclitaxel","description":"Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles"}],"outcomes":[{"outcome_type":"secondary","measure":"Incidence of Treatment-related Adverse Events using CTCAE v4.03","time_frame":"AEs will be reported from the time the informed consent form (ICF) is signed until the EOT visit. The expected EOT visit for a final subject is approximately 30 months from study initiation.","description":"After the end of treatment (EOT) visit, SAEs should be reported to the Sponsor if the Investigator becomes aware of them."},{"outcome_type":"secondary","measure":"Pharmacokinetics: Trough Level [Ctrough]","time_frame":"Up to 21 weeks (Cycle 1,3,5 and 7. Each cycle is 21 days.)","description":"Ctrough at selected cycles"},{"outcome_type":"secondary","measure":"Pharmacokinetics: Maximum Plasma Concentration [Cmax]","time_frame":"Up to 21 weeks (Cycle 1,3,5 and 7. Each cycle is 21 days.)","description":"Cmax at selected cycles"},{"outcome_type":"primary","measure":"Best Objective Response Rate by 24 weeks","time_frame":"24 weeks from randomisation","description":"Any PR or CR prior to the 24th week will be marked as response"},{"outcome_type":"secondary","measure":"Progression Free Survival","time_frame":"from the date of randomisation to the date of disease progression or death up to 12 months from randomisation of the last subject","description":"PFS from the date of randomisation to the date of disease progression or death up to 12 months from randomisation of the last subject"},{"outcome_type":"secondary","measure":"Overall Survival","time_frame":"from the date of randomisation to the date of death up to 12 months from randomisation of the last subject","description":"OS from the date of randomisation to the date of death up to 12 months from randomisation of the last subject"},{"outcome_type":"secondary","measure":"Duration of Response","time_frame":"from documented tumour response until disease progression up to 12 months from randomisation of the last subject","description":"DoR in subjects with response from documented tumour response until disease progression up to 12 months from randomisation of the last subject"},{"outcome_type":"secondary","measure":"Immunogenicity Assessments (Anti-drug Antibodies)","time_frame":"Up to 21 weeks (Cycle 1,3,5, 7 and EOT visit. Each cycle is 21 days. The expected EOT visit for a final subject is approximately 30 months from study initiation.)","description":"Incidence of anti-drug (bevacizumab) antibodies (ADA)"},{"outcome_type":"secondary","measure":"Immunogenicity Assessments (Neutralizing Antibodies)","time_frame":"Up to 21 weeks (Cycle 1,3,5, 7 and EOT visit. Each cycle is 21 days. The expected EOT visit for a final subject is approximately 30 months from study initiation.)","description":"Incidence of anti-drug (bevacizumab) antibodies (ADA) - neutralizing antibodies (NAb)"},{"outcome_type":"other","measure":"Best Objective Response Rate by 11 and 17 weeks","time_frame":"11 weeks and 17 weeks from randomisation","description":"Best ORR by 11 weeks and 17 weeks"}]}
{"nct_id":"NCT02843607","start_date":"2016-07-01","phase":"Phase 1/Phase 2","enrollment":30,"brief_title":"Combination of Cryosurgery and NK Immunotherapy for Advanced Kidney Cancer","primary_completion_date":"2017-07-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-07-01","last_update":"2019-09-12","description":"The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to advanced kidney cancer.","other_id":"NK-kidney","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":30,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  All standard therapies have failed according to NCCN guidelines or the patient refuses\r\n             standard therapies after cancer recurrence\r\n\r\n          -  Body tumor 1-6, the maximum tumor length < 5 cm\r\n\r\n          -  KPS  70, lifespan > 6 months\r\n\r\n          -  Platelet count  80109/Lwhite blood cell count  3109/L, neutrophil count \r\n             2109/L, hemoglobin  80 g/L\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with cardiac pacemaker\r\n\r\n          -  Patients with brain metastasis\r\n\r\n          -  Patients with grade 3 hypertension or diabetic complication, severe cardiac and\r\n             pulmonary dysfunction\r\n      ","sponsor":"Fuda Cancer Hospital, Guangzhou","sponsor_type":"Other","conditions":"Metastatic Renal Cell Cancer","interventions":[{"intervention_type":"Device","name":"Device: Cryosurgery","description":"Argon-helium cryosurgical system (percutaneous ablation under CT or ultrasound guidance)"},{"intervention_type":"Biological","name":"Biological: NK immunotherapy","description":"Natural killer cell (each treatment: about 10 billion cells transfusion in 3 times, i.v.)"}],"outcomes":[{"outcome_type":"primary","measure":"Relief degree","time_frame":"3 months","description":"It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）"},{"outcome_type":"secondary","measure":"Progress free survival（PFS）","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Overall survival（OS）","time_frame":"3 years"}]}
{"nct_id":"NCT02733354","start_date":"2016-06-30","enrollment":220,"brief_title":"Lifestyle Scenario Demonstration on Dialysis Modality","official_title":"Impact of Lifestyle Scenario Demonstration on Patients'Decision-making of Dialysis Modality","primary_completion_date":"2019-06-30","study_type":"Observational","rec_status":"Unknown status","last_update":"2016-04-12","description":"Based on real cases, daily life scenarios of peritoneal dialysis and hemodialysis patients were shooted and edited into video films, including environment of home dialysis, dietary patterns, water intake, sports mode, daily work, short time of travel and other activities, covering a certain natural day of either peritoneal or hemodialysis and some important time points in the way of life, such as nursing and treatment for common complications of the corresponding dialysis mode. The videos will also show the advantages and disadvantages of the two modes of dialysis. According to their actual living conditions, patients will decide the right dialysis modality that suite them well, thus improving dialysis compliance and psychological adaptability.","other_id":"2ndHarbinMU","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":70,"population":"CKD 5 patients,prepare for dialysis, aged between 18 to 70 years old, male or female,","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  CKDchronic kidney disease stage 5 patients with replacement therapy indications,\r\n             age 18 years, 70 years\r\n\r\n          -  without any contraindications of peritoneal dialysis or hemodialysis\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Age> 70 years or <18 years old\r\n\r\n          -  contraindications of peritoneal dialysis or hemodialysis\r\n\r\n          -  Patients who cannot be followed well after dialysis.\r\n      ","sponsor":"The Second Affiliated Hospital of Harbin Medical University","sponsor_type":"Other","conditions":"Dialysis Mode Life Scenarios","interventions":[{"intervention_type":"Device","name":"Device: watch viedo"}],"outcomes":[{"outcome_type":"primary","measure":"Conversion rates","time_frame":"two years"},{"outcome_type":"secondary","measure":"Informed Decision Score","time_frame":"two years"}]}
{"nct_id":"NCT02889432","start_date":"2016-06-30","phase":"Phase 2","enrollment":40,"brief_title":"Effects of Oral Melatonin on Neurosensory Recovery Following Facial Osteotomies","official_title":"Effects of Oral Melatonin on Neurosensory Recovery Following Facial Osteotomies - A Randomised, Controlled Clinical Trial","primary_completion_date":"2017-08-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2017-09-30","last_update":"2016-09-07","description":"Orthognathic surgery is commonly performed for the treatment of dentofacial deformities. Yet, one of the most prevalent and long-term complication encountered is neurosensory disturbance thus impairing sensation to parts of the face. In Hong Kong, it has been reported that in patients receiving orthognathic surgery, 5.9% experience long-term neurosensory disturbance post-surgery. Melatonin is a neurohormone that is produced and secreted by the pineal gland in the brain. Its main physiological role in humans is to regulate sleep. Oral Melatonin supplements is also used in the management of jetlag and other sleep disorders. Recently, animal and human studies have shown Melatonin to improve tolerance to pain and to have a neuroprotective and neuroregenerative effect after nerve injuries. Hence, it is hypothesized that peri-surgical oral Melatonin supplement can improve neurosensory recovery after orthognathic surgery","other_id":"UW 16-095","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  No systemic neuropathies\r\n\r\n          -  Clear medical history\r\n\r\n          -  Patients requiring bilateral sagittal split osteotomies, Hofer osteotomy, genioplasty,\r\n             and/or Le-Fort I osteotomies\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with existing neurosensory deficit at the inferior alveolar nerve and/or\r\n             infraorbital nerve from previous trauma or systemic condition\r\n\r\n          -  Patients with iatrogenic severance of nerve intra-operatively\r\n\r\n          -  Patients who underwent previous orthognathic surgery (i.e. reoperation)\r\n\r\n          -  Patients undergoing distraction osteogenesis\r\n\r\n          -  Patients who developed allergic reactions\r\n      ","sponsor":"The University of Hong Kong","sponsor_type":"Other","conditions":"Dentofacial Deformities","interventions":[{"intervention_type":"Drug","name":"Drug: Oral Melatonin 10mg"},{"intervention_type":"Drug","name":"Drug: Placebo"}],"outcomes":[{"outcome_type":"secondary","measure":"Pain","time_frame":"Post-operative day 3","description":"VAS pain score"},{"outcome_type":"primary","measure":"Subjective neurosensory disturbance","time_frame":"Baseline","description":"VAS score of numbness / hyperaesthesia"},{"outcome_type":"primary","measure":"Subjective neurosensory disturbance","time_frame":"Post-operative 1 week","description":"VAS score of numbness / hyperaesthesia"},{"outcome_type":"primary","measure":"Subjective neurosensory disturbance","time_frame":"Post-operative 1 month","description":"VAS score of numbness / hyperaesthesia"},{"outcome_type":"primary","measure":"Subjective neurosensory disturbance","time_frame":"Post-operative 3 months","description":"VAS score of numbness / hyperaesthesia"},{"outcome_type":"primary","measure":"Subjective neurosensory disturbance","time_frame":"Post-operative 6 months","description":"VAS score of numbness / hyperaesthesia"},{"outcome_type":"primary","measure":"Objective neurosensory disturbance","time_frame":"Baseline","description":"Static light touch with Von Frey fibres; two-point discrimination; pin-prick pressure"},{"outcome_type":"primary","measure":"Objective neurosensory disturbance","time_frame":"Post-operative 1 week","description":"Static light touch with Von Frey fibres; two-point discrimination; pin-prick pressure"},{"outcome_type":"primary","measure":"Objective neurosensory disturbance","time_frame":"Post-operative 1 month","description":"Static light touch with Von Frey fibres; two-point discrimination; pin-prick pressure"},{"outcome_type":"primary","measure":"Objective neurosensory disturbance","time_frame":"Post-operative 3 months","description":"Static light touch with Von Frey fibres; two-point discrimination; pin-prick pressure"},{"outcome_type":"primary","measure":"Objective neurosensory disturbance","time_frame":"Post-operative 6 months","description":"Static light touch with Von Frey fibres; two-point discrimination; pin-prick pressure"},{"outcome_type":"primary","measure":"Biochemical analysis","time_frame":"Baseline","description":"Concentration of lipid peroxidase, superoxide dismutase, catalase, and glutathione peroxidase in plasma"},{"outcome_type":"primary","measure":"Biochemical analysis","time_frame":"Post-operative day 2","description":"Concentration of lipid peroxidase, superoxide dismutase, catalase, and glutathione peroxidase in plasma"},{"outcome_type":"secondary","measure":"Pain","time_frame":"Post-operative day 0","description":"VAS pain score; time to first analgesic intake and dosage"},{"outcome_type":"secondary","measure":"Pain","time_frame":"Post-operative day 1","description":"VAS pain score"},{"outcome_type":"secondary","measure":"Pain","time_frame":"Post-operative day 2","description":"VAS pain score"}]}
{"nct_id":"NCT02844439","start_date":"2016-06-30","phase":"Phase 2","enrollment":40,"brief_title":"Study of Tesevatinib Monotherapy in Patients With Recurrent Glioblastoma","official_title":"A Phase 2, Multicenter Study of Tesevatinib Monotherapy in Patients With Recurrent Glioblastoma","primary_completion_date":"2020-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-04-30","last_update":"2021-09-22","description":"This is a multicenter, Phase 2 study to assess the activity of tesevatinib in patients with recurrent glioblastoma.","other_id":"KD019-208","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Willingness and ability to provide written informed consent and to comply with the\r\n             study protocol as judged by the investigator\r\n\r\n          2. Age  18 years old\r\n\r\n          3. Kamofsky performance status 70%\r\n\r\n          4. Stable or decreasing dose of corticosteroids within 5 days prior to study 5.\r\n             enrollment.\r\n\r\n          5. For women who are not postmenopausal (i.e., < 12 months after last menstruation) or\r\n             surgically sterile (absence of ovaries and/or uterus) and who are sexually active:\r\n             agreement to use an adequate method of contraception (oral contraceptives,\r\n             intrauterine contraceptive device, barrier method of contraception in conjunction with\r\n             spermicidal jelly) during the treatment period and for at least 6 months after the\r\n             last dose of study drug.\r\n\r\n          6. For male patients who are sexually active and who are partners of premenopausal women:\r\n             agreement to use a barrier method of contraception during the treatment period and for\r\n             at least 6 months after the last dose of study drug.\r\n\r\n          7. Histologically confirmed glioblastoma. A local pathology report constitutes adequate\r\n             documentation of histology for study inclusion. Patients with an initial diagnosis of\r\n             a lower-grade glioma are eligible if a subsequent biopsy was determined to be\r\n             glioblastoma.\r\n\r\n          8. First recurrence after concurrent or adjuvant chemoradiotherapy. Imaging confirmation\r\n             of first tumor progression or regrowth as defined by the RANO criteria . A minimum of\r\n             12 weeks must have elapsed from the completion of radiotherapy to study entry to\r\n             minimize the potential for MRI changes related to radiation necrosis that might be\r\n             misdiagnosed as progression of disease, unless there is a new lesion outside the\r\n             radiation field or unequivocal evidence of viable tumor on histopathological sampling.\r\n\r\n          9. Prior treatment with TMZ for low grade glioma or glioblastoma.\r\n\r\n         10. No more than one prior line of systemic treatment for glioblastoma. Concurrent and\r\n             adjuvant TMZ-based chemotherapy, including the combination of TMZ with an\r\n             investigational agent, is considered one line of therapy.\r\n\r\n         11. Prior therapy with gamma knife or other focal high-dose radiotherapy is allowed, but\r\n             the patient must have subsequent histologic documentation of recurrence, unless the\r\n             recurrence is a new lesion outside the irradiated field.\r\n\r\n         12. Recovery from the toxic effects of prior therapy, with a minimum time of:\r\n\r\n               1.  28 days elapsed from the administration of any prior cytotoxic agents, except \r\n                  14 days from vincristine,  21 days from procarbazine, and  42 days from\r\n                  nitrosureas\r\n\r\n               2.  28 days elapsed from the administration of any investigational agent\r\n\r\n               3.  14 days elapsed from administration of any non-cytotoxic agent (e.g.,\r\n                  interferon, tamoxifen, thalidomide, cis-retinoic acid)\r\n\r\n         13. Patients who have undergone recent surgery for recurrent or progressive tumor are\r\n             eligible provided that:\r\n\r\n               1. Surgery must have confirmed the recurrence\r\n\r\n               2. There must be residual disease\r\n\r\n               3. A minimum of 28 days must have elapsed from the day of surgery to first dose of\r\n                  the study drug. For core or needle biopsy, a minimum of 7 days must have elapsed\r\n                  prior to study entry\r\n\r\n         14. Availability of formalin-fixed paraffin-embedded tumor tissue diagnostic of\r\n             glioblastoma.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Concurrent therapeutic intervention (including radiation therapy and NovoTTF).\r\n\r\n          2. Prior exposure to EGFR inhibitors.\r\n\r\n          3. Prior exposure to bevacizumab or other VEGF- or VEGF-receptor-targeted agent within 8\r\n             weeks of study start.\r\n\r\n          4. Prior treatment with prolifeprospan 20 with carmustine wafer.\r\n\r\n          5. Prior intracerebral agent.\r\n\r\n          6. Evidence of recent hemorrhage on baseline MRI of the brain. However, patients with\r\n             clinically asymptomatic presence of hemosiderin, resolving hemorrhagic changes related\r\n             to surgery, or presence of punctuate hemorrhage in the tumor are eligible.\r\n\r\n          7. Need for urgent palliative intervention for primary disease (e.g., rapidly increasing\r\n             intracranial pressure, impending herniation, uncontrolled seizures).\r\n\r\n          8. Hematology:\r\n\r\n             ANC < 1.5 x109/L; Plt < 100 x109/L Hgb < 9.0 g/dL within 7 days prior to enrollment.\r\n             The use of transfusion or other intervention to achieve Hb  9 g/dL is acceptable.\r\n\r\n          9. T.Bili.  1.5 x ULN (except in patients diagnosed with Gilbert's disease).\r\n\r\n         10. AST(SGOT), ALT(SGPT), or alkaline phosphatase (ALP)  2.5 x ULN.\r\n\r\n         11. S. Creat. > 1.5 x ULN.\r\n\r\n         12. K+ or Mg+ < LLN.\r\n\r\n         13. In the absence of therapeutic intent to anticoagulate the patient: INR > 1.5 or PT >\r\n             1.5 xULN or aPTT > 1.5 xULN Therapeutic anticoagulation.\r\n\r\n         14. Known contraindication to MRI, such as cardiac pacemaker, shrapnel or ocular foreign\r\n             body.\r\n\r\n         15. Used any prescription medication during the prior 2 weeks that the investigator judges\r\n             is likely to interfere with the study or to pose an additional risk to the patient in\r\n             participating, specifically inhibitors or inducers of cytochrome P450 (CYP)3A4 (refer\r\n             to Appendix 5). A stable regimen ( 4 weeks) of antidepressants of the selective\r\n             serotonin re-uptake inhibitor (SSRI) class is allowed (common SSRIs include\r\n             escitalopram oxalate, citalopram, fluvoxamine, paroxetine, sertraline, and\r\n             fluoxetine).\r\n\r\n         16. Taking any drugs associated with torsades de pointes or known to moderately or\r\n             severely prolong the QTc(F) interval\r\n\r\n         17. History of torsades de pointes, ventricular tachycardia or fibrillation, pathologic\r\n             sinus bradycardia (< 50 bpm), heart block (excluding first degree block, being PR\r\n             interval only), or congenital long QT syndrome. Patients with a history of atrial\r\n             arrhythmias should be discussed with the Medical Monitor.\r\n\r\n         18. Uncontrolled diabetes, as evidenced by fasting serum glucose level >200 mg/dL\r\n\r\n         19. New York Heart Association (NYHA) Grade II or greater congestive cardiac failure.\r\n\r\n         20. Has marked prolongation of QTc(F) interval at screening or baseline (QTc[F] interval >\r\n             470 msec) using the Fridericia method of correction for heart rate.\r\n\r\n         21. History of myocardial infarction (within 12 months) or unstable angina (within 6\r\n             months) prior to study enrolment.\r\n\r\n         22. History of stroke or transient ischemic attacks within 6 months prior to study\r\n             enrolment.\r\n\r\n         23. Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or\r\n             recent peripheral arterial thrombosis) within 6 months prior to study enrolment.\r\n\r\n         24. Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic\r\n             anticoagulation).\r\n\r\n         25. History of intracranial abscess within 6 months prior to study enrolment.\r\n\r\n         26. History of another malignancy in the previous 3 years, with a disease-free interval of\r\n             < 3 years. Patients with prior history of in situ cancer or basal or squamous cell\r\n             skin cancer are eligible.\r\n\r\n         27. Evidence of any active infection requiring hospitalization or IV antibiotics within 2\r\n             weeks prior to study enrolment.\r\n\r\n         28. Known hypersensitivity to any excipients of tesevatinib.\r\n\r\n         29. Inability to swallow or absorb orally-administered medication.\r\n      ","sponsor":"Kadmon Corporation, LLC","sponsor_type":"Industry","conditions":"Brain Tumor|Recurrent Glioblastoma|Glioblastoma","interventions":[{"intervention_type":"Drug","name":"Drug: Tesevatinib"}],"outcomes":[{"outcome_type":"secondary","measure":"Exposure to Tesevatinib: Overall Median","time_frame":"Until disease progression, unacceptable toxicity, subject or investigator decision, death, or up to 3 years, whichever occurred first","description":"Median amount of tesevatinib (mg) subjects received during the study"},{"outcome_type":"primary","measure":"Efficacy: Median Progression-free Survival (PFS) Rate at 6 Months (PFS-6)","time_frame":"6 months","description":"Proportion (%) of subjects who did not have progressive disease after treatment with tesevatinib at 6 months (PFS-6) after baseline"},{"outcome_type":"secondary","measure":"Efficacy: Median PFS","time_frame":"Until disease progression, unacceptable toxicity, subject or clinician decision to discontinue, death, or up to 3 years, whichever occurred first","description":"Median duration (months) of subjects who were progression-free of disease from baseline"},{"outcome_type":"secondary","measure":"Efficacy: Median Overall Survival Rate at 9 Months (OS-9)","time_frame":"9 months","description":"Median proportion (%) of subjects who survived 9 months after baseline"},{"outcome_type":"secondary","measure":"Efficacy: Median OS","time_frame":"Until unacceptable toxicity, subject or investigator decision to discontinue, death, or up to 3 years, whichever occurred first","description":"Median duration (months) subjects survived from baseline until death"},{"outcome_type":"secondary","measure":"Efficacy: Best Overall Response","time_frame":"Until disease progression, unacceptable toxicity, subject or investigator decision to discontinue, death, or up to 3 years, whichever occurred first","description":"Best overall response that subjects had to treatment with tesevatinib: complete response (CR), partial response (PR), stable disease (SD), or non-response/progressive disease (PD)"},{"outcome_type":"secondary","measure":"Efficacy: Objective Response Rate (ORR)","time_frame":"Until disease progression, unacceptable toxicity, subject or investigator decision to discontinue, death, or 3 years, whichever occurred first","description":"Proportion (%) of subjects who had either a complete response (CR) or a partial response (PR) to treatment with tesevatinib"},{"outcome_type":"secondary","measure":"Exposure to Tesevatinib: Overall Mean","time_frame":"Until disease progression, unacceptable toxicity, subject or investigator decision, death, or up to 3 years, whichever occurred first","description":"Mean total amount of tesevatinib (mg) subjects received during the study"},{"outcome_type":"secondary","measure":"Exposure to Tesevatinib: Mean Number of Cycles","time_frame":"Until disease progression, unacceptable toxicity, subject or investigator decision, death, or up to 3 years, whichever occurred first.","description":"Mean number of 28-day cycles of treatment with tesevatinib subjects received during the study"},{"outcome_type":"secondary","measure":"Exposure to Tesevatinib: Median Number of Cycles","time_frame":"Until disease progression, unacceptable toxicity, subject or investigator decision, death, or up to 3 years, whichever occurred first","description":"Median number of 28-day cycles of treatment with tesevatinib subjects received during the study"}]}
{"nct_id":"NCT02769442","start_date":"2016-06-30","phase":"N/A","enrollment":600,"brief_title":"Prospective, Randomized Controlled Comparison of TERUMO SurFlash Plus Versus BD Insyte Autoguard in an Urban ED","official_title":"Prospective, Randomized Controlled Comparison of TERUMO SurFlash Plus Versus BD Insyte Autoguard in an Urban ED","primary_completion_date":"2016-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-10-31","last_update":"2019-11-04","description":"A randomized prospective comparison of two FDA approved intravenous catheters in the emergency department setting. The Terumo SurFlash Plus offers novel technologies that promise to increase intravenous access success rates and decrease blood contamination of the insertion site. This study would analyze these properties in our busy, urban emergency department setting where time and safety of intravenous access are most critical.","other_id":"HP-00068278","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adult ED patient requiring an IV for clinical care\r\n\r\n          -  Hemodynamically stable: pulse >50 and <130, MAP>60\r\n\r\n          -  Willing to read (or be read to) the informed consent and participate in study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Medically unstable\r\n\r\n          -  Agitated or psychiatrically unstable\r\n\r\n          -  Lacking capacity to consent, such as with altered mental status.\r\n\r\n          -  Unable to speak and read English\r\n      ","sponsor":"University of Maryland, Baltimore","sponsor_type":"Other","conditions":"Catheters|Catheterization, Peripheral","interventions":[{"intervention_type":"Device","name":"Device: Terumo SurFlash Plus catheter"},{"intervention_type":"Device","name":"Device: BD Insyte Autoguard catheter"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants With First-skin Puncture Success","time_frame":"Within first minute of IV access","description":"First attempt success, defined as one skin puncture (redirection permitted) which allows for completion of a blood draw and/or flush without extravasation.\r\nGauge size\r\nPatient prior history of difficult IV access\r\nOperator type (ED Technician/Registered Nurse/Physician Assistant/Nurse Practitioner/Resident/Attending)\r\nOperator years of experience with IV access\r\nType of catheter used"},{"outcome_type":"secondary","measure":"Number of Participants With Blood Visible at Site of Insertion","time_frame":"Within first minute of IV access","description":"Compare the frequency of bleeding near the insertion site"}]}
{"nct_id":"NCT02926612","start_date":"2016-06-30","enrollment":250,"brief_title":"Pathogen Identification in Pediatric Hematopoietic Stem Cell Transplant Patients With Suspected Lower Respiratory Tract Infection","official_title":"Pathogen Identification in Pediatric Hematopoietic Stem Cell Transplant Patients With Suspected Lower Respiratory Tract Infection","primary_completion_date":"2019-12-31","study_type":"Observational","rec_status":"Unknown status","last_update":"2018-08-31","description":"This is a multicenter prospective collection of leftover respiratory tract secretions, paired blood and NP swabs, and clinical circumstances from pediatric HCT patients, followed by next generation genomic sequencing, transcriptome analysis, protein biomarker measurement, and statistical modeling.","other_id":"SUP1601","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","maximum_age":21,"population":"HCT recipients ages 21 years for whom lower respiratory secretions are being collected for\r\n        direct patient care.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients will be 21 years of age with a history of HCT of any type at any point in\r\n             the past, and are planned to undergo clinically-indicated collection of any lower\r\n             respiratory specimen, including but not limited to bronchoalveolar lavage (either via\r\n             a plugged telescoping catheter such as a CombiCath, or with fiberoptic bronchoscopy)\r\n             and tracheal aspirate.\r\n\r\n          -  For the purposes of this study, induced or spontaneous sputum is not considered a\r\n             lower respiratory tract specimen.\r\n\r\n          -  Patients may have any underlying indication for clinical testing of lower respiratory\r\n             secretions, including but not limited to suspected infection, non-infectious\r\n             inflammation, obstructive or restrictive lung disease, pulmonary edema, pleural\r\n             effusions, alveolar hemorrhage, aspiration, or pulmonary vascular disease.\r\n\r\n          -  Patients who have not undergone HCT but plan to undergo HCT in the future, hereafter\r\n             referred to as pre-HCT patients, may also be enrolled.\r\n\r\n          -  Pre-HCT patients must have intention to undergo stem cell transplantation in the\r\n             future and include but are not limited to patients with primary immunodeficiency,\r\n             patients with malignancy undergoing induction or consolidation chemotherapy, and HCT\r\n             patients with selected cell sources who are undergoing pre-transplant conditioning but\r\n             have not yet received their cellular infusion.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients will not be >21 years of age.\r\n\r\n          -  Patients who do not have a clinical indication for obtaining lower respiratory\r\n             secretions for testing as part of their direct patient care will be excluded.\r\n\r\n          -  Patients who do not have sufficient respiratory secretions remaining after collection\r\n             and aliquoting for indicated clinical tests ordered by the treating clinician will\r\n             also be excluded.\r\n\r\n          -  Patients who undergo lower respiratory testing solely to evaluate for relapsed\r\n             malignancy will be excluded.\r\n      ","sponsor":"Pediatric Blood and Marrow Transplant Foundation, Inc.","sponsor_type":"Other","conditions":"Lower Respiratory Tract Infections","interventions":[{"intervention_type":"Other","name":"Other: Next Generation Genomic Sequencing","description":"DNA and RNA are extracted from biospecimens, amplified, sequenced, and then compared to known microbe databases, allowing for quantitative identification of non-host organisms"}],"outcomes":[{"outcome_type":"primary","measure":"Evaluate and quantify the utility of NGS in improving the diagnosis of LRTI in pediatric HCT patients.","time_frame":"3 years"},{"outcome_type":"secondary","measure":"Evaluate the utility of human gene expression profiling in improving our understanding of host-microbe interactions in infectious and alloreactive pulmonary inflammation.","time_frame":"3 years"}]}
{"nct_id":"NCT02451202","start_date":"2016-06-30","phase":"Phase 4","enrollment":102,"brief_title":"Deep vs Moderate Neuromuscular Blockade With Rocuronium in Patients Undergoing Endolaryngeal Procedures","official_title":"A Comparison of Surgical Conditions Between Deep vs Moderate Neuromuscular Blockade With Rocuronium in Patients Undergoing Endolaryngeal Procedures.","primary_completion_date":"2018-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-03-31","last_update":"2020-01-07","description":"It is unknown the impact of deep neuromuscular paralysis and using a novel agent, sugammadex as an reversal in endolaryngeal surgery. We will conduct a clinical study aiming to compare two treatment strategies; Deep neuromuscular Blockade and moderate Neuromuscular Blockade. We hypothesize that deep NMB will offer better stillness. We will also descriptively examine if patients would be safely discharged from a recovery room.","other_id":"51815","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female aged 18 - 60 years; ASA I-III.\r\n\r\n          -  Subjects have been planned for elective endolaryngeal. Procedures (Direct Laryngoscopy\r\n             with laser (micro-)surgery in patients with Tis, T1, T2, supraglottis and glottis\r\n             carcinoma)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any renal impairment (CrCL < 80 ml/ min)\r\n\r\n          -  Any hepatic impairment; Child Pugh A, B or C\r\n\r\n          -  BMI > 30 kg m2\r\n\r\n          -  Known or suspected generalized neuromuscular disorders\r\n\r\n          -  Allergies to Rocuronium, Sugammadex, Sevoflurane, Propofol, fentanyl used during\r\n             general anesthesia\r\n\r\n          -  Hypersensitivity to the active substance or to any of the excipients\r\n\r\n          -  Female patient who are pregnant and breastfeeding.\r\n\r\n          -  Patient with poor Glasgow Coma Score and mental derangement who is unable to give\r\n             informed consent.\r\n\r\n          -  Patient with Tracheostomy tube.\r\n      ","sponsor":"Chulalongkorn University","sponsor_type":"Other","conditions":"Laryngoscopic Surgical Procedures","interventions":[{"intervention_type":"Procedure","name":"Procedure: Deep Neuromuscular Blockade","description":"During maintenance phase, if recovery after 1 Post-Tetanic-count (PTC) responses, a continuous infusion can be initiated to maintain deep NMB (TOF =0, PTC 1-2).\r\nAt the end of surgery, continuous infusion Rocuronium and Propofol are discontinued and paralysis will be simultaneously reversed by Sugammadex 4mg/kg from PTC 1-2."},{"intervention_type":"Procedure","name":"Procedure: Moderate Neuromuscular Blockade","description":"- During maintenance phase, if recovery at the presence of <10% of control T1 of TOF from initial doses of 0.6 mg rocuronium, a continuous infusion can be initiated to maintain TOF = 1 - 2. The initial pump rate will be set at 0.5 mg/kg per hour."},{"intervention_type":"Drug","name":"Drug: Sugammadex"},{"intervention_type":"Drug","name":"Drug: Rocuronium"}],"outcomes":[{"outcome_type":"primary","measure":"Proportion of Patients Who Have a Clinically Acceptable Surgical Conditions","time_frame":"intraoperative","description":"Proportion of patients who have a excellent and good surgical condition score"},{"outcome_type":"secondary","measure":"Time to Modified Aldrete's Score ≥ 9","time_frame":"Minutes from Post Anesthesia Care Unit (PACU) arrival to patients were considered fit for discharge from the PACU.","description":"Time from Post Anesthesia Care Unit (PACU) arrival to patients were considered fit for discharge from the PACU by Modified Aldrete's score assessment which scale range is from 0-10. Higher value represents a better outcome."}]}
{"nct_id":"NCT02804204","start_date":"2016-06-30","enrollment":200,"brief_title":"Serum Biomarkers Analysis in Patients With AR Treated With Anti-TMF","official_title":"Analysis of Circulant Rheumatoid Factor, Cyclic Citrullinated Anti-peptide Anti-bodies and Albumin as a Potential Predictor in the Response to the Treatment With Anti-TNF in Patients With Rheumatoid Arthritis","primary_completion_date":"2019-12-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2019-12-31","last_update":"2019-02-07","description":"Multicenter, prospective, observational study for evaluating if circulant rheumatoid factor, cyclic citrullinated anti-peptide anti-bodies and albumin can be used as potential predictors in the response to the treatment with anti-TNF in patients with rheumatoid arthritis after 24 weeks of treatment.","other_id":"SMB-CZP- 2014-03","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"Patients with rheumatoid arthritis according to the ACR criteria","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Both genders\r\n\r\n          -  Over 18 years old\r\n\r\n          -  Diagnosis of rheumatoid arthritis according to ACR criteria\r\n\r\n          -  Patients that initiate treatment with anti-TNF drugs according to clinical practice,\r\n             both in nave anti-TNF patients and patients after first anti-TNF failure\r\n\r\n          -  Patients able to follow the protocol requirements\r\n\r\n          -  Patients that signed the informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with known hypersensitivity to investigational products\r\n\r\n          -  Patients with tuberculosis, or severe infections like sepsis or opportunistic\r\n             infections\r\n\r\n          -  Patients with moderate/severe cardiac insufficiency (NHYA classification Class III/IV)\r\n\r\n          -  Patients that according to the investigator criteria can not participate in the study\r\n             or complete the study questionnaires\r\n\r\n          -  Pregnant or fertile woman that does not use a contraception method\r\n      ","sponsor":"Hospital Universitari Vall d'Hebron Research Institute","sponsor_type":"Other","conditions":"Rheumatoid Arthritis","interventions":[{"intervention_type":"Drug","name":"Drug: Anti-TNF"}],"outcomes":[{"outcome_type":"primary","measure":"Anti-TNF treatment response based on circulant rheumatoid factor","time_frame":"24 weeks"},{"outcome_type":"primary","measure":"Anti-TNF treatment response based on circulant cyclic citrullinated anti-peptide antibodies.","time_frame":"24 weeks"}]}
{"nct_id":"NCT02789436","start_date":"2016-06-30","phase":"Phase 4","enrollment":30,"brief_title":"Effect of Probiotic Lozenges on Halitosis in Patients With Chronic Periodontitis","official_title":"Effect of Probiotic Lactobacillus Reuteri-containing Lozenges (Prodentis) on Halitosis in Patients With Chronic Periodontitis","primary_completion_date":"2016-09-30","study_type":"Interventional","rec_status":"Unknown status","last_update":"2016-06-03","description":"The purpose of this study is to determine whether Lactobacillus reuteri-containing lozenges (Prodentis) are effective in treatment of halitosis in patients with chronic periodontitis.","other_id":"05-PA-26-10/15","allocation":"Randomized","intervention_model":"Parallel Assignment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":30,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adult patients, above age of 30\r\n\r\n          -  Non-smokers or ex-smokers (not smoking in the past year)\r\n\r\n          -  Moderate to advanced untreated chronic periodontitis\r\n\r\n          -  Good compliance and following of oral hygiene instructions\r\n\r\n          -  Halitosis in active phase and patient's subjective complaint\r\n\r\n          -  Informed consent by the patient\r\n\r\n        Exclusion Criteria\r\n\r\n          -  Aggressive periodontitis\r\n\r\n          -  Antibiotics administered up to 3 months prior to this study\r\n\r\n          -  Pregnancy and breastfeeding\r\n\r\n          -  Immunosuppressive therapy\r\n\r\n          -  Oral neoplasms (including radiation or chemotherapy)\r\n\r\n          -  Diabetes mellitus\r\n\r\n          -  Acute oral inflammation or infection\r\n\r\n          -  Poor, unsatisfactory oral hygiene and lack of compliance\r\n\r\n          -  Use of dietary supplements containing probiotics within 2 weeks prior to study start\r\n      ","sponsor":"University of Zagreb","sponsor_type":"Other","conditions":"Halitosis","interventions":[{"intervention_type":"Drug","name":"Drug: L. reuteri Prodentis lozenges","description":"Twice daily, for 28 days"},{"intervention_type":"Other","name":"Other: Placebo lozenges","description":"Twice daily, for 28 days"}],"outcomes":[{"outcome_type":"primary","measure":"Change in VSC concentration in mouth air","time_frame":"28 days","description":"Assessed with halimeter"},{"outcome_type":"secondary","measure":"Changes in halitosis associated quality of life","time_frame":"28 days","description":"Assessed with Halitosis Associated Life-quality Test (Kizhnev et al., 2011)"},{"outcome_type":"secondary","measure":"Change from Baseline in Plaque Accumulation (PCR)","time_frame":"28 days","description":"Assessed with PCR index (Plaque Control Record - O'Leary et al., 1972)"},{"outcome_type":"secondary","measure":"Change from Baseline in Bleeding on Probing (BOP)","time_frame":"28 days","description":"Assessed with BOP index (Bleeding on Probing, Ainamo and Bay, 1975)"}]}
{"nct_id":"NCT02819297","start_date":"2016-06-30","phase":"Phase 3","enrollment":1020,"brief_title":"BLI400-302: A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults","primary_completion_date":"2017-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-06-30","last_update":"2020-07-27","description":"The objective of this study is to evaluate a daily dose of BLI400 Laxative for safety and efficacy versus placebo in constipated adults.","other_id":"BLI400-302","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Male or female subjects at least 18 years of age\r\n\r\n          2. Constipated, defined by the following adapted ROME II definition\r\n\r\n             Fewer than 3 spontaneous defecations per week and at least one of the following\r\n             symptoms for at least 12 weeks (which need not be consecutive) in the preceding 12\r\n             months:\r\n\r\n               -  Straining during > 25% of defecations\r\n\r\n               -  Lumpy or hard stools in > 25% of defecations\r\n\r\n               -  Sensation of incomplete evacuation for > 25% of defecations\r\n\r\n          3. If female, and of child-bearing potential, is using an acceptable form of birth\r\n             control\r\n\r\n          4. Negative serum pregnancy test at screening, if applicable\r\n\r\n          5. In the Investigator's judgment, subject is mentally competent to provide informed\r\n             consent to participate in the study\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Report loose (mushy) or water stools in the absence of laxative use for more than 25%\r\n             of BMs during the 12 weeks before Visit 1\r\n\r\n          2. Meet the Rome II criteria for Irritable Bowel Syndrome.\r\n\r\n          3. Subjects with known or suspected ileus, gastrointestinal obstruction, gastric\r\n             retention, bowel perforation, toxic colitis, toxic megacolon\r\n\r\n          4. Subjects who have had major surgery 30 days before Visit 1; appendectomy or\r\n             cholecystectomy 60 days before Visit 1; abdominal, pelvic, or retroperitoneal surgery\r\n             6 months before Visit 1; bariatric surgery or surgery to remove a segment of the GI\r\n             tract at any time before Visit 1\r\n\r\n          5. Subjects with hypothyroidism that is being treated and for which the dose of thyroid\r\n             hormone has not been stable for at least 6 weeks at the time of Visit 1\r\n\r\n          6. Subjects taking laxatives, enemas or prokinetic agents that refuse to discontinue\r\n             these treatments from Visit 1 until after completion of the study\r\n\r\n          7. Subjects who are pregnant or lactating, or intend to become pregnant during the study\r\n\r\n          8. Subjects of childbearing potential who refuse a pregnancy test\r\n\r\n          9. Subjects who are allergic to any study medication component\r\n\r\n         10. Subjects taking narcotic analgesics or other medications known to cause constipation\r\n\r\n         11. Subjects with clinically significant cardiac abnormalities identified at the Visit 1\r\n             ECG\r\n\r\n         12. Subjects with clinically significant laboratory abnormalities, deemed as a potential\r\n             safety issue by the Investigator\r\n\r\n         13. Subjects who, in the opinion of the Investigator, should not be included in the study\r\n             for any reason, including inability to follow study procedures\r\n\r\n         14. Subjects who have participated in an investigational clinical, surgical, drug, or\r\n             device study within the past 30 days\r\n\r\n         15. Subjects with an active history of drug or alcohol abuse\r\n\r\n         16. Subjects have been hospitalized for a psychiatric condition or have made a suicide\r\n             attempt during the 2 years before Visit 1\r\n\r\n         17. Subjects who withdraw consent at any time prior to completion of Visit 1 procedures\r\n      ","sponsor":"Braintree Laboratories","sponsor_type":"Industry","conditions":"Constipation|Chronic Idiopathic Constipation|CIC","interventions":[{"intervention_type":"Drug","name":"Drug: BLI400 Laxative","description":"21 gm BLI400 powder"},{"intervention_type":"Drug","name":"Drug: BLI400 Placebo","description":"Equivalent amount of placebo powder"}],"outcomes":[{"outcome_type":"primary","measure":"Treatment Response","time_frame":"12 weeks","description":"The primary endpoint is the proportion of subjects who are weekly responders for at least 9 out of 12 weeks, with at least 3 of these weeks occurring in the last 4 weeks of treatment. A weekly responder is a subject who has ≥ 3 CSBMs and an increase from baseline of > 1 CSBM in that week."}]}
{"nct_id":"NCT02733224","start_date":"2016-06-30","enrollment":80,"brief_title":"Adherence to Lenalidomide Treatment in Multiple Myeloma - Prevalence, Characteristics and Clinical Significance","official_title":"Adherence to Lenalidomide Treatment in Multiple Myeloma - Prevalence, Characteristics and Clinical Significance","primary_completion_date":"2017-03-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2018-08-31","last_update":"2016-06-03","description":"we intend to evaluate the association between non-adherence to Lenalidomide in Multiple Myeloma (MM) patients and overall response rates and time to progression (TTP). Adherence will be measured in several ways, including by electronic monitoring, which is the gold standard method.","other_id":"0336-15","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":85,"population":"Patients diagnosed with active MM starting induction treatment with the lenalidomide with\r\n        or without dexamethasone, as any line of therapy.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients diagnosed with active MM\r\n\r\n          -  starting induction treatment with lenalidomide with or without dexamethasone\r\n\r\n          -  any line of therapy.\r\n\r\n        Exclusion Criteria:\r\n\r\n        * Treatment with any additional anti-myeloma drugs, during study period\r\n      ","sponsor":"Rabin Medical Center","sponsor_type":"Other","conditions":"Patient Non-adherence","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Response to treatment (Overall response) 4 weeks after finishing five months of electronic adherence monitoring (i.e. at 6 months).","time_frame":"within 4 weeks after 5 months of follow-up"}]}
{"nct_id":"NCT02610790","start_date":"2016-06-30","enrollment":50,"brief_title":"BRacelet And Physical actiVity Evaluation (BRAVE)","official_title":"Evaluation of Pre- and Post-operative Physical Activity on Postoperative Rehabilitation After Colorectal Surgery With a Connected Device","primary_completion_date":"2018-09-30","study_type":"Observational","rec_status":"Completed","completion_date":"2018-10-31","last_update":"2018-10-23","description":"The aim of this study is to quantify pre- and postoperative physical activity of patients operated on colorectal surgery. Daily physical activity (No. of footsteps) is going to be recorded from 15 days before surgery to the end of hospitalization after surgery in a prospective cohort of consecutive colorectal patients by use of an attached strap. Then, the investigators will propose physical activity thresholds (adapted to the age, gender and patient comorbidities) to optimize the ERAS protocol (Enhanced Rehabilitation After Surgery). Thus, this analysis will allow the investigators to provide patients with physical rehabilitation programs \"a la carte\" during a hospitalization for colorectal surgery. Connected bracelets will directly involve patients in their care and rehabilitation.","other_id":"383/15","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients who undergo colorectal surgery","criteria":"\n        Inclusion Criteria:\r\n\r\n        1. Patients with a colorectal surgery\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Limitation of linguistic or cognitive abilities, interfering with the understanding of\r\n             the study protocol\r\n\r\n          2. Lack of consent of the study form\r\n\r\n          3. Emergency Surgery\r\n\r\n          4. stoma closure\r\n      ","sponsor":"University of Lausanne Hospitals","sponsor_type":"Other","conditions":"Physical Activity","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Pre- and postoperative physical activity","time_frame":"30 days","description":"Number of footsteps"},{"outcome_type":"secondary","measure":"Quality of life","time_frame":"30 days","description":"score (number between 0 to 10)"},{"outcome_type":"secondary","measure":"Quality of sleep","time_frame":"30 days","description":"Score (number between 0 to 10)"},{"outcome_type":"secondary","measure":"Pain","time_frame":"30 days","description":"Score (number between 0 to 10)"},{"outcome_type":"secondary","measure":"Fatigue","time_frame":"30 days","description":"Score (number between 0 to 10)"}]}
{"nct_id":"NCT02739919","start_date":"2016-06-30","enrollment":6,"brief_title":"Bacterial Analysis of Kidney Stones Removed by Percutaneous Nephrolithotomy","official_title":"Bacterial Analysis of Kidney Stones Removed by Percutaneous Nephrolithotomy","primary_completion_date":"2017-02-23","study_type":"Observational","rec_status":"Completed","completion_date":"2017-02-24","last_update":"2018-05-02","description":"The aim of this research is to use a controlled laboratory setting to determine whether bacteria isolated from kidney stones of patients play a role in the formation of non-infectious kidney stones. It is well known that struvite stones are associated with active bacterial infection, however the role of bacteria in the formation of non-infection stones (like calcium oxalate) is not well characterized and there are theories that bacteria are involved in the making of these stones.","other_id":"H16-00637","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":19,"population":"Patients at Vancouver General Hospital that are diagnosed with a kidney stone and scheduled\r\n        to undergo percutaneous nephrolithotomy.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Over the age of 18\r\n\r\n          -  Diagnosed with or have a high index of suspicion of having a kidney stone and\r\n             scheduled to undergo percutaneous nephrolithotomy.\r\n\r\n          -  Medically fit for definitive surgical management of stone\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Those with medical comorbidities preventing them from safely undergoing definitive\r\n             surgical therapy.\r\n\r\n          -  Patients who are unable to provide informed consent.\r\n\r\n          -  18 years old or younger\r\n\r\n          -  Diagnosed with an infection stone\r\n\r\n          -  Urinary tract infection within 3 months before date of operation\r\n\r\n          -  Antibiotic use within 3 month before date of operation\r\n      ","sponsor":"University of British Columbia","sponsor_type":"Other","conditions":"Urolithiasis","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Amount of stone formation in artificial urine with isolated bacteria from non-infection kidney stones compared to control measured using FTIR-Microscopy and SEM (concentration measured in mg/mL).","time_frame":"Through study completion, approximately 2 years","description":"Bacteria will be isolated from non-infection kidney stones allowed to form a biofilm. Next, the bacteria will be incubated in supersaturated artificial urine to precipitate stone formation in vitro and compared to control urine consisting of the same artificial urine without bacteria. Over time, crystallization in the biofilm will be measured using FTIR-Microscopy and SEM."},{"outcome_type":"primary","measure":"Bacteria isolated from non-infection kidney stone compared to those identified on pre-operative urine test quantified by simple serial dilution and CFU counting (measured in CFU/mL) and identified using DNA sequencing.","time_frame":"Through study completion, approximately 2 years","description":"Bacteria will be quantified using simple serial dilution and CFU counting and identified using DNA sequencing. Bacteria will then be correlated with the bacteria identified on pre-operative urine test."}]}
{"nct_id":"NCT02819284","start_date":"2016-06-30","phase":"Phase 3","enrollment":909,"brief_title":"Safety and Efficacy of KPI-121 Compared to Placebo in Subjects With Dry Eye Disease","official_title":"A Phase 3, Double-Masked, Randomized, Controlled Study of KPI-121 0.25% Ophthalmic Suspension Compared to Vehicle in Subjects With Dry Eye Disease","primary_completion_date":"2017-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-09-30","last_update":"2021-01-05","description":"The primary purpose of this study is to determine the efficacy and safety of KPI-121 0.25% ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented clinical diagnosis of dry eye disease. The product will be studied over 14 days, with 1-2 drops instilled in each eye four times daily (QID).","other_id":"KPI-121-C-007","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Have a documented clinical diagnosis of dry eye disease in both eyes\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Known hypersensitivity or contraindication to the investigational product(s) or\r\n             components\r\n\r\n          -  History of glaucoma, IOP>21 mmHg at the screening or randomization visits, or being\r\n             treated for glaucoma in either eye.\r\n\r\n          -  Diagnosis of: ongoing ocular infection; severe/serious ocular condition that in\r\n             judgment of Investigator could confound study assessments or limit compliance; or have\r\n             been exposed to an investigational drug within 30 days prior to screening.\r\n\r\n          -  In the opinion of the Investigator or study coordinator, be unwilling or unable to\r\n             comply with study protocol or unable to successfully instill eye drops.\r\n      ","sponsor":"Kala Pharmaceuticals, Inc.","sponsor_type":"Industry","conditions":"Dry Eye Syndromes|Keratoconjunctivitis Sicca","interventions":[{"intervention_type":"Drug","name":"Drug: KPI-121 0.25% Ophthalmic Suspension"},{"intervention_type":"Drug","name":"Drug: Vehicle of KPI-121 0.25% Ophthalmic Suspension"}],"outcomes":[{"outcome_type":"primary","measure":"Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15)","time_frame":"Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)","description":"Comparison of mean change from baseline for bulbar conjunctival hyperemia in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-4 grading scale. The grading scale was based on the Cornea and Contact Lens Research Unit Grading Scale where 0 = none, 1 = very slight, 2 = slight, 3 = moderate and 4 = severe."},{"outcome_type":"primary","measure":"Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15)","time_frame":"Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)","description":"Comparison of mean ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse."},{"outcome_type":"secondary","measure":"Proportion of Subjects With ≥ 1 Unit Improvement From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia Worst Region at Visit 4 (Day 15)","time_frame":"Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)","description":"Proportion of subjects with ≥1 improvement from baseline in conjunctival hyperemia scores in the study eye. The grading scale was based on the Cornea and Contact Lens Research Unit Grading Scale where 0 = none, 1 = very slight, 2 = slight, 3 = moderate and 4 = severe."},{"outcome_type":"secondary","measure":"Change From Baseline/ Visit 2 (Day 1) in Ocular Discomfort Severity Scores at Visit 3 (Day 8)","time_frame":"Baseline/Visit 2 (Day 1) - Visit 3 (Day 8)","description":"Comparison of ocular discomfort scores between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse using 3-day mean scores."},{"outcome_type":"secondary","measure":"Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Scores to Day 4","time_frame":"Baseline/Visit 2 (Day 1) - Day 4","description":"Comparison of mean ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse."},{"outcome_type":"secondary","measure":"Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) in a Subgroup","time_frame":"Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)","description":"Comparison of mean ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse, in a sub-group of participants with more severe ocular discomfort at baseline, using 3 day means."},{"outcome_type":"secondary","measure":"Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity Scores at Day 3 (Diary)","time_frame":"Baseline/Visit 2 (Day 1) - Day 3","description":"Comparison of mean ocular discomfort severity between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse."},{"outcome_type":"secondary","measure":"Change From Baseline/Visit 2 (Day 1) in Eye Dryness Scores at Visit 4 (Day 15)","time_frame":"Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)","description":"Comparison of mean eye dryness between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse."},{"outcome_type":"secondary","measure":"Change From Baseline/Visit 2 (Day 1) in Eye Dryness Scores at Visit 3 (Day 8)","time_frame":"Baseline/Visit 2 (Day 1) - Visit 3 (Day 8)","description":"Comparison of mean eye dryness between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse."},{"outcome_type":"secondary","measure":"Ocular Discomfort Severity Scores on Day 2 (Diary) Minus Baseline/Visit 2 (Day 1)","time_frame":"Baseline/Visit 2 (Day 1) - Day 1","description":"Comparison of mean ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse."},{"outcome_type":"secondary","measure":"Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Frequency Scores at Visit 4 (Day 15)","time_frame":"Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)","description":"Comparison of mean ocular discomfort frequency between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse."},{"outcome_type":"secondary","measure":"Change From Baseline/Visit 2 (Day 1) in Subject-rated Ocular Discomfort Frequency Scores at Visit 3 (Day 8)","time_frame":"Baseline/Visit 2 (Day 1) - Visit 3 (Day 8)","description":"Comparison of mean ocular discomfort frequency between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse."},{"outcome_type":"secondary","measure":"Change From Baseline/Visit 2 (Day 1) in Inferior Corneal Fluorescein Staining Score at Visit 4 (Day 15)","time_frame":"Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)","description":"Comparison of mean corneal fluorescein staining in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using methods developed by the National Eye Institute (NEI) Dry Eye Workshop in evaluating 5 regions of the cornea (superior, inferior, nasal, temporal and central) using a 0-3 grading scale, where 0 = no visible staining, 1 = Mild, 2 = moderate and 3 = severe."},{"outcome_type":"secondary","measure":"Change From Baseline/Visit 2 (Day 1) in Nasal Corneal Fluorescein Staining Score at Visit 4 (Day 15)","time_frame":"Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)","description":"Comparison of mean nasal corneal fluorescein staining in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using methods developed by the National Eye Institute (NEI) Dry Eye Workshop in evaluating 5 regions of the cornea (superior, inferior, nasal, temporal and central) using a 0-3 grading scale, where 0 = no visible staining, 1 = Mild, 2 = moderate and 3 = severe."}]}
{"nct_id":"NCT02780518","start_date":"2016-06-30","phase":"N/A","enrollment":0,"brief_title":"Airvo/Optiflow High Flow Nasal Oxygenation During Microlaryngeal Surgery","official_title":"Airvo/Optiflow High Flow Nasal Oxygenation During Microlaryngeal Surgery - Assessing Effectiveness of Oxygenation and Carbon Dioxide Clearance","primary_completion_date":"2017-06-30","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2017-06-30","last_update":"2017-05-01","description":"Optiflow high flow nasal cannula (HFNC) oxygenation is a technique to provide oxygen to patients when they are paralysed under general anaesthesia. Their lungs are not moving, but the high flow allows oxygen to travel into their lungs. This is called 'apnoeic ventilation'. The investigators will be using this for patients undergoing surgery for their throat.","other_id":"1605 Airvo Optiflow","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":21,"maximum_age":99,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        1. Patients undergoing elective microlaryngeal surgery requiring general anaesthesia and\r\n        jet ventilation. They must have a physical status of the American Society of\r\n        Anesthesiologists (ASA) grade I/II and age 21 years or older.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients with history of previous difficult endotracheal intubation\r\n\r\n          2. Patients with two or more predictors of difficult mask ventilation or difficult\r\n             intubation or the combination of both\r\n\r\n          3. Patients with ASA grading of III and above are excluded from the study\r\n\r\n          4. Patients needing a rapid sequence induction for rapid securement of the airway\r\n\r\n          5. Pregnant women\r\n\r\n          6. Patients below the age of 21 years old\r\n\r\n          7. Patients unfit to give consent\r\n\r\n          8. Patients with nasal or sinus disease or problems\r\n\r\n          9. Patients with infective laryngeal disease e.g. papillomatosis\r\n      ","sponsor":"Singapore General Hospital","sponsor_type":"Other","conditions":"Throat Disorders","interventions":[{"intervention_type":"Device","name":"Device: Airvo","description":"Applying high flow nasal oxygen"}],"outcomes":[{"outcome_type":"primary","measure":"Number of patients with inadequate oxygenation as measured by pulse oximetry (SpO2<94%).","time_frame":"30 minutes","description":"Continuous pulse oximetry will be monitored for participants during the study."},{"outcome_type":"secondary","measure":"Number of patients with inadequate carbon dioxide clearance (end tidal CO2>55 mmHg)","time_frame":"30 minutes","description":"End tidal carbon dioxide will be measured by the sublgottic catheter already in situ in the trachea by continuous passive sampling and by intermittent low frequency jet ventilation"},{"outcome_type":"secondary","measure":"Number of participants with treatment-related adverse events as assessed by CTCAE v4.03","time_frame":"30 minutes","description":"The investigator will report the number of participants wtih adverse events that are related to treatment"}]}
{"nct_id":"NCT03410251","start_date":"2016-06-30","enrollment":17,"brief_title":"Long- Term Follow-up of Extraction Socket Management","official_title":"Long- Term Follow-up of Extraction Socket Management : Clinical Outcomes and Hard Tissue Changes","primary_completion_date":"2016-07-31","study_type":"Observational","rec_status":"Completed","completion_date":"2017-07-31","last_update":"2018-01-25","description":"Twenty-nine patients needing single tooth replacement in aesthetic area were treated by extraction and socket preservation with saddle connective tissue graft between September 2009 and February 2012. Computed Tomography scan were taken at baseline just after the surgery and 3 months later. Long- term evaluation of this particular socket management procedure was evaluated by recalling successfully seventeen of theses patients in June 2016. At this time, a clinical and radiographical consultation was done and Cone Beam CT was taken. Horizontal and vertical bone dimensional changes were then assessed thanks to 3D imaging analysis and esthetic and implants outcomes were evaluated.","other_id":"H2016-2 ExMA5","observational_model":"Other","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients were recruited from the Department of Periodontology and Oral Surgery of the\r\n        University of Lige, Belgium.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Good general health (ASA 1, 2)\r\n\r\n          -  Controlled periodontitis\r\n\r\n          -  >18 years of age or signed consent by the parents\r\n\r\n          -  Smoking history of<10 cigarettes per day\r\n\r\n          -  Signed informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnancy or lactation\r\n\r\n          -  Concurrent participation in another trial\r\n\r\n          -  Bone disease or the use of medications that interfered with bone metabolism\r\n\r\n          -  History of head and neck radio- therapy\r\n\r\n          -  Presence of dehiscence or fenestration on bone wall of the socket.\r\n      ","sponsor":"University of Liege","sponsor_type":"Other","conditions":"Tooth Loss","interventions":[{"intervention_type":"Procedure","name":"Procedure: Socket preservation","description":"Teeth were extracted atraumatically and without flap release in patients who have received prophylactic antibiotherapy and local anaesthesia. After checking the integrity of the buccal and palatal bone plate, biomaterial (Bio-Oss) was introduced into the socket. A connective tissue graft harvested from the palate was inserted and sutured in buccal and palatal pouches in order to cover the socket.\r\nchlorhexidine spray (0.12%) twice a day and Ibuprofen 600 mg three times/ day were prescribed whereas antibiotics were continued for 5 days. Tooth brushing was banned at the extraction site for 10 days and sutures were removed 10 days after surgery."}],"outcomes":[{"outcome_type":"secondary","measure":"Esthetic outcomes (VAS questionnaire)","time_frame":"Approximatively 6 years","description":"A VAS questionnaire was given to the patients in order to collect their opinion about the esthetic results."},{"outcome_type":"primary","measure":"Changes from Baseline Alveolar bone remodeling to 3 months and 6 year: horizontal measurements (based on CBCT, in mm)","time_frame":"Baseline, 3 months, 6 years","description":"The measurement were done by matching and superimposing CT scans using a three dimensional reconstruction software. Palatal horizontal measurements were calculated by subtracting the buccal horizontal measurements from the total horizontal measurements."},{"outcome_type":"primary","measure":"Changes from Baseline Alveolar bone remodeling to 3 months and 6 year : vertical measurements (based on CBCT, in mm)","time_frame":"Baseline, 3 months, 6 years","description":"The measurement were done by matching and superimposing CT scans using a three dimensional reconstruction software. One vertical measurement was taken on the buccal side, in parallel to the vertical reference line at mid distance between the buccal wall and reference line."},{"outcome_type":"secondary","measure":"Esthetic outcomes (PES questionnaire)","time_frame":"Approximatively 6 years","description":"At the cross- sectional long- term evaluation, to analyse the esthetic outcomes of the surgical procedure, the pink esthetic score (PES) was assessed (Fürhauser et al. 2005)"},{"outcome_type":"secondary","measure":"Implant survival rate (based on criteria of Buser et al., 1990)","time_frame":"Approximatively 6 years","description":"Success was defined according to the criteria of Buser et al., 1990 which are 1. absence of suppuration (recurring peri implant infection) 2. absence of persistent complaints like pain, foreign body sensation and/or dysesthesia 3. absence of continuous radioluncency area around the implant 4. absence of implant mobility."},{"outcome_type":"secondary","measure":"Peri-implant bone levels (based on periapical radiography, in mm)","time_frame":"Approximatively 6 years","description":"The peri- implant bone levels were assessed on periapical radiography using the parallell technique: the distance between the implant shoulder and the first bone to implant contact (DIB) was measured at the mesial and distal aspects using the specific software Image J64 (National Institutes of Health, Bethesda, MD, USA)."}]}
{"nct_id":"NCT02820519","start_date":"2016-06-30","phase":"Phase 2","enrollment":4,"brief_title":"Tolerability and Analgesic Efficacy of Loxapine in Patients With Refractory, Chemotherapy-induced Neuropathic Pain","official_title":"Tolerability and Analgesic Efficacy of Loxapine in Patients With Refractory, Chemotherapy-induced Neuropathic Pain","primary_completion_date":"2017-07-21","study_type":"Interventional","rec_status":"Terminated","completion_date":"2017-07-21","last_update":"2017-08-28","description":"Loxapine is an antipsychotic drug approved for the treatment of schizophrenia in several countries including the United States. In animal studies in mice, loxapine reduced neuropathic pain. Hence, in a proof-of-principle and dose-escalating study the tolerability and analgesic efficacy of loxapine will be evaluated in patients with neuropathic pain.","other_id":"LOX_2015_PILOT","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Primarily chemotherapy-induced neuropathic pain (including mixed pain) for at least 3\r\n             months refractory to at least one analgesic compound\r\n\r\n          -  Neuropathic pain >= 4 (11-point numeric pain scale) at screening visit (including\r\n             mixed pain)\r\n\r\n          -  Age >= 18 years\r\n\r\n          -  Body weight between 50 and 150 kg\r\n\r\n          -  Given written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Participation in other interventional clinical studies (currently or within the last 3\r\n             months)\r\n\r\n          -  Parkinson's disease, movement disorders (extrapyramidal signs and symptoms) associated\r\n             with antipsychotics, neuroleptic malignant syndrome, other syndromes associated with\r\n             antipsychotics\r\n\r\n          -  Severe hypotension with a syncope in history, glaucoma, urinary retention, epilepsy or\r\n             other seizure disorders in history, severe dementia, dementia-related psychosis in\r\n             history, malignancies with a life expectancy of less than 6 months, breast cancer in\r\n             history, other life-threatening conditions\r\n\r\n          -  Corrected QT interval (QTc) > 460 ms (females) or > 450 ms (males)\r\n\r\n          -  Known alcohol and/or drug abuse\r\n\r\n          -  Concomitant intake of antipsychotics, dopamine agonists (Levodopa, bromocriptine,\r\n             lisuride, pergolide, ropinirole, cabergoline, pramipexole, apomorphine),\r\n             alpha-receptor blocking compounds\r\n\r\n          -  Compounds with a strong evidence for a clinically relevant QT interval prolongation or\r\n             torsade de pointes risk increase\r\n\r\n          -  Strong inhibitors of CYP1A2, CYP2D6, or CYP3A4\r\n\r\n          -  Known CYP2D6 Poor metabolizer status\r\n\r\n          -  Pregnancy or lactation period\r\n\r\n          -  Missing or insufficient contraception in pre- or perimenopausal women\r\n\r\n          -  Close Affiliation with the investigational site\r\n      ","sponsor":"University of Witten/Herdecke","sponsor_type":"Other","conditions":"Neuropathic Pain","interventions":[{"intervention_type":"Drug","name":"Drug: Loxapine","description":"Loxapine dose escalation according to tolerability and analgesic efficacy"}],"outcomes":[{"outcome_type":"primary","measure":"Loxapine dosage with the lowest incidence of events.","time_frame":"After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57)","description":"The primary endpoint is defined as the first occurrence of a (serious) adverse event ((S)AE) leading to dose reduction or withdrawal of loxapine (\"event\"). The loxapine dosage with the lowest incidence of events will be identified."},{"outcome_type":"secondary","measure":"Number, type, and severity of (serious) adverse events ((S)AEs)","time_frame":"After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57)","description":"Number, type, and severity of (serious) adverse events ((S)AEs)"},{"outcome_type":"secondary","measure":"Cumulative incidence rates for (S)AE pattern of study participants","time_frame":"After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57)","description":"Cumulative incidence rates for (S)AE pattern of study participants"},{"outcome_type":"secondary","measure":"Individual (study participant-related) incidence of individual (S)AEs","time_frame":"After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57)","description":"Individual (study participant-related) incidence of individual (S)AEs"},{"outcome_type":"secondary","measure":"Individual (study participant-related) changes in pain severity (NRS scale)","time_frame":"After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57)","description":"Individual (study participant-related) changes in pain severity (measured by using 11-point numeric pain rating scale) in relation to treatment phase and loxapine dosage"},{"outcome_type":"secondary","measure":"Association between event pattern and individual pain level (NRS scale)","time_frame":"After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57)","description":"Assessment of the association between the pattern of events (Primary endpoint) related to the individual pain level (clinically relevant pain reduction is defined by an at least 30% decrease or an absolute decrease of two scale units compared to baseline using 11-point numeric pain rating scale."},{"outcome_type":"secondary","measure":"Individual (study participant-related) changes in pain severity (painDETECT)","time_frame":"After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57)","description":"Individual (study participant-related) changes in pain severity (measured by painDETECT questionnaire) in relation to treatment phase and loxapine dosage"},{"outcome_type":"secondary","measure":"Association between event pattern and individual pain level (painDETECT)","time_frame":"After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57)","description":"Assessment of the association between the pattern of events (Primary endpoint) related to the individual changes in pain severity / characteristics measured by painDETECT questionnaire"},{"outcome_type":"secondary","measure":"Individual (study participant-related) changes in QoL (SF-12v2)","time_frame":"After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57)","description":"Individual (study participant-related) changes in the quality of life (12-item Short Form Health Survey (SF-12v2)) in relation to treatment phase and loxapine dosage"},{"outcome_type":"secondary","measure":"Association between event pattern and QoL (SF-12v2)","time_frame":"After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57)","description":"Assessment of the association between the pattern of events (Primary endpoint) related to the individual quality of life changes changes (12-item Short Form Health Survey (SF-12v2))"},{"outcome_type":"secondary","measure":"Individual (study participant-related) changes in anxiety and depression (HADS-D scale)","time_frame":"After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57)","description":"Individual (study participant-related) changes in anxiety and depression (HADS-D scale) in relation to treatment phase and loxapine dosage"},{"outcome_type":"secondary","measure":"Association between event pattern and anxiety and depression (HADS-D scale)","time_frame":"After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57)","description":"Assessment of the association between the pattern of events (Primary endpoint) related to the individual changes in anxiety and depression (HADS-D scale)"},{"outcome_type":"secondary","measure":"Association between event pattern and analgesic co-medication","time_frame":"After each of the four 14 days study episodes (Day 15, Day 29, Day 43, Day 57)","description":"Assessment of the association between the pattern of events (Primary endpoint) related to the individual changes in analgesic co-medication"}]}
{"nct_id":"NCT03040154","start_date":"2016-06-30","phase":"N/A","enrollment":217,"brief_title":"Engaging Immigrants in Preventive Parenting Interventions","official_title":"Engaging Immigrants in Preventive Parenting Interventions","primary_completion_date":"2016-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-12-31","last_update":"2021-06-22","description":"The objective of this community-based randomized controlled trial is to evaluate the outcomes of a theory-based parent engagement intervention (i.e., culturally-tailored video) aimed at promoting the participation of Filipino parents and grandparents in an evidence-based preventive parenting intervention.","other_id":"CCI-13-00159","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  The sample will consist of Filipino parents and grandparents of children/grandchildren\r\n             between ages 6-12 years old. Inclusion criteria include:\r\n\r\n               1. the parent or grandparent has at least one child between 6 to 12 years of age\r\n\r\n               2. the participating parent/grandparent is Filipino\r\n\r\n               3. At least one parent/grandparent is willing to complete pre and post surveys and\r\n                  watch a brief video\r\n\r\n               4. the parent/grandparent is age 18 or older\r\n\r\n               5. English fluency\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Younger than 18 years of age\r\n\r\n          2. Does not speak English\r\n\r\n          3. Target child has a developmental disability such as Trisomy 21 or autism\r\n\r\n          4. Parent or grandparent plans to move out of the area within the next nine months\r\n      ","sponsor":"Children's Hospital Los Angeles","sponsor_type":"Other","conditions":"Health Behavior|Parenting|Social Acceptance","interventions":[{"intervention_type":"Other","name":"Other: Video Documentary entitled, \"Para Sa Kinabukasan ng Mga Anak (For Our Children's Future)\""},{"intervention_type":"Other","name":"Other: Usual Care Video that is publicly available"}],"outcomes":[{"outcome_type":"primary","measure":"Enrollment in Evidence-Based Parenting Program","time_frame":"Up to two years after completing the survey","description":"The number of participants from each arm who enrolled in the Incredible Years Parenting Program after completing this study. Enrollment in the parenting program helped determine if the culturally-tailored video intervention effectively increases program participation among Filipino parents."}]}
{"nct_id":"NCT02888600","start_date":"2016-06-28","phase":"N/A","enrollment":190,"brief_title":"Stress Management Training for Healthy Aging","official_title":"Stress Management Training for Healthy Aging","primary_completion_date":"2020-02-21","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-11-29","last_update":"2021-01-27","description":"This study is a two-arm randomized controlled trial comparing two 8-week stress management programs for reducing inflammation and improving well-being among older adults.","other_id":"1R01AT008685-01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":65,"maximum_age":93,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  English speaking\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  [Exclusion criteria are masked from public viewing until data collection is complete.\r\n             Please contact project managers.]\r\n      ","sponsor":"Carnegie Mellon University","sponsor_type":"Other","conditions":"Psychological Stress|Loneliness","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Mindfulness Training","description":"Guided mindfulness meditation and stress management training"},{"intervention_type":"Behavioral","name":"Behavioral: Health Education","description":"Guided health education and stress management training"}],"outcomes":[{"outcome_type":"primary","measure":"Circulating markers of inflammation, Interleukin-6 and C Reactive Protein","time_frame":"Change from baseline to 1-week post-intervention and 3-month follow-up","description":"Measured via blood samples"},{"outcome_type":"secondary","measure":"Pro-inflammatory gene expression","time_frame":"Change from baseline to 1-week post-intervention"},{"outcome_type":"secondary","measure":"Self-reported relational distress","time_frame":"Change from Baseline to Intervention Weeks 4 and 8","description":"Evaluated using ecological momentary assessment"},{"outcome_type":"secondary","measure":"Self-reported loneliness","time_frame":"Change from baseline to 1-week post-intervention and 3-month follow-up","description":"Evaluated using UCLA loneliness scale and ecological momentary assessment"},{"outcome_type":"other","measure":"Health practices","time_frame":"Change from baseline to 1-week post-intervention and 3-month follow-up","description":"Evaluated by questionnaires asking about diet, caffeine consumption, alcohol use, stress reduction, exercise, recreational drug use, cold or flu, flu shots"},{"outcome_type":"other","measure":"Mental health","time_frame":"Change from baseline to 1-week post-intervention and 3-month follow-up","description":"Evaluated using Beck Depression Inventory"},{"outcome_type":"other","measure":"Self-reported stress","time_frame":"Change from baseline to 1-week post-intervention and 3-month follow-up"},{"outcome_type":"other","measure":"Mindfulness","time_frame":"Change from baseline to 1-week post-intervention and 3-month follow-up","description":"Evaluated using Mindful Attention Awareness Scale"},{"outcome_type":"other","measure":"Connectedness to nature","time_frame":"Change from baseline to 1-week post-intervention and 3-month follow-up","description":"Evaluated using Nature Connection Scale"},{"outcome_type":"other","measure":"Personality","time_frame":"Change from baseline to 1-week post-intervention and 3-month follow-up","description":"Evaluated using NEO Personality Inventory"},{"outcome_type":"other","measure":"Social network and social support","time_frame":"Change from baseline to 1-week post-intervention and 3-month follow-up","description":"Evaluated using Social Network Index and Interpersonal Support Evaluation List"},{"outcome_type":"other","measure":"Self-reported psychological distress","time_frame":"Change from baseline to 1-week post-intervention and 3-month follow-up"},{"outcome_type":"other","measure":"Trait affect","time_frame":"Change from baseline to 1-week post-intervention and 3-month follow-up","description":"Evaluated using Stanford Measure of Actual, Ideal, and Avoided Affect"},{"outcome_type":"other","measure":"Trait hostility","time_frame":"Change from baseline to 1-week post-intervention and 3-month follow-up","description":"Evaluated using Cook-Medley Hostility Scale"},{"outcome_type":"other","measure":"Attachment style","time_frame":"Change from baseline to 1-week post-intervention and 3-month follow-up","description":"Evaluated using Adult Attachment Scale"},{"outcome_type":"other","measure":"Attitudes towards aging","time_frame":"Change from baseline to 1-week post-intervention and 3-month follow-up","description":"Evaluated using Attitudes to Aging Questionnaire"},{"outcome_type":"other","measure":"Resting thought listing","time_frame":"Assessed at baseline, 1-week post-intervention, and 3-month follow-up","description":"Participants will sit quietly for 5 minutes and report all noticed experiences and reactivity to those experiences"},{"outcome_type":"other","measure":"Immune functioning","time_frame":"Change from baseline to 1-week post-intervention and 3-month follow-up","description":"Assessed via stimulated IL-6 production and glucocorticoid resistance"},{"outcome_type":"other","measure":"Cellular aging","time_frame":"Change from baseline to 1-week post-intervention and 3-month follow-up","description":"Assessed via telomeres and telomerase"},{"outcome_type":"other","measure":"Markers of inflammation","time_frame":"Assessed at 3-month follow-up only","description":"Assessed via hair sample"},{"outcome_type":"other","measure":"Social interaction quality and quantity","time_frame":"Change from Baseline to Intervention Weeks 4 and 8","description":"Assessed via ecological momentary assessment"},{"outcome_type":"other","measure":"Self-reported psychological distress","time_frame":"Change from Baseline to Intervention Weeks 4 and 8","description":"Assessed via ecological momentary assessment"},{"outcome_type":"other","measure":"Home practice quality and quantity","time_frame":"Assessed daily throughout the eight-week intervention period","description":"Assessed by self-reported practice length, enjoyment of practice, usefulness of practice, trouble concentrating, mental fatigue, stress, and irritation during practice."},{"outcome_type":"other","measure":"Treatment expectations","time_frame":"Assessed prior to beginning of intervention, during Intervention Weeks 4 and 8","description":"Assessed by optimism about treatment and expectations for treatment outcome,"},{"outcome_type":"other","measure":"Instructor and class ratings","time_frame":"Assessed prior to beginning of intervention, during Intervention Weeks 4 and 8","description":"Assessed by self-report ratings of patient-provider connection"},{"outcome_type":"other","measure":"Sleep measures","time_frame":"Change from baseline through intervention to 1-week post-intervention and 3-month follow up","description":"Assessed by self-report ratings of sleep using Pittsburgh Sleep Quality Index"},{"outcome_type":"other","measure":"Physiological data (blood pressure, pulse rate)","time_frame":"Change from baseline to 1-week post-intervention and 3-month follow up","description":"Assessed by blood pressure cuffs in lab"},{"outcome_type":"other","measure":"Physiological data (gait)","time_frame":"1-week post-intervention and 3-month follow up","description":"Assessed by speed of walking at a normal pace"}]}
{"nct_id":"NCT02832674","start_date":"2016-06-25","phase":"N/A","enrollment":72,"brief_title":"Safety and Effectiveness Evaluation of the Device in Achieving Submental Lift","official_title":"An Open-Label, Single-Center, Single-Treatment, Safety and Effectiveness Evaluation of Percutaneous Radiofrequency in Achieving Submental Lift","primary_completion_date":"2017-02-20","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-04-08","last_update":"2018-05-01","description":"A prospective evaluation of the ThermiRF device in treating skin laxity under the chin and neck. Seventy male and female subjects between the age of 35 and 65 (inclusive) will be enrolled in this trial. The first 30 subjects will have a total of 6 study visits while the remainder will have a total of 5 study visits. All subjects will have a single treatment administered. The first 30 subjects will have an extra visit at Day 60 intended to allow collection of photo images post treatment to be used for the validation of three blinded raters. Photo images will be collected using 2D standard photography and 3D using the Vectra system. The architecture of the skin in the affected area will be measured using the Cutometer, a suction like instrument that measures elasticity. Sensory and safety will be measured using a 0-10 point numerical rating scale (NRS) and collection of safety reports. The study duration is approximately 6 months.","other_id":"THERMI_0005","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":35,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female between the age of 35 and 65 inclusive;\r\n\r\n          -  Mild to Moderate Skin Laxity Severity on the submental area defined as: \"normal\"\r\n             muscle, \"mild to moderate\" skin laxity and \"mild to moderate\" fat;\r\n\r\n          -  Desire to improve jawline definitions and/or submental skin lift\r\n\r\n          -  Body mass index (BMI) 30;\r\n\r\n          -  Females of childbearing potential who are sexually active must be willing to use an\r\n             approved method of birth control during study participation.\r\n\r\n          -  Cooperative, reliable, and able to read and comprehend English;\r\n\r\n          -  Able to read, understand, sign and date the informed consent document (English only);\r\n\r\n          -  Able and willing to comply with the schedule visit(s) and study requirements.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Excessive subcutaneous fat on the submental area\r\n\r\n          -  Use within 24 hours preceding surgery of ibuprofen, acetaminophen, any other\r\n             analgesics, anti-inflammatory products, or any products including herbals and\r\n             supplements that could interfere with the clinical assessments of this study (other\r\n             than drugs used for anesthesia);\r\n\r\n          -  History of cosmetic treatments on the face and neck including but not limited to:\r\n             facial skin tightening procedures within the past year, injectable fillers of any\r\n             type, Botox on the lower face, ablative resurfacing laser treatment, none ablative,\r\n             rejuvenative laser or light treatment within the past six months, deep facial peels,\r\n             dermabrasion, face lift, neck lift, blepharoplasty or brow lift, contour threads or\r\n             other.\r\n\r\n          -  History or current injury to the Head and Neck.\r\n\r\n          -  Severe solar elastosis\r\n\r\n          -  Clinically significant facial wounds, lesions or acute infections including cystic\r\n             acne, dermatitis, lupus or other immunodeficiency affecting the dermis\r\n\r\n          -  Presence of metal stents or facial implants\r\n\r\n          -  Pregnant or planning pregnancy prior to the end of study participation\r\n\r\n          -  Current or past history of smoking\r\n\r\n          -  History or current diagnosis of cancer of any type\r\n\r\n          -  History of uncontrolled cardiovascular disease(i.e. myocardial infarction,\r\n             hypertension, hypercholesterolemia, peripheral vascular disease, other)\r\n\r\n          -  Known hypersensitivity to local anesthetic medications\r\n\r\n          -  History, or current bleeding disorders (i.e. hemophilia or von Willebrand disease), or\r\n             anticipated treatment with prescription anticoagulants\r\n\r\n          -  Possesses a surgically implanted electronic device (i.e. pacemaker)\r\n\r\n          -  History of AIDs/HIV\r\n\r\n          -  Serious mental health illness such as dementia or schizophrenia; psychiatric\r\n             hospitalization in the past two years\r\n\r\n          -  Developmental disability or cognitive impairment that would preclude adequate\r\n             comprehension of the informed consent form and/or ability to follow study subject\r\n             requirement and/or record the necessary study measurements\r\n\r\n          -  A family member of the investigator or an employee of the investigator.\r\n\r\n          -  Participation in any other investigational study within 30 days prior to consent;\r\n      ","sponsor":"ThermiGen, LLC","sponsor_type":"Industry","conditions":"Skin Laxity","interventions":[{"intervention_type":"Device","name":"Device: Percutaneous Radiofrequency single treatment","description":"Percutaneous Radiofrequency single treatment' under controlled temperature conditions based on pre-defined amounts of energy as controlled by the device internal algorithm, and investigator expertise. Additionally, Hunsted solution will be infused in the treatment area to eliminate the electrode/fiber to touch inner layers of the skin. External temperatures (skin surface) will be monitored using a temperature reading camera to ensure the external temperature stays within acceptable levels during the procedure Ice packs will also be used as needed to cool the treatment area based on the Thermal Camera Reading where the . heat delivery may be exceeding the threshold."}],"outcomes":[{"outcome_type":"primary","measure":"Tissue Lift at the Submental Area Measuring >/= 20 mm2","time_frame":"Change from baseline at Day 90","description":"A >/= 20 mm^2 change from baseline at Day 90 as measured quantitatively using 3D photo images (a calculation)."},{"outcome_type":"secondary","measure":"Percent of Participants Rated as Improved or Not Improved as Scored by the Blinded Rater/Reviewer","time_frame":"Change from baseline to Days 90 and 180","description":"Overall improvement of submental lift was determined by a blinded rater panel using before and after photos"},{"outcome_type":"secondary","measure":"Physician Global Aesthetic Improvement Scale (P-GAIS)","time_frame":"Change from baseline at Days 90 and 180","description":"A subjective assessment of overall improvement measured by the physician using the PGAIS where the physician rates the appearance of the treated area (submental area) with respect to lift compared to baseline photography at the defined time points. The 5-point scale measures from \"Very much improved\" to \"worse\"."},{"outcome_type":"secondary","measure":"Subject Global Aesthetic Improvement Scale (S-GAIS)","time_frame":"Change from baseline at Days 90 and 180","description":"A subjective assessment of overall improvement measured by the participant using the SGAIS where the participant rates the appearance of the treated area (submental area) with respect to \"lift\"is measured from. the 5-point scale measures from Very much improved to worse."},{"outcome_type":"secondary","measure":"Physician Global Satisfaction Questionnaire (P-GSQ)","time_frame":"Change from baseline at Days 90 and 180","description":"A subjective assessment of global satisfaction as measured by the physician using the P-GSQ where the physician rates his/her level of satisfaction of the treatment and treated area based on 4 satisfaction questions respective to 1. changes to the treated area, 2. skin texture of the treated area, 3. satisfaction with treatment results and 4. likelihood to recommend the treatment as a treatment option."},{"outcome_type":"secondary","measure":"Subject Global Satisfaction Questionnaire (S-GSQ)","time_frame":"Change from baseline at Days 90 and 180","description":"A subjective assessment of global satisfaction as measured by the participant using the S-GSQ where the participant rates his/her level of satisfaction of the treatment and treated area based on 4 satisfaction questions respective to 1. changes to the treated area, 2. skin texture of the treated area, 3. satisfaction with treatment results and 4. likelihood to recommend the treatment as a treatment option."}]}
{"nct_id":"NCT02827370","start_date":"2016-06-16","phase":"N/A","enrollment":26,"brief_title":"CAREFOR: Precision Medicine Driving Precision Nutrition for the Treatment of NeoAdjuvant Breast Cancer","official_title":"CAREFOR Study: Precision Nutrition Caloric Restriction for Oncology Research: Precision Medicine Driving Precision Nutrition During Neoadjuvant Chemotherapy for Breast Cancer","primary_completion_date":"2019-07-01","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2022-04-30","last_update":"2021-06-04","description":"The purpose of the study is to determine if a targeted dietary change can enhance the effect of neo-adjuvant chemotherapy","other_id":"16D.067","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Pathologically proven invasive breast cancer\r\n\r\n          -  Planned neoadjuvant chemotherapy determined by the judgment of the medical oncologist\r\n\r\n          -  The patient must be female\r\n\r\n          -  Age  18\r\n\r\n          -  Non-metastatic and non-inflammatory breast cancer\r\n\r\n          -  History/physical examination, including breast exam and documentation of weight and\r\n             Karnofsky Performance Status of 80-100% for at least 60 days prior to study entry.\r\n\r\n          -  Women of childbearing potential must be non-pregnant and non-lactating and willing to\r\n             use medically acceptable form of contraception during chemotherapy\r\n\r\n          -  Patient must capable of and provide study specific informed consent prior to study\r\n             entry\r\n\r\n          -  BMI 21\r\n\r\n          -  Weight 120lbs\r\n\r\n          -  No prior history of non-breast malignancies in the past 1 year unless it was a non-\r\n             melanomatous skin lesion or carcinoma in situ of the cervix.\r\n\r\n          -  Patient must not have Acquired Immune Deficiency Syndrome (AIDS) or HIV positive based\r\n             upon current CDC definition; note, however, that HIV testing is not required for entry\r\n             into this protocol. The need to exclude patients with AIDS or HIV from this protocol\r\n             is necessary because anti-retrovirals may alter patient metabolism.\r\n\r\n          -  Patient may not have any active Gastrointestinal/Malabsorption disorder at the\r\n             discretion of the Principal Investigator which may include:\r\n\r\n          -  Chronic Pancreatitis\r\n\r\n          -  Chronic Diarrhea or Vomiting\r\n\r\n          -  Active Eating Disorder\r\n\r\n          -  No history of or current active drug/alcohol dependence.\r\n\r\n          -  No patients with decisional impairment.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patient is male.\r\n\r\n          -  Age <18 years\r\n\r\n          -  Clinical stage IV cancer\r\n\r\n          -  Inflammatory breast cancer (T4d)\r\n\r\n          -  Women of childbearing potential with a positive serum beta hCG.\r\n\r\n          -  Decision impaired patients.\r\n\r\n          -  BMI < 21\r\n\r\n          -  Weight < 120lbs\r\n\r\n          -  Weight loss 10% in the last 3 mos\r\n\r\n          -  Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma\r\n             in situ of the cervix) unless disease free for a minimum of 1 year prior to\r\n             registration\r\n\r\n          -  Non-epithelial breast malignancies such as sarcoma or lymphoma\r\n\r\n          -  Active Gastrointestinal/Malabsorption disorder at the discretion of the Principal\r\n             -Investigator which may include:\r\n\r\n               -  Chronic Diarrhea or Vomiting\r\n\r\n               -  Active Eating Disorder\r\n\r\n               -  Active drug/alcohol dependence or abuse history.\r\n      ","sponsor":"Sidney Kimmel Cancer Center at Thomas Jefferson University","sponsor_type":"Other","conditions":"Breast Carcinoma","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Behavioral Dietary Intervention","description":"Receive dietary counseling"}],"outcomes":[{"outcome_type":"primary","measure":"Pathologic complete response assessed in tissue","time_frame":"At time of definitive breast surgery","description":"The portion of patients who adhere to the diet restriction will be computed along with a 95% exact confidence. An exact binomial test (with a onesided alpha of 0.05) will also be used to test whether adherence is greater than 60%."},{"outcome_type":"primary","measure":"Incidence of adverse events evaluated by CTCAE version 4.0","time_frame":"Up to 24 months"},{"outcome_type":"secondary","measure":"Number of study participants who receive the dietary intervention to the historical controls","time_frame":"Up to 24 months","description":"Will be compared to historical controls. Will be based on logistic regression, which will control for patient characteristics and clinical factors. The study has 81% power to detect an odds ratio of about 0.25 using a 2-sided alpha of 0.05"},{"outcome_type":"secondary","measure":"Weight changes","time_frame":"Up to 24 months","description":"Will be assessed by modeling body mass index as a function of time via mixed-effects regression."},{"outcome_type":"secondary","measure":"Change in insulin","time_frame":"Up to 24 months","description":"Will be assessed as a function of time via mixed-effects regression."},{"outcome_type":"secondary","measure":"Change in serum","time_frame":"Up to 24 months","description":"Will be assessed as a function of time via mixed-effects regression."},{"outcome_type":"secondary","measure":"Distant metastases","time_frame":"Up to 24 months","description":"Will be analyzed via the Kaplan-Meier method and the logrank test."},{"outcome_type":"secondary","measure":"Progression-free survival","time_frame":"Up to 24 months","description":"Kaplan-Meier curves will be generated and a log-rank value will be calculated."},{"outcome_type":"secondary","measure":"Overall survival","time_frame":"Up to 24 months","description":"Will be analyzed with the Kaplan-Meier method and Cox proportional hazards regression."}]}
{"nct_id":"NCT02734160","start_date":"2016-06-15","phase":"Phase 1","enrollment":37,"brief_title":"A Study of Galunisertib (LY2157299) and Durvalumab (MEDI4736) in Participants With Metastatic Pancreatic Cancer","official_title":"A Phase 1b Dose-Escalation and Cohort-Expansion Study of the Safety, Tolerability, and Efficacy of a Novel Transforming Growth Factor- Receptor I Kinase Inhibitor (Galunisertib) Administered in Combination With the Anti-PD-L1 Antibody Durvalumab (MEDI4736) in Recurrent or Refractory Metastatic Pancreatic Cancer","primary_completion_date":"2018-08-02","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-04-17","last_update":"2019-08-05","description":"The main purpose of this study is to evaluate the safety and efficacy of the study drug known as galunisertib administered in combination with the anti-programmed cell death-ligand 1 (PD-L1) antibody durvalumab in participants with refractory metastatic pancreatic cancer.","other_id":"15784","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Must have histologic or cytologic confirmation of recurrent metastatic pancreatic\r\n             adenocarcinoma based on standard diagnostic criteria. Recurrence must be documented by\r\n             diagnostic biopsy.\r\n\r\n          -  Have measurable disease as defined by Response Evaluation Criteria in Solid Tumours\r\n             (RECIST) version 1.1.\r\n\r\n          -  Have had disease progression, been refractory or intolerant to no more than 2 prior\r\n             systemic regimens for locally advanced or metastatic pancreatic cancer. Participants\r\n             who have received prior neoadjuvant therapy and who now have metastatic disease must\r\n             have received 1 of the following for their metastatic disease: FOLFIRINOX,\r\n             nanoparticle albumin-bound paclitaxel/gemcitabine, TS-1 (tegafur gimeracil oteracil\r\n             potassium), irinotecan liposome injection/5-fluorouracil (5FU)/Leucovorin or\r\n             single-agent gemcitabine prior to enrolment in this study.\r\n\r\n          -  Dose Escalation: Able and willing to give valid written consent to undergo a new\r\n             tumour biopsy (prior to study treatment) or to provide an available archival tumour\r\n             sample if taken <3 years prior to enrolment if a new tumour biopsy is not feasible\r\n             with an acceptable clinical risk.\r\n\r\n          -  Cohort Expansion: Able and willing to give valid written consent to undergo a new\r\n             tumour biopsy (prior to study treatment). Able and willing to undergo a second tumour\r\n             biopsy on treatment. Where possible, tumour lesions used for new biopsies should not\r\n             be the same lesions used as RECIST target lesions, unless there are no other lesions\r\n             suitable for biopsy. Archival samples may be required if there is inadequate tissue in\r\n             the biopsy specimen.\r\n\r\n          -  Have adequate organ function.\r\n\r\n          -  Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)\r\n             scale.\r\n\r\n          -  Use approved contraceptive methods.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Have moderate or severe cardiovascular disease:\r\n\r\n               -  Have the presence of cardiac disease, including a myocardial infarction within 6\r\n                  months prior to study entry, unstable angina pectoris, New York Heart Association\r\n                  Class III/IV congestive heart failure, or uncontrolled hypertension.\r\n\r\n               -  Have documented major electrocardiogram (ECG) abnormalities (not responding to\r\n                  medical treatments; for example, atrial fibrillation, bundle branch blocks, or as\r\n                  approved by the sponsors).\r\n\r\n               -  Have major abnormalities documented by ECHO with Doppler (for example, moderate\r\n                  or severe heart valve function defect including moderate or severe valve stenosis\r\n                  or regurgitation, left ventricular ejection fraction <50%, evaluation based on\r\n                  the institutional lower limit of normal, septal aneurysm or other heart aneurysm,\r\n                  any aneurysm of the major vessels or any condition that results in increased risk\r\n                  of aneurysm (eg, Marfan syndrome, patent foramen ovale [PFO]).\r\n\r\n               -  Have predisposing conditions that are consistent with development of aneurysms of\r\n                  the ascending aorta or aortic stress (for example, family history of aneurysms,\r\n                  Marfan syndrome, PFO, bicuspid aortic valve, evidence of damage to the large\r\n                  vessels of the heart documented by computerized tomography [CT] scan with\r\n                  contrast or magnetic resonance imaging [MRI]).\r\n\r\n          -  Have evidence of interstitial lung disease that is symptomatic or may interfere with\r\n             the detection or management of suspected drug-related pulmonary toxicity or active,\r\n             noninfectious pneumonitis.\r\n      ","sponsor":"Eli Lilly and Company","sponsor_type":"Industry","conditions":"Metastatic Pancreatic Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Galunisertib","description":"Administered orally"},{"intervention_type":"Drug","name":"Drug: Durvalumab","description":"Administered IV"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants with Galunisertib in Combination with Durvalumab Dose-Limiting Toxicities (DLTs)","time_frame":"Cycle 1 (28 Days)"},{"outcome_type":"secondary","measure":"Pharmacokinetics (PK): Maximum Concentration (Cmax) of Galunisertib","time_frame":"Predose Day 1 Cycle 1 through Predose Day 1 Cycle 7 (28 Day Cycles)"},{"outcome_type":"secondary","measure":"PK: Area Under the Curve (AUC) at Steady State of Galunisertib","time_frame":"Predose Day 1 Cycle 1 through Predose Day 1 Cycle 7 (28 Day Cycles)"},{"outcome_type":"secondary","measure":"PK: Minimum Concentration (Cmin) of Durvalumab","time_frame":"Predose Day 1 Cycle 1 through Predose Day 1 Cycle 7 (28 Day Cycles)"},{"outcome_type":"secondary","measure":"Number of Participants with Anti-Durvalumab Antibodies","time_frame":"Predose Day 1 Cycle 2 through Predose Day 1 Cycle 4 (28 Day Cycles)"},{"outcome_type":"secondary","measure":"Progression-free Survival (PFS)","time_frame":"Baseline to Objective Progressive Disease or Death (Estimated up to 18 Months)"},{"outcome_type":"secondary","measure":"Objective Response Rate (ORR): Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR)","time_frame":"Baseline to Objective Progressive Disease (Estimated up to 18 Months)"},{"outcome_type":"secondary","measure":"Duration of Response (DoR)","time_frame":"Date of CR or PR to Date of Objective Progressive Disease or Death Due to Any Cause (Estimated up to 18 Months)"},{"outcome_type":"secondary","measure":"Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and Stable Disease (SD)","time_frame":"Baseline to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Estimated up to 18 Months)"},{"outcome_type":"secondary","measure":"Time to Response","time_frame":"Baseline to Date of CR or PR (Estimated up to 4 Months)"},{"outcome_type":"secondary","measure":"Overall Survival (OS)","time_frame":"Baseline to Date of Death from Any Cause (Estimated up to 30 Months)"}]}
{"nct_id":"NCT03635346","start_date":"2016-06-03","enrollment":128,"brief_title":"Medicinal Dependence and Chronic Pain: Addictive Evaluation in CETD","official_title":"Medicinal Dependence and Chronic Pain: Addictive Evaluation in CETD","primary_completion_date":"2016-09-03","study_type":"Observational","rec_status":"Completed","completion_date":"2018-03-10","last_update":"2018-08-17","description":"prescription opioid misuse in chronic pain is a growing public health concern. few studies got interested in prevalence of misuse and of opiate use disorder in a population of patients with a non cancer chronic pain. the investigators analyzed during 3 months opiate misuse and opiate ude disorder in a population of patients consulting a center specialized in pain management.","other_id":"DEMDOU 2016.CE13","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":85,"population":"analysis of SUD criteria in a population with a chronic pain (non cancer) , consulting a\r\n        center specialized in pain mangement","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  patient with a non cancer chronic pain\r\n\r\n          -  consulting a CETD center\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  non understanding of french\r\n      ","sponsor":"University Hospital, Brest","sponsor_type":"Other","conditions":"Opiate Dependence|Chronic Pain","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"DSM 5 criteria of SUD","time_frame":"Day 0 (at the inclusion)","description":"11 criteria of SUD"}]}
{"nct_id":"NCT04722120","start_date":"2016-06-01","phase":"N/A","enrollment":68,"brief_title":"Low Contrast Agent and Radiation Dose Protocol for Liver CT in Patients With HCC","official_title":"Low Contrast Agent and Radiation Dose Protocol for Liver CT Using IQon Spectral CT and IR Algorithm in Patients Who Received RFA for HCC: Prospective, Randomized, Single Blinded - Preliminary Study","primary_completion_date":"2018-01-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2021-01-01","last_update":"2021-01-25","description":"The purpose of this study is to test non-inferiority of spectral CT with low contrast agent and low radiation dose, compare to conventional liver CT in surveillance of hepatocellular carcinoma (HCC) in high-risk patient.","other_id":"SNUH-2016-2272","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Diagnostic","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Liver cirrhosis\r\n\r\n          -  Tumor marker (aFP, PIVKA) elevation\r\n\r\n          -  Nodular lesion on USG\r\n\r\n          -  Received RFA for HCC\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  hypersensitivity at iodine\r\n\r\n          -  GFR under 30\r\n\r\n          -  BMI over 30\r\n\r\n          -  Nursing or pregnant women\r\n\r\n          -  enrolled the other study\r\n      ","sponsor":"Seoul National University Hospital","sponsor_type":"Other","conditions":"Hepatocellular Carcinoma","interventions":[{"intervention_type":"Radiation","name":"Radiation: Low radiation dose CT","description":"Underwent spectral CT with 30% lower radiation dose"},{"intervention_type":"Radiation","name":"Radiation: Conventional CT (radiation)","description":"Underwent spectral CT without change of radiation."},{"intervention_type":"Drug","name":"Drug: Low contrast dose CT","description":"Underwent spectral CT 20% lower dose contrast media."},{"intervention_type":"Drug","name":"Drug: Conventional CT (contrast agent)","description":"Underwent spectral CT without change of contrast media doses."}],"outcomes":[{"outcome_type":"primary","measure":"Sensitivity and specificity for detection HCC","time_frame":"12 months after last patient's image work up","description":"diagnostic performance"},{"outcome_type":"primary","measure":"Quantitative image quality analysis","time_frame":"Immediate after study enrollement","description":"Contrast-to-Noise"}]}
{"nct_id":"NCT03552887","start_date":"2016-06-01","enrollment":323,"brief_title":"Adverse Events During Physiotherapy at Intensive Care Unit In Patients Undergoing Cardiac Surgery","official_title":"Adverse Events During Physiotherapy at Intensive Care Unit In Patients Undergoing Cardiac Surgery","primary_completion_date":"2017-11-30","study_type":"Observational","rec_status":"Completed","completion_date":"2017-11-30","last_update":"2018-06-25","description":"This study aims to estimate the incidence of adverse events during physiotherapy at intensive care unit (ICU) in adult patients undergoing cardiac surgery and to identify predictors of those events. This is a prospective cohort study, and the investigators observed all types of physiotherapy interventions in patients admitted at surgical ICU.","other_id":"1391854","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Adult patients admitted at surgical ICU, undergoing cardiac surgery, and who had receive\r\n        any physiotherapy intervention, at Instituto do Coracao - Hospital das Clinicas da\r\n        Faculdade de Medicina da Universidade de Sao Paulo, Brazil","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients undergoing cardiac surgery\r\n\r\n          -  Age  18 years old\r\n\r\n          -  Patients who are receiving any physiotherapy intervention\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Neurological and cognitive impairment\r\n      ","sponsor":"University of Sao Paulo General Hospital","sponsor_type":"Other","conditions":"Adverse Event|Physiotherapy|Intensive Care Units|Cardiac Surgery|Postoperative","interventions":[{"intervention_type":"Procedure","name":"Procedure: Cardiac Surgery","description":"Any type of cardiac surgery"},{"intervention_type":"Procedure","name":"Procedure: Physiotherapy","description":"Any type of physiotherapy intervention, performed by physiotherapists outside of the protocol"}],"outcomes":[{"outcome_type":"primary","measure":"Adverse Event","time_frame":"until date of ICU discharge or date of death from any cause, whichever came first, up to 24 months","description":"Occurrence of adverse events during all physiotherapy interventions."},{"outcome_type":"secondary","measure":"Grade of adverse event","time_frame":"until date of ICU discharge or date of death from any cause, whichever came first, up to 24 months","description":"Grade of observed adverse event according to the symptomatic consequences for the patient, from grade 1 (\"near miss\", additional intervention not required) to grade 5 (death)"},{"outcome_type":"secondary","measure":"Mortality Rate","time_frame":"Until hospital discharge, up to 24 months","description":"Number of deaths"},{"outcome_type":"secondary","measure":"ICU Length of Stay","time_frame":"Until ICU discharge, up to 24 months","description":"Number of days in ICU"},{"outcome_type":"secondary","measure":"Hospital Length of Stay","time_frame":"Until hospital discharge, up to 24 months","description":"Number of days in hospital"}]}
{"nct_id":"NCT02837484","start_date":"2016-05-31","phase":"N/A","enrollment":10,"brief_title":"NuTech Affinity for the Treatment of Chondral Defects","official_title":"The NuTech Affinity Membrane Product Evaluation for the Treatment of Chondral Defects","primary_completion_date":"2020-10-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2020-10-31","last_update":"2020-01-18","description":"This study was designed to evaluate the long term effectiveness of a product used in knee surgery called Affinity Membrane.","other_id":"RD2015-11-04","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Voluntary signature of the IRB (Institutional Review Board) approved Informed Consent\r\n\r\n          2. Male or female participants between the ages of 18-55\r\n\r\n          3. If female:\r\n\r\n               1. Actively practicing a contraception method, or\r\n\r\n               2. Practicing abstinence, or\r\n\r\n               3. Surgically sterilized, or\r\n\r\n               4. Postmenopausal\r\n\r\n          4. Pretreatment arthroscopic confirmation indicating one or two contained or uncontained\r\n             lesion(s) and equal to an ICRS Grade 3a, 3b, 3c, 3d of the femoral condyle or\r\n             trochlear groove and OCD (Osteohondritis dissecans) lesions (Grade 4a) with healed\r\n             bone base, which is non-sclerotic and no loss of bone greater than 6mm measured from\r\n             the surrounding subchondral plate. Original pretreatment arthroscopic confirmation\r\n             indicates that one or two lesion(s) are equal to an ICRS (Internation Cartilage Repair\r\n             Society) Grade 3a, 3b, 3c, 3d contained lesion(s) that is equivalent to an Outerbridge\r\n             Grade III or IV (greater than 50% loss of articular cartilage).\r\n\r\n          5. Has peripheral cartilage debridement to healthy cartilage that results in a lesion (s)\r\n             with an area of > or = 1cm ^2 and < or = 5 cm^2.\r\n\r\n          6. PCL (Posterior Cruciate Ligament), LCL (Lateral Collateral Ligament) and MCL (Medical\r\n             Collateral Ligament) in the affected knee are stable and the ACL (Anterior Cruciate\r\n             Ligament) is stable or can be stabilized as a concomitant procedure.\r\n\r\n          7. Ipsilateral knee compartment has intact menisci (or requires partial meniscectomy\r\n             resulting in stable menisci). No less than 60 degrees meniscal volume retained.\r\n\r\n          8. The contralateral knee is asymptomatic, stable, and fully functional.\r\n\r\n          9. Must be physically and mentally willing and able to comply with post-operative\r\n             rehabilitation and routinely scheduled clinical and radiographic visit through 24\r\n             months.\r\n\r\n         10. Alignment: Mechanical axis must be no more than 6 degrees from neutral.\r\n\r\n         11. Must be at least 3 months post previous surgery.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Clinical and/or radiographic disease diagnosis of the indexed affected joint that\r\n             Includes:\r\n\r\n               1. Osteoarthritis or avascular necrosis,\r\n\r\n               2. Rheumatoid arthritis, or history of septic or reactive arthritis,\r\n\r\n               3. Gout or history of gout or pseudogout in the affected knee,\r\n\r\n               4. Osteochondritis dissecans of the knee with significant bone loss (greater than 6\r\n                  mm deep measured from the subchondral plate)\r\n\r\n               5. Associated damage to the underlying subchondral bone requiring a bone graft\r\n\r\n          2. History of secondary arthropathies (i.e. sickle cell disease, hemochromatosis, or\r\n             autoimmune disease).\r\n\r\n          3. Uncontrolled diabetes.\r\n\r\n          4. Displays a high surgical risk due to unstable cardiac and/or pulmonary disease.\r\n\r\n          5. Has HIV or other immunodeficient state including subjects on immunosuppressant\r\n             therapies, or has significant illness (metastasis of any type) that decreases the\r\n             probability of survival to the 2 year endpoint.\r\n\r\n          6. Is at substantial risk for the need of organ transplantation, such as renal\r\n             insufficiency.\r\n\r\n          7. Is pregnant or breast-feeding.\r\n\r\n          8. Body mass index > 35.\r\n\r\n          9. Has bipolar articular cartilage involvement or kissing lesions of the ipsilateral\r\n             compartment, described as tibial or patellar lesions in the same compartment with\r\n             greater than ICRS Grade 2 chondrosis.\r\n\r\n         10. Is participating concurrently in another clinical trial, or has participated in a\r\n             clinical trial within 30 days of surgery.\r\n\r\n         11. Is receiving prescription pain medication other than NSAIDs or acetaminophen for\r\n             conditions unrelated to the index knee condition, chronic use of anticoagulants, or\r\n             taking corticosteroids.\r\n\r\n         12. Has a neuromuscular, neurosensory, or musculoskeletal deficiency that limits the\r\n             ability to perform objective functional assessment of either knee.\r\n\r\n         13. Active joint infection.\r\n\r\n         14. Prior total meniscectomy of either knee.\r\n\r\n         15. Radiographically has >5 degrees of malalignment as measured from the hip, knee and\r\n             ankle mechanical axis.\r\n\r\n         16. Has received within the past three months intra-articular hyaluronic acid therapy or\r\n             cortisone injections in the index knee.\r\n\r\n         17. Prior realignment surgery in the affected knee within the past 6 months.\r\n\r\n         18. Failed microfracture treatment performed less than 12-months before inclusion visit.\r\n\r\n         19. Is receiving workman's compensation or currently involved in litigation relating to\r\n             the index knee.\r\n\r\n         20. Has history of alcoholism, medication, or intravenous drug abuse, psychosis, is a\r\n             prisoner, has a personality disorder (s), poor motivation, emotional or intellectual\r\n             issues that would likely make the subject unreliable for the study, or any combination\r\n             of variables in the investigator's judgment that should exclude a potential subject.\r\n\r\n         21. Had or have an aneurysm clip implanted, intraocular foreign bodies (commonly seen in\r\n             welders), subcutaneous metal shards (found in sheet metal workers), or some shrapnel;\r\n             additionally no cardiac pacemaker, defibrillator, implanted neurostimulater (TENS\r\n             implants) some prosthetic heart valve (especially mitral valve), cochlear implant or\r\n             other hearing aide, or has a tendency of claustrophobia. Tattoos that may contain\r\n             iron-based dyes.\r\n      ","sponsor":"NuTech Medical, Inc","sponsor_type":"Industry","conditions":"Chondral Lesions|Cartilage","interventions":[{"intervention_type":"Other","name":"Other: NuTech Affinity Membrane","description":"NuTech Affinity Membrane is an aseptically produced hypothermically stored amniotic membrane patch."}],"outcomes":[{"outcome_type":"primary","measure":"Change from baseline for VAS scores","time_frame":"3 months, 6 months, 12 months 18 months, and 24 months"},{"outcome_type":"primary","measure":"Objective cartilage repair measured by MRI scanning","time_frame":"6 months, 12 months and 24 months"},{"outcome_type":"primary","measure":"Change from baseline of pain and functions scores on KOOS questionaire","time_frame":"3 months, 6 months, 12 months, 18 months and 24 months"},{"outcome_type":"secondary","measure":"Changes in patient-reported outcomes (PRO) questionnaires from baseline including IKDC (International Knee Documentation Committee)","time_frame":"3 months, 6 months, 12 months, 18 months and 24 months"},{"outcome_type":"secondary","measure":"Histological assessment of optional cartilage biopsies","time_frame":"24 months"}]}
{"nct_id":"NCT02998216","start_date":"2016-05-31","enrollment":20,"brief_title":"Pelvic Floor Symptoms After Bilateral Sacrospinous Fixation","official_title":"Pelvic Floor Symptoms and Patients Satisfaction After Bilateral Sacrospinous Fixation for the Primary Treatment of Pelvic Organ Prolapse ICS-POPQ Stage IV: A Prospective Observational Study","primary_completion_date":"2017-05-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2017-05-31","last_update":"2016-12-20","description":"This study aims to the assessment of pelvic floor symptoms and patients satisfaction after bilateral sacrospinous fixation for the primary treatment of pelvic organ prolapse stage IV.","other_id":"442/2016BO2","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"Female","minimum_age":18,"population":"All female patients who are planned to receive a bilateral sacrospinous fixation as a\r\n        treatment for pelvic organ prolapse Stage IV will be eligible for inclusion in the study.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  age 18 and above\r\n\r\n          -  pelvic organ prolapse ICS-POPQ Stage IV, with or without uterus\r\n\r\n          -  signed informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  gynecologic surgery in the three past months before planned surgery\r\n\r\n          -  history of prolapse surgery\r\n\r\n          -  participation in another study\r\n\r\n          -  need to simultaneously perform other surgical procedures (i.e. rectopexy)\r\n\r\n          -  ongoing chemotherapy of treatment with immunosuppressant drugs\r\n      ","sponsor":"University Hospital Tuebingen","sponsor_type":"Other","conditions":"Pelvic Organ Prolapse","interventions":[{"intervention_type":"Procedure","name":"Procedure: Bilateral sacrospinous fixation","description":"Bilateral sacrospinous vaginal suspension"}],"outcomes":[{"outcome_type":"primary","measure":"Assessment of pelvic floor symptoms","time_frame":"Twelve months","description":"Using the validated Germen Pelvic Floor Questionnaire (Baessler et al, Neurourol Urodynam 2004)"},{"outcome_type":"secondary","measure":"Anatomical outcome / Prolapse stage after surgery","time_frame":"Twelve months","description":"Using the POP-Q classification tool of the International Continence Society (Bump RC et al, Am J Obstet Gynecol 1996)"},{"outcome_type":"secondary","measure":"Changes in quality of life","time_frame":"Twelve months","description":"Germen Pelvic Floor Questionnaire (Baessler et al, Neurourol Urodynam 2004)"},{"outcome_type":"secondary","measure":"Changes in sexual activity","time_frame":"Twelve months","description":"Germen Pelvic Floor Questionnaire (Baessler et al, Neurourol Urodynam 2004)"}]}
{"nct_id":"NCT02758652","start_date":"2016-05-31","enrollment":160,"brief_title":"Molecular Mechanisms Leading to Chemoresistance in Epithelial Ovarian Cancer","official_title":"Molecular Mechanisms Leading to Chemoresistance in Epithelial Ovarian Cancer","primary_completion_date":"2026-04-30","study_type":"Observational","rec_status":"Active, not recruiting","completion_date":"2026-05-31","last_update":"2021-06-22","description":"Epithelial ovarian cancer is the most lethal gynecological malignancy in developed countries and the fifth most common cause of cancer-related death in women. Poor prognosis is due to challenges in early diagnosis and development of inevitable resistance to chemotherapy in majority of patients despite of good initial treatment response. The purpose of this prospective study is to analyze variation in microRNA expression in prediction of primary treatment response and the role of microRNAs in development of chemoresistance in epithelial ovarian cancer.  Objectives: To screen microRNAs from prospectively collected plasma, urine and tumor samples from patients diagnosed with epithelial ovarian cancer. Samples are analyzed for microRNA expression and differential expression is correlated with primary treatment response, progression-free survival and overall survival.  Methods: Plasma, urine and tumor samples are collected at primary surgery (open surgery or diagnostic laparoscopy) or interval debulking surgery, at 1st, 3rd and 6th neoadjuvant or adjuvant chemotherapy and at progression for high-throughput screening of microRNA expression by array technology.","other_id":"R15134","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"Female","minimum_age":18,"population":"Newly diagnosed epithelial ovarian cancer patients operated inTampere University Hospital,\r\n        Finland.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18 years of age, informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Informed consent not provided, age under 18 years.\r\n      ","sponsor":"Tampere University Hospital","sponsor_type":"Other","conditions":"Ovarian Cancer","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"miRNA expression profile as measured by miRNA array","time_frame":"5 years","description":"Expression profile calculated with bioinformatical analysis"},{"outcome_type":"secondary","measure":"Progression-free survival","time_frame":"5 years","description":"Time from diagnosis to disease relapse"},{"outcome_type":"secondary","measure":"Over-all survival","time_frame":"5 years","description":"Timo from diagnosis to death"}]}
{"nct_id":"NCT02033980","start_date":"2016-05-31","phase":"N/A","enrollment":400,"brief_title":"Efficacy of NICE Classification in the Histological Evaluation of Colorectal Lesions","official_title":"Efficacy of NICE Classification in the Histological Evaluation of Colorectal Lesions ----- a Multicenter Study in China","primary_completion_date":"2017-06-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2017-08-31","last_update":"2016-05-10","description":"Recently, a new category classification (NICE classification) using non-magnified NBI has been proposed. We design this multicenter study to evaluate the reliability and validity of the NICE classification in diagnosing colorectal polyps by Chinese endoscopists during both image and real-time process.","other_id":"rjxh[2013]125","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":90,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with colorectal lesions during colonoscopy examination\r\n\r\n          -  Informed consent available\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Suspect of advanced colorectal cancer\r\n\r\n          -  History of colorectal surgery, familial adenomatous polyposis or inflammatory bowel\r\n             disease\r\n\r\n          -  Poor bowel preparation\r\n\r\n          -  Patients under unsuitable conditions for examination or treatment, such as acute upper\r\n             gastrointestinal bleeding, noncorrectable coagulopathy, severe systemic disease, etc\r\n      ","sponsor":"Shanghai Jiao Tong University School of Medicine","sponsor_type":"Other","conditions":"Colorectal Polyps","interventions":[{"intervention_type":"Device","name":"Device: NBI","description":"All detected colorectal lesions will be examined by high-definition NBI. For type 2 and type 3 lesions, subsequent magnifying NBI examination will be performed."}],"outcomes":[{"outcome_type":"primary","measure":"Accuracy of NICE classification in histological prediction by gastroenterological fellows","time_frame":"within two weeks after polypectomy","description":"Diagnostic accuracy of gastroenterological fellows using non-magnified NBI according to NICE classification in histological prediction of polyps, compared with histologic examination"},{"outcome_type":"secondary","measure":"Diagnostic accuracy of high-definition and magnifying NBI for type 2 and type 3 lesions.","time_frame":"two weeks after endoscopical or surgical resection","description":"For lesions identified as type 2 or type 3, subsequent magnifying NBI examination will be performed by NBI experts. Before that, experts will make their own assessment according to all the images taken by gastroenterological fellows, blind to their diagnosis. Then experts will examine the lesions using magnifying endoscopy with NBI capability and make a new assessment."}]}
{"nct_id":"NCT02745990","start_date":"2016-05-31","phase":"N/A","enrollment":440,"brief_title":"Recombinant Human Erythropoietin Improve Neurodevelopmental Outcomes in Extremely Preterm Infants","primary_completion_date":"2022-12-31","study_type":"Interventional","rec_status":"Enrolling by invitation","completion_date":"2022-12-31","last_update":"2021-08-31","description":"In the ELGAN (Extremely Low Gestational Age Newborn) study, abnormal brain structure and function were associated with intermittent or sustained systemic inflammation (ISSI). Since EPO has anti-inflammatory properties in the kidney and in muscle as well as growth/trophic properties. Based on its potential for neuroprotection, the prospective randomized and masked study was designed to determine whether rhEPO 500u/kg) was also effective in improving developmental outcomes for extremely low gestational age newborns.","other_id":"CZS-EPO","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"All","maximum_age":0.00822,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Preterm infants admitted to NICU wuth gestational age less than 28 weeks\r\n\r\n          -  Age less than 3 days;\r\n\r\n          -  parental informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Major life-threatening anomalies (brain, cardiac, chromosomal anomalies)\r\n\r\n          -  Hematologic crises such as DIC, or hemolysis due to blood group incompatibilities\r\n\r\n          -  Polycythemia (hematocrit > 65);\r\n\r\n          -  Hypertension\r\n\r\n          -  Seizures\r\n\r\n          -  Congenital infection\r\n      ","sponsor":"Huiqing Sun","sponsor_type":"Other","conditions":"Developmental Disabilities","interventions":[{"intervention_type":"Drug","name":"Drug: Recombinant human erythropoietin","description":"rhEPO is administered 500IU/kg, intravenously within 72h after birth, and every other day up to 32 weeks of corrected age."},{"intervention_type":"Drug","name":"Drug: Normal saline","description":"Normal salin is administered the same volume with rhEPO intravenously within 72h after birth, and every other day up to 32 weeks of corrected age.."}],"outcomes":[{"outcome_type":"secondary","measure":"Incidence of deafness","time_frame":"2 years","description":"To compare the incidence of blindness via auditory brainstem response measurements between the two groups at 2 years old"},{"outcome_type":"primary","measure":"Mortality","time_frame":"2 years","description":"To compare the death rate of EPO and control groups at 2 years old"},{"outcome_type":"primary","measure":"Incidence of neurological disability","time_frame":"2 years","description":"To assess the incidence of neurological disability of EPO and control groups at 2 years old"},{"outcome_type":"secondary","measure":"Incidence of MDI<70","time_frame":"2 years","description":"To compare the incidence of MDI<70 via Bayley Scales of Infant Development between the two groups at 2 years old"},{"outcome_type":"secondary","measure":"Incidence of cerebral palsy","time_frame":"2 years","description":"To compare the incidence of cerebral palsy between the two groups at 2 years old"},{"outcome_type":"secondary","measure":"Short-term complicatioins","time_frame":"3 months","description":"Retinopathy of prematurity, periventricular leukomalacia,Intraventricular hemorrhage, necrotising enterocolitis and sepsis"},{"outcome_type":"secondary","measure":"Incidence of blindness","time_frame":"2 years","description":"To compare the incidence of blindness via visual acuity between the two groups at 2 years old"},{"outcome_type":"secondary","measure":"Early blood biomarkers for poor neurological outcomes","time_frame":"4 weeks","description":"To investigate early blood biomarkers via multi-omics to predict poor neurological outcomes"},{"outcome_type":"secondary","measure":"Brain imaging biomarkers for poor neurological outcomes","time_frame":"Up to 40 weeks of corrected age","description":"To investigate Brain imaging biomarkers via MRI to predict poor neurological outcomes"}]}
{"nct_id":"NCT02730065","start_date":"2016-05-31","phase":"N/A","enrollment":110,"brief_title":"Aerobic Dance Training in Small Vessel Disease","official_title":"Effects of Aerobic Dance Training on Cognitive Functions, Mood and Physical Functions in Community Elderly Persons With Cerebral Small Vessel Disease","primary_completion_date":"2019-02-28","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-02-28","last_update":"2018-07-18","description":"Introduction: Cerebral small vessel disease (SVD) is associated with age-related disabilities including dementia, depression, physical and functional impairment. Chinese are more prone to developing SVD than Caucasians. Physical exercise may improve multiple negative consequences associated with SVD. Objective and hypothesis to be tested: To examine the effects of a 24-week structured aerobic dance training on cognition, mood, physical and daily functions in stroke and dementia free older adults with SVD, and whether such effects are mediated through improved cerebral vasomotor reactivity (CVR), a marker of cerebral autoregulation which is impaired in SVD. Design and subjects: Rater-blind RCT comparing the effects of 24-week of structured aerobic dance training upon cognition, mood, physical and daily functions on 110 community dwelling, stroke- and dementia-free persons aged 65 with MRI evidence of significant SVD, defined as the presence of multiple (2) lacunes and/or early confluent or confluent WML. Interventions: Participants are randomized in a 1:1 ratio into a 24-week of structured therapist-led group aerobic dance training with home practice or simple stretching plus health education control group. Main outcome measures: Cognition, mood, physical and daily functions and CVR measured using Transcranial Doppler at baseline, weeks 12, 24 and 36. Data analysis: Intent-to-treat with multiple imputations with treatment efficacy analyzed using mixed effects models. Mediation effects of CVR between aerobic dance training and treatment outcomes tested using mediation models. Expected results: In persons with significant SVD, aerobic dance training improves cognitive, mood, physical and daily functions and such effects are mediated by changes in CVR.","other_id":"03140936","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age 65\r\n\r\n          2. Community dwelling\r\n\r\n          3. Presence of significant SVD, defined by the presence of multiple (2) lacunar infarcts\r\n             and/or a rating of 2 (i.e. beginning confluence of lesions to diffuse involvement of\r\n             lesions in periventricular and/or deep white matter) of WML using the Age-related\r\n             White Matter Changes (ARWMC) Scale on MRI\r\n\r\n          4. Presence of good temporal window on at least one side for TCD evaluation\r\n\r\n          5. Written informed consent given\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. History of stroke\r\n\r\n          2. Dementia, determined by a score on Cantonese MMSE less than education adjusted cutoff\r\n             score for dementia or history of dementia diagnosis\r\n\r\n          3. Comorbidity with medical conditions affecting the central nervous system or cerebral\r\n             white matter\r\n\r\n          4. Inadequately controlled psychiatric disorders affecting cognition and mood\r\n\r\n          5. Physical or sensory impediments hindering participation in cognitive assessment or\r\n             exercise training.\r\n      ","sponsor":"Chinese University of Hong Kong","sponsor_type":"Other","conditions":"Cerebrovascular Disease","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Structured Aerobic Dance Training Group","description":"Systematic physical activity"},{"intervention_type":"Behavioral","name":"Behavioral: Stretching plus education","description":"Weekly group based stretching with psychoeducation and health education"}],"outcomes":[{"outcome_type":"primary","measure":"Daily functioning evaluated by the Lawton's Instrumental Activities of Daily Living","time_frame":"Change from baseline to week 24"},{"outcome_type":"primary","measure":"Cognition assessed by the 30-minute protocol of the National Institute of Neurological Diseases and Stroke - Canadian Stroke Network VCI protocol summary score","time_frame":"Change from baseline to week 24"},{"outcome_type":"primary","measure":"Depressive symptoms evaluated the Geriatric Depression Scale","time_frame":"Change from baseline to week 24"},{"outcome_type":"primary","measure":"Physical balance measured by the Mini-Balance Evaluation Systems Test","time_frame":"Change from baseline to week 24"},{"outcome_type":"primary","measure":"Functional mobility measured by the Timed-up-and-go test","time_frame":"Change from baseline to week 24"},{"outcome_type":"primary","measure":"Walking capacity assessed by the 6-minute walk test","time_frame":"Change from baseline to week 24"},{"outcome_type":"secondary","measure":"Cerebral vasomotor reactivity measured by Pulsatility Index obtained from middle cerebral artery and vertebral artery measured on Transcranial Doppler","time_frame":"Change from baseline to week 24"},{"outcome_type":"secondary","measure":"Cerebral vasomotor reactivity measured by Breath Holding Index obtained from middle cerebral artery and vertebral artery measured on Transcranial Doppler","time_frame":"Change from baseline to week 24"},{"outcome_type":"other","measure":"Number of participants with adverse events or serious adverse events","time_frame":"Throughout the entire study period up to 36 weeks","description":"Adverse events and serious adverse events will be reported to the Chinese University of Hong Kong - New Territories East Cluster Ethics Committee according to standard reporting guidelines"}]}
{"nct_id":"NCT02660892","start_date":"2016-05-26","phase":"N/A","enrollment":6,"brief_title":"Determination of Threonine Requirements in Healthy School-aged Children","official_title":"Determination of Threonine Requirements and the Metabolic Availability of Threonine From Food Sources in Healthy School-aged Children","primary_completion_date":"2017-07-05","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-10-01","last_update":"2020-02-11","description":"Threonine is an indispensable amino acid (nutrient containing nitrogen), which cannot be made in the body and must be consumed from food. Amino acids are the building blocks of protein in your body, and need to be eaten in required amounts to maintain health and growth. Deficiency in threonine can affect small intestine growth due to its structural importance in the intestinal protein mucin. While threonine is found in many foods, deficiency can occur in developing countries where nutrition is primarily plant based, and low in available protein. Therefore, the purpose of this study is to determine the requirement of the indispensable amino acid Threonine, in school-aged children (6-10y). Secondly, we wish to determine the availability of threonine from three test proteins (soy, green pea, casein).","other_id":"H15-02691","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":6,"maximum_age":10,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Children between 6 and 10 Y\r\n\r\n          -  No history of chronic disease or metabolic disorders\r\n\r\n          -  No food allergies\r\n\r\n          -  No recent illness or antibiotic consumption\r\n\r\n          -  Children with a normal, healthy, body weight (between 3rd and 85th percentiles for\r\n             their age group for weight) (Dietitians of Canada, 2015)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Children under 6 years' old\r\n\r\n          -  Children over 10 years' old\r\n\r\n          -  Children with a history of disease or metabolic disorders\r\n\r\n          -  Children with any food allergies\r\n\r\n          -  Children taking prescription medication\r\n\r\n          -  Children with a history of being underweight, overweight, or obese (Dietitians of\r\n             Canada, 2015; Onis et al., 2007)\r\n\r\n             o Below 3rd percentile for weight, Above 85th percentile for weight\r\n\r\n          -  Female children who have commenced menstruation\r\n      ","sponsor":"University of British Columbia","sponsor_type":"Other","conditions":"Threonine Requirements in Children","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Protein intake","description":"Oral consumption of eight hourly experimental meals\r\n4 tracer free experimental meals containing a mixture of free amino acids and calories from protein free flavoured liquid, protein free cookies and corn oil\r\n4 isotopically labeled experimental meals."}],"outcomes":[{"outcome_type":"primary","measure":"13 Co2 production","time_frame":"8 hours (1 study day)","description":"Urine and breath samples will be collected during the study day, to measure the rate of oxidation of tracer phenylalanine in the expired breath, and flux enrichment in urine."}]}
{"nct_id":"NCT02753387","start_date":"2016-05-23","phase":"Phase 3","enrollment":80,"brief_title":"Effect of Oral Preparation on Bacterial Colonization of the Pharyngeal Mucosa in Surgery of Head and Neck Cancer","official_title":"Effect of Oral Preparation on Bacterial Colonization of the Pharyngeal Mucosa in Surgery of Head and Neck Cancer","primary_completion_date":"2018-09-05","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-09-05","last_update":"2018-12-20","description":"Surgical site infections are an important health indicator for hospitals and a significant medico-economic issue. The aim of the study is to assess the impact of chlorhexidine mouthwash performed before surgery on the bacterial colonization of the pharyngeal mucosa.","other_id":"35RC15_8923_ORAL-ISO","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histological evidence of cancer regardless of histological type\r\n\r\n          -  Surgical treatment requiring mucosal effraction regardless of the surgical approach;\r\n\r\n          -  Patient over 18 years old;\r\n\r\n          -  Oral cancer, oropharyngeal cancer, hypopharyngeal cancer or laryngeal cancer;\r\n\r\n          -  Written and informed patient consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Concomitant Vascular Interventions;\r\n\r\n          -  Interventional radiology;\r\n\r\n          -  Needing of second surgery at a same location during the 30 postoperative days);\r\n\r\n          -  Cancer of the paranasal sinus, nasal cavity, skull base, salivary glands, skin,\r\n\r\n          -  Neck dissection without mucosal effraction\r\n\r\n          -  Thyroid or parathyroid surgery\r\n\r\n          -  Size tumor forbidden tumor surgery\r\n\r\n          -  Allergy to any tested product;\r\n\r\n          -  Concurrent infection the day before or day of surgery\r\n\r\n          -  Protected adults (guardianship) and persons deprived of liberty\r\n      ","sponsor":"Rennes University Hospital","sponsor_type":"Other","conditions":"Bacterial Infection","interventions":[{"intervention_type":"Drug","name":"Drug: Chlorhexidine","description":"4 mouthwashes during 30 seconds with Eludril Perio 10 ml and 1 application after intubation with Eludril Perio"},{"intervention_type":"Device","name":"Device: NaCl 0.9 %","description":"4 mouthwashes during 30 seconds with NaCl 0.9 % 10 ml and 1 application after intubation with NaCl 0.9 %"}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of patients with pharyngeal mucosa colonization (>=10^2 Colony Forming Unit (CFU)/ml of pathogen germs of the oral flora) at the end of the surgery","time_frame":"The day of the surgery","description":"The percentage of patients with pharyngeal mucosa colonization will be determined from the sample collected on the mucosal scar just before the end of the surgery (T5)"},{"outcome_type":"secondary","measure":"Number of patients with a significant rate of pathogen germs (>=10^2 CFU/ml) at T1","time_frame":"The day of the surgery","description":"The number of patients with a significant rate of pathogen germs will be determined from the sample collected after mouthwash (T1)"},{"outcome_type":"secondary","measure":"Type of oral germs","time_frame":"The day of the surgery","description":"The type of germs will be determined for all the samples collected during the surgery (i.e. before mouthwash (T0), after mouthwash (T1), before intubation in the operating room (T2), after intubation (T3), before incision (T4) and just before the end of the intervention on the mucosal scar (T5))"},{"outcome_type":"secondary","measure":"Number of positive cultures of pathogen germs","time_frame":"The day of the surgery","description":"The number of positive cultures of pathogen germs will be determined for all the samples collected during the surgery (i.e. before mouthwash (T0), after mouthwash (T1), before intubation in the operating room (T2), after intubation (T3), before incision (T4) and just before the end of the intervention on the mucosal scar (T5))"},{"outcome_type":"secondary","measure":"Kinetics of the number of CFU/ml","time_frame":"The day of the surgery","description":"The kinetics of the number of CFU/ml will be determined from all the samples collected during the surgery (i.e. before mouthwash (T0), after mouthwash (T1), before intubation in the operating room (T2), after intubation (T3), before incision (T4) and just before the end of the intervention on the mucosal scar (T5))"},{"outcome_type":"secondary","measure":"Number of CFU/ml of pathogens germs","time_frame":"The day of the surgery","description":"The number of CFU/ml of pathogens germs will be determined for all the samples collected during the surgery (i.e. before mouthwash (T0), after mouthwash (T1), before intubation in the operating room (T2), after intubation (T3), before incision (T4) and just before the end of the intervention on the mucosal scar (T5))"},{"outcome_type":"secondary","measure":"Surgical site infections rate in the postoperative month (standard definition of the Centers for Disease Control and Prevention, Atlanta)","time_frame":"30 days"},{"outcome_type":"secondary","measure":"Number of patients who processed correctly preoperative mouthwash","time_frame":"The day of the surgery"},{"outcome_type":"secondary","measure":"Change in the number of CFU/ml of pathogen germs before and after intubation (T2-T3)","time_frame":"The day of the surgery","description":"The change in the number of CFU/ml of pathogen germs will be assessed using the samples collected before (T2) and after intubation (T3)"}]}
{"nct_id":"NCT02475655","start_date":"2016-05-16","phase":"Phase 2","enrollment":60,"brief_title":"Evaluating the Safety and Tolerability of Ruxolitinib in Antiretroviral-Treated HIV-Infected Adults","official_title":"A Randomized, Pilot Study of Ruxolitinib in Antiretroviral-Treated HIV-Infected Adults","primary_completion_date":"2018-02-18","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-04-04","last_update":"2020-08-17","description":"The purpose of this study was to evaluate the safety and tolerability of ruxolitinib in HIV-positive adults who were virologically suppressed and who were on antiretroviral therapy (ART).","other_id":"A5336","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  HIV-1 infection\r\n\r\n          -  CD4+ T cell count greater than 350 cells/mm^3 within 45 days prior to study entry\r\n\r\n          -  Documented virologic suppression defined as HIV-1 RNA level below the limit of\r\n             quantification (eg, less than 40, less than 50, or less than 75 copies/mL, depending\r\n             on the assay) using an FDA-approved assay with a quantification limit of 75 copies/mL\r\n             or lower for at least 48 weeks prior to study entry\r\n\r\n          -  Screening HIV-1 RNA level below the limit of quantification\r\n\r\n          -  Tuberculosis (TB) screening within 365 days of the screening visit diagnosed by\r\n             tuberculin skin test or interferon gamma release assay\r\n\r\n          -  Currently on continuous ART for at least 730 days prior to study entry, defined as\r\n             continuous ART for the 730 days period, inclusive, prior to study entry with no ART\r\n             interruption longer than 7 consecutive days. NOTE: The current regimen must include\r\n             TDF/FTC, TAF/FTC, TDF+3TC, or ABC/3TC; plus a nonnucleoside reverse transcriptase\r\n             inhibitor or integrase strand transfer inhibitor (NNRTI or INSTI, not containing\r\n             cobicistat) for at least 60 days, inclusive, prior to study entry.\r\n\r\n          -  The following laboratory values obtained within 45 days prior to entry:\r\n\r\n               -  Absolute neutrophil count (ANC) greater than or equal to 1,000/mm^3\r\n\r\n               -  Hemoglobin greater than 12.0 g/dL for men and greater than 11.0 g/dL for women\r\n\r\n               -  Platelets greater than or equal to 140,000/mm^3\r\n\r\n               -  Calculated creatinine clearance (CrCl) greater than or equal to 70 mL/min (by\r\n                  Cockcroft Gault equation)\r\n\r\n               -  Aspartate aminotransferase (AST) (SGOT) less than or equal to 1.5x upper limit of\r\n                  normal (ULN)\r\n\r\n               -  Alanine aminotransferase (ALT) (SGPT) less than or equal to 1.5x ULN\r\n\r\n               -  Alkaline phosphatase less than or equal to 1.5x ULN\r\n\r\n          -  For females of reproductive potential, a negative serum or urine pregnancy test with a\r\n             sensitivity of 25 mIU/mL within 72 hours, inclusive, prior to study entry\r\n\r\n          -  All participants must agree not to participate in a conception process (e.g., active\r\n             attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization)\r\n\r\n          -  All participants of reproductive potential, who were participating in sexual activity\r\n             that could lead to pregnancy, must agree to use at least one reliable method of\r\n             contraception while receiving the study drugs and for 7 weeks after stopping the\r\n             medications\r\n\r\n          -  Ability and willingness of participant or legal representative to provide written\r\n             informed consent and attend study visits as scheduled at a participating site\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  A current or past history of progressive multifocal leukoencephalopathy\r\n\r\n          -  Breastfeeding or pregnancy\r\n\r\n          -  Use of strong inhibitors or inducers of CYP3A4 including a protease inhibitor,\r\n             cobicistat or entry inhibitors as part of the current ART regimen or other concomitant\r\n             therapy\r\n\r\n          -  Known allergy/sensitivity or any hypersensitivity to components of study drug or their\r\n             formulation\r\n\r\n          -  Active drug or alcohol use or dependence that, in the opinion of the site\r\n             investigator, would interfere with adherence to study requirements\r\n\r\n          -  Acute or serious illness or infection requiring systemic treatment and/or\r\n             hospitalization within 60 days prior to entry\r\n\r\n          -  Vaccinations (other than influenza) less than or equal to 45 days prior to the study\r\n             entry visit.\r\n\r\n          -  Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), systemic\r\n             cytotoxic chemotherapy or investigational therapy less than or equal to 60 days prior\r\n             to study entry\r\n\r\n          -  Any current diagnosis or past history of a significant cardiovascular, respiratory,\r\n             hepatic, gastrointestinal, endocrine, hematological, neurological, neuropsychiatric,\r\n             psychiatric, or other serious illness that, in the opinion of the investigator, could\r\n             constitute a risk when taking investigational product or could interfere with the\r\n             interpretation of data or affect the participant's ability to participate in the\r\n             study. Diagnoses that would lead to exclusion include, but were not limited to the\r\n             following:\r\n\r\n               -  CDC category C AIDS-indicator conditions\r\n\r\n               -  NOTE A: Except HIV encephalopathy, HIV wasting, esophageal candidiasis, or\r\n                  pneumocystis pneumonia without dissemination.\r\n\r\n               -  NOTE B: List available: http://www.cdc.gov/mmwr/preview/mmwrhtml/00018871.htm\r\n\r\n               -  Herpes zoster (dermatomal or non-dermatomal).\r\n\r\n               -  NOTE C: A history of prior chickenpox was not exclusionary.\r\n\r\n               -  Lymphoproliferative malignancy\r\n\r\n               -  Chronic liver disease of any etiology and any degree of severity\r\n\r\n               -  Chronic hepatitis, except for hepatitis C that has been cured (defined as a\r\n                  Sustained Virologic Response, which is an undetectable HCV-RNA at 12 weeks or\r\n                  more after completing treatment measured by a sensitive, qualitative, or\r\n                  quantitative HCV-RNA assay)\r\n\r\n               -  Disseminated fungal infection of any type or duration that is not limited to\r\n                  cutaneous or mucocutaneous surfaces\r\n\r\n               -  A medical disorder that predisposes to bleeding\r\n\r\n          -  Change in the ART regimen within 12 weeks, inclusive, prior to study entry or intended\r\n             modification of ART during the study.\r\n\r\n          -  History of untreated latent tuberculosis infection (LTBI) diagnosed by tuberculin skin\r\n             test or interferon gamma release assay. LTBI treatment would consist of 9 months of\r\n             isoniazid or an equivalent therapy completed at least 4 weeks prior to study entry.\r\n      ","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","sponsor_type":"NIH","conditions":"HIV Infections","interventions":[{"intervention_type":"Drug","name":"Drug: Ruxolitinib","description":"10 mg orally twice daily for 5 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of Participants on the Ruxolitinib Arm Who Experienced Any Safety Milestone Events While On-Treatment","time_frame":"Entry to Week 5","description":"Events defined as safety milestones are listed below and together makeup the composite endpoint.\r\nConfirmed CD4+ decline > 33% of entry and to < 350 cell/mm^3 (for participants with entry CD4+ T cell count < 700 cells/mm^3)\r\nConfirmed CD4+ decline > 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm^3)\r\nConfirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART\r\nNew or recurrent CDC category C AIDS-indicator condition\r\nHIV-1 associated infection including Herpes zoster\r\nLymphoproliferative malignancies\r\nGrade 4 or recurrence of Grade 3 anemia/neutropenia\r\nNew diagnosis of pneumonia, sepsis, or bacteremia\r\nDiscontinuation of Ruxolitinib due to thrombocytopenia\r\nAny Grade 4 or recurrence of Grade 3 toxicity related to study drug\r\nPercent experiencing a safety milestone will be reported."},{"outcome_type":"primary","measure":"Percentage of Participants Who Experienced Any Safety Milestones On-study From Entry to Week 5","time_frame":"Entry to Week 5","description":"Events defined as safety milestones are listed below and together makeup the composite endpoint.\r\nConfirmed CD4+ decline > 33% of entry and to < 350 cell/mm^3 (for participants with entry CD4+ T cell count < 700 cells/mm^3)\r\nConfirmed CD4+ decline > 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm^3)\r\nConfirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART\r\nNew or recurrent CDC category C AIDS-indicator condition\r\nHIV-1 associated infection including Herpes zoster\r\nLymphoproliferative malignancies\r\nGrade 4 or recurrence of Grade 3 anemia/neutropenia\r\nNew diagnosis of pneumonia, sepsis, or bacteremia\r\nOccurrence of Grade 2 or higher thrombocytopenia\r\nAny Grade 4 or recurrence of Grade 3 toxicity\r\nPercent experiencing a safety milestone will be reported."},{"outcome_type":"primary","measure":"Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 5","time_frame":"Entry to Week 5","description":"Events defined as safety milestones are listed below.\r\nConfirmed CD4+ decline > 33% of entry and to < 350 cell/mm^3 (for participants with entry CD4+ T cell count < 700 cells/mm^3)\r\nConfirmed CD4+ decline > 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm^3)\r\nConfirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART\r\nNew or recurrent CDC category C AIDS-indicator condition\r\nHIV-1 associated infection including Herpes zoster\r\nLymphoproliferative malignancies\r\nGrade 4 or recurrence of Grade 3 anemia/neutropenia\r\nNew diagnosis of pneumonia, sepsis, or bacteremia\r\nOccurrence of Grade 2 or higher thrombocytopenia\r\nAny Grade 4 or recurrence of Grade 3 toxicity\r\nPercent experiencing each safety milestone will be reported. Safety milestone categories are not mutually exclusive."},{"outcome_type":"primary","measure":"Number of Participants With Premature Discontinuation of Study Treatment in the Ruxolitinib Arm","time_frame":"Entry to Week 5","description":"Number of participants with premature discontinuation of study treatment are summarized."},{"outcome_type":"primary","measure":"Fold Change in the Level of Plasma Interleukin 6 (IL-6) From Baseline to Week 4/5","time_frame":"Pre-entry, Entry, Weeks 4 and 5","description":"All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.\r\nBaseline is defined as the geometric mean of the Pre-entry and Entry values. Week 4/5 is defined as the geometric mean of the Week 4 and Week 5 values. Fold change was calculated as the value at Week 4/5 divided by the value at Baseline."},{"outcome_type":"secondary","measure":"Percentage of Participants on the Ruxolitinib Arm Who Experienced Any Safety Milestone Events During Total Follow-up","time_frame":"Entry to Week 12","description":"Events defined as safety milestones are listed below and together makeup the composite endpoint.\r\nConfirmed CD4+ decline > 33% of entry and to < 350 cell/mm^3 (for participants with entry CD4+ T cell count < 700 cells/mm^3)\r\nConfirmed CD4+ decline > 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm^3)\r\nConfirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART\r\nNew or recurrent CDC category C AIDS-indicator condition\r\nHIV-1 associated infection including Herpes zoster\r\nLymphoproliferative malignancies\r\nGrade 4 or recurrence of Grade 3 anemia/neutropenia\r\nNew diagnosis of pneumonia, sepsis, or bacteremia\r\nDiscontinuation of Ruxolitinib due to thrombocytopenia\r\nAny Grade 4 or recurrence of Grade 3 toxicity related to study drug\r\nPercent experiencing a safety milestone will be reported."},{"outcome_type":"secondary","measure":"Percentage of Participants Who Experienced Any Safety Milestones On-study From Entry to Week 12","time_frame":"Entry to Week 12","description":"Events defined as safety milestones are listed below and together makeup the composite endpoint.\r\nConfirmed CD4+ decline > 33% of entry and to < 350 cell/mm^3 (for participants with entry CD4+ T cell count < 700 cells/mm^3)\r\nConfirmed CD4+ decline > 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm^3)\r\nConfirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART\r\nNew or recurrent CDC category C AIDS-indicator condition\r\nHIV-1 associated infection including Herpes zoster\r\nLymphoproliferative malignancies\r\nGrade 4 or recurrence of Grade 3 anemia/neutropenia\r\nNew diagnosis of pneumonia, sepsis, or bacteremia\r\nOccurrence of Grade 2 or higher thrombocytopenia\r\nAny Grade 4 or recurrence of Grade 3 toxicity\r\nPercent experiencing a safety milestone will be reported."},{"outcome_type":"secondary","measure":"Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 12","time_frame":"Entry to Week 12","description":"Events defined as safety milestones are listed below.\r\nConfirmed CD4+ decline > 33% of entry and to < 350 cell/mm3 (for participants with entry CD4+ T cell count < 700 cells/mm3)\r\nConfirmed CD4+ decline > 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm3)\r\nConfirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART\r\nNew or recurrent CDC category C AIDS-indicator condition\r\nHIV-1 associated infection including Herpes zoster\r\nLymphoproliferative malignancies\r\nGrade 4 or recurrence of Grade 3 anemia/neutropenia\r\nNew diagnosis of pneumonia, sepsis, or bacteremia\r\nOccurrence of Grade 2 or higher thrombocytopenia\r\nAny Grade 4 or recurrence of Grade 3 toxicity\r\nPercent experiencing each safety milestone will be reported. Safety milestone categories are not mutually exclusive."},{"outcome_type":"secondary","measure":"Number of Participants Who Experienced a Protocol-defined Reportable Adverse Event at Any Post-entry Time Point.","time_frame":"Entry to Week 12","description":"Protocol-defined reportable adverse events include: all diagnoses regardless of grade, Grade 3 or higher sign/symptoms or laboratory values, any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. See the Protocol Section References for links to the EAE manual.\r\nThis is a subset of the events reported in the Adverse Events section."},{"outcome_type":"secondary","measure":"Creatinine Clearance","time_frame":"Entry, Weeks 1, 2, 4, 5, 10, and 12","description":"Creatinine clearance was calculated using the Cockcroft Gault equation. The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined."},{"outcome_type":"secondary","measure":"Change in Creatinine Clearance Values From Entry","time_frame":"Entry, Weeks 1, 2, 4, 5, 10, and 12","description":"Creatinine clearance was calculated using the Cockcroft Gault equation. The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.\r\nAbsolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry."},{"outcome_type":"secondary","measure":"Creatinine","time_frame":"Entry, Weeks 1, 2, 4, 5, 10, and 12","description":"The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined."},{"outcome_type":"secondary","measure":"Change in Creatinine Values From Entry","time_frame":"Entry, Weeks 1, 2, 4, 5, 10, and 12","description":"The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.\r\nAbsolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry."},{"outcome_type":"secondary","measure":"Absolute Neutrophil Count (ANC)","time_frame":"Entry, Weeks 1, 2, 4, 5, 10, and 12","description":"The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined."},{"outcome_type":"secondary","measure":"Change in Absolute Neutrophil Count (ANC) Values From Entry","time_frame":"Entry, Weeks 1, 2, 4, 5, 10, and 12","description":"The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.\r\nAbsolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry."},{"outcome_type":"secondary","measure":"Hemoglobin","time_frame":"Entry, Weeks 1, 2, 4, 5, 10, and 12","description":"The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined."},{"outcome_type":"secondary","measure":"Change in Hemoglobin Values From Entry","time_frame":"Entry, Weeks 1, 2, 4, 5, 10, and 12","description":"The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.\r\nAbsolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry."},{"outcome_type":"secondary","measure":"Platelet Count","time_frame":"Entry, Weeks 1, 2, 4, 5, 10, and 12","description":"The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined."},{"outcome_type":"secondary","measure":"Change in Platelet Counts From Entry","time_frame":"Entry, Weeks 1, 2, 4, 5, 10, and 12","description":"The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.\r\nAbsolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry."},{"outcome_type":"secondary","measure":"Aspartate Aminotransferase (AST) (SGOT)","time_frame":"Entry, Weeks 1, 2, 4, 5, 10, and 12","description":"The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined."},{"outcome_type":"secondary","measure":"Change in Aspartate Aminotransferase (AST) (SGOT) Values From Entry","time_frame":"Entry, Weeks 1, 2, 4, 5, 10, and 12","description":"The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.\r\nAbsolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry."},{"outcome_type":"secondary","measure":"Alanine Aminotransferase (ALT) (SGPT)","time_frame":"Entry, Weeks 1, 2, 4, 5, 10, and 12","description":"The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined."},{"outcome_type":"secondary","measure":"Change in Alanine Aminotransferase (ALT) (SGPT) Values From Entry","time_frame":"Entry, Weeks 1, 2, 4, 5, 10, and 12","description":"The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.\r\nAbsolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry."},{"outcome_type":"secondary","measure":"Fold Change in the Level of Plasma Interleukin 6 (IL-6)","time_frame":"Pre-entry, Entry, Weeks 4, 5, 10 and 12","description":"All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.\r\nBaseline is defined as the geometric mean of the Pre-entry and Entry values. Week 4/5 is defined as the geometric mean of the Week 4 and Week 5 values. Week 10/12 is defined as the geometric mean of the Week 10 and Week 12 values. Fold change was calculated as the value at Week 10/12 divided by the value at Baseline and the value at Week 4/5 divided by the value at Week 10/12."},{"outcome_type":"secondary","measure":"Change in (CD3+CD8+) CD25+","time_frame":"Entry, Weeks 5 and 12","description":"Absolute change in the percent of parent cells (CD8+) that express CD25+ cells (cellular marker of immune activation and inflammation in the peripheral blood).\r\nAbsolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry."},{"outcome_type":"secondary","measure":"Fold Change in the Level of Soluble CD14 (sCD14)","time_frame":"Pre-entry, Entry, Weeks 4, 5, and 12","description":"All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.\r\nBaseline is defined as the geometric mean of the Pre-entry and Entry values. Week 4/5 is defined as the geometric mean of the Week 4 and Week 5 values. Fold change was calculated as the value at Week 4/5 divided by the value at Baseline, the value at Week 12 divided by the value at Baseline, and the value at Week 12 divided by the value at Week 4/5."},{"outcome_type":"secondary","measure":"Change in CD4+ T Cell Count","time_frame":"Pre-entry, Entry, Weeks 2, 5, and 12","description":"Baseline is defined as the average of pre-entry and entry. Absolute change was calculated as the value at Week 2 minus the value at Baseline, the value at week 5 minus the value at baseline, the value at week 12 minus the value at baseline, and the value at week 5 minus the value at week 12."},{"outcome_type":"secondary","measure":"Number of Participants With Plasma HIV-1 RNA Level Above the Limit of Quantification","time_frame":"Entry, Weeks 2, 5, and 12","description":"Participants were required to be virally suppressed, with a plasma HIV-1 RNA level below 40 copies/mL. The number of participants with plasma HIV-1 RNA level above the limit of quantification is reported at each time point."},{"outcome_type":"secondary","measure":"Relative Risks of HIV-1 RNA by Single Copy Assay (SCA) < 0.4 Copies/mL","time_frame":"Entry, Weeks 5 and 12","description":"HIV-1 RNA was measured via Single Copy Assay Using Primer in Integrase (iSCA), results were reported as below or above the assay limit of detection (LOD) (LOD = 0.4 copies/mL). GEE models for binary data were used to calculate the relative risk of having HIV-1 RNA by iSCA <0.4 copies/mL (Week 5 compared to Entry, Week 12 compared to Entry, and Week 12 compared to Week 5)."},{"outcome_type":"secondary","measure":"Fold Change in the Level of Plasma Tumor Necrosis Factor Alpha (TNF Alpha)","time_frame":"Entry, Weeks 5 and 12","description":"All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.\r\nFold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry."},{"outcome_type":"secondary","measure":"Fold Change in the Level of Plasma Interleukin 1 Beta (IL-1 Beta)","time_frame":"Entry, Weeks 5 and 12","description":"All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.\r\nFold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry."},{"outcome_type":"secondary","measure":"Fold Change in the Level of Plasma Interleukin 7 (IL-7)","time_frame":"Entry, Weeks 5 and 12","description":"All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.\r\nFold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry."},{"outcome_type":"secondary","measure":"Fold Change in the Level of Interleukin 1 Alpha (IL-1 Alpha)","time_frame":"Pre-entry, Entry, Weeks 4, 5, and 12","description":"Laboratory testing was not performed so the data are not available."},{"outcome_type":"secondary","measure":"Fold Change in the Level of Interferon Gamma-induced Protein 10 (IP-10)","time_frame":"Pre-entry, Entry, Weeks 4, 5, and 12","description":"Laboratory testing was not performed so the data are not available."},{"outcome_type":"secondary","measure":"Fold Change in the Level of Macrophage Colony-stimulating Factor","time_frame":"Pre-entry, Entry, Weeks 4, 5, and 12","description":"Laboratory testing was not performed so the data are not available."},{"outcome_type":"secondary","measure":"Fold Change in the Level of Neopterin","time_frame":"Pre-entry, Entry, Weeks 4, 5, and 12","description":"Data not available because the testing lab reported that the values were unreliable."},{"outcome_type":"secondary","measure":"Fold Change in the Level of Plasma Interleukin 10 (IL-10)","time_frame":"Entry, Weeks 5 and 12","description":"All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.\r\nFold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry."},{"outcome_type":"secondary","measure":"Fold Change in the Level of Plasma Interleukin 15 (IL-15)","time_frame":"Entry, Weeks 5 and 12","description":"All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.\r\nFold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry."},{"outcome_type":"secondary","measure":"Fold Change in the Level of Plasma Interleukin 18 (IL-18)","time_frame":"Entry, Weeks 5 and 12","description":"All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.\r\nFold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry."},{"outcome_type":"secondary","measure":"Fold Change in the Level of Plasma Transforming Growth Factor Beta 1 (TGF Beta-1)","time_frame":"Entry, Weeks 5 and 12","description":"All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.\r\nFold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry."},{"outcome_type":"secondary","measure":"Fold Change in the Level of Plasma Transforming Growth Factor Beta 2 (TGF Beta-2)","time_frame":"Entry, Weeks 5 and 12","description":"All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.\r\nFold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry."},{"outcome_type":"secondary","measure":"Fold Change in the Level of Plasma Transforming Growth Factor Beta 3 (TGF Beta-3)","time_frame":"Entry, Weeks 5 and 12","description":"All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.\r\nFold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry."},{"outcome_type":"secondary","measure":"Change in (CD3+CD4+) CD38+HLADR+","time_frame":"Entry, Weeks 5 and 12","description":"Absolute change in the percent of parent cells (CD4+) that express CD38+HLADR+ cells (cellular marker of immune activation and inflammation in the peripheral blood).\r\nAbsolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry."},{"outcome_type":"secondary","measure":"Change in (CD3+CD8+) CD38+HLADR+","time_frame":"Entry, Weeks 5 and 12","description":"Absolute change in the percent of parent cells (CD8+) that express CD38+HLADR+ cells (cellular marker of immune activation and inflammation in the peripheral blood).\r\nAbsolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry."},{"outcome_type":"secondary","measure":"Change in (CD3+CD4+) CD25hi+","time_frame":"Entry, Weeks 5 and 12","description":"Absolute change in the percent of parent cells (CD4+) that express CD25hi+ cells (cellular marker of immune activation and inflammation in the peripheral blood).\r\nAbsolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry."},{"outcome_type":"secondary","measure":"Change in (CD3+CD4+) CD127+","time_frame":"Entry, Weeks 5 and 12","description":"Absolute change in the percent of parent cells (CD4+) that express CD127+ cells (cellular marker of immune activation and inflammation in the peripheral blood).\r\nAbsolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry."},{"outcome_type":"secondary","measure":"Change in (CD3+CD8+) CD127+","time_frame":"Entry, Weeks 5 and 12","description":"Absolute change in the percent of parent cells (CD8+) that express CD127+ cells (cellular marker of immune activation and inflammation in the peripheral blood).\r\nAbsolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry."},{"outcome_type":"secondary","measure":"Change in (CD3+CD4+) Ki67+","time_frame":"Entry, Weeks 5 and 12","description":"Absolute change in the percent of parent cells (CD4+) that express Ki67+ cells (cellular marker of immune activation and inflammation in the peripheral blood).\r\nAbsolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry."},{"outcome_type":"secondary","measure":"Change in (CD3+CD8+) Ki67+","time_frame":"Entry, Weeks 5 and 12","description":"Absolute change in the percent of parent cells (CD8+) that express Ki67+ cells (cellular marker of immune activation and inflammation in the peripheral blood).\r\nAbsolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry."},{"outcome_type":"secondary","measure":"Change in (CD3+CD4+) Bcl2+","time_frame":"Entry, Weeks 5 and 12","description":"Absolute change in the percent of parent cells (CD4+) that express Bcl2+ cells (cellular marker of immune activation and inflammation in the peripheral blood).\r\nAbsolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry."},{"outcome_type":"secondary","measure":"Change in (CD3+CD8+) Bcl2+","time_frame":"Entry, Weeks 5 and 12","description":"Absolute change in the percent of parent cells (CD8+) that express Bcl2+ cells (cellular marker of immune activation and inflammation in the peripheral blood).\r\nAbsolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry."},{"outcome_type":"secondary","measure":"Change in (CD3+CD4+) a4b7+","time_frame":"Entry, Weeks 5 and 12","description":"Absolute change in the percent of parent cells (CD4+) that express a4b7+ cells (cellular marker of immune activation and inflammation in the peripheral blood).\r\nAbsolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry."},{"outcome_type":"secondary","measure":"Change in (CD3+CD8+) a4b7+","time_frame":"Entry, Weeks 5 and 12","description":"Absolute change in the percent of parent cells (CD8+) that express a4b7+ cells (cellular marker of immune activation and inflammation in the peripheral blood).\r\nAbsolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry."},{"outcome_type":"secondary","measure":"Change in (CD3+CD4+) CX3CR1+","time_frame":"Entry, Weeks 5 and 12","description":"Absolute change in the percent of parent cells (CD4+) that express CX3CR1+ cells (cellular marker of immune activation and inflammation in the peripheral blood).\r\nAbsolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry."},{"outcome_type":"secondary","measure":"Change in (CD3+CD8+) CX3CR1+","time_frame":"Entry, Weeks 5 and 12","description":"Absolute change in the percent of parent cells (CD8+) that express CX3CR1+ cells (cellular marker of immune activation and inflammation in the peripheral blood).\r\nAbsolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry."},{"outcome_type":"secondary","measure":"Change in CD69","time_frame":"Entry, Weeks 5 and 12","description":"Data not available because the team decided they were no longer clinically relevant, so samples were not tested for CD69."},{"outcome_type":"secondary","measure":"Change in PAR-1","time_frame":"Entry, Weeks 5 and 12","description":"Data not available because the team decided they were no longer clinically relevant, so samples were not tested for PAR-1."},{"outcome_type":"secondary","measure":"Change in Classical Monocytes (CD14+CD16-)","time_frame":"Entry, Weeks 5 and 12","description":"Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry."},{"outcome_type":"secondary","measure":"Change in Classical Monocytes (CD14+CD16-) Expressing CD163+","time_frame":"Entry, Weeks 5 and 12","description":"Absolute change in the percent of classical monocytes (CD14+CD16-) that express CD163+.\r\nAbsolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry."},{"outcome_type":"secondary","measure":"Change in Classical Monocytes (CD14+CD16-) Expressing CCR2+","time_frame":"Entry, Weeks 5 and 12","description":"Absolute change in the percent of classical monocytes (CD14+CD16-) that express CCR2+.\r\nAbsolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry."},{"outcome_type":"secondary","measure":"Change in Classical Monocytes (CD14+CD16-) Expressing CX3CR1+","time_frame":"Entry, Weeks 5 and 12","description":"Absolute change in the percent of classical monocytes (CD14+CD16-) that express CX3CR1+.\r\nAbsolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry."},{"outcome_type":"secondary","measure":"Change in Inflammatory Monocytes (CD14+CD16+)","time_frame":"Entry, Weeks 5 and 12","description":"Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry."},{"outcome_type":"secondary","measure":"Change in Inflammatory Monocytes (CD14+CD16+) Expressing CD163+","time_frame":"Entry, Weeks 5 and 12","description":"Absolute change in the percent of inflammatory monocytes (CD14+CD16-) that express CD163+.\r\nAbsolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry."},{"outcome_type":"secondary","measure":"Change in Inflammatory Monocytes (CD14+CD16+) Expressing CCR2+","time_frame":"Entry, Weeks 5 and 12","description":"Absolute change in the percent of inflammatory monocytes (CD14+CD16+) that express CCR2+.\r\nAbsolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry."},{"outcome_type":"secondary","measure":"Change in Inflammatory Monocytes (CD14+CD16+) Expressing CX3CR1+","time_frame":"Entry, Weeks 5 and 12","description":"Absolute change in the percent of inflammatory monocytes (CD14+CD16+) that express CX3CR1+.\r\nAbsolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry."},{"outcome_type":"secondary","measure":"Change in Patrolling Monocytes (CD14dimCD16+)","time_frame":"Entry, Weeks 5 and 12","description":"Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry."},{"outcome_type":"secondary","measure":"Change in Patrolling Monocytes (CD14dimCD16+) Expressing CD163+","time_frame":"Entry, Weeks 5 and 12","description":"Absolute change in the percent of patrolling monocytes (CD14dimCD16+) that express CD163+.\r\nAbsolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry."},{"outcome_type":"secondary","measure":"Change in Patrolling Monocytes (CD14dimCD16+) Expressing CCR2+","time_frame":"Entry, Weeks 5 and 12","description":"Absolute change in the percent of patrolling monocytes (CD14dimCD16+) that express CCR2+.\r\nAbsolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry."},{"outcome_type":"secondary","measure":"Change in Patrolling Monocytes (CD14dimCD16+) Expressing CX3CR1+","time_frame":"Entry, Weeks 5 and 12","description":"Absolute change in the percent of patrolling monocytes (CD14dimCD16+) that express CX3CR1+.\r\nAbsolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry."},{"outcome_type":"secondary","measure":"Fold Change in Cellular HIV-1 DNA","time_frame":"Entry, Weeks 5 and 12","description":"All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.\r\nFold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry."},{"outcome_type":"secondary","measure":"Fold Change in Cellular HIV-1 Total RNA","time_frame":"Entry, Weeks 5 and 12","description":"All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.\r\nFold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry."},{"outcome_type":"secondary","measure":"Percentage of Participants With Detectable CMV Shedding","time_frame":"Pre-entry, Entry, and Weeks 1, 2, 4, 5, 10, and 12","description":"Level of CMV shedding was summarized by study week and arm as the percentage of those above and below the assay limit of detection.\r\nDetectable CMV shedding was defined as CMV level > 0 copies/ml of elution. The percentage of participants with detectable CMV at any on-treatment time point (ever shedding at weeks 1, 2, 4, or 5) and any post-treatment time point (ever shedding at weeks 10 or 12) was contrasted between study arms."},{"outcome_type":"secondary","measure":"Ruxolitinib Systemic Clearance (CL/F) From 2-compartment Pharmacokinetic (PK)","time_frame":"Week 1 and, Week 4/5; blood samples were drawn pre-dose and at 1-1.5, 2.5-4, 4-6, and 6-8 hours post-dosing","description":"Ruxolitinib plasma concentrations were fitted to a population 2-compartment distribution model, assuming first-order input, distribution and elimination from the plasma compartment, using nonlinear mixed-effects modeling software. We estimated parameter geometric means and proportional variabilities between subjects (IIV when feasible) and the variability in drug absorption between occasions (IOV week 1 and week 4/5), and related distribution volumes to body weight."},{"outcome_type":"other","measure":"Change in 2 Long-terminal Repeat Sequences [LTRs]","time_frame":"Entry, Week 5, and Week 12","description":"Data not available because all values were below assay limit."},{"outcome_type":"other","measure":"Level of HHV Shedding (EBV, HSV, HHV-6, HHV-7, and HHV-8)","time_frame":"Pre-entry, Entry, Weeks 1, 2, 4, 5, 10, and 12","description":"Data not available because no samples were collected to test for these measures as the team decided they were no longer clinically relevant."},{"outcome_type":"other","measure":"Fold Change in Integrated DNA","time_frame":"Entry, Weeks 5 and 12","description":"All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.\r\nFold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry."}]}
{"nct_id":"NCT02752061","start_date":"2016-05-13","phase":"N/A","enrollment":979,"brief_title":"Potlako: A Programmatic Intervention to Improve Access to Timely Oncology Care","official_title":"Potlako: A Programmatic Multi-facility Level Intervention to Improve Access to Timely Oncology Care in Botswana","primary_completion_date":"2020-07-21","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-07-21","last_update":"2020-07-23","description":"Diagnostic and treatment delays contribute substantially to disparities in cancer morbidity and mortality between low- and middle- income countries (LMICs) and high-income countries. Individuals present with advanced stage disease resulting in minimal chance for cure or long-term survival. The Potlako project will implement and evaluate a multifaceted intervention to test the hypothesis that a package of enhanced coordination of care including an electronic messaging, transportation support, and training targeted at generalist clinicians at primary and secondary level facilities, can reduce time to diagnosis and stage at diagnosis for HIV-infected individuals with cancer.","other_id":"BHP078","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Citizen of Botswana\r\n\r\n          -  Suspected or diagnosed cancer\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Involuntary incarceration\r\n      ","sponsor":"Harvard School of Public Health","sponsor_type":"Other","conditions":"Neoplasms|HIV|Healthcare Disparity","interventions":[{"intervention_type":"Other","name":"Other: Potlako intervention","description":"Multicomponent intervention including:\r\nprovider training on early detection and diagnostic approaches to cancer\r\npatient education on importance of obtaining timely cancer diagnosis\r\nprovision of a patient navigator to facilitate diagnosis and entry into care\r\nprovision of transportation support to vulnerable patients"}],"outcomes":[{"outcome_type":"primary","measure":"Cancer stage","time_frame":"1 day visit"},{"outcome_type":"primary","measure":"Time from initial clinic visit with cancer symptom/sign to entry into oncology care","time_frame":"1 day visit"}]}
{"nct_id":"NCT02719691","start_date":"2016-05-13","phase":"Phase 1","enrollment":49,"brief_title":"Phase I Study of MLN0128 and MLN8237 in Patients With Advanced Solid Tumors and Metastatic Triple-negative Breast Cancer","official_title":"A Phase Ib Study of the Combination of MLN0128 (Dual TORC1/2 Inhibitor) and MLN8237 (Aurora A Inhibitor, Alisertib) in Patients With Advanced Solid Tumors With an Expansion Cohort in Metastatic Triple-negative Breast Cancer (TNBC)","primary_completion_date":"2020-03-18","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-03-18","last_update":"2021-06-14","description":"This is a phase Ib study designed to evaluate the safety and toxicity of the combination of Alisertib and MLN0128 in patients with advanced solid tumors with an expansion cohort in patients with previously treated metastatic TNBC.","other_id":"15-1135.cc","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":101,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Each patient must meet all of the following inclusion criteria to be enrolled in the study:\r\n\r\n          1. Male or female patients 18 years or older.\r\n\r\n          2. Dose Escalation Cohort: Patients must have a diagnosis of a histologically confirmed\r\n             solid tumor that is incurable and refractory to standard therapy or for which no\r\n             standard therapy exists.\r\n\r\n          3. Dose Expansion Cohort Group 1 and 2: Patients must have a diagnosis of histologically\r\n             confirmed metastatic TNBC defined as negative for estrogen receptor, progesterone\r\n             receptor and HER2. Patients must have received either adjuvant or first line\r\n             chemotherapy for metastatic disease. Negative for Estrogen and Progesterone Receptor\r\n             includes the following:\r\n\r\n               -  Local Pathology report classifies them as negative\r\n\r\n               -  Allred Score of 2 or below\r\n\r\n               -  <1% positive staining Subjects with solid tumor types other than TNBC may also be\r\n                  enrolled after discussion with the Sponsor. These subjects must have a diagnosis\r\n                  of a histologically confimed solid tumor that is incurable and refractory to\r\n                  standard therapy or for which no standard therapy exists.\r\n\r\n          4. Pancreatic Cancer Cohort: Patients must have a diagnosis of locally advanced or\r\n             metastatic pancreatic adenocarcinoma previously treated with or not a candidate for\r\n             standard of care systemic therapy. Dose Expansion Cohort Group 1 and 2: At least one\r\n             tumor lesion amenable to repeat core needle biopsy or punch biopsy without\r\n             unacceptable risk of a major procedural complication.\r\n\r\n          5. Dose Expansion Cohort Group 1 and 2: At least one tumor lesion amenable to repeat core\r\n             needle biopsy or punch biopsy without unacceptable risk of a major procedural\r\n             complication.\r\n\r\n          6. Eastern Cooperative Oncology Group (ECOG) performance status < 1 (See Appendix 1)\r\n\r\n          7. Three weeks or 5 half-lives (whichever is shorter) from previous systemic anticancer\r\n             therapy; at least 4 weeks from major surgery and recovered; at least 2 weeks from\r\n             palliative radiation and recovered. No more than 450 mg/m2 cumulative dose of\r\n             doxorubicin or equivalent anthracycline dose is allowed.\r\n\r\n          8. All acute treatment-related toxicities from prior therapy must have resolved to Grade\r\n             < 1 prior to study entry excluding alopecia.\r\n\r\n          9. For women:\r\n\r\n               -  Postmenopausal for at least 1 year before the screening visit, OR\r\n\r\n               -  Surgically sterile, OR\r\n\r\n               -  If they are of childbearing potential, agree to practice 2 effective methods of\r\n                  contraception, at the same time, from the time of signing the informed consent\r\n                  through 90 days after the last dose of study drug OR agree to practice true\r\n                  abstinence, when this is in line with the preferred and usual lifestyle of the\r\n                  patient (Periodic abstinence [e.g, calendar, ovulation, symptothermal,\r\n                  postovulation methods] and withdrawal are not acceptable methods of\r\n                  contraception.\r\n\r\n             For men, even if surgically sterilized (ie, status post-vasectomy), they must:\r\n\r\n               -  Agree to practice effective barrier contraception during the entire study\r\n                  treatment period and through 120 days after the last dose of study drug, OR agree\r\n                  to practice true abstinence, when this is in line with the preferred and usual\r\n                  lifestyle of the patient (Periodic abstinence [e.g, calendar, ovulation,\r\n                  symptothermal, postovulation methods for the female partner] and withdrawal are\r\n                  not acceptable methods of contraception\r\n\r\n               -  Agree not to donate sperm during the course of this study or 120 days after\r\n                  receiving their last dose of study drug\r\n\r\n         10. Screening clinical laboratory values as specified below:\r\n\r\n               1. Bone marrow reserve consistent with: absolute neutrophil count (ANC)  1.5 x\r\n                  109/L; platelet count  100 x 109/L; hemoglobin  9 g/dL. Values must be obtained\r\n                  without the need for myeloid growth factor support, platelet or PRBC transfusion\r\n                  support within 14 days.\r\n\r\n               2. Hepatic: total bilirubin  1.5 x upper limit of normal (ULN), transaminases\r\n                  (aspartate aminotransferase/serum glutamic oxaloacetic transaminase-AST/SGOT and\r\n                  alanine aminotransferase/serum glutamic pyruvic transaminase-ALT/SGPT)  2.5 x\r\n                  ULN ( 5 x ULN if liver metastases are present);\r\n\r\n               3. Renal: Creatinine < 1.5 X ULN or creatinine clearance  50 mL/min based either on\r\n                  Cockroft-Gault estimate or based on urine collection (12 or 24 hour)(Appendix 2);\r\n\r\n               4. Metabolic: Glycosylated hemoglobin (HbA1c)<7.0%, fasting serum glucose ( 130\r\n                  mg/dL) and fasting triglycerides  300 mg/dL;\r\n\r\n               5. For patients undergoing serial tumor biopsies, INR and activated partial\r\n                  thromboplastin time (PTT) must be within 1.5 X the upper limit of normal.\r\n\r\n         11. Left ventricular ejection fraction (LVEF) > LLN of the institutional standard of\r\n             normal as measured by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA)\r\n             within 4 weeks prior to first study drug administration.\r\n\r\n         12. Ability to swallow oral medications.\r\n\r\n         13. Voluntary written consent must be given before performance of any study related\r\n             procedure not part of standard medical care, with the understanding that consent may\r\n             be withdrawn by the patient at any time without prejudice to future medical care.\r\n\r\n         14. Patients who have a history of brain metastasis are eligible for the study provided\r\n             that all the following criteria are met:\r\n\r\n               1. Brain metastases which have been treated\r\n\r\n               2. No evidence of disease progression for  4 weeks or hemorrhage after treatment\r\n\r\n               3. Off-treatment with dexamethasone for 2 weeks before administration of the first\r\n                  dose of MLN0128\r\n\r\n               4. No ongoing requirement for dexamathasone or anti-epileptic drugs.\r\n\r\n        Exclusion Criteria\r\n\r\n        Patients meeting any of the following exclusion criteria are not to be enrolled in the\r\n        study:\r\n\r\n          1. Other clinically significant co-morbidities, such as uncontrolled pulmonary disease,\r\n             active central nervous system disease, active infection, or any other condition that\r\n             could compromise the patient's participation in the study.\r\n\r\n          2. Known human immunodeficiency virus infection.\r\n\r\n          3. Radiation therapy to more than 25% of the bone marrow. Whole pelvic radiation is\r\n             considered to be over 25%.\r\n\r\n          4. Known history of uncontrolled sleep apnea syndrome and other conditions that could\r\n             result in excessive daytime sleepiness, such as severe chronic obstructive pulmonary\r\n             disease; requirement for supplemental oxygen.\r\n\r\n          5. Systemic infection requiring IV antibiotic therapy within 14 days preceding the first\r\n             dose of study drug, or other severe infection.\r\n\r\n          6. Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C\r\n             infection.\r\n\r\n          7. Any serious medical or psychiatric illness that could, in the investigator's opinion,\r\n             potentially interfere with the completion of treatment according to this protocol.\r\n\r\n          8. Diagnosed or treated for another malignancy within 2 years before administration of\r\n             the first dose of study drug, or previously diagnosed with another malignancy and have\r\n             any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma\r\n             in situ of any type are not excluded if they have undergone complete resection.\r\n\r\n          9. Breast feeding or pregnant.\r\n\r\n         10. Manifestations of malabsorption due to prior gastrointestinal (GI) surgery, GI\r\n             disease, or for an unknown reason that may alter the absorption of MLN0128. In\r\n             addition, patients with enteric stomata are also excluded.\r\n\r\n         11. Treatment with any investigational products within 3 weeks before the first dose of\r\n             study drug.\r\n\r\n         12. History of any of the following within the last 6 months before administration of the\r\n             first dose of the drug:\r\n\r\n               1. Ischemic myocardial event, including angina requiring therapy and artery\r\n                  revascularization procedures\r\n\r\n               2. Ischemic cerebrovascular event, including transient ischemic attack and artery\r\n                  revascularization procedures\r\n\r\n               3. Requirement for inotropic support (excluding digoxin) or serious (uncontrolled)\r\n                  cardiac arrhythmia (including atrial flutter/fibrillation, ventricular\r\n                  fibrillation or ventricular tachycardia)\r\n\r\n               4. Placement of a pacemaker for control of rhythm\r\n\r\n               5. New York Heart Association (NYHA) Class III or IV heart failure (See Appendix 3)\r\n\r\n               6. Pulmonary embolism\r\n\r\n         13. Significant active cardiovascular or pulmonary disease including:\r\n\r\n               1. Uncontrolled hypertension (i.e., systolic blood pressure >180 mm Hg, diastolic\r\n                  blood pressure > 95 mm Hg). Use of anti-hypertensive agents to control\r\n                  hypertension before Cycle1 Day 1 is allowed.\r\n\r\n               2. Pulmonary hypertension\r\n\r\n               3. Uncontrolled asthma or O2 saturation < 90% by arterial blood gas analysis or\r\n                  pulse oximetry on room air\r\n\r\n               4. Significant valvular disease; severe regurgitation or stenosis by imaging\r\n                  independent of symptom control with medical intervention, or history of valve\r\n                  replacement\r\n\r\n               5. Medically significant (symptomatic) bradycardia\r\n\r\n               6. History of arrhythmia requiring an implantable cardiac defibrillator\r\n\r\n               7. Baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated\r\n                  demonstration of QTc interval > 480 milliseconds, or history of congenital long\r\n                  QT syndrome, or torsades de pointes)\r\n\r\n         14. Treatment with strong inhibitors and/or inducers of cytochrome P450 (CYP) 3A4, CYP2C19\r\n             or CYP2C19 within 1 week preceding the first dose of study drug.\r\n\r\n         15. Patients receiving systemic corticosteroids (either IV or oral steroids, excluding\r\n             inhalers or low-dose hormone replacement therapy) within 1 week before administration\r\n             of the first dose of study drug.\r\n\r\n         16. Daily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within\r\n             7 days before receiving the first dose of study drug.\r\n\r\n         17. For patients undergoing serial tumor biopsies, known bleeding diathesis or history of\r\n             abnormal bleeding or require anti-coagulation therapy which cannot be interrupted for\r\n             biopsy.\r\n      ","sponsor":"University of Colorado, Denver","sponsor_type":"Other","conditions":"Metastatic Breast Cancer|Solid Tumors","interventions":[{"intervention_type":"Drug","name":"Drug: Alisertib","description":"Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study."},{"intervention_type":"Drug","name":"Drug: MLN0128","description":"Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study."}],"outcomes":[{"outcome_type":"primary","measure":"Determine the maximum tolerated dose (MTD) in the combination of MLN0128 and Alisertib in patients with advanced solid tumors measured by treatment adverse events as assessed by the CTCAE v4.03","time_frame":"Up to 28 days","description":"The maximum tolerated dose (MTD) will be defined as the highest dose level evaluated in which 0 or 1 patient out of 6 patients experiences dose limiting toxicity (DLT) in the combination of MLN0128 and Alisertib. Toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03."},{"outcome_type":"secondary","measure":"Number of patients that experience an adverse event from MLN0128 and Alisertib in combination measured by treatment adverse events as assessed by the CTCAE v4.03","time_frame":"At least 30 days after the last dose of MLN0128 or alisertib","description":"Adverse events will be tabulated by type and grade according to the NCI CTCAE v.4.03."}]}
{"nct_id":"NCT03972540","start_date":"2016-05-09","phase":"N/A","enrollment":13,"brief_title":"Effect of Mindful Eating on Weight Management in Breast Cancer Survivors","official_title":"Effect of a Mindful Eating Intervention on Weight Management in Overweight and Obese Postmenopausal Breast Cancer Survivors","primary_completion_date":"2016-07-29","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-10-31","last_update":"2019-06-03","description":"This pilot study examined changes in anthropometric measures as a result of and feasibility/ acceptability of a mindful eating intervention for overweight and obese postmenopausal breast cancer survivors.","other_id":"STUDY00002818","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Postmenopausal female\r\n\r\n          -  Breast cancer survivor (in remission)\r\n\r\n          -  Completed cancer treatment at the time of study enrollment\r\n\r\n          -  Body Mass Index (BMI) equal or greater than 25 kg/m\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  None.\r\n      ","sponsor":"University of Georgia","sponsor_type":"Other","conditions":"Breast Neoplasm Female","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Mindful eating intervention","description":"A Mindful Eating Workshop workbook was used for standardization and reproducibility of these sessions. The group sessions were focused on teaching applied strategies to consume food with intention and attention and aimed at improving emotional relationships with food. Intervention sessions were held once a week in the evening for 2 hours per session over 8 weeks. The intervention was delivered in a large conference room on the University of Georgia campus. Participants were required to attend seven out of eight sessions. If participants missed a session, they met with the instructor 30 minutes before the beginning of the following week's session to receive individual instruction on content of the missed session."}],"outcomes":[{"outcome_type":"primary","measure":"Body Mass Index","time_frame":"Change measured between weeks 1 and 12","description":"At the baseline and follow-up visits, trained study staff measured participants' weight and height using a standardized protocol. Height (measured by a stadiometer to the nearest 0.1 cm) and weight (measured by a scale to the nearest 0.1 kg) was used to calculate BMI (weight in kg divided by height in m²)."},{"outcome_type":"primary","measure":"Blood Pressure","time_frame":"Change measured between weeks 1 and 12","description":"At the baseline and follow-up visits, trained study staff measured participants' systolic/diastolic blood pressure using a standardized protocol to the nearest mmHg. In order to ensure reliability, all measurements were taken 3 times and average values were used for analyses."},{"outcome_type":"primary","measure":"Waste and Hip Circumference","time_frame":"Change measured between weeks 1 and 12","description":"At the baseline and follow-up visits, trained study staff measured participants' waist and hip circumference by tape measure to the nearest 0.1 centimeter."},{"outcome_type":"primary","measure":"Body Fat Percentage","time_frame":"Change measured between weeks 1 and 12","description":"At the baseline and follow-up visits, trained study staff measured participants' body fat percentage using a bioelectrical impedance analyzer (BIA)."},{"outcome_type":"primary","measure":"Feasibility of Conducting the Intervention","time_frame":"Measured at week 12","description":"Feasibility was assessed by tracking participant accrual and retention rates."},{"outcome_type":"primary","measure":"Acceptability of the Intervention","time_frame":"Measured at week 12","description":"To measure acceptability, participants were asked to complete a 5-question feedback survey to evaluate the mindful eating intervention at the follow-up study visit. Specifically, the open-ended survey questions asked participants about (1) their experience with intervention, (2) how the intervention affected diet and exercise management, (3) positive aspects about the intervention, (4) negative aspects about the intervention, and (5) suggested changes to the intervention. Qualitative data analysis techniques were used to identify themes within the data."},{"outcome_type":"secondary","measure":"Mindful Eating Measures","time_frame":"Change measured between weeks 1 and 12","description":"Changes in mindfulness resulting from the intervention were measured using the validated Mindful Attention Awareness Scale (MAAS). The MAAS questionnaire is a 15-item scale that was designed to assess mindfulness and receptive awareness throughout an individual's daily life. Scores from the MAAS range from 1 to 6, with higher scores associated with higher mindfulness. The MAAS was validated for use in cancer populations against the Profile of Mood States (POMS) scale that is widely used in clinical settings. Higher MAAS scores were significantly correlated with lower POMS scores, further confirming the construct validity of the MAAS questionnaire for assessing mindfulness in cancer populations. The questionnaire was self-administered to the participants pre and post intervention."},{"outcome_type":"other","measure":"Nutritional Intake","time_frame":"Change measured between weeks 1 and 12","description":"Habitual nutritional intake was measured using an electronic version of the Block Food Frequency Questionnaire, a 127-item food and beverage recall instrument referencing the consumption over the past month. Dietary intake data was describes as daily energy consumption (kcal), consumption of macronutrients (fat, protein, carbohydrate; grams/day), and intake of sweets (% of daily intake) to compare intake before intervention start with intake during the intervention."},{"outcome_type":"other","measure":"Physical Activity","time_frame":"Change measured between weeks 1 and 12","description":"Participants' physical activity levels (average daily steps; moderate-to-vigorous physical activity (MVPA) minutes) were tracked throughout the study period using FitBit® Flex accelerometers. Total daily steps and MVPA minutes were averaged for the first and the last week of the intervention to examine changes."}]}
{"nct_id":"NCT03937284","start_date":"2016-05-03","enrollment":45,"brief_title":"Lipoprotein Metabolism and Bacterial Lipopolysaccharide in Parkinson's Disease","official_title":"Lipoprotein Lipidic Composition, Lipopolysaccharide Binding Protein, and Bacterial Endotoxin Exposure in Parkinson's Disease: A Pilot Study","primary_completion_date":"2017-10-20","study_type":"Observational","rec_status":"Completed","completion_date":"2017-10-20","last_update":"2019-05-03","description":"Patients with Parkinson's disease (PD) present an impaired intestinal permeability with consequent lipopolysaccharide (LPS) translocation in the systemic circulation. Plasmatic lipoproteins play a key role in the detoxification of LPS. The investigators aim to study the relationships between lipoprotein chemical composition and plasma LPS circulation in PD.","other_id":"Unimi","observational_model":"Case-Only","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Parkinson affected patients and healthy controls matched for sex, age and BMI in agreement\r\n        with inclusion criteria.","criteria":"\n        Parkinson's patients\r\n\r\n        Inclusion Criteria:\r\n\r\n          -  Diagnosis of Parkinson disease in agreement with UK Brain Bank\r\n\r\n          -  Farmacological treatment with L-Dopa and/or dopaminergic agonist or diagnosis de novo\r\n\r\n          -  BMI 18.5 - 29.9 kg/m^2\r\n\r\n          -  Informed consent signature\r\n\r\n        Exclusion criteria:\r\n\r\n          -  Presence of type 1 and type 2 diabetes mellitus\r\n\r\n          -  Presence of major chronic diseases of the digestive tract.\r\n\r\n          -  Pregnancy in progress\r\n\r\n          -  Subjects subjected to antihypertensive therapies or statins or with drugs that can\r\n             change metabolic status and insulin sensitivity (e.g. chronic oral steroid therapy)\r\n\r\n          -  Subjects affected by endocrine pathologies (e.g. Cushing disease, uncontrolled thyroid\r\n             disease)\r\n\r\n          -  Presence of known renal insufficiency or creatinine levels greater than 1.8 mg/dl\r\n\r\n          -  Presence of chronic liver disease or ALT and AST levels exceeding two standard\r\n             deviations from normal levels\r\n\r\n          -  Presence of malignant disease\r\n\r\n          -  Alcohol or drug abuse\r\n\r\n          -  Major psychiatric disorders\r\n\r\n          -  Subjects dedicated to intense and agonistic physical activity.\r\n\r\n        Control group\r\n\r\n        Inclusion criteria\r\n\r\n          -  Absence of major disease\r\n\r\n          -  BMI 18.5 - 29.9 kg/m^2\r\n\r\n          -  Informed consent signature\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Presence of type 1 and type 2 diabetes mellitus\r\n\r\n          -  Presence of major chronic diseases of the digestive tract.\r\n\r\n          -  Pregnancy in progress\r\n\r\n          -  Subjects subjected to antihypertensive therapies or statins or with drugs that can\r\n             change metabolic status and insulin sensitivity (e.g. chronic oral steroid therapy)\r\n\r\n          -  Subjects affected by endocrine pathologies (e.g. Cushing disease, uncontrolled thyroid\r\n             disease)\r\n\r\n          -  Presence of known renal insufficiency or creatinine levels greater than 1.8 mg/dl\r\n\r\n          -  Presence of chronic liver disease or ALT and AST levels exceeding two standard\r\n             deviations from normal levels\r\n\r\n          -  Presence of malignant disease\r\n\r\n          -  Alcohol or drug abuse\r\n\r\n          -  Major psychiatric disorders\r\n\r\n          -  Subjects dedicated to intense and agonistic physical activity.\r\n      ","sponsor":"University of Milan","sponsor_type":"Other","conditions":"Parkinson Disease","interventions":[{"intervention_type":"Other","name":"Other: Patients not treated"}],"outcomes":[{"outcome_type":"primary","measure":"LPS","time_frame":"through study completion an average of 1 year","description":"LPS plasma levels (EU/L)"},{"outcome_type":"primary","measure":"Lipoprotein chemical composition","time_frame":"through study completion an average of 1 year","description":"Cholesterol (mg/dL); HDL-cholesterol (mg/dL); triglycerides (mg/dL); phospholipids (mg/dL), apoproteins (mg/dL) of VLDL, LDL and HDL"},{"outcome_type":"secondary","measure":"Plasma lipid transfer proteins","time_frame":"through study completion an average of 1 year","description":"Lipopolysaccharide binding protein (ng/mL), cholesterol ester transfer protein (ng/mL), phospholipid transfer protein (ng/mL)"}]}
{"nct_id":"NCT04284644","start_date":"2016-05-01","phase":"N/A","enrollment":105,"brief_title":"Co-induction Technique Compared to Standard Inhalational and Intravenous Induction Techniques","official_title":"A Novel Co-induction Technique Compared to Standard Inhalational and Intravenous Induction Techniques: a Prospective Randomized Control Study","primary_completion_date":"2017-01-02","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-01-03","last_update":"2020-02-26","description":"Co-induction technique refers to the use of a combination of medications to reach the desired therapeutic target. In the present study, the investigators examined the safety of a novel co-induction approach that relied on a simple timing and dosing alterations to the classical approaches of inhalational sevoflurane and propofol induction. The significance of this study is to find a reliable safe alternative method of induction that can provide optimal parameters,when compared to the classical methods of induction.","other_id":"10/2016/4597","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  patients with Age  65 years.\r\n\r\n          -  American Society of Anaesthesiologists' (ASA) score II or III.\r\n\r\n          -  minimally invasive endoscopic urological procedures.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  patient refusal.\r\n\r\n          -  Age < 65 years.\r\n\r\n          -  family history of malignant hyperthermia.\r\n\r\n          -  prolonged surgery that needed intubation.\r\n\r\n          -  body mass index (BMI) > 35 kg/m2.\r\n      ","sponsor":"University of Jordan","sponsor_type":"Other","conditions":"Anesthesia|Anesthesia; Adverse Effect","interventions":[{"intervention_type":"Drug","name":"Drug: Induction using propofol","description":"Patients were given 1.5 mcg/Kg of fentanyl intravenously. two minutes after the fentanyl dose, a dose of 1.5 mg/kg of propofol slowly over 2 minutes."},{"intervention_type":"Drug","name":"Drug: Induction using sevoflurane","description":"Patients were given 1.5 mcg/Kg of fentanyl intravenously. two minutes after the fentanyl dose, patient received 8% inhalational sevoflurane through sealed plastic face mask at 8 L/min flow of oxygen."},{"intervention_type":"Drug","name":"Drug: Induction using propofol and sevoflurane","description":"Patients were given 1.5 mcg/Kg of fentanyl intravenously. two minutes after the fentanyl dose, patient received 4% sevoflurane through sealed plastic face mask at 8 L/min flow of oxygen for 2 minutes, followed by a dose of 0.75 mg/kg of propofol given slowly."}],"outcomes":[{"outcome_type":"primary","measure":"Intraoperative respiratory adverse events","time_frame":"8 months","description":"The investigators recorded the occurrence of transient apnea intraoperatively, in addition to laryngeal spasm, coughing, gagging and increased salivation. The study chart included the documentation these common adverse events, the timing of occurrence, and the intervention required to manage these events."},{"outcome_type":"secondary","measure":"Time for successful laryngeal mask airway insertion","time_frame":"8 months","description":"The investigators assessed the time needed for LMA insertion. The timer was started upon giving the fentanyl, recording the time till successful insertion of laryngeal mask airway."},{"outcome_type":"secondary","measure":"Blood pressure stability","time_frame":"8 months","description":"The investigators recorded patients' blood pressure readings throughout the induction procedure."},{"outcome_type":"secondary","measure":"Heart rate stability","time_frame":"8 months","description":"The investigators recorded patients' heart rate throughout the induction procedure."},{"outcome_type":"secondary","measure":"Changes in oxygen saturation","time_frame":"8 months","description":"The investigators recorded patients' oxygen saturation throughout the induction procedure."}]}
{"nct_id":"NCT02896491","start_date":"2016-05-01","phase":"N/A","enrollment":30,"brief_title":"RF-EMF Effects on the CNS in Elderly Men","official_title":"Radiofrequency Electromagnetic Fields (RF-EMF) Effects on Brain Activity During Wake and Sleep in Healthy Elderly Males","primary_completion_date":"2018-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-05-31","last_update":"2021-02-10","description":"To investigate possible effects of radio frequency electromagnetic fields on EEG activity during sleep and on Brain function during wake (EEG in the resting state condition, slow EEG potentials, auditory evoked potentials) and cognitive performance measures in test of selective attention, divided attention and working memory in healthy elderly males (60 - 80 years).","other_id":"3616S82430","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Basic Science","masking_description":"Triple","sampling_method":"","gender":"Male","minimum_age":60,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  healthy male subjects (age 60 - 80 years)\r\n\r\n          -  right handedness\r\n\r\n          -  alpha EEG as resting state EEG\r\n\r\n          -  non-smokers\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  acute illness\r\n\r\n          -  severe neurological, psychiatric or internal disease\r\n\r\n          -  CNS active medication\r\n\r\n          -  sleep disorders\r\n\r\n          -  drug abuse\r\n      ","sponsor":"The Federal Office for Radiation Protection, Germany","sponsor_type":"Other","conditions":"Non-Ionizing Radiation","interventions":[{"intervention_type":"Radiation","name":"Radiation: Exposure with non-ionizing electromagnetic fields","description":"In a cross-over design subjects will be exposed to sham (placebo), GSM 900 MHz (2W/kg) and TETRA (6W/kg)"}],"outcomes":[{"outcome_type":"primary","measure":"sleep EEG (power)","time_frame":"during exposure for 8 hours"},{"outcome_type":"secondary","measure":"resting state Waking EEG (power)","time_frame":"during exposure 4 hours"}]}
{"nct_id":"NCT02743936","start_date":"2016-04-30","phase":"Phase 4","enrollment":64,"brief_title":"Mask Leak With Nasal Cannula in Noninvasive Positive Pressure Ventilation","official_title":"Analysis of Face Mask Leak With Nasal Cannula in Noninvasive Positive Pressure Ventilation: A Randomized Crossover Trial","primary_completion_date":"2016-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-05-31","last_update":"2016-09-26","description":"This is a prospective randomized cross over study of healthy volunteers undergoing continuous positive airway pressure ventilation via a noninvasive ventilation (NIV) mask with and without the addition of nasal cannulas. Mask leak will be measured by the ventilator after 60 seconds of spontaneous resting ventilation, with each subject serving as his or her own control.","other_id":"C.2016.030d","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18 years of age\r\n\r\n          -  Volunteer for study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Known cardiac disease\r\n\r\n          -  Known pulmonary disease (to include respiratory infections)\r\n      ","sponsor":"Brooke Army Medical Center","sponsor_type":"U.S. Fed","conditions":"Mechanical Ventilation Pressure High","interventions":[{"intervention_type":"Device","name":"Device: Nasal cannula","description":"Placement of nasal cannula under non-invasive positive pressure ventilation mask"},{"intervention_type":"Device","name":"Device: Non-invasive positive pressure ventilation","description":"Non-invasive positive pressure ventilation"}],"outcomes":[{"outcome_type":"primary","measure":"Face Mask Leak Measured in Liters Per Minute by the Noninvasive Positive Pressure Ventilation Machine","time_frame":"2 minutes after mask placement","description":"Face mask leak as measured in liters per minute by the noninvasive positive pressure ventilation machine"},{"outcome_type":"secondary","measure":"Patient Discomfort (Verbal Numerical Rating Scale)","time_frame":"After study completion (approximately 2 minutes after study start)","description":"Discomfort scored on a 0-10 verbal numerical rating scale (0 = no discomfort, 10 = most discomfort imaginable)"}]}
{"nct_id":"NCT02582463","start_date":"2016-04-30","enrollment":1552,"brief_title":"Development of the Medicines Optimisation Assessment Tool","official_title":"Development of the Medicines Optimisation Assessment Tool (MOAT) - Targeting Hospital Pharmacists' Input to Reduce Risks and Improve Patient Outcomes","primary_completion_date":"2017-08-31","study_type":"Observational","rec_status":"Completed","completion_date":"2018-03-02","last_update":"2018-03-29","description":"The purpose of this study is to develop a prediction-tool, the Medicines Optimisation Assessment Tool (MOAT), to assist hospital pharmacists identify patients at highest risk of preventable medication related problems (MRPs). This has the potential to permit pharmacists to identify and focus on the small number of patients (approximately 6%) who are likely to experience a significant MRP while in hospital.","other_id":"15/0525","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients admitted to the Medical Division (General, Emergency, and Elderly Medicine) at the\r\n        Luton and Dunstable University Hospital and Watford General Hospital","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  subject admitted to the Medical Division (General, Emergency, and Elderly Medicine) at\r\n             the study sites\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  subject admitted for investigation-only\r\n\r\n          -  subject not prescribed medication\r\n\r\n          -  subject both admitted and subsequently discharged outside of core pharmacy working\r\n             hours\r\n      ","sponsor":"University College, London","sponsor_type":"Other","conditions":"Medicines Optimisation","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Number of MRPs experienced by study participants","time_frame":"Through study completion (discharge from hospital), an average of 6 days","description":"The outcome measure (i.e. all MRPs) will be graded for severity and preventability, then multivariate analysis such as logistic regression models will be used to determine the relationship between predictors (prognostic factors) and the outcome (MRPs which are at least moderate in severity and preventable). The objective will be to find the best combinations of predictors that are highly sensitive for detecting the outcome measure while achieving the maximum possible specificity."},{"outcome_type":"secondary","measure":"Feasibility of using the MOAT (content validity and ease of use)","time_frame":"18 months","description":"Content validity will be assessed to ensure that clinicians consider the items in the MOAT to be clinically sensible, no obvious items are missing, the method of grouping the individual predictors is reasonable, and the items seem appropriate for the purpose of the tool. Ease of use depends on the length of time needed to apply the tool and the simplicity of interpretation. A consensus development technique will be used to generate consensus on content validity and simplicity of interpretation. Time to apply the MOAT will be assessed by observation."},{"outcome_type":"secondary","measure":"Potential efficiency savings","time_frame":"18 months","description":"The impact of the MOAT in terms of potential workload for pharmacists will be informed by the number of patients who screen positive (from internal validation). This will indicate the proportion of patients who would be expected to require review by a pharmacist, i.e. the total number that pharmacists would need to see to identify those at highest risk of MRPs."},{"outcome_type":"secondary","measure":"Potential clinical risk to patients through use of the MOAT","time_frame":"18 months","description":"Patients who experience an MRP but would be excluded from pharmacist review by the MOAT (i.e. false negatives) will be reviewed in detail to identify the potential clinical risk (i.e. severity of missed events)."}]}
{"nct_id":"NCT02794298","start_date":"2016-04-30","phase":"N/A","enrollment":32,"brief_title":"tDCS Effects on GABA Concentration and Brain Functional Connectivity in Young Adults","official_title":"Effects of Transcranial Direct Current Stimulation (tDCS) on GABA Concentration and Brain Functional Connectivity in Young Adults.","primary_completion_date":"2016-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-12-31","last_update":"2017-01-06","description":"The aim of this study is to investigate whether anodal tDCS over the left M1 leads to a decrease of GABA concentration and alterations of functional brain connectivity in younger people, compared to sham tDCS.","other_id":"TRAINSTIM1.C","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":30,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  unobtrusive neuropsychological screening\r\n\r\n          -  age: young adults: 18-30 years\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Mild cognitive impairment (MCI) or other neurological diseases\r\n\r\n          -  History of severe alcoholism or use of drugs\r\n\r\n          -  Severe psychiatric disorders such as depression, psychosis (if not in remission) and\r\n             severe untreated medical problems\r\n\r\n          -  Contraindication for MRI (claustrophobia, metallic implants, ferromagnetic metals in\r\n             the body, disorders of thermoregulation, pregnant women)\r\n      ","sponsor":"Charite University, Berlin, Germany","sponsor_type":"Other","conditions":"Healthy Young Adults","interventions":[{"intervention_type":"Device","name":"Device: Transcranial direct current stimulation (tDCS)"},{"intervention_type":"Device","name":"Device: sham-tDCS"}],"outcomes":[{"outcome_type":"primary","measure":"Measurement of GABA concentration by magnetic resonance spectroscopy (MRS) after anodal tDCS adjusted for baseline levels.","time_frame":"assessed immediately before and after a 15-min stimulation time","description":"Investigation whether anodal tDCS leads to a significant reduction of M1-GABA concentration in younger adults compared to sham stimulation."},{"outcome_type":"secondary","measure":"GABA concentration assessed by MRS after cathodal tDCS adjusted for baseline levels","time_frame":"assessed immediately before and after a 15-min stimulation time","description":"To assess stimulation effects on GABA concentration by magnetic resonance spectroscopy are measured before and after cathodal tDCS."},{"outcome_type":"secondary","measure":"Resting-state functional connectivity changes","time_frame":"assessed during a 15-min stimulation time","description":"Functional connectivity as measured by resting-state fMRI during tDCS compared to sham"},{"outcome_type":"secondary","measure":"Genotyping of learning related polymorphisms.","time_frame":"assessed during baseline screening","description":"To assess predictors of positive reaction to brain stimulation, genotyping of several learning related polymorphisms will be performed."}]}
{"nct_id":"NCT02724098","start_date":"2016-04-30","phase":"Phase 4","enrollment":10,"brief_title":"Bioavailability of Subcutaneous Dexmedetomidine","official_title":"Bioavailability of Subcutaneously Given Dexmedetomidine in Healthy Volunteers","primary_completion_date":"2016-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-05-31","last_update":"2017-09-12","description":"The aim of this study is to investigate the pharmacokinetics of subcutaneously administered dexmedetomidine in healthy volunteers. The absolute bioavailability of subcutaneously administered dexmedetomidine will be calculated. In addition, the investigators will report the effects of subcutaneously administered dexmedetomidine on plasma catecholamine levels, vital signs such as systemic blood pressure, heart rate and sedation. The investigators will also monitor the local and systemic safety and tolerability of subcutaneously administered dexmedetomidine.","other_id":"T30/2016","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Fluent skills in the Finnish language in order to be able to give informed consent and\r\n             communicate with the study personnel.\r\n\r\n          -  Age  18 years.\r\n\r\n          -  Male gender.\r\n\r\n          -  Weight  60 kg.\r\n\r\n          -  Written informed consent from the subject.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Previous history of intolerance to the study drug or related compounds and additives.\r\n\r\n          -  Concomitant drug therapy of any kind except paracetamol in the 14 days prior to the\r\n             study.\r\n\r\n          -  Existing or recent significant disease.\r\n\r\n          -  History of any kind of drug allergy.\r\n\r\n          -  Previous or present alcoholism, drug abuse, psychological or other emotional problems\r\n             that are likely to invalidate informed consent, or limit the ability of the subject to\r\n             comply with the protocol requirements.\r\n\r\n          -  Donation of blood within six weeks prior to and during the study.\r\n\r\n          -  Body weight < 60 kg or BMI > 30 kg / m2.\r\n\r\n          -  Participation in any other clinical study involving investigational or marketed drug\r\n             products concomitantly or within one month prior to the entry into this study.\r\n\r\n          -  Smoking during one month before the start of the study or during the study period.\r\n\r\n          -  Clinically significant abnormal findings in physical examination, ECG or laboratory\r\n             screening\r\n      ","sponsor":"Turku University Hospital","sponsor_type":"Other","conditions":"Pain","interventions":[{"intervention_type":"Drug","name":"Drug: Dexmedetomidine"}],"outcomes":[{"outcome_type":"primary","measure":"Bioavailability (%) of subcutaneously given dexmedetomidine","time_frame":"10 hours","description":"Noncompartmental analysis after non-linear mixed effects modelling."},{"outcome_type":"secondary","measure":"Change in hemodynamic parameter (blood pressure)","time_frame":"10 hours","description":"More than 30% change from the baseline in the blood pressure (measured in mmHg)"},{"outcome_type":"secondary","measure":"Number of participants with adverse events as a measure of safety and tolerability","time_frame":"7 days"},{"outcome_type":"secondary","measure":"Change in hemodynamic parameter (heart rate)","time_frame":"10 hours","description":"More than 30% change from the baseline in the blood pressure (measured in beats/minute)"}]}
{"nct_id":"NCT02074306","start_date":"2016-04-30","phase":"N/A","enrollment":66,"brief_title":"Does UROSHIELD Influence Bacterial Growth On Endotracheal Tubes","official_title":"Does UROSHIELD Influence Bacterial Growth On Endotracheal Tubes","primary_completion_date":"2018-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2018-12-31","last_update":"2018-08-07","description":"The purpose of this study is to examine the effect of UROSHIELD (a device which generates low energy ultrasound waves) on development of bacterial colonies on endotracheal tubes, in patient receiving mechanical ventilation, and to determine whether this device lowers the rate of bacterial resistance to antibiotics.","other_id":"109/13","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Consecutive adult patients, with newly begun mechanical ventilation, will be connected\r\n             to UROSHIELD within 48 hours\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pediatric patients\r\n      ","sponsor":"Shaare Zedek Medical Center","sponsor_type":"Other","conditions":"Mechanical Ventilation Complication","interventions":[{"intervention_type":"Device","name":"Device: UROSHIELD","description":"An active UROSHIELD device (low energy acustic wave generator) will be connected to an intratracheal tube externally. The device will transform low energy ultrasound waves on to the tube. These waves will by assumption lower the formation of bacterial growth and resistance to antibiotics."},{"intervention_type":"Device","name":"Device: SHAM UROSHIELD","description":"SHAM UROSHIELD will be connected to endotracheal tubes unable to transform any waves."}],"outcomes":[{"outcome_type":"primary","measure":"Number of days elapse until development of positive sputum culture","time_frame":"15-20 days","description":"Sputum for culture will be obtained every 3 days. Number of days till sputum culture will convert from negative to positive one will be calculated and compared for the study and control groups."},{"outcome_type":"secondary","measure":"Type of bacteria and antibiotic sensitivity","time_frame":"15-20 days","description":"Types of bacteria and their sensitivities to antibiotics will be evaluated. Comparison will be done between rate of growth of serious pathogens (e.g., Methicillin resistant staphylococcus aureus (MRSA),Vancomycin-Resistant Enterococci (VRE)) in the study and control groups.\r\nRate of resistance development to antibiotics will also be compared."}]}
{"nct_id":"NCT02974478","start_date":"2016-04-30","phase":"N/A","enrollment":26,"brief_title":"Orange Juice Consumption and Glucose Metabolism and Antioxidative Status","official_title":"Impact of Orange Juice Consumption on Glucose Homeostasis and Antioxidative Status in Healthy Subjects","primary_completion_date":"2016-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-12-31","last_update":"2017-04-25","description":"Aim of the study is to investigate the impact of orange juice consumption (with meals or between meals) as well as sugar sweetened beverage (SSB) consumption (between meals) on glucose homeostasis and antioxidative status.","other_id":"OrangeJuice","allocation":"Non-Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  healthy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  regular use of medication,\r\n\r\n          -  smoking,\r\n\r\n          -  chronic disease,\r\n\r\n          -  vegan/vegetarian diet,\r\n\r\n          -  fructose intolerance,\r\n\r\n          -  irregular eating behaviour (less then 3 meals/day)\r\n      ","sponsor":"University of Hohenheim","sponsor_type":"Other","conditions":"Healthy","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Orange juice with meals","description":"orange juice (20% of energy requirement/day)"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Orange juice between meals","description":"orange juice (20% of energy requirement/day)"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Sugar sweetened beverage between meals","description":"Sugar sweetened beverage (20% of energy requirement/day)"}],"outcomes":[{"outcome_type":"primary","measure":"changes in daylong glycaemia between pre and post intervention periods","time_frame":"two weeks","description":"measured via continuous glucose monitoring [mg/dL]"},{"outcome_type":"secondary","measure":"changes in uric acid between pre and post intervention periods","time_frame":"two weeks","description":"measured via uric acid serum levels [mg/dL]"},{"outcome_type":"secondary","measure":"changes in insulin sensitivity between pre and post intervention periods","time_frame":"two weeks","description":"measured via \"Matsuda-Index\" from oral glucose tolerance test data"},{"outcome_type":"secondary","measure":"changes in antioxidative status between pre and post intervention periods","time_frame":"two weeks","description":"measured via vitamin c blood levels [mg/L]"}]}
{"nct_id":"NCT02761772","start_date":"2016-04-30","enrollment":210,"brief_title":"Early Pregnancy Cohort and Preimplantation Factor","official_title":"Prospective Early Pregnancy Cohort and Preimplantation Factor: Factors Related to Successful Implantation, Risk of Miscarriage and Recurrent Pregnancy Loss in the First Trimester","primary_completion_date":"2017-09-30","study_type":"Observational [Patient Registry]","rec_status":"Completed","completion_date":"2018-12-31","last_update":"2019-03-27","description":"Miscarriage is a common event associated with severe psychological and social morbidity, further tormenting in women suffering recurrent pregnancy loss (RPL) by at least three consecutive losses. Ultrasonography and biomarkers have yet to precisely predict viability in pregnancies with symptoms of threatening miscarriage. A novel biomarker Preimplantation Factor (PIF) derived by the developing embryo might be the key factor for this prediction ameliorating the implantation process by promoting a favorable local immune system in the uterus. The investigators aim to establish a prospective early pregnancy cohort (PEP-cohort) that includes women throughout the first trimester by both assisted reproductive technology (ART) and spontaneous conceptions. By a combination of consecutive ultrasonographys and blood samples of known predictors of implantation PIF as a predictor of viability will be evaluated. These data are finally compared to the same data in a retrospective cohort of RPL patients emphasizing the role of PIF. All collected data will be stored in a Research Biobank for the current studies outlined as well as potential future studies of reproductive medicine in the first trimester.","other_id":"PEP-PIF-2016","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"Female","minimum_age":18,"population":"PEP-A: Women in ART treatment by natural cycles of frozen embryo transfer at North Zealand\r\n        Hospital and Rigshospitalet.\r\n\r\n        PEP-S: Women with a positive pregnancy test by spontaneous conception, prior to eight weeks\r\n        of gestation.","criteria":"\n        PEP-A\r\n\r\n        Inclusion Criteria:\r\n\r\n          1. Women in ART treatment by natural cycle frozen embryo transfer only monitored by urine\r\n             LH.\r\n\r\n          2. Age above 18 years.\r\n\r\n          3. Ability to understand read and write Danish for the informed consent.\r\n\r\n          4. Planned delivery at the hospitals involved in the project.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Abnormal uterine anatomy or function already known or estimated at first transvaginal\r\n             ultrasonography.\r\n\r\n          2. History of recurrent pregnancy loss.\r\n\r\n          3. Ongoing or former (at least 12 months of no use) narcotics or alcohol abuse (above 14\r\n             units of alcohol per week).\r\n\r\n          4. Contraindication for pregnancy.\r\n\r\n        PEP-S\r\n\r\n        Inclusion Criteria:\r\n\r\n          1. Spontaneous pregnancy in women above 18 years of age.\r\n\r\n          2. Gestational age of singleton pregnancy below full eight weeks by first transvaginal\r\n             ultrasound.\r\n\r\n          3. Ability to understand read and write Danish for the informed consent.\r\n\r\n          4. Planned delivery at the hospitals involved in the project.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. All types of ART treatment in the actual pregnancy.\r\n\r\n          2. Abnormal uterine anatomy or function already known or estimated at first transvaginal\r\n             ultrasonography.\r\n\r\n          3. History of recurrent pregnancy loss.\r\n\r\n          4. Ongoing or former (at least 12 months of no use) narcotics or alcohol abuse (above 14\r\n             units of alcohol per week).\r\n\r\n          5. Contraindication for pregnancy.\r\n      ","sponsor":"Nordsjaellands Hospital","sponsor_type":"Other","conditions":"Luteal Phase|Biomarkers|Abortion, Spontaneous|Abortion, Habitual|Pregnancy","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"PIF in PEP-A","time_frame":"During 2018","description":"Serum PIF by gestational age in the luteal phase"},{"outcome_type":"primary","measure":"Prediction model for the risk of spontaneous abortion","time_frame":"During 2018","description":"The ability of serum PIF to predict viability of natural pregnancies with and without other biomarkers, ultrasonographys and medical history data."},{"outcome_type":"primary","measure":"PIF and recurrent pregnancy loss (RPL)","time_frame":"Late 2018","description":"Serum PIF levels in a unique retrospective cohort of RPL patients"},{"outcome_type":"secondary","measure":"Hormonal development in the luteal phase","time_frame":"During 2018","description":"Descriptive overview of natural hormones in the luteal phase and their ability to predict pregnancy and live birth rates"},{"outcome_type":"other","measure":"Research biobank for future use","time_frame":"During 2017","description":"Establishment of a robust research biobank for future studies in blood derived conditions in the first trimester of pregnancy"}]}
{"nct_id":"NCT02770703","start_date":"2016-04-30","phase":"N/A","enrollment":60,"brief_title":"Mesh Position and Outcomes Following Inguinal Hernia Repair Using an MRI Visible Hernia Mesh","official_title":"Mesh Position and Outcomes Following Open (Lichtenstein), Endoscopic (TEP) and Laparoscopic (TAPP) Inguinal Hernia Repair Using a MRI Visible Hernia Mesh","primary_completion_date":"2019-03-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-03-31","last_update":"2018-08-15","description":"Inguinal hernia repair can be considered as one of the most frequent surgeries in general surgery worldwide. Surgical hernia repair procedures can generally be divided into minimally invasive (TEP, TAPP) and open techniques (e.g. Lichtenstein) and are equivalent with some advantages and disadvantages. The posterior wall of the inguinal channel is usually reinforced by a synthetic mesh, while non-mesh based surgeries have been steadily abandoned. Two of the most frequent complications following hernia surgery are hernia recurrence and chronic groin pain. Latter can occur in up to 10%. Both represent a considerable socio-economic impact. While different surgical hernia procedures and mesh fixation techniques have been evaluated as influential factors, the impact of mesh position and mesh deformation on hernia recurrence and chronic groin pain is unknown. This may be even more important, since endoscopic and laparoscopic hernia surgery procedures (TEP, TAPP) carry the risk of suboptimal mesh positioning, due to the final steps at the end of the surgery, where the mesh position is not under direct visual control. Until now direct mesh visualization was impossible. A recent development of MRI visible meshes (DynaMesh visible) provides the opportunity to evaluate mesh position and deformation after hernia surgery. In case of suspicious clinical hernia recurrence or postoperative chronic groin pain the mesh position can now directly be identified with Magnetic Resonance (MR) imaging preventing unnecessary explorative surgery. In this study the investigators plan to perform MRI scans to assess mesh position and deformation 90 days postoperatively and correlate it with the clinical status and pain score (VAS) of the patient. In order to allow for an optimal comparison of the post-operative mesh position in relation to the operative technique, patients will be randomized to minimally invasive (TEP, TAPP) and open techniques (e.g. Lichtenstein). To the investigators knowledge this is the first study investigating the impact of the three most common surgical hernia procedures on postoperative mesh position and deformation and its correlation to the clinical findings focussing on hernia recurrence and chronic groin pain.","other_id":"BASEC 2016-00085","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"Male","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male patients with a primary symptomatic unilateral inguinal hernia.\r\n\r\n          -  Patients eligible to undergo hernia repair either by minimally invasive (TEP, TAPP) or\r\n             open techniques (e.g. Lichtenstein) as judged by the treating surgeon\r\n\r\n          -  Written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Previous inguinal hernia repair\r\n\r\n          -  Bilateral inguinal hernia\r\n\r\n          -  Femoral hernia repair\r\n\r\n          -  Repair in local anesthetics,\r\n\r\n          -  Previous abdominal surgery\r\n\r\n          -  Children\r\n\r\n          -  Emergency surgery, e.g. incarcerated hernias\r\n\r\n          -  Contraindication for MRI scans (e.g. Pacemakers and similar implants, cochlea\r\n             implants, claustrophobia)\r\n\r\n          -  Contraindications to usage of mesh e.g. known hypersensitivity or allergy\r\n\r\n          -  Women who are pregnant or breast feeding\r\n\r\n          -  Inability to follow the procedures of the study, e.g. due to language problems,\r\n             psychological disorders, dementia\r\n\r\n          -  American Society of Anesthesiologists (ASA) classification higher or equal to 3\r\n      ","sponsor":"University Hospital, Basel, Switzerland","sponsor_type":"Other","conditions":"Unilateral Simple Inguinal Hernia","interventions":[{"intervention_type":"Device","name":"Device: DynaMesh visible mesh","description":"Implantation of a MRI visible mesh"}],"outcomes":[{"outcome_type":"primary","measure":"Evaluation of Mesh Position per MRI","time_frame":"90 days postoperatively"},{"outcome_type":"secondary","measure":"Evaluation of Mesh Deformation per MRI","time_frame":"90 days postoperatively"},{"outcome_type":"secondary","measure":"Groin pain using visual analogue scale","time_frame":"0, 1, 90, 365 days postoperatively"},{"outcome_type":"secondary","measure":"Recurrence of hernia","time_frame":"0, 1, 90, 365 days postoperatively"}]}
{"nct_id":"NCT02974985","start_date":"2016-04-30","phase":"N/A","enrollment":20,"brief_title":"A Study of the Lifting Capacity of Fillers","official_title":"A Study of the Lifting Capacity of Fillers","primary_completion_date":"2018-09-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2020-03-31","last_update":"2018-07-10","description":"Hyaluronic acid (HA) fillers are tested in-vitro to measure their lifting capacity, viscosity, cohesivity, and rheologic properties, and their lifting capacity has been tested in animal models. To date, there are no studies that measure the lifting capacity of fillers in an in-vivo human model. The intention is to study the lifting capacity of fillers in a group of patients by comparing pre and post-procedure two and three-dimensional photographs using analytic software. Specifically, the PI is interested in determining the amount of tissue elevation created by injecting HAs Restylane-Lyft, and Restylane-L (Galderma Laboratories, L.P., Fort Worth, TX) to the midface and to the lower face, both in the anterior-posterior direction and in the vertical direction by using analytic software. The research group has identified a reliable and reproducible quantitative assessment of midfacial position called WIZDOM (Width of the InterZygomatic Distance Of the Midface) to quantitatively evaluate the midface. It can be used as an objective tool to assess midfacial rejuvenation, whether with fat, fillers, or midface or facelift surgery. The Distance from WIZDOM to inner canthus, the WIZDOM -IC measurement increases with aging as the face deflates and descends, and, in the practice, is also a means of assessing the midface in youth and in aging. The PI's findings have been published in the Aesthetic Surgery Journal. The practice will also attempt to utilize this metric as a measure of midface aesthetic lifting capacity. The practice will also employ 3 D photography and analytic software to determine degree of lift in mm in the y and z axis. (vertical and AP increase in dimension) pre and post- injection. (Vectra, Canfield, Fairfield, NJ) We will recruit patients from a population of subjects that generally would receive fillers to improve changes associated with facial volume loss and divide them in to two groups based on chronologic age.","other_id":"16-023","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":40,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Women ages 40-60\r\n\r\n          -  Midface, lower face volume loss and gravitational changes amenable to the\r\n             administration of HA fillers.\r\n\r\n          -  Filler requirements, based on experienced injector assessment, on the order of 8\r\n             syringes.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of prior filler injections in the past 12 months.\r\n\r\n          -  Pregnancy/planned pregnancy\r\n\r\n          -  Allergy to HA products\r\n      ","sponsor":"Abington Memorial Hospital","sponsor_type":"Other","conditions":"Esthetic & Topographic Shifts From Facial Fillers","interventions":[{"intervention_type":"Device","name":"Device: injection of Restylane Lyft and Restylane L","description":"Intervention--Injections of volumizing products to the midface, nasolabial fold, and marionette folds in female patients in two different age groups"}],"outcomes":[{"outcome_type":"primary","measure":"Degree and axes of volume shifts before and after injection of HA fillers","time_frame":"immediately after injection","description":"The investigators are using Vectra analysis software to analyze volume changes in 3D. dimensions after injection of hyaluronic acid filler."},{"outcome_type":"secondary","measure":"Measurement of MMVS","time_frame":"Two weeks post injections.","description":"Medicis Midface Volume Scale"},{"outcome_type":"secondary","measure":"Patient and Observer Satisfaction with Degree of Lift","time_frame":"immediately after injection","description":"Change in global aesthetic assessment measured from baseline."},{"outcome_type":"secondary","measure":"Measure the capacity of fillers in the midface to change midface position.","time_frame":"immediately after injection","description":"H1 and Vectra analytic software: movement of measured points of reference on the face."},{"outcome_type":"secondary","measure":"Measure the capacity of fillers in the midface to improve relationship between eyelid and cheek.","time_frame":"immediately after injection","description":"WIZDOM measurement and WIZDOM -IC measurement"},{"outcome_type":"secondary","measure":"Measure the capacity of fillers in the midface to change lower face position.","time_frame":"immediately after injection","description":"H1 and Vectra analytic software: movement of measured points of reference on the face."},{"outcome_type":"secondary","measure":"Patient-reported subjective assessment of filler effect and satisfaction","time_frame":"Two weeks post injections.","description":"GAIS Scale"},{"outcome_type":"secondary","measure":"Investigator assessment of filler effect.","time_frame":"Two weeks post injections.","description":"GAIS scale"}]}
{"nct_id":"NCT02742948","start_date":"2016-04-30","phase":"Phase 2","enrollment":600,"brief_title":"The Optimal Time for Intravenous Antibiotic Prophylaxis in Elective Cesarean Section","official_title":"The Optimal Time for Intravenous Antibiotic Prophylaxis in Elective Cesarean Section: Randomized Comparative Study","primary_completion_date":"2016-08-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2016-09-30","last_update":"2016-04-19","description":"Objective: To determine the optimal time for intravenous antibiotic prophylaxis administration in pregnant women undergoing elective cesarean section to minimize postpartum infectious complication for both the mother & neonate. Study Design: A randomized comparative study. Setting: The Obstetrics and Gynecology department of Kasr El Aini hospital (Cairo University - Egypt) in the period from April 2016 to September 2016. Methodology: Six hundred pregnant women aged from 20 to 40 years old with singleton living healthy fetuses undergoing elective lower segment caesarean section (LSCS).They will be randomized into three groups: group A in which 200 women will receive IV ceftriaxone (2g) 60 minutes before skin incision, group B in which 200 women will receive IV ceftriaxone (2g) immediately with skin incision & group C in which 200 women will receive IV ceftriaxone (2g) immediately after umbilical cord clamping. Outcomes include postoperative maternal & fetal infectious morbidity.","other_id":"821978","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"Female","minimum_age":20,"maximum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  pregnant women in singleton living healthy fetuses. gestational age (GA) more than 37\r\n             weeks gestation\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients on immunosuppressant drugs, received any antibiotic prophylaxis (within 10\r\n             days), suffer any chronic illness (e.g. diabetes mellitus or renal disease) or who\r\n             experienced any obstetric complication in the current pregnancy (e.g. antepartum\r\n             hemorrhage & rupture of membranes). Previous history of more than two laparotomies,\r\n             maternal BMI more than 28 & any maternal febrile illness within 10 days from the\r\n             procedure. Patients who are known to be allergic to penicillin or cephalosporin\r\n      ","sponsor":"Cairo University","sponsor_type":"Other","conditions":"Endometritis","interventions":[{"intervention_type":"Drug","name":"Drug: ceftriaxone","description":"IV ceftriaxone (2g) will be given to all participants"}],"outcomes":[{"outcome_type":"primary","measure":"endometritis","time_frame":"up to 4 weeks postoperative","description":"maternal axillary temperature ≥ 38°C for at least 48 hours, uterine tenderness, infected lochia & leukocytosis."},{"outcome_type":"secondary","measure":"neonatal immediate side effects","time_frame":"within 24 hours postoperative","description":"diarrhea & fever"},{"outcome_type":"secondary","measure":"neonatal sepsis","time_frame":"up to 1 week postoperative","description":"clinical signs, leukocytosis, CRP & positive blood culture"},{"outcome_type":"secondary","measure":"neonatal ICU admission","time_frame":"within 24 hours postoperative"},{"outcome_type":"secondary","measure":"Prolonged hospital stay","time_frame":"2 days"},{"outcome_type":"secondary","measure":"wound infection","time_frame":"up to 4 weeks postoperative","description":"induration, redness, hematoma, seroma or purulent discharge at the incision site"},{"outcome_type":"secondary","measure":"urinary tract infection","time_frame":"up to 4 weeks postoperative","description":"frequency, dysuria, suprapubic or loin pain & positive urine culture."}]}
{"nct_id":"NCT02752087","start_date":"2016-04-30","phase":"Phase 1","enrollment":24,"brief_title":"A Study to Compare the Effects of a Test and Reference Formulation of LY900014 in Healthy Participants","official_title":"A Study to Compare the Pharmacokinetics and Pharmacodynamics of LY900014 Test Versus Reference Formulations in Healthy Subjects","primary_completion_date":"2016-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-05-31","last_update":"2020-05-01","description":"This study of healthy participants evaluated the concentration of a test LY900014 and a reference LY900014 formulation in the bloodstream and how it affected the blood sugar levels. The whole study, including screening, took up to 8 weeks to complete.","other_id":"16489","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":21,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Female participants who can potentially get pregnant:\r\n\r\n               -  Must have a negative pregnancy test at the time of screening\r\n\r\n               -  Agree to continue to use a reliable method of birth control until the end of the\r\n                  study\r\n\r\n          -  Have a body mass index (BMI) of 18.0 to 30.0 kilogram per meter square (kg/m),\r\n             inclusive, at screening\r\n\r\n          -  Are nonsmokers, have not smoked for at least 2 months before entering the study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Are currently enrolled in a clinical trial involving an investigational product or any\r\n             other type of medical research judged not to be scientifically or medically compatible\r\n             with this study\r\n\r\n          -  Have known allergies to insulin lispro, related compounds, or any components of the\r\n             formulation\r\n\r\n          -  Have significant history of or current cardiovascular, respiratory, hepatic, renal,\r\n             gastrointestinal, endocrine, hematological, or neurological disorders capable of\r\n             significantly altering the absorption, metabolism, or elimination of drugs\r\n\r\n          -  Intend to use over-the-counter or prescription medication within 7 and 14 days,\r\n             respectively, before dosing (apart from vitamin/mineral supplements, occasional\r\n             paracetamol, hormonal contraception, or thyroid-replacement therapy)\r\n\r\n          -  Have used systemic glucocorticoids within 3 months prior to entry into the study\r\n\r\n          -  Have donated blood of more than 450 milliliters (mL) or more in the last 3 months or\r\n             provided any blood donation within the last month before screening\r\n      ","sponsor":"Eli Lilly and Company","sponsor_type":"Industry","conditions":"Healthy","interventions":[{"intervention_type":"Drug","name":"Drug: LY900014","description":"Administered SC"}],"outcomes":[{"outcome_type":"primary","measure":"Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC[0-8 Hours])","time_frame":"5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, and 480 minutes post study dose for each treatment","description":"PK: Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC[0-8 Hours])"},{"outcome_type":"secondary","measure":"Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot)","time_frame":"Blood glucose was measured approximately every 2.5 minutes for the first 30 minutes, then every 5 minutes until 120 minutes post dose, and then every 10 minutes until 480 minutes post dose","description":"Gtot is the total glucose infusion over the clamp duration. It is used to measure the study drug action over time as measured by the euglycemic clamp procedure."}]}
{"nct_id":"NCT03093896","start_date":"2016-04-30","phase":"N/A","enrollment":60,"brief_title":"The Effect of Consumption of Almonds and Snack Mix Daily for 6 Months on Cognitive Function in Older Adults","official_title":"The Effect of Consumption of Almonds and Snack Mix Daily for 6 Months on Performance on a Battery of Computerized Cognitive Tests (CANTAB) in Older Adults","primary_completion_date":"2018-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-05-31","last_update":"2020-03-20","description":"Cognitive impairment is also a major risk factor for development of dementia later in life. Findings from recent studies suggest that the there are many nutrients contained in foods that may be important in cognitive function in the elderly. This study evaluates long-term intervention with almonds and snack mix as a treatment strategy for age-related cognitive impairment which could possibly prevent the onset of dementia. The proposed study is designed as a randomized, placebo controlled trial that tests the effects of 6 month supplementation with 1.5 or 3 ounces of almonds or 3 ounces of shortbread containing coconut oil on cognitive function in older adults. Secondary outcomes include plasma biomarkers of oxidative stress and inflammation.","other_id":"003","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":50,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  men and women age >50 - 75 years\r\n\r\n          -  body mass index >25-35 kg/m2\r\n\r\n          -  Mini mental state exam (MMSE) score >24\r\n\r\n          -  must be able to give written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  history of active small bowel disease or resection\r\n\r\n          -  atrophic gastritis\r\n\r\n          -  uncontrolled blood pressure or untreated hypertension alcoholism (>2 drinks/d or 14\r\n             drinks/week)\r\n\r\n          -  abnormal hematologic parameters that are determined by the study MD to influence study\r\n             outcomes.\r\n\r\n          -  endocrine disorders including diabetes or current pharmacological treatment of\r\n             diabetes and untreated thyroid disease\r\n\r\n          -  pancreatic disease\r\n\r\n          -  anemia, and bleeding disorders\r\n\r\n          -  nut allergy\r\n\r\n          -  major chronic illness that might interfere with the study outcomes\r\n\r\n          -  active cancer except for prostate cancer or cancer-free for at least 5 years\r\n\r\n          -  unwilling to not use lutein, n3 fatty acid, or choline supplements for 2 months prior\r\n             to study start\r\n\r\n          -  diseases that interfere with fat absorption, e.g. colitis, celiac disease, Crohn's\r\n             disease, cystic fibrosis (as determined by screening interview)\r\n\r\n          -  rheumatologic diseases including gout or inflammatory arthritis\r\n\r\n          -  immune deficiency conditions including autoimmune dieases, human immune deficiency\r\n             virus (HIV); history of organ transplantation\r\n\r\n          -  medications that interfere with fat absorption, e.g. bile sequestrants (as determined\r\n             by screening interview)\r\n\r\n          -  use of antipsychotic, antimanic, anti-inflammatory (except for aspirin and non\r\n             steroidal anti-inflammatory drugs[NSAIDS]), monoamine inhibitors, or dementia\r\n             medications\r\n\r\n          -  inability to discontinue aspirin, NSAIDS for 72 hours prior to and for the duration of\r\n             testing at study visits (baseline, 3 and 6 months)\r\n\r\n          -  daily intake of proton pump inhibitors or H2 blockers\r\n\r\n          -  smoking or use of nicotine patches or gum (within past 6 months)\r\n\r\n          -  use of drugs suspected of interfering with metabolism of blood clotting with the\r\n             exception of aspirin and NSAIDS, e.g. warfarin (as determined by screening interview)\r\n\r\n          -  stroke, head injury with loss of consciousness or seizures.\r\n\r\n          -  history or clinical manifestation of any significant neurologic disorder in the\r\n             opinion of the investigator.\r\n      ","sponsor":"Tufts University","sponsor_type":"Other","conditions":"Mild Cognitive Impairment","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: almonds, 3 oz","description":"almonds, 3.0 oz/day"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: snack mix","description":"commercial cereal mix with bits of beef jerky and coconut"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: almonds, 1.5 oz","description":"almonds, 1.5 oz/day"}],"outcomes":[{"outcome_type":"primary","measure":"executive function executive function assessed by test administered via CANTAB (www.cambridgecognition.com)","time_frame":"change from baseline executive function at 6 months","description":"tests administered via CANTAB (www.cambridgecognition.com)"},{"outcome_type":"secondary","measure":"attention assessed by test administered via CANTAB (www.cambridgecognition.com)","time_frame":"change from baseline attention at 6 months","description":"test administered via CANTAB (www.cambridgecognition.com)"},{"outcome_type":"secondary","measure":"visual memory assessed by test administered via CANTAB (www.cambridgecognition.com)","time_frame":"change from baseline visual memory at 6 months","description":"test administered via CANTAB (www.cambridgecognition.com)"},{"outcome_type":"secondary","measure":"inflammation - serum C-reactive protein as measured by ELISA kit","time_frame":"change from baseline serum CRP concentration at 6 months","description":"serum C-reactive protein - ELISA kit"},{"outcome_type":"secondary","measure":"inflammation - serum IL6 as measured by ELISA kit","time_frame":"change from baseline serum IL-6 concentration at 6 months","description":"serum IL-6 - ELISA kit"},{"outcome_type":"secondary","measure":"inflammation - serum IL12 as measured by ELISA kit","time_frame":"change from baseline serum IL-12 concentration at 6 months","description":"serum IL12 - ELISA kit"},{"outcome_type":"secondary","measure":"inflammation - serum ICAM as measured by ELISA kit","time_frame":"change from baseline serum ICAM concentration at 6 months","description":"serum ICAM - ELISA kit"},{"outcome_type":"secondary","measure":"plasma fatty acids","time_frame":"change from baseline plasma fatty acids concentration at 6 months","description":"measured by gas chromatography"},{"outcome_type":"secondary","measure":"plasma alpha-tocopherol","time_frame":"change from baseline plasma alpha-tocopherol concentration at 6 months","description":"measured by high pressure liquid chromatography"},{"outcome_type":"secondary","measure":"plasma magnesium","time_frame":"change from baseline plasma magnesium concentration at 6 months","description":"measured by atomic emission spectroscopy"},{"outcome_type":"secondary","measure":"fatty acids in red blood cells","time_frame":"change from baseline fatty acids concentration in red blood cells at 6 months","description":"measured by gas chromatography/mass spectroscopy"},{"outcome_type":"secondary","measure":"oxidative stress - aminothiols","time_frame":"change from baseline serum aminothiols at 6 months","description":"serum aminothiols - HPLC"},{"outcome_type":"secondary","measure":"oxidative stress - isoprostanes","time_frame":"change from baseline urinary isoprostanes at 6 months","description":"urinary isoprostanes - spectrophotometer"},{"outcome_type":"secondary","measure":"oxidative stress - superoxide dismutase","time_frame":"change from baseline serum superoxide dismutase at 6 months","description":"serum superoxide dismutase - ELISA kit"},{"outcome_type":"secondary","measure":"oxidative stress - glutathione peroxidase","time_frame":"change from baseline serum glutathione peroxidase at 6 months","description":"serum glutathione peroxidase - ELISA kit"},{"outcome_type":"secondary","measure":"oxidative stress - glutathione reductase","time_frame":"change from baseline serum glutathione reductase at 6 months","description":"serum glutathione reductase - ELISA kti"},{"outcome_type":"secondary","measure":"total serum cholesterol","time_frame":"change from baseline total serum cholesterol at 6 months","description":"colormetric assay Beckman Coulter AU400"},{"outcome_type":"secondary","measure":"serum low density lipoprotein","time_frame":"change from baseline serum low density lipoprotein at 6 months","description":"colormetric assay Beckman Coulter AU400"},{"outcome_type":"secondary","measure":"serum high density lipoprotein","time_frame":"change from baseline serum high density lipoprotein at 6 months","description":"colormetric assay Beckman Coulter AU400"},{"outcome_type":"secondary","measure":"serum very low density lipoprotein","time_frame":"change from baseline serum very low density lipoprotein at 6 months","description":"colormetric assay Beckman Coulter AU400"}]}
{"nct_id":"NCT02735317","start_date":"2016-04-30","phase":"Phase 2","enrollment":90,"brief_title":"Efficacy and Safety of FORRAD for the Management of Radiation-induced Mucositis in Patients With Nasopharyngeal Carcinoma Receiving IMRT","official_title":"Efficacy and Safety of FORRAD for the Management of Radiation-induced Mucositis in Patients With Nasopharyngeal Carcinoma Receiving IMRT: A Single-center, Randomized Controlled Trial","primary_completion_date":"2017-06-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2017-06-30","last_update":"2016-04-12","description":"Radiation therapy remains the principal treatment for nasopharyngeal carcinoma (NPC). The most frequently occurred radiation-related side effect is probably the radiation-induced oral mucositis (OM), which affects up to 100% of NPC patients receiving radiation therapy. When severe, oral mucositis increases the risk of infection and may compromise clinical outcomes by necessitating treatment breaks, dosage reductions, and reduced therapy compliance. In China, a quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and procaine, is commonly prescribed when NPC patients begin to suffer from radiation-induced OM. However, the incidence of radiation-induced OM is still quite high. Oral Ulcer Gargle (FORRAD) is a proprietary viscous liquid mucoadhesive hydrogel formulation. It creates a palliative barrier over injured mucosa, to prevent and to cure radiation-induced OM. The objective of this randomized phase II study is to assess the efficacy and safety of Oral Ulcer Gargle (FORRAD) as an intervention for radiation-induced OM in the treatment of NPC, compared with the commonly used quadruple mixture, which is composed of dexamethasone, gentamicin, vitamin B12, and procaine.","other_id":"B2015-074-01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Pathologically confirmed and previously untreated nasopharyngeal carcinoma.\r\n\r\n          2. Age  18 years and  65 years.\r\n\r\n          3. Karnofsky performance status (KPS) score  70.\r\n\r\n          4. Planned to receive radiotherapy alone or concurrent chemoradiotherapy, with\r\n             intensity-modulated radiation therapy (IMRT).\r\n\r\n          5. Adequate bone marrow function: while blood cell >= 3,000/L, absolute neutrophil count\r\n             >= 1,500/L, hemoglobin >= 100g/L, platelet >= 75,000/L.\r\n\r\n          6. Life expectancy of >= 3 months.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Known allergic reaction to any component of Oral Ulcer Gargle (FORRAD) or quadruple\r\n             mixture, which is composed of dexamethasone, gentamicin, vitamin B12, and procaine, or\r\n             severe allergic constitution.\r\n\r\n          2. Other conditions that the investigators consider as inappropriate for enrolling into\r\n             this study.\r\n      ","sponsor":"Yun-fei Xia","sponsor_type":"Other","conditions":"Nasopharyngeal Neoplasms|Stomatitis","interventions":[{"intervention_type":"Drug","name":"Drug: Oral Ulcer Gargle (FORRAD)","description":"Oral Ulcer Gargle (FORRAD) is prescribed at the beginning of radiotherapy for free. Patients are asked to start application of Oral Ulcer Gargle (FORRAD) at the onset of radiotherapy, four times a day (after meals and before bedtime), until completion of their radiotherapy. All patients will receive conventional health education and medical care for prevention and treatment of radiation-induced oral mucositis. When grade > 3 OM happened, other interventions, such as prophylactic or therapeutic antibacterial therapy, will be used, and radiotherapy should be interrupted."},{"intervention_type":"Drug","name":"Drug: Quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and procaine","description":"Quadruple mixture is prescribed at the beginning of radiotherapy. Patients are asked to start application of quadruple mixture at the onset of radiotherapy, four times a day (before meals and before bedtime), until completion of their radiotherapy. All patients will receive conventional health education and medical care for prevention and treatment of radiation-induced oral mucositis. When grade > 3 OM happened, other interventions, such as prophylactic or therapeutic antibacterial therapy, will be used, and radiotherapy should be interrupted."}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of grade ≥ 3 mucositis","time_frame":"Day 56 after completion or termination of radiotherapy","description":"Incidence of grade ≥ 3 mucositis according to CTCAE version 4.0"},{"outcome_type":"primary","measure":"OMAS","time_frame":"Day 56 after completion or termination of radiotherapy","description":"Oral Mucositis Assessment Scale (OMAS) provides an objective assessment of oral mucositis based on assessment of the appearance and extent of redness and ulceration in various areas of the mouth."},{"outcome_type":"primary","measure":"OMDQ MTS question 2 (Q2) score","time_frame":"Day 56 after completion or termination of radiotherapy","description":"Oral Mucositis Daily Questionnaire (OMDQ) mouth and throat soreness (MTS) question 2 (Q2) is a 5-point categorical scale in which patients grade MTS from 0 (no soreness) to 4 (extreme soreness)3 which is a component of the OMDQ in that it tracks very well with objective (WHO score and opioid use) and subjective measurement of OM severity."},{"outcome_type":"primary","measure":"WHO score","time_frame":"Day 56 after completion or termination of radiotherapy","description":"The World Health Organization (WHO) Oral Toxicity score combines both elements into a single score that grades the severity of the condition from 0 (no oral mucositis) to 4 (swallowing not possible such that patient needs supplementary nutrition)."},{"outcome_type":"primary","measure":"EORTC QLQ-C30","time_frame":"Day 56 after completion or termination of radiotherapy","description":"EORTC QLQ-C30 is a Quality-of-Life Instrument proposed by the European Organization for Research and Treatment of Cancer (EORTC), for use in International Clinical Trials in Oncology. The QLQ-C30 incorporates nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale."},{"outcome_type":"secondary","measure":"Interruption time during the schedule of radiotherapy","time_frame":"Through radiotherapy completion or termination, an average of 7 weeks","description":"The cumulative interruption time during the schedule of radiotherapy because of grade 4 or higher radiation-induced oral mucositis."},{"outcome_type":"secondary","measure":"Time for healing of radiation-induced oral mucositis","time_frame":"Through study completion, an average of 15 weeks","description":"Time until healing of radiation-induced oral mucositis, after the completion or the termination of radiotherapy."},{"outcome_type":"secondary","measure":"The cumulative dose of opioid used","time_frame":"Through study completion, an average of 15 weeks","description":"The cumulative dose of opioid used from the beginning of radiotherapy until the completion of study."},{"outcome_type":"secondary","measure":"The cumulative time using opioid","time_frame":"Through study completion, an average of 15 weeks","description":"The cumulative time using opioid from the beginning of radiotherapy until the completion of study."},{"outcome_type":"secondary","measure":"The change of body weight from baseline.","time_frame":"Baseline and 7 weeks","description":"The change of body weight before radiotherapy and the day when radiotherapy is completed or terminated."}]}
{"nct_id":"NCT02710721","start_date":"2016-04-30","phase":"N/A","enrollment":60,"brief_title":"Fasting and Nutritional Therapy in Patients With Advanced Metastatic Prostate Cancer","official_title":"Clinical Study on the Efficacy of Fasting and Nutritional Therapy as a Complementary Treatment of Advanced Metastatic Prostate Cancer Undergoing Chemotherapy - an Exploratory Randomized Controlled Trial","primary_completion_date":"2020-07-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2021-12-31","last_update":"2021-02-03","description":"The aim of this trial is a first evaluation of the effectiveness of intermittent fasting as a supplementary therapy in patients with CRPC or hormone-sensitive prostate cancer with high metastatic load (1 visceral and 4 osseous metastases) in respect to quality of life, reduction of side effects and possible reduction in tumor progression.","other_id":"ProstateDiet","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":25,"maximum_age":89,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosis of CRPC or hormone-sensitive prostate cancer with high metastatic load\r\n\r\n          -  Cancer is treated to guidelines conventionally with chemotherapy or with a combination\r\n             of hormone therapy and chemotherapy.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Underweight (BMI <20 kg/m2) or actual weight decrease >2 kg or >5 kg in the last 1 or\r\n             3 months.\r\n\r\n          -  Eating disorder\r\n\r\n          -  Dementia\r\n\r\n          -  Psychosis\r\n\r\n          -  Terminal illness with a significant limitation of mobility and overall vitality\r\n\r\n          -  Diabetes mellitus type 1\r\n\r\n          -  Renal insufficiency stage > 2, GFR <60mlmin / 1.73 m2\r\n      ","sponsor":"Charite University, Berlin, Germany","sponsor_type":"Other","conditions":"Fasting|Prostatic Neoplasms","interventions":[{"intervention_type":"Other","name":"Other: Fasting","description":"Patients realize a 60h-modified fasting (36h before and 24h after chemotherapy) with a dietary energy supply 350-400kcal per day with fruit and vegetable juices or, if not feasible, an established fasting-mimicking diet of 600-800 kcal according to Longo et al. Between chemotherapy a Mediterranean diet with nutrition training individually and in small groups by trained nutritionists at the Study Centre will be practiced."},{"intervention_type":"Other","name":"Other: Control","description":"Participants of the control group will receive an individual nutrition training and in small groups according to the Mediterranean diet."}],"outcomes":[{"outcome_type":"primary","measure":"FACT-P/-Taxane/-An sum score","time_frame":"Assessment day 0 (baseline) and 7 days after each of 6 chemotherapies (study weeks 1,4,7,10,13,16)","description":"summarized change of FACT score from baseline to day 8 after each chemotherapy"},{"outcome_type":"secondary","measure":"FACT-P/-Taxane/-An sum score","time_frame":"Assessment day 0 (baseline) and 3 and 6 months after day 0","description":"Change of score after 3 and 6 months"},{"outcome_type":"secondary","measure":"HADS","time_frame":"Assessment day 0 (baseline) and 7 days after each of 6 chemotherapies (study weeks 1,4,7,10,13,16) and after 3 and 6 months after study day 0","description":"Summarized change of score for all time Points"},{"outcome_type":"other","measure":"Differential blood count","time_frame":"Assessment day 0 (baseline) and 7 days after each of 6 chemotherapies (study weeks 1,4,7,10,13,16) and after 3 and 6 months after study day 0","description":"Summarized changes of blood count"},{"outcome_type":"other","measure":"Intensity of chemotherapy- related side effects","time_frame":"Assessment day 0 (baseline) and 7 days after each of 6 chemotherapies (study weeks 1,4,7,10,13,16)","description":"Group difference of summarized frequency and intensity"}]}
{"nct_id":"NCT02753205","start_date":"2016-04-30","phase":"N/A","enrollment":0,"brief_title":"Dexmedetomidine on Optic Nerve Sheath Diameter","official_title":"Effect of Dexmedetomidine on Optic Nerve Sheath Diameter During Laparoscopic Anterior Resection","primary_completion_date":"2018-04-30","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2018-04-30","last_update":"2016-11-10","description":"Dexmedetomidine, might attenuate the sympathetic activation and contribute to stable hemodynamics. The investigator hypothesized that continuous infusion of dexmedetomidine during laparoscopic lower abdominal surgery, might help to attenuate the increment of intracranial pressure and the investigator would observe the optic nerve sheath diameter using ultrasonography.","other_id":"GCIRB2016-058","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  clinical diagnosis of colorectal cancer\r\n\r\n          -  planed for laparoscopic low anterior resection\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  morbid obesity (body mass index > 30 kg.m-2)\r\n\r\n          -  history of cerebrovascular disease\r\n\r\n          -  history of respiratory disease\r\n\r\n          -  uncontrolled cardiovascular disease\r\n      ","sponsor":"Gachon University Gil Medical Center","sponsor_type":"Other","conditions":"Intracranial Hypertension","interventions":[{"intervention_type":"Drug","name":"Drug: Dexmedetomidine","description":"infusion of dexmedetomidine 0.5ug/kg/h for 10 min and after that, infusion of dexmedetomidine 0.4ug/kg/h until the end of surgery"},{"intervention_type":"Drug","name":"Drug: normal saline","description":"infusion of normal saline"}],"outcomes":[{"outcome_type":"primary","measure":"Optic nerve sheath diameter","time_frame":"Change from Baseline optic nerve sheath diameter at pneumoperitoneum 30 min","description":"mm"},{"outcome_type":"secondary","measure":"Respiratory and mean arterial pressure","time_frame":"Change from Baseline Respiratory and mean arterial pressure at pneumoperitoneum 30 min","description":"mmHg"}]}
{"nct_id":"NCT02770794","start_date":"2016-04-01","phase":"Phase 4","enrollment":211,"brief_title":"Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis","official_title":"Multicenter Prospective Trial to Investigate Accuracy of Ultrasound to Predict Relapse After Discontinuation of Infliximab and Efficacy/Safety of Readministration of Infliximab in Patients With Rheumatoid Arthritis in Low Disease Activity","primary_completion_date":"2020-08-14","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-08-14","last_update":"2021-01-20","description":"This multicenter prospective clinical trial investigates the accuracy of ultrasound to predict relapse after discontinuation of infliximab and the efficacy/safety of readministration of infliximab in patients with rheumatoid arthritis in a low disease activity state.","other_id":"137","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. 18 years or older\r\n\r\n          2. RA patients who fulfill 2010 ACR/EULAR Classification Criteria\r\n\r\n          3. Patients who have been treated with infliximab (Remicade) for 26 weeks or longer\r\n\r\n          4. DAS28 (CRP) < 3.2 at screening\r\n\r\n          5. Patients who give written informed consent after receiving sufficient information -\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Receiving prednisolone > 10 mg/day\r\n\r\n          2. Receiving biological or molecular-target anti-rheumatic drug\r\n\r\n          3. Alteration of the dose of corticosteroid or anti-rheumatic drug within 8 weeks prior\r\n             to screening visit\r\n\r\n          4. Alteration of the dose of non-steroid anti-inflammatory drug within 4 weeks prior to\r\n             screening visit\r\n\r\n          5. History of infusion reaction to infliximab\r\n\r\n          6. Current infection which requires treatment\r\n\r\n          7. Current or previous demyelinating disorder\r\n\r\n          8. Current congestive heart failure which requires treatment\r\n\r\n          9. Breast-feeding or pregnant/possibly pregnant woman, or woman who does not agree to\r\n             prevent conception during and 6 months after study period\r\n\r\n         10. Patients whom investigator or co-investigator consider inappropriate for other reasons\r\n             -\r\n      ","sponsor":"Chiba University","sponsor_type":"Other","conditions":"Arthritis, Rheumatoid","interventions":[{"intervention_type":"Drug","name":"Drug: Infliximab","description":"Discontinue infliximab; receive Infliximab when relapse"}],"outcomes":[{"outcome_type":"secondary","measure":"EULAR response criteria based on DAS28 after readministration of infliximab","time_frame":"12 week after relapse","description":"EULAR response criteria based on DAS28 at 12 week after relapse and readministration of infliximab"},{"outcome_type":"primary","measure":"Area under the Receiver Operator Characteristic (ROC) curve for total power Doppler score to predict relapse","time_frame":"48 week","description":"Area under the ROC curve for total power Doppler score at baseline to predict relapse within 48 weeks after discontinuation of infliximab"},{"outcome_type":"secondary","measure":"Area under the ROC curve for total gray-scale score to predict relapse","time_frame":"48 week","description":"Area under the ROC curve for total gray-scale score at baseline to predict relapse within 48 weeks after discontinuation of infliximab"},{"outcome_type":"secondary","measure":"Change in van der Heijde modified Sharp score","time_frame":"48 week","description":"Change in van der Heijde modified Sharp score at 48 week"},{"outcome_type":"secondary","measure":"Change in Health Assessment Questionnaire-Disability Index","time_frame":"48 week","description":"Change in Health Assessment Questionnaire-Disability Index at 48 week"},{"outcome_type":"secondary","measure":"Change in EuroQoL 5 dimensions-5L","time_frame":"48 week","description":"Change in EuroQoL 5 dimensions-5L at 48 week"},{"outcome_type":"secondary","measure":"Number of adverse events as assessed by CTCAE v4.0","time_frame":"Through study completion, an average of 60 weeks","description":"Number of adverse events as assessed by CTCAE v4.0 through study completion, an average of 60 weeks"}]}
{"nct_id":"NCT03360539","start_date":"2016-04-01","phase":"N/A","enrollment":5820,"brief_title":"Nurse-Family Partnership Impact Evaluation in South Carolina","official_title":"Nurse-Family Partnership Impact Evaluation in South Carolina","primary_completion_date":"2023-04-01","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2046-04-01","last_update":"2021-01-22","description":"This study evaluates the effects of the Nurse Family Partnership (NFP), an established home-visiting program, using a scientifically rigorous individual-level randomized controlled trial. The study will be based in South Carolina, where a Medicaid waiver in combination with a pay-for-success contract will allow expansion of the program to women on Medicaid. The study plans to enroll 4000 low-income, first time mothers and their children into the intervention group, and another 2000 into the control group. The study will evaluate the program's impacts on outcomes using administrative records. This study aims to yield new evidence on the effect of NFP in a modern context, applied to a new population, across a broad range of outcomes, and financed by a novel public-private partnership based on accountability for outcomes.","other_id":"IRB15-2939","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","intervention_model_description":"The Nurse-Family Partnership (NFP) was launched by pediatrician David Olds in the early 1970s in response to the observation that low-income mothers are less likely to engage in positive health and parenting behaviors that are associated with better child development outcomes (Olds et al. 1986). NFP is a prenatal and infancy home visiting program for low-income, first-time mothers and their families. Registered nurses begin visiting their clients as early in the pregnancy as possible, helping the mother-to-be make informed choices. The nurses continue visiting regularly until the child is two years old.","sampling_method":"","gender":"Female","minimum_age":15,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Female\r\n\r\n          -  No previous live births\r\n\r\n          -  Currently pregnant\r\n\r\n          -  Gestation period less than 28 weeks (i.e. less than or equal to 27 weeks, 6 days) at\r\n             time of recruitment\r\n\r\n          -  Ages 15-55\r\n\r\n          -  Income level meets Medicaid eligibility criteria\r\n\r\n          -  Live within an area serviced by a NFP Implementing Agency\r\n\r\n          -  Not currently enrolled in the study\r\n\r\n          -  Not incarcerated or living in lock down facilities\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Men\r\n\r\n          -  Women who have had a previous live birth\r\n\r\n          -  Women who are not currently pregnant\r\n\r\n          -  Women who are past their 28th week of gestation (i.e. greater than or equal to 28\r\n             weeks, 0 days) at time of recruitment\r\n\r\n          -  Women who are younger than 15 or older than 55 years of age\r\n\r\n          -  Women whose income level does not meet Medicaid eligibility criteria\r\n\r\n          -  Women who live outside of an area serviced by a NFP Implementing Agency\r\n\r\n          -  Women who are currently enrolled in the study\r\n\r\n          -  Women who are currently incarcerated or living in a lock down facility\r\n      ","sponsor":"Harvard School of Public Health","sponsor_type":"Other","conditions":"Preterm Birth|Injuries|Maternal Behavior","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Nurse-Family Partnership"}],"outcomes":[{"outcome_type":"secondary","measure":"Perinatal mortality","time_frame":"1 month postpartum; mortality records and fetal death records","description":"Fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life"},{"outcome_type":"secondary","measure":"NICU admission of at least overnight","time_frame":"At birth; hospital discharge","description":"Infant admitted to the neonatal intensive care unit (NICU) for at least one night"},{"outcome_type":"secondary","measure":"Maternal experience of violence or homicide","time_frame":"24 months postpartum; Medicaid claims, mortality records","description":"Includes any ICD code for healthcare encounter associated with experiencing violence or mortality associated with homicide based on ICD code"},{"outcome_type":"secondary","measure":"Postpartum visit","time_frame":"12 weeks postpartum; Medicaid claims","description":"Postpartum visit in first 12 weeks after birth"},{"outcome_type":"secondary","measure":"Adequate prenatal care","time_frame":"At birth; vital records","description":"Adequacy of Prenatal Care Utilization Index (APNCU)"},{"outcome_type":"primary","measure":"Composite birth outcome","time_frame":"0-7 days after birth; vital records, mortality records, and fetal death records","description":"Composite of at least one of: small for gestational (SGA), or low birth weight (LBW) less than 2500 grams, preterm birth (PTB) less than 37 weeks' gestation (obstetric estimate), or perinatal mortality (fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life)"},{"outcome_type":"primary","measure":"Major injury or concern for abuse or neglect","time_frame":"24 months postpartum; Medicaid claims or hospital discharge data","description":"Composite of at least one health care encounter or mortality associated with ICD codes indicating either major injury, or, concern for abuse or neglect"},{"outcome_type":"primary","measure":"Inter-birth interval of < 21 months","time_frame":"21 months postpartum; vital records","description":"Having a subsequent birth within the first 21 months of the index birth"},{"outcome_type":"secondary","measure":"Small for gestational age (SGA)","time_frame":"At birth; vital records","description":"Infant birth weight below the 10th percentile for infants of the same gestational age"},{"outcome_type":"secondary","measure":"Large for gestational age (LGA)","time_frame":"At birth; vital records","description":"Infant birth weight above the 90th percentile for infants of the same gestational age"},{"outcome_type":"secondary","measure":"Low birth weight (LBW)","time_frame":"At birth; vital records","description":"Infant born with a birth weight of less than 2500 grams"},{"outcome_type":"secondary","measure":"Very low birth weight","time_frame":"At birth; vital records","description":"Infant born with a birth weight of less than 1500 grams"},{"outcome_type":"secondary","measure":"Birth weight (continuous)","time_frame":"At birth; vital records","description":"A continuous measure of infant birth weight (grams)"},{"outcome_type":"secondary","measure":"Preterm birth","time_frame":"At birth; vital records","description":"Infant born before 37 weeks' gestation (obstetric estimate)"},{"outcome_type":"secondary","measure":"Extremely preterm birth","time_frame":"At birth; vital records","description":"Infant born before 28 weeks' gestation"},{"outcome_type":"secondary","measure":"Gestational age at birth","time_frame":"At birth; vital records","description":"Gestational age at birth in weeks (continuous)"},{"outcome_type":"secondary","measure":"Neonatal morbidity","time_frame":"At birth; hospital discharge","description":"Assisted ventilation immediately after delivery, assisted ventilation for more than six hours, seizure, receipt of surfactant replacement therapy, and receipt of antibiotics for suspected sepsis."},{"outcome_type":"secondary","measure":"Cesarean delivery","time_frame":"At birth; vital records","description":"Cesarean delivery"},{"outcome_type":"secondary","measure":"Severe acute maternal morbidity","time_frame":"At birth; hospital discharge","description":"As defined by the CDC"},{"outcome_type":"secondary","measure":"Maternal mortality","time_frame":"One year postpartum; mortality records","description":"Death of mother within one year postpartum"},{"outcome_type":"secondary","measure":"Neonatal abstinence disorder (NAS) or maternal drug/substance abuse","time_frame":"Two years postpartum; Medicaid claims, hospital discharge","description":"Evidence of NAS or maternal drug or substance abuse in first two years postpartum"},{"outcome_type":"secondary","measure":"Number of emergency department visits during pregnancy","time_frame":"At birth; hospital discharge","description":"Number of emergency department visits during pregnancy"},{"outcome_type":"secondary","measure":"Dental visit during pregnancy","time_frame":"At birth; Medicaid claims and dental records","description":"Dental visit during pregnancy (preventive or treatment)"},{"outcome_type":"secondary","measure":"Ultrasound at 18-22 weeks","time_frame":"At birth; Medicaid claims","description":"Ultrasound at 18-22 weeks (anatomy scan)"},{"outcome_type":"secondary","measure":"Prenatal screenings","time_frame":"At birth; Medicaid claims","description":"Obstetric panel (D (Rh), RBC antibody screen, CBC, urine culture, urinalysis), STI screenings (HIV, Syphilis, Hep B, Chlamydia if <25, gonorrhea if <25), Group B screening, Glucose screening at 24-28 weeks"},{"outcome_type":"secondary","measure":"Mental health diagnosis or outpatient treatment","time_frame":"During pregnancy or 60 days postpartum; Medicaid claims","description":"Diagnosis for depression/anxiety/stress reaction or antidepressant prescription or outpatient mental health visit"},{"outcome_type":"secondary","measure":"Diagnosis of depression/anxiety/stress reaction","time_frame":"During pregnancy or 60 days postpartum; Medicaid claims","description":"Diagnosis of depression/anxiety/stress reaction"},{"outcome_type":"secondary","measure":"Antidepressant prescription","time_frame":"During pregnancy or 60 days postpartum; Medicaid claims","description":"Antidepressant prescription"},{"outcome_type":"secondary","measure":"Outpatient mental health visit","time_frame":"During pregnancy or 60 days postpartum; Medicaid claims","description":"Outpatient mental health visit"},{"outcome_type":"secondary","measure":"Mental health treatment follow up","time_frame":"120 days of treatment initiation; Medicaid claims","description":"Second antidepressant prescription or outpatient mental health visit within 120 days of treatment initiation (\"acute phase\")"},{"outcome_type":"secondary","measure":"Any mental health related emergency/inpatient visit","time_frame":"During pregnancy or 12 months postpartum; Hospital discharge","description":"Based on all-listed diagnoses (i.e. primary or secondary) for depression/anxiety/stress reaction"},{"outcome_type":"secondary","measure":"Number of mental health related emergency/inpatient visits","time_frame":"During pregnancy or 12 months postpartum; Hospital discharge","description":"Based on all-listed diagnoses (i.e. primary or secondary) for depression/anxiety/stress reaction"},{"outcome_type":"secondary","measure":"Health care encounter or mortality associated with ICD codes indicating major injury","time_frame":"24 months of life; Medicaid claims, hospital discharge, mortality records","description":"Child experiences a major injury"},{"outcome_type":"secondary","measure":"Health care encounter or mortality associated with ICD codes indicating concern for abuse or neglect","time_frame":"24 months of life; Medicaid claims, hospital discharge, mortality records","description":"Concern for abuse or neglect of child"},{"outcome_type":"secondary","measure":"Number of injuries","time_frame":"24 months of life; hospital discharge","description":"Number of injuries"},{"outcome_type":"secondary","measure":"Any emergency department visit for child","time_frame":"24 months of life; hospital discharge","description":"Child visit to the emergency department"},{"outcome_type":"secondary","measure":"Number of emergency department visits","time_frame":"24 months of life; hospital discharge","description":"Total number of child visits to the emergency department"},{"outcome_type":"secondary","measure":"Child mortality","time_frame":"24 months; Mortality records","description":"All-cause child mortality in first 24 months of life"},{"outcome_type":"secondary","measure":"Well-child visits","time_frame":"15 months; Medicaid claims","description":"Proportion of recommended well-child visits"},{"outcome_type":"secondary","measure":"Lead screening","time_frame":"15 months; Medicaid claims","description":"Child receives at least one lead screening"},{"outcome_type":"secondary","measure":"Developmental screening","time_frame":"12 months; Medicaid claims","description":"Child receives at least one developmental screening"},{"outcome_type":"secondary","measure":"Dental visit","time_frame":"24 months; Medicaid claims and dental records","description":"Child visits the dentist at least once in first 24 months"},{"outcome_type":"secondary","measure":"Flouride treatment","time_frame":"24 months; Medicaid claims and dental records","description":"Share of recommended fluoride treatments received by child"},{"outcome_type":"secondary","measure":"Inter-birth interval of < 24 months","time_frame":"24 months; vital records","description":"Having a subsequent birth within the first 24 months of the index birth"},{"outcome_type":"secondary","measure":"Inter-birth interval of < 15 months","time_frame":"15 months; vital records","description":"Having a subsequent birth within the first 21 months of the index birth"},{"outcome_type":"secondary","measure":"Inter-birth interval","time_frame":"60 months; vital records","description":"Continuous measure of inter-birth interval"},{"outcome_type":"secondary","measure":"Family planning visit (6 weeks)","time_frame":"6 weeks postpartum; Medicaid claims, hospital discharge","description":"Any family planning-related counseling or service"},{"outcome_type":"secondary","measure":"Received a highly or moderately effective method of contraception (6 weeks)","time_frame":"6 weeks postpartum; Medicaid claims, hospital discharge","description":"Received implant, IPP-LARC, LARC, or sterilization and moderately effective contraception to include path, ring, diaphragm, injectables and contraceptive pills"},{"outcome_type":"secondary","measure":"Received immediate postpartum long-acting reversible contraception (6 weeks)","time_frame":"6 weeks postpartum; Medicaid claims, hospital discharge","description":"Received Immediate postpartum long-acting reversible contraception in first 6 weeks postpartum"},{"outcome_type":"secondary","measure":"Family planning visit (1 year)","time_frame":"12 months postpartum; Medicaid claims, hospital discharge","description":"Any family planning-related counseling or service"},{"outcome_type":"secondary","measure":"Received a highly or moderately effective method of contraception (1 year)","time_frame":"12 months postpartum; Medicaid claims, hospital discharge","description":"Received implant, IPP-LARC, LARC, or sterilization and moderately effective contraception to include path, ring, diaphragm, injectables and contraceptive pills"},{"outcome_type":"secondary","measure":"Postpartum intrauterine device insertion (1 year)","time_frame":"12 months postpartum; Medicaid claims, hospital discharge","description":"Postpartum intrauterine device insertion in first 12 months postpartum"},{"outcome_type":"secondary","measure":"Time to first take-up of family planning counseling or service","time_frame":"24 months postpartum; Medicaid claims, hospital discharge","description":"Months from pregnancy to first take up of family planning counseling or service"},{"outcome_type":"secondary","measure":"Time to first take-up of highly effective contraceptive method","time_frame":"24 months postpartum; Medicaid claims, hospital discharge","description":"Months from discharge to first take up of highly effective contraceptive method (include implant, IPP-LARC, LARC, or sterilization)"},{"outcome_type":"secondary","measure":"Receipt of SNAP or WIC","time_frame":"During pregnancy, assessed up to 42 weeks; South Carolina Department of Social Services data and birth certificate data respectively","description":"Any receipt of Supplemental Nutrition Assistance Program or Special Supplemental Nutrition Program for Women, Infants, and Children during pregnancy"},{"outcome_type":"secondary","measure":"Number of months receiving SNAP or TANF","time_frame":"24 months postpartum; South Carolina Department of Social Services data","description":"Total months receiving Supplemental Nutrition Assistance Program or Temporary Assistance for Needy Families"},{"outcome_type":"secondary","measure":"Measure of SNAP or TANF benefit churn","time_frame":"24 months postpartum; South Carolina Department of Social Services data","description":"Receiving Supplemental Nutrition Assistance Program or Temporary Assistance for Needy Families at any time during a given year and having experienced at least one break in participation of four months or less that started and/or ended during the year"}]}
{"nct_id":"NCT02908087","start_date":"2016-03-31","phase":"Phase 2","enrollment":10,"brief_title":"Incretin-based Therapy in Early Diagnosed Type 1 Diabetes","official_title":"Incretin-based Therapy in Early Diagnosed Type 1 Diabetes","primary_completion_date":"2018-07-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2018-07-31","last_update":"2017-10-26","description":"The main objective of the trial is to study whether daily treatment with liraglutide improves insulin secretion and reduces the requirement of exogenous insulin, and whether liraglutide treatment is tolerable and safe in subjects aged 10-30 years, having an early diagnosis of type 1 diabetes (no symptoms, diagnosis in OGTT), and treated with insulin.","other_id":"LiraT1D10-30","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":10,"maximum_age":30,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  10-30 years of age\r\n\r\n          -  early diagnosis type 1 diabetes (no symptoms, diagnosis in OGTT)\r\n\r\n          -  not pregnant.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  allergic to liraglutide or other ingredients of Victoza\r\n\r\n          -  diabetic ketoacidosis\r\n\r\n          -  previous treatment in the last three months with any antidiabetic medication other\r\n             than insulin\r\n\r\n          -  impaired liver or kidney function or on dialysis\r\n\r\n          -  severe heart failure\r\n\r\n          -  severe stomach or gut problem resulting in gastroparesis, or inflammatory bowel\r\n             disease\r\n\r\n          -  past or current history of pancreatitis\r\n\r\n          -  serum calcitonin value above normal (>50 ng/l or 3.4pmol/l)\r\n\r\n          -  presence of any chronic metabolic, hematologic or malignant disease\r\n\r\n          -  obesity BMI 30\r\n\r\n          -  pregnant females and females of childbearing potential who are not using adequate\r\n             contraceptive methods.\r\n\r\n          -  breast-feeding\r\n      ","sponsor":"University of Oulu","sponsor_type":"Other","conditions":"Type 1 Diabetes","interventions":[{"intervention_type":"Drug","name":"Drug: Victoza (liraglutide)","description":"Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 6 months."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 6 months."}],"outcomes":[{"outcome_type":"primary","measure":"Serum C-peptide AUC","time_frame":"From baseline to 26 and 52 weeks","description":"Serum C-peptide area under the curve (AUC) during 2-hour MMTT (mixed-meal tolerance test)"},{"outcome_type":"secondary","measure":"Safety: Serum and urine amylase, serum lipase, serum calcitonin levels will be monitored","time_frame":"From baseline to 26 and 52 weeks","description":"Safety: Serum and urine amylase, serum lipase, serum calcitonin levels will be monitored during the 26 weeks treatment period and 26 weeks follow-up period"},{"outcome_type":"secondary","measure":"Number of hypoglycemia episodes","time_frame":"From baseline to 26 and 52 weeks","description":"Number of hypoglycemia episodes during the 26 weeks treatment period and 26 weeks follow-up period"},{"outcome_type":"secondary","measure":"Frequency of gastrointestinal side effects","time_frame":"12 months","description":"Frequency of gastrointestinal side effects (diarrhea, nausea, vomiting) during the 26 weeks treatment period and 26 weeks follow-up period"},{"outcome_type":"secondary","measure":"Insulin dose","time_frame":"From baseline to 26 and 52 weeks","description":"Insulin dose IU/kg/day"}]}
{"nct_id":"NCT02502331","start_date":"2016-03-31","phase":"Phase 3","enrollment":442,"brief_title":"Safety and Immunogenicity of a New Formulation of Euvichol","official_title":"A Randomized, Observer Blinded, Controlled Trial to Evaluate the Safety and Immunogenicity of a New Formulation of Euvichol (Killed Bivalent Whole Cell Oral Cholera Vaccine Manufactured by EuBiologics Co. Ltd.) in Healthy Individuals","primary_completion_date":"2016-06-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2016-08-31","last_update":"2015-12-17","description":"- Number of doses and intervals: Two doses, 2 weeks apart - Method of administration: Oral administration - Volume of vaccine to be administered: 1.5 mL/dose - Observational period: 4 weeks (2 weeks after each dose) - Number of visits: 3 visits 1. Visit 1: Screening and enrollment (1st dosing) 2. Visit 2: 2nd dosing 2 weeks after 1st dose (14+3 days) 3. Visit 3: 2 weeks after the 2nd dose (28+3 days), end of subject participation. This study will be carried out in healthy adults and children, at two sites, enrollment will be competitive between the sites. Subjects will be stratified according to age into adults (18~40 years of age) and children (1~17 years of age). According to the pre-generated randomization list, the participants will be randomized to the test or comparator groups (Visit 1) and will be given either the test vaccine or the comparator vaccine. For immunogenicity assessment, blood sample will be taken at Visit 1 (prior to vaccination), Visit 2 (prior to vaccination), and at the end-of-study Visit (Visit 3). For Safety assessment: the participants will be observed for 30 minutes post vaccination and instructed to record solicited adverse events that occur up to 6 days after vaccination on the participant diary card. This study is observer-blind: vaccine administrator and vaccine safety evaluator will be two distinct persons to avoid bias of safety assessment. Trial staff other than the vaccine administrator will remain blinded and will not handle the investigational product.","other_id":"IVI-CHOVI-EUVICHOL","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":1,"maximum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Subject willing to provide written informed consent to study participation voluntarily\r\n             provided by an individual or his/her legally acceptable representative.\r\n\r\n          2. Individuals aged 1 - 40 years.\r\n\r\n          3. An individual who can be followed up during the study period and is capable of\r\n             complying with the study requirements\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Known history of hypersensitivity reactions to other preventive vaccines.\r\n\r\n          2. Known history of immune function disorders including immunodeficiency diseases, or\r\n             chronic use of systemic steroids (> 20 mg/day prednisone equivalent for periods\r\n             exceeding 10 days), cytotoxic drugs or other immunosuppressants.\r\n\r\n          3. Severe chronic diseases, based on the judgment of the investigator.\r\n\r\n          4. 38 or higher body temperature measured prior to investigational product dosing.\r\n\r\n          5. Abdominal pain, nausea, vomiting, or decreased appetite within 24 hours prior to study\r\n             initiation.\r\n\r\n          6. Diarrhea or administration of antidiarrheal drugs or antibiotics to treat diarrhoea\r\n             within 1 week prior to study initiation.\r\n\r\n          7. Diarrhea or abdominal pain lasting 2 weeks or longer within 6 months prior to study\r\n             initiation.\r\n\r\n          8. Other vaccination within 1 week prior to study initiation or planned vaccination\r\n             during the study, except for tetanus toxoid vaccine.\r\n\r\n          9. Participation in another clinical trial with investigational product dosing within 1\r\n             month prior to study initiation.\r\n\r\n         10. Pregnant or lactating women, women of reproductive age planning pregnancy and/or\r\n             lactation before the end of the study period.\r\n\r\n         11. An individual thought to have difficulty participating in the study due to other\r\n             reasons, based on the judgment of the investigator\r\n\r\n         12. History of cholera vaccinations or history of cholera.\r\n\r\n         13. History of alcohol or substance abuse\r\n\r\n         14. Participant planning to move from the study area before the end of study period.\r\n      ","sponsor":"International Vaccine Institute","sponsor_type":"Other","conditions":"Cholera","interventions":[{"intervention_type":"Biological","name":"Biological: Test Oral Cholera Vaccine","description":"Thimerosal free, manufactured at 600 L scale killed bivalent (O1 and O139) whole cell-oral cholera vaccine (WC-OCV) manufactured by Eubiologics Co., Ltd."},{"intervention_type":"Biological","name":"Biological: Euvichol","description":"Licensed, manufactured at 100 L scale killed bivalent (O1 and O139) whole cell-oral cholera vaccine (WC-OCV) manufactured by Eubiologics Co., Ltd."}],"outcomes":[{"outcome_type":"primary","measure":"Immunogenicity endpoint for Inaba O1","time_frame":"28 days","description":"Geometric Mean Titer (GMT) of Vibriocidal antibodies against Inaba serogroup O1 post second dose"},{"outcome_type":"primary","measure":"Immunogenicity endpoint for Ogawa O1","time_frame":"28 days","description":"GMTof Vibriocidal antibodies against Ogawa serogroup O1 post second dose"},{"outcome_type":"primary","measure":"Immunogenicity endpoint O139","time_frame":"28 days","description":"GMT of Vibriocidal antibodies against serogroup O139 post second dose"},{"outcome_type":"secondary","measure":"Proportion of participants showing seroconversion against Inaba serogroup O1, Ogawa serogroup O1and serogroup O139 post vaccinations.","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Seroconversion is defined as 4-fold rise in vibriocidal antibody titer at Visit 3 two weeks after the second dose, compared to baseline titers, measured at Visit 1 prior to vaccination.","time_frame":"28 days"}]}
{"nct_id":"NCT02857504","start_date":"2016-03-31","phase":"N/A","enrollment":30,"brief_title":"One Lung Ventilation: Double Lumen Tube","official_title":"One Lung Ventilation: Double-lumen Tube With vs Without Carinal Hook","primary_completion_date":"2017-04-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2017-04-30","last_update":"2017-04-17","description":"One lung ventilation (OLV) has become a standard procedure for the vast majority of interventions in pulmonary surgery. It is used in both techniques: thoracotomy and videothoracoscopy (VATS). OLV can be provided by double lumen tube (DLT) with or without the hook. In our study the investigators want to find out if there is any advantage with one or another.","other_id":"137/02/15","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  planned thoracotomy or VATS surgical technique\r\n\r\n          -  with ASA (American Society of Anesthesiologist) physical status 1-3.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  ASA>3,\r\n\r\n          -  severe heart illness (NYHA >3),\r\n\r\n          -  severe pulmonary obstructive disease (FEV1<40%),\r\n\r\n          -  neurologic disorders and\r\n\r\n          -  patients with other respiratory or lung disease.\r\n      ","sponsor":"University Medical Centre Ljubljana","sponsor_type":"Other","conditions":"Double Lumen Tube","interventions":[{"intervention_type":"Device","name":"Device: double lumen tube with a hook","description":"The tube with the hook (after passing the bronchial cuff trough the vocal cords) was rotated for 180 degrees to the left and removed the stylet and when the hook passed the vocal cords, the tube was rotated for 90 degrees back to the right and push it into the bronchus. Following formula was used for the right depth (height (cm)/10 + 12 (cm)) of the tube without the hook. The tube with hook was inserted into the bronchus so that hook was placed on the carina and stopped."},{"intervention_type":"Device","name":"Device: double lumen tube without a hook","description":"Tube without the hook was inserted with the following technique: after the bronchial cuff was passed the vocal cords, the stylet was removed and the tube was rotated 90 st towards left."}],"outcomes":[{"outcome_type":"primary","measure":"intubation","time_frame":"intraoperative","description":"The time needed for tube insertion (time from seeing the vocal cords to final position of the tube) was measured."}]}
{"nct_id":"NCT02708888","start_date":"2016-03-31","phase":"N/A","enrollment":39,"brief_title":"Stroke Walking Explained After Trunk Training","official_title":"Effectiveness of Additional Trunk Exercises on Gait Performance: a Randomised Controlled Trial","primary_completion_date":"2017-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-08-31","last_update":"2019-02-19","description":"The aim of SWEAT study is to further explore the effects of additional customized trunk exercises on clinical and biomechanical gait performance. Despite of the evidence demonstrating the importance of trunk control after stroke, studies about the effects of trunk rehabilitation on gait performance are inconsistent. The findings of this study might lead to new scientific insights in the importance of the trunk during gait rehabilitation in people suffering from stroke submitted to a rehabilitation hospital.","other_id":"TVC-1","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Haemorrhagic or ischaemic stroke diagnosis has to be confirmed by the consultant\r\n             appointed at the rehabilitation centre on the basis of CT or MRI imaging\r\n\r\n          -  Patients with a history of first stroke\r\n\r\n          -  Stroke onset within five months\r\n\r\n          -  Patients who are able to sit independently for 30 seconds on a stable surface\r\n\r\n          -  Hospitalized in the rehabilitation hospital RevArte\r\n\r\n          -  Written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  A score of 20 or higher on the Trunk Impairment Scale\r\n\r\n          -  A score of 2 or lower on the Functional Ambulation Categories\r\n\r\n          -  Patients suffering from other neurological and orthopaedic disorders that could\r\n             influence motor performance and balance\r\n\r\n          -  Patients not able to understand instructions\r\n      ","sponsor":"Universiteit Antwerpen","sponsor_type":"Other","conditions":"Stroke","interventions":[{"intervention_type":"Other","name":"Other: Trunk training","description":"The experimental group receives 16 hours of additional trunk training (4 days/week, 4 weeks) focusing on trunk muscle strength, coordination and selective movements executed on stable and unstable surfaces."},{"intervention_type":"Other","name":"Other: Cognitive exercises","description":"The control group will be receiving the same amount of repetitive cognitive exercises within arm's range to ensure no anticipatory postural adjustments of the trunk."}],"outcomes":[{"outcome_type":"primary","measure":"The change in Tinetti Performance Oriented Mobility Assessment","time_frame":"week 0, week 5, and week 9","description":"Tinetti Test measures gait and balance on a 3-point ordinal scale ranging from 0 to 2. The maximum score of the total Tinetti is 28 points, whereby a maximum of 12 and 16 points can be obtained for gait and balance subscales."},{"outcome_type":"secondary","measure":"The change in temporal gait parameters","time_frame":"week 0, week 5, and week 9","description":"The following temporal gait parameters will be investigated: stride length (m), step length (m), and step width (m). These parameters examine the difference in distance."},{"outcome_type":"secondary","measure":"The change in kinematic parameters of the trunk, hip, knee, and ankle","time_frame":"week 0, week 5, and week 9","description":"The following kinematic parameters will be assessed: mean angle during stance (°), mean angle during swing (°), minimum angle during stance (°), maximal angle during stance (°), minimal angle during swing (°), maximal angle during swing (°), angle at foot strike (°), angle at foot off (°), range of motion (°). These parameters examine the difference in joint angles."},{"outcome_type":"secondary","measure":"The change is muscle activity of the trunk and lower legs during walking","time_frame":"week 0, week 5, and week 9","description":"Muscle activity of the trunk and lower limbs will be registered by means of surface EMG. The amplitude and timing of muscle contractions will be assessed."},{"outcome_type":"other","measure":"The change in Trunk Impairment Scale (TIS)","time_frame":"week 0, week 5, and week 9","description":"The TIS consists of 3 subscales of static, dynamic sitting balance and trunk coordination. TIS scores range from a minimum of 0 to a maximum of 23, subscales score up to 7, 10 and 6 points, respectively. A higher score indicates better truncal function. The static sitting balance subscale evaluates whether a person can sit independently and remain seated with legs crossed. The dynamic sitting balance subscale assesses the ability to actively shorten each side of the trunk, initiated from either the shoulder or pelvic girdle. The trunk coordination subscale tests the ability to rotate the shoulder girdle and the pelvic girdle."},{"outcome_type":"other","measure":"The change in the Barthel Index (BI)","time_frame":"week 0, week 5, and week 9","description":"The BI is an index assessing the independency of a patient's performance concerning the activities of daily living. The maximum score of the BI gives a score on 100 with increments of five points to assess is if the patient is fully dependent, independent, or needs some help regarding ten topics: feeding, bathing, grooming, dressing, toilet use, bowel and bladder continence, transferring, mobility, and stair climbing"}]}
{"nct_id":"NCT02742077","start_date":"2016-03-31","phase":"N/A","enrollment":20,"brief_title":"Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease II","official_title":"CorPath 200 RAPID II Study (Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease)","primary_completion_date":"2016-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-08-31","last_update":"2020-11-04","description":"The purpose of this study is to evaluate the safety and performance of the CorPath 200 System in the remote delivery and manipulation of guidewires and rapid exchange catheters for use in percutaneous vascular interventions.","other_id":"2016-01","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        General Inclusion Criteria\r\n\r\n          -  At least 18 years of age;\r\n\r\n          -  Symptomatic disease: presence of critical limb ischemia (including tissue loss or rest\r\n             pain), or lifestyle-limiting claudication requiring intervention in the\r\n             femoropopliteal arteries; and\r\n\r\n          -  The subject has been informed of the nature of the study and agrees to its provisions\r\n             and has provided written informed consent.\r\n\r\n        Angiographic Inclusion Criteria Femoropopliteal artery lesion(s) with stenosis (>50%) or\r\n        occlusion of up to 120 mm in length as determined by imaging (MRA or Angio) prior to index\r\n        interventional procedure.\r\n\r\n        Exclusion Criteria:\r\n\r\n        General Exclusion Criteria\r\n\r\n        If any of the following criteria are met, the subject cannot be enrolled in this study:\r\n\r\n          -  Failure/inability/unwillingness to provide informed consent;\r\n\r\n          -  Target vessel has been previously treated with bypass; or\r\n\r\n          -  Enrolled in concurrent clinical study.\r\n\r\n        Angiographic Exclusion Criteria\r\n\r\n         Target vessel:\r\n\r\n          -  Shows evidence of previous dissection or perforation, or\r\n\r\n          -  Has adjacent acute thrombus; or\r\n\r\n          -  Has a pre-existing target artery aneurysm or perforation or dissection of the target\r\n             artery prior to initiation of the interventional procedure.\r\n      ","sponsor":"Corindus Inc.","sponsor_type":"Industry","conditions":"Peripheral Arterial Disease","interventions":[{"intervention_type":"Device","name":"Device: Robotic-assisted peripheral vascular intervention","description":"Remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventions."}],"outcomes":[{"outcome_type":"primary","measure":"Clinical Success","time_frame":"72 hours or hospital discharge, whichever comes first.","description":"Defined as <50% residual stenosis in all CorPath 200 System treated lesions at the completion of the interventional procedure in the absence of device-related serious adverse events (SAE)."},{"outcome_type":"primary","measure":"Adverse Events","time_frame":"Procedure","description":"No device-related serious adverse events."},{"outcome_type":"secondary","measure":"Operator Radiation Exposure Dose","time_frame":"Procedure","description":"Physician operator radiation exposure as recorded on personal Enterprise Dose Dashboard (EDD; Landauer) dosimeters"},{"outcome_type":"secondary","measure":"Patient Radiation Exposure Dose","time_frame":"Procedure","description":"Patient Radiation Dose-area-product (DAP)"}]}
{"nct_id":"NCT03261232","start_date":"2016-03-31","enrollment":65,"brief_title":"Search for Prognostic Factors Associated With Better Survival in Refractory Cardiac Arrest","official_title":"Prognostic Factors in Refractory Cardiac Arrest Treated With Extracorporeal Life Support at Dijon CHU","primary_completion_date":"2018-03-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2018-03-31","last_update":"2017-08-24","description":"Through this retrospective observational study (over 4 years; period analysed: 1st January 2011 to 31st December 2014), we looked for prognostic factors associated with better survival in refractory cardiac arrest by: - assessing the overall survival rate - evaluating the frequency of intra et extra-hospital events and by comparing these with the survival rate - studying no flow, low flow, rhythm at initial management, troponinemia, lactatemia and blood pH in the different groups.","other_id":"ELLOUZE 2016 Pro-ACR","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":75,"population":"Patients with in-hospital or out-of-hospital refractory CA who underwent ECLS","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with in-hospital or out-of-hospital refractory CA who underwent ECLS\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  CA occurring during cardiac surgery\r\n\r\n          -  Age > 75 years or < 18 years\r\n      ","sponsor":"Centre Hospitalier Universitaire Dijon","sponsor_type":"Other","conditions":"Cardiac Arrest (CA)|ExtraCorporeal Life Support (ECLS)","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Survival rate","time_frame":"at baseline"},{"outcome_type":"primary","measure":"Death rate","time_frame":"at baseline"}]}
{"nct_id":"NCT02617966","start_date":"2016-03-24","phase":"N/A","enrollment":370,"brief_title":"Rod and Cone Mediated Function in Retinal Disease","official_title":"Rod and Cone Mediated Function in Retinal Disease","primary_completion_date":"2024-12-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2024-12-30","last_update":"2021-09-14","description":"Background: Retinal diseases cause the loss of rod and cone photoreceptors. Symptoms include vision loss and night blindness. Researchers want to learn about rod and cone function in healthy people and people with retinal disease. They want to know if how well a person sees in the dark can test the severity of retinal disease. Objectives: To find out if how well a person sees in the dark can test the severity of retinal disease. To find out if this can help detect retinal disease and track its changes. Eligibility: People ages 5 and older with: Retinal disease OR 20/20 vision or better with or without correction in at least one eye Design: Participants will be screened with medical and eye history and eye exam. Those with retinal disease will also have: Eye imaging: Drops dilate the eye and pictures are taken of it. Visual field testing: Participants look into a bowl and press a button when they see light. Electroretinogram (ERG): An electrode is taped to the forehead. Participants sit in the dark with their eyes patched for 30 minutes. Then they get numbing drops and contact lenses. Participants watch lights while retina signals are recorded. Visit 1 will be 3-8 hours. Participants will have up to 6 more visits over 6-12 months. Visits include: Eye exam and imaging Time course of dark adaptation: Participants view a background light for 5 minutes then push a button when they see colored light. Dark adapted sensitivity: Participants sit in the dark for 45 minutes. They push a button when they see colored light. For participants with retinal disease, ERG and visual field testing","other_id":"160024","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":5,"population":"","criteria":"\n        -  INCLUSION CRITERIA:\r\n\r\n          -  Participant must be 5 years of age or older.\r\n\r\n          -  Participant (or legal guardian) must understand and sign the protocol s informed\r\n             consent document.\r\n\r\n          -  Participant must be able to cooperate with the testing required for this study.\r\n\r\n        For Participants with retinal disease only:\r\n\r\n          -  Participant must have retinal disease, defined as evidence of loss of retinal\r\n             dysfunction and/or degeneration as established by standard clinical methods including\r\n             perimetry, ERG and imaging.\r\n\r\n          -  Participant must have a measurable visual acuity.\r\n\r\n        For Healthy Volunteers only:\r\n\r\n        -Participant must have visual acuity of 20/20 or better, with or without correction (e.g.,\r\n        glasses or contact lens) in at least one eye.\r\n\r\n        EXCLUSION CRITERIA:\r\n\r\n        -Participant with changes in pre-retinal media sufficient to obscure a view of the retina.\r\n      ","sponsor":"National Eye Institute (NEI)","sponsor_type":"NIH","conditions":"Retinal Degeneration|Retinitis Pigmentosa|Stargardt's Disease","interventions":[{"intervention_type":"Device","name":"Device: Medmont Darl Adapted Chromatic (DAC)","description":"uses blue and red light to measure adapted retinal sensitivity to light and is not currently FDA approved for clinical use."},{"intervention_type":"Device","name":"Device: RetMap, RM Electrode","description":"used for recording ERGs"},{"intervention_type":"Device","name":"Device: MonCvONE electrophysiology","description":"electrophysiology unit"}],"outcomes":[{"outcome_type":"primary","measure":"The primary outcomes for this study are to establish normal ranges for the kinetics of dark adaptation and dark adapted retinal sensitivity for the Medmont DAC blue and red stimuli and for RF hyperacuity on the Display++.","time_frame":"ongoing, up to 10 visits in 5 years","description":"The primary outcomes for this study are to establish normal ranges for the kinetics of dark adaptation and dark adapted retinal sensitivity for the Medmont DAC blue and red stimuli and for RF hyperacuity on the Display++."},{"outcome_type":"secondary","measure":"The secondary outcomes will be to examine changes in the kinetics of dark adaptation and dark-adapted retinal sensitivity, and scotopic and photopic RF hyperacuity in participants with retinal disease.","time_frame":"ongoing, up to 10 visits in 5 years","description":"The secondary outcomes will be to examine changes in the kinetics of dark adaptation and dark-adapted retinal sensitivity, and scotopic and photopic RF hyperacuity in participants with retinal disease."}]}
{"nct_id":"NCT02600897","start_date":"2016-03-23","phase":"Phase 1","enrollment":114,"brief_title":"A Study of Obinutuzumab, Polatuzumab Vedotin, and Lenalidomide in Relapsed or Refractory Follicular Lymphoma (FL) and Rituximab in Combination With Polatuzumab Vedotin and Lenalidomide in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","official_title":"A Phase Ib/II Study Evaluating the Safety and Efficacy of Obinutuzumab in Combination With Polatuzumab Vedotin and Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma and Rituximab in Combination With Polatuzumab Vedotin and Lenalidomide in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma","primary_completion_date":"2022-02-23","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2022-02-23","last_update":"2021-08-09","description":"This study will evaluate the safety, efficacy, and pharmacokinetics of induction treatment with obinutuzumab, polatuzumab vedotin, and lenalidomide in participants with relapsed or refractory (R/R) follicular lymphoma (FL) and rituximab in combination with polatuzumab vedotin and lenalidomide in participants with R/R diffuse large B-cell lymphoma (DLBCL), followed by post-induction treatment with obinutuzumab in combination with lenalidomide in participants with FL who achieve a complete response (CR), partial response (PR), or stable disease (SD) at end of induction (EOI) and post-induction treatment with rituximab plus lenalidomide in participants with DLBCL who achieve a CR or PR at EOI.","other_id":"GO29834","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age greater than or equal to (>/=) 18 years\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\r\n\r\n          -  For obinutuzumab in combination with polatuzumab vedotin and lenalidomide (G + Pola +\r\n             Len) treatment group: R/R FL after treatment with at least one prior\r\n             chemoimmunotherapy regimen that included an anti-CD20 monoclonal antibody and for\r\n             which no other more appropriate treatment option exists as determined by the\r\n             investigator\r\n\r\n          -  For rituximab in combination with polatuzumab vedotin and lenalidomide (R + Pola +\r\n             Len) treatment group: R/R DLBCL after treatment with at least one prior\r\n             chemoimmunotherapy regimen that included an anti-CD20 monoclonal antibody in patients\r\n             who are not eligible for autologous stem-cell transplantation or who have experienced\r\n             disease progression following treatment with high-dose chemotherapy plus autologous\r\n             stem-cell transplantation\r\n\r\n          -  Histologically documented CD20-positive B-cell lymphoma as determined by the local\r\n             laboratory\r\n\r\n          -  fluorodeoxyglucose (FDG)-avid lymphoma (i.e., positron emission tomography\r\n             (PET)-positive lymphoma)\r\n\r\n          -  At least one bi-dimensionally measurable lesion\r\n\r\n          -  Agreement to remain abstinent or use adequate contraception, among women or men of\r\n             childbearing potential\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Grade 3b follicular lymphoma\r\n\r\n          -  History of transformation of indolent disease to diffuse large B-cell lymphoma (DLBCL)\r\n\r\n          -  Known CD20-negative status at relapse or progression\r\n\r\n          -  Central nervous system (CNS) lymphoma or leptomeningeal infiltration\r\n\r\n          -  Prior allogeneic stem-cell transplantation (SCT), or autologous SCT within 100 days\r\n             prior to Day 1 of Cycle 1\r\n\r\n          -  Current use of systemic immunosuppressant(s), or prior anti-cancer therapy to include:\r\n             lenalidomide, fludarabine, or alemtuzumab within 12 months; radioimmunoconjugate\r\n             within 12 weeks; mAb or antibody-drug conjugate within 4 weeks; or\r\n             radiotherapy/chemotherapy/hormone therapy/targeted small-molecule therapy within 2\r\n             weeks prior to Day 1 of Cycle 1\r\n\r\n          -  Active infection\r\n\r\n          -  Positive for human immunodeficiency virus (HIV) or hepatitis B or C\r\n\r\n          -  Receipt of a live virus vaccine within 28 days prior to Day 1 of Cycle 1\r\n\r\n          -  Poor hematologic, renal, or hepatic function\r\n\r\n          -  Pregnant or lactating women\r\n\r\n          -  Life expectancy less than (<) 3 months\r\n      ","sponsor":"Hoffmann-La Roche","sponsor_type":"Industry","conditions":"Relapsed or Refractory Follicular Lymphoma, Relapsed or Refractory Diffuse Large B-Cell Lymphoma","interventions":[{"intervention_type":"Drug","name":"Drug: Lenalidomide","description":"All participants will receive lenalidomide oral capsules at doses of 10, 15, or 20 milligrams (mg) on Days 1 to 21 of each 28-day cycle for up to 6 Cycles in dose escalation phase followed by post-induction treatment at a dose of 10 mg once daily on Days 1 to 21 of each subsequent 28-day cycle. Post-induction lenalidomide may continue for up to 12 months until disease progression or unacceptable toxicity for participants with R/R FL and up to 6 months until disease progression or unacceptable toxicity for participants with R/R DLBCL."},{"intervention_type":"Drug","name":"Drug: Obinutuzumab","description":"Participants will receive a fixed dose of obinutuzumab, 1000 mg via intravenous (IV) infusion to be given on Days 1, 8 and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 followed by post-induction treatment at a dose of 1000 mg via IV infusion on Day 1 of every other month for up to 24 months until disease progression or unacceptable toxicity."},{"intervention_type":"Drug","name":"Drug: Polatuzumab Vedotin","description":"Participants with R/R FL will receive polatuzumab vedotin via IV infusion at doses of 1.4 or 1.8 milligrams per kilogram (mg/kg) on Day 1 of each 28-day cycle for up to 6 months during induction treatment. Participants wit R/R DLBCL will receive polatuzumab vedotin via IV infusion at dose 1.8 mg/kg on Day 1 of each 28-day cycle for up to 6 months during induction treatment."},{"intervention_type":"Drug","name":"Drug: Rituximab","description":"Participants will receive a fixed dose of rituximab, 375 mg/m^2 via intravenous (IV) infusion to be given on Days 1 of Cycle 1 to 6 followed by post-induction treatment at a dose of 375 mg/m^2 via IV infusion on Day 1 of every other month for up to 6 months, until disease progression or unacceptable toxicity."}],"outcomes":[{"outcome_type":"secondary","measure":"Percentage of Participants With Best Response of Clinical Response (CR) or Partial Response (PR), Determined by the Investigator on the Basis of CT Scans Alone","time_frame":"Up to approximately 3 years"},{"outcome_type":"primary","measure":"Percentage of Participants with CR, Determined by an Independent Review Committee (IRC) on the Basis of Positron Emission Tomography (PET) and Computed Tomography (CT) Scans","time_frame":"Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks)"},{"outcome_type":"primary","measure":"Percentage of Participants with Adverse Events (AEs)","time_frame":"Up to approximately 3 years"},{"outcome_type":"primary","measure":"Percentage of Participants with Dose-Limiting Toxicities (DLTs)","time_frame":"Up to approximately 3 years"},{"outcome_type":"secondary","measure":"Percentage of participants with CR, determined by the investigator on the basis of PET and CT scans","time_frame":"Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks)"},{"outcome_type":"secondary","measure":"Percentage of Participants with CR, Determined by the Independent Review Committee (IRC) and Investigator on the Basis of CT Scans Alone","time_frame":"Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks)"},{"outcome_type":"secondary","measure":"Percentage of Participants with Objective Response, Determined by the IRC and Investigator on the Basis of PET and CT Scans","time_frame":"Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks)"},{"outcome_type":"secondary","measure":"Percentage of Participants with Objective Response, Determined by the IRC and Investigator on the Basis of CT Scans Alone","time_frame":"Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks)"},{"outcome_type":"secondary","measure":"Percentage of Participants With Objective Response, Determined by the Investigator on the Basis of CT Scans Alone","time_frame":"Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks)"},{"outcome_type":"secondary","measure":"Observed Serum Obinutuzumab Concentration","time_frame":"Pre-dose and/or 30 minutes post-dose on Day 1 of Cycles 1, 2, 4, and 6 during induction; pre-dose on Day 1 of Months 1, 7, 13, and/or 19 during the post-induction phase; then up to 2 years after last dose as available (maximum 5 years)"},{"outcome_type":"secondary","measure":"Observed Serum Rituximab Concentration","time_frame":"Pre-dose and/or 30 minutes post-dose on Day 1 of Cycles 1, 2, 4, and 6 during induction; pre-dose on Day 1 of Months 1, 7, 13, and/or 19 during the post-induction phase; then up to 2 years after last dose as available (maximum 5 years)"},{"outcome_type":"secondary","measure":"Observed Serum and Plasma Polatuzumab Vedotin Concentration","time_frame":"Pre-dose and/or 30 minutes post-dose on Days 1, 8, and 15 of Cycle 1; pre-dose and/or 30 minutes post-dose on Day 1 of Cycles 2, 4, and 6 during induction; then up to 2 years after last dose as available (maximum 5 years)"},{"outcome_type":"secondary","measure":"Observed Plasma Lenalidomide Concentration","time_frame":"Pre-dose and/or 0.5, 1, 2, 4, and 8 hours post-dose on Days 1 and 15 of Cycle 1 and on Day 1 of Cycle 6 (maximum 5 years)"},{"outcome_type":"secondary","measure":"Percentage of Participants with Human Anti-human Antibodies (HAHAs) to Obinutuzumab","time_frame":"Pre-dose on Day 1 of Cycles 1 and 6 during induction; then up to 2 years after last dose as available (maximum 5 years)"},{"outcome_type":"secondary","measure":"Percentage of Participants with Human Anti-chimeric Antibodies (HACAs) to Rituximab","time_frame":"Pre-dose on Day 1 of Cycles 1 and 6 during induction; then up to 2 years after last dose as available (maximum 5 years)"},{"outcome_type":"secondary","measure":"Percentage of Participants with Anti-therapeutic Antibodies (ATAs) to Polatuzumab Vedotin","time_frame":"Pre-dose on Day 1 of Cycles 1, 2, and 4 during induction; then up to 2 years after last dose as available (maximum 5 years)"}]}
{"nct_id":"NCT02688374","start_date":"2016-03-11","phase":"Phase 1","enrollment":45,"brief_title":"A Bioequivalence Study of Three, 2 mg Nicotine Chewing Gums (Two Tests and One Reference) in Healthy Adult Smokers","official_title":"A Single-Dose, Open-Label, Three-way Crossover Bioequivalence Study of Three, 2 mg Nicotine Chewing Gums (Two Tests and One Reference) in Chinese Male Healthy Adult Smokers","primary_completion_date":"2016-06-12","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-06-12","last_update":"2017-12-19","description":"This is a randomized, open-label, single-dose, three-period, crossover, single-center comparative bioavailability (BA) study under fasting condition in Chinese healthy male adult participants with a history of cigarette smoking. The participants will be admitted to the investigational clinic at least 38 hours before dosing and will remain domiciled until the completion of all study procedures at approximately 24 hours after dosing. Three toothpastes (one is commercial non-medicated non-nicotine containing chewing gum and other two are nicotine containing gums) will be provided across the 3 treatment periods. During each of the 3 treatment periods, participants will be under supervision in a non-smoking area and will abstain from smoking.There will be a total of at least 7 days and not more than 10 days (clinical furlough period) between treatment periods. Twenty (20) blood samples will be collected for pharmacokinetic (PK) analysis at baseline and multiple time points following study drug administration. The trial duration will be approximately 49 days and up to 55 days from screening to study end including the screening period.","other_id":"204979","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Participants must understand and provide written informed consent before any\r\n             assessment is performed, understand the study procedures, and be willing to complete\r\n             the required assessments and the study.\r\n\r\n          -  Chinese male participants between 18 and 45 years of age (inclusive) in general good\r\n             physical health as judged by the Investigator.\r\n\r\n          -  Normal vital signs as follows:\r\n\r\n          -  Oral body temperature between 35.0 and 37.5 C (95 and 99.5 F) inclusive\r\n\r\n          -  Supine systolic blood pressure between 90 and 140 mmHg inclusive\r\n\r\n          -  Supine diastolic blood pressure between 55 and 90 mmHg inclusive\r\n\r\n          -  Pulse rate between 50 and 100 beats per minute (bpm) inclusive\r\n\r\n          -  History of cigarette smoking of at least 10 cigarettes per day continuously for the\r\n             past 3 months prior to screening.\r\n\r\n          -  Body weight  50 kg, Body Mass Index (BMI) between 19 and 28 at screening.\r\n\r\n          -  Ability to communicate and comply with all study requirements including the study\r\n             specific chewing and swallowing procedures.\r\n\r\n        Exclusion Criteria:-\r\n\r\n          -  Use of other investigational drugs within 30 days or 10 half-lives of enrollment,\r\n             whichever is longer.\r\n\r\n          -  History of or known hypersensitivity to the study drug or excipients.\r\n\r\n          -  Diagnosis of long QT syndrome or QTc > 450 msec for males at screening.\r\n\r\n          -  Any surgical or medical condition which may significantly alter the absorption,\r\n             distribution, metabolism or excretion of any drug substance.\r\n\r\n          -  History of malignancy or neoplastic disease of any organ system treated or untreated,\r\n             orthostatic hypotension, cardiovascular disease, stroke, TIA, fainting or blackouts,\r\n             clinically significant metabolic, pulmonary, neurological, hematological, autoimmune,\r\n             psychiatric or endocrine disorders.. within the past 5 years prior to screening.\r\n\r\n          -  Any evidence of cardiovascular, pulmonary, renal, hepatic, gastrointestinal,\r\n             hematological, endocrinological, metabolic, autoimmune, neurological, psychiatric,\r\n             other diseases or other clinically significant laboratory findings at screening.\r\n\r\n          -  Participant has used any medication within two weeks before first scheduled study drug\r\n             administration or within less than 10 times the elimination half-life of the\r\n             respective drug.\r\n\r\n          -  Unable to comply with the chewing and/or swallowing rhythm requirements (> 5%\r\n             deviation of the total counts over 30 minutes) after trying either one of the two\r\n             training sessions for 3 times.\r\n\r\n          -  CO > 12 ppm after at least 38 hours confinement period in clinics prior to first\r\n             dosing.\r\n\r\n          -  Participants reports consumption of any drug metabolizing enzyme inducing or\r\n             inhibiting aliments, evidence of current alcohol abuse or reports consumption\r\n             exceeding 35 g of pure alcohol per day.\r\n\r\n          -  Any history of drug hypersensitivity, asthma, urticaria, or other significant allergic\r\n             diathesis, positive results in any of the virology tests for Human immunodeficiency\r\n             virus (HIV)-Ab, Hepatitis C virus (HCV)-Ab, Surface antigen of the hepatitis B virus\r\n             (HBs-Ag), and Tp-Ab.\r\n\r\n          -  Participation in a previous clinical study with or without another investigational\r\n             product and with ~470 ml blood drawn, or blood donation within the last 3 months prior\r\n             to screening or previous enrollment into the current study.\r\n\r\n          -  Vulnerable individual\r\n\r\n          -  Inability to be venipuncture and/or tolerate venous access, unwilling to accept slight\r\n             irritation of the throat and increased salivation due to nicotine gum administration.\r\n\r\n          -  Unable or unwilling to discontinue the use or consumption of cigarette smoking, any\r\n             nicotine containing products, Oral, local or topical pharmaceutical agents,\r\n             consumption of caffeine/theophylline - containing products, grapefruit, Seville\r\n             orange, orange, lemon, lime, apple, and pineapple, performance of unaccustomed\r\n             strenuous physical exercise.\r\n      ","sponsor":"GlaxoSmithKline","sponsor_type":"Industry","conditions":"Tobacco Use Disorder","interventions":[{"intervention_type":"Other","name":"Other: Treatment A: Nicorette 2 mg coated mint gum","description":"Participants will be administered with 2 mg coated mint gum of Nicorette"},{"intervention_type":"Other","name":"Other: Treatment B: Nicotinell 2 mg coated mint gum","description":"Participants will be administered with 2 mg coated mint gum of Nicotinell"},{"intervention_type":"Other","name":"Other: Treatment C: Nicotinell 2 mg coated fruit flavor gum","description":"Participants will be administered with 2 mg coated fruit flavor gum of Nicotinell"}],"outcomes":[{"outcome_type":"primary","measure":"Area under the curve from time zero to last sampling time [AUC(0-t)]","time_frame":"2 days","description":"AUC(0-t) will be calculated using the trapezoidal rule. Twenty (20) blood samples will be collected at baseline and multiple timepoints following study drug administration."},{"outcome_type":"primary","measure":"Area under the curve from time zero extrapolated to infinity [AUC(0-inf)]","time_frame":"2 days","description":"The area under the plasma concentration versus time curve will be calculated from time 0 to infinity where AUC = AUClast + Clast/λz Clast is the concentration at the last measurable sampling time point and λz is the terminal elimination rate constant. Twenty (20) blood samples will be collected at baseline and multiple timepoints following study drug administration."},{"outcome_type":"primary","measure":"Maximum plasma concentration (Cmax)","time_frame":"2 days","description":"Cmax will be obtained graphically from the plasma concentration over time profile. Twenty (20) blood samples will be collected at baseline and multiple timepoints following study drug administration."},{"outcome_type":"primary","measure":"Time to reach maximum plasma concentration (Tmax)","time_frame":"2 days","description":"Tmax will be obtained graphically from the plasma concentration over time profile. Twenty (20) blood samples will be collected at baseline and multiple timepoints following study drug administration."},{"outcome_type":"primary","measure":"Termination rate constant (Lambda_z)","time_frame":"2 days","description":"Lambda_z will be computed as the slope of the regression line of ln (C(t)) on time. Twenty (20) blood samples will be collected at baseline and multiple timepoints following study drug administration."},{"outcome_type":"primary","measure":"Elimination half life (t1/2)","time_frame":"2 days","description":"T1/2 will be computed as T1/2 = 0.693/ λz. Twenty (20) blood samples will be collected at baseline and multiple timepoints following study drug administration."},{"outcome_type":"primary","measure":"Systemic clearance (CL/F)","time_frame":"2 days","description":"CL/F will be calculated as the Dose/AUCinf, where Dose is the actual nicotine dose released. Twenty (20) blood samples will be collected at baseline and multiple timepoints following study drug administration."},{"outcome_type":"primary","measure":"Apparent volume of distribution (Vd/F)","time_frame":"2 days","description":"Vd/F will be determined by the following equation: Vz/F = Dose/(lambda_z · AUCinf), where Dose is the actual nicotine dose released. Twenty (20) blood samples will be collected at baseline and multiple timepoints following study drug administration."}]}
{"nct_id":"NCT02604186","start_date":"2016-03-09","phase":"Phase 2/Phase 3","enrollment":55,"brief_title":"Effects of Botulinum Toxin Injections in Patients With Hereditary Spastic Paraplegia","official_title":"Botulinum Toxin in Patients With Hereditary Spastic Paraplegia: a Randomized, Double-blind, Placebo-controlled, Crossover Study","primary_completion_date":"2017-03-15","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-03-15","last_update":"2017-11-07","description":"Hereditary spastic paraplegias constitute a heterogeneous group of diseases with the common predominant feature of spasticity of the lower limbs. The clinical picture is composed of difficulty walking, exaggerated deep reflexes, pathological reflexes such as the Babinski sign, sphincter disturbances and various degrees of weakness as well as sensory disturbances. Spasticity is the symptom that provoques greater incapacity. Although there have been recent advances in the genetic and pathogenic characterization of SPG there is scarcity of therapeutic options. The Botulinum Toxin (BTx) is a well established treatment for movement disorders such as cervical dystonia, blepharospasm, and arm spastic following stroke. Therefore, the investigators propose the execution of a randomized, double-blind, placebo-controlled, crossover study to evaluate the efficacy of the treatment with Btx over SPG patient's gait. The primary outcome measure will be gait velocity with the 10 meter walking test 8 weeks after injection. Each participant will be submitted to one injection session of Btx and one of placebo (consisting of sterile sodium chloride), each one separated by a period of 6 months. The primary and secondary outcomes will be evaluated by a blind investigator 8 weeks after each injection session.","other_id":"CAAE: 48177315.9.1001.5404","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age between 18 and 80 years\r\n\r\n          -  Clinical diagnosis of Hereditary Spastic Paraplegia\r\n\r\n          -  Ability to walk at least 10 meters: Assistive devices are permitted\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Wheelchair bound patients\r\n\r\n          -  Additional neurological symptoms that may significantly impact gait such as ataxia,\r\n             polyneuropathy or dementia.\r\n\r\n          -  Fixed tendon contractures\r\n\r\n          -  Antecedents of allergy or adverse reaction to botulinum toxin\r\n\r\n          -  Pregnancy or breastfeeding condition\r\n\r\n          -  Mental retardation\r\n\r\n          -  Dementia\r\n      ","sponsor":"University of Campinas, Brazil","sponsor_type":"Other","conditions":"Hereditary Spastic Paraplegia","interventions":[{"intervention_type":"Other","name":"Other: Botulinum Toxin Injections","description":"Each patient in the treatment group will receive 400 units of botulinum toxin. 100 units will be injected at adductors at each leg and 100 units will be applied in each triceps surae bilaterally."},{"intervention_type":"Other","name":"Other: Placebo Injections","description":"Each patient in the placebo group will receive sterile sodium chloride injections at adductors and triceps surae muscles bilaterally."}],"outcomes":[{"outcome_type":"primary","measure":"Change from baseline in 10 meter maximum gate velocity","time_frame":"8 weeks after injections","description":"The primary outcome measure will be change from baseline in maximum gait velocity. Each patient will be asked to walk a 10 meter distance barefooted 3 times, as fast as he can. The average velocity between the 3 trials will be used as the final measure. Assistive devices are permitted."},{"outcome_type":"secondary","measure":"Change from baseline in Spastic Paraplegia Rating Scale (SPRS),","time_frame":"8 weeks after each procedure","description":"The same neurologist will examine the patient to evaluate change at the SPRS scale"},{"outcome_type":"secondary","measure":"Change from baseline in Ashworth spasticity scale of adductors and triceps surae muscles","time_frame":"8 weeks after each procedure","description":"The same neurologist will examine the patient to evaluate change from baseline"},{"outcome_type":"secondary","measure":"Change from baseline in muscle strengh (Medical Research Council scale) concerning adductors and triceps surae muscles.","time_frame":"8 weeks after each procedure","description":"The same neurologist will examine the patient to evaluate change from baseline"},{"outcome_type":"secondary","measure":"Change from baseline in visual analogic scale of pain","time_frame":"8 weeks after each procedure","description":"this scale will be applied by a neurologic physiotherapist"},{"outcome_type":"secondary","measure":"Change from baseline in brief pain inventory scale","time_frame":"8 weeks after each procedure","description":"this scale will be applied by a neurologic physiotherapist"},{"outcome_type":"secondary","measure":"Change from baseline in modified fatigue impact scale","time_frame":"8 weeks after each procedure","description":"this scale will be applied by a neurologic physiotherapist"},{"outcome_type":"secondary","measure":"Change from baseline in 10 meter comfortable walking velocity","time_frame":"8 weeks after each procedure","description":"this scale will be applied by a neurologic physiotherapist"}]}
{"nct_id":"NCT03324919","start_date":"2016-03-01","enrollment":220,"brief_title":"Patient Centered Care Situation and Health-related Quality of Life by Patients With Psoriasis, Urticaria or Lupus","official_title":"Patient Centered Care Situation and Health-related Quality of Life of Patients From Non-urban Practice vs University Hospital With Diagnosis Psoriasis Vulgaris, Urticaria or Lupus Erythematodes","primary_completion_date":"2017-04-30","study_type":"Observational [Patient Registry]","rec_status":"Completed","completion_date":"2017-09-01","last_update":"2017-10-30","description":"This study is based on a survey about the patient centered care situation and health-related quality of life of patients with diagnoses Psoriasis, Urtikaria or Lupus erythematodes. Detection of relevant parameters of quality of life by these patients serves for the detection of psychosocial burden of the mentioned skin diseases, thus gaining an increasing importance for prospective economic issues. This survey is a behaviorally based questionnaire for patients with the above diseases and addresses activities such as sleep and rest, mobility, recreation, home management, emotional behavior, social interaction, and the like.","other_id":"UHRegensburg","observational_model":"Ecologic or Community","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":80,"population":"Patients diagnosed with Psoriasis, Urticaria or Lupus erythematodes. History for the\r\n        respective disease with the appropriate score classification by Guideline.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Voluntary consent by written and oral explanation.\r\n\r\n          -  Patients with the diseases Psoriasis, Urticaria or Lupus\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Children and adolescents < 18 years\r\n\r\n          -  pregnancy and breast feeding period of women\r\n\r\n          -  History of abuse of alcohol, drugs or other substances, or factors that limit the\r\n             ability to cooperate and compliance in the study\r\n      ","sponsor":"University Hospital Regensburg","sponsor_type":"Other","conditions":"Quality of Life","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: HRQL","description":"Intervention of patient centered care situation and health-related quality of life of patients with Psoriasis, Urticaria or Lupus erythematodes from non-urban practices vs urban practises. Identification of relevant health-related quality of life parameters of these patients."}],"outcomes":[{"outcome_type":"primary","measure":"Investigation of patient centered care situation and health-related quality of life of patients with Psoriasis, Urtikaria and Lupus erythematosus","time_frame":"24 months","description":"Detection of the quality of life score by these patients. Questionnaire administration and clinical documentation takes place when patients were present at the outpatient clinic of the Department of Dermatology, University Hospital Regensburg. Key inclusion criteria: diagnoses of psoriasis, urticaria or lupus erythematodes"},{"outcome_type":"secondary","measure":"Identification of relevant health-related quality of life parameters of these patients","time_frame":"24 months","description":"Questionnaire, that my medical care situation must be improved at all depending on my DLQI score. The DLQI-Questionnaire will be used.The questionnaires address skin-specific aspects as well as general aspects (activities of daily living, overall health-status) of quality of life."},{"outcome_type":"secondary","measure":"Evalulation of the EQ5D-5L score of patients with Psoriasis, Urtikaria and Lupus erythematosus","time_frame":"24 months","description":"EQ5D-5L Questionnaire and vas score, depending on the travel maximal distance accessing healthcare"}]}
{"nct_id":"NCT02488109","start_date":"2016-02-29","phase":"N/A","enrollment":120,"brief_title":"Study of Refeeding to Optimize iNpatient Gains","official_title":"Multi-center Randomized Controlled Trial of Refeeding in Anorexia Nervosa","primary_completion_date":"2020-04-22","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-06-03","last_update":"2021-06-24","description":"The purpose of this study is to compare the efficacy, safety, and cost-effectiveness of lower calorie refeeding versus higher calorie refeeding in hospitalized adolescents with anorexia nervosa.","other_id":"P0504491","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":12,"maximum_age":24,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  diagnosis of AN\r\n\r\n          -  atypical AN\r\n\r\n          -  no hospital admissions for the previous six months\r\n\r\n          -  meet hospitalization criteria: daytime heart rate (HR) < 50 bpm or night time HR < 45\r\n             bpm, blood pressure (BP) <90/45 mmHg, temperature < 35.6 C, or symptomatic\r\n             orthostasis defined by increase in HR > 35 bpm or decrease in systolic BP > 20 mmHg or\r\n             decrease in diastolic BP > 10 mmHg from lying to standing\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  diagnosis of bulimia nervosa [DSM-5]\r\n\r\n          -  currently in remission (as defined by weight and EDE-Q score)\r\n\r\n          -  admission for food refusal without malnutrition\r\n\r\n          -  current pregnancy\r\n\r\n          -  chronic disease (e.g. immune/endocrine disorders, pulmonary, cardiac, or renal\r\n             disease)\r\n\r\n          -  current suicidality or psychosis\r\n\r\n          -  < 60% mBMI\r\n      ","sponsor":"University of California, San Francisco","sponsor_type":"Other","conditions":"Anorexia Nervosa","interventions":[{"intervention_type":"Other","name":"Other: Higher Calorie Refeeding"},{"intervention_type":"Other","name":"Other: Lower Calorie Refeeding"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants With Clinical Remission at Different Time Points of Assessment","time_frame":"up to 12 months","description":"Clinical remission was defined as the combination of percentage mBMI and EDE-Q score at 1, 3, 6, and 12 months. This is a dichotomous variable 1/0. If participants achieve both weight recovery (defined as =>95% of median BMI for sex and age), AND psychological recovery (defined as within 1SD of community norms for EDE-Q) then they are assigned a \"1\" for achieving clinical remission. If both parameters not met then \"0\" for not remitted."},{"outcome_type":"secondary","measure":"Time to Achieve Medical Stability in Hospital","time_frame":"Inpatient hospitalization from day of admission to day of discharge, average of 10 days","description":"Medical stability was adjudicated by a 6-point clinical index: (1) 24-hour heart rate of 45 beats/min or more, (2) systolic blood pressure of 90 mm Hg or more, (3) temperature of 35.6 °C or more, (4) orthostatic increase in heart rate of 35 beats/min or less, (5) orthostatic decrease in systolic blood pressure of 20 mm Hg or less, and (6) 75% or more of mBMI for age and sex. Criteria were assessed daily; for vital signs with multiple daily measures, the most deviant value was recorded (eg, lowest heart rate). Each criterion was scored as \"1\" if met, \"0\" if unmet, and missing (not scored) if not measured. Medical stability was considered restored when all measured criteria were stable for 24 hours, allowing a maximum of 2 missing values. Additional efficacy outcomes were time to restore heart rate to 45 beats/min or more (among those with bradycardia at baseline) and weight gain (change in percentage mBMI)."},{"outcome_type":"other","measure":"Cost-effectiveness Per Adolescent Recovered","time_frame":"up to 12 months","description":"defined as total cost (direct and indirect costs)"}]}
{"nct_id":"NCT02467816","start_date":"2016-02-29","phase":"N/A","enrollment":27406,"brief_title":"Technology and Design Innovation for School Lunch","official_title":"Technology and Design Innovation to Support 21st Century School Nutrition","primary_completion_date":"2018-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-06-30","last_update":"2019-05-14","description":"This study will evaluate an innovative school lunch intervention that is designed to increase school meal participation and improve dietary intake among middle and high school students.","other_id":"2014-12-7010","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  All 7th-10th grade students at participating schools are eligible to participate in\r\n             the student survey\r\n\r\n          -  All 6th-12th grade students who eat the school lunch are eligible to participate in\r\n             plate waste data collection\r\n\r\n          -  All 7th-10th grade teachers are eligible to participate in the teacher survey\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  There are no exclusion criteria\r\n      ","sponsor":"University of California, Berkeley","sponsor_type":"Other","conditions":"Childhood Obesity","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: SmartMeal application","description":"The SmartMeal application is a smartphone application that will allow students to pre-order school meals, receive nutrition information about school meals, and provide feedback about school meals to Student Nutrition Services."},{"intervention_type":"Behavioral","name":"Behavioral: Distributed points of sale","description":"To increase points of sale for school meals (outside the cafeteria), school meals will be sold at hot and cold mobile food carts and vending machines throughout the school."},{"intervention_type":"Behavioral","name":"Behavioral: Staff wellness curriculum","description":"A wellness curriculum will be implemented that encourages teachers and staff members to eat school meals and promote them to students."}],"outcomes":[{"outcome_type":"primary","measure":"Change in school lunch participation","time_frame":"2 years","description":"Daily school lunch participation records broken down by grade, gender, and free or reduced-price meal eligibility at each school."},{"outcome_type":"secondary","measure":"Change in plate waste during lunch among students who eat school lunch","time_frame":"2 school years","description":"Individual-level waste of food components achieved through visual estimation and aggregate waste of food components achieved through weighing."},{"outcome_type":"secondary","measure":"Change in fruit consumption at lunch","time_frame":"2 school years","description":"Student survey that asks about fruits consumed at lunch yesterday"},{"outcome_type":"secondary","measure":"Change in vegetable consumption at lunch","time_frame":"2 school years","description":"Student survey that asks about vegetables consumed at lunch yesterday"},{"outcome_type":"secondary","measure":"Change in weekly fruit consumption","time_frame":"2 school years","description":"Student survey that asks about fruits consumed during a typical week"},{"outcome_type":"secondary","measure":"Change in weekly vegetable consumption","time_frame":"2 school years","description":"Student survey that asks about vegetables consumed during a typical week"},{"outcome_type":"secondary","measure":"Change in variety of fruits consumed by students at lunch","time_frame":"2 school years","description":"Student survey that asks about fruits consumed at lunch yesterday"},{"outcome_type":"secondary","measure":"Change in variety of vegetables consumed by students at lunch","time_frame":"2 school years","description":"Student survey that asks about vegetables consumed at lunch yesterday"},{"outcome_type":"secondary","measure":"Change in variety of fruits consumed by students each week","time_frame":"2 school years","description":"Student survey that asks about fruits consumed during a typical week"},{"outcome_type":"secondary","measure":"Change in variety of vegetables consumed by students each week","time_frame":"2 school years","description":"Student survey that asks about vegetables consumed during a typical week"},{"outcome_type":"secondary","measure":"Change in body mass index (index)","time_frame":"2 school years","description":"BMI data collected each year on 7th and 9th grade students via the California Physical Fitness Test"}]}
{"nct_id":"NCT02510495","start_date":"2016-02-29","phase":"N/A","enrollment":1920,"brief_title":"Effect of Endoscopic Papillary Balloon Dilation on ERCP Complications","official_title":"Effect of Different Endoscopic Papillary Balloon Dilation Duration Time on Complications of Common Bile Duct Stone Patient","primary_completion_date":"2017-11-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-11-01","last_update":"2019-01-25","description":"The purpose of this study is to determine how different endoscopic papillary balloon dilatation (EPBD) duration time affects the complications after endoscopic retrograde cholangiopancreatography (ERCP) in the treatment of common bile duct stones.","other_id":"ERCP Balloon Dilation","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age18 years\r\n\r\n          -  CBD stone patients, stone diameter1.5cm, CBD diameter2cm\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Unwillingness or inability to consent for the study\r\n\r\n          -  Coagulation dysfunction (INR> 1.3) and low peripheral blood platelet count (<50109 /\r\n             L) or using anti-coagulation drugs\r\n\r\n          -  Previous EST or EPBD\r\n\r\n          -  Prior surgery of Bismuth  and Roux-en-Y\r\n\r\n          -  Benign or malignant CBD stricture\r\n\r\n          -  Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage, severe\r\n             liver disease, primary sclerosing cholangitis (PSC), septic shock\r\n\r\n          -  Combined with Mirizzi syndrome and intrahepatic bile duct stones\r\n\r\n          -  Malignant disease\r\n\r\n          -  Biliary-duodenal fistula confirmed during ERCP\r\n\r\n          -  Pregnant women\r\n      ","sponsor":"Hepatopancreatobiliary Surgery Institute of Gansu Province","sponsor_type":"Other","conditions":"Complications","interventions":[{"intervention_type":"Procedure","name":"Procedure: 30\" group","description":"A small sphincterotomy (EST) was performed prior to the EPBD, the length of a small sphincterotomy was considered as no larger than the range which from the orifice to the top one-third of the papilla. a CRE balloon (diameter 8, 9, 10, 11, 12, 13.5, 15; Boston Scientific) was chosen according to the diameter of bile duct. It was placed across the papilla orifice and then gradually filled with diluted contrast in 15 seconds. When the waist disappeared, the balloon was inflated till 30 seconds prior deflated. The stones were then retrieved by a basket or retrieval balloon. Mechanical lithotripsy was used if necessary."},{"intervention_type":"Procedure","name":"Procedure: 60\" group","description":"A small sphincterotomy (EST) was performed prior to the EPBD, the length of a small sphincterotomy was considered as no larger than the range which from the orifice to the top one-third of the papilla. a CRE balloon (diameter 8, 9, 10, 11, 12, 13.5, 15; Boston Scientific) was chosen according to the diameter of bile duct. It was placed across the papilla orifice and then gradually filled with diluted contrast in 15 seconds. When the waist disappeared, the balloon was inflated till 60 seconds prior deflated. The stones were then retrieved by a basket or retrieval balloon. Mechanical lithotripsy was used if necessary."},{"intervention_type":"Procedure","name":"Procedure: 180\" group","description":"A small sphincterotomy (EST) was performed prior to the EPBD, the length of a small sphincterotomy was considered as no larger than the range which from the orifice to the top one-third of the papilla. a CRE balloon (diameter 8, 9, 10, 11, 12, 13.5, 15; Boston Scientific) was chosen according to the diameter of bile duct. It was placed across the papilla orifice and then gradually filled with diluted contrast in 15 seconds. When the waist disappeared, the balloon was inflated till 180 seconds prior deflated. The stones were then retrieved by a basket or retrieval balloon. Mechanical lithotripsy was used if necessary."},{"intervention_type":"Procedure","name":"Procedure: 300\" group","description":"A small sphincterotomy (EST) was performed prior to the EPBD, the length of a small sphincterotomy was considered as no larger than the range which from the orifice to the top one-third of the papilla. a CRE balloon (diameter 8, 9, 10, 11, 12, 13.5, 15; Boston Scientific) was chosen according to the diameter of bile duct. It was placed across the papilla orifice and then gradually filled with diluted contrast in 15 seconds. When the waist disappeared, the balloon was inflated till 300 seconds prior deflated. The stones were then retrieved by a basket or retrieval balloon. Mechanical lithotripsy was used if necessary."}],"outcomes":[{"outcome_type":"primary","measure":"Post-ERCP pancreatitis","time_frame":"Within 7 days after ERCP","description":"Upper abdominal pain with serum amylase elevation no less than 462 U/L after the procedure"},{"outcome_type":"secondary","measure":"Hemorrhage","time_frame":"Within 7 days after ERCP","description":"Maintained positive fecal occult blood test appears"},{"outcome_type":"secondary","measure":"Perforation","time_frame":"Within 7 days after ERCP","description":"CT scan shows retroperitoneal space fluid or gas"},{"outcome_type":"secondary","measure":"Acute cholangitis","time_frame":"Within 7 days after ERCP","description":"Intermittent chills and fever after ERCP"},{"outcome_type":"secondary","measure":"Pain","time_frame":"Within 7 days after ERCP","description":"Upper abdominal pain after ERCP measured by Numerical Rating Scale"},{"outcome_type":"secondary","measure":"Operation time","time_frame":"Up to 2 hours","description":"From successful biliary intubation to end of operation"},{"outcome_type":"secondary","measure":"Average hospital stay","time_frame":"Up to 30 days","description":"Length of stay in hospital"},{"outcome_type":"secondary","measure":"Stone clearance rate","time_frame":"Up to 2 hours","description":"The proportion of patients with all stones removed"},{"outcome_type":"secondary","measure":"Success rate of stone extraction in the initial attempt","time_frame":"Up to 2 hours","description":"The proportion of patients with all stones removed in first attempt after EPBD"},{"outcome_type":"secondary","measure":"Rate of mechanical lithotripsy","time_frame":"Up to 2 hours","description":"The proportion of patients whose stones need mechanical lithotripsy before removed"},{"outcome_type":"secondary","measure":"X-ray exposure time","time_frame":"Up to 2 hours","description":"The total radiography time during ERCP"},{"outcome_type":"secondary","measure":"Pancreatic duct insertion times","time_frame":"Up to 2 hours","description":"Times of any accessories goes into the pancreatic duct, no matter how depth"}]}
{"nct_id":"NCT02754388","start_date":"2016-02-29","enrollment":1334,"brief_title":"Early Detection of Lung Cancer With Low-dose Multislice Computed Tomography","official_title":"Early Detection of Lung Cancer With Low-dose Multislice Computed Tomography (LDCT)- a Screening Program","primary_completion_date":"2017-05-31","study_type":"Observational [Patient Registry]","rec_status":"Completed","completion_date":"2019-12-31","last_update":"2020-02-28","description":"Lung cancer is one of the leading causes of cancer-related death in Taiwan. Early diagnosis of lung cancer may improve cancer survival. Low-dose computed tomography (LDCT) was thought to be the best screening tool for lung cancer. However, there is growing concerns about radiation exposure, high cost, and high rate of false-positive screening result. Epidemiologic studies from western countries showed that cigarette smoking is the major cause of lung cancer, and other risk factors may include age, environmental pollution, occupational exposures (included of radon exposure), gender, race, and pre-existing lung diseases. Adenocarcinoma is the major type of lung cancer in Taiwan and is less attributable to smoking. The investigators need a different risk prediction model adapted to the investigators country. National Taiwan University Hospital Chu-Tung Branch initiated the lung cancer screening by LDCT since June 2015. Many people can get the LDCT screening with affordable price with the subsidy from enterprise donation. The purpose of this study is observing those participants with 2-year follow-up. Furthermore, those data may connect with another study of \"Low dose computed tomography screening study in nonsmoker with risk factors for lung cancer in Taiwan\" Non-smoker studywhich is implemented in other hospitals in Taiwan.For reality limiting, After one year, the enrollment rate was a lot lower than expected. We extended the enrollment time but only observe those participants for one year not two year..","other_id":"201512060RIND","observational_model":"Case-Only","time_perspective":"Other","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":20,"population":"Patients received LDCT screening at NTUH Chu-Tung Branch","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  age>=20\r\n\r\n          -  self pay the LDCT in National Taiwan University Hospital Chu-Tung Branch\r\n\r\n          -  ability to understand the informed consent form for complete the questionnaires\r\n\r\n          -  be willing and able to accept telephone access at the time scheduled\r\n\r\n        Exclusion Criteria:\r\n\r\n        NA\r\n      ","sponsor":"National Taiwan University Hospital","sponsor_type":"Other","conditions":"Lung Cancer","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Abnormal ct finding detection rate","time_frame":"1-month","description":"Abnormal ct finding detection rate is defined as number of abnormal ct finding/total enroll number"},{"outcome_type":"secondary","measure":"Change in Chinese 14-item Perceived Stress Scale (Chinese 14-item PSS) score","time_frame":"6-month","description":"Stress will be measured using the Chinese 14-item Perceived Stress Scale (Chinese 14-item PSS) at baseline and 6 month follow-up."},{"outcome_type":"secondary","measure":"Change in Chinese Health Questionnaire-12 (CHQ-12) score","time_frame":"12-month","description":"Psychological morbidity will be measured using the Chinese Health Questionnaire (CHQ-12) at baseline and 12 month follow-up."}]}
{"nct_id":"NCT02703428","start_date":"2016-02-29","enrollment":30,"brief_title":"TriVascular Evaluation of Females Who Are Underrepresented Candidates for Abdominal Aortic Aneurysm Repair in Europe","official_title":"The LUCY Study: TriVascular Evaluation of Females Who Are Underrepresented Candidates for Abdominal Aortic Aneurysm Repair in Europe","primary_completion_date":"2019-02-28","study_type":"Observational","rec_status":"Completed","completion_date":"2019-05-31","last_update":"2021-06-08","description":"The LUCY Study is a prospective, consecutively enrolling, non-randomized multi center post-market study to evaluate the low profile (14F) Ovation Abdominal Stent Graft Platform when used in the endovascular treatment of female patients.","other_id":"771-0019","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"Female","minimum_age":18,"population":"The study will enroll female subjects, 18 years of age or older that have an AAA and meet\r\n        all other inclusion/exclusion criteria","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patient is > 18 years of age.\r\n\r\n          2. Patients who are non-pregnant female (females of child bearing potential must have a\r\n             negative pregnancy test prior to enrollment into the study).\r\n\r\n          3. Patient has signed an Ethics Committee (EC) approved Informed Consent Form.\r\n\r\n          4. Patient is considered by the treating physician to be a candidate for elective open\r\n             surgical repair of the AAA (i.e., category I, II, or III per American Society of\r\n             Anesthesiology (ASA) classification). ASA category IV patients may be enrolled\r\n             provided their life expectancy is greater than 1 year.\r\n\r\n          5. Patient has an infrarenal abdominal aortic aneurysm that meets at least one of the\r\n             following:\r\n\r\n               -  Abdominal aortic aneurysm >5.0 cm in diameter;\r\n\r\n               -  Aneurysm has increased in size by 0.5 cm in last 6 months; or\r\n\r\n               -  Maximum diameter of aneurysm exceeds 1.5 times the transverse dimension of an\r\n                  adjacent non-aneurysmal aortic segment.\r\n\r\n          6. Patient has suitable anatomy that allows use of the TriVascular Ovation Abdominal\r\n             Platform:\r\n\r\n               -  Iliac or femoral arteries that allow endovascular access with the TriVascular\r\n                  Ovation Abdominal Platform.\r\n\r\n               -  Proximal aortic neck landing zone with an inner wall diameter of no less than 16\r\n                  mm and no greater than 30 mm at 13 mm below the inferior renal artery.\r\n\r\n               -  Distal iliac artery landing zone length (seal zone) of 10 mm. The resultant\r\n                  repair should preserve patency in at least one hypogastric artery.\r\n\r\n               -  Distal iliac artery landing zone an inner wall diameter of no less than 8 mm and\r\n                  no greater than 25 mm.\r\n\r\n               -  Distance from the most distal renal artery to most superior internal iliac artery\r\n                  measurement is at least 130 mm.\r\n\r\n               -  Aortic angle of  60 degrees if proximal neck length is 10 mm and  45 degrees\r\n                  if proximal neck length is <10 mm.\r\n\r\n          7. Patient must be willing to comply with all required follow-up exams.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patient has a need for emergent surgery.\r\n\r\n          2. Patient has a dissecting aneurysm.\r\n\r\n          3. Patient has an acutely ruptured aneurysm.\r\n\r\n          4. Patient has an acute vascular injury.\r\n\r\n          5. Patient has had a previous repair of the abdominal aortic aneurysm or an iliac artery\r\n             in intended treatment zone.\r\n\r\n          6. Patient has a known thoracic aortic aneurysm or dissection that will require treatment\r\n             (surgery or endovascular intervention) within the study period.\r\n\r\n          7. Patient has a mycotic aneurysm or has an active systemic infection.\r\n\r\n          8. Patient has unstable angina (defined as angina with a progressive increase in\r\n             symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina).\r\n\r\n          9. Patient has had a myocardial infarction (MI) and/or stroke (CVA) within the past 6\r\n             months.\r\n\r\n         10. Patient requires use of techniques (e.g. Chimney graft) that would cover the renal\r\n             arteries.\r\n\r\n         11. Patient requires planned adjunctive devices (e.g. renal stents) to complete the\r\n             procedure.\r\n\r\n         12. Patient has a major surgical or interventional procedure planned during or within 30\r\n             days of the AAA repair.\r\n\r\n         13. Patient has history of connective tissue disease (e.g., Marfan's or Ehler's-Danlos\r\n             syndrome).\r\n\r\n         14. Patient has history of bleeding disorders or refuses blood transfusions.\r\n\r\n         15. Patient has dialysis dependent renal failure or baseline serum creatinine level >2.0\r\n             mg/dl\r\n\r\n         16. Patient has a known hypersensitivity or contraindication to anticoagulation or\r\n             contrast media that is not amenable to pre-treatment.\r\n\r\n         17. Patient has a known allergy or intolerance to polytetrafluoroethylene (PTFE),\r\n             PEG-based polymers, fluorinated ethylene propylene (FEP) or nitinol.\r\n\r\n         18. Patient has a body habitus that would inhibit X-ray visualization of the aorta.\r\n\r\n         19. Patient has a limited life expectancy of less than 1 year.\r\n\r\n         20. Patient is currently participating in an investigational device or drug clinical\r\n             trial.\r\n\r\n         21. Patient has other medical, social or psychological conditions that, in the opinion of\r\n             the investigator, preclude them from receiving the pre-treatment, required treatment,\r\n             and post-treatment procedures and evaluations.\r\n      ","sponsor":"TriVascular, Inc.","sponsor_type":"Industry","conditions":"Abdominal Aortic Aneurysm","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Freedom from access-related vascular complications and freedom from AAA-related mortality through 30 days.","time_frame":"30 ± 10 days"},{"outcome_type":"secondary","measure":"Serious and Non-Serious Adverse Events","time_frame":"365 ± 60 days"},{"outcome_type":"secondary","measure":"Access-related vascular complications","time_frame":"365 ± 60 days"},{"outcome_type":"secondary","measure":"Technical (deployment) success","time_frame":"365 ± 60 days","description":"Defined as successful delivery and deployment of one aortic body and at least two iliac limbs."},{"outcome_type":"secondary","measure":"Freedom from Type I & III endoleaks","time_frame":"365 ± 60 days"},{"outcome_type":"secondary","measure":"Freedom from migration","time_frame":"365 ± 60 days"},{"outcome_type":"secondary","measure":"Freedom from aneurysm enlargement","time_frame":"365 ± 60 days"},{"outcome_type":"secondary","measure":"Freedom from Abdominal Aortic Aneurysm rupture","time_frame":"365 ± 60 days"},{"outcome_type":"secondary","measure":"Freedom from conversion to open repair","time_frame":"365 ± 60 days","description":"Conversion to open surgical repair occurs when a subject implanted with an Ovation Abdominal Platform undergoes open surgical repair with explantation of the stent graft."},{"outcome_type":"secondary","measure":"Freedom from AAA related secondary interventions","time_frame":"365 ± 60 days"},{"outcome_type":"secondary","measure":"Freedom from mortality (all cause and AAA related)","time_frame":"365 ± 60 days"},{"outcome_type":"secondary","measure":"Blood Loss","time_frame":"365 ± 60 days","description":"Estimate blood loss and replacement requirements, (e.g. transfusion)."},{"outcome_type":"secondary","measure":"Duration of Procedure","time_frame":"365 ± 60 days","description":"Time enter procedure room, time start arterial access, stent graft deployment start and stop time, time of closure of arterial access, and time exit procedure room."},{"outcome_type":"secondary","measure":"Length of hospital and ICU (if required)","time_frame":"365 ± 60 days"},{"outcome_type":"secondary","measure":"Anesthesia Type","time_frame":"365 ± 60 days"}]}
{"nct_id":"NCT02676700","start_date":"2016-02-29","phase":"N/A","enrollment":41,"brief_title":"Pelvic Floor Muscle Training and Kaatsu Training for Women With Stress Urinary Incontinence","official_title":"The Effect of Pelvic Floor Muscle Training With or Without Kaatsu Training for Women With Stress Urinary Incontinence","primary_completion_date":"2017-07-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-08-01","last_update":"2018-02-22","description":"This study examines the effect of adding so called Kaatsu training to pelvic floor muscle training. Half the participants will perform Kaatsu training on their thigh muscles followed by pelvic floor muscle training. The other half will receive pelvic floor muscle training alone.","other_id":"H-2-2013-125","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  ICIQ-SF  12\r\n\r\n          -  Urinary stress incontinence\r\n\r\n          -  Ability to contract pelvic floor muscles\r\n\r\n          -  Normal bladder capacity and normal flow during micturition with at least one\r\n             micturition of > 350 ml\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Urgency urinary incontinence\r\n\r\n          -  Cognitive problems\r\n\r\n          -  Physical inability to perform Kaatsu program\r\n\r\n          -  Inability to understand and read Danish\r\n      ","sponsor":"Herlev Hospital","sponsor_type":"Other","conditions":"Urinary Stress Incontinence","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Pelvic floor muscle training and Kaatsu","description":"The intervention includes three outpatient visits (weeks 0, 6 and 12) and between visits the participants perform PFMT and Kaatsu training as home training"},{"intervention_type":"Behavioral","name":"Behavioral: Pelvic floor muscle training","description":"The intervention includes three outpatient visits (weeks 0, 6 and 12) and between visits the participants perform PFMT as home training"}],"outcomes":[{"outcome_type":"secondary","measure":"PGI-I (Patient Global Index of Improvement scale)","time_frame":"6 and 12 weeks","description":"Global scale"},{"outcome_type":"secondary","measure":"UPR (Urethral Pressure Reflectometry)","time_frame":"12 weeks","description":"UPR is a novel method measuring the pressure and the cross-sectional area of the female urethra. The difference in urethral opening pressure during pelvic floor muscle contraction before and after intervention is measured in cm H2O"},{"outcome_type":"primary","measure":"ICIQ-SF (International Consultation on Incontinence Questionnaire - Short Form )","time_frame":"12 weeks","description":"Subjective measure of severity of urinary loss and impact on quality of life"},{"outcome_type":"secondary","measure":"ICIQ-SF","time_frame":"6 weeks","description":"Subjective measure of severity of urinary loss and impact on quality of life"},{"outcome_type":"secondary","measure":"Three days bladder diary","time_frame":"6 and 12 weeks","description":"Diary to report number of incontinence episodes"},{"outcome_type":"secondary","measure":"VAS (Visual Analog Scale)","time_frame":"6 and 12 weeks","description":"Scale used to report bother with performing the interventions"}]}
{"nct_id":"NCT02692612","start_date":"2016-02-29","enrollment":80,"brief_title":"Effects of Power-velocity Muscle Characteristics During Ageing","primary_completion_date":"2016-07-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2016-07-31","last_update":"2016-02-26","description":"The purpose of this project is to investigate the age-related differences in force-velocity muscle characteristics during isolated knee extensions variable in speed and load, during cyclic movements on a usual and recumbent bike variable in speed and velocity development and a functional test battery with healthy participants aged between 20-80 years.","other_id":"s58633","observational_model":"Cohort","time_perspective":"Cross-Sectional","sampling_method":"Probability Sample","gender":"All","minimum_age":20,"maximum_age":80,"population":"young (20-40y) middle-aged (40-60y) old (60-80y)","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  healthy volunteers age 20 to 80 years\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Knee or hip prothesis\r\n\r\n          -  Systematic training\r\n\r\n          -  Cardiovascular disease\r\n\r\n          -  Acute lower back pain\r\n\r\n          -  Acute knee pain\r\n\r\n          -  Dementia\r\n      ","sponsor":"Universitaire Ziekenhuizen Leuven","sponsor_type":"Other","conditions":"Sarcopenia","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Differences in power-velocity characteristics during ageing","time_frame":"1x at baseline (cross sectional study)","description":"peak power and rate of power development (slope) at different velocities during knee extension movement and cyclic multijoint leg press movement compared between young and old people"},{"outcome_type":"secondary","measure":"Reliability of strength tests on regular and recumbent bike.","time_frame":"1x at baseline (cross sectional study)","description":"reliability of peak power and rate of power development outcomes measured twice within a period of 2 weeks"},{"outcome_type":"secondary","measure":"Differences in muscle fascicle characteristics during ageing.","time_frame":"1x at baseline (cross sectional study)","description":"Differences between young and old people of fascicle shortening velocity during dynamic leg press movements measured via dynamic ultrasound"},{"outcome_type":"secondary","measure":"Differences in muscle activation during ageing.","time_frame":"1x at baseline (cross sectional study)","description":"Differences in muscle activation pattern during dynamic leg press movements measured via muscle electromyography"}]}
{"nct_id":"NCT01868880","start_date":"2016-02-29","phase":"Phase 4","enrollment":0,"brief_title":"Effect of Ivabradine and Beta-blockers Combination Versus Beta-blockers Up-titration on Right Ventricular Pacing","official_title":"Effect of Heart Rate Control Using Ivabradine and Beta-blockers Combination Versus Beta-blockers Up-titration on Ventricular Pacing in Heart Failure Patients With an Implanted Cardioverter Defibrillator.","primary_completion_date":"2023-12-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2023-12-31","last_update":"2020-03-13","description":"The aim of this prospective, randomized and controlled trial is to evaluate the use of the ivabradine in combination to a low-dose of beta-blocker (bisoprolol) versus up-titration of beta-blocker (bisoprolol) to obtain heart rate (HR) control with reduction in RV pacing in single-chamber or dual chambers ICD recipients HF patients with moderate to severe left ventricular dysfunction (FE  40%) and an heart rate  70 bpm in sinus rhythm over a 12-months follow up. Besides the investigators want to assess if the combination of ivabradine to a low-dose of beta-blocker (bisoprolol) versus up-titration of beta-blocker (bisoprolol) may determine a lower degree of left ventricular dysfunction progression, the reduction of ventricular arrhythmias burden and ICD appropriate therapy occurrence and the improvement of quality of life in ICD heart failure patients.","other_id":"calo03","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":95,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Age  18 years.\r\n\r\n        Patients with stable chronic heart failure implanted with mono-cameral or bicameral ICD\r\n        with a home monitoring remote control.\r\n\r\n        Moderate to severe left ventricular dysfunction (FE  40%).\r\n\r\n        Any cause of heart failure was allowed apart congenital heart disease.\r\n\r\n        Bicameral ICD programmed in DDD or AAI/DDD with AV interval < 300 msec.\r\n\r\n        Rest ECG heart rate 70 bpm;\r\n\r\n        Sinus rhythm.\r\n\r\n        In therapy with low-dose of beta-blocker (bisoprolol 1,25-2,5 mg) and with the maximum dose\r\n        tolerated of angiotensin-converting enzyme inhibitor or blockade of angiotensin II\r\n        receptor, mineralocorticoid antagonist, antiplatelet and lipid-lowering therapy, unless\r\n        contraindicated.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Inability of providing informed consent;\r\n\r\n        Age < 18 years.\r\n\r\n        State of pregnancy or lactation.\r\n\r\n        Recent (<2 months) myocardial infarction;\r\n\r\n        Contraindications to beta-blockers and ivabradine;\r\n\r\n        Rest ECG heart rate < 70 bpm;\r\n\r\n        No sinus rhythm.\r\n\r\n        Administration of non-dihydropyridinic calcium channels antagonists, digitalis, class I\r\n        antiarrhythmic drugs, strong inhibitors of cytochrome P450 3A4 at the time of enrollment.\r\n      ","sponsor":"Policlinico Casilino ASL RMB","sponsor_type":"Other","conditions":"Heart Rate Control in ICD Patients With Heart Failure","interventions":[{"intervention_type":"Drug","name":"Drug: Ivabradine plus beta-blocker (bisoprolol)","description":"Ivabradine will be administered at a dose of 5 mg twice daily in addition to a low dose of beta-blocker (bisoprolol 1,25 or 2,5 mg). After four weeks of treatment ivabradine will be eventually lowered up to 2,5 mg twice daily in the presence of side effects (phosphenes, diplopia, headache or dizziness)."},{"intervention_type":"Drug","name":"Drug: betablocker titration","description":"Beta blocker Bisoprolol will be up-titrated biweekly starting from the initial dose of 1,25-2,5 mg daily up to the max dose of 10 mg daily or to the maximum tolerated dose."}],"outcomes":[{"outcome_type":"primary","measure":"Right ventricular pacing percentage increase > 50% or cardiovascular death or Heart failure decompensation or Crossover due to worsening heart failure.","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Number of episodes of non-sustained and sustained ventricular tachycardia and ventricular fibrillation","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Number of ICD shock-delivery for ventricular fibrillation and sustained ventricular tachycardia","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Ejection fraction decrease < 5% from baseline value","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Left Ventricular End-Systolic Volume decrease <15% from baseline value","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Heart rate variability increase (> 10%) from baseline value","time_frame":"12 months"},{"outcome_type":"secondary","measure":"reduction of at least one NYHA Class from baseline value","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Change in Minnesota Living Heart Failure Questionnaire scores (>5) from the baseline score.","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Right ventricular pacing percentage reduction (> 10%) from baseline value","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Composite endpoint: number of cardiovascular death and hospitalization due to worsening heart failure.","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Crossover rate due to worsening heart failure","time_frame":"12 months"}]}
{"nct_id":"NCT02461602","start_date":"2016-02-29","enrollment":251,"brief_title":"Eliminate Thromboembolism: Improving Anticoagulation in Non-valvular Atrial Fibrillation Patients","official_title":"Eliminate Thromboembolism (ELITE): Improving Anticoagulation in Non-valvular Atrial Fibrillation Patients","primary_completion_date":"2018-05-31","study_type":"Observational [Patient Registry]","rec_status":"Completed","completion_date":"2018-05-31","last_update":"2019-04-09","description":"ELITE (Eliminate Thromboembolism: Improving Anticoagulation in Non-valvular Atrial Fibrillation Patients) is a two year research project to assess warfarin management issues faced by atrial fibrillation (AF) patients in ambulatory settings.","other_id":"Pro00061054","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"Atrial Fibrillation patients","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18 years or older at the time of enrollment\r\n\r\n          -  Electrocardiographically confirmed AF\r\n\r\n          -  Able to complete patient-reported outcomes surveys\r\n\r\n          -  Initiated warfarin therapy in the prior 3 months\r\n\r\n          -  Ability to adhere to regular clinical visits\r\n\r\n          -  Ability to sign informed consent\r\n\r\n          -  Ability to read/comprehend/speak English\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Anticipated life expectancy less than six months (as determined by the site\r\n             investigator)\r\n\r\n          -  Transient AF secondary to a reversible condition (hyperthyroidism, pulmonary embolism,\r\n             post-cardiothoracic surgery)\r\n\r\n          -  Recent Deep Venous Thrombosis(DVT) or Pulmonary Embolism (PE) (within 6 months)\r\n\r\n          -  Participation in a randomized trial of anticoagulation for AF\r\n\r\n          -  Use of a home international normalized ratio (INR) monitoring system\r\n      ","sponsor":"Duke University","sponsor_type":"Other","conditions":"Atrial Fibrillation","interventions":{},"outcomes":[{"outcome_type":"secondary","measure":"Change in INR values","time_frame":"Baseline and 6 months"},{"outcome_type":"primary","measure":"Reason(s) for Warfarin discontinuation","time_frame":"6 months"},{"outcome_type":"primary","measure":"Change in Warfarin adherence","time_frame":"Baseline and 6 months"},{"outcome_type":"secondary","measure":"Frequency of hospitalizations","time_frame":"Baseline and 6 months"},{"outcome_type":"secondary","measure":"Frequency of bleeding events","time_frame":"Baseline and 6 months"}]}
{"nct_id":"NCT02744885","start_date":"2016-02-29","phase":"N/A","enrollment":67,"brief_title":"Crave Crush Behavioral Study","official_title":"Crave Crush: Sugar Cravings and ad Lib Candy Uptake","primary_completion_date":"2016-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-04-30","last_update":"2018-07-19","description":"The purpose of the research is to determine if participants who take \"Crave Crush\" will report lower cravings and palatability ratings of candy as compared to subjects who receive the placebo. Participants are self-selected university students who pass our table and verbally agree to participate in a research study about taste preferences. Data will be recorded anonymously.","other_id":"FOUR001","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"Single","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  University student, having eaten within the last hour, having slept within two hours\r\n             of their normal amount\r\n\r\n        Exclusion Criteria:\r\n\r\n        -\r\n      ","sponsor":"Oregon Research Behavioral Intervention Strategies, Inc.","sponsor_type":"Industry","conditions":"Obesity","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Crave Crush","description":"Crave Crush is a dietary supplement that affects sweet taste receptors on the tongue."},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Placebo Comparator: Placebo","description":"The placebo tablet is comparable in taste and is comprised primarily of sorbitol."}],"outcomes":[{"outcome_type":"primary","measure":"Self-Reported Craving Reduction","time_frame":"10 minutes"},{"outcome_type":"secondary","measure":"Self-Reported Palatability Reduction","time_frame":"10 minutes"}]}
{"nct_id":"NCT02406729","start_date":"2016-02-29","phase":"Phase 3","enrollment":16944,"brief_title":"Phase III Trial to Evaluate Efficacy and Safety of a Tetravalent Dengue Vaccine","official_title":"Phase III Trial to Evaluate Efficacy and Safety of a Dengue 1,2,3,4 (Attenuated) Vaccine","primary_completion_date":"2021-08-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2024-08-31","last_update":"2021-02-04","description":"This is a randomized, multicenter, double-blind, placebo-controlled Phase III study that will evaluate efficacy and safety of a live attenuated, tetravalent, lyophilized dengue vaccine produced by Butantan Institute. The study will be carried out in multiple sites in Brazil. The study will be community-based in select urban areas where there's dengue transmission. Study's intervention will be a single dose of the tetravalent dengue vaccine or placebo in a ratio 2:1. For efficacy analysis will be considered all dengue cases occurring after 28 days post-vaccination in the entire population of 16944 participants. For safety analysis participants will be divided in three age groups: 18 to 59 ys, 7-17 ys and 2 to 6 ys. In each of these age groups there will be a minimum of 4992 participants. The age groups of 18 to 59 ys and 7 to 17 ys will start first. Once safety data for the first 21 days after vaccination is analysed for 450 participants in 7-to17-ys age group, the following group, of 2 to 6 ys, will start. The study's hypothesis is that the vaccine under investigation and produced by Butantan Institute is safe and provides protection against dengue symptomatic disease of 80% or more with a lower bound of the 95% confidence interval of 25%. This way, the expected number of dengue cases virologically confirmed is 24 or more which will provide a response in terms of vaccine efficacy. All participants will be followed up for five years to verify dengue incidence, regardless severity.","other_id":"DEN-03-IB","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":2,"maximum_age":59,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Children who have completed 24 months of age, adolescents and adults who have not\r\n             completed 60 years of age;\r\n\r\n          2. Agree with periodic contacts, either/or by phone, electronic means, and home visits.\r\n\r\n          3. Show voluntary intention to participate in the study, documented by the participant's\r\n             or participant's legal representative's signature of the informed consent form.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. For women: Pregnancy (confirmed by positive beta-hCG test) or breastfeeding;\r\n\r\n          2. Evidence of active neurological, cardiac, pulmonary, hepatic or renal disease as per\r\n             clinical history and/or physical examination;\r\n\r\n          3. Compromised immune system diseases including: decompensated diabetes mellitus, cancer\r\n             (except basal cell carcinoma), congenital or acquired immune deficiencies and not\r\n             controlled autoimmune, as per clinical history and/or physical examination;\r\n\r\n          4. Behavioral, cognitive or psychiatric disease that in the opinion of the principal\r\n             investigator or his representative physician, affects the participant ability to\r\n             understand and cooperate with all study protocol requirements;\r\n\r\n          5. Abusive usage of alcohol or drugs in the past 12 months that has caused medical,\r\n             professional or family problems, indicated by clinical history;\r\n\r\n          6. History of severe allergic reactions or anaphylaxis to the vaccine or to components of\r\n             the vaccine in study;\r\n\r\n          7. History of asplenia;\r\n\r\n          8. Use of any investigational product within 28 days before or after receiving this study\r\n             vaccination;\r\n\r\n          9. Has participated in another clinical trial six months prior to inclusion in the study\r\n             or planning to participate in another clinical trial within 2 years following\r\n             inclusion;\r\n\r\n         10. Use of immunosuppressant drugs such as: antineoplastic chemotherapy, radiation\r\n             therapy, immunosuppressants to induce tolerance to transplants, and corticosteroids\r\n             use (except topical or nasal). For this protocol will be considered for exclusion use\r\n             of corticosteroids 3 months prior to the inclusion in the study and 6 months prior to\r\n             the inclusion for the other therapies mentioned, and planned use of any\r\n             immunosuppressant therapy within 2 years following inclusion in the study. It will be\r\n             considered immunosuppressive dose of corticosteroids the equivalent to a dose 20 mg\r\n             of prednisone per day for adults and the equivalent of prednisone at 2 mg/kg/day for\r\n             children for over 7 days;\r\n\r\n         11. Have received blood products in the past three months, including transfusions or\r\n             immunoglobulin, or scheduled administration of blood products or immunoglobulin for\r\n             the following 2 years after vaccination;\r\n\r\n         12. Fever or suspected fever within 72 hours prior to vaccination or axillary temperature\r\n             greater than 37,8C on the day of vaccination (inclusion might be postponed until\r\n             participant has completed 72 hours of no fever);\r\n\r\n         13. Have received live virus vaccine within 28 days or killed virus vaccine in the last 14\r\n             days prior to vaccination, or have a scheduled immunization during the first 28 days\r\n             after receiving the investigational product;\r\n\r\n         14. Any other condition that might put in risk the safety/rights of a potential\r\n             participant or hurdle his/her compliance with this protocol in investigator's opinion\r\n             or his representative physician.\r\n      ","sponsor":"Butantan Institute","sponsor_type":"Other","conditions":"Dengue","interventions":[{"intervention_type":"Biological","name":"Biological: Dengue 1,2,3,4 (attenuated) vaccine","description":"Dose 1000 PFU per virus (1,2,3,4) Route:subcutaneous"},{"intervention_type":"Other","name":"Other: Placebo","description":"Route:subcutaneous"}],"outcomes":[{"outcome_type":"primary","measure":"Efficacy (incidence density of symptomatic dengue cases, virologically confirmed)","time_frame":"at 52 weeks post vaccination, all cases after 28 days post-vaccination","description":"• The primary efficacy outcome is incidence density of symptomatic dengue cases, virologically confirmed, after 28 days post-vaccination. Virological confirmation might be done by viral isolation, RT-PCR and/or detection of NS1."},{"outcome_type":"primary","measure":"Safety (adverse reactions)","time_frame":"in the first 21 days post-vaccination","description":"• The primary safety outcome is the frequency of local and systemic adverse reactions, solicited and non-solicited in the three age groups, within the first 21 days post-vaccination. Adverse reactions are defined as adverse events that have a reasonable causal relationship with vaccination."}]}
{"nct_id":"NCT02639208","start_date":"2016-02-08","phase":"N/A","enrollment":47,"brief_title":"Novel Social Media Intervention For Older Br CA Patients","official_title":"Improving Support for Older Patients Receiving Neo/Adjuvant Chemotherapy for Breast Cancer Using a Novel Social Media Intervention","primary_completion_date":"2019-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2021-08-06","last_update":"2021-08-20","description":"The number of patients 60 and older with breast cancer is increasing as our population ages. Despite the fact that the majority of breast cancers occur in patients 60 and over, these patients are consistently under-represented in clinical trials. Because patients 60 and older are an under-studied group, investigators do not have detailed information on the side effects and experiences for these patients receiving chemotherapy. Understanding the side effects patients receiving chemotherapy experience is an important part of this study. In addition, past research has shown that having poor social support can affect quality of life, mood, and outcomes for people with cancer. However, few studies in the past have focused on improving the quality of life and support systems that patients have while they receive treatment. This research study is evaluating how engaging in an online support community may improve the experience of older patients receiving chemotherapy.","other_id":"15-326","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Participants must be women 60 years age with histologically or cytologically\r\n             confirmed, stage I-III breast cancer with a treatment plan that includes any\r\n             neoadjuvant or adjuvant chemotherapy(either in the context of standard treatment or a\r\n             clinical trial and including chemotherapy, treatments targeting the human epidermal\r\n             growth factor receptor protein 2 [HER2]), hormonal therapy or radiation.\r\n\r\n          -  Enrollment must occur according to one of the following: (1) For those receiving\r\n             chemotherapy/infusional therapy, patients must enroll during the 4 weeks prior to or\r\n             on the day of treatment initiation, (2) For those enrolling during hormonal therapy\r\n             and/or radiation, patients must enroll within 6 months of diagnosis of breast cancer,\r\n             defined as the date of initial biopsy. Patient may be receiving hormonal therapy,\r\n             radiation therapy, or both at the same time of enrollment, (3) Patients who did not\r\n             enroll during their chemotherapy are still eligible to enroll during subsequent\r\n             hormonal therapy or radiation as long as it is within 6 months of diagnosis.\r\n\r\n          -  Participants must be approached before start of treatment. Patients must be able to\r\n             understand, read, and write in English and be able to understand and have willingness\r\n             to sign a written informed consent document.\r\n\r\n          -  Patients are eligible regardless of ECOG performance status, life expectancy or,\r\n             organ/marrow function.\r\n\r\n          -  Patients must have the ability to access the internet at least once per week, and this\r\n             can occur in the patient's home, relatives' homes, work setting, or Dana-Farber (in\r\n             addition to coffee shops, libraries, etc if applicable). Having a computer is not\r\n             required. An iPad will be provided to any patient who needs one for the duration of\r\n             the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with metastatic breast cancer are not eligible to participate.\r\n\r\n          -  Participants who have started their treatment plan are not eligible.\r\n\r\n          -  Those unable to understand, read, or write in English are not eligible.\r\n\r\n          -  Men are not eligible for this study.\r\n      ","sponsor":"Dana-Farber Cancer Institute","sponsor_type":"Other","conditions":"Breast Cancer Stage I|Breast Cancer Stage II|Breast Cancer Stage III","interventions":[{"intervention_type":"Other","name":"Other: PatientsLikeMe (PLM)"}],"outcomes":[{"outcome_type":"primary","measure":"Feasibility/ Rate of Participant Login - PLM","time_frame":"4-6 months","description":"We will describe the degree of patient use of the PLM platforms and the associations of short and longer term PLM use with patient characteristics"},{"outcome_type":"secondary","measure":"Rate of Usability of PLM","time_frame":"6 Months","description":"Usability (how useful they found PLM, what parts of the site they used, etc.) will be assessed using a patient experience survey at the end of the study"},{"outcome_type":"secondary","measure":"Rate of Overall Satisfaction with PLM","time_frame":"6 Months","description":"Satisfaction with the PLM experience wil be assessed using a 'patient experience' survey at the end of the study"},{"outcome_type":"secondary","measure":"Rate of Desirability with PLM","time_frame":"6 Months","description":"Desirability (how much they enjoyed using PLM, etc) wil be assessed using a patient experience survey at the end of the study"}]}
{"nct_id":"NCT03957798","start_date":"2016-02-05","phase":"N/A","enrollment":80,"brief_title":"Evaluation of a Motion-Activated Refusal-Skills Training Video Game for Prevention of Substance Use Disorder Relapse","official_title":"Evaluation of a Motion-Activated Refusal-Skills Training Video Game for Prevention of Substance Use Disorder Relapse","primary_completion_date":"2016-06-21","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-10-31","last_update":"2019-05-21","description":"The project proposes to continue the development of an intervention for relapse prevention in the form of a professional quality video game which rewards drug-rejecting physical motions and spoken refusal phrases. Phase I research findings showed that youth in recovery experienced increased low craving levels, strong levels of satisfaction, and interest in attending treatment sessions where the intervention is available - an important outcome since failure to attend treatment is highly correlated with relapse. In Phase II, the investigators propose to modify and expand the prototype based on customer feedback from treatment centers, counselors and patients. The investigators will test the effectiveness of the motion and voice-controlled game in a randomized controlled trial of youths in treatment for opioid use disorder who have access to the game for a month. The investigators will measure the effect of gameplay on successful completion of detoxification/inpatient treatment and rates of linkage to next level of outpatient treatment. The investigators will also measure the effect of gameplay compared to treatment as usual (TAU) during a subsequent episode of outpatient treatment (following inpatient), on rates of treatment attendance, treatment retention, urine drug test results, substance use self-report, treatment alliance, drug craving, and treatment satisfaction.","other_id":"MREZ-001","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":15,"maximum_age":25,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  attending the MMTC inpatient program for primarily opioid or marijuana use disorder\r\n             treatment\r\n\r\n          -  ability to speak English\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  presence of a comorbid psychiatric condition that would make participation unsafe (eg,\r\n             acute suicidality or unstable psychosis)\r\n\r\n          -  pregnancy (because of the physical exertion required to play the game)\r\n      ","sponsor":"George Washington University","sponsor_type":"Other","conditions":"Relapse|Opioid Use|Marijuana Usage","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: RecoveryWarrior 2.0","description":"RecoveryWarrior 2.0 was developed for use with Microsoft Kinect running on a Windows personal computer. All games made use of whole-body motion detection and the same voice-recognition feature. Body motions included a variety of arm, leg, and whole-body movements to physically enact the motions of destroying or evading images of drugs and drug paraphernalia. Voice features consisted of recognition of the refusal phrase \"I'm Clean\" Players could say or shout \"I'm Clean\" in order to gain additional strength for their game play avatar. All game art was created in a hyperrealistic, idealized, heroic style."}],"outcomes":[{"outcome_type":"primary","measure":"Change in craving","time_frame":"baseline, discharge (up to 2 weeks from baseline), 4 week, 8 week","description":"For cravings, the 5-item Penn Alcohol Craving Scale was included at baseline, discharge, and postdischarge follow-up surveys, but modified to apply to marijuana and opioid use. It assessed the intensity of a participant's cravings (0=none at all to 6=very strong; sum of a maximum total of 30 points)."},{"outcome_type":"primary","measure":"Change in self-efficacy","time_frame":"baseline, discharge (up to 2 weeks from baseline), 4 week, 8 week","description":"Self-efficacy for refusal of drugs was measured using the Marijuana Resistance Self-Efficacy scale at baseline, discharge, and follow-up surveys. It used a 4-item, 4-point scale (1=very easy to 4=very hard) that asked participants how easy or hard it would be to refuse the drug if offered and explain why they did not want it, why they wanted to avoid the situation in the first place, and why they wanted to leave the situation. It was adapted so that there was a similar version for opioid use. Participants were only asked about the primary drug for which they enrolled in treatment (ie, marijuana or opioids)."},{"outcome_type":"secondary","measure":"Refusal Skill","time_frame":"4 week","description":"Refusal skills were measured by asking participants if they agreed that they would use the phrase \"I'm Clean\" to refuse drugs (1=not agree to 5=highly agree), if they had used the phrase \"I'm Clean\" since discharge to refuse drugs, and if the phrase \"I'm Clean\" still rings in their head (not at all, less than once per week, a few times a week, or more often)."},{"outcome_type":"secondary","measure":"Abstinence of drug use","time_frame":"Baseline, 4 week, 8 week","description":"Participants were asked about the primary drug that they were in treatment for. Opioid and marijuana use at follow-up was ascertained by self-report of any use in the past 7 and 30 days."},{"outcome_type":"other","measure":"Counselor Alliance","time_frame":"discharge (up to 2 weeks from baseline), 4 week, 8 week","description":"Treatment rating was measured in three ways. First, it was measured with the Counselor Alliance Scale, which was taken from the Working Alliance Inventory, and used to measure treatment progress with the counselor at discharge, 4 weeks, and 8 weeks. The Counselor Alliance Scale uses 7-items and 7-points to measure how well participants believe counselors are working with them to improve their situation (1=never to 7=always)."},{"outcome_type":"other","measure":"Treatment Rating","time_frame":"4 week, 8 week","description":"The treatment rating was also measured by asking participants about their satisfaction with inpatient care at the time of discharge and satisfaction with outpatient care at the 4-week and 8-week follow-up surveys."}]}
{"nct_id":"NCT03109704","start_date":"2016-02-01","phase":"N/A","enrollment":60,"brief_title":"Thoracic Spine Thrust Manipulation Compared to Sham Manipulation in Individuals With Subacromial Pain Syndrome","official_title":"The Immediate Effects of a Seated Versus Supine Upper Thoracic Spine Thrust Manipulation Compared to Sham Manipulation in Individuals With Subacromial Pain Syndrome: A Randomized Controlled Trial","primary_completion_date":"2016-10-24","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-10-26","last_update":"2019-04-03","description":"This study evaluates the immediate and short-term effects of a supine upper thoracic spine thrust manipulation, seated upper thoracic spine thrust manipulation, and sham manipulation for individuals with subacromial pain syndrome. The participants were randomized to receive one of the three interventions and baseline measures for the dependent variables were repeated immediately after the delivery of the intervention.","other_id":"151119A","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","intervention_model_description":"randomized controlled trial, 3 groups which includes a sham comparator","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  currently experiencing shoulder pain for less than 6 months\r\n\r\n          -  at least 3 of the following findings: 1) pain localized to the proximal anterolateral\r\n             shoulder region, 2) positive Neer or Hawkins-Kennedy impingement test, 3) pain with\r\n             active shoulder elevation (which may include a painful arc), 4) active shoulder\r\n             abduction ROM of at least 90, 5) passive shoulder external rotation ROM of at least\r\n             45, and 6) pain with isometric resisted abduction or external rotation\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  signs of a complete rotator cuff tear\r\n\r\n          -  significant loss of glenohumeral motion\r\n\r\n          -  acute inflammation\r\n\r\n          -  cervical spine-related symptoms including a primary complaint of neck pain, signs of\r\n             central nervous system or cervical nerve root involvement, or reproduction of shoulder\r\n             or arm pain with cervical rotation, axial compression, or Spurling test\r\n\r\n          -  previous neck or shoulder surgery\r\n\r\n          -  positive apprehension test or relocation test\r\n\r\n          -  history of shoulder fracture or dislocation\r\n\r\n          -  history of nerve injury affecting upper extremity function\r\n\r\n          -  any contraindication for thrust manipulation to the thoracic spine including\r\n             osteoporosis, fracture, malignancy, systemic arthritis, or infection\r\n\r\n          -  fear or unwillingness to undergo thoracic spine manipulation\r\n      ","sponsor":"Sacred Heart University","sponsor_type":"Other","conditions":"Subacromial Impingement|Subacromial Impingement Syndrome","interventions":[{"intervention_type":"Procedure","name":"Procedure: Supine upper thoracic spine thrust manipulation","description":"The supine thrust manipulation will target the upper thoracic spine and will be performed as previously described. The patient will be asked to lace his or her fingers behind the neck and bring his or her elbows close together in front of the chest. The therapist will place one hand just below the targeted upper thoracic region (at either the T3 or T4 level) using a pistol grip or loose fist to make contact with both transverse processes of the T3 or T4 vertebrae. The therapist will then use his or her body to push down through the patient's upper arms to provide a high-velocity, low-amplitude thrust in the anterior-to-posterior direction."},{"intervention_type":"Procedure","name":"Procedure: Seated upper thoracic spine thrust manipulation","description":"The seated thrust manipulation will target the cervicothoracic junction with the patient sitting with fingers laced behind the neck. The therapist will stand behind the patient and thread his or her arms through the patient's arms and clasp his or her hands near the C7-T1 level. The therapist will make contact with his or her chest against the patient's upper thoracic region to serve as a fulcrum. The patient will then be instructed to take a deep breath, and upon exhalation the therapist will apply a high-velocity, low-amplitude distraction thrust in a cephalad direction."},{"intervention_type":"Procedure","name":"Procedure: Sham manipulation","description":"The sham manipulation will be performed with the patient and the examiner positioned in the same manner as for the seated manipulation, however the examiner will apply only minimal pressure to maintain physical contact and \"skin lock\" with the patient. The examiner will then move the patient through the same range of motion but deliver no manipulative thrust."}],"outcomes":[{"outcome_type":"primary","measure":"Change in Penn Shoulder Score (PSS) from baseline to 48 hours","time_frame":"baseline and 48 hours after intervention","description":"The Penn Shoulder Score is a 100-point shoulder-specific questionnaire with three subscales: self-reported pain, function, and satisfaction with current use of the shoulder. The scores from the subscales are summed to determine the total score with the pain subscale score ranging from 0-30, function subscale score ranging from 0-60, and satisfaction subscale score ranging from 0-10. The total maximum score of 100 points indicates high function, low pain, and high satisfaction with the shoulder."},{"outcome_type":"primary","measure":"Change in pain","time_frame":"baseline and 1 minute after intervention","description":"Pain will be measured using the verbal numeric rating scale (VNRS). Participants will be asked to rate their pain on a 0-10 scale with 0 indicating no pain and 10 indicating the worst pain imaginable. This pain rating will be obtained during active elevation of the arm in the scapular plane."},{"outcome_type":"secondary","measure":"Change in scapular upward rotation active range of motion (ROM)","time_frame":"baseline and 1 minute after intervention","description":"The participant will start with the involved arm at the side of the body. The investigator will confirm the location of the scapular plane by placing the subject's arm at an angle 40 degrees anterior from the frontal plane as measured with a standard goniometer. The digital inclinometer will be zeroed on a horizontal surface and then placed along the scapular spine of the involved arm. The initial reading from the inclinometer on the scapular spine with the arm at the side of the body will be recorded. The subject will then be instructed to elevate the arm in the scapular plane as high as he/she can go. The final reading from the inclinometer will then be recorded at the end of the subject's maximal arm elevation. The total amount of scapular upward rotation will be calculated as the change score by taking the difference between the final and initial readings. Downward rotation would be recorded as negative values and upward rotation would be recorded as positive values."},{"outcome_type":"secondary","measure":"Change in scapular posterior tilt active ROM","time_frame":"baseline and 1 minute after intervention","description":"The participant will start with the test arm at the side of the body. The digital inclinometer will be zeroed on a vertical surface and then placed vertically along the posterior surface of the medial border of the scapula, using the root of the scapular spine and the inferior angle of the scapula as landmarks as previously described. The initial reading from the inclinometer with the arm at the side of the body will be recorded. The subject will then be instructed to elevate the arm in the scapular plane as high as he/she can go. The final reading from the inclinometer will then be recorded at the end of the subject's maximal arm elevation. The total amount of scapular posterior tilt will be calculated as the change score by taking the difference between the final and initial readings. Anterior tilt would be recorded as negative values and posterior tilt would be recorded as positive values."},{"outcome_type":"secondary","measure":"Change in scapular upward rotation passive ROM","time_frame":"baseline and 1 minute after intervention","description":"Measurements will be made with the subject in standing. The participant will start with the involved arm at the side of the body. The digital inclinometer will be zeroed and positioned as described for the measure of upward rotation active ROM. The initial reading from the inclinometer will be recorded. The examiner can then passively elevate the humerus in the scapular plane to end-range elevation, producing passive upward rotation of the scapula. The examiner will move the subject's arm through the full available elevation ROM passively for two consecutive trials. At the point of maximal passive arm elevation on the second repetition, the inclinometer will again be placed along the scapular spine to obtain a measurement of upward rotation passive ROM. The total amount of scapular upward rotation passive ROM will be calculated as the change score by taking the difference between the final and initial readings."},{"outcome_type":"secondary","measure":"Change in scapular posterior tilt passive ROM","time_frame":"baseline and 1 minute after intervention","description":"Measurements will be made with the subject standing. The digital inclinometer will be zeroed and positioned as described for the measure of posterior tilt active ROM. The initial reading from the inclinometer will be recorded with the subject's arm at the side of the body. The examiner can then passively elevate the humerus in the scapular plane to end-range elevation, producing passive posterior tilt of the scapula. The examiner will move the subject's arm through the full, available elevation ROM passively for two consecutive trials. At the point of maximal passive arm elevation on the second repetition, the inclinometer will again be placed along the posterior surface of the medial border of the scapula to obtain a measurement of posterior tilt passive ROM. The total amount of scapular posterior tilt passive ROM will be calculated as the change score by taking the difference between the final and initial readings."},{"outcome_type":"secondary","measure":"Change in pectoralis minor muscle length","time_frame":"baseline and 1 minute after intervention","description":"Performed as described previously by Borstad. A tape measure will be used to measure the linear distance in cm between the anterior-inferior edge of the 4th rib one finger width lateral to the sternum and the medial-inferior aspect of the coracoid process of the scapula. This measurement will be completed while the subject is standing in their usual resting position."},{"outcome_type":"secondary","measure":"Change in middle trapezius force production","time_frame":"baseline and 1 minute after intervention","description":"A handheld dynamometer (HHD) (Hoggan MicroFET2) will be used to assess force production in standard manual muscle test (MMT) position using a \"make test\" as previously described. The \"make test\" will require the examiner to instruct the subject to slowly push into the HHD and increase their force production to a maximal level over a 5-second period of time. Prior to maximal isometric testing, a sub-maximal (50%) effort trial will be performed to minimize learning effects. Two maximal effort trials will be performed with a 30-second rest between trials and the average of the trials (recorded in kg) will be used for data analysis. Additionally, subject body weight in kg will be recorded to allow for normalization of strength measures by dividing by subject body weight."},{"outcome_type":"secondary","measure":"Change in lower trapezius force production","time_frame":"baseline and 1 minute after intervention","description":"A handheld dynamometer (HHD) (Hoggan MicroFET2) will be used to assess force production in standard MMT position using a \"make test\" as previously described. The \"make test\" will require the examiner to instruct the subject to slowly push into the HHD and increase their force production to a maximal level over a 5-second period of time. Prior to maximal isometric testing, a sub-maximal (50%) effort trial will be performed to minimize learning effects. Two maximal effort trials will be performed with a 30-second rest between trials and the average of the trials (recorded in kg) will be used for data analysis. Additionally, subject body weight in kg will be recorded to allow for normalization of strength measures by dividing by subject body weight."},{"outcome_type":"secondary","measure":"Change in serratus anterior force production","time_frame":"baseline and 1 minute after intervention","description":"A handheld dynamometer (HHD) (Hoggan MicroFET2) will be used to assess force production in standard MMT position using a \"make test\" as previously described. The \"make test\" will require the examiner to instruct the subject to slowly push into the HHD and increase their force production to a maximal level over a 5-second period of time. Prior to maximal isometric testing, a sub-maximal (50%) effort trial will be performed to minimize learning effects. Two maximal effort trials will be performed with a 30-second rest between trials and the average of the trials (recorded in kg) will be used for data analysis. Additionally, subject body weight in kg will be recorded to allow for normalization of strength measures by dividing by subject body weight."}]}
{"nct_id":"NCT02764528","start_date":"2016-02-01","phase":"N/A","enrollment":0,"brief_title":"Intervention Study to Improve Maternal Handwashing","official_title":"Effects of Promoting Handwashing With Soap to Improve Maternal Handwashing Behavior During the Neonatal Period","primary_completion_date":"2016-12-01","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2018-08-31","last_update":"2020-11-02","description":"The purpose of the handwashing intervention trial is to determine whether an interactive, storytelling approach to promoting handwashing with soap by health care workers can improve mothers' handwashing behavior during the first month of her child's life.","other_id":"748140-1","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"Female","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Pregnant women\r\n\r\n          -  Seeking routine (non-emergency) care at a participating antenatal care clinic during\r\n             the study period\r\n\r\n          -  Between 30 and 36 weeks pregnant (calculated based on last known menstrual period)\r\n             when they seek antenatal care\r\n\r\n          -  Live within 30 minutes or 1-2 km one-way travel from the clinic\r\n\r\n          -  Plan to remain in the study area for at least one month post-partum\r\n\r\n          -  Willing to allow the field worker to visit her home following the antenatal care visit\r\n             on the day of enrollment to conduct baseline assessments at the household\r\n\r\n          -  Sought antenatal care from a qualified medical provider for the first time at or after\r\n             28 weeks gestation\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Excluded if another member of their household or compound/homestead enrolled in this\r\n             study\r\n\r\n          -  Excluded if enrolled in the formative research for this study\r\n      ","sponsor":"State University of New York at Buffalo","sponsor_type":"Other","conditions":"Infection|Neonatal","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Clinic","description":"Pregnant women will receive handwashing promotion from a trained facility-based health care worker during her regular antenatal visit at a healthcare clinic. To the extent feasible, everyone accompanying the pregnant woman will be invited to take part in the behavior change communication session. The participant will be provided with several bars of soap to take home and she will be encouraged to maintain a designated place for washing hands (with soap and water) at the home. A poster indicating the key events for handwashing with soap will be posted at the clinic and smaller posters will be given to the participant to post in her home. A system will be established to send regular SMS messages to the participant promote handwashing with soap during the neonatal period."},{"intervention_type":"Behavioral","name":"Behavioral: Clinic + home","description":"Women will receive all components of the clinic-based handwashing promotion in addition to handwashing promotion during 3-4 home visits before their expected delivery date and during the neonatal period from a community health volunteer. All household members present will be invited to join in the session, with emphasis on including all caregivers of the neonate."},{"intervention_type":"Behavioral","name":"Behavioral: Clinic + home + handwashing device","description":"Women will receive all components of the clinic + home-based handwashing promotion intervention in addition to one handwashing device (i.e. tap and basin to use as a handwashing station) during the first home visit by the community health volunteer. The community health volunteer will work with the woman and her family to identify the location where the neonate will be most of the time in order to position the handwashing station as close to the neonate as possible."}],"outcomes":[{"outcome_type":"secondary","measure":"Number of participants with soap and water present at a handwashing station","time_frame":"1 week post-natal","description":"Observed presence of soap and/or water at a handwashing station"},{"outcome_type":"secondary","measure":"Cost-effectiveness","time_frame":"1 month post-partum","description":"Approximate cost of the intervention per participant"},{"outcome_type":"primary","measure":"Frequency of washing hands with soap at potential pathogen transmission events by mothers of neonate","time_frame":"1 week post-natal","description":"Direct observation of handwashing behavior of mothers at times when pathogens may be transmitted from the mother to the neonate"},{"outcome_type":"primary","measure":"Frequency of washing hands with soap at potential pathogen transmission events by mothers of neonate","time_frame":"2 weeks post-natal","description":"Direct observation of handwashing behavior of mothers at times when pathogens may be transmitted from the mother to the neonate"},{"outcome_type":"secondary","measure":"Frequency of washing hands with soap at potential pathogen transmission events by caregivers of neonate (other than mother)","time_frame":"1 week post-natal","description":"Direct observation of handwashing behavior of caregivers (other than mother) at times when pathogens may be transmitted from the caregiver to the neonate"},{"outcome_type":"secondary","measure":"Frequency of washing hands with soap at potential pathogen transmission events by caregivers of neonate (other than mother)","time_frame":"2 weeks post-natal","description":"Direct observation of handwashing behavior of caregivers (other than mother) at times when pathogens may be transmitted from the caregiver to the neonate"},{"outcome_type":"secondary","measure":"Number of participants with soap and water present at a handwashing station","time_frame":"2 weeks post-natal","description":"Observed presence of soap and/or water at a handwashing station"}]}
{"nct_id":"NCT03268642","start_date":"2016-02-01","enrollment":150,"brief_title":"Clinical Assessment of New Treatment Regimen for Adult Fulminant Myocarditis","official_title":"Assesment of Clinical Therapeutic Efficacy of \"Life-support Based Comprehensive Treatment Regimen\" for Adult Fulminant Myocarditis","primary_completion_date":"2020-12-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2021-12-31","last_update":"2020-03-12","description":"This is a retrospective cohort study to assess the clinical outcome of patients with fulminant myocarditis using \"Life-support Based Comprehensive Treatment Regimen\" and conventional therapy. In the present study, participants receive various treatment as part of routine medical care without any assignment of specific interventions to them. The process of treatment during hospitalization were recorded in medical chart and was reviewed by independent research personnel.","other_id":"TJH-C20160202","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":16,"population":"150 hospitalized patients with fulminant myocarditis will be enrolled in this study.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  16 years of age or older;\r\n\r\n          -  Diagnosed as fulminant myocarditis:\r\n\r\n               -  Evidence of myocarditis on biopsy or increased biomarkers of myocardial injury\r\n                  (TNI and CK-MB and BNP or NT-pro-BNP);\r\n\r\n               -  Acute onset of symptoms of cardiac dysfunction: dyspnea, palpation, chest pain,\r\n                  and/or syncope;\r\n\r\n               -  Image for cardiac injury: marked diffused reduction in left ventricle wall\r\n                  movement, with dramatically decreased left ventricle ejection fraction (LVEF) <\r\n                  45%;\r\n\r\n               -  Cardiogenic shock, e.g., systolic blood pressure 90 mmHg or mean arterial\r\n                  pressure < 70mm Hg or a systolic blood pressure decrease > 40 mm Hg, which is\r\n                  associated with the signs of hypofusion: cyanosis, cold extremities, oliguria,\r\n                  and/or changes in mental status.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Also considering acute coronary syndrome but unable to perform coronary angiography to\r\n             distinguish acute coronary syndrome from fulminant myocarditis;\r\n\r\n          -  Myocardial injury caused by sepsis, chemotherapeutical agents, or poisons;\r\n\r\n          -  Unstable hemodynamics or shock caused by hypovolemia.\r\n      ","sponsor":"Tongji Hospital","sponsor_type":"Other","conditions":"Fulminant Myocarditis","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"death or cardiac transplantation","time_frame":"through hospital discharge, an average of 10 days","description":"The occurrence of death or cardiac transplantation was determined through direct contact with the patient or the family of the patient or review of the patient's medical record."}]}
{"nct_id":"NCT02557230","start_date":"2016-01-31","enrollment":250,"brief_title":"Malignant Genito-urinary Tumors in Children: South Egypt Cancer Institute Experience","official_title":"Malignant Genito-urinary Tumors in Children: South Egypt Cancer Institute Experience","primary_completion_date":"2022-03-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2022-04-30","last_update":"2021-07-27","description":"The aim of this study is to identify demographic & disease characteristics in pediatric oncology patients diagnosed with one of genitourinary tumors & treatment outcomes in these patients.","other_id":"Ped GU Tumors","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","maximum_age":18,"population":"Pediatric cancer patients, those diagnosed with any of genitourinary neoplasms, in the\r\n        period from 2001 January till 2015 December, and received treatment at the pediatric\r\n        oncology department, their medical records will be retrospectively reviewed for data\r\n        collection.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients whose age less than or equal to 18 years.\r\n\r\n          -  Patients diagnosed with any of neoplasms affecting the genitourinary system.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients whose age more than 18 years.\r\n      ","sponsor":"Assiut University","sponsor_type":"Other","conditions":"Genitourinary Neoplasms|Neoplasms, Genitourinary","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Overall survival (OS)","time_frame":"Participants will be retrospectively followed forward in time from the date of initiation of treatment till the primary completion date of the study, an expected average of 5 years","description":"Time from the date of initiation of treatment until death from any cause"},{"outcome_type":"primary","measure":"Event Free Survival (EFS)","time_frame":"Participants will be retrospectively followed forward in time from the date of initiation of treatment till the primary completion date of the study, an expected average of 5 years","description":"Time from the date of initiation of treatment until disease progression, or death for any reason."}]}
{"nct_id":"NCT02659202","start_date":"2016-01-31","phase":"N/A","enrollment":40,"brief_title":"Spinal Stimulation During Exercise in Heart Failure","official_title":"Spinal Cord Stimulation to Inhibit Afferent Feedback During Exercise in Heart Failure","primary_completion_date":"2022-12-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-12-01","last_update":"2021-02-09","description":"The purpose of this proposal is to determine whether epidural spinal cord stimulation can modulate cardiovascular control during exercise in Heart Failure patients.","other_id":"14-002521","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":90,"population":"","criteria":"\n        Inclusion Criteria, includes:\r\n\r\n          -  Heart Failure patients with reduced ejection fraction:\r\n\r\n          -  History of ischemic or idiopathic dilated cardiomyopathy (duration > 1yr.) stable for\r\n             > 3mo and New York Heart Association Class I-III\r\n\r\n          -  Not pacemaker dependent\r\n\r\n          -  Body Mass Index 35\r\n\r\n          -  Ejection Fraction < 40%\r\n\r\n          -  Current nonsmokers with < 15 pack year history\r\n\r\n          -  Able to exercise\r\n\r\n        Exclusion Criteria includes:\r\n\r\n          -  History of cardiopulmonary disorders and dangerous arrhythmias\r\n\r\n          -  Pregnant women\r\n\r\n          -  Taking prescribed opioid medications or have had a fusion or laminectomy at L3 or\r\n             above\r\n\r\n          -  Patients with a recent drug-eluding stent\r\n\r\n          -  History of spinal stenosis, lumbar radiculopathy, or peripheral neuropathy\r\n\r\n          -  Must not currently be taking blood thinners or anticoagulant medications.\r\n      ","sponsor":"Mayo Clinic","sponsor_type":"Other","conditions":"Heart Failure","interventions":[{"intervention_type":"Device","name":"Device: Precision Spinal Cord Stimulator System","description":"The precision system will consist of a pulse generator that will not be implanted, temporary percutaneous leads, surgical paddle leads and lead extensions, each packaged as a separate kit."}],"outcomes":[{"outcome_type":"primary","measure":"Mean Arterial Pressure","time_frame":"2 days","description":"This will allow for continuous real-time intra-arterial measurement of beat-to-beat blood pressure."}]}
{"nct_id":"NCT02551692","start_date":"2016-01-31","phase":"N/A","enrollment":125,"brief_title":"Effects of Smoking Environments on Craving and Smoking (CameraCue2.0)","official_title":"Effects of Smoking Environments on Craving and Smoking","primary_completion_date":"2019-01-07","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-01-07","last_update":"2020-01-18","description":"The goal of this study is to evaluate the effects of varenicline versus nicotine replacement versus placebo on personal smoking environment cue (PSE) reactivity. The results of this study will inform whether first-line pharmacotherapies for nicotine dependence (e.g. nicotine patch, varenicline) alter reactivity to environment cues. The investigators propose to identify 120 regular cigarette smokers who will complete 10 visits (1 screening visit, 1 training visit, 1 camera turn-in 2 cue exposure sessions and 4 post-quit medication check sessions). Smokers will be randomized to one of three medication conditions: placebo (PLAC; n=40), transdermal nicotine patch (NRT; n=40) or varenicline (VAR; n=40) in a double blind, double-dummy design. Reactivity variables (craving, latency to smoke, and smoke intake) will be entered into 3 (Medication: NRT, VAR, PLAC) x 2 (Environment: smoking, nonsmoking) repeated measures ANOVAs with random-effects. The investigators hypothesize that personal smoking, as compared to nonsmoking environments, will be associated with greater reactivity (i.e. increased craving and smoke intake; decreased latency to smoke). A Medication x Environment interaction will be characterized by decreased reactivity to smoking as compared to nonsmoking environments in the VAR and NRT groups as compared to the PLAC group.","other_id":"Pro00063505","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion criteria:\r\n\r\n          1. generally healthy [(i.e. ambulatory, not currently sick)]\r\n\r\n          2. between the ages of 18 and 60\r\n\r\n          3. smoking of at least 5 cig/day of a brand delivering  0.5 mg nicotine (FTC method) for\r\n             > 1 year\r\n\r\n          4. an expired CO concentration of at least 10 ppm (to confirm inhalation) or urinary\r\n             cotinine >1000 ng/mL (NicAlert = 6).\r\n\r\n          5. interest in quitting smoking within the timeframe of the experiment.\r\n\r\n          6. ability to identify 4 personal smoking and 4 personal non-smoking places.\r\n\r\n        Exclusion criteria:\r\n\r\n          1. immediate or no desire to quit smoking;\r\n\r\n          2. inability to attend all required experimental sessions;\r\n\r\n          3. use of psychoactive medications;\r\n\r\n          4. use of smokeless tobacco including e-cigarettes in the past 30 days;\r\n\r\n          5. current alcohol or drug abuse;\r\n\r\n          6. use of illegal drugs as measured by urine drug screen (excluding marijuana);\r\n\r\n          7. use of experimental (investigational) drugs;\r\n\r\n          8. current use of nicotine replacement therapy or other smoking cessation treatment;\r\n\r\n          9. Hypertension (systolic >140 mm Hg, diastolic >100 mm Hg, coupled with a history of\r\n             hypertension); subjects with no previous diagnosis of hypertension may have a\r\n             screening blood pressure up to 160/100. Participants with a history of hypertension\r\n             may, however, be allowed to participate in the study if the study physician determines\r\n             that the condition is stable, controlled by medication, and in no way jeopardizes the\r\n             individual's safety;\r\n\r\n         10. Hypotension with symptoms (systolic <90 mm Hg, diastolic <60 mm Hg);\r\n\r\n         11. Coronary heart disease;\r\n\r\n         12. Lifetime history of heart attack;\r\n\r\n         13. Cardiac (heart) disorder (including but not limited to valvular heart disease, heart\r\n             murmur, heart failure, arrhythmia); Abnormal EKG results suggestive of ischemia or\r\n             undiagnosed cardiovascular disease please consider adding if it seems reasonable. For\r\n             example, ST-segment depression or elevation, T-wave abnormalities, and lack of R wave\r\n             are obtained with a 12-lead EKG).\r\n\r\n         14. Active skin disorder (e.g., psoriasis) within the last year, except minor skin\r\n             conditions (including but not limited to facial acne, minor localized infections, and\r\n             superficial minor wounds);\r\n\r\n         15. Medical condition that may contraindicate participation in the opinion of the\r\n             investigator and study physician.(for example, EKG results)\r\n\r\n         16. Current psychiatric disease (with the exception of anxiety disorders, OCD and ADHD);\r\n\r\n         17. Suicidal ideation (within the past 10 years) or lifetime occurrence of attempted\r\n             suicide;\r\n\r\n         18. Current depression - The Prime-MD will be used to screen for current (within 2 weeks)\r\n             depression. Potential subjects who score >9 (or who score >0 on item #9 (\"Thoughts\r\n             that you would be better off dead, or of hurting yourself in some way\") will be\r\n             excluded from study participation, and, at the discretion of the study physician,\r\n             referred to appropriate psychiatric treatment;\r\n\r\n         19. Bulimia or anorexia;\r\n\r\n         20. Significant adverse reaction to Chantix/Varenicline in the past;\r\n\r\n         21. Currently pregnant, breast feeding or likely to become pregnant;\r\n\r\n         22. History of seizure disorder.\r\n\r\n         23. A quit attempt within the last 30 days\r\n      ","sponsor":"Duke University","sponsor_type":"Other","conditions":"Cigarette Smoking","interventions":[{"intervention_type":"Drug","name":"Drug: Nicotine Patch","description":"Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt continue to wear the 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions."},{"intervention_type":"Drug","name":"Drug: Varenicline","description":"Varenicline (VAR) will be administered by titrating to steady state levels over a 7 day induction period (.5 mg once daily in Days 1-3; .5 mg twice daily on Days 4-7 and 1 mg twice daily on Days 8-14). Participants will continue on 1mg twice daily until the end of treatment (days 15-84). Participants will also wear a placebo patch. During days 8-14, participants will undergo 2 cue-exposure sessions."},{"intervention_type":"Drug","name":"Drug: Placebo Nicotine Patch","description":"In the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions.\r\nIn the VAR group, participants will wear a placebo patch while taking varenicline."},{"intervention_type":"Drug","name":"Drug: Placebo Capsule","description":"In the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions.\r\nIn the NRT group, participants will take a placebo capsule while wearing nicotine patches."}],"outcomes":[{"outcome_type":"primary","measure":"Change in Craving Score During Cue Exposure Task","time_frame":"Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3)","description":"Scores range from 0 (no craving) to 100 (extreme craving)."},{"outcome_type":"primary","measure":"Change in Latency to Smoke During Cue Exposure Task","time_frame":"Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3)","description":"The latency is the interval between smoking one cigarette and wanting, craving, or needing another."},{"outcome_type":"primary","measure":"Change in Smoke Intake During Cue Exposure Task","time_frame":"Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3)","description":"Measured by number of puffs."}]}
{"nct_id":"NCT02657460","start_date":"2016-01-31","phase":"Phase 2","enrollment":90,"brief_title":"Clinical Trial of Tumor Cell-derived Microparticles Packaging Chemotherapeutic Drugs to Treat Malignant Pleural Effusion","official_title":"Clinical Trial of Tumor Cell-derived Microparticles Packaging Chemotherapeutic Drugs to Treat Malignant Pleural Effusion","primary_completion_date":"2019-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-12-31","last_update":"2019-02-26","description":"The study is to investigate the anticancer effect and the related immunological mechanism of MTX-ATMPs in the treatment of malignant pleural effusion.","other_id":"v1.4","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. The diagnosis of lung cancer and malignant pleural effusion was confirmed by pathology\r\n             and / or pleural fluid cytology;\r\n\r\n          2. The routine surgery or systemic radio/chemotherapy was ineffective, the MPE relapsed,\r\n             or routine treatment therapy was given up by self-causes;\r\n\r\n          3. stable vital sign with KPS(Karnofsky Performance Status) index more than 60;\r\n\r\n          4. 18-70 years old;\r\n\r\n          5. normal haematopoietic function of bone marrow, no hemorrhagic tendency, blood routine\r\n             test: HGB>=100g/L, WBC>4.0*10^9/L, PLT>80*10^9/L, serum ALT, AST within 2 times upper\r\n             limit of normal, BUN within 1.5 time upper limit of normal, creatinine within normal\r\n             range, normal EKG;\r\n\r\n          6. agreed to participate in the study and sign an informed consent;\r\n\r\n          7. without other severe comorbidities.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. lactating or pregnant patients;\r\n\r\n          2. allergy to multiple drugs;\r\n\r\n          3. with other severe comorbidities or psychological diseases;\r\n\r\n          4. severe infection;\r\n\r\n          5. participation in other clinical trials within the recent three months.\r\n      ","sponsor":"Wuhan Union Hospital, China","sponsor_type":"Other","conditions":"Malignant Pleural Effusion","interventions":[{"intervention_type":"Biological","name":"Biological: tumor derived microparticles","description":"The main difference between the two treatment groups is the biological coat, which is tumor derived microparticles."},{"intervention_type":"Drug","name":"Drug: cisplatin","description":"cisplatin is a traditional drug for lung cancer"}],"outcomes":[{"outcome_type":"secondary","measure":"the cytology test of pleural effusions","time_frame":"four weeks"},{"outcome_type":"secondary","measure":"Karnofsky index","time_frame":"four weeks"},{"outcome_type":"secondary","measure":"survival time","time_frame":"six month"},{"outcome_type":"secondary","measure":"carcino embryonie antigen level in microgramme/L in serum","time_frame":"four weeks"},{"outcome_type":"secondary","measure":"CYFRA21-1 level in ng/mL in serum","time_frame":"four weeks"},{"outcome_type":"secondary","measure":"neuron specific annuals level in microgramme/L in serum","time_frame":"four weeks"},{"outcome_type":"secondary","measure":"squamous cell carcinoma antigen level in ng/mL in serum","time_frame":"four weeks"},{"outcome_type":"secondary","measure":"adenosine deaminase level of pleural effusions","time_frame":"four weeks"},{"outcome_type":"primary","measure":"Pleural effusions volume","time_frame":"four weeks"},{"outcome_type":"secondary","measure":"Rivalta Test of pleural effusions","time_frame":"four weeks"},{"outcome_type":"secondary","measure":"total protein level of pleural effusions","time_frame":"four weeks"},{"outcome_type":"secondary","measure":"total karyocytes count of pleural effusions","time_frame":"four weeks"},{"outcome_type":"secondary","measure":"lactic dehydrogenase level of pleural effusions","time_frame":"four weeks"},{"outcome_type":"secondary","measure":"carcino embryonie antigen level in microgramme/L in pleural effusions","time_frame":"four weeks"}]}
{"nct_id":"NCT02521675","start_date":"2016-01-31","phase":"N/A","enrollment":50,"brief_title":"Validation of Algorithms for Basal Insulin Rate Reductions in Type 1 Diabetic Patients Practising Physical Activity in Real Life Conditions","official_title":"Multicentre Randomized Cross-over Study Assessing in Type 1 Diabetic Patients With Pump Insulin the Non-inferiority of Glycemic Control Obtained With the Algorithms Tested in DIABRASPORT Versus the Rest Period Without Physical Activity","primary_completion_date":"2020-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-03-31","last_update":"2021-04-08","description":"There is no specific recommendations on the adjustments of the insulin treatment in the event of physical activity (PA) in T1D patients treated on insulin pump therapy. Patients often prefer additional carbohydrates intake rather than the reduction of their insulin doses because of the lack of specific algorithms. The DIABRASPORT 2 study aims to demonstrate that using algorithms DIABRASPORT, during a week of physical activity (PA), the incidence of hypoglycaemia is not different from that obtained during a week of rest without physical activity. It is a multi-center European, controlled, randomized, cross-over, study, in 100 T1D patients practicing an occasional AP. 25 centers involved in this study. After agreeing to participate in the study, patients will read the information leaflet, ask questions to the investigator physician and they will date and sign the consent form. The investigator physician will do the same. They will be then drawn randomly via the electronic CRF (eCRF) to determine the order in which they will realize the rest vs DIABRASPORT sessions. The study will take place in 5 weeks: During the weeks Baseline and Diabrasport, patients will have to make 3 physical activity of 30 to 60 minutes separated by at least 24 hours: - moderate activity 3 hours after lunch - intense activity 3 hours after lunch - activity moderate 90 min after lunch They will use their usual algorithms (Cho intake or adjustment of the dose of insulin) during the week Baseline and they will use the Diabrasport algorithm during the week Diabrasport. Patients will be equipped with a holter Glycemic iPro2, Medtronic, whose data are hidden. During the week of rest, patients should do no physical activity during the week. They will be equipped with the Glycemic holter. Patients will have to fill a food survey the days they practice PA. Between each period, the patient must respect a period of wash-out for one week at least, during which he will be asked to not practice physical activity. Validation of algorithms simple, easy to implement, adaptable by patients, could help to improve balance metabolic and practice of sport among the T1D.","other_id":"2015-A00709-40","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patient aged over 18 years\r\n\r\n          -  Patient with type 1 diabetes for at least 1 year\r\n\r\n          -  Patient receiving insulin pump under basal-prandial regimen for at least 3 months\r\n\r\n          -  Patient practicing functional insulin therapy, or using a fixed plane defined food\r\n\r\n          -  Patients with a stable basal rate for at least 1 week\r\n\r\n          -  Patient practicing regular physical activity and reproducible identically\r\n\r\n          -  Patient with HbA1c older than 3 months between 6.5% and 9.5% (HbA1c  6.5%  9.5%)\r\n\r\n          -  Patients with BMI  35\r\n\r\n          -  Patient who agreed to participate in the study and who signed an informed consent\r\n\r\n          -  Patient not participating in another protocol\r\n\r\n          -  Patient covered by social security\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with a history of severe hypoglycemia without accidental cause in the 6\r\n             months preceding the entry in the protocol\r\n\r\n          -  Patient not receiving its hypoglycaemia below the threshold of 0.5 g / L\r\n\r\n          -  Patient with perforating foot ulcer or a known history of heart disease or\r\n             obliterative arteriopathy of the lower limbs, or a history of cerebrovascular\r\n             accident, or ongoing proliferative retinopathy or renal failure\r\n\r\n          -  Patient with poorly controlled hypertension\r\n\r\n          -  Pregnant woman\r\n\r\n          -  Patients deprived of liberty by judicial or administrative decision, patients placed\r\n             under legal guardianship\r\n      ","sponsor":"Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabte","sponsor_type":"Other","conditions":"Diabetes Mellitus, Type I|Adjustment of Basal Insulin Flow Rate During Physical Activity|Adjustment of Prandial Insulin in Case of Physical Activity","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Usual algorithm","description":"The patient will be fitted with a CGMS (continuous glucose monitoring system) (data not shown) and it will be given the booklet to collect events + food survey\r\nThe patient goes home and he must perform 3 physical activities during the week (30-60 minutes) using its usual algorithms (glucose administration or adaptation of the BR), in the afternoon, and spacing them at least 24 hours :\r\nModerate activity 3 hours after lunch\r\nIntense activity 3 hours after lunch\r\nModerate activity 90 min after lunch These activities should not exceed 1 hour in wherever possible"},{"intervention_type":"Behavioral","name":"Behavioral: Diabrasport algorithm","description":"The patient will be fitted with a CGMS (data not shown) and it will be given the booklet to collect events + food survey\r\nThe patient goes home and he must perform 3 physical activities during the week (identical to those carried out during the week \"test algorithms usual\" and during comparable periods) using DIABRASPORT algorithms, the afternoon and in the spacing at least 24 hours:\r\nModerate activity 3 hours after lunch\r\nIntense activity 3 hours after lunch\r\nModerate activity 90min after lunch These activities shall not exceed one hour"},{"intervention_type":"Behavioral","name":"Behavioral: Rest","description":"The patient will be fitted with a CGMS (data not shown) and it will be given the booklet to collect events + food survey.\r\nThe patient goes home and he will not perform any physical activity during the week"},{"intervention_type":"Device","name":"Device: Holter Glycemic Ipro2, Medtronic"}],"outcomes":[{"outcome_type":"primary","measure":"the number of hypoglycemic events, defined by any threshold crossing 60 mg / dL (3.33mmol / L), measured in the interstitial glucose sensor continuously over a period of 24h","time_frame":"24h"},{"outcome_type":"primary","measure":"percentage of time spent over 24 hours in the euglycemic range [70; 180] mg / dL ([3.89, 10] mmol / L)","time_frame":"24h"},{"outcome_type":"primary","measure":"percentage of time spent over 24 hours in hyperglycemia (> 180 mg / dL) (> 10 mmol / L)","time_frame":"24h"},{"outcome_type":"secondary","measure":"Number of hypoglycemic events, defined by any threshold crossing 70 mg / dL (3.9 mml / L), and <54 mg / dL (3 mmol / l) measured by interstitial continuous glucose sensors","time_frame":"1 week"},{"outcome_type":"secondary","measure":"Number of hyperglycemic events, defined by any crossing of the threshold of 180 mg / dL (10 mml / L), measured by continuous interstitial glucose sensors.","time_frame":"1 week"},{"outcome_type":"secondary","measure":"Metabolic goals analysis:","time_frame":"1 week","description":"percentage of time spent in the intervals [70; 180] and [80; 140] mg / dL, [3.89; 10] and [4.44; 7.78] mmol / L\r\npercentage of time passes hypoglycemia (<60mg / dL) (<3.33 mmol / L)\r\npercentage of time spent in hypoglycemia (<54mg / dL) (<3 mmol / L)\r\npercentage of time spent in hypoglycemia (<70mg / dL) (<3.89 mmol / L)\r\npercentage of time spent <80 mg / dL; (<4.44 mmol / L)\r\npercentage of time spent in hyperglycemia (> 180 mg / dL) (> 10 mmol / L)\r\npercentage of time spent> 140 mg / dL (> 7.78 mmol / L)"},{"outcome_type":"secondary","measure":"Nadirs analysis of blood glucose during the night (value reached)","time_frame":"1 week"},{"outcome_type":"secondary","measure":"Nadirs analysis of blood glucose during the night (time to onset)","time_frame":"1 week"},{"outcome_type":"secondary","measure":"Analysis of quantities of glucose administration consumed during and at the waning of physical activity","time_frame":"1 week"},{"outcome_type":"secondary","measure":"Comparison of average values of continuous glucose measurements according to the period (DIABRASPORT, rest and Baseline) and at different times of the day and night.","time_frame":"1 week"},{"outcome_type":"secondary","measure":"Analysis by subgroups, depending on the type of physical activity and its duration, a link between a typology of physical activity or patients, and the number of hypoglycemia events during or waning of physical activity","time_frame":"1 week"},{"outcome_type":"secondary","measure":"Analysis of evaluation questionnaires intensity PA (Borg) and quality of life (EVA)","time_frame":"1 week"},{"outcome_type":"secondary","measure":"Comparison between number of hypoglycemic events predicted by the prediction function \"DIABRASPORT\" and number of hypoglycemic events actually occurred.","time_frame":"1 week"}]}
{"nct_id":"NCT03391739","start_date":"2016-01-31","phase":"Phase 2/Phase 3","enrollment":20,"brief_title":"CART-19 Cells For R/R B-ALL","official_title":"CART-19 Cells For Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia","primary_completion_date":"2019-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-12-31","last_update":"2018-01-05","description":"There are limited treatment options for relapse/refractory B-cell acute lymphoblastic leukemia(ALL). However,CART-19 cells has emerged as a powerful targeted immunotherapy for highly refractory CD19+ acute lymphoblastic leukemia (ALL). This study aims to assess the safety and toxicity of CART-19 cells to patients with relapse/refractory B-cell ALL.","other_id":"CART-19-03","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":1,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Signed written informed consent\r\n\r\n          -  Aged between 1-60 years\r\n\r\n          -  Patients with relapsed/refractory B-cell ALL\r\n\r\n          -  Cardiac: Left ventricular ejection fraction  50%\r\n\r\n          -  Adequate renal and hepatic function\r\n\r\n          -  Performance status: Karnofsky  70%\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnant or lactating females.\r\n\r\n          -  Any co-morbidity precluding the administration of CART-19 cells.\r\n      ","sponsor":"Fujian Medical University","sponsor_type":"Other","conditions":"Relapsed/Refractory B-cell ALL","interventions":[{"intervention_type":"Biological","name":"Biological: CART-19 cells","description":"CART-19 cells treat"}],"outcomes":[{"outcome_type":"primary","measure":"Leukemia free survival","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Adverse events that are related to treatment","time_frame":"1 year"}]}
{"nct_id":"NCT02655484","start_date":"2016-01-31","phase":"N/A","enrollment":18,"brief_title":"Carbon Dioxide Rebreathing During Exercise Assisted by Non-invasive Ventilation","official_title":"Evaluation of Carbon Dioxide Rebreathing During Exercise Assisted by Non-invasive Ventilation","primary_completion_date":"2016-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-05-31","last_update":"2016-07-18","description":"The purpose of this study was to evaluate whether CO2 rebreathing occurs in healthy subjects or patients with COPD ventilated during exercise assisted by the single-limb circuit with a plateau exhalation valve at a given inspiratory positive airway pressure and a minimal level of expiratory positive airway pressure (EPAP) and whether there is a potential threshold for predicting CO2 rebreathing.","other_id":"2009CB522112","allocation":"N/A","intervention_model":"Single Group Assignment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  presented clinically stable (no exacerbation in the 4 weeks prior to study\r\n             participation or with no change in medications);\r\n\r\n          -  physician diagnosed COPD, forced expiratory volume in 1s (FEV1) < 50% predicted;\r\n\r\n          -  dyspnea as a main symptom that limited daily activities.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  subjects with obvious pulmonary bullae demonstrated by chest CT scan or X-ray;\r\n\r\n          -  examination or facial trauma/malformation, recent facial, upper airway or upper\r\n             gastrointestinal tract surgery, that would preclude receiving NIV therapy;\r\n\r\n          -  a history of coronary artery disease or cardiac arrhythmias or potential\r\n             electrocardiographic alterations;\r\n\r\n          -  a history of uncontrolled hypertension, or other respiratory diseases;\r\n\r\n          -  oxygen saturation(SpO2) < 88% at rest with a fraction of inspired oxygen (FiO2)  0.5;\r\n\r\n          -  patients with musculoskeletal or neurological disorders;\r\n\r\n          -  or failure to comply with the research protocol.\r\n      ","sponsor":"Guangzhou Institute of Respiratory Disease","sponsor_type":"Other","conditions":"Pulmonary Disease, Chronic Obstructive","interventions":[{"intervention_type":"Device","name":"Device: BiPAP Vision ventilator\"Ventilator\", \"Philips Respironics BiPAP Vision\" ","description":"See details from arm descriptions."}],"outcomes":[{"outcome_type":"primary","measure":"mean exhalation valve flow","time_frame":"Measurements were collected continuously throughout a symptom-limited cycle exercise test （test lasts for about 8-12 min） while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process."},{"outcome_type":"secondary","measure":"mean exhalation flow","time_frame":"Measurements were collected continuously throughout a symptom-limited cycle exercise test （test lasts for about 8-12 min） while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process."},{"outcome_type":"secondary","measure":"mean inspiratory fraction of CO2 for each tidal volume","time_frame":"Measurements were collected continuously throughout a symptom-limited cycle exercise test （test lasts for about 8-12 min） while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process."},{"outcome_type":"secondary","measure":"fraction of end-tidal carbon dioxide partial pressure","time_frame":"Measurements were collected continuously throughout a symptom-limited cycle exercise test （test lasts for about 8-12 min） while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process."},{"outcome_type":"secondary","measure":"inspiratory time","time_frame":"Measurements were collected continuously throughout a symptom-limited cycle exercise test （test lasts for about 8-12 min） while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process."},{"outcome_type":"secondary","measure":"expiratory time","time_frame":"Measurements were collected continuously throughout a symptom-limited cycle exercise test （test lasts for about 8-12 min） while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process."},{"outcome_type":"secondary","measure":"respiratory rate","time_frame":"Measurements were collected continuously throughout a symptom-limited cycle exercise test （test lasts for about 8-12 min） while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process."},{"outcome_type":"secondary","measure":"inspiratory tidal volume","time_frame":"Measurements were collected continuously throughout a symptom-limited cycle exercise test （test lasts for about 8-12 min） while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process."},{"outcome_type":"secondary","measure":"expiratory tidal volume","time_frame":"Measurements were collected continuously throughout a symptom-limited cycle exercise test （test lasts for about 8-12 min） while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process."}]}
{"nct_id":"NCT02435615","start_date":"2016-01-31","phase":"N/A","enrollment":15,"brief_title":"Diagnosing Dengue: Evaluating the Utility of Oral Fluid for Dengue Diagnosis","official_title":"Diagnosing Dengue: Evaluating the Utility of Oral Fluid for Dengue Diagnosis","primary_completion_date":"2016-12-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2016-12-31","last_update":"2017-10-26","description":"Dengue is the most common viral illness spread by mosquitos. It is important to diagnose dengue to prompt adequate therapy and initiate local mosquito control. Easy to use point of care tests are needed to improve dengue diagnosis. Oral fluid collection may be a simple, non-invasive way to diagnose dengue in the community. However, it is currently unknown if oral fluid is an accurate way to diagnose dengue and if the use of a specialized oral fluid collector could help to improve dengue diagnosis. In this study, the investigators will analyze the oral fluid of suspected dengue patients compared to serum samples for dengue diagnosis. From this information the investigators will be able to determine if oral fluid is a convenient way to diagnose dengue and if the oral fluid collector aids in improving diagnosis.","other_id":"20140009","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","sampling_method":"","gender":"All","minimum_age":2,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Febrile for at least 36 hours with clinical characteristics of dengue\r\n\r\n          -  Presents for care at the hospital during time of study\r\n\r\n          -  Over the age of 2 years old\r\n\r\n          -  Adults are able and willing to consent or a parent/guardian is willing and able to\r\n             accept consent for a child.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Adults that are not able to consent\r\n\r\n          -  Minors without parent/guardian consent\r\n\r\n          -  Pregnant women\r\n\r\n          -  Prisoners\r\n      ","sponsor":"University of Miami","sponsor_type":"Other","conditions":"Dengue","interventions":[{"intervention_type":"Device","name":"Device: SaniSal Oral Fluid Collector","description":"SaniSal is an oral fluid collector used to collect oral fluid from the mouth with an absorbant sponge."}],"outcomes":[{"outcome_type":"primary","measure":"Dengue Immunoglobulin M (IgM) and Non-Structural Protein 1 (NS1) Concentration in Oral Fluid","time_frame":"up to 2 years after the beginning of the study","description":"IgM and NS1 Concentration via ELISA from oral fluid collected via the SaniSal Oral Fluid collector versus pipette compared to serum concentration."},{"outcome_type":"secondary","measure":"Patient Acceptability of Oral Fluid Collector","time_frame":"up to 2 years after beginning of the study","description":"Patient interviews about the acceptability of using an oral fluid collector for diagnosis"}]}
{"nct_id":"NCT02642172","start_date":"2016-01-31","phase":"N/A","enrollment":60,"brief_title":"Prebiotics in Patients With Non-alcoholic Liver Disease","official_title":"A Randomized, Double - Blind Study With Two Parallel Arms for 4 Months (20 Weeks), Evaluating the Effectiveness of the Prebiotics in Patients With Non-alcoholic Liver Disease.","primary_completion_date":"2025-01-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2025-01-31","last_update":"2021-09-08","description":"The purpose of this present study is to evaluating whether prebiotics - ITF (Inulin/OFS 75/25) is effective in treating patients with non-alcoholic liver disease.","other_id":"PN-837-CTIL","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosis of NAFLD based on fatty infiltration detection by ultrasonography and\r\n             alanine aminotransferase levels of (ALT)  30 U/L male  19 U/L females.\r\n\r\n          -  Over-weight (BMI  27 kg/m2) who fulfill the criteria of the National Cholesterol\r\n             Education Program (NCEP) metabolic syndrome\r\n\r\n          -  Willing to sign informed consent to participate in the study\r\n\r\n          -  Patients without diabetes or with well-controlled diabetes (HbA1C < 7.5%) who are\r\n             treated by diet  metformin\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnancy\r\n\r\n          -  Uncontrolled diabetes\r\n\r\n          -  Diabetic treatment other than metformin, unusual diets (vegetarian, vegan), usage of\r\n             antibiotics, probiotics or prebiotics up to 6 months prior to study, alcohol abuse,\r\n             presence of gastrointestinal or mental disorders, weight-loss treatment, bariatric\r\n             surgery\r\n\r\n          -  Serious medical conditions\r\n\r\n          -  Evidence of another etiology for chronic liver disease such as: hepatitis B, hepatitis\r\n             C, HIV, autoimmune diseases and metabolic diseases, medications with known\r\n             hepatotoxicity.\r\n      ","sponsor":"Kaplan Medical Center","sponsor_type":"Other","conditions":"Non-alcoholic Fatty Liver Disease|Metabolic Syndrome","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: ITF (Inulin/OFS 75/25)","description":"Participants will consume 16 g/day ITF"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Placebo","description":"Participants will consume 16 g/day maltodextrin"}],"outcomes":[{"outcome_type":"primary","measure":"Change from baseline in the severity of NAFLD","time_frame":"12 weeks","description":"Determined by\r\nliver fat fraction measured by magnetic resonance spectroscopy (1H-MRS)\r\nBlood test for calculate Inflammation score using SteatoTest and NashTest (FibroMax™)\r\nBlood test for liver enzyme"},{"outcome_type":"secondary","measure":"Change from baseline of gut microbiota composition.","time_frame":"12 weeks","description":"Quantitative evaluation of the change in the composition of bacteria from stool samples"},{"outcome_type":"secondary","measure":"Change from baseline in glycemic control","time_frame":"12 weeks","description":"Determine by OGTT."},{"outcome_type":"secondary","measure":"Change from baseline in insulin sensitivity","time_frame":"12 weeks","description":"Which will be determined by a fasting Glucose and Insulin blood tests and Calculate homeostasis model assessment (HOMA)."},{"outcome_type":"secondary","measure":"Change from baseline in lipid profile","time_frame":"12 weeks","description":"Which will be determined by blood test for lipid profile - Triglycerides, cholesterol-LDL and cholesterol-HDL"}]}
{"nct_id":"NCT03374124","start_date":"2016-01-31","enrollment":100,"brief_title":"The Surgical Prognosis Based Diagnostic Strategy for Eosinophilic Chronic Rhinosinusitis","official_title":"The Surgical Prognosis Based Diagnostic Strategy for Eosinophilic Chronic Rhinosinusitis: A Retrospective Study","primary_completion_date":"2018-01-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2018-06-30","last_update":"2017-12-15","description":"Previous studies have demonstrated that the eosinophilic inflammation of nasal mucosa is associated with the uncontrolled condition of chronic rhinosinusitis after surgery. However, the definition of the eosinophilic chronic rhinosinusitis is not very clear. Japanese researchers have designed a scoring system to diagnose eosinophilic chronic rhinosinusitis. In this study, the investigators hope to examine the practicability of this scoring system and have a better knowledge of eosinophilic chronic rhinosinusitis in china.The retrospective study was conducted in a tertiary hospital. Participants received functional endoscopic sinus surgery more than 1 years were called back for evaluation. A diagnosis cut off value of eosinophil count was determined by the surgery prognosis. Then different factors were compared between participants with eosinophilic CRS and those with non-eosinophilic CRS to establish the appropriated diagnosis approach for eosinophilic CRS.","other_id":"20171019","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":70,"population":"Chronic rhinosinusitis patients after endoscopic surgery","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosis of chronic rhinosinusitis according to European position paper of\r\n             rhinosinusitis and nasal polyps 2007.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Immunodeficiency diseases, history of head and/or facial trauma, cancer or organ\r\n             transplant recipients.\r\n\r\n          -  Pregnancy or lactation.\r\n\r\n          -  Acute respiratory tract infection within one month before the study.\r\n\r\n          -  Patients without pathological samples.\r\n\r\n          -  Antrochoanal polyp and cyst of the paranasal sinuses.\r\n      ","sponsor":"Jianbo Shi","sponsor_type":"Other","conditions":"Sinusitis|Nasal Polyps","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: sinonasal outcome test-22","description":"Evaluate the nasal mucosal inflammation condition and overall quality-of-life of CRS patients"}],"outcomes":[{"outcome_type":"primary","measure":"nasal symptoms","time_frame":"through study completion, an average of 2 year","description":"presence of bothersome congestion or rhinorrhea or olfactory loss or headache.(VAS more than 7 points)."},{"outcome_type":"primary","measure":"endoscopic appearance indicate the uncontrol of CRS","time_frame":"through study completion, an average of 2 year","description":"The presence of diseased mucosa (nasal polyps, mucopurulent secretions,and/or inflamed mucosa) under endoscopy.\r\n(Lund-kennedy endoscopic score: Polyp≥1 or Oedema≥2 or Discharge≥2; 0-Absence of polyps;1-polyps in middle meatus only;2-polyps beyond middle meatus but not blocking the nose completely;3-polyps completely obstructing the nose.\r\nOedema: 0-absent; 1-mild; 2-severe.Discharge: 0-no discharge; 1-clear, thin discharge; 2-thick, purulent discharge.)"}]}
{"nct_id":"NCT02683330","start_date":"2016-01-31","phase":"N/A","enrollment":60,"brief_title":"Distant Delivery of a Mindfulness-based Intervention for People Affected by Parkinson's Disease","official_title":"Mindfulness-based Intervention for People Affected by Parkinson's Disease: A Distant-delivered Randomised Pilot Trial","primary_completion_date":"2016-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-03-31","last_update":"2019-02-01","description":"Psychological difficulties, especially depression and anxiety are the most prevalent non-motor symptoms in Parkinson's Disease (PD). Pharmacological treatments are not as effective in PD. Mindfulness courses have received increased popularity and recognition as an effective way to manage emotional states, and there is ever growing findings of the effectiveness of mindfulness courses for people with long-term medical conditions. Two small pilot studies have indicated that mindfulness courses can be helpful for people with PD in improving symptoms of depression, language functioning and motor symptoms. The investigators propose to deliver these courses remotely, through Skype video conferences, to make it more accessible for people with mobility limitations and people who live in rural areas.","other_id":"PSYETH (S/F) 15/16 112","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  be diagnosed with PD according to PD Brain Bank criteria by a neurologist or\r\n             geriatrician\r\n\r\n          -  have a computer and internet access at home, since the course will be delivered via\r\n             Skype\r\n\r\n          -  be able to communicate in English fluently\r\n\r\n          -  be stabilised on mood altering medication and/or Parkinson's medication for a month\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  have severe cognitive impairment that would make participation in the mindfulness\r\n             sessions and home practice of mindful meditation problematic or distressing. This will\r\n             be assessed using the Telephone Interview for Cognitive Status-Modified (TICS-M,\r\n             Brandt et al., 1993).\r\n\r\n          -  have severe psychiatric conditions (e.g. psychosis, drug/ alcohol addiction) that can\r\n             potentially risk failure in the treatment or limit participation in the course\r\n\r\n          -  have severe hearing impairment\r\n\r\n          -  are currently participating in other psychological therapies\r\n\r\n          -  have prior formal training in mindfulness methods or current meditation practice\r\n      ","sponsor":"City, University of London","sponsor_type":"Other","conditions":"Parkinson's Disease","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Mindfulness-based intervention (MBI)","description":"MBI consists of 8 sessions and will cover becoming aware of emotions, thoughts and physical sensations, decentering and acceptance. Recordings of the body scan, a sitting meditation and a mindful movement meditation will be provided for daily home practice. Special care will be taken to address safety in the context of PD, and to adapt meditations to the physical limitations of PD."}],"outcomes":[{"outcome_type":"primary","measure":"Change from baseline Hospital Anxiety and Depression Scale (HADS) at 4, 8 and 20 weeks","time_frame":"Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20).","description":"HADS also assessed at Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20) time points."},{"outcome_type":"secondary","measure":"Parkinson's Disease Activities of Daily Living Scale (PADLS)","time_frame":"Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)"},{"outcome_type":"secondary","measure":"Brief Pain Inventory (BPI)","time_frame":"Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)"},{"outcome_type":"secondary","measure":"Fatigue Severity Scale (FSS)","time_frame":"Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)"},{"outcome_type":"secondary","measure":"Insomnia Severity Index (ISI)","time_frame":"Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)"},{"outcome_type":"other","measure":"Self-Compassion Scale (SCS)","time_frame":"Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)"},{"outcome_type":"other","measure":"Philadelphia Mindfulness Scale (PHLMS)","time_frame":"Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)"},{"outcome_type":"other","measure":"Experiences Questionnaire (EQ)","time_frame":"Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)"},{"outcome_type":"other","measure":"Acceptance Action Questionnaire (AAQ-II)","time_frame":"Baseline, Mid-intervention (week 4), Post-intervention (week 8) and Follow-up (week 20)"},{"outcome_type":"other","measure":"Subjective Well-Being questionnaire (SWB)","time_frame":"Baseline, Post-intervention (week 8) and Follow-up (week 20)"},{"outcome_type":"other","measure":"EuroQol Five-Dimensional questionnaire (EQ-5D-3L)","time_frame":"Baseline, Post-intervention (week 8) and Follow-up (week 20)"},{"outcome_type":"other","measure":"Visual Analogue Scale (VAS)","time_frame":"Baseline, Post-intervention (week 8) and Follow-up (week 20)"},{"outcome_type":"other","measure":"ICEpop CAPability measure for Adults (ICECAP-A)","time_frame":"Baseline, Post-intervention (week 8) and Follow-up (week 20)"},{"outcome_type":"other","measure":"Adult Social Care Outcomes Toolkit (ASCOT)","time_frame":"Baseline, Post-intervention (week 8) and Follow-up (week 20)"}]}
{"nct_id":"NCT03887754","start_date":"2016-01-31","phase":"Phase 2","enrollment":80,"brief_title":"Therapeutic Issues for Autism","official_title":"Therapeutic Issues for Autism Spectrum Disorders: a Clinical Trial","primary_completion_date":"2018-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-12-31","last_update":"2019-03-25","description":"This study aimed to show the effects of hyperbaric oxygen therapy and/or Risperidone in improving symptoms of autism","other_id":"Autism Spectrum Disorder","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","intervention_model_description":"Children were divided into four groups.Twenty autistic children in each group. They followed up for 2 years.","sampling_method":"","gender":"All","minimum_age":5,"maximum_age":7,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  age of 5-7 years\r\n\r\n          -  weight of at least 15 kg\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Absence of significant medical problems and any other neuropsychiatric disorder\r\n             requiring drug therapy (e.g., Bipolar disorder, psychosis).\r\n\r\n          -  No concomitant treatment with psychotropic medication was allowed during the study.\r\n\r\n          -  Weight less than 15 kg.\r\n\r\n          -  Other cardiac, liver, gastrointestinal, renal, endocrine, blood and metabolic diseases\r\n      ","sponsor":"Minia University","sponsor_type":"Other","conditions":"Autism Spectrum Disorder","interventions":[{"intervention_type":"Drug","name":"Drug: Risperidone","description":"It is antipsychotic drug used by dose: 0.25 mg per day in children weighing less than (20 kg); 0.5 mg per day in persons weighing more for 8 months."},{"intervention_type":"Device","name":"Device: hyperbaric oxygen therapy","description":"Sessions were done at pressure 1.5 ATA (atmosphere absolute) with 100% oxygen concentration, each lasting for one hour either in multiplace chamber or in monoplace chamber."},{"intervention_type":"Drug","name":"Drug: Non specific Multivitamin","description":"control group received non specific multivitamins as placebo for 8 months."}],"outcomes":[{"outcome_type":"primary","measure":"Childhood Autism Rating Scale version 2 (CARS2)measured after one year and after two years to compare the effect of hyperbaric oxygen therapy, Risperidone, both of them and the placebo effect","time_frame":"two years","description":"The CARS is a 15 items behavioral rating scale developed to identify autism as well as to quantitatively describe the severity of the disorder. The items are as follows: I. Relating to People; II. Imitation; III. Emotional Response; IV. Body Use; V. Object Use; VI. Adaptation to Change; VII. Visual Response; VIII. Listening Response; IX. Taste; Smell, and Touch Response and Use; X. Fear or Nervousness; XI. Verbal Communication; XII. Nonverbal Communication; XIII. Activity Level; XIV. Level and Consistency of Intellectual Response; and XV. General Impressions. Each item is scored from 1 (no pathology) to 4 (severe pathology) in 0.5 intervals. A total score of 15-29.5 is considered non-autistic to minimal; a score of 30-36.5 is considered mild to moderate autism; a score of 37-60 is considered severe autism (these are based on raw scores)"}]}
{"nct_id":"NCT02844543","start_date":"2016-01-31","phase":"N/A","enrollment":155,"brief_title":"EYE-TRAC Advance: Technology Verification (ETA-TV) Cohort 1","official_title":"EYE-TRAC Advance: Technology Verification (ETA-TV) Cohort 1","primary_completion_date":"2016-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-12-31","last_update":"2018-05-30","description":"This study will assess the effects of exercise and non-concussive bodily contact on eye-tracking scores collected by the EYE-SYNC eye-tracking device.","other_id":"34662","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":25,"population":"","criteria":"\n        Inclusion criteria\r\n\r\n          -  Athletes between the age of 18- 25-years-old.\r\n\r\n          -  20/30 or better eyesight (corrected vision allowed).\r\n\r\n          -  English fluency.\r\n\r\n        Exclusion criteria\r\n\r\n        Note: Under Cohort 1, Athletes that have conditions listed below will not be excluded from\r\n        the study. They will be enrolled and their subject data will be analyzed separately from\r\n        subjects who do not endorse any significant medical hx under neurological, eye-sight, or\r\n        psychiatric categories.\r\n\r\n          -  Clinical diagnosis of a neurological condition including the following: Stroke,\r\n             Multiple Sclerosis, Epilepsy, Brain Tumor/Cancer, Nystagmus and/or other major\r\n             neurological condition.\r\n\r\n          -  Clinical diagnosis of any of the following eye-sight abnormalities: Uncorrected\r\n             Amblyopia, Uncorrected Myopia, Uncorrected Presbyopia, Uncorrected Farsightedness, or\r\n             Uncorrected Astigmatism.\r\n\r\n          -  Psychiatric history with any of the following:\r\n\r\n               1. Clinical diagnosis of a psychotic disorder, bipolar disorder - lifetime\r\n\r\n               2. Clinical diagnosis of ADHD or ADD - Lifetime\r\n\r\n               3. Clinical diagnosis of major depressive disorder - within last year\r\n\r\n               4. Clinical diagnosis of substance abuse disorder - within last year\r\n\r\n               5. Clinical diagnosis of major anxiety disorder - within last year\r\n\r\n                  MEDICATION\r\n\r\n               6. Requires use of a psychotropic medication.\r\n      ","sponsor":"Stanford University","sponsor_type":"Other","conditions":"Eye-tracking","interventions":[{"intervention_type":"Device","name":"Device: EYE-SYNC eye-tracking device","description":"The EYE-SYNC portable eye-tracking system. The eye tracker is a handheld isolated display environment with embedded eye tracking sensors. The eye tracker is connected to a high-performance Windows tablet though a customized docking station. Included accessories with EYE-SYNC are a U.S. tablet power supply adapter and disposable sanitary masks. Participants are asked to follow a dot with their eyes, as the dot moves on the screen of the EYE-SYNC device."},{"intervention_type":"Other","name":"Other: SCAT-3","description":"The Symptom subtest of SCAT-3 assessment tool will be administered to participants."},{"intervention_type":"Device","name":"Device: Desktop Eye-Tracker","description":"Eye movements are recorded with an eye tracking system (Desktop Eye-Tracker, Eyelink CR, SR Research) with up to 1000 Hz temporal resolution. The target stimulus is presented on a computer screen approximately 50 cm from the participant. Participants are asked to follow a dot with their eyes, as the dot moves on the monitor screen of the desk-top eye-tracking device."}],"outcomes":[{"outcome_type":"primary","measure":"Changes in the Eye-tracking Score Before and After Practice or Game: Phase Error","time_frame":"Up to 6 hours","description":"The EYE-SYNC test was performed before and after practice to analyze the effect of exercise and sub-concussive impact. The movement of eye was tracked using EYE-SYNC. The data were recorded in a surface tablet connected to EYE-SYNC.\r\nPhase error is defined as the difference in degrees between movement of the target and the movement of the eye. Positive values indicate the eye is ahead of the target; negative values indicate the eye is behind the target."},{"outcome_type":"primary","measure":"Changes in the Eye-tracking Score Before and After Practice or Game: Tangential and Radial Error","time_frame":"Up to 6 hours","description":"The EYE-SYNC test was performed before and after practice to analyze the effect of exercise and sub-concussive impact. The movement of eye was tracked using EYE-SYNC. The data were recorded in a surface tablet connected to EYE-SYNC.\r\nTangential and radial error are defined as degrees of variation in eye tracking along a circular path (tangential) and at 90 degrees to the tangential path (radial). Positive values indicate the eye is ahead of the target; negative values indicate the eye is behind the target."},{"outcome_type":"primary","measure":"Changes in the Eye-tracking Score Before and After Practice or Game: Vertical and Horizontal Gain","time_frame":"Up to 6 hours","description":"The EYE-SYNC test was performed before and after practice to analyze the effect of exercise and sub-concussive impact. The movement of eye was tracked using EYE-SYNC. The data were recorded in a surface tablet connected to EYE-SYNC.\r\nVertical and horizontal gain are defined as the ratio of velocity (velocity of the eye:velocity of the target). Positive values indicate the eye is ahead of the target; negative values indicate the eye is behind the target."},{"outcome_type":"secondary","measure":"Changes in Sport Concussion Assessment Tool (SCAT-3) Standardized Assessment of Concussion (SAC) Score","time_frame":"Day of study/event (up to 6 hours)","description":"Change in SCAT-3 SAC score before and after practice or game is reported. The SAC score is based on the following assessments: number of symptoms (22 points), symptom severity (132 points), orientation (5 points), immediate memory (15 points), concentration (5 points), and delayed recall (5 points). Scores are summed for a possible range of 0 to 184, with lower scores corresponding to fewer concussion symptoms, and higher scores corresponding to more concussion symptoms."}]}
{"nct_id":"NCT02713243","start_date":"2016-01-16","phase":"Phase 2","enrollment":20,"brief_title":"To Assess Safety, Tolerability and Efficacy of LJN452 in Patients With Primary Bile Acid Diarrhea.","official_title":"A Double Blind, Randomized Placebo Controlled Crossover Multiple Dose Study of LJN452 to Assess Safety, Tolerability and Efficacy in Patients With Primary Bile Acid Diarrhea (pBAD).","primary_completion_date":"2018-01-25","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-01-25","last_update":"2021-01-05","description":"The purpose of this study is to determine whether LJN452 improves the symptoms of bile acid diarrhea and to assess its safety and tolerability profile in patients with primary bile acid diarrhea (pBAD) to guide decision-making regarding further clinical development in this indication.","other_id":"CLJN452X2202","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Key Inclusion Criteria:\r\n\r\n          -  A history of diarrheal symptoms for at least 3 months prior to dosing - Average stool\r\n             frequency of at least 2 per day when off therapy AND Average stool form of >5 on\r\n             Bristol Stool Chart.\r\n\r\n          -  Previous laboratory or radiological confirmation of bile acid malabsorption with\r\n             either fecal bile acid loss OR 7 day 75Selenium homocholic acid taurine (75SeHCAT)\r\n             retention.\r\n\r\n          -  Age  18 years.\r\n\r\n        Key Exclusion Criteria:\r\n\r\n          -  Patients with other diagnoses leading to diarrhea, including colorectal neoplasia,\r\n             ulcerative colitis, Crohn's disease, celiac disease, chronic pancreatitis,\r\n             drug-induced diarrhea or active infection AND Patients who have not been investigated\r\n             by standard clinical assessments to exclude these disorders.\r\n\r\n          -  Treatment with bile acid sequestrants (colestyramine, colestipol, colesevelam) for 2\r\n             weeks before the first dose of LJN452. A washout of 14 days for these agents will be\r\n             allowed before first dosing.\r\n\r\n          -  Women of child-bearing potential, defined as all women physiologically capable of\r\n             becoming pregnant.\r\n\r\n          -  A positive Hepatitis B surface antigen or Hepatitis C test result.\r\n\r\n          -  History of immunodeficiency diseases, including a positive HIV (ELISA and Western\r\n             blot) test result.\r\n      ","sponsor":"Novartis Pharmaceuticals","sponsor_type":"Industry","conditions":"Primary Bile Acid Diarrhea","interventions":[{"intervention_type":"Drug","name":"Drug: LJN452","description":"Capsules containing LJN452"},{"intervention_type":"Drug","name":"Drug: Placebo to LJN452","description":"Capsules containing placebo to LJN452"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Patients Reported With Adverse Events , Serious Adverse Events and Death.","time_frame":"up to Day 79","description":"Number of patients reported with adverse events , serious adverse events and death."},{"outcome_type":"primary","measure":"Stool Frequency at Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 Combined","time_frame":"Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 combined","description":"Stool frequency at Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 combined"},{"outcome_type":"primary","measure":"Stool Form at Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 Combined","time_frame":"Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 combined","description":"Stool Form at Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 combined Clinical Symptoms will be measured as change from baseline in stool types per Bristol Stool Scale. The Bristol Stool Scale is a medical aid designed to classify feces on a scale from 1 to 7 according to increasing wateriness."},{"outcome_type":"secondary","measure":"Area Under the Plasma Concentration-time Profile (AUCtau) of LJN452","time_frame":"Day 1 (Period 1 & 2) and Day 12 (Period 1 & 2)","description":"AUCtau- is the area under the plasma (or serum or blood) concentration-time curve from time zero to the end of the dosing interval tau [mass x time / volume]"},{"outcome_type":"secondary","measure":"(Cmax) of LJN452","time_frame":"Day 1 (Period 1 & 2) and Day 12 (Period 1 & 2)","description":"Cmax is the observed maximum plasma (or serum or blood) concentration following drug administration [mass / volume]"},{"outcome_type":"secondary","measure":"Time to Reach Maximum Concentration After Drug Administration (Tmax)","time_frame":"Day 1 (Period 1 & 2) and Day 12 (Period 1 & 2)","description":"Tmax is the time to reach the maximum concentration after drug administration [time]"},{"outcome_type":"secondary","measure":"Total Dose of Rescue Medication Used at Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 Combined","time_frame":"Baseline, Week 1 (Period 1 & 2), Week 2 (Period 1 & 2), Week 1 & 2 combined","description":"Total Dose of Rescue Medication used at Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 combined; Rescue Medication used was loperamide"}]}
{"nct_id":"NCT03104218","start_date":"2016-01-11","phase":"N/A","enrollment":40,"brief_title":"Transcranial Direct Current Stimulation to Enhance Rehabilitation in Individuals With Rotator Cuff Tendinopathy","official_title":"Transcranial Direct Current Stimulation to Enhance Rehabilitation in Individuals With Rotator Cuff Tendinopathy: a Triple-blind Randomized Control Trial","primary_completion_date":"2017-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-05-31","last_update":"2017-09-18","description":"Transcranial direct current stimulation (tDCS), an electrostimulation technique known to modulate the motor cortex excitability, has been shown to enhance the effects of rehabilitation in populations with neurological injuries. tDCS could similarly be effective in individuals with rotator cuff (RC) tendinopathy, as this pathology is also associated with pain and motor control deficits. For the treatment of RC tendinopathy, sensorimotor training is effective to reduce pain, increase function and enhance motor control of the shoulder. The addition of tDCS during sensorimotor training could enhance motor learning associated with sensorimotor training and thus improve treatment outcome. PURPOSE: To compare, in terms of symptoms, functional limitations and shoulder control, a group receiving a rehabilitation program centered on sensorimotor training combined with tDCS to a group receiving the same rehabilitation program combined with sham tDCS in individuals with RC tendinopathy. METHODS: Forty adults with RC tendinopathy will take part in the 4 evaluation sessions (0, 3, 6, 12 weeks) and a 6-week rehabilitation program. Outcome measures will be symptoms and functional limitations (Disability of the Arm, Shoulder and Hand and the Western Ontario Rotator Cuff index), as well as acromiohumeral distance ([AHD] ultrasonographic measurement at 0 and 60 of elevation arm). The rehabilitation program will include sensorimotor training, strengthening and education. tDCS will be apply during sensorimotor training on the motor cortex contralateral to the side of pain. A 2-way ANOVA will be used to analyse the effects of tDCS on the outcomes.","other_id":"Jean-Sbastien Roy","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","intervention_model_description":"This triple-blind (patients, therapist & evaluator), parallel-group RCT will include four evaluation sessions over 3 months (baseline, week 3, week 6, 3-month) and 8 supervised physiotherapy treatments during a 6-week rehabilitation program (3 sessions the 1st week, 2 sessions the 2nd weeks, 3 session in the last 4 weeks). Thereafter, participants will be randomly assigned to one of two intervention groups, and then take part in their assigned 6-week intervention. At week 3, 6, and 12, the self-administered questionnaires will be re-administered, while US measurements will only be re-evaluated at week 6.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  painful arc of movement\r\n\r\n          -  positive Neer or Kennedy-Hawkins tests\r\n\r\n          -  pain on resisted isometric lateral rotation or abduction, or positive Jobe test. The\r\n             diagnosis accuracy of the combination of these tests has been studied (sensitivity &\r\n             specificity  0.74)\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. fracture at the symptomatic upper limb;\r\n\r\n          2. previous neck or shoulder surgery;\r\n\r\n          3. shoulder pain reproduced during active neck movement;\r\n\r\n          4. shoulder capsulitis;\r\n\r\n          5. clinical signs of a full thickness RC tear;\r\n\r\n          6. rheumatoid, inflammatory, or neurological diseases;\r\n\r\n          7. behavioural or cognitive problems.\r\n      ","sponsor":"Laval University","sponsor_type":"Other","conditions":"Rotator Cuff Tendinopathy","interventions":[{"intervention_type":"Other","name":"Other: tDCS group","description":"Interventions: movement training, strengthening, patient education. tDCS will be delivered using a direct current stimulator (constant current of 1.5 mA) via two 35cm2 (5 x 7 cm) saline-soaked surface sponge electrodes (parameters shown effective to enhance training).40 The center of the active electrode will be positioned over C3/C4 (international 10-20 EEG system; corresponding to the cortical representation of upper limb muscles)57, contralateral to the side of pain and the reference electrode over the contralateral supraorbital region. Current intensity will be ramped up (0-1.5 mA) and down (1.5-0 mA) over 15 seconds at the beginning and end of the 30 minutes stimulation period."},{"intervention_type":"Other","name":"Other: Placebo group","description":"Interventions: movement training, strengthening, patient education. The sham tDCS involves electrodes placed in an identical position to that used for active stimulation; however the stimulation will be turned on for 15 seconds and then off to provide participants with the initial \"itching\" sensation but without current for the remainder of the period. This procedure has been shown to effectively blind participants to the stimulation condition."}],"outcomes":[{"outcome_type":"primary","measure":"Change from Symptoms perceived at week 3,6 and 12.","time_frame":"At week 3, 6, and 12, the self-administered DASH questionnaires will be administered.","description":"Change from Baseline Symptoms perceived at week 3,6 and 12 with DASH (Disability of the Arm, Shoulder and Hand; self-administered questionnaire)"},{"outcome_type":"primary","measure":"Change from Functional limitations perceived at week 3,6 and 12.","time_frame":"At week 3, 6, and 12, the self-administered WORC questionnaire will be administered.","description":"Change from Functional limitations at week 3,6 and 12 with WORC (Western Ontario Rotator Cuff Index; self-administered questionnaire)"},{"outcome_type":"secondary","measure":"Change from US measurement of supraspinatus tendon at week 0 and 6.","time_frame":"US measurement will be performed at week 0 and 6.","description":"US measurement of supraspinatus tendon will be assessed. Supraspinatus tendon measures will be obtained with the transducer perpendicularly, one centimeter behind to the anterolateral aspect of the surface of the acromion. The thickness of the tendon borders will be defined inferiorly as the first hyperechoic region above the anechoic articular cartilage of the humeral head, and the hyperechoic superior border of the tendon before the anechoic subdeltoid bursa. Three measures will be taken, and the mean tendon thickness measured will be expressed as a percentage of the mean AHD at rest using the following formula: occupation ratio = [(tendon thickness/AHD) x 100]."},{"outcome_type":"secondary","measure":"Change from Corticospinal excitability of the infraspinatus (IS) muscle at day 1 before the first treatment and day 1 after the first treatment.","time_frame":"Through first tDCS treatment of each participant.","description":"Corticospinal excitability of the infraspinatus (IS) muscle will be acquired using a stimulator. Stimuli will be applied over grid sites spaced 1 cm apart and positioned over the upper limb area of primary motor cortex (M1). Prior to the experiment, subjects will be asked to perform two IS maximal voluntary contractions (MVC). Maximal value over the two trials will be used to compute electromyographic targets during experimental task. Corticospinal excitability will be evaluated during slight voluntary contraction.The optimal location for stimulation of IS will be determined (hotspot), as well as the active motor threshold (aMT) at this site. aMT will be determined as the minimal intensity of stimulation required to elicit motor evoked potential (MEP) larger than 150 μ Volts in at least 6 out of 12 trials at the hotspot for IS at 5% of MVC. Ten stimulations will be performed at the hotspot at 120% of the threshold for IS."},{"outcome_type":"secondary","measure":"Change from US measurement of AHD at week 0 and 6.","time_frame":"US measurement of AHD will be performed at week 0 and 6.","description":"US measurement of AHD will be performed using an ultrasound scanner with a 7.5-12 Mhz linear array probe. The US measurement of AHD is defined as the tangential distance between the hyperechoic bony landmarks of the humeral head and the inferior edge of the acromion visible on the longitudinal sonogram. Measurement obtained represents the AHD at the anterior outlet of the subacromial space. Measurements will be taken in a sitting position with the arm at rest, and at 45° and 60° of active abduction. For each arm position, two measures will be taken, and the mean AHD will be calculated. These measures are highly reliable (ICC > 0.90)."}]}
{"nct_id":"NCT03195179","start_date":"2016-01-01","enrollment":200,"brief_title":"Primary Urethral Realignment Versus Suprapubic Cystostomy After Pelvic Fracture Urethral Injury","official_title":"The Outcomes of Primary Urethral Realignment Versus Suprapubic Cystostomy After Pelvic Fracture Urethral Injury","primary_completion_date":"2026-12-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2026-12-31","last_update":"2020-08-25","description":"Pelvic fracture urethral injuries (PFUI) occur in up to 10% of pelvic fractures. It remains controversial whether initial urethral realignment after PFUI decreases rates of urethral obstruction and the need for subsequent urethral procedures. The retrospective record review should determine the utility of acute urethral realignment after PFUI.","other_id":"00094160","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"Male","minimum_age":18,"population":"Men experiencing a traumatic pelvic fracture urethral injury where there is a major\r\n        urethral disruption that prevents passage of a catheter or a retrograde cystoscope.","criteria":"\n        Inclusion Criteria:\r\n\r\n        Men > 18 years old Blunt force trauma Presence of pelvic fracture Urethral injury Inability\r\n        to pass a Foley catheter retrograde through the injury into the bladder\r\n\r\n        Exclusion Criteria:\r\n\r\n        Straddle type urethral injuries without a pelvic fracture Passage of a catheter\r\n        successfully in a retrograde fashion\r\n      ","sponsor":"University of Utah","sponsor_type":"Other","conditions":"Pelvic Fracture|Urethra Tear|Urethra Injury Male|Trauma|Surgery","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Urethral obstruction","time_frame":"Through study completion, an average of 1 year","description":"Rates of urethral obstruction identified by urethrogram or cystoscopy"},{"outcome_type":"secondary","measure":"Treatment rate for urethral obstruction","time_frame":"Through study completion, an average of 1 year","description":"The rate of interventions for urethral obstruction after injury"},{"outcome_type":"secondary","measure":"Urethroplasty complexity - gap length during urethroplasty","time_frame":"Through study completion, an average of 1 year","description":"The gap between the 2 severed ends of the urethra"},{"outcome_type":"secondary","measure":"Urethroplasty complexity - bulbar mobilization length during urethroplasty","time_frame":"Through study completion, an average of 1 year","description":"The length of bulbar mobilization"},{"outcome_type":"secondary","measure":"Urethroplasty complexity - corporal splitting during urethroplasty","time_frame":"Through study completion, an average of 1 year","description":"The need to split the 2 corporal bodies"},{"outcome_type":"secondary","measure":"Urethroplasty complexity - total obstruction of the urethra during urethroplasty","time_frame":"Through study completion, an average of 1 year","description":"Finding the urethra was completely obstructed"},{"outcome_type":"secondary","measure":"Urethroplasty complexity - urethral diverticulum discovered during urethroplasty","time_frame":"Through study completion, an average of 1 year","description":"Finding a urethral diverticulum"},{"outcome_type":"secondary","measure":"Urethroplasty complexity - urethral fistula present","time_frame":"Through study completion, an average of 1 year","description":"Finding a urethral fistula"},{"outcome_type":"secondary","measure":"Urethroplasty complexity - inferior pubectomy during urethroplasty","time_frame":"Through study completion, an average of 1 year","description":"The need to remove the inferior portion of the symphysis pubis"},{"outcome_type":"secondary","measure":"Urethroplasty complexity - total pubectomy during urethroplasty","time_frame":"Through study completion, an average of 1 year","description":"The need to remove the complete symphysis pubis"},{"outcome_type":"secondary","measure":"Erectile function- SHIM score","time_frame":"Through study completion, an average of 1 year","description":"Erectile function measured by the Sexual Health Inventory for Men (SHIM)"},{"outcome_type":"secondary","measure":"Erectile function - medical treatment rates","time_frame":"Through study completion, an average of 1 year","description":"Measured by the need for pharmacologic treatment of erectile dysfunction"},{"outcome_type":"secondary","measure":"Erectile function - surgical treatment rates","time_frame":"Through study completion, an average of 1 year","description":"Rates of surgical treatment of erectile dysfunction"},{"outcome_type":"secondary","measure":"Incontinence","time_frame":"Through study completion, an average of 1 year","description":"Rates of surgical treatment of incontinence"},{"outcome_type":"secondary","measure":"Post-injury complications","time_frame":"3 month period post acute urethral injury","description":"Calvien-Dindo grading"}]}
{"nct_id":"NCT03352297","start_date":"2016-01-01","phase":"N/A","enrollment":48,"brief_title":"Nanofat in Post Burn Scars on the Face","official_title":"Rejuvenation of Post Burn Scars on the Face With Unfiltered Nanofat Injection","primary_completion_date":"2016-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-12-31","last_update":"2017-11-24","description":"Quasi-Experimental Study: Unfiltered Nanofat Injected into Postburn Facial Scars Number of Patients: 48 Outcome Assessed on POSAS And with Imaje J Scanning Preop And Postop Statistical Comparison of Scar Done","other_id":"249/PLS/MHL","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Post burn scars on the face\r\n\r\n          -  Fitzpatrick skin types between 3 and 4\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Hypertrophic scars\r\n\r\n          -  Contractures\r\n\r\n          -  Keloids\r\n      ","sponsor":"King Edward Medical University","sponsor_type":"Other","conditions":"Burn Scar","interventions":[{"intervention_type":"Biological","name":"Biological: Unfiltered Nanofat Graft","description":"Nanofat created from microfat, skipping the filtration step. Intradermal and subdermal injections in post burn scars on the face."}],"outcomes":[{"outcome_type":"primary","measure":"Rejuvenation of post burn scars on the face with unfiltered nanofat injection","time_frame":"1 year","description":"Pre and post-operative POSAS score"}]}
{"nct_id":"NCT02655757","start_date":"2015-12-31","phase":"Phase 4","enrollment":120,"brief_title":"Effect of Sitagliptin on Progression of Coronary Intermediate Lesion","official_title":"Effect of Sitagliptin on Progression of Coronary Intermediate Lesion in Patients With Coronary Heart Disease Complicated With Type 2 Diabetes","primary_completion_date":"2017-02-02","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-03-10","last_update":"2018-01-25","description":"This study was to investigate the Effect of Sitagliptin, a dipeptidyl peptidase-4 inhibitor, on Progression of Coronary Intermediate Lesion.","other_id":"301_xnk","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients > 18, < 80 years old, with type 2 diabetes mellitus and angiographically\r\n             proven Coronary Intermediate Lesion.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Allergy or hypersensitivity to any of the drug's components.\r\n\r\n          -  Severe liver failure, moderate or severe kidney failure\r\n\r\n          -  Malignant disease.\r\n\r\n          -  Active infectious disease.\r\n\r\n          -  Pregnancy or breastfeeding.\r\n      ","sponsor":"Li Bo","sponsor_type":"Other","conditions":"Atherosclerosis|Type 2 Diabetes Mellitus","interventions":[{"intervention_type":"Drug","name":"Drug: Sitagliptin","description":"5 mg, 1 tablet per day for 12 months"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo,1 tablet per day for 12 months"}],"outcomes":[{"outcome_type":"primary","measure":"Changes in late lumen loss of target lesion","time_frame":"Changes from baseline in late lumen loss of target lesion at 12 months","description":"A coronary intermediate lesion in Patients with coronary heart disease complicated with Type 2 Diabetes was measure with 3D QCA(3D Quantitative Coronary Angiography). To measure the changes in target lumen at 12 months."},{"outcome_type":"secondary","measure":"Incidence rate of MACE","time_frame":"Incidence rate of MACE from baseline to 12 months","description":"MACE include composite of death, myocardial infarction, or target-vessel revascularization."}]}
{"nct_id":"NCT02888353","start_date":"2015-12-31","phase":"N/A","enrollment":3700,"brief_title":"Magnetic Resonance Imaging (MRI) in Patients With Pacemakers and Implanted Cardioverter Defibrillators","official_title":"An Expanded Evaluation of the Safety of Clinically Indicated Magnetic Resonance Imaging (MRI) in Patients With Pacemakers and Implanted Cardioverter Defibrillators","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Enrolling by invitation","completion_date":"2022-02-28","last_update":"2021-04-20","description":"Ferromagnetic Implants such as permanent pacemakers (PPM's) and Implantable Cardioverter Defibrillators (ICD's) have traditionally been accepted as contraindications to Magnetic Resonance Imaging (MRI) due to safety concerns. Over the past several years, MRI safety has been established in patients with pacemakers or ICD's but only in patients in whom strict vetting procedures were implemented. These vetting procedures were initially developed to eliminate devices, leads and device/lead circumstances thought to carry increased risk. Over recent years however, objective scientific evidence has failed to support this concern raising the question as to whether or not these vetting procedures are necessary. Investigators hypothesize that in view of the existing objective scientific data, evolution of device technology and the fact that the investigators have scanned more than 2,000 devices safely (RPN03-08-11-12 and 00051707) ICD's and pacemakers and device circumstances previously excluded from MRI protocols can be safely scanned without prior vetting. This is a prospective, non randomized, cohort study. Seventeen Hundred participants with an implanted ICD or pacemaker and a clinical need for MRI will be included in the study. Unlike previous studies where strict vetting procedures were implemented pre-procedure, All patients with a pacemaker or ICD and clinical need for an MRI will be eligible for inclusion in the study provided participants meet standard MRI inclusion/exclusion safety criteria.","other_id":"IRB00068447","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":9,"maximum_age":100,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients implanted an ICD or pacemaker who have a clinical need for MR imaging\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who complete the MRI standard screening form and are deemed inappropriate for\r\n             MRI for any reason\r\n      ","sponsor":"Johns Hopkins University","sponsor_type":"Other","conditions":"Device:MRI","interventions":[{"intervention_type":"Device","name":"Device: Device: MRI","description":"Perform MRI in patients with cardiac devices"}],"outcomes":[{"outcome_type":"primary","measure":"acute patient safety and device malfunction","time_frame":"1 hour","description":"Number of participants with >30% change pre vs. post MRI in each of the following (pacing volts, sensing amplitude, battery life, and impedance (ohms), as a measure of safety"},{"outcome_type":"secondary","measure":"chronic patient safety and device malfunction","time_frame":"1 to 6 weeks","description":"Number of participants with >30% change in each of the following (pacing volts, sensing amplitude, battery life, and impedance (ohms) 1 to 6 weeks post MRI as a measure of safety"}]}
{"nct_id":"NCT02686242","start_date":"2015-12-31","enrollment":68,"brief_title":"Spinal Aesthesia in Women With Placenta Previa Percreta","official_title":"Influence of Spinal Anaesthesia on Hemodynamic Stability in Women With Placenta Previa Percreta Undergoing Caesarean Section","primary_completion_date":"2016-03-31","study_type":"Observational","rec_status":"Completed","completion_date":"2016-03-31","last_update":"2016-06-22","description":"Placenta previa percreta is a dangerous complication during surgery. Due to the high risk of hemorrhage, most parturients with placenta previa have to accept cesarean section. In this study investigators compare the effect of different anesthetic techniques on these patients.","other_id":"XJH-A-2015-6-6-01","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Probability Sample","gender":"Female","minimum_age":18,"maximum_age":65,"population":"parturients with placenta praevia/accreta scheduled for cesarean section","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  women with placenta previa and increta-percreta (diagnosed by ultrasound and/or\r\n             magnetic resonance imaging and confirmed during cesarean section)\r\n\r\n          -  women accepted cesarean section\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  women with baseline systemic blood pressure higher than 180 mmHg\r\n\r\n          -  women with coagulation disorder\r\n      ","sponsor":"Air Force Military Medical University, China","sponsor_type":"Other","conditions":"Complications; Cesarean Section","interventions":[{"intervention_type":"Procedure","name":"Procedure: spinal anesthesia","description":"bupivacaine injected by spinal puncture"},{"intervention_type":"Procedure","name":"Procedure: general anesthesia","description":"general anesthesia with intubation"}],"outcomes":[{"outcome_type":"primary","measure":"incidence of hypotension","time_frame":"from beginning of the surgery to the end of the surgery,approximately 1 hour"},{"outcome_type":"secondary","measure":"usage of norepinephrine","time_frame":"from beginning of the surgery to the end of the surgery,approximately 1 hour"},{"outcome_type":"secondary","measure":"dose of norepinephrine","time_frame":"from beginning of the surgery to the end of the surgery,approximately 1 hour"},{"outcome_type":"secondary","measure":"lowest systemic blood pressure","time_frame":"from beginning of the surgery to the end of the surgery,approximately 1 hour"},{"outcome_type":"secondary","measure":"maximal decrease of systemic blood pressure","time_frame":"from beginning of the surgery to the end of the surgery,approximately 1 hour"}]}
{"nct_id":"NCT02483988","start_date":"2015-12-31","phase":"N/A","enrollment":115,"brief_title":"The SUN Clinical Trial (Safety Utilizing NUsurface Meniscus Implant)","official_title":"The SUN Clinical Trial (Safety Utilizing NUsurface Meniscus Implant). A Multi-center, Single-arm, Prospective, Open-label, Non-randomized, Observational Clinical Study","primary_completion_date":"2021-08-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2023-06-30","last_update":"2021-08-02","description":"The NUsurface Meniscus Implant SUN Clinical Trial is a multi-center, single-arm, prospective, open label, non-randomized, observational clinical trial to gather safety and probable clinical benefit data on the NUsurface Meniscus Implant in treated the target population.","other_id":"00571","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":30,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Had > 6 months ago a medial partial meniscectomy as confirmed by patient history and\r\n             MRI\r\n\r\n          2. Has a KOOS Pain of  75 (100 being the highest attainable and no pain)\r\n\r\n          3. Is between age 30 and 75 years (inclusive) at the time of study treatment\r\n\r\n          4. Has neutral alignment 5 of the mechanical axis, as measured from the angle formed by\r\n             a line drawn from the center of the femoral head to the medial tibial spine and a line\r\n             drawn from the medial tibial spine and the center of the ankle joint\r\n\r\n          5. Has  2 mm intact medial meniscal rim capable of being fitted with a NUsurface device\r\n\r\n          6. Is able to do the study required follow-up visits, questionnaires, X-rays and MRI's\r\n\r\n          7. Is able to read and understand the English language if treated at a U.S. site or read\r\n             and understand one of the official country languages if treated at a site Outside the\r\n             U.S.\r\n\r\n          8. Is able and willing to understand and sign the Informed Consent Form\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Has a symptomatic knee because of a tear that could be addressed by a repeat partial\r\n             meniscectomy leaving > 4 mm of medial meniscus rim\r\n\r\n          2. Has evidence of a Outerbridge Grade IV cartilage loss on the medial tibial plateau or\r\n             femoral condyle that potentially could contact a NUsurface implant (e.g., a focal\r\n             lesion > 0.5 cm2 correlating to a circular defect of > 8 mm in diameter)\r\n\r\n          3. Has complete disruption of the posterior root attachment of the meniscus\r\n\r\n          4. Has lateral compartment pain and Grade III or Grade IV Outerbridge cartilage score in\r\n             the lateral compartment\r\n\r\n          5. Has a varus or valgus knee deformity > 5 requiring a tibial or femoral osteotomy\r\n\r\n          6. Has a laxity level of more than Grade II (IKDC), primary or secondary to an injury of\r\n             the anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) and/or\r\n             lateral collateral ligament (LCL) and/or medial collateral ligament (MCL)\r\n\r\n          7. Has significant trochlear dysplasia, patellar instability or symptomatic patellar\r\n             misalignment\r\n\r\n          8. Has patellar compartment pain and Grade III or Grade IV Outerbridge cartilage score in\r\n             the patellar compartment.\r\n\r\n          9. Compared to a normal knee, has obvious radiological evidence of medial femoral\r\n             squaring, anatomical variance in the medial tibial plateau, or irregularly shaped\r\n             cartilage surface\r\n\r\n         10. Had an ACL reconstruction performed < 9 months prior to study treatment\r\n\r\n         11. Has a BMI > 32.5 at the start of study treatment\r\n\r\n         12. Decides to receive (if eligible and an option) allograft medial meniscus\r\n             transplantation\r\n\r\n         13. Received any type of prosthetic knee implant made of artificial non-resorbable\r\n             plastic, metal or ceramic, not including the NUsurface Meniscus Implant\r\n\r\n         14. Has a knee flexion contracture > 10\r\n\r\n         15. Has flexion < 90\r\n\r\n         16. Had a previous medial femoral condyle surgery (not including microfracture) or High\r\n             Tibial Osteotomy (HTO)\r\n\r\n         17. Has insufficiency fractures or avascular necrosis of the medial compartment\r\n\r\n         18. Has an active infection or tumor (local or systemic)\r\n\r\n         19. Has any type of knee joint inflammatory disease including Sjogren's syndrome\r\n\r\n         20. Has neuropathic knee osteoarthropathy, also known as Charcot joint\r\n\r\n         21. Has any medical condition that does not allow possible arthroscopy of the knee\r\n\r\n         22. Has neurological deficit (sensory, motor, or reflex)\r\n\r\n         23. Is currently involved in another investigation of the lower extremity\r\n\r\n         24. Anticipates having another lower extremity surgery during the study period\r\n\r\n         25. Is contraindicated for hyaluronic acid injections (i.e., patients with known\r\n             hypersensitivity [allergy] to hyaluronan [sodium hyaluoronate] preparations); patients\r\n             having knee joint infections or skin diseases or infections in the site of possible\r\n             injections\r\n\r\n         26. Is contraindicated for corticosteroid injections (i.e., patients with allergy to any\r\n             of the components or with idiopathic thrombocytopenic purpura)\r\n\r\n         27. Has received any corticosteroid knee injections  3 months prior to study treatment\r\n\r\n         28. Has chondrocalcinosis\r\n\r\n         29. Is on immunostimulating or immunosuppressing agents\r\n\r\n         30. Has ipsilateral or contralateral lower limb joint conditions that may affect\r\n             ambulation or KOOS (e.g. have a leg length discrepancy > 2.5 cm [1 inch], causing a\r\n             noticeable limp)\r\n\r\n         31. Is a female who is lactating, expecting, or is intending to become pregnant during the\r\n             study period\r\n\r\n         32. Is an active smoker\r\n\r\n         33. Is mentally incapacitated (incapable of appraising or controlling conduct) or have\r\n             mental disability (e.g., dementia or Alzheimer's)\r\n\r\n         34. Is a prisoner\r\n\r\n         35. Is a patient who has economic incentive not to improve\r\n\r\n         36. Certain patient populations that are at high risk for poor healing or outcomes such as\r\n             patients who have a co-morbidity that reduces life expectancy to less than 36 months\r\n\r\n         37. Patients who are contraindicated for MRI (i.e., pacemaker, defibrillator, cochlear\r\n             implants, etc.)\r\n      ","sponsor":"Active Implants","sponsor_type":"Industry","conditions":"Post-Meniscectomy Pain Syndrome|Osteoarthritis, Knee","interventions":[{"intervention_type":"Device","name":"Device: NUsurface Meniscus Implant","description":"The NUsurface Meniscus Implant is a Polycarbonate-Urethane (PCU)-based device reinforced with high tensile Ultra High Molecular Weight Polyethylene (UHMWPE) fibers. The product is available in different sizes, left and right, and with trials so as to allow the surgeon several size options for implantation. The NUsurface Meniscus Implant, is designed to be conceptually analogous to the natural meniscus whose structural characteristics include a highly orientated collagen fiber network that supports the large hoop stresses to produce better distribution of contact pressures within the knee joint. Restoring the distribution of joint loads post-meniscectomy is thought to reducing joint overload and to reducing pain."}],"outcomes":[{"outcome_type":"primary","measure":"Safety assessed by Serious and non-serious, device-related and non-device related adverse events","time_frame":"2 years","description":"Safety assessed by Serious and non-serious, device-related and non-device related adverse events recorded during the implantation, up to 24 months following implantation"},{"outcome_type":"primary","measure":"Clinical Performance","time_frame":"2 years","description":"Evaluation of performance defined as NUsurface® Meniscus Implant providing knee pain reduction and improvement in functionality and quality of life up to 24 months post-implantation, as measured by KOOS Pain and KOOS 5"},{"outcome_type":"secondary","measure":"Safety assessed by Serious and non-serious, device-related and non-device related adverse events","time_frame":"5 years","description":"Safety assessed by Serious and non-serious, device-related and non-device related adverse events occurring between 24 and 60 months following implantation"},{"outcome_type":"secondary","measure":"Clinical Performance","time_frame":"5 years","description":"Evaluation of performance defined as NUsurface® Meniscus Implant providing knee pain reduction and improvement in functionality and quality of life up to 60 months post-implantation, as measured by KOOS Pain and KOOS 5"}]}
{"nct_id":"NCT02588638","start_date":"2015-12-31","enrollment":100,"brief_title":"Next Generation Sequencing Diagnostics - On the Road to Rapid Diagnostics for Rare Diseases","official_title":"Next Generation Sequencing Diagnostics - On the Road to Rapid Diagnostics for Rare Diseases","primary_completion_date":"2022-06-30","study_type":"Observational [Patient Registry]","rec_status":"Recruiting","completion_date":"2023-09-30","last_update":"2020-11-13","description":"In the study, NextGen SE are on-hand a cohort comprising each 50 pediatric and 50 adult patients, and in which there are an unclear movement disorder or an unclear cognitive disorder, examines the following questions : Primary: - Number of diagnoses made by NGS Secondary: 1. restriction of the quality of life by unclear disease 2. Cost of not purposeful preliminary diagnostics ( beyond the minimal diagnostic data set ) 3. Impact of the diagnosis to therapy and follow-up examinations 4. Time to diagnosis","other_id":"NextGen-SE","observational_model":"Other","time_perspective":"Other","sampling_method":"Non-Probability Sample","gender":"All","population":"Patients with unclear diagnoses","criteria":"\n        Inclusion Criteria:\r\n\r\n        For patients> 18 years\r\n\r\n          1. Unclear movement disorder\r\n\r\n             o Progressive ataxia after minimal exclusion diagnostics: magnetic resonance\r\n             tomography (MRT) (structural lesions such as cerebellar tumor, malformation)\r\n             Laboratory (Vitamin B12, thyroid peroxidase (TPO) antibodies, glutamate decarboxylase\r\n             (GAD) II-antibodies (AK) In medullary lesions: Liquor exclusion Friedreich ataxia\r\n             (FRDA) and spinocerebellar ataxia type (SCA)1-2-3-6\r\n\r\n             o Progressive para-spasticity by minimal exclusion diagnostics: MRT neuro axis\r\n             (structural lesions such as cervical myelopathy) Laboratory (Vitamin B12, human T-cell\r\n             lymphotrophic virus ((HTLV)-AK) In medullary lesions: Liquor\r\n\r\n          2. Unclear cognitive decline o After minimal exclusion diagnosis MRT (intracranial\r\n             pressure, focal brain lesions explanatory) laboratory (Thyroid-stimulating hormone\r\n             (TSH), TPO-AK, antibody profile limbic encephalitis) Liquor (inflammation, meningitis)\r\n             Electroencephalography (EEG) (Status) Exclusion chromosome 9 open reading frame 72\r\n             (C9orf72)\r\n\r\n        For patients <18 years Patients with (penetrating) suspected cerebral neurogenetic diseases\r\n\r\n          -  Unclear movement disorder (spasticity, ataxia, dyskinesia)\r\n\r\n          -  Unclear cognitive disorder with probability of monogenic origin\r\n\r\n          -  Fragile X Syndrome (Fra-X) at mentally retarded boy, Friedreich ataxia (FRDA) with\r\n             ataxia should be genetically excluded\r\n\r\n        Exclusion Criteria:\r\n\r\n        For patients > 18 years\r\n\r\n          1. Lack of consent\r\n\r\n          2. symptom onset > 40 years of age\r\n\r\n          3. Sudden, abrupt beginning\r\n\r\n          4. As early as previous history of genetic diagnosis using next-generation sequencing\r\n             (NGS), also in the form of a panel\r\n\r\n        For patients <18 years\r\n\r\n          1. injury brain disorders\r\n\r\n               -  On the basis of imaging\r\n\r\n               -  On the basis of medical history (premature baby, hypoxic-ischemic encephalopathy)\r\n\r\n          2. Inflammatory brain disorders\r\n\r\n               -  On the basis of imaging\r\n\r\n               -  On the basis of laboratory parameters (Oligoclonal fractions, cerebrospinal fluid\r\n                  (CSF) cell count increased)\r\n\r\n          3. Light, isolated mental developmental disorder or behavioral disorder (rare\r\n             monogenetic) - (less than 2 standard deviartion of normal or - < 6 year olds - less\r\n             than 1 year in development history back)\r\n\r\n          4. Sudden , abrupt beginning\r\n\r\n          5. Next-generation sequencing (NGS) also in the form of a panel\r\n      ","sponsor":"University Hospital Tuebingen","sponsor_type":"Other","conditions":"Movement Disorder|Cognitive Decline","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Number of diagnoses made by next gereration sequency (NGS)","time_frame":"Within the study period of 18 months"},{"outcome_type":"secondary","measure":"Restriction of the quality of life by unclear disease measured rated by Quality of Life Questionnaire (EQ5D), Depression Questionnaire (PHQ)","time_frame":"At day 1","description":"EQ-5D: Calculation preference value PHQ: Categorical analysis carried out by modified evaluation algorithms of the Diagnostic and Statistical Manual of Mental Disorders (DSM) -IV B"},{"outcome_type":"secondary","measure":"Cost of not purposeful preliminary diagnostics rated by questionnaire on costs (number of outpatient performances, stationary investigations, repetition 's imaging, genetic single diagnostics, high-priced diagnostic","time_frame":"At day 1"},{"outcome_type":"secondary","measure":"Time to diagnosis","time_frame":"At day 1","description":"For patients whose diagnosis can be made by NGS"}]}
{"nct_id":"NCT02596048","start_date":"2015-12-31","phase":"Phase 4","enrollment":224,"brief_title":"A Multicenter Study of Iomeron-400 Used With Multi-detector Computed Tomography Angiography (MDCTA)","official_title":"A Phase IV Multicenter Study of Iomeron-400 Used With Multi-detector Computed Tomography Angiography (MDCTA) of the Thoraco-Abdominal Aorta, and the Carotid, Pulmonary, and Peripheral Arteries","primary_completion_date":"2017-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-04-30","last_update":"2017-06-02","description":"This is a Phase IV multicenter, open-label study and is being implemented in order to assess diagnostic image quality of MDCTA in subjects undergoing computed tomography angiography (CTA) of the thoraco-abdominal aorta, and the carotid, pulmonary and peripheral arteries with IOMERON.","other_id":"IOM-122","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Provides written Informed Consent and is willing to comply with protocol requirements\r\n\r\n          2. Is at least 18 years of age.\r\n\r\n          3. Is scheduled to undergo an elective thoraco-abdominal aorta, carotid, pulmonary or\r\n             peripheral MDCTA examination.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Is a pregnant or lactating female. Exclude the possibility of pregnancy:\r\n\r\n             by testing on site at the institution (serum or urine HCG) within 24 hours prior to\r\n             the start of investigational product administration, by surgical history (e.g., tubal\r\n             ligation or hysterectomy),post-menopausal with a minimum 1 year without menses;\r\n\r\n          2. Has any known allergy to one or more of the ingredients of IOMERON or a history of\r\n             hypersensitivity to iodinated contrast agents;\r\n\r\n          3. Has moderate to severe renal impairment;\r\n\r\n          4. Has received an investigational compound and/or medical device within 30 days before\r\n             admission into this study;\r\n\r\n          5. Has been enrolled previously to this study\r\n\r\n          6. Has any medical condition or other circumstances which would significantly decrease\r\n             the chances of obtaining reliable data, achieving study objectives, or completing the\r\n             study and/or post-dose follow-up examinations.\r\n      ","sponsor":"Bracco Diagnostics, Inc","sponsor_type":"Industry","conditions":"Aortic Disorders|Carotid Disease|Pulmonary Disease|Peripheral Artery Disease","interventions":[{"intervention_type":"Other","name":"Other: Iomeron","description":"Iomeron or Imeron which is a iomeprol injection, hereafter referred to as iomeprol is an injectable solution of iomeprol, a non-ionic hydrosoluble iodinated compound used as a medical imaging contrast agent for radiological examinations."}],"outcomes":[{"outcome_type":"primary","measure":"Number of participants with an 3 point scoring system used for assessing diagnostic image quality","time_frame":"2 hours","description":"0 = Insufficient: Impaired image quality precludes adequate diagnostic assessment of vascular abnormalities (stenosis, embolism, dissection, etc.) because of severe noise, or severe artifacts, or insufficient contrast enhancement.\r\n= Adequate: Image quality is sufficient for adequate diagnostic assessment of vascular abnormalities (stenosis, embolism, dissection etc.), even in presence of minimal noise, or minimal artifacts and sufficient contrast enhancement.\r\n= Good: Image quality allows adequate, complete and rapid diagnostic assessment of vascular abnormalities (stenosis, embolism, dissection etc.) with absent or very minimal noise, or absent or very minimal artifacts, and optimal contrast enhancement."},{"outcome_type":"primary","measure":"Number of participants with an 3 point scoring system used for visual assessment of contrast enhancement and delineation of vascular structures/abnormalities","time_frame":"2 hours","description":"0 = Insufficient: Generally poor enhancement and delineation of major vascular structures/abnormalities (e.g. major endoleaks, aneurysms, bleeding, etc.).\r\n= Adequate: Sufficient enhancement and delineation of vascular structures/abnormalities (e.g. small bleeding, endoleaks, etc).\r\n= Good: Optimal enhancement and complete delineation of vascular structures/abnormalities (e.g. small bleeding, endoleaks, etc)."},{"outcome_type":"secondary","measure":"Comparing number of participants undergoing x-ray angiography as the truth standard with the diagnostic performance of MDCTA diagnosis using a two point scoring system","time_frame":"2 hours","description":"0 = Inadequate: Relevant aspects of MDCTA diagnosis do not match with the truth standard\r\n1 = Adequate: Relevant aspects of the MDCTA diagnosis match with the truth standard"}]}
{"nct_id":"NCT02888392","start_date":"2015-12-18","phase":"N/A","enrollment":60,"brief_title":"The Effect of Zespri Green Kiwifruit on Digestive and Gut Health Functions","official_title":"The Effect of Zespri Green Kiwifruit on Digestive and Gut Health Functions: a Multi-country, Randomized, Cross-over Clinical Intervention","primary_completion_date":"2017-01-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-01-30","last_update":"2017-07-02","description":"The proposed study will primarily demonstrate the efficacy of kiwifruit as a food intervention for the relief of constipation and associated symptoms in functionally constipated adults, and those with IBS-C. Secondary measures will show the consumption of kiwifruit will result in improvements in gastro-intestinal discomfort levels of adults with IBS-C.","other_id":"HN1525","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        The study group will consist of 3 balanced groups of 20 subjects. A functionally\r\n        constipated group (FC), an irritable bowel syndrome with constipation group (IBS-C), and a\r\n        healthy control group (HC). The FC and IBS-C groups are the study population of interest to\r\n        measure improvements in digestive comfort, and the HC will ensure no adverse events,\r\n        confirming kiwifruit are suitable for consumption by the general healthy population.\r\n\r\n        All participants must fall within:\r\n\r\n          1. Adult (18-65 years). Females will be required to declare stage of menstrual cycle\r\n             during the different trial phases.\r\n\r\n          2. BMI between 18-35 Screening questionnaires for participant selection, together with\r\n             the sample ROME III FC/ IBS-C criteria screening questions are provided in Appendix C.\r\n             This questionnaire enables potential participants to be screened for both FC and\r\n             IBS-C, together with some \"red flag\" questions to further determine participant\r\n             suitability.\r\n\r\n        Inclusion Criteria:\r\n\r\n          -  The functionally constipated (FC) study participant group will be selected based on\r\n             the following criteria:\r\n\r\n               1. Presence of functional constipation according to ROME III diagnostic criteria*5b\r\n                  i. Must include two or more of the following:\r\n\r\n                    1. Straining during at least 25% of defecations\r\n\r\n                    2. Lumpy or hard stools in at least 25% of defecations\r\n\r\n                    3. Sensation of incomplete evacuation for at least 25% of defecations\r\n\r\n                    4. Sensation of anorectal obstruction/blockage for at least 25% of defecations\r\n\r\n                    5. Manual manoeuvres to facilitate at least 25% of defecations (e.g. digital\r\n                       evacuation, support of pelvic floor)\r\n\r\n                    6. Fewer than three defecations per week ii. Loose stools are rarely present\r\n                       without the use of laxatives iii. Insufficient criteria for irritable bowel\r\n                       syndrome * Criteria fulfilled for the last 3 months with symptom onset at\r\n                       least 6 months prior to diagnosis\r\n\r\n               2. Participants with IBS-C (mild). The diagnostic criteria * for Irritable Bowel\r\n                  Syndrome5a is:\r\n\r\n                  Recurrent abdominal pain or discomfort** at least 3 days per month in the last 3\r\n                  months associated with 2 or more of the following:\r\n\r\n                  i. Improvement with defecation ii. Onset associated with a change in frequency of\r\n                  stool iii. Onset associated with a change in form (appearance of stool)\r\n\r\n                  * Criteria fulfilled for the last 3 months with symptom onset at least 6 months\r\n                  prior to diagnosis\r\n\r\n                  ** Discomfort means an uncomfortable sensation not described as pain. In\r\n                  pathophysiology research and clinical trials, a pain/discomfort frequency of at\r\n                  least 2 days a week during screening evaluation for subject eligibility.\r\n\r\n                  IBS-C requires meeting the IBS criteria together with - hard or lumpy stools\r\n                  (Bristol Stool Form Scale 1-2)  25%, and loose or mushy stools  25% of bowel\r\n                  movements (Bristol Stool Form Scale 6-7).\r\n\r\n                  Exclusion Criteria:\r\n\r\n          -  Potential participants will be excluded if they have any alarm features associated\r\n             with bowel habit (recent changes in bowel habit (<3 months), rectal bleeding, weight\r\n             loss, occult blood in stools, anaemia), anal fissures, bleeding haemorrhoids, and\r\n             family history of GI cancer or IBD.\r\n\r\n        Chronic disease (cardiovascular, cancer, renal failure, previous gastrointestinal surgery\r\n        (not including appendectomy or cholecystectomy), neurological conditions (e.g. multiple\r\n        sclerosis, spinal chord injury, stroke).\r\n\r\n        All patients will be screened at recruitment for fasting blood glucose. Those with results\r\n         7.2 mmol/l will not be accepted into the trial.\r\n\r\n        Participants with diagnosed and stable conditions requiring the use of SSRI's (selective\r\n        serotonin reuptake inhibitors), tricyclates, opiates or anti-inflammatories will be\r\n        permitted into the trial on condition the medication has been in use continually and the\r\n        condition has been stable for > 3 months. Similarly those with stable and controlled\r\n        diabetes (> 3 months) will be permitted to participate.\r\n\r\n        Women who are pregnant, breastfeeding or planning a pregnancy in the 3 months post\r\n        selection (trial period) will be excluded.\r\n\r\n        Potential participants with known kiwifruit or latex allergy will be excluded.\r\n      ","sponsor":"Zespri International Limited","sponsor_type":"Industry","conditions":"Irritable Bowel Syndrome","interventions":[{"intervention_type":"Other","name":"Other: Kiwifruit","description":"2 green kiwifruit cultivar 'Hayward'"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Psyllium","description":"Pysllium seed husk; ispaghula, isabgol, or psyllium, are portions of the seeds of the plant Plantago ovata, (genus Plantago), a native of India, Bangladesh and Pakistan. They are hygroscopic, which allows them to expand and become mucilaginous. Psyllium is a faecal bulking agent used to treat constipation. It absorbs liquid in the intestines, swells and forms a bulky soft stool that is easy to pass"}],"outcomes":[{"outcome_type":"primary","measure":"Complete Spontaneous Bowel Motions","time_frame":"Total study duration per participant of 16 weeks. CSBM was assessed weekly from 2 week lead-in before baseline and every week through intervention 1, wash-out, intervention 2 and for a two week follow-up period .","description":"A spontaneous bowel motion not induced by rescue medication and associated with a sense of complete evacuation"},{"outcome_type":"secondary","measure":"Daily Bowel Habit","time_frame":"Total study duration per participant of 16 weeks. Daily bowel habit was assessed daily from 2 week lead-in before baseline and every day through intervention 1, wash-out, intervention 2 and for a two week follow-up period .","description":"Frequency of bowel movements, ease of defaecation, stool form"},{"outcome_type":"secondary","measure":"Weekly Gastrointestinal Symptom Rating Scale (GSRS)","time_frame":"Total study duration per participant of 16 weeks. GSRS was assessed weekly from 2 week lead-in before baseline and every week through intervention 1, wash-out, intervention 2 and for a two week follow-up period .","description":"Gastrointestinal Symptom Rating Scale"},{"outcome_type":"secondary","measure":"Rome III","time_frame":"Total study duration per participant of 16 weeks. Rome III was assessed at the start of the study, 2 weeks later at baseline, and at the end of each study period i.e. after intervention 1, wash-out, intervention 2 and at the end of a 2 week follow up .","description":"Rome III questionnaire to establish patient group as Healthy, FC, or IBS-C"},{"outcome_type":"secondary","measure":"Irritable Bowel Syndrome Quality of Life (IBS-QoL) evaluation","time_frame":"Total study duration per participant of 16 weeks. Rome III was assessed at baseline, and at the end of each study period i.e. after intervention 1, wash-out, and the end of intervention 2.","description":"Validated quality of life questionnaire"},{"outcome_type":"secondary","measure":"Profile of Mood Score (POMS)","time_frame":"Total study duration per participant of 16 weeks. POMS was assessed at baseline, and at the end of each study period i.e. after intervention 1, wash-out, intervention 2 and at the end of a 2 week follow up .","description":"Validated mood score questionnaire"},{"outcome_type":"secondary","measure":"Irritable Bowel Syndrome severity score index (IBS-SSI)","time_frame":"IBS-SSI was completed once at enrollment","description":"Validated questionnaire to score severity of IBS to assign participants to correct group"},{"outcome_type":"secondary","measure":"3-day Food Diary","time_frame":"Total study duration per participant of 16 weeks. The food diary was done at baseline, and at the end of each study period i.e. after intervention 1, wash-out, and intervention 2","description":"3 day recall diet record to establish diet remains consistent throughout study"}]}
{"nct_id":"NCT02600494","start_date":"2015-12-15","phase":"Phase 3","enrollment":554,"brief_title":"Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression","official_title":"Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of ITI-007 Monotherapy in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder","primary_completion_date":"2019-01-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-07-24","last_update":"2021-04-14","description":"The study will evaluate the efficacy and safety of ITI-007 (Lumateperone) in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode. The study will be conducted in two parts, Part A and Part B. Part A is a randomized, double-blind, placebo-controlled study. In Part B, patients who safely complete participation in part A may be enrolled in an open-label extension.","other_id":"ITI-007-401","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Major Inclusion Criteria:\r\n\r\n          -  male or female subjects of any race, ages 18-75 inclusive, with a clinical diagnosis\r\n             of Bipolar I or Bipolar II disorder\r\n\r\n          -  experiencing a current major depressive episode\r\n\r\n        Major Exclusion Criteria:\r\n\r\n          -  any subject unable to provide informed consent\r\n\r\n          -  any female subject who is pregnant or breast-feeding\r\n\r\n          -  any subject judged to be medically inappropriate for study participation\r\n      ","sponsor":"Intra-Cellular Therapies, Inc.","sponsor_type":"Industry","conditions":"Bipolar Depression","interventions":[{"intervention_type":"Drug","name":"Drug: ITI-007 (Lumateperone)"},{"intervention_type":"Drug","name":"Drug: Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"Montgomery-Åsberg Depression Rating Scale (MADRS)","time_frame":"6 weeks"}]}
{"nct_id":"NCT03446716","start_date":"2015-12-01","phase":"N/A","enrollment":27,"brief_title":"Sleep Extension and Behavior of Young Children","official_title":"Effects of Sleep Extension on Sleep Physiology and Behavior of Young Children","primary_completion_date":"2017-08-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-08-01","last_update":"2018-02-27","description":"This pseudo-randomized intervention study examined change in inhibitory control following a sleep manipulation in which children with and without ADHD were instructed to advance their bedtime by 90 minutes for five days.","other_id":"2015-2739","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Participants are assigned to the ADHD or Typically Developing group based on diagnosis history. Each then completes the intervention (EXTENSION) either preceded or followed by a week of baseline sleep (CONTROL). The order is pseudo-randomized.","sampling_method":"","gender":"All","minimum_age":6,"maximum_age":9,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  A subset of children were required to have an ADHD diagnosis\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  diagnosis of intellectual disabilities or developmental delay\r\n\r\n          -  current diagnosis of history of sleep disorder\r\n\r\n          -  uncorrected hearing or visual impairments\r\n      ","sponsor":"University of Massachusetts, Amherst","sponsor_type":"Other","conditions":"Attention Deficit Hyperactivity Disorder","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Sleep Extension","description":"Child attempted to go to bed 90 mins in advance of their normal bedtime."}],"outcomes":[{"outcome_type":"primary","measure":"total sleep time","time_frame":"5 days (actigraph watch is worn for 5 days in each condition and overnight sleep time is identified and averaged across these 5 days)","description":"average nightly across 5 nights"},{"outcome_type":"secondary","measure":"inhibitory control","time_frame":"measured before and after sleep - about 12 hrs","description":"measured with the Go/NoGo task"}]}
{"nct_id":"NCT02605161","start_date":"2015-11-30","enrollment":17,"brief_title":"Imaging Blood Brain Imaging Dysfunction in Parkinson's Disease","official_title":"Imaging Blood Brain Imaging Dysfunction in Parkinson's Disease","primary_completion_date":"2020-09-08","study_type":"Observational","rec_status":"Completed","completion_date":"2020-09-08","last_update":"2020-12-31","description":"The purpose of this study is to evaluate the blood brain barrier in the striatum of patients that have other types of movement disorders compared to patients with Parkinson's Disease that are receiving similar treatment, to determine if a there is a disruption of the blood brain barrier in patients with Parkinson's Disease.","other_id":"20150770-01H","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","population":"Patients having movement disorders undergoing deep brain stimulation (DBS) of the internal\r\n        segment of the globus pallidus for treatment of motor symptoms refractory to medical\r\n        therapy at the Ottawa Hospital, Civic Campus, will be recruited to participate in this\r\n        pilot study. The cohort will include 10 PD patients and 10 control subjects. The PD\r\n        subjects will have received a diagnosis of PD using established clinical criteria following\r\n        clinical assessment at the Movement Disorders Clinic of The Ottawa Hospital. The 10 control\r\n        subjects will consist of those undergoing DBS and assessed in the same clinic with a\r\n        clinical diagnosis of either essential tremor or cervical dystonia.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Disease burden is dominated by motor symptoms such as rigidity, bradykinesia,\r\n             akinesia, and tremor;\r\n\r\n          -  Medications have been optimized by a movement disorder neurologist;\r\n\r\n          -  Adequate social support to assist with preoperative recovery and problems during\r\n             subsequent programming;\r\n\r\n          -  No major mood disorder and any mood disorders are medically optimized;\r\n\r\n          -  No major cognitive impairment;\r\n\r\n          -  No underlying medical conditions that would preclude surgery;\r\n\r\n          -  Adequate response to levodopa, as assessed by UPDRS-3 on and off levodopa. All\r\n             participants has at least a 30% improvement;\r\n\r\n          -  eGRF>30\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Disease burden is not dominated by motor symptoms such as rigidity, bradykinesia,\r\n             akinesia, and tremor;\r\n\r\n          -  Medications have not bee optimized by a movement disorder neurologist;\r\n\r\n          -  There is not adequate social support to assist with pre-operative recovery or problems\r\n             during subsequent programming;\r\n\r\n          -  Presence of major mood disorders or any mood disorders not medically optimized;\r\n\r\n          -  Presence of major cognitive impairment;\r\n\r\n          -  Presence of underlying medical conditions that would preclude surgery;\r\n\r\n          -  Inadequate response to levodopa;\r\n\r\n          -  eGFR<30\r\n      ","sponsor":"Ottawa Hospital Research Institute","sponsor_type":"Other","conditions":"Parkinson's Disease|Movement Disorders","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Degree of contrast enhancement","time_frame":"one year","description":"Pre-contrast images will be used as mask images and will be digitally substracted from post-contrast images to obtain the \"difference\" images. From the \"difference images\", two neuroradiologists blinded to the clinical status of the patient will assess the degree enhancement in the striatum (none,mild, moderate, marked)."},{"outcome_type":"secondary","measure":"Permeability of blood brain barrier in the striatum","time_frame":"one year","description":"Quantitative assessment of the permeability of the blood brain barrier in the striatum will be assessed using dynamic contrast enhanced MRI. Specifically, the volume transfer constant (Ktrans) will be measured from the striatum in the control and patient groups."}]}
{"nct_id":"NCT02712333","start_date":"2015-11-30","phase":"N/A","enrollment":60,"brief_title":"Health Effects of Indoor Air Filtration in Healthy Chinese Adults","official_title":"Health Effects of Indoor Air Filtration in Healthy Chinese Adults: An Intervention Study","primary_completion_date":"2015-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-06-30","last_update":"2017-10-02","description":"This study aims to detect serum metabolite changes, as well as other health indicators with the intervention of air purifiers on a randomized, crossover, double-blind trial.","other_id":"FDEH-AF2015","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":30,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy university students in Jiangwan Campus, Fudan university\r\n\r\n          -  Non-smoking, no history of alcohol or drug abuse\r\n\r\n          -  Free of chronic cardiovascular, respiratory, liver and kidney disease\r\n\r\n          -  Spend at least 50% (weekdays) or 80% (weekends) of time indoors\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Current or ever smokers\r\n\r\n          -  History of asthma, chronic bronchitiscough, hypertension or other chronic\r\n             inflammatory disease\r\n\r\n          -  acute infections\r\n\r\n          -  medication use in recent one month\r\n      ","sponsor":"Fudan University","sponsor_type":"Other","conditions":"Blood Pressure","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Air Purifiers","description":"The 17 dormitory rooms and their residents were randomized into two groups: the intervention and control group. The intervention group went through a 9-day intervention with an air purifier placed in the center of the room. All rooms in this group used the same qualified air purifiers (model KJEA200e, 3M), and all participants were required to stay in their dormitory rooms with the windows/doors closed throughout intervention period. All participants and research staffs were blinded to the group assignment."},{"intervention_type":"Behavioral","name":"Behavioral: Sham Air Purifiers","description":"The control group went through a 9-day intervention with a sham air purifier (with its filter gauze removed) placed in the center of the room. All rooms used the same air purifiers (model KJEA200e, 3M) as the intervention group, except the filter gauze was removed. During the study period all participants were required to stay in their dormitory rooms with the windows/doors closed. All participants and research staffs were blinded to the group assignment."}],"outcomes":[{"outcome_type":"primary","measure":"Changes of Serum Cortisol Levels","time_frame":"at the end of each 9-day intervention period","description":"Using metabolomic methods to screen and quantify all the serum metabolites, and calculate changes in main metabolites in sham purification compared to real purification.\r\nRelative intensity was calculated by dividing the peak intensity of cortisol with the peak intensity of internal standard (2-chloro-D-phenylalanine methanol solution, 0.014mg/mL)"},{"outcome_type":"primary","measure":"Changes of Serum Cortisone Concentration","time_frame":"at the end of each 9-day intervention period","description":"Use metabolomic methods to screen and quantify all the serum metabolites, and calculate changes in main metabolites in sham purification compared to real purification.\r\nRelative intensity was calculated by dividing the peak intensity of cortisone with the peak intensity of internal standard (2-chloro-D-phenylalanine methanol solution, 0.014mg/mL)"},{"outcome_type":"primary","measure":"Changes of Serum Epinephrine Concentrations","time_frame":"at the end of each 9-day intervention","description":"Use metabolomic methods to screen and quantify all the serum metabolites, and calculate changes in main metabolites in sham purification compared to real purification.\r\nRelative intensity was calculated by dividing the peak intensity of epinephrine with the peak intensity of internal standard (2-chloro-D-phenylalanine methanol solution, 0.014mg/mL)"},{"outcome_type":"primary","measure":"Changes of Serum Norepinephrine Concentration","time_frame":"at the end of each 9-day intervention","description":"Use metabolomic methods to screen and quantify all the serum metabolites, and calculate changes in main metabolites in sham purification compared to real purification.\r\nRelative intensity was calculated by dividing the peak intensity of cortisol with the peak intensity of internal standard (2-chloro-D-phenylalanine methanol solution, 0.014mg/mL)"},{"outcome_type":"secondary","measure":"Systolic Blood Pressure","time_frame":"at the end of each 9-day intervention period","description":"To eliminate possible error, blood pressure for each participant were conducted by the same working staff using the same instrument. Average levels were calculated by treatments (intervention or control)."},{"outcome_type":"secondary","measure":"Diastolic Blood Pressure","time_frame":"at the end of each 9-day intervention","description":"To eliminate possible error, blood pressure for each participant were conducted by the same working staff using the same instrument. Average levels were calculated by treatments (intervention or control)."},{"outcome_type":"secondary","measure":"Pulse Pressure","time_frame":"at the end of each 9-day intervention","description":"To eliminate possible error, blood pressure for each participant were conducted by the same working staff using the same instrument. Average levels were calculated by treatments (intervention or control)."}]}
{"nct_id":"NCT02056574","start_date":"2015-11-30","phase":"Phase 2","enrollment":0,"brief_title":"Safety and Efficacy Study of a Single Dose of NA-1 in Patients Undergoing Endovascular Repair of Ruptured Aneurysms","official_title":"Phase 2, Multicenter Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study Evaluating a Single Dose of Intravenous NA-1 in Patients With Subarachnoid Hemorrhage Undergoing Endovascular Repair of Ruptured Intracranial Aneurysms","primary_completion_date":"2019-11-30","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2020-04-30","last_update":"2015-08-04","description":"This is a randomized, double-blind, placebo-controlled, single-dose study investigating the safety and efficacy of NA-1 in patients with subarachnoid hemorrhage (SAH) undergoing endovascular repair of ruptured intracranial aneurysms. Up to 300 male and female patients with SAH undergoing endovascular repair of a ruptured intracranial aneurysm will be dosed with 2.60 mg/kg of NA-1 or placebo as a 10 minute intravenous infusion after completion of the endovascular procedure on Day 1 of the study period. Subjects will undergo interim procedures at Day 2-4, Day 30-45, and end-of-study procedures on Day 90.","other_id":"NA-1-006","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  1. A diagnosis of a ruptured brain aneurysm deemed suitable for repair by\r\n             neuroendovascular techniques involving intraluminal occlusion by detachable platinum\r\n             coils, or any neuroendovascular technique such as balloon-assisted coiling, stenting,\r\n             or flowed diversion.\r\n\r\n          -  2. Patient should be Grade II-IV on the WFNS grading scale for SAH.\r\n\r\n          -  3. Male or female with a minimum age of 18 years on the day of enrolment.\r\n\r\n          -  4. Female subjects of childbearing potential: Negative pregnancy test.\r\n\r\n          -  5. Non-surgically sterile males or males with partners of childbearing potential must\r\n             be willing to use condoms with spermicide for 3 months after completion of dosing.\r\n\r\n          -  6. Body weight less than or equal to 180 kg.\r\n\r\n          -  7. Vital signs on admission:\r\n\r\n               -  Blood pressure between 80-180 mm Hg systolic/50-100 mm Hg diastolic;\r\n\r\n               -  Body temperature  38.5C.\r\n\r\n          -  8. Informed consent and availability of the subject for the entire study period and\r\n             willingness of the subject to adhere to protocol requirements.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  1. Prior SAH within 6 months of presentation.\r\n\r\n          -  2. Dissecting or mycotic brain aneurysm.\r\n\r\n          -  3. Planned endovascular vessel sacrifice as the primary modality for aneurysm\r\n             treatment.\r\n\r\n          -  4. Known history of life-threatening allergic reaction to any medication.\r\n\r\n          -  5. Chronic renal disease defined as a baseline serum creatinine > 150 mol/L.\r\n\r\n          -  6. Women who are pregnant, or have a positive urine or blood (-hCG) pregnancy test.\r\n\r\n          -  7. Women who are breastfeeding.\r\n\r\n          -  8. Any clinically significant psychiatric or psychological disease, which would\r\n             preclude the patient from completing the protocol.\r\n\r\n          -  9. Pre-morbid (estimated) modified Rankin scale score of >1.\r\n\r\n          -  10. Previous major stroke.\r\n\r\n          -  11. Patients with known HIV infection.\r\n\r\n          -  12. Participation in a clinical trial with an investigational drug within 30 days\r\n             preceding this study.\r\n\r\n          -  13. Previous participation in the ENACT trial (e.g, to treat a prior aneurysm),\r\n             participation in another trial involving NA-1 or prior receipt of NA-1.\r\n\r\n          -  14. Any other medical condition that the site investigator deems would put the patient\r\n             at excessive risk of participation in the study or an expected life expectancy less\r\n             than 1 year or that would result in inability to collect clinical outcomes at 90 days.\r\n      ","sponsor":"NoNO Inc.","sponsor_type":"Industry","conditions":"Subarachnoid Hemorrhage|Ruptured Intracranial Aneurysm","interventions":[{"intervention_type":"Drug","name":"Drug: NA-1"},{"intervention_type":"Drug","name":"Drug: Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"Modified Rankin Scale (mRS)","time_frame":"90 days","description":"Proportion of subjects achieving independent functioning as defined as a score of 0-1 on the mRS at Day 90."},{"outcome_type":"secondary","measure":"Modified Rankin Scale (mRS)","time_frame":"30-45 days","description":"Proportion of subjects achieving a good outcome as defined as a score of 0-1 on the mRS at Day 30-45."},{"outcome_type":"secondary","measure":"National Institutes of Health Stroke Scale (NIHSS)","time_frame":"90 days","description":"Proportion of subjects achieving a good outcome as defined as a score of 0-1 on the NIHSS at Day 90."},{"outcome_type":"secondary","measure":"Mortality","time_frame":"90 days","description":"Rate of subarachnoid hemorrhage related mortality over the 90 day study period."},{"outcome_type":"secondary","measure":"In-hospital length of stay","time_frame":"90 days","description":"Duration of in-hospital length of stay."}]}
{"nct_id":"NCT02610010","start_date":"2015-11-30","phase":"Phase 3","enrollment":462,"brief_title":"Intensity-modulated Radiotherapy With or Without Concurrent Chemotherapy for Stage II Nasopharyngeal Carcinoma","official_title":"Intensity-modulated Radiotherapy With or Without Concurrent Chemotherapy for Stage II Nasopharyngeal Carcinoma: a Phase 3 Non-inferior Multicenter Randomized Controlled Trial","primary_completion_date":"2022-11-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2025-11-30","last_update":"2015-11-20","description":"A prior phase III randomized trial showed considerable survival benefit from the combined treatment of cisplatin-based concurrent chemotherapy and two-dimensional conventional radiotherapy (2DCRT) for patients with stage II (the Chinese 1992 staging system) nasopharyngeal carcinoma. However, since intensity-modulated radiotherapy (IMRT) was known to be superior to 2DCRT in local control, progression free survival and even overall survival, it is a pivotal question whether stage II [T1N1M0 and T2N0-1M0, based on the 2010 International Union against Cancer/American Joint Committee on Cancer (UICC/AJCC) staging system] patients can still obtain significant benefit from the additional concurrent chemotherapy in the IMRT era. The investigators' retrospective study (PMID:26528755 ) indicated that low risk nasopharyngeal carcinoma (T1N1M0, T2N0-1M0 or T3N0M0, the 2010 UICC/AJCC staging system) patients who underwent IMRT could not benefit from cisplatin-based concurrent chemotherapy. Therefore, the investigators perform this randomized controlled trial to address this question, on a prudent assumption that IMRT alone was not inferior to IMRT plus concurrent chemotherapy in stage II patients.","other_id":"2015-FXY-066-Dept. of RT","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Newly histologically confirmed non-keratinizing (WHO 1991) nasopharyngeal carcinoma.\r\n\r\n          -  Tumor staged as T1N1M0 or T2N0-1M0 (the 2010 UICC/AJCC staging system).\r\n\r\n          -  Karnofsky scale (KPS)  70.\r\n\r\n          -  Adequate marrow: leucocyte count  410E9/L, hemoglobin  110g/L and platelet count \r\n             10010E9/L.\r\n\r\n          -  Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase\r\n             (AST) and bilirubin  1.5upper limit of normal (ULN) concomitant with alkaline\r\n             phosphatase (ALP)  2.5ULN.\r\n\r\n          -  Adequate renal function: creatinine clearance  60 ml/min or creatinine  1.5ULN.\r\n\r\n          -  Patients must give written informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior malignancy, except adequately treated basal cell or squamous cell skin cancer,\r\n             in situ cervical cancer.\r\n\r\n          -  Pregnancy or lactation (consider pregnancy test in women of child-bearing age and\r\n             emphasize effective contraception during the treatment period).\r\n\r\n          -  History of previous radiotherapy (except for non-melanomatous skin cancers outside\r\n             intended radiotherapy volume).\r\n\r\n          -  Prior radiotherapy, chemotherapy or surgery (except diagnostic) to primary tumor or\r\n             nodes.\r\n\r\n          -  Any severe intercurrent disease, which may bring unacceptable risk or affect the\r\n             compliance of the trial, for example, unstable cardiac disease requiring treatment,\r\n             renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >\r\n             1.5ULN), and emotional disturbance.\r\n      ","sponsor":"Sun Yat-sen University","sponsor_type":"Other","conditions":"Nasopharyngeal Carcinoma","interventions":[{"intervention_type":"Drug","name":"Drug: Cisplatin","description":"Cisplatin 100 mg/m every 3 weeks for 3 cycles during radiotherapy."},{"intervention_type":"Radiation","name":"Radiation: Intensity-modulated radiotherapy","description":"Intensity-modulated radiotherapy"}],"outcomes":[{"outcome_type":"primary","measure":"Overall survival","time_frame":"Two year"},{"outcome_type":"secondary","measure":"failure-free survival","time_frame":"two year"},{"outcome_type":"secondary","measure":"distant metastasis-free survival","time_frame":"two year"},{"outcome_type":"secondary","measure":"locoregional relapse-free survival","time_frame":"two year"},{"outcome_type":"secondary","measure":"Number of participants with treatment-related acute adverse events as assessed by CTCAE v4.0","time_frame":"two months"},{"outcome_type":"secondary","measure":"quality of life assessing by questionnaires","time_frame":"through study completion, an average of 5 year"}]}
{"nct_id":"NCT03229733","start_date":"2015-11-30","phase":"N/A","enrollment":39,"brief_title":"Design and Evaluation the Effects of Kinect-based Computer Games for U/E Training in Chronic Stroke Patients","official_title":"Design and Evaluation the Feasibility, Effects of Kinect-based Computer Games for Rehabilitation Training of Upper Extremity Function in Patients With Chronic Stroke","primary_completion_date":"2017-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-12-31","last_update":"2018-07-18","description":"The aims of this study are to (i) develop exergames by using Kinect system for training UE function in patient with stroke; and (ii) to test the game's feasibility and effects in a group of patient with chronic stroke.","other_id":"CMRPG8E0931","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  First ever ischemic or hemorrhagic stroke or former stroke without any significant\r\n             residual motor impairment\r\n\r\n          -  3 months post stroke\r\n\r\n          -  Impaired arm motor function at Brunnstrom stage 3-5\r\n\r\n          -  Age 18 years or older\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  severe cognitive impairment defined as < 20 on Mini Mental State Examination\r\n\r\n          -  visual disorders or neglect limiting the ability to comply with treatment regimen\r\n\r\n          -  orthopedic problem or other neurological diagnosis that makes the UE dysfunction.\r\n      ","sponsor":"Chang Gung Memorial Hospital","sponsor_type":"Other","conditions":"Stroke","interventions":[{"intervention_type":"Device","name":"Device: Kinect","description":"Receive Kinect games training for 30 minutes. There are 3 sections for 1 week; the intervention period will be 8 weeks"},{"intervention_type":"Behavioral","name":"Behavioral: Traditional occupational therapy","description":"Patients will receive individually tailored conventional training consisting of the similar movement and dose by using the traditional equipment, such as climbing bar."}],"outcomes":[{"outcome_type":"secondary","measure":"The relevant for upper-extremity function self-report questionnaire on Stroke Impact Scale (SIS)","time_frame":"Change from baseline at 5 months","description":"The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment."},{"outcome_type":"secondary","measure":"Standing balance assessed on The Functional reach test (FR)","time_frame":"Change from baseline at 5 months","description":"The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment."},{"outcome_type":"secondary","measure":"Muscle power assessed on Medical Research Council Scale (MRC)","time_frame":"Change from baseline at 5 months","description":"The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment."},{"outcome_type":"secondary","measure":"The instrumental activities of daily living assessed on Nottingham Extended Activities of Daily Living Scale (NEADL)","time_frame":"Change from baseline at 5 months","description":"The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment."},{"outcome_type":"primary","measure":"Motor function assessed on Fugl-Meyer Assessment (FMA)","time_frame":"Change from baseline at 5 months","description":"The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment."},{"outcome_type":"secondary","measure":"The amount of movement assessed on Actigraph Assessment","time_frame":"Change from baseline at 2 months","description":"The outcome will be measured at 2 time points: 0 week, and 8 weeks after recruitment."},{"outcome_type":"secondary","measure":"The upper extremity motor ability assessed on Wolf Motor Function Test (WMFT)","time_frame":"Change from baseline at 5 months","description":"The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment."},{"outcome_type":"secondary","measure":"The quality of movement and amount of use assessed on Motor Activity Log (MAL)","time_frame":"Change from baseline at 5 months","description":"The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment."}]}
{"nct_id":"NCT02589574","start_date":"2015-11-30","phase":"N/A","enrollment":537,"brief_title":"Improving Influenza Vaccination Rates in Nurses Through Text Message Reminders : a RCT","official_title":"Improving Influenza Vaccination Rates in Nurses Through Electronic Text Message Reminders : a Randomised Controlled Trial","primary_completion_date":"2016-08-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2016-08-31","last_update":"2016-07-28","description":"Influenza is an important cause of medical visits and worker absenteeism among healthy adults. Studies of healthcare providers vaccination programmes have reported a positive effect in lowering rates of influenza like illness and influenza related complication, hospitalisation and death. Nurses should receive influenza vaccination so that those patients who may come in contact with will not be infected by their nurses. However, the immunization rate among nurses is constantly low. Therefore, it is important to develop an intervention programmes to increase immunization of nurses. In some research on electronic text messaging in promoting public health showed potential of this communication system in preventive health behavioural change. With the use of this widely acceptable, accessible and convenient approach of communication, reminders of receiving influenza vaccination are sent to nurses involved in this study. At the same time, educational messages are sent to modify their perception on the positive effect of influenza vaccination, and therefore, motivate the nurses to receive the vaccination. The study will be conducted as a two-arm randomised controlled trial which the control and intervention groups will run concurrently. Nurses of a local hospital are invited to participate in this study. They will receive the usual announcement on the information of free influenza vaccination of the hospital. The participants of the intervention group will also receive text message reminders on details for free influenza vaccine and educational information. All communication occurred through secure, asynchronous electronic text messages. The reminders and educational information are developed with reference to promotion messages from the Department of Health under the framework of Health Belief Model so as to promote positive perception on influenza vaccination by the participants. Participants are invited to complete the pre and post questionnaires before and after the study period. The influenza vaccination status of the participants and their perception on influenza vaccination will be obtained. It is hypothesised that the participants receiving the reminders and educational information will more likely to receive influenza vaccine and perceived the influenza vaccination as important measure in protecting them from influenza. The participants of the intervention group will also receptive to electronic text messaging communication and education.","other_id":"UW15-383","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"Single","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. qualified nurses who are employed in the local hospital during the period of study\r\n\r\n          2. owned smart phones with electronic text messaging function\r\n\r\n          3. willing to provide their active mobile telephone numbers\r\n\r\n          4. who have already received influenza vaccination prior to the commencement of the study\r\n             period or those have history of allergy to flu vaccine will be excluded\r\n      ","sponsor":"The University of Hong Kong","sponsor_type":"Other","conditions":"Influenza","interventions":[{"intervention_type":"Other","name":"Other: electronic text message","description":"Besides the reminder of the free vaccination, the messages included information that vaccination reduces the personal risk of influenza illness. It also reduces the risk to infect patients and family members. It is also the social expectation on and professional as well as personal responsibility of nurses in protecting own selves and their patients from contacting influenza.\r\nit is a safe vaccine. The reminders are developed with reference to promotion messages from Hospital Authority."}],"outcomes":[{"outcome_type":"primary","measure":"The receipt of an influenza vaccine dose by Feb 2016 as reported by the participants","time_frame":"up to 5 months"},{"outcome_type":"secondary","measure":"The proportion of participants seeking out influenza vaccination","time_frame":"up to 5 months"},{"outcome_type":"secondary","measure":"The proportion of participants of intervention group receptive to electronic text messaging communication and education","time_frame":"up to 5 months"}]}
{"nct_id":"NCT02619305","start_date":"2015-11-30","phase":"N/A","enrollment":600,"brief_title":"Social Network Outcomes of a Livelihood Intervention for Impoverished Women in Rural Uganda","official_title":"Social Network Outcomes of a Livelihood Intervention for Impoverished Women in Rural Uganda: Randomized Controlled Trial","primary_completion_date":"2017-06-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2017-06-30","last_update":"2015-12-02","description":"The objective of our study is to determine whether a livelihood intervention can change economic and psychosocial outcomes of social network ties and geographically proximate neighbors of impoverished women in rural Uganda.","other_id":"MH096620-S5","allocation":"Randomized","intervention_model":"Parallel Assignment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Eligibility will be limited to all adults living in Nyakabare Parish (i.e., aged 18\r\n             years and older), including emancipated minors. Emancipated minors will be defined as\r\n             persons living below 18 years of age who are married, are pregnant, live with a\r\n             biological child in the household, or are responsible for their own livelihood.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Persons under the age of 18 (other than emancipated minors as described above) and\r\n             persons who do not live within Nyakabare Parish will not be permitted to participate.\r\n      ","sponsor":"Massachusetts General Hospital","sponsor_type":"Other","conditions":"Indigency","interventions":[{"intervention_type":"Other","name":"Other: Social network tie","description":"Participants will be social network ties of women receiving a livelihood intervention package consisting of a orientation and training and a loan package of chickens and associated implements to create poultry microenterprises."}],"outcomes":[{"outcome_type":"primary","measure":"Household Food Insecurity Access Scale","time_frame":"12 months","description":"Scale items range from 0 (never) to 3 (more than 10 days in the past month)"},{"outcome_type":"primary","measure":"Hopkins Symptom Checklist Scale","time_frame":"12 months","description":"Scale items range from 1 (not at all) to 4 (very much)"},{"outcome_type":"secondary","measure":"HIV Stigma Scale","time_frame":"12 months","description":"Agreement (yes/no) with 15 statements about persons living with HIV (range, 0-15), to be assessed among social network ties of HIV-positive study participants"},{"outcome_type":"secondary","measure":"Norms about Intimate Partner Violence Scale","time_frame":"12 months","description":"Agreement (yes/no) with 5 different statements about the acceptability of intimate partner violence under 5 different scenarios (range, 0-5)"},{"outcome_type":"secondary","measure":"Social Integration Scale","time_frame":"12 months","description":"Frequency of participation in 11 different community groups: vocational, positive living, local council, water, village health, agricultural extension, savings, religious, women's, gardening (range, 0-11)"},{"outcome_type":"secondary","measure":"Social Capital Scale","time_frame":"12 months","description":"Agreement (yes/no) with 4 questions about social trust and social cohesion (range, 0-4)"}]}
{"nct_id":"NCT03072407","start_date":"2015-11-24","phase":"Phase 1","enrollment":40,"brief_title":"MAD Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PB-119 to Subjects With T2DM","official_title":"A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Sequential Parallel Group, MAD Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PB-119 to Subjects With T2DM","primary_completion_date":"2016-11-02","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-11-15","last_update":"2018-04-20","description":"This was a phase 1, randomized, double-blind, placebo-controlled, sequential parallel group, MAD study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of four once-weekly subcutaneous doses of PB-119 to subjects with T2DM.","other_id":"CSP-PB119-US01-01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","intervention_model_description":"placebo-control , parallel","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patients in whom T2DM has been diagnosed for at least 3 months prior to screening and\r\n             have not been taking any treatment but have made lifestyle modifications (i.e., diet\r\n             and exercise) for at least 4 weeks or are taking metformin (with no change in the\r\n             treatment including dose over the past 2 months).\r\n\r\n          2. In good general health as determined by the investigator at screening evaluation\r\n\r\n          3. Male and/or female subjects between the ages of 18 and 70 years, inclusive;\r\n\r\n          4. Are capable of giving informed consent and complying with study procedures;\r\n\r\n          5. Body Mass Index (BMI) of approximately 22 to 40 kg/m2;\r\n\r\n          6. Fasting C-peptide test result must be >0.4 nmol/L;\r\n\r\n          7. HbA1c 6.5 % and 12%;\r\n\r\n          8. Female subjects must have a negative urine pregnancy test result prior to enrollment.\r\n\r\n          9. Nonsmoker,\r\n\r\n         10. Willing and able to adhere to study restrictions and to be confined at the clinical\r\n             research center.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Subjects with a personal or family history of medullary thyroid carcinoma (MTC) or in\r\n             subjects with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2);\r\n\r\n          2. Screening fasting blood glucose 100 or 270 mg/dL\r\n\r\n          3. Type 1 diabetes mellitus, or latent autoimmune diabetes in adults; diabetic\r\n             neuropathy, retinopathy or nephropathy;\r\n\r\n          4. Previous treatment with an approved or investigational GLP-1 mimetic;\r\n\r\n          5. Patients treated with any investigational drugs within 6 weeks of screening;\r\n\r\n          6. Subjects with pancreatitis;\r\n\r\n          7. Clinically significant gastrointestinal disorder\r\n\r\n          8. History or symptoms of clinically significant cardiovascular disease, particularly\r\n             coronary artery disease, arrhythmias, atrial tachycardia,\r\n\r\n          9. Uncontrolled hypertension at screening;\r\n\r\n         10. History of clinically significant central nervous system disease including: transient\r\n             ischemic attack, stroke, seizure disorder, depression,\r\n\r\n         11. History of liver disease\r\n\r\n         12. History of clinically significant renal disease\r\n\r\n         13. Uncontrolled severe dyslipidemia;\r\n\r\n         14. Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface\r\n             antigen (HBsAg), or hepatitis C antibody;\r\n\r\n         15. A hospital admission or major surgery within 30 days prior to screening;\r\n\r\n         16. A history of prescription drug abuse, or illicit drug use within 6 months prior to\r\n             screening;\r\n\r\n         17. A history of alcohol abuse according to medical history within 6 months prior to\r\n             screening;\r\n\r\n         18. A positive screen for alcohol, or drugs of abuse;\r\n\r\n         19. An unwillingness or inability to comply with food and beverage restrictions during\r\n             study participation;\r\n\r\n         20. Use of prescription or over-the-counter (OTC) medications, and herbal An\r\n\r\n         21. Unwillingness of male participants to use appropriate contraceptive measures if\r\n             engaging in sexual intercourse with a female partner of childbearing potential.\r\n             Appropriate measures include use of a condom and spermicide and, for female partners,\r\n             use of an intrauterine device (IUD), diaphragm with spermicide, oral contraceptives,\r\n             injectable progesterone, progesterone subdermal implants, or a tubal ligation. Sexual\r\n             intercourse with pregnant or lactating women is prohibited\r\n      ","sponsor":"PegBio Co., Ltd.","sponsor_type":"Other","conditions":"Type2 Diabetes Mellitus","interventions":[{"intervention_type":"Biological","name":"Biological: PB-119 injection"},{"intervention_type":"Biological","name":"Biological: PB-119 injection placebo"}],"outcomes":[{"outcome_type":"primary","measure":"the number of AEs and the finding from the physical examination, the abnormal lab results","time_frame":"accessed up to 4 weeks","description":"include monitoring of AEs, vital signs (blood pressure, pulse rate, respiratory)"},{"outcome_type":"secondary","measure":"PB-119 blood plasma concentration","time_frame":"accessed up to 4 weeks","description":"to collect PB-119 blood plasma concentration of the subjects who use PB-119 intervention"},{"outcome_type":"secondary","measure":"PB-119 antibody","time_frame":"accessed up to 4 weeks","description":"the number of subjects who are with positive antibody results"},{"outcome_type":"secondary","measure":"Insulin sensitivity (SI)","time_frame":"accessed up to 4 weeks","description":"be estimated from glucose and insulin concentration"},{"outcome_type":"secondary","measure":"Beta-cell Responsivity Index","time_frame":"accessed up to 4 weeks","description":"be estimated from serum glucose and c-peptide concentrations"},{"outcome_type":"secondary","measure":"Disposition Index","time_frame":"accessed up to 4 weeks","description":"be calculated for each individual subject as the product of SI and Φtotal"}]}
{"nct_id":"NCT03949699","start_date":"2015-11-24","phase":"N/A","enrollment":11,"brief_title":"Resistance Training to Improve Strength and Functional Trunk Stability in Adults With Paraplegia","official_title":"Resistance Training to Improve Strength and Functional Trunk Stability in Adults With Paraplegia","primary_completion_date":"2019-03-19","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-03-19","last_update":"2019-05-14","description":"The purpose of this study is to examine the effectiveness of an 8- week resistance training routine to improve functional trunk strength, muscle activation, and physical functioning in exercise in 30 adults with paraplegic SCI. This study will also examine outcomes of confidence in one's ability to avoid falling during balance challenges, and self-efficacy for participating in exercise activity.","other_id":"2015P001481","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","intervention_model_description":"pre-post","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria: To be included in the study, all subjects must be adults (>18 years of\r\n        age) and:\r\n\r\n          -  Be in good health (asymptomatic for acute treatable illness)\r\n\r\n          -  Be able to understand, communicate with and be understood by research personnel and\r\n             interpreters\r\n\r\n          -  Be interested in participating and provide informed consent\r\n\r\n          -  Have a SCI with residual deficits (AIS A, B, C), and from the neurological level of T2\r\n             and lower to allow at least partial use of trunk muscles\r\n\r\n          -  Use a wheelchair as primary means of mobility (6 hours/day)\r\n\r\n        Exclusion Criteria: Participants must not be enrolled in any strengthening protocol or\r\n        rehabilitation therapy for strengthening during the time of the study. Participants must\r\n        not have serious comorbidities that could interfere with the ability to participate in an\r\n        exercise program (musculoskeletal, cardiovascular, and neurological [other than SCI]).\r\n        Specifically, participants will be excluded if they have: 1) Musculoskeletal injuries that\r\n        have not healed completely, 2) Had heart surgery or are status post-myocardial infarction\r\n        (MI) in the last 4 to 6 months, 3) Unstable angina, 4) Uncontrolled hypertension (systolic\r\n        blood pressure 160 mm Hg and/or diastolic blood pressure 100 mm Hg), 5) uncontrolled\r\n        dysrhythmias, 6) Recent history of congestive heart failure that has not been evaluated and\r\n        effectively treated, 7) Severe stenotic or regurgitant valvular disease, or 8) Hypertrophic\r\n        cardiomyopathy.\r\n\r\n        -\r\n      ","sponsor":"Spaulding Rehabilitation Hospital","sponsor_type":"Other","conditions":"Spinal Cord Injuries","interventions":[{"intervention_type":"Other","name":"Other: Resistance training","description":"Participants will engage in strengthening exercises using a cable tower while seated. These movements will include trunk flexion and extension, diagonal trunk rotation, and lateral trunk flexion. The goal for resistance training frequency (Weeks 1-8) will be three times per week, lasting about 30-45 minutes per session including warm-up/cool-down, for a duration of eight weeks. Resistance intensity of each exercise will also be determined based on the initial maximal strength performing that exercise: Weeks 1-4 will be 50-60% of the baseline calculated 1 repetition maximum (RM) values; Weeks 5-8 will use resistive loads equivalent to 50-60% of Week 4 1RM calculations"}],"outcomes":[{"outcome_type":"primary","measure":"Change in Strength","time_frame":". Testing will be repeated at weeks 4 & 8. Maximum strength values established during Baseline and 4th week testing will be used to calculate the exercise workloads for the next four weeks of training","description":"Maximum strength: Subjects will be given a set of ten repetitions with a light weight, as a warm-up prior to testing. The weight stack will then be adjusted to a load intended to induce muscular fatigue within ten repetitions. The subject will perform as many complete repetitions as possible. Once the subject fails to perform a repetition through the complete range of motion, they will have reached fatigue, and the weight and number of repetitions will be recorded. If the number of repetitions exceeds ten, then the weight will be increased and the subject will be given a three-minute rest interval before repeating the test. A regression equation 4 will then be used to calculate maximum strength"},{"outcome_type":"primary","measure":"Change in Balance","time_frame":"Baseline, and weeks 4 & 8","description":"Items from the Activity-based Balance Level Evaluation (ABLE) Sitting Balance subscale: Participants perform the following activities, which are scored according to ability and quality of movement: 1.Sitting with back unsupported but feet supported on floor or on a foot stool; 2. Modified functional reach test; 3. Seated lateral reach; 4. Pick up an object from the floor from a seated position; 5. Scooting forward in a chair; and 6. External perturbations in sitting. This measure typically takes 15 minutes to administer."},{"outcome_type":"secondary","measure":"Change in SCI-Functional Index (SCI-FI)","time_frame":"Baseline and 8 weeks","description":"A self-report computer-adapted test measuring difficulty performing activities in the domains of Basic Mobility, Self-Care, and Wheelchair Mobility. This measure typically takes less than 7 minutes to administer"},{"outcome_type":"secondary","measure":"Change in Falls Concern Scale for people with SCI (SCI-FCS)","time_frame":"Baseline and 8 weeks","description":"A questionnaire that asks respondents to rate their level of concern about the possibility of falling during 16 daily activities. Ratings are given on a 4-point Likert scale from Not at all concerned (1) to very concerned (4). This measure typically takes 5 minutes or less to complete."},{"outcome_type":"secondary","measure":"Change in SCI Exercise Self-Efficacy Scale (SCI ESES)","time_frame":"Baseline and 8 weeks","description":"Participants respond to 10 items on a 4-point Likert-style scale (1-not at all true, 4-always true) that is used to determine likelihood of the respondent to engage in exercise activity. This measure typically takes less than 5 minutes to administer."}]}
{"nct_id":"NCT02848612","start_date":"2015-11-20","enrollment":459,"brief_title":"Evaluation of the Amiens University Hospital Neuroradiology Anticoagulation Protocol","official_title":"Evaluation of the Amiens University Hospital Neuroradiology Anticoagulation Protocol","primary_completion_date":"2016-07-15","study_type":"Observational","rec_status":"Completed","completion_date":"2016-07-15","last_update":"2018-10-12","description":"To prevent thromboembolic complications, the embolization procedure is performed under prophylactic unfractionated heparin, the efficacy of which is monitored by point-of- care testing according to international guidelines. However, these guidelines are based on limited scientific evidence and the ideal level of anticoagulation required has not been precisely defined. Furthermore, the correlation between the point-of- care tests used at Amiens University Hospital and the reference methods used in the laboratory varies considerably according to the available literature.","other_id":"RNI2015-13 Pr Lorne","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients over the age of 18 years undergoing one of the following interventional\r\n        neuroradiology procedures at Amiens University Hospital: elective embolization of an\r\n        intracranial aneurysm, emergency embolization of a ruptured intracranial aneurysm, elective\r\n        or urgent embolization of an intracranial or perispinal arteriovenous malformation.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients over the age of 18 years undergoing one of the following interventional\r\n             neuroradiology procedures at Amiens University Hospital: elective embolization of an\r\n             intracranial aneurysm, emergency embolization of a ruptured intracranial aneurysm,\r\n             elective or urgent embolization of an intracranial or perispinal arteriovenous\r\n             malformation.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients in whom all modalities of monitoring of the efficacy of anticoagulation\r\n             (laboratory tests and point-of-care tests) were not performed, incomplete embolization\r\n             or radiological follow-up records.\r\n\r\n          -  Patients presenting a contraindication to the administration of unfractionated\r\n             heparin: history of heparin-induced thrombocytopenia or haemorrhagic coagulopathy (von\r\n             Willebrand disease, haemophilia).\r\n      ","sponsor":"Centre Hospitalier Universitaire, Amiens","sponsor_type":"Other","conditions":"Aneurysm","interventions":[{"intervention_type":"Drug","name":"Drug: anticoagulation by unfractionated heparin","description":"anticoagulation by unfractionated heparin"}],"outcomes":[{"outcome_type":"primary","measure":"correlation between laboratory clotting tests and point-of-care clotting tests","time_frame":"6 months","description":"evaluation of the correlation between laboratory clotting tests and point-of-care clotting tests performed on the Hemochron Junior® device.\r\ncare clotting tests and laboratory tests in the setting of intracranial\r\nembolization."}]}
{"nct_id":"NCT03515473","start_date":"2015-11-13","enrollment":139,"brief_title":"Subjective and Objective Results With CI Electrode Types","official_title":"Subjective and Objective Results With CI Electrode Types","primary_completion_date":"2017-06-04","study_type":"Observational","rec_status":"Completed","completion_date":"2017-11-30","last_update":"2018-05-03","description":"Background The authors' aim was to compare the influence of various electrode designs on selected objective and subjective clinical outcomes for cochlear implant recipients using the same model of receiver-stimulator, Cochlear Nucleus Profile Series and sound processor. Methods A multicenter study with subjects with profound sensorineural hearing loss, who were implanted and followed up in two tertiary centers. A total of 54 ears were implanted with Cochlear Nucleus CI532, 51 with Cochlear Nucleus CI522 and 54 with the Cochlear Nucleus CI512. Implant loss and intraoperative electrophysiological tests (electrically evoked stapedial reflex threshold [ESRT], neural response telemetry threshold [T-NRT] and impedance), postoperative data (C-level, T-level, dynamic range, T-NRT and power consumption) and intracochlear position of the active electrode were analyzed with Nucleus Custom Sound 4.4 software.","other_id":"CI-001","observational_model":"Case-Control","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","population":"Subjects implanted with CI532 or CI512 or CI522 in Szeged and St. Plten between the\r\n        indicated time frames","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  successful cochlear implantation with CI532 or CI512 or CI522\r\n\r\n          -  gave informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  unsuccessful cochlear implantation\r\n      ","sponsor":"Szeged University","sponsor_type":"Other","conditions":"Cochlear Implant","interventions":[{"intervention_type":"Device","name":"Device: cochlear implant","description":"cochlear implant surgery"}],"outcomes":[{"outcome_type":"primary","measure":"Intraoperative measurements","time_frame":"1 day","description":"Intraoperative impedance (kOhm) of the stimulating electrode with different types of cochlear implants."},{"outcome_type":"primary","measure":"Intraoperative measurements","time_frame":"1 day","description":"Electrical stapedial reflex threshold (ESRT; current unit) with different types of cochlear implants"},{"outcome_type":"primary","measure":"Intraoperative measurements","time_frame":"1 day","description":"Neural response telemetry threshold (T-NRT; current unit) with different types of cochlear implants"},{"outcome_type":"secondary","measure":"Postoperative measurements","time_frame":"3 months","description":"Postoperative neural response telemetry threshold (T-NRT; current unit) with different types of cochlear implants"},{"outcome_type":"secondary","measure":"Postoperative measurements","time_frame":"3 months","description":"Postoperative comfort level (C-level; current unit) with different types of cochlear implants"},{"outcome_type":"secondary","measure":"Postoperative measurements","time_frame":"3 months","description":"Power consumption of different types of cochlear implants"}]}
{"nct_id":"NCT02506933","start_date":"2015-11-05","phase":"Phase 2","enrollment":102,"brief_title":"Multi-antigen CMV-MVA Triplex Vaccine in Reducing CMV Complications in Patients Previously Infected With CMV and Undergoing Donor Hematopoietic Cell Transplant","official_title":"A Phase II Randomized, Placebo-Controlled, Multicenter Trial to Evaluate the Protective Function of a CMV-MVA Triplex Vaccine in Recipients of an Allogeneic Hematopoietic Stem Cell Transplant","primary_completion_date":"2021-12-14","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2021-12-14","last_update":"2021-01-27","description":"This randomized phase II trial studies the safety and how well multi-peptide cytomegalovirus (CMV)-modified vaccinia Ankara (MVA) vaccine works in reducing CMV complications in patients previously infected with CMV and are undergoing a donor hematopoietic cell transplant. CMV is a virus that may reproduce and cause disease and even death in patients with lowered immune systems, such as those undergoing a hematopoietic cell transplant. By placing 3 small pieces of CMV deoxyribonucleic acid (DNA) (the chemical form of genes) into a very safe, weakened virus called MVA, the multi-peptide CMV-MVA vaccine may be able to induce immunity (the ability to recognize and respond to an infection) to CMV. This may help to reduce both CMV complications and reduce the need for antiviral drugs in patients undergoing a donor hematopoietic cell transplant.","other_id":"14295","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  All subjects must have the ability to understand and the willingness to sign a written\r\n             informed consent\r\n\r\n          -  Participant must be willing to comply with study and/or follow-up procedures,\r\n             including willingness to be followed for one year post-HCT\r\n\r\n          -  Planned HCT for the treatment of the following hematologic malignancies:\r\n\r\n               -  Lymphoma (Hodgkin and Non-Hodgkin)\r\n\r\n               -  Myelodysplastic syndrome\r\n\r\n               -  Acute lymphoblastic leukemia in first or second remission (for acute\r\n                  lymphoblastic leukemia/lymphoblastic lymphoma, the disease status must be in\r\n                  hematologic remission by bone marrow and peripheral blood; persistent\r\n                  lymphadenopathy on computed tomography [CT] or CT/positron emission tomography\r\n                  (PET) scan without progression is allowed)\r\n\r\n               -  Acute myeloid leukemia in first or second remission\r\n\r\n               -  Chronic myelogenous leukemia in first chronic or accelerated phase, or in second\r\n                  chronic phase\r\n\r\n               -  Other hematologic malignancies including chronic lymphocytic leukemia,\r\n                  myeloproliferative disorders and myelofibrosis; patients with multiple myeloma\r\n                  and those with non-malignant disease such as aplastic anemia are excluded\r\n\r\n               -  Patients undergoing a second allogeneic (allo) HCT are not eligible (patients who\r\n                  have undergone a previous autologous HCT are eligible)\r\n\r\n          -  CMV seropositive (recipient)\r\n\r\n          -  Planned related or unrelated HCT, with 8/8 (A,B,C,DRB1) high/intermediate resolution\r\n             HLA donor allele matching\r\n\r\n          -  Planned HCT with minimal to no-T cell depletion of graft\r\n\r\n          -  Conditioning and immunosuppressive regimens according to institutional guidelines are\r\n             permitted\r\n\r\n          -  Negative serum or urine beta-human chorionic gonadotropin (HCG) test (female patient\r\n             of childbearing potential only) within two weeks of registration\r\n\r\n          -  Seronegative for human immunodeficiency virus (HIV), hepatitis C virus (HCV) and\r\n             active hepatitis B virus (HBV) (surface antigen negative) within 2 months of\r\n             registration\r\n\r\n          -  Agreement by females of childbearing potential and sexually active males to use an\r\n             effective method of contraception (hormonal or barrier method of birth control or\r\n             abstinence) prior to study entry and for up to 90 days post-HCT; should a woman become\r\n             pregnant or suspect that she is pregnant while participating on the trial, she should\r\n             inform her treating physician immediately\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any prior investigational CMV vaccine\r\n\r\n          -  Experimental anti-CMV chemotherapy in the last 6 months\r\n\r\n          -  Live attenuated vaccines\r\n\r\n          -  Medically indicated subunit (Engerix-B for HBV; Gardasil for human papillomavirus\r\n             [HPV]) or killed vaccines (e.g. influenza, pneumococcal, or allergy treatment with\r\n             antigen injections)\r\n\r\n          -  Allergy treatment with antigens injections\r\n\r\n          -  Alemtuzumab or any equivalent in vivo T-cell depleting agent\r\n\r\n          -  Antiviral medications with known therapeutic effects on CMV such as ganciclovir\r\n             (GCV)/valganciclovir (VAL), foscarnet (FOS), Cidofovir, CMX-001, maribavir; acyclovir\r\n             has no known therapeutic efficacy against CMV and is allowable as standard of care to\r\n             prevent herpes simplex virus (HSV)\r\n\r\n          -  Prophylactic therapy with CMV immunoglobulin or prophylactic antiviral CMV treatment\r\n\r\n          -  Other investigational product - concurrent enrollment in other clinical trials using\r\n             any investigational new drug (IND) drugs with unknown effects on CMV or with unknown\r\n             toxicity profiles is prohibited\r\n\r\n          -  Other medications that might interfere with the evaluation of the investigational\r\n             product\r\n\r\n          -  Patients with active autoimmune conditions requiring systemic immunosuppressive\r\n             therapy within the previous 5 years are not eligible\r\n\r\n          -  Pregnant women and women who are lactating; breastfeeding should be discontinued if\r\n             the mother is enrolled on this study\r\n\r\n          -  Any other condition that would, in the Investigator's judgment, contraindicate the\r\n             patient's participation in the clinical study due to safety concerns or compliance\r\n             with clinical study procedures, e.g., social/ psychological issues, etc\r\n\r\n          -  Prospective participants who, in the opinion of the investigator, may not be able to\r\n             comply with all study procedures (including compliance issues related to\r\n             feasibility/logistics)\r\n      ","sponsor":"City of Hope Medical Center","sponsor_type":"Other","conditions":"Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive|Acute Lymphoblastic Leukemia in Remission|Acute Myeloid Leukemia in Remission|Chronic Lymphocytic Leukemia|Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive|Cytomegaloviral Infection|Hodgkin Lymphoma|Lymphadenopathy|Lymphoblastic Lymphoma|Myelodysplastic Syndrome|Myelofibrosis|Myeloproliferative Neoplasm|Non-Hodgkin Lymphoma","interventions":[{"intervention_type":"Other","name":"Other: Laboratory Biomarker Analysis","description":"Correlative studies"},{"intervention_type":"Biological","name":"Biological: Multi-peptide CMV-Modified Vaccinia Ankara Vaccine","description":"Given IM"},{"intervention_type":"Other","name":"Other: Placebo","description":"Given IM"}],"outcomes":[{"outcome_type":"secondary","measure":"Duration of viremia","time_frame":"Up to 1 year post-HCT","description":"The total days on antivirals for CMV reactivation (induction, maintenance, and total) will be assessed for each individual, with arms compared using Wilcoxon's rank-sum test. Other characterizations of the duration of viremia and response to therapy will be descriptive in nature."},{"outcome_type":"primary","measure":"CMV events encompassing any CMV reactivation >= 500 CMV genome copies gc/mL, low-level reactivation prompting antiviral therapy, or CMV disease","time_frame":"Prior to day 100 post-HCT","description":"Vaccine and placebo groups will be compared with regard to the hazard of CMV events, using the Anderson-Gill approach to repeated events, as implemented in the R survival package. Power calculations are conservatively based only on binomial incident event rates."},{"outcome_type":"primary","measure":"Incidence of grade 3-4 severe adverse events (SAE) that are at least possibly attributed to the injection by the (masked) treating physician, assessed by CTCAE version 4.0","time_frame":"Within 2 weeks of injection","description":"Will be listed, with incidence compared by Fisher's exact test."},{"outcome_type":"primary","measure":"Incidence of severe (grade 3-4) aGVHD","time_frame":"Up to 100 days post-HCT","description":"Will be summarized by Kaplan-Meier curves, and compared using the log-rank test."},{"outcome_type":"primary","measure":"NRM","time_frame":"At 100 days post-HCT","description":"Will be summarized by arm as percentages, with exact binomial confidence bounds, and compared across arms using Fishers exact test."},{"outcome_type":"secondary","measure":"All-cause mortality","time_frame":"Up to 1 year post-HCT"},{"outcome_type":"secondary","measure":"Cumulative number of CMV specific antiviral treatment days","time_frame":"Up to 1 year post-HCT"},{"outcome_type":"secondary","measure":"Incidence of aGVHD","time_frame":"Up to 1 year post-HCT","description":"The cumulative incidence of aGVHD will be estimated using Kaplan-Meier or Fine-Gray estimators, as appropriate, and compared using the log-rank test, or the corresponding subdistribution test due to Gray."},{"outcome_type":"secondary","measure":"Incidence of cGVHD","time_frame":"Up to 1 year post-HCT","description":"The cumulative incidence of cGVHD will be estimated using Kaplan-Meier or Fine-Gray estimators, as appropriate, and compared using the log-rank test, or the corresponding subdistribution test due to Gray."},{"outcome_type":"secondary","measure":"Incidence of infections","time_frame":"Up to 1 year post-HCT"},{"outcome_type":"secondary","measure":"Incidence of late CMV viremia","time_frame":"Up to 360 days post-HCT","description":"Assessed between > 100 days and =< 360 days post-HCT."},{"outcome_type":"secondary","measure":"Levels and kinetics of CMV-specific T cell immunity","time_frame":"Up to 1 year post-HCT","description":"Will be combined with immunophenotyping and functional studies. The data analysis for estimating the effect of vaccination on cellular immunity will necessarily be more exploratory in nature. The longitudinal CMV-specific cellular assay data will be modeled on a logarithmic scale, using a generalized estimating equation approach to accommodate the stochastic dependence through time. This produces an estimated multiplicative effect of vaccination, qualified by a valid estimate of variability."},{"outcome_type":"secondary","measure":"NK phenotype and function (cytotoxicity and cytokine production)","time_frame":"Up to 1 year post-HCT","description":"The data analysis for estimating the effect of vaccination on cellular immunity will necessarily be more exploratory in nature. The longitudinal CMV-specific cellular assay data will be modeled on a logarithmic scale, using a generalized estimating equation approach to accommodate the stochastic dependence through time. This produces an estimated multiplicative effect of vaccination, qualified by a valid estimate of variability."},{"outcome_type":"secondary","measure":"NRM","time_frame":"Up to 1 year post-HCT"},{"outcome_type":"secondary","measure":"Relapse-free survival","time_frame":"Up to 1 year post-HCT","description":"The cumulative incidence of relapse-free survival will be estimated using Kaplan-Meier or Fine-Gray estimators, as appropriate, and compared using the log-rank test, or the corresponding subdistribution test due to Gray."},{"outcome_type":"secondary","measure":"Time to engraftment, defined as the first of 3 consecutive days when the peripheral blood absolute neutrophil count is >= 500/mm^3","time_frame":"Up to 1 year post-HCT"},{"outcome_type":"secondary","measure":"Time-to viremia, defined as number of days from transplantation to the date of > 500 CMV gc/mL","time_frame":"Up to 1 year post-HCT"},{"outcome_type":"secondary","measure":"Use of antiviral drugs, triggered by clinically significant viremia >= 1500 CMV gc/mL","time_frame":"Up to 1 year post-HCT"}]}
{"nct_id":"NCT02515331","start_date":"2015-11-04","phase":"Phase 2","enrollment":64,"brief_title":"Safety and Efficacy Study of LHW090 in Resistant Hypertension Patients","official_title":"A Randomized, Sponsor Open, Site and Subject Double Blind, Parallel Group, Placebo-controlled Study to Evaluate the Safety and Efficacy of LHW090 After 4 Weeks Treatment in Patients With Resistant Hypertension","primary_completion_date":"2017-08-17","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-08-17","last_update":"2021-01-05","description":"The purpose of the present study was to determine whether LHW090 displays the clinical safety and efficacy profile to support further development in patients with resistant hypertension.","other_id":"CLHW090X2202","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":40,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male and female patients, age 40 to 85 years inclusive.\r\n\r\n          -   Patients with uncontrolled hypertension (here defined as having a mean daytime\r\n             systolic BP  135 mmHg by ABPM at screening) despite treatment with a stable (at least\r\n             1 month) regimen that includes an optimal dose of an ARB plus a diuretic plus at least\r\n             one additional class of anti-hypertensive medication.\r\n\r\n        For the purposes of this trial, optimal doses of anti-hypertensive medications are defined\r\n        as:\r\n\r\n          -  the highest dose listed in the clinical practice guideline from the American Society\r\n             for Hypertension and the International Society for Hypertension or\r\n\r\n          -  the highest allowable prescribed dose per the manufacturer's label or\r\n\r\n          -  the highest dose tolerated by an individual patient or\r\n\r\n          -  the highest dose appropriate for an individual patient in the judgment of the\r\n             Investigator\r\n\r\n          -  Subjects must weigh at least 45 kg to participate in the study and must have a body\r\n             mass index (BMI) within the range of 18-38 kg/m^2.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with an estimated GFR <60 ml/min/1.73m^2.\r\n\r\n          -  Use of angiotensin converting enzyme inhibitors (ACE-inhibitors). Note: Patients who\r\n             discontinue their ACE-inhibitor and substitute with an angiotensin receptor blocker\r\n             may be eligible to be re-screened provided their anti-hypertensive regimen has been\r\n             stable for at least 1 month. Any substitutions or changes to a patient's\r\n             anti-hypertensive regimen should be done under the guidance of the patient's treating\r\n             physician.\r\n\r\n          -  Severe hypertension as defined by systolic blood pressure 180 mmHg or diastolic blood\r\n             pressure 110 mmHg at screening.\r\n\r\n          -  A history of secondary hypertension of any etiology including but not limited to\r\n             unilateral or bilateral renal artery stenosis, polycystic kidney disease, coarctation\r\n             of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, and\r\n             drug-induced hypertension.\r\n\r\n          -  Known current significant left ventricular outflow obstruction, such as obstructive\r\n             hypertrophic cardiomyopathy or significant severe valvular disease on prior or current\r\n             echocardiogram).\r\n\r\n          -  A history of known moderate or malignant retinopathy defined as moderate (retinal\r\n             signs of hemorrhage), microaneurysms, cotton-wool spots, hard exudates, or a\r\n             combination thereof) or malignant (signs of moderate retinopathy plus swelling of the\r\n             optic disk). Patients with a stable ophthalmologic history in the past 6 months are\r\n             eligible.\r\n\r\n          -  To facilitate ABPM assessment, an upper arm circumference greater than 42 cm.\r\n\r\n          -  History within the previous 6 months of myocardial infarction, coronary artery bypass\r\n             graft (CABG), percutaneous coronary intervention (PCI), hypertensive encephalopathy,\r\n             stroke, or transient ischemic attack (TIA).\r\n\r\n        Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female\r\n        after conception and until the termination of gestation, confirmed by a positive hCG\r\n        laboratory test.\r\n\r\n         Women of child-bearing potential\r\n      ","sponsor":"Novartis Pharmaceuticals","sponsor_type":"Industry","conditions":"Patients, Resistant Hypertension","interventions":[{"intervention_type":"Drug","name":"Drug: LHW090","description":"Capsule - oral dose"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Capsule - oral dose"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants With Reported Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths","time_frame":"6 months","description":"Number of participants with AEs, SAEs and deaths were assessed."},{"outcome_type":"primary","measure":"Change From Baseline in Mean Daytime Blood Pressure","time_frame":"Baseline, day 27","description":"Change in the 12 hour average of systolic blood pressure (SBP) measured by ambulatory blood pressure was defined as the 12 hour daytime average SBP on Day 28 minus the 12 hour daytime average SBP on Day -1. monitoring (ABPM). A negative change from baseline indicates improvement."},{"outcome_type":"secondary","measure":"Pharmacokinetics of LHW090/LHV527 in Plasma: Observe Maximum Plasma Concentration Following LHW090 at Steady State in Patients (Cmax)","time_frame":"Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28","description":"Blood samples were collected to assess Cmax."},{"outcome_type":"secondary","measure":"Pharmacokinetics of LHW090/LHV527 in Plasma: Time to Reach the Maximum Concentration After Administration of LHW090 (Tmax)","time_frame":"Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28","description":"Blood samples were collected to assess Tmax."},{"outcome_type":"secondary","measure":"Pharmacokinetics of LHW090/LHV527 in Plasma: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast)","time_frame":"Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28","description":"Blood samples were collected to assess AUClast."},{"outcome_type":"secondary","measure":"Pharmacokinetics of LHW090/LHV527 in Plasma: Last Measurable Plasma Concentration (Clast)","time_frame":"Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28","description":"Blood samples were collected to assess Clast."},{"outcome_type":"secondary","measure":"Pharmacokinetics of LHW090/LHV527 in Plasma:Tlast","time_frame":"Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28","description":"Blood samples were collected to assess Tlast."}]}
{"nct_id":"NCT04594044","start_date":"2015-11-01","phase":"N/A","enrollment":59,"brief_title":"Group Therapy Versus Individual Therapy for Tourette Syndrome and Chronic Tic Disorder","official_title":"Group Therapy Versus Individual Therapy in Children and Adolescents With Tourette Syndrome and Chronic Tic Disorder","primary_completion_date":"2017-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-12-31","last_update":"2021-07-21","description":"Chronic tic disorder (CTD) may have a huge impact on life quality. Habit Reversal Training (HRT) and Exposure Response Prevention (ERP) are effective therapeutic modalities. This study examined the effect of a combined treatment using both HRT and ERP in children and adolescents with CTD. The treatment outcome was examined as an individual treatment compared to a group setting. There was no control group. The study examined both acute outcome and outcome at one year of follow-up. Predictive factors for treatment outcome were evaluated.","other_id":"1-10-72-216-15","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","intervention_model_description":"In an open randomized controlled study, youth were randomized to either individualized, or group treatment. Both therapies included nine sessions, and the parents were offered one group-session. Treatment effect was evaluated after 8 and 9 months, and after one year of follow-up","sampling_method":"","gender":"All","minimum_age":9,"maximum_age":17,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  A primary diagnosis of either Tourette syndrome or a chronic motor/vocal tics disorder\r\n\r\n          -  Moderate or greater severity corresponding to a total score on the Yale Global Tic\r\n             Severity Scale (YGTSS) higher than 13 (higher than nine if only motor or vocal tics\r\n             were described)\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Disorders that required immediate treatment\r\n\r\n               -  psychotic disorder\r\n\r\n               -  primary severe depression\r\n\r\n               -  suicidal ideation or attempts\r\n\r\n               -  primary severe anorexia nervosa\r\n\r\n          2. Disorders that makes participation difficult\r\n\r\n               -  IQ below 70\r\n\r\n               -  a life-time diagnosis of pervasive developmental disorder\r\n\r\n          3. Treatment with HRT or ERP during the last six months.\r\n      ","sponsor":"Aarhus University Hospital","sponsor_type":"Other","conditions":"Chronic Tic Disorder","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: tics training including habit reversal training and exposure response prevention","description":"In an open randomized controlled study, youth were randomized to either individualized, or group treatment. Both therapies included nine sessions, and the parents were offered one group-session."}],"outcomes":[{"outcome_type":"primary","measure":"Change of baseline Yale Global Tic Severity Scale (YGTSS) at 16 weeks, 24 weeks, 40 weeks and 68 weeks","time_frame":"Baseline,16 weeks, 24 weeks, 40 weeks, 68 weeks","description":"Measures the change in Total tic score and functional impairment at different end points on the Yale Global Tic Severity Scale (unabbreviated scale title). Interval 0-100, high score means a worse outcome"},{"outcome_type":"secondary","measure":"Change of baseline Premonitory urge (PUTS) at 6 weeks, 16 weeks, 24 weeks, and 68 weeks","time_frame":"Baseline, 6 weeks, 16 weeks, 24 weeks, 68 weeks","description":"Measures the change of baseline premonitory urge score at different end points on the Premonitory Urge scale (unabbreviated scale title). Interval 1-4, high score means a worse outcome"},{"outcome_type":"secondary","measure":"Change of baseline Beliefs About Tics Scale (BATS) at 6 weeks, 16 weeks, 24 weeks, and 68 weeks","time_frame":"Baseline, 6 weeks, 16 weeks, 24 weeks, 68 weeks","description":"Measures the change of baseline Beliefs About Tics Scale score at different end points on the Beliefs About Tics Scale (unabbreviated scale title). Interval 1-4, high score means a worse outcome"}]}
{"nct_id":"NCT02594306","start_date":"2015-10-31","phase":"N/A","enrollment":20,"brief_title":"Brain Electrophysiological Study(EEG/ERP) on Opiate Addicts Treating by Bilateral NAc/ALIC Deep Brain Stimulation","official_title":"Brain Electrophysiological Study(EEG/ERP) on Opiate Addicts Treating by Bilateral NAc/ALIC Deep Brain Stimulation","primary_completion_date":"2016-11-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2016-11-30","last_update":"2016-02-19","description":"Drug addiction is compulsive and spontaneous drug-taking behavior which is characterized by non-medical usage, long and repeated exposure to addictive drugs and gradually increasing drug-taking dosage and frequency,and become a main threat against human being's public health, economic development and social safety.","other_id":"EEG/ERP and drug addiction","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age between 18 and 65 years of age, male or female\r\n\r\n          2. Opiate addictive over 3 years\r\n\r\n          3. Physical detoxification completedkeep abstinent for at least 7 daysacute abstinent\r\n             syndrome disappearedmorphine urinalysis and naloxone test showed negative)\r\n\r\n          4. No obvious neuropsychiatry and personality disorders\r\n\r\n          5. No severe infectious disease\r\n\r\n          6. Good compliance and be able to complete follow up\r\n\r\n          7. General health is goodno severe liverkidneyheart and lung disease\r\n\r\n          8. Informed consent issued\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Severe cognitive disordersMMSE scale: illiteracy17primary school20secondary\r\n             school or above24,bad compliance because of dementia,unable to issue the informed\r\n             content\r\n\r\n          2. History of severe neuropsychiatric disease\r\n\r\n          3. Epilepsy\r\n\r\n          4. severe liverkidneyheart and lung disease, severe hypertension and severe orthostatic\r\n             hypotension\r\n\r\n          5. Malignant tumorHistory of brain traumaPregnant female\r\n\r\n          6. Patients are taking part in other clinical trials in recent 3 months\r\n\r\n          7. Being deem as unfit for the trials by researcher.\r\n      ","sponsor":"Tang-Du Hospital","sponsor_type":"Other","conditions":"Substance-Related Disorders","interventions":[{"intervention_type":"Device","name":"Device: Emotional pictures stimulation system","description":"Emotional pictures stimulation system is component of neutral and drug-related images."},{"intervention_type":"Procedure","name":"Procedure: Deep brain stimulation","description":"Deep brain stimulation of bilateral NAc/ALIC"},{"intervention_type":"Procedure","name":"Procedure: adjacent contact stimulation","description":"The electrode of deep brain stimulation has four contacts.We stimulate one contact,and record the local field potential of other contacts."},{"intervention_type":"Procedure","name":"Procedure: microelectrode","description":"We put the microelectrodes into bilateral nucleus accumbens and anterior limb of the internal capsule,to record the waveform of bilateral NAc/ALIC."}],"outcomes":[{"outcome_type":"secondary","measure":"Opiate Addiction Severity Inventory(OASI)","time_frame":"day 3"},{"outcome_type":"secondary","measure":"the 13-item obsessive compulsive drug use scale(OCDUS)","time_frame":"day 3"},{"outcome_type":"primary","measure":"Event related potentials(ERPs)","time_frame":"Day 3","description":"Event related potentials include late positive potential（LPP),P300,mismatch negativity(MMN) and N400.Recording the event related potential when people receive the stimulus of emotional pictures stimulation system."},{"outcome_type":"secondary","measure":"local field potential(LFP)","time_frame":"in surgery,3 days after surgery","description":"Recording the LFP of DBS group without any stimulation and stimulate one contact in surgery and 3 days after surgery."},{"outcome_type":"secondary","measure":"participants' craving for opioid drugs (VAS)","time_frame":"day 3","description":"The 10-point visual analog scale(VAS)will be utilized at day 3."},{"outcome_type":"secondary","measure":"The Symptom Checklist-90(SCL-90)","time_frame":"day 3","description":"The Symptom Checklist-90(SCL-90) is used to evaluate general status."},{"outcome_type":"secondary","measure":"Self-Rating Depression Scale(SDS)","time_frame":"day 3","description":"Self-Rating Depression Scale(SDS) is used to evaluate depression symptom."},{"outcome_type":"secondary","measure":"Yale-Brown Obsessive Compulsive Scale(Y-BOCS)","time_frame":"day 3","description":"Yale-Brown Obsessive Compulsive Scale(Y-BOCS) is used to evaluate obsessive compulsive symptom."},{"outcome_type":"secondary","measure":"The Eysenck Personality Questionnaire(EPQ)","time_frame":"day 3"},{"outcome_type":"secondary","measure":"The Wechsler Memory Scale(WMS)","time_frame":"day 3"}]}
{"nct_id":"NCT02571400","start_date":"2015-10-31","enrollment":1013,"brief_title":"Prevalence and Predictors of Prolonged Post-surgical Opioid Use: a Prospective Observational Cohort Study","official_title":"Prevalence and Predictors of Prolonged Post-surgical Opioid Use: a Prospective Observational Cohort Study","primary_completion_date":"2016-10-31","study_type":"Observational","rec_status":"Completed","completion_date":"2016-10-31","last_update":"2017-05-10","description":"Post-surgical opioid prescribing intended for the short-term management of acute pain may lead to long-term opioid use, and its associated harms. This study was undertaken to determine the prevalence of prolonged post-surgical opioid use, and patient-related factors associated with prolonged post-surgical opioid use.","other_id":"UNDAustralia","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Pre-Admission Clinic, St Vincent's Private Hospital (pre-operative assessment unit) Day\r\n        Surgery Unit, St Vincent's Private Hospital","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age 18 years\r\n\r\n          -  Able to give written informed consent\r\n\r\n          -  Willing to participate and comply with the study\r\n\r\n          -  Scheduled to undergo surgery at St Vincent's Private Hospital, and attending the\r\n             pre-admission clinic or day surgery unit\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Opioid tolerant patients (patients who are chronically receiving opioid analgesics on\r\n             a daily basis)\r\n\r\n          -  Scheduled to undergo surgery relating to malignancy\r\n\r\n          -  Surgical procedures completed under local anaesthetic\r\n\r\n          -  Minimally invasive procedures including gastroscopy, colonoscopy, bronchoscopy,\r\n             cardioversion or transoesophageal echo\r\n\r\n          -  Patients who were unable to complete study questionnaires due to psychological\r\n             illness, medical condition or significant language barrier were excluded from the\r\n             study.\r\n      ","sponsor":"University of Notre Dame Australia","sponsor_type":"Other","conditions":"Opioid Use Disorders|Opioid-related Disorders|Surgery|Pain, Postoperative|Post-operative Complications|Opiate Addiction","interventions":[{"intervention_type":"Other","name":"Other: Continued use of opioid analgesics >90 days post-surgery","description":"Exposure of interest: continued use of opioid analgesics >90 days post-surgery"}],"outcomes":[{"outcome_type":"primary","measure":"Continued opioid use","time_frame":"90 days post-surgery","description":"Subjects will be recruited to the study from October 2015 to March 2016, prior to their elective surgical procedure. All subjects will be contacted by investigators at 90 days post-surgery. At this point, they will be asked questions regarding their current analgesic use. This will enable us to calculate the prevalence of continued opioid use at ≥90 days post-surgery. Data collection will be complete by June 2016."},{"outcome_type":"secondary","measure":"Pain scores (score/10)","time_frame":"90 days post-surgery","description":"Subjects will be recruited to the study from October 2015 to March 2016, prior to their elective surgical procedure. All subjects will be contacted by investigators at 90 days post-surgery. At this point, they will be asked questions regarding their current pain scores out of 10. Data collection will be complete by June 2016."},{"outcome_type":"secondary","measure":"Presence of pre-operative potential predictors of delayed opioid cessation","time_frame":"90 days post-surgery","description":"Subjects will be recruited to the study from October 2015 to March 2016, prior to their elective surgical procedure. Subjects will complete a single questionnaire prior to surgery which will collect data including their age, sex, operation type, pre-operative opioid use, depression traits, anxiety traits, addictive traits, perceived susceptibility to addiction, average hours of sleep per night, history of chronic pain, and perceived general health.\r\nThe investigators will compare subjects with and without delayed opioid cessation to see which questionnaire items were able to independently predict continued opioid use >90 days post-surgery. Data collection will be complete by June 2016."}]}
{"nct_id":"NCT02590081","start_date":"2015-10-31","phase":"Phase 4","enrollment":434,"brief_title":"Effect of Sodium Rinsing Fluid on Blood Pressure and Interdialytic Weight Change in Hemodialysis Patients","official_title":"A Prospective Randomized, Double-Blind Parallel Group Trial To Assess The Efficacy And Safety Of Intravenous Dextrose 5% Solution Compare With Normal Saline (Standard Care) In Rinsing During Haemodialysis In Subjects With End Stage Renal Failure (ESRF) With Respect To Systolic Blood Pressure Control Over 3 Months Period.","primary_completion_date":"2016-10-31","study_type":"Interventional","rec_status":"Unknown status","last_update":"2015-10-28","description":"This is a prospective, randomized, double-blind, parallel group trial to assess the efficacy and safety of intravenous dextrose 5% solution compare with normal saline (standard care) in wash back procedure during haemodialysis in patients with end stage renal failure (ESRF) with respect to systolic blood pressure control over 3 months period. The primary objective is to establish efficacy of 5% dextrose solution compared with normal saline (0.9% sodium chloride solution) with respect to systolic blood pressure control in subjects with end stage renal failure (ESRF) on regular hemodialysis. Secondary objectives include monitoring the change in body weight, thirst level and body fluid volume.","other_id":"NMRR-14-950-20443","allocation":"Randomized","intervention_model":"Parallel Assignment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":74,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Ambulatory, clinically stable maintenance HD patients on a thrice weekly HD regime.\r\n\r\n          -  Have regular hemodialysisforat least 6 months or more.\r\n\r\n          -  Willing and able to provide written, signed informed consent after the nature of the\r\n             study has been explained.\r\n\r\n          -  Willing and able to comply with all study procedures.\r\n\r\n          -  Age 18 years; Age < 75 years old\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Diabetes mellitus, Malignancy, Pregnancy\r\n\r\n          -  Inability or unwillingness to provide written consent.\r\n\r\n          -  Inability or unwillingness to comply with the requirements of the protocol as\r\n             determined by the investigator.\r\n\r\n          -  Simultaneous participation in another clinical study except observational trials\r\n\r\n          -  Any psychological condition which could interfere with the patient's ability to comply\r\n             with the study protocol\r\n\r\n          -  Inability to perform a blood pressure measurement on the upper limb\r\n\r\n          -  Scheduled for living donor kidney transplant, change to peritoneal dialysis, home HD\r\n             or plans to relocate to another center during the study period.\r\n\r\n          -  Life expectancy < 6 months\r\n\r\n          -  Recent acute myocardial infarction, congestive cardiac failure, stroke, angina or ICU\r\n             admission within last 6 months,\r\n\r\n          -  Planned to migrate/move out of the city\r\n\r\n          -  Alcohol abuse/ drug abuse within last 6 months\r\n\r\n          -  Missed > 2 hemodialysis sessions over 1 month\r\n\r\n          -  Requiring non- cuff catheter for hemodialysis\r\n\r\n          -  Admitted for major infection within the last one month\r\n      ","sponsor":"Penang Hospital, Malaysia","sponsor_type":"Other","conditions":"End-Stage Kidney Disease|Hemodialysis","interventions":[{"intervention_type":"Drug","name":"Drug: Dextrose 5%"},{"intervention_type":"Drug","name":"Drug: normal saline"}],"outcomes":[{"outcome_type":"primary","measure":"systolic blood pressure control","time_frame":"Time from week 0 until week 12","description":"post intervention systolic blood pressure reduction compared to baseline"},{"outcome_type":"secondary","measure":"Interdialytic weight gain","time_frame":"Time from week 0 until week 12","description":"reduced Interdialytic weight gain in experimental group"},{"outcome_type":"secondary","measure":"thirst level","time_frame":"Time from week 0 and week 12","description":"Dialysis thirst inventory questionnaire to be administer by patient at baseline (week 0) and end of trial (week 12)"},{"outcome_type":"secondary","measure":"intradialytic event","time_frame":"Time from week 0 until week 12","description":"Any incident occuring during hemodialysis treatment which needed medical intervention. The event are chills and rigor, chest pain, giddiness, cramps, vomiting, blood loss and hypotension."},{"outcome_type":"secondary","measure":"adverse events","time_frame":"Time from week 0 until week 12","description":"All observed or spontaneously reported adverse events occur during the trial period."}]}
{"nct_id":"NCT02847884","start_date":"2015-10-31","enrollment":28,"brief_title":"IDeaL Pilot Study - Infliximab Dose to Level: Pilot Study","official_title":"IDeaL Pilot Study - Infliximab Dose to Level: Pilot Study","primary_completion_date":"2017-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2018-06-30","last_update":"2019-05-31","description":"Crohn's disease (CD) is a lifelong condition of inflammation in the bowel. CD can affect any part of the gastrointestinal tract from mouth to anus. Symptoms can include: tiredness, stomach pain, diarrhea (which may be bloody if the disease is severe), fever, weight loss, skin rashes, arthritis and inflammation of the eye. Infliximab-IFX (Remicade) is a medication that is used to treat CD in adults and children. In adults it has been shown that the amount of this drug a person has in their blood can show how well it is working for them. Health Canada has approved Infliximab -IFX for the treatment of CD in children 9 and older. In Canada, doctors may prescribe Inflixmab to younger children when other therapies do not resolve their disease symptoms. This is called \"off-label\" use of Infliximab. IFX levels in the body and consequently its efficacy can be influenced by many biological characteristics within the patient's body. In about 17% of those treated with IFX, the patient's immune response against IFX may lead to a three to fivefold increased risk of loss of response. This immune response to the medication often occurs when drug levels are undetectable in the body. Thus it is in order to achieve best results with this treatment, physicians need to be able to adjust dosing specific to each patient. A recent study has shown that 29% of children have an undetectable IFX level at the 4th medication infusion. Up to 40% of patients receiving scheduled IFX have undetectable drug level prior to their next infusion. In order to minimize the loss of response, we hope to conduct an observational cohort study of pediatric patients treated with IFX. This open label, cohort study aims to: 1. Determine the pharmacokinetics of IFX in children with CD and the factors that affect IFX levels during the first three loading infusions 2. Obtain data to create a model that can guide and adjust the IFX dose and frequency to achieve optimal trough level between 5 and 10 ug /ml at 14 weeks.","other_id":"UAlberta","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":2,"maximum_age":17,"population":"Pediatric patients with Crohn's Disease whose treating physician has planned to start IFX\r\n        for treatment of their CD.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  A signed informed consent form by the participant's parent or legal guardian, where\r\n             applicable assent from the participant must also be obtained.\r\n\r\n          -  Aged 2 to 17 years of age\r\n\r\n          -  Known diagnosis of Crohn's Disease.\r\n\r\n          -  IFX initiated as clinically indicated.\r\n\r\n          -  Concurrent use of immunomodulators allowed.\r\n\r\n          -  Endoscopy and/OR imaging depending on disease areas in the GI tract last 3 months\r\n             (Paris classification/Simple Endoscopic Score - SES-CD).\r\n\r\n        Exclusion Criteria:\r\n\r\n         Past exposure to anti-TNF therapy\r\n      ","sponsor":"University of Alberta","sponsor_type":"Other","conditions":"Inflammatory Bowel Disease|Crohn's Disease","interventions":[{"intervention_type":"Biological","name":"Biological: Infliximab","description":"Patients will be prescribed Infliximab as a standard of care regardless of study participation."}],"outcomes":[{"outcome_type":"primary","measure":"The proportion of children with IFX trough level with the range of 5 to 10 µg/ml","time_frame":"at Week 10"},{"outcome_type":"secondary","measure":"The proportion of children with IFX trough level within the range of 5 to 10 µg/ml","time_frame":"at week 14","description":"however, participants are being treated as per standard of care. It may be possible that the dose may be administered early as deemed necessary by treating provider."},{"outcome_type":"secondary","measure":"Proportion in clinical remission and symptom response using the pediatric Crohn's disease activity index (PCDAI)","time_frame":"Beginning of the maintenance dose at the 5th dose of treatment/week 22","description":"This level will be measured prior to the 5th dose. Ideally, this will done at week 22; however, participants are being treated as per standard of care. It may be possible that the dose may be administered early as deemed necessary by treating provider."}]}
{"nct_id":"NCT02787148","start_date":"2015-10-31","phase":"N/A","enrollment":80,"brief_title":"Psychotherapy and Cardiovascular Risk Factors in Depression","official_title":"The Impact of Psychotherapy on Hemodynamic and Inflammatory Risk Factors for Cardiovascular Disease in Major Depression","primary_completion_date":"2019-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-10-31","last_update":"2021-07-28","description":"Prospective studies indicate that patients with depression are at increased risk for cardiovascular disease. Depression is also associated with a number of hemodynamic features, which are known risk factors for cardiovascular morbidity such as increased heart rate, reduced heart rate variability and blood pressure alterations. These hemodynamic alterations may explain in part the increased cardiovascular risk associated with depression. The purpose of this study is to determine whether treatment for depression with cognitive behavior therapy (CBT) is effective in reducing hemodynamic cardiovascular risk factors. Hemodynamic assessments including heart rate, heart rate variability, continues blood pressure, blood pressure variability, baroreceptor sensitivity and peripheral vascular resistance will be conducted at baseline, after treatment and 2-month follow up. In addition, circadian hemodynamic variations such as 24-hour heart rate variability, nocturnal blood pressure dipping and immunological biomarkers will be assessed. Eighty patients with Major Depression will be randomly assigned to either a CBT treatment condition (14 hour-long, weekly sessions) or a waitlist condition, to control for potential changes in hemodynamic parameters without any intervention and the impact of repeated-measurement.","other_id":"DFG EU 154 2 1","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  patients with Major Depression (DSM IV), BDI >=14\r\n\r\n          -  age:18-65 years\r\n\r\n          -  patients without antidepressive medication (stable for at least 2 weeks)\r\n\r\n          -  comorbidity with other psychiatric disorders is permitted, as far as depressive\r\n             symptoms are dominating\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  current psychotherapy\r\n\r\n          -  psychotic disorder\r\n\r\n          -  serious drug-addiction\r\n\r\n          -  drugs which seriously affect immune status (except contraceptives) or central\r\n\r\n          -  nervous system functions (except antidepressants)\r\n\r\n          -  infections during the last 2 weeks\r\n\r\n          -  injuries during the last 2 weeks\r\n\r\n          -  neurological disorders\r\n\r\n          -  diseases which affect immune status or central nervous system functions (e.g.\r\n             rheumatoid arthritis, CVD,etc.)\r\n      ","sponsor":"Philipps University Marburg Medical Center","sponsor_type":"Other","conditions":"Depression","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Cognitive behavioral therapy"}],"outcomes":[{"outcome_type":"primary","measure":"Change in depressive symptoms (BDI-II)","time_frame":"Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up"},{"outcome_type":"secondary","measure":"Change in heart rate variability","time_frame":"Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up"},{"outcome_type":"secondary","measure":"Change in blood pressure","time_frame":"Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up"},{"outcome_type":"secondary","measure":"Change in baroreceptor sensitivity (ms/mmHg)","time_frame":"Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up"},{"outcome_type":"secondary","measure":"Change in peripheral vascular resistance (dyne*s/cm5)","time_frame":"Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up"},{"outcome_type":"secondary","measure":"Change in C-reactive protein","time_frame":"Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up"},{"outcome_type":"secondary","measure":"Change in proinflammatory cytokines","time_frame":"Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up"},{"outcome_type":"secondary","measure":"Change in anti-inflammatory interleukin-10","time_frame":"Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up"},{"outcome_type":"secondary","measure":"Change in Subjective social status (MacArthur scale)","time_frame":"Change from baseline (beginning of therapy) to 3 month after baseline, to 2-month-follow up"}]}
{"nct_id":"NCT02487563","start_date":"2015-10-31","phase":"Phase 3","enrollment":97,"brief_title":"Prospective Study of Patients With Thrombocytopenia Following HSCT","official_title":"A Prospective Study of Patients With Isolated Thrombocytopenia Following Hematopoietic Stem Cell Transplantation","primary_completion_date":"2019-04-12","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-04-12","last_update":"2020-05-06","description":"Isolated thrombocytopenia is a common and severe complication of HSCT, which often leads to an increased risk of life-threatening hemorrhage, frequent requirement of platelet transfusions and extended hospital stays, representing a challenging clinical problem. Current treatments for thrombocytopenia after HSCT are frequently unsatisfactory in platelet recovery and for preventing potentially fatal bleeding complications. Therefore, it is urgent to explore an effective therapy to improve the outcomes of thrombocytopenia after HSCT. Previous studies have demonstrated that decitabine, a hypomethylating agent, may reduce platelet transfusions in myelodysplastic syndrome (MDS) patients. The investigators conducted an prospective clinical trial to evaluate the safety and efficiency of rhTPO and decitabine in the treatment of thrombocytopenia following HSCT.","other_id":"SOOCHOW-HY-2015","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Platelet count  30  109/L persistently at day 60 post-HSCT or later;\r\n\r\n          2. Neutrophil and hemoglobin were well recovered;\r\n\r\n          3. Full donor chimerism was achieved;\r\n\r\n          4. No response to conventional treatments (e.g. thrombopoietin, immunoglobulin,\r\n             glucocorticoid alone or in combination) for a duration of at least 4 weeks;\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients with malignancy relapse;\r\n\r\n          2. Active infections;\r\n\r\n          3. Grade - acute GVHD or severe chronic GVHD according to National Institute of Health\r\n             criteria;\r\n\r\n          4. Severe organ damage;\r\n\r\n          5. Thrombosis requiring treatment;\r\n\r\n          6. Received decitabine following the current transplantation.\r\n      ","sponsor":"The First Affiliated Hospital of Soochow University","sponsor_type":"Other","conditions":"Thrombocytopenia|Hematologic Diseases","interventions":[{"intervention_type":"Drug","name":"Drug: Decitabine","description":"Decitabine"},{"intervention_type":"Drug","name":"Drug: rhTPO","description":"rhTPO"},{"intervention_type":"Other","name":"Other: Conventional Treatment","description":"immunoglobulin, glucocorticoid etc"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants With Platelet Count Recovery","time_frame":"Up to 4 weeks after the treatment","description":"Platelet response refers to a sustained increase (stable or increasing level) of at least 30×10E9/L independent of transfusion for 3 days."},{"outcome_type":"secondary","measure":"Megakaryocyte Count","time_frame":"Up to 4 weeks after the treatment","description":"The total number of megakaryocytes as well as the platelet-shedding megakaryocytes of bone marrow smears (per cm2) was counted and cross-checked by blinded observers."}]}
{"nct_id":"NCT02587468","start_date":"2015-10-31","phase":"N/A","enrollment":20,"brief_title":"Bioavailability and Absorption Kinetics of Phenolic Compounds and Specific Vitamins","official_title":"Bioavailability and Absorption Kinetics of Phenolic Compounds and Specific Vitamins of a Commercially Available, Encapsulated Nutraceutical (Juice Plus+)","primary_completion_date":"2017-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-07-31","last_update":"2017-08-01","description":"GOAL To identify absorption kinetics and bioavailability of phenolic compounds and specific vitamins from encapsulated Juice Plus+ powder ENDPOINTS - Absorption kinetics of phenolic compounds in plasma - Bioavailability of vitamins C, E, and carotenoids into plasma Subjects: 20 healthy subjects from Graz region, meeting all inclusion criterions (see underneath).","other_id":"27-507 ex 14/15","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  20 healthy men and women, 20-50 years old;\r\n\r\n          -  non-smokers;\r\n\r\n          -  BMI >20 und <30 kg/m2;\r\n\r\n          -  no medication;\r\n\r\n          -  premenopausal;\r\n\r\n          -  normal dietary habits (no specific diets, meals, food components etc.);\r\n\r\n          -  adherence to wash-out period.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  all people not meeting the inclusion criterions;\r\n\r\n          -  diet: subjects consuming >4 servings of fruits and vegetables per day;\r\n\r\n          -  subjects with any kind of food allergy or histamine intolerance;\r\n\r\n          -  highly trained subjects (> 5 training units/week);\r\n\r\n          -  women with menstrual dysfunctions;\r\n\r\n          -  pregnancy\r\n\r\n          -  alcoholics.\r\n      ","sponsor":"Green Beat","sponsor_type":"Other","conditions":"Healthy","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Juice Plus+(R)","description":"before-after comparison of plasma phenolics"}],"outcomes":[{"outcome_type":"primary","measure":"Absorption kinetics of phenolic acids after 1, 2, 5 and 10 hours, measured via HPLC, evaluated by repeated measures ANOVA, and assessed via SPSS 19.0.","time_frame":"1 year","description":"For the phenolics analyses subjects come to the lab after an overnight fast, and after 2 weeks wash-out of all food supplements and 48 hours wash-out of phytonutrients (phytonutrient-poor diet). To adhere to the phytonutrient-poor diet they receive an exact diet plan in the forefront. This plan will be perused with the research associate. After the baseline blood drawing, they receive 3 capsules of Juice Plus+® consumed with 250ml plain water from the pipe. They will be instructed to swallow one capsule of each blend (fruit, berry, vegetable). During this day 4 additional blood samples will be drawn: 1hr, 2hrs, 5hrs, 10hrs after capsule intake in the morning.\r\nAfter the 2hrs blood sampling the subjects get a standardized, phytonutrient-poor snack: white bread, cheese, ham, milk and water ad libitum. Subjects will receive a list with suggestions of allowed food they could consume on this day."},{"outcome_type":"secondary","measure":"Absorption of ß-carotene after 8 weeks of supplementation, measured via HPLC, evaluated by paired t-test, and assessed via SPSS 19.0","time_frame":"1 year","description":"Two weeks after the first blood drawings, for the phytonutrient absorption and absorption kinetics, subjects will be invited to another visit to the laboratory. During these two weeks the volunteers adhere to the wash-out from all food supplements. After an overnight fast they come to the lab for the baseline blood drawings to evaluate vitamins and carotenoids absorption. This procedure will be repeated after 8 weeks of supplementation with 6 capsules of Juice Plus+® per day (~2.2g juice powder per day). During this time subjects will be instructed to maintain their habitual diet."}]}
{"nct_id":"NCT03133845","start_date":"2015-10-31","phase":"N/A","enrollment":218,"brief_title":"Shaping Anesthetic Techniques to Reduce Post-operative Delirium","official_title":"Shaping Anesthetic Techniques to Reduce Post-Operative Delirium","primary_completion_date":"2020-05-25","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-05-25","last_update":"2020-06-18","description":"The purpose of this study is to determine if light sedation with spinal anesthesia reduces the incidence of delirium compared to receiving general anesthesia during spinal surgery in older adults.","other_id":"IRB00113655","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female patients age 65 and over.\r\n\r\n          -  Patients undergoing lumbar fusion performed by Dr. Charles Edwards II, Dr. Charles\r\n             Edwards, Dr. Clayton Dean , or Dr. Justin Park at Mercy Medical Center.\r\n\r\n          -  Expected length of surgery <3 hours.\r\n\r\n          -  Ability to understand study procedures and to comply with them for the entire length\r\n             of the study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Contradictions to spinal anesthesia (severe aortic stenosis, anti-coagulant or\r\n             antiplatelet medications, other)\r\n\r\n          -  Body mass index > 40 kg/m2\r\n\r\n          -  prior lumbar fusion from L2-L5 in entirety\r\n\r\n          -  Communication issues precluding delirium assessment or sedation\r\n\r\n          -  Dementia or mini-mental status exam score < 24\r\n\r\n          -  Psychiatric disease that would preclude cooperation with sedation with spinal\r\n             anesthesia\r\n\r\n          -  Any other reason that the attending anesthesiologist or surgeon feels that clinical\r\n             circumstances dictate a strong preference for either spinal or general anesthesia.\r\n\r\n          -  Inability or unwillingness of individual or legal guardian/representative to give\r\n             written informed consent.\r\n      ","sponsor":"Johns Hopkins University","sponsor_type":"Other","conditions":"Delirium|Lumbar Radiculopathy|Lumbar Osteoarthritis|Lumbar Spine Disc Degeneration","interventions":[{"intervention_type":"Procedure","name":"Procedure: Administration of intrathecal morphine","description":"Patient may receive intrathecal morphine for post-operative pain control."},{"intervention_type":"Procedure","name":"Procedure: Light sedation with propofol","description":"Patients having lumbar spinal surgery and receiving spinal anesthesia will receive propofol for light sedation."},{"intervention_type":"Procedure","name":"Procedure: Induction with propofol","description":"Patients having lumbar spinal surgery and receiving general anesthesia will receive propofol and their induction agent."},{"intervention_type":"Procedure","name":"Procedure: Maintenance anesthetic using a volatile anesthetic","description":"Patients having lumbar spinal surgery and receiving general anesthesia will receive a volatile anesthetic for their maintenance anesthesia."},{"intervention_type":"Procedure","name":"Procedure: Muscle relaxant during maintenance anesthesia","description":"Patients having lumbar spinal surgery and receiving general anesthesia with receive a muscle relaxant for muscle paralysis."},{"intervention_type":"Procedure","name":"Procedure: Pain control with fentanyl","description":"Patients having lumbar spinal surgery and receiving general anesthesia will receive fentanyl for their pain during surgery."},{"intervention_type":"Procedure","name":"Procedure: Bispectral Index (BIS) monitoring for depth of anesthesia","description":"All patients will be monitored with Bispectral Index (BIS) to monitor the patient's depth of anesthesia."},{"intervention_type":"Procedure","name":"Procedure: Spinal Anesthesia","description":"Patients receiving spinal anesthesia will receive bupivacaine into the subarachnoid space."},{"intervention_type":"Procedure","name":"Procedure: Midazolam administered during spinal anesthesia","description":"Midazolam may be administered during spinal needle insertion for patients receiving spinal anesthesia."},{"intervention_type":"Procedure","name":"Procedure: Cerebrospinal fluid collection","description":"8 ml of cerebrospinal fluid may be collected prior to the administration of intrathecal administration of morphine for pain control."}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of delirium","time_frame":"First 3 postoperative days","description":"The patient will be assessed for delirium using the Confusion Assessment Method on each of the first 3 post-operative days."},{"outcome_type":"secondary","measure":"Assessment of cognitive status at 3 months using the Verbal Fluency Test","time_frame":"3 months after surgery","description":"The participant will be administered the Verbal Fluency Test to measure verbal fluency. Participants are given 1 minute to name as many words as possible beginning with a letter. Participants are then given 1 minute to name as many words as possible beginning with a different letter. Participants are then given 1 minute to name as many words as possible in a category. The score is the total number of different words produced for all 3 trials and will be compared to the score obtained at baseline."},{"outcome_type":"secondary","measure":"Assessment of cognitive status at 1 year using the Verbal Fluency test.","time_frame":"1 year after surgery","description":"The participant will be administered the Verbal Fluency Test to measure verbal fluency. Participants are given 1 minute to name as many words as possible beginning with a letter. Participants are then given 1 minute to name as many words as possible beginning with a different letter. Participants are then given 1 minute to name as many words as possible in a category. The score is the total number of different words produced for all 3 trials and will be compared to the score obtained at baseline."},{"outcome_type":"secondary","measure":"Assessment of functional status at 3 months using the Instrumental Activities of Daily Living (IADL) test.","time_frame":"3 months after surgery","description":"At 3 months, the participant's functional status will be assessed using the instrumental activities of daily living (IADL) scales. Scores can range from 0-14 with 14 being high functioning and 0 being low functioning. This score will be compared to the baseline score."},{"outcome_type":"secondary","measure":"Assessment of functional status at 1 year using the Instrumental Activities of Daily Living (IADL) test.","time_frame":"1 year after surgery","description":"At 1 year, the participant's functional status will be assessed using the instrumental activities of daily living (IADL) scales. Scores can range from 0-14 with 14 being high functioning and 0 being low functioning. This score will be compared to the baseline score."},{"outcome_type":"secondary","measure":"Assessment of functional status at 3 months using the Short Form 12 Health Survey (SF-12)","time_frame":"3 months after surgery","description":"This is a survey that measures the patient's own self reported view on their health. Scores range from 0-100, with 0 indicating the lowest level of health and 100 indicating the highest level of health."},{"outcome_type":"secondary","measure":"Assessment of functional status using at 1 year the Short Form 12 Health Survey (SF-12)","time_frame":"1 year after surgery","description":"This is a survey that measures the patient's own self reported view on their health. Scores range from 0-100, with 0 indicating the lowest level of health and 100 indicating the highest level of health."},{"outcome_type":"secondary","measure":"Assessment of functional status at 3 months using the Oswestry Disability Index (ODI)","time_frame":"3 months after surgery","description":"This survey measures self-reported disability due to low pain. Scores range from 0-100, with 0 being minimal or no disability and 100 being severe disability. This score will be compared to the baseline score."},{"outcome_type":"secondary","measure":"Assessment of functional status at 1 year using the Oswestry Disability Index (ODI)","time_frame":"1 year after surgery","description":"This survey measures self-reported disability due to low pain. Scores range from 0-100, with 0 being minimal or no disability and 100 being severe disability. This score will be compared to the scores obtained at baseline and 3 months after surgery."},{"outcome_type":"secondary","measure":"Assessment of cognitive status at 3 months using Trail Making Test","time_frame":"3 months after surgery","description":"This test provides information visual search speed, scanning, speed of processing, mental flexibility, and executive functioning. The test is scored by the amount of time it takes to complete the test in seconds. This score will be compared to the score obtained at baseline."},{"outcome_type":"secondary","measure":"Assessment of cognitive status at 1 year using Trail Making Test","time_frame":"1 year after surgery","description":"This test provides information visual search speed, scanning, speed of processing, mental flexibility, and executive functioning. The test is scored by the amount of time it takes to complete the test in seconds. This score will be compared to the scores obtained at baseline and 1 year after surgery."},{"outcome_type":"secondary","measure":"Assessment of cognitive status at 3 months using the Digit Span","time_frame":"3 months after surgery","description":"The Digit Span is used to measure the participant's memory span and number storage capacity. The scores range from 0-9 with 0 being short term memory impairment and 9 be no short term memory impairment. This score will be compared to the score obtained at baseline."},{"outcome_type":"secondary","measure":"Assessment of cognitive status at 1 year using the Digit Span","time_frame":"1 year after surgery","description":"The Digit Span is used to measure the participant's memory span and number storage capacity. The scores range from 0-9 with 0 being short term memory impairment and 9 be no short term memory impairment. This score will be compared to the scores obtained at baseline and 3 months after surgery."},{"outcome_type":"secondary","measure":"Assessment of the cognitive status at 3 months using the Mini Mental Status Exam","time_frame":"3 months after surgery","description":"The mini mental status exam measures cognitive impairment. Scores range from 0-30 with 0 being severe cognitive impairment and 30 being no cognitive impairment. This score will be compared to the score obtained at baseline."},{"outcome_type":"secondary","measure":"Assessment of the cognitive status at 1 year using the Mini Mental Status Exam","time_frame":"1 year after surgery","description":"The mini mental status exam measures cognitive impairment. Scores range from 0-30 with 0 being severe cognitive impairment and 30 being no cognitive impairment. The score obtained will be compared to the scores obtained at baseline and 3 months after surgery."},{"outcome_type":"secondary","measure":"Assessment of cognitive status at 3 months after surgery using the Telephone Interview for Cognitive Status (TICS)","time_frame":"3 months after surgery","description":"The telephone interview for cognitive status will only be used it the study team is unable to conduct the mini mental status exam in person. This test assesses cognitive function with scores ranging from 0-40 with 0 being severe cognitive impairment and 41 being no cognitive impairment."},{"outcome_type":"secondary","measure":"Assessment of cognitive status at 1 year using the Telephone Interview for Cognitive Status (TICS)","time_frame":"1 year after surgery","description":"The telephone interview for cognitive status will only be used it the study team is unable to conduct the mini mental status exam in person. This test assesses cognitive function with scores ranging from 0-40 with 0 being severe cognitive impairment and 41 being no cognitive impairment."},{"outcome_type":"secondary","measure":"Maximum severity of delirium during hospital stay","time_frame":"Through the end of hospitalization, up to 3 months","description":"The patient will be assessed for delirium using the maximum total score on the Delirium Rating Scale-Revised 1998. The scale range is 0-32, with 0 being low delirium severity and 32 being high delirium severity."},{"outcome_type":"secondary","measure":"Number of participants with hospital readmissions within 30 days of discharge","time_frame":"30 days from hospital discharge","description":"Hospital readmissions will be measured."},{"outcome_type":"secondary","measure":"Number of participants with emergency room visit within 30 days of hospital discharge","time_frame":"30 days from hospital discharge","description":"Emergency Room Visits will be measured."},{"outcome_type":"secondary","measure":"Number of days in hospital after surgery","time_frame":"Immediately after surgery until discharge, up to 3 months","description":"The number of days in hospital after surgery will be calculated for each patient."},{"outcome_type":"secondary","measure":"Last pain score in the post-anesthesia care unit","time_frame":"Immediately before leaving the post-anesthesia care unit, up to 1 day","description":"The last pain score on the NRS pain scale of 0-10 taken in the post-anesthesia care unit by the post-anesthesia care unit staff. For this scale, 0 indicates no pain and 10 indicates the most severe pain."},{"outcome_type":"secondary","measure":"Total morphine equivalents of opioids given in the post-anesthesia care unit","time_frame":"During post-anesthesia care unit stay, up to 1 week","description":"The total amount of opioids given to each patient in the post-anesthesia care unit will be converted to morphine equivalents for each patient."},{"outcome_type":"secondary","measure":"Time first opioid given in the post-anesthesia care unit","time_frame":"The time the first opioid medication is given to the patient in the post-anesthesia care unit, up to 1 week","description":"The time will be noted when the first opioid is given to each participant in the post-anesthesia care unit."},{"outcome_type":"secondary","measure":"Last pain score prior to hospital discharge","time_frame":"Immediately before hospital discharge","description":"The last pain score recorded for each participant on the NRS pain scale of 0-10. For this scale, 0 indicates no pain and 10 indicates the most severe pain."},{"outcome_type":"secondary","measure":"Total amount of morphine equivalents during hospital stay","time_frame":"Duration of the hospital length of stay, up to 3 months","description":"The total amount of morphine equivalents will be measure for each participants hospital stay. The amount measured will be pro-rated tp the participant's length of stay."},{"outcome_type":"secondary","measure":"The average pain score at 3 month follow-up","time_frame":"one week prior to end of 3 month follow-up","description":"The average pain score for each participant on the NRS pain scale of 0-10 over the week prior to the 3 month follow-up. These score are compared to scores from baseline assessments. For this scale, 0 indicates no pain and 10 indicates the most severe pain."},{"outcome_type":"secondary","measure":"The average pain score at 12 month follow-up","time_frame":"one week prior to end of 12 month follow-up","description":"The average pain score for each participant on the NRS pain scale of 0-10 over the week prior to the 12 month follow-up. These score are compared to scores from baseline assessments. For this scale, 0 indicates no pain and 10 indicates the most severe pain."},{"outcome_type":"secondary","measure":"Number of days with delirium","time_frame":"Duration of the hospital stay, up to 3 months","description":"The number of days with delirium will measured for each participant during the length of the hospital stay for each participant."}]}
{"nct_id":"NCT02560818","start_date":"2015-10-31","phase":"N/A","enrollment":20,"brief_title":"Transcriptomes Breast, Ovarian and Leukocyte Hereditary Genes Predisposing to Breast and / or Ovarian Cancer","official_title":"Transcriptomes Breast, Ovarian and Leukocyte Hereditary Genes Predisposing to Breast and / or Ovarian Cancer","primary_completion_date":"2020-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-10-31","last_update":"2020-11-09","description":"This is a case-control study of molecular diagnostics. This study requires two steps: - The first part of the study will be conducted on a population of 20 women without breast cancer and, or ovarian family (Healthy Volunteers controls) - The second part of the study will be conducted on a population of 50 patients predisposed to familial breast and, or ovarian cancer compared to 20 controls . For analysis of leucocytes of the patients, a blood sample collected in a prior study (EXSAL study, ID-RCB 2009-A00833-54) will be used.","other_id":"CASOHAR","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        For Healthy Volunteers\r\n\r\n        Inclusion Criteria:\r\n\r\n        For population A\r\n\r\n          -  Women without a history of breast cancer and / or ovarian cancer and no family history\r\n             of breast and / or ovarian cancer among family members on the 1st and 2nd degree\r\n             before age 50 for breast cancer and before age 60 for ovarian cancer\r\n\r\n          -  Age 18-65 years\r\n\r\n          -  Women targeted for breast reduction surgery\r\n\r\n          -  Agreeing to participate in the study (collection of signed informed consent)\r\n\r\n        For population B\r\n\r\n          -  Women over the age of 18, with no previous history of breast and / or ovarian cancer\r\n             and no family history of breast and / or early ovarian cancer in first and second\r\n             degree relatives, ( diagnosis before age 50 for breast cancer and before age 60 for\r\n             ovarian cancer).\r\n\r\n          -  Women to be operated on for a hysterectomy with annexectomy or an annexectomy in a\r\n             benign indication\r\n\r\n        For population C :\r\n\r\n          -  Women with a history of breast cancer between 50 and 65 years of age but no history of\r\n             ovarian cancer and no family history of breast and / or ovarian cancer in first- and\r\n             second-degree relatives before 50 years of age breast cancer and before age 60 for\r\n             ovarian cancer\r\n\r\n          -  Women who have been treated for breast cancer and undergoing contralateral\r\n             symmetrization surgery\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Men\r\n\r\n          -  Personal history (for population A and B) or family history (populations A, B, C) of\r\n             breast and / or ovarian cancer (known breast or ovarian cancer in their family of 1st\r\n             and 2nd degree before age 50 for breast cancer and before age 60 for ovarian cancer)\r\n\r\n          -  Population C: breast cancer under 50 years\r\n\r\n          -  Persons deprived of liberty or guardianship (including curatorship)\r\n      ","sponsor":"Centre Francois Baclesse","sponsor_type":"Other","conditions":"Breast Cancer|Transcriptomes|Molecular Diagnostic|Ovarian Cancer","interventions":[{"intervention_type":"Other","name":"Other: collection of a blood sample and breast and ovarian tissue","description":"a blood sample and a breast and ovarian tissue sample will be collected in healthy women during their surgery (breast or ovarian surgery according to selection group :A, B or C)"},{"intervention_type":"Other","name":"Other: use of a previous blood collection for patients"}],"outcomes":[{"outcome_type":"primary","measure":"Difference between the average rate of inclusion of exons (exon inclusion mean level) messenger RNA leucocyte of patients and the controls (without matching)","time_frame":"at inclusion"},{"outcome_type":"secondary","measure":"Difference between the average rate of inclusion of exons (exon inclusion mean level) leukocyte messenger RNAs and, the mRNA of breast tissue in healthy women (with pairing).","time_frame":"at inclusion"}]}
{"nct_id":"NCT03321253","start_date":"2015-10-23","phase":"N/A","enrollment":38,"brief_title":"Changes of Macular Pigment and Parameters of Eyes After YAG Laser Treatment in Cases With Capsule Opacification","official_title":"Changes of Macular Pigment Optical Density and Parameters After Nd: YAG Laser Posterior Capsulotomy in Cases With Posterior Capsule Opacification","primary_completion_date":"2016-04-12","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-05-16","last_update":"2019-08-07","description":"It has been hypothesized that potential effects of laser Nd: YAG laser posterior capsulotomy may affect macular pigment as well as choroidal thickness, macular thickness and anterior chamber parameters, so it was aimed to investigate possible effects of Nd: YAG laser posterior capsulotomy on macular pigment optical density, choroidal thickness, macular thickness and anterior chamber parameters in cases with posterior capsule opacification in this study.","other_id":"2011-KAEK-2 2017/172","intervention_model":"Sequential Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"sequential self-controlled clinical trial","sampling_method":"","gender":"All","minimum_age":45,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Best-corrected visual acuity (BCVA) logMAR <0.3\r\n\r\n          -  Duration at least 2 years after cataract surgery\r\n\r\n          -  Between the ages of 45 and 65 years (45age65)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Corneal scarring, diffuse posterior PCO or intravitreal hemorrhage that prevents\r\n             appearance of the fundus\r\n\r\n          -  Occluded angle by gonioscopy (grade 0, narrow angle, grade I, grade II)\r\n\r\n          -  Presence of macular or peripheral retinal pathologies or choroidopathy\r\n\r\n          -  High risk for RD\r\n\r\n          -  Presence of macular edema in the macular area\r\n\r\n          -  Detection of macular fluid or edema in OCT\r\n\r\n          -  Active intraocular inflammation\r\n\r\n          -  Previous laser PRP, Nd: YAG laser posterior capsulotomy, laser iridotomy or selective\r\n             laser trabeculoplasty interventions\r\n\r\n          -  Previous iridectomy, glaucoma or vitreoretinal surgery\r\n\r\n          -  Glass intraocular lens\r\n\r\n          -  Spherical refractive error  6.00 D or cylinder refractive error  3.00 D\r\n\r\n          -  Inadequate stability of the eye\r\n\r\n          -  Systemic diseases that may affect the choroidal blood flow such as cardiological\r\n             diseases\r\n\r\n          -  Current use of carotenoid supplementation\r\n\r\n          -  Changing eating habits\r\n\r\n          -  Gastrointestinal diseases that could cause disturbance of dietary absorption\r\n      ","sponsor":"Afyon Kocatepe University Hospital","sponsor_type":"Other","conditions":"Posterior Capsule Opacification|Retinal Degeneration|Retinal Detachment|Anterior Chamber Angle Congestion|Macula Edema|Macular Pigmentation|Choroid Disease","interventions":[{"intervention_type":"Device","name":"Device: Nd: YAG laser posterior capsulotomy","description":"Nd: YAG laser posterior capsulotomy"}],"outcomes":[{"outcome_type":"primary","measure":"Changes of Foveal and Pericentral Pigment Optical Density (Log Unit) From Baseline at 2 Months","time_frame":"2 months","description":"Foveal and pericentral pigment optical density was measured by using color perimetry technique and recorded as log unit before Nd: YAG laser posterior capsulotomy, at 1 week, 1 month and 2 months"},{"outcome_type":"primary","measure":"Changes of Subfoveal, Temporal and Nasal Choroidal Thicknesses (Micrometer) From Baseline at 2 Months","time_frame":"2 months","description":"Subfoveal, temporal and nasal choroidal thicknesses were measured by using enhanced-deep imaging optical coherence tomography and recorded as micrometer before Nd: YAG laser posterior capsulotomy, at 1 week, at 1-month and at 2-month"},{"outcome_type":"primary","measure":"Changes of Anterior Chamber Depth (Millimeter) From Baseline at 2 Months","time_frame":"2 months","description":"Anterior chamber depth was measured by using anterior segment module optical coherence tomography and recorded as millimeter before Nd: YAG laser posterior capsulotomy, at 1 week, at 1-month and at 2-month"},{"outcome_type":"primary","measure":"Changes of Iridocorneal Angle From Baseline at 2 Months","time_frame":"2 months","description":"Iridocorneal angle was measured by using anterior segment module optical coherence tomography and recorded as millimeter before Nd: YAG laser posterior capsulotomy, at 1 week, at 1-month and 2-month"},{"outcome_type":"secondary","measure":"Changes of Central Macular Thicknesses (Micrometer) From Baseline at 2 Months","time_frame":"2 Months"}]}
{"nct_id":"NCT02470247","start_date":"2015-10-06","phase":"N/A","enrollment":26,"brief_title":"Interest of Remote Ischemic Preconditioning for Prevention of Contrast Medium-induced Nephropathy in High Risk Patients","official_title":"IPC-Angio Trial : Interest of Remote Ischemic Preconditioning for Prevention of Contrast Medium-induced Nephropathy (Post-diagnostic Imaging) in Patients at High Risk of Contrast-induced Nephropathy","primary_completion_date":"2017-08-24","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-10-31","last_update":"2021-01-07","description":"Diagnostic imaging for vascular investigations and endovascular procedures frequently require the use of contrast medium. Besides contrast medium-induced hypersensitivity, an acute kidney injury can appear: the contrast-induced nephropathy (NPCI). NPCI is associated with an increase of patients' morbidity and mortality. One of the conventional methods proposed to limit this NPCI is an oral administration of N-acetylcysteine (NAC) associated with hydration performed 12 hours before and 12 hours after the injection. However, in some patients this method cannot be performed due to a high risk of heart failure although they are generally at high risk of NPCI. Recently, it has been shown, in a randomized trial, that remote ischemic preconditioning (several cycles of upper-arm ischemia-reperfusion with a pressure cuff inflator) associated with hydratation and NAC reduced the occurrence of NPCI after a coronary angiography as compared with NAC and hydration only. . We hypothesized that the use of RIPC in patients at high risk of NPCI and who cannot receive NAC and hydratation (e.g. patients with aortic stenosis and eligible for Transcatheter Aortic Valve Implantation (TAVI)) could be promising.","other_id":"35RC14_9899_IPC-Angio Trial","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age greater than 18 years, no upper age limit ;\r\n\r\n          -  Patient which may hospitalized for a medical check-up before a percutaneous aortic\r\n             valve implantation (CTA and coronarography);\r\n\r\n          -  Patient at risk for NPCI defined by a Mehran risk classification system 11 (Annexe 2)\r\n             ;\r\n\r\n          -  Willing to provide free and informed written consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pathology of the upper-limbs limiting the use of the cuff (bilateral amputation,\r\n             arteriovenous fistula);\r\n\r\n          -  Critical renal disease requiring hemodialysis ;\r\n\r\n          -  Person who is not affiliated to a health care system insurance\r\n\r\n          -  Inability to understand the instructions of the study;\r\n\r\n          -  Absolute contraindication to of iodinated contrast medium injection (anaphylactic\r\n             shock history to contrast media, especially Xenetix, clearance (MDRD) less than\r\n             30mL/min/1.73m2) ;\r\n\r\n          -  Pregnancy\r\n\r\n          -  Simultaneous participation in other protocol;\r\n\r\n          -  Person with legal protection, person deprived of liberty.\r\n      ","sponsor":"Rennes University Hospital","sponsor_type":"Other","conditions":"Nephropathy","interventions":[{"intervention_type":"Other","name":"Other: Remote Ischemic Preconditioning (RIPC)","description":"RIPC is accomplished by performing 4 cycles of alternating 5-minute inflation and 5-minute deflation of a standard upper-arm blood pressure cuff, to induce transient and repetitive arm ischemia and reperfusion.\r\nRIPC will be started just before the CTA, and the time between the last inflation cycle and the beginning of the CTA will be less than 45 minutes."},{"intervention_type":"Other","name":"Other: SHAM Remote Ischemic Preconditioning (SHAM RIPC)","description":"The SHAM Remote Ischemic Preconditioning (\"SHAM\" RIPC) will be carried out with the same number of cycles that the RIPC but cuff will be inflated to the diastolic pressure of the subject and the cuff will be deflated to10 mmHg in order to maintain a non- ischemic compression (blind patient protocol)."}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of NPCI","time_frame":"48 hours","description":"Incidence of NPCI defined as an increase in serum creatinine ≥ 0.5 mg / dL or a relative increase of 25 % above baseline at 48 hours after contrast medium exposure."},{"outcome_type":"secondary","measure":"Cystatin C","time_frame":"2 days","description":"Changes of serum Cystatin C between day 0 and day 1, and day 0 and day 2."},{"outcome_type":"secondary","measure":"Oxydative stress","time_frame":"24 hours","description":"Changes in markers of oxydative stress (in the first 40 patients included) :\r\nat day 0, after the RIPC procedure or SHAM-RIPC procedure (+ 5 min) before CTA ;\r\nafter CTA (+ 30 min) and 24 hours after CTA (day 1)."},{"outcome_type":"secondary","measure":"Renal function","time_frame":"6 days","description":"Changes in serum creatinine and Cystatin C between day 0 and measured values after coronarography (day 6 )."},{"outcome_type":"secondary","measure":"Pain","time_frame":"Day 0","description":"A standardized pain scale (ranged from 0 to 10; 0 : no pain; 10 : maximum of pain)."},{"outcome_type":"secondary","measure":"Mortality","time_frame":"6 months","description":"Assessment of mortality at six months."}]}
{"nct_id":"NCT02560584","start_date":"2015-10-01","phase":"Phase 3","enrollment":304,"brief_title":"A Study of Blue Light Flexible Cystoscopy With Cysview in the Detection of Bladder Cancer in the Surveillance Setting","official_title":"A Prospective, Open, Comparative, Within Patient Controlled Multicenter Phase 3 Study of Blue Light Cystoscopy With Cysview and White Light Cystoscopy Using KARL STORZ D-Light C PDD Flexible Videoscope System in Detection of Bladder Cancer in Patients With Bladder Cancer","primary_completion_date":"2017-04-05","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-04-05","last_update":"2018-07-02","description":"The purpose of this study is to investigate if blue light cystoscopy with Cysview improves detection of tumors in patients with bladder cancer during surveillance cystoscopy, using the KARL STORZ D-Light C PDD Flexible Videoscope System. Another purpose is to investigate if Cysview and blue light is safe and effective when used repeatedly.","other_id":"PC B308/13","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","intervention_model_description":"This is a prospective, open, comparative, within-patient controlled Phase 3 multicenter study in patients with bladder cancer. There is a maximum of three study visits for an enrolled patient:\r\nVisit 1: Screening visit Visit 2: Surveillance cystoscopy in white light (WL) followed by blue light (BL) Visit 3: Operating room (OR) cystoscopy in WL followed by BL for patients with suspicion of recurrence after surveillance cystoscopy.\r\nCystoscopy in WL followed by BL is performed in all patients after Cysview instillation. Only patients with suspicious lesions at Visit 2 continue to a second cystoscopy in WL followed by BL at Visit 3.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        1. Patients with bladder cancer in follow-up for tumor recurrence (Note: Patients must be\r\n             included only at the first surveillance cystoscopy after a histologically confirmed\r\n             tumor. The histologically confirmed tumor could either be from a TURB or from a\r\n             surveillance cystoscopy where a biopsy was taken and a tumor was confirmed by\r\n             histology)\r\n\r\n          2. History of one or more of the following:\r\n\r\n               -  Multiple tumors\r\n\r\n               -  Recurrent tumors\r\n\r\n               -  High grade tumor(s)\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Gross haematuria. (Note: Gross haematuria is defined as a heavy bladder bleed\r\n             resulting in significant amounts of blood in the urine, which may visually limit\r\n             cystoscopy. Where the haematuria is light, the patient should not be excluded, if in\r\n             the investigator's opinion, rinsing and/or electro-cautery during cystoscopy will\r\n             alleviate the haematuria limitations to cystoscopy)\r\n\r\n          2. Patients who cannot undergo in-office or operating room cystoscopy (Note: Training\r\n             patients are eligible even if they cannot undergo operating room cystoscopy)\r\n\r\n          3. Patients who have received Bacillus Calmette-Gurin (BCG) immunotherapy or\r\n             intravesical chemotherapy within the past 6 weeks prior to the procedure\r\n\r\n          4. Porphyria\r\n\r\n          5. Known allergy to hexaminolevulinate hydrochloride or a similar compound\r\n\r\n          6. Pregnancy or breast-feeding (all women of child-bearing potential must document a\r\n             negative urine pregnancy test before study inclusion and use adequate contraception\r\n             during the study\r\n\r\n          7. Participation in other clinical studies with investigational drugs either concurrently\r\n             or within the last 30 days\r\n\r\n          8. Patient is the investigator or any sub investigator, research assistant, pharmacist,\r\n             study coordinator, other staff or relative thereof directly involved in the conduct of\r\n             the protocol\r\n\r\n          9. Patients that the investigator believes are unlikely to comply with the protocol, e.g.\r\n             mental condition rendering the patient unable to understand the nature, scope, and\r\n             possible consequences of participating in the clinical study, uncooperative attitude\r\n             or unlikelihood of completing the study\r\n      ","sponsor":"Photocure","sponsor_type":"Industry","conditions":"Bladder Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Hexaminolevulinate hydrochloride","description":"Instillation in bladder"},{"intervention_type":"Device","name":"Device: KARL STORZ D-Light C PDD Flexible Videoscope System","description":"Cystoscopy procedure"}],"outcomes":[{"outcome_type":"primary","measure":"Proportion of Patients With Histologically Confirmed Malignancy Where Malignancy is Only Detected With Blue Light Cystoscopy With Cysview and Not White Light Cystoscopy","time_frame":"At time of cystoscopy procedure","description":"In the subsection of patients with histologically confirmed malignancy, the proportion of patients detected only by the use of blue light cystoscopy with Cysview is measured."},{"outcome_type":"secondary","measure":"Proportion of Patients With Adverse Events Considered Causally Related to Cysview and/or Blue Light in the Surveillance Examination Compared With the OR Examination","time_frame":"At time of cystoscopy procedure"},{"outcome_type":"secondary","measure":"Proportion of Patients With One or More Carcinoma in Situ (CIS) Lesions Detected With Blue Light Cystoscopy With Cysview and None With White Light Cystoscopy","time_frame":"At time of cystoscopy procedure","description":"In the subsection of patients with histologically confirmed CIS, the proportion of patients detected only by blue light cystoscopy with Cysview is measured."}]}
{"nct_id":"NCT04474769","start_date":"2015-10-01","phase":"N/A","enrollment":114,"brief_title":"Supporting New Graduated Nurse's Professional Competence, a Theoretical Model for Optimal Orientation","official_title":"Supporting New Graduated Nurse's Professional Competence, a Theoretical Model for Optimal Orientation","primary_completion_date":"2017-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-11-30","last_update":"2020-07-17","description":"This research is a longitudinal quasi-experimental intervention study which aim is to study education intervention's impact on new graduate nurses' orientation period, professional competence and organizational commitment. The study hypothesis is that new graduate nurses who start to work at the nursing unit which belong to the intervention group are more satisfied on received orientation, their professional competence develops faster and they are more committed to the organization than new graduate nurses at the units of the control group.","other_id":"PreceptOR2014","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"None (Open Label)","intervention_model_description":"Longitudinal quasi-experimental intervention study","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Less than one year from the graduation, willingness to participate\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Already a registered nurse, more than one year from the graduation\r\n      ","sponsor":"Tampere University","sponsor_type":"Other","conditions":"Competence|Nurse's Role","interventions":[{"intervention_type":"Other","name":"Other: Educational intervention for preceptors"}],"outcomes":[{"outcome_type":"primary","measure":"Professional competence, the change of the professional competence is being assessed","time_frame":"Baseline","description":"Nurse Competence Scale, min 0 to max 100. Higher scores means better outcome"},{"outcome_type":"primary","measure":"Professional competence, the change of the professional competence is being assessed","time_frame":"Three months","description":"Nurse Competence Scale, min 0 to max 100. Higher scores means better outcome"},{"outcome_type":"primary","measure":"Professional competence, the change of the professional competence is being assessed","time_frame":"Nine months","description":"Nurse Competence Scale, min 0 to max 100. Higher scores means better outcome"},{"outcome_type":"secondary","measure":"Precepting experience","time_frame":"Three months","description":"Clinical Learning Environment Scale, min 1 to max 10. Higher scores means better outcome"},{"outcome_type":"secondary","measure":"Organizational commitment","time_frame":"Nine months","description":"Nurse Engament Survey, min 1 to max 5. Higher scores means better outcome"}]}
{"nct_id":"NCT02947997","start_date":"2015-09-30","enrollment":4,"brief_title":"Pilot Study for Imaging of the Esophagus Using Tethered Capsule OCT Endomicroscopy With Distal Scanning","official_title":"Pilot Study for Imaging of the Esophagus Using Tethered Capsule OCT Endomicroscopy With Distal Scanning","primary_completion_date":"2015-11-30","study_type":"Observational","rec_status":"Completed","completion_date":"2015-12-31","last_update":"2019-11-14","description":"The purpose of this study is to test feasibility of a redesigned tethered capsule catheter that contains an integrated micro-motor. Investigators will be testing imaging of this new technology in healthy volunteers.","other_id":"2015-P000777","observational_model":"Case-Only","time_perspective":"Cross-Sectional","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"Healthy Volunteers","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subjects must be over the age of 18\r\n\r\n          -  Subjects must be able to give informed consent\r\n\r\n          -  Subjects must have no solid food for 4 hours prior to the procedure, and only clear\r\n             liquids for 2 hours prior to the procedure.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subjects with the inability to swallow pills and capsules.\r\n\r\n          -  Esophageal fistula and/or esophageal strictures with a stricture diameter that is\r\n             smaller than the diameter of the capsule.\r\n\r\n          -  Subjects who have a bleeding disorder and are currently on anti-coagulants.\r\n      ","sponsor":"Massachusetts General Hospital","sponsor_type":"Other","conditions":"Healthy","interventions":[{"intervention_type":"Device","name":"Device: OFDI capsule","description":"Imaging of esophagus using OFDI capsule and system"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants For Whom Good Quality Images Were Recorded After Swallowing The OFDI Capsule","time_frame":"Approximate 20 minute visit (5 min image acquisition)","description":"An investigator to assess the quality of the recorded images obtained with each exam after imaging has been completed"}]}
{"nct_id":"NCT02673216","start_date":"2015-09-30","enrollment":2200,"brief_title":"Infection and Adverse Pregnancy Outcome","official_title":"Infection and Adverse Pregnancy Outcome","primary_completion_date":"2020-12-31","study_type":"Observational","rec_status":"Active, not recruiting","completion_date":"2023-12-31","last_update":"2021-05-10","description":"Miscarriage (spontaneous abortion, stillbirth, and preterm birth) is the most common adverse out-come of pregnancy and a significant proportion is caused by infection. The investigators aim to study vaginal specimens from 1200 pregnant women recruited before 14 weeks of gestation with follow-up at mid-term (week 19) as well as 300 women aborting spontaneously. Adverse pregnancy outcome will be correlated to the presence of bacterial vaginosis (BV) subclasses, to vaginal fluid inflammation markers, and to the presence of novel Chlamydia-like bacteria, in particular Waddlia chondrophila. Species specific quantitative PCR assays for BV-related bacteria as well as next-generation-sequencing will be applied on selected specimens with the aim to identify markers allowing for a personalised treatment approach.","other_id":"1-10-72-116-14","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"Female","population":"Pregnant women attending for antenatal care or with spontaneous miscarriage","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Pregnancy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  None\r\n      ","sponsor":"Statens Serum Institut","sponsor_type":"Other","conditions":"Preterm Birth","interventions":[{"intervention_type":"Other","name":"Other: No intervention"}],"outcomes":[{"outcome_type":"primary","measure":"Preterm birth <37 weeks of gestation","time_frame":"37 weeks of gestation"}]}
{"nct_id":"NCT02712840","start_date":"2015-09-30","phase":"N/A","enrollment":1,"brief_title":"Comparing Pregnancy Outcomes in Good Prognosis Patients Between Fresh and 'Freeze-All' Single Blastocyst Transfers","official_title":"Pregnancy Outcomes in Good Prognosis Patients Utilizing Fresh Single Blastocyst Transfer vs. 'Freeze-All' and Delayed Frozen Single Blastocyst Transfer","primary_completion_date":"2018-03-26","study_type":"Interventional","rec_status":"Terminated","completion_date":"2018-03-26","last_update":"2018-03-29","description":"The purpose of this study is to determine whether the chances of becoming pregnant are better when day the single best day 5 embryo (blastocyst) resulting from an in vitro fertilization (IVF) cycle is transferred into the uterus immediately, or after freezing the embryo and transferring it into the uterus in a subsequent cycle, separate from the ovarian stimulation used in the IVF cycle. The investigators hypothesize that in good-prognosis patients, vitrified-warmed elective single embryo transfer will result in higher implantation, clinical and on-going pregnancy and live birth rates than fresh elective single embryo transfer at the blastocyst stage.","other_id":"15-0167-A","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":35,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  First IVF cycle\r\n\r\n          -  Normal ovarian reserve parameters (antral follicle count > 12, follicle stimulating\r\n             hormone (FSH) < 10 IU/L, AMH (if measured) > 15 pmol/L)\r\n\r\n          -  Infertility cause due to tubal factor, male factor with ejaculated sperm or\r\n             unexplained\r\n\r\n          -  3 or more fresh transfer or cryopreservation-quality blastocysts on day 5\r\n             post-oocyte-retrieval\r\n\r\n          -  GnRH antagonist or long GnRH agonist cycles\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Evidence of (or evidence for significant risk of) ovarian hyperstimulation syndrome\r\n             (OHSS) on post-oocyte-retrieval day 5 (in which the standard protocol is not to\r\n             perform a fresh embryo transfer, but rather to freeze all blastocysts for future\r\n             frozen embryo transfers).\r\n\r\n          -  Use of a gonadotropin releasing hormone (GnRH) agonist trigger for ovulation and\r\n             resulting intensive luteal phase support protocol.\r\n\r\n          -  Women requiring automatic freeze-all approaches (such as for pre-implantation genetic\r\n             testing or cryopreservation for fertility preservation).\r\n\r\n          -  Female infertility causes that may adversely affect implantation, such as severe\r\n             endometriosis, fibroids, mullerian abnormalities, or prior uterine procedures\r\n             resulting in a potentially compromised endometrial cavity.\r\n\r\n          -  In-vitro maturation of oocytes\r\n\r\n          -  Oocyte donation cycles\r\n      ","sponsor":"Mount Sinai Hospital, Canada","sponsor_type":"Other","conditions":"Infertility","interventions":[{"intervention_type":"Procedure","name":"Procedure: Freeze-All Protocol","description":"All good morphologic quality blastocysts are vitrified on day 5 or 6. The best quality vitrified blastocyst frozen on day 5 will be warmed and transferred in a subsequent cycle."},{"intervention_type":"Procedure","name":"Procedure: Fresh Protocol","description":"Participants receive fresh embryo transfer of best morphologic quality blastocyst on day 5 and vitrification of all good quality supernumerary blastocysts."}],"outcomes":[{"outcome_type":"primary","measure":"Ongoing pregnancy rate","time_frame":"12 weeks of gestation","description":"Ongoing pregnancy is a pregnancy with a positive heart beat beyond 12 weeks of gestation."},{"outcome_type":"secondary","measure":"Implantation rate","time_frame":"4-5 weeks after date of embryo transfer","description":"Implantation rate is the number of gestational sacs seen via transvaginal ultrasonography 4-5 weeks after embryo transfer, per number of embryos transferred."},{"outcome_type":"secondary","measure":"Clinical pregnancy rate","time_frame":"4-5 weeks after date of embryo transfer","description":"Clinical pregnancy is the presence of a gestational sac seen by transvaginal ultrasonography 4-5 weeks after embryo transfer."},{"outcome_type":"secondary","measure":"Cumulative implantation rate","time_frame":"4-5 weeks after date of blastocyst transfer","description":"Implantation rate for all blastocysts transferred from the same ovarian hyperstimulation IVF cycle. Includes all blastocysts transferred fresh and/or vitrified (depending upon arm of study)."},{"outcome_type":"secondary","measure":"Cumulative clinical pregnancy rate","time_frame":"4-5 weeks after the date of blastocyst transfer","description":"Clinical pregnancy rate for all blastocysts transferred from the same ovarian hyperstimulation IVF cycle. Includes all blastocysts transferred fresh and/or vitrified (depending upon arm of study)."},{"outcome_type":"secondary","measure":"Cumulative ongoing pregnancy rate","time_frame":"12 weeks of gestation for each pregnancy achieved","description":"Ongoing pregnancy rate for all blastocysts transferred from the same ovarian hyperstimulation IVF cycle. Includes all blastocysts transferred fresh and/or vitrified (depending upon arm of study)."},{"outcome_type":"secondary","measure":"Live birth rate","time_frame":"10 months post-blastocyst transfer","description":"Number of live births achieved per blastocyst transfer"},{"outcome_type":"secondary","measure":"Cryopreservation thaw rate","time_frame":"12 months","description":"Percentage of vitrified blastocysts which survive warming"}]}
{"nct_id":"NCT02529774","start_date":"2015-09-30","phase":"Phase 2/Phase 3","enrollment":432,"brief_title":"Alternating Systemic and Hepatic Artery Infusion Therapy As Adjuvant Treatment After Resection of Liver Metastases From Colorectal Cancer","official_title":"Efficacy and Safety of Alternating Systemic and Hepatic Artery Infusion Therapy Versus Systemic Chemotherapy Alone As Adjuvant Treatment After Resection of Liver Metastases From Colorectal Cancer: A Randomized, Parallel-Group, Open-Labelled, Active-Controlled Phase II/III Trial in China","primary_completion_date":"2020-09-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2021-09-30","last_update":"2015-08-20","description":"This adaptive seamless Phase II/III trial is to compare the efficacy and safety of adjuvant systemic chemotherapy (SCT) with or without hepatic arterial infusion (HAI) after complete hepatic resection for Chinese patients with metastatic colorectal cancer.","other_id":"1507149-6","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Diagnosis Criteria:\r\n\r\n        All patients should have histologically confirmed colorectal adenocarcinoma with hepatic\r\n        metastases and primary tumours completely resected during the operation and with colorectal\r\n        metastatic to the liver confirmed pathologically after the operation as well as with\r\n        negative surgical margin.\r\n\r\n        Main criteria for inclusion:\r\n\r\n          -  Aged 18-75 years\r\n\r\n          -  Diagnosed as colorectal adenocarcinoma which only spread to the liver and with no\r\n             extra-hepatic metastases\r\n\r\n          -  Prior curative resection of primary tumours (R0 resection) or concurrent feasible\r\n             curative resection of primary tumours and hepatic metastases (R0 resection is met)\r\n\r\n          -  Performance status ECOG 0-1\r\n\r\n          -  No serious complication occurred during or after metastases resection and affected\r\n             subsequent treatment.\r\n\r\n          -  Hematology: White blood count  4.0X10^9/L, Absolute neutrophil count 1.5X10^9/L,\r\n             Platelet count  100 X10^9/L, Hemoglobin  100g/L\r\n\r\n          -  Blood biochemistry: Total bilirubin 2mg/dL , Direct bilirubin equal or less than 1.5\r\n             times upper limit of normal (ULN), Alanine aminotransferase (ALT) no greater than 2.5\r\n             times ULN, Aspartate aminotransferase (AST) no greater than 2.5 times ULN, Serum\r\n             creatinine no greater than ULN, or glomerular filtration rate equal or greater than 60\r\n             mL/min/1.73m^2\r\n\r\n          -  Not pregnant or nursing at present\r\n\r\n          -  Fertile patients must use effective contraception\r\n\r\n          -  Able to withstand major operative procedure\r\n\r\n          -  No prior or concurrent malignancy within the past 5 years except basal cell or\r\n             squamous cell skin cancer or carcinoma in situ of any organ\r\n\r\n          -  No prior hepatic artery infusion therapy with 5-FU or floxuridine\r\n\r\n          -  No prior systemic chemotherapy for metastatic disease\r\n\r\n          -  No other concurrent chemotherapy\r\n\r\n          -  Able to understand and sign off informed consent form\r\n      ","sponsor":"Ye Xu","sponsor_type":"Other","conditions":"Resected Liver Metastases From Colorectal Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Floxuridine (FUDR),Dexamethasone (DXM), Heparin in combination with Oxaliplatin and Capecitabine (CapeOX) or in combination with Oxaliplatin and Leucovorin and 5-FU (mFOLFOX6)","description":"Hepatic Artery Infusion for four cycles:\r\nFloxuridine (FUDR) 500mg/d, Day 1-2; DXM 1mg/day added to FUDR 2-day infusion; Heparin 1000U/day added to FUDR 2-day infusion\r\nIn combination with Systemic Chemotherapy CapeOX for 8 cycles:\r\nOxaliplatin 130 mg/m^2 iv over 2 hours, Day 1. Capecitabine 850mg/m^2/d PO Bid, given in the morning and evening, Day 1-14\r\nOr in combination with Systemic Chemotherapy mFOLFOX6 for 12 cycles:\r\nOxaliplatin 85mg/m^2 IV over 2 hours, Day 1. Leucovorin 400mg/m^2 IV over 2 hours, Day 1 5-fluorouracil (FU) 400mg/m^2 IV and then 2400mg/m^2 over 48 hours IV continuous infusion. Day 1"},{"intervention_type":"Drug","name":"Drug: Oxaliplatin and Capecitabine (CapeOX) or Oxaliplatin and Leucovorin and 5-FU (mFOLFOX6)","description":"Systemic Chemotherapy CapeOX alone for 8 cycles:\r\nOxaliplatin 130 mg/m^2 iv over 2 hours, Day 1. Capecitabine 850mg/m^2/d PO Bid, given in the morning and evening, Day 1-14\r\nOr Systemic Chemotherapy mFOLFOX6 alone for 12 cycles:\r\nOxaliplatin 85mg/m^2 IV over 2 hours, Day 1. Leucovorin 400mg/m^2 IV over 2 hours, Day 1 5-fluorouracil (FU) 400mg/m^2 IV and then 2400mg/m^2 over 48 hours IV continuous infusion. Day 1"}],"outcomes":[{"outcome_type":"primary","measure":"Overall Survival","time_frame":"5-year","description":"Overall survival will be measured from the date of randomization up to the date of death of any cause"},{"outcome_type":"primary","measure":"Liver Relapse-Free Survival Rate","time_frame":"3-year","description":"Liver Relapse-Free Survival (LRFS) is defined as the interval from the date of randomization to the date of liver localized metastatic relapse (with the exception of curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix) or death from any cause whichever occurs first."},{"outcome_type":"secondary","measure":"Disease free survival","time_frame":"3-year","description":"DFS is defined as the time interval from the date of randomization to the time of the first relapse at any site, death from any cause, or last recorded follow-up visit."}]}
{"nct_id":"NCT02651727","start_date":"2015-09-30","phase":"Phase 1","enrollment":13,"brief_title":"Ph 1 Study of VS-4718, a FAK Inhibitor, in Combination With Nab-paclitaxel and Gemcitabine in Advanced Cancer Subjects","official_title":"A Phase 1 Study of VS-4718, a Focal Adhesion Kinase Inhibitor, in Combination With Nab-paclitaxel and Gemcitabine in Subjects With Advanced Cancer","primary_completion_date":"2017-01-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2017-01-31","last_update":"2017-07-27","description":"The purpose of this study is to evaluate increasing dose levels of VS-4718 administered in combination with gemcitabine and nab-paclitaxel in subjects with advanced cancer and to determine a recommended Phase 2 dose (RP2D) for further development of this combination in subjects with untreated advanced pancreatic cancer.","other_id":"VS-4718-103","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age  18 years\r\n\r\n          -  Histologically or cytologically confirmed diagnosis of an advanced nonhematological\r\n             malignancy (Part A) or advanced pancreatic adenocarcinoma (Part B) that is not\r\n             surgically resectable\r\n\r\n          -  Eligible for treatment with nab-paclitaxel and gemcitabine on Days 1, 8, and 15 in\r\n             28-day cycles as standard therapy\r\n\r\n          -  Evaluable or measurable disease, as assessed by RECIST v1.1\r\n\r\n          -  ECOG performance status of  1\r\n\r\n          -  Adequate renal function (creatinine  1.5ULN [upper limit of normal]) or glomerular\r\n             filtration rate of  60 mL/min\r\n\r\n          -  Adequate hepatic function (total bilirubin  1.5ULN for the institution; aspartate\r\n             transaminase and alanine transaminase  2.5ULN, or  5ULN if due to liver\r\n             involvement by tumor; albumin  3 g/dL)\r\n\r\n          -  Adequate bone marrow function (hemoglobin  9.0 g/dL; unsupported platelets  100109\r\n             cells/L; absolute neutrophil count [ANC]  1.5109 cells/L without the use of\r\n             hematopoietic growth factors)\r\n\r\n          -  Corrected QT interval (QTc) < 470 ms\r\n\r\n          -  Willing and able to participate in the trial and comply with all trial requirements\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Gastrointestinal (GI) condition that could interfere with the swallowing or absorption\r\n             of study medication\r\n\r\n          -  Uncontrolled or severe concurrent medical condition (including uncontrolled brain\r\n             metastases).\r\n\r\n          -  History of upper gastrointestinal bleeding, ulceration, or perforation within 6 months\r\n             prior to the first dose of protocol therapy\r\n\r\n          -  Known history of stroke or cerebrovascular accident within 6 months prior to the first\r\n             dose of protocol therapy.\r\n\r\n          -  Part B only: Prior therapy (including investigational agents) for pancreatic cancer\r\n\r\n          -  Chemotherapy or radiotherapy within 14 days prior to first dose of protocol therapy\r\n\r\n          -  Active treatment for a secondary malignancy\r\n      ","sponsor":"Verastem, Inc.","sponsor_type":"Industry","conditions":"Pancreatic Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Part B, Cohort 1- VS-4718, nab-paclitaxel, gemcitabine","description":"IV treatment in 28-day cycles (nab-paclitaxel 125 mg/m2 over 30 minutes on Days 1, 8, and 15 and gemcitabine at 1000 mg/m2 over 30 minutes on Days 1, 8, and 15) and oral VS 4718 BID continuously starting on Day 1 of Cycle 1"},{"intervention_type":"Drug","name":"Drug: Part B, Cohort 2- VS4718, nab-paclitaxel, gemcitabine","description":"IV treatment for the first 2 cycles, followed by IV treatment and oral VS-4718 BID continuously starting on Day 1 of Cycle 3"},{"intervention_type":"Drug","name":"Drug: Part A- VS-4718, nab-paclitaxel, gemcitabine","description":"Part A- intravenous (IV) treatment in 28-day cycles (nab-paclitaxel 125 mg/m2 over 30 minutes on Days 1, 8, and 15 and gemcitabine at 1000 mg/m2 over 30 minutes on Days 1, 8, and 15) and oral VS 4718 twice-daily (BID) continuously starting on Cycle 1 Day 2. The starting dose of VS-4718 will be 200 mg BID."}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of dose-limiting toxicities (DLTs)","time_frame":"6 months","description":"Dose Escalation Phase: Frequency of DLTs at each dose level associated with administration of VS-4718 in combination with gemcitabine and nab-paclitaxel"},{"outcome_type":"secondary","measure":"Progression Free Survival","time_frame":"From the date of first treatment to the date of progression including death from any cause, expected average at least 5 months"},{"outcome_type":"secondary","measure":"Response rate (RR)","time_frame":"Every 8 weeks from baseline through the end of treatment, an expected average of 5 months]","description":"RR is measured as the best overall response using Response Evaluation Criteria In Solid Tumors (RECIST), version 1.1."},{"outcome_type":"secondary","measure":"Pharmacokinetics of VS-4718 in combination with nab-paclitaxel and gemcitabine: Clearance","time_frame":"Time points on Day 1, 2,15, 16, and 22 in Cycle 1; Day 1 of each subsequent cycle"},{"outcome_type":"secondary","measure":"Pharmacokinetics of VS-4718 in combination with nab-paclitaxel and gemcitabine: Plasma concentration","time_frame":"Time points on Day 1, 2,15, 16, and 22 in Cycle 1; Day 1 of each subsequent cycle"},{"outcome_type":"secondary","measure":"Pharmacokinetics of VS-4718 in combination with nab-paclitaxel and gemcitabine: Area under the plasma concentration versus time curve (AUC)","time_frame":"Time points on Day 1, 2,15, 16, and 22 in Cycle 1; Day 1 of each subsequent cycle"},{"outcome_type":"secondary","measure":"Pharmacokinetics of VS-4718 in combination with nab-paclitaxel and gemcitabine: Maximum observed plasma concentration (Cmax)","time_frame":"Time points on Day 1, 2,15, 16, and 22 in Cycle 1; Day 1 of each subsequent cycle"},{"outcome_type":"secondary","measure":"Pharmacokinetics of VS-4718 in combination with nab-paclitaxel and gemcitabine: Time to reach maximum observed concentration (Tmax)","time_frame":"Time points on Day 1, 2,15, 16, and 22 in Cycle 1; Day 1 of each subsequent cycle"},{"outcome_type":"secondary","measure":"Pharmacokinetics of VS-4718 in combination with nab-paclitaxel and gemcitabine: Half life (T1/2)","time_frame":"Time points on Day 1, 2,15, 16, and 22 in Cycle 1; Day 1 of each subsequent cycle"}]}
{"nct_id":"NCT02549846","start_date":"2015-09-30","phase":"Phase 4","enrollment":270,"brief_title":"AdminiStration of Statin On Acute Ischemic stRoke patienT Trial","official_title":"Randomized Controlled Trial of Early Versus Late Statin Therapy in Patients With Ischemic Stroke","primary_completion_date":"2016-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-03-31","last_update":"2018-02-27","description":"Investigators will study whether immediate statin treatment after the onset of stroke is beneficial on the neurological protection","other_id":"UMIN000021032","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":20,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  the Informed consent will be acquired by the document.\r\n\r\n          -  Age: 20 years of age or older.\r\n\r\n          -  Gender: unquestioned\r\n\r\n          -  hospitalization, outpatient: hospital\r\n\r\n          -  Patients by MRI at the time of hospital transport, it has been confirmed diagnosed\r\n             with cerebral infarction\r\n\r\n          -  ingestible in within 24 hours after admission In the study treatment period, patients\r\n             that can be defined treatment in this clinical study implementation plan\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  patients with a history of hypersensitivity to the treatment agent of the present\r\n             study\r\n\r\n          -  Patients acute hepatitis, chronic hepatitis acute exacerbation, liver cirrhosis, it is\r\n             believed that the liver cancer, liver function jaundice or the like is reduced, or a\r\n             biliary obstruction\r\n\r\n          -  Patients suspected of being pregnant or pregnant\r\n\r\n          -  Patients in the administration of the cyclosporine or telaprevir\r\n\r\n          -  patients with moderate or severe renal impairment (SCr  2.5mg / dL or eGFR <30mg /\r\n             dL)\r\n\r\n          -  Patients who received a diagnosis of acute coronary syndrome within 6 months\r\n\r\n          -  valvular disease, atrial fibrillation, patients with atrial thrombus\r\n\r\n          -  Patients familial hypercholesterolemia\r\n\r\n          -  patient admission NIHSS score is greater than or equal to 3 is more than 20 or before\r\n             the onset mRS score\r\n\r\n          -  patients with other doctors deemed inappropriate\r\n      ","sponsor":"Hyogo College of Medicine","sponsor_type":"Other","conditions":"Ischemic Stroke","interventions":[{"intervention_type":"Drug","name":"Drug: Statin","description":"Randomized controlled trial of early versus late statin therapy in patients with ischemic stroke"}],"outcomes":[{"outcome_type":"primary","measure":"modified Rankin Scale","time_frame":"12 weeks from stroke onset","description":"Scale range from 0 [no symptom] to 6 [dead]"}]}
{"nct_id":"NCT02617797","start_date":"2015-09-30","phase":"Phase 2/Phase 3","enrollment":42,"brief_title":"Radiofrequency in the Female Stress Urinary Incontinence","official_title":"Radiofrequency in the Female Stress Urinary Incontinence: A Randomized Clinical Trial","primary_completion_date":"2016-02-29","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2016-07-31","last_update":"2015-12-01","description":"Urinary stress incontinence ( SUI ) is defined as an involuntary loss of urinary Complaint no effort According to the Consensus of the International Continence Society (Society Continene International - ICS) . SUI Prevalence of adult female Population and 25 % to 30 %.However, despite the high prevalence, many women who have symptoms of SUI or not seek treatment remain without resolution of symptoms.Then there is the possibility of using non-invasive radiofrequency and non-ablation in external urethral meatus in order to stimulate collagen production, as one of the pathophysiological mechanisms of stress urinary incontinence is the collagen deficit in the urethral wall. It is a randomized clinical trial and the group experimental will utilize radiofrequency and cinesioteraphy ( clinical and in home) and the group control utilize turn off- radiofrequency and cinesiotherapy(clinical and in home). The protocol f the cinesiotherapu is the same both the group, and the protocol radiofrequency the group experimental will 5 sessions (one per week) with temperature 38C during 2 minuts. The group control will 5 sessions (one per week) but the radiofrequency will off but glycerin is heated, for masking for the patient, during 2 min. The result of the treatment is assessed by pad test 1 hour and have others outcomes ( quality of life- Sf-26 ans King Health- and sexual function- FSFI questionaire)","other_id":"U1111-1162-0945","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":59,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  21 Women with age between 18-59 years old,\r\n\r\n          -  women with diagnosis of urinary incontinence and have a Pelvic floor muscle\r\n             contractility was assessed by digital palpation using the validated Modified Oxford\r\n             Scale (MOS) greater than or equal to three\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with cognitive deficits or psychiatric illness;\r\n\r\n          -  suffering from chronic degenerative neurological diseases; which have greater than 50\r\n             ml post-voiding residue ;\r\n\r\n          -  sensory deficit in the genital region;\r\n\r\n          -  people with pacemakers and implantable cardioverter-defibrillator and pregnant women\r\n             will be excluded from the study\r\n      ","sponsor":"Centro de Ateno ao Assoalho Plvico","sponsor_type":"Other","conditions":"Urinary Stress Incontinence","interventions":[{"intervention_type":"Device","name":"Device: Radiofrequecy","description":"The radiofrequency is a noninvasive technique that will be applied to the external urethral meatus region.It will use a digital thermometer with infrared to mention the temperature should reach 39  C and maintain this temperature for 2 minutes.It will use a digital thermometer with infrared to mention the temperature should reach 39  C and maintain this temperature for 2 minutes"},{"intervention_type":"Device","name":"Device: Radiofrequency OFF","description":"Will be used to put off radio frequency will be heated glycerin to occur masking for the patient."}],"outcomes":[{"outcome_type":"primary","measure":"Urinary loss modification","time_frame":"one week, one month, two month , theree month and six month","description":"The pad test will be held at the beginning of treatment and one week, one month , two month , theree month and six month after the last session of radio frequency. The pad test it quantifies in grams urinary loss through the absorbent weighing."},{"outcome_type":"secondary","measure":"specific Quality of life","time_frame":"one week","description":"The quality of life will be assessed by one for especific urinary symptoms - Health King , measuare with unit of the scale"},{"outcome_type":"secondary","measure":"Sexual Function","time_frame":"one week","description":"Will be evaluated before and after radio frequency sexual function of women, through quetionario FSFI in which there is a switching station which evaluates the presence of sexual dysfunction, and there is specific scores for the domains of pain, desire, lubrication, arousal, orgasm, and satisfaction."},{"outcome_type":"secondary","measure":"overall quality of life","time_frame":"one week","description":"Will be evaluated before and after radio frequency the overall quality of life - SF-36 - questionaire."}]}
{"nct_id":"NCT02551978","start_date":"2015-09-30","phase":"N/A","enrollment":60,"brief_title":"Kids Obesity Prevention Program - Study (KOP)","official_title":"Kids Obesity Prevention Program - Study (KOP). A Serious Game to Address Barriers to Prevention and Treatment of Obesity in Primary School Children","primary_completion_date":"2015-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-11-30","last_update":"2015-11-30","description":"Obesity and its associated comorbidities are becoming a key and rapidly growing public health problem. The cause of obesity is an imbalance between energy intake and energy expenditure in favor of the former. Childhood and adolescence are seen as critical time for its development. It is therefore crucial to provide both prevention and treatment actions already during childhood. The prevention and treatment weight-management programs in children focus on improving diet, eating behaviours, psychosocial aspects and increasing physical activity. One important basic requirement for any weight-management program is, that both children and their families are motivated and ready for change. Video games, including exergames, serious games or combined approaches offer additional chances in the treatment and prevention of obesity by approaching children in their environment and motivating them to deal with life-style topics. The investigators developed a motion-controlled serious game for children aged between 9 and 12 years, addressing all the three core areas nutrition, physical activity, and psychosocial factors. In addition to the motion control, a tablet is used for knowledge-based and cognitive tasks. In comparison to other studies the nutrition part not only deals with the food pyramid but also with the energy density of foods and liquids and offers a self-reflexive diagnostic tool to analyse daily food intake. Moreover, psychological aspects, especially stress and stress-coping strategies are addressed e.g. by relaxation-exercises. The game consists of two sessions, having each a duration of about 35 minutes. The aim of this study is to evaluate the program in a cluster-randomized controlled trial in a primary school setting in children aged 9 to 12 years. Therefore, six 4th grade classes of the same school will be randomly allocated to an intervention and a control group. The intervention group will play the game within two weeks, whereas the control group will receive basic information. At baseline, two weeks after baseline and at four weeks follow-up, measurements will be performed. The primary outcome of the study is the gain of knowledge (nutrition, psychosocial aspects) measured by a self-constructed questionnaires tailored specifically for the serious game. Secondary outcomes are the acceptance of the game, changes of nutrition behaviour, physical activity and intentions of the children to follow a healthy lifestyle, measured by mostly validated questionnaires.","other_id":"KOP_1","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":9,"maximum_age":12,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  all children which belong to the 4th graders of a primary school\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  children with massive linguistic difficulties will be excluded (after study\r\n             participation; due to ethical reasons we can not do this ahead)\r\n      ","sponsor":"University Hospital Tuebingen","sponsor_type":"Other","conditions":"Obesity|Child","interventions":[{"intervention_type":"Other","name":"Other: The serious game KOP","description":"The serious game transfers knowledge about nutrition (food pyramid, energy density of foods, which foods contribute to satiety and which not, energy in liquids, self-reflexive diagnostic tool to analyze daily food intake), physical activity (a motion-control to navigate through the game is partly used, relationship between energy expenditure and energy intake) and psychological aspects (relaxation-exercises, what is stress, stress-coping strategies)."}],"outcomes":[{"outcome_type":"primary","measure":"Knowledge of the children about nutrition and psychosocial aspects by a self-developed questionnaire specific for the serious game","time_frame":"Change between baseline and two weeks after the baseline measurement"},{"outcome_type":"secondary","measure":"Nutrition Score (Ernährungsmusterindex) by Kleiser et al., 2007 used in the KIGGS cohort (Studie zur Gesundheit von Kindern und Jugendlichen in Deutschland)","time_frame":"Change between baseline and four weeks follow-up (on average 6 weeks after baseline measurement))","description":"Parents and children are independently asked to report the food frequencies for key foods in order to calculate the Ernährungsmuster index"},{"outcome_type":"secondary","measure":"Food frequency of specific foods which are addressed in the serious game","time_frame":"Change between baseline and four weeks follow-up (on average 6 weeks after baseline measurement))","description":"Parents and children are independently asked to report the food frequencies of specific foods"},{"outcome_type":"secondary","measure":"Physical activity using a validated questionnaire filled in by the children and also the parents","time_frame":"change between baseline and four weeks follow-up (on average 6 weeks after baseline measurement))","description":"Parents and children are independently asked to fill in the questionnaire"},{"outcome_type":"secondary","measure":"Intentions of children to stick to a healthy lifestyle by using a tailored questionnaire specific for the contents of the serious game","time_frame":"Change between baseline, and two weeks after baseline measurement, and four weeks follow-up"},{"outcome_type":"secondary","measure":"Acceptance of the serious game by the children using a self-developed questionnaire specific for the serious game","time_frame":"At baseline and directly after the end of the second session of the game (on average two weeks after baseline measurement)"}]}
{"nct_id":"NCT02800616","start_date":"2015-09-30","phase":"N/A","enrollment":2349,"brief_title":"The Healthy Elementary School of the Future","official_title":"The Healthy Elementary School of the Future","primary_completion_date":"2019-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-07-31","last_update":"2020-09-22","description":"Unhealthy lifestyles in early childhood are a major global health challenge. These lifestyles often persist from generation to generation and contribute to a vicious cycle of health-related and social problems. We present a study protocol that examines the effectiveness of two novel, integrated healthy school interventions. One is a full intervention called 'The Healthy Primary School of the Future', the other is a partial intervention called 'The Physical Activity School'. These intervention approaches will be compared with the regular school approach that is currently common practice in the Netherlands. The main outcome measure will be changes in children's body mass index (BMI). In addition, lifestyle behaviours, academic achievement, child well-being, socio-economic differences, and societal costs will be examined.","other_id":"UM MOVARE GGD","allocation":"Non-Randomized","intervention_model":"Factorial Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":4,"maximum_age":12,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  All children and their caregivers enrolled at one of the participating schools\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  None. Participants who switch schools during the four-year study period will not be\r\n             followed-up.\r\n      ","sponsor":"Maastricht University","sponsor_type":"Other","conditions":"Overweight|Physical Activity|Malnutrition|Child Development|Lifestyle-related Condition|Socioeconomic Difficulty","interventions":[{"intervention_type":"Other","name":"Other: The Healthy Primary School of the Future","description":"In two out of four intervention schools, a whole-school approach named 'The Healthy Primary School of the Future', is implemented with the aim of improving physical activity and dietary behaviour. For this intervention, pupils are offered an extended curriculum, including a healthy lunch, more physical exercises, and social and educational activities, next to the regular school curriculum."},{"intervention_type":"Behavioral","name":"Behavioral: The Physical Activity School","description":"In the two other intervention schools, a physical-activity school approach called 'The Physical Activity School', is implemented, which is essentially similar to the other intervention, except that no lunch is provided."}],"outcomes":[{"outcome_type":"primary","measure":"Child absolute change in BMI Z-score, based on weight and height.","time_frame":"Four years","description":"Weight is measured using a weighing scale, to the nearest 0.1 kg; height is measured using a measuring rod, to the nearest 0.1 cm."},{"outcome_type":"secondary","measure":"Child hip and waist circumferences","time_frame":"Four years","description":"Using a measuring tape, to the nearest 0.1 cm, following the World Health Organization's assessment protocol"},{"outcome_type":"secondary","measure":"Child handgrip strength","time_frame":"Four years","description":"Measured using a calibrated Jamar hydraulic hand dynamometer to the nearest 0.5 kg"},{"outcome_type":"secondary","measure":"Child disease status","time_frame":"Four years","description":"Self-report measure (online parental questionnaire) since birth, hospital admissions (number and duration), healthcare visits (number), and medication use in the previous twelve months"},{"outcome_type":"secondary","measure":"Child pre-school blood pressure, birth weight, and information on disease history.","time_frame":"Obtained once","description":"Data previously obtained by the regional Public Health Services."},{"outcome_type":"secondary","measure":"Parental BMI","time_frame":"Four years","description":"Self-report measure (online parental questionnaire)."},{"outcome_type":"secondary","measure":"Parental practices regarding nutrition","time_frame":"Four years","description":"Self-report measure (online parental questionnaire).Using the shortened version (nine items) of the Comprehensive Snack Parenting Questionnaire (CSPQ)"},{"outcome_type":"secondary","measure":"Parental practices regarding physical activity","time_frame":"Four Years","description":"Self-report measure (online parental questionnaire).questionnaire developed in the same style as he Comprehensive Snack Parenting Questionnaire (CSPQ)"},{"outcome_type":"secondary","measure":"Labour participation of parents","time_frame":"Four years","description":"Current employment status (self reported) is combined with parental education level and household income to determine socio economic status (SES)."},{"outcome_type":"secondary","measure":"Parents' ethnicity and level of (material) deprivation","time_frame":"Four years","description":"Self-report measure (online parental questionnaire)."},{"outcome_type":"secondary","measure":"Parental sick leave and absence from work or education because of illness of their child.","time_frame":"Four years","description":"Self-report measure (online parental questionnaire). Labour participation is combined with parental sick leave rates to determine productivity losses from work."},{"outcome_type":"secondary","measure":"Child health-related quality of life","time_frame":"Four years","description":"Examined with the validated EuroQol 5-Dimensions Youth version questionnaire (EQ-5D-Y) and the proxy version for parents. Child-specific HR-QoL is measured by the validated Paediatric Quality of Life Inventory (PedsQL) and parents complete the proxy version of this questionnaire."},{"outcome_type":"secondary","measure":"Child psychological attributes","time_frame":"Four years","description":"Assessed using the Strength and Difficulties Questionnaire."},{"outcome_type":"secondary","measure":"Child social, emotional, and academic self-efficacy.","time_frame":"Four years","description":"Tested using the Self-Efficacy Questionnaire for Children (SEQ-C)."},{"outcome_type":"secondary","measure":"Child self-confidence, social skills, self-efficacy, school well-being, and social support","time_frame":"Four years","description":"Assessed with OnderwijsMonitor Limburg programme"},{"outcome_type":"secondary","measure":"Child physical activity and sedentary behavior (Actigraph accelerometer)","time_frame":"Four years","description":"In the week in which the child is wearing the accelerometer, parents fill in a short activity diary on their child's physical activity and swimming behaviour and exceptional circumstances (e.g., illness of the child)"},{"outcome_type":"secondary","measure":"Sports club membership, active forms of transport to school, and leisure time physical activities assessed in both children and parents.","time_frame":"Four years","description":"Self-report measure"},{"outcome_type":"secondary","measure":"Child food intake","time_frame":"Four years","description":"Assessed using a food frequency questionnaire and a dietary recall tool to be completed by both children and parents."},{"outcome_type":"secondary","measure":"Child food preferences and familiarity with healthy food products.","time_frame":"Four years","description":"Self-report measure: The questions mainly consist of pictures of food items, for which children can indicate whether they have ever eaten these items and whether they like them or not."},{"outcome_type":"secondary","measure":"Parental practices regarding nutrition and physical activity","time_frame":"Four years","description":"Self-report measure"},{"outcome_type":"secondary","measure":"Parental wellbeing","time_frame":"Four years","description":"measured by the Satisfaction With Life Survey (SWLS)"},{"outcome_type":"secondary","measure":"Parental health-related quality of life","time_frame":"Four years","description":"Measured with the EuroQol - 5-Dimensions Questionnaire (EQ-5D)"},{"outcome_type":"secondary","measure":"Socioeconomic status","time_frame":"Four years","description":"Self-report measure"},{"outcome_type":"secondary","measure":"School/ teacher practices regarding nutrition and physical activity","time_frame":"Four years","description":"E.g. modelling eating healthy food products and encouraging children's physical activity. Measured using adapted version of the Parental Practices Instrument"},{"outcome_type":"secondary","measure":"Teacher's self-reported height, weight and transport forms to work","time_frame":"Four years","description":"Written questionnaire"},{"outcome_type":"secondary","measure":"Child academic achievements","time_frame":"Four years","description":"Monitored using the Dutch national test called Centrale Eindtoets Basisonderwijs (CITO), and various other tests used by the schools. The CITO test measures language, maths and world orientation. In addition to the CITO test, many schools use a wide range of tests throughout the children's school careers. This also includes tests on maths (taken twice a year) and various aspects of language such as decoding skills, spelling, vocabulary, and reading comprehension."},{"outcome_type":"secondary","measure":"School advice and the actual level of secondary school opted for (Dutch secondary education is hierarchically ordered).","time_frame":"Four years","description":"School registration system"},{"outcome_type":"secondary","measure":"School absenteeism and repeating classes","time_frame":"Four years","description":"School registration system"},{"outcome_type":"secondary","measure":"Process evaluation using a school satisfaction questionnaire","time_frame":"Four years","description":"Self-report measure: general parental satisfaction with their children's school (including safety, communication, quality of education, challenges to children, and professionalism of teachers). Implementation of the intervention is evaluated by qualitative outcome measures such as interviews with parents and children, and classroom observations."},{"outcome_type":"secondary","measure":"Juridical evaluation through literature study and interviews","time_frame":"Four years","description":"Legal aspects will be addressed by a thorough scientific literature study and examination of policy and legislation instruments and case-law on the scope of children's right to health. Interviews with the parties involved in the healthy school setting will determine the juridical-related interests and possibilities."}]}
{"nct_id":"NCT02484105","start_date":"2015-09-30","phase":"Phase 4","enrollment":62,"brief_title":"Comforting Conversation During Colonoscopy: A Trial on Patient Satisfaction","official_title":"Comforting Conversation During Colonoscopy: A Randomised Controlled Trial on Patient Satisfaction","primary_completion_date":"2016-01-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2016-01-31","last_update":"2015-09-29","description":"Does comforting conversation during colonoscopy improve on patient satisfaction, compliance and pain management.","other_id":"H-15001924","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age 18-85\r\n\r\n          -  Colonoscopy\r\n\r\n          -  Written informed content\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  ASA Class 4 or higher\r\n\r\n          -  BMI 40 or higher\r\n\r\n          -  Analgesics taken prior to procedure\r\n\r\n          -  Pregnancy or breast feeding\r\n\r\n          -  Allergy to Fentanyl/Midazolam\r\n\r\n          -  Daily consumption of opioids\r\n\r\n          -  Unable to complete questionnaire\r\n      ","sponsor":"Jeppe Thue Jensen","sponsor_type":"Other","conditions":"Colonoscopy","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Comforting Conversation","description":"Pain management, distraction, diversion, empathy. Dependent on qualitative study results."},{"intervention_type":"Behavioral","name":"Behavioral: Standard Communication","description":"Information on procedure type, duration, findings, key landmarks, possibility of analgesic treatment, pause in procedure."}],"outcomes":[{"outcome_type":"primary","measure":"Patient Satisfaction","time_frame":"on average 20 minutes after completed colonoscopy.","description":"Questionnaire with 5 point Likert like scale"},{"outcome_type":"secondary","measure":"Per-procedural Pain management","time_frame":"From inclusion to completed procedure. On average 45 minutes from first to last measurement.","description":"Pain/discomfort prior to-, every 5. minutes and post-procedure with patients using the Visual Analogue Scale"}]}
{"nct_id":"NCT02338882","start_date":"2015-09-30","phase":"Phase 4","enrollment":100,"brief_title":"Clinical Investigation of the Bi Flex M Multifocal IOL","official_title":"Randomised Clinical Investigation of the Bi Flex M Multifocal Intraocular Lens","primary_completion_date":"2018-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-05-31","last_update":"2019-09-24","description":"During cataract surgery an artificial lens is implanted in the eye. These artificial lenses are called intraocular lenses (IOLs) and there are many different types of IOL designs. IOLs are of fixed focus and so unless a multifocal IOL is used you would need to wear spectacles for viewing near objects. This study has been designed to look at how well a multifocal IOL corrects distance and near vision in comparison with a conventional monofocal IOL. Both types of IOLs are commercially available and are commonly implanted. Using new non-invasive methods we hope to be able to better judge the visual performance of these IOLs. In addition the study will involve imaging and examining the IOLs to determine the prevalence of any post-operative complications.","other_id":"MC001","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age related cataract patients requiring cataract surgery with phacoemulsification.\r\n\r\n          -  Patients requiring primary IOL implantation\r\n\r\n          -  Patients with a potential corrected visual acuity of 20/40 or better on clinical\r\n             assessment\r\n\r\n          -  Patients with normal anterior segments apart from cataracts\r\n\r\n          -  Subjects with clear intraocular media other than cataract\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Preexisting pathology or physiology, which may be aggravated by the implant, or may\r\n             render the implant ineffective and that could potentially cause future acuity losses\r\n             to a level of 0.5 or 20/40 or worse in either eye. This includes the following:\r\n\r\n          -  Microphthalmia\r\n\r\n          -  Corneal decompensation or Endothelial Insufficiency\r\n\r\n          -  Pseudo exfoliation\r\n\r\n          -  High myopia\r\n\r\n          -  Pars planitis\r\n\r\n          -  Patient with greater than 1 dioptre of preoperative corneal astigmatism\r\n\r\n          -  Subjects who are expected to require retinal laser treatment\r\n\r\n          -  Previous intraocular and/or corneal surgery\r\n\r\n          -  History of uveitis, glaucoma, proliferative diabetic retinopathy, pseudoexfoliation,\r\n             macular degeneration that may affect potential best corrected visual acuity of 20/40\r\n             or better\r\n\r\n          -  Operative complications of posterior capsular rupture, zonular dehiscence, incomplete\r\n             continuous curvilinear capsulorhexis, severe iris /corneal trauma and inability to\r\n             achieve secure placement in the designated location\r\n\r\n          -  Subjects using a systemic medication that is known to cause ocular side effects\r\n\r\n          -  Subjects participating in a concurrent clinical trial or if they have participated in\r\n             an ophthalmology clinical trial within the last 30 days\r\n\r\n          -  Subjects who have only one eye with potentially good vision\r\n\r\n          -  Patients who are not willing to cooperate for the follow up period\r\n\r\n          -  Visual eccentricity of greater than 0.7mm\r\n\r\n          -  Pregnant women\r\n\r\n          -  Patients where it is not possible to take informed consent\r\n      ","sponsor":"Dr Phillip J Buckhurst","sponsor_type":"Other","conditions":"Cataract","interventions":[{"intervention_type":"Device","name":"Device: Bi flex M multifocal intraocular lens","description":"Multifocal intraocular lens"},{"intervention_type":"Device","name":"Device: Bi flex 1.8 monofocal intraocular lens","description":"Standard monofocal intraocular lens"}],"outcomes":[{"outcome_type":"primary","measure":"Long Term Binocular Visual Acuity (VA)","time_frame":"Visit 2 [12-18 months]","description":"Binocular Visual acuity at 12-18 months assessed at distance intermediate and near both corrected and uncorrected. Assessed in LogMAR"},{"outcome_type":"primary","measure":"Binocular Visual Acuity (VA)","time_frame":"Visit 1 [3-6 months]","description":"Binocular Visual acuity at 3-6 months assessed at distance intermediate and near both corrected and uncorrected. Assessed in LogMAR"},{"outcome_type":"primary","measure":"Monocular Visual Acuity (VA)","time_frame":"Visit 1 [3-6 months]","description":"Monocular Visual acuity at 3-6 months assessed at distance intermediate and near both corrected and uncorrected. Assessed in LogMAR"},{"outcome_type":"primary","measure":"Long Term Monocular Visual Acuity (VA)","time_frame":"Visit 2 [12-18 months]","description":"Monocular Visual acuity at 12-18 months assessed at distance intermediate and near both corrected and uncorrected. Assessed in LogMAR"},{"outcome_type":"primary","measure":"Defocus Curve Profiles","time_frame":"visit 1 (3-6 months)","description":"Visual acuity measurement (assessed in LogMAR) taken with differing levels of optical defocus"},{"outcome_type":"primary","measure":"Long Term Defocus Curve Profiles","time_frame":"visit 2 (12-18 months)","description":"Assessed as a dioptric range and using the Defocus area metric"},{"outcome_type":"secondary","measure":"Long Term Monocular Pelli-Robson Contrast Sensitivity (CS)","time_frame":"Visit 2 [12-18 months]","description":"MonocularContrast sensitivity assessed as a contrast threshold using the Pelli-Robson test"},{"outcome_type":"secondary","measure":"Long Term Binocular Pelli-Robson Contrast Sensitivity (CS)","time_frame":"Visit 2 [12-18 month]","description":"Binocular Contrast sensitivity assessed as a contrast threshold using the Pelli-Robson test"},{"outcome_type":"secondary","measure":"Pelli-Robson Monocular Contrast Sensitivity","time_frame":"Visit 1 [3-6 months]","description":"Monocular Contrast sensitivity assessed as a contrast threshold using the Pelli-Robson test"},{"outcome_type":"secondary","measure":"Pelli-Robson Binocular Contrast Sensitivity","time_frame":"Visit 1 [3-6 months]","description":"Contrast sensitivity assessed as a contrast threshold using the Pelli-Robson test"},{"outcome_type":"secondary","measure":"Long Term Contrast Sensitivity CSV-1000","time_frame":"Visit 2 [12-18 months]","description":"Binocular Assessment of Contrast Sensitivity at threshold using the Contrast sensitivity vision(CSV) CSV-1000"},{"outcome_type":"secondary","measure":"Contrast Sensitivity CSV-1000","time_frame":"Visit 1 [3-6 months]","description":"Binocular Assessment of Contrast Sensitivity at threshold using the CSV-1000"},{"outcome_type":"secondary","measure":"Long Term Reading Performance","time_frame":"Visit 2 (12-18 months)","description":"Assessed as the critical print size and using the reading performance index. Uses Radner reading chart and logarithmic Radner scale (LogRAD) Lower LogRAD equals smaller print size"},{"outcome_type":"secondary","measure":"Reading Performance","time_frame":"visit 1 (3-6 months)","description":"Assessed as the critical print size and using the reading performance index Logarithmic Radner scale (LogRAD) Lower LogRAD equals small print size"},{"outcome_type":"secondary","measure":"Long Term Glare","time_frame":"Visit 2 (12-18 months)","description":"Assessed as the glare area size Scale 0 to 100 Higher scores = larger glare area =worse outcome"},{"outcome_type":"secondary","measure":"Glare","time_frame":"visit 1 (3-6 months)","description":"Assessed as the glare area size Scale 0 to 100 Higher score = larger area = worse outcome"}]}
{"nct_id":"NCT02622490","start_date":"2015-09-30","phase":"N/A","enrollment":28,"brief_title":"Acute Effects of Different Macronutrient Compositions and Meal Distributions of the Food","official_title":"Diet-induced Thermogenesis 2","primary_completion_date":"2020-05-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2020-05-31","last_update":"2019-04-24","description":"About thirty participants, of varying degrees of obesity or being non-obese, without serious concomitant diseases consume either a high- or a low- carbohydrate beverage. The beverage is also consumed either as one single drink or as 5 small portions in the morning and are tested for effects on major cardiovascular risk markers and on metabolic rate for three hours on each occasion.","other_id":"DIT2","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy participants > 18 years with or without obesity\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Major illnesses,\r\n\r\n          -  thyroid diseases,\r\n\r\n          -  need to take prednisolone,\r\n\r\n          -  psychiatric disease,\r\n\r\n          -  inability to understand Swedish\r\n      ","sponsor":"University Hospital, Linkoeping","sponsor_type":"Other","conditions":"Metabolic Rate|Plasma Glucose|Serum Insulin|Serum Triglycerides|Sense of Satiety","interventions":[{"intervention_type":"Other","name":"Other: two test meals with two different macronutrient compositions","description":"Either a high or a low carb meal either as one large or as 5 small meals. ie a crossover trial with one arm"}],"outcomes":[{"outcome_type":"primary","measure":"Metabolic rate","time_frame":"During about 3 hours","description":"The metabolic rate is measured before (baseline) and there after repeatedly during 3 hours"},{"outcome_type":"secondary","measure":"Effects on glucose and insulin","time_frame":"3 hours","description":"Repeated test of glucose and insulin for three hours after test meal"}]}
{"nct_id":"NCT02864797","start_date":"2015-09-29","phase":"N/A","enrollment":116,"brief_title":"Feasibility Study of a Prospective and Pragmatic Cohort","official_title":"Health Related Quality of Life of Patients With Gynecologic Cancers: Feasibility Study of a Prospective and Pragmatic Cohort","primary_completion_date":"2018-08-22","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2018-08-22","last_update":"2017-10-13","description":"Gynecologic cancers (cancers of cervix, endometrium, ovary, vagina, and vulva) represent an important part of the female cancer in France with more than 15 000 new cases in 2012. As considerable progress have been made in diagnostic and therapeutic strategies, an important part of the gynecologic cancers are diagnosed at an early stage and globally, the after treatment overall survival rate is estimated to more than 80% at five years. Thus, it is of evident interest to study health related Quality of Life (QoL) among these patients who will continue to live after their cancer and to consider QoL as a primary end-point, beyond overall survival. The GYNEQOL (health related Quality Of Life of women with GYNEcologic cancer) group is a working group initiated in Besanon and whose goal is to investigate QoL of gynecologic cancers' patients. It gathers several entities from the hospital of Besanon, namely the Methodology and Quality of Life in Oncology Unit, the Gynecologic Unit and the Oncology Unit. The GYNEQOL study is a project of a prospective cohort study, in a pragmatic clinical practice, with the main objective of longitudinally collecting and analyzing QoL data of these women. The pilot phase, GYNEQOL-Pilot, restricted to the hospital of Besanon, has started in September 2015 with the goal of assessing the feasibility of the cohort. The feature of this study is that patients answer to QoL questionnaires using tablets computer and the Computer-based Health Evaluation System software (CHES). Indeed, use of electronic solutions to collect patient reported outcomes is drastically increasing those last years. It has been underlined that routinely collecting symptoms could increase both QoL and survival among cancer patients. It enables to use these data in real-time in routine practice by presenting QoL scores to physicians in simple graphical histograms for both transversal and longitudinal measurements and it ensures a reliable data collection.","other_id":"P/2014/238","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  patient with newly diagnosed gynecologic cancer (ovaries, endometrium, cervix, vagina,\r\n             vulva, fallopian tube), whatever the stage and histological type.\r\n\r\n          -  patient treated at Besanon University Hospital\r\n\r\n          -  patient aged of 18 years old or older\r\n\r\n          -  patient who do understand French\r\n\r\n          -  patient without any major cognitive impairment\r\n\r\n          -  patient who hav signed the informed consent\r\n\r\n          -  patient affiliated to the French social insurance\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  patient with recurrent cancer\r\n\r\n          -  patient with legal incapacity or limited legal capacity\r\n\r\n          -  patient without any social insurance\r\n\r\n          -  patient unlikely to cooperate\r\n      ","sponsor":"Centre Hospitalier Universitaire de Besancon","sponsor_type":"Other","conditions":"Gynecologic Cancers","interventions":[{"intervention_type":"Other","name":"Other: Health related quality of life collected via CHES","description":"Health related quality of life (QoL) is collected at each follow-up visit using tablets computer and CHES software. Thus, QoL's results are directly presented to clinicians via the CHES, in order to be considered as part of the supportive care strategy at the end of the study"}],"outcomes":[{"outcome_type":"primary","measure":"Health related quality of life (QoL)","time_frame":"month 18","description":"The primary endpoint will be QoL assessed by the EORTC QLQ-C30, for the following targeted dimensions : global health, emotional, social and functional roles and fatigue"},{"outcome_type":"secondary","measure":"Participation rate","time_frame":"at the last inclusion, up to 12 months","description":"the rate of number of included patients on number of eligible patients"},{"outcome_type":"secondary","measure":"acceptability of the use of the CHES and tablets computer","time_frame":"at study completion, up to 24 months","description":"How did patients perceived the use of tablets computer and CHES software, qualitative assessment by the clinical research associates"},{"outcome_type":"secondary","measure":"frequency of use of the QoL results by the physicians","time_frame":"at study completion, up to 24 months","description":"how many times physicians used the CHES in their clinical practice."},{"outcome_type":"secondary","measure":"occurence and type of missing data","time_frame":"at study completion, up to 24 months","description":"count of QoL missing data at each time point"},{"outcome_type":"secondary","measure":"attrition","time_frame":"at study completion, up to 24 months","description":"count of patients lost of follow up at study completion"}]}
{"nct_id":"NCT02477696","start_date":"2015-09-17","phase":"Phase 3","enrollment":533,"brief_title":"Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Subjects With High Risk CLL","official_title":"A Randomized, Multicenter, Open-Label, Non-Inferiority, Phase III Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Subjects With High Risk Chronic Lymphocytic Leukemia","primary_completion_date":"2020-09-15","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2021-11-01","last_update":"2021-08-30","description":"This study is designed to evaluate PFS endpoint for acalabrutinib vs ibrutinib in previously treated chronic lymphocytic leukemia.","other_id":"ACE-CL-006","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Men and women  18 years of age.\r\n\r\n          -  ECOG performance status of 0 to 2.\r\n\r\n          -  Diagnosis of CLL.\r\n\r\n          -  Must have  1 of the following high-risk prognostic factors:\r\n\r\n               -  Presence of 17p del by central laboratory.\r\n\r\n               -  Presence of 11q del by central laboratory.\r\n\r\n          -  Active disease meeting  1 of the following IWCLL 2008 criteria for requiring\r\n             treatment\r\n\r\n          -  Must have received  1 prior therapies for CLL.\r\n\r\n          -  Meet the following laboratory parameters:\r\n\r\n               -  ANC  750 cells/L or  500 cells/L in subjects with documented bone marrow\r\n                  involvement, and independent of growth factor support 7 days before assessment.\r\n\r\n               -  Platelet count  30,000 cells/L without transfusion support 7 days before\r\n                  assessment. Subjects with transfusion-dependent thrombocytopenia are excluded.\r\n\r\n               -  Serum AST/SGOT and ALT/SGPT  3.0 x ULN.\r\n\r\n               -  Total bilirubin  1.5 x ULN.\r\n\r\n               -  Estimated creatinine clearance  30 mL/min.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Known CNS lymphoma or leukemia.\r\n\r\n          -  Known prolymphocytic leukemia or history of, or currently suspected, Richter's\r\n             syndrome.\r\n\r\n          -  Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura.\r\n\r\n          -  Prior exposure to ibrutinib or to a BCR inhibitor or a BCL-2 inhibitor.\r\n\r\n          -  Received any chemotherapy, external beam radiation therapy, anticancer antibodies, or\r\n             investigational drug within 30 days before first dose of study drug.\r\n\r\n          -  Prior radio- or toxin-conjugated antibody therapy.\r\n\r\n          -  Prior allogeneic stem cell or autologous transplant.\r\n\r\n          -  Major surgery within 4 weeks before first dose of study drug.\r\n\r\n          -  Prior malignancy, except for adequately treated lentigo maligna melanoma,\r\n             non-melanomatous skin cancer, in situ cervical carcinoma or other malignancy treated\r\n             with no evidence of active disease > 3 years before Screening and at low risk for\r\n             recurrence.\r\n\r\n          -  Significant cardiovascular disease within 6 months of screening.\r\n\r\n          -  Known history of infection with HIV.\r\n\r\n          -  History of stroke or intracranial hemorrhage within 6 months before randomization.\r\n\r\n          -  History of bleeding diathesis.\r\n\r\n          -  Requires or receiving anticoagulation with warfarin or equivalent vitamin K\r\n             antagonists within 7 days of first dose of study drug.\r\n\r\n          -  Requires treatment with a strong CYP3A inhibitor/inducer.\r\n      ","sponsor":"Acerta Pharma BV","sponsor_type":"Industry","conditions":"Chronic Lymphocytic Leukemia","interventions":[{"intervention_type":"Drug","name":"Drug: ACP-196","description":"acalabrutinib 100 mg BID (Arm A; N=250)"},{"intervention_type":"Drug","name":"Drug: ibrutinib","description":"ibrutinib 420 mg QD (Arm B; N=250)"}],"outcomes":[{"outcome_type":"primary","measure":"Progression-free survival in Arm A compared to Arm B","time_frame":"36 months"},{"outcome_type":"secondary","measure":"Incidence of treatment-emergent Grade ≥ 3 infections in Arm A versus Arm B","time_frame":"36 months"},{"outcome_type":"secondary","measure":"Incidence of Richter's transformation in Arm A versus Arm B","time_frame":"36 months"},{"outcome_type":"secondary","measure":"Incidence of Atrial fibrillation in Arm A versus Arm B","time_frame":"36 months"},{"outcome_type":"secondary","measure":"Overall survival in Arm A versus Arm B","time_frame":"36 months"}]}
{"nct_id":"NCT02534909","start_date":"2015-09-09","phase":"Phase 2","enrollment":10,"brief_title":"Proof of Concept Study to Assess the Efficacy, Safety and Pharmacokinetics of LFG316 in Patients With Paroxysmal Nocturnal Hemoglobinuria","official_title":"An Open-label Proof of Concept Study to Assess the Efficacy, Safety and Pharmacokinetics of LFG316, an Anti-C5 Monoclonal Antibody in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)","primary_completion_date":"2022-02-25","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2022-02-25","last_update":"2021-05-17","description":"To determine whether LFG316 can induce a hematological response, as measured by reduction in hemolytic activity, in patients with PNH.","other_id":"CLFG316X2201","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male and female patients between the age of 18-75 (inclusive), or 18-65 (applicable in\r\n             Czech Republic) with a diagnosis of PNH prior to screening\r\n\r\n          -  A documented PNH clone size of 10% by RBCs and/or granulocytes\r\n\r\n          -  Serum LDH levels at least 1.5-fold above the upper limit of normal (ULN) at screening\r\n\r\n          -  Negative pregnancy test for women of child bearing potential at screening\r\n\r\n          -  Previous vaccination against Neisseria meningitidis is required at least 2 weeks prior\r\n             to first dosing.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Known or suspected hereditary complement deficiency\r\n\r\n          -  History of recurrent meningitis, history of meningococcal meningitis despite\r\n             vaccination\r\n\r\n          -  Presence or suspicion (based on judgment of the investigator) of active bacterial\r\n             infection within 2 weeks prior to first dose of LFG316, or recurrent bacterial\r\n             infections\r\n\r\n          -  Under active therapy with other agents interfering with the complement system\r\n\r\n          -  Severe concurrent co-morbidities that are a likely caused by underlying autoimmune\r\n             diseases other than PNH\r\n\r\n          -  Women of child-bearing potential, unless they are using highly effective methods of\r\n             contraception during dosing and for 50 days after the last dose of LFG316.\r\n      ","sponsor":"Novartis Pharmaceuticals","sponsor_type":"Industry","conditions":"Paroxysmal Nocturnal Hemoglobinuria PNH","interventions":[{"intervention_type":"Biological","name":"Biological: LFG316","description":"LFG316 will be administered to all patients enrolled in the study"}],"outcomes":[{"outcome_type":"secondary","measure":"Area Under the Curve (AUC) - Pharmacokinetics parameter","time_frame":"320 weeks: screening visit, weekly visits for 4 weeks, and every 4 weeks from week 4 to week 54, visit on weeks 80, 106 132, 158, 184 and EOS)","description":"Blood draw for pharmacokinetics evaluation"},{"outcome_type":"secondary","measure":"Maximum Plasma Concentration (Cmax) - Pharmacokinetics parameter","time_frame":"320 weeks: screening visit, weekly visits for 4 weeks, and every 4 weeks from week 4 to week 54, visit on weeks 80, 106 132, 158, 184 and EOS)","description":"Blood draw for pharmacokinetics evaluation"},{"outcome_type":"secondary","measure":"Time to Maximum Concentration (Tmax) - Pharmacokinetics parameter","time_frame":"320 weeks: screening visit, weekly visits for 4 weeks, and every 4 weeks from week 4 to week 54, visit on weeks 80, 106 132, 158, 184 and EOS)","description":"Blood draw for pharmacokinetics evaluation"},{"outcome_type":"primary","measure":"Serum lactate dehydrogenase (LDH) levels","time_frame":"Screening, weekly for 4 weeks, and every 2 weeks from week 4 to week 208, every 8 weeks from week 210 to 312, follow-up and EoS","description":"Changes in serum lactate dehydrogenase (LDH) levels"},{"outcome_type":"secondary","measure":"Adverse Events (AEs) and Serious Adverse Events (SAEs)","time_frame":"Participants will be monitored for AEs and SAEs for the whole duration of the study (i.e. up to 320 weeks after the first treatment)","description":"Including any clinically relevant findings related with ECG, vital signs, laboratory data"}]}
{"nct_id":"NCT03932929","start_date":"2015-09-02","phase":"N/A","enrollment":35,"brief_title":"36-Month Clinical Evaluation of a Universal Adhesive","official_title":"36-Month Clinical Evaluation of Different Adhesive Strategies of a Universal Adhesive","primary_completion_date":"2018-09-02","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-09-02","last_update":"2019-05-06","description":"The aim of this clinical trial was to evaluate and compare the performance of a universal adhesive with different adhesive strategies in the restoration of non-carious cervical lesions (NCCLs) over a 36-month period.","other_id":"KA-17088","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":81,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  over 18 years old\r\n\r\n          -  good oral hygiene\r\n\r\n          -  available for recall\r\n\r\n          -  at least 20 teeth under occlusion\r\n\r\n          -  the presence of at least three non-carious cervical lesions\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  poor oral hygiene\r\n\r\n          -  bruxism habits\r\n\r\n          -  severe or chronic periodontitis\r\n\r\n          -  If the teeth selected for study, were nonvital, or had any restorations on other\r\n             surfaces were not included.\r\n      ","sponsor":"Hacettepe University","sponsor_type":"Other","conditions":"Non-Carious Cervical Lesions","interventions":[{"intervention_type":"Device","name":"Device: Scotchbond Universal Adhesive (3M ESPE)","description":"Adhesive system"}],"outcomes":[{"outcome_type":"primary","measure":"Marginal adaptation","time_frame":"From baseline to 36 month","description":"Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal adaptation. Marginal adaptation was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed . Scores; Alfa: Closely adapted, no visible crevice. Bravo: Visible crevice, explorer will penetrate. Charlie: Crevice in which dentin is exposed"},{"outcome_type":"primary","measure":"Marginal staining","time_frame":"From baseline to 36 month","description":"Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal staining. Marginal staining was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed . Scores: Alfa: No discoloration. Bravo: Discoloration without. Charlie: Discoloration with penetration in pulpal direction"},{"outcome_type":"primary","measure":"Retention","time_frame":"From baseline to 36 month","description":"Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by 2 independent clinicians. Scores: Alfa: No loss of restorative material. Charlie: Any loss of restorative material"},{"outcome_type":"primary","measure":"Postoperative sensitivity","time_frame":"From baseline to 36 month","description":"Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by 2 independent clinicians. Scores: Alfa: Not present. Bravo: sensitive but diminishing in intensity. Charlie:constant sensitivity, not diminishing in intensity"},{"outcome_type":"primary","measure":"Seconder caries","time_frame":"From baseline to 36 month","description":"Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by 2 independent clinicians. Scores: Alfa: No caries present. Charlie: Caries present"}]}
{"nct_id":"NCT02551783","start_date":"2015-09-01","phase":"N/A","enrollment":150,"brief_title":"Dorsal vs. Ventral Buccal Graft Dorsal vs. Ventral Buccal Graft","official_title":"A Randomized Study of Dorsal Versus Ventral Buccal Mucosa Graft Onlay for Bulbar Urethroplasty","primary_completion_date":"2019-03-01","study_type":"Interventional","rec_status":"Terminated","completion_date":"2019-03-01","last_update":"2019-11-01","description":"This is a randomized non-blinded comparison of dorsal vs. ventral approach for buccal mucosa graft urethroplasty in the bulbar urethra. Buccal mucosa graft is a common method of repairing the strictured urethra. Current evidence suggests the two approaches for placement of the graft are equally successful at correcting the stricture and the two approaches have similar risks of complications. The investigators propose to randomly assign appropriately selected patients to either a dorsally- or ventrally-placed graft. No additional procedures beyond the normal care protocol will be required of the patients. Success will be assessed via objective and subjective methods; complications will be tallied in a standardized fashion. Outcomes will be measured at two years.","other_id":"1508M77183","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Strictures must predominantly include the proximal and/or mid bulbar urethra and be\r\n             otherwise amenable to buccal graft onlay urethroplasty\r\n\r\n          -  Strictures may extend from the mid-bulbar urethra up to the distal bulbar urethra\r\n             within the scrotum, but not through the scrotum to the pendulous junction\r\n\r\n          -  Subjects able to consent for themselves\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  prior open urethral surgery, such as prior urethroplasty, artificial urinary sphincter\r\n             placement, male urethral sling placement, and rectourethral fistula\r\n\r\n          -  radiation therapy to the pelvis\r\n\r\n          -  previous hypospadias repair\r\n\r\n          -  lichen sclerosis unable to consent for themselves\r\n      ","sponsor":"University of Minnesota","sponsor_type":"Other","conditions":"Urethral Stricture","interventions":[{"intervention_type":"Procedure","name":"Procedure: Urethroplasty with buccal mucosa graft","description":"A surgery to correct urethral stricture"},{"intervention_type":"Procedure","name":"Procedure: Ventral Buccal","description":"Urethroplasty with buccal graft. In this arm the graft is placed on the ventral wall of the urethra."}],"outcomes":[{"outcome_type":"primary","measure":"Cumulative Incidence of anatomic recurrence determined by cystoscopy","time_frame":"1 year","description":"Anatomic evidence of recurrence based on surveillance cystoscopy (i.e., if the 16F flexible cystoscope cannot bypass the surgical site then there is a failure). Flexible cystoscopy will be performed at 3 and 12 months after surgery. All surgeons will use a standard-sized scope. This will be a bivariate outcome (scope is able to pass without trauma vs. unable to pass or only able to pass with trauma)"},{"outcome_type":"secondary","measure":"Cumulative Incidence of Complications deep venous incision and drainage","time_frame":"2 years","description":"A composite outcome of the following rare peri-operative complications: deep venous thrombosis, positioning complaints (numbness in the feet), perineal abscess (requiring incision and drainage) and leakage of dye from the urethra on post-op voiding cystourethrogram. Each of these complications is expected to occur in about 1% of subjects. Therefore no standardized assessment will be performed: we will not perform screening ultrasound for DVT, nor will we give every patient a standardized questionnaire to assess for foot numbness. Rather, at each clinical visit, the physician will note whether the findings are present or absent based on physical exam, subjective complaints or objective tests."},{"outcome_type":"other","measure":"Cumulative Incidence of Secondary Procedures to Treat Stricture Recurrence restenosis","time_frame":"2 years","description":"Occurrence of any urethral intervention for restenosis including including urethral dilation, internal urethrotomy, repeat urethroplasty, or suprapubic catheter placement."},{"outcome_type":"other","measure":"Urinary Symptoms","time_frame":"2 years","description":"A Patient Reported Outcome Measure (PROM) that has been validated for assessment of urinary symptoms characteristic or urethral stricture disease will be completed by patients pre-operatively and at 3, 12 and 24 months post-operatively. This asks questions about urinary hesitancy, straining, interrupted urinary stream, incomplete emptying, and post-void dribbling. Score range from 0-20 plus 2 qualitative answers. We will compare pre- and post-op as well as between dorsal and ventral graft."},{"outcome_type":"other","measure":"Symptoms, Other pain in the penis and leakage of urine.","time_frame":"2 years","description":"A Patient Reported Outcome Measure (PROM) that has been validated for assessment of adverse effects after urethroplasty or due to stricture itself including pain in the bladder, pain in the penis and leakage of urine. Each outcome is scored 0-3 and the outcomes are not summed. Will be completed by patients pre-operatively and at 3, 12 and 24 months post-operatively. We will compare pre- and post-op as well as between dorsal and ventral graft."},{"outcome_type":"other","measure":"Health Status overall functioning and self-cares","time_frame":"2 years","description":"A Patient Reported Outcome Measure (PROM) that has been validated for assessment of overall functioning and self-cares. Contains 5 questions about mobility, self-care, usual activities, pain, and anxiety/depression. There is no scoring system. Answers are not summed but are reported individually. Will be completed by patients pre-operatively and at 3, 12 and 24 months post-operatively. Will be completed by patients pre-operatively and at 3, 12 and 24 months post-operatively. We will compare pre- and post-op as well as between dorsal and ventral graft."},{"outcome_type":"other","measure":"Evaluation of Urinary Flow","time_frame":"2 years","description":"A Patient Reported Outcome Measure (PROM) that has been validated for assessment of urinary strength of stream in men with urethral stricture disease. This consists of a picture of the steam coming from a silhouette of a man with numbers 1-4 assigned to the stream based on how far the stream travels. Will be completed by patients pre-operatively and at 3, 12 and 24 months post-operatively. We will compare pre- and post-op as well as between dorsal and ventral graft."},{"outcome_type":"other","measure":"Overall Health Likert scale scoring from 0-100","time_frame":"2 years","description":"A Likert scale scoring from 0-100 for overall health. Will be completed by patients pre-operatively and at 3, 12 and 24 months post-operatively. We will compare pre- and post-op as well as between dorsal and ventral graft."},{"outcome_type":"other","measure":"Male Sexual Health Questionnaire","time_frame":"2 years","description":"A PROM validated for the assessment of ejaculatory dysfunction. Has been studied some in urethroplasty patients. 4 questions with scores 0-5 are summed for a total score of 0-20. Will be completed by patients pre-operatively and at 3, 12 and 24 months post-operatively. We will compare pre- and post-op as well as between dorsal and ventral graft."},{"outcome_type":"other","measure":"Sexual Health Inventory for Men erectile dysfunction","time_frame":"2 years","description":"A PROM validated for the assessment of erectile dysfunction. Has been studied some in urethroplasty patients. 5 questions with scores 1-5 are summed for a total score of 5-25. Will be completed by patients pre-operatively and at 3, 12 and 24 months post-operatively. We will compare pre- and post-op as well as between dorsal and ventral graft."},{"outcome_type":"other","measure":"Urinary Flow Rate","time_frame":"2 years","description":"Patient urinates into a receptacle that measures the speed of his urination. Reported as maximum and mean flow rate. Will be completed by patients pre-operatively and at 3, 12 and 24 months post-operatively. We will compare pre- and post-op as well as between dorsal and ventral graft."}]}
{"nct_id":"NCT02467920","start_date":"2015-08-31","phase":"Phase 4","enrollment":349,"brief_title":"Efficacy and Safety of Basal Insulin Glargine Combination With Exenatide Bid vs Aspart30 in T2DM","official_title":"Efficacy and Safety of Basal Insulin Glargine Combination With Exenatide Bid vs Switching Premix Human Insulin to Aspart30 in T2DM With Inadequate Glycaemic Control on Premixed Human Insulin and Metformin: a Randomized, Open, Parallel Trial","primary_completion_date":"2017-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-12-31","last_update":"2018-11-14","description":"Efficacy and Safety of Basal Insulin Glargine Combination with Exenatide bid vs Switching Premix Human Insulin to Aspart30 in T2DM with Inadequate Glycaemic Control on Premixed Human Insulin and Metformin: a Randomized, Open, Parallel trial.","other_id":"ESR-14-10352","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Provision of informed consent\r\n\r\n          -  Type 2 diabetic patients receiving twice-daily premixed human insulin 30 therapy  30\r\n             U/d and metformin with maximum tolerated dosage ( 1500mg/d)\r\n\r\n          -  HbA1c > 8.0 % and < 11.0 % (HbA1c > 7.0 % and < 10.0% at randomization)\r\n\r\n          -  Men and women (non-pregnant and using a medically approved birth-control method) aged\r\n              18 and  70 years\r\n\r\n          -  BMI  23 and  35 kg/m2\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Type 1 diabetes or other specific types of diabetes\r\n\r\n          -  Pregnancy, preparation for pregnancy, lactation and women of child-bearing age\r\n             incapable of effective contraception methods\r\n\r\n          -  Uncooperative subject because of various reasons\r\n\r\n          -  Abnormal liver function, glutamic-pyruvic transaminase (ALT) and glutamic-oxaloacetic\r\n             transaminase (AST) > twice the upper limits of normal\r\n\r\n          -  Impairment of renal function, serum creatinine:  133mmol/L for female 135mmol/L for\r\n             male\r\n\r\n          -  Serious chronic gastrointestinal diseases\r\n\r\n          -  Edema\r\n\r\n          -  Serious heart diseases, such as cardiac insufficiency (level III or more according to\r\n             NYHA), acute coronary syndrome and old myocardial infraction\r\n\r\n          -  Blood pressure: Systolic blood pressure (SBP)  180mmHg and/or diastolic blood\r\n             pressure (DBP)  110mmHg\r\n\r\n          -  White blood count (WBC) < 4.0109/L or platelet count (PLT) < 90109/Lor definite\r\n             anemia (Hb< 120g/L for male, < 110g/L for female), or other hematological diseases\r\n\r\n          -  Endocrine system diseases, such as hyperthyroidism and hypercortisolism\r\n\r\n          -  Experimental drug allergy or frequent hypoglycemia\r\n\r\n          -  Psychiatric disorders, drug or other substance abuse\r\n\r\n          -  Diabetic ketoacidosis and hyperosmolar nonketotic coma requiring insulin therapy\r\n\r\n          -  Stressful situations such as surgery, serious trauma and so on\r\n\r\n          -  Chronic hypoxic diseases such as pulmonary emphysema and pulmonary heart disease\r\n\r\n          -  Combined use of drugs effecting glucose metabolism such as glucocorticoid\r\n\r\n          -  Tumor, especially bladder tumor and/or family history of bladder tumor and/or\r\n             long-term hematuria\r\n      ","sponsor":"Huazhong University of Science and Technology","sponsor_type":"Other","conditions":"Type 2 Diabetes Mellitus","interventions":[{"intervention_type":"Drug","name":"Drug: glargine + exenatide","description":"glargine ( once-daily subcutaneous injection at bedtime) combination with exenatide (subcutaneous injection, twice-daily)"},{"intervention_type":"Drug","name":"Drug: aspart 30","description":"aspart 30 ( subcutaneous injection, twice daily)"}],"outcomes":[{"outcome_type":"secondary","measure":"The incidence and rate of hypoglycaemic events during the study","time_frame":"baseline, 12 weeks and 24 weeks"},{"outcome_type":"primary","measure":"the absolute change in HbA1c from baseline to 24-week endpoint of basal insulin glargine combination with exenatide bid vs. switching to aspart30 in type 2 diabetic patients inadequately controlled on premixed human insulin and metformin.","time_frame":"from baseline to 24-week endpoint"},{"outcome_type":"secondary","measure":"Change in HbA1c from baseline to 12 weeks endpoint","time_frame":"from baseline to 12 weeks endpoint"},{"outcome_type":"secondary","measure":"The percentage of participants who achieved HbA1c ≤ 6.5% and < 7%","time_frame":"12 weeks and 24 weeks"},{"outcome_type":"secondary","measure":"Fasting blood glucose","time_frame":"12 weeks and 24 weeks"},{"outcome_type":"secondary","measure":"Daily insulin use","time_frame":"baseline, 12 weeks and 24 weeks"},{"outcome_type":"secondary","measure":"Change in body weight","time_frame":"from baseline to 12 and 24 weeks"}]}
{"nct_id":"NCT02558413","start_date":"2015-08-31","phase":"Phase 1","enrollment":60,"brief_title":"Phase 1 Safety and Pharmacokinetics Study of Single Ascending Doses of BTA-C585 in Healthy Volunteers","official_title":"A Double-Blind, Placebo-Controlled, Single Ascending Oral Dose Study of the Safety and Pharmacokinetics of BTA-C585 in Healthy Volunteers","primary_completion_date":"2015-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-12-31","last_update":"2018-05-30","description":"This is a placebo-controlled, double-blind, randomized, single dose escalation Phase 1 clinical trial to determine the safety and tolerability of BTA-C585 administered orally to healthy subjects.","other_id":"BTA585-001","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy men and women aged 18-60 years;\r\n\r\n          -  Weight  50 kg and Body Mass Index (BMI) of 19 to 32;\r\n\r\n          -  Female subjects must be of non-childbearing potential;\r\n\r\n          -  Male subjects must agree to use a double barrier method of birth control;\r\n\r\n          -  Able to provide informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Current or recent (within 14 days of Day 0) bacterial or viral infection;\r\n\r\n          -  Positive results for hepatitis B, hepatitis C, or HIV;\r\n\r\n          -  Clinically significant abnormalities noted on ECG;\r\n\r\n          -  Safety laboratory abnormalities;\r\n\r\n          -  Regular use of medications, prescription or non-prescription;\r\n\r\n          -  Poor vein access or fear of venipuncture;\r\n\r\n          -  Major surgery, significant recent injury or trauma within 30 days;\r\n\r\n          -  Received an investigational drug or vaccine within 30 days\r\n      ","sponsor":"Biota Pharmaceuticals, Inc.","sponsor_type":"Industry","conditions":"Pharmacokinetics|Healthy Volunteers","interventions":[{"intervention_type":"Drug","name":"Drug: BTA-C585 oral capsules","description":"BTA-C585; Single ascending doses from 50 mg to 800 mg"},{"intervention_type":"Drug","name":"Drug: BTA-C585 matching placebo","description":"Single ascending doses to match 50 to 800 mg BTA-C585 capsules"}],"outcomes":[{"outcome_type":"primary","measure":"Number of adverse events","time_frame":"Day 0 to Day 11"},{"outcome_type":"primary","measure":"Area under the plasma concentration-time curve (AUC) from time 0 to 24 hours","time_frame":"0-24 hours"}]}
{"nct_id":"NCT02992236","start_date":"2015-08-31","phase":"Phase 1","enrollment":16,"brief_title":"Effects of the NO-synthase Inhibitor VAS203 on Renal Function in Healthy Volunteers","official_title":"Effects of the NO-synthase Inhibitor VAS203 on Renal Function in Healthy Volunteers","primary_completion_date":"2016-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-11-30","last_update":"2019-08-09","description":"Analysis of the effect of the NO-Synthase inhibitor VAS203 (6 hours infusion of 10 mg/kg) on renal function and perfusion in 16 healthy subjects.","other_id":"VAS203/I/3/05","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Other","masking_description":"Quadruple","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Informed consent in writing available.\r\n\r\n          2. Willing and able to comply with all requirements of the study.\r\n\r\n          3. Male, 18 and 45 years (inclusive).\r\n\r\n          4. Subject has a body weight between 60 kg and 100 kg, extremes included.\r\n\r\n          5. BMI 18 to 27 kg/m2.\r\n\r\n          6. Non-smoker\r\n\r\n          7. Serum creatinine within reference range (1.2 mg/dL) and Cockroft-Gault Clearance > 90\r\n             ml/min\r\n\r\n          8. Good general health as judged by the Investigator, as determined by medical history,\r\n             physical examination, vital signs (systolic and diastolic blood pressure and pulse\r\n             rate) and clinical laboratory parameters (clinical chemistry, hematology, and\r\n             urinalysis)\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Clinically significant abnormalities in physical examination, vital signs or clinical\r\n             laboratory parameters (according to the Investigator's judgment).\r\n\r\n          2. Serum glutamate oxaloacetate transaminase or glutamate-pyruvate transaminase > 2-times\r\n             above the upper limit of normal range.\r\n\r\n          3. Subject with Cockcroft-Gault clearance < 90 ml/min.\r\n\r\n          4. Clinically significant history of cardiovascular disease or any known present\r\n             cardiovascular disease.\r\n\r\n          5. History of clinically significant neurological, gastrointestinal, renal, hepatic,\r\n             psychological, pulmonary, metabolic, endocrine, hematological, or other major\r\n             disorders.\r\n\r\n          6. Office blood pressure at screening higher than 160/100 mmHg, or lower than 95/55 mmHg.\r\n\r\n          7. Office heart rate at screening after at least 5 minutes outside the range of 50- 99\r\n             beats per minute (inclusive).\r\n\r\n          8. Concomitant use of OTC medication within 1 week prior to dosing, except use of\r\n             paracetamol (up to 2 g/day).\r\n\r\n          9. Participation in any other clinical study within 30 days prior to inclusion in this -\r\n      ","sponsor":"Vasopharm GmbH","sponsor_type":"Industry","conditions":"Renal Function Impairment in Healthy Volunteers","interventions":[{"intervention_type":"Drug","name":"Drug: VAS203","description":"Infusion of NO-Synthase inhibitor VAS203"},{"intervention_type":"Drug","name":"Drug: Saline","description":"Infusion of saline"}],"outcomes":[{"outcome_type":"primary","measure":"Renal Plasma Flow","time_frame":"0, 2h, 4h, 6h and 8 h after start of infusion","description":"Renal plasma flow measurement by para-Amino-Hippuric-Acid Clearance Method"},{"outcome_type":"primary","measure":"Glomerular Filtration Rate","time_frame":"0, 2h, 4h, 6h and 8 h after start of infusion","description":"by para-Amino-Hippuric Acid Clearance Method"},{"outcome_type":"secondary","measure":"Serum Creatinine Concentration","time_frame":"0, 2h, 4h, 6h, 8h, 10h, 24h and 48h after start of infusion"}]}
{"nct_id":"NCT04540328","start_date":"2015-08-31","phase":"N/A","enrollment":80,"brief_title":"Non-surgical Peridontal Treatment on Cardiovascular Risk Markers","official_title":"Effect of Non-surgical Peridontal Treatment on Cardiovascular Risk Markers in Patients With Severe Chronic Periodontitis","primary_completion_date":"2016-02-29","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-08-31","last_update":"2020-09-07","description":"The study evaluates the influence of non-surgical mechanical periodontal treatment in patients with severe chronic periodontitis on inflammatory markers related to risk for cardiovascular diseases","other_id":"2015 / 029","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":30,"maximum_age":54,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Clinical diagnosis of severe chronic periodontitis\r\n\r\n        Clinical diagnosis of periodontal health\r\n\r\n        Exclusion Criteria:\r\n\r\n        Systemic diseases such as diabetes, cardiovascular disease\r\n\r\n        Periodontal treatment within the previous year\r\n\r\n        Drugs such as systemic steroids, non-steroidal anti-inflammatory drugs, immunosuppressants,\r\n        hormone drugs, contraceptives, anticoagulants, cholesterol regulating drugs, systemic\r\n        antibiotics, antioxidants within the previous 3 months\r\n\r\n        Pregnant or lactating\r\n\r\n        Consumed alcohol\r\n\r\n        Smoker\r\n      ","sponsor":"Krkkale University","sponsor_type":"Other","conditions":"Cardiovascular Risk Markers|Chronic Periodontitis","interventions":[{"intervention_type":"Other","name":"Other: Non-surgical periodontal treatment"}],"outcomes":[{"outcome_type":"primary","measure":"Homocysteine (Hcy)","time_frame":"At the 3rd months after non-surgical periodontal treatment","description":"Serum Concentration (nmol/mL)"},{"outcome_type":"primary","measure":"Asymmetric dimethylarginine (ADMA)","time_frame":"At the 3rd months after non-surgical periodontal treatment","description":"Serum Concentration (pg/mL)"},{"outcome_type":"primary","measure":"Endothelial nitric oxide synthase (eNOS)","time_frame":"At the 3rd months after non-surgical periodontal treatment","description":"Serum Concentration (pg/mL)"},{"outcome_type":"primary","measure":"Monocyte chemoattractant protein-1 (MCP-1)","time_frame":"At the 3rd months after non-surgical periodontal treatment","description":"Serum Concentration (ng/mL)"},{"outcome_type":"secondary","measure":"Clinical periodontal parameter","time_frame":"At the 3rd months after non-surgical periodontal treatment","description":"Clinical attachment level (mm)"}]}
{"nct_id":"NCT02521454","start_date":"2015-08-31","phase":"N/A","enrollment":61,"brief_title":"A Pilot Trial of Mindfulness-Based Resilience Training Among Police Officers","primary_completion_date":"2018-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-07-31","last_update":"2018-08-29","description":"Successful policing requires rapid and unbiased decision-making, well-developed emotion regulation skills, and psychological resilience. However, law enforcement officers (LEOs) are frequently exposed to intensive work-related stress and trauma, and consequently, are at elevated risk of adverse mental health outcomes. These mental health issues in turn are some of the primary mechanisms underlying other- and self-directed violence among LEOs. The excessive use of force by LEOs, including unjustified shootings, frequently captures national headlines and is considered by many to be one of the most serious and divisive human rights issues in the United States. Previous research suggests that LEOs can be impacted by various factors when making rapid decisions while using firearms, including a lack of careful consideration of contextual factors and unconscious racial stereotypes. This is especially true when their cognitive and emotional resources are compromised due to factors such as stress. Similarly, key precursors to suicide among LEOs include chronic stress, exposure to trauma, alcohol misuse, and depression. The substantial personal, social, and economic costs of LEO stress, including unjustified shootings and suicide, suggest a clear need for innovative and novel prevention programs to promote well-being and reduce violence. Given its demonstrated impact on many of the precursors to self- and other-directed violence among LEOs, one possible approach is an adapted Mindfulness-Based Stress-Reduction (MBSR) program, developed specifically for LEOs. Therefore, the primary objectives of this proposal are to: (1) assess the feasibility of recruitment, adherence to program intervention, and compliance with assessment instruments, and (2) determine the impact of an adapted MBSR program (Mindfulness-Based Resilience Training; MBRT) on precursors to other- and self-directed violence, and in promoting psychological resilience and emotion regulation among LEOs. There is promising preliminary evidence suggesting that mindfulness is an effective strategy for LEOs to decrease stress and its negative outcomes, enhance resilience and emotion regulation, and ultimately reduce other- and self-directed violence. The proposed project will test the impact of MBRT using a pilot feasibility randomized controlled trial (RCT). This research will generate important information on the feasibility of recruitment, adherence to program intervention, and compliance with assessment instruments, and data obtained through the proposed study will build on the investigators existing work to provide support for a larger RCT examining the efficacy of MBRT in reducing violence.","other_id":"1R21AT008854-01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":21,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  full-time, active status, sworn-in law enforcement officers in the Portland Metro area\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  previously completed MBRT or MBSR course\r\n      ","sponsor":"Pacific University","sponsor_type":"Other","conditions":"Mindfulness","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: MBRT"}],"outcomes":[{"outcome_type":"primary","measure":"Depression Scores on the Patient Reported Outcomes Measurement Information System (PROMIS)","time_frame":"6 months"},{"outcome_type":"primary","measure":"Decision Making as measured by the Shooter Bias Task","time_frame":"8 weeks"}]}
{"nct_id":"NCT02539355","start_date":"2015-08-31","phase":"N/A","enrollment":16,"brief_title":"Diet and Metabolic Inflammation","official_title":"Diet and Metabolic Inflammation","primary_completion_date":"2016-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-09-30","last_update":"2016-10-24","description":"Obesity is a risk factor for several common cancers, including those of the breast, colon, liver, and pancreas. Proposed molecular links between obesity and these types of cancer include systemic inflammation, hyperinsulinemia, and changes in the serum concentrations of sex steroid hormones and adipokines. All of these are strongly linked to low-grade chronic inflammatory processes in expanded adipose tissue. The objective of this proposal is to test the hypothesis that adipose tissue inflammation can be reduced by the foods we eat.","other_id":"NCI2P30CA015704","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Body Mass Index (BMI)  28 kg/m2\r\n\r\n          -  Homeostasis model assessment insulin resistance (HOMA-IR) index > 2.0\r\n\r\n          -  Body weight within 10% of weight 3 months before starting the study\r\n\r\n          -  Able to come to the FHCRC Prevention Center for one 1-hour pre-study visit and two\r\n             clinic visits of ~4.5 hours duration each\r\n\r\n          -  Able and willing to attend bi-weekly dietary group counseling sessions at FHCRC during\r\n             the 12-week intervention period\r\n\r\n          -  Willingness and ability to follow the dietary regimen\r\n\r\n          -  Able to complete repeated 3-day food records before and during the dietary\r\n             intervention.\r\n\r\n          -  Willingness to maintain usual lifestyle habits (other than diet) throughout the study\r\n             (e.g., physical activity habits)\r\n\r\n          -  Ability to understand, speak, and write in English\r\n\r\n          -  Ability to provide informed written consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any previous or current use of antidiabetic medications or insulin\r\n\r\n          -  Presence or history of major chronic inflammatory or autoimmune disease (e.g., lupus,\r\n             rheumatoid arthritis, Hashimoto's thyroiditis, inflammatory bowel disease, celiac\r\n             disease, multiple sclerosis), malabsorption syndromes, or diseases of the liver,\r\n             thyroid, or kidneys (stage IV or later chronic kidney disease)\r\n\r\n          -  Food allergies or intolerances against major study foods\r\n\r\n          -  Intake of drugs likely to interfere with study endpoints, including corticosteroids\r\n             and anabolic steroids, hormone replacement therapy, NSAIDS (more than 3 times per week\r\n             and/ or more than 600 mg per day), warfarin (within 3 months of starting the study),\r\n             antibiotics or probiotics (within 2 weeks of starting the study)\r\n\r\n          -  Presence or recent history of anemia (within 3 months of starting the study)\r\n\r\n          -  Participation in another study that includes an intervention of any kind or a blood\r\n             draw >300 mL over 3 months\r\n\r\n          -  Alcohol intake > 2 drinks per day\r\n\r\n          -  Use of tobacco products, eCigarettes, or recreational drugs on more than 2 days per\r\n             month\r\n\r\n          -  Current or recent (within 12 months of starting the study) pregnancy or breastfeeding\r\n      ","sponsor":"Fred Hutchinson Cancer Research Center","sponsor_type":"Other","conditions":"Insulin Resistance|Diabetes|Cancer|Obesity|Inflammation","interventions":[{"intervention_type":"Other","name":"Other: Diet A","description":"12-week diet"},{"intervention_type":"Other","name":"Other: Diet B","description":"12-week Diet"}],"outcomes":[{"outcome_type":"secondary","measure":"Change in adipose tissue expression of the key anti-inflammatory adipokine, adiponectin assessed by qPCR","time_frame":"Change between beginning (day 1) and end (week 12) of the study diet period.","description":"Assessed by qPCR on whole abdominal subcutaneous adipose tissue"},{"outcome_type":"secondary","measure":"Change in systemic insulin sensitivity assessed by the Matsuda-DeFronzo Insulin Sensitivity Index","time_frame":"Change between beginning (day 1) and end (week 12) of the study diet period.","description":"Assessed by the Matsuda-DeFronzo Insulin Sensitivity Index (ISI) based on a 3-hour frequently sampled oral glucose tolerance test (FS-OGTT)"},{"outcome_type":"primary","measure":"Change in adipose tissue macrophage cell surface expression of metabolic activation marker CD36 as measured by relative mean fluorescence intensity","time_frame":"Change between beginning (day 1) and end (week 12) of the study diet period.","description":"As measured by relative mean fluorescence intensity (rMFI) on abdominal subcutaneous adipose tissue macrophages"},{"outcome_type":"primary","measure":"Change in adipose tissue macrophage cell surface expression of metabolic activation marker ABCA1 as measured by relative mean fluorescence intensity (rMFI)","time_frame":"Change between beginning (day 1) and end (week 12) of the study diet period.","description":"As measured by relative mean fluorescence intensity (rMFI) on abdominal subcutaneous adipose tissue macrophages"},{"outcome_type":"secondary","measure":"Change in adipose tissue expression of the key pro-inflammatory cytokine, tumor necrosis factor α (TNFα) assessed by qPCR","time_frame":"Change between beginning (day 1) and end (week 12) of the study diet period.","description":"Assessed by qPCR on whole abdominal subcutaneous adipose tissue"},{"outcome_type":"secondary","measure":"Change in adipose tissue expression of the key pro-inflammatory cytokine, interleukin-6 (IL-6) assessed by qPCR","time_frame":"Change between beginning (day 1) and end (week 12) of the study diet period.","description":"Assessed by qPCR on whole abdominal subcutaneous adipose tissue"},{"outcome_type":"secondary","measure":"Change in adipose tissue expression of the key pro-inflammatory cytokine, interleukin-1 beta (IL-1beta) assessed by qPCR","time_frame":"Change between beginning (day 1) and end (week 12) of the study diet period.","description":"Assessed by qPCR on whole abdominal subcutaneous adipose tissue"},{"outcome_type":"secondary","measure":"Change in oral glucose tolerance assessed by measuring total area under the curve glucose in the FS-OGTT","time_frame":"Change between beginning (day 1) and end (week 12) of the study diet period.","description":"Assessed by measuring total area under the curve glucose in the FS-OGTT"},{"outcome_type":"secondary","measure":"Change in fasting plasma C-reactive protein assessed by immunonephelometry","time_frame":"Change between beginning (day 1) and end (week 12) of the study diet period.","description":"Assessed by immunonephelometry"},{"outcome_type":"secondary","measure":"Change in fasting plasma IL-6 assessed by high-sensitivity ELISA","time_frame":"Change between beginning (day 1) and end (week 12) of the study diet period.","description":"Assessed by high-sensitivity ELISA"},{"outcome_type":"secondary","measure":"Change in fasting plasma total adiponectin assessed by ELISA","time_frame":"Change between beginning (day 1) and end (week 12) of the study diet period.","description":"Assessed by ELISA"},{"outcome_type":"other","measure":"Dietary adherence to prescribed 12-week diet assessed by dietary compliance score","time_frame":"Assessed at the end of the study (week 12).","description":"Assessed by dietary compliance score, based on data from repeated 4-day dietary records"},{"outcome_type":"other","measure":"Changes in gut microbiota assessed by stool sample analysis","time_frame":"Change between beginning (day 1) and end (week 12) of the study diet period.","description":"Assessed by stool sample analysis"}]}
{"nct_id":"NCT01762644","start_date":"2015-08-31","phase":"Phase 3","enrollment":0,"brief_title":"The Insulin Independence Trial (IIT) Evaluating the Safety and Efficacy of Oral Cyclosporine and Oral Omeprazole for Insulin Independence Among Recent Onset Type 1 Diabetes Patients","official_title":"A Phase IIB/III Multicenter Randomized Trial to Evaluate the Combination of Low-Dose Cyclosporine and Omeprazole Versus Omeprazole Alone in Participants With New Onset Type 1 Diabetes.","primary_completion_date":"2016-05-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2016-08-31","last_update":"2016-04-18","description":"The purpose of this study is to determine if the combination of oral cyclosporine, an immune therapy and oral omeprazole, a proton pump inhibitor, are effective in rendering insulin independence among recent onset type 1 diabetes patients. This two-arm study is designed to evaluate the safety and efficacy for insulin independence of two FDA and EMA-approved therapies among recent onset type 1 diabetes patients. One of the greatest new insights of today in the field of type 1 diabetes, is the understanding that in man, unlike the success seen in type 1 diabetes mouse models, there is no beta cell regeneration with immune therapy alone. In man, type 1 diabetes is now considered to be a disease of both autoimmunity and lack of beta cell regeneration (Levetan 2103). More than 500 patients with new onset type 1 diabetes have been given cyclosporine and some studies have demonstrated as high as a 57% insulin-free remission rate that was not sustained due to the lack of beta cell regeneration (Feutren 1986, Bougneres 1988, Eisenbarth 1989, Sobel 2010). Studies among diabetes patients with proton pump inhibitors have shown the potential to increase beta cell mass by 40%, but among type 1 patients without immune protection, such outcomes cannot be not achieved (Singh 2012, Griffin 2014). The usage of a beta cell regeneration agent such as omeprazole, in combination with an immune tolerance, like cyclosporine, provides both the potential ability to maintain and regenerate beta cells. This is a new paradigm for the treatment of new onset type 1 diabetes. More than 60 human trials have been conducted among type 1 diabetes with a variety of different therapies aimed at preventing autoimmune attack on insulin-producing beta cells. None have been as effective as cyclosporine in both slowing the decline in beta cell mass and resulting in the potential for insulin-free remissions. (Canadian-European Randomized Control Trial 1988, Eisenbarth 1989, Skyler 1992, Sobel 2010). Because cyclosporine is known for its potential side-effects, most notably in the kidney, all previous studies among type 1 patients have carefully monitored kidney function. Follow-up studies for up to 13 years among 285 type 1 patients utilizing cyclosporine for 20 months did not demonstrate renal or other side effects at the dosages that will be used in this trial (Assan 2002). The most effective initiating dosage for insulin independence in the cyclosporine trials was 7.5 mg/kg/day, but for safety, this study will begin at a lower dosage of 5 mg/kg/day and will monitor kidney function and cyclosporine levels initially on a weekly basis. This study will use only those dosages of cyclosporine that have not demonstrated toxicity to the kidney or resulted in non-reversible side effects among more than 500 patients with recent onset type 1 diabetes treated with cyclosporine. Omeprazole has been shown to significantly increase gastrin levels which is associated with increased beta cells. Lansoprazole has also been shown to be safe among patients with new onset type 1 diabetes for one year with a trend toward increased beta cell mass among patients with higher gastrin levels. In a randomized trial for 12 weeks among 56 patients undergoing pancreatectomy, those randomized to receive a proton pump inhibitor had significantly increased gastrin levels, higher insulin levels and improved endocrine function by glucose tolerance testing and less pancreatic atrophy as measured by CT scans (Jang 2003). The recently completed REPAIR T1D trial among newly diagnosed type 1 patients used a proton pump inhibitor and GLP-1 therapies for 1 year for beta regeneration failed to meet its endpoint of increased stimulated C-peptide. Lack of maintenance or regeneration of beta cells was specifically noted to have likely been due to lack of usage of immune therapy to protect beta cells (Griffin 2014, Rigby 2014). Those patients in REPAIR T1D, who did achieve gastrin and GLP-1 levels above those in the control group had a trend towards improved preservation of C-peptide with a suggestion of a decreased rate of fall of C-peptide through 12 months (Griffin 2014 Appendix Supplemental data). Glucose levels also trended lower than controls in the intervention arm with gastrin levels above the control arm (Griffin 2014 Appendix Supplemental data). In humans, the newly forming beta cells are under the greatest immune attack among type 1 patients (Meier 2006). REPAIR T1D underscores the importance for both immune therapy with a regeneration therapy among type 1 patients (Griffin 2014, Rigby 2014). The combination of cyclosporine with a proton pump inhibitor has the potential to demonstrate maintenance and expansion of residual beta cells. This combination therapy provides the unique ability for patients to become insulin independent. For a request of references, please email info@perlebioscience.com","other_id":"PRL001-PB-01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":10,"maximum_age":20,"population":"","criteria":"\n        Inclusion Criteria\r\n\r\n        Participants included in this study are those who meet all of the following criteria:\r\n\r\n          1. Male or female participant 10-20 years old.\r\n\r\n          2. Diagnosis of new onset type 1 diabetes within 12 weeks of symptoms according to the\r\n             American Diabetes Association (ADA) criteria.\r\n\r\n          3. History of at least one positive result on testing for any of the following\r\n             antibodies: Islet-cell autoantibodies 512 (ICA512)/islet antigen-2 (IA-2), Glutamic\r\n             Acid Decarboxylase (GAD) autoantibodies, Insulin autoantibodies.\r\n\r\n          4. Body weight > 30 kg.\r\n\r\n          5. Signs or symptoms of diabetes within 12 weeks of the first study visit.\r\n\r\n          6. Requires insulin > 0.2 units/kg body weight/day for T1DM\r\n\r\n          7. Fasting C-peptide greater than 0.3 ng/mL = 0.1 nmol/L = 100 pmol/L = 0.1 pmol/mL and\r\n             Glucagon Stimulated C-peptide greater than 0.6 ng/mL = 0.2 nmol/L = 200 pmol/L = 0.2\r\n             pmol/mL.\r\n\r\n          8. Female of child bearing potential must have a negative pregnancy test and practice\r\n             acceptable contraception [e.g., oral, intramuscular, or implanted hormonal\r\n             contraception, sexual partner with nonreversed vasectomy (with azoospermia in 2\r\n             tests), 2 barrier methods (e.g., condom, diaphragm, or spermicide), or intrauterine\r\n             device] or surgically sterile (tubal ligation or hysterectomy at least 6 months prior\r\n             to first clinic visit)]. Female of childbearing potential must undergo pregnancy\r\n             testing within 24 hours prior to administration of the first dose of study drug.\r\n\r\n          9. Able to swallow capsules.\r\n\r\n         10. Able to read, understand, and provide signed informed consent for the study\r\n             (participants under the age of 18, shall provide an assent for the study as per\r\n             country requirements).\r\n\r\n        Exclusion Criteria\r\n\r\n        Participants must not meet any of the following exclusion criteria to be eligible for the\r\n        study:\r\n\r\n          1. Any medical condition that, in the opinion of the investigator, would interfere with\r\n             safe completion of the trial or impact participant safety or evaluability of drug\r\n             effect.\r\n\r\n          2. Prior administration of immunosuppressants at any time in the past, including in a\r\n             clinical trial for type 1 diabetes.\r\n\r\n          3. Participation in any type of therapeutic drug or vaccine clinical trial within the\r\n             last 12 weeks prior to the first clinic visit.\r\n\r\n          4. Taking any prescription medications, vitamins or herbal supplements that are\r\n             contraindicated with cyclosporine within the last 14 days prior to first clinic visit.\r\n\r\n          5. Pregnant or lactating female.\r\n\r\n          6. Current therapy with GLP-1 receptor agonists (e.g., exenatide or pramlintide), or any\r\n             other agents that might stimulate pancreatic beta cell regeneration or insulin\r\n             secretion.\r\n\r\n          7. Current treatment with oral antidiabetic agents.\r\n\r\n          8. Evidence of active or latent tuberculosis.\r\n\r\n          9. Vaccination with a live virus or organism within the last 8 weeks prior to the first\r\n             clinic visit.\r\n\r\n         10. Influenza vaccination with a killed virus, including booster vaccinations, within the\r\n             last 4 weeks prior to the first clinic visit.\r\n\r\n         11. Vaccination with other antigens or killed organisms within the last 8 weeks prior to\r\n             the first clinic visit.\r\n\r\n         12. Any infectious mononucleosis-like illness within the last 6 months prior to the first\r\n             clinic visit.\r\n\r\n         13. History of or known active infection with HIV, HCV, or HBV.\r\n\r\n         14. Systolic or diastolic blood pressure >150 mmHg and > 90 mmHg, respectively, at the\r\n             first clinic visit.\r\n\r\n         15. 95% percentile for weight at the first clinic visit.\r\n\r\n         16. An aspartate transaminase (AST), alanine transaminase (ALT), or total bilirubin level\r\n             >2 times the upper limit of normal (ULN) at the first clinic visit.\r\n\r\n         17. A blood urea nitrogen (BUN) > 50 mg/dL (> 17.85 mmol/L) or a serum creatinine level >\r\n             1.3 mg/dL (> 115 mol/L) at the first clinic visit.\r\n\r\n         18. A serum amylase level > 1.5 times the ULN or a serum lipase level > 2 times the ULN at\r\n             the first clinic visit.\r\n\r\n         19. A history of substance abuse or dependence within the last 12 months prior to the\r\n             first clinic visit as defined by the Diagnostic and Statistical Manual of Mental\r\n             Disorders (DSM V) criteria.\r\n      ","sponsor":"Perle Bioscience, Inc.","sponsor_type":"Industry","conditions":"Type 1 Diabetes","interventions":[{"intervention_type":"Drug","name":"Drug: Oral Cyclosporine and Oral Omeprazole"},{"intervention_type":"Drug","name":"Drug: Oral Omeprazole"}],"outcomes":[{"outcome_type":"primary","measure":"Insulin Independence and Hemoglobin A1c (A1C) < 6.5%","time_frame":"24 weeks"},{"outcome_type":"secondary","measure":"Safety and tolerability","time_frame":"24 weeks"},{"outcome_type":"secondary","measure":"Pancreatic beta cell function measured by glucagon stimulated C-peptide response","time_frame":"24 weeks"},{"outcome_type":"secondary","measure":"Proportion of participants achieving insulin independence","time_frame":"24 weeks"},{"outcome_type":"secondary","measure":"Blood glucose control measured by A1C","time_frame":"24 weeks"},{"outcome_type":"secondary","measure":"Average daily insulin requirement per week","time_frame":"24 weeks"}]}
{"nct_id":"NCT02491216","start_date":"2015-08-31","phase":"N/A","enrollment":65,"brief_title":"A Study on Effects of Acupressure Among the Frail Elderly in Residential Care Services for the Elderly","official_title":"A Study on Effects of Acupressure Among the Frail Elderly in Homes for the Aged and Care and Attention Homes for the Elderly","primary_completion_date":"2016-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-03-31","last_update":"2016-05-12","description":"Acupressure has been used for thousands of years in China. Through applying pressure on the specific acupoints based on Traditional Chinese Medicine theory, acupressure could promote relaxation and wellness, balance yin-yang and treat diseases. The PI has been using acupressure to treat various diseases in the clinics of the School of Chinese Medicine, The University of Hong Kong. Acupressure has demonstrated significant efficacy in treating geriatric diseases, obstetric diseases, pediatric diseases, rheumatoid arthritis and various painful symptoms. When applying acupressure on the Head- Neck - Shoulder area, it could also help to improve insomnia, reduce pain, and regulate the mood of the patients. \"Frailty\" is a geriatric syndrome of growing importance in the medical field. Prevalence of frailty increases with age. As our life expectancy increase, there will be more elderly suffered from frailty in the later stage of their life. Although there is still a lack of universally accepted clinical definition for frailty, the syndrome is now commonly understood as decreased reserves in multiple systems, and lowered resilience to negative stress. Frailty could be initiated by single or multiple conditions including malnutrition, chronic diseases, lack of exercise, stress and physiological or social changes caused by aging. Its manifestation includes sarcopenia, anorexia, energy reduction, dysfunctional neuroendocrine system and a pro-inflammatory state. Frailty could affect the emotional state of the elderly, meanwhile, positive affect is protective against the functional and physical decline associated with frailty. There is limited treatment or medication for frailty. The investigators believe that acupressure could be a possible non invasive means to improve the general health conditions, including the emotional conditions of the frail elderly. In the past 2 years, the school of Chinese Medicine has been promoting acupressure as a health maintenance technique to the elderly, mostly frail elderly living in the community dwelling through seminars. It is in investigator's interest to run a prospective research to further understand the efficacy of acupressure in a wider range of frail elderly. The investigators would like to use a well-designed pragmatic randomized controlled trial (PRCT) to investigate if acupressure could help the frail elderly to improve their general quality of life","other_id":"CTC1215-2","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  a. Age: 65 years and older;\r\n\r\n          -  b. Gender: male or female;\r\n\r\n          -  c. Currently is a client served by the Residential Care services of YCHSS;\r\n\r\n          -  d. Demonstrate frailty: score 5 or more in the Tilburg Frailty Indicator (TFI);\r\n\r\n          -  e. Physically fit to sit on a normal chair for 15-20 mins for acupressure treatment;\r\n\r\n          -  f. Cognitively competent to understand the instruction from the practitioner and\r\n             participate actively in the exercise program offered by the Residential Care of\r\n             YCHSS);\r\n\r\n          -  g. Cognitively competent to sign the consent form: score 6 or more in Abbreviated\r\n             Mental Test (AMT, Hong Kong Version);\r\n\r\n          -  h. Signed the Patient/Subject Consent Form for this study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  a. Who is currently receiving acupressure or acupuncture as a regular therapy;\r\n\r\n          -  b. Who is decision impaired and unfit to sign the consent form;\r\n\r\n          -  c. Who is suffering from one of the related contraindications for acupressure\r\n             (including open sores; undiagnosed rashes; high fever; hypertensive emergence; sore\r\n             and enlarged lymph nodes; the site of an injury, surgery or injection; burn wounds;\r\n             skin ulcers and eczema);\r\n\r\n          -  d. Who is unable to comply to the set treatment schedule (20% non compliance is\r\n             allowed).\r\n      ","sponsor":"The University of Hong Kong","sponsor_type":"Other","conditions":"Impaired","interventions":[{"intervention_type":"Other","name":"Other: Acupressure","description":"A 15 minutes structured acupressure protocol with specific acupoints and applications technique will be performed on the elderly participants twice a week by the research team in YCHSS Homes. Designated para-medical staffs working in the elderly home or informal care giver of the elderly will be trained and perform the same acupressure protocol on the elderly at 2 additional occasions during the week. The total trial period is 12 weeks."}],"outcomes":[{"outcome_type":"primary","measure":"Change of quality of life","time_frame":"Baseline, 12 weeks, 6th months","description":"questionnaire: Short Form 12 questions Health Survey version 2 (SF-12,v2), Version for Hong Kong Chinese will be used to measure the quality of life of the elderly pre-treatment and post treatment."},{"outcome_type":"secondary","measure":"change of sleeping quality","time_frame":"Baseline, 12 weeks, 6th months","description":"questionnaire: Pittsburgh Sleep Quality Index (PSQI) will be used to assess the change in sleeping quality of the frail elderly pre-treatment and post treatment."},{"outcome_type":"secondary","measure":"change of blood pressure","time_frame":"Baseline, 12 weeks, 6th months","description":"Sphygmomanometer：Record of the blood pressure of the frail elderly will be logged pre- treatment and during the 12 weeks treatment period on a weekly basis."},{"outcome_type":"secondary","measure":"change of heart rate","time_frame":"Baseline, 12 weeks, 6th months","description":"Sphygmomanometer：Record of the heart rate of the frail elderly will be logged pre- treatment and during the 12 weeks treatment period on a weekly basis."}]}
{"nct_id":"NCT02520245","start_date":"2015-08-31","phase":"Phase 1","enrollment":0,"brief_title":"Companion Study for Patients Who Completed Participation in a REGN2810 (Anti-PD-1) Clinical Study","primary_completion_date":"2023-11-30","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2023-11-30","last_update":"2016-11-06","description":"This study has been designed to collect long-term follow-up information for patients who received REGN2810 in other clinical studies and to allow re-treatment for eligible patients.","other_id":"R2810-ONC-1425","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        The target population for this study is patients who have participated in any REGN2810\r\n        clinical study.\r\n\r\n        Inclusion Criteria for Patients Receiving Re-treatment:\r\n\r\n          1. Tolerated prior treatment with REGN2810 with no unacceptable toxicity (except select\r\n             reversible irAEs) requiring discontinuation of REGN2810\r\n\r\n          2. Developed documented progressive disease after first demonstrating clinical benefit\r\n             from their initial treatment\r\n\r\n          3. Eastern Cooperative Oncology Group (ECOG) performance status  1\r\n\r\n          4. 18 years old\r\n\r\n          5. Hepatic function:\r\n\r\n               -  Total bilirubin  1.5 x upper limit of normal (ULN; if liver metastases  3 x\r\n                  ULN)\r\n\r\n               -  Transaminases  3 x ULN (or  5.0 x ULN, if liver metastases)\r\n\r\n               -  Alkaline phosphatase (ALP)  2.5 x ULN (or  5.0 x ULN, if liver metastases)\r\n\r\n               -  For patients with hepatic metastases or hepatic malignancies, exclude patients\r\n                  with concomitant 3 x ULN  aspartate aminotransferase (AST) and/or alanine\r\n                  aminotransferase (ALT)  5 x ULN and 1.5 x ULN  total bilirubin  3 x ULN\r\n\r\n          6. Renal function: Serum creatinine  1.5 x ULN\r\n\r\n          7. Bone marrow function:\r\n\r\n               -  Hemoglobin  9.0 g/dL\r\n\r\n               -  Absolute neutrophil count (ANC)  1.5 x 10^9/L\r\n\r\n               -  Platelet count  75 x 10^9/L\r\n\r\n        Inclusion Criteria for Patients who Will not Receive Re-treatment:\r\n\r\n        Patients must have completed participation in any REGN2810 clinical study.\r\n\r\n        Exclusion Criteria:\r\n\r\n        A patient who meets any of the following criteria will be excluded from receiving\r\n        re-treatment with REGN2810:\r\n\r\n          1. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that\r\n             required treatment with systemic immunosuppressive treatments, which may suggest risk\r\n             for irAEs.\r\n\r\n          2. Patients who experienced an irAE in while participating in another REGN2810 protocol\r\n             who were unable to have their corticosteroid dose reduced to <10 mg per day prednisone\r\n             equivalent within 12 weeks of toxicity.\r\n\r\n          3. Patients who developed  Grade 2 uveitis in a prior REGN2810 protocol\r\n\r\n          4. Immunosuppressive corticosteroid doses (> 10 mg prednisone daily or equivalent) within\r\n             4 weeks prior to the first dose of REGN2810\r\n\r\n          5. Active infection requiring therapy, including known infection with human\r\n             immunodeficiency virus, or active infection with hepatitis B or hepatitis C virus.\r\n\r\n          6. History of pneumonitis within the last 5 years.\r\n\r\n          7. Any investigational or antitumor treatment within 30 days prior to the initial\r\n             administration of REGN2810.\r\n\r\n          8. History of documented allergic reactions or acute hypersensitivity reaction attributed\r\n             of Grade  3 severity during or directly following an REGN2810 infusion\r\n\r\n          9. Known allergy to doxycycline or tetracycline. (precaution due to presence of trace\r\n             components in REGN2810)\r\n\r\n         10. Breast-feeding\r\n\r\n         11. Positive serum pregnancy test\r\n\r\n         12. History within the last 5 years of an invasive malignancy other than the one treated\r\n             in this study, with the exception of resected/ablated basal or squamous-cell carcinoma\r\n             of the skin or carcinoma in situ of the cervix, or other local tumors considered cured\r\n             by local treatment.\r\n\r\n         13. Acute or chronic psychiatric problems that, under the evaluation of the investigator,\r\n             make the patient ineligible for participation\r\n\r\n         14. Unwilling to practice adequate contraception during the study until 6 months after the\r\n             last dose of study drug\r\n      ","sponsor":"Regeneron Pharmaceuticals","sponsor_type":"Industry","conditions":"Advanced Malignancies","interventions":[{"intervention_type":"Drug","name":"Drug: REGN2810","description":"Patients will receive REGN2810 by intravenous (IV) infusion"}],"outcomes":[{"outcome_type":"primary","measure":"Overall survival, from the first dose of study drug administered in the parent REGN2810 clinical study to death or date of last censoring","time_frame":"up to 8 years"},{"outcome_type":"primary","measure":"Safety measured by the number of patients with AEs, AEs leading to discontinuation, SAEs, drug-related AEs, Immune-related adverse events (irAEs), and death as outcome.","time_frame":"up to 8 years","description":"Safety includes the number of patients with AEs, AEs leading to discontinuation, SAEs, drug-related AEs, Immune-related adverse events (irAEs), and death as outcome."},{"outcome_type":"secondary","measure":"Response duration (time from best overall response of partial or complete response, to time to first documented disease progression)","time_frame":"up to 8 years"},{"outcome_type":"secondary","measure":"Duration of disease control (time from best overall response of SD as well as PR and CR to time to first do documented disease progression)","time_frame":"up to 8 years"}]}
{"nct_id":"NCT02601417","start_date":"2015-08-27","phase":"N/A","enrollment":440,"brief_title":"The Necessity of Bile Cultures in Patients With Acute Cholangitis","official_title":"The Necessity of Bile Cultures in Patients With Acute Cholangitis","primary_completion_date":"2018-08-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-02-28","last_update":"2017-09-08","description":"Acute cholangitis with obstructive jaundice is a condition which needs biliary drainage and appropriate antibiotics. Bile culture is an optional laboratory test according to 2013 Tokyo guideline, but the clinical significance is yet unproven. And its results might indicate less information of the true pathogen regarding normal flora. Previous study conducted at our institute found drug-resistant pathogens identified in bile culture had no impact on the outcome. So the investigators are conducting a multicenter randomized controlled trial comparing groups which considers both blood and bile culture as control and which considers only blood culture as trial group in order to prove bile culture provides no additional helpful clinical information.","other_id":"2015-1452","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosed acute cholangitis (as 2013 Tokyo guideline)\r\n\r\n          -  Percutaneous transhepatic biliary drainage\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pre-existing organ failure\r\n\r\n          -  Failure to obtain initial bile aspiration\r\n\r\n          -  Failed PTBD\r\n\r\n          -  Failure of full drainage via PTBD (all of the bile duct obstruction should be drained\r\n             via PTBD)\r\n\r\n          -  Organ failure from other causes\r\n      ","sponsor":"Seoul National University Hospital","sponsor_type":"Other","conditions":"Acute Cholangitis","interventions":[{"intervention_type":"Other","name":"Other: Ignoring result of bile culture","description":"Patients in the trial arm will do bile cultures which will not be considered when choosing antibiotics."}],"outcomes":[{"outcome_type":"primary","measure":"Organ Failure","time_frame":"48 hours","description":"Shock\r\nSystolic blood pressure under 90mmHg after adequate volume resuscitation\r\nVassopressors or inotropics needed to maintain effective circulation\r\nAcute kidney injury (KDIGO 2012)\r\nIncrease in SCr by >= 0.3mg/dl within 48 hours\r\nIncrease in SCr to >= 1.5 times baseline, known or presumed within 7 days\r\nUrine volume < 0.5mg/kg/h for 6 hours\r\nAltered mentality\r\nGlasgow coma scale (GCS) < 12\r\nor GCS score decrease > 3\r\nAcute respiratory distress\r\nPulse oxygen saturation < 90%\r\nMechanical ventilation applied"},{"outcome_type":"secondary","measure":"Hospital days","time_frame":"Expected average of 7 days"},{"outcome_type":"secondary","measure":"Re-intervention for biliary drainage","time_frame":"Expected average of 2 days"},{"outcome_type":"secondary","measure":"Mortality","time_frame":"Participants will be followed for the duration of hospital stay, an expected average of 2 weeks"}]}
{"nct_id":"NCT02518581","start_date":"2015-08-12","phase":"N/A","enrollment":10,"brief_title":"Validation of the Doubly Labelled Water Method in Subjects With Type 2 Diabetes Mellitus","official_title":"Estimating Free-living Human Energy Expenditure - Validation of the Doubly Labelled Water Method in Subjects With Type 2 Diabetes Mellitus","primary_completion_date":"2021-11-30","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2021-11-30","last_update":"2021-09-16","description":"The present study is an exploratory trial to establish a feasible DLW (doubly labelled water) protocol for implementation in clinical trials conducted at Profil Institut fr Stoffwechselforschung, investigating treatment options for overweight and obesity in populations with and without diabetic comorbidity. The study aims at the practical validation of a 1-2-week DLW protocol in overweight and obese type 2 diabetic subjects. Total Energy Expenditure (TEE) values as assessed by DLW will then be compared to (1) TEE as calculated based on individual anthropometric measurements (including body composition) using the Mller formula and the AEE (activity related energy expenditure) based on reported work place and leisure time activities and (2) TEE as calculated from measured REE (resting energy expenditure) as assessed by indirect calorimetry and the AEE based on information recorded by the subjects in a physical activity diary and corresponding pedometer counts. Moreover, TEE assessments will be repeated once (separated by 2-4 weeks) to determine intra-subject variability / re-test reliability of the measurement.","other_id":"OBDM-03","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":64,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Signed informed consent obtained before any trial-related activities.\r\n\r\n          2. Stable weight +/- 5% for at least 3 months prior screening visit.\r\n\r\n          3. Male or female subject, 18-64 years of age, both inclusive.\r\n\r\n          4. Body Mass Index (BMI) >= 25 kg/m2.\r\n\r\n          5. Type 2 diabetes mellitus (as diagnosed clinically)  12 months.\r\n\r\n          6. HbA1c <= 9 % at screening visit.\r\n\r\n          7. Stable treatment (>= 3 month) with\r\n\r\n               -  Oral antidiabetics (OADs) (except OADs that are associated with a reduction in\r\n                  body weight (-glucosidase inhibitors, sodium glucose transporter 2-inhibitors\r\n                  (SGLT2))) and/or\r\n\r\n               -  basal insulin injections and/or\r\n\r\n               -  a dietary regimen. Subjects on a basal-bolus insulin regimen will not be\r\n                  enrolled.\r\n\r\n          8. Considered generally healthy (apart from type 2 diabetes mellitus and with the\r\n             exception of conditions associated with diabetes mellitus or the metabolic syndrome,\r\n             such as dyslipidaemia and hypertension) upon completion of medical history, physical\r\n             examination, vital signs, and analysis of laboratory safety variables, as judged by\r\n             the Investigator.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Clinical significant acute illness within 2 weeks before study procedures, including\r\n             severe infections, as judged by the Investigator.\r\n\r\n          2. Receipt of any investigational medicinal product within 3 months before trial related\r\n             procedures.\r\n\r\n          3. Mental incapacity or language barriers which preclude adequate understanding or\r\n             cooperation, unwillingness to participate in the trial, known or suspected not to\r\n             comply with study directives or not to be reliable or trustworthy, or subjects who in\r\n             the opinion of their general practitioner or the Investigator should not participate\r\n             in the trial.\r\n\r\n          4. Use of diuretics.\r\n\r\n          5. Intake of any other drug or dietary supplement that in the opinion of the Investigator\r\n             may impair validity of energy expenditure assessments.\r\n\r\n          6. Clinically significant abnormal biochemistry screening tests, as judged by the\r\n             Investigator. In particular, elevated liver enzymes (AST or ALT > 3 times the upper\r\n             limit of normal) or impaired renal function with an estimated Glomerular Filtration\r\n             Rate (eGFR; estimate after CKD-EP) < 60 ml/min.\r\n\r\n          7. Clinically significant abnormal electrocardiogram (ECG) findings at screening, as\r\n             judged by the Investigator.\r\n\r\n          8. Positive alcohol breath test at screening visit.\r\n\r\n          9. Significant history of alcoholism or drug abuse as judged by the Investigator or\r\n             consuming more than 21 units of alcohol per week (one unit of alcohol equals about 330\r\n             ml of beer, one glass of wine of 120 ml, or 40 ml spirits).\r\n\r\n         10. Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent\r\n             per day) who is not able or willing to refrain from smoking and use of nicotine\r\n             substitute products during the study.\r\n\r\n         11. Excessive consumption of coffee and tea (i.e. more than 5 cups/day), chocolate or\r\n             beverages such as cola containing methylxanthine (caffeine, theophylline or\r\n             theobromine) as judged by the investigator.\r\n\r\n         12. Females of childbearing potential who are pregnant, breast-feeding or intend to become\r\n             pregnant or are not using adequate contraceptive methods (adequate contraceptive\r\n             measures include surgical sterilisation, hormonal intrauterine devices (coil), oral\r\n             hormonal contraceptives, sexual abstinence or a surgically sterilised partner).\r\n\r\n         13. Type 1 diabetes mellitus, diabetes resulting from pancreatic injury, or secondary\r\n             forms of diabetes, e.g., acromegaly or Cushing's syndrome.\r\n\r\n         14. History of hyperosmolar crisis, diabetic coma, or severe hypoglycemia within the last\r\n             3 months prior to trial examinations.\r\n\r\n         15. Use of weight-loss medication or any non-permitted antidiabetic medication that is\r\n             associated with a reduction in body weight (-glucosidase inhibitors,\r\n             SGLT2-inhibitors) within 3 months before trial examination.\r\n\r\n         16. Use of injectable anti-diabetic therapy (other than insulin), e.g. GLP-1 receptor\r\n             agonists (glucagon-like peptide), within 3 months prior to screening.\r\n\r\n         17. Steroid therapy other than topical application.\r\n      ","sponsor":"Profil Institut fr Stoffwechselforschung GmbH","sponsor_type":"Industry","conditions":"Diabetes","interventions":[{"intervention_type":"Procedure","name":"Procedure: Doubly labelled water method","description":"DLW (doubly labeled water) method measures isotope dilution spaces and elimination rates to assess total energy expenditure (TEE). After enriching the body water of a subject with DLW (2H and 18O), it is only necessary to collect urine samples at defined time points, usually over a period of 1-2 weeks, so that the measurement can be done in individuals able to engage in their typical habits without restrictions. The resulting TEE measurement represents an integral value over the measurement period."}],"outcomes":[{"outcome_type":"primary","measure":"Free-living total energy expenditure","time_frame":"up to 3 month","description":"Assessed by doubly labelled water"},{"outcome_type":"primary","measure":"Resting energy expenditure","time_frame":"up to 3 month","description":"Assessed by indirect calorimetry"},{"outcome_type":"primary","measure":"Activity-induced energy expenditure","time_frame":"up to 3 month","description":"Assessed by diary and pedometer"}]}
{"nct_id":"NCT02465060","start_date":"2015-08-12","phase":"Phase 2","enrollment":6452,"brief_title":"Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)","official_title":"Molecular Analysis for Therapy Choice (MATCH)","primary_completion_date":"2022-06-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-06-30","last_update":"2021-09-22","description":"This phase II MATCH trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.","other_id":"NCI-2015-00054","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  ELIGIBILITY CRITERIA FOR SCREENING BIOPSY (STEP 0)\r\n\r\n          -  Patients of childbearing potential must have a negative serum pregnancy test within 2\r\n             weeks prior to registration; patients that are pregnant or breast feeding are\r\n             excluded; a patient of childbearing potential is anyone, regardless of sexual\r\n             orientation or whether they have undergone tubal ligation, who meets the following\r\n             criteria:\r\n\r\n               -  Has achieved menarche at some point\r\n\r\n               -  Has not undergone a hysterectomy or bilateral oophorectomy; or\r\n\r\n               -  Has not been naturally postmenopausal for at least 24 consecutive months (i.e.,\r\n                  has had menses at any time in the preceding 24 consecutive months)\r\n\r\n          -  Patients must not expect to conceive or father children by using accepted and\r\n             effective method(s) of contraception or by abstaining from sexual intercourse prior to\r\n             study entry, for the duration of study participation, and for 4 months after\r\n             completion of study; should a patient or partner of the patient become pregnant or\r\n             suspect a pregnancy while participating in this study, the treating physician should\r\n             be informed immediately\r\n\r\n          -  Patients must have histologically documented solid tumors or histologically confirmed\r\n             diagnosis of lymphoma or multiple myeloma requiring therapy and meet one of the\r\n             following criteria:\r\n\r\n               -  Patients must have progressed following at least one line of standard systemic\r\n                  therapy and there must not be other approval/standard therapy available that has\r\n                  been shown to prolong overall survival (i.e. in a randomized trial against\r\n                  another standard treatment or by comparison to historical controls); patients who\r\n                  cannot receive other standard therapy that has been shown to prolong overall\r\n                  survival due to medical issues will be eligible, if other eligibility criteria\r\n                  are met; if the patient is currently receiving therapy, the clinician must have\r\n                  assessed that the current therapy is no longer benefitting the patient prior to\r\n                  enrolling on MATCH, regardless of whether it is considered standard OR\r\n\r\n               -  Patients for whose disease no standard treatment exists that has been shown to\r\n                  prolong overall survival\r\n\r\n               -  NOTE: No other prior malignancy is allowed except for the following:\r\n\r\n               -  Adequately treated basal cell or squamous cell skin cancer\r\n\r\n               -  In situ cervical cancer\r\n\r\n               -  Adequately treated stage I or II cancer from which the patient is currently in\r\n                  complete remission\r\n\r\n               -  Any other cancer from which the patient has been disease-free for 5 years\r\n\r\n          -  Patients must have measurable disease\r\n\r\n          -  Patients must meet the criteria below\r\n\r\n               -  Tumor tissue for the confirmation of \"rare variant\" by the MATCH assay is to be\r\n                  submitted, preferably from the same time of collection as that used to determine\r\n                  patient candidacy for treatment arm assignment\r\n\r\n                    -  Registration to Step 0 must occur after stopping prior systemic anti-cancer\r\n                       therapy. There is no specific duration for which patients must be off\r\n                       treatment prior to registration to Step 0, as long as all eligibility\r\n                       criteria are met\r\n\r\n                    -  Patients may have received other non-targeted, immunotherapy or targeted\r\n                       treatment between the prior genetic testing at the outside lab and\r\n                       registration to Step 0. The decision to stop such treatment in favor of\r\n                       participation in MATCH, if no further clinical benefit is expected, is per\r\n                       the treating physician's discretion. Documentation of a lack of response to\r\n                       the prior treatment is not required in these cases\r\n\r\n                    -  Patients with an applicable \"rare variant\" must be able to meet the\r\n                       eligibility criteria for the appropriate subprotocols within 4 weeks\r\n                       following notification of treatment assignment\r\n\r\n                    -  Patient meets one of the following criteria:\r\n\r\n                         -  Patient is a candidate for Z1M based on local CLIA assessment of MMRd\r\n                            by immunohistochemistry (IHC) or MSI status by polymerase chain\r\n                            reaction (PCR), adequate tumor tissue is available for submission for\r\n                            mandatory central screening IHC and the patient will be able to meet\r\n                            the eligibility criteria for Z1M within 4 weeks following notification\r\n                            of treatment assignment OR\r\n\r\n                         -  The sites have received results from one of the designated outside\r\n                            laboratories indicating a \"rare variant\" that is an actionable Mutation\r\n                            of Interest (aMOI) for specific select subprotocols\r\n\r\n               -  NOTE: There is no particular window of time after receiving the sequencing report\r\n                  notification of potential eligibility from an outside lab in which the patient\r\n                  must be registered to Step 0, but treatment slots will be assigned on a first\r\n                  come, first serve basis to those who do register to Step 0, and are not held for\r\n                  those notified of potential eligibility who do not register to Step 0\r\n\r\n               -  NOTE: Treatment assignment (and the start of the associated deadline for Step 1\r\n                  registration) may occur shortly after Step 0 registration. Note that certain\r\n                  \"rare variant\" arms require submission of archival tissue for central IHC testing\r\n                  to determine treatment assignment. For those arms, adequate tissue for the\r\n                  central IHC is required to be available for submission\r\n\r\n               -  NOTE: Other potential aMOIs that would be eligibility criteria for \"NON RARE\"\r\n                  arms, as determined by the designated laboratories, are not applicable for this\r\n                  process in MATCH\r\n\r\n          -  Patients must have Eastern Cooperative Oncology Group (ECOG) performance status =< 1\r\n             and a life expectancy of at least 3 months\r\n\r\n          -  Patients must be able to swallow tablets or capsules; a patient with any\r\n             gastrointestinal disease that would impair ability to swallow, retain, or absorb drug\r\n             is not eligible\r\n\r\n          -  Patients who are human immunodeficiency virus (HIV)-positive are eligible if:\r\n\r\n               -  CD4+ cell count greater or equal to 250 cells/mm^3\r\n\r\n               -  If patient is on antiretroviral therapy, there must be minimal interactions or\r\n                  overlapping toxicity of the antiretroviral therapy with the experimental cancer\r\n                  treatment; for experimental cancer therapeutics with CYP3A/4 interactions,\r\n                  protease inhibitor therapy is disallowed; suggested regimens to replace protease\r\n                  inhibitor therapy include dolutegravir given with tenofovir/emtricitabine;\r\n                  raltegravir given with tenofovir and emtricitabine; once daily combinations that\r\n                  use pharmacologic boosters may not be used\r\n\r\n               -  No history of non-malignancy acquired immune deficiency syndrome (AIDS)-defining\r\n                  conditions other than historical low CD4+ cell counts\r\n\r\n               -  Probable long-term survival with HIV if cancer were not present\r\n\r\n          -  Any prior therapy, radiotherapy (except palliative radiation therapy of 30 gray [Gy]\r\n             or less), or major surgery must have been completed >= 4 weeks prior to start of\r\n             treatment; all adverse events due to prior therapy have resolved to a grade 1 or\r\n             better (except alopecia and lymphopenia) by start of treatment; palliative radiation\r\n             therapy must have been completed at least 2 weeks prior to start of treatment; the\r\n             radiotherapy must not be to a lesion that is included as measurable disease\r\n\r\n               -  NOTE: Prostate cancer patients may continue their luteinizing hormone-releasing\r\n                  hormone (LHRH) agonist\r\n\r\n               -  NOTE: For patients entering the study via the original screening process,\r\n                  patients may receive non-protocol treatment after biopsy (if clinically\r\n                  indicated) until they receive notification of results; however, lack of response\r\n                  must be documented prior to registration to Step 1; new non-protocol treatment\r\n                  will NOT be permitted as intervening therapy after registration to Step 0; the\r\n                  only intervening treatment permitted is prior therapy that the patient already\r\n                  received prior to Step 0 registration; the decision to stop the intervening\r\n                  non-protocol treatment will be left up to the treating physician if patient has\r\n                  an aMOI; however, patients will need to be off such therapy for at least 4 weeks\r\n                  before receiving any MATCH protocol treatment\r\n\r\n               -  NOTE: For patients entering the study via a designated outside laboratory, no\r\n                  intervening systemic non-protocol treatment is permitted after Step 0\r\n                  registration; all other eligibility requirements still apply to these patients,\r\n                  including the washouts for prior therapy noted above in this section, the time\r\n                  restrictions outlined, and the eligibility criteria for the intended subprotocol\r\n\r\n          -  Patients with brain metastases or primary brain tumors must have completed treatment,\r\n             surgery or radiation therapy >= 4 weeks prior to start of treatment\r\n\r\n          -  Patients must have discontinued steroids >= 1 week prior to registration to Step 0 and\r\n             remain off steroids thereafter, except as permitted; patients with glioblastoma (GBM)\r\n             must have been on stable dose of steroids, or be off steroids, for one week prior to\r\n             registration to treatment (Step 1, 3, 5, 7)\r\n\r\n               -  NOTE: The following steroids are permitted (low dose steroid use is defined as\r\n                  prednisone 10 mg daily or less, or bioequivalent dose of other corticosteroid):\r\n\r\n                    -  Temporary steroid use: e.g. for computed tomography (CT) imaging in setting\r\n                       of contrast allergy\r\n\r\n                    -  Low dose steroid use for appetite\r\n\r\n                    -  Chronic inhaled steroid use\r\n\r\n                    -  Steroid injections for joint disease\r\n\r\n                    -  Stable dose of replacement steroid for adrenal insufficiency or low doses\r\n                       for non-malignant disease\r\n\r\n                    -  Topical steroid\r\n\r\n                    -  Steroids required to manage toxicity related to study treatment, as\r\n                       described in the subprotocols\r\n\r\n                    -  Steroids required as pre- or post-chemotherapy medication for acceptable\r\n                       intervening chemotherapy\r\n\r\n                         -  NOTE: Steroids must be completed alongside last dose of chemotherapy\r\n\r\n          -  Leukocytes >= 3,000/mcL (within 2 weeks prior to screening step registration and\r\n             within 4 weeks prior to treatment step registration)\r\n\r\n          -  Absolute neutrophil count (ANC) >= 1,500/mcL (within 2 weeks prior to screening step\r\n             registration and within 4 weeks prior to treatment step registration)\r\n\r\n          -  Platelets >= 100,000/mcL (within 2 weeks prior to screening step registration and\r\n             within 4 weeks prior to treatment step registration)\r\n\r\n          -  NOTE: Patients with documented bone marrow involvement by lymphoma are not required to\r\n             meet the above hematologic parameters, but must have a platelet count of at least\r\n             75,000/mcL and neutrophil count of at least 1,000/mcL\r\n\r\n          -  Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (unless documented\r\n             Gilbert's syndrome, for which bilirubin =< 3 x institutional ULN is permitted) (within\r\n             2 weeks prior to screening step registration and within 4 weeks prior to treatment\r\n             step registration)\r\n\r\n          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase\r\n             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])\r\n             =< 2.5 x institutional ULN (up to 5 times ULN in presence of liver metastases) (within\r\n             2 weeks prior to screening step registration and within 4 weeks prior to treatment\r\n             step registration)\r\n\r\n          -  Creatinine clearance >= 45 mL/min/1.73 m^2 for patients with creatinine levels above\r\n             institutional ULN\r\n\r\n               -  As defined by the Cockcroft-Gault equation (within 2 weeks prior to screening\r\n                  step registration and within 4 weeks prior to treatment step registration)\r\n\r\n          -  Patients must have an electrocardiogram (ECG) within 8 weeks prior to registration to\r\n             screening step and must meet the following cardiac criteria:\r\n\r\n               -  Resting corrected QT interval (QTc) =< 480 msec\r\n\r\n                    -  NOTE: If the first recorded QTc exceeds 480 msec, two additional,\r\n                       consecutive ECGs are required and must result in a mean resting QTc =< 480\r\n                       msec; it is recommended that there are 10-minute (+/- 5 minutes) breaks\r\n                       between the ECGs\r\n\r\n               -  The following only need to be assessed if the mean QTc > 480 msec\r\n\r\n                    -  Check potassium and magnesium serum levels\r\n\r\n                    -  Correct any identified hypokalemia and/or hypomagnesemia and may repeat ECG\r\n                       to confirm exclusion of patient due to QTc\r\n\r\n                    -  For patients with heart rate (HR) 60-100 beats per minute (bpm), no manual\r\n                       read of QTc is required\r\n\r\n                    -  For patients with baseline HR < 60 or > 100 bpm, manual read of QT by\r\n                       trained personnel is required, with Fridericia correction applied to\r\n                       determine QTc\r\n\r\n                    -  Patient must not have hypokalemia (value < institutional lower limit of\r\n                       normal)\r\n\r\n               -  No factors that increase the risk of QTc prolongation or risk of arrhythmic\r\n                  events such as heart failure, congenital long QT syndrome, family history of long\r\n                  QT syndrome or unexplained sudden death under 40 years of age or any concomitant\r\n                  medication known to prolong the QT interval\r\n\r\n                    -  NOTE: Patient must be taken off prohibited medication prior to registration\r\n                       to the screening step (Step 0, 2, 4, 6) and remain off these medications\r\n                       thereafter, unless permitted on a subprotocol for the management of\r\n                       treatment related toxicity; patient must be off the drug for at least 5\r\n                       half-lives prior to registration to the treatment step (Step 1, 3, 5, 7);\r\n                       the medication half-life can be found in the package insert for Food and\r\n                       Drug Administration (FDA) approved drugs\r\n\r\n          -  ELIGIBILITY CRITERIA FOR FIRST TREATMENT (STEP 1)\r\n\r\n          -  NOTE: For patients entering step 0 with assay results from outside laboratories, no\r\n             systemic treatment is allowed after step 0 registration\r\n\r\n          -  As MATCH is designed to add additional subprotocols, implement limited expansions of\r\n             accrual for certain subprotocols, and/or amend existing arm-specific eligibility\r\n             criteria, some patients entering under the original screening method may be eligible\r\n             to have their results rerun in MATCHbox, even if they did not match to a treatment\r\n             initially or did not receive a treatment assignment due to a lack of available\r\n             assignment slots; patients whose sequence results will be rerun through MATCHbox must\r\n             also meet the following criteria:\r\n\r\n               -  Samples must have been collected within 5 months of the activation of the\r\n                  addendum, as there is an additional month needed to get the patients on trial\r\n\r\n               -  Patient has not had treatment within the 5 months that resulted in a PR or better\r\n                  after the performance of the screening assessment\r\n\r\n               -  Patient must meet eligibility criteria, including performance status 1 or better\r\n                  and life expectancy of at least 3 months\r\n\r\n               -  Patients must meet the eligibility requirements with the following exceptions:\r\n\r\n                    -  Patients may have received other non-targeted, immunotherapy or targeted\r\n                       treatment, which could be stopped in favor of returning to MATCH, if no\r\n                       response to the interim treatment has occurred and no further benefit is\r\n                       expected from this interim treatment, per the treating physician's\r\n                       discretion; documentation of a lack of response to the interim treatment is\r\n                       not required in these cases; however, the following restrictions apply:\r\n\r\n                         -  Enrollment onto another investigational therapeutic study is not\r\n                            permitted\r\n\r\n                         -  Patient cannot be responding to interim treatment, since the benefit of\r\n                            the MATCH treatment is unknown and may deprive patient of an effective\r\n                            treatment if it were given when a patient is responding to another\r\n                            treatment\r\n\r\n               -  NOTE: Patients meeting these criteria will NOT be biopsied at this time point;\r\n                  instead, their step 0 results will be re-interrogated to determine if another\r\n                  treatment is available\r\n\r\n          -  ELIGIBILITY CRITERIA FOR SECOND SCREENING (STEP 2)\r\n\r\n          -  Patient's disease\r\n      ","sponsor":"National Cancer Institute (NCI)","sponsor_type":"NIH","conditions":"Liver and Intrahepatic Bile Duct Carcinoma|Kidney Carcinoma|Head and Neck Carcinoma|Glioma|Gastric Carcinoma|Esophageal Carcinoma|Endometrial Carcinoma|Colorectal Carcinoma|Colon Carcinoma|Cervical Carcinoma|Breast Carcinoma|Bladder Carcinoma|Advanced Malignant Solid Neoplasm|Uterine Corpus Cancer|Thyroid Gland Carcinoma|Skin Carcinoma|Refractory Plasma Cell Myeloma|Refractory Malignant Solid Neoplasm|Refractory Lymphoma|Recurrent Uterine Corpus Cancer|Recurrent Thyroid Gland Carcinoma|Recurrent Skin Carcinoma|Recurrent Rectal Carcinoma|Recurrent Prostate Carcinoma|Recurrent Plasma Cell Myeloma|Recurrent Pancreatic Carcinoma|Recurrent Ovarian Carcinoma|Recurrent Melanoma|Recurrent Malignant Solid Neoplasm|Recurrent Lymphoma|Recurrent Lung Carcinoma|Recurrent Liver Carcinoma|Recurrent Head and Neck Carcinoma|Recurrent Glioma|Recurrent Gastric Carcinoma|Recurrent Esophageal Carcinoma|Recurrent Colorectal Carcinoma|Recurrent Colon Carcinoma|Recurrent Cervical Carcinoma|Recurrent Breast Carcinoma|Recurrent Bladder Carcinoma|Rectal Carcinoma|Prostate Carcinoma|Plasma Cell Myeloma|Pancreatic Carcinoma|Ovarian Carcinoma|Melanoma|Malignant Uterine Neoplasm|Lymphoma|Lung Carcinoma","interventions":[{"intervention_type":"Drug","name":"Drug: Binimetinib","description":"Given PO"},{"intervention_type":"Drug","name":"Drug: Capivasertib","description":"Given PO"},{"intervention_type":"Drug","name":"Drug: Adavosertib","description":"Given PO"},{"intervention_type":"Drug","name":"Drug: Afatinib","description":"Given PO"},{"intervention_type":"Drug","name":"Drug: Afatinib Dimaleate","description":"Given PO"},{"intervention_type":"Drug","name":"Drug: Copanlisib","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: Copanlisib Hydrochloride","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: Crizotinib","description":"Given PO"},{"intervention_type":"Other","name":"Other: Cytology Specimen Collection Procedure","description":"Optional correlative studies"},{"intervention_type":"Drug","name":"Drug: Dabrafenib","description":"Given PO"},{"intervention_type":"Drug","name":"Drug: Dabrafenib Mesylate","description":"Given PO"},{"intervention_type":"Drug","name":"Drug: Dasatinib","description":"Given PO"},{"intervention_type":"Drug","name":"Drug: Defactinib","description":"Given PO"},{"intervention_type":"Drug","name":"Drug: Defactinib Hydrochloride","description":"Given PO"},{"intervention_type":"Drug","name":"Drug: Erdafitinib","description":"Given PO"},{"intervention_type":"Drug","name":"Drug: FGFR Inhibitor AZD4547","description":"Given PO"},{"intervention_type":"Drug","name":"Drug: Ipatasertib","description":"Given PO"},{"intervention_type":"Other","name":"Other: Laboratory Biomarker Analysis","description":"Undergo molecular analysis"},{"intervention_type":"Drug","name":"Drug: Larotrectinib","description":"Given PO"},{"intervention_type":"Drug","name":"Drug: Larotrectinib Sulfate","description":"Given PO"},{"intervention_type":"Biological","name":"Biological: Nivolumab","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: Osimertinib","description":"Given PO"},{"intervention_type":"Drug","name":"Drug: Palbociclib","description":"Given PO"},{"intervention_type":"Biological","name":"Biological: Pertuzumab","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: PI3K-beta Inhibitor GSK2636771","description":"Given PO"},{"intervention_type":"Biological","name":"Biological: Relatlimab","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: Sapanisertib","description":"Given PO"},{"intervention_type":"Drug","name":"Drug: Sunitinib Malate","description":"Given PO"},{"intervention_type":"Drug","name":"Drug: Taselisib","description":"Given PO"},{"intervention_type":"Drug","name":"Drug: Trametinib","description":"Given PO"},{"intervention_type":"Biological","name":"Biological: Trastuzumab","description":"Given IV"},{"intervention_type":"Biological","name":"Biological: Trastuzumab Emtansine","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: Ulixertinib","description":"Give PO"},{"intervention_type":"Drug","name":"Drug: Vismodegib","description":"Given PO"}],"outcomes":[{"outcome_type":"primary","measure":"Objective response rate","time_frame":"Up to 3 years","description":"Defined as the percentage of patients whose tumors have a complete or partial response to treatment. Objective response rate is defined consistent with Response Evaluation Criteria in Solid Tumors version 1.1 criteria for solid tumors, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. For each treatment arm, 90% two-sided confidence intervals will be calculated."},{"outcome_type":"secondary","measure":"Overall survival","time_frame":"From registration onto that step until death, or censored at the date of last contact, assessed up to 3 years","description":"Will be evaluated specifically for each drug (or step). Overall survival will be estimated using the Kaplan-Meier method."},{"outcome_type":"secondary","measure":"Progression free survival","time_frame":"From entry onto that step until determination of disease progression or death from any cause, censored at the date of last disease assessment for patients who have not progressed, assessed at 6 months","description":"Progression free survival will be estimated using the Kaplan-Meier method. For each treatment arm, 90% two-sided confidence intervals will be calculated."}]}
{"nct_id":"NCT02893345","start_date":"2015-08-08","phase":"Phase 2","enrollment":60,"brief_title":"Safe@Home: A Self-Management Program for Individuals With TBI and Their Families","official_title":"Safe@Home: A Self-Management Program for Individuals With Traumatic Brain Injury and Their Families","primary_completion_date":"2017-08-15","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2017-11-15","last_update":"2017-10-06","description":"People who sustain moderate to severe traumatic brain injury (TBI) have an increased risk for unintentional injury and harm when resuming day to day activities in the home and community. People who sustain brain injuries primarily want to independently do the activities they enjoy while families primarily focus on avoiding injury or other harm events. Safe@Home is an injury prevention education and activity training program. Participants who have sustained a moderate or severe TBI receive a personalized strengths and safety risk assessment, tailored injury prevention education, and in-home training with a transition coach on self-selected activities. This study will evaluate whether the Safe@Home program reduces injuries and harm and increases clients' independence in their everyday activities in the home and community compared to a usual care control group.","other_id":"627-605210-2","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":99,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Persons with TBI and family members will be eligible if they meet all of the following\r\n        criteria:\r\n\r\n          1. Person with TBI aged 18 or older who sustained moderate to severe TBI defined as\r\n             externally caused damage to brain tissue as evidenced by one of the following (TBI\r\n             Model Systems Criteria):\r\n\r\n               -  Post-traumatic Amnesia (PTA) > 24 hours\r\n\r\n               -  Trauma related intracranial neuroimaging abnormalities\r\n\r\n               -  Loss of consciousness exceeding 30 minutes (and not due to sedation or\r\n                  intoxication)\r\n\r\n               -  Glasgow Coma Scale (GCS) score in the emergency department of less than 13 (and\r\n                  not due to intubation, sedation, or intoxication)\r\n\r\n          2. All participants must be capable of providing informed consent for research\r\n             participation.\r\n\r\n          3. Person with TBI has capacity to manage self-care as defined by a rehabilitation\r\n             specialist rating the patient on the Mayo-Portland Self-Care item  2, i.e., requires\r\n             a little assistance or supervision from others, 24% of the time.\r\n\r\n          4. An adult family member, e.g., parent, spouse, adult child, or committed, domestic\r\n             partner, aged 18 or older, living in the home environment is willing to participate.\r\n\r\n          5. Person-family resides within 75 miles of the enrollment site and willing to allow a\r\n             personal transition coach into the home.\r\n\r\n          6. Person-family willing to use the internet or a mobile phone as part of the\r\n             intervention.\r\n\r\n          7. Person-family are English speaking, either native or English as a second language.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Person with brain injury primary diagnosis is hypoxic or hypoxic-ischemic (i.e.,\r\n             anoxic) brain injury; cerebral infarction (ischemic stroke) or cerebral hemorrhage\r\n             (i.e., hemorrhagic stroke); intracranial hemorrhage (i.e., aneurismal rupture,\r\n             subdural or epidural hematoma without TBI); inflammatory, toxic, or metabolic\r\n             encephalopathies which are not complications of head trauma; seizure disorders\r\n             (primary generalized epilepsy, partial epilepsies, status epilepticus, etc.); cerebral\r\n             neoplasm; intracranial surgery; or condition other than moderate or severe TBI as\r\n             defined above.\r\n\r\n          2. Person with TBI could not self-manage activities prior to their injury due to severe,\r\n             uncontrolled psychopathology (e.g., schizophrenia, bipolar disorder) or developmental\r\n             disability.\r\n\r\n          3. Person or family has current, severe, untreated/uncontrolled psychopathology (e.g.,\r\n             physically abusive, violent or sexual behavior) that places the personal transition\r\n             coach treating in the home at physical risk.\r\n\r\n          4. Person with TBI has severe, current physical or sensory impairment (e.g., tetraplegia,\r\n             legally blind) that prohibits participation in all activity modules and reflects\r\n             membership in a different population.\r\n      ","sponsor":"Shepherd Center, Atlanta GA","sponsor_type":"Other","conditions":"Brain Injuries, Traumatic","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Safe@Home Intervention Group","description":"For the 8 training visits, participants may select to work on skills in 2 of 5 activity modules: Improving mobility, balance and strength; Managing health and wellness; Staying On Your Own at Home; Maintaining the home; Getting out in the community. Participants may seek single service rehabilitation, medical, and psychological care as usual."},{"intervention_type":"Other","name":"Other: Usual Care Group","description":"Persons can set goals and work on activities with or without a family member as they so choose. Participants may seek single service rehabilitation, medical, and psychological care as usual."}],"outcomes":[{"outcome_type":"primary","measure":"Number of Unsafe Events for Each Participant","time_frame":"From study start to intervention conclusion (~3-months)","description":"Actual and near miss unsafe events including injury to self or others, and property damage or loss using a standardized survey"},{"outcome_type":"primary","measure":"Change in Mayo-Portland Participation Scale Score","time_frame":"Baseline measure and post-intervention measure (~3-months post-baseline)","description":"Eight items in which amount and level of independence in activities is rated on a 5-point scale"},{"outcome_type":"secondary","measure":"Change in Supervision Rating Scale Score","time_frame":"Baseline, post-intervention (3-months post-baseline), and 3-months post-intervention (6-months post-baseline)","description":"Amount of supervision provided by a family member on a 13 point scale"},{"outcome_type":"secondary","measure":"Change in Carrying Out Activities Scale Score","time_frame":"Baseline, post-intervention (3-months post-baseline), and 3-months post-intervention (6-months post-baseline)","description":"Measures level of safety risk associated with cognitive impairment using 17 items rated on a 4-point scale"},{"outcome_type":"secondary","measure":"Number of Unsafe Events for Each Participant","time_frame":"From intervention conclusion to 3-months post-intervention","description":"Actual and near miss unsafe events including injury to self or others, and property damage or loss using a standardized survey"},{"outcome_type":"secondary","measure":"Change in Mayo-Portland Participation Scale Score","time_frame":"Baseline measure and 3-month post-intervention measure (6-months post-baseline)","description":"Eight items in which amount and level of independence in activities is rated on a 5-point scale"}]}
{"nct_id":"NCT02500576","start_date":"2015-08-07","phase":"Phase 2","enrollment":36,"brief_title":"Pembrolizumab, Standard Chemotherapy, Tumor Infiltrating Lymphocytes, and High- or Low-Dose Aldesleukin in Treating Patients With Metastatic Melanoma","official_title":"Phase II Study of MK-3475 in Conjunction With Lymphodepletion, TIL, and High or Low Dose IL-2 in Patients With Metastatic Melanoma","primary_completion_date":"2022-08-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2022-08-31","last_update":"2021-02-05","description":"This randomized phase II trial studies how well giving pembrolizumab with standard chemotherapy, tumor infiltrating lymphocytes (TIL), and aldesleukin works in treating patients with melanoma that has spread to other areas of the body. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide and fludarabine phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving an infusion of TIL, or white blood cells, may help stimulate the immune system to help kill more cells. Aldesleukin may also stimulate the white blood cells to kill melanoma cells. Giving pembrolizumab together with standard chemotherapy, TIL, and high- or low-dose aldesleukin may help stop the melanoma from spreading.","other_id":"2014-0922","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  TURNSTILE I - SCREENING:\r\n\r\n          -  Patients must have metastatic melanoma or stage III in-transit, subcutaneous, or\r\n             regional nodal disease\r\n\r\n          -  Patients must have a lesion amenable to resection for the generation of TIL on MD\r\n             Anderson protocol 2004-0069\r\n\r\n          -  Patients must receive a magnetic resonance imaging (MRI)/computed tomography\r\n             (CT)/positron emission tomography (PET) of the brain within 6 months of signing\r\n             informed consent; if new central nervous system (CNS) lesions are present, patient\r\n             must have definitive treatment (including surgery or radiation); principal\r\n             investigator (PI) or his designee should make final determination regarding enrollment\r\n\r\n          -  Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0 - 1 within\r\n             30 days of signing informed consent\r\n\r\n          -  Patients previously treated with immunotherapy, targeted therapy, or no therapy\r\n             (treatment naive) will be eligible\r\n\r\n          -  Patients receiving cytotoxic agents will be evaluated by the PI or his designee for\r\n             eligibility suitability\r\n\r\n          -  Patients with a negative pregnancy test (urine or serum) must be documented within 14\r\n             days of screening for women of childbearing potential (WOCBP); a WOCBP has not\r\n             undergone a hysterectomy or who has not been naturally postmenopausal for at least 12\r\n             consecutive months (i.e. who has not had menses at any time in the preceding 12\r\n             consecutive months)\r\n\r\n          -  TURNSTILE II - TREATMENT:\r\n\r\n          -  Patients must sign the treatment consent document before Turnstile II screening\r\n             procedures; before the treatment starts and at each visit, the patient will be asked\r\n             to complete two quality of life questionnaires; It should take about 15 minutes to\r\n             complete the questionnaires (Functional Assessment of Cancer Therapy General [FACT-G],\r\n             FACT-Melanoma); patients must fulfill all of the following criteria to be eligible for\r\n             Turnstile II of the study\r\n\r\n          -  Patients must have adequate TIL that were previously harvested and then cryopreserved\r\n             on MD Anderson Cancer Center (MDACC) protocol 2004-0069\r\n\r\n          -  Patients who have had prior therapy (BRAF inhibitors, ipilimumab, anti PD-1 antibody\r\n             or anti PD-L1 antibody) or treatment naive patients are eligible as long as toxicity\r\n             from therapy is grade =< 1 or at baseline\r\n\r\n          -  Patients must have at least one biopsiable measurable metastatic melanoma, lesion > 1\r\n             cm and must be amenable to undergoing serial biopsies through the course of therapy;\r\n             this lesion must not be documented as one of the target lesions\r\n\r\n          -  Patients may have central nervous system (CNS) metastases which have been treated and\r\n             are radiographically stable for at least 4 weeks\r\n\r\n          -  Patients of both genders must practice birth control for four months after receiving\r\n             the preparative regimen (lymphodepletion) and continue to practice birth control\r\n             throughout the study; patients must have a documented negative pregnancy test (urine\r\n             or serum) for women who have menstruated in the past 12 months and without\r\n             sterilization surgery\r\n\r\n          -  Unless surgically sterile by bilateral tubal ligation or vasectomy of partner(s), or\r\n             if the patient is post-menopausal, the patient agrees to continue to use a barrier\r\n             method of contraception throughout the study such as: condom, diaphragm, hormonal,\r\n             intrauterine device (IUD), or sponge plus spermicide; abstinence is an acceptable form\r\n             of birth control\r\n\r\n          -  Pregnancy testing will be performed within 14 days of screening for women of\r\n             childbearing potential (WOCBP); a WOCBP has not undergone a hysterectomy or who has\r\n             not been naturally postmenopausal for at least 12 consecutive months (i.e. who has not\r\n             had menses at any time in the preceding 12 consecutive months)\r\n\r\n          -  Clinical performance status of ECOG 0-1 within 30 days of signing informed consent\r\n\r\n          -  A stress cardiac test (stress thallium, stress multi-gated acquisition scan [MUGA],\r\n             dobutamine echocardiogram or other stress test that will rule out cardiac ischemia)\r\n             within 1 month of lymphodepletion\r\n\r\n          -  12-lead electrocardiogram (EKG) showing no active ischemia and corrected QT (QTc)\r\n             interval less than 480 msec\r\n\r\n          -  Pulmonary function tests (forced expiratory volume in 1 second [FEV1] > 65% or forced\r\n             vital capacity [FVC] > 65% of predicted) within 1 month of lymphodepletion\r\n\r\n          -  Have measurable disease based on RECIST 1.1 and immune related response (irRC)\r\n             criteria\r\n\r\n          -  Absolute neutrophil count (ANC) >= 1,500 /mcL (within 10 days of treatment initiation)\r\n\r\n          -  Platelets >= 100,000 /mcL (within 10 days of treatment initiation)\r\n\r\n          -  Hemoglobin >= 9 g/dL or >= 5.6 mmol/L (within 10 days of treatment initiation)\r\n\r\n          -  Serum creatinine OR measured or calculated creatinine clearance (glomerular filtration\r\n             rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]) =<\r\n             1.5 X upper limit of normal (ULN) OR >= 60 mL/min for subject with creatinine levels >\r\n             1.5 X institutional ULN (within 10 days of treatment initiation)\r\n\r\n          -  Serum total bilirubin =< 1.5 X ULN (within 10 days of treatment initiation) OR\r\n\r\n          -  Direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN (within 10\r\n             days of treatment initiation)\r\n\r\n          -  Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and\r\n             alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X\r\n             ULN or =< 5 X ULN for subjects with liver metastases (within 10 days of treatment\r\n             initiation)\r\n\r\n          -  International normalized ratio (INR) or prothrombin time (PT)/activated partial\r\n             thromboplastin time (aPTT) =< 1.5 X ULN unless subject is receiving anticoagulant\r\n             therapy as long as PT or PTT is within therapeutic range of intended use of\r\n             anticoagulants =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long\r\n             as PT or PTT is within therapeutic range of intended use of anticoagulants\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  TURNSTILE I - SCREENING\r\n\r\n          -  Active systemic infections requiring intravenous antibiotics, coagulation disorders or\r\n             other major medical illnesses of the cardiovascular, respiratory or immune system; PI\r\n             or his designee shall make the final determination regarding appropriateness of\r\n             enrollment\r\n\r\n          -  Primary immunodeficiency and need for chronic steroid therapy, exception: patients on\r\n             chronic physiological dose of steroid equivalent to prednisone < 10 mg/day is allowed\r\n\r\n          -  Patients who are pregnant or nursing\r\n\r\n          -  Presence of a significant psychiatric disease, which in the opinion of the principal\r\n             investigator or his designee, would prevent adequate informed consent\r\n\r\n          -  TURNSTILE II - TREATMENT\r\n\r\n          -  Is currently participating in or has participated in a study of an investigational\r\n             agent or using an investigational device within 4 weeks of the first dose of treatment\r\n\r\n          -  Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any\r\n             other form of immunosuppressive therapy within 7 days prior to initiation of\r\n             lymphodepletion; exception: patients on chronic physiologic dose of steroid equivalent\r\n             to prednisone < 10 mg/day is allowed\r\n\r\n          -  Has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to\r\n             investigational or standard agents administered more than 4 weeks earlier\r\n\r\n          -  Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy\r\n             within 2 weeks prior to lymphodepletion or who has not recovered (i.e., =< grade 1 or\r\n             at baseline) from adverse events due to a previously administered agent\r\n\r\n               -  Note: subjects with =< grade 2 neuropathy, alopecia, hypophysitis stable on\r\n                  physiologic dose of steroid equivalent to prednisone < 10 mg/day, hypothyroidism\r\n                  stable on hormone replacement are an exception to this criterion and may qualify\r\n                  for the study\r\n\r\n               -  Note: if subject received major surgery, they must have recovered adequately from\r\n                  the toxicity and/or complications from the intervention prior to starting therapy\r\n\r\n          -  Has a known additional malignancy that is progressing or requires active treatment;\r\n             exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the\r\n             skin, or in situ cervical cancer that has undergone potentially curative therapy\r\n\r\n          -  Has known active central nervous system (CNS) metastases and/or carcinomatous\r\n             meningitis; subjects with previously treated brain metastases may participate provided\r\n             they are stable (without evidence of progression by imaging for at least four weeks\r\n             prior to the first dose of trial treatment and any neurologic symptoms have returned\r\n             to baseline), have no evidence of new or enlarging brain metastases, and are not using\r\n             steroids for at least 7 days prior to initiation of lymphodepletion\r\n\r\n          -  Has an active autoimmune disease requiring systemic treatment within the past 3 months\r\n             or a documented history of clinically severe autoimmune disease; subjects with\r\n             vitiligo or resolved childhood asthma/atopy would be an exception to this rule;\r\n             subjects that require intermittent use of bronchodilators or local steroid injections\r\n             would not be excluded from the study; subjects with hypothyroidism stable on hormone\r\n             replacement or Sjogren's syndrome will not be excluded from the study; subjects with\r\n             hypophysitis stable on physiologic dose of steroid will not be excluded from the study\r\n\r\n          -  Has evidence of interstitial lung disease or has a history of non-infectious\r\n             pneumonitis that required steroids or current pneumonitis\r\n\r\n          -  Has an active infection requiring systemic therapy\r\n\r\n          -  Has known psychiatric or substance abuse disorders that would interfere with\r\n             cooperation with the requirements of the trial\r\n\r\n          -  Is pregnant or breastfeeding, or expecting to conceive or father children within the\r\n             projected duration of the trial, starting with the pre-screening or screening visit\r\n             through 120 days after the last dose of trial treatment\r\n\r\n          -  Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)\r\n\r\n          -  Has known active hepatitis B (e.g., hepatitis B virus HBsAg surface protein antigen\r\n             [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA]\r\n             [qualitative] is detected)\r\n\r\n          -  Has received a live vaccine within 30 days prior to the first dose of trial treatment\r\n\r\n          -  Any active systemic infections requiring intravenous antibiotics, coagulation\r\n             disorders or other major medical illnesses of the cardiovascular, respiratory or\r\n             immune system, such as abnormal stress thallium or comparable test, myocardial\r\n             infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease; PI or\r\n             his designee shall make the final determination regarding appropriateness of\r\n             enrollment\r\n      ","sponsor":"M.D. Anderson Cancer Center","sponsor_type":"Other","conditions":"Metastatic Melanoma|Stage IIIB Cutaneous Melanoma AJCC v7|Stage IIIC Cutaneous Melanoma AJCC v7|Stage IV Cutaneous Melanoma AJCC v6 and v7","interventions":[{"intervention_type":"Biological","name":"Biological: Aldesleukin","description":"Given IV or SC"},{"intervention_type":"Drug","name":"Drug: Cyclophosphamide","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: Fludarabine Phosphate","description":"Given IVPB"},{"intervention_type":"Other","name":"Other: Laboratory Biomarker Analysis","description":"Correlative studies"},{"intervention_type":"Biological","name":"Biological: Pembrolizumab","description":"Given IV"},{"intervention_type":"Other","name":"Other: Quality-of-Life Assessment","description":"Ancillary studies"},{"intervention_type":"Biological","name":"Biological: Therapeutic Tumor Infiltrating Lymphocytes","description":"Given IV"}],"outcomes":[{"outcome_type":"primary","measure":"Overall response rate in each arm","time_frame":"Up to 5 years","description":"The overall response rate will be computed separately by arm and presented with exact 95% confidence intervals. The overall response rate will be compared between the two treatment arms by using Fisher's exact test. The association between overall response rate and the same covariates will be assessed by using logistic regression."},{"outcome_type":"secondary","measure":"Overall survival","time_frame":"Up to 5 years","description":"The method of Kaplan and Meier will be used to estimate the distributions of overall survival and distributions will be compared between arms by using the log-rank test. Cox regression analysis will be used to assess the association between disease and clinical covariates of interest and overall survival."},{"outcome_type":"secondary","measure":"Progression-free survival","time_frame":"Up to 5 years","description":"The method of Kaplan and Meier will be used to estimate the distributions of progression-free survival, and distributions will be compared between arms by using the log-rank test. Cox regression analysis will be used to assess the association between disease and clinical covariates of interest and progression-free survival."},{"outcome_type":"secondary","measure":"Change in blood and tumor biomarkers","time_frame":"Baseline to up to 5 years","description":"A generalized linear mixed model approach to account for intra-patient correlation will be used to measure blood and tumor biomarkers collected over time."}]}
{"nct_id":"NCT02537678","start_date":"2015-08-01","phase":"N/A","enrollment":183,"brief_title":"Stepped Care for Children After Trauma: Optimizing Treatment","official_title":"Stepped Care for Children After Trauma: Optimizing Treatment","primary_completion_date":"2020-07-23","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-07-23","last_update":"2021-07-26","description":"Children who are exposed to traumatic events are at risk for developing PTSD and other mental health problems. Although effective treatments for childhood PTSD exist, service delivery approaches that are more accessible, efficient, and cost-effective are needed to improve access to evidence-based treatment. The proposed study furthers our pilot work and evaluates an innovative Stepped Care Trauma-Focused Cognitive Behavioral Therapy designed to optimize treatment in community settings and improve the value and efficiency of trauma-focused treatment for children compared to existing approaches, thereby reducing childhood PTSD and related societal impacts and costs.","other_id":"1R01MH107522-01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":4,"maximum_age":12,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Child experienced at least one traumatic event after the age of 36 months\r\n\r\n          2. Child age 4-6 must meet at least four PTSD symptoms and children age 7 to 12 must meet\r\n             at least five PTSD symptoms with at least one symptom in re-experiencing or one\r\n             symptom in avoidance\r\n\r\n          3. At enrollment, the child must be between 4-12 years of age\r\n\r\n          4. The parent/guardian must be willing and able to participate in the treatment and\r\n             complete informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Psychosis, mental retardation, autism spectrum disorder in the child or any condition\r\n             that would limit the caregiver's ability to understand CBT and the child's ability to\r\n             follow instructions\r\n\r\n          2. Parent has had substance use disorder (SUD) within the past 3 months.\r\n\r\n          3. Child or parent is suicidal\r\n\r\n          4. Child or parent is not fluent in English\r\n\r\n          5. Child is currently taking psychotropic medication and is not on a stable medication\r\n             regimen for at least 4 weeks prior to admission to the study. For stimulants or\r\n             benzodiazepines, the medication regimen must be stable for 2 weeks. If appropriate, a\r\n             delayed entry will be allowed so that once a child is on a stable dosage the child may\r\n             be enrolled in the study.\r\n\r\n          6. Child is receiving trauma-focused psychotherapy during study treatment.\r\n\r\n          7. Parent/caregiver who would be treatment participant was the perpetrator, or the child\r\n             was perpetrated by a person who still lives in the home\r\n\r\n          8. Child is having unsupervised face-to-face contact with the identified perpetrator\r\n\r\n          9. Siblings\r\n      ","sponsor":"University of South Florida","sponsor_type":"Other","conditions":"Posttraumatic Stress Disorder","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Stepped Care TF-CBT","description":"Stepped Care TF-CBT: Patients will receive Step One: 3 (1 hr.) in-office therapist-led sessions over 6 weeks, the parent-child workbook (Stepping Together),60, 61 scheduled weekly phone meetings (15 minutes), and information from the Stepping Together website and the National Center for Childhood Traumatic Stress website (via web or paper for those without access). Children who do not meet responder status will receive Step Two: 9 (1.5 hr.) in-office therapist-directed sessions of TF-CBT over 6 to 8 weeks"},{"intervention_type":"Behavioral","name":"Behavioral: Standard TF-CBT","description":"Standard TF-CBT: Patients will receive 12 (1.5 hr.) standard weekly in-office therapist-directed sessions (2 additional weeks allow for scheduling difficulty). TF-CBT includes child, parent and conjoint parent-child sessions addressing the 10 core trauma treatment components of TF-CBT (e.g., parenting skills, affect modulation, cognitive coping, trauma narrative, etc.)."}],"outcomes":[{"outcome_type":"primary","measure":"Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms","time_frame":"Change from baseline in posttraumatic stress symptoms at post treatment and 6 and 12 months","description":"Trauma Symptom Children for Young Children Posttraumatic Stress total score will measure changes in child PTSD symptoms for children ages 4-12. Score ranges from 27 to 108 with higher scores indicating greater posttraumatic stress symptoms."},{"outcome_type":"primary","measure":"Child Sheehan Disability Scale (CSDS) Parent version","time_frame":"Change from baseline impairment at post treatment and 6 and 12 months","description":"The Child Sheehan Disability Scale is a caregiver report to measure childhood impairment. The change in the SCDS-Parent version will be used to measure change in impairment.Scores range from 0 to 50 with higher scores indicating greater impairment."},{"outcome_type":"secondary","measure":"Child Behavior Checklist Internalizing symptoms","time_frame":"Change from baseline in internalizing symptoms at post treatment and 6 and 12 months","description":"Changes in T scores in internalizing symptoms. T scores may range from 33 to 100 with higher T scores indicating greater internalizing symptoms."},{"outcome_type":"secondary","measure":"Child Behavior Checklist Externalizing symptoms","time_frame":"Change from baseline in externalizing symptoms at post treatment and 6 and 12 months","description":"Changes in T scores in externalizing symptoms. T scores range from 33 to 100 with higher T scores indicating greater externalizing problems."},{"outcome_type":"secondary","measure":"Clinical Global Impression-Severity (CGI-S)","time_frame":"Change from baseline in severity at post treatment and 6 and 12 months","description":"The CGI-S is a widely used 7-point rating of severity of psychopathology including. impairment (0=no illness, 6=extremely severe). Changes in ratings will be used to measure change in severity."},{"outcome_type":"secondary","measure":"Clinical Global Impression-Improvement (CGI-I)","time_frame":"Participants will be assessed for treatment improvement at post treatment and 6 and 12 months","description":"The CGI-I modified version, 8-point rating will be used for treatment response. A 1, 2 or 3 will be used to indicate treatment response."},{"outcome_type":"other","measure":"Parenting Stress Scale (PSS)","time_frame":"Change from baseline in parenting stress at post treatment and 6 and 12 months","description":"The PSS scores will be used to measure change in parenting stress. Scores range from 18 to 90 with higher scores indicating higher parenting stress."},{"outcome_type":"other","measure":"Depression, Anxiety and Stress Scale (short form), DASS","time_frame":"Change from baseline in parent depression at post treatment and 6 and 12 months","description":"DAS self-report will be used to measure change in parent depression, Scores range from 0 to 21 with higher scores indicating higher depressive symptoms."},{"outcome_type":"other","measure":"The PTSD Checklist-Civilian (PCL-C)","time_frame":"Change from baseline in parent depression at post treatment and 6 and 12 months","description":"The PCL-C will be used to measure change in parent self-report of PTSD symptom severity. Scores range from 0 to 80 with higher scores indicating greater posttraumatic stress symptoms."}]}
{"nct_id":"NCT02510885","start_date":"2015-07-31","phase":"N/A","enrollment":100,"brief_title":"SD-OCT Angiography","official_title":"Spectral Domain-Optical Coherence Tomography Angiography of Retinal Diseases","primary_completion_date":"2021-10-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-10-31","last_update":"2021-06-18","description":"The objective of this study is to image retinal vascular alterations in patients with retinal disease using the AngioVue OCT-A system and understand the information these images provide. The investigators will image study participants who have retinal diseases with the AngioVue unit (Optovue) and will collect relevant clinical data to understand the nature of the information contained in images obtained on AngioVue. This study being conducted under an abbreviated IDE. The investigators will analyze data using descriptive statistics. Risks related to light exposure will be managed by ensuring that the exposure to the AngioVue light source is well below maximum permissible limits for safe exposure.","other_id":"Pro00063777","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Capable and willing to provide consent\r\n\r\n          -  History of clinically diagnosed retinal diseases, including but not limited to\r\n             age-related macular degeneration, diabetic retinopathy, retinal vein occlusion,\r\n             macular telangiectasias, and diabetic macular edema\r\n\r\n          -  At least 18 years of age\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Unable or unwilling to give consent\r\n\r\n          -  Under 18 years of age\r\n      ","sponsor":"Duke University","sponsor_type":"Other","conditions":"Neovascular Age-related Macular Degeneration|Age-related Macular Degeneration|Diabetic Retinopathy|Retinal Vein Occlusion|Diabetic Macular Edema","interventions":[{"intervention_type":"Device","name":"Device: AngioVue SD-OCT","description":"OCT-A allows noninvasive, high-resolution imaging of the microvasculature of the retina and choroid, without intravenous dye administration. SD-OCT units use the light source used in commercially available and FDA-cleared OCT units on a modified platform. Optovue, Inc. has developed a customized SD-OCT system that implements a novel algorithm, the amplitude-based method of split-spectrum amplitude-decorrelation angiography (SSADA) for OCT-A. This detects motion in the blood vessel lumen by measuring the variation in reflected OCT signal amplitude between consecutive cross-sectional scans. Optovue has integrated the novel SSADA algorithm into their commercially approved RTVue SD-OCT unit for their OCT-A unit, the AngioVue. This unit is being conducted under an abbreviated IDE."}],"outcomes":[{"outcome_type":"primary","measure":"Image Quality","time_frame":"1 year","description":"Assessment of quality of images obtained by SD-OCT Angiography unit."}]}
{"nct_id":"NCT02395861","start_date":"2015-07-31","phase":"N/A","enrollment":400,"brief_title":"Prognosis of Brain Reflexes","official_title":"Evaluation of the Clinical and Electrophysiological Responses of the Brainstem in Patients With Alteration of Consciousness in Relation or Not With Sedation: Prognostic Study of Brain Reflexes","primary_completion_date":"2019-05-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-05-31","last_update":"2019-02-19","description":"Severe diseases in intensive care unit (ICU) patients are associated with a high mortality rate which nevertheless remains difficult to predict. Recently, the abolition of some brainstem reflexes at clinical examination of ICU patients within the first 24 hours after has been shown of prognostic value in ICU patients requiring sedation. Early abolition of the cough reflex was associated with an increase in mortality and that of the oculocephalic reflex was predictive of coma or delirium after sedation has been stopped. A dysfunction of the brainstem may account for these results and be present in other patient subpopulations, particularly those who do not receive iv sedation or the brain injured patients, who were eluded from the previous study. This dysfunction could take place in the muti-organ failure characteristic of the severe ICU patient. On the other hand, a preliminary study performed on somatosensory evoked potentials has shown that a latency of the P14 wave greater than 16 ms between day 1 and day 3 after admission was associated with death at 28 days. The primary goal of this project is to confirm this hypothesis. By studying the clinical and electrophysiological responses of the brainstem in ICU patients, with or without brain injury, with alteration of consciousness in relation or not with sedation. The other objectives are to determine the correlations between neurophysiological clinical neurological, or neuroradiological data with delirium occurrence. The main objective of this study is to determine, in ICU patients with or without brain injury and with alteration of consciousness in relation or not with sedation, if abolition of the cough reflex at Day 1 after admission is predictive of mortality at 28 days, independent from cause for admission and severity.","other_id":"P120915","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adult Medical or surgical, brain-injured or not, patients\r\n\r\n          -  Admitted to the intensive care Unit (ICU)\r\n\r\n          -  Requiring invasive mechanical ventilation for at least 48 hours\r\n\r\n          -  With alteration of consciousness induced by sedatives or not\r\n\r\n          -  Within the 24 hours ( 12) after admission into the ICU\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnancy\r\n\r\n          -  Post anoxic coma\r\n\r\n          -  Brain death\r\n\r\n          -  Pre-existing neurologic disease disturbing the interpretation of the brainstem\r\n             reflexes (Guillain-Barre, myasthenia, gravis, brain tumor, inflammatory or\r\n             degenerating disease of the posterior fossa, acute peripheral neurologic disease)\r\n\r\n          -  Declined participation\r\n      ","sponsor":"Assistance Publique - Hpitaux de Paris","sponsor_type":"Other","conditions":"Adult Patients With Alteration of Consciousness|Admitted Into the Intensive Care Unit (ICU)","interventions":[{"intervention_type":"Other","name":"Other: neuro-electrophysiologic analyses","description":"mismatch negativity (MMN) cognitive evoked potentials (CEP) auditory evoked potentials (AEP)"}],"outcomes":[{"outcome_type":"primary","measure":"Mortality at Day 28","time_frame":"day 28"},{"outcome_type":"secondary","measure":"Neurophysiologic response (P14 latency value greater than 16 ms of the SEP of the median nerve)","time_frame":"day 1 and day 3","description":"P14 latency value greater than 16 ms of the SEP of the median nerve"}]}
{"nct_id":"NCT02532842","start_date":"2015-07-31","enrollment":90,"brief_title":"Non-Interventional Study of Participants With Newly Diagnosed Schizophrenia Treated With Paliperidone Palmitate","official_title":"Paliperidone Palmitate in Early Schizophrenia - A Retrospective, Non-interventional Study of Patients With Newly Diagnosed Schizophrenia Treated With Paliperidone Palmitate Over a 12-Month Period","primary_completion_date":"2015-09-30","study_type":"Observational","rec_status":"Completed","completion_date":"2015-09-30","last_update":"2015-11-03","description":"The primary objective of this study is to explore hospitalization (number, length and reasons for psychiatric hospitalizations) in young, adult, newly diagnosed schizophrenia participants during the first 12 months of treatment with once monthly paliperidone palmitate in naturalistic clinical settings.","other_id":"CR105892","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":29,"population":"Participants with Schizophrenia (according to ICD 10 or DSM IV) who were recently diagnosed\r\n        (<= 1 year [y] before start of PP treatment) with >= 18 y and <=29 y of age and who\r\n        received PP for at least 12 months prior to study start of the study (retrospective\r\n        cohort).","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Participant must be a man or woman aged at least 18 years but not more than 29 years\r\n             at the time of the first injection of paliperidone palmitate\r\n\r\n          -  Participant must have a documented diagnosis of schizophrenia according to either\r\n             Tenth Revision of the International Classification of Diseases and Related Health\r\n             Problems (ICD 10) or Diagnostic and Statistical Manual of Mental Disorders, Fourth\r\n             Edition (DSM 4)\r\n\r\n          -  Participant's first psychotic episode suggestive of schizophrenia must have been\r\n             clinically evident not longer than 1 year prior to the first injection of paliperidone\r\n             palmitate\r\n\r\n          -  Participant must have documentation (medical records) of at least 12 months (365 +/-\r\n             31 days) continuous treatment with paliperidone palmitate administered for the first\r\n             time as part of clinical practice. This documentation must have been completed in the\r\n             participant's records before the initiation of the study site\r\n\r\n          -  Participant must have initiated paliperidone palmitate treatment after the launch date\r\n             (ie, commercial availability) of paliperidone palmitate at his/her respective site\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Participant has either an ICD 10 or DSM 4 axis I diagnosis other than schizophrenia\r\n\r\n          -  Participant was diagnosed with alcohol or drug dependence (except for nicotine and\r\n             caffeine dependence) according to either ICD 10 or DSM 4 criteria within 1 month prior\r\n             to initiation of paliperidone palmitate treatment or during the 12 month documentation\r\n             period\r\n\r\n          -  Participant was treated with any long acting injectable antipsychotic prior to\r\n             paliperidone palmitate initiation or with a long-acting injectable antipsychotic other\r\n             than paliperidone palmitate during the 12 month documentation period\r\n\r\n          -  Participant received an investigational drug (including investigational vaccines) or\r\n             used an invasive investigational medical device within 30 days prior to paliperidone\r\n             palmitate initiation or during the 12 month documentation period\r\n\r\n          -  Participant participated in an interventional or a non-interventional clinical study\r\n             during the 12 month documentation period\r\n      ","sponsor":"Janssen Pharmaceutica N.V., Belgium","sponsor_type":"Industry","conditions":"Schizophrenia","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Number of Hospitalizations","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Number of Treatment Patterns of paliperidone palmitate as measured by patient records","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Treatment response Based on clinical illness, symptom severity and measurements of functioning Score","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Parameters of Psychosocial Functioning based on questionnaire","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Medical Resource Utilization","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Psychiatric hospitalizations preceding the first paliperidone palmitate injection","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Number of Participants with Adverse Events","time_frame":"12 months"}]}
{"nct_id":"NCT02441114","start_date":"2015-07-31","phase":"Phase 1","enrollment":10,"brief_title":"Pharmacokinetics of Co-administration of Seretide 250 Diskus (HCP0910) and Spiriva Capsule for Inhalation (HGP1011)","official_title":"A Pilot Study to Investigate Pharmacokinetic Characteristics After Co-administration of HCP0910 and HGP1011","primary_completion_date":"2015-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-10-31","last_update":"2017-01-11","description":"This pilot study was designed to evaluate the pharmacokinetic characteristics of fluticasone, salmeterol, and tiotropium after co-administration of HCP 0910 (Seretide 250 diskus) and HGP1011 (Spiriva capsule for inhalation) which are prescribed concomitantly for the patients with chronic obstructive pulmonary disease (COPD).","other_id":"HM_COPD_PILOT","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Screening","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":19,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age between 19 to 45, healthy male subjects (at screening)\r\n\r\n          -  Body weight between 55kg - 90kg, BMI (Body Mass Index) between 18.0 - 27.0\r\n\r\n          -  Volunteer who totally understands the progress of this clinical trials, make decision\r\n             by his free will, and signed a consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Volunteer who has past or present history of any diseases such as liver including\r\n             hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine,\r\n             hematooncology, cardiology, mental disorder\r\n\r\n          -  Volunteer who had drug(Aspirin, antibiotics) hypersensitivity reaction\r\n\r\n          -  Subject who already participated in other trials in 3 months\r\n\r\n          -  Subject who had whole blood donation in 2 months, or component blood donation in 1\r\n             months or transfusion\r\n      ","sponsor":"Seoul National University Hospital","sponsor_type":"Other","conditions":"Pulmonary Disease, Chronic Obstructive","interventions":[{"intervention_type":"Drug","name":"Drug: HCP0910 and HGP1011","description":"Inhalation of HCP0910 (Seretide 250 diskus (Fluticasone Propionate 250 mcg/Salmeterol Xinafoate 72.5 mcg)) and HGP1011 (Spiriva capsule for inhalation (Micronized Tiotropium Bromide Monohydrate 22.5 mcg))"}],"outcomes":[{"outcome_type":"primary","measure":"Area Under the Concentration Versus Time Curve (AUClast)","time_frame":"Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose","description":"Area under the concentration of fluticasone versus time curve from the time of dosing to the last measurable concentration"},{"outcome_type":"secondary","measure":"Time to Maximum Concentration (Tmax)","time_frame":"Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose","description":"Time to maximum concentration of fluticasone"},{"outcome_type":"secondary","measure":"Maximum Observed Concentration (Cmax)","time_frame":"Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose","description":"Maximum observed concentration of fluticasone"}]}
{"nct_id":"NCT02509728","start_date":"2015-07-31","phase":"N/A","enrollment":24,"brief_title":"Metabolic Effects of Choline and Docosahexaenoic Acid Supplementation in Preterm Infants","official_title":"Nahrungsergnzung Mit Cholin- Und Docosahexaensure Bei Sehr Unreifen Frhgeborenen","primary_completion_date":"2017-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-12-31","last_update":"2018-05-15","description":"To explore the effects of enteral choline and DHA supplementation on plasma choline and DHA-PC concentrations and metabolism, this randomized controlled study will assign 40 preterm infants to 1 of 4 groups: standard care, choline supplementation, DHA supplementation, and choline and DHA supplementation. After 7 days of supplementation, a single dose of stable isotope labelled choline will be administered and the kinetics of newly synthesized DHA-PC determined to assess plasma levels, uptake and distribution of choline and DHA. This study is designed to inform larger studies evaluating this approach of enteral co-application of choline and DHA on clinical important outcomes.","other_id":"Choline and DHA for Preemies 2","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"All","maximum_age":0.16667,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  preterm infants with a gestational age at birth between 24 and 32 weeks\r\n\r\n          -  on almost complete enteral feeding (>75% of total fluid intake)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  insufficient enteral intake,\r\n\r\n          -  gastrointestinal disease,\r\n\r\n          -  missing parental consent\r\n      ","sponsor":"University Hospital Tuebingen","sponsor_type":"Other","conditions":"Infant, Premature","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: choline supplementation","description":"in addition to standard nutrition: enteral supplementation with 30mg/kg choline chloride for 10 days"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: DHA supplementation","description":"in addition to standard nutrition: enteral supplementation with 60mg/kg DHA for 10 days"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: standard nutrition","description":"standard nutrition"}],"outcomes":[{"outcome_type":"primary","measure":"plasma concentrations of choline","time_frame":"following 7 days of supplementation"},{"outcome_type":"secondary","measure":"de-novo DHA-phosphatidylcholine synthesis","time_frame":"following 7 days of supplementation at 12hours after D9-choline administration"},{"outcome_type":"secondary","measure":"DHA-phosphatidylcholine turnover","time_frame":"following 7.5 days of supplementation, from 12hours to 60 hours after D9-choline administration"},{"outcome_type":"secondary","measure":"fractions and concentrations of molecular species of phosphatidylcholine","time_frame":"baseline and following 7.5 and 10 days of supplementation"},{"outcome_type":"secondary","measure":"plasma concentrations of choline","time_frame":"baseline and following 7.5 and 10 days of supplementation"},{"outcome_type":"secondary","measure":"Plasma concentrations of betaine (a metabolite of choline)","time_frame":"baseline and following 7.5 and 10 days of supplementation"},{"outcome_type":"secondary","measure":"Plasma concentrations of dimethylglycine (a metabolite of choline)","time_frame":"baseline and following 7.5 and 10 days of supplementation"},{"outcome_type":"secondary","measure":"Plasma concentrations of trimethylamineoxide (TMAO, a metabolite of choline)","time_frame":"baseline and following 7.5 and 10 days of supplementation"}]}
{"nct_id":"NCT02408835","start_date":"2015-07-31","phase":"N/A","enrollment":22,"brief_title":"Negative Pressure Wound Therapy in Groin Dissection","official_title":"A Randomised Controlled Trial Comparing PICO Single Use Negative Pressure Wound Therapy System (Smith & Nephew Healthcare Limited, UK) to Conventional Wound Care Following Inguinal Lymphadenectomy for Metastatic Cutaneous Malignancy","primary_completion_date":"2019-07-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-07-31","last_update":"2015-04-06","description":"This study investigates the use of a negative pressure wound therapy device (PICO, Smith & Nephew Healthcare, UK) on clean, closed surgical wounds, in patients who are undergoing inguinal lymphadenectomy for metastatic carcinoma of cutaneous origin.","other_id":"NPWT/14/1.0","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically- or cytologically-proven inguinal lymph node metastases from neoplasm\r\n             of cutaneous origin\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  inability to give informed consent for participation\r\n      ","sponsor":"South Eastern Health and Social Care Trust","sponsor_type":"Other","conditions":"Neoplasm Metastasis|Secondary Malignant Neoplasm of Lymph Node|Non-healing Surgical Wound (Disorder)|Skin Neoplasms","interventions":[{"intervention_type":"Device","name":"Device: PICO","description":"Negative pressure wound therapy device for closed surgical wounds."}],"outcomes":[{"outcome_type":"primary","measure":"Time to wound healing","time_frame":"From date of surgery until epithelial integrity is restored at the surgical site. Assessed at least weekly until wound is healed, up to 20 weeks after surgery","description":"Determination of wound healing"},{"outcome_type":"secondary","measure":"Wound infection As defined by Comprehensive Complication Index (CCI)","time_frame":"From date of surgery until wound is healed (epithelial integrity restored at surgical site), up to 20 weeks after surgery.","description":"As defined by Comprehensive Complication Index (CCI)"},{"outcome_type":"secondary","measure":"Lymphoedema (Limb volume measurements)","time_frame":"From date of surgery up to one year post-operatively.","description":"Limb volume measurements at 3, 6, 9 and 12 months"},{"outcome_type":"secondary","measure":"Need for further surgical interventions to achieve wound healing","time_frame":"From date of surgery until wound is healed, up to 20 weeks after surgery."},{"outcome_type":"secondary","measure":"Scar appearance (POSAS)","time_frame":"From date of surgery up to one year post-operatively.","description":"POSAS at 3,6, 9 and 12 months"},{"outcome_type":"secondary","measure":"Patient reported outcomes (qualitative interview)","time_frame":"From date of surgery to six months post-operatively.","description":"Semi-structured qualitative interviews in first week after surgery, and at 6 months after surgery."}]}
{"nct_id":"NCT03464968","start_date":"2015-07-29","phase":"Phase 2","enrollment":120,"brief_title":"mFOLFOX vs. mFOLFIRI in Advanced or Recurrent Biliary Tract Cancer Refractory to First Line","official_title":"A Randomized Phase II Study of mFOLFOX vs. mFOLFIRI in Advanced or Recurrent Biliary Tract Cancer Refractory to First Line Gemcitabine Plus Cisplatin","primary_completion_date":"2020-02-10","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-07-25","last_update":"2020-12-02","description":"In second line with advanced or recurrent biliary tract cancer refractory to first line gemcitabine plus cisplatin, efficacy of mFOLFOX vs. mFOLFIRI will be evaluated at randomized phase 2 trial.","other_id":"biliary second line","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  20 years and older\r\n\r\n          -  pathologically confirmed biliary tract cancer (adenocarcinoma) including intrahepatic,\r\n             extrahepatic, gallbladder, ampulla of vater\r\n\r\n          -  initially inoperable or recurrent\r\n\r\n          -  ECOG 0-2\r\n\r\n          -  as first line chemotherapy, refractory to gemcitabine/cisplatin (at least one cycle\r\n             applied)\r\n\r\n          -  evaluable or measurable lesion\r\n\r\n          -  within 1 week, patients who meet below laboratory results (hemoglobin >9.0 g/dL,\r\n             neutrophil >1000/uL, platelet> 75000/uL, serum creatinine < UNL * 1.5, AST/ALT <\r\n             UNL*3, total bilirubin < UNL*1.5 (available for biliary drainage)\r\n\r\n          -  patients who have ability to understand the purpose, benefit and harm for this trial,\r\n             and the right to withdraw this trial in any time without any disadvantage\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  other cancer history\r\n\r\n          -  pregnant or lactating\r\n\r\n          -  uncontrolled medical condition such as infection or cardiovascular disease\r\n\r\n          -  hypersensitivity to experimental drugs\r\n\r\n          -  uncontrolled CNS metastasis, psychologic problem\r\n      ","sponsor":"Seoul National University Bundang Hospital","sponsor_type":"Other","conditions":"Biliary Cancer Metastatic","interventions":[{"intervention_type":"Drug","name":"Drug: Oxaliplatin,5FU, leucovorin","description":"mFOLFOX"},{"intervention_type":"Drug","name":"Drug: irinotecan,5FU, leucovorin","description":"mFOLFIRI"}],"outcomes":[{"outcome_type":"primary","measure":"6 months overall survival rate","time_frame":"6months","description":"at 6 months from intervention treatment, overall survival rate"},{"outcome_type":"secondary","measure":"response rate","time_frame":"6months","description":"complete response, partial response"},{"outcome_type":"secondary","measure":"disease control rate","time_frame":"6months","description":"complete response, partial response, stable disease"},{"outcome_type":"secondary","measure":"progression free survival","time_frame":"6months","description":"from treatment start to progression or any cause of death"},{"outcome_type":"secondary","measure":"Number of Participants With Treatment-Related Adverse Events as Assessed by NCI CTC version 4.0","time_frame":"6months","description":"percentage of all patients"}]}
{"nct_id":"NCT02393794","start_date":"2015-07-17","phase":"Phase 1/Phase 2","enrollment":54,"brief_title":"Cisplatin Plus Romidepsin & Nivolumab in Locally Recurrent or Metastatic Triple Negative Breast Cancer (TNBC)","official_title":"Phase I/II Study of Cisplatin Plus Romidepsin and Nivolumab in Metastatic Triple Negative Breast Cancer or BRCA Mutation-Associated Locally Recurrent or Metastatic Breast Cancer","primary_completion_date":"2021-10-31","study_type":"Interventional","rec_status":"Suspended","completion_date":"2021-10-31","last_update":"2020-11-06","description":"Study combination use of cisplatin plus romidepsin and nivolumab in metastatic triple negative breast cancer (TNBC) or BRCA mutation-associated locally recurrent or metastatic breast cancer","other_id":"IIT-2014-CISRomiNivoTNBC","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subjects must meet at least one of the following two criteria:\r\n\r\n               1. Histologically proven TNBC\r\n\r\n               2. Confirmed germline BRCA1 or BRCA2 mutation, regardless of subtype of breast\r\n                  cancer\r\n\r\n          -  Breast cancer that is either stage III disease not amenable to curative therapy or\r\n             stage IV\r\n\r\n          -  Have at least one measurable lesion of  2 cm by conventional methods or  1 cm on\r\n             spiral CT\r\n\r\n          -  No limit to prior therapy for metastatic breast cancer. Prior treatment with cisplatin\r\n             is excluded, unless prior cisplatin treatment was given in the neo/adjuvant setting.\r\n             All other platinum compounds are allowed as long as it has been 6 months since last\r\n             platinum exposure.\r\n\r\n          -  All patients should have received at least one line of chemotherapy in either the\r\n             advanced or adjuvant setting and hormonal therapy (where appropriate). Participants\r\n             who have previously been treated with endocrine therapy only, and later develop triple\r\n             negative disease are eligible as long as they have had one line of chemotherapy in\r\n             either the advanced or adjuvant setting.\r\n\r\n          -  Eastern Oncology Cooperative Group (ECOG) Performance status of  2\r\n\r\n          -  Laboratory values as follows:\r\n\r\n               -  absolute neutrophil count  1,500/uL (microliter)\r\n\r\n               -  platelets  100,000/uL (no transfusion allowed within 2 weeks)\r\n\r\n               -  hemoglobin > 9 g/dL (which may be reached by transfusion)\r\n\r\n               -  total bilirubin within normal range or  1.5 x IULN (Institutional Upper Limit of\r\n                  Normal) if liver metastases\r\n\r\n               -  total bilirubin  3.0 x IULN with direct bilirubin within normal range in\r\n                  subjects with Gilbert's Syndrome\r\n\r\n               -  aspartate aminotransferase (AST) (SGOT) /Alanine transaminase (ALT) (SPGT)  2.5\r\n                  x IULN or  5 x IULN if liver metastases\r\n\r\n               -  Serum creatinine  1.5 x IULN\r\n\r\n               -  International Normalized Ratio (INR)  1.5\r\n\r\n               -  Serum potassium > 3.8 mmol/L\r\n\r\n               -  Serum magnesium >1.8 mg/dL\r\n\r\n          -  IV bisphosphonate and denosumab for bony metastatic disease is allowed\r\n\r\n          -  Radiation to bony metastases is allowed  14 days before starting study treatment\r\n\r\n          -  Subjects with previously treated brain metastasis who are free of central nervous\r\n             system (CNS) symptoms and are  14 days from treatment of brain metastasis are\r\n             eligible.\r\n\r\n          -  Women of child bearing potential and their partners must use contraception prior to\r\n             study entry, continuing for 5 months after treatment.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subject has received any anti-cancer therapy including chemotherapy, immunotherapy,\r\n             biologic, targeted therapy, or any investigational therapy within either 14 days or 5\r\n             half-lives (whichever is shorter), prior to study drug administration.\r\n\r\n          -  Subjects who have not recovered to within one grade level (not to exceed Grade 2) of\r\n             their baseline following a significant adverse event or toxicity attributed to prior\r\n             treatment.\r\n\r\n          -  Other medical or psychiatric disorder placing the subject at undue risk for treatment\r\n             complications\r\n\r\n          -  Subject is pregnant or lactating\r\n\r\n          -  Subject has previously been treated with a Histone deacetylases (HDAC) inhibitor, PD-1\r\n             inhibitor, PD-L1 inhibitor, PD-L2 inhibitor, CTLA-4 inhibitor, or any other antibody\r\n             or drug specifically targeting T-cell costimulation or immune checkpoint pathways\r\n\r\n          -  Subject tests positive for hepatitis B or C indicating acute or chronic infection\r\n\r\n          -  Subject has known history of testing positive for HIV or AIDS\r\n\r\n          -  Subject has inflammatory breast cancer\r\n\r\n          -  Subject has a known hypersensitivity to any of the excipients of nivolumab, cisplatin\r\n             or romidepsin\r\n\r\n          -  Subject has a concurrent malignancy or malignancy within 3 years of study enrollment\r\n             (with the exception of adequately treated, basal or squamous cell carcinoma,\r\n             non-melanomatous skin cancer or curatively resected cervical cancer or prior\r\n             ovarian/breast cancer in patients with BRCA associated breast cancer).\r\n\r\n          -  Subject is classified into Child-Pugh Class C\r\n\r\n          -  Subject has active, uncontrolled infection\r\n\r\n          -  Subject has symptomatic/untreated CNS disease\r\n\r\n          -  Subject has an active, known or suspected autoimmune disease. Subjects are permitted\r\n             to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due\r\n             to autoimmune condition only requiring hormone replacement, psoriasis not requiring\r\n             systemic treatment, or conditions not expected to recur in the absence of an external\r\n             trigger.\r\n\r\n          -  Subject has active cardiac disease or a history of cardiac dysfunction, including:\r\n\r\n               -  Congenital long QT syndrome\r\n\r\n               -  Corrected QT interval (QTc) interval  500 ms on the screening ECG (using the\r\n                  corrected QT interval to Fridericia's formula [QTcF])\r\n\r\n               -  Myocardial infarction within 6 months of Cycle 1 Day 1 (C1D1).\r\n\r\n               -  Other significant ECG abnormalities including 2nd degree atrio-ventricular (AV)\r\n                  block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50\r\n                  beats/min)\r\n\r\n               -  Symptomatic coronary artery disease (CAD)\r\n\r\n               -  An ECG recorded at screening showing evidence of cardiac ischemia (ST depression\r\n                  of  2 mm, measured from isoelectric line to the ST segment).\r\n\r\n               -  Congestive heart failure (CHF) that meets New York Heart Association (NYHA) Class\r\n                  II to IV definitions and/or ejection fraction < 40% by Multi Gated Acquisition\r\n                  Scan (MUGA) or < 50% by echocardiogram and/or MRI\r\n\r\n               -  A known history of sustained ventricular tachycardia (VT), ventricular\r\n                  fibrillation (VF), Torsade de Pointes, or cardiac arrest unless currently\r\n                  addressed with an automatic implantable cardioverter defibrillator (AICD)\r\n\r\n               -  Hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or\r\n                  other causes\r\n\r\n               -  Uncontrolled hypertension, i.e., blood pressure (BP) of  160/95; subjects who\r\n                  have a history of hypertension controlled by medication must be on a stable dose\r\n                  (for at least one month) and meet all other inclusion criteria\r\n\r\n               -  Any cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable\r\n                  doses of beta-blockers)\r\n\r\n               -  Subjects taking drugs leading to significant QT prolongation\r\n\r\n               -  Concomitant use of CYP3A4 inhibitors\r\n\r\n          -  Subject has had major surgery within 14 days prior to starting study drug or has not\r\n             recovered from major side effects\r\n\r\n          -  Subject is currently receiving or has received systemic corticosteroids  2 weeks\r\n             prior to starting study drug or who have not fully recovered from side effects of such\r\n             treatment. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily\r\n             prednisone equivalents are permitted in the absence of active autoimmune disease.\r\n\r\n          -  Subject is currently receiving treatment with drugs known to be moderate or strong\r\n             inhibitors or inducers of isoenzyme CYP3A. The subject must have discontinued strong\r\n             inducers for at least one week and must have discontinued strong inhibitors before the\r\n             start of treatment.\r\n\r\n          -  Subject is currently receiving warfarin or other coumarin derived anti-coagulant for\r\n             treatment. Therapy with heparin, low molecular weight heparin (LMWH), Factor Xa or\r\n             fondaparinux is allowed.\r\n\r\n          -  Subjects with baseline peripheral neuropathy that exceeds Grade 1.\r\n      ","sponsor":"Priyanka Sharma","sponsor_type":"Other","conditions":"Triple-Negative Breast Cancer|Breast Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Romidepsin","description":"Histone deacetylase inhibitor"},{"intervention_type":"Drug","name":"Drug: Cisplatin","description":"Platinum compound"},{"intervention_type":"Drug","name":"Drug: Nivolumab","description":"Monoclonal antibody, checkpoint inhibitor"}],"outcomes":[{"outcome_type":"primary","measure":"Phase I: Recommended Phase II Dose of romidepsin in combination with cisplatin","time_frame":"12 months"},{"outcome_type":"primary","measure":"Phase II: Objective response rate of treated subjects according to RECIST v1.1 criteria","time_frame":"24 months"},{"outcome_type":"secondary","measure":"Phase II: Clinical Benefit Rate at 16 weeks of study treatment for subjects treated at the recommended phase II dose of romidepsin plus cisplatin and nivolumab","time_frame":"24 months"},{"outcome_type":"secondary","measure":"Pharmacokinetics - romidepsin plasma concentration vs time profile when given with cisplatin and nivolumab","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Pharmacokinetics - cisplatin plasma concentration vs time profile when given with romidepsin","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Median Progression-Free Survival and Overall Survival","time_frame":"36 months"}]}
{"nct_id":"NCT03220412","start_date":"2015-07-15","phase":"N/A","enrollment":104,"brief_title":"Viewing Movie Violence & Interest in Guns","official_title":"Exposure to Gun Violence in Movies Increases Interest in Real Guns","primary_completion_date":"2016-01-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-01-01","last_update":"2019-06-03","description":"More American children die by accidental gun use than children in other developed countries. One factor that can influence children's interest in guns is exposure to media containing guns. The objective of this study is to test whether children who see a movie containing guns will handle a real gun longer and will pull the trigger more times than children who see the same movie without guns.","other_id":"2013B0542-3","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"Single","intervention_model_description":"Participants are randomly assigned to watch a movie containing guns, or a movie not containing guns.","sampling_method":"","gender":"All","minimum_age":8,"maximum_age":12,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Age 8-12yrs, had not participated in study prior, was able to schedule participation with a\r\n        known peer (8-12yo).\r\n\r\n        Exclusion Criteria:\r\n\r\n        Younger than 8yo, older than 12yo, had participated in study prior, could not schedule\r\n        participation with a known peer (8-12yo)\r\n      ","sponsor":"Ohio State University","sponsor_type":"Other","conditions":"Psychology, Social|Adolescent Behavior","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Movies with Guns","description":"Participants in this arm viewed movies (National Treasure, The Rocketeer) without guns. The movies, rated PG, were edited to remove guns from the scenes"}],"outcomes":[{"outcome_type":"primary","measure":"Trigger Pulls","time_frame":"20 minutes after intervention","description":"The adjusted median of the number of trigger pulls per child. These data refer to the reduced Generalized Estimating Equation model for the two conditions. This model included participant gender and condition, bu not any of the other control variables."},{"outcome_type":"primary","measure":"Seconds Holding Gun","time_frame":"20 minutes after intervention","description":"Number of seconds participant held gun"}]}
{"nct_id":"NCT02471326","start_date":"2015-07-13","phase":"Phase 1","enrollment":10,"brief_title":"VRC-HIVMAB060-00-AB (VRC01) in People With Chronic HIV Infection Undergoing Analytical Treatment Interruption","official_title":"An Exploratory, Open-Label Study of VRC-HIVMAB060-00-AB (VRC01) in Subjects With Chronic HIV Infection Undergoing Analytical Treatment Interruption","primary_completion_date":"2017-04-07","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-04-07","last_update":"2017-10-31","description":"Background: - A combination of daily drugs (called cART) can keep human immunodeficiency virus (HIV) very low for a long time. But cART can lose effectiveness and cause permanent side effects. If treatment stops, HIV levels go up again. Researchers want to see if a new product can control HIV levels when a person is off cART. Objective: - To see if the new product VRC01 is safe and can control the HIV level in the blood when a person is not taking cART. Eligibility: - Adults ages 18-65 with HIV who are willing to interrupt their treatment for at least 24 weeks. Design: - Participants will be screened with: - Physical exam - Medical history - Heart tests - Blood and urine tests. - Their HIV drugs may be switched. They will keep taking them until a few days after Visit 1. - Visit 1: Repeat screening procedures. - Participants will also have genetic testing and leukapheresis. For this, blood will be removed through a needle in one arm and circulated through a machine that removes white blood cells. The rest of the blood is returned through a needle in the other arm. - They will get the first study drug dose through a thin tube in an arm vein for about 1 hour. - For 24 weeks, participants will have 16 visits. They will have blood drawn every visit. At some visits they will repeat the screening procedures and get another VRC01 dose. They may have another leukapheresis. - Four weeks after the last dose, participants will restart their cART. For 20 weeks, they will have monthly visits to repeat the screening procedures and discuss new symptoms.","other_id":"150140","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        -  INCLUSION CRITERIA\r\n\r\n               1. Age 18-65 years old.\r\n\r\n               2. HIV-1 infection and clinically stable.\r\n\r\n               3. In general good health and with an identified primary health care provider for\r\n                  medical management of HIV infection and willing to maintain a relationship with a\r\n                  primary health care provider for medical management of HIV infection while\r\n                  participating in the study.\r\n\r\n               4. CD4+ cell count >450 cells/mm^3 at screening.\r\n\r\n               5. Documentation of continuous cART treatment with suppression of plasma viral level\r\n                  below the limit of detection for greater than or equal to 3 years. Subjects with\r\n                  blips (i.e., detectable viral levels on cART) prior to screening may be included\r\n                  provided they satisfy the following criteria:\r\n\r\n                    1. The blips are <400 copies/mL, and\r\n\r\n                    2. Succeeding viral levels return to levels below the limit of detection on\r\n                       subsequent testing.\r\n\r\n               6. Willingness to undergo ATI.\r\n\r\n               7. Laboratory values within pre-defined limits at screening:\r\n\r\n                    1. Absolute neutrophil count >1,000/mm^3.\r\n\r\n                    2. Hemoglobin levels >10.0 g/dL for men and >9.0 g/dL for women.\r\n\r\n                    3. Platelet count >100,000/mm^3.\r\n\r\n                    4. Prothrombin time (PT) and partial thromboplastin time (PTT) <1.5 upper limit\r\n                       of normal (ULN).\r\n\r\n                    5. Estimated or a measured creatinine clearance rate of greater than or equal\r\n                       to 50 mL/min as determined by the NIH Clinical Center laboratory.\r\n\r\n                    6. AST and ALT levels of <2.5 x ULN.\r\n\r\n               8. Willingness to have samples stored for future research.\r\n\r\n        Reproductive Risks\r\n\r\n        Contraception: The effects of VRC01 on the developing human fetus are unknown. For this\r\n        reason, men and women of childbearing potential must agree to use adequate pregnancy\r\n        prevention per the investigator. This includes highly reliable established lifestyle of\r\n        complete abstinence of potentially reproductive sexual activity, or use of BOTH a long term\r\n        hormonal or barrier (e.g. implant, depot injection, IUD in female participant or female\r\n        partner of participant) method of contraception that is fully effective prior to dosing,\r\n        COMBINED WITH a barrier method (male or female condom) for all potentially reproductive\r\n        sexual activity. Pregnancy prevention must be maintained as effective and practiced\r\n        continuously for the duration of study participation. Females of childbearing-age must have\r\n        a negative pregnancy test result prior to receiving VRC01. During the course of the study,\r\n        if a female participant, or the partner of a male participant suspects or in fact becomes\r\n        pregnant, the effected participant should inform the study staff immediately, as well as\r\n        the woman's primary care physician. Subjects must use safe sex practices during the trial,\r\n        and particularly during the ATI phase, when risk of transmission of HIV may be increased.\r\n\r\n          -  EXCLUSION CRITERIA\r\n\r\n               1. Chronic hepatitis B, as evidenced by a positive test for hepatitis B surface\r\n                  antigen (HBsAg), or chronic hepatitis C virus (HCV) infection, as evidenced by a\r\n                  positive test for HCV RNA. Subjects with a positive test for HCV antibody and a\r\n                  negative test for HCV RNA are eligible.\r\n\r\n               2. Documented virologic failure to >1 cART regimen.\r\n\r\n               3. HIV immunotherapy or vaccine(s) received within 1 year prior to screening.\r\n\r\n               4. Any licensed or experimental non-HIV vaccination (e.g., hepatitis B, influenza,\r\n                  pneumococcal polysaccharide) received within 2 weeks prior to study enrollment.\r\n\r\n               5. Receipt of other investigational study agent within 28 days of enrollment.\r\n\r\n               6. Any active malignancy that may require systemic chemotherapy or radiation\r\n                  therapy.\r\n\r\n               7. Systemic immunosuppressive medications received within 3 months prior to\r\n                  enrollment (Not excluded: corticosteroid nasal spray or inhaler; topical\r\n                  corticosteroids for mild, uncomplicated dermatitis; or oral/parenteral\r\n                  corticosteroids administered for non-chronic conditions not expected to recur\r\n                  [length of therapy less than or equal to 10 days, with completion in greater than\r\n                  or equal to 30 days prior to enrollment]).\r\n\r\n               8. History or other clinical evidence of:\r\n\r\n                    1. Significant or unstable cardiac disease (e.g., angina, congestive heart\r\n                       failure, recent myocardial infarction).\r\n\r\n                    2. Severe illness, malignancy, immunodeficiency other than HIV, or any other\r\n                       condition that, in the opinion of the investigator, would make the subject\r\n                       unsuitable for the study.\r\n\r\n               9. Active drug or alcohol use or any other pattern of behavior that, in the opinion\r\n                  of the investigator, would interfere with adherence to study requirements.\r\n\r\n              10. Breast-feeding.\r\n      ","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","sponsor_type":"NIH","conditions":"HIV","interventions":[{"intervention_type":"Biological","name":"Biological: VRC-HIVMAB060-00-AB (VRC01)","description":"A potent HIV-specific monoclonal antibody"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Grade 3 or Higher Adverse Events","time_frame":"From the start of the initial infusion until up to 48 weeks.","description":"The primary endpoint was the number of grade 3 or higher adverse events, including serious adverse events, that were possibly related to VRC-HIVMAB060-00-AB (VRCO1)."},{"outcome_type":"secondary","measure":"Subjects Who Met Criteria to Restart Antiretroviral Therapy","time_frame":"From Day 3 post initial infusion until up to 28 weeks.","description":"The secondary endpoint was the number of subjects who met protocol defined virologic (sustained HIV RNA >1000 copies/mL by Abbott HIV RTPCR at 2 consecutive visits), immunologic (a confirmed >30% decline in CD4 cell count or an absolute CD4 cell count < 350 cells/mm3), or clinical criteria (HIV-related symptoms) to discontinue VRC01 infusions and restart Antiretroviral Therapy (ART)."}]}
{"nct_id":"NCT02485405","start_date":"2015-06-30","enrollment":45,"brief_title":"Gut Permeability and Stress","official_title":"Gut Permeability in Volunteers Participating in a Stress Test","primary_completion_date":"2017-09-30","study_type":"Observational","rec_status":"Completed","completion_date":"2017-09-30","last_update":"2017-09-07","description":"The purpose of this study is to analyse gut permeability and stress.","other_id":"SP15_CarolineLinninge","observational_model":"Cohort","time_perspective":"Other","sampling_method":"Probability Sample","gender":"Male","minimum_age":19,"maximum_age":35,"population":"Healthy men aged 19-35 years old","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Man, 19-35 years old\r\n\r\n          -  Healthy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Psychological disorders\r\n\r\n          -  Use of antibiotics or other drugs\r\n      ","sponsor":"Lund University","sponsor_type":"Other","conditions":"Stress","interventions":[{"intervention_type":"Other","name":"Other: Trier social stress test","description":"Volunteers perform Trier social stress test"}],"outcomes":[{"outcome_type":"primary","measure":"gut permeability (marker measured in plasma/serum) in healthy young men participating in Trier social stress test","time_frame":"Volunteers will be followed by one hour after Trier social stress test"}]}
{"nct_id":"NCT02639507","start_date":"2015-06-30","enrollment":40,"brief_title":"International Consortium Investigating Early Vitrectomy in Diabetic Macular Edema Patients","official_title":"International Consortium Investigating Early Vitrectomy in Diabetic Macular Edema Patients - the ICV-DME Study","primary_completion_date":"2020-03-31","study_type":"Observational","rec_status":"Completed","completion_date":"2020-03-31","last_update":"2020-03-26","description":"The purpose of this research is to evaluate the effectiveness of vitrectomy for the treatment of diabetic macular edema. Diabetes is known to cause retinal blood vessels to leak, leading to swelling of the central retina (macula), and decreased vision. Removing the vitreous gel with vitrectomy surgery is known to decrease the swelling caused by diabetes. Diabetic retinopathy is often treated with laser or injections of medicine in to the eye.","other_id":"14-008884","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Eligible patients will have the following characteristics:\r\n\r\n          -  Background diabetic retinopathy.\r\n\r\n          -  Center involving macular edema with CST > 325 m as measured by SD-OCT.\r\n\r\n          -  Predominantly intact (80%) ELM and IS/OS lines within 500 m of the fovea on both\r\n             horizontal and vertical SD-OCT scans.\r\n\r\n          -  Best corrected Snellen visual acuity from 20/40 to 20/280 inclusive","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Men and women, > 18 years of age with type 1 or 2 diabetes mellitus diagnosed and\r\n             treated by an endocrinologist, internist or family medicine physician\r\n\r\n          -  Background diabetic retinopathy\r\n\r\n          -  DME with central subfield thickness (CST) > 325 m by Spectral Domain Optical\r\n             Coherence Tomography (SD-OCT)\r\n\r\n          -  HbA1c level of < 10.0 mg/dl\r\n\r\n          -  Previous cataract surgery with implantation of a stable posterior chamber intraocular\r\n             lens or a phakic eye with 1+ (out of 4+ scale) or less lens opacification\r\n\r\n          -  Predominantly intact (80%) external limiting membrane (ELM) and photoreceptor\r\n             inner/outer segment (IS/OS) lines within 500 m of the fovea on horizontal and\r\n             vertical SD-OCT scans\r\n\r\n          -  Best corrected Snellen visual acuity from 20/40 to 20/280 inclusive.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Intraocular anti-vascular endothelial growth factor (VEGF) injection within the\r\n             previous 3 months\r\n\r\n          -  Systemic anti-VEGF or receptor tyrosine kinase inhibitor therapy within the previous 3\r\n             months\r\n\r\n          -  Intraocular corticosteroid injection within the previous 6 months\r\n\r\n          -  Peri-ocular corticosteroid injection within the previous 3 months\r\n\r\n          -  Vitreomacular traction on SD-OCT scan (epiretinal membrane is allowed)\r\n\r\n          -  Previous anterior or pars plana vitrectomy\r\n\r\n          -  Glaucoma (IOP of > 21 mmHg or regular use of more than 2 IOP lowering drugs)\r\n\r\n          -  Previous trabeculectomy\r\n\r\n          -  Likelihood of needing intraocular surgery within 6 months\r\n\r\n          -  Hard exudates involving the fovea\r\n\r\n          -  Proliferative diabetic retinopathy with any evidence of retinal traction\r\n\r\n          -  Cataract of grade 2+ or greater.\r\n      ","sponsor":"Mayo Clinic","sponsor_type":"Other","conditions":"Diabetes With Diabetic Retinopathy With Macular Edema","interventions":[{"intervention_type":"Procedure","name":"Procedure: Vitrectomy"}],"outcomes":[{"outcome_type":"primary","measure":"average (mean) improvement in Best Corrected Visual Acuity (BCVA) as measured with Snellen visual acuity","time_frame":"6 months"}]}
{"nct_id":"NCT02958592","start_date":"2015-06-30","enrollment":121,"brief_title":"Assessment of Hepatic Fibrosis by Shear Wave Elastography in Patients With Liver Malignancy: A Prospective Single-center Study","official_title":"Assessment of Hepatic Fibrosis by Shear Wave Elastography in Patients With Liver Malignancy: A Prospective Single-center Study","primary_completion_date":"2016-03-31","study_type":"Observational","rec_status":"Completed","completion_date":"2016-10-31","last_update":"2016-11-08","description":"To evaluate the diagnostic performance of two-dimensional shear-wave elastography (SWE) for staging hepatic fibrosis in the background liver parenchyma in patients with liver tumors before hepatic resection, using resected tissue pathology as a reference standard.","other_id":"2016-FXY-132","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":65,"population":"Patients diagnosed with liver tumor intend to hepatectomy","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  (i) patients with a solid focal liver lesion that was pathologically proven or\r\n             diagnosed by imaging methods such as conventional US, CT or MR imaging; (ii) patients\r\n             scheduled to undergo a hepatectomy; (iii) patients with a lesion 1.0 cm in diameter.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  (i) patients with a history of chemotherapy; (ii) patients unable to properly hold\r\n             their breath.\r\n      ","sponsor":"Sun Yat-sen University","sponsor_type":"Other","conditions":"Liver Tumor|Hepatic Fibrosis","interventions":[{"intervention_type":"Other","name":"Other: two-dimensional shear-wave elastography (SWE)","description":"performa two-dimensional shear-wave elastography (SWE) for staging hepatic fibrosis in the background liver parenchyma in patients with liver tumors before hepatic resection"}],"outcomes":[{"outcome_type":"primary","measure":"Stage of hepatic fibrosis","time_frame":"within the first 7 days after surgery","description":"compare the stage of hepatic fibrosis between SWE test with specimens after surgery"}]}
{"nct_id":"NCT02462889","start_date":"2015-06-30","phase":"Phase 2","enrollment":128,"brief_title":"IAI Versus Sham as Prophylaxis Against Conversion to Neovascular AMD","official_title":"A Prospective, Single-Blind, Randomized Study to Evaluate Intravitreal Aflibercept Injection (IAI) Versus Sham as PROphylaxis Against CONversion to Neovascular Age-Related Macular Degeneration (AMD) in High-Risk Eyes","primary_completion_date":"2018-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2018-12-31","last_update":"2016-03-31","description":"This is a prospective, single-blind, randomized study to evaluate intravitreal aflibercept injection (IAI) versus sham as prophylaxis against conversion to neovascular age-related macular degeneration (AMD) in \"high-risk\" subjects.","other_id":"VGFTe-AMD-1507","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Study eye must have a diagnosis of non-exudative age-related degeneration\r\n             characterized by the presence of many intermediate sized drusen, 1 or more large\r\n             drusen, and/or hyperpigmentary changes. Fellow (non-study) eye must have CNV lesion\r\n             (i.e., leakage on fluorescein angiography and/or subretinal, intraretinal, or sub-RPE\r\n             fluid on OCT) secondary to age-related macular degeneration OR history of CNV lesion\r\n             secondary to age-related macular degeneration, as confirmed by current or past\r\n             treatment or current or past diagnostic imaging.\r\n\r\n          -  Subject must be willing and able to comply with clinic visits and study-related\r\n             procedures.\r\n\r\n          -  Subject must provide signed informed consent.\r\n\r\n          -  Subject must be able to understand and complete study-related questionnaires. In order\r\n             to participate in the home monitoring sub-study, subjects must have an approved\r\n             wireless device (i.e. iPhone, iPad, or iPod running iOS 6.0 or later) or be willing to\r\n             use a loaned device and have access to a wireless Internet connection for the duration\r\n             of the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Evidence of neovascular AMD in the study eye at time of enrollment or anytime in the\r\n             past. The reading center must confirm that there is no evidence of neovascular AMD in\r\n             the study eye prior to enrollment.\r\n\r\n          -  Serous PED of any size in the study eye, as determined by the reading center.\r\n\r\n          -  Previous treatment with verteporfin PDT, anti-VEGF therapy, laser, external beam\r\n             radiation or other AMD therapy in the study eye.\r\n\r\n          -  History of macular hole in study eye.\r\n\r\n          -  History of vitrectomy in study eye.\r\n\r\n          -  Lens extraction or implantation within the last 3 months.\r\n\r\n          -  Capsulotomy within the last 1 month.\r\n\r\n          -  Lens or other media opacity that would preclude good fundus photography or angiography\r\n             within the next 2 years.\r\n\r\n          -  Macular edema or signs of diabetic retinopathy more severe than 10 red dots\r\n             (microaneurysms or blot hemorrhages).\r\n\r\n          -  Retinal changes related to high myopia and/or myopic correction greater than 8.00\r\n             diopters spherical equivalent.\r\n\r\n          -  Any progressive ocular disease that would affect visual acuity within the next 2\r\n             years.\r\n\r\n          -  Previous participation in any studies of investigational drugs likely to have ocular\r\n             effects within 30 days preceding the initial study treatment.\r\n\r\n          -  Concurrent use of systemic anti-VEGF agents.\r\n\r\n          -  Active or recent (within 4 weeks) intraocular inflammation (grade trace or above) in\r\n             the study eye.\r\n\r\n          -  Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either\r\n             eye.\r\n\r\n          -  For subjects who have undergone prior refractive or cataract surgery in the study eye,\r\n             the preoperative refractive error in the study eye cannot exceed 8 diopters of myopia.\r\n\r\n          -  Uncontrolled glaucoma in the study eye (defined as intraocular pressure greater than\r\n             25 mmHg) despite treatment with anti-glaucoma medication).\r\n\r\n          -  Subjects who are unable to be photographed to document CNV due to known allergy to\r\n             fluorescein dye, lack of venous access or cataract obscuring the CNV.\r\n\r\n          -  Subjects with other ocular diseases that can compromise the visual acuity of the study\r\n             eye such as amblyopia and anterior ischemic optic neuropathy.\r\n\r\n          -  Current treatment for active systemic infection.\r\n\r\n          -  Evidence of significant uncontrolled concomitant diseases such as cardiovascular\r\n             disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal\r\n             disorders.\r\n\r\n          -  History of recurrent significant infections or bacterial infections.\r\n\r\n          -  Inability to comply with study or follow-up procedures.\r\n\r\n          -  Pregnancy (positive pregnancy test) or lactation\r\n      ","sponsor":"Jeffrey S Heier","sponsor_type":"Other","conditions":"Age-Related Macular Degeneration","interventions":[{"intervention_type":"Drug","name":"Drug: Intravitreal aflibercept injection","description":"Intravitreal aflibercept injection"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Sham injection"}],"outcomes":[{"outcome_type":"primary","measure":"Proportion of subjects converting to neovascular AMD at 24 months, characterized by the development of choroidal neovascularization (CNV).","time_frame":"24 months"},{"outcome_type":"secondary","measure":"Mean change in visual acuity at 24 months compared to baseline","time_frame":"24 months"},{"outcome_type":"secondary","measure":"Percentage of subjects losing less than 15 ETDRS letters at 24 months compared to baseline","time_frame":"24 months"},{"outcome_type":"secondary","measure":"Incidence and severity of potential ocular side effects including endophthamitis, retinal detachment, cataract, and intraocular inflammation","time_frame":"up to Month 24"},{"outcome_type":"secondary","measure":"Incidence and severity of systemic side effects","time_frame":"up to Month 24"}]}
{"nct_id":"NCT02679222","start_date":"2015-06-30","phase":"N/A","enrollment":10,"brief_title":"Comparing the Ketogenic Effect of Coconut Oil and Different MCTs","official_title":"Comparing the Ketogenic Effect of Coconut Oil and Different Medium-chain Triglycerides","primary_completion_date":"2016-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-03-01","last_update":"2020-04-06","description":"The aim of this study is to compare the ketogenic effect of coconut oil and three MCT oils (60-40 , tricaprylin and triheptanoate) on the production of ketones in healthy adults. Each oil are evaluated individually or in combination over a 8h-period during which repeated blood sampling is performed.","other_id":"2016-541","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy adult over 18 y old.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Fasting plasma glucose 7.0 mM (diabetics or pre-diabetics);\r\n\r\n          -  Smoking\r\n\r\n          -  Clinically-significant gastro-intestinal disease/conditions.\r\n\r\n          -  Clinically-significant liver disease/dysfunction.\r\n\r\n          -  Clinically-significant cardiac disease/conditions.\r\n\r\n          -  Clinically-significant abnormal coagulation.\r\n\r\n          -  Taking a medication that could affect lipid and glucose metabolism\r\n\r\n          -  Hypertension\r\n\r\n          -  Pregnancy or breastfeeding\r\n\r\n          -  Exercising more than 3 times a week\r\n      ","sponsor":"Universit de Sherbrooke","sponsor_type":"Other","conditions":"Healthy Adults","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Coconut oil","description":"20 g of coconut oil"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Coconut oil + MCT","description":"10 g of coconut oil + 10 g of MCT (60 of C8 + 40 of C10)"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: MCT","description":"20 g of MCT (60 of C8+40 of C10)"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Coconut oil + tricaprylin","description":"10 g coconut oil + 10 g tricaprylin"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Tricaprylin","description":"20 g tricaprylin"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Tricaprin","description":"20 g tricaprin"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Control","description":"No supplement taken on this visit"}],"outcomes":[{"outcome_type":"primary","measure":"Plasma Ketone Concentrations","time_frame":"8 hours","description":"Total ketones = Plasma acetoacetate (µmol/L) + beta-hydroxybutyrate (µmol/L) measured over a 8 hour period (i.e. daily mean).\r\nSamples are taken every 30 minutes on a 8 hours period. The mean is reported here."},{"outcome_type":"secondary","measure":"Plasma Acetoacetate/Beta-hydroxybutyrate Ratio","time_frame":"8 hours","description":"Plasma ratio of acetoacetate (µmol/L)/ beta-hydroxybutyrate (µmol/L) measured over a 8 hour period (i.e area-under-the-curve over 8 hours)."}]}
{"nct_id":"NCT02430012","start_date":"2015-06-30","phase":"N/A","enrollment":10009,"brief_title":"Quality Measurement and Improvement Study of Surgical Coronary Revascularization: Secondary Prevention","official_title":"Quality Measurement and Improvement Study of Surgical Coronary Revascularization: Secondary Prevention","primary_completion_date":"2016-09-18","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-09-30","last_update":"2019-03-21","description":"The investigators have identified underuse of secondary prevention medications at discharge of patients underwent coronary artery bypass grafting (CABG) in China. The aim of this study is to develop series of quality improvement strategies focusing on secondary prevention medications for patients underwent CABG, and to evaluate their effectiveness and safety via a hospital-level cluster randomized clinical trial. The investigators established a network of 60 hospitals which have participated into Chinese Cardiovascular Surgery Registry and submitted 50 or more CABG surgeries already. The participating sites will be divided into intervention and control groups in a 1:1 ratio. The intervention group will undertake intervention of quality improvement strategies, while the control group will maintain the routine practice pattern. All hospitals will consecutively enroll and submit data of CABG during the enrollment period, estimated for 6 months. The prescribing rates of angiotensin converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), beta-blockers, statins and aspirins will be compared between 2 groups.","other_id":"MOST-2013BAI09B01-2","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"Single","intervention_model_description":"The study was a cluster randomized controlled trial to test the effectiveness of a smartphone-based multifaceted intervention. Sixty hospitals were randomized to the intervention group (n=30) or control group (n=30). Clinicians at intervention hospitals received multifaceted interventions (i.e., centralized training, evidenced-based checklists, and performance monitoring and feedback report) aimed at improving discharge prescription adherence, while those at control hospitals maintained routine practice.","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients underwent CABG during the enrollment period in participating sites\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who die during hospitalization\r\n\r\n          -  Patients who withdrawn from hospital against doctors' recommendations\r\n\r\n          -  Patients who transfer out to other medical care institutions without discharge\r\n             prescription\r\n      ","sponsor":"China National Center for Cardiovascular Diseases","sponsor_type":"Other","conditions":"Coronary Artery Bypass Grafting|Secondary Preventions","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Quality improvement strategies","description":"Training with guidelines of secondary preventions; determining improvement goals; tools (workflow posters and cards, checklists to inform the use of secondary prevention medications); periodical quality feedback report."}],"outcomes":[{"outcome_type":"primary","measure":"statins use at discharge","time_frame":"14 days on average (during hospitalization)","description":"Proportion of statins prescription at discharge among eligible patients"},{"outcome_type":"secondary","measure":"ACEI/ARBs use at discharge","time_frame":"14 days on average (during hospitalization)","description":"Proportion of β-blockers prescription at discharge among eligible patients"},{"outcome_type":"secondary","measure":"β-blockers use at discharge","time_frame":"14 days on average (during hospitalization)","description":"Proportion of β-blockers prescription at discharge among eligible patients"},{"outcome_type":"secondary","measure":"aspirins use at discharge","time_frame":"14 days on average (during hospitalization)","description":"Proportion of aspirins prescription at discharge among eligible patients"},{"outcome_type":"other","measure":"education on smoking cessation at discharge","time_frame":"14 days on average (during hospitalization)","description":"Proportion of education on smoking cessation at discharge among eligible patients"},{"outcome_type":"other","measure":"education on glycemic control at discharge","time_frame":"14 days on average (during hospitalization)","description":"Proportion of education on glycemic control at discharge among eligible patients"},{"outcome_type":"other","measure":"education on moderate exercise at discharge","time_frame":"14 days on average (during hospitalization)","description":"Proportion of education on moderate exercise at discharge among eligible patients"},{"outcome_type":"other","measure":"education on weight control at discharge","time_frame":"14 days on average (during hospitalization)","description":"Proportion of education on weight control at discharge among eligible patients"}]}
{"nct_id":"NCT02320812","start_date":"2015-06-30","phase":"Phase 1/Phase 2","enrollment":28,"brief_title":"Safety of a Single, Intravitreal Injection of Human Retinal Progenitor Cells (jCell) in Retinitis Pigmentosa","official_title":"A Prospective, Multicenter, Open-Label, Single-Arm Study of the Safety and Tolerability of a Single, Intravitreal Injection of Human Retinal Progenitor Cells (jCell) in Adult Subjects With Retinitis Pigmentosa (RP)","primary_completion_date":"2017-07-19","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-07-19","last_update":"2019-03-05","description":"This study evaluates the safety and potential activity of a single dose of live human retinal progenitor cells (jCell) administered to adults with retinitis pigmentosa. Four different dose levels of cells will be assessed in each of two groups of patients.","other_id":"JC-01","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Clinical diagnosis of RP confirmed by electroretinogram (ERG) and willing to consent\r\n             to mutation typing, if not already done\r\n\r\n          -  Best corrected visual acuity (BCVA) 20/63 or worse and no worse than hand motions (HM)\r\n\r\n          -  Adequate organ function and negative infectious disease screen\r\n\r\n          -  Female of childbearing potential must have negative pregnancy test and be willing to\r\n             use medically accepted methods of contraception throughout the study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Eye disease other than RP that impairs visual function\r\n\r\n          -  Pseudo-RP, cancer-associated retinopathies\r\n\r\n          -  History of malignancy or other end-stage organ disease, or any chronic disease\r\n             requiring continuous treatment with system steroids, anticoagulants or\r\n             immunosuppressive agents\r\n\r\n          -  Known allergy to penicillin or streptomycin\r\n      ","sponsor":"jCyte, Inc","sponsor_type":"Industry","conditions":"Retinitis Pigmentosa (RP)","interventions":[{"intervention_type":"Biological","name":"Biological: human retinal progenitor cells","description":"single intravitreal injection of 0.5 - 3.0 million human retinal progenitor cells (hRPC)"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Subjects With Adverse Events as a Measure of Safety and Tolerability","time_frame":"12 months","description":"proportion of subjects with treatment emergent adverse events (TEAE), related TEAE and severe TEAE"},{"outcome_type":"secondary","measure":"Change in Mean Best Corrected Visual Acuity (BCVA)","time_frame":"12 months","description":"change in mean best corrected visual acuity in test eye versus untreated eye; BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. Change between baseline and month 12 is reported."}]}
{"nct_id":"NCT02704117","start_date":"2015-06-30","phase":"Phase 3","enrollment":30,"brief_title":"Neurocircuitry of Obsessive-Compulsive Disorder: Modulation by Transcranial Magnetic Stimulation","official_title":"Neurocircuitry of OCD: Effects Of Modulation","primary_completion_date":"2021-10-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-10-31","last_update":"2020-08-13","description":"The purpose of this study is to test the effects of non-invasive neuromodulation, transcranial magnetic stimulation on brain function in individuals with obsessive-compulsive disorder (OCD). This study is focused on the mechanism(s) by which brain stimulation might change the functioning of regions implicated in OCD, and thereby inform possible future therapeutic uses.","other_id":"P50MH106435","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Current primary OCD diagnosis and current Y-BOCS total score of 16\r\n\r\n          -  18-70 years of age\r\n\r\n          -  Ability to speak, read, write, and understand English sufficiently well to complete\r\n             study procedures and provide informed consent\r\n\r\n          -  No use of psychiatric medications or stable psychiatric medication use for a minimum\r\n             of 6 week prior to study entry\r\n\r\n          -  Ongoing psychotherapy allowed if already established for three months or more before\r\n             study entry\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of primary psychotic disorder or bipolar disorder\r\n\r\n          -  Present acute suicidality\r\n\r\n          -  History of head injury, epilepsy, or other clinically significant neurological illness\r\n             except tic disorders\r\n\r\n          -  Active systemic medical (metabolic, endocrine, chronic inflammatory, vascular,\r\n             autoimmune) disease\r\n\r\n          -  Premorbid intelligence quotient (IQ) estimate < 80\r\n\r\n          -  Visual disturbance (<20/40 Snellen visual acuity, corrected)\r\n\r\n          -  Current, or alcohol or illicit substance abuse/dependence in the last 3 months\r\n\r\n          -  Contraindications to TMS or MRI: metallic foreign objects, e.g., aneurysm\r\n             clips/pacemakers, or questionable history of metal fragments, claustrophobia\r\n\r\n          -  Women who are pregnant or breastfeeding. All women participants of reproductive age\r\n             are required to have a negative pregnancy test prior to enrollment and use medically\r\n             acceptable birth control throughout the study (barrier and/or oral contraceptives)\r\n\r\n          -  Current psychotic symptoms\r\n\r\n          -  An increased risk of seizure, determined by history\r\n\r\n          -  Medications judged to notably affect cortical excitability e.g., anticonvulsants or\r\n             high-dose benzodiazepines (> 4 mg/day of clonazepam or equivalent)\r\n\r\n          -  Predominant hoarding symptoms\r\n      ","sponsor":"Butler Hospital","sponsor_type":"Other","conditions":"Obsessive-Compulsive Disorder","interventions":[{"intervention_type":"Device","name":"Device: Transcranial Magentic Stimulation","description":"This is a form of mild brain stimulation delivered noninvasively. The device delivers pulses of magnetic energy through a coil placed on the scalp. The treatment takes 41 seconds, and takes place for ten sessions, Monday through Friday, over the course of two weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Change in activation of pre-supplementary motor area/dorsal anterior cingulate cortex (pSMA/dACC) on functional magnetic resonance imaging (fMRI) during the Multi-Source Interference task (MSIT)","time_frame":"Baseline and 6 months"},{"outcome_type":"secondary","measure":"Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS)","time_frame":"Baseline and 6 months"}]}
{"nct_id":"NCT02215421","start_date":"2015-06-30","phase":"N/A","enrollment":0,"brief_title":"Mommio: Training in Vegetable Parenting","official_title":"Kiddio Food Fight: Training Parents in Effective Vegetable Parenting","primary_completion_date":"2016-02-29","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2016-02-29","last_update":"2016-10-14","description":"A 20 episode video game called Mommio simulates parent-child feeding interactions for parents of 3-5 year old children within a storyline addressing a problem commonly reported by parents (getting their 3-5 yo to taste a vegetable, which is often a first step toward eating the vegetable), thereby training parents in effective food parenting practices. This research evaluates whether the 20 episodes targeting barriers identified by parents across five levels of difficulty influences vegetable parenting practices and children's dietary intake. We had to discontinue the study since changes in commercial availability of game development software required reprogramming and available funding did not allow for completion of game programming. Thus, no game evaluation was possible.","other_id":"H-33915","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  being a parent of a child 3-5 years old\r\n\r\n          -  willing to complete all measures\r\n\r\n          -  having an iPhone.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  the parent not speaking English (since the games are in English alone, due to budget\r\n             constraints);\r\n\r\n          -  having a 3-5 year old child with a medical condition that influences diet; or\r\n\r\n          -  a parent with an illness that impairs the ability to complete questionnaires\r\n      ","sponsor":"Archimage, Inc.","sponsor_type":"Industry","conditions":"Obesity","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Mommio","description":"The objective is to build parent's skills in encouraging their child to eat vegetables. The player is asked to read a novella, \"Totally Frobisher\" (providing backstory to the game), and play a game called Mommio (a \"casual\" video game for parents of 3 to 5 year old children). The player calls Kiddio, the child character, to dinner, and offers a vegetable (V) (selected from among several). Kiddio refuses. The player is offered a selection of V parenting statements (from the scientific literature on food parenting) or manipulation of the environment (e.g. turning off the kitchen TV) to control the situation and encourage the child to eat the V. As problems arise (e.g. a permissive father saying he doesn't like vegetables), the player must select ways to cope. Players set a goal to do with their child at home what they learned in the game. Game episodes include food store shopping, eating in the car, at grandma's, and at a fast food store."}],"outcomes":[{"outcome_type":"primary","measure":"Change in Parent Reported Child Vegetable FFQ","time_frame":"One month from pre to post","description":"To assess the preschool child's usual vegetable (V) intake, the participating parent will complete the V items from a 36 item FV screener which was demonstrated to have acceptable correlations with serum lycopene, lutein, cryptoxanthin, alphacarotene, and beta-carotene with a validity coefficient (r=0.35 with total carotenoids) comparable to the sum of three 24-hour dietary recalls. Parents have been shown to reliably and validly report preschool child diet intake. The response scales will be worded to reflect child's intake in the previous week. Item responses will be summed to estimate number of V servings consumed in the previous week. This questionnaire has been validated for parent report on children, and was sensitive to change."},{"outcome_type":"secondary","measure":"Change in Vegetable Parenting Practices Questionnaire","time_frame":"One month from pre to post","description":"Fruit and Vegetable Parenting Practices Questionnaire (FVPPQ), a parent-report questionnaire, includes 33 items associated with the effectiveness of parenting practices to get children to eat FV. Items will be scored on a three-point scale to indicate frequency of use of V parenting practices (1 - \"frequently\", 2 - \"sometime\", 3 - \"rarely-never\"). Internal consistency has been demonstrated. Helping HAND induced changes in these parenting practices."},{"outcome_type":"other","measure":"Qualitative Interviews","time_frame":"One month at post only","description":"The intensive interviews will be conducted using a standardized script and commonly accepted procedures (e.g., 8-10 open ended questions, with follow up questions, prompts, and areas to probe). The questions will assess whether they attempted changes in their vegetable parenting practices with their 3-5 year old child, problems they encountered, what parents liked and disliked about the game, and how it could be made better. The parents' interviews will be about 30 minutes and audio tape recorded. Audio tapes will be transcribed verbatim and checked for accuracy prior to analysis. Following generally accepted qualitative data coding and analysis procedures, NVIVO, a qualitative software analysis program, will be utilized to facilitate data coding, retrieval, and analysis."}]}
{"nct_id":"NCT02438917","start_date":"2015-06-30","enrollment":10,"brief_title":"Biomarkers of Liver Fibrosis","official_title":"Biomarkers of Liver Fibrosis","primary_completion_date":"2017-03-03","study_type":"Observational","rec_status":"Terminated","completion_date":"2017-03-03","last_update":"2017-04-12","description":"Chronic liver injury leads to the accumulation of proteins in the liver that form dense scars. Liver scar formation is typically a slow process that leads to major organ damage and loss of function over the course of many years. During scar formation the extracellular matrix in the liver changes. The type and quantity of extracellular collagen and other proteins change during tissue remodeling. Some of these changes can be detected by analyzing factors present in blood. Because of the lengthy time course, changes in the rate of liver scar formation and regression are very difficult measure; however, accurate measurements are needed in order to conduct trials of interventions aimed at preventing scar formation and/or promotion scar regression. Current methods have sub-optimal specificity and selectivity. The long term objective of the study is to identify serum proteins that can be used to accurately estimate rates of liver fibrosis progression and regression. The project focusses on a novel methodology that uses stable isotope labeling with deuterated water, D2O, to tag newly-synthesized proteins. Mass spectroscopy is used to identify individual proteins and to quantify the ratio of labeled protein to total protein. This ratio provides information about the rate of synthesis of the protein of interest. This method will be applied to specimens from patients with hepatitis C virus (HCV) infection who are about to begin HCV treatment. Treatment is known to reduce liver inflammation and collagen content.","other_id":"GCO 15-0548","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients with the hepatitis C virus (HCV) who are about to begin HCV treatment.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adult (18 years of age or older)\r\n\r\n          -  Positive test for HCV RNA\r\n\r\n          -  Planning to initiate treatment for HCV in the near future\r\n\r\n          -  Not diagnosed with any additional liver diseases, such as autoimmune hepatitis,\r\n             hepatitis B, alcoholic liver disease, or HIV\r\n\r\n          -  Able to travel to Mount Sinai\r\n\r\n          -  Must understand and speak English\r\n\r\n          -  Willing to sign informed consent and participate\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnancy\r\n\r\n          -  Incarcerated Person\r\n      ","sponsor":"Icahn School of Medicine at Mount Sinai","sponsor_type":"Other","conditions":"Hepatitis C","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Change in serum protein","time_frame":"baseline and 36 months","description":"Change in the ratio of transforming growth factor binding protein 1 (TGFB1) at 36 months as compared to baseline"},{"outcome_type":"secondary","measure":"Change in the FibroScan score","time_frame":"baseline and 36 months","description":"Change in FibroScan score at 36 months as compared to baseline. FibroScan is performed to assess liver stiffness, an indicator of liver fibrosis."},{"outcome_type":"secondary","measure":"Change in the ELF score","time_frame":"baseline and 36 months","description":"Change in ELF score at 36 months as compared to baseline"},{"outcome_type":"secondary","measure":"Change in the FIB-4 score","time_frame":"baseline and 36 months","description":"Change in the FIB-4 score at 36 months as compared to baseline"}]}
{"nct_id":"NCT03270813","start_date":"2015-06-30","phase":"N/A","enrollment":40,"brief_title":"RAGE-Control: Teaching Emotional Self-regulation Through Videogame Play","official_title":"RAGE-Control: Teaching Emotional Self-regulation Through Videogame Play","primary_completion_date":"2017-03-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2020-12-31","last_update":"2020-07-07","description":"The purpose of this study is to evaluate the use of Regulate and Gain Emotional Control (RAGE-Control), a biofeedback video game, in combination with brief instruction in relaxation skills as an intervention for symptoms of anger and aggression in children and adolescents. Half of the research participants will learn relaxation techniques and practice them using the RAGE-Control videogame. The other half of the participants will learn relaxation techniques and play a similar videogame without the biofeedback component. The investigators hypothesize that participants in the RAGE-Control group will show a greater reduction in symptoms of anger and aggression than those in the non-RAGE-Control group.","other_id":"2015P000901","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":7,"maximum_age":17,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Problems with anger and/or aggression\r\n\r\n          -  Score of at least 4/10 on phone screen with parents measuring anger and aggression\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Changes in dosing of psychotropic medications within the 8 weeks prior to the start of\r\n             the study, or anticipated medication changes during the study.\r\n\r\n          -  Starting therapy within the 8 weeks prior to starting the study, or anticipated new\r\n             therapy beginning during the study.\r\n\r\n          -  Actively participating in any type of Cognitive Behavioral Therapy for less than 12\r\n             weeks and/or attending Cognitive Behavioral Therapy weekly or more.\r\n\r\n          -  Intellectual disability (IQ < 80)\r\n\r\n          -  Suicidal ideation\r\n\r\n          -  Homicidal ideation\r\n\r\n          -  Psychosis/meets criteria for psychotic disorder\r\n      ","sponsor":"Massachusetts General Hospital","sponsor_type":"Other","conditions":"Anger|Aggression","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Relaxation training plus RAGE-Control","description":"RAGE-Control is a biofeedback videogame in which players shoot at enemies while avoiding allies. The player's baseline heart rate is taken before the game and entered into the computer. During the game, the player wears a heart rate monitor, and if the player's heart rate rises above baseline, they are unable to shoot. The player must use relaxation skills to decrease their heart rate below the baseline before they can resume play. Participants will undergo relaxation training during each of 6 sessions, and then practice the skills they learned while playing the RAGE-Control videogame."},{"intervention_type":"Behavioral","name":"Behavioral: Relaxation training plus Sham Videogame","description":"The Sham videogame is a videogame in which players shoot at enemies while avoiding allies. The player wears a heart rate monitor during the game, but the heart rate does not affect the functioning of the game in any way. Participants will undergo relaxation training during each of 6 sessions, and then practice the skills they learned while playing the Sham videogame."}],"outcomes":[{"outcome_type":"primary","measure":"Clinical Global Impressions Global Rating of Improvement (CGI-I)","time_frame":"Up to 3 months post-intervention","description":"Assesses improvement post treatment, with scores ranging from 1 (very much improved) to 7 (very much worse)."},{"outcome_type":"secondary","measure":"Clinical Global Impressions Severity of Illness (CGI-S)","time_frame":"Up to 3 months post intervention","description":"Assess overall burden of illness on a scale from 1 (normal, not ill) to 7 (very severely ill)."},{"outcome_type":"secondary","measure":"State Trait Anger Expression Inventory for Children and Adolescents (STAXI-CA)","time_frame":"Baseline, 2 weeks post treatment, 3 months post treatment","description":"35 item self-report scale that assesses state anger, trait anger and expression of anger."},{"outcome_type":"secondary","measure":"Multidimensional Adolescent Satisfaction Scale (MASS)","time_frame":"2 weeks post treatment, 3 months post treatment","description":"Measures patient satisfaction with the intervention"},{"outcome_type":"secondary","measure":"Modified Overt Aggression Scale (MOAS)","time_frame":"Baseline, 2 weeks post treatment, 3 months post treatment","description":"Records the severity of 4 types of aggression: verbal, against property, physical, and against self."},{"outcome_type":"secondary","measure":"Difficulties in Emotion Regulation Scale (DERS)","time_frame":"Baseline, 2 weeks post treatment, 3 months post treatment","description":"36-item, self-report questionnaire designed to assess multiple aspects of emotion dysregulation. For patients age 10 and older only."},{"outcome_type":"secondary","measure":"Difficulties in Emotion Regulation Scale - impulse control difficulties","time_frame":"Up to 3 months post intervention","description":"6 items of the DERS specifically designed to assess impulse control difficulties. For patients age 10 and older only."},{"outcome_type":"secondary","measure":"Child Behavior Checklist (CBCL) 6-18","time_frame":"Baseline, 2 weeks post treatment, 3 months post treatment","description":"Empirically based checklist of social competence and behavioral problems, filled out by parents based on recent behavior."},{"outcome_type":"secondary","measure":"Heart rate","time_frame":"Weekly for 6 weeks","description":"The computer will record each participant's heart rate while they play the videogame."},{"outcome_type":"secondary","measure":"Emotion Regulation Checklist (ERC)","time_frame":"Up to 3 months post intervention","description":"24 item parent-report questionnaire regarding a child's ability to assess emotion regulation in the past 1 week."}]}
{"nct_id":"NCT02513745","start_date":"2015-06-30","phase":"N/A","enrollment":84,"brief_title":"Conventional Surgery vs. Verion/VerifEye","official_title":"Refractive Outcomes Evaluation of the Verion Image Guided System + ORA System With VerifEye","primary_completion_date":"2017-05-05","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-05-05","last_update":"2019-09-04","description":"Nowadays cataract patient's expectations are closer to those of refractive surgery patients. Patients want to be spectacle independent. However, fifteen to twenty percent of cataract surgery patients have from 1.00 to 3.00 diopters (D) of corneal astigmatism which makes achieving spectacle independence unlikely in this patients unless the astigmatism is treated at the time of cataract surgery. Option to treat this astigmatism include corneal or limbal incisions (LRIs), the use of toric intraocular lenses (IOLs) or LASIK. Regardless of the treatment of choice to correct the astigmatism at time of cataract extraction, a treatment plan has to be calculated preoperatively. This planning include: keratometry measurements and the use of a calculator to estimate the treatment and orientation of IOL and/or placement of the LRIs. New technology has been developed and is widely used. Among this technology, we have the VERION Image Guided System. This system encompasses a reference unit that takes a picture of the eye with the patient in the sitting position creating image of the patient's eye, capturing scleral vessels, limbus and iris features. It measures keratometry as well as the corneal diameter (limbus) and pupil size. The information captured is transferred automatically to its planner where IOL power calculation and astigmatism correction calculation are completed. Additionally, intraoperative wavefront aberrometry has been used in the last couple of years with increase success.","other_id":"CEP 2014-003","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subject is undergoing bilateral cataract extraction or refractive lens exchange with\r\n             intraocular lens implantation and astigmatism correction.\r\n\r\n          -  Willing and able to provide written informed consent for participation in the study\r\n\r\n          -  Willing and able to comply with scheduled visits and other study procedures.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative\r\n             diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment,\r\n             aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization,\r\n             medically uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerve\r\n             atrophy, macular degeneration (with anticipated best postoperative visual acuity less\r\n             than 20/30), advanced glaucomatous damage, etc.\r\n\r\n          -  Uncontrolled diabetes.\r\n\r\n          -  Use of any systemic or topical drug known to interfere with visual performance.\r\n\r\n          -  Contact lens use during the active treatment portion of the trial.\r\n\r\n          -  Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis.\r\n\r\n          -  Pseudoexfoliation syndrome or any other condition that has the potential to weaken the\r\n             zonules\r\n\r\n          -  Previous refractive surgery.\r\n\r\n          -  Any clinically significant, serious or severe medical or psychiatric condition that\r\n             may increase the risk associated with study participation or study device implantation\r\n             or may interfere with the interpretation of study results.\r\n\r\n          -  Participation in (or current participation) any investigational drug or device trial\r\n             within the previous 30 days prior to the start date of this trial.\r\n\r\n          -  Intraocular conventional surgery within the past three months or intraocular laser\r\n             surgery within one month in the operated eye.\r\n      ","sponsor":"Carolina Eyecare Physicians, LLC","sponsor_type":"Other","conditions":"Cataract|Astigmatism","interventions":[{"intervention_type":"Device","name":"Device: Conventional","description":"Routine cataract surgery by phacoemulsification before laser-assisted cataract surgery."},{"intervention_type":"Device","name":"Device: Refractive Cataract Suite (Verion + ORA)","description":"Laser-assisted cataract surgery with the digital surgical planning and positioning tools, and intraoperative aberrometry."}],"outcomes":[{"outcome_type":"primary","measure":"Residual Refractive Cylinder","time_frame":"Three months","description":"This is the manifest refractive cylinder measured 3 months after surgery. Note that because cataract surgery has been performed, there is no associated baseline value."},{"outcome_type":"secondary","measure":"Residual Mean Spherical Equivalent Refraction","time_frame":"Three months","description":"This is the mean of the spherical equivalent refraction (sphere + 0.5*cylinder) from each eye. Note that because cataract surgery has been performed, there is no associated baseline value."},{"outcome_type":"secondary","measure":"Residual Corneal Astigmatism","time_frame":"Three months","description":"This is the anterior corneal astigmatism measured through keratometry. Note that because cataract surgery has been performed, there is no associated baseline value."}]}
{"nct_id":"NCT01890200","start_date":"2015-06-30","phase":"Phase 3","enrollment":0,"brief_title":"The Effects of Adding TCM-700C on the Standard Combination Treatment for HCV Genotype 1 Patients(Phase III)","official_title":"A Phase III, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Effects of Adding TCM-700C,Botanical Drug, on the Standard Treatment (Peginterferon and Ribavirin) for Subjects With Naive Genotype 1 Hepatitis C Infection","primary_completion_date":"2018-03-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2018-06-30","last_update":"2017-04-28","description":"This is a randomized, double blind, multi-center, placebo controlled, three parallel arms, Phase IIb/III clinical study to evaluate the effects of adding a TCM-700C with a low or high dose onto the combination treatment (PegIFN plus RBV) for subjects with naive genotype 1 HCV infection. This will be demonstrated by a higher sustained virologic response rate, defined as the absence of detectable HCV RNA 24 weeks after the termination of combination treatment, compared with the placebo add-on.","other_id":"TCM-700-02-01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adult subjects who are 20 to 65 years old (inclusive), of either gender and in any\r\n             ethnical group in Asia.\r\n\r\n          -  Chronic hepatitis C, positive with both antibody to hepatitis C virus (anti HCV) and\r\n             HCV RNA assays.\r\n\r\n          -  Confirmed HCV genotype 1.\r\n\r\n          -  Subjects who are indicated to have combination treatment of PegIFN 2a and RBV at the\r\n             discretion of the investigator.\r\n\r\n          -  All fertile males and females receiving RBV must be using two forms of effective\r\n             contraception during treatment with study drugs and 6 months post treatment\r\n             completion.\r\n\r\n          -  Subjects must voluntarily give written informed consent indicating that they\r\n             understand the purpose of and procedures required for the study and are willing to\r\n             participate in the study.\r\n\r\n          -  Subjects must be able to comply with the assessments during the study.\r\n\r\n          -  Subjects must be able to understand study QoL questionnaires.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior treatment with any IFN  or any medicines that contain Cordyceps.\r\n\r\n          -  Prior treatment of hepatitis C with any other antiviral or immune modulators.\r\n\r\n          -  Investigational therapy administered within 4 weeks, or within a time interval less\r\n             than at least 5 half lives of the investigational agent, whichever is longer, prior to\r\n             the first scheduled day of dosing in this study.\r\n\r\n          -  Subjects diagnosed with hepatocellular carcinoma (HCC) by biopsy or  fetoprotein\r\n             (AFP) serology and radiology (helical computed tomography [CT] and/or magnetic\r\n             resonance imaging [MRI]) within 5 years of signing the informed consent form.\r\n\r\n          -  Evidence of hepatic decompensation (history or current evidence of ascites, bleeding\r\n             varices or hepatic encephalopathy).\r\n\r\n          -  History or evidence of other liver diseases other than chronic HCV infection.\r\n\r\n          -  Subjects with known allergy or hypersensitivity to any ingredient of the study drug or\r\n             placebo.\r\n\r\n          -  Pregnant, planning on becoming pregnant, or breastfeeding female subject or male\r\n             subject whose partner is pregnant or planning on becoming pregnant.\r\n\r\n          -  Subject with any of the following laboratory abnormalities:\r\n\r\n               1. Platelet count <90,000/mm3;\r\n\r\n               2. Absolute neutrophil count <1500 cells/mm3;\r\n\r\n               3. Hemoglobin <12 g/dL for women and <13 g/dL for men;\r\n\r\n               4. Creatinine >1.5 mg/dL;\r\n\r\n               5. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >10 x\r\n                  upper limit of normal (ULN);\r\n\r\n               6. Total serum bilirubin >1.5 x ULN;\r\n\r\n               7. Subjects without cirrhosis and AFP >50 ng/mL must have an ultrasound between the\r\n                  screening and baseline visit with no findings suspicious for HCC.\r\n\r\n          -  Medical conditions which are contraindications for PegIFN 2a or RBV therapy:\r\n\r\n               1. Psychiatric disorders;\r\n\r\n               2. Organ transplant (other than cornea or hair transplant or skin graft);\r\n\r\n               3. Severe concurrent medical disease such as severe hypertension, significant\r\n                  coronary heart disease, poorly controlled diabetes mellitus (glycated hemoglobin\r\n                  A1c [HbA1c] >8.5%), not adequately controlled thyroid dysfunction, chronic\r\n                  obstructive pulmonary disease, severe infections (bacterial, viral, fungal,\r\n                  including acute tuberculosis), or hemoglobinopathies (thalassemia major or sickle\r\n                  cell anemia);\r\n\r\n               4. Autoimmune hepatitis or other autoimmune conditions known to be exacerbated by\r\n                  PegIFN 2a and RBV.\r\n\r\n          -  History of a severe seizure disorder or current anticonvulsant use.\r\n\r\n          -  Evidence of severe retinopathy (e.g., cytomegalovirus retinitis, macular degeneration)\r\n             or clinically relevant ophthalmological disorder (e.g., due to diabetes mellitus or\r\n             hypertension).\r\n\r\n          -  Other cases judged by the investigator to be ineligible for participation in the\r\n             study.\r\n      ","sponsor":"TCM Biotech International Corp.","sponsor_type":"Industry","conditions":"Chronic Hepatitis C","interventions":[{"intervention_type":"Drug","name":"Drug: Peginterferon alfa-2a","description":"conventional treatment of Hepatitis C"},{"intervention_type":"Drug","name":"Drug: Ribavirin","description":"conventional treatment of Hepatitis C"},{"intervention_type":"Drug","name":"Drug: TCM-700C","description":"An add-on drug to conventional treatment of Hepatitis C"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo, without acting ingredient."}],"outcomes":[{"outcome_type":"primary","measure":"sustained virologic response (SVR) rate","time_frame":"24 weeks after the end of treatment (EOT, 48 weeks)","description":"undetectable HCV RNA 24 weeks after the EOT."},{"outcome_type":"secondary","measure":"Virologic response (VR)","time_frame":"at the EOT (48 weeks)","description":"undetectable HCV RNA at the EOT."},{"outcome_type":"secondary","measure":"relapse rate","time_frame":"24 weeks after the EOT","description":"undetectable HCV RNA at the EOT followed by a positive HCV RNA level within 24 weeks after the EOT"}]}
{"nct_id":"NCT02461095","start_date":"2015-06-30","phase":"N/A","enrollment":55,"brief_title":"Evaluation of a Treatment Algorithm for Patients With Patellofemoral Pain Syndrome","official_title":"Evaluation of a Treatment Algorithm for Patients With Patellofemoral Pain Syndrome: A Randomized Controlled Trial","primary_completion_date":"2017-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-10-31","last_update":"2018-01-24","description":"Patients with PFPS demonstrate quadriceps and hip musculature weakness, altered lower extremity (LE) kinematics, and decreased LE flexibility. Psychosocial factors have also been identified as an important factor in patients with PFPS. The authors hypothesize that an ordered approach addressing each of these impairments sequentially will result in greater improvement in PFPS symptoms. The results of the investigators pilot study assessing the feasibility of using a sequential approach showed a full randomized controlled trial is warranted, the authors now plan to proceed with a full trial. The objective of this study is to assess the efficacy of a sequential approach in the treatment of Patellofemoral Pain Syndrome. Methods: Patients will be randomized to a sequential treatment approach using a PFPS treatment algorithm (PFPS Algorithm) designed by the authors or typical physical therapy care. Due to the constant evaluation necessary no blinding will be performed. Patients will attend therapy two times per week for six weeks. Pain, Anterior Knee Pain Scale (AKPS), and Global Rating of Change (GROC) will be measured at evaluation and discharge, 3 month follow-up and 6 month follow-up.","other_id":"IRB15-00311","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":12,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        -Clinical Diagnosis of Patellofemoral Pain Syndrome\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Tenderness to palpation of patellar tendon, inferior pole of patella, or tibial\r\n             tubercle as primary complaint\r\n\r\n          -  Patient is pregnant or nursing\r\n\r\n          -  Patient has other current lower extremity injuries\r\n\r\n          -  History of patellar subluxation or dislocations\r\n\r\n          -  History of knee surgery\r\n\r\n          -  Inability to follow directions\r\n      ","sponsor":"Nationwide Children's Hospital","sponsor_type":"Other","conditions":"Patellofemoral Pain Syndrome","interventions":[{"intervention_type":"Other","name":"Other: Impairment based approach","description":"This intervention will consist of exercise, mechanics training, education, manual therapy and modalities. The treatment will address the impairments found during the evaluation. This approach is a typical individualized physical therapy treatment approach."},{"intervention_type":"Other","name":"Other: PFPS Algorithm approach","description":"Physical Therapy treatment for Patellofemoral Pain Syndrome based upon a treatment algorithm that addresses patients: fear avoidance beliefs, flexibility, body mechanics, and strength. The exercises and treatments are individualized to each patient with the goals of low fear avoidance beliefs, flexibility, body mechanics, and strength and are performed in a sequential manner"}],"outcomes":[{"outcome_type":"primary","measure":"Change in Anterior Knee Pain Scale","time_frame":"Baseline, 3 weeks (18-24 days post-evaluation), 6 weeks (39-46 days post-evaluation), 3 months and 6 months","description":"Assessment of change of the Anterior Knee Pain Scale (AKPS). The AKPS is a self-reported 13 item questionnaire with discrete categories related to various levels of current knee function. Categories within each item are weighted, and responses are summed to provide an overall score of 0-100, with 100 representing no disability. The Anterior Knee Pain Scale is found to be valid and reliable in patients from 12-50 years of age presenting with anterior knee pain with a test-retest reliability of .95 (Watson, 2005). A change of 10 points represent the minimal clinical difference (Crossley, 2004)."},{"outcome_type":"secondary","measure":"Change in Numeric Pain Rating Scale","time_frame":"Baseline, 3 weeks (18-24 days post-evaluation), 6 weeks (39-46 days post-evaluation), 3 months and 6 months","description":"The Numeric Pain rating scale asks the patient their highest pain in the last 24 hours. The Numeric Pain Rating Scale is a 0-10 scale subjectively assessing a patients perceived level of pain. With 0 on the scale = to no pain, and 10 = to the worst pain imaginable. The use of the Numerical Pain Rating Scale for assessing pain has been validated for use in PFPS patients and has been found to have a minimal detectable change of 1 points (Piva, 2009). The highest pain value is being used because of a floor effect was noted using average pain during the pilot study."},{"outcome_type":"secondary","measure":"Global Rating of Change Scale (GROC)","time_frame":"Baseline, 3 weeks (18-24 days post-evaluation), 6 weeks (39-46 days post-evaluation), 3 months and 6 months","description":"The Global Rating of Change scale is a 15-point Likert type scale (-7 to +7). A score of 0 represents no change from initial injury, +7 represents a great deal better, and -7 represents a great deal worse. A score of +/- 3 represents a minimal clinical difference (Wang, 2011)."}]}
{"nct_id":"NCT02504177","start_date":"2015-06-30","phase":"N/A","enrollment":433,"brief_title":"Clinical Trial for Optimal Novel Oral Anticoagulant (NOAC) Schedule Immediate Before Catheter Ablation for Atrial Fibrillation","primary_completion_date":"2019-06-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-06-30","last_update":"2019-02-15","description":"This study is to evaluated the interruption schedule of NOAC in patients who undergo atrial fibrillation ablation. The investigators will compare the bleeding complications were classified as major and minor bleeding, thromboembolic, vascular complications, Re-admission and increased in the length of hospital stay during the 30-day post-radiofrequency catheter ablation(RFCA) period among patients who interrupt NOAc 24hours before ablation and patients who stop NOAC in the morning of the procedure.","other_id":"4-2015-0387","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":19,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patients who consent with study\r\n\r\n          2. Patients with Atrial fibrillation (20-80 years old)\r\n\r\n          3. patients who undergoing catheter ablation of atrial fibrillation due to symptomatic,\r\n             drug refractory atrial fibrillation\r\n\r\n          4. Patients possible to NOAC\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients who do not agree with study inclusion\r\n\r\n          2. eGRF < 30ml/min\r\n\r\n          3. Impossible to NOAC\r\n\r\n          4. Structural cardiac disease\r\n\r\n          5. Major hemorrhagic complication\r\n\r\n          6. CHA2DS2-VASc score > 5\r\n\r\n          7. Patients who have experienced Ischemic cerebellar infarction more than 2times\r\n      ","sponsor":"Yonsei University","sponsor_type":"Other","conditions":"Atrial Fibrillation","interventions":[{"intervention_type":"Drug","name":"Drug: novel oral anticoagulant for 30 days","description":"novel oral anticoagulant includes 'dabigatran,Pradaxa', 'rivaroxaban,Xarelto', and 'apixaban, Eliquis'."},{"intervention_type":"Drug","name":"Drug: novel oral anticoagulant for 24 hour","description":"novel oral anticoagulant includes 'dabigatran,Pradaxa', 'rivaroxaban,Xarelto', and 'apixaban, Eliquis'."}],"outcomes":[{"outcome_type":"secondary","measure":"incidence of minor bleeding","time_frame":"during 30 days post-AF ablation."},{"outcome_type":"secondary","measure":"Re-admission rate related procedure","time_frame":"during 30 days post-AF ablation."},{"outcome_type":"secondary","measure":"length of hospital stay","time_frame":"during 30 days post-AF ablation."},{"outcome_type":"secondary","measure":"incidence of vascular complications","time_frame":"during 30 days post-AF ablation.","description":"vascular complication is diagnosed by both clinical situations and image studies combined."},{"outcome_type":"primary","measure":"incidence of major bleeding complications","time_frame":"during 30 days post-AF ablation.","description":"Bleeding complication is assessed by physical examination or laboratory measurement"},{"outcome_type":"secondary","measure":"incidence of thromboembolism","time_frame":"during 30 days post-AF ablation.","description":"thromboembolism is diagnosed by both clinical situations and image studies combined."}]}
{"nct_id":"NCT02455531","start_date":"2015-06-30","enrollment":264,"brief_title":"Long-term Outcomes of Children With Hypoplastic Left Heart Syndrome and the Impact of Norwood Shunt Type","official_title":"Long-term Outcomes of Children With HLHS (Hypoplastic Left Heart Syndrome) and the Impact of Norwood Shunt Type (A Study Conducted by the Pediatric Heart Network)","primary_completion_date":"2020-10-31","study_type":"Observational","rec_status":"Active, not recruiting","completion_date":"2025-06-30","last_update":"2020-10-19","description":"The purpose of this study is to compare direct and indirect measures of right ventricular (RV) systolic and diastolic function between 11 year old subjects who had been randomly assigned to receive a right ventricle to pulmonary artery shunt (RVPAS) vs. a modified Blalock-Taussig shunt (MBTS) at the time of the Norwood operation.","other_id":"U10HL068270-4b","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":10,"maximum_age":12,"population":"All SVR study cohort members will be contacted to assess for vital status. Transplant free\r\n        survivors will be approached to participate in the in-person assessment.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  All SVR study cohort members will be contacted to assess for vital status. Transplant\r\n             free survivors will be approached to participate in the in-person assessment.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who have undergone cardiac transplantation or biventricular conversion from\r\n             all outcomes other than vital status.\r\n\r\n          -  Those with pacemakers will be excluded from the CMR, and patients <130 cm in height\r\n             will be excluded from the exercise test.\r\n      ","sponsor":"HealthCore-NERI","sponsor_type":"Other","conditions":"Heart Defects","interventions":{},"outcomes":[{"outcome_type":"secondary","measure":"The incidence of arrhythmias between those randomized to a RVPAS vs. a MBTS.","time_frame":"11 years ± 1 year to 16 years"},{"outcome_type":"primary","measure":"RV ejection fraction (RVEF) at 11 years, as measured by cardiac magnetic resonance (CMR).","time_frame":"10 to 12 years of age for each participant (11 years ± 1 year)"},{"outcome_type":"secondary","measure":"The incidence of death or cardiac transplantation between those randomized to receive a RVPAS vs. a MBTS at the time of the Norwood operation.","time_frame":"11 years ± 1 year to 16 years"},{"outcome_type":"secondary","measure":"The exercise tolerance between those randomized to a RVPAS vs. a MBTS.","time_frame":"11 years ± 1 year to 16 years"},{"outcome_type":"secondary","measure":"The neurodevelopmental outcomes at 11 years of age in those randomized to a RVPAS vs. a MBTS","time_frame":"11 years ± 1 year"},{"outcome_type":"secondary","measure":"Develop risk stratification models for 1) cardiac outcomes, 2) transplant-free survival, and 3) neurodevelopmental outcomes.","time_frame":"11 years ± 1 year to 16 years"},{"outcome_type":"secondary","measure":"Collect specimens from subjects and their parents to further develop the biologic specimen repository.","time_frame":"11 years ± 1 year to 16 years"}]}
{"nct_id":"NCT02445313","start_date":"2015-06-30","enrollment":100,"brief_title":"Measuring Geographic Atrophy in AMD Patients Using the Nidek MP-3 Microperimetry Device","official_title":"Measuring Geographic Atrophy in AMD Patients Using the Nidek MP-3 Microperimetry Device","primary_completion_date":"2019-02-12","study_type":"Observational","rec_status":"Completed","completion_date":"2019-02-12","last_update":"2019-02-15","description":"The investigators would like to know if different imaging devices can improve the quality of images and visualization of imaged tissues. Also, the investigators would like to find out whether these changes are useful in the diagnosis and treatment of eye diseases. Using images of previous participants will allow us to demonstrate the advancement of different technologies, as well be used to allow comparisons between current technologies.","other_id":"NIDEKMP3","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","population":"Cohort A will consist of patients with AMD, recruited by PI when they come in to the\r\n        clinic, with whom we will conduct medical record review and imaging procedures, using one\r\n        of the research devices.\r\n\r\n        Cohort B will consist of control subject with no ocular problems, with whom no record\r\n        review will be conducted, but imaging will be conducted with study devices.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Normal, healthy participants and patients with AMD\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Those suffering from head, neck or other injury which makes them unable to position\r\n             themselves in head restraint for imaging\r\n\r\n          2. Participants who are unable to maintain retinal fixation on a specified target\r\n\r\n          3. Participants unable to achieve sufficient pupil dilation and alignment stability for\r\n             imaging to take place\r\n\r\n          4. Patients with media opacity which preclude high quality imaging will be excluded.\r\n\r\n          5. Exclusion criteria include vulnerable patients patients under 18, pregnant,\r\n             economically and educationally disadvantaged, decision impaired, or homeless people.\r\n             We exclude pregnant women because pregnancy often can alter eye anatomy.\r\n      ","sponsor":"Doheny Image Reading Center","sponsor_type":"Other","conditions":"Age-related Macular Degeneration (AMD)","interventions":[{"intervention_type":"Device","name":"Device: Nidek MP-3","description":"Nidek MP-3 device to be used to take images which will allow measurement of GA in patients with AMD"}],"outcomes":[{"outcome_type":"primary","measure":"Geographic Atrophy","time_frame":"1 year"}]}
{"nct_id":"NCT01530984","start_date":"2015-06-30","phase":"Phase 2","enrollment":0,"brief_title":"Ipilimumab and GMCSF Immunotherapy for Prostate Cancer","official_title":"Anti-CTLA4 Blockade Alone or Combined With Systemic GM-CSF for Prostate Cancer Immunotherapy","primary_completion_date":"2017-12-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2018-12-31","last_update":"2015-10-05","description":"This is an open-label randomized phase II study. Patients are randomized so as to achieve uniform patient cohorts treated on each regimen. Twenty-seven patients will be required per treatment arm, and a total of 54 prostate cancer patients will be required to complete this study. The study will assess for clinical activity by Prostate Specific Antigen (PSA) response, of both single agent ipilimumab and the combination of GM-CSF and ipilimumab in chemotherapy-nave patients with metastatic castrate resistant prostate cancer.","other_id":"CC# 12552","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Histologically confirmed, metastatic prostate cancer (positive bone scan and/or\r\n             measurable disease on CT scan and/or MRI of the abdomen and pelvis).\r\n\r\n          2. Progressive disease after androgen deprivation, as defined by PSA Working Group 237\r\n             and/or RECIST criteria.38 Patients must have disease progression by one or both of the\r\n             following:\r\n\r\n               -  For patients with measurable disease, progression is defined as at least a 20%\r\n                  increase in the sum of the longest diameter (LD) of target lesions or the\r\n                  appearance of one or more new lesions, as per RECIST criteria version 1.1\r\n\r\n               -  For patients with no measurable disease, a positive bone scan and elevated PSA\r\n                  will be required. PSA evidence for progressive prostate cancer consists of a PSA\r\n                  level of at least 2 ng/ml, which has risen on at least 2 successive occasions, at\r\n                  least 1 week apart. If the confirmatory PSA (#3) value is not greater (i.e., #3b)\r\n                  than the screening PSA (#2) value, then an additional test for rising PSA (#4)\r\n                  will be required to document progression\r\n\r\n               -  If no prior orchiectomy has been performed, patients must remain on LHRH agonist\r\n                  or antagonist therapy. Patients who are receiving an antiandrogen as part of\r\n                  primary androgen ablation must demonstrate disease progression following\r\n                  discontinuation of the antiandrogen, defined as two consecutive rising PSA\r\n                  values, obtained at least two weeks apart, or documented osseous or soft tissue\r\n                  progression. At least one of the PSA values must be obtained at least four weeks\r\n                  (flutamide) or six weeks (bicalutamide or nilutamide) after discontinuation\r\n\r\n          3. Laboratory requirements:\r\n\r\n               -  Absolute neutrophil count (ANC)  1500/L\r\n\r\n               -  Bilirubin < 1.5 x ULN\r\n\r\n               -  Hemoglobin  8 g/dL\r\n\r\n               -  PSA  2 ng/mL\r\n\r\n               -  Platelets > 100,000/L\r\n\r\n               -  AST and ALT < 2.5 x ULN\r\n\r\n               -  Creatinine clearance  60mL/min by the Cockcroft Gault equation Testosterone < 50\r\n                  ng/dL\r\n\r\n          4. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2 and life expectancy\r\n             > 12 weeks.\r\n\r\n          5. At least 18 years of age or older.\r\n\r\n          6. Patients receiving any other hormonal therapy, including any dose of megestrol acetate\r\n             (Megace), Proscar (finasteride), any herbal product known to decrease PSA levels (e.g.\r\n             Saw Palmetto, PC-SPES), or any systemic corticosteroid, must discontinue the agent for\r\n             at least four weeks prior to study treatment. Progressive disease as defined above\r\n             must be documented after discontinuation of any hormonal therapy (with the exception\r\n             of a LHRH agonist or antagonist).\r\n\r\n          7. Prior radiation therapy must be completed > 4 weeks prior to enrollment and the\r\n             patient must be recovered from all toxicity. Prior radiopharmaceuticals (strontium,\r\n             samarium) must be completed  8 weeks prior to enrollment.\r\n\r\n          8. Because of the unknown potential risk to a gamete and/or developing embryo from this\r\n             investigational therapy, patients must agree to use adequate contraception (barrier\r\n             method for males) for the duration of study participation, and for three months after\r\n             discontinuing therapy.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Prior chemotherapy for prostate cancer, with the exception of neoadjuvant\r\n             chemotherapy, because of the potential effect of chemotherapy on the immune system.\r\n\r\n          2. Prior investigational immunotherapy. Prior sipuleucel-T treatment is allowed but must\r\n             be completed at least 4 weeks prior to initiating treatment on this protocol.\r\n\r\n          3. Current treatment with systemic steroid therapy (inhaled/topical steroids are\r\n             acceptable). Systemic corticosteroids must be discontinued for at least 4 weeks prior\r\n             to first treatment.\r\n\r\n          4. History of autoimmune disease including, but not limited to:\r\n\r\n               -  Systemic lupus erythematosis (SLE), scleroderma, CREST syndrome, rheumatoid\r\n                  arthritis\r\n\r\n               -  Inflammatory bowel disease, celiac disease, primary biliary cirrhosis, autoimmune\r\n                  hepatitis\r\n\r\n               -  Dermatomyositis, polymyositis, giant cell arteritis\r\n\r\n               -  Autoimmune hemolytic anemia (AIHA), cryoglobulinemia, antiphospholipid antibody\r\n                  syndrome (APLS)\r\n\r\n               -  Diabetes mellitus type I, myasthenia gravis, Grave's disease\r\n\r\n               -  Wegener's granulomatosis or other vasculitis\r\n\r\n               -  A history of Hashimoto's thyroiditis, psoriasis, or eczema, any of which has been\r\n                  inactive for at least one year, or isolated Raynaud's phenomenon is acceptable\r\n\r\n          5. History or radiologic evidence of central nervous system metastases.\r\n\r\n          6. Medical or psychiatric illness that would preclude participation in the study or the\r\n             ability of patients to provide informed consent for themselves.\r\n\r\n          7. Cardiovascular disease that meets one of the following: congestive heart failure (New\r\n             York Heart Association Class III or IV), active angina pectoris, or recent myocardial\r\n             infarction (within the last 6 months).\r\n\r\n          8. Concurrent or prior malignancy except for the following:\r\n\r\n               -  Adequately treated basal or squamous cell skin cancer\r\n\r\n               -  Adequately treated stage I or II cancer from which the patient is currently in\r\n                  complete remission\r\n\r\n               -  Any other cancer from which the patient has been disease-free for 5 years\r\n\r\n          9. HIV or other history of immunodeficiency disorder.\r\n\r\n         10. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for\r\n             treatment of either a psychiatric or medical (e.g. infectious) illness.\r\n\r\n         11. Any underlying medical or psychiatric condition, which in the opinion of the\r\n             investigator will make the administration of ipilimumab hazardous or obscure the\r\n             interpretation of AEs, such as a condition associated with frequent diarrhea.\r\n\r\n         12. A history of prior treatment with ipilimumab or prior CD137 agonist or CTLA 4\r\n             inhibitor or agonist.\r\n      ","sponsor":"Lawrence Fong","sponsor_type":"Other","conditions":"Prostate Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Ipilimumab","description":"Ipilimumab 3 mg/kg on day 1 of a 28 day cycle for 6 cycles."},{"intervention_type":"Drug","name":"Drug: GM-CSF","description":"GM-CSF 250 mcg/m2 SQ on days 1-14 for 6 cycles."}],"outcomes":[{"outcome_type":"primary","measure":"To assess for clinical activity by PSA response, of both single agent ipilimumab and the combination of GM-CSF and ipilimumab in chemotherapy-naïve patients with metastatic castrate resistant prostate cancer.","time_frame":"12 weeks","description":"To assess for clinical activity by PSA (prostate-specific antigen) decline of both single agent ipilimumab in chemotherapy-naïve patients with metastatic castrate resistant prostate cancer (CRPC). The primary endpoint is the proportion of treated patients achieving a >30% decline in PSA."},{"outcome_type":"secondary","measure":"To evaluate the duration of PSA response and time to PSA progression. To quantify the frequency of immune toxicities. To evaluate T cell activation. To assess for clinical activity by objective response.","time_frame":"12 weeks"},{"outcome_type":"other","measure":"Assessment of circulating tumor cell (CTC) frequency","time_frame":"12 weeks","description":"To assess whether either treatment can modulate the frequency of circulating tumor cells (CTC). Modulation of the frequency of circulating tumor cells (CTC) will be measured from baseline to Cycle 6/off study visit of treatment."},{"outcome_type":"other","measure":"Assessment of the antigen specific immune responses induced with treatment","time_frame":"12 weeks","description":"Antigen specific immune responses will be measured by immunoblotting to detect the induction of IgG antibodies and by ELISA and ELISPOT assays to detect antibody and CD4 T cell responses, respectively, against candidate antigens in prostate cancer."}]}
{"nct_id":"NCT02682160","start_date":"2015-06-30","phase":"N/A","enrollment":38,"brief_title":"Pilot Study to Evaluate Daily Protein's Intake Following Bariatric Surgery by Using the Software Protein Assistant","official_title":"Pilot Study to Evaluate the Evolution of Daily Protein Intake in Obese Patients With Recent Bariatric Surgery, Using the Software Protein Assistant.","primary_completion_date":"2016-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-10-31","last_update":"2020-07-29","description":"The aim of this study is to evaluate the effect of the use of Protein Assistant on the daily protein intake in obese patients who underwent a bariatric surgery (in the 3 months following surgery).","other_id":"14 7310 02","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients who underwent a bariatric surgery a month +/- one week ago\r\n\r\n          -  Able to use a digital tablet\r\n\r\n          -  With internet access at home\r\n\r\n          -  Accepting modalities of formation and of digital tablet lending\r\n\r\n          -  When the average of protein intake is under 60g/j on a 3 days dietary record, one\r\n             month after bariatric surgery\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Lack of understanding of the use of a digital tablet\r\n\r\n          -  Under the protection of justice\r\n\r\n          -  Person participating to another trial\r\n\r\n          -  Pregnant or breast-feeding women\r\n      ","sponsor":"University Hospital, Toulouse","sponsor_type":"Other","conditions":"Obesity","interventions":[{"intervention_type":"Other","name":"Other: use of Protein Assistant","description":"The patient has to complete a dietary record every 2 weeks during 2 months (month 2 and 3 after surgery). The aim is to intake 60g per day. If the aim is not reached, Protein assistant suggests qualitative and/or quantitative solutions."}],"outcomes":[{"outcome_type":"primary","measure":"The primary outcome is the evolution of the average of protein's intake in grams/day (calculated on a 3 day's dietary record) between the first record and the last one (3 months after surgery)","time_frame":"3 months after surgery"},{"outcome_type":"secondary","measure":"the effect of Protein Assitant's use : evaluation of the % of patients reaching the goal of 60g per day of protein's intake 3 months after surgery and at each dietary record.","time_frame":"3 months after surgery"},{"outcome_type":"secondary","measure":"patient's satisfaction","time_frame":"3 months after surgery","description":"measured by the % of questionnaire response"}]}
{"nct_id":"NCT02403687","start_date":"2015-06-30","enrollment":300,"brief_title":"Prospective Analgesic Compound Efficacy (PACE) Study","official_title":"Prospective Analgesic Compound Efficacy (PACE) Study","primary_completion_date":"2016-12-31","study_type":"Observational [Patient Registry]","rec_status":"Completed","completion_date":"2017-02-28","last_update":"2018-02-01","description":"A 24-week observational prospective study on the efficacy of topical non-steroidal anti-inflammatory drugs for the relief of pain.","other_id":"1960fp-expr-201501","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":85,"population":"The patient population will be taken from the patients normally treated at 1960 Family\r\n        Practice. Patients not approached for the study will have known medical issues consistent\r\n        with the exclusion criteria. Patients who can meet the medical requirements of the\r\n        inclusion criteria for the study will be asked to participate. Patients who do not meet the\r\n        inclusion criteria, meet any of the exclusion criteria, or decline to be involved in the\r\n        study will be treated with traditional standard medical practices, and their standard of\r\n        care will not change in any way.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  4.1.1 Primary complaint or clinical findings of arthritis, tendonitis, gout,\r\n             synovitis, radiculopathy, muscle spasms, migraines, and/or idiopathic pain.\r\n\r\n        4.1.2 No new pain medications of any kind in the last 4 weeks. 4.1.3 Between the ages of\r\n        18-85yrs.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  4.2.1 Current or history of disease or disorders of the liver, kidneys,\r\n             gastrointestinal system, or cardiovascular system.\r\n\r\n        4.2.2 Blood test indicating kidney, liver, or cardiovascular function outside of normal\r\n        clinically accepted ranges. Blood test must be performed in the last 7 days.\r\n\r\n        4.2.3 Broken or inflamed skin, burns, open wounds, atopic dermatitis or eczema in the area\r\n        of pain where the compound cream and transdermal patch would be applied.\r\n\r\n        4.2.4 Women who are pregnant, nursing, or planning to become pregnant in the next 52-weeks.\r\n\r\n        4.2.5 Allergy/sensitivity to study drugs or their formulations. 4.2.6 Active drug or\r\n        alcohol use or dependence that, in the opinion of the site investigator, would interfere\r\n        with adherence to study requirements.\r\n\r\n        4.2.7 Serious illness (requiring systemic treatment and/or hospitalization) until subject\r\n        either completes therapy or is clinically stable on therapy, in the opinion of the site\r\n        investigator, for at least 14 days prior to study entry.\r\n\r\n        4.2.8 Inability or unwillingness of subject to give written informed consent.\r\n      ","sponsor":"Express Specialty Pharmacy","sponsor_type":"Other","conditions":"Arthritis|Tendonitis|Gout|Radiculopathy|Muscle Spasms|Synovitis|Migraine|Headache","interventions":[{"intervention_type":"Drug","name":"Drug: baclofen 2%","description":"compound topical cream"},{"intervention_type":"Drug","name":"Drug: Bupivacaine hydrochloride 1%","description":"compound topical cream"},{"intervention_type":"Drug","name":"Drug: Cyclobenzaprine hydrochloride 2%","description":"compound topical cream"},{"intervention_type":"Drug","name":"Drug: Diclofenac Sodium 3%","description":"compound topical cream"},{"intervention_type":"Drug","name":"Drug: Flurbiprofen 10%","description":"compound topical cream"},{"intervention_type":"Drug","name":"Drug: Gabapentin 6%","description":"compound topical cream"},{"intervention_type":"Drug","name":"Drug: Ketamine 10%","description":"compound topical cream"},{"intervention_type":"Drug","name":"Drug: Lidocaine 2%","description":"compound topical cream"},{"intervention_type":"Drug","name":"Drug: Prilocaine 2.5%","description":"compound topical cream"},{"intervention_type":"Drug","name":"Drug: Meloxicam 0.09%","description":"compound topical cream"},{"intervention_type":"Drug","name":"Drug: Sumatriptan 5%","description":"compound topical cream"},{"intervention_type":"Drug","name":"Drug: Tizanidine 0.1%","description":"compound topical cream"},{"intervention_type":"Drug","name":"Drug: Topiramate 2.5%","description":"compound topical cream"},{"intervention_type":"Drug","name":"Drug: Capsaicin, USP 0.0375%","description":"compound topical cream"},{"intervention_type":"Drug","name":"Drug: Menthol, NF 5.00 %","description":"compound topical cream"}],"outcomes":[{"outcome_type":"primary","measure":"subjective pain control as measured by a 10-point visual analog scale (VAS).","time_frame":"24 weeks"}]}
{"nct_id":"NCT02469246","start_date":"2015-06-29","phase":"Phase 3","enrollment":567,"brief_title":"Switch Study to Evaluate F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed on Regimens Containing ABC/3TC","official_title":"A Phase 3b, Randomized, Double-Blind, Switch Study to Evaluate F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed on Regimens Containing ABC/3TC","primary_completion_date":"2017-12-11","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-03-13","last_update":"2019-10-25","description":"The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of switching abacavir/lamivudine (ABC/3TC) fixed-dose combination (FDC) tablets to emtricitabine/tenofovir alafenamide (F/TAF) FDC tablets versus maintaining ABC/3TC in human immunodeficiency virus type 1 (HIV-1) infected adults who are virologically suppressed on regimens containing ABC/3TC.","other_id":"GS-US-311-1717","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Key Inclusion Criteria:\r\n\r\n          -  The ability to understand and sign a written informed consent form\r\n\r\n          -  On antiretroviral regimen containing ABC/3TC FDC in combination with one 3rd agent for\r\n              6 consecutive months prior to screening\r\n\r\n          -  Plasma HIV-1 RNA levels < 50 copies/mL for  6 months preceding the screening visit\r\n             (measured at least twice using the same assay) and without experiencing two\r\n             consecutive HIV-1 RNA above detectable levels after achieving a confirmed (two\r\n             consecutive) HIV-1 RNA below detectable levels on the current regimen in the past year\r\n\r\n          -  Plasma HIV-1 RNA should be < 50 copies/mL at the screening visit\r\n\r\n          -  Normal ECG\r\n\r\n          -  Estimated glomerular filtration rate (GFR)  50 mL/min according to the Cockcroft\r\n             Gault formula for creatinine clearance\r\n\r\n          -  Hepatic transaminases (AST and ALT)  5  upper limit of normal (ULN)\r\n\r\n          -  Total bilirubin  1.5 mg/dL, or normal direct bilirubin\r\n\r\n          -  Adequate hematologic function\r\n\r\n          -  Serum amylase  5  ULN\r\n\r\n          -  Females of childbearing potential and males must agree to utilize highly effective\r\n             contraception methods or be non-heterosexually active or practice sexual abstinence\r\n             from screening throughout the duration of study treatment and for 30 days following\r\n             the last dose of study drug\r\n\r\n        Key Exclusion Criteria:\r\n\r\n          -  A new AIDS-defining condition diagnosed within the 30 days prior to screening\r\n\r\n          -  Hepatitis B surface antigen (HBsAg) positive\r\n\r\n          -  Individuals experiencing decompensated cirrhosis\r\n\r\n          -  Individuals receiving ongoing treatment with bisphosphonate to treat bone disease (eg,\r\n             osteoporosis)\r\n\r\n          -  Pregnant or lactating females\r\n\r\n          -  Have an implanted defibrillator or pacemaker\r\n\r\n          -  Current alcohol or substance use judged by the investigator to potentially interfere\r\n             with study compliance\r\n\r\n          -  A history of malignancy within the past 5 years (prior to screening) or ongoing\r\n             malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or\r\n             resected, non-invasive cutaneous squamous carcinoma.\r\n\r\n          -  Active, serious infections (other than HIV-1 infection) requiring parenteral\r\n             antibiotic or antifungal therapy within 30 days prior to Day 1 Visit\r\n\r\n          -  Any other clinical condition or prior therapy that, in the opinion of the\r\n             investigator, would make the individual unsuitable for the study or unable to comply\r\n             with dosing requirements\r\n\r\n          -  Participation in any other clinical trial (including observational trials) without\r\n             prior approval\r\n\r\n          -  Medications excluded due to the potential for interaction with emtricitabine (FTC),\r\n             TAF, ABC or 3TC\r\n\r\n        Note: Other protocol defined Inclusion/Exclusion criteria may apply.\r\n      ","sponsor":"Gilead Sciences","sponsor_type":"Industry","conditions":"HIV-1 Infection","interventions":[{"intervention_type":"Drug","name":"Drug: F/TAF","description":"200/10 mg FDC tablet (with boosted 3rd ARV agents) or 200/25 mg FDC tablet (with unboosted 3rd ARV agents) administered orally once daily"},{"intervention_type":"Drug","name":"Drug: ABC/3TC","description":"600/300 mg FDC tablets administered orally once daily"},{"intervention_type":"Drug","name":"Drug: ABC/3TC Placebo","description":"Tablets administered orally once daily"},{"intervention_type":"Drug","name":"Drug: F/TAF Placebo","description":"Tablets administered orally once daily"},{"intervention_type":"Drug","name":"Drug: 3rd ARV agent","description":"An allowed 3rd ARV agent of the participant's pre-existing regimen may include one of the following boosted ARV agents: ritonavir boosted lopinavir (LPV/r), atazanavir (ATV) + ritonavir (RTV), ATV + cobicistat (COBI) or ATV/COBI FDC, darunavir (DRV) + RTV, DRV+COBI or DRV/COBI FDC; or, one of the following unboosted ARV agents: efavirenz (EFV), rilpivirine (RPV), raltegravir (RAL), dolutegravir (DTG), maraviroc (MVC), or nevirapine (NVP)."}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm","time_frame":"Week 48","description":"The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status."},{"outcome_type":"secondary","measure":"Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm","time_frame":"Week 96","description":"The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status."},{"outcome_type":"secondary","measure":"Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm","time_frame":"Week 48","description":"The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status."},{"outcome_type":"secondary","measure":"Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm","time_frame":"Week 96","description":"The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status."},{"outcome_type":"secondary","measure":"Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm","time_frame":"Week 48","description":"The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status."},{"outcome_type":"secondary","measure":"Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm","time_frame":"Week 96","description":"The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status."},{"outcome_type":"secondary","measure":"Change From Baseline in CD4 Cell Count at Week 48","time_frame":"Baseline; Week 48"},{"outcome_type":"secondary","measure":"Change From Baseline in CD4 Cell Count at Week 96","time_frame":"Baseline; Week 96"},{"outcome_type":"secondary","measure":"Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48","time_frame":"Baseline; Week 48"},{"outcome_type":"secondary","measure":"Percent Change From Baseline in Hip BMD at Week 96","time_frame":"Baseline; Week 96"},{"outcome_type":"secondary","measure":"Percent Change From Baseline in Spine BMD at Week 48","time_frame":"Baseline; Week 48"},{"outcome_type":"secondary","measure":"Percent Change From Baseline in Spine BMD at Week 96","time_frame":"Baseline; Week 96"}]}
{"nct_id":"NCT03281993","start_date":"2015-06-25","enrollment":76,"brief_title":"Apnea Tests as the Methods of Brain Death Diagnosis.","official_title":"Alternative Apnea Test as the Method of Brain Death Diagnosis .","primary_completion_date":"2015-06-25","study_type":"Observational","rec_status":"Completed","completion_date":"2017-06-25","last_update":"2017-09-14","description":"Apnea test (AT) is the most important clinical test performed usually at the end of brain death (BD) diagnosis procedure. Traditional insufflation apnea test (I-AT) cannot be completed in patients with extremely compromised lung function due to rapid blood desaturation and circulatory disturbances. Therefore the investigators decided to verify alternative AT options such as continuous positive airway pressure apnea test (CPAP-AT) in patients with good and poor baseline oxygenation, before implementing them in currently reviewed Polish BD criteria.","other_id":"KB-0012/116/13","observational_model":"Other","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Intubated adult ICU patients at the Intensive Care Unit of the Department of Anaesthesia\r\n        and Intensive Care teaching hospital at the Pomeranian Medical University in Szczecin\r\n        during Brain Death diagnosis","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  brain death diagnosis\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  no\r\n      ","sponsor":"Pomeranian Medical University Szczecin","sponsor_type":"Other","conditions":"Brain Death|Apnea|Pupillary Anomaly","interventions":[{"intervention_type":"Other","name":"Other: CPAP AT","description":"If the investigators observe rapid desaturation defined as a decline in O2 saturation below 85%; the CPAP apnea test (CPAP-AT) test was aborted."}],"outcomes":[{"outcome_type":"primary","measure":"Change from baseline arterial blood gases (ABG) during CPAP-AT","time_frame":"10 minutes","description":"After 2 hours from I-AT was performed the alternative AT by CPAP ventilation mode. Before CPAP-AT the patients were ventilated 100% oxygen. After then the ventilator parameters were modified to: 0 H2O of pressure support (PS), 10 cm H2O of PEEP, 6l/min of O2 flow and 0.2 l/min of sensitivity. Before the test and 10 minutes after then was taken blood probe to ABG and type of ventilation change to pretest settings. The test is considered valid if there is no respiratory activity despite the rise of PaCO2 above 60mmHg and over 20mmHg above the baseline. If the investigators observe rapid desaturation defined as a decline in O2 saturation below 85%, CPAP-AT was aborterd."}]}
{"nct_id":"NCT02371460","start_date":"2015-06-23","phase":"Phase 3","enrollment":800,"brief_title":"Maternal Omega-3 Supplementation to Reduce Bronchopulmonary Dysplasia","official_title":"Maternal Omega-3 Supplementation to Reduce BronchopulmonarY Dysplasia in Very Preterm Infants (MOBYDIck Trial)","primary_completion_date":"2019-04-25","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2023-09-30","last_update":"2021-07-14","description":"The aim of this randomized controlled trial is to determine whether docosahexaenoic acid (or DHA, an omega-3 lipid) supplementation in lactating mothers providing breast-milk to their infant born below 29 0/7 weeks of gestational age (GA) improves BPD-free survival at 36 weeks post-menstrual age (PMA). Half of participants will receive docosahexaenoic acid (DHA), an omega-3 lipid, while the other half will receive a placebo.","other_id":"2015-2144, B14-09-2144-21","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"Female","minimum_age":16,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age more than or equal to 16 years\r\n\r\n          2. Pre-term delivery (230/7- 286/7 weeks gestation)\r\n\r\n          3. No contraindication to breastfeeding\r\n\r\n          4. Subject intends to provide own breast milk to infant\r\n\r\n          5. Randomization before or at 72 hours post delivery\r\n\r\n        Exclusion Criteria:\r\n\r\n        MOTHERS\r\n\r\n          1. Mother is taking > 250 mg of daily DHA supplementation for last 3 months\r\n\r\n          2. Mother who is currently enrolled or has participated in another clinical trial in\r\n             which she had received an investigational drug or intervention within 3 months of the\r\n             date of randomization (unless approved by the Trial Coordinating Centre)\r\n\r\n          3. Inability to comprehend and comply with study requirements\r\n\r\n          4. Participation in this study in a previous pregnancy\r\n\r\n        INFANTS\r\n\r\n          1. Significant congenital malformations in the infant (or one of the infants in case of\r\n             multiple pregnancy)\r\n\r\n          2. Infant (or one of the infants in case of multiple pregnancy) who is currently enrolled\r\n             in another clinical trial (unless approved by the Trial Coordinating Centre)\r\n      ","sponsor":"CHU de Quebec-Universite Laval","sponsor_type":"Other","conditions":"Bronchopulmonary Dysplasia|Child Development|Neonatal and Perinatal Conditions","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: DHA-rich algal oil","description":"Mothers will receive a DHA-rich algal oil treatment (400 mg DHA per capsule) three times a day before meals from randomization (<72 hours post-delivery) until the infant reaches 36 weeks PMA."},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Placebo","description":"Mothers will receive a placebo capsule three times a day before meals from randomization (<72 hours post-delivery) until the infant reaches 36 weeks PMA."}],"outcomes":[{"outcome_type":"primary","measure":"BPD-free survival","time_frame":"at 36 weeks PMA","description":"Defined as (1- combined rate of mortality and BPD in survivors). Mortality is defined as death from any cause between randomization and 36 weeks PMA. Physiological BPD is defined as the need for oxygen and/or ventilation at 36 weeks"},{"outcome_type":"secondary","measure":"Mortality","time_frame":"until 36 weeks PMA","description":"Mortality is defined as death from any cause."},{"outcome_type":"secondary","measure":"Bronchopulmonary Dysplasia (BPD)","time_frame":"at 36 weeks PMA","description":"Physiological BPD is defined as the need for oxygen and/or ventilation at 36 weeks"},{"outcome_type":"secondary","measure":"Mild, moderate and severe BPD","time_frame":"at 36 weeks PMA","description":"Defined according to the severity-based National Institute of Child Health & Development (NICHD) criteria"},{"outcome_type":"secondary","measure":"Necrotizing enterocolitis stage 2 or greater","time_frame":"until first discharge home or 40 weeks PMA","description":"According to Bell criteria"},{"outcome_type":"secondary","measure":"Any intraventricular hemorrhage and severe grade III or IV","time_frame":"from randomization until discharge home or 40 weeks PMA","description":"According to Papile's classification; Screening is performed as routine care;"},{"outcome_type":"secondary","measure":"Periventricular leucomalacia","time_frame":"until discharge home or 40 weeks PMA","description":"Screening is performed as routine care"},{"outcome_type":"secondary","measure":"Sepsis","time_frame":"until discharge home or 40 weeks PMA","description":"Defined as culture-positive (blood or cerebrospinal fluid) and/or clinical infection (with antibiotics ≥5 days)"},{"outcome_type":"secondary","measure":"Retinopathy of prematurity (any or threshold)","time_frame":"until first discharge home or 40 weeks PMA","description":"According to the assessment by ophthalmologist, collected in the medical chart"},{"outcome_type":"secondary","measure":"Patent ductus arterious","time_frame":"until first discharge home or 40 weeks PMA","description":"Requiring surgical ligation"},{"outcome_type":"secondary","measure":"Significant cholestasis","time_frame":"until first discharge home or 36 weeks PMA","description":"Defined as conjugated serum bilirubin ≥34 µmol/L"},{"outcome_type":"secondary","measure":"Child anthropometry","time_frame":"until first discharge home or 36 weeks PMA","description":"Weight, length and cranial circumference as routinely measured and collected in the chart"},{"outcome_type":"secondary","measure":"Neuro-development","time_frame":"at 18-22 months corrected age (CA)","description":"Defined as mean cognitive, language and motor composite scores of the Bayley Scale of Infant and Toddler Development's third edition (Bayley-III)"},{"outcome_type":"other","measure":"Supplemental Oxygen","time_frame":"at 36 weeks PMA","description":"Defined as need for supplemental oxygen (mL/min flow or FiO2)"},{"outcome_type":"other","measure":"Duration of supplemental oxygen or respiratory support","time_frame":"until first discharge home or 36 weeks PMA","description":"Defined as cumulative days on supplemental oxygen or respiratory support"},{"outcome_type":"other","measure":"Hospitalization duration","time_frame":"until first discharge home or 40 weeks PMA","description":"Defined as number of days in hospital"},{"outcome_type":"other","measure":"Cerebral palsy","time_frame":"at 18-22 months CA","description":"will be ascertained using standard definitions and severity classified using the Gross Motor Function Classification System"},{"outcome_type":"other","measure":"Child anthropometry","time_frame":"at 18-22 months CA","description":"Weight, length and cranial circumference"},{"outcome_type":"other","measure":"Deafness","time_frame":"until 18-22 months CA","description":"Hearing tests will be performed by audiologists according to standard practice"},{"outcome_type":"other","measure":"Blindness (yes/no), visual acuity +/- strabismus","time_frame":"until 18-22 months CA","description":"According to ophthalmologist or orthoptist examination"},{"outcome_type":"other","measure":"Death since 40weeks","time_frame":"from first discharge or 40 weeks PMA until 18-22 months CA","description":"Any cause"},{"outcome_type":"other","measure":"Number of hospital readmissions","time_frame":"From first discharge until 18-22 months CA","description":"Assessment by standardized interview"},{"outcome_type":"other","measure":"Respiratory morbidities","time_frame":"until 18-22 months CA","description":"Physical examination will be performed by a pediatrician and a standardized general health questionnaire (including respiratory health outcomes) will be completed. Respiratory health outcomes will include respiratory symptoms, hospital admissions for respiratory deteriorations, use of inhaled therapies."},{"outcome_type":"other","measure":"Maternal Satisfaction","time_frame":"at 36 weeks PMA","description":"Assessment by a questionnaire"},{"outcome_type":"other","measure":"Maternal significant episodes of bleeding requiring treatment or hospitalization until 4 weeks post intervention","time_frame":"from date of randomization up to 40 weeks PMA","description":"Assessment by standardized interview"},{"outcome_type":"other","measure":"Acceptability of a study at 8 years of age involving brain magnetic resonance imaging (MRI)","time_frame":"at 60 months CA","description":"Semistructured interviews framed using the theoretical domains framework will be conducted to identify potential barriers and facilitators that may influence participation in a follow-up study with brain MRI at 8 years of age.\r\nA subsample of n=194 children will be eligible to participate if they have not died or withdrawn from the trial and if they were born and enrolled at the following centres:\r\nCHU de Québec-Université Laval\r\nCentre Hospitalier Universitaire de Sherbrooke, CHUS\r\nCHU Sainte-Justine\r\nJewish General Centre\r\nMcGill University Health Center, Glen Site, Montreal Children's Hospital"},{"outcome_type":"other","measure":"Child health-related quality of life","time_frame":"at 60 months CA","description":"Assessed by the Pediatric Quality of Life Inventory (PedsQL).\r\nA subsample of n=194 children will be eligible to participate if they have not died or withdrawn from the trial and if they were born and enrolled at the following centres:\r\nCHU de Québec-Université Laval\r\nCentre Hospitalier Universitaire de Sherbrooke, CHUS\r\nCHU Sainte-Justine\r\nJewish General Centre\r\nMcGill University Health Center, Glen Site, Montreal Children's Hospital"},{"outcome_type":"other","measure":"Behavioral problems","time_frame":"at 60 months CA","description":"Assessed by the Total Difficulties scores, Externalizing and Internalizing scores of the Strengths and Difficulties Questionnaire.\r\nA subsample of n=194 children will be eligible to participate if they have not died or withdrawn from the trial and if they were born and enrolled at the following centres:\r\nCHU de Québec-Université Laval\r\nCentre Hospitalier Universitaire de Sherbrooke, CHUS\r\nCHU Sainte-Justine\r\nJewish General Centre\r\nMcGill University Health Center, Glen Site, Montreal Children's Hospital"},{"outcome_type":"other","measure":"Executive function","time_frame":"at 60 months CA","description":"Assessed by the Global executive composite score of the Behavior Rating Inventory of Executive Function - Preschool.\r\nA subsample of n=194 children will be eligible to participate if they have not died or withdrawn from the trial and if they were born and enrolled at the following centres:\r\nCHU de Québec-Université Laval\r\nCentre Hospitalier Universitaire de Sherbrooke, CHUS\r\nCHU Sainte-Justine\r\nJewish General Centre\r\nMcGill University Health Center, Glen Site, Montreal Children's Hospital"},{"outcome_type":"other","measure":"Global developmental delay","time_frame":"at 60 months CA","description":"Assessed by the 5 developmental areas of the Ages and Stages Questionnaire.\r\nA subsample of n=194 children will be eligible to participate if they have not died or withdrawn from the trial and if they were born and enrolled at the following centres:\r\nCHU de Québec-Université Laval\r\nCentre Hospitalier Universitaire de Sherbrooke, CHUS\r\nCHU Sainte-Justine\r\nJewish General Centre\r\nMcGill University Health Center, Glen Site, Montreal Children's Hospital"},{"outcome_type":"other","measure":"Exposure and impact of the COVID-19 pandemic","time_frame":"at 60 months CA","description":"Impact on the home environment, quality of life, development and behavioral and executive functioning.\r\nA subsample of n=194 children will be eligible to participate if they have not died or withdrawn from the trial and if they were born and enrolled at the following centres:\r\nCHU de Québec-Université Laval\r\nCentre Hospitalier Universitaire de Sherbrooke, CHUS\r\nCHU Sainte-Justine\r\nJewish General Centre\r\nMcGill University Health Center, Glen Site, Montreal Children's Hospital"}]}
{"nct_id":"NCT02348320","start_date":"2015-06-17","phase":"Phase 1","enrollment":18,"brief_title":"Safety and Immunogenicity of a Personalized Polyepitope DNA Vaccine Strategy in Breast Cancer Patients With Persistent Triple-Negative Disease Following Neoadjuvant Chemotherapy","official_title":"A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of a Personalized Polyepitope DNA Vaccine Strategy in Breast Cancer Patients With Persistent Triple-Negative Disease Following Neoadjuvant Chemotherapy","primary_completion_date":"2020-03-12","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-03-12","last_update":"2020-07-01","description":"This is a phase 1 open-label study to evaluate the safety and immunogenicity of a personalized polyepitope DNA vaccine strategy. The personalized polyepitope DNA vaccines will be formulated as naked plasmid DNA vaccines. The hypothesis of this study is that personalized polyepitope DNA vaccines will be safe for human administration and capable of generating measurable CD8 T cell responses to mutant tumor-specific antigens.","other_id":"201505074","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically confirmed diagnosis of invasive breast cancer.\r\n\r\n          -  ER and PR less than Allred score of 3 or less than 1% positive staining cells in the\r\n             invasive component of the tumor. Patients not meeting this pathology criteria, but\r\n             have been clinically treated as having TNBC, can be enrolled at PI discretion.\r\n\r\n          -  HER2 negative by FISH or IHC staining 0 or 1+.\r\n\r\n          -  Consented for genome sequencing and dbGAP-based data sharing and has provided or will\r\n             provide germline and tumor DNA samples of adequate quality for sequencing. Fresh\r\n             tissue is preferred (from biopsy at the time of port placement) but archival tissue is\r\n             allowed\r\n\r\n          -  Clinical stage T1c-T4c, any N, M0 primary tumor by AJCC 7th edition clinical staging\r\n             prior to neoadjuvant chemotherapy, with residual invasive breast cancer after\r\n             neoadjuvant therapy. If the patient has invasive cancer in the contralateral breast,\r\n             she is not eligible for this study.\r\n\r\n          -  At least 18 years of age. Eastern Cooperative Oncology Group (ECOG) performance status\r\n             2\r\n\r\n          -  Adequate organ and marrow function no more than 14 days prior to registration as\r\n             defined below:\r\n\r\n               -  WBC  3,000/L\r\n\r\n               -  absolute neutrophil count 1,500/L\r\n\r\n               -  platelets  100,000/L\r\n\r\n               -  total bilirubin  2.5 X institutional upper limit of normal\r\n\r\n               -  AST/ALT  2.5 X institutional upper limit of normal\r\n\r\n               -  creatinine  1.5 X institutional upper limit of normal\r\n\r\n          -  Women of reproductive potential must agree to use adequate contraception (hormonal or\r\n             barrier method of birth control; abstinence) prior to study entry and for the duration\r\n             of study participation.\r\n\r\n          -  Able to understand and willing to sign an IRB-approved written informed consent\r\n             document.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Evidence of progressive breast cancer within the last 30 days.\r\n\r\n          -  Received chemotherapy, radiotherapy, or biologic therapy within the last 30 days\r\n             (neoadjuvant chemotherapy excluded).\r\n\r\n          -  Experiencing any clinically significant adverse events above Grade 1 (according to\r\n             CTCAE 4.0) due to agents administered more than 30 days earlier. However, patients\r\n             with Grade 2 Alopecia will be considered eligible.\r\n\r\n          -  Receiving any other investigational agent(s) or has received an investigational agent\r\n             within the last 30 days.\r\n\r\n          -  Known metastatic disease.\r\n\r\n          -  Invasive cancer in the contralateral breast.\r\n\r\n          -  Known allergy, or history of serious adverse reaction to vaccines such as anaphylaxis,\r\n             hives, or respiratory difficulty.\r\n\r\n          -  Uncontrolled intercurrent illness including, but not limited to ongoing or active\r\n             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac\r\n             arrhythmia (including sinus bradycardia), or psychiatric illness/social situation that\r\n             would limit compliance with study requirements.\r\n\r\n          -  Prior or currently active autoimmune disease requiring management with\r\n             immunosuppression. This includes inflammatory bowel disease, ulcerative colitis,\r\n             Crohn's disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis,\r\n             hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis, systemic\r\n             lupus erythematosus, Sjogren's syndrome, sarcoidosis, or other rheumatologic disease\r\n             or any other medical condition or use of medication (e.g., corticosteroids) which\r\n             might make it difficult for the patient to complete the full course of treatments or\r\n             to generate an immune response to vaccines. Asthma or chronic obstructive pulmonary\r\n             disease that does not require daily systemic corticosteroids is acceptable. Any\r\n             patients receiving steroids should be discussed with the PI to determine if eligible.\r\n\r\n          -  Pregnant or breastfeeding. A negative serum pregnancy test is required no more than 7\r\n             days before study entry.\r\n\r\n          -  The patient with a previous history of non-breast malignancy is eligible for this\r\n             study only if the patient meets the following criteria for a cancer survivor. A cancer\r\n             survivor is eligible provided the following criteria are met: (1) patient has\r\n             undergone potentially curative therapy for all prior malignancies, (2) patients have\r\n             been considered disease free for at least 1 year (with the exception of basal cell or\r\n             squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix).\r\n\r\n          -  Patient must have no active major medical or psychosocial problems that could be\r\n             complicated by study participation.\r\n\r\n          -  Known HIV-positive status. These patients are ineligible because of the potential\r\n             inability to generate an immune response to vaccines.\r\n\r\n          -  Subjects with a strong likelihood of non-adherence such as difficulties in adhering to\r\n             follow-up schedule due to geographic distance from the Siteman Cancer Center should\r\n             not knowingly be registered.\r\n\r\n          -  Individuals in whom a skinfold measurement of the cutaneous and subcutaneous tissue\r\n             for eligible injection sites (left and right medial deltoid region) exceeds 40 mm.\r\n\r\n          -  Individuals in whom the ability to observe possible local reactions at the eligible\r\n             injection sites (deltoid region) is, in the opinion of the investigator, unacceptably\r\n             obscured due to a physical condition or permanent body art.\r\n\r\n          -  Therapeutic or traumatic metal implant in the skin or muscle of either deltoid region.\r\n\r\n          -  Acute or chronic, clinically significant hematologic, pulmonary, cardiovascular, or\r\n             hepatic or renal functional abnormality as determined by the investigator based on\r\n             medical history, physical examination, EKG, and/or laboratory screening test\r\n\r\n          -  Any chronic or active neurologic disorder, including seizures and epilepsy, excluding\r\n             a single febrile seizure as a child\r\n\r\n          -  Syncopal episode within 12 months of screening\r\n\r\n          -  Current use of any electronic stimulation device, such as cardiac demand pacemakers,\r\n             automatic implantable cardiac defibrillator, nerve stimulators, or deep brain\r\n             stimulators.\r\n      ","sponsor":"Washington University School of Medicine","sponsor_type":"Other","conditions":"Triple Negative Breast Cancer|Triple-Negative Breast Cancer|Triple Negative Breast Neoplasms","interventions":[{"intervention_type":"Biological","name":"Biological: Personalized polyepitope DNA vaccine"}],"outcomes":[{"outcome_type":"primary","measure":"Safety of the personalized polyepitope DNA vaccine strategy, measured by both clinical observation and laboratory evaluation","time_frame":"52 weeks","description":"Assessment of plasmid DNA safety will include both clinical observation and laboratory evaluation. Safety will be closely monitored after injection with eight or more clinical and laboratory assessments in the first 24 weeks of the trial. The following parameters will be assessed following vaccination:\r\nLocal signs and symptoms\r\nSystemic signs and symptoms\r\nLaboratory evaluations, including blood counts and serum chemistries\r\nAdverse, and serious adverse events"},{"outcome_type":"secondary","measure":"Immunogenicity of the personalized polyepitope DNA vaccine strategy, measured by ELISPOT analysis, a surrogate for CD8 T cell function, and multiparametric flow cytometry","time_frame":"52 weeks","description":"Immunogenicity will be measured by ELISPOT analysis, a surrogate for CD8 T cell function, and multiparametric flow cytometry. In both assays the quantity and quality of antigen-specific CD8 T cells is determined; the ELISPOT analysis is based on measuring the frequencies of IFN-γ producing T cells in response to polyepitope antigen, whereas the multiparametric flow cytometry assesses phenotypic as well as functional characteristics of epitope-specific CD8 T cells. In the proposed study, blood samples will be collected at multiple time points (n=8) and PBMC isolated and cryopreserved. Upon completion of the vaccination protocol, all samples will be analyzed simultaneously in order to minimize assay-to-assay variation."}]}
{"nct_id":"NCT03137355","start_date":"2015-06-17","enrollment":200,"brief_title":"The Leigh Syndrome Registry","official_title":"The International Database for Leigh Syndrome","primary_completion_date":"2025-06-17","study_type":"Observational [Patient Registry]","rec_status":"Recruiting","completion_date":"2025-06-17","last_update":"2020-11-09","description":"The purpose of this study is to develop a database containing clinical and laboratory information for patients with Leigh syndrome. The goal is to provide a greater understanding of Leigh syndrome allowing further characterization of this disease.","other_id":"HSC-MS-14-0907","observational_model":"Case-Only","time_perspective":"Other","sampling_method":"Non-Probability Sample","gender":"All","maximum_age":100,"population":"People with a diagnosis of Leigh syndrome.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  All participants with a diagnosis of Leigh syndrome will be invited to participate\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  People without Leigh syndrome\r\n      ","sponsor":"The University of Texas Health Science Center, Houston","sponsor_type":"Other","conditions":"Leigh Syndrome|Leigh Disease|Leigh's Necrotizing Encephalopathy|Subacute Necrotizing Encephalomyopathy|Subacute Necrotizing Encephalomyelopathy","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Phenotypical characteristics of Leigh syndrome","time_frame":"10 years","description":"The goal of this project is to collect longitudinal data on the natural history of Leigh syndrome."}]}
{"nct_id":"NCT02414139","start_date":"2015-06-11","phase":"Phase 2","enrollment":373,"brief_title":"Clinical Study of Oral cMET Inhibitor INC280 in Adult Patients With EGFR Wild-type Advanced Non-small Cell Lung Cancer (Geometry Mono-1)","official_title":"A Phase II, Multicenter Study of Oral cMET Inhibitor INC280 in Adult Patients With EGFR Wild-type (wt), Advanced Non-small Cell Lung Cancer (NSCLC)(Geometry Mono-1)","primary_completion_date":"2023-02-07","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2023-03-23","last_update":"2021-09-02","description":"A phase II study to evaluate antitumor activity of oral cMET inhibitor INC280 in adult patients with EGFR wild-type, advanced non-small cell lung cancer (NSCLC) as measured by overall response rate (ORR). The study will also evaluate safety and pharmacokinetics of INC280.","other_id":"CINC280A2201","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Stage IIIB or IV NSCLC (any histology) at the time of study entry\r\n\r\n          -  Histologically or cytologically confirmed diagnosis of NSCLC that is:\r\n\r\n               1. EGFR wt as per patient standard of care by a validated test\r\n\r\n               2. AND ALK-negative rearrangement as part of the patient standard of care by a\r\n                  validated test\r\n\r\n               3. AND (by central assessment) either:\r\n\r\n                    -  Cohort 1: Pre-treated patients with cMET GCN  6 or\r\n\r\n                    -  Cohort 2: Pre-treated patients with cMET GCN 4 and < 6, or\r\n\r\n                    -  Cohort 3: Pre-treated patients with cMET GCN < 4, or\r\n\r\n                    -  Cohort 4: Pre-treated patients with cMET mutations regardless of cMET GCN,\r\n                       or\r\n\r\n                    -  Cohort 5: Treatment-nave patients with cMET dysregulation, or\r\n\r\n                    -  Cohort 6: Pre-treated patients with either cMET GCN  10 without cMET\r\n                       mutations or cMET mutations regardless of cMET GCN, or\r\n\r\n                    -  Cohort 7: Treatment-nave patients with cMET mutations regardless of cMET\r\n                       GCN\r\n\r\n          -  To be eligible for Cohorts 1-4, patients must have failed one or two prior lines of\r\n             systemic therapy for advanced/metastatic disease\r\n\r\n          -  To be eligible for Cohort 6, patients must have failed one prior line of systemic\r\n             therapy for advanced/metastatic disease\r\n\r\n          -  To be eligible for Cohort 5 and Cohort 7, patients must not have received any systemic\r\n             therapy for advanced/metastatic disease\r\n\r\n          -  At least one measurable lesion as defined by RECIST 1.1\r\n\r\n          -  Patients must have recovered from all toxicities related to prior anticancer therapies\r\n             to grade  1 (CTCAE v 4.03). Patients with any grade of alopecia are allowed to enter\r\n             the study.\r\n\r\n          -  Patients must have adequate organ function\r\n\r\n          -  ECOG performance status (PS) of 0 or 1 Details and other protocol-defined inclusion\r\n             criteria may apply\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior treatment with crizotinib, or any other cMET or HGF inhibitor\r\n\r\n          -  Patients with characterized EGFR mutations that predict sensitivity to EGFR therapy,\r\n             including, but not limited to exon 19 deletions and exon 21 mutations\r\n\r\n          -  Patients with characterized ALK-positive rearrangement\r\n\r\n          -  Clinically significant, uncontrolled heart diseases.\r\n\r\n          -  Patients receiving treatment with medications that cannot be discontinued at least 1\r\n             week prior to first INC280 treatment and for the duration of the study:\r\n\r\n               -  Strong inducers of CYP3A4\r\n\r\n          -  Impairment of GI function or GI disease that may significantly alter the absorption of\r\n             INC280\r\n\r\n          -  Patients receiving treatment with any enzyme-inducing anticonvulsant\r\n\r\n          -  Applicable to Cohorts 1-4 and Cohort 6 only: Previous anti-cancer and investigational\r\n             agents within 4 weeks or  5 x half-life of the agent (whichever is longer) before\r\n             first dose\r\n\r\n          -  Pregnant or nursing women\r\n\r\n          -  Women of child-bearing potential, unless they are using highly effective methods of\r\n             contraception\r\n\r\n          -  Sexually active males unless they use a condom during intercourse\r\n\r\n          -  Presence or history of interstitial lung disease or interstitial pneumonitis,\r\n             including clinically significant radiation pneumonitis\r\n\r\n        Other protocol-defined exclusion criteria may apply\r\n      ","sponsor":"Novartis Pharmaceuticals","sponsor_type":"Industry","conditions":"Carcinoma, Non-Small-Cell Lung","interventions":[{"intervention_type":"Drug","name":"Drug: INC280 (capmatinib)"}],"outcomes":[{"outcome_type":"primary","measure":"Overall Response Rate (ORR)","time_frame":"at least 18 weeks","description":"Proportion of patients with a best overall response defined as complete response (CR) or partial response (PR) by Blinded Independent Review Committee (BIRC) assessment per RECIST 1.1"},{"outcome_type":"secondary","measure":"Duration of Response (DOR) - Key Secondary","time_frame":"at least 18 weeks","description":"Calculated as the time from the date of the first documented CR or PR by Blinded Independent Review Committee (BIRC) per RECIST 1.1 to the first documented progression or death due to any cause for patients with PR or CR."},{"outcome_type":"secondary","measure":"Overall Response Rate (ORR)","time_frame":"at least 18 weeks","description":"ORR (complete response (CR)+ partial response (PR)) per RECIST 1.1 by investigator assessment"},{"outcome_type":"secondary","measure":"Duration of Response (DOR)","time_frame":"at least 18 weeks","description":"DOR per RECIST 1.1 by investigator assessment"},{"outcome_type":"secondary","measure":"Time to Response (TTR)","time_frame":"at least 18 weeks","description":"TTR per RECIST 1.1 both by BIRC and investigator assessment"},{"outcome_type":"secondary","measure":"Disease Control Rate (DCR)","time_frame":"at least 18 weeks","description":"DCR per RECIST 1.1 both by BIRC and investigator assessment"},{"outcome_type":"secondary","measure":"Progression-free Survival (PFS)","time_frame":"at least 18 weeks","description":"PFS per RECIST 1.1 both by BIRC and investigator assessment"},{"outcome_type":"secondary","measure":"Overall Survival (OS)","time_frame":"at least 18 weeks","description":"OS, defined as time from first dose of INC280 to death due to any cause"},{"outcome_type":"secondary","measure":"Number of patients with incidence of adverse events and serious adverse events, change in vital signs, laboratory results (hematology, blood chemistry, and urinalysis) and ECG.","time_frame":"at least 18 weeks","description":"Safety of INC280"},{"outcome_type":"secondary","measure":"Cmax, Cmin and plasma concentration-time profiles of INC280","time_frame":"6 weeks","description":"Pharmacokinetics of INC280 and metabolite CMN288"}]}
{"nct_id":"NCT02466516","start_date":"2015-06-08","phase":"Phase 2","enrollment":72,"brief_title":"Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Adults With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3","official_title":"A Phase 2, Randomized, Open Label Study Evaluating the Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Subjects With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3","primary_completion_date":"2016-10-11","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-10-11","last_update":"2019-06-26","description":"The primary objective of this study is to evaluate the safety and tolerability of GS-4997 (selonsertib [SEL]) alone or in combination with simtuzumab (SIM) in adults with nonalcoholic steatohepatitis (NASH) and fibrosis stages F2-F3. Participants will be randomized in a 2:2:1:1:1 ratio to 1 of 5 study treatment arms.","other_id":"GS-US-384-1497","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Key Inclusion Criteria:\r\n\r\n          -  Males and non-pregnant, non-lactating females\r\n\r\n          -  Evidence of NASH with fibrosis on biopsy\r\n\r\n        Key Exclusion Criteria:\r\n\r\n          -  Cirrhosis of the liver (e.g. Brunt/Kleiner score of F4)\r\n\r\n          -  Other causes of liver disease including viral hepatitis and alcoholic liver disease\r\n\r\n          -  Any history of decompensated liver disease, including ascites, hepatic encephalopathy\r\n             or variceal bleeding\r\n\r\n          -  History of liver transplantation\r\n\r\n          -  Alcohol consumption greater than 21 oz/week for males or 14 oz/week for females (1\r\n             oz/30 mL of alcohol is present in 1 12 oz/360 mL beer, 1 4 oz/120 mL glass of wine,\r\n             and a 1 oz/30 mL measure of 40% proof alcohol)\r\n\r\n        Note: Other protocol defined Inclusion/Exclusion criteria may apply.\r\n      ","sponsor":"Gilead Sciences","sponsor_type":"Industry","conditions":"Non-Alcoholic Steatohepatitis (NASH)","interventions":[{"intervention_type":"Drug","name":"Drug: SEL","description":"SEL tablet administered orally once daily"},{"intervention_type":"Biological","name":"Biological: SIM","description":"Simtuzumab (SIM) 125 mg/mL single-dose vials administered subcutaneously once weekly"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Any Grade ≥ 1 Laboratory Abnormality","time_frame":"Baseline up to last dose plus 30 days (up to Week 28)","description":"Treatment-emergent events began on or after the first dosing date up to 30 days after the last dosing date or led to premature discontinuation of study drug. The severity of laboratory abnormalities was assessed as Grade 0, 1 (mild), 2 (moderate), 3 (severe), or 4 (potentially life threatening) using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03."},{"outcome_type":"primary","measure":"Number of Participants Who Prematurely Discontinued Study Drug or Study Due to Adverse Events","time_frame":"Baseline up to follow up visit (Week 28)"}]}
{"nct_id":"NCT02746991","start_date":"2015-06-02","phase":"Phase 3","enrollment":153,"brief_title":"Safety and Efficacy Study of a FAI Insert in Subjects With Chronic Non-infectious Posterior Uveitis","official_title":"A Multi-center, Controlled, Safety and Efficacy Study of a Fluocinolone Acetonide Intravitreal (FAI) Insert in Subjects With Chronic Non-infectious Uveitis Affecting the Posterior Segment of the Eye","primary_completion_date":"2019-10-04","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-10-04","last_update":"2020-07-21","description":"Phase 3, multi-center, randomized, masked, controlled study to evaluate the safety and efficacy of an injectable fluocinolone acetonide intravitreal (FAI) insert for the management of subjects with chronic non-infectious uveitis affecting the posterior segment of the eye. Patients will be randomized to receive either a sham injection or the FAI insert and will be observed for three years following treatment.","other_id":"PSV-FAI-005","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or non pregnant female at least 18 years of age at time of consent\r\n\r\n          -  One or both eyes having a history of recurrent non-infectious uveitis affecting the\r\n             posterior segment of the eye with or without anterior uveitis > 1 year duration\r\n\r\n          -  At the time of enrollment (Day 1), study eye has < 10 anterior chamber cells/High\r\n             Power Field (HPF) and a vitreous haze  grade 2.\r\n\r\n          -  Visual acuity of study eye is at least 15 letters on the Early Treatment Diabetic\r\n             Retinopathy Study (ETDRS) chart\r\n\r\n          -  Subject is not planning to undergo elective ocular surgery during the study\r\n\r\n          -  Subject has ability to understand and sign the Informed Consent Form\r\n\r\n          -  Subject is willing and able to comply with scheduled visits, treatment plan,\r\n             laboratory tests and other study procedures\r\n\r\n          -  During the 12 months prior to enrollment (Day 1), the study eye has either received\r\n             treatment:\r\n\r\n               -  systemic corticosteroid or other systemic therapies given for at least 3 months,\r\n                  and/or\r\n\r\n               -  at least 2 intra- or peri-ocular administrations of corticosteroid for management\r\n                  of uveitis\r\n\r\n        OR the study eye has experienced recurrence:\r\n\r\n         at least 2 separate recurrences of uveitis requiring systemic, intra- or peri-ocular\r\n        injection of corticosteroid\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Allergy to fluocinolone acetonide or any component of the Fluocinolone Acetonide\r\n             Intravitreal (FAI) insert\r\n\r\n          -  History of posterior uveitis only that is not accompanied by vitritis or macular edema\r\n\r\n          -  History of iritis only and no vitreous cells, anterior chamber cells or vitreous haze\r\n\r\n          -  Uveitis with infectious etiology\r\n\r\n          -  Vitreous hemorrhage\r\n\r\n          -  Intraocular inflammation associated with a condition other than noninfectious uveitis\r\n             (e.g. intraocular lymphoma)\r\n\r\n          -  Ocular malignancy in either eye, including choroidal melanoma\r\n\r\n          -  Toxoplasmosis scar in study eye or scar related to previous viral retinitis\r\n\r\n          -  Previous viral retinitis\r\n\r\n          -  Current viral diseases of the cornea and conjunctiva including epithelial herpes\r\n             simplex keratitis (dendritic keratitis), vaccinia, and varicella, mycobacterial\r\n             infections of the eye or fungal diseases of ocular structures\r\n\r\n          -  Media opacity precluding evaluation of retina and vitreous\r\n\r\n          -  Peripheral retinal detachment in area of insertion\r\n\r\n          -  Diagnosis of any form of glaucoma or ocular hypertension in study eye at Screening,\r\n             unless study eye has been previously treated with an incisional surgery procedure that\r\n             has resulted in stable Intraocular pressure (IOP) in the normal range (10-21 mmHg)\r\n\r\n          -  IOP > 21 mmHg or concurrent therapy at Screening with any IOP-lowering pharmacologic\r\n             agent in the study eye\r\n\r\n          -  Chronic hypotony (< 6 mmHg)\r\n\r\n          -  Ocular surgery on the study eye within 3 months prior to study Day 1\r\n\r\n          -  Capsulotomy in study eye within 30 days prior to study Day 1\r\n\r\n          -  Prior intravitreal treatment of study eye with Retisert within 36 months prior to\r\n             study Day 1\r\n\r\n          -  Prior intravitreal treatment of study eye with Ozurdex within 6 months prior to study\r\n             Day 1\r\n\r\n          -  Prior intravitreal treatment of study eye with Triesence or Trivaris within 3 months\r\n             prior to study Day 1\r\n\r\n          -  Prior peri-ocular or subtenon steroid treatment of study eye within 3 months prior to\r\n             study Day 1\r\n\r\n          -  Subjects requiring chronic systemic or inhaled corticosteroid therapy (>15mg\r\n             prednisone daily) or chronic systemic immunosuppressive therapy\r\n\r\n          -  Excluding certain skin cancers (specifically, basal cell carcinoma and squamous cell\r\n             carcinoma), any malignancy receiving treatment, or in remission less than 5 years\r\n             prior to study Day 1\r\n\r\n          -  Subjects who have tested positive for human immune deficiency virus (HIV),\r\n             tuberculosis or syphilis\r\n\r\n          -  Systemic infection within 30 days prior to study Day 1\r\n\r\n          -  Any severe acute or chronic medical or psychiatric condition that could increase the\r\n             risk associated with study participation or could interfere with the interpretation of\r\n             study results and, in the judgment of the investigator, could make the subject\r\n             inappropriate for entry into this study\r\n\r\n          -  Any other systemic or ocular condition which, in the judgment of the investigator,\r\n             could make the subject inappropriate for entry into this study\r\n\r\n          -  Treatment with an investigational drug or device within 30 days prior to study Day 1\r\n\r\n          -  Pregnant or nursing females; females of childbearing potential who are unwilling or\r\n             unable to use an acceptable method of contraception as outlined in this protocol from\r\n             at least 14 days prior to study Day 1 until the Month 12 Visit\r\n\r\n          -  Subjects unlikely to comply with the study protocol or who are likely to be lost to\r\n             follow-up within three years\r\n      ","sponsor":"EyePoint Pharmaceuticals, Inc.","sponsor_type":"Industry","conditions":"Posterior Uveitis|Intermediate Uveitis|Panuveitis","interventions":[{"intervention_type":"Drug","name":"Drug: Sham Injection","description":"Placebo"},{"intervention_type":"Drug","name":"Drug: FAI Insert","description":"Fluocinolone Acetonide"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants With Recurrence of Uveitis in Study Eye Within 6 Months","time_frame":"6 Months","description":"Proportion of Subjects with Recurrence of Uveitis in the Study Eye within 6 Months Including Reason for Imputed Recurrence (ITT Population)"},{"outcome_type":"secondary","measure":"Number of Participants With Recurrence of Uveitis in Study Eye Within 36 Months","time_frame":"36 Months","description":"Proportion of Subjects with Recurrence of Uveitis in the Study Eye at 36 Months Including Reason for Imputed Recurrence (ITT Population)"}]}
{"nct_id":"NCT02654613","start_date":"2015-06-01","phase":"N/A","enrollment":8000,"brief_title":"Scaling up TB and HIV Treatment Integration","official_title":"Addressing Challenges in Scaling up TB and HIV Treatment Integration in Public Health Settings in South Africa","primary_completion_date":"2020-12-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-12-30","last_update":"2021-02-01","description":"This study addresses the highest ranking health research priority in South Africa, which is, to develop and test optimal models of HIV-TB service delivery that will enhance retention, adherence and coverage of HIV-TB co-infected patients. HIV and TB are highest in sub-Saharan Africa, a region with limited health budgets, infrastructure, human resources, and suboptimal TB infection control practices. There is compelling clinical evidence suggesting that integrating HIV and TB services saves lives and presents an effective and efficient use of resources directed at optimizing health outcomes. Quality improvement (QI) methods are increasingly being used to systematically test and incorporate local ideas into strategies for reliable implementation and scale up. This trial is designed to test a practical, implementable and affordable strategy aimed at improving HIV-TB service integration to reduce TB and HIV associated deaths. This is a cluster randomized controlled trial, which evaluates and tests the effectiveness of implementing a QI model to integrate HIV-TB service delivery in primary health care clinics, on reducing morbidity and mortality in TB-HIV co-infected patients. This study will be conducted in 2 districts, Ugu and uThungulu, in KwaZulu-Natal, South Africa. The model of integrated care delivery for TB and HIV using the QI method offers a systems approach to care delivery to directly enhance treatment outcomes by enabling comprehensive effective care designed around the patients journey from entry to the clinic, through screening treatment initiation, treatment completion, and retention in care that is directed at the goals of cure for TB, effective sustainable HIV viral suppression and reduced HIV associated TB mortality as the main health impact. The scalability of the model, once proven effective, is the critical element that makes it increase population coverage of quality diagnosis and treatment of HIV-TB co-infection. QI methods promote front line staff engagement in identification and rapid testing of local implementation solutions to gaps in performance of processes of care along the steps of the patient journey. Gaps in care are identified through continuous feedback on a core set of indicators collected monthly as routine collection of data.","other_id":"CAP013","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"None (Open Label)","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  South African Department of Health Primary Health Care Clinics\r\n\r\n          -  ART site\r\n\r\n          -  Supported by BroadReach Healthcare\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Mobile clinics\r\n\r\n          -  Clinics that do not offer ART\r\n\r\n          -  Clinics with only 1 nurse\r\n\r\n          -  Hospitals and Gateway clinics\r\n      ","sponsor":"Centre for the AIDS Programme of Research in South Africa","sponsor_type":"Other","conditions":"HIV|Tuberculosis","interventions":[{"intervention_type":"Other","name":"Other: Quality Improvement Model of Care","description":"QI addresses the \"how\" of program implementation. Technically, QI improves process performance by developing a common simplified view of the components and linkages of integrated care, real-time data feed-back to track system performance, understanding the psychology of system change, and crucially, the iterative testing and incorporation of ideas for performance improvement from the front-line practitioners, managers, and customers in the local context."}],"outcomes":[{"outcome_type":"primary","measure":"Mortality","time_frame":"12 months","description":"Mortality rate in TB-HIV co-infected patients"},{"outcome_type":"secondary","measure":"HIV testing rates","time_frame":"12 months","description":"HIV testing rates in TB patients"},{"outcome_type":"secondary","measure":"Intensified Case Finding for TB","time_frame":"12 Months","description":"TB Screening in HIV infected patients"},{"outcome_type":"secondary","measure":"Cotrimoxazole for HIV-TB patients","time_frame":"12 months","description":"Initiating Cotrimoxazole in HIV-TB patients"},{"outcome_type":"secondary","measure":"Retention in HIV-TB patients","time_frame":"12 months","description":"Enhanced retention in care strategies including the use of community care workers for retention and for community based management of selected patients"},{"outcome_type":"secondary","measure":"ART initiation in HIV-TB co-infected patients","time_frame":"12 months","description":"Initiating ART in co-infected patients irrespective of CD4 count"},{"outcome_type":"secondary","measure":"Integrated Data Management System","time_frame":"12 months","description":"1 data management system for co-infected patients , including 1 file , 1 appointment and 1 health care worker addressing both HIV and TB care and treatment"},{"outcome_type":"secondary","measure":"HIV and TB Adherence Strategy","time_frame":"12 months","description":"• Enhanced ART and TB treatment adherence strategies including the use of community care workers for adherence support and for community based management of selected patients"}]}
{"nct_id":"NCT02869321","start_date":"2015-05-31","phase":"Phase 4","enrollment":20,"brief_title":"Analgesic Efficacy of Transmucosal Fentanyl for Breakthrough Pain Caused by Interventional Gastrostomy","official_title":"Evaluation of Analgesic Efficacy of Transmucosal Fentanyl for Breakthrough Pain Caused by Interventional Gastrostomy","primary_completion_date":"2018-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-05-31","last_update":"2019-05-13","description":"Patients with Head & Neck Squamous Cell Carcinoma often need a gastrostomy. It can be performed with a radiological approach. This procedure is usually not performed under general anesthesia, but local anesthesia is not sufficient to counteract pain due to gastric insufflation and incision of the abdominal wall. Standard analgesic treatments are usually not well-fitted due to onset of action or route of administration. An alternative solution could be fentanyl nasal spray, a treatment with a fast onset of action and with easy use allowing repetition if needed, during the procedure. The purpose of this study is to compare analgesic efficacy of nasal instillation of PECFENT to usually administered morphinic analgesic treatment with fast onset of action (ORAMORPH), in radiologic percutaneous gastrostomy tube placement: - during the procedure - following the procedure (measured by Visual Analog Scale (VAS) for Pain at 15 min, 30 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 12 hours after procedure). Secondary purposes are to compare easiness of 2 treatments and their adverse effects.","other_id":"2014-003352-32","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patient care for cancer of the upper aerodigestive tract (except sinonasal)\r\n\r\n          -  > 18, all weights, all sexes\r\n\r\n          -  Under balanced background opioid treatment since longer than 7 days (VAS < 5)\r\n\r\n          -  Needing a radiologic gastrostomy under local anesthesia\r\n\r\n          -  Informed consent\r\n\r\n          -  Affiliation to social security plan\r\n\r\n          -  Preliminary medical examination\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Non balanced morphinic treatment : modification of analgesic treatment during 7\r\n             previous days\r\n\r\n          -  Radiotherapy of nasal fossae/sinus\r\n\r\n          -  Technical impossibility or contraindication to PECFENT, ORAMORPH and associated\r\n             drugs\r\n\r\n          -  Impossibility of pain evaluation by patient\r\n\r\n          -  Belonging to protected class: pregnant or breastfeeding woman, person deprived of\r\n             liberty for judiciary or administrative decision, under-18, person under legal\r\n             protection or incapable of giving consent, person in life-and-death emergency\r\n             incapable of giving a preliminary consent\r\n      ","sponsor":"Central Hospital, Nancy, France","sponsor_type":"Other","conditions":"Gastrostomy|Breakthrough Pain|Upper Aerodigestive Tract Neoplasms","interventions":[{"intervention_type":"Drug","name":"Drug: Fentanyl"},{"intervention_type":"Drug","name":"Drug: Morphine Sulfate"},{"intervention_type":"Drug","name":"Drug: Fentanyl placebo"},{"intervention_type":"Drug","name":"Drug: Morphine Sulfate placebo"},{"intervention_type":"Procedure","name":"Procedure: Gastrostomy"}],"outcomes":[{"outcome_type":"primary","measure":"Intensity of breakthrough pain during the gastrostomy","time_frame":"during gastrostomy","description":"Pain measured by VAS"},{"outcome_type":"primary","measure":"Intensity of pain following the gastrostomy","time_frame":"15 min after gastrostomy","description":"Pain measured by VAS"},{"outcome_type":"primary","measure":"Intensity of pain following the gastrostomy","time_frame":"30 min after gastrostomy","description":"Pain measured by VAS"},{"outcome_type":"primary","measure":"Intensity of pain following the gastrostomy","time_frame":"1 hour after gastrostomy","description":"Pain measured by VAS"},{"outcome_type":"primary","measure":"Intensity of pain following the gastrostomy","time_frame":"2 hours after gastrostomy","description":"Pain measured by VAS"},{"outcome_type":"primary","measure":"Intensity of pain following the gastrostomy","time_frame":"3 hours after gastrostomy","description":"Pain measured by VAS"},{"outcome_type":"primary","measure":"Intensity of pain following the gastrostomy","time_frame":"4 hours after gastrostomy","description":"Pain measured by VAS"},{"outcome_type":"primary","measure":"Intensity of pain following the gastrostomy","time_frame":"6 hours after gastrostomy","description":"Pain measured by VAS"},{"outcome_type":"primary","measure":"Intensity of pain following the gastrostomy","time_frame":"12 hours after gastrostomy","description":"Pain measured by VAS"},{"outcome_type":"primary","measure":"Necessity of a second analgesic treatment after gastrostomy","time_frame":"up to 12 hours from gastrostomy","description":"in case of Pain VAS >4"},{"outcome_type":"secondary","measure":"Evaluation of satisfaction of patient with analgesic efficacy","time_frame":"up to 1 day from gastrostomy","description":"Questionnaire"},{"outcome_type":"secondary","measure":"Evaluation of satisfaction of staff with analgesic efficacy and easiness to use of treatments","time_frame":"up to 1 day from gastrostomy","description":"Questionnaire"},{"outcome_type":"secondary","measure":"Compliance of times of administration of treatments with the procedure","time_frame":"day 0"},{"outcome_type":"secondary","measure":"Comparison of adverse effects of administered drugs","time_frame":"up to 24 hours post gastrostomy"}]}
{"nct_id":"NCT02388542","start_date":"2015-05-31","phase":"N/A","enrollment":334,"brief_title":"Effect of Peer-mentor Mediated Interventions on Cardiovascular Risk Factors at Worksites","official_title":"Policy and Peer Mentor Intervention Programs on Cardiovascular Disease at Small to Medium Sized Worksites in 3 South Asian Countries - a Pilot Study for a Definitive Large International Cluster Randomized Trial","primary_completion_date":"2017-10-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2017-12-31","last_update":"2017-09-14","description":"The investigators propose conducting a pilot study to identify 6 worksites (2 India, 2 Sri Lanka, 2 Bangladesh) explore barriers to optimum cardiovascular disease(CVD) care at these worksites, quantify risk factor level in worksite populations and identify and train peer mentors to deliver an educational intervention to improve life style and enhance medication adherence among those at moderate to high risk of cardiovascular disease (CVD).","other_id":"PROGRESS-IND-1022015","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":35,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  All criteria must be met to be eligible\r\n\r\n               1. Employees (Men & Women) above the age of 35 years.\r\n\r\n               2. permanent employees with at least 6 months for retirement.\r\n\r\n               3. Willing to provide Informed Consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subject ineligible if even one criterion is met\r\n\r\n               1. Pregnant or intent to get pregnant in one year.\r\n\r\n               2. Inability to attend follow up visits.\r\n\r\n               3. Any active malignancy or known malignancy on treatment.\r\n\r\n               4. Will relocate during the study period.\r\n\r\n               5. Unwilling or unable to comply with study procedures.\r\n      ","sponsor":"St. John's Research Institute","sponsor_type":"Other","conditions":"Cardiovascular Disease","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Educational Intervention","description":"Employees above the age of 35 years will be risk stratified into moderate or high risk of developing cardiovascular disease using a simple non-lab based risk scoring system, they will be invited to participate in the pilot intervention study. This is a single arm before-after study.subject education will focus on life style medication and adherence to medication (if applicable).importantly the peer mentor will try to identify barriers to adopting a healthy lifestyle(tobacco, physical acitivity, diet, alcohol and strees) and adherence to cardiovascular disease prevention medication. peer mentors will be trained to interpret blood glucose and lipids, recognize abnormal valves, provide lifestyle counseling and refer to treating physician when appropriate."}],"outcomes":[{"outcome_type":"primary","measure":"Change in knowledge attitudes & practices related to Cardiovascular risk factors. (questionnaire)","time_frame":"1 Month","description":"A knowledge, attitudes & practices questionnaire will be administered to participants"},{"outcome_type":"primary","measure":"Identification of barriers and facilitators for an optimal Cardiovascular Health environment. (In depth interviews and focus groups discussions with random sample of participants)","time_frame":"3 Months","description":"qualitative analysis - In depth interviews and focus groups discussions with random sample of participants"},{"outcome_type":"primary","measure":"Estimate the Cardiovascular risk factor burden (validated non lab based Cardiovascular risk score)","time_frame":"3 Months","description":"validated non lab based Cardiovascular risk score will be used (developed from NHANES data and validated against Framingham score"}]}
{"nct_id":"NCT02107118","start_date":"2015-05-31","phase":"Phase 1","enrollment":0,"brief_title":"Stem Cells for the Improvement of Erectile and Cardiac Function in Aging Men","official_title":"H-34570: PHASE I Study: The Use of Autologous Adipose Tissue-Derived Mesenchymal Stem Cell (AdMSC) for the Improvement of Erectile and Cardiac Function in Aging Men","primary_completion_date":"2020-03-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2022-02-28","last_update":"2015-05-25","description":"Men who present with erectile dysfunction as defined as an IIEF (International Index of Erectile Function) score less than 21 will be evaluated for risk factors for cardiovascular disease (CVD). This is a single-blind study. Subjects will be randomized in a 2:1 fashion for treatment (ARM 1) versus placebo (ARM 2). Adipose tissue (fat) will be harvested from all patients and stem cells will be cultured. For those patients in the placebo arm the stem cells will be frozen for later use after one year when the patients cross over into the treatment arm.","other_id":"H-34570 No.11-13-40-07","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"Male","minimum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Men 40 years of age or older\r\n\r\n          -  Men with erectile dysfunction as defined by IIEF score less than 21\r\n\r\n          -  Men with endothelial dysfunction as defined as an RHI score less than 2\r\n\r\n          -  Men with normal testosterone levels (300 ng/dl)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Men under the age of 40\r\n\r\n          -  Men with normal erectile function\r\n\r\n          -  Men with normal endothelial function\r\n\r\n          -  Men with low testosterone levels (less than 300ng/dl)\r\n      ","sponsor":"Baylor College of Medicine","sponsor_type":"Other","conditions":"Erectile Dysfunction|Cardiac Disease","interventions":[{"intervention_type":"Other","name":"Other: ARM 2: Placebo","description":"Adipose tissue will be harvested from all patients as previously described and stem cells will be cultured. For those subjects in the placebo arm, the stem cells will be frozen for later use after one year when the patients cross over into the treatment arm."},{"intervention_type":"Biological","name":"Biological: ARM 1: AdMSC: adipose stem cells","description":"Adipose tissue will be harvested from all patients as previously described and stem cells will be cultured. Cells are returned to the study doctor for installation into the subject every 2 weeks for 3 months."}],"outcomes":[{"outcome_type":"primary","measure":"Improvements in IIEF scores of greater than 2","time_frame":"12 months","description":"The analysis will allow us to assess if stem cells can improve IIEF scores. The IIEF will be given at the 3, 6, 9, and 12 month visits."},{"outcome_type":"secondary","measure":"Improvements in RHI (reactive hyperemic index) scores of greater than 0.3","time_frame":"12 months","description":"The analysis will allow us to assess if stem cells can improve endothelial function. The RHI scores will be reviewed at the 3, 6, 9, and 12 month visits."},{"outcome_type":"other","measure":"Improvements in penile duplex","time_frame":"12 months","description":"The analysis will allow us to assess if stem cells can improve penile duplex. The penile duplex will be given at the 3 and 12 month visits."},{"outcome_type":"other","measure":"Improvements in echocardiogram","time_frame":"12 months","description":"The analysis will allow us to assess if stem cells can improvement results of the echocardiogram. The echocardiogram will be done at the 3 and 12 month visits."}]}
{"nct_id":"NCT02456727","start_date":"2015-05-31","phase":"N/A","enrollment":779,"brief_title":"Acupuncture Approaches for Chronic Pain","official_title":"Acupuncture Approaches to Decrease Disparities in Outcomes of Pain Treatment - A Two Arm Comparative Effectiveness Trial","primary_completion_date":"2018-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-03-31","last_update":"2020-09-18","description":"Chronic pain is a major public health problem that places many burdens on individuals, including impairment of physical and psychological functioning, lost productivity, and side effects of medications used to treat pain. There is also substantial evidence that minority populations differ both in prevalence and outcomes of chronic pain; access to care is a key component in these differences. Strong evidence now supports the use of acupuncture in the treatment of chronic pain conditions, including when provided in the primary care setting to participants from ethnically diverse, medically underserved populations. Acupuncture is slowly being integrated into pain management in many conventional health care settings, but cost and reimbursement for this service remain obstacles to offering acupuncture, especially in primary care and safety net settings. Because group acupuncture can be offered at much lower cost, demonstrating that individual and group delivery are equally effective could reduce barriers to use of this effective pain management approach. The primary aim of this study will be to evaluate whether acupuncture delivered in the group setting for participants with chronic pain is equal to acupuncture delivered in the individual setting. A secondary objective will be to use qualitative analysis to understand and describe the participants' experience of both acupuncture approaches, and to utilize this data to inform intervention delivery and dissemination, to better incorporate the participants' perspective.","other_id":"2014-4192","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":21,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Referred by a primary care provider from one of our participating primary care health\r\n             centers\r\n\r\n          -  Provider-documented diagnosis of osteoarthritis (any joint), neck pain, OR back pain\r\n\r\n          -  Self-reported pain score of 4 for at least 3 months prior to program entry\r\n\r\n          -  Able to provide consent for treatment and data collection in either English or Spanish\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  < 21 years of age\r\n\r\n          -  Chronic pain not documented OR self reported pain of 4 for less than 3 months.\r\n\r\n          -  Currently taking oral or injectable anticoagulants.\r\n\r\n          -  Lack of contact information OR unavailable for duration of entire treatment period (24\r\n             weeks)\r\n\r\n          -  Inability to consent to treatment and data collection.\r\n\r\n          -  Active psychosis\r\n\r\n          -  Active substance abuse\r\n      ","sponsor":"Albert Einstein College of Medicine","sponsor_type":"Other","conditions":"Chronic Pain|Osteoarthritis|Neck Pain|Back Pain","interventions":[{"intervention_type":"Procedure","name":"Procedure: Group/Community Acupuncture","description":"Acupuncture treatment in a group setting."},{"intervention_type":"Procedure","name":"Procedure: Individual Acupuncture","description":"Acupuncture treatment in an individual setting."}],"outcomes":[{"outcome_type":"primary","measure":"Pain Interference as Measured by the Brief Pain Inventory (BPI) (Intent to Treat Model)","time_frame":"Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)","description":"The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the primary measure of how much the participants' pain interferes with daily life. Pain interference is calculated using 7 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 7, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. Investigators measured improvement in BPI pain interference from baseline to week 24 (12 weeks after treatment window). The definition of intent to treat is all participants who were randomized into treatment. Statistical analysis only performed on baseline and week 12 (end of treatment) data."},{"outcome_type":"primary","measure":"Pain Interference as Measured by the Brief Pain Inventory (BPI) (Per Protocol Model)","time_frame":"Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window))","description":"The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the primary measure of how much your pain interferes with your life. Pain interference is calculated using 7 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 7, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. We measured improvement in BPI pain interference from baseline to week 24 (12 weeks after treatment window). The definition of Per Protocol is all participants who were randomized and who attended >=8 sessions of acupuncture. Statistical analysis only performed on baseline and week 12 (end of treatment) data."},{"outcome_type":"primary","measure":"Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 12 (Intent to Treat Model)","time_frame":"Baseline, Week 12 (End of Treatment Window)","description":"The Brief Pain Inventory (BPI) short form, is a participant reported questionnaire that serves as the primary measure of how much your pain interferes with your life. It is a quality of life measure. Pain interference is calculated using 7 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 7, therefore final scores can range from 0 - 10. Having a higher score indicates your pain interference is worse. Respondent data is used for this analysis which shows whether participants experienced improvement in their pain interference from baseline to the end of treatment window (week 12). 30% improvement is a decrease of >=2 points on the BPI from baseline to the end of treatment window (week 12). A 30% decrease is considered a clinically significant improvement in pain. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 12 questionnaire were analyzed."},{"outcome_type":"primary","measure":"Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 12 (Per Protocol Model)","time_frame":"Baseline, Week 12 (End of Treatment)","description":"The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the primary measure of how much your pain interferes with your life. It is a quality of life measure. Pain interference is calculated using 7 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 7, therefore final scores can range from 0 - 10. Having a higher score indicates your pain interference is worse. Respondent data is used for this analysis which shows whether participants experienced improvement in pain interference from baseline to the end of treatment window (week 12). 30% improvement is a decrease of >=2 points on the BPI from baseline to the end of treatment window (week 12). A 30% decrease is considered a clinically significant improvement in pain. Per Protocol is all participants who were randomized and who attended >=8 sessions of acupuncture. Only participants who completed a week 12 questionnaire were analyzed."},{"outcome_type":"primary","measure":"Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 24 (Intent to Treat Model)","time_frame":"Baseline, Week 24 (12 weeks after treatment window)","description":"The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the primary measure of how much your pain interferes with your life. It is a quality of life measure. Pain interference is calculated using 7 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 7, therefore final scores can range from 0 - 10. Having a higher score indicates your pain interference is worse. Respondent data is used for this analysis which shows whether participants experienced improvement in pain interference from baseline to week 24 (12 weeks after treatment window). 30% improvement is a decrease of >=2 points on the BPI from baseline to week 24 (12 weeks after treatment window). The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 24 questionnaire were included in the analysis."},{"outcome_type":"primary","measure":"Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 24 (Per Protocol Model)","time_frame":"Baseline, Week 24 (12 weeks after treatment window)","description":"The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the primary measure of how much your pain interferes with your life. It is a quality of life measure. Pain interference is calculated using 7 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 7, therefore final scores can range from 0 - 10. Having a higher score indicates your pain interference is worse. Respondent data is used for this analysis which shows whether participants experienced improvement in pain interference from baseline to week 24 (12 weeks after treatment). 30% improvement is a decrease of >=2 points on the BPI from baseline to week 24 (12 weeks after treatment). The definition of Per Protocol is all participants who have been randomized and who attended >=8 sessions of acupuncture. Only patients who completed a week 24 questionnaire were included in the analysis."},{"outcome_type":"secondary","measure":"Pain Severity as Measured by the Brief Pain Inventory (BPI) (Intent to Treat Model)","time_frame":"Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)","description":"The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the measure of how severe your pain is. Pain severity is calculated using 4 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and then divided by 4, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. We measured improvement in BPI pain severity from baseline to week 24 (12 weeks after treatment window). The definition of intent to treat is anyone who intended to receive treatment; in our case, it is all participants who were randomized into treatment. Statistical analysis only performed on baseline and week 12 (end of treatment) data."},{"outcome_type":"secondary","measure":"Pain Severity as Measured by the Brief Pain Inventory (BPI) (Per Protocol Model)","time_frame":"Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)","description":"The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the measure of how severe your pain is. Pain severity is calculated using 4 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 4, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. We measured improvement in BPI pain severity from baseline to week 24 (12 weeks after treatment window). The definition of Per Protocol is all participants who were randomized and who attended >=8 sessions of acupuncture. Statistical analysis only performed on baseline and week 12 (end of treatment) data."},{"outcome_type":"secondary","measure":"Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 12 (Intent to Treat Model)","time_frame":"Baseline, Week 12 (End of Treatment Window)","description":"The Brief Pain Inventory (BPI) short form, is a participant reported questionnaire that serves as the measure of how severe your pain is. Pain severity is calculated using 4 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 4, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. Respondent data is used for this analysis which shows whether participants experienced an improvement in their pain severity from baseline to the end of treatment window (week 12). 30% improvement is a decrease of >=2 points on the BPI from baseline to the end of treatment window (week 12). A 30% decrease in pain severity is considered a clinically significant improvement in pain. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 12 questionnaire were analyzed."},{"outcome_type":"secondary","measure":"Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 12 (Per Protocol Model)","time_frame":"Baseline, Week 12 (End of Treatment Window)","description":"The Brief Pain Inventory (BPI) short form, is a participant reported questionnaire that serves as the measure of how severe your pain is. Pain severity is calculated using 4 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 4, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. Respondent data is used for this analysis which shows whether participants experienced an improvement in their pain severity from baseline to the end of treatment window (week 12). 30% improvement is a decrease of >=2 points on the BPI from baseline to the end of treatment window (week 12). A 30% decrease in pain severity is considered a clinically significant improvement in pain. The definition of Per Protocol is all participants who were randomized and who attended >=8 sessions of acupuncture. Only participants who completed a week 12 questionnaire were analyzed."},{"outcome_type":"secondary","measure":"Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 24 (Intent to Treat Model)","time_frame":"Baseline, Week 24 (12 Weeks After Treatment Window)","description":"The Brief Pain Inventory (BPI) short form, is a participant reported questionnaire that serves as the measure of how severe your pain is. Pain severity is calculated using 4 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 4, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. Respondent data is used for this analysis which shows whether participants experienced an improvement in their pain severity from baseline to week 24 (12 weeks after treatment window). 30% improvement is a decrease of >=2 points on the BPI from baseline to week 24 (12 weeks after treatment window). A 30% decrease in pain severity is considered a clinically significant improvement in pain. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 24 questionnaire were analyzed."},{"outcome_type":"secondary","measure":"Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 24 (Per Protocol Model)","time_frame":"Baseline, Week 24 (12 Weeks After Treatment Window)","description":"The Brief Pain Inventory (BPI) short form, is a participant reported questionnaire that serves as the measure of how severe your pain is. Pain severity is calculated using 4 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 4, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. Respondent data is used for this analysis which shows whether participants experienced an improvement in their pain severity from baseline to week 24 (12 weeks after treatment window). 30% improvement is a decrease of >=2 points on the BPI from baseline to week 24 (12 weeks after treatment window). A 30% decrease in pain severity is considered a clinically significant improvement in pain. The definition of Per Protocol is all participants who have been randomized and who attended >=8 sessions of acupuncture. Only patients who completed a week 24 questionnaire were analyzed."},{"outcome_type":"secondary","measure":"Patient Global Impression of Change (PGIC) at Week 12 and Week 24 (Intent to Treat Model)","time_frame":"Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)","description":"The Patient Global Impression of Change (PGIC) is a self-reported questionnaire that indicates if a participant has perceived a change in their condition after having some sort of treatment. In this case, we evaluated whether the participants experienced a positive change after receiving treatment, a decrease in their pain, from baseline (before receiving treatment) to week 24 (12 weeks after treatment window). The PGIC is scored from 0 (much better) to 10 (much worse). A higher score indicates that a participant has felt worse since starting treatment. The definition of intent to treat is all participants who were randomized into treatment. Statistical analysis only performed on baseline and week 12 (end of treatment) data."},{"outcome_type":"secondary","measure":"Patient Global Impression of Change (PGIC) at Week 12 and Week 24 (Per Protocol Model)","time_frame":"Week 12 (end of treatment window), and week 24 (12 weeks after treatment window)","description":"The Patient Global Impression of Change (PGIC) is a self-reported questionnaire that indicates if a participant has perceived a change in their condition after having some sort of treatment. In this case, we evaluated whether the participants experienced a positive change after receiving treatment, a decrease in their pain, from baseline (before receiving treatment) to week 24 (12 weeks after treatment window). The PGIC is scored from 0 (much better) to 10 (much worse). A higher score indicates that a participant has felt worse since starting treatment. The definition of Per Protocol is all participants who were randomized and who attended >=8 sessions of acupuncture. Statistical analysis only performed on baseline and week 12 (end of treatment) data."},{"outcome_type":"secondary","measure":"Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 12 (Intent to Treat Model)","time_frame":"Week 12 (End of Treatment Window)","description":"The Patient Global Impression of Change (PGIC) is a self-reported questionnaire that indicates if a patient has perceived a change in their condition after having some sort of treatment. Respondent data is used for this analysis which shows whether participants experienced improvement. Respondent data for the PGIC is scored using one question that ranges from 0 (no change or the condition got worse) to 7 (a great deal better). Improvement is defined as a score of >=6 points on the PGIC at week 12 (end of treatment window) as reported by the participants. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 12 questionnaire were included in the analysis."},{"outcome_type":"secondary","measure":"Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 12 (Per Protocol Model)","time_frame":"Week 12 (End of Treatment Window)","description":"The Patient Global Impression of Change (PGIC) is a self-reported questionnaire that indicates if a patient has perceived a change in their condition after having some sort of treatment. Respondent data is used for this analysis which shows whether participants experienced improvement. Respondent data for the PGIC is scored using one question that ranges from 0 (no change or the condition got worse) to 7 (a great deal better). Improvement is defined as a score of >=6 points on the PGIC at week 12 (end of treatment window) as reported by the participants. The definition of Per Protocol is all participants who were randomized and who attended >=8 sessions of acupuncture. Only participants who completed a week 12 questionnaire were included in the analysis."},{"outcome_type":"secondary","measure":"Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 24 (Intent to Treat Model)","time_frame":"Week 24 (12 Weeks After Treatment Window","description":"The Patient Global Impression of Change (PGIC) is a self-reported questionnaire that indicates if a patient has perceived a change in their condition after having some sort of treatment. Respondent data is used for this analysis which shows whether participants experienced improvement. Respondent data for the PGIC is scored using one question that ranges from 0 (no change or the condition got worse) to 7 (a great deal better). Improvement is defined as a score of >=6 points on the PGIC at week 24 (12 weeks after treatment window) as reported by the participants. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 24 questionnaire were included in the analysis."},{"outcome_type":"secondary","measure":"Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 24 (Per Protocol Model)","time_frame":"Week 24 (12 Week After Treatment Window)","description":"The Patient Global Impression of Change (PGIC) is a self-reported questionnaire that indicates if a patient has perceived a change in their condition after having some sort of treatment. Respondent data is used for this analysis which shows whether participants experienced improvement. Respondent data for the PGIC is scored using one question that ranges from 0 (no change or the condition got worse) to 7 (a great deal better). Improvement is defined as a score of >=6 points on the PGIC at week 24 (12 weeks after treatment window) as reported by the participants. The definition of Per Protocol is all participants who were randomized and who attended >=8 sessions of acupuncture. Only participants who completed a week 24 questionnaire were included in the analysis."},{"outcome_type":"secondary","measure":"Participant Physical Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Intent to Treat Model)","time_frame":"Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window))","description":"The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. It consists of 10 questions, for physical health only 4 questions are used, scoring for physical health can range from 4-20 (Raw score), the higher the score the better the outcome. The raw scores are changed into T-scores that range from 16.2-67.7. For this measure, we collected physical health scores from baseline to week 24 (12 weeks after treatment window). The definition of intent to treat is all participants who were randomized into treatment. Statistical analysis only performed on baseline and week 12 (end of treatment) data."},{"outcome_type":"secondary","measure":"Participant Physical Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Per Protocol Model)","time_frame":"Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)","description":"The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. It consists of 10 questions, for physical health only 4 questions are used, scoring for physical health can range from 4-20 (Raw score), the higher the score the better the outcome. The raw scores are changed into T-scores that range from 16.2-67.7. For this measure, we collected physical health scores from baseline to week 24 (12 weeks after treatment window). The definition of Per Protocol is all participants who were randomized and who attended >=8 sessions of acupuncture. Statistical analysis only performed on baseline and week 12 (end of treatment) data.."},{"outcome_type":"secondary","measure":"Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Intent to Treat Model)","time_frame":"Baseline, Week 12 (End of treatment window)","description":"The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The physical health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T score which can range from 16.2 to 67.7. The higher the score the better your physical health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 12 (end of treatment window), a >=2-point increase is considered a 30% improvement. The definition of intent to treat is all participants who have been randomized into treatment. Only patients who completed a week 12 questionnaire were included in the analysis."},{"outcome_type":"secondary","measure":"Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Per Protocol Model)","time_frame":"Baseline, Week 12 (End of Treatment Window)","description":"The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The physical health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T score which can range from 16.2 to 67.7. The higher the score the better your physical health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 12 (end of treatment window), a >=2-point increase is considered a 30% improvement. The definition of Per Protocol is all participants who have been randomized and who attended >=8 sessions of acupuncture. Only patients who completed a week 12 questionnaire were included in the analysis."},{"outcome_type":"secondary","measure":"Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Intent to Treat Model)","time_frame":"Baseline, Week 24 (12 Weeks After Treatment Window)","description":"The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The physical health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T score which can range from 16.2 to 67.7. The higher the score the better your physical health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 24 (12 weeks after treatment window), a >=2-point increase is considered a 30% improvement. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 24 questionnaire were included in the analysis."},{"outcome_type":"secondary","measure":"Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Per Protocol Model)","time_frame":"Baseline, Week 24 (12 Weeks After Treatment Window)","description":"The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The physical health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T score which can range from 16.2 to 67.7. The higher the score the better your physical health is. Improvement is categorized as a >= 2-point increase in the PROMIS-10 T-score from baseline to week 24 (12 weeks after treatment window). The definition of Per Protocol is all participants who were randomized and who attended >=8 sessions of acupuncture. Only participants who completed a week 24 questionnaire were included in the analysis."},{"outcome_type":"secondary","measure":"Participant Mental Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Intent to Treat Model)","time_frame":"Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)","description":"The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. It consists of 10 questions, for mental health only 4 questions are used, scoring for mental health can range from 4-20 (Raw score), the higher the score the better the outcome. The raw scores are changed into T-scores that range from 21.2-67.6. For this measure, we collected mental health scores from baseline to week 24 (12 weeks after treatment window). The definition of intent to treat is all participants who were randomized into treatment. Statistical analysis only performed on baseline and week 12 (end of treatment) data."},{"outcome_type":"secondary","measure":"Participant Mental Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Per Protocol Model)","time_frame":"Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)","description":"The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. It consists of 10 questions, for mental health only 4 questions are used, scoring for mental health can range from 4-20 (Raw score), the higher the score the better the outcome. The raw scores are changed into T-scores that range from 21.2-67.6. For this measure, we collected mental health scores from baseline to week 24 (12 weeks after treatment window). The definition of Per Protocol is all participants who were randomized and who attended >=8 sessions of acupuncture. Statistical analysis only performed on baseline and week 12 (end of treatment) data."},{"outcome_type":"secondary","measure":"Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Intent to Treat Model)","time_frame":"Baseline, Week 12 (End of Treatment Window)","description":"The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The mental health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T score which can range from 21.2 to 67.6. The higher the score the better your mental health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 12 (end of treatment window), a >=5-point increase is what we used to measure improvement. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 12 questionnaire were included in the analysis."},{"outcome_type":"secondary","measure":"Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Per Protocol Model)","time_frame":"Baseline, Week 12 (End of Treatment Window)","description":"The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The mental health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T score which can range from 21.2 to 67.6. The higher the score the better your mental health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 12 (end of treatment window), a >=5-point increase is what we used to measure improvement. The definition of Per Protocol is all participants who have been randomized and who attended >=8 sessions of acupuncture. Only patients who completed a week 12 questionnaire were included in the analysis."},{"outcome_type":"secondary","measure":"Participants With Opioid Prescription Within a 6 Month Period Around Treatment Window According to Electronic Medical Record (EMR) Data (Intent to Treat Model)","time_frame":"6-Month Period Around Treatment Window (3 months pre- and 3 months post-treatment)","description":"Participants' electronic medical records (EMR) were reviewed to see if they had a prescription for opioids during the 6-month period around their treatment window (3 months pre- and 3 months post-treatment). The definition of intent to treat is all participants who were randomized into treatment. There were 191 total participants that had \"any documented opioid prescriptions in EMR."},{"outcome_type":"secondary","measure":"Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Intent to Treat Model)","time_frame":"Baseline, Week 24 (12 Weeks After Treatment Window)","description":"The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The mental health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T-score which can range from 21.2 to 67.6. The higher the score the better your mental health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 24 (12 weeks after treatment window), a >=5-point increase is what we used to measure improvement. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 24 questionnaire were included in the analysis."},{"outcome_type":"secondary","measure":"Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Per Protocol Model)","time_frame":"Baseline, Week 24 (12 Weeks After Treatment Window)","description":"The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The mental health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T-score which can range from 21.2 to 67.6. The higher the score the better your mental health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 24 (12 weeks after treatment window), a >=5-point increase is what we used to measure improvement. The definition of Per Protocol is all participants who were randomized and who attended >=8 sessions of acupuncture. Only participants who completed a week 24 questionnaire were included in the analysis."},{"outcome_type":"secondary","measure":"Participants Who Reported Use of Prescription Opioids in the Last Week (Intent to Treat Model)","time_frame":"Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)","description":"Participants were asked whether they took any opioid medication within the last week. We compared self-reported prescription opioid use within a week of their baseline and week 12 questionnaires. The definition of intent to treat is all participants who have been randomized into treatment. Only participants who report having an opioid prescription are included in the analysis therefore if the participant did not have an opioid prescription they were excluded from the analysis. Statistical analysis only performed on baseline and week 12 (end of treatment) data."},{"outcome_type":"secondary","measure":"Participants Who Reported Use of Prescription Opioids in the Last Week (Per Protocol Model)","time_frame":"Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)","description":"Participants were asked whether they took any opioid medication within the last week. We compared self-reported prescription opioid use within a week of their baseline and week 12 questionnaires. The definition of Per Protocol is all participants who have been randomized and who attended >=8 sessions of acupuncture. Only participants who report having an opioid prescription are included in the analysis therefore if the participant did not have an opioid prescription they were excluded from the analysis. Statistical analysis only performed on baseline and week 12 (end of treatment) data."},{"outcome_type":"secondary","measure":"Number of Days Participants Reported Using Prescription Opioids in the Last 7 Days (Intent to Treat Model)","time_frame":"Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)","description":"Participants were asked whether they took any opioid medication within the last week. If they did take any opioids in the last week we asked how many days they took their opioid medication. We collected data on the mean number of days participants took prescription opioid medication from baseline to week 24 (12 weeks after treatment window). The definition of intent to treat is all participants who were randomized into treatment. Statistical analysis only performed on baseline and week 12 (end of treatment) data."},{"outcome_type":"secondary","measure":"Number of Days Participants Reported Using Prescription Opioids in the Last 7 Days (Per Protocol Model)","time_frame":"Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)","description":"Participants were asked whether they took any opioid medication within the last week. If they did take any opioids in the last week we asked how many days they took their opioid medication. We collected data on the mean number of days participants took prescription opioid medication from baseline to week 24 (12 weeks after treatment window). The definition of Per Protocol is all participants who were randomized and who attended >=8 sessions of acupuncture. Statistical analysis only performed on baseline and week 12 (end of treatment) data."},{"outcome_type":"secondary","measure":"Change in Participant Opioid Use in Milligrams of Morphine Equivalents (MME) Between 3 Months Pre and 3 Months Post-treatment Using Electronic Medical Record (EMR) Data (Intent to Treat Model)","time_frame":"6-Month Period Around Treatment Window (3 months pre- and 3 months post-treatment)","description":"Milligrams of Morphine Equivalence (MME) is a value assigned to represent how strong an opioid is. It is determined by calculating a dose of morphine equivalent to the prescribed opioid. We compared the MME for participants who had Opioid prescriptions in their electronic medical records (EMR) during the 6 month period around treatment (3 months prior and post-treatment). A smaller MME indicates that the participant was using less medication. The definition of intent to treat is all participants who were randomized into treatment. The analysis is limited to participants who have documented opioid prescriptions in EMR. The change in MME was defined as post treatment minus pre treatment (in milligrams)."},{"outcome_type":"secondary","measure":"Change in Participant Opioid Use in Milligrams of Morphine Equivalents (MME) Between 3 Months Pre and 3 Months Post-treatment Using Electronic Record (EMR) Data (Per Protocol Model)","time_frame":"6-Month Period Around Treatment Window (3 months pre- and 3 months post-treatment)","description":"Milligrams of Morphine Equivalence (MME) is a value assigned to represent how strong an opioid is. It is determined by calculating a dose of morphine equivalent to the prescribed opioid. We compared the MME of participants who had Opioid prescriptions in their electronic medical records (EMR) during the 6 month period around treatment (3 months pre- and 3 months post-treatment). A smaller MME indicates that the participant was using less medication. The definition of Per Protocol is all participants who were randomized and who attended >=8 sessions of acupuncture. The analysis is limited to participants who have documented opioid prescriptions in EMR. The change in MME was defined as post treatment minus pre treatment (in milligrams)."},{"outcome_type":"secondary","measure":"Participants With Opioid Prescription Within a 6 Month Period Around Treatment Window According to Electronic Medical Record (EMR) Data ) (Per Protocol Model)","time_frame":"6-Month Period Around Treatment Window (3 months pre- and 3 months post-treatment)","description":"Participants' electronic medical records (EMR) were reviewed to see if they had a prescription for opioids during the 6-month period around their treatment window (3 months pre- and 3 month post-treatment). The definition of Per Protocol is all participants who were randomized and who attended >=8 sessions of acupuncture."}]}
{"nct_id":"NCT02440230","start_date":"2015-05-31","phase":"Phase 2","enrollment":110,"brief_title":"Safety of OFS Combined With AI Endocrine Therapy in Chinese Premenopausal Breast Cancer Patients","official_title":"Safety of Ovarian Function Suppression(OFS)Combined With Different Aromatase Inhibitors(AIs) Endocrine Therapy in Chinese Premenopausal Breast Cancer PatientsA Randomized, Controlled, Prospective, Observational Study","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-12-31","last_update":"2021-04-09","description":"To compare safety of adjuvant OFS combined with anastrozole versus OFS combined with exemestane in Chinese premenopausal hormonal receptor(HR) positive breast cancer patients.","other_id":"RJBC1503","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Women aged 18 years;\r\n\r\n          2. Histologically confirmed invasive breast cancer by core needle biopsy or\r\n             surgery,hormonal receptor positive, defined as estrogen receptor(ER)/progesterone\r\n             receptor(PR) positive;\r\n\r\n          3. Premenopausal defined as\r\n\r\n               -  who have been menstruating regularly during the 6 months prior to randomization\r\n                  and have not used any form of hormonal contraception or any other hormonal\r\n                  treatments during the 6 months prior to randomization.\r\n\r\n               -  premenopausal status confirmed by an estradiol (E2) in the premenopausal range\r\n                  after chemotherapy related amenorrhea;\r\n\r\n          4. Patients must have received standard local therapy: normalized modified radical\r\n             mastectomy or breast conserving surgery with negative margin and post-surgical\r\n             radiotherapy. Patient should completed adjuvant therapy according to conditions,\r\n             including adjuvant radiotherapy, neoadjuvant or adjuvant chemotherapy;\r\n\r\n          5. Patients who did not receive chemotherapy should be randomized within 24 weeks after\r\n             definitive surgery.Patients who received prior adjuvant and/or neoadjuvant\r\n             chemotherapy should be randomized after completing chemotherapy and within 8 months of\r\n             the final dose of chemotherapy as soon as premenopausal status is confirmed;\r\n\r\n          6. Leukocyte  3*109/L; Platelets  75*109/L; Serum glutamate;\r\n\r\n          7. oxaloacetate(AST/SGOT) or serum glutamic-pyruvic transaminase(ALT/SGPT) <2.5 times of\r\n             upper limit of normal (UNL) range;\r\n\r\n          8. Serum creatinine/blood urea nitrogen(BUN)  upper limit of normal (UNL) range;\r\n\r\n          9. Written informed consent according to the local ethics committee requirements.\r\n\r\n         10. Has Eastern Cooperative Oncology Group(ECOG) Performance Score 0-2;\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Histologically confirmed hormonal receptor negative.\r\n\r\n          2. Post-menopausal.\r\n\r\n          3. Patients with inoperable local advanced breast cancer including inflammatory breast\r\n             cancer or supraclavicular node involvement or with enlarged internal mammary nodes\r\n             (unless pathologically negative).\r\n\r\n          4. Definitive surgery was done over 24 weeks before randomization for patients who did\r\n             not receive chemotherapy.The final dose of chemotherapy was completed over 8 months\r\n             before randomization for patients who received prior adjuvant and/or neoadjuvant\r\n             chemotherapy.\r\n\r\n          5. Pregnant or lactating.\r\n\r\n          6. Patients with previous or concomitant invasive malignancy are not eligible. The\r\n             exceptions are patients with the following (and only the following) malignancies\r\n             (previous or concomitant) who are eligible if adequately treated: basal or squamous\r\n             cell carcinoma of the skin in situ non-breast carcinoma without invasion contra- or\r\n             ipsilateral in situ breast carcinoma non-breast invasive malignancy diagnosed at least\r\n             5 years ago and without recurrence:\r\n\r\n               -  stage I papillary thyroid cancer\r\n\r\n               -  stage Ia carcinoma of the cervix\r\n\r\n               -  stage Ia or b endometrioid endometrial cancer\r\n\r\n               -  borderline or stage I ovarian cancer\r\n\r\n          7. Patients who received endocrine therapy (including neoadjuvant and adjuvant) for more\r\n             than 8 months after their breast cancer diagnosis.\r\n\r\n          8. Patients who were taking tamoxifen or other selective estrogen receptor modulator\r\n             (SERM,e.g. Raloxifene) or hormone replacement therapy (HRT) within one year prior to\r\n             their breast cancer diagnosis.\r\n\r\n          9. Patients who have had a bilateral oophorectomy or ovarian irradiation prior to their\r\n             breast cancer diagnosis.\r\n\r\n         10. With severe hepatic dysfunction, Child-Pugh C.\r\n\r\n         11. With severe cardiac dysfunction, New York Heart Association (NYHA) grading III or\r\n             worse.\r\n\r\n         12. Known severe hypersensitivity to any drugs in this study.\r\n\r\n         13. Participants of other experimental drug clinical trials\r\n      ","sponsor":"Shanghai Jiao Tong University School of Medicine","sponsor_type":"Other","conditions":"Breast Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: OFS + Anastrozole","description":"Ovarian function suppression can be achieved by choice of goserelin at a dose of 3.6 mg administered by means of subcutaneous injection every 28 days,bilateral oophorectomy,or bilateral ovarian irradiation.\r\nPatients will take anastrozole 1mg qd."},{"intervention_type":"Drug","name":"Drug: OFS + Exemestane","description":"Patients will take exemestane 25mg qd. Ovarian function suppression can be achieved by choice of goserelin at a dose of 3.6 mg administered by means of subcutaneous injection every 28 days,bilateral oophorectomy,or bilateral ovarian irradiation."}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of bone or joint pains","time_frame":"participants will be followed at 0,3,6,9,12 months from enrollment.","description":"Bone and joint pains are measured by National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI CTCAE) classification v4.0 every 3 months."},{"outcome_type":"secondary","measure":"peri-menapausal syndrome","time_frame":"KMI score"}]}
{"nct_id":"NCT02861547","start_date":"2015-05-31","enrollment":355,"brief_title":"Development and Validation of a Prognostic Score for Early Death in Head Injury Patients.","official_title":"Development and Validation of a Prognostic Score for Early Death in Head Injury Patients in the Traumatic Brain Injury Intensive Care Unit of Dijon CHU","primary_completion_date":"2017-05-31","study_type":"Observational","rec_status":"Unknown status","last_update":"2016-08-10","description":"Traumatic brain injury (TBI) is a serious condition with high morbidity and mortality. The Glasgow score alone, assessed at the initial phase, is not enough to determine the prognosis. The aim of this study is to define and to evaluate a prognostic score for early death based on clinical and CT-scan findings in an observational retrospective derivation cohort of patients hospitalized for traumatic brain injury. This cohort will allow us to carry out a uni- and then multi-variate analysis so as to create a prognostic score for early death. We will subsequently test this score in a prospective validation cohort.","other_id":"MIREK 2015","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":15,"population":"Patients hospitaliss pour traumatic brain injury","criteria":"\n        Inclusion Criteria:\r\n\r\n        Traumatic brain injury (PMSI code (Programme Mdicalisation des Systmes d'Information) S\r\n        06.70 and S 06.71) Age>14 years Surviving more than 6h after the trauma Hospitalized in the\r\n        traumatic brain injury intensive care unit and managed in accordance with international\r\n        guidelines Who underwent a cerebral CT-scan\r\n\r\n        Exclusion Criteria:\r\n\r\n        Ongoing treatment with anticoagulants or antiplatelets Pregnant women Persons without\r\n        national health insurance cover Children less than 15 years old Under guardianship.\r\n      ","sponsor":"Centre Hospitalier Universitaire Dijon","sponsor_type":"Other","conditions":"Traumatic Brain Injury","interventions":[{"intervention_type":"Other","name":"Other: death"}],"outcomes":[{"outcome_type":"primary","measure":"Early death","time_frame":"Through the study completion up to 2 years"}]}
{"nct_id":"NCT02452658","start_date":"2015-05-31","phase":"N/A","enrollment":311,"brief_title":"Fast Food Photo Study 2","official_title":"Detecting Changes on Fast Food Menu","primary_completion_date":"2015-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-01-31","last_update":"2016-01-27","description":"Participants will be exposed to a hypothetical fast food menu, asked to place a hypothetical lunch order, and will then be exposed to a second menu with several changes made to the menu. Participants will be asked to identify as many changes as possible on this second menu, and then complete a survey about their eating tendencies and demographics.","other_id":"HS14-582 Study 2","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18 or older,\r\n\r\n          -  agrees to consent form\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  N/A\r\n      ","sponsor":"Carnegie Mellon University","sponsor_type":"Other","conditions":"Obesity","interventions":[{"intervention_type":"Other","name":"Other: Changed menu","description":"After making the hypothetical choice, participants will be exposed to a menu with changed calorie and price labels, as well as several other changes."}],"outcomes":[{"outcome_type":"primary","measure":"Number of participants who notice calorie change","time_frame":"Participants will have 2 minutes to notice changes on the menu"},{"outcome_type":"primary","measure":"Number of participants who notice price change","time_frame":"Participants will have 2 minutes to notice changes on the menu"},{"outcome_type":"secondary","measure":"Within-participant ranking of the order in which changes were noticed","time_frame":"Participants will have 2 minutes to notice changes on the menu"},{"outcome_type":"secondary","measure":"Total number of changes noticed","time_frame":"Participants will have 2 minutes to notice changes on the menu"}]}
{"nct_id":"NCT02481011","start_date":"2015-05-31","enrollment":22111,"brief_title":"Risk of Intracranial Hemorrhage in Users of Oral Antithrombotic Drugs","official_title":"Risk of Intracranial Hemorrhage in Users of Oral Antithrombotic Drugs: a Nationwide Study","primary_completion_date":"2016-01-01","study_type":"Observational","rec_status":"Completed","completion_date":"2016-01-01","last_update":"2018-08-28","description":"The true incidence and risks of intracranial hemorrhage (ICH) in patients on various antithrombotic treatments remain unknown. Here a nationwide study is conducted to investigate the risk for and incidence rates of ICH in users and non-users of various oral antithrombotic drugs in Norway between 2008 through 2014. Hopefully, this study will contribute to a more responsible prescription pattern of antithrombotic medications.","other_id":"2014/7958","observational_model":"Case-Only","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"patients with intracranial hemorrhage admitted to hospitals in Norway 2008-2014","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  hospitalization due to intracranial hemorrhage (ICH)\r\n\r\n          -  residential address in Norway\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Traumatic (high-energy) intracranial injury\r\n\r\n          -  Parenteral antithrombotic treatment\r\n\r\n          -  ICH related to tumor or vascular malformation\r\n      ","sponsor":"St. Olavs Hospital","sponsor_type":"Other","conditions":"Intracranial Hemorrhages|Stroke","interventions":[{"intervention_type":"Drug","name":"Drug: antithrombotic drugs"}],"outcomes":[{"outcome_type":"primary","measure":"incidence rate of intracranial hemorrhage (ICH) requiring hospitalization","time_frame":"6 years","description":"We will determine the incidence rates of ICH in users and non-users of oral antithrombotic treatment by linking data from Norwegian Patient Register (NPR) and the Norwegian prescription database."},{"outcome_type":"secondary","measure":"overall survival following ICH","time_frame":"6 years","description":"comparison of users and non-users of oral antithrombotic drugs"},{"outcome_type":"secondary","measure":"proportion of ICH patients undergoing neurosurgical procedures","time_frame":"6 years","description":"comparison of users and non-users of oral antithrombotic drugs"}]}
{"nct_id":"NCT02447133","start_date":"2015-05-31","phase":"N/A","enrollment":12,"brief_title":"TopQ Cut-off Score Validation Study for 3D OCT-1 Maestro","official_title":"TopQ Cut-off Score Validation Study for 3D OCT-1 Maestro","primary_completion_date":"2015-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-05-31","last_update":"2017-01-31","description":"The objective of this study is to validate the TopQ cutoff scores, which have been previously determined.","other_id":"Topcon 001-2015","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria\r\n\r\n          1. Participants must be at least 18 years of age\r\n\r\n          2. They must be able to complete all testing (all OCT scans)\r\n\r\n          3. They must volunteer to be in the study and sign the consent form\r\n\r\n        Exclusion Criteria\r\n\r\n          1. Subject with history of ocular disease or ocular pathology\r\n\r\n          2. TopQ score from baseline OCT scan (i.e., without any ND filters) is below the cut-off\r\n             value.\r\n      ","sponsor":"Topcon Medical Systems, Inc.","sponsor_type":"Industry","conditions":"Subjects Presenting With Normal Eyes","interventions":[{"intervention_type":"Device","name":"Device: 3D OCT-1 Maestro","description":"OCT Machine used for diagnostic purposes"}],"outcomes":[{"outcome_type":"primary","measure":"TopQ Cut Off","time_frame":"1 hour","description":"To validate the values of the predetermined TopQ score by showing the variability above and below the TopQ score of 25 for 12x9 Wide, 28 for 6x6 Macula, and 30 for 6x6 Disc scans."}]}
{"nct_id":"NCT02461446","start_date":"2015-05-31","enrollment":170,"brief_title":"Natural History Study of Individuals With Autism and Germline Heterozygous PTEN Mutations","official_title":"Natural History Study of Individuals With Autism and Germline Heterozygous PTEN Mutations","primary_completion_date":"2024-12-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2025-12-31","last_update":"2021-08-02","description":"The purpose of this study is to determine cross-sectional and longitudinal medical, behavioral, and cognitive differences between PTEN ASD and other groups, as well as to identify cognitive, neural systems, and molecular biomarkers specific to PTEN ASD. In addition, this study will be creating and maintaining a biorepository and linked phenotypic database for PTEN ASD.","other_id":"P00013150","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":1.5,"population":"170 patients will be enrolled for this study, over the age of 18 month old.","criteria":"\n        Inclusion Criteria\r\n\r\n          -  Individuals above the age of 18 months old at the time of consent who have\r\n             documentation of a clinical diagnosis of autism spectrum disorder and/or a verified\r\n             PTEN mutation from a medical or mental health professional for inclusion in the PTEN\r\n             ASD, PTEN no-ASD or ASD macrocephaly groups.\r\n\r\n          -  Macrocephaly (head circumference greater than or equal to 98th percentile) for\r\n             inclusion in the ASD macrocephaly group.\r\n\r\n          -  For youths, consent from parents or legal guardian. For adults, consent from self or\r\n             legal guardian.\r\n\r\n          -  Youths who are able (some young or severely impaired participants may not be able to\r\n             provide assent) will be asked to provide assent as per IRB guidelines.\r\n\r\n          -  Families with multiple children who meet the above inclusion criteria will be\r\n             permitted to have as many children participate as they wish. A separate consent form\r\n             will be filled out for each child enrolled in the study.\r\n\r\n          -  Primary communicative language must be English\r\n\r\n        Exclusion Criteria\r\n\r\n          -  Unwilling or unable to comply with study procedures and assessments\r\n\r\n          -  Clinically significant medical disease that would prohibit participation in the study\r\n             procedures.\r\n\r\n          -  For subjects ELIGIBLE FOR OPTIONAL imaging biomarker assessment: contraindications to\r\n             3T MRI scanning, such as metal implants/non-compatible medical devices or medical\r\n             conditions, including vagus nerve stimulator.\r\n\r\n          -  For subjects ELIGIBLE FOR EEG/ERP biomarker assessment: contraindications to EEG/ERP,\r\n             such as uncooperative or destructive behaviors preventing lead placement or capture by\r\n             ERP/VEP equipment. Under age 2 or over 11 at the time of enrollment.\r\n      ","sponsor":"Boston Children's Hospital","sponsor_type":"Other","conditions":"PTEN|ASD|Autism|Macrocephaly|PTEN Hamartoma Tumor Syndrome","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Change in verbal abilities at 12 months","time_frame":"12 months","description":"Verbal and non-verbal ability will be evaluated using Stanford Binet -5 or Mullen Scales of Early Learning (MSEL) at 12 months"},{"outcome_type":"primary","measure":"Change in communication ability at 12 months","time_frame":"12 months","description":"Communication ability will be evaluated using composite score of the Peabody Picture Vocabulary Test (PPVT-4)."},{"outcome_type":"primary","measure":"Change in communication ability at 12 months","time_frame":"12 months","description":"Communication ability will be evaluated using composite score of the Expressive Vocabulary Test (EVT-2) at 12 months."},{"outcome_type":"primary","measure":"Change in verbal abilities at 24 months","time_frame":"24 months","description":"Verbal and non-verbal ability will be evaluated using Stanford Binet 5 or Mullen Scales of Early Learning (MSEL) at 24 months"},{"outcome_type":"primary","measure":"Change in visual perception at 12 months","time_frame":"12 months","description":"Visual perception will be measured using the Beery Developmental Test of Visuomotor Integration (VMI) at 12 months"},{"outcome_type":"primary","measure":"Change in working memory at 12 months","time_frame":"12 months","description":"Working memory will be evaluated using the Stanford Binet 5 at 12 months"},{"outcome_type":"primary","measure":"Change in processing speed at 12 months","time_frame":"12 months","description":"Processing Speed will be measured using the Processing Speed Index from the Weschler Intelligence Scales at 12 months"},{"outcome_type":"primary","measure":"Change in working memory at 24 months","time_frame":"24 months","description":"Working memory will be evaluated using the Stanford Binet 5 at 24 months"},{"outcome_type":"primary","measure":"Change in processing speed at 24 months","time_frame":"24 months","description":"Processing Speed will be measured using the Processing Speed Index from the Weschler Intelligence Scales at 24 months"},{"outcome_type":"primary","measure":"Change in visual perception at 24 months","time_frame":"24 months","description":"Visual perception will be measured using the Beery Developmental Test of Visuomotor Integration (VMI) at 24 months"},{"outcome_type":"primary","measure":"Change in communication ability at 24 months","time_frame":"24 months","description":"Communication ability will be evaluated using composite score of the Peabody Picture Vocabulary Test (PPVT-4) at 24 months"},{"outcome_type":"primary","measure":"Change in communication ability at 24 months","time_frame":"24 months","description":"Communication ability will be evaluated using composite score of the Expressive Vocabulary Test (EVT-2) at 24 months."}]}
{"nct_id":"NCT02486003","start_date":"2015-05-31","enrollment":329,"brief_title":"Testing mTBI in Athletes","official_title":"The Use of a Portable 3D Head Mounted Display (HMD) With Integrated Eye Capture Technology for the Diagnosis of Dizziness Associated With Mild Traumatic Brain Injury (mTBI)","primary_completion_date":"2017-08-14","study_type":"Observational","rec_status":"Completed","completion_date":"2017-08-14","last_update":"2017-12-22","description":"This study will assess the effectiveness of a portable goggle system in the diagnosis of mild traumatic brain injury (mTBI) in athletes.","other_id":"20150361","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":40,"population":"Subjects will be recruited from the population of athletes in the intercollege athletic\r\n        programs at the University of Miami. This will include athletes in NCAA Sports as well as\r\n        intercollege club sports. Aged and sex matched controls will be collected from the general\r\n        student body of the University of Miami.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Males and females from 18 - 40 years of age who participate in intercollegiate\r\n             athletics at the University of Miami to include all levels of sports whether NCAA or\r\n             club. Initial recruitment will include high intensity sports alone (these include but\r\n             are not limited to football, Men's and Women's Soccer, Men's and Women's Basketball,\r\n             Men's Baseball and Women's Softball, and club sports to include Men's and Women's\r\n             Lacrosse, Hockey, Rugby, and Field Hockey).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of brain injury resulting from a penetrating wound to the head.\r\n\r\n          -  Presence of severe aphasia\r\n\r\n          -  History of diagnosed neuropsychiatric disorders (e.g. hypochondriasis, major\r\n             depression, schizophrenia\r\n\r\n          -  Documented neurodegenerative disorders\r\n\r\n          -  Pregnancy, [Female candidates will be asked if they are pregnant]\r\n\r\n          -  Prior disorders of hearing and balance including:\r\n\r\n               1. Meniere's disease\r\n\r\n               2. Multiple sclerosis\r\n\r\n               3. Vestibular neuritis\r\n\r\n               4. Vestibular schwannoma\r\n\r\n               5. Sudden sensorineural hearing loss\r\n\r\n          -  Cerebrovascular disorders\r\n\r\n          -  History of ear operation other than myringotomy tube in the past\r\n\r\n          -  Systemic disorders: e.g. chronic renal failure, cirrhosis of the liver, etc.\r\n      ","sponsor":"University of Miami","sponsor_type":"Other","conditions":"Mild Traumatic Brain Injury|Brain Concussion","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Vestibular, oculomotor, and reaction time test results","time_frame":"3 months","description":"IPAS testing will be conducted by placing the IPAS goggles on the head of a patient and asking the patient to follow instructions while a set of tests is performed. Each of these tests simply involves eye motions in response to a target."}]}
{"nct_id":"NCT02877472","start_date":"2015-05-31","phase":"N/A","enrollment":100,"brief_title":"Porous Tantalum Rods Improve the Hip Joint Function of Patients With Avascular Necrosis of the Femoral Head","official_title":"Porous Tantalum Rods Improve the Hip Joint Function of Patients With Avascular Necrosis of the Femoral Head After Femoral Neck Fracture Surgery: a Randomized Controlled Trial","primary_completion_date":"2016-10-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2017-05-31","last_update":"2016-08-24","description":"To confirm 1) whether, compared with core decompression alone, core decompression with porous tantalum rod implantation improves the hip joint function of patients with avascular necrosis of the femoral head after femoral neck fracture surgery, 2) whether porous tantalum rod shows favorable biocompatibility with the human body, and 3) whether this treatment method is feasible for treating avascular necrosis of the femoral head after femoral neck fracture surgery.","other_id":"QinghaiUH_003","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with fracture nonunion as indicated by a clear fracture line 12 months after\r\n             femoral neck fracture; avascular necrosis of the femoral head as shown by cystic\r\n             degeneration, sclerosis, and uneven density on X-ray images and CT scans\r\n\r\n          -  Patients with avascular necrosis of the femoral head after femoral neck fracture\r\n             surgery who underwent internal fixation between 1 January 2016 and 31 May 2017\r\n\r\n          -  Age 18-80 years\r\n\r\n          -  Any sex and nationality\r\n\r\n          -  Provision of signed informed consent to participate in the trial\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Poor general health\r\n\r\n          -  Chronic disease or history of surgery\r\n\r\n          -  Alcohol abuse or long-term use of hormone drugs\r\n\r\n          -  Unable or declines to cooperate with treatment and examination because of language\r\n             and/or mental disorders\r\n\r\n          -  Unable or declines to cooperate with rehabilitation treatment because of mental and/or\r\n             psychological disorders\r\n      ","sponsor":"Qinghai University","sponsor_type":"Other","conditions":"Femoral Neck Fracture","interventions":[{"intervention_type":"Device","name":"Device: porous tantalum rod","description":"Patients with avascular necrosis of the femoral head after femoral head fracture surgery receive treatment of core decompression and porous tantalum rod implantation"},{"intervention_type":"Procedure","name":"Procedure: core decompression","description":"Patients with avascular necrosis of the femoral head after femoral head fracture surgery will undergo core decompression."}],"outcomes":[{"outcome_type":"primary","measure":"Harris hip scores","time_frame":"12 months after surgery","description":"To evaluate the recovery of hip joint function. The Harris hip score ranges from 0-100 points with higher scores indicating better hip joint function. Hip joint function is scored as follows: ≥ 90 is excellent, 80-89 very good, 70-79 good, and < 70 poor."},{"outcome_type":"secondary","measure":"Visual Analogue Scale (VAS)","time_frame":"prior to and 1, 6, and 12 months after surgery","description":"To evaluate the severity of pain and ranges from 0-10, with higher scores indicating more severe pain."},{"outcome_type":"secondary","measure":"Incidences of complications","time_frame":"6 and 12 months after surgery","description":"To evaluate the safety of various implantation methods."}]}
{"nct_id":"NCT02607397","start_date":"2015-05-31","enrollment":25,"brief_title":"ROCOCO - Low Grade Glioma - Planning Study","official_title":"In Silico Clinical Trial on Irradiation Low Grade Glioma, Comparing Photon and Proton Therapy: A Multicentric Planning Study Based on a Reference Dataset of Patients","primary_completion_date":"2017-03-31","study_type":"Observational","rec_status":"Completed","completion_date":"2017-03-31","last_update":"2017-03-28","description":"The cost of particle therapy (PT) are considerably higher than conventional radiotherapy (RT) with photons. Considering potential dosimetric advantages of PT, it is necessary to determine if PT are more cost-effective than photons per indication regarding quality of life, survival, and progression free survival. Given the lack of evidence for the benefit of particle therapy in relevant cases, investigators proposed an in silico trial to investigate to what extend proton therapy decrease the amount of irradiated normal tissue and, consequently, the risk of side effects in the surrounding normal tissue as well as the risk of secondary tumors. Given validated dose-response curves and/or NTCP models, a 10% lower mean dose of proton therapy on normal tissue compared to photon therapy should result in at least a 20% lower risk of side effects.","other_id":"ROCOCO LGG","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"25 patients. Each patient will function as his or her own control.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Low Grade Glioma patients\r\n\r\n          -  Treated with radical intent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  No Low Grade Glioma\r\n      ","sponsor":"Maastricht Radiation Oncology","sponsor_type":"Other","conditions":"Low Grade Glioma","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Dmean","time_frame":"1 month","description":"The normal tissue dose volume parameters per tumor type are defined as Hippocampus: Dmean"},{"outcome_type":"primary","measure":"Dmax","time_frame":"1 month","description":"The normal tissue dose volume parameters per tumor type are defined as Hippocampus: Dmax"},{"outcome_type":"secondary","measure":"Normal Tissue Complication Probability","time_frame":"1 month","description":"Based on the OAR's radiation exposure, normal tissue complication probability (NTCP) will be calculated using existing models or existing dose response curves."}]}
{"nct_id":"NCT02449226","start_date":"2015-05-31","enrollment":51,"brief_title":"Accuracy of Point-of-Care Measurement With the RapidPoint 500 Blood Gas Analyser","official_title":"Accuracy of Point-of-Care Measurement of Electrolytes, Glucose, Hemoglobin and Hematocrit With the RapidPoint 500 Blood Gas Analyser","primary_completion_date":"2015-06-30","study_type":"Observational","rec_status":"Completed","completion_date":"2016-02-29","last_update":"2016-02-23","description":"ICU patients are at high risk of ionic or metabolic disturbances during the course of their critical illness. Some of these disturbances might be life-threatening and require rapid response from physicians. Point-of-Care determination of electrolytes, glucose, hemoglobin and hematocrit ensures early detection (within 1 minute) of abnormal values and allows rapid and appropriate therapy. This technology has largely improved the quality of care in ICU. However, the accuracy of the measurement of those parameters had to be close enough to the reference method, usually perfomed in the central lab but time consuming. Recently, a novel generation of blood gas analyser has been released. Among them, the RapidPoint 500 is mounted with a 28-day cartridge which provides automatic calibrations and quality controls several times a day. Such a technology dramatically decreases the need for labs technical interventions. To date, there is no data reporting the accuracy of this device. Therefore, the investigators' aim is to compare the accuracy of the RapidPoint 500 with a reference measurement performed at the central laboratory (Beckman&Coulter AU5800 for electrolytes and Beckman&Coulter DXH for hemoglobin).","other_id":"2015-A00718-41","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"All patients staying in our ICU and equipped with an indwelling arterial catheter for whom\r\n        clinicians prescribe together an arterial blood gas analysis and a biological laboratory\r\n        analysis.\r\n\r\n        The study will take place over a 1 month period. A total of 300 pairs of samples is\r\n        targeted.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Current stay in ICU\r\n\r\n          -  Presence of an indwelling arterial catheter (radial or femoral)\r\n\r\n          -  Prescription by physicians of a blood gas analysis and a laboratory analysis for the\r\n             next morning\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  None\r\n      ","sponsor":"Hpital Europen Marseille","sponsor_type":"Other","conditions":"Critical Care|Electrolytes|Point-of-Care Systems","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"bias and limit of agreement","time_frame":"1 month","description":"to describe the bias and limit of agreement between the tested method and the reference method for electrolytes, glucose, hemoglobin and hematocrit."},{"outcome_type":"primary","measure":"Dumming regression analysis","time_frame":"1 month","description":"to describe the relation between the tested method and the reference method for electrolytes, glucose, hemoglobin and hematocrit."},{"outcome_type":"primary","measure":"Coefficient of correlation (Pearson)","time_frame":"1 month","description":"to describe the correlation between the tested method and the reference method for electrolytes, glucose, hemoglobin and hematocrit."}]}
{"nct_id":"NCT02034409","start_date":"2015-05-29","phase":"Phase 1/Phase 2","enrollment":180,"brief_title":"A Pilot Trial to Assess Low-Intensity Ultrasound in Osteoarthritis","official_title":"A Pilot Trial to Assess Low-Intensity Ultrasound in Osteoarthritis","primary_completion_date":"2020-06-01","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2021-09-30","last_update":"2020-11-16","description":"The purpose of this exploratory trial is to investigate whether PLIUS is potentially effective as a disease and symptom modifying intervention in patients with early knee OA.","other_id":"CLIN-006-13S","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","intervention_model_description":"Participants in this double-blind, randomized, sham-controlled trial will be randomly assigned to receive either sham or PLIUS device for 48 weeks.","sampling_method":"","gender":"All","minimum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  40 years of age or older, and a US Military Veteran\r\n\r\n          -  Clinical symptoms of osteoarthritis for at least 6 months\r\n\r\n          -  Pain in the index knee on motion or weight bearing for the majority of days during the\r\n             month before screening\r\n\r\n          -  Clinical diagnosis of primary osteoarthritis of the knee based on clinical and\r\n             radiographic criteria\r\n\r\n          -  American Rheumatism Association Functional Class I, II, or III\r\n\r\n          -  Females of childbearing potential must be willing to use a reliable form of medically\r\n             acceptable contraception\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Concurrent medical/arthritis condition(s), or any other illness per the opinion of the\r\n             investigator, that could interfere with the evaluation of pain or efficacy\r\n\r\n          -  Spine or hip pain of significant magnitude\r\n\r\n          -  History of significant ligament or meniscal injury of the index joint requiring\r\n             surgical repair\r\n\r\n          -  Arthroscopy of the index knee within 6 months of study entry\r\n\r\n          -  Unable to undergo MRI of the knee\r\n\r\n          -  Pregnancy or lactation\r\n\r\n          -  Corticosteroid treatment within 1 to 3 months prior to study entry\r\n\r\n          -  Intra-articular injection of hyaluronic acid or congeners to the index knee within 6\r\n             months of study entry\r\n\r\n          -  Use of excluded therapy(ies) prior to study entry\r\n\r\n          -  Use of disease modifying anti-rheumatic medications and chronic tetracycline or its\r\n             derivatives\r\n\r\n          -  Exposure to glucosamine, chondroitin sulfate, or any other investigational treatment,\r\n             within 1 month of study entry\r\n\r\n          -  Use of any medical therapy, complementary or alternative regimens for the treatment of\r\n             osteoarthritis within 7 days prior to study entry\r\n\r\n          -  Initiation of physical therapy or muscle conditioning program to the lower extremities\r\n             within 2 months within 2 months prior to study entry\r\n\r\n          -  Unlikely to comply with study requirements\r\n      ","sponsor":"VA Office of Research and Development","sponsor_type":"U.S. Fed","conditions":"Osteoarthritis, Degenerative","interventions":[{"intervention_type":"Device","name":"Device: Pulsed Low Intensity Ultrasound","description":"20 minutes daily for 48 weeks"},{"intervention_type":"Device","name":"Device: Sham Comparator","description":"20 minutes daily for 48 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Co-Primary Measure: a) Symptom reduction","time_frame":"48 weeks","description":"Co-Primary Measure: a) Symptom reduction as measured by OMERACT-OARSI Responder Criteria"},{"outcome_type":"primary","measure":"Co-Primary Measure: b) Disease-modification","time_frame":"48 weeks","description":"Co-Primary Measure: b) Disease-modification as measured by MRI determined cartilage thickness"}]}
{"nct_id":"NCT02412644","start_date":"2015-05-28","phase":"Phase 4","enrollment":29,"brief_title":"Apremilast 30mg Bid With Narrowband UVB in the Treatment of Plaque Psoriasis","official_title":"Efficacy and Safety of Combining Apremilast 30mg Bid With Narrowband UVB in the Treatment of Moderate-to-severe Plaque Psoriasis","primary_completion_date":"2016-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-07-31","last_update":"2019-01-28","description":"12 weeks open label with Otezla and NUVB, followed by 6 month double blind Otezla (apremilast) or placebo to subjects who obtain PASI 75 at week 12 of phototherapy","other_id":"AP-CL-PSOR-PI-004893","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria: Subjects must meet the following criteria to be enrolled in this study:\r\n\r\n          1. Male or female adult  18 years of age;\r\n\r\n          2. Diagnosis of chronic plaque-type\r\n\r\n          3. Moderate to severe plaque type psoriasis as defined at baseline by:\r\n\r\n               -  PASI score of 12 or greater,\r\n\r\n               -  PGA score of 3 or greater\r\n\r\n               -  BSA affected by plaque-type psoriasis of 10% or greater,\r\n\r\n          4. Able and willing to give written informed consent prior to performance of any\r\n             study-related procedures\r\n\r\n        Exclusion Criteria:\r\n\r\n        Subjects who meet any of the following criteria will be excluded from participation in this\r\n        study:\r\n\r\n          1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic,\r\n             and/or guttate psoriasis) or drug induced psoriasis\r\n\r\n          2. Subjects with previous exposure to apremilast\r\n\r\n          3. Malignancy or history of malignancy, except for:\r\n\r\n               -  treated [ie, cured] basal cell or squamous cell in situ skin carcinomas;\r\n\r\n               -  treated [ie, cured] malignancy with no evidence of recurrence within the previous\r\n                  5 years.\r\n      ","sponsor":"Psoriasis Treatment Center of Central New Jersey","sponsor_type":"Other","conditions":"Plaque Psoriasis","interventions":[{"intervention_type":"Drug","name":"Drug: apremilast"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants Maintaining Psoriasis Area Severity Index Score (PASI) 75 at Week 36","time_frame":"36weeks","description":"Analysis of Psoriasis Area Severity Index Score at week 36 to determine number of subjects who maintained PASI 75 at week 36"},{"outcome_type":"secondary","measure":"Number of Subjects Achieving Psoriasis Area Severity Index Score (PASI) 75 Response at Week 12","time_frame":"12WEEKS","description":"Psoriasis Area Severity Score of 75 or greater at week 12"},{"outcome_type":"secondary","measure":"Number of Subjects Achieving Psoriasis Area Severity Index Score 90 at Week 36","time_frame":"36 weeks","description":"PASI 90 or greater at week 36"},{"outcome_type":"secondary","measure":"Number of Subjects Achieving Physician Global Assessment Score of 0 or 1 at Week 36","time_frame":"36 weeks","description":"PGA score 0 or 1"}]}
{"nct_id":"NCT02872246","start_date":"2015-05-26","phase":"N/A","enrollment":11,"brief_title":"Sun Protection Factor (SPF) / UVA Protection Factor (UVAPF) - Assay","official_title":"Sun Protection Factor (SPF) / UVA Protection Factor (UVAPF) Assay","primary_completion_date":"2015-07-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-07-01","last_update":"2018-12-12","description":"Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection Factor (SPF) on the skin of human subjects.","other_id":"18321","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female of an age of 18 to 70 years inclusive;\r\n\r\n          -  Fitzpatrick Skin Type I, II and/or III for SPF testing;\r\n\r\n          -  Good health as determined from the CRO Subject History Form (SHF);\r\n\r\n          -  Signed and dated Informed Consent Form;\r\n\r\n          -  Signed and dated Health Insurance Portability and Accountability Act (HIPAA) Form;\r\n\r\n          -  An unambiguous minimal erythema dose (MED).\r\n      ","sponsor":"Bayer","sponsor_type":"Industry","conditions":"Sunscreen Agents","interventions":[{"intervention_type":"Drug","name":"Drug: BAY 987516","description":"Single dose application of two (2) mg/cm of test product. Each 50 cm test site area requires 100 mg of a product to obtain a standard 2 mg/cm test application."},{"intervention_type":"Drug","name":"Drug: SPF 15 Control","description":"Single dose application of two (2) mg/cm of test product. Each 50 cm test site area requires 100 mg of a product to obtain a standard 2 mg/cm test application."}],"outcomes":[{"outcome_type":"primary","measure":"Evaluation of water resistant SPF","time_frame":"16-24 hours post exposure","description":"For the sunscreen Test Material, two test sites were used; one for before immersion and one for after 2 hours of water immersion. One additional test site area was used for the control SPF determination, on each subject, as per the COLIPA Sun Protection Factor Test Method."}]}
{"nct_id":"NCT02252003","start_date":"2015-05-21","phase":"N/A","enrollment":70,"brief_title":"Development and Validation of a New Pain Scale for Children","official_title":"Development of a New Pain Rating Scale for Children and Validation Against Criteria by Comparison With Faces Pain Scale - Revised (FPS-R) and Visual Analogue Scale (VAS)","primary_completion_date":"2017-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-07-31","last_update":"2018-02-14","description":"In clinical practice with young children, gold standard rating scales used to evaluate the pain are VAS (Visual Analogue Scale) and FPS-R (Faces Pain Scale - Revised), which are self-assessment tools. These scales present however certain limitations: the VAS is not applicable if the child does not know how to estimate the distances, as young children, or children with mental retardation. As for FPS-R, it can be frightening for children by the aspect of faces looking like impersonal masks. For children under 4 years, only hetero-evaluation based on typical behavioral scales as Face Legs Activity Cry Consolability (FLACC) can be used, according to the current recommendations. We thus wanted to create a new faces scale with teddy bear faces, which are cross-cultural and timeless. Our objective is to validate the new teddy scale in its paper shape on a wide sample of children. We made the hypothesis that the teddy scale would enable to evaluate the pain in the same way that the FPS-R, being better accepted and preferred by children. The first phase of this study will be to develop the teddy scale with a sample of 30 healthy children from 4 to 11 year-old, having already experienced pain. This stage allows the validation of the images chosen for the scale, to make sure of their relevance and their optimal recognition by the children. The scale will then be validated with a sample of 218 hospitalized children from 2 to 11 years old, to whom pain is usually evaluated in a systematic way. Children from 4 to 11 years old will have simultaneously the teddy scale, the VAS and the FPS-R. They will be asked to determine which scale they preferred. Children from 2 to 4 years old will have the teddy scale; the FLACC will be filled in by parents. Tested hypothesis: The discriminating characteristic of the teddy scale is superior to that of the FPS-R scale The validation of the teddy scale will enable to objectify children's pain, to facilitate the decision-making in the choice of the analgesic to prescribe, and to check the efficiency of these decisions. This teddy scale could be used in current practice as a replacement of the FPS-R. Following this study, we planned to set up a second project in which the teddy scale will be adapted to electronic form (touchpads), to test its adaptability with the children.","other_id":"2013.811","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":2,"maximum_age":11,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Affiliated with the French healthcare system\r\n\r\n          -  Agreed to participate in the study, of which parents/ holders of parental authority\r\n             signed the informed consent form\r\n\r\n        Scale development phase:\r\n\r\n          -  Children aged from 4 to 11 years at inclusion\r\n\r\n          -  Having already experienced pain\r\n\r\n        Scale validation phase:\r\n\r\n          -  Children aged from 2 to 11 years old at inclusion\r\n\r\n          -  Hospitalized in one of the Hpital Femme-Mre-Enfant (HFME) departments\r\n\r\n          -  At risk of presenting pain, that is to whom the pain is usually evaluated in a\r\n             systematic way\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Children among whom the understanding and/or the language is not sufficient to allow a\r\n             good comprehension of study instructions\r\n\r\n          -  Children participating simultaneously in another interventional research, being able\r\n             to interfere with the study results\r\n      ","sponsor":"Hospices Civils de Lyon","sponsor_type":"Other","conditions":"Pain","interventions":[{"intervention_type":"Other","name":"Other: Pain scales testing"}],"outcomes":[{"outcome_type":"secondary","measure":"Scale preference (4-11 years old)","time_frame":"Baseline","description":"The 174 patients (aged 4-11 years old) will be asked to choose the scale they preferred between teddy scale, VAS and FPS-R. The number of times where the teddy scale is preferred will be counted (result expressed in percentage) and compared to the 2 other scales."},{"outcome_type":"primary","measure":"Pain assessment (4-11 years old)","time_frame":"Baseline","description":"Children aged 4-11 will be asked to score the pain they feel at that time, using the 3 scales presented in a randomly assigned order. The measure of the correlation between the scores of the 3 pain scales: VAS score (continuing : 0.0 to 10.0), FPS-R score (0,2,4,6,8,10), and teddy scale score (0,2,4,6,8,10) will be evaluated."},{"outcome_type":"secondary","measure":"Pain assessment (4-11 years old) depending on age.","time_frame":"Baseline","description":"Children aged 4-11 will be asked to score the pain they feel at that time, using the 3 scales presented in a randomly assigned order. The measure of discriminating characteristics of each scale (teddy scale, FPS-R and VAS), according to the age (continuing age, or in range: 4-6, 6-8 and 8-11) will be performed."},{"outcome_type":"secondary","measure":"Sensibility of change of teddy and FPS-R scales","time_frame":"Baseline","description":"The sensibility of change (before/after treatment intake) will be measured by the size-effect (mean of the differences divided by the standard deviation before treatment) and by standardized mean responses (mean of the differences divided by the differences standard deviations)."},{"outcome_type":"secondary","measure":"Pain assessment (2-3 years-old)","time_frame":"Baseline","description":"Children aged 2-3 years old will be asked to score the pain they feel at that time, using the teddy scale while parents will fill up the FLACC scale. The measure of the correlation between scores of the 2 pain scales: teddy scale score (0,2,4,6,8,10) and FLACC score (continuing from 0 to 10), will be performed using statistical models."}]}
{"nct_id":"NCT02667860","start_date":"2015-05-20","phase":"N/A","enrollment":140,"brief_title":"Intra-corporeal vs Extra-corporeal Anastomosis in Laparoscopically Assisted Right Hemicolectomy","official_title":"Intra-corporeal vs Extra-corporeal Anastomosis in Laparoscopically Assisted Right Hemicolectomy","primary_completion_date":"2018-06-21","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-07-21","last_update":"2019-01-14","description":"The creation of an intracorporeal anastomosis during right hemicolectomy is regarded as superior than the extracorporeal anastomosis in terms of recovery of peristalsis, aesthetic results, analgesia requirements and length of hospital stay. The objective of this study is to compare the postoperative results of intracorporeal versus extracorporeal anastomosis in patients undergoing laparoscopic right hemicolectomy.","other_id":"IIBSP-AIE-2015-01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":99,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Surgical procedure with curative purpose.\r\n\r\n          -  American Society of Anaesthesiologists Physical Status (ASA) I, II and III.\r\n\r\n          -  Elective surgery.\r\n\r\n          -  Informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Denial of informed consent.\r\n\r\n          -  Advanced neoplasia.\r\n\r\n          -  Urgent surgery.\r\n\r\n          -  ASA IV.\r\n      ","sponsor":"Fundaci Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau","sponsor_type":"Other","conditions":"Pain","interventions":[{"intervention_type":"Procedure","name":"Procedure: Intracorporeal anastomosis.","description":"Iso or anti-peristaltic side-to-side ileo-colonic anastomosis with Echelon Endopatch and closure of the defect with running suture or another firing of Echelon Endopatch. The surgical specimen will be retrieved through a Pfannenstiel incision."},{"intervention_type":"Procedure","name":"Procedure: Extracorporeal anastomosis","description":"A transverse incision in the right upper quadrant will be performed. An iso or anti-peristaltic side-to-side ileo-colonic anastomosis with Proximate Linear Cutter device and Proximate Stapler."},{"intervention_type":"Device","name":"Device: Echelon Endopatch","description":"Use of an Echelon Endopatch Powered Device to perform an ileocolonic side-to-side anastomosis."},{"intervention_type":"Device","name":"Device: Proximate Linear Cutter","description":"Use of a Proximate Linear Cutter device to perform a side-to-side ileo-colonic anastomosis.Use of a Proximate stapler to the closure of the defect associated with the creation of the side-to-side ileo-colonic anastomosis."}],"outcomes":[{"outcome_type":"primary","measure":"Length of stay","time_frame":"1 month","description":"is identified when the patient has tolerated diet and has had bowel movements and is discharged from the hospital"},{"outcome_type":"secondary","measure":"Return to normal peristalsis","time_frame":"1 week","description":"Physiological parameter"},{"outcome_type":"secondary","measure":"Size of the surgical wound","time_frame":"1 month","description":"we measure the wound in cm"},{"outcome_type":"secondary","measure":"Rate of Surgical Site Infection","time_frame":"1 month","description":"clinical wound infection or positive culture"},{"outcome_type":"secondary","measure":"Rate of Incisional Hernia","time_frame":"1 year after discharge","description":"Physical exploration and CT scan (performed during the follow up)"},{"outcome_type":"secondary","measure":"Aesthetic result","time_frame":"1 month after discharge","description":"Questionnaire"},{"outcome_type":"secondary","measure":"Postoperative pain","time_frame":"1 month after discharge","description":"Questionnaire"}]}
{"nct_id":"NCT02339285","start_date":"2015-05-07","phase":"N/A","enrollment":32,"brief_title":"Transcranial Alternating Current Stimulation for Major Depressive Disorder","official_title":"Pilot Clinical Trial for the Evaluation of Feedback Transcranial Alternating Current Stimulation for the Treatment of Major Depressive Disorder","primary_completion_date":"2017-06-19","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-06-19","last_update":"2018-08-20","description":"Investigating the effects of non-invasive transcranial alternating current stimulation (tACS) on patients with Major Depressive Disorder (MDD).","other_id":"14-1622","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female, 18-65 years old\r\n\r\n          -  Diagnostic and Statistical Manual of Mental Disorder, 4th edition (DSM-IV) diagnosis\r\n             of MDD; unipolar, non-psychotic\r\n\r\n          -  Hamilton Depression Rating Scale score >8\r\n\r\n          -  Capacity to understand all relevant risks and potential benefits of the study\r\n             (informed consent)\r\n\r\n          -  Meet criteria for low suicide risk\r\n\r\n          -  Willing to comply with all study procedures and be available to do so for the duration\r\n             of the study\r\n\r\n          -  Women of reproductive potential must use highly effective contraception\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  DSM-IV diagnosis of alcohol of substance abuse (other than nicotine) within the last\r\n             month or a DSM-IV diagnosis of alcohol or substance dependence (other than nicotine)\r\n             within the last 6 months\r\n\r\n          -  Current use of benzodiazepines or anti-epileptic drugs\r\n\r\n          -  Current axis I mood, or psychotic disorder other than major depressive disorder\r\n\r\n          -  Lifetime comorbid psychiatric bipolar or psychotic disorder\r\n\r\n          -  Eating disorder (current or within the past 6 months)\r\n\r\n          -  Obsessive-compulsive disorder (lifetime)\r\n\r\n          -  Post traumatic stress disorder (PTSD; current or within the last 6 months)\r\n\r\n          -  Attention Deficit Hyperactivity Disorder (ADHD; currently under treatment)\r\n\r\n          -  Anything that, in the opinion of the investigator, would place the participant at\r\n             increased risk or preclude the participant's full compliance with or completion of the\r\n             study\r\n\r\n          -  Neurological disorders, including but not limited to history of seizures (except\r\n             childhood febrile seizures and ECT induced seizures), dementia, history of stroke,\r\n             Parkinson's disease, multiple sclerosis, cerebral aneurism\r\n\r\n          -  Medical or neurological illness (unstable cardiac disease, AIDS, malignancy, liver or\r\n             renal impairment) or treatment for a medical disorder that could interfere with study\r\n             participation\r\n\r\n          -  History of traumatic brain injury, reoccurring seizures or later cognitive\r\n             rehabilitation, or causing cognitive sequelae\r\n\r\n          -  Prior brain surgery\r\n\r\n          -  Any brain devices/implants, including cochlear implants and aneurysm clips\r\n\r\n          -  Co-morbid neurological condition (i.e. seizure disorder, brain tumor)\r\n\r\n          -  Non English speakers\r\n\r\n          -  Pregnancy, nursing, or if female and fertile, unwilling to use appropriate birth\r\n             control measures during study participation\r\n      ","sponsor":"University of North Carolina, Chapel Hill","sponsor_type":"Other","conditions":"MDD|Major Depressive Disorder","interventions":[{"intervention_type":"Device","name":"Device: tACS (alpha)"},{"intervention_type":"Device","name":"Device: tACS (gamma)"}],"outcomes":[{"outcome_type":"primary","measure":"Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score","time_frame":"Baseline to F2 (4 weeks after completion of the intervention)","description":"The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. This measurement will be taken at baseline (Day 1 of Stimulation), Day 5 of Stimulation, 2 weeks after completion of the intervention (F1), and 4 weeks after completion of the intervention (F2). A comparison of MADRS scores between baseline and F2 is the primary outcome measure (measured as change from baseline). In these results, negative values will indicate a decrease in depressive symptoms."},{"outcome_type":"secondary","measure":"Change in Alpha Oscillation Power From Resting State EEG Recordings on the First and Last Day of Stimulation","time_frame":"Baseline to Day 5 of Stimulation","description":"The investigators will compare alpha oscillation power from resting state EEG recordings on the first day of stimulation (baseline) and last day of stimulation. The investigators will also collect EEG recordings data at a visit four weeks after completion of the intervention (F2). The investigators will use each of the three EEG recordings as data to analyze alpha frequency activity as a pilot study for derivation of EEG biomarkers. As the stimulation paradigm stimulates the frontal brain regions, the investigators will analyze alpha power change in all brain regions as well as frontal regions."},{"outcome_type":"secondary","measure":"Change in Alpha Oscillation Power From Resting State EEG Recordings on the First of Stimulation to 4 Weeks After Completion of Intervention","time_frame":"Baseline to F2","description":"The investigators will compare alpha oscillation power from resting state EEG recordings on the first day of stimulation (baseline) and at the follow-up visit four weeks after completion of the intervention. The investigators will also collect EEG on the fifth day of stimulation. The investigators will use each of the three EEG recordings as data to analyze alpha frequency activity as a pilot study for derivation of EEG biomarkers. As the stimulation paradigm stimulates the frontal brain regions, the investigators will analyze alpha power change in all brain regions as well as frontal regions."},{"outcome_type":"other","measure":"Change in Hamilton Depression Rating Scale (HDRS) Score","time_frame":"Baseline to Day 5 of Stimulation; Baseline to F2","description":"The HDRS is a clinician-administered depression assessment and consists of 17 items with a total score range from 0 to 54. A higher score indicates a worse outcome. This measurement will be taken at baseline (Day 1 of Stimulation), Day 5 of Stimulation, 2 weeks after completion of the intervention (F1), and 4 weeks after completion of the intervention (F2). The investigators will compare the scores between baseline and F2, with negative values indicating a decrease in depressive symptoms."},{"outcome_type":"other","measure":"Change in Montreal Cognitive Assessment (MoCA) Score","time_frame":"Baseline to F2","description":"This measurement will be taken at baseline (first day of stimulation) and four weeks after completion of the intervention (F2). Total score ranges from 0 to 30, with higher values indicating better cognition. The investigators will compare the scores between baseline and F2. Reported values are the raw change (increase or decrease) from baseline."},{"outcome_type":"other","measure":"Change in Beck Depression Inventory (BDI) Score","time_frame":"Baseline to Day 5; Baseline to F2","description":"This measurement will be taken at baseline (Day 1 of Stimulation), Day 5 of Stimulation, 2 weeks after completion of the intervention (F1), and 4 weeks after completion of the intervention (F2). Higher scores indicate more depressive symptoms. Total score is out of 63 possible. The investigators will compare the scores between baseline and F2. In these results, negative values indicate a decrease in depressive symptoms."},{"outcome_type":"other","measure":"Clinical Global Impressions (CGI) Raw Score","time_frame":"Day 5; F2 (4 weeks after completion of treatment)","description":"This measurement will be taken at baseline (Day 1 of Stimulation), Day 5 of Stimulation, 2 weeks after completion of the intervention (F1), and 4 weeks after completion of the intervention (F2). The investigators will compare the scores between baseline and F2.The reported values are from Item 1 \"Severity of Illness\" on a likert scale of 1 to 7, with 1=Normal, not at all ill and 7 = Among the most extremely ill patients."}]}
{"nct_id":"NCT02452203","start_date":"2015-05-01","phase":"N/A","enrollment":56,"brief_title":"Examining the Effects of Reduced Environmental Stimulation on the Brain","official_title":"Examining the Effects of Reduced Environmental Stimulation on the Brain","primary_completion_date":"2019-12-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-12-31","last_update":"2020-09-22","description":"The studies proposed in this protocol aim to explore the anxiolytic properties of floating as it relates to the central and autonomic nervous system.","other_id":"float-fMRI-1","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Participants must be between 18-55 years of age, free of any current or past\r\n             neurological or psychiatric illness, and capable of performing all tasks during each\r\n             session of the experiment.\r\n\r\n          2. They must be able to provide written informed consent and must have sufficient\r\n             proficiency in the English language to understand and complete interviews,\r\n             questionnaires, and all other study procedures.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Participant meets criteria for a DSM5 Axis-1 disorder.\r\n\r\n          2. Participant endorses current suicidal ideation with intent or plan.\r\n\r\n          3. Participant fails to adhere to our \"Pre-float checklist\".\r\n\r\n          4. Participant is morbidly obese (BMI > 40).\r\n\r\n          5. Certain drugs or medications consumed within the past week including any psychoactive\r\n             drugs (e.g., benzodiazepines, opiates, selective serotonin reuptake inhibitors,\r\n             dopamine agonists, barbiturates, MDMA, LSD, psilocybin, peyote, phencyclidine,\r\n             ketamine). For all other medications, we require the participant to be stably\r\n             medicated prior to participation (defined as having taken the medication for 6 weeks\r\n             or longer).\r\n\r\n          6. Participant has a history of unstable liver or renal insufficiency; glaucoma;\r\n             diabetes; significant and unstable cardiac, vascular, pulmonary, gastrointestinal,\r\n             endocrine, neurologic, hematologic, rheumatologic, or metabolic disturbance; or any\r\n             other condition that, in the opinion of the investigator, would make participation not\r\n             be in the best interest (e.g., compromise the well-being) of the subject or that could\r\n             prevent, limit, or confound the protocol-specified assessments.\r\n\r\n          7. Pregnancy as detected by a urine test.\r\n\r\n          8. Non-correctable vision or hearing problems.\r\n\r\n          9. MRI contraindications including: cardiac pacemaker, metal fragments in eyes/skin/body\r\n             (shrapnel), aortic/aneurysm clips, prosthesis, by-pass surgery/coronary artery clips,\r\n             hearing aid, heart valve replacement, shunt (ventricular or spinal), electrodes, metal\r\n             plates/pins/screws/ wires, or neuro/bio-stimulators (TENS unit), persons who have ever\r\n             been a professional metal worker/welder, history of eye surgery/eyes washed out\r\n             because of metal, vision problems uncorrectable with lenses, inability to lie still on\r\n             one's back for 60-120 minutes; prior neurosurgery; tattoos or cosmetic makeup with\r\n             metal dyes, unwillingness to remove body piercings, and pregnancy.\r\n      ","sponsor":"Laureate Institute for Brain Research, Inc.","sponsor_type":"Other","conditions":"Anxiety","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Floating","description":"Floating in either a pool saturated with Epsom salt or in a zero-gravity chair"}],"outcomes":[{"outcome_type":"primary","measure":"Brain activation changes in limbic and paralimbic neural circuitry from pre- to post-float as measured with functional magnetic resonance imaging (fMRI)","time_frame":"fMRI will be undertaken before floating and then immediately following the 3rd float session, an average time frame of 3 weeks","description":"MRI scan to measure the blood flow changes in the brain"}]}
{"nct_id":"NCT01945268","start_date":"2015-04-30","phase":"Phase 4","enrollment":107,"brief_title":"Influenza Vaccine To Prevent Adverse Vascular Events:Pilot","official_title":"A Randomized Controlled Trial of Influenza Vaccine to Prevent Adverse Vascular Events: A Pilot Study","primary_completion_date":"2015-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-12-31","last_update":"2018-10-26","description":"A multi-centre, randomized, placebo controlled, trial. Participants at high-risk for vascular events from the network of INTER- CHF will be randomized to inactivated influenza vaccine or placebo and followed prospectively over three influenza seasons. 600 participants will be enrolled prior to influenza season and randomized to either influenza vaccine or saline placebo.","other_id":"RCT IVVE Pilot","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age  18 years and NYHA functional class II, III and IV\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Anaphylactic reaction to a previous dose of TIV\r\n\r\n          -  Known IgE-mediated hypersensitivity to eggs manifested as hives, swelling of the mouth\r\n             and throat, difficulty in breathing, hypotension, or shock\r\n\r\n          -  Guillain-Barr syndrome within eight weeks of a previous influenza vaccine\r\n\r\n          -  Anaphylactic reaction to neomycin\r\n\r\n          -  Patients who have had influenza vaccine in two of the three previous years\r\n      ","sponsor":"McMaster University","sponsor_type":"Other","conditions":"Heart Failure","interventions":[{"intervention_type":"Drug","name":"Drug: inactivated trivalent influenza vaccine","description":"0.5 ml dose injected intramuscularly"},{"intervention_type":"Other","name":"Other: Sterile saline","description":"0.5 ml dose injected intramuscularly"}],"outcomes":[{"outcome_type":"primary","measure":"Feasibility","time_frame":"Six months","description":"If no more than 5% of all recruited subjects crossed over from one study group to the other, and if there is at least 98% follow up."},{"outcome_type":"secondary","measure":"Adverse cardiovascular event","time_frame":"Six months","description":"The primary outcome will be a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalizations for heart failure using standardized criteria."},{"outcome_type":"secondary","measure":"Cardiovascular death","time_frame":"Six months","description":"CV death alone will be a secondary outcome."}]}
{"nct_id":"NCT02413333","start_date":"2015-04-30","phase":"N/A","enrollment":133,"brief_title":"Clear Care Plus vs. PeroxiClear","official_title":"Comparison of Two One-Step Hydrogen Peroxide Lens Care Solutions in Symptomatic Contact Lens Wearers","primary_completion_date":"2015-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-08-31","last_update":"2016-09-19","description":"The purpose of this study is to evaluate Clear Care Plus compared to PeroxiClear for mean residual peroxide in used lens cases collected at Day 30 after neutralization at recommended storage time.","other_id":"LCD913-P001","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Supportive Care","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Sign informed consent form;\r\n\r\n          -  Adapted, 2-week/monthly replacement silicone hydrogel contact lens wearers (at least 2\r\n             months);\r\n\r\n          -  Willing to wear study lenses daily wear only on a daily basis (7 days per week and at\r\n             least 4 hours per day) and attend all study visits;\r\n\r\n          -  Symptoms of contact lens related dryness as defined by the Symptomatic Pre-Screening\r\n             Questionnaire;\r\n\r\n          -  Other protocol-specified inclusion criteria may apply.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Current hydrogen peroxide-based solution user;\r\n\r\n          -  Routinely sleeps in lenses at least 1 night per week over the last 3 months prior to\r\n             enrollment;\r\n\r\n          -  Ocular anterior segment infection, inflammation, abnormality, or active disease that\r\n             would contraindicate contact lens wear;\r\n\r\n          -  Any systemic diseases that may affect the eye or be exacerbated by use of contact\r\n             lenses or contact lens solutions or which could prevent wearing lenses at least 4\r\n             hours per day;\r\n\r\n          -  Use of systemic or ocular medications for which contact lens wear could be\r\n             contraindicated;\r\n\r\n          -  Monocular (only 1 eye with functional vision) or fit with only 1 lens;\r\n\r\n          -  History of herpetic keratitis, ocular surgery, or irregular cornea;\r\n\r\n          -  Other protocol-specified exclusion criteria may apply.\r\n      ","sponsor":"Alcon Research","sponsor_type":"Industry","conditions":"Refractive Error","interventions":[{"intervention_type":"Device","name":"Device: Clear Care Plus contact lens solution","description":"3% hydrogen peroxide solution with Hydraglyde Moisture Matrix for cleaning, disinfection and overnight storage of contact lenses"},{"intervention_type":"Device","name":"Device: PeroxiClear contact lens solution","description":"3% hydrogen peroxide solution for cleaning, disinfection and overnight storage of contact lenses"},{"intervention_type":"Device","name":"Device: Silicone hydrogel contact lenses","description":"2-week/monthly replacement contact lenses per participant's habitual brand"}],"outcomes":[{"outcome_type":"primary","measure":"Mean Residual Peroxide at Day 30","time_frame":"Day 30, each product","description":"The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Residual peroxide was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear)."},{"outcome_type":"secondary","measure":"Mean Osmolality in Lens Cases at Day 30","time_frame":"Day 30, each product","description":"The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Osmolality was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear)."}]}
{"nct_id":"NCT02432989","start_date":"2015-04-30","phase":"N/A","enrollment":20,"brief_title":"Establishing Early Exercise Interventions in Concussion Recovery","official_title":"Rest vs. Early Return to Exercise Following Concussion (H15-00307)","primary_completion_date":"2018-12-31","study_type":"Interventional","rec_status":"Suspended","completion_date":"2018-12-31","last_update":"2018-05-01","description":"This is a Phase 1 study to determine (1) the safety of an exercise protocol in adolescents and young adults with concussion in the first week post-injury and (2) to evaluate the effects of mild symptoms on brain function using EEG. This pilot study will inform subsequent grant applications, and a Phase II randomized control trial that will explore the influence of age on an early re-introduction to exercise, as well as the influence of varying intensity levels of exercise.","other_id":"H15-00307","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":15,"maximum_age":25,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Enrolled in participating minor sports association in the Greater Vancouver Area\r\n\r\n          -  Sustained a recent sports related concussion (within 48 hours of contacting the\r\n             research coordinators)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Less than 15 years of age or over 25 years old.\r\n\r\n          -  Diagnosis of concurrent learning disability, ADHD, Autism or Seizure.\r\n      ","sponsor":"University of British Columbia","sponsor_type":"Other","conditions":"Brain Concussion","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Exercise","description":"Light-moderate exercise on a stationary bike and leisurely walks."}],"outcomes":[{"outcome_type":"primary","measure":"Change in EEG Functional Connectivity Using Graph Theoretical Modeling","time_frame":"Within 48 hours of concussion, and 7 days post-injury","description":"Compare 5 minute resting state electroencephalogram (EEG) between rest and exercise groups. We will record the electrical activity (in Hertz) and compare values using Graph Theoretical measures that establish both global and local connectivity. We will look at the changes in composite measures of betweenness, global efficiency, clustering coefficient, and hub value."},{"outcome_type":"secondary","measure":"Change in Subjective Symptom Reporting","time_frame":"Days 1,2,3,4,5,6 through 7 inclusive post-injury","description":"Compare changes in daily cognitive and physical symptoms between the rest and exercise groups. Symptoms are rated on a 7 point Likert Scale."},{"outcome_type":"secondary","measure":"Differences in Activity Levels","time_frame":"Days 1,2,3,4,5,6 through 7 inclusive post-injury","description":"Compare differences in activity levels between the rest and exercise groups. Activity levels are recorded by an accelerometer and will be compared to participant journal entries."}]}
{"nct_id":"NCT02327130","start_date":"2015-04-30","phase":"N/A","enrollment":32,"brief_title":"Changes in Exhaled 13CO2/12CO2 Breath Delta Value as an Early Indicator of Infection in ICU Patients","official_title":"Changes in Exhaled 13CO2/12CO2 Breath Delta Value as an Early Indicator of Infection in ICU Patients","primary_completion_date":"2017-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-12-31","last_update":"2019-01-03","description":"Carbon-12 and carbon-13 are naturally-abundant isotopes in exhaled breath carbon dioxide. The ratio of carbon-13 to carbon-12 in exhaled breath is known as the breath delta value (BDV). This study is seeking to determine if the breath delta value of critically ill adults is an early indicator of the onset of infection that may lead to sepsis.","other_id":"Canary01","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. age 18 years or older\r\n\r\n          2. critically ill patient admitted to trauma or surgical ICU\r\n\r\n          3. expected duration of hospital stay at least 120 hours (five days) from time of study\r\n             enrollment\r\n\r\n          4. subject/LAR speaks a language of which the IRB has approved a consent form\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. known infection at the time of enrollment per infection definitions in section 6.2\r\n\r\n          2. known use of systemic antibiotic, antimicrobial and/or antifungal therapy within the\r\n             last 7 days (See Antibiotic Use section below)\r\n\r\n          3. prolonged antibiotic or antimicrobial use during the perioperative period (See\r\n             Antibiotic Use section below)\r\n\r\n          4. currently active cancer, or receiving treatment for cancer (including but not limited\r\n             to: radiation, chemotherapy, systemic orals, etc)\r\n\r\n          5. receiving high frequency ventilatory support\r\n\r\n          6. if not intubated, unable to cooperate with providing a breath sample\r\n\r\n          7. expected death within 24 hours of enrollment or lack of commitment to aggressive\r\n             treatment by family/medical team (e.g., likely to withdraw life support measures\r\n             within 24 hrs of screening)\r\n\r\n          8. female who is pregnant or lactating (negative serum or urine pregnancy test results\r\n             within 48 hours of enrollment or to be performed during screening)\r\n\r\n          9. prisoner\r\n\r\n         10. known participation in an interventional research study within 30 days prior to\r\n             enrollment (note: to be eligible, any interventional treatment must have ended at\r\n             least 30 days ago)\r\n\r\n         11. Individuals who are directly affiliated with sponsor or study staff, or their\r\n             immediate families. Immediate family is defined as spouse, domestic partner, parent,\r\n             child, or sibling whether legally adopted or biological.\r\n\r\n         12. Any patient that is deemed unfit for study participation, per the Investigator's\r\n             discretion.\r\n      ","sponsor":"Isomark, LLC","sponsor_type":"Industry","conditions":"Sepsis","interventions":[{"intervention_type":"Device","name":"Device: Isomark Canary","description":"Isomark, LLC is a Madison, Wisconsin-based company that has developed an investigational device, the Isomark Canary, that is intended to determine the breath delta value of breath samples collected from critically ill patients."}],"outcomes":[{"outcome_type":"primary","measure":"Change in Breath Delta Value","time_frame":"Baseline to ICU discharge or 7 days, whichever came first","description":"The variation in breath delta value was assessed regardless of infection status. Exhaled breath samples were collected from participants upon enrollment and every four hours thereafter until the end of the subject's study duration per protocol. Each subject was used as its own control for the purpose of trend analysis.The first breath sample collected was considered an individual's \"baseline\" sample. The change in the breath delta value was calculated from this baseline sample."},{"outcome_type":"secondary","measure":"Number of Participants With an Infection Diagnosis","time_frame":"Days 1 through 7","description":"Daily analysis infection status from blood samples given from each participant."},{"outcome_type":"other","measure":"Positive and Negative Predictive Value of BDV for Infection Diagnosis","time_frame":"7 days","description":"Based on an ROC analysis the optimal cutoff value for indicating the presence of infection using the BDV is 1.4‰.\r\nBased on this cutoff value the sensitivity and specificity were calculated. Sensitivity, or the true positive rate, is the proportion of actual positives that are correctly identified. In this case, the sensitivity is the percentage of people who have an infection and were identified by the Isomark Canary as having an 'infection'.\r\nThe specificity, or the true negative rate, is the promotion of actual negatives that are correctly identified as negative. In this case, the specificity is the proportion of people without infections that were correctly classified by the Isomark Canary as having 'no infection'."}]}
{"nct_id":"NCT02360202","start_date":"2015-04-30","phase":"Phase 4","enrollment":35,"brief_title":"Evaluation of Fluid Retention Due to Superpotent Topical Corticosteroid","official_title":"Evaluation of Fluid Retention Due to Superpotent Topical Corticosteroid in Patients With Bullous Pemphigoid","primary_completion_date":"2017-11-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2017-12-31","last_update":"2017-08-30","description":"Clinical observation frequently shows a paradoxical effect of topical corticosteroids in charge of a sudden melting of edema in the first days of treatment, which could be due to mobilization of extracellular. No study has shown the value of this measure in patients treated with topical steroids. This uncertainty, coupled with the observation of the paradoxical effects of topical steroids on edema are some patients that despite the systemic absorption of clobetasol propionate, a salt-free diet is not currently recommended practice.","other_id":"2014/110/HP","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patient with age higher than 18\r\n\r\n          -  Patient with bullous pemphigoid,\r\n\r\n          -  Patient treated by local corticosteroid therapy (clobetasol propionate cream) but not\r\n             yet processed or for less than 48 hours,\r\n\r\n          -  Signed informed consent.\r\n\r\n          -  Patient affiliated to Social Security Regimen\r\n\r\n          -  Effective contraception in women of childbearing age (for postmenopausal women,\r\n             confirmatory diagnosis of menopause will be collected)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Concomitant treatment with corticosteroids\r\n\r\n          -  Recent introduction or recent (<6 weeks) treatment with diuretics,\r\n             angiotensin-converting enzyme, receptor antagonist or anti-angiotensin renin\r\n             (aliskiren)\r\n\r\n          -  contraindication to the use of Clobetasol propionate (DERMOVAL and CLARELUX)\r\n\r\n          -  Patient on salt diet (<or = to 5 g / d)\r\n\r\n          -  Patients carry a defibrillator or a pace maker\r\n\r\n          -  Amputated Patient\r\n\r\n          -  Pregnant and lactating\r\n\r\n          -  Patient with Urinary Incontinency\r\n\r\n          -  Recent heart decompensation in the last 6 weeks\r\n\r\n          -  known Nephrotic Syndrome\r\n\r\n          -  known or Severe hepatic impairment\r\n\r\n          -  Hypoalbuminaemia less than 20 g / l\r\n      ","sponsor":"University Hospital, Rouen","sponsor_type":"Other","conditions":"Bullous Pemphigoid","interventions":[{"intervention_type":"Procedure","name":"Procedure: Impedance analysis","description":"Impedance analysis in patient with Bullous pemphigoid disease treated with clobetasol propionate.\r\nimpedance analysis includes : fat measures, lean body mass, total body water, extracellular water phase angle"},{"intervention_type":"Drug","name":"Drug: Clobetasol Propionate cream treatment","description":"clobetasol propionate treatment initiated following French recommendations"}],"outcomes":[{"outcome_type":"primary","measure":"Change from Baseline in fluid retention at day 30","time_frame":"Day 30","description":"Change from Baseline in extra-cellular water volume at day 30 measured by bioimpedance analysis"},{"outcome_type":"secondary","measure":"Change from Baseline in fluid retention at day 7","time_frame":"Day 7","description":"Change from Baseline in extra-cellular water volume at day 7 measured by bioimpedance analysis"},{"outcome_type":"secondary","measure":"Weight variation between day 1 and day 30","time_frame":"Day 30"},{"outcome_type":"secondary","measure":"Urinary Sodium level variation between day 1 and day 30","time_frame":"Day 30"},{"outcome_type":"secondary","measure":"Urinary creatinin level variation between day 1 and day 30","time_frame":"Day 30"},{"outcome_type":"secondary","measure":"Brain Natriuretic Peptide level variation between day 1 and day 30","time_frame":"Day 30"},{"outcome_type":"secondary","measure":"Change from Baseline in nutritional parameters at day 30","time_frame":"Day 30","description":"bioimpedance analysis, C Reactive Protein level, albumin level, daily diet diary, Buzby index"},{"outcome_type":"secondary","measure":"Change from Baseline in bullous pemphigoid disease severity index at day 30","time_frame":"Day 30","description":"BPDAI questionary assessment"},{"outcome_type":"secondary","measure":"Change from Baseline in bullous pemphigoid disease severity index at day 7","time_frame":"Day 7","description":"BPDAI questionary assessment"},{"outcome_type":"secondary","measure":"Change from Baseline in corticoid administration dosage at days 30","time_frame":"Day 30","description":"Evaluation of corticoid dosage between day 1 and day 30"}]}
{"nct_id":"NCT02623088","start_date":"2015-04-30","enrollment":107,"brief_title":"CPAP Effect on Vascular Function in Obstructive Sleep Apnea","official_title":"Long Term Effects of Positive Airway Pressure Therapies on Vascular Function in Obstructive Sleep Apnea","primary_completion_date":"2016-03-31","study_type":"Observational","rec_status":"Completed","completion_date":"2016-03-31","last_update":"2016-08-31","description":"Obstructive sleep apnea syndrome is responsible of endothelial dysfunction, which is a independent cardio-vascular risk factor. Assessment of pulse wave velocity (PWV) and peripheral arterial tone (PAT) are study measurements of arterial stiffness, and are strong predictors of late cardiovascular events. This study will compare long term evolution in arterial stiffness (PWV) and endothelial dysfunction (PAT) for patients treated by Positive Airway Pressure Therapies.","other_id":"38RC14.422","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":20,"maximum_age":75,"population":"Patients with sleep apnea syndrome treated by CPAP after diagnosis and followed 5-7 years,\r\n        as part of a clinical research.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Any patient with a initial visit there is 4-7 years for the VNI-SOH protocol (Rf CPP\r\n             Sud-Est V: 38/2006/2)\r\n\r\n          -  Male or female patient, aged 20-75 years at the initial visit there is 4 to 7 years;\r\n\r\n          -  Patients with a BMI> 30kg / m2 at diagnostic;\r\n\r\n          -  Patient affiliated to a social security;\r\n\r\n          -  Having given its written consent to participate in the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Person private of liberty by judicial or administrative decision, person under legal\r\n             protection measure (pregnant or nursing, patient under guardianship) Article L1121-8\r\n\r\n          -  Exclusion period for further studies\r\n\r\n          -  Patient died or lost sight since the initial visit there 4-7 years\r\n      ","sponsor":"University Hospital, Grenoble","sponsor_type":"Other","conditions":"Obstructive Sleep Apnea","interventions":[{"intervention_type":"Other","name":"Other: PAP Therapies (CPAP)","description":"Patients with sleep apnea syndrome treated by PAP Therapies (CPAP) after diagnosis and followed 5-7 years."}],"outcomes":[{"outcome_type":"primary","measure":"Long term evolution in arterial stiffness by pulse wave velocity","time_frame":"4 to 7 years from baseline assessment"},{"outcome_type":"secondary","measure":"Endothelial dysfunction by peripheral arterial tone","time_frame":"4 to 7 years from baseline assessment"},{"outcome_type":"secondary","measure":"Parameters of systemic inflammation : CRP us, TNF-α, IL-6 , Leptin in blood sampling","time_frame":"4 to 7 years from baseline assessment"},{"outcome_type":"secondary","measure":"Parameters of insulin resistance : glycated hemoglobin (HbA1C), blood sugar, insulin","time_frame":"4 to 7 years from baseline assessment"}]}
{"nct_id":"NCT02297347","start_date":"2015-04-30","enrollment":10,"brief_title":"The Brain and Neuropsychological Functioning in Adults With Sapropterin Dihydrochloride Treated Phenylketonuria","official_title":"The Brain, Neurological Features and Neuropsychological Functioning in Adults With Sapropterin Dihydrochloride Treated Phenylketonuria","primary_completion_date":"2017-04-30","study_type":"Observational","rec_status":"Completed","completion_date":"2017-04-30","last_update":"2018-02-05","description":"Newborn screening and early treatment prevent the most severe manifestations of phenylketonuria (PKU). However, executive functioning deficits, attention deficit disorder, slow processing speed, and visual-motor problems commonly occur. Many adults with this disorder also suffer depression and anxiety. In this study the investigators will examine adults with PKU on sapropterin dihydrochloride (Kuvan) treatment for PKU and compare their results to those of subjects with PKU not on Kuvan. Using magnetic resonance imaging (MRI) techniques, including novel MR spectroscopy (MRS) the investigators hope to discover why this distinct constellation of deficits occurs in PKU. Adult subjects with PKU will undergo a comprehensive MRI evaluations, including a novel method of MR spectroscopy to determine brain phenylalanine levels. In addition, participants will receive neurological and neuropsychological examinations and dietary evaluation.","other_id":"IRB-P00015326","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":55,"population":"Adults with PKU on Kuvan treatment for at least one month prior to enrolling in the study.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adult with classic PKU currently on Kuvan treatment for at least one month.\r\n\r\n          -  Age 18-55 years\r\n\r\n          -  Medical Records available that include blood phenylalanine levels during the first 6\r\n             years of life.\r\n\r\n          -  Capable of providing informed consent\r\n\r\n          -  Able to undergo MRI procedures without sedating medication\r\n\r\n          -  Does not have metal implants, braces, or permanent retainers.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Mild PKU or mild hyperphenylalaninemia\r\n\r\n          -  Less than 18 years old or greater than 55 years old\r\n\r\n          -  No medical records available for the first 6 years of life\r\n\r\n          -  Not capable of providing informed consent\r\n\r\n          -  Not able to undergo MRI without sedating medication\r\n\r\n          -  Has metal implants, braces or permanent retainers\r\n\r\n          -  Currently involved in any clinical trial\r\n      ","sponsor":"Boston Children's Hospital","sponsor_type":"Other","conditions":"Phenylketonuria","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Phenylalanine (phe) level in the brain as determined by MR Spectroscopy","time_frame":"one day","description":"Brain phe described as umol/L through MR Spectroscopy in both the , posterior cingulate gyrus (PCG) and parietal white matter (PWM)"},{"outcome_type":"secondary","measure":"Full Scale IQ","time_frame":"one day","description":"Full Scale IQ is obtained from the Wechsler Abbreviated Scale of Intelligence"},{"outcome_type":"secondary","measure":"Brain tyrosine (tyr) level as determined by MR Spectroscopy","time_frame":"one day","description":"Brain tyr described as umol/L through MR Spectroscopy in both the , posterior cingulate gyrus (PCG) and parietal white matter (PWM)"}]}
{"nct_id":"NCT02429284","start_date":"2015-04-30","enrollment":754,"brief_title":"U.S. CTEPH Registry","official_title":"United States CTEPH Registry","primary_completion_date":"2019-05-31","study_type":"Observational [Patient Registry]","rec_status":"Completed","completion_date":"2019-11-30","last_update":"2020-03-24","description":"The U.S. CTEPH Registry is a multicenter, observational, U.S.-based study of the clinical course and treatment of patients diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH), WHO Group IV Classification for Pulmonary Hypertension. The mission of the Registry will be to promote a greater understanding of the prevalence, pathophysiology, evaluation, and treatment of patients with CTEPH through shared information, education, and collaborative investigation among pulmonary hypertension (PH) centers of excellence throughout the U.S.","other_id":"PH-2013-008","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","population":"All consecutive consenting patients recently diagnosed (< 6 months) with CTEPH at\r\n        participating study sites will be enrolled. Patients must meet inclusion criteria and have\r\n        the diagnosis of CTEPH confirmed by the Adjudication Committee (AC) to be enrolled. Adult\r\n        and pediatric patients may be enrolled and prior medical therapy will not exclude patients\r\n        from enrollment.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients must be a permanent resident of the United States\r\n\r\n          -  Documentation of the following hemodynamic parameters by right heart catheterization\r\n\r\n               -  Mean pulmonary arterial pressure (PAPm)  25 mm Hg at rest and,\r\n\r\n               -  Pulmonary artery wedge pressure (PAWP)  15 mm Hg (or > 15 mmHg if justified)\r\n\r\n          -  Radiologic confirmation that chronic thromboembolic disease is the cause of the\r\n             pulmonary hypertension by\r\n\r\n               -  One or more mismatched perfusion defect(s) by lung ventilation/perfusion scan,\r\n                  and\r\n\r\n               -  Confirmation of chronic thromboembolic disease by evidence of bands/webs, vessel\r\n                  narrowing or occlusion seen on CT pulmonary angiogram (CTA), conventional\r\n                  angiography or MR angiography (MRA).\r\n\r\n          -  Patients must be diagnosed with CTEPH within 6 months of being considered for study\r\n             eligibility (signing of consent to participate). The date of diagnosis will be defined\r\n             as when both hemodynamic criteria have been met and chronic thromboembolic disease is\r\n             confirmed to be the cause of the pulmonary hypertension by an abnormal V/Q scan and\r\n             the presence of chronic thromboembolic disease on CTA, MRA or pulmonary angiography.\r\n             Hemodynamic and radiologic criteria can be met at separate time points; the most\r\n             recently met criteria time point will be defined as the date of diagnosis.\r\n\r\n          -  Prior to enrollment all subjects must have the diagnosis of CTEPH confirmed by the\r\n             Adjudication Committee.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients unwilling or unable to provide written consent for participation in the\r\n             study. Appropriate surrogate consent will be obtained for pediatric patients as\r\n             defined by each investigational site's IRB.\r\n\r\n          -  Patients with an underlying medical disorder with an anticipated life expectancy less\r\n             than 2 years.\r\n\r\n          -  Patients who do not meet inclusion criteria including:\r\n\r\n               -  Have not had documentation of hemodynamic criteria by right heart catheterization\r\n                  as outlined in the inclusion criteria\r\n\r\n               -  Do not have radiologic confirmation of chronic thromboembolic disease as outlined\r\n                  in the inclusion criteria\r\n\r\n               -  Meet the criteria for inclusion into WHO Groups I, II, III, or V\r\n      ","sponsor":"University of California, San Diego","sponsor_type":"Other","conditions":"Chronic Thromboembolic Pulmonary Hypertension (CTEPH)|Pulmonary Hypertension","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Describe the patters of risk factors and clinical presentation of CTEPH Patients","time_frame":"up to 5 years"},{"outcome_type":"primary","measure":"Describe the patterns of evaluation of CTEPH Patients","time_frame":"up to 5 years"},{"outcome_type":"primary","measure":"Outcomes of medical and surgical therapy of CTEPH patients as assessed by hemodynamics, quality of life, and functional status","time_frame":"up to 5 years, at 6 month intervals"}]}
{"nct_id":"NCT02394639","start_date":"2015-04-30","phase":"N/A","enrollment":0,"brief_title":"EEG@HOME (Phase 4 of the Project)","primary_completion_date":"2016-08-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2016-09-30","last_update":"2017-11-28","description":"The goal of this project is the development of an EEG-cap (min. 21 electrodes) with user-friendly active dry electrodes that meets the expectations of the users regarding comfort and esthetics, without losing sight of the functional and technical demands for recording high quality EEG signals. The purpose is to use the EEG-cap to investigate clinical neurological disorders (e.g. epilepsy). The EEG-cap could also be used at home so that hospital admission in the EMU can be avoided for some patients and an increasing number of patients can be examined. In this stage of the project video-EEG recording with the prototype will be compared to the conventional way (cup-electrodes and collodion) of recording in the EMU. Minimum 1 - maximum 10 patients with prominent IEDs will be included. After the conventional recording is completed, the patient will undergo a recording of maximum 5 hours with the prototype. There will be an visual and clinical evaluation of the EEG-signals (blinded) and a technical evaluation of the EEG-signals. User experience and experience of the EEG-technologists will also be collected.","other_id":"EC/2015/0140","allocation":"Non-Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Diagnostic","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":4,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Epilepsy with on EEG prominent IEDs\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  /\r\n      ","sponsor":"University Hospital, Ghent","sponsor_type":"Other","conditions":"Epilepsy","interventions":[{"intervention_type":"Other","name":"Other: video-EEG monitoring"}],"outcomes":[{"outcome_type":"primary","measure":"EEG signal quality (visual and clinical) (scale)","time_frame":"5 hours"},{"outcome_type":"primary","measure":"EEG signal quality (technical) (signal to noise ratio)","time_frame":"5 hours"},{"outcome_type":"primary","measure":"User experience (questionnaire)","time_frame":"5 hours"},{"outcome_type":"secondary","measure":"EEG-technologist experience (questionnaire)","time_frame":"5 hours"}]}
{"nct_id":"NCT02349412","start_date":"2015-04-30","phase":"Phase 3","enrollment":405,"brief_title":"Early Palliative Care With Standard Care or Standard Care Alone in Improving Quality of Life of Patients With Incurable Lung or Non-colorectal Gastrointestinal Cancer and Their Family Caregivers","official_title":"Randomized Study of Early Palliative Care Integrated With Standard Oncology Care Versus Standard Oncology Care Alone in Patients With Incurable Lung or Non-Colorectal Gastrointestinal Malignancies","primary_completion_date":"2017-07-03","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-07-15","last_update":"2021-07-26","description":"The study intervention consists of the early integration of palliative care services into standard oncology care in an outpatient setting for patients with advanced lung and non-colorectal gastrointestinal malignancies who are not being treated with curative intent. The palliative care services provided to patients randomized to the intervention will be provided by board-certified physicians and/or advanced practice nurses and will focus on the following areas: (1) developing and maintaining the therapeutic relationship with the patients and family caregivers; (2) assessing and treating patient symptoms; (3) providing support and reinforcement of coping with advanced cancer in patients and family caregivers; (4) assessing and enhancing prognostic awareness and illness understanding in patients and family caregivers; (5) assisting with treatment decision-making; and (6) end-of-life care planning.","other_id":"A221303","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Study Patient Participant Eligibility Requirements:\r\n\r\n          1. Documentation of Disease: Confirmed advanced lung cancer (NSCLC, small cell lung\r\n             cancer, or mesothelioma) or non-colorectal GI cancer (esophageal, gastric, hepatic,\r\n             biliary, or pancreatic) not being treated with curative intent.\r\n\r\n          2. Informed of diagnosis of incurable disease within the previous 8 weeks.\r\n\r\n          3. Age  18 years\r\n\r\n          4. ECOG Performance Status 0-2\r\n\r\n          5. Ability to read and respond to questions in English or able to complete questions with\r\n             minimal assistance required from an interpreter or family member.\r\n\r\n          6. Planning to receive all medical care for cancer at the enrolling institution.\r\n\r\n          7. Participants must be under the care of an oncologist, but their current plan may or\r\n             may not include chemotherapy or other forms of tumor-directed therapies.\r\n\r\n        Study Family Caregiver Participant Eligibility Requirements:\r\n\r\n          1. Relative or friend who is identified by the patient participant who plans to regularly\r\n             accompany the patient to the majority of their clinic visits.\r\n\r\n          2. Family caregiver must live with the patient or have in-person contact with him or her\r\n             at least twice per week.\r\n\r\n          3. Ability to read and respond to questions in English or able to complete questions with\r\n             minimal assistance required from an interpreter or family member.\r\n\r\n          4. Age  18 years\r\n\r\n        Note: An eligible patient may participate in this trial without an eligible family\r\n        caregiver being registered.\r\n      ","sponsor":"Alliance for Clinical Trials in Oncology","sponsor_type":"Other","conditions":"Liver Cancer|Anxiety Disorder|Depression|Small Cell Lung Cancer|Extrahepatic Bile Duct Cancer|Malignant Mesothelioma|Pancreatic Cancer|Esophageal Cancer|Gastric Cancer|Non-small Cell Lung Cancer","interventions":[{"intervention_type":"Other","name":"Other: Early palliative care"}],"outcomes":[{"outcome_type":"primary","measure":"Change in Quality of Life (QOL) From Baseline to Week 12 Per the Functional Assessment of Cancer Therapy-General (FACT-G)","time_frame":"Up to 12 weeks","description":"Quality of Life (QOL) was measured using the Functional Assessment of Cancer Therapy-General (FACT-G) on a 0-108 scale, with lower scores corresponding to worse overall QOL and higher scores corresponding to better overall QOL. Change from baseline to week-12 was calculated by subtracting the baseline scores from the scores at week-12. Higher scores on FACT-G indicate better QOL."},{"outcome_type":"secondary","measure":"Change in Quality of Life (QOL) From Baseline to Week 24 Per the Functional Assessment of Cancer Therapy-General (FACT-G)","time_frame":"Up to 24 weeks","description":"Quality of Life (QOL) was measured using the Functional Assessment of Cancer Therapy-General (FACT-G) on a 0-108 scale, with lower scores corresponding to worse overall QOL and higher scores corresponding to better overall QOL. Change from baseline to week-24 was calculated by subtracting the baseline scores from the scores at week-24. Higher scores on FACT-G indicate better QOL."},{"outcome_type":"secondary","measure":"Change in Quality of Life (QOL) From Baseline to Week 12 Per the Hospital Anxiety and Depression Scale (HADS) - Depression","time_frame":"Up to 12 weeks","description":"Quality of Life (QOL) was measured using the Hospital Anxiety and Depression Scale (HADS) - Depression on a 0-21 scale, with lower scores corresponding to lower depression and higher scores corresponding to higher depression. Change from baseline to week-12 was calculated by subtracting the baseline scores from the scores at week-12. Lower scores on the HADS-Depression indicate less depression symptoms."},{"outcome_type":"secondary","measure":"Change in Quality of Life (QOL) From Baseline to Week 12 Per the Hospital Anxiety and Depression Scale (HADS) - Anxiety","time_frame":"Up to 12 weeks","description":"Quality of Life (QOL) was measured using the Hospital Anxiety and Depression Scale (HADS) - Anxiety on a 0-21 scale, with lower scores corresponding to lower anxiety and higher scores corresponding to higher anxiety. Change from baseline to week-12 was calculated by subtracting the baseline scores from the scores at week-12. Lower scores on the HADS-Anxiety indicate less anxiety symptoms."},{"outcome_type":"secondary","measure":"Prognostic Understanding at Week-12 as Measured by \"Have You and Your Oncologist Discussed Any Particular Wishes About the Care You Would Want to Receive if You Were Dying?\" Question on the Prognosis and Treatment Perceptions Questionnaire","time_frame":"Up to 12 weeks","description":"Prognostic Understanding at Week-12 as measured by Prognosis and Treatment Perceptions Questionnaire: \"Have you and your oncologist discussed any particular wishes about the care you would want to receive if you were dying?\" responses at Week-12 are reported below."},{"outcome_type":"secondary","measure":"Change in QOL on the SF-36 Over Time","time_frame":"Up to 3 years"},{"outcome_type":"secondary","measure":"Rate of Referral, Enrollment and Length of Stay on Hospice","time_frame":"Up to 3 years"},{"outcome_type":"secondary","measure":"Location of Death","time_frame":"Up to 3 years"},{"outcome_type":"secondary","measure":"Number of Hospital and Intensive Care Unit (ICU) Admissions and Days","time_frame":"Up to 3 years"},{"outcome_type":"secondary","measure":"Chemotherapy and Radiation Administration","time_frame":"Up to 3 years"},{"outcome_type":"secondary","measure":"Overall Survival","time_frame":"Up to 3 years"},{"outcome_type":"secondary","measure":"Concordance Between Patient and Family Caregiver Report of Prognosis/Curability","time_frame":"Up to 3 years"}]}
{"nct_id":"NCT02414204","start_date":"2015-04-30","phase":"N/A","enrollment":4,"brief_title":"Phosphodiesterase Type 5 Inhibition to Improve Endothelial Function and Vascular Remodeling in Chronic Kidney Disease and End Stage Renal Disease Patients Requiring New Arteriovenous Fistula","official_title":"Phosphodiesterase Type 5 Inhibition to Improve Endothelial Function and Vascular Remodeling in Chronic Kidney Disease and End Stage Renal Disease Patients Requiring New Arteriovenous Fistula","primary_completion_date":"2017-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-06-30","last_update":"2019-08-12","description":"Patients with stage IV and V chronic kidney disease and end stage renal disease requiring hemodialysis at University of Alabama at Birmingham (UAB) Dialysis Clinics will be recruited from the UAB Vascular Access Clinic, which has been the site for recruitment of patients requiring new vascular access for the last 10 years.","other_id":"F150220002","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":19,"maximum_age":99,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age 19 years of age male or female\r\n\r\n          2. Chronic Kidney Disease Stage IV or V patients or End Stage Renal Disease Patient\r\n             requiring arteriovenous fistula surgery\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patient currently on nitrate therapy or any nitric oxide donor in any form\r\n\r\n          2. Patient currently on protease inhibitor or non-nucleoside reverse transcriptase\r\n             inhibitor\r\n\r\n          3. Patient with resting systolic blood pressure <90 mm Hg and diastolic blood pressure <\r\n             50 mm Hg.\r\n\r\n          4. Patient life expectancy < nine months.\r\n\r\n          5. Patient unable or unwilling to meet study requirements.\r\n      ","sponsor":"University of Alabama at Birmingham","sponsor_type":"Other","conditions":"Improve Endothelial Function and Decrease Vascular Stenosis","interventions":[{"intervention_type":"Drug","name":"Drug: Sildenafil","description":"Sildenafil, a phosphodiesterase 5 inhibitor that enhances the effects of nitric oxide (NO), has been shown in experimental and clinical studies in cardiovascular disease to improve endothelial function and decrease vascular stenosis."},{"intervention_type":"Other","name":"Other: Placebo","description":"Placebo will be over encapsulated to identical to drug comparison"}],"outcomes":[{"outcome_type":"primary","measure":"Change in Baseline and 2 Week FMD/VP Measurements Between Sildenafil Group and Placebo Group","time_frame":"2 weeks","description":"For flow mediated dilation studies (FMD), the brachial artery diameter was measured by ultrasound at baseline. An automated floor pressure cuff was inflated on the upper arm to a suprasystolic pressure that was sustained for 5 minutes, and the brachial diameter measurement was repeated 55-65 seconds after releasing the cuff. FMD was calculated as the percentage change in arterial diameter from baseline.\r\nFor venous occlusion plethysmography studies (VP), forearm volume was measured using a strain-gauge plethysmography device during application of an upper arm BP cuff at increasing but subsystolic pressures. Venous capacitance slope was estimated from the volume-pressure relationship and expressed as a percentage increase in volume per millimeters of mercury.\r\nThe change at baseline and 2 weeks in these measurements between the sildenafil and placebo group will be assessed."},{"outcome_type":"secondary","measure":"Number of Participants With a Change in Blood Flow Rate","time_frame":"6 weeks","description":"Blood flow of the fistula at 6 weeks is measured with doppler ultrasound and values of the fistula artery and vein are obtained (ml/min). The difference in blood flow rates of the fistula artery and vein between the sildenafil treated group and placebo group will be assessed."}]}
{"nct_id":"NCT02735109","start_date":"2015-04-30","phase":"N/A","enrollment":30,"brief_title":"Interest of the Confocal Microscope in the Diagnosis of Epidermoid Carcinoma of the Vulva and Their Precursors","official_title":"Interest of the Confocal Microscope in the Diagnosis of Epidermoid Carcinoma of the Vulva and Their Precursors","primary_completion_date":"2016-04-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2016-04-30","last_update":"2016-04-12","description":"The confocal microscope is a noninvasive imaging technique that provides high-resolution images to a depth of 250 microns, such as \"optical\" cuts in three dimensions in the thickness of the skin. This is a single-center prospective descriptive study at the University Hospital of Nice in gynecology and dermatology. The aim of the study is to describe the characteristics reproducibly for confocal microscope of normal vulvar mucosa lesions VIN, and vulvar squamous carcinoma. The patients seen in consultation with vulvar lesions suspicious looking will be included. The results will be compared systematically to the histological results of biopsies of lesions (gold standard).","other_id":"14-AOI-13","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Screening","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age = 18 years, Female\r\n\r\n          -  Patient seen in consultation in the service of gynecology obstetrics, and, of\r\n             dermatology of the Bow presenting during the medical examination one or several\r\n             suspicious-looking vulvar hurts, suggestive of hurts of VIN or of carcinoma epidermoid\r\n             vulvar\r\n\r\n          -  Membership health secure\r\n\r\n          -  Informed consent and paper of the obtained patient\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patient having already received a local treatment(processing) for hurts of VIN\r\n\r\n          -  Pregnant Woman\r\n\r\n          -  Patient under guardianship\r\n\r\n          -  Not signature of the written consent and/or mental deficiency of the subject making\r\n             its participation on approval impossible\r\n      ","sponsor":"Centre Hospitalier Universitaire de Nice","sponsor_type":"Other","conditions":"Vulvar Mucosa Lesions|Vulvar Intraepithelial Neoplasia","interventions":[{"intervention_type":"Procedure","name":"Procedure: biopsy normal area","description":"biopsy done to compare with abnormal area"},{"intervention_type":"Other","name":"Other: photographies","description":"cells description by taken photographies vith confocal microscope (VivaScope 3000)"}],"outcomes":[{"outcome_type":"primary","measure":"Caracteristics of thorny layer, of granular layer,of basal layer of normal vulvar mucosa lesions VIN, and vulvar squamous cell carcinoma with confocal microscope","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Caracteristics of thorny layer, of granular layer,of basal layer of normal vulvar mucosa lesions VIN, and vulvar squamous cell carcinoma with histological method","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Caracteristics of thorny layer, of granular layer,of basal layer of vulvar mucosa lesions VIN to descriptions and the observations of with the normal mucosa","time_frame":"12 months"}]}
{"nct_id":"NCT02322333","start_date":"2015-03-31","phase":"Phase 2/Phase 3","enrollment":157,"brief_title":"MLD10 in the Prevention of Migraine in Adults","official_title":"A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of MLD10 in the Prevention of Migraine Headache in Adults","primary_completion_date":"2017-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-06-30","last_update":"2020-10-09","description":"This is a double-blind, placebo-controlled, randomized, multi-center study. Subjects agreeing to participate in the study and meet the entry criteria assessed at the screening visit, will begin a 28 day baseline period to confirm their diagnosis, as well as establish baseline migraine characteristics. During this baseline period, subjects will continue treating their migraines as usual, simply recording the information in a daily headache diary. Subjects who, after completing the baseline, continue to meet entrance criteria will be eligible to enter into the treatment phase and be randomized according to the Clinvest generated randomization schedule. Approximately 142 subjects (71 subjects per arm) will be randomized and enter the treatment phase receiving MLD10 or placebo in a 1:1 design at 6 United States sites. Diary assessments will collect study medication adherence, pain severity, headache symptoms, acute medication usage, and unusual symptoms. Serum samples will be collected and analyzed for ionized magnesium, electrolytes, and creatinine.","other_id":"MLD10-002","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. male or female, in otherwise good health, 18 to 65 years of age.\r\n\r\n          2. history of frequent episodic migraine (3-14 migraine days per month) (with or without\r\n             aura) according to the International Classification of Headache Disorders-3beta for at\r\n             least 3 months.\r\n\r\n          3. onset of migraine before age 50.\r\n\r\n          4. stable history of migraine at least 3 months prior to screening.\r\n\r\n          5. not currently taking a migraine preventive or has been taking preventive for at least\r\n             30 days prior to screening and agrees to not start, stop, or change medication and/or\r\n             dosage during the study period.\r\n\r\n          6. if female of childbearing potential, has a negative urine pregnancy test at Visits 1-5\r\n             and uses, or agrees to use, for the duration of the study, a medically acceptable form\r\n             of contraception as listed:\r\n\r\n               -  complete abstinence from intercourse from 2 weeks prior to administration of\r\n                  study drug, throughout the study, and for 7 days after completion or premature\r\n                  discontinuation from the study; surgically sterile (hysterectomy or tubal\r\n                  ligation or otherwise incapable of pregnancy); sterilization of male partner when\r\n                  in a monogamous relationship; intrauterine device with published data showing\r\n                  lowest expected failure rate is less than 1% per year; double barrier method\r\n                  (i.e., 2 physical barriers OR 1 physical barrier plus spermicide) for a least 1\r\n                  month prior to Visit 1 and throughout study; or hormonal contraceptives for at\r\n                  least 3 months prior to Visit 1 and throughout study.\r\n\r\n          7. completion of online diary must be  80% compliance, unless otherwise approved by the\r\n             Sponsor and/or Clinvest.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. unable to understand the study requirements, the informed consent, or complete\r\n             headache records as required per protocol.\r\n\r\n          2. pregnant, actively trying to become pregnant, or breast-feeding.\r\n\r\n          3. diagnosed with International Classification of Headache Disorders-3beta criteria for\r\n             Chronic Migraine within 3 months prior to screening, at the time of screening, and/or\r\n             during the baseline period.\r\n\r\n          4. experienced the following migraine variants: basilar migraine, aura without headache,\r\n             familial hemiplegic migraine, complicated migraine, ophthalmoplegic migraine and\r\n             retinal migraine within the last year.\r\n\r\n          5. history of medication overuse headache (MOH) (Appendix II) in the 3 months prior to\r\n             study enrollment or during the baseline phase.\r\n\r\n          6. history of medication overuse (MO) of ergotamines, triptans, opioids, analgesics,\r\n             NSAIDS and combination therapies, as defined by ICHD-3beta criteria and/or MO during\r\n             baseline period.\r\n\r\n          7. history of substance abuse and/or dependence, in the opinion of the Investigator.\r\n\r\n          8. history of impaired renal function that, in the investigator's opinion,\r\n             contraindicates participation in this study.\r\n\r\n          9. unstable neurological condition or a significantly abnormal neurological examination\r\n             with focal signs or signs of increased intracranial pressure.\r\n\r\n         10. suffers from a serious illness, or an unstable medical condition, one that could\r\n             require hospitalization, or could increase the risk of adverse events.\r\n\r\n         11. has significant risk of suicide, defined as a \"yes\" answer to any of the following\r\n             questions on the Columbia-Suicide Severity Rating Scale (C-SSRS), either at the\r\n             screening visit (when assessing the prior 12 months) or at visit 2 (when assessing\r\n             time since the screening visit):\r\n\r\n               1. Questions 4 or 5 on the suicidal ideation section\r\n\r\n               2. Any question on any item in the suicidal behavior section\r\n\r\n         12. any psychiatric disorder with psychotic features, and/or any other psychiatric\r\n             disorder not stable or well controlled, that would interfere in their ability to\r\n             complete study activities.\r\n\r\n         13. hypersensitivity, intolerance, or contraindication to the use of magnesium L-lactate\r\n             dehydrate or any of its components.\r\n\r\n         14. received any investigational agents within 30 days prior to Visit 1.\r\n\r\n         15. plans to participate in another clinical study at any time during this study.\r\n      ","sponsor":"Pharmalyte Solutions LLC","sponsor_type":"Industry","conditions":"Migraine","interventions":[{"intervention_type":"Drug","name":"Drug: MLD10"},{"intervention_type":"Drug","name":"Drug: Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"Migraine Headache Days","time_frame":"Day 1(Screening) - Day 116 (Visit 5 End of Study)","description":"Comparison of the mean change from baseline in the frequency of migraine headache days per 28-day period ending with the cessation of treatment period month 3 in subjects treated with MLD10 versus placebo.\r\nA migraine headache day will be defined as a calendar day (00:00 to 23:59) with 4 or more hours of migraine headache, fulfilling International Classification of Headache Disorders-3beta criteria, and/or any headache of any duration with the use of migraine-specific acute medications(s) (i.e. ergot alkaloids, ergot combinations, opioids, triptans, combination analgesics [simple analgesics combined with opioids or barbiturate with or without caffeine])."},{"outcome_type":"secondary","measure":"Headache Days","time_frame":"Day 1(Screening) - Day 116 (Visit 5 End of Study)","description":"Comparison of the change from baseline of subjects treated with MLD10 versus placebo in the frequency of headache days during the 3 month treatment period.\r\nA headache day will be defined as any day not classified as a migraine day, but recorded headache of any severity and/or duration."},{"outcome_type":"secondary","measure":"Headache Duration","time_frame":"Day 1(Screening) - Day 116 (Visit 5 End of Study)","description":"Change from baseline (28 day period) in the total cumulative minutes of headache during each 28-day treatment period month 1, 2, & 3 in subjects treated with MLD10 versus placebo.\r\nAll headaches and/or migraines will be including in this outcome analysis."},{"outcome_type":"secondary","measure":"Pain Severity","time_frame":"Day 1(Screening) - Day 116 (Visit 5 End of Study)","description":"Change from baseline (28 day period) in the average pain severity at time of onset compared to each 28-day treatment period month 1, 2, & 3 in subjects treated with MLD10 versus placebo. Headache pain severity was measured on a scale 1 = Mild, 2 = Moderate, 3 = Severe."},{"outcome_type":"secondary","measure":"Acute Medication Usage","time_frame":"Day 1(Screening) - Day 116 (Visit 5 End of Study)","description":"Change from baseline (28 day period) in the total number of acute headache pain medications used during each 28 day treatment period month 1, 2, & 3 in subjects treated with MLD10 versus placebo."},{"outcome_type":"secondary","measure":"Migraine Disability Assessment Scale (MIDAS)","time_frame":"Day 29 (Randomization) & Day 116 (Visit 5 End of Study)","description":"Change from Visit 2 to Visit 5 in the total MIDAS score in subjects treated with MLD10 versus placebo.\r\nThe MIDAS test determines how severely migraines affect daily functioning. The responses of a variety of questions will be scored according to the questionnaire's scoring guide. A total score will be calculated ranging from 0-93. A score of 0-5 indicates little or no disability, 6-10 mild disability, 11-20, moderate disability, 21+ severe disability."},{"outcome_type":"secondary","measure":"Subject Global Impression of Change (SGIC)","time_frame":"Day 116 (Visit 5 End of Study)","description":"Comparison of SGIC at Visit 5 in subjects treated with MLD10 versus placebo.\r\nGlobal impression of change rated by the subject will be assessed using a 7-point Likert scale ranging from -3 to 3 with -3 = very much worse, -2 = much worse, -1 = minimally worse, 0 = no change, 1 = minimally improved, 2 = much improved, 3 = very much improved."},{"outcome_type":"secondary","measure":"Physician Global Impression of Change (PGIC)","time_frame":"Day 116 (Visit 5 End of Study)","description":"Comparison of PGIC at Visit 5 in subjects treated with MLD10 versus placebo.\r\nThe PGIC will be an impression of change rated by the investigator using a 7-point Likert scale ranging from -3 to 3 with -3 = very much worse, -2 = much worse, -1 = minimally worse, 0 = no change, 1 = minimally improved, 2 = much improved, 3 = very much improved."}]}
{"nct_id":"NCT02369471","start_date":"2015-03-31","phase":"Phase 2","enrollment":32,"brief_title":"A Study of GWP42006 in People With Focal Seizures - Part A","official_title":"A Double Blind, Randomized, Placebo-controlled, Two-part Study to Investigate the Pharmacokinetics, Followed by Efficacy and Safety of GWP42006 as add-on Therapy in Patients With Inadequately Controlled Focal Seizures.","primary_completion_date":"2015-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-11-30","last_update":"2016-06-06","description":"To evaluate the pharmacokinetics, safety and tolerability of GWP42006 compared with placebo, in the presence of other antiepileptic drugs (AEDs).","other_id":"GWEP1330 Part A","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        For inclusion in Part A of the study patients must fulfil ALL of the following criteria:\r\n\r\n          -  Male or female aged between 18 and 65 years, inclusive.\r\n\r\n          -  Well-documented history of focal epilepsy, with focal seizures as the primary seizure\r\n             type, compatible electroencephalogram and clinical history.\r\n\r\n          -  Documented computerized tomography / magnetic resonance imaging that shows no\r\n             progressive neurologic abnormality.\r\n\r\n          -  Has focal seizures despite prior treatment with at least two AEDs (whether as\r\n             monotherapies or in combination).\r\n\r\n          -  Currently treated with one to three AEDs as follows:\r\n\r\n               -  Group 1 - subjects on inducer AEDs (and not on inhibitor AEDs)\r\n\r\n               -  Group 2 - subjects on inhibitor AEDs (and no on inducer AEDs)\r\n\r\n               -  Group 3 - subjects on AEDs that are neither inducers nor inhibitors.\r\n\r\n          -  All medications or interventions for epilepsy (including ketogenic diet and any\r\n             neurostimulation devices for epilepsy) must have been stable for two weeks prior to\r\n             screening and the patient is willing to maintain a stable regimen throughout the\r\n             study.\r\n\r\n          -  Subject is willing to keep any factors expected to affect seizures stable (such as the\r\n             level of alcohol consumption and smoking).\r\n\r\n        The patient may not enter Part A of the study if ANY of the following apply:\r\n\r\n          -  Time of onset of epilepsy treatment is less than two years prior to enrolment.\r\n\r\n          -  Episode(s) of status epilepticus during one year prior to screening.\r\n\r\n          -  History of pseudo-seizures.\r\n\r\n          -  Subject has clinically significant unstable medical conditions other than epilepsy.\r\n\r\n          -  Subject has an illness in the four weeks prior to screening or randomization, other\r\n             than epilepsy, which in the opinion of the investigator would affect seizure\r\n             frequency.\r\n\r\n          -  Subject has significantly impaired hepatic function at Visit 1.\r\n\r\n          -  Active suicidal plan/intent in the past six months, or a history of suicide attempt in\r\n             the last two years, or more than one lifetime suicide attempt.\r\n\r\n          -  Subject is currently using or has in the past used recreational or medicinal cannabis,\r\n             or cannabinoid based medications within the three months prior to screening and is\r\n             unwilling to abstain for the duration for the study.\r\n\r\n          -  Subject has taken St John's Wort in the last two weeks and/or is unwilling to abstain\r\n             throughout the study.\r\n\r\n          -  Subject has consumed grapefruit or grapefruit juice three days prior to randomization\r\n             and/or unwilling to abstain in the three days prior to Visits A2 and A4.\r\n\r\n          -  Any known or suspected hypersensitivity to cannabinoids, sesame oil or any of the\r\n             excipients of the IMP(s).\r\n\r\n          -  Subjects who have received an IMP within the 12 weeks prior to the screening visit.\r\n      ","sponsor":"GW Research Ltd","sponsor_type":"Industry","conditions":"Epilepsy|Focal Seizures","interventions":[{"intervention_type":"Drug","name":"Drug: GWP42006"},{"intervention_type":"Drug","name":"Drug: Placebo"}],"outcomes":[{"outcome_type":"secondary","measure":"Safety and tolerability of GWP42006 (incidence of adverse events).","time_frame":"Day -14 to Day 43"},{"outcome_type":"secondary","measure":"The plasma concentration of concomitant AEDs.","time_frame":"Day 1 and Day 15"},{"outcome_type":"primary","measure":"Pharmacokinetic parameters of GWP42006 and metabolites: Cmax, Cmin, tmax, AUC(0-t), AUC(0-inf) and t1/2, in the presence of other AEDs.","time_frame":"Day 1 to Day 18"}]}
{"nct_id":"NCT02368925","start_date":"2015-03-31","phase":"N/A","enrollment":18,"brief_title":"Clinical Trial to Evaluate Safety and Efficacy of Ultherapy System for Lifting Skin on the Neck","official_title":"Clinical Trial to Evaluate Safety and Efficacy of Ultherapy System for Lifting Skin","primary_completion_date":"2015-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-10-31","last_update":"2016-04-15","description":"Study is a prospective clinical trial to evaluate the efficacy of the Ulthera System to improve Lifting Skin on the Neck. Changes from baseline in the FACE-Q Appraisal of Neck scale score and Global Aesthetic Improvement Scale scores will be assessed at study follow-up visits.","other_id":"E-1411/274-002","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":30,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female, aged 30 to 65 years.\r\n\r\n          -  Subject in good health\r\n\r\n          -  Subjects who desire improvement in neck skin\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Presence of an active systemic infectious disease\r\n\r\n          -  general disease or skin disorder in the area to be treated\r\n\r\n          -  Pregnant or lactating subjects\r\n\r\n          -  Previous episode of facial or neck surgery for wrinkle correction\r\n\r\n          -  Subjects who have aesthetic addiction, drug abuse, alcohol abuse\r\n\r\n          -  Subjects who were treated Botox or Filler at the neck area\r\n\r\n          -  Subjects who had Auto-Immune disease\r\n      ","sponsor":"Seoul National University Hospital","sponsor_type":"Other","conditions":"Wrinkles","interventions":[{"intervention_type":"Device","name":"Device: Ultherapy System","description":"The Investigator will apply to the eligible subject the Study Device Ultherapy System with 200~260 lines of 3.0 and 4.5 probe respectively on the subject's neck."}],"outcomes":[{"outcome_type":"primary","measure":"Investigator Assessment of Improvement at 12 weeks post-treatment","time_frame":"12 weeks post-treatment","description":"Investigator complete Global Aesthetic Improvement Scale at 12 weeks post-treatment by comparing subject's photographs"},{"outcome_type":"secondary","measure":"Subject Assessment of Improvement at 12 weeks post-treatment","time_frame":"12 weeks post-treatment","description":"Subjects complete a Patient Assessment Global Aesthetic Improvement Scale at 12 weeks posttreatment"},{"outcome_type":"secondary","measure":"Subjects' Assessment of Pain during treatment","time_frame":"Subjects were assessed for the duration of study treatment","description":"Pain score record using a Numeric Rating Scale (NRS,0-10) , with 0 representing no pain and 10 representing the worst pain possible."}]}
{"nct_id":"NCT02214004","start_date":"2015-03-31","phase":"Phase 2","enrollment":132,"brief_title":"Neoadjuvant Trastuzumab and Letrozole for Postmenopausal Women","official_title":"A Phase II Trial of Preoperative HER2 Targeting and Endocrine Therapy in Postmenopausal Women With HER2 and HR Positive Breast Cancer","primary_completion_date":"2019-03-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-06-30","last_update":"2018-02-15","description":"The purpose of this study is to evaluate whether trastuzumab and letrozole are effective and safe in the preoperative treatment for postmenopausal patients with hormone receptor-positive and HER2-positive breast cancer.","other_id":"HERAKLES","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Invasive cancer (clinical stage IB-IIIC)\r\n\r\n          -  Measurable tumor larger than 1cm\r\n\r\n          -  ECOG status 0 or 1\r\n\r\n          -  Postmenopausal women\r\n\r\n               -  Age 55 years and amenorrhea\r\n\r\n               -  Age <55 years and amenorrhea for 12 months with FSH >30 mIU/ml\r\n\r\n          -  HER2 positive tumor\r\n\r\n               -  3 positive on IHC\r\n\r\n               -  2 positive on IHC with HER2 gene amplification on FISH or SISH using a\r\n                  single-probe or dual-probe\r\n\r\n          -  Estrogen receptor positive tumor\r\n\r\n               -  Positive ER expression with Allred score more than PS3/TS8 or modified Allred\r\n                  score more than PS4/TS7\r\n\r\n          -  Eligible cardiac function\r\n\r\n               -  Normal heard evaluated by ECG\r\n\r\n                    -  Consider clinically non-significant arrythmia and ischemic change as normal\r\n\r\n               -  LVEF  55% measured by ECHO or MUGA scan\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Inflammatory breast cancer\r\n\r\n          -  Bilateral breast cancer\r\n\r\n          -  Patients with previous breast cancer history\r\n\r\n          -  Patients with previous breast cancer treatment: Generally include hormone therapy,\r\n             chemotherapy, and radiotherapy)\r\n\r\n          -  Patients having uncontrolled heart problems\r\n\r\n               -  Ischemic heart disease within 6 months\r\n\r\n               -  Congestive heart failure more than NYHA class II\r\n\r\n               -  Unstable angina\r\n\r\n               -  Clinically significant pericarditis\r\n\r\n               -  Amyloid heart disease\r\n      ","sponsor":"Gangnam Severance Hospital","sponsor_type":"Other","conditions":"Breast Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Trastuzumab","description":"- Eight times IV administration of trastuzumab per 3 weeks\r\nTrastuzumab 8mg/kg on Day 1 of Cycle 1\r\nTrastuzumab 6mg/kg from Day 1 of Cycle 2 to Day 1 of Cycle 8"},{"intervention_type":"Drug","name":"Drug: Letrozole","description":"- Daily letrozole 2.5 mg/day for 24 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"The rate of pathologic complete response","time_frame":"At time of surgery","description":"No residual invasive cancer in breast regardless of axilla"},{"outcome_type":"secondary","measure":"Clinical Response Rate","time_frame":"At time of surgery","description":"Clinical response includes complete response, partial response and stable disease."},{"outcome_type":"secondary","measure":"Safety profiles for the preoperative use of concurrent trastuzumab and letrozole","time_frame":"Up to 3 months after surgery","description":"Toxicity according to CTCAE protocol from the initiated day to 3 months after surgery"},{"outcome_type":"secondary","measure":"The rate of breast conservative surgery","time_frame":"Up to 3 weeks after surgery","description":"The rate of breast conservative surgery among the patients receiving surgery"},{"outcome_type":"secondary","measure":"Total pathologic complete response (tpCR)","time_frame":"At time of surgery","description":"No residual invasive cancer in breast and ipsilateral axilla"},{"outcome_type":"secondary","measure":"Analysis of biomarkers based on baseline specimen and residual tumor","time_frame":"Baseline and at time of surgery","description":"Ki67 expression\r\ncDNA microarray: gene expression profiling"},{"outcome_type":"secondary","measure":"Association between clinical response rate and circulating tumor cells (CTCs)","time_frame":"Baseline and at time of surgery","description":"Association between clinical response rate and circulating tumor cells (CTCs)\r\n: CTCs are measured by CytoGen (SEOUL, KOREA)\""}]}
{"nct_id":"NCT02421601","start_date":"2015-03-31","phase":"Phase 3","enrollment":1011,"brief_title":"A Study of SI-6603 in Patients With Lumbar Disc Herniation","official_title":"A Multicenter, Open-label Study of SI 6603 in Patients With Lumbar Disc Herniation (Phase III)","primary_completion_date":"2018-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-02-28","last_update":"2019-03-27","description":"The purpose of this study is to evaluate the safety and efficacy of SI-6603(Condoliase) in patients with lumbar disc herniation.","other_id":"6603/1132","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":30,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with lumbar disc herniation (L1-L2, L2-L3, L3-L4, L4-L5 or L5-S1) as assessed\r\n             by MRI and clinical symptoms corresponding to position of the impaired nerve root.\r\n\r\n          -  Patients assessed as positive in the Femoral Nerve Stretching (FNS) test for L1-L2,\r\n             L2-L3, or L3-L4 and Straight Leg Raising (SLR) test.\r\n\r\n          -  Patients with sciatica in either leg.\r\n\r\n          -  Patients with no improvement from conservative treatment\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who have 2 or more lumbar disc herniations as assessed by MRI.\r\n\r\n          -  Patients in whom a rupture into the posterior longitudinal ligament is identified by\r\n             MRI.\r\n\r\n          -  Patients who have undergone lumbar operation, or lumbar percutaneous nucleotomy or\r\n             lumbar intradiscal therapies\r\n      ","sponsor":"Seikagaku Corporation","sponsor_type":"Industry","conditions":"Intervertebral Disc Disease|Lumbar Disc Disease","interventions":[{"intervention_type":"Drug","name":"Drug: Condoliase","description":"1.25 U, intradiscal injection, one time"}],"outcomes":[{"outcome_type":"primary","measure":"Evaluate the safety of a single-dose intervertebral disc injection of SI-6603 in patients with lumbar disc herniation.","time_frame":"26 weeks","description":"The occurence of Adverse Events as a measure to evaluate the safety of a single-dose of SI-6603"},{"outcome_type":"secondary","measure":"Leg pain as assessed by a Visual Analog Scale (VAS)","time_frame":"26 weeks","description":"Assessed by a Visual Analog Scale (VAS)"}]}
{"nct_id":"NCT02432521","start_date":"2015-03-31","enrollment":49,"brief_title":"Predictors of Treatment Response of Motor Sequels After a Stroke","official_title":"Predictors of Treatment Response of Motor Sequels After a Cerebrovascular Accident","primary_completion_date":"2017-06-30","study_type":"Observational","rec_status":"Unknown status","completion_date":"2017-07-31","last_update":"2017-07-05","description":"The cerebrovascular accident (CVA) is currently the leading cause of death in Brazil and it is estimated that there are about 62 million stroke survivors worldwide. Thus, the stroke sequels are a major public health problem not only in Brazil but in the world, with existing treatments often insufficient for complete recovery. Thus this study aims to identify predictors of different responses from rehabilitation therapy through the evaluation of clinical and neurophysiological data performed before and after treatment. For the neurophysiological study will be used the association of electroencephalogram (EEG) and transcranial magnetic stimulation (TMS). This last one will be performed in the baseline and after a single Transcranial direct current stimulation (tDCS) session, aiming to leverage the ability of those technics to analyze the cerebral plasticity. As a secondary objective: 1) Identify specific features of brain plasticity involved in recovery from stroke and discuss the possible implications of these findings in the therapeutic approach; 2) Search possible electrophysiological markers that can be used as surrogate outcome of stroke of motor sequel.","other_id":"35583814.1.0000.0068_CAAE","observational_model":"Ecologic or Community","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients of hemiplegia ambulatory from the Institute of Physical Medicine and\r\n        Rehabilitation (IMREA) from the Clinics Hospital (HC) of the Medical School of the\r\n        University of Sao Paulo (USP)","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Clinical and radiological diagnosis (Functional magnetic Resonance (FMR) and/or\r\n             Computerized tomography (TC) ) of the stroke;\r\n\r\n          -  More than one month from the date of the stroke;\r\n\r\n          -  Clinical stability;\r\n\r\n          -  Signed and dated informed consent form.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Disturbs that forbid the adherence in treatment;\r\n\r\n          -  Subjects already undergoing in other researches;\r\n\r\n          -  Pregnant women;\r\n\r\n          -  Lesions that could affect the proposed therapy;\r\n\r\n          -  The occurence of lesion or muscle,joint pain that could forbid the therapy;\r\n\r\n          -  Destabilization of the clinical comorbidities.\r\n      ","sponsor":"University of Sao Paulo General Hospital","sponsor_type":"Other","conditions":"Cerebrovascular Accident","interventions":[{"intervention_type":"Other","name":"Other: Conventional rehabilitation program from IMREA","description":"The IMREA rehabilitation program lasts about 18 weeks and consists of two weekly sessions of 60 minutes of physical therapy, occupational therapy, as well as weekly sessions of speech therapy, nursing, nutrition, psychology and social work. Conventional therapies are typically composed of stretching and strengthening exercises both upper and lower limbs, mobilizations, functional training. The only fact that differ the subjects from the protocol from the patients from the IMREA Institute are the clinical and neurophysiological evaluations that will be performed before and after the end of the conventional rehabilitation program previously described."}],"outcomes":[{"outcome_type":"secondary","measure":"Purdue Pegboard test","time_frame":"At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline"},{"outcome_type":"primary","measure":"Change in motor cortex excitability as measured by Transcranial magnetic stimulation (TMS)","time_frame":"At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline","description":"A noninvasive brain stimulation techniques suitable for measuring the motor cortex excitability"},{"outcome_type":"primary","measure":"Change in spontaneous electrical brain activity as assessed by Electroencephalogram (EEG)","time_frame":"At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline","description":"The record of the brain's spontaneous electrical activity"},{"outcome_type":"secondary","measure":"cinematic variables analyzed with robotic","time_frame":"At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline","description":"speed, acceleration, articular angulation, time-to-point, task execution time, target displacement"},{"outcome_type":"secondary","measure":"Mini-mental State Examination","time_frame":"At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline"},{"outcome_type":"secondary","measure":"Visual Analog Scale of Pain","time_frame":"At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline"},{"outcome_type":"secondary","measure":"Verbal fluency test","time_frame":"At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline"},{"outcome_type":"secondary","measure":"Boston naming test","time_frame":"At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline"},{"outcome_type":"secondary","measure":"Hamilton Rating scale of depression","time_frame":"At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline"},{"outcome_type":"secondary","measure":"The Kinesthetic and visual imagery questionnaire (KVIQ)","time_frame":"At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline"},{"outcome_type":"secondary","measure":"National Institutes of Health Stroke Scale (NIHSS)","time_frame":"At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline"},{"outcome_type":"secondary","measure":"Stroke Impact Scale (SIS)","time_frame":"At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline"},{"outcome_type":"secondary","measure":"Von Frey test","time_frame":"At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline"},{"outcome_type":"secondary","measure":"Functional Independence Measure","time_frame":"At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline"},{"outcome_type":"secondary","measure":"Epworth Sleepiness Scale","time_frame":"At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline"},{"outcome_type":"secondary","measure":"Fugl-Meyer Assessment","time_frame":"At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline"},{"outcome_type":"secondary","measure":"Medical Research Council Scale","time_frame":"At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline"},{"outcome_type":"secondary","measure":"Modified Ashworth Scale","time_frame":"At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline"},{"outcome_type":"secondary","measure":"Finger Tapping","time_frame":"At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline"},{"outcome_type":"secondary","measure":"Jebsen-Taylor Hand Function Test","time_frame":"At baseline, 11th week, 22nd week, and after 3 and 6 months from baseline"}]}
{"nct_id":"NCT02772016","start_date":"2015-03-31","phase":"Early Phase 1","enrollment":90,"brief_title":"Therapeutic Effect of Colla Corii Asini on Improving Anemia and Hemoglobin Composition in Pregnant Women With Thalassemia","primary_completion_date":"2016-05-31","study_type":"Interventional","rec_status":"Unknown status","last_update":"2016-05-13","description":"Seventy-two pregnant patients diagnosed of minor or intermediate beta thalassemia with mild anemia were randomly assigned to treatment group and control group. Patients in the treatment group were given 15 g of Colla corii asini in powder form daily for 4 weeks while the control group were observed and followed up in the same period without any treatments. Levels of hemoglobin(Hb), serum iron (SI), serum ferritin (SF) and three types of hemoglobin components [adult hemoglobin (HbA), fetal hemoglobin (HbF), minor adult hemoglobin (HbA2)] were measured before and after treatments.","other_id":"TH-1","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":20,"maximum_age":35,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  pregnant women diagnosed as thalassemia carriers by genetic test with clinical\r\n             presentation of minor or intermediate - thalassemia;\r\n\r\n          -  patients with mild anemia (80 g/L Hb<110 g/L) prior to study enrollment;\r\n\r\n          -  singleton pregnancy;\r\n\r\n          -  patients having not received blood transfusion or any forms of anti-anemia treatment\r\n             in Western Medicine or Traditional Chinese Medicine in the last 12 weeks;\r\n\r\n          -  informed consent obtained.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  patients with severe thalassemia;\r\n\r\n          -  patients with severe anemia (Hb<80 g/L) prior to study enrollment;\r\n\r\n          -  twin or multiple pregnancies;\r\n\r\n          -  patients with any of the following abnormalities: immunodeficiency, primary diseases\r\n             involving cardiovascular system, liver, kidney, gastrointestinal tract, endocrine\r\n             system and hematological system;\r\n\r\n          -  allergic to two or more drugs;\r\n\r\n          -  patients with mental illness or poor compliance to medical treatment;\r\n\r\n          -  patients having received blood transfusion or any forms of anti-anemia treatment in\r\n             Western medicine or Traditional Chinese Medicine in the last 12 weeks;\r\n\r\n          -  no informed consent obtained.\r\n      ","sponsor":"Yanfang Li","sponsor_type":"Other","conditions":"Thalassemia","interventions":[{"intervention_type":"Drug","name":"Drug: Colla corii asini","description":"15 g of Colla corii asini in powder form daily for 4 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Hemoglobin(Hb)","time_frame":"Four weeks","description":"the change of hemoglobin(g/L)"},{"outcome_type":"primary","measure":"Adult hemoglobin(HbA)","time_frame":"Four weeks","description":"the change of adult hemoglobin(%)"},{"outcome_type":"primary","measure":"Fetal hemoglobin(HbF)","time_frame":"Four weeks","description":"the change of fetal hemoglobin(%)"},{"outcome_type":"primary","measure":"Minor adult hemoglobin(HbA2)","time_frame":"Four weeks","description":"the change of minor adult hemoglobin(%)"},{"outcome_type":"secondary","measure":"Serum iron(SI)","time_frame":"Four weeks","description":"the change of serum iron (umol/L)"},{"outcome_type":"secondary","measure":"Serum ferritin(SF)","time_frame":"Four weeks","description":"the change of serum ferritin (ng/mL)"},{"outcome_type":"secondary","measure":"Adverse effect","time_frame":"Four weeks","description":"total white blood count(×109/L)"},{"outcome_type":"secondary","measure":"Adverse effect","time_frame":"Four weeks","description":"platelet count(×109/L)"},{"outcome_type":"secondary","measure":"Adverse effect","time_frame":"Four weeks","description":"percentage of neutrophil(%)"},{"outcome_type":"secondary","measure":"Adverse effect","time_frame":"Four weeks","description":"serum alanine aminotransferase(U/L)"},{"outcome_type":"secondary","measure":"Adverse effect","time_frame":"Four weeks","description":"serum aspartate aminotransferase(U/L)"},{"outcome_type":"secondary","measure":"Adverse effect","time_frame":"Four weeks","description":"urea nitrogen (mmol/L)"},{"outcome_type":"secondary","measure":"Adverse effect","time_frame":"Four weeks","description":"serum creatinine(umol/L)"}]}
{"nct_id":"NCT02312050","start_date":"2015-03-31","phase":"Phase 2","enrollment":375,"brief_title":"A Phase 2b Study of GCS-100 in Patients With Chronic Kidney Disease Caused by Diabetes","official_title":"A Phase 2b, Placebo-Controlled, Randomized, Double-Blind, Multi-Center Study of GCS-100 in Patients With Chronic Kidney Disease Caused by Diabetes","primary_completion_date":"2016-09-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2016-12-31","last_update":"2015-05-19","description":"A phase 2b, placebo-controlled, randomized, double-blind, multi-center study of GCS-100 in patients with chronic kidney disease caused by diabetes. The study will enroll approximately 375 patients at multiple centers located in the United States. Study duration is 6 months. Patients will be randomly assigned 1:1:1:1 to treatment with placebo (0.9% Sodium Chloride Injection, USP), 1 mg, 3 mg, or 9 mg GCS-100. All doses of study drug will be administered via intravenous (IV) push injection once weekly for 2 months (8 weeks), then every other week for an additional 4 months (16 weeks).","other_id":"LJ100-CKD04","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":90,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patient is capable of understanding the purpose and risks of the study and is able to\r\n             provide written informed consent.\r\n\r\n          2. Patient is  18 and  90 years of age.\r\n\r\n          3. Patient has a baseline eGFR of 15 to < 45 mL/min/1.73m2, defined as the average of 2\r\n             measurements collected at Screening Visits 1 and 2, and determined using the\r\n             4-variable Modification of Diet in Renal Disease (MDRD) equation.\r\n\r\n          4. Patients with diabetic CKD diagnosis > 12 months, and if requiring\r\n             renin-angiotensin-aldosterone system (RAAS) blockade medications, must be receiving\r\n             stable doses (i.e., not requiring modification) for the 3 months prior to first study\r\n             drug dose.\r\n\r\n          5. Stable eGFR as measured by a less than 25% variability of each Screening value from\r\n             the average of the 2 Screening values taken no less than 5 days and no more than 10\r\n             days apart.\r\n\r\n          6. Patient is willing and able to comply with all protocol requirements.\r\n\r\n          7. Female patients of childbearing potential (i.e., women who have not been surgically\r\n             sterilized or who have not been post-menopausal for at least 1 year) and male patients\r\n             with partners of childbearing potential must agree to use medically acceptable methods\r\n             of contraception throughout the study period.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Treatment with an experimental (unlicensed) drug within 4 weeks prior to Screening\r\n             visit 1.\r\n\r\n          2. Patients who are known to be allergic to citrus or have a history of any allergies\r\n             associated with hypersensitivity to citrus.\r\n\r\n          3. Patients who have begun new treatment with angiotensin converting enzyme inhibitors\r\n             (ACEIs), angiotensin receptor blockers (ARBs), mineralocorticoid receptor blockers\r\n             (MRBs), or direct renin inhibitors (DRIs) within the 3 months prior to first dose.\r\n\r\n          4. Kidney disease known to be due to causes other than diabetes.\r\n\r\n          5. Patients diagnosed with acute kidney injury (AKI) within the 3 months prior to first\r\n             dose.\r\n\r\n          6. Planned renal replacement therapy of any kind within 6 months of first study drug\r\n             dose.\r\n\r\n          7. Previous solid organ transplant.\r\n\r\n          8. Evidence of persistent, uncontrolled hypertension, i.e., systolic blood pressure  160\r\n             mmHg and diastolic blood pressure  100 mmHg; or evidence of persistent, uncontrolled\r\n             hypotension, i.e., systolic blood pressure  90 mmHg and diastolic blood pressure  40\r\n             mmHg at repeated measures during Screening.\r\n\r\n          9. Patients who have Screening clinical laboratory values of:\r\n\r\n               1. Hemoglobin:  9 g/dL\r\n\r\n               2. Total bilirubin: > 1.5X the upper limit of normal (ULN)\r\n\r\n               3. ALT and/or AST: > 2.5X ULN\r\n\r\n               4. HbA1c > 10.5%\r\n\r\n         10. Concomitant treatment with immunosuppressive agents, except for stable use of topical\r\n             agents or inhaled steroids.\r\n\r\n         11. Patients who have previously received GCS-100 as part of another clinical trial.\r\n\r\n         12. Known history of cancer (excluding non-melanoma skin cancer that is not being actively\r\n             treated) within 5 years of Screening.\r\n\r\n         13. Known history of human immunodeficiency virus, active hepatitis C virus (HCV), active\r\n             hepatitis B virus (HBV), or prior history of infection with HBV (HBcAb positive); if\r\n             adequate hepatic function has been documented for patients with HCV or prior history\r\n             of hepatitis B without evidence of cirrhosis, the Medical Monitor may approve their\r\n             enrollment.\r\n\r\n         14. Clinically relevant active infection and/or a serious co-morbid medical condition,\r\n             such as recent myocardial infarction (within the last 6 months), unstable angina,\r\n             difficult-to-control congestive heart failure, uncontrolled hypertension,\r\n             difficult-to-control cardiac arrhythmias, severe or uncontrolled chronic obstructive\r\n             or chronic restrictive pulmonary disease, and/or cirrhosis.\r\n\r\n         15. Patient had major surgery within 12 weeks of first study drug dose.\r\n\r\n         16. If female, patient is pregnant or breastfeeding.\r\n\r\n         17. Patient has a concomitant disease or condition, including laboratory abnormalities,\r\n             which, in the opinion of the investigator, could interfere with the conduct of the\r\n             study or put the patient at unacceptable risk.\r\n      ","sponsor":"La Jolla Pharmaceutical Company","sponsor_type":"Industry","conditions":"Diabetic Chronic Kidney Disease","interventions":[{"intervention_type":"Drug","name":"Drug: GCS-100","description":"1 mg, 3 mg, or 9 mg IV push injections"},{"intervention_type":"Drug","name":"Drug: Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"The change in eGFR from Screening to measurements taken at Week 26","time_frame":"26 weeks"},{"outcome_type":"secondary","measure":"Change in eGFR (as a scored value using 20% cut point) from Screening to Week 26","time_frame":"26 weeks"},{"outcome_type":"secondary","measure":"Change in eGFR (as a scored value using 30% cut point) from Screening to Week 26","time_frame":"26 weeks"},{"outcome_type":"secondary","measure":"Incidence of renal replacement therapy (RRT)","time_frame":"26 weeks"},{"outcome_type":"secondary","measure":"Incidence of major cardiac events","time_frame":"26 weeks"}]}
{"nct_id":"NCT02396719","start_date":"2015-03-31","enrollment":1541,"brief_title":"A Real-World Registry to Investigate the Performance of LenSx Laser in Chinese Patients","official_title":"A Prospective, Single-Arm, Multicenter, Registry Study to Investigate the Performance of Femtosecond Laser-Assisted Cataract Surgery in Chinese Cataract Patients","primary_completion_date":"2016-05-31","study_type":"Observational","rec_status":"Completed","completion_date":"2016-05-31","last_update":"2016-06-06","description":"The purpose of this study is to investigate the performance of LenSx Laser in femtosecond laser-assisted cataract surgery (FLACS) in real-world medical practice in Chinese patients.","other_id":"CTO130-P001","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"Chinese patients who undergo cataract surgery using LenSx Laser and phacoemulsification in\r\n        at least one eye will be eligible to participate.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Chinese;\r\n\r\n          -  Will undergo LenSx Laser-assisted cataract surgery and phacoemulsification in at\r\n             least one eye;\r\n\r\n          -  Must sign written informed consent;\r\n\r\n          -  Other protocol-specified inclusion criteria may apply.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Contraindications listed in LenSx Laser System Operator's Manual;\r\n\r\n          -  Pregnant, nursing, or planning a pregnancy;\r\n\r\n          -  Concurrent enrollment in another investigational drug and/or device study or\r\n             participation in such a study within 30 days prior to surgery day;\r\n\r\n          -  Other protocol-specified exclusion criteria may apply.\r\n      ","sponsor":"Alcon Research","sponsor_type":"Industry","conditions":"Cataracts","interventions":[{"intervention_type":"Device","name":"Device: LenSx Laser","description":"Used for cornea incision, capsulotomy and lens fragmentation during cataract surgery"}],"outcomes":[{"outcome_type":"primary","measure":"Completion rate of a round anterior capsulotomy","time_frame":"Surgery (Day 0)"},{"outcome_type":"secondary","measure":"Completion rate of lens fragmentation without additional segmentation after LenSx Laser procedure","time_frame":"Surgery (Day 0)"},{"outcome_type":"secondary","measure":"Completion rate of intraocular lens (IOL) implantation","time_frame":"Surgery (Day 0)"},{"outcome_type":"secondary","measure":"Completion rate of corneal incisions","time_frame":"Surgery (Day 0)"},{"outcome_type":"secondary","measure":"Best-corrected distance visual acuity (BCDVA)","time_frame":"Up to Day 30"},{"outcome_type":"secondary","measure":"Percentage of patients with BCDVA of 20/20, 20/25, 20/40 or better at each visit","time_frame":"Up to Day 30"}]}
{"nct_id":"NCT02343471","start_date":"2015-03-31","phase":"N/A","enrollment":26,"brief_title":"The Effect of Whey Protein Consumed as a Pre-meal on Postprandial Lipemia in Healthy and Subjects With Type 2 Diabetes","official_title":"Whey Protein, Postprandial Lipemia and Cardiovascular Disease: Evaluation of the Effect of a Pre-meal of Whey Protein on Postprandial Lipiemia in Subjects With the Metabolic Syndrome and Type 2 Diabetes","primary_completion_date":"2015-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-04-30","last_update":"2015-05-05","description":"Cardiovascular disease (CVD) is one of the most important and frequent causes of death. Postprandial lipidemia (PPL) is an independent risk factor for CVD, besides the traditional risk factors e.g. hypertension, high LDL-cholesterol, family disposition of CVD and type 2 diabetes (T2D). A high PPL is associated with an increased risk of myocardial infarction and stroke. Reduction of increased PPL, as a part of CVD prevention, is therefore pivotal. Especially in groups with increased risk of CVD, like the metabolic syndrome (MeS) and T2D. Identification of a simple diet-related method will possibly result in reduction of CVD in healthy as well as high-risk subjects. The aim of this project is to investigate the effect whey protein consumed as pre-meal prior to a fat-rich meal on responses of triglycerides and apolipoprotein B48 (ApoB48) in subjects with type 2 diabetes compared to healthy subjects. Secondarily the aim is to study the responses of glucose, insulin, glucagon, amino acids, inflammatory markers, incretins, rate of gastric emptying and metabolomics. Also satiety feeling will be measured. Investigators hypothesize that whey protein consumed 15 minutes prior to a fat-rich isocaloric meal reduces triglyceride- and ApoB48 responses more in type 2 diabetic subjects compared to healthy subjects. The investigators research will hopefully contribute to a better understanding of how PPL can be modified in a simple manner. It will promote innovation to the food industry for development and production of healthy food products, which can be applied in the fight against CVD in the background population in general and high-risk people in particular. Thus, the results of this project can impart knowledge of great importance both to the national and international food industry as well as the healthcare systems.","other_id":"CERN-Premeal3","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria - general:\r\n\r\n          -  Weight stable for the last three month.\r\n\r\n          -  BMI<40\r\n\r\n        Inclusion Criteria for subjects with type 2 diabetes:\r\n\r\n          -  Diagnosed type 2 diabetes (HbA1c > 48 mmol/l)\r\n\r\n          -  Stable dose of Metformin, Sulfonylurea (SU), insulin and SGLT inhibitors are accepted.\r\n\r\n        Exclusion Criteria - general:\r\n\r\n          -  Type 1 diabetes\r\n\r\n          -  Type 2 diabetes (HbA1c  48 mmol/L)\r\n\r\n          -  Fasting plasma triglycerides > 5.0 mmol/L\r\n\r\n          -  Blood pressure > 160/100 mmHg\r\n\r\n          -  Cardiovascular, liver, kidney or metabolic disease\r\n\r\n          -  Corticosteroid treatment\r\n\r\n          -  Pregnancy or lactation\r\n\r\n          -  Alcohol or drug abuse\r\n\r\n          -  Legal incapacity\r\n\r\n        Exclusion Criteria for subjects with type 2 diabetes:\r\n\r\n          -  Treatment with DPP-4 inhibitors, GLP-1 agonists and basal bolus insulin.\r\n\r\n          -  Fasting blood glucose  14 mmol/l.\r\n\r\n        Exclusion Criteria for healthy subjects:\r\n\r\n          -  Prediabetes, defined from the WHO criteria (IGF  6.1 mmol/l).\r\n      ","sponsor":"Aarhus University Hospital","sponsor_type":"Other","conditions":"Healthy|Type 2 Diabetes","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: 20 g whey protein"}],"outcomes":[{"outcome_type":"other","measure":"Responses of metabolomics measured as incremental Area Under the Curve (AUC -15 - 360 min) in plasma.","time_frame":"Prior to the pre meal (-15 min), prior to the main meal (0 min) and 120, 240 and 360 min post main meal"},{"outcome_type":"primary","measure":"Effect on triglyceride response of whey protein as pre-meal after a high-fat meal in healthy subjects and subjects with type 2 diabetes measured as incremental Area Under the Curve (iAUC -15 - 360 min).","time_frame":"Prior to the pre meal (-15 min), prior to the main meal (0 min) and 60, 90, 120, 180, 240 and 360 min post main meal"},{"outcome_type":"primary","measure":"Effect on apolipoprotein B48 of whey protein as pre-meal after a high-fat meal in healthy subjects and subjects with type 2 diabetes measured as incremental Area Under the Curve (iAUC -15 - 360 min).","time_frame":"Prior to the pre meal (-15 min), prior to the main meal (0 min) and 120, 240 and 360 min post main meal"},{"outcome_type":"secondary","measure":"Glucose responses measured as incremental Area Under the Curve (AUC -15 - 360 min)","time_frame":"Prior to the pre meal -15 min, -10 min, prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal"},{"outcome_type":"secondary","measure":"Insulin responses measured as incremental Area Under the Curve (AUC -15 - 360 min)","time_frame":"Prior to the pre meal -15 min, -10 min, prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal"},{"outcome_type":"secondary","measure":"Glucagon responses measured as incremental Area Under the Curve (AUC -15 - 360 min)","time_frame":"Prior to the pre meal -15 min, -10 min, prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal"},{"outcome_type":"secondary","measure":"Glucagon-like peptide 1 (GLP-1) responses measured as incremental Area Under the Curve (AUC -15 - 360 min)","time_frame":"Prior to the pre meal -15 min, -10 min, prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal"},{"outcome_type":"secondary","measure":"Gastric inhibitory peptide (GIP) responses measured as incremental Area Under the Curve (AUC -15 - 360 min).","time_frame":"Prior to the pre meal -15 min, -10 min, prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal"},{"outcome_type":"other","measure":"Responses of the inflammatory marker monocyte chemotactic protein-1 (MCP-1) measured as incremental Area Under the Curve (AUC -15 - 360 min)","time_frame":"Responses of the inflammatory marker monocyte chemotactic protein-1 (MCP-1) measured as incremental Area Under the Curve (AUC -30/-15 - 360 min)"},{"outcome_type":"other","measure":"Change in amino acids concentration from baseline to 360 min","time_frame":"Baseline (-15 min), 30, 180 and 360 min"},{"outcome_type":"other","measure":"Responses of free fatty acids measured as incremental Area Under the Curve (iAUC -15 - 360 min).","time_frame":"Prior to the pre meal -15 min, -10 min, prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal"},{"outcome_type":"other","measure":"Satiety measured as incremental Area Under the Curve (AUC -15 - 360 min)","time_frame":"Prior to the pre meal -15 min, -10 min, prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal"},{"outcome_type":"other","measure":"Responses of the inflammatory marker Rantes measured as incremental Area Under the Curve (AUC -15 - 360 min)","time_frame":"Prior to the pre meal -15 min, -10 min, prior to the main meal (0 min) and 15, 30, 60, 90, 120, 240 and 360 min post main meal"},{"outcome_type":"other","measure":"Responses of metabolomics measured as incremental Area Under the Curve (AUC -15 - 360 min) in urine","time_frame":"Prior to the pre meal (-15 min), and 120 and 360 min post main meal"},{"outcome_type":"other","measure":"Responses of satiety visual analog scale (VAS) measured as incremental Area Under the Curve (AUC -15 - 360 min)","time_frame":"Prior to the pre meal (-15 min), prior to the main meal (0 min) and 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 and 360 min post main meal"}]}
{"nct_id":"NCT02411123","start_date":"2015-03-31","phase":"N/A","enrollment":220,"brief_title":"Clinical Study to Evaluate Patient Outcomes Following Pharmacogenetic Testing of Subjects Exhibiting Neuropsychiatric Disorders","official_title":"Prospective Randomized Clinical Study to Evaluate Patient Outcomes Following Pharmacogenetic Testing of Subjects Exhibiting Neuropsychiatric Disorders","primary_completion_date":"2015-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-12-31","last_update":"2015-12-29","description":"The purpose of this study is to evaluate the effect of pharmacogenetic (PGx) testing on clinical outcomes in a group of subjects exhibiting neuropsychiatric disorders, such as depression and anxiety, as compared to a group of subjects with the same attributes without the guidance of PGx testing for their treatment. This study will also evaluate whether pharmacogenetic (PGx) testing can reduce adverse drug events, hospitalization rates, hospital length of stay, emergency room visits, disability, death or other serious drug side effects.","other_id":"CLP0002","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Diagnostic","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female subjects between the ages of 18 and 80\r\n\r\n          -  Experiencing or showing evidence of a neuropsychiatric disorder (depression, anxiety,\r\n             attention deficit hyperactivity disorder and psychosis) as determined by a qualified\r\n             clinician\r\n\r\n          -  Subjects new to the medical provider\r\n\r\n          -  Willing and able to comply with study procedures\r\n\r\n          -  Able to provide written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Unwilling or unable to provide written informed consent and to comply with study\r\n             procedures\r\n\r\n          -  Any subject for whom providing a buccal swab sample would be contraindicated or not\r\n             possible\r\n\r\n          -  Subject with a history of chronic renal dysfunction, Chronic Kidney Disease (Stage 4\r\n             or 5)\r\n\r\n          -  Abnormal hepatic function within the last 2 years (INR >1.2 not attributable to\r\n             anticoagulant medications, aspartate aminotransferase (AST) or alanine\r\n             aminotransferase (ALT) >1.5x normal, or suspected cirrhosis\r\n\r\n          -  History of malabsorption (short gut syndrome)\r\n\r\n          -  Any gastric or small bowel surgery less than 3 months prior to study enrollment\r\n\r\n          -  Subject is being treated with intravenous medication\r\n      ","sponsor":"AltheaDx","sponsor_type":"Industry","conditions":"Depression|Anxiety","interventions":[{"intervention_type":"Genetic","name":"Genetic: IDgenetix Neuropsychiatric Test Panel","description":"The IDgenetix Neuropsychiatric Test Panel is used to make recommendations on the medication therapy that might be impacted by the genetic background of the patient."}],"outcomes":[{"outcome_type":"primary","measure":"Comparison of change in neuropsychiatric state between the two treatment arms measured by Neuropsychiatric Questionnaire (NPQ)","time_frame":"4 months","description":"Neuropsychiatric Questionnaire (NPQ) score change comparison between the two treatment arms over a 4-month period."},{"outcome_type":"primary","measure":"Comparison of change in responsiveness between the two treatment arms measured by Symbol Digit Coding (SDC) test","time_frame":"4 months","description":"Symbol Digit Coding (SDC) test score change comparison between the two treatment arms over a 4-month period."},{"outcome_type":"secondary","measure":"Comparison of hospital utilization between the two treatment arms as measured by hospital admission and re-admission rates","time_frame":"4 months","description":"Comparison of hospital utilization, as measured by hospital admission and re-admission rates, between the two treatment arms over a 4-month period."},{"outcome_type":"secondary","measure":"Comparison of adverse drug events between the two treatment arms over a 4-month period","time_frame":"4 months","description":"Comparison of adverse drug events between the two treatment arms over a 4-month period"}]}
{"nct_id":"NCT02386384","start_date":"2015-03-31","enrollment":15,"brief_title":"TNF and MFG-E8: Novel Biomarkers to Predict Implantation Failure","official_title":"TNF (Tumor Necrosis Factor Alpha) and MFG-E8 (Milk Fat Globule-Epidermal Growth Factor 8): Novel Biomarkers to Predict Implantation Failure","primary_completion_date":"2017-07-31","study_type":"Observational","rec_status":"Completed","completion_date":"2017-07-31","last_update":"2017-07-27","description":"Question: Can implantation failure (IF) be predicted prior to in vitro fertilization (IVF)? A pilot, non-interventional, clinical study Prospective, controlled, cohort study","other_id":"15-01-FB-0004","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"Female","minimum_age":21,"maximum_age":35,"population":"women 21-35 years old attending an infertility clinic in an academic center","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  women 21-35y\r\n\r\n          -  with no contraindication to pregnancy\r\n\r\n          -  on no hormonal contraception\r\n\r\n          -  normal uterine cavity\r\n\r\n          -  absence of hydrosalpinges\r\n\r\n          -  normal ovarian reserve (FSH<13 mIU/.ml or AMH>1 ng/ml or normal antral follicular\r\n             count>10 total follicles <10 mm in diameter, American Society for Reproductive\r\n             Medicine-ASRM 2012).\r\n\r\n          -  Three groups of patients will be enrolled: 10 fertile controls (C1-10: women who are\r\n             participating in the donor egg program as egg donors), 10 with unexplained\r\n             implantation failure (IF1-10: patients who have failed IVF cycles -failure of\r\n             implantation following 2 or more cycles with transfer of embryos of good quality-at\r\n             least 2 cleaving embryos with 6-8 cells, grades 1- 3 (scale 1-highest and 5-poorest\r\n             morphology score), and normal uterus, and 10 with recurrent unexplained first\r\n             trimester miscarriages (RM1-10: 2 consecutive miscarriages under 10 weeks, after\r\n             spontaneous or IVF conceptions).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  contraindication to pregnancy\r\n\r\n          -  use of hormonal contraception\r\n\r\n          -  abnormal uterine cavity\r\n\r\n          -  hydrosalpinges\r\n\r\n          -  abnormal karyotype.\r\n\r\n          -  women who are pregnant or planning to get pregnant in the cycle in which they are\r\n             participating in this study\r\n\r\n          -  women who have had a hysterectomy (previous removal of your uterus)\r\n\r\n          -  have a current medical condition, which, in the opinion of the investigator, would\r\n             result in hazards to the subject, should she participate in the study or have a\r\n             current medical condition which would potentially confound the study results.\r\n      ","sponsor":"Eastern Virginia Medical School","sponsor_type":"Other","conditions":"Infertility|Recurrent Pregnancy Loss","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"concentration of MFG-E8 and TNFα in serum and in endometrial biopsies controls, IF and RM.","time_frame":"1 menstrual cycle"}]}
{"nct_id":"NCT02640703","start_date":"2015-03-31","phase":"Phase 3","enrollment":16,"brief_title":"Effect of Morning vs. Evening Vaccination on Hypoxia and Bradycardia of Preterm Infants: a Randomised Controled Trial","official_title":"Effect of Morning vs. Evening Vaccination on Hypoxia and Bradycardia of Preterm Infants: a Randomised Controled Trial","primary_completion_date":"2016-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-05-31","last_update":"2017-10-25","description":"Hypoxia/bradycardia are common symptoms after vaccination of preterm infants. Adults show diurnal variations in vaccination response, due to circadian regulation of the immune system. The investigators plan to investigate whether preterm infants also show differences in hypoxia/bradycardia rate upon morning vs. evening vaccination. Hypoxia/bradycardia is recorded by pulse oximetry starting 24 hours before until 48 hours after vaccination; parents also kept a sleep-diary. 24 hours after vaccination interleukin-6, interleukin-1 and C-reactive protein get determined. To control vaccination response, pertussis- and haemophilus-titers are determined before vaccination and at 4 months corrected age.","other_id":"Impfstudie","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","maximum_age":0.5,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  gestational Age: 26+0 to 30+6 Weeks of gestational age\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  bronchopulmonary dysplasia\r\n\r\n          -  periventricular leukomalacia\r\n\r\n          -  intraventricular hemorrhage >2\r\n\r\n          -  congenital malformations\r\n      ","sponsor":"University Hospital Tuebingen","sponsor_type":"Other","conditions":"Premature Birth|Intermittent Hypoxiema","interventions":[{"intervention_type":"Biological","name":"Biological: Infanrix + Prevenar 13","description":"Different time of application"}],"outcomes":[{"outcome_type":"primary","measure":"Number of hypoxia and bradycardia events","time_frame":"72 hours"},{"outcome_type":"secondary","measure":"Vaccination titer in blood sample after vaccination compared to vaccination titer in blood sample before vaccination","time_frame":"Before vaccination and at the age of 4 months (corrected age)"}]}
{"nct_id":"NCT03492372","start_date":"2015-03-31","enrollment":300,"brief_title":"Molecular Characterization of Spinal Tissue","official_title":"Molecular Characterization of Spinal Tissue","primary_completion_date":"2022-07-01","study_type":"Observational","rec_status":"Enrolling by invitation","completion_date":"2023-01-01","last_update":"2021-05-04","description":"The researchers are trying to identify molecular mechanisms that control spine deformity and degenerative changes that can be used for therapeutic strategies.","other_id":"14-008177","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":1,"maximum_age":80,"population":"Patients undergoing spinal surgery where spinal tissues (disc, cartilage, ligament, etc.)\r\n        is removed as discarded tissue, waste, or surgical debris.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Children and adults undergoing surgical procedures where spinal tissues are removed as\r\n             a normal part of their procedure. Material from adults may be collected as a control\r\n             group.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Surgeries where spinal tissues are not being removed.\r\n      ","sponsor":"Mayo Clinic","sponsor_type":"Other","conditions":"Spinal Diseases","interventions":[{"intervention_type":"Other","name":"Other: Waste tissues are collected at the time of spinal surgery.","description":"This is a single visit study. Waste tissues are collected at the time of spinal surgery."}],"outcomes":[{"outcome_type":"primary","measure":"RNA expression","time_frame":"Baseline","description":"Measure RNA levels in spinal tissues samples (ng/mL)"}]}
{"nct_id":"NCT02331238","start_date":"2015-03-31","phase":"N/A","enrollment":973,"brief_title":"Trial of a Middle School Coach Gender Violence Prevention Program","official_title":"Cluster-Randomized Trial of a Middle School Coach Gender Violence Prevention Program","primary_completion_date":"2017-11-10","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-12-31","last_update":"2019-01-15","description":"This cluster-randomized school-based study will examine the effectiveness of a program for the primary prevention of perpetration of teen dating violence and sexual violence among middle school male athletes. Engaging men and boys in preventing violence against women and girls is recognized by major global health organizations as a critical public health strategy. \"Coaching Boys into Men\" is a theory- and evidence based program intended to alter gender norms that foster teen dating violence/sexual violence perpetration, promote bystander intervention, and reduce teen dating violence/sexual violence perpetration. Coaches receive a 60-minute training and biweekly check-in from a violence prevention advocate to administer the intervention to their athletes via 12 mini-lessons conducted weekly throughout a sport season. In a randomized trial of program effectiveness among high school athletes (Centers for Disease Control and Prevention CE001561-01, PI Miller), male athletes receiving the program demonstrated increased positive bystander intervention behaviors and less verbal abuse perpetration compared to controls. This project seeks to test the effectiveness of this program with younger male athletes in grades 6-8.The innovations are three-fold: (1) testing the efficacy of a novel teen dating violence/sexual violence prevention program for middle school male athletes; (2) training athletic coaches in Teen Dating Violence/Sexual Violence prevention thus implementing primary prevention that does not rely on teachers or classroom time; and (3) integrating the goal of changing gender norms with the technique of a bystander intervention approach to reduce teen dating violence/sexual violence prevention. The experimental design involves a 2-armed cluster randomized- controlled trial in 41 middle schools (38 clusters) in Pennsylvania. Schools will be randomly assigned to either intervention or control (standard coaching) condition. Coaches in intervention schools will receive Coaching Boys into Men training. Baseline surveys will be collected for all intervention and control site athletes entering grades 6-8 at the start of each sports seasons across Year 1 (Time 1; N= 973 athletes). Follow up surveys will be collected at the end of each sports season (Time 2). All participating athletes will be re-surveyed 12 months after baseline (Time 3).","other_id":"PRO14020618","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":11,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        School eligibility:\r\n\r\n        Urban and suburban middle schools in the Pittsburgh, PA region with athletics program\r\n\r\n        Athlete eligibility:\r\n\r\n        Ages 11-14 (grades 6-8), student at a participating middle school, participating in an\r\n        athletic program led by coach participating in the research study\r\n\r\n        Exclusion Criteria:\r\n\r\n        School Eligibility:\r\n\r\n        Middle schools not in the Pittsburgh area\r\n\r\n        Athlete eligibility:\r\n\r\n        Outside age range, not participating on a sports team at the middle school in which they\r\n        are enrolled\r\n      ","sponsor":"University of Pittsburgh","sponsor_type":"Other","conditions":"Violence|Abuse","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: \"Coaching Boys into Men\" program","description":"\"Coaching Boys into Men\" program consists of 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rational for Coaching Boys into Men and the Coaching Boys into Men Coaches Kit. The coaches use this Coaching Boys into Men toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."}],"outcomes":[{"outcome_type":"primary","measure":"Change in Positive Bystander Behavior from Baseline to Follow Up","time_frame":"3 months and 12 months","description":"Assessment of past 3 month positive bystander behavior in athletes when witnessing disrespectful and harmful behavior among peers comparing baseline and follow up summary scores. Athletes report if they have witnessed peers' abusive behaviors in the past 3 months and if witnessed, how they responded (whether they intervened to interrupt the behavior)"},{"outcome_type":"secondary","measure":"Change in Recognition of Abusive Behavior from Baseline to Follow Up","time_frame":"3 months and 12 months","description":"Recognition of disrespectful and harmful behaviors against girls as abusive comparing baseline and follow up mean scores on the recognition of abusive behavior scale."},{"outcome_type":"secondary","measure":"Change in Gender Equitable Attitudes Scale from Baseline to Follow Up","time_frame":"3 months and 12 months","description":"Assessment of gender-equitable attitudes comparing baseline and follow up mean scores on the gender attitudes scale"},{"outcome_type":"secondary","measure":"Change in Intentions to Intervene from Baseline to Follow Up","time_frame":"3 months and 12 months","description":"Proclivity to intervene when witnessing disrespectful and harmful behaviors among peers comparing baseline and follow up mean scores on a scale assessing likelihood of trying to stop disrespectful behaviors among peers."},{"outcome_type":"secondary","measure":"Change in self-reported recent (past 3 month) perpetration of Teen Dating Violence/Sexual Violence at 12 months","time_frame":"12 Months","description":"Assessment of Teen Dating Violence/Sexual Violence perpetration comparing baseline summary score with follow up 12 month summary score (whether participants have perpetrated acts of Teen Dating Violence or Sexual Violence towards anyone)"}]}
{"nct_id":"NCT02356198","start_date":"2015-03-31","phase":"N/A","enrollment":209,"brief_title":"Exparel Transversus Abdominis Plane Block vs Intrathecal Analgesia In Colorectal Surgery","official_title":"Exparel Transversus Abdominis Plane Block vs Intrathecal Analgesia In Colorectal Surgery: A Prospective Randomized Trial","primary_completion_date":"2017-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-10-31","last_update":"2019-03-07","description":"This study is prospective, randomized trial in which EXPAREL TAP block is compared to standard IT opioid administration, in relieving postoperative pain, decreasing length of stay, and use of narcotic medication.","other_id":"14-003143","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -   All patients undergoing elective laparoscopic or open colorectal resections who are\r\n             eligible for IT\r\n\r\n               -  Age >18 years\r\n\r\n               -  BMI <40\r\n\r\n               -  Ability to understand and read English\r\n\r\n        Exclusion Criteria:\r\n\r\n          -   Not able or unwilling to sign consent.\r\n\r\n               -  Currently pregnant or lactating.\r\n\r\n               -  Patients with chronic pain, requiring daily opiate use at time of surgery.\r\n\r\n               -  Patients intolerant of opiates, NSAIDS, acetaminophen or local anesthetics.\r\n\r\n               -  Patients requiring emergent surgery.\r\n\r\n               -  Abdominoperineal resections\r\n\r\n               -  Any contraindications to neuraxial analgesia (coagulopathy, localized infection\r\n                  at the potential site of injection, pre-existing spinal canal pathology)\r\n\r\n               -  Patients with a diagnosis of inflammatory bowel disease\r\n      ","sponsor":"Mayo Clinic","sponsor_type":"Other","conditions":"Conditions Requiring Colorectal Surgery","interventions":[{"intervention_type":"Drug","name":"Drug: EXPAREL","description":"transversus abdominis plane injection"},{"intervention_type":"Drug","name":"Drug: Intrathecal hydromorphone","description":"Intrathecal opioid administration"}],"outcomes":[{"outcome_type":"primary","measure":"Mean Pain Score","time_frame":"First 48 hours post operative","description":"Postoperative mean pain score for 48 hours after surgery. Pain was assessed on a 0 to 10 point visual analog scale (VAS), with 0 indicating no pain and 10 indicating severe pain. The mean pain score was summarized as the area under the curve (AUC) of the observed pain score, normalized for the total time of observation."},{"outcome_type":"primary","measure":"Total Morphine Milligram Equivalents Use (MME)","time_frame":"First 48 hours post operative","description":"The total cumulative use of opioids administered within 48 hours after surgery. MME is a standard value based on morphine and its potency assigned to all opioids to represent relative potencies."},{"outcome_type":"secondary","measure":"Total Length of Hospital Stay","time_frame":"post-operative to discharge","description":"Length of stay was defined as the total number of nights spent in the hospital after surgery."},{"outcome_type":"secondary","measure":"Number of Participants With Post-operative Ileus","time_frame":"24 hours post-operatively","description":"Post-operative ileus was defined as the inability to tolerate oral diet and/or the absence of flatus over 24 hours after surgery."},{"outcome_type":"secondary","measure":"Use of Intravenous Patient-controlled Analgesia","time_frame":"First 48 hours post-operative","description":"The total number of patients that used patient-controlled analgesia within 48 hours after surgery."}]}
{"nct_id":"NCT02436278","start_date":"2015-03-31","enrollment":132,"brief_title":"The Predictive Ability of 4MGS in IPF","official_title":"Does 4 Metre Gait Speed (4MGS) Predict Mortality and Non-elective Hospitalisation in Patients With Idiopathic Pulmonary Fibrosis (IPF)?","primary_completion_date":"2017-10-20","study_type":"Observational","rec_status":"Completed","completion_date":"2017-10-20","last_update":"2017-11-09","description":"This study investigates whether usual walking speed, measured by the 4 metre gait speed test (4MGS), and change in usual walking speed over 6 months predicts death and hospital admissions in patients with Idiopathic Pulmonary Fibrosis.","other_id":"15/LO/0015","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":99,"population":"Patients diagnosed with IPF according to NICE guidelines","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  IPF diagnosis according to NICE guidelines\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Significant co-morbidities that would limit walking ability, exercise capacity or make\r\n             exercise unsafe (e.g. unstable ischaemic heart disease, neuromuscular disease, severe\r\n             hip/lower limb joint pain, peripheral vascular disease, lower limb amputation)\r\n\r\n          -  Any patient whom the chief investigator feels it is unsafe to exercise (e.g. unstable\r\n             cardiovascular disease)\r\n\r\n          -  Any condition that precludes providing informed consent e.g. cognitive impairment or\r\n             poor English\r\n      ","sponsor":"Royal Brompton & Harefield NHS Foundation Trust","sponsor_type":"Other","conditions":"Idiopathic Pulmonary Fibrosis","interventions":[{"intervention_type":"Other","name":"Other: 4MGS","description":"Usual walking speed measured over 4 metres"}],"outcomes":[{"outcome_type":"primary","measure":"Mortality","time_frame":"12 months","description":"IPF-specific and all-cause mortality"},{"outcome_type":"secondary","measure":"Non-elective hospital admissions","time_frame":"12 months","description":"IPF-specific and all-cause hospital admissions"}]}
{"nct_id":"NCT02408913","start_date":"2015-03-26","phase":"Phase 1","enrollment":140,"brief_title":"VRC 208: Dose, Safety and Immunogenicity of a Recombinant Modified Vaccinia Virus Ankara Ebola Vaccine, VRC-EBOMVA079-00-VP (MVA-EbolaZ), Administered Alone or as a Boost to cAd3-Ebola Vaccines in Healthy Adults","official_title":"VRC 208: Phase 1/1b Open-Label Clinical Trial to Evaluate Dose, Safety and Immunogenicity of Recombinant Modified Vaccinia Virus Ankara Ebola Vaccine,VRC-EBOMVA079-00-VP, Administered Alone or as Boost to cAd3-Ebola Vaccines in Healthy Adults","primary_completion_date":"2017-04-06","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-04-06","last_update":"2019-04-11","description":"Background: - Ebola virus is a rare disease that starts with fever and muscle aches, but can lead to death. The 2014 Ebola outbreak in West Africa is the largest to date. There are no approved treatments for Ebola. Researchers want to see if two new vaccines VRC-EBOMVA079-00-VP (MVA-EbolaZ) and VRC-EBOADC069-00VP ( cAd3-EBO ) are safe and able to induce an immune response against Ebola. Objectives: - To see if the two new vaccines are safe and if they cause any side effects. Also, to study immune responses to the vaccines. Eligibility: - Healthy adults ages 18-66 Design: - Participants will get one or two study vaccine injections depending on the study group they are assigned to. Each injection will repeat the same schedule: - A needle and syringe will inject the vaccine into an upper arm muscle. - 1-2 days later, participants must call the clinic to report how they feel. - For 7 days they will check their temperature with a thermometer given to them. They will look at the injection site, and measure any redness or swelling with a ruler. They will write down any symptoms they have. - In the first 2 months, participants will have at least 6 clinic visits and 1 phone contact. At each visit, participants will be checked for health changes or problems. They will tell how they feel and if they have taken any medications. Blood and urine samples may be collected. - Participants might need to have extra clinic visits and laboratory tests if they have health changes that need to be checked.","other_id":"150107","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":66,"population":"","criteria":"\n        -  INCLUSION CRITERIA:\r\n\r\n        Inclusion Criteria for Groups 1, 2, and 3.\r\n\r\n        A volunteer must meet all of the following criteria to be eligible:\r\n\r\n          1. 18 to 50 years old.\r\n\r\n          2. Available for clinical follow-up through the last study visit.\r\n\r\n          3. Able to provide proof of identity to the satisfaction of the study clinician\r\n             completing the enrollment process.\r\n\r\n          4. Able and willing to complete the informed consent process.\r\n\r\n          5. Willing to donate blood for sample storage to be used for future research.\r\n\r\n          6. In good general health without clinically significant medical history.\r\n\r\n          7. Physical examination and laboratory results without clinically significant findings\r\n             and a body mass index (BMI) less than or equal to 40 within the 56 days prior to\r\n             enrollment.\r\n\r\n             Laboratory Criteria within 56 days prior to enrollment:\r\n\r\n          8. Hemoglobin within institutional normal range or accompanied by the Principal\r\n             Investigator (PI) or designee approval.\r\n\r\n          9. White blood cells (WBC) = 3,300-12,000 cells/mm(3).\r\n\r\n         10. WBC differential either within institutional normal range or accompanied by the PI or\r\n             designee approval.\r\n\r\n         11. Total lymphocyte count greater than or equal to 800 cells/mm(3).\r\n\r\n         12. Platelets = 125,000-400,000/mm(3).\r\n\r\n         13. Alanine aminotransferase (ALT) less than or equal to 1.25 times upper limit of normal.\r\n\r\n         14. Serum creatinine less than or equal to 1.1 times upper limit of normal.\r\n\r\n         15. Partial thromboplastin time (PTT) less than or equal to 1.1 times upper limit of\r\n             normal or accompanied by the Principal Investigator (PI) or designee approval.\r\n\r\n         16. Prothrombin time (PT) less than or equal to1.1 times upper limit of normal or\r\n             accompanied by the Principal Investigator (PI) or designee approval.\r\n\r\n         17. HIV-uninfected as evidenced by a negative FDA-approved HIV diagnostic blood test.\r\n\r\n             -Female-Specific Criteria:\r\n\r\n         18. Negative beta-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) on\r\n             day of enrollment if woman is presumed to be of reproductive potential.\r\n\r\n         19. Agrees to use an effective means of birth control from at least 21 days prior to\r\n             enrollment through 24 weeks after last study vaccination if presumed to be of\r\n             reproductive potential.\r\n\r\n        EXCLUSION CRITERIA:\r\n\r\n        Exclusion Criteria for Groups 1, 2, and 3\r\n\r\n        A volunteer will be excluded if one or more of the following conditions apply:\r\n\r\n        Volunteer has received any of the following substances:\r\n\r\n          1. Investigational Marburg vaccine in a prior clinical trial.\r\n\r\n          2. Investigational Ebola vaccine in a prior clinical trial.\r\n\r\n          3. Investigational cAd3 or MVA vaccines in a prior clinical trial.\r\n\r\n          4. Evidence of increased cardiovascular disease risk defined as >10% five year risk by\r\n             the non-laboratory method.\r\n\r\n          5. Electrocardiogram (ECG) with clinically significant abnormalities (examples may\r\n             include: pathologic Q waves, significant ST-T wave changes, left ventricular\r\n             hypertrophy, any non-sinus rhythm excluding isolated premature atrial contractions,\r\n             right or left bundle branch block, advanced A-V heart block). ECG abnormalities\r\n             determined by a cardiologist to be clinically insignificant as related to study\r\n             participation do not preclude study enrollment.\r\n\r\n          6. Type 1 hypersensitivity reaction to aminoglycoside antibiotics.\r\n\r\n          7. More than 10 days of systemic immunosuppressive medications except for short-term\r\n             treatments of minor ailments in otherwise healthy volunteers, or cytotoxic medications\r\n             within the 4 weeks prior to enrollment, or any within the 14 days prior to enrollment.\r\n\r\n          8. Blood products within 112 days (16 weeks) prior to enrollment.\r\n\r\n          9. Investigational research agents within 28 days (4 weeks) prior to enrollment.\r\n\r\n         10. Live attenuated vaccines within 28 days (4 weeks) prior to enrollment.\r\n\r\n         11. Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal within 2\r\n             weeks of initial study vaccine administration unless approved by the study Principal\r\n             Investigator (PI) or designee\r\n\r\n         12. Current anti-tuberculosis prophylaxis or therapy.\r\n\r\n             -Female-specific criteria:\r\n\r\n         13. Woman who is breast-feeding or planning to become pregnant during the 24 weeks of\r\n             study participation.\r\n\r\n             -Volunteer has a history of any of the following clinically significant conditions:\r\n\r\n         14. Serious adverse reactions to vaccines such as anaphylaxis, urticaria (hives),\r\n             respiratory difficulty, angioedema, or abdominal pain.\r\n\r\n         15. Clinically significant autoimmune disease or immunodeficiency.\r\n\r\n         16. Asthma that is not well controlled.\r\n\r\n         17. Diabetes mellitus (type I or II), with the exception of gestational diabetes.\r\n\r\n         18. Thyroid disease that is not well controlled.\r\n\r\n         19. A history of hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic\r\n             forms of angioedema.\r\n\r\n         20. Idiopathic urticaria within the last 1 year.\r\n\r\n         21. Hypertension that is not well controlled.\r\n\r\n         22. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or\r\n             platelet disorder requiring special precautions) or significant bruising or bleeding\r\n             difficulties with IM injections or blood draws.\r\n\r\n         23. Malignancy that is active or history of a malignancy that is likely to recur during\r\n             the period of the study.\r\n\r\n         24. Seizure in the past 3 years or treatment for seizure disorder in the past 3 years.\r\n\r\n         25. Asplenia or functional asplenia.\r\n\r\n         26. Psychiatric condition that precludes compliance with the protocol; past or present\r\n             psychoses; or within five years prior to enrollment, history of a suicide plan or\r\n             attempt.\r\n\r\n         27. Any medical, psychiatric, social condition, occupational reason or other\r\n             responsibility that, in the judgment of the investigator, is a contraindication to\r\n             protocol participation or impairs a volunteer s ability to give informed consent.\r\n      ","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","sponsor_type":"NIH","conditions":"Healthy Adult Immune Responses to Vaccine","interventions":[{"intervention_type":"Biological","name":"Biological: VRC-EBOMVA079-00-VP (MVA-EbolaZ)","description":"Ebola Modified Vaccinia Virus Ankara Vaccine"},{"intervention_type":"Biological","name":"Biological: VRC-EBOADC069-00-VP (cAd3-EBO)","description":"Ebola Chimpanzee Adenovirus Vector Vaccine"}],"outcomes":[{"outcome_type":"secondary","measure":"T cell responses as measured by intracellular cytokine staining (ICS)assay.","time_frame":"4 weeks after vaccination."},{"outcome_type":"primary","measure":"Local and systemic reactogenicity signs and symptoms.","time_frame":"Daily for 7 days following the vaccination"},{"outcome_type":"primary","measure":"Occurrence of adverse events of all severities.","time_frame":"Through 4 weeks after each injection"},{"outcome_type":"primary","measure":"Occurrence of serious adverse events and new chronic medical conditions.","time_frame":"Through 48 weeks after last injection"},{"outcome_type":"secondary","measure":"Antibody responses as measured by ELISA and neutralization assays.","time_frame":"4 weeks after vaccination."}]}
{"nct_id":"NCT03352544","start_date":"2015-03-16","phase":"N/A","enrollment":50,"brief_title":"Exercise in Severe Mental Illness. The PsychiActive Project","official_title":"Exercise Training in Patients With Severe Mental Illness. The PsychiActive Project","primary_completion_date":"2015-08-05","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-12-23","last_update":"2018-09-05","description":"The purpose of this randomized controlled trial is to study the effects of exercise on body weight, body composition, anthropometric and fasting blood measures, physical fitness, pulmonary function, quality of life, and lifestyle habits in patients with severe mental illness.","other_id":"CTS948AFS17","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Patients with severe mental illness established by experienced psychiatrists, aged 18 years\r\n        or older and stabilized on antipsychotic medication during the last month.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Patients with clinical instability, co-morbid substance abuse, or evidence of uncontrolled\r\n        cardiovascular, neuromuscular and endocrine disorders.\r\n      ","sponsor":"Universidad Pablo de Olavide","sponsor_type":"Other","conditions":"Exercise Therapy","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Exercise","description":"Exercise training for 12 weeks (aerobic and resistance training trice a week)"}],"outcomes":[{"outcome_type":"primary","measure":"Body weight","time_frame":"12 weeks","description":"In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)"},{"outcome_type":"primary","measure":"Fat mass","time_frame":"12 weeks","description":"In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)"},{"outcome_type":"primary","measure":"Lean mass","time_frame":"12 weeks","description":"In kilograms. Using the InBody 770 Body Composition Analyzer (Biospace Ltd, Seoul, Korea)"},{"outcome_type":"primary","measure":"Waist girth","time_frame":"12 weeks","description":"In millimeters. Using a measuring tape (Harpenden Anthropometric Tape; Holtain, Dyfed, UK) placed at the midpoint between the last rib and the iliac crest"},{"outcome_type":"primary","measure":"Hip girth","time_frame":"12 weeks","description":"In millimeters. Using a measuring tape (Harpenden Anthropometric Tape; Holtain, Dyfed, UK) placed atthe maximum width over the greater trochanters"},{"outcome_type":"primary","measure":"Blood glucose","time_frame":"12 weeks","description":"In milligram per deciliter. Collected in the morning after an overnight fast"},{"outcome_type":"primary","measure":"Blood cholesterol","time_frame":"12 weeks","description":"In milligram per deciliter. Collected in the morning after an overnight fast"},{"outcome_type":"primary","measure":"Blood triglyceride","time_frame":"12 weeks","description":"In milligram per deciliter. Collected in the morning after an overnight fast"},{"outcome_type":"secondary","measure":"Lower body strength","time_frame":"12 weeks","description":"In number of full stands. Using the 30-second chair stand test"},{"outcome_type":"secondary","measure":"Upper body strength","time_frame":"12 weeks","description":"In number of bicep curls. Using the 30-second arm curl test"},{"outcome_type":"secondary","measure":"Aerobic endurance","time_frame":"12 weeks","description":"In meters. Using the 6-min walk test"},{"outcome_type":"secondary","measure":"Lower body flexibility","time_frame":"12 weeks","description":"In centimeters. Using the chair sit-and-reach test"},{"outcome_type":"secondary","measure":"Upper body flexibility","time_frame":"12 weeks","description":"In centimeters. Using the back scratch test"},{"outcome_type":"secondary","measure":"Dynamic balance","time_frame":"12 weeks","description":"In seconds. Using the 8-foot up-and-go test"},{"outcome_type":"secondary","measure":"Static balance","time_frame":"12 weeks","description":"In seconds. Using the stork balance test"},{"outcome_type":"secondary","measure":"Forced vital capacity","time_frame":"12 weeks","description":"In liters. Using spirometry (Spirolab II. Medical International Research, Rome, Italy)"},{"outcome_type":"secondary","measure":"Health status","time_frame":"12 weeks","description":"Using the Short Form 36-Item Health Survey questionnaire version 2. Examines eight domains of physical (physical functioning, physical role, body pain, and general health) and mental health status (vitality, social functioning, emotional role, and mental health). The four physical-domains are summarized into a physical component score, and the four mental-domains constitute a mental component score. Scores range from 0 to 100 points, with higher scores indicating better health status."},{"outcome_type":"secondary","measure":"Quality of life","time_frame":"12 weeks","description":"Using the Tolerability and Quality of Life questionnaire. Score range from 8 to 32 points. Higher lower represent a better quality of life."},{"outcome_type":"secondary","measure":"Psychopathological symptoms","time_frame":"12 weeks","description":"Using the Brief Symptom Inventory-18 questionnaire. Score range from 0 to 72 points. Higher values represent a higher psychopathological severity."},{"outcome_type":"secondary","measure":"Anxiety symptoms","time_frame":"12 weeks","description":"Using the Beck Anxiety Inventory questionnaire. Score range from 0 to 63 points. Higher values represent a higher level of anxiety."},{"outcome_type":"secondary","measure":"Depression symptoms","time_frame":"12 weeks","description":"Using the Beck depression inventory-II questionnaire. Score range from 0 to 63 points. Higher values represent a higher level of depression."},{"outcome_type":"secondary","measure":"Self-Esteem","time_frame":"12 weeks","description":"Using the Rosenberg Self-Esteem Scale. Score range from 10 to 40 points. Higher values represent a higher self-esteem."},{"outcome_type":"secondary","measure":"Physical activity","time_frame":"12 weeks","description":"Using the Short form International Physical Activity Questionnaire. In metabolic equivalent minutes per week. Higher values represent a higher level of physical activity."},{"outcome_type":"secondary","measure":"Smoking","time_frame":"12 weeks","description":"Using the Fagerström nicotine dependence questionnaire. Score range from 0 to 10 points. Higher values represent a higher nicotine dependece."}]}
{"nct_id":"NCT02772536","start_date":"2015-03-10","phase":"N/A","enrollment":32,"brief_title":"A Clinical Trial Investigating Effect of Tinted Light on Perception of Tinnitus","official_title":"An Open Design Clinical Trial Investigating the Effect of Tinted Light on Perception of Tinnitus to Establish Its Efficacy","primary_completion_date":"2017-12-09","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-12-09","last_update":"2020-01-30","description":"Background An earlier pilot study provided evidence that about 40% of tinnitus sufferers reported that viewing particular tints of light appeared to result in some improvement of their tinnitus. This ameliorative effect appeared to be primarily acute and only reported to occur whilst viewing the tint. Individual patients would choose differing tints with some identifying more than one tint that affected their tinnitus. Aim of the Study In this current basic science study, the aim is to provide preliminary data to return estimates of the efficacy of using tinted light to ameliorate tinnitus. After identification of responders during screening, responders are invited to attend three further trial sessions, where their tinnitus is assessed in response to three luminance conditions: Low Ambient Light; Tint of Light affecting Tinnitus; White Light. The response to low ambient light serves as a control to compare the effect of tinted light against and the response to white light serves as an 'active' stimulus comparator. These results will then establish whether tinted light provides patients with a useful improvement in their tinnitus compared with measures of their baseline tinnitus obtained in the dark and against a standardised white light stimulus. They will also inform further development of the technique as a potential treatment for tinnitus in responsive patients. Over the three sessions, the averaged responses given by the patient under each stimulus condition will be analysed to provide a measure of efficacy.","other_id":"0473","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Aged 18 + years\r\n\r\n          -  Not receiving other tinnitus therapy or involved in any other tinnitus trial\r\n\r\n          -  To be in reasonable or good general health\r\n\r\n          -  Willing and able to give informed consent for participation in the study\r\n\r\n          -  Able to understand simple verbal explanation in English\r\n\r\n          -  Able to provide simple clear verbal feedback in English\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Aged under 18 yrs\r\n\r\n          -  Suffering only acute occasional tinnitus or non-intrusive tinnitus\r\n\r\n          -  Any serious illness that may adversely affect participation for example cancer,\r\n             dementia/neurodegenerative illness, psychoses, stroke\r\n\r\n          -  Receiving other treatments for tinnitus during the trial\r\n\r\n          -  Unable or unwilling to give consent\r\n\r\n          -  Unable to understand or speak English\r\n      ","sponsor":"University of Leicester","sponsor_type":"Other","conditions":"Tinnitus","interventions":[{"intervention_type":"Other","name":"Other: Visual Stimulus Condition Set","description":"In this single arm study, all participants are subject to a set of three visual stimulus conditions.\r\nLow ambient light for 10 mins: Self selected tinted light (20 Mins); White light (20 mins).\r\nVAS/CGI scores for each stimulus condition in the above set are reported at five minute intervals."}],"outcomes":[{"outcome_type":"primary","measure":"Averaged difference between dark and optimal tint tinnitus annoyance Visual Analogue Score (VAS)","time_frame":"At the end of the participation period in the efficacy phase of trial, typically 4-6 weeks.","description":"As described in the protocol, during the efficacy phase of the trial, the participant attends clinic on three occasions. At each visit, the participant provides tinnitus annoyance VAS values at set time points during the presentation of the three visual stimulus conditions (dark, optimal light tint, white light). At the end of each visit, the tinnitus annoyance VAS for the different visual stimulus conditions is then averaged. The difference between the averaged annoyance VAS for dark and the optimal light tint is calculated for each visit.\r\nAfter the final visit, the difference between the dark and optimal light tint conditions over all three visits is then averaged. This averaged difference in tinnitus annoyance over all three visits is then used as the primary outcome measure for the study."},{"outcome_type":"secondary","measure":"Averaged difference between dark and optimal tint tinnitus loudness Visual Analogue Score (VAS)","time_frame":"At the end of the participation period in the efficacy phase of trial, typically 4-6 weeks.","description":"As described in the protocol, during the efficacy phase of the trial, the participant attends clinic on three occasions. At each visit, the participant provides tinnitus loudness VAS values at set time points during the presentation of the three visual stimulus conditions (dark, optimal light tint, white light).\r\nAt the end of each visit, the tinnitus loudness VAS for the different visual stimulus conditions is then averaged. The difference between the averaged loudness VAS for dark and the optimal light tint is calculated for each visit.\r\nAfter the final visit, the difference between the dark and optimal light tint conditions over all three visits is then averaged. This averaged difference in tinnitus loudness over all three visits is then used as a secondary outcome measure for the study."},{"outcome_type":"other","measure":"Averaged difference between dark and optimal tint Clinical Global Index Values","time_frame":"At the end of the participation period in efficacy phase of trial, typically 4-6 weeks.","description":"As described in the protocol, during the efficacy phase of the trial, the participant attends clinic on three occasions. At each visit, the participant provides CGI values at set time points during the presentation of the three visual stimulus conditions (dark, optimal light tint, white light).\r\nAt the end of each visit, the CGI values for the different visual stimulus conditions are then averaged. The difference between the averaged CGI value dark and the optimal light tint is calculated for each visit.\r\nAfter the final visit, the difference in CGI values over the dark and optimal light tint conditions over all three visits is then averaged. This averaged CGI value difference over all three visits is then used as a further secondary outcome measure for the study."}]}
{"nct_id":"NCT02593383","start_date":"2015-03-01","phase":"Phase 1/Phase 2","enrollment":245,"brief_title":"Compound Adapalene and Clindamycin Hydrochloride Gel in Treatment of Patients With Acne","official_title":"A Placebo Control, Multicenter, Randomized, Double Blind, Multi-formula Groups, and Parallel Phase b+a Study Evaluating the Safety and Efficacy of Compound Adapalene and Clindamycin Hydrochloride Gel in Treatment of Patients With Acne","primary_completion_date":"2017-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-07-31","last_update":"2019-09-24","description":"evaluate the safety and efficacy of Compound Adapalene and Clindamycin Hydrochloride Gel in treatment of chinese patients with acne.","other_id":"zhaoke-2015-02","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age from 18 to 40 years old, female or male;\r\n\r\n          2. Class I-III of Acne vulgaris according to the International Modified PILLSBURY\r\n             Classification;\r\n\r\n          3. Patients voluntarily take part in the study and sign the ICF.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. The subject is known to be allergic to adapalene, clindamycin hydrochloride,\r\n             clindamycin, and / or any components of gel excipient;\r\n\r\n          2. Patients with secondary acne including occupational acne and corticosteroid-induced\r\n             acne;\r\n\r\n          3. The affected skin has other concomitant lesion (such as solar dermatitis, psoriasis,\r\n             seborrheic dermatitis, eczema and extremely severe acne) which may impact the efficacy\r\n             evaluation;\r\n\r\n          4. Subject has the history of regional enteritis, ulcerative colitis or\r\n             antibiotic-associated colitis;\r\n\r\n          5. Patient has history of severe cardiac disease and hypertension;\r\n\r\n          6. Patient has severe liver and kidney diseases with AST/ALT more than twice upper\r\n             limitation, or Cr, total cholesterol and triglycerides above normal range;\r\n\r\n          7. Patients with severe endocrine diseases, blood diseases, and neuropsychiatric\r\n             disorders;\r\n\r\n          8. Patients are known to have severe immune dysfunction, or need long-term use of\r\n             corticosteroids or immunosuppressive agents;\r\n\r\n          9. Pregnant or breastfeeding women, or unwilling to take effective contraceptive measures\r\n             during the study;\r\n\r\n         10. Alcoholic patients or drug abusers;\r\n\r\n         11. Patient has used other acne drugs topically within 2 weeks before the study start;\r\n\r\n         12. Patient has been administered with victoria A acid, vitamins, and antibiotics within 4\r\n             weeks before the study start;\r\n\r\n         13. Patient has participated in other study within 3 months before the study start;\r\n\r\n         14. The subject is not fit to take part in this study in the judgment of the investigator.\r\n      ","sponsor":"Lee's Pharmaceutical Limited","sponsor_type":"Industry","conditions":"Acne","interventions":[{"intervention_type":"Drug","name":"Drug: Adapalene + Clindamycin Hydrochloride","description":"0.1% Adapalene + 1% Clindamycin Hydrochloride"},{"intervention_type":"Drug","name":"Drug: Adapalene + Clindamycin Hydrochloride","description":"0.1% Adapalene + 2% Clindamycin Hydrochloride"},{"intervention_type":"Drug","name":"Drug: Adapalene + Clindamycin Hydrochloride","description":"0.05% Adapalene + 0.5% Clindamycin Hydrochloride"},{"intervention_type":"Drug","name":"Drug: Adapalene + Clindamycin Hydrochloride","description":"0.05% Adapalene + 1% Clindamycin Hydrochloride"},{"intervention_type":"Drug","name":"Drug: Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"efficacy endpoint","time_frame":"12 weeks","description":"number of patients with deceased acne lesions at the treatment end (Day 85±3) in each group;"},{"outcome_type":"secondary","measure":"IGA classification change","time_frame":"12 weeks","description":"The improvement of IGA （investigator general Assess）Classification at the treatment end (Day 85±3) in each group"},{"outcome_type":"secondary","measure":"treatment success rate","time_frame":"12 weeks","description":"The treatment success rate at the treatment end (Day 85±3) in each group; calculation methods:number of patients with IGA assessment improved to level 0 to level 1/ total number of patients"},{"outcome_type":"secondary","measure":"PK","time_frame":"12 weeks","description":"AUC"},{"outcome_type":"secondary","measure":"PK","time_frame":"12 weeks","description":"peak plasma concentration"}]}
{"nct_id":"NCT03602209","start_date":"2015-03-01","phase":"N/A","enrollment":120,"brief_title":"Short vs. Long Antibiotic Treatment of Implant-free Osteoarticular Infections","official_title":"Short vs. Long Antibiotic Treatment of Implant-free Osteoarticular Infections","primary_completion_date":"2018-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-05-18","last_update":"2018-08-01","description":"The investigators tested the working hypothesis if 4 weeks of systemic antibiotic treatment in implant-related orthopaedic infections is non-inferior to 6 weeks after complete removal of the infected implant. Randomization 1:1. The study is completed. It halted prematurely and will not resume; participants are no longer being examined or receiving intervention.","other_id":"No. 14-198","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":120,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adult patients (17 years old)\r\n\r\n          -  Total removal of the implant\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Primary native joint septic arthritis;\r\n\r\n          -  Co-trimoxazole prophylaxis because of immunosuppression;\r\n\r\n          -  Left-side endocarditis;\r\n\r\n          -  Persistent implant material in the infected area.\r\n\r\n          -  Infections with tuberculosis; mycobacteria; fungi; brucellosis; borreliosis;\r\n             nocardiosis; and mycoplasmal osteosynthesis infections\r\n      ","sponsor":"University Hospital, Geneva","sponsor_type":"Other","conditions":"Implant Infection","interventions":[{"intervention_type":"Procedure","name":"Procedure: Removal of infected implant"},{"intervention_type":"Drug","name":"Drug: Antibiotic durations"}],"outcomes":[{"outcome_type":"primary","measure":"Remission of infection","time_frame":"12 months","description":"Clinical evaluation"},{"outcome_type":"primary","measure":"Adverse events","time_frame":"12 months","description":"Clinical adverse events"}]}
{"nct_id":"NCT02374892","start_date":"2015-03-01","phase":"N/A","enrollment":60,"brief_title":"The CHAPTER III Study of Young Adolescents","official_title":"The CHAPTER III Study of Young Adolescents: Congenital Heart Adolescents Participating in Transition Evaluation Research","primary_completion_date":"2018-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-12-31","last_update":"2019-04-25","description":"The CHAPTER III Study (Congenital Heart Adolescents Participating in Transition Evaluation Research) is a cluster randomized controlled trial evaluating the impact of a nurse-led transition intervention in combination with usual care, versus usual care alone, on preparing adolescents with congenital heart disease (CHD) to successfully transition from pediatric to adult cardiology care. The Canadian Pediatric Society and American Academy of Pediatrics have recommended that transition interventions begin in early adolescence. Therefore, the investigators propose to conduct a nurse-led intervention that addresses the educational needs of 13-14 year olds.","other_id":"The CHAPTER III Study","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":13,"maximum_age":14,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        (i) moderate or complex CHD (as defined by the 2001 Bethesda Guidelines) (ii) followed at\r\n        the Stollery Children's Hospital\r\n\r\n        Exclusion Criteria:\r\n\r\n        (i) less than a Grade 6 level of reading and comprehension, based on parent report (ii)\r\n        heart transplantation, as this results in distinct health challenges\r\n      ","sponsor":"University of Alberta","sponsor_type":"Other","conditions":"Heart Defects, Congenital","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: CHAPTER III Study Intervention","description":"This will involve a 60 minute interaction between the adolescent and a cardiology nurse. A MyHealth passport will be created covering the name of the adolescents' cardiac condition, previous cardiac interventions, and name and purpose of the teen's medications. Potential late cardiac complications will be discussed. The adolescent and nurse will watch videos on talking to various health professionals. The adolescent will be given a study email address and encouraged to contact the nurse by email or text messaging with follow-up"}],"outcomes":[{"outcome_type":"primary","measure":"TRANSITION-Q Questionnaires","time_frame":"6 Months","description":"Change in TRANSITION-Q Questionnaire score between baseline, 1 month, and 6-months post enrollment."},{"outcome_type":"secondary","measure":"MyHeart Scale","time_frame":"6 Months","description":"Change in knowledge of their heart (MyHeart score) between baseline, 1 month and 6-months post enrollment."}]}
{"nct_id":"NCT02360085","start_date":"2015-02-28","enrollment":65,"brief_title":"Does Heart Rate Variablity (HRV) Predict Hypotension in Patients Undergoing Cervical Myelopathy Surgery ?","official_title":"Does Heart Rate Variablity (HRV) Predict Hypotension on Induction in Patients Undergoing Surgery for Cervical Myelopathy ?","primary_completion_date":"2019-10-31","study_type":"Observational","rec_status":"Completed","completion_date":"2020-04-30","last_update":"2021-01-06","description":"Cervical myelopathy is commonly associated with degenerative spinal disease. Dysfunction of the autonomic nervous system is also evident in many cases of cervical myelopathy. Autonomic dysfunction may result in haemodynamic instability and hypotension under anaesthesia. It is important to maintain adequate mean arterial pressure in order to perfuse the spinal cord and prevent cord ischemia. Heart rate variability, the physiological variations of the differences between heart beats, has been used to diagnose autonomic dysfunction. In patients with cervical myelopathy it may enable the anaesthetist to predict hypotension thereby allowing for early treatment and prevention of spinal cord ischemia.","other_id":"UHN REB # 14-8164","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients with cervical myelopathy presenting for cervical spine surgery at Toronto Western\r\n        Hospital.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adults patients, aged 18 - 70 years with the history of cervical myelopathy,\r\n             presenting for anterior or posterior cervical decompression and fusion.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients with arrhythmias or absence of sinus rhythm\r\n\r\n          2. Diabetic patients\r\n\r\n          3. Degenerative neurological disease e.g. Parkinson's disease\r\n\r\n          4. Complete SCI\r\n\r\n          5. Inherited autonomic dysfunction\r\n      ","sponsor":"Lashmi Venkatraghavan","sponsor_type":"Other","conditions":"Heart Rate Variability","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Mean Arterial Pressure","time_frame":"one day","description":"Preoperative Analysis Mean Arterial Pressure between hypotension group and no hypotension group"},{"outcome_type":"primary","measure":"HRV Indices Analysis","time_frame":"One day","description":"Low frequency (LF)/High frequency Ratio"},{"outcome_type":"primary","measure":"Heart Rate Variability (HRV)","time_frame":"1 day","description":"Difference between total power (ms2) of patients in the hypotension group compared to stable group"},{"outcome_type":"primary","measure":"HRV Indices","time_frame":"1 day","description":"Differences in HRV indices between hypotension group and no hypotension group"}]}
{"nct_id":"NCT02157025","start_date":"2015-02-28","phase":"N/A","enrollment":20,"brief_title":"A More Engaging Visual Field Test to Increase Use and Reliability in Pediatrics","official_title":"A More Engaging Visual Field Test to Increase Use and Reliability in Pediatrics","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-12-31","last_update":"2021-03-04","description":"The majority of young children do not think that visual field (VF) testing of peripheral vision is similar to a game; therefore, it is not surprising that they have difficulty maintaining attention during VF testing and thus the test reliability suffers as a consequence. Poor VF reliability has been a longstanding, major issue since it leads to an increased number of tests and/or longer duration of time needed to determine when there are true vision losses. Providers are less likely to obtain VF tests in children since the results are of doubtful value and challenging to interpret when they are inconsistent. Effectively this means that children with untreated, slowly progressive eye diseases may go undiagnosed and incur greater visual losses. The investigators aim to create a prototype device that the investigators hypothesize will make VF testing more engaging for young children, thus increasing their attention and consistency of their responses to the test stimuli, which in turn should improve VF reliability. The components include a microdisplay video screen (1.5\" diameter) as the fixation target (instead of the standard LED light) displaying video clips of popular cartoon characters, and audio clips of impersonated cartoon character voices presented by the test operator to provide instructional feedback based on the child's performance during testing. Improved VF reliability from the investigators intervention would translate to improved diagnosis and care for young childrens' peripheral vision loss through widespread implementation of the investigators innovative, affordable and readily adoptable system at eye care providers' offices.","other_id":"KID_VF","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":5,"maximum_age":8,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Ages 5-8\r\n\r\n          -  Seen previously in the clinics at Nova Southeastern University's The Eye Care\r\n             Institute with a diagnosis for glaucoma suspect or optic nerve abnormalities\r\n\r\n          -  Able and willing to complete VF testing at 2 study visits about a week apart\r\n\r\n          -  Provide informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of having previously completed a VF test using Humphrey static perimetry\r\n\r\n          -  Inability to understand study or communicate responses (cognitive impairment)\r\n\r\n          -  Unable to understand, read and speak English fluently\r\n      ","sponsor":"Nova Southeastern University","sponsor_type":"Other","conditions":"Glaucoma, Suspect|Optic Nerve Hypoplasia and Abnormalities of the Central Nervous System|Congenital Coloboma of the Optic Nerve|Optic Nerve Head Pits, Bilateral Congenital","interventions":[{"intervention_type":"Device","name":"Device: Cartoon video fixation target and cartoon character voice audio instructions during Humphrey perimetry"},{"intervention_type":"Other","name":"Other: Usual Care procedures during Humphrey perimetry for children"}],"outcomes":[{"outcome_type":"primary","measure":"Humphrey Visual Field Test-Retest Variability of Mean Deviation scores (dB)","time_frame":"1 week","description":"Within subject, the investigators will determine the coefficient of variation in the mean deviation scores obtained at the two sessions a week apart (dB). The investigators will test for significant differences between subjects who receive the intervention versus the usual care control group for the test-retest variability."},{"outcome_type":"secondary","measure":"Humphrey Visual Field Reliability Indices and Ratings","time_frame":"1 week","description":"The investigators will test for significant differences between subjects who receive the intervention versus the usual care control group for the visual field reliability criteria (false negatives, false positives and fixation losses; expressed as %), and operator ratings (subjects' fixation, cooperation and fatigue; scale 1 to 5)."}]}
{"nct_id":"NCT02659904","start_date":"2015-02-28","phase":"Early Phase 1","enrollment":40,"brief_title":"The Quantitative Changes in Palatal Donor Sites Thickness After Free Gingival Graft Harvesting","official_title":"The Quantitative Changes in Palatal Donor Sites Thickness After Free Gingival Graft Harvesting","primary_completion_date":"2015-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-01-31","last_update":"2016-01-21","description":"Our primary objective in this clinical intervention study, therefore, was to explored the effect of residual tissue thickness on the palatal mucosa healing from baseline to 1, 3 and 6 months after free gingival graft harvesting in order to determine as soon as possible to re-harvest gingival graft from same site.","other_id":"2015/103","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":35,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  All individuals received oral hygiene instructions and full-mouth scaling was\r\n             performed. -They were instructed to perform a non-traumatic brushing technique (Roll)\r\n             using an ultra-soft toothbrush\r\n\r\n          -  Individuals were re-evaluated at 8 weeks after initial therapy, and only full mounth\r\n             plaque score and full mounth bleeding score <15% were enrolled to the surgical\r\n             procedure\r\n\r\n          -  mucogingival defects which for soft tissue graft application were indicated\r\n\r\n          -  For Less than 2 mm group, between 2.5 and 3.4 mm palatal thickness at each measurement\r\n             points before graft harvesting\r\n\r\n          -  For 2 mm or more group, between 3.5 and 4.4 mm palatal thickness at each measurement\r\n             points before graft harvesting.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  periapical or palatal pathologies,\r\n\r\n          -  absence teeth from canine to first molar,\r\n\r\n          -  excessive forces including mechanical forces from orthodontics and occlusion,\r\n\r\n          -  systemic diseases that would contraindicate for periodontal surgery or interfere with\r\n             tissue healing, chronic high-dose steroid therapy, radiation or immunosuppressive\r\n             therapy, pregnancy, lactation, smoking, or allergy or sensitivity to any drug\r\n\r\n          -  Study participants had no history of drug therapy known to interfere with healing and\r\n             to cause gingival enlargement\r\n\r\n          -  Individuals who had complication such as bleeding, necrosis and delay healing during\r\n             or after surgery were excluded from the study.\r\n      ","sponsor":"lker KESKINER","sponsor_type":"Other","conditions":"Healthy|Gingival Recession","interventions":[{"intervention_type":"Other","name":"Other: Less than 2 mm remaining palatal tissue thickness","description":"The greater palatine and incisive nerves were blocked with 2% lidocaine, 1:100,000 epinephrine injection. After preparation of the recipient bed, free gingival graft was harvested using a handle with knife at palatal donor side with acrylic stent guidance."},{"intervention_type":"Other","name":"Other: 2 mm or more remaining palatal tissue thickness","description":"The greater palatine and incisive nerves were blocked with 2% lidocaine, 1:100,000 epinephrine injection. After preparation of the recipient bed, free gingival graft was harvested using a handle with knife at palatal donor side with acrylic stent guidance."}],"outcomes":[{"outcome_type":"primary","measure":"Change in remaining palatal tissue thickness","time_frame":"From baseline remaining palatal tissue thickness to post-operative 1, 3, 6 months"}]}
{"nct_id":"NCT02351089","start_date":"2015-02-28","phase":"N/A","enrollment":97,"brief_title":"Probiotics in Radiation-treated Gynecologic Cancer","official_title":"Probiotics in Radiation-treated Gynecologic Cancer","primary_completion_date":"2018-12-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2019-12-31","last_update":"2020-03-05","description":"The aim of the current Project is to study the efficacy of a probiotic Product in reducing the symptoms of gastrointestinal toxicity linked to the irradiation of gynecologic cancer.","other_id":"ProRad","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Quadruple","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Women diagnosed with cancer in the small pelvis and waiting to receive radiotherapy\r\n             either as a primary or as a secondary treatment following surgery. Chemotherapy may or\r\n             may not be part of the treatment regimen.\r\n\r\n          -  Age, older than 18 years old.\r\n\r\n          -  Agreement for participation in the study by signed written informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Previously treated with irradiation of the pelvic area.\r\n\r\n          -  Reluctance to refrain from using other probiotic products during the participation in\r\n             the study.\r\n      ","sponsor":"Probi AB","sponsor_type":"Industry","conditions":"Gastrointestinal Toxicity|Gynecologic Cancer","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Capsules placebo","description":"Capsules"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Capsules probiotic powder and corn starch"}],"outcomes":[{"outcome_type":"primary","measure":"Change in incidence of loose/watery stools","time_frame":"Baseline and 10 weeks later"}]}
{"nct_id":"NCT02351037","start_date":"2015-02-28","phase":"Phase 2","enrollment":36,"brief_title":"Study of Ibrutinib in Subjects With Acute Myeloid Leukemia","official_title":"A Multicenter Open-Label Phase 2a Study of Ibrutinib Monotherapy or in Combination With Either Cytarabine or Azacitidine in Subjects With Acute Myeloid Leukemia","primary_completion_date":"2017-04-30","study_type":"Interventional","rec_status":"Terminated","completion_date":"2017-04-30","last_update":"2018-08-14","description":"The purpose of this study is to evaluate the efficacy, safety and tolerability of ibrutinib alone or in combination with either cytarabine or azacitidine in the treatment of subjects with Acute Myeloid Leukemia (AML) who have failed standard treatment, or subjects without prior therapy who refuse standard chemotherapy.","other_id":"PCYC-1131-CA","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male and female  18 years of age.\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\r\n\r\n          -  Subjects with pathologically documented AML that has failed standard treatment, or\r\n             subjects without prior therapy who refuse standard treatment options\r\n\r\n          -  Bone marrow aspirate/biopsy results showing >5% blasts\r\n\r\n          -  WBC count <25,000 cells/mm3 (25 x 109/L)\r\n\r\n          -  Platelet count >10,000 cells/mm3 (10 x 109/L)\r\n\r\n          -  Adequate hepatic and renal function defined as:\r\n\r\n               -  For Cohorts 1 and 2: serum aspartate transaminase (AST) or alanine transaminase\r\n                  (ALT) 3.0 x upper limit of normal (ULN); for Cohort 3: ALT 2.5 or AST 2.5 ULN.\r\n\r\n               -  Serum creatinine 2 mg/dL or Estimated Creatinine Clearance 30 mL/min\r\n                  (Cockcroft-Gault).\r\n\r\n               -  Bilirubin 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of\r\n                  non-hepatic origin).\r\n\r\n          -  PT/INR <1.5 x ULN and PTT (aPTT) <1.5 x ULN (When treated with warfarin or other\r\n             vitamin K antagonists, then INR 3.0).\r\n\r\n          -  Female subjects who are of non-reproductive potential (Female subjects of reproductive\r\n             potential must have a negative serum pregnancy test upon study entry).\r\n\r\n          -  Male and female subjects of reproductive potential agree to use highly effective\r\n             methods of birth control (e.g., condoms, implants, injectables, combined oral\r\n             contraceptives, some intrauterine devices [IUDs], complete abstinence, or sterilized\r\n             partner) during the period of therapy and for 90 days after the last dose of study\r\n             drug.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Acute promyelocytic leukemia (French-American-British Class M3 AML).\r\n\r\n          -  Known active central nervous system (CNS) leukemia.\r\n\r\n          -  Known active systemic infection (Grade 2).\r\n\r\n          -  Active bleeding disorders or clinical signs of bleeding (Grade 2).\r\n\r\n          -  Prior bone marrow transplant that requires immunosuppressant therapy or presents with\r\n             graft vs host disease (GVHD).\r\n\r\n          -  History of other malignancies, except:\r\n\r\n               -  Malignancy treated with curative intent and with no known active disease present\r\n                  for 3 years before the first dose of study drug and with low risk of recurrence\r\n                  by treating physician.\r\n\r\n               -  Adequately treated non-melanoma skin cancer or lentigo maligna without evidence\r\n                  of disease.\r\n\r\n               -  Adequately treated carcinoma in situ without evidence of disease.\r\n\r\n          -  Prior treatment with a BTK inhibitor.\r\n\r\n          -  For Cohort 3 subjects, prior treatment with hypomethylating agents (eg, azacitidine,\r\n             decitabine)\r\n\r\n          -  Anticancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal or\r\n             any investigational therapy within 14 days or 5 half-lives (whichever is shorter)\r\n             prior to first dose of study drug.\r\n\r\n          -  Subject has received a monoclonal antibody for anticancer intent within 8 weeks prior\r\n             to the first dose of study drug.\r\n\r\n          -  Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug.\r\n\r\n          -  Recent infection requiring intravenous (IV) systemic treatment that was completed 14\r\n             days before the first dose of study drug.\r\n\r\n          -  Unresolved toxicities from prior anticancer therapy, defined as having not resolved to\r\n             Common Terminology Criteria for Adverse Event (CTCAE, version 4.03), Grade 0 or 1,\r\n             unless otherwise defined in the inclusion/exclusion criteria with the exception of\r\n             alopecia.\r\n\r\n          -  Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia.\r\n\r\n          -  History of stroke or intracranial hemorrhage within 6 months prior to enrollment.\r\n\r\n          -  Known history of human immunodeficiency virus (HIV) or active with hepatitis C virus\r\n             (HCV) or hepatitis B virus (HBV). Subjects who are positive for hepatitis B core\r\n             antibody or hepatitis B surface antigen must have a negative polymerase chain reaction\r\n             (PCR) result before enrollment. Those who are PCR positive will be excluded.\r\n\r\n          -  Major surgery within 4 weeks of first dose of study drug.\r\n\r\n          -  Any life-threatening illness, medical condition, or organ system dysfunction that, in\r\n             the investigator's opinion, could compromise the subject's safety or put the study\r\n             outcomes at undue risk.\r\n\r\n          -  Currently active, clinically significant cardiovascular disease, such as uncontrolled\r\n             arrhythmia or Class 3 or 4 congestive heart failure as defined by the New York Heart\r\n             Association Functional Classification; or a history of myocardial infarction, unstable\r\n             angina, or acute coronary syndrome within 6 months prior to randomization.\r\n\r\n          -  Unable to swallow capsules or malabsorption syndrome, disease significantly affecting\r\n             gastrointestinal function, or resection of the stomach or small bowel, symptomatic\r\n             inflammatory bowel disease or ulcerative colitis, or partial or complete bowel\r\n             obstruction.\r\n\r\n          -  Concomitant use of warfarin or other Vitamin K antagonists.\r\n\r\n          -  Requires treatment or prophylaxis with a strong cytochrome P450 (CYP) 3A inhibitor\r\n\r\n          -  Currently active, clinically significant hepatic impairment ( moderate hepatic\r\n             impairment according to the Child Pugh classification).\r\n\r\n          -  Lactating or pregnant.\r\n\r\n          -  Unwilling or unable to participate in all required study evaluations and procedures.\r\n\r\n          -  Unable to understand the purpose and risks of the study and to provide a signed and\r\n             dated informed consent form (ICF) and authorization to use protected health\r\n             information (in accordance with national and local subject privacy regulations).\r\n      ","sponsor":"Pharmacyclics LLC.","sponsor_type":"Industry","conditions":"Acute Myeloid Leukemia (AML)","interventions":[{"intervention_type":"Drug","name":"Drug: Ibrutinib","description":"Subjects will receive ibrutinib 560 mg once daily on a continuing basis."},{"intervention_type":"Drug","name":"Drug: Ibrutinib + LD-AraC","description":"Subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 2 days prior to first cytarabine dose (20 mg BID sc) for 10 days of a 28-day cycle."},{"intervention_type":"Drug","name":"Drug: Ibrutinib+Azacitidine","description":"Subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 1 day prior to first azacitidine dose + azacitidine 75 mg/m2 IV once daily on Days 1-7 of a 28-day cycle (with an option to increase to 100 mg/m2 after 2 cycles)."}],"outcomes":[{"outcome_type":"primary","measure":"Efficacy of Ibrutinib Monotherapy or in Combination With Either LD-AraC or Azacitidine Using the Overall Remission Rate (Defined as Proportion of Subjects Achieving a CR or CRi) According to the LeukemiaNet Guidelines","time_frame":"When the last subject enrolled completes approximately 12 months of treatment.","description":"Dohner's 2000 Criteria for AML: Complete Response (CR), Bone marrow blasts < 5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count > 1.0 x 109/L (1000/µL); platelet count >100 x 109/L (100 000/µL); independence of red cell transfusions; CR with Incomplete Recovery (CRi), All CR criteria except for residual neutropenia (< 1.0 x 109/L [1000/µL]) or thrombocytopenia (<100 x 109/L [100 000/µL]) ; Morphologic leukemia-free state, Bone marrow blasts < 5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required; Partial Remission (PR), All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%; Relapse, Bone marrow blasts > 5%; or reappearance of blasts in the blood; or development of extramedullary disease."},{"outcome_type":"primary","measure":"Safety and Tolerability of Ibrutinib Monotherapy or in Combination With Either LD-AraC or Azacitidine","time_frame":"Up to 30 days following the last dose of study drug.","description":"Number of Participants with Adverse Events and number of patients with lab abnormalities.The safety profile of ibrutinib was evaluated based on the incidence of adverse events (AEs) as well as clinically significant laboratory abnormalities and vital signs, and other malignancies. The safety evaluations performed in this study were standard and/or were required based on the safety data available from other clinical and preclinical settings."},{"outcome_type":"secondary","measure":"Relapse-free Survival (RFS), Event-free Survival (EFS) and Overall Survival (OS)","time_frame":"When the last subject enrolled completes approximately 12 months of treatment","description":"To evaluate clinical efficacy by assessing relapse-free survival (RFS), event-free survival (EFS) and overall survival (OS)."},{"outcome_type":"secondary","measure":"Clinical Benefit Rate - as Defined as the Proportion of Subjects Who Achieve CR, CRi, Morphologic Leukemia-free State, or Partial Remission (PR)","time_frame":"When the last subject enrolled completes approximately 12 months of treatment","description":"To evaluate clinical benefit defined as CR, CRi, morphologic leukemia-free state, and partial remission (PR)."}]}
{"nct_id":"NCT02659085","start_date":"2015-02-28","phase":"Phase 2/Phase 3","enrollment":198,"brief_title":"Ketamine as an Alternative Treatment to ECT in Major Depressive Disorder","official_title":"A Randomized Controlled Non-inferiority Trial Comparing Ketamine With ECT in Patients With Major Depressive Disorder","primary_completion_date":"2019-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-08-31","last_update":"2019-12-19","description":"Developing more effective and faster acting antidepressant is of outmost clinical importance. Available antidepressant therapies have a delayed therapeutic effect. It typically takes several weeks before symptom relief is evident. Furthermore, antidepressants are relatively ineffective - as many as 30% of patients do not respond to any medication at all. In this study the investigators evaluate the NMDA-receptor antagonist ketamine as a potentially new antidepressant treatment for severely depressed patients and compare its effectiveness with that of electroconvulsive therapy (ECT).","other_id":"2011-001520-37","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Aged 18-85\r\n\r\n          -  Diagnosed with major depressive disorder (MDD, according to DSM-IV)\r\n\r\n          -  Inpatients who have been offered and have accepted ECT\r\n\r\n          -  Are eligible to participate\r\n\r\n          -  Score  20 Points on Montgomery sberg Depression Rating Scale (MADRS)\r\n\r\n          -  Must be proficient in spoken and written Swedish\r\n\r\n          -  American Society of Anaesthesiologists physical status classification (ASA) 1-3\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Co-morbid conditions that could interfere with the treatment (e.g. primary psychosis)\r\n\r\n          -  Habitual difficulties to speak, hear, remember or reason\r\n\r\n          -  Treatment according to LPT (Lagen om psykiatrisk tvngsvrd; Compulsory Psychiatric\r\n             Care Act)\r\n\r\n          -  On-going or recent (6 months) drug abuse\r\n\r\n          -  Known allergy to the active substance\r\n\r\n          -  Pregnant or breastfeeding women\r\n\r\n          -  Known cardiovascular disease, including angina, acute/chronic congestive heart\r\n             failure, moderly hypertension or tachyarrhythmia (because exacerbation by\r\n             sympathomimetic properties of ketamine)\r\n\r\n          -  Pathological conditions in central nervous system with risk of increased intracranial\r\n             pressure (increased ICP with ketamine)\r\n\r\n          -  Glaucoma (increased IOP with ketamine)\r\n\r\n          -  Porphyria or thyroid disorder (enhanced sympathomimetic properties by ketamine)\r\n\r\n          -  Ongoing severe infection\r\n      ","sponsor":"Pouya Movahed Rad","sponsor_type":"Other","conditions":"Depressive Disorder, Major","interventions":[{"intervention_type":"Drug","name":"Drug: Ketamine IV Infusion","description":"Patients randomized to the experimental treatment receive intravenous infusions of racemic ketamine (0.5 mg/kg), delivered over a period of forty minutes thrice weekly (Monday, Wednesday, Friday) under supervision."},{"intervention_type":"Procedure","name":"Procedure: ECT","description":"ECT given in line with standard procedures (including anesthesia, muscle relaxation and oxygenation) thrice weekly."}],"outcomes":[{"outcome_type":"primary","measure":"Proportion of patients in remission in each treatment arm assessed by Montgomery-Asberg Depression Rating Scale (MADRS)","time_frame":"Follow up of one year after treatment cessation","description":"Primary outcome is the proportion of patients in remission in each treatment arm. Remission is defined as a MADRS ≤ 10."},{"outcome_type":"secondary","measure":"Time to remission compared between the two treatments.","time_frame":"The MADRS score is measured for a maximum of 4 weeks.","description":"Time (days) to reach remission (defined as MADRS≤ 10) is compared between the groups."},{"outcome_type":"secondary","measure":"Time to response compared between the two treatments.","time_frame":"The MADRS score is measured for a maximum of 4 weeks.","description":"Time (days) to response (defined as a drop of 50% from the pre-treatment MADRS value)) is compared between the groups."},{"outcome_type":"secondary","measure":"Ketamine treatment is associated with a smaller decrease in the performance in a CANTAB cognitive test battery compared to ECT.","time_frame":"Assessed prior to the first treatment, after two weeks, within one week after remission and at three additional time points (3, 6 and 12 months) after conclusion of the treatment.","description":"Cognitive function are assessed with Cambridge Automated Neuropsychological Test Automated Battery (CANTAB)."},{"outcome_type":"secondary","measure":"Remission from severe depression is associated with improved performance in the performance in a CANTAB cognitive test battery.","time_frame":"Assessed prior to the first treatment, after two weeks, within one week after remission and at three additional time points (3, 6 and 12 months) after conclusion of the treatment.","description":"Cognitive function are assessed with Cambridge Automated Neuropsychological Test Automated Battery (CANTAB)."},{"outcome_type":"secondary","measure":"The antidepressant effect of ketamine is longer lasting than that of ECT, assessed by the proportion of patients in remission (defined by a maximum score of 9 in the Montgomery-Asberg Depression Rating Scale (MADRS)).","time_frame":"Within one week after remission and at three additional time points (3, 6 and 12 months) after remission","description":"The antidepressant effect will be assessed with MADRS baseline score and measured within one week after remission and at three additional time points (3, 6 and 12 months) after conclusion of the treatment."},{"outcome_type":"secondary","measure":"Ketamine treatment is associated with a smaller decrease in the performance in Rey Auditory Verbal Learning Test (RAVLT) compared to ECT.","time_frame":"Assessed prior to the first treatment, after two weeks, within one week after remission and at three additional time points (3, 6 and 12 months) after conclusion of the treatment.","description":"Reys Auditory Verbal Learning Test (RAVLT)"},{"outcome_type":"secondary","measure":"Remission from severe depression is associated with improved performance in the performance in Rey Auditory Verbal Learning Test (RAVLT).","time_frame":"Assessed prior to the first treatment, after two weeks, within one week after remission and at three additional time points (3, 6 and 12 months) after conclusion of the treatment.","description":"Reys Auditory Verbal Learning Test (RAVLT)"}]}
{"nct_id":"NCT03162003","start_date":"2015-02-28","enrollment":55,"brief_title":"Irish Programme for Stratified Prostate Cancer Therapy","official_title":"Irish Programme for Stratified Prostate Cancer Therapy","primary_completion_date":"2020-08-31","study_type":"Observational","rec_status":"Completed","last_update":"2020-11-17","description":"The purpose of the trial is to investigate new clinical tests that could predict what treatments work best for certain patients with advanced prostate cancer by identifying markers and indicators present in blood and tissue which correlate with treatment response.","other_id":"CTRIAL-IE (ICORG) 14-04","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"Male","minimum_age":18,"population":"Men with castrate sensitive (cohort 1) or castrate resistant (cohort 2) metastatic prostate\r\n        cancer.","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Stage 4 mPCa as confirmed by CT/MRI or by bone scan\r\n\r\n          2. Patient with visceral disease and/or bone lesions (excluding patients who only have\r\n             nodal disease), who have commenced or are about to commence ADT and whose disease has\r\n             not shown any evidence of castration resistance (cohort 1) Or Patient with\r\n             castrate-resistant disease at time of treatment change (cohort 2)\r\n\r\n          3. Stable medical condition, including the absence of acute exacerbations of chronic\r\n             illnesses, serious infections, or major surgery within 28 days prior to recruitment\r\n\r\n          4. Life expectancy of at least 6 months\r\n\r\n          5. Ability to give written informed consent obtained before any study-related procedures\r\n\r\n          6. Age  18 years and male\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Diagnosis of or treatment for another systemic malignancy within 2 years before study\r\n             entry.*\r\n\r\n          2. Any evidence of residual disease from a previously diagnosed malignancy. *Patients\r\n             with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if\r\n             they have undergone complete resection\r\n      ","sponsor":"Cancer Trials Ireland","sponsor_type":"Other","conditions":"Prostate Cancer","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Biomarkers of Androgen Deprivation Therapy (ADT) alone and combined.","time_frame":"10 years","description":"Identification of predictive biomarkers for ADT treatment or ADT combined treatment response in metastatic prostate cancer"},{"outcome_type":"primary","measure":"Biomarkers to treatment response","time_frame":"10 years","description":"Identification of predictive biomarker(s) for treatment response in metastatic castrate resistant prostate cancer"},{"outcome_type":"secondary","measure":"Circulating Tumour Cells (CTC's)","time_frame":"10 years","description":"Analysis of the biology of CTCs from metastatic prostate cancer patients."}]}
{"nct_id":"NCT02749448","start_date":"2015-02-28","phase":"Phase 1","enrollment":10,"brief_title":"Mesenchymal Stem Cells Therapy for Treatment of Airway Remodeling in Mustard Patients","official_title":"The Effect of Autologous Adipose Mesenchymal Stem Cells in Treatment of Airway Injury in Patients Exposed to Sulfur Mustard","primary_completion_date":"2016-11-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2017-02-28","last_update":"2016-07-25","description":"Background: Sulfur mustard (SM) is a potent alkylating agent that targets several organs, especially lung tissue. SM exposure leads to serious changes in morphological structure of airway system, which is associated with chronic obstructive pulmonary deficiency following exposure to SM. With extensive progress and achievements in tissue repair through stem cells therapy, consideration of lung tissue has been increased due to the high prevalence of pulmonary problems. Several factors such as selection of cell types, required conditions for growth and proliferation of stem cells, and the process of entering into the body to repair damaged lung tissue are considered as the most important problems in this issue. Accumulating studies, both in animals and human with mesenchymal stem cells (MSC) support the hypothesis of therapeutic effects of these cells in various disorders. In this study investigators aimed to evaluate safety and potential efficacy of systemic MSC administration for treatment of chronic lung injuries in SM-exposed patients. Methods: Patients will receive 100 million MSC cells every two months for three injections within 6 months. After each injection, parameters including safety, pulmonary function testing (PFT), quality-of-life indicators, 6 minute walk test (6MWT), and expression of inflammation and oxidative stress genes will be evaluated.","other_id":"IRCT2015110524890N1","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":45,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  patients who had a documentary exposure to mustard gas in the Iran-Iraq war\r\n\r\n          -  their disease severity were as following based on spirometric: moderate 50<forced\r\n             expiratory volume at one second (FEV1)<65 or severe 40<FEV1<50\r\n\r\n          -  absence of contraindications spirometry (recent myocardial ischemia (MI)\r\n\r\n          -  hemoptysis\r\n\r\n          -  cerebral arterial aneurysm or aortic\r\n\r\n          -  pulmonary embolism,\r\n\r\n          -  uncontrolled blood pressure\r\n\r\n          -  recent pneumothorax\r\n\r\n          -  no doubt surgery/recent thoracic\r\n\r\n          -  recent eye surgery, recent stroke\r\n\r\n          -  non-availability in another research study at a same time\r\n\r\n          -  no coagulation disorders\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  smoking\r\n\r\n          -  the incidence of pneumonia during the study\r\n\r\n          -  the incidence of transfusion reaction\r\n\r\n          -  other medical condition (cardiovascular disease, hypertension, diabetes)\r\n\r\n          -  visiting less than 2 times\r\n      ","sponsor":"Dr. Mostafa Ghanei","sponsor_type":"Other","conditions":"Pulmonary Disease","interventions":[{"intervention_type":"Other","name":"Other: mesenchymal stem cell","description":"There are complex sets of non-hematopoietic cells in bone marrow called mesenchymal progenitor cells (MPCs). MSCs are well-known as multipotent cells that have the ability to self-renew and differentiate into a great variety of cells. MSCs can be isolated from bone marrow, umbilical cord, peripheral blood and adipose tissue, and cultured in specific media. MSC colony formation, which is known as marrow-like stromal cells and MPCs, is similar to fibroblast colony forming unit (CFU-F) in in vitro condition. According to the International Society for Cellular Therapy (ISCT), MSCs can be easily detected or identified from other cells using flow cytometric analysis to detect specific surface markers"}],"outcomes":[{"outcome_type":"primary","measure":"pulmonary function testing (PFT)","time_frame":"one year","description":"Pulmonary Function Testing (PFT) is a complete evaluation of the respiratory system including patient history, physical examinations, chest x-ray examinations, arterial blood gas analysis, and tests of pulmonary function. The primary purpose of pulmonary function testing is to identify the severity of pulmonary impairment."},{"outcome_type":"secondary","measure":"St. George's Respiratory Questionnaire (SGRQ)","time_frame":"one year","description":"The SGRQ is designed to measure health impairment in patients with asthma and COPD. It is also valid for use in bronchiectasis and has been used successfully in SM patients"},{"outcome_type":"secondary","measure":"6 minute walk test (6MWT)","time_frame":"one year","description":"The original purpose of the six minute walk was to test exercise tolerance in chronic respiratory disease and heart failure."}]}
{"nct_id":"NCT02585518","start_date":"2015-02-28","enrollment":40,"brief_title":"Ecological Momentary Assessment of Eating Behavior in Overweight Youth","official_title":"Ecological Momentary Assessment of Eating Behavior in Overweight Youth","primary_completion_date":"2018-02-28","study_type":"Observational","rec_status":"Unknown status","completion_date":"2018-02-28","last_update":"2017-05-02","description":"The current study seeks to elucidate the context of pathological and non-pathological eating behavior in a heterogeneous sample of overweight and obese children, aged 8-14 years. Children will undergo a two-week ecological momentary assessment (EMA) protocol in which they record all eating episodes and their physiological, emotional, interpersonal, and environmental correlates. Specific aims are to identify proximal antecedents and consequences of pathological and non-pathological eating in overweight and obese children, and to determine the prevalence of loss of control eating in the natural environment.","other_id":"IRB14-1212","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":8,"maximum_age":14,"population":"Participants will comprise 40 overweight or obese (BMI85th %ile) youth aged 8-14 years.\r\n        Every effort will be made to recruit a racially/ethnically diverse sample. Participants\r\n        will be excluded if they 1) are currently taking any medications known to affect weight or\r\n        appetite (e.g., antidepressants, steroids, chemotherapy drugs); 2) have a current or past\r\n        diagnosis of an eating disorder involving purging or suppressed body weight (e.g., bulimia\r\n        nervosa or anorexia nervosa); 3) are unable to read and understand English fluently; or 4)\r\n        are receiving concurrent treatment for obesity.","criteria":"\n        Inclusion Criteria:\r\n\r\n        Participants be included if they are overweight or obese (BMI85th %ile) and aged 8-14\r\n        years.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Participants will be excluded if they 1) are currently taking any medications known to\r\n        affect weight or appetite (e.g., antidepressants, steroids, chemotherapy drugs); 2) have a\r\n        current or past diagnosis of an eating disorder involving purging or suppressed body weight\r\n        (e.g., bulimia nervosa or anorexia nervosa); 3) are unable to read and understand English\r\n        fluently; or 4) are receiving concurrent treatment for obesity.\r\n      ","sponsor":"University of Chicago","sponsor_type":"Other","conditions":"Obesity","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Eating episodes","time_frame":"Repeated measures throughout the 2-week EMA protocol"}]}
{"nct_id":"NCT02421302","start_date":"2015-02-28","phase":"N/A","enrollment":150,"brief_title":"The Pediatric HIV Nutrition Study in Uganda","official_title":"The Role of Nutrition as a Determinant of Immune Function and Pharmacological Outcome Amongst HIV Infected Malnourished Children in Uganda","primary_completion_date":"2015-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2016-04-30","last_update":"2015-04-20","description":"This will be cohort study design with both qualitative and quantitative methods of data collection. The investigators are aiming to study 64 HIV positive children as healthy controls either initiating ART or already on ART and 86 malnourished HIV infected children on ART or nave initiating ART and RUTF aged between 6 months to 12 years. Primary carers will be asked to provide informed consent whereby the children and primary carers will be enrolled into the study and followed up for 12 weeks.","other_id":"ST/0110/15","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":0.5,"maximum_age":12,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  HIV-infected children aged 6 months to 12 years, including Well Nourished (WN),\r\n             Moderately Acute Malnutrition (MAM) and Severe Acute Malnutrition (SAM) patients\r\n             initiating on ART within 2 weeks, whose carer is aged 18 years and has provided\r\n             informed consent.\r\n\r\n          -  Malnourished HIV-infected children aged 6 months to 12 years stabilized on ART for at\r\n             least 6 months and initiating on RUTF, whose carer is aged 18 years and has provided\r\n             informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Previous enrollment in a nutritional therapeutic program in the last 3 months\r\n\r\n          2. Children involved in an on-going nutrition study\r\n\r\n          3. Children who have previously received the tuberculin skin test (TST) or mantoux or\r\n             purified protein derivative (PPD) in the last 3 months.\r\n\r\n          4. Children with clinically suspected or confirmed malignancy\r\n\r\n          5. Children exhibiting any specific food intolerance\r\n\r\n          6. Children who are vomiting profusely (over 3 times daily)\r\n\r\n          7. Children living outside 50 km radius from Infectious Diseases Institute at Mulago,\r\n             Kampala\r\n\r\n          8. Children whose carers do not want to disclose their home address.\r\n\r\n          9. Children whose cause of malnutrition is compounded by congenital malformations,\r\n             chromosomal disorders, metabolic disorders, congenital immune disorders, cerebral\r\n             palsy\r\n\r\n         10. Children with a severe disability limiting the possibility of investigations\r\n\r\n         11. Children who plan to leave the catchment area in the next 6 months\r\n      ","sponsor":"Infectious Diseases Institute","sponsor_type":"Other","conditions":"Child Nutrition Disorders","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: RUTF","description":"This is ready-to-use-therapeutic-food"}],"outcomes":[{"outcome_type":"primary","measure":"Changes in numbers of circulating immune cell population and their capacity to release cytokines","time_frame":"12 weeks","description":"Immune response"},{"outcome_type":"secondary","measure":"Occurrence of Immune reconstitution inflammatory syndrome (IRIS)","time_frame":"12 weeks","description":"Episodes of Opportunistic infections - Clinical outcomes"},{"outcome_type":"secondary","measure":"Occurrence of re-feeding syndrome","time_frame":"12 weeks","description":"Episodes of Opportunistic infections - Clinical outcomes"},{"outcome_type":"secondary","measure":"Pharmacological: Cmax","time_frame":"12 weeks","description":"Cmax of Non-nucleotide reverse - transcriptase inhibitors (NNRTI) and Protease Inhibitors(PIs) at 0weeks, 6weeks,12weeks"},{"outcome_type":"secondary","measure":"Pharmacological: AUC","time_frame":"12 weeks","description":"Area Under Curve (AUC) Time Frame: 0weeks, 6weeks, 12weeks for nevirapine and lopinvir/retonavir"},{"outcome_type":"secondary","measure":"Number of participants with adverse events","time_frame":"12 weeks","description":"Pharmacological: Number of participants with adverse events"}]}
{"nct_id":"NCT02558803","start_date":"2015-02-28","phase":"N/A","enrollment":1305,"brief_title":"HPV Vaccination: Evaluation of Reminder Prompts for Doses 2 & 3","official_title":"HPV Vaccination: Evaluation of Reminder Prompts for Doses 2 & 3","primary_completion_date":"2016-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-05-31","last_update":"2016-05-25","description":"Randomized, 2-arm observational study. The 2 arms (randomized at the level of health care provider) will be: 1. usual practice; 2. automated reminders to recommend 2nd and 3rd doses of HPV vaccine for eligible male and female adolescents who have initiated vaccination.","other_id":"Merck 21","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":11,"maximum_age":17,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Provider Criteria\r\n\r\n          -  All pediatricians and nurse practitioners who provide health care at the 5 CHICA\r\n             clinics will be included in this study\r\n\r\n        Subject Criteria\r\n\r\n          -  Patients will be 11-17 year old\r\n\r\n          -  Males and females\r\n\r\n          -  A visit to at least one of the five CHICA clinics\r\n\r\n          -  Eligible for the 2nd or 3rd dose of HPV vaccine\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients in the eligible age range who have not started or have completed the HPV\r\n             vaccine series will be excluded\r\n      ","sponsor":"Regenstrief Institute, Inc.","sponsor_type":"Other","conditions":"Human Papilloma Virus Infection Type 11|Human Papilloma Virus Infection Type 16|Human Papilloma Virus Infection Type 18|Human Papilloma Virus Infection Type 6|Cervical Cancer|Genital Warts|Oropharyngeal Cancer","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Simple Reminder","description":"A simple reminder prompt in which CHICA will provide an immunization reminder to the physician that the child is eligible for the 2nd or 3rd dose of vaccine."}],"outcomes":[{"outcome_type":"primary","measure":"Rate of physician-targeted automated HPV vaccination reminders on 2nd and 3rd dose HPV vaccination rates among 11-17 year old male and female patients","time_frame":"Six Months","description":"To evaluate the rate of physician-targeted automated HPV vaccination reminders on 2nd and 3rd dose HPV vaccination rates among 11-17 year old male and female patients who have received 1 or 2 doses of vaccine."},{"outcome_type":"secondary","measure":"Assessment of Physician Acceptance of the Prompts","time_frame":"Six Months","description":"The study team will compare changes in vaccination rates with qualitative feedback from providers."}]}
{"nct_id":"NCT02466659","start_date":"2015-02-01","phase":"N/A","enrollment":8,"brief_title":"Controlled Intermittent Alternate Occlusion (CIAO) Therapy for Intermittent Exotropia","official_title":"A Clinical Trial of Observation Versus Controlled Intermittent Alternate Occlusion (CIAO) Therapy for Intermittent Exotropia","primary_completion_date":"2016-12-01","study_type":"Interventional","rec_status":"Terminated","completion_date":"2016-12-01","last_update":"2017-11-30","description":"To determine the effectiveness of alternate occlusion therapy for the treatment of IXT among patients aged 3 to < 11 years old.","other_id":"IndianU","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":3,"maximum_age":11,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Intermittent exotropia (manifest deviation) meeting all of the following criteria:\r\n\r\n               -  Intermittent exotropia at distance OR constant exotropia at distance and either\r\n                  intermittent exotropia or exophoria at near\r\n\r\n               -  Exodeviation at least 15PD at distance OR near measured by prism and alternate\r\n                  cover test (PACT)\r\n\r\n               -  Exodeviation at least 10PD at distance measured by PACT\r\n\r\n          -  No previous surgical or non-surgical treatment for IXT (other than refractive\r\n             correction)\r\n\r\n          -  Visual acuity in the worse eye 0.3 logMAR or better (20/40 on ATS HOTV or 70 letters\r\n             on E-ETDRS) for children  3 years of age\r\n\r\n          -  No interocular difference of visual acuity more than 0.2 logMAR (2 lines on ATS HOTV\r\n             or 10 letters on E-ETDRS) for children  7 years of age\r\n\r\n          -  Investigator not planning to initiate amblyopia treatment\r\n\r\n          -  No hyperopia greater than +3.50 D spherical equivalent in either eye\r\n\r\n          -  No myopia greater than -6.00 D spherical equivalent in either eye\r\n\r\n          -  No prior strabismus, intraocular, or refractive surgery\r\n\r\n          -  No abnormality of the cornea, lens, or central retina\r\n\r\n          -  Investigator willing to observe the IXT untreated for 3 years unless specific criteria\r\n             for deterioration are met.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  N/A\r\n      ","sponsor":"Indiana University School of Medicine","sponsor_type":"Other","conditions":"Intermittent Exotropia","interventions":[{"intervention_type":"Device","name":"Device: CIAO therapy Amblyz glasses","description":"3-hour CIAO Therapy Amblyz glasses"}],"outcomes":[{"outcome_type":"primary","measure":"Change in Composite Measure of IXT Control Score","time_frame":"12 weeks; 24 weeks","description":"IXT control score: referring to the Pediatric eye disease investigator group (PEDIG).\r\nPEDIG scale of control for IXT 1-5 is defined as the following:\r\n5 = Constant exotropia 4 = exotropia > 50% of the 30-sec period before dissociation 3 = exotropia < 50% of the 30-sec period before dissociation 2 = No exotropia unless dissociated, recovers in > 5 sec\r\n1 = No exotropia unless dissociated, recovers in 1-5 sec 0 = No exotropia unless dissociated, recovers in < 1 sec (phoria) Not Applicable = No exotropia present"},{"outcome_type":"other","measure":"Amblyopia","time_frame":"3 Months","description":"It is defined when visual acuity between two eyes equal or over 2 logMAR lines."}]}
{"nct_id":"NCT02334072","start_date":"2015-01-31","phase":"N/A","enrollment":100,"brief_title":"The Effects of Different Airway Devices on Middle Ear Pressure in Pediatric Patients","official_title":"The Effects of Different Airway Devices on Middle Ear Pressure in Pediatric Patients","primary_completion_date":"2015-08-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2015-09-30","last_update":"2015-06-23","description":"Even though the effects of anesthetic agents both inhalation and intravenous have been well described, the effect of laryngeal mask airways haven't. The purpose of the study is to determine the effects of different types of laryngeal mask airways on middle ear pressure.","other_id":"Adiyaman/LMA-MEP","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"All","maximum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Elective patients undergoing subumbilical surgery under general anesthesia\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Emergency conditions\r\n\r\n          -  Rejection of patient approval\r\n\r\n          -  Tympanic membrane perforation history\r\n\r\n          -  Anticipated difficult airway\r\n\r\n          -  Contraindications for LMA application\r\n      ","sponsor":"Adiyaman University Research Hospital","sponsor_type":"Other","conditions":"Local Pressure Effects|Simple Ear","interventions":[{"intervention_type":"Device","name":"Device: Laryngeal mask classical application","description":"Laryngeal mask classical application will be done following induction of anesthesia and anesthesia will be conducted by this device."},{"intervention_type":"Device","name":"Device: I-gel laryngeal mask application","description":"I-gel laryngeal mask application will be done following induction of anesthesia and anesthesia will be conducted by this device."},{"intervention_type":"Device","name":"Device: Cobra laryngeal mask application","description":"Cobra laryngeal mask application will be done following induction of anesthesia and anesthesia will be conducted by this device."},{"intervention_type":"Device","name":"Device: Supreme laryngeal mask application","description":"Supreme laryngeal mask application will be done following induction of anesthesia and anesthesia will be conducted by this device."},{"intervention_type":"Device","name":"Device: Proseal laryngeal mask application","description":"Proseal laryngeal mask application will be done following induction of anesthesia and anesthesia will be conducted by this device."}],"outcomes":[{"outcome_type":"primary","measure":"Middle ear pressure changes after the device application (MEP)","time_frame":"Perioperative"},{"outcome_type":"secondary","measure":"Composite Hemodynamics","time_frame":"Perioperative","description":"Heart rate,arterial blood pressure, haemoglobin saturation rate"}]}
{"nct_id":"NCT02322892","start_date":"2015-01-31","phase":"Phase 2","enrollment":64,"brief_title":"Thiamine as an Adjunctive Therapy in Cardiac Surgery","official_title":"Thiamine as an Adjunctive Therapy in Cardiac Surgery","primary_completion_date":"2015-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-08-31","last_update":"2017-03-30","description":"The main purpose of this pilot study is to test the effects of thiamine (vitamin B1) administration before and after major cardiac surgery. Half of patients will receive thiamine and the other half will receive placebo. The investigators' main hypothesis is that thiamine will improve cellular oxygen consumption and lead to decreased levels of post-operative lactate levels and ultimately improved patient outcomes.","other_id":"2014P000257","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":21,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adult ( 21 years)\r\n\r\n          -  Coronary artery bypass grafting (CABG) with or without concomitant valve procedures\r\n\r\n          -  EuroSCORE II > 1.5%\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Current thiamine supplementation\r\n\r\n          -  Known allergy to thiamine\r\n\r\n          -  Competing indication for thiamine administration as judged by the clinical team (e.g.,\r\n             alcoholic)\r\n\r\n          -  Research-protected populations (pregnant women, prisoners, the intellectually\r\n             disabled)\r\n\r\n          -  Emergent or salvage CABG (as defined by the Society of Thoracic Surgeons)\r\n\r\n          -  Off-pump surgery (i.e. surgery without cardiopulmonary bypass)\r\n      ","sponsor":"Beth Israel Deaconess Medical Center","sponsor_type":"Other","conditions":"Coronary Artery Bypass|Cardiac Surgical Procedures","interventions":[{"intervention_type":"Drug","name":"Drug: Thiamine","description":"200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"},{"intervention_type":"Drug","name":"Drug: Normal saline solution","description":"50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"}],"outcomes":[{"outcome_type":"primary","measure":"Lactate Levels","time_frame":"Post-surgery within 1 hour of arrival to the ICU"},{"outcome_type":"secondary","measure":"Percentage Change From Baseline in Pyruvate Dehydrogenase (PDH) Enzyme Activity","time_frame":"Post-surgery within 1 hour of arrival to the ICU","description":"PDH activity will be measured in isolated peripheral blood mononuclear cells using a novel immunocapture and microplate-based method. Reported as relative change from before the surgery."},{"outcome_type":"secondary","measure":"Patients With Post-operative Complications","time_frame":"Until hospital discharge, limit 60 days","description":"Atrial fibrillation, delirium, renal failure, stroke, myocardial infarction, acute respiratory distress syndrome, infection"},{"outcome_type":"secondary","measure":"Length of Stay","time_frame":"Until hospital discharge, limit 60 days","description":"Duration of intensive care unit stay"},{"outcome_type":"secondary","measure":"Mortality","time_frame":"Until hospital discharge, limit 60 days"},{"outcome_type":"other","measure":"Lactate Levels","time_frame":"Six hours after end of surgery surgery"},{"outcome_type":"other","measure":"Pyruvate Dehydrogenase (PDH) Enzyme Activity","time_frame":"Six hours after end of surgery surgery","description":"PDH activity will be measured in isolated peripheral blood mononuclear cells using a novel immunocapture and microplate-based method"},{"outcome_type":"other","measure":"Time on Mechanical Ventilation","time_frame":"Limit 60 days"},{"outcome_type":"other","measure":"Time on Vasopressors","time_frame":"Limit 60 days"},{"outcome_type":"other","measure":"Global Oxygen Consumption (VO2)","time_frame":"From arrival to ICU to extubation, limit 6 hours","description":"VO2 will be measured with a Compact Anesthesia monitor"},{"outcome_type":"other","measure":"Cellular Oxygen Consumption","time_frame":"Post-surgery within 1 hour of arrival to the ICU","description":"Cellular (peripheral blood mononuclear cells) oxygen consumption measured with the XFe24 Extracellular Flux Analyzers"}]}
{"nct_id":"NCT02404467","start_date":"2015-01-31","enrollment":502,"brief_title":"Feasibility And Safety of Early Discharge After Transfemoral Transcatheter Aortic Valve Implantation","official_title":"Feasibility And Safety of Early Discharge After Transfemoral Transcatheter Aortic Valve Implantation The FAST-TAVI Study","primary_completion_date":"2018-11-30","study_type":"Observational [Patient Registry]","rec_status":"Completed","completion_date":"2019-07-31","last_update":"2020-10-23","description":"The hypothesis behind this study is that there is a proportion of patients considered high or intermediate risk for surgery, but relatively low risk for TAVI, which can be discharged early after the procedure (within the first 2-3 days) without additional risks. Therefore, when performed in safety, an early discharge may cut periprocedural TAVI costs significantly.","other_id":"FAST-TAVI","observational_model":"Other","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"A total of 500 consecutive patients with severe aortic stenosis selected for TF TAVI at the\r\n        respective site will be enrolled. Beyond the applicable criteria of the IFU no further in-\r\n        and exclusion criteria are defined.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  None\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  None\r\n\r\n          -  Beyond the applicable criteria of the IFU no further in- and exclusion criteria are\r\n             defined.\r\n      ","sponsor":"Institut fr Pharmakologie und Prventive Medizin","sponsor_type":"Other","conditions":"Aortic Stenosis","interventions":[{"intervention_type":"Device","name":"Device: TF TAVI","description":"Follow-up Observation of patients having received a TF-TAVI"}],"outcomes":[{"outcome_type":"primary","measure":"Feasibility and safety of early discharge after transfemoral (TF) TAVI (cumulative incidence of death, hospitalization, complications)","time_frame":"30 days after intervention","description":"Cumulative incidence of a combination of all cause death, vascular Access related complications permanent Pacemaker Implantation, re-hospitalization due to cardiac reasons, and Major bleeding complications from day 4 to 30 after TAVI."},{"outcome_type":"secondary","measure":"Stratified Analysis of the cumulative incidence of a combination of the Primary outcome measures according to Patient risk factors and discharge date","time_frame":"30 days after intervention","description":"Cumulative incidence of a combination of the primary outcome from day 4 to 30 in the LR / LD, HR / ED and HR / LD strata. Cumulative incidence of a combination of the primary outcome from day 4 to 15 in all strata."},{"outcome_type":"secondary","measure":"Length-of-Stay after TAVI in days","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Relative costs of TAVI including hospitalization in either stratum compared to the LR / ED group","time_frame":"1 year"}]}
{"nct_id":"NCT02339428","start_date":"2015-01-31","phase":"Phase 3","enrollment":90,"brief_title":"Diclophenac Versus Placebo for Pain Control in Diagnostic Colonoscopy","official_title":"Diclophenac Versus Placebo for Pain Control in Diagnostic Colonoscopy: a Randomized Controlled Study","primary_completion_date":"2016-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-10-31","last_update":"2016-10-26","description":"Patients will be randomized to receive diclophenac sodium or placebo two hours before diagnostic colonoscopy. Intensity of pain as measured on a 10-point Likert scale will be the primary outcome. Patients will be followed until hospital discharge, an average of 10 days.","other_id":"UHRijeka-diclo-colono","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  all inpatients that are referred for colonoscopy for any indication during their\r\n             hospital stay.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  refusal to sign informed consent\r\n\r\n          -  age <18 years\r\n\r\n          -  pregnancy\r\n\r\n          -  lactation\r\n\r\n          -  allergy to any nonsteroidal antiinflammatory drug\r\n\r\n          -  patients that have taken any nonsteroidal antiinflammatory drug in the previous seven\r\n             days before\r\n\r\n          -  randomisation (except acetylsalicylic acid in doses up to 300 mg/day)\r\n\r\n          -  patients on antiplatelet or anticoagulation therapy (except acetylsalicylic acid in\r\n             doses up to 300 mg/day)\r\n\r\n          -  history of gastric or duodenal ulcer\r\n\r\n          -  history of GI bleeding or perforation\r\n\r\n          -  history of or active inflammatory bowel disease\r\n\r\n          -  severe liver disease (defined as presence of history of ascites and/or esophageal\r\n             varices)\r\n\r\n          -  severe kidney disease (defined as glomerular filtration rate <30 ml/min)\r\n\r\n          -  history of myocardial infarction or cerebrovascular disease\r\n\r\n          -  history of peripheral arterial disease\r\n\r\n          -  congestive heart failure (NYHA III-IV)\r\n\r\n          -  history of systemic lupus erythematosus\r\n      ","sponsor":"University Hospital Rijeka","sponsor_type":"Other","conditions":"Anemia","interventions":[{"intervention_type":"Drug","name":"Drug: diclophenac sodium","description":"Patients will be given 100mg p.o. diclophenac sodium tablets"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Inactive pill manufactured to mimic diclofenac tablet"}],"outcomes":[{"outcome_type":"primary","measure":"Reduction of total mean pain index (as measured on a 10-point Likert scale)","time_frame":"Patients will be followed until hospital discharge, an average of 10 days."},{"outcome_type":"secondary","measure":"Reduction of pain in the subgroup of patients with high pain index (defined as patients that report 7-10, inclusive, on a 10-point Likert scale)","time_frame":"Patients will be followed until hospital discharge, an average of 10 days."},{"outcome_type":"secondary","measure":"Reduction of pain in the subgroup of patients with moderate pain index (defined as patients that report 3-6, inclusive, on a 10-point Likert scale)","time_frame":"Patients will be followed until hospital discharge, an average of 10 days."},{"outcome_type":"secondary","measure":"Proportion of patients that are willing to repeat the procedure, if necessary","time_frame":"Patients will be followed until hospital discharge, an average of 10 days."},{"outcome_type":"secondary","measure":"Need for sedation or analgesia during colonoscopy","time_frame":"Patients will be followed until hospital discharge, an average of 10 days."},{"outcome_type":"secondary","measure":"Time to discharge","time_frame":"Patients will be followed until hospital discharge, an average of 10 days."},{"outcome_type":"other","measure":"Adverse events","time_frame":"Patients will be followed until hospital discharge, an average of 10 days."}]}
{"nct_id":"NCT02375191","start_date":"2015-01-31","phase":"N/A","enrollment":58,"brief_title":"A Comparative Study of the Effect of Epidural Dexmedetomidine Versus Fentanyl Added to Ropivacaine in Pediatric Orthopedic Surgery","primary_completion_date":"2016-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-06-30","last_update":"2016-08-17","description":"The purpose of this study is to evaluate the effect of epidural dexmedetomidine added to ropivacaine in pediatric orthopedic surgery","other_id":"4-2014-0921","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":3,"maximum_age":12,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  pediatric patients aged from 3 to 12 years undergoing orthopedic mechanical correction\r\n             surgery\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  coagulopathy, refusal (parents), current infection on the lumbar area, spinal tract\r\n             pathology\r\n      ","sponsor":"Yonsei University","sponsor_type":"Other","conditions":"Congenital Skelectal Anomaly","interventions":[{"intervention_type":"Drug","name":"Drug: fentanyl"},{"intervention_type":"Drug","name":"Drug: dexmedetomidine"},{"intervention_type":"Drug","name":"Drug: Ropivacaine"}],"outcomes":[{"outcome_type":"primary","measure":"Postoperative pain score","time_frame":"During 48 hrs after pediatric orthopedic surgery","description":"CHEOPS, FLACC score were measured"}]}
{"nct_id":"NCT04098926","start_date":"2015-01-31","phase":"N/A","enrollment":70,"brief_title":"Highly Accelerated Dose-Integrated Radiotherapy in 5 Fractions in Breast Cancer","official_title":"Evaluation of Dose Integrated Accelerated Irradiation in Older Women ( 70 Year) With Early and Loco-regionally Advanced Stages of Breast Cancer","primary_completion_date":"2018-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-07-13","last_update":"2019-09-23","description":"Adjuvant radiotherapy in breast cancer improves local control, also in the elderly. Hormonal therapy in hormone sensitive tumors improves results but can not substitute radiotherapy. Improved local control leads to less breast cancer related morbidity and mortality, also in an older population (Schonberg, JCO, 2011). Unfortunately, in older patients with lower life expectancy, adjuvant radiotherapy is often omitted. Following reasons are invoked: - frailty of the patient - fear for toxicity - impaired mobility, rendering transportation and positioning more difficult - dependency for transportation to and from the radiotherapy departement - negative cost effectiveness ratio, due to high cost (especially for complex techniques and long schedules) and lower benefit (lower life expectancy) Hypofractionation is feasible without increased toxicity, and combines better local control with patient comfort and lower costs. Further lowering the number of fractions (from 15-21 to 5) will further improve patient comfort, but is challenging when different doses are needed in the same target volume. This problem is addressed using advanced techniques permitting dose-integration. In the elder with cancer, several unrecognized geriatric problems, including depression and cognitive impairment, can be detected by CGA . Some problems do interact with cancer treatment. In this study screening and assessment is provided to support patients and to develop an inventory of radiotherapy obstacles. Our study includes breast cancer patients, 70 years old, referred for adjuvant radiotherapy after surgical treatment. A schedule of 5 fractions is offered, encompassing different targets of treatment.","other_id":"EC/2014/1167","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -   70 years old\r\n\r\n          -  AND breast conserving surgery or mastectomy for breast carcinoma\r\n\r\n          -  AND multidisciplinary decision of adjuvant irradiation\r\n\r\n          -  AND absence of distant metastases\r\n\r\n          -  AND informed consent obtained, signed and dated before specific protocol procedures\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Bilateral breast irradiation\r\n\r\n          -  In case of mastectomy: positive resection margin, needing boost\r\n\r\n          -  Mental condition rendering the patient unable to understand the nature, scope and\r\n             possible consequences of the study\r\n\r\n          -  Patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability\r\n             to return for follow-up visits, and unlikely to complete the study\r\n\r\n          -  History of previous radiation treatment to the same region\r\n      ","sponsor":"University Hospital, Ghent","sponsor_type":"Other","conditions":"Breast Cancer|Radiotherapy","interventions":[{"intervention_type":"Radiation","name":"Radiation: Dose-integrated accelerated EBRT in pN0 breast cancer","description":"WBI: 5 x 5.7Gy Thoracic wall: 5 x 5.7Gy R0 boost: 5 x 6.5Gy R1 boost: 5 x 6.9Gy"},{"intervention_type":"Radiation","name":"Radiation: Dose-integrated accelerated EBRT in pN+ breast cancer","description":"WBI: 5 x 5.7Gy Thoracic wall: 5 x 5.7Gy R0 boost: 5 x 6.5Gy R1 boost: 5 x 6.9Gy Lymph node region: 5 x 5.4Gy"}],"outcomes":[{"outcome_type":"primary","measure":"Breast retraction (LENTSOMA)","time_frame":"6 weeks post-radiotherapy","description":"Breast Cancer Conservative treatment.core (BCCT.core) objective measurement"},{"outcome_type":"secondary","measure":"Acute toxicity: number of patients with clinical relevant dermatitis (CTCAE v. 4.0)","time_frame":"1-8 weeks","description":"Assessment of grade of dermatitis"},{"outcome_type":"secondary","measure":"Acute toxicity: number of patients with moist desquamation (CTCAE v. 4.0 (grade 3)","time_frame":"1-8 weeks"},{"outcome_type":"secondary","measure":"Acute toxicity: number of patients with pain (CTCAE v. 4.0)","time_frame":"1-8 weeks","description":"Grade 1: mild; Grade 2: moderate, limiting activity of daily living (ADL); grade 3: severe, limiting ADL"},{"outcome_type":"secondary","measure":"Acute toxicity: number of patients with pruritus (CTCAE v. 4.0)","time_frame":"1-8 weeks","description":"Grade 1: mild, localized topical intervention; Grade 2: intense, oral intervention, skin changes"},{"outcome_type":"secondary","measure":"Acute toxicity: number of patients with fatigue (MFI-20)","time_frame":"1-8 weeks","description":"Questionnaire (20 questions)"},{"outcome_type":"secondary","measure":"Chronic toxicity: measurement of patient satisfaction with breast esthetic outcome: BREAST-Q questionnaire","time_frame":"Before radiotherapy and after 2 and 5 years","description":"BREAST-Q questionnaire: Patient reported outcome, evaluating satisfaction with esthetic outcome."},{"outcome_type":"secondary","measure":"Chronic toxicity: prevalence of fibrosis","time_frame":"2 and 5 years","description":"LENT Soma: fibrosis (score 0-3)"},{"outcome_type":"secondary","measure":"Chronic toxicity: prevalence of pain","time_frame":"2 and 5 years","description":"LENT Soma: score 0-4"},{"outcome_type":"secondary","measure":"Chronic toxicity: prevalence of telangiectasia","time_frame":"2 and 5 years","description":"LENT Soma: Score 0-3"},{"outcome_type":"secondary","measure":"Chronic toxicity: prevalence of lymphedema","time_frame":"2 and 5 years","description":"LENT Soma: score 0-4"},{"outcome_type":"secondary","measure":"Chronic toxicity: prevalence of fatigue (MFI-20)","time_frame":"2 and 5 years","description":"Questionnaire (20 questions)"},{"outcome_type":"secondary","measure":"Chronic toxicity - prevalence of radiation induced brachial plexopathy (RIBP) (standardized screening questionnaire), confirmed by electromyogram (EMG)","time_frame":"2 and 5 years","description":"If a screening reveals unilateral pain, loss of function or muscular atrophy in the ipsilateral arm, an EMG will be performed to confirm/exclude RIBP"},{"outcome_type":"secondary","measure":"Loco-regional tumor control","time_frame":"2 and 5 years","description":"Ipsilateral or regional breast recurrence"},{"outcome_type":"secondary","measure":"Distant tumor control","time_frame":"2 and 5 years","description":"Distant metastases free survival"},{"outcome_type":"secondary","measure":"Breast cancer specific survival","time_frame":"2 and 5 years","description":"Number of patients alive and without breast cancer recurrence at 2 and 5 years after adjuvant radiotherapy"},{"outcome_type":"secondary","measure":"Overall survival","time_frame":"2 and 5 years","description":"Number of patients alive, 2 and 5 years after adjuvant radiotherapy"}]}
{"nct_id":"NCT02239094","start_date":"2015-01-31","phase":"N/A","enrollment":20,"brief_title":"Biosignatures of Latuda for Bipolar Depression","official_title":"Identification of Biosignatures for Lurasidone (Latuda) Response in Bipolar Depression","primary_completion_date":"2016-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-09-30","last_update":"2017-12-12","description":"The study proposes to conduct a pilot study of biological predictors of lurasidone response in bipolar depression.","other_id":"#6954","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age 18- 60\r\n\r\n          2. Outpatients with a primary Diagnostic and Statistical Manual of the American\r\n             Psychiatric Association, Fourth Edition (DSM-IV) diagnosis of Bipolar Disorder I, II,\r\n             or NOS (Not Otherwise Specified)\r\n\r\n          3. Current episode of Major Depression\r\n\r\n          4. At least moderate severity of depression\r\n\r\n          5. Agrees to, and is eligible for, electroencephalogram (EEG) / psychological testing,\r\n             magnetic resonance imaging (MRI), and blood draws\r\n\r\n          6. Provides informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Current drug or alcohol abuse/dependence, except nicotine (within 6 months for\r\n             dependence; 2 for abuse)\r\n\r\n          2. Taking any of the following exclusionary medications: antipsychotics, anticonvulsants,\r\n             mood stabilizers, stimulants, antidepressant medications, medications with significant\r\n             interactions with lurasidone, except during the washout prior to testing and blood\r\n             collection\r\n\r\n          3. Unstable medical condition, including significant liver disease, hypothyroidism (i.e.,\r\n             condition not adequately stabilized for 3 months), and conditions likely to require\r\n             hospitalization or with a life expectancy of < 6 mos.*\r\n\r\n          4. Patients considered at significant risk for suicide\r\n\r\n          5. Inadequate understanding of English\r\n\r\n          6. Currently pregnant or breast-feeding; fecund women not using adequate contraceptive\r\n             methods; plan to become pregnant within 12 months\r\n\r\n          7. Contraindications to MRI (e.g. ferromagnetic body implants, history of metal working,\r\n             etc.)\r\n\r\n          8. Have epilepsy, neuromuscular disorder, or tardive dyskinesia\r\n\r\n          9. Require immediate hospitalization for psychiatric disorder\r\n\r\n         10. Require medications for a general medical condition that contraindicate any study\r\n             medication**\r\n\r\n         11. Receiving or have received during the index episode vagus nerve stimulation,\r\n             electroconvulsive therapy, transcranial magnetic stimulation, or other somatic\r\n             treatments\r\n\r\n         12. Allergy to, or other medical contraindication to lurasidone treatment\r\n\r\n         13. Currently enrolled in another research study, and participation in that study\r\n             contraindicates participation\r\n\r\n         14. Clinically significant screening laboratory abnormalities (* see below)\r\n\r\n         15. Currently taking an effective mood stabilizer and/or antidepressant regimen\r\n\r\n         16. Inability to undergo a three week medication-free period, including history of\r\n             significant clinical deterioration from past periods off medication or when medication\r\n             dosage was reduced, including mania, severe depression, etc.\r\n\r\n         17. Any reason not listed herein that would make participation in the study hazardous\r\n             *Medical criteria for exclusion:\r\n\r\n               -  Untreated hypertension: > 140/90 Torr on repeated measurement (If hypertension\r\n                  becomes stabilized, subject may enroll in study)\r\n\r\n               -  Hepatitis: any liver function test > 2x the upper limit of normal\r\n\r\n               -  Renal failure: estimated Glomerular Filtration Rate (eGFR, corrected for body\r\n                  surface area) repeatedly < 30 mL/min\r\n\r\n               -  Hypothyroidism: thryrotropin stimulating hormone level > upper limit of normal\r\n                  (unless accompanied by other euthyroid indices and the confirmation by an\r\n                  internist or endocrinologist that this does not represent hypothyroidism)\r\n\r\n               -  Anemia: hemoglobin < 10 grams/deciliter (borderline hemoglobin must be of known\r\n                  origin, stable, and not clinically significant)\r\n      ","sponsor":"New York State Psychiatric Institute","sponsor_type":"Other","conditions":"Bipolar Depression","interventions":[{"intervention_type":"Drug","name":"Drug: Lurasidone (Latuda)","description":"Antipsychotic medication approved for use with Bipolar disorder"}],"outcomes":[{"outcome_type":"primary","measure":"Montgomery-Asberg Rating Scale for Depression (MADRS)","time_frame":"Baseline","description":"The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression.\r\nNine of the items are based upon patient report, and one is on the rater's observation during the rating interview. MADRS items are rated on a 0-6 continuum (0=no abnormality, 6=severe)."},{"outcome_type":"primary","measure":"Montgomery-Asberg Rating Scale for Depression (MADRS) at Week8","time_frame":"Week 8","description":"The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression.\r\nNine of the items are based upon patient report, and one is on the rater's observation during the rating interview. MADRS items are rated on a 0-6 continuum (0=no abnormality, 6=severe)."}]}
{"nct_id":"NCT02350764","start_date":"2015-01-31","phase":"Phase 2","enrollment":29,"brief_title":"Evaluate the Mediators of Sensitivity and Resistance to Nivolumab Plus Ipilimumab in Patients With Advanced NSCLCs","official_title":"An Exploratory Study to Evaluate the Mediators of Sensitivity and Resistance to Nivolumab Plus Ipilimumab in Patients With Advanced NSCLCs","primary_completion_date":"2023-01-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2023-01-31","last_update":"2021-02-08","description":"The purpose of this study is to closely examine tumor and blood samples from patients treated with nivolumab and ipilimumab in order to try to identify why some patients with lung cancers respond and why some patients do not.","other_id":"14-137","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patient must be capable, willing, and able to provide written, informed consent.\r\n\r\n          -   18 years old.\r\n\r\n          -  Advanced stage NSCLC\r\n\r\n          -  Previously treated with no more than two lines of prior systemic therapy for advanced\r\n             stage lung cancer.\r\n\r\n               -  Patients who previously received neoadjuvant, concurrent, or adjuvant\r\n                  chemotherapy for localized NSCLC and then recurred within 6 months of completing\r\n                  chemotherapy may be considered as having received one line of prior therapy\r\n\r\n               -  Maintenance therapy does not count as a separate line of therapy\r\n\r\n          -  Patients must:\r\n\r\n               -  Be scheduled to undergo a standard-of-care resection of tumor tissue as part of\r\n                  treatment plan prior to beginning study therapy. Patients may not have\r\n                  intervening systemic anti-cancer therapy between the time of resection and\r\n                  treatment with nivolumab.\r\n\r\n               -  Have collection of adequate pre-treatment tissue for correlative analysis defined\r\n                  as sufficient material for 1) frozen tissue for DNA/RNA with touch\r\n                  prep/representative slide confirming tumor material present, 2) FFPE material for\r\n                  ICH with touch prep/representative slide confirming tumor material present, and\r\n                  3) single-cell suspensions with >20 million live cells after tissue digestion but\r\n                  before freezing. Adequacy of collected material will be determined within 5\r\n                  business days of each collected case.\r\n\r\n               -  Have residual disease following surgical resection that is measurable by RECIST\r\n                  v1.1\r\n\r\n               -  Previously irradiated sites of tumor may be considered measurable if there is\r\n                  radiographic progression at that site subsequent to the time of completing\r\n                  radiation.\r\n\r\n               -  Have a safely biopsiable tumor lesion\r\n\r\n          -  ECOG performance status of 0-1.\r\n\r\n          -  Adequate hematologic, renal, and/or hepatic function (following criteria must be met\r\n             within 28 days of C1D1:\r\n\r\n               -  WBC  2,000/ul\r\n\r\n               -  ANC  1,500/ul\r\n\r\n               -  Hemoglobin  9.0 g/dl\r\n\r\n               -  Platelet count  100,000/ul\r\n\r\n               -  Total bilirubin  1.5 x ULN (unless evidence of Gilbert's syndrome, in which\r\n                  case, direct bilirubin must be  1.0 x ULN)\r\n\r\n               -  AST and ALT  3 x UNL (unless elevated transaminases are felt to be directly\r\n                  related to metastatic disease involving the liver, in which case AST and ALT must\r\n                  be  5x ULN)\r\n\r\n               -  Serum creatinine  1.5 x ULN or estimated creatinine clearance of  40 mL/min\r\n                  calculated using the formula of Cockcroft and Gault: (140-Age)  Mass (kg)/(72 \r\n                  creatinine mg/dL); multiply by 0.85 if female\r\n\r\n          -  There is no restriction on the number of prior lines of systemic anti-cancer therapy.\r\n             For those who have received prior systemic anti-cancer therapy, there must be at least\r\n             3 weeks since last systemic therapy.\r\n\r\n          -  Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy\r\n             test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 3 days prior to\r\n             the start of study drug.\r\n\r\n          -  Effective contraception:\r\n\r\n               -  Women of childbearing potential must agree to practice 2 effective methods of\r\n                  contraception from the time of signing the informed consent form through 23 weeks\r\n                  (5 half-lifes plus 30 days, the duration of an ovulatory cycle) after the last\r\n                  dose of nivolumab, or agree to completely abstain from heterosexual intercourse.\r\n\r\n               -  Male subjects, even if surgically sterilized (i.e., status post vasectomy) must\r\n                  agree to 1 of the following: practice effective barrier contraception during the\r\n                  entire study treatment period and through 31 weeks (5 half-lives plus 90 days,\r\n                  the duration of sperm turnover) after the last dose of study drug, or completely\r\n                  abstain from heterosexual intercourse.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who are pregnant or lactating.\r\n\r\n          -  Presence of activating EGFR mutations or ALK re-arrangement,unless previously treated\r\n             with standard TKI therapy. All patients with adenocarcinoma histology must be tested\r\n             for EGFR and ALK status.\r\n\r\n          -  History of allergy to study drug components or history of severe hypersensitivity\r\n             reaction of any monoclonal antibody.\r\n\r\n          -  Prior treatment with immune checkpoint inhibitor, including (but not limited to) those\r\n             targeting PD-1, PD-L1, PD-L2, CTLA-4, CD137, GITR, TIM3, LAG3, or OX40\r\n\r\n          -  Any systemic anti-cancer therapy within 3 weeks prior to C1D1 of study therapy\r\n\r\n          -  Exception is made for patients with EGFR or ALK re-arrangements who must have stopped\r\n             TKI therapy at least 7 days prior to C1D1\r\n\r\n          -  Patients who have not previously been treated with platinum-based based doublet\r\n             chemotherapy and who, in the judgment of the investigator, have rapidly progressive\r\n             disease such that serious complications may arise from disease progression within the\r\n             next 12 weeks will be excluded.\r\n\r\n          -  Non-CNS radiotherapy within 1 week prior to C1D1 of study therapy\r\n\r\n          -  Active infection requiring therapy\r\n\r\n          -  Prior systemic immunosuppressive therapy (> 10 mg/day prednisone equivalents) within 1\r\n             week prior to C1D1 of study therapy. Inhaled, ocular, intra-articular, intranasal, and\r\n             topical corticosteroids are permitted in absence of active autoimmune disease.\r\n\r\n               -  Adrenal replacement doses are permitted in the absence of active autoimmune\r\n                  disease.\r\n\r\n          -  Patients with known or suspected history of autoimmune disease. Subjects with type I\r\n             diabetes melitis, hypothyroidism only requiring hormone replacement, resolved\r\n             childhood asthma/atopy, patients with asthma requiring intermittent bronchodilator\r\n             therapy, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring\r\n             systemic treatment, or conditions not expected to recur in the absence of an external\r\n             trigger are permitted to enroll.\r\n\r\n          -  Other active malignancy requiring concurrent intervention.\r\n\r\n          -  Patients with previous malignancies (except non-melanoma skin cancers, and the\r\n             following in situ cancers: bladder, gastric, colon, cervical/dysplasia, melanoma, or\r\n             breast) are excluded unless definitive therapy has been completed at least 1 year\r\n             prior to study entry and the patient is now without evidence of disease from that\r\n             malignance and no additional therapy is required or anticipated to be required during\r\n             the study period.\r\n\r\n          -  Known untreated brain or leptomeningeal metastasis.\r\n\r\n             o Patients with brain metastases are eligible if metastases have been adequately\r\n             treated and neurologically returned to baseline (except for residual signs or symptoms\r\n             related to the CNS treatment) for at least two weeks prior to C1D1. In addition, must\r\n             also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10\r\n             mg/day prednisone equivalents) for at least 2 weeks prior to study drug\r\n             administration.\r\n\r\n          -  Patients with interstitial lung disease that is symptomatic or may interfere with the\r\n             detection or management of suspected drug-related pulmonary toxicity.\r\n\r\n          -  Any positive test for HIV\r\n\r\n          -  Any positive test for HCV RNA or HBsAg.\r\n      ","sponsor":"Memorial Sloan Kettering Cancer Center","sponsor_type":"Other","conditions":"Advanced Stage Non-small Cell Lung Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: nivolumab"},{"intervention_type":"Drug","name":"Drug: pilimumab"}],"outcomes":[{"outcome_type":"primary","measure":"Best overall response rate (confirmed partial + complete response) will be assessed as part of this study. Tumor response will be assessed using RECIST 1.1)","time_frame":"every 6 weeks (+/- 1 week) until week 48","description":"confirmed partial + complete response will be assessed as part of this study. Tumor response will be assessed using RECIST 1.1. All responses must be confirmed on subsequent scan to be considered a true response. Tumor assessments will be performed after.6 weeks (+/- 1 week) and subsequently every six week (+/- 1 week) thereafter while on study until week 48. After week 48, tumor assessments will be conducted every 12 weeks (+/- week). Additional tumor assessments may be performed at the discretion of the treating physician."}]}
{"nct_id":"NCT02264210","start_date":"2015-01-31","phase":"Phase 2","enrollment":128,"brief_title":"Icotinib for Completed Resected IB NSCLC With EGFR Mutation","official_title":"A Randomized, Phase II Trial of Icotinib Versus Observation as Adjuvant Treatment in Stage IB Non-Small Cell Lung Cancer Harboring Activating Epidermal Growth Factor Receptor Mutation","primary_completion_date":"2025-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2025-12-31","last_update":"2021-08-03","description":"This phase II trial studies how well icotinib works in treating patients with completely resected stage IB NSCLC harboring EGFR mutation.","other_id":"GASTO1003","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Written informed consent provided.\r\n\r\n          -  Males or females, Aged 18-75 years.\r\n\r\n          -  Able to comply with the required protocol and follow-up procedures, and able to\r\n             receive oral medications.\r\n\r\n          -  Had completely resected pathological confirmed stage IIA-IIIA NSCLC.\r\n\r\n          -  EGFR activating mutation in exon 19 or 21.\r\n\r\n          -  Patient who can start the investigational therapy within 3-6 weeks after the complete\r\n             resection.\r\n\r\n          -  ECOG performance status of 0-1.\r\n\r\n          -  Had a life expectancy of 12 weeks or more.\r\n\r\n          -  Adequate hematological function, adequate liver function and renal function.\r\n\r\n          -  Female patients, except those who are postmenopausal or surgically sterilized, must\r\n             have a negative pre-study serum or urine pregnancy test.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Had had previous chemotherapy, radiotherapy, or agents directed at the HER axis (e.g.\r\n             erlotinib, gefitinib, cetuximab, trastuzumab).\r\n\r\n          -  Inability to comply with protocol or study procedures.\r\n\r\n          -  Had a history another malignancy in the last 5 years with the exception of cured basal\r\n             cell carcinoma of the skin, cured in situ carcinoma of the uterine cervix and cured\r\n             epithelial carcinoma of the bladder.\r\n\r\n          -  Any evidence confirmed tumor recurrence before investigational therapy.\r\n\r\n          -  Known severe hypersensitivity to icotinib or any of the excipients of this product.\r\n\r\n          -  Evidence of clinically active interstitial lung disease.\r\n\r\n          -  Eye inflammation not fully controlled or conditions predisposing the subject to this.\r\n\r\n          -  Any unstable systemic disease (including active infection, uncontrolled hypertension,\r\n             unstable angina, congestive heart failure, myocardial infarction within the previous 6\r\n             months, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic\r\n             disease).\r\n\r\n          -  Known human immunodeficiency virus (HIV) infection.\r\n\r\n          -  Pregnancy or breast-feeding women.\r\n\r\n          -  Ingredients mixed with small cell lung cancer patients.\r\n\r\n          -  History of neurologic or psychiatric disorders.\r\n      ","sponsor":"Sun Yat-sen University","sponsor_type":"Other","conditions":"Lung Neoplasms|Squamous Cell Lung Cancer|Adenocarcinoma of the Lung|Adenosquamous Cell Lung Cancer|Large Cell Lung Cancer|Bronchial Neoplasms|Stage IB Non-small Cell Lung Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Icotinib","description":"Icotinib 125 mg three times daily (375 mg per day) by mouth for 12 months."}],"outcomes":[{"outcome_type":"primary","measure":"Disease-free survival","time_frame":"From randomization to the time of disease recurrence or death as a result of any cause, assessed up to 5 years","description":"DFS will be estimated by the method of Kaplan-Meier"},{"outcome_type":"secondary","measure":"Overall survival","time_frame":"From randomization to the time of death as a result of any cause, assessed up to 5 years","description":"OS will be estimated by the method of Kaplan-Meier"},{"outcome_type":"secondary","measure":"Number of Participants with Adverse Events","time_frame":"Up to 5 years","description":"The NCI Common Terminology Criteria for Adverse Events version 3.0 will be used"}]}
{"nct_id":"NCT02223377","start_date":"2015-01-31","phase":"N/A","enrollment":402,"brief_title":"Satisfactory Analgesia Minimal Emesis in Day Surgeries","official_title":"Most Effective Opioid Analgesia in Ambulatory Surgeries: a Randomized Control, Investigator Blinded, Parallel Group With Superiority Design Study of Morphine Versus Hydromorphone","primary_completion_date":"2019-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-03-31","last_update":"2020-01-13","description":"Currently nearly 70% or more surgeries are being done as ambulatory (day care) procedures as they offer significant benefit to the patients as well as to the hospitals. Inadequate pain relief (30%-40%) and nausea-vomiting form the leading factors affecting the quality of care and hence its efficiency. Opioids form the primary modality to treat moderate to severe pain, but can also cause significant nausea-vomiting and other side effects. Although hydromorphone is five times more potent than morphine, in equianalgesic doses they both could provide similar pain relief. They both exert no ceiling effect for their analgesia, and hence incomplete or inadequate analgesia is related to the appearance of side effects. In this study the investigators shall assess the proportion of patients who satisfy the outcome of 'satisfactory analgesia with minimal nausea-vomiting' in ambulatory surgeries, assessed at 2 hours after surgery. Patients would be randomized to receive either morphine or hydromorphone in the surgical recovery area. All personnel involved with the study would be blinded. The investigators will also look to assess the time to discharge and other side effects. This will help to choose the better drug, thereby improving pain relief and side effects, and also the efficiency of health care delivery.","other_id":"14-482","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  ambulatory surgeries producing at least moderate pain-such as cholecystectomy,\r\n             appendicectomy, ovarian cystectomy, inguinal hernia repair, abdominal wall hernias\r\n\r\n          -  ability to communicate in English.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  allergy to M or HM\r\n\r\n          -  patient on regular chronic opioid medication\r\n\r\n          -  patient uncontrolled systemic disease\r\n\r\n          -  severe obesity with a BMI >35\r\n\r\n          -  significant psychological impairment\r\n\r\n          -  history of drug addiction or dependence\r\n\r\n          -  any planned regional or nerve block other than local anesthesia infiltration patients\r\n             with confirmed sleep apnea\r\n\r\n          -  emergency surgeries and urological surgeries\r\n      ","sponsor":"McMaster University","sponsor_type":"Other","conditions":"Pain|Post Operative Nausea and Vomiting","interventions":[{"intervention_type":"Drug","name":"Drug: Morphine","description":"Participant to be asked for their pain score, and if it is more than 4 out of 10 (NAS): to receive the 1st dose within 5 minutes after coming to PACU: 0.04mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml); with a maximum of 3 mg of morphine equivalents. Repeat doses: 0.02 mg/kg morphine units every 5-10 minutes to titrate for analgesia and side effects (rounding off to the nearest 1 ml or 0.5 ml)"},{"intervention_type":"Drug","name":"Drug: Hydromorphone","description":"Participant to be asked for their pain score, and if it is more than 4 out of 10 (NAS): to receive the 1st dose within 5 minutes after coming to PACU: 0.04mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml); with a maximum of 3 mg of morphine equivalents. Repeat doses: 0.02 mg/kg morphine units every 5-10 minutes to titrate for analgesia and side effects (rounding off to the nearest 1 ml or 0.5 ml)"}],"outcomes":[{"outcome_type":"primary","measure":"Our combined primary outcome will be proportion of patients with Same Analgesia Minimal Emesis, as compared between the 2 groups.","time_frame":"At 2hrs or at the time of discharge from PACU","description":"Our combined primary outcome will be proportion of patients with SAME, as compared between the 2 groups. Analgesia will be based on Numerical Analogue Scale for Pain 0-10 (appendix 3), and Post-operative nausea and vomiting will be based on Verbal Descriptive Scale 0-5 (appendix 3). These observations will be made at the end of 2 hrs or before (corresponding to the time of discharge from PACU), by the PACU nurse."},{"outcome_type":"secondary","measure":"Severe itching","time_frame":"At 2hrs or at the time of discharge from PACU","description":"Visual Analog Scale 0-10"},{"outcome_type":"secondary","measure":"Severe sedation","time_frame":"At 2hrs or at the time of discharge from PACU","description":"Ramsay Sedation Scale 0-6"},{"outcome_type":"secondary","measure":"Severe Respiratory Depression","time_frame":"At 2hrs or at the time of discharge from PACU","description":"Presence of Respiratory Rate below 10 and/or Presence of Oxygen Saturation <90"},{"outcome_type":"secondary","measure":"Use of Ketorolac","time_frame":"At 2hrs or at the time of discharge from PACU","description":"Use of rescue drug for pain"},{"outcome_type":"secondary","measure":"Mean dose of analgesic used","time_frame":"5 hours post-admit to hospital","description":"For a day surgery case, from the time of hospital admittance to discharge from hospital is an average 5 hours."},{"outcome_type":"secondary","measure":"Patient Satisfaction Score","time_frame":"At 5 hours post-admit to hospital","description":"For a day surgery case, from the time of hospital admittance to discharge from hospital is an average 5 hours."},{"outcome_type":"secondary","measure":"Time to discharge from PACU","time_frame":"At 2hrs or at the time of discharge from PACU","description":"For a day surgery case, from the time out of operating room to discharge from PACU is an average 2 hours."},{"outcome_type":"secondary","measure":"Time to discharge from hospital","time_frame":"At 5 hours post-admit to hospital","description":"For a day surgery case, from the time of hospital admittance to discharge from hospital is an average 5 hours."}]}
{"nct_id":"NCT02211443","start_date":"2015-01-31","phase":"Phase 1","enrollment":21,"brief_title":"Safety, Tolerability and Pharmacokinetics of Recombinant Anti-epidermal Growth Factor Receptor(EGFR) Monoclonal Antibody in Patients With Metastatic Colorectal Cancer","official_title":"A Phase I Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of SCT200, a Recombinant Full Human Anti-epidermal Growth Factor Receptor(EGFR) Monoclonal Antibodyin Patients With Metastatic Colorectal Cancer Following Fluoropyrimidine, Irinotecan and Oxaliplatine Chemotherapy Regiment","primary_completion_date":"2015-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2015-12-31","last_update":"2015-04-09","description":"The purpose of this study is to determine whether SCT200 is safe and tolerant in the treatment of metastatic colorectal cancer","other_id":"SCT200mCRCI","allocation":"Non-Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  aged from 18 to 70 years;\r\n\r\n          -  having histologically confirmed metastatic colorectal cancer;\r\n\r\n          -  having experienced previous treatment failures including fluoropyrimidine, irinotecan\r\n             and oxaliplatine chemotherapy regiment;\r\n\r\n          -  having determined wild-type KRAS tumor;\r\n\r\n          -  having to have measurable or nonmeasurable disease per Response Evaluation Criteria In\r\n             Solid Tumors (RECIST) version 1.1;\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; and expected\r\n             survival of at least 3 months;\r\n\r\n          -  adequate hematological, renal and liver functions:\r\n\r\n               1. Hematological function: white blood cell count of >4.0109/L; absolute neutrophil\r\n                  count of >1.5109/ L; platelet count of >100109/L; hemoglobin level of >90.0\r\n                  g/L;\r\n\r\n               2. Renal function: serum creatinine level of<1.5upper limit of normal (ULN);\r\n\r\n               3. Liver function: total bilirubin level of<1.5ULN; aspartate amino transferase\r\n                  (AST) and alanine amino transferase (ALT) levels of <1.5ULN; or <5  ULN for\r\n                  patients with liver metastases;\r\n\r\n          -  no other malignancies only if they had following malignancies , which were not\r\n             required to treat or who had curative resection: cervical carcinoma in situ, the skin\r\n             basal carcinoma or squamous cell carcinoma, bladder epithelial tumors, or only they\r\n             had some malignancies requirement only surgical therapy and disease free survival5\r\n             years;\r\n\r\n          -  no serious nonmalignant diseases including hypertension, diabetes mellitus, coronary\r\n             artery disease, and mental disorder.\r\n\r\n          -  not pregnant; or not lactating; or accepted birth control methods during the study;\r\n\r\n          -  signed an informed consent form which was approved by the institutional review board\r\n             of the respective medical center .\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  had received EGFR target treatment including EGFR tyrosine kinase inhibitors(TKI), or\r\n             anti- EGFR monoclonal antibody;\r\n\r\n          -  having to be at least 4 weeks beyond prior anticancer therapy (including\r\n             corticosteroid , or nitrosourea or mitomycin within 6 weeks of study entry) or\r\n             participating in other clinical trial, or have not recovered from significant\r\n             toxicities of prior therapy;\r\n\r\n          -  chronic use of medication that could interfere with the assessment of drug-related\r\n             toxicities or immunologic activity (high dose prednisone or high dose non-steroid\r\n             anti-inflammatory medication);\r\n\r\n          -  had recent major surgery (within 28 days);\r\n\r\n          -  with symptomatically brain metastases (with the exception of clinically brain\r\n             metastases stable and of no requirement further treatment);\r\n\r\n          -  with active infection requirement systemic antibiotics treatment; or serious\r\n             cardiovascular disease;or with evidence of active hepatitis B or C infection; or with\r\n             human immunodeficiency virus infection;\r\n\r\n          -  had acute pulmonary disorder; or interstitial pneumonia; or symptomatically chronic\r\n             obstructive pulmonary disease (COPD) or with risk factors to COPD;\r\n\r\n          -  with eye inflammation or infection, or any risk factors who could lead to eye disease;\r\n\r\n          -  with a history of allergic reaction or protein product allergy including antibodies\r\n             product;\r\n\r\n          -  pregnant, or lactating, or not accepted birth control methods including male patients.\r\n\r\n          -  had a history of alcohol or drugs addiction, or with any risk which may affect the\r\n             patient's health evaluation or mantle state\r\n      ","sponsor":"Sinocelltech Ltd.","sponsor_type":"Industry","conditions":"Metastatic Colorectal Cancer","interventions":[{"intervention_type":"Biological","name":"Biological: Recombinant full human Anti-EGFR Monoclonal Antibody"}],"outcomes":[{"outcome_type":"primary","measure":"Number of participants with SCT200-related adverse events","time_frame":"up to 105 days"},{"outcome_type":"secondary","measure":"Area Under the plasma concentration versus time curve (AUC) of SCT200","time_frame":"prior to the initial dose and 0,0.5,1,2,4,8,24,48 hours,4,7,14,21days post- first dose"},{"outcome_type":"other","measure":"Time to Disease Progression (TTP) of SCT200","time_frame":"up to 105 days"}]}
{"nct_id":"NCT02364960","start_date":"2015-01-31","enrollment":16,"brief_title":"Targeted Intraoperative Therapy Registry at Bethesda North Hospital (TARGIT)","official_title":"Implementation of the Target Intraoperative Therapy Registry at Bethesda North TriHealth Hospital (TARGIT)","primary_completion_date":"2015-12-31","study_type":"Observational [Patient Registry]","rec_status":"Terminated","completion_date":"2016-01-31","last_update":"2018-08-22","description":"The purpose of this study is to create a registry to evaluate the use of intra-operative radiation therapy (IORT) and to study the efficacy and toxicity of breast radiotherapy given intra-operatively as a single fraction after breast conserving surgery,","other_id":"14-047","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"Female","minimum_age":45,"population":"Women, aged 45 and greater who have been diagnosed with early stage invasive breast cancer\r\n        that is suitable for breast conserving surgery.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Female\r\n\r\n          -  Age 45 or greater\r\n\r\n          -  Diagnosed with operable invasive breast cancer, T1 and T2 (< 3.5 cm), N0, M0,\r\n             confirmed by cytological or histological examination\r\n\r\n          -  Suited for breast conserving surgery\r\n\r\n          -  Have had an ipsilateral (same side as current cancer) diagnostic mammogram within 12\r\n             months of enrollment\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  age 44 or less\r\n\r\n          -  Axillary lymph node positive breast cancer\r\n\r\n          -  Invasive lobular cancer\r\n\r\n          -  Tumor size > 3.5 cm\r\n\r\n          -  Extensive Intraductal Component (EIC= > 25% of the lumpectomy specimen involved with\r\n             ductal carcinoma in situ, DCIS) as assessed on surgical pathologic lumpectomy specimen\r\n\r\n          -  Multicentric cancer in the same breast not amenable to excision with a single\r\n             lumpectomy\r\n\r\n          -  Inability to assess pathologic margin status\r\n\r\n          -  Synchronous bilateral breast cancer at the time of diagnosis.\r\n\r\n          -  Ipsilateral breast had a previous cancer and/or prior in-field radiation.\r\n\r\n          -  Patients known to have BRCA1/2 gene mutations\r\n\r\n          -  Neoadjuvant treatment (hormones or chemotherapy)\r\n      ","sponsor":"TriHealth Inc.","sponsor_type":"Other","conditions":"Early Stage Breast Cancer|Neoplasm of the Breast|Breast Tumor","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"In-breast local failure and patterns of in-breast failure","time_frame":"6 months after IORT through year 10","description":"In-breast local failure is defined as recurrence of cancer in the ipsilateral (same side) breast. Following IORT, patients will be monitored every 6 months for 3 years, and then annually in years 4 and 5 to determine if cancer has returned. In years 6 through 10 medical records will be reviewed to obtain information on participants' breast cancer status."}]}
{"nct_id":"NCT02415465","start_date":"2015-01-31","phase":"N/A","enrollment":157,"brief_title":"Continuous Adductor Canal Block (CACB) vs. Combined Spinal Epidural (CSE) in Total Knee Arthroplasty","official_title":"Continuous Adductor Canal Block (CACB) vs. Combined Spinal Epidural (CSE) in Total Knee Arthroplasty","primary_completion_date":"2016-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-03-31","last_update":"2016-04-15","description":"Purpose: Compare continuous adductor canal block (CACB) to Combined Spinal Epidural (CSE) for total knee arthroplasty in terms of mobility, post-operative pain, and analgesic use. Hypothesis: CACB will provide better mobility than CSE post operatively.","other_id":"14090501","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Any patient scheduled for a primary unilateral TKA.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Partial knee replacement,\r\n\r\n          -  chronic opioid use,\r\n\r\n          -  history of alcohol or drug abuse,\r\n\r\n          -  preexisting neuropathy in operative limb,\r\n\r\n          -  allergy to local anesthetics,\r\n\r\n          -  ASA Class >3,\r\n\r\n          -  patients who decline to participate,\r\n\r\n          -  BMI >40,\r\n\r\n          -  sleep apnea.\r\n      ","sponsor":"Rush University Medical Center","sponsor_type":"Other","conditions":"Arthroplasty","interventions":[{"intervention_type":"Procedure","name":"Procedure: Continuous Adductor Canal Block","description":"Continuous Adductor Canal Block (0.2% ropivacaine running at 6-8mL/hr)"},{"intervention_type":"Procedure","name":"Procedure: General","description":"General Intraoperative Anesthesia"},{"intervention_type":"Procedure","name":"Procedure: Epidural","description":"Epidural (0.1% bupivacaine with fentanyl 5 mcg/mL running at 6mL/hr with 1mL q15 bolus)"},{"intervention_type":"Procedure","name":"Procedure: Spinal","description":"Spinal Intraoperative Anesthesia"}],"outcomes":[{"outcome_type":"primary","measure":"Ambulation Distance in feet","time_frame":"daily after surgery until discharge from hospital, expected average up to 5 days","description":"Patient ambulation distance will be measured daily after surgery until discharge from hospital"},{"outcome_type":"secondary","measure":"Straight Leg Raise","time_frame":"daily after surgery until discharge from hospital, expected average up to 5 days","description":"Patient's ability to perform straight leg raise daily after surgery until discharge from hospital."},{"outcome_type":"secondary","measure":"Quadriceps strength","time_frame":"daily after surgery until discharge from hospital, expected average up to 5 days","description":"Quadriceps strength evaluated using a standard non-invasive handheld dynamometer once pre-operatively and daily after surgery until discharged from hospital."},{"outcome_type":"secondary","measure":"Pain as measured by numeric pain score","time_frame":"daily after surgery until discharge from hospital, expected average up to 5 days","description":"Post-operative numeric pain scores during rest and with activity during daily inpatient physical therapy sessions until discharge from hospital"},{"outcome_type":"secondary","measure":"Post-operative inpatient opioid consumption (morphine equivalents)","time_frame":"daily after surgery until discharge from hospital, expected average up to 5 days","description":"Post-operative inpatient opioid consumption (morphine equivalents) measured daily after surgery until discharge from hospital."},{"outcome_type":"secondary","measure":"Surgery Complications and Adverse Events during inpatient stay","time_frame":"daily after surgery until discahrge from hospital, expected average up to 5 days","description":"Surgery Complications and Adverse Events during inpatient stay\r\nRespiratory depression\r\nSedation\r\nNausea\r\nEmesis\r\nMotor Blockade\r\nPruritus\r\nUrinary Retention\r\nHypotension\r\nNumbness\r\nFalls\r\nDVT or PE\r\nCatheter Site Infection\r\nBlock Success"}]}
{"nct_id":"NCT02262416","start_date":"2015-01-31","phase":"Phase 3","enrollment":200,"brief_title":"GnRH Agonist and Progesterone Versus Progesterone Only for Luteal Phase Support in Antagonist Cycles","official_title":"A Prospective Randomised Controlled Trial of GnRH Agonist and Progesterone Versus Progesterone Only for Luteal Phase Support in Antagonist Cycles","primary_completion_date":"2016-01-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2016-01-31","last_update":"2014-10-13","description":"In-Vitro Fertilisation (IVF) is the term commonly applied to a form of treatment for infertility that involves controlled ovarian hyperstimulation, egg maturation, egg collection, fertilisation, embryo culture and finally embryo transfer. The period after egg collection is called luteal phase. In Australia, vaginal progesterone is routinely used to support the lining of the uterus so that it is susceptible to implantation of the embryos. More recently, there has been some suggestion that additional supplementation of luteal phase with GnRH agonist increases clinical pregnancy and live birth rate. These studies are however heterogeneous and results were inconsistent. This study is a prospective randomised controlled trial of additional GnRH agonist in luteal phase of antagonist cycle. The primary hypothesis is that GnRH agonist increases the number of live birth . The secondary hypothesis is that this increases the clinical pregnancy rate, on-going pregnancy rate, without affecting the miscarriage rate, ovarian hyperstimulation rate and multiple pregnancy rate.","other_id":"01102014","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":42,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Single embryo transfer\r\n\r\n          2. Antagonist cycle with HCG trigger\r\n\r\n          3. Use of progesterone as luteal phase support (crinone or progesterone pessary )\r\n\r\n          4. Women undergoing their first IVF cycle with TFC\r\n\r\n          5. Age 18-42 inclusive\r\n\r\n        Exclusion Criteria:\r\n\r\n        No or frozen embryo transfer planned b. Use of other luteal support c. Known\r\n        contraindication to the use of GnRH analogue\r\n      ","sponsor":"Queensland Fertility Group","sponsor_type":"Other","conditions":"Infertility","interventions":[{"intervention_type":"Drug","name":"Drug: leuprolide","description":"normal saline"}],"outcomes":[{"outcome_type":"primary","measure":"live birth","time_frame":"1 year","description":"live birth"},{"outcome_type":"primary","measure":"on-going pregnancy","time_frame":"3 months","description":"+ve fetal heart rate at nuchal scan"},{"outcome_type":"secondary","measure":"pregnancy","time_frame":"2 weeks","description":"positive serum pregnancy test"},{"outcome_type":"secondary","measure":"Ovarian hyperstimulation syndrome","time_frame":"3 months","description":"hospitalisation due to the condition"}]}
{"nct_id":"NCT02298803","start_date":"2015-01-31","phase":"N/A","enrollment":30,"brief_title":"QT Interval Abnormalities in Sulfonylurea Treated Type 2 Diabetes: Relationship to Treatment Induced Hypoglycaemia","official_title":"QT Interval Abnormalities in Sulfonylurea Treated Type 2 Diabetes: Relationship to Treatment Induced Hypoglycaemia and Glycaemic Variability Determined by Simultaneous Ambulatory Monitoring","primary_completion_date":"2016-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-01-31","last_update":"2018-02-28","description":"Hypoglycaemia is the most common acute complication of diabetes and can limit therapeutic efforts to improve glycaemic control. It is a potential side effect of drugs used to treat diabetes, particularly with the use of sulfonylurea (SU) treatment. It has been demonstrated that hypoglycaemia causes the prolongation of corrected QT (QTc) interval, which is associated with ventricular arrhythmias and sudden death. Hypoglycaemia in T2DM has recently come into focus with the results of the ACCORD, ADVANCE and VADT trials. In this study, the investigators aim to examine the association of hypoglycaemia and glucose fluctuations on QT-interval and QT variability in patients with type 2 diabetes treated with SU. Patients will be studied using simultaneous Continuous Glucose Monitoring (CGM) and ambulatory ECG monitoring (Holter). Study participants will be recruited from the Diabetes Centre, RPAH or from specialist consulting rooms. They will be required to attend the Diabetes Centre on two occasions. At the first visit, blood will be collected and CGM and Holter monitoring commenced. At Visit 2, i.e. two days later, the patient will return to the Diabetes Centre to have the equipment removed. The data obtained from the CGM and Holter monitor will then be downloaded for review and analysis.","other_id":"X14 0314","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Type 2 diabetes\r\n\r\n          -  A history of symptomatic or documented hypoglycaemia\r\n\r\n          -  Currently treated with a sulphonylurea  any anti-diabetic agent/s other than insulin\r\n\r\n          -  Currently performing home blood glucose monitoring and willing to do seven tests a day\r\n             during the study period\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Type 1 diabetes\r\n\r\n          -  Current treatment with insulin\r\n\r\n          -  LBBB and conduction anomalies that preclude QT analysis\r\n\r\n          -  Drugs that prolong QT interval\r\n\r\n          -  Family history of Long QT syndrome\r\n      ","sponsor":"Royal Prince Alfred Hospital, Sydney, Australia","sponsor_type":"Other","conditions":"Diabetes Related Complications","interventions":[{"intervention_type":"Device","name":"Device: Holter and Glucose monitoring","description":"(i) Continuous Glucose Monitoring A sterile disposable glucose-sensing sensor will be inserted into the subcutaneous tissues in either the abdomen or the upper outer quadrant of the patient's buttock. This sensor automatically measures the change in glucose in interstitial fluid every 5 minutes. The monitor will be worn for two days.\r\n(ii)Holter Monitoring The Holter monitor to capture cardiac conduction, specifically QT interval, will be worn for the same period as the continuous glucoe monitor with study participants encouraged to perform regular daily activities."}],"outcomes":[{"outcome_type":"primary","measure":"Change in the Corrected QT-interval During Nocturnal Hypoglycemia","time_frame":"Nocturnal time period (2300-0700) during the 48 hours of Holter monitoring","description":"The nocturnal time period for the study spanned from 11 pm in the evening until 7 am the following morning on two consecutive days. The change in the corrected QT interval during nocturnal hypoglycemia was determined by calculating the difference between the average QTc interval length during periods of hypoglycemia (blood glucose level <3.5 mmol/L) and the average QTc interval length during periods of normoglycemia (blood glucose level >3.5 mmol/L) for the nocturnal time period. The average QTc interval was calculated using an individually optimised correction formula. If the result of average QTc (hypoglycemia) - average QTc (normoglycemia) was positive, the participant experienced QTc prolongation during hypoglycemia. If the result of average QTc (hypoglycemia) - average QTc (normoglycemia) was negative, the participant experienced QTc shortening during hypoglycemia."},{"outcome_type":"primary","measure":"Change in Corrected QT Interval During Day Time Hypoglycaemia","time_frame":"Day time period (0700-2300) during the 48 hours of Holter monitoring","description":"The day time period for the study spanned from 7 am in the morning until 11 pm in the evening on two consecutive days. The change in the corrected QT interval during day time hypoglycemia was determined by calculating the difference between the average QTc interval length during periods of hypoglycemia (blood glucose level <3.5 mmol/L) and the average QTc interval length during periods of normoglycemia (blood glucose level >3.5 mmol/L) for the day time period. The average QTc interval was calculated using an individually optimised correction formula. If the result of average QTc (hypoglycemia) - average QTc (normoglycemia) was positive, the participant experienced QTc prolongation during hypoglycemia. If the result of average QTc (hypoglycemia) - average QTc (normoglycemia) was negative, the participant experienced QTc shortening during hypoglycemia."},{"outcome_type":"secondary","measure":"Pearson's Correlation Coefficient of Delta QTc and a Measure of Glucose Variability, MAGE (Mean Amplitude of Glycemic Excursion).","time_frame":"Nocturnal time period (2300-0700) during the 48 hours of Holter monitoring","description":"MAGE, a commonly used index of glucose variability, was calculated using data obtained during continuous glucose monitoring. Analysis of correlation between MAGE and delta QTc was undertaken. Please note delta QTc represents the difference between average QTc length during hypoglycemia and average QTc length during normoglycemia."},{"outcome_type":"secondary","measure":"Mean Amplitude of Glycemic Excursion (MAGE)","time_frame":"48 hours of continuous glucose monitoring","description":"The MAGE results (in mmol/L) for the eight participants who experienced nocturnal hypoglycemia are included in the table below."},{"outcome_type":"secondary","measure":"deltaQTc","time_frame":"Nocturnal time period (2300-0700) during the 48 hours of Holter monitoring","description":"deltaQTc is the difference in QTc observed during periods of hypoglycemia and periods of normoglycemia (for those participants who experienced nocturnal hypoglycemia)"}]}
{"nct_id":"NCT03120858","start_date":"2015-01-31","enrollment":185,"brief_title":"Turkish Version of the Kinesthetic and Visual Imagery Questionnaire","official_title":"Reliability and Validity of the Turkish Version of the Kinesthetic and Visual Imagery Questionnaire","primary_completion_date":"2016-05-31","study_type":"Observational","rec_status":"Completed","completion_date":"2017-01-31","last_update":"2017-08-14","description":"Imagery is determined with two strategies to mentally simulate the movements: visual and kinesthetic imagery. Visual motor imagery (VMI) is associated with spatial coordinates of a movement in the environment and through this speciality VMI applies mainly to the imagery of moving objects or to movement of another person in the imagined environment, although imagine of own movement is also possible. Kinesthetic motor imagery depends on dynamic relationship among the individual, the movement and the environment and it should be determined by the nature of the task, the environment and individual characteristics and also requires \"feel\" the movement. The aim of this study is to translate this questionnaire into Turkish and the translation in terms of its internal consistency, test-retest reliability.","other_id":"GO 14/568","observational_model":"Other","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":65,"population":"Healthy volunteers","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  ages between 18-65 years, healthy volunteers, with no limitation in mobility or\r\n             movement disorder, with no chronic pain\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  refuse to attend to the study, neurological conditions\r\n      ","sponsor":"Hacettepe University","sponsor_type":"Other","conditions":"Image, Body|Healthy|Pain","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Determine what the imagery levels are","description":"Determine the motor imagery: kinesthetic and visual imagery"}],"outcomes":[{"outcome_type":"primary","measure":"Cronbach's Alpha coefficient","time_frame":"2 years","description":"Cronbach's Alpha coefficient was used to determine internal consistency of the questionnaire and its subscales. Cronbach's Alpha Coefficient greater than 0.8 is generally considered acceptable."}]}
{"nct_id":"NCT02640794","start_date":"2015-01-31","phase":"Phase 4","enrollment":222,"brief_title":"Aspirin Versus Aspirin+Clopidogrel as Antithrombotic Treatment Following TAVI","official_title":"Aspirin Versus Aspirin + ClopidogRel as Antithrombotic Treatment Following Transcatheter Aortic Valve Implantation With the Edwards Valve. A Randomized Study (the ARTE Trial)","primary_completion_date":"2017-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-03-31","last_update":"2018-07-17","description":"The purpose of this study is to compare aspirin/acetylsalicylic acid+ clopidogrel with aspirin/acetylsalicylic acid alone as antithrombotic treatment following TAVI for the prevention of major ischemic events (MI, ischemic stroke) or death without increasing the risk of major bleeding events.","other_id":"ARTE2","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients undergoing a TAVI procedure with the Edwards valve.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Need for chronic anticoagulation treatment\r\n\r\n          -  Major bleeding within the 3 months prior to the TAVI procedure\r\n\r\n          -  Prior intracranial bleeding\r\n\r\n          -  Drug-eluting stent implantation within the year prior to the TAVI procedure\r\n\r\n          -  Allergy to clopidogrel and/or aspirin/acetylsalicylic acid\r\n      ","sponsor":"Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec","sponsor_type":"Other","conditions":"Aortic Valve Disease|Myocardial Infarction|Stroke|Bleeding","interventions":[{"intervention_type":"Drug","name":"Drug: Clopidogrel","description":"Clopidogrel therapy will start within 24 hrs before the TAVI procedure in cases where a transfemoral approach is used and within 24 hrs after the TAVI procedure in cases where a transapical approach is used. The initial dose of clopidogrel will be of 300 mg followed by 75 mg/die. The duration of clopidogrel treatment will be of 3 months."},{"intervention_type":"Drug","name":"Drug: Aspirin","description":"Aspirin/acetylsalicylic acid (80-325 mg/d). Aspirin/acetylsalicylic acid therapy will start at least 24 hrs before the TAVI procedure and continued for at least 6 months."}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of death, MI, ischemic stroke/Transient ischemic attack (TIA) or life threatening/major bleeding at 3-month follow-up.","time_frame":"3-month follow-up","description":"The composite endpoint of incidence of death, MI, ischemic stroke/Transient ischemic attack (TIA) or life life threatening/major bleeding at 3-month follow-up will be analyzed"},{"outcome_type":"secondary","measure":"Incidence of death, MI, ischemic stroke/TIA or life threatening/major bleeding at 30 days","time_frame":"30 days","description":"The composite endpoint of Incidence of death, MI, ischemic stroke/TIA or life threatening/major bleeding at 30 days will be analyzed"},{"outcome_type":"secondary","measure":"Incidence of death, MI, ischemic stroke/TIA or life threatening/major bleeding at at 12-month follow-up","time_frame":"12-month follow-up","description":"The composite endpoint of Incidence of death, MI, ischemic stroke/TIA or life threatening/major bleeding at at 12-month follow-up will be analyzed."},{"outcome_type":"secondary","measure":"Incidence of MI or ischemic stroke at 30 days and at 12-month follow-up","time_frame":"12-month follow-up","description":"The composite endpoint of incidence of MI or ischemic stroke at 30 days and at 12-month follow-up will be analyzed"},{"outcome_type":"secondary","measure":"Cardiovascular death at 30 days and at 12-month follow-up","time_frame":"30 days and at 12-month follow-up","description":"The incidence of cardiovascular death at 30 days and at 12-month follow-up will be analyzed"},{"outcome_type":"secondary","measure":"Cost-effectiveness of clopidogrel on top of aspirin/acetylsalicylic acid following TAVI","time_frame":"30 days and at 12-month follow-up","description":"Cost-effectiveness of clopidogrel on top of aspirin/acetylsalicylic acid following TAVI will be analyzed"},{"outcome_type":"secondary","measure":"Rate of minor bleeding at 30 days and at 12-month follow-up","time_frame":"30 days and at 12-month follow-up","description":"Rate of minor bleeding at 30 days and at 12-month follow-up will be analyzed"}]}
{"nct_id":"NCT02765373","start_date":"2015-01-31","enrollment":500,"brief_title":"Effects of Adjuvant Endocrine Therapy With Aromatase Inhibitors on the Postoperative Lipid Levels in Postmenopausal Breast Cancer Patients","primary_completion_date":"2020-01-31","study_type":"Observational","rec_status":"Unknown status","last_update":"2019-05-13","description":"This study is a prospective, controlled phase IV clinical trial among postmenopausal patients with hormone receptor-positive breast cancer.The main purpose is to compare the effects of steroidal aromatase inhibitor (AI) exemestane and non-steroidal AIs on the lipid levels of breast cancer patients.","other_id":"CH-BC-030","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"Female","minimum_age":60,"population":"postmenopausal women with hormone receptor-positive breast cancer who have received surgery","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Pathologic analysis verifies to be early-stage invasive breast cancer while\r\n             immunohistochemistry shows estrogen receptor(ER) and/or progesterone receptor(PR)\r\n             positive (ER/PR positive is defined that >1% of cells are positive).\r\n\r\n          2. The patients have received surgery for breast cancer and recovered well for an\r\n             interval of at least 1 week.\r\n\r\n          3. The patients have received post-operational adjuvant chemotherapy and/or adjuvant\r\n             radiotherapy whereas the interval of chemotherapy and/or adjuvant radiotherapy is more\r\n             than 2 weeks.\r\n\r\n          4. The postmenopausal women have been confirmed to be to menopausal as defined in NCCN\r\n             guidelines(including post bilateral oophorectomy; age60 year-old; age60 year-old,\r\n             menopause for more than 1 year and plasma Follicle-Stimulating Hormone (FSH) and\r\n             estradiol levels meet the menopausal scope).\r\n\r\n          5. Do not receive concomitant endocrine therapy, e.g. drug-induced menopause, tamoxifen.\r\n\r\n          6. The patients do not have severe cardiopulmonary dysfunction.\r\n\r\n          7. ECOG score: 0-1\r\n\r\n          8. The patients have enough organ function and meet the scope of aromatase\r\n             inhibitors(AIs) therapy. The laboratory test indexes must comply with the following\r\n             requirements:\r\n\r\n             Blood routine: neutrophil1.5G/L, platelet count 75G/L, hemoglobin 100g/L Liver\r\n             function: serum bilirubin  2 times the upper limit of normal value; ALT and AST3\r\n             times the upper limit of normal value; Renal function: serumcreatinine140mol/L\r\n\r\n          9. Serum low density lipoprotein-cholesterol(LDL-C) value <3.37mmol/L\r\n\r\n         10. Imaging examination identifies none of local recurrence or distal metastasis.\r\n\r\n         11. No other combined malignancy.\r\n\r\n         12. The patients have good compliance to the therapy and follow-up to be scheduled and are\r\n             able to understand the study protocol and sign the Informed Consent Form.\r\n\r\n        Exclusion criteria\r\n\r\n          1. The patients are not qualified to receive the adjuvant endocrine therapy with AIs.\r\n\r\n          2. The patients previously received other endocrine therapy (e.g. tamoxifen) simultaneity\r\n             or the treatment with AIs (excluding those with a course of less than 3 months)\r\n\r\n          3. The patients received or are receiving the lipid-lowering therapy.\r\n\r\n          4. The patients suffer from other combined malignancy.\r\n\r\n          5. The patients have uncontrollable mental illness.\r\n\r\n          6. The patients experience severe cardiovascular diseases in the recent 6 months (e.g.\r\n             unstable angina, chronic heart failure, uncontrollable hypertension >150/90 mmHg,\r\n             myocardial infarction or cerebrovascular disorders).\r\n      ","sponsor":"Chinese Academy of Medical Sciences","sponsor_type":"Other","conditions":"Breast Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Exemestane"},{"intervention_type":"Drug","name":"Drug: Letrozole"},{"intervention_type":"Drug","name":"Drug: Anastrozole"}],"outcomes":[{"outcome_type":"primary","measure":"Ratio of patients whose low density lipoprotein-cholesterol（LDL-C） level ≥ 4.14 mmol/L in 2 years of administration among groups","time_frame":"Change of LDL-C level from Baseline to up to 2 years"}]}
{"nct_id":"NCT03361488","start_date":"2015-01-31","phase":"N/A","enrollment":47,"brief_title":"Effect of Structured Patient Interviews in the Preoperative Anesthesia Clinic on Recall of Relevant Information","official_title":"Effect of Structured Patient Interviews in the Preoperative Anesthesia Clinic on Recall of Relevant Information","primary_completion_date":"2015-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-04-30","last_update":"2018-04-25","description":"The preanesthetic visit influences patient satisfaction and medical outcome. This study aims to evaluate whether training for a structured interview technique improves communication skills, resulting in increased recall of relevant information by surgical patients.","other_id":"SPI-RECALL","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Surgical patients in the preoperative anesthesia clinic\r\n\r\n          -  Written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Inadequate comprehension of the German language\r\n      ","sponsor":"Nicolai Goettel","sponsor_type":"Other","conditions":"Anesthesia|Surgical Procedure, Unspecified|Communication","interventions":[{"intervention_type":"Other","name":"Other: Trained anesthesiogist"}],"outcomes":[{"outcome_type":"primary","measure":"Recall of information","time_frame":"Immediately after patient interview","description":"Number of recalled information items in free text, expert assessment according to predefined Delphi criteria"}]}
{"nct_id":"NCT03568721","start_date":"2015-01-25","phase":"Phase 4","enrollment":81,"brief_title":"Postoperative Effects of Chewing Gum, Ibuprofen and Acetaminophen on Pain After Initial Archwire Placement","official_title":"Postoperative Effects of Chewing Gum, Ibuprofen and Acetaminophen on Pain After Initial Archwire Placement: a Randomized Controlled Trial","primary_completion_date":"2018-03-18","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-05-20","last_update":"2018-12-03","description":"The purpose of this study is to compare the efficacy of ibuprofen, acetaminophen, chewing gum in reducing orthodontic pain. This study include 81 patients to be classified into 4 groups of 19 each: ibuprofen (400 mg), acetaminophen (500 mg), chewing gum and control. The patients in each group will receive 1 method immediately after placement of the initial archwire and every 6 hours for a week if they experiences pain. Pain perception will be recorded by the patients while jaw rest position and fitting back teeth at 2 hours, 24 hours, 2 days, 3 days, 7 days and 21 days after archwire placement, using a visual analog scale.","other_id":"173112","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":12,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  moderate teeth crowding\r\n\r\n          -  no need for tooth extraction to orthodontic reasons\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  presence of autoimmune diseases\r\n\r\n          -  history of orthodontic treatment with fixed appliances\r\n      ","sponsor":"Rio de Janeiro State University","sponsor_type":"Other","conditions":"Pain","interventions":[{"intervention_type":"Drug","name":"Drug: Ibuprofen","description":"prescription of ibuprofen 400 mg"},{"intervention_type":"Drug","name":"Drug: Acetaminophen","description":"prescription of acetaminophen 500 mg"},{"intervention_type":"Other","name":"Other: Chewing gum","description":"prescription of one tablet of chewing gum"}],"outcomes":[{"outcome_type":"primary","measure":"Orthodontic pain measurement by marking 100 millimeters visual analogue scales.","time_frame":"2 hours, 24 hours, 2 days, 3 days, 7 days and 21 days after archwire placement.","description":"to compare the efficacy of ibuprofen, acetaminophen and chewing gum in changing orthodontic pain by marking in between two points in a 100 millimeters visual analogue scale that starts from the left (no pain) and end to the right (exacerbated pain) at different time points."},{"outcome_type":"secondary","measure":"Chewing gum as a non pharmacologic alternative for orthodontic pain control by marking 100 millimeters visual analogue scales.","time_frame":"2 hours, 24 hours, 2 days, 3 days, 7 days and 21 days after archwire placement.","description":"to verify if chewing gum can be a non-pharmacologic method for orthodontic pain control by marking in between two points in a 100 millimeters visual analogue scale that starts from the left (no pain) and ends to the right (exacerbated pain) at different time points."},{"outcome_type":"secondary","measure":"Pain at rest X fitting back teeth by marking 100 millimeters visual analogue scales.","time_frame":"2 hours, 24 hours, 2 days, 3 days, 7 days and 21 days after archwire placement.","description":"to verify wich group has less pain and if in rest or in fitting back teeth by marking in between two points in a 100 millimeters visual analogue scale that starts from the left (no pain) and end to the right (exacerbated pain) at different time points."}]}
{"nct_id":"NCT02283372","start_date":"2015-01-21","phase":"Phase 1","enrollment":30,"brief_title":"Nab-Paclitaxel Plus Gemcitabine With Concurrent MR-Guided IMRT in Patients With Locally Advanced Pancreatic Cancer","official_title":"Prospective Phase I Study of Nab-Paclitaxel Plus Gemcitabine With Concurrent MR-Guided IMRT in Patients With Locally Advanced Pancreatic Cancer","primary_completion_date":"2018-05-14","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-04-18","last_update":"2019-06-19","description":"A phase I study to evaluate safety of gemcitabine with nab-paclitaxel and concurrent IMRT for locally advanced and borderline resectable pancreatic cancer. The goal of this study is to evaluate if a chemotherapy regimen that provides superior systemic efficacy may be safely delivered and enhance efficacy of tumor directed radiation therapy.","other_id":"201412038","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically or cytologically confirmed locally advanced adenocarcinoma of the\r\n             pancreas that is considered unresectable or borderline resectable based on\r\n             institutional standardized criteria of unresectability or medical inoperability.\r\n             Patients with and without regional adenopathy are eligible.\r\n\r\n          -  Prior systemic chemotherapy allowed. It is anticipated and suggested that most\r\n             patients enrolled on study will have received a minimum of approximately 2 months of\r\n             systemic therapy according to routine institutional practices. The patient must also\r\n             be felt by the treating medical oncologist and radiation oncologist to be a candidate\r\n             for treatment with gemcitabine/nab-paclitaxel chemoradiotherapy.\r\n\r\n          -  At least 18 years of age.\r\n\r\n          -  ECOG performance status  1\r\n\r\n          -  Normal bone marrow and organ function as defined below:\r\n\r\n               -  Absolute neutrophil count  1,000/mcl\r\n\r\n               -  Platelets  100,000/mcl\r\n\r\n               -  Hemoglobin  9.0 g/dL\r\n\r\n               -  Total bilirubin  1.5 x ULN\r\n\r\n               -  AST(SGOT)/ALT(SGPT)  1.5 x IULN\r\n\r\n               -  Serum creatinine  1.5 mg/dL or calculated CrCL>60mL/min using Cockcroft and\r\n                  Gault formula\r\n\r\n          -  Women of childbearing potential and men must agree to use adequate contraception\r\n             (hormonal or barrier method of birth control, abstinence) prior to study entry and for\r\n             the duration of study participation. Should a woman become pregnant or suspect she is\r\n             pregnant while participating in this study, she must inform her treating physician\r\n             immediately.\r\n\r\n          -  Ability to understand and willingness to sign an IRB approved written informed consent\r\n             document (or that of legally authorized representative, if applicable).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Distant metastatic disease, including known brain metastases.\r\n\r\n          -  History of prior malignancy is acceptable, but prior radiotherapy to the region of the\r\n             study cancer that would result in overlap of radiation therapy fields is not allowed.\r\n\r\n          -  Currently receiving any other investigational agents.\r\n\r\n          -  Major surgery within 4 weeks prior to first study drug administration.\r\n\r\n          -  A history of allergic reactions attributed to compounds of similar chemical or\r\n             biologic composition to gemcitabine or nab-paclitaxel or other agents used in the\r\n             study.\r\n\r\n          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active\r\n             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac\r\n             arrhythmia, or psychiatric illness/social situations that would limit compliance with\r\n             study requirements.\r\n\r\n          -  Pregnant and/or breastfeeding. Patient must have a negative pregnancy test within 14\r\n             days of study entry.\r\n\r\n          -  Known HIV-positivity on combination antiretroviral therapy because of the potential\r\n             for pharmacokinetic interactions with gemcitabine and nab-paclitaxel. In addition,\r\n             these patients are at increased risk of lethal infections when treated with\r\n             marrow-suppressive therapy. Appropriate studies will be undertaken in patients\r\n             receiving combination antiretroviral therapy when indicated.\r\n      ","sponsor":"Washington University School of Medicine","sponsor_type":"Other","conditions":"Pancreatic Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: nab-Paclitaxel"},{"intervention_type":"Drug","name":"Drug: Gemcitabine"},{"intervention_type":"Radiation","name":"Radiation: Intensity modulated radiation"}],"outcomes":[{"outcome_type":"primary","measure":"Maximum tolerated dose (MTD)","time_frame":"Completion of toxicity follow-up for all patients (up to 32 months)","description":"For the toxicity endpoint purposes of this trial, the patient will be followed from start of treatment until the patient completes 60 days of follow-up from the start of radiation therapy, has a dose-limiting toxicity (DLT), or is lost to follow-up."},{"outcome_type":"secondary","measure":"Rate of conversion of patients with locally advanced pancreatic cancer or borderline resectable to resectable","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Local control (Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)","time_frame":"1 year","description":"Local control is absence of tumor progression.\r\nResponse and progression will be evaluated in this study using the new international criteria proposed by the revised\r\nProgressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions)."},{"outcome_type":"secondary","measure":"Progression-free survival (PFS)","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Overall survival (OS)","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Quality of life as measured by the EORTC QLQ-C30","time_frame":"3 months after completion of treatment (up to 18 weeks)","description":"The EORTC QLQ-C30 questionnaire will be utilized."},{"outcome_type":"secondary","measure":"Frequency of RT adaptation based on MR guidance","time_frame":"3 months after completion of treatment (up to 18 weeks)","description":"The rate at which a change or adaptation to the patient's plan is made based on significant change in anatomy observed on localization MRI. This is defined as [#of treatment adaptations required]/[total # of RT treatments]"}]}
{"nct_id":"NCT02519738","start_date":"2015-01-15","phase":"Phase 3","enrollment":52,"brief_title":"Granulation Tissue Treatment: Silver Nitrate vs Kenalog vs Washcloth Abrasion","official_title":"Granulation Tissue at G Tube Site: Treatment With Kenalog vs Chemical Cauterization With Silver Nitrate vs Soap Washcloth Abrasion","primary_completion_date":"2018-11-13","study_type":"Interventional","rec_status":"Terminated","completion_date":"2018-11-13","last_update":"2021-01-14","description":"Granulation tissue, or excess tissue, forms around gastrostomy tube sites and is a common problem seen in the pediatric surgery population. There is no standard treatment that has been identified in clinical practice to treat granulation tissue effectively. Clinicians prescribe treatments of varying nature to help treat this condition. By conducting this study, the investigators hope to identify if there is any difference in the treatment groups and if there is any superiority for one treatment over the other. The three arms in the study are Silver Nitrate treatment, treatment with Kenalog, and Washcloth abrasion. Treatments will continue over a period of three weeks, and the progress will be followed using surveys and photographs.","other_id":"HUM00077762","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","maximum_age":17,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Any patient falling within age group with granulation tissue around G tube site\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients falling outside of age group range\r\n      ","sponsor":"University of Michigan","sponsor_type":"Other","conditions":"Other Abnormal Granulation Tissue Nos","interventions":[{"intervention_type":"Drug","name":"Drug: Silver Nitrate","description":"Silver nitrate to be applied 3 times weekly for a period of 3 weeks."},{"intervention_type":"Drug","name":"Drug: Kenalog (Triamcinolone)","description":"Triamcinolone will be applied as an ointment to the granulation tissue site three times daily for a total of three weeks."},{"intervention_type":"Other","name":"Other: Washcloth Abrasion","description":"Gentle wash and abrasion with washcloth done once daily for a total of 3 weeks."}],"outcomes":[{"outcome_type":"primary","measure":"Decrease in size (mm) of granulation tissue","time_frame":"8 weeks","description":"Measurements are calculated from photographs taken with a millimeter ruler next to granulation tissue on a horizontal plane and a vertical plane."}]}
{"nct_id":"NCT02326324","start_date":"2015-01-05","enrollment":10000,"brief_title":"The UHSM Cardiovascular Magnetic Resonance Study","official_title":"The University Hospital of South Manchester Cardiovascular Magnetic Resonance Study","primary_completion_date":"2029-12-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2029-12-31","last_update":"2021-09-21","description":"This study aims to investigate the diagnostic and prognostic utility of cardiovascular magnetic resonance (CMR) imaging in a large cohort of unselected patients who are undergoing CMR scanning for clinical indications (i.e. suspected/confirmed cardiovascular disease). CMR indices will be related to the presence and severity of cardiovascular disease and other markers of cardiovascular and health status.","other_id":"14/NW/1165","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients undergoing clinically indicated CMR scanning (i.e. patients with suspected or\r\n        confirmed cardiovascular disease)","criteria":"\n        Inclusion Criteria:\r\n\r\n        Any adult patient undergoing clinically indicated CMR scanning at the UHSM CMR Unit.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Age < 18 years, imprisonment, inability to provide informed consent.\r\n      ","sponsor":"Manchester University NHS Foundation Trust","sponsor_type":"Other","conditions":"Cardiovascular Diseases","interventions":{},"outcomes":[{"outcome_type":"secondary","measure":"Development of cardiovascular disease","time_frame":"10 years with planned interim analyses"},{"outcome_type":"secondary","measure":"Development of complications of cardiovascular disease","time_frame":"10 years with planned interim analyses"},{"outcome_type":"primary","measure":"All cause mortality","time_frame":"10 years with planned interim analyses"},{"outcome_type":"secondary","measure":"Cardiovascular death","time_frame":"10 years with planned interim analyses"},{"outcome_type":"secondary","measure":"Hospitalisation for heart failure","time_frame":"10 years with planned interim analyses"}]}
{"nct_id":"NCT02302417","start_date":"2015-01-01","phase":"Phase 2","enrollment":1215,"brief_title":"Study Assessing Utility of a Clinical Questionnaire to Identify Subjects With Features of Both Asthma and Chronic Obstructive Pulmonary Disease (COPD)","official_title":"The Utility of a Clinical Questionnaire to Identify Subjects With Features of Both Asthma and COPD","primary_completion_date":"2015-05-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-05-28","last_update":"2017-09-11","description":"The primary objective of the study is to identify demographic and non-spirometric clinical features predictive of the asthma-COPD overlap population. The study aims to explore and identify characteristics of the Asthma-COPD Overlap Syndrome (ACOS) patient's clinical profile that enable clinical differentiation from subjects with a primary diagnosis of either asthma alone (without persistent obstruction) or COPD alone (without reversibility). The study is designed as a targeted medical history survey which consists of a 41-item questionnaire, which will be administered by a qualified health care practitioner at the time a subject's medical history is taken. The questionnaire has been developed to elicit specific details of the respiratory history, including the following: bronchodilator use, disease progression, variation in symptoms, atopic history, symptom triggers, vagal bias, burden of disease, symptom presentation, co morbidities and age of onset. In addition, demographic information, standard medical history, co morbidity and spirometric results will also be obtained and analyzed in conjunction with the questionnaire results. Approximately 1000 subjects are required for the study.","other_id":"201703","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subject must be 18 years of age or older.\r\n\r\n          -  Subject has been diagnosed as having asthma and/or COPD.\r\n\r\n          -  Informed consent is required for independent sites initiating this protocol\r\n      ","sponsor":"GlaxoSmithKline","sponsor_type":"Industry","conditions":"Pulmonary Disease, Chronic Obstructive","interventions":[{"intervention_type":"Procedure","name":"Procedure: Spirometry","description":"Classification of respiratory diseases by Spirometry will be performed to differentiate subjects between Asthma only, ACOS, and COPD only. Spirometry obtained from measurements in the past 6 months is acceptable for purposes of this study. For subjects without spirometry in the past 6 months, spirometry will be performed to obtain pre- and post-bronchodilator Forced Expiratory Volume in one second (FEV1), Forced Vital Capacity (FVC) and reversibility"},{"intervention_type":"Other","name":"Other: ACOS clinical questionnaire","description":"The 41-question questionnaire includes questions concerning the following: a) response to bronchodilator, b) disease progression, c) variations in symptom, d) atopic history, e) symptom triggers, f) vagal bias, g) burden of disease, h) symptom presentation, i) emotional aspects, and j) age of onset. In addition, two questions will capture patient perception of his/her respiratory disease and the physician's diagnosis"}],"outcomes":[{"outcome_type":"primary","measure":"Summary of spirometry data: forced expiratory volume in one second (FEV1) and forced vital capacity (FVC)","time_frame":"Day 1","description":"FEV1 measures how much air a person can exhale during a forced breath in 1 second. FVC is the total amount of air exhaled during the FEV test. FEV1 and FVC were performed on Day 1 (pre- and post-bronchodilator) using spirometry. Spirometry results obtained within 6 months and were used for this study. For participants without spirometry in the past 6 months, spirometry was performed to obtain pre- and post-bronchodilator FEV1, FVC."},{"outcome_type":"primary","measure":"Summary of spirometry data: Reversibility","time_frame":"Day 1","description":"Questionnaire designed to clinically differentiate participants with ACOS from patients who have either asthma alone (i.e. without persistent obstruction) or COPD alone (i.e., non-reversible). Spirometry results obtained within 6 months and were used for this study. For participants without spirometry in the past 6 months, spirometry was performed to obtain pre- and post-bronchodilator FEV1, FVC and reversibility."},{"outcome_type":"primary","measure":"Number of participants with response to Bronchodilators (Questionnaire Items 1 and 2)","time_frame":"Day 1","description":"ACOS Medical history questionnaire is a disease specific (asthma and/or COPD) questionnaire administered by a qualified health care practitioner to assess the clinical features of asthma and/or COPD. Items were grouped in 10 different domains. Response to bronchodilators was one domain in which, participants had to answer questions (Q)1-2 (Q1: How well does your participant's quick relief inhaler (rescue inhaler) provide symptom relief? and Q2: How often does the participant need to keep a rescue inhaler with him/her?) regarding rescue inhaler and need to keep inhaler with participants Responses were recorded as No relief, Relief and No need, Need. Number of participants with such responses were recorded."},{"outcome_type":"primary","measure":"Number of participants with disease progression (Questionnaire Item 3)","time_frame":"Day 1","description":"ACOS Medical history questionnaire is a disease specific (asthma and/or COPD) questionnaire administered by a qualified health care practitioner to assess the clinical features of asthma and/or COPD. Items were grouped in 10 different domains. Disease progression was one domain in which, participants had to answer question (Q3: How does the participant describe his/her respiratory disease over the past two (2) years?) regarding disease progression over the past two years with responses like: getting worse or same/some better/some worse. Number of participants with such responses were recorded."},{"outcome_type":"primary","measure":"Number of participants with Variation in symptoms (Questionnaire Items 4-10)","time_frame":"Day 1","description":"ACOS Medical history questionnaire is a disease specific (asthma and/or COPD) questionnaire administered by a qualified health care practitioner to assess the clinical features of asthma and/or COPD. Items were grouped in 10 different domains. Variation in symptoms was one domain in which, participants had to answer questions 4 to 10 which included questions regarding respiratory symptoms, night-time awakenings due to symptoms, respiratory symptoms during day and night, good/bad days regard to breathing, good and bad days difference, how quickly a good day changes to bad, how long until the bad respiratory symptoms return to normal. Number of participants with such responses were reported."},{"outcome_type":"primary","measure":"Number of participants with atopic history (Questionnaire Items 11 and 12)","time_frame":"Day 1","description":"ACOS Medical history questionnaire is a disease specific (asthma and/or COPD) questionnaire administered by a qualified health care practitioner to assess the clinical features of asthma and/or COPD. Items were grouped in 10 different domains. Atopic history was one domain in which, participants had to answer questions 11 and 12 (Q11: Has the participant ever had nasal allergies or eczema? and Q12: How many members of the participant's immediate biological family have had asthma, nasal allergies, or eczema? )which included questions regarding nasal allergies or eczema and how many members of the participant's immediate biological family had asthma, nasal allergies, or eczema. Number of participants with responses to these questions were reported."},{"outcome_type":"primary","measure":"Number of participants with atopic history (Questionnaire Items 13-15)","time_frame":"Day 1","description":"ACOS Medical history questionnaire is a disease specific (asthma and/or COPD) questionnaire administered by a qualified health care practitioner to assess the clinical features of asthma and/or COPD. Items were grouped in 10 different domains. Atopic history was one domain in which, participants had to answer questions 13-15 (Q13: Do the subject's respiratory symptoms get worse after exposure to pollen or pets?, Q14: Do the subject's respiratory symptoms get worse after exposure to cold air or weather changes?, Q15: Do the subject's respiratory symptoms get worse with exposure to air pollution or noxious fumes? ). Responses of participants as yes or no were recorded for these questions."},{"outcome_type":"primary","measure":"Number of participants with vagal bias (Questionnaire Items 16 and 17)","time_frame":"Day 1","description":"ACOS Medical history questionnaire is a disease specific (asthma and/or COPD) questionnaire administered by a qualified health care practitioner to assess the clinical features of asthma and/or COPD. Items were grouped in 10 different domains. vagal bias was one domain in which, participants had to answer questions 16 and 17 (Q16: Does the participant react emotionally to distress (e.g., cry easily during a sad film)?, Q17: How much of an impact does emotional distress have on the participant's respiratory symptoms? ). Number of participants with response to these questions were reported."},{"outcome_type":"primary","measure":"Number of participants with burden of disease (Questionnaire Items 18-24)","time_frame":"Day 1","description":"ACOS Medical history questionnaire is a disease specific questionnaire to assess the clinical features of asthma and/or COPD. Items were grouped in 10 different domains. Burden of disease was a domain in which, participants had to answer questions 18-24 (Q18: If the participant stops taking his/her regular respiratory medications, how do his/her respiratory symptoms change?, Q19: How many days in a week does the participant typically have respiratory symptoms during the day?, Q20: How often does the participant typically have respiratory symptoms at night?, Q21: On average how frequently does the participant use rescue medication?, Q22: How often do the participant's respiratory symptoms disturb their sleep?, Q23: How much impact do the participant's respiratory symptoms have on their energy level?, Q24: How often would the participant describe themselves as feeling anxious?). Number of participants with response to these questions were reported."},{"outcome_type":"primary","measure":"Number of participants with symptom presentation (Questionnaire Items 25-34)","time_frame":"Day 1","description":"ACOS Medical history questionnaire is a disease specific (asthma and/or COPD) questionnaire administered by a qualified health care practitioner to assess the clinical features of asthma and/or COPD. Items were grouped in 10 different domains. Burden of disease was one domain in which, participants had to answer questions 25-34 which included questions regarding presentation of symptoms like cough, breathlessness, sputum production. Responses to these questions were recorded. Question 33 was a 5 part question with cough, breathlessness, sputum production as the most bothersome symptom (MBS) Number of participants with responses to the questions were reported."},{"outcome_type":"primary","measure":"Number of participants with emotional response by Sex (Questionnaire Items 35 and 36)","time_frame":"Day 1","description":"ACOS Medical history questionnaire is a disease specific (asthma and/or COPD) questionnaire administered by a qualified health care practitioner to assess the clinical features of asthma and/or COPD. Items were grouped in 10 different domains. Emotional Response was one domain in which, participants had to answer questions 35-36 (Q35: How often would the participant describe themselves as feeling depressed?, Q36: How scared or worried is the participant about his/her lung function?)for males and females was collected and number of participants with responses were reported."},{"outcome_type":"primary","measure":"Summary of age of onset (Questionnaire Items 37 and 38)","time_frame":"Day 1","description":"ACOS Medical history questionnaire is a disease specific (asthma and/or COPD) questionnaire administered by a qualified health care practitioner to assess the clinical features of asthma and/or COPD. Items were grouped in 10 different domains. Age of onset was one domain in which, participants had to answer questions 37 and 38 (Q37: How old was the participant when he/she first used an inhaler (for asthma or COPD)?, Q38: How old was the participant when he/she first used an inhaled corticosteroid on a regular basis for his/her respiratory condition (asthma or COPD)?). Least square mean was presented."},{"outcome_type":"primary","measure":"Number of participants with perception of respiratory disease (Questionnaire Items 39-40)","time_frame":"Day 1","description":"ACOS Medical history questionnaire is a disease specific (asthma and/or COPD) questionnaire administered by a qualified health care practitioner to assess the clinical features of asthma and/or COPD. Items were grouped in 10 different domains. Patient Perception of respiratory disease was one domain in which, participants had to answer questions 39-40 (Q39: Does the participants consider themselves to have asthma, COPD or both?, Q40: Does this participants have asthma, COPD or both?). Number of participants with both responses were collected and presented."},{"outcome_type":"primary","measure":"Number of participants with clinical features most helpful in diagnosis (Questionnaire Item 41)","time_frame":"Day 1","description":"ACOS Medical history questionnaire is a disease specific (asthma and/or COPD) questionnaire administered by a qualified health care practitioner to assess the clinical features of asthma and/or COPD. Items were grouped in 10 different domains. clinical features most helpful in diagnosis was one domain in which, participants had to answer question item 41 which was regarding various clinical features like age of onset, symptom presentation, variation in symptoms, timing of symptoms, symptom persistence, previous environmental exposure, tobacco smoking history, airflow limitation variability, lung function measures, nature of disease, previous doctor diagnosis, family history, response to short-acting bronchodilator, response to inhaled corticosteroid (ICS), chest x-ray findings, symptom triggers. Number of participants with responses to these questions were reported."}]}
{"nct_id":"NCT04343118","start_date":"2015-01-01","enrollment":30,"brief_title":"Benefit of Surgical Hardware Removal Following Clavicle Fracture","official_title":"Do Patients Benefit From Elective Implant Removal Following Plate Osteosynthesis of Clavicle Fractures - a Prospective Trial","primary_completion_date":"2020-01-01","study_type":"Observational","rec_status":"Completed","completion_date":"2020-01-02","last_update":"2020-04-13","description":"Little is known about the beneficial aspects of elective implant removal following plate osteosynthesis of displaced clavicle fractures.","other_id":"089_2019ME","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":100,"population":"Patients requesting implant removal","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  age >18 years\r\n\r\n          -  Radiologically consolidated clavicle fracture\r\n\r\n          -  following ORIF using a superior anatomically preformed locking plate\r\n\r\n          -  asking for elective implant removal\r\n\r\n          -  written informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnancy\r\n\r\n          -  Under-aged\r\n\r\n          -  Delinquent patients.\r\n      ","sponsor":"Technische Universitt Mnchen","sponsor_type":"Other","conditions":"Clavicle Fracture","interventions":[{"intervention_type":"Procedure","name":"Procedure: Hardware Removal","description":"elective removal of plate osteosynthesis at the clavicle"}],"outcomes":[{"outcome_type":"primary","measure":"Shoulder function","time_frame":"6 Week post surgery","description":"Munich Shoulder Questionnaire allowing for calculation of Constant Score (0-100), Dash (0-100)"}]}
{"nct_id":"NCT02430636","start_date":"2015-01-01","phase":"N/A","enrollment":30,"brief_title":"Irreversible Electroporation(IRE) For Unresectable Stomach Neoplasms","official_title":"Irreversible Electroporation(IRE) For Unresectable Stmoach Neoplasms: Phase I and Phase II Clinical Trial","primary_completion_date":"2020-12-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2021-02-01","last_update":"2021-09-05","description":"The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Stomach Neoplasms.","other_id":"Stomach Neoplasms -IRE-01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Stomach Neoplasms diagnosed by positive biopsy or non-invasive criteria,\r\n\r\n          -  Not suitable for surgical resection,\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) score of 0-1,\r\n\r\n          -  A prothrombin time ratio > 50%,\r\n\r\n          -  Platelet count > 80x10^9/L,\r\n\r\n          -  Ability of patient to stop anticoagulant and anti-platelet therapy for seven days\r\n             prior to and seven days post NanoKnife procedure,\r\n\r\n          -  Able to comprehend and willing to sign the written informed consent form (ICF),\r\n\r\n          -  Have a life expectancy of at least 3 months.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,\r\n\r\n          -  Any active implanted device (eg Pacemaker),\r\n\r\n          -  Women who are pregnant or women of child-bearing potential who are not using an\r\n             acceptable method of contraception,\r\n\r\n          -  Have received treatment with an investigational agent/ procedure within 30 days prior\r\n             to treatment with the NanoKnife LEDC System,\r\n\r\n          -  Are in the opinion of the Investigator unable to comply with the visit schedule and\r\n             protocol evaluations.\r\n      ","sponsor":"Fuda Cancer Hospital, Guangzhou","sponsor_type":"Other","conditions":"Stomach Neoplasms","interventions":[{"intervention_type":"Procedure","name":"Procedure: Irreversible electroporation (IRE)","description":"Irreversible Electroportion For Unresectable Stomach Neoplasms guide with ultrasound or/and CT."},{"intervention_type":"Device","name":"Device: NanoKnife"}],"outcomes":[{"outcome_type":"primary","measure":"Number of participants with Adverse events","time_frame":"6 month"},{"outcome_type":"secondary","measure":"Percentage of lesions that show no sign of recurrence 12 months after IRE","time_frame":"12 months"},{"outcome_type":"secondary","measure":"A minimum and maximum range of voltage for safe and effective IRE","time_frame":"3 months"},{"outcome_type":"secondary","measure":"Progress free disease (PFS)","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Overall survival (OS)","time_frame":"36 months","description":"Patients will be followed for 36 months after IRE for OS analyzed."}]}
{"nct_id":"NCT02398136","start_date":"2014-12-31","phase":"Phase 2/Phase 3","enrollment":0,"brief_title":"To Test the Potential Efficacy of Repeated Intranasal Administration of Ketamine as a Treatment for PTSD","official_title":"Randomized Controlled Trial of Repeated Dose Ketamine in Post Traumatic Stress Disorder (PTSD)","primary_completion_date":"2014-12-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2014-12-31","last_update":"2015-03-25","description":"The purpose of this study is to see whether ketamine, when given repeatedly via the nose (intranasally), can produce a quick and persistent improvement in PTSD symptoms. At higher doses, ketamine has been used for many years as an anesthetic for medical procedures, and at lower doses may be an effective treatment in patients with major depression and PTSD.","other_id":"GCO 14-1781","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Men or women, 18-65 years of age;\r\n\r\n          -  Participants must have a level of understanding sufficient to agree to all tests and\r\n             examinations required by the protocol and must sign a written informed consent\r\n             document;\r\n\r\n          -  Participants must fulfill DSM-5 criteria for current civilian or combat-related PTSD,\r\n             based on clinical assessment by a study psychiatrist and on the CAPS -this is done to\r\n             ensure at least moderate severity and to safeguard against high placebo response\r\n             rates;\r\n\r\n          -  Women must be using a medically accepted reliable means of contraception (if using an\r\n             oral contraceptive medication, they must also be using a barrier contraceptive) or not\r\n             be of childbearing potential (i.e., surgically sterile, postmenopausal for at least\r\n             one year);\r\n\r\n          -  Women of childbearing potential must have a negative pregnancy test at screening and\r\n             prior to each intranasal administration;\r\n\r\n          -  Participants must be able to identify a family member, physician, or friend (i.e.\r\n             someone who knows them well) who will participate in a Treatment Contract (and e.g.\r\n             contact the study physician on their behalf in case manic symptoms or suicidal\r\n             thoughts develop).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Women who plan to become pregnant, are pregnant or are breast-feeding (because the\r\n             medical risk of using ketamine during pregnancy and breast-feeding is unknown);\r\n\r\n          -  Serious, unstable medical illnesses such as hepatic, renal, gastroenterologic,\r\n             respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic\r\n             disease, including gastro-esophageal reflux disease, obstructive sleep apnea, history\r\n             of difficulty with airway management during previous anesthetics, ischemic heart\r\n             disease and uncontrolled hypertension, and history of severe head injury;\r\n\r\n          -  Clinically significant abnormal findings of laboratory parameters, physical\r\n             examination, or ECG;\r\n\r\n          -  Patients with uncorrected hypothyroidism or hyperthyroidism;\r\n\r\n          -  Hormonal treatment (e.g., estrogen) started in the 3 months prior to the first\r\n             intranasal administration day;\r\n\r\n          -  Use of evidence-based individual psychotherapy (such as prolonged exposure) during the\r\n             study;\r\n\r\n          -  History of autism, mental retardation, pervasive developmental disorders, or\r\n             Tourette's syndrome;\r\n\r\n          -  History of one or more seizures without a clear and resolved etiology;\r\n\r\n          -  History of (hypo)mania;\r\n\r\n          -  Past or current presence of psychotic symptoms, or diagnosis of a lifetime psychotic\r\n             disorder including schizophrenia or schizoaffective disorder;\r\n\r\n          -  Drug or alcohol abuse or dependence within the preceding 3 months; a rather narrow\r\n             time period was chosen, however, in order to allow participation by individuals with a\r\n             history of substance abuse or dependence problems that could be secondary to their\r\n             PTSD, and to more closely approximate patients seen in real-world settings; this is\r\n             the same period of time that we used in our recently completed study of IV ketamine\r\n             for PTSD.\r\n\r\n          -  Previous recreational use of ketamine or PCP;\r\n\r\n          -  Current diagnosis of bulimia nervosa or anorexia nervosa;\r\n\r\n          -  Diagnosis of schizotypal or antisocial personality disorder (since these are known to\r\n             reduce the possibility of study completion); other Axis II diagnoses will be allowed;\r\n\r\n          -  Patients judged clinically to be at serious and imminent suicidal or homicidal risk.\r\n\r\n          -  A blood pressure of one reading over 160/90 or two separate readings over 140/90 at\r\n             screen or baseline visits\r\n\r\n          -  Patients who report current treatment with a benzodiazepine, an opioid medication, or\r\n             a mood stabilizer (such as valproic acid or lithium) within 2 weeks prior to\r\n             randomization; patients taking stable doses of antidepressant medication for 3 months\r\n             prior to randomization will be allowed.\r\n\r\n          -  For subjects who may participate in the MRI portion of the study, claustrophobia, any\r\n             trauma or surgery which may have left magnetic material in the body, magnetic implants\r\n             or pacemakers, and inability to lie still for 1 hour or more.\r\n      ","sponsor":"Adriana Feder","sponsor_type":"Other","conditions":"PTSD","interventions":[{"intervention_type":"Drug","name":"Drug: Ketamine"},{"intervention_type":"Drug","name":"Drug: Midazolam"}],"outcomes":[{"outcome_type":"primary","measure":"Impact of Events Scale-Revised (IES-R)","time_frame":"24 hours","description":"The IES-R is used to self-report measures of stress reactions to traumatic events. It measures both intrusion and avoidance."},{"outcome_type":"secondary","measure":"Clinician Administered PTSD Scale (CAPS)","time_frame":"up to 4 weeks","description":"The CAPS is a structured clinical interview designed to assess the essential features of PTSD."},{"outcome_type":"secondary","measure":"Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR)","time_frame":"24 hours","description":"The QIDS-SR is a 16-item self-rated instrument designed to assess the severity of depressive symptoms present in the past seven days."},{"outcome_type":"secondary","measure":"Montgomery Asberg Depression Rating Scale (MADRS)","time_frame":"24 hours","description":"The MADRS is a 10-item instrument used for the evaluation of depressive symptoms and for the assessment of any changes to those symptoms."},{"outcome_type":"secondary","measure":"Patient-Rated Inventory of Side Effects (PRISE)","time_frame":"24 hours","description":"PRISE is a 7-item self report used to qualify side effects by identifying and evaluating the tolerability of each symptoms."},{"outcome_type":"secondary","measure":"Sheehan Disability Scale (SDS)","time_frame":"24 hours","description":"The SDS is a 10 point visual analog scale developed to assess functional impairment."}]}
{"nct_id":"NCT02232191","start_date":"2014-12-31","phase":"Phase 2","enrollment":90,"brief_title":"Immunologic Response to Pneumococcal Polysaccharide Vaccine in Splenic Injury Patients","official_title":"Immunologic Response to Pneumococcal Polysaccharide Vaccine in Splenic Injury Patients","primary_completion_date":"2021-09-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-09-02","last_update":"2020-11-02","description":"Persons without a spleen are susceptible to potentially lethal infections from certain bacteria, with pneumococcus being the most prevalent. Vaccines are provided to help protect against these infections, though they do not so with certainty. Trauma patients who sustain an injury to their spleen currently have three treatment options available for the treating surgeon - nonoperative management, embolization, or removal of the spleen. The purpose of this study is to investigate the antibody response to pneumococcal vaccine in patients undergoing these modes of therapy.","other_id":"1036320","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adult trauma patients (aged 18 to 65 years old) sustaining a splenic injury.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Ages less than 18 and greater than 65\r\n\r\n          -  Initial planned nonoperative management patient who subsequently undergoes\r\n             embolization or splenectomy will be withdrawn from the study.\r\n      ","sponsor":"University of California, Davis","sponsor_type":"Other","conditions":"Asplenia","interventions":[{"intervention_type":"Biological","name":"Biological: Pneumovax-23"}],"outcomes":[{"outcome_type":"primary","measure":"Geometric mean increases in pneumococcal antibody titer","time_frame":"4 weeks","description":"measured by opsonophagocytosis assay"}]}
{"nct_id":"NCT02294838","start_date":"2014-12-31","phase":"N/A","enrollment":10,"brief_title":"Feasibility Study of MRI Imaging on Parotid Gland Stimulation","official_title":"Feasibility Study of MRI Imaging on Parotid Gland Stimulation","primary_completion_date":"2015-08-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2017-02-28","last_update":"2016-11-28","description":"The aim of this study is to determine the feasibility of demonstrating the following physiologically-descriptive quantities ('metrics'): the volume of plasma/volume of tissue (p), Apparent Diffusion Coefficient (ADC), the volume of extracellular extravascular space per volume of tissue (e), and the contrast agent transfer coefficients (Ktrans) pre and post parotid stimulation in 10 healthy volunteers. Feasibility will be defined as 80% of volunteers achieving detectable signal changes in pre/post salivary MR images.","other_id":"BCCA H14-02236","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Age  18 Healthy normal volunteer\r\n\r\n        Exclusion Criteria:\r\n\r\n        Pregnant women Scheduled to take unusual or uncommon chemotherapy agents or medication\r\n        Previous or about to undertake a course of radiotherapy Previous surgery to neck such as a\r\n        lymph node dissection. Must not have, or be willing to replace, metal fillings or other\r\n        foreign objects which will seriously impede image collection or analysis.\r\n\r\n        No contraindication to an MRI\r\n      ","sponsor":"British Columbia Cancer Agency","sponsor_type":"Other","conditions":"Parotid Neoplasms","interventions":[{"intervention_type":"Device","name":"Device: MRI","description":"Participants will undergo MR imaging of the parotid gland pre and post stimulation. Perfusion images will be acquired using a time-resolved, spoiled GE sequence with 112 mm spatial resolution, approximately one second 3D temporal resolution, and image technique/contrast parameters TR = 2.8 ms and TE = 0.9 ms."},{"intervention_type":"Other","name":"Other: Citric acid","description":"5 mls of 2% citric Acid will be delivered to the oral cavity via a syringe and Tygon tubing at two separate time intervals in order to stimulate the parotid gland during the MRI scanning process."},{"intervention_type":"Other","name":"Other: Gadovist","description":"Upon commencement of the scan, 0.05 ml/kg of Gadovist (at 4 ml/s) and 20 ml of saline flush (also at 4 ml/s) will be administered."}],"outcomes":[{"outcome_type":"primary","measure":"Feasibility study of MRI imaging on parotid gland stimulation.","time_frame":"time to recruit 10 healthy volunteers (approximately 4 months)","description":"Feasibility will be defined as 80% of volunteers achieving detectable signal changes in pre/post salivary stimulation MR images. The following physiologically-descriptive quantities ('metrics') will be measured: the volume of plasma/volume of tissue (νp), Apparent Diffusion Coefficient (ADC), the volume of extracellular extravascular space per volume of tissue (νe), and the contrast agent transfer coefficients (Ktrans) pre and post parotid stimulation."}]}
{"nct_id":"NCT02277171","start_date":"2014-12-31","phase":"Phase 1","enrollment":15,"brief_title":"Evaluation of Safety and Tolerability of Nitric Oxide Impregnated Urinary Catheters","official_title":"Prospective, Phase I, Single-Center, Evaluation of the Safety and Tolerability of Nitric Oxide Impregnated Urinary Catheters in Patients Undergoing Radical Prostatectomy","primary_completion_date":"2015-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-09-30","last_update":"2015-12-24","description":"According to the World Health Organization, hundreds of millions of patients are affected by health-care associated infections worldwide each year, resulting in prolonged hospital stays, long-term disabilities, deaths, and financial losses for health systems. The most common hospital-acquired infection is Urinary Tract Infection (UTI), accounting for almost 40% of all nosocomial infections. Most hospital-acquired UTIs are associated with catheterization. In fact, urinary catheter-related bacteriuria is the most common health care associated infection worldwide. Catheter-associated UTI (CAUTI) develops following adhesion of planktonic bacteria to the surface of the catheter and colonization, creating a persistent environment called a biofilm. The nature of biofilm structure together with the physiological attributes of biofilm organisms confers an inherent resistance to various antimicrobial agents such as antibiotics, disinfectants or germicides, augmenting the potential of these pathogens to cause infections in catheterized patients. Nitric oxide (NO) is a naturally-produced gas molecule with broad-spectrum antimicrobial activity. NO is used in the clinics to treat pulmonary hypertension in neonates and adults. Studies have shown that low-dose NO is associated with prevention of biofilm formation, biofilm dispersal and elimination of bacteria. It is suggested that NO prevents bacteria attachment to catheter surfaces and inhibits biofilm formation in a mechanism involving reduction and modification of proteins that mediate cell-substrate and cell-cell interactions. The investigators team, using a proprietary technology impregnate urinary catheters with NO (i.e. NO-impregnated catheters). These catheters release low concentration of NO following exposure to urine over a 14-day period. In vitro studies showed that NO-impregnated catheters prevent bacterial colonization and biofilm formation of Escherichia coli on exterior and luminal surfaces of the catheters. In addition, NO released from these catheters is able to eradicate up to 4log colony forming unit/ml of bacteria within the surrounding media. Moreover, NO-impregnated catheters exhibit superior performance compared to silver-coated catheters, and similar anti-infective properties compared to antibiotic-coated catheters. Primary objectives: To assess the safety and tolerability of NO-impregnated catheters in patients older than 18 years old undergoing radical prostatectomy and catheterized for 7-14 days.","other_id":"ENOX PHASE I_1.1","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patients before radical prostatectomy at the Department of Urology in Beilinson\r\n             Medical Center, which will be catheterized for 7-14 days.\r\n\r\n          2. Age:  18 years.\r\n\r\n          3. Patients with a life expectancy of more than 12 months.\r\n\r\n          4. The investigator has completed a medical history and a physical examination to assure\r\n             that the patients meets all study enrollment criteria.\r\n\r\n          5. The patient is willing and able to read, understand and sign the study specific\r\n             informed consent form.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. A urinary culture demonstrating UTI before surgery.\r\n\r\n          2. A patient with an indwelling urinary catheter prior to surgery.\r\n\r\n          3. Expected life expectancy of less than 12 months.\r\n\r\n          4. Concurrent illness, disability or geographical residence that would hamper study\r\n             participation.\r\n\r\n          5. Patients with underlying diseases such as heart disease, lung disease, skin disease or\r\n             infection involving the penis, scrotum and groin, immunocompromised patients\r\n             (transplant recipients, HIV carriers) or any other disease or condition that according\r\n             to the physician opinion will influence the study results.\r\n\r\n          6. Patients with known urethral stricture.\r\n\r\n          7. Patients with recurrent UTIs.\r\n\r\n          8. Current participation in another clinical investigation of a medical device or a drug\r\n             or has participated in such a study within 30 days prior to study enrollment.\r\n      ","sponsor":"Enox Israel Ltd","sponsor_type":"Industry","conditions":"Urinary Tract Infection|Bacteriuria","interventions":[{"intervention_type":"Device","name":"Device: Nitric Oxide impregnated catheter","description":"Patients undergoing radical prostatectomy will be catheterized for 7-14 days with Nitric Oxide impregnated Foley catheters"}],"outcomes":[{"outcome_type":"primary","measure":"Number of participants with adverse events associated with Nitric Oxide impregnated catheters","time_frame":"30-45 days"},{"outcome_type":"primary","measure":"Proportion of patients (%) who prematurely discontinued the study due to adverse events or severe adverse events associated with Nitric oxide impregnated catheters","time_frame":"30-45 days"},{"outcome_type":"secondary","measure":"Measuring biofilm forming bacteria on the surface of Nitric Oxide impregnated and non impregnated Foley catheters after indwelling for 7 to 14 days","time_frame":"7-14 days"},{"outcome_type":"secondary","measure":"Measuring bacteriuria (by urine culture) for Nitric Oxide impregnated and non impregnated Foley catheters prior to insertion, 1 day after insertion, every day during hospitalization, on catheter removal day, and 30 days after catheterization","time_frame":"30-45 days"},{"outcome_type":"secondary","measure":"Measuring number of urinary tract infection (UTI) events following catheterization with Nitric Oxide impregnated and non impregnated Foley catheters","time_frame":"30-45 days"},{"outcome_type":"secondary","measure":"Proportion of patients (%) who prematurely discontinued the study for any reason","time_frame":"30-45 days"}]}
{"nct_id":"NCT02813317","start_date":"2014-12-31","enrollment":617,"brief_title":"Optimizing the Care Pathways of Patients Treated for Operable Breast.","official_title":"Optimizing the Care Pathways of Patients Treated for Operable Breast Cancer","primary_completion_date":"2017-02-28","study_type":"Observational","rec_status":"Completed","completion_date":"2017-04-30","last_update":"2017-04-13","description":"This prospective, multicenter, observational study aims to explore a comprehensive approach to the care of early breast cancer patients in a regional health territory (including 1.5 million women and characterized by a breast cancer incidence and mortality higher than national ranges), incorporating all healthcare actors inside and outside the hospital.","other_id":"IC 2014-11","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"Female","minimum_age":18,"population":"Previously untreated, operable breast cancer.","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Signed written informed consent.\r\n\r\n          2. Patients aged 18 years.\r\n\r\n          3. Previously untreated, operable breast cancer\r\n\r\n          4. Affiliation with the social security system (or a similar coverage)\r\n\r\n          5. Patient living in one of these french department : \"Hauts-de-Seine (92)\", \"les\r\n             Yvelines (78)\", or \"le Val d'Oise (95)\".\r\n\r\n          6. Female gender.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Previous history of breast cancer.\r\n\r\n          2. Metastatic, locally advanced, or inflammatory breast cancer, as defined by the AJCC\r\n             (American Joint Committee on Cancer, 7th Edition).\r\n\r\n          3. Any prior treatment for primary breast cancer.\r\n\r\n          4. Patient with any psychological, sociological or geographical condition potentially\r\n             hampering compliance with the study follow-up schedule.\r\n      ","sponsor":"Institut Curie","sponsor_type":"Other","conditions":"Breast Cancer|Surgery","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Overall cost measurements of the different care pathways for health insurance","time_frame":"Up to one year after patient registration","description":"Evaluating the indirect costs of health insurance"},{"outcome_type":"primary","measure":"Care pathways description of early breast cancer patients.","time_frame":"Up to one year after patient registration","description":"Care pathways will be characterized by the sequence of different care steps. Care steps may include : outpatient surgery, home hospitalization, a one-stop breast clinic visit, care by an oncology pivot nurse and/or screening for supportive care."},{"outcome_type":"primary","measure":"Overall cost measurements of the different care pathways.","time_frame":"Up to one year after patient registration","description":"Evaluating the overall costs of the pathway care (health care and supportive care consumption) at one year for the different perspectives."},{"outcome_type":"primary","measure":"Overall cost measurements of the different care pathways for the patient","time_frame":"Up to one year after patient registration","description":"Evaluating the out-of-pocket health expenses for breast cancer during the first year post diagnosis (direct and indirect costs)."},{"outcome_type":"secondary","measure":"Patient satisfaction evaluation","time_frame":"Up to one year after patient registration.","description":"Patient satisfaction will be assessed at different time points using the OUT-PATSAT35 questionnaire validated in French."},{"outcome_type":"secondary","measure":"Supportive care needs assessement","time_frame":"Up to one year after patient registration","description":"The patient's needs for supportive care will be assessed using the Supportive Care Needs Survey - Breast Cancer module (SCNS-BR8) validated in French."},{"outcome_type":"secondary","measure":"Supportive care needs assessement","time_frame":"Up to one year after patient registration","description":"The patient's needs for supportive care will be assessed using the Supportive Care Needs Survey Short Form (SCNS-SF34) validated in French."},{"outcome_type":"secondary","measure":"Breast cancer impact on patient's professional activity","time_frame":"Up to one year after patient registration.","description":"Evaluating patient return to work : Existence of an occupational reintegration or not."},{"outcome_type":"secondary","measure":"Breast cancer impact on patient's professional activity","time_frame":"Up to one year after patient registration.","description":"Evaluating patient return to work : Date of return to work"},{"outcome_type":"secondary","measure":"Breast cancer impact on patient's professional activity","time_frame":"Up to one year after patient registration.","description":"Evaluating patient return to work : Organization of working time description"},{"outcome_type":"secondary","measure":"Breast cancer impact on patient's professional activity","time_frame":"Up to one year after patient registration.","description":"Evaluating patient return to work : Number of days out of work"},{"outcome_type":"secondary","measure":"Structures and organizations interactions description","time_frame":"Up to one year after patient registration","description":"Identification of health care actors inside and outside the hospital"},{"outcome_type":"secondary","measure":"Structures and organizations interactions description","time_frame":"Up to one year after patient registration","description":"identification of the interactions between the organizations (e.g., identification, shared tools, resource sharing and nurse training)."},{"outcome_type":"secondary","measure":"Structures and organizations interactions description","time_frame":"Up to one year after patient registration","description":"Regular practitioners questionnaires"},{"outcome_type":"other","measure":"Care pathways suggestion for a regional health territory.","time_frame":"Through study completion (within one year after the last patient follow-up)","description":"After analyzing these care pathways, we will propose solutions for optimizing hospital and nonhospital care, thereby building efficient connections among the hospital, home health care, district nurse networks, medical and social sectors, and occupational reintegration."}]}
{"nct_id":"NCT02282215","start_date":"2014-12-31","phase":"Phase 2","enrollment":163,"brief_title":"Safety and Efficacy of Human Myeloid Progenitor Cells (CLT-008) During Chemotherapy for Acute Myeloid Leukemia","official_title":"An Open-Label Phase 2 Prospective, Randomized, Controlled Study of CLT-008 Myeloid Progenitor Cells as a Supportive Care Measure During Induction Chemotherapy for Acute Myeloid Leukemia","primary_completion_date":"2017-09-22","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-09-22","last_update":"2018-09-27","description":"The purpose of the study is to explore the safety and efficacy of CLT-008 as an extra supportive care measure after induction chemotherapy for patients with acute myeloid leukemia (AML).","other_id":"CLT008-03","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Acute myeloid leukemia arising de novo (per European LeukemiaNet)\r\n\r\n          2. Treated with any established chemotherapy regimen based on either:\r\n\r\n               1. 7+3: Standard-dose cytarabine 100-200 mg per meter squared continuous infusion\r\n                  for 7 days with idarubicin 12 mg per meter squared or daunorubicin 45-90 mg per\r\n                  meter squared for 3 days\r\n\r\n               2. High-dose cytarabine-based (HIDAC) chemotherapy administering a total cytarabine\r\n                  dose of  4 g per meter squared alone or in combination with other anti-leukemic\r\n                  agents (for example, anthracyclines, purine nucleoside inhibitors, etoposide,\r\n                  etc.)\r\n\r\n          3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at Screening or by\r\n             the day chemotherapy is initiated\r\n\r\n          4. Adequate respiratory function with a room air oxygen saturation of at least 92%\r\n\r\n          5. Adequate cardiac function defined as an ejection fraction of at least 45%\r\n\r\n          6. Serum bilirubin  1.5 times the upper limits of normal. Subjects with a history of\r\n             Gilbert's syndrome may be enrolled if the total bilirubin is < 3 mg/dL with an\r\n             indirect bilirubin of > 1.5 mg/dL\r\n\r\n          7. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST)  2.5 times\r\n             upper limits of normal prior to chemotherapy\r\n\r\n          8. Serum creatinine  2 times upper limits of normal or estimated glomerular filtration\r\n             rate  60 mL/min/1.73 meter squared per Modification of Diet in Renal Disease equation\r\n             (MDRD)\r\n\r\n          9. All subjects, except post-menopausal women, must be willing to utilize a highly\r\n             effective method of contraception throughout the study\r\n\r\n         10. Adequately informed of the nature and risks of the study with written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Pregnant or breast feeding\r\n\r\n          2. Overt central nervous system manifestations of leukemia at diagnosis\r\n\r\n          3. Specifically diagnosed and uncontrolled fungal, bacterial, viral, or other infection\r\n             (e.g. confirmed sepsis, pneumonia, abscess, cellulitis, etc.) at the day chemotherapy\r\n             is initiated. \"Uncontrolled\" is defined as exhibiting ongoing signs and symptoms of\r\n             infection without improvement despite antimicrobial or other treatment.\r\n\r\n          4. AML subtype M3 (promyelocytic leukemia)\r\n\r\n          5. Previous chemotherapy for AML\r\n\r\n          6. History of or current human immunodeficiency virus (HIV) or hepatitis C virus\r\n             infection\r\n\r\n          7. History of or current clinically significant immunodeficiency\r\n\r\n          8. Known contraindication to receiving G-CSF\r\n\r\n          9. History of or current clinically significant alloimmunization to leukocyte antigens\r\n\r\n         10. Participation in another clinical study within 28 days of the day chemotherapy is\r\n             initiated, in which the study drug or device may influence hematopoiesis.\r\n             Co-enrollment in another study is allowed in cases where the investigational therapy\r\n             under study is a version of an acceptable chemotherapy regimen for this study per the\r\n             inclusion criteria.\r\n\r\n         11. Receiving any agent concurrently with CLT-008 infusion which inhibits cell division\r\n             (e.g., methotrexate or hydroxyurea)\r\n\r\n         12. Acute or chronic medical disorder that, in the opinion of the investigator or medical\r\n             monitor, may prevent the subject from completing participation in the study\r\n      ","sponsor":"Cellerant Therapeutics","sponsor_type":"Industry","conditions":"Acute Myeloid Leukemia|Neutropenia|Infection","interventions":[{"intervention_type":"Biological","name":"Biological: CLT-008","description":"Single intravenous infusion"},{"intervention_type":"Biological","name":"Biological: G-CSF","description":"Daily subcutaneous injections"}],"outcomes":[{"outcome_type":"primary","measure":"Duration of febrile episodes (fever)","time_frame":"42 days"},{"outcome_type":"secondary","measure":"Time to absolute neutrophil count (ANC) recovery","time_frame":"42 days"},{"outcome_type":"secondary","measure":"Incidence and duration of febrile neutropenia","time_frame":"42 days"},{"outcome_type":"secondary","measure":"Incidence and duration of infection","time_frame":"42 days"},{"outcome_type":"secondary","measure":"Incidence and severity of mucositis","time_frame":"42 days"},{"outcome_type":"secondary","measure":"Incidence of infusion reactions","time_frame":"42 days"},{"outcome_type":"secondary","measure":"Incidence of Graft-versus-Host Disease (GVHD)","time_frame":"42 days"},{"outcome_type":"secondary","measure":"Incidence of Adverse Events (AE)","time_frame":"42 days"},{"outcome_type":"secondary","measure":"Incidence of Serious Adverse Events (SAE)","time_frame":"42 days"}]}
{"nct_id":"NCT02137408","start_date":"2014-12-31","phase":"N/A","enrollment":0,"brief_title":"Docosahexaenoic Acid Supplementation of Women With Hypertension in Pregnancy to Improve Endothelial Health","official_title":"Docosahexaenoic Acid Supplementation of Women With Hypertension in Pregnancy to Improve Endothelial Health and Reduce the Risks of Preterm Delivery","primary_completion_date":"2015-11-30","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2016-04-30","last_update":"2014-09-18","description":"The Investigator would like to see if taking a DHA supplement at a dose recommended for heart health will improve brachial artery dilation (relaxation) and help blood pressure. As a second goal the Investigator would like to see if this supplement can delay preterm delivery by improving heart health. In this research study, the Investigator is asking pregnant women with chronic high blood pressure to take Expecta (DHA - Martek Biosciences, now known as DSM Nutritional Lipil) during the last half of their pregnancy until six weeks after they deliver their baby.","other_id":"2013-7329","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Pregnant women coming for their 19-20 week ultrasound for fetal anatomy and that have\r\n             been diagnosed with hypertension by their Obstetrician will be eligible for inclusion.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Exclusions to enrollment will include: women < 18 years old\r\n\r\n          -  Bleeding disorders\r\n\r\n          -  Lupus\r\n\r\n          -  Autoimmune diseases\r\n\r\n          -  The presence of infant congenital (trisomy 13,18, 21, urethral, gastrointestinal and\r\n             cardiac defects)\r\n      ","sponsor":"Children's Hospital Medical Center, Cincinnati","sponsor_type":"Other","conditions":"Hypertension in Pregnancy","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Docosahexaenoic acid 200 mg","description":"Participants will be randomized to 200 mg docosahexaenoic acid daily (1-200mg capsule) PO beginning at 18-20 weeks gestation through 6 weeks post-partum."},{"intervention_type":"Drug","name":"Drug: Docosahexaenoic acid 1000 mg","description":"Participants will be randomized to 1000 mg (5-200mg capsules) docosahexaenoic acid PO daily beginning at 18-20 weeks gestation through 6 weeks post-partum."}],"outcomes":[{"outcome_type":"primary","measure":"Improve maternal endothelial health","time_frame":"Pregnant mothers 18-20 weeks gestation (Baseline) - Six weeks post partum","description":"To test this hypothesis, the Investigator will undertake a RCT of 90 women with hypertension (chronic or newly diagnosed) in the second trimester of pregnancy, who will be randomized to 1000mg DHA or standard supplement and followed through to delivery with serial measures of blood pressure and vascular constriction by the Doppler method."},{"outcome_type":"secondary","measure":"Improve immune homeostasis","time_frame":"Pregnant mothers 18-20 weeks gestation (Baseline) through 6 weeks post partum","description":"Measured by decreased maternal blood and cord blood concentrations of pro-inflammatory cytokines IL-6, I L-8, TNF a, and receptor sRAGE."},{"outcome_type":"other","measure":"Decrease the number of infants born <34 weeks","time_frame":"Pregnant mothers 18-20 weeks gestation (Baseline) through 6 weeks post partum","description":"In addition to the primary aims, we will examine evidence that DHA will prolong gestation"}]}
{"nct_id":"NCT02754154","start_date":"2014-12-31","enrollment":88983,"brief_title":"Real-World Comparative Observational Study in Non-Valvular Atrial Fibrillation Patients Using Oral Anticoagulants","official_title":"Real-World Comparative Observational Study in Non-Valvular Atrial Fibrillation Patients Using Oral Anticoagulants","primary_completion_date":"2018-12-26","study_type":"Observational","rec_status":"Unknown status","completion_date":"2019-02-26","last_update":"2018-04-11","description":"The purpose of this study is to compare the risk of major bleeding event among nonvalvular atrial fibrillation patients treated with warfarin, apixaban, dabigatran and rivaroxaban.","other_id":"CV185-433","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using oral\r\n        anticoagulants","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients 18 years old as of the index date\r\n\r\n          -  At least 1 diagnosis of atrial fibrillation in the 12 months prior to or on index\r\n             date, identified by any medical claim\r\n\r\n          -  At least one year of baseline period and continuous enrollment for at least 12 months\r\n             prior to index date Individuals with NVAF who were using oral anticoagulants (i.e.,\r\n             warfarin, dabigatran, rivaroxaban and apixaban) within the study period beginning Jan\r\n             1, 2012 through December 31, 2013 or last date of the last data cut available at the\r\n             time of execution of the study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with evidence of valvular heart disease, thyrotoxicosis, pericarditis, mitral\r\n             stenosis, Venous thromboembolism(VTE), heart surgery, and endocarditis during the\r\n             baseline period any time prior to or on index date\r\n\r\n          -  Patients with any evidence of pregnancy at any time during the baseline will be\r\n             excluded\r\n      ","sponsor":"Bristol-Myers Squibb","sponsor_type":"Industry","conditions":"Atrial Fibrillation","interventions":[{"intervention_type":"Drug","name":"Drug: Warfarin"},{"intervention_type":"Drug","name":"Drug: Apixaban"},{"intervention_type":"Drug","name":"Drug: Dabigatran"},{"intervention_type":"Drug","name":"Drug: Rivaroxaban"}],"outcomes":[{"outcome_type":"primary","measure":"Time to \"First Major\" Bleeding event","time_frame":"Up to 25 months"},{"outcome_type":"secondary","measure":"Time to \"First Any\" Bleeding event","time_frame":"Up to 25 months"},{"outcome_type":"secondary","measure":"Major Bleeding-Related Healthcare Utilization","time_frame":"Up to 25 months","description":"(Number of Hospitalizations, Total Length of Hospital Stay (days), Time to Hospitalization, Number Of Emergency Room (ER) visits, and Number of Outpatient Visits with at least 1 major bleeding event )"},{"outcome_type":"secondary","measure":"Any Bleeding-Related Healthcare Utilization","time_frame":"Up to 25 months","description":"(Number of Hospitalizations, Total Length of Hospital Stay (days), Time to Hospitalization, Number Of Emergency Room (ER) visits, and Number of Outpatient Visits with at least 1 bleeding event )"},{"outcome_type":"secondary","measure":"Major Bleeding-Related direct medical cost","time_frame":"Up to 25 months","description":"(Inpatient costs, Outpatient costs, and Emergency Room (ER) costs related to at least 1 major bleeding event)"},{"outcome_type":"secondary","measure":"Any Bleeding-Related direct medical cost","time_frame":"Up to 25 months","description":"(Inpatient costs, Outpatient costs, and Emergency Room (ER) costs related to at least 1 bleeding event)"}]}
{"nct_id":"NCT02473029","start_date":"2014-12-31","enrollment":45,"brief_title":"Interest of Medical Imaging in the Diagnostic Strategy Vis a Vis a Suspected Horton Disease","primary_completion_date":"2018-06-30","study_type":"Observational","rec_status":"Terminated","completion_date":"2018-06-30","last_update":"2018-12-19","description":"The study aims at measuring the sensitivity and specificity of a series of imaging signs (recorded by magnetic resonance angiography, vascular tomodensitometry, vascular ultrasonography, retina angiography and retina optic coherence tomography) for the diagnosis of Horton disease, the gold standard being the result of temporal artery biopsy.","other_id":"GEL_2014_01","observational_model":"Case-Only","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients admitted to the Fondation Ophtalmologique Adolphe de Rothschild with a suspected\r\n        Horton disease","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients admitted to the Fondation Ophtalmologique Adolphe de Rothschild and suspected\r\n             to suffer from Horton disease, based on the presence of 3 or more major criteria, or 2\r\n             major criteria and at least one minor criteria.\r\n\r\n        Major criteria : Age > 50 ans ; headache ; intermittent jaw or tongue pain ; visual\r\n        impairment ; ESR > 50 mm at 1h and/or CRP > 8mg/l.\r\n\r\n        Minor criteria: temporal artery or scalp tenderness ; facial pain or tenderness ; fever\r\n        >38C, weight loss >10%, anorexia, fatigue.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Autoimmune disease\r\n\r\n          -  Active infectious condition\r\n\r\n          -  Malignant disease\r\n\r\n          -  Condition counterindicating one or several of the protocol's imaging procedures :\r\n             allergy to iodine and/or renal insufficiency and/or claustrophobia and/or metallic\r\n             foreign body...\r\n      ","sponsor":"Fondation Ophtalmologique Adolphe de Rothschild","sponsor_type":"Other","conditions":"Horton Disease","interventions":[{"intervention_type":"Radiation","name":"Radiation: Vascular tomodensitometry"},{"intervention_type":"Other","name":"Other: Magnetic resonance angiography"},{"intervention_type":"Other","name":"Other: Vascular ultrasonography"},{"intervention_type":"Other","name":"Other: Retinal angiography"},{"intervention_type":"Other","name":"Other: Retinal optical coherence tomography"}],"outcomes":[{"outcome_type":"primary","measure":"MRI angiography mural inflammation","time_frame":"Baseline","description":"Presence of signs of artery mural inflammation in T1 sequence of MRI angiography"}]}
{"nct_id":"NCT02404844","start_date":"2014-12-31","phase":"Phase 2","enrollment":48,"brief_title":"Trial of BKM120/Tamoxifen-combination in Patients With HR-pos, HER2-neg Breast Cancer","official_title":"Molecularly Stratified Parallel Cohort, Single Arm Phase II Trial of the Phosphoinositide 3-kinase (PI3K) Inhibitor Buparlisib (BKM120) in Combination With Tamoxifen in Patients With Hormone Receptor-positive, HER2-negative Inoperable (Locally Advanced or Metastatic) Breast Cancer With Prior Exposure to Antihormonal Therapy","primary_completion_date":"2017-09-19","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-10-19","last_update":"2018-04-20","description":"This is a clinical trial with a molecularly stratified parallel cohort, single arm design to explore the efficacy and safety of BKM120 in combination with tamoxifen in patients with ER/PR-positive, HER2-negative breast cancer with prior exposure to antihormonal therapy, and different biomarker profiles, two of them potentially indicative of constitutive PI3K pathway activation.","other_id":"iOM-02282","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patient has histologically and/or cytologically confirmed diagnosis of breast cancer\r\n\r\n          -  Patient has radiologic or objective evidence of inoperable locally advanced, or\r\n             metastatic breast cancer\r\n\r\n          -  Patient has a known hormone receptor status HR-positive (ER and/or PR positive) and\r\n             HER2-negative status\r\n\r\n          -  Patient has a representative archival formalin-fixed tumor biopsy (metastasis or\r\n             primary tumor)\r\n\r\n          -  Patient has prior exposure to antihormonal therapy\r\n\r\n          -  Patient has received  2 prior antihormonal treatments in the metastatic setting\r\n\r\n          -  Prior treatment with tamoxifen in the (neo-)adjuvant setting is allowed but has to be\r\n             discontinued for at least 1 year.\r\n\r\n          -  Patient may have received up to one prior chemotherapy in the metastatic setting\r\n\r\n          -  Measurable or non-measurable lesions according to RECIST v1.1 criteria\r\n\r\n          -  Patient has an Eastern Cooperative Oncology Group (ECOG) performance status score  2\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patient has received previous treatment with a PI3K- or AKT-inhibitor or\r\n             mTOR-inhibitors\r\n\r\n          -  Prior treatment with Tamoxifen in the metastatic setting. Treatment with tamoxifen in\r\n             the (neo-)adjuvant setting is allowed, but has to be discontinued for at least 1 year\r\n\r\n          -  Patient has symptomatic CNS metastases\r\n\r\n          -  Patient has a medically documented history of or active major depressive episode,\r\n             bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of\r\n             suicidal attempt or ideation, or homicidal ideation (e.g. risk of doing harm to self\r\n             or others), or patients with active severe personality disorders (defined according to\r\n             DSM-IV).\r\n\r\n          -  Patient has a known history of HIV infection (testing not mandatory) infection\r\n      ","sponsor":"University Hospital, Essen","sponsor_type":"Other","conditions":"Breast Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: BKM120","description":"daily oral"},{"intervention_type":"Drug","name":"Drug: Tamoxifen","description":"daily oral"}],"outcomes":[{"outcome_type":"primary","measure":"Progression free survival (PFS)-rate in the full population, after 6 months","time_frame":"6 months","description":"PFS is defined as time from date of start of treatment to the date of the event, defined as the first documented disease progression or death due to any cause per local investigator assessment"},{"outcome_type":"secondary","measure":"Progression free survival (PFS)- rate in the subpopulations after 6 months of combination therapy","time_frame":"6 months","description":"PFS is defined as time from date of start of treatment to the date of the event, defined as the first documented disease progression or death due to any cause per local investigator assessment"},{"outcome_type":"secondary","measure":"Progression-free survival (PFS)","time_frame":"6 months","description":"PFS in subpopulations and full population. PFS is defined as time from date of start of treatment to the date of the event, defined as the first documented disease progression or death due to any cause per local investigator assessment"},{"outcome_type":"secondary","measure":"1 year overall survival (OS) rate","time_frame":"1 year","description":"OS is defined as time from date of start of treatment to the date of death from any cause."},{"outcome_type":"secondary","measure":"2 years overall survival (OS) rate","time_frame":"2 years","description":"OS is defined as time from date of start of treatment to the date of death from any cause."},{"outcome_type":"secondary","measure":"Overall response rate (ORR)","time_frame":"6 months","description":"ORR is defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) (RECIST v1.1)."},{"outcome_type":"secondary","measure":"Disease control rate (DCR)","time_frame":"6 months","description":"DCR is defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) or stable disease (SD) lasting more than 12 weeks (RECIST v1.1)."},{"outcome_type":"secondary","measure":"Number of Participants with Adverse Events as a Measure of Safety and Tolerability","time_frame":"From date of informed consent to +30 days from last application of study medication","description":"Type, frequency and severity of adverse events per CTCAE v4.03"},{"outcome_type":"secondary","measure":"Incidence and severity of depressive episodes during the course of treatment","time_frame":"From date of informed consent to +30 days from last application of study medication","description":"Change in depressive episodes assessed by PHQ-9 questionnaire"},{"outcome_type":"secondary","measure":"Incidence and severity of depressive episodes during the course of treatment","time_frame":"From date of informed consent to +30 days from last application of study medication","description":"Change in depressive episodes assessed by GAD-7 questionnaire"},{"outcome_type":"other","measure":"Identification of genomic signatures associated with clinical outcome in response to PI3K pathway-directed therapy with tamoxifen and buparlisib in ER/PR-positive breast cancer.","time_frame":"2 years","description":"Finding of genomic signatures associated with clinical outcome in response to PI3K pathway-directed therapy with tamoxifen and buparlisib in ER/PR-positive breast cancer."},{"outcome_type":"other","measure":"Validation of a proprietary technology for highly sensitive and specific mutation detection of circulating free tumor DNA","time_frame":"2 years","description":"Finding of specific mutation detection of circulating free tumor DNA"}]}
{"nct_id":"NCT02200172","start_date":"2014-12-31","phase":"Phase 2","enrollment":60,"brief_title":"The Preventative Role of Exogenous Melatonin Administration in Patients With Advanced Cancer Who Are at Risk of Delirium: a Feasibility Study","official_title":"The Preventative Role of Exogenous Melatonin Administration in Patients With Advanced Cancer Who Are at Risk of Delirium: a Feasibility Study Prior to a Larger Randomized Controlled Trial","primary_completion_date":"2016-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-04-30","last_update":"2016-07-19","description":"The purpose of this feasibility study is to inform a larger randomized, placebo-controlled, double blind, parallel-group, single-centre trial of an oral, daily administered single dose of melatonin to prevent delirium in patients with advanced cancer.","other_id":"BRI-MELAT-2013","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Males and females  18 years\r\n\r\n          -  Cancer diagnosis\r\n\r\n          -  Admitted to Palliative Care Unit\r\n\r\n          -  English speaking\r\n\r\n          -  Cognitive capacity to give informed consent or substitute decision maker is accessible\r\n             to provide consent\r\n\r\n          -  Palliative Performance Scale  30% at the time of consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Delirium present on admission (assessed clinically with the CAM)\r\n\r\n          -  Known psychotic disorder other than dementia\r\n\r\n          -  Inability to take medications sublingually or via gastrostomy tube\r\n\r\n          -  Known allergy to melatonin or placebo content\r\n\r\n          -  Use of melatonin within the two weeks preceding admission\r\n\r\n          -  Patient on warfarin treatment or other oral anticoagulant\r\n\r\n          -  Communication problems that cannot be accommodated, including deafness, tracheostomy,\r\n             aphasia, dysarthria or emotional distress\r\n\r\n          -  On other investigational agents or treatments\r\n\r\n          -  Pregnancy or lactation\r\n\r\n          -  Severe visual impairment or designated legally blind\r\n\r\n          -  Immunosuppressant medication use in the context of autoimmune disease or post organ\r\n             transplantation\r\n      ","sponsor":"Bruyere Research Institute","sponsor_type":"Other","conditions":"Cancer","interventions":[{"intervention_type":"Other","name":"Other: Melatonin","description":"Sublingual 3mg non-animal synthetic source melatonin daily at 21.00 hours (1 hour)."},{"intervention_type":"Other","name":"Other: Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"Time to first onset of delirium for participants receiving active comparator versus placebo","time_frame":"8 months","description":"Preliminary data will help determine the appropriateness of this outcome measure in a larger trial."},{"outcome_type":"primary","measure":"Number of times the blinding on the trial product is broken.","time_frame":"8 months","description":"This number will indicate any further need for research team training."},{"outcome_type":"primary","measure":"Recruitment and retention rates","time_frame":"8 months","description":"Recruitment and retention rates will determine if a larger trial with the same design will allow for a sufficient number of participants."},{"outcome_type":"primary","measure":"Frequency of protocol violation","time_frame":"8 months","description":"The frequency of protocol violations will indicate if a larger trial with the same design can be implemented in a palliative care setting or require modification."},{"outcome_type":"primary","measure":"Number of unsolicited positive versus negative comments from participants, families, and Palliative Care Unit staff","time_frame":"8 months","description":"Comments that are voluntarily provided will show whether the trial is acceptable to participants, families, Palliative Care Unit staff."},{"outcome_type":"secondary","measure":"Predisposing and precipitating risks form completion rate","time_frame":"8 months","description":"Predisposing and precipitating factors will be collected on trial forms throughout the trial. The feasibility of collecting this data on the Palliative Care Unit will be measured by form completion rates."},{"outcome_type":"secondary","measure":"Number of participants with serious adverse events related to the active comparator","time_frame":"Participants will be followed for the duration of trial product administration plus 2 days for an expected total of 30 days","description":"To assess the safety of the proposed intervention in this palliative care population will be assessed on an ongoing basis."}]}
{"nct_id":"NCT02328001","start_date":"2014-12-31","phase":"N/A","enrollment":969,"brief_title":"Cost-Minimization Analysis After a Targeted Intervention for EGD and Colonoscopy","official_title":"Cost-Minimization Analysis and Its Impact on Resource Utilization After a Targeted Intervention for EGD and Colonoscopy","primary_completion_date":"2015-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-10-31","last_update":"2017-04-07","description":"This study performs a single intervention of informing endoscopists how much the disposable accessories cost following each procedure. Following this single and simple intervention, prospective analysis of EGD and colonoscopy accessory use and pathology specimen costs will be compared to the same resource costs during a control period where endoscopists are blinded to their observation.","other_id":"4667","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Other","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adults with age of 18 or greater\r\n\r\n          -  All races\r\n\r\n          -  Indication for therapeutic EGD or colonoscopy\r\n\r\n          -  Outpatient procedures done at OU Physicians Building endoscopy unit\r\n\r\n          -  Procedure is performed by one of the observed endoscopists\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pediatric population\r\n\r\n          -  Diagnostic EGD and colonoscopy procedures\r\n      ","sponsor":"Sindhu R Kaitha, MD","sponsor_type":"Other","conditions":"Primary Focus of the Study is Cost-minimization Analysis","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Debriefing endoscopists of the procedure accessory costs","description":"Informing endoscopists of the number of accessories used and the dollar value of the accessories"}],"outcomes":[{"outcome_type":"primary","measure":"Total cost of accessory use and pathology specimen costs","time_frame":"Up to 5 months","description":"The cost of accessory and pathology specimens would be assessed immediately post-procedure during phase 2"}]}
{"nct_id":"NCT02367599","start_date":"2014-12-15","phase":"Phase 4","enrollment":48,"brief_title":"Effect of Vitamin D Supplementation on Bone Turnover Markers During PrEP in MSM","official_title":"Effect of Vitamin D Supplementation on Bone Turnover Markers During Tenofovir-Emtricitibine Pre-Exposure Prophylaxis in Men Who Have Sex With Men; A Sub-study of CCTG 595","primary_completion_date":"2018-06-13","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-07-11","last_update":"2020-07-02","description":"CCTG 595 is an open-label clinical trial of the effect of a text messaging intervention vs. standard of care on adherence to Truvada as PrEP in MSM at increased risk for HIV infection (ClinicalTrials.gov Identifier: NCT01761643). Eligible subjects for this matched case control substudy will receive vitamin D 4000 IU/day for 24 weeks, from week 24 through week 48. In CCTG 595, plasma from participants are being collected and stored at entry and every 12 weeks. These plasma samples will be used to measure P1NP, CTX, PTH, and vitamin D levels in both cases and controls at entry, week 24, and week 48.","other_id":"CCTG 595 Vitamin D Sub-Study","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  All subjects must meet CCTG 595 inclusion criteria.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  All subjects must meet CCTG 595 exclusion criteria.\r\n\r\n          -  Current or prior use of bisphosphonate therapy.\r\n\r\n          -  Current use of Vitamin D supplements greater than 400 IU/day.\r\n\r\n          -  Current use of androgenic hormones or growth hormones.\r\n\r\n          -  History of nephrolithiasis (kidney stones).\r\n\r\n          -  History of fragility fracture.\r\n\r\n          -  No use of tenofovir prior to entry into CCTG 595\r\n      ","sponsor":"University of California, San Diego","sponsor_type":"Other","conditions":"Patient Adherence","interventions":[{"intervention_type":"Drug","name":"Drug: Vitamin D Supplement","description":"Subjects enrolled into this sub-study will be provided Vitamin D 4000IU/day for 24 Weeks."}],"outcomes":[{"outcome_type":"primary","measure":"Change in Total Procollagen Type 1 N-terminal Propeptide (a Marker of Bone Formation) [P1NP] Levels","time_frame":"Weeks 24-48","description":"To compare the change in P1NP levels from Week 24 through Week 48 among subjects (cases) who receive vitamin D 4000 IU/day to the change in levels seen in matched unsupplemented controls"},{"outcome_type":"secondary","measure":"Change in CTX-1 Levels","time_frame":"Weeks 24-48","description":"To compare the change in CTX-1 levels from Week 24 through Week 48 among subjects (cases) who receive vitamin D 4000 IU/day to the change in levels seen in matched unsupplemented controls"},{"outcome_type":"secondary","measure":"Change in PTH Levels","time_frame":"Weeks 24-48","description":"To compare the change in PTH levels from Week 24 through Week 48 among subjects (cases) who receive vitamin D 4000 IU/day to the change in levels seen in matched unsupplemented controls"},{"outcome_type":"secondary","measure":"Change in 25-OH Vitamin D3 Levels","time_frame":"Weeks 24-48","description":"To compare the change in 25-OH vitamin D3 levels from Week 24 through Week 48 among subjects (cases) who receive vitamin D 4000 IU/day to the change in levels seen in matched unsupplemented controls"}]}
{"nct_id":"NCT02282059","start_date":"2014-12-12","enrollment":100,"brief_title":"The Safety And Efficacy Of Sunitinib In Chinese Patients With Progressive Advanced Or Metastatic Well-Differentiated Unresectable Pancreatic Neuroendocrine Tumors","official_title":"A MULTI-CENTER, PROSPECTIVE, NON-INTERVENTIONAL (NI) STUDY OF THE SAFETY AND EFFICACY OF SUNITINIB IN CHINESE PATIENTS WITH PROGRESSIVE ADVANCED OR METASTATIC WELL-DIFFERENTIATED UNRESECTABLE PANCREATIC NEUROENDOCRINE TUMORS","primary_completion_date":"2022-12-12","study_type":"Observational","rec_status":"Recruiting","completion_date":"2022-12-12","last_update":"2021-09-01","description":"This study is a multi-center, prospective, non-interventional (NI) study evaluating the safety and efficacy of sunitinib in Chinese patients with progressive, unresectable, advanced or metastatic well-differentiated, pancreatic neuroendocrine tumors(pNET). 100 adults with progressive advanced or metastatic well-differentiated unresectable pNET will be recruited in China hospitals. Each subject will be followed up overall survival (OS) time or the date of withdrawal and subjects who remain alive after study completion will have their OS time censored on the last date known to be alive. Eligible subjects will be enrolled to receive at least one dose of sunitinib orally at 37.5 mg once a day on a continuous daily dosing regimen (CDD) or dosage modification is based on daily clinic practice. Subjects will be treated until disease progress, unacceptable toxicity, withdrawal from the study at their own request, or until the final analysis for the study is performed. The NI study will capture observations that will be used for evaluating the safety profile of sunitinib, including: subject demographics, medical history and medications. Safety assessments, treatment data and any other laboratory examination results, which were done according to routine clinical practice, will be collected at all visits.","other_id":"A6181215","observational_model":"Other","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"The Chinese adult with progressive advanced or metastatic well-differentiated unresectable\r\n        pancreatic neuroendocrine tumors is the target population.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Evidence of a personally signed and dated informed consent document indicating that\r\n             the subject (or a legally acceptable representative) has been informed of all\r\n             pertinent aspects of the study.\r\n\r\n          -  Subjects who are willing to follow up visits within current clinical practice.\r\n\r\n          -  Histologically or cytologically proven diagnosis of well-differentiated pancreatic\r\n             neuroendocrine tumors (according to WHO 2000 classification)\r\n\r\n          -  Unresectable (as assessed by the investigator) or metastatic disease documented on a\r\n             scan\r\n\r\n          -  A minimum age of 18 years\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with poorly-differentiated pancreatic neuroendocrine tumors (according to WHO\r\n             2000 classification)\r\n\r\n          -  Patients who have received at least one dosage of sunitinib treatment prior to signing\r\n             informed consent form will be excluded from participating in this study.\r\n      ","sponsor":"Pfizer","sponsor_type":"Industry","conditions":"Pancreatic Neuroendocrine Tumors","interventions":[{"intervention_type":"Drug","name":"Drug: sunitinib","description":"subjects will be enrolled to receive at least one dose of sunitinib orally at 37.5 mg once a day on a continuous daily dosing regimen (CDD) or dosage modification is based on daily clinic practice"}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs)","time_frame":"Every 2 to 4 weeks up to 8 years","description":"An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to <X> days after last dose that were absent before treatment or that worsened relative to pretreatment state."},{"outcome_type":"secondary","measure":"Progression-Free Survival (PFS)","time_frame":"Every 1 to 6 months up to 8 years","description":"the time from enrollment to first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS data will be censored on the date of the last tumor assessment on study for subjects who do not have objective tumor progression and who do not die while on study. Subjects lacking an evaluation of tumor response after enrollment will have their PFS time censored on the date of enrollment."},{"outcome_type":"secondary","measure":"Overall Survival (OS)","time_frame":"Up to 2 years","description":"the time from enrollment to documentation of death due to any cause. Subjects who withdraw from study will have their OS time censored on the date of withdrawal, and subjects who remain alive after study completion will have their OS time censored on the last date known to be alive."},{"outcome_type":"secondary","measure":"Probability of 5 years Participant Survival","time_frame":"Up to 9 years","description":"the percentage of patients who stay alive till after 5 years from enrollment."},{"outcome_type":"secondary","measure":"Progression-free survival by clinical judgment","time_frame":"Every 1 to 6 months up to 8 years","description":"the time from enrollment to first document of objective tumor progression, or first time tumor progression diagnosed by investigator based on clinical judgment, or death due to any cause, whichever occurs first."}]}
{"nct_id":"NCT02292758","start_date":"2014-12-12","phase":"Phase 2","enrollment":36,"brief_title":"Irinotecan and Cetuximab With or Without Bevacizumab in Treating Patients With RAS Wild-Type Locally Advanced or Metastatic Colorectal Cancer That Cannot Be Removed by Surgery","official_title":"BOND-3: A Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Irinotecan, Cetuximab, and Bevacizumab Compared With Irinotecan, Cetuximab, and Placebo in RAS-Wildtype, Irinotecan-Refractory, Metastatic Colorectal Cancer","primary_completion_date":"2019-03-20","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-09-27","last_update":"2020-02-28","description":"This randomized phase II trial studies how well irinotecan and cetuximab with or without bevacizumab work in treating patients with RAS wild-type colorectal cancer that has spread to other places in the body (locally advanced/metastatic) and cannot be removed by surgery. Irinotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as cetuximab and bevacizumab, may help the body?s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving irinotecan and cetuximab with or without bevacizumab may work betting in treating patients with colorectal cancer.","other_id":"RU021302I","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Metastatic or locally advanced (unresectable) colorectal cancer with histological\r\n             confirmation of adenocarcinoma\r\n\r\n          -  Measurable disease\r\n\r\n          -  RAS wild-type tumor; Note: evidence of EGFR expression in the tumor is not required\r\n\r\n          -  Previous failure of at least one fluoropyrimidine- and irinotecan-containing\r\n             chemotherapy regimen for metastatic disease; Note: previous failure is defined as\r\n             disease progression while receiving treatment or within 6 weeks after the last dose of\r\n             irinotecan; failure for this assessment is defined as any enlargement of measurable or\r\n             assessable lesion(s) or the development of any new lesion; a rising tumor marker alone\r\n             is not sufficient to define failure; patients can have received irinotecan in any\r\n             previous line of therapy\r\n\r\n          -  Treatment with bevacizumab in at least one prior line of therapy for metastatic\r\n             disease\r\n\r\n          -  Negative serum or urine pregnancy test done =< 7 days prior to registration, for women\r\n             of childbearing potential only\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0 or 1\r\n\r\n          -  Total serum bilirubin =< institutional upper limit of normal (ULN) obtained =<14 days\r\n             prior to randomization\r\n\r\n          -  Absolute neutrophil count (ANC) >= 1500/mm^3 obtained =<14 days prior to randomization\r\n\r\n          -  Platelet count >= 100,000/mm^3 obtained =<14 days prior to randomization\r\n\r\n          -  Hemoglobin >= 9.0 g/dL (hemoglobin may be supported by transfusion) obtained =<14 days\r\n             prior to randomization\r\n\r\n          -  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN (=< 5\r\n             x ULN for subjects with liver involvement of their cancer) obtained =<14 days prior to\r\n             randomization\r\n\r\n          -  Creatinine within institutional limits of normal OR creatinine clearance >= 60\r\n             mL/min/1.73 m^2 for patients with creatinine levels above institutional normal\r\n             obtained =<14 days prior to randomization\r\n\r\n          -  Urinary protein =< 1+ obtained =<14 days prior to randomization\r\n\r\n               -  Patients discovered to have >= 2+ proteinuria must have a spot urine\r\n                  protein:creatinine ratio (UPCR) < 1.0\r\n\r\n          -  Partial thromboplastin time (PTT) =< 1 x institutional ULN and international\r\n             normalized ratio (INR) =< 1.5 , unless participant is on full dose anticoagulation\r\n             therapy obtained =<14 days prior to randomization; patients on full-dose\r\n             anticoagulation are eligible if the following criteria are met:\r\n\r\n               -  Patient has an in-range INR (usually 2-3) on a stable dose of warfarin or other\r\n                  anticoagulant =< 14 days or is on a stable dose of low molecular weight heparin\r\n\r\n               -  Patient has no active bleeding or pathological condition that carries a high risk\r\n                  of bleeding (i.e., tumor involving major vessels or known varices)\r\n\r\n               -  Patients receiving anti-platelet agents are eligible; in addition, patients who\r\n                  are on daily prophylactic aspirin or anticoagulation for atrial fibrillation are\r\n                  eligible\r\n\r\n          -  Life expectancy > 3 months\r\n\r\n          -  Provide informed written consent\r\n\r\n          -  Willing to provide blood samples for mandatory correlative and research purposes\r\n\r\n          -  Willing to provide tissue and blood samples for mandatory banking purposes\r\n\r\n          -  Any major surgery or open biopsy completed >= 4 weeks prior to randomization\r\n\r\n          -  Any minor surgery or core biopsy completed >= 1 week prior to randomization and\r\n             patient must have fully recovered from the procedure; Note: insertion of a vascular\r\n             access device is not considered major or minor surgery\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Presence of a RAS mutation in exons 2, 3, or 4 of KRAS or NRAS (patients with\r\n             mutations in exons 2, 3, or 4 of KRAS and/or NRAS are excluded)\r\n\r\n          -  Prior treatment with cetuximab or panitumumab\r\n\r\n          -  Prior intolerance to irinotecan and/or bevacizumab despite dose reduction\r\n\r\n          -  Known or suspected brain or central nervous system (CNS) metastases, or carcinomatous\r\n             meningitis\r\n\r\n          -  Active, uncontrolled infection, including hepatitis B, hepatitis C\r\n\r\n          -  Concurrent anti-cancer therapy, including chemotherapy agents, targeted agents, or\r\n             biological agents not otherwise specified in this protocol\r\n\r\n          -  Anti-cancer therapy =< 14 days prior to randomization\r\n\r\n          -  Prior radiotherapy to > 25% of bone marrow; Note: standard rectal cancer\r\n             chemoradiation will not exclude subject from study protocol\r\n\r\n          -  Radiation therapy =< 2 weeks prior to randomization\r\n\r\n          -  Any of the following:\r\n\r\n               -  Pregnant women\r\n\r\n               -  Nursing women\r\n\r\n               -  Men or women of childbearing potential who are unwilling to employ adequate\r\n                  contraception\r\n\r\n          -  Co-morbid systemic illnesses or other severe concurrent disease, history of any\r\n             psychiatric or addictive disorder, or laboratory abnormality, which, in the judgment\r\n             of the investigator, would make the patient inappropriate for entry into this study or\r\n             interfere significantly with the proper assessment of safety and toxicity of the\r\n             prescribed regimens\r\n\r\n          -  Patients known to be human immunodeficiency virus (HIV) positive\r\n\r\n          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active\r\n             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac\r\n             arrhythmia, symptomatic pulmonary fibrosis or interstitial pneumonitis, or psychiatric\r\n             illness/social situations that, in the opinion of the investigator, may increase the\r\n             risks associated with study participation or study treatment, or may interfere with\r\n             the conduct of the study or the interpretation of the study results\r\n\r\n          -  Receiving any other investigational agent which would be considered as a treatment for\r\n             the primary neoplasm\r\n\r\n          -  Other active malignancy =< 3 years prior to registration; EXCEPTIONS: non-melanoma\r\n             skin cancer, prostatic intraepithelial neoplasia without evidence of prostate cancer,\r\n             lobular carcinoma in situ in one breast, or carcinoma-in-situ of the cervix that has\r\n             been treated\r\n\r\n          -  History of prior malignancy for which patient is receiving other specific treatment\r\n             for their cancer\r\n\r\n          -  History of allergic reactions attributed to compounds of similar chemical or biologic\r\n             composition to irinotecan, cetuximab, and/or bevacizumab that led to discontinuation\r\n             of those agents\r\n\r\n          -  Significant history of bleeding events or pre-existing bleeding diathesis =< 6 months\r\n             of randomization (unless the source of bleeding has been resected)\r\n\r\n          -  History of gastrointestinal perforation =< 12 months prior to randomization\r\n\r\n          -  Predisposing colonic or small bowel disorders in which the symptoms are uncontrolled\r\n             as indicated by baseline pattern of > 3 loose stools daily in subjects without a\r\n             colostomy or ileostomy; subjects with a colostomy or ileostomy may be entered at\r\n             investigator discretion\r\n\r\n          -  Arterial thrombotic events =< 6 months prior to randomization; Note: this includes\r\n             transient ischemic attack (TIA), cerebrovascular accident (CVA), unstable angina or\r\n             angina requiring surgical or medical intervention in the past 6 months, or myocardial\r\n             infarction (MI)\r\n\r\n          -  Clinically significant peripheral artery disease (e.g., claudication with < 1 block)\r\n             or any other arterial thrombotic event\r\n\r\n          -  Serious or non-healing wound, ulcer, or bone fracture\r\n\r\n          -  History of hypertension not well-controlled (>= 160/90) even though on a regimen of\r\n             anti-hypertensive therapy\r\n\r\n          -  Evidence of Gilbert?s syndrome or known homozygosity for the UGT1A1*28 allele (special\r\n             screening not required)\r\n      ","sponsor":"Academic and Community Cancer Research United","sponsor_type":"Other","conditions":"Colorectal Adenocarcinoma|RAS Wild Type|Stage IV Colorectal Cancer AJCC v7|Stage IVA Colorectal Cancer AJCC v7|Stage IVB Colorectal Cancer AJCC v7","interventions":[{"intervention_type":"Biological","name":"Biological: Bevacizumab","description":"Given IV"},{"intervention_type":"Biological","name":"Biological: Cetuximab","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: Irinotecan","description":"Given IV"},{"intervention_type":"Other","name":"Other: Laboratory Biomarker Analysis","description":"Correlative studies"},{"intervention_type":"Other","name":"Other: Placebo","description":"Given IV"}],"outcomes":[{"outcome_type":"primary","measure":"Progression-Free Survival (PFS)","time_frame":"From the date of randomization to the date of 1st documented disease progression or death due to any cause, whichever occurs first, assessed up to 24 months","description":"The distribution of PFS by group will be estimated using the method of Kaplan-Meier. Median by treatment group with confidence intervals will be estimated based on Kaplan-Meier curves. The hazard ratio (HR) with confidence interval will be estimated based on stratified Cox models (stratified by levels of stratification factors), without and with adjusting for baseline clinical/pathological factors. Progression (PD) is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. PD: Any new lesion or increase by ≥50% of previously involved sites from nadir)."},{"outcome_type":"primary","measure":"6-month and 12-month Progression-free Survival (PFS) Rates","time_frame":"From the date of randomization to the date of 1st documented disease progression or death due to any cause, whichever occurs first, assessed up to 24 months","description":"The distribution of PFS by group will be estimated using the method of Kaplan-Meier. Six and 12 month PFS rates by treatment group with confidence intervals will be estimated based on Kaplan-Meier curves. The hazard ratio (HR) with confidence interval will be estimated based on stratified Cox models (stratified by levels of stratification factors), without and with adjusting for baseline clinical/pathological factors. Progression (PD) is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. PD: Any new lesion or increase by ≥50% of previously involved sites from nadir)."},{"outcome_type":"secondary","measure":"Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Events","time_frame":"Up to 30 days from last dose of study treatment","description":"The number of participants who experienced at least one grade 3 or higher adverse events assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0."},{"outcome_type":"secondary","measure":"Overall Survival (OS)","time_frame":"From randomization to the date of death due to any cause, assessed up to 24 months","description":"The distribution of OS by group will be estimated using the method of Kaplan-Meier. Median OS by treatment group with confidence intervals will be estimated based on Kaplan-Meier curves. The HR with confidence interval will be estimated based on stratified Cox models (stratified by levels of stratification factors), without and with adjusting for baseline clinical/pathological factors."},{"outcome_type":"secondary","measure":"12-month, 18-month, and 24-month Overall Survival (OS) Rates","time_frame":"From randomization to the date of death due to any cause, assessed up to 24 months","description":"The distribution of OS by group will be estimated using the method of Kaplan-Meier. Twelve, 18- and 24-month survival rates by treatment group with confidence intervals will be estimated based on Kaplan-Meier curves. The HR with confidence interval will be estimated based on stratified Cox models (stratified by levels of stratification factors), without and with adjusting for baseline clinical/pathological factors."},{"outcome_type":"secondary","measure":"Disease Control Rate (DCR)","time_frame":"Up to 2 years","description":"Disease control is defined as maintaining Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) as the tumor assessment result during the defined time window. DCR (percentage) is defined as number of patients with success of disease control divided by total number of patients in the analysis population multiplied by 100, excluding patients who refuse treatment before the initiation of any treatment. CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by ≥50% of previously involved sites from nadir, SD: Neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD taking as reference the MSD"},{"outcome_type":"secondary","measure":"Overall Response Rate (ORR)","time_frame":"Up to 2 years","description":"The response rate (percentage) is the percent of participants whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients. Response rates (including complete and partial response) will be tested using Fisher's exact test. CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites"},{"outcome_type":"secondary","measure":"Duration of Response (DOR)","time_frame":"From the date of first tumor assessment with the response status being CR or PR to the date of 1st documented progressive disease, assessed up to 12 months","description":"The distribution of DOR by treatment group will be estimated using the method of Kaplan-Meier. Six and 12 month durable response (i.e. maintaining CR or PR without progressive disease [PD]) rates by treatment group with confidence intervals will be estimated based on Kaplan-Meier curves. The HR with confidence interval will be estimated based on stratified Cox models (stratified by levels of stratification factors), without and with adjusting for baseline clinical/pathological factors.CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by ≥50% of previously involved sites from nadir"},{"outcome_type":"secondary","measure":"Percentage of Participants With Treatment Failure at 6 Months","time_frame":"assessed at 6 months","description":"TTF is defined as the time from the date of randomization to the date of treatment discontinuation due to PD, death, or severe AE. The distribution of TTF by treatment group will be estimated using the method of Kaplan-Meier. Six month event-free rates by treatment group with confidence intervals will be estimated based on Kaplan-Meier curves. The HR with confidence interval will be estimated based on stratified Cox models (stratified by levels of stratification factors), without and with adjusting for baseline clinical/pathological factors. PD: Any new lesion or increase by ≥50% of previously involved sites from nadir"},{"outcome_type":"secondary","measure":"Relative Dose Intensity (RDI)","time_frame":"Up to 2 years","description":"RDI is defined as the total dose of protocol therapy a patient actually received (i.e., summation of actually received dose at each cycle) divided by the total planned dose (i.e., summation of planned dose level at each cycle) multiplied by 100. Separate RDIs will be calculated for irinotecan and cetuximab. Agent-specific RDI will be summarized by medians, and min and max values, all of which will be compared between the two treatment groups by the Wilcoxon Rank sum test."},{"outcome_type":"other","measure":"Change in Genotype Concentrations of Prespecified Gene Mutations in Circulating Cell-free Deoxyribonucleic Acid (DNA) (cfDNA)","time_frame":"Baseline up to 2 years","description":"The mean and median change in mutation concentration for each prespecified gene, and provide the corresponding 95% confidence intervals will be estimated. Cox proportional hazards models will be applied to explore the predictive value of pretreatment mutation status for cetuximab sensitivity and resistance, using PFS and OS as the outcome variables."},{"outcome_type":"other","measure":"Dynamic Change in Mutation Concentration While the Patient is Receiving Cetuximab Treatment","time_frame":"Baseline up to 2 years","description":"Scatter plots and box plots will be used to illustrate such change."}]}
{"nct_id":"NCT02391181","start_date":"2014-11-30","phase":"Phase 1","enrollment":30,"brief_title":"Bioequivalence Study With Pharmacokinetic Endpoints, Comparing a Single Dose of Iron Sucrose Azad Injection of Azad Pharma Corporation (AG), With a Single Dose of Venofer Injection of Vifor Corporation (AG) in Healthy Adult Volunteers","official_title":"An Open-label, Randomized, Crossover-design Bioequivalence Study With Pharmacokinetic Endpoints, Comparing a Single Dose of Iron Sucrose Azad Injection of Azad Pharma Corporation (AG), With a Single Dose of Venofer Injection of Vifor Corporation (AG) in Healthy Adult Volunteers Under Fasting Conditions","primary_completion_date":"2015-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-08-31","last_update":"2015-10-02","description":"A Clinical Trial to Demonstrate the Comparability of the Two Iron Sucrose Injection Solutions Iron Sucrose Azad of Azad Pharma AG and Venofer of Vifor Pharma AG. The Hypothesis is That Both Iron Sucrose Injection Solutions Reveal the Same Active Substance Availability in the Blood Circuit.","other_id":"AZAD-BE01","allocation":"Randomized","intervention_model":"Crossover Assignment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male and female healthy volunteers within the age range of 18 to 45 years (both\r\n             inclusive)\r\n\r\n          -  Comprehension of the nature and purpose of the study and willingness to comply with\r\n             the requirements of the entire procedure\r\n\r\n          -  Subjects of good health based on previous medical history, physical examination, vital\r\n             signs, electrocardiogram (ECG), and clinical laboratory tests assessed at the time of\r\n             screening.\r\n\r\n          -  Ferritin levels  30 g/l for female and male subjects\r\n\r\n          -  Transferrin  200 mg/dl for female and male subjects\r\n\r\n          -  Hemoglobin levels  12 g/dl for female subjects and  13.5 g/dl for male subjects\r\n\r\n          -  Females of childbearing potential must provide a negative urine pregnancy test at time\r\n             of screening and have to be compliant with effective hormonal form of birth control\r\n             throughout the whole study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subjects with a BMI of < 19 kg/m2 and > 30 kg/m2\r\n\r\n          -  Pregnancy (as determined by a positive urine pregnancy test at the screening or prior\r\n             each crossover phase) or breast feeding\r\n\r\n          -  Females with history of hypermenorrhea or menorrhagia\r\n\r\n          -  Females with history of myoma, endometriosis or uterus hypoplasia or any other\r\n             gynecological disorder\r\n\r\n          -  History of iron deficiency within six months prior screening\r\n\r\n          -  History of anemia within 1 year prior screening\r\n\r\n          -  Presence of iron overload or disturbances in utilization of iron\r\n\r\n          -  History or evidence of allergy or hypersensitivity to the active substance Iron\r\n             Sucrose of both test and reference product, the finished test and reference product or\r\n             any of its excipients (water for injection, sodium hydroxide)\r\n\r\n          -  Hypersensitivity to other parenteral iron products\r\n\r\n          -  Use of iron supplements or iron containing herbal or nutritional supplements within\r\n             last three months prior to start of the study\r\n\r\n          -  History of difficulty with donating blood or difficulty in accessibility of veins in\r\n             left and right arm\r\n\r\n          -  Donation of blood (one unit or 350 mL) within last three months prior first dose\r\n             administration of the study drug\r\n\r\n          -  Evidence of an active or suspected cancer, or a history of malignancy within the last\r\n             2 years, with the exception of patients with basal cell carcinoma that has been\r\n             excised and cured\r\n\r\n          -  History of any systemic anti-neoplastic or immunomodulatory treatment (including\r\n             supraphysiologic doses of steroids and radiation) 6 months prior to the first dose of\r\n             study drug or the expectation that such treatment will be needed at any time during\r\n             the study\r\n\r\n          -  History of bleeding disorders or anticoagulant use\r\n\r\n          -  History or other evidence of chronic pulmonary or cardiovascular disease associated\r\n             with functional limitation\r\n\r\n          -  History of uncontrolled severe seizure disorder.\r\n\r\n          -  Any signs of acute infection or inflammation.\r\n\r\n          -  History or other evidence of severe illness, or any other condition which would make\r\n             the subject in the opinion of the investigator, unsuitable for the study\r\n\r\n          -  Any clinically significant abnormal laboratory values on the laboratory evaluations,\r\n             medical history or physical examination at the screening\r\n\r\n          -  Positive Human Immunodeficiency Virus (HIV)/ Hepatitis B Virus (HBV)/ hepatitis C\r\n             virus (HCV) serology tests at the time of the screening visit\r\n\r\n          -  Abnormal 12-lead ECG at the time of screening that is considered to be clinically\r\n             significant\r\n\r\n          -  History or presence of severe or medical treated allergies or immune or inflammatory\r\n             conditions (eg. systemic lupus erythematosus, rheumatoid arthritis)\r\n\r\n          -  History of atopic allergy associated with severe asthma\r\n\r\n          -  Recent history or ongoing kidney or liver dysfunction\r\n\r\n          -  Any other major illness in last three months or any significant ongoing chronic\r\n             medical illness\r\n\r\n          -  Subjects who regularly use more than 2 units of alcohol per day (one unit of alcohol\r\n             equals  liter of beer, 200mL wine or 50mL of spirits)or there is evidence of Cocaine,\r\n             Amphetamines, Metformin, Tetrahydrocannabinol (THC), Methadone,\r\n             3,4-Methylendioxy-N-Methylamphetamin (MDMA), Morphine, Barbiturates, Benzodiazepines\r\n             and Tricyclic antidepressants in urine at the screening)\r\n\r\n          -  Heavy smokers (> 10 cigarettes/day) in the last three months prior to start of the\r\n             study\r\n\r\n          -  Any concomitant medication (except paracetamol and contraceptives) within the last two\r\n             weeks, including over-the-counter and herbal products, prior to receiving the dose of\r\n             study medication\r\n\r\n          -  Participation in any clinical trial within last one months\r\n\r\n          -  Subjects who are considered by the investigator to be non-compliant or unlikely to\r\n             complete the study.\r\n      ","sponsor":"Azad Pharma AG","sponsor_type":"Industry","conditions":"Healthy Volunteers","interventions":[{"intervention_type":"Drug","name":"Drug: Iron Sucrose Azad","description":"Test product Iron Sucrose Azad will be administered intravenously via a 18 gauge (18G) needle. For intravenous injection, a 5 mL single dose of test product (each mL containing 20 mg/mL elemental iron as iron sucrose in water for injection) will be diluted in 0.9% isotonic sterile sodium chloride (NaCl) up to 15 mL. The injection solution will be intravenously administered to the forearm vein, resulting in a total injection volume of 15 mL administered over a period of 5 minutes."},{"intervention_type":"Drug","name":"Drug: Venofer","description":"Reference product Venofer will be administered intravenously via a 18 gauge (18G) needle. For intravenous injection, a 5 mL single dose of reference product (each mL containing 20 mg/mL elemental iron as iron sucrose in water for injection) will be diluted in 0.9% isotonic sterile sodium chloride (NaCl) up to 15 mL. The injection solution will be intravenously administered to the forearm vein, resulting in a total injection volume of 15 mL administered over a period of 5 minutes."}],"outcomes":[{"outcome_type":"primary","measure":"Comparative assessment of peak plasma concentration (Cmax) of baseline corrected total serum iron and serum transferrin-bound iron after administration of test and reference product.","time_frame":"-24.00, -12.00, -3.00 hours, at pre-dose (within 15 minutes prior to dosing), at 2, 5, 10, 15, 20, 30, 45 minutes and at 1.00, 1.30, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 hours post-dose."},{"outcome_type":"primary","measure":"Comparative assessment of the area under the plasma concentration versus time curve (AUC) of baseline corrected total serum iron and serum transferrin-bound iron after administration of test and reference product.","time_frame":"-24.00, -12.00, -3.00 hours, at pre-dose (within 15 minutes prior to dosing), at 2, 5, 10, 15, 20, 30, 45 minutes and at 1.00, 1.30, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 hours post-dose."},{"outcome_type":"secondary","measure":"Comparative assessment of peak plasma concentration (Cmax) of non-baseline corrected total serum iron and serum transferrin-bound iron after administration of test and reference product.","time_frame":"-24.00, -12.00, -3.00 hours, at pre-dose (within 15 minutes prior to dosing), at 2, 5, 10, 15, 20, 30, 45 minutes and at 1.00, 1.30, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 hours post-dose."},{"outcome_type":"secondary","measure":"Comparative assessment of the area under the plasma concentration versus time curve (AUC) of non-baseline corrected total serum iron and serum transferrin-bound iron after administration of test and reference product.","time_frame":"-24.00, -12.00, -3.00 hours, at pre-dose (within 15 minutes prior to dosing), at 2, 5, 10, 15, 20, 30, 45 minutes and at 1.00, 1.30, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00 hours post-dose."}]}
{"nct_id":"NCT02277158","start_date":"2014-11-30","phase":"Phase 1","enrollment":18,"brief_title":"Phase I Study of CCRT as Adjuvant Treatment for Stage II/III Operable Rectal Cancer.","official_title":"A Phase I Study of Concurrent Radiotherapy and Tegafur, Gimeracil and Oteracil Potassium Capsule(S-1) as Adjuvant Treatment for Stage II/III Operable Rectal Cancer.","primary_completion_date":"2015-06-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2015-12-31","last_update":"2014-12-02","description":"The purpose of this study is to determine the maximum tolerated dose and safety of S-1 plus radiotherapy for patients with rectal cancer","other_id":"DP03182014","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  R0 resection of histologically proved stage II/III rectal cancer;\r\n\r\n          -  18-75 years old;\r\n\r\n          -  No previous radiotherapy or chemotherapy for rectal cancer;\r\n\r\n          -  Performance status of ECOG 0,1;\r\n\r\n          -  Adequate organ function defined as below:\r\n\r\n             i. WBC  4,000/mm^3 ii. ANC  1,500/mm^3 iii. Hemoglobin  10g/dL iv. Platelet \r\n             100,000/m^3 v. Total bilirubin  1.5ULN vi. AST/ALT  1.5ULN vii. Serum creatinine \r\n             1.5ULN or creatinine clearance rate  60ml/minUrea nitrogen  1.5ULN viii. Protein in\r\n             urine dipstick test<1+; if the test result >1+ ,total protein in urea must <500mg\r\n             within 24 hours\r\n\r\n          -  Able to receive oral administration\r\n\r\n          -  Informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Hypersensitive to S-1 or its excipients\r\n\r\n          -  Pulmonary fibrosis or interstitial pneumonitis found within 28 days prior to\r\n             registration\r\n\r\n          -  Significant co-morbid medical conditions, including, but not limited to, heart\r\n             failure, renal failure, hepatic failure, hemorrhagic peptic ulcer, mechanical or\r\n             paralytic ileus, or poorly controlled diabetes\r\n\r\n          -  Received any investigational drug or anti-cancer agent\r\n\r\n          -  Pregnant or lactating female or pregnancy test positive\r\n\r\n          -  Severe mental disorder\r\n\r\n          -  Judged ineligible by physicians for participation in the study due to safety concern.\r\n      ","sponsor":"Daping Hospital and the Research Institute of Surgery of the Third Military Medical University","sponsor_type":"Other","conditions":"Rectal Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Chemoradiotherapy","description":"S-1 CCRT"}],"outcomes":[{"outcome_type":"primary","measure":"Maximum Tolerated Dose (MTD)","time_frame":"6weeks (42 days)"},{"outcome_type":"secondary","measure":"Dose Limiting Toxicities (DLTs)","time_frame":"6weeks (42 days)"},{"outcome_type":"secondary","measure":"Quality of Life","time_frame":"6weeks (42 days)"}]}
{"nct_id":"NCT02756143","start_date":"2014-11-30","phase":"N/A","enrollment":125,"brief_title":"Exercise During Pregnancy and Perinatal Outcome","official_title":"Exercise During Pregnancy and Perinatal Outcome. Randomized Controlled Trial","primary_completion_date":"2016-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-02-28","last_update":"2017-10-27","description":"Effect of Physical Exercise Program on fetoplacental circulation and perinatal outcome.","other_id":"PERINATEXER","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy and able to exercise following American College of Obstetricians and\r\n             Gynecologists (ACOG) guidelines\r\n\r\n          -  Able to communicate in spanish\r\n\r\n          -  Giving birth at Torrejon Universitary Hospital\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Medical or obstetric complication excluding exercise ( ACOG guideline)\r\n\r\n          -  Interested in the study after 18 weeks or pregnancy\r\n\r\n          -  Not availability to attend to the physical exercise program\r\n      ","sponsor":"University Hospital of Torrejon","sponsor_type":"Other","conditions":"Pregnancy|Healthy","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Exercise","description":"Supervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (from week 9 to 38). Each session consists of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training.\r\nAerobic activity was prescribed at light to moderate intensity, aiming for 55-60% of heart rate reserve. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate."}],"outcomes":[{"outcome_type":"primary","measure":"Maternal weight gain during pregnancy","time_frame":"From the beginning of the pregnancy to 1 month postdelivery"},{"outcome_type":"secondary","measure":"Cesarean Section Rate","time_frame":"Birth"},{"outcome_type":"secondary","measure":"Gestational Diabetes","time_frame":"Birth"},{"outcome_type":"secondary","measure":"Preeclampsia","time_frame":"birth"},{"outcome_type":"secondary","measure":"Fetal TAPSE","time_frame":"up to 36 weeks of pregnancy","description":"Tricuspid Annular Plane Systolic Excursion meassured by echocardiogram"},{"outcome_type":"secondary","measure":"Fetal Tei Index","time_frame":"up to 36 weeks of pregnancy","description":"Myocardial Performance Index meassured by echocardiogram"},{"outcome_type":"secondary","measure":"Ductus Arteriosus PI","time_frame":"up to 36 weeks","description":"Ductus Arteriosus Pulsatility Index meassured by echocardiogram"},{"outcome_type":"secondary","measure":"Aortic Isthmus PI","time_frame":"up to 36 weeks","description":"Aortic Isthmus Pulsatility Index meassured by echocardiogram"},{"outcome_type":"secondary","measure":"Fetal Heart Rate Variability","time_frame":"birth","description":"Fetal Heart Rate Variability meassured by cardiotocogram"},{"outcome_type":"secondary","measure":"Newborn weight","time_frame":"birth","description":"birth"},{"outcome_type":"secondary","measure":"Placental weight","time_frame":"birth"}]}
{"nct_id":"NCT02661399","start_date":"2014-11-30","enrollment":100,"brief_title":"Peripheral Blood Biomarkers Associated With CIPN","official_title":"Investigation of Peripheral Blood Biomarkers Associated With CIPN","primary_completion_date":"2017-05-08","study_type":"Observational","rec_status":"Completed","completion_date":"2020-12-10","last_update":"2020-12-17","description":"The investigators are doing a research study that will teach us about the tingly pain that people develop when they get chemotherapy.","other_id":"24834","observational_model":"Other","time_perspective":"Other","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients who have diagnoses which might be treated with CIPN causing therapy, and/or who\r\n        have CIPN symptoms without potential confounding neuropathies (antecedent diabetic or\r\n        anatomical peripheral neuropathies).","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosis of a tumor for which Platinums, Vinca Alkaloids, Bortezomib or Taxanes are\r\n             indicated\r\n\r\n          -  No prior history of diabetic, anatomical or regional neuropathies (except pre-existing\r\n             CIPN)\r\n\r\n          -  Age  18 years\r\n\r\n          -  Capable of understanding the investigational nature, potential risks and benefits of\r\n             the study, and able to provide valid informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Inability to give consent\r\n\r\n          -  Inability to tolerate venipuncture for any reason\r\n\r\n          -  Age < 18 years\r\n\r\n          -  Any known medical, surgical or psychiatric condition that may interfere with the\r\n             conduct of the study or be detrimental to the donor in the opinion of the PI or caring\r\n             physician\r\n\r\n          -  Consent Refusal by patient\r\n      ","sponsor":"St. Louis University","sponsor_type":"Other","conditions":"Peripheral Neuropathy, Secondary to Drugs or Chemicals","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Collection of blood samples, medical history, CIPN symptomology (via questionnaire) and clinical laboratory data for a correlative evaluation of potential CIPN related molecular and cellular variance (biomarkers).","time_frame":"3 years","description":"Variant S1P/S1PR related biomarkers; CIPN Questionnaire for Blood Collection Protocol (non-standardized questionnaire, 0-4 rating scales, 0 = no symptoms, 4 = very severe symptoms, symptoms: neuropathic pain severity/unpleasantness, sharpness, depth, tingling, numbness)"}]}
{"nct_id":"NCT02745327","start_date":"2014-11-30","enrollment":270,"brief_title":"Nutrition, Overgrowth, and Vaccine Efficacy in Low-income Settings","official_title":"A Longitudinal Study of Childhood Intestinal Bacterial Overgrowth, Vaccine Underperformance, and Malnutrition","primary_completion_date":"2018-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2018-12-31","last_update":"2019-05-15","description":"The purpose of this study is to assess the impact of small intestine bacterial overgrowth (SIBO) on childhood nutritional status, growth, and oral vaccine efficacy.","other_id":"PR14083","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","maximum_age":0.01918,"population":"Bangladeshi infants from the low-income neighborhood of Mirpur, Dhaka","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Child previously enrolled in the FIELD STUDIES protocol (enrollments in both studies\r\n             may occur simultaneously)\r\n\r\n          -  Mother willing to sign informed consent form.\r\n\r\n          -  Healthy infant aged less than 7 days old\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Parents are not willing to have child's blood drawn, oral fluid collected, urine\r\n             collected, or breath testing performed.\r\n\r\n          -  History of seizures, other apparent neurologic disorders, or other congenital\r\n             abnormalities involving major organ systems.\r\n      ","sponsor":"University of Virginia","sponsor_type":"Other","conditions":"Small Intestine Bacterial Overgrowth","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Glucose-Hydrogen Breath Test","time_frame":"Birth to 2 years","description":"Test for Small Intestine Bacterial Overgrowth"},{"outcome_type":"secondary","measure":"Fecal Regenerating Islet-Derived 1 Beta (Reg 1B)","time_frame":"Birth to 2 years"},{"outcome_type":"secondary","measure":"Fecal Myeloperoxidase","time_frame":"Birth to 2 years"},{"outcome_type":"secondary","measure":"Serum 25-OH vitamin D","time_frame":"Birth to 2 years"},{"outcome_type":"secondary","measure":"Serum Zinc","time_frame":"Birth to 2 years"},{"outcome_type":"secondary","measure":"Serum Retinol Binding Protein","time_frame":"Birth to 2 years"},{"outcome_type":"secondary","measure":"Serum Cobalamin","time_frame":"Birth to 2 years"},{"outcome_type":"secondary","measure":"Serum Albumin","time_frame":"Birth to 2 years"},{"outcome_type":"secondary","measure":"Lactulose mannitol ratio","time_frame":"12 weeks of age"},{"outcome_type":"secondary","measure":"Serum Tetanus antibody titers","time_frame":"Birth to 2 years"},{"outcome_type":"secondary","measure":"Serum Polio antibody titers to sabin strains","time_frame":"Birth to 2 years"},{"outcome_type":"secondary","measure":"Oral fluid Tetanus antibody titers","time_frame":"Birth to 2 years"},{"outcome_type":"secondary","measure":"Height","time_frame":"Birth to 2 years"},{"outcome_type":"secondary","measure":"Weight","time_frame":"Birth to 2 years"},{"outcome_type":"secondary","measure":"Head circumference","time_frame":"Birth to 2 years"}]}
{"nct_id":"NCT02856139","start_date":"2014-11-30","enrollment":61,"brief_title":"Appearance of Far Peripheral Retina in Normal Eyes by Ultra-widefield Fluorescein Angiography","official_title":"The Director of the Fundus Center of Zhongshan Ophthalmic Center","primary_completion_date":"2016-01-31","study_type":"Observational","rec_status":"Completed","completion_date":"2016-01-31","last_update":"2016-08-04","description":"PURPOSE: To characterize the appearance of the far peripheral retina of normal eyes using ultra-widefield fluorescein angiography (UWFA). DESIGN: Prospective observational case series. METHODS: This study enrolled normal eyes with best corrected visual acuity  20/20, refractive error < 3.00D, and without visible retinal pathologic changes under a slit lamp-based condensing lens. The far peripheral retina was detected by UWFA. Ciliary body thickness (CBT) at 3 mm (CBT1) and 2 mm (CBT2) posterior to the scleral spur was measured by ultrasound biomicroscopy.","other_id":"2016036","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","maximum_age":70,"population":"Patients of the fundus outpatient clinic in Zhongshan ophthalmic center who meet the\r\n        standard of inclusion criteria.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  best corrected visual acuity  20/20\r\n\r\n          -  refractive error < 3.00D\r\n\r\n          -  without visible retinal pathologic changes under a slit lamp-based condensing lens\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  history of ocular surgery\r\n\r\n          -  presence of ocular or systemic diseases\r\n\r\n          -  opacity of refractive media, which interfered with the peripheral retina image quality\r\n      ","sponsor":"Sun Yat-sen University","sponsor_type":"Other","conditions":"Normal Eyes|Peripheral Retina","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Ultra-widefield fluorescein angiography findings at the far peripheral retina of normal eyes","time_frame":"from November 2014 to January 2016"},{"outcome_type":"secondary","measure":"Ciliary body thickness","time_frame":"from November 2014 to January 2016"}]}
{"nct_id":"NCT02294760","start_date":"2014-11-30","phase":"N/A","enrollment":16,"brief_title":"Long-term Sacral Nerve Stimulation for Irritable Bowel Syndrome.","official_title":"Long-term Efficacy of Sacral Nerve Stimulation for Irritable Bowel Syndrome. A Randomised Controlled Crossover Study","primary_completion_date":"2016-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-12-31","last_update":"2018-05-17","description":"A recent randomised, controlled, crossover study has shown that sacral nerve stimulation (SNS) significantly reduces symptoms and improves quality of life of highly selected patients with irritable bowel syndrome (IBS). Relief of IBS symptoms during SNS is associated with consistent changes in rectal sensitivity and biomechanical wall properties. The aim of the present study is to evaluate long-term efficacy of sacral nerve stimulation on symptoms and quality of life in patients with IBS in a randomised, placebo-controlled, crossover study.","other_id":"44418","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients who are psychologically stable and suitable for intervention and able to\r\n             provide informed consent\r\n\r\n          -  Patients who are diagnosed with IBS according to the Rome III criteria and\r\n             characterised with IBS-D or IBS-M.\r\n\r\n          -  Patients who have been treated with sacral nerve stimulation for a minimum of 3 years.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Other bowel diseases including inflammatory bowel disease\r\n\r\n          -  Pregnant or breast feeding\r\n\r\n          -  Patients who are considered unable to follow the planned programme of the study,\r\n             including mentally illness or physiological instability\r\n\r\n          -  Patients who are on medication with known influence on gastrointestinal motility\r\n             including those for thyroid disease, diabetes mellitus, celiac disease and\r\n             neurological diseases.\r\n      ","sponsor":"University of Aarhus","sponsor_type":"Other","conditions":"Irritable Bowel Syndrome","interventions":[{"intervention_type":"Device","name":"Device: OFF","description":"The stimulation is turned OFF."},{"intervention_type":"Device","name":"Device: Subsensory","description":"The stimulation is set to 90% of the sensory threshold."}],"outcomes":[{"outcome_type":"primary","measure":"The Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome version","time_frame":"Change in the IBS-specific symptom score between the subsensory and the OFF period in the crossover study","description":"The questionnaire is filled in every week of the 12 week study period"},{"outcome_type":"secondary","measure":"Irritable Bowel Syndrome - Impact Scale questionnaire","time_frame":"Change in the IBS-specific quality of life score between the subsensory and the OFF period in the crossover study","description":"The questionnaire is filled in every week of the 12 week study period"}]}
{"nct_id":"NCT02265081","start_date":"2014-11-30","phase":"N/A","enrollment":135,"brief_title":"A Prospective Study on USS Assessment of Pelvic Structures in 3rd Trimester of Pregnancy Versus Delivery Outcome","official_title":"A Prospective Study on USS Assessment of Pelvic Structures in 3rd Trimester of Pregnancy Versus Delivery Outcome.","primary_completion_date":"2015-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-07-31","last_update":"2015-07-28","description":"The proposed study is to evaluate if there are specific factors in the pelvic floor functional anatomy which can predict the ability of having a vaginal birth after caesarean section. Physical characteristics of the soft tissue in the female pelvis play an important role in successful vaginal delivery. A \"tight\" or less distensible pelvic floor muscles may influence mode of delivery, leading to poor labour progression and by compressing foetal head produce CTG abnormality such as decelerations, both resulting in caesarean delivery. One of the main structures of the pelvic floor, the puborectoalis muscle, facilitates the passage of fetal head through the birth canal by stretching and distending. Therefore distensibility of the female pelvic floor influences mode of delivery. Three hundred patients, in the third trimester of pregnancy, will be recruited via the antenatal clinics to minimize any disruption in their pregnancy care provision. Eligible participants are pregnant women who had either one or no vaginal births, or one caesarean section and who can give an informed consent and maintain their autonomy regarding mode of delivery with understanding of the forthcoming study results. Participants will be excluded if they sustain any obstetric complications that may impede on time and mode of delivery including an emergency prelabour caesarean section. Ultrasonographic assessment of the differences in the pelvic characteristics of these women will be used to predict a successful of trial of vaginal delivery after caesarean section (VBAC) in subsequent pregnancies. The results will be used to better inform whether there is a simple (single ultrasound assessment) that can be used to help inform women's choice regarding mode of delivery. Results from this research could be a pioneering blueprint for further studies, as there is very little known about this topic.","other_id":"U1111-1162-7720","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":16,"maximum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. English speaking women\r\n\r\n          2. over 16 years old women\r\n\r\n          3. women willing to provide written informed consent\r\n\r\n          4. women who had either prior vaginal delivery or caesarean section or no prior birth\r\n             experience\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Women who cannot give an informed consent,\r\n\r\n          2. under the age of consent,\r\n\r\n          3. any participants whose pregnancies complicated during the antenatal period that may\r\n             influence decision on time and mode of delivery that is anyone who has to undergo an\r\n             emergency prelabour LSCS,\r\n\r\n          4. nonEnglish speaking women\r\n\r\n          5. less than 16 years old women\r\n      ","sponsor":"Birmingham Women's NHS Foundation Trust","sponsor_type":"Other","conditions":"Pelvic Floor Disorders|Pregnancy","interventions":[{"intervention_type":"Procedure","name":"Procedure: ultrasound","description":"pelvic floor ultrasound"},{"intervention_type":"Procedure","name":"Procedure: uroflow-meter","description":"uroflow meter: measurement of passed urine volume"}],"outcomes":[{"outcome_type":"primary","measure":"vaginal delivery","time_frame":"12 months"},{"outcome_type":"secondary","measure":"voiding problems","time_frame":"12 months"}]}
{"nct_id":"NCT02166827","start_date":"2014-11-30","phase":"N/A","enrollment":1,"brief_title":"Effects of a NeuroAD System, for the Treatment of Alzheimer Disease","official_title":"Effects of a NeuroAD System, for the Treatment of Alzheimer Disease: a Randomized, Double-blinded, Placebo-controlled Study","primary_completion_date":"2015-11-30","study_type":"Interventional","rec_status":"Terminated","completion_date":"2015-11-30","last_update":"2017-03-31","description":"To evaluate the long-term efficacy of the NeuroAD system","other_id":"NRX-LT1","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":60,"maximum_age":90,"population":"","criteria":"\n        Main Inclusion Criteria:\r\n\r\n          1. Male or female age 60-90 years\r\n\r\n          2. Patients diagnosed with mild or moderate stage of Alzheimer's Disease, according to\r\n             the DSM-IV criteria\r\n\r\n          3. MMSE score 18 to 26\r\n\r\n          4. Physical clearance for study participation as evaluated by the clinician\r\n\r\n          5. Spouse, family member or professional caregiver agree and capable of taking care for\r\n             the participation of the patient in the study (answering questions regarding the\r\n             patient's condition and assuming responsibility for medication)\r\n\r\n          6. Informed consent by the patient or by legally authorized person if appointed\r\n\r\n        Main Exclusion Criteria:\r\n\r\n          1. CDR 0, 0.5 or 3\r\n\r\n          2. Severe agitation\r\n\r\n          3. Mental retardation\r\n\r\n          4. History of Epileptic Seizures or Epilepsy\r\n\r\n          5. Contraindication for performing MRI scanning\r\n\r\n          6. Contraindication for receiving TMS treatment according to a TMS questionnaire\r\n\r\n          7. Patients with metal implants in the head, (i.e. cochlear implants, implanted brain\r\n             stimulators and neurostimulators, aneurysm clips) with the exception of metal implants\r\n             in mouth\r\n\r\n          8. Cardiac pacemakers\r\n\r\n          9. Implanted medication pumps\r\n\r\n         10. Intracardiac lines\r\n\r\n         11. Significant heart disease\r\n\r\n         12. Currently taking medication that lower the seizure threshold\r\n      ","sponsor":"Neuronix Ltd","sponsor_type":"Industry","conditions":"Alzheimer's Disease","interventions":[{"intervention_type":"Device","name":"Device: NeuroAD","description":"Synchronized TMS and cognitive stimulation to 6 brain areas."},{"intervention_type":"Device","name":"Device: Sham TMS+Cog","description":"Sham Device, has the same appearance and sound as the real device, combined with sham cognitive exercises."}],"outcomes":[{"outcome_type":"primary","measure":"Efficacy","time_frame":"3 Months","description":"Change from Baseline to 3 months in ADAS-Cog score and CGI-C. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive. CGI-C: Clinical Global Impression of Change"},{"outcome_type":"secondary","measure":"Efficacy","time_frame":"7 weeks","description":"Change from Baseline to week 7 in ADAS-Cog score and CGI-C. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive. CGI-C: Clinical Global Impression of Change"},{"outcome_type":"secondary","measure":"Efficacy","time_frame":"6 Months","description":"Change from Baseline to 6 months in ADAS-Cog score and CGI-C. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive. CGI-C: Clinical Global Impression of Change"},{"outcome_type":"secondary","measure":"Efficacy","time_frame":"9 Months","description":"Change from Baseline to 9 months in ADAS-Cog score and CGI-C. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive. CGI-C: Clinical Global Impression of Change"},{"outcome_type":"other","measure":"Safety","time_frame":"9 Months","description":"Adverse events (AE's), including serious adverse events (SAEs) occurring at any time during the trial and follow-up"}]}
{"nct_id":"NCT02370199","start_date":"2014-11-30","phase":"N/A","enrollment":40,"brief_title":"Peripheral Blood Flow Responses to Electromagnetic Energy","official_title":"Peripheral Blood Flow Responses to Electromagnetic Energy","primary_completion_date":"2025-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2025-12-31","last_update":"2021-05-10","description":"This study evaluates 670 nm energy in the form of red light to stimulate blood flow changes in healthy adults. All participants will receive red light to their leg. They will also receive a continuous infusion of Definity (octafluoropropane) ultrasound contrast.","other_id":"22652","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":59,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Participants will be healthy subjects over the age of 18.\r\n\r\n          -  Men and women will be recruited for participation.\r\n\r\n          -  All ethnicities will be included in this study.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Exclusionary criteria include:\r\n\r\n          -  age under 18 years and those over 60 years of age,\r\n\r\n          -  those who are unable to understand the consent process,\r\n\r\n          -  those who cannot read or speak English,\r\n\r\n          -  a history of cancer,\r\n\r\n          -  peripheral artery disease,\r\n\r\n          -  diabetes mellitus,\r\n\r\n          -  active pregnancy,\r\n\r\n          -  hypersensitivity to perflutren contrast agents,\r\n\r\n          -  pulmonary hypertension,\r\n\r\n          -  chronic kidney disease,\r\n\r\n          -  active tobacco or drug use,\r\n\r\n          -  blood pressure over 160/90, BMI>30,\r\n\r\n          -  sickle cell disease, or\r\n\r\n          -  history of intracardiac shunt.\r\n\r\n        Additional exclusion criteria include:\r\n\r\n          -  a history of coronary artery disease,\r\n\r\n          -  heart failure,\r\n\r\n          -  the presence of an implanted defibrillator or pacemaker,\r\n\r\n          -  a history of heart murmur or rhythm disorder (atrial fibrillation, atrial tachycardia,\r\n             or ventricular tachycardia),\r\n\r\n          -  neurological diseases such as stroke, and\r\n\r\n          -  any uncontrolled medical conditions.\r\n      ","sponsor":"Medical College of Wisconsin","sponsor_type":"Other","conditions":"Exposure to Man-made Visible Light","interventions":[{"intervention_type":"Device","name":"Device: 670 nm light","description":"670 nm light emitting diode will be placed 1 cm above the gastrocnemius muscle. The diode will not be in direct contact with the skin. Subjects will be exposed to 75 mW/cm2."},{"intervention_type":"Drug","name":"Drug: octafluropropane","description":"Octofluoropropane will be administered as a continuous infusion prior to the initiation of 670 nm light in order to measure skeletal muscle blood flow."}],"outcomes":[{"outcome_type":"primary","measure":"Change in blood flow (using octafluoropropane infusion and ultrasound)","time_frame":"10 minutes","description":"Blood flow changes based on ultrasound imaging"}]}
{"nct_id":"NCT02239406","start_date":"2014-11-30","enrollment":7,"brief_title":"Acetabular Bone Vascularity in Metal-on-Metal Revisions","official_title":"Acetabular Bone Vascularity in Metal-on-Metal Revisions","primary_completion_date":"2016-04-30","study_type":"Observational","rec_status":"Terminated","completion_date":"2016-04-30","last_update":"2016-07-22","description":"The purpose of this study is to determine if avascular necrosis of the acetabulum is present in metal-on-metal revisions and to what depth this dead avascular bone occurs. A convenient sample of a consecutive series of 15 patients treated for metal on metal acetabular revision surgery will be included.","other_id":"HK025","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"A convenience sample of a total of 15 patients will be enrolled at OrthoCarolina.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients being revised for an aseptic metal on metal acetabular revision.\r\n\r\n          -  Patient is greater than one year postoperative.\r\n\r\n          -  Patient has had cobalt and chromium metal ion levels tested within 6 months of the\r\n             planned revision surgery.\r\n\r\n          -  Understands the local language and is willing and able to follow the requirements of\r\n             the protocol.\r\n\r\n          -  Understands the informed consent and signs the institutional review board or\r\n             independent ethics committee (IRB/IEC) approved informed consent form.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of infection\r\n\r\n          -  Evidence of current substance or alcohol abuse\r\n\r\n          -  Being treated with radiation, chemotherapy, immunosupression, or chronic steroid\r\n             therapy (prednisone use up to 5 mg/qd or its equivalent is allowed)\r\n\r\n          -  Is a prisoner\r\n      ","sponsor":"OrthoCarolina Research Institute, Inc.","sponsor_type":"Other","conditions":"Failure of Total Hip","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"The depth (mm) of avascular bone from the acetabular surface per each patient","time_frame":"participants will be followed for the duration of their surgery, an expected average of 2 hours","description":"A bone biopsy is a procedure in which bone samples are removed (with a special instrument during surgery) and looked at under a microscope for necrosis (tissue death), infection, or other bone disorders. Once the acetabular hip replacement implants have been removed the following steps will occur:\r\nThe biopsy needle will be inserted into the bone (3 locations; 2 from ilium, 1 from pubis or ischium = 3 total).\r\nThe biopsy needle will be withdrawn and firm pressure will be applied to the biopsy site for a few minutes, until the bleeding has stopped.\r\nEach bone biopsy sample will be labeled sequentially and by anatomic location (i.e., ilium #1, ilium #2)\r\nThe normal bone will be marked on the bone sample.\r\nThe bone biopsy sample will be sent to the lab for examination."},{"outcome_type":"secondary","measure":"The ratio of necrotic bone per each patient","time_frame":"paricipants will be followed for the duration of their surgery, an expected average of 2 hours","description":"The ratio of each bone type (necrotic, acute inflammation, chronic inflammation, and normal bone) in relation to the length of the entire bone specimen will be measured."}]}
{"nct_id":"NCT03027817","start_date":"2014-11-30","enrollment":30,"brief_title":"Cardiac Output and Other Hemodynamic Changes With Prone Position in Cervical Myelopathy Patients Undergoing Surgery","official_title":"Cardiac Output and Other Hemodynamic Changes With Prone Position in Cervical Myelopathy Patients Undergoing Surgery","primary_completion_date":"2015-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2015-12-31","last_update":"2017-01-23","description":"Positioning a patient in prone position under anaesthesia significantly alters cardiovascular physiology. Cervical myelopathy patients are known to have autonomic dysfunction. Such patients when positioned in prone position under anaesthesia carry a higher risk of developing hemodynamic changes and this can compromise spinal cord perfusion. This prospective observational study was conducted on 30 patients with cervical myelopathy who underwent surgery in prone position at NIMHANS, Bangalore hospital. The non invasive cardiac output monitor (NICOM, Cheetah Medicals) was used to record various hemodynamic parameters. The hemodynamic parameters were recorded at baseline, post induction, post intubation, prior to prone position, post prone position, and every five minutes thereafter upto 20mins. The hemodynamic parameters that were recorded using the NICOM monitor: - HR - Heart rate (beats /min) - NIBP - non invasive blood pressure (mmHg) - MAP - mean arterial pressure(mmHg) - CO - cardiac output (l/min) - CI - cardiac index (l/min/m2) - SV - Stroke volume (ml/beat) - SVV -stroke volume variability (%) - TPR - total peripheral resistance (dynes. sec/cm5)","other_id":"NIMHANS","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":65,"population":"Patients with Cervical Myelopathy undergoing elective cervical decompression in prone\r\n        position.","criteria":"\n        Inclusion Criteria:\r\n\r\n        Cervical myelopathy patients undergoing surgery in prone position with:\r\n\r\n          -  ASA Class I , II and III\r\n\r\n          -  Age between 18 to 65 years\r\n\r\n          -  Nurick's grade 2 or more\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Atlanto occipital dislocation and cervicomedullary junction pathology\r\n\r\n          -  Tumour pathology\r\n\r\n          -  Diabetic patients\r\n\r\n          -  Patients positioned prone in the awake state (without induction of anaesthesia)\r\n      ","sponsor":"Dhritiman Chakrabarti","sponsor_type":"Other","conditions":"Hemodynamics Instability","interventions":[{"intervention_type":"Procedure","name":"Procedure: Prone Positioning","description":"Noninvasive cardiac output monitoring parameters were recorded before and after prone positioning."}],"outcomes":[{"outcome_type":"primary","measure":"Mean arterial pressure","time_frame":"Before induction of anaesthesia to 20 minutes after prone positioning (end of study)","description":"Analysis of change in mean arterial pressure at following time points - before induction of anaesthesia, 2 minutes after anaesthetic induction, 2 minutes after intubation, before turning prone, immediately after turning prone and every 5 minutes thereafter till 20 minutes after positioning."},{"outcome_type":"secondary","measure":"Heart rate","time_frame":"Before induction of anaesthesia to 20 minutes after prone positioning (end of study)","description":"Analysis of change in heart rate at following time points - before induction of anaesthesia, 2 minutes after anaesthetic induction, 2 minutes after intubation, before turning prone, immediately after turning prone and every 5 minutes thereafter till 20 minutes after positioning."},{"outcome_type":"secondary","measure":"Cardiac output","time_frame":"Before induction of anaesthesia to 20 minutes after prone positioning (end of study)","description":"Analysis of change in cardiac output at following time points - before induction of anaesthesia, 2 minutes after anaesthetic induction, 2 minutes after intubation, before turning prone, immediately after turning prone and every 5 minutes thereafter till 20 minutes after positioning."},{"outcome_type":"secondary","measure":"Stroke volume","time_frame":"Before induction of anaesthesia to 20 minutes after prone positioning (end of study)","description":"Analysis of change in stroke volume at following time points - before induction of anaesthesia, 2 minutes after anaesthetic induction, 2 minutes after intubation, before turning prone, immediately after turning prone and every 5 minutes thereafter till 20 minutes after positioning."},{"outcome_type":"secondary","measure":"Stroke volume variation","time_frame":"Before induction of anaesthesia to 20 minutes after prone positioning (end of study)","description":"Analysis of change in stroke volume variation at following time points - before induction of anaesthesia, 2 minutes after anaesthetic induction, 2 minutes after intubation, before turning prone, immediately after turning prone and every 5 minutes thereafter till 20 minutes after positioning."},{"outcome_type":"secondary","measure":"Total peripheral resistance","time_frame":"Before induction of anaesthesia to 20 minutes after prone positioning (end of study)","description":"Analysis of change in total peripheral resistance at following time points - before induction of anaesthesia, 2 minutes after anaesthetic induction, 2 minutes after intubation, before turning prone, immediately after turning prone and every 5 minutes thereafter till 20 minutes after positioning."}]}
{"nct_id":"NCT02169310","start_date":"2014-11-18","enrollment":45,"brief_title":"Neural Basis of Decision-Making Deficits in Traumatic Brain Injury","official_title":"Neural Basis of Decision Making Deficits in Traumatic Brain Injury","primary_completion_date":"2022-09-01","study_type":"Observational","rec_status":"Suspended","completion_date":"2023-09-01","last_update":"2021-08-19","description":"Background: - People with a traumatic brain injury (TBI) can have trouble making the best possible decisions. Researchers want to learn more about the parts of the brain that control decision making. They also want to know how these are different between people. This may help predict how people make decisions after TBI. Objective: - To learn more about which parts of the brain are involved in making decisions and how decisions may be hurt after TBI. Eligibility: - Adults age 18 to 60. Design: - Participants will be screened with medical history and physical exam. They will also take memory, attention, concentration, and thinking tests. - Participants will do up to 2 experiments. - For Experiment 1, participants may have 3 scans: - PET: a chemical is injected through a thin tube into an arm vein. Participants lie on a bed that slides in and out of the scanner. - MRI: a strong magnetic field and radio waves take pictures of the brain. Participants lie on a table that slides in and out of a metal cylinder. It makes loud knocking noises. Participants will get earplugs. They might be asked to do a task. A coil will be placed over the head. - MEG: a cone with magnetic field detectors is lowered onto participants head. - After the scans, participants will perform a decision-making task. - For Experiment 2, participants will perform a decision-making task before and after receiving transcranial direct current stimulation (tDCS). - tDCS: wet electrode sponges are placed over participants scalp and forehead. A current passes between the electrodes. It stimulating the brain. - Participants will return 24-48 hours later to repeat the decision-making task.","other_id":"140083","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":60,"population":"Up to 40 adult healthy volunteers between the ages of 18 and 60 and 40 adult TBI patients\r\n        between the ages of 18 and sixty will be recruited under this protocol. The target number\r\n        of completers will be approximately 30 adult healthy volunteers and 30 adult TBI patients\r\n        (we expect approximately 10 individuals in each group to have no data or incomplete data,\r\n        due to screening failures, dropouts, or technical difficulties). Any participants withdrawn\r\n        from the study or whose data is excluded will be replaced up to the approved accrual limit.","criteria":"\n        -  INCLUSION CRITERIA\r\n\r\n          -  Age 18 to 60\r\n\r\n          -  Able to give consent\r\n\r\n          -  Must be able to follow instructions and perform required tasks\r\n\r\n          -  For healthy volunteers, absence of clinically significant abnormalities during\r\n\r\n        neurological examination\r\n\r\n        Additional Inclusion Criteria for TBI:\r\n\r\n        -History of having a sustained, traumatically induced (e.g., collision between the head and\r\n        an object, or sudden acceleration/deceleration of the brain without direct\r\n\r\n        external trauma to the head) physiological disruption of brain function, as manifested by\r\n        at least one of the following (based on the American Congress of Rehabilitation Medicine\r\n        Criteria):\r\n\r\n          -  Any period of loss of consciousness\r\n\r\n          -  Any loss of memory for events immediately before or after the accident\r\n\r\n          -  Focal neurological deficit(s) that may or may not be transient\r\n\r\n          -  Any alteration in mental state at the time of the accident (e.g., feeling dazed,\r\n             disoriented, or confused)\r\n\r\n          -  Presentation to an Emergency Department within 24 hours of the injury event\r\n\r\n          -  History of self-reported complaints or clinical findings related to planning or\r\n             decision-making deficits\r\n\r\n        EXCLUSION CRITERIA\r\n\r\n          -  Pre-existing and disabling major psychiatric (e.g., schizophrenia, bipolar disorder or\r\n             post-traumatic stress disorder) or neurological disease (e.g., stroke, dementia,\r\n             epilepsy, or multiple sclerosis).\r\n\r\n          -  Present use of prescribed stimulants (e.g., methylphenidate or amphetamines)\r\n\r\n          -  Present use of prescribed dopamine agonists/antagonists other than amantadine\r\n\r\n          -  For female participants, pregnancy (for MRI and PET procedures) or nursing (for PET\r\n             procedures only)\r\n\r\n          -  Contraindication to PET procedures (for PET procedures only)\r\n\r\n          -  Contraindication to MRI procedures as per MRI Center screening questionnaire (for MRI\r\n             procedures only)\r\n\r\n          -  Inability to participate in at least two of the imaging procedures (PET, MRI or MEG)\r\n             due to contraindications\r\n\r\n          -  Staff from our section\r\n\r\n          -  For TBI patients, history of a penetrating head wound\r\n\r\n          -  For healthy volunteers, history of any type of traumatically induced head injury\r\n             resulting in presentation to an Emergency Department within 24 hours of the injury\r\n             event\r\n      ","sponsor":"National Institute of Neurological Disorders and Stroke (NINDS)","sponsor_type":"NIH","conditions":"Traumatic Brain Injury","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Performance in decision-making task","time_frame":"Experiment 1 - The outcome measure is assessed after all neuroimaging procedures are completed.","description":"We fit an optimal Markov decision process model to the task and compare model parameters to the decision-making behavior observed in individual subjects."},{"outcome_type":"primary","measure":"Performance in decision-making task for Experiment 2","time_frame":"Experiment 2 - The outcome measure is assessed at three timepoints. Immediately prior to and after application of real or sham tDCS on Visit 1, and 24-48 hours later on Visit 2.","description":"We fit an optimal Markov decision process model to the task and compare model parameters to the decision- making behavior observed in individual subjects."}]}
{"nct_id":"NCT02229851","start_date":"2014-10-31","phase":"Phase 3","enrollment":301,"brief_title":"Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin FlexPro (Somatropin) in Adults With Growth Hormone Deficiency.","official_title":"A Multicentre, Multinational, Randomised, Parallel-group, Placebo-controlled (Double Blind) and Active-controlled (Open) Trial to Compare the Efficacy and Safety of Once Weekly Dosing of NNC0195-0092 (Somapacitan) With Once Weekly Dosing of Placebo and Daily Norditropin FlexPro in Adults With Growth Hormone Deficiency for 35 Weeks, Followed by a 53-week Open-label Extension Period","primary_completion_date":"2017-04-21","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-05-07","last_update":"2020-11-23","description":"This study is conducted globally. The purpose is to demonstrate the efficacy of once weekly dosing of NNC0195-0092 (somapacitan) compared to placebo and once-daily dosing of somatropin (human growth hormone, hGH) after 35 weeks of treatment in adults with growth hormone deficiency.","other_id":"NN8640-4054","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":23,"maximum_age":79,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female of at least 23 years of age and not more than 79 years of age at the\r\n             time of signing informed consent\r\n\r\n          -  Human growth hormone (hGH) treatment nave or no exposure to hGH or growth hormone\r\n             (GH) secretagogues for at least 180 days prior to randomisation with any registered or\r\n             investigational hGH or GH secretagogue product (if only used in connection with\r\n             stimulation tests for diagnosis of growth hormone deficiency (GHD), subjects can be\r\n             included)\r\n\r\n          -  If applicable, hormone replacement therapies for any other hormone deficiencies,\r\n             adequate and stable for at least 90 days prior to randomisation as judged by the\r\n             investigator\r\n\r\n          -  FOR ALL COUNTRIES EXCEPT JAPAN:\r\n\r\n        Confirmed diagnosis of adult growth hormone deficiency (Subjects must satisfy one of the\r\n        following criterion and documentation of test results must be available before\r\n        randomisation (either from subjects' file or new test):\r\n\r\n          1. Insulin tolerance test (ITT) or glucagon test: a peak GH response of less than 3 ng/mL\r\n             (3 mcg/L)\r\n\r\n          2. Growth hormone releasing hormone (GHRH) + arginine test according to body mass index\r\n             (BMI): i) BMI less than 25 kg/m^2, a peak GH less than 11 ng/mL (11 mcg/L), ii) BMI\r\n             25-30 kg/m^2, a peak GH less than 8 ng/mL (8 mcg/L), iii) BMI greater than 30 kg/m^2,\r\n             a peak GH less than 4 ng/mL (4 mcg/L)\r\n\r\n          3. Three or more pituitary hormone deficiencies and insulin like growth factor - I\r\n             standard deviation score (IGF-I SDS) less than -2.0 - FOR JAPAN ONLY: Confirmed\r\n             diagnosis of adult growth hormone deficiency (subjects with adult onset adult growth\r\n             hormone deficiency (AGHD) need to satisfy at least one of the following criteria,\r\n             subjects with a history of childhood GHD need to satisfy at least 2 of the following\r\n             criteria):\r\n\r\n        a. ITT test: a peak GH of less than or equal to 1.8 ng/mL (assay using recombinant GH\r\n        standard) b. glucagon test: a peak GH of less than or equal to 1.8 ng/mL (assay using\r\n        recombinant GH standard) c. growth hormone releasing peptide 2 (GHRP-2) tolerance test: a\r\n        peak GH of less than or equal to 9 ng/mL (assay using recombinant GH standard)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Active malignant disease or history of malignancy. Exceptions to this exclusion\r\n             criterion: - Resection in situ carcinoma of the cervix uteri. Complete eradication of\r\n             squamous cell or basal cell carcinoma of the skin\r\n\r\n          -  Subjects with GHD attributed to treatment of intracranial malignant tumours or\r\n             leukaemia, provided that a recurrence-free survival period of at least 5 years is\r\n             documented in the subject's file\r\n      ","sponsor":"Novo Nordisk A/S","sponsor_type":"Industry","conditions":"Growth Hormone Disorder|Adult Growth Hormone Deficiency","interventions":[{"intervention_type":"Drug","name":"Drug: somapacitan","description":"Administered subcutaneously (s.c., under the skin) once weekly for 26 weeks following 8 weeks of titration. Extension of 44 weeks' treatment following 8 weeks of titration."},{"intervention_type":"Drug","name":"Drug: somatropin","description":"Administered subcutaneously (s.c., under the skin) once daily for 26 weeks following 8 weeks of titration. Re-randomisation to extension of 44 weeks' treatment following 8 weeks of titration."},{"intervention_type":"Drug","name":"Drug: placebo","description":"Administered subcutaneously (s.c., under the skin) once weekly for 26 weeks following 8 weeks of titration."}],"outcomes":[{"outcome_type":"secondary","measure":"Change in IL-6 (Week 87)","time_frame":"week -3, week 87","description":"Change in IL-6 was measured from baseline (week -3) until the end of the extension treatment period (week 87)."},{"outcome_type":"secondary","measure":"Change in Body Weight (Week 34)","time_frame":"Week -3, week 34","description":"Change in body weight was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Bilirubin (Week 87)","time_frame":"week -3, week 87","description":"Change in Bilirubin was measured from baseline (week -3) until the end of the extension treatment period (week 87)."},{"outcome_type":"secondary","measure":"Change in Body Weight (Week 87)","time_frame":"week -3, week 87","description":"Change in body weight was measured from baseline (week -3) until the end of the extension treatment period (week 87)."},{"outcome_type":"secondary","measure":"Change in Calcium (Week 34)","time_frame":"Week -3, week 34","description":"Change in Calcium was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Waist Circumference (Week 34)","time_frame":"Week -3, week 34","description":"Change in waist circumference was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-35)","time_frame":"Weeks 0 to 35","description":"Number of participants with anti-NNC0195-0092 antibodies at week 35 was recorded. The numbers presented in this endpoint are the participants that were found to have positive antibodies."},{"outcome_type":"secondary","measure":"Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-88)","time_frame":"Weeks 0 to 88","description":"Number of participants with anti-NNC0195-0092 antibodies at week 88 was recorded. The numbers presented in this endpoint are the participants that were found to have positive antibodies."},{"outcome_type":"primary","measure":"Change in Truncal Fat Percentage (Week 34)","time_frame":"Week -3, week 34","description":"Change in Truncal fat percentage was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Truncal Fat Percentage (Week 87)","time_frame":"week -3, week 87","description":"Change in Truncal fat percentage was measured from baseline (week -3) until the end of the extension treatment period (week 87)."},{"outcome_type":"secondary","measure":"Change in Truncal Fat Mass (Week 34)","time_frame":"Week -3, week 34","description":"Change in Truncal fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Truncal Fat Mass (Week 87)","time_frame":"week -3, week 87","description":"Change in Truncal fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87)."},{"outcome_type":"secondary","measure":"Change in Truncal Lean Body Mass (Week 34)","time_frame":"Week -3, week 34","description":"Change in Truncal lean body mass was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Truncal Lean Body Mass (Week 87)","time_frame":"week -3, week 87","description":"Change in Truncal lean body mass was measured from baseline (week -3) until the end of the extension treatment period (week 87)."},{"outcome_type":"secondary","measure":"Change in Total Fat Mass (Week 34)","time_frame":"Week -3, week 34","description":"Change in Total fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Total Fat Mass (Week 87)","time_frame":"Week -3, week 87","description":"Change in total fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87)."},{"outcome_type":"secondary","measure":"Change in Visceral Adipose Tissue (Week 34)","time_frame":"Week -3, week 34","description":"Change in Visceral adipose tissue was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Visceral Adipose Tissue (Week 87)","time_frame":"Week -3, week 87","description":"Change in Visceral adipose tissue was measured from baseline (week -3) until the end of the extension treatment period (week 87)."},{"outcome_type":"secondary","measure":"Change in Android Fat Mass (Week 34)","time_frame":"Week -3, week 34","description":"Change in Android fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Android Fat Mass (Week 87)","time_frame":"week -3, week 87","description":"Change in Android fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87)."},{"outcome_type":"secondary","measure":"Change in Gynoid Fat Mass (Week 34)","time_frame":"Week -3, week 34","description":"Change in Gynoid fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Gynoid Fat Mass (Week 87)","time_frame":"week -3, week 87","description":"Change in Gynoid fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87)."},{"outcome_type":"secondary","measure":"Change in Appendicular Skeletal Muscle Mass (Week 34)","time_frame":"Week -3, week 34","description":"Change in Appendicular skeletal muscle mass was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Appendicular Skeletal Muscle Mass (Week 87)","time_frame":"week -3, week 87","description":"Change in Appendicular skeletal muscle mass was measured from baseline (week -3) until the end of the extension treatment period (week 87)."},{"outcome_type":"secondary","measure":"Change in Lean Body Mass (Week 34)","time_frame":"Week -3, week 34","description":"Change in Lean body mass was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Lean Body Mass (Week 87)","time_frame":"week -3, week 87","description":"Change in Lean body mass was measured from baseline (week -3) until the end of the extension treatment period (week 87)."},{"outcome_type":"secondary","measure":"Change in Bone Mineral Content (Week 87)","time_frame":"week -3, week 87","description":"Change in Bone mineral content was measured from baseline (week -3) until the end of the extension treatment period (week 87)."},{"outcome_type":"secondary","measure":"Change in Bone Mineral Density (Week 87)","time_frame":"week -3, week 87","description":"Change in Bone mineral density was measured from baseline (week -3) until the end of the extension treatment period (week 87)."},{"outcome_type":"secondary","measure":"Change in IGF-I SDS (Week 34)","time_frame":"Week -3, week 34","description":"Change in insulin-like growth factor (IGF-I) standard deviation scores (SDS) was measured from baseline (week -3) until the end of the main treatment period (week 34). A higher score reflects a better outcome."},{"outcome_type":"secondary","measure":"Change in IGF-I SDS (Week 87)","time_frame":"Week -3, week 87","description":"Change in IGF-I SDS was measured from baseline (week -3) until the end of the extension treatment period (week 87). A higher score reflects a better outcome."},{"outcome_type":"secondary","measure":"Change in IGFBP 3 SDS (Week 34)","time_frame":"Week -3, week 34","description":"Change in insulin like growth factor binding protein 3 (IGFBP 3) SDS was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in IGFBP 3 SDS (Week 87)","time_frame":"Week -3, week 87","description":"Change in IGFBP 3 SDS was measured from baseline (week -3) until the end of the extension treatment period (week 87)."},{"outcome_type":"secondary","measure":"Change in TRIM-AGHD (Total and Domain Scores) (Week 34)","time_frame":"Week 0, week 34","description":"Change in treatment-related impact measure - adult growth hormone deficiency (TRIM-AGHD) scores (total and domain scores) was measured from baseline (week 0) until the end of the main treatment period (week 34). The TRIM-AGHD questionnaire measured the impact of GH treatment on the functioning and well-being of AGHD patients. The 4 concepts covered by the questionnaire were physical health, energy levels, cognitive ability and psychological health. TRIM-AGHD has 27 items and a total score as well as domain specific scores can be derived. The total score includes all answers that has been used to calculate each of the 4 subdomains. The score ranged from 0 to 100 for 'individual domains' and for the 'total', where a lower score reflected a better outcome."},{"outcome_type":"secondary","measure":"Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-35)","time_frame":"Weeks 0 to 35","description":"Incidence of technical complaints were recorded from baseline (week 0) until week 35."},{"outcome_type":"secondary","measure":"Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-88)","time_frame":"Weeks 0 to 88","description":"Incidence of technical complaints were recorded from baseline (week 0) until week 88."},{"outcome_type":"secondary","measure":"Change in TRIM-AGHD (Total and Domain Scores) (Week 87)","time_frame":"week 0, week 87","description":"Change in TRIM-AGHD (total and domain scores) was measured from baseline (week 0) until the end of the extension treatment period (week 87). The TRIM-AGHD questionnaire measured the impact of GH treatment on the functioning and well-being of AGHD patients. The 4 concepts covered by the questionnaire were physical health, energy levels, cognitive ability and psychological health. TRIM-AGHD has 27 items and a total score as well as domain specific scores can be derived. The total score includes all answers that has been used to calculate each of the 4 subdomains. The score ranged from 0 to 100 for 'individual domains' and for the 'total', where a lower score reflected a better outcome."},{"outcome_type":"secondary","measure":"Change in SF-36v2 (Summary and Domain Scores) (Week 34)","time_frame":"Week 0, week 34","description":"SF-36v2™ questionnaire measured health-related quality of life (HRQoL) on 8 domains (Bodily Pain, General Health, Mental Health, Physical Functioning, Role Emotion, Physical Health, Social Functioning and Vitality) on individual scale ranges. The scores 0-100 (higher scores indicates better HRQoL) from SF-36 were converted to norm-based scores to enable a direct interpretation in relation to distribution of the scores in the 2009 U.S. general population. Mental component summary (MCS) measure is derived from domain scales of vitality, social functioning, role emotional and mental health. Physical component summary (PCS) measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline."},{"outcome_type":"secondary","measure":"Change in SF-36v2 (Summary and Domain Scores) (Week 87)","time_frame":"week 0, week 87","description":"SF-36v2™ questionnaire measured health-related quality of life (HRQoL) on 8 domains (Bodily Pain, General Health, Mental Health, Physical Functioning, Role Emotion, Physical Health, Social Functioning and Vitality) on individual scale ranges. The scores 0-100 (higher scores indicates better HRQoL) from SF-36 were converted to norm-based scores to enable a direct interpretation in relation to distribution of the scores in the 2009 U.S. general population. Mental component summary (MCS) measure is derived from domain scales of vitality, social functioning, role emotional and mental health. Physical component summary (PCS) measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline."},{"outcome_type":"secondary","measure":"TSQM-9 Scores (Domain Scores) (Week 34)","time_frame":"Week 34","description":"Scores from the TSQM-9 scale were calculated at the end of the main treatment period (week 34). The Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9) is a generic questionnaire that measures a patients' satisfaction with medication. Items are rated on a 5-point or 7-point scale according to patients' experience with the medication. The items covered are satisfaction with the effect of the medication, convenience and global treatment satisfaction. Each domain is based on 3 questions. The score is calculated in a range from 0 to 100, where a higher score reflects a better outcome. Scores have been summed and then scaled to 0-100."},{"outcome_type":"secondary","measure":"TSQM-9 Scores (Domain Scores) (Week 87)","time_frame":"Week 87","description":"Scores from the TSQM-9 scale were calculated at the end of the extension treatment period (week 87). The Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9) is a generic questionnaire that measures a patients' satisfaction with medication. Items are rated on a 5-point or 7-point scale according to patients' experience with the medication. The items covered are satisfaction with the effect of the medication, convenience and global treatment satisfaction. Each domain is based on 3 questions. The score is calculated in a range from 0 to 100, where a higher score reflects a better outcome. Scores have been summed and then scaled to 0-100."},{"outcome_type":"secondary","measure":"Change in Total Cholesterol (Week 34)","time_frame":"Week -3, week 34","description":"Change in Total cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Total Cholesterol (Week 87)","time_frame":"week -3, week 87","description":"Change in Total cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87)."},{"outcome_type":"secondary","measure":"Change in HDL-cholesterol (Week 34)","time_frame":"Week -3, week 34","description":"Change in High-density lipoprotein (HDL) cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in HDL-cholesterol (Week 87)","time_frame":"week -3, week 87","description":"Change in HDL-cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87)."},{"outcome_type":"secondary","measure":"Change in LDL-cholesterol (Week 34)","time_frame":"Week -3, week 34","description":"Change in Low-density lipoprotein (LDL) cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in LDL-cholesterol (Week 87)","time_frame":"week -3, week 87","description":"Change in LDL-cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87)."},{"outcome_type":"secondary","measure":"Change in Triglycerides (Week 34)","time_frame":"Week -3, week 34","description":"Change in Triglycerides was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Triglycerides (Week 87)","time_frame":"week -3, week 87","description":"Change in Triglycerides was measured from baseline (week -3) until the end of the extension treatment period (week 87)."},{"outcome_type":"secondary","measure":"Change in Hs-CRP (Week 34)","time_frame":"Week -3, week 34","description":"Change in high-sensitivity C-reactive protein (hs-CRP) was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Hs-CRP (Week 87)","time_frame":"week -3, week 87","description":"Change in hs-CRP was measured from baseline (week -3) until the end of the extension treatment period (week 87)."},{"outcome_type":"secondary","measure":"Change in IL-6 (Week 34)","time_frame":"Week -3, week 34","description":"Change in Interleukin 6 (IL-6) was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Waist Circumference (Week 87)","time_frame":"week -3, week 87","description":"Change in waist circumference was measured from baseline (week -3) until the end of the extension treatment period (week 87)."},{"outcome_type":"secondary","measure":"Number of Adverse Events (Weeks 0-35)","time_frame":"Weeks 0-35","description":"Number of adverse events from baseline (week 0) until the end of week 35 were reported. This endpoint shows number of treatment-emergent adverse events (TEAEs), including the injection site reactions."},{"outcome_type":"secondary","measure":"Number of Adverse Events (Weeks 0-88)","time_frame":"Weeks 0-88","description":"Number of adverse events from baseline (week 0) until the end of week 88 were reported. This endpoint shows the number of TEAEs along with the injection site reactions."},{"outcome_type":"secondary","measure":"Change in Physical Examination During Exposure to Trial Product (Week 35)","time_frame":"Week 0 and week 35","description":"Change in physical examination from baseline (week 0) until the end of the main treatment period (week 35) was reported. Results are presented for the following examinations: 1) Head, neck, eyes and nose 2) Respiratory system (sys.) 3) Cardiovascular sys. 4) Gastrointestinal sys. 5) Musculoskeletal sys. 6) Central & Peripheral nervous sys. 7) Skin 8) Lymph node palpation"},{"outcome_type":"secondary","measure":"Change in Physical Examination During Exposure to Trial Product (Week 88)","time_frame":"Week 0 and week 88","description":"Change in physical examination from baseline (week 0) until the end of the extension period (week 88) was reported. Results are presented for the following examinations: 1) Head, neck, eyes and nose 2) Respiratory system (sys.) 3) Cardiovascular sys. 4) Gastrointestinal sys. 5) Musculoskeletal sys. 6) Central & Peripheral nervous sys. 7) Skin 8) Lymph node palpation"},{"outcome_type":"secondary","measure":"Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35)","time_frame":"Week -3 and week 35","description":"Change in Electrocardiogram (ECG) evaluation from baseline (week -3) until the end of the main treatment period (week 35) was reported."},{"outcome_type":"secondary","measure":"Change in ECG Evaluation During Exposure to Trial Product (Week 88)","time_frame":"Week -3 and week 88","description":"Change in ECG evaluation from baseline (week 0) until the end of the extension period (Week 88) was reported."},{"outcome_type":"secondary","measure":"Change in Diastolic Blood Pressure (Week 35)","time_frame":"Week -3, week 35","description":"Change in diastolic blood pressure was measured from baseline (week -3) until the end of the main treatment period (week 35)."},{"outcome_type":"secondary","measure":"Change in Diastolic Blood Pressure (Week 88)","time_frame":"Week -3, week 88","description":"Change in diastolic blood pressure was measured from baseline (week -3) until the end of the extension treatment period week 88."},{"outcome_type":"secondary","measure":"Change in Systolic Blood Pressure (Week 35)","time_frame":"Week -3, week 35","description":"Change in systolic blood pressure was measured from baseline (week -3) until the end of the main treatment period (week 35)."},{"outcome_type":"secondary","measure":"Change in Systolic Blood Pressure (Week 88)","time_frame":"Week -3, week 88","description":"Change in systolic blood pressure was measured from baseline (week -3) until the end of the extension treatment period (week 88)."},{"outcome_type":"secondary","measure":"Change in Pulse (Week 35)","time_frame":"Week -3, week 35","description":"Change in pulse was measured from baseline (week -3) until the end of the main treatment period (week 35)."},{"outcome_type":"secondary","measure":"Change in Pulse (Week 88)","time_frame":"Week -3, week 88","description":"Change in pulse was measured from baseline (week -3) until the end of the extension treatment period (week 88)."},{"outcome_type":"secondary","measure":"Change in Haemoglobin (Week 34)","time_frame":"Week -3, week 34","description":"Change in Haemoglobin was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Haemoglobin (Week 87)","time_frame":"week -3, week 87","description":"Change in Haemoglobin was measured from baseline (week -3) until the end of the week 87."},{"outcome_type":"secondary","measure":"Change in Haematocrit (Week 34)","time_frame":"Week -3, week 34","description":"Change in Haematocrit was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Haematocrit (Week 87)","time_frame":"week -3, week 87","description":"Change in Haematocrit was measured from baseline (week -3) until the end of the week 87."},{"outcome_type":"secondary","measure":"Change in Erythrocytes (Week 34)","time_frame":"Week -3, week 34","description":"Change in Erythrocytes was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Erythrocytes (Week 87)","time_frame":"week -3, week 87","description":"Change in Erythrocytes was measured from baseline (week -3) until the end of the week 87."},{"outcome_type":"secondary","measure":"Change in Mean Corpuscular Volume (MCV) (Week 34)","time_frame":"Week -3, week 34","description":"Change in Mean corpuscular volume (MCV) was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Mean Corpuscular Volume (MCV) (Week 87)","time_frame":"week -3, week 87","description":"Change in Mean corpuscular volume (MCV) was measured from baseline (week -3) until the end of the week 87."},{"outcome_type":"secondary","measure":"Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 34)","time_frame":"Week -3, week 34","description":"Change in Mean corpuscular haemoglobin concentration (MCHC) was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 87)","time_frame":"week -3, week 87","description":"Change in Mean corpuscular haemoglobin concentration (MCHC) was measured from baseline (week -3) until the end of the week 87."},{"outcome_type":"secondary","measure":"Change in Thrombocytes (Week 34)","time_frame":"Week -3, week 34","description":"Change in Thrombocytes was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Thrombocytes (Week 87)","time_frame":"week -3, week 87","description":"Change in Thrombocytes was measured from baseline (week -3) until the end of the week 87."},{"outcome_type":"secondary","measure":"Change in Leucocytes (Week 34)","time_frame":"Week -3, week 34","description":"Change in Leucocytes was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Leucocytes (Week 87)","time_frame":"week -3, week 87","description":"Change in Leucocytes was measured from baseline (week -3) until the end of the week 87."},{"outcome_type":"secondary","measure":"Change in Alanine Aminotransferase (ALT) (Week 34)","time_frame":"Week -3, week 34","description":"Change in ALT was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Alanine Aminotransferase (ALT) (Week 87)","time_frame":"week -3, week 87","description":"Change in ALT was measured from baseline (week -3) until the end of the week 87."},{"outcome_type":"secondary","measure":"Change in Albumin (Week 34)","time_frame":"Week -3, week 34","description":"Change in Albumin was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Albumin (Week 87)","time_frame":"week -3, week 87","description":"Change in Albumin was measured from baseline (week -3) until the end of the week 87."},{"outcome_type":"secondary","measure":"Change in Alkaline Phosphatase (ALP) (Week 34)","time_frame":"Week -3, week 34","description":"Change in Alkaline phosphatase (ALP) was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Alkaline Phosphatase (AP) (Week 87)","time_frame":"Week -3, week 87","description":"Change in Alkaline phosphatase (AP) was measured from baseline (week -3) until the end of the week 87."},{"outcome_type":"secondary","measure":"Change in Aspartate Aminotransferase (AST) (Week 34)","time_frame":"Week -3, week 34","description":"Change in AST was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Aspartate Aminotransferase (AST) (Week 87)","time_frame":"Week -3, week 87","description":"Change in AST was measured from baseline (week -3) until the end of the extension treatment period (week 87)."},{"outcome_type":"secondary","measure":"Change in Bilirubin (Week 34)","time_frame":"Week -3, week 34","description":"Change in Bilirubin was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Calcium (Week 87)","time_frame":"week -3, week 87","description":"Change in Calcium was measured from baseline (week -3) until the end of the week 87."},{"outcome_type":"secondary","measure":"Change in Chloride (Week 34)","time_frame":"Week -3, week 34","description":"Change in Chloride was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Chloride (Week 87)","time_frame":"week -3, week 87","description":"Change in Chloride was measured from baseline (week -3) until the end of the week 87."},{"outcome_type":"secondary","measure":"Change in Creatinine (Week 34)","time_frame":"Week -3, week 34","description":"Change in Creatinine was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Creatinine (Week 87)","time_frame":"week -3, week 87","description":"Change in Creatinine was measured from baseline (week -3) until the end of the week 87."},{"outcome_type":"secondary","measure":"Change in Creatine Kinase (Week 34)","time_frame":"Week -3, week 34","description":"Change in Creatine kinase was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Creatine Kinase (Week 87)","time_frame":"week -3, week 87","description":"Change in Creatine kinase was measured from baseline (week -3) until the end of the week 87."},{"outcome_type":"secondary","measure":"Change in Gamma-glutamyl Transferase (GGT) (Week 34)","time_frame":"Week -3, week 34","description":"Change in GGT was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Gamma-glutamyl Transferase (GGT) (Week 87)","time_frame":"week -3, week 87","description":"Change in GGT was measured from baseline (week -3) until the end of the week 87."},{"outcome_type":"secondary","measure":"Change in Phosphate (Inorganic) (Week 34)","time_frame":"Week -3, week 34","description":"Change in Phosphate (inorganic) was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Phosphate (Inorganic)(Week 87)","time_frame":"week -3, week 87","description":"Change in Phosphate (inorganic) was measured from baseline (week -3) until the end of the week 87."},{"outcome_type":"secondary","measure":"Change in Potassium (Week 34)","time_frame":"Week -3, week 34","description":"Change in Potassium was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Potassium (Week 87)","time_frame":"week -3, week 87","description":"Change in Potassium was measured from baseline (week -3) until the end of the week 87."},{"outcome_type":"secondary","measure":"Change in Sodium (Week 34)","time_frame":"Week -3, week 34","description":"Change in Sodium was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Sodium (Week 87)","time_frame":"week -3, week 87","description":"Change in Sodium was measured from baseline (week -3) until the end of the extension treatment period (week 87)."},{"outcome_type":"secondary","measure":"Change in Total Protein (Week 34)","time_frame":"Week -3, week 34","description":"Change in total protein was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Total Protein (Week 87)","time_frame":"week -3, week 87","description":"Change in total protein was measured from baseline (week -3) until the end of extension treatment period (week 87)."},{"outcome_type":"secondary","measure":"Change in Urea (Week 34)","time_frame":"Week -3, week 34","description":"Change in Urea was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Urea (Week 87)","time_frame":"week -3, week 87","description":"Change in Urea was measured from baseline (week -3) until the end of the extension treatment period (week 87)."},{"outcome_type":"secondary","measure":"Change in Uric Acid (Week 34)","time_frame":"Week -3, week 34","description":"Change in Uric acid was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Uric Acid (Week 87)","time_frame":"week -3, week 87","description":"Change in Uric acid was measured from baseline (week -3) until the end of the extension treatment period (week 87)."},{"outcome_type":"secondary","measure":"Change in Estimated Glomerular Filtration Rate (GFR) Creatinine (CKD-EPI) (Week 34)","time_frame":"Week -3, week 34","description":"Change in Estimated GFR creatinine (CKD-EPI) was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Estimated GFR Creatinine (CKD-EPI) (Week 87)","time_frame":"week -3, week 87","description":"Change in estimated GFR creatinine (CKD-EPI) was measured from baseline (week -3) until the end of the extension treatment period (week 87)."},{"outcome_type":"secondary","measure":"Change in Fasting Plasma Glucose (Week 34)","time_frame":"Week -3, week 34","description":"Change in Fasting plasma glucosewas measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Fasting Plasma Glucose (Week 87)","time_frame":"week -3, week 87","description":"Change in Fasting plasma glucose was measured from baseline (week -3) until the end of the extension treatment period (week 87)."},{"outcome_type":"secondary","measure":"Change in Fasting Insulin (Week 34)","time_frame":"Week -3, week 34","description":"Change in Fasting insulin was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Fasting Insulin (Week 87)","time_frame":"week -3, week 87","description":"Change in Fasting insulin was measured from baseline (week -3) until the end of the extension treatment period (week 87)."},{"outcome_type":"secondary","measure":"Change in Steady State Beta Cell Function (%B) (Week 34)","time_frame":"Week -3, week 34","description":"Change in steady state beta cell function (%B) was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Steady State Beta Cell Function (%B) (Week 87)","time_frame":"week -3, week 87","description":"Change in steady state beta cell function (%B) was measured from baseline (week -3) until the end of the week 87."},{"outcome_type":"secondary","measure":"Change in Insulin Resistance (IR %) (Week 34)","time_frame":"Week -3, week 34","description":"Change in Insulin resistance (IR %) was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Insulin Resistance (IR %) (Week 87)","time_frame":"week -3, week 87","description":"Change in Insulin resistance (IR %) was measured from baseline (week -3) until the end of the extension treatment period (week 87)."},{"outcome_type":"secondary","measure":"Change in Glycated Haemoglobin (HbA1c) (%) (Week 34)","time_frame":"Week -3, week 34","description":"Change in Glycated haemoglobin (HbA1c) (%) was measured from baseline (week -3) until the end of the main treatment period (week 34)."},{"outcome_type":"secondary","measure":"Change in Glycated Haemoglobin (HbA1c) (%) (Week 87)","time_frame":"week -3, week 87","description":"Change in Glycated haemoglobin (HbA1c) was measured from baseline (week -3) until the end of the extension treatment period (week 87)."}]}
{"nct_id":"NCT02179554","start_date":"2014-10-31","enrollment":0,"brief_title":"Does Cardiopulmonary Bypass Change Olfaction?","official_title":"Does Cardiopulmonary Bypass Change Olfaction?","primary_completion_date":"2015-10-31","study_type":"Observational","rec_status":"Withdrawn","completion_date":"2015-12-31","last_update":"2020-03-17","description":"The loss of the sense of smell, anosmia, can have profound effects on the lives of those who suffer from it. In our clinical practice, we have encountered several patients complaining of anosmia after recently undergoing surgery requiring cardiopulmonary bypass. We want to investigate this peculiar observation and determine if such a link exists. Thus far, there have been no similar studies published, and as such, no previous evidence on this matter. This study will help formalise and clarify these observations, empowering clinicians to better inform patients in the future; if cardiopulmonary bypass procedures do carry a risk of anosmia. This study may also give rise to further research into the matter.","other_id":"R03463","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"50 patients undergoing elective surgery requiring cardiopulmonary bypass (study group)","criteria":"\n        Inclusion Criteria:\r\n\r\n        - English speaking volunteers above 18 years of age.\r\n\r\n        Exclusion Criteria:\r\n\r\n        - Pre-existing olfaction disorder, nasal polyps.\r\n      ","sponsor":"Manchester University NHS Foundation Trust","sponsor_type":"Other","conditions":"Anosmia","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"1) Sniffin sticks score out of 16","time_frame":"1 day","description":"1) Objective scoring based smell test kit"},{"outcome_type":"secondary","measure":"2) Dresden questionnaire of olfactory disorder score","time_frame":"1 day","description":"2) Scoring based on validated questionnaire"}]}
{"nct_id":"NCT02230046","start_date":"2014-10-31","phase":"Phase 1","enrollment":102,"brief_title":"Bioequivalence Study of Abiraterone Acetate Coated and Uncoated Tablet Formulations in Healthy Male Participants","official_title":"A Single-Dose, Open-Label, Randomized, 3-Way Crossover Pivotal Study to Assess the Bioequivalence of 2 Abiraterone Acetate Coated Tablet Formulations With Respect to the Current Commercial Abiraterone Acetate Uncoated Tablet Formulation Under Fasted Conditions in Healthy Male Subjects","primary_completion_date":"2014-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-11-30","last_update":"2016-01-20","description":"The purpose of this study is to determine the bioequivalence (equivalence of pharmacokinetic parameters) of 2 abiraterone acetate coated tablet formulations with respect to the current commercial abiraterone acetate uncoated tablet formulation under fasted (without eating or drinking) conditions in healthy male participants.","other_id":"CR105286","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  If sexually active, participants must always use a condom during the study and for 1\r\n             week after last intake of study drug. If sexually active with a pregnant woman or\r\n             woman of child-bearing potential, participants must agree to abstain from intercourse\r\n             during the study and for 1 week after last intake of study drug. Participants should\r\n             not donate sperm during the study and for 1 week after receiving the last dose of\r\n             study drug\r\n\r\n          -  Body mass index (BMI; weight [kilogram(kg)]/height^2 [meter square (m^2)]) between\r\n             18.5 and 30.0 kg/m^2, (inclusive), and body weight not less than 50 kg\r\n\r\n          -  Blood pressure (after the participants is supine for 5 minutes) between 90 and 140\r\n             millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic\r\n             at Screening\r\n\r\n          -  A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and\r\n             function at Screening as specified in the protocol\r\n\r\n          -  Non-smoker, no history of smoking or use of nicotine-containing substances within the\r\n             previous 2 months, as determined by medical history or participant's verbal report\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of or current clinically significant medical illness including (but not\r\n             limited to) cardiac arrhythmias or other cardiac disease, hematologic disease,\r\n             coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid\r\n             abnormalities, significant pulmonary disease, including bronchospastic respiratory\r\n             disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease,\r\n             neurologic or psychiatric disease, infection, or any other illness that the\r\n             investigator considers should exclude the participants or that could interfere with\r\n             the interpretation of the study results\r\n\r\n          -  Clinically significant abnormal values for hematology or clinical chemistry at\r\n             Screening\r\n\r\n          -  Presence of sexual dysfunction (abnormal libido, erectile dysfunction, etc.) or any\r\n             medical condition that would affect sexual function\r\n\r\n          -  Use of any prescription or nonprescription medication (including vitamins and herbal\r\n             supplements), except for acetaminophen, within 14 days before the first dose of the\r\n             study drug is scheduled through study completion\r\n\r\n          -  History of, or a reason to believe a participants has a history of drug or alcohol\r\n             abuse within the past 5 years\r\n      ","sponsor":"Janssen Research & Development, LLC","sponsor_type":"Industry","conditions":"Healthy","interventions":[{"intervention_type":"Drug","name":"Drug: Abiraterone acetate (Treatment A)","description":"Participants will receive a single oral 1000 mg dose of abiraterone acetate as Treatment A (current commercial formulation, 4*250 mg uncoated tablets) under fasted conditions on Day 1 of period as specified in the protocol."},{"intervention_type":"Drug","name":"Drug: Abiraterone acetate (Treatment B)","description":"Participants will receive a single oral 1000 mg dose of abiraterone acetate as Treatment B (current commercial formulation, 4*250 mg coated tablets) under fasted conditions on Day 1 of period as specified in the protocol."},{"intervention_type":"Drug","name":"Drug: Abiraterone acetate (Treatment B)","description":"Participants will receive a single oral 1000 mg dose of abiraterone acetate as Treatment C (new composition, 2*500 mg coated tablets) under fasted conditions on Day 1 of period as specified in the protocol."}],"outcomes":[{"outcome_type":"primary","measure":"Maximum Plasma Concentration (Cmax) of abiraterone acetate","time_frame":"Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period","description":"The Cmax is the maximum observed plasma concentration of abiraterone acetate."},{"outcome_type":"primary","measure":"Area Under the Plasma Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC [0-last]) of abiraterone acetate","time_frame":"Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period","description":"The AUC (0-last) is the area under the plasma abiraterone acetate concentration-time curve from time zero to time of the last quantifiable concentration."},{"outcome_type":"primary","measure":"Area Under the Plasma Concentration-Time Curve From Time 0 to Infinite Time (AUC [0-infinity]) of abiraterone acetate","time_frame":"Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period","description":"The AUC (0-infinity) is the area under the plasma abiraterone acetate concentration-time curve from time 0 to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z), in which AUC(0-last) is area under the plasma abiraterone acetate concentration-time curve from time zero to time of the last quantifiable concentration, C(last) is the last observed quantifiable concentration and lambda(z) is elimination rate constant."},{"outcome_type":"secondary","measure":"Time to Reach the Maximum Plasma Concentration (Tmax) of abiraterone acetate","time_frame":"Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period","description":"The Tmax is the time to reach the maximum observed plasma concentration of abiraterone acetate."},{"outcome_type":"secondary","measure":"Percentage of Area Under the Plasma Concentration-Time Curve Extrapolated From Last Measurable Concentration to Infinite Time (%AUC, ext) of abiraterone acetate","time_frame":"Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period","description":"Percentage of area under the plasma abiraterone acetate concentration-time curve extrapolated from last measurable concentration to infinite time (%AUC, ext) is calculated using formula: ((AUC [0-infinity] minus- AUC [0-last)]/AUC [0-infinity])*100."},{"outcome_type":"secondary","measure":"Elimination Half-Life (t 1/2, Lambda) of abiraterone acetate","time_frame":"Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period","description":"Elimination half-life (t 1/2, Lambda) is associated with the terminal slope (lambda [z]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda(z)."},{"outcome_type":"secondary","measure":"Rate Constant (Lambda [z]) of abiraterone acetate","time_frame":"Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period","description":"Lambda (z) is the first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve."},{"outcome_type":"secondary","measure":"Time to Last Quantifiable Plasma Concentration (T [last]) of abiraterone acetate","time_frame":"Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose on Day 1 of each period","description":"Time to last quantifiable plasma concentration of abiraterone acetate will be observed."},{"outcome_type":"secondary","measure":"Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)","time_frame":"Screening up to follow-up (5 to 7 days after last dose administration)","description":"An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly."}]}
{"nct_id":"NCT02245594","start_date":"2014-10-31","enrollment":20,"brief_title":"GI Symptoms and Sleep Disturbances in Patients With Quiescent Crohns Disease","official_title":"Gastrointestinal Motility and Sleep Disturbances in Patients With Quiescent Crohn's Disease","primary_completion_date":"2015-05-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2015-10-31","last_update":"2014-09-19","description":"In this study we would like to clarify the effect of long lasting Crohn's Disease on motility of the gastrointestinal system in patient and the effect regarding sleep disturbances. This will be done with a newly developed 3D-Motility-and-Transit-detector (Motilis Medica, Schweiz) and the well known polysomnographic equipment. Our hypothesises are: Patients with ileocoecal and/or colonic CD in remission and gastrointestinal symptoms have abnormal colonic transit (primary endpoint). 1. Patients with ileocoecal and/or colonic CD in remission and gastrointestinal symptoms have abnormal gastric emptying and small intestinal transit (secondary endpoints). 2. Total and segmental transit times found in patients with CD will be compared with corresponding transit times in healthy volunteers found in a previous study. 3. Patients with ileocoecal and/or colonic CD in remission have abnormal sleep patterns. 4. Nocturnal basic colonic activity, have changed in patients with ileocoecal and/or colonic CD in remission and sleep disturbances.","other_id":"MbCrohnRemission+Symp","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":85,"population":"Patients with quiescent Crohn's disease who still have gastrointestinal complaints.Found in\r\n        the out-patient clinic at Department V (Gastroenterology and Hepatology).","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with CD based on accepted endoscopic and histological criteria (according to\r\n             ECCO guidelines (17) )\r\n\r\n          -  Age 18 years\r\n\r\n          -  A minimum disease duration of five years\r\n\r\n          -  Remission defined by Faecal calprotectin < 100 and CRP level within normal values for\r\n             a minimum of 1 month\r\n\r\n          -  Baseline values:\r\n\r\n               -  CRP normal\r\n\r\n               -  Faecal calprotectin < 100\r\n\r\n          -  Ileocoecal and/or colic localization of disease (Montreal phenotype classification)\r\n\r\n          -  One or more IBS-like-symptoms (abdominal pain and discomfort, diarrhea, constipation)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Stricturizing CD\r\n\r\n          -  Obvious stenotic symptoms\r\n\r\n          -  Previous major gastrointestinal surgery\r\n\r\n          -  Diagnosis of other gastrointestinal diseases affecting motility (ex. Coeliac disease)\r\n\r\n          -  Medication altering gastrointestinal motility\r\n\r\n          -  Hepatobiliary disease (PSC)\r\n\r\n          -  Diabetes Mellitus\r\n\r\n          -  Metabolic disorder\r\n\r\n          -  Bacterial overgrowth (hydrogen breath test)\r\n\r\n          -  Planned MR scan in the four weeks following capsule intake (safety precaution)\r\n\r\n          -  Abdominal diameter > 140 cm\r\n\r\n          -  Implanted electronic devices (pacemaker, ICD, etc.)\r\n\r\n          -  Diagnosed sleep disorder\r\n\r\n          -  Pregnancy and breast feeding\r\n      ","sponsor":"University of Aarhus","sponsor_type":"Other","conditions":"Crohn's Disease|Inflammatory Bowel Disease|Sleep Disturbances","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Total and segmental gastrointestinal transit time in patients suffering from CD","time_frame":"Expected average total transit time less than two days, analyzed after 2-3 days"},{"outcome_type":"primary","measure":"Abnormal sleep pattern in patients with ileocoecal and/or colonic CD in remission","time_frame":"Recorded during a single night, analyzed one of the two following days."},{"outcome_type":"secondary","measure":"Gastric emptying in CD patients","time_frame":"Less than 1 day, analyzed after 1-3 days"},{"outcome_type":"secondary","measure":"Small intestinal transit time in CD patients","time_frame":"Less than 2 days, analyzed after 2-3 days"},{"outcome_type":"secondary","measure":"Segmental colonic transit time in CD patients","time_frame":"Average less than 2 day, analyzed after 2-3 days"},{"outcome_type":"secondary","measure":"Nocturnal basic colonic activity in patients with ileocoecal and/or colonic CD in remission and sleep disturbances","time_frame":"Recorded during one night, analyzed one of the two following days"}]}
{"nct_id":"NCT02269891","start_date":"2014-10-31","phase":"Phase 2","enrollment":119,"brief_title":"A Clinical Trial on the Efficacy of a Combination Herbal Product, Biotropics' Nu Femme, on Menopausal Symptoms and Quality of Life in Women","official_title":"A Randomized Double-Blind, Placebo-Controlled, Parallel Clinical Trial on the Efficacy of a Combination Herbal Product, Biotropics' Nu Femme, on Menopausal Symptoms and Quality of Life in Women","primary_completion_date":"2018-09-27","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-09-27","last_update":"2018-11-13","description":"The purpose of this study is to assess the effectiveness of an herbal combination product called Nu Femme, on menopausal symptoms in peri-menopausal women.","other_id":"14NMHB","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"Triple","sampling_method":"","gender":"Female","minimum_age":40,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Female of any race between the ages of 40 and 55 years (inclusive)\r\n\r\n          -  Experiencing perimenopause (irregular menstrual cycles (>3 months) or cessation of\r\n             menstrual period for at least 3 months within the last 12 months) OR women in\r\n             menopause (cessation of menstrual period for at least 12 months).\r\n\r\n          -  Peri-menopausal women must have an endometrial stripe < 8 mm by ultrasound at\r\n             screening and menopausal women must have an endometrial stripe < 5 mm. Not required\r\n             for subjects without an intact uterus.\r\n\r\n          -  Women with an intact cervix must have a pap smear that is normal within 12 months of\r\n             screening.\r\n\r\n          -  Experiences menopausal transition symptoms such as hot flushes, sweating, sleep\r\n             disturbance, migraine, anxiety, vaginal dryness and sexual problems.\r\n\r\n          -  Minimum of 4 hot flashes per day or 28 per week\r\n\r\n          -  Total scores of Menopause Rating Scale 17 indicating the menopausal symptoms are\r\n             moderate or severe\r\n\r\n          -  TSH screening to exclude undiagnosed hyperthyroidism\r\n\r\n          -  Willingness and ability to give written informed consent and willingness and ability\r\n             to understand, to participate and to comply with the study requirements.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Women with a positive mammogram\r\n\r\n          -  Significant cardiac history including uncontrolled hypertension (defined as untreated\r\n             systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg) or\r\n             current diagnosis of any major diseases of the cardiovascular, hepatic, renal,\r\n             gastrointestinal, pulmonary or endocrine systems\r\n\r\n          -  Uncontrolled hyperlipidemia\r\n\r\n          -  History or current diagnosis of breast cancer or breast cancer in an identical twin,\r\n             or any cancer (except non-melanomatous skin cancer) diagnosed less than 5 years prior\r\n             to randomization. Subjects with other cancers in full remission more than 5 years\r\n             after diagnosis are acceptable with the exceptions of breast cancer or genital organ\r\n             cancer (e.g., cervical cancer, uterine cancer, endometrial cancer, or ovarian cancer)\r\n\r\n          -  Uncontrolled diabetes (Type I or Type II)\r\n\r\n          -  Uncontrolled and/or untreated thyroid disorder\r\n\r\n          -  History or current diagnosis of any major diseases of the cardiovascular, hepatic,\r\n             renal, gastrointestinal, pulmonary or endocrine systems\r\n\r\n          -  History or current diagnosis of autoimmune conditions, immunodeficiency or\r\n             gynaecological disease\r\n\r\n          -  Clinically significant mental depression that is not well-controlled in the opinion of\r\n             the investigator\r\n\r\n          -  Subject has undergone major surgery within the past one year prior to the\r\n             randomization visit, except cholecystectomy, and appendectomy\r\n\r\n          -  Subject smokes more than 15 cigarettes a day\r\n\r\n          -  History of alcohol or drug abuse within the past year\r\n\r\n          -  Subject has demonstrated non-compliance with treatment while enrolled in other\r\n             experimental protocols to which the Investigator has knowledge\r\n\r\n          -  Subject has a mental disability or significant mental illness, legal incapacity or\r\n             limited legal capacity or any other lack of fitness, in the Investigator's opinion, to\r\n             preclude subject's participation in or to complete the study\r\n\r\n          -  History or findings of undiagnosed abnormal vaginal bleeding within the previous two\r\n             years prior to the randomization visit, including conditions that, in the\r\n             Investigator's opinion are likely to be the source of unpredictable vaginal bleeding\r\n             (i.e. leiomyoma or endometrial polyps)\r\n\r\n          -  Subject has uterine fibroids (> 2cm) or endometriosis. This assessment will be based\r\n             on the size of the uterus of each participant and will be assessed by the Qualified\r\n             Investigator\r\n\r\n          -  Pregnant, breastfeeding, or planning to become pregnant during the course of the trial\r\n\r\n          -  Positive urine pregnancy test result\r\n\r\n          -  Polycystic ovary syndrome (PCOS)\r\n\r\n          -  History of abnormal Pap smear\r\n\r\n          -  Significant abnormal liver function as defined as AST and/or ALT > 2 x the upper limit\r\n             of normal (ULN), and/or bilirubin > 2 x the ULN\r\n\r\n          -  eGFR <60\r\n\r\n          -  Bleeding disorders or anaemia of any etiology defined as haemoglobin  110 g/L\r\n\r\n          -  Subject has taken any of the following medications in the time periods specified prior\r\n             to the screening visit and during the study\r\n\r\n        Sex hormones:\r\n\r\n        Vaginal rings and vaginal creams, ointments or gels 1 week Transdermal or topical 4 weeks\r\n        DHEA within 24 weeks Natural supplements advertised to have hormonal effects within 4 weeks\r\n        Oral within 4 weeks Intrauterine progestin implants within 8 weeks Progestin implants and\r\n        estrogen alone injections within 12 weeks Injected progestin and estrogen or androgen\r\n        implants or pellets within 24 weeks\r\n\r\n        Gonadotropin-releasing hormone (GnRH) agonists within 24 weeks\r\n\r\n        Selective Estrogen Receptor Modulators (SERMs) within 4 weeks\r\n\r\n        Glucocorticoids - Chronic high dose ( 7.5 mg prednisone per day or equivalent) for the\r\n        past 12 weeks. Exceptions: Chronic low dose corticosteroid use (< 7.5 mg prednisone per\r\n        day, or equivalent) is permitted provided the subject has been stabilized on a dose for at\r\n        least 12 weeks prior to randomization and maintains the current dose and dosing regimen\r\n        during the study. Acute topical, inhaled, or oral (e.g. dose packs) use is not exclusionary\r\n        and will be permitted during the course of the study.\r\n\r\n        Antidepressant and/or antianxiety medications within 4 weeks unless a chronic stable dose\r\n        has been maintained for greater than 12 weeks. Subject must maintain current dose and\r\n        dosing regimen during the study. Use of Effexor (Venlafaxine HCl) within 4 weeks is\r\n        exclusionary. Use of Dixarit (Clonidine HCl) within 2 weeks is exclusionary.\r\n\r\n        Thyroid or anti-epileptic medications within 12 weeks unless a chronic stable dose has been\r\n        maintained for greater than 12 weeks prior to randomization. Subjects must maintain current\r\n        dose and dosing regimen during the study\r\n\r\n        Use of Prostaglandins within 4 weeks\r\n\r\n        Other investigational study medications within 4 weeks\r\n\r\n        Current use of propranolol\r\n\r\n        Current use of an intrauterine device (IUD)\r\n\r\n        Use of natural health products, such as primrose oil, black cohosh, soy products, other\r\n        than vitamin and/or mineral supplements within 4 weeks\r\n\r\n          -  Known allergy or hypersensitivity to study product ingredients\r\n\r\n          -  Subjects on a weight reduction program or a medically supervised diet.\r\n\r\n          -  Unexplained weight loss or weight gain of more than 5 kg in the month prior to\r\n             randomization\r\n\r\n          -  Any other condition which in the Investigator's opinion may adversely affect the\r\n             subject's ability to complete the study or its measures or which may pose significant\r\n             risk to the subject\r\n      ","sponsor":"KGK Science Inc.","sponsor_type":"Industry","conditions":"Menopausal Symptoms","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Nu Femme","description":"Combination product of Labisia pumila and Eurycoma longifolia extracts"},{"intervention_type":"Other","name":"Other: Placebo"}],"outcomes":[{"outcome_type":"other","measure":"Bone markers","time_frame":"Baseline to week 12","description":"NTX and BSALP"},{"outcome_type":"other","measure":"Blood safety parameters","time_frame":"Baseline to week 12","description":"CBC, electrolytes (Na K CL), glucose, creatinine, BUN, AST, ALT, GGT, bilirubin, Ca, albumin"},{"outcome_type":"other","measure":"Pap smear","time_frame":"Baseline to week 12","description":"Histological analysis for abnormal cells"},{"outcome_type":"other","measure":"Pelvic ultrasound","time_frame":"Baseline to week 12","description":"To determine changes in endometrial thickness"},{"outcome_type":"other","measure":"Incidence of adverse events","time_frame":"Baseline to week 12"},{"outcome_type":"primary","measure":"Frequency and severity of hot flashes","time_frame":"Baseline to week 12","description":"Assessed based on hot flash symptoms score"},{"outcome_type":"secondary","measure":"Frequency and severity of joint pain","time_frame":"Baseline to week 12","description":"Assessed based on joint pain symptoms score"},{"outcome_type":"secondary","measure":"Frequency and severity of hot flashes","time_frame":"Baseline to week 24","description":"Assessed based on hot flash symptoms score"},{"outcome_type":"secondary","measure":"Frequency and severity of hot flashes","time_frame":"Week 12 to week 24","description":"Assessed based on hot flash symptoms score"},{"outcome_type":"secondary","measure":"Frequency and severity of joint pain","time_frame":"Baseline to week 24","description":"Assessed based on joint pain symptoms score"},{"outcome_type":"secondary","measure":"Frequency and severity of joint pain","time_frame":"Week 12 to week 24","description":"Assessed based on joint pain symptoms score"},{"outcome_type":"secondary","measure":"Health related quality of life","time_frame":"Baseline to weeks 3, 6, 12 and 24","description":"Assessed using the Menopause Rating Scale (MRS)"},{"outcome_type":"secondary","measure":"Menopause specific quality of life","time_frame":"Baseline to weeks 3, 6, 12 and 24","description":"Assessed using the Menopause Specific Quality of Life questionnaire (MENQOL)"},{"outcome_type":"secondary","measure":"Serum hormone concentrations","time_frame":"Baseline to week 12","description":"Estradiol-17b, FSH, LH, total testosterone and free testosterone"},{"outcome_type":"secondary","measure":"Serum Lipid Profile","time_frame":"Baseline to week 12","description":"Total cholesterol, HDL-C, LDL-C and triglycerides"}]}
{"nct_id":"NCT02789202","start_date":"2014-10-31","phase":"N/A","enrollment":100,"brief_title":"Diammine Silver Fluoride in Arresting Enamel Caries Lesions on Babies' Occlusal Surfaces","official_title":"Efficacy, Cost-efficacy and Parental Acceptability of Using Diammine Silver Fluoride in Arresting Enamel Caries Lesions on Babies' Occlusal Surfaces","primary_completion_date":"2018-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2020-08-31","last_update":"2018-03-21","description":"This study aims to verify the actual possibility of using silver diammine fluoride (SDF) in arresting enamel caries lesions on occlusal surfaces of primary molars in babies. Besides, the cost-efficacy and also parental acceptability of using SDF will be evaluated. For this, 100 babies 1-3 years will be examined and treated in a mobile dental unit, which will temporarily be parked in public schools of Barueri, Sao Paulo, Brazil. The caries diagnosis will be conducted using the International Caries Detection and Assessment System (ICDAS). Babies with initial lesions will be randomized concerning the treatment in Group A (SDF) and Group B (fluoride varnish). Participants will be examined in the baseline and followed by 6, 12, 18 and 24 months. As primary outcome, caries progression into dentine will be considered. Acceptability reported by parents after treatments, the time and estimated money spent for treating will also be collected. Social and biological data that could be related to efficacy of techniques will be also collected. Multilevel analyses will be performed to check which technique will be most effective and possible factors associated to its efficacy. Discomfort, acceptability and costs will be compared between/among the approaches used to arrest enamel caries lesions.","other_id":"SDFtrials-03","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":1,"maximum_age":3,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Babies 1 to 3 years;\r\n\r\n          -  Babies with initial dental caries lesion.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Parents who do not consent.\r\n      ","sponsor":"University of Sao Paulo","sponsor_type":"Other","conditions":"Dental Caries","interventions":[{"intervention_type":"Other","name":"Other: Silver diamine fluoride","description":"Treatment of initial dental caries lesion in occlusal surface using the silver diamine fluoride."},{"intervention_type":"Other","name":"Other: Fluoride Varnish","description":"Treatment of initial dental caries lesion in occlusal surface using the fluoride varnish"}],"outcomes":[{"outcome_type":"primary","measure":"Number of caries lesions which progressed to dentine","time_frame":"24 months","description":"Assessment of caries lesions severity in order to identify those which progressed to dentine (ICDAS scores 4 to 6)"},{"outcome_type":"secondary","measure":"Parental acceptability to the treatment using a VAS scale","time_frame":"12 months","description":"Parents will be asked to report their satisfaction with the treatment using a VAS scale"},{"outcome_type":"other","measure":"Direct and Indirect Costs of initial procedures and consequent interventions during 24 months","time_frame":"24 months"}]}
{"nct_id":"NCT02234908","start_date":"2014-10-31","phase":"N/A","enrollment":301,"brief_title":"Rewards for Tuberculosis Contact Screening","official_title":"Rewards for Tuberculosis Contact Screening","primary_completion_date":"2016-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-12-31","last_update":"2021-01-08","description":"This pilot project is an evaluation of the feasibility, acceptability, and cost of offering an economic reward, in the form of a shopping voucher, to the household contacts of index patients (outpatient drug-susceptible and drug-resistant TB patients) who present at the study clinic for TB screening and optional HIV testing, providing a reward to the index patients for participating, and entering index patients whose contacts do present into a lottery to win a prize.The effectiveness of the intervention in screening a high proportion of contacts will be compared to existing published data from studies of active case-finding through home visits and of the status quo passive case finding. If successful, this pilot project will create a demand for screening among high risk patients, who will be rewarded for identifying themselves to the healthcare system, and could prove to be an affordable alternative to resource-intensive home visits. It will also shift responsibility for contact tracing from overburdened clinic staff to those who have the most to gain from early case detection-the patients and their families.","other_id":"H-33047","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion criteria for index cases:\r\n\r\n          -  Adult patients (>18 years)\r\n\r\n          -  Newly diagnosed with pulmonary TB (drug-susceptible or drug-resistant) or initiating\r\n             treatment for TB at one of the study sites\r\n\r\n        Exclusion criteria for index cases:\r\n\r\n          -  Resident outside the site's permissible catchment area for service delivery\r\n\r\n          -  No household contacts (live alone)\r\n\r\n          -  Admitted for inpatient care immediately following their TB diagnosis, and thus not\r\n             readily able to distribute the referral cards\r\n\r\n          -  Not physically, mentally, or emotionally able to participate in the study, in the view\r\n             of study staff\r\n\r\n          -  Previously enrolled in the same study\r\n\r\n          -  Declines to provide written informed consent to participate\r\n\r\n          -  Unable to speak any of the languages for which consent documents are available and not\r\n             accompanied by person who can\r\n\r\n        Inclusion criteria for contacts:\r\n\r\n          -  Usually spend at least 4 nights per week in the same household as an index case\r\n\r\n          -  Can provide referral card given to contact by index patient\r\n\r\n        Exclusion criteria for contacts:\r\n\r\n          -  Currently on any type of TB treatment\r\n\r\n          -  Not able to present any form of identification that matches the information on the\r\n             referral card\r\n\r\n          -  Previously enrolled in the same study\r\n\r\n          -  Declines to provide written informed consent to participate\r\n\r\n          -  Unable to speak any of the languages for which consent documents are available and not\r\n             accompanied by person who can\r\n\r\n        Inclusion criteria for interview respondents:\r\n\r\n          -  Experience with the intervention as provider or patient\r\n\r\n          -  Written informed consent to be interviewed\r\n\r\n        Exclusion criteria for contacts:\r\n\r\n         None\r\n      ","sponsor":"Boston University","sponsor_type":"Other","conditions":"Tuberculosis|Drug-resistant Tuberculosis","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Contacts","description":"Household contacts who come to the study clinic, present a referral card, and complete TB symptom screening will receive a shopping voucher of $5-10 value."},{"intervention_type":"Behavioral","name":"Behavioral: Index","description":"Index subjects will be entered in a prize lottery if any of their contacts complete TB symptom screening at the study clinic."}],"outcomes":[{"outcome_type":"primary","measure":"Proportion of household contacts volunteering for TB symptom screening","time_frame":"30 days","description":"The primary quantitative outcome is uptake of TB symptom screening, defined as the proportion of reported household contacts who complete TB symptom screening within 1 month of index subject enrollment."}]}
{"nct_id":"NCT01910376","start_date":"2014-10-31","enrollment":125,"brief_title":"Cancer in Nursing Home Residents","official_title":"Cancer in Elderly Nursing Home Residents in Belgium: Prospective Cohort Study Including Translational Research to Develop Better Prognostic Tools to Help With Treatment Decisions in the Elderly","primary_completion_date":"2017-12-31","study_type":"Observational [Patient Registry]","rec_status":"Completed","completion_date":"2017-12-31","last_update":"2019-03-13","description":"Cancer is a disease of the elderly. Cancer incidence is 11-fold higher in persons over the age of 65, than in younger ones. Approximately 60% of all cancers and 70% of cancer mortality occurs in people older than 65 years. Moreover, due to the aging of the population in the Western world the number of elderly people is expected to increase and therefore the number of older cancer patients is expected to rise. Despite this rapid increase in cancer incidence and cancer-related mortality with age, our knowledge about ageing and cancer and about optimal treatment for older cancer patients is still far from adequate. Therefore, it is clear that cancer in the elderly is a major and increasing health problem. A key problem in geriatric oncology research is the important selection bias because very old/frail patients, are very rarely included in clinical trials. Changes in the patterns of health care delivery have shifted the care of the elderly from acute care settings to the community and long-term care facilities. As the European population ages, more and more people will become nursing home residents, many of whom will have a suspicion of, or be diagnosed with, and eventually die from, cancer. Although cancer is very common in elderly nursing home residents, it is poorly studied. This lack of information may impact on clinical decision making and the appropriateness of treatments offered and therefore collection of this information is needed. This project has two main objectives. The first objective is to report on demographics, referral patterns and motives for non-referral, anti-cancer treatments and outcome of patients in nursing homes with suspected or diagnosed active invasive cancer where a diagnostic or treatment decision has to be taken. The second objective is to develop better prognostic tools (for survival) including biological markers of ageing to help treatment decisions in the elderly.","other_id":"EORTC-1221","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":65,"population":"Residents ( 65 years) in a nursing home in the Armonea network in Belgium.","criteria":"\n        Inclusion Criteria:\r\n\r\n        All individuals:\r\n\r\n          -  Age  65 years\r\n\r\n          -  Residents in a nursing home in the Armonea network in Belgium.\r\n\r\n          -  Absence of any psychological, familial, or sociological condition potentially\r\n             hampering compliance with the study protocol; those conditions should be discussed\r\n             with the patient/proxy before registration in the study.\r\n\r\n          -  Written informed consent must be given according to ICH/GCP, and national/local\r\n             regulations.\r\n\r\n          -  The treating general practitioner (GP) is willing to provide medical information\r\n             required by the study.\r\n\r\n        Cancer patient cohort:\r\n\r\n        Patients must have a new cancer event defined as one of:\r\n\r\n          -  A strong clinical suspicion (based on physician's judgement) of a new cancer where a\r\n             diagnostic or therapeutic decision needs to be taken.\r\n\r\n          -  A strong clinical suspicion (based on physician's judgement) of progression of a\r\n             previously known cancer where a diagnostic or therapeutic decision needs to be taken.\r\n\r\n          -  Diagnosis of a new cancer where a diagnostic or therapeutic decision needs to be\r\n             taken.\r\n\r\n          -  Diagnosis of progression of a previously known cancer where a diagnostic or\r\n             therapeutic decision needs to be taken.\r\n\r\n        All invasive cancer types and all histologies are eligible. All lines of treatment are\r\n        eligible. Patients who are diagnosed with cancer during routine medical examinations for\r\n        some other medical condition\r\n\r\n        Control cohort:\r\n\r\n         Absence of known active invasive cancer, or strong clinical suspicion of cancer (based on\r\n        physician's judgement) at baseline.\r\n\r\n        Exclusion criteria:\r\n\r\n        Patients who were not suspected to have cancer (progression) in the nursing home, but are\r\n        hospitalized for other (medical) reasons, are then diagnosed with cancer during\r\n        hospitalization.\r\n      ","sponsor":"European Organisation for Research and Treatment of Cancer - EORTC","sponsor_type":"Other","conditions":"Armonea Nursing Homes Residents","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Prognostic capacity of p16INK4a expression in T lymphocytes on Overall Survival","time_frame":"The analyses will be performed when 90 deaths will have been observed"},{"outcome_type":"primary","measure":"Demographics, referral patterns and motives for non-referral, anti-cancer treatments and outcome in nursing home patients with cancer or with strong clinical suspicion of cancer.","time_frame":"Baseline, every 3 months and for max. 2 years"},{"outcome_type":"secondary","measure":"Comparison of baseline parameters and outcome between nursing home cancer patients (cancer patient cohort) and nursing home non-cancer patients (control cohort)","time_frame":"Baseline, every 3 months and for max. 2 years"},{"outcome_type":"secondary","measure":"Prognostic capacity of baseline clinical markers and Porock scale on OS, functional decline, cognitive decline and Quality of Life separately in nursing home cancer group (cancer patient cohort) and non-cancer group (control cohort).","time_frame":"Baseline, every 3 months and for max. 2 years"},{"outcome_type":"secondary","measure":"Prognostic capacity of other biomarkers of ageing on OS in the control group of nursing home patients without cancer.","time_frame":"2 years"}]}
{"nct_id":"NCT02270398","start_date":"2014-10-31","phase":"N/A","enrollment":84,"brief_title":"Dual-task Training in Chronic Stroke","official_title":"Training Dual-task Balance and Walking in Community-dwelling Older Adults With Chronic Stroke: a Randomized Controlled Trial","primary_completion_date":"2016-06-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2016-12-31","last_update":"2014-11-11","description":"Background Functional community ambulation not only requires a critical level of postural control and walking skills, but also the ability to engage in cognitive tasks while walking (i.e., dual-task walking) and adapt to the constantly-changing environmental contexts. There is evidence showed that dual-task balance and gait performance is significantly impaired after stroke. Increasing evidence also suggests that dual-task balance and gait performance is useful for predicting falls among individuals with stroke. Considering the high clinical relevance of dual-task balance and gait performance, it is essential that stroke rehabilitation adequately addresses dual-task deficits. Developing specific dual-task balance and gait training to enhance dual-task performance is thus necessary to promote community ambulation and reintegration. Study Aim The aim of this Introduction Many individuals after stroke continue to cope with residual physical impairments after discharge from hospital. One of the major problems encountered by people after stroke is community reintegration. Functional community ambulation not only requires a critical level of postural control and walking skills, but also the ability to engage in cognitive tasks while walking (i.e., dual-task walking) and adapt to the constantly-changing environmental contexts. There has been an increasing awareness of the importance of dual-task gait performance in community-dwelling individuals with stroke in the past few years. There is evidence showed that dual-task balance and gait performance is significantly impaired after stroke. Increasing evidence also suggests that dual-task balance and gait performance is useful for predicting falls among individuals with stroke. Considering the high clinical relevance of dual-task balance and gait performance, it is essential that stroke rehabilitation adequately addresses dual-task deficits. Developing specific dual-task balance and gait training to enhance dual-task performance is thus necessary to promote community ambulation and reintegration. Study Aim This will be a single-blinded randomized controlled trial (RCT).The aim of this study is to examine the efficacy of a dual-task exercise program on cognitive-motor interference in balance and walking tasks, balance self-efficacy, participation in everyday activities, community reintegration and incidence of falls among individuals with chronic stroke.","other_id":"HSEARS20140714003-01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  diagnosis of a stroke\r\n\r\n          -  more than 6 months of stroke onset\r\n\r\n          -  aged 50 years or above\r\n\r\n          -  community-dwelling\r\n\r\n          -  medically stable\r\n\r\n          -  score 21 on the Montreal Cognitive Assessment (MoCA)\r\n\r\n          -  score  25 on the Mini Balance Evaluation Systems Test (Mini-BESTest)\r\n\r\n          -  able to ambulate without physical assistance of another person as determined during\r\n             the 10-meter walk test\r\n\r\n          -  ability to follow 3-step commands\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  having neurological conditions other than stroke\r\n\r\n          -  not community-dwelling prior to the stroke event\r\n\r\n          -  significant receptive and expressive aphasia\r\n\r\n          -  severe and uncorrected hearing or visual deficits\r\n\r\n          -  serious musculoskeletal disorders (e.g. amputation)\r\n\r\n          -  serious cardiovascular conditions affecting the ability to participate in exercise\r\n             training\r\n\r\n          -  pain experienced at rest or movement\r\n\r\n          -  other serious illnesses that preclude participation\r\n      ","sponsor":"The Hong Kong Polytechnic University","sponsor_type":"Other","conditions":"Stroke","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Dual-task training group","description":"Balance and gait exercises while simultaneously engaging in a secondary cognitive task."},{"intervention_type":"Behavioral","name":"Behavioral: Single-task training group","description":"Balance/gait exercises and cognitive exercises done separately."},{"intervention_type":"Behavioral","name":"Behavioral: Flexibility and strength training group","description":"Whole-body flexibility exercises, upper limb strengthening exercises."}],"outcomes":[{"outcome_type":"secondary","measure":"Motricity Index","time_frame":"week 16","description":"A muscle strength test"},{"outcome_type":"secondary","measure":"Chedoke Arm and Hand Activity Inventory","time_frame":"week 0","description":"An arm function test"},{"outcome_type":"secondary","measure":"Motricity Index","time_frame":"week 0","description":"A muscle strength test"},{"outcome_type":"secondary","measure":"Motricity Index","time_frame":"week 8","description":"A muscle strength test"},{"outcome_type":"primary","measure":"Timed-up-and-go test with and without dual-task","time_frame":"week 0","description":"A walking test"},{"outcome_type":"primary","measure":"Timed-up-and-go test with and without dual-task","time_frame":"week 8","description":"A walking test"},{"outcome_type":"primary","measure":"Timed-up-and-go test with and without dual-task","time_frame":"week 16","description":"A walking test"},{"outcome_type":"secondary","measure":"10-meter walk test with and without dual-task","time_frame":"week 0","description":"A walking test"},{"outcome_type":"secondary","measure":"10-meter walk test with and without dual-task","time_frame":"week 8","description":"A walking test"},{"outcome_type":"secondary","measure":"10-meter walk test with and without dual-task","time_frame":"week 16","description":"A walking test"},{"outcome_type":"secondary","measure":"Sensory organization test with and without dual-task","time_frame":"week 0","description":"A standing balance test"},{"outcome_type":"secondary","measure":"Sensory organization test with and without dual-task","time_frame":"week 8","description":"A standing balance test"},{"outcome_type":"secondary","measure":"Sensory organization test with and without dual-task","time_frame":"week 16","description":"A standing balance test"},{"outcome_type":"secondary","measure":"Obstacle crossing with and without dual-task","time_frame":"week 0","description":"A walking test"},{"outcome_type":"secondary","measure":"Obstacle crossing with and without dual-task","time_frame":"week 8","description":"A walking test"},{"outcome_type":"secondary","measure":"Obstacle crossing with and without dual-task","time_frame":"week 16","description":"A walking test"},{"outcome_type":"secondary","measure":"Mini-Balance Evaluations Systems Test","time_frame":"week 0","description":"A balance test"},{"outcome_type":"secondary","measure":"Mini-Balance Evaluations Systems Test","time_frame":"week 8","description":"A balance test"},{"outcome_type":"secondary","measure":"Mini-Balance Evaluations Systems Test","time_frame":"week 16","description":"A balance test"},{"outcome_type":"secondary","measure":"Activities-specific balance confidence scale","time_frame":"week 0","description":"A questionnaire"},{"outcome_type":"secondary","measure":"Activities-specific balance confidence scale","time_frame":"week 8","description":"A questionnaire"},{"outcome_type":"secondary","measure":"Activities-specific balance confidence scale","time_frame":"week 16","description":"A questionnaire"},{"outcome_type":"secondary","measure":"Stroke Specific Quality of Life Scale","time_frame":"week 0","description":"A questionnaire"},{"outcome_type":"secondary","measure":"Stroke Specific Quality of Life Scale","time_frame":"week 8","description":"A questionnaire"},{"outcome_type":"secondary","measure":"Stroke Specific Quality of Life Scale","time_frame":"week 16","description":"A questionnaire"},{"outcome_type":"secondary","measure":"Chedoke Arm and Hand Activity Inventory","time_frame":"week 8","description":"An arm function test"},{"outcome_type":"secondary","measure":"Chedoke Arm and Hand Activity Inventory","time_frame":"week 16","description":"An arm function test"},{"outcome_type":"secondary","measure":"Frenchay Activities Index","time_frame":"week 0","description":"A questionnaire"},{"outcome_type":"secondary","measure":"Frenchay Activities Index","time_frame":"week 8","description":"A questionnaire"},{"outcome_type":"secondary","measure":"Frenchay Activities Index","time_frame":"week 16","description":"A questionnaire"},{"outcome_type":"secondary","measure":"Tinetti Assessment Tool (Gait)","time_frame":"week 0","description":"A walking test"},{"outcome_type":"secondary","measure":"Tinetti Assessment Tool (Gait)","time_frame":"week 8","description":"A walking test"},{"outcome_type":"secondary","measure":"Tinetti Assessment Tool (Gait)","time_frame":"week 16","description":"A walking test"},{"outcome_type":"secondary","measure":"Incidence of fall","time_frame":"week 0-6 months after training","description":"fall follow-up using log book and monthly telephone calls"},{"outcome_type":"secondary","measure":"Global Rating of Change score","time_frame":"week 8","description":"A questionnaire"},{"outcome_type":"secondary","measure":"Global Rating of Change score","time_frame":"week 16","description":"A questionnaire"},{"outcome_type":"secondary","measure":"Upper limb muscle strength","time_frame":"week 0","description":"dynamometry test"},{"outcome_type":"secondary","measure":"Upper limb muscle strength","time_frame":"week 8","description":"dynamometry test"},{"outcome_type":"secondary","measure":"Upper limb muscle strength","time_frame":"week 16","description":"dynamometry test"}]}
{"nct_id":"NCT02228174","start_date":"2014-10-31","phase":"N/A","enrollment":147,"brief_title":"Sonography Guided Transcervical Ablation of Uterine Fibroids","official_title":"Evaluation of the Gynesonics System for Transcervical Treatment of Symptomatic Uterine Fibroids With Radiofrequency Ablation Under Integrated Intrauterine Sonography Guidance","primary_completion_date":"2017-10-18","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-11-30","last_update":"2020-02-11","description":"The objective of this study is to establish the safety and effectiveness of the Sonata System in the treatment of symptomatic uterine fibroids.","other_id":"CL04502","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":25,"maximum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  premenopausal\r\n\r\n          -   25 and  50 years of age at time of enrollment\r\n\r\n          -  experienced heavy menstrual bleeding associated with fibroids (AUB-L) for at least 3\r\n             months\r\n\r\n          -  between 1-10 fibroids of FIGO types 1, 2, 3, 4, and/or type 2-5, with diameter  1.0\r\n             cm and  5.0 cm\r\n\r\n          -  at least one type 1, type 2, type 3, or type 2-5 fibroid.\r\n\r\n          -  PBAC score  150 and  500\r\n\r\n          -  consistent menstrual cycles\r\n\r\n          -  not at material risk for pregnancy\r\n\r\n          -  speaks and reads a language for which validated questionnaires are available\r\n\r\n          -  willing and able to read, understand, and sign the informed consent form, to\r\n             participate in the study and to adhere to all study follow-up requirements\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  pregnancy\r\n\r\n          -  urgent need for surgery to treat fibroid symptoms\r\n\r\n          -  desire for current or future childbearing\r\n\r\n          -  presence of a tubal implant for sterilization\r\n\r\n          -  postmenopausal by history\r\n\r\n          -  presence of type 0 fibroids, unless < 1 cm in diameter\r\n\r\n          -  presence of a single polyp  1.5 cm, or multiple polyps of any size\r\n\r\n          -  any fibroid of FIGO type 1, type 2, type 3, type 4, or type 2-5 with diameter > 5.0 cm\r\n\r\n          -  bulk symptoms in the presence of one or more fibroids of FIGO type 5, type 6, or type\r\n             7\r\n\r\n          -  exclusive presence of fibroids that are insufficient to explain the severity of\r\n             symptoms\r\n\r\n          -  presence of clinically relevant fibroids that cannot be treated for technical reasons\r\n\r\n          -  presence of an extrauterine pelvic mass that has not been diagnosed as benign\r\n\r\n          -  IUD/IUS in situ within the washout period\r\n\r\n          -  previous procedure for fibroids or heavy menstrual bleeding other than myomectomy\r\n\r\n          -  myomectomy within 12 months\r\n\r\n          -  any abnormality of the endometrial cavity that obstructs access of the handpiece\r\n\r\n          -  contraindication to MRI\r\n\r\n          -  total uterine volume > 1000 cc\r\n\r\n          -  clinically significant adenomyosis\r\n\r\n          -  confirmed or suspected diagnosis of clinically relevant endometriosis\r\n\r\n          -  one or more clinically relevant fibroids that are significantly calcified.\r\n\r\n          -  previous pelvic irradiation\r\n\r\n          -  renal insufficiency [serum creatinine  1.5 mg/dL (132.6 mol/L)]\r\n\r\n          -  evidence of disorders of hemostasis (AUB-C)\r\n\r\n          -  abnormal cervical cytology that is unevaluated or untreated in adherence with national\r\n             guidelines\r\n\r\n          -  endometrial hyperplasia (AUB-M), including simple hyperplasia without atypia\r\n\r\n          -  confirmed abdominal / pelvic malignancy within the previous five years\r\n\r\n          -  active pelvic infection or current positive testing for pelvic gonorrhea or chlamydia;\r\n\r\n          -  use of a hormonally-relevant medication within the washout period\r\n\r\n          -  use of an antifibrinolytic agent while undergoing any screening procedures\r\n\r\n          -  current use of anticoagulant therapy\r\n\r\n          -  chronic pelvic pain (disruptive for at least six months) or significant baseline\r\n             pelvic or menstrual pain\r\n\r\n          -  chronic uncontrolled moderate and severe hypertension\r\n\r\n          -  hypoplastic or otherwise short uterus\r\n\r\n          -  major medical or psychiatric illness or other factors that may affect general health\r\n             or subject's ability to adhere to the follow-up schedule or provide valid subject\r\n             self-assessment data\r\n\r\n          -  any other reason for which the individual study subject is not appropriate or suitable\r\n             for participation\r\n      ","sponsor":"Gynesonics","sponsor_type":"Industry","conditions":"Menorrhagia","interventions":[{"intervention_type":"Device","name":"Device: Intrauterine Ultrasound-Guided Radiofreq. Ablation System","description":"The Sonata System combines intrauterine ultrasound (IUUS) with radiofrequency (RF) ablation in a single handpiece. Sonata is suitable in an inpatient or outpatient setting, and is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding(HMB)."}],"outcomes":[{"outcome_type":"secondary","measure":"Pregnancy Outcome - Birth Weight","time_frame":"24 Months","description":"If pregnancy occurred during the study follow-up period, information regarding birth weight was collected."},{"outcome_type":"primary","measure":"Percentage of Subjects With ≥ 50% Reduction in Menstrual Blood Loss as Assessed by Pictorial Blood Loss Assessment Chart (PBAC)","time_frame":"Baseline and 12 Months","description":"The proportion of subjects with a minimum of 50% reduction in menstrual blood loss at 12 months post-procedure compared to baseline as assessed by PBAC. Success for individual subjects was defined as a ≥ 50% reduction from baseline in menstrual blood loss and a final PBAC score < 250. Endpoint success was defined as the lower confidence limit of the percentage of subject success ≥ 45%. The PBAC is a validated tool used to diagnose heavy menstrual bleeding and track menstrual bleeding. Women were asked to record daily use of tampons and sanitary towels by placing a tally mark under the day next to the box that represented how stained the sanitary materials were each time they were changed during the menstrual cycle. The tally marks were added up depending on the saturation level to provide a score. The score does not have an upper limit as it is not a \"scale\". PBAC ≥ 150 is associated with heavy menstrual bleeding."},{"outcome_type":"primary","measure":"Percentage of Subjects Without Surgical Re-intervention for Heavy Menstrual Bleeding Due to Treatment Failure","time_frame":"12 Months","description":"This endpoint computed the rate of not having a surgical reintervention for heavy menstrual bleeding due to treatment failure. As the success criterion for this endpoint was \"no surgical reintervention for HMB due to treatment failure at 12 months\", the endpoint assessed the rate of subjects without surgical reintervention success due to treatment failure within the 12-month post-treatment period. Rate was calculated using the life-table method."},{"outcome_type":"secondary","measure":"Safety - Percentage of Subjects With Adverse Device Effects (Serious or Non-serious)","time_frame":"Each Follow-up Visit through 24 Months","description":"Procedure safety was assessed by recording all adverse device effects that occured during or subsequent to treatment on the day of the procedure. Longer-term safety was assessed by recording any untoward medical occurrence since baseline at each follow-up visit."},{"outcome_type":"secondary","measure":"Percentage Change in Total and Perfused Mean Maximal Fibroid Volumes at 12 Months","time_frame":"Baseline and 12 Months","description":"The percent change in total and perfused volume of dominant fibroid were determined by comparing contrast-enhanced MRI at baseline and at 12 months."},{"outcome_type":"secondary","measure":"Change in the Symptom Severity Score (SSS) and Quality of Life (HR-QoL) Subscales of the Uterine Fibroid Symptom and Quality of Life (UFS-QoL) Questionnaire at 12 Months","time_frame":"Baseline and 12 Months","description":"The Symptom Severity Score (SSS) and Health-Related Quality of Life Score (HR-QoL) are calculated from a subset of the Uterine Fibroid Symptom and Quality of Life (UFS-QoL) questionnaire, a validated and fibroid-specific assessment tool. The UFS-QoL is a uterine fibroid-specific questionnaire developed to evaluate the symptoms of uterine fibroids and their impact on quality of life related to health. SSS and HR-QoL subscale scores are summed and transformed into a 0-100 point scale. The SSS and HR-QoL subscale scores are inversely related with higher SSS indicating greater symptoms while higher HR-QoL scores indicate better quality of life."},{"outcome_type":"secondary","measure":"Time to Return to Normal Activity (RTNA) in Days","time_frame":"30 Day post-procedure","description":"Subjects were given a questionnaire at discharge and asked to daily respond to the questionnaire on whether or not they returned to normal activities."},{"outcome_type":"secondary","measure":"Overall Treatment Effect (OTE) at 12 Months","time_frame":"12 Months","description":"The Overall Treatment Effect is a questionnaire for subjects to report their perceived treatment benefit at a given timepoint as either improved, no change, or worsened."},{"outcome_type":"secondary","measure":"Subject Satisfaction With Treatment at 12 Months","time_frame":"12 Months","description":"Subjects were asked to rate their level of satisfaction with the treatment. The possible ratings were as follows: \"very satisfied\", \"moderately satisfied\", \"somewhat satisfied\", \"somewhat dissatisfied\", \"moderately dissatisfied\", and \"very dissatisfied\"."},{"outcome_type":"secondary","measure":"Subject Willingness to Recommend Procedure at 12 Months","time_frame":"12 Months","description":"Subjects were asked whether they would recommend the procedure to a friend with the same health problems. The possible responses were: \"definitely yes\", \"probably yes\", \"probably no\", and \"definitely no\"."},{"outcome_type":"secondary","measure":"Change in General Health State at 12 Months","time_frame":"Baseline and 12 Months","description":"Change in general health state was assessed with the EuroQOL EQ-5D. The EQ-5D is a standardized instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments, EuroQOL EQ-5D provides a simple descriptive profile and a single index value for health status. The EQ-5D consists of five questions that provide a description of the patient's health state with scores ranging from 0 (indicating death) to 1 (indicating perfect health). An increase of 0.04 in EQ-5D is considered by health economists to represent a minimally important difference."},{"outcome_type":"secondary","measure":"Subject Pain","time_frame":"Immediately Post-procedure as well as Pre-discharge (Day 0)","description":"Prior to discharge, subjects were asked to rate their experience of pain using a pain Visual Analog Scale (VAS). The VAS for pain is a measurement instrument by which subjects report the intensity of their pain with a quantitative value from 0 (no pain) to 10 (worst pain ever)."},{"outcome_type":"secondary","measure":"Procedure Tolerance","time_frame":"Post-procedure (Day 0)","description":"Prior to discharge, subjects were asked to rate their tolerance of the procedure. The possible responses were \"very tolerable\", \"moderately tolerable\", \"minimally tolerable\", \"intolerable\"."},{"outcome_type":"secondary","measure":"Mean Length of Stay","time_frame":"Day 0 - Day of Treatment","description":"Length of stay (in hours) was assessed by recording the duration from the start of the procedure to discharge."},{"outcome_type":"secondary","measure":"Occurrence of Pregnancy","time_frame":"All Follow-up Visits through 24 Months","description":"Subjects were asked about the possible occurrence of pregnancy."},{"outcome_type":"secondary","measure":"Pregnancy Outcome - Gestation Age","time_frame":"24 Months","description":"If pregnancy occurred during the study follow-up period, information regarding gestation age was collected."},{"outcome_type":"secondary","measure":"Change in Work Productivity and Activity Impairment Due to Uterine Fibroid Symptoms at 12 Months","time_frame":"Baseline and 12 Months","description":"The Work Productivity and Activity Impairment questionnaire for a specific health problem (WPAI:SHP) is a standardized instrument for making a quantitative assessment of work impairment and activity impairment attributable to a specific health problem (WPAI:SHP). The assessments are expressed in percentages. The endpoint assessed the difference in these percentages from baseline to 12 months."}]}
{"nct_id":"NCT02260388","start_date":"2014-10-31","phase":"Phase 4","enrollment":402,"brief_title":"Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations","official_title":"Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations (PAIN-CONTRoLS)","primary_completion_date":"2017-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-09-30","last_update":"2018-07-06","description":"The purpose of this large comparative effectiveness study led by Richard J. Barohn, MD, of the University of Kansas Medical Center, is to learn about the safety and effectiveness of nortriptyline, duloxetine, pregabalin and mexiletine in treating cryptogenic sensory polyneuropathy (CSPN).","other_id":"STUDY00001500","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":30,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosis of cryptogenic sensory polyneuropathy.\r\n\r\n          -  Likert Pain Score of greater than or equal to 4.\r\n\r\n          -  Must not currently be on nortriptyline, duloxetine, pregabalin or mexiletine or\r\n             similar class of medication for at least 7 days from baseline study visit.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any medical condition or current medication that would prevent them from taking either\r\n             nortriptyline, duloxetine, pregabalin or mexiletine.\r\n\r\n          -  Unable to give consent.\r\n\r\n          -  Unable or not willing to comply with the study.\r\n\r\n          -  Other causes for polyneuropathy.\r\n      ","sponsor":"University of Kansas Medical Center","sponsor_type":"Other","conditions":"Cryptogenic Sensory Polyneuropathy","interventions":[{"intervention_type":"Drug","name":"Drug: Nortriptyline"},{"intervention_type":"Drug","name":"Drug: Duloxetine"},{"intervention_type":"Drug","name":"Drug: Pregabalin"},{"intervention_type":"Drug","name":"Drug: Mexiletine"}],"outcomes":[{"outcome_type":"primary","measure":"Co-Primary Measures: Percent of Patients With at Least a 50% Decrease in Likert Pain Scale From Baseline to Week 12 Follow Up and Percent of Patients That Quit","time_frame":"12 weeks","description":"The final outcome of the study is a combination of two endpoints, efficacy and quit or treatment discontinuation rates. The first endpoint was a patient responder-defined measure of efficacy. A patient was deemed efficacious if a 50% or more reduction was observed in the Likert pain-scale from the baseline visit to the 12 week visit (i.e. 6 at baseline to 3 or less at week 12). The second endpoint was the observed percentage of patients who discontinued treatment prior to the last follow up visit for any reason or were lost to follow up. The utility function, which combines efficacy and quit rates, was used to drive the adaptive randomization, stopping criteria, and final analysis conclusions."},{"outcome_type":"secondary","measure":"SF12 Health Composite Scores","time_frame":"12 weeks","description":"SF-12v2® Health Survey Standard The Optum™ SF-12v2® Health Survey is a shorter version of the SF-36v2® Health Survey that uses just 12 questions to measure functional health and well-being from the patient's point of view.\r\nSurvey provides psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores.\r\nScores are calibrated so that 50 is the average score or norm, standard deviation = 10.\r\nHigher scores indicate better health for both mental and physical component summary scores."},{"outcome_type":"secondary","measure":"PROMIS Pain Interference Short Form v1.0 8a T Score","time_frame":"12 weeks","description":"Higher scores for pain interference represents worse outcome (more pain interference) T-score metric: 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.\r\nOn the T-score metric: A score of 40 is one SD lower than the mean of the reference population; A score of 60 is one SD higher than the mean of the reference population."},{"outcome_type":"secondary","measure":"PROMIS Fatigue Short Form v1.0 8a","time_frame":"12 Weeks","description":"Higher scores for fatigue represents worse outcome (more fatigue). T-score metric: 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.\r\nOn the T-score metric: A score of 40 is one SD lower than the mean of the reference population; A score of 60 is one SD higher than the mean of the reference population."},{"outcome_type":"secondary","measure":"PROMIS Sleep Disturbance Short Form v1.0 8a","time_frame":"12 weeks","description":"Higher scores for sleep disturbance represents worse outcome (more sleep disturbance).\r\nT-score metric: 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.\r\nOn the T-score metric: A score of 40 is one SD lower than the mean of the reference population; A score of 60 is one SD higher than the mean of the reference population.\r\nHigher scores equals more of the concept being measured"}]}
{"nct_id":"NCT02228655","start_date":"2014-10-31","phase":"Early Phase 1","enrollment":2,"brief_title":"An Exploratory Study to Evaluate FMX-8 to Treat Anemia in CKD","official_title":"An Exploratory, Uncontrolled, Open-labeled Trial to Evaluate the Effect of FMX-8 Treatment for Anemia in Patients With Chronic Kidney Disease (CKD), Stage 4 or 5","primary_completion_date":"2015-04-30","study_type":"Interventional","rec_status":"Terminated","completion_date":"2015-07-31","last_update":"2016-02-02","description":"FMX-8 is a new type of drug being tested for the treatment of anemia in chronic illnesses.","other_id":"FX-C-888","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  a documented hemoglobin level to be less than 10 g/dL at screening\r\n\r\n          -  diagnoses of CKD 4 or 5\r\n\r\n          -  body mass index (BMI) between 18 kg/m2 and 42 kg/m2, inclusive, based upon the height\r\n             and weight at screening\r\n\r\n          -  ferritin levels 100 ng/ml or Tsat 20% at screening\r\n\r\n          -  erythropoietin (EPO) level greater than 8 ng/mL\r\n\r\n          -  able to provide written informed consent\r\n\r\n          -  able to understand and follow all trial procedures\r\n\r\n          -  willing to use contraception as detailed in the protocol\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  receipt of red blood cell (RBC) transfusion within four weeks before screening\r\n\r\n          -  overt gastrointestinal bleeding or other bleeding episode that required transfusion\r\n             within 2 months prior to screening\r\n\r\n          -  infection necessitating antibiotic or anti-viral treatment within a month prior to\r\n             screening\r\n\r\n          -  requiring Coumadin (warfarin), Pradaxa, Eliquis, or Xarelto\r\n\r\n          -  hemoglobinopathies such as homozygous sickle-cell disease or thalassemias of all types\r\n\r\n          -  active hemolysis or chronic hypoxia\r\n\r\n          -  active malignant diseases (except non-melanoma skin cancer) or life expectancy less\r\n             than 6 months\r\n\r\n          -  chronic, uncontrolled or symptomatic inflammatory disease or non-renal cause of anemia\r\n             such as rheumatoid arthritis, systemic lupus erythematosus, HIV, or systemic acute\r\n             infection\r\n\r\n          -  on immunosuppressive therapeutics except topical corticosteroids or nasal sprays\r\n\r\n          -  chronic congestive heart failure (New York Heart Association Class III, IV)\r\n\r\n          -  significant hypertension (90 diastolic) based on a sitting diastolic blood pressure\r\n             at screening\r\n\r\n          -  kidney transplant within the past year: patients who are off immunosuppressive agents\r\n             following a failed transplant are eligible for the trial\r\n\r\n          -  end-stage liver disease\r\n\r\n          -  known hypersensitivity to recombinant protein therapies\r\n\r\n          -  female patients who are pregnant or breast feeding\r\n\r\n          -  previous exposure to FMX-8\r\n\r\n          -  previous exposure to Epogen, Procrit (erythropoietin) Aranesp (darbepoietin alpha),\r\n             Omontys or Hematide (peginesatide) anemia treatment\r\n\r\n          -  uncontrolled hyperparathyroidism (PTH >750) based upon latest PTH determination within\r\n             the past 4 months\r\n\r\n          -  inability to comply with the trial scheduled visits\r\n      ","sponsor":"FerruMax Pharmaceuticals, Inc.","sponsor_type":"Industry","conditions":"Anemia in Chronic Kidney Disease","interventions":[{"intervention_type":"Drug","name":"Drug: FMX-8"}],"outcomes":[{"outcome_type":"primary","measure":"Change in hemoglobin concentration","time_frame":"57 day evaluation period"}]}
{"nct_id":"NCT02091206","start_date":"2014-10-22","phase":"Phase 2","enrollment":34,"brief_title":"A Dose-ranging Pharmacokinetics and Safety Study of GWP42003-P in Children With Dravet Syndrome (GWPCARE1)","official_title":"A Double Blind, Placebo-controlled, Two-part Study to Investigate the Dose-ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome","primary_completion_date":"2015-03-09","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-03-09","last_update":"2018-08-24","description":"To evaluate the safety and pharmacokinetics (PK) of multiple doses of GWP42003-P compared with placebo in children with Dravet syndrome.","other_id":"GWEP1332 Part A","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":4,"maximum_age":10,"population":"","criteria":"\n        Key Inclusion Criteria:\r\n\r\n          -  Participants were male or female aged between 4 and 10 years (inclusive).\r\n\r\n          -  Participants had a documented history of Dravet Syndrome that was not completely\r\n             controlled by AEDs.\r\n\r\n          -  Participants took one or more AEDs at a dose which had been stable for at least 4\r\n             weeks.\r\n\r\n          -  Participants had experienced fewer than 4 convulsive seizures (tonic-clonic, tonic,\r\n             clonic, atonic seizures) during the 28-day baseline period.\r\n\r\n          -  All medications or interventions for epilepsy (including ketogenic diet and vagus\r\n             nerve stimulation [VNS]) were stable for four weeks prior to screening and\r\n             participants were willing to maintain a stable regimen throughout the study. The\r\n             ketogenic diet and VNS treatments were not counted as an AED.\r\n\r\n        Key Exclusion Criteria:\r\n\r\n          -  Participants had clinically significant unstable medical conditions other than\r\n             epilepsy.\r\n\r\n          -  Participants had clinically relevant abnormalities in the 12-lead electrocardiogram\r\n             measured at screening or randomization.\r\n\r\n          -  Participants were currently using or had in the past used recreational or medicinal\r\n             cannabis, or synthetic CBD based medications (including Sativex) within the 3 months\r\n             prior to study entry and were unwilling to abstain for the duration for the study.\r\n\r\n          -  Participants had any known or suspected hypersensitivity to cannabinoids or any of the\r\n             excipients of the IMP.\r\n\r\n          -  Participants who had been part of a clinical trial involving another investigational\r\n             product in the previous 6 months.\r\n\r\n          -  There were plans for the participants to travel outside their country of residence\r\n             during the study.\r\n\r\n          -  Participants were previously randomized into this study. In particular, participants\r\n             participating in Part A of the study cannot enter Part B.\r\n      ","sponsor":"GW Research Ltd","sponsor_type":"Industry","conditions":"Epilepsy|Dravet Syndrome","interventions":[{"intervention_type":"Drug","name":"Drug: GWP42003-P 5 mg/kg/day Dose","description":"GWP42003-P was an oral solution containing 25 mg/milliliter (mL) cannabidiol (CBD) or 100 mg/mL CBD dissolved in the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL). Participants were randomly assigned to receive either 5, 10 or 20 mg/kg/day."},{"intervention_type":"Drug","name":"Drug: Placebo control","description":"Placebo oral solution contained the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL)."},{"intervention_type":"Drug","name":"Drug: GWP42003-P 10 mg/kg/day Dose","description":"GWP42003-P was an oral solution containing 25 mg/mL CBD or 100 mg/mL CBD dissolved in the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL). Participants were randomly assigned to receive either 5, 10 or 20 mg/kg/day."},{"intervention_type":"Drug","name":"Drug: GWP42003-P 20 mg/kg/day Dose","description":"GWP42003-P was an oral solution containing 25 mg/mL CBD or 100 mg/mL CBD dissolved in the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL). Participants were randomly assigned to receive either 5, 10 or 20 mg/kg/day."}],"outcomes":[{"outcome_type":"primary","measure":"Number Of Participants Who Experienced Severe Treatment-Emergent Adverse Events (TEAEs)","time_frame":"Baseline (Day 1) through Safety follow-up visit (Day 60)","description":"A TEAE was defined as an adverse event (AE) with an onset date on or after the first dose of IMP. If an AE had a partial onset date and it was unclear from the partial date (or the stop date) whether the AE started prior to or following the first dose of IMP then the AE was considered a TEAE. The number of participants who experienced one or more severe TEAEs after dosing on Day 1 through the Safety Follow-up Visit (Day 60) is presented.\r\nA summary of serious and all other non-serious AEs regardless of causality is located in the Adverse Events module."},{"outcome_type":"secondary","measure":"Area Under The Concentration-Time Curve Calculated To The Last Observable Concentration At Time T (AUC0-t) For CBD And Its Metabolites At Days 1 And 22","time_frame":"Predose and 2-6 hours postdose on Days 1 and 22","description":"AUC0-t for CBD and its major metabolites, 6-hydroxy-CBD (6-OH-CBD), 7-hydroxy-CBD (7-OH-CBD), and 7-carboxy-CBD (7-COOH-CBD) were calculated using blood samples collected before and after IMP dosing on Days 1 and 22. One sample was collected predose, 2 to 3 hours postdose, and 4 to 6 hours postdose for CBD and its metabolites. Results are presented for participants who received GWP42003-P at 5, 10, or 20 mg/kg/day during the study and for participants with a numeric result for the given evaluation."},{"outcome_type":"secondary","measure":"Mean Percentage Change From Baseline To End Of Treatment In Plasma Clobazam (CLB) And N-Desmethylclobazam (N-CLB) Concentrations","time_frame":"Predose on Days 1 and 22","description":"Plasma concentrations of CLB and N-CLB were measured on Days 1 and 22. Participants were instructed to take their daily dose of CLB 2 hours prior to the anticipated pre-IMP blood specimen collection on both days. Blood samples were collected prior to administration of IMP. Results are presented for a subgroup of participants who took CLB during the study and had PK samples analyzed at both PK sampling visits (Days 1 and 22)."}]}
{"nct_id":"NCT02260921","start_date":"2014-10-20","phase":"N/A","enrollment":180,"brief_title":"Study to Evaluate the Iovera Device for Temporary Relief From Knee Pain","official_title":"A Multi-Center, Prospective, Double-Blind, Randomized Controlled Study to Evaluate the Effectiveness and Safety of the Iovera Device for the Temporary Relief of Pain Associated With Knee Osteoarthritis","primary_completion_date":"2016-02-29","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-05-31","last_update":"2021-02-02","description":"This purpose of this study is to evaluate the effectiveness and safety of the iovera device for the temporary reduction of pain associated with knee osteoarthritis.","other_id":"MYO-0946","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":35,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  35 - 75 years of age\r\n\r\n          -  American College of Rheumatology (ACR) criteria for osteoarthritis of the knee. This\r\n             includes radiographic evidence of osteophytes and at least one of the following: age \r\n             50 years old, morning stiffness  30 minute duration or crepitus on motion.\r\n\r\n          -  Grade II or III osteoarthritis of the knee as determined by Kellgren-Lawrence\r\n             classification grading scale on anteroposterior (AP) x-ray within previous 6 months.\r\n\r\n          -  Participants are ambulatory without assistive devices.\r\n\r\n          -  Knee pain of  40 mm on Visual Analog Scale (VAS) when performing one of two movements\r\n             that elicit the worst pain: standing from a seated position or walking up/down stairs.\r\n\r\n          -  Participant reports knee pain in the anterior and/or inferior aspect of the knee as\r\n             documented on the knee pain map in the appropriate areas.\r\n\r\n          -  A diagnostic lidocaine (without epinephrine) block of the infrapatellar branch of the\r\n             saphenous nerve results in a 50% reduction in the VAS pain assessment score when\r\n             performing the activity that elicits the worst pain: standing from a seated position\r\n             or walking up/down stairs.\r\n\r\n          -  Participant is able to tolerate a washout of prescription and over-the-counter pain\r\n             relief for a duration of 5 times the half-life of the medication prior to the Baseline\r\n             visit.\r\n\r\n        Participant is able to tolerate a washout of adjunctive therapies for knee pain for 72\r\n        hours prior to the Baseline visit.\r\n\r\n          -  Western Ontario and McMaster Osteoarthritis Index (WOMAC) NRS3.1 Pain subscore  20 at\r\n             Baseline/Visit 2.\r\n\r\n          -  Participant is able to tolerate discontinuation of all pain medication throughout the\r\n             duration of the study. Acetaminophen may be used as rescue medication with a maximum\r\n             dose of 4g per day.\r\n\r\n          -  Participant is able to tolerate discontinuation of rescue medication, acetaminophen,\r\n             for 24 hours prior to all follow-up visits.\r\n\r\n          -  Prescription and over-the-counter pain medications must be maintained on a stable\r\n             schedule for at least two weeks prior to screening.\r\n\r\n          -  Participant is willing and able to give written informed consent.\r\n\r\n          -  Participant is willing and able to comply with study instructions and commit to all\r\n             follow-up visits for the duration of the study.\r\n\r\n          -  Participant is in good general health and free of any systemic disease state or\r\n             physical condition that might impair evaluation or which in the Investigator's\r\n             opinion, exposes the Participant to an unacceptable risk by study participation.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of a partial or full knee replacement of the knee to be treated.\r\n\r\n          -  Planned partial or full knee replacement within the next 12 months in knee to be\r\n             treated.\r\n\r\n          -  Previous myoscience Focused Cold Therapy^TM (FCTTM) treatment.\r\n\r\n          -  Viscosupplementation within the previous 6 months in knee to be treated.\r\n\r\n          -  Participant reports the majority of knee pain outside of the anterior/inferior aspect\r\n             of the knee.\r\n\r\n          -  Intra-articular steroid injection in the knee to be treated within previous 3 months.\r\n\r\n          -  Gross deformity of the knee including varus or valgus.\r\n\r\n          -  Started physical therapy of the knee to be treated within 3 months of screening.\r\n\r\n          -  Received acupuncture for knee pain within 3 months prior to screening.\r\n\r\n          -  Body Mass Index  35.\r\n\r\n          -  Prior surgery in the treatment area that may alter the anatomy of the infrapatellar\r\n             branch of the saphenous nerve or result in scar tissue in the treatment area.\r\n\r\n          -  Open and/or infected wound in the treatment area.\r\n\r\n          -  Disease of the spine, hip, contralateral knee or other lower extremity joint of\r\n             sufficient degree affecting the assessment of the treated knee.\r\n\r\n          -  Acetaminophen intolerance or allergy.\r\n\r\n          -  Allergy to lidocaine.\r\n\r\n          -  History of cryoglobulinemia\r\n\r\n          -  History of paroxysmal cold hemoglobinuria.\r\n\r\n          -  History of cold urticaria.\r\n\r\n          -  History of Raynaud's disease.\r\n\r\n          -  History of pes anserinus bursitis in the knee to be treated.\r\n\r\n          -  Use of extended-release or long-acting opioids within previous 3 months.\r\n\r\n          -  Use of immediate-release opioids for more than 3 days per week within previous month.\r\n\r\n          -  Participant is pregnant or planning to become pregnant while enrolled in the study.\r\n\r\n          -  Current enrollment in any investigational drug or device study or participation within\r\n             30 days prior to screening.\r\n\r\n          -  Any additional diagnosis that in the opinion of the Investigator directly contributes\r\n             to knee pain.\r\n\r\n          -  Any concomitant inflammatory disease or other condition that affects the joints (e.g.\r\n             rheumatoid arthritis, metabolic bone disease, gout, active infection, etc.)\r\n\r\n          -  Any clotting disorder and/or use of an anticoagulant (e.g., aspirin, warfarin,\r\n             clopidogrel, etc.) within seven (7) days prior to administration of the device.\r\n\r\n          -  Any local skin condition at the treatment site that in the Investigator's opinion\r\n             would adversely affect treatment or outcomes.\r\n\r\n          -  Any chronic medical condition that in the Investigator's opinion would prevent\r\n             adequate participation.\r\n\r\n          -  Any chronic medication use (prescription, over-the-counter, etc.) that in the\r\n             Investigator's opinion would affect study participation or Subject safety.\r\n\r\n          -  For any reason, in the opinion of the Investigator, the Subject may not be a suitable\r\n             candidate for study participation (i.e., history of noncompliance, drug dependency,\r\n             any related knee injury due to a worker's compensation claim, etc.).\r\n\r\n          -  Known liver dysfunction.\r\n      ","sponsor":"Pacira CryoTech, Inc., a wholly owned subsidiary of Pacira BioSciences, Inc.","sponsor_type":"Industry","conditions":"Knee Osteoarthritis","interventions":[{"intervention_type":"Device","name":"Device: iovera"},{"intervention_type":"Device","name":"Device: Sham Comparator"}],"outcomes":[{"outcome_type":"primary","measure":"Absolute Change From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscale Score at Day 30","time_frame":"Baseline to Day 30","description":"The WOMAC is a tri-dimensional, disease-specific, patient-reported outcome measure. It consists of 24 questions [each question is presented in a numerical rating scale format with possible values between 0= No (best) to 10= Extreme (worst)] with 5 questions regarding pain [possible subscale score 0 to 50], 2 questions regarding stiffness [possible subscale score 0 to 20] and 17 questions regarding function difficulty [possible subscale score 0 to 170]. A negative change from Baseline indicates improvement. An Analysis of Covariance (ANCOVA) model was used for analyses."},{"outcome_type":"secondary","measure":"Change From Baseline in Visual Analog Scale (VAS) at Day 30","time_frame":"Baseline to Day 30","description":"VAS pain assessment is a measure of pain intensity. The scale is made up of a 10 centimeter (cm) [100 millimeter (mm)] horizontal line. The far left of the horizontal line is labeled \"no pain\" while the far right of the horizontal line is labeled \"worst imaginable pain\". A negative change from Baseline indicates improvement. An ANCOVA model was used for analyses."},{"outcome_type":"secondary","measure":"Change From Baseline in Total WOMAC Score at Day 30","time_frame":"Baseline to Day 30","description":"The WOMAC is a tri-dimensional, disease-specific, patient-reported outcome measure. It consists of 24 questions [each question is presented in a numerical rating scale format with possible values between 0= No (best) to 10= Extreme (worst)] with 5 questions regarding pain [possible subscale score 0 to 50], 2 questions regarding stiffness [possible subscale score 0 to 20] and 17 questions regarding function difficulty [possible subscale score 0 to 170]. The WOMAC total score was calculated by summing the 3 subscales for a total possible score of 0 to 240. A negative change from Baseline indicates improvement. An ANCOVA model was used for analyses."},{"outcome_type":"secondary","measure":"Change From Baseline in VAS at Day 60","time_frame":"Baseline to Day 60","description":"VAS pain assessment is a measure of pain intensity. The scale is made up of a 10 cm (100 mm) horizontal line. The far left of the horizontal line is labeled \"no pain\" while the far right of the horizontal line is labeled \"worst imaginable pain\". A negative change from Baseline indicates improvement. An ANCOVA model was used for analyses."},{"outcome_type":"secondary","measure":"WOMAC Pain Score Responder Rate at Day 30","time_frame":"Day 30","description":"WOMAC Pain Score Responder Rate is defined as the percentage of participants with at least a 30% reduction in the WOMAC pain score at Day 30 compared to Baseline. WOMAC is a tri-dimensional, disease-specific, patient-reported outcome measure. It consists of 24 questions [each question is presented in a numerical rating scale format with possible values between 0= No to 10= Extreme] with the first 5 questions regarding pain [possible subscale score 0 (best) to 50 (worst)]."},{"outcome_type":"secondary","measure":"VAS Responder Rate at Day 30","time_frame":"Day 30","description":"VAS Responder Rate is defined as the percentage of participants with at least a 30% reduction in VAS at Day 30 compared to Baseline VAS pain assessment is a measure of pain intensity. The scale is made up of a 10 cm (100 mm) horizontal line. The far left of the horizontal line is labeled \"no pain\" while the far right of the horizontal line is labeled \"worst imaginable pain\"."},{"outcome_type":"secondary","measure":"Change From Baseline in Total WOMAC Score at Day 60","time_frame":"Baseline to Day 60","description":"The WOMAC is a tri-dimensional, disease-specific, patient-reported outcome measure. It consists of 24 questions [each question is presented in a numerical rating scale format with possible values between 0= No (best) to 10= Extreme (worst)] with 5 questions regarding pain [possible subscale score 0 to 50], 2 questions regarding stiffness [possible subscale score 0 to 20] and 17 questions regarding function difficulty [possible subscale score 0 to 170]. The WOMAC total score was calculated by summing the 3 subscales for a total possible score of 0 to 240. A negative change from Baseline indicates improvement."},{"outcome_type":"secondary","measure":"VAS Responder Rate at Day 60","time_frame":"Day 60","description":"VAS Responder Rate is defined as the percentage of participants with at least a 30% reduction in VAS at Day 60 compared to Baseline. VAS pain assessment is a measure of pain intensity. The scale is made up of a 10 cm (100 mm) horizontal line. The far left of the horizontal line is labeled \"no pain\" while the far right of the horizontal line is labeled \"worst imaginable pain\"."},{"outcome_type":"secondary","measure":"WOMAC Pain Score Responder Rate at Day 60","time_frame":"Day 60","description":"WOMAC Pain Score Responder Rate is defined as the percentage of participants with at least a 30% reduction in the WOMAC pain score at Day 60 compared to Baseline. WOMAC is a tri-dimensional, disease-specific, patient-reported outcome measure. It consists of 24 questions [each question is presented in a numerical rating scale format with possible values between 0= No (best) to 10= Extreme (worst)] with the first 5 questions regarding pain [possible subscale score 0 to 50]."}]}
{"nct_id":"NCT02179190","start_date":"2014-10-13","phase":"N/A","enrollment":138,"brief_title":"Reverse Medical Barrel Device for Adjunctive Treatment for Wide-Neck, Intracranial, Bifurcating/Branching Aneurysms","official_title":"Prospective, Multi-Center, Single-Arm Study of Reverse Medical Barrel Vascular Reconstruction Device for Adjunctive Treatment to Embolic Coils in Wide-Neck, Intracranial, Bifurcating Aneurysms of Middle Cerebral and Basilar Arteries","primary_completion_date":"2017-07-21","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-07-21","last_update":"2018-12-26","description":"Single arm study to evaluate the outcomes of treatment with the Barrel VRD device as an adjunctive treatment to coiling for wide neck, intracranial, bifurcating/branching aneurysms in the middle cerebral and basilar arteries.","other_id":"VRD-001","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Male or female between 18 and 85 years old.\r\n\r\n          2. A wide-neck de novo or non-de novo aneurysm.\r\n\r\n          3. Appropriate informed consent obtainable as determined by local IRB.\r\n\r\n          4. Life expectancy > 24 months.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Aneurysm rupture within 30 days of enrollment.\r\n\r\n          2. Bifurcating aneurysms not treatable with coiling.\r\n\r\n          3. Subject has platelet count of <70,000.\r\n\r\n          4. Subject has known allergies to nickel-titanium metal.\r\n\r\n          5. Subject has known allergies to aspirin or heparin.\r\n\r\n          6. Subject has a life-threatening allergy to contrast (unless treatment for allergy can\r\n             be tolerated).\r\n\r\n          7. Subject is currently participating in another clinical research study.\r\n\r\n          8. Subject is pregnant or breastfeeding.\r\n\r\n          9. Subject has participated in a drug study within the last 30 days.\r\n\r\n         10. Subject is unable or unwilling to comply with protocol requirements and obtain\r\n             required clinical evaluations and follow-up.\r\n      ","sponsor":"Medtronic Neurovascular Clinical Affairs","sponsor_type":"Industry","conditions":"Intracranial Bifurcating Aneurysms","interventions":[{"intervention_type":"Device","name":"Device: BARREL VRD","description":"The Barrel VRD was implanted as adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries."}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants With Neurologic Death or Major Ipsilateral Stroke Within 12 Month Follow-up Period.","time_frame":"12 months, after device implant","description":"The primary safety endpoint was the number of participants reported with a neurological death or major ipsilateral stroke (National Institute of Stroke Scale (NIHSS) increase of ≥ 4 for > 24 hours) at any time during the follow-up period.\r\nThe NIHSS is a tool used to quantify neurological impairment caused by stroke. The scale interpretation is as follows:\r\n0: No stroke symptoms 1-4: Minor stroke symptoms 5-15: Moderate stroke 16-20: Moderate to severe stroke 21-42: Severe strokeThe National Institutes of Health Stroke Scale"},{"outcome_type":"primary","measure":"Number of Participants With Raymond Grade I ( 100%) Occlusion of the Aneurysms for Participants Treated With the Barrel VRD at 12 Months in the Absence of Retreatment, Parent Artery Stenosis, or Target Aneurysm Rupture","time_frame":"12 months, after device implant","description":"The primary effectiveness endpoint was the count of participants achieving Raymond Grade I (100% occlusion) of the aneurysm treated with the Barrel VRD at 12 months ± 8 weeks in the absence of retreatment, parent artery stenosis (>50%), or target aneurysm rupture\r\nThe Raymond Grade Classification definitions evaluated by an independent core laboratory are as follows:\r\nClass 1: Complete occlusion - complete obliteration of the aneurysm. Class 2: Residual neck - persistence of any portion of the original defect of the arterial wall as seen on any single projection, but without opacification of the aneurysmal sac.\r\nClass 3: Residual aneurysm - opacification of the aneurysmal sac"},{"outcome_type":"secondary","measure":"Number of Participants With Successfully Deployed Barrel VRD","time_frame":"Index Procedure, Day 0","description":"This secondary outcome measure provides the number of subjects successfully implanted with the Barrel VRD."},{"outcome_type":"secondary","measure":"Number of Participants With Raymond Grade I (100% Complete Occlusion) and Raymond Grade II (Residual Neck) for Participants Treated With the Barrel VRD, in the Absence of Retreatment, Parent Artery Stenosis (>50%), or Target Aneurysm Rupture at 12 Months","time_frame":"12 months, after device implant","description":"This secondary outcome measure provides the count of participants treated with the Barrel VRD with Independent Core Laboratory aneurysm occlusion imaging evaluations of Complete Occlusion (Raymond Grade I) and Residual Aneurysm Neck (Raymond Grade II) at 12 months combined. Subjects with evidence of parent artery stenosis, retreatment, or rupture were not considered success.\r\nRaymond Grade Scale\r\nClass 1: Complete occlusion - complete obliteration of the aneurysm. Class 2: Residual neck - persistence of any portion of the original defect of the arterial wall as seen on any single projection, but without opacification of the aneurysmal sac.\r\nClass 3: Residual aneurysm - opacification of the aneurysmal sac."},{"outcome_type":"secondary","measure":"Number of Participants With Modified Rankin Score of 0-2 or no Change From Baseline","time_frame":"12 months, after device implant","description":"This secondary outcome provides the count of participants treated with the Barrel device with a Modified Rankin Score of 0-2 at 12 months or no change from baseline.\r\nThe Modified Rankin Score is a scale for measuring general functionality as follows:\r\n0: No symptoms at all\r\nNo significant disability despite symptoms; able to carry out all usual duties and activities\r\nSlight disability; unable to carry out all previous activities, but able to look after own affairs without assistance\r\nModerate disability; requiring some help, but able to walk without assistance\r\nModerately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance\r\nSevere disability; bedridden, incontinent and requiring constant nursing care and attention\r\nDead"},{"outcome_type":"secondary","measure":"Number of Participants With Angiographic Evidence of In-stent Stenosis at 12 Months +/- 8 Weeks Reported According to the Following Ordinal Groups: <25%, 25-50%, 51-75%, >75%","time_frame":"At 12 Months +/- 8 weeks","description":"This secondary measure provides the count of participants with parent artery stenosis per an independent core lab evaluation within the following ordinal groups: <25%, 25-50%, 51-75%, >75%."},{"outcome_type":"secondary","measure":"Number of Participants With Any Cause of Death Within 30 Days or Neurological Death Within 12 Months +/- 8 Weeks","time_frame":"30 Days and 12 months +/- 8 weeks","description":"This secondary outcome measure provides the combined number and percentage of subjects that died within 30 days or had a neurologic death within 12 months of receiving the study device."},{"outcome_type":"other","measure":"Number of Participants With Reported Device Related Serious Adverse Events","time_frame":"From the point of consent until participant exits the study at 1 year","description":"This secondary outcome measure provides the count of participants reported with a Serious Device Related Adverse Events"}]}
{"nct_id":"NCT02292472","start_date":"2014-10-06","phase":"Phase 2","enrollment":69,"brief_title":"Medytoxin Treatment in Patients With Benign Masseteric Hypertrophy","official_title":"A Randomized, Double-blind, Multi-center, Phase II Optimal Dose-finding Study to Determine Safety and Efficacy of Medytoxin in Subjects in Benign Masseteric Hypertrophy","primary_completion_date":"2015-05-24","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-08-24","last_update":"2019-03-27","description":"This study design is A Randomized, Double-blind, Multi-center, Phase II Optimal Dose-finding Study to Determine the Safety and Efficacy of Meditoxin in Subjects in Benign Masseteric Hypertrophy.","other_id":"MT_PRT_BMH01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":19,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Subject who shows benign masseteric hypertrophy\r\n\r\n          2. Male or female subject over 19 years of age and written informed consent is obtained\r\n             from the patient or LAR.\r\n\r\n          3. Subject who has bisymmetry of masster at visual assessment.\r\n\r\n          4. Subejects who qualifies the standard meets on ultrasonics wave value.\r\n\r\n          5. Subjects who can and will comply with the requirements of the protocol.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Diagnosis of myasthenia, facial palsy or severe facial asymmetry\r\n\r\n          2. Subject who got any treatment, including double jaw surgery, laser, thread treatment\r\n             etc. in 1 year.\r\n\r\n          3. Subject who had previously received botulinum toxin within 3 months prior to the study\r\n             entry\r\n\r\n          4. Subject who is participating in other investigational study at present or 30 prior to\r\n             the screening date.\r\n\r\n          5. Subject with known hypersensitivity to botulinum toxin\r\n\r\n          6. Subject who are pregnant or lactating or found pregnancy though the urine or sebum\r\n             test or disagreed to avoid pregnancy during study preiod.\r\n\r\n          7. Subjects who are not eligible for this study at the discretion of the investigator.\r\n      ","sponsor":"Medy-Tox","sponsor_type":"Industry","conditions":"Hypertrophy of Masseter Muscle","interventions":[{"intervention_type":"Drug","name":"Drug: Botulinum Toxin Type A","description":"Inject intramuscularly once in visit 2"},{"intervention_type":"Drug","name":"Drug: Placebos","description":"Inject intramuscularly once in visit 2"}],"outcomes":[{"outcome_type":"primary","measure":"Reduction amount of masseter muscle thickness","time_frame":"after the injection"},{"outcome_type":"secondary","measure":"Reduction amount of masseter muscle thickness and lower face volume","time_frame":"after the injection"},{"outcome_type":"secondary","measure":"Overall satisfaction of subject","time_frame":"after the injection"}]}
{"nct_id":"NCT04348851","start_date":"2014-10-01","phase":"N/A","enrollment":53,"brief_title":"Internet and Telephone Support Intervention for Stroke Caregivers","official_title":"Internet and Telephone Support Intervention for Stroke Caregivers","primary_completion_date":"2016-09-19","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-10-01","last_update":"2020-06-02","description":"This study will test a problem-solving and support intervention for caregivers of veterans with stroke. The investigators will assign caregivers to one for four groups: 4-session intervention, 8-session intervention, attention control (active listening), or standard care. The investigators will assess the impact of the intervention on caregiver outcomes (depression, burden, stress, problem-solving abilities, self-efficacy, and quality of life) and veteran outcomes (functional abilities).","other_id":"D1395-P","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","intervention_model_description":"Four-arm randomized controlled trial","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        All non-paid caregivers of Veterans with a primary diagnosis of stroke, discharged to home\r\n        from a medical or rehabilitation facility are eligible for participation if they meet the\r\n        following criteria:\r\n\r\n          -  have caregiving responsibility for a Veteran who has a diagnosis of stroke (ICD9 codes\r\n             for stroke: 430-438) within the last 2.5 years and who have at least one activity of\r\n             daily living (ADL), cognitive, or speech deficit related to stroke\r\n\r\n          -  score 1 or greater on the Perceived Stress Scale\r\n\r\n          -  have Internet access and ability\r\n\r\n          -  are reachable by their cell or home phones\r\n\r\n          -  read English at a seventh-grade reading level or better\r\n\r\n          -  agree to random assignment to a study arm\r\n\r\n        Exclusion Criteria:\r\n\r\n        The investigators will exclude caregivers who fail to meet one or more of the inclusion\r\n        criteria and whose Veterans:\r\n\r\n          -  have a life expectancy of less than 6 months\r\n\r\n          -  are receiving hospice/palliative care or are residing in a community living center\r\n\r\n               -  Life expectancy will be determined by reviewing the electronic health record\r\n                  (EHR) and conferring with our physician and clinical team members\r\n      ","sponsor":"VA Office of Research and Development","sponsor_type":"U.S. Fed","conditions":"Depression|Quality of Life|Recovery of Function|Self Efficacy|Stress","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Caregiver problem-solving","description":"Registered nurses will conduct the combined Internet and telephone intervention condition. The intervention is based on the relational/problem-solving model of stress originally developed by D-Zurilla and Nezu. The investigators will modify the traditional, problem-solving intervention by adding web-based training using interactive modules, factsheets, and tools on our national RESCUE Stroke Caregiver website. (http://www.cidrr8.research.va.gov/rescue"},{"intervention_type":"Behavioral","name":"Behavioral: Attention Control","description":"The RNs will only provide active listening and paraphrasing. The RNs will ask caregivers to talk about their caregiver experiences. The nurses will not provide advice, but rather direct caregivers to access information on the Caregiver Family Alliance website (www.caregiver.org) for managing problems or to contact their healthcare"}],"outcomes":[{"outcome_type":"primary","measure":"Change in Depressive Symptoms","time_frame":"9 weeks after baseline","description":"Changes in depressive symptoms will be measured with the Center for Epidemiologic Studies Depression (CES-D) scale. The CES-D is a 20-item, 4-point Likert scale ranging from never (0) to most of the time (3). Possible scores range from 0-60 with higher scores indicating more symptoms. It has been used in numerous studies with caregivers and has good reliability and validity."},{"outcome_type":"primary","measure":"Change in Caregiver Burden","time_frame":"9 weeks after baseline","description":"Changes in burden will be measured by the Short Version of the Zarit Burden Interview (S-ZBI). This 12-item instrument was reduced from the original 29-item instrument. This instrument is scored on a 5-point Likert scale ranging from 0 (never) to 4 (nearly always). Possible scores range from 0-48 with higher scores indicating higher burden. The instrument was originally developed to measure dementia caregiver burden, but, the S-ZBI has been used in stroke caregiver studies and items are appropriate for other caregiver populations."},{"outcome_type":"primary","measure":"Change in Depressive Symptoms","time_frame":"25 weeks after baseline","description":"Change in depressive symptoms will be measured with the Center for Epidemiologic Studies Depression (CES-D) scale. The CES-D is a 20-item, 4-point Likert scale ranging from never (0) to most of the time (3). Possible scores range from 0-60 with higher scores indicating more symptoms. It has been used in numerous studies with caregivers and has good reliability and validity."},{"outcome_type":"primary","measure":"Change in Caregiver Burden","time_frame":"25 weeks after baseline","description":"Changes in burden will be measured by the Short Version of the Zarit Burden Interview. This 12-item instrument was reduced from the original 29-item instrument. This instrument is scored on a 5-point Likert scale ranging from 0 (never) to 4 (nearly always). Possible scores range from 0-48 with higher scores indicating higher burden. The instrument was originally developed to measure dementia caregiver burden, but, the S-ZBI has been used in stroke caregiver studies and items are appropriate for other caregiver populations."},{"outcome_type":"secondary","measure":"Change in Health-Related Quality of Life - Physical Scale","time_frame":"9 weeks after baseline","description":"Changes in health-related quality of life will be measured by the Rand 12-item Health Survey (VR-12). The VR-12 items are scored on a 3-point or 5-point Likert scale ranging from. It consists of physical and emotional scales. Scores for each scale are calculated by using an algorithm and scores are standardized using a T-score metric with a mean of 50 and standard deviation of 10. Higher scores indicate better health-related quality of life."},{"outcome_type":"secondary","measure":"Change in Perceived Stress","time_frame":"9 weeks after baseline","description":"Changes in perceived stress will be measured by the Perceived Stress Scale (PSS-4). The 4-item measure asses stress experienced in the last month on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores range from 0-16, with higher scores indicating more stress."},{"outcome_type":"secondary","measure":"Change in Stroke Knowledge","time_frame":"9 weeks after baseline","description":"Change in stroke knowledge will be measured by the Stroke Knowledge Instrument developed by the National Institutes of Health. This 7-item tool consists of true/false and multiple choice responses. Scores range from 0-7, with higher scores indicating more stroke knowledge."},{"outcome_type":"secondary","measure":"Changes in Problem-Solving Abilities","time_frame":"9 weeks after baseline","description":"Changes in problem-solving abilities will be measured by the Social Problem-Solving Inventory - Short Form (SPSI-SF). The SPSI-SF is a 25-item tool consisting of five subscales (problem-solving orientation, rational problem-solving, negative problem-solving, impulsivity, avoidance style problem solving). Raw scores must first be converted to standard scores, which range from 0-20 for each of the 5 subscales. Higher scores on the problem-solving orientation and rational problem-solving scales indicate better problem-solving abilities, while higher scores on the negative problem-solving, impulsivity, and avoidance-style problem solving indicate worse problem-solving abilities. Total scores range from 0-100 with higher scores indicating better problem-solving abilities."},{"outcome_type":"secondary","measure":"Caregiving Self-efficacy","time_frame":"9 weeks after baseline","description":"Changes in caregiving self-efficacy will be measured by the Caregiver Self-Efficacy Scale. This 14-item tool measures caregivers' judgments regarding their ability to perform effectively. Responses are binary (0=no, 1=yes) and scores range from 0-14, with higher scores indicating greater self-efficacy."},{"outcome_type":"secondary","measure":"Change in Veteran Functional Abilities","time_frame":"9 weeks after baseline","description":"Change in Veteran functional abilities will be measured by the Barthel Index, which measures patients' abilities to perform 10 self-care tasks. Response options vary for each item and are scored on 5-point increments (e.g., 0=unable, 5=needs help, 10-independent). Total scores range from 0-100 with higher scores indicating greater functional abilities."},{"outcome_type":"secondary","measure":"Change in Health-Related Quality of Life - Physical Scale","time_frame":"25 weeks after baseline","description":"Changes in health-related quality of life will be measured by the Rand 12-item Health Survey (VR-12). The VR12 items are scored on a 3-point or 5-point Likert scale ranging from. It consists of physical and emotional scales. Scores for each scale are calculated by using an algorithm and scores are standardized using a T-score metric with a mean of 50 and standard deviation of 10. Higher scores indicate better health-related quality of life."},{"outcome_type":"secondary","measure":"Change in Perceived Stress","time_frame":"25 weeks after baseline","description":"Changes in stress will be measured by the Perceived Stress Scale (PSS-4). The 4-item measure asses stress experienced in the last month on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores range from 0-16, with higher scores indicating more stress."},{"outcome_type":"secondary","measure":"Change in Stroke Knowledge","time_frame":"25 weeks after baseline","description":"Change in stroke knowledge will be measured by the Stroke Knowledge Instrument developed by the National Institutes of Health. This 7-item tool consists of true/false and multiple choice responses. Scores range from 0-7, with higher scores indicating more stroke knowledge."},{"outcome_type":"secondary","measure":"Change in Problem-Solving Abilities","time_frame":"25 weeks after baseline","description":"Changes in problem-solving abilities will be measured by the Social Problem-Solving Inventory - Short Form (SPSI-SF). The SPSI-SF is a 25-item tool consisting of five subscales (problem-solving orientation, rational problem-solving, negative problem-solving, impulsivity, avoidance style problem solving). Raw scores must first be converted to standard scores, which range from 0-20 for each of the 5 subscales. Higher scores on the problem-solving orientation and rational problem-solving scales indicate better problem-solving abilities, while higher scores on the negative problem-solving, impulsivity, and avoidance-style problem solving indicate worse problem-solving abilities. Total scores range from 0-100 with higher scores indicating better problem-solving abilities."},{"outcome_type":"secondary","measure":"Change in Caregiving Self-Efficacy","time_frame":"25 weeks after baseline","description":"Changes in caregiving self-efficacy are measured by the Caregiver Self-Efficacy Scale. This 14-item tool measures caregivers' judgments regarding their ability to perform effectively. Responses are binary (0=no, 1=yes) and scores range from 0-14, with higher scores indicating greater self-efficacy."},{"outcome_type":"secondary","measure":"Change in Veteran Functional Abilities","time_frame":"25 weeks after baseline","description":"Change in Veteran functional abilities will be measured by the Barthel Index, which measures patients' abilities to perform 10 self-care tasks. Response options vary for each item and are scored on 5-point increments (e.g., 0=unable, 5=needs help, 10-independent). Total scores range from 0-100 with higher scores indicating greater functional abilities."},{"outcome_type":"secondary","measure":"Change in Health-Related Quality of Life - Mental Scale","time_frame":"9 weeks after baseline","description":"Changes in health-related quality of life will be measured by the Rand 12-item Health Survey (VR-12). The VR12 items are scored on a 3-point or 5-point Likert scale ranging from. It consists of physical and emotional scales. Scores for each scale are calculated by using an algorithm and scores are standardized using a T-score metric with a mean of 50 and standard deviation of 10. Higher scores indicate better health-related quality of life."},{"outcome_type":"secondary","measure":"Change in Health-Related Quality of Life - Mental Scale","time_frame":"25 weeks after baseline","description":"Changes in health-related quality of life will be measured by the Rand 12-item Health Survey (VR-12). The VR12 items are scored on a 3-point or 5-point Likert scale ranging from. It consists of physical and emotional scales. Scores for each scale are calculated by using an algorithm and scores are standardized using a T-score metric with a mean of 50 and standard deviation of 10. Higher scores indicate better health-related quality of life."}]}
{"nct_id":"NCT02240992","start_date":"2014-09-30","phase":"Phase 2/Phase 3","enrollment":120,"brief_title":"MSCs With or Without Peripheral Blood Stem Cell for Treatment of Poor Graft Function and Delayed Platelet Engraftment","official_title":"Mesenchymal Stem Cells With or Without G-CSF Mobilized Peripheral Blood Stem Cell for Treatment of Poor Graft Function and Delayed Platelet Engraftment After Allogeneic Hematopoietic Stem Cell Transplant","primary_completion_date":"2018-09-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2018-12-31","last_update":"2014-09-16","description":"The purpose of this study is to compare the efficacy of mesenchymal stem cells (MSCs) with or without granulocyte colony-stimulating factor (G-CSF) mobilized peripheral stem cells (PBSC) in treating patients experiencing poor graft function or delayed platelet engraftment after allogeneic hematopoietic stem cell transplantation.","other_id":"NFH-PBSC-MSC-PGF-2014","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":14,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age14-65 years\r\n\r\n          -  PGF or DPE after allo-HSCT\r\n\r\n          -  Subjects (or their legally acceptable representatives) must have signed an informed\r\n             consent document\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood\r\n             pressure)\r\n\r\n          -  Patients with any conditions not suitable for the trial (investigators' decision)\r\n      ","sponsor":"Nanfang Hospital of Southern Medical University","sponsor_type":"Other","conditions":"Stem Cell Transplantation, Hematopoietic|Poor Graft Function|Delayed Platelet Engraftment|Hematological Diseases","interventions":[{"intervention_type":"Biological","name":"Biological: PBSC"},{"intervention_type":"Biological","name":"Biological: MSCs"}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of Participants with Hematopoietic Recovery","time_frame":"1 year","description":"Hematopoietic reconstitution post-transplantation is defined as reconstitution of both neutrophil and platelet numbers. Neutrophil reconstitution is defined as occurring on the first 3 consecutive days with an neutrophil(NEU)>0.5×10^9/L, and platelet (PLT) reconstitution is defined as the first >20×10^9/L for 3 consecutive days."},{"outcome_type":"secondary","measure":"Incidence of graft-versus-host disease","time_frame":"1 year","description":"Graft-versus-host disease (GVHD) includes acute GVHD and chronic GVHD."},{"outcome_type":"secondary","measure":"Incidence of infections","time_frame":"1 year","description":"Infections include bacterial, invasive fungal and viral infections"},{"outcome_type":"secondary","measure":"Incidence of primary underlying disease relapse","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Incidence of acute toxicity","time_frame":"up to 100 days","description":"Acute toxicity mainly involves the heart,live and kidney."}]}
{"nct_id":"NCT02064725","start_date":"2014-09-30","phase":"Phase 2","enrollment":8,"brief_title":"Virexxa (Sodium Cridanimod) w/Progestin Therapy in Pts w/Progesterone Receptor Neg Recurrent/Persistent Endometrial CA","official_title":"A Phase II Study of Sodium Cridanimod in Conjunction With Progestin Therapy in Patients With Progesterone Receptor Negative Recurrent or Persistent Endometrial Carcinoma","primary_completion_date":"2018-01-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2018-07-31","last_update":"2017-01-24","description":"This is an open label, multi-center, single arm phase II study. The study will investigate the efficacy of sodium cridanimod in conjunction with progestin therapy in a population of patients with recurrent or persistent PrR-negative endometrial cancer.","other_id":"VX-EC-2-2013","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Female patients age 18 and older;\r\n\r\n          -  Histologically confirmed papillary serous adenocarcinoma or endometrioid type of\r\n             endometrial carcinoma (histological documentation of recurrence is not required);\r\n\r\n          -  Patient has documented evidence of PrR negative endometrial cancer. PrR negativity can\r\n             be determined by immunohistochemistry. The tumor is considered PrR negative if the\r\n             number of PrR positive cells is less than 1% determined by immunohistochemistry;\r\n\r\n          -  Availability of tumor tissue sample that can be used for assessment of PrR levels with\r\n             the use of immunohistochemistry;\r\n\r\n          -  Recurrent or persistent (after the failure of chemotherapy) disease that cannot be\r\n             treated with surgery or radiotherapy;\r\n\r\n          -  Documented disease progression after a platinum based chemotherapy in patients for\r\n             whom administration of taxanes and anthracyclines is not planned. Progression must\r\n             fulfill one of the following criteria:\r\n\r\n               -  Progression has occurred within 30 days of platinum based chemotherapy consisting\r\n                  of minimum of two cycles of cisplatin-based (60 mg/m2/cycle) or\r\n                  carboplatin-based (300 mg/m2/cycle, or area under the time-concentration curve\r\n                  4) chemotherapy.\r\n\r\n               -  Progression after neoadjuvant or adjuvant platinum based chemotherapy if the\r\n                  recurrence occurred while on neoadjuvant/adjuvant chemotherapy or within 6 months\r\n                  since the last administration of such therapy.\r\n\r\n          -  Measurable disease as defined by RECIST 1.1 criteria;\r\n\r\n          -  At least one \"target lesion\" to be used to assess response, as defined by RECIST 1.1\r\n             criteria;\r\n\r\n          -  Tumors within a previously irradiated field will be designated as \"non-target\" lesions\r\n             unless progression is documented;\r\n\r\n          -  GOG performance status 0-2;\r\n\r\n          -  Glomerular filtration rate  50 mL/min;\r\n\r\n          -  Total bilirubin normal;\r\n\r\n          -  AST  2.5 times upper limit of normal (ULN) ( 5 times ULN for patients with liver\r\n             metastases);\r\n\r\n          -  Alkaline phosphatase  2.5 times ULN ( 5 times ULN for patients with liver\r\n             metastases);\r\n\r\n          -  Albumin  3.0 mg/dL;\r\n\r\n          -  Ability to take oral medication;\r\n\r\n          -  Ability to understand and the willingness to sign a written informed consent document.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Evidence of histology of the tumor other than papillary serous adenocarcinoma or\r\n             endometrioid type of endometrial carcinoma or mixed histology of the tumor;\r\n\r\n          -  History of hormonal therapy for endometrial carcinoma for more than 3 months;\r\n\r\n          -  History of use of progestins for a period of longer than 3 months for any indication,\r\n             including endometriosis;\r\n\r\n          -  Concurrent maintenance corticosteroids;\r\n\r\n          -  Concurrent oral contraceptives/ Fertile patients must use effective barrier\r\n             contraception;\r\n\r\n          -  Pregnancy as determined by pregnancy test or nursing;\r\n\r\n          -  History of bleeding (i.e. disseminated intravascular coagulation or clotting factor\r\n             deficiency);\r\n\r\n          -  Prior major surgery less than 4 weeks prior to the start of the study;\r\n\r\n          -  Concurrent serious illness which, in the opinion of the investigator, would place the\r\n             patient at unreasonable risk from study therapy;\r\n\r\n          -  Previous malignancy less than 3 years ago other than in situ carcinoma of the cervix,\r\n             basal cell carcinoma or squamous carcinoma of the skin;\r\n\r\n          -  History of allergic reactions or idiosyncrasy attributed to progestins or compounds of\r\n             similar chemical structure to sodium cridanimod or lidocaine;\r\n\r\n          -  Known brain metastases;\r\n\r\n          -  Other concurrent investigational agents;\r\n\r\n          -  Other concurrent anticancer therapies.\r\n\r\n          -  Known carrier of HIV.\r\n      ","sponsor":"Kevelt AS","sponsor_type":"Industry","conditions":"Recurrent or Persistent Endometrial Carcinoma","interventions":[{"intervention_type":"Drug","name":"Drug: Sodium cridanimod","description":"Eligible patients will be enrolled into the study and administered sodium cridanimod (500 mg i.m./ twice a week) in combination with megestrol acetate (160 mg p.o./ day) or medroxyprogesterone acetate (200 mg p.o./ day)."}],"outcomes":[{"outcome_type":"secondary","measure":"Time to response","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Time to progression","time_frame":"24 months"},{"outcome_type":"secondary","measure":"Overall survival","time_frame":"24 months"},{"outcome_type":"secondary","measure":"Overall Disease Control Rate","time_frame":"24 months"},{"outcome_type":"other","measure":"Progesterone receptor (PrR) levels","time_frame":"1 months"},{"outcome_type":"primary","measure":"Objective Response Rate","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Progression-free survival","time_frame":"24 months"}]}
{"nct_id":"NCT02221596","start_date":"2014-09-30","phase":"N/A","enrollment":50,"brief_title":"Vitamin D and Muscle Metabolic Function","official_title":"Vitamin D Contribution to Muscle Metabolic Function in Aged Adults","primary_completion_date":"2018-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-03-01","last_update":"2018-03-15","description":"The purpose of this study is to identify the magnitude of muscle lipid redistribution and muscle oxygen use in individuals 60 years old or older following combined treatment of vitamin D repletion and aerobic training compared to vitamin D repletion alone, aerobic training alone, or no treatment.","other_id":"1R21AG046762-01A1","allocation":"Randomized","intervention_model":"Factorial Assignment","primary_purpose":"Other","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age: 60 and older\r\n\r\n          -  BMI: 18.5-29\r\n\r\n          -  Communicates fluently in English\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Metal implant not suitable for MRI\r\n\r\n          -  Any form of hormone replacement therapy\r\n\r\n          -  Engage in more than 1 hr/week of vigorous activity\r\n\r\n          -  Participated in a high-intensity resistance or aerobic training program in the last 3\r\n             months\r\n\r\n          -  Lower extremity injury or surgery in the past 3 months\r\n\r\n          -  Foot sores or bone conditions severely limiting ability to move or perform exercise or\r\n             joint pain made worse by mild exercise\r\n\r\n          -  Diabetes, inflammatory bowel disease, renal disease or uncontrolled hypertension.\r\n\r\n          -  Currently have or had a history of cardiovascular or pulmonary disease that would\r\n             preclude the involvement in the performance of exercise\r\n\r\n          -  History of myopathy (including congenital myopathies)\r\n\r\n          -  History of neurological conditions related to spinal derangement, disk disease,\r\n             peripheral neuropathies, tremor and rigidity\r\n\r\n          -  Past medical history of hyperparathyroidism, kidney stones or rhabdomyolysis\r\n\r\n          -  Currently receiving treatment for vitamin D deficiency\r\n\r\n          -  Vitamin D level >30ng/mL\r\n\r\n          -  Currently smoking\r\n      ","sponsor":"David Travis Thomas","sponsor_type":"Other","conditions":"Healthy","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: vitamin D","description":"50,000IU/wk of vitamin D3"},{"intervention_type":"Other","name":"Other: aerobic training","description":"7 days of treadmill training during the 13th week of study"}],"outcomes":[{"outcome_type":"primary","measure":"blood measure","time_frame":"Change from Baseline in vitamin D at 13 weeks","description":"vitamin D"},{"outcome_type":"secondary","measure":"muscle lipid","time_frame":"baseline and 13 weeks after baseline","description":"Intramyocellular lipid and extramyocellular lipid will be assessed using magnetic resonance spectroscopy and fat segmentation."},{"outcome_type":"secondary","measure":"muscle oxygen consumption","time_frame":"baseline and 13 weeks after baseline","description":"Local muscle tissue oxidative capacity will be measured using a novel hybrid diffuse optical instrument consisting of a near-infrared spectroscopy (NIRS) and a diffuse correlation spectroscopy (DCS)"}]}
{"nct_id":"NCT02469376","start_date":"2014-09-30","phase":"Phase 1","enrollment":4,"brief_title":"Evaluation of a New Imagingtechnologie for Thrombosis","official_title":"Biodistribution, Imaging Properties, and Radiation Dosimetry of [18F]-GP1 Positron Emission Tomography (PET) Tracer in Vascular Disease Imaging","primary_completion_date":"2016-12-01","study_type":"Interventional","rec_status":"Terminated","completion_date":"2016-12-01","last_update":"2017-05-09","description":"Arterial and venous thrombi play an important role in various vascular diseases such as myocardial infarction, stroke, transient ischemic attacks (TIA) and pulmonary embolism. These thromboembolic disorders are the leading causes of morbidity and mortality worldwide. A non-invasive method for the quantitative and effective detection of thrombi in the whole body has not yet been established. In spite of the available techniques, 30% to 40% of ischemic strokes \"cryptogenic\" (undetermined cause, the source of thromboembolism is never identified). Possible causes of cryptogenic stroke atherosclerosis include in the aortic arch or intracranial arteries. A plaque in the arch or other large vessels could be an important source of cryptogenic strokes, however, are those difficult to detect by routine methods. The approach of thrombus targeted molecular imaging could identify potentially troublesome plaques early on before they become a dangerous rupture. The hypothesis is that the radiotracer 18F-arterial GP1 and venous thrombi using positron emission tomography (PET) can be made visible. The primary goal is the potential applicability of the substance as a PET tracer for diagnosing thrombi.","other_id":"PET - GP1_1","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with AAA (diameter >3.5cm in duplex sonography) or acute DVT.\r\n\r\n          -  Male and female patients 18 years and older,\r\n\r\n          -  Signed Informed Consent after being informed\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  contraindications to the class of drugs under study, e.g. known hypersensitivity or\r\n             allergy to class of drugs or the investigational product,\r\n\r\n          -  women who are pregnant or breast feeding,\r\n\r\n          -  women with the intention to become pregnant during the course of the study,\r\n\r\n          -  other clinically significant concomitant disease states (e.g., renal failure, hepatic\r\n             dysfunction, cardiovascular disease),\r\n\r\n          -  renal clearance < 30 mL/min\r\n\r\n          -  known or suspected non-compliance, drug or alcohol abuse,\r\n\r\n          -  inability to follow the procedures of the study, e.g. due to language problems,\r\n             psychological disorders, dementia, etc. of the subject,\r\n\r\n          -  participation in another study with an investigational drug during the present study\r\n             and 7 days thereafter.\r\n\r\n          -  enrolment of the investigator, his family members, employees and other dependent\r\n             persons\r\n\r\n          -  last systemic treatment with GP IIb/IIIa antagonists should not have been applied\r\n             within 48 h before performing study exam\r\n      ","sponsor":"University of Zurich","sponsor_type":"Other","conditions":"Abdominal Aortic Aneurysm|Deep Vein Thrombosis","interventions":[{"intervention_type":"Drug","name":"Drug: [18F]-GP1","description":"Radiopharmaceutical Product (Tracer) to visualize with Positron Emission Tomography a thrombus in humans."}],"outcomes":[{"outcome_type":"primary","measure":"Assessment of biodistribution of [18F]-GP1 and its properties as a PET imaging agent for detection of abdominal aortic aneurysm (AAA) and deep vein thrombosis (DVT).","time_frame":"12 Months","description":"Biodistribution and diagnostic properties of the new Tracer"},{"outcome_type":"secondary","measure":"Calculation of the effective dose to the patient according to the tissue distribution data of [18F]-GP1 (Dosimetry)","time_frame":"12 Months","description":"Dosimtery assessment of the new Tracer"}]}
{"nct_id":"NCT02283320","start_date":"2014-09-30","phase":"Phase 2","enrollment":69,"brief_title":"A Study of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) as Second-line Therapy for Patients With KRAS Positive or Squamous Cell Non-Small Cell Lung Cancer","official_title":"An Open Label, Multicenter, Phase 2 Study to Determine the Safety and Efficacy of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) as a Second-Line Therapy for Patients With KRAS Mutation Positive or Squamous Cell Non-Small Cell Lung Cancer","primary_completion_date":"2016-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-04-30","last_update":"2016-04-18","description":"BIND-014 (docetaxel nanoparticles for injectable suspension) is being studied in patients with v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation positive or squamous cell non-small cell lung cancer (NSCLC) who have progressed after treatment of one prior platinum-containing chemotherapy regimen.","other_id":"BIND-014-007","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Males or females at least 18 years of age\r\n\r\n          -  Diagnosis of NSCLC with locally advanced or metastatic disease\r\n\r\n          -  Positive for KRAS mutation or Squamous cell histology\r\n\r\n          -  Previously treated with one platinum-based chemotherapy\r\n\r\n          -  Disease status must be that of measurable and/or evaluable disease\r\n\r\n          -  Performance status of 0 to 1 on the ECOG Scale\r\n\r\n          -  Prior chemotherapy completed at least 3 weeks prior to study enrollment\r\n\r\n          -  Prior radiation therapy allowed to < 25% of the bone marrow\r\n\r\n          -  Patient compliance and geographic proximity that allow adequate follow-up\r\n\r\n          -  Adequate organ function\r\n\r\n          -  Patients with reproductive potential must use contraceptive methods\r\n\r\n          -  Signed informed consent from patient\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Active infection\r\n\r\n          -  Pregnancy or planning to become pregnant\r\n\r\n          -  Breast feeding\r\n\r\n          -  Serious concomitant systemic disorders\r\n\r\n          -  Second primary malignancy\r\n\r\n          -  Patients who are symptomatic from brain metastasis\r\n\r\n          -  Presence of detectable (by physical exam) third-space fluid collections\r\n\r\n          -  More than 1 prior cytotoxic chemotherapy regimen for advanced disease\r\n\r\n          -  Prior treatment with docetaxel\r\n\r\n          -  History of severe hypersensitivity reaction to polysorbate 80\r\n\r\n          -  Peripheral neuropathy at study entry\r\n\r\n          -  Patients known to be HIV positive\r\n\r\n          -  Patients known to be seropositive for hepatitis C hepatitis B\r\n\r\n          -  Congenital long QT syndrome, congestive heart failure, or bradyarrhythmia\r\n      ","sponsor":"BIND Therapeutics","sponsor_type":"Industry","conditions":"KRAS Positive Patients With Non-small Cell Lung Cancer|Squamous Cell Non-small Cell Lung Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)"}],"outcomes":[{"outcome_type":"secondary","measure":"Disease control rate","time_frame":"Change in tumour size will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected average 18 weeks"},{"outcome_type":"secondary","measure":"Safety and tolerability, as measured by number of participants with adverse events.","time_frame":"Measured from first dose of study drug until 30 days after study discontinuation."},{"outcome_type":"secondary","measure":"Objective response rate","time_frame":"change in tumour size will be assessed using RECIST measurements. RECIST assessments will be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected 12 weeks,"},{"outcome_type":"primary","measure":"Disease control rate","time_frame":"Change in tumour size will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected average 18 weeks"},{"outcome_type":"secondary","measure":"Progression-free survival","time_frame":"Change in tumor size will be assessed using RECIST measurements. RECIST assessments will be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected average of 18 weeks."},{"outcome_type":"secondary","measure":"Overall survival","time_frame":"Participants will be followed for survival, an expected average 24 weeks after treatment discontinuation"},{"outcome_type":"secondary","measure":"Duration of response","time_frame":"Change in tumour size will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected average 18 weeks"},{"outcome_type":"secondary","measure":"Time to response","time_frame":"change in tumour size will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 relative to first dose of study drug"}]}
{"nct_id":"NCT02243852","start_date":"2014-09-30","enrollment":48,"brief_title":"Effects of Growth Hormone (GH) Deficiency and Growth Hormone Replacement on Serum Fibroblast Growth Factor 21 (FGF21)","official_title":"Evaluation of the Effects of Growth Hormone (GH) Deficiency and Growth Hormone Replacement on Serum Fibroblast Growth Factor 21 (FGF21) Concentration in Patients With Growth Hormone Deficiency (GHD)","primary_completion_date":"2015-08-31","study_type":"Observational","rec_status":"Unknown status","last_update":"2014-09-19","description":"This study will recruit healthy controls (who have normal GH production and growth hormone levels) and patients identified as having GHD, who are deemed eligible for GH replacement therapy according to NICE guidelines. The patients recruited will have been identified as starting on GH by their referring clinicians and a decision made on their replacement therapy prior to their potential enrollment in the study. The study, or its research team, will have no influence on the decision as to whether a patient will start on GH, or on which of the many GH formulations that the patients receives. The proposed study is an observational study to determine how GH affects the plasma levels of Fibroblast growth factor 21 (FGF21) in response to treatment; and whether the change in FGF21 mirrors the improvement in body composition/fat deposition. FGF21 is a metabolic regulator that acts on multiple tissues to coordinate carbohydrate and lipid metabolism and regulate energy balance. We hypothesize that FGF-21 is expressed and secreted from liver and skeletal muscle in humans in response to growth hormone administration and that levels may be reduced in patients with GHD compared with healthy controls. Furthermore, we believe that the beneficial effects of long-term GH replacement on body composition (reduction in visceral adipose tissue, subcutaneous adipose tissue and liver fat), on improvement in lipid profiles and on skeletal muscle mitochondrial function involve GH-induced release of FGF21.","other_id":"13/NW/0075","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":80,"population":"Secondary care clinic University advertisement","criteria":"\n        All evaluations to determine eligibility into the study and for growth hormone replacement\r\n        are performed as part of routine clinical care. It should be emphasised that no research\r\n        specific screening tests will be performed. Patients deemed eligible for entry into study,\r\n        who decline to participate in the research, will still be commenced on growth hormone in\r\n        line routine clinical care.\r\n\r\n        Inclusion criteria: Patients with confirmed GH deficiency who are deemed eligible for GH\r\n        replacement as assessed by the AGHDA QOL questionnaire.\r\n\r\n        Exclusion criteria: Claustrophobia or having significant metal work is a contra-indication\r\n        to MRI scanning.\r\n\r\n        Withdrawal criteria: Patients will be withdrawn from the study if they discontinue their\r\n        growth hormone replacement therapy for any clinical reason.\r\n      ","sponsor":"University of Liverpool","sponsor_type":"Other","conditions":"Growth Hormone Deficiency","interventions":[{"intervention_type":"Drug","name":"Drug: Growth Hormone Replacement Therapy","description":"An observational study of patients who are commencing GH replacement as part of their routine NHS clinical care to assess changes in serum FGF21 concentration and determine how these relate to changes in body composition."}],"outcomes":[{"outcome_type":"primary","measure":"FGF21","time_frame":"6-months","description":"The primary outcome measure involves differences in serum FGF21 concentration between healthy controls and GHD patients, and changes in FGF21 concentration with GH replacement in patients with GHD"},{"outcome_type":"secondary","measure":"Visceral and subcutaneous fat","time_frame":"6-months","description":"Differences in visceral and subcutaneous fat volume between healthy controls and GHD patients.\r\nChanges in visceral and subcutaneous fat volume after 6 months of GH."}]}
{"nct_id":"NCT02337933","start_date":"2014-09-30","phase":"Phase 2","enrollment":24,"brief_title":"Effect of Ursolic Acid Administration on Insulin Sensitivity and Metabolic Syndrome","official_title":"Effect of Ursolic Acid Administration on Insulin Sensitivity and Metabolic Syndrome","primary_completion_date":"2015-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-09-30","last_update":"2020-10-08","description":"The metabolic syndrome is characterized by the presence of overweight/obesity, insulin resistance, hyperglycemia, dyslipidaemia and hypertension and an inflammatory state, which together increase the risk of developing cardiovascular disease (CVD) or diabetes mellitus type 2 (DM2). It is also characterized by a decreased insulin sensitivity, namely, lower ability of insulin to metabolize glucose, key in the physiopathogeny of disease process. In the search for a pharmacological agent that can attend more components of the metabolic syndrome and above all improve insulin sensitivity to effectively prevent the development of CVD and DM2, ursolic acid is a promising compound. Ursolic acid is a pentacyclic carboxylic acid present in medicinal herbs, parts of some fruits like apple peel, and plants such as rosemary. There is scientific evidence of important benefits of ursolic acid level in vitro and in vivo on insulin, metabolism of lipids and glucose, as well as on the body weight and metabolic parameters. However, the results are not clear and the mechanisms are not fully elucidate. The aim of this study is to evaluate the effect of ursolic acid on the insulin sensitivity and metabolic syndrome.","other_id":"UA-MS","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":30,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Informed consent signed\r\n\r\n          -  Patients both sexes\r\n\r\n          -  Age between 30 and 60 years\r\n\r\n          -  Metabolic Syndrome according to the IDF criteria:\r\n\r\n          -  Waist circumference Man 90 cm, Woman 80 cm; and two of the following criteria:\r\n\r\n          -  High density lipoprotein Man 40 mg/dL, Woman 50 mg/dL;\r\n\r\n          -  Fasting glucose 100 mg/dL;\r\n\r\n          -  Triglycerides 150 mg/dL;\r\n\r\n          -  Blood pressure 130/85 mmHg\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Women with confirmed or suspected pregnancy\r\n\r\n          -  Women under lactation and/or puerperium\r\n\r\n          -  Hypersensibility to ursolic acid o calcined magnesia\r\n\r\n          -  Physical impossibility for taking pills\r\n\r\n          -  Known uncontrolled renal, hepatic, heart or thyroid diseased\r\n\r\n          -  Previous treatment for the metabolic syndrome components\r\n\r\n          -  Body Mass Index 39.9 kg/m2\r\n\r\n          -  Fasting glucose 126 mg/dL\r\n\r\n          -  Triglycerides 500 mg/dL\r\n\r\n          -  Total cholesterol 240 mg/dL\r\n\r\n          -  Low density lipoprotein (c-LDL) 190 mg/dL\r\n\r\n          -  Blood Pressure 140/90 mmHg\r\n      ","sponsor":"University of Guadalajara","sponsor_type":"Other","conditions":"Metabolic Syndrome X","interventions":[{"intervention_type":"Drug","name":"Drug: Ursolic acid","description":"Ursolic acid capsules of 150 mg extracted from rosemary, once a day before breakfast"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Calcined magnesia capsules of 150 mg, once a day before breakfast"}],"outcomes":[{"outcome_type":"primary","measure":"Total Insulin Sensitivity","time_frame":"Week 12","description":"The insulin sensitivity was calculated at baseline and at week 12. The value reported corresponds at week 12 with Matsuda index. Matsuda Index value is used to indicate insulin resistance on diabetes.\r\nInsulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)]. The entered values reflect the insulin sensitivity"},{"outcome_type":"primary","measure":"Waist Circumference","time_frame":"Week 12","description":"Waist circumference was evaluated at baseline and at week 12 with a flexible tape and the entered values reflect the waist circumference measure at week 12"},{"outcome_type":"primary","measure":"Fasting Glucose","time_frame":"Week 12","description":"The fasting glucose levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12"},{"outcome_type":"primary","measure":"Triglycerides","time_frame":"Week 12","description":"The triglycerides were evaluated at baseline and week 12 with enzymatic-colorimetric techniques and the entered values reflect the triglycerides level at week 12"},{"outcome_type":"primary","measure":"High Density Lipoprotein Cholesterol (HDL-c)","time_frame":"Week 12","description":"The HDL-c levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12"},{"outcome_type":"primary","measure":"Systolic Blood Pressure","time_frame":"Week 12","description":"The systolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the systolic blood pressure at week 12"},{"outcome_type":"primary","measure":"Diastolic Blood Pressure","time_frame":"Week 12","description":"The diastolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the diastolic blood pressure at week 12"},{"outcome_type":"secondary","measure":"Body Weight","time_frame":"Week 12","description":"The body weight was measured at baseline and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12"},{"outcome_type":"secondary","measure":"Body Mass Index","time_frame":"Week 12","description":"The Body Mass index was calculated at baseline and at week 12 with the Quetelet index and the entered values reflect the body mass index at week 12"},{"outcome_type":"secondary","measure":"Total Cholesterol","time_frame":"Week 12","description":"The total cholesterol was estimated by standardized techniques at baseline and week 12 and the entered values reflect the total cholesterol level at week 12"},{"outcome_type":"secondary","measure":"Low Density Lipoproteins Cholesterol (LDL-c)","time_frame":"Week 12","description":"The LDL-c levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the c-LDL levels at week 12"},{"outcome_type":"secondary","measure":"Creatinine","time_frame":"Week 12","description":"The creatinine levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the creatinine levels at week 12"},{"outcome_type":"secondary","measure":"Uric Acid","time_frame":"Week 12","description":"The uric acid levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the uric acid levels at week 12"}]}
{"nct_id":"NCT02378051","start_date":"2014-09-30","phase":"N/A","enrollment":190,"brief_title":"Staying Strong With Schools - A School-Based Resilience Support Intervention for Military-Connected Children","official_title":"Staying Strong With Schools - A School-Based Resilience Support Intervention for Military-Connected Children: A Preliminary Examination of Efficacy","primary_completion_date":"2016-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-06-30","last_update":"2017-01-10","description":"The purpose of this study is to examine whether Staying Strong With Schools, a school-based intervention to support military-connected children, will be helpful for school professionals and military parents in supporting specific needs of this population of children. As part of the partnership between three school districts in Massachusetts and the Red Sox Foundation and Massachusetts General Hospital Home Base Program, the investigators will examine the efficacy of a training delivered to these schools. The schools will be randomly divided into two groups (like a toss of a coin). Half of the schools will receive the training in 2014-2015, and the other half will be waitlisted and receive the training the following year (2015-2016). All participants (school teachers, military-connected children, and their parents) will be asked to complete questionnaires the first year. The investigators hypothesize that, compared to the control schools, at the end of the school year, SSWS schools will be associated with: (1) greater sense of competence and quality of relationships with military-connected children (MCC) among school professionals; (2) lower parental distress and increased parental sense of competence and general family functioning; and (3) increased social support, and fewer academic, emotional, and behavioral problems among MCC. The investigators hypothesize that an increase in school professionals' sense of competence in identifying and handling MCC's needs, increased quality of relationships with MCC, lower parental distress, increased parental sense of competence, and increased general family functioning will mediate the efficacy of SSWS on MCC's social support and psychosocial functioning.","other_id":"2014P000867","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":6,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  For school teachers: age 18 or older, employed as teacher in a participating school,\r\n             willingness to participate in the intervention and able to participate in the informed\r\n             consent process.\r\n\r\n          -  For military-connected children: age < 18, and currently in grade 1 through 6, student\r\n             in a participating school, at least one parent who currently serves, or had served in\r\n             the military since 9/11/01, children without a participating classroom teacher will\r\n             not receive teacher-rated assessments, but will not be excluded from the school based\r\n             intervention, parent gives permission for child to participate.\r\n\r\n          -  For military parents: male or female, age 18 or older, parent of a child enrolled in\r\n             one of the participating schools, parent or co-parent currently serves, or had served\r\n             in the military since 9/11/01, parent of a military-connected child that is eligible\r\n             to participate, willing to participate, and able to give informed consent, and\r\n             permission to release test scores, and have their child participate in SSWS, and\r\n             self-report, parental and teachers' assessments.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  For teachers: unable to attend the initial training, unable to participate in the\r\n             informed consent process.\r\n\r\n          -  For military-connected children: decline participation, determination by the principal\r\n             or teacher that participation would not be in the military-connected child's best\r\n             interest for any reason.\r\n\r\n          -  For military parents: unable to participate in the informed consent process.\r\n      ","sponsor":"Massachusetts General Hospital","sponsor_type":"Other","conditions":"Staying Strong With Schools Intervention|Waitlist Control","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Staying Strong with Schools Intervention","description":"On-Site Training to Raise Awareness about the Stress of Parental Deployment and Review Resources Helpful in Promoting military-connected children (MCC)'s Resilience. A 60-minute training will be delivered by our Liaison Trainer on-site to school professionals at the beginning of the school year.\r\nTraining and supervision of the Resilience Support Liaison (RSL). In each school receiving the Staying Strong with Schools intervention, we will train the guidance counselor to take on the role of a RSL. The RSL will develop for each MCC an individual resilience support plan that will outline the specific intervention components that will be applied for him/her."},{"intervention_type":"Other","name":"Other: Waitlist Control","description":"Receipt of an educational pamphlet outlining resources useful to support military-connected children distributed to all educators at the beginning of the school year."}],"outcomes":[{"outcome_type":"primary","measure":"The Teachers' Sense of Efficacy Scale","time_frame":"up to two years","description":"Teachers' Sense of Efficacy is the beliefs in their capability to make a difference in student learning, to be able to get through even to students who are difficult or unmotivated. The Teacher Sense of Efficacy Scale asks teachers to assess their capability concerning instructional strategies, student engagement, and classroom management. It will assess teachers' sense of competence in handling military-connected children's needs."},{"outcome_type":"primary","measure":"The Student-Teacher Relationship Scale","time_frame":"up to two years","description":"The Student-Teacher Relationship Scale (STRS) is widely used to examine teachers' relationships with young students in terms of closeness, conflict, and dependency. It will assess the quality of teachers' relationships with military-connected children."},{"outcome_type":"secondary","measure":"Parenting Sense of Competence Scale","time_frame":"up to two years","description":"The Parenting Sense of Competence scale measures parental competence on two dimensions: Satisfaction and Efficacy. It is a 16 item Likert-scale questionnaire (on a 6 point scale ranging from strongly agree [1] to strongly disagree [6]), with nine questions under Satisfaction and seven under Efficacy. Satisfaction section examines the parents' anxiety, motivation and frustration, while the Efficacy section looks at the parents' competence, capability levels, and problem-solving abilities in their parental role."},{"outcome_type":"secondary","measure":"Depression, Anxiety and Stress Scale","time_frame":"up to two years","description":"Parental distress will be assessed using the 21-item self-report Depression, Anxiety and Stress Scale. Items each reflect a negative emotional symptom. Each of these is rated on a four-point Likert scale of frequency or severity of the participants' experiences over the last week with the intention of emphasizing states over traits. These scores ranged from 0, meaning that the client believed the item \"did not apply to them at all\", to 3 meaning that the client considered the item to \"apply to them very much, or most of the time\"."},{"outcome_type":"secondary","measure":"McMaster Family Assessment Device","time_frame":"up to two years","description":"Family functioning will be assessed using the general functioning subscale of McMaster Family Assessment Device. The GF subscale consists of 12 questions to permit individuals to rate how well each statement describes their family by selecting among four responses: strongly agree, agree, disagree, strongly disagree."},{"outcome_type":"secondary","measure":"Behavior Assessment System for Children, Second Edition","time_frame":"up to two years","description":"Maladaptive and adaptive behaviors and self-perceptions will be assessed using the Behavior Assessment System for Children, Second Edition. In this study, parents will be the informants. This measure assesses child's behaviors in the school setting (Teacher Rating; TRS) as well as the home and community setting (Parent Rating; PRS) without substantial burden."},{"outcome_type":"secondary","measure":"Child and Adolescent Social Support Scale","time_frame":"up to two years","description":"Perceived social support will be assessed using the Child and Adolescent Social Support Scale. Subjects respond to items using a six-point scale, ranging from 1= \"never,\" to 6 =\"always.\""}]}
{"nct_id":"NCT02442427","start_date":"2014-09-30","phase":"Phase 3","enrollment":420,"brief_title":"\"Palivizumab Therapy for RSV-bronchiolitis\"","official_title":"Treatment of Respiratory Syncytial Virus Bronchiolitis in Young Infants With Humanized Monoclonal Antibody: A Randomized Clinical Trial (Palivizumab Study)","primary_completion_date":"2018-02-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-02-01","last_update":"2018-02-27","description":"There is a growing body of literature suggesting that monoclonal antibody could be efficacious in infants with RSV-bronchiolitis, well tolerated with no or clinically insignificant adverse effects. \"The investigators hypothesize that a single dose of iv palivizumab 15 mg/kg in diagnosed infants <3 months old with RSV bronchiolitis will result in fewer infants with readmissions to infirmary/observation or hospital for relapse during 3 weeks of follow-up after discharge\".","other_id":"14302/14","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","maximum_age":0.25,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Infants  3 months-old, presenting to the main pediatric ER with acute bronchiolitis\r\n             associated with positive RSV rapid antigen test.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients will be excluded from the study if they had 1 or more of the following\r\n             characteristics:\r\n\r\n               -  Received monoclonal antibody or IVIG within the last 3 months prior to\r\n                  randomization.\r\n\r\n               -  Receipt of steroids within 2 days before randomization.\r\n\r\n               -  Hypersensitivity to monoclonal antibodies or immunoglobulin products.\r\n\r\n               -  Immunodeficiency.\r\n\r\n               -  Suspected sepsis.\r\n\r\n               -  Seizure disorders.\r\n\r\n               -  Neuromuscular disorders.\r\n\r\n               -  Congenital heart disease.\r\n\r\n               -  Major congenital anomalies of respiratory tract.\r\n      ","sponsor":"Hamad Medical Corporation","sponsor_type":"Industry","conditions":"Respiratory Syncytial Virus-bronchiolitis","interventions":[{"intervention_type":"Drug","name":"Drug: Palivizumab","description":"A single dose of IV palivizumab 15 mg per kilogram body weight (maximum dose =100 mg). The study medication will be given by IV infusion over 30 minutes using a syringe infusion pump."},{"intervention_type":"Other","name":"Other: Placebo","description":"An equal volume of 0.9% normal saline"}],"outcomes":[{"outcome_type":"primary","measure":"Readmission to either infirmary/observation or hospital or PICU during 3 weeks of follow-up after discharge","time_frame":"3 weeks"},{"outcome_type":"secondary","measure":"Time to medical readiness for discharge","time_frame":"4 weeks"},{"outcome_type":"secondary","measure":"Revisit to any medical facility for the same illness","time_frame":"4 weeks"},{"outcome_type":"secondary","measure":"Admission to PICU during initial admission","time_frame":"4 weeks"}]}
{"nct_id":"NCT02212158","start_date":"2014-09-30","phase":"N/A","enrollment":20,"brief_title":"Diabetes Intervention Program for Adolescents With Persistent High HA1c","official_title":"Diabetes Intervention Program for Adolescents With Persistent High HA1c","primary_completion_date":"2015-04-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2015-11-30","last_update":"2014-08-08","description":"The purpose of this project is to assess the feasibility and efficacy of a new group therapy program for adolescents with Type 1 diabetes and compromised metabolic control (high A1c). This intervention is aimed at addressing issues frequently found to be associated with poor control: knowledge deficits, parental supervision, parent-teen communication and psychosocial barriers. In order to test this new group therapy program, adolescents' HA1c and psychosocial functioning will be monitored pre- and post-intervention. It is hypothesized that individuals who participate in the group therapy program will show an improvement in their HA1c levels and quality of life, self-efficacy, supportive behaviors from family members, readiness to make improvements in their diabetes care and decrease symptoms of depression.","other_id":"H2014:206","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":13,"maximum_age":17,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  The therapy group will be composed of teens that currently have a documented history\r\n             of elevated HA1c's that have persisted for at least 3 months\r\n\r\n          -  Potential candidates for the group will be recruited from all the physician's\r\n             caseloads in the clinic.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with Type II diabetes\r\n\r\n          -  Those who are medically unstable due to other medical conditions\r\n\r\n          -  Those who refuse to participate will not be included in the study\r\n      ","sponsor":"University of Manitoba","sponsor_type":"Other","conditions":"Diabetes Mellitus, Type 1","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: motivational interviewing group","description":"Group therapy sessions will include 8 teen sessions that cover the following topics: acceptance of diabetes, family issues, division of diabetes management, communication and facilitating motivation and skill development to improve diabetes care. Motivational interviewing and cognitive behavioral techniques will be the therapeutic modalities used in sessions. Parents will be involved in 3 therapy sessions that cover topics regarding family functioning, division of responsibility and parenting strategies."}],"outcomes":[{"outcome_type":"secondary","measure":"Change from baseline in Diabetes Management Questionnaire at 60 weeks","time_frame":"baseline, 60 weeks"},{"outcome_type":"secondary","measure":"Change from baseline in Child Behavior Checklist (Parent form) at 8 weeks","time_frame":"baseline, 8 weeks"},{"outcome_type":"secondary","measure":"Change from baseline in Child Behavior Checklist (Parent form) at 16 weeks","time_frame":"baseline, 16 weeks"},{"outcome_type":"primary","measure":"Change from Baseline HA1c at 6 months post baseline","time_frame":"Baseline, 6-months post baseline"},{"outcome_type":"primary","measure":"Change from baseline HA1c at 3 months post baseline","time_frame":"Baseline, 3-months post baseline"},{"outcome_type":"primary","measure":"Change from Baseline HA1c at 9 months post baseline","time_frame":"Baseline, 9-months post baseline"},{"outcome_type":"primary","measure":"Change in Baseline HA1c at 12 months post baseline","time_frame":"Baseline, 12-months post baseline"},{"outcome_type":"secondary","measure":"Change from baseline in Self-efficacy for Diabetes scale (SED) at 8 weeks","time_frame":"baseline, 8 weeks"},{"outcome_type":"secondary","measure":"Change from baseline in Self-efficacy for Diabetes scale (SED) at 16 weeks","time_frame":"baseline, 16 weeks"},{"outcome_type":"secondary","measure":"Change from baseline in Self-efficacy for Diabetes scale (SED) at 60 weeks","time_frame":"baseline, 60 weeks"},{"outcome_type":"secondary","measure":"Change from baseline in Diabetes Family Behavior Scale at 8 weeks","time_frame":"baseline, 8 weeks"},{"outcome_type":"secondary","measure":"Change from baseline in Diabetes Family Behavior Scale at 16 weeks","time_frame":"baseline, 16 weeks"},{"outcome_type":"secondary","measure":"Change from baseline in Diabetes Family Behavior Scale at 60 weeks","time_frame":"baseline, 60 weeks"},{"outcome_type":"secondary","measure":"Change from baseline in Beck Depression Inventory for Youth (BDI-Y) at 8 weeks","time_frame":"baseline, 8 weeks"},{"outcome_type":"secondary","measure":"Change from baseline in Beck Depression Inventory for Youth (BDI-Y) at 16 weeks","time_frame":"baseline, 16 weeks"},{"outcome_type":"secondary","measure":"Change from baseline in Beck Depression Inventory for Youth (BDI-Y) at 60 weeks","time_frame":"baseline, 60 weeks"},{"outcome_type":"secondary","measure":"Change from baseline in Diabetes Quality of LIfe for Youth at 8 weeks","time_frame":"baseline, 8 weeks"},{"outcome_type":"secondary","measure":"Change from baseline in Diabetes Quality of LIfe for Youth at 16 weeks","time_frame":"baseline, 16 weeks"},{"outcome_type":"secondary","measure":"Change from baseline in Diabetes Quality of LIfe for Youth at 60 weeks","time_frame":"baseline, 60 weeks"},{"outcome_type":"secondary","measure":"Change from baseline in Diabetes Management Questionnaire at 8 weeks","time_frame":"baseline, 8 weeks"},{"outcome_type":"secondary","measure":"Change from baseline in Diabetes Management Questionnaire at 16 weeks","time_frame":"baseline, 16 weeks"},{"outcome_type":"secondary","measure":"Change from baseline in Child Behavior Checklist (Parent form) at 60 weeks","time_frame":"baseline, 60 weeks"},{"outcome_type":"secondary","measure":"Change from baseline in Low Blood Sugar Survey at 8 weeks","time_frame":"baseline, 8 weeks"},{"outcome_type":"secondary","measure":"Change from baseline in Low Blood Sugar Survey at 16 weeks","time_frame":"baseline, 16 weeks"},{"outcome_type":"secondary","measure":"Change from baseline in Low Blood Sugar Survey at 60 weeks","time_frame":"baseline, 60 weeks"},{"outcome_type":"secondary","measure":"Change from baseline in Children's Hope Scale at 8 weeks","time_frame":"baseline, 8 weeks"},{"outcome_type":"secondary","measure":"Change from baseline in Children's Hope Scale at 16 weeks","time_frame":"baseline, 16 weeks"},{"outcome_type":"secondary","measure":"Change from baseline in Children's Hope Scale at 60 weeks","time_frame":"baseline, 60 weeks"}]}
{"nct_id":"NCT03591471","start_date":"2014-09-30","phase":"Phase 1/Phase 2","enrollment":500,"brief_title":"Study on Children Henoch-Schnlein Purpura Nephritis With TCM Multistep Treatment","official_title":"Demonstrated Study on Children Henoch-Schnlein Purpura Nephritis With Multistep Treatment of Traditional Chinese Medicine Combined Disease and Syndrome Differentiation","primary_completion_date":"2018-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2018-12-31","last_update":"2018-07-19","description":"The purpose of this study is to determine the optimum dosage and application method of Glycosides Of Tripterygium Wilfordii Hook(GTW) for Henoch-Schnlein Purpura Nephritis(HSPN) in children, and develop into the normal treatment protocols for Henoch-Schnlein Purpura Nephritis in children.","other_id":"TCM for Children HSPN","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":2,"maximum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Clinical diagnosis of Henoch-Schnlein Purpura Nephritis Disease\r\n\r\n          -  Age form 2-18 years old\r\n\r\n          -  Disease onset within 2 months\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Nephritis not causing by HSPN\r\n\r\n          -  Being alergic to the medicine in the treatment\r\n\r\n          -  No compliance\r\n      ","sponsor":"Henan University of Traditional Chinese Medicine","sponsor_type":"Other","conditions":"Henoch-Schnlein Purpura Nephritis","interventions":[{"intervention_type":"Drug","name":"Drug: Glycosides Of Tripterygium Wilfordii Hook(GTW)","description":"For severe HSPN GTW is 2mg/kg/d for the first 2 weeks , continued with 1.5mg/kg/d (maximum to 90mg/d) for another 2 weeks; For light HSPN GTW is 1.5mg/kg/d(maximum to 90mg/d) for 4 weeks.\r\nBoth the 2 types are continued with 1mg/kg/d of GTW for another 4 weeks . Besides,Sulfotanshinone Sodium Injection,Qingrezhixue graunles,Chinese herbs by syndrome differentiation are plused at the same time"},{"intervention_type":"Drug","name":"Drug: Sulfotanshinone Sodium Injection","description":"Intravenous drip of Sulfotanshinone Sodium Injection with the dosage of 1mg/kg/d(maximum to 50mg), combined with 100-250ml 5% Glucose Solution (G.S) for 2 weeks in both the light and serious type of TCM group."},{"intervention_type":"Drug","name":"Drug: Chinese herbs based on syndrome differentiation","description":"For both the light and serious type of HSPN in TCM group,five traditional Chinese medicine patterns of syndrome are classified on the main pathogenesis \"Blood Stasis\": based on Qingre Zhixue granule,for wind-heat complicated with blood stasis, add Forsythia, Honeysuckle,;for blood-heat complicated with blood stasis,add Buffalo horn,Comfrey; for yin deficiency complicated with blood stasis, add Rhizoma anemarrhenae,Cortex phellodendri;for both qi and yin deficiency complicated with blood stasis,add Astragalus, Heterophylla;for damp-heat complicated with blood stasis,add Scutellaria baicalensis,Lalang Grass Rhizome."},{"intervention_type":"Drug","name":"Drug: Prednisone Acetate Tablets","description":"Prednisone Acetate Tablets are necessary for serious HSPN in controlled group,the initial dosage is 2mg/kg/d(maximum to 30mg,4 weeks),continue to reduce the dosage until discontinuedReduce the dosage at the rate of 5mg every other day in 4-8 weeksthen reduce the dosage at the rate of 5-10mg per week in 8-12weeks"},{"intervention_type":"Drug","name":"Drug: Benazepril Hydrochloride Tablets","description":"In controlled group, Benazepril Hydrochloride Tablets are used for both the light and serious type with the dosage of 5-10mg/d(10mg/d for children with weight above 30kg) ,12 weeks in total."},{"intervention_type":"Drug","name":"Drug: Low Molecular Weight Heparin Calcium Injection","description":"In controlled group,Low Molecular Weight Heparin Calcium Injection are used for both the light and serious type with the dosage of 100u/kg/d by hypodermic injection for 2 weeks"},{"intervention_type":"Drug","name":"Drug: Dipyridamole Tab 25 MG","description":"In controlled group,Dipyridamole Tab 25 MG are used for both the light and serious type of HSPN with the dosage of 3mg/kg/d ,3 times a day,12 weeks in total."},{"intervention_type":"Drug","name":"Drug: Chinese medicine placebo","description":"In controlled group,take a potential necessary for patients who come to the hospital of TCM to take traditional Chinese medicine in consideration, we add the traditional Chinese medicine placebo in controlled group."}],"outcomes":[{"outcome_type":"primary","measure":"24-hour urinary protein quantity","time_frame":"Changes in the quantity of urinary protein at week 1、week2、week 4、week6、week8、week10 and week12 of the treatment phase and at week16、week20、week24、week28、week32、week36、week40、week44、week48 of the follow-up phase compared with baseline","description":"24-hour urinary protein is the most important and direct indicators of therapeutic effect,so this clinical lab index should be reccord at every point during treatment and follow-up,17 times in total."},{"outcome_type":"secondary","measure":"Urine red blood cells","time_frame":"Changes in the quantity of urinary protein at week 1、week2、week 4、week6、week8、week10 and week12 of the treatment phase and at week16、week20、week24、week28、week32、week36、week40、week44、week48 of the follow-up phase compared with baseline","description":"Compared to 24-hour urinary protein,urine red blood cells count is a secondary indicator to reflect therapeutic effect because urine red blood cells recede more slowly than protein,this clinical lab index should also be reccorded at every point during treatment and follow-up,17 times in total."},{"outcome_type":"other","measure":"The white blood cell count(WBC) in the blood","time_frame":"Week0(before treatment),week1、week2、week4、week6、week8、week10 and week12 of the treatment phase and week16、week20、week24、week28、week32、week36、week40、week44、week48 of the follow-up phase","description":"There is a potential risk of abnormality in the blood system in terms of leukocyte counts after taking immunosuppressor or prednison. Leukocyte count should be recorded in total of 17 times during and after treatment through routine blood tests."},{"outcome_type":"other","measure":"The platelet count(PLT) in the blood","time_frame":"Week0(before treatment),week1、week2、week4、week6、week8、week10 and week12 of the treatment phase and week16、week20、week24、week28、week32、week36、week40、week44、week48 of the follow-up phase","description":"There is a potential risk of abnormality in the blood system in terms of platelet counts after taking immunosuppressor or prednison. Platelet count should be recorded in total of 17 times during and after treatment through routine blood tests."},{"outcome_type":"other","measure":"Glutamate alanine transferase(ALT) in the blood","time_frame":"Week0(before treatment)，week1、week2、week4、week8、week12 of the treatment phase and week20、week28、week36、week44、week48 of the follow-up phase","description":"There is a potential risk of dysfunction in liver after using any drug. As one of the indicators of liver damage,the test of ALT should be taken in total of 11 times during and after treatment through a liver function test by taking blood from vein."},{"outcome_type":"other","measure":"Glutamate aspartate transferase(AST) in the blood","time_frame":"Week0(before treatment)，week1、week2、week4、week8、week12 of the treatment phase and week20、week28、week36、week44、week48 of the follow-up phase","description":"There is a potential risk of dysfunction in liver after using any drug. As one of the indicators of liver damage,the test of AST should be taken in total of 11 times during and after treatment through a liver function test by taking blood from vein."},{"outcome_type":"other","measure":"Serum Creatinine(Scr)","time_frame":"Week0(before treatment)，week1、week2、week4、week8、week12 of the treatment phase and week20、week28、week36、week44、week48 of the follow-up phase","description":"There is a potential risk of dysfunction in kidney after using any drug. As an indicator of kidney damage,the test of Cr should be taken in total of 11 times during and after treatment through a kidney function test by taking blood from vein."},{"outcome_type":"other","measure":"Blood Urea Nitrogen(BUN)","time_frame":"Week0(before treatment)，week1、week2、week4、week8、week12 of the treatment phase and week20、week28、week36、week44、week48 of the follow-up phase","description":"There is a potential risk of dysfunction in kidney after using any drug. As an indicator of kidney damage，the test of BUN should be taken in total of 11 times during and after treatment through a kidney function test by taking blood from vein."}]}
{"nct_id":"NCT02375451","start_date":"2014-09-30","enrollment":70,"brief_title":"Effect of Childhood Radioiodine Therapy on Salivary Function","official_title":"Effect of Childhood Radioiodine Therapy on Salivary Function","primary_completion_date":"2016-09-30","study_type":"Observational","rec_status":"Completed","completion_date":"2016-09-30","last_update":"2017-06-26","description":"Radioiodine (I-131) therapy for thyroid disease is known to decrease salivary function in adult patients. The impact of pediatric I-131 exposure on salivary function is unknown. The investigators goals are to answer this question by measuring salivary gland function before and after I-131 administration in children who receive radioiodine therapy at our hospital for thyroid disease.","other_id":"IRB-P00012399","observational_model":"Cohort","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":3,"maximum_age":55,"population":"Patients who have receive I-131 therapy in childhood for thyroid disease, compared to a\r\n        control group of patients who have never receive I-131 therapy","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients who have been treated with radioiodine therapy\r\n\r\n          -  Patients who have never received radioiodine therapy (negative control group)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Non-English speaking subjects will be excluded due to our lack of translation support\r\n             resources at this time. Of note, participation in our study cannot benefit\r\n             participants in any way.\r\n      ","sponsor":"Boston Children's Hospital","sponsor_type":"Other","conditions":"Xerostomia|Hyperthyroidism|Thyroid Cancer","interventions":[{"intervention_type":"Other","name":"Other: Radioiodine","description":"We will determine if prior radioiodine treatment in childhood impacts salivary function or symptoms. Radioiodine treatment will have been determined by the patient's medical condition and care (NOT assigned by this research study)."}],"outcomes":[{"outcome_type":"primary","measure":"Salivary function (MST value)","time_frame":"0 to 50 years after radioiodine treatment","description":"sterile paper strip is used to measure saliva production (noninvasive testing)"},{"outcome_type":"primary","measure":"Responses to Dry Mouth Questionnaire","time_frame":"At time of visit up to 4 months thereafter.","description":"Patient questionnaire/survey"},{"outcome_type":"secondary","measure":"Caries history (number of caries noted in dental records)","time_frame":"1 year before radioiodine administration to 4 months after study visit."}]}
{"nct_id":"NCT02232425","start_date":"2014-09-30","phase":"Phase 2","enrollment":88,"brief_title":"IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT) and Patient Reported Outcomes in Men With Premature Ejaculation (PE)","official_title":"An 8-Week, Double-Blind, Placebo-Controlled Parallel Group Study to Evaluate the Effect of IX-01 on Intravaginal Ejaculatory Latency Time (IELT) and Patient Reported Outcomes in Men With Lifelong Premature Ejaculation","primary_completion_date":"2015-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-10-31","last_update":"2020-08-17","description":"The purpose of this study is to determine the effectiveness of IX-01 in men with lifelong premature ejaculation.","other_id":"IX-0103","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  In stable ( 6 months) heterosexual relationship\r\n\r\n          -  Have life-long (primary) premature ejaculation\r\n\r\n          -  Have premature ejaculation confirmed by Intravaginal Ejaculatory Latency Time (IELT)\r\n             less than or equal to () 1 minute on  75% attempts at sexual intercourse\r\n\r\n          -  Meet other aspects of the International Society for Sexual Medicine (ISSM) definition\r\n             for lifelong premature ejaculation (PE), including inability to delay ejaculation on\r\n             all or nearly all vaginal penetrations and negative personal consequences such as\r\n             distress, bother and frustration\r\n\r\n          -  Willing to attempt intercourse at least 4 times during run-in period and at least 8\r\n             more times during double-blind part of the study\r\n\r\n          -  Not planning pregnancy with his partner and he is willing to use contraception (unless\r\n             not of child-bearing potential, e.g., surgically sterilised)\r\n\r\n          -  Willing to limit use of alcohol on days in which they take study drug (not more than\r\n             three drinks, where one drink is defined as a 12 ounce (oz), 360 milliliter (mL)\r\n             bottle of beer, a 5 oz (150 mL) glass of wine, or a 1 oz (45 mL distilled spirits)\r\n\r\n          -  Capable of giving written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  An Intravaginal Ejaculatory Latency Time (IELT) value  2 minutes during run-in period\r\n\r\n          -  Less than (<) 4 attempts at sexual intercourse during run-in (screening may be\r\n             extended or patient may be rescreened if there are extenuating circumstances)\r\n\r\n          -  A rating of control of ejaculation as fair, good, or very good on the Premature\r\n             Ejaculation Profile (PEP) questionnaire prior to study\r\n\r\n          -  Co-existing Erectile Dysfunction - International Index of Erectile Dysfunction (IIEF)\r\n             erectile function domain < 22 during run-in\r\n\r\n          -  Concomitant use of Phosphodiesterase 5 (PDE5) inhibitors, intracavernosal injections,\r\n             penile implants, Selective Serotonin Reuptake Inhibitors (SSRI's) or\r\n             Serotonin-Norepinephrine Reuptake Inhibitors (SSNRI's), tricyclic antidepressants (for\r\n             example (e.g.) clomipramine), monoamine oxidase inhibitors, alpha blockers, 5 alpha\r\n             reductase inhibitors (including propecia for hair loss), topical anaesthetics, and/or\r\n             tramadol\r\n\r\n          -  History (last 6 months) of use of Botox or similar product to treat premature\r\n             ejaculation\r\n\r\n          -  Unwilling to stop other treatments for premature ejaculation (including but not\r\n             limited to pharmacological, herbal, multiple condoms, psychosexual treatment, prior\r\n             masturbation)\r\n\r\n          -  Other sexual disorder of patient or partner that could interfere with results\r\n\r\n          -  Current active sexually transmitted disease\r\n\r\n          -  Major medical condition of patient that could interfere with ability to have sexual\r\n             activity and or require hospital treatment\r\n\r\n          -  Body Mass Index (BMI) > 40 kg/m2\r\n\r\n          -  Participation in a clinical drug trial anytime during the 30 days prior to screening\r\n\r\n          -  Human Immunodeficiency Virus (HIV) or hepatitis B\r\n\r\n          -  History of clinically significant prostate disease\r\n\r\n          -  History of myocardial infarction, coronary bypass surgery, coronary artery\r\n             angioplasty, unstable angina, clinically evident congestive heart failure, cardiac\r\n             pacemaker, or cerebrovascular accident\r\n\r\n          -  Cardiac arrhythmia: significant cardiac arrhythmia shown on Electrocardiogram (ECG),\r\n             or a known or suspected history of significant cardiac arrhythmias within last six\r\n             months\r\n\r\n          -  History of congenital QT prolongation and/ corrected QT (QTc) interval > 450\r\n             milliseconds (msec) using the Bazett formula\r\n\r\n          -  Mean systolic cuff blood pressure (BP) > 140 millimeter of mercury (mmHg), as assessed\r\n             by up to three measurements taken in sequence within 5-10 minutes of last measure\r\n\r\n          -  Mean diastolic cuff BP > 90 mmHg, as assessed by up to three measurements taken in\r\n             sequence within 5-10 minutes of the last measure\r\n\r\n          -  Major psychiatric disease or risk of suicidal tendency as assessed by clinical\r\n             evaluation and Patient Health Questionnaire (PHQ)-9 and Columbia Suicide Assessment\r\n\r\n          -  PHQ-9 questionnaire total score > 9 and/or score > 0 for question 9 of PHQ-9, and/or\r\n             suicidal ideation or behavior as assessed by Columbia Suicide Assessment\r\n\r\n          -  Clinically significant abnormal laboratory function test results (including liver\r\n             enzymes > 2 x Upper Limit of Normal (ULN) or bilirubin > 1.5 x ULN)\r\n\r\n          -  Taking Cytochrome P450 3A4 (CYP3A4) inducers, or moderate and potent CYP3A4 inhibitors\r\n      ","sponsor":"Ixchelsis Limited","sponsor_type":"Industry","conditions":"Premature Ejaculation","interventions":[{"intervention_type":"Drug","name":"Drug: IX-01"},{"intervention_type":"Drug","name":"Drug: Placebo"}],"outcomes":[{"outcome_type":"secondary","measure":"Mean Change in Score on Ejaculation-related Personal Distress","time_frame":"Last 4 weeks of treatment compared to baseline","description":"Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement."},{"outcome_type":"secondary","measure":"Proportion of Participants With ≥ 1 Category of Improvement in Satisfaction With Sexual Intercourse, on the Premature Ejaculation Profile (PEP) Questionnaire","time_frame":"Baseline to 8 weeks","description":"Based on Premature Ejaculation Profile (PEP) 5 point scale with the scores ranging from 0 (worse answer) to 4 (best answer)."},{"outcome_type":"primary","measure":"Mean Fold Change in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT)","time_frame":"Last 4 weeks of treatment compared to baseline","description":"IX-01 versus placebo. Intravaginal ejaculatory latency time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred"},{"outcome_type":"secondary","measure":"Proportion of Participants Rating Their PE as Better or Much Better, on the Clinical Global Impression of Change (CGIC) Scale","time_frame":"Baseline to the end of treatment (approximately 8 weeks)","description":"7 point scale ranging from much worse (-3) to much better (3). The proportion refers to the proportion of patients who had the best 2 possible responses [better(2) or much better (3)] on this 7 point scale"},{"outcome_type":"secondary","measure":"Proportion of Participants With Greater Than or Equal to (≥) 2.5 Fold Increase in Intravaginal Ejaculatory Latency Time (IELT)","time_frame":"Last 4 weeks of treatment compared to baseline","description":"Intravaginal ejaculatory latency time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred. Outcome measured proportion of patients with at least a 2.5-fold increase in geometric mean IELT over the last 4 weeks of treatment as compared to baseline. Proportion of participants adjusted for baseline IELT, country and site"},{"outcome_type":"secondary","measure":"Mean Fold Change in Arithmetic IELT (Intravaginal Ejaculatory Latency Time)","time_frame":"Last 4 weeks of treatment compared to baseline","description":"IX-01 versus placebo"},{"outcome_type":"secondary","measure":"Mean Change in Score on Control of Timing of Ejaculation","time_frame":"Last 4 weeks of treatment compared to baseline","description":"Reported in electronic diary and based on the Premature Ejaculation Profile (PEP). PEP question on control of timing is scored on a 5 point scale with the scores ranging from very poor (this is the worst answer) scored as 0 to very good (this is the best answer scored as 4)"},{"outcome_type":"secondary","measure":"Proportion of Participants With ≥ 1 Category of Improvement in Control Over Ejaculation During Sexual Intercourse on the Premature Ejaculation Profile (PEP) Questionnaire","time_frame":"Baseline to 8 weeks","description":"Reported in electronic diary and based on the Premature Ejaculation Profile (PEP). PEP is scored on a 5 point scale with the scores ranging from 0 (worst answer) to 4 (best answer)"},{"outcome_type":"secondary","measure":"Proportion of Participants With ≥ 1 Category of Improvement in Ejaculation-related Distress on the Premature Ejaculation Profile ( PEP) Questionnaire","time_frame":"Baseline to 8 weeks","description":"Reported in e-diary. Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement."},{"outcome_type":"secondary","measure":"Proportion of Participants With ≥ 1 Category of Improvement in Ejaculation-related Interpersonal Difficulty on the Premature Ejaculation Profile (PEP) Questionnaire","time_frame":"Baseline to 8 weeks","description":"Reported in e-diary. Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement."},{"outcome_type":"secondary","measure":"Proportion of Participants With ≥ 2 Category Increase in Control and ≥ 1 Category Decrease in Personal Distress on a Patient Reported Outcome (PRO) Measure","time_frame":"Baseline to 8 weeks","description":"Reported in e-diary. Based on Premature Ejaculation Profile (PEP). Each of the PEP questions is scored on a 5 point scale with the scores ranging from 0 (worst answer) to 4 (best answer)"},{"outcome_type":"secondary","measure":"Change in Percentage of Intercourse Attempts Lasting Longer Than 1 Minute From Baseline to Last 4 Weeks on Treatment","time_frame":"Baseline to last 4 weeks on treatment","description":"'Baseline' time period defined as Day -28 - Day 0. 'Last 4 Weeks' time period defined as the 28 days prior to last time subject took study drug and after Day 14.\r\nAnalysis excludes two subjects from ITT population: #010-012 (placebo) and #888-018 (active). Adjusted for treatment, baseline IELT, baseline percentage, country and site."},{"outcome_type":"secondary","measure":"Incidence of Treatment-emergent Adverse Events","time_frame":"Start of Treatment to end of study (approximately 10 weeks)","description":"Number of participants with at least one treatment-emergent adverse event"}]}
{"nct_id":"NCT01980498","start_date":"2014-09-30","phase":"Phase 3","enrollment":0,"brief_title":"PEctin Rapid Fentanyl Efficacy Clinical Trial For pAin at Swallowing Undergoing radioTherapy","official_title":"Multicenter Randomized Open Trial to Evaluate Efficacy of Fentanyl Pectin Nasal Spray vs Physician Choice-Usual Care in Reducing Predictable Breakthrough Pain at Swallowing in Head/Neck Cancer Patients Undergoing Radiotherapy","primary_completion_date":"2015-09-30","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2015-09-30","last_update":"2015-10-07","description":"The primary objective of the present phase IIIb study is to assess the efficacy of FPNS compared with Physician Choice-Usual Care (PC-UC) in the reduction of swallowing predictable BTP in head and neck cancer patients undergoing radiotherapy with or without chemotherapy.","other_id":"MOLT-2013-02","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion criteria:\r\n\r\n          1. Male and female aged 18 years or over\r\n\r\n          2. Diagnosis of stage III-IV cancer of oral cavity, oropharynx, hypopharynx, larynx,\r\n             salivary glands\r\n\r\n          3. Receiving radiation therapy (RT) with or without concurrent platinum based\r\n             chemotherapy or cetuximab as first line treatment or as postoperative adjuvant\r\n             treatment\r\n\r\n          4. Background pain controlled with at least 60 mg oral morphine daily or an equianalgesic\r\n             dose of another opioid. A \"background pain controlled\" is defined as NRS <4\r\n\r\n          5. Uncontrolled pain during swallowing (predictable BTP at swallowing) with an intensity\r\n             4 on an 11-point numeric scale (0=no pain; 10=worst possible pain). This pain will\r\n             have to be measured with the ingestion of a solid/liquid food (depending on the\r\n             ability to swallow or less solid foods of the patient at moment)\r\n\r\n          6. Patients able to receive a nasal spray therapy\r\n\r\n          7. Willing and able to sign an informed consent form\r\n\r\n          8. Females with childbearing potential must provide a negative pregnancy test and both\r\n             males and females must be using adequate contraception during the study\r\n\r\n          9. Patients with PEG or jejunostomy, if are available to take by mouth meals (solid or\r\n             liquid) or just liquid in order to be compliant with the protocol.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients with known metastatic disease\r\n\r\n          2. Known hypersensitivity to opioids, to Fentanyl or to drugs used in the PC-UC, and/or\r\n             to study medications' formulation ingredients\r\n\r\n          3. Patients with impaired chemistry laboratory exams, assessed as routine clinical\r\n             practice before radiotherapy start:\r\n\r\n             a. Hepatic function: i. Total bilirubin > 2 times the upper-normal limit (ULN) ii.\r\n             Serum transaminase > 5 times ULN b. Renal function: i. Serum creatinine concentration\r\n             > 2 times ULN\r\n\r\n          4. Pregnant or breastfeeding women\r\n\r\n          5. Patients unlikely to comply with the protocol or unable to understand the nature,\r\n             scope and possible consequences of the study\r\n\r\n          6. Patients planned to receive other investigational treatments during study period\r\n\r\n          7. Patients with moderate to severe respiratory impairment\r\n\r\n          8. Patients with nasogastric feeding tube\r\n\r\n          9. Patients that cannot take FPNS according to investigator's judgment\r\n      ","sponsor":"L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.","sponsor_type":"Industry","conditions":"Predictable BTP at Swallowing in in Head/Neck Cancer Patients Undergoing Radiotherapy Already Receiving Opioid Therapy for Background Pain","interventions":[{"intervention_type":"Drug","name":"Drug: Fentanyl pectin nasal spray (FPNS)","description":"The first dose of FPNS will be 100 mcg dose. It will be increased until 800 mcg dose."},{"intervention_type":"Drug","name":"Drug: Physician choice-Usual care (PC-UC)","description":"The PC-UC will be started at a dose according to the physician choice. If this dose of PC-UC is effective on pain control, at the following meal the patient will take the same dose of PC-UC.\r\nIf the dose of PC-UC results non effective on pain control, at the following meal the patient will take an increased dose of the same PC-UC drug or change the PC-UC drug, according to the physician choice."}],"outcomes":[{"outcome_type":"primary","measure":"Difference in the mean intensity of predictable BTP at swallowing from the baseline to 20 minutes after taking FPNS/PC-UC (PID20).","time_frame":"up to 6 (-1,+2) days"},{"outcome_type":"secondary","measure":"The difference in the mean intensity of predictable BTP at swallowing from the baseline to 10 and 30 minutes after taking FPNS/PC-UC.","time_frame":"up to 6 (-1,+2) days"},{"outcome_type":"secondary","measure":"Time to reach the maximal pain reduction after administration of FPNS/PC-UC (evaluation of reduction in pain intensity score at each time point: 10,20,30 min after administration of FPNS or PC-UC)","time_frame":"up to 6 (-1,+2) days"},{"outcome_type":"secondary","measure":"Patient's swallowing pain relief will be measured at the end of the study period through the 5-points numeric scale (0=none; 4=complete).","time_frame":"end of study"},{"outcome_type":"secondary","measure":"Clinically meaningful pain reduction will be analyzed by assessing percentages of episodes with ≥ 2 point reductions after drug treatment versus baseline and after FPNS versus PC-UC","time_frame":"up to 6 (-1,+2) days"},{"outcome_type":"secondary","measure":"Administration of rescue medication (dose and frequency)","time_frame":"up to 6 (-1,+2) days"},{"outcome_type":"secondary","measure":"Patient's dysphagia assessment. An evaluation of dysphagia by MDADI questionnaire will be performed at baseline and at the end of the study period.","time_frame":"day 1 and end of study"},{"outcome_type":"secondary","measure":"Safety and tolerability","time_frame":"up to 6 (-1,+2) days"}]}
{"nct_id":"NCT02235129","start_date":"2014-09-30","phase":"N/A","enrollment":50,"brief_title":"Six Minute Walking Test and Breath-holding","primary_completion_date":"2014-09-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2014-12-31","last_update":"2014-09-09","description":"To compare the relationship between breath-hold time and the distance in a Six Minute Walking Test in chronic obstructive pulmonary disease population.","other_id":"6MWTBH","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Screening","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":30,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  stable chronic obstructive pulmonary disease\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  contra-indication for six minutes walking test\r\n\r\n          -  difficulty to walk\r\n\r\n          -  musculoskeletal disorder\r\n      ","sponsor":"Cliniques universitaires Saint-Luc- Universit Catholique de Louvain","sponsor_type":"Other","conditions":"Chronic Obstructive Pulmonary Disease","interventions":[{"intervention_type":"Other","name":"Other: breath-holding"}],"outcomes":[{"outcome_type":"primary","measure":"six minute walking test","time_frame":"day 1"}]}
{"nct_id":"NCT02928016","start_date":"2014-09-30","phase":"N/A","enrollment":120,"brief_title":"Effectiveness of Carbohydrate Counting Method With Mixed Meals","official_title":"Effectiveness of the Carbohydrate Counting Method on Postprandial Glucose Concentrations After Consumption of Mixed Meals in Adults With Type 1 Diabetes","primary_completion_date":"2015-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-06-30","last_update":"2016-10-11","description":"In a randomized, cross-over designed study, the investigators examined the effectiveness of the carbohydrate counting method after consumption of mixed meals typical of the Greek cuisine with various protein and fat contents in a sample of people with type 1 diabetes (DM1). The investigators also tried to further explore the effects of additional extra virgin olive oil (11 ml) on the glycemic response.","other_id":"HRBD 11th Session 6/4/2014 NHA","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with type 1 diabetes\r\n\r\n          -  Intensive insulin therapy\r\n\r\n          -  HbA1c < 10%\r\n\r\n          -  >2 years with diabetes\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Food allergies\r\n\r\n          -  Diabetic neuropathy\r\n\r\n          -  Kidney disease\r\n\r\n          -  Hematological disturbances\r\n\r\n          -  Liver disease\r\n\r\n          -  Uncontrolled hypo- or hyperthyroidism\r\n\r\n          -  Arrhythmia\r\n\r\n          -  Heart disease\r\n\r\n          -  Cancer\r\n\r\n          -  Serious mental illness\r\n      ","sponsor":"Agricultural University of Athens","sponsor_type":"Other","conditions":"Type 1 Diabetes","interventions":[{"intervention_type":"Other","name":"Other: Mixed meal 1","description":"20 adults with type 1 diabetes (T1DM) on intensive insulin treatment consumed a dish made with thick pasta, minced meat and bchamel sauce and 20 g kalamata olives. The meal provided 794 kcal and contained approximately 500 kcal from protein and fat. Insulin requirements for the test meal were calculated based on the carbohydrate content of the dish according to the personalised carbohydrate to insulin ratio."},{"intervention_type":"Other","name":"Other: Mixed meal 2","description":"20 adults with type 1 diabetes (T1DM) on intensive insulin treatment consumed grilled chicken with vegetables.The meal provided 399 kcal and contained approximately 300 kcal from protein and fat. Insulin requirements for the test meal were calculated based on the carbohydrate content of the dish according to the personalised carbohydrate to insulin ratio."},{"intervention_type":"Other","name":"Other: Mixed meal 3","description":"20 adults with type 1 diabetes (T1DM) on intensive insulin treatment consumed baked giant beans and 20g kalamata olives. The meal provided 502 kcal and contained approximately 300 kcal from protein and fat. Insulin requirements for the test meal were calculated based on the carbohydrate content of the dish according to the personalised carbohydrate to insulin ratio."},{"intervention_type":"Other","name":"Other: Mixed meal 4","description":"20 adults with type 1 diabetes (T1DM) on intensive insulin treatment consumed a dish made with thick pasta, minced meat and bchamel sauce and 20 g kalamata olives and 11 ml extra virgin olive oil. The meal provided 893 kcal and contained approximately 600 kcal from protein and fat. Insulin requirements for the test meal were calculated based on the carbohydrate content of the dish according to the personalised carbohydrate to insulin ratio."},{"intervention_type":"Other","name":"Other: Mixed meal 5","description":"20 adults with type 1 diabetes (T1DM) on intensive insulin treatment consumed grilled chicken with vegetables and 11 ml extra virgin olive oil. The meal provided 497 kcal and contained approximately 300 kcal from protein and fat. Insulin requirements for the test meal were calculated based on the carbohydrate content of the dish according to the personalised carbohydrate to insulin ratio."},{"intervention_type":"Other","name":"Other: Mixed meal 6","description":"20 adults with type 1 diabetes (T1DM) on intensive insulin treatment consumed baked giant beans and 20 g kalamata olives and 11 ml extra virgin olive oil. The meal provided 601 kcal and contained approximately 400 kcal from protein and fat. Insulin requirements for the test meal were calculated based on the carbohydrate content of the dish according to the personalised carbohydrate to insulin ratio."}],"outcomes":[{"outcome_type":"primary","measure":"Capillary blood glucose","time_frame":"195 minutes","description":"Clinically useful change in capillary blood glucose, defined as the restoration of glucose within normal limits during the first two hours and until the end of the trial"}]}
{"nct_id":"NCT02242214","start_date":"2014-09-30","enrollment":106,"brief_title":"REgistry of MisOprostol 200 g Vaginal dElivery System","primary_completion_date":"2015-08-31","study_type":"Observational [Patient Registry]","rec_status":"Completed","completion_date":"2015-08-31","last_update":"2015-09-16","description":"The design of the study is post-marketing, observational, multi-centre and open-label. The study does not provide treatment; only patients to whom misoprostol 200 g vaginal delivery system (VDS) is prescribed may be included. All directions for medication usage and patient monitoring are solely at the discretion of the investigator in accordance with their usual practice and must be consistent with the Dutch prescribing information of misoprostol 200 g VDS. No other (invasive) study-related interventions or measurements are done, other than the procedures routinely performed during induction of labour. No effort is expected from the study subjects. 150 patients from 20 Dutch centres will be included.","other_id":"000188","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"Female","population":"Academic and peripheral hospitals in the Netherlands","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosis of induction of labour in women with an unfavourable cervix, from 36 weeks\r\n             gestation, in whom induction is clinically indicated\r\n\r\n          -  Decision made to prescribe misoprostol 200 g VDS according to Summary of Product\r\n             Characteristics (SmPC)\r\n\r\n          -  Willingness and ability to provide written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Misoprostol 200 g VDS is contraindicated according to the SmPC\r\n      ","sponsor":"Ferring Pharmaceuticals","sponsor_type":"Industry","conditions":"Induction of Labour","interventions":[{"intervention_type":"Drug","name":"Drug: Misoprostol"}],"outcomes":[{"outcome_type":"primary","measure":"Time to vaginal delivery of the neonate in hours","time_frame":"From insertion until vaginal delivery"}]}
{"nct_id":"NCT02218827","start_date":"2014-09-30","phase":"N/A","enrollment":30,"brief_title":"Topical Steroid Treatment For Dry Eye","official_title":"Evaluation of Steroidal Treatment For Dry Eye Disease","primary_completion_date":"2015-09-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2015-09-30","last_update":"2014-08-18","description":"Many patients refer to an oculoplastic or corneal clinic examination due to dry eye symptoms. epidemiologic studies estimate that as many as 15% of the population over 60 years suffer from dry eye. the disease can be treated both topically through several drugs or through mechanical closure of the lacrimal drainage system. in the past decade a few studies demonstrated the efficacy of anti inflammatory treatment on dry eye disease due to the inflammatory process that occurs in it. this treatment rises goblet cell counts but in the meantime elevates the intra ocular pressure and elevates the risk for infections. steroids that cause a lower increase in intraocular pressure have not been thoroughly evaluated in dry eye disease. we with to subjectively and objectively evaluate an FDA approved topical steroidal drug in the treatment of dry eye.","other_id":"dry eye01","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":21,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  referral for ophthalmic examination due to dry eye symptoms\r\n\r\n          -  ability to sign a concent form\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  former corneal, eyelid or lacrimal gland operations\r\n\r\n          -  former orbital chemotherapy or irradiation treatment\r\n      ","sponsor":"Meir Medical Center","sponsor_type":"Other","conditions":"Dry Eye","interventions":[{"intervention_type":"Drug","name":"Drug: Loteprednol Etabonate (FML)","description":"a steroid topical treatment used for moderate dry eye symptoms. this drug causes less increase in intra ocular pressure"}],"outcomes":[{"outcome_type":"primary","measure":"clinical improvement in dry eye measurements","time_frame":"two months","description":"tear break up time and schirmer 1 test will evaluate improvement in dry eye under medical treatment"},{"outcome_type":"secondary","measure":"symptomatic improvement","time_frame":"two months","description":"dry eye questionaire will be evaluated on each follow up"}]}
{"nct_id":"NCT02191137","start_date":"2014-09-23","phase":"Phase 4","enrollment":75,"brief_title":"Measuring Outcomes In Patients With Pulmonary Arterial Hypertension Not on Active Treatment (MOTION)","official_title":"A Phase IV, Prospective, Single-Arm, Open-Label Study to Measure Outcomes in Patients With Pulmonary Arterial Hypertension Not on Active Treatment","primary_completion_date":"2016-07-16","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-07-16","last_update":"2017-10-13","description":"The MOTION study was a prospective, Phase IV study for patients with Pulmonary Arterial Hypertension (PAH). The study was designed to further explore patient-reported outcomes in PAH subjects who were not on active treatment and living in the United States. In addition, the study explored the use of new telemetric technology (Accelerator band) to evaluate if this technology correlates with improvements in 6 Minute Walking Distance 6MWD in patients with PAH.","other_id":"17407","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female patients, 18 to 80 years of age at Visit 0\r\n\r\n          -  Women of childbearing potential must have a negative pre-treatment pregnancy test,\r\n             negative monthly pregnancy test, and must use reliable methods of contraception\r\n             according to the Risk Evaluation Mitigation Strategies (REMS) guidance\r\n\r\n          -  Symptomatic pulmonary arterial hypertension, World Health Organization Group 1 with a\r\n             pulmonary vascular resistance (PVR) >300 dyn*sec*cm-5, mean pulmonary artery pressure\r\n             (PAP mean) 25 mmHg, and pulmonary capillary wedge pressure (PCWP) 15 mmHg as\r\n             assessed by right heart catheterization within 6 months prior to Screening (Visit 0)\r\n\r\n          -  PAH of the following types:\r\n\r\n        Idiopathic (IPAH) Familial (FPAH)\r\n\r\n        Associated with PAH (APAH) due to:\r\n\r\n        Connective tissue disease Congenital heart disease, but only if patient underwent surgical\r\n        repair more than one year before enrollment Anorexigen or amphetamine use Portal\r\n        hypertension with liver cirrhosis\r\n\r\n          -  Not treated with PAH-specific pulmonary medications within 14 days of Screening (Visit\r\n             0)\r\n\r\n          -  6MWD between 150 meters and 450 meters\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who are pregnant\r\n\r\n          -  Patients currently on nitrate and/or nitric oxide (NO) donor therapy; patients\r\n             currently taking phosphodiesterase 5 (PDE5) inhibitors (such as sildenafil, tadalafil,\r\n             vardenafil) and non-specific PDE inhibitors (theophylline, dipyridamole)\r\n\r\n          -  Non-WHO group 1 Pulmonary Hypertension\r\n\r\n          -  Severe restrictive lung disease\r\n\r\n          -  History of uncontrolled high blood pressure or hypotension\r\n\r\n          -  A medical disorder, condition, or history that in the opinion of the Investigator\r\n             would impair their ability to participate or complete this study\r\n\r\n          -  Active state of hemoptysis or pulmonary hemorrhage, including those events managed by\r\n             bronchial artery embolization\r\n      ","sponsor":"Bayer","sponsor_type":"Industry","conditions":"Hypertension, Pulmonary","interventions":[{"intervention_type":"Drug","name":"Drug: Riociguat (Adempas, BAY63-2521)","description":"Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat."}],"outcomes":[{"outcome_type":"primary","measure":"Change From Baseline to Week 24 in the Living With Pulmonary Hypertension (LPH) Questionnaire Total Score","time_frame":"Baseline to Week 24","description":"The Living with Pulmonary Hypertension (LPH) questionnaire with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 (best) to 105 (worst) is calculated by summing the responses to all 21 questions."},{"outcome_type":"secondary","measure":"Change From Baseline to Weeks 4 and 16 in the LPH Total Score","time_frame":"Baseline to Week 4 and Week 16","description":"The Living with Pulmonary Hypertension (LPH) questionnaire with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 (best) to 105 (worst) is calculated by summing the responses to all 21 questions. In the below table, \"N\" signifies subjects who were evaluable for the specific parameter at that timepoint."},{"outcome_type":"secondary","measure":"Change From Week 16 to Week 24 in the LPH Total Score (Completers Analysis Set Only)","time_frame":"Week 16 to Week 24","description":"The Living with Pulmonary Hypertension (LPH) questionnaire with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 (best) to 105 (worst) is calculated by summing the responses to all 21 questions."},{"outcome_type":"secondary","measure":"Change From Baseline to Weeks 4, 16, and 24 in the LPH Physical Dimension Score","time_frame":"Baseline to Weeks 4, 16, and 24","description":"The LPH derived from the Minnesota Living with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition. In the below table, \"N\" signifies subjects who were evaluable for the specific parameter at that timepoint."},{"outcome_type":"secondary","measure":"Change From Week 16 to Week 24 in the LPH Physical Dimension Score (Completers Analysis Set Only)","time_frame":"Week 16 to Week 24","description":"The LPH derived from the Minnesota Living with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition."},{"outcome_type":"secondary","measure":"Change From Baseline to Weeks 4, 16, and 24 in the LPH Emotional Dimension Score","time_frame":"Baseline to Week 4, Week 16 and Week 24","description":"The LPH derived from the Minnesota Living with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition. In the below table, \"N\" signifies subjects who were evaluable for the specific parameter at that timepoint."},{"outcome_type":"secondary","measure":"Change From Week 16 to Week 24 in the LPH Emotional Dimension Score (Completers Analysis Set Only)","time_frame":"Week 16 to Week 24","description":"The LPH derived from the Minnesota Living with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition."},{"outcome_type":"secondary","measure":"Percentage of Patients With a Minimal Clinically Significant Important Difference (MCID) From Baseline in LPH Total Score at Weeks 4, 16, and 24","time_frame":"Baseline to Week 4, Week 16 and Week 24","description":"For LPH total score, the MCID was an 11-point decrease from baseline. In the below table, \"N\" signifies subjects who were evaluable for the specific parameter at that timepoint."},{"outcome_type":"secondary","measure":"Percentage of Patients With an MCID From Baseline in LPH Physical Dimension Score at Weeks 4, 16, and 24","time_frame":"Baseline to Week 4, Week 16 and Week 24","description":"For the physical and emotional dimension scores, the MCID was a 4-point decrease. In the below table, \"N\" signifies subjects who were evaluable for the specific parameter at that timepoint."},{"outcome_type":"secondary","measure":"Percentage of Patients With an MCID From Baseline in LPH Emotional Dimension Score at Weeks 4, 16, and 24","time_frame":"Baseline to Week 4, Week 16 and Week 24","description":"For the physical and emotional dimension scores, the MCID was a 4-point decrease. In the below table, \"N\" signifies subjects who were evaluable for the specific parameter at that timepoint."},{"outcome_type":"secondary","measure":"Percentage of Patients With an MCID From Week 16 in LPH Total Score at Week 24 (Completers Analysis Set Only)","time_frame":"Week 16 to Week 24","description":"For LPH total score, the MCID was an 11-point decrease."},{"outcome_type":"secondary","measure":"Percentage of Patients With an MCID From Week 16 in Physical Dimension Score at Week 24 (Completers Analysis Set Only)","time_frame":"Week 16 to Week 24","description":"For the physical and emotional dimension scores, the MCID was a 4-point decrease."},{"outcome_type":"secondary","measure":"Percentage of Patients With an MCID From Week 16 in Emotional Dimension Score at Week 24 (Completers Analysis Set Only)","time_frame":"Week 16 to Week 24","description":"For the physical and emotional dimension scores, the MCID was a 4-point decrease."},{"outcome_type":"secondary","measure":"Change From Baseline to Weeks 4, 16, and 24 in the WLQ Time Management, Physical Demands, Mental-Interpersonal Demands and Output Demands Scores","time_frame":"Baseline to Week 4, Week 16 and Week 24","description":"The Work Limitations Questionnaire (WLQ) is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Scale score range from 0 (limited none of the time) to 100 (limited all of the time) and represent the reported amount of time in the prior two weeks respondents were limited on-the-job. In the below table, \"N\" signifies subjects who were evaluable for the specific parameter at that timepoint."},{"outcome_type":"secondary","measure":"Change From Baseline to Weeks 4, 16, and 24 in the WLQ Percentage of Productivity Loss","time_frame":"Baseline to Week 4, Week 16 and Week 24","description":"The WLQ is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Using an algorithm, WLQ scale scores can be converted into an estimate of productivity loss. In the below table, \"N\" signifies subjects who were evaluable for the specific parameter at that timepoint."},{"outcome_type":"secondary","measure":"Change From Week 16 to Week 24 in the WLQ Time Management, Physical Demands, Mental-Interpersonal Demands, and Output Demands Scores (Completers Analysis Set Only)","time_frame":"Week 16 to Week 24","description":"The Work Limitations Questionnaire (WLQ) is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Scale score range from 0 (limited none of the time) to 100 (limited all of the time) and represent the reported amount of time in the prior two weeks respondents were limited on-the-job."},{"outcome_type":"secondary","measure":"Change From Week 16 to Week 24 in the WLQ Percentage of Productivity Loss (Completers Analysis Set Only)","time_frame":"Week 16 to Week 24","description":"The WLQ is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Using an algorithm, WLQ scale scores can be converted into an estimate of productivity loss."},{"outcome_type":"secondary","measure":"Change From Baseline to Weeks 4, 16, and 24 in the Short Form-12 Health Survey (SF-12) Physical Component Summary (PCS) Score and Mental Component Summary (MCS) Score","time_frame":"Baseline to Week 4, Week 16 and Week 24","description":"SF-12v2® Health Survey is a 12-item questionnaire to measure functional health and well-being from the patient's point of view. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. In the below table, \"N\" signifies subjects who were evaluable for the specific parameter at that timepoint."},{"outcome_type":"secondary","measure":"Change From Week 16 to Week 24 in the SF-12 PCS Score and MCS Score (Completers Analysis Set Only)","time_frame":"Week 16 to Week 24","description":"SF-12v2® Health Survey is a 12-item questionnaire to measure functional health and well-being from the patient's point of view. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."},{"outcome_type":"secondary","measure":"Change From Baseline to Weeks 4, 16, and 24 in the WHO Functional Class","time_frame":"Baseline to Week 4, Week 16 and Week 24","description":"Functional class was determined by the WHO classification:\r\nI: Patients with PH (pulmonary hypertension) but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.\r\nII: Patients with PH resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain, or near syncope.\r\nIII: Patients with PH resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope.\r\nIV: Patients with PH with inability to carry out any physical activity without symptoms. These patients manifest signs of right-heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity.\r\nIn the below table, \"N\" signifies subjects who were evaluable for the specific parameter at that timepoint."},{"outcome_type":"secondary","measure":"Change From Week 16 to Week 24 in the WHO Functional Class (Completers Analysis Set Only)","time_frame":"Week 16 to Week 24","description":"Functional class was determined by the WHO classification:\r\nI: Patients with PH (pulmonary hypertension) but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.\r\nII: Patients with PH resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain, or near syncope.\r\nIII: Patients with PH resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope.\r\nIV: Patients with PH with inability to carry out any physical activity without symptoms. These patients manifest signs of right-heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity."},{"outcome_type":"secondary","measure":"Change From Baseline to Weeks 16 and 24 in the Modified Borg Dyspnea Scale","time_frame":"Week 16 to Week 24","description":"The Modified Borg Dyspnea Scale assessed the intensity of the patient's dyspnea from 0 (best) to 10 (worst). In the below table, \"N\" signifies subjects who were evaluable for the specific parameter at that timepoint."},{"outcome_type":"secondary","measure":"Change From Week 16 to Week 24 in the Modified Borg Dyspnea Scale (Completers Analysis Set Only)","time_frame":"Week 16 to Week 24","description":"The Modified Borg Dyspnea Scale assessed the intensity of the patient's dyspnea from 0 (best) to 10 (worst)."},{"outcome_type":"secondary","measure":"Change From Baseline to Weeks 16 and 24 in the 6MWD","time_frame":"Week 16 to Week 24","description":"Six-minute walk distance (6MWD) was conducted to test the physical limitations of the patient by assessing the patient's exercise capacity. The distance walked by the patient in 6 minutes was measured. In the below table, \"N\" signifies subjects who were evaluable for the specific parameter at that timepoint."},{"outcome_type":"secondary","measure":"Change From Week 16 to Week 24 in the 6MWD (Completers Analysis Set Only)","time_frame":"Week 16 to Week 24","description":"Six-minute walk distance (6MWD) was conducted to test the physical limitations of the patient by assessing the patient's exercise capacity. The distance walked by the patient in 6 minutes was measured."}]}
{"nct_id":"NCT02116660","start_date":"2014-09-03","phase":"Phase 2","enrollment":11,"brief_title":"Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284)","official_title":"Switching From Regimens Consisting of a RTV-Boosted Protease Inhibitor Plus TDF/FTC to a Combination of Raltegravir Plus Nevirapine and Lamivudine in HIV Patients With Suppressed Viremia and Impaired Renal Function (RANIA Study) (Pilot Study) Protocol MK-0518-284-03","primary_completion_date":"2017-07-10","study_type":"Interventional","rec_status":"Terminated","completion_date":"2017-07-10","last_update":"2019-04-08","description":"To evaluate changes in renal function, efficacy, and safety when switching from a combination of tenofovir/emtricitabine (TDF/FTC) plus a protease inhibitor/ritonavir (PI/r) to a combination of raltegravir (MK-0518) plus nevirapine plus lamivudine in human immunodeficiency virus (HIV)-1 infected participants with suppressed viremia and impaired renal function.","other_id":"0518-284","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male, or non-pregnant, non-breastfeeding female\r\n\r\n          -  No previous history of virological failure\r\n\r\n          -  No previous exposure to non-nucleoside reverse transcriptase inhibitors or integrase\r\n             inhibitors\r\n\r\n          -  No previous history of intolerance to lamivudine\r\n\r\n          -  At least 2 documented plasma HIV-1 RNA <50 copies/mL and no HIV-1 >50 copies/mL in the\r\n             12 months before screening\r\n\r\n          -  Receiving the same protease inhibitor/ritonavir plus tenofovir/emtricitabine\r\n             combination for at least the 6 months before screening\r\n\r\n          -  Has no major International Antiviral Society (IAS)-USA mutations on genotype testing\r\n             performed before starting antiretroviral treatment\r\n\r\n          -  Sexually-active participants and their partners of child-bearing potential agree to\r\n             use a medically acceptable method of contraception from 2 weeks before Day 1 and for\r\n             at least 6 months after the last dose of study drug (postmenopausal women are not\r\n             required to use contraception; sexually-active male participants with a female partner\r\n             of child-bearing potential must provide written informed consent to information\r\n             regarding any pregnancy)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Positive for hepatitis B surface antigen (HBsAg+) or anticipated need for hepatitis C\r\n             virus treatment\r\n\r\n          -  Liver cirrhosis\r\n\r\n          -  Has a history of diabetes mellitus, defined as initiation of antidiabetic treatment or\r\n             verification of diabetes in a case report form\r\n\r\n          -  Has any cancer, excluding stable Kaposi Sarcoma\r\n\r\n          -  Allergy or sensitivity to the investigational product or excipients\r\n\r\n          -  Female participant who is nursing\r\n\r\n          -  Female participant who is pregnant or intends to become pregnant\r\n\r\n          -  Has an active Acquired Immunodeficiency Syndrome (AIDS)-defining event except stable\r\n             Kaposi Sarcoma or HIV Wasting Syndrome\r\n\r\n          -  Received any investigational drug within 30 days before screening\r\n\r\n          -  Participated in any other clinical trial within 30 days before signing informed\r\n             consent for the current trial\r\n      ","sponsor":"Merck Sharp & Dohme Corp.","sponsor_type":"Industry","conditions":"HIV Infections","interventions":[{"intervention_type":"Drug","name":"Drug: Raltegravir (MK-0518)","description":"Raltegravir (MK-0518) 400 mg tablets"},{"intervention_type":"Drug","name":"Drug: Nevirapine","description":"Nevirapine (NVP) 200 mg tablets"},{"intervention_type":"Drug","name":"Drug: Lamivudine","description":"Lamivudine (3TC) 150 mg tablets"},{"intervention_type":"Drug","name":"Drug: Tenofovir","description":"Tenofovir disoproxil fumarate (TDF) 300 mg tablets"},{"intervention_type":"Drug","name":"Drug: Emtricitabine","description":"Emtricitabine (FTC) 200 mg tablets"},{"intervention_type":"Drug","name":"Drug: Lopinavir","description":"Lopinavir (LPV) 200 mg tablets"},{"intervention_type":"Drug","name":"Drug: Ritonavir","description":"Ritonavir (r) 100 mg tablets"},{"intervention_type":"Drug","name":"Drug: Atazanavir","description":"Atazanavir (ATV) 300 mg tablets"},{"intervention_type":"Drug","name":"Drug: Darunavir","description":"Darunavir (DAR) 400 mg tablets"}],"outcomes":[{"outcome_type":"primary","measure":"Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)","time_frame":"Baseline and Week 48","description":"Glomerular Filtration Rate (eGFR) was estimated from the Modification of Diet in Renal Disease (MDRD)-6 equation. The MDRD-6 equation = 198 × [serum creatinine(mg/dL)]^-0.858 × [age]-0.167 × [0.822 if patient is female] × [1.178 if patient is black] × [serum urea nitrogen concentration (mg/dL)]^-0.293 × [urine urea nitrogen excretion (g/d)]^0.249."},{"outcome_type":"secondary","measure":"Percentage of Participants With Suppressed Viremia (<50 Copies/mL HIV-1 Ribonucleic Acid [RNA]) at Week 48","time_frame":"Week 48","description":"Plasma was to be collected at Week 48 in order to quantify HIV-1 RNA. and identify the percentage of participants with <50 copies/mL HIV-1 RNA."},{"outcome_type":"secondary","measure":"Percentage of Participants With Suppressed Viremia (<50 Copies/mL HIV-1 RNA) at Week 96","time_frame":"Week 96","description":"Plasma was to be collected at Week 96 in order to quantify HIV-1 RNA. and identify the percentage of participants with <50 copies/mL HIV-1 RNA."},{"outcome_type":"secondary","measure":"Percentage of Participants With Decline in Renal Function at Week 48","time_frame":"Week 48","description":"Decline in renal function was to be assessed by evaluating MDRD-6, creatinine clearance and serum phosphate."},{"outcome_type":"secondary","measure":"Percentage of Participants With Virologic Failure (HIV-1 RNA > 50 Copies/mL)","time_frame":"Up to Week 96","description":"Plasma was to be collected up to Week 96 in order to quantify HIV-1 RNA, and identify the percentage of participants with >50 copies/mL HIV-1 RNA."},{"outcome_type":"secondary","measure":"Change From Baseline of HIV-RNA Absolute Values","time_frame":"Baseline and Week 96","description":"Plasma was to be collected at baseline and Week 96 in order to determine the change from baseline in HIV-1 RNA."},{"outcome_type":"secondary","measure":"Percentage of Participants With Mutations Associated With Resistance to NRTIs, NNRTIs, INI, at Virological Failure.","time_frame":"Up to Week 96","description":"Participants were to be identified with mutations associated with Nucleoside/ Nucleotide Reverse Transcriptase Inhibitors (NRTIs), Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs), and Integrase Inhibitor (INI). Virological failure is defined as 2 consecutive plasma HIV-1 RNA >200 copies/mL at least two weeks apart while on previous or current ARV therapy."},{"outcome_type":"secondary","measure":"Change From Baseline in Absolute CD4+ T-lymphocyte Count","time_frame":"Baseline and Week 96","description":"Cluster of Differentiation 4 + (CD4+) T-lymphocyte cell counts were to be determined at baseline and Week 96, in order to determine the change from baseline."},{"outcome_type":"secondary","measure":"Percentage of Participants With Altered Liver Enzymes and Lipid Profile","time_frame":"Up to Week 96","description":"Values of liver enzymes and lipids were to be determined from laboratory tests, in order to identify the percentage of participants classified with altered values."},{"outcome_type":"secondary","measure":"Percentage of Participants With Altered Values of Tubular Kidney Injury Markers.","time_frame":"Up to Week 96","description":"Values of tubular kidney injury markers. were to be determined, in order to identify the percentage of participants classified with altered values."},{"outcome_type":"secondary","measure":"Percentage of Participants Having Changes From Baseline in Metabolic Bone Markers","time_frame":"Baseline and up to Week 96","description":"Changes from baseline in metabolic bone markers, serum Bone Specific Alkaline Phosphatase (s-BSAP) and C-telopeptides of type 1 Collagen (s-CTx), were to be determined, in order to classify the percentage of participants with changes."},{"outcome_type":"secondary","measure":"Area Under the Concentration Time Curve From Time 0 the Last Measurement Time t (AUC0-t) for Raltegravir and Nevirapine","time_frame":"Week 12: Fasted state (0 h) and 1, 2, 3, 6 and 12 h post-dose","description":"Blood samples were to be collected in Week 12 in order to use the trapezoidal method to determine the AUC0-t of Raltegravir and Nevirapine"},{"outcome_type":"secondary","measure":"Trough Concentration (Ctrough) for Raltegravir and Nevirapine","time_frame":"Weeks 12 and 48: at the end of dosing interval at 12 h","description":"Blood samples were to be collected in Weeks 12 and 48 in order to use the trapezoidal method to determine the Ctrough, the lowest concentration reached by the drug before the next dose is administered, of Raltegravir and Nevirapine."},{"outcome_type":"secondary","measure":"Percentage of Participants With Genotypic Resistance at Virologic Failure.","time_frame":"Up to Week 96","description":"Genotypic resistance measures the presence of particular HIV-1 mutations that give rise to drug resistance. Virological failure is defined as 2 consecutive plasma HIV-1 RNA >200 copies/mL at least two weeks apart while on previous or current ARV therapy."},{"outcome_type":"secondary","measure":"Percentage of Participants With Adherence to Study Therapy","time_frame":"Up to Week 96","description":"An Adherence Questionnaire was to be given in order to determine the percentage of participants who adhered to study therapy."},{"outcome_type":"secondary","measure":"Change From Baseline in Bone Disease Risk Assessment","time_frame":"Baseline and week 96","description":"Bone disease risk assessment was to be based on a Fracture Risk Assessment Tool (FRAX®) score in participants > 40 years old, and the change from baseline determined."},{"outcome_type":"secondary","measure":"Change From Baseline in the VACS Index","time_frame":"Baseline and week 96","description":"The Veterans Aging Cohort Risk Index (VACS Index) combines various clinical biomarkers into a cumulative index weighted according to the risk of all-cause mortality."},{"outcome_type":"secondary","measure":"Percentage of Participants Experiencing a Decline of Renal Function","time_frame":"Up to Week 96","description":"Decline in renal function was to be assessed by evaluating MDRD-6, creatinine clearance and serum phosphate."},{"outcome_type":"secondary","measure":"Change From Baseline in eGFR at Week 96","time_frame":"Baseline and Week 96","description":"Glomerular Filtration Rate (eGFR) was estimated from the Modification of Diet in Renal Disease (MDRD)-6 equation. The MDRD-6 equation = 198 × [serum creatinine(mg/dL)]^-0.858 × [age]-0.167 × [0.822 if patient is female] × [1.178 if patient is black] × [serum urea nitrogen concentration (mg/dL)]^-0.293 × [urine urea nitrogen excretion (g/d)]^0.249."}]}
{"nct_id":"NCT03353948","start_date":"2014-09-01","phase":"Phase 4","enrollment":30,"brief_title":"The Effect of a Liraglutide on IVF in Obese PCOS","official_title":"The Effect of Liraglutide on Pregnancy Rates in Obese Women With PCOS Undergoing in Vitro Fertilization: a Pilot Randomized Study","primary_completion_date":"2016-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-09-01","last_update":"2017-11-27","description":"The aim of this study was to evaluate the impact of low dose liraglutide in combination with metformin compared to metformin alone on IVF pregnancy rate (PR) and cumulatively PR (IVF and spontaneous) in infertile obese women with PCOS who had been previously poor responders regarding weight reduction with lifestyle modification and resistant to first line reproductive treatments.","other_id":"Obese PCOS IVF","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":37,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18 years old to 38 years old\r\n\r\n          -  polycystic ovary syndrome (rotterdam criteria)\r\n\r\n          -  BMI of 30 kg/m or higher\r\n\r\n          -  Infertility\r\n\r\n          -  Before IVF\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  type 1 or type 2 diabetes mellitus\r\n\r\n               -  history of carcinoma\r\n\r\n               -  Cushing's syndrome or congenital (non-classic) adrenal hyperplasia\r\n\r\n               -  personal or family history of MEN 2\r\n\r\n               -  significant cardiovascular, kidney or hepatic disease\r\n\r\n               -  the use of medications known or suspected to affect reproductive or metabolic\r\n                  functions\r\n\r\n               -  the use of statins, within 90 days prior to study entry no other ovarian\r\n                  pathology normal male semen\r\n      ","sponsor":"University Medical Centre Ljubljana","sponsor_type":"Other","conditions":"Polycystic Ovary Syndrome|Obesity|Infertility, Female","interventions":[{"intervention_type":"Drug","name":"Drug: MET","description":"In the MET group metformin was initiated at a dose of 500 mg once per day and increased by 500 mg every 3 days up to 1000 mg BID per os for 12 weeks. After 1 month IVF was done."},{"intervention_type":"Drug","name":"Drug: COMBI","description":"In the COMBI group the initial dose of MET was 500 mg for at least 2 wk and gradually increased to a final dose of 1000 mg BID. Liraglutide 1.2 mg QD s.c. was added after first two weeks of monotherapy with MET. After 1 month IVF was done."}],"outcomes":[{"outcome_type":"primary","measure":"IVF pregnancy rates","time_frame":"14 days","description":"Clinical pregnancy rate defined as the presence of a fetal heart beat by ultrasound"},{"outcome_type":"primary","measure":"BMI","time_frame":"Patient's BMI was measured at the beginning and every four weeks during 12 weeks of clinical trial. ]","description":"Patient's BMI was defined as the patient's body mass in kilograms divided by the square of their height in meters."},{"outcome_type":"primary","measure":"Cumulative pregnancy rates","time_frame":"The pregnancies were collected by phone interview after one year","description":"Number of all pregnancies (IVF pregnancies and spontaneous pregnancies) per patient"},{"outcome_type":"secondary","measure":"Oocyte nuclear maturation","time_frame":"2 days","description":"The number of metaphase 2 oocytes, metaphase 1 oocytes, and germinal vesicles"},{"outcome_type":"secondary","measure":"Embryo quality","time_frame":"6 days","description":"The embryo quality assessed by standard cleavage stage embryo grading system on day 3 of embryo culture. For any embryos grown to day 5, the embryo quality assessed by standard blastocyst grading system on day 5 of embryo culture"},{"outcome_type":"other","measure":"The other outcomes was changes changes in fasting concentrations of glucose","time_frame":"Patient's fasting blood was drawn at the beginning and every four weeks during the 12 weeks of clinical trial.","description":"Patient's blood was drawn between 8 and 9 a.m. Concentrations of fasting glucose was measured in mmol/L."},{"outcome_type":"other","measure":"The other outcomes was changes changes in fasting concentrations of insulin","time_frame":"Patient's fasting blood was drawn at the beginning and every four weeks during the 12 weeks of clinical trial.","description":"Patient's blood was drawn between 8 and 9 a.m. Fasting concentrations of insulin was measured in mU/L."},{"outcome_type":"other","measure":"Other outcome was change in blood concentration of testosterone","time_frame":"Patient's fasting blood was drawn at the beginning and every four weeks during the 12 weeks of clinical trial. ]","description":"Patient's blood was drawn between 8 and 9 a.m. Blood concentration was measured in nmol/L."},{"outcome_type":"other","measure":"Other outcome was change in blood concentration in androstenedione.","time_frame":"Patient's fasting blood was drawn at the beginning and every four weeks during the 12 weeks of clinical trial.","description":"Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of androstenedione was measured in nmol/L."},{"outcome_type":"other","measure":"Other outcome was change in blood concentrations of SHBG (sex hormone-binding globulin).","time_frame":"Patient's fasting blood was drawn at the beginning and every four weeks during the 12 weeks of clinical trial. ]","description":"Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of SHBG was measured in nmol/L."}]}
{"nct_id":"NCT02455583","start_date":"2014-08-31","phase":"N/A","enrollment":4732,"brief_title":"An Assessment of an HIV Prevention Intervention (Project AIM) Among Junior Secondary School Students in Eastern Botswana","official_title":"An Assessment of an HIV Prevention Intervention (Project AIM) on Youth Sexual Intentions, Sexual Behaviors and HSV-2 Incidence and Prevalence in Junior Secondary Schools in Eastern Botswana.","primary_completion_date":"2017-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-09-30","last_update":"2018-02-13","description":"The purpose of this study is to examine the effectiveness of an HIV prevention intervention called Project AIM (Adult Identity Mentoring) to delay onset of sexual activity and reduce sexual risk behaviors among students (approximate ages 12- 17 years) in junior secondary schools (Form 1 - 3) in Eastern Botswana.","other_id":"6451","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Currently enrolled in Form 1 at one of the 50 selected schools (longitudinal cohort)\r\n\r\n          -  Fluent and literate in English or Setswana\r\n\r\n          -  Able and willing to provide written informed assent (age 17 or under) or informed\r\n             consent (age 18 and over)\r\n\r\n          -  Parent/guardian provides permission (if age 17 or under) for child to participate\r\n\r\n        Exclusion Criteria:\r\n\r\n        - All youth who meet the inclusion criteria may fully participate in the study. No\r\n        sub-segments of the population will be excluded from participation. Individual students may\r\n        be excluded from participation by school or study staff due to circumstances in which\r\n        participation is deemed to not be in the best interest of the student, such as excessive\r\n        emotional distress.\r\n      ","sponsor":"Centers for Disease Control and Prevention","sponsor_type":"U.S. Fed","conditions":"HIV","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Project AIM (Adult Identity Mentoring)","description":"Project AIM consists of 14 sessions that are delivered twice a week. Each session is 40 minutes long."}],"outcomes":[{"outcome_type":"primary","measure":"Difference in HSV-2 incidence between the intervention and control arm","time_frame":"Baseline and 24 months"},{"outcome_type":"secondary","measure":"Self-reported sexual and sexual risk-related behavior measured by sexual initiation, number of sexual partners and frequency of alcohol use, sexual intercourse, and condom use","time_frame":"Longitudinal Cohort: baseline, 12 months, and 24 months"},{"outcome_type":"secondary","measure":"Sexual thoughts measured by frequency of thoughts about engaging in sexual activity","time_frame":"Longitudinal Cohort: baseline, 12 months, and 24 months"},{"outcome_type":"secondary","measure":"Attitudes towards education and frequency of thoughts and feelings about the future and hopelessness","time_frame":"Longitudinal Cohort: baseline, 12 months, and 24 months"},{"outcome_type":"secondary","measure":"Attitudes towards partner concurrency, transactional sex, and sexual risk communication with a partner","time_frame":"Longitudinal Cohort: baseline, 12 months, and 24 months"},{"outcome_type":"secondary","measure":"Intention to engage in sexual activity","time_frame":"Longitudinal Cohort:baseline, 12 months, and 24 months"}]}
{"nct_id":"NCT02201199","start_date":"2014-08-31","phase":"Phase 1","enrollment":36,"brief_title":"Single Dose Clamp Study To Compare Concentration/Time Profile And Metabolic Activity Profile Of 2 New Formulations Of Insulin Glargine With Lantus","official_title":"A Single-Center, Randomized, Double-Blind, 3-Treatment, 3-Period, 6-Sequence Cross-Over Study To Compare The Pharmacokinetic And Pharmacodynamic Effects of Single Doses of Insulin Glargine Given As U200 And U500 To Lantus In A Euglycemic Clamp Setting In Subjects With Type 1 Diabetes","primary_completion_date":"2014-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-11-30","last_update":"2014-12-24","description":"Primary Objective: To compare the pharmacokinetic (PK) characteristics of single doses of insulin glargine given as U200 and U500 with those of a single dose (SD) of Lantus U100 in a euglycemic clamp setting in subjects with type 1 diabetes. Secondary Objectives: To compare the metabolic activity characteristics of single doses of insulin glargine given as U200 and U500 with those of a single dose of Lantus U100 in a euglycemic clamp setting in subjects with type 1 diabetes. To assess the safety and tolerability of single doses of U200, U500 and Lantus U100 in subjects with type 1 diabetes.","other_id":"PDY13928","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Basic Science","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion criteria:\r\n\r\n          -  Male or female subjects, between 18 and 65 years of age, inclusive, with type 1\r\n             diabetes mellitus for more than one year, as defined by the American Diabetes\r\n             Association.\r\n\r\n          -  Total insulin dose <1.2 U/kg/day.\r\n\r\n          -  Minimum usual basal insulin dose 0.2 U/kg/day.\r\n\r\n          -  Body weight between 50.0 kg and 110.0 kg, Body Mass Index between 18.5 and 30.0 kg/m2\r\n             inclusive.\r\n\r\n          -  Fasting negative serum C-peptide (<0.3 nmol/L).\r\n\r\n          -  Glycohemoglobin (HbA1c) 75 mmol/mol (9.0%).\r\n\r\n          -  Stable insulin regimen for at least 2 months prior to inclusion in study.\r\n\r\n          -  Certified as otherwise healthy for Type 1 diabetes mellitus patient.\r\n\r\n          -  Women of childbearing potential with negative pregnancy test and use of a highly\r\n             effective contraceptive method or women with confirmed postmenopausal status.\r\n\r\n          -  Having given written informed consent prior to undertaking any study-related\r\n             procedure.\r\n\r\n        Exclusion criteria:\r\n\r\n          -  More than one episode of severe hypoglycemia with seizure, coma or requiring\r\n             assistance of another person during the past 6 months.\r\n\r\n          -  Frequent severe headaches and / or migraine, recurrent nausea and / or vomiting (more\r\n             than twice a month).\r\n\r\n          -  Presence or history of a drug allergy or clinically significant allergic disease\r\n             according to the Investigator's judgment.\r\n\r\n          -  Presence or history of drug or alcohol abuse (alcohol consumption >40 grams / day).\r\n\r\n          -  Smoking more than 5 cigarettes or equivalent per day, unable to refrain from smoking.\r\n\r\n          -  Any medication (including St John's Wort) within 14 days before inclusion, or within 5\r\n             times the elimination half-life or pharmacodynamic half-life of that drug, whichever\r\n             the longest and regular use of any medication in the last month before study start\r\n             with the exception of insulin products, thyroid hormones, lipid-lowering and\r\n             antihypertensive drugs, and, if female, with the exception of hormonal contraception\r\n             or menopausal hormone replacement therapy; any vaccination within the last 28 days;\r\n             any biologics (antibody or its derivatives) given within 4 months before\r\n             randomization.\r\n\r\n          -  Known hypersensitivity to insulin glargine or excipients of the study drug.\r\n\r\n          -  Any history or presence of deep leg vein thrombosis or a frequent appearance of deep\r\n             leg vein thrombosis in first degree relatives (parents, siblings or children).\r\n\r\n        The above information is not intended to contain all considerations relevant to a patient's\r\n        potential participation in a clinical trial.\r\n      ","sponsor":"Sanofi","sponsor_type":"Industry","conditions":"Type 1 Diabetes Mellitus","interventions":[{"intervention_type":"Drug","name":"Drug: insulin glargine U200 HOE901","description":"Pharmaceutical form:solution for injection Route of administration: subcutaneous"},{"intervention_type":"Drug","name":"Drug: insulin glargine U500 HOE901","description":"Pharmaceutical form:solution for injection Route of administration: subcutaneous"},{"intervention_type":"Drug","name":"Drug: insulin glargine U100 HOE901","description":"Pharmaceutical form:solution for injection Route of administration: subcutaneous"}],"outcomes":[{"outcome_type":"primary","measure":"Area under the serum insulin glargine (INS) concentration curve over the first 12 hours after dosing","time_frame":"12 hours"},{"outcome_type":"secondary","measure":"INS-Area Under the Curve (AUC) over 24 and 36 hours after dosing (INS AUC 0-24 and INS AUC 0-36)","time_frame":"36 hours"},{"outcome_type":"secondary","measure":"AUC up to the last measurable concentration","time_frame":"36 hours"},{"outcome_type":"secondary","measure":"Time to reach 50% of INS-AUC 0-36","time_frame":"36 hours"},{"outcome_type":"secondary","measure":"Time to reach INS-Cmax (INS-tmax)","time_frame":"36 hours"},{"outcome_type":"secondary","measure":"Area under the body-weight-standardized Glucose Infusion Rate (GIR) over the first 12, 24 and 36 hours after dosing (GIR-AUC0-12, GIR-AUC0-24 and, GIR-AUC0-36)","time_frame":"36 hours"},{"outcome_type":"secondary","measure":"Time to reach 50% of GIR-AUC0-36 (T50%-GIR-AUC0-36)","time_frame":"36 hours"},{"outcome_type":"secondary","measure":"Maximum smoothed body weight standardized glucose infusion rate (GIRmax) and time to GIRmax (GIR-Tmax)","time_frame":"36 hours"},{"outcome_type":"secondary","measure":"Duration of blood glucose control (time to elevation of smoothed blood glucose profile above different pre-specific blood glucose levels)","time_frame":"4 days"},{"outcome_type":"secondary","measure":"Safety and tolerability (Number of patients with adverse events, clinically significant changes in vital signs, laboratory parameters)","time_frame":"4 days"}]}
{"nct_id":"NCT02215356","start_date":"2014-08-31","phase":"Phase 2","enrollment":120,"brief_title":"Icotinib With Concurrent Radiotherapy Versus Chemotherapy With Concurrent Radiotherapy in Non-small Cell Lung Cancer","official_title":"Icotinib With Concurrent Radiotherapy Versus Etoposide/Cisplatin With Concurrent Radiotherapy in Stage III Non-small Cell Lung Cancer With EGFR 19/21 Mutation","primary_completion_date":"2018-08-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-02-28","last_update":"2014-08-13","description":"This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus chemotherapy with concurrent radiotherapy in non-small cell lung cancer","other_id":"BD-IC-IV66","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Unresectable stage IIIA / IIIB non-small cell lung cancer with EGFR 19/21 mutation\r\n\r\n          -  No previous systemic anticancer therapy\r\n\r\n          -  Measurable lesion according to RECIST with at least one measurable lesion not\r\n             previously irradiated, unless disease progression has been documented at that site\r\n\r\n          -  ECOG Performance Status of 0 to 1\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior treatment with anti-EGFR (the epidermal growth factor receptor) monoclonal\r\n             antibody or small molecular compounds therapy such as gefitinib, erlotinib or\r\n             cetuximab\r\n\r\n          -  Evidence of clinically active Interstitial Lung Diseases (patients with chronic,\r\n             stable, radiographic changes who are asymptomatic need not be excluded)\r\n\r\n          -  Known severe hypersensitivity to icotinib or any of the excipients of this product\r\n      ","sponsor":"Betta Pharmaceuticals Co., Ltd.","sponsor_type":"Industry","conditions":"Non-small Cell Lung Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Icotinib with concurrent radiotherapy","description":"Icotinib: 125 mg is administered orally three times per day."},{"intervention_type":"Drug","name":"Drug: Chemoradiotherapy","description":"Etoposide 50mg/m2, ivgtt, d1-d5; cisplatin 50mg/m2, ivgtt, d1 and d8, every 28 days for a cycle, a total of 2 cycles"}],"outcomes":[{"outcome_type":"primary","measure":"Progression-free survival","time_frame":"24 months"},{"outcome_type":"secondary","measure":"Overall survival","time_frame":"36 months"},{"outcome_type":"secondary","measure":"Objective response rate","time_frame":"8 weeks"},{"outcome_type":"secondary","measure":"Adverse events","time_frame":"54 months"}]}
{"nct_id":"NCT02125526","start_date":"2014-08-31","phase":"N/A","enrollment":100,"brief_title":"Intra-aortic Balloon Pump in Extensive Myocardial Infarction With Persistent Ischemia","official_title":"Survival Improvement in Extensive Myocardial Infarction With PERsistent Ischemia Following Intra-aortic Balloon Pump Implantation","primary_completion_date":"2018-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-12-31","last_update":"2019-05-02","description":"Patients presenting with large myocardial infarction and signs of persistent ischemia after successful percutaneous coronary intervention, have a poor prognosis with respect to outcome and development of heart failure in the future. The hypothesis of this study is that in patients in whom persistent ischemia is present, use of intra-aortic balloon pump will be beneficial and improve outcome.","other_id":"IABPinPI","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Acute ST-segment elevation myocardial infarction with summed ST-segment deviation 15\r\n             mm.\r\n\r\n          -  Insufficient ST-segment resolution (<50%) on the ECG made 10-30 minutes after the\r\n             primary PCI in the catheterization laboratory.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Initial summed ST-segment deviation less than 15 mm\r\n\r\n          -  ST-segment resolution > 50% on the ECG performed in the catheterization laboratory\r\n\r\n          -  Chest pain onset less than 2 or more than 8 hours before arrival\r\n\r\n          -  Severe aortic valve stenosis/regurgitation\r\n\r\n          -  Aortic abnormalities prohibitive for use of intra aortic balloon pump\r\n\r\n          -  Full blown cardiogenic shock with immediate requirement of left ventricular assist\r\n             device as judged necessary by the operator\r\n\r\n          -  Inability to provide informed consent\r\n\r\n          -  Pregnancy\r\n\r\n          -  Inability to perform coronary angiography by the femoral approach\r\n      ","sponsor":"Lokien van Nunen","sponsor_type":"Other","conditions":"Acute Myocardial Infarction|Persisting Ischemia|No Reflow","interventions":[{"intervention_type":"Device","name":"Device: Intra-aortic balloon pump","description":"The intra-aortic balloon pump is placed in the descending thoracic aorta and inflates and deflates in synchrony with the cardiac cycle, providing diastolic augmentation and improving coronary blood flow, while deflating before systole, providing afterload and workload reduction for the myocardium."}],"outcomes":[{"outcome_type":"primary","measure":"Composite endpoint of mortality, necessity for mechanical support due to hemodynamic deterioration, and hospital admission for heart failure","time_frame":"6 months"},{"outcome_type":"primary","measure":"All-cause mortality","time_frame":"30 days and 6 months"}]}
{"nct_id":"NCT02104336","start_date":"2014-08-31","phase":"Phase 2","enrollment":2,"brief_title":"Phase 2 Study of EPI-743 in Children With Pearson Syndrome","official_title":"An Open-Label Phase 2 Safety and Efficacy Study of EPI-743 (VincerinoneTM) in Children With Pearson Syndrome","primary_completion_date":"2015-11-30","study_type":"Interventional","rec_status":"Terminated","completion_date":"2016-02-29","last_update":"2020-11-18","description":"Treatment of Pediatric Subjects with Pearson syndrome","other_id":"EPI743-13-024","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","maximum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Genetically confirmed diagnosis of Pearson syndrome\r\n\r\n          -  Age less than 18\r\n\r\n          -  Availability of medical history for 12 months prior to enrollment\r\n\r\n          -  Abstention from use of CoQ10, vitamin E, lipoic acid and Idebenone 14 days prior to\r\n             treatment with EPI-743\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Allergy to EPI-743, sesame oil or vitamin E\r\n\r\n          -  Clinical history of bleeding/ abnormal PT/PTT\r\n\r\n          -  Concurrent inborn errors of metabolism\r\n\r\n          -  Use of anticoagulant medications\r\n\r\n          -  Participation in any interventional study within 30 days of treatment\r\n\r\n          -  Use of erythropoietin 30 days prior to trial enrollment\r\n      ","sponsor":"Edison Pharmaceuticals Inc","sponsor_type":"Industry","conditions":"Pearson Syndrome","interventions":[{"intervention_type":"Drug","name":"Drug: EPI-743","description":"EPI-743 is the quinone oxidation product of alpha-tocotrienol"}],"outcomes":[{"outcome_type":"secondary","measure":"Mortality","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Hematologic function","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Neuromuscular function","time_frame":"1 year","description":"Neuromuscular function as assessed by Gross Motor Function Measure"},{"outcome_type":"secondary","measure":"Disease severity","time_frame":"1 year","description":"Disease severity as assessed by Newcastle Pediatric Mitochondrial Disease Scale"},{"outcome_type":"secondary","measure":"Renal function","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Hepatic function","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Weight gain","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Hospitalizations","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Pancreatic function","time_frame":"1 year","description":"Pancreatic function as assessed by insulin requirement and hemoglobin A1c"},{"outcome_type":"primary","measure":"Occurence of episodes of sepsis, metabolic crisis or hepatic faillure","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Transfusion avoidance","time_frame":"1 year"},{"outcome_type":"other","measure":"Number of Dose Limiting SAEs","time_frame":"1 year","description":"Any adverse event greater than or equal to grade 3 that is deemed related to treatment with EPI-743 and not related to underlying disease"}]}
{"nct_id":"NCT02171364","start_date":"2014-08-31","phase":"N/A","enrollment":40,"brief_title":"Clinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation: Prospective Randomized Study","primary_completion_date":"2015-09-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-09-01","last_update":"2019-03-18","description":"Radiofrequency catheter ablation is highly effective in the treatment of patients with persistent atrial fibrillation. In order to decrease the recurrence rate after catheter ablation, the investigators propose to apply 'virtual' ablation on patient-specific atria by simulating 3D atrial computer model. The investigators will test with five different set of ablation methods and find successful methods for a specific patient. Then, this result will be compared to empirical catheter ablation result by randomly controlled trial.","other_id":"4-2013-0536","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":19,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosis of AF patients who performed catheter ablation of atrial fibrillation due to\r\n             uncontrolled pulse rate by anti-arrhythmic drug therapy.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  AF patients who have severe heart deformations or blood problems.\r\n\r\n          -  The patients who had been performed catheter ablation of atrial ablation.\r\n\r\n          -  The patients who missed out to recording of 3D CT, echo and electrocardiography.\r\n      ","sponsor":"Yonsei University","sponsor_type":"Other","conditions":"Atrial Fibrillation","interventions":[{"intervention_type":"Procedure","name":"Procedure: Virtual ablation in based 3D CT of patient who diagnosed AF"},{"intervention_type":"Procedure","name":"Procedure: conventional ablation based on physician's personal experience"}],"outcomes":[{"outcome_type":"primary","measure":"change of hospitalization rate","time_frame":"1, 3, 6, 12, 18 and 24 months after catheter ablation and every 6 months thereafter."},{"outcome_type":"secondary","measure":"occurence of cardiovascular disease","time_frame":"6 months"},{"outcome_type":"secondary","measure":"recurrence of AF","time_frame":"6 months"}]}
{"nct_id":"NCT01948791","start_date":"2014-08-31","phase":"Phase 4","enrollment":222,"brief_title":"16w Interventional Study on Titration and Dose/Efficacy Assessment of Exelon in Chinese Alzheimer's Disease Patients","official_title":"16 Weeks Interventional Study on Titration and Dose/Efficacy Assessment of Exelon (Rivastigmine) in Chinese Alzheimer's Disease Patients (INSTINCT)","primary_completion_date":"2015-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-09-30","last_update":"2017-02-13","description":"To investigate the efficacy of Exelon capsule at maximal tolerated dose in mild to moderate Chinese AD patients via dosage titration from 3mg/d to 12mg/d in a 16 weeks duration","other_id":"CENA713BCN05","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":50,"maximum_age":85,"population":"","criteria":"\n        Key Inclusion Criteria:\r\n\r\n          -  Have a diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria\r\n             and have a clinical diagnosis of probable AD according to NINCDS/ADRDA criteria\r\n\r\n          -  MMSE score of  10 and  26\r\n\r\n          -  The treatment nave patient and the one who have stopped the donepezil, galantamine,\r\n             huperzine A, or memantine at least 2 weeks\r\n\r\n          -  Be in stable medical condition\r\n\r\n          -  Have signed off informed consent form by patients or his/her legal guardian\r\n\r\n        Key Exclusion Criteria:\r\n\r\n          -  Severe AD\r\n\r\n          -  Patients with a history of cerebrovascular disease, Active or uncontrolled epilepsy,\r\n             Active hypothyroidism, asthma, CNS infection, other Neurodegenerative disorders, an\r\n             advanced, severe, progressive, or unstable medical condition\r\n\r\n          -  Attending other clinical trials or taking other clinical trial drugs\r\n\r\n          -  A score of > 4 on the Modified Hachinski Ischemic Scale (MHIS);\r\n\r\n          -  Patients who is using any AChEI or memantine\r\n      ","sponsor":"Novartis Pharmaceuticals","sponsor_type":"Industry","conditions":"Alzheimer's Disease","interventions":[{"intervention_type":"Drug","name":"Drug: ENA713","description":"The following strengths of Rivastigmine capsules were provided: Rivastigmine capsule strengths: 1.5mg, 3mg, 4.5mg. The 6mg dose was administered as one 1.5mg capsule and one 4.5mg capsule, and when necessary, the 3mg dose could also be administered as two 1.5mg capsules. Rivastigmine was administered from 3mg/d at baseline. Then dose escalation was made in 3mg/d increments, at a minimun of 4 weeks between dose increases to a maximum dose of 12mg/d or the individual's best tolerated dose."}],"outcomes":[{"outcome_type":"primary","measure":"Mean Change From Baseline in the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog)","time_frame":"Baseline, Week 16","description":"The Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) was used to measure change in cognitive function. Alzheimer's disease assessment scale (ADAS) is a scale to measure specific cognitive and behavior disorders in Alzheimer disease (AD) patients. The Alzheimer's disease assessment scale-cognitive subscale (ADAS-Cog) provides a total score range 0-70, and consists of 11 items with lower score indicating lighter impairment and higher total scores indicating more impairment. A negative change score indicates improvement from baseline. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated."},{"outcome_type":"secondary","measure":"Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score","time_frame":"Baseline, Week 16","description":"ADCS-ADL is a scale based on caregiver's assessment of patient's activities of daily life. It is used in clinical studies on dementia & consists of 23 items and is designed to assess patient's basic & instrumental activities of daily life, such as the abilities necessary for personal care, communicating & interacting with other people, maintaining a household, conducting hobbies & interests, & making judgments & decisions. Response to each item is obtained by interview with the caregiver. The basic activities of daily life domain includes mandatory options for best response, or \"yes\" or \"no\" questions with separate sub-questions. Higher score & more \"yes\" answers indicate better level of self-care of patient. Therefore the higher the total score is, the better the patient's functions. The total score is the sum of the scores of all the items & sub-questions,& ranges from 0 to 78. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated."},{"outcome_type":"secondary","measure":"Change From Baseline in Mini-Mental State Examination (MMSE)","time_frame":"Baseline, Week 16","description":"MMSE was used to determine patient's eligibility to participate, is an easy & practical screening test to identify cognitive disorders. Test consists of 2 parts: language (time orientation, registration & attention) & performance (recall, response to written/verbal commands, writing ability & reproduction of complex polygons); total score range: 0-30; higher score = better function. Positive change score = improvement from baseline. To meet eligibility criteria, patient's MMSE total score at screening had to be 10-26 (inclusive). Interpretation of MMSE by 4 methods: Single Cut0ff: <24=abnormal; Range: <21=Increased odds of dementia; >25=Decreased odds of dementia; Education: 21- abnormal for 8th grade education, <23=abnormal for high school education, <24=abnormal for college education; Severity: 24-30=no cognitive impairment, 18-23=mild cognitive impairment, 0-17=severe cognitive impairment. 2-sided 95% CI of difference in means between baseline & post-baseline values were calculated"},{"outcome_type":"secondary","measure":"Mean Change From Baseline in Neuropsychiatric Inventory (NPI) Score","time_frame":"Baseline, Week 16","description":"This scale assesses a larger scope of the behavior problems/disorders experienced in dementia patients, and identifies the frequency & severity of the behavior disorders, & allows rapid assessment using screening questions. 10 questions in behavior domain & 2 in autonomic nervous system domain were assessed by the investigator interviewing with the caregiver. The NPI-12 total score is the total score of the 12 items, among which the score for each domain is the product of frequency (range: 1-4 points) and severity (range: 1-3 points). The highest score for each domain is 12 points and all the domains have the same weight. Therefore the range of NPI-12 total score is 0-144 points. The NPI-10 total score is the total score of the first 10 items 0-120, which constitute the original form of this scale. A higher NPI total score indicates more severe behavior disorder. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated."},{"outcome_type":"secondary","measure":"Change From Baseline in Caregiver Burden Inventory (CBI) Score","time_frame":"Baseline, Week 16","description":"CBI, formulated by Novak and Guest in 1989, is a relatively complete and effective scale to measure caregiver burden that has been extensively adopted internationally. CBI has a total of 24 items in 5 domains, i.e., time dependency items (items 1-5), development items (items 6-10), physical health items (items 11-14), social relations items (items 15-18), and emotional heath items (items 19-24). Each item is scored on a 5-point scale based on the intensity of burden (0-4 points), so that the total score is 0-96, a higher score indicating heavier burden. It is a self-administered scale that takes about 10-15 minutes to complete. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated."}]}
{"nct_id":"NCT02198196","start_date":"2014-08-31","phase":"N/A","enrollment":75,"brief_title":"Mind/Body Stress Management to Improve Outcomes in Workplace Weight Loss Programs","official_title":"Mind/Body Stress Management to Improve Outcomes in Workplace Weight Loss Programs","primary_completion_date":"2016-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-01-31","last_update":"2016-02-05","description":"The purpose of this study is to explore the efficacy of a phone-based weight loss program that has stress management techniques integrated throughout (Weight Talk-Mindfulness). The program is targeted at employees of certain companies who meet a cut-off score on a measure of stress-related eating. The control group will receive a standard phone-based program with no additional stress management information (Weight Talk-Standard). - Hypothesis 1: Participants in Weight Talk-Mindfulness (WT-M; n=50) will experience decreases in their stress-related & emotion-related eating compared to the Weight Talk-Standard (WT-S; n=25) group. - Hypothesis 2: The WT-M group will lose more weight compared to the WT-S control group. - Hypothesis 3: Participants in WT-M will experience decreased perceived stress, increased eating self-efficacy, increased acceptance of weight-related thoughts & feelings and increased mindfulness compared to those in the WT-S control arm. - Hypothesis 4: Participants in WT-M will be equally as satisfied with their weight loss program as those in WT-S.","other_id":"1R21AT007845-01A1","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Be enrolled in the Weight Talk program, inclusion criteria:\r\n\r\n               -  Employment by one of the employers who contract for Weight Talk services\r\n\r\n               -  Being over 18 years of age\r\n\r\n               -  Speak and read English\r\n\r\n          -  Have a starting BMI between 25 and 35.\r\n\r\n          -  Score 5 or higher on the 8-item Internal Disinhibition subscale of the Eating\r\n             Inventory.\r\n\r\n          -  Have regular access to email and internet.\r\n\r\n          -  Willingness and ability to complete study and intervention procedures, including\r\n             completing assessments, engaging in moderate physical activity (e.g., walking,\r\n             swimming) and using the electronic scale at least once per week.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Type 2 Diabetes (Type 1 is an exclusion for the Weight Talk program).\r\n\r\n          -  Past diagnosis of anorexia nervosa or bulimia nervosa.\r\n\r\n          -  Weight Talk program exclusion criteria include:\r\n\r\n               -  Pregnancy\r\n\r\n               -  Bariatric surgery within past 12 months or planned in the next 6 months\r\n\r\n               -  Undergoing dialysis\r\n\r\n               -  Have Type 1 Diabetes diagnosis\r\n\r\n          -  Women who are pregnant are not eligible for the program, but contraception is not\r\n             required as this is a low risk study\r\n\r\n          -  Currently using or planning to start using a pharmaceutical weight loss drug\r\n      ","sponsor":"Consumer Wellness Solutions","sponsor_type":"Industry","conditions":"Obesity","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Weight Talk-Mindfulness"}],"outcomes":[{"outcome_type":"primary","measure":"Eating Inventory - Internal Disinhibition subscale","time_frame":"Screening and 6-month follow-up","description":"8 items, screens for emotion and stress-related eating habits"},{"outcome_type":"secondary","measure":"Body weight","time_frame":"Screening and 6-month follow-up","description":"Weight in pounds"},{"outcome_type":"other","measure":"Mindful Eating Questionnaire","time_frame":"Screening, 6-month follow-up","description":"28-item scale that measures non-judgmental awareness of physical and emotional sensations associated with eating."},{"outcome_type":"other","measure":"Rapid Fruit and Vegetable Screener","time_frame":"Screening, 6-month follow-up","description":"10-item scale that assesses fruit and vegetable intake."},{"outcome_type":"other","measure":"Fat Screener","time_frame":"Screening, 6-month follow-up","description":"17-item scale that assesses fat intake"},{"outcome_type":"other","measure":"Sweets Eating","time_frame":"Screening, 6-month follow-up","description":"2-item scale that assesses high sugar food and drink intake"},{"outcome_type":"other","measure":"Perceived Stress Scale - 4 item","time_frame":"Screening, 6-month follow-up","description":"a 4-item scale that evaluates the appraisal of stress in one's life"},{"outcome_type":"other","measure":"Binge Eating Scale","time_frame":"Screening, 6-month follow-up","description":"16-item scale that assesses the presence of binge eating behaviors."},{"outcome_type":"other","measure":"Behavioral Obesity Phenotype Scale","time_frame":"Screening, 6-month follow-up","description":"8-item scale that assesses lack of control, lack of satiation, and preoccupation with food. We include 6 out of the 8 original items; 2 of the items already exist in the Binge Eating Scale (BES). One additional Preoccupation with Food item was added."},{"outcome_type":"other","measure":"Acceptance and Action Questionnaire for Weight Related Difficulties","time_frame":"Screening, 6-month follow-up","description":"22-item scale that measures acceptance and flexibility in relation to problematic thoughts and feelings regarding weight."},{"outcome_type":"other","measure":"Generalized Anxiety Disorder scale","time_frame":"Screening, 6-month follow-up","description":"7-item diagnostic scale that assesses an individual's severity of anxiety and is used as a clinical screening tool for generalized anxiety disorder."},{"outcome_type":"other","measure":"Personal Health Questionnaire","time_frame":"Screening, 6-month follow-up","description":"2-item scale that assesses the frequency of depressed mood over the past 2 weeks and is used as a preliminary screening tool for depression."},{"outcome_type":"other","measure":"Adapted Physical Activity Measure","time_frame":"Screening, 6-month follow-up","description":"11-item scale that assesses overall activity level over the past week, adapted from measure used in the National Health and Nutrition Examination Survey (NHANES)"},{"outcome_type":"other","measure":"Five Facet Mindfulness Questionnaire: Short Form","time_frame":"Screening, 6-month follow-up","description":"24-item scale that measures non-judgmental awareness of thoughts, feelings, and physical sensations."},{"outcome_type":"other","measure":"Satisfaction and Adherence","time_frame":"6-month follow-up","description":"11-item measure consisting of Likert scale and open-ended questions about the participants' experience with the intervention and their adherence to mindfulness practice assignments."}]}
{"nct_id":"NCT02360020","start_date":"2014-08-31","phase":"Phase 4","enrollment":200,"brief_title":"The XLIMUS-DES in Very Complex Lesions","official_title":"Performance of the XLIMUS Sirolimus-eluting Coronary Stent In Very Complex Lesions","primary_completion_date":"2015-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-05-31","last_update":"2016-05-10","description":"Stent delivery failure occurs in 4% of all percutaneous coronary interventions (PCI) and >90% of these failures are due to vessel tortuosity and/or calcification. The XLIMUS eluting coronary stent (CARDIONOVUM GmbH, Bonn, Germany) is a new type of endovascular prostheses characterised by better mechanical properties than traditional DES. This is a prospective, non-randomized, single-center pilot study, aiming to evaluate the performance of the XLIMUS DES in severely complex coronary lesions in real-world clinical practice.","other_id":"NCTCM03","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":90,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  chronic total occlusion (CTO)\r\n\r\n          -  severe calcification\r\n\r\n          -  severe tortuosity\r\n\r\n        Exclusion Criteria:\r\n\r\n         coronary artery lesions non satisfying the inclusion criteria\r\n      ","sponsor":"Clinica Mediterranea","sponsor_type":"Other","conditions":"Coronary Atherosclerosis Due to Calcified Coronary Lesion|Chronic Total Occlusion of Coronary Artery","interventions":[{"intervention_type":"Device","name":"Device: XLimus","description":"Techniques attempted for facilitating stent delivery in such a complex lesions are: maximize guide catheter support, optimize predilatation of the stenosis, use of a stiffer guidewire. Specific tricks include: a) buddy-wire; anchoring balloon; GuideLiner catheter. In case of severe calcification, rotational atherectomy was electively performed with the Rotablator system (Boston Scientific Corporation, Natick, MA, U.S.A.). Following stent implantation, postdilatation is performed in all instances with a non-compliant balloon"}],"outcomes":[{"outcome_type":"primary","measure":"Stent Performance","time_frame":"up to 1 month","description":"The primary objective of the study was the assessment of the clinical performance of the XLIMUS DES, using the following criteria 1) device success, defined as the ability to insert the stent into the target lesion and the attainment of <20% residual stenosis (by visual estimate), 2) lesion success, defined as attainment of <20% residual stenosis of the target lesion using any percutaneous method, and 3) procedural success, defined as lesion success without any in-hospital Man 30-day MACE"},{"outcome_type":"secondary","measure":"Inhospital, 30-day and 1-year MACE","time_frame":"1 year","description":"Major adverse cardiac events included death of any cause, nonfatal myocardial infarction, and repeated revascularization by PCI or surgery occurring within 30-day and 1-year. Myocardial infarction was defined as the presence of pathological and new Q waves on an ECG or as an increase in creatine kinase-myocardial band level to >3 times the upper limit of normal (ULN). Periprocedural myocardial infarction was defined as an increase of troponin I ≥5 times ULN. Target lesion revascularization was defined as a clinically-driven repeat percutaneous coronary angioplasty or coronary artery bypass surgery. Stent thrombosis was defined according to the Academic Research Consortium definitions"}]}
{"nct_id":"NCT03332446","start_date":"2014-08-31","phase":"N/A","enrollment":11,"brief_title":"Influence of Cooling on the Effect of Strength Training","official_title":"Influence of Cooling on the Effect of Strength Training","primary_completion_date":"2017-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-07-31","last_update":"2017-11-17","description":"The aim of this study is to investigate if regular cold water immersion after strength training has a negative influence on the desired training-induced performance enhancement.","other_id":"2512BI1901","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  healthy, 18-40 years, strength training experience, 8 weeks no leg strength training\r\n\r\n        Exclusion Criteria:\r\n\r\n        -\r\n      ","sponsor":"Universitt des Saarlandes","sponsor_type":"Other","conditions":"Strength Training Effects","interventions":[{"intervention_type":"Other","name":"Other: cold water immersion","description":"10 min at 12-15C"}],"outcomes":[{"outcome_type":"primary","measure":"1 Repetition Maximum","time_frame":"8 weeks","description":"Maximum weight in kg that can be successfully moved in a leg press"},{"outcome_type":"secondary","measure":"Counter Movement Jump","time_frame":"8 weeks","description":"Maximum jump height in cm in a counter movement jump, measured with a force plate"},{"outcome_type":"secondary","measure":"blood parameters","time_frame":"8 weeks","description":"CRP, CK, IL-6, IGF-1"},{"outcome_type":"secondary","measure":"muscle biopsy","time_frame":"8 weeks","description":"p70S6, PAX7+, NCAM+"},{"outcome_type":"secondary","measure":"muscle thickness","time_frame":"8 weeks","description":"upper leg circumference in cm"},{"outcome_type":"secondary","measure":"subjective restfulness of sleep","time_frame":"2 weeks","description":"5-point Likert scale on subjective restfulness of sleep (1: very, 5: not at all)"},{"outcome_type":"secondary","measure":"time in bed","time_frame":"2 weeks","description":"Questionnaire recording time of going to bed (time in hh:mm), sleep onset latency (duration in min), waking time (time in hh:mm), and time of getting up (time in hh:mm). From these items, the average time in bed per day is calculated, starting at \"time of going to bed\" and ending at \"time of getting up\"."},{"outcome_type":"secondary","measure":"sleeping time","time_frame":"2 weeks","description":"Questionnaire recording time of going to bed (time in hh:mm), sleep onset latency (duration in min), waking time (time in hh:mm), and time of getting up (time in hh:mm). From these items, the average sleeping time per day is calculated, starting at \"time of going to bed + sleep onset latency\" and ending at \"waking time\"."},{"outcome_type":"secondary","measure":"questionnaire on recovery and stress","time_frame":"2 weeks","description":"Short Recovery and Stress Scale for Sport (SRSS): assessing recovery (physical performance capability, mental performance capability, emotional balance, overall recovery) and stress (muscular stress, lack of activation, negative emotional state, overall stress), each item is rated on a 7-point rating scale (0: does not apply at all, 6: fully applies). For evaluation, two outcome values (\"recovery\" and \"stress\") are calculated as the sum of the corresponding subvalues, i.e. each outcome value is on a 25-point scale (0: does not apply at all, 24: fully applies)."}]}
{"nct_id":"NCT02307305","start_date":"2014-08-31","phase":"Phase 2","enrollment":168,"brief_title":"Does Duloxetine Reduce Chronic Pain After Total Knee Arthroplasty?","official_title":"Does Duloxetine Reduce Chronic Pain After Total Knee Arthroplasty?","primary_completion_date":"2016-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2016-12-31","last_update":"2016-02-19","description":"Range from 24% to 44%, with a prevalence of neuropathic-type pain from 6% to 20%-cause impairment in quality of life and functional capacity after total knee arthroplasty(TKA). Duloxetine (cymbalta) is a selective serotonin and nor-epinephrine reuptake inhibitor shown to be effective in treating chronic pain. Serotonin and norepinephrine in the brain and spinal cord are believed to both mediate core mood symptoms and help regulate the perception of pain. Its effects on depression and anxiety symptoms, as well as its effect on pain perception, may be due to increasing the activity of serotonin and norepinephrine in the central nervous system. Approved for the acute and maintenance treatment of major depressive disorder, the acute treatment of generalized anxiety disorder, the management of diabetic peripheral neuropathic pain and the management of fibromyalgia, all in adults (18+). Investigators will compare the neuropathic pain following TKA in duloxetine group (n=84) with those in non-duloxetine group (n=84). Investigators will classify the participants in to 2 groups (duloxetine and non-duloxetine group) randomly, and primarily evaluate the degree of neuropathic pain using the S-LANSS pain scale (preoperatively and postoperatively 3 and 6 months). All participants will receive postoperative pain control after TKA using the same pain control regimen except duloxetine.","other_id":"cymbaltaTKR","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":50,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Osteoarthritis of knee requiring TKA\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Rheumatoid arthritis\r\n\r\n          -  Other inflammatory arthritis\r\n\r\n          -  Neuropsychiatric patients\r\n\r\n          -  Hepatic insufficiency\r\n\r\n          -  Renal insufficiency\r\n\r\n          -  Patients older than 75\r\n\r\n          -  Allergy or intolerance to study medications\r\n\r\n          -  Patients with an ASA of IV (angina, congestive heart failure, dementia,\r\n             cerebrovascular accident)\r\n\r\n          -  Chronic gabapentin or pregabalin use (regular use for longer than 3 months)\r\n\r\n          -  Chronic opioid use (taking opioids for longer than 3 months)\r\n      ","sponsor":"Hanyang University Seoul Hospital","sponsor_type":"Other","conditions":"Neuropathic Pain","interventions":[{"intervention_type":"Drug","name":"Drug: Duloxetine","description":"Phase I (preemptive): 2 hour before surgery (30mg for 1 day)\r\nPhase II (titration): POD#1~6 (30mg for another 6 days)\r\nPhase III (maintenance): POD#7~13(60mg for 7 days)\r\nPhase IV (tapering-1): POD#14~20 (30mg for 7 days)\r\nPhase V (tapering-2): POD#21~27 (30mg another every day for 7 days)"},{"intervention_type":"Drug","name":"Drug: celecoxib, naproxen/esomeprazole, acetaminophen/tramadol, oxycodone/naloxone","description":"Preemptive analgesia : celebrex, Patient controlled analgesia (postop. 28 hours), During admission : celebrex BP or vimovo BP +ultracet ER BP, targin HS, Discharge medication: celebrex BP or vimovo BP, ultracet ER BP(PRN)"}],"outcomes":[{"outcome_type":"primary","measure":"neuropathic pain(the self assessed-Leeds Assessment of Neuropathic Symptoms and Signs pain scale, S-LANSS)","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Numeric rating scale for pain (NRS)","time_frame":"6 months"},{"outcome_type":"secondary","measure":"American Knee Society knee and function score","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Western Ontario and McMaster University Arthritis Index (WOMAC)","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Geriatric depression scale-short form","time_frame":"6 months"}]}
{"nct_id":"NCT02424864","start_date":"2014-08-31","phase":"N/A","enrollment":54,"brief_title":"4D FDG PET in Esophageal Cancer","official_title":"4D PET-CT Imaging in Esophageal Cancer","primary_completion_date":"2017-05-19","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-05-19","last_update":"2017-09-28","description":"FDG PET-CT image acquisition in the abdominal and thoracic region is influenced by organ motion. Respiratory movement blurs the metabolic signal of the esophageal tumor and lymph nodes. The investigators hypothesize that the metabolic signal obtained with motion compensation results in higher SUV-max values and clearer demarcation of the esophageal tumor and lymph nodes.","other_id":"N14FDG","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with pathology proven esophageal cancer or tumor highly suspicious for\r\n             esophageal cancer\r\n\r\n          -  > 18 years\r\n\r\n          -  Written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  <18 years\r\n\r\n          -  Possibility of pregnancy\r\n      ","sponsor":"The Netherlands Cancer Institute","sponsor_type":"Other","conditions":"Esophageal Cancer","interventions":[{"intervention_type":"Other","name":"Other: 4d PET-CT","description":"Patients will be imaged with 4D-CT images in addition to the normal protocol of FDG-CT image acquisition"}],"outcomes":[{"outcome_type":"primary","measure":"The estimation of tumor size of the primary esophageal tumor on 4Dvs 3D FDG PET","time_frame":"one year"},{"outcome_type":"secondary","measure":"Measurement of SUV max, SUV mean, and SUV peak in 4D versus 3D images of esophageal cancer and lymph nodes and number of suspected involved lymph nodes","time_frame":"one year","description":"measurement of the SUV is a composite measurement in each FDG PET scan"}]}
{"nct_id":"NCT02195245","start_date":"2014-08-31","phase":"N/A","enrollment":20,"brief_title":"A New and Innovative Method for CO2 Removal in Anesthetic Circuits: Replacing Chemical Granulate","official_title":"A New and Innovative Method for CO2 Removal in Anesthetic Circuits: Replacing Chemical Granulate","primary_completion_date":"2014-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-10-31","last_update":"2016-10-13","description":"CO2 removal is a mandatory part of modern anesthesia systems. Current chemical absorbers pose problems as the chemical granulate reacts not only with the CO2 but also the anesthetic drugs, producing organ toxic substances. The proposed CO2 absorber provides a solution to the problem of organ-toxin production in anesthetic circuits.","other_id":"DMF-CLIN-14-01","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  American Society of Anesthesiology Physical Status Class I, II, III (low-medium risk\r\n             patient)\r\n\r\n          -  English-speaking patients\r\n\r\n          -  Scheduled for elective surgery\r\n\r\n          -  Length of anesthesia  60 minutes\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnant\r\n\r\n          -  American Society of Anesthesiology Physical Status Class IV (high risk patient)\r\n\r\n          -  Patients schedule for emergency surgery\r\n\r\n          -  Known respiratory disease, including COPD and severe asthma\r\n\r\n          -  Have elevated pressure in your brain (intra cranial pressure, ICP)\r\n      ","sponsor":"DMF Medical Incorporated","sponsor_type":"Industry","conditions":"End Tidal CO2|CO2 Removal","interventions":[{"intervention_type":"Device","name":"Device: memsorb"}],"outcomes":[{"outcome_type":"primary","measure":"End tidal CO2 level","time_frame":"Continuous (5min intervals) over duration of anesthesia. No data collection prior or post anesthesia.","description":"After completion of the surgery, the digital respiration records are exported from the hospital database.\r\nEnd tidal CO2 is assessed as either in range [4.1-5.6]% or out of range <4.1% or >5.6%."}]}
{"nct_id":"NCT03318367","start_date":"2014-08-06","phase":"N/A","enrollment":23,"brief_title":"Virtual Reality Education Module in Reducing Anxiety and Increasing Knowledge in Patients With Prostate Cancer Undergoing Radiation Therapy","official_title":"A Pilot Study to Determine if the Use of a Virtual Reality Education Module Reduces Anxiety and Increases Comprehension in Patients Receiving Radiation Therapy","primary_completion_date":"2016-06-03","study_type":"Interventional","rec_status":"Terminated","completion_date":"2016-08-11","last_update":"2017-10-27","description":"This pilot clinical trial studies a virtual reality education module in reducing anxiety and increasing knowledge in patients with prostate cancer undergoing radiation therapy. A virtual reality education module may be useful in helping patients understand what they can expect to happen during their radiation treatments and help reduce stress relating to the radiation treatments.","other_id":"14D.354","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  English speaking males capable of giving informed consent\r\n\r\n          -  Must be able to read English language\r\n\r\n          -  Receiving pre-treatment cone beam and volumetric modulated arc therapy (VMAT) for\r\n             prostate cancer on the \"A\" or \"B\" treatment machines at the Bodine Center\r\n\r\n          -  Must be able to walk two city blocks\r\n\r\n          -  Must not have any auditory or visual deficits\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  If inclusion criteria are not met\r\n\r\n          -  Previous radiation therapy treatment\r\n\r\n          -  Employment in radiation oncology\r\n      ","sponsor":"Sidney Kimmel Cancer Center at Thomas Jefferson University","sponsor_type":"Other","conditions":"Prostate","interventions":[{"intervention_type":"Other","name":"Other: Educational Intervention","description":"Complete virtual reality education module"}],"outcomes":[{"outcome_type":"primary","measure":"Standard deviation for difference in questionnaire response from pre-education to post-education","time_frame":"Through study completion, an average of 2 years","description":"A one-sided one-sample t-test will be used to analyze the average change score (pre - post) for each questionnaire."}]}
{"nct_id":"NCT01468012","start_date":"2014-07-31","phase":"Phase 2/Phase 3","enrollment":23,"brief_title":"Imaging the Neurobiology of Behavioral and Medication Treatment for Cocaine Dependence","official_title":"Imaging the Neurobiology of Behavioral and Medication Treatment for Cocaine Dependence","primary_completion_date":"2014-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-12-31","last_update":"2018-05-22","description":"The proposed study will look at cocaine dependent individuals and will consist of three consecutive phases: 1) the 2-week outpatient lead-in phase during which behavioral therapy will be administered; 2) the 15-21 day inpatient phase (during which participants will start study medication of levodopa,carbidopa and entacapone (LCE) and will undergo brain imaging and 3) the 24 weeks outpatient treatment trial. The purpose is to see if treatment with LCE may reverse baseline brain deficits and if this change is associated with clinical improvement. Hypothesis is that treatment with LCE, compared to placebo, increases abstinence from cocaine over a 12-week trial in combination with behavioral treatment with voucher incentives.","other_id":"#6022","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":21,"maximum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adult, age 21-50.\r\n\r\n          -  Meets DSM-IV criteria for current cocaine dependence, supported by a positive urine\r\n             for cocaine metabolites\r\n\r\n          -  Voluntarily seeking treatment for cocaine dependence\r\n\r\n          -  Absence of other medical or psychiatric disorders that are unstable and would\r\n             interfere with participation.\r\n\r\n          -  Absence of any suspicious skin changes, suggestive of melanoma, during the full body\r\n             exam\r\n\r\n          -  Able to give informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Current DSM-IV criteria of other substance use disorders with the exception of\r\n             nicotine dependence, and mild to moderate alcohol or cannabis abuse or dependence.\r\n             Alcohol or cannabis abuse or dependence may be included provided that cocaine is the\r\n             predominant problem, and medical detoxification is not indicated; alcohol and cannabis\r\n             use are common among cocaine dependent patients and their categorical exclusion would\r\n             impede recruitment and result in a sample of limited generalizability; secondary\r\n             analyses will explore whether they exert any moderating effects on the main findings.\r\n\r\n          -  Active psychiatric disorder which might interfere with participation or make\r\n             participation hazardous, including DSM-IV organic mental disorder, psychotic disorder,\r\n             bipolar disorder, recurrent severe MDD, OCD, or eating disorder. Participants with\r\n             depressive disorder (provided that the score on the Hamilton Depression Scale is less\r\n             than 20) and those with ADHD symptoms may be included, since these are common, often\r\n             reflect effects of chronic drug use, and may improve with behavioral treatment and\r\n             cessation or reduction of drug use.\r\n\r\n          -  Unstable medical disorders, or medical disorders that might interfere with study\r\n             participation, including seizure disorder.\r\n\r\n          -  Significant current suicidal risk or 1 or more suicide attempts within the past year\r\n\r\n          -  Concurrent treatment with psychotropic medications\r\n\r\n          -  Positive serum pregnancy test, lactation, or unwillingness to use a satisfactory\r\n             method of birth control\r\n\r\n          -  Baseline systolic BP of > 140 and < 100, diastolic BP > 90 and < 60 and baseline HR\r\n             greater than 90.\r\n\r\n          -  Any clinically significant heart abnormality or cardiovascular disease\r\n\r\n          -  History of glaucoma\r\n\r\n          -  History of melanoma or current suspicious undiagnosed skin lesions\r\n\r\n          -  History of allergic reaction or adverse reaction to study medications\r\n             (levodopa/carbidopa/entacapone; methylphenidate; raclopride).\r\n\r\n          -  Metal implants or paramagnetic objects contained within the body which may interfere\r\n             with the MRI scan as determined in consultation with a neuroradiologist and according\r\n             to the guidelines set forth in the following reference book commonly used by\r\n             neuroradiologists: \"Guide to MR procedures and metallic objects\" by Shellock\r\n\r\n          -  Lifetime exposure to radiation in the workplace, or history of participation in\r\n             nuclear medicine procedures, including research protocols\r\n\r\n          -  Individuals who are predominantly left handed. Based on a score <50 on the Edinburg\r\n             Handed Inventory (E.H.I.).\r\n\r\n        Inclusion Criteria(fMRI study-healthy controls):\r\n\r\n          -  Adult, age 21-50.\r\n\r\n          -  No current DSM-IV psychiatric or substance use disorders\r\n\r\n          -  Absence of other medical disorders that are unstable and would interfere with\r\n             participation.\r\n\r\n          -  Able to give informed consent.\r\n\r\n        Exclusion Criteria (fMRI study-healthy controls):\r\n\r\n          -  Current or recent DSM-IV psychiatric or substance use disorders\r\n\r\n          -  Past history of any major Axis I disorder (e.g., psychotic disorders, bipolar\r\n             disorder, recurrent major depressive disorder, OCD or eating disorders).\r\n\r\n          -  Unstable medical disorders, or medical disorders that might interfere with study\r\n             participation.\r\n\r\n          -  Concurrent treatment with psychotropic medications\r\n\r\n          -  Positive serum pregnancy test, lactation, or unwillingness to use a satisfactory\r\n             method of birth control *\r\n\r\n          -  Baseline systolic BP of > 140 and < 100, diastolic BP > 90 and < 60 and baseline HR\r\n             greater than 90.\r\n\r\n          -  Any clinically significant heart abnormality or cardiovascular disease\r\n\r\n          -  History of allergic reaction or adverse reaction to study medications\r\n             (methylphenidate; raclopride).\r\n\r\n          -  Metal implants or paramagnetic objects contained within the body which may interfere\r\n             with the MRI scan as determined in consultation with a neuroradiologist and according\r\n             to the guidelines set forth in the following reference book commonly used by\r\n             neuroradiologists: \"Guide to MR procedures and metallic objects\" by Shellock\r\n\r\n          -  Individuals who are predominantly left handed. Based on a score <50 on the Edinburg\r\n             Handed Inventory (E.H.I.).\r\n      ","sponsor":"New York State Psychiatric Institute","sponsor_type":"Other","conditions":"Cocaine Dependence","interventions":[{"intervention_type":"Drug","name":"Drug: levodopa carbidopa and entacapone (LCE)","description":"400mg/100mg/200mg, twice daily"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"matched placebo for LCE condition dosed twice daily"}],"outcomes":[{"outcome_type":"primary","measure":"Cocaine Urine Toxicology","time_frame":"collected 3x/week for 24 weeks of trial or for the duration of the participants involvement in the study.","description":"Abstinence will be assessed by urine toxicology results collected 3x/week during the 24 week trial or for the length of participation"},{"outcome_type":"primary","measure":"Retention in Treatment","time_frame":"12 weeks","description":"The number of participants who completed the 12-week medication phase of the study."}]}
{"nct_id":"NCT02235727","start_date":"2014-07-31","phase":"Phase 1","enrollment":37,"brief_title":"Safety and Tolerability of GBR 900 in a Single Ascending Dose Study in Healthy Subjects","official_title":"A Phase 1, Double-Blind, Randomised, Placebo-Controlled, Study to Evaluate the Safety and Pharmacokinetics of GBR 900 in Adult Healthy Volunteers","primary_completion_date":"2016-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-11-30","last_update":"2017-01-24","description":"A Single Dose Study of GBR 900 in Healthy Volunteers.","other_id":"GBR 900-101","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Body mass index (BMI) within the range 18.5-32 kg/m2 (inclusive); weight must be  50\r\n             kg.\r\n\r\n          2. Men and women aged between 18 and 55 years (inclusive). Female subjects must be of\r\n             non-child-bearing potential\r\n\r\n          3. Subjects who are otherwise healthy and free from clinically significant illness or\r\n             disease as determined by medical history, vital signs, physical examinations, and\r\n             other tests performed by the investigator.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Subjects with a history of neuropathy or otherwise present with risk factors for\r\n             neurological toxicity like chronic alcoholism or clinically significant neurological\r\n             (e.g. dementia, cognitive decline, seizure disorders) or psychiatric disorders.\r\n\r\n          2. Subjects with a recent history of live vaccination within the past 3 month or presence\r\n             of active infections within the previous month.\r\n\r\n          3. Subjects with previous exposure to antibody therapies or administration of\r\n             immunoglobulins (Ig) within 6 months of randomization.\r\n\r\n          4. Subjects with a history of or presence of inflammatory disease or rheumatological\r\n             diseases or joint diseases including OA or any undiagnosed pain in joints.\r\n\r\n          5. Subjects with a current and/or recent history of arthralgia or a history of\r\n             fibromyalgia, migraine, neuralgia, or systemic painful conditions, or medical or\r\n             arthritic conditions or any undiagnosed pain or systemic inflammatory disorders.\r\n\r\n          6. Any evidence of organ dysfunction or any clinically significant deviation from the\r\n             normal in history, physical or neurological determinations or investigations or has a\r\n             clinical condition or receiving therapy that, in the opinion of the Investigator,\r\n             would make the subjects unsuitable for study.\r\n      ","sponsor":"Glenmark Pharmaceuticals Ltd. India","sponsor_type":"Industry","conditions":"Healthy","interventions":[{"intervention_type":"Drug","name":"Drug: GBR 900"},{"intervention_type":"Drug","name":"Drug: Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"Drug related adverse events (AEs) or any serious AEs","time_frame":"71 days","description":"All treatment - emergent adverse events (TEAEs), occuring during the study, in terms of nature, onset, duration, severity, relationship and outcome of adverse events and serious adverse events in adult healthy volunteers from baseline to day 71."},{"outcome_type":"secondary","measure":"Maximum Concentration (Cmax) of single ascending doses of GBR 900 in adult healthy volunteers","time_frame":"Pre-dose and post-dose at planned multiple time points from 2 hours to 168 hours and from day 15 until day 71"},{"outcome_type":"secondary","measure":"Area Under Curve [(AUC (0-∞) and AUC (0-t)] of single ascending doses of GBR 900 in adult healthy volunteers","time_frame":"Pre-dose and post-dose at planned multiple time points from 2 hours to 168 hours and from day 15 until day 71"},{"outcome_type":"secondary","measure":"Half life (t1/2) of single ascending doses of GBR 900 in adult healthy volunteers","time_frame":"Pre-dose and post-dose at planned multiple time points from 2 hours to 168 hours and from day 15 until day 71"},{"outcome_type":"secondary","measure":"Immunogenicity of GBR 900","time_frame":"Pre-dose and at day 29, day 43, and day 71"}]}
{"nct_id":"NCT02203318","start_date":"2014-07-31","enrollment":60,"brief_title":"Can the Hypertrophy of Contralateral Testis Predict the Absence of the Non-palpable Testis in the Boys Aged From 6months to 18months of Age ?","primary_completion_date":"2015-05-31","study_type":"Observational","rec_status":"Completed","completion_date":"2015-06-30","last_update":"2016-11-01","description":"The aim of this study is to verify whether the hypertrophy of contralateral testis may predict the absence of the non-palpable testis in the boys younger than 24months of age. According to the previous studies of other countries, the large size of the contralateral testis of the nonpalpable testis has positive correlation woth the weak viability of the affected testis. We are going to evaluate this hypothesis with prospective study. 3 groups are going to be enrolled into this study ; non-palpable testis group(Group1), palpable but not normally descended testis group(group2) and control group(group3). The size of testis will be measured with Ultrasound and the length, width and the height will be measured before surgery at outpatient department. For the group 1 & 2, the viability of the affected testis will be evaluated and compared after surgery. In addition the comparison with normal control group is also going th be conducted.","other_id":"4-2014-0385","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"Male","minimum_age":0.5,"maximum_age":1.5,"population":"totally, 72 children : unpalpable testis : 24 children, palpable undescended testis : 24\r\n        children, normal control : 24 children","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. neonates or Infants who visited the out-patient clinic with nonpalpable or undescended\r\n             testis.(group 1, 2) aged from 6months to 18months\r\n\r\n          2. neonates or Infants aged from 6months to 18months with normal testis (volunteers,\r\n             Group3)\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. previous history of hormonal therapy.\r\n\r\n          2. chromosomal abnormality\r\n\r\n          3. previous history of abdomen or inguinal area surgery\r\n\r\n          4. children diagnosed with epididymitis or orchitis\r\n\r\n          5. twin baby\r\n\r\n          6. infants with premature (<37 weeks) birth history\r\n      ","sponsor":"Yonsei University","sponsor_type":"Other","conditions":"Focus of Study","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Size of contralateral testis","time_frame":"1 day of initial visit","description":"The testicular size is measured 3-dimensionally with ultrasonography. The length, width and height will be measured and the volume of testis will be evaluated."}]}
{"nct_id":"NCT01969461","start_date":"2014-07-31","phase":"N/A","enrollment":400,"brief_title":"Comparing the Effectiveness of Two Alcohol+Adherence Interventions for HIV+ Youth","official_title":"Comparing the Effectiveness of Two Alcohol+Adherence Interventions for HIV+ Youth","primary_completion_date":"2018-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2018-12-31","last_update":"2017-01-09","description":"Alcohol use among persons with HIV exacerbates health problems and accelerates HIV disease progression. Antiretroviral therapy (ART) is the single most important treatment for people living with HIV. However, ART adherence is suboptimal among adolescents and young adults living with HIV, the age group with the fastest growing rates of HIV infection, and great risk of engaging in risky behaviors such as alcohol use. The proposed study will compare the effectiveness of home-based versus clinic-based \"Healthy Choices\", a brief, 4- session intervention using Motivational Enhancement Therapy (MET) to address alcohol use, medication adherence, and health outcomes in youth living with HIV (YLH) using a repeated measures design. Unlike previous trials, Healthy Choices will be tested in a \"real world\" clinical setting and be delivered by community health workers (CHW: already members of the HIV care team). The study population will consist of YLH, ages 16-24, who are current patients at 5 ATN sites. Site staff will recruit potential participants. Youth will be randomized to receive Healthy Choices, either clinic-based or home-based delivered by the same CHW in both conditions. Outcomes are measured at baseline, 4-, 7-, and 13-months. Data collection for biological measures will be through medical record extraction, and self-reported measures will occur using a brief Web-based CASI (computer-administered self-interviewing) survey on an iPad. All intervention sessions will be audio-recorded for MITI fidelity coding, and investigators will support local supervisors during the active intervention phase. We will conduct qualitative interviews with CHWs, supervisors and organization leaders at the end of the trial to obtain information about barriers and facilitators of implementation. Thus, the proposed trial will allow us to use a Type 1 Effectiveness-implementation hybrid design to pilot a sustainable model of MI implementation in real-world youth care settings towards the goals of 1) examining the effectiveness, cost-effectiveness, and scalability of an efficacious behavioral intervention when delivered by CHWs in real-world adolescent HIV care settings; 2) gathering information about who responds under what contexts; and 3) increasing our understanding of the barriers and facilitators for future implementation. The primary hypothesis is that YLH receiving home-based MET will have greater improvements in alcohol use and viral load than YLH receiving clinic-based MET.","other_id":"1R01AA022891-01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":16,"maximum_age":24,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  HIV-infected\r\n\r\n          -  Ability to speak and understand English\r\n\r\n          -  Prescribed antiretroviral therapy\r\n\r\n          -  Detectable viral load in the last month\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Not fluent in English\r\n\r\n          -  History of sever learning disability, mental retardation, major psychiatric disorders\r\n             (e.g., schizophrenia, bipolar disorder, major depression with psychotic features,\r\n             etc).\r\n\r\n          -  Participation in another adherence intervention trial\r\n\r\n          -  On ART due to pregnancy\r\n      ","sponsor":"Wayne State University","sponsor_type":"Other","conditions":"HIV","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Motivational Enhancement Therapy (MET)","description":"The 4-session MET intervention will address alcohol use and HIV medication (ART) adherence. Sessions will be delivered in the clinic or the home by a CHW (outreach worker, etc) already providing services in the clinic. In sessions 1 and 2 (each behavior will get its own session), CHW will elicit the client's view of the problem using MI techniques, building motivation for change by eliciting and reinforcing change talk. The CHW will deliver feedback and discuss the consideration of a behavior change plan option, and the client sets the change plan goal and consolidates commitment. In the last two sessions, the CHW will review the change plan, continue to elicit and reinforce change talk, problem-solve barriers, consolidate commitment, and consider strategies to maintain behavior change."}],"outcomes":[{"outcome_type":"secondary","measure":"Change in Other Substance Use (not alcohol use) from Baseline to 9 months post intervention","time_frame":"Baseline, 4-, 7-, and 13-months","description":"Objective measures are cost prohibitive (e.g., MEMS, hair assays, STI tests, urine screens) for these secondary outcomes; thus we will use self-report and interviews that have been successful in our previous trials."},{"outcome_type":"primary","measure":"Change in Alcohol Use from Baseline to 9 months post intervention","time_frame":"Baseline, 4-, 7-, and 13-months","description":"We will use multiple methods of assessing use including calendar-based interview, biomarker, and self-report questionnaire."},{"outcome_type":"primary","measure":"Change in Viral Load from Baseline to 9 months post intervention","time_frame":"Baseline, 4-, 7-, and 13-months","description":"Viral load will be extracted from medical records, though we have budgeted to collect a percentage of viral loads for youth who drop out of care or transfer to a care setting where records are not available."},{"outcome_type":"secondary","measure":"Change in Medication Adherence from Baseline to 9 months post intervention","time_frame":"Baseline, 4-, 7-, and 13-months","description":"We will use self-report and interviews that have been successful in our previous trials."},{"outcome_type":"secondary","measure":"Change in Sexual Risk from Baseline to 9 months post intervention","time_frame":"Baseline, 4-, 7-, and 13-months","description":"We will use self-report and interviews that have been successful in our previous trials."},{"outcome_type":"other","measure":"Barriers and Facilitators of the MI Implementation Process","time_frame":"4 months post baseline","description":"The qualitative interview guide (with input from Dr. Norton, consultant) will focus on barriers and facilitators of implementation experienced at the individual, clinic, protocol team, and organizational level. Both positive and potentially negative outcomes will be elicited. Interviews will be conducted at the end of the MET intervention phase to assess sustainability."},{"outcome_type":"other","measure":"Barriers and Facilitators of the MI Implementation Process","time_frame":"13 months post Baseline","description":"The qualitative interview guide (with input from Dr. Norton, consultant) will focus on barriers and facilitators of implementation experienced at the individual, clinic, protocol team, and organizational level. Both positive and potentially negative outcomes will be elicited. Interviews will be conducted at the end of the trial to assess sustainability."}]}
{"nct_id":"NCT02247037","start_date":"2014-07-31","enrollment":68,"brief_title":"Patient-derived Xenograft (PDX) Modeling of Treatment Response for Triple Negative Breast Cancer","official_title":"Patient-derived Xenograft (PDX) Modeling of Treatment Response for Triple Negative Breast Cancer","primary_completion_date":"2019-01-22","study_type":"Observational","rec_status":"Completed","completion_date":"2019-01-22","last_update":"2020-07-07","description":"This study will determine if patient-derived tumor xenograft (PDX) mouse models can serve as a reliable model for treatment response for individual patients with triple negative breast cancer. The collection of patient tumor tissue will also provide insight into the mechanisms of therapeutic resistance for those individuals. Ultimately, this study will enhance our understanding of the genomic basis for treatment response for triple negative cancer on an individual basis, while having the potential to suggest new therapeutic options for high-risk triple negative breast cancer patients with residual disease post neoadjuvant.","other_id":"GCO 14-0686","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":90,"population":"Patients with Triple Negative Breast Cancer that are eligible for neoadjuvant chemotherapy\r\n        or have evidence of metastatic disease will be pursued for this protocol.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  a histological diagnosis of invasive triple negative breast cancer determined by\r\n             standard immunohistochemical analysis.\r\n\r\n          -  must be candidates for neoadjuvant chemotherapy according to standard of care\r\n             guidelines or have evidence of metastatic disease.\r\n\r\n          -  must agree to a biopsy for research purposes at time of diagnosis and to undergo\r\n             surgery at the hospitals of the Mount Sinai Health System.\r\n\r\n        Patients with the following MAY be eligible:\r\n\r\n        - a histological diagnosis of ER and/or PR positive breast cancer with an overall receptor\r\n        expression  30% breast cancer determined by standard immunohistochemical analysis\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  concurrent disease or condition that would make the patient inappropriate for study\r\n             participation,\r\n\r\n          -  any serious medical or psychiatric disorder that would interfere with the subject's\r\n             safety, or inability to provide informed consent.\r\n\r\n          -  vulnerable populations will not be included.\r\n      ","sponsor":"Icahn School of Medicine at Mount Sinai","sponsor_type":"Other","conditions":"Triple Negative Breast Cancer","interventions":[{"intervention_type":"Other","name":"Other: Chemotherapy","description":"Patients are treated with neoadjuvant chemotherapy as according to the standard of care guidelines. Patients with metastatic disease are treated according to standard of care guidelines."}],"outcomes":[{"outcome_type":"primary","measure":"Patient Tumor Response","time_frame":"Day 1","description":"Tumor response in patients will be categorized as: Progressive Disease, Static Response, Partial Response, Complete Response"},{"outcome_type":"secondary","measure":"Model Tumor Response","time_frame":"Day 1","description":"Tumor response in models will be categorized as: Progressive Disease, Static Response, Partial Response, Complete Response"}]}
{"nct_id":"NCT02178644","start_date":"2014-07-31","phase":"Phase 1","enrollment":29,"brief_title":"Pilot Trial of KD018 With Neo-Adjuvant Concurrent Chemo-Radiation Therapy in Patients With Locally Advanced Rectal Cancer","official_title":"Pilot Trial of KD018 With Neo-Adjuvant Concurrent Chemo-Radiation Therapy in Patients With Locally Advanced Rectal Cancer","primary_completion_date":"2019-09-20","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-09-20","last_update":"2020-10-08","description":"This pilot study focuses on KD018 and will investigate the effect of this agent on reducing the Gastrointestinal (GI) toxicity associated with combined modality therapy of locally-advanced rectal cancer.","other_id":"1404013708","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients must have histologically confirmed T3-T4 and N0-N2, M0 adenocarcinoma of the\r\n             rectum with the inferior margin within 16 cm from the anal verge.\r\n\r\n          -  Patients must have had a Transrectal ultrasound (TRUS)/endoscopic ultrasound (TEUS)\r\n             staging within two months prior to treatment start.\r\n\r\n          -  Patients must have had a pelvic MRI within 28 days prior to the initiation of\r\n             treatment.\r\n\r\n          -  Patient must have the ability to swallow multiple capsules.\r\n\r\n          -  Women of child bearing potential between the ages of 18 and 60 years of age must have\r\n             a negative urine pregnancy test prior to undergoing simulation in preparation for\r\n             radiation therapy to the pelvis.\r\n\r\n          -  ECOG performance status of 0 to 1 within 28 days prior to initiation of treatment.\r\n\r\n          -  Patients must have normal organ and marrow function as defined below. All laboratory\r\n             values must be obtained within 14 days prior to initiation of treatment:\r\n\r\n          -  absolute neutrophil count >= 1,500/mcL\r\n\r\n          -  platelets >= 100,000/mcL\r\n\r\n          -  hemoglobin >= 8.0 g/ dL\r\n\r\n          -  serum bilirubin < 1.5 times the upper limit of of normal (ULN)\r\n\r\n          -  serum AST, ALT < 2.5 times ULN\r\n\r\n          -  serum Creatinine  1.5 times ULN\r\n\r\n          -  The effects of radiation on the developing human fetus are known to be teratogenic.\r\n             For this reason, all women and sexually active men must agree to use adequate\r\n             contraception (hormonal or barrier method of birth control; abstinence) prior to study\r\n             entry and for the duration of study participation. Should a woman become pregnant or\r\n             suspect she is pregnant while participating in this study, she should inform her\r\n             treating physician immediately.\r\n\r\n          -  Patients must have the ability to understand and the willingness to sign a written\r\n             informed consent document.\r\n\r\n        Exclusion Criteria\r\n\r\n          -  History of clinically significant Crohn's disease or inflammatory bowel disease (IBD).\r\n\r\n          -  Active collagen vascular disease.\r\n\r\n          -  History of previous abdominal or pelvic radiation therapy.\r\n\r\n          -  History of previous systemic chemotherapy unless given curatively for other malignancy\r\n             now > 5 years without evidence of recurrence.\r\n\r\n          -  Patients with suspected or confirmed poor compliance, mental instability, or prior or\r\n             current alcohol or drug abuse deemed by the investigator to be likely to affect their\r\n             ability to sign the informed consent, or undergo study procedures will be excluded.\r\n\r\n          -  Pregnant women are excluded from this study because radiation has the potential for\r\n             teratogenic or abortifacient effects. Because there is an unknown but potential risk\r\n             for adverse events in nursing infants secondary to treatment of the mother with either\r\n             KD018 or Capecitabine, breastfeeding should be discontinued if the mother is treated.\r\n\r\n          -  Patients with known HIV infection or viral hepatitis.\r\n\r\n          -  Patients with Dihydropyrimidine dehydrogenase (DPD) deficiency.\r\n      ","sponsor":"Yale University","sponsor_type":"Other","conditions":"Rectal Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Chemo with concomitant Capecitabine and KD018","description":"Patients will receive a course of chemo-radiation with concomitant Capecitabine and KD018, and to compare this to the toxicity seen in patients treated with Capecitabine and radiation therapy alone, in patients with T3-T4 and N0-N2, M0 rectal cancer."}],"outcomes":[{"outcome_type":"primary","measure":"Grade 3-4 Toxicity Rate","time_frame":"Up to 10 Months","description":"Grade 3-4 toxicity rate will be described as greatest toxicity per patient/total patients evaluable for toxicity +/- 95% confidence interval."},{"outcome_type":"primary","measure":"pCR Rate","time_frame":"Up to 10 Months","description":"pCR (CR = Complete Response) rate will be defined as number of patients with pathologic complete response divided by number of patients treated (pCR IIT) and divided by those undergoing surgical resection (pCR actual) +/- 95% confidence interval."}]}
{"nct_id":"NCT02198183","start_date":"2014-07-31","enrollment":34,"brief_title":"Total Shoulder Arthroplasty Near-infrared Spectroscopy","official_title":"The Effects of Positive-pressure Ventilation on Cerebral Oxygenation and Cardiac Output in Total Shoulder Arthroplasty.","primary_completion_date":"2015-05-31","study_type":"Observational","rec_status":"Completed","completion_date":"2015-10-31","last_update":"2018-06-18","description":"The purpose of this study is to measure cerebral oxygenation and cardiac output of total shoulder replacement patients undergoing general anesthesia (GA) and positive-pressure ventilation (PPV). We hypothesize that cerebral desaturation occurs frequently during GA with PPV, but is rare during GA and spontaneous ventilation. We also hypothesize that cardiac output usually is well maintained under GA in the sitting position when epinephrine is used, but that decreased cardiac output increases the risk of cerebral desaturation.","other_id":"2014-003","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Total shoulder arthroplasty patients who are receiving surgery at the Hospital for Special\r\n        Surgery","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients 18-99 undergoing total shoulder arthroplasty\r\n\r\n          -  Planned general anesthesia + brachial plexus nerve block\r\n\r\n          -  Planned arterial catheter\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients younger than 18 years older and older than 99\r\n\r\n          -  Patients not intending to receive general anesthesia and peripheral nerve block\r\n\r\n          -  Indication for endotracheal tube\r\n\r\n          -  BMI  30\r\n\r\n          -  Ejection Fraction (if known) < 50%\r\n\r\n          -  Known significant restrictive or obstructive pulmonary disease\r\n\r\n          -  Patients with a history of transient ischemic attack (TIA) or stroke\r\n\r\n          -  Patients with recent signs or symptoms of myocardial ischemia\r\n\r\n               -  Current stress test positive for ischemia\r\n\r\n          -  Intolerance to study medications\r\n\r\n          -  pre-existing contraindication to regional anesthesia\r\n\r\n               -  infection at block site\r\n\r\n               -  pre-existing neurological injury to operative limb\r\n\r\n          -  Non-English speaking patients\r\n      ","sponsor":"Hospital for Special Surgery, New York","sponsor_type":"Other","conditions":"Cerebral Ischemia","interventions":[{"intervention_type":"Device","name":"Device: Casmed Fore-Sight Elite"},{"intervention_type":"Device","name":"Device: Non-invasive Cardiac Output Monitor (NICOM)"}],"outcomes":[{"outcome_type":"secondary","measure":"Cardiac Index (CI)","time_frame":"Day of surgery"},{"outcome_type":"secondary","measure":"Stroke Volume (SV)","time_frame":"Day of surgery"},{"outcome_type":"secondary","measure":"Mean Arterial Pressure (MAP)","time_frame":"Day of surgery"},{"outcome_type":"secondary","measure":"Fraction of inspired oxygen (FIO2)","time_frame":"Day of surgery"},{"outcome_type":"secondary","measure":"End Tidal Carbon Dioxide (ETCO2)","time_frame":"Day of surgery"},{"outcome_type":"secondary","measure":"Intravenous fluid volume","time_frame":"Day of surgery"},{"outcome_type":"secondary","measure":"Cardiac Output (CO)","time_frame":"Day of surgery"},{"outcome_type":"primary","measure":"Cerebral Desaturation Events","time_frame":"On day of surgery","description":"The primary outcome is defined as cerebral desaturation events (CDE) by >20% from baseline that lasts for 90 seconds or longer."}]}
{"nct_id":"NCT02498275","start_date":"2014-07-31","enrollment":14,"brief_title":"Effect of RO6871765 and RO7011785 on Immune Response With the Stimulation of Peripheral Blood Mononuclear Cells (PBMCs) in Chinese Healthy Volunteers and Chronic Hepatitis B Patients","primary_completion_date":"2014-08-31","study_type":"Observational","rec_status":"Terminated","completion_date":"2014-08-31","last_update":"2016-11-06","description":"This is an exploratory study to characterize the ex vivo immune response to RO6871765 or RO7011785 stimulation of peripheral blood mononuclear cells (PBMCs) extracted from healthy volunteers and chronic hepatitis B (CHB) patients.","other_id":"YP29018","observational_model":"Case-Control","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":65,"population":"Chinese population: healthy volunteers, treatment naive CHB patients and nucleoside or\r\n        nucleotide analogue treated CHB patients","criteria":"\n        Inclusion Criteria:\r\n\r\n        All population:\r\n\r\n          -  Chinese population\r\n\r\n          -  Adequate hematological function: platelet count greater than or equal to (>=) 100*10^9\r\n             per liter (/L), hemoglobin (Hb) >= 12 grams/deciliter (g/dL) (male) or >= 11 g/dL\r\n             (female), white blood cell (WBC) count >= 4*10^9/L and <= 11*10^9/L\r\n\r\n        Healthy volunteers:\r\n\r\n          -  Absence of evidence of any active or chronic disease\r\n\r\n          -  Negative hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis B surface\r\n             antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B envelope antigen\r\n             (HBeAg), hepatitis B envelope antiody (HBeAb) and hepatitis B core antibody (HBcAb)\r\n\r\n          -  Adequate liver function: transaminases alanine aminotransferase (ALT) <= 1.0 times the\r\n             upper limit of normal (ULN)\r\n\r\n        Treatment nave CHB patients:\r\n\r\n          -  HBsAg-positive (>=250 international unit/milliliter [IU/mL]), compensated liver\r\n             function, non-cirrhotic\r\n\r\n          -  HBeAg-positive, HBV DNA >= 200,000 IU/ml or equivalent copies/mL, ALT >1.5 times the\r\n             ULN and ALT <8 times the ULN\r\n\r\n        HBeAg-negative nucleoside/nucleotide analogue-treated CHB patients:\r\n\r\n          -  Subjects who HBeAg-seroconverted on nucleoside/nucleotide analogue therapy (treatment\r\n             for 1 to 3 years prior to enrollment) with HBV DNA <90 IU/mL or below a detection\r\n             level acceptable by both the sponsor and investigator for at least the preceding 6\r\n             months; HBeAg negative and HBeAb positive\r\n\r\n          -  HBsAg-positive (>=250 IU/mL), compensated liver function, non-cirrhotic -ALT <= 1*ULN\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Use of steroids or other immune suppressive agents within the last 4 weeks that would\r\n             impact the number/functions of white blood cells (WBC)\r\n\r\n          -  Any other diseases or clinical laboratory finding giving reasonable suspicion of a\r\n             disease or condition (including, but not limited to, cancer, lupus erythematosus,\r\n             rheumatoid arthritis, or other autoimmune disease) that could confound the result of\r\n             the study\r\n\r\n          -  Positive Hepatitis A immunoglobulin M (IgM) antibody, Hepatitis C antibody (HCV Ab) or\r\n             human immunodeficiency virus (HIV) at screening\r\n\r\n          -  Significant acute infection, example; influenza, acute gastrointestinal symptoms or\r\n             any other clinically significant illness within 2 weeks\r\n\r\n          -  Previous/concurrent treatment with interferon-based therapy for CHB\r\n      ","sponsor":"Hoffmann-La Roche","sponsor_type":"Industry","conditions":"Hepatitis B, Chronic","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Correlation coefficients between baseline toll-like receptor 7 (TLR7) expression and ex vivo immune response upon stimulation of PBMCs with RO6871765 or RO7011785 (in terms of cytokine release and gene expression)","time_frame":"Day 1"},{"outcome_type":"primary","measure":"Cytokine/chemokine production","time_frame":"Day 1"},{"outcome_type":"primary","measure":"Induction of interferon-responsive genes","time_frame":"Day 1"},{"outcome_type":"secondary","measure":"Number or percentages of T-lymphocytes in healthy volunteers and subjects with CHB","time_frame":"Screening Up to Day 1"},{"outcome_type":"secondary","measure":"Number or percentages of B-lymphocytes in healthy volunteers and subjects with CHB","time_frame":"Screening up to Day 1"},{"outcome_type":"secondary","measure":"Number or percentages of natural killer (NK) -cells in healthy volunteers and subjects with CHB","time_frame":"Screening up to Day 1"},{"outcome_type":"secondary","measure":"Number or percentages of myeloid dendritic cells (mDCs) in healthy volunteers and subjects with CHB","time_frame":"Screening up to Day 1"},{"outcome_type":"secondary","measure":"Number or percentages of plasmacytoid dendritic cells (pDCs) in healthy volunteers and subjects with CHB","time_frame":"Screening up to Day 1"},{"outcome_type":"secondary","measure":"Ex-vivo antiviral activity of PBMC supernatant","time_frame":"Day 1"}]}
{"nct_id":"NCT02190279","start_date":"2014-07-12","phase":"Early Phase 1","enrollment":116,"brief_title":"18F-DCFBC PET/CT in Prostate Cancer","official_title":"A Pilot Study of 18F-DCFBC PET/CT in Prostate Cancer","primary_completion_date":"2017-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-01-11","last_update":"2019-04-23","description":"Background: - Prostate cancer is the second leading cause of cancer deaths in American men. A chemical called a radiotracer helps doctors get images of this type of cancer. Researchers want to test a radiotracer called N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) (18F-DCFBC). Objective: - To see if the radiotracer 18F-DCFBC can identify sites of prostate cancer in the body. Eligibility: - Men ages 18 and over with prostate cancer. The cancer must be newly diagnosed, have relapsed, or has spread outside the prostate. Design: - Participants will be screened with physical exam and medical history. They will give a blood sample. - Participants will be divided into three groups. Group 1: people with cancer only in the prostate scheduled for surgical prostate removal or biopsy at National Institutes of Health (NIH). Group 2: people who had their prostate removed or had radiation therapy and now have a rising prostate-specific antigen (PSA) without other signs of disease. Group 3: people whose cancer has spread to other areas of the body. - Participants will have 18F-DCFBC injected into a vein then imaged in a positron emission tomography (PET)/computed tomography (CT) camera. During the scans, they will lie on their back on the scanner table. - Group 1 will have a magnetic resonance imaging (MRI) scan. A tube will be placed in the rectum. Coils may be wrapped around the outside of the pelvis. Participants will have a contrast agent injected through an intravenous line. - Group 3 will have another PET/CT scan with a different radiotracer, 18F NaF, within 21 days of the 18F-DCFBC scan to look for prostate cancer in the bone. - Group 3 will repeat the two PET/CT scans 4-6 months after the initial scans. - A few days after each scan, participants will be contacted for follow-up.","other_id":"140140","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":99,"population":"","criteria":"\n        -  INCLUSION CRITERIA:\r\n\r\n          -  Subject is greater than or equal to18 years old\r\n\r\n          -  Platelet count > 50,000/mm^3\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.\r\n\r\n          -  Ability to provide informed consent. All subjects must sign an informed consent form\r\n             indicating their understanding of the investigational nature and risks of the study\r\n             before any protocol-related studies are performed.\r\n\r\n          -  Categories\r\n\r\n               -  ARM 1 only\r\n\r\n                  ---For patients with presumed localized disease (any tumor (T), nodes 0 (N0),\r\n                  metastasized 0 (M0)), a multiparametric magnetic resonance imaging (MRI)\r\n                  (standard of care at the National Institutes of Health ((NIH) Clinical Center)\r\n                  must be performed within 4 months of the\r\n                  N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine\r\n                  ((18)F-DCFBC) (18F-DCFBC) injection with findings suggestive for prostate cancer\r\n                  and a prostate lesion at least 6mm or greater. Must have histopathologic\r\n                  confirmation of prostate cancer prior to 18F-DCFBC imaging.\r\n\r\n               -  ARM 2 only:\r\n\r\n                    -  For patients status post radiation therapy for prostate cancer, any\r\n                       prostatic-specific antigen (PSA) increase from post radiation therapy nadir\r\n\r\n                    -  OR\r\n\r\n                    -  For patients status post prostatectomy, a PSA >/=0.2 ng/ml\r\n\r\n                    -  Nonspecific or no evidence for disease on standard imaging modality\r\n\r\n               -  ARM 3 only:\r\n\r\n                    -  Patients must have identifiable metastatic disease on at least 1 clinically\r\n                       indicated imaging modality. If only soft tissue metastasis, one lesion must\r\n                       measure at least 6mm or greater. Patients must have confirmation of prostate\r\n                       cancer prior to 18FDCFBC imaging\r\n\r\n        Note: A patient who is eligible for one arm, subsequently may cross-over into a different\r\n        arm.\r\n\r\n        EXCLUSION CRITERIA:\r\n\r\n          -  Subjects for whom participating would significantly delay the scheduled standard of\r\n             care therapy\r\n\r\n          -  Subjects with any coexisting medical or psychiatric condition that is likely to\r\n             interfere with study procedures and/or results.\r\n\r\n          -  Subjects with severe claustrophobia unresponsive to oral anxiolytics\r\n\r\n          -  Other medical conditions deemed by the principal investigator (or associates) to make\r\n             the subject unsafe/ineligible for protocol procedures.\r\n\r\n          -  Subjects weighing > 350 lbs. (weight limit for scanner table), or unable to fit within\r\n             the imaging gantry\r\n\r\n          -  Serum creatinine > 2 times the upper limit of normal\r\n\r\n          -  Total bilirubin > 2 times the upper limit of normal\r\n\r\n          -  Liver transaminases (alanine aminotransferase (ALT), aspartate aminotransferase (AST))\r\n             greater than 3 times the upper limit of normal\r\n      ","sponsor":"National Cancer Institute (NCI)","sponsor_type":"NIH","conditions":"Prostatic Neoplasms|Prostate Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: 18F DCFBC","description":"Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec."},{"intervention_type":"Drug","name":"Drug: Sodium (Na)18F positron emission tomography (PET)/computed tomography (CT)"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants With Local Recurrence, Lymph Node Metastases or Distant Metastatic Sites Detected by N-[N-[(S)-1,3-dicarboxypropyl]Carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) Imaging","time_frame":"1 hour and 2 hour timepoints at baseline","description":"Any abnormal focus of 18F-DCFBC uptake higher than the surrounding background and not associated with physiological uptake was considered positive for prostate cancer, and each was classified as local recurrence, lymph node metastases or distant metastatic sites."},{"outcome_type":"primary","measure":"Number of Lesions Detected by N-[N-[(S)-1,3-dicarboxypropyl]Carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC)","time_frame":"1 hour and 2 hour timepoints at baseline","description":"Any abnormal focus of 18F-DCFBC uptake higher than the surrounding background and not associated with physiological uptake was considered a positive lesion for prostate cancer.The measure would be compared with other imaging or pathology."},{"outcome_type":"secondary","measure":"Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)","time_frame":"Date treatment consent signed to date off study, approximately 42 months and 21 days","description":"Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned."},{"outcome_type":"secondary","measure":"Number of Detectable Lesions in Bone With Respect to 18F-DCFBC Imaging and/or Na18F Positron Emission Tomography (PET)/Computed Tomography (CT) in Patients With Known Metastatic Disease","time_frame":"3 months","description":"18F-DFBC and conventional imaging was used to identify positive lesions in bone."},{"outcome_type":"secondary","measure":"Average Standardized Uptake Value (SUVmax) for Primary Prostate Cancer Patients Compared to Benign Prostatic Hyperplasia (BPH)","time_frame":"1 hour and 2 hour post injection (p.i.)","description":"Primary prostate cancer was compared to BPH nodules and normal prostate tissue using a one-way analysis of variance (Anova). Negative uptake is defined as tumor uptake less than adjacent background soft tissue, or blood pool for lymph nodes."},{"outcome_type":"secondary","measure":"Median Tumor Foci Size in Suspected Localized Prostate Cancer Patients Undergoing Prostatectomy","time_frame":"1 month","description":"Tissue was obtained and stained with hematoxylin-eosin. The resulting whole mount specimens were correlated with MRI and PET/CT imaging. For each dominant/index tumor (largest tumor with highest Gleason score) was determined."},{"outcome_type":"secondary","measure":"Detectability of Suspicious Prostate Cancer Lesions in Suspected Localized Prostate Cancer Patients With Prostate Gland","time_frame":"3 months","description":"Visualizing positive lesions with DCFBC and mpMRI."},{"outcome_type":"secondary","measure":"Detectability of Suspicious Tumors Based on Prostate Specific-Antigen (PSA) Levels in the Biochemical Recurrence Group","time_frame":"3 months","description":"Visualizing positive lesions as a function of PSA value. Undetectable PSA is normal in this population."}]}
{"nct_id":"NCT02041845","start_date":"2014-07-08","phase":"N/A","enrollment":177,"brief_title":"Two Schedules of Hyperfractionated Thoracic Radiotherapy in Limited Disease Small Cell Lung Cancer","official_title":"A Randomized Phase II Study Comparing Two Schedules of Hyperfractionated Thoracic Radiotherapy in Limited Disease Small Cell Lung Cancer","primary_completion_date":"2020-07-29","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2023-07-29","last_update":"2021-09-01","description":"The majority of patients with limited disease small cell lung cancer (SCLC) experience recurrent disease despite receiving concurrent chemoradiotherapy. New agents and dose-escalation of chemotherapy have not provided a survival benefit. Local failure accounts for high proportion of recurrences. Improved thoracic radiotherapy (TRT) might increase local control and thus reduce the recurrence rate and prolong survival. Positron emission tomography (PET CT) is better for staging of SCLC than computer tomography (CT) and bone scan. More precise localization of tumors leads to more accurate definition of target volumes for TRT and reduce the radiation dose to normal tissue. A large proportion of patients relapse and die within one and two year after therapy. Few patients survive longer than three years. Thus, two-year survival is considered a clinically highly relevant measure of efficacy. The aim of this study is to compare two schedules of TRT with respect to local control, progression free survival, overall survival, toxicity and health-related quality of life. In addition patients who have the best outcomes and tolerate chemoradiotherapy will be characterized (e.g. clinical characteristics, blood biomarkers, body composition).","other_id":"2013/2163","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically or cytologically confirmed small-cell lung cancer (SCLC)\r\n\r\n          -  Limited disease (stage II-III)\r\n\r\n          -  Stage I if ineligible for surgery\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) Performance 0-2\r\n\r\n          -  Measureable disease according to the Response Evaluation Criteria In Solid Tumors\r\n             (RECIST) 1.1\r\n\r\n          -  Adequate organ function defined as: (a) Serum serum alanine transaminase (ALT)  3 x\r\n             upper limit of normal (ULN); (b) Total serum bilirubin  1.5 x ULN; (c) Absolute\r\n             neutrophil count (ANC)  1.5 x 109/L; (d) Platelets  100 x 109/L; (e) Creatinine <\r\n             100 mol/L and calculated creatinine-clearance > 50 ml/min. If calculated\r\n             creatinine-clearance is < 50 ml/min, an ethylene diamine tetra-acetic acid (EDTA)\r\n             clearance should be performed.\r\n\r\n          -  Pulmonary function: Forced Expiratory Volume in One Second (FEV1) > 1 l or 30 % of\r\n             predicted value and diffusing capacity of the lungs for carbon monoxide (DLCO) > 30 %\r\n             of predicted value\r\n\r\n          -  All fertile patients should use safe contraception\r\n\r\n          -  Written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  prior systemic therapy for small-cell lung cancer\r\n\r\n          -  Previous radiotherapy to the thorax\r\n\r\n          -  malignant cells in pericardial or pleural fluid (at least one sample should be\r\n             analysed if pleural fluid is present\r\n\r\n          -  serious concomitant systemic disorders (for example active infection, unstable\r\n             cardiovascular disease) that in the opinion of the investigator would compromise the\r\n             patient's ability to complete the study or interfere with the evaluation of the\r\n             efficacy and safety of the study treatment\r\n\r\n          -  conditions - medical, social, psychological - which could prevent adequate information\r\n             and follow-up\r\n\r\n          -  clinically active cancer other than SCLC. Hormonal therapy for prostate cancer or\r\n             breast cancer and basocellular carcinoma of the skin is allowed\r\n\r\n          -  pregnancy, lactation\r\n      ","sponsor":"Norwegian University of Science and Technology","sponsor_type":"Other","conditions":"Small Cell Lung Carcinoma","interventions":[{"intervention_type":"Radiation","name":"Radiation: 45 Gy in 30 fractions","description":"3D conformal thoracic radiotherapy at a total dose of 45 Gy in 30 fractions, 2 fractions per day, 5 days a week"},{"intervention_type":"Radiation","name":"Radiation: 60 Gy in 40 fractions","description":"3D conformal thoracic radiotherapy at a total dose of 60 Gy in 40 fractions, 2 fractions per day, 5 days a week. If doses to organs at risk exceed normal tissue tolerance, the dose may be lowered to a minimum of 54 Gy."}],"outcomes":[{"outcome_type":"primary","measure":"survival","time_frame":"2 years","description":"measured for all patients from the date of the first day of the first course of chemotherapy until the date of death from any cause (or last contact/observation if lost to follow-up - or the follow-up is completed before all patients die)."},{"outcome_type":"secondary","measure":"progression free survival (PFS)","time_frame":"2 years","description":"measured for all patients from the date of the first day of the first course of PE to the first date of objective progression (according to RECIST 1.1) of disease or of death from any cause. For each patient who has not died or has non-progression at the cut-off date for the analysis, PFS will be censored at the date of the patient's last tumor assessment prior to the cut-off date. Statistical survival analyses will be done with Kaplan Meier. Log rank test will be used for comparing groups."},{"outcome_type":"secondary","measure":"Local control","time_frame":"2 years","description":"Proportion of all patients who experience disease recurrence within radiotherapy fields assessed by comparing dose plans and follow-up CT scans."},{"outcome_type":"secondary","measure":"overall survival","time_frame":"3 years","description":"measured for all patients from the date of the first day of the first course of chemotherapy until the date of death from any cause (or last contact/observation if lost to follow-up - or the follow-up is completed before all patients die)."},{"outcome_type":"secondary","measure":"toxicity","time_frame":"2 years","description":"assessed for all patients receiving at least one course of chemotherapy from reported blood values and adverse event. Classified and graded according to CTCAE 4.0. Compared using Pearson's Chi-square and Fischer's exact tests."},{"outcome_type":"secondary","measure":"health related quality of life (HRQoL)","time_frame":"From baseline, before and after radiotherapy and then at follow-up every 3 months until 24 months after start of chemotherapy. Then every 6 months until 5 year after start of therapy","description":"assessed from completed questionnaires. Patients will report HRQoL on the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 and the lung cancer specific module LC13. The QLQ-C30 measures fundamental aspects of HRQoL and symptoms commonly reported by cancer patients in general, the LC13 measures symptoms commonly associated with lung cancer and its treatment.\r\nAll HRQoL scores will be transformed to a scale from 0 to 100 according to the EORTC scoring manual. A difference in mean scores of >10 is considered clinically relevant. For group comparisons of baseline scores during and after chemotherapy, and changes in scores from baseline, the Mann-Whitney test will be used. Primary HRQoL-endpoints are dysphagia and dyspnea."},{"outcome_type":"other","measure":"Exploratory analyses of associations between characteristics and blood biomarkers - and outcomes of therapy","time_frame":"3 years","description":"All patients will be included in these analyses. Blood will be collected, the study group will define which markers to analyze when all patients have been enrolled."}]}
{"nct_id":"NCT02343913","start_date":"2014-06-30","phase":"N/A","enrollment":329,"brief_title":"Simplifying Menstrual Regulation (MR): Post Abortion Care in Pakistan","official_title":"Simplifying Menstrual Regulation (MR): Exploring the Role of At-home Semi-quantitative Pregnancy Tests for Follow-up to Menstrual Regulation Service Provision in Pakistan: Post Abortion Care (PAC)","primary_completion_date":"2014-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-12-31","last_update":"2015-03-03","description":"This study is an additional component of protocol 6005, titled Simplifying Menstrual Regulation (MR): Exploring the role of at-home semi-quantitative pregnancy tests for follow-up to menstrual regulation service provision in Pakistan. The study seeks to pilot a self-assessment checklist that will help women, who receive medical services for incomplete abortion, correctly identify warning signs and symptoms and determine whether to return to the clinic. The checklist can serve as a useful resource to help with the timely identification of women who need additional care and can help streamline service delivery. In addition, this study will provide important data on the role of misoprostol at varying levels of health services offering an array of treatments for incomplete abortion.","other_id":"6005a","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Health Services Research","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Vaginal bleeding during pregnancy\r\n\r\n          -  Open cervical os.\r\n\r\n          -  No signs of severe infection, defined as at least one of the following of: 1) foul\r\n             smelling discharge, 2) fever > 38 degrees C , 3) uterine tenderness\r\n\r\n          -  No hemodynamic disturbances (pulse >110/min and systolic bp <100)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Suspected to have an ectopic pregnancy\r\n\r\n          -  Unable to provide informed consent\r\n      ","sponsor":"Gynuity Health Projects","sponsor_type":"Other","conditions":"Medical Abortion","interventions":[{"intervention_type":"Device","name":"Device: PAC checklist"}],"outcomes":[{"outcome_type":"primary","measure":"Identify symptoms","time_frame":"1 week","description":"Proportion of women able to use a checklist to correctly identify any signs and symptoms that warrant immediate return to the clinic and additional care"},{"outcome_type":"secondary","measure":"Acceptability of treatment","time_frame":"1 week","description":"Proportion of women who find the treatment of 400 sublingual misoprostol for incomplete abortion acceptable and satisfactory."},{"outcome_type":"secondary","measure":"Uptake of contraceptive use","time_frame":"1 week","description":"Proportion of women who receive a contraceptive method after receipt of 400 sublingual misoprostol"}]}
{"nct_id":"NCT01982149","start_date":"2014-06-30","enrollment":27,"brief_title":"Incorporation of Genetic Expression of Airway Epithelium With CT Screening for Lung Cancer","official_title":"Incorporation of Genetic Expression of Airway Epithelium With CT Screening for Lung Cancer","primary_completion_date":"2019-05-31","study_type":"Observational","rec_status":"Terminated","completion_date":"2019-05-31","last_update":"2020-07-24","description":"Lung cancer, largely the result of cigarette smoking, is the leading cause of cancer death in the United States, killing over 160,000 people in 2010, more than breast, colorectal, and prostate cancer combined. Since only 10% of heavy smokers develop lung cancer and 20% of lung cancers develop in nonsmokers, it is thought that genetic predisposition plays an important role. This study proposes to examine the genetic correlation between nasal and bronchial epithelium and to identify a patient's risk for lung cancer earlier.","other_id":"1305013973","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"New York Metropolitan area residents","criteria":"\n        Inclusion Criteria:\r\n\r\n        HEALTHY VOLUNTEER RESEARCH SUBJECTS\r\n\r\n          -  All study subjects should be able to provide informed consent\r\n\r\n          -  Males or females ages 18 years and older\r\n\r\n          -  Must provide HIV informed consent\r\n\r\n        VOLUNTEER RESEARCH SUBJECTS WITH LUNG DISEASE\r\n\r\n          -  Must provide informed consent\r\n\r\n          -  Males and females age 18 years and older\r\n\r\n          -  Lung disease proven by at least one of the following: symptoms consistent with\r\n             pulmonary disease; (2) chest X-rays consistent with lung disease; (3) pulmonary\r\n             function tests consistent with lung disease; (4) lung biopsy consistent with lung\r\n             disease; (5) family history of lung disease; and/or (6) diseases of organs with known\r\n             association with lung disease\r\n\r\n          -  Must provide HIV informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n        HEALTHY VOLUNTEER RESEARCH SUBJECTS\r\n\r\n          -  Individuals not deemed in good overall health by the investigator will not be accepted\r\n             into the study.\r\n\r\n          -  Habitual use of drugs and/or alcohol within the past six months (Acceptable: -\r\n             Marijuana one time in three months; average of two alcoholic beverages per day; drug\r\n             and/or alcohol abuse is defined as per the DSM-IV Substance Abuse Criteria).\r\n\r\n          -  Individuals with history of chronic lung disease, including asthma or with recurrent\r\n             or recent (within three months) acute pulmonary disease will not be accepted into the\r\n             study.\r\n\r\n          -  Individuals with allergies to atropine or any local anesthetic will not be accepted\r\n             into the study.\r\n\r\n          -  Individuals with allergies to pilocarpine, isoproterenol, terbutaline, atropine or\r\n             aminophylline will not be accepted into the study.\r\n\r\n          -  Females who are pregnant or nursing will not be accepted into the study\r\n\r\n        VOLUNTEER RESEARCH SUBJECTS WITH LUNG DISEASE\r\n\r\n          -  Any history of allergies to xylocaine, lidocaine, versed, valium, atropine,\r\n             pilocarpine, isoproterenol, terbutaline, aminophylline, or any local anesthetic will\r\n             not be included in the study.\r\n\r\n          -  Habitual use of drugs and/or alcohol within the past six months (Acceptable: Marijuana\r\n             one time in three months; average of two alcoholic beverages per day; drug and/or\r\n             alcohol abuse is defined as per the DSM-IV Substance Abuse Criteria)\r\n\r\n          -  Females who are pregnant or nursing\r\n      ","sponsor":"Weill Medical College of Cornell University","sponsor_type":"Other","conditions":"COPD|Chronic Obstructive Pulmonary Disease","interventions":[{"intervention_type":"Genetic","name":"Genetic: Group 1","description":"Perform gene expression studies of airway epithelium to correlate findings in the gene expression of nasal bronchial epithelium"},{"intervention_type":"Genetic","name":"Genetic: Group 2","description":"Correlate gene expression data from nasal and bronchial epithelium"},{"intervention_type":"Genetic","name":"Genetic: Group 3","description":"Correlated nasal epithelial gene expression with the ultimate diagnosis (by biopsy or surgery)"}],"outcomes":[{"outcome_type":"primary","measure":"Measure the correlation among gene expression levels between nasal and bronchial epithelium on an individual gene and multivariate basis","time_frame":"One year","description":"Measure the correlation among gene expression levels between nasal and bronchial epithelium on an individual gene and multivariate basis"}]}
{"nct_id":"NCT02323659","start_date":"2014-06-30","phase":"Phase 4","enrollment":100,"brief_title":"Comparison of Methotrexate Versus Interferon-alfa 2b in Patients With Primary Cutaneous T-cell Lymphomas","official_title":"Comparison of Methotrexate Versus Interferon-alfa 2b on Efficacy, Safety and Quality of Life in Patients With Primary Cutaneous T-cell Lymphomas","primary_completion_date":"2017-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2017-12-31","last_update":"2017-07-17","description":"Comparison of methotrexate versus interferon-alfa 2b on efficacy, safety and quality of life in patients with primary cutaneous T-cell lymphomas after failure of topical or phototherapy treatment.","other_id":"PLRG-14","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Histologically confirmed primary cutaneous T-cell lymphoma (CTCL)\r\n\r\n          2. Age  18 years\r\n\r\n          3. Performance status WHO<=2\r\n\r\n          4. Subject must have adequate bone marrow, renal and hepatic function\r\n\r\n          5. Topical and phototherapy treatment failure in the past\r\n\r\n          6. Signed informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Subject has received prior systemic methotrexate or interferon therapy\r\n\r\n          2. Unacceptable methotrexate or interferon treatment toxicity in the past\r\n\r\n          3. Inadequate bone marrow, renal or hepatic function as follows:\r\n\r\n               -  Bone Marrow: Absolute neutrophil count (ANC) < 1,500/mm 3 (1.5  10 9 /L);\r\n                  Platelets <100,000/mm 3 (100  10 9 /L); Hemoglobin < 9.0 g/dL (1.4 mmol/L);\r\n\r\n               -  Renal function: Creatinine >1.5 x Upper limit of normal (ULN)\r\n\r\n               -  Hepatic function: Aspartate and Alanine transaminase (AST and ALT) >3 ULN;\r\n                  bilirubin > 1.5  ULN\r\n\r\n               -  Active hepatitis B or hepatitis C\r\n\r\n          4. anorexia\r\n\r\n          5. major depression with suicidal ideation or suicide attempt in the past\r\n\r\n          6. Symptomatic congestive heart failure\r\n\r\n          7. Epilepsia or other symptomatic central nervous system dysfunction\r\n\r\n          8. active skin infection not related to underlying CTCL, active Tuberculosis, HIV\r\n             infection\r\n\r\n          9. Subject is pregnant or lactating\r\n\r\n         10. Psychiatric illness/social situation that would limit compliance with study\r\n             requirements\r\n      ","sponsor":"Polish Lymphoma Research Group","sponsor_type":"Other","conditions":"Lymphoma, T-Cell, Cutaneous|Mycosis Fungoides","interventions":[{"intervention_type":"Drug","name":"Drug: Methotrexate","description":"Methotrexate 20mg per dose, administered orally, once every week"},{"intervention_type":"Drug","name":"Drug: Interferon Alfa-2b","description":"Interferon Alfa-2b 3 million international units (MIU), administered 3 times per week"}],"outcomes":[{"outcome_type":"primary","measure":"Objective response rate as measured by the modified Severity Weighted Assessment Tool (mSWAT scoring system)","time_frame":"3 years","description":"Evaluation according to modified Severity Weighted Assessment Tool (mSWAT scoring system)"},{"outcome_type":"secondary","measure":"Number of Participants With Adverse Events","time_frame":"3 years"},{"outcome_type":"secondary","measure":"Quality of Life as measured by the Dermatology Life Quality Index (DLQI)","time_frame":"3 years","description":"Evaluation according to Dermatology Life Quality Index (DLQI)"}]}
{"nct_id":"NCT02158221","start_date":"2014-06-30","phase":"N/A","enrollment":32,"brief_title":"PACAP Induced Migraine Attacks in Patients With High and Low Genetic Load","official_title":"PACAP Induced Migraine Attacks in Patients With High and Low Genetic Load","primary_completion_date":"2014-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-12-31","last_update":"2015-02-10","description":"The investigators hypothesized that migraine without patients with many genetic loci associated with migraine (high genetic load) would be more sensitive and get provoked more migraine attacks by PACAP compared to patients with few genetic loci associated with migraine (low genetic load).","other_id":"H-2-2013-043","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Migraine without aura patients genotyped for the 12 newly idetified gene variants\r\n             associated with migraine.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Other primary headache\r\n\r\n          -  A history of cerebrovascular disease and other CNS- disease\r\n\r\n          -  A history suggesting ischaemic heart disease\r\n\r\n          -  Serious somatic and mental disease\r\n\r\n          -  Hypo- or hypertension\r\n\r\n          -  Abuse of alcohol or medicine (opioid analgesics).\r\n\r\n          -  Pregnant or breastfeeding women.\r\n      ","sponsor":"Danish Headache Center","sponsor_type":"Other","conditions":"Migraine Without Aura","interventions":[{"intervention_type":"Drug","name":"Drug: PACAP","description":"Pituitary adenylate cyclase-activating polypeptide (PACAP)"}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of migraine attacks induced by PACAP in patients with high and low genetic load.","time_frame":"Change from baseline in headache intensity at 12 hours after the start of infusion of PACAP","description":"The difference in incidence of migraine-like attacks after PACAP between patients with and without high genetic load and patients with low genetic load using verbal rating scale (VRS)."},{"outcome_type":"secondary","measure":"Incidence of headache induced by PACAP in patients with high and low genetic load.","time_frame":"Change from baseline in headache intensity at 12 hours after the start of infusion of PACAP","description":"The difference in area under the curve (AUC) for headache intensity scores (0-12 hours) after infusion of PACAP"}]}
{"nct_id":"NCT02132065","start_date":"2014-06-30","phase":"N/A","enrollment":30,"brief_title":"Unilateral Dual TAP (Transverses Abdominal Plane) Blok i Forbindelse Med Laparoskopisk Nyre Operation","official_title":"Unilateral Dual TAP (Transverses Abdominal Plane) Blok i Forbindelse Med Laparoskopisk Nyre Operation","primary_completion_date":"2017-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-06-01","last_update":"2018-01-24","description":"Unilaterally Dual TAP (Transversus abdominis plane) block after radical nephrectomy, assessment of benefit and opioid reduction. Transverses Abdominal Plane (TAP) Block is a relatively new regional technique which infiltrates local anesthetic between the internal oblique and transverse abdominis muscles and provides analgesia to the parietal peritoneum as well as the skin and muscles of the anterior abdominal wall (1). An Ultrasound-guided bilateral dual transversus abdominis plane block (Dual TAP block) had been reported by Boerglum et al (2,3), in which regional anesthesia postoperatively can be provided to the upper (Th6-Th9) and the lower (Th10-Th12) abdominal wall bilaterally using a four-point single-shot technique. Pain has a wide spectrum of effects on the body. Inadequately controlled postoperative pain may have harmful physiologic, psychological consequences which potentially increase the morbidity and mortality (4,5). It has been recognized that inadequately treated postoperative pain may lead to chronic pain which is often misdiagnosed and neglected (6,7). Chronic postsurgical pain reported in 20% of patients, 6 months after nephrectomy (8). Hypothesis: The use of unilaterally dual TAP block will reduce the VAS score for pain and the need of morphine postoperatively after radical nephrectomy. Purpose: To evaluate the analgesic efficacy of unilaterally dual TAP block as an adjuvant to routine analgesic. To assess the difference in morphine usage in the first 48 hours after radical nephrectomy with or without applying of unilaterally dual TAP block.","other_id":"SJ-386","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        -Any patient undergoing laparoscopic nephrectomy- -Age ranges 18-80- -Can read and\r\n        understand Danish- -Able to give informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n        -History of relevant drug allergy- -Inability to understand written consent forms or give\r\n        consent- -Age less than 18 or over 80- -Any conversion to open surgery-\r\n\r\n        -Patients included in ambulant nephrectomy project.\r\n      ","sponsor":"Zealand University Hospital","sponsor_type":"Other","conditions":"Laparoscopic Nephrectomy|TAP Block","interventions":[{"intervention_type":"Drug","name":"Drug: TAP block","description":"Patients will be scheduled to receive routine analgesic and an unilaterally dual TAP block with 2 points injections of 15 ml of 0,375 % Ropivacain( in total 30 ml 0,375% Ropivacain) in the same side of nephrectomy."}],"outcomes":[{"outcome_type":"primary","measure":"Pain score","time_frame":"24 hours","description":"The use of unilaterally dual TAP block will reduce the VAS score for pain and the need of morphine postoperatively after radical nephrectomy"}]}
{"nct_id":"NCT02206841","start_date":"2014-06-30","enrollment":1000,"brief_title":"Establishment of NAFLD Cohort and Development of Fibrosis Markers","official_title":"Establishment of Non-alcoholic Fatty Liver Disease Cohort and Development of Markers to Predict Histologic Progression of Liver Fibrosis","primary_completion_date":"2022-08-31","study_type":"Observational [Patient Registry]","rec_status":"Recruiting","completion_date":"2022-12-31","last_update":"2021-03-17","description":"This study is designed for establishment of non-alcoholic fatty liver disease patients cohort to development of markers to predict histologic progression of liver fibrosis.","other_id":"NAFLD_cohort","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"Non-alcoholic fatty liver disease","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with histologically confirmed fatty liver disease\r\n\r\n          -  Patients with radiologically confirmed fatty liver disease\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of significant alcohol consumption\r\n\r\n          -  Viral hepatitis\r\n\r\n          -  Autoimmune hepatitis\r\n\r\n          -  Metabolic diseases (e.g. hemochromatosis, M. Wilson, alpha 1-antitrypsin deficiency)\r\n\r\n          -  Hepatotoxic medication (e.g. amiodarone)\r\n      ","sponsor":"Seoul National University Boramae Hospital","sponsor_type":"Other","conditions":"Fibrosis of Liver","interventions":[{"intervention_type":"Procedure","name":"Procedure: Liver biopsy","description":"Percutaneously liver biopsy will be performed for evaluate steatosis and fibrosis."},{"intervention_type":"Device","name":"Device: ARFI","description":"Acoustic radiation force impulse (ARFI) imaging will be performed for evaluate fibrosis of liver."},{"intervention_type":"Device","name":"Device: SWE","description":"Supersonic shear wave elastography (SWE) will be performed for evaluate fibrosis of liver."},{"intervention_type":"Device","name":"Device: Transient elastography","description":"Transient elastography will be performed for evaluate fibrosis of liver."}],"outcomes":[{"outcome_type":"primary","measure":"histologic steatosis and fibrosis grade","time_frame":"baseline","description":"We will evaluate fibrosis using laboratory examination, radiologic evaluation and liver tissue pathology."},{"outcome_type":"secondary","measure":"Development of markers for hepatic fibrosis progression","time_frame":"baseline and every 6 months (up to 1year)","description":"We will analysis and development fibrosis markers by obtained blood sample and liver tissue,"}]}
{"nct_id":"NCT02622477","start_date":"2014-06-30","enrollment":12,"brief_title":"Clinical Progression of Mild to Moderate Idiopathic Pulmonary Fibrosis (IPF) Under a Therapy With Esbriet (Pirfenidone)","official_title":"Clinical Course of Treatment With ESBRIET in Patients With Mild to Moderate IPF","primary_completion_date":"2016-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2016-12-31","last_update":"2017-02-28","description":"The purpose of the study was to assess the clinical outcome of patients with a mild to moderate IPF after a one-year therapy with Esbriet (Pirfenidone).","other_id":"ML30016","observational_model":"Cohort","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","population":"Adult patients with diagnosis of mild to moderate idiopathic pulmonary fibrosis (IPF), who\r\n        had previously not yet been treated with Pirfenidone","criteria":"\n        Inclusion Criteria:\r\n\r\n        Adult patients with confident diagnosis of mild to moderate IPF, who had previously not yet\r\n        been treated with Pirfenidone\r\n\r\n        Exclusion Criteria:\r\n\r\n        Hypersensitivity to the active substance or one of the other excipients of Pirfenidone\r\n        Concomitant use of Fluvoxamin Severe hepatic impairment or end stage liver disease Severe\r\n        renal impairment (Creatinine-Clearance <30 ml/min) or end stage renal disease requiring\r\n        dialysis Simultaneous participation in interventional studies Previously treated with\r\n        Pirfenidone for longer than 30 days\r\n      ","sponsor":"Hoffmann-La Roche","sponsor_type":"Industry","conditions":"Idiopathic Pulmonary Fibrosis","interventions":[{"intervention_type":"Drug","name":"Drug: Pirfenidone","description":"This is an observational study. Pirfenidone is available as an 267 mg capsule for oral administration."}],"outcomes":[{"outcome_type":"primary","measure":"Categorical Decrease Of The Vital Capacity And Forced Volume Capacity (>= 5 % Respectively 10% Compared To The Previous Examination Findings) Under Treatment","time_frame":"-3 to 8 months before inclusion, appointment 0, and 3, 6, 9 and 12 months after appointment"},{"outcome_type":"primary","measure":"Categorical Decrease of the 6-Minute Walking Distance (>= 50 Metres Compared to the Previous Examination Findings) Under Treatment","time_frame":"Appointment 0, and 3, 6, 9 and 12 months after appointment 0"},{"outcome_type":"primary","measure":"Disease Progression","time_frame":"Appointment 0, and 3, 6, 9 and 12 months after appointment 0"},{"outcome_type":"secondary","measure":"Progression of the LCQ (Leicester Cough Questionnaire)","time_frame":"Appointment 0, and 3, 6, 9 and 12 months after appointment 0"},{"outcome_type":"secondary","measure":"Progression of the SOBQ (Shortness of Breath Questionnaire)","time_frame":"Appointment 0, and 3, 6, 9 and 12 months after appointment 0"},{"outcome_type":"secondary","measure":"Proportion of the Participants With Exacerbations","time_frame":"Appointment 0, and 3, 6, 9 and 12 months after appointment 0"},{"outcome_type":"secondary","measure":"Cases Of Death (All, Idiopathic Pulmonary Fibrosis Associated)","time_frame":"Up to 12 months"},{"outcome_type":"secondary","measure":"Proportion of the Participants, who After the 3 Week Titration Phase Receive the Full Maintenance Dosage Of Pirfenidone","time_frame":"3, 6, 9 and 12 months after appointment 0"},{"outcome_type":"secondary","measure":"Dosage of Pirfenidone","time_frame":"Up to 12 months"},{"outcome_type":"secondary","measure":"Proportion of the Participants who Change the Dosage Of Pirfenidone","time_frame":"Up to 12 months"},{"outcome_type":"secondary","measure":"Reasons for the Dosage Change","time_frame":"Up to 12 months"},{"outcome_type":"secondary","measure":"Reasons for the Beginning, Change or Discontinuation of a Treatment of Comorbidities of Pirfenidone Associated Adverse Drug Reactions","time_frame":"Up to 12 months"},{"outcome_type":"secondary","measure":"Number of Participants With at Least one Adverse Drug Reaction Under the Therapy With Pirfenidone","time_frame":"Up to 12 months"}]}
{"nct_id":"NCT02172066","start_date":"2014-06-30","phase":"N/A","enrollment":51,"brief_title":"Narrative Exposure Therapy (NET) for Victims of the Recent Flood Disaster in Burundi","official_title":"Evaluation of the Narrative Exposure Therapy (NET) as Means to Reduce Psychological Impairment in the Aftermath of the Recent Flood Disaster in Bujumbura, Burundi","primary_completion_date":"2015-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-05-31","last_update":"2015-07-20","description":"In the aftermath of natural disasters, e.g., flood disasters, there is a great need for humanitarian assistance in the domain of psychological support. This is particularly true in post-conflict settings because people have suffered severely from multiple traumatic events and situations during their lives. The Narrative Exposure Therapy (NET) is a short-term, culturally sensitive treatment approach that aims to reduce Posttraumatic Stress Disorder (PTSD) symptoms. The investigators want to provide evidence, that NET is an effective and efficient module to assist people in the aftermath of natural disasters using the example of the recent flood disaster in Burundi. In addition the investigators aim to explore, how traumatic incidences and maltreatment during childhood may influence treatment outcomes.","other_id":"UKCR2014","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Individuals severely affected (e.g., who had lost their children) by the flood\r\n             disaster in Bujumbura\r\n\r\n          -  All participants were part of the emergency program of the Red Cross Burundi who\r\n             assisted those most affected by the flood disaster in Bujumbura\r\n\r\n          -  Inclusion criteria for therapy: High degree of symptoms of posttraumatic stress\r\n             disorder according to the Posttraumatic Symptom Scale - Interview (PSSI)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnancy\r\n\r\n          -  Current substance dependence\r\n\r\n          -  Psychotic symptoms\r\n      ","sponsor":"University of Konstanz","sponsor_type":"Other","conditions":"Posttraumatic Stress Disorder","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Narrative Exposure Therapy (NET)"}],"outcomes":[{"outcome_type":"primary","measure":"Change from baseline in Diagnosis and load of PTSD symptoms assessed via the Posttraumatic Symptom Scale - Interview (PSS-I) at 3 and 9 months follow-up","time_frame":"baseline, 3-months-follow-up, 9-months-follow-up"},{"outcome_type":"secondary","measure":"Change from baseline in load of depressive symptoms assessed via the Patient Health Questionnaire-9 (PHQ-9) at 3 months and 9 months follow-up","time_frame":"baseline, 3-months-follow-up, 9-months-follow-up"},{"outcome_type":"secondary","measure":"Change in strength of suicidal ideation measured via the Mini International Neuropsychiatric Interview (M.I.N.I.) at 3 months and 6 months follow-up","time_frame":"baseline, 3-months-follow-up, 9-months-follow-up"},{"outcome_type":"other","measure":"Previous traumatic events measured via vivo Event Checklist for War, Detention and Torture Experiences","time_frame":"baseline"},{"outcome_type":"other","measure":"Adverse experiences during childhood measured via the Domestic and Community Violence Checklist","time_frame":"3-months-follow-up"}]}
{"nct_id":"NCT01566552","start_date":"2014-06-30","phase":"Phase 4","enrollment":1300,"brief_title":"Single Dose Liposomal Amphotericin B for Visceral Leishmaniasis","official_title":"Point of Care Diagnosis and Treatment With Single Dose Liposomal Amphotericin B for Visceral Leishmaniasis in India.","primary_completion_date":"2016-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2017-12-31","last_update":"2014-01-22","description":"The study is designed to determine the use of delivering point of care, rapid diagnosis with rK39 and treatment with AmBisome single dose of 10 mg/kg when administrated in the Primary Health Center (PHC) settings with regard to operational feasibility, safety and final cure rate at 6 months after end of treatment. Point of care diagnosis and treatment (PCDT) at the PHC level would bring the best available interventions closer to the patients with visceral leishmaniasis (VL) whose villages are within several kilometers of the PHC. This would support the VL elimination program in the Indian subcontinent.","other_id":"BHU001/2012","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":5,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Male or female patients  5 years of age\r\n\r\n          2. History of fever for more than 2 weeks\r\n\r\n          3. Splenomegaly\r\n\r\n          4. rK 39 rapid test positive\r\n\r\n          5. Biochemical and hematological test values as follows:\r\n\r\n               -  Hemoglobin  5 g/dl\r\n\r\n               -  White blood cell count 1.0 x 109/L\r\n\r\n               -  AST, ALT  3 times the upper limit of normal\r\n\r\n               -  Serum creatinine level within normal limit\r\n\r\n          6. Written informed consent from the patient/ or parent or guardian if under 18 years\r\n             old.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. A history of intercurrent or presence of clinical signs / symptoms of concurrent\r\n             diseases / conditions (e.g. Chronic alcohol consumption or drug addiction, renal,\r\n             hepatic, cardiovascular or CNS disease; diabetes mellitus, dehydration, other\r\n             infectious diseases or major psychiatric diseases) only if the intercurrent conditions\r\n             are not under control before starting the treatment with AmBisome.\r\n\r\n          2. Any condition which according to the investigator might prevent the patient from\r\n             completing the study therapy and subsequent follow up\r\n\r\n          3. A history of allergy or hypersensitivity to Amphotericin B\r\n\r\n          4. Previous treatment for VL\r\n\r\n          5. Prior treatment failure with Amphotericin B\r\n\r\n          6. Post Kala-azar Dermal Leishmaniasis (PKDL\r\n      ","sponsor":"Banaras Hindu University","sponsor_type":"Other","conditions":"Visceral Leishmaniasis","interventions":[{"intervention_type":"Drug","name":"Drug: AMBISOME","description":"SINGLE DOSE AMBISOME FOR TREATMENT OF VISCERAL LEISHMANIASIS"}],"outcomes":[{"outcome_type":"primary","measure":"CLINICAL CURE","time_frame":"24 MONTHS"}]}
{"nct_id":"NCT02050542","start_date":"2014-06-30","phase":"N/A","enrollment":108,"brief_title":"Study of Current Practice Which Compare the Rate of Prostate Cancer by Using 2 Kind of Transrectal Biopsies: 3 by IRM-echography Image Fusion and 12 Systematized Guided Echographies.","official_title":"Comparison of Prostate Cancer Detection Rates Obtained With Multiparametric MRI Targeted Transrectal Ultrasound Biopsies and Systematic Transrectal Ultrasound Biopsies.","primary_completion_date":"2015-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-02-28","last_update":"2018-03-15","description":"The purpose of the study is to show that 3 targeted biopsies on the suspicious image detected by IRM, guided by a fusion of MRI and ultrasound- images with the Koelis  system, will get no lower rate of cancer detection than those obtained by 12 systematic transrectal ultrasound-guided biopsies of the prostate.","other_id":"2013-A00514-41","allocation":"Non-Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Health Services Research","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":45,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  patient from 45 to 75 years old;\r\n\r\n          -  Serum level of PSA > 4,0 ng / mL;\r\n\r\n          -  Multiparametric prostate IRM, performed before inclusion and which confirm the\r\n             diagnosis of suspected target;\r\n\r\n          -  No opposition of the patient notified in the medical record\r\n\r\n          -  patient member in a national insurance scheme.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Previous prostate biopsy;\r\n\r\n          -  suspicious digital rectal examination;\r\n\r\n          -  serum PSA > 20,0 ng / mL;\r\n\r\n          -  treatment with 5 alpha reductase inhibitor during the last 3 months;\r\n\r\n          -  untreated urinary infection\r\n      ","sponsor":"Assistance Publique - Hpitaux de Paris","sponsor_type":"Other","conditions":"Prostate Cancer","interventions":[{"intervention_type":"Procedure","name":"Procedure: systematic biopsies","description":"90 patients will have to undergo 12 systematic transrectal ultrasound-guided biopsies of the prostate"},{"intervention_type":"Procedure","name":"Procedure: Targeted biopsies guided by a fusion of MRI and ultrasound- images","description":"Immediately after the 12 systematic biopsies, the same patients will have to undergo 3 additional targeted biopsies on the suspicious image detected by IRM, guided by a fusion of MRI and ultrasound- images with the Koelis  system"}],"outcomes":[{"outcome_type":"primary","measure":"Carcinomatous invasion on biopsies samples","time_frame":"Day 15","description":"The presence of carcinomatous invasion on biopsies samples"},{"outcome_type":"secondary","measure":"Tissue length of biopsy invaded by the detected cancer","time_frame":"Day 15","description":"Maximal tissue length of biopsy invaded by the detected cancer"},{"outcome_type":"secondary","measure":"Biopsy Gleason score of the detected cancer","time_frame":"Day 15","description":"Maximal biopsy Gleason score of the detected cancer"},{"outcome_type":"secondary","measure":"Respective duration of each biopsy protocol","time_frame":"Day 0"}]}
{"nct_id":"NCT02188069","start_date":"2014-06-30","enrollment":750,"brief_title":"Canadian SCAD Study","official_title":"Canadian Spontaneous Coronary Artery Dissection (SCAD) Cohort Study","primary_completion_date":"2020-06-30","study_type":"Observational [Patient Registry]","rec_status":"Unknown status","completion_date":"2020-12-31","last_update":"2018-08-10","description":"SCAD (Spontaneous coronary artery dissection - tear in the arterial wall that is not related to trauma) is an under-diagnosed and poorly understood condition that mostly affects young women without common cardiovascular risk factors, and can result in heart attack and death. This observational study is designed to capture the disease's natural history and predisposing arteriopathies (medical conditions resulting in changes in the arteries), treatment strategies, long-term cardiovascular outcomes. It will also improve the diagnosis of SCAD on coronary angiography by participating clinicians, and provide guidance on investigating predisposing conditions.","other_id":"H14-00968","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","population":"Prospective patients presenting with Spontaneous coronary artery dissection (SCAD)","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patients admitted with troponin-positive ACS (NSTEMI or STEMI)\r\n\r\n          2. Documented NA-SCAD on coronary angiogram (including diagnosis with OCT or IVUS)\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients with troponin-negative ACS\r\n\r\n          2. Patients with typical atherosclerotic coronary artery disease in other coronary\r\n             arterial segments with diameter stenosis 50%\r\n      ","sponsor":"Cardiology Research UBC","sponsor_type":"Other","conditions":"Spontaneous Coronary Artery Dissection","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Composite in-hospital outcome","time_frame":"During index admission","description":"Composite of all-cause mortality, stroke, reinfarction (31), cardiogenic shock (requiring medical or mechanical hemodynamic support), congestive heart failure, severe ventricular arrhythmia (requiring defibrillation or antiarrhythmic agents), repeat revascularization (or unplanned revascularization), and cardiac transplantation, collectively termed in-hospital major adverse events (MAE)"},{"outcome_type":"primary","measure":"Composite follow-up outcome","time_frame":"3 years post index event","description":"Composite of all-cause mortality, stroke, recurrent MI (including recurrent dissection), congestive heart failure and repeat revascularization, collectively termed major adverse cardiac events (MACE)."}]}
{"nct_id":"NCT03293810","start_date":"2014-06-27","enrollment":16,"brief_title":"Glybera Registry, Lipoprotein Lipase Deficient (LPLD) Patients","official_title":"Glybera Registry, Long-term Safety and Efficacy Follow-up in Lipoprotein Lipase Deficient (LPLD) Patients Treated With Alipogene Tiparvovec (GLYBERA)","primary_completion_date":"2033-09-30","study_type":"Observational [Patient Registry]","rec_status":"Active, not recruiting","completion_date":"2033-10-31","last_update":"2021-04-15","description":"Lipoprotein lipase deficiency (LPLD) is a rare autosomal recessive disorder, characterized by loss-of function mutations in the LPL gene, leading to the inability to produce functionally active lipoprotein lipase (LPL). LPL is the key enzyme in the metabolism of triglyceride (TG)-rich lipoproteins (chylomicrons (CM) and very low-density lipoproteins (VLDL)). LPLD results in extremely high concentrations of circulating TG-rich lipoproteins. No drug therapy for LPLD is currently available. Clinical management of LPLD patients consists of severe dietary fat restriction and the use of medium-chain triglycerides to substitute for normal dietary fats. Alipogene tiparvovec (Glybera) received marketing authorisation from the European commission on 25 October 2012. Glybera aims to correct lipoprotein lipase deficiency sufficiently to decrease the morbidity and lower the risk of inherent complications of LPLD, in adult patients genetically diagnosed with LPLD. The Glybera Registry is designed to collect the long-term safety and efficacy data of GLYBERA","other_id":"REG-uQ-Glyb-001","observational_model":"Other","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","population":"Patients treated with GLYBERA, either during their participation in a clinical trial or in\r\n        the commercial setting till October 25th, 2017","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  All patients treated with GLYBERA, either during their participation in a clinical\r\n             trial or in the commercial setting till October 25th, 2017 (= expiration date of\r\n             Marketing Authorization of GLYBERA), and\r\n\r\n          -  Who are currently participating in the LPLD Registry\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  None\r\n      ","sponsor":"UniQure Biopharma B.V.","sponsor_type":"Industry","conditions":"Lipoprotein Lipase Deficiency|Familial Hyperlipoproteinemia Type 1|Familial Hyperchylomicronemia","interventions":[{"intervention_type":"Other","name":"Other: Observational study","description":"Post-Authorization Safety Study"}],"outcomes":[{"outcome_type":"primary","measure":"Long-term collection of Safety and Efficacy of GLYBERA®, as measured by collection of Adverse Events, Immunological responses and information on Pancreatitis-events","time_frame":"15 years","description":"Adverse Events will be collected as reported by the patients during routine visits/contacts.\r\nImmunological responses defined as antibody formation and T-cell responses against the AAV1-capsid and against the LPLS447X transgene product, measured just before dosing and at 6 and 12 months post-dosing.\r\nPancreatitis-events will be collected as reported by the patients during routine visits/contacts"}]}
{"nct_id":"NCT02371720","start_date":"2014-06-01","phase":"N/A","enrollment":164,"brief_title":"Patient Centered Comprehensive Medication Adherence Management System in Patients With Sickle Cell Disease","official_title":"Patient Centered Comprehensive Medication Adherence Management System to Improve Effectiveness of Disease Modifying Therapy With Hydroxyurea in Patients With Sickle Cell Disease","primary_completion_date":"2018-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-12-31","last_update":"2021-03-05","description":"The purpose of this research study is to learn about ways to help children and adults with sickle cell disease who are taking the medication, hydroxyurea.","other_id":"IRB00074105","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":2,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  be >2 years of age up to 65 years of age, inclusive\r\n\r\n          -  have a diagnosis of SCD, with either S/S, S/C, S/D, S/0, S/O-Arab, or S/+\r\n             genotype\r\n\r\n          -  prescribed Hydroxyurea for at least the 6 months prior to study entry\r\n\r\n          -  have daily access to a smart phone, tablet, personal computer or other device capable\r\n             of producing and transmitting videos over the internet\r\n\r\n          -  be willing and able to record and transmit videos\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  patient or caregiver refuses to take Hydroxyurea as treatment for SCD\r\n\r\n          -  diagnosis of significant psychiatric disorder of the subject that could seriously\r\n             impede the ability to participate in the study\r\n\r\n          -  an assessment by the investigator that the subject will not comply with the study\r\n             procedures outlined in the study protocol\r\n\r\n          -  patients receiving automatic home delivery of medications since medication possession\r\n             ratio is reflective of the patient initiation the refill when they have exhausted the\r\n             home supply of HU\r\n      ","sponsor":"Emory University","sponsor_type":"Other","conditions":"Sickle Cell Disease","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Mobile DOT","description":"Daily reminders via text or email to send a video of themselves taking their Hydroxyurea, positive feedback, and be encouraged to contact the research coordinator with any questions, concerns, etc."}],"outcomes":[{"outcome_type":"primary","measure":"Medication Possession Ratio (MPR)","time_frame":"12 months","description":"Proportion of days the patient is in possession of the medication in the study period"},{"outcome_type":"secondary","measure":"Change in Hemoglobin (Hb) levels","time_frame":"Baseline, 24 months","description":"Change in hemoglobin levels from baseline to 24 months will be measured using the HemoCue® rapid test."},{"outcome_type":"secondary","measure":"Change in mean cell volume (MCV)","time_frame":"Baseline, 24 months","description":"Change from baseline in MCV will be calculated as the value at 24 months minus the value at baseline. MCV is the average size of the red blood cells expressed in femtoliters. MCV is calculated by dividing the hematocrit (as percent) by the red blood cell (RBC) count in millions per microliter of blood, then multiplying by 10."},{"outcome_type":"secondary","measure":"Change in fetal hemoglobin (HbF) levels","time_frame":"Baseline, 24 months","description":"Change from baseline in HbF will be calculated as the value at 24 months minus the value at baseline. HbF is expressed as a percentage."},{"outcome_type":"secondary","measure":"Impact of adherence on clinical outcomes and healthcare utilization","time_frame":"Baseline, 24 months","description":"Health care utilization in the emergency department and hospitalization due to sickle cell related complications such as vaso-occlusive crisis (VOC) or acute chest syndrome (ACS). Retrospective chart review at baseline will be conducted to determine healthcare utilization."},{"outcome_type":"secondary","measure":"Impact of adherence on patients' lives","time_frame":"Baseline, 24 months","description":"Impact of adherence on patients' lives measured using patient reported outcomes (PROMIS), surveys of school attendance, work absenteeism, out-of-pocket costs incurred by patients and their caregivers"},{"outcome_type":"secondary","measure":"Change in adherence with using Mobile-DOT","time_frame":"Baseline, 24 months","description":"Retrospective chart review at baseline will be conducted to determine medication possession rate (MPR) and then compared to the MPR at 24 months."},{"outcome_type":"secondary","measure":"Acceptability of intervention and of Hydroxyurea","time_frame":"Baseline, 24 months","description":"Acceptability will be measured by Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) The TSQM is a 14-item subject-assessed evaluation of treatment medication including 4 factors, Effectiveness, Side Effects, Convenience, and Global Satisfaction, and it utilizes the following responses on a 7-point Likert scale: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Scores range from 0-100, with 0 as extremely dissatisfied and 100 as extremely satisfied."}]}
{"nct_id":"NCT02569021","start_date":"2014-05-31","enrollment":30,"brief_title":"Battery-preserving Stimulation Patterns for Deep Brain Stimulation","official_title":"Battery-preserving Stimulation Patterns to Improve Symptoms in Parkinson's Disease and Essential Tremor","primary_completion_date":"2016-04-30","study_type":"Observational","rec_status":"Completed","completion_date":"2016-09-30","last_update":"2016-10-24","description":"The purpose of this research study is to test effectiveness of different deep brain stimulation (DBS) stimulation patterns on symptoms that may also improve the life of the battery. If these patterns are effective, the implanted batteries will be drained more slowly and last longer than currently expected. An increase in battery life may reduce the number of surgeries needed to replace them.","other_id":"IRB201501030","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients will be recruited during routine DBS programming sessions at the University of\r\n        Florida, Center for Movement Disorders","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosis of Parkinson's disease or Essential Tremor by strict criteria\r\n\r\n          -  Deep brain stimulation (DBS) already implanted\r\n\r\n          -  Optimized Deep brain stimulation (DBS) settings (or at least 4 months of DBS\r\n             programming)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Other neurological diagnoses (co-existent Alzheimer's or ALS)\r\n\r\n          -  No Deep brain stimulation (DBS)\r\n\r\n          -  less than 4 Deep brain stimulation (DBS) programming\r\n      ","sponsor":"University of Florida","sponsor_type":"Other","conditions":"Parkinsons Disease|Essential Tremor","interventions":[{"intervention_type":"Other","name":"Other: Unified Parkinson's Disease Rating Scale","description":"UPDRS is used by neurologists to rate the motor impairment of people with Parkinson's Disease."},{"intervention_type":"Other","name":"Other: Tremor Rating Scale","description":"TRS is used by neurologists to rate the severity of a tremor."},{"intervention_type":"Device","name":"Device: Biphasic DBS stimulation","description":"The following protocol will be followed for each subject. In between, baseline and novel stimulation settings there will be a 30-minute washout period with DBS in the off state.\r\nCurrent best/optimized DBS setting (considered \"baseline\")\r\nDBS off for 30 minutes as a washout period\r\nBiphasic pulse stimulation mode (assessment at 0.5hr)\r\nBiphasic pulse stimulation mode (assessment at 1hr)\r\nBiphasic pulse stimulation mode (assessment at 2hr)\r\nBiphasic pulse stimulation mode (assessment at 3hr)"},{"intervention_type":"Device","name":"Device: Kinesia accelerometer","description":"The kinesia accelerometer is used to analyze the tremor and slowness (bradykinesia) of the participants."},{"intervention_type":"Device","name":"Device: Trigno wireless system","description":"The Trigno system measure muscle contractions."},{"intervention_type":"Other","name":"Other: GaitRite walking assessment.","description":"GaitRite records a patients gait pattern."}],"outcomes":[{"outcome_type":"primary","measure":"Evaluate the efficacy of novel stimulation patterns by the Unified Parkinson's Disease Rating Scale","time_frame":"Baseline to Day 1","description":"The Unified Parkinson's Disease Rating Scale (UPDRS) is used by neurologists to rate the motor impairment of people with Parkinson's Disease. The rater obtains the score by observation and questioning the participant. Higher scores represent greater impairment and scores range from 0-108. The subject will be videotaped and two raters blinded to conditions will score the UPDRS."},{"outcome_type":"primary","measure":"Evaluate the efficacy of novel stimulation patterns by the Tremor Rating Scale","time_frame":"Baseline to Day 1","description":"Tremor Rating Scale (TRS), consists of 11 items that evaluate tremor in the head, arms, and legs. The rater assigns a score of 0 to 4 for each item, in ascending order of severity. The subjet will be videotaped and two raters blinded to conditions will score the TRS."},{"outcome_type":"primary","measure":"Kinesia accelerometer to measure motor dysfunction","time_frame":"Baseline to Day 1","description":"The Kinesia system includes a unit worn by the subject and software that is used to collect, manage, and analyze data. The system measures three-dimensional motion using three orthogonal accelerometers and three orthogonal gyroscopes located in the sensor module.The digital data is received by the Receiver connected to a computer and processed by the Kinesia software package."},{"outcome_type":"primary","measure":"Trigno wireless system to measure motor dysfunction","time_frame":"Baseline to Day 1","description":"This system has sensors with a multi-function design and therefore along with recording of surface EMG signal, it allows Triaxial Accelerometry. This wireless EMG machine will measure muscle contractions."},{"outcome_type":"primary","measure":"GaitRite walking assessment.","time_frame":"Baseline to Day 1","description":"The GaitRite is an automated floor that when the subjects walk on the floor it records the gait pattern."},{"outcome_type":"secondary","measure":"Battery Consumption compared between pre and post settings","time_frame":"Baseline to Day 1","description":"Battery consumption will be calculated and compared between the new settings and subjects' baseline settings. The Medtronic battery estimator helpline will be used to calculate battery life, as well as the University of Florida calculator."}]}
{"nct_id":"NCT02129101","start_date":"2014-05-31","phase":"Phase 1","enrollment":63,"brief_title":"Azacitidine and Sonidegib or Decitabine in Treating Patients With Myeloid Malignancies","official_title":"Phase I/Ib Study of Azacitidine or Decitabine With Hedgehog Pathway Inhibition in Myeloid Malignancies","primary_completion_date":"2016-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-10-25","last_update":"2019-10-30","description":"This phase I/Ib trial studies the side effects and best dose of azacitidine and sonidegib or decitabine and so see how well they work in treating patients with myeloid malignancies. The hedgehog (Hh) signaling pathway plays an important role in cellular growth, differentiation and repair. Inappropriate activation of Hh pathway signaling and uncontrolled cellular proliferation may be associated with mutations in the Hh-ligand cell surface receptor Smo. Sonidegib binds to the Hh cell surface receptor Smo, which may result in the suppression of the Hh signaling pathway and the inhibition of cancer cells. Azacitidine and decitabine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving azacitidine together with sonidegib or decitabine may be a safe and successful treatment for patients with myeloid malignancies.","other_id":"MC1389","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with one of the following diagnoses:\r\n\r\n               -  Intermediate, high and very high risk (per International Prognostic Scoring\r\n                  System [IPSS]-revised [R]) untreated MDS or any MDS with >= 5% marrow blasts (by\r\n                  French American British [FAB] and World Health Organization [WHO] diagnostic\r\n                  criteria); NOTE: MDS/MPN overlap is allowed\r\n\r\n               -  CMML requiring treatment per doctor of medicine (MD) judgment\r\n\r\n               -  Low and very low risk MDS patients symptomatic and/or transfusion dependent, (>=\r\n                  4 U red blood cells [RBC] over the preceding 12 week period) who have failed\r\n                  erythropoietin-stimulating agents (ESAs) or who have a low likelihood of\r\n                  responding to ESAs\r\n\r\n               -  MDS and CMML patients relapsed/refractory to hypomethylating agents as evidenced\r\n                  by one of the following:\r\n\r\n                    -  Progressed at any time during treatment with hypomethylating agents\r\n\r\n                    -  Failed to achieve a response after 6 cycles of 5-azacytidine or 4 cycles of\r\n                       decitabine\r\n\r\n                    -  Progressed after treatment with hypomethylating agents had been discontinued\r\n\r\n                         -  NOTE: MDS/MPN overlap is allowed\r\n\r\n               -  Relapsed or refractory AML exposed to =< 3 prior regimens (note, induction and\r\n                  consolidation including stem cell transplantation count as one regimen)\r\n\r\n               -  For exploratory phase I LDE225 days 1-7 with azacitidine or LDE225 days 1-28 with\r\n                  decitabine cohorts only: untreated AML/CMML/MDS/MPN overlap or\r\n                  relapsed/refractory AML/CMML/MDS/MPN overlap WITHOUT prior exposure to a\r\n                  hypomethylating agent (HMA)\r\n\r\n               -  Elderly (age >= 60) untreated AML and not a candidate for induction therapy\r\n\r\n               -  Untreated AML < 60 year of age who are not candidates to undergo standard\r\n                  induction chemotherapy\r\n\r\n               -  Primary myelofibrosis (PMF) and post essential thrombocytopenia (ET)/polycythemia\r\n                  vera (PV) MF with a Dynamic International Prognostic Scoring System (DIPSS)-plus\r\n                  score of intermediate or high, or a > 10% blasts in the marrow and who are in\r\n                  need of therapy and who have failed previous treatment with a janus kinase 2\r\n                  (JAK2) inhibitor and, if appropriate, have failed Interferon based treatment\r\n\r\n          -  Total bilirubin =< 1.5 mg/dL (except Gilbert's syndrome or known hemolysis or leukemic\r\n             infiltration)\r\n\r\n          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and\r\n             alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x\r\n             upper limit of normal (ULN) or < 5 x ULN if organ involvement\r\n\r\n          -  Alkaline phosphatase < 5 x ULN\r\n\r\n          -  Serum creatinine =< 1.5 x ULN or 24 hour creatinine (Cr) clearance > 50 ml/min\r\n\r\n          -  Plasma creatine phosphokinase (CK) < 1.5 x ULN\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2\r\n\r\n          -  Ability to provide informed written consent and be able to adhere to the study visit\r\n             schedule and other protocol requirements\r\n\r\n          -  Willing to return to enrolling institution for follow-up (during the active monitoring\r\n             phase of the study)\r\n\r\n          -  Willing to provide blood and bone marrow aspirate samples for correlative research\r\n             purposes\r\n\r\n          -  Negative serum pregnancy test done =< 7 days prior to registration, for women of\r\n             childbearing potential only\r\n\r\n          -  Men must be willing to use appropriate contraception throughout study and for 6 months\r\n             after; women must be willing to use appropriate contraception throughout study and for\r\n             20 months after\r\n\r\n          -  Patients who have undergone stem cell transplantation (SCT), autologous or allogeneic,\r\n             are eligible provided that they are > 84 days from stem cell infusion, have no active\r\n             graft-versus-host disease (GVHD), are off immunosuppressive agents for > 14 days\r\n\r\n          -  In the opinion of the investigator, patient must be able to receive at least 2 cycles\r\n             of treatment\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Uncontrolled intercurrent illness including, but not limited to, active uncontrolled\r\n             infection, known positive for active infectious hepatitis, type A, B or C; (past\r\n             infection allowed), or psychiatric illness/social situations that would limit\r\n             compliance with study requirements; Note: ongoing infection controlled on\r\n             antibiotics/antifungal/antiviral medications are allowed unless listed as\r\n             contraindicated\r\n\r\n          -  Any of the following prior therapies:\r\n\r\n               -  Cytotoxic chemotherapy =< 14 days prior to registration\r\n\r\n               -  Immunotherapy =< 14 days prior to registration\r\n\r\n               -  Biologic therapy (i.e. antibody therapies) =< 14 days prior to registration\r\n\r\n               -  Radiation therapy =< 14 days prior to registration\r\n\r\n               -  Targeted therapies (i.e. kinase inhibitors, =< 7 days or 5 half-life's whichever\r\n                  is shorter)\r\n\r\n               -  Patients must be off other biologic therapies including hematopoietic growth\r\n                  factors >= 7 days prior to registration\r\n\r\n               -  For steroids or other non-cytotoxics given for blast count control, patient must\r\n                  be off for > 24 hours (hrs) before starting therapy; NOTE: hydroxyurea (HU) is\r\n                  allowed for blast count control throughout study\r\n\r\n               -  Receiving any other investigational agent which would be considered as a\r\n                  treatment for the primary neoplasm =< 14 days prior to registration\r\n\r\n          -  Active uncontrolled central nervous system (CNS) leukemia; NOTE: positive\r\n             (cyto)pathology is allowed and patient can receive intrathecal chemotherapy\r\n\r\n          -  Immunocompromised patients and patients known to be human immunodeficiency virus (HIV)\r\n             positive and currently receiving antiretroviral therapy; NOTE: patients known to be\r\n             HIV positive, but without clinical evidence of an immunocompromised state, are\r\n             eligible for this trial\r\n\r\n          -  Any previous treatment with LDE225 or allergic reactions to excipients of LDE225\r\n\r\n          -  Acute promyelocytic leukemia (APL, M3) unless failed regimens that included tretinoin,\r\n             arsenic trioxide, anthracyclines and cytarabine and currently NOT candidates for stem\r\n             cell transplantation\r\n\r\n          -  Major surgery =< 28 days prior to registration\r\n\r\n          -  Patients who have neuromuscular disorders (e.g. inflammatory myopathies, muscular\r\n             dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy) or are on\r\n             concomitant treatment with drugs that are recognized to cause rhabdomyolysis, such as\r\n             3-hydroxy-3-methylglutaryl-CoA (HMG CoA) inhibitors (statins), clofibrate and\r\n             gemfibrozil, and that cannot be discontinued at least 5 half lives prior to starting\r\n             LDE225 treatment; NOTE: if it is essential that the patient stays on a statin to\r\n             control hyperlipidemia, only pravastatin may be used with extra caution\r\n\r\n          -  Patients who are planning on embarking on a new strenuous exercise regimen after\r\n             initiation of study treatment; NOTE: muscular activities, such as strenuous exercise,\r\n             that can result in significant increases in plasma creatine kinase (CK) levels should\r\n             be avoided whilst on LDE225 treatment\r\n\r\n          -  Patients who are receiving treatment with medications known to be moderate and strong\r\n             inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4\r\n             (CYP3A4)/cytochrome P450, family 3, subfamily A, polypeptide 5 (5) or drugs\r\n             metabolized by cytochrome P450, family 2, subfamily B, polypeptide 6 (CYP2B6) or\r\n             cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9) that have narrow\r\n             therapeutic index, and that cannot be discontinued before starting treatment with\r\n             LDE225; medications that are strong CYP3A4/5 inhibitors should be discontinued at\r\n             least 7 days and strong CYP3A4/5 inducers for at least 2 weeks prior to starting\r\n             treatment with LDE225; NOTE: patients who are already on or require initiation of\r\n             azoles other than fluconazole will be excluded from the phase I dose escalation\r\n             portion of the study\r\n\r\n          -  Impaired cardiac function or clinically significant heart disease, including any one\r\n             of the following:\r\n\r\n               -  Angina pectoris within 3 months\r\n\r\n               -  Acute myocardial infarction within 3 months\r\n\r\n               -  Corrected Fridericia's QT (QTcF) > 450 msec for males and > 470 msec for females\r\n                  on the screening electrocardiogram (ECG)\r\n\r\n               -  A past medical history of clinically significant ECG abnormalities or a family\r\n                  history of prolonged QT-interval syndrome\r\n\r\n               -  New York Heart Association classification IV cardiovascular disease or\r\n                  symptomatic class III disease\r\n\r\n               -  Other clinically significant heart disease (e.g. congestive heart failure,\r\n                  uncontrolled hypertension, history of labile hypertension, or history of poor\r\n                  compliance with an antihypertensive regimen)\r\n\r\n          -  Any of the following:\r\n\r\n               -  Pregnant women\r\n\r\n               -  Nursing women\r\n\r\n               -  Men or women of childbearing potential who are unwilling to employ adequate\r\n                  contraception during the study and through 20 months after the final dose of\r\n                  study treatment if female, and for 6 months after final dose of study treatment\r\n                  if male\r\n\r\n               -  NOTE: adequate contraception is defined as either:\r\n\r\n                    -  Total abstinence: when this is in line with the preferred and usual\r\n                       lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation,\r\n                       symptothermal, post-ovulation methods) and withdrawal are not acceptable\r\n                       methods of contraception\r\n\r\n                    -  Sterilization: patient has had surgical bilateral oophorectomy (with or\r\n                       without hysterectomy) or tubal ligation at least six weeks before taking\r\n                       study treatment; in case of oophorectomy alone, only when the reproductive\r\n                       status of the woman has been confirmed by follow up hormone level assessment\r\n\r\n                    -  Male partner sterilization (with the appropriate post-vasectomy\r\n                       documentation of the absence of sperm in the ejaculate); (for female study\r\n                       patients, the vasectomized male partner should be the sole partner for that\r\n                       patient)\r\n\r\n                    -  Use a combination of the following:\r\n\r\n                         -  Placement of a non-hormonal intrauterine device (IUD) or non-hormonal\r\n                            intrauterine system (IUS)\r\n\r\n                         -  Barrier method of contraception: condom or occlusive cap (diaphragm or\r\n                            cervical vault caps) with spermicidal foam/gel/film/cream/vaginal\r\n                            suppository\r\n\r\n                              -  Note: hormonal contraception methods (e.g. oral, injected,\r\n                                 implanted) are not allowed as it cannot be ruled out that the\r\n                                 study drug decreases the effectiveness of hormonal contraception\r\n\r\n                              -  Note: women are considered post-menopausal and not child bearing\r\n                                 potential if they have had 12 months of natural (spontaneous)\r\n                                 amenorrhea with an appropriate clinical profile (e.g. age\r\n                                 appropriate, history of vasomotor symptoms) or six months of\r\n                                 spontaneous amenorrhea with serum follicle stimulating hormone\r\n                                 (FSH) levels > 40 mIU/mL and estradiol < 20 pg/mL or have had\r\n                                 surgical bilateral oophorectomy (with or without hysterectomy) at\r\n                                 least six weeks ago; in the case of oophorectomy alone, only when\r\n                                 the reproductive status of the woman has been confirmed by follow\r\n                                 up hormone level assessment is she considered not of child bearing\r\n                                 potential\r\n\r\n                              -  Note: male patient must use highly effective (double barrier)\r\n                                 methods of contraception (e.g., spermicidal gel plus condom) for\r\n                                 the entire duration of the study, and continuing using\r\n                                 contraception and refrain from fathering a child for 6 months\r\n                                 following the study drug; a condom is required to be used also by\r\n                                 vasectomized men as well as during intercourse with a male partner\r\n                                 in order to prevent delivery of the study treatment via seminal\r\n                                 fluid\r\n      ","sponsor":"Mayo Clinic","sponsor_type":"Other","conditions":"Chronic Myelomonocytic Leukemia|de Novo Myelodysplastic Syndrome|Essential Thrombocythemia|Myelodysplastic Syndrome|Myelodysplastic/Myeloproliferative Neoplasm|Polycythemia Vera|Previously Treated Myelodysplastic Syndrome|Primary Myelofibrosis|Recurrent Adult Acute Myeloid Leukemia|Recurrent Childhood Acute Myeloid Leukemia|Untreated Adult Acute Myeloid Leukemia","interventions":[{"intervention_type":"Drug","name":"Drug: Azacitidine","description":"Given SC or IV"},{"intervention_type":"Drug","name":"Drug: Decitabine","description":"Given IV"},{"intervention_type":"Other","name":"Other: Laboratory Biomarker Analysis","description":"Correlative studies"},{"intervention_type":"Other","name":"Other: Quality-of-Life Assessment","description":"Ancillary studies"},{"intervention_type":"Drug","name":"Drug: Sonidegib","description":"Given PO"}],"outcomes":[{"outcome_type":"primary","measure":"Best overall response (complete response [CR] or complete response with incomplete recovery [CRi]) in untreated AML, CMML, MDS, or MDS/MPN Overlap patients (Phase IB [Dose Expansion])","time_frame":"Up to 30 days post-treatment","description":"The proportion of CR/CRi responses will be estimated (by cohort) by the number of CR/CRi responses divided by the total number of evaluable patients. 95% exact binomial confidence intervals will be computed. The frequency and relative frequency of individual response categories will also be computed. Best overall response over all cycles of study treatment will also be described using frequency and relative frequency of individual response categories."},{"outcome_type":"primary","measure":"Best overall response (CR or CRi) in myelofibrosis patients (Phase IB [Dose Expansion])","time_frame":"Up to 30 days post-treatment","description":"The proportion of CR/CRi responses will be estimated (by cohort) by the number of CR/CRi responses divided by the total number of evaluable patients. 95% exact binomial confidence intervals will be computed. The frequency and relative frequency of individual response categories will also be computed. Best overall response over all cycles of study treatment will also be described using frequency and relative frequency of individual response categories."},{"outcome_type":"primary","measure":"Best overall response (CR or CRi) in relapsed/refractory AML, CMML, MDS, or MDS/MPN Overlap patients (Phase IB [Dose Expansion])","time_frame":"Up to 30 days post-treatment","description":"The proportion of CR/CRi responses will be estimated (by cohort) by the number of CR/CRi responses divided by the total number of evaluable patients. 95% exact binomial confidence intervals will be computed. The frequency and relative frequency of individual response categories will also be computed. Best overall response over all cycles of study treatment will also be described using frequency and relative frequency of individual response categories."},{"outcome_type":"primary","measure":"MTD defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients) (Phase I)","time_frame":"42 days","description":"Graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0."},{"outcome_type":"secondary","measure":"Duration of response","time_frame":"Date at which the patient's earliest best objective status is first noted to be a CR/CRi response to the earliest date progression is documented, assessed up to 30 days post-treatment","description":"The distribution of duration of response will be estimated using the method of Kaplan-Meier."},{"outcome_type":"secondary","measure":"Incidence of adverse events graded using the NCI CTCAE version 4.0 (Phase IB [dose expansion])","time_frame":"Up to 30 days post-treatment","description":"The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns (by cohort and overall). Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. The rate of grade 3 or higher non-hematologic adverse events, and the rate of grade 4 or higher adverse event (hematologic and non-hematologic) will be computed each with a 95% exact binomial confidence interval."},{"outcome_type":"secondary","measure":"Overall survival","time_frame":"Time from registration to death due to any cause, assessed up to 30 days post-treatment","description":"The distribution of survival time will be estimated using the method of Kaplan-Meier."},{"outcome_type":"secondary","measure":"Time to AML","time_frame":"Time from registration to leukemic transformation due to any cause, assessed up to 30 days post-treatment","description":"The distribution of time to AML will be estimated using the method of Kaplan-Meier."},{"outcome_type":"secondary","measure":"Time to death","time_frame":"Time from registration to death due to any cause, assessed up to 30 days post-treatment","description":"The distribution of time to death will be estimated using the method of Kaplan-Meier."},{"outcome_type":"secondary","measure":"Time to progression","time_frame":"Time from registration to the earliest date of documentation of disease progression, assessed up to 30 days post-treatment","description":"The distribution of time to progression will be estimated using the method of Kaplan-Meier."},{"outcome_type":"other","measure":"Biomarker levels","time_frame":"Up to 30 days post-treatment","description":"Statistical analysis of each biomarker will be primarily descriptive. Continuous biomarker levels will be explored in a graphical manner including mean plots and plots of change and percent change from baseline and other summary measures. Any potential relationships between the baseline level or change in the level of each biomarker and clinical outcome such as overall response, 6-month progression and survival, and adverse event incidence will be further analyzed using Wilcoxon rank sum tests or logistic regression methods, as appropriate."},{"outcome_type":"other","measure":"Patient-reported outcomes (quality of life and symptoms) as assessed by the EORTC QLQ-C30 and MPN-SAF Total Symptom Score (TSS)","time_frame":"Up to 30 days post-treatment","description":"Scale score trajectories over time will be examined using stream plots and mean plots with standard deviation error bars overall. Changes from baseline at each cycle will be statistically tested using paired t-tests, and standardized response means (mean of the change from baseline scores at a given cycle, divided by the standard deviation of the change scores) will be interpreted (after applying Middel's adjustment) using Cohen's cut-offs."}]}
{"nct_id":"NCT01925573","start_date":"2014-05-31","phase":"N/A","enrollment":7,"brief_title":"Optune(NOVOTTF-100A)+ Bevacizumab+ Hypofractionated Stereotactic Irradiation Bevacizumab-Naive Recurrent Glioblastoma (GCC 1344)","official_title":"Proposed Pilot Study of Combined Optune+ Bevacizumab, and Hypofractionated Stereotactic Irradiation for Bevacizumab-Naive Recurrent Glioblastoma","primary_completion_date":"2019-08-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2019-08-31","last_update":"2020-11-04","description":"This protocol is designed to generate and provide preliminary data to determine the safety and activity of combination therapy using tumor treating fields (TTFields; Optune(NovoTTF-100A); Novocure, Haifa, Israel), a novel FDA-approved therapy utilizing alternating electric fields to inhibit tumor cell growth, along with bevacizumab (Avastin; Genentech, San Francisco, CA), a humanized monoclonal antibody that inhibits vascular endothelial growth factor (VEGF), and hypofractionated stereotactic radiotherapy, a highly-focal abbreviated course of brain irradiation, in the treatment of patients with bevacizumab-naive recurrent GBM. Each of these individual therapies, and also several combinations in doublets, has already demonstrated safety and efficacy but prospective clinical data for the concurrent combination of all three therapies are lacking.","other_id":"HP-00056719","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":22,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  1 Patients with recurrent or progressive glioblastoma or other grade IV malignant\r\n             glioma (i.e. glioblastoma, gliosarcoma, giant cell glioblastoma, etc.) who have failed\r\n             prior radiation but who have not progressed/recurred on bevacizumab. Patients will be\r\n             eligible if the original histology was lower-grade glioma and subsequent diagnosis of\r\n             glioblastoma or gliosarcoma is made.\r\n\r\n             2 Patients with any number of recurrences are allowed. 3 Brain MRI demonstrates an\r\n             enhancing tumor < 8 cm in largest diameter. 4 Karnofsky performance status  70%. 5\r\n             Age  22 years old. 6 Patients must have the following laboratory values:\r\n\r\n               -  Absolute neutrophil count (ANC)  1.5 x 109/L\r\n\r\n               -  Platelets  100 x 109/L\r\n\r\n               -  Hemoglobin (Hgb) > 10 g/dL\r\n\r\n               -  Serum total bilirubin:  1.5 x ULN\r\n\r\n               -  ALT and AST  3.0 x ULN\r\n\r\n               -  Adequate Renal Function: BUN and Cr < 2.0 x ULN\r\n\r\n               -  Blood coagulation parameters: international normalized ratio (INR)  1.5 for\r\n                  patients not on warfarin 7 Minimum interval since completion of radiation\r\n                  treatment is 12 weeks. 8 History of standard dose CNS radiotherapy: radiation of\r\n                  60 Gy in 30 fractions or 59.4 Gy in 1.8 Gy fractions, or equivalent or lower\r\n                  doses.\r\n\r\n                  9 Minimum interval since last major surgery, open biopsy, or significant\r\n                  traumatic injury is 4 weeks 10 Minimum interval since last drug therapy:\r\n\r\n               -  3 weeks since last non-cytotoxic therapy\r\n\r\n               -  3 weeks must have elapsed since the completion of a non-nitrosourea-containing\r\n                  chemotherapy regimen\r\n\r\n               -  6 weeks since the completion of a nitrosourea-containing chemotherapy regimen. 11\r\n                  Patients must have signed an approved informed consent and authorization\r\n                  permitting release of personal health information.\r\n\r\n                  12 Patients with the potential for pregnancy or impregnating their partner must\r\n                  agree to follow acceptable birth control methods to avoid conception. Female\r\n                  patients of child-bearing potential must have a negative pregnancy test.\r\n\r\n                  13 Patients with history of prior invasive malignancy (except non-melanomatous\r\n                  skin cancer) must have been disease free for a minimum of 1 year.\r\n\r\n                  14 Patients must be maintained on a stable corticosteroid regimen from the time\r\n                  of their baseline scan until the start of treatment and/or for at least 5 days\r\n                  before starting treatment.\r\n\r\n                  15 Patients on full-dose anticoagulants (e.g., warfarin or LMW heparin) must meet\r\n                  both of the following criteria: 16 No active bleeding or pathological condition\r\n                  that carries a high risk of bleeding (e.g., tumor involving major vessels or\r\n                  known varices) 17 In-range INR (max  3) on a stable dose of oral anticoagulant\r\n                  for greater than 1 month or on a stable dose of low molecular weight heparin\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  1 Any prior therapy with bevacizumab 2 Any significant hemorrhage defined as > 1 cm\r\n             diameter of blood seen on the MRI or CT scan. If > 1 cm of acute blood is detected,\r\n             the patient will be ineligible for this trial.\r\n\r\n             3 Patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or\r\n             intra-pelvic), open biopsy or significant traumatic injury  4 weeks prior to starting\r\n             study drug, or patients who have had minor procedures, percutaneous biopsies or\r\n             placement of vascular access device  1 week prior to starting study drug, or who have\r\n             not recovered from side effects of such procedure or injury.\r\n\r\n             4 Patients with impaired cardiac function or clinically significant cardiac diseases,\r\n             including any of the following:\r\n\r\n               -  History or presence of serious uncontrolled ventricular arrhythmias\r\n\r\n               -  Any of the following within 6 months prior to starting study drug: myocardial\r\n                  infarction (MI), severe/unstable angina, Coronary Artery Bypass Graft (CABG),\r\n                  Congestive Heart Failure (CHF), Cerebrovascular Accident (CVA), Transient\r\n                  Ischemic Attack (TIA), Pulmonary Embolism (PE)\r\n\r\n               -  Uncontrolled hypertension (defined by a SBP  160 mm Hg or DBP  100 mm Hg while\r\n                  on anti-hypertensive medications) or history of hypertensive crisis or\r\n                  hypertensive encephalopathy, stroke, TIA, symptomatic peripheral vascular\r\n                  disease, or grade 2 CHF 5 Patients with cirrhosis, or active viral or non-viral\r\n                  hepatitis. 6 Patients with peptic ulcer, abdominal fistula, gastrointestinal\r\n                  perforation, intra-abdominal abscess within 6 months of enrollment.\r\n\r\n                  7 Implanted pacemaker, defibrillator or deep brain stimulator, other implanted\r\n                  electronic devices in the brain or documented clinically significant arrhythmias.\r\n\r\n                  8 Infra-tentorial tumor. 9 Known sensitivity to conductive hydrogels. 10 Known\r\n                  diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not\r\n                  mandatory).\r\n\r\n                  11 Other concurrent severe and/or uncontrolled concomitant medical conditions\r\n                  (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause\r\n                  unacceptable safety risks or compromise compliance with the protocol 12 Pregnant\r\n                  or breast-feeding women. 13 Patients unwilling or unable to comply with the\r\n                  protocol. 14 Patients treated on any other therapeutic clinical protocols within\r\n                  3 weeks of starting on this study.\r\n      ","sponsor":"University of Maryland, Baltimore","sponsor_type":"Other","conditions":"RECURRENT GLIOBLASTOMA|Brain Tumor","interventions":[{"intervention_type":"Device","name":"Device: Optune(NOVOTTF-100A)"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Adverse Events with a grade 3 or high toxicity (Primary Measure)","time_frame":"6 months","description":"The ability to complete protocol treatment (i.e. tri-modality treatment) without undue acute toxicity as defined below\r\n: <40% rate of Grade 3 or higher nonhematologic toxicity.\r\n: <15% rate of Grade 4 or higher nonhematologic toxicity\r\n: <5% rate of Grade 4+ scalp dermatitis\r\n: <50% rate of Grade 2-3 scalp dermatitis\r\nEarly stopping rules: Two or more Grade 2 or higher symptomatic CNS hemorrhages; Eight treatment-related Grade 3 or higher non hematologic or Grade 4 or higher hematologic toxicities."}]}
{"nct_id":"NCT02156921","start_date":"2014-05-31","phase":"N/A","enrollment":34,"brief_title":"App-guided Training in eFAST Ultrasound","official_title":"Cost-effectiveness of Mobile App-guided Training in Extended Focused Assessment With Sonography for Trauma (eFAST): A Randomized Trial","primary_completion_date":"2014-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-10-31","last_update":"2016-10-27","description":"This study aims to investigate the cost-effectiveness of app-based self-directed ultrasound training compared to self-directed training with written handouts on subsequent performance on simulated patient cases and theoretical cases.","other_id":"H-3-2014-FSP17","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"Single","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  First year medical doctor\r\n\r\n          -  Provided written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior practical ultrasonography experience such as performing independent\r\n             ultrasonography scans, or participation in any post-graduate ultrasonography courses.\r\n      ","sponsor":"Rigshospitalet, Denmark","sponsor_type":"Other","conditions":"Learning Outcome|Training Efficiency","interventions":[{"intervention_type":"Other","name":"Other: App-based training"}],"outcomes":[{"outcome_type":"primary","measure":"Video recording of ultrasound skills, rated by consultant radiologists.","time_frame":"Ratings are to be completed within three months of performance.","description":"The video-recordings of the technical performances are merged with the ultrasonography screen-recordings to one anonymized video-clip. These combined video-clips are rated with the OSAUS rating by two raters. The OSAUS scale (Objective Structured Assessment of Ultrasound Skills) is used for all performance assessments. The raters are consultant radiologists."},{"outcome_type":"primary","measure":"Cost-effectiveness of mobile app guided versus textbook guided training","time_frame":"September 2016"},{"outcome_type":"secondary","measure":"Diagnostic accuracy","time_frame":"On site via checklist, evaluated on average one day after performance.","description":"Participants are given five videocases, to assess for eFAST verifiable pathology."}]}
{"nct_id":"NCT02142257","start_date":"2014-05-31","enrollment":100,"brief_title":"Comparison of Gastric Bypass and AspireAssist Aspiration Therapy for Treatment of Morbid Obesity","official_title":"Gastric Bypass Procedure and AspireAssist Aspiration Therapy System for the Treatment of Morbid Obesity, Observational Study Over 5 Years","primary_completion_date":"2020-05-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2020-05-31","last_update":"2018-04-30","description":"The purpose of this study is to compare Gastric Bypass and AspireAssist Aspiration Therapy over 5 years of treatment with regards to weight loss, quality of life, complications, adverse events, and health economics.","other_id":"2013/12","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":20,"maximum_age":60,"population":"The study is a prospective investigation of patients in Blekinge with a diagnosis of\r\n        obesity. A total of 100 patients will be included consecutively in the study. The\r\n        distribution will be 50 patients for each group. Recruitment for Gastric Bypass is made\r\n        from the clinic's waiting list for obesity surgery and for AspireAssist those individuals'\r\n        self-reported interest for treatment with AspireAssist.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  age 20-60 years\r\n\r\n          -  body mass index over 35\r\n\r\n          -  the absence of an eating disorder\r\n\r\n          -  severe co-morbidity\r\n\r\n          -  failure to achieve weight loss with lifestyle changes or other conservative approaches\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Recent myocardial infarction (3 months)\r\n\r\n          -  Ongoing cancer\r\n\r\n          -  Chronic liver and / or kidney disease\r\n\r\n          -  Mental illness, including substance abuse and eating disorders that can exclude the\r\n             patient from aspiration therapy.\r\n\r\n          -  Discovery of severe disease of the stomach on endoscopy\r\n      ","sponsor":"Blekinge County Council Hospital","sponsor_type":"Other","conditions":"Obesity","interventions":[{"intervention_type":"Procedure","name":"Procedure: Gastric Bypass","description":"Gastric Bypass surgery reduces the size of the stomach by use of staples. The smaller gastric pouch is then connected to the intestine bypassing a portion of the small intestine."},{"intervention_type":"Device","name":"Device: AspireAssist Aspiration Therapy","description":"AspireAssist employs an endoscopically placed A-Tube (similar to a gastrostomy tube) and a Companion system which facilitates portion control by aspiration of stomach contents 20 minutes after each meal combined with behavioral Therapy."}],"outcomes":[{"outcome_type":"primary","measure":"Weight Loss","time_frame":"year 1 - quarterly, years 2-5 once per year","description":"% Excess Weight loss based on ideal body weight with BMI of 25"},{"outcome_type":"secondary","measure":"Quality of Life","time_frame":"annually, up to 5 years","description":"Quality of Life survey according to EQ-5D EuroQol survey"},{"outcome_type":"other","measure":"Complications","time_frame":"within 30 days of procedure, after 30 days","description":"any surgical or post surgical complications, therapy related illness or adverse events"}]}
{"nct_id":"NCT02258282","start_date":"2014-05-31","phase":"N/A","enrollment":80,"brief_title":"Safety and Efficacy of Etanercept in Patients With Psoriasis","primary_completion_date":"2022-12-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2022-12-31","last_update":"2017-04-04","description":"The purpose of this study is to evaluate safety and efficacy of etanercept in patients with psoriasis who had an unsatisfactory response to traditional DMARDs.","other_id":"YSP20140688","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  has plaque psoriasis and has shown an unsatisfactory response to traditional DMARDs\r\n\r\n          -  18 to 75 years old\r\n\r\n          -  has PGA of 3 or more at Day 0\r\n\r\n          -  has BSA of 3% or more at Day 0\r\n\r\n          -  has psoriasis severe enough to be eligible to systemic therapy\r\n\r\n          -  willing to use an effective method of contraception for at least 30 days before Day 0\r\n             and until at least 1 month after the last drug administration;\r\n\r\n          -  capable of giving informed consent\r\n\r\n          -  with normal or non clinically significant chest X-ray within 6 months prior to Day 0\r\n\r\n          -  with negative Purified Protein Derivative (PPD) or Quantiferon TB Gold test within 90\r\n             days prior to Day 0\r\n\r\n          -  female patients of childbearing potential have a negative serum pregnancy test\r\n\r\n          -  patient is able to start etanercept per the approved product monograph\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  has used topical steroids, topical tar preparations, or other anti-psoriatic\r\n             preparations within the two weeks prior to Day 0 or during the study period\r\n\r\n          -  has presence of erythrodermic, pustular or guttate psoriasis\r\n\r\n          -  has had significant infections within the 30 days prior to Day 0\r\n\r\n          -  has received investigational drugs within the four weeks prior to screening or during\r\n             the study period\r\n\r\n          -  has been treated with systemic anti-psoriatic drugs such as steroids, retinoids,\r\n             cyclosporine, PUVA therapy or methotrexate within the four weeks prior to Day 0 or\r\n             during the study period\r\n\r\n          -  received systemic antibiotics within the four weeks prior to Day 0\r\n\r\n          -  has been treated with ultraviolet light therapy (UVB, nbUVB) within the two weeks\r\n             prior to Day 0 or during the study period\r\n\r\n          -  has used infliximab within 14 days of Day 0 or during the study period\r\n\r\n          -  has used other biologic agents for the treatment of psoriasis besides etanercept 8\r\n             weeks prior to Day 0 or during the study period\r\n\r\n          -  has had an allergic reaction to infliximab\r\n\r\n          -  has an unstable or serious medical condition as defined by the investigator or\r\n             presence of any significant medical condition that might cause this study to be\r\n             detrimental to the patient\r\n\r\n          -  uncontrolled or severe comorbidities such as poorly controlled diabetes mellitus, NYHA\r\n             class III or IV heart failure, history of myocardial infarction or cerebrovascular\r\n             accident or transient ischemic attack within three months of screening visit; unstable\r\n             angina pectoris\r\n\r\n          -  uncontrolled hypertension, oxygen-dependent severe pulmonary disease\r\n\r\n          -  has a known sero-positivity for HIV virus or history of any other immunosuppressive\r\n             disease\r\n\r\n          -  has active or chronic Hepatitis B or C\r\n\r\n          -  has any mycobacterial disease, patient with a chest X-Ray suggestive of tuberculosis\r\n             or patient taking anti-tuberculosis medication\r\n\r\n          -  has a known hypersensitivity to etanercept or one of its components\r\n\r\n          -  has received a live attenuated vaccine within the 12 weeks prior to Day 0 or plans to\r\n             receive one during the study\r\n\r\n          -  current pregnancy or lactation\r\n      ","sponsor":"Chengdu PLA General Hospital","sponsor_type":"Other","conditions":"Psoriasis","interventions":[{"intervention_type":"Drug","name":"Drug: Etanercept"},{"intervention_type":"Drug","name":"Drug: Control"}],"outcomes":[{"outcome_type":"primary","measure":"Changes from baseline of Physician's Global Assessment (PGA) at 24 weeks","time_frame":"At 0 week, 12 weeks, 24 weeks"},{"outcome_type":"secondary","measure":"Mean Body Surface Area (BSA)","time_frame":"At 0 week, 12 weeks, 24 weeks"},{"outcome_type":"secondary","measure":"Mean Psoriasis Area and Severity Index (PASI)","time_frame":"At 0 week, 12 weeks, 24 weeks"}]}
{"nct_id":"NCT02139098","start_date":"2014-05-31","phase":"Phase 3","enrollment":23,"brief_title":"Alternative Dosing Regimens in the Pharmacotherapy of Insomnia","official_title":"Phase III Study on Alternative Dosing Regimens in the Pharmacotherapy of Mild to Moderate Insomnia","primary_completion_date":"2017-11-30","study_type":"Interventional","rec_status":"Terminated","completion_date":"2017-11-30","last_update":"2018-03-09","description":"The purpose of this study is to evaluate whether drug efficiency of zolpidem and amitriptyline can be conditioned according to learning theory in patients with primary insomnia.","other_id":"FOR1328-SP8","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":69,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. age between 18 years to 69 years\r\n\r\n          2. fluent in German language\r\n\r\n          3. provide written informed consent\r\n\r\n          4. ability to understand the explanations and instructions given by the study physician\r\n             and the investigator\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Sleep disorders caused by medical factors (e.g. sleep apnea, restless legs syndrome,\r\n             narcolepsy, substance-induced insomnia)\r\n\r\n          2. Contraindications to study medication intake according to the information sheet for\r\n             health professionals (Summary of medicinal Product Characteristics, SmPC;\r\n             Fachinformation in Germany) assessed by physical examination (including ECG) and\r\n             medical history\r\n\r\n               -  allergies to amitriptyline hydrochloride or any of its ingredients\r\n\r\n               -  allergies to zolpidem or any of its ingredients\r\n\r\n               -  acute intoxication with alcohol, analgetics, hypnotics or any other psychotropic\r\n                  drug\r\n\r\n               -  urinary retention\r\n\r\n               -  delirium\r\n\r\n               -  untreated closed-angle glaucoma\r\n\r\n               -  prostatic hyperplasia\r\n\r\n               -  pyloric stenosis\r\n\r\n               -  paralytic ilius\r\n\r\n               -  suicidal thoughts\r\n\r\n               -  liver/ kidney/ pulmonary insufficiency\r\n\r\n               -  myasthenia gravis\r\n\r\n               -  hypokalemia\r\n\r\n               -  bradycardia\r\n\r\n               -  coronary heart disease, cardiac arrhythmias, long QT syndrome or other clinically\r\n                  relevant cardiac disorders\r\n\r\n               -  increased risk of seizures/ history of seizures\r\n\r\n               -  substance dependence syndrome/ history of substance dependence syndrome\r\n\r\n          3. Allergies to ingredients of placebo or novel-tasting drink (CS)\r\n\r\n          4. currently pregnant (verified by urine pregnancy test) or lactating\r\n\r\n          5. patients scoring 12 on the Epworth Sleepiness Scale\r\n\r\n          6. patients scoring below 8 or above 21 on the Insomnia Severity Index\r\n\r\n          7. patients suffering from a mental disorder as verified by the SCID (major depression;\r\n             psychosis; brain injury; substance abuse or dependency syndrome during the last 6\r\n             months before V1)\r\n\r\n          8. nicotine consumption > 10 cigarettes/day\r\n\r\n          9. unwillingness to refrain from alcohol consumption throughout the study\r\n\r\n         10. Concomitant medication interfering with study medication intake due to potential\r\n             interactions (all psychotropic medication including analgetics and muscle relaxants,\r\n             hypericum derivatives; antihypertensives; anti-arrhythmic agents; antibiotics;\r\n             cisaprid; anti-malaria drugs; diuretics; imidazole antifungals; cumarin derivatives;\r\n             antihistaminics; calcium channel blockers; medications that enlarge the QT interval or\r\n             may lead to hypokalemia)\r\n\r\n         11. change in concomitant medication regime during the last 2 weeks prior to visit 1 or\r\n             after randomization\r\n\r\n         12. intake of psychotropic medication during the last 3 months\r\n\r\n         13. participation in any other clinical trial 3 months prior to visit 1\r\n\r\n         14. women of childbearing age not using 2 highly effective contraceptive methods\r\n\r\n         15. employee of the Sponsor or the principal investigator\r\n      ","sponsor":"Philipps University Marburg Medical Center","sponsor_type":"Other","conditions":"Insomnia","interventions":[{"intervention_type":"Drug","name":"Drug: Amitriptyline","description":"50 mg capsule amitriptyline before going to bed on 8 out of 17 nights"},{"intervention_type":"Drug","name":"Drug: Zolpidem","description":"5 mg capsule zolpidem before going to bed on 8 out of 17 nights"},{"intervention_type":"Drug","name":"Drug: Amitriptyline","description":"50 mg capsule amitriptyline before going to bed on 13 out of 17 nights"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"Objective Sleep Onset Latency","time_frame":"Change from baseline to day 10 after first medication intake","description":"assessed by polysomnography"},{"outcome_type":"primary","measure":"Objective Total Sleep Time","time_frame":"Change from baseline to day 10 after first medication intake","description":"assessed by polysomnography"},{"outcome_type":"primary","measure":"Self-reported Total Sleep Time","time_frame":"Change from baseline to day 10 after first medication intake","description":"assessed by sleep diary"},{"outcome_type":"primary","measure":"Self-Reported Sleep Onset Latency","time_frame":"Change from baseline to day 10 after first medication intake","description":"assessed by sleep diary"},{"outcome_type":"secondary","measure":"Percentage of REM sleep","time_frame":"Change from baseline to day 10 after first medication intake","description":"assessed by polysomnography"},{"outcome_type":"secondary","measure":"REM onset latency","time_frame":"Change from baseline to day 10 after first medication intake","description":"assessed by polysomnography"},{"outcome_type":"secondary","measure":"Objective Sleep Efficiency","time_frame":"Change from baseline to day 17 after first medication intake","description":"assessed by actigraphy"},{"outcome_type":"secondary","measure":"Objective Total Sleep Time","time_frame":"Change from baseline to day 17 after first medication intake","description":"assessed by actigraphy"},{"outcome_type":"secondary","measure":"Self-Reported Total Sleep Time","time_frame":"Change from baseline to day 18 after first medication intake","description":"assessed by sleep diary"},{"outcome_type":"secondary","measure":"Self-reported Sleep Onset Latency (min)","time_frame":"Change from baseline to day 18 after first medication intake","description":"assessed by sleep diary"},{"outcome_type":"secondary","measure":"Self-reported Sleep Onset Latency (evaluation)","time_frame":"Change from baseline to day 18 after first medication intake","description":"assessed by sleep diary"}]}
{"nct_id":"NCT02999048","start_date":"2014-05-31","phase":"Phase 4","enrollment":90,"brief_title":"Clinical Study on the Treatment of Hypertensive Intracerebral Hemorrhage With Panax Notoginseng Saponin","official_title":"Clinical Study on the Treatment of Hypertensive Cerebral Hemorrhage With Panax Notoginseng Saponins","primary_completion_date":"2016-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-05-31","last_update":"2016-12-21","description":"The purpose of this study is to determine whether panax notoginseng saponins are effective in the treatment of Hypertensive Intracerebral Hemorrhage Patients.","other_id":"2012CC47","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":50,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  with a history of hypertension treated with medication and blood pressure management (\r\n             a systolic blood-pressure target of 140 to 179 mmHg and a diastolic blood-pressure\r\n             target of 70 to 100 mmHg) during the period of hospitalization,\r\n\r\n          -  the site of hematoma located in one of the cerebral hemispheres,\r\n\r\n          -  hematoma volume 10-30ml,\r\n\r\n          -  no blood in the ventricles,\r\n\r\n          -  within 24 hours of onset of first-time acute intracerebral hemorrhage,\r\n\r\n          -  no loss of consciousness (drowsiness acceptable).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  cerebellar or brainstem hemorrhage,\r\n\r\n          -  intracerebral hemorrhage caused by bleeding diathesis, aneurysms, vascular\r\n             malformations, improperly using anticoagulant drugs, or suspicious amyloid angiopathy,\r\n\r\n          -  subarachnoid hemorrhage; multifocal hemorrhage,\r\n\r\n          -  mixed stroke or hemorrhagic infarct,\r\n\r\n          -  coexisting systematic diseases such as heart or kidney failure, tumors,\r\n             gastrointestinal hemorrhage and so on,\r\n\r\n          -  pregnant or lactating women,\r\n\r\n          -  a history of XUESAITONG injection anaphylaxis.\r\n      ","sponsor":"The First People's Hospital of Jingzhou","sponsor_type":"Other","conditions":"Hematoma Absorption and Neurological Function Recovery","interventions":[{"intervention_type":"Drug","name":"Drug: Panax Notoginseng Saponins","description":"Panax Notoginseng Saponins integrated with conventional therapy"}],"outcomes":[{"outcome_type":"primary","measure":"Hematoma volume","time_frame":"within the 14 days after two weeks of intervention"},{"outcome_type":"primary","measure":"National Institutes of Health Stroke Scale (NIHSS) scores","time_frame":"within the 14 days after two weeks of intervention","description":"were measured for stroke severity"},{"outcome_type":"primary","measure":"Barthel index","time_frame":"within the 14 days after two weeks of intervention","description":"were measured for quality of life"},{"outcome_type":"secondary","measure":"adverse events","time_frame":"14 days","description":"such as rash, allergic shock"}]}
{"nct_id":"NCT02147275","start_date":"2014-05-31","enrollment":41,"brief_title":"Monitoring Hypertensive Patients's Cerebral Oxygen Saturation","official_title":"Monitoring Cerebral Oxygen Saturation in Hypertensive Patients Undergoing Major Abdominal Surgery","primary_completion_date":"2014-11-30","study_type":"Observational","rec_status":"Completed","completion_date":"2014-11-30","last_update":"2014-11-11","description":"The purpose of this study is to determine whether there is a significant decrease in cerebral oxygen saturation in hypertensive patients undergoing major abdominal surgery and their correlation with standard monitoring parameters.","other_id":"TJH-AD-12888","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":30,"maximum_age":80,"population":"patients scheduled for major abdominal surgery such as gastrectomy, colon resection ,liver\r\n        resection and duodenocephalo-pancreasectomy","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  patients have hypertension more than 3 year,whether well-controlled or uncontrolled,\r\n\r\n          -  scheduled for major abdominal surgery for at least 2 h\r\n\r\n          -  under general anesthesia\r\n\r\n          -  American Society of AnesthesiologistsASAphysical status : II ~ III\r\n\r\n          -  Age > 30\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  pre-existing cerebral pathology for example episodes of cerebral ischemia or stroke;\r\n\r\n          -  ASA physical status >IV\r\n\r\n          -  hepatic failure\r\n\r\n          -  renal failure\r\n\r\n          -  preoperative Mini-Mental State Examination (MMSE) score less than 24\r\n\r\n          -  a history of cardiovascular surgery or craniotomy\r\n\r\n          -  cardiac failure\r\n\r\n          -  respiratory failure\r\n      ","sponsor":"Huazhong University of Science and Technology","sponsor_type":"Other","conditions":"Surgical Complications From General Anesthesia|Hypertension|Cerebral Ischemia|Cerebral Anoxia","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"decreases in cerebral oxygen saturation (rSO2) during the surgery","time_frame":"every 5 minutes throughout the surgery"},{"outcome_type":"secondary","measure":"Change from baseline in Mini-Mental State Exam (MMSE) perioperative period","time_frame":"Baseline, 4 day after surgery"}]}
{"nct_id":"NCT02055924","start_date":"2014-05-26","phase":"Phase 1","enrollment":85,"brief_title":"Bruton's Tyrosine Kinase (BTK) Inhibition in B-cell Lymphomas","official_title":"A Phase Ib Study of Ibrutinib Combined With R-DHAP or R-DHAOx in Patients With B-cell Lymphomas","primary_completion_date":"2017-12-01","study_type":"Interventional","rec_status":"Terminated","completion_date":"2018-10-09","last_update":"2018-10-11","description":"This is an open label, multicenter, dose escalation, phase Ib study to determine the recommended dose by assessing the maximum tolerated dose (MTD), safety and efficacy of ibrutinib in combination with R-DHAP (Group A/Abis) or R-DHAOx (Group B/Bbis) for patients with B-cell malignancies. This dose escalation will be followed by an exploratory expansion phase in 3 groups of 12 patients each (Group A/Abis, Group B/B bis and Group C). During Part 1 Dose Escalation, the \"3+3\" design will be applied. Three doses of ibrutinib (280, 420 and 560 mg) will be examined sequentially in each cohort by the Dose Escalation Committee. Dose escalation will begin at dose level 1 = 420 mg. The dose escalation will be performed for two types of associations in five separate groups : - Group A : ibrutinib D1-D21+ R-DHAP - Group B : ibrutinib D1-D21 R-DHAOx - Group Abis : ibrutinib D5-D18+ R-DHAP - Group Bbis : ibrutinib D5-D18 R-DHAOx This dose escalation will be followed by an exploratory expansion phase in the group Bbis plus a new group including only mantle cell lymphoma (MCL) in first line patients: group C. Patients included in the Group C will receive ibrutinib in combination with R-DHAP or R-DHAOx according to the choice of the local investigator at time of inclusion of each patient.","other_id":"BIBLOS","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patients with any type of relapsed or refractory B-cell lymphoma will be eligible in\r\n             groups A, A bis, B and B bis (during the dose escalation and the expansion parts of\r\n             the study) and untreated patients with mantle cell lymphoma will be eligible for group\r\n             C (only during the expansion part of the study)\r\n\r\n          2. Each patient (or their legally acceptable representative) must sign an informed\r\n             consent form (ICF) indicating that he or she understands the purpose of and procedures\r\n             required for the study and are willing to participate in the study\r\n\r\n          3. Patients eligible for autologous stem cell transplantation (ASCT) for whom R-DHAP or\r\n             R-DHAOx is an acceptable therapy regarding the investigator's opinion\r\n\r\n          4. Measurable disease defined by at least one single node or tumor lesion > 1.5 cm\r\n\r\n          5. Patients who received prior therapy with at least one but no more than two lines\r\n             therapies for B-Cell Lymphoma (except for patients included in group C during the\r\n             expansion part of the study)\r\n\r\n          6. Aged between 18 years and 70 years (included)\r\n\r\n          7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2\r\n\r\n          8. Any of the following hematology values within 14 days prior to inclusion and prior to\r\n             the first dose of study drug :\r\n\r\n               1. Absolute neutrophil count (ANC) > 1,000 cells/mm3 (1.0 x 109/L) unless if bone\r\n                  marrow infiltration from lymphoma\r\n\r\n               2. Spontaneous Platelets count > 75,000 cells/mm3 (75 x 109/L) within 7 days of any\r\n                  platelet transfusion (allowed up to 50 x 109/L if due to bone marrow infiltration\r\n                  from lymphoma)\r\n\r\n          9. Patients assessed as being able to receive full doses of R-DHA(P/Ox) for 3 cycles or 4\r\n             cycles for patients included in group C of the expansion phase\r\n\r\n         10. Life expectancy of  90 days (3 months)\r\n\r\n         11. Women of childbearing potential* and men who are sexually active must be practicing a\r\n             highly effective method of birth control during the study and during 12 months after\r\n             the end of treatments. Men must agree to not donate sperm during the study and during\r\n             12 months after the end of treatments\r\n\r\n         12. Women of childbearing potential must have a negative serum beta human chorionic\r\n             gonadotropin (-hCG) or urine pregnancy test at Screening\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Previous treatment with a BTK inhibitor\r\n\r\n          2. Patients who progressed or became refractory while on treatment with a\r\n             phosphoinositide 3-kinase (PI3K) inhibitors\r\n\r\n          3. Inability to tolerate 4 courses of high dose ara-C / platin compound, especially if\r\n             due to underlying comorbidities\r\n\r\n          4. History of stroke or intracranial hemorrhage within 6 months prior to the first dose\r\n             of study drug\r\n\r\n          5. Major surgery, within 4 weeks prior to the first dose of study drug\r\n\r\n          6. Known bleeding diathesis\r\n\r\n          7. Condition that requires therapeutic anticoagulation with Vitamin K antagonists\r\n\r\n          8. Condition that requires treatment with a strong cytochrome P450 3A4/5 (CYP3A4/5)\r\n             inhibitor\r\n\r\n          9. Any life-threatening illness, serious medical condition, laboratory abnormality, organ\r\n             system dysfunction or psychiatric illness which, in the investigator's opinion, could\r\n             compromise the patient's safety, interfere with the absorption or metabolism of\r\n             ibrutinib capsules, or put the study outcomes at undue risk and that would prevent the\r\n             patient from signing the informed consent form\r\n\r\n         10. Known central nervous system or meningeal involvement by lymphoma\r\n\r\n         11. Contraindication to any drug contained in these regimen\r\n\r\n         12. Known history of human immunodeficiency virus (HIV)\r\n\r\n         13. Known active Hepatitis C Virus (HCV; RNA polymerase chain reaction (PCR)-positive) or\r\n             active Hepatitis B Virus infection (HBs Ag positive or DNA PCR-positive) or any\r\n             uncontrolled active systemic infection requiring intravenous (IV) antibiotics.\r\n             Patients with PCR-negative for hepatitis B virus (HBV) are permitted in the study.\r\n\r\n         14. Left ventricular ejection fraction (LVEF) < 45% as determined by echocardiography or\r\n             multiple uptake gated acquisition (MUGA) scan\r\n\r\n         15. Clinically significant cardiovascular disease such as uncontrolled or symptomatic\r\n             arrhythmias, congestive heart failure, or myocardial infarction within 6 months prior\r\n             to the first dose of study drug, or any Class 3 (moderate) or Class 4 (severe) cardiac\r\n             disease as defined by the New York Heart Association Functional Classification\r\n\r\n         16. Any of the following biochemical values within 14 days prior to inclusion and prior to\r\n             the first dose of study drug :\r\n\r\n               1. Serum glutamic-oxaloacetic transaminase/aspartate aminotransferase (SGOT/ASAT) or\r\n                  serum glutamic-pyruvic transaminase/alanine aminotransferase (SGPT/ALAT) > 3.0 x\r\n                  upper limit of normal (ULN)\r\n\r\n               2. Serum total bilirubin > 2.0 mg/dL (34 mol/L), except in patients with hemolytic\r\n                  anemia or with Gilbert syndrome,\r\n\r\n               3. Calculated creatinine clearance of < 50 mL /min (for patients who will have DHAOx\r\n                  chemotherapy) or < 70 mL/min (for patients who will have DHAP chemotherapy)\r\n\r\n         17. Patients with pre-existing  Grade 2 neuropathy\r\n\r\n         18. Prior history of malignancies other than lymphoma (except for basal cell or squamous\r\n             cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the\r\n             patient has been free of the disease for  3 years\r\n\r\n         19. Use of any standard or experimental anti-cancer drug therapy within 28 days prior to\r\n             the first dose of study drug\r\n\r\n         20. Women who are pregnant or breastfeeding\r\n\r\n         21. Medical history of hepatic chronic disease whatever the anteriority\r\n\r\n         22. Sinusoidal obstruction syndrome (Veno-Occlusive Disease (VOD)) whatever the\r\n             anteriority\r\n      ","sponsor":"The Lymphoma Academic Research Organisation","sponsor_type":"Other","conditions":"B-cell Lymphoma","interventions":[{"intervention_type":"Drug","name":"Drug: Ibrutinib and immunochemotherapies","description":"Combination of immunochemotherapies (R-DHAP or R-DHAOx) and ibrutinib"}],"outcomes":[{"outcome_type":"primary","measure":"The primary endpoint is the incidence rate of DLTs at each dose level on cycle 1","time_frame":"21 days","description":"Determine the recommended phase II dose (RP2D) of ibrutinib when administered in combination with R-DHAP (rituximab + dexamethasone + cytarabine + cisplatin) or with R-DHAOx (rituximab + dexamethasone + cytarabine + oxaliplatin) in patients with relapsed or refractory B-cell malignancies eligible for autologous stem cell transplantation (ASCT) by assessing the maximum tolerated dose (MTD) observed during the dose escalation part of the study. Assessment of the MTD will be performed by the analysis of the dose-limiting toxicities (DLTs)."},{"outcome_type":"secondary","measure":"Secondary safety endpoints","time_frame":"84 days","description":"Study drug administration including treatment duration, average dose, dose reduction; Treatment discontinuation, study discontinuation; Adverse events, vital sign measurements, clinical laboratory measurements, and concomitant therapies."},{"outcome_type":"secondary","measure":"Response Rate","time_frame":"30 days after the last dose of study drug is administered","description":"Disease response evaluation at 3 cycles (or 4 cycles for patients with mantle cell lymphoma in first line in the expansion phase) will be used to determine the Response Rate. Response after 3 cycles (or 4 cycles) will be assessed at the end of completion of the cycles if patient received all cycles or at withdrawal"},{"outcome_type":"secondary","measure":"Duration of response (DoR)","time_frame":"from first evidence of response to the date of first documented disease progression, relapse or death from any cause, assessed up to 52 months","description":"Duration of response is defined as the time from first evidence of response (PR or better) to first documented disease progression, relapse or death from any cause. Patients alive and free of progression at data cut-off will be censored at the last adequate tumor assessment indicating no disease progression"},{"outcome_type":"secondary","measure":"Progression-Free Survival (PFS)","time_frame":"from the date of inclusion to the date of first observation of documented disease progression or death due to any cause, assessed up to 52 months","description":"PFS is defined as the time from inclusion into the study to the first observation of documented disease progression or death due to any cause. If a patient has not progressed or died, PFS will be censored at the time of last visit with adequate assessment. Patients without documented event at the time of analysis will be censored at their last follow-up date."},{"outcome_type":"secondary","measure":"Time to Next Anti-Lymphoma Treatment (TTNLT)","time_frame":"from the date of inclusion to the date of first documented administration of any new anti-lymphoma treatment, assessed up to 52 months","description":"TTNLT is defined as the time from the date of inclusion to the date of first documented administration of any new anti-lymphoma treatment (chemotherapy, radiotherapy, radio-immunotherapy, immunotherapy). Patients continuing in response or who are lost to follow-up will be censored on their last visit date. Patients who died (due to any cause) before having received a new anti-lymphoma treatment will be included in the statistical analysis with death being counted as an event."},{"outcome_type":"secondary","measure":"Overall Survival (OS)","time_frame":"from the date of inclusion to the date of death from any cause, assessed up to 52 months","description":"Overall survival is defined as the time from the date of inclusion to the date of death from any cause. Patients who did not die will be censored at their last follow-up date."},{"outcome_type":"secondary","measure":"Pharmacokinetics profile of ibrutinib in Groups A bis and B bis","time_frame":"During dose escalation part, on first day of ibrutinib administration (Day 5) and on Day 15 of cycle 1 and cycle 2","description":"The objective is to assess the pharmacokinetic profile of ibrutinib in the presence of R-DHA(P/Ox) for groups A bis and B bis during the dose escalation part."}]}
{"nct_id":"NCT02129257","start_date":"2014-05-26","phase":"Phase 2","enrollment":73,"brief_title":"Clinical Trial of Combination Chemotherapy With Aflibercept in Patients With Advanced Colorectal Cancer","official_title":"Single-arm Phase II Study of Maintenance Therapy With Aflibercept After First-line Treatment With FOLFIRI Plus Aflibercept in Metastatic Colorectal Cancer Patients","primary_completion_date":"2017-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-09-25","last_update":"2017-10-24","description":"The AMALTHEA (Aflibercept MAintenance after first-Line THErapy with FOLFIRI+Aflibercept in metastatic colorectal cancer patients) trial is an investigator-initiated, single arm, open-label, phase II study. Patients with histologically proven metastatic colorectal carcinoma will be treated with a combination of FOLFIRI and aflibercept for 6 months. Both Kirsten rat sarcoma viral oncogene homolog (KRAS) wild type (wt) and mutant (mut) patients wil be enrolled. In the absence of Progressive Disease (PD) after 6 months of the combination of chemotherapy and aflibercept, the patient will be treated with a maintenance therapy with aflibercept alone until PD or unacceptable toxicity, investigator's decision or patient's refusal of further treatment or death, whichever comes first.","other_id":"HE 6A/13","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria\r\n\r\n          -  Histologically proven adenocarcinoma of the colon and/or rectum\r\n\r\n          -  Metastatic disease confirmed clinically/radiologically\r\n\r\n          -  Signed written informed consent\r\n\r\n          -  No prior therapy for metastatic disease\r\n\r\n          -  Duly documented inoperable metastatic disease, ie not suitable for complete curative\r\n             surgical resection\r\n\r\n          -  At least one measurable or evaluable lesion as assessed by Computed Tomography (CT)\r\n             scan or MRI (Magnetic Resonance Imaging) according to Response Evaluation Criteria In\r\n             Solid Tumors (RECIST) v1.1\r\n\r\n          -  Age 18 years\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2\r\n\r\n          -  Adequate hematological status:\r\n\r\n               -  neutrophils (ANC) 1.5x109/L\r\n\r\n               -  platelets 100x109/L\r\n\r\n               -  haemoglobin 9g/dL\r\n\r\n          -  Adequate renal function: serum creatinine level <1.5 mg/dl and Glomerular Filtration\r\n             Rate>50 ml/min by Cockroft/Gault formula\r\n\r\n          -  Adequate liver function:\r\n\r\n               -  serum bilirubin 1.5 x upper normal limit (ULN)\r\n\r\n               -  alkaline phosphatase\r\n\r\n               -  aspartate aminotransferase (AST)\r\n\r\n               -  alanine aminotransferase (ALT) < 5 x ULN\r\n\r\n          -  Proteinuria <2+ (dipstick urinalysis) or 1g/24hour\r\n\r\n          -  Regular follow-up feasible\r\n\r\n          -  Baseline evaluations performed before registration: clinical and blood evaluations no\r\n             more than 2 weeks (14 days) prior to registration, tumor assessment (chest X-ray,\r\n             CT-scan or MRI, evaluation of non-measurable lesions) no more than 3 weeks (21 days)\r\n             prior to registration\r\n\r\n          -  First course of treatment planned less than 1 week (7 days) after registration\r\n\r\n          -  For female patients of childbearing potential, negative serum pregnancy test within 1\r\n             week (7 days) prior of starting study treatment\r\n\r\n          -  Female patients must commit to using reliable and appropriate methods of contraception\r\n             until at least three months after the end of study treatment (when applicable). Male\r\n             patients with a partner of childbearing potential must agree to use contraception in\r\n             addition to having their partner use another contraceptive method during the trial.\r\n\r\n        Exclusion Criteria\r\n\r\n          -  Exclusive presence of bone metastasis only\r\n\r\n          -  Uncontrolled hypercalcemia\r\n\r\n          -  Uncontrolled hypertension (defined as systolic blood pressure >150 mmHg and/or\r\n             diastolic blood pressure >100 mmHg despite medical therapy), or history of\r\n             hypertensive crisis, or hypertensive encephalopathy\r\n\r\n          -  Concomitant unplanned antitumor therapy (e.g. chemotherapy, molecular targeted\r\n             therapy, immunotherapy)\r\n\r\n          -  Treatment with any other investigational medicinal product within 28 days prior to\r\n             study entry\r\n\r\n          -  Other serious and uncontrolled non-malignant chronic disease\r\n\r\n          -  History or presence of Central Nervous System (CNS) metastasis unless adequately\r\n             treated (e.g. non irradiated CNS metastasis, seizures not controlled with standard\r\n             medical therapy)\r\n\r\n          -  Gilbert's syndrome\r\n\r\n          -  Intolerance to atropine sulfate or loperamide\r\n\r\n          -  Known dihydropyrimidine dehydrogenase deficiency\r\n\r\n          -  Treatment with Cytochrome P450 3A4 (CYP3A4) inducers unless discontinued > 7 days\r\n             prior to randomization\r\n\r\n          -  Any of the following in 3 months prior to inclusion: grade 3-4 gastrointestinal\r\n             bleeding (unless due to resected tumor), treatment resistant peptic ulcer disease,\r\n             erosive esophagitis or gastritis, infectious or inflammatory bowel disease, or\r\n             diverticulitis\r\n\r\n          -  Other concomitant or previous malignancy, except:\r\n\r\n               -  adequately treated in-situ carcinoma of the uterine cervix\r\n\r\n               -  basal or squamous cell carcinoma of the skin\r\n\r\n               -  cancer in complete remission for >5 years\r\n\r\n          -  Any other serious and uncontrolled non-malignant disease, major surgery or traumatic\r\n             injury within the last 28 days\r\n\r\n          -  Pregnant or breastfeeding women\r\n\r\n          -  Patients with known allergy to any excipients to study drugs\r\n\r\n          -  History of myocardial infarction and/or stroke or other arterial thrombotic events or\r\n             pulmonary embolism or unstable angina pectoris within 6 months prior to registration\r\n\r\n          -  Poorly controlled cardiac arrhythmias\r\n\r\n          -  Bowel obstruction\r\n\r\n          -  History of severe tumour bleeding or bleeding disorders\r\n\r\n          -  Poorly controlled anti-coagulation therapy (INR>3.0 on coumadin or heparin compounds)\r\n\r\n          -  Palliative radiation therapy within 4 weeks prior to registration\r\n      ","sponsor":"Hellenic Cooperative Oncology Group","sponsor_type":"Other","conditions":"Metastatic Colorectal Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: AFLIBERCEPT"},{"intervention_type":"Drug","name":"Drug: Irinotecan"},{"intervention_type":"Drug","name":"Drug: 5-Fluorouracil"},{"intervention_type":"Drug","name":"Drug: Folinic Acid"}],"outcomes":[{"outcome_type":"primary","measure":"Progression-Free Survival (PFS) rate at 1 year","time_frame":"Up to 1 year"},{"outcome_type":"secondary","measure":"Evaluation of Objective Response Rate (ORR) defined as the proportion of patients with complete response (CR) or partial response (PR) among all patients, as assessed according to Response Evaluation Criteria for Solid Tumors (RECIST) v1.1","time_frame":"Up to 20 months","description":"Response to treatment will be described in a frequency table along with the corresponding percentages and 95% exact confidence intervals."},{"outcome_type":"secondary","measure":"Evaluation of Overall Survival (OS)","time_frame":"Time interval from registration to the date of death due to any cause assessed up to 60 months"},{"outcome_type":"secondary","measure":"Evaluation of Progression-Free Survival (PFS)","time_frame":"Time interval from registration to the first date of documented progression or death due to any cause assessed up to 60 months"},{"outcome_type":"secondary","measure":"Number of participants with Serious and Non-Serious Adverse Events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0","time_frame":"Up to 40 months","description":"Adverse Events of the safety population for the FOLFIRI-aflibercept treatment part and the maintenance therapy will be presented in frequency tables according to grade, along with the corresponding percentages (N,%)"},{"outcome_type":"secondary","measure":"Tumor tissue mRNA levels of VEGFA-121, VEGFA121b, VEGF-B, PlGF, VEGF-C, Semaphorins, HIF1, VEGFR1, VEGFR2, Neuropilins 1,2, Thrombospondin, Angiopoietins 1,2. Predictive significance for response rate, PFS, OS.","time_frame":"Tumor blocks will be collected at baseline"},{"outcome_type":"secondary","measure":"Steady-state concentration of free Aflibercept and VEGF-bound Aflibercept in plasma. Predictive significance for response rate, PFS, OS.","time_frame":"On day 1 of cycle 1, on day 1 of cycle 3, on day 1 of week 3 of Aflibercept maintenance monotherapy, at the end of treatment, assessed up to 20 months"},{"outcome_type":"secondary","measure":"Enzyme-linked immunosorbent assay (ELISA) plasma concentrations of VEGFA, soluble VEGFR1, soluble VEGFR2, VEGF-B, PlGF, basic fibroblast growth factor (bFGF), hepatocyte growth factor (HGF). Predictive significance for response rate, PFS, OS.","time_frame":"On day 1 of cycle 1, on day 1 of cycle 3, on day 1 of week 3 of Aflibercept maintenance monotherapy, at the end of treatment, assessed up to 20 months"}]}
{"nct_id":"NCT02689518","start_date":"2014-04-30","phase":"Phase 4","enrollment":50,"brief_title":"EAGLE: Evaluating Genotypes Using Intravitreal Aflibercept Injection","official_title":"Clinical and Genetic Assessment of Treatment Response in Patients With Age-related Macular Degeneration Using Intravitreal Aflibercept Injection","primary_completion_date":"2019-11-12","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-11-12","last_update":"2021-03-25","description":"Clinical and genetic evaluation of individuals treated with intravitreal aflibercept injection (Eylea) for neovascular age-related macular degeneration (wet AMD)","other_id":"EAGLE","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":50,"maximum_age":90,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age  50 years\r\n\r\n          2. Nave neovascular wet-AMD (has not received treatment before)\r\n\r\n          3. Willing and able to comply with clinic visits and study-related procedures\r\n\r\n          4. Provide signed informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Previous therapy in study eye for AMD or other retinal disease which may be used in\r\n             the treatment of AMD\r\n\r\n          2. Previous subfoveal focal laser photocoagulation involving the foveal center in the\r\n             study eye\r\n\r\n          3. History of vitrectomy, submacular surgery, or other surgical intervention for AMD in\r\n             the study eye\r\n\r\n          4. Any concurrent intraocular condition in the study eye (e.g. diabetic retinopathy or\r\n             glaucoma) that, in the opinion of the investigator, could either 4.1 require medical\r\n             or surgical intervention during the study period to prevent or treat visual loss that\r\n             might result from that condition, or 4.2 if allowed to progress untreated, could\r\n             likely contribute to loss of at least 2 Snellen equivalent lines of best corrected\r\n             visual acuity over the study period\r\n\r\n          5. Active intraocular inflammation (grade trace or above) in the study eye, or history of\r\n             idiopathic or autoimmune-associated uveitis in either eye\r\n\r\n          6. Current vitreous hemorrhage in the study eye\r\n\r\n          7. History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the\r\n             study eye\r\n\r\n          8. Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either\r\n             eye\r\n\r\n          9. Aphakia, ACIOL, or unstable PCIOL\r\n\r\n         10. Uncontrolled glaucoma in the study eye (defined as intraocular pressure 30 mmHg\r\n             despite treatment with anti-glaucoma medication)\r\n\r\n         11. Pregnant or breast-feeding women\r\n\r\n         12. Sexually active men* or women of childbearing potential** who are unwilling to\r\n             practice adequate contraception during the study (adequate contraceptive measures\r\n             include stable use of oral contraceptives or other prescription pharmaceutical\r\n             contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device\r\n             [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or\r\n             jelly, or diaphragm plus contraceptive sponge, foam, or jelly)\r\n\r\n         13. Any other condition that the investigator believes would pose a significant hazard to\r\n             the patient if the investigational therapy were initiated *Contraception is not\r\n             required for men with documented vasectomy. **Postmenopausal women must be amenorrheic\r\n             for at least 12 months in order not to be considered of child bearing potential.\r\n             Pregnancy testing and contraception are not required for women with documented\r\n             hysterectomy or tubal ligation.\r\n      ","sponsor":"University of California, San Diego","sponsor_type":"Other","conditions":"Macular Degeneration|Wet Macular Degeneration","interventions":[{"intervention_type":"Drug","name":"Drug: Intravitreal aflibercept injection","description":"Intravitreal aflibercept injection 2 mg (0.05 mL) administered every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) intravitreal injection once every 8 weeks(2 months) with the option to treat monthly based on retreatment criteria for a total duration of 12 months."}],"outcomes":[{"outcome_type":"primary","measure":"Anatomic Response","time_frame":"12 Months","description":"The primary endpoint in the study is the correlation of CFH, HTRA1, VEGFA, C3, TIMP3, APOE, CETP, LIPC, TGFBR1, CFI, and CFB allele frequencies and VEGA expression in lymphoblastoid cell lines with response to intravitreal aflibercept injection treatment, based on anatomic outcomes:\r\nEarly response (at Month 3) - o On optical coherence tomography(SD-OCT)\r\nReduction in central retinal thickness by ≥ 50%, OR\r\nCentral retinal thickness <300 um, OR\r\nAbsence of retinal fluid\r\nLater response (at Month 12) -\r\no On SD-OCT\r\nReduction in central retinal thickness by ≥ 50%, OR\r\nCentral retinal thickness < 300 um, OR\r\nAbsence of retinal fluid\r\nPoor response, defined as no reduction of fluid or central retinal thickness at Month 12."},{"outcome_type":"secondary","measure":"Visual/Treatment Response","time_frame":"12 Months","description":"The secondary endpoints are a correlation of CFH, VEGF, HTRA1, VEGFA, C3, TIMP3, APOE, CETP, LIPC, TGFBR1, CFI, and CFB allele frequencies:\r\nWith visual outcomes -\r\nEarly response, defined as a gain ≥ 0 letters at Month 3\r\nLater response, defined as a gain ≥ 0 letters at Month 12\r\nPoor response, defined as loss of visual acuity (gain <0 letters) at Month 12\r\nWith change in characteristics on fluorescein angiography and fundus photography (lesion size, lesion type, etc)\r\nWith number of injections through Month 12\r\no Mean number of intravitreal aflibercept injections required through Month 12 will be calculated for the group overall, and separately by response group (early, later, and no response to treatment)."},{"outcome_type":"other","measure":"Safety - Incidence and Severity of Ocular and Non-ocular Adverse Events","time_frame":"12 Months","description":"Incidence and severity of ocular and non-ocular adverse events using Aflibercept intravitreal injections will also be evaluated."}]}
{"nct_id":"NCT02130271","start_date":"2014-04-30","enrollment":42,"brief_title":"PET/MRI Imaging of Neuraxial Inflammation in Sciatica Patients","official_title":"PET/MRI Imaging of Neuraxial Inflammation in Sciatica Patients","primary_completion_date":"2016-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2018-12-31","last_update":"2019-09-16","description":"The purpose of this study is to see if the spine shows areas of inflammation using a specific type of imaging (pictures).","other_id":"2013P-002174","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":75,"population":"1. Subject is currently diagnosed with lower extremity radicular/sciatica pain.\r\n\r\n          2. Healthy subjects with no pain from the local community.","criteria":"\n        Inclusion criteria for pain subjects:\r\n\r\n          1. Subject is 18-75 years old.\r\n\r\n          2. Subject is able to give written informed consent.\r\n\r\n          3. Subject is currently diagnosed with lower extremity radicular pain regardless of\r\n             specific or suspected etiologies.\r\n\r\n          4. Subject has a clear dermatomal distribution of the painful area extending to the\r\n             distal lower extremities.\r\n\r\n          5. Subject reports ongoing pain intensity of 4 or greater using the visual analogue scale\r\n             (VAS) during the week prior to enrollment.\r\n\r\n        Inclusion criteria for healthy subjects:\r\n\r\n          1. Subject is 18-75 years old.\r\n\r\n          2. Subject is able to give written informed consent.\r\n\r\n          3. Subject has no history of chronic back/spine pain.\r\n\r\n        Exclusion criteria for all groups:\r\n\r\n          1. Subject recently received a lumbar ESI (within 8 weeks).\r\n\r\n          2. Subject starts new NSAID medication for pain during the study.\r\n\r\n          3. Subject has predominantly axial low back pain.\r\n\r\n          4. Subject has known pain condition secondary to hip joint arthritis.\r\n\r\n          5. Subject is pregnant or breastfeeding.\r\n\r\n          6. Subject has allergy to lidocaine.\r\n\r\n          7. Subject is treated with chronic corticosteroid therapy.\r\n\r\n          8. Subject is on anticoagulation therapy (i.e. Coumadin, Plavix, or Lovenox).\r\n\r\n          9. Subject has a known bleeding disorder (i.e. hemophilia).\r\n\r\n         10. Subject has uncontrolled high blood pressure [>170/100].\r\n\r\n         11. Subject has a known heart condition.\r\n\r\n         12. Subject has known inflammatory disease (i.e. inflammatory bowel disease; ankylosing\r\n             spondylitis; etc.).\r\n\r\n         13. Subject has known liver dysfunction or renal insufficiency or impaired elimination\r\n             (Renal dysfunction is defined as eGFR < 60. Hepatic dysfunction is defined as LFTs \r\n             3x ULN).\r\n\r\n         14. Subject has been hospitalized recently (within one month) for a major psychiatric\r\n             disorder (i.e. major depression, bipolar disorder, schizophrenia, anxiety disorder, or\r\n             psychosis).\r\n\r\n         15. Subject has contraindications to MRI and PET scanning (i.e. presence of a cardiac\r\n             pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the\r\n             head or previous neurosurgery, prosthetic heart valves, or claustrophobia).\r\n\r\n         16. Subject had research-related radiation exposure in the last 12 months.\r\n\r\n         17. Subject tests positive for use of illicit drugs, marijuana, or non-prescribed drugs.\r\n      ","sponsor":"Massachusetts General Hospital","sponsor_type":"Other","conditions":"Sciatica","interventions":[{"intervention_type":"Drug","name":"Drug: Radioactive dye","description":"The radioactive dye [11C]PBR28 will be administered through an intravenous line (IV)."},{"intervention_type":"Radiation","name":"Radiation: PET/MRI","description":"All subjects will undergo a simultaneous PET/MRI scan. The scan will be up to 2 hours long."},{"intervention_type":"Other","name":"Other: Blood draw","description":"Up to 11 tablespoons of blood will be drawn through an intravenous line (IV-line) for two purposes: 1) testing for the subject's genetic affinity to the radioactive dye, and 2) testing for the presence inflammatory biomarkers."}],"outcomes":[{"outcome_type":"primary","measure":"Inflammation in the spine","time_frame":"2 hours","description":"The presence of inflammation in the spine using the radioactive tracer [11C]PBR28."},{"outcome_type":"secondary","measure":"Pain Scores on the Visual Analog Scale (VAS)","time_frame":"up to 3 months","description":"The subject's pain score (VAS) at baseline and up to 3 months after the ESI treatment."}]}
{"nct_id":"NCT02232854","start_date":"2014-04-30","phase":"N/A","enrollment":256,"brief_title":"Training and Supervision Program for Depression Management","official_title":"Comprehensive Technology-Assisted Training and Supervision Program to Enhance Depression Management in Primary Care","primary_completion_date":"2016-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-06-30","last_update":"2017-10-25","description":"According to the literature the management of depressive disorders at primary care level is not always consistent with guidelines. The main objective of this study is to test whether a Comprehensive Technology-Assisted Training and Supervision Program will improve depression management in Primary Health Care clinics in Santiago, Chile.","other_id":"1130230","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  signing written informed consent\r\n\r\n          -  age between 18-65 years\r\n\r\n          -  current depressive episode, according to the Mini-International Neuropsychiatric\r\n             Interview (MINI)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  current depression treatment\r\n\r\n          -  no access to telephone\r\n      ","sponsor":"University of Chile","sponsor_type":"Other","conditions":"Depression","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Depression training/supervision program","description":"The intervention will be composed of:\r\nTraining of Primary Health Care teams to ensure compliance to the \"Clinical Guidelines of the Ministry of Health for the Treatment of Depression\". Primary Health Care teams will undergo an Objective Structured Clinical Examination (OSCE) for evaluation.\r\nAfter the training, a focus group between Primary Health Care teams and study researchers will be held in order to address barriers to clinical guidelines implementation.\r\nPrimary Health Care clinics' trained administrative staff will contact patients from a call-center to support treatment adherence.\r\nPsychiatrists, using a web-based platform, will supervise the course of the program, the allocated treatments, the patients' progress, and their response to treatment."}],"outcomes":[{"outcome_type":"primary","measure":"Change from Baseline Depressive Symptomatology at 3 months","time_frame":"Baseline , 3 months","description":"Depressive symptomatology measured with the Patient Health Questionnaire - Nine Item (PHQ-9) at 3 months after patient recruitment."},{"outcome_type":"primary","measure":"Change from Baseline Depressive Symptomatology at 6 months","time_frame":"Baseline, 6 months.","description":"Depressive symptomatology measured with the Patient Health Questionnaire - Nine Item (PHQ-9) at 6 months after patient recruitment."},{"outcome_type":"secondary","measure":"Adherence to depression treatment at patient's level","time_frame":"3 and 6 months after baseline."},{"outcome_type":"secondary","measure":"Change from Baseline Quality of life at 3 and 6 months","time_frame":"Baseline , 3 months, 6 months.","description":"Quality of life at patient's level measured with the Health Survey, Short form (SF-36), at 3 months and 6 months after patient recruitment."},{"outcome_type":"secondary","measure":"Change from Baseline Clinical Outcomes at 3 and 6 months","time_frame":"Baseline , 3 months, 6 months.","description":"Clinical outcomes at patient's level measured with the Outcome Questionnaire-45.2 (OQ-45.2), at 3 months and 6 months after patient recruitment."},{"outcome_type":"secondary","measure":"Use of Health Care services at patient's level","time_frame":"3 and 6 months after baseline","description":"Use of Health Care services at patient's level measured with and ad-hoc built questionnaire."},{"outcome_type":"secondary","measure":"Rate of treated depressed cases at Primary Care team level","time_frame":"12 months before randomization and 12 months after."}]}
{"nct_id":"NCT01916369","start_date":"2014-04-30","phase":"Phase 1","enrollment":5,"brief_title":"Safety Trial Of CTX Cells In Patients With Lower Limb Ischaemia","official_title":"A Phase I Ascending Dose Safety Study Of Intramuscular CTX0E03 In Patients With Lower Limb Ischaemia","primary_completion_date":"2018-01-16","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-01-16","last_update":"2018-01-31","description":"The primary objective of the Phase I ascending dose trial is to investigate the safety and tolerability of intramuscular (gastrocnemius) injections of human neural stem cell product, CTX, in patients with peripheral arterial disease (Fontaine Stage II through IV). This trial is based on independent preclinical data from a leading academic research institution that has been submitted for publication. Inclusion of patients with Fontaine Stage II is justified as these patients have a lower incidence of background events and will facilitate distinction between events which are possibly intervention-related versus spontaneous events associated with underlying advanced atherosclerosis. The trial is designed to treat 9-18 patients and evaluate safety measures over a 12 month follow-up period.","other_id":"RN09-CP-0001","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Signed and dated written informed consent obtained from the patient.\r\n\r\n          -  Peripheral arterial occlusive disease due to atherosclerosis (Fontaine stages II, III\r\n             or IV) of one leg or both defined as\r\n\r\n          -  Fontaine stage II: Intermittent claudication\r\n\r\n          -  Fontaine stage III: Rest pain\r\n\r\n          -  Fontaine stage IV: Ischaemic ulcer or (dry) gangrene\r\n\r\n          -  Patients unsuitable for surgical re-vascularisation\r\n\r\n          -  An ABPI of <0.9 or a toe/brachial index of <0.7\r\n\r\n          -  Age >50 years\r\n\r\n          -  Males or Females. Women must be surgically sterile or more than 2 years post their\r\n             last menstrual period and with a negative pregnancy test.\r\n\r\n          -  Smoker or non-smoker\r\n\r\n          -  Diabetics and non-diabetics provided HbA1c <8% (or 64 mmol/mol)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Estimated survival of less than 6 months.\r\n\r\n          -  Infection of the involved extremity manifested by fever, purulence, or severe\r\n             cellulitis or active wet gangrenous tissue wound with exposed tendon or bone.\r\n\r\n          -  Failed ipsilateral revascularisation procedure within 8 weeks prior to enrolment\r\n             (defined as failure to restore adequate circulation, i.e., the procedure did not\r\n             achieve an increase in ABPI of 0.15 or more, substantial improvement in Pulse Volume\r\n             Recording, or clinical improvement).\r\n\r\n          -  Previous amputation of the talus or above in the target limb.\r\n\r\n          -  Planned major amputation within one month of planned date for injection of study\r\n             medication (CTX DP).\r\n\r\n          -  Anticoagulants including heparin, warfarin or analogues within the past month unless\r\n             these can be discontinued per protocol for seven days prior to injection and two days\r\n             post injection in the case of warfarin or one day prior to injection and two days post\r\n             injection in the case of heparin or other anticoagulants.\r\n\r\n          -  A history of deep vein thrombosis in either leg.\r\n\r\n          -  Previous treatment with systemic growth pro-angiogenic factors or with stem-cell\r\n             therapy.\r\n\r\n          -  Ulcers from venous or neuropathic origin.\r\n\r\n          -  Uncontrolled blood pressure defined as sustained systolic blood pressure 180 mm Hg or\r\n             diastolic blood pressure 110 mm Hg on repeated measures on different days.\r\n\r\n          -  Acute cardiovascular events (e.g., myocardial infarction, stroke, recent coronary\r\n             intervention) up to 6 months prior to enrolment.\r\n\r\n          -  Previous or present history of malignant disease (except basal-cell carcinoma and\r\n             cervical carcinoma in situ, which was removed without recurrence more than 5 years\r\n             prior to enrolment).\r\n\r\n          -  Body mass index >35.\r\n\r\n          -  Previously diagnosed as clinically immune-compromised or taking systemic\r\n             immunosuppressant medication.\r\n\r\n          -  Patients taking sodium valproate for any indication within the past week.\r\n\r\n          -  Organ transplant recipient.\r\n\r\n          -  Inability to comprehend consent information or unlikely to comply with study\r\n             requirements\r\n\r\n          -  Participation in another study involving an Investigational Medicinal Product within\r\n             the 3 months or 5 half-lives of the product (whichever is longer) prior to enrolment.\r\n\r\n          -  Drug or alcohol abuse.\r\n\r\n          -  Any other significant disease or abnormalities likely to impact study compliance or\r\n             interpretation of the results. (If in doubt consult with the ReNeuron study monitor).\r\n\r\n          -  Patients taking tamoxifen or analogues.\r\n      ","sponsor":"ReNeuron Limited","sponsor_type":"Industry","conditions":"Peripheral Arterial Disease","interventions":[{"intervention_type":"Biological","name":"Biological: CTX DP","description":"Single dose treatment consisting of 10 injections (20, 50 or 80 million cells) into the gastrocnemius muscle near to the damaged area"}],"outcomes":[{"outcome_type":"primary","measure":"incidence of adverse events","time_frame":"12 months","description":"Monitoring of medical history, general physical examination, physical examination of the ipsilateral leg (inflammation, infection, swelling, tenderness, ulceration, gangrene), temperature, pulse rate and rhythm, ECG, blood pressure, full blood count, liver function tests, serum urea and electrolytes, creatine phosphokinase(muscle isoform), immunological response to CTX, amputation and concomitant medication."}]}
{"nct_id":"NCT03292549","start_date":"2014-04-30","enrollment":452,"brief_title":"RObotic PArtial Nephrectomy National Study","official_title":"RObotic PArtial Nephrectomy National Study (RoPaN Study)","primary_completion_date":"2015-04-30","study_type":"Observational","rec_status":"Completed","completion_date":"2016-04-30","last_update":"2017-09-25","description":"The purpose of the study is to set up the larger prospective study on robotic partial nephrectomy, to describe the characteristics of patients operated for kidney cancer by this surgical procedure and also to determine the modalities of hemostasis in this procedure.","other_id":"CHUBX 2012/30","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients operated for kidney cancer by this surgical procedure","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subject is at least 18 years old at the time of screening\r\n\r\n          -  Subject has been diagnosed with renal tumor(s)\r\n\r\n          -  Subject will undergo a robot assisted partial nephrectomy\r\n\r\n          -  Subject is willing and able to comply with the requirements of the protocol\r\n\r\n        Exclusion Criteria: None\r\n      ","sponsor":"University Hospital, Bordeaux","sponsor_type":"Other","conditions":"Kidney Cancer","interventions":[{"intervention_type":"Procedure","name":"Procedure: Robotic partial surgery","description":"Robotic partial surgery"}],"outcomes":[{"outcome_type":"primary","measure":"Post-operative complications evaluated according to the Clavien criteria","time_frame":"From surgery until 1 year of follow up","description":"Per and post-operative transfusion rates"},{"outcome_type":"primary","measure":"Post-operative complications evaluated according to the Clavien criteria","time_frame":"From surgery until 1 year of follow up","description":"Medical or surgical complication rates"},{"outcome_type":"primary","measure":"Post-operative complications evaluated according to the Clavien criteria","time_frame":"From surgery until 1 year of follow up","description":"Clavien's grading"},{"outcome_type":"primary","measure":"Post-operative complications evaluated according to the Clavien criteria","time_frame":"From surgery until 1 year of follow up","description":"Urinary fistula rate"},{"outcome_type":"primary","measure":"Post-operative complications evaluated according to the Clavien criteria","time_frame":"From surgery until 1 year of follow up","description":"Necessity for nephrectomy or re-exploration"},{"outcome_type":"primary","measure":"Post-operative complications evaluated according to the Clavien criteria","time_frame":"From surgery until 1 year of follow up","description":"Length of hospital stay"},{"outcome_type":"secondary","measure":"Renal function after robotic partial nephrectomy measured by biological parameters","time_frame":"Follow-up during 12 months","description":"Creatininemia"},{"outcome_type":"secondary","measure":"Renal function after robotic partial nephrectomy measured by biological parameters","time_frame":"Follow-up during 12 months","description":"MDRD GFR"},{"outcome_type":"secondary","measure":"Per-operative modalities of haemostasis procedure","time_frame":"At Surgery","description":"Haemostasis procedure"},{"outcome_type":"secondary","measure":"Per-operative modalities of haemostatic agent","time_frame":"At Surgery","description":"Haemostatic agent"}]}
{"nct_id":"NCT02109016","start_date":"2014-04-30","phase":"Phase 2","enrollment":18,"brief_title":"A Study to Assess the Efficacy and Safety of the VEGFR-FGFR Inhibitor, Lucitanib, Given to Patients With Advanced/Metastatic Lung Cancer and FGF, VEGF, or PDGF Related Genetic Alterations","official_title":"A Single Arm, Open-label, Phase 2 Study to Assess the Efficacy and Safety of Lucitanib Given Orally as a Single Agent to Patients With Advanced/Metastatic Lung Cancer and FGF, VEGF, or PDGF Related Genetic Alterations","primary_completion_date":"2016-04-01","study_type":"Interventional","rec_status":"Terminated","completion_date":"2016-09-30","last_update":"2019-07-29","description":"The purpose of this study is to determine whether lucitanib is safe and effective in the treatment of patients with advanced/metastatic lung cancer and fibroblast growth factor (FGF), vascular endothelial growth factor receptor (VEGF), or platelet derived growth factor (PDGF) related genetic alterations.","other_id":"E-3810-II-02","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically or cytologically confirmed advanced/metastatic SCLC or NSCLC\r\n\r\n          -  Any of the following tumor tissue based genetic alterations: FGFR1, FGFR2, FGFR3,\r\n             VEGFA, or PDGFR amplification; Any FGFR1, FGFR2, or FGFR3 gene fusion; FGFR1, FGFR2,\r\n             or FGFR3 activating mutation\r\n\r\n          -  Availability of tumor tissue sample suitable for the central confirmation of the\r\n             genetic alteration and exploratory analyses\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) of 0 or 1\r\n\r\n          -  Measurable disease per RECIST 1.1\r\n\r\n          -  Documented radiographic disease progression following at least one line of therapy in\r\n             the advanced/metastatic setting\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Tumors that are invading a major vessel; NSCLC tumors abutting to a major vessel\r\n\r\n          -  Uncontrolled hypertension, defined as SBP  140 mmHg and/or DBP  90 mmHg with\r\n             optimized anti-hypertensive therapy\r\n\r\n          -  Uncontrolled hypothyroidism defined as serum thyroid stimulating hormone (TSH) higher\r\n             than 5 mIU/mL while receiving appropriate thyroid hormone therapy\r\n\r\n          -  Symptomatic and/or untreated central nervous system metastases\r\n\r\n          -  Presence of another active cancer\r\n\r\n          -  Ongoing adverse events from surgery or prior anti-cancer therapies, including\r\n             radiation, targeted, or cytotoxic therapies\r\n\r\n          -  Pregnant or breastfeeding women\r\n      ","sponsor":"Clovis Oncology, Inc.","sponsor_type":"Industry","conditions":"Non-Small Cell Lung Cancer|Squamous Non-Small Cell Lung Cancer|NSCLC|Small Cell Lung Cancer|SCLC|Lung Cancer|Advanced Lung Cancer|Metastatic Lung Cancer|Stage IV Lung Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Lucitanib","description":"Lucitanib given orally to all patients, once daily (q.d.), on a continuous schedule over 28-day cycles, in fasting conditions (at least 2 hours prior to and 2 hours after any meal), until progressive disease or unacceptable toxicity.\r\nStarting dose is 10 mg/day and can be reduced in 2.5 mg decrements to 5 mg/day based on individual tolerability."}],"outcomes":[{"outcome_type":"primary","measure":"Objective Response Rate (ORR)","time_frame":"Screening, every 8 weeks; up to 2 years","description":"Proportion of patients in whom a confirmed Complete Response (CR) or a confirmed Partial Response (PR), as best overall response according to RECIST criteria, is observed."},{"outcome_type":"secondary","measure":"Clinical Benefit Rate (CBR)","time_frame":"Screening, every 8 weeks; up to 2 years","description":"Proportion of patients in whom a confirmed CR or confirmed PR or a prolonged Stable Disease (SD) (≥ 6 months), as best overall response according to RECIST, is observed"},{"outcome_type":"secondary","measure":"Progression-Free Survival (PFS)","time_frame":"Screening, every 8 weeks; up to 2 years","description":"Time from the date of first drug intake until the date of progression or death for any cause"},{"outcome_type":"secondary","measure":"Duration of response (DOR)","time_frame":"Screening, every 8 weeks; up to 2 years","description":"For responders (i.e. patients with best overall response CR or PR), the interval from the time of first documentation of response to the date of progression or death for any cause"},{"outcome_type":"secondary","measure":"Duration of clinical benefit","time_frame":"Screening, every 8 weeks; up to 2 years","description":"For responders and patients with SD as best overall response, time from the first drug intake until the date of progression or death for any cause"},{"outcome_type":"secondary","measure":"Overall Survival (OS)","time_frame":"Continuously; up to 2 years","description":"From the date of first drug intake to the date of death for any cause"},{"outcome_type":"secondary","measure":"Tumor growth kinetics","time_frame":"Screening, every 8 weeks; up to 2 years","description":"Will be evaluated using the following criteria: tumor size; tumor volume; tumor growth"},{"outcome_type":"secondary","measure":"Incidence of adverse events (AEs), clinical laboratory abnormalities, and dose modifications","time_frame":"Continuously; up to 2 years"},{"outcome_type":"secondary","measure":"PK parameters of lucitanib","time_frame":"Cycle 1 Day 14 and 28, Cycle 2 Day 28, Cycle 3 Day 28"},{"outcome_type":"secondary","measure":"Pharmacogenomic analysis of inter-patients variation in gene encoding ADME involved proteins","time_frame":"Cycle 1 Day 1"},{"outcome_type":"secondary","measure":"Pharmacodynamic (PD) evaluation of lucitanib profile","time_frame":"Cycle 1 Day 1 and 14, End of Study","description":"Soluble growth factors and other biomarkers, including circulating tumor DNA"}]}
{"nct_id":"NCT02209454","start_date":"2014-04-30","phase":"Phase 1","enrollment":26,"brief_title":"Comparative Bioavailability of Dexketoprofen Trometamol Oral Solution vs Tablet Formulations","official_title":"Comparative Study of the Bioavailability of Dexketoprofen Trometamol Following Single Doses of 25mg Enantyum Oral Solution vs. Keral Tablets in Healthy Subjects","primary_completion_date":"2014-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-06-30","last_update":"2015-07-09","description":"The purpose of this study is to compare the bioavailability of 25 mg DKP.TRIS given as an Enantyum oral solution (Test formulation) and Keral tablet (Reference formulation). In addition, this study intends to evaluate the safety and tolerability of Test and Reference formulations.","other_id":"RD 303/25652(DKP-BE-SOL)","allocation":"Randomized","intervention_model":"Crossover Assignment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        - Healthy male and female subjects between 18 to 50 years old, with a Body Mass Index (BMI)\r\n        between 18 Kg/m2 and 28 Kg/m2-\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of previous allergy idiosyncrasy / sensitivity to DKP.TRIS or other NSAIDs\r\n             (aspirin, ibuprofen etc).\r\n\r\n          -  Any condition which might interfere with the absorption, distribution, metabolism or\r\n             excretion of the drugs.\r\n\r\n          -  Surgery within previous 6 months, or blood loss > 400 mL within previous 3 months.\r\n\r\n          -  Subject with positive human immunodeficiency virus (HIV), hepatitis B surface antigen\r\n             (Hep B) and hepatitis C virus antibody (Hep C) results.\r\n\r\n          -  History of clinically significant alcohol, medicine or drug abuse.\r\n      ","sponsor":"Menarini Group","sponsor_type":"Industry","conditions":"Acute Pain","interventions":[{"intervention_type":"Drug","name":"Drug: Enantyum oral solution","description":"One dose of 25 mg DKP oral solution"},{"intervention_type":"Drug","name":"Drug: Keral tablet","description":"One dose of 25 mg DKP tablet"}],"outcomes":[{"outcome_type":"primary","measure":"Cmax","time_frame":"Up to 24h post-dose (pre-dose, T+5', T+10', T+15', T+20', T+30', T+40', T+50', T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).","description":"The absence of any difference in the rate and extent of absorption will be demonstrated if the 90% CI for the geometric mean ratio between Test and Reference formulations is within the range 80.00% - 133.00% for Cmax."},{"outcome_type":"primary","measure":"AUC(0-t)","time_frame":"Up to 24h post-dose (pre-dose, T+5', T+10', T+15', T+20', T+30', T+40', T+50', T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).","description":"The absence of any difference in the rate and extent of absorption will be demonstrated if the 90% CI for the geometric mean ratio between Test and Reference formulations is within the range 80.00% - 125.00% for AUC(0-t)."},{"outcome_type":"secondary","measure":"AUC(0-∞)","time_frame":"Up to 24h post-dose (pre-dose, T+5', T+10', T+15', T+20', T+30', T+40', T+50', T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).","description":"AUC(0-∞) will be analysed similarly to AUC(0-t) and Cmax. Time to achieve maximum plasma concentration (tmax) and t1/2 will be summarized descriptively."},{"outcome_type":"secondary","measure":"Tmax","time_frame":"Up to 24h post-dose (pre-dose, T+5', T+10', T+15', T+20', T+30', T+40', T+50', T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).","description":"AUC(0-∞) will be analysed similarly to AUC(0-t) and Cmax. Time to achieve maximum plasma concentration (tmax)."},{"outcome_type":"secondary","measure":"t1/2","time_frame":"Up to 24h post-dose (pre-dose, T+5', T+10', T+15', T+20', T+30', T+40', T+50', T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).","description":"AUC(0-∞) will be analysed similarly to AUC(0-t) and Cmax. Time to achieve maximum plasma concentration (tmax) and t1/2 will be summarized descriptively."}]}
{"nct_id":"NCT02819362","start_date":"2014-04-30","enrollment":106,"brief_title":"Benefit of a Diagnostic MRI in Case of Pathological Nipple Discharge With Normal Mammography / Ultrasound","official_title":"Benefit of a Diagnostic MRI in Case of Pathological Nipple Discharge With Normal Mammography / Ultrasound.","primary_completion_date":"2018-04-30","study_type":"Observational","rec_status":"Unknown status","completion_date":"2018-04-30","last_update":"2017-11-21","description":"Benefit of MRI in pathological nipple discharge.","other_id":"IB2013-IRM","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"Female","minimum_age":18,"population":"Patients with pathological nipple discharge","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Single pore nipple discharge neither green nor milky.\r\n\r\n          2. Mammography (at least 2 shots, +/- centred on retro-areal) normal.\r\n\r\n          3. Initial ultrasound: normal.\r\n\r\n          4. Age over 18 years\r\n\r\n          5. Female\r\n\r\n          6. Patient affiliated to the social security scheme.\r\n\r\n          7. Patient information and informed consent signed and dated\r\n\r\n        Exclusion Criteria:\r\n\r\n        Physiological milky or green discharge\r\n      ","sponsor":"Institut Bergoni","sponsor_type":"Other","conditions":"Breast Cancer","interventions":[{"intervention_type":"Device","name":"Device: MRI","description":"The magnetic resonance imaging (MRI) will be performed before the two-step surgery: a ductal-MRI sequence (highly weighted sagittal T2) - followed by sequence with axial plane, T2, T1, injection in dynamic sequences, subtractions."}],"outcomes":[{"outcome_type":"primary","measure":"The negative predictive value (NPV) of MRI in patients with pathological nipple discharge with normal mammography / ultrasound.","time_frame":"At baseline"},{"outcome_type":"secondary","measure":"Diagnostic performances of MRI (sensitivity, specificity, positive predictive value) in pathological nipple discharge with normal mammography / ultrasound.","time_frame":"At baseline"}]}
{"nct_id":"NCT02906228","start_date":"2014-04-01","phase":"N/A","enrollment":30,"brief_title":"Radiofrequency Electromagnetic Field (RF-EMF) Effects on Brain Activity During Sleep and Waking in Healthy Elderly Women","official_title":"Einfluss Hochfrequenter Elektromagnetischer Felder Auf Gehirnaktivitt, Schlaf Und Kognitive Leistungsfhigkeit lterer Frauen","primary_completion_date":"2016-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-07-31","last_update":"2021-02-10","description":"The purpose of this study is to investigate possible effects of radio frequency electromagnetic fields on EEG activity during sleep and on Brain function during wake (EEG in the resting state condition, slow EEG potentials, auditory evoked potentials) and cognitive performance measures in test of selective attention, divided attention and working memory in healthy elderly females (60 - 80 years).","other_id":"3614S30012","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Basic Science","masking_description":"Triple","sampling_method":"","gender":"Female","minimum_age":60,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  healthy male subjects (age 60 - 80 years) right handedness alpha EEG as resting state\r\n             EEG\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  acute illness severe neurological, psychiatric or internal disease CNS active\r\n             medication sleep disorders drug abuse\r\n      ","sponsor":"The Federal Office for Radiation Protection, Germany","sponsor_type":"Other","conditions":"Nervous System Effects","interventions":[{"intervention_type":"Radiation","name":"Radiation: Exposure within the given regulatory limits for non-ionizing electromagnetic fields according to ICNIRP guidelines and German law"}],"outcomes":[{"outcome_type":"primary","measure":"sleep assessed by EEG power","time_frame":"during 8 h exposure"},{"outcome_type":"secondary","measure":"restin g state waking EEG (Power)","time_frame":"during exposure 4 h"}]}
{"nct_id":"NCT02060149","start_date":"2014-03-31","phase":"Phase 1/Phase 2","enrollment":90,"brief_title":"The Effect of Nebulization of Alkaline Solution on Treating XDRAB Pneumonia With C/S Plus Minocycline","official_title":"The Effect of Nebulization of Alkaline Solution on Treating Extensively Drug Resistant A. Baumannii Pneumonia With Cefoperazone and Sulbactam Plus Minocycline: A Multi-center Randomized Study","primary_completion_date":"2015-03-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2015-04-30","last_update":"2014-02-11","description":"The mortality of pneumonia with extensively drug resistant Acinetobacter baumannii (XDRAB) is still high, even if these patients received certain strong anti-infection treatment such us the combination of cefoperazone-sulbactam (C/S) and minocycline. Health airway lining fluid is mildly alkaline but airway acidification usually appears for the infection of XDRAB. The hypothesis is offered that the biologic activity of XDRAB might be inhibited if the circumstance including pH is changed. In the vitro study we observed that the inhibit effect of antibiotics on XDRAB growth was improved significantly by alkaline solution within the scope of physiology. So the aim of this clinical study is to explore the effects of nebulization of alkaline Solution on C/S plus minocycline on the pneumonia with XDRAB.","other_id":"xjhx-song1","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age: 18 to 75 years old, male or female\r\n\r\n          -  The pneumonia patients met the diagnostic criteria, and clinical pulmonary infection\r\n             score (CPIS)  5;\r\n\r\n          -  The sputum bacteriology detection only prompted Acinetobacter baumannii culture for\r\n             pathogens concentration meets the diagnostic criteria of the Chinese hospital-acquired\r\n             pneumonia diagnosis and treatment guidelines, 2002 edition of \"Acinetobacter baumannii\r\n             and susceptibility results show only 1 to 2 sensitive to antimicrobial drugs\r\n             (polymyxin, minocycline or tegafur doxycycline);\r\n\r\n          -  Cephalosporins or tetracyclines drug treatment without a history of allergies and\r\n             contraindications;\r\n\r\n          -  Be able to accept inhalation therapy.\r\n\r\n          -  Informed consent gained\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Refused to accept inhalation therapy\r\n\r\n          -  Renal insufficiency, creatinine clearance (Cockcroft-Gault formula) (CLcr) 15 ml / min\r\n             or less;\r\n\r\n          -  Liver dysfunction, defined as Child-Pugh score B or C\r\n\r\n          -  Within one week before the start of cefoperazone sulbactam, minocycline treatment.\r\n      ","sponsor":"Xijing Hospital","sponsor_type":"Other","conditions":"Pneumonia","interventions":[{"intervention_type":"Drug","name":"Drug: C/S plus minocycline.","description":"Cefoperazone/ sulbactam 3.0gintravenous infusion, q8h or q6h) combined with minocycline doxycycline 100mg (oral, q12h)."},{"intervention_type":"Drug","name":"Drug: nebulization with pH 7.4 solution","description":"Patients will receive the nebulization with Sodium Bicarbonate of pH 7.4 (Each time the volume of aerosol solution is 5ml, q8h)."},{"intervention_type":"Drug","name":"Drug: nebulization with pH 7.8 solution","description":"Patients will receive the nebulization with Sodium Bicarbonate of pH 7.8 (Each time the volume of aerosol solution is 5ml, q8h)."},{"intervention_type":"Drug","name":"Drug: No nebulization","description":"No nebulization will be given to the patients."}],"outcomes":[{"outcome_type":"primary","measure":"Pathogenic Clearance rate and recovery rate","time_frame":"one treatment course for about two weeks"},{"outcome_type":"secondary","measure":"adverse reaction rate","time_frame":"one treatment course for about two weeks"},{"outcome_type":"other","measure":"hospital time and mortality","time_frame":"about four weeks"}]}
{"nct_id":"NCT02091882","start_date":"2014-03-31","phase":"Phase 4","enrollment":30,"brief_title":"Substudy of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)","official_title":"OSMITTER 316-13-206A Substudy: A Substudy to Measure the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1) System and Determine the Latency Period","primary_completion_date":"2014-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-05-31","last_update":"2015-04-15","description":"The purpose of this study is to determine the accuracy of IEM detection by the MIND1 System by completing a series of Patch applications and IEM ingestions in the clinic.","other_id":"316-13-206A","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy males or healthy non-pregnant females 18 to 65 years of age at the time of\r\n             informed consent who are willing to either practice abstinence or 2 barrier methods of\r\n             birth control or 1 barrier method and an oral contraceptive method\r\n\r\n          -  Subject must be in good general health (not suffering from a serious chronic mental or\r\n             physical disorder that has required or may in the near future require urgent medical\r\n             care)\r\n\r\n          -  Body mass index between 19 to 32 kg/m2 (inclusive)\r\n\r\n          -  Ability to eat the high fat meal\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subject with a history of skin sensitivity to adhesive medical tape or metals.\r\n\r\n          -  Subject who, in the opinion of the investigator, is acutely psychotic or manic and has\r\n             symptoms currently requiring hospitalization\r\n\r\n          -  Subject with a history or evidence of a medical condition that would expose him or her\r\n             to an undue risk of a significant adverse event (AE) or interfere with assessments of\r\n             safety during the course of the trial\r\n\r\n          -  Subject has received any investigational product within the last 30 days.\r\n\r\n          -  Subject has a current history of drug or alcohol dependence that meets Diagnostic and\r\n             Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)\r\n             criteria\r\n\r\n          -  Subject has the presence of cognitive impairment\r\n\r\n          -  Subject currently taking antipsychotic medication Subject with a terminal illness\r\n\r\n          -  Subject with a history of chronic dermatitis\r\n\r\n          -  Subject with a history of gastrointestinal surgery that could impair absorption\r\n\r\n          -  Female subject who is breastfeeding and/or who has a positive serum pregnancy test\r\n             result prior to receiving trial medications\r\n\r\n          -  Sexually active women of childbearing potential (WOCBP) who will not commit to using 2\r\n             forms of approved birth control methods or who will not remain abstinent during this\r\n             trial and for 30 days following the last dose of trial medication\r\n\r\n          -  Sexually active males who will not commit to using 2 of the approved birth control\r\n             methods or who will not remain abstinent for the duration of the trial and for 90 days\r\n             following the last dose of trial medication\r\n\r\n          -  No permanent physical residence\r\n\r\n          -  After resting for  3 minutes, have a sitting systolic blood pressure < 100 or  150\r\n             mmHg and/or diastolic blood pressure < 50 or  90 mmHg\r\n\r\n          -  After resting for  3 minutes, have a sitting pulse rate < 35 or > 100 beats per\r\n             minute\r\n\r\n          -  Any subject who, in the opinion of the investigator, should not participate in the\r\n             trial\r\n      ","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","sponsor_type":"Industry","conditions":"To Determine the Accuracy of IEM Detection by the MIND1 System by Completing a Series of Patch Applications and IEM Ingestions.","interventions":[{"intervention_type":"Device","name":"Device: MIND1 System","description":"Following placement of the Patch by clinic staff, subjects will ingest one IEM tablet approximately every 2 hours, for a total of 4 ingestions. The subject will ingest one 10 mg aripiprazole-embedded IEM tablet without food (Hour 0), one placebo-embedded IEM tablet without food (approximately Hour 2), one placebo-embedded IEM tablet with a high fat meal (approximately Hour 4), and one placebo-embedded IEM tablet without food (approximately Hour 6). Aripiprazole-embedded IEM tablets are being tested along with the placebo-embedded IEM tables to assess any differences in accuracy of IEM detection and latency. The time of ingestion will be recorded by clinic staff, and the time of IEM detection by the MIND1 System phone will be evaluated to determine the period of latency."}],"outcomes":[{"outcome_type":"primary","measure":"The accuracy of IEM detection by the MIND1 Sustem for both aripiprazole and placebo, as measured by the proportion of subjects with IEM activated during the study.","time_frame":"Day 1 Visit"},{"outcome_type":"secondary","measure":"The latency period for both Aripiprazole and placebo between ingestion and detection by the MIND1 System phone.","time_frame":"Day 1 Visit"}]}
{"nct_id":"NCT02311426","start_date":"2014-03-31","enrollment":1000,"brief_title":"Stroke in North of Norway and Denmark. A Prospective Cohort Study.","primary_completion_date":"2016-09-30","study_type":"Observational [Patient Registry]","rec_status":"Unknown status","last_update":"2014-12-08","description":"The study is a comparative effectiveness study with comparision of two cohorts of patients with stroke in North of Norway and in Denmark. At baseline information is collected from the stroke registries in both countries. Time points for follow up are at 3 and 12 months post-stroke. Data are collected from medical charts and with use of telephone interview in addition to self-report questionnaires. The study will provide information about mortality, functional status and quality of life. Information about rehabilitation services in both countries are collected and compared, and analysed in relation to patients outcome.","other_id":"SFP1175-14","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"Patients with stroke admitted to the stroke units at the University Hospital of North\r\n        Norway and rhus Hospital in Denmark","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Verified stroke. Admitted to stroke unit.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients outside the regions included.\r\n      ","sponsor":"University Hospital of North Norway","sponsor_type":"Other","conditions":"Stroke","interventions":[{"intervention_type":"Other","name":"Other: Observational study"}],"outcomes":[{"outcome_type":"primary","measure":"Modified Rankin Scale","time_frame":"12 months"},{"outcome_type":"primary","measure":"Quality of life questionnaire","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Mortality","time_frame":"3 months"}]}
{"nct_id":"NCT02446496","start_date":"2014-03-31","phase":"Phase 4","enrollment":24,"brief_title":"A Bioequivalence Study of Cefadroxil Film Coated Tablets After A Single Oral Dose Administration to Healthy Subjects","official_title":"Comparative Randomized, Single Dose, Two-way Crossover, Open-label Study to Determine the Bioequivalence of Cefadroxil From Duricef 1 gm Film Coated Tablets (Smithkline Beecham Egypt, LLC Affiliated Co. to GalaxoSmithKline ) and Biodroxil 1 gm Film Coated Tablets (Kahira Pharm &Chem .Ind. Co. for Novartis Pharma ) After a Single Oral Dose Administration of Each to Healthy Adults Under Fasting Conditions","primary_completion_date":"2014-04-08","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-04-08","last_update":"2017-09-21","description":"This is an open-label, randomized, single dose, two-sequence two-period crossover study, separated by 7 days washout interval from the first Study Drug Administration. This study is conducted to determine the bioequivalence of cefadroxil from DURICEF film coated tablets manufactured by Smithkline Beecham Egypt, LLC affiliated co. to GalaxoSmithKline (GSK) and cefadroxil from BIODROXIL film coated tablets manufactured by Kahira Pharm &amp;Chem .Ind. Co . for Novartis Pharma (NP) after a single oral dose administration of each to healthy adult subjects under fasting conditions. In Period 1, subjects will be randomized to receive cefadroxil tablet manufactured by either GSK or NP. Following a washout of at least 7 days, subjects will be crossed over in Period 2 to receive the cefadroxil tablet that they did not receive in Period 1. DURICEF is a trademark of the GSK group of companies. BIODROXIL is a trademark of Sandoz.","other_id":"201529","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy male or female, age 18 to 55 years, inclusive.\r\n\r\n          -  Body weight within 15 percent of normal range according to the accepted normal values\r\n             for body mass index (BMI).\r\n\r\n          -  Medical demographics without evidence of clinically significant deviation from normal\r\n             medical condition.\r\n\r\n          -  Results of clinical laboratory test are within the normal range or with a deviation\r\n             that is not considered clinically significant by principal investigator.\r\n\r\n          -  Subject does not have allergy to the drugs under investigation.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subjects with known allergy to the products tested.\r\n\r\n          -  Subjects whose values of BMI were outside the accepted normal ranges.\r\n\r\n          -  Female subjects who were pregnant, nursing or taking birth control pills.\r\n\r\n          -  Medical demographics with evidence of clinically significant deviation from normal\r\n             medical condition.\r\n\r\n          -  Results of laboratory tests which are clinically significant.\r\n\r\n          -  Acute infection within one week preceding first study drug administration.\r\n\r\n          -  History of drug or alcohol abuse.\r\n\r\n          -  Subject does not agree not to take any prescription or non-prescription drugs within\r\n             two weeks before first study drug administration and until the end of the study.\r\n\r\n          -  Subject is on a special diet (for example subject is vegetarian).\r\n\r\n          -  Subject does not agree not to consume any beverages or foods containing\r\n             methyl-xanthenes e.g. caffeine (coffee, tea, cola, chocolate etc.) 48 hours prior to\r\n             the study administration of either study period until donating the last sample in each\r\n             respective period.\r\n\r\n          -  Subject does not agree not to consume any beverages or foods containing grapefruit 7\r\n             days prior to first study drug administration until the end of the study.\r\n\r\n          -  Subject has a history of severe diseases which have direct impact on the study.\r\n\r\n          -  Participation in a bioequivalence study or in a clinical study within the last 6 weeks\r\n             before first study drug administration.\r\n\r\n          -  Subject intends to be hospitalized within 6 weeks after first study drug\r\n             administration.\r\n\r\n          -  Subjects who, through completion of this study, would have donated more than 500\r\n             milliliter (mL) of blood in 7 days, or 750 mL of blood in 30 days, 1000 mL in 90 days,\r\n             1250 mL in 120 days, 1500 mL in 180 days, 2000 mL in 270 days, 2500 mL of blood in 1\r\n             year.\r\n      ","sponsor":"GlaxoSmithKline","sponsor_type":"Industry","conditions":"Infections, Urinary Tract","interventions":[{"intervention_type":"Drug","name":"Drug: Cefadroxil tablets manufactured by GSK","description":"Cefadroxil tablets manufactured by GSK contains 1 mg of Cefadroxil"},{"intervention_type":"Drug","name":"Drug: Cefadroxil tablets manufactured by NP","description":"Cefadroxil tablets manufactured by NP contains 1 mg of Cefadroxil"}],"outcomes":[{"outcome_type":"secondary","measure":"Apparent First-order Elimination or Terminal Rate Constant (Ke)","time_frame":"Pre-dose (0.00) and 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00 and 12.00 hours post-dose in each treatment period.","description":"Plasma samples for PK analysis were drawn at indicated time points of each treatment period. Apparent first-order elimination or terminal rate constant calculated from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares regression analysis using the last three (or more) non-zero plasma concentrations."},{"outcome_type":"primary","measure":"Maximal Measured Plasma Concentration (Cmax) After a Single Dose","time_frame":"Pre-dose (0.00) and 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00 and 12.00 hours post-dose in each treatment period.","description":"Plasma samples for pharmacokinetic (PK) analysis were drawn at indicated time points of each treatment period. Cmax was defined as maximal measured plasma concentration over the time span specified."},{"outcome_type":"primary","measure":"Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) and Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-infinity)","time_frame":"Pre-dose (0.00) and 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00 and 12.00 hours post-dose in each treatment period.","description":"Plasma samples for PK analysis were drawn at indicated time points of each treatment period. Area under the plasma concentration-time curve from time zero (0) to the last measurable concentration (t), as calculated by the linear trapezoidal method. Area under the plasma concentration-time curve from time zero (0) to infinity (AUC0-infinity) was calculated as the sum of the AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant (Ke), where first-order elimination or terminal rate constant calculated from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares regression analysis using the last three (or more) non-zero plasma concentrations."},{"outcome_type":"secondary","measure":"Time of the Maximum Plasma Concentration (T-max) and Terminal Half- Life (T-half)","time_frame":"Pre-dose (0.00) and 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00 and 12.00 hours post-dose in each treatment period.","description":"Plasma samples for PK analysis were drawn at indicated time points of each treatment period. If the maximum value occurs at more than one point T-max was defined as the first time point with this value. The elimination or terminal half-life was calculated by dividing 0.693 (natural logarithm of 2) with lambda z, where lambda z is the terminal phase rate constant estimated by linear regression analysis of the log transformed concentration-time data after each single dose."}]}
{"nct_id":"NCT02166645","start_date":"2014-03-31","phase":"N/A","enrollment":94,"brief_title":"Comparison Between Preterm Infants Who Are Placed on Their Back or Stomach in the Immediate Postextubation Period","official_title":"Comparison of Prone and Supine Positioning in the Immediate Postextubation Period of Preterm Infants: a Randomized Controlled Trial Protocol","primary_completion_date":"2015-02-28","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2015-02-28","last_update":"2014-06-18","description":"The purpose of this study is to determine whether patient positioning (prone and supine positioning) contributes to the success of extubation in the immediate postextubation period of preterm infants.","other_id":"NCT","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","maximum_age":0.69231,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Newborns less than 37 weeks of gestation age (calculated by doctor using the method of\r\n             Capurro/Ballard)\r\n\r\n          -  Newborns undergone to invasive mechanical ventilation in the first week of life, for\r\n             more than 48 hours\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Newborns who present malformations and clinical or surgical conditions that preclude\r\n             the positioning in prone or supine after extubation\r\n      ","sponsor":"Uniao Metropolitana de Educacao e Cultura","sponsor_type":"Other","conditions":"Pregnancy Preterm","interventions":[{"intervention_type":"Other","name":"Other: Prone position","description":"Participants of intervention group will be placed in prone position immediately after extubation and positioned over a roll to raise the chest and facilitate diaphragmatic dynamic, with lateralized head and aligned with the trunk, upper and lower limbs flexed and hands near the face, facilitating hand-mouth access."},{"intervention_type":"Other","name":"Other: Supine position","description":"Participants of control group remain in supine position after extubation and positioned with the head in the midline, with the upper side of the thorax and brought forward and rolls down the legs to promote slight flexion (30-40) in the hips and knees."}],"outcomes":[{"outcome_type":"primary","measure":"Successful extubation","time_frame":"48 hours after extubation"},{"outcome_type":"secondary","measure":"Improvement of parameters","time_frame":"48 hours after extubation","description":"Improvement of parameters (respiratory rate, heart rate, saturation of peripheral oxygen, fraction of inspired oxygen and temperature)"},{"outcome_type":"other","measure":"Decrease complications of mechanical ventilation","time_frame":"48 hours after extubation"}]}
{"nct_id":"NCT02113579","start_date":"2014-03-31","phase":"N/A","enrollment":375,"brief_title":"Test on a New Experimental Mouth Rinse for Relieving Tooth Sensitivity","official_title":"Assessment of a Potassium Oxalate Containing Formulation for the Relief of Dentinal Hypersensitivity","primary_completion_date":"2014-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-05-31","last_update":"2015-06-10","description":"This study is for people with sensitive teeth and involves going to the dentist for 4 visits over 6 weeks. At each visit the dentist will look at the mouth, teeth, tongue and gums of participants, and check for sensitive teeth. During the first 2 weeks, participants will brush their teeth 2 times a day with the fluoride toothpaste provided. Then, if they qualify to continue in the study, participants will be assigned to one of two treatment groups for the last 4 weeks. Both groups will use assigned toothpaste currently sold on the market. Both groups will each have an investigative mouth rinse to use as well. Participants will have an equal chance of being assigned to any one of the three groups. For the next 4 weeks, participants will use their assigned products according to the directions provided. At Visit 1, participants will be supervised while they brush their teeth to ensure they understand the directions. They will also have supervised use of the products at Visit 2. Results will be analyzed to assess whether the mouthwashes help to reduce tooth sensitivity during the study.","other_id":"KOXDHY0009","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Males and females at least 18 years of age in good general and oral health without any\r\n             known allergy to commercial dental products or cosmetics.\r\n\r\n          -  Evidence of a personally signed and dated informed consent document indicating the\r\n             subject (or legally acceptable representative) has been informed of all pertinent\r\n             aspects of the study\r\n\r\n          -  Females of childbearing potential must be using a medically-acceptable method of birth\r\n             control for at least one month prior to Visit 1 and agree to continue using this\r\n             method during their participation in the study. Acceptable methods for this study\r\n             include:\r\n\r\n          -  Abstinence\r\n\r\n          -  Birth control pills, patches, vaginal rings, implants or injections\r\n\r\n          -  Intrauterine device\r\n\r\n          -  Double barrier method (condom/diaphragm or cervical cap with spermicide)\r\n\r\n          -  Bilateral tubal ligation\r\n\r\n          -  Hysterectomy\r\n\r\n          -  Ovariectomy\r\n\r\n          -  Male partner vasectomy\r\n\r\n          -  Willingness to use the assigned products according to instructions, availability for\r\n             appointments, and likelihood of completing the clinical study.\r\n\r\n          -  A minimum of 2 natural premolars, canines, and/or incisors teeth with decay-free\r\n             scorable facial/buccal surfaces which must present cervical abrasion, and/or erosion\r\n             and/or gingival recession.\r\n\r\n          -  A minimum of two eligible teeth (premolars, canines and/or incisors) with a Screening\r\n             (-2 weeks Baseline) and Baseline cold air stimulus Visual Analogue Scale (VAS) score\r\n             of 40 - 80 mm on a 100 mm VAS scale, tactile sensitivity score between 10 - 30 grams\r\n             after application of the Yeaple probe and a tactile (Yeaple probe) VAS of 40 -80 mm on\r\n             a 100 mm VAS scale.\r\n\r\n          -  No more than two eligible teeth per quadrant each separated by 2 other teeth must be\r\n             selected.\r\n\r\n          -  Absence of significant oral soft tissue pathology, based on the dentist's visual\r\n             examination and at the discretion of the investigator.\r\n\r\n          -  Adequate oral hygiene (i.e. brush teeth daily and exhibit no signs of oral neglect).\r\n\r\n          -  Absence of severe marginal gingivitis, moderate/advanced periodontitis (ADA Type III,\r\n             IV) based on a clinical examination and discretion of the Investigator.\r\n\r\n          -  Absence of extensive absence of extensive calculus above the gum line.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Volunteers who report history or presence of kidney disorders, kidney stones, have\r\n             celiac disease, inflammatory bowel disease (ulcerative colitis or Crohn's disease),\r\n             chronic pancreatitis, have had intestinal or weight-loss surgery, or if have stomach\r\n             or intestinal problems that keep them from absorbing certain foods or nutrients.\r\n\r\n          -  Volunteers with eating disorders, uncontrolled Gastroesophageal reflux disease GERD or\r\n             Acid Reflux, excessive dietary or environmental exposure to acids, or other systemic\r\n             conditions that are predisposing to dentinal hypersensitivity.\r\n\r\n          -  Volunteers with chronic medical debilitating disease associated with constant or\r\n             intermittent episodes of daily pain.\r\n\r\n          -  Long-term daily use ( 7 consecutive days) of analgesics and any other drugs that at\r\n             the discretion of the Investigator would compromise the response of the\r\n             hypersensitivity assessments.\r\n\r\n          -  Volunteers who have been using any home-care bleaching, whitening products or have had\r\n             a professional bleaching treatment within 4 weeks of the Screening visit.\r\n\r\n          -  Use of desensitizing agents whether prescribed or over-the-counter within eight weeks\r\n             prior to screening visit (any sensitivity toothpastes such as Crest Sensitivity,\r\n             Sensodyne, Crest Pro-Health, Colgate Sensitivity Relief, any mouthwash and oral care\r\n             products used for the treatment of dentinal hypersensitivity).\r\n\r\n          -  Volunteers who during the study will receive dental treatment which may affect their\r\n             dentinal hypersensitivity condition (i.e., oral prophylaxis). Emergency treatment will\r\n             be allowed.\r\n\r\n          -  Those with a known allergy to study products' ingredients.\r\n\r\n          -  Those requiring antibiotic premedication prior to invasive dental procedures.\r\n\r\n          -  Participation in a dental clinical study involving oral care products within the past\r\n             30 days.\r\n\r\n          -  Self reported pregnancy or lactation (this criterion is due to oral tissue changes\r\n             related to pregnancy and nursing which can affect interpretation of study results)\r\n\r\n          -  Teeth that are grossly carious, orthodontically banded, abutment teeth for fixed or\r\n             removable prostheses, crowned teeth, or third molars will not be included in the\r\n             study.\r\n\r\n          -  Periodontal surgery and orthodontic treatment within previous 3 months.\r\n\r\n          -  Extensive restorative treatment (i.e. extensively restored teeth or teeth with\r\n             restoration(s) extending into the test area) at the discretion of the Investigator.\r\n\r\n          -  Dental prophylaxis within 2 weeks prior to Screening visit.\r\n\r\n          -  Teeth or periodontium with pathology or defect likely to cause pain.\r\n\r\n          -  Teeth with clinical mobility > grade 1.\r\n\r\n          -  Relative, partner or staff of any clinical research site personnel\r\n\r\n          -  Participation in any clinical study within 30 days of Visit 1.\r\n      ","sponsor":"Johnson & Johnson Consumer and Personal Products Worldwide","sponsor_type":"Industry","conditions":"Dentin Sensitivity","interventions":[{"intervention_type":"Device","name":"Device: Experimental Mouth Rinse 12027-033","description":"After brushing for at least one-minute using at least one-inch strip of toothpaste, rinse with water and then rinse 60 seconds with 10mL of mouth rinse, twice daily."},{"intervention_type":"Other","name":"Other: Placebo Mouth Rinse","description":"After brushing for at least one-minute using at least one-inch strip of toothpaste, rinse with water and then rinse 60 seconds with 10mL of mouth rinse, twice daily."}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of Subjects With Reduction From Baseline by at Least 30% in Mean Cold Air VAS Stimulus Score at Week 4","time_frame":"4 Weeks","description":"Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant. A participant was considered an individual success if the participant's mean cold air stimulus VAS score at Week 4 was at least 30% lower than the participant's mean baseline cold air stimulus VAS score."},{"outcome_type":"secondary","measure":"Mean Cold Air Stimulus VAS Score at Week 4","time_frame":"4 Weeks","description":"Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant."},{"outcome_type":"secondary","measure":"Mean Tactile Sensitivity Score at Week 4","time_frame":"4 Weeks","description":"Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit."},{"outcome_type":"secondary","measure":"Mean Cold Air Stimulus VAS Score at Week 2","time_frame":"2 Weeks","description":"Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant."},{"outcome_type":"secondary","measure":"Mean Tactile Sensitivity Score at Week 2","time_frame":"2 Weeks","description":"Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit."},{"outcome_type":"secondary","measure":"Percentage of Subjects With Reduction From Baseline by at Least 30% in Mean Cold Air VAS Stimulus Score at Week 2","time_frame":"2 Weeks","description":"Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant. A participant was considered an individual success if the participant's mean cold air stimulus VAS score at Week 2 was at least 30% lower than the participant's mean baseline cold air stimulus VAS score."},{"outcome_type":"secondary","measure":"Mean Tactile Sensitivity VAS Score at Week 2","time_frame":"2 Weeks","description":"Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant."},{"outcome_type":"secondary","measure":"Mean Tactile Sensitivity VAS Score at Week 4","time_frame":"4 Weeks","description":"Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant."},{"outcome_type":"secondary","measure":"Global Subjective VAS Score at Week 2","time_frame":"2 Weeks","description":"At each visit, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows:\"Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that elicit your dentinal hypersensitivity pain/discomfort since you have been using the product.\" The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm."},{"outcome_type":"secondary","measure":"Global Subjective VAS Score at Week 4","time_frame":"4 Weeks","description":"At each visit, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows:\"Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that elicit your dentinal hypersensitivity pain/discomfort since you have been using the product.\" The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm."}]}
{"nct_id":"NCT02090374","start_date":"2014-03-31","phase":"N/A","enrollment":112,"brief_title":"Development of Human Nasal Challenge Models With Microbial Constituents and Grass Pollen","official_title":"Development of Human Nasal Challenge Models With Microbial Constituents and Grass Pollen: Monophosphoryl lipidA, Poly-inosine-cytosine, Poly-inosine-cytosine Stabilised With Poly-L-lysine and Carboxymethylcellulose, Resiquimod, Tuberculin and Timothy Grass Pollen","primary_completion_date":"2017-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-03-31","last_update":"2017-07-02","description":"The investigators propose the development of a range of nasal spray challenge models to study the way the nose can respond to different types of nasal challenge that elicit different forms of inflammation. The investigators will carry out nasal challenge with bacterial and viral components and allergens. In this way the nasal upper respiratory tract mucosa is challenged with stimuli of the immune system, causing various types of inflammation. Samples will be taken by blotting the nostril surface and by scraping off tiny surface samples. The nose will be sprayed with a substance that is a single part of a bacteria or virus, or with an allergen. The material delivered by nasal spray is of high purity and is sterile, containing no live bacteria or viruses. The nasal spray substance contains molecular patterns that are recognised as foreign by the immune system, and at the right dose should stimulate the immune system, causing mild nasal inflammation. The study employs noninvasive methods of sampling using absorptive strips. These strips look and feel like tissue paper, and are applied to each nostril for a period of 1 min. A few pinhead-sized tissue samples are taken from inside the nose, using a small disposable sterile plastic probe that has a tiny scoop on its end. In the nasal lining fluid and tissue samples, measurement will taken of a range of molecules and cells that protect against infections and help the immune response. By spraying the nose with a challenge agent in this manner, the nasal immune response can be assessed, which can help us better understand how the human immune system cells and molecules respond to bacteria and viruses. In the future, this may allow the testing of new drugs and vaccines, by seeing if they decrease or stop the inflammation after the nasal challenge.","other_id":"13SM1837","allocation":"Non-Randomized","intervention_model":"Factorial Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        INCLUSION CRITERIA\r\n\r\n        GENERAL FOR ALL SUBJECTS\r\n\r\n          -  Males and females aged 18 to 60 years\r\n\r\n          -  Current non-smokers for last year, maximum of 10 cigs per month, with a smoking\r\n             history of <5 pack years\r\n\r\n          -  Body mass index in the range18-39\r\n\r\n        HEALTHY NON-ATOPIC VOLUNTEERS\r\n\r\n          -  Negative skin prick tests to a range of 6 common aeroallergens: cat, dog, grass\r\n             pollen, tree pollen, house dust mite, fungal spores\r\n\r\n          -  Normal blood eosinophil count.\r\n\r\n        ATOPIC SUBJECTS WITH TIMOTHY GRASS POLLEN SENSITIVITY\r\n\r\n          -  A clinical history of seasonal grass pollen allergic rhinitis: sneezing, running and\r\n             itching nose, nasal drip in the UK grass pollen summer season (May-July).\r\n\r\n          -  Specific allergy confirmed by positive intra-epidermal skin prick test to Timothy\r\n             grass pollen extract (Soluprick, Phleum pratense; ALK, Horsholm, Denmark), a positive\r\n             reaction being a raised wheal of diameter >3mm larger than a negative saline control.\r\n\r\n        ASTHMATIC SUBJECTS WITH TIMOTHY GRASS POLLEN SENSITIVITY\r\n\r\n          -  Seasonal grass pollen allergic rhinitis: sneezing, running and itching nose, nasal\r\n             drip in the UK grass pollen summer season (May-July).\r\n\r\n          -  Specific allergy confirmed by positive intra-epidermal skin prick test to Timothy\r\n             grass pollen extract (Soluprick, Phleum pratense; ALK, Horsholm, Denmark), a positive\r\n             reaction being a raised wheal of diameter >3mm larger than a negative saline control.\r\n\r\n          -  Half the asthmatics have clinical history and diagnosis of asthma, requiring therapy\r\n             with occasional inhaled beta-agonists, but no inhaled corticosteroids for the past 28\r\n             days. Half the asthmatics receive regular combined inhaled corticosteroids and\r\n             long-acting beta-agonists (ICS/LABA)\r\n\r\n          -  For those asthmatics in the resiquimod (TLR 7/8 agonist) arm:\r\n\r\n        Methacholine PC20 < 8mg/ml\r\n\r\n        SUBJECTS WITH LATENT TUBERCULOSIS\r\n\r\n          -  Healthy with no lung nor systemic symptoms\r\n\r\n          -  Positive blood Interferon- release assay (IGRA): Quantiferon TB Gold- in-Tube\r\n             (QFT-it), >0.35 IU/ml IFN- versus control\r\n\r\n          -  Tuberculin skin test (TST), using RT23 tuberculin purified protein derivative (PPD),\r\n             from Statens Serum Institut (SSI) of Copenhagen. 2 tuberculin units (TU) in 0.1ml\r\n             injected intradermally (id) : >6mm to <25mm of induration at 48-72h.\r\n\r\n          -  Normal chest X-ray (CXR) or CT scan if performed routinely for clinical reasons\r\n\r\n        HEALTHY INTERFERON- RELEASE ASSAY (IGRA) NEGATIVE VOLUNTEERS\r\n\r\n          -  Age and sex matched to latent TB subjects\r\n\r\n          -  Healthy with no lung nor systemic symptoms\r\n\r\n          -  Negative blood Interferon- release assay (IGRA): Quantiferon TB Gold- in-Tube\r\n             (QFT-it), <0.35 IU/ml IFN- versus control\r\n\r\n          -  Tuberculin skin test (TST), using RT23 tuberculin purified protein derivative (PPD),\r\n             from Statens Serum Institut (SSI) of Copenhagen.\r\n\r\n          -  2 tuberculin units (TU) in 1ml injected intradermally (id): <6mm of induration at\r\n             48-72h.\r\n\r\n          -  Chest X-ray is not required\r\n\r\n        EXCLUSION CRITERIA\r\n\r\n        GENERAL\r\n\r\n          -  Recent infections in past 14 days before screening: especially upper respiratory tract\r\n             illnesses (including colds and influenza), sore throats, sinusitis, infective\r\n             conjunctivitis.\r\n\r\n          -  Lower respiratory tract infection in past 28 days\r\n\r\n          -  Signs or symptoms of significant nasal anatomical defects, hypertrophy of turbinates,\r\n             major septum deviation, nasal polyposis injury, ulceration or recurrent sinusitis\r\n\r\n          -  Previous nasal or sinus surgery\r\n\r\n          -  Systemic illnesses that might affect nasal immune responses\r\n\r\n          -  Medical therapy other than that permitted for contraception.\r\n\r\n          -  Treatment with local or systemic corticosteroids during the previous 1 month\r\n\r\n          -  Anti-inflammatory therapy: including non-steroidal anti-inflammatory drugs (NSAIDs)\r\n\r\n          -  tuberculosis at any stage in life\r\n\r\n          -  active infectious disease\r\n\r\n          -  cardiovascular diseases\r\n\r\n          -  respiratory (other than hay fever or asthma where specified)\r\n\r\n          -  hepatic, gastrointestinal, renal, endocrine, infective, haematological, autoimmune,\r\n             rheumatological, neurological, dermatological,\r\n\r\n          -  neoplastic conditions\r\n\r\n          -  metabolic diseases and extreme obesity\r\n\r\n          -  depression and psychiatric disorders\r\n\r\n          -  Non-smokers: up to 10 cigarettes a year is permitted\r\n\r\n          -  Participation in a therapeutic drug trial in the prior 30 days.\r\n\r\n          -  Inability or unwillingness to use contraception if the patient is a female of\r\n             child-bearing age.\r\n\r\n          -  Pregnant or breast feeding women\r\n\r\n          -  Inability to provide informed consent\r\n\r\n        HEALTHY NON-ATOPIC VOLUNTEERS\r\n\r\n          -  Clinical history of allergic rhinitis, allergic asthma or eczema\r\n\r\n        SUBJECTS WITH LATENT TUBERCULOSIS\r\n\r\n          -  Clinical history of active symptomatic tuberculosis (TB) infection\r\n\r\n          -  Chemoprophylaxis for TB\r\n\r\n        HEALTHY INTERFERON- RELEASE ASSAY (IGRA) NEGATIVE VOLUNTEERS\r\n\r\n          -  Clinical history of TB infection\r\n\r\n          -  Active nasal allergy\r\n\r\n          -  BCG vaccination\r\n      ","sponsor":"Imperial College London","sponsor_type":"Other","conditions":"Allergic Rhinitis|Asthma|Latent Tuberculosis","interventions":[{"intervention_type":"Other","name":"Other: TLR Agonist","description":"Preceding incremental ascending dose study to be used to assess top safe dose."},{"intervention_type":"Other","name":"Other: Tuberculin nasal challenge","description":"Preceding incremental ascending dose study to be used to assess safe top dose."},{"intervention_type":"Other","name":"Other: Timothy Grass Pollen","description":"Dose: 5000 SQ-U/100l"}],"outcomes":[{"outcome_type":"primary","measure":"To document a dose response and time course to nasal challenge in terms of cytokine levels in nasal mucosal lining fluid.","time_frame":"3 years"},{"outcome_type":"secondary","measure":"Change in peak nasal inspiratory flow and nasal symptom scores before and after nasal challenge agent.","time_frame":"3 years","description":"To develop a set of well tolerated, robust and reproducible (validated) nasal challenge systems with microbial constituents and allergen. To assess tolerability and clinical symptoms, measurements of peak nasal inspiratory flow, total nasal symptom scores as well as clincal examination of nasal mucosa will take place prior to and after administration of nasal challenge agents."},{"outcome_type":"secondary","measure":"To monitor levels of prostaglandin D2 after nasal challenge agent utilising a special probe that touches the surface of the nasal lining and is linked to a mass spectrometer.","time_frame":"3 years"},{"outcome_type":"secondary","measure":"To document a time course and dose response of nasal curettage mRNA expression in response to nasal challenge agents.","time_frame":"3 years"},{"outcome_type":"secondary","measure":"Change in nasal mucosal lining appearance on clinical examination before and after administration of nasal challenge agent.","time_frame":"3 years"},{"outcome_type":"secondary","measure":"Change in blood pressure, pulse, temperature before and after administration of nasal challenge agent.","time_frame":"3 years"}]}
{"nct_id":"NCT02110407","start_date":"2014-03-31","phase":"N/A","enrollment":24,"brief_title":"Modulation of Visual-Spatial Learning in Healthy Young Adults by tDCS","official_title":"Modulation of Visual-Spatial Learning in Healthy Young Adults by Transcranial Direct Current Stimulation - Proof of Principle and Mechanisms","primary_completion_date":"2017-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-05-31","last_update":"2017-07-27","description":"The aim of this study is to investigate whether a combination of intensive training of visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation (tDCS) leads to an improvement of learning and memory in healthy young adults and to examine the underlying neuronal mechanism.","other_id":"LOCATO-YA-tDCS","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":35,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  right handednesss\r\n\r\n          -  unobtrusive neuropsychological screening\r\n\r\n          -  age: 18-35 years\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  severe internal or psychiatric disease\r\n\r\n          -  epilepsy\r\n\r\n          -  other severe neurological disease, e.g. previous major stroke, brain tumor\r\n\r\n          -  DMS-IV manifest dementia\r\n\r\n          -  contraindication for MRT (claustrophobia, metallic implants, tattoos)\r\n      ","sponsor":"Charite University, Berlin, Germany","sponsor_type":"Other","conditions":"Healthy Young Adults","interventions":[{"intervention_type":"Device","name":"Device: tDCS","description":"transcranial direct current stimulation (tDCS)"},{"intervention_type":"Behavioral","name":"Behavioral: training","description":"intensive training of visual-spatial abilities (in LOCATO task)"}],"outcomes":[{"outcome_type":"primary","measure":"performance in LOCATO task (visual-spatial learning and memory) after a combination of intensive visual-spatial training and tDCS","time_frame":"immediately after end of a 3 day period of training in tDCS condition vs sham condition","description":"Investigation whether the combination of intensive visual-spatial training (LOCATO task) and tDCS leads to improvement of visual-spatial learning and memory measured by the performance in LOCATO task after end of a 3 day period of training compared to sham stimulation."},{"outcome_type":"secondary","measure":"long term effects","time_frame":"after 1 month vs baseline","description":"long term effetcs measured by performance in LOCATO task after end of training and after 1 month compared to control conditions"},{"outcome_type":"secondary","measure":"functional changes: Connectivity","time_frame":"after end of 3-day cognitive training vs baseline","description":"Connectivity (measured by resting-state fMRT and correlation analysis) at baseline compared to end of training"},{"outcome_type":"secondary","measure":"cortical excitability","time_frame":"at baseline","description":"cortical excitability measured by transcranial magnetic stimulation (TMS)"},{"outcome_type":"secondary","measure":"Quality of Life","time_frame":"after 1 month vs baseline","description":"quality of life as measured by standardized questionaire at baseline compared to quality of life measured 1 month after intervention (training and stimulation vs. training and sham-stimualtion)"},{"outcome_type":"secondary","measure":"memory","time_frame":"immediately after end of 3-day of cognitive training, after 1 month vs. baseline","description":"memory performance tested at baseline compared to memory performance after the end of a 3-day cognitive training period and after 1 month (posttraining) in training and stimulation vs. training and sham stimulation"},{"outcome_type":"secondary","measure":"genotyping of learning related polymorphisms","time_frame":"once","description":"To assess predictors of positive reaction to brain stimulation, genotyping of several learning related polymorphisms will be performed (i.e., APOE, BDNF Val66Met, COMT Val158Met)."}]}
{"nct_id":"NCT02011503","start_date":"2014-03-31","phase":"N/A","enrollment":128,"brief_title":"Use of dHACM in the Treatment of Venous Leg Ulcers","official_title":"A Randomized Controlled Clinical Trial Evaluating The Application Of Dehydrated Human Amnion/ Chorion Membrane (dHACM) Plus Standard Of Care Vs. Standard Of Care Alone In The Treatment Of Venous Leg Ulcers","primary_completion_date":"2017-08-05","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-11-30","last_update":"2018-08-24","description":"The overall objective of this study is to evaluate the effectiveness of dehydrated human amnion/ chorion membrane (dHACM) in reducing time to complete wound closure in patients with venous leg ulcers (VLUs).","other_id":"EFVLU003","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Index ulcer characteristics:\r\n\r\n               1. Full-thickness venous leg ulcer for  30 days\r\n\r\n               2. Ulcer area after debridement is  1 cm and  25 cm at the randomization visit\r\n\r\n               3. Has a clean, granulating base with minimal adherent slough\r\n\r\n          2. Subject has completed 14 day run-in period with  25% wound area reduction\r\n             post-debridement.\r\n\r\n          3. Have one of the following:\r\n\r\n               -  Ankle Brachial Pressure Index (ABI) > 0.75. (Calculations will be made using\r\n                  measurements from both posterior tibial and dorsalis pedis arteries as well as\r\n                  both arms) OR\r\n\r\n               -  Have venous insufficiency confirmed by duplex ultrasound examination for valvular\r\n                  or venous incompetence.\r\n\r\n          4. Age  18.\r\n\r\n          5. Females of childbearing potential must be willing to use acceptable methods of\r\n             contraception (birth control pills, barriers, or abstinence).\r\n\r\n          6. Ability to read/understand and sign Informed Consent and Release of Medical\r\n             Information Forms.\r\n\r\n          7. Ability to understand and comply with weekly visits and follow-up regimen.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Index Ulcer Assessment - Index ulcer meeting the following criteria will not be\r\n             eligible for enrollment:\r\n\r\n               1. Penetrates down to muscle, tendon, or bone\r\n\r\n               2. Presence of another venous ulcer  2 cm from index ulcer\r\n\r\n               3. Is deemed by the Investigator to be caused by a medical condition other than\r\n                  venous insufficiency\r\n\r\n               4. Exhibits clinical signs and symptoms of infection\r\n\r\n               5. If in the opinion of the Investigator, the wound is suspicious for cancer, the\r\n                  subject should undergo an ulcer biopsy to rule out carcinoma. If carcinoma is\r\n                  ruled out, the subject may be re-screened.\r\n\r\n               6. Located on the dorsum of the foot or with more than 50% of the ulcer below the\r\n                  malleolus\r\n\r\n          2. Prior therapies - Subjects receiving treatment with any of the following will not be\r\n             eligible for enrollment:\r\n\r\n               1. In the last 7 days - Negative pressure wound therapy of the index ulcer\r\n\r\n               2. In the last 7 days - Hyperbaric oxygen therapy\r\n\r\n               3. In the last 30 days - Treatment with cytotoxic chemotherapy, application of\r\n                  topical steroids to the ulcer surface, or use of  14 days of immune-suppressants\r\n                  (including systemic corticosteroids); or, subject is anticipated to require such\r\n                  medications during the course of the study\r\n\r\n               4. In the last 30 days - study ulcer treatment with any advanced therapy, including\r\n                  EpiFix, tissue engineered materials (e.g. Apligraf or Dermagraft), or other\r\n                  scaffold materials (e.g. OASIS Wound Matrix, MatriStem Wound Matrix)\r\n\r\n               5. In the last 30 days - Subject has been on any investigational drug(s) or\r\n                  therapeutic device(s)\r\n\r\n               6. In the last 8 weeks - Amputation or revascularization (surgical or stenting) to\r\n                  the affected leg\r\n\r\n               7. Any history of radiation at the ulcer site\r\n\r\n               8. Any prior participation in a MiMedx study\r\n\r\n               9. Study ulcer has undergone  12 months of continuous high strength compression\r\n                  therapy over its duration\r\n\r\n          3. Subject criteria that will make subject ineligible for enrollment:\r\n\r\n               1. Known osteomyelitis or active cellulitis at wound site\r\n\r\n               2. Hemoglobin A1C >12 in the last 60 days prior to randomization\r\n\r\n               3. Active malignant disease or subject is less than 1 year disease-free\r\n\r\n               4. NYHA Class III and IV congestive heart failure (CHF), as defined by the following\r\n                  criteria: Class III: Symptoms with moderate exertion; Class IV: Symptoms at rest\r\n\r\n               5. Auto-immune disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia,\r\n                  Acquired Immunodeficiency Syndrome (AIDS) or HIV\r\n\r\n               6. Allergy or known sensitivity to Aminoglycosides such as gentamicin sulfate and/or\r\n                  streptomycin sulfate\r\n\r\n               7. Known allergy to the components of the multi-layer compression bandaging, or who\r\n                  cannot tolerate MLCT\r\n\r\n               8. Presence of any condition (including current drug or alcohol abuse, medical or\r\n                  psychiatric condition) that is likely to impair understanding of or compliance\r\n                  with the study protocol in the judgment of the Investigator\r\n\r\n               9. Pregnancy at enrollment or within last 6 months, women who are breastfeeding, or\r\n                  women of childbearing potential who are planning to become pregnant during the\r\n                  time of the study OR are unwilling/unable to use acceptable methods of\r\n                  contraception (birth control pills, barriers, or abstinence)\r\n      ","sponsor":"MiMedx Group, Inc.","sponsor_type":"Industry","conditions":"Leg Ulcer","interventions":[{"intervention_type":"Procedure","name":"Procedure: Multi-layer compression therapy","description":"Application of multi-layer compression therapy."},{"intervention_type":"Other","name":"Other: Application of dHACM","description":"Application of dHACM to ulcer."}],"outcomes":[{"outcome_type":"primary","measure":"Time to 100% epithelialization of study ulcer","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"Proportion of patients in both groups with complete wound healing at 12 weeks","time_frame":"12 weeks"},{"outcome_type":"other","measure":"Comparison of Quality of Life as assessed by Short Form 36 (SF-36)","time_frame":"16 weeks"},{"outcome_type":"other","measure":"Crossover Subject Analysis","time_frame":"12 weeks"}]}
{"nct_id":"NCT02935829","start_date":"2014-03-31","phase":"N/A","enrollment":140,"brief_title":"Short-term Effects of a Carob Snack on Postprandial Glycemic Responses and Energy Intake and Satiety","official_title":"Short-term Effects of a Low Glycemic Index Snack Including Carob on Postprandial Glycemic Responses, Energy Intake and Satiety in Normal-weight, Healthy Adults","primary_completion_date":"2015-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-09-30","last_update":"2017-01-20","description":"This study investigated any potential associations between two preloads offered as snacks and postprandial glycemic response, subjective and objective appetite and energy intake in healthy, normal-weight adults.","other_id":"304","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Other","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        - Healthy, non-smoking, non-diabetic men and women individuals with normal body mass index\r\n        (BMI; between 18.5 and 24.9 kg/m2)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Severe chronic disease (e.g. tumors, manifest coronary heart disease, diabetes\r\n             mellitus, severe kidney or liver conditions, endocrine and immunological conditions)\r\n\r\n          -  Gastrointestinal disorders (e.g. chronic inflammatory bowel disease)\r\n\r\n          -  Lactose intolerance\r\n\r\n          -  Pregnancy\r\n\r\n          -  Competitive sports\r\n\r\n          -  Lactation\r\n\r\n          -  Alcohol\r\n\r\n          -  Drug dependency\r\n      ","sponsor":"Agricultural University of Athens","sponsor_type":"Other","conditions":"Potential Abnormality of Glucose Tolerance|Appetite; Lack or Loss, Nonorganic Origin","interventions":[{"intervention_type":"Other","name":"Other: Glucose as reference food","description":"Ten subjects (male: 6, female: 4) consumed 25g glucose diluted in 250ml water, two times, in different weeks, within 5-10 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min."},{"intervention_type":"Other","name":"Other: White bread as reference food","description":"Ten subjects (male: 6, female: 4) consumed 25g available carbohydrate from white bread along with 250ml water, two times, in different weeks, within 10-15 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min."},{"intervention_type":"Other","name":"Other: Carob snack as test food","description":"Ten subjects (male: 6, female: 4) consumed 25g available carbohydrate from carob snack along with 250ml water, one time, in different weeks, within 10-15 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min."},{"intervention_type":"Other","name":"Other: Chocolate cookie snack as test food","description":"Ten subjects (male: 6, female: 4) consumed 25g available carbohydrate from chocolate cookie snack along with 250ml water, one time, in different weeks, within 10-15 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min."},{"intervention_type":"Other","name":"Other: Carob preload","description":"Fifty healthy subjects (male: 22, female: 28) consumed a standardized breakfast (bread and honey) and 2h after were offered a preload given as snack (40g carob snack). Three hours after, subjects were given ad libitum access to a meal (lunch and dessert). The meal consisted of rice, roasted chicken breast and chocolate cake. Foods were weighed before serving and any leftovers were weighed again after meal. Fingertip capillary blood glucose samples were taken before breakfast, 120min after breakfast; before preload, 120minand 180minpost-preload consumption; before meal (lunch and dessert), 60minand 120min post-meal consumption. Subjective appetite ratings were assessed with 100mm VAS."},{"intervention_type":"Other","name":"Other: Chocolate cookie preload","description":"Fifty healthy subjects (male: 22, female: 28) consumed a standardized breakfast (bread and honey) and 2h after were offered a preload given as snack (40g chocolate cookie). Three hours after, subjects were given ad libitum access to a meal (lunch and dessert). The meal consisted of rice, roasted chicken breast and chocolate cake. Foods were weighed before serving and any leftovers were weighed again after meal. Fingertip capillary blood glucose samples were taken before breakfast, 120min after breakfast; before preload, 120minand 180minpost-preload consumption; before meal (lunch and dessert), 60minand 120min post-meal consumption. Subjective appetite ratings were assessed with 100mm VAS."}],"outcomes":[{"outcome_type":"primary","measure":"Capillary blood glucose and subjective appetite ratings","time_frame":"7 hours","description":"Clinically useful change in serum glucose, defined as the restoration of glucose within normal limits during the 2hr glucose tolerance test. Useful change in subjective appetite (hunger, desire to eat, motivation to eat, preoccupation with thoughts of food, thirst) scores from 100mm VAS"},{"outcome_type":"secondary","measure":"Subjective appetite ratings","time_frame":"6 hours","description":"Useful change in subjective appetite (hunger, desire to eat, motivation to eat, preoccupation with thoughts of food, thirst) scores from 100mm VAS"},{"outcome_type":"secondary","measure":"Energy intake after preload","time_frame":"2 hours","description":"Useful change in energy intake the day of the intervention (actual weighing of foods consumed and leftovers and 24hr recall)"},{"outcome_type":"secondary","measure":"Energy intake next 24hours","time_frame":"2 days","description":"Useful change in energy intake in the next 24hr (24hr recall) after intervention"}]}
{"nct_id":"NCT02038959","start_date":"2014-03-31","phase":"N/A","enrollment":210,"brief_title":"Connect.Parkinson: Connecting Individuals With Parkinson Disease to Specialists in Their Homes","official_title":"Using Technology to Deliver Multi-disciplinary Care to Individuals With Parkinson Disease in Their Homes: the Connect.Parkinson Study","primary_completion_date":"2016-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-08-31","last_update":"2017-01-27","description":"Connect.Parkinson is a randomized comparative effectiveness study, comparing usual care enhanced with educational materials to usual care, educational materials, and the delivery of specialty care via telemedicine into patient's homes. The study's specific aims are the following: 1. To demonstrate the feasibility of using telemedicine to deliver specialty care into the homes of individuals with Parkinson disease who have limited access to care; 2. To show that such an approach can improve quality of life; 3. To establish that the telemedicine can enhance the quality of care; and 4. To demonstrate that this remote approach to care saves time, reduces travel, and decreases care partner burden.","other_id":"AD-12-11-4701","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":30,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Individuals with clinically diagnosed Idiopathic Parkinson disease in the judgment of\r\n             the independent rater\r\n\r\n          -  No better alternative explanation for the parkinsonism\r\n\r\n          -  Access to a non-public, internet-enabled device (e.g., computer, tablet computer,\r\n             smart phone) that has the capacity for web-based video conferencing\r\n\r\n          -  Be physically located at time visits are conducted in a state where the participating\r\n             physician is licensed to practice medicine\r\n\r\n          -  Have a local care provider that the study team can contact\r\n\r\n          -  Live at home, in a senior housing complex, or assisted living facility\r\n\r\n          -  Be fluent in English (all participating states) or Spanish (participants in Florida\r\n             and Massachusetts only)\r\n\r\n          -  Willing and able to provide informed consent\r\n\r\n          -  Care partner (if applicable) must be able and willing to provide informed consent to\r\n             participate if he or she so chooses.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Currently hospitalized\r\n\r\n          -  Condition (e.g., prominent psychosis) that precludes study participation as identified\r\n             by the medical professional (site investigator or nurse).\r\n\r\n          -  Participation in another telemedicine study.\r\n      ","sponsor":"University of Rochester","sponsor_type":"Other","conditions":"Parkinson Disease","interventions":[{"intervention_type":"Other","name":"Other: Virtual Visits","description":"Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."}],"outcomes":[{"outcome_type":"primary","measure":"Feasibility of Virtual Visits for Parkinson Disease","time_frame":"One year","description":"Feasibility of virtual visits will be determined by the number of participants who complete at least one virtual visit successfully."},{"outcome_type":"primary","measure":"Change From Baseline in the Quality of Life Measured by Parkinson Disease Questionnaire 39","time_frame":"Baseline to One year","description":"Assessed as the change in quality of life, measured by the Parkinson Disease Questionnaire 39 (PDQ-39). The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality over the last month. Assesses how often patients experience difficulties across the 8 quality of life dimensions. Assesses impact of Parkinson's Disease (PD) on specific dimensions of functioning and well-being. The score ranges from 0-100 with lower scores reflecting better quality of life."},{"outcome_type":"secondary","measure":"Change in EQ-5D Index Value","time_frame":"baseline to one year","description":"EuroQol five dimensions questionnaire (EQ-5D) is a standardized instrument for measuring generic health status. Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale ranges from 11111 to 55555 with higher numbers indicating worse health status. The five-digit descriptors are converted to EQ-5D Index Values, which range from -0.109 (corresponding to 55555, the worst possible health) to 1.000 (corresponding to 11111, the best possible health)."},{"outcome_type":"secondary","measure":"Change in Montreal Cognition Assessment","time_frame":"baseline to one year","description":"We will assess changes in cognition from baseline to the end of the study using the Montreal Cognitive Assessment (MoCA), administered remotely. The scale ranges from 0-30 with higher numbers indicating better cognition."},{"outcome_type":"secondary","measure":"Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part IA","time_frame":"baseline to one year","description":"Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part I concerns nonmotor experiences of daily living. The scale ranges from 0 to 24 with higher numbers indicated more severe disease."},{"outcome_type":"secondary","measure":"Change in Patient Assessment of Chronic Illness Care","time_frame":"baseline to one year","description":"We will assess change in the perceived quality of care using the Patient Assessment of Chronic Illness Care (PACIC). Each scale is scored by averaging the items completed within that scale, and the overall PACIC is scored by averaging scores across all 20 items. The scale ranges from 1-5 with higher scores indicating better care by the health team."},{"outcome_type":"secondary","measure":"Minutes Spend on Last Parkinson's Disease Provider Visit","time_frame":"One year"},{"outcome_type":"secondary","measure":"Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part IB","time_frame":"baseline to one year","description":"Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part I concerns nonmotor experiences of daily living. The scale ranges from 0 to 52 with higher numbers indicated more severe disease."},{"outcome_type":"secondary","measure":"Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 2","time_frame":"baseline to one year","description":"Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part II concerns motor experiences of daily living. The scale ranges from 0 to 52 with higher numbers indicated more severe disease."},{"outcome_type":"secondary","measure":"Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 3","time_frame":"baseline to one year","description":"Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part III is retained as the motor examination. The scale ranges from 0 to 108 with higher numbers indicated more severe disease."},{"outcome_type":"secondary","measure":"Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 4","time_frame":"baseline to one year","description":"Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part IV concerns motor complications. The scale ranges from 0 to 24 with higher numbers indicated more severe disease."}]}
{"nct_id":"NCT02114385","start_date":"2014-03-24","phase":"Phase 3","enrollment":500,"brief_title":"A Study to Compare Immune Response of V503 to Gardasil in 16- to 26-year-old Men (V503-020)","official_title":"A Randomized, Double-Blinded, Controlled With GARDASIL (Human Papillomavirus Vaccine [HPV] [Types 6, 11, 16, 18] (Recombinant, Adsorbed)), Phase 3 Clinical Trial to Study the Immunogenicity and Tolerability of V503 (9-Valent Human Papillomavirus L1 Virus-Like Particle [VLP] Vaccine) in 16- to 26-year-old Men","primary_completion_date":"2015-04-22","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-04-22","last_update":"2018-11-01","description":"Primary objective To demonstrate that administration of V503 induces non-inferior Geometric Mean Titres (GMTs) for serum anti-HPV 6, 11, 16, and 18, compared to GARDASIL in 16- to 26-year-old men","other_id":"V503-020","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":16,"maximum_age":26,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subject is a man, between the ages of 16 years and 0 days and 26 years and 364 days on\r\n             the day of enrolment.\r\n\r\n          -  Subject is a man who has had no more than 5 lifetime female sexual partners.\r\n\r\n          -  Subject is judged to be in good physical health on the basis of medical history,\r\n             physical examination, and laboratory results.\r\n\r\n          -  Subject, or subject's parent or guardian, fully understand study procedures,\r\n             alternative treatments available, the risks involved with the study, and voluntarily\r\n             agree to participate by giving written informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subject who has had sex with a male partner.\r\n\r\n          -  Subject has a history of HPV-related external genital lesions or HPV-related anal\r\n             lesions\r\n\r\n          -  Subject has a known allergy to any vaccine component, including aluminium, yeast, or\r\n             BENZONASE\r\n\r\n          -  Subject has a history of severe allergic reaction that required medical intervention.\r\n\r\n          -  Subject has thrombocytopenia or any coagulation disorder that would contraindicate\r\n             intramuscular injections.\r\n\r\n          -  Subject is concurrently enrolled in clinical studies of investigational medicinal\r\n             products.\r\n\r\n          -  Subject has donated blood within 1 week prior to the Day 1 vaccination, or intends to\r\n             donate during Day 1 through Month 7 of the study.\r\n\r\n          -  Subject is currently immunocompromised or has been diagnosed as having a congenital or\r\n             acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus\r\n             erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel\r\n             disease, or other autoimmune condition.\r\n\r\n          -  Subject has had a splenectomy.\r\n\r\n          -  Subject is receiving or has received in the year prior to enrolment the following\r\n             immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine,\r\n             methotrexate, any chemotherapy, cyclosporin, leflunomide, TNF- antagonists,\r\n             monoclonal antibody therapies, intravenous gamma globulin, antilymphocyte sera, or\r\n             other therapy known to interfere with the immune response.\r\n\r\n          -  Subject has received any immune globulin product or blood-derived product within the 6\r\n             months prior to the Day 1 vaccination, or plans to receive any such product during Day\r\n             1 through Month 7 of the study.\r\n\r\n          -  Subject has received non-replicating (inactivated) vaccines within 14 days prior to\r\n             the Day 1 vaccination or has received replicating (live) vaccines within 21 days prior\r\n             to the Day 1 vaccination.\r\n\r\n          -  Subject has received a marketed HPV vaccine, or has participated in an HPV vaccine\r\n             clinical trial and has received either active agent or placebo.\r\n\r\n          -  Subject has had a fever within the 24-hour period prior to the Day 1 vaccination.\r\n\r\n          -  Subject has a history or current evidence of any condition, therapy, laboratory\r\n             abnormality or other circumstance that might confound the results of the study, or\r\n             interfere with the subject's participation for the full duration of the study, such\r\n             that it is not in the best interest of the subject to participate.\r\n\r\n          -  Subject is unlikely to adhere to the study procedures, keep appointments, or is\r\n             planning to relocate during the study.\r\n\r\n          -  Subject is, at the time of signing informed consent, a user of recreational or illicit\r\n             drugs or has had a recent history (within the last year) of drug abuse or dependence.\r\n             Alcohol abusers are defined as those who drink despite recurrent social,\r\n             interpersonal, and/or legal problems as a result of alcohol use.\r\n\r\n          -  Subject, or subject's parent or guardian, is or has an immediate family member (spouse\r\n             or children) who is investigational site or sponsor staff directly involved with this\r\n             trial.\r\n      ","sponsor":"Merck Sharp & Dohme Corp.","sponsor_type":"Industry","conditions":"Papilloma Viral Infection","interventions":[{"intervention_type":"Biological","name":"Biological: V503","description":"9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection"},{"intervention_type":"Biological","name":"Biological: GARDASIL","description":"Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection"}],"outcomes":[{"outcome_type":"primary","measure":"Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18","time_frame":"4 weeks postdose 3 (Month 7)","description":"Serum antibodies to HPV types 6, 11, 16, and 18 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL."},{"outcome_type":"secondary","measure":"GMTs to HPV Types 31/33/45/52/58","time_frame":"4 weeks postdose 3 (Month 7)","description":"Serum antibodies to HPV types 31, 33, 45, 52, and 58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL."},{"outcome_type":"secondary","measure":"Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18/31/33/45/52/58","time_frame":"4 weeks postdose 3 (Month 7)","description":"Serum antibodies to HPV types were measured with a Competitive Luminex Immunoassay. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24; HPV Type 31: ≥10; HPV Type 33: ≥8; HPV Type 45: ≥8; HPV Type 52: ≥8; HPV Type 58: ≥8."},{"outcome_type":"secondary","measure":"Percentage of Participants With One or More Adverse Events","time_frame":"Up to 15 days after any vaccination","description":"The percentage of participants with one or more adverse events was assessed."},{"outcome_type":"secondary","measure":"Percentage of Participants With Study Discontinuation Due to an Adverse Event","time_frame":"Up to Month 7","description":"The percentage of participants discontinued from the study due to an adverse event was assessed."},{"outcome_type":"secondary","measure":"Percentage of Participants With One or More Injection-site Adverse Reactions","time_frame":"Up to 5 days after any vaccination","description":"The percentage of participants with one or more injection-site adverse reactions (solicited or unsolicited) was assessed."},{"outcome_type":"secondary","measure":"Percentage of Participants With Maximum Temperature ≥37.8 °C","time_frame":"Up to 5 days after any vaccination","description":"The percentage of participants with a maximum temperature ≥37.8 °C was assessed."},{"outcome_type":"secondary","measure":"Percentage of Participants With One or More Systemic Adverse Events","time_frame":"Up to 15 days after any vaccination","description":"The percentage of participants with one or more systemic adverse events was assessed."},{"outcome_type":"secondary","measure":"Percentage of Participants With One or More Serious Adverse Events","time_frame":"Up to 15 days after any vaccination","description":"The percentage of participants with one or more serious adverse events was assessed."}]}
{"nct_id":"NCT01812278","start_date":"2014-03-24","phase":"N/A","enrollment":2637,"brief_title":"Randomized Trial of Web-Delivered Acceptance Therapy for Smoking Cessation (WebQuit)","official_title":"Randomized Trial of Web-Delivered Acceptance Therapy for Smoking Cessation","primary_completion_date":"2016-10-26","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-12-31","last_update":"2020-07-31","description":"The goal of this study is to determine whether the ACT website provides higher quit rates than a current standard smoking cessation website.","other_id":"7859","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":99,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  age 18 or older\r\n\r\n          -  smokes at least five cigarettes daily for at least past 12 months\r\n\r\n          -  wants to quit in next 30 days\r\n\r\n          -  willing to be randomly assigned to either group\r\n\r\n          -  resides in US\r\n\r\n          -  has at least weekly access to a high speed Internet connection and email\r\n\r\n          -  willing and able to read in English\r\n\r\n          -  not participating in other smoking cessation interventions (including our other\r\n             intervention studies\r\n\r\n          -  has never used the Smokefree.gov website\r\n\r\n          -  willing to complete all three follow-up surveys\r\n\r\n          -  provide email, phone, and mailing address\r\n\r\n          -  provide contact information for two collaterals (e.g., relatives).\r\n\r\n          -  does not have family, friends, or other household members participating\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  The exclusion criteria are the opposite of the inclusion criteria above.\r\n      ","sponsor":"Fred Hutchinson Cancer Research Center","sponsor_type":"Other","conditions":"Smoking","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: ACT"},{"intervention_type":"Behavioral","name":"Behavioral: CBT"}],"outcomes":[{"outcome_type":"primary","measure":"30-day point prevalence abstinence","time_frame":"12 month post randomization","description":"No smoking in the past 30 days, as reported 12 month post treatment."},{"outcome_type":"secondary","measure":"7-day, 24-hour, and 30-day point prevalence quit rates","time_frame":"3 months, 6 months, and 12 months post treatment","description":"12 months: 24-hour and 7-day point prevalence quit rates. 3 and 6 months: 24-hour, 7-day, and 30-day point prevalence quit rates. Across 3, 6, and 12 month timepoints, the repeated 30-day point prevalence abstinence."}]}
{"nct_id":"NCT02052440","start_date":"2014-03-15","phase":"Phase 3","enrollment":102,"brief_title":"Preventing Alcohol Withdrawal Syndrome With Oral Baclofen","official_title":"Preventing Alcohol Withdrawal Syndrome With Oral Baclofen: A Randomized, Placebo Controlled Trial","primary_completion_date":"2017-01-01","study_type":"Interventional","rec_status":"Terminated","completion_date":"2017-01-01","last_update":"2018-05-23","description":"Adult medical/surgical inpatient hospital care is more difficult and more expensive when complicated by alcohol dependency (AD), especially for patients who develop alcohol withdrawal syndrome (AWS). AWS can be mild, moderate or severe. The Severity of Ethanol Withdrawal Scale (SEWS) is tool used to assess severity and is the current standard of care for both monitoring and treating AWS at Denver Health. Moderate/severe AWS (i.e., SEWS  7) has important clinical implications and requires pharmacological treatment. At present, there are no safe and effective options for preventing AWS in at-risk inpatients. Baclofen is a GABA-B receptor agonist that has been used in the alleviation of spasticity in patients with multiple sclerosis since the 1970s. Baclofen has shown promise in the management of alcohol dependency in preclinical and clinical studies. We propose to examine baclofen in the prevention/amelioration of AWS in adult medical inpatients. The investigators hypothesize that Baclofen, as compared to placebo, will significantly reduce the number of adult inpatients with AD who will develop moderate/severe AWS (SEWS  7) when assessed at 72 hours after enrollment. Further the investigators hypothesize that Baclofen, as compared to placebo, will significantly reduce the need for symptom-triggered benzodiazepine administration during the 72 hours of hospitalization. These hypotheses will be tested in adult inpatients who are determined to be at risk for alcohol withdrawal and are subsequently placed on the SEWS monitoring and treatment protocol. These patients will be randomized to baclofen 10mg three times daily vs placebo.","other_id":"13-2883","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":21,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adults age 21-100 admitted to medical floors at Denver Health\r\n\r\n          -  Patients placed on SEWS protocol by admitting physicians (at risk for AWS).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Unable to provide informed consent\r\n\r\n          -  Unable to take oral medications\r\n\r\n          -  admitted for AWS or with SEWS score >7 at baseline\r\n\r\n          -  no alcohol intake for  48 hours\r\n\r\n          -  baclofen use at baseline\r\n\r\n          -  baclofen sensitivity\r\n\r\n          -  hospital discharge anticipated in within 48 hours\r\n\r\n          -  pregnant or breast feeding (urine pregnancy test required of women of child-bearing\r\n             potential\r\n\r\n          -  other active drug dependence (except tobacco)\r\n\r\n          -  taking a medication known to interact with baclofen.\r\n      ","sponsor":"Denver Health and Hospital Authority","sponsor_type":"Other","conditions":"Alcohol Withdrawal Syndrome","interventions":[{"intervention_type":"Drug","name":"Drug: Baclofen","description":"Treatment arm: baclofen 10mg tid"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Sugar pill by mouth three times daily"}],"outcomes":[{"outcome_type":"primary","measure":"Prevention of Progression to Severe Alcohol Withdrawal as Assessed by Severity of Ethanol Withdrawal Score (SEWS).","time_frame":"Within 72 hours","description":"Prevention of progression to Severe Alcohol withdrawal as assessed by Severity of Ethanol Withdrawal Score (SEWS). A score of > 7 represents moderate alcohol withdrawal and a score > 12 severe alcohol withdrawal. Reported below as number of patients in each group progressing to moderate or severe alcohol withdrawal as assessed by SEWS score."},{"outcome_type":"secondary","measure":"Reduced Severity of Alcohol Withdrawal as Measured by Severity of Ethanol Withdrawal Score. .","time_frame":"Over 72 hours","description":"Severity of alcholol withdrawal will be assessed by monitoring SEWS scores in both baclofen and placebo group. This score is reported as a cumulative unit on scale ranging from 0 to 23. A value of 1-6 represents mild alcohol withdrawal, 7-12 moderate and >12 severe. Values will be measured 24 hours, 48 hours and 72 hours. A mean of these values was calculated."},{"outcome_type":"secondary","measure":"Difference in Maximal Dose of Ethanol Withdrawal Symptom Driven Benzodiazepine Administration, as Assessed by SEWS Score, in Treatment Group When Compared to Placebo Group","time_frame":"72 hours","description":"The null hypotheses of no difference in the maximum dose of inpatient symptom-triggered benzodiazepine therapy during the 72 hours following enrollment between those who receive baclofen and those who receive placebo. All maximum doses for each treatment arm given anytime between 0 and 72 hours were recorded and a mean calculated for each treatment arm."},{"outcome_type":"secondary","measure":"Difference in Cumulative Dose of Ethanol Withdrawal Symptom Driven Benzodiazepine Administration, as Assessed by SEWS Score, in Treatment Group Compared With Placebo Group.","time_frame":"72 hours","description":"The null hypotheses of no difference in the cumulative inpatient dosages of symptom-triggered benzodiazepine therapy during the 72 hours following enrollment between those who receive baclofen and those who receive placebo. Total benzodiazepine administration received from 0 to 72 hours was summed for each patient in each arm. A mean of this cumulative dose was then calculated for each arm and is reported below."}]}
{"nct_id":"NCT03165643","start_date":"2014-03-06","enrollment":239,"brief_title":"The DNA Methylation of ARHGEF11 in Macrosomia","official_title":"Epigenetic Alteration of Rho Guanine Nucleotide Exchange Factor 11 (ARHGEF11) in Cord Blood Samples in Macrosomia Exposed to Intrauterine Hyperglycaemia","primary_completion_date":"2014-10-18","study_type":"Observational","rec_status":"Completed","completion_date":"2014-10-18","last_update":"2017-05-24","description":"Background Macrosomia at birth is associated with subsequent susceptibility to obesity, abnormal glucose metabolism, hypertension and dyslipidaemia. Epigenetic reprogramming has been reported to be involved in the development of human diseases caused by suboptimal environmental or nutritional factors. Objective The study was aiming to explore epigenetic mechanism influences on macrosomic infants exposed to intrauterine hyperglycemia. Design The investigators performed a genome-wide analysis of DNA methylation in cord blood from macrosomic infants born to women with gestational diabetes or infants with normal birth weight born to normal glucose-tolerant women in order to identify genes related to foetal growth or early adipose tissue development. The candidate genes were then validated using SEQUENOM MassARRAY after bisulfite conversion.","other_id":"2013572","observational_model":"Case-Control","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"Female","population":"Singleton term pregnant women in Peking University First Hospital were recruited in this\r\n        study.","criteria":"\n        Inclusion Criteria:\r\n\r\n        -\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnancies complicating with hypertensive disorders, pre-gestational diabetes,\r\n             thyroid diseases, renal dysfunction were excluded.\r\n      ","sponsor":"Peking University First Hospital","sponsor_type":"Other","conditions":"Gestational Diabetes|Diabetes|Macrosomia, Fetal","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: OGTT","description":"75 g glucose tolerance test was provided to all pregnant women during 24-28 weeks."}],"outcomes":[{"outcome_type":"primary","measure":"GDM was identified","time_frame":"24-28 weeks","description":"According to the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria, gestational diabetes mellitus (GDM) was diagnosed when at least one cut point was reached in 2-hour 75-g OGTT test: a fasting plasma glucose (FPG) ≥ 5.1 mmol/L (92 mg/dL), a 1-hour ≥ 10.0 mmol/L (180 mg/dL) or a 2-hour ≥ 8.5 mmol/L (153 mg/dL). Participants were divided into two groups based on OGTT: Group normal glucose tolerant (NGT, n=132) and Group GDM (n=107)."},{"outcome_type":"primary","measure":"Foetal macrosomia was identified","time_frame":"40 weeks","description":"After delivery, participants were further divided into four subgroups based on neonatal birth weight: normal birth weight (NBW) was defined as 2500g ≤ birth weight < 4000g, macrosomia (Mac) was defined as birth weight ≥ 4000g. Group NGT-NBW (n=83): normal glucose tolerant women with normal neonatal birth weight; Group NGT-Mac (n=49): normal glucose tolerant women with macrosomia; Group GDM-NBW (n=82): GDM women with normal neonatal birth weight; Group GDM-Mac (n=25): GDM women with macrosomia."},{"outcome_type":"primary","measure":"DNA methylation level in macrosomia","time_frame":"40 weeks","description":"Investigators performed a genome-wide analysis of DNA methylation in cord blood from macrosomic infants born to women with gestational diabetes or infants with normal birth weight born to normal glucose-tolerant women in order to identify genes related to foetal growth or early adipose tissue development. The candidate genes were then validated using SEQUENOM MassARRAY after bisulfite conversion."}]}
{"nct_id":"NCT04485390","start_date":"2014-03-01","enrollment":150,"brief_title":"Impact of the Organization of the First Responders in the Remote Areas on Cardiac Arrest Victim Survival","official_title":"Impact of the Organization of the First Responders in the Remote Areas on Cardiac Arrest Victim Survival: an Utstein Analysis","primary_completion_date":"2019-12-31","study_type":"Observational","rec_status":"Active, not recruiting","completion_date":"2020-12-31","last_update":"2020-07-24","description":"Emergency medical services (EMS) provide emergency care not only in the urban but also in the remote areas which could be up to 40 minutes from the EMS station. Thus, a cardiac arrest victim in those remote areas has a low likelihood to survive the cardiopulmonary resuscitation. Therefore, we have organized first responders (who are mostly volunteer fire-fighters) in the remote areas and taught them how to perform basic life support (BLS) with use of an automated external defibrillator (AED). In the case of a cardiac arrest the medical dispatcher activates simultaneously the EMS and the first responders, who perform the BLS with the use of an AED before the arrival of EMS. The aim of the study is to analyze and compare the survival of the cardiac arrest victims in remote areas in the time period when the first responders were not organized yet compared to the time period when the first responders were activated to perform BLS.","other_id":"UKC-MB-KME-24/20","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"In the study will be included all adult cardiac arrest victims in the remote areas.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  cardiac arrest in adult victims\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  cardiac arrest in pediatric population\r\n      ","sponsor":"University Medical Centre Maribor","sponsor_type":"Other","conditions":"Cardiac Arrest, Sudden","interventions":[{"intervention_type":"Other","name":"Other: Basic life support witn use of an AED before EMS","description":"BLS performance with use of an AED before arrival of EMS"}],"outcomes":[{"outcome_type":"primary","measure":"Return of spontaneous circulation (ROSC)","time_frame":"5 years","description":"The number of patients who gained the ROSC."},{"outcome_type":"primary","measure":"Survival to hospital discharge","time_frame":"5 years","description":"The number of patients who survived to hospital discharge."},{"outcome_type":"primary","measure":"Neurological outcome","time_frame":"5 years","description":"The number of patients with good neurological outcome assessed with cerebral performance score (CPC 1-2)."},{"outcome_type":"secondary","measure":"Survival till hospital admission","time_frame":"5 years","description":"The number of patients who survived to hospital admission."},{"outcome_type":"secondary","measure":"30 day survival","time_frame":"5 years","description":"The number of patients who survived first 30 days after cardiac arrest."}]}
{"nct_id":"NCT01775332","start_date":"2014-02-28","phase":"N/A","enrollment":60,"brief_title":"Interdisciplinary Pituitary Disorders Centre of Excellence: Assessment of Patient Education Tools","official_title":"Interdisciplinary Pituitary Disorders Centre of Excellence: Assessment of Patient Education Tools","primary_completion_date":"2015-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2015-12-31","last_update":"2015-07-31","description":"The purpose of this research study is to determine the utility of educational materials designed to inform patients of their pituitary condition, in an effort to assist the patients, families, and staff deal with pituitary tumours and related conditions in the best way possible. We have developed a website, informational videos, and a brochure for pituitary tumour patients and their families. The primary outcome measures will be 1) the level of knowledge that patients have of their condition before and after reviewing the materials provided; and 2) ease of use and user satisfaction of the materials. We hypothesize that our informative multimedia educational package will not only improve the health literacy and self-efficacy of patients and their families, but will also improve quality of care.","other_id":"SMHAIF - 058","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  age equal to or greater than 18 years;\r\n\r\n          -  capable of providing consent to participate on their own behalf;\r\n\r\n          -  diagnosed with a pituitary disorder OR have a history of pituitary disorder AND a\r\n             current/former patient at St. Michael's Hospital, OR be a caretaker of someone with a\r\n             pituitary disorder;\r\n\r\n          -  adequate written/verbal English skills.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Younger than 18 years;\r\n\r\n          -  Unable to provide consent;\r\n\r\n          -  Unable to communicate in written/verbal English, as all of the surveys and interviews\r\n             are administered in English\r\n      ","sponsor":"Unity Health Toronto","sponsor_type":"Other","conditions":"Pituitary Neoplasms|Prolactinoma|ACTH-Secreting Pituitary Adenoma|Gigantism|Growth Hormone-Secreting Pituitary Adenoma","interventions":[{"intervention_type":"Other","name":"Other: Educational Intervention","description":"A brochure and access to a website including videos that contain detailed information about pituitary disorders will serve as the educational intervention."}],"outcomes":[{"outcome_type":"primary","measure":"The level of knowledge that patients have of their condition before and after reviewing the materials provided, and ease of use of educational materials and user satisfaction","time_frame":"1-2 yrs"}]}
{"nct_id":"NCT02026401","start_date":"2014-02-28","phase":"Phase 2","enrollment":45,"brief_title":"Phase 2 Study of NGM282 in Patients With Primary Biliary Cirrhosis","official_title":"A Phase 2, Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Center Study to Evaluate the Safety, Tolerability, and Pharmacodynamic Activity of NGM282 in Combination With Ursodeoxycholic Acid (UDCA) Administered for 28 Days in Patients With Primary Biliary Cirrhosis","primary_completion_date":"2014-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-12-31","last_update":"2017-03-28","description":"The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Primary Biliary Cirrhosis.","other_id":"13-0103","allocation":"Randomized","intervention_model":"Factorial Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Males or females, between 18 and 75 years of age, inclusive\r\n\r\n          -  PBC diagnosis consistent with AASLD and EASL guidelines\r\n\r\n          -  Stable dose of UDCA\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Chronic liver disease of a non-PBC etiology\r\n\r\n          -  Evidence of clinically significant hepatic decompensation\r\n      ","sponsor":"NGM Biopharmaceuticals, Inc","sponsor_type":"Industry","conditions":"Primary Biliary Cirrhosis","interventions":[{"intervention_type":"Biological","name":"Biological: Placebo"},{"intervention_type":"Biological","name":"Biological: NGM282"}],"outcomes":[{"outcome_type":"primary","measure":"Absolute change in plasma ALP from Baseline to Day 28","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Absolute change in bilirubin from Baseline to Day 28","time_frame":"28 days"}]}
{"nct_id":"NCT02319850","start_date":"2014-02-28","enrollment":34,"brief_title":"Muscle Ultrasound for Sarcopenia Leading to Early Detection","official_title":"Revisiting the Sarcopenia Diagnosis: New Approaches to Rapid Screening and Preventative Healthcare","primary_completion_date":"2015-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2015-12-31","last_update":"2018-03-01","description":"Sarcopenia is an age-related loss of muscle mass that may affect over 25% of individuals over the age of 60 and results in a 3 to 4 times increased likelihood of developing a disability. Despite these observations, sarcopenia is rarely subject to a systematic screening process as a part of customary geriatric care. Furthermore, when lean body mass (LBM) is measured via dual energy X-ray absorptiometry (DXA) in older adults, it is typically within a reactive, hospital-based, model of healthcare where muscle wasting is only assessed after a loss of functional independence. The investigators propose an affordable, portable screening method with ultrasound imaging to be performed in primary care settings. The investigators long term goal is to identify individuals at risk, and intervene with treatments that may prevent the onset of debilitating loss of muscle function in the elderly.","other_id":"081320","observational_model":"Cohort","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":75,"population":"Enrolled subjects in this pilot study will include a healthy young reference group (18 - 29\r\n        years of age) and an older comparison group (55 - 75 years of age; n = 15 per group;\r\n        approximately 50% female), consecutively recruited from George Washington University and\r\n        the surrounding community.","criteria":"\n        Inclusion Criteria: You are eligible to participate if:\r\n\r\n          1. You are between the ages of 18 - 29 years, or 55 - 75 years.\r\n\r\n          2. You must be able to stand comfortably for 10 minutes and walk a short distance (use of\r\n             assistive devices are acceptable).\r\n\r\n        Exclusion Criteria: You are not eligible to participate if:\r\n\r\n          1. You have a medical condition that results in edema.\r\n\r\n          2. You have had an upper or a lower extremity amputation.\r\n\r\n          3. You are, or may be, pregnant.\r\n\r\n          4. You have a body mass index (BMI) > 30.0.\r\n      ","sponsor":"George Washington University","sponsor_type":"Other","conditions":"Sarcopenia","interventions":[{"intervention_type":"Radiation","name":"Radiation: DXA scanning","description":"Exposure: Participants will undergo DXA scanning in the supine position per manufacturer guidelines to estimate absolute and percentage of total lean body mass (LBM) and body fat (BF)."}],"outcomes":[{"outcome_type":"primary","measure":"Sonographic Lean Body Mass","time_frame":"1 day","description":"US estimates of aggregate regional LBM (muscle thickness, cm), will be assessed using B-mode diagnostic US with a 13-6 megahertz linear array transducer for morphology measures at 5 axial and appendicular sites."},{"outcome_type":"secondary","measure":"DXA lean body mass","time_frame":"1 day","description":"Participants will undergo dual energy X-ray absorptiometry (DXA) scanning in the supine position per manufacturer guidelines to estimate absolute and percentage of total LBM, and body fat percentage (BF%)."},{"outcome_type":"secondary","measure":"Grip strength","time_frame":"1 day","description":"Grip strength will be assessed bilaterally using a isometric dynamometer."},{"outcome_type":"secondary","measure":"Lower extremity function","time_frame":"1 day","description":"A standardized timed sit-to-stand test will be conducted (5 repetitions)."},{"outcome_type":"secondary","measure":"Physical activity questionnaire","time_frame":"1 day","description":"Participants will also complete the International Physical Activity Questionnaire (IPAQ) to obtain an estimate of their customary activity and formal exercise."}]}
{"nct_id":"NCT01907308","start_date":"2014-02-28","phase":"Phase 2","enrollment":0,"brief_title":"Trebananib (AMG 386) in Combination With Docetaxel for Advanced Urothelial Carcinoma","official_title":"A Phase II Single-arm Study of AMG 386 in Combination With Docetaxel for Advanced Urothelial Carcinoma After Failure of a Platinum-containing Regimen","primary_completion_date":"2014-04-30","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2014-04-30","last_update":"2014-04-29","description":"This study plans to learn more about the combination of AMG 386 and docetaxel for the treatment of advanced urothelial cancer. Subjects are being asked to be in this research study because they have advanced urothelial cancer which has progressed after treatment with a platinum-based therapy. The hypothesis is that AMG 386 will increase the historical response rate of docetaxel as a single agent.","other_id":"13-1502.cc","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Subjects must have a histologically confirmed urothelial carcinoma. At least 50% of\r\n             the tumor must demonstrate transitional cell histology.\r\n\r\n          2. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)\r\n             1.1 criteria\r\n\r\n          3. CT or MRI of the chest, abdomen, and pelvis, with or without contrast, within 28 days\r\n             of registration. A whole body bone scan may be performed at the discretion of the\r\n             treating physician.\r\n\r\n          4. Only if clinically indicated, a CT or MRI (MRI preferred) scan of the brain within 28\r\n             days of registration.\r\n\r\n          5. Progressive disease after a platinum-containing regimen (cisplatin or carboplatin) or\r\n             intolerance to platinum-based therapy for urothelial carcinoma. Subjects who received\r\n             adjuvant cisplatin or carboplatin-based chemotherapy for urothelial carcinoma and\r\n             currently have recurrent or progressive disease are eligible.\r\n\r\n          6. Men or women > 18 years old\r\n\r\n          7. Generally well-controlled blood pressure with systolic blood pressure  140 mmHg AND\r\n             diastolic blood pressure  90 mmHg prior to enrolment or randomization. The use of\r\n             anti-hypertensive medications to control hypertension is permitted\r\n\r\n          8. Adequate organ and hematological function as evidenced by the following laboratory\r\n             studies:\r\n\r\n             a. Hematological function, as follows: i. Absolute neutrophil count (ANC)  1.5 x\r\n             109/L ii. Platelet count  100 x 109/L iii. Hemoglobin = 9 g/dL b. Hepatic function,\r\n             as follows: i. Aspartate aminotransferase (AST)  2.5 x upper limit of normal (ULN),\r\n             ii. Alanine aminotransferase (ALT)  2.5 x ULN iii. Alkaline phosphatase  2.0 x ULN\r\n             iv. Total bilirubin within normal limits (WNL) c. Hemostatic function, as follows: i.\r\n             International normalized ratio (INR)  1.5 ii. Activated Partial thromboplastin time\r\n             (aPTT)  1.5 x ULN d. Renal function, as follows: i. Calculated creatinine clearance \r\n             40 cc/min according to the Cockcroft-Gault formula: Creatinine Clearance calculator\r\n             (CrCl) (mL/min) = (140-age) x actual body weight (kg) (x 0.85 for females) 72 x serum\r\n             creatinine (mg/dL) ii. Urinary protein quantitative value of  30 mg in urinalysis or\r\n              1+ on dipstick, unless quantitative protein is  1000 mg in a 24 hour urine sample\r\n             e. Cardiac function, as follows (only in those with a known history of cardiac\r\n             dysfunction or in those with symptoms indicative or cardiac dysfunction): i. Normal\r\n             sinus rhythm or clinically stable arrhythmia well controlled on outpatient medication.\r\n\r\n             ii. Left ventricular ejection fraction  lower limit of normal (LLN) per institutional\r\n             laboratory range, as determined by echocardiogram or multi gated acquisition scan\r\n             (MUGA) scan within 28 days prior to enrollment. If no clear institutional standard,\r\n             then the ejection fraction must be  50%.\r\n\r\n          9. All baseline laboratory results must be from within 14 days of registration\r\n\r\n         10. Competent to comprehend, sign, and date an institutional review board (IRB) - approved\r\n             informed consent form\r\n\r\n         11. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.\r\n\r\n         12. Subject plans to begin protocol-directed therapy within 7 days of registration\r\n\r\n         13. All patients will be offered enrollment in the correlative biomarkers study\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Three or more previous systemic therapies or combination regimens for urothelial\r\n             carcinoma (e.g. cisplatin given with gemcitabine is considered one regimen) in the\r\n             recurrent or metastatic setting.\r\n\r\n          2. Grade 2 or greater neuropathy\r\n\r\n          3. Known history of central nervous system metastases. An MRI or CT scan of the brain\r\n             will be performed within 28 days of study enrollment.\r\n\r\n          4. History of arterial or venous thrombosis, including transient ischemic attack (TIA),\r\n             within 12 months prior to enrollment\r\n\r\n          5. History of clinically significant bleeding within 6 months of study enrollment\r\n\r\n          6. Anticoagulation is allowed as long as the initiating thrombotic event was at least 12\r\n             months before enrollment. The use of aspirin and anti-platelet agents are also\r\n             acceptable for any duration prior to enrollment. The concurrent use of low molecular\r\n             weight heparin, heparinoids, or low dose warfarin (ie, 1 mg daily) for prophylaxis\r\n             against thrombosis is acceptable while on study.\r\n\r\n          7. Subjects with pleural effusions or ascites.\r\n\r\n          8. Focal radiation therapy for palliation of pain from bony metastases within 21 days of\r\n             study enrollment. Subjects who received radiation therapy must have recovered from all\r\n             radiation induced toxicities prior to study enrollment\r\n\r\n          9. Currently or previously treated with AMG 386, or other molecules that inhibit the\r\n             angiopoietins or Tie2 receptor including but not limited to, AZD-5180, XL-820, CEP\r\n             11981/SSR-106462, BSF-466,895, CGI-1842, LOC-590, XL-184, or CP- 8681596. (Previous\r\n             treatment with bevacizumab is permitted.)\r\n\r\n         10. Current or previous treatment with docetaxel. (Previous treatment with paclitaxel is\r\n             permitted.)\r\n\r\n         11. Treatment within 30 days prior to enrollment with strong immune modulators including\r\n             but not limited to systemic cyclosporine, tacrolimus, sirolimus, mycophenolate\r\n             mofetil, methotrexate, azathioprine, rapamycin, thalidomide, lenalidomide.\r\n\r\n         12. Clinically significant cardiovascular disease within 12 months prior to enrollment,\r\n             including myocardial infarction, unstable angina, grade 2 or greater peripheral\r\n             vascular disease, cerebrovascular accident, transient ischemic attack, congestive\r\n             heart failure, or arrhythmias not controlled by outpatient medication\r\n\r\n         13. Major surgery within 28 days before study enrollment or still recovering from prior\r\n             surgery\r\n\r\n         14. Minor surgical procedures, except placement of tunneled central venous access device\r\n             within 3 days prior to enrollment/randomization.\r\n\r\n         15. Non-healing wound, ulcer (including gastrointestinal) or fracture\r\n\r\n         16. Pregnant (i.e., positive beta-human chorionic gonadotropin test) or current breast\r\n             feeding\r\n\r\n         17. Subjects with a history of prior malignancy, except:\r\n\r\n               -  Malignancy treated with curative intent and with no known active disease present\r\n                  for > 3 years before enrollment and felt to be at low risk for recurrence by the\r\n                  treating physician.\r\n\r\n               -  Adequately treated non-melanomatous skin cancer or lentigo maligna without\r\n                  evidence of disease\r\n\r\n               -  Adequately treated cervical carcinoma in situ without evidence of disease\r\n\r\n               -  Prostatic intra-epithelial neoplasia without evidence of prostate cancer\r\n\r\n         18. Subject known to have tested positive for HIV or chronic hepatitis\r\n\r\n         19. Any condition which in the investigator's opinion makes the subject unsuitable for\r\n             study participation\r\n\r\n         20. Female subject not consenting to the use of contraceptive method during the course of\r\n             the study and for 6 months after administration of the last study medication\r\n\r\n         21. Subject currently is enrolled in or has not yet completed at least 30 days since\r\n             ending other investigational device or drug study(s), or subject is receiving other\r\n             investigational agent(s). Alternatively, for any recently administered investigational\r\n             drugs, subjects may start treatment on this protocol after 4 half-lives of the\r\n             previous investigational agent.\r\n\r\n         22. Subject has known sensitivity to any of the products to be administered during dosing\r\n             (including any reaction to drugs formulated with polysorbate 80)\r\n\r\n         23. History of allergic reactions to bacterially produced proteins\r\n\r\n         24. Life expectancy of less than 3 months.\r\n      ","sponsor":"University of Colorado, Denver","sponsor_type":"Other","conditions":"Urothelial Carcinoma","interventions":[{"intervention_type":"Drug","name":"Drug: AMG 386","description":"Patients will receive AMG 386 30mg/kg IV weekly plus docetaxel 75mg/m2 IV every 3 weeks."},{"intervention_type":"Drug","name":"Drug: Docetaxel","description":"Patients will receive AMG 386 30mg/kg IV weekly plus docetaxel 75mg/m2 IV every 3 weeks."}],"outcomes":[{"outcome_type":"primary","measure":"Response rate","time_frame":"Up to 21 days","description":"Determine the objective response rate (by RECIST 1.1 criteria) for the combination of AMG 386 (Trebananib) with docetaxel for the treatment of advanced or metastatic urothelial carcinoma, after failure of a platinum-containing regimen"},{"outcome_type":"secondary","measure":"Overall survival","time_frame":"Up to 24 months","description":"Determine the overall survival for the combination of AMG 386 with docetaxel in advanced or metastatic urothelial carcinoma"}]}
{"nct_id":"NCT01814800","start_date":"2014-02-28","phase":"Phase 3","enrollment":59,"brief_title":"Pharmacokinetics, Efficacy, and Safety Study of RI-002 (IGIV) in Subjects With Primary Immunodeficiency Diseases (PIDD)","official_title":"An Open Label, Multicenter, Study to Evaluate the Pharmacokinetics, Efficacy and Safety of RI-002 (IGIV) in Subjects With Primary Immunodeficiency Diseases (PIDD)","primary_completion_date":"2014-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-01-31","last_update":"2016-10-05","description":"This is a Phase III, multicenter, open-label study of RI-002 administered as an intravenous infusion of RI-002 (IGIV) every 21 or 28 days in approximately 60 subjects with Primary Immunodeficiency Diseases (PIDD).","other_id":"ADMA-003","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":2,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        To be eligible to participate in this study, the subjects must meet the following criteria:\r\n\r\n          1. Signed a written informed consent or a specific assent form for minors.\r\n\r\n          2. Have a diagnosis of primary immunodeficiency disease.\r\n\r\n          3. Be  2 years and  75 years.\r\n\r\n          4. Have body weight  12 kg at screening.\r\n\r\n          5. Have been receiving IGIV at a dose that has not been changed by >50% of the mean dose\r\n             on a mg/kg basis for at least 3 months prior to study entry and have maintained a\r\n             trough serum Immunoglobulin G (IgG) level  500 mg/dL on the previous 2 assessments\r\n             prior to receiving RI 002. The trough level must be at least 300 mg/dL above the\r\n             pre-treatment serum IgG level.\r\n\r\n          6. For female subjects, be of non-childbearing potential or have a negative pregnancy\r\n             test prior to study start and be deemed not at risk of becoming pregnant by adherence\r\n             to a reliable contraceptive method for the duration of the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Subjects must be excluded if they meet any of the following criteria:\r\n\r\n          1. Have a known hypersensitivity to immunoglobulin or any excipient in RI-002.\r\n\r\n          2. Have a history of a severe anaphylactic or anaphylactoid reaction to blood or any\r\n             blood-derived product.\r\n\r\n          3. Have a specific Immunoglobulin A (IgA) deficiency, history of allergic reaction to\r\n             products containing IgA or has demonstrable antibodies to IgA.\r\n\r\n          4. Have uncompensated hemodynamically significant congenital or other heart disease.\r\n\r\n          5. Have a medical condition that is known to cause secondary immune deficiency.\r\n\r\n          6. Have a significant T-cell deficiency or deficiency of granulocyte number or function.\r\n\r\n          7. Have significant renal impairment or have a history of acute renal failure.\r\n\r\n          8. Have abnormal liver function.\r\n\r\n          9. Be receiving chronic anti-coagulation therapy.\r\n\r\n         10. Have a history of deep vein thrombosis (DVT), thrombotic or thrombo-embolic event, or\r\n             are at increased risk for thrombotic events.\r\n\r\n         11. Current daily use of the following medications:\r\n\r\n               -  corticosteroids (> 7.5 mg (or equivalent dose on a mg/kg basis) of prednisone\r\n                  equivalent per day for > 30 days)\r\n\r\n               -  immunomodulatory drugs\r\n\r\n               -  immunosuppressive drugs (excluding topical pimecrolimus (Elidel) and tacrolimus\r\n                  (Protopic))\r\n\r\n         12. Administration of a hyperimmune or specialty high titer immunoglobulin product.\r\n\r\n         13. Have uncontrollable arterial hypertension.\r\n\r\n         14. Have a history of hemolysis or positive Coombs test while undergoing treatment with\r\n             IGIV therapy.\r\n\r\n         15. Be morbidly obese as indicated by a Body Mass Index (BMI)  40\r\n\r\n         16. Have received any blood product (other than Immunoglobulin G) within 3 months prior to\r\n             screening.\r\n\r\n         17. Have received any Respiratory Syncytial Virus (RSV) specific products, including\r\n             palivizumab (Synagis) within 3 months prior to screening.\r\n\r\n         18. Have abused alcohol, opiates, psychotropic agents, or other chemicals or drugs within\r\n             the past 12 months.\r\n\r\n         19. Have any condition or abnormal laboratory assessment judged by the investigator to\r\n             preclude participation in the study.\r\n\r\n         20. Are currently pregnant or nursing.\r\n\r\n         21. Have hepatitis A, B, or C.\r\n      ","sponsor":"ADMA Biologics, Inc.","sponsor_type":"Industry","conditions":"Primary Immune Deficiency Disorder","interventions":[{"intervention_type":"Biological","name":"Biological: RI-002","description":"Immune Globulin Intravenous (IGIV)"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Serious Bacterial Infections (SBIs) Per Subject Per Year (FDA Guidance for Industry (2008))","time_frame":"One year","description":"The primary objective of this study was to demonstrate that RI-002 (IGIV) reduces the frequency of serious bacterial infections (SBIs), as defined by the Diagnostic Criteria for Serious Infection Types guideline, in subjects with primary humoral immunodeficiency."},{"outcome_type":"secondary","measure":"Incidence of All Infections (Serious and Non-serious)","time_frame":"Up to 1 Year"},{"outcome_type":"secondary","measure":"Number of Days Lost From Work/School/Daycare and Usual Activities Due to Infections and Their Treatment - Combined Days Lost","time_frame":"Up to 1 year"},{"outcome_type":"secondary","measure":"Number of Days Lost From Work/School/Daycare and Usual Activities Due to Infections and Their Treatment - Per Subject-Year","time_frame":"Up to 1 year"},{"outcome_type":"secondary","measure":"Number of Unscheduled Visits to Physician/ER Due to Infections - Total Number of Visits","time_frame":"Up to 1 year"},{"outcome_type":"secondary","measure":"Number of Unscheduled Visits to Physician/ER Due to Infections - Per Subject-Year","time_frame":"Up to 1 year"},{"outcome_type":"secondary","measure":"Time to Resolution of Infections - Duration Per Infection","time_frame":"Up to 1 year"},{"outcome_type":"secondary","measure":"Time to Resolution of Infections - Infection Days Per Subject","time_frame":"Up to 1 year"},{"outcome_type":"secondary","measure":"Number of Hospitalizations Due to Infections","time_frame":"Up to 1 year"},{"outcome_type":"secondary","measure":"Number of Hospitalizations Due to Infections - Per Subject-Year","time_frame":"Up to 1 year"},{"outcome_type":"secondary","measure":"Days of Hospitalization Due to Infections","time_frame":"Up to 1 year"},{"outcome_type":"secondary","measure":"Days of Hospitalization Due to Infections - Per Subject-Year","time_frame":"Up to 1 year"},{"outcome_type":"secondary","measure":"Number of Days of Antibiotic Therapy (Prophylaxis and Treatment of Infection)","time_frame":"Up to 1 year","description":"Summary of the days of antibiotic therapy in the study for prophylaxis, as treatment for infections, and combined"},{"outcome_type":"secondary","measure":"Number of Days of Antibiotic Therapy (Prophylaxis and Treatment of Infection) - Per Subject-Year","time_frame":"Up to 1 year","description":"Summary of the days of antibiotic therapy in the study for prophylaxis, as treatment for infections, and combined, per subject-year of treatment with RI-002"},{"outcome_type":"secondary","measure":"Correlation Between Trough Level of RI-002 and Serious and Non-serious Infections","time_frame":"Up to 1 year","description":"The relationship between trough IgG concentrations and the number of infections of any kind/seriousness was evaluated using Pearson linear correlation coefficients using forward analysis (outcomes after infusion) and backward analysis (outcomes prior to infusion; outcomes post last infusion were excluded)"},{"outcome_type":"secondary","measure":"Trough Total IgG and Specific Antibody Levels - IgG","time_frame":"Up to 1 year","description":"Summary of trough total IgG concentration prior to specified infusion"},{"outcome_type":"secondary","measure":"Trough Total IgG and Specific Antibody Levels - Haemophilus Influenzae Type B","time_frame":"Up to 1 year","description":"Summary of trough antibody concentrations prior to specified infusion for Haemophilus influenzae type B"},{"outcome_type":"secondary","measure":"Trough Total IgG and Specific Antibody Levels - Respiratory Syncytial Virus (RSV)","time_frame":"Up to 1 year","description":"Summary of trough antibody concentrations prior to specified infusion for Respiratory Syncytial Virus (RSV)"},{"outcome_type":"secondary","measure":"Trough Total IgG and Specific Antibody Levels - Tetanus","time_frame":"Up to 1 year","description":"Summary of trough antibody concentrations prior to specified infusion for Tetanus"},{"outcome_type":"secondary","measure":"Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 1","time_frame":"Up to 1 year","description":"Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 1"},{"outcome_type":"secondary","measure":"Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 3","time_frame":"Up to 1 year","description":"Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 3"},{"outcome_type":"secondary","measure":"Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 4","time_frame":"Up to 1 year","description":"Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 4"},{"outcome_type":"secondary","measure":"Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 5","time_frame":"Up to 1 year","description":"Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 5"},{"outcome_type":"secondary","measure":"Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 6B","time_frame":"Up to 1 year","description":"Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 6B"},{"outcome_type":"secondary","measure":"Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 7F","time_frame":"Up to 1 year","description":"Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 7F"},{"outcome_type":"secondary","measure":"Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 9V","time_frame":"Up to 1 year","description":"Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 9V"},{"outcome_type":"secondary","measure":"Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 14","time_frame":"Up to 1 year","description":"Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 14"},{"outcome_type":"secondary","measure":"Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 18C","time_frame":"Up to 1 year","description":"Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 18C"},{"outcome_type":"secondary","measure":"Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 19A","time_frame":"Up to 1 year","description":"Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 19A"},{"outcome_type":"secondary","measure":"Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 19F","time_frame":"Up to 1 year","description":"Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 19F"},{"outcome_type":"secondary","measure":"Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 23F","time_frame":"Up to 1 year","description":"Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 23F"}]}
{"nct_id":"NCT01976143","start_date":"2014-02-28","phase":"Phase 1","enrollment":33,"brief_title":"A Study in Cancer Patients to Evaluate the Effect of a Single Dose of NKTR-102 (Etirinotecan Pegol) on the QTc Interval and to Assess Pharmacokinetics and Safety","official_title":"A Phase 1 Study to Evaluate the Effect of Nktr-102 for Injection (Etirinotecan Pegol) on the QT/QTC Interval in Patients With Advanced or Metastatic Solid Tumors","primary_completion_date":"2016-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-09-30","last_update":"2016-12-22","description":"The purpose of this research study is to evaluate the effect of NKTR-102 on the QT/QTc interval in patients with advanced or metastatic solid tumors","other_id":"12-102-12","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Advanced or metastatic solid tumor refractory to standard therapy\r\n\r\n          -  Measurable or non-measurable disease\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\r\n\r\n          -  Resolution of acute toxic effects of prior chemotherapy and other cancer treatments\r\n\r\n          -  Left ventricular ejection fraction (LVEF) 50% by echocardiogram\r\n\r\n          -  Adequate bone morrow and organ function\r\n\r\n          -  Electrolytes within normal limits\r\n\r\n          -  Stopped tobacco use for 4 weeks prior to day 1 and during the study\r\n\r\n          -  Agree to use adequate contraception\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Previous anti-cancer therapy for malignancy within 4 weeks (6 weeks for the\r\n             nitrosoureas or mitomycin C) before day 1\r\n\r\n          -  Treatment with antiarrythmic drugs and any medication known to cause QTc prolongation\r\n             within 4 weeks before screening and during the study\r\n\r\n          -  Prior extensive anthracycline exposure\r\n\r\n          -  Administration of cytochrome P450 CYP3A4 inducers and inhibitors within 4 weeks before\r\n             day 1 and during the study\r\n\r\n          -  Intake of grapefruit, grapefruit juice, Seville oranges, or other products containing\r\n             grapefruit or Seville oranges within 14 days prior to day 1 and during the study\r\n\r\n          -  History of serious cardiovascular disease\r\n\r\n          -  Abnormal systolic blood pressure, diastolic blood pressure and/or heart rate\r\n\r\n          -  History of additional risk factors for Torsade de Pointes\r\n\r\n          -  Prolonged QTcF\r\n\r\n          -  Important abnormalities of the ECG that may interfere with the interpretation of QTc\r\n             interval changes at screening\r\n\r\n          -  Implantable pacemaker or automatic implantable cardioverter defibrillator\r\n\r\n          -  UGT1A1 genotype of TA 7 in both alleles (homozygous UGT1A1*28) or TA 8 in either one\r\n             or both alleles (hetero- or homozygous for UGT1A1*37)\r\n\r\n          -  Any major surgery within 4 weeks prior to day 1\r\n\r\n          -  Concurrent treatment with other anticancer therapy\r\n\r\n          -  Untreated central nervous system metastases\r\n\r\n          -  Chronic or acute GI disorders resulting in diarrhea\r\n\r\n          -  Pregnancy or lactation\r\n      ","sponsor":"Nektar Therapeutics","sponsor_type":"Industry","conditions":"Advanced Cancer|Metastatic Solid Tumors","interventions":[{"intervention_type":"Drug","name":"Drug: NKTR-102"}],"outcomes":[{"outcome_type":"secondary","measure":"Pharmacokinetics (PK) and ECG Parameters","time_frame":"Day 1 through Day 42","description":"1 pre-dose and 18 post-dose blood samples to measure concentrations of NKTR-102 and its metabolites"},{"outcome_type":"primary","measure":"QTcF interval values","time_frame":"Day -1 through Day 42","description":"10 pre-dose and 18 post-dose ECG measurements to evaluate the effect of NKTR-102"}]}
{"nct_id":"NCT02530528","start_date":"2014-02-28","phase":"Phase 1/Phase 2","enrollment":27,"brief_title":"Pilot Trial of Preoperative Chlorhexidine Gluconate (CHG) Skin Preparation","official_title":"Pilot Trial Assessment of the Antimicrobial Efficacy of Medline 2% CHG Cloth Preoperative Skin Preparation","primary_completion_date":"2014-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-04-30","last_update":"2021-04-30","description":"Pilot study to evaluate and compare activity of investigational preoperative preparation (2% CHG) with comparator (2% CHG).","other_id":"R13-042","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":16,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy\r\n\r\n          -  No dermatological conditions\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Sensitivity to CHG\r\n\r\n          -  Sensitivity to natural latex rubber or adhesive skin products\r\n      ","sponsor":"Medline Industries","sponsor_type":"Industry","conditions":"Surgery","interventions":[{"intervention_type":"Drug","name":"Drug: CHG","description":"Varied application times"}],"outcomes":[{"outcome_type":"primary","measure":"Log Reduction of Bacterial Flora on Abdomen and Groin Sites","time_frame":"10 min, 6 hr and 8 hr","description":"Evaluate the Log Reduction of Normal Flora at various sites and timepoints"}]}
{"nct_id":"NCT02960711","start_date":"2014-02-28","phase":"Phase 3","enrollment":2000,"brief_title":"Metformin and Dietary Restriction to Prevent Age-related Morbid Events in People With Metabolic Syndrome","official_title":"Randomized Controlled Trial of Metformin and Dietary Restriction to Prevent Age-related Morbid Events in People With Metabolic Syndrome","primary_completion_date":"2018-07-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2018-07-31","last_update":"2016-11-10","description":"Phase III randomized controlled trial on men and women with Metabolic syndrome (MetS) to test the hypothesis that comprehensive life-style changes and/or metformin treatment prevent age-related chronic non-communicable diseases (ArCD). The aim of the present study is to evaluate the effect of a comprehensive life-style intervention (including moderate physical activity and Mediterranean/macrobiotic diet with moderate calorie and protein restriction), and of treatment with Metformin (a calorie restriction mimetic drug) for the prevention of ArCD.","other_id":"INT 85-13","allocation":"Randomized","intervention_model":"Factorial Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":55,"maximum_age":74,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age 55-74, waist circumference equal or greater than 85 cm for women and 100 cm for\r\n             men, plus at least two other factors among those defining the MetS\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Diagnosed diabetes (or baseline fasting glycemia above 7mmol/L at baseline\r\n             examination)\r\n\r\n          -  Cancer (except skin carcinoma) diagnosed in the last 5 years, or under treatment\r\n\r\n          -  Excessive frailty: in absence of agreed-upon measurements parameters and cutoff\r\n             points, the investigator will exclude subjects under the lower 5th percentile of the\r\n             muscular mass distribution estimated by impedance in previous studies\r\n\r\n          -  Conditions that contraindicate the use of MET because might favour lactic acidosis:\r\n\r\n               -  Renal, cardiac, hepatic, or respiratory insufficiency\r\n\r\n               -  Serum creatinine <124mol/L, or proteinuria at baseline examination\r\n\r\n               -  Current treatment with K-sparing diuretics, or with proton pump inhibitors\r\n\r\n               -  Excessive alcohol consumption\r\n\r\n          -  Distressing side effects of MET treatment. Nausea and diarrhoea typically occur in\r\n             about one third of patients receiving MET for the first time at full dose. To avoid\r\n             dropouts for gastrointestinal discomfort we will treat all volunteers with half the\r\n             planned dose for one month in order to exclude intolerant subjects before\r\n             randomization. Participants randomized in the intervention group will continue to take\r\n             half a dose for one month and then shift to the full dose.\r\n      ","sponsor":"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano","sponsor_type":"Other","conditions":"Metabolic Syndrome","interventions":[{"intervention_type":"Drug","name":"Drug: Metformin Hydrochloride 850 MG Oral Tablet [Glucophage]"},{"intervention_type":"Drug","name":"Drug: Ludipress, mg stereate, micronized hydrated silica, talcum","description":"Tablet"}],"outcomes":[{"outcome_type":"primary","measure":"Total incidence of age related chronic diseases","time_frame":"5 years","description":"We will retrieve records for all Age related chronic diseases but we will first concentrate the analysis on cancer, coronary heart disease, stroke, and diabetes"},{"outcome_type":"secondary","measure":"Effect of the intervention on total mortality and on the incidence of specific chronic diseases.","time_frame":"8-10 years","description":"The measure is a composite outcome measure consisting of multiple measures (results to be reported as a single value for each Arm/Group).\r\nThe outcome measure describes multiple assessments with potentially different Units of Measure as indicated:\r\nWaist circumference: cm Glycemia: mg/dL Blood pressure: mmHg Total cholesterol, HDL cholesterol: mg/dL Triglycerides: mg/dL"}]}
{"nct_id":"NCT02084251","start_date":"2014-02-28","phase":"Phase 1","enrollment":70,"brief_title":"Clinical Trial for PB-119 in Healthy Subjects (Phase I)","official_title":"Safety, Tolerability and Pharmacokinetics of Single Dose of PB-119 in Healthy Volunteers","primary_completion_date":"2014-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-11-30","last_update":"2017-02-14","description":"GLP-1 analogues have been widely used because of their unique advantages (no risk of hypoglycemia) due to their glucose dependent mechanism. Due to the short half-life of peptide in plasma, peptides have to be administered frequently (i.e. BID for Byetta, with Exenatide as API).To improve the patients compliance and reduce potential adverse events associated with GLP-1 analogues, a long acting GLP-1 analogue (PB-119), which may be administered once weekly, was developed by PegBio Inc. In order to provide rational for dosage range to be studied in Phase Ib, the safety profile, tolerance, and pharmacokinetic behavior of PB-119 in healthy subjects will be studied in this randomized, controlled dose escalating trial.","other_id":"ICP-I-2013-08","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female volunteers, ages: between 18-45;\r\n\r\n          -  Body weight female >= 45kg, male >=50kg, BMI >=19-24kg/m2\r\n\r\n          -  Physical examination, blood routine, urine routine, liver and kidney function and\r\n             related laboratory tests are normal or slightly abnormal but not clinically\r\n             significant;\r\n\r\n          -  Read, agree, and sign the informed consent;\r\n\r\n          -  Be able to communicate with the investigator and finish the study according to the\r\n             protocol.\r\n\r\n        Exclusion Criteria anyone or more of the following):\r\n\r\n          -  Allergic to the API or excipients used (citric acid, mannitol, Meta-Cresol);\r\n\r\n          -  Experiencing clinically significant disease or surgery within 4 weeks before the\r\n             study;\r\n\r\n          -  Clinically significant disease history in systems including cardiovascular system,\r\n             endocrine system, neutral system, immunology system, psychiatrymetabolic disorder;\r\n\r\n          -  Disease history of gastrointestinal tract, liver, and kidney (for example, the Partial\r\n             resection surgery in GI tract, liver, or kidney);\r\n\r\n          -  Fever history within 3 days of the screening;\r\n\r\n          -  Clinical significant abnormality found in laboratory tests (blood, urine routine test)\r\n             within 2 weeks before study;\r\n\r\n          -  ECG or vital signs is clinically significant abnormality as judged by the\r\n             Investigator( systolic blood pressure <90mmHg or 140mmHg; diastolic blood\r\n             pressure<60mmHg or 90mmHg; heart rate <50bpm or >100bpm);\r\n\r\n          -  Antibody test for HIV, BsAg, C hepatitis, or Microspironema pallidum positive;\r\n\r\n          -  Alcoholics or drink frequently within 6 months of trial (more than 14 unit of alcohol,\r\n             in which 1 unit is 360mL beers, or 45 ml wine with 40% alcohol content, or 150mL port\r\n             wine;\r\n\r\n          -  Addicted to cigarette, tea, coffee or drugs;\r\n\r\n          -  Have specific requirement for diets (or allergic to any food);\r\n\r\n          -  Have been administered in the past 2 weeks with any drug (such as antibiotics,\r\n             anticoagulant, diuretics) that might interfere the PK profile of drug/drug candidate\r\n             to be used in this study;\r\n\r\n          -  Participated in any clinical trial in the past 3 months;\r\n\r\n          -  Donated blood of more than 360 ml in the past 3 months;\r\n\r\n          -  Plan to be pregnant herself or his spouse in the next 6 months;\r\n\r\n          -  Females administered with any oral contraceptive 30 days before the study or during\r\n             the study;\r\n\r\n          -  Females dosed with long acting estrogen or progestin (injections or implant) 6 months\r\n             before the study or during the study;\r\n\r\n          -  Females at childbearing age that had unprotected intercourse 14 days before the study\r\n             or will have during the study;\r\n\r\n          -  Female who is pregnant or nursing;\r\n\r\n          -  Anybody who might not be able to complete the study, or considered not appropriate by\r\n             the investigator.\r\n      ","sponsor":"PegBio Co., Ltd.","sponsor_type":"Other","conditions":"Type II Diabetes","interventions":[{"intervention_type":"Drug","name":"Drug: PB-119"}],"outcomes":[{"outcome_type":"primary","measure":"Safety/Adverse Event Outcome Measure","time_frame":"Up to 3 weeks"}]}
{"nct_id":"NCT02030483","start_date":"2014-02-28","phase":"Phase 1","enrollment":9,"brief_title":"Palbociclib in Combination With Lenalidomide and Dexamethasone for Multiple Myeloma","official_title":"A Phase 1 Open-Label Study of the Safety and Efficacy of PD 0332991 (Palbociclib) in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma","primary_completion_date":"2016-07-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2016-07-31","last_update":"2018-08-22","description":"Our hypothesis is that treating relapsed or refractory multiple myeloma with PD 0332991 (Palbociclib) in combination with lenalidomide will result will be both effectively inducing myeloma plasma cell death as well maintaining a favorable side effect profile.","other_id":"1306014004","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subject must voluntarily sign and understand written informed consent.\r\n\r\n          -  Subject is 18 years at the time of signing the consent form.\r\n\r\n          -  Subject has histologically confirmed multiple myeloma that expresses phosphorylated\r\n             retinoblastoma protein (pRb), as assessed using a historical biopsy sample if\r\n             available, or a freshly obtained tumor sample.\r\n\r\n          -  Subject has relapsed or refractory myeloma as defined by progression of disease either\r\n             after prior therapy or lack of response to currently used therapy.\r\n\r\n          -  Subject must have received and relapsed or progressed after prior treatment with\r\n             bortezomib.\r\n\r\n          -  Subject has measurable disease as defined by > 0.5 g/dL serum monoclonal protein, >10\r\n             mg/dL involved serum free light chain (either kappa or lambda) provided that the serum\r\n             free light chain ratio is abnormal, >0.2 g/24 hrs urinary M-protein excretion, and/or\r\n             measurable plasmacytoma(s) of at least 1cm in greatest dimension as measured by either\r\n             CT scanning or MRI.\r\n\r\n          -  Subject has a Karnofsky performance status 60% (>50% if due to bony involvement of\r\n             myeloma\r\n\r\n          -  Subject is able to take prophylactic anticoagulation as detailed in section 9.1\r\n             (patients intolerant to aspirin may use warfarin or low molecular weight heparin).\r\n\r\n          -  Subject is registered into the mandatory Revlimid REMSprogram, and is willing and\r\n             able to comply with the requirements of Revlimid REMS program.\r\n\r\n          -  If subject is a female of childbearing potential (FCBP), she must have a negative\r\n             serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14\r\n             days prior to and again within 24 hours of prescribing lenalidomide (prescriptions\r\n             must be filled within 7 days) and must either commit to continued abstinence from\r\n             heterosexual intercourse or begin TWO acceptable methods of birth control, one highly\r\n             effective method and one additional effective method AT THE SAME TIME, at least 28\r\n             days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy\r\n             testing. Men must agree to use a latex condom during sexual contact with females of\r\n             child bearing potential even if they have had a successful vasectomy. Men must agree\r\n             to continue birth control for 90 days post-last dose of PD-0332991\r\n\r\n          -  All study participants must be registered into the mandatory Revlimid REMS program,\r\n             and be willing and able to comply with the requirements of the REMS program.\r\n\r\n          -  Females of reproductive potential must adhere to the scheduled pregnancy testing as\r\n             required in the Revlimid REMS program.\r\n\r\n          -  Subject has a life expectancy  3 months\r\n\r\n          -  Subjects must meet the following laboratory parameters:\r\n\r\n               -  Absolute neutrophil count (ANC) 750 cells/mm3 (1.0 x 109/L)\r\n\r\n               -  Platelet count  75,000/mm3 (75 x 109/L)\r\n\r\n               -  Serum SGOT/AST <3.0 x upper limits of normal (ULN)\r\n\r\n               -  Serum SGPT/ALT <3.0 x upper limits of normal (ULN)\r\n\r\n               -  Serum creatinine clearance, (either calculated or directly measured).  60cc/min\r\n\r\n               -  Serum total bilirubin <2.0 mg/dL (34 mol/L)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subject has immeasurable MM (no measurable monoclonal protein, free light chains in\r\n             blood or urine, or measureable plasmacytoma on radiologic scanning).\r\n\r\n          -  Subject has a prior history of other malignancies unless disease free for  5 years,\r\n             except for basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the\r\n             cervix or breast, or localized prostate cancer with Gleason score < 7 with stable\r\n             prostate specific antigen (PSA) levels.\r\n\r\n          -  Subject has had myocardial infarction within 6 months prior to enrollment , or\r\n             NYHA(New York Hospital Association) Class III or IV heart failure, Ejection Fraction <\r\n             35%, uncontrolled angina, severe uncontrolled ventricular arrhythmias,\r\n             electrocardiographic evidence of acute ischemia or active conduction system\r\n             abnormalities.\r\n\r\n          -  Female subject who is pregnant or lactating.\r\n\r\n          -  Subject has known HIV infection\r\n\r\n          -  Subject has known active hepatitis B or hepatitis C infection.\r\n\r\n          -  Subject has active viral or bacterial infections or any coexisting medical problem\r\n             that would significantly increase the risks of this treatment program.\r\n\r\n          -  Subject has known hypersensitivity to dexamethasone or lenalidomide.\r\n\r\n          -  Subject has a history of thromboembolic event within the past 4 weeks prior to\r\n             enrollment.\r\n\r\n          -  Subject has any clinically significant medical or psychiatric disease or condition\r\n             that, in the Investigator's opinion, may interfere with protocol adherence or a\r\n             subject's ability to give informed consent.\r\n\r\n          -  Any condition, including the presence of laboratory abnormalities, which places the\r\n             subject at unacceptable risk if he/she were to participate in the study or confounds\r\n             the ability to interpret data from the study.\r\n      ","sponsor":"Weill Medical College of Cornell University","sponsor_type":"Other","conditions":"Multiple Myeloma","interventions":[{"intervention_type":"Drug","name":"Drug: Palbociclib","description":"Palbociclb will be given at predefined dose level of 75 mg, 100 mg, 125 mg, or 150 mg days 1-14 every 28 days (days 0-14 for cycle 1 only)."},{"intervention_type":"Drug","name":"Drug: Dexamethasone","description":"20 mg by mouth on days 1, 8, 15 and 22 of a 28-day cycle (Day 1 dosing is omitted for cycle 1 only)."},{"intervention_type":"Drug","name":"Drug: Lenalidomide","description":"Lenalidomide at predefined dose level of 5mg, 10 mg, 15 mg, 25 mg daily for days 8-21 (or days 1-21, depending on dose level cohort)."}],"outcomes":[{"outcome_type":"primary","measure":"Establish a maximum-tolerated dose of Palbociclib, lenalidomide, and dexamethasone for patients with relapsed or refractory multiple myeloma","time_frame":"3 years","description":"The primary endpoint of objective determination of the maximum tolerated dose will be assessed through safety reports. The frequency of subjects experiencing toxicities will be tabulated. Toxicities will be assessed and graded according to CTCAE v. 4.0 terminology"},{"outcome_type":"secondary","measure":"Number of subjects who demonstrate a response to Palbociclib, Lenalidomide, and dexamethasone","time_frame":"3 years","description":"Capture the number of subjects who demonstrate an improvement (response) in myeloma when being treated with palbociclib, lenalidomide, and dexamethasone."},{"outcome_type":"secondary","measure":"Survival duration without disease progression of relapsed/refractory study subjects treated with palbociclib, lenalidomide, and dexamethasone","time_frame":"5 years","description":"Measure the progression-free survival of subjects following treatment with a combination of palbociclib, lenalidomide, and dexamethasone in relapsed or refractory multiple myeloma."},{"outcome_type":"secondary","measure":"Toxicity profile associated with the study regimen (palbociclib, lenalidomide, and dexamethasone)","time_frame":"3 years","description":"Determine the regimen-associated adverse events of the Palbociclib, lenalidomide, and dexamethasone treatment"}]}
{"nct_id":"NCT01948193","start_date":"2014-02-28","phase":"Phase 3","enrollment":177,"brief_title":"Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine in Indian Infants Previously Given a Dose of Hepatitis B Vaccine at Birth","official_title":"Immunogenicity and Safety of Sanofi Pasteur's DTaP-IPV-Hep B-PRP-T Combined Vaccine Given at 6, 10 and 14 Weeks of Age in Infants From India Who Previously Received a Dose of Hepatitis B Vaccine at Birth","primary_completion_date":"2014-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-06-30","last_update":"2015-10-20","description":"The purpose of this study is to describe the immunogenicity and safety of a novel DTaP- IPV- Hep B-PRT~T fully liquid combined hexavalent vaccine (Hexaxim) administered at 6, 10 and 14 weeks of age in infants born to mothers documented to be serum anti-hepatitis B surface antigen (HBsAg) serology negative in India. Primary Objective: - To evaluate the immunogenicity of the study vaccine in terms of seroprotection [diphtheria toxoid, tetanus toxoid, poliovirus types 1, 2 and 3, Haemophilus influenzae type b (Hib) polysaccharide (PRP), hepatitis B (Hep B)] and vaccine response for pertussis antigens [pertussis toxoid (PT) and filamentous haemagglutinin (FHA)] one month after the third dose. Secondary Objectives: - To further describe the immunogenicity of the study vaccine, before the first dose and one month after the third dose. - To describe the safety after each and any doses of the study vaccine.","other_id":"A3L33","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":0.11538,"maximum_age":0.15385,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Aged between 42-56 days (6 to 8 weeks) on the day of inclusion\r\n\r\n          -  Born at full term of pregnancy (37 weeks) and with a birth weight 2.5 kg\r\n\r\n          -  Informed consent form signed by the parent(s) or any other legally acceptable\r\n             representative\r\n\r\n          -  Subject and parent/legally acceptable representative are able to attend all scheduled\r\n             visits and to comply with all trial procedures\r\n\r\n          -  Born to known hepatitis B surface antigen (HBsAg) seronegative mother (documented\r\n             laboratory result of HBsAg assay from maternal blood sample performed during last\r\n             trimester of pregnancy available)\r\n\r\n          -  Have received one documented dose of Hep B vaccine and oral poliovirus vaccine (OPV)\r\n             from birth as per national recommendations.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Participation in another clinical trial in the 4 weeks preceding the trial inclusion\r\n             or planned participation during the present trial period in another clinical trial\r\n             investigating a vaccine, drug, medical device, or medical procedure\r\n\r\n          -  Receipt of any vaccine in the 4 weeks preceding the first trial vaccination (except\r\n             Bacillus Calmette-Guerin [BCG] vaccine) or planned receipt of any other vaccine within\r\n             the period from 8 days before to 8 days after each subsequent trial vaccination\r\n\r\n          -  Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis (expect\r\n             the birth dose of OPV as per national recommendations) and hepatitis B (except the\r\n             birth dose of Hep B vaccine) diseases or Hib infection with the trial vaccine or\r\n             another vaccine\r\n\r\n          -  Past or current receipt of immune globulins, blood or blood-derived products or\r\n             planned administration during the trial\r\n\r\n          -  Known or suspected congenital or acquired immunodeficiency; or receipt of\r\n             immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy since\r\n             birth; or long-term systemic corticosteroid therapy (prednisone or equivalent for more\r\n             than 2 consecutive weeks since birth)\r\n\r\n          -  History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Hib\r\n             infections (confirmed either clinically, serologically or microbiologically)\r\n\r\n          -  Known personal or maternal history of Human Immunodeficiency Virus (HIV) or hepatitis\r\n             C seropositivity\r\n\r\n          -  Known systemic hypersensitivity to any of the vaccine components, or history of a\r\n             life-threatening reaction to the trial vaccine or a vaccine containing the same\r\n             substances\r\n\r\n          -  Known thrombocytopenia, as reported by the parent/legally acceptable representative\r\n\r\n          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,\r\n             contraindicating intramuscular vaccination\r\n\r\n          -  In an emergency setting, or hospitalized involuntarily\r\n\r\n          -  Chronic illness that, in the opinion of the investigator, is at a stage where it might\r\n             interfere with trial conduct or completion\r\n\r\n          -  Moderate or severe acute illness/infection (according to investigator judgment) on the\r\n             day of vaccination or febrile illness (axillary temperature 38C) on the day of\r\n             inclusion (a prospective subject should not be included in the study until the\r\n             condition has resolved or the febrile event has subsided)\r\n\r\n          -  Identified as a natural or adopted child of the Investigator, relatives or employee\r\n             with direct involvement in the proposed study\r\n\r\n          -  History of seizures.\r\n      ","sponsor":"Sanofi Pasteur, a Sanofi Company","sponsor_type":"Industry","conditions":"Diphtheria|Tetanus|Whooping Cough|Hepatitis B|Poliomyelitis|Invasive Hib Infections","interventions":[{"intervention_type":"Biological","name":"Biological: Hexaxim: DTaP-IPV-Hep B-PRP~T combined vaccine","description":"0.5 mL, Intramuscular"}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of Participants With Seroprotection After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth","time_frame":"Pre-dose 1 to one month post-dose 3","description":"Diphtheria antibodies were measured by a toxin neutralization test, tetanus antibodies by an enzyme-linked immunosorbent assay (ELISA), Haemophilus influenzae type b polysaccharide (PRP) antibodies by Farr type radioimmunoassay, poliovirus 1, 2, and 3 antibodies by a neutralization assay, and Hepatitis B (Hep B) antibodies were measured by VITROS ECi/ECiQ Immunodiagnostic System.\r\nDescription of seroprotection: Diphtheria and Tetanus antibody concentrations ≥0.01 International Units (IU)/mL; Poliovirus 1, 2, and 3 titers ≥8 (1/dilution); Hep B concentrations ≥10 mIU/mL, and PRP ≥0.15 µg/mL."},{"outcome_type":"primary","measure":"Percentage of Participants With Vaccine Response After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth","time_frame":"Pre-dose 1 to one month post-dose 3","description":"Anti-pertussis toxin (PT) and anti-filamentous hemagglutinin (FHA) antibodies were measured with an ELISA. Vaccine response was defined as percentage of participants with post-dose 3 anti-PT and anti-FHA antibody concentrations in ELISA units (EU)/mL ≥ 4 x Lower Limit of Quantification (LLOQ) if pre-vaccination concentration was < 4 x LLOQ or ≥ pre-vaccination concentration if pre-vaccination concentrations ≥ 4 x LLOQ."},{"outcome_type":"secondary","measure":"Percentage of Participants With Seroprotection Before and After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth","time_frame":"Pre-dose 1 to one month post-dose 3","description":"Diphtheria antibodies were measured by a toxin neutralization test, tetanus antibodies by an enzyme-linked immunosorbent assay (ELISA), Haemophilus influenzae type b polysaccharide (PRP) antibodies by Farr type radioimmunoassay, poliovirus 1, 2, and 3 antibodies by a neutralization assay, and Hepatitis B (Hep B) antibodies were measured by VITROS ECi/ECiQ Immunodiagnostic System.\r\nDescription of seroprotection: Diphtheria and Tetanus antibody concentrations ≥0.01 International Units (IU)/mL; Poliovirus 1, 2, and 3 titers ≥8 (1/dilution); Hep B concentrations ≥10 mIU/mL, and PRP ≥0.15 µg/mL."},{"outcome_type":"secondary","measure":"Geometric Mean Titers of Antibodies Against Vaccine Antigens After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine After a Documented Dose of an Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth","time_frame":"Pre-dose 1 to one month post-dose 3","description":"Diphtheria antibodies were measured by a toxin neutralization test, tetanus, PT, and FHA antibodies by an ELISA, PRP antibodies by a Farr type radioimmunoassay, poliovirus 1, 2, and 3 antibodies by a neutralization assay, and Hep B antibodies were measured by VITROS ECi/ECiQ Immunodiagnostic System."},{"outcome_type":"secondary","measure":"Geometric Mean Titer Ratios of Antibodies Against Vaccine Antigens After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine After a Documented Dose of Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth","time_frame":"Pre-dose 1 to one month post-dose 3","description":"Diphtheria antibodies were measured by a toxin neutralization test, PT and FHA antibodies by an ELISA, and Hep B antibodies were measured by VITROS ECi/ECiQ Immunodiagnostic System."},{"outcome_type":"secondary","measure":"Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth","time_frame":"Within 7 days after each vaccine injection","description":"Injection-site reactions: Tenderness, Erythema, and Swelling. Systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 Injection site reactions: Tenderness, Cries when injected limb is moved, or reduced movement of injected limb; Erythema and Swelling, ≥50 mm. Grade 3 Systemic reactions: Fever, >39.5°C or >103.1°F; Vomiting, ≥6 episodes/24 hours or requires parenteral hydration; Crying abnormal, >3 hours; Drowsiness, Sleeping most of the time/difficult to wake up; Appetite lost, Refuses ≥3 or most feeds/meals; Irritability, Inconsolable."}]}
{"nct_id":"NCT03622931","start_date":"2014-02-01","phase":"Phase 2","enrollment":21,"brief_title":"Patients With Relapsed Ovarian Cancer (2nd and 3rd Line) Treated With Chemotherapy According to AGO Guidelines","official_title":"Double-blind, Placebo-controlled Multicenter Phase II Trial to Evaluate the Efficacy and Safety of Romiplostim for the Treatment of Chemotherapy-induced Thrombocytopenia in Subjects With Relapsed Ovarian Cancer (2nd or Further Line)","primary_completion_date":"2019-01-01","study_type":"Interventional","rec_status":"Terminated","completion_date":"2019-01-17","last_update":"2021-02-08","description":"To evaluate the safety of secondary chemotherapy induced thrombocytopenia (reduction in platelets which leads to bleeding) prophylaxis with romiplostim in ovarian cancer subjects receiving myelosuppressive (blood cell damaging) chemotherapy.It is anticipated that Romiplostim, when administered at an effective dose and schedule, will be a well-tolerated treatment for subjects experiencing chemotherapy-induced thrombocytopenia.","other_id":"T-RACE II","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","intervention_model_description":"74 patients (about 37 in the experimental and 37 in the placebo arm), evaluable for the principal efficacy endpoint, are required. These will be recruited from an expected number of 15 sites.","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Women  18 years of age\r\n\r\n          -  Before any study-specific procedure, the appropriate written informed consent must be\r\n             obtained, according to ICH-GCP, and national/local regulation\r\n\r\n          -  ANC  1,000/l, Hgb  9.5 g/dl, and platelet count  100 x 109/l on day 1 of the first\r\n             on study cycle of the chemotherapy treatment (on-study cycle) (Thrombocytopenia have\r\n             to be defined during a \"qualifying cycle\"; qualifying cycle could be the 1st or the\r\n             2nd cycle of the palliative chemotherapy; thrombocytopenia as evidenced by a platelet\r\n             count < 50 x 109/l during the qualifying cycle of chemotherapy OR platelet count < 100\r\n             x 109/l on the planned starting day of the next cycle of chemotherapy (or 1-3 days\r\n             before), requiring dose delay for platelet recovery.)\r\n\r\n          -  Subjects with histologically confirmed advanced or metastatic ovarian cancer,\r\n             fallopian tube cancer, peritoneal carcinoma or ovarian carcinosarcoma who are\r\n             receiving 2nd or further line chemotherapy consisting of one of the following regimens\r\n             according to established dosing standards:\r\n\r\n               1. Topotecan, d 1-5, q3w\r\n\r\n               2. Gemcitabine, d1+8, q3w\r\n\r\n               3. Carboplatin / paclitaxel, d1, q3w\r\n\r\n               4. Carboplatin d1 /gemcitabine, d1+d8, q3w\r\n\r\n               5. Carboplatin / pegylated liposomal doxorubicin, d1, q4w\r\n\r\n               6. Carboplatin d1 / gemcitabine, d1+d8, Avastin d1, q3w\r\n\r\n               7. Topotecan d1-5 + avastin, q3w\r\n\r\n               8. Carboplatin + paclitaxel + avastin, q3w\r\n\r\n          -  Thrombocytopenia as evidenced by a platelet count < 50 x 109/l during the qualifying\r\n             cycle of chemotherapy OR platelet count < 100 x 109/l on the planned starting day of\r\n             the next cycle of chemotherapy (or 1-3 days before), requiring dose delay for platelet\r\n             recovery; qualifying cycle could be the 1st or the 2nd cycle of chemotherapy\r\n\r\n          -  Life expectancy  12 weeks at the time of screening\r\n\r\n          -  Ability to receive the same dose and schedule of chemotherapy during the first on\r\n             study treatment cycle as was given in the qualifying cycle(s). (In case of grade 4\r\n             thrombocytopenia: a dose reduction to 75% of the previous dose schedule is allowed.)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Previous treatment with PEG-rHuMGDF, recombinant human thrombopoietin (rHuTPO),\r\n             romiplostim, eltrombopag, or another thrombopoietic protein\r\n\r\n          -  Past or current history of malignancies that affect the overall prognosis (Please\r\n             note: patients with past or current malignancies not affecting the overall prognosis\r\n             are allowed for enrollment)\r\n\r\n          -  Subjects, who have had a larger surgery within the last 2 weeks before entering this\r\n             study\r\n\r\n          -  Active participation in any other clinical study\r\n\r\n          -  Subjects with an active infection; sepsis, disseminated intravascular coagulation, or\r\n             any other condition (i.e. myelodysplastic syndrome {MDS}, immune thrombocytopenic\r\n             purpura {ITP}, thrombotic thrombocytopenic purpura {TTP}, hemolytic uremic syndrome\r\n             {HUS}) that may have exacerbated thrombocytopenia\r\n\r\n          -  History of unstable angina, CHF {NYHA >class II}, uncontrolled hypertension {diastolic\r\n             >100mm HG}, uncontrolled cardiac arrhythmia, or recent (within 1 year of screening)\r\n             myocardial infarction (MI)\r\n\r\n          -  History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 1\r\n             year of screening\r\n\r\n          -  History of pulmonary embolism or other venous thrombosis within 1 year of screening\r\n             (except for catheter-related clots)\r\n\r\n          -  Receipt of any experimental therapy within the last 4 weeks prior to screening;\r\n             subject is currently enrolled in, or has completed within the last 30 days, another\r\n             investigational device or drug study (exception: PROVE study)\r\n\r\n          -  Receipt of a bone marrow or peripheral blood stem cell infusion (within 1 year of\r\n             screening)\r\n\r\n          -  Positive Pregnancy test\r\n\r\n          -  breast feeding period\r\n\r\n          -  Reproductive potential and not using adequate highly effective methods of\r\n             contraceptive precautions in the judgment of the investigator during treatment and for\r\n             6 month (male or female) after the end of treatment (adequate: oral contraceptives,\r\n             intrauterine device or barrier method in conjunction with spermicidial jelly)\r\n\r\n          -  Known hypersensitivity to any recombinant E. Coli-derived product or any additives\r\n\r\n          -  Inability to comply with the protocol or missing written informed consent\r\n\r\n          -  Any psychological, familial, sociological or geographical condition potentially\r\n             hampering compliance with the study protocol and follow-up schedule; those conditions\r\n             should be discussed with the subject before registration in the trial.\r\n\r\n          -  Accommodation in an institution due to official or legal orders (40 p.1 No. 4 AMG)\r\n      ","sponsor":"Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH","sponsor_type":"Other","conditions":"Ovarian Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Standard chemotherapy","description":"Chemotherapy"},{"intervention_type":"Drug","name":"Drug: Romiplostim"},{"intervention_type":"Drug","name":"Drug: Placebos"}],"outcomes":[{"outcome_type":"primary","measure":"Grade 3 and 4 thrombocytopenia","time_frame":"At the end of Cycle 1 (each cycle is 28 days)","description":"Platelet Count (100 x 10^9/L) will be measured and the rate will be compared by Treatment Group"},{"outcome_type":"secondary","measure":"Adverse events of grade 3/4","time_frame":"At the end of Cycle 4 (each cycle is 28 days)","description":"Determine the rate of AE between the experimental arm and the placebo arm."},{"outcome_type":"secondary","measure":"Grade 3/4 thrombocytopenia","time_frame":"on days 8, 11 or 12, 15","description":"The rate of AE between the experimental arm and the placebo arm will be determined"},{"outcome_type":"secondary","measure":"Platelet Counts","time_frame":"on days 8, 11 or 12, 15","description":"The average platelet nadir in each treatment Group will be considered"},{"outcome_type":"secondary","measure":"Bleeding events","time_frame":"At the end of Cycle 8 (each cycle is 28 days)","description":"The proportion of patients suffering from grade 1, 2, 3, or 4 bleeding Events will be considered"},{"outcome_type":"secondary","measure":"Grade 1, 2, 3, or 4 thrombocytopenia (maximum NCI CTC grade by patient)","time_frame":"At the end of Cycle 8 (each cycle is 28 days)","description":"Determine the proportion of subjects in each treatment group"},{"outcome_type":"secondary","measure":"Grade 3/4 thrombocytopenia","time_frame":"At the end of Cycle 8 (each cycle is 28 days)","description":"The duration will be considered"},{"outcome_type":"secondary","measure":"Platelet transfusions","time_frame":"At the end of Cycle 8 (each cycle is 28 days)","description":"The number of subjects in each treatment Group will be considered"},{"outcome_type":"secondary","measure":"Platelet counts","time_frame":"On day 22 of each Cycle till max. 8 Cycles (each cycle is 28 days)","description":"The platelet counts on study chemotherapy treatment cycles by treatment group will be considered."},{"outcome_type":"secondary","measure":"Counts of CT cycles","time_frame":"through study completion, an average of 8 month","description":"The proportion of subjects able to receive all CT cycles on time by treatment group"},{"outcome_type":"secondary","measure":"ADR/SADR of romiplostim","time_frame":"through study completion, an average of 8 month","description":"Assess the reported ADR/SADR"}]}
{"nct_id":"NCT02531529","start_date":"2014-01-31","phase":"N/A","enrollment":70,"brief_title":"Dexmedetomedine Infusion Versus Fentanyl Infusion for Donor Anlgesia During Living Donor Hepatectomy","primary_completion_date":"2015-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-04-30","last_update":"2015-08-24","description":"To compare between the analgesic effect of dexmedetomedine infusion versus Fentanyl infusion during donor hepatectomy.","other_id":"LTx 1","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  donors of living donor liver transplantation\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  patient refusal Known allergy to dexmedetomedine\r\n      ","sponsor":"Mansoura University","sponsor_type":"Other","conditions":"Donor Hepatectomy","interventions":[{"intervention_type":"Drug","name":"Drug: dexmedetomedine","description":"intraoperative infusion"},{"intervention_type":"Drug","name":"Drug: Fentanyl"}],"outcomes":[{"outcome_type":"primary","measure":"postoperative VAS scale","time_frame":"3 days"}]}
{"nct_id":"NCT02185976","start_date":"2014-01-31","phase":"N/A","enrollment":60,"brief_title":"Effect of Cartoons on Preoperative Anxiety in Paediatric Patients.","official_title":"Preoperative Anxiety in Paediatric Patients; do Cartoons Help?","primary_completion_date":"2020-08-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2020-12-31","last_update":"2020-01-21","description":"Preoperative Anxiety is a major problem in anesthesia management. Paediatric patients are a special group who need special attention. Some studies have shown that cartoons are a very good tool for distraction in the preoperative period for children. Our hypothesis is that children watching Cartoons in the preoperative period will have less anxiety and will be fit with preparation.","other_id":"2013/051","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Other","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":3,"maximum_age":9,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  family approval\r\n\r\n          -  age between 3-9\r\n\r\n          -  scheduled for surgery under general anesthesia\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  history of physiatric disease\r\n\r\n          -  regular medication\r\n\r\n          -  previous history of anesthesia/sedation\r\n      ","sponsor":"Balikesir University","sponsor_type":"Other","conditions":"Anxiety","interventions":[{"intervention_type":"Other","name":"Other: cartoon","description":"5 different cartoons which will be recorded on a tablet PC."}],"outcomes":[{"outcome_type":"secondary","measure":"family anxiety scores","time_frame":"Before operation during the first examination","description":"the anxiety score of the parents is going to be evaluated before the operation."},{"outcome_type":"primary","measure":"anxiety score","time_frame":"at the beginning and before induction of anesthesia","description":"the anxiety score of included patients is going to be evaluated at the beginning in the preparation room and once again in the operation room before induction."}]}
{"nct_id":"NCT02212665","start_date":"2014-01-31","phase":"N/A","enrollment":59,"brief_title":"Life Without Diabetes","official_title":"Life Without Diabetes","primary_completion_date":"2017-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-12-31","last_update":"2021-07-09","description":"The aim of the study 'Live - without diabetes' is to investigate the effects of increased physical activity on a daily basis with or without (high intense interval training) HIIT (short and intense: 3 minutes per week) during 12 weeks in risk individuals with pre-diabetes","other_id":"H-4-2013-079","allocation":"Randomized","intervention_model":"Factorial Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Body mass index (BMI) > 25 kg/m2\r\n\r\n          -  Prediabetes: 6.1 %  glycated hemoglobin A1c (HbA1c)  6.4 % and / or increased\r\n             fasting plasma glucose (FPG): 6.1 mM  FPG  6.9 mM and / or abnormal glucose\r\n             tolerance (7.8 mM  2 hour plasma glucose (PG)  11.0 mmol)\r\n\r\n          -  Weekly training status <150 minutes\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  BMI <25 kg/m2\r\n\r\n          -  Diabetes\r\n\r\n          -  Pregnancy and breastfeeding\r\n\r\n          -  Treatment with medicine, there influence glucose metabolism\r\n\r\n          -  Decreased liver function (liver transaminases > 3 times of limit of normal)\r\n      ","sponsor":"University Hospital, Gentofte, Copenhagen","sponsor_type":"Other","conditions":"Prevention of Developing Type 2 Diabetes","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Increased daily activity detected by the pedometer"},{"intervention_type":"Behavioral","name":"Behavioral: High intense interval training"},{"intervention_type":"Behavioral","name":"Behavioral: Increased daily activity detected by the pedometer+HIIT"},{"intervention_type":"Behavioral","name":"Behavioral: Increased daily activity detected by the pedometer+group intervention"}],"outcomes":[{"outcome_type":"secondary","measure":"Changes in key proteins in glucose and fat metabolism (Adipose fat tissure)","time_frame":"At baseline and after 12 weeks","description":"Expression/content of key proteins in adipose tissue (AU units)"},{"outcome_type":"primary","measure":"Changes in insulin sensitivity","time_frame":"At baseline and after 12 weeks","description":"The primary endpoint is insulin sensitivity, and it will be assessed by changes in the area under the curve from baseline to end-of-study assessed by the Cederholm Index and Matsuda Index"},{"outcome_type":"secondary","measure":"Changes in oxygen peak oxygen uptake","time_frame":"At baseline and after 12 weeks","description":"Assessed from a physical fitness test (VO2peak)"},{"outcome_type":"secondary","measure":"Changes in glycaemic control","time_frame":"At baseline and after 12 weeks","description":"Measured as fasting plasma glucose, HbA1c"},{"outcome_type":"secondary","measure":"Changes in key proteins in glucose and fat metabolism (Skeletal muscle)","time_frame":"At baseline and after 12 weeks","description":"Expression/content of key proteins in skeletal muscle tissure (AU units)"},{"outcome_type":"secondary","measure":"Changes in body weight (kg)","time_frame":"At baseline and after 12 weeks","description":"Measured by Dual-energy X-ray Absorptiometry, DXA"},{"outcome_type":"secondary","measure":"Patient-reported outcome measure","time_frame":"At baseline and after 12 weeks","description":"Health related quality of life measured from Short Form 36 (SF36). Where scores are presented as norm-based scores (0-100) with higher scores indicating better perceived health status."}]}
{"nct_id":"NCT02518282","start_date":"2014-01-31","enrollment":800,"brief_title":"High-sensitivity Troponin T in Acute Myocardial Infarction After Cardiac Valvular Surgery","official_title":"High-sensitivity Troponin T in Acute Myocardial Infarction in Patients Undergoing Cardiac Valvular Surgery","primary_completion_date":"2016-04-30","study_type":"Observational","rec_status":"Unknown status","completion_date":"2016-05-31","last_update":"2015-08-17","description":"A measurable degree of heart muscle tissue injury is expected in patients undergoing heart valvular surgery. The level of this injury can be measured by cardiac biomarkers in blood samples. Those biomarkers are used to diagnose an acute myocardial infarction. Postoperative myocardial infarction (MI) is a frequent and important complication after cardiac surgery with high morbidity and mortality. Therefore it is very important to recognize any cardiac event in patients who undergo cardiac surgery. Different diagnostic tools can be used to the diagnosis of acute myocardial infarction; however few is known about the value of high-sensitivity cardiac troponin T (hs-cTn) to diagnose a MI after heart valvular surgery. The aim of this study is to determine the upper reference limit of high-sensitivity troponin T concentration to consider the diagnosis of acute myocardial infarction in patients undergoing heart valvular surgery.","other_id":"PI 15-223 CINV 15-01","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"Adult patients (over 18 years old) undergoing heart valvular surgery with CPB.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Each participant must be older than 18 years.\r\n\r\n          -  Undergoing cardiac valvular surgery.\r\n\r\n          -  No recent clinical history of ischemic heart disease.\r\n\r\n          -  Each participant must voluntarily give his written informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients undergoing coronary bypass artery grafting (CABG).\r\n\r\n          -  Patients with severe or end-stage renal insufficiency.\r\n\r\n          -  Insertion of assist devices.\r\n      ","sponsor":"University of Valladolid","sponsor_type":"Other","conditions":"Acute Myocardial Infarction|Disorder; Heart, Functional, Postoperative, Cardiac Surgery|Myocardial Infarction|Heart Valve Diseases","interventions":[{"intervention_type":"Other","name":"Other: Serum levels of high-sensitivity troponin T","description":"Serum levels of hs-cTn will be measured before surgery, upon arrival at the ICU, as well as every 6 hours for 24 hours, then every 8 hours the following 24 hours and a last blood sample will be taken 72 hours after surgery."},{"intervention_type":"Other","name":"Other: Twelve-lead ECGs","description":"Twelve-lead ECGs obtained the day prior to heart valvular surgery, immediately upon arrival at the ICU, and then 24, 48 and 72 hours post-surgery will be reviewed by a cardiologist to evidence signs of MI."},{"intervention_type":"Other","name":"Other: Transthoracic echocardiography (TTE)","description":"A TTE will be also performed by a cardiologist after cardiac valvular surgery to determine the ejection fraction of left ventricle and the occurrence of a new regional wall motion abnormality. This TTE will be compared, by the same cardiologist, with a TTE performed before cardiac valvular surgery."}],"outcomes":[{"outcome_type":"primary","measure":"Determination of upper reference limit (URL) of high-sensitivity troponin T that strongly suggests substantial myocardial damage and necrosis.","time_frame":"Every 6 postoperative hours for the first 24 hours, then every 8 hours the following 24 hours and a last sample will be taken 72 hours after heart valvular surgery.","description":"Postoperative MI remains a frequent complication after cardiac surgery with high morbidity and mortality. In 2012 the Third Global MI Task Force presented the third universal definition of MI implying that MI associated with coronary artery bypass grafting (CABG) is arbitrarily defined by elevation of cardiac biomarkers values over 10 x 99th percentile URL in patients with normal baseline cTn values. In addition with either: a) new pathological Q waves or new left bundle branch block (LBBB), or b) angiographic documented new graft or new native coronary artery occlusion, or c) imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. Few is known about the established threshold values for hs-cTn after heart valvular surgery."},{"outcome_type":"secondary","measure":"High-sensitivity troponin T concentration changes over time in patients undergoing heart valvular surgery","time_frame":"From 8 hours preoperatively to 72 hours postoperatively","description":"Serum levels of hs-cTn will be measured before cardiac surgery, upon arrival at the ICU, as well as every 6 hours for 24 hours, then every 8 hours the following 24 hours and a last blood sample will be taken 72 hours after heart valvular surgery."},{"outcome_type":"secondary","measure":"Number of patients with complications after heart valvular surgery.","time_frame":"After cardiac valvular surgery to 72 hours post-surgery.","description":"To determine the number of patients with complications after heart valvular surgery and to determine which are the most frequent complications in patients undergoing cardiac valvular surgery."},{"outcome_type":"other","measure":"Twelve-lead ECGs.","time_frame":"The day prior to cardiac surgery, immediately upon arrival at the ICU, and then 24, 48 and 72 hours post-surgery.","description":"Twelve-lead ECGs will be reviewed by a cardiologist to evidence signs of postoperative MI."},{"outcome_type":"other","measure":"Transthoracic Echocardiography (TTE).","time_frame":"Before heart valvular surgery and after heart valvular surgery.","description":"A TTE will be performed after heart valvular surgery to evidence a new regional wall motion abnormality. This TTE will be compared with a TTE performed before surgery."}]}
{"nct_id":"NCT01979692","start_date":"2014-01-31","phase":"N/A","enrollment":10,"brief_title":"Feasibility of Confocal Laser Microscopy (CLM)in the Computed Tomography-guided Needle Biopsy of Pulmonary and Mediastinal Lesions","official_title":"Feasibility of Confocal Laser Microscopy CLM in the Computed Tomography-guided Needle Biopsy of Pulmonary and Mediastinal Lesions","primary_completion_date":"2015-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2015-12-31","last_update":"2014-05-13","description":"The hypothesis of this proposal is that needle confocal laser microscopy (nCLM) may improve the yield of trans thoracic needle biopsy (TTNB) of lung or mediastinal lesions by differentiating between viable and necrotic tissue. This may reduce the number of biopsy attempts and eventually the complication rate of the procedure.","other_id":"SHEBA-13-0526-ST-CTIL","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  patients aged between 18 and 80 referred for TTNB due to lung or mediastinal lesions.\r\n             Both genders will be enrolled with new diagnosed mediastinal or lung masses by chest\r\n             imaging (chest radiography or computed tomographyCT)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  known allergy to anesthetic medication, known allergy to fluorescein, inability to lie\r\n             on the CT bed examination or cardiovascular instability as decided by the principal\r\n             investigator.Pregnant women' children or debilitated patients will not be included\r\n      ","sponsor":"Sheba Medical Center","sponsor_type":"Other","conditions":"Pulmonary and Mediastinal Lesions","interventions":[{"intervention_type":"Procedure","name":"Procedure: confocal laser microscopy CLM at trans thoracic needle biopsy TTNB"},{"intervention_type":"Device","name":"Device: CT guided trans thoracic needle biopsy"}],"outcomes":[{"outcome_type":"primary","measure":"The presence of viable tissue at CLM as a marker of accurate histological diagnosis","time_frame":"24 months","description":"The presence of necrotic tissue in lung or mediastinal biopsies impare the quality of histological diagnosis. CLM may help in distinguishing between viable and necrotic tissue in real time."}]}
{"nct_id":"NCT02315404","start_date":"2014-01-31","phase":"N/A","enrollment":87,"brief_title":"Cap Assisted Balloon Enteroscopy Versus Conventional Balloon Enteroscopy In The Evaluation Of Obscure Gastrointestinal Bleeding: A Randomized Controlled Trial","official_title":"Cap Assisted Balloon Enteroscopy Versus Conventional Balloon Enteroscopy In The Evaluation Of Obscure Gastrointestinal Bleeding: A Randomized Controlled Trial","primary_completion_date":"2017-05-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2017-05-31","last_update":"2018-06-25","description":"Gastrointestinal bleeding originating from the small bowel is difficult to diagnose and treat because the small bowel is difficult to see and reach. Balloon assisted enteroscopy (BAE) is a new enteroscopy methods that allow examination of the small bowel and allows for diagnosis and treatment of bleeding originating from this part of the intestine. Unfortunately, BAE is unsuccessful in identifying the cause of bleeding in 40-50% of patients. This may be due to limited visualization of the small bowel lining during conventional endoscopy. One way to improve visualization of the small bowel lining is by adding a transparent plastic cap to the end of the endoscope (camera), which allows the endoscope to see around sharp turned and behind folds in the small bowel. The investigators goal in this randomized controlled study is to see if adding a transparent cap to the end of the endoscope will help to identify and treat small bowel bleeding. The investigators will invite patients referred for BAE to participate in the study; the alternative to participating in the study is having standard BAE (without a cap). If patients choose to participate in the study they will be randomized to BAE with or without a cap on the end of the endoscope. Subjects time commitment will be limited to the consent process and pre-procedure paperwork at time of initial endoscopy and time required to complete telephone questionnaire at 12 months follow up.","other_id":"SBE CAP 1","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Diagnostic","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":95,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adult (18 years old) patients undergoing BAE for the evaluation of OGIB or iron\r\n             deficiency anemia.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Unable to provide written informed consent.\r\n\r\n          -  Pregnancy or lactation.\r\n\r\n          -  Suspected bowel obstruction or GI perforation.\r\n\r\n          -  Unable to tolerate sedation or general anesthesia due to medical co-morbidities.\r\n\r\n          -  Uncorrected coagulopathy (platelet count <50,000, INR> 2, PTT> 2x upper limit of\r\n             normal).\r\n\r\n          -  Patient undergoing retrograde BAE.\r\n      ","sponsor":"Washington University School of Medicine","sponsor_type":"Other","conditions":"Obscure Gastrointestinal Bleeding","interventions":[{"intervention_type":"Procedure","name":"Procedure: CAP","description":"CAP fitted to the end of the endoscope"}],"outcomes":[{"outcome_type":"primary","measure":"Diagnostic yield of BAE vs. Cap assisted BAE (C-BAE).","time_frame":"1 day","description":"Diagnostic yield defined as proportion of enteroscopies in which clinically significant findings were identified.\r\na. Clinically significant findings being defined as P2 lesion (lesion considered to have high potential for bleeding; such as typical angiomata, large ulceration, tumor or varices)"},{"outcome_type":"secondary","measure":"Overall Diagnostic yield of BAE vs. C-BAE","time_frame":"1 day","description":"Diagnostic yield defined as proportion of enteroscopies in which any abnormality is detected.\r\na. Abnormalities classified as: i. P0: lesion with no bleeding potential, including visible submucosal veins, diverticula without the presence of blood or nodules without mucosal break.\r\nii. P1: lesion considered as having uncertain bleeding potential, such as a red spot on the intestinal mucosa or small erosions.\r\niii. P2: lesion considered to have high potential for bleeding; such as typical angiomata, large ulceration, tumor or varices"},{"outcome_type":"secondary","measure":"Therapeutic yield BAE vs. Cap assisted BAE (C-BAE).","time_frame":"1 day","description":"Therapeutic yield being defined as proportion of enteroscopies in which a therapeutic intervention was undertaken. Interventions included in this calculation were polypectomy, argon plasma coagulation, bipolar coagulation, dilation of strictures, and endoscopic clipping. Biopsy was considered to be a therapeutic intervention if histopathology results lead to the initiation of a medical or surgical therapy (i.e: resection of mass, medical therapy for Crohn's disease)"},{"outcome_type":"secondary","measure":"iii. Depth of small bowel insertion: calculated according to the method of Efthymiou et al.","time_frame":"1 day","description":"Fold counting method: The number of complete folds (valvulae conniventes) will be counted during withdrawal of the endoscope; with the assumption that the distance between folds is approximately 0.9 cm."},{"outcome_type":"secondary","measure":"vProcedure related adverse events.","time_frame":"1 day"},{"outcome_type":"secondary","measure":"Recurrence of GI bleeding at 12 months, as evaluated by questionnaire","time_frame":"12 months"}]}
{"nct_id":"NCT02061111","start_date":"2014-01-31","enrollment":77,"brief_title":"NeoThyr - the Role of Mitochondria-dysfunction in Newborns of Mothers With Autoimmune Thyroid Disease","official_title":"NeoThyr - the Role of Mitochondria-dysfunction in Newborns of Mothers With Autoimmune Thyroid Disease","primary_completion_date":"2017-12-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2019-11-30","last_update":"2019-09-24","description":"Previously, studies have shown that children of women with thyroid autoantibodies experience more birth complications and poorer health in their first days. Studies have also shown later signs of cognitive developmental challenges (risk of attention deficit/hyperactivity problems) among children of mothers with autoimmune thyroid disease and/or subclinical hypothyroidism. In Denmark there is no formalized screening or treatment of subclinical thyroid disease - with or without Thyroid Peroxidase Antibodies (TPO-antibodies) - among pregnant women. The hypothesis of this study is that the offspring of women with subclinical thyroid disease have a mitochondria-dysfunction which leads to more complications during birth, poorer health and well-being in the early childhood. The investigators will test this by recruiting mothers by a blood sample in the third trimester of pregnancy, screen the cord blood at birth and later on test the children with Bayley test two times in the early childhood.","other_id":"SJ-361","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"Female","minimum_age":18,"maximum_age":50,"population":"The study population will be selected among pregnant women in region Zealand that will give\r\n        birth by cesarean section","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Singleton pregnancy, clinically healthy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Twin-pregnancy, metabolic disorder, medication or other diseases with a potential\r\n             adverse impact on the pregnancy and fetus\r\n      ","sponsor":"Naestved Hospital","sponsor_type":"Other","conditions":"Subclinical Hypothyroidism|Autoimmune Thyroid Disease|Alteration of Mitochondrial Membrane","interventions":{},"outcomes":[{"outcome_type":"secondary","measure":"Head circumference (cm)","time_frame":"Age 0-15 months","description":"Differences between the two groups"},{"outcome_type":"secondary","measure":"Motor development","time_frame":"Age 6 and15 months","description":"Differences between the two groups, evaluated by Bayley test"},{"outcome_type":"secondary","measure":"Cognitive development","time_frame":"Age 6 and 15 months","description":"Differences between the two groups, evaluated by Bayley test"},{"outcome_type":"secondary","measure":"Language","time_frame":"Age 6 and 15 months","description":"Differences between the two groups, evaluated by Bayley test"},{"outcome_type":"secondary","measure":"Birth complications","time_frame":"Birth","description":"Number of birth complications in the two groups in terms of postpartum hemorrhage >=500 ml"},{"outcome_type":"secondary","measure":"Length (cm)","time_frame":"Age 0-15 months","description":"Differences between the two groups"},{"outcome_type":"primary","measure":"Mitochondrial function","time_frame":"Delivery","description":"Maternal and cord blood. Analyses will be run by flow cytometry and qPCR"},{"outcome_type":"secondary","measure":"Perinatal complications","time_frame":"At birth","description":"Number of children in each group with abnormal apgar score, cord pH, need of CPAP, resuscitation, low blood sugar, cramps, death"},{"outcome_type":"secondary","measure":"Well-being","time_frame":"Age 0-15 months","description":"Number of children in each group that have been admitted to the hospital due to icterus or metabolic disease"},{"outcome_type":"secondary","measure":"Weight (kg)","time_frame":"Age 0-15 months","description":"Differences between the two groups"},{"outcome_type":"secondary","measure":"Social/emotional behavior","time_frame":"Age 12 months","description":"Differences between the two groups, evaluated by ASQ:SE"}]}
{"nct_id":"NCT02081053","start_date":"2014-01-31","phase":"N/A","enrollment":30,"brief_title":"Evaluating Clinical Outcomes of Targeted Radiofrequency Ablation and Kyphoplasty (Also Known as Vertebral Augmentation) to Treat Painful Metastatic Vertebral Body Tumors","official_title":"A Prospective, Multicenter Clinical Study to Evaluate the Clinical Outcomes of Targeted Radiofrequency Ablation and Vertebral Augmentation to Treat Painful Metastatic Vertebral Body Tumor(s)","primary_completion_date":"2016-11-30","study_type":"Interventional","rec_status":"Terminated","completion_date":"2016-11-30","last_update":"2017-01-20","description":"To evaluate the clinical outcomes of minimally invasive targeted radiofrequency tumor ablation (t-RFA) and kyphoplasty (also known as vertebral augmentation) in painful metastatic lesions in the spine.","other_id":"DF-13-03","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  One to 2 painful vertebrae (T1-L5) with evidence of osteolytic metastatic lesion with\r\n             known primary histology with pathologic fracture(s) at index vertebra by MRI\r\n\r\n          -  Pain score  4 on the numerical rating pain scale\r\n\r\n          -  Life expectancy of  6 months\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Primary tumors of the bone at index vertebra\r\n\r\n          -  Benign tumors of the bone at index vertebra\r\n\r\n          -  Osteoblastic tumors at index vertebra\r\n\r\n          -  Index vertebra with more than one (1) pedicle involved\r\n\r\n          -  Epidural extension of tumor within 5 mm of the spinal cord or without sufficient room\r\n             for thermal protective maneuvers\r\n\r\n          -  Spinal cord compression or canal compromise requiring decompression\r\n\r\n          -  Radiation therapy is planned to be started on the index vertebra within 4 weeks post\r\n             procedure\r\n\r\n          -  Radiation therapy was performed on the index vertebra within 2 months before\r\n             enrollment\r\n\r\n          -  Major surgery of the spine was performed within 3 months before enrollment\r\n\r\n          -  Index vertebra(e) had previous spine surgery including vertebroplasty or kyphoplasty\r\n\r\n          -  Additional non-kyphoplasty/vertebroplasty surgical treatment is required for the index\r\n             vertebra\r\n      ","sponsor":"DFINE Inc.","sponsor_type":"Industry","conditions":"Metastatic Lesions in Vertebral Bodies","interventions":[{"intervention_type":"Device","name":"Device: STAR Tumor Ablation System and StabiliT Vertebral Augmentation System","description":"Radiofrequency targeted radiofrequency ablation (t-RFA) and targeted vertebral augmentation (RF-TVA)"}],"outcomes":[{"outcome_type":"primary","measure":"Pain relief","time_frame":"1 month","description":"Measured by the Numerical Rating Pain Scale (NRPS)"},{"outcome_type":"secondary","measure":"Change in function","time_frame":"up to 6 months","description":"Measured by Modified Oswestry Low Back Pain Disability Questionnaire (m-ODI)"},{"outcome_type":"secondary","measure":"Change in Quality of Life","time_frame":"up to 6 months","description":"Measured by European Organization for Research and Treatment of Cancer and Bone Metastasis Questionnaires (EORTC-C30 and EORTC-BM22)"},{"outcome_type":"secondary","measure":"Change in pain medications","time_frame":"up to 6 months"}]}
{"nct_id":"NCT02023632","start_date":"2014-01-31","phase":"N/A","enrollment":554,"brief_title":"GrOup-based Physical Activity for oLder Adults Trial","official_title":"A Self-categorization Theory Approach to Fostering Physical Activity Adherence Among Older Adults: A Randomized Controlled Feasibility Trial.","primary_completion_date":"2015-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-08-31","last_update":"2015-09-07","description":"Regular physical activity is associated with a diverse range of physical and mental health outcomes, with the effects being particularly pronounced among older adults. Despite these health benefits, involvement in physical activity has been found to decline over the course of adulthood with older adults in particular risk of inactivity. A growing body of evidence, however, suggests that group-based settings that are sensitive to both the age-composition and gender-composition of their constituent members may represent an opportune means of supporting the improved adoption and maintenance of older adults in physical activity programs. The overall purpose of this feasibility trial is to test the effectiveness of a group-based physical activity program for older adults that is sensitive to both age-congruent and gender-congruent contextual factors, in supporting their sustained involvement in physical activity.","other_id":"H13-01593","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Participants must be 65 years of age or older (both males and females), be able to\r\n             speak and read English, and not experience any contraindication which might prevent\r\n             that person from participating in moderate-intensity physical activity. Participants\r\n             will be required to complete PAR-Q+, and where necessary ePARmed-X.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  The only exclusionary criteria is that participants must be 65 years of age or older\r\n             (both males and females), be able to speak and read English, and not experience any\r\n             contraindication which might prevent that person from participating in\r\n             moderate-intensity physical activity.\r\n      ","sponsor":"University of British Columbia","sponsor_type":"Other","conditions":"Motor Activity","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Similar-Age-Same-Gender (SASG)","description":"The core feature of the program is that it is exclusively for those of a similar age and same gender. Such an environment was reported to provide opportunities for social connectedness, as well as personal comfort. Secondly, exercise class instructors are volunteers- both providing 'similar-models' to enhance efficacy as well as reduce costs associated with instructors. Consistent with social identity and self-categorization perspectives, the program also makes use of a series of strategies to foster intra-group attraction and group identity. For many of the participants a major draw of the program is that it provides opportunities for the older adults to connect with one another after the classes have ended."},{"intervention_type":"Behavioral","name":"Behavioral: Similar-Age-Mixed-Gender (SAMG)","description":"The SAMG physical activity condition will mirror the SASG group condition, but will be open to older adults from both genders. The same strategies to those used within the SASG condition will also be utilized (development of a unique program name, T-shirts, opportunities to socialize after the program), and will be offered three days per week (Mon, Wed, Fri, or Tues, Thurs, Sat). Older adults will also be recruited to be instructors for the group classes (= 65 years), with both males and females invited to occupy these instructional roles. (As with the SASG condition, training will take place between September and December 2013, through the respective YMCA centres. The YMCA will oversee the training of these volunteers through their Fitness Leader Training Program)."},{"intervention_type":"Behavioral","name":"Behavioral: Mixed-Age-Mixed-Gender (MASG)","description":"The third condition utilized within the RCT is designed to reflect 'standard' group based exercises that one sees in typical physical activity centres. Specifically, these classes are not restricted to participants on the basis of age or gender, and as such older adults will be participating in groups comprised of people younger than themselves as well as those of both gender."}],"outcomes":[{"outcome_type":"secondary","measure":"Change in Flourishing","time_frame":"Weeks 2, 7, 12, 14, 19, 24","description":"Diener et al's(2009) well-being measure of the relationship of flourishing and positive and negative feelings will be distributed post-class at each of the times listed above. This measure is on a 7-point Likert scale from strongly disagree to strongly agree with items such as \"I am engaged and interested in my daily activities\" and \"I am a good person and live a good life.\""},{"outcome_type":"primary","measure":"Program adherence and re-enrollment","time_frame":"Month 3 (May 2014;2015) and Month 6 (August 2014;2015)","description":"Physical activity centre records (i.e., the YMCA) will be utilized to provide an objective measure of class attendance through \"signing-in\". With regard to the secondary research question concerning the extent to which participants choose to re-enroll after the initial 3-month program has ended, program enrollment records will again be used."},{"outcome_type":"secondary","measure":"Change in Cohesion","time_frame":"Weeks 2, 7, 12, 14, 19, 24","description":"Class cohesion will be assessed using the Physical Activity Group Environment Questionnaire (PAGEQ. The PAGEQ is a 21-item self-report questionnaire designed to assess four dimensions of cohesion within exercise classes; namely, attraction to the group's task (ATG-T), and social (ATG-S) activities, as well as perceptions of group integration around the group's task (GI-T), and social (GI-S) activities. The PAGEQ was developed (by Dr. Estabrooks, Co-I) specifically with older adults in mind taking part in physical activity classes such as those involved in this trial, with scores derived from this instrument demonstrating good reliability (α ≥ .72), factorial validity, and predictive utility."},{"outcome_type":"secondary","measure":"Change in Affective and Instrumental Attitudes","time_frame":"Weeks 2, 7, 12, 14, 19, 24","description":"Affective attitudes towards physical activity will be assessed using the procedures outlined by Ajzen (2002). Specifically, a 7-point semantic differential scale will be used, with anchors including \"Enjoyable-Unenjoyable\", \"Pleasant-Unpleasant\", \"Interesting-Boring\". Previous research with older adults has found support for both the internal consistency and predictive utility of scores derived from this instrument."},{"outcome_type":"secondary","measure":"Physical Health Screening Measure","time_frame":"Prior to the start of the program (February 2014 and December 2014/January 2015)","description":"For pre-screening all individuals will complete the Physical Activity Readiness Questionnaire for everyone (PAR-Q+). If participants respond 'NO' to all of the (seven) questions within the PAR-Q+ they are cleared for participation in physical activity. If participants have a positive response to the PAR-Q+ (e.g., due to a current medical condition), participants automatically proceed to a second series of questions subsumed within the ePARmed-X. As a result of completing the ePARmed-X, they will either be cleared for participation in physical activity OR will be directed to their physician to obtain clearance before they can participate in physical activity. If older adults have a medical contraindication (flagged through the PAR-Q+ and ePARmedX) and have NOT been cleared to participate in physical activity by their physician they are then ineligible to participate in the study."},{"outcome_type":"secondary","measure":"Change in Self-efficacy","time_frame":"Weeks 2, 7, 12, 14, 19, 24","description":"During the program, in-class task self-efficacy will be measured through a validated and reliable measure (Poag-Ducharme & Brawley, 1993). Self-efficacy to overcome barriers to exercise (with an emphasis on self-regulation) will use Bray and colleagues (2001) validated and reliable measure; using 0-100% confidence. An example self-efficacy question is: how confident they may be in \"Completing the warm-up and stretching component of each class.\""},{"outcome_type":"secondary","measure":"Change in Stigma Consciousness","time_frame":"Weeks 2, 7, 12, 14, 19, 24","description":"To measure both gender and ethnicity stigma, we will use Pinel's (1999) measure for \"stigma consciousness.\" Each item is on a 6-point Likert scale. An example item is \"I never worry that I will be viewed as being stereotypically [fe]male.\""},{"outcome_type":"secondary","measure":"Change in Perceptual Similarity","time_frame":"Weeks 2, 14","description":"Using methods from Beauchamp et al (2012), participants will answer a series of questions regarding their perceived similarity via a 9-point Likert scale. Surface-level perceptions will be assessed through items related to age, physical condition, and physical appearance similarity, whereas deep-level perceptions will be assessed through items related to attitude, belief, and value similarity. Exemplar items from this assessment included, \"In my exercise class, I believe members are similar to me in terms of age.\""},{"outcome_type":"secondary","measure":"Change in commute time and commute mode","time_frame":"Weeks 2 and 14","description":"Two-item assessment of how participants commute to the YMCA location: 1. Typically, how long does it take for you to get to your physical activity class (i.e., commute time):________________ mins and 2) What mode of transport do you use to get to your physical activity class (car, bus, bike, train, walk, taxi):_____________________."},{"outcome_type":"secondary","measure":"Change in Group-Interaction Variables","time_frame":"Weeks 7 and 19","description":"To measure the group-interaction variables of interest (i.e., communication, cooperation, and competition) additional items are embedded within the PAGEQ. Communication will be measured through 6 items that can be further divided into task communication (e.g., 'members of our group talk about how often they should do physical activity') and social communication (e.g., 'people of this group talk about things that are happening in our lives'). Cooperation will be measured through 3 items (e.g., 'we all cooperate to help this group's program run smoothly') as will competition (e.g., 'There is friendly competition within the members to stay as healthy as possible'). Internal consistencies for the group-interaction variables were all previously acceptable: task communication (α = .94), social communication (α = .65), cooperation (α = .91), and friendly competition (α = .81) (Harden, Mama, Lee, Estabrooks, Under Review)."},{"outcome_type":"secondary","measure":"Change in Physical Activity Outside of the YMCA","time_frame":"Week 12, 24","description":"Physical activity outside of program will be measured by an adapted 3-step procedure outlined by Wilcox et al. (1999), specific for older adults. Participants will report on various activities that they engaged in over the last two weeks as well as how many times and the duration associated with each. Participants will also answer whether they experienced (a) no, (b) small, (c) moderate, or (d) large increases in heart and breathing rates while participating."},{"outcome_type":"secondary","measure":"Change in Functional Fitness Appraisal","time_frame":"Prior to the start of the program (February 2014, January 2015) and after the end of the program (August 2014, 2015)","description":"Functional fitness testing will be conducted based on a previously developed and validated functional fitness test for community-residing older adults (Rikli, R. E., & Jones, C. J. 1999). The assessment will include measures of upper and lower body strength and flexibility, aerobic endurance, dynamic balance, and Body Mass Index. These tests will be done at the participant's local YMCA by trained research assistants."},{"outcome_type":"other","measure":"Process Evaluation","time_frame":"After the end of the program (August 2014, 2015)","description":"The process evaluation procedures to be used in this study first involves identifying fidelity to the five key components of the intervention. Second, semi-structured interviews will be used that allow us to examine each of the subcomponents described in the first step. Interviews will be conducted with participants by trained research assistants, and although qualitative data analysis will be overseen by the principal investigator, the coding will be performed by research assistants (i.e., unconnected with the intervention activities)."}]}
{"nct_id":"NCT02288065","start_date":"2014-01-31","enrollment":155,"brief_title":"Predictive Factors and Outcome in Medical Thoracoscopy","official_title":"Predictive Factors and Outcome in Medical Thoracoscopy","primary_completion_date":"2016-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2016-12-31","last_update":"2016-12-30","description":"Retrospective survey for factors predicting the outcome of medical thoracoscopy","other_id":"S561430","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"pulmonary or extrathoracic malignancy","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  progressive malignancy\r\n\r\n          -  pleuritis\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  respiratory failure\r\n\r\n          -  unable to consent\r\n      ","sponsor":"KU Leuven","sponsor_type":"Other","conditions":"Pleuritis","interventions":[{"intervention_type":"Drug","name":"Drug: sterile talc pleurodesis","description":"medical thoracoscopy and talc pleurodesis. No specific device is studied."}],"outcomes":[{"outcome_type":"primary","measure":"Chest X-ray","time_frame":"3 months","description":"radiological resolution of pleuritis; 3 level severity grading (A, B, C, with C as worst grade)"},{"outcome_type":"secondary","measure":"time interval","time_frame":"12 months","description":"survival in months"}]}
{"nct_id":"NCT01899352","start_date":"2014-01-31","phase":"N/A","enrollment":1000,"brief_title":"Procedures, Complications and Follow-up of Tracheostomy in Intensive Care Units.","official_title":"Procedures, Complications and Follow-up of Tracheostomy in Intensive Care Units - a Prospective Study by Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care (SIAARTI)","primary_completion_date":"2016-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2017-01-31","last_update":"2013-07-15","description":"Tracheostomy is worldwide used for critically ill patients. The aim of our study is to assess the mortality, quality of life, laryngeal function, procedures, early and late complications of tracheostomy performed for critically ill patients admitted in intensive care units.","other_id":"PCF-TracheoTrial","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  age > 18 years\r\n\r\n          -  indications for tracheostomy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Infection/inflammation of neck tissue\r\n\r\n          -  Previous neck surgery causing abnormal anatomy of the site\r\n\r\n          -  Recent surgery of cervical spine\r\n      ","sponsor":"University of Genova","sponsor_type":"Other","conditions":"Respiratory Failure|Neurological Disease|Heart Failure|Airway Management","interventions":[{"intervention_type":"Procedure","name":"Procedure: Tracheostomy","description":"Percutaneous and surgical tracheostomies will be performed with the procedure currently available in clinical practice."}],"outcomes":[{"outcome_type":"primary","measure":"Mortality at ICU discharge","time_frame":"within 2 days after discharge"},{"outcome_type":"secondary","measure":"Quality of Life","time_frame":"within 2 days after discharge, at 3, 6 and 12 months after tracheostomy","description":"Quality of life will be evaluated at 3, 6 and 12 months after the discharge from the intensive care unit."},{"outcome_type":"secondary","measure":"Laryngeal organ function","time_frame":"within 2 days after discharge, at 3, 6 and 12 months after tracheostomy","description":"Laryngeal organ function will be evaluated at 3, 6 and 12 months after the discharge from intensive care unit."},{"outcome_type":"secondary","measure":"Late complications","time_frame":"from day 2 until the discharge"},{"outcome_type":"secondary","measure":"Procedural findings of percutaneous tracheostomy","time_frame":"at the beginning and at the end of tracheostomy procedures"},{"outcome_type":"secondary","measure":"Early complication","time_frame":"in the first 24 hours from the end of the procedure"}]}
{"nct_id":"NCT03476967","start_date":"2014-01-31","enrollment":30,"brief_title":"Effect of Laser Treatment for Diabetic Retinopathy on the Optic Disc Topography","official_title":"Effect of Panretinal Photocoagulation on Confocal Laser Scanning Ophthalmoscopy and Stereo Photographic Parameters of the Optic Disc Topography in Diabetic Retinopathy Patients","primary_completion_date":"2017-01-31","study_type":"Observational [Patient Registry]","rec_status":"Completed","completion_date":"2017-01-31","last_update":"2018-03-26","description":"This study analyzed diabetic patients without evidence of glaucoma who underwent panretinal photocoagulation to determine the effect on optic disc topographic parameters in non-glaucomatous patients with proliferative diabetic retinopathy (PDR).","other_id":"USaoPauloGH 12423","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","population":"Patients followed in the ophthalmology department of Hospital das Clnicas da FMUSP who\r\n        have type I or II diabetes mellitus and present severe or very severe non proliferative\r\n        diabetic retinopathy or proliferative diabetic retinopathy in cases where retinal\r\n        panphotocoagulation is indicated.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  diagnosis of PDR (due to type 1 or 2 diabetes mellitus)\r\n\r\n          -  intraocular pressure < 18 mmHg\r\n\r\n          -  nonglaucomatous optic disc characteristics at fundus examination\r\n\r\n          -  vertical cup-to-disc (C/D) ratio <0.7\r\n\r\n          -  absence of media opacities\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  previous diagnosis of glaucoma\r\n\r\n          -  family history of glaucoma\r\n\r\n          -  neuroophthalmic disease\r\n\r\n          -  uveitis\r\n\r\n          -  retinal artery or vein occlusion\r\n\r\n          -  optic disc neovascularization\r\n\r\n          -  diabetic macular edema (DME)\r\n\r\n          -  corneal opacity\r\n\r\n          -  previous laser photocoagulation treatment\r\n      ","sponsor":"University of Sao Paulo General Hospital","sponsor_type":"Other","conditions":"Diabetic Retinopathy","interventions":[{"intervention_type":"Procedure","name":"Procedure: Panretinal photocoagulation","description":"In cases of proliferative diabetic retinopathy (PDR), panretinal photocoagulation (PRP) is the first-line treatment. Although PRP reduces the risk of severe vision loss, it has been shown that laser energy can cause destruction to all layers of retina including the ganglion cells and the retinal nerve fiber layer (RNFL), and therefore generate visual field defects similar to that observed in glaucomatous damage. In such cases, visual field testing can be less helpful to evaluate glaucomatous damage in PDR patients treated with PRP."}],"outcomes":[{"outcome_type":"primary","measure":"Cup area","time_frame":"12 months","description":"Change in cup area (mm2) measured by Heidelberg retinal tomograph (HRT) before and one year after PRP"}]}
{"nct_id":"NCT02139683","start_date":"2014-01-31","phase":"N/A","enrollment":50,"brief_title":"Feasibility Study Assessing the Treatment of Fibroadenomata With a Circumferential Sonication Treatment With HIFU","official_title":"High Intensity Focused Ultrasound for the Treatment of Fibroadenomata (HIFU-F)","primary_completion_date":"2016-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-01-31","last_update":"2018-05-30","description":"The purpose of this study is to assess the treatment of fibroadenomata with a circumferential sonification treatment with HIFU..","other_id":"HIFU-F","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients >18 years of age\r\n\r\n          -  Fibroadenomata diagnosed according to local hospital protocol; ultrasound alone on\r\n             patients <25 and ultrasound plus core-biopsy in patients >25 (Graded B2 or less)\r\n\r\n          -  Visible on ultrasound (Graded U2/U3)\r\n\r\n          -  Definitive diagnosis of fibroadenomata confirmed by the Breast multi-disciplinary team\r\n             meeting (MDT).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Lesion with atypia or suspicion of phyllodes (Graded B3 or greater)\r\n\r\n          -  Pregnant or lactating women\r\n\r\n          -  History of laser or radiation therapy to the targeted breast\r\n      ","sponsor":"Theraclion","sponsor_type":"Industry","conditions":"Breast Fibroadenoma","interventions":[{"intervention_type":"Device","name":"Device: HIFU treatment","description":"HIFU treatment in patients with fibroadenoma"}],"outcomes":[{"outcome_type":"primary","measure":"Changes in size of fibroadenomata as recorded on ultrasound imaging","time_frame":"Month 1, Month 3, Month 12"},{"outcome_type":"secondary","measure":"Adverse Events","time_frame":"Month 1, Month 3, Month 12"},{"outcome_type":"secondary","measure":"Patient recorded outcomes measures","time_frame":"Month 1, Month 3, Month 12","description":"Patient questionnaires and VAS scales"},{"outcome_type":"secondary","measure":"Mean treatment time","time_frame":"Treatment visit date"},{"outcome_type":"secondary","measure":"Cost-effectiveness","time_frame":"12 months"}]}
{"nct_id":"NCT03189992","start_date":"2014-01-31","phase":"Phase 1","enrollment":320,"brief_title":"Study of TCM Syndrome of Hepatocellular Carcinoma and Colorectal Cancer Based on System Science","official_title":"Study of \"Same TCM Syndrome for Different Diseases\" and \"Same Treatment for Different Diseases\" of Primary Hepatocellular Carcinoma and Colorectal Cancer Under the Perspective of System Science","primary_completion_date":"2017-08-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2018-12-31","last_update":"2017-06-16","description":"Traditional Chinese medicine (TCM) syndrome is a core foundation of disease knowledge, clinical diagnosis and treatment and curative effect evaluation in TCM. \"Same TCM Syndrome for Different Diseases\" and \"Same Treatment for Different Diseases\" is one of the characteristics of TCM syndrome differentiation and treatment. This study is the \"TCM disease syndrome combination\" research baced on principles and methods of system biology, which is through acquisition of primary hepatocellular carcinoma (HCC) and colorectal cancer patients with TCM syndrome information, detection of clinical indicators and genomic, proteomic, and metabolites changes, analyzing the correlation between TCM syndromes and biological information, and revealing its biological material characteristics and the molecular mechanisms of \"Same TCM Syndrome for Different Diseases\";Developing and implementing the program of TCM syndrome differentiation and treatment for HCC and colorectal cancer to evaluate the efficacy of TCM syndrome based-treatment of HCC and colorectal cancer with TCM syndrom scores, clinical and systems biological indicators, quality of life and survival rate, and to revealing the mechanism of the \"Same Treatment for Different Diseases\".","other_id":"ShanghaiUTCM","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Clinical diagnosis of primary liver cancer (HCC) and colorectal cancer after surgery.\r\n\r\n          2. Liver cancer and colorectal cancer liver and kidney yin deficiency and spleen qi\r\n             deficiency syndrome diagnosis standard : Yin deficiency of liver and kidney and spleen\r\n             qi deficiency syndrome see hypochondriac pain, waist and knee Limp, fever, night\r\n             sweats, dry mouth and throat, fatigue, anorexia, abdominal distension after eating\r\n             more, red or pale tongue, less moss or Light peel, pulse fine.\r\n\r\n        Exclusion Criteria:\r\n\r\n        (1) there is a serious heart, kidney, and other diseases of the hematopoietic system effect\r\n        of drug evaluation factors; (2)Mental disorders (3)Digestive tract obstruction; (4) poor\r\n        compliance.\r\n      ","sponsor":"Shanghai University of Traditional Chinese Medicine","sponsor_type":"Other","conditions":"Malignant Tumor of Small Intestine Metastatic to Liver","interventions":[{"intervention_type":"Drug","name":"Drug: Bushen-Jianpi Dedoction","description":"A traditional chinese medicine prescription"},{"intervention_type":"Drug","name":"Drug: cinobufotalin injection","description":"an effective Chinese preparation to treat malignant tumor."}],"outcomes":[{"outcome_type":"primary","measure":"Complete patient recruitment","time_frame":"24 months","description":"Complete transcriptome microarray detection"}]}
{"nct_id":"NCT01902901","start_date":"2014-01-31","phase":"N/A","enrollment":384,"brief_title":"Clinical Implementation of Carrier Status Using Next Generation Sequencing","official_title":"Clinical Implementation of Carrier Status Using Next Generation Sequencing","primary_completion_date":"2017-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-05-31","last_update":"2019-04-17","description":"This study is conducting a randomized controlled trial (RCT) with up to 400 subjects (women & partners) seeking pre-conception carrier testing to assess the impact of the program using Whole Genome Sequencing (WGS). 1. The investigators hypothesize that whole genome sequencing will increase the detection of carrier status for Mendelian recessive and x-linked conditions. 2. The investigators hypothesize that parents will act on the knowledge of their carrier status by making different reproductive choices than parents who do not receive this information. 3. The investigators hypothesize that the psychosocial risks are increased among parents who receive expanded carrier screening using Next Generation Sequencing (NGS) compared with usual care.","other_id":"1UM1HG007292-01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Screening","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":21,"maximum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Seeking pre-conception carrier status testing or had carrier testing during pregnancy\r\n\r\n          -  Women with a male partner that can be contacted\r\n\r\n          -  Kaiser Permanente Northwest members\r\n\r\n          -  English speaking\r\n\r\n          -  Not currently pregnant\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Currently pregnant\r\n\r\n          -  No known or accessible male partner\r\n\r\n          -  Not an English speaker\r\n\r\n          -  Not a Kaiser Permanente member\r\n      ","sponsor":"Kaiser Permanente","sponsor_type":"Other","conditions":"Genetic Disorders","interventions":[{"intervention_type":"Genetic","name":"Genetic: Carrier status testing","description":"Carrier status testing"},{"intervention_type":"Genetic","name":"Genetic: Whole Genome Sequencing","description":"Participants will receive Whole Genome Sequencing"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Patients That Receive Carrier Testing and Have Results to Return","time_frame":"Assessed annually for 4 years, data at the end of the study reported.","description":"The investigators will record the number of patients that have both single carrier status testing (usual care) and WGS testing and track how many patients have results to return."},{"outcome_type":"secondary","measure":"Patient Satisfaction","time_frame":"Assessed annually for 4 years, data at the end of Year 3 reported.","description":"Through surveys, interviews, and observations with patients, the investigators will assess their satisfaction with the testing and return of results process."},{"outcome_type":"other","measure":"Healthcare Utilization","time_frame":"The end of Year 4","description":"The investigators will evaluate if expanded carrier testing using WGS causes an increase in subsequent health care utilization compared to usual care (typically just cystic fibrosis carrier testing)."}]}
{"nct_id":"NCT01977534","start_date":"2014-01-31","enrollment":1005,"brief_title":"To Study the Safety and Clinical Outcomes of the Absorb Bioresorbable Vascular Scaffold (BVS) System in Patients With de Novo Lesions in Previously Untreated Vessels","official_title":"A Post-market Registry of Patients With de Novo Lesions in Previously Untreated Vessels Treated With Absorb BVS","primary_completion_date":"2018-10-31","study_type":"Observational [Patient Registry]","rec_status":"Completed","completion_date":"2018-10-31","last_update":"2018-12-17","description":"The purpose of this study is to determine the safety and clinical outcomes of the Absorb BVS for daily use in patients with de novo lesions in previously untreated vessels.","other_id":"13-304","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients will be selected from the general interventional cardiology population","criteria":"\n        Inclusion Criteria:\r\n\r\n        The inclusion criteria must follow the most recent IFU which may include but are not\r\n        limited to the following:\r\n\r\n          -  Patient must be at least 18 years of age at the time of signing the Informed Consent\r\n             Form\r\n\r\n          -  Patient is to be treated for de novo lesions located in previously untreated vessels.\r\n\r\n          -  Patient must agree to undergo all required follow-up visits and data collection.\r\n\r\n        Exclusion Criteria:\r\n\r\n        The exclusion criteria must follow the most recent IFU which may include but are not\r\n        limited to the following:\r\n\r\n          -  Inability to obtain a signed informed consent from potential patient.\r\n\r\n          -  Patient belongs to a vulnerable population (per investigator's judgment, this also\r\n             includes people with a direct link (hierarchical or financial benefit) to the registry\r\n             Doctor or the registry Sponsor).\r\n      ","sponsor":"Abbott Medical Devices","sponsor_type":"Industry","conditions":"Coronary Disease|Coronary Artery Disease|Coronary Restenosis","interventions":[{"intervention_type":"Device","name":"Device: Absorb BVS","description":"The Absorb BVS System is a bioresorbable poly(L-lactide) (PLLA) scaffold with a drug and bioresorbable polymer coating [formulation of everolimus in a bioresorbable poly(D,L-lactide) (PDLLA) coating]."}],"outcomes":[{"outcome_type":"primary","measure":"Scaffold/Stent Thrombosis","time_frame":"1 year","description":"acute, sub-acute, late and very late"},{"outcome_type":"primary","measure":"Scaffold/Stent Thrombosis","time_frame":"1 year","description":"Definite, Probable"},{"outcome_type":"primary","measure":"Scaffold/Stent Thrombosis","time_frame":"3 year","description":"acute, sub-acute, late and very late"},{"outcome_type":"primary","measure":"Scaffold/Stent Thrombosis","time_frame":"3 year","description":"Definite, Probable"},{"outcome_type":"primary","measure":"Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF))","time_frame":"3 year"},{"outcome_type":"primary","measure":"Acute Success: Device success (lesion based analysis)","time_frame":"From the start of index procedure to end of index procedure","description":"Achievement of a final in-scaffold residual diameter stenosis of < 50% assessed by online quantitative angiography or visual estimation, using Absorb BVS and without a device deficiency. A device is considered to have failed if it did not meet the requirements of the definition for clinical device success."},{"outcome_type":"primary","measure":"Acute Success: Procedural success (patient based analysis)","time_frame":"From the start of index procedure to end of index procedure","description":"Achievement of a final in-scaffold diameter stenosis of < 50% by online QCA or visual estimation using Absorb BVS, with or without any adjunctive devices, and without the occurrence of cardiac death, target vessel MI (Q-wave and non Q-wave MI), or repeat revascularization of the target lesion within 3 days of the index procedure."},{"outcome_type":"primary","measure":"Death (Cardiovascular, Non-Cardiovascular)","time_frame":"1 year"},{"outcome_type":"primary","measure":"Death (Cardiovascular, Non-Cardiovascular)","time_frame":"3 year"},{"outcome_type":"primary","measure":"Myocardial Infarction (MI)","time_frame":"1 year","description":"Attributable to Q-wave MI (QMI), non-Q wave MI (NQMI), target vessel (TV), non-target vessel (NTV)"},{"outcome_type":"primary","measure":"MI","time_frame":"3 year","description":"Attributable to Q-wave MI (QMI), non-Q wave MI (NQMI), target vessel (TV), non-target vessel (NTV)"},{"outcome_type":"primary","measure":"Target Lesion Revascularization (TLR)","time_frame":"1 year","description":"all TLR"},{"outcome_type":"primary","measure":"TLR","time_frame":"3 year","description":"all TLR"},{"outcome_type":"primary","measure":"TLR","time_frame":"1 year","description":"clinically indicated (ID-TLR)"},{"outcome_type":"primary","measure":"TLR","time_frame":"3 year","description":"ID-TLR"},{"outcome_type":"primary","measure":"Target Vessel Revascularization (TVR)","time_frame":"1 year","description":"all TVR"},{"outcome_type":"primary","measure":"TVR","time_frame":"3 year","description":"all TVR"},{"outcome_type":"primary","measure":"TVR","time_frame":"1 year","description":"clinically indicated (ID-TVR)"},{"outcome_type":"primary","measure":"TVR","time_frame":"3 year","description":"ID-TVR"},{"outcome_type":"primary","measure":"Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) (Device-oriented endpoint)","time_frame":"1 year"},{"outcome_type":"primary","measure":"Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) (Device-oriented endpoint)","time_frame":"3 year"},{"outcome_type":"primary","measure":"Cardiac Death/All MI/ID-TLR (MACE)","time_frame":"1 year"},{"outcome_type":"primary","measure":"Cardiac Death/All MI/ID-TLR (MACE)","time_frame":"3 year"},{"outcome_type":"primary","measure":"Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF))","time_frame":"1 year"},{"outcome_type":"other","measure":"Acute Procedural Analyses (all patients)","time_frame":"During the implantation procedure","description":"Access site (femoral, brachial, radial)\r\nLesion preparation (Lesion 1, 2, 3, etc.)\r\nBalloon pre-dilatation (yes - Max balloon size/Max balloon pressure, Cutting balloon yes/no, Other yes/no)\r\nTechniques used to adequately prepare the lesion (de-calcification techniques (Rotablator yes/no, Other yes/no))\r\nTreatment parameters\r\nCASS numbers\r\nNo. of scaffolds per analyzable lesion (Lesion 1, 2, 3, etc.)\r\nScaffold length (Lesion 1, Lesion 2, Lesion 3, etc.)\r\nLesion length (Lesion 1, Lesion 2, Lesion 3, etc.)\r\nBailout / bailout device (if bailout required)\r\nPost-treatment of lesion?\r\nBalloon post-dilatation (no, yes - Max balloon diameter/Max balloon pressures/balloon length)\r\nJailed side-branch (no, yes). If yes, treatment of jailed sidebranch? (no, yes)"}]}
{"nct_id":"NCT02405117","start_date":"2014-01-10","phase":"N/A","enrollment":14,"brief_title":"A Mobile Behavioral Monitoring Intervention for Bipolar Disorder","official_title":"A Mobile Behavioral Monitoring Intervention for Bipolar Disorder","primary_completion_date":"2017-04-10","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-04-10","last_update":"2017-04-19","description":"This study will develop and pilot a smartphone intervention, LiveWell, to enhance patient self-management of bipolar disorder and facilitate more efficient, timely care delivery by mental health providers. The intervention uses a mobile application to collect daily self-report and continuous behavioral data and adapts intervention content to create a highly tailored and user-responsive treatment system. Patient data collected by the phone will also be provided to clinicians to allow for better evaluation and targeting of treatment. The goal is to reduce symptoms and prevent relapse in patients with bipolar disorder.","other_id":"1R34MH100460","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  DSM-IV diagnosis of Bipolar Disorder Type I.\r\n\r\n          -  Minimum of 2 acute episodes in last 2 years.\r\n\r\n          -  Receiving psychiatric care from a mental health provider willing to receive\r\n             notifications and information regarding subject symptom status via the LiveWell\r\n             system.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Not involved in current psychiatric care.\r\n\r\n          -  Current substance use disorders or other psychiatric diagnosis or symptoms (e.g.\r\n             dissociate disorder, psychotic symptoms) for which participation in this study is\r\n             either inappropriate or dangerous.\r\n\r\n          -  Pregnancy or plans to become pregnant.\r\n\r\n          -  Visual impairments limiting mobile phone use.\r\n\r\n          -  An inability to speak and read English.\r\n      ","sponsor":"Northwestern University","sponsor_type":"Other","conditions":"Bipolar Disorder","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: LiveWell System","description":"For 16 weeks, participants will be asked to carry a mobile phone and wear a wrist-worn device for measuring activity. Participants in this arm will receive the psychosocial intervention via a smartphone and context-dependent feedback based on self-report and behavioral data. Providers whose patients are randomized to this arm will also be asked to enroll in order to receive information and notifications about patient status for the duration of the study"}],"outcomes":[{"outcome_type":"primary","measure":"Percent Time Symptomatic","time_frame":"Participants will be followed for the duration of the 16 week trial.","description":"Percent time symptomatic will be assessed using ratings that measure the presence and severity of manic and depressive symptoms."}]}
{"nct_id":"NCT03790579","start_date":"2014-01-05","enrollment":80,"brief_title":"Dietary Acid Load During Pregnancy and Gestational Diabetes Mellitus","official_title":"Is There Any Effect of Maternal Dietary Acid Load During Pregnancy on Arising Gestational Diabetes Mellitus?","primary_completion_date":"2014-09-05","study_type":"Observational","rec_status":"Completed","completion_date":"2014-10-05","last_update":"2019-01-02","description":"Dietary habits resembling Western style, rich in animal protein and poor in fruit and vegetables, increase the body acid load, a predictor of type 2 diabetes risk. Recently, the studies related to relationships between dietary acid load and insulin resistance has become a growing interest but there are only a few study conducted with gestational diabetes mellitus (GDM). Therefore, the aim of this study was to evaluate the potential relationship between dietary acid load in second trimester, blood lipid profiles and GDM.","other_id":"Hacettepe Nutrition","observational_model":"Case-Control","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"Female","minimum_age":21,"maximum_age":41,"population":"In this observational cross-sectional study, 40 women with GDM and 40 healthy pregnant\r\n        between 21-41 years in age, in their 24-28th gestational week applied to Gulhane Education\r\n        and Research Hospital were recruited. This study must recruit 40 women for each group to\r\n        have 80% study power with 5% type I error level to detect a clinically significant\r\n        difference.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Singleton pregnancy,\r\n\r\n          -  Aged in 20-40 years,\r\n\r\n          -  Gestational age 24-28 weeks,\r\n\r\n          -  Non-history of acute or chronic diseases.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of GDM,\r\n\r\n          -  Type 1 and 2 diabetes mellitus,\r\n\r\n          -  Preeclampsia,\r\n\r\n          -  Polycystic ovary syndrome,\r\n\r\n          -  Thyroid disease\r\n\r\n          -  Parathyroid disease,\r\n\r\n          -  Metabolic bone disease,\r\n\r\n          -  Kidney disease,\r\n\r\n          -  Abnormal liver function,\r\n\r\n          -  Multiple pregnancy\r\n\r\n          -  Extreme values of energy intake in their dietary records (<1500 and >4000 kkal).\r\n      ","sponsor":"Hacettepe University","sponsor_type":"Other","conditions":"Diabetes, Gestational|Dietary Habits","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Dietary acid load","time_frame":"24-28. weeks of pregnancy","description":"According to the data obtained from software analysis, animal protein (g/day) to potassium (g/day) ratio (AP/K), potential renal acid load (PRAL; mEq/day) score and net endogenous acid production (NEAP; mEq/day) were calculated from established algorithms to estimate dietary acid load."}]}
{"nct_id":"NCT03271359","start_date":"2014-01-05","phase":"N/A","enrollment":40,"brief_title":"EMDR vs. PC For Motor Vehicle Accident Trauma","official_title":"EMDR vs. PC For Motor Vehicle Accident Trauma","primary_completion_date":"2017-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2017-12-31","last_update":"2017-09-07","description":"This is a randomized clinical trial comparing eye movement desensitization and reprocessing (EMDR) to progressive counting (PC) for volunteers from the community who are distressed by the memory of a motor vehicle accident. Participants will be assigned to the geographically nearest therapist, and then randomized to treatment condition.","other_id":"2015-GRE-3","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  adult reporting distress related to motor vehicle accident-related trauma\r\n\r\n          -  English-speaking\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  already in therapy in which the memory of interest is being actively addressed with a\r\n             structured/focused trauma resolution method\r\n\r\n          -  any obvious/urgent need for more comprehensive psychotherapy (based on initial\r\n             screening interview)\r\n\r\n          -  any indication of instability during interactions prior to the therapy session\r\n\r\n          -  an average score on the Dissociative Experiences Scale of 30 or greater, if (as per\r\n             follow-up questions) indicating a likely dissociative disorder\r\n      ","sponsor":"Trauma Institute & Child Trauma Institute","sponsor_type":"Other","conditions":"Trauma, Psychological|Motor Vehicle Accident","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: EMDR","description":"Initial EMDR session of up to three hours; about one week later, follow-up session of up to one hour"},{"intervention_type":"Behavioral","name":"Behavioral: PC","description":"Initial PC session of up to three hours; about one week later, follow-up session of up to one hour"}],"outcomes":[{"outcome_type":"primary","measure":"Change in SUDS following treatment","time_frame":"Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment","description":"Subjective Units of Distress Scale"},{"outcome_type":"primary","measure":"Change in PRS following treatment","time_frame":"Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment","description":"Problem Rating Scale"},{"outcome_type":"primary","measure":"Change in PDS following treatment","time_frame":"Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment","description":"PTSD Diagnostic Scale"}]}
{"nct_id":"NCT03904056","start_date":"2014-01-01","phase":"N/A","enrollment":23,"brief_title":"ETDRS PRP With IVR Versus Retinal Photocoagulation Targeted to Ischemic Retina With IVR for the Treatment of PDR","official_title":"ETDRS Panretinal Photocoagulation (PRP) Combined With Intravitreal Ranibizumab (IVR) Versus Retinal Photocoagulation Targeted to Ischemic Retina Combined With IVR for the Treatment of Proliferative Diabetic Retinopathy","primary_completion_date":"2017-07-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-07-01","last_update":"2019-04-04","description":"Purpose: To compare panretinal photocoagulation (PRP) as described in ETDRS Study combined with intravitreal injection of ranibizumab (IVR) (ETDRS-PRP group) and retinal photocoagulation targeted to ischemic retina combined with IVR (ISQ-RP group) in patients with proliferative diabetic retinopathy (PDR). Design: Randomized prospective clinical trial. Methods: Patients with PDR were assigned to receive either PRP plus IVR (20 eyes) or retinal photocoagulation targeted to ischemic areas plus IVR (20 eyes). ETDRS best-corrected visual acuity (BCVA), central subfield macular thickness (CSFT) measured by optical coherence tomography (OCT) were performed at baseline and every 4 weeks through week 48. Area of fluorescein leakage from active new vessels (FLA) was measured every 12 weeks. Full-field electroretinography (ERG) was recorded at baseline and after 3 months.","other_id":"4160/2014","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  adult patients with treatment-naive PDR and a best-corrected visual acuity (BCVA)\r\n             better than 20/800\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Presence of advanced PDR, i.e., vitreous hemorrhage that would prevent documentation\r\n             of the fundoscopic examination or administration of PRP, or presence of traction\r\n             retinal detachment;\r\n\r\n          -  presence of ring-shaped retinal neovascularization extending along both temporal\r\n             arcades and the optic disc;\r\n\r\n          -  an abnormality of the vitreoretinal interface in the macular region that would lead\r\n             the investigator to consider the necessity of pars plana vitrectomy;\r\n\r\n          -  intravitreal injection of corticosteroids or other antiangiogenic drugs during the\r\n             prior 6 months;\r\n\r\n          -  inability of patient to fixate and perform reliable automated static perimetry;\r\n\r\n          -  cataract surgery during the prior 3 months;\r\n\r\n          -  history of pars plana vitrectomy or scleral buckle;\r\n\r\n          -  acute ocular infection;\r\n\r\n          -  allergy to fluorescein;\r\n\r\n          -  medical or psychological conditions that would prevent the patient from giving written\r\n             informed consent or completing the study;\r\n\r\n          -  significant uncontrolled disease that, in the opinion of the investigator, would\r\n             prevent the patient from completing the study;\r\n\r\n          -  participation in another clinical study during the previous 30 days.\r\n      ","sponsor":"So Paulo State University","sponsor_type":"Other","conditions":"Diabetic Retinopathy","interventions":[{"intervention_type":"Procedure","name":"Procedure: ISQ-RP","description":"Patients were treated with single-spot targeted retinal photocoagulation directed toward areas of retinal nonperfusion detected by fluorescein angiography. In this group, laser treatment was performed in two sessions (week 0 and 2), with a shot duration of 100 ms, but spots were placed 1/2 burn apart and power modulated in order to generate moderately white spots on the retina.\r\nRetinal photocoagulation was performed with single-spot full-scatter PRP using Purepoint green diode laser (Alcon, Fortworth, Texas) with an Ocular Mainster PRP 165 lens with a dynamic field of view of 180 degrees, and a 200 micron spot size (which produces a 392 micron spot size on the retina). Intravitreal injection of 0.5 mg (0.05 ml) ranibizumab (Lucentis) (IVR) were performed 180 minutes after the first laser session (week 0) by a single retina specialist."},{"intervention_type":"Procedure","name":"Procedure: ETDRS-PRP group","description":"Panretinal photocoagulation (PRP) as described in ETDRS Study combined with intravitreal injection of ranibizumab"}],"outcomes":[{"outcome_type":"primary","measure":"Fluorescein leakage area of active new vessels (FLA)","time_frame":"48 weeks","description":"Compare the Area of fluorescein leakage from active new vessels in both groups in mm2 measured by wide field fluorescein angiography (Optomap 200TX; Optos PLC., Dunfermline, Scotland, United Kingdom)"},{"outcome_type":"secondary","measure":"Best-corrected visual acuity (BCVA)","time_frame":"48 weeks","description":"Compare the Best-corrected visual acuity (BCVA) in both groups according to standardized ETDRS refraction protocols using modified ETDRS cards"},{"outcome_type":"secondary","measure":"Central subfield thickness (CSFT)","time_frame":"48 weeks","description":"Compare the Central subfield thickness (CSFT) between both groups using spectral domain optical coherence tomography (SD-OCT) (HRA-OCT, Heidelberg, Germany)"},{"outcome_type":"secondary","measure":"Number of Ranibizumab Intravitreal Injections","time_frame":"48 weeks","description":"to compare the number of Ranibizumab Intravitreal Injections in both groups"},{"outcome_type":"secondary","measure":"Electroretinography","time_frame":"48 weeks","description":"To compare Electroretinography response in both groups using Diagnosys LLD - Espion E2 Electroretinography System"}]}
{"nct_id":"NCT03415477","start_date":"2014-01-01","phase":"Phase 1/Phase 2","enrollment":6,"brief_title":"Denosumab: A Potential Treatment Option for Aneurysmal Bone Cysts","official_title":"Denosumab: A Potential Treatment Option for Aneurysmal Bone Cysts","primary_completion_date":"2016-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-12-31","last_update":"2018-01-30","description":"The efficacy of traditional therapeutic approaches for aneurysmal bone cysts (ABC), such as surgery, embolization, sclerotherapy and radiotherapy, are often compromised for lesions in axial skeletons and adolescents complicated with pathological fracture. Therefore, denosumab, a new drug that has been successfully used in giant cell tumor of bone but has seldom used in ABC, was used to treat ABC in this trial.","other_id":"Denosumab-ABC","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Patients with recurrent and/or refractory aneurysmal bone cysts treated with denosumab perioperatively.","sampling_method":"","gender":"All","minimum_age":12,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. pathologically diagnosed with primary aneurysmal bone cyst\r\n\r\n          2. lesions in axial skeletons (i.e. spine, pelvis) which are difficult to reach a\r\n             satisfactory surgical margin, and surgery can lead to very high incidence of\r\n             complications.\r\n\r\n          3. pathological fracture\r\n\r\n          4. recurrence cases\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. metastases or multi-focal lesions\r\n\r\n          2. malignancy\r\n      ","sponsor":"Peking University People's Hospital","sponsor_type":"Other","conditions":"Bone Cyst Aneurysmal|Pathological Fracture|Recurrent Disease|Refractory Tumor","interventions":[{"intervention_type":"Drug","name":"Drug: Denosumab (Xgeva)","description":"Denosumab (Xgeva) 120 mg was given subcutaneously (abdomen wall or upper arms) every 4 weeks (Q4W), with a loading dose on both Day 8 and Day15 of the first cycle perioperatively."}],"outcomes":[{"outcome_type":"primary","measure":"Objective Response Rate (ORR)","time_frame":"at least 1-year","description":"the number of participats (complete response+ partial response according to RECIST 1.1)/ total participants number."},{"outcome_type":"primary","measure":"local control rate","time_frame":"at least 1-year","description":"CT or MR proof that the tumor relapse in the primary site by at least two radiologist."},{"outcome_type":"secondary","measure":"Number of participants with abnormal laboratory values and/or adverse events that are related to the use of Denosumab（Xgeva）","time_frame":"at least 1-year","description":"include patient-reported adverse reactions, X-ray image of jawbone, serum calcium, alkaline phosphatase, renal and hepatic function, hemoglobin, white blood cell, and platelet count were collected in follow-up every 3-month."}]}
{"nct_id":"NCT02011763","start_date":"2013-12-31","phase":"Phase 4","enrollment":355,"brief_title":"Safety of Two Doses of Avaxim 80U Pediatric (Inactivated Hepatitis A Vaccine) in Toddlers, Children and Adolescents","official_title":"Safety of Two Doses of Avaxim 80U Pediatric (Inactivated Hepatitis A Vaccine) Administered 6 Months Apart in Healthy Toddlers, Children and Adolescents Aged 12 Months to 15 Years in China","primary_completion_date":"2014-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-08-31","last_update":"2015-10-01","description":"The aim of this study is to describe the safety profile of Avaxim 80U Pediatric, in order to confirm the good safety profile of the vaccine. Primary objective: - To describe the safety of Avaxim 80U Pediatric after each dose of vaccine administered 6 months apart, in subjects aged 12 months to 15 years.","other_id":"HAF87","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":1,"maximum_age":15,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Aged 12 to 185 months (approximately 15 years and 5 months) on the day of inclusion\r\n\r\n          -  Informed consent form has been signed and dated by the subject aged 12 years old and\r\n             above (based on local regulations), and informed consent form has been signed and\r\n             dated by the parent(s) or another legally acceptable representative\r\n\r\n          -  Subject and parent / legally acceptable representative are able to attend all schedule\r\n             visits and to comply with all trial procedures\r\n\r\n          -  Subjects aged less than 2 years only: Born at full term of pregnancy ( 37 weeks)\r\n             and/or with a birth weight  2.5 kg.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subject is pregnant, or lactating, or of childbearing potential (to be considered of\r\n             non-childbearing potential, a female must be pre-menarche, surgically sterile, or\r\n             using an effective method of contraception or abstinence from at least 4 weeks prior\r\n             to the first vaccination and until at least 4 weeks after the last vaccination)\r\n\r\n          -  Participation at the time of study enrollment (or in the 4 weeks preceding the first\r\n             trial vaccination) or planned participation during the present trial period in another\r\n             clinical trial investigating a vaccine, drug, medical device, or medical procedure\r\n\r\n          -  Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned\r\n             receipt of any vaccine in the 4 weeks preceding or following any trial vaccination\r\n\r\n          -  Previous vaccination against Hepatitis A with either the trial vaccine or another\r\n             Hepatitis A vaccine\r\n\r\n          -  Receipt of immune globulins, blood or blood-derived products in the past 3 months\r\n\r\n          -  Known or suspected congenital or acquired immunodeficiency; or receipt of\r\n             immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy,\r\n             within the preceding 6 months; or long-term systemic corticosteroid therapy\r\n             (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)\r\n\r\n          -  History of Hepatitis A infection, confirmed either clinically, serologically, or\r\n             microbiologically\r\n\r\n          -  At high risk for hepatitis A infection during the trial\r\n\r\n          -  Known systemic hypersensitivity to any of the vaccine components, or history of a\r\n             life-threatening reaction to the vaccine used in the trial or to a vaccine containing\r\n             any of the same substances\r\n\r\n          -  Self-reported thrombocytopenia, contraindicating intramuscular vaccination\r\n\r\n          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,\r\n             contraindicating intramuscular vaccination\r\n\r\n          -  Deprived of freedom by an administrative or court order, or in an emergency setting,\r\n             or hospitalized involuntarily\r\n\r\n          -  Current alcohol abuse or drug addiction\r\n\r\n          -  Chronic illness that, in the opinion of the investigator, is at a stage where it might\r\n             interfere with trial conduct or completion\r\n\r\n          -  Moderate or severe acute illness / infection (according to investigator judgment) on\r\n             the day of vaccination or febrile illness (axillary temperature  37.1C). A\r\n             prospective subject should not be included in the study until the condition has\r\n             resolved or the febrile event has subsided\r\n\r\n          -  Identified as an Investigator or employee of the Investigator or study center with\r\n             direct involvement in the proposed study, or identified as an immediate family member\r\n             (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with\r\n             direct involvement in the proposed study.\r\n      ","sponsor":"Sanofi Pasteur, a Sanofi Company","sponsor_type":"Industry","conditions":"Hepatitis A|Hepatitis A Virus","interventions":[{"intervention_type":"Biological","name":"Biological: Avaxim 80U Pediatric: Inactivated Hepatitis A Virus","description":"0.5 mL, Intramuscular (2 injection 6 months apart)"}],"outcomes":[{"outcome_type":"primary","measure":"Number of participants reporting solicited injection site and systemic events and unsolicited adverse events following vaccination with Avaxim® 80U Pediatric (Inactivated Hepatitis A vaccine).","time_frame":"Day 0 up to Day 30 post vaccination","description":"Participants aged ≤ 23 months, Solicited injection site reactions: Tenderness, Redness, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Participants 2 to 15 Years of Age: Solicited injection site reactions: Pain, Redness, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia. Unsolicited adverse events, including serious adverse events will also be collected for all participants"}]}
{"nct_id":"NCT02005536","start_date":"2013-12-31","phase":"Phase 4","enrollment":60,"brief_title":"Study of IMOVAX POLIO Subcutaneous as a Booster Vaccine in Pre-school Age Children in Japan","official_title":"Immunogenicity and Safety of IMOVAX POLIO Subcutaneous as a Booster Given in Pre-school Age Children in Japan","primary_completion_date":"2014-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-10-31","last_update":"2015-03-30","description":"The aim of the study is to assess the immunogenicity of SP059 (IMOVAX POLIO: Inactive Poliovirus Vaccine) vaccine against poliovirus and safety after fifth dose. Primary Objective: - To investigate the booster vaccine response rate against poliovirus types 1, 2 and 3 one month following the vaccination dose with SP059 as 2nd booster Secondary Objectives: - To investigate seroprotection rates (percentage of subjects presenting poliovirus neutralizing antibody titers above 1:8 (1/dil.) at pre- and post-booster time points, Geometric mean titers (GMT) at pre- and post-booster time points and geometric mean of individual titer ratio (GMTR). - To investigate the safety after dosing of SP059 as 2nd booster.","other_id":"IPV46 (EFC13614)","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":4,"maximum_age":6,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Aged 4 to 6 years inclusive on the day of inclusion\r\n\r\n          -  Subjects who received 4 times an IPV-containing vaccine (DTaP-IPV or IPV) during first\r\n             (3 doses) and second year of life (one dose)\r\n\r\n          -  Informed consent form signed by the parent(s) or other legal representative\r\n\r\n          -  Able to attend all scheduled visits and to comply with all trial procedures.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Fever  37.5C (axillary temperature) on the day of inclusion\r\n\r\n          -  Any serious disease whether acute or chronic\r\n\r\n          -  Past or current medical history of Guillain-Barre syndrome, acute thrombocytopenic\r\n             purpura or encephalopathy\r\n\r\n          -  History of poliomyelitis infection\r\n\r\n          -  History of a life threatening reaction to a vaccine containing the same substances of\r\n             the study vaccine\r\n\r\n          -  History of anaphylaxis or allergy to any of the study vaccine components\r\n\r\n          -  Congenital or current/previous acquired immunodeficiency, immunosuppressive therapy\r\n             such as long-term systemic corticosteroids therapy\r\n\r\n          -  Participation in another clinical trial within 6 months before the trial inclusion\r\n\r\n          -  Planned participation in another clinical trial during the present trial period\r\n\r\n          -  Received oral or injected antibiotic therapy within the 72 hours prior to any blood\r\n             draw\r\n\r\n          -  Received antipyretics/analgesics/Non-steroidal anti-inflammatory drugs (considered as\r\n             a single category) within 4 hours prior to vaccination\r\n\r\n          -  Blood or blood-derived products received in the past or current or planned\r\n             administration during the trial (including immunoglobulins)\r\n\r\n          -  Any vaccination with live vaccines within the past 27 days preceding the trial\r\n             vaccination\r\n\r\n          -  Any vaccination with inactivated vaccines within the past 6 days preceding the trial\r\n             vaccination\r\n\r\n          -  Clinical or known serological evidence of systemic illness including Hepatitis B,\r\n             Hepatitis C and/or HIV infection\r\n\r\n          -  Subject ineligible according to the Investigator's clinical judgment.\r\n      ","sponsor":"Sanofi Pasteur, a Sanofi Company","sponsor_type":"Industry","conditions":"Poliomyelitis|Polio","interventions":[{"intervention_type":"Biological","name":"Biological: IMOVAX POLIO: Inactive Poliovirus Vaccine","description":"0.5 mL, Subcutaneous"}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of Participants With Booster Responses Against Polio Antigens Following Vaccination With IMOVAX POLIO®","time_frame":"Day 28 post-vaccination","description":"A booster response was defined as a 4-fold increase from pre-booster to post-booster vaccination. Anti-polio virus antibodies were assessed by virus neutralization assay."},{"outcome_type":"secondary","measure":"Geometric Mean Titers of Vaccine Antigens Before and After Vaccination With IMOVAX POLIO®","time_frame":"Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination","description":"Anti-polio virus antibodies were assessed by virus neutralization assay."},{"outcome_type":"secondary","measure":"Percentage of Participants With Seroprotection Against Polio Antigens Before and After Booster Vaccination With IMOVAX POLIO®","time_frame":"Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination","description":"Seroprotection was defined as a titer of ≥ 8 (1/dil) pre-booster or post-booster vaccination. Anti-polio virus antibodies were assessed by virus neutralization assay"},{"outcome_type":"secondary","measure":"Geometric Mean of Individual Titer Ratios of Vaccine Antigens Following Booster Vaccination With IMOVAX POLIO®","time_frame":"Day 28 post-booster vaccination","description":"Anti-polio virus anti-bodies were assessed by virus neutralization assay. The geometric mean titer ratio is the post-booster to pre-booster geometric mean ratio values."},{"outcome_type":"secondary","measure":"Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO®","time_frame":"Day 0 up to Day 7 post-vaccination","description":"Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Fever, Headache, Malaise, Myalgia. Grade 3 was defined as incapacitating, unable to perform usual activities for Pain; diameter ≥ 50 mm for Erythema and Swelling; Temperature ≥ 39.0°C for Fever; and significant, prevents daily activity for Headache, Malaise, and Myalgia."}]}
{"nct_id":"NCT02269852","start_date":"2013-12-31","phase":"Phase 4","enrollment":182,"brief_title":"The Immunogenicity and Safety of 2013-2014 Seasonal Trivalent Influenza Vaccine","official_title":"A Single-centered, Open-labeled, Phase 4 Study of a Northern Hemisphere 2013-2014 Seasonal Trivalent Influenza Inactivated Vaccine, Anflu","primary_completion_date":"2014-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-06-30","last_update":"2015-09-21","description":"The purpose of this study is to evaluate the immunogenicity and safety of Northern hemisphere 2013-2014 seasonal trivalent inactivated influenza vaccine in 60 healthy infants aged 6-35 months old, 60 healthy adults aged 18-60 years old, and 60 healthy seniors aged > 60 years.","other_id":"PRO-INF-4013","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":0.5,"population":"","criteria":"\n        For adults and seniors:\r\n\r\n        Inclusion Criteria:\r\n\r\n          -  Healthy adults aged 18-60 years old, and healthy seniors aged > 60 years old;\r\n\r\n          -  Without vaccination history of seasonal split influenza vaccine in the recent 3 years\r\n\r\n          -  No traveling plan during the study period of this trial;\r\n\r\n          -  Be able to understand and sign the informed consent;\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Allergic to egg products or any ingredient of the study vaccine;\r\n\r\n          -  Fever, influenza or acute illness on the vaccination day;\r\n\r\n          -  Acute stage of chronic illness;\r\n\r\n          -  Malignant tumor;\r\n\r\n          -  Immunodeficiency, includes HIV infection;\r\n\r\n          -  Guillain-Barre syndrome;\r\n\r\n          -  Administration of live attenuated vaccine within the previous 14 days;\r\n\r\n          -  Administration of subunit or inactivated vaccine within the previous 7 days;\r\n\r\n          -  Planned to participate in any other clinical trial of drug or vaccine during this\r\n             study;\r\n\r\n          -  Received immunesuppressive treatment within the previous month, or planned for such\r\n             treatment during this study;\r\n\r\n          -  Pregnant, or planning pregnancy;\r\n\r\n          -  Axillary temperature > 37.0;\r\n\r\n          -  Any other factors that, in the judgment of the investigator, is unsuitable for this\r\n             study;\r\n\r\n        For infants:\r\n\r\n        Inclusion Criteria:\r\n\r\n          -  Healthy male or female aged between 6 and 35 months;\r\n\r\n          -  Full-term birth, birth weight 2,500 grams or more;\r\n\r\n          -  Provided birth certification or vaccination card\r\n\r\n          -  Parent or legal guardian is able to understand and sign the informed consent;\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Received seasonal influenza vaccine after June 30, 2012;\r\n\r\n          -  Acute infection within the previous week;\r\n\r\n          -  Allergy history, or allergic to any ingredient of the study vaccine, such as egg;\r\n\r\n          -  History of serious adverse reaction (SAR) to vaccine;\r\n\r\n          -  Autoimmune disease or immune deficiency, or administration of immunosuppressive\r\n             therapy, cell toxic therapy, or inhaled corticosteroid within the previous 6 months;\r\n\r\n          -  Congenital malformations, developmental disorder or serious chronic disease;\r\n\r\n          -  Unstable condition of asthma and administration of corticosteroid in the most recent\r\n             two years;\r\n\r\n          -  Coagulation abnormalities or disorders;\r\n\r\n          -  History/ family history of infantile convulsion, epilepsy, cerebropathy, or mental\r\n             disease;\r\n\r\n          -  Without spleen;\r\n\r\n          -  Severe neurological diseases, such as Guillain-Barre syndrome;\r\n\r\n          -  Administration of blood products or investigational drug within the previous month;\r\n\r\n          -  Administration of live attenuated vaccine within the previous 14 days;\r\n\r\n          -  Administration of subunit or inactivated vaccine within the previous 7 days;\r\n\r\n          -  Received treatment for allergy within the previous 14 days;\r\n\r\n          -  on-going anti-tuberculosis therapy;\r\n\r\n          -  Axillary temperature > 37.0 immediately before vaccination;\r\n\r\n          -  any other factors that, in the judgment of the investigator, is unsuitable for this\r\n             study;\r\n      ","sponsor":"Sinovac Biotech Co., Ltd","sponsor_type":"Industry","conditions":"Influenza","interventions":[{"intervention_type":"Biological","name":"Biological: trivalent seasonal influenza vaccine","description":"Infants: 0.25 ml/ dose;\r\nAdults: 0.5 ml/ dose;\r\nSeniors: 0.5 ml/ dose;"}],"outcomes":[{"outcome_type":"primary","measure":"The immunogenicity of 2013-2014 seasonal trivalent vaccine (TIV) in adults and seniors","time_frame":"21 days after vaccination","description":"To evaluate the immune responses to each antigen of the 2013-2014 seasonal TIV in adults and seniors by detection of hemagglutination inhibition (HI) antibody titer"},{"outcome_type":"secondary","measure":"The incidences of adverse events (AEs) in infants, adults and seniors","time_frame":"Day 0 - day 35","description":"After each injection, a 30-minute safety observation was conducted immediately, and the body temperature, occurrence of solicited local and general AEs within 72 hours were collected. Unsolicited AEs of adults and seniors were collected until day 21, and those of infants were collected until day 35. Each AE case was reviewed by the investigator to determine whether or not it was an adverse reaction (related to the vaccination)."},{"outcome_type":"secondary","measure":"The cross-reactivity of 2013-2014 seasonal TIV in adults and seniors against influenza B Victoria lineage virus and the avian influenza A(H7N9) virus","time_frame":"21 days after vaccination","description":"To evaluate the cross-reactivity of 2013-2014 seasonal TIV in adults and seniors against influenza B Victoria lineage virus (not in the vaccine formulation) and the avian influenza A(H7N9) virus by detection of HI antibody titer"}]}
{"nct_id":"NCT02070614","start_date":"2013-12-31","enrollment":72,"brief_title":"Association of CYP3A4 rs2242480 With Sufentanil Plasma Concentration and PCA Consumption","official_title":"Association of CYP3A4 rs2242480 With Sufentanil Plasma Concentration and PCA Consumption","primary_completion_date":"2014-03-31","study_type":"Observational","rec_status":"Completed","completion_date":"2014-05-31","last_update":"2015-09-01","description":"This study was designed for exploring the association of cytochrome P450 3A4 rs2242480 polymorphism with metabolism of sufentanil in Chinese patients receiving upper abdominal surgeryto provide evidence for genetic prediction of personalized medication.Methods:60 patients who prepared for elective upper abdominal surgery under general anesthesia were recruited into study. Liver enzyme inhibitor should be excluded in anesthesia. rs2242480 genotyping was carried out by direct sequencing. The blood samples were drawn before anesthesia30 min and 45min after anesthesia respectivelyused for plasma sufentanil concentration detection with high performance liquid chromatography-mass spectrometry (HPLC-MS). After surgerythe patients received patient-controlled intravenous sufentanil immediately. And postoperative pain at restsufentanil consumptionside effects and rescue analgesic requirements were recorded at the 6th12th24th hour. The plasma sufentanil concentration and PCA sufentanil consumption were analyzed to investigate the differences among rs2242480 three genotypes.","other_id":"CYP3A4 and sufentanil","observational_model":"Cohort","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":65,"population":"60 Chinese male and female patients receiving elective upper abdominal surgery (liver,\r\n        pancreatic, gallbladder) under general anesthesia","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  1.American Society of Anesthesiologists (ASA) physical status I or II 2.age from 18 to\r\n             65 years old 3.BMI of 1926kg/m2\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  1.known history of chronic pain, psychiatric diseases, diabetes mellitus, severe\r\n             cardiovascular diseases, kidney or liver diseases with poor hepatic function 2.alcohol\r\n             or drug abuse (according to the criteria of Diagnostic and Statistical Manual of\r\n             Mental Disorders-IV) 3.pregnancy or at lactation period 4.Patients who consumed drugs\r\n             (1 week) or foods (3 days) known to inhibit or induce the expression of cytochrome\r\n             P450 3A4 enzymes prior to surgery were also excluded. The following drugs or foods\r\n             included but were not limited to erythromycin, clarithromycin, alcohol, chocolate,\r\n             coffee, grapefruit juice, verapamil, rifampicin, HIV protease inhibitors,\r\n             phenytoin,itraconazole, dexamethasone, phenobarbital, and carbamazepine.\r\n      ","sponsor":"Xianwei Zhang","sponsor_type":"Other","conditions":"Surgery|Individuality","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"the correlation between rs2242480 polymorphism and sufentanil metabolism","time_frame":"4 months","description":"according to rs2242480 genotype and plasma concentration of sufentanil"},{"outcome_type":"secondary","measure":"Variation of plasma concentration of sufentanil","time_frame":"4 months","description":"the single-dose sufentanil plasma concentration varies between participants, and the differences among 3 time-points is related with personal genotype."},{"outcome_type":"secondary","measure":"relation between rs2242480 genotype and patient-controlled analgesia(PCA) consumption of sufentanil","time_frame":"4 months","description":"according to postoperative PCA sufentanil consumption and rs2242480 genotype"},{"outcome_type":"secondary","measure":"relation between Visual Analogue Scale/Score(VAS) and rs2242480","time_frame":"4 months","description":"according to PCA VAS and rs2242480 genotype"}]}
{"nct_id":"NCT02509000","start_date":"2013-12-31","phase":"N/A","enrollment":35,"brief_title":"Beijing Indoor Air Purifier Intervention Study","official_title":"Beijing Indoor Air Purifier Intervention Study","primary_completion_date":"2014-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-11-30","last_update":"2015-10-21","description":"This study aimed to assess the impact of air filtration on indoor air quality and cardio-pulmonary health in residents living in high outdoor pollution settings in Beijing.","other_id":"WHuang14","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Health Services Research","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":40,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Global Initiative for Chronic Obstructive Lung Disease criteria (mild to moderate,\r\n             GOLD stage I~II;\r\n\r\n          -  severe to very severe, GOLD stage III~IV) quit smoking for at least 1 year;\r\n\r\n          -  a ratio of pre-bronchodilator forced expiratory volume in one second (FEV1) to forced\r\n             vital capacity (FVC) equal to or less than 0.70 and an increase of FEV1 with the use\r\n             of 400g of albuterol of less than 12% of the pre-bronchodilator one;\r\n\r\n          -  no history of asthma or any other active lung disease.\r\n\r\n          -  Subjects were free from exacerbations for at least 6 weeks.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with heart pacemaker,\r\n\r\n          -  heart failure with bundle-branch block,\r\n\r\n          -  recent myocardial infarction (in the last 12 weeks) and\r\n\r\n          -  anticoagulant therapy\r\n      ","sponsor":"WeiHuang","sponsor_type":"Other","conditions":"Pulmonary Disease","interventions":[{"intervention_type":"Other","name":"Other: air purifier","description":"filtration units randomly allocated to active- and sham-mode in 20 recruited households for four weeks"}],"outcomes":[{"outcome_type":"primary","measure":"respiratory inflammation","time_frame":"4 weeks","description":"analyzed EBC pH and inflammation biomarkers 8-isoprostane and nitrite and nitrate"},{"outcome_type":"secondary","measure":"systemic inflammation","time_frame":"4 weeks","description":"analyzed systemic inflammation biomarkers C-reaction Protein, Blood coagulation factor fibrinogen (Fib), Interleukin (IL) -8, -1β, -6, -10, -12p70 and tumor necrosis factor-α (TNF-α)"},{"outcome_type":"secondary","measure":"oxidative stress","time_frame":"4 weeks","description":"analyzed systemic oxidative stress biomarker urinary 8-hydroxy-2-deoxyguanosine (8-OHdG)"},{"outcome_type":"other","measure":"lung function","time_frame":"4 weeks","description":"lung function test (FEV1, FEV1 %predicted, FEV1/FVC, 176 maximum midexpiratory flow (MMEF), MMEF %predicted) using an Aspirometer"},{"outcome_type":"other","measure":"autonomic function","time_frame":"4 weeks","description":"twelve-hour ambulatory electrocardiogram (ECG) and blood pressure (BP) were monitored"}]}
{"nct_id":"NCT02036827","start_date":"2013-12-31","phase":"Phase 4","enrollment":108,"brief_title":"The Effect of Deep Neuromuscular Blockade on Postoperative Shoulder Tip Pain After Laparoscopic Cholecystectomy","official_title":"The Effect of Deep Neuromuscular Blockade on Postoperative Shoulder Tip Pain After Laparoscopic Cholecystectomy","primary_completion_date":"2015-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-01-31","last_update":"2015-02-09","description":"The purpose of this study was to investigate whether there is any difference in incidence of shoulder tip pain after laparoscopic cholecystectomy between the groups with moderate neuromuscular block and deep neuromuscular block.","other_id":"3-2013-0210","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":20,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  physical status by American society of Anesthesiology; 1 or 2 patients\r\n\r\n          -  patients with benign gallbladder disease scheduled for laparoscopic cholecystectomy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  patient with myasthenia gravis\r\n\r\n          -  allergy to rocuronium or sugammadex\r\n\r\n          -  patient with shoulder pain disease (Ex. rotator cuff tear)\r\n\r\n          -  psychological disease\r\n\r\n          -  patients who cannot understand Korean\r\n      ","sponsor":"Yonsei University","sponsor_type":"Other","conditions":"Pain, Postoperative","interventions":[{"intervention_type":"Drug","name":"Drug: Rocuronium","description":"We will administrate neuromuscular blocking agent until moderate or deep neuromuscular blockade stabilized."}],"outcomes":[{"outcome_type":"primary","measure":"Shoulder tip pain","time_frame":"upto postoperative 24 hours","description":"The severity of shoulder tip pain will be measured in PACU and upto postoperative 6, 6-12, 12-24 hours."},{"outcome_type":"secondary","measure":"Postoperative pain","time_frame":"upto postoperative 24 hours","description":"The severity and the location of postoperative pain will be measured in PACU and upto postoperative 6, 6-12, 12-24 hours after operation."},{"outcome_type":"secondary","measure":"Postoperative nausea and vomiting","time_frame":"upto postoperative 24hours","description":"The severity of nausea, the number of vomiting and the dose and number of administration of rescue antiemetics will be recorded."},{"outcome_type":"secondary","measure":"Intraoperative hemodynamics","time_frame":"upto postoperative 24hours","description":"Heart rate and blood pressure will be measured at the completion of anesthetic induction, at the completion of carbon dioxide insufflation, at 15 minutes after carbon dioxide insufflation, at the completion of desufflation of pneumoperitoneum, and at the completion of operation."},{"outcome_type":"secondary","measure":"pulmonary compliance","time_frame":"upto postoperative 24 hours","description":"Total lung compliance will be measured by the equation : CT (L/cm H2O) = change in volume/ change in pleural pressure It will be measured at the completion of anesthetic induction, at the completion of carbon dioxide insufflation, at 15 minutes after carbon dioxide insufflation, at the completion of desufflation of pneumoperitoneum, and at the completion of operation"},{"outcome_type":"secondary","measure":"Satisfaction of the surgeon","time_frame":"upto postoperative 24 hours","description":"Satisfaction of the surgeon will be measured by 5-scale numeric rating scale) at the completion of surgery."},{"outcome_type":"secondary","measure":"Working intrabdominal space","time_frame":"upto postoperative 24 hours","description":"Working intrabdominal space will be measured by grasper (from skin to sacral promontory) at the completion of carbon dioxide insufflation."}]}
{"nct_id":"NCT03100097","start_date":"2013-12-16","phase":"N/A","enrollment":62,"brief_title":"A Prospective, Multicenter, Randomized Control Study To Determine Clinical Effectiveness, Patient Wellness and Cost of Pain Related Care of In-Elastic Lumbar Sacral Orthoses Versus Standard Medical Treatment in Patients Presenting With Acute Low Back Pain In Primary Care Centers (The ARREST Study)","official_title":"A Prospective, Multicenter, Randomized Control Study To Determine Clinical Effectiveness, Patient Wellness and Cost of Pain Related Care of In-Elastic Lumbar Sacral Orthoses Versus Standard Medical Treatment in Patients Presenting With Acute Low Back Pain In Primary Care Centers","primary_completion_date":"2017-06-30","study_type":"Interventional","rec_status":"Terminated","completion_date":"2017-12-31","last_update":"2018-01-12","description":"The objective of this study is to evaluate sixty male and non-pregnant female patients diagnosed with acute moderate to severe low back pain with the onset of symptoms within 30 days. To evaluate functional improvement following a 4-week use of an in-elastic lumbar sacral orthosis (LSO) as a treatment modality for acute low back pain.","other_id":"CPR-ORTHO02-2013","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":19,"population":"","criteria":"\n        -  Inclusion Criteria:\r\n\r\n             o Moderate to complete disability (baseline ODI score of 21 to 80 percent)\r\n\r\n          -  Exclusion Criteria:\r\n\r\n               -  Pregnant patients\r\n\r\n               -  Patients considering pregnancy\r\n\r\n               -  Patients in any other investigational device or drug study\r\n\r\n               -  Patients unwilling to return for follow up\r\n\r\n               -  Patients unwilling to provide access to medical claims associated with pain\r\n                  management.\r\n      ","sponsor":"Aspen Medical Products","sponsor_type":"Other","conditions":"Back Pain|Low Back Pain","interventions":[{"intervention_type":"Device","name":"Device: Aspen Horizon 627 LSO"}],"outcomes":[{"outcome_type":"primary","measure":"40% change in Oswestry Disability Index","time_frame":"4 weeks","description":"Oswestry Disability Index"},{"outcome_type":"secondary","measure":"Change in Opioid utilization","time_frame":"4 weeks, 8 weeks, 12 weeks","description":"Change in Opioid utilization"},{"outcome_type":"secondary","measure":"Number of participants with treatment-related adverse events as assessed by questionnaire","time_frame":"4 weeks, 8 weeks, 12 weeks","description":"Were any complications associated wearing of the brace noted in patients questionnaires"},{"outcome_type":"secondary","measure":"General Health Survey","time_frame":"12 weeks","description":"SF36v2 Health Survey"}]}
{"nct_id":"NCT02013297","start_date":"2013-12-03","phase":"N/A","enrollment":80,"brief_title":"Study of SBRT Efficacy on Intra and Extra -Cranial Tumors or Metastasis in Pediatrics Population (SBRT Pediatrics)","official_title":"Hypofractionated Stereotactic Radiation Treatments (SBRT) on Children, Teenagers and Young Adults Malignant Tumors","primary_completion_date":"2020-03-26","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2021-09-21","last_update":"2021-07-28","description":"The purpose of this study is to evaluate the efficacy of hypofractionated stereotactic radiation treatments (SBRT) on children, teenagers and young adults malignant tumors.","other_id":"SBRT","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":1.5,"maximum_age":20,"population":"","criteria":"\n        INCLUSION CRITERIA:\r\n\r\n          -  18 months  age  20 years\r\n\r\n          -  Malignant primary tumor, histologically or cytologically proven\r\n\r\n          -  Systemic disease under control or with slow evolution\r\n\r\n          -  Written indication of SBRT according to local pediatrics meeting and national\r\n             Radiotherapy (RT) web conference\r\n\r\n          -  Performance Status  2 according to Eastern Cooperative Oncology Group (ECOG)\r\n\r\n          -  Sites\r\n\r\n               -  Brain metastasis ( 3 on MRI) not suitable for surgery, without hemorrhage, less\r\n                  than 3 cm each, not in the brain stem\r\n\r\n               -  Primary or secondary spinal/para spinal metastasis ( 3), not suitable for\r\n                  surgery or with a non operable macroscopic residue, less than 5 cm\r\n\r\n               -  Lung metastasis ( 3), less than 5 cm, not eligible for surgery, or macroscopic\r\n                  residue not suitable for surgery\r\n\r\n               -  Previously irradiated relapsing isolated primitive/secondary tumor (intra cranial\r\n                  or extra cranial), with no possible surgery, or macroscopic residue.\r\n\r\n          -  Affiliation to a social security scheme\r\n\r\n          -  Signed Informed consent by patient or parents.\r\n\r\n        IN ADDITION FOR RELAPSING EPENDYMOMA:\r\n\r\n          -  Histologically proven local ependymoma at diagnosis\r\n\r\n          -  Previously irradiated ependymoma\r\n\r\n          -  Exclusive local relapse in previously irradiated site\r\n\r\n          -  Review of operability at time of relapse by a multidisciplinary staff\r\n\r\n          -  Relapse must be confirmed by a neuro-oncology multidisciplinary staff, on MRI\r\n             evolutivity characteristics\r\n\r\n          -  Time to relapse after previous irradiation  1 year\r\n\r\n        NON-INCLUSION CRITERIA :\r\n\r\n          -  Concomitant chemotherapy\r\n\r\n          -  No evaluable target\r\n\r\n          -  Pregnancy\r\n\r\n          -  Follow-up impossible\r\n\r\n        IN ADDITION FOR RELAPSING EPENDYMOMAS:\r\n\r\n          -  Metastatic patient at diagnosis and/or at relapse\r\n\r\n          -  Complete remission never obtained\r\n\r\n        NON-RANDOMIZATION DOSIMETRIC CRITERIA (ONLY FOR EPENDYMOMA)\r\n\r\n          -  Cumulative doses to brain stem  115 Gy\r\n\r\n          -  Tumor volume at relapse  30 cm3\r\n\r\n          -  Primary RT dose + Re-irradiation dose more than 112 Gy\r\n\r\n          -  Cumulative dose to the chiasma > 54 Gy\r\n\r\n          -  Cumulative dose to any point of the brain > 115 Gy\r\n      ","sponsor":"Centre Leon Berard","sponsor_type":"Other","conditions":"Brain Metastasis|Spinal Tumors|Lung Tumors|Ependymoma","interventions":[{"intervention_type":"Radiation","name":"Radiation: SBRT treatment","description":"For Brain metastasis the SBRT treatment consists on 3 fractions of 8 Gy or 5 fractions of 7 Gy or 1 fraction of 18 Gy for a single metastasis which is less than 20 mm.\r\nFor primary or secondary pulmonary tumors the SBRT treatment consists on 3 fractions of 15 Gy or 5 fractions of 10 Gy for peripheral lesions and on 5 fractions of 8 Gy for proximal lesions.\r\nFor primary or secondary spinal or para-spinal tumors the SBRT treatment consists on 3 fractions of 9 Gy or 5 fractions of 7 Gy.\r\nFor previously irradiated tumors (same locations) the SBRT treatment consists on 5 to 8 fractions of 5 Gy.\r\nFor relapsed Ependymoma previously irradiated the SBRT treatment will be allocated by surgical stratified randomization and consists on either 3 fractions of 8 Gy or 5 fractions of 5 Gy."}],"outcomes":[{"outcome_type":"primary","measure":"Efficacy of SBRT assessed 6 months after treatment","time_frame":"6 months after inclusion","description":"The treatment efficacy is assessed by calculation of local control rate of irradiated locations according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria (complete response + partial response + stable disease)"},{"outcome_type":"secondary","measure":"Efficacy of SBRT assessed between 1,5 and 3 months after treatment","time_frame":"Between 1,5 and 3 months after inclusion","description":"The treatment efficacy is assessed by calculation of local control rate of irradiated locations according to RECIST version 1.1 criteria (complete response + partial response + stable disease) between 1,5 and 3 months after treatment"},{"outcome_type":"secondary","measure":"Progressive Free Survival","time_frame":"From the date of inclusion to the date of progression","description":"Calculated from the date of inclusion to the date defined as the first documented disease progression, or second cancer appearance, or death from any cause (Up to 5 years since the first inclusion)"},{"outcome_type":"secondary","measure":"Overall Survival","time_frame":"From the date of inclusion to the date of death (Up to 5 years since the first inclusion)","description":"Calculated from the date of inclusion to the date of death from any cause (Up to 5 years since the first inclusion)"},{"outcome_type":"secondary","measure":"Short time Safety profile of SBRT","time_frame":"From inclusion to 3 months after inclusion","description":"Toxicities appeared during SBRT treatment and up to 3 months after SBRT. Toxicities will be assessed by the evaluation of intensity and incidence of the Adverse Events (AE) displayed by patients. The intensity of each AE will be classified according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0"},{"outcome_type":"secondary","measure":"Long term Safety profile of SBRT","time_frame":"after 24 months after inclusion","description":"Toxicities appeared after 24 months after inclusion. The outcome measure concerns toxicities appeared after the study following period. Toxicities will be assessed by the evaluation of intensity and incidence of the Adverse Events (AE) displayed by patients. The intensity of each AE will be classified according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0"},{"outcome_type":"secondary","measure":"Efficacy of SBRT assessed 12 months after treatment","time_frame":"12 months after inclusion","description":"The treatment efficacy is assessed by calculation of local control rate of irradiated locations according to RECIST version 1.1 criteria (complete response + partial response + stable disease) at 12 months after treatment"},{"outcome_type":"secondary","measure":"Efficacy of SBRT assessed 24 months after treatment","time_frame":"24 months after inclusion","description":"The treatment efficacy is assessed by calculation of local control rate of irradiated locations according to RECIST version 1.1 criteria (complete response + partial response + stable disease) at 24 months after treatment"},{"outcome_type":"secondary","measure":"Medium time Safety profile of SBRT","time_frame":"Between 3 months and 24 months after inclusion","description":"Toxicities appeared between 3 months and 24 months after treatment. Toxicities will be assessed by the evaluation of intensity and incidence of the Adverse Events (AE) displayed by patients. The intensity of each AE will be classified according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0"},{"outcome_type":"other","measure":"SBRT treatment and toxicities related costs for 6 months after SBRT","time_frame":"6 months after inclusion","description":"The SBRT treatment related costs will be evaluated by a \"microcosting\" method which take into account, in particular, the irradiation duration seance, the time for the mobilized staff, the kind of equipment required, the duration of related AE hospitalizations."},{"outcome_type":"other","measure":"Cost/Efficacy ratio between 2 modalities of SBRT treatment of ependymoma at 6 months after treatment","time_frame":"6 months after inclusion","description":"2 modalities of SBRT are compared in patients with an ependymoma (3 fractions of 8 Gy versus 5 fractions of 5 Gy). It will be calculated the cost/efficacity ratio for the avoided toxicity 6 months after SBRT.\r\nThe costs will be evaluated by the data from french social security system, from homogeneous group of patients and from general classification of professional acts"},{"outcome_type":"other","measure":"Cost/Efficacy ratio between 2 modalities of SBRT treatment of ependymoma at 12 months after treatment","time_frame":"12 months after inclusion","description":"2 modalities of SBRT are compared in patients with an ependymoma (3 fractions of 8 Gy versus 5 fractions of 5 Gy). It will be calculated :\r\nthe cost/efficacity per gained year of life without relapse after 12 months after SBRT\r\nthe cost/efficacity per gained year of life without disease after 12 months after SBRT.\r\nThe costs will be evaluated by the data from french social security system, from homogeneous group of patients and from general classification of professional acts"},{"outcome_type":"other","measure":"Cost/Efficacy ratio between 2 modalities of SBRT treatment of ependymoma at 24 months after treatment","time_frame":"24 months after inclusion","description":"2 modalities of SBRT are compared in patients with an ependymoma (3 fractions of 8 Gy versus 5 fractions of 5 Gy). It will be calculated :\r\nthe cost/efficacity per gained year of life without relapse after 24 months after SBRT\r\nthe cost/efficacity per gained year of life without disease after 24 months after SBRT.\r\nThe costs will be evaluated by the data from french social security system, from homogeneous group of patients and from general classification of professional acts"}]}
{"nct_id":"NCT02066324","start_date":"2013-11-30","enrollment":25,"brief_title":"Urine Sample Collection From FOP Patients","official_title":"Urine Sample Collection From Patients With Fibrodysplasia Ossificans Progressiva (FOP) for Biomarker Analysis","primary_completion_date":"2014-08-31","study_type":"Observational","rec_status":"Completed","completion_date":"2014-08-31","last_update":"2015-03-12","description":"The purpose of this study is to collect urine samples from patients with fibrodysplasia ossificans progressiva (FOP) for the assessment of biomarkers related to disease, disease progression and for prediction of flare-ups of the disease. Disease related biomarkers in these patients are currently unknown. This study aims to support the development of novel therapy/ies for this disease.","other_id":"CPJMR0062203","sampling_method":"Probability Sample","gender":"All","minimum_age":5,"maximum_age":35,"population":"Patients with Fibrodysplasia Ossificans Progressiva.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male and female patients  5 and  35 years of age with a diagnosis of FOP.\r\n\r\n          -  Physically able to provide first-morning urine sample of at least 30 mL\r\n\r\n          -  Able to communicate well with the investigator, to understand and comply with the\r\n             requirements of the study\r\n\r\n          -  About half of the patients enrolled should have a flare-up, which is defined as an\r\n             acute exacerbation of disease activity characterized by two or more of the following\r\n             symptoms: pain, swelling, decreased range of motion, impaired function\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Diagnosis of diabetes\r\n\r\n          -  Diagnosis of other systemic inflammatory disorder (juvenile idiopathic arthritis,\r\n             systemic lupus erythematosus, etc.)\r\n\r\n          -  Diagnosis of cancer other than nonmelanomatous skin cancer.\r\n      ","sponsor":"Novartis Pharmaceuticals","sponsor_type":"Industry","conditions":"Fibrodysplasia Ossificans Progressiva","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Analysis of pre-defined biomarker FGF2","time_frame":"3 months","description":"The objective of this study is to collect urine samples from patients with FOP over a time period covering ideally quiescent disease status and progression through a flare-up for biomarker analysis"},{"outcome_type":"primary","measure":"Analysis of pre-defined biomarker WEGF","time_frame":"3 months","description":"The objective of this study is to collect urine samples from patients with FOP over a time period covering ideally quiescent disease status and progression through a flare-up for biomarker analysis"},{"outcome_type":"primary","measure":"Analysis of microRNAs","time_frame":"3 months","description":"The objective of this study is to collect urine samples from patients with FOP over a time period covering ideally quiescent disease status and progression through a flare-up for biomarker analysis"}]}
{"nct_id":"NCT02128178","start_date":"2013-11-30","phase":"Phase 1/Phase 2","enrollment":700,"brief_title":"Laparoscopic Bariatric Surgery: Two Regimens of Venous Thromboprophylaxis: Prospective Randomized Study","official_title":"Laparoscopic Bariatric Surgery: Two Regimens of Venous Thromboprophylaxis: Prospective Randomized Study","primary_completion_date":"2016-04-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2016-05-31","last_update":"2015-04-08","description":"Obese patients undergoing bariatric surgery warrant VTE prophylaxis because they are at high risk for developing a fatal pulmonary embolism or postthrombotic syndrome. However, a consensus does not exist on the most effective prophylactic approach.","other_id":"Enoxaparin","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  BMI >40 OR >35 with comorbidities\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  No\r\n      ","sponsor":"Mansoura University","sponsor_type":"Other","conditions":"Morbid Obesity|Pulmonary Embolism","interventions":[{"intervention_type":"Drug","name":"Drug: Enoxaparin 40 mg 2 hours before arm","description":"Enoxaparin 40 mg 2 hours before surgery"},{"intervention_type":"Drug","name":"Drug: Enoxaparin 40 mg 12 hours before arm","description":"Enoxaparin 40 mg 12 hours before surgery"}],"outcomes":[{"outcome_type":"primary","measure":"Venous thrombosis and/or pulmonary embolism (PE)","time_frame":"Postoperative 4 weeks","description":"To assess the venous thrombosis by compression ultrasonography and PE in suspected patients"},{"outcome_type":"secondary","measure":"Bleeding from the surgery site , drain if any, GIT bleeding,","time_frame":"postoperative 4 weeks","description":"Bleeding from drain, GIT, or wounds are assessed clinically"},{"outcome_type":"secondary","measure":"hospital stay","time_frame":"4 WEEKS","description":"hospital stay in days"}]}
{"nct_id":"NCT01922167","start_date":"2013-11-30","phase":"N/A","enrollment":19,"brief_title":"Resistance Exercise Training and Amino Acid Leucine Supplementation in Frail Elderly Women","official_title":"The Impact of Exercise Training and Leucine Supplementation in Frail Elderly Women With an Exploration Into Mechanistic Explanations","primary_completion_date":"2018-02-08","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-12-17","last_update":"2019-03-08","description":"Frailty is a clinical entity associated with an increase in risk for disease and death and becomes more common as people age. Frailty has a strong relationship with the age-related loss of muscle and strength, termed sarcopenia. Sarcopenia and frailty are strongly associated with disability, especially in women. Adequate protein intake, the amino acid leucine, and resistance exercise training have been individually shown to increase muscle mass to varying degrees. However, no studies have investigated how a longer-term resistance exercise training program with leucine supplementation when protein intake is optimized could increase muscle mass in frail and pre-frail elderly women. In addition, this is the population that stands the most to gain from such an intervention. The purpose of this study is to investigate the effects of the amino acid leucine added to resistance exercise training on muscle mass and physical performance in frail and pre-frail elderly women with adequate protein intake. We hypothesize that combining leucine in diet with an exercise program would be superior to exercise alone in stimulating muscle protein synthesis and phosphorylation status of muscle cellular key-regulatory proteins, leading to enhanced gains in muscle performance. A total of 24 subjects will take part in this study, conducted at the McGill University Health Centre (MUHC) Royal Victoria Hospital and the Institut Universitaire de Griatrie de Montral (IUGM). All subjects will undergo adjustments to their diet to optimize protein intake and a resistance exercise training program. Half of the participants will receive a supplement of powdered leucine (an amino acid), and the other half of the participants will receive a placebo in the same powder form. Neither the participants nor the study investigators will know which participants are receiving the leucine nor which are receiving the placebo. Each subjects participation in this study will involve 4 total visits: 2 initial screening visits followed by 2 two-day stays at the Centre for Innovative Medicine (CIM) of the MUHC-Royal Victoria Hospital. These two stays will be spaced by 12 weeks of the intervention (dietary adjustments, resistance exercise training, and the powdered supplement). The two stays each consist of a meal test to assess each subjects metabolic responses to a meal, and to obtain muscle biopsies necessary to measure the rate of protein accumulation in the muscle. Simple physical performance measurements will be taken before and at the completion of the intervention. This study aims to better understand how the presence of aging affects the body's responses to resistance exercise and how leucine, one of the amino acids that make up proteins, may help build muscle. This in turn, could lead to defining combined diet and exercise strategies to prevent muscle loss often seen with aging.","other_id":"MUHC-H-5461","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"Quadruple","sampling_method":"","gender":"Female","minimum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Mini Mental State Examination score > 24\r\n\r\n          -  Time up and go test < 17 s\r\n\r\n          -  Stable weight and diet\r\n\r\n          -  No acute disease\r\n\r\n          -  Body mass index (BMI) 20-35 kg/m^2\r\n\r\n          -  Normal complete blood count (CBC), biochemistry, glycated hemoglobin (A1C), lipid\r\n             profile, thyroid stimulating hormone (TSH)\r\n\r\n          -  Non-diabetic (Oral Glucose Tolerance Test)\r\n\r\n          -  Negative serology for hepatitis and human immunodeficiency virus (HIV)\r\n\r\n          -  Normal chest X-Ray, electrocardiogram (ECG) and urine analysis\r\n\r\n          -  Non-disabled\r\n\r\n          -  Provide informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Eating disorder,\r\n\r\n          -  Food allergies affecting diet\r\n\r\n          -  Substance abuse\r\n\r\n          -  Active medical conditions including diabetes and any cancer other than skin within 5\r\n             years\r\n\r\n          -  Serum creatinine > 110 umol/L, Hb < 110 g/L\r\n\r\n          -  Medications known to interfere with the metabolic endpoint measurements: diuretics,\r\n             beta-blockers, bronchodilators, non-steroidal anti-inflammatory drugs (NSAIDs),\r\n             antianginals, antiarrythmics and steroids (other than topical)\r\n\r\n          -  Disability\r\n      ","sponsor":"McGill University Health Centre/Research Institute of the McGill University Health Centre","sponsor_type":"Other","conditions":"Frail Elderly","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Leucine"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Alanine"}],"outcomes":[{"outcome_type":"primary","measure":"Change from Baseline in Fractional Synthesis Rate (FSR) at 12 weeks","time_frame":"Baseline and at 12 weeks"},{"outcome_type":"secondary","measure":"Change from Baseline in Physical Performance at 12 weeks","time_frame":"Baseline and at 12 weeks","description":"Short Physical Performance Battery test, Timed-up-and-Go test 6 Minute Walk Test\r\n1 repetition maximum Hand-grip strength"},{"outcome_type":"secondary","measure":"Change from Baseline in Body Composition at 12 weeks","time_frame":"Baseline and at 12 weeks","description":"Dual energy X-ray absorptiometry"},{"outcome_type":"secondary","measure":"Change from Baseline in Post-prandial responses at 12 weeks","time_frame":"Baseline and at 12 weeks","description":"Will measure excursion curves of glucose, insulin, branched chain amino acids, and amino acid profile"},{"outcome_type":"secondary","measure":"Change from Baseline in Fasting levels at 12 weeks","time_frame":"Baseline and at 12 weeks","description":"Will measure fasting levels of insulin growth factor-1 (IGF-1), interleukin-6 (IL-6), cortisol, as well as resting metabolic rate"},{"outcome_type":"other","measure":"Change from Baseline in Quality of Life at 12 weeks","time_frame":"Baseline and at 12 weeks","description":"EuroQuol EQ-5D-5L™"},{"outcome_type":"other","measure":"Change from Baseline in Mammalian target of rapamycin (mTOR) signalling proteins at 12 weeks","time_frame":"Baseline and at 12 weeks","description":"Quantity of the following proteins and their phosphorylation status:\r\nProtein kinase B (Akt) and phosphorylation on Ser473\r\nEukaryotic translation initiation factor 4E-binding protein 1 (4E-BP1) and phosphorylation on Thr37/46\r\nRibosomal protein S6 kinase beta-1 (S6K1) and phosphorylation on Thr389\r\nRibosomal protein S6 (rpS6) and phosphorylation on Ser240/244\r\nProline-rich Akt substrate of 40 kilodaltons (PRAS40) and phosphorylation on Thr246\r\nForkhead box O3a (FoxO3a) and phosphorylation on Thr32"}]}
{"nct_id":"NCT02285231","start_date":"2013-11-30","phase":"N/A","enrollment":60,"brief_title":"Anti-hyperglycemic Effect of Short-term Arginyl-fructose Supplementation in Subjects With Pre-diabetes and Newly Diagnosed Type 2 Diabetes: Randomized, Double-blinded, Placebo-controlled Trial.","primary_completion_date":"2014-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-05-31","last_update":"2014-11-06","description":"In this double-blind, placebo-controlled study, subjects with prediabetes and type 2 diabetes were randomly assigned to the placebo control group or the test (Arginyl-fructose: AF) group. We determined fasting serum levels of glucose, hemoglobin A1c (HbA1c), insulin, and free fatty acids (FFAs), were measured by 2-h oral glucose tolerance tests (OGTTs) at baseline and after the 6-week intervention.","other_id":"201406-BR-171-04","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        - All subjects are with prediabetes (IFG or IGT) or newly diagnosed type 2 DM (T2DM) no\r\n        taking medicine. IFG was defined as fasting glucose between 100 and 125 mg/dL and IGT was\r\n        defined as 2-h OGTTs glucose levels 140-199 mg/dL. Newly diagnosed type 2 diabetes was\r\n        defined as fasting glucose 126 mg/dL or 2-h OGTTs level  200 mg/dL.\r\n\r\n        Exclusion Criteria:\r\n\r\n        - Exclusion criteria included 1) glucose lowering medications or insulin injections; 2)\r\n        abnormal liver or renal function; 3) chronic stomach and intestines disease; 4) chronic\r\n        alcoholism; 5) pregnancy or intending to become pregnant during time of study. 6)\r\n        complications; 7) an occupation that could be dangerous if hypoglycemia should occur.\r\n      ","sponsor":"Yonsei University","sponsor_type":"Other","conditions":"Pre-diabetes","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Arginyl-fructose"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"2-h oral glucose tolerance tests (OGTTs","time_frame":"6 week"}]}
{"nct_id":"NCT02005601","start_date":"2013-11-30","phase":"Phase 4","enrollment":106,"brief_title":"Does Duloxetine Reduce Sub-Acute Pain After Knee Arthroplasty?","official_title":"Does Duloxetine Reduce Sub-Acute Pain After Knee Arthroplasty?","primary_completion_date":"2015-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-08-31","last_update":"2017-08-29","description":"We are investigating the impact of duloxetine (\"Cymbalta\"), a serotonin and norepinephrine reuptake inhibitor, on pain after total knee arthroplasty (TKA). Specifically, the investigators will determine whether duloxetine, 60 mg daily for 2 weeks, reduces pain scores 2 weeks after TKA.","other_id":"2012-016","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":25,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with osteoarthritis scheduled for primary tricompartmental total knee\r\n             arthroplasty with a participating surgeon\r\n\r\n          -  Age 25 to 75 years\r\n\r\n          -  Planned use of regional anesthesia\r\n\r\n          -  Ability to follow study protocol\r\n\r\n          -  English speaking (primary outcome obtained via telephone call and secondary outcomes\r\n             include questionnaires validated in English only)\r\n\r\n          -  Patients planning on being discharged home or to a rehabilitation center that has\r\n             agreed to participate\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Concurrent use of duloxetine or other SNRIs, MAOIs, Tricyclic antidepressants,\r\n             triptans (sumatriptan, rizatriptan, naratriptan, zolmitriptan, eletriptan,\r\n             almotriptan, frovatriptan), lithium, buspirone, St. John's Wort\r\n\r\n          -  Hepatic insufficiency\r\n\r\n          -  Renal insufficiency\r\n\r\n          -  Patients younger than 25 years old and older than 75\r\n\r\n          -  Patients intending to receive general anesthesia\r\n\r\n          -  Allergy or intolerance to one of the study medications\r\n\r\n          -  Patients with an ASA of IV\r\n\r\n          -  Chronic gabapentin/pregabalin use (regular use for longer than 3 months)\r\n\r\n          -  Chronic opioid use (taking opioids for longer than 3 months)\r\n\r\n          -  Patients with major prior ipsilateral open knee surgery\r\n      ","sponsor":"Hospital for Special Surgery, New York","sponsor_type":"Other","conditions":"Total Knee Arthroplasty","interventions":[{"intervention_type":"Drug","name":"Drug: Placebo","description":"Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."},{"intervention_type":"Drug","name":"Drug: Duloxetine 60mg","description":"Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."}],"outcomes":[{"outcome_type":"primary","measure":"NRS Pain With Ambulation at 2 Weeks","time_frame":"2 weeks after surgery","description":"When considering the pain in the knee in which you are having/had surgery, on a scale of 0-10, with 0 being no pain and 10 being pain as bad as you can imagine, how would you describe your level of pain in the last 24 hours during ambulation?"},{"outcome_type":"secondary","measure":"Total Daily Opioid Use (mg Oral Morphine Equivalents)","time_frame":"POD 1","description":"Total daily opioid use (including PO, PCEA, IV, subcutaneous, IV push) in mg oral morphine equivalents on POD 1."},{"outcome_type":"secondary","measure":"Nausea Severity","time_frame":"POD 1","description":"Nausea severity measured using Likert scale ranging from 0 (none) to 10 (severe)."}]}
{"nct_id":"NCT01983696","start_date":"2013-11-30","phase":"N/A","enrollment":100,"brief_title":"The Effect of Low Oxygen Tension on the Early Development of Human Embryo in IVF/ICSI","official_title":"The Effect of Low Oxygen Tension on the Early Development of Human Embryo in IVF/ICSI","primary_completion_date":"2014-03-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2014-10-31","last_update":"2013-11-27","description":"To investigate the effect of low oxygen tension during in vitro culture in terms of embryo quality and outcomes of pregnancy in vitro fertilization/ Intracytoplasmic sperm injection","other_id":"MCHC-2013-02","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Fresh cycles of in vitro fertilization/intracytoplasmic sperm injection and emrbyo\r\n             transfer (IVF/ICSI-ET)\r\n\r\n          -   10 oocytes after oocyte retrieval\r\n\r\n        Exclusion Criteria:\r\n\r\n          -   3 transfer or oocyte retrieval cycles\r\n\r\n          -  PGD/PGS cycles\r\n\r\n          -  half-ICSI/rescure ICSI\r\n\r\n          -  fluid in the uterine cavity, abnormal endometrium, uterine abnormalities,pelvic\r\n             inflammation\r\n\r\n          -  acute maternal problems.\r\n\r\n          -  One or both spouses have an abnormal karyotype (including polymorphism)\r\n      ","sponsor":"Shanxi Provincial Maternity and Children's Hospital","sponsor_type":"Other","conditions":"Embryo Hypoxia","interventions":[{"intervention_type":"Other","name":"Other: 5% oxygen concentration","description":"the oocytes and embryos are cultured in the incubator with concentrations of 6% CO2,5%O2, and 89% N2"}],"outcomes":[{"outcome_type":"primary","measure":"embryo quality","time_frame":"up to 6 days after fertilization","description":"Embryo morphology was assessed on day 2, day 3 day 4 day 5 day and 6 by considering the number of blastomeres, symmetry and granularity of blastomeres, type and percentage of fragmentation, presence of multinucleated blastomeres, and degree of compaction.\r\nGardner's blastocyst scoring system is used for blastocyst assessment"}]}
{"nct_id":"NCT02661581","start_date":"2013-11-30","phase":"N/A","enrollment":80,"brief_title":"Peer-led, Empowerment-based, Approach to Self-management Efforts in Diabetes","official_title":"Peer-led, Empowerment-based, Approach to Self-management Efforts in Diabetes: A Randomized Controlled Trial (The PLEASED Trial)","primary_completion_date":"2017-09-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2017-09-30","last_update":"2016-11-03","description":"PLEASED is a 12-month program that aims to help South Asians with type 2 diabetes improve and sustain diabetes-related health outcomes e.g. glycemic control, quality of life...) achieved from previous short-term diabetes education program. Our goal is to provide a new generation of education and support that can be ongoing, patient-driven, and flexible to the dynamic and evolving conditions of patients' \"real-word\" environment and life circumstances.","other_id":"H13-02163-A002","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":21,"population":"","criteria":"\n        To be eligible to participate as a subject in this study, individuals must\r\n\r\n          1. Have type 2 diabetes,\r\n\r\n          2. Be of South Asian background,\r\n\r\n          3. Live in the Metro Vancouver area,\r\n\r\n          4. Be at least 21 years old,\r\n\r\n          5. Have transportation to attend group sessions.\r\n\r\n        To be eligible to participate as a peer leader in this study, individuals must\r\n\r\n          1. Have diabetes or are a caregiver to someone who has diabetes,\r\n\r\n          2. Are of South Asian background,\r\n\r\n          3. Live in the Greater Vancouver area,\r\n\r\n          4. Are at least 21 years old,\r\n\r\n          5. Are bilingual in English and Punjabi,\r\n\r\n          6. Have transportation to attend training,\r\n\r\n          7. Are able and willing to commit to 6 sessions of training (5 hours each, over a 6 week\r\n             period)\r\n\r\n        Exclusion criteria for both participants and peer leaders include:\r\n\r\n          1. Serious health conditions\r\n\r\n          2. Addictions to alcohol or drugs, which would hinder meaningful participation in the\r\n             study.\r\n      ","sponsor":"University of British Columbia","sponsor_type":"Other","conditions":"Diabetes","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Peer Support","description":"The intervention is lifestyle change. First, the peer leaders will be trained how to conduct diabetes self-management education and support sessions. During the first 3 months, all the participants will attend the diabetes self-management education sessions. The participants in the intervention arm will also receive diabetes self-management support sessions as well. In the end of the first 3 months, the intervention group participants will receive weekly support sessions for 9 months."}],"outcomes":[{"outcome_type":"primary","measure":"Glycemic Control measured by HbA1c","time_frame":"Up to 12 months","description":"To compare a peer support model for diabetes self-management support (DSMS) to usual care on sustaining improvements in glycemic control achieved from short-term diabetes self-management education (DSME)."},{"outcome_type":"secondary","measure":"Blood pressure (mmHg) measured by Omron BP785 monitor","time_frame":"Up to 12 months"},{"outcome_type":"secondary","measure":"ApoB (g/L) will be collected using venous puncture blood draw","time_frame":"Up to 12 months"},{"outcome_type":"secondary","measure":"Waist circumference (inch) measured by Seca 203 Circumference Measuring Tape","time_frame":"Up to 12 months"},{"outcome_type":"secondary","measure":"Body Mass Index (kg/m2)","time_frame":"Up to 12 months"},{"outcome_type":"secondary","measure":"Physical activity measured by the actical accelerometer","time_frame":"Up to 12 months"},{"outcome_type":"secondary","measure":"Diabetes-specific Social Support will be assessed using a 4-item perceived social support scale developed by Tang et al. that measures amount of support and satisfaction with support from family, friends and the health care team","time_frame":"Up to 12 months"},{"outcome_type":"secondary","measure":"Depressive Symptom Severity will be assessed with the PRIME-MD Patient Health Questionnaire (PHQ-9)","time_frame":"Up to 12 months"},{"outcome_type":"secondary","measure":"Diabetes-related distress measured by the Diabetes Distress Scale (DDS), a 17-item scale developed by Polonsky and colleagues","time_frame":"Up to 12 months"},{"outcome_type":"secondary","measure":"Height measured using a stadiometer","time_frame":"Up to 12 months"},{"outcome_type":"secondary","measure":"Weight measured on a high quality, calibrated digital scale, with the participant wearing clothes, but no shoes","time_frame":"Up to 12 months"}]}
{"nct_id":"NCT01886222","start_date":"2013-11-12","phase":"N/A","enrollment":312,"brief_title":"Randomized Controlled Trial of Long-term Mild Hypothermia for Severe Traumatic Brain Injury","official_title":"A Multi-center, Randomized, Controlled Trial to Evaluate the Efficacy and Safety of Long-term Mild Hypothermia in Adult Patients With Severe Traumatic Brain Injury","primary_completion_date":"2019-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-06-30","last_update":"2020-03-12","description":"This study is a prospective multi-centre randomized trial to compare the effect of long-term mild hypothermia versus routine normothermic intensive management in patients with severe traumatic brain injury. The primary hypothesis is that the induction of mild hypothermia (maintained at 34-35) for 5 days will improve the outcome of patients at six months post injury compared with normothermia.","other_id":"RJNS001","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age 18 - 65 years within 6 hours post injury;\r\n\r\n          -  Closed head injury;\r\n\r\n          -  Glasgow Coma Scale(GCS) score 4 to 8 after resuscitation;\r\n\r\n          -  The intracranial pressure is more than 25 mmHg;\r\n\r\n          -  Cerebral contusion on computed tomographic scan.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  GCS of 3 with bilateral fixed and dilated pupils;\r\n\r\n          -  A life-threatening injury to an organ other than the brain;\r\n\r\n          -  No spontaneous breathing or cardiac arrest at the scene of the injury;\r\n\r\n          -  No consent;\r\n\r\n          -  Pregnancy.\r\n      ","sponsor":"RenJi Hospital","sponsor_type":"Other","conditions":"Brain Injuries|Craniocerebral Trauma","interventions":[{"intervention_type":"Other","name":"Other: Long-term mild hypothermia","description":"Hypothermia will be induced within 6 hours of injury and maintained at 34-35 for 5 days.Then the patients will be passively rewarmed to a temperature of 36 to 37C at a rate no greater than 0.5C/4 hours."},{"intervention_type":"Other","name":"Other: Normothermia","description":"Patients assigned to the normothermia group will be kept at 36-37."}],"outcomes":[{"outcome_type":"primary","measure":"Neurological function","time_frame":"6 months post injury","description":"The neurological function will be evaluated at 6 months post injury by a specialized investigator who is unaware of the patients' allocation according to five-category Glasgow Outcome Scale as follows: 1, death; 2, vegetative state - unable to interact with the environment; 3, severe disability - unable to live independently but able to follow commands; 4, moderate disability - capable of living independently but unable to return to work or school; and 5, good recovery - able to return to work or school."},{"outcome_type":"secondary","measure":"Intracranial pressure (ICP) control","time_frame":"Admission, day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, or until the monitor is removed","description":"The effect of long-term hypothermia on ICP control will be determined."},{"outcome_type":"secondary","measure":"Glasgow Coma Score (GCS)","time_frame":"Admission, day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, day 21, day 28 post injury","description":"The neurological function improvement during study intervention will be evaluated."},{"outcome_type":"secondary","measure":"Length of ICU stay","time_frame":"6 months post injury","description":"The numbers of days in the ICU."},{"outcome_type":"secondary","measure":"Length of hospital stay","time_frame":"6 months post injury","description":"The numbers of days in the hospital."},{"outcome_type":"secondary","measure":"Frequency of complications","time_frame":"6 months post injury","description":"Frequency of complications during the the study such as pneumonia, significant bleeding, liver and kidney function abnormality will be recorded and compared between groups."},{"outcome_type":"secondary","measure":"Mortality rate","time_frame":"6 months post injury","description":"The proportion of death will be determined at 6 months post injury."}]}
{"nct_id":"NCT01981343","start_date":"2013-11-11","phase":"Phase 2","enrollment":50,"brief_title":"A Parallel Study Evaluating the Effect of A-F Betafood on Gallbladder and Liver Function.","official_title":"A Randomized, Double Blind, Placebo Controlled Parallel Study Evaluating the Effect of A-F Betafood on Gallbladder and Liver Function.","primary_completion_date":"2018-02-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-03-31","last_update":"2018-04-11","description":"Gallstone formation is multifactorial: immutable risk factors include genetics and ethnicity, age and being female, and mutable risk factors include obesity, and metabolic syndrome, diet, rapid weight loss, and other conditions such as cirrhosis, Crohn's disease, irritable bowel syndrome, gallbladder stasis, and the use of certain drugs like Ceftriazone. Previous studies have linked serum cholesterol, and low-density lipoprotein cholesterol levels and fatty liver disease to gallbladder disease. Given betaine's reported beneficial effects on fatty liver and lipid profile, A-F Betafood may have a beneficial effect on gallbladder function. The objective of the study is to assess the effect of A-F Betafood on gallbladder and liver function as measured by gallbladder ultrasounds and liver function tests. The hypothesis is that A-F Betafood will improve gallbladder and liver function after the 12 week treatment period. This is a single-center, randomized, double-blind, placebo-controlled, parallel group study with two arms. This study will consist of a single 12 week treatment period. The planned sample size for this study is 50 overweight female subjects, with 25 subjects randomized equally to each of the two study arms in double-blind manner at a ratio of 1:1","other_id":"12AGHS","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Triple","sampling_method":"","gender":"Female","minimum_age":40,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Females 40-75 years of age or older not of child bearing potential. Defined as females\r\n             who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are\r\n             post-menopausal (natural or surgically with > 1 year since last menstruation).OR\r\n             Female subject of childbearing potential must agree to use a medically approved method\r\n             of birth control and have a negative urine pregnancy test result\r\n\r\n          -  BMI of 25.0 kg/m2 to 29.9 kg/m2\r\n\r\n          -  Agrees to comply with study procedures\r\n\r\n          -  Healthy as determined by laboratory results, medical history and physical exam\r\n\r\n          -  Has given voluntary, written, informed consent to participate in the study\r\n\r\n          -  Gastrointestinal distress with various fatty foods as determined by the modified GSRS\r\n             questionnaire\r\n\r\n          -  Family history of gallbladder disease or previous history of gallbladder attacks\r\n\r\n          -  Has a normal resting heart rate 50-80bpm\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Women who are pregnant, breastfeeding, or planning to become pregnant during the\r\n             course of the trial\r\n\r\n          -  Unstable psychiatric disorder requiring hospitalization within past 6 months\r\n\r\n          -  Use of prescription medications, over the counter medications or natural health\r\n             products/dietary supplements known to affect gastric/gastrointestinal function within\r\n             4 weeks of randomization\r\n\r\n          -  Presence of gallstones as determined by ultrasound\r\n\r\n          -  Uncontrolled hypertension defined as untreated systolic blood pressure > 160 mmHg\r\n             and/or diastolic blood pressure > 100 mmHg\r\n\r\n          -  Clinically significant abnormal laboratory results at screening including: AST, ALT\r\n             and/or bilirubin > 2 x the ULN; Serum creatinine >1.5 x the ULN or eGFR < 60;\r\n             Hemoglobin < 123 g/L\r\n\r\n          -  Participation in a clinical research trial within 30 days prior to randomization\r\n\r\n          -  Allergy or sensitivity to test article ingredients, soy, dairy, egg, wheat, peanut,\r\n             tree nuts, fish or shellfish.\r\n\r\n          -  Individuals who are cognitively impaired and/or who are unable to give informed\r\n             consent\r\n\r\n          -  Any other condition which in the Investigator's opinion may adversely affect the\r\n             subject's ability to complete the study or its measures or which may pose significant\r\n             risk to the subject\r\n      ","sponsor":"KGK Science Inc.","sponsor_type":"Industry","conditions":"Gallbladder","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: A-F Betafood"},{"intervention_type":"Other","name":"Other: Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"Gallbladder and Liver function","time_frame":"12 weeks","description":"Changes in Gallbladder Ultrasound and Liver function tests (fasting serum AST, ALT, GGT and hsCRP)"},{"outcome_type":"secondary","measure":"Gastrointestinal distress","time_frame":"12 weeks","description":"Modified GSRS questionnaire"},{"outcome_type":"secondary","measure":"Fasting Lipid Profile","time_frame":"12 weeks","description":"Changes in serum LDL-C, HDL-C, total cholesterol and triglycerides"},{"outcome_type":"secondary","measure":"Fasting Oxidized LDL","time_frame":"12 weeks","description":"Changes in serum oxidized LDL levels"},{"outcome_type":"secondary","measure":"Fasting TNF-alpha","time_frame":"12 weeks","description":"Changes in serum TNF-alpha levels"},{"outcome_type":"secondary","measure":"Fasting Adiponectin","time_frame":"12 weeks","description":"Changes in serum adiponectin levels"},{"outcome_type":"secondary","measure":"Blood Pressure","time_frame":"Over 12 weeks","description":"Changes in mean office blood pressure"},{"outcome_type":"secondary","measure":"Heart Rate","time_frame":"Over 12 weeks","description":"Changes in mean heart rate"},{"outcome_type":"secondary","measure":"Biometrics: weight and BMI","time_frame":"Over 12 weeks","description":"Changes in mean weight and BMI"},{"outcome_type":"secondary","measure":"Blood Safety Parameters","time_frame":"Over 12 weeks","description":"Changes in complete blood count, electrolytes (Na, K, Cl), creatinine, eGFR, AST, ALT,GGT, bilirubin"},{"outcome_type":"secondary","measure":"Fasting Malonyldialdehyde","time_frame":"12 weeks","description":"Changes in serum malonyldialdehyde (MDA) levels"},{"outcome_type":"secondary","measure":"Adverse events","time_frame":"Over 12 weeks","description":"Record and monitor any adverse events"}]}
{"nct_id":"NCT01946646","start_date":"2013-10-31","phase":"Phase 1","enrollment":10,"brief_title":"Phase I Study of TS-1 With Concurrent Radiotherapy to Treat Pancreatic Cancer","official_title":"A Phase I Study of TS-1 With Concurrent Radiotherapy Followed by Gemcitabine and TS-1 in Metastatic Pancreatic Cancer (SR-GS Study)","primary_completion_date":"2017-01-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2017-01-31","last_update":"2017-01-18","description":"The purpose of this study is to determine whether combination of TS-1 and concurrent and short-course radiotherapy is feasible in metastatic pancreatic cancer. The rationale of this study primarily bases on the good efficacy of gemcitabine plus TS-1 and the great potential of local control of concurrent chemoradiotherapy in pancreatic cancer.","other_id":"201211048MPC","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":79,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  histologically or cytologically proven, newly diagnosed pancreatic adenocarcinoma or\r\n             adenosquamous carcinoma\r\n\r\n          -  no previous radiotherapy, chemotherapy, targeted therapy, curative surgery, or\r\n             immunotherapy used for pancreatic cancer\r\n\r\n          -  presence of at least one measurable lesion, which must meet the criteria of being  20\r\n             mm in at least one dimension by conventional CT/MRI or  10 mm by spiral CT scan\r\n\r\n          -  age between 20 and 79 years at registration\r\n\r\n          -  ECOG PS of 0 or 1\r\n\r\n          -  adequate major organ functions\r\n\r\n          -  ability to take the oral study medication (TS-1)\r\n\r\n          -  no clinically significant abnormal ECG findings within 28 days (4 weeks) prior to\r\n             registration\r\n\r\n          -  voluntarily signed the written informed consent form\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  pulmonary fibrosis or interstitial pneumonitis diagnosed within 28 days prior to\r\n             registration\r\n\r\n          -  presence of diarrhea  CTCAE v.4.03 grade 2\r\n\r\n          -  concomitant active infection or significant co-morbid medical conditions\r\n\r\n          -  moderate or severe ascites or pleural effusion that requires drainage\r\n\r\n          -  central nervous system metastasis\r\n\r\n          -  prior or concurrent malignancies within the last 3 years\r\n\r\n          -  concomitant treatment with flucytosine, phenytoin or warfarin\r\n\r\n          -  pregnant women or nursing mothers, or positive pregnancy test\r\n\r\n          -  severe mental disorder\r\n\r\n          -  judged ineligible by physician for participation in the study due to safety concern\r\n      ","sponsor":"National Taiwan University Hospital","sponsor_type":"Other","conditions":"Metastatic Pancreatic Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: S-1-CCRT"}],"outcomes":[{"outcome_type":"primary","measure":"maximum tolerated dose","time_frame":"6 weeks","description":"Dose-limiting toxicities (DLT) are defined as the following manifestations of toxicity observed until completion of CCRT:\r\ngrade 3 leucopenia and/or neutropenia with a fever ≥ 38°C lasting 3 days or more\r\ngrade 3 leucopenia and/or neutropenia with infection\r\ngrade 4 leucopenia and/or neutropenia lasting 3 days or more\r\ngrade 4 leucopenia and/or neutropenia requiring G-CSF\r\nplatelet < 25,000/mm3\r\n, grade 3 thrombocytopenia requiring transfusion\r\nhemoglobin < 8.0 g/dL\r\ng. serum AST/ALT ≥ 10 times ULN h. total bilirubin ≥ 3 times ULN i. creatinine >3.0 - 6.0 times ULN (grade 3) i. grade 3 or 4 nonhematological toxicities including nausea, vomiting, anorexia, fatigue, constipation, hyperglycemia, and abnormality of sodium, potassium, and calcium If three or more patients experience DLT at a given dose level, then the previous dose level will be considered as the MTD."},{"outcome_type":"primary","measure":"maximum-tolerated dose","time_frame":"6 weeks"}]}
{"nct_id":"NCT01972672","start_date":"2013-10-31","phase":"Phase 2","enrollment":70,"brief_title":"The Phase II Study of Icaritin in Patients With Advanced Hepatocellular Carcinoma","official_title":"An Open-label,Single-arm Phase II Study of Icaritin in Patients With Advanced Hepatocellular Carcinoma","primary_completion_date":"2015-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-03-31","last_update":"2021-01-27","description":"The primary objective of the study is to assess the time to progression (TTP) in patients with advanced HCC treated with Icaritin .","other_id":"QU1305ICR","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Patients may be entered in the study only if they meet all of the following criteria:\r\n\r\n          1. The age is between 18 and 75.\r\n\r\n          2. Patients who have HCC which should be histologically or cytologically confirmed. At\r\n             least one lesion, not previously treated ( can be accurately measured at baseline as \r\n             10 mm in the longest diameter with computed tomography (CT) per RECIST 1.1)\r\n\r\n          3. Patients who cannot accept or is not willing to have surgery or any interventional\r\n             therapy via hepatic artery, or had surgery and any Interventional therapy via hepatic\r\n             artery more than 4 weeks with disease progression, and cannot tolerate Sorafenib or\r\n             Oxaliplatin doublet chemotherapy or cannot use or refused to use them\r\n\r\n          4. Child-Pugh status A or B (7) ( Either albumin or haemachrome is >2)\r\n\r\n          5. ECOG PS: 0 or 1.\r\n\r\n          6. Patients who have a life expectancy of at least 12 weeks.\r\n\r\n          7. Patients who have not received chemotherapy and target therapy. If patients received\r\n             radiation therapy or surgery, the treatment should be at least 4 weeks prior to\r\n             enrollment and any AE and wounds during the treatment should be recovered. If patient\r\n             received adjuvant chemotherapy, the treatment should be at least 6 months prior to\r\n             enrollment.\r\n\r\n          8. Meet following laboratory parameters:\r\n\r\n               -  Haematology ( no blood transfusion or Blood products or Hematopoietic growth\r\n                  factor within 14 days)\r\n\r\n                    1. Hemoglobin  90 g/dL\r\n\r\n                    2. Neutrophil cell count1.5  10^9/L\r\n\r\n                    3. Platelet count  80  10^9/L\r\n\r\n               -  Clinical chemistry,\r\n\r\n                    1. Albumin  29 g/dL (no albumin transfusion or blood product within 14 days)\r\n\r\n                    2. ALT and AST < 5  ULN\r\n\r\n                    3. Total bilirubin  1.5  ULN\r\n\r\n                    4. Serum creatinine  1.5  ULN\r\n\r\n          9. If HBV-DNA10^4, anti-virus therapy should be used until HBV-DNA< 10^4\r\n\r\n         10. Patients is willing to participate in the study with good compliance and must have\r\n             given written informed consent prior to any study specific screening\r\n\r\n         11. Patients who did not participate in any other study 4 weeks prior to enrollment and\r\n             all adverse events occurs before should be recovered.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Patients who meet with any below criterion should not be included in the study:\r\n\r\n          1. Previously known intrahepatic cholangiocarcinoma, mixed cell carcinoma and\r\n             fibrolamellar carcinoma; previous or concurrent malignant tumor (healed skin basal\r\n             cell carcinoma and carcinoma in situ of uterine cervix are not included);\r\n\r\n          2. Women in pregnancy or lactation;\r\n\r\n          3. Patients who have hypertension and blood pressure are not well controlled after\r\n             treatments with antihypertensive drugs (systolic pressure > 150mmHg, diastolic\r\n             pressure >100mmHg); patients who have grade II or higher myocardial ischemia or\r\n             myocardial infarction and poorly controlled arrhythmia (including QTC interval 450ms)\r\n             and grade III-IV cardiac insufficiency according to NYHA criteria; Ultrasound\r\n             Cardiogram on heart: LVEF (left ventricular ejection fraction)<50%;\r\n\r\n          4. Patients are incapable of swallow, or have chronic diarrhea or intestinal obstruction,\r\n             which significantly affects administration and absorption of study drug;\r\n\r\n          5. Patients potentially have gastrointestinal hemorrhage (such as local active ulcer\r\n             foci, occult blood in stools ++ or even higher), previous medical records of\r\n             alimentary tract hemorrhage within six months;\r\n\r\n          6. Patients who have central nervous system metastasis;\r\n\r\n          7. Patients who have coagulation disorder (prothrombin time > 16s, activated partial\r\n             thromboplastin time > 43s, thrombin time >21s, fibrinogen< 2g/L), subjects showing\r\n             hemorrhagic tendency or accepting thrombolytic or anticoagulant therapy;\r\n\r\n          8. Patients who have psychiatric disorders or previous medical history of psychotropic\r\n             drug abuse;\r\n\r\n          9. Patients who have seroperitoneum with clinical symptoms, requring remedial abdominal\r\n             paracentesis or drainage, or Child-Pugh score 2.\r\n      ","sponsor":"Beijing Shenogen Biomedical Co., Ltd","sponsor_type":"Industry","conditions":"Hepatocellular Carcinoma (HCC)","interventions":[{"intervention_type":"Drug","name":"Drug: Icaritin","description":"Icaritin 600 mg orally, twice daily for a total daily dose of 1200 mg"}],"outcomes":[{"outcome_type":"primary","measure":"time to progress（TTP）","time_frame":"1-2 years","description":"The study will be an open-label, single-armed study to evaluate the clinical benefit of Icaritin 600 mg twice daily with oral administration for total of 1200 mg daily added to Best Supportive Care in patients with advanced HCC."},{"outcome_type":"secondary","measure":"Progression-free survival (PFS)","time_frame":"1-2 years","description":"PFS is defined as the time from the date of the first dose of study drug to first documentation of objective disease progression or to death on study due to any cause, whichever occurs first. It will be analyzed in the same way as TTP."},{"outcome_type":"secondary","measure":"Overall survival (OS)","time_frame":"1-2 years","description":"OS: This is defined as the time from the date of first study dose to the date of death, regardless of the cause of death. Patients who were alive at the time of the analysis will be censored at the date of the last follow up assessment. Patients without follow up assessment will be censored at the day of last dose and patients with no post baseline information will be censored at the time of first study dose. Overall survival is defined as the length of time from first dose of treatment until death. It will be analyzed in the same way as TTP."},{"outcome_type":"secondary","measure":"Overall response rate (ORR) (proportion of patients with confirmed partial and complete responses)","time_frame":"1-2 years","description":"ORR: it is defined as the percentage of the patients achieving remission (including PR and CR) of tumors during treatment or within 30 days after the initiative treatment as confirmed by the RECIST1.1."},{"outcome_type":"secondary","measure":"Overall disease control rate (DCR)","time_frame":"1-2 years","description":"DCR: during first-line therapy is defined as SD for 8 weeks or longer, CR plus PR as determined by the RESIST 1.1 criteria for patients with measurable disease.\r\nObjective response rate and disease control rate will be determined along with 95% confidence intervals."},{"outcome_type":"secondary","measure":"Assessment on Quality of life","time_frame":"1-2 years","description":"The descriptive analysis will be used for the data from quality of life questionnaire (EORTC QLQ-C30 V3.0 and HCC-18)."},{"outcome_type":"secondary","measure":"Type, incidence, severity, seriousness and relationship to study drug of adverse events (AEs) and serious adverse events (SAEs);","time_frame":"1-2 years","description":"To assess the safety and tolerability of Icaritin in patients with advanced hepatocellular carcinoma"},{"outcome_type":"secondary","measure":"Laboratory abnormal findings","time_frame":"1-2 years","description":"To assess the safety and tolerability of Icaritin in patients with advanced hepatocellular carcinoma"},{"outcome_type":"other","measure":"p-STAT3 and ER-α36 expression","time_frame":"1-2 years","description":"Explore endpoints"},{"outcome_type":"other","measure":"Blood biomarkers of estradiol (E2), hepatocyte growth factor (HGF), interleukin-6 (IL-6), transforming growth factor β (TGF-β), and alpha-fetoprotein (AFP);","time_frame":"1-2 years","description":"Explore endpoints"},{"outcome_type":"other","measure":"Gene expression profiling of blood cells and tumor biopsies","time_frame":"1-2 years","description":"Explore endpoints"}]}
{"nct_id":"NCT01963182","start_date":"2013-10-31","phase":"Phase 2","enrollment":47,"brief_title":"Individualization of Dosage of Irinotecan in the FOLFIRI According to the Genetic Polymorphism of UGT1A1 in the First Line Treatment of Metastatic Colorectal Cancer","official_title":"Phase II Study: Individualization of Dosage of Irinotecan in the FOLFIRI According to the Genetic Polymorphism of UGT1A1 in the First Line Treatment of Metastatic Colorectal Cancer","primary_completion_date":"2019-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-12-09","last_update":"2019-12-26","description":"This prospective, non randomized multicenter phase II study, will determine the feasibility of individualized dose of irinotecan with the UGT1A1 polymorphism, in patients with metastatic colorectal cancer treated with FOLFIRI.","other_id":"2013-001275-21","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Colorectal cancer histologically or cytologically proven\r\n\r\n          -  Indication of treatment according to the FOLFIRI + / - bevacizumab or cetuximab or\r\n             panitumumab\r\n\r\n          -  Age> 18 years\r\n\r\n          -  Presence of at least one measurable target by RECIST\r\n\r\n          -  Life expectancy> 3 months\r\n\r\n          -  Satisfactory biological functions (renal, hepatic and hematologic)\r\n\r\n          -  Affiliation to a social security scheme (or be the beneficiary of such a plan) under\r\n             the terms of the Act of August 9, 2004\r\n\r\n          -  Patient has signed, after informing the informed consent form\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients of childbearing age and not using effective contraception during treatment\r\n             and for at least three months after the end of treatment with irinotecan and at least\r\n             six months after the end of treatment with bevacizumab, cetuximab or panitumumab and\r\n             patient pregnant or nursing\r\n\r\n          -  Patient with another pathology deemed incompatible with the entry in the protocol\r\n\r\n          -  Prior treatment in metastatic\r\n\r\n          -  Patients taking antiepileptic\r\n\r\n          -  Allergic reaction or intolerance to irinotecan\r\n\r\n          -  Heart failure , kidney , bone marrow , liver or respiratory\r\n\r\n          -  Higher bilirubin 1.5 times the upper limit of normal\r\n\r\n          -  Significant psychiatric or neurological abnormality\r\n\r\n          -  Infectious syndrome requiring treatment with antibiotics or antiviral long-term\r\n\r\n          -  Patients with chronic inflammatory bowel disease and / or bowel obstruction\r\n\r\n          -  Contraindication Association St. John's wort and yellow fever vaccine\r\n\r\n          -  Against Heart indication 5-FU\r\n\r\n          -  Concurrent treatment with a drug test , participation in a clinical trial within <30\r\n             days\r\n\r\n          -  Patient refused to sign the consent\r\n      ","sponsor":"Centre Jean Perrin","sponsor_type":"Other","conditions":"First Line Metastatic Colorectal Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Irinotecan"}],"outcomes":[{"outcome_type":"primary","measure":"severe toxicity (according to NCI-CTC cotation) and response with adapted dose of irinotecan","time_frame":"during the treatment (an expected average of 7 months)"},{"outcome_type":"secondary","measure":"Study of the blood concentration (pharmacokinetic) of irinotecan, the SN38 and SN38-G, and bevacizumab","time_frame":"during the first 24 hours of the first cure"},{"outcome_type":"secondary","measure":"evaluation of treatment efficacy (progression-free survival, duration of response)","time_frame":"to progression (1 year)"}]}
{"nct_id":"NCT01923194","start_date":"2013-10-31","phase":"Phase 3","enrollment":215,"brief_title":"Evaluation of Efficacy and Safety of Highly Purified Urofollitropin for Ovulation Induction in Chinese Females","official_title":"A Randomized, Assessor-blinded, Parallel Group, Multi-center, Non-inferiority Study Investigating the Efficacy and Safety of Highly Purified Urofollitropin for Injection Compared to Recombinant Human Follitropin Alfa for Injection for Ovulation Induction Using a Low-dose, Step-up Protocol in Chinese Females With WHO Group II Anovulatory Infertility Failing to Conceive on Clomiphene Citrate","primary_completion_date":"2015-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-08-31","last_update":"2015-08-21","description":"Evaluate the Efficacy and Safety of Highly Purified Urofollitropin for Injection Compared to Recombinant Human Follitropin Alfa for Injection for Ovulation Induction in Chinese females","other_id":"000055","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"Female","minimum_age":20,"maximum_age":39,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Signed informed consent form prior to screening evaluations\r\n\r\n          -  Chinese females between the ages of 20-39 years\r\n\r\n          -  Infertility for at least 1 year before screening\r\n\r\n          -  Women WHO type II anovulatory infertility with chronic anovulation (defined as\r\n             amenorrhoea (i.e., no menstrual bleeding for 6 months or more) or oligoamenorrhoea\r\n             (i.e., cycles of more than 35 days) ) with progestogen induced withdrawal bleeding or\r\n             spontaneous menstrual bleeding\r\n\r\n          -  Failure to conceive after at least one cycle of ovulation induction with clomiphene\r\n             citrate\r\n\r\n          -  Bilateral tubal patency documented by a hysterosalpingography or sonohysterography or\r\n             laparoscopy within 2 years prior to screening\r\n\r\n          -  Normal pelvis documented by a transvaginal ultrasound with respect to uterus,\r\n             Fallopian tubes and ovaries within 3 months prior to screening\r\n\r\n          -  Early follicular phase serum levels of FSH within normal limits (1-12 IU/L,) (results\r\n             obtained within 2 months prior to randomization)\r\n\r\n          -  LH (Luteinizing hormone), prolactin , E2 (estradiol), progesteron, total testosterone,\r\n             and TSH (thyrotropin) levels within normal limits for the clinical laboratory\r\n\r\n          -  Male partner with a semen analysis obtained within 12 months prior to randomisation\r\n             and showing acceptable values for semen according to the local laboratory, or showing\r\n             more than 2.000.000 progressive motile sperm per mL after capacitation (in case of IUI\r\n             (intrauterine insemination))\r\n\r\n          -  BMI (Body mass index) is  18.5 and < 30 kg/m2\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any known clinically significant systemic disease\r\n\r\n          -  Known past or current thrombophlebitis or thromboembolism including venous thrombosis\r\n             disease and active or recent arterial thrombosis disease\r\n\r\n          -  Any known endocrine or metabolic abnormalities which can compromise participation in\r\n             the trial with the exception of controlled thyroid function disease\r\n\r\n          -  Any known concomitant medications that would interfere with evaluation of study\r\n             medications. Specifically, any non-study hormonal therapy (except for thyroid\r\n             medication), anti-psychotics, anxiolytics, hypnotics and sedatives, and need for\r\n             continuous use of prostaglandin inhibitors (non-steroid anti- inflammatory drugs\r\n             (NSAIDs), including aspirin) at the time of study entry.\r\n\r\n          -  Known history of 12 or more unsuccessful (no pregnancy achieved) ovulation induction\r\n             cycles\r\n\r\n          -  Any known treatment with clomiphene citrate, metformin, gonadotropins or GnRH\r\n             analogues within one month prior to randomisation\r\n\r\n          -  Ovarian cysts with a mean diameter  15 mm that have persisted for more than one cycle\r\n             or ovarian endometrioma on ultrasound\r\n\r\n          -  Known at least one previous cycle experienced luteinized unruptured follicle syndrome\r\n\r\n          -  Known abnormal results of cervical examination of clinical significance obtained\r\n             within 1 years prior to screening\r\n\r\n          -  Abnormal vaginal bleeding of undetermined origin\r\n\r\n          -  Known tumors of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus\r\n\r\n          -  Known malformations of the sexual organs incompatible with pregnancy\r\n\r\n          -  Known current or past (last 12 months) abuse of alcohol or drugs\r\n\r\n          -  Known history of chemotherapy (except for gestational conditions) or radiotherapy\r\n\r\n          -  Finding of any clinically relevant abnormal laboratory value\r\n\r\n          -  Use of any non registered investigational drugs during 3 months before screening or\r\n             previous participation in the study\r\n\r\n          -  Pregnancy, lactation or contraindication to pregnancy\r\n      ","sponsor":"Ferring Pharmaceuticals","sponsor_type":"Industry","conditions":"Anovulation","interventions":[{"intervention_type":"Drug","name":"Drug: Highly Purified Urofollitropin","description":"for Injection"},{"intervention_type":"Drug","name":"Drug: Recombinant Human Follitropin Alfa","description":"for Injection"}],"outcomes":[{"outcome_type":"primary","measure":"The ovulation rate defined as the percentage of subjects who present ovulation","time_frame":"From 6 days up to 7 weeks post hCG (human chorionic gonadotropin) administration"},{"outcome_type":"secondary","measure":"The positive serum progesterone rate","time_frame":"6~9 days post hCG administration"},{"outcome_type":"secondary","measure":"The positive serum β-hCG/hCG rate","time_frame":"18~22 days post hCG administration"},{"outcome_type":"secondary","measure":"The clinical pregnancy rate","time_frame":"6~7 weeks post hCG administration","description":"Regardless of fetal heart beat"},{"outcome_type":"secondary","measure":"The clinical pregnancy rate","time_frame":"6~7 weeks post hCG administration","description":"With fetal heart beat"},{"outcome_type":"secondary","measure":"The ongoing pregnancy rate","time_frame":"11~12 weeks post hCG administration"},{"outcome_type":"secondary","measure":"The follicular development","time_frame":"On the day of hCG administration"},{"outcome_type":"secondary","measure":"Endometrial thickness","time_frame":"On the day of hCG administration"},{"outcome_type":"secondary","measure":"Total FSH (Follicle-stimulating hormone) dose administered","time_frame":"On the day of hCG administration"},{"outcome_type":"secondary","measure":"Number of FSH treatment days","time_frame":"On the day of hCG administration"},{"outcome_type":"secondary","measure":"Frequency and severity of adverse events","time_frame":"Expected maximum of 6 months"},{"outcome_type":"secondary","measure":"Frequency and severity of injection site reactions","time_frame":"Day 1 up to Day 28 of the ovarian stimulation period"},{"outcome_type":"secondary","measure":"Serum estradiol (E2) levels","time_frame":"On the day of hCG administration"}]}
{"nct_id":"NCT01958606","start_date":"2013-10-31","phase":"N/A","enrollment":18,"brief_title":"High Intensity Interval Training in Chronic Stroke","official_title":"High Intensity Interval Training in Chronic Stroke","primary_completion_date":"2014-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-08-31","last_update":"2017-05-15","description":"The objective of this study was to compare the effectiveness of high intensity interval training (HIT) and traditional aerobic training for persons with stroke.","other_id":"HIT in chronic stroke","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":35,"maximum_age":90,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  1) age 35-90 years\r\n\r\n          -  2) unilateral stroke experienced >6 months prior to enrollment\r\n\r\n          -  3) able to walk 10m overground with assistive devices as needed and no physical\r\n             assistance\r\n\r\n          -  4) able to walk 3 minutes on the treadmill at >.13m/s (0.3mph) with no aerobic\r\n             exercise contraindications\r\n\r\n          -  5) stable cardiovascular condition (American Heart Association class B, allowing for\r\n             aerobic capacity <6 metabolic equivalents)\r\n\r\n          -  6) discharged from formal rehabilitation\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  1) significant resting ECG abnormalities\r\n\r\n          -  2) evidence of significant arrhythmia or myocardial ischemia on treadmill ECG stress\r\n             test\r\n\r\n          -  3) hospitalization for cardiac or pulmonary disease within 3 months\r\n\r\n          -  4) pacemaker or implanted defibrillator\r\n\r\n          -  5) lower extremity claudication\r\n\r\n          -  6) unable to communicate with investigators or correctly answer consent comprehension\r\n             questions\r\n\r\n          -  7) severe lower extremity spasticity (Ashworth >2)\r\n\r\n          -  8) lower extremity weight bearing pain >4/10 on visual analogue scale\r\n\r\n        For the transcranial magnetic stimulation substudy, additional exclusions will also be\r\n        applied. These include large cerebral infarcts or other structural defects with the\r\n        potential to increase seizure risk, uncontrolled seizures, metal implants and previous\r\n        craniotomy.\r\n      ","sponsor":"University of Cincinnati","sponsor_type":"Other","conditions":"Stroke","interventions":[{"intervention_type":"Other","name":"Other: High-intensity interval training (HIT)","description":"Treadmill exercise using bursts of concentrated effort alternated with recovery periods"},{"intervention_type":"Other","name":"Other: Traditional Aerobic Training","description":"Moderate intensity continuous aerobic exercise on a treadmill"}],"outcomes":[{"outcome_type":"other","measure":"Change in Transcranial Magnetic Stimulation (TMS) Responses From Baseline to 4 Weeks","time_frame":"Baseline and 4 weeks","description":"Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency, corticomotor map size and volume and intracortical inhibition"},{"outcome_type":"primary","measure":"Change in Peak Aerobic Capacity (VO2-peak)","time_frame":"Baseline and 4 weeks"},{"outcome_type":"secondary","measure":"Change in Submaximal Aerobic Capacity (VO2 at Ventilatory Threshold)","time_frame":"Baseline and 4 weeks"},{"outcome_type":"secondary","measure":"Change in Gait Velocity (10 Meter Walk Test)","time_frame":"Baseline and 4 weeks"},{"outcome_type":"secondary","measure":"Change in 6-Minute Walk Test","time_frame":"Baseline and 4 weeks","description":"distance walked in 6 minutes"},{"outcome_type":"secondary","measure":"Change in Gait Economy (Mean Oxygen Uptake at Comfortable Walking Speed)","time_frame":"Baseline and 4 weeks","description":"mean oxygen uptake at comfortable walking speed reported in units mLO2 per kilogram body weight per meter"},{"outcome_type":"secondary","measure":"Change in Fastest Treadmill Speed (Steep Ramp Test)","time_frame":"Baseline and 4 weeks","description":"fastest safe treadmill walking speed"},{"outcome_type":"secondary","measure":"Change in Fractional Utilization","time_frame":"Baseline and 4 weeks","description":"Metabolic cost of gait as a percentage of aerobic capacity"},{"outcome_type":"other","measure":"Change in Self-Efficacy and Outcome Expectations for Exercise Scale","time_frame":"Baseline and 4 weeks"},{"outcome_type":"other","measure":"Change in Montreal Cognitive Assessment","time_frame":"Baseline and 4 weeks"},{"outcome_type":"other","measure":"Change in Gait Kinematics/Kinetics From Baseline to 4 Weeks","time_frame":"Baseline and 4 weeks","description":"3D motion capture and force plates"},{"outcome_type":"other","measure":"Change in Gait Kinematics/Kinetics From Baseline to Post Session 1","time_frame":"Baseline and after session 1","description":"3D motion capture and force plates"},{"outcome_type":"other","measure":"Change in Gait Kinematics/Kinetics During Session 1","time_frame":"During session 1","description":"3D motion capture and force plates"},{"outcome_type":"other","measure":"Change in Transcranial Magnetic Stimulation (TMS) Responses Associated With Training Session 2","time_frame":"Before and after training session 2","description":"Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency and intracortical inhibition"},{"outcome_type":"other","measure":"Change in Transcranial Magnetic Stimulation (TMS) Responses Associated With Training Session 12","time_frame":"Before and after training session 12","description":"Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency and intracortical inhibition"},{"outcome_type":"other","measure":"Change in Daily Physical Activity (Activity Monitor)","time_frame":"Baseline and 4 weeks"},{"outcome_type":"other","measure":"Change in Stroke Impact Scale","time_frame":"Baseline and 4 weeks","description":"Cognition Domain Score of Stroke Impact Scale. Scores range from 0 to 100 (higher is better) and represent a sum of scores from multiple questions related to cognition."}]}
{"nct_id":"NCT02055274","start_date":"2013-10-31","phase":"Phase 1","enrollment":39,"brief_title":"Pharmacokinetics and Safety Study of LY03003 in Patients With Early-stage Parkinson's Disease","official_title":"A Randomized, Double-blinded, Multiple Ascending Dose Study in Patients With Early-stage Parkinson's Disease to Evaluate the Pharmacokinetics and Safety of LY03003 Following Intramuscular Injections","primary_completion_date":"2015-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-08-31","last_update":"2015-10-21","description":"The purpose of this study is to characterize the pharmacokinetics (PK) of LY03003 following multiple escalating intramuscular injections, as compared to Neupro patch and to evaluate the safety and tolerability and preliminary efficacy of multiple ascending dose (MAD) of LY03003 following intramuscular injections.","other_id":"LY03003","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Subject has Idiopathic Parkinson's Disease defined by the cardinal sign, Bradykinesia,\r\n             plus the presence of at least 1 of the following: resting tremor, rigidity, or\r\n             impairment of postural reflexes, and without any other known or suspected cause of\r\n             Parkinsonism\r\n\r\n          2. Subject is Hoehn & Yahr stage 3\r\n\r\n          3. Subject is male or female aged 18 years at Screening\r\n\r\n          4. Subject has a Mini Mental State Examination (MMSE) score of 25\r\n\r\n          5. Subject has a Unified Parkinson's Disease Rating Scale (UPDRS) motor score (Part III)\r\n             of 10 but 30 at Screening\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Subject has atypical Parkinson's syndrome(s) due to drugs (e.g., Metoclopramide,\r\n             Flunarizine), metabolic neurogenetic disorders (e.g., Wilson's Disease), Encephalitis,\r\n             Cerebrovascular Disease, or Degenerative Disease (e.g., progressive Supranuclear\r\n             Palsy)\r\n\r\n          2. Subject has a history of Pallidotomy, Thalamotomy, deep brain stimulation, or fetal\r\n             tissue transplant\r\n\r\n          3. Subject has dementia, active psychosis or hallucinations, or clinically significant\r\n             depression\r\n\r\n          4. Subject has a lifetime history of suicide attempt (including an active attempt,\r\n             interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6\r\n             months as indicated by a positive response (\"Yes\") to either Question 4 or Question 5\r\n             of the Columbia-Suicide Severity Rating Scale (CSSRS) at Screening\r\n\r\n          5. Subject has a history of symptomatic orthostatic hypotension with a decrease of 20\r\n             mmHg in systolic blood pressure (SBP) or 10 mmHg in diastolic blood pressure when\r\n             changing from supine to standing position after having been at supine position for at\r\n             least 5 minutes within 28 days prior to the Screening Visit, or SBP less than 105 mmHg\r\n             at study entry, or reports clinical signs of clinically significant orthostatic\r\n             hypotension within 28 days prior to the Screening Visit.\r\n\r\n          6. Subject is receiving therapy with a dopamine agonist (DA) either concurrently or has\r\n             done so within 28 days prior to the Screening\r\n\r\n          7. Subject is receiving therapy with 1 of the following drugs either concurrently or\r\n             within 28 days prior to screening: MAO-B inhibitors, DA releasing agents, DA\r\n             modulating agent, DA antagonists, neuroleptics, or other medications that may interact\r\n             with DA function.\r\n\r\n          8. Subject is currently receiving central nervous system active therapy (e.g., sedatives,\r\n             hypnotics, antidepressants, anxiolytics), unless the dose has been stable for at least\r\n             28 days prior to Screening Visit and is likely to remain stable for the duration of\r\n             the study. Patients should not take those medications within 8 hours prior to clinical\r\n             visits\r\n\r\n          9. Subject has a current diagnosis of epilepsy, has a history of seizures as an adult,\r\n             has a history of stroke, or has had a transient ischemic attack within 1 year prior to\r\n             Screening\r\n\r\n         10. Subject has a history of known intolerance/hypersensitivity to non-dopaminergic\r\n             antiemetics, such as domperidone, ondansetron, tropisetron, and glycopyrrolate\r\n\r\n         11. Subject has any other clinically relevant hepatic, renal and cardiac dysfunction, or\r\n             other medical condition or laboratory abnormality including abnormal plasma magnesium\r\n             level, which would in the judgment of the investigator, interfere with the subject's\r\n             ability to participate in the study\r\n\r\n         12. Subject has a history of significant skin hypersensitivity to adhesive or other\r\n             transdermal preparations or recent unresolved contact Dermatitis (this item is\r\n             specific for patients to be enrolled to part 2 of this study)\r\n\r\n         13. Subjects with C-reactive protein levels of 2x of upper limit of normal range\r\n\r\n         14. Female subjects who are pregnant or are breastfeeding or are of childbearing potential\r\n             without adequate contraception.\r\n\r\n         15. Patients with a positive finding in drug screening test or alcohol test\r\n      ","sponsor":"Luye Pharma Group Ltd.","sponsor_type":"Industry","conditions":"Parkinson's Disease","interventions":[{"intervention_type":"Drug","name":"Drug: Neupro"},{"intervention_type":"Drug","name":"Drug: LY03003"}],"outcomes":[{"outcome_type":"primary","measure":"Cmax for the Pharmacokinetics (PK) of LY03003","time_frame":"5 Weeks"},{"outcome_type":"secondary","measure":"Number of Participants with Adverse Events as a Measure of Safety and Tolerability","time_frame":"5 Weeks"},{"outcome_type":"secondary","measure":"Preliminary efficacy evaluation will be carried out based on Unified Parkinson's Disease Rating Scale (UPDRS) motor score (Part III)","time_frame":"5 Weeks"}]}
{"nct_id":"NCT01948596","start_date":"2013-10-31","phase":"Phase 2","enrollment":13,"brief_title":"The Synchronized Trial on Expectant Mothers With Depressive Symptoms by Omega-3 PUFAs (SYNCHRO): Open Trial","official_title":"The Synchronized Trial on Expectant Mothers With Depressive Symptoms by Omega-3 PUFAs (SYNCHRO) : Open Trial","primary_completion_date":"2015-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-05-31","last_update":"2016-04-21","description":"The present study aims to examine the efficacy and safety of omega-3 polyunsaturated fatty acids for pregnant women with depressive symptoms.","other_id":"SYNCHRO-Open","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":20,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. pregnant women aged 20 years or older\r\n\r\n          2. between 12-24 weeks gestation\r\n\r\n          3. a Japanese conversational ability in Japan site or a Mandarin conversational ability\r\n             in Taiwan site to understand the scope of the present trial and to provide written\r\n             consent for study participation\r\n\r\n          4. planned to return to the hospital for checkup at 4-6 weeks after childbirth\r\n\r\n          5. an Edinburgh Postnatal Depression Scale (EPDS) score is 9 or more\r\n\r\n          6. to have good physical health judged by obstetricians.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. history and current suspicion of psychosis or bipolar I disorder or substance-related\r\n             disorder or eating disorder or personality disorder\r\n\r\n          2. the item of EPDS concerning suicide ideation is 2 or more\r\n\r\n          3. other serious psychiatric symptoms such as self-harm behavior or in need of rapid\r\n             psychiatric treatment\r\n\r\n          4. difficult to expect a normal birth (ex: fetal malformation etc.)\r\n\r\n          5. having a history of bleeding disorder such as von Willebrand's Disease\r\n\r\n          6. regular treatment with aspirin or warfarin within the last 3 months\r\n\r\n          7. a smoking habit of 40 cigarettes per day\r\n\r\n          8. regular treatment with ethyl icosapentate or regular consumption of omega-3 PUFA\r\n             supplements within the last 3 months\r\n\r\n          9. a habit of eating fish 4 times per week.\r\n      ","sponsor":"Tokyo Medical University","sponsor_type":"Other","conditions":"Pregnancy|Depression","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Omega-3 polyunsaturated fatty acids"}],"outcomes":[{"outcome_type":"primary","measure":"total score of the Hamilton Rating Scale for Depression (HAMD)","time_frame":"Twelve weeks"},{"outcome_type":"secondary","measure":"total score of HAMD","time_frame":"4-6 weeks after childbirth"},{"outcome_type":"secondary","measure":"total scores on the Edinburgh Postnatal Depression Scale (EPDS)","time_frame":"Twelve weeks, 4-6 weeks after childbirth"},{"outcome_type":"secondary","measure":"total score of the Beck Depression Inventory Ⅱ(BDI-Ⅱ)","time_frame":"Twelve weeks, 4-6 weeks after childbirth"},{"outcome_type":"secondary","measure":"major depressive disorder (MDD) as determined by the depression module of the Mini International Neuropsychiatric Interview (MINI)","time_frame":"Twelve weeks, 4-6 weeks after childbirth"},{"outcome_type":"secondary","measure":"omega-3 fatty acids concentrations in erythrocytes","time_frame":"Tweve weeks, 4-6 weeks after childbirth"},{"outcome_type":"secondary","measure":"brain-derived neurotrophic factor (BDNF) in serum","time_frame":"Twelve weeks, 4-6 weeks after childbirth"},{"outcome_type":"secondary","measure":"IF-6 in plasma","time_frame":"twelve weeks, 4-6 weeks after childbirth"},{"outcome_type":"secondary","measure":"oxytocin in plasma","time_frame":"twelve weeks, 4-6 weeks after childbirth"},{"outcome_type":"secondary","measure":"TNF-alpha in plasma","time_frame":"twelve weeks, 4-6 weeks after childbirth"},{"outcome_type":"secondary","measure":"IL-1 beta in plasma","time_frame":"twelve weeks, 4-6 weeks after childbirth"},{"outcome_type":"secondary","measure":"phospholipase A2 in plasma","time_frame":"twelve weeks, 4-6 weeks after childbirth"},{"outcome_type":"other","measure":"gestational age","time_frame":"at childbirth"},{"outcome_type":"other","measure":"gestational diabetes mellitus","time_frame":"4-6 weeks after childbirth"},{"outcome_type":"other","measure":"gestational hypertension or preeclampsia","time_frame":"4-6 weeks after childbirth"},{"outcome_type":"other","measure":"induced labour","time_frame":"at childbirth"},{"outcome_type":"other","measure":"estimated blood loss","time_frame":"at childbirth"},{"outcome_type":"other","measure":"cesarean section","time_frame":"at childbirth"},{"outcome_type":"other","measure":"operative vaginal delivery","time_frame":"at childbirth"},{"outcome_type":"other","measure":"birthweight","time_frame":"at childbirth"},{"outcome_type":"other","measure":"one minute apgar","time_frame":"4-6 weeks after childbirth"},{"outcome_type":"other","measure":"5-minute apgar","time_frame":"4-6 weeks after childbirth"},{"outcome_type":"other","measure":"neonatal intensive care unit admission","time_frame":"4-6 weeks after childbirth"},{"outcome_type":"other","measure":"cholesterol","time_frame":"twelve weeks and 4-6 weeks after childbirth"}]}
{"nct_id":"NCT03000296","start_date":"2013-10-31","phase":"N/A","enrollment":50,"brief_title":"Autologous Unselected Hematopoietic Stem Cell Transplantation for Refractory Crohn's Disease","official_title":"Autologous Unselected Hematopoietic Stem Cell Transplantation for Refractory Crohn's Disease","primary_completion_date":"2017-12-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2024-12-31","last_update":"2021-01-15","description":"This study evaluates the safety and clinical benefits of a therapeutic approach using the cyclophosphamide (Cy) + thymoglobulin (ATG) + granulocyte colony-stimulating factor (G-CSF) conditioning regimen followed by autologous hematopoietic stem cell transplantation (HSCT) rescue in the treatment of refractory Crohn's disease. Adverse events, and clinical and endoscopic conditions will be assessed at different short and long-term time points.","other_id":"autocrohnproject1","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":14,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age between 14 and 50 years (patients aged 50 - 70 can participate at the principal\r\n             investigators discretion).\r\n\r\n          2. Confirmed diagnosis of active Crohn's disease:\r\n\r\n               -  Diagnosis of Crohn's disease based on typical radiological findingsand or typical\r\n                  histology at least 6 months prior to screening.\r\n\r\n               -  Active disease at the time of registration to the trial, defined as\r\n\r\n                  *Crohn's Disease Activity Index (CDAI) > 150, and ii) Two of the following:\r\n\r\n               -  Harvey Bradshaw Index > 4\r\n\r\n               -  Endoscopic evidence of active disease confirmed by histology\r\n\r\n               -  Clear evidence of active small bowel Crohn's disease on computed tomography (CT)\r\n                  or magnetic resonance (MR) enterography.\r\n\r\n          3. Unsatisfactory course despite immunosuppressive agents (usually azathioprine,\r\n             methotrexate and two biologic agents (normally infliximab, adalimumab and/or\r\n             certolizumab) in addition to corticosteroids. Patients should have relapsing and\r\n             refractory disease despite thiopurines, methotrexate and/or\r\n             infliximab/adalimumab/certolizumab maintenance therapy or clear demonstration of\r\n             intolerance / toxicity to these drugs.\r\n\r\n          4. Current problems unsuitable for surgery or patient at risk for developing short bowel\r\n             syndrome.\r\n\r\n          5. Informed consent:\r\n\r\n               -  Prepared to undergo additional study procedures as per trial schedule\r\n\r\n               -  Patient has undergone intensive counseling about risks\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Pregnancy or unwillingness to use adequate contraception during the study, in women of\r\n             childbearing age. Unwillingness of using appropriate contraceptive measures in males.\r\n\r\n          2. Concomitant severe disease\r\n\r\n               -  renal: creatinine clearance < 30 mL/min (measured or estimated)\r\n\r\n               -  cardiac: clinical evidence of refractory congestive heart failure; left\r\n                  ventricular ejection fraction < 40% by multigated radionuclide angiography (MUGA)\r\n                  or cardiac echo; chronic atrial fibrillation necessitating oral anticoagulation;\r\n                  uncontrolled ventricular arrhythmia; pericardial effusion with hemodynamic\r\n                  consequences as evaluated by an experienced echo cardiographer.\r\n\r\n               -  pulmonary: diffusion capacity <40%\r\n\r\n               -  psychiatric disorders including active drug or alcohol abuse\r\n\r\n               -  concurrent or recent history of malignant disease (excluding non-melanoma skin\r\n                  cancer)\r\n\r\n               -  uncontrolled hypertension, defined as resting systolic blood pressure  140\r\n                  and/or resting diastolic pressure  90 despite at least 2 anti-hypertensive\r\n                  agents.\r\n\r\n               -  uncontrolled acute or chronic infection with HIV, Human T-lymphotropic virus\r\n                  (HTLV-1 or 2), hepatitis viruses or any other infection the investigators\r\n                  consider a contraindication to participation.\r\n\r\n               -  other chronic disease causing significant organ failure.\r\n      ","sponsor":"Beneficncia Portuguesa de So Paulo","sponsor_type":"Other","conditions":"Crohn's Disease|Inflammatory Bowel Diseases|Gastroenteritis","interventions":[{"intervention_type":"Procedure","name":"Procedure: Autologous Hematopoietic Stem Cell Transplantation","description":"Hematopoietic stem cell transplantation Lymphoablation followed by hematopoietic stem cell transplantation to rescue the immune system."}],"outcomes":[{"outcome_type":"primary","measure":"Safety of unselected autologous HSCT in refractory Crohn´s disease patients","time_frame":"12 months","description":"HHSCT safety will be analyzed by laboratory tests and treatment-related adverse events. Safety will be evaluated by treatment-related adverse events. All adverse events will be recorded in a standardized way and their relationship to the study protocol will be assessed at different short- and long-term time points."},{"outcome_type":"secondary","measure":"Crohn´s Disease Activity Index (CDAI)","time_frame":"12 months","description":"Duration of disease remission, defined as a CDAI ≤ 150, will be assessed at 1, 3, 6, 12 and 24 months after transplant."},{"outcome_type":"secondary","measure":"CRAIG Crohn´s Severity Score (CSS)","time_frame":"12 months","description":"The CRAIG CSS will be assessed at 1, 3, 6, 12 and 24 months after transplant."},{"outcome_type":"secondary","measure":"Inflammatory Bowel Disease Questionnaire (IBDQ)","time_frame":"24 months","description":"The IBDQ will be administered at 1, 3, 6, 12 and 24 months after transplant."},{"outcome_type":"secondary","measure":"Short Form-36 Health Survey (SF-36)","time_frame":"24 months","description":"The SF-36 will be administered at 1, 3, 6, 12 and 24 months after transplant."},{"outcome_type":"secondary","measure":"Simple Endoscopic Activity Score (SES)","time_frame":"24 months","description":"The SES will be assessed at 6, 12 and 24 months after HSCT."},{"outcome_type":"secondary","measure":"Crohn's Disease Endoscopic Index of Severity (CDEIS)","time_frame":"24 months","description":"The CDEIS will be assessed at 6, 12 and 24 months after HSCT."},{"outcome_type":"secondary","measure":"Rutgeerts endoscopic score","time_frame":"24 months","description":"Rutgeerts endoscopic score will be assessed at 6, 12 and 24 months after HSCT."},{"outcome_type":"secondary","measure":"Harvey & Bradshaw Index (HBI)","time_frame":"24 months","description":"The HBI will be assessed at 1, 3, 6, 12 and 24 months after HSCT."}]}
{"nct_id":"NCT01968954","start_date":"2013-10-31","phase":"Phase 3","enrollment":711,"brief_title":"Randomized Clinical Trial Of Bococizumab (PF-04950615; RN316) In Subjects With Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events","official_title":"A Phase 3 Double-blind,Randomized, Placebo-controlled,Parallel-group Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 In Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events","primary_completion_date":"2016-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-04-30","last_update":"2017-05-17","description":"This study is a multicenter, randomized study in subjects with high cholesterol receiving highly effective statins to assess the efficacy, safety and tolerability of Bococizumab (PF-04950615;RN316) to lower LDL-C.","other_id":"B1481019","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Treated with a statin.\r\n\r\n          -  Fasting LDL-C > 70 mg/dL and triglyceride <=400 mg/dL.\r\n\r\n          -  High or very high risk of incurring a cardiovascular event.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnant or breastfeeding females.\r\n\r\n          -  Cardiovascular or cerebrovascular event of procedures during the past 30 days.\r\n\r\n          -  Congestive heart failure NYHA class IV.\r\n\r\n          -  Poorly controlled hypertension.\r\n      ","sponsor":"Pfizer","sponsor_type":"Industry","conditions":"Hyperlipidemia","interventions":[{"intervention_type":"Other","name":"Other: Placebo","description":"subcutaneous injection, every 2 weeks for 12 months"},{"intervention_type":"Drug","name":"Drug: Bococizumab (PF-04950615;RN316)","description":"150 mg every 2 weeks, subcutaneous injection, 12 months"}],"outcomes":[{"outcome_type":"primary","measure":"Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12","time_frame":"Baseline, Week 12"},{"outcome_type":"secondary","measure":"Percent Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52","time_frame":"Baseline, Week 12, 24, 52"},{"outcome_type":"secondary","measure":"Percent Change From Baseline in Non- High Density Lipoprotein-Cholesterol (Non HDL-C) at Week 12, 24 and 52","time_frame":"Baseline, Week 12, 24, 52"},{"outcome_type":"secondary","measure":"Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52","time_frame":"Baseline, Week 12, 24, 52"},{"outcome_type":"secondary","measure":"Percent Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52","time_frame":"Baseline, Week 12, 24, 52"},{"outcome_type":"secondary","measure":"Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52","time_frame":"Baseline, Week 12, 24, 52"},{"outcome_type":"secondary","measure":"Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Participants With Primary Hyperlipidemia","time_frame":"Baseline, Week 12","description":"Participants with primary hyperlipidemia are defined as participants with triglycerides (TG) level less than (<) 200 milligram per decilitre (mg/dL) (2.26 millimoles per litre [mmol/L]) at pre-randomization."},{"outcome_type":"secondary","measure":"Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Participants With Mixed Dyslipidemia","time_frame":"Baseline, Week 12","description":"Participants with mixed dyslipidemia are defined as TG level greater than or equal to (>=) 200 mg/dL (2.26 mmol/L) at pre-randomization."},{"outcome_type":"secondary","measure":"Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 24 and 52","time_frame":"Baseline, Week 24, 52"},{"outcome_type":"secondary","measure":"Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 by Triglyceride Cut-off","time_frame":"Baseline, Week 24, 52","description":"Percent change from baseline in fasting LDL-C among participants with TG cut-off of <200 mg/dL and >=200 mg/dL (2.26 mmol/L) were reported in this outcome measure."},{"outcome_type":"secondary","measure":"Percent Change From Baseline in Fasting Triglyceride (TG) at Week 12, 24 and 52","time_frame":"Baseline, Week 12, 24, 52"},{"outcome_type":"secondary","measure":"Percent Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52","time_frame":"Baseline, Week 12, 24, 52"},{"outcome_type":"secondary","measure":"Percent Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52","time_frame":"Baseline, Week 12, 24, 52"},{"outcome_type":"secondary","measure":"Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Week 12, 24 and 52","time_frame":"Baseline, Week 12, 24, 52"},{"outcome_type":"secondary","measure":"Absolute Change From Baseline in Fasting Low Density Lipoprotein-C (LDL-C) at Week 12 by Trigylceride Cut-Off","time_frame":"Baseline, Week 12","description":"Absolute change from baseline among participants with TG cut-off of <200 mg/dL and >=200 mg/dL (2.26 mmol/L) were reported in this outcome measure."},{"outcome_type":"secondary","measure":"Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12, 24 and 52","time_frame":"Baseline, Week 12, 24, 52"},{"outcome_type":"secondary","measure":"Absolute Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52","time_frame":"Baseline, Week 12, 24, 52"},{"outcome_type":"secondary","measure":"Absolute Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24 and 52","time_frame":"Baseline, Week 12, 24, 52"},{"outcome_type":"secondary","measure":"Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52","time_frame":"Baseline, Week 12, 24, 52"},{"outcome_type":"secondary","measure":"Absolute Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52","time_frame":"Baseline, Week 12, 24, 52"},{"outcome_type":"secondary","measure":"Absolute Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52","time_frame":"Baseline, Week 12, 24, 52"},{"outcome_type":"secondary","measure":"Absolute Change From Baseline in Ratio of Fasting Total Cholesterol to High Density Lipoprotein-Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52","time_frame":"Baseline, Week 12, 24, 52"},{"outcome_type":"secondary","measure":"Absolute Change From Baseline in Ratio of Apolipoprotein B to ApolipoproteinA-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52","time_frame":"Baseline, Week 12, 24, 52"},{"outcome_type":"secondary","measure":"Percentage of Participants Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (2.59 Millimoles Per Litre) at Week 12, 24 and 52","time_frame":"Week 12, 24 and 52"},{"outcome_type":"secondary","measure":"Percentage of Participants Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (1.81 Millimoles Per Litre) at Week 12, 24 and 52","time_frame":"Week 12, 24 and 52"},{"outcome_type":"secondary","measure":"Plasma PF-04950615 Concentrations at Week 12, 24 and 52","time_frame":"Week 12, 24, 52"},{"outcome_type":"secondary","measure":"Number of Participants With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions","time_frame":"Baseline up to the end of study (up to 58 weeks)","description":"Type 1 hypersensitivity or allergic reactions were possible in response to any injected protein and included shortness of breath, urticaria, anaphylaxis and angioedema. Type 3 hypersensitivity reactions were similar to Type 1 hypersensitivity reactions but were likely to be delayed from the time of injection and included symptoms such as rash, urticaria, polyarthritis, myalgia's, polysynovitis, fever and if severe then included glomerulonephritis as well. Injection site reactions included injection site bruising, discolouration, erythema, haematoma, haemorrhage, nodule, induration, pain, pruritus and rash. Participants with type 1 or type 3 hypersensitivity reactions and participants with injection site reactions were reported in this outcome measure."},{"outcome_type":"secondary","measure":"Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)","time_frame":"Baseline up to the end of study (up to 58 weeks)","description":"Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. Participants with their ADA titer >=6.23 were considered to be ADA positive and participants with their nAb titer >=1.58 were considered to be nAb positive."},{"outcome_type":"other","measure":"Absolute Change From Baseline in Triglyceride (TG) at Week 12, 24 and 52","time_frame":"Baseline, Week 12, 24, 52"},{"outcome_type":"other","measure":"Absolute Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52","time_frame":"Baseline, Week 12, 24, 52"},{"outcome_type":"other","measure":"Absolute Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52","time_frame":"Baseline, Week 12, 24, 52"}]}
{"nct_id":"NCT01966458","start_date":"2013-10-31","phase":"N/A","enrollment":494,"brief_title":"A Clinical Trial to Evaluate the HeartWare Ventricular Assist System (ENDURANCE SUPPLEMENTAL TRIAL)","official_title":"A Prospective, Randomized, Controlled, Unblinded, Multi-Center Clinical Trial to Evaluate the HeartWare Ventricular Assist Device System for Destination Therapy of Advanced Heart Failure","primary_completion_date":"2016-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-08-31","last_update":"2020-10-23","description":"This is a prospective, randomized, controlled, unblinded, multi-center evaluation of safety and efficacy in patients implanted with a HeartWare HVAD who receive improved blood pressure management. Subjects have chronic Stage D or NYHA Class IIIB/IV left ventricular failure who have received and failed optimal medical therapy, and who are ineligible for cardiac transplantation.","other_id":"HW004-A","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Must be 18 years of age at consent\r\n\r\n          2. Body Surface Area (BSA)  1.2 m2\r\n\r\n          3. Patients with advanced heart failure symptoms (Class IIIB or IV) who are: (patient\r\n             must meet one of the following)a. On optimal medical management, including dietary\r\n             salt restriction and diuretics, for at least 45 out of the last 60 days and are\r\n             failing to respond; or b. In Class III or Class IV heart failure for at least 14 days,\r\n             and dependent on intra-aortic balloon pump (IABP) for 7 days and/or inotropes for at\r\n             least 14 days\r\n\r\n          4. Left ventricular ejection fraction  25%\r\n\r\n          5. LVAD implant is intended as destination therapy\r\n\r\n          6. Must be able to receive either the HeartWare HVAD or control LVAD\r\n\r\n          7. Patient must agree to participate in and comply with an improved blood pressure\r\n             management program, including maintenance of a patient diary.\r\n\r\n          8. Female patients of childbearing potential must agree to use adequate contraceptive\r\n             precautions (defined as oral contraceptives, intrauterine devices, surgical\r\n             contraceptives or a combination of condom and spermicide) for the duration of the\r\n             study.\r\n\r\n          9. The patient or legally authorized representative has signed the informed consent form\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Body Mass Index (BMI) > 40\r\n\r\n          2. Existence of any ongoing mechanical circulatory support (MCS) other than an\r\n             intra-aortic balloon pump (IABP)\r\n\r\n          3. Prior cardiac transplant.\r\n\r\n          4. History of confirmed, untreated abdominal or thoracic aortic aneurysm > 5 cm.\r\n\r\n          5. Cardiothoracic surgery within 30 days of randomization.\r\n\r\n          6. Acute myocardial infarction within 14 days of implant as diagnosed by ST or T wave\r\n             changes on the ECG, diagnostic biomarkers, ongoing pain and hemodynamic abnormalities\r\n             as described (Figure 2) in the guidelines published in ACC/AHA 2007 Guidelines for the\r\n             Management of Patients with Unstable Angina/Non-ST-Elevation Myocardial Infarction ;.\r\n\r\n          7. Patients eligible for cardiac transplantation\r\n\r\n          8. On ventilator support for > 72 hours within the four days immediately prior to\r\n             randomization and implant.\r\n\r\n          9. Pulmonary embolus within three weeks of randomization as documented by computed\r\n             tomography (CT) scan or nuclear scan.\r\n\r\n         10. Symptomatic cerebrovascular disease, stroke within 180 days of randomization or > 80%\r\n             stenosis of carotid or cranial vessels.\r\n\r\n         11. Uncorrected moderate to severe aortic insufficiency. Correction may include repair or\r\n             bioprosthesis at the time of implant.\r\n\r\n         12. Severe right ventricular failure as defined by the anticipated need for right\r\n             ventricular assist device (RVAD) support or extracorporeal membrane oxygenation (ECMO)\r\n             at the time of screening/randomization or right atrial pressure > 20 mmHg on multiple\r\n             inotropes or right ventricular ejection fraction (RVEF) <15% with clinical signs of\r\n             severe right heart failure (e.g. Lower extremity edema, ascites or pleural effusions\r\n             refractory to treatment with diuretics and two inotropic drugs).\r\n\r\n         13. Active, uncontrolled infection diagnosed by a combination of clinical symptoms and\r\n             laboratory testing, including but not limited to, continued positive cultures,\r\n             elevated temperature and white blood cell (WBC) count, hypotension, tachycardia,\r\n             generalized malaise despite appropriate antibiotic, antiviral or antifungal treatment.\r\n\r\n         14. Uncorrected thrombocytopenia or generalized coagulopathy (e.g., platelet count <\r\n             75,000, INR > 2.0 or PTT > 2.5 times control in the absence of anticoagulation\r\n             therapy).\r\n\r\n         15. Intolerance to anticoagulant or antiplatelet therapies or any other peri- or\r\n             postoperative therapy that the investigator may administer based upon the patient's\r\n             health status.\r\n\r\n         16. Serum creatinine > 3.0 mg/dL within 72 hours of randomization or requiring dialysis or\r\n             ultrafiltration.\r\n\r\n         17. Specific liver enzymes [AST (SGOT) and ALT (SGPT] > 3 times upper limit of normal\r\n             within 72 hours of randomization.\r\n\r\n         18. A total bilirubin > 3 mg/dl within 72 hours of randomization, or biopsy proven liver\r\n             cirrhosis or portal hypertension.\r\n\r\n         19. Pulmonary vascular resistance is demonstrated to be unresponsive to pharmacological\r\n             manipulation and the PVR > 6 Wood units.\r\n\r\n         20. Patients with a mechanical heart valve.\r\n\r\n         21. Etiology of heart failure is due to, or associated with, uncorrected thyroid disease,\r\n             obstructive cardiomyopathy, pericardial disease, amyloidosis, active myocarditis or\r\n             restrictive cardiomyopathy\r\n\r\n         22. History of severe COPD or severe restrictive lung disease (e.g. FEV1 <50%)\r\n\r\n         23. Participation in any other study involving investigational drugs or devices\r\n\r\n         24. Severe illness, other than heart disease, which would limit survival to < 3 years\r\n\r\n         25. Peripheral vascular disease with rest pain or ischemic ulcers of the extremities\r\n\r\n         26. Pregnancy\r\n\r\n         27. Patient unwilling or unable to comply with study requirements\r\n\r\n         28. Technical obstacles, which pose an inordinately high surgical risk, in the judgment of\r\n             the investigator\r\n      ","sponsor":"Medtronic Cardiac Rhythm and Heart Failure","sponsor_type":"Industry","conditions":"Chronic Heart Failure","interventions":[{"intervention_type":"Device","name":"Device: HeartWare VAS (HVAD)","description":"The HeartWare VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use."},{"intervention_type":"Device","name":"Device: Control LVAD","description":"Any FDA-approved LVAD for destination therapy."}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants With Neurologic Injury","time_frame":"Implant to 12 Months","description":"The primary endpoint is the percent of participants at 12 months on the originally implanted device with neurologic injury, defined as a stroke with Modified Rankin Scale (MRS) > 0 at 24-weeks post-stroke, or a transient ischemic attack (TIA), or a spinal cord infarction (SCI). The Modified Rankin Scale is scored from 0 to 6, where 0 indicates an absence of symptoms and 6 indicates death. A score of 4 or higher indicates moderately severe or greater disability."},{"outcome_type":"secondary","measure":"Number of HeartWare VAS Participants With Stroke/TIA","time_frame":"Implant to 12 Months","description":"The first secondary endpoint is the number of HeartWare VAS participants with stroke/TIA at 12 months on the originally implanted device."},{"outcome_type":"secondary","measure":"Number of Participants With Stroke-Free Success","time_frame":"Implant to 12 Months","description":"Success is defined as alive on the originally implanted device, electively transplanted or explanted due to subject recovery and free from disabling stroke (Modified Rankin Scale >=4)."}]}
{"nct_id":"NCT01924208","start_date":"2013-10-31","phase":"Phase 3","enrollment":180,"brief_title":"Tonsillar Cytokine Expression After Allergen and/or Virus Intervention","official_title":"T Cell and Interferon Expression in Tonsils After Sublingual Immunotherapy and/or Nasal Live Attenuated Influenza Vaccine","primary_completion_date":"2016-09-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2016-09-30","last_update":"2016-04-21","description":"Hypotheses 1. Immunotherapy induces tolerogenic effects to allergens in T cell regulation in tonsils. 2. Influenza vaccination induces a strong interferon response and decreases Th2 response in tonsils. 3. Influenza vaccination as an adjuvant on immunotherapy induces a better response to immunotherapy.","other_id":"Tons2","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":4,"maximum_age":30,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  elective tonsillectomy with or without adenotomy according to clinical indication\r\n\r\n          -  age >4 and <30 years\r\n\r\n          -  written informed consent from the study subject or his/her guardian\r\n\r\n          -  Fluenz will be used for ages >4 and <30 years, i.e. off-label use of ages >18 and <30\r\n             years\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  systemic anti-inflammatory medication within prior 4 weeks\r\n\r\n          -  systemic diseases affecting the immune system e.g. autoimmune diseases, immune complex\r\n             diseases or immune deficiency diseases other than allergy, asthma or atopic dermatitis\r\n\r\n          -  malignancy, depression, psychiatric illness or medication; planned vaccination during\r\n             the study period (vaccinations should not be given during study period)\r\n\r\n          -  forced expiratory volume in 1 second (FEV1) is under 80% of normal value or asthma is\r\n             in a bad balance for those patients who would participate in the immunotherapy\r\n\r\n          -  sublingual grass pollen will not be given for children under the age of 5\r\n\r\n          -  additional exclusion criteria for Grazax include hypersensitivity to any of the\r\n             excipients (gelatin [fish source], mannitol, sodium hydroxide), inflammatory\r\n             conditions in the oral cavity with severe symptoms such as oral lichen planus with\r\n             ulcerations or severe oral mycosis, patients with uncontrolled or severe asthma (in\r\n             adults: FEV1 < 70% of predicted value after adequate pharmacologic treatment, in\r\n             children: FEV1 < 80% of predicted value after adequate pharmacologic treatment)\r\n\r\n          -  addition exclusion criteria for Fluenz include hypersensitivity to the active\r\n             substances, to any of the excipients (sucrose, dibasic potassium phosphate, monobasic\r\n             potassium phosphate, gelatin [porcine, Type A], arginine hydrochloride, monosodium\r\n             glutamate monohydrate, gentamicin [a possible trace residue], eggs or to egg proteins\r\n             [e.g. ovalbumin] and children and adolescents younger than 18 years of age receiving\r\n             salicylate therapy because of the association of Reye's syndrome with salicylates and\r\n             wild-type influenza infection\r\n      ","sponsor":"Turku University Hospital","sponsor_type":"Other","conditions":"Healthy","interventions":[{"intervention_type":"Biological","name":"Biological: Timothy, Phleum pretense","description":"Allergen. Grazax sublingual 75.000 SQ-T tablet (extracted from timothy, Phleum pretense), once daily until operation (ALK-Abell, Hrsholm, Denmark) (n=30) ."},{"intervention_type":"Biological","name":"Biological: Live attenuated influenza virus","description":"Virus. Fluenz, nasal live attenuated influenza vaccine, one 0.2 mL dose (MedImmune, Gaithersburg, USA) (n=60, 50:50 atopic:non-atopic)."},{"intervention_type":"Procedure","name":"Procedure: Timothy + attenuated influenza virus","description":"Allergen. Grazax sublingual 75.000 SQ-T tablet (extracted from timothy, Phleum pretense), once daily until operation (ALK-Abell, Hrsholm, Denmark) + Virus. Fluenz, nasal live attenuated influenza vaccine, one 0.2 mL dose (MedImmune, Gaithersburg, USA) (n=30)."}],"outcomes":[{"outcome_type":"primary","measure":"Expressions of interferon and T cell and closely related cytokines and transcription factors in tonsils.","time_frame":"Up to 3 years","description":"Expressions of IFN-α, IFN-β, IFN-γ, IL-10, IL-13, IL-17, IL-28, IL-29, IL-37, TGF-β, FOXP3, GATA3, RORC2 and Tbet will be analyzed by quantitative real-time PCR."}]}
{"nct_id":"NCT01967381","start_date":"2013-10-31","phase":"Early Phase 1","enrollment":24,"brief_title":"Targeting GABA and Opioid Systems for a Pharmacotherapy for Methamphetamine Abuse","official_title":"Targeting GABA and Opioid Systems for a Pharmacotherapy for Methamphetamine Abuse","primary_completion_date":"2018-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-09-30","last_update":"2018-09-14","description":"The research proposed in this application will determine the initial efficacy, safety and tolerability of a novel drug combination, oxazepam (Serax) and naltrexone (Revia), as a pharmacotherapy for methamphetamine (Desoxyn) dependence. A rigorous, inpatient human laboratory study will be conducted. The proposed study is innovative and important because it will provide the impetus for the conduct of double blind, placebo-controlled trials to further demonstrate the efficacy of combined oxazepam and naltrexone for managing methamphetamine dependence.","other_id":"R01DA033394","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Basic Science","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Lifetime methamphetamine use\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians\r\n             deem clinically significant\r\n\r\n          -  Current or past histories of substance abuse or dependence that are deemed by the\r\n             study physicians to interfere with study completion\r\n\r\n          -  History of serious physical disease, current physical disease, impaired cardiovascular\r\n             functioning, chronic obstructive pulmonary disease, history of seizure or current or\r\n             past histories of serious psychiatric disorder that in the opinion of the study\r\n             physician would interfere with study participation will be excluded from participation\r\n\r\n          -  Females not currently using effective birth control\r\n\r\n          -  Contraindications to methamphetamine (Desoxyn), oxazepam (Serax) or naltrexone\r\n             (Revia)\r\n      ","sponsor":"University of Kentucky","sponsor_type":"Other","conditions":"Methamphetamine Abuse|Methamphetamine Dependence","interventions":[{"intervention_type":"Drug","name":"Drug: Methamphetamine (Desoxyn)","description":"The pharmacodynamic effects of methamphetamine (Desoxyn) will be determined during placebo, oxazepam (Serax), naltrexone (Revia) and combined oxazepam and naltrexone maintenance."}],"outcomes":[{"outcome_type":"primary","measure":"Reinforcing Effects","time_frame":"After at least four days of placebo, oxazepam (Serax®), naltrexone (Revia®) or oxazepam and naltrexone maintenance","description":"The reinforcing effects of methamphetamine will be determined using a self-administration procedure in which subjects choose to take previously sampled doses. Reinforcing effects are measured during maintenance on placebo, oxazepam (Serax®), naltrexone (Revia®), and oxazepam and naltrexone combined."},{"outcome_type":"secondary","measure":"Subjective Effects","time_frame":"12 sessions over approximately 4 week inpatient admissions","description":"Subjects will complete subjective effects measures during six sessions while they are admitted to our inpatient unit. These items will ask about drug effects and general mood."},{"outcome_type":"secondary","measure":"Physiological and Side Effects","time_frame":"Daily over approximately 4 week inpatient admissions","description":"Physiological and side effects measures will be completed daily while subjects are admitted to our inpatient unit. Physiological measures include heart rate and blood pressure. Side Effects questions will query subjects about common effects of centrally active medications."}]}
{"nct_id":"NCT01989598","start_date":"2013-10-30","phase":"Phase 2","enrollment":25,"brief_title":"Trametinib and Akt Inhibitor GSK2141795 in Treating Patients With Relapsed or Refractory Multiple Myeloma","official_title":"A Phase 2 Study of Sequential Trametinib and GSK2141795 in Relapsed or Refractory Multiple Myeloma","primary_completion_date":"2019-08-31","study_type":"Interventional","rec_status":"Active, not recruiting","last_update":"2020-11-10","description":"This phase II trial studies how well trametinib and Akt inhibitor GSK2141795 work in treating patients with multiple myeloma that has come back (relapsed) or that does not respond to treatment (refractory). Trametinib and Akt inhibitor GSK2141795 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.","other_id":"NCI-2013-02148","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients must have histologically or cytologically confirmed multiple myeloma not\r\n             otherwise specified (NOS) (10028566)\r\n\r\n          -  Patients must have measurable disease as defined as at least one of the following\r\n             (these baseline laboratory studies for determining eligibility must be obtained within\r\n             28 days prior to enrollment):\r\n\r\n               -  Serum M-protein >= 0.5 g/dl (>= 5 g/l)\r\n\r\n               -  Urine M-protein >= 200 mg/24 h\r\n\r\n               -  Serum free light chains (FLC) assay: involved FLC level >= 10 mg/dl (>= 100 mg/l)\r\n                  and an abnormal serum free light chain ratio (< 0.26 or > 1.65)\r\n\r\n               -  Biopsy proven plasmacytoma (should be measured within 28 days of first study drug\r\n                  administration); prior biopsy is acceptable\r\n\r\n               -  If the serum protein electrophoresis is unreliable for routine M-protein\r\n                  measurement, quantitative immunoglobulin levels on nephelometry or turbidimetry\r\n                  will be followed\r\n\r\n          -  A diagnosis of multiple myeloma (MM) and documentation of relapsed or\r\n             relapse/refractory status following at least 2 prior lines of therapy\r\n\r\n          -  Documented laboratory (lab) results confirming tumor mutational status must be\r\n             obtained at screening; patients in whom mutational status cannot be determined will be\r\n             deemed ineligible\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)\r\n\r\n          -  Life expectancy of greater than 6 months\r\n\r\n          -  Able to swallow and retain orally-administered medication and does not have any\r\n             clinically significant gastrointestinal abnormalities that may alter absorption such\r\n             as malabsorption syndrome or major resection of the stomach or bowels\r\n\r\n          -  All prior treatment-related toxicities must be Common Terminology Criteria for Adverse\r\n             Events (CTCAE) version (v)4 grade =< 1 (except alopecia) at the time of registration;\r\n             subjects with toxicities attributed to prior anti-cancer therapy which are not\r\n             expected to resolve and result in long lasting sequelae are permitted to enroll\r\n\r\n          -  Absolute neutrophil count (ANC) >= 1.0 x 10^9/L\r\n\r\n          -  Hemoglobin >= 8 g/dL\r\n\r\n          -  Platelets >= 50 x 10^9/L\r\n\r\n          -  Albumin >= 2.5 g/dL\r\n\r\n          -  Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (isolated bilirubin\r\n             > 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%)\r\n\r\n          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x\r\n             institutional ULN\r\n\r\n          -  Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockroft-Gault\r\n             formula) >= 30 mL/min OR 24-hour urine creatinine clearance >= 30 mL/min\r\n\r\n          -  Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin\r\n             time (PTT) =< 1.5 x institutional ULN\r\n\r\n          -  Fasting serum glucose < 126 mg/dl (7 mmol/l)\r\n\r\n          -  Left ventricular ejection fraction (LVEF) >= institutional lower limit of normal (LLN)\r\n             by echocardiogram (ECHO) or multi gated acquisition scan (MUGA)\r\n\r\n          -  Subjects that have been previously diagnosed with type 2 diabetes or steroid-induced\r\n             diabetes must also meet the additional following criteria:\r\n\r\n               -  Diagnosed with diabetes >= 6 months prior to enrollment\r\n\r\n               -  Hemoglobin A1C (HbA1C) =< 8% at screening visit\r\n\r\n          -  Women of child-bearing potential and men must agree to use adequate contraception\r\n             (hormonal or barrier method of birth control; abstinence) prior to study entry and for\r\n             the duration of study participation; women of child-bearing potential must have a\r\n             negative serum pregnancy test within 7 days prior to the start of protocol therapy;\r\n             should a woman become pregnant or suspect she is pregnant while she or her partner is\r\n             participating in this study, she should inform her treating physician immediately; men\r\n             treated or enrolled on this protocol must also agree to use adequate contraception\r\n             prior to the study, for the duration of study participation, and 4 months after\r\n             completion of trametinib administration\r\n\r\n          -  Ability to understand and the willingness to sign a written informed consent document\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of another malignancy; exception: patients who have been disease-free for 3\r\n             years, or patients with a history of completely resected non-melanoma skin cancer\r\n             and/or patients with indolent second malignancies, are eligible; consult the Cancer\r\n             Therapy Evaluation Program (CTEP) medical monitor if unsure whether second\r\n             malignancies meet the requirements specified above\r\n\r\n          -  History of interstitial lung disease or pneumonitis\r\n\r\n          -  Diabetes mellitus currently requiring insulin; subjects with a history of\r\n             steroid-induced hyperglycemia may be enrolled provided that HbA1C at screening visit\r\n             is =< 8%\r\n\r\n          -  Any major surgery, extensive radiotherapy, chemotherapy with delayed toxicity,\r\n             biologic therapy, or immunotherapy within 28 days prior to randomization and/or daily\r\n             or weekly chemotherapy or other approved anti-myeloma therapy without the potential\r\n             for delayed toxicity within 14 days prior to registration\r\n\r\n          -  Use of other investigational drugs within 28 days preceding the first dose of\r\n             trametinib and during the study\r\n\r\n          -  Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression\r\n\r\n          -  Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs\r\n             chemically related to trametinib or excipients or to dimethyl sulfoxide (DMSO) or\r\n             GSK214795\r\n\r\n          -  Current use of a prohibited medication; the following medications or non-drug\r\n             therapies are prohibited:\r\n\r\n               -  Other anti-cancer therapy while on study treatment; (note: megestrol [Megace] if\r\n                  used as an appetite stimulant is allowed)\r\n\r\n               -  Concurrent treatment with bisphosphonates is permitted; however, treatment must\r\n                  be initiated prior to the first dose of study therapy; prophylactic use of\r\n                  bisphosphonates in patients without bone disease is not permitted, except for the\r\n                  treatment of osteoporosis\r\n\r\n               -  The concurrent use of all herbal supplements is prohibited during the study\r\n                  (including, but not limited to, St. John's wort, kava, ephedra [ma huang], gingko\r\n                  biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)\r\n\r\n          -  In vitro data indicate that GSK2141795 is a cytochrome P450, family 3, subfamily A,\r\n             polypeptide 4 (CYP3A4) substrate; drugs that potently inhibit CYP3A4 could lead to\r\n             increased GSK2141795 exposure in subjects, and should either be prohibited or used\r\n             with caution; drugs which are strong inducers of cytochrome P450, family 3, subfamily\r\n             A (CYP3A) and may result in lower exposures of GSK2141795 should also be prohibited;\r\n             GSK2141795 also appears to be a moderate in vitro inhibitor of cytochrome P450, family\r\n             2, subfamily C, polypeptide 8 (CYP2C8) (50% inhibitory concentration [IC50] 3 mcM) and\r\n             CYP3A4 (IC50 11 mcM); drugs that are substrates of CYP3A4 or CYP2C8 with a narrow\r\n             therapeutic index may be prohibited; drugs that are sensitive substrates of CYP3A4 or\r\n             CYP2C8 should be used with caution\r\n\r\n          -  History or current evidence/risk of retinal vein occlusion (RVO) or retinal pigment\r\n             epithelial detachment (RPED):\r\n\r\n               -  History of RVO or RPED, or predisposing factors to RVO or RPED (e.g.,\r\n                  uncontrolled glaucoma or ocular hypertension, uncontrolled systemic disease such\r\n                  as hypertension, diabetes mellitus, or history of hyperviscosity or\r\n                  hypercoagulability syndromes)\r\n\r\n               -  Visible retinal pathology as assessed by ophthalmic exam that is considered a\r\n                  risk factor for RVO or RPED such as evidence of new optic disc cupping, evidence\r\n                  of new visual field defects, and intraocular pressure > 21 mmHg\r\n\r\n          -  History or evidence of cardiovascular risk including any of the following:\r\n\r\n               -  Left ventricular ejection fraction (LVEF) < LLN\r\n\r\n               -  A QT interval corrected for heart rate using the Bazett's formula Fridericia\r\n                  corrected QT interval (QTcB) >= 480 msec (>= 500 msec for subjects with bundle\r\n                  branch block)\r\n\r\n               -  History or evidence of current clinically significant uncontrolled arrhythmias\r\n                  (exception: patients with controlled atrial fibrillation for > 30 days prior to\r\n                  randomization are eligible)\r\n\r\n               -  Other clinically significant electrocardiogram (ECG) abnormalities including\r\n                  second (2nd) degree (type II) or third (3rd) degree atrioventricular (AV) block\r\n\r\n               -  Subject with intra-cardiac defibrillators or pacemakers\r\n\r\n               -  History of acute coronary syndromes (including myocardial infarction and unstable\r\n                  angina), coronary angioplasty, or stenting within 6 months prior to randomization\r\n\r\n               -  History or evidence of current >= class II congestive heart failure as defined by\r\n                  the New York Heart Association (NYHA) functional classification system\r\n\r\n               -  Treatment-refractory hypertension defined as a blood pressure of systolic > 140\r\n                  mmHg and/or diastolic > 90 mmHg which cannot be controlled by anti-hypertensive\r\n                  therapy\r\n\r\n               -  Known cardiac metastases\r\n\r\n          -  Known human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C\r\n             virus (HCV) infection (with the exception of chronic or cleared HBV and HCV infection,\r\n             which will be allowed)\r\n\r\n          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active\r\n             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac\r\n             arrhythmia, or psychiatric illness/social situations that would limit compliance with\r\n             study requirements\r\n\r\n          -  The study drug must not be administered to pregnant women or nursing mothers; women of\r\n             childbearing potential should be advised to avoid pregnancy and use effective methods\r\n             of contraception; men with a female partner of childbearing potential must have either\r\n             had a prior vasectomy or agree to use effective contraception; if a female patient or\r\n             a female partner of a patient becomes pregnant while the patient receives trametinib,\r\n             the potential hazard to the fetus should be explained to the patient and partner (as\r\n             applicable); these potential risks may also apply to GSK2141795\r\n      ","sponsor":"National Cancer Institute (NCI)","sponsor_type":"NIH","conditions":"Recurrent Plasma Cell Myeloma|Refractory Plasma Cell Myeloma","interventions":[{"intervention_type":"Other","name":"Other: Laboratory Biomarker Analysis","description":"Correlative studies"},{"intervention_type":"Other","name":"Other: Pharmacological Study","description":"Correlative studies"},{"intervention_type":"Drug","name":"Drug: Trametinib","description":"Given PO"},{"intervention_type":"Drug","name":"Drug: Uprosertib","description":"Given PO"}],"outcomes":[{"outcome_type":"secondary","measure":"PFS","time_frame":"Time from the date of start of treatment to the date of documented progression (based on IMWG criteria) or death due to any cause, assessed up to 4 weeks","description":"Summarized for each cohort using the Kaplan-Meier method."},{"outcome_type":"primary","measure":"ORR evidenced by confirmed response rate, defined as number of patients with partial response or better by International Myeloma Working Group (IMWG) criteria divided by the number of patients in the applicable group (biomarker positive or negative)","time_frame":"Up to 4 weeks","description":"The patient will be classified as having had a response if he/she has a confirmed response (i.e., a stringent complete response, or complete response or near complete response or very good partial response or partial response noted as the objective status of two consecutive assessments). The rate of minor response and PD will also be observed."},{"outcome_type":"secondary","measure":"DOR","time_frame":"From the time measurement criteria are met for CR or PR (whichever is first recorded) until first date that recurrent or progressive disease is objectively documented or to death due to multiple myeloma, assessed up to 4 weeks","description":"Summarized for each cohort using the Kaplan-Meier method."},{"outcome_type":"secondary","measure":"ORR after the addition of AKT inhibitor GSK2141795 to trametinib in patients who have developed progressive disease or have achieved less than a PR","time_frame":"Up to 4 weeks"},{"outcome_type":"secondary","measure":"Incidence of adverse event reactions reported according to CTCAE v4.0","time_frame":"Up to 4 weeks","description":"Reported by type, frequency, and severity."},{"outcome_type":"other","measure":"Pharmacodynamic markers of trametinib","time_frame":"Baseline, day 1 of course 2, progression","description":"Analyses will be descriptively summarized."},{"outcome_type":"other","measure":"Chromosomal abnormalities as determined by FISH","time_frame":"Up to 4 weeks","description":"Analyses will be descriptively summarized."},{"outcome_type":"other","measure":"Tumor mutational profile by next generation sequencing","time_frame":"Up to 4 weeks","description":"Analyses will be descriptively summarized."},{"outcome_type":"other","measure":"Change in RAS-MEK-ERK activation determined by phospho-flow cytometry and RPPA","time_frame":"Baseline to up to 4 weeks","description":"Analyses will be descriptively summarized."},{"outcome_type":"other","measure":"Detection of RAS and RAF mutations using cfDNA","time_frame":"Up to 4 weeks","description":"Ultra-deep sequencing will be performed on cfDNA to assess the feasibility of detecting mutations of NRAS, KRAS and BRAF from peripheral blood samples."}]}
{"nct_id":"NCT01959347","start_date":"2013-10-28","phase":"Phase 3","enrollment":480,"brief_title":"Combined Treatment for Mixed Incontinence","official_title":"Effects of Surgical Treatment Enhanced With Exercise for Mixed Urinary Incontinence (ESTEEM)","primary_completion_date":"2017-08-09","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-09-29","last_update":"2020-05-14","description":"The overarching goal of this randomized trial is to estimate the effect of combined midurethral sling (MUS) and peri-operative behavioral/pelvic floor therapy (BPTx) compared to MUS alone on successful treatment of MUI symptoms in 472 women. Secondary objectives include estimating the effect of combined treatment compared to MUS on improving overactive bladder (OAB) and stress urinary incontinence (SUI) outcomes separately, need for additional treatment, time to failure and identifying predictors of poor outcomes in this MUI population. A supplemental study, The Human Microbiome Study of ESTEEM, will evaluate the urinary and vaginal microbiome as it relates to women with MUI, their treatment and unaffected controls.","other_id":"PFDN-26P01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"Female","minimum_age":21,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Presence of both SUI and UUI on bladder diary; and > 2 IEs/3 days\r\n\r\n               1. > 1 Stress IE/3 day diary\r\n\r\n               2. > 1 Urge IE/3 day diary\r\n\r\n          2. Reporting at least \"moderate bother\" from UUI item on the UDI \"Do you usually\r\n             experience urine leakage associated with a feeling of urgency, that is a strong\r\n             sensation of needing to go to the bathroom?\"\r\n\r\n          3. Reporting at least \"moderate bother\" from SUI item on UDI \"Do you usually experience\r\n             urine leakage related to coughing, sneezing, or laughing\"\r\n\r\n          4. Diagnosis of SUI defined by a positive cough stress test (CST) or urodynamic\r\n             evaluation within the past 18 months\r\n\r\n          5. Desires surgical treatment for SUI symptoms\r\n\r\n          6. Urinary symptoms >3 months\r\n\r\n          7. Subjects understand that BPTx is a treatment option for MUI outside of ESTEEM study\r\n             protocol\r\n\r\n          8. Urodynamics within past 18 months\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Anterior or apical compartment prolapse at or beyond the hymen (>0 on POPQ),\r\n             regardless if patient is symptomatic\r\n\r\n             a)Women with anterior or apical prolapse above the hymen (<0) who do not report\r\n             vaginal bulge symptoms will be eligible\r\n\r\n          2. Planned concomitant surgery for anterior vaginal wall or apical prolapse > 0\r\n\r\n             a)Women undergoing only rectocele repair are eligible\r\n\r\n          3. Women undergoing hysterectomy for any indication will be excluded\r\n\r\n          4. Active pelvic organ malignancy\r\n\r\n          5. Age <21 years\r\n\r\n          6. Pregnant or plans for future pregnancy in next 12 months, or within 12 months\r\n             post-partum\r\n\r\n          7. Post-void residual >150 cc on 2 occasions, or current catheter use\r\n\r\n          8. Participation in other trial that may influence results of this study\r\n\r\n          9. Unevaluated hematuria\r\n\r\n         10. Prior sling, synthetic mesh for prolapse, implanted nerve stimulator for incontinence\r\n\r\n         11. Spinal cord injury or advanced/severe neurologic conditions including Multiple\r\n             Sclerosis, Parkinsons\r\n\r\n         12. Women on anti-muscarinic therapy will be eligible after 3 week wash-out period\r\n\r\n         13. Non-ambulatory\r\n\r\n         14. History of serious adverse reaction to synthetic mesh\r\n\r\n         15. Not able to complete study assessments per clinician judgment, or not available for 12\r\n             month follow-up\r\n\r\n         16. Women who only report \"other IE\" on bladder diary, and do not report at minimum 1\r\n             stress and 1 urge IE/3 days\r\n\r\n         17. Diagnosis of and/or history of bladder pain or chronic pelvic pain\r\n\r\n         18. Women who had intravesical Botox injection within the past 12 months\r\n      ","sponsor":"NICHD Pelvic Floor Disorders Network","sponsor_type":"Other","conditions":"Urinary Incontinence, Stress|Urinary Incontinence, Urge","interventions":[{"intervention_type":"Procedure","name":"Procedure: Miduretheral Sling","description":"MUS can include the TVT (mechanical cut mesh only, Gynecare, ETHICON Women's Health & Urology, Somerville, NJ), TVT-O (mechanical cut mesh only, Gynecare), or Monarc (American Medical Systems, Minnetonka, MN)."},{"intervention_type":"Other","name":"Other: Miduretheral Sling with behavioral/pelvic floor therapy","description":"MUS is combined with components of behavioral therapy (designed to change behaviors to encourage continence), and pelvic floor muscle therapy (designed to strengthen the pelvic floor muscles, enhance the physiological closure of the bladder neck, and improve coordination). This is done prior to MUS (1 visit) and after MUS for 5 visits at 2, 4, 6, 8 weeks and 6 months."}],"outcomes":[{"outcome_type":"primary","measure":"Change From Baseline UDI Total Score","time_frame":"3, 6, and 12 Months","description":"The Urogenital Distress Inventory (UDI) is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI scale has a range from 0 to 300 with higher scores indicating greater distress. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline UDI Stress Score","time_frame":"3, 6, and 12 Months","description":"The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI Stress subscale has a range from 0 to 100 with higher scores indicating greater distress. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline UDI Irritative Score","time_frame":"3, 6, and 12 Months","description":"The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI Irritative subscale has a range from 0 to 100 with higher scores indicating greater distress. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline UDI Obstructive Score","time_frame":"3, 6, and 12 Months","description":"The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI Obstructive subscale has a range from 0 to 100 with higher scores indicating greater distress. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline."},{"outcome_type":"other","measure":"Change From Baseline Number of Stress Incontinence Episodes","time_frame":"2 weeks and 2, 6, and 12 Months","description":"Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of stress incontinence episodes at 2 weeks, 2, 6, or 12 months and the number of stress incontinence episodes at baseline."},{"outcome_type":"other","measure":"Change From Baseline Number of Urge Incontinence Episodes","time_frame":"2 weeks and 2, 6, and 12 Months","description":"Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of urge incontinence episodes at 2 weeks, 2, 6, or 12 months and the number of urge incontinence episodes at baseline."},{"outcome_type":"other","measure":"Change From Baseline Number of Unknown Incontinence Episodes","time_frame":"2 weeks and 2, 6, and 12 Months","description":"Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of unknown incontinence episodes at 2 weeks, 2, 6, or 12 months and the number of unknown incontinence episodes at baseline."},{"outcome_type":"other","measure":"Change From Baseline Total Number of Incontinence Episodes","time_frame":"2 weeks and 2, 6, and 12 Months","description":"Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in total number of incontinence episodes at 2 weeks, 2, 6, or 12 months and the total number of incontinence episodes at baseline."},{"outcome_type":"other","measure":"Change From Baseline Number of Wet Pads Per Day","time_frame":"2 weeks and 2, 6, and 12 Months","description":"Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of wet pads per day at 2 weeks, 2, 6, or 12 months and the number of wet pads per day at baseline."},{"outcome_type":"other","measure":"Change From Baseline Number of Pads Per Day","time_frame":"2 weeks and 2, 6, and 12 Months","description":"Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in total number of pads per day at 2 weeks, 2, 6, or 12 months and the total number of pads per day at baseline."},{"outcome_type":"other","measure":"Change From Baseline Number of Daytime Voids","time_frame":"2 weeks and 2, 6, and 12 Months","description":"Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of daytime voids at 2 weeks, 2, 6, or 12 months and the number of daytime voids at baseline."},{"outcome_type":"other","measure":"Change From Baseline Number of Nighttime Voids","time_frame":"2 weeks and 2, 6, and 12 Months","description":"Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of nighttime voids at 2 weeks, 2, 6, or 12 months and the number of nighttime voids at baseline."},{"outcome_type":"other","measure":"Change From Baseline Number of Urgency Voids Without Incontinence","time_frame":"2 weeks and 2, 6, and 12 Months","description":"Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of urgency voids without incontinence at 2 weeks, 2, 6, or 12 months and the number of urgency voids without incontinence at baseline."},{"outcome_type":"other","measure":"Number of Participants With <8 Voids After Baseline (Normalization of Voiding Frequency)","time_frame":"2 weeks and 2, 6, and 12 Months","description":"Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, for participants with >8 voids at baseline, the outcome is calculated as Yes=no more than 8 voids noted at the time point, No=Otherwise"},{"outcome_type":"other","measure":"Number of Participants With 50% Reduction in Voids Relative to Baseline (Improved Voiding Frequency)","time_frame":"2 weeks and 2, 6, and 12 Months","description":"Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome is calculated as Yes=at least 50% reduction in the number of voids between 2 weeks, 2, 6, and 12 months and baseline, No=Otherwise"},{"outcome_type":"other","measure":"Number of Participants With Greater Number of Voids Relative to Baseline or >8 Voids (Worsening Voiding Frequency)","time_frame":"2 weeks and 2, 6, and 12 Months","description":"Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome is calculated as Yes=greater than baseline number of voids at the time point or with greater than 8 voids at the time point, No=Otherwise"},{"outcome_type":"other","measure":"Change From Baseline PISQ-IR NSAPR Score","time_frame":"3, 6, and 12 Months","description":"The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Not Partner Related subscale (NSA-PR) ranges from 0 to 100 with higher scores indicating worse function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline."},{"outcome_type":"other","measure":"PGI-S","time_frame":"Baseline 3, 6, and 12 Months","description":"The Patient Global Impression of Severity (PGI-S) is a patient-reported measure of perceived severity of condition, as assessed on a scale of 1 (Normal) to 4 (Severe). Included here are participants who reported Normal or Mild severity as indicated by a rating of 1 or 2."},{"outcome_type":"other","measure":"Change From Baseline PISQ-IR NSACS Score","time_frame":"3, 6, and 12 Months","description":"The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Not Sexually Active-Condition Specific subscale (NSA-CS) ranges from 0 to 100 with worse scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline."},{"outcome_type":"other","measure":"Change From Baseline PISQ-IR NSAGQR Score","time_frame":"3, 6, and 12 Months","description":"The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Not Sexually Active-Global Quality Rating subscale (NSA-GQR) ranges from 0 to 100 with higher scores indicating worse function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline."},{"outcome_type":"other","measure":"Change From Baseline PISQ-IR NSACI Score","time_frame":"3, 6, and 12 Months","description":"The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Not Sexually Active-Condition Impact subscale (NSA-CI) ranges from 0 to 100 with higher scores indicating worse function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline."},{"outcome_type":"other","measure":"Change From Baseline PISQ-IR SAAO Score","time_frame":"3, 6, and 12 Months","description":"The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Sexually Active-Arousal, Orgasm subscale (SA-AO) ranges from 0 to 100 with higher scores indicating worse function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline."},{"outcome_type":"other","measure":"Change From Baseline PISQ-IR SAPR Score","time_frame":"3, 6, and 12 Months","description":"The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Sexually Active-Partner Related subscale (SA-PR) ranges from 0 to 100 with higher scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline."},{"outcome_type":"other","measure":"Change From Baseline PISQ-IR SACS Score","time_frame":"3, 6, and 12 Months","description":"The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Sexually Active-Condition Specific subscale (SA-CS) ranges from 0 to 100 with higher scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline."},{"outcome_type":"other","measure":"Change From Baseline PISQ-IR SAGQR Score","time_frame":"3, 6, and 12 Months","description":"The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Sexually Active-Global Quality Rating subscale (SA-GQR) ranges from 0 to 100 with higher scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline."},{"outcome_type":"other","measure":"Change From Baseline PISQ-IR SACI Score","time_frame":"3, 6, and 12 Months","description":"The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Sexually Active-Condition Impact subscale (SA-CI) ranges from 0 to 100 with higher scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline."},{"outcome_type":"other","measure":"Change From Baseline PISQ-IR SAD Score","time_frame":"3, 6, and 12 Months","description":"The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Sexually Active-Desire subscale (SA-D) ranges from 0 to 100 with higher scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline."},{"outcome_type":"other","measure":"Change From Baseline EQ-5D Index Score","time_frame":"3, 6, and 12 Months","description":"EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life. The index score ranges from 0 to 1 with higher scores indicating a better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline."},{"outcome_type":"other","measure":"Change From Baseline EQ-5D Visual Analog Scale Score","time_frame":"3, 6, and 12 Months","description":"EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life. The visual analog scale (VAS) score ranges from 0 to 100 with higher scores indicating a better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline."},{"outcome_type":"other","measure":"Change From Baseline OABq-LF Symptom Severity Score","time_frame":"3, 6, and 12 Months","description":"The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Symptom Severity score ranges from 0 to 100 with higher score indicating worse quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline."},{"outcome_type":"other","measure":"Change From Baseline OABq-LF Coping Score","time_frame":"3, 6, and 12 Months","description":"The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Coping score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline."},{"outcome_type":"other","measure":"Change From Baseline OABq-LF Concern Score","time_frame":"3, 6, and 12 Months","description":"The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Concern score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline."},{"outcome_type":"other","measure":"Change From Baseline OABq-LF Sleep Score","time_frame":"3, 6, and 12 Months","description":"The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Sleep score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline."},{"outcome_type":"other","measure":"Change From Baseline OABq-LF Social Score","time_frame":"3, 6, and 12 Months","description":"The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Social score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline."},{"outcome_type":"other","measure":"Change From Baseline OABq-LF HRQL Total Score","time_frame":"3, 6, and 12 Months","description":"The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF HRQL score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline."},{"outcome_type":"other","measure":"OAB-SATq Satisfaction Score","time_frame":"3, 6, and 12 Months","description":"The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Satisfaction score ranges from 0 to 100 with higher scores indicating higher satisfaction."},{"outcome_type":"other","measure":"OAB-SATq Side Effect Score","time_frame":"3, 6, and 12 Months","description":"The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Side Effect score ranges from 0 to 100 with higher scores indicating fewer side effects."},{"outcome_type":"other","measure":"OAB-SATq Endorsement Score","time_frame":"3, 6, and 12 Months","description":"The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Endorsement score ranges from 0 to 100 with higher scores indicating greater endorsement."},{"outcome_type":"other","measure":"OAB-SATq Convenience Score","time_frame":"3, 6, and 12 Months","description":"The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Convenience score ranges from 0 to 100 with higher scores indicating greater convenience."},{"outcome_type":"other","measure":"OAB-SATq Preference Score","time_frame":"3, 6, and 12 Months","description":"The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The preference score is a binary [yes/no] indicator as to whether a subject indicated slight or definite preference for the treatment among women that have had previous treatment for overactive bladder. The outcome is the percentage of participants that prefer the current treatment to previous treatments."},{"outcome_type":"other","measure":"Change From Baseline IIq-LF Physical Activity Score","time_frame":"3, 6, and 12 Months","description":"The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Physical Activity score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline."},{"outcome_type":"other","measure":"Change From Baseline IIq-LF Travel Score","time_frame":"3, 6, and 12 Months","description":"The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Travel score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline."},{"outcome_type":"other","measure":"Change From Baseline IIq-LF Social Relationship Score","time_frame":"3, 6, and 12 Months","description":"The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Social Relationship score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline."},{"outcome_type":"other","measure":"Change From Baseline IIq-LF Emotional Health Score","time_frame":"3, 6, and 12 Months","description":"The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Emotional Health score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline."},{"outcome_type":"other","measure":"Change From Baseline IIq-LF Total Score","time_frame":"3, 6, and 12 Months","description":"The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Total score ranges from 0 to 400 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline."},{"outcome_type":"other","measure":"Change From Baseline ADI Hygiene Score","time_frame":"3, 6, and 12 Months","description":"The Adaptation Index is a standardized measure of health-related quality of life. The ADI Hygiene score ranges from 0 to 100 with higher score indicating worse severity in adaptive behaviors. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline."},{"outcome_type":"other","measure":"Change From Baseline ADI Avoidance Score","time_frame":"3, 6, and 12 Months","description":"The Adaptation Index is a standardized measure of health-related quality of life. The ADI Avoidance score ranges from 0 to 100 with higher score indicating worse severity in adaptive behaviors. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline."},{"outcome_type":"other","measure":"Change From Baseline Brink Score","time_frame":"2 weeks and 2 and 12 Months","description":"The Brink scale considers three pelvic floor muscle contraction variables: vaginal pressure or muscle force, elevation or vertical displacement of the examiner fingers, and duration of contraction. The score ranges from 3 to 12 with higher scores indicating greater PFM function. The change from baseline outcome is calculated as the difference in score at 3 or 12 months and the score at baseline."},{"outcome_type":"other","measure":"Change From Average Peak Muscle Contraction Pressure (cm H2O)","time_frame":"2 weeks and 2 and 12 Months","description":"The average peak muscle contraction is measured during a physical exam. The outcome is calculated as the difference in measured value at 3 or 12 months and the score at baseline."},{"outcome_type":"other","measure":"PGI-I","time_frame":"3, 6, and 12 Months","description":"The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had improvement as indicated by a rating of 1 (very much better), 2 (much better)."}]}
{"nct_id":"NCT02328391","start_date":"2013-09-30","enrollment":51,"brief_title":"STUDY OBSERVATIONAL OF ERLOTINIB AS SECOND LINE TREATMENT IN PATIENTS WITH SQUAMOUS NSCLC AND EGFR NATIVE","official_title":"MULTICENTER, PROSPECTIVE, OBSERVATIONAL OF ERLOTINIB AS SECOND-LINE TREATMENT IN PATIENTS WITH NON-SMALL CELL (NSCLC) LUNG CANCER WITH PREDOMINANTLY SQUAMOUS HISTOLOGY AND CARRIERS OF THE GENE (EGFR) EPIDERMAL GROWTH FACTOR RECEPTOR NATIVE","primary_completion_date":"2015-03-31","study_type":"Observational [Patient Registry]","rec_status":"Unknown status","completion_date":"2015-12-31","last_update":"2014-12-31","description":"OBJECTIVE study the effectiveness of the administration of Erlotinib 150 mg/Day v.o. in second-line treatment in patients with lung cancer advanced non-small of histology predominantly flaky by assessing the survival free of progression (SLP). Design Studio postautoritation of multicenter observational follow-up prospective (EPA-SP) type. DISEASE OTRASTORNO A study of cell Lung Cancer not small (NSCLC). MEDICATION object data to study the drug under study is erlotinib. -Dose and treatment guidelines follow the corresponding product sheet. Management of dosage and adverse effects specified in point H. 15 of the Protocol. POPULATION in study and number TOTAL of subjects population under study: adult patients with diagnosis of NSCLC with predominantly squamous histology total number of subjects: the participation of approximately 51 patients is expected DISEASE OR DISORDER TO STUDY Non Small Cell Lung Cancer (NSCLC). MEDICATION DATA OBJECT OF STUDY The drug under study is erlotinib. -Dose and treatment guidelines Follow the corresponding product sheet. Management of dosage and adverse effects specified in point H. 15 of the Protocol. STUDY POPULATION AND NUMBER TOTAL OF SUBJECTS Study: adult patients with diagnosis of NSCLC with predominantly squamous histology total number of subjects: the participation of approximately 51 patients is expected.","other_id":"GGC-ERL-2012-01","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Adult patients with diagnosis of NSCLC with predominantly squamous histology. The subject\r\n        shall be considered included in the study when, fulfilling the criteria of selection,\r\n        accept their participation therein by the signing of informed consent.","criteria":"\n        Inclusion Criteria:\r\n\r\n        - Age  18 years.\r\n\r\n          -  Histological or cytologic diagnosis of cancer (NSCLC) with predominantly squamous\r\n             histology stage IV non-small-cell lung.\r\n\r\n          -  ECOG performance status between 0 and 2.\r\n\r\n          -  Patients who have progressed to a first line of advanced disease and are eligible for\r\n             a second line with Erlotinib.\r\n\r\n          -  Patients that grant informed, preferably in writing, or oral consent before witnesses\r\n             independent of the research team.\r\n\r\n        Exclusion Criteria:\r\n\r\n        - Patients with uncontrolled or severe systemic disease, an active infection, neoplasia\r\n        concomitant or secondary neoplasia to primary disease, except for carcinoma in situ of\r\n        cervix or adequately treated skin carcinoma.\r\n\r\n          -  Disease with mutated EGFR, according to local laboratory. The determination of the\r\n             EGFR is not mandatory. Those patients from centers where there is the determination of\r\n             the EGFR or those patients that the EGFR is unknown may be included in.\r\n\r\n          -  Inability to take oral medication or previous surgical procedures that affect the\r\n             absorption and imply the need for intravenous or parenteral feeding.\r\n\r\n          -  Interstitial lung disease clinically active.\r\n\r\n          -  Unstable angina or recent myocardial infarction.\r\n\r\n          -  Brain metastasis uncontrolled and progressive.\r\n\r\n          -  Patients who are participating in a clinical trial.\r\n\r\n          -  Use of an inhibitor of tyrosine kinase in first line of treatment.\r\n\r\n          -  Patients whose estimated life expectancy does not reach the 2 months.\r\n\r\n          -  Any condition, situation which, in the opinion of the investigator, may endanger the\r\n             safety of the patient, or could interfere significantly with the involvement of the\r\n             subject in the study or evaluation of the results of the study.\r\n      ","sponsor":"Grupo Gallego de Cancer de Pulmon","sponsor_type":"Other","conditions":"Carcinoma, Squamous Cell","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Study the effectiveness of the administration of Erlotinib in 2nd line treatment in patients with advanced NSCLC scaly through assessment of the SLP","time_frame":"Collect the available information of the visits made by the patient according to the usual practice up to a max of 9 m after the inclusion of the last patient."},{"outcome_type":"secondary","measure":"Determination TR y TCE. • Determinar SG. • Identificar los diferentes factores pronósticos relacionados con la SLP y SG. • Determinar el perfil de seguridad del tratamiento.","time_frame":"Collect the available information of the visits made by the patient according to the usual practice up to a max of 9 m after the inclusion of the last patient."}]}
{"nct_id":"NCT02874417","start_date":"2013-09-30","phase":"N/A","enrollment":54,"brief_title":"Computerized Psychoeducation for Anxiety Sensitivity","primary_completion_date":"2014-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-11-30","last_update":"2016-08-22","description":"This investigation examines the efficacy of a 35 minute computerized psychoeducation protocol in the reduction of elevated anxiety sensitivity cognitive concerns, a risk factor for the development and maintenance of various forms of psychopathology.","other_id":"Norr01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Elevated Anxiety Sensitivity Cognitive Concerns and indicated by the anxiety\r\n             sensitivity index-3\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of epilepsy or seizures\r\n      ","sponsor":"Florida State University","sponsor_type":"Other","conditions":"Anxiety Sensitivity","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: CAST psychoeducation"},{"intervention_type":"Behavioral","name":"Behavioral: PHET"}],"outcomes":[{"outcome_type":"primary","measure":"Anxiety Sensitivity Index-3","time_frame":"10 minutes post intervention","description":"Measure of anxiety sensitivity"}]}
{"nct_id":"NCT01944605","start_date":"2013-09-30","enrollment":40,"brief_title":"Intestinal Ischemia as a Stimulus for Systemic Inflammatory Response After Cardiac Arrest","official_title":"Intestinal Ischemia as a Stimulus for Systemic Inflammatory Response After Cardiac Arrest","primary_completion_date":"2014-03-30","study_type":"Observational","rec_status":"Completed","completion_date":"2014-03-30","last_update":"2017-10-06","description":"Out-of-hospital cardiac arrest (CA) is a leading public health problem causing nearly one third of a million deaths annually in the US, accounting for half of all cardiovascular deaths and surpassing deaths from stroke, heart failure, and breast and lung cancer combined. Twenty to fifty percent of CA patients (pts) can be resuscitated initially but many die before hospital discharge or suffer permanent neurologic damage. Therapeutic hypothermia (TH) improves survival and neurological outcomes. Despite aggressive, targeted post arrest management, including TH, approximately 50% of pts die before leaving the hospital due to global ischemia-reperfusion injury (IRI) known as the \"post arrest syndrome\", 1 which is a sepsis-like state characterized by elevated markers of cellular inflammation and injury. It is believed that TH works by decreasing the body's basal metabolic rate (BMR) and attenuating the systemic inflammatory response (SIR). However, specific triggers of the intense pro-inflammatory response are unclear. This \"gap\" in knowledge must be closed to identify targeted therapy to decrease IRI and improve outcomes. Blood flow to the gut is decreased markedly and intestinal tissue becomes ischemic during CA and CPR, particularly when vasoconstrictor drugs such as epinephrine, are given. IRI of the intestine increases intestinal permeability leading to intestinal microbial translocation and endotoxin release that can stimulate and perpetuate systemic inflammation and cause subsequent multi-organ dysfunction. Endotoxin also increases body temperature and energy expenditure and may attenuate TH induced reductions in BMR and hence, decrease efficacy. The purpose of this novel pilot study is to detect systemic endotoxin release following CA in humans and determine association with cytokine activation, and BMR alterations during TH.","other_id":"HM15326","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"All adult patients resuscitated from Cardiac Arrest successfully and undergoing therapeutic\r\n        hypothermia will be evaluated for potential inclusion","criteria":"\n        Inclusion Criteria:\r\n\r\n        Adult, Cardiac Arrest with ROSC receiving Therapeutic Hypothermia-\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Age < 18\r\n\r\n          -  Cardiac Arrest of traumatic etiology\r\n\r\n          -  Known to be pregnant\r\n\r\n          -  Prisoner\r\n      ","sponsor":"Virginia Commonwealth University","sponsor_type":"Other","conditions":"Cardiac Arrest|Reperfusion Injury","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Detection of Endotoxin Activity","time_frame":"48 hours","description":"Endotoxin activity will be measured by the Endotoxin Activity Assay and values . of >0.4 EA units will be used as the \"cut-off\" for the presence of pathological endotoxin."},{"outcome_type":"secondary","measure":"Detection of sCD14","time_frame":"48 hours","description":"To demonstrate activation of endotoxin by the immune system and \"upstream\" physiologic changes necessary for systemic endotoxemia to occur"},{"outcome_type":"secondary","measure":"Detection of stool lactoferrin and stool α1-antitrypsin","time_frame":"48 hours","description":"To demonstrate evidence of intestinal inflammation and permeability that can lead to endotoxemia and \"downstream\" cellular inflammatory responses responsible for end organ damage"},{"outcome_type":"secondary","measure":"Detection and quantification of inflammatory cytokines","time_frame":"48 hours","description":"To demonstrate an association with the primary outcome"},{"outcome_type":"secondary","measure":"BMR measurement elevation","time_frame":"48 hours","description":"To determine its association with endotoxemia and cytokine. BMR is being measured to determine if pts with higher levels of endotoxin and cytokines have higher BMR and therefore blunted therapeutic value of TH"}]}
{"nct_id":"NCT01860287","start_date":"2013-09-30","phase":"Early Phase 1","enrollment":48,"brief_title":"The Effects of Buprenorphine on Responses to Verbal Tasks","official_title":"The Effects of Buprenorphine on Responses to Verbal Tasks","primary_completion_date":"2017-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-01-31","last_update":"2019-08-01","description":"In this study, the investigators will examine the effects of buprenorphine, as compared to placebo, upon physiological, subjective, and hormonal responses to a stressful speech task and a non-stressful control task in healthy adults. There is strong evidence in support of the role of endogenous opioids and opiates in mediating social behavior in humans and other animals, and particularly, in social distress. Recently it has been shown that buprenorphine, a partial mu-opioid agonist, reduces sensitivity to recognition of fearful facial expressions in humans. Here, the investigators propose to further explore the role of the opioid system in mediating stress responses in humans through the use of buprenorphine. The investigators hypothesize that buprenorphine with reduce both physiological and subjective measures of stress.","other_id":"UCIRB-130197","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy men and women\r\n\r\n          -  ages 18-40 years\r\n\r\n          -  high school education\r\n\r\n          -  fluent in English\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  history of adverse drug reactions\r\n\r\n          -  taking oral contraceptives or planning to become pregnant\r\n\r\n          -  taking any medications\r\n\r\n          -  smokers\r\n\r\n          -  night shift workers\r\n\r\n          -  drink more than 4 alcoholic or caffeinated drinks per day\r\n      ","sponsor":"University of Chicago","sponsor_type":"Other","conditions":"Basic Science","interventions":[{"intervention_type":"Drug","name":"Drug: Buprenorphine 0.2 MG Sublingual Tablet","description":"This is a within-subjects, double-blind, placebo-controlled experiment during which each participant will receive sublingual buprenorphine (0.2)"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"This is a within-subjects, double-blind, placebo-controlled experiment during which each participant will receive a placebo"},{"intervention_type":"Drug","name":"Drug: Buprenorphine 0.4 MG Sublingual Tablet","description":"This is a within-subjects, double-blind, placebo-controlled experiment during which each participant will receive sublingual buprenorphine (0.4)"}],"outcomes":[{"outcome_type":"primary","measure":"Subjective Effects as Assessed by Score on \"Feel Drug\", \"Feel High\", \"Like Drug\", and \"Want More\" Subscales of the Drug Effects Questionnaire Subjective Responses to Stress With and Without Buprenorphine","time_frame":"End of study - (Pre-administration of drug or placebo (Time 0), and approx 210 minutes after drug/placebo admin), End of study (210 min) shown","description":"The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: \"Feel Drug\", \"Feel High\", and \"Want More\". The \"Feel Drug\", \"Feel High\", \"Like Drug\", and \"Want More\" subscales are reported. All subscales are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0 -100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome."}]}
{"nct_id":"NCT02292056","start_date":"2013-09-30","phase":"N/A","enrollment":50,"brief_title":"Medication Safety and Contraceptive Counseling for Reproductive Aged Women With Psychiatric Conditions","official_title":"Medication Safety and Contraceptive Counseling for Reproductive Aged Women With Psychiatric Conditions","primary_completion_date":"2015-10-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2015-10-31","last_update":"2014-11-17","description":"There is currently limited research that addresses the unique medication safety and family planning needs among women of reproductive age with psychiatric conditions. The study will research the feasibility of a novel individualized 1-on-1 counseling session at the Gifford Clinic in the Department of Psychiatry at UCSD that will help women in this population better understand: 1) which of their medications are safe to use in pregnancy, 2) provide education regarding the importance of using contraception and which contraceptive choices are available to them, and 3) raise awareness of any drug-drug interactions that may exist between their medications and their chosen method of contraception. Patients will be given questionnaire to assess their contraceptive utilization. They will also be given a before and after quiz to allow for an objective measure of the patient's increase in knowledge regarding medication safety and contraceptive choices as a result of the investigators intervention.","other_id":"131088","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Presenting for follow up psychiatric visit\r\n\r\n          -  Ethnic Background: will include only english speaking participants (MotherToBaby\r\n             counselors are only able to speak English)\r\n\r\n          -  Level of Education: No limitation\r\n\r\n          -  Health Status: at least one psychiatric condition for which they are taking medication\r\n\r\n          -  Sexually active with Men\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Planning to become pregnant\r\n\r\n          -  Not sexually active with men\r\n\r\n          -  History of hysterectomy, bilateral oophorectomy, or surgical sterilization\r\n\r\n          -  Decisionally impaired - using post-consent instrument to assess decisional capacity.\r\n             If a potential participant does not score 100% on post-consent instrument, then she\r\n             will be excluded from participation.\r\n      ","sponsor":"University of California, San Diego","sponsor_type":"Other","conditions":"Mental Disorders|Contraception|Chemical Teratogen Exposure","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: 1-on-1 counseling","description":"Precounseling questionnaire collecting demographic information, contraception information, and reasons for choosing contraceptive method\r\nPrecounseling quiz: assess baseline level of knowledge regarding medication safety and contraceptive option.\r\nCounseling: completed by MotherToBaby counselor about the safety of their medications for use in pregnancy.\r\n10 minute video entitled \"The Contraceptive Choice Project: Which Birth Control Method is Right for You?\" by Washington University in St. Louis.\r\nPost-Counseling Quiz to assess whether specialized training impacted their understanding of medication safety and contraceptive options.\r\nPost-Counseling Questionnaire: assess contraceptive plans and satisfaction with counseling"}],"outcomes":[{"outcome_type":"primary","measure":"Increase in Patient Knowledge","time_frame":"1 year","description":"Assessed with score delta between Pre-counseling and Post-counseling Quizzes"},{"outcome_type":"secondary","measure":"Contraceptive Plans","time_frame":"1 year","description":"Captured in Post-Counseling questionnaire"},{"outcome_type":"secondary","measure":"Utilization of Contraception","time_frame":"1 year","description":"Captured in Pre-Counseling questionnaire"},{"outcome_type":"secondary","measure":"Baseline Medication Safety Knowledge","time_frame":"1 year","description":"Captured in Pre-Counseling questionnaire"}]}
{"nct_id":"NCT01916694","start_date":"2013-09-30","phase":"N/A","enrollment":203,"brief_title":"Trial of Remote Evaluation and Treatment of Gestational Diabetes Mellitus","official_title":"A Randomised Pilot Trial to Compare Remote Blood Glucose Monitoring With Standard Clinical Care in the Gestational Diabetic Population","primary_completion_date":"2016-02-29","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-02-29","last_update":"2016-05-20","description":"Diabetes in pregnancy (gestational diabetes) is becoming more common. It can lead to problems for both mothers-to-be and their babies such as causing a large baby and difficult birth. Gestational diabetes in the mother may also lead to effects on the long term health of the baby. Most people today use mobile phones. Our research is looking at using a mobile phone app to help with diabetes care in pregnancy. In particular, the investigators are using phones which connect to the standard blood glucose monitoring machines given to all women with gestational diabetes to see if sending the hospital team blood test results between clinic appointments can result in the need for fewer clinic visits. The investigators are also testing to see how acceptable using mobile phones in this way, is to our patients and that the control of the blood glucose and outcomes for the mother and baby are at least as good as standard care. The investigators are planning to recruit 200 women who receive care for their gestational diabetes at the Oxford University Hospitals NHS (National Health Service) Trust. They will be randomised so that 100 will receive standard care, and 100 will have a mobile phone \"app\" linked to the blood glucose machines to send blood glucose readings directly to the diabetes care team to review. Both groups will be asked to test their blood glucose levels at home regularly with a glucometer. All participants will also be given lifestyle advice to reduce the chance they will need medication. Blood glucose control will be measured also by the percentage of glycated hemoglobin (HbA1c) at the time of diagnosis of gestational diabetes and before delivery.","other_id":"13/SC/0176","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"Single","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Pregnant women with an abnormal 75 gram 2 hour glucose tolerance test as defined by\r\n             the IADPSG (International Association of Diabetes in Pregnancy Study Group)\r\n\r\n          -  Willingness and able to give informed consent\r\n\r\n          -  Female aged between 18-40 years\r\n\r\n          -  Singleton pregnancy\r\n\r\n          -  Able to travel to hospital independently\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Impaired cognitive function such that she is unable to operate m-health equipment\r\n\r\n          -  Any evidence of fetal compromise\r\n\r\n          -  Known risk factors for obstetric complications, other than obesity and diabetes\r\n\r\n          -  Gestational diabetes requiring immediate pharmacologic treatment\r\n\r\n          -  Twins or higher order pregnancy\r\n\r\n          -  OGTT (Oral Glucose Tolerance Test) suggesting preexisting diabetes (fasting blood\r\n             glucose >= 7.0 or 2 hour >= 11.1 mmol/L\r\n\r\n          -  Gestation greater than 34+6 at the time of potential recruitment\r\n\r\n          -  Unable to speak English well enough to explain or use equipment\r\n      ","sponsor":"University of Oxford","sponsor_type":"Other","conditions":"Gestational Diabetes Mellitus|Pregnancy","interventions":[{"intervention_type":"Device","name":"Device: Blue tooth enabled glucose meter with smart phone application"},{"intervention_type":"Behavioral","name":"Behavioral: Self home blood glucose monitoring","description":"Fingerprick testing of blood glucose levels before and 2 hours after meals"}],"outcomes":[{"outcome_type":"primary","measure":"Glycosylated haemogloblin","time_frame":"8 weeks from recruitment at 28 weeks gestation to 36 weeks gestation","description":"Glycosylated haemoglobin (HbA1C) will be measured at the time of recruitment (around 28 weeks gestation) and at 36 weeks gestation. This will be approximately 8 weeks after recruitment (time 0)."},{"outcome_type":"secondary","measure":"Mean Blood glucose levels for fasting, pre-prandial and post-prandial readings","time_frame":"10 weeks (from 28 weeks gestation to 38 weeks gestation)","description":"Mean blood glucose levels for all readings measured fasting, pre-prandial and post prandial will be calculated over the 10 week participation in the trial (from recruitment at 28 weeks gestation to delivery at 38 weeks gestation)."},{"outcome_type":"secondary","measure":"Percentage of 'on target' blood glucose readings","time_frame":"8 weeks (from recruitment at 28 weeks gestation to 36 weeks gestation)","description":"Fasting readings as defined >=3.5 and <=5.8 mmol/L and post prandial readings >= 3.5 and <= 7.7 mmol/L for the first four weeks after randomisation and the second four weeks after randomisation"},{"outcome_type":"secondary","measure":"Effectiveness of monitoring","time_frame":"10 weeks (from 28 weeks gestation to 38 weeks gestation)","description":"Time to first trigger point (intensive dietary and lifestyle advice and increase monitoring to 7 days home per week) Time to second trigger point (insulin or metformin therapy) Time to treatment Number of changes to hypoglycaemics Maximum dose of insulin and metformin"},{"outcome_type":"secondary","measure":"Maternal outcomes","time_frame":"Approximately 11 weeks after recruitment","description":"Perineal trauma (defined as third or fourth degree tear), pregnancy induced hypertension and preeclampsia, admission to higher level of care for mother. This will be measured up to 7 days post delivery (if birth is at 38 weeks, this will be 11 weeks after trial recruitment, unless birth occurs earlier)"},{"outcome_type":"secondary","measure":"Maternal weight gain,","time_frame":"10 weeks (from 28 weeks gestation to 38 weeks gestation)","description":"Weight gain in kilograms from trial recruitment until last antenatal visit prior to delivery"},{"outcome_type":"secondary","measure":"Birthweight","time_frame":"At birth (approximately 10 weeks after trial recruitment)","description":"Z score of weight in kilograms for gestational age at delivery and Birthweight greater than 4.5kg"},{"outcome_type":"secondary","measure":"Birth injury","time_frame":"At birth (approximately 10 weeks after trial recruitment)","description":"Fracture of clavicle or humerus or other injury attributed to difficult birth, such as Erbs palsy or skull fracture"},{"outcome_type":"secondary","measure":"Neonatal hypoglycaemia","time_frame":"Approximately 10.5 weeks after recruitment","description":"Documented blood glucose level <2.5mmol/L or requiring parenteral feeding within the first 48 hours of life after birth at around 38 weeks gestation (birth at approximately 10 weeks following trial recruitment and blood glucose monitoring in the neonate up to 48 hours after this)"},{"outcome_type":"other","measure":"Economic evaluation","time_frame":"11 weeks from trial recruitment","description":"Direct cost of clinical care provision including outpatient appointments, emergency presentations, inpatient admission nights, neonatal intensive and special care admission nights, cost of phone and blue tooth equipment, time spent on computer system by clinical staff, other associated treatment and obstetric management costs, costs associated with co-morbid conditions"}]}
{"nct_id":"NCT02128126","start_date":"2013-09-30","phase":"Phase 1/Phase 2","enrollment":93,"brief_title":"Study of the Therapeutic Vaccine (ISA101/ISA101b) to Treat Advanced or Recurrent Cervical Cancer","official_title":"A Multicenter, Open Label Phase I/II Study to Determine the Safety and Immune Modulating Effects of the Therapeutic Human Papilloma Virus 16 (HPV16) E6/E7 Long Peptides Vaccine (ISA101/ISA101b) Immunotherapy in Combination With Standard of Care Therapy (Carboplatin and Paclitaxel With or Without Bevacizumab) in Women With HPV16 Positive Advanced or Recurrent Cervical Cancer Who Have no Curative Treatment Options","primary_completion_date":"2018-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-08-31","last_update":"2019-03-06","description":"The purpose of the study is to assess the safety, tolerability and the HPV-specific immune responses of different doses of ISA101 vaccine with or without pegylated IFN as combination therapy with carboplatin and paclitaxel. To qualitatively assess the safety profile and the HPV-specific immune responses of ISA101b vaccine compared to ISA101 at the same dose levels. To assess the safety and the HPV-specific immune responses of ISA101b vaccine with carboplatin, paclitaxel with or without bevacizumab.","other_id":"ISA-HPV-01-12","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Women  18 years of age.\r\n\r\n          2. Cervical cancer confirmed by histology.\r\n\r\n          3. Advanced or metastatic or recurrent cervical cancer confirmed by clinical and/or\r\n             radiological proof with no curative treatment options.\r\n\r\n          4. For cohort 10 (and 12), i.e. patients eligible to receive bevacizumab at each site per\r\n             standard of care, patients may be primary stage IVB (including persistent) or first\r\n             recurrent carcinoma of the uterine cervix (squamous cell carcinoma, adenocarcinoma, or\r\n             adenosquamous carcinoma). Prior treatment with chemotherapy for recurrent disease is\r\n             not permitted. However, one prior line of chemotherapy with platinum during primary\r\n             radio-chemotherapy or platinum-base chemotherapy as neoadjuvant chemotherapy prior to\r\n             surgery is permitted\r\n\r\n          5. Tumour must be HPV16 positive.\r\n\r\n          6. Patients should be eligible for chemotherapy with carboplatin and paclitaxel, and have\r\n             consented with chemotherapy with carboplatin and paclitaxel, before the start of the\r\n             informed consent procedure for the study.\r\n\r\n          7. Performance status (WHO scale/ECOG) 1.\r\n\r\n          8. Written informed consent according to local guidelines.\r\n\r\n          9. Written approval by the treating physician/investigator of his/her clinical judgment\r\n             that the patient has a reasonable life expectancy and is sufficiently fit and\r\n             motivated to complete the study treatment and comply to all study procedures conform\r\n             the protocol.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Treatment:\r\n\r\n          1. Prior treatment with anti-HPV agents.\r\n\r\n          2. Chronic systemic steroid use. Local application (i.e. stable doses of topical or\r\n             inhaled corticosteroids) is allowed.\r\n\r\n          3. Less than 4 weeks since the last treatment with other cancer therapies, (i.e.\r\n             endocrine therapy, immunotherapy, radiotherapy, chemotherapy, etc), less than 8 weeks\r\n             for cranial radiotherapy, and less than 6 weeks for nitrosoureas and mitomycin C.\r\n\r\n          4. Toxicities resulting from previous anti-cancer therapy must be resolved to  grade 2.\r\n\r\n          5. Recent treatment (within 30 days of first study treatment) with another\r\n             investigational drug.\r\n\r\n          6. Patients with known hypersensitivity to any component of the Investigational Medicinal\r\n             Product.\r\n\r\n          7. Any contraindication to the use of authorized applied products (i.e. paclitaxel,\r\n             carboplatin or bevacizumab).\r\n\r\n             Haematology and biochemistry:\r\n\r\n          8. Inadequate bone marrow function: Absolute Neutrophil Count (ANC) < 1.5 x 109/L, or\r\n             platelet count < 100 x 109/L or hemoglobin < 6 mmol/L.\r\n\r\n          9. Inadequate liver function, defined as:\r\n\r\n               -  Serum (total) bilirubin > 2 x upper normal limit (ULN);\r\n\r\n               -  Aspartate Aminotransferase (ASAT) or Alanine Aminotransferase (ALAT) > 2.5 x ULN\r\n                  (> 5 x ULN in patients with liver metastases);\r\n\r\n               -  Alkaline phosphatase levels > 2.5 x ULN (> 5 x ULN in patients with liver\r\n                  metastases, or > 10 x ULN in patients with bone metastases).\r\n\r\n             Other:\r\n\r\n         10. Clinical suspicion or radiological evidence of brain or leptomeningeal metastases.\r\n\r\n         11. Previous or current malignancies at other sites, with the exception of basal or\r\n             squamous cell carcinoma of the skin and with the exception of other malignancies from\r\n             which the patient may be considered cured as evidenced by complete regression of all\r\n             lesions >10 years ago.\r\n\r\n         12. Active HIV, chronic hepatitis B or C infection.\r\n\r\n         13. Patients of childbearing potential not willing to consistently and correctly us a\r\n             contraceptive method according to ICH (M3) resulting in low failure rate, i.e. less\r\n             that 1% per year such as oral contraceptives or use of effective means of\r\n             contraception.\r\n\r\n         14. Pregnancy or lactation. Serum pregnancy test to be performed within 7 days prior to\r\n             study treatment start in patients of childbearing potential.\r\n\r\n         15. Major surgical procedure within 28 days prior to the first study treatment.\r\n\r\n         16. Uncontrolled sustained hypertension (systolic > 180 mm Hg and/or diastolic > 110mm\r\n             Hg).\r\n\r\n         17. Clinically significant (i.e. active) cardiovascular disease defined as:\r\n\r\n               -  Stroke within  6 months prior to day 1;\r\n\r\n               -  Transient Ischemic Attack (TIA) within  6 months prior to day 1;\r\n\r\n               -  Myocardial infarction within  6 months prior to day 1;\r\n\r\n               -  Unstable angina;\r\n\r\n               -  New York Heart Association (NYHA) Grade II or greater Congestive Heart Failure\r\n                  (CHF);\r\n\r\n               -  Serious cardiac arrhythmia requiring medication;\r\n\r\n         18. History of severe bronchial asthma and/or severe allergy.\r\n\r\n         19. Evidence of any other medical conditions that may interfere with the planned\r\n             treatment, affect patient compliance or place the patient at high risk from\r\n             treatment-related complications.\r\n      ","sponsor":"ISA Pharmaceuticals","sponsor_type":"Industry","conditions":"Cervical Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: ISA101/ISA101b","description":"Four dose levels ISA101/ISA101b"}],"outcomes":[{"outcome_type":"primary","measure":"HPV-specific immune responses","time_frame":"4 months","description":"HPV-specific immune responses to different doses of the ISA101 vaccine with or without pegylated interferon alpha (INFα) as combination therapy with carboplatin and paclitaxel will be determined. The HPV-specific immune responses to ISA101b will be qualitatively compared to the responses at the same dose level(s) of ISA101."},{"outcome_type":"secondary","measure":"Evaluate the clinical efficacy by antitumor efficacy according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1","time_frame":"one year"},{"outcome_type":"other","measure":"Evaluate the general responsiveness of the immune system as measured by explorative assays.","time_frame":"4 months","description":"General responsiveness of the immune system as measured by explorative assays in particular:\r\nLymphocyte proliferation\r\nAntigen Presenting Cell (APC) function tests\r\nAssay of myeloid and lymphoid cell composition\r\nRecall proliferative responses of Peripheral Blood Mononuclear Cells(PBMCs) in response to common microbial antigens"}]}
{"nct_id":"NCT01964443","start_date":"2013-09-30","enrollment":719,"brief_title":"Clinical Assessment and Psychosocial Impact of Psoriasis","official_title":"EPidemiological Study In Patients With Recently DiagnosEd PSOriasis: Clinical Assessment and Psychosocial Impact of This Disease","primary_completion_date":"2015-11-30","study_type":"Observational","rec_status":"Completed","completion_date":"2015-11-30","last_update":"2015-12-15","description":"The purpose of this study is to explore the impact of plaque psoriasis on the different dimensions of patient life including psychological disorders, different types of addictions, and their consequences on health-related quality of life and socioeconomic parameters at baseline (cross-sectional part) and during the initial years of the psoriasis disease (longitudinal part).","other_id":"CR100972","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"Men and women, 18 years of age and older, who have had the onset of the first symptoms of\r\n        plaque psoriasis less than 10 years before study entry, are nave or experienced to topical\r\n        treatment, and are eligible for phototherapy or systemic treatment","criteria":"\n        Inclusion Criteria:\r\n\r\n        Have onset of first symptoms of plaque psoriasis less than 10 years before baseline; Be\r\n        either nave or experienced to topical treatment; Be eligible for phototherapy or systemic\r\n        treatment, as determined by the participating physician at the patient's baseline visit.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Has a history of or current treatment with a systemic agent (including biologic agents);\r\n        Has non-plaque forms of psoriasis (eg, erythrodermic, guttate, or pustular); Has received\r\n        an investigational drug (including investigational vaccines) or used an invasive\r\n        investigational medical device within 30 days before the start of the study or first data\r\n        collection time point.\r\n      ","sponsor":"Janssen Pharmaceutica N.V., Belgium","sponsor_type":"Industry","conditions":"Psoriasis","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"prevalence of alexithymia","time_frame":"Baseline","description":"presence of alexithymia defined as 20-item Toronto Alexithymia Scale (TAS-20) score ≥61: TAS-20 is a validated self-report scale that is comprised of 20 items. Items are rated using a 5-point Likert scale: 1 = strongly disagree, 2 = neither agree or disagree, 3 = undecided, 4 = agree, 5 = strongly agree. There are 3 subscales: difficulty describing feelings, difficulty identifying feelings, and externally oriented thinking. The total alexithymia score is the sum of responses to all 20 items, while the score for each subscale factor is the sum of the responses to that subscale. The TAS-20 uses cutoff scoring: equal to or less than 51 = non-alexithymia, equal to or greater than 61 = alexithymia. Scores of 52 to 60 = possible alexithymia."},{"outcome_type":"secondary","measure":"psoriasis disease duration","time_frame":"baseline, month 6 and month 12","description":"Psoriasis Global Assessment (PGA): Overall lesions are graded for induration (from 0 = no evidence of plaque elevation to 5 = severe plaque elevation = 1.25 mm or more), erythema (from 0 = no evidence of erythema, hyperpigmentation may be present to 5 = dusky to deep red coloration), and scaling (from 0 = no evidence of scaling to 5 = severe; very thick tenacious scale predominates). The sum of the 3 scales is divided by 3 and rounded to obtain a final PGA score. The PGA final scores are defined as: 0 = cleared, except for residual discoloration; 1 = minimal; 2 = mild; 3 = moderate; 4 = marked; and 5 = severe."},{"outcome_type":"secondary","measure":"psoriasis disease severity","time_frame":"baseline, month 6 and month 12","description":"Psoriasis Area and Severity Index (PASI): system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72. A PASI 50 response is defined as ≥50% improvement in PASI score from baseline; PASI 75 and PASI 90 are similarly defined."},{"outcome_type":"secondary","measure":"anxiety and depression","time_frame":"baseline, month 6 and month 12","description":"Hospital Anxiety and Depression Scale (HADS; subscales: anxiety [-A], depression [-D]) is a validated 14-item scale with 7 of the items relating to anxiety and 7 relating to depression. Each item is scored from 0 to 3, with higher scores indicating greater likelihood of depression or anxiety. Cases of anxiety or depression are each defined by subscale scores of 8 or greater, and categorized as normal (score of 0 to 7), mild (score of 8 to 10), moderate (score of 11 to 14), and severe (score of 15 to 21). The recall period is the past week."},{"outcome_type":"secondary","measure":"problematic drinking","time_frame":"baseline, month 6 and month 12","description":"Alcohol Use Disorders Identification Test (AUDIT) consists of 10 questions about a patient's quantity and frequency of alcohol use. The response to 8 of the questions are scored as 0 = never, 1 = monthly or less, 2 = 2 to 4 times a month, 3 = 2 to 3 times a week, 4 = 4 or more times a week. Two questions are scored as 0 = no, 2 = yes, but not in the last year, 4 = yes, during the last year. A score of 8 or more is associated with harmful or hazardous drinking. In this study, the patient self-report questionnaire will be used"},{"outcome_type":"secondary","measure":"smoking","time_frame":"baseline, month 6 and month 12","description":"number of cigarettes smoked per day"},{"outcome_type":"secondary","measure":"physical and mental/emotional quality of life","time_frame":"baseline, month 6 and month 12","description":"Dermatology Life Quality Index (DLQI) is a dermatology-specific validated 10-question quality of life instrument. Each question addresses how much the patient's skin problem has affected their life and is scored as: 3 = very much, 2 = a lot, 1 = a little, 0 = not at all, or 0 = not relevant. The recall period is the past week. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more health-related quality of life is impaired: 0 to 1 = no effect at all on patient's life; 2 to 5 = small effect on patient's life; 6 to 10 = moderate effect on patient's life; 11 to 20 = very large effect on patient's life; 21 to 30 = extremely large effect on patient's life."},{"outcome_type":"secondary","measure":"work and activity impairment related to psoriasis","time_frame":"baseline, month 6 and month 12","description":"Work Productivity and Activity Impairment questionnaire:Psoriasis (WPAI:PSO) produces 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and activity impairment. The WPAI:PSO outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, ie, worse outcomes."},{"outcome_type":"secondary","measure":"alexithymia prevalence rate","time_frame":"month 6 and month 12"}]}
{"nct_id":"NCT01809288","start_date":"2013-09-26","enrollment":146,"brief_title":"Identifying Risk for Diabetes and Heart Disease in Women","official_title":"Identifying Risk for Diabetes and Heart Disease in Women: A Study of African-American, African and White Federal Employees and Contractors","primary_completion_date":"2018-10-16","study_type":"Observational","rec_status":"Completed","completion_date":"2018-10-16","last_update":"2021-08-13","description":"Background: - Rates of diabetes and heart disease in women are increasing. Early recognition of risk could help women live longer and healthier lives. Race and ethnicity may affect the best kinds of tests to use to screen for these conditions. Researchers want to compare risk factors for diabetes and heart disease in African, African-American, and white women. Doing so may help identify the most effective screening test for each group. This study will look at healthy African, African-American, and white women who are federal employees and contractors. Objectives: - To study risk factors for diabetes and heart disease in African, African-American, and white women. Eligibility: - Healthy African, African-American, and white women between 30 and 65 years of age who are federal employees or contractors. - For this study, African women must be born in Africa and have immigrated to the United States, and report that both parents are Africans. African-American women must self-identify as African-Americans, born in the United States, and have parents who both self-identify as African-American born in the United States. White women must self-identify as white and have parents who also self-identify as white. Design: - Participants will have four visits to study their risk factors for diabetes and heart disease. - The first visit is a screening visit. Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. They will also have an EKG test. Participants will also be shown how to fill out a 3-Day Food Record and wear an activity monitor called an accelerometer. The food record will keep track of how much participants eat for 3 consecutive days, including 1 non-working day. The accelerometer device will be worn for 3 days to monitor movement. - At the second visit, participants will have blood tests, an oral glucose tolerance test, and body fat measurements. They will also fill out questionnaires, review the food record, and have two imaging studies. - At the third visit, participants will have a longer glucose tolerance test. During the test, participants will receive both glucose and insulin and blood samples will be collected over several hours. Participants will receive lunch at the clinical center after the test. - At the fourth visit, participants will have a meal test. They will fast for 12 hours before the test. Participants will eat a specific meal and have blood samples taken during and after they eat. - Participants will discuss the results of these tests with the study doctors.","other_id":"130090","observational_model":"Cohort","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"Female","minimum_age":25,"maximum_age":65,"population":"Women-Federal Employees and Contractors@@@@@@","criteria":"\n        -  INCLUSION CRITERIA FOR PRIMARY PROTOCOL:\r\n\r\n          -  African, African-American and White Women\r\n\r\n          -  Healthy Volunteers\r\n\r\n          -  Age between 25 and 65 years\r\n\r\n          -  BMI between 20 and 45 kg/m(2)\r\n\r\n          -  Federal Employees-Intramural or Extramural or Contractor\r\n\r\n        INCLUSION CRITERIA FOR NESTED INPATIENT STUDY\r\n\r\n        Same as primary outpatient protocol except:\r\n\r\n          -  Age restricted to 25 to 50 years\r\n\r\n          -  BMI restricted to 25 and 45 kg/m2\r\n\r\n          -  Premenopausal status\r\n\r\n        EXCLUSION CRITERIA:\r\n\r\n          -  Pregnancy\r\n\r\n          -  Medications or Medical Conditions which affect parameters under investigation\r\n      ","sponsor":"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","sponsor_type":"NIH","conditions":"Obesity|Insulin Resistance|Triglycerides|Diabetes","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Determine if there are differences in African, African-American and white women in the relationship between triglyceride levels, (a frequently used screening test for diabetes and heart disease) glucose tolerance status and insulin resistance.","time_frame":"2-6 weeks","description":"Triglyceride concentration and insulin resistance measured by the frequently sampled intravenous glucose tolerance test."},{"outcome_type":"secondary","measure":"Determine if there are race or ethnic differences in the pancreatic secretion of insulin relative to the degree of insulin resistance.","time_frame":"2-6 weeks","description":"Insulin secretion measured by frequently sampled intravenous glucose tolerance test."}]}
{"nct_id":"NCT01881867","start_date":"2013-09-10","phase":"Phase 2","enrollment":54,"brief_title":"CYT107 After Vaccine Treatment (Provenge) in Patients With Metastatic Castration-Resistant Prostate Cancer","official_title":"Phase 2 Study of Recombinant Glycosylated Human Interleukin-7 (CYT107) After Completion of Standard Therapy With Sipuleucel-T (Provenge) in Pts w/ Asymptomatic or Minimally Symptomatic Metastatic Castration-Resistant Prostate Cancer(mCRPC)","primary_completion_date":"2017-05-15","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-01-02","last_update":"2019-07-09","description":"This randomized phase II trial studies how well glycosylated recombinant human interleukin-7 (CYT107) after vaccine therapy works in treating patients with castration-resistant prostate cancer that has spread to other areas of the body or has not responded to at least one type of treatment. Biological therapies, such as glycosylated recombinant human interleukin-7, may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines made from white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells. It is not yet known whether glycosylated recombinant human interleukin-7 works better with or without vaccine therapy in treating prostate cancer.","other_id":"CITN12-03","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer\r\n             (mCRPC)\r\n\r\n          -  Patients must have successfully completed therapy with sipuleucel-T within 3-7 days of\r\n             planned CYT107 study drug treatment\r\n\r\n          -  Assessable disease with a positive bone scan and/or measurable disease on computed\r\n             tomography (CT) scan and/or magnetic resonance imaging (MRI) of the abdomen and pelvis\r\n\r\n          -  Prior orchiectomy or must be on ongoing luteinizing hormone-releasing hormone (LHRH)\r\n             agonist or antagonist (e.g., degarelix) therapy\r\n\r\n          -  No ongoing anti-androgen therapy; patients must be off anti-androgen therapy for at\r\n             least 30 days\r\n\r\n          -  Patients receiving any other hormonal therapy, including any dose of megestrol acetate\r\n             (Megace), Proscar (finasteride), any herbal product known to decrease prostate\r\n             specific antigen (PSA) levels (e.g. saw palmetto, PC-SPES), or any systemic\r\n             corticosteroid, must discontinue the agent for at least 30 days prior to study\r\n             treatment\r\n\r\n          -  Absolute neutrophil count (ANC) >= 1500/uL\r\n\r\n          -  Bilirubin < 1.5 x upper limit of normal (ULN)\r\n\r\n          -  Hemoglobin >= 10 g/dL\r\n\r\n          -  Platelets >= 100,000/mcL\r\n\r\n          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN\r\n\r\n          -  Creatinine clearance >= 60 mL/min by the Cockcroft-Gault equation\r\n\r\n          -  Testosterone =< 50 ng/dL (documented at any time while on LHRH agonist or antagonists\r\n             or s/p orchiectomy)\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 or a Karnofsky\r\n             performance status of >= 80%\r\n\r\n          -  Life expectancy of at least 6 months\r\n\r\n          -  Prior local radiation therapy must be completed at least 30 days prior to enrollment\r\n             and the patient must have recovered from all toxicity\r\n\r\n          -  Prior \"systemic\" radiopharmaceuticals (strontium, samarium, radium 223 dichloride)\r\n             must be completed >= 8 weeks prior to enrollment\r\n\r\n          -  Patients must agree to use 2 methods of adequate contraception for the duration of\r\n             study participation, and for four months after discontinuing therapy\r\n\r\n          -  Ability to understand and the willingness to sign a written informed consent document\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior chemotherapy for castration resistant prostate cancer; neoadjuvant chemotherapy\r\n             and chemotherapy given for hormone sensitive prostate cancer are allowed\r\n\r\n          -  Prior investigational immunotherapy\r\n\r\n          -  Prostate cancer pain requiring regularly scheduled narcotics\r\n\r\n          -  Pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical\r\n             erosion on radiography > 50%) or spinal cord compression\r\n\r\n          -  Current treatment with systemic steroid therapy (inhaled/topical steroids are\r\n             acceptable); systemic corticosteroids must be discontinued for at least 30 days prior\r\n             to first CYT107 injection\r\n\r\n          -  Known central nervous system metastases\r\n\r\n          -  Documented cirrhosis or documented acute hepatitis; Note: a positive hepatitis B\r\n             serology indicative of previous immunization (i.e., hepatitis B surface antibody\r\n             [HBsAb] positive and hepatitis B core antibody [HBcAb] negative), or a fully resolved\r\n             acute hepatitis B virus (HBV) infection is not an exclusion criterion\r\n\r\n          -  History of severe asthma, as defined by prior or current use of systemic\r\n             corticosteroids for disease control, with the exception of physiological replacement\r\n             doses of cortisone acetate or equivalent, as defined by a dose of 10 mg or less\r\n\r\n          -  Medical or psychiatric illness that would, in the opinion of the investigator,\r\n             preclude participation in the study or the ability of patients to provide informed\r\n             consent for themselves\r\n\r\n          -  Cardiovascular disease that meets one of the following: congestive heart failure (New\r\n             York Heart Association class III or IV), active angina pectoris, or recent myocardial\r\n             infarction (within the last 6 months)\r\n\r\n          -  Concurrent or prior malignancy except for the following:\r\n\r\n               -  Adequately treated basal or squamous cell skin cancer\r\n\r\n               -  Adequately treated stage I or II cancer from which the patient is currently in\r\n                  complete remission\r\n\r\n               -  Any other cancer from which the patient has been disease-free for 5 years\r\n\r\n          -  Known human immunodeficiency virus (HIV) or other history of immunodeficiency\r\n             disorder; HIV-positive patients on combination antiretroviral therapy are ineligible\r\n\r\n          -  Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for\r\n             treatment of either a psychiatric or medical (e.g. infectious) illness\r\n\r\n          -  Any underlying medical or psychiatric condition, which in the opinion of the\r\n             investigator will make the administration of CYT107 hazardous or obscure the\r\n             interpretation of adverse events (AEs), such as a condition associated with frequent\r\n             diarrhea\r\n\r\n          -  History of allergic reactions attributed to compounds of similar chemical or biologic\r\n             composition to CYT107\r\n\r\n          -  Patients who have received prior immunosuppressive therapy within 30 days prior to\r\n             enrollment\r\n\r\n          -  Active (as defined by requiring immunosuppressive therapy) or history of clinically\r\n             significant autoimmune disease (as defined by previously requiring immunosuppressive\r\n             therapy)\r\n\r\n          -  Patients who have received hepatotoxic drugs less than 7 days prior to enrollment\r\n\r\n          -  Patients who have received prior biologic agents less than 30 days prior to enrollment\r\n\r\n          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active\r\n             infection, congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or\r\n             psychiatric illness/social situations that would limit compliance with study\r\n             requirements\r\n\r\n          -  Patients who have a history of any hematopoietic malignancy\r\n\r\n          -  History of pulmonary disease such as emphysema or chronic obstructive pulmonary\r\n             disease (COPD), (forced expiratory volume [FEV] > 60% of predicted for height and age\r\n             required in patients with prolonged smoking history or symptoms of respiratory\r\n             dysfunction)\r\n      ","sponsor":"Fred Hutchinson Cancer Research Center","sponsor_type":"Other","conditions":"Castration Levels of Testosterone|Castration-Resistant Prostate Carcinoma|Metastatic Prostate Carcinoma|Stage IV Prostate Cancer","interventions":[{"intervention_type":"Biological","name":"Biological: Glycosylated Recombinant Human Interleukin-7","description":"Given SC"},{"intervention_type":"Other","name":"Other: Laboratory Biomarker Analysis","description":"Correlative studies"}],"outcomes":[{"outcome_type":"primary","measure":"Quantification of T-cell Responses to Prostatic Acid Phosphatase Granulocyte-macrophage Colony-stimulating Factor (PAP-GM-CSF), Assessed by Quantification of Interferon Gamma Levels Measured Using Enzyme-linked Immunospot (ELISPOT)","time_frame":"Day 70 (week 11)","description":"The Mann-Whitney-Wilcoxon (MWW) test will be used as part of the statistical analysis to determine quantification of T-cell responses to prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor (PAP-GM-CSF), as assessed by quantification of interferon gamma levels measured using enzyme-linked immunospot (ELISPOT). The power is roughly equivalent to that based on the t-test."},{"outcome_type":"secondary","measure":"Change in Bystander Antigen Specific Immune Responses, Measured by Interferon Gamma Production in Response to Various Antigens as Quantified by Enzyme-linked Immunospot (ELISPOT)","time_frame":"Baseline to up to week 53","description":"Bystander antigen specific immune responses will be assessed to other ongoing and nascent antitumor responses (e.g., preferentially expressed antigen in melanoma, cancer/testis antigen 1B and/or tumor protein p53), additional tumor antigens specific to prostate cancer (e.g., prostate specific antigen [PSA] and/or prostate-specific membrane antigen), and memory viral responses (influenza A and cytomegalovirus, Epstein-Barr virus and influenza virus-derived peptides) using the interferon gamma ELISPOT assay."},{"outcome_type":"secondary","measure":"Change in Circulating Tumor Cells","time_frame":"Baseline to up to week 53","description":"Enumerated by the approved Veridex assay."},{"outcome_type":"secondary","measure":"Change in Number of Peripheral Blood Mononuclear Cell (PBMC) Subsets and T Lymphocyte Subsets","time_frame":"Week 11","description":"The absolute fold change from baseline of CD3+ cells"},{"outcome_type":"secondary","measure":"Change in Prostate Specific Antigen (PSA) Kinetics.","time_frame":"Baseline to up to week 53","description":"The change in prostate specific antigen (PSA) kinetics will be evaluated according to the recommendations from PSA Working Group (PSAWG). Analysis of PSA doubling time"},{"outcome_type":"secondary","measure":"Change in Vaccine-induced Antigen-specific Antibody Immune Response to Prostatic Acid Phosphatase (PAP)","time_frame":"Baseline to up to week 6","description":"Will be measured by change in immunoglobulin G (IgG) and immunoglobulin M (IgM) levels quantified by standard enzyme-linked immunosorbent assay (ELISA). Fold change from baseline in week 6 titer"},{"outcome_type":"secondary","measure":"Overall Survival","time_frame":"Up to 5 years","description":"Number of participants that have survived"}]}
{"nct_id":"NCT02681458","start_date":"2013-08-31","enrollment":1436,"brief_title":"Superficial and Cutaneous Fungal Infections Among Drug-users in Northeast Region of Iran","official_title":"The Comparison of Dermatophytosis and Other Fungal Infections Between Drug Users and Non Drug Users","primary_completion_date":"2014-03-31","study_type":"Observational","rec_status":"Completed","completion_date":"2014-04-30","last_update":"2016-05-20","description":"The purpose of this study was about survey of prevalence of fungal infections among drug users referring to methadone wards of Hospitals in northeast region of Iran","other_id":"IslamicAUM","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","population":"people from northeast region of Iran referring to Methadone clinics. there were no\r\n        limitations of age and sex.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Suspected fungal lesions\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  non use of local or edible anti-fungal drugs and not taking bath within the last 48\r\n             hours of testing\r\n      ","sponsor":"Islamic Azad University of Mashhad","sponsor_type":"Other","conditions":"Skin and Subcutaneous Tissue Fungal Infections","interventions":[{"intervention_type":"Other","name":"Other: Direct Examination","description":"It was an observational study and subjects received their routine treatment."}],"outcomes":[{"outcome_type":"primary","measure":"The Prevalence of Superficial and Cutaneous Fungal Infections Among Drug and Non-Drug Users","time_frame":"up to two months"}]}
{"nct_id":"NCT01917994","start_date":"2013-08-31","phase":"N/A","enrollment":230,"brief_title":"Text Messaging Intervention to Improve Retention in Care and Virologic Suppression in an Urban HIV-Infected Population","official_title":"Seek Test Treat Retain Strategies Leveraging Mobile Health Technologies","primary_completion_date":"2016-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-12-31","last_update":"2017-02-08","description":"Retention in care and virologic suppression are the key final steps of the HIV treatment cascade. Poor or intermittent retention has been associated with later initiation of antiretroviral therapy, virologic failure, and death. Regular HIV care has also been associated with a decrease in HIV transmission risk behavior. Despite the proven health and prevention benefits of consistent HIV care, only 40-50% of those infected with HIV in the United States are estimated to meet current retention in care standards and even fewer - only about 25% - are estimated to be virologically suppressed. The Behavioral Model for Vulnerable Populations provides a useful framework for understanding broad areas that may impact adherence to care and treatment. Individual-level domains include vulnerable (e.g., depression, stigma), enabling (e.g., social support, positive affect), and need (e.g., co-morbidities) factors, and structural domains include, for example, features or the clinic and the provider-patient relationship. Short message service (SMS) technology represents a new and exciting tool to help retain HIV-infected patients in care and treatment. SMS interventions have been deployed successfully in support of antiretroviral adherence and virologic suppression in sub-Saharan Africa, where two randomized trials have showed clear benefits. A pilot study conducted in our clinic suggests that use of SMS messages to promote adherence to care and treatment in the urban HIV-infected poor is both feasible and acceptable. The investigators believe that combining SMS technology with content-specific messages designed to impact factors highlighted in the Behavioral Model for Vulnerable Populations can improve retention in care and virologic suppression for an urban public hospital population living with HIV, thus the investigators propose the following specific aims. Specific Aim 1: Determine whether a behavioral theory-based SMS intervention improves virologic suppression [primary outcome] and retention in care [secondary outcome] for a vulnerable urban HIV-infected population through a randomized trial of this technology compared to SMS appointment reminders alone. Retention in care will also be analyzed as a mediator of virologic suppression. Exploratory outcomes include time to virologic suppression, sustained virologic suppression, emergency department utilization and antiretroviral adherence, as well as levels of depression, positive affect, social support and empowerment. Specific Aim 2: Examine patient experiences with the SMS intervention, focusing specifically on: 1) satisfaction with this technology; 2) identifying barriers to and facilitators of patient use of this technology, and; 3) the preferred frequency and content of intervention messages. Specific Aim 3: Conduct cost and cost-effectiveness analyses of the SMS intervention.","other_id":"R01DA032057","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  HIV-infected\r\n\r\n          -  Age 18 or over\r\n\r\n          -  English-speaking\r\n\r\n          -  Able to give informed consent\r\n\r\n          -  Have a cell phone and willing to send/receive up to 25 text messages/month\r\n\r\n          -  Detectable viral load plus either 1) new to clinic (no more than 2 primary care\r\n             visits) or 2) history of poor retention (one missed visit or lack of six-month visit\r\n             constancy in the past year)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  HIV-uninfected\r\n\r\n          -  Under age 18\r\n\r\n          -  Monolingual speaker of a language other than English\r\n\r\n          -  Unable to give informed consent\r\n\r\n          -  Undetectable viral load\r\n\r\n          -  Perfect appointment adherence\r\n      ","sponsor":"University of California, San Francisco","sponsor_type":"Other","conditions":"HIV|Patient Adherence|Mobile Technology","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Text Messages","description":"The intervention consists of supportive, informational, and motivational text messages three times a week targeting the following domains: promoting a sense of connectedness to the clinic, fostering social support, building empowerment, ameliorating negative affect, cultivating positive affect, and promoting healthy behaviors and adherence to antiretroviral medication."},{"intervention_type":"Behavioral","name":"Behavioral: Appointment Reminders"}],"outcomes":[{"outcome_type":"secondary","measure":"Missed Visit Proportion","time_frame":"12 month","description":"Number of missed or \"no show\" visits divided by number of scheduled appointments"},{"outcome_type":"secondary","measure":"Appointment Adherence","time_frame":"12 month","description":"Each participant's proportion of kept appts divided by scheduled appts (mean of the proportions)"},{"outcome_type":"secondary","measure":"Visit Constancy","time_frame":"12 month","description":"At least one kept visit in each six-month period"},{"outcome_type":"secondary","measure":"Attended All Scheduled Visits","time_frame":"12 month","description":"Attended all scheduled visits"},{"outcome_type":"other","measure":"Time to Virologic Suppression","time_frame":"12 month"},{"outcome_type":"other","measure":"Sustained virologic suppression","time_frame":"12 month"},{"outcome_type":"primary","measure":"Viral Load","time_frame":"12 month"}]}
{"nct_id":"NCT01936623","start_date":"2013-08-31","phase":"N/A","enrollment":80,"brief_title":"Computerized Brief Intervention vs. Delayed Computerized Brief Intervention","primary_completion_date":"2014-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-09-30","last_update":"2017-07-21","description":"The purpose of the study is to determine whether a computerized brief intervention for moderate risk drug use among adult primary care patients is more effective than providing such patients with a substance abuse assessment alone.","other_id":"1R01DA026003-B","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  (1) minimum 18 years of age\r\n\r\n          -  (2) primary care or dental patients at the participating clinics\r\n\r\n          -  (3) score between 4 and 26 (moderate-risk) for illicit drug and/or nonmedical use of\r\n             prescription drugs on any of the single item drug use risk scores of the ASSIST.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  (1) score in the high-risk range on the ASSIST for any drug (except tobacco) or\r\n             alcohol use (i.e., ASSIST score > 26)\r\n\r\n          -  (2) no reported drug use within the past 3 months\r\n\r\n          -  (3) drug abuse treatment within the past 12 months\r\n\r\n          -  (4) a BI at the clinic with the behavioral health counselor within the past month\r\n\r\n          -  (5) prior enrollment in the parent study;\r\n\r\n          -  (6) plans to move out of New Mexico in the next 6 months\r\n      ","sponsor":"Friends Research Institute, Inc.","sponsor_type":"Other","conditions":"Drug Abuse","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Computerized Brief Intervention","description":"No additional information needed."}],"outcomes":[{"outcome_type":"primary","measure":"Alcohol, Smoking, and Substance Involvement Screening Tests (ASSIST) Global Continuum of Illicit Drug Risk Score","time_frame":"3 month follow-up","description":"The ASSIST Global Continuum of Illicit Drug Risk Score ranges from 0 to 308, with higher scores indicating greater risk."},{"outcome_type":"secondary","measure":"Alcohol, Smoking, and Substance Involvement Screening Tests (ASSIST) Global Continuum of Illicit Drug Risk Score","time_frame":"6-month follow-up","description":"The ASSIST Global Continuum of Illicit Drug Risk Score ranges from 0 to 308, with higher scores indicating greater risk."},{"outcome_type":"other","measure":"Number of Subjects Testing Positive on Hair Testing for Marijuana, Cocaine, Amphetamines, or Opioids.","time_frame":"3-month","description":"Radioimmunoassay (RIA) Tests were used."},{"outcome_type":"other","measure":"Number of Subjects Positive on Hair Testing for Marijuana, Cocaine, Amphetamines, or Opioids","time_frame":"6-month follow-up","description":"Radioimmunoassay Testing (RIA) was conducted"}]}
{"nct_id":"NCT01924832","start_date":"2013-08-31","phase":"Phase 1","enrollment":32,"brief_title":"BG00012 Regional Absorption Study","official_title":"Study to Investigate the Pharmacokinetics, Safety, and Tolerability of BG00012 (Dimethyl Fumarate) When Delivered to Different Regions of the Gastrointestinal Tract in Healthy Subjects","primary_completion_date":"2014-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-04-30","last_update":"2015-02-16","description":"The primary objective of this study is to evaluate the pharmacokinetics (PK) profile of monomethyl fumarate (MMF) following delivery of BG00012 (dimethyl fumarate, DMF) 120 mg (Part 1) and BG00012 240 mg (Part 2) to varying regions within the GI tract in healthy volunteers. The secondary objective of this study is to evaluate the safety and tolerability profile following the delivery of BG00012 120 mg (Part 1) and BG00012 240 mg (Part 2) to varying regions within the GI tract in healthy volunteers.","other_id":"109HV111","allocation":"Non-Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Key Inclusion Criteria:\r\n\r\n          -  Healthy males or non-pregnant, non-lactating healthy females.\r\n\r\n          -  Body mass index (BMI) of 18 through 35 kg/m2.\r\n\r\n          -  Subjects of childbearing potential (including males) must practice effective\r\n             contraception during the study and be willing and able to continue contraception for\r\n             90 days after their last dose of study treatment\r\n\r\n        Key Exclusion Criteria:\r\n\r\n          -  History of or positive test result at Screening for human immunodeficiency virus\r\n             (HIV), hepatitis C virus (HCV) antibody, or hepatitis B virus (defined as positive for\r\n             hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb]).\r\n\r\n          -  Serious infection (e.g., pneumonia, septicemia) within the 3 months prior to first\r\n             dose.\r\n\r\n          -  Vaccinations within 4 weeks prior to first dose.\r\n\r\n          -  History of drug or alcohol abuse (as defined by the Investigator) within the previous\r\n             2 years, or regular alcohol consumption in males >21 units per week and females >14\r\n             units per week (1 unit =  pint of beer, 25 mL of 40% spirit or a 125 mL glass of\r\n             wine).\r\n\r\n          -  History of clinically significant gastrointestinal (GI) disease as determined by the\r\n             Investigator (including Crohn's Disease, Ulcerative Colitis, confirmed diagnosis of\r\n             active Irritable Bowel Syndrome).\r\n\r\n          -  History of any clinically significant cardiac, endocrinologic, hematologic, hepatic,\r\n             immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric,\r\n             and renal, or other major disease, as determined by the Investigator.\r\n\r\n        NOTE: Other protocol-defined inclusion/exclusion criteria may apply.\r\n      ","sponsor":"Biogen","sponsor_type":"Industry","conditions":"Healthy","interventions":[{"intervention_type":"Drug","name":"Drug: dimethyl fumarate","description":"tablet"}],"outcomes":[{"outcome_type":"primary","measure":"The maximum observed concentration: Cmax","time_frame":"Up to week 9"},{"outcome_type":"primary","measure":"The time to reach maximum observed concentration: Tmax","time_frame":"Up to week 9"},{"outcome_type":"primary","measure":"The area under the plasma concentration versus time curve from time zero to 24 hours","time_frame":"Up to week 9"},{"outcome_type":"primary","measure":"The area under the plasma concentration versus time curve from time zero to time t (the last sampling time with quantifiable monomethyl fumarate [MMF])","time_frame":"Up to week 9"},{"outcome_type":"primary","measure":"The area under the plasma concentration versus time curve from time zero to infinity","time_frame":"Up to week 9"},{"outcome_type":"primary","measure":"The apparent elimination half-life","time_frame":"Up to week 9"},{"outcome_type":"primary","measure":"The time prior to the first quantifiable monomethyl fumarate (MMF) plasma concentration","time_frame":"Up to week 9"},{"outcome_type":"primary","measure":"Area under the plasma concentration versus time curve (AUC) ratio of test regimens compared with reference for Part 1","time_frame":"Up to week 9"},{"outcome_type":"primary","measure":"Area under the plasma concentration versus time curve (AUC) ratio of test regimens compared with reference for Part 2","time_frame":"Up to week 9"},{"outcome_type":"secondary","measure":"The number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)","time_frame":"Up to week 9"}]}
{"nct_id":"NCT01942330","start_date":"2013-08-31","phase":"N/A","enrollment":110,"brief_title":"Pain and Infection After Transvaginal Colectomy","official_title":"Prospective Evaluation of a Laparoscopic-Assisted Transvaginal Approach for Colonic Resection","primary_completion_date":"2018-08-31","study_type":"Interventional","rec_status":"Unknown status","last_update":"2017-10-31","description":"This study aims to prospectively evaluate a laparoscopic-assisted transvaginal approach for colonic resection in adult women that eliminates the need for an abdominal incision to remove surgical specimens. It is hypothesized that this LANOS technique will improve patient outcomes such as postoperative surgical site infection (SSI) rates, thereby improving patient satisfaction and also reducing hospital length-of-stay and cost.","other_id":"Pro00006972","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Females  18 years of age\r\n\r\n          2. Diagnosed with one of the following benign or malignant conditions for which they\r\n             require colonic resection with a specimen that may be removed transvaginally if\r\n             randomized to that group:\r\n\r\n               -  Adenomatous polyposis\r\n\r\n               -  Chronic GI bleeding\r\n\r\n               -  Chronic obstruction\r\n\r\n               -  Colon cancer\r\n\r\n               -  Colonic inertia\r\n\r\n               -  Diverticular disease\r\n\r\n               -  Rectal cancer\r\n\r\n               -  Colorectal Polyps\r\n\r\n               -  Rectal prolapse\r\n\r\n               -  Slow transit constipation / colonic inertia\r\n\r\n          3. Require one of the following elective operations that may be safely performed by\r\n             current laparoscopic-assisted techniques:\r\n\r\n               -  Right hemicolectomy\r\n\r\n               -  Left hemicolectomy\r\n\r\n               -  Subtotal colectomy\r\n\r\n               -  Total abdominal colectomy\r\n\r\n               -  Sigmoid colectomy\r\n\r\n               -  Rectosigmoid resection\r\n\r\n               -  Low anterior resection\r\n\r\n          4. Willingness and ability to comply with the requirements of the study protocol\r\n             including follow-up\r\n\r\n          5. Willingness and ability to sign the study specific informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Current pregnancy or considering becoming pregnant during the follow-up period or\r\n             within 6 months of surgery\r\n\r\n          2. Any anatomical consideration that in the Investigator's opinion would make the\r\n             traditional laparoscopic or transvaginal approach to resection excessively risky or\r\n             impossible. Patients with bulky tumors that would require open operations are not\r\n             candidates for this study.\r\n\r\n          3. Body Mass Index (BMI) > 35\r\n\r\n          4. Vaginal stenosis\r\n\r\n          5. Prior reconstructive surgery of the vagina not including hysterectomy\r\n\r\n          6. ASA classes 4 and 5\r\n\r\n          7. Advanced renal insufficiency (estimated creatinine clearance 30 mL/min/1.73 m2)\r\n\r\n          8. Any history of pelvic radiation\r\n\r\n          9. Anticipated need for an ostomy at the time of operation\r\n\r\n         10. Patients requiring urgent or emergent surgery\r\n\r\n         11. Patients with prior or suspected diagnosis of inflammatory bowel disease such as\r\n             Crohns disease or ulcerative colitis.\r\n      ","sponsor":"Jaime Sanchez","sponsor_type":"Other","conditions":"Colonic Resection Procedures","interventions":[{"intervention_type":"Procedure","name":"Procedure: Laparoscopic-Assisted Natural Orifice Surgery","description":"Surgical procedure performed using an operating endoscope that is introduced into the body through a natural orifice and is then passed into the peritoneal cavity through the lumen of an organ such as the stomach, bowel or vagina."}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of Post-operative Infections","time_frame":"Post-operative day 1 through 1 year","description":"To evaluate the effects of a laparoscopic-assisted transvaginal colonic resection on postoperative recovery, as measured primarily by surgical site infection rates, compared to standard laparoscopic-assisted colonic resection."},{"outcome_type":"secondary","measure":"Post-operative Pain","time_frame":"Post-operative day 1 through 1 year","description":"1. Pain score assessments: The investigator's staff will provide a rating scale to the patients to self-rate and record their pain at baseline (prior to surgery), at 24, 48, 72, 96, 120, 144 and 168 hours following the procedure end time (or discharge if earlier), and at 14 ± 7 days, 30 ± 7 days, 60 ± 14 days, and 12 months ± 14 days postoperatively using a 10 point visual analogue and pain faces scale where 0 is for no pain and 10 is for the worst pain imaginable. . These data will be recorded using the Pain Assessment Form. In addition, the amount of narcotic pain medication administered through postoperative day 7 (or discharge if earlier) will be recorded and analyzed as morphine equivalents."}]}
{"nct_id":"NCT01829178","start_date":"2013-08-31","phase":"Phase 2/Phase 3","enrollment":30,"brief_title":"Evaluation of Effects of Silymarin on Cisplatin Induced Nephrotoxicity in Upper Gastrointestinal Adenocarcinoma","official_title":"Phase 2-3 Study of Silymarin on Cisplatin Induced Nephrotoxicity","primary_completion_date":"2014-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-09-30","last_update":"2015-05-13","description":"Cisplatin is a potent chemotherapeutic agent that has been widely used to treat many solid tumours. acute renal failure, despite conservative fluid and electrolyte management, frequently reported adverse event and limiting cisplatin use. Silymarin, a flavonolignan complex isolated from Silybum marianum, has a strong antioxidant, hepatoprotective, anticancer and in animal model nephroprotective properties. Neutrophil gelatinase-associated lipocalin (NGAL) protein is a promising biomarker to detect acute kidney injury due to cisplatin. Milk thistle extract inhibitory effects on epidermal growth factor receptor, vascular endothelial growth factor and insulin-like growth factor-I have shown in the previous in-vitro studies.The aim of present study,a randomized double-blind placebo- controlled clinical trial, to investigate the therapeutic effect of silymarin on cisplatin induced nephrotoxicity and it's impact on chemotherapy. Fifty-eight patients with diagnosed upper gastrointestinal tract carcinomas randomized to silymarin (420mg) or placebo plus chemotherapy [cisplatin 50-60 mg/m2, 5-fluorouracil mg/m2, docetaxel 60-80 mg/m2 every 21 days] for 63 day after inclusion. serum creatinin, blood urea nitrogen (BUN), serum and urine electrolyte will be measured daily during chemotherapy. changes in urine NGAL, serum vascular endothelial growth factor (VEGF)and caspase activity assessed up to 64 days.","other_id":"91-03-33-18878","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  age>18 years\r\n\r\n          -  diagnosed\r\n\r\n          -  measurable upper gastrointestinal adenocarcinoma\r\n\r\n          -  swallow problem\r\n\r\n          -  would like to participate in the study\r\n\r\n          -  Glomerular filtration rate(GFR)>45ml/min/1.73m2\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  end stage renal disease\r\n\r\n          -  requiring dialysis\r\n\r\n          -  post transplantation\r\n\r\n          -  receiving contrast media during last 72 hours\r\n\r\n          -  chronic use of corticosteroids\r\n\r\n          -  chronic use of angiotensin-converting enzyme inhibitor(ACEI )\r\n\r\n          -  untreated hypo-and hyperthyroidism\r\n\r\n          -  ejection fraction<60%\r\n\r\n          -  active urinary tract infection\r\n\r\n          -  iver disease ( five fold increase of liver enzyme in asymptomatic or 3 fold increase\r\n             in symptomatic\r\n\r\n          -  use of other nephrotoxic agents such as aminoglycoside, amphotericin\r\n\r\n          -  karnofsky performance status <70\r\n      ","sponsor":"Tehran University of Medical Sciences","sponsor_type":"Other","conditions":"Upper GI Cancer|Cisplatin Adverse Reaction","interventions":[{"intervention_type":"Drug","name":"Drug: Silymarin","description":"Silymarin 420 mg in 3 divided dose plus standard chemotherapy"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"placebo tablets: 420 mg in 3 divided dose"},{"intervention_type":"Drug","name":"Drug: chemotherapy","description":"All patients will receive standard chemotherapy: cisplatin 50-60mg/m2 + fluorouracil 750 mg/m2 + docetaxel 60-80 mg/m2"}],"outcomes":[{"outcome_type":"primary","measure":"Urine concentration of NGAL","time_frame":"up to 9 weeks","description":"All subject receive silymarin at dose of 420mg or placebo in three dose for 65 consecutive day, urine NGAL concentration will be measured."},{"outcome_type":"secondary","measure":"Changes in VEGF Serum concentration","time_frame":"up to 9 weeks","description":"To assess interaction between silymarin and cancer chemotherapy serum vascular endothelial growth factor will be measured."},{"outcome_type":"secondary","measure":"Tissue activity of caspase 3","time_frame":"up to 9 weeks","description":"To assess interaction between silymarin and cancer chemotherapy Tissue activity of caspase 3will be measured."}]}
{"nct_id":"NCT02880826","start_date":"2013-08-31","enrollment":4800,"brief_title":"Measurement of Care Safety Culture in French ICU, Correlation With the Characteristics of Morbi-mortality Reviews","official_title":"Study on the Measurement of Care Safety Culture in French ICU, Correlation With the Characteristics of Morbi-mortality Reviews","primary_completion_date":"2014-04-30","study_type":"Observational","rec_status":"Completed","completion_date":"2014-04-30","last_update":"2016-08-26","description":"The tools to measure safety culture (CS) have recently become available. No study has focused on the measure in France, apart from pilot studies. intensive services are particularly at risk of serious adverse events occurred (SAEs). Patients who are hospitalized are in fact fragile and precarious clinical condition requires rapid decision taken often. Diagnostic or therapeutic strategies have report \"risk-benefit\" narrow. They may well be complicated by EIG.Safety of care is a priority in the field of health in general, and especially in intensive care. CS measure in this context seems particularly relevant. The main objective is to describe the CS intensive care units in France. The study will explore the development of the CS level for the units investigated. This study will also describe the main features of RMM practiced in intensive care units in France.","other_id":"RC13_0028","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","population":"60 intensive care units in France. Each unit is estimated that an average of 80\r\n        professionals will be subject to the evaluation of the CS (doctors, IDE, assistant nurses,\r\n        physiotherapists...) and thus nearly 4800 people will be included for the CS measurement.\r\n\r\n        Includes: all professionals providing care to patients and working full-time or part-time\r\n        work in the respondent unit.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  practicing resuscitation activity (this practice is medical or surgical, pediatric or\r\n             adult, in public or private sector)\r\n\r\n          -  volunteer to participate in the study (agreement of the head of the unit)\r\n\r\n          -  for which at least 2 matching / references for the study were identified:\r\n\r\n               -  a medical officer,\r\n\r\n               -  caregiver responsible (Health Framework).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  measurement safety culture done in a period of significant change during a period\r\n             where the staff and activities of the respondent unit of work is relatively stable.\r\n\r\n          -  the responses of professionals to the questionnaire can be influenced by internal\r\n             factors in their work unit (recent accident occurred, change of close supervision,\r\n             personnel changes ...) and by factors external to their unit work (establishment\r\n             certification period, arrival of a new director, recent media coverage of medical\r\n             accidents ...).\r\n      ","sponsor":"Nantes University Hospital","sponsor_type":"Other","conditions":"Emergency","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Measure the culture of safety in the reanimation units"}],"outcomes":[{"outcome_type":"primary","measure":"The measure of the CS of intensive care units in France using a validated questionnaire","time_frame":"The planned project duration is 12 months"}]}
{"nct_id":"NCT01890655","start_date":"2013-08-31","phase":"Phase 2","enrollment":367,"brief_title":"Extension Study of MT-1303","official_title":"A Phase II, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects With Relapsing-remitting Multiple Sclerosis Who Have Completed the MT-1303-E04 Study","primary_completion_date":"2016-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-03-31","last_update":"2016-04-11","description":"To evaluate the long-term safety and tolerability of MT-1303 in subjects with relapsing remitting multiple sclerosis (RRMS).","other_id":"MT-1303-E05","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Completion of the 24-week treatment period in MT-1303-E04 as per protocol\r\n\r\n          -  Able to provide written informed consent and to comply with the requirements of the\r\n             protocol\r\n\r\n          -  For males and females of reproductive potential, two methods of contraception must be\r\n             used throughout the study and for 12 weeks after cessation of study medication. At\r\n             least one of the methods of contraception must be a barrier method.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Permanent discontinuation of study medication prior to the end of treatment (EOT)\r\n             visit in MT-1303-E04\r\n\r\n          -  Newly diagnosed diabetes mellitus during MT-1303-E04\r\n      ","sponsor":"Mitsubishi Tanabe Pharma Corporation","sponsor_type":"Industry","conditions":"Relapsing-remitting Multiple Sclerosis","interventions":[{"intervention_type":"Drug","name":"Drug: MT-1303-Low"},{"intervention_type":"Drug","name":"Drug: MT-1303-Middle"},{"intervention_type":"Drug","name":"Drug: MT-1303-High"}],"outcomes":[{"outcome_type":"primary","measure":"Safety assessments","time_frame":"Month 18","description":"Adverse Events"},{"outcome_type":"secondary","measure":"Clinical efficacy","time_frame":"Month 18","description":"Annualised relapse rate(ARR)"},{"outcome_type":"secondary","measure":"Magnetic Resonance Imaging (MRI)","time_frame":"Month 18","description":"Change and percent change in brain volume at EOT"}]}
{"nct_id":"NCT01805440","start_date":"2013-08-31","phase":"N/A","enrollment":62,"brief_title":"Uridine Adolescent Bipolar Depression Randomized Controlled Trial","official_title":"Placebo-Controlled Study of Uridine for Adolescent Bipolar Depression: a Magnetic Resonance Spectroscopy Study","primary_completion_date":"2015-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-12-31","last_update":"2018-03-12","description":"This is a randomized, double-blind, placebo-controlled study of the investigational drug uridine as a treatment for depressed adolescents with bipolar disorder (i.e. \"bipolar depression\"). Participants initially randomized to placebo who complete the 6-week protocol will be offered 6 months of open-label uridine treatment and follow-up. Participants initially randomized to uridine will be offered the open-label treatment as well.","other_id":"University of Utah","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":13,"maximum_age":21,"population":"","criteria":"\n        Inclusion Criteria For Bipolar Disorder Participants:\r\n\r\n          -  Participants under 18 years of age must be able to provide assent, and have the\r\n             permission of a parent or guardian. Participants 18 years of age or older must be able\r\n             to provide informed consent.\r\n\r\n          -  Participants must be between the ages of 13 and 21 years.\r\n\r\n          -  Participants must meet DSM criteria for Bipolar Disorder (Type I, II, or NOS), with\r\n             current mood state depressed for at least 2 weeks.\r\n\r\n          -  Participants must have a current Children's Depression Rating Scale-Revised (CDRS-R)\r\n             score of 45 or greater, and/or a Montgomery/Asberg Depression Rating Scale (MADRS)\r\n             score of 25 or greater.\r\n\r\n        Inclusion Criteria For Healthy Comparison Participants:\r\n\r\n          -  Participants under 18 years of age must be able to provide assent, and have the\r\n             permission of a parent or guardian. Participants 18 years of age or older must be able\r\n             to provide informed consent.\r\n\r\n          -  Participants must be between the ages of 13 and 21 years.\r\n\r\n          -  Participants must not meet any DSM-IV criteria for a psychiatric illness or substance\r\n             use disorder\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Participants must not meet DSM criteria for a primary psychotic disorder, a\r\n             developmental disorder or substance use disorder.\r\n\r\n          -  Participants must not be at high risk for suicidal or homicidal actions.\r\n\r\n          -  Participants must not be pregnant or breastfeeding.\r\n\r\n          -  Participants must not have a contraindication to magnetic resonance imaging (e.g.\r\n             ferromagnetic implant, or claustrophobic anxiety).\r\n\r\n          -  Incarcerated persons are excluded, because this study is not approved for Research\r\n             Involving Prisoners.\r\n      ","sponsor":"University of Utah","sponsor_type":"Other","conditions":"Bipolar Disorder|Bipolar Depression|Manic Depression","interventions":[{"intervention_type":"Drug","name":"Drug: Uridine","description":"Uridine is the active treatment in this clinical trial."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Pill placebo is the inactive treatment comparator in this clinical trial."}],"outcomes":[{"outcome_type":"primary","measure":"Change in GLX (Glutamate + Glutamine) to Creatine (Cr) Ratio in the Anterior Cingulate Cortex of the Brain, as Measured With Proton-1 Magnetic Resonance Spectroscopy (1H-MRS).","time_frame":"Baseline and 6 weeks","description":"Magnetic Resonance Spectroscopy is a safe, non-invasive method for measuring brain chemicals thought to be involved in mood disorders, such as GLX (glutamate + glutamine). Previous research indicates that adolescents with bipolar depression have elevated Glx concentrations, compared with controls. The measurement of Glx with 1H-MRS has the potential to identify translational biomarkers of juvenile BD pathophysiology and treatment response."},{"outcome_type":"primary","measure":"Change in Children's Depression Rating Scale-Revised (CDRS-R) Score.","time_frame":"6 weeks","description":"The CDRS-R is a brief rating scale based on a semi-structured interview with the participant (and/or their parent or guardian). The scale can be administered and scored in under 30 minutes. The CDRS-R gives you a single summary score -- with an interpretation of, and clinical recommendations for, six different score ranges. Total possible scores range from 17 to 113, with higher scores indicating more depressive symptoms reported by the participant (and/or their parent or guardian)."},{"outcome_type":"secondary","measure":"Columbia-Suicide Severity Rating Scale (C-SSRS)","time_frame":"6 weeks","description":"The Columbia-Suicide Severity Rating Scale (C-SSRS) is used to measure suicidal thoughts and behaviors in Investigational New Drug (IND) studies. The C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from \"wish to be dead\" to \"active suicidal ideation with specific plan and intent.\" The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent)."}]}
{"nct_id":"NCT02797808","start_date":"2013-08-31","phase":"Phase 1/Phase 2","enrollment":41,"brief_title":"Effects of Sertraline on Brain Connectivity in Adolescents With OCD","official_title":"Effects of Sertraline on Brain Connectivity in Adolescents With OCD (Obsessive-Compulsive Disorder)","primary_completion_date":"2017-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-01-31","last_update":"2021-01-05","description":"The investigators will examine how treatment with sertraline for 12 weeks impacts frontal-striatal-thalamic circuitry (FSTC) in this OCD sample.","other_id":"1105M99532","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":8,"maximum_age":17,"population":"","criteria":"\n        Inclusion Criteria (OCD):\r\n\r\n          -  OCD as the primary Diagnostic and Statistical Manual of Mental Disorders, 4th Edition\r\n             (DSM-IV) diagnosis based on the Anxiety Disorders Interview Schedule (ADIS) for\r\n             DSM-IV, Child Version\r\n\r\n          -  Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) score of greater than 15\r\n\r\n        Exclusion Criteria (OCD):\r\n\r\n          -  lifetime diagnosis of bipolar disorder, schizophrenia, or substance abuse/dependence\r\n             on ADIS\r\n\r\n          -  Intelligence Quotient (IQ) < 80 on Wechsler Abbreviated Scales of Intelligence (WASI)\r\n\r\n          -  positive urine drug screen\r\n\r\n          -  MRI-incompatible features (e.g., metal implants, claustrophobia)\r\n\r\n          -  current or recent trial of psychotropic medication (within the past 4 8 weeks or past\r\n             6 12 weeks for fluoxetine)\r\n\r\n          -  non-response in > 2 selective serotonin reuptake inhibitor (SSRI) trials of adequate\r\n             dose/duration\r\n\r\n          -  positive pregnancy test\r\n\r\n          -  history of seizure disorder or serious head injury\r\n\r\n        Inclusion Criteria (Controls):\r\n\r\n          -  Healthy 8-17 year olds\r\n\r\n        Exclusion criteria (controls):\r\n\r\n          -  No psychiatric diagnoses\r\n\r\n          -  No immediate family history of OCD\r\n      ","sponsor":"University of Minnesota","sponsor_type":"Other","conditions":"OCD","interventions":[{"intervention_type":"Drug","name":"Drug: Sertraline","description":"Impact of sertraline on functional brain connectivity"},{"intervention_type":"Other","name":"Other: No Intervention","description":"Healthy control non-intervention"}],"outcomes":[{"outcome_type":"primary","measure":"CY-BOCS Total Score at 12-weeks","time_frame":"12 weeks","description":"The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) a clinician-rated semi-structured instrument assessing OCD severity over the previous 7 days in children ages 6 to 17 years. Items are scored from 0 (none) to 4 (extreme) and total score ranges from 0 to 40 with higher scores indicating greater impairment. All 19 items are rated, but only items 1-10 are used to determine the total score. The total CY-BOCS score is the sum of items 1-10; the obsession and compulsion subtotals are the sums of items 1-5 and 6-10, respectively. At this time, items 1A and 6A are not being used in the scoring. Items 17 (global severity) and 18 (global improvement) are adapted from the Clinical Global Impression Scale to provide measures of overall functional impairment associated with the presence of obsessive-compulsive symptoms."},{"outcome_type":"primary","measure":"Longitudinal 2-Group Resting State Functional Conectivity (RSFC) Analyses","time_frame":"12 weeks","description":"Participants had whole brain fMRI at baseline &12 weeks. Whole brain connectivity in 6 striatal ROIs was performed. Two-way mixed effects ANOVAs were performed with FEAT. Clusters were significant if p <.0042 based on .05/(6 ROIs x 2 tests/ROI). Mean z-score was found for each time point in each subject's connectivity map in each significant cluster. Within-group paired-sample t tests examined RSFC change over time in these metrics for each group. To investigate group X time interactions from the 2-way ANOVA, we compared mean z-scores within each significant cluster at baseline & 12 weeks. Resulting numbers represented striatal connectivity for each individual at each time point. Within group paired sample t-tests examined RSFC change over time for each group. Bonferroni correction was applied to alpha level (2-tailed, p<0.5/6 =.0083) for multiple testing. We do not have an a priori hypothesis as to whether increase or decrease in RSFC is a better outcome. Unit of measure is z-score."}]}
{"nct_id":"NCT01931007","start_date":"2013-08-31","phase":"Phase 1","enrollment":25,"brief_title":"Use of Autologous Bone Marrow Aspirate Concentrate in Painful Knee Osteoarthritis","official_title":"Use of Autologous Bone Marrow Aspirate Concentrate in Painful Knee Osteoarthritis, A Randomized Placebo Controlled Pilot Study","primary_completion_date":"2016-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-01-31","last_update":"2017-05-05","description":"The overall goal of this study is to develop regenerative cell therapy for use in patients with osteoarthritis (OA). The primary objective of this proposal is to conduct a pilot study that assesses the safety and feasibility of using concentrated bone marrow aspirate containing MSC to treat patients with painful knee OA.","other_id":"12-004459","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":99,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Male and Female subjects are both eligible\r\n\r\n          2. Subjects must be 18 years of age or older\r\n\r\n          3. Subjects must have bilateral OA and pain in both knees.\r\n\r\n          4. Osteoarthritis may be primary or secondary. Knees must have Kellgren-Lawrence Grades\r\n             1-3.\r\n\r\n          5. Subjects must have previously tried 6 weeks of one of the following conservative\r\n             treatments Activity modification, weight loss; physical therapy, anti-inflammatory or\r\n             injection therapy\r\n\r\n          6. Patients can provide written informed consent after the nature of the study is fully\r\n             explained\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients with abnormal hematology, serum chemistry, or urinalysis screening laboratory\r\n             results.\r\n\r\n          2. Patients taking anti-inflammatory medications (prescription or over-the-counter),\r\n             including herbal therapies, within 14 days of baseline visit.\r\n\r\n          3. Patients taking anti-rheumatic disease medication (including methotrexate or other\r\n             antimetabolites) within the 3 months prior to study entry.\r\n\r\n          4. Patients receiving injections to the treated knee within 2 months prior to study\r\n             entry.\r\n\r\n          5. Patients who are pregnant or currently breast-feeding children.\r\n\r\n          6. Patients with systemic, rheumatic or inflammatory disease of the knee or\r\n             chondrocalcinosis, hemochromatosis, inflammatory arthritis, arthropathy of the knee\r\n             associated with juxta-articular Paget's disease of the femur or tibia, ochronosis,\r\n             hemophilic arthropathy, infectious arthritis, Charcot's knee joint, villonodular\r\n             synovitis, and synovial chondromatosis.\r\n\r\n          7. Patients with ongoing infectious disease, including HIV and hepatitis\r\n\r\n          8. Patients with clinically significant cardiovascular, renal, hepatic, endocrine\r\n             disease, cancer, or diabetes\r\n\r\n          9. Patients participating in a study of an experimental drug or medical device within 30\r\n             days of study entry.\r\n      ","sponsor":"Mayo Clinic","sponsor_type":"Other","conditions":"Bilateral Primary Osteoarthritis of Knee","interventions":[{"intervention_type":"Drug","name":"Drug: Autologous Bone Marrow Aspirate Concentrate","description":"Autologous Bone marrow aspirate will be concentrated using Magellan Cell Separator and stem cell kit according to the Standard Operating Procedures is to be injected in the treatment knee. 5ml of treatment cells will be combined with 10 ml of previously separated platelet poor bone marrow plasma and used for injection under ultrasound guidance into one of the subject's painful knees."},{"intervention_type":"Drug","name":"Drug: Sterile saline","description":"Bacteriostatic 0.9% sodium chloride, preservative free manufactured by Hospira will be injected into the control knee."}],"outcomes":[{"outcome_type":"primary","measure":"Number of Subjects with Adverse Reactions to Concentrated Mesenchymal Stem Cells (MSCs)","time_frame":"1 year","description":"Occurrence of adverse reactions to concentrated MSCs from bone marrow aspiration injected into knee joints."},{"outcome_type":"secondary","measure":"Mean Knee Cartilage","time_frame":"baseline, 6 months, 1 year","description":"Knee cartilage status will be measured prior to injection, at 6 months following injection, and at 12 months following injection. The cartilage will be measured by MRI at baseline and 6 months using MRI and cartilage sequencing techniques, and knee radiographs at 12 months."}]}
{"nct_id":"NCT02156791","start_date":"2013-08-31","phase":"Phase 2","enrollment":61,"brief_title":"Safety, Clinical Tolerability and Immunogenicity of Increasing Doses of gpASIT+TM","official_title":"Safety, Clinical Tolerability and Immunogenicity of Increasing Doses of gpASIT+TM Administered Subcutaneously to Hay Fever Patients","primary_completion_date":"2013-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-12-31","last_update":"2014-06-06","description":"gpASIT+TM product is based on highly purified allergen fragments obtained from grass pollen. The purpose of this clinical trial is to confirm the safety, clinical tolerability and immunogenicity of increasing doses of gpASIT+TM administered subcutaneously to patients with grass pollen-induced allergic rhinoconjunctivitis, and to determine the maximal tolerated dose of gpASIT+TM .","other_id":"BTT-gpASIT007","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Signed and dated Informed Consent Form by a legally competent patient\r\n\r\n          -  Female or male patients aged 18-70 years\r\n\r\n          -  The patients are in good physical and mental health according to his/her medical\r\n             history and vital signs\r\n\r\n          -  Non-pregnant, non-lactating females with adequate contraception\r\n\r\n          -  Females unable to bear children must have signed the form for adequate contraceptive\r\n             protection (i.e. tubule ligation, hysterectomy, or post-menopausal (defined as a\r\n             minimum of one year since the last menstrual period))\r\n\r\n          -  Allergy diagnosis:\r\n\r\n               -  A medical history of moderate to severe seasonal allergic rhinoconjunctivitis\r\n                  (SAR) for the grass pollen season during at least the two previous years\r\n\r\n               -  A positive skin prick test (wheal diameter  3 mm) to grass-pollen mixture,\r\n                  histamine wheal  3 mm, NaCl control reaction  2 mm\r\n\r\n               -  Specific IgE against grass pollen (IgE > 0.7 kU/l)\r\n\r\n               -  Patients treated with anti-allergic medication for at least 2 years prior to\r\n                  enrolment\r\n\r\n          -  In asthmatic patients:\r\n\r\n               -  Confirmed diagnosis of controlled asthma according to GINA-guidelines (GINA 2011)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Simultaneous participation in other clinical trials or previous participation within\r\n             30 days before inclusion\r\n\r\n          -  Previous immunotherapy with grass allergens within the last 5 years\r\n\r\n          -  Ongoing immunotherapy\r\n\r\n          -  Patients being in any relationship or dependence with the Sponsor and/ or Investigator\r\n\r\n          -  Inability to understand instructions/ study documents\r\n\r\n          -  Patients with a history of hypersensitivity to the excipients of investigational\r\n             products\r\n\r\n          -  Patients with partly controlled or uncontrolled asthma\r\n\r\n          -  Chronic asthma or emphysema, particularly with a FEV 1 <80% of the predicted value\r\n             (ECSC)\r\n\r\n          -  Patients symptomatic to perennial inhalant allergens to which the subjects are\r\n             regularly exposed\r\n\r\n          -  Patients with a history of ragweed allergy\r\n\r\n          -  Patients with a history of renal disease or chronic hepatic disease\r\n\r\n          -  Patients with malignant disease\r\n\r\n          -  Patients with a know severe autoimmune disease and patients with a positive test to\r\n             ANA, ANCA or ASCA\r\n\r\n          -  Patients with any chronic disease which may impair the patient's ability to\r\n             participate in the trial (i.e. severe congestive heart failure, active gastric ulcer,\r\n             inflammatory bowel disease, uncontrolled diabetes mellitus, etc)\r\n\r\n          -  Patients requiring beta-blockers/ACE-inhibitors medication\r\n\r\n          -  Patients requiring anti-IgE antibodies, mast cell stabilizers, and antileukotriene\r\n             agents\r\n\r\n          -  Patients with any contraindication for the use of adrenaline\r\n\r\n          -  Patients with febrile illness (> 37.5C, oral)\r\n\r\n          -  Patients with a known positive serology for HIV-1/2, HBV or HCV\r\n\r\n          -  Patients who are immunocompromised by medication or illness, have received a vaccine\r\n             corticoids or immunosuppressive medications within 1 month before trial entry\r\n\r\n          -  Female patients who are pregnant, lactating, or of child-bearing potential and not\r\n             protected from pregnancy by a sufficiently reliable method\r\n\r\n          -  Consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 3\r\n             weeks preceding the trial (screening visit)\r\n\r\n          -  Patients with laboratory values greater than grade 1 according to the FDA Guidance for\r\n             Industry for preventive Vaccine Trials (FDA 2007)\r\n\r\n          -  Unreliable patients including non-compliant patients, patients with known alcoholism\r\n             or drug abuse or with a history of a serious psychiatric disorder as well as patients\r\n             unwilling to give informed consent or to abide by the requirements of the protocol\r\n      ","sponsor":"BioTech Tools S.A.","sponsor_type":"Industry","conditions":"Hay Fever","interventions":[{"intervention_type":"Biological","name":"Biological: gpASIT+TM"}],"outcomes":[{"outcome_type":"primary","measure":"(Serious) adverse events","time_frame":"Up to 6 weeks"},{"outcome_type":"secondary","measure":"Grass pollen allergen -specific immunoglobulins","time_frame":"up to 6 weeks"},{"outcome_type":"secondary","measure":"Blocking antibody production","time_frame":"up to 6 weeks"},{"outcome_type":"secondary","measure":"Change from baseline in Conjunctival Provocation Test score","time_frame":"at screening, after 4 weeks and 6 weeks of treatment"},{"outcome_type":"secondary","measure":"Local reaction at the injection site","time_frame":"up to 6 weeks"},{"outcome_type":"secondary","measure":"Systemic reaction after injection","time_frame":"up to 6 weeks"},{"outcome_type":"secondary","measure":"Change from baseline in safety laboratory parameters","time_frame":"up to 6 weeks"}]}
{"nct_id":"NCT01948505","start_date":"2013-08-31","phase":"Phase 4","enrollment":210,"brief_title":"Effect of IV Acetaminophen on Patients in the Neurocritical Care Unit","primary_completion_date":"2016-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-11-30","last_update":"2016-12-09","description":"To assess the efficacy of an intravenous nonnarcotic pain medication on controlling patient pain. To assess the effect of an intravenous nonnarcotic pain medication on patient sedation levels in neurocritically ill patients. To assess the effect of an intravenous nonnarcotic pain medication on common side effects seen in patients taking other intravenous narcotic pain medication in the neurocritical care unit.","other_id":"00061838","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":90,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  > 45 kg (amenable to adult dosing)\r\n\r\n          -  all traumatic brain injuries NPO for at least 12 hours\r\n\r\n          -  all post-operative craniotomy patients\r\n\r\n          -  all non-operative subarachnoid hemorrhage, intraparenchymal hemorrhage, and stroke\r\n             patients\r\n\r\n          -  all carotid endarterectomy and carotid artery stenosis patients\r\n\r\n          -  all endovascular patients undergoing intracranial intervention\r\n\r\n          -  all post-op spine patients admitted to the NCCU\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  documented allergy to acetaminophen\r\n\r\n          -  documented severe hepatic impairment (Child-Pugh score > 6) or severe hepatic disease\r\n             (hepatitis)\r\n\r\n          -  documented severe renal impairment (CrCl < 30 ml/min) Blood tests will be performed\r\n             prior to study procedures that will ensure patients do not have renal impairment.\r\n\r\n          -  patients who are pregnant or breast feeding\r\n      ","sponsor":"University of Utah","sponsor_type":"Other","conditions":"Post-operative Craniotomy Patients|Carotid Endarterectomy and Carotid Artery Stenosis Patients|Post-op Spine Patients Admitted to the NCCU|Endovascular Patients Undergoing Intracranial Intervention|Traumatic Brain Injuries NPO for at Least 12 Hours","interventions":[{"intervention_type":"Drug","name":"Drug: Intravenous acetaminophen"},{"intervention_type":"Drug","name":"Drug: Placebo for IV acetaminophen"}],"outcomes":[{"outcome_type":"primary","measure":"Level of pain as measured on the 0-10 Numeric Rating Scale (NRS)","time_frame":"48 hours"},{"outcome_type":"secondary","measure":"Sedation level as measured on the Riker Scale (1-7)","time_frame":"48 hours"},{"outcome_type":"other","measure":"Frequency of nausea, vomiting, urinary retention & constipation","time_frame":"48 hours"}]}
{"nct_id":"NCT01835470","start_date":"2013-08-09","phase":"Phase 3","enrollment":23,"brief_title":"Efficacy, Safety, Pharmacokinetics and Immunogenicity Study of Abatacept Administered Intravenously to Treat Active Polyarticular-course Juvenile Idiopathic Arthritis in Japan","official_title":"A Phase III, Multicenter, Open-Label Study to Assess Efficacy, Safety, Pharmacokinetics and Immunogenicity of Abatacept Administered Intravenously in Japanese Children and Adolescents With Active Juvenile Idiopathic Arthritis Who Have a History of an Inadequate Response or Intolerance to Methotrexate or Biologics","primary_completion_date":"2015-11-24","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-07-30","last_update":"2021-02-26","description":"The purpose of this study is to assess the efficacy of Abatacept after intravenous administration in Japanese children and adolescents with active juvenile idiopathic arthritis who have a history of an inadequate response or intolerance to Methotrexate or biologics","other_id":"IM101-365","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":4,"maximum_age":17,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subjects who have a history of an inadequate therapeutic response or intolerance in\r\n             the opinion of the examining physician to at least one biologics or Methotrexate\r\n             (MTX).\r\n\r\n          -  Diagnosis of Juvenile Idiopathic Arthritis (JIA) by International League of\r\n             Associations for Rheumatology (ILAR) criteria as oligoarticular, polyarticular\r\n             Rheumatoid Factor (RF+), polyarticular (RF-), or systemic with a polyarticular-course.\r\n\r\n          -  Men and women, ages 4 to 17 years, inclusive at enrollment.\r\n\r\n          -  Subjects must have a history of at least 5 joints with active disease and must have\r\n             currently active articular disease as defined by:\r\n\r\n               1. 2 active joints (e.g. presence of swelling, or if no swelling is present,\r\n                  limitation of motion (LOM) accompanied by pain, tenderness, or both) at screening\r\n                  and at Week 0 (Day 1).\r\n\r\n               2. 2 joints with LOM at screening and at Week 0 (Day 1).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Systemic onset JIA with any of the following manifestations within the last 6 months\r\n             prior to enrollment: intermittent fever due to JIA, rheumatoid rash,\r\n             hepatosplenomegaly, pleuritis, pericarditis, or macrophage activation syndrome.\r\n\r\n          -  Presence of any other rheumatic disease or major chronic\r\n             infectious/inflammatory/immunologic disease (e.g. inflammatory bowel disease,\r\n             psoriatic arthritis, spondyloarthropathy, hypogammaglobulinemia, or systemic lupus\r\n             erythematosus, etc.)\r\n      ","sponsor":"Bristol-Myers Squibb","sponsor_type":"Industry","conditions":"Juvenile Idiopathic Arthritis","interventions":[{"intervention_type":"Drug","name":"Drug: Abatacept"}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of Participants Experiencing a American College of Rheumatology (ACR) Pediatric 30 Response at Week 16","time_frame":"Week 16 (Day 113)","description":"American College of Rheumatology (ACR) pediatric (PED) 30 response was defined as '≥30% improvement' and '≥3 of the 6 Juvenile Idiopathic Arthritis (JIA) core set' and ≥30% worsening in not more than 1 of the 6 JIA core set variables. JIA core set variables defined as the number of active joints, number of joints with Limit of Motion (LOM), physician's global assessment of disease severity, patient global assessment of overall well being, parent assessment of physical function, and acute phase reactant value. A non-responder imputation was applied."},{"outcome_type":"secondary","measure":"Percentage of Participants Experiencing a American College of Rheumatology Pediatric 50, 70, 90 Response or Inactive Disease at Week 16","time_frame":"Week 16 (Day 113)","description":"ACR PED 50 response is defined as '≥50% improvement' and '≥3 of the 6 Juvenile Idiopathic Arthritis (JIA) core set' and ≥30% worsening in not more than 1 of the 6 JIA core set variables. ACR PED 70 response is defined as '≥70% improvement' and '≥3 of the 6 JIA core set' and ≥30% worsening in not more than 1 of the 6 JIA core set variables. ACR PED 90 response is defined as '≥90% improvement' and '≥3 of the 6 JIA core set' and ≥30% worsening in not more than 1 of the 6 JIA core set variables. Inactive disease status is defined as no active joints, physician's global assessment of disease severity equal or less than 10mm and C-reactive protein (CRP) within normal limits (0.3 mg/dL). A non-responder imputation is applied. mm=millimeter; mg/dL=milligrams/deciliter"},{"outcome_type":"secondary","measure":"Median Percentage of Improvement From Baseline in Physical Function as Assessed by the Childhood Health Assessment Questionnaire (CHAQ) Disability Index at Week 16","time_frame":"Week 16 (Day 113)","description":"Physical function was evaluated using the disability section of the Childhood Health Assessment Questionnaire (CHAQ). The questionnaire was derived from the adult HAQ. The disability section assessed physical functions in 8 domains: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities. The questions were evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty and 3 =unable to do. Higher scores indicate greater dysfunction. A disability index was calculated as the mean of the 8 functional scales. The percentage of Improvement from baseline was calculated using the following equation: (Baseline value - Post-baseline value) / Baseline value x 100."},{"outcome_type":"secondary","measure":"Number of Participants With Death, Serious Adverse Events (SAEs), Drug-Related SAEs, Discontinuation Due to Drug-Related SAEs, Drug-Related Adverse Events (AEs), and Discontinuation Due to Drug-Related AEs During the Short Term Period","time_frame":"Day 1 up to 56 days post Week 16 (Day 113); approximately 6 months","description":"AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. SAEs also include hospitalizations for elective surgical procedures. Drug-related=related or missing relationship to study drug. Data includes all events from the date of the first dose of the study drug up to 56 days post the last dose of the study drug in the short-term period or start of the long-term period, whichever occurred first."},{"outcome_type":"secondary","measure":"Maximum Observed Concentration (Cmax) of Abatacept During the Short Term Period","time_frame":"9 time points up to Week 16 (Day 113)","description":"Cmax was obtained from the serum concentration versus time data after intravenous administration of abatacept. Blood samples were collected at 0 hour (pre-dose) on Days 15 and 29 and at 0 hour (pre-dose) and 0.5 hours (post dose) on Days 57, 85, and 113. A blood sample was also collected on an interim visit that occurred on any day between Day 92 and Day 110. ug/mL=micrograms/milliliter"},{"outcome_type":"secondary","measure":"Trough Observed Concentration (Ctrough) of Abatacept During the Short Term Period","time_frame":"9 time points up to Week 16 (Day 113)","description":"Blood samples were collected at 0 hour (pre-dose) on Days 15 and 29 and at 0 hour (pre-dose) and 0.5 hours (post dose) on Days 57, 85, and 113. A blood sample was also collected on an interim visit that occurred on any day between Day 92 and Day 110. ug/mL=micrograms/milliliter"},{"outcome_type":"secondary","measure":"Number of Participants With Positive Immunogenicity During the Short Term Period","time_frame":"Day 1 up to Week 16 (Day 113)","description":"A positive immunogenicity response for 'Cytotoxic T-lymphocyte antigen (CTLA4), Immunoglobulin (Ig)', 'Ig and/or Junction Region', respectively = (1) missing baseline immunogenicity measurement and positive analytical laboratory reported immunogenicity response post-baseline (2) negative baseline immunogenicity response and positive analytical laboratory reported immunogenicity response post-baseline (3) positive baseline immunogenicity response and positive analytical laboratory reported immunogenicity response post-baseline with titer value strictly greater than the baseline titer value. Assessment based on assay cutpoint value. Serum samples were collected prior to study medication at Week 0 (Day 1), Week 8 (Day 57), and Week 16 (Day 113) in the short term period. Participants who early discontinued from the study or complete and did not switch to commercial abatacept had a serum sample collected on final visit or early termination visit, 28, 84 and 168 days after the last dose."}]}
{"nct_id":"NCT02508090","start_date":"2013-08-02","enrollment":10,"brief_title":"Long-Term Extension Study of Miravirsen Among Participants With Genotype 1 Chronic Hepatitis C (CHC) Who Have Not Responded to Pegylated-Interferon Alpha Plus Ribavirin","official_title":"Long-Term Extension to a Phase 2, Open-Label, Clinical Trial of Miravirsen Sodium in Null Responders to Pegylated-Interferon Alpha Plus Ribavirin in Subjects With Chronic Hepatitis C (CHC) Virus Genotype 1 Infection","primary_completion_date":"2017-01-13","study_type":"Observational","rec_status":"Completed","completion_date":"2017-01-13","last_update":"2017-11-01","description":"Genotype 1 CHC participants from Study SPC3649-207 with null response to prior pegylated-interferon alpha plus ribavirin will be enrolled into this 36-month extension study, designed to evaluate the long-term safety and efficacy after 12 weeks of miravirsen monotherapy. Due to the observational nature of the study, miravirsen will not be dosed as an investigational product.","other_id":"NP29711","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","population":"This study will enroll null responders with CHC genotype 1 virus infection who have\r\n        participated in Study SPC3649-207.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Participants from Study SPC3649-207, including those who completed the study and those\r\n             who discontinued or terminated the study early for any reason, or those who opted to\r\n             receive other approved therapy for the treatment of hepatitis C virus (HCV) infection\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Participants who have received investigational drug therapy after discontinuation,\r\n             termination, or completion of Study SPC3649-207\r\n      ","sponsor":"Hoffmann-La Roche","sponsor_type":"Industry","conditions":"Chronic Hepatitis C","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Incidence of adverse events","time_frame":"Up to 36 months"},{"outcome_type":"primary","measure":"Incidence of sustained virologic response (SVR)","time_frame":"48 weeks after end of treatment (EOT)"},{"outcome_type":"primary","measure":"Change from Baseline in HCV ribonucleic acid (RNA) level","time_frame":"Up to 36 months"},{"outcome_type":"primary","measure":"Incidence of HCV resistance","time_frame":"Up to 36 months"}]}
{"nct_id":"NCT01946672","start_date":"2013-07-31","phase":"Phase 4","enrollment":55,"brief_title":"Lower-Limb Drainage Mapping in Pelvic Lymphadenectomy for Gynaecological Cancer","official_title":"Individualisation du Drainage Lymphatique Des Membres infrieurs Lors du Curage Pelvien Pour Cancer gyncologique","primary_completion_date":"2020-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2020-12-31","last_update":"2017-12-21","description":"The purpose of this study is to evaluate the feasibility of an isotopic technique to identify, and to map the lower-limb drainage nodes during pelvic lymphadenectomy for gynaecological cancers. The diagnostic value of our mapping method will be assessed, and we will determine the incidence of lymhedema.","other_id":"P110903","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Female patients 18 years of age or older with indication of pelvic lymphadenectomy for\r\n             gynaecological malignancy:\r\n\r\n               -  High risk endometrial cancer (stage IB type I grade 3, stage I type II, stage>\r\n                  IB) or with metastatic sentinel lymph node,\r\n\r\n               -  Early cervical cancer, or with metastatic sentinel lymph node,\r\n\r\n               -  Ovarian cancer.\r\n\r\n          -  Must provide her signed and informed consent\r\n\r\n          -  Beneficiary of a health insurance\r\n\r\n          -  Having received a medical examination\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Contraindication to pelvic lymphadenectomy\r\n\r\n          -  Presence of lymphedema of the lower limbs\r\n\r\n          -  Contraindication to radiomarkers (allergy or hypersensitivity to any component of the\r\n             biomarker)\r\n\r\n          -  Patient with dementia or altered mental status\r\n\r\n          -  Pregnant or breast feeding patients\r\n\r\n          -  Participation in any other clinical trial that could interfere with the study results\r\n      ","sponsor":"Assistance Publique - Hpitaux de Paris","sponsor_type":"Other","conditions":"Gynaecological Malignant Tumours With Indication of Pelvic Lymphadenectomy","interventions":[{"intervention_type":"Procedure","name":"Procedure: Lower-limb drainage isotopic intraoperative detection","description":"A radiopharmaceutical is injected into both feet on the day before surgery. Pelvic lower-limb drainage nodes (LLDNs) are identified using preoperative SPECT-CT and intraoperative isotopic probe detection, and then electively removed before complete pelvic lymphadenectomy. LLDNs and pelvic lymphadenectomy specimens undergo separate histological analysis."}],"outcomes":[{"outcome_type":"primary","measure":"Lower-limb drainage intraoperative isotopic detection rate in patients with pelvic lymphadenectomy for gynaecological cancers.","time_frame":"day of surgery"},{"outcome_type":"secondary","measure":"Anatomy of lower-limb drainage","time_frame":"day of surgery"},{"outcome_type":"secondary","measure":"Percentage of patients with metastatic lower limb sampling","time_frame":"2 weeks after surgery"},{"outcome_type":"secondary","measure":"Follow-up of patients to identify complications, and namely lower-limb lymphedema.","time_frame":"5 years"}]}
{"nct_id":"NCT01733888","start_date":"2013-07-31","phase":"N/A","enrollment":80,"brief_title":"Resin Infiltration and Resin Infiltration With Bleaching in Improving the Esthetics for Fluorosis Stains","official_title":"Evaluating the Effect of Resin Infiltration and Resin Infiltration With Bleaching in Improving the Esthetics for Non Pitted Fluorosis Stains in Indian Population","primary_completion_date":"2013-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-05-31","last_update":"2014-06-23","description":"Dental fluorosis is a clinical manifestation of chronic exposure to high intakes of fluoride during the tooth development. The present study is planned to evaluate the efficacy of Resin Infiltration technique in improving the esthetics of non-pitted fluorosis stains on permanent anterior teeth. Resin infiltration is a novel method that has shown its efficacy in improving the esthetics of White spot lesions (WSLs) per say and post orthodontics WSLs in different both in-situ and in-vivo studies. The Resin Infiltration technique is also known to stop the progression of caries in non cavitated lesions in both, smooth surface and interproximal lesions. Therefore, the following trial will be conducted to assess the esthetic improvement of fluorosed permanent anterior teeth after resin infiltration and compare it with standard bleaching procedure and a combination of bleaching and Resin infiltration therapy in children with damaged teeth by fluorosis.","other_id":"FLUORIC","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":6,"maximum_age":12,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Only the non-pitted Fluorosis opacities shall be included for this purpose; opacities\r\n             in anterior teeth shall be classified according to Russell's criteria for\r\n             differentiating fluoride and non- fluoride opacities\r\n\r\n          -  Subjects classified /Teeth classified with dental fluorosis of 1-4 according to\r\n             Thylstrup, Fejerskov classification of dental fluorosis 20\r\n\r\n          -  Patients who will be willing to participate in the study and who will be accepting for\r\n             recall visit.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of allergy towards any dental material.\r\n\r\n          -  Teeth classified as non-fluoride opacities\r\n\r\n          -  Subjects with any systemic and local conditions not permitting the treatment\r\n\r\n          -  Subjects who had undergone any treatment for dental fluorosis earlier\r\n\r\n          -  Subjects with direct or indirect restorations in maxillary central or lateral\r\n             incisors.\r\n\r\n          -  Subjects not willing to participate in the study\r\n\r\n          -  Subjects with fractured teeth maxillary central or lateral incisors.\r\n      ","sponsor":"DMG Dental Material Gesellschaft mbH","sponsor_type":"Industry","conditions":"Caries Infiltration|Fluorosis|Dental Care","interventions":[{"intervention_type":"Device","name":"Device: Office Bleaching with 35 % Hydrogen Peroxide","description":"In this group before starting the procedure the teeth intended to be treated will be cleaned with pumice and after that cheek retractors will be placed and exposed lip surface will be covered with petroleum gel. Thereafter, teeth will be dried and gingival Barrier will be applied to both arches, slightly overlapping enamel and interproximal spaces. Light curing of the gingival barrier will be done in a fanning motion for 10-20 seconds . Once the gingival barrier will be cured then homogeneous mixing of the powder and liquid will be done in powder pot, followed by application of thick layer of gel to all teeth undergoing treatment. The gel will be then left in place for 8 minutes and after that the gel will be removed using a surgical aspirator tip."},{"intervention_type":"Device","name":"Device: Icon Infiltration","description":"In this group after taking pre-operative photographs the fluorosed tooth will be isolated using rubber dam and the Resin infiltrant (Icon, DMG, Hamburg, Germany) will be applied as per manufactures' instructions. For this purpose, after rubber dam application tooth surface will be dried using cotton rolls and air syringe. Icon Etchant will be applied and left for 2 minutes followed by rinsing and air drying for 30 sec. After complete etching, Drying agent (99% ethanol), as supplied in the Icon kit. Resin infiltrant will then be applied and allowed to seep in for 3 minutes followed by light curing for 40 seconds followed by cleaning of the surface with pumice and rubber polishing cup and rinsing with water for 30 sec. After application, patient will be instructed neither to eat nor brush their teeth for 45 minutes."},{"intervention_type":"Device","name":"Device: Icon Infiltration twice","description":"In this group application of the resin infiltration shall be done similar to the procedure as explained for intervention \"Icon infiltration\", but the resin infiltrant shall be applied twice."},{"intervention_type":"Device","name":"Device: Bleaching+Icon Infiltration","description":"In this group vital bleaching will be done using 35 % Hydrogen Peroxide (Pola Office, SDI, Australia), as explained in intervention \"bleaching\"; followed by wash over period of 20 days. After 20 days the patient will be recalled and on the day of appointment initially a new preoperative photograph shall be taken, then the fluorosed tooth will be isolated using rubber dam and the Resin infiltrant (Icon, DMG, Hamburg, Germany) will be applied as per manufactures' instructions, similar to intervention \"Icon Infiltration\". For this group a postoperative photograph shall be taken after the application of RI and then the circle of post-operative recall shall be counted from here, that is, 1week, 1 month and 6 months respectively."}],"outcomes":[{"outcome_type":"primary","measure":"pre-treatment and post-treatment colour changing (L*A*B values) of digital photographs of fluorosed teeth of all the four groups","time_frame":"6 month"},{"outcome_type":"secondary","measure":"pre-treatment esthetic perception by the subjects of their fluorosed teeth","time_frame":"6 month"},{"outcome_type":"secondary","measure":"post-treatment patient satisfaction using the Patient satisfaction scale","time_frame":"1 week"}]}
{"nct_id":"NCT01967875","start_date":"2013-07-31","phase":"Phase 2","enrollment":27,"brief_title":"A Phase 2 Trial of Optimizing Platinum-Based Chemotherapy Based on ERCC1 Expression as First-Line Treatment in Patients With Locally Advanced or Metastatic Gastric Cancer","official_title":"A Prospective, Multi-Center, Randomized Control Phase 2 Trial of Optimizing Platinum-Based Chemotherapy Based on ERCC1 Expression as First-Line Treatment in Patients With Locally Advanced or Metastatic Gastric Cancer","primary_completion_date":"2015-05-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2016-05-31","last_update":"2019-05-30","description":"The purpose of this study is to determine whether ERCC1(excision repair cross-complementation 1 ) expression has effects on platinum-based chemotherapy for patients with locally advanced or metastatic gastric cancer, and to explore if ERCC1 can act as a biological predictor for the individual therapy of gastric cancer","other_id":"CLOG1301","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18yAge65y, male or female\r\n\r\n          -  KPS70\r\n\r\n          -  Histologically confirmed adenocarcinoma of the stomach or gastro-oesophageal junction\r\n             with inoperable locally advanced or recurrent and/or metastatic disease\r\n\r\n          -  At least one measurable lesion, according to the Response Evaluation Criteria in Solid\r\n             Tumors (RECIST 1.1), assessed using imaging techniques (CT or MRI)\r\n\r\n          -  No prior anti-tumor treatment or an interval of at least 6 months from the last\r\n             adjuvant chemotherapy, and an interval of at least 4 weeks from the last radical\r\n             radiation therapy\r\n\r\n          -  No major organ disorder, with normal liver, kidney and heart function\r\n\r\n          -  Laboratory test must meet the following criteria: hemoglobin (HGB) 90g/L, neutrophil\r\n             count 1.5109/L, platelet count 100109/L, creatinine clearance rate (CCr)\r\n             60ml/min, total bilirubin (TBil) 1.5 upper normal limitation (UNL), alanine\r\n             aminotransferase (ALT) and aspartate aminotransferase (AST) 2.5 UNL (For patients\r\n             with liver metastasis, the AST/ALT must be 5.0 UNL), blood glucose 11.1 mmol/L\r\n\r\n          -  Life expectancy of at least 12 weeks\r\n\r\n          -  Signed informed consent\r\n\r\n          -  For women with child bearing potential, a negative serum or urine pregnancy test\r\n             result should be obtained before enrollment\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Progression from prior palliative treatment with capecitabine- or docetaxel-based\r\n             regimen\r\n\r\n          -  Serious uncontrolled systemic illness or medical condition: congestive heart failure,\r\n             unstable angina, history of documented myocardial infarction within 6 months,\r\n             uncontrolled hypertension and high risk uncontrollable arrhythmias; Obvious\r\n             neurological or mental abnormalities including mental disorder, epileptic dementia,\r\n             which affect compliance; Uncontrolled acute infections; Uncontrolled peptic ulcer,\r\n             diabetes or other contraindication for corticosteroid therapy\r\n\r\n          -  Inability to take or absorb oral medicine\r\n\r\n          -  Concurrent administration of any other investigational drug, or have been enrolled in\r\n             other clinical trial with investigational drug treatment within the 30 days of start\r\n             of study treatment\r\n\r\n          -  Presence of neuropathy grade 1 according to NCI-CTCAE V4.0\r\n\r\n          -  Hypersensitivity or known or suspicious allergic to any of the study drugs\r\n\r\n          -  Pregnant or lactated women\r\n\r\n          -  Unsuitable for the study or other chemotherapy determined by investigator\r\n      ","sponsor":"China Medical University, China","sponsor_type":"Other","conditions":"Stomach Neoplasms","interventions":[{"intervention_type":"Drug","name":"Drug: Capecitabine+Cisplatin","description":"Cisplatin 75mg/m2, d1; Capecitabine 1700-2000mg/m2/day on days1-14 every 21 days, 6 cycles.Capecitabine is to be continued until disease progression or intolerable toxicity."},{"intervention_type":"Drug","name":"Drug: Docetaxel+Capecitabine","description":"Docetaxel 75mg/m2, d1; Capecitabine 1700-2000mg/m2/day on days1-14 every 21 days, 6 cycles. Capecitabine is to be continued until disease progression or intolerable toxicity."}],"outcomes":[{"outcome_type":"primary","measure":"Progression-Free Survival (PFS)","time_frame":"2 years"},{"outcome_type":"secondary","measure":"Overall Survival(OS)","time_frame":"2 years"},{"outcome_type":"secondary","measure":"Objective Response Rate(ORR),Including Complete Response(CR) and Partial Response(PR)","time_frame":"2 years"},{"outcome_type":"secondary","measure":"Disease Control Rate(DCR), Including Complete Response(CR) , Partial Response(PR) and Stable Disease(SD)","time_frame":"2 years"},{"outcome_type":"secondary","measure":"Duration of Response","time_frame":"2 years"},{"outcome_type":"secondary","measure":"Safety(number and degree of adverse events)","time_frame":"2 years"},{"outcome_type":"secondary","measure":"Quality of Life(QOL)","time_frame":"2 years"}]}
{"nct_id":"NCT02119403","start_date":"2013-07-31","phase":"N/A","enrollment":250,"brief_title":"Hand Held Nitrous Oxide Delivery Device","official_title":"Safety and Efficacy of Hand Held Nitrous, a Device That Delivers 16 Grams of Nitrous Oxide Over 120 Seconds of Inhalation Time.","primary_completion_date":"2014-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2014-12-31","last_update":"2014-04-21","description":"To study the safety and efficacy of Hand Held Nitrous. A device that delivers 120 seconds of up to 72% nitrous oxide and ambient air.","other_id":"smi7531","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":3,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Any patient undergoing a painful office procedure or exam\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Women that are Pregnant\r\n\r\n          -  Children under three years of age\r\n      ","sponsor":"Strata Medical Innovations","sponsor_type":"Industry","conditions":"Anesthesia","interventions":[{"intervention_type":"Other","name":"Other: There are no other inteventions.","description":"This device gives patients the opportunity to receive nitrous oxide where no such opportunity exists. There is no other intervention available that creates immediate short term minimal sedation."}],"outcomes":[{"outcome_type":"primary","measure":"This study measures the types of complications (if any) associated with the use of small set amount of nitrous oxide.","time_frame":"The patient is under observation for the length of the procedure or until baseline parameters are met (under 10 minutes). No followup is required.","description":"This is a short acting device that delivers a small amount of nitrous oxide. The patient responds quickly and recovers quickly (approximately 6 minutes)."}]}
{"nct_id":"NCT02395913","start_date":"2013-07-31","phase":"Phase 1","enrollment":72,"brief_title":"Compare Safety and Pharmacokinetic Properties of Surfolase Capsule(Acebrophylline 100mg) and Surfolase CR(200mg)","primary_completion_date":"2013-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-09-30","last_update":"2015-03-24","description":"Acebrophylline is metabolized by being separated into Ambroxol and 7-theophylline when orally administered as a salt composed of an acid-base as a compound that was synthesized by and chloride (salifying) the ambroxol to 7-theophylline. Acebrophylline is selectively applied to the bronchial or lung tissue and inhibit the activity of phospholipase bronchoalveolar shows the expectorant action to raise the surface activity of the alveolar, leukotrienes (LTs) and by suppressing the production of prostaglandins (PGs), showed potent anti-inflammatory activity, bronchial was celebrated by reducing the bronchial hyperreactivity to normal state is allowed to recuperate or extended. It was developed to improve compliance improve pharmaceutically Surfolase capsule(Acebrophylline 100mg) that intake twice daily 100mg to Surfolase CR(Acebrophylline 200mg) that intake once daily 200mg","other_id":"HT-002-02","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":20,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Healthy male subjects between the ages of 20 and 55 years, BMI >18.5, <25, inclusive\r\n\r\n             *Body mass index (kg/m2) = weight(kg)/height(m)2\r\n\r\n          2. Subject who don't have congenital or chronic diseases and have no abnormal medical\r\n             examination results.\r\n\r\n          3. Subject is healthy (no clinically relevant findings in any of the investigations of\r\n             the pre-examination) as judged by the investigator\r\n\r\n          4. Subjects who signed and dated in informed consent form indicating that the subject has\r\n             decided to participate in the study after being informed of all pertinent aspects of\r\n             the study\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Subject with known for hypersensitivity reaction to acebrophylline, xanthine and food.\r\n\r\n          2. Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency\r\n             or glucose-galactose malabsorption\r\n\r\n          3. Subject with serious active cardiovascular, respiratory, hepatologic, renal,\r\n             hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological\r\n             disease or history of such disease\r\n\r\n          4. Subject with known for history of gastrointestinal disease or gastrointestinal surgery\r\n             which affect on the absorption drug\r\n\r\n          5. Subjects with any of the following condition in screening (blood pressure, 12-lead\r\n             ECG, blood, urinalysis, etc.)\r\n\r\n          6. Subject with any of the following conditions in laboratory test i. AST(sGOT) or\r\n             ALT(sGPT) > Upper normal limit  1.25 ii. Total bilirubin > Upper normal limit  1.5\r\n\r\n          7. If the estimated GFR < 80mL/min/1.76m2 using MDRD formula.\r\n\r\n          8. Systolic blood pressure <=90mmHg or diastolic blood pressure >=150mmHg or a person\r\n             showing the corresponding figures <=50mmHg or >=100mmHg in vital signs.\r\n\r\n          9. Who has history of drug abuse (especially hypnotic, central acting analgesics,\r\n             psychotropic drugs, such as opiates or central nervous system acting drug) or shows\r\n             positive reactions to drug of abuse in urine drug screening tests.\r\n\r\n         10. Excessive caffeine and alcohol intake, smoking person(caffeine: > 5cups/day, alcohol:\r\n             >210g/week, tobacco: > 10 cagarettes/day)\r\n\r\n         11. Use of any prescription medication within 14 days prior to study medication dosing or\r\n             use of any medication such as over-the-counter medication including oriental\r\n             medication within 7 days prior to study medication dosing\r\n\r\n         12. Participation in any clinical investigation within 60days prior to study medication\r\n             dosing\r\n\r\n         13. Subjects with whole blood donation within 60days, component blood donation within\r\n             30days\r\n\r\n         14. Subjects with decision of nonparticipation through investigator's review due to\r\n             laboratory test results or other excuse such as non-responding to request or\r\n             instruction by investigator\r\n      ","sponsor":"Hyundai Pharmaceutical Co., LTD.","sponsor_type":"Industry","conditions":"Healthy Male","interventions":[{"intervention_type":"Drug","name":"Drug: Surfolase capsule (100mg)","description":"Surfolase capsule one capsule twice one days fasting administration"},{"intervention_type":"Drug","name":"Drug: Surfolase CR (200mg, T1)","description":"one tablet once one days fasting administration."},{"intervention_type":"Drug","name":"Drug: Surfolase CR (200mg, T3)","description":"one tablet once one days fasting administration."},{"intervention_type":"Drug","name":"Drug: Surfolase CR (200mg, T4)","description":"one tablet once one days fasting administration."}],"outcomes":[{"outcome_type":"primary","measure":"AUCt of ambroxol","time_frame":"blood serum sampling"},{"outcome_type":"primary","measure":"Cmax of ambroxol","time_frame":"blood serum sampling"},{"outcome_type":"secondary","measure":"AUCinf of ambroxol","time_frame":"blood serum sampling"},{"outcome_type":"secondary","measure":"Tmax of ambroxol","time_frame":"blood serum sampling"},{"outcome_type":"secondary","measure":"t1/2 of ambroxol","time_frame":"blood serum sampling"}]}
{"nct_id":"NCT01872065","start_date":"2013-07-31","phase":"Phase 1","enrollment":54,"brief_title":"Safety and Tolerability Study of ARC-520 in Healthy Volunteers","official_title":"A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ARC-520 in Normal Adult Volunteers","primary_completion_date":"2014-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-11-30","last_update":"2014-12-10","description":"The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of ARC-520 in normal, adult volunteers.","other_id":"Heparc-1001","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Key Inclusion Criteria:\r\n\r\n          -  Healthy male or female subjects, 18-55 years of age\r\n\r\n          -  Be a non-smoker\r\n\r\n        Key Exclusion Criteria:\r\n\r\n          -  History of clinically relevant medical illnesses that in the Investigator opinion may\r\n             jeopardize subject safety or interfere with participation in the study, including but\r\n             not limited to hematological, renal, endocrine, pulmonary, gastrointestinal,\r\n             cardiovascular, hepatic, psychiatric, neurologic, or allergic disease\r\n\r\n          -  Acute signs of hepatitis/other infection (e.g., moderate fever, jaundice, nausea,\r\n             vomiting, abdominal pain) evident within 4 weeks of screening and/or at the screening\r\n             examination.\r\n\r\n          -  Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days\r\n             prior to administration of study treatment.\r\n\r\n          -  Is sero-positive for HIV, HBV, HCV, and/or a history of delta virus hepatitis.\r\n\r\n          -  Currently uses and/or has a history of alcohol and/or drug abuse < 12 months from\r\n             screening.\r\n\r\n          -  Use of investigational agents or devices within 30 days prior to planned study dosing\r\n             or current participation in an investigational study.\r\n      ","sponsor":"Arrowhead Pharmaceuticals","sponsor_type":"Industry","conditions":"Healthy","interventions":[{"intervention_type":"Drug","name":"Drug: ARC-520"},{"intervention_type":"Drug","name":"Drug: Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"To determine the incidence and frequency of adverse events as a measure of safety and tolerability of ARC-520","time_frame":"One month","description":"The incidence and frequency of adverse events (AEs), serious adverse events (SAEs), related AEs, related SAEs, and AEs leading to withdrawal, dose modification, or treatment discontinuation will be summarized by dose and treatment group."},{"outcome_type":"secondary","measure":"To evaluate the pharmacokinetics of ARC-520 at different dose concentrations","time_frame":"2 days","description":"Plasma concentrations following a single dose of ARC-520 at different dose levels will be used to calculate the following ARC-520 pharmacokinetic parameters: Cmax, tmax, AUC0-24, AUCinf, and t1/2. Descriptive statistics of pharmacokinetic parameters will include mean, standard deviation, and coefficient of variation."}]}
{"nct_id":"NCT01906060","start_date":"2013-07-31","phase":"Phase 4","enrollment":1000,"brief_title":"Blind Intubation Through The Self-Pressurised Disposable Air-Q Laryngeal Intubation Mask: An International Multicentre Trial","primary_completion_date":"2016-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-06-30","last_update":"2016-06-29","description":"The disposable Air-Q self-inflating laryngeal intubation mask (Air-Q, Mercury Medical, Clearwater, FL, USA) is an extra-glottic airway device which enables blind intubation with a tracheal tube. This intubating laryngeal airway device (ILA) is already commercially available and worldwide certificated (CE 0482), but data about the success rates of blind intubation via this device in adult patients are lacking. Success rates of blind intubations with the non-self-inflating device range between 57 and 97%. Although the self-inflating disposable Air-Q device is certified for blind intubation, the success rate and rate of adverse events associated with this procedure have not been published so far. In a study comparing adverse events of conventional intubation with blind intubation via a different supra-glottic airway device (ILMA) the rates of sore throat and cough were comparable in both groups and were reported in 10-17% of the patients. In a pilot study using the non-self-inflating Air-Q for blind intubation in 19 patients, 10% reported dysphagia and one patient had a bilateral lingual nerve injury which was self-limited. One study using the self-pressurised disposable Air-Q for ventilation of children showed broncho- or laryngospasm in 3% and mucosal damage such as blood stained ILA or sore throat were reported in 1%. This data suggests that the rate of adverse events using the Air-Q supra-glottic device are comparable to other devices such as LMA. - Trial with medical device","other_id":"2013-0151","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":85,"population":"","criteria":"\n        Inclusion criteria:\r\n\r\n          -  elective surgery requiring tracheal intubation using an oral tracheal tube\r\n\r\n          -  anticipated extubation in the operating room\r\n\r\n          -  American Society of Anaesthesiologist Physical Status 1-3\r\n\r\n          -  age = 18 years and = 85 years\r\n\r\n          -  oral and written informed consent\r\n\r\n          -  weight = 100kg (according to the product description)\r\n\r\n          -  ability to understand the study information\r\n\r\n        Exclusion criteria:\r\n\r\n          -  pharyngeal, laryngeal or tracheal pathology, including tracheostomy\r\n\r\n          -  mouth opening < 2.5 cm\r\n\r\n          -  any form of airway infection such as upper-respiratory tract infection, pneumonia or\r\n             suspected tuberculosis\r\n\r\n          -  any disease that might impair the power of judgement (psychiatric disease, dementia)\r\n\r\n          -  indicated rapid sequence induction which is a standard when high risk for\r\n             regurgitation and/or aspiration is present\r\n\r\n          -  the subject must not be involved in any other clinical trial during the course of this\r\n             trial, nor within a period of 30 days prior to its beginning or 30 days after its\r\n             completion\r\n\r\n          -  pregnancy\r\n\r\n          -  breast feeding\r\n      ","sponsor":"University of Zurich","sponsor_type":"Other","conditions":"Elective Surgery Requiring Tracheal Intubation Using an Oral Tracheal Tube","interventions":[{"intervention_type":"Device","name":"Device: Air-Q Intubation Laryngeal Mask","description":"Patients will be intubated using the Air-Q Laryngeal Mask."}],"outcomes":[{"outcome_type":"secondary","measure":"Postoperative coughing after 2 hours and the next morning","time_frame":"24 hours"},{"outcome_type":"secondary","measure":"Postoperative hoarseness after 2 hours and the next morning","time_frame":"24 hours"},{"outcome_type":"secondary","measure":"Rate of blood stained devices after removal of the ILA","time_frame":"500 seconds"},{"outcome_type":"primary","measure":"Success rate of blind intubation via the disposable Air-Q self-inflating laryngeal intubation mask.","time_frame":"300 seconds","description":"Success is defined as placement of a tracheal tube into trachea with no more than two insertion attempts."},{"outcome_type":"secondary","measure":"Time for insertion of the Air-Q laryngeal mask","time_frame":"300 seconds","description":"defined as time beginning at the moment the ILA enters the mouth until the appearance of the capnography waveform"},{"outcome_type":"secondary","measure":"Time for insertion of the tube","time_frame":"300 seconds","description":"defined as the time beginning at the moment of insertion of the tube through the laryngeal mask until the appearance of the capnography waveform"},{"outcome_type":"secondary","measure":"First attempt rate and second attempt rate","time_frame":"300 seconds"},{"outcome_type":"secondary","measure":"Time for removal of the Air-Q ILA device after successful intubation","time_frame":"500 seconds"},{"outcome_type":"secondary","measure":"Rate of misplacement of the ILA","time_frame":"300 seconds"},{"outcome_type":"secondary","measure":"Rate of misplacement of the tube","time_frame":"500 seconds"},{"outcome_type":"secondary","measure":"risk factors of insertion failures","time_frame":"500 seconds"},{"outcome_type":"secondary","measure":"Rate of airway injuries","time_frame":"5 hours"},{"outcome_type":"secondary","measure":"Tightness during leak test before relaxation","time_frame":"300 seconds"},{"outcome_type":"secondary","measure":"Tightness during leak test after relaxation","time_frame":"300 seconds"},{"outcome_type":"secondary","measure":"Maximum drop of saturation during airway management","time_frame":"500 seconds"},{"outcome_type":"secondary","measure":"Rate of adverse events","time_frame":"5 hours","description":"including, but not limited to suspicion of aspiration or regurgitation (gastric fluid in the ventilation tube or hypopharynx), bronchospasm, airway obstruction, coughing, dental-, tongue-, lip- pharyngeal or laryngeal trauma"},{"outcome_type":"secondary","measure":"Rate of necessity of alternative airway device","time_frame":"500 seconds"}]}
{"nct_id":"NCT01915927","start_date":"2013-07-31","phase":"Phase 1","enrollment":20,"brief_title":"Stem Cell Fistula Plug in Perianal Crohn's Disease","official_title":"A Phase 1 Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Fistulizing Crohn's Disease.","primary_completion_date":"2019-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-12-31","last_update":"2020-01-03","description":"The investigators propose to study the safety of autologous mesenchymal stromal cell transfer using a biomatrix (the Gore Bio-A; Fistula Plug) in a Phase I study using a single dose of 20 million cells. Twenty adult patients (age 18 years or older) with refractory, complicated perianal fistulizing Crohn's disease will be enrolled. Subjects will undergo standard adjuvant therapy including drainage of infection and placement of a draining seton with continuation of pre-existing anti-Crohn's therapy. Six weeks post placement of the draining seton, the seton will be replaced with the MSC loaded Gore Bio-A fistula plug as per current clinical practice. The subjects will be subsequently followed for fistula response and closure for 24 months. This is an autologous product derived from the patient and used only for the same patient.","other_id":"12-009716","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria\r\n\r\n          -  Males and females 18-65 years of age.\r\n\r\n          -  Residents of the United States.\r\n\r\n          -  Crohn's disease with single or multiple draining complex perianal fistulae (definition\r\n             as below) for at least three months despite standard therapy (definition below).\r\n\r\n          -  Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics,\r\n             and anti-TNF therapy are permitted.\r\n\r\n          -  All patients should have undergone a colonoscopy in last 12 months to rule out\r\n             malignant or premalignant condition\r\n\r\n          -  Have no contraindications to MR evaluations: e.g. pacemaker or magnetically active\r\n             metal fragments, claustrophobia\r\n\r\n          -  Ability to comply with protocol\r\n\r\n          -  Competent and able to provide written informed consent\r\n\r\n          -  Must have failed standard medical therapy including anti-TNF agents\r\n\r\n        Exclusion Criteria\r\n\r\n          -  Inability to give informed consent.\r\n\r\n          -  Clinically significant medical conditions within the six months before administration\r\n             of MSCs: e.g. myocardial infarction, active angina, congestive heart failure or other\r\n             conditions that would, in the opinion of the investigators, compromise the safety of\r\n             the patient.\r\n\r\n          -  Specific exclusions: Evidence of hepatitis B, C, or HIV\r\n\r\n          -  History of cancer including melanoma (with the exception of localized skin cancers)\r\n\r\n          -  Investigational drug within thirty (30) days of baseline\r\n\r\n          -  A resident outside the United States\r\n\r\n          -  Pregnant or breast feeding.\r\n\r\n          -  History of clinically significant auto-immunity (other than Crohn's disease) or any\r\n             previous example of fat-directed autoimmunity\r\n\r\n          -  Previous allergic reaction to a perianal fistula plug.\r\n\r\n          -  If liposuction is not technically feasible\r\n\r\n          -  Allergic to local anesthetics\r\n\r\n          -  Pregnant patients or trying to become pregnant.\r\n\r\n          -  Non-enterocutaneous tracts (ie recto-vaginal, entero-vesicular)\r\n      ","sponsor":"William A. Faubion, M.D.","sponsor_type":"Other","conditions":"Perianal Crohn's Disease","interventions":[{"intervention_type":"Drug","name":"Drug: MSC-AFP"}],"outcomes":[{"outcome_type":"primary","measure":"To determine the safety and toxicity of using autologous MSC coated fistula plug in patients with fistulizing Crohn's Disease.","time_frame":"2-24 months","description":"The primary endpoint of this study is to determine the safety and feasibility of using adipose derived, autologous mesenchymal stromal cells (MSC) bound to the Gore® Bio-A® Fistula Plug for treatment of refractory CD perianal fistulae."},{"outcome_type":"secondary","measure":"To assess in preliminary fashion the response of fistula healing induced by the GORE plug containing MSC","time_frame":"2-24 months","description":"To assess in preliminary fashion the response of fistula healing induced by the GORE plug containing MSC i) Clinically by drainage assessment and ii) Radiographically by MRI, the gold standard test for assessment of healing."}]}
{"nct_id":"NCT01789840","start_date":"2013-07-31","phase":"N/A","enrollment":59,"brief_title":"Prostate Artery Embolization With Embosphere Microspheres Compared to TURP for Benign Prostatic Hyperplasia","official_title":"Prospective, Controlled Investigation of Prostate Artery Embolization With Embosphere Microspheres Compared to Transurethral Resection of the Prostate for the Treatment of Symptomatic Benign Prostatic Hyperplasia","primary_completion_date":"2017-06-30","study_type":"Interventional","rec_status":"Terminated","completion_date":"2017-12-31","last_update":"2020-09-02","description":"The purpose of this study is to evaluate improvement of symptoms from benign prostatic hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) for prostatic artery embolization (PAE) using Embosphere Microspheres compared to conventional transurethral resection of the prostate (TURP).","other_id":"BPH-P3-12-01","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":50,"maximum_age":79,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patient is age 50 to 79, inclusive\r\n\r\n          2. Patient has signed informed consent\r\n\r\n          3. Patient has had lower urinary tract symptoms (LUTS) secondary to BPH for at least 6\r\n             months prior to study treatment\r\n\r\n          4. Patient has a baseline IPSS Score > 13 at baseline\r\n\r\n          5. Patient has a prostate size of at least 50 grams and not more than 90 grams, measured\r\n             by MRI\r\n\r\n          6. Patient has BPH symptoms refractory to medical treatment or for whom medication is\r\n             contraindicated, not tolerated or refused\r\n\r\n          7. Patient must be a candidate for TURP\r\n\r\n          8. Patient must meet ONE of the following criteria:\r\n\r\n               -  Baseline Prostate Specific Antigen (PSA) <2.5 ng/mL (no prostate biopsy required)\r\n\r\n               -  Baseline PSA >2.5 ng/mL and 10 ng/mL AND free PSA > 25% of total PSA (no\r\n                  prostate biopsy required)\r\n\r\n               -  Baseline PSA >2.5 ng/mL and 10 ng/mL AND free PSA < 25% of total PSA AND a\r\n                  negative prostate biopsy result (minimum 12 core biopsy)\r\n\r\n               -  Baseline PSA >10 ng/mL AND a negative prostate biopsy (minimum 12 core biopsy)\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Active urinary tract infection\r\n\r\n          2. Biopsy proven prostate or bladder cancer, or any cancer other than basal or squamous\r\n             cell skin cancer\r\n\r\n               -  The following patients must undergo prostate biopsy with a minimum of 12 cores\r\n                  and have a negative histopathology report to be enrolled in the study:\r\n\r\n                    -  Patients with digital rectal examination (DRE) findings suspicious for\r\n                       prostate cancer\r\n\r\n                    -  Patients with baseline PSA levels > 10 ng/mL\r\n\r\n                    -  Patients with baseline PSA levels >2.5 ng/mL and < 10ng/mL AND free PSA <\r\n                       25% of total PSA\r\n\r\n               -  Patients with cystoscopy findings suspicious for bladder cancer must undergo\r\n                  biopsy and have a negative histopathology report to be enrolled in the study\r\n\r\n          3. Bladder atonia, neurogenic bladder disorder or other neurological disorder that is\r\n             impacting bladder function (eg multiple sclerosis, Parkinson's disease, spinal cord\r\n             injuries, etc)\r\n\r\n          4. Urethral stricture, bladder neck contracture, sphincter abnormalities, urinary\r\n             obstruction due to causes other than BPH, or other potentially confounding bladder or\r\n             urethral disease or condition\r\n\r\n          5. Patient has taken beta blockers, antihistamines, anticonvulsants, or antispasmodics\r\n             within 1 week of study treatment AND has not been on the same drug dosage for 6 months\r\n             with a stable voiding pattern\r\n\r\n              Dosage of these medications should not change during study participation unless\r\n             medically necessary\r\n\r\n          6. Patient has taken antidepressants, anticholinergics, androgens or\r\n             gonadotropin-releasing hormonal analogues within 2 months of study treatment AND has\r\n             not been on the same drug dosage for at least 3 months with a stable voiding pattern\r\n\r\n          7. Patient has taken 5-alpha reductase inhibitors or alpha blockers within 1 month of\r\n             study treatment AND has not been on the same drug dosage for at least 3 months with a\r\n             stable voiding pattern\r\n\r\n          8. Previous non-medical BPH treatment, including surgery, TURP, needle ablation,\r\n             microwave or laser therapy, balloon dilation, stent implantation, or any other\r\n             invasive treatment to the prostate\r\n\r\n          9. Any known condition that limits catheter-based intervention or is a contraindication\r\n             to embolization, such as intolerance to a vessel occlusion procedure or severe\r\n             atherosclerosis.\r\n\r\n         10. Patient is unable to stop taking anticoagulant, nonsteroidal antiinflammatory drug\r\n             (NSAID) or anti-platelet therapy for 7 days prior to study treatment\r\n\r\n         11. Unable to have MRI imaging (eg metal implant including pacemaker, replacement joint,\r\n             etc)\r\n\r\n         12. Patient has an asymmetric prostate, with > 20% difference in size between lobes\r\n\r\n         13. Cardiac condition including congestive heart failure or arrhythmia, uncontrolled\r\n             diabetes mellitus, significant respiratory disease or known immunosuppression which\r\n             required hospitalization within the previous 6 months\r\n\r\n         14. Baseline serum creatinine level > 1.8 mg/dl\r\n\r\n         15. Known upper tract renal disease\r\n\r\n         16. Cystolithiasis or chronic hematuria within 3 months prior to study treatment\r\n\r\n         17. Active prostatitis\r\n\r\n         18. Previous rectal surgery other than hemorrhoidectomy, or history of rectal disease\r\n\r\n         19. History of pelvic irradiation or radical pelvic surgery\r\n\r\n         20. Patient is interested in future fertility\r\n\r\n         21. Coagulation disturbances not normalized by medical treatment\r\n\r\n         22. Acute urinary retention requiring an indwelling catheter\r\n\r\n         23. Known major iliac arterial occlusive disease\r\n\r\n         24. Allergy to iodinated contrast agents\r\n\r\n         25. Hypersensitivity to gelatin products\r\n      ","sponsor":"Merit Medical Systems, Inc.","sponsor_type":"Industry","conditions":"Benign Prostatic Hyperplasia","interventions":[{"intervention_type":"Device","name":"Device: Embosphere Microspheres"},{"intervention_type":"Procedure","name":"Procedure: TURP"}],"outcomes":[{"outcome_type":"other","measure":"Change from baseline in mean prostate volume, as determine by MRI","time_frame":"12 months","description":"The mean prostate volume as assessed by MRI will be summarized for both treatment groups for the baseline, 3 month and 12 month timepoints, including change from baseline. The difference in treatment means will be calculated for each timepoint, including the corresponding 95% confidence interval for the ITT and Evaluable populations."},{"outcome_type":"primary","measure":"IPSS Score","time_frame":"12 months","description":"The primary endpoint will be improvement of symptoms from BPH evaluated using the IPSS at 12 months post procedure."},{"outcome_type":"secondary","measure":"Duration of hospitalization post procedure","time_frame":"1 month","description":"The duration of hospitalization associated with the procedure will be calculated in hours.The difference in treatment means will be calculated, including the corresponding 95% confidence interval, and treatment groups will be compared using Student's t-test for the ITT and Evaluable populations. If the distribution of the data is found to differ substantially from normal, appropriate methods will be used to analyze the data, including a data transformation or time to event analysis."},{"outcome_type":"secondary","measure":"Duration of post procedure catheterization","time_frame":"1 month","description":"The duration of post procedure catheterization will be calculated in hours. The difference in treatment means will be calculated, including the corresponding 95% confidence interval and treatment groups will be compared using Student's t-test for the ITT and Evaluable populations. If the distribution of the data is found to differ substantially from normal, appropriate methods will be used to analyze the data, including a data transformation or time to event analysis."},{"outcome_type":"secondary","measure":"Overall adverse events","time_frame":"12 months","description":"Safety summaries will include the incidence of treatment-emergent adverse events (TEAEs). Treatment-emergent adverse events (TEAEs) are defined as any event that began on or after the date of treatment or worsened in severity or frequency after treatment was initiated. Events worsening in severity should be considered new adverse events. Adverse events recorded on the CRF which began prior to treatment will not be included in the summary tables but will be included in the AE data listings."},{"outcome_type":"secondary","measure":"Procedure related adverse events","time_frame":"12 months","description":"Safety summaries will include the incidence of treatment-emergent adverse events (TEAEs). Treatment-emergent adverse events (TEAEs) are defined as any event that began on or after the date of treatment or worsened in severity or frequency after treatment was initiated. Events worsening in severity should be considered new adverse events. Adverse events recorded on the CRF which began prior to treatment will not be included in the summary tables but will be included in the AE data listings."},{"outcome_type":"other","measure":"Change from baseline in peak urine flow rate (Qmax)","time_frame":"12 months","description":"The peak urine flow rate (Qmax) from the urodynamic and uroflowmetry assessments will be summarized for both treatment groups for the baseline and 12 month timepoints, including change from baseline. The difference in treatment means will be calculated for each timepoint, including the corresponding 95% confidence interval for the ITT and Evaluable populations."},{"outcome_type":"other","measure":"Change from baseline in erectile function using the International Index of Erectile Function (IIEF)","time_frame":"12 months","description":"Each subscale will be summarized separately for both treatment groups for the baseline, 1 month, 3 month, 6 month, and 12 month timepoints, including change from baseline. The difference in treatment means will be calculated for each timepoint, including the corresponding 95% confidence interval for the ITT and Evaluable populations.\r\nErectile Function (items 1, 2, 3, 4, 5, 15)\r\nOrgasmic Function (items 9, 10)\r\nSexual Desire (items 11, 12)\r\nIntercourse Satisfaction (items 6, 7, 8)\r\nOverall Satisfaction (items 13, 14)"},{"outcome_type":"other","measure":"Change from baseline in post-void residual urinary volume (PVR)","time_frame":"12 months","description":"The post void residual volume (PVR) from the urodynamic and uroflowmetry assessments will be summarized for both treatment groups for the baseline and 12 month timepoints, including change from baseline. The difference in treatment means will be calculated for each timepoint, including the corresponding 95% confidence interval for the ITT and Evaluable populations."},{"outcome_type":"other","measure":"Change in baseline from prostate specific antigen (PSA)","time_frame":"12 months","description":"Prostate specific antigen (PSA) will be summarized for both treatment groups for the baseline, 1 month, 3 month, 6 month, and 12 month timepoints, including change from baseline. The difference in treatment means will be calculated for each timepoint, including the corresponding 95% confidence interval for the ITT and Evaluable populations."}]}
{"nct_id":"NCT02038023","start_date":"2013-07-31","phase":"Phase 2","enrollment":74,"brief_title":"Intravaneous Iron(1000 mg Low Molecular Weight Iron Dextran Over 60 Minutes) for Pregnant Women","official_title":"Intravaneous Iron(1000 mg Low Molecular Weight Iron Dextran Over 60 Minutes) for Moderate to Severe Iron Deficient Anemia of Pregnancy in Women Intolerant of or Responsive to Oral Iron.","primary_completion_date":"2015-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-08-31","last_update":"2018-06-28","description":"To determine the percentage of women who achieve anemia correction after a single dose of 1000mg of low molecular weight iron dextran(infed).","other_id":"Intravaneous Iron in Pregnancy","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  pregnant women intolerable to oral iron. hbg <10.9 g/dl during second or third\r\n             trimester.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  known sensitivity to IV iron. hemoglobinopathies. hemolytic anemia. women who have\r\n             received or will receive blood transfusions. women with significant vaginal\r\n             bleeding(>200 cc blood loss)prior to delivery. women with documented history of\r\n             allergy to more than one class of drug clinically significant anemia requiring therapy\r\n             in the opinion of the obstetrician, in the first trimester.\r\n      ","sponsor":"Auerbach Hematology Oncology Associates P C","sponsor_type":"Other","conditions":"Pregnancy","interventions":[{"intervention_type":"Drug","name":"Drug: Intravaneous iron(low molecular weight iron dextran)","description":"1000 mg of Iron dextran administered over one hour"}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of Women Who Achieve Anemia Correction After a Single Dose of 1000mg of Low Molecular Weight Iron Dextran(INfeD).","time_frame":"4 weeks after infusion or post-partum"},{"outcome_type":"secondary","measure":"Serum Ferritin","time_frame":"4 weeks post infusion or post-partum"},{"outcome_type":"secondary","measure":"Percent Transferrin Saturation","time_frame":"4 weeks post infusion or post-partum"},{"outcome_type":"secondary","measure":"Safety as Measured by Number of Adverse Events","time_frame":"4 weeks after infusion and 4 weeks post-partum","description":"To evaluate the safety of IV low molecular weight iron dextran in pregnant women. Also to asses maternal and fetal outcomes-preterm delivery, low-birth weight deliveries, ER visits and hospitalizations related to preterm labor, preterm contractions, ante-partum and post partum transfusions, maternal hemoglobin at post-partum visit after IV iron supplementation groups. A questionaire with a list of symptoms to include nausea, dizziness, hypotension, edema, headache, abdominal pain, chest pain, cough, itching, fever, back pain, muscle cramps and rash are asked immediately after administration and phone calls at 24, 48 hours and 7 days."}]}
{"nct_id":"NCT01884935","start_date":"2013-07-31","phase":"Phase 1","enrollment":13,"brief_title":"PK and PD Study of Natalizumab in Pediatric Subjects With RRMS","official_title":"A Phase 1, Multicenter, Open-Label, Single-Arm, Multiple Dose Study to Evaluate the the Pharmacokinetics and Pharmacodynamics of Natalizumab in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RMS)","primary_completion_date":"2014-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-09-30","last_update":"2016-06-23","description":"The primary objective of the study is to determine the pharmacokinetic (PK) profile of multiple doses of natalizumab in pediatric subjects with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives are as follows: to characterize the pharmacodynamic (PD) profile of natalizumab (as defined by 4 integrin binding) and to explore the safety and tolerability of multiple doses of natalizumab in the pediatric population.","other_id":"101MS328","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":10,"maximum_age":17,"population":"","criteria":"\n        Key Inclusion Criteria:\r\n\r\n        - Rapidly evolving severe relapsing remitting multiple sclerosis, defined by 2 or more\r\n        disabling relapses in 1 year, and with 1 or more gadolinium-enhancing lesions on brain MRI\r\n        or a significant increase in T2 lesion load, as compared to a previous recent magnetic\r\n        resonance imaging (MRI)\r\n\r\n        Key Exclusion Criteria:\r\n\r\n          -  History of, or abnormal laboratory values indicative of, significant medical,\r\n             neurologic (other than MS), or psychiatric disorders that might preclude participation\r\n             in the study in the opinion of the Investigator.\r\n\r\n          -  Prior natalizumab therapy.\r\n\r\n        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply\r\n      ","sponsor":"Biogen","sponsor_type":"Industry","conditions":"Relapsing-Remitting Multiple Sclerosis","interventions":[{"intervention_type":"Biological","name":"Biological: Natalizumab","description":"As specified in the treatment arm"}],"outcomes":[{"outcome_type":"primary","measure":"predose (trough) concentrations from multiple dosing (Cpredose)","time_frame":"Up to week 16"},{"outcome_type":"primary","measure":"maximum plasma concentration (Cmax)","time_frame":"Up to Week 16"},{"outcome_type":"primary","measure":"time to maximum plasma concentration (Tmax)","time_frame":"Up to Week 16"},{"outcome_type":"primary","measure":"area under the plasma concentration curve from time of first dose to infinity (AUCinf)","time_frame":"Up to Week 16"},{"outcome_type":"primary","measure":"apparent clearance (Cl/F)","time_frame":"Up to Week 16"},{"outcome_type":"primary","measure":"volume of distribution","time_frame":"Up to Week 16"},{"outcome_type":"primary","measure":"elimination half-life (t1/2)","time_frame":"Up to Week 16"},{"outcome_type":"secondary","measure":"the average and minimum saturation values of α4 integrin over the dosing interval","time_frame":"Up to Week 16"},{"outcome_type":"secondary","measure":"incidence of serious adverse events (SAEs), infusion and hypersensitivity reactions, and other AEs","time_frame":"Up to Week 16"},{"outcome_type":"secondary","measure":"the presence of anti-natalizumab antibodies","time_frame":"Up to Week 16"}]}
{"nct_id":"NCT03177447","start_date":"2013-07-01","phase":"N/A","enrollment":62,"brief_title":"ENABLE: CHF-PC (Comprehensive Heartcare For Patients and Caregivers)","official_title":"ENABLE: CHF-PC (Educate, Nurture, Advise, Before Life Ends: Comprehensive Heartcare for Patients and Caregivers)","primary_completion_date":"2015-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-12-31","last_update":"2020-05-27","description":"Background: Early palliative care (EPC) is recommended but rarely integrated with advanced heart failure (HF) care. This pilot study engaged patients and family caregivers to study the feasibility and site differences in a two-site EPC trial, ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers). An EPC feasibility study (4/1/14-8/31/15) was conducted for patients with New York Heart Association (NYHA) Functional Class III/IV HF and their caregivers in academic medical centers in the northeast and southeast U.S. The EPC intervention comprised: 1) an in-person palliative care consultation; and 2) telephonic nurse coach sessions and monthly calls. Patient- and caregiver-reported outcomes were collected for quality of life (QOL), symptom, health, anxiety, and depression outcomes at baseline, 12- and 24-weeks. Linear mixed-models were used to assess baseline to week 24 longitudinal changes. The intervention was tailored to rural, older adults (age65) with advanced HF in reducing HF morbidity and improving patient and caregiver QOL and quality of care.","other_id":"X130827010","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":50,"population":"","criteria":"\n        Patient Inclusion Criteria:\r\n\r\n          1. English-speaking and able to complete baseline interview\r\n\r\n          2. Age 65 (Age criteria was reduced to 50 y/o given regional experience with HF\r\n             population)\r\n\r\n          3. NYHA Stage III/IV heart failure; American College of Cardiology (ACC) Class C/D\r\n\r\n          4. Have a land-based phone or reliable cellular phone service\r\n\r\n          5. Have an agreeable partner willing to participate in the study* (recommended) *In our\r\n             previous studies we have not required patients to have a care partner for eligibility.\r\n             In this study it is essential that we have an adequate number of caregivers to test\r\n             the caregiver intervention. Therefore patients without a care partner will still be\r\n             considered but the final study sample size may need to be adjusted to ensure an\r\n             adequate caregiver sample.\r\n\r\n        Patient Exclusion Criteria:\r\n\r\n          1. Non-correctable hearing loss\r\n\r\n          2. Dementia or significant confusion (as measured by a Callahan score of 3\r\n\r\n          3. Diagnostic and Statistical Manual (DSM) -IV Axis I diagnosis (e.g. schizophrenia,\r\n             bipolar disorder) or active substance use disorder\r\n\r\n        Caregiver Inclusion Criteria:\r\n\r\n          1. \"Caregiver\" is identified by the patient as \"a person who knows you well and is\r\n             involved in your medical care\". May be a spouse or adult family member or friend\r\n             living in the same household or considered by the patient to be the primary caregiver\r\n             and be willing to participate.\"\r\n\r\n          2. English-speaking and able to complete baseline interview 3. Have a land-based phone or\r\n             reliable cellular phone service.\r\n\r\n        Caregiver Exclusion Criteria:\r\n\r\n        1. Non-correctable hearing loss.\r\n      ","sponsor":"University of Alabama at Birmingham","sponsor_type":"Other","conditions":"Heart Failure, Congestive","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: ENABLE CHF-PC","description":"An Advanced Practice Palliative Care Nurse Coach implements Charting Your Course (CYC), a phone-based, 6-session patient curriculum and a 3-session caregiver curriculum, followed by monthly phone supportive care follow-up. Sessions 1-3 incorporate Hegel's problem-solving approach that was modified to counsel seriously ill patients using MacMillan's COPE model reactivity, which includes 4 components: Creativity, Optimism, Planning and Expert information. These sessions address adjusting to chronic illness, symptom management, communication, and decision-making. Patient sessions 4-6 comprise OUTLOOK, a life review intervention to improve QOL in serious illness developed at Duke."}],"outcomes":[{"outcome_type":"primary","measure":"Feasibility of recruitment for a large-scale RCT.","time_frame":"From Date of Enrollment to 24 Weeks","description":"Number (#) of participants enrolled within 2 years compared to study's target goal."},{"outcome_type":"primary","measure":"Feasibility of retention for a large-scale RCT.","time_frame":"From Date of Enrollment to 24 Weeks","description":"Number (#) of participants completing study activities by 24 weeks."},{"outcome_type":"primary","measure":"Feasibility of intervention completion for a large-scale RCT.","time_frame":"From Date of Enrollment to 24 Weeks","description":"Number (#) of participants completing all intervention sessions by 24 weeks."},{"outcome_type":"primary","measure":"Feasibility of measurement completion for a large-scale RCT.","time_frame":"From Date of Enrollment to 24 Weeks","description":"Number (#) of participants completing outcomes measures by 24 weeks."},{"outcome_type":"secondary","measure":"Patient Quality of Life","time_frame":"Baseline, week 12, and week 24.","description":"Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered HF-specific questionnaire that describes physical limitations (1 item), symptoms (frequency-4 items,severity-3 items, change over time-1 item) self-efficacy/ knowledge (2 items), social interference (1 item) and QOL (3 items). Individual domains show high internal consistency reliability (Cronbach's alpha's .62-.90). It is reported to take 6 minutes to complete. Two summary scores (functional and clinical) can be calculated. It is reported to be more sensitive to clinical change than other HF-specific measures. Scores range from 0-100 wherein higher scores indicate better health status."},{"outcome_type":"secondary","measure":"Patient Quality of Care","time_frame":"Baseline, week 12, and week 24.","description":"Patient Assessment of Chronic Illness Care (PACIC) is a 20-item patient reported measure of chronic illness care (CIC) health counseling behaviors. It consists of the five CIC constructs: patient activation, delivery system/ decision support, goal setting, problem-solving, and follow-up/ coordination. It has good internal consistency with Cronbach alphas ranging from .78 to .90, and test-retest reliability, estimated by intracluster correlation coefficient (ICC), was at least 0.77."}]}
{"nct_id":"NCT01847378","start_date":"2013-06-30","enrollment":10,"brief_title":"Feasibility of Contact Force Catheter Mapping and Ablation in Epicardial and Endocardial Ventricular Tachycardias","official_title":"EPIcardial and Endocardial Mapping and Ablation Using Contact Force Catheter in Chagasic Patients With Sustained Ventricular Tachycardia","primary_completion_date":"2015-05-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2015-08-31","last_update":"2014-10-21","description":"Ventricular tachycardia is one of the commonest cause of sudden death in chronic chagas disease. As most ventricular tachycardias originate from scar in patients with heart disease, catheter ablation is an important step in patient treatment. Identification of fibrosis prior to ablation of sustained ventricular tachycardia (SVT) might reduce the time of anesthesia, procedure time, radiation exposure and possibly the risk of complications. Knowledge of arrhythmia circuit within scar allows planning strategies for each procedure. Condreanu et al. stablished that voltages inferior to 6.52 mV (unipolar) and 1.54mV (bipolar) are useful tools in detecting scar during electroanatomic mapping. Accuracy, however when compared to magnetic resonance imaging is limited due to difficulties in maintaining good contact between ablation catheter and ventricular wall. Contact force catheters might help increase accuracy of voltage mapping because they allow detection of poor contact areas. Although the threshold for identification of scar in ischemic and non ischemic patients during electroanatomical mapping is already known, this parameters still lacking for chronic chagasic individuals. A marked qualitative histological difference between these fibrous scars supports the hypothesis that voltage scar in chagasics might be different. Catheter ablation contact with endo and epicardial surface is an important issue when ablating arrhythmias. Conventional catheter ablation is not equipped with sensors capable of detecting degree of contact with the target. To our knowledge, the literature lacks information in regard to late lesions produced by a known contact force pressure \"in vivo\". The pattern of electrical activation in these patients and their relationship with local coronary veins for resynchronization likely to approach through the coronary sinus can be useful in defining chagasic that can benefit from resynchronization. 1. Compare endocardial and epicardial impedance and voltage using CARTO 3 with fibrosis on 3T MRI 2. Correlate areas of late activation within scar during activating mapping in sinus rhythm with different signal intensity in 3T MRI 3. Evaluate the influence of contact pressure during application of radiofrequency in making fibrosis analyzed 30 days after the procedure using a 3T MRI. 4. Assess the site of latest left ventricular activation in sinus rhythm and correlate with the coronary veins location","other_id":"ISII","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":80,"population":"Chagasic patients with symptomatic documented ventricular tachycardia","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  individuals aged between 18 and 80 years old\r\n\r\n          -  life expectancy greater than 1 year\r\n\r\n          -  positive reaction in at least two different serologic techniques for Chagas disease\r\n             (ELISA, indirect hemagglutination or indirect immunofluorescence)\r\n\r\n          -  symptomatic recurrent monomorphic ventricular tachycardia (recorded by holter,\r\n             electrocardiogram or looper)\r\n\r\n          -  prior to implantable cardioverter defibrillator implantation in patients with\r\n             ventricular tachycardia as an attempt to prevent shoks\r\n\r\n          -  patients in \"electrical storm\", defined as three or more episodes of ventricular\r\n             tachycardia in 24h. Each episode must demand a medical intervention.\r\n\r\n          -  monomorphic ventricular tachycardia induced during electrical physiological study in\r\n             patients with syncope of unexplained cause\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  claustrophobia\r\n\r\n          -  creatinine clearance inferior to 30ml/min/m2 (clearance between 30ml/min/m2 and\r\n             60ml/min/m2 will be analyzed individually)\r\n\r\n          -  thrombus in the left ventricle\r\n\r\n          -  pregnancy\r\n\r\n          -  heart failure NYHA IV\r\n\r\n          -  allergy to iodinated contrast or gadolinium\r\n\r\n          -  patients with implantable devices (pacemakers, implantable defibrillators and similar)\r\n\r\n          -  coagulopathy (INR > 1,5 or aPTT 2x normal values)\r\n\r\n          -  platelet count inferior to 100.000\r\n      ","sponsor":"Federal University of So Paulo","sponsor_type":"Other","conditions":"Ventricular Tachycardia|Sudden Death|Syncope|Chest Pain","interventions":[{"intervention_type":"Procedure","name":"Procedure: Catheter ablation","description":"During mapping and ablation tissue voltage and impedance will be stored and analyzed thereafter. The same procedure will be done in regard to activating maps."}],"outcomes":[{"outcome_type":"primary","measure":"Evaluate the feasibility of mapping and ablating ventricular tachycardias in endocardial and epicardial using a contact force catheter","time_frame":"Immediatly after the procedure","description":"The feasibility will be evaluated immediatly after the procedure"},{"outcome_type":"secondary","measure":"Evaluate the impedance and voltage threshold for scar in chronic chagasic cardiomyopathy","time_frame":"After the procedure"}]}
{"nct_id":"NCT01861535","start_date":"2013-06-30","phase":"Phase 3","enrollment":110,"brief_title":"Primary Imiquimod Treatment Versus Surgery for Vulvar Intraepithelial Neoplasia","official_title":"Primary Imiquimod Treatment Versus Surgery for Vulvar Intraepithelial Neoplasia","primary_completion_date":"2021-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2021-02-28","last_update":"2021-04-14","description":"To evaluate the efficacy (defined as complete clinical response at 6 months) of imiquimod vs. standard treatment (surgery) for vulvar intraepithelial neoplasia (VIN).","other_id":"KLI293","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":90,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically confirmed VIN (only usual type, formerly VIN 2-3)\r\n\r\n          -  Visible, measurable lesion(s)\r\n\r\n          -  Contraception (for premenopausal women)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Evidence of invasion\r\n\r\n          -  History of cancer or severe inflammatory dermatosis of the vulva\r\n\r\n          -  Pregnancy, lactation\r\n\r\n          -  Immunodeficiency\r\n\r\n          -  Any treatment for VIN within the previous three months\r\n\r\n          -  Known hypersensitivity to imiquimod\r\n      ","sponsor":"Medical University of Graz","sponsor_type":"Other","conditions":"Vulvar Intraepithelial Neoplasia","interventions":[{"intervention_type":"Drug","name":"Drug: Imiquimod"},{"intervention_type":"Procedure","name":"Procedure: Surgery"}],"outcomes":[{"outcome_type":"other","measure":"Aesthetic results","time_frame":"12 months","description":"Detailed photos of the overall vulva will be taken. Photos will be compared to photos at baseline and judged by 4 independent, blinded observers for aesthetic results."},{"outcome_type":"primary","measure":"Complete clinical response","time_frame":"6 months","description":"No clinical evidence of vulvar lesion, i.e. 100% reduction of primary lesion size"},{"outcome_type":"secondary","measure":"Clinical response/ lesion size","time_frame":"6 months","description":"Vulvar lesions will be described, measured with calipers, mapped and photographed. The digital photos will be analyzed with a computer program (ImageJ) to calculate the total lesion size in cm². Results will be classified as: no response (NR, reduction in lesion size of 25% or less), weak partial response (wPR, 26-75% reduction), strong partial response (stPR, 76%-99% reduction) and Complete response (CR, 100% reduction)."},{"outcome_type":"secondary","measure":"Histologic response","time_frame":"6 months","description":"At baseline punch biopsies will be taken from the affected areas. The site of the initial biopsy will be photodocumented to ensure that the follow-up biopsy at 6 months is taken from the same site. Histologic results will be classified as response (R): complete disappearance of usual type VIN or reduction to VIN1,or no response (NR). All biopsy samples will be analysed independently by two experienced gynecologic pathologists unaware of the treatment allocation"},{"outcome_type":"secondary","measure":"Extent of surgery","time_frame":"6 months","description":"The number, types and extent of surgical procedures will be recorded. The extent of surgery will be recorded as total operated lesion size (in cm², as measured on pre-operative photograph) and relative operated lesion size (percentage of operated lesion size compared with the original pretreatment lesion size)"},{"outcome_type":"secondary","measure":"HPV status","time_frame":"6 months","description":"HPV status will be measured with the qualitative cobas® HPV Test, Roche, and the the APTIMA ® HPV assay, Gen-Probe."},{"outcome_type":"secondary","measure":"Clinical response/lesion size","time_frame":"12 months","description":"Vulvar lesions will be described, measured with calipers, mapped and photographed. The digital photos will be analyzed with a computer program (ImageJ) to calculate the total lesion size in cm². Results will be classified as: no response (NR, reduction in lesion size of 25% or less), weak partial response (wPR, 26-75% reduction), strong partial response (stPR, 76%-99% reduction) and Complete response (CR, 100% reduction)."},{"outcome_type":"secondary","measure":"Extent of surgery","time_frame":"12 months","description":"The number, types and extent of surgical procedures will be recorded. The extent of surgery will be recorded as total operated lesion size (in cm², as measured on pre-operative photograph) and relative operated lesion size (percentage of operated lesion size compared with the original pretreatment lesion size)"},{"outcome_type":"secondary","measure":"HPV status","time_frame":"12 months","description":"HPV status will be measured with the qualitative cobas® HPV Test, Roche, and the the APTIMA ® HPV assay, Gen-Probe."},{"outcome_type":"other","measure":"\"Cervical Dysplasia Distress\" Questionnaire","time_frame":"6 months","description":"Change from baseline in \"Cervical Dysplasia Distress\" score at 6 months"},{"outcome_type":"other","measure":"\"Cervical Dysplasia Distress\" questionnaire","time_frame":"12 months","description":"Change from Baseline in \"Cervical Dysplasia Distress\" score at 12 months"},{"outcome_type":"other","measure":"\"Fear of Progression\" Questionnaire","time_frame":"6 months","description":"Change from Baseline \"Fear of Progression\" score at 6 months."},{"outcome_type":"other","measure":"\"Fear of Progression\" questionnaire","time_frame":"12 months","description":"Change from Baseline \"Fear of Progression\" score at 12 months."},{"outcome_type":"other","measure":"\"Sexual activity\" Questionnaire","time_frame":"6 months","description":"Change from baseline \"Sexual activity\" score at 6 months"},{"outcome_type":"other","measure":"\"Sexual activity\" questionnaire","time_frame":"12 months","description":"Change from baseline \"Sexual activity\" score at 12 months"},{"outcome_type":"other","measure":"Immune cells in the epidermis","time_frame":"6 months","description":"Histochemical analysis of immune cells from vulvar biopsy samples will be performed at baseline and at 6 months. Frozen sections will be prepared and stained with corresponding cell markers. Immune cell populations will be quantified as number of cells per square millimetre and will be compared between the two treatment groups. The following markers and their primary antibodies will be analysed: CD1a, marker for Langerhans cells, CD94, marker for natural killer cells, CD4, marker for T-helper cells, CD8, marker for cytotoxic T-cells and CD207, marker for immature dendritic cells expressing Langerin."},{"outcome_type":"other","measure":"Aesthetic results","time_frame":"6 months","description":"Detailed photos of the overall vulva will be taken. Photos will be compared to photos taken at baseline and judged by 4 independent, blinded observers for aesthetic results."},{"outcome_type":"other","measure":"Visual analogue scale (VAS) for assessment of pain and pruritus","time_frame":"6 months","description":"Change of VAS score for pain and pruritus from baseline to 6 months. VAS will be assessed at baseline, 1,2 ,3,4,5 and 6 months."}]}
{"nct_id":"NCT01832857","start_date":"2013-06-30","phase":"Phase 2","enrollment":7,"brief_title":"Phase 2 Safety, Tolerability and Efficacy Study of CPI-613 in Cancer Patients","official_title":"An Open Label, Phase 2 Trial to Evaluate the Safety, Tolerability and Efficacy of CPI-613 in Cancer Patients","primary_completion_date":"2016-12-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2016-12-31","last_update":"2016-12-29","description":"This Phase II study is conducted to assess the safety and efficacy of CPI-613 in patients with advanced and/or metastatic solid tumors for whom there there is no available therapy to provide clinical benefit or for those who have refused further standard therapy. The primary outcome measure is Overall Survival (OS). The secondary outcome measures are: Response Rate (RR), Progression-Free Survival (PFS), and safety.","other_id":"CL-CPI-613-023","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients must have advanced and/or metastatic, histologically or cytologically\r\n             documented solid tumors, for whom there is no available therapy shown to provide\r\n             clinical benefit or for those who have refused further standard therapy\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status being 0-2\r\n\r\n          -  Expected survival >3 months\r\n\r\n          -  18 years of age or older of both genders\r\n\r\n          -  Women of child-bearing potential must use accepted contraceptive methods (abstinence,\r\n             intrauterine device [IUD], oral contraceptive or double barrier device) during the\r\n             study, and must have a negative serum or urine pregnancy test within 1 week prior to\r\n             treatment initiation.\r\n\r\n          -  Fertile men must practice effective contraceptive methods during the study, unless\r\n             documentation of infertility exists\r\n\r\n          -  Mentally competent, with an ability to understand and willingness to sign the informed\r\n             consent form\r\n\r\n          -  No radiotherapy, treatment with cytotoxic agents (except CPI-613), or treatment with\r\n             biologic agents within 3 weeks prior to treatment with CPI-613. At least 2 weeks must\r\n             have elapsed from any prior surgery or hormonal therapy. Patients must have fully\r\n             recovered from the acute toxicities of any prior treatment with any anti-cancer drugs,\r\n             radiotherapy or other anti-cancer modalities (returned to baseline status as noted\r\n             before most recent treatment). Patients with persisting, stable chronic toxicities\r\n             from prior treatment Grade 1 are eligible, but must be documented as such.\r\n\r\n          -  Laboratory values 2 weeks must be:\r\n\r\n          -  Adequate hematologic (white blood cell [WBC] 3500 cells/mm3 or 3.5 bil/L; platelet\r\n             count 150,000 cells/mm3 or 150 bil/L; absolute neutrophil count [ANC] 1500\r\n             cells/mm3 or 1.5 bil/L; and hemoglobin (Hgb) 9 g/dL or 90 g/L).\r\n\r\n          -  Adequate hepatic function (aspartate aminotransferase [AST/SGOT] 3x upper normal\r\n             limit [UNL], alanine aminotransferase [ALT/SGPT] 3x UNL (5x UNL if liver metastases\r\n             present), bilirubin 1.5x UNL).\r\n\r\n          -  Adequate renal function (serum creatinine 2.0 mg/dL or 177 mol/L, and blood urea\r\n             nitrogen [BUN] 25 mg/dL).\r\n\r\n          -  Adequate coagulation (\"International Normalized Ratio or INR must be 1.5\")\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Serious medical illness\r\n\r\n          -  Any active uncontrolled bleeding or patients with a bleeding diathesis\r\n\r\n          -  Patients with active central nervous system (CNS) or epidural tumor\r\n\r\n          -  Pregnant women, or women of child-bearing potential not using reliable means of\r\n             contraception\r\n\r\n          -  Lactating females\r\n\r\n          -  Fertile men unwilling to practice contraceptive methods during the study period\r\n\r\n          -  Life expectancy less than 3 months\r\n\r\n          -  Unwilling or unable to follow protocol requirements\r\n\r\n          -  Dyspnea with minimal to moderate exertion, or patients with pleural, pericardial, or\r\n             peritoneal effusions\r\n\r\n          -  Active heart disease including but not limited to symptomatic congestive heart\r\n             failure, symptomatic coronary artery disease, symptomatic angina pectoris, symptomatic\r\n             myocardial infarction, arrhythmias requiring medication, or symptomatic congestive\r\n             heart failure.\r\n\r\n          -  A marked baseline prolongation of QT/QTc interval; a history of additional risk\r\n             factors for torsade de pointes.\r\n\r\n          -  Requirement for immediate palliative treatment of any kind including surgery\r\n\r\n          -  Any condition or abnormality which may, in the opinion of the investigator, compromise\r\n             the safety of patients\r\n\r\n          -  Albumin <2.5 g/dL or <25 g/L\r\n\r\n          -  Evidence of active infection, or serious infection, with the past month\r\n\r\n          -  Patients with known HIV infection.\r\n\r\n          -  Patients receiving any other standard or investigational treatment for their cancer,\r\n             or any other investigational agent for any indication within the past 3 weeks prior to\r\n             initiation of CPI-613 treatment.\r\n\r\n          -  Patients who have received immunotherapy of any type within the past 4 weeks prior to\r\n             initiation of CPI-613 treatment\r\n\r\n          -  Patients that have received a chemotherapy regimen with stem cell support in the\r\n             previous 6 months\r\n\r\n          -  Troponin I above institution limit of normal\r\n      ","sponsor":"Rafael Pharmaceuticals Inc.","sponsor_type":"Industry","conditions":"Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: CPI-613","description":"CPI-613 drug product, provided in concentrated form at 50 mg/mL, must be diluted with D5W prior to administration. CPI-613 is to be infused intravenously (IV) via a central venous catheter. CPI-613 will be given 2x weekly, administered on Days 1 and 4 of each of the 3 treatment weeks, followed by a week of rest. The dose of CPI-613 will be 3,000 mg/m2 infused IV over 2 hours (this is the maximum tolerated dosing [MTD]), via a central venous catheter with D5W running at a rate of about 125-150 mL/hr."}],"outcomes":[{"outcome_type":"primary","measure":"Overall Survival (OS)","time_frame":"Monitored until participants pass away, for an expected average of 6 months."},{"outcome_type":"secondary","measure":"Progression-Free Survival (PFS)","time_frame":"Monitored during treatment with CPI-613 and until participants passed away, which will be an expected average of 6 months."},{"outcome_type":"secondary","measure":"Safety","time_frame":"Monitored just before study treatment, and during study treatment at the end of every 4-week treatment cycle, for an expected average of 20 weeks.","description":"Safety assessment will be based on clinical signs, vital signs, blood work, adverse events (AEs), serious adverse events (SAEs), etc."},{"outcome_type":"secondary","measure":"Response Rate","time_frame":"Monitored at the end of every 4-week treatment cycle during treatment with CPI-613, for an expected average of 20 weeks."}]}
{"nct_id":"NCT02068365","start_date":"2013-06-30","phase":"Phase 4","enrollment":41,"brief_title":"An Open-label Trial of 48-week Peginterferon Alfa-2a (PEGASYS) to Assess the Sustained Response of Chronic Hepatitis B Patients With HBeAg Seroconversion on Nucleot(s)Ide Analogue Therapy","official_title":"An Open-label Trial of 48-week Peginterferon Alfa-2a (PEGASYS) to Assess the Sustained Response of Chronic Hepatitis B Patients With HBeAg Seroconversion on Nucleot(s)Ide Analogue Therapy","primary_completion_date":"2019-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-06-30","last_update":"2019-07-31","description":"This is a multi-center, single-arm, open-label study on the virological response of chronic HBV infection to pegyinterferon-alfa-2a among patients who achieved HBeAg seroconversion on nucleos(t)ide analogue (NA) treatment. The primary endpoint of this study is to investigate the sustained response (HBeAg seroconversion with HBV DNA <2000 IU/ml) to peginterferon at 24 weeks after the end of treatment.","other_id":"ML28486","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male & female patients >= 18 and < 70 years of age\r\n\r\n          -  Positive HBeAg before starting NA treatment\r\n\r\n          -  Treated by a single NA (lamivudine, adefovir, entecavir or tenofovir) for 6 months to\r\n             5 years\r\n\r\n          -  Developed HBeAg seroconversion (HBeAg negative and ant-HBe negative) with undetectable\r\n             HBV DNA by PCR based assay on NA treatment.\r\n\r\n          -  Negative urine or serum pregnancy test (for women of childbearing potential)\r\n             documented within the 24-hour period prior to the first dose of test drug.\r\n             Additionally, all females must be using reliable contraception during the study and\r\n             for 3 months after treatment completion\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Evidence of decompensated liver disease (Childs B-C), hepato-cellular carcinoma,\r\n             pre-existing severe depression or other psychiatric disease, significant cardiac\r\n             disease, significant renal disease, seizure disorders or severe retinopathy.\r\n\r\n          -  received telbivudine as the antiviral therapy or have received more than one NA in the\r\n             past.\r\n\r\n          -  received interferon or peginterferon treatment in the past.\r\n\r\n          -  received antiviral therapy for any systemic anti-viral, anti-neoplastic or\r\n             immuno-modulatory treatment (including supraphysiologic doses of steroids and\r\n             radiation) within the past 6 months.\r\n\r\n          -  Positive test at screening for anti-HIV, anti-HCV.\r\n\r\n          -  Patients who are expected to need systemic antiviral therapy other than that provided\r\n             by the study at any time during their participation in the study are also excluded.\r\n             Exception: patients who have had a limited (<=7 days) course of acyclovir for herpetic\r\n             lesions more than 1 month prior to the first administration of test drug are not\r\n             excluded.\r\n\r\n          -  Serum total bilirubin > 3 times the upper limit of normal at screening.\r\n\r\n          -  History or other evidence of bleeding from esophageal varices or other conditions\r\n             consistent with decompensated liver disease.\r\n\r\n          -  History or other evidence of a medical condition associated with chronic liver disease\r\n             other than HBV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver diseases\r\n             including Wilson's and alpha1-antitrypsin deficiency, alcoholic liver disease, toxin\r\n             exposures, thalassemia).\r\n\r\n          -  Women with ongoing pregnancy or who are breast feeding.\r\n\r\n          -  Neutrophil count <1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening.\r\n\r\n          -  Hemoglobin < 11.5 g/dL for females and < 12.5 g/dL for men at screening.\r\n\r\n          -  Serum creatinine level >120 umol/ml for men and >105 umol/ml for women at screening.\r\n\r\n          -  History of severe psychiatric disease, especially depression. Severe psychiatric\r\n             disease is defined as major depression or psychosis, a period of treatment with an\r\n             antidepressant medication or major tranquilizer at therapeutic doses for depression or\r\n             psychosis for at least 3 months, a suicidal attempt, hospitalization for psychiatric\r\n             disease, or a period of disability due to a psychiatric disease.\r\n\r\n          -  History of immunologically mediated disease (e.g., inflammatory bowel disease,\r\n             idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia,\r\n             scleroderma, severe psoriasis, rheumatoid arthritis).\r\n\r\n          -  History or other evidence of chronic pulmonary disease associated with functional\r\n             limitation. Severe cardiac disease (e.g., NYHA Functional Class III or IV, myocardial\r\n             infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment,\r\n             unstable angina or other significant cardiovascular diseases).\r\n\r\n          -  History of a severe seizure disorder or current anticonvulsant use.\r\n\r\n          -  Evidence of an active or suspected cancer or a history of malignancy where the risk of\r\n             recurrence is >=20% within 2 years. Patients with a lesion suspicious of hepatic\r\n             malignancy on a screening imaging study will only be eligible if the likelihood of\r\n             carcinoma is <=10% following an appropriate evaluation.\r\n\r\n          -  History of having received any systemic anti-neoplastic (including radiation) or\r\n             immunomodulatory treatment (including systemic corticosteroids) <=6 months prior to\r\n             the first dose of study drug or the expectation that such treatment will be needed at\r\n             any time during the study.\r\n\r\n          -  Major organ transplantation.\r\n\r\n          -  Thyroid disease with thyroid function poorly controlled on prescribed medications.\r\n             Patients with abnormal thyroid stimulating hormone or T4 concentrations, with\r\n             elevation of antibodies to thyroid peroxidase and any clinical manifestations of\r\n             thyroid disease are excluded.\r\n\r\n          -  History or other evidence of severe retinopathy (e.g. CMV retinitis, macula\r\n             degeneration) or clinically relevant ophthalmological disorder due to diabetes\r\n             mellitus or hypertension\r\n\r\n          -  Inability or unwillingness to provide informed consent or abide by the requirements of\r\n             the study.\r\n\r\n          -  History or other evidence of severe illness or any other conditions which would make\r\n             the patient, in the opinion of the investigator, unsuitable for the study.\r\n\r\n          -  Patients with a value of alpha-fetoprotein >100 ng/mL are excluded, unless stability\r\n             (less than 10% increase) has been documented over at least the previous 3 months.\r\n\r\n          -  Evidence of drug and/or alcohol abuse (20g/day for women & 30g/day for men).\r\n\r\n          -  Patients included in another trial or having been given investigational drugs within\r\n             12 weeks prior to screening\r\n\r\n          -  Any known history of hypersensitivity to interferon.\r\n      ","sponsor":"Chinese University of Hong Kong","sponsor_type":"Other","conditions":"Chronic Hepaititis B","interventions":[{"intervention_type":"Drug","name":"Drug: Pegyinterferon-alfa-2a","description":"Pegyinterferon-alfa-2a 180mcq weekly for 48 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Sustained response (HBeAg seroconversion and HBV DNA <2000 IU/ml)","time_frame":"24 weeks post-treatment"},{"outcome_type":"secondary","measure":"HBeAg loss and seroconversion","time_frame":"24 weeks post-treatment and follow up for 5 years."},{"outcome_type":"secondary","measure":"HBsAg loss and seroconversion","time_frame":"24 weeks post-treatment and follow up for 5 years."},{"outcome_type":"secondary","measure":"HBV DNA <2000IU/ml and undetectable","time_frame":"24 weeks post-treatment and follow up for 5 years."},{"outcome_type":"secondary","measure":"ALT normalization","time_frame":"24 weeks post-treatment and long-term follow-up"},{"outcome_type":"secondary","measure":"Sustained response","time_frame":"5 years post treatment"}]}
{"nct_id":"NCT01951482","start_date":"2013-06-30","phase":"Phase 2","enrollment":108,"brief_title":"Pemetrexed/Cisplatin With or Without Bevacizumab in Brain Metastases From Non Squamous Non-small Cell Lung Cancer","official_title":"Multicenter Phase II Study of Pemetrexed/Cisplatin With or Without Bevacizumab in Patients With Brain Metastases From Non Squamous Non-small Cell Lung Cancer Harboring EGFR Wild Type","primary_completion_date":"2019-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2020-06-30","last_update":"2017-10-26","description":"This is a multi-center phase II randomized controlled study to assess the efficacy of Pemetrexed/cisplatin with or without Bevacizumab on patients with brain metastasis from non-small cell lung cancer(NSCLC) harboring EGFR wild type by intracranial PFS(iPFS),also PFS ,DCR and OS.The side effect is evaluated as well.","other_id":"NSCLC brain metastasis 02","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patient who was confirmed stage IV non squamous NSCLC with EGFR wild type and brain\r\n             metastases by pathologic histology or cytology\r\n\r\n          2. Patients who had never received therapy (including chemotherapy,WBRT,and Bevacizumab)\r\n             after diagnosed brain metastases\r\n\r\n          3. Appraisable disease, the presence of at least three lesions if longest diameter <10 mm\r\n             by brain MRI\r\n\r\n          4. Adult patients ( 18 years and 75 years). ECOG Performance Status 0 or 1 Life\r\n             expectancy of at least 12 weeks.,Haemoglobin  10.0 g/dl, Absolute neutrophil count\r\n             (ANC) 1.5 x 109/L, platelets  100 x 109/L. Total bilirubin  1.5 x upper limit of\r\n             normal (ULN). ALT and AST < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN\r\n             in case of liver metastases. Creatinine clearance  60ml/min (calculated according to\r\n             Cockcroft-gault formula).\r\n\r\n          5. Patients should be contraceptive during the period of the trial\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with a\r\n             predominant squamous component.\r\n\r\n          2. History of haemoptysis\r\n\r\n          3. Evidence of tumour invading major blood vessels on imaging.\r\n\r\n          4. Patient was received irradiation of brain. Patient with meningeal metastases were\r\n             confirmed by MRI or cytology test of cerebrospinal fluid.\r\n\r\n          5. Previous radiotherapy.\r\n\r\n          6. Serious uncontrolled coagulation disorder or thrombi-embolic complications within 6\r\n             months prior to study start or history of serious bleeding complications.\r\n\r\n          7. Major surgical procedures within 4 weeks prior to study entry.\r\n\r\n          8. Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to\r\n             the first bevacizumab infusion.\r\n\r\n          9. Non-healing wound, active peptic ulcer or bone fracture.\r\n\r\n         10. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess\r\n             within 6 months of enrollment\r\n      ","sponsor":"Sun Yat-sen University","sponsor_type":"Other","conditions":"Non Squamous Non-small Cell Lung Cancer|Brain Metastases|Bevacizumab","interventions":[{"intervention_type":"Drug","name":"Drug: Pemetrexed/cisplatin","description":"receive Pemetrexed/cisplatin every 21 days"},{"intervention_type":"Drug","name":"Drug: Bevacizumab and Pemetrexed/cisplatin","description":"receive Bevacizumab 7.5mg/kg and Pemetrexed/cisplatin every 21 days"}],"outcomes":[{"outcome_type":"primary","measure":"Compare iPFS(intracranial progression free survival) in two arms","time_frame":"3 Years"},{"outcome_type":"secondary","measure":"Response rate(CR&PR)","time_frame":"3 years"},{"outcome_type":"other","measure":"PFS: progress free survival","time_frame":"3 years"},{"outcome_type":"other","measure":"OS: overall survival","time_frame":"3 years"}]}
{"nct_id":"NCT01781572","start_date":"2013-06-30","phase":"Phase 1/Phase 2","enrollment":102,"brief_title":"A Phase Ib/II Study of LEE011 in Combination With MEK162 in Patients With NRAS Mutant Melanoma","official_title":"A Phase Ib/II, Multicenter, Open Label, Study of LEE011 in Combination With MEK162 in Adult Patients With NRAS Mutant Melanoma","primary_completion_date":"2018-01-15","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-02-20","last_update":"2020-12-07","description":"In the phase Ib, the primary purpose is to establish the maximum tolerated dose (MTD)(s)/recommended phase ll dose (RP2D) and schedule of LEE011 and MEK162 orally administered combination. Once the MTD(s)/RP2D have been determined for each tested schedule, additional patients will be enrolled in the phase II portion of the study at the RP2D on the chosen schedule in order to assess the anti-tumor activity of the combination in addition to continued evaluation of safety.","other_id":"CMEK162X2114","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of\r\n             0 - 1.\r\n\r\n          -  Patients enrolled into phase Ib may be enrolled with evaluable disease only. Patients\r\n             enrolled into the phase II expansion must have at least one measurable lesion as\r\n             defined by RECIST 1.1 criteria for solid tumors.\r\n\r\n          -  Patients must have adequate organ function, as defined by the following parameter\r\n\r\n               1. Absolute Neutrophil Count (ANC)  1.5 x 109/L.\r\n\r\n               2. Hemoglobin (Hgb)  9 g/dL.\r\n\r\n               3. Platelets  75 x 109/L without transfusions within 21 days before 1st treatment.\r\n\r\n               4. PT/INR and aPTT  1.5 ULN.\r\n\r\n               5. Serum creatinine 1.5 ULN.\r\n\r\n               6. Serum total bilirubin  1.5 x upper limit of normal (ULN).\r\n\r\n               7. AST and ALT  3 x ULN, except in patients with tumor involvement of the liver who\r\n                  must have AST and ALT  5 x ULN.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Presence of any brain metastases detected by MRI or CT with i.v. contrast of the brain\r\n             at screening.\r\n\r\n          -  Uncontrolled arterial hypertension despite medical treatment\r\n\r\n          -  Impaired cardiac function or clinically significant cardiac diseases, including any of\r\n             the following:\r\n\r\n               1. Left ventricular ejection fraction (LVEF) < 50% as determined by multiple gated\r\n                  acquisition scan (MUGA) or echocardiogram (ECHO).\r\n\r\n               2. Congenital long QT syndrome or family history of unexpected sudden cardiac death.\r\n\r\n               3. QTcF corrected with Frederica's or Bazett's formula QTcB >450 ms for males and\r\n                  >470 ms for females on screening ECG.\r\n\r\n               4. Angina pectoris  3 months prior to starting study drug\r\n\r\n               5. Acute myocardial infarction  3 months prior to starting study drug\r\n\r\n               6. Clinically significant resting bradycardia\r\n\r\n               7. History or presence of ventricular tachyarrhythmia\r\n\r\n               8. Unstable atrial fibrillation (ventricular response >100 bpm)\r\n\r\n               9. Complete left bundle branch block\r\n\r\n              10. Right bundle branch block and left anterior hemi block (bifascicular block)\r\n\r\n              11. Obligate use of a cardiac pacemaker or implantable cardioverter defibrillator\r\n\r\n              12. Any other clinically significant heart disease\r\n\r\n          -  Patients who are currently receiving treatment with agents that are known to cause QTc\r\n             prolongation in humans.\r\n\r\n          -  Patients who have neuromuscular disorders that are associated with elevated CK (e.g.,\r\n             inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal\r\n             muscular atrophy) or elevated baseline CK levels ( Grade 2)\r\n\r\n          -  Patients who are currently receiving treatment with agents that are metabolized\r\n             predominantly through CYP3A4 and that have a narrow therapeutic window.\r\n\r\n          -  Patients with concurrent severe and/or uncontrolled concurrent medical conditions that\r\n             could compromise participation in the study (i.e. uncontrolled diabetes mellitus,\r\n             clinically significant pulmonary disease, clinically significant neurological\r\n             disorder, active or uncontrolled infection).\r\n\r\n          -  History or current evidence of retinal vein occlusion (RVO) or current risk factors\r\n             for RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity\r\n             or hypercoagulability syndromes).\r\n\r\n        Other protocol related inclusion/exclusion criteria may apply.\r\n      ","sponsor":"Pfizer","sponsor_type":"Industry","conditions":"Locally Advanced or Metastatic NRAS Mutant Melanoma","interventions":[{"intervention_type":"Drug","name":"Drug: LEE011","description":"LEE011 will be administered orally once daily"},{"intervention_type":"Drug","name":"Drug: MEK162","description":"MEK162 will be administered orally twice daily"}],"outcomes":[{"outcome_type":"secondary","measure":"Plasma Concentration-time Profile (T1/2,ss) of LEE011 (Phase Ib)","time_frame":"For the 28-day schedule the steady-state parameter time frame was Cycle 1 Day 21, and for the 21-day schedule the steady-state parameter time frame was Cycle 1 Day 14","description":"To Characterize the PK profiles of LEE011 as well as any other significant metabolites identified (Phase Ib)."},{"outcome_type":"primary","measure":"Number of Dose Limiting Toxicities (Phase Ib)","time_frame":"first 28 days of treatment","description":"To estimate the maximum tolerate doses (MTDs) and/or identify the RP2D and schedule of LEE011 and MEK162 combination. A dose-limiting toxicity (DLT) was defined as an AE or clinically significant abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within the first cycle of treatment with ribociclib and binimetinib."},{"outcome_type":"primary","measure":"Objective Response Rate (ORR) (Phase II)","time_frame":"Approximately 12 months after the FPFV","description":"ORR is the proportion of patients with best overall response of complete response (CR) or partial response (PR) by month 2 assessed according to RECIST 1.1 criteria. ORR is done to describe the anti-tumor activity of LEE011 and MEK162 combination. The primary analysis of the ORR was based on the Investigator's assessment of overall lesion responses per RECIST 1.1."},{"outcome_type":"secondary","measure":"Plasma Concentration-time Profile (AUCtau) of LEE011 (Phase Ib)","time_frame":"Cycle 1 Day 1","description":"To Characterize the PK profiles of LEE011 as well as any other significant metabolites identified (Phase Ib)."},{"outcome_type":"secondary","measure":"Plasma Concentration-time Profile (AUCtau) of MEK162 (Phase Ib)","time_frame":"Cycle 1 Day 1","description":"To Characterize the PK profiles of MEK162 as well as any other significant metabolites identified (Phase Ib)."},{"outcome_type":"secondary","measure":"Plasma Concentration-time Profile (AUCtau,ss) of LEE011 (Phase Ib)","time_frame":"For the 28-day schedule the steady-state parameter time frame was Cycle 1 Day 21, and for the 21-day schedule the steady-state parameter time frame was Cycle 1 Day 14","description":"To Characterize the PK profiles of LEE011 as well as any other significant metabolites identified (Phase Ib)."},{"outcome_type":"secondary","measure":"Plasma Concentration-time Profile (AUCtau,ss) of MEK162 (Phase Ib)","time_frame":"For the 28-day schedule the steady-state parameter time frame was Cycle 1 Day 21, and for the 21-day schedule the steady-state parameter time frame was Cycle 1 Day 14","description":"To Characterize the PK profiles of MEK162 as well as any other significant metabolites identified (Phase Ib)."},{"outcome_type":"secondary","measure":"Plasma Concentration-time Profile (Cmin,ss) of LEE011 (Phase Ib)","time_frame":"For the 28-day schedule the steady-state parameter time frame was predose on Cycle 1 Day 21, and for the 21-day schedule the steady-state parameter time frame was predose on Cycle 1 Day 14","description":"To Characterize the PK profiles of LEE011 as well as any other significant metabolites identified (Phase Ib)."},{"outcome_type":"secondary","measure":"Plasma Concentration-time Profile (Cmin,ss) of MEK162 (Phase Ib)","time_frame":"For the 28-day schedule the steady-state parameter time frame was predose on Cycle 1 Day 21, and for the 21-day schedule the steady-state parameter time frame was predose on Cycle 1 Day 14","description":"To Characterize the PK profiles of MEK162 as well as any other significant metabolites identified (Phase Ib)."},{"outcome_type":"secondary","measure":"Plasma Concentration-time Profile (Cmax) of LEE011 (Phase Ib)","time_frame":"Cycle 1 Day 1","description":"To Characterize the PK profiles of LEE011 as well as any other significant metabolites identified (Phase Ib)."},{"outcome_type":"secondary","measure":"Plasma Concentration-time Profile (Cmax) of MEK162 (Phase Ib)","time_frame":"Cycle 1 Day 1","description":"To Characterize the PK profiles of MEK162 as well as any other significant metabolites identified (Phase Ib)."},{"outcome_type":"secondary","measure":"Plasma Concentration-time Profile (Cmax,ss) of LEE011 (Phase Ib)","time_frame":"For the 28-day schedule the steady-state parameter time frame was Cycle 1 Day 21, and for the 21-day schedule the steady-state parameter time frame was Cycle 1 Day 14","description":"To Characterize the PK profiles of LEE011 as well as any other significant metabolites identified (Phase Ib)."},{"outcome_type":"secondary","measure":"Plasma Concentration-time Profile (Cmax,ss) of MEK162 (Phase Ib)","time_frame":"For the 28-day schedule the steady-state parameter time frame was Cycle 1 Day 21, and for the 21-day schedule the steady-state parameter time frame was Cycle 1 Day 14","description":"To Characterize the PK profiles of MEK162 as well as any other significant metabolites identified (Phase Ib)."},{"outcome_type":"secondary","measure":"Plasma Concentration-time Profile (Tmax) of LEE011 (Phase Ib)","time_frame":"Cycle 1 Day 1","description":"To Characterize the PK profiles of LEE011 as well as any other significant metabolites identified (Phase Ib)."},{"outcome_type":"secondary","measure":"Plasma Concentration-time Profile (Tmax) of MEK162 (Phase Ib)","time_frame":"Cycle 1 Day 1","description":"To Characterize the PK profiles of MEK162 as well as any other significant metabolites identified (Phase Ib)."},{"outcome_type":"secondary","measure":"Plasma Concentration-time Profile (Tmax,ss) of LEE011 (Phase Ib)","time_frame":"For the 28-day schedule the steady-state parameter time frame was Cycle 1 Day 21, and for the 21-day schedule the steady-state parameter time frame was Cycle 1 Day 14","description":"To Characterize the PK profiles of LEE011 as well as any other significant metabolites identified (Phase Ib)."},{"outcome_type":"secondary","measure":"Plasma Concentration-time Profile (Tmax,ss) of MEK162 (Phase Ib)","time_frame":"For the 28-day schedule the steady-state parameter time frame was Cycle 1 Day 21, and for the 21-day schedule the steady-state parameter time frame was Cycle 1 Day 14","description":"To Characterize the PK profiles of MEK162 as well as any other significant metabolites identified (Phase Ib)."},{"outcome_type":"secondary","measure":"Plasma Concentration-time Profile (Accumulation Ratio, Racc_AUC) of LEE011 (Phase Ib)","time_frame":"For the 28-day schedule the steady-state parameter time frame was Cycle 1 Day 21, and for the 21-day schedule the steady-state parameter time frame was Cycle 1 Day 14","description":"To Characterize the PK profiles of LEE011 as well as any other significant metabolites identified (Phase Ib)."},{"outcome_type":"secondary","measure":"Plasma Concentration-time Profile (Accumulation Ratio, Racc_AUC) of MEK162 (Phase Ib)","time_frame":"For the 28-day schedule the steady-state parameter time frame was Cycle 1 Day 21, and for the 21-day schedule the steady-state parameter time frame was Cycle 1 Day 14","description":"To Characterize the PK profiles of MEK162 as well as any other significant metabolites identified (Phase Ib)."},{"outcome_type":"secondary","measure":"Plasma Concentration-time Profile (T1/2,ss) of MEK162 (Phase Ib)","time_frame":"For the 28-day schedule the steady-state parameter time frame was Cycle 1 Day 21, and for the 21-day schedule the steady-state parameter time frame was Cycle 1 Day 14","description":"To Characterize the PK profiles of MEK162 as well as any other significant metabolites identified (Phase Ib)."},{"outcome_type":"secondary","measure":"Plasma Concentration-time Profile (CL/F) of LEE011 (Phase Ib)","time_frame":"Cycle 1 Day 1","description":"To Characterize the PK profiles of LEE011 as well as any other significant metabolites identified (Phase Ib)."},{"outcome_type":"secondary","measure":"Plasma Concentration-time Profile (CL/F) of MEK162 (Phase Ib)","time_frame":"Cycle 1 Day 1","description":"To Characterize the PK profiles of MEK162 as well as any other significant metabolites identified (Phase Ib)."},{"outcome_type":"secondary","measure":"Number of Participants With Adverse Drug Reactions","time_frame":"Approximately 12 months after FPFV","description":"Safety and tolerability will be characterized through the incidence and severity of adverse drug reactions, serious adverse drug reactions, changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs), dose interruptions, dose reduction and dose intensity."},{"outcome_type":"secondary","measure":"Duration of Response (DoR) - Phase 2","time_frame":"Approximately 12 months after the FPFV","description":"To assess clinical safety as per RECIST 1.1. Evaluation will occur continuously throughout the trial until progression, or death due to underlying cancer.\r\nPlease note: As clinicaltrials.gov only allows numerical data entry, the value of 999 indicates \"not estimable\" for confidence interval."},{"outcome_type":"secondary","measure":"Time to Progression (TTP) - Phase 2","time_frame":"Approximately 12 months after the FPFV","description":"To assess clinical safety as per RECIST 1.1. Evaluation will occur continuously throughout the trial until progression, or death due to underlying cancer."},{"outcome_type":"secondary","measure":"Progression Free Survival (PFS) - Phase 1b and Phase 2","time_frame":"Approximately 12 months after the FPFV","description":"To assess clinical safety as per RECIST 1.1. Evaluation will occur continuously throughout the trial until progression, or death due to underlying cancer.\r\nIn the Phase 1b part, patients were combined for purposes of PFS analyses based on schedule received, since too few patients received any individual dose level to allow for valid PFS estimates within the respective dose levels. This is how the data were analyses and presented for the clinical study report."},{"outcome_type":"secondary","measure":"Overall Survival (OS) - Phase ll","time_frame":"Approximately 12 months after the FPFV","description":"To assess clinical safety as per RECIST 1.1. Evaluation will occur continuously throughout the trial until progression, or death due to underlying cancer."},{"outcome_type":"secondary","measure":"Best Overall Response (BOR) - Phase II","time_frame":"Approximately 12 months after the FPFV","description":"To assess clinical safety according to RECIST 1.1. Evaluation will occur continuously throughout the trial until progression, or death due to underlying cancer."}]}
{"nct_id":"NCT01865409","start_date":"2013-06-30","phase":"N/A","enrollment":30,"brief_title":"Effect of Kangaroo Care on Heart Rate Variability","official_title":"Does Kangaroo Care Effects on Heart Rate Variability in Neonates","primary_completion_date":"2014-09-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2014-09-30","last_update":"2014-09-09","description":"Physiological processes leading to a preterm infant to be able to feed orally has not been fully understood. The investigators hypothesized that maturation of autonomic nervous system may play a major role in this process and kangaroo care may accelerate this maturation. The investigators will use heart rate variability to measure the maturation of autonomic nervous system.","other_id":"B 30 FTH 0 20 00 00 / 1503","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":0.61538,"maximum_age":0.67308,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Premature infants between 32 t0 35 weeks old\r\n\r\n          -  After 7 days of extra-uterine life\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Sepsis, infection\r\n\r\n          -  Cardiac disease\r\n\r\n          -  Intraventricular hemorrhage, patent ductus arteriosus, necrotizing enterocolitis\r\n      ","sponsor":"Fatih University","sponsor_type":"Other","conditions":"Immaturity|Oral Intolerance|Postnatal Adaptation","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Kangaroo Care","description":"Kangaroo care is a technique practiced on newborn, usually preterm, infants wherein the infant is held, skin-to-skin, with an adult."}],"outcomes":[{"outcome_type":"primary","measure":"HRV-Sympathetic-Short Measurement-LF","time_frame":"5 Minutes","description":"By using Holter monitorization for 24 haur. LF (frequency domain, low frequency measurement): The low-frequency (LF) spectra represents predominantly sympathetic with some parasympathetic influence in the 0.04-to-0.15 Hz range."},{"outcome_type":"secondary","measure":"Time Domain Measurements of HRV","time_frame":"5 Minutes","description":"By using Holter monitorization for 24 haur, 5 different measurements get by 5 minutes heart rate analysis: SDNN, SDANN,SDNN index,Rmssd,pNN50 SDNN: ms, Standard deviation of all NN intervals. SDANN: ms Standard deviation of the averages of NN intervals in all 5 min segments of the entire recording.\r\nSDNN index: ms, mean of the standard deviations of all NN intervals for all 5 min segments of the entire recording RMSSD: ms, The square root of the mean of the sum of the squares of diVerences between adjacent NN intervals.\r\npNN50: % NN50 count divided by the total number of all NN intervals"}]}
{"nct_id":"NCT01884272","start_date":"2013-06-30","phase":"Phase 1","enrollment":24,"brief_title":"NSAID Drug Interaction Study","official_title":"A Phase 1 Study to Evaluate the Potential Two-Way Pharmacokinetic Interaction Between Lesinurad and Naproxen and Between Lesinurad and Indomethacin in Healthy Adult Male Subjects","primary_completion_date":"2013-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-10-31","last_update":"2013-11-08","description":"This is a drug-drug interaction study in healthy volunteers to evaluate the potential pharmacokinetic (PK) effects of non-steroidal anti-inflammatory drugs on lesinurad and leinurad on the non-steroidal anti-inflammatory drugs.","other_id":"RDEA594-126","allocation":"Non-Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subject has a body weight  50 kg (110 lbs) and a body mass index (BMI)  18 and  30\r\n             kg/m2.\r\n\r\n          -  Subject is free of any clinically significant disease that requires a physician's care\r\n             and/or would interfere with study evaluations or procedures.\r\n\r\n          -  Subject has no clinically relevant abnormalities in vital signs, ECG, physical\r\n             examination or safety laboratory values.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subject has clinically significant pulmonary, cardiovascular, gastrointestinal,\r\n             neurologic, hepatic, renal, urological, or psychiatric disorders.\r\n\r\n          -  Subject has a history or suspicion of kidney stones.\r\n\r\n          -  Subject has a history of asthma.\r\n\r\n          -  Subject has undergone major surgery within 3 months prior to Day 1.\r\n\r\n          -  Subject has donated blood or experienced significant blood loss (> 450 mL) within 12\r\n             weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to the Screening\r\n             visit.\r\n\r\n          -  Subject has inadequate venous access or unsuitable veins for repeated venipuncture.\r\n      ","sponsor":"Ardea Biosciences, Inc.","sponsor_type":"Industry","conditions":"Gout","interventions":[{"intervention_type":"Drug","name":"Drug: lesinurad 400 mg"},{"intervention_type":"Drug","name":"Drug: naproxen 250 mg"},{"intervention_type":"Drug","name":"Drug: indomethacin 25 mg"}],"outcomes":[{"outcome_type":"primary","measure":"PK profile of lesinurad from plasma and urine","time_frame":"Day 1, Day 6 (urine only), Day 7, Day 14","description":"Profile in terms of AUC, Tmax, Cmax, and t1/2 AUC: area under the plasma concentration versus time curve; Tmax: time to maximum plasma concentration; Cmax: maximum plasma drug concentration; t1/2: apparent terminal half-life"},{"outcome_type":"primary","measure":"PK profile of naproxen and indomethacin from plasma and urine","time_frame":"Day 1, Day 6 (urine only), Day 7, Day 14","description":"Profile in terms of AUC, Tmax, Cmax, and t1/2"},{"outcome_type":"secondary","measure":"Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters","time_frame":"13 weeks"}]}
{"nct_id":"NCT01864668","start_date":"2013-06-30","enrollment":25,"brief_title":"the Influence of Tidal Volume to Lung Strain","official_title":"the Influence of Different Tidal Volume to Lung Strain of ARDS Patients","primary_completion_date":"2014-03-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2014-03-31","last_update":"2014-02-11","description":"Measure the lung strain in different tidal volume in ADRS patients to find the relationship between tidal volume and lung strain and find the most suitable tidal volume for each patient.","other_id":"20130519","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":85,"population":"Critical patients diagnosed with acute respiratory distress syndrome","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age:18-85,gender is not limited\r\n\r\n          2. Needing Invasive ventilation\r\n\r\n          3. Fit the definition of ARDS in 2012 \"Berlin Definition\"\r\n\r\n          4. Sign the paper of informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. pregnancy and at the end stage of tumour\r\n\r\n          2. the COPD patients\r\n\r\n          3. less than 24h of mechanical ventilation\r\n\r\n          4. more than 5 days of mechanical ventilation\r\n\r\n          5. FiO2>80%\r\n\r\n          6. presence of air leaks\r\n\r\n          7. organ dysfunction and hemodynamic instability\r\n\r\n          8. including in other research\r\n      ","sponsor":"Zhongda Hospital","sponsor_type":"Other","conditions":"Critically Ill|Acute Respiratory Distress Syndrome","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"the strain in different tidal volume","time_frame":"2 hours","description":"Use the GE ventilator to measure the EELV and calculate the lung strain(lung strain = VT/EELV)"},{"outcome_type":"secondary","measure":"28 days mortality","time_frame":"28 days","description":"Follow up to determine the mortality in 28 days after inclusion"}]}
{"nct_id":"NCT01862120","start_date":"2013-06-27","phase":"Phase 2","enrollment":24,"brief_title":"Dose Finding Study of Il-2 at Ultra-low Dose in Children With Recently Diagnosed Type 1 Diabetes","official_title":"Induction of Regulatory T Cells for the Treatment of Recently Diagnosed Type 1 Diabetes: Dose Finding Study of the Lowest Active Dose of IL-2 in Children","primary_completion_date":"2016-07-08","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-03-16","last_update":"2020-11-12","description":"Human recombinant interleukin-2 (rhIL-2) is a biological signalling protein playing a key role in the regulation of the immune system. At high doses, rhIL-2 activates the immune effectors T cells (TEFFS) while at low doses rhIL-2 induces and activates regulatory T cells (TREGS), a population of immune cells controlling the immune Teff response. In patients with Type 1 Diabetes (T1D), TREGS fail to control the autoimmune destruction by TEFFS of pancreatic beta-cells producing insulin. The investigator recently showed that rhIL-2 at low dose is well tolerated in patients with an autoimmune disease and in adults with established T1D, inducing TREGS without effects on TEFFS. The investigators aim to use rhIL-2 at low dose to induce/stimulate TREGS in young recently diagnosed T1D patients. This study will investigate the dose effect relationship of low dose rhIL-2 on TREG induction such as to optimize the risk benefit ratio of this treatment in T1D. Through Treg induction, the investigators aim to protect the remaining/regenerating pancreatic -cells from autoimmune destruction, thus improving or even curing T1D.","other_id":"P101106","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":7,"maximum_age":14,"population":"","criteria":"\n        Inclusion criteria :\r\n\r\n          -  Age [7-13] years for girls and [7-14] years for boys\r\n\r\n               -  With a T1D diagnosis (as ADA)\r\n\r\n               -  Treated with insulin for  3 months,\r\n\r\n               -  With at least one auto-antibody among: anti-insulin, anti-GAD, anti-IA2,\r\n                  anti-ZnT8 ;\r\n\r\n          -  No clinically relevant abnormal findings for haematology, biochemistry, liver and\r\n             kidney functions\r\n\r\n          -  Informed consent signed by the patient, the parents, and the investigator before any\r\n             intervention necessary for the trial.\r\n\r\n        Exclusion criteria :\r\n\r\n          -  Contra-indications to IL-2 :\r\n\r\n               -  Hyper sensibility to IL-2 or its excipients,\r\n\r\n               -  Severe cardiopathy\r\n\r\n               -  Previous organ allograft\r\n\r\n               -  Ongoing infection requiring antibiotherapy,\r\n\r\n               -  O2 Saturation  90 %\r\n\r\n               -  Severe impairment of any vital organ\r\n\r\n               -  Documented history of other auto-immune diseases (except for auto-antibodies for,\r\n                  IAA, GADA, IA-2A, anti-ZnT8A, and stable thyroiditis with normal TSH (<10 mUI/L),\r\n                  T3 and, T4 levels.\r\n\r\n               -  Diabetes onset characteristics including:\r\n\r\n                    -  Continuous nocturnal polyuria  3 months ;\r\n\r\n                    -  Inaugural acidosis (with venous Ph < 7.25) ;\r\n\r\n                    -  HbA1c at diagnostic  13%;\r\n\r\n                    -  Weight loss  10 % at diagnosis ;\r\n\r\n                    -  Positive autoantibodies to 21-hydroxylase\r\n\r\n                    -  Stage 2 obesity\r\n\r\n          -  Non authorized concomitant treatment : immuno-modulators, cytotoxic drugs, drug\r\n             modifying plasma glycemia\r\n\r\n          -  vaccination  4 weeks with life vaccin\r\n\r\n          -  Positive serology (IgM) to the Epstein-Barr virus (EBV) and/or cytomegalovirus (CMV),\r\n             reflecting an acute infection.\r\n\r\n          -  Participation to another clinical investigation in previous 3 months\r\n\r\n          -  No affiliation to National Health Insurance\r\n      ","sponsor":"Assistance Publique - Hpitaux de Paris","sponsor_type":"Other","conditions":"Type 1 Diabetes","interventions":[{"intervention_type":"Drug","name":"Drug: Dose D1 of interleukin-2","description":"subcutaneous injection of Interleukin-2 during 5 days, once daily repeated administration(Induction period). At day 15 single administration of Interleukin-2 every two weeks during one year (maintenance period)."},{"intervention_type":"Drug","name":"Drug: placebo","description":"subcutaneous injection of Interleukin-2 during 5 days, once daily repeated administration(Induction period). At day 15 single administration of Interleukin-2 every two weeks during one year (maintenance period)."},{"intervention_type":"Drug","name":"Drug: Dose D2 of Interleukin-2","description":"subcutaneous injection of Interleukin-2 during 5 days, once daily repeated administration(Induction period). At day 15 single administration of Interleukin-2 every two weeks during one year (maintenance period)."},{"intervention_type":"Drug","name":"Drug: Dose D3 of interleukin-2","description":"subcutaneous injection of Interleukin-2 during 5 days, once daily repeated administration(Induction period). At day 15 single administration of Interleukin-2 every two weeks during one year (maintenance period)."}],"outcomes":[{"outcome_type":"secondary","measure":"Treg response during the maintenance period compare to the baseline","time_frame":"day 15, day 29, day 43, day 99, day 183, day 267","description":"Treg response expressed as the % / CD4 will be measured several times"},{"outcome_type":"primary","measure":"Treg response following the induction cure period","time_frame":"day 5","description":"expressed as % total CD4 cells"},{"outcome_type":"secondary","measure":"Fasting plasma concentration of C-peptide","time_frame":"at Day 0, 99, 183, 267, 351, 436"},{"outcome_type":"secondary","measure":"C-peptide AUC response to a mixed meal tolerance test","time_frame":"at baseline, at months 6, 12, 15"},{"outcome_type":"secondary","measure":"IDAA1C score","time_frame":"at baseline, at months 3, 6, 9, 12, 15","description":"is a score defined as A1C (percent) + [4 x insulin dose (units per kilogram per 24 h)] without unit"},{"outcome_type":"secondary","measure":"HbA1c","time_frame":"at baseline, at months 3, 6, 9, 12, 15"},{"outcome_type":"secondary","measure":"Treg response after the last administration","time_frame":"day 351, day 436"}]}
{"nct_id":"NCT03405259","start_date":"2013-06-26","phase":"N/A","enrollment":22,"brief_title":"A Clinical Study to Compare Professional Treatments for Dentinal Hypersensitivity","official_title":"A Pilot Clinical Study to Compare Professional Treatments for Dentinal Hypersensitivity","primary_completion_date":"2013-09-13","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-09-13","last_update":"2019-06-17","description":"The objective of this study is to compare professional treatments for dentinal hypersensitivity immediately following a single, professionally-applied treatment and again approximately 2 months following treatment.","other_id":"2013077","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  be at least 18 years of age;\r\n\r\n          -  provide written informed consent prior to participation and be given a signed copy of\r\n             the informed consent form;\r\n\r\n          -  be in good general health as determined by the Investigator/designee; and\r\n\r\n          -  have at least one tooth with a VAS score of greater than or equal to 30 in response to\r\n             the air challenge.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  allergy to rosin or to pine nuts;\r\n\r\n          -  self-reported pregnancy or nursing;\r\n\r\n          -  severe periodontal disease, as characterized by purulent exudate, generalized\r\n             mobility, and/or severe recession;\r\n\r\n          -  active treatment for periodontitis;\r\n\r\n          -  fixed facial orthodontic appliances;\r\n\r\n          -  any diseases or conditions that might interfere with the safe completion of the study;\r\n             or\r\n\r\n          -  an inability to undergo any study procedures.\r\n      ","sponsor":"Procter and Gamble","sponsor_type":"Industry","conditions":"Dentinal Hypersensitivity","interventions":[{"intervention_type":"Device","name":"Device: Super Seal Desensitizer","description":"Single dose professional application."},{"intervention_type":"Device","name":"Device: Acclean Fluoride Varnish","description":"Single dose professional application."}],"outcomes":[{"outcome_type":"primary","measure":"Change From Baseline Air Challenge","time_frame":"Within 5 minutes after treatment was applied","description":"The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A negative change from Baseline score represents a decrease in sensitivity from baseline.The mean change from Baseline was calculated for this measure."},{"outcome_type":"primary","measure":"Change From Baseline Visual Analog Scale","time_frame":"Within 5 minutes after treatment was applied","description":"Visual Analog Scale (VAS) - subjects are asked to look at a VAS and designate the level of hypersensitivity they experienced as a result of the thermal and water challenges using a continuum scale of 0 = No tooth pain up to 100 = Worst tooth pain ever experienced. A negative change from Baseline score represents a decrease in sensitivity from baseline."}]}
{"nct_id":"NCT01878006","start_date":"2013-06-13","phase":"Phase 2","enrollment":15,"brief_title":"Genetic Effects on Dopamine Response to an Opiate","official_title":"OPRM1 A118G SNP Effect on Striatal Dopamine Response to an IV Opiate","primary_completion_date":"2017-04-27","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-04-27","last_update":"2021-04-01","description":"Background: - Small differences in genes may alter responses to drugs. One gene that has different forms is the mu opioid receptor gene. People with one form of this gene are more sensitive to alcohol. People with a different form are sometimes more sensitive to pain. Morphine and other prescription pain pills produce pain relief by acting at the mu opioid receptor. Researchers want to see the effect of morphine on brain reward and subjective effects. Morphine is a strong but short-acting pain medication that is sometimes used for anesthesia during surgery. Objectives: - To compare the effect of morphine on brain measures of dopamine release using imaging. Eligibility: - Individuals between 21 and 55 years of age who have previously taken pain pills prescribed to treat pain from a medical or dental procedure. Design: - This study has a screening phase and a study phase. The screening phase involves one or two visits of 5 to 6 hours. The study phase consists of 4 study visits. Each study visit will take about 8 hours. - Participants will be screened with a medical and psychiatric history and physical exam. They will be asked about drinking and drug-taking history, and any family history of alcoholism or drug abuse. Blood, urine, and breath samples will be collected. - During the first study visit, an MRI scan may be performed, questionnaires completed, and a blood sample collected for genetic testing. - During study visit 2, participants will test their pain sensitivity by placing one hand in cold water. Pupil diameter will be measured after the sensitivity test. After a blood sample is taken, participants will receive the morphine or a salt solution. The sensitivity test and pupil diameter test will be repeated. Final blood samples will be collected. A brief physical exam will also be performed. - During study visits 3 and 4, participants will receive morphine or a salt solution during a PET scan. Questionnaires to assess subjective effects will be administered. Final blood samples will be collected. A brief physical exam will also be performed. - Participants will stay in the clinic until the effects of the drug have worn off after study visits 2, 3, and 4. - About 1 week after the study session, participants will have a follow-up phone call.","other_id":"130061","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Other","masking_description":"Double","intervention_model_description":"Crossover study - participants receive active and placebo treatments in randomized order.","sampling_method":"","gender":"Male","minimum_age":21,"maximum_age":55,"population":"","criteria":"\n        -  INCLUSION CRITERIA:\r\n\r\n               1. Male participants between 21-55 years of age.\r\n\r\n               2. Good health as determined by medical history, physical exam, EKG and lab tests.\r\n\r\n               3. Current non-smokers or light smokers or e-cigarette users (<20 cig/week) who can\r\n                  easily abstain from smoking or using e-cigarettes for 1-2 days/week.\r\n\r\n               4. Current non-drinkers or social drinkers who do not meet past or current DSM IV\r\n                  criteria for alcohol abuse or alcohol dependence.\r\n\r\n               5. An equal number of final participants will be of OPRM1 118 A/A vs. 118A/G or\r\n                  118G/G genotype. This means that after the first group (n40) is complete then\r\n                  only participants with the required genotype for the other group will be\r\n                  included.\r\n\r\n               6. Prior opiate use, at least one experience with one of the opiates listed in\r\n                  Appendix 1 of the protocol.\r\n\r\n               7. Comprehension/fluency with English Language.\r\n\r\n        EXCLUSION CRITERIA:<TAB>\r\n\r\n          1. Current or prior history of any significant disease, including cardiovascular,\r\n             respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders,\r\n             or a positive hepatitis or HIV test at screening, disorders that could make\r\n             administration of an opiate more risky (e.g., asthma, COPD, sleep apnea, or other\r\n             breathing disorders; liver or kidney disease; thyroid disorder; trouble swallowing, or\r\n             a blockage in the digestive tract (stomach or intestines); neurologic disorders (e.g.,\r\n             a history of head injury or brain tumor, epilepsy or other seizure disorder, CVA,\r\n             migraine in treatment, etc.); low blood pressure; hypertension; neuromuscular\r\n             disorder; gallbladder disease; Addison's disease or other adrenal gland disorders;\r\n             enlarged prostate, urination problems)\r\n\r\n          2. Current Axis-I psychiatric illness as determined by the Structured Clinical Interview\r\n             for DSM IV disorders (SCID).\r\n\r\n          3. Current or prior history of any alcohol or drug dependence as determined by the\r\n             Structured Clinical Interview for DSM IV disorders (SCID).\r\n\r\n          4. Positive result on urine screen for illicit drugs.\r\n\r\n          5. Medication Use:\r\n\r\n               1. Current chronic prescription or over the counter medications or use of\r\n                  prescription or OTC medications known to interact with dopamine receptors within\r\n                  2 weeks of the study\r\n\r\n               2. Drugs known to inhibit or induce enzymes that metabolize opiates should not be\r\n                  used for 4 weeks prior to the study. These include chlorzoxazone, isoniazid,\r\n                  metronidazole and disulfiram.\r\n\r\n               3. Cough-and-cold preparations that contain anti-histamines or opiate pain medicines\r\n                  will be withheld for at least 72 hours prior to each study session.\r\n\r\n               4. Drugs that may interfere with the BOLD MRI signal within 2 weeks of the study.\r\n                  These include, but may not be limited to: muscle relaxants or respiratory,\r\n                  cardiovascular or anticonvulsant medications\r\n\r\n          6. Morbid obesity (BMI >40 kg/m2)\r\n\r\n          7. Previous negative effects of opioid administration\r\n\r\n          8. Presence of certain implanted devices (cardiac pacemaker or neurostimulator, some\r\n             artificial joints, metal pins, surgical clips or other implanted metal parts), body\r\n             morphology, or claustrophobia. Justification: Implanted devices may increase the risk\r\n             of MRI scanning and/or adversely affect the quality of the data; body morphology may\r\n             prevent optimal positioning in the scanner and thus affect the quality of the data;\r\n             participants with claustrophobia may find the MRI scan too unpleasant and may exhibit\r\n             excess movement that will adversely affect the quality of the data. Assessment\r\n             tool(s): Prospective participants will fill out an MRI screening questionnaire and\r\n             undergo an interview with an MR technologist. Questions concerning suitability for\r\n             scanning will be referred to the Medical Advisory Investigator. Prospective\r\n             participants will be questioned about symptoms of claustrophobia and placed in the\r\n             mock scanner during their first visit to assess for possible difficulty tolerating the\r\n             confinement of the scanner and for ability to fit into the scanner.\r\n\r\n          9. Conditions restricting participant's ability to lie flat for up to two hours (such as\r\n             coagulopathies, superficial or deep vein thrombosis, or musculoskeletal\r\n             abnormalities). Justification: PET scanning sessions require participants to lie flat\r\n             on their backs and remain perfectly still for approximately two hours. Therefore,\r\n             conditions that would make that difficult (e.g., chronic back pain, significant\r\n             scoliosis) or dangerous (e.g., familial hypercoagulability syndrome, history of\r\n             thrombosis) will be exclusionary. Assessment tool(s): History and physical examination\r\n             by a qualified IRP clinician, supplemented with a trial of lying in the mock scanner\r\n             to assess comfort.\r\n\r\n         10. Head trauma leading to loss of consciousness for more than 5 min or hospitalization\r\n\r\n         11. Exposure to ionizing radiation from research studies that, in combination with the\r\n             study tracer, would result in cumulative exposure of >5 rem within the previous 12\r\n             month period\r\n\r\n         12. Self-reported and/or observed signs, symptoms, or diagnosis of Raynaud's or Buerger's\r\n             disease (e.g., pain in hands or feet at times of rest, during/following cold exposure\r\n             or stress, any significant color changes in hands or toes). Additionally, medical\r\n             staff will be present to watch for these symptoms during the actual cold pressor test.\r\n      ","sponsor":"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","sponsor_type":"NIH","conditions":"Polymorphism-Genetic|Pain|Addiction","interventions":[{"intervention_type":"Drug","name":"Drug: Morphine"},{"intervention_type":"Drug","name":"Drug: Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"11C Raclopride Binding Potential in Caudate","time_frame":"90 minutes following injection","description":"Binding potential measured using regions-of-interest analysis of PET data. Parametric Binding Potential (BPND) images were obtained using the Simple Reference Tissue Model 2 (SRTM2), with cerebellum as the reference region. BPND is computed in units of mCi/ml reflecting the radioactivity (milliCuries or mCi) per unit volume (milliliters or ml) in specific brain regions. Reduction in raclopride binding is attributed to competition with endogenous dopamine, and has been shown to be proportional to the magnitude of Dopamine (DA) release."},{"outcome_type":"primary","measure":"11C Raclopride Binding Potential in Nucleus Accumbens","time_frame":"90 minutes following injection","description":"Binding potential measured using regions-of-interest analysis of PET data. Parametric Binding Potential (BPND) images were obtained using the Simple Reference Tissue Model 2 (SRTM2), with cerebellum as the reference region. BPND is computed in units of mCi/ml reflecting the radioactivity (milliCuries or mCi) per unit volume (milliliters or ml) in specific brain regions. Reduction in raclopride binding is attributed to competition with endogenous dopamine, and has been shown to be proportional to the magnitude of Dopamine (DA) release."},{"outcome_type":"primary","measure":"11C Raclopride Binding Potential in Putamen","time_frame":"90 minutes following injection","description":"Binding potential measured using regions-of-interest analysis of PET data. Parametric Binding Potential (BPND) images were obtained using the Simple Reference Tissue Model 2 (SRTM2), with cerebellum as the reference region. BPND is computed in units of mCi/ml reflecting the radioactivity (milliCuries or mCi) per unit volume (milliliters or ml) in specific brain regions. Reduction in raclopride binding is attributed to competition with endogenous dopamine, and has been shown to be proportional to the magnitude of Dopamine (DA) release."},{"outcome_type":"primary","measure":"11C Raclopride Binding Potential in Ventral Pallidum","time_frame":"90 minutes following injection","description":"Binding potential measured using regions-of-interest analysis of PET data. Parametric Binding Potential (BPND) images were obtained using the Simple Reference Tissue Model 2 (SRTM2), with cerebellum as the reference region. BPND is computed in units of mCi/ml reflecting the radioactivity (milliCuries or mCi) per unit volume (milliliters or ml) in specific brain regions. Reduction in raclopride binding is attributed to competition with endogenous dopamine, and has been shown to be proportional to the magnitude of Dopamine (DA) release."},{"outcome_type":"secondary","measure":"Subjective Perception of Morphine Effect - Feel Drug","time_frame":"60 minutes following injection","description":"Area under the curve of the subjective perception-time course - Feel Drug. Subjective responses as measured by the Drug Effects Questionnaire [DEQ]. The DEQ consists of simple, face-valid, visual analog scale (VAS) questions on which people report their subjective states after ingesting a substance. The analog scale of responses ranges from \"not at all\" to \"extremely\", and the numeric scale ranges from 0 to 100. Due to skewness of individual time points; areas under the curve (AUC) for these ratings across individual time points (0, 10, 20, 30, 40, 50 and 60 min) were compared. AUC is computed using the trapezoidal rule and has a range of values from 0 to 5500, where 0 reflects no subjective perception at any time point and 5500 reflects maximal subjective perception (score of 100) at all time points after drug administration."},{"outcome_type":"secondary","measure":"Subjective Perception of Morphine Effect - Feel High","time_frame":"60 minutes following injection","description":"Area under the curve of the subjective perception-time course - Feel High. Subjective responses as measured by the Drug Effects Questionnaire [DEQ]. The DEQ consists of simple, face-valid, visual analog scale (VAS) questions on which people report their subjective states after ingesting a substance. The analog scale of responses ranges from \"not at all\" to \"extremely\", and the numeric scale ranges from 0 to 100. Due to skewness of individual time points; areas under the curve (AUC) for these ratings across individual time points (0, 10, 20, 30, 40, 50 and 60 min) were compared. AUC is computed using the trapezoidal rule and has a range of values from 0 to 5500, where 0 reflects no subjective perception at any time point and 5500 reflects maximal subjective perception (score of 100) at all time points after drug administration."},{"outcome_type":"secondary","measure":"Subjective Perception of Morphine Effect - Like Drug","time_frame":"60 minutes following injection","description":"Area under the curve of the subjective perception-time course - Like Drug. Subjective responses as measured by the Drug Effects Questionnaire [DEQ]. The DEQ consists of simple, face-valid, visual analog scale (VAS) questions on which people report their subjective states after ingesting a substance. The analog scale of responses ranges from \"not at all\" to \"extremely\", and the numeric scale ranges from 0 to 100. Due to skewness of individual time points; areas under the curve (AUC) for these ratings across individual time points (0, 10, 20, 30, 40, 50 and 60 min) were compared. AUC is computed using the trapezoidal rule and has a range of values from 0 to 5500, where 0 reflects no subjective perception at any time point and 5500 reflects maximal subjective perception (score of 100) at all time points after drug administration."},{"outcome_type":"secondary","measure":"Subjective Perception of Morphine Effect - Want More","time_frame":"60 minutes following injection","description":"Area under the curve of the subjective perception-time course - Want More. Subjective responses as measured by the Drug Effects Questionnaire [DEQ]. The DEQ consists of simple, face-valid, visual analog scale (VAS) questions on which people report their subjective states after ingesting a substance. The analog scale of responses ranges from \"not at all\" to \"extremely\", and the numeric scale ranges from 0 to 100. Due to skewness of individual time points; areas under the curve (AUC) for these ratings across individual time points (0, 10, 20, 30, 40, 50 and 60 min) were compared. AUC is computed using the trapezoidal rule and has a range of values from 0 to 5500, where 0 reflects no subjective perception at any time point and 5500 reflects maximal subjective perception (score of 100) at all time points after drug administration."}]}
{"nct_id":"NCT01848197","start_date":"2013-05-31","phase":"N/A","enrollment":1000,"brief_title":"Paclitaxol Every 2 Week Versus Paclitaxol Every 1 Week in the Adjuvant Treatment of Breast Cancer","official_title":"An Open, Randomized, Parallel-group, Multicenter Clinical Study to Evaluate Efficacy and Safety of Paclitaxel Every 2 Weeks Compared Weekly in Adjuvant Treatment of Breast Cancer","primary_completion_date":"2018-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2020-12-31","last_update":"2013-05-07","description":"RATIONALE: Adjuvant chemotherapy has been proven to reduce significantly the risk for relapse and death in women with operable breast cancer.In the North American Inter-Group factorial trial design (CALGB 9741) the concept of dosedense adjuvant chemotherapy was further tested in patients with node-positive breast cancer.Weekly paclitaxel after standard adjuvant chemotherapy with epirubicin and cyclophosphamide improves disease-free and overall survival in women with breast cancer.Investigators asked if dose-dense 2-week intertreatment intervals (supported by the use of granulocyte-colony stimulating factor) were better than the conventional inconvenient weekly intervals.","other_id":"ZJTC0001","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age between 18-70 years female operable breast cancer patients\r\n\r\n          2. Patients were required to register within 60 days from the final surgical procedure\r\n             required to adequately treat the invasive primary tumor.\r\n\r\n          3. women who had operable,histologically confirmed adenocarcinoma of the breast with a.\r\n             histologically involved positive lymph nodes b. or histologic diagnosis for three\r\n             negative patients; c. or lymph node negative, HER2 positive(if HER2 + +, FISH\r\n             (fluorescence in situ hybridization method)/CISH tests confirmed HER2 amplification is\r\n             positive),but unable or intolerant to herceptin combined chemotherapy.\r\n\r\n          4. Karnofsky points greater than or equal to 70.\r\n\r\n          5. Postmenopausal women or HCG test results were negative, Women of child-bearing\r\n             potential willing to use effective contraception during the study.\r\n\r\n          6. PATIENT CHARACTERISTICS:\r\n\r\n        Hematopoietic:\r\n\r\n          -  Neutrophil count at least 1,500/mm^3\r\n\r\n          -  Platelet count at least 100,000/mm^3\r\n\r\n        Hepatic:\r\n\r\n          -  Bilirubin no greater than 1.5 times upper limit of normal\r\n\r\n          -  TBIL no greater than 1.5 times upper limit of normal\r\n\r\n          -  AKP no greater than 2.5 times upper limit of normal\r\n\r\n          -  AST no greater than 2.5 times upper limit of normal\r\n\r\n          -  ALT no greater than 2.5 times upper limit of normal\r\n\r\n        Renal:\r\n\r\n          -  Creatinine no greater than 1.5 times upper limit of normal\r\n\r\n        Cardiovascular:\r\n\r\n          -  No history of myocardial infarction\r\n\r\n          -  No congestive heart failure\r\n\r\n          -  No significant ischemic or valvular heart disease\r\n\r\n        Other:\r\n\r\n          -  No other prior invasive malignancies within the past 5 years except curatively treated\r\n             basal or squamous cell skin cancer or carcinoma in situ of the cervix\r\n\r\n          -  No hypersensitivity to paclitaxel or docetaxel or other similarly formulated drugs\r\n             (with Cremophor or polysorbate)\r\n\r\n        Other protocol-defined inclusion/exclusion criteria may apply.\r\n\r\n        Exclusion Criteria:\r\n\r\n        -\r\n      ","sponsor":"Taizhou Hospital","sponsor_type":"Other","conditions":"Breast Cancer|Paclitaxel|Epirubicin|Cyclophosphamide","interventions":[{"intervention_type":"Drug","name":"Drug: paclitaxel"}],"outcomes":[{"outcome_type":"primary","measure":"disease-free survival","time_frame":"3 years","description":"time from randomization to disease recurrence (including death from recurrence if it was the first manifestation of recurrence), death without recurrence, or contralateral breast cancer."},{"outcome_type":"secondary","measure":"disease-free survival","time_frame":"5 years","description":"time from randomization to disease recurrence (including death from recurrence if it was the first manifestation of recurrence), death without recurrence, or contralateral breast cancer."},{"outcome_type":"secondary","measure":"overall survival","time_frame":"5 years","description":"time from randomization to disease death with/without recurrence breast cancer."},{"outcome_type":"other","measure":"Explore the relationship between neuropathy and DFS and the related predictive biomarkers (RWDD3 and TECTA gene SNP etc)","time_frame":"3 years"},{"outcome_type":"other","measure":"Explore predictive biomarker of neutropenia;","time_frame":"5 years"}]}
{"nct_id":"NCT02751307","start_date":"2013-05-31","phase":"Phase 4","enrollment":55,"brief_title":"Adjunctive Low-dose Metformin in Patients With Schizophrenia and Metabolic Abnormalities","official_title":"Treatment of Metabolic Abnormalities in Patients With Schizophrenia: Adjunctive Low-dose Metformin in Patients With Schizophrenia and Metabolic Abnormalities","primary_completion_date":"2015-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-01-31","last_update":"2016-04-28","description":"Metformin has been used for alleviating metabolic abnormalities in patients with schizophrenia. Until now, the lowest dose of metformin to treat metabolic abnormalities in clozapine-treated patients is 1000 mg/d. The aim of this study was to determine whether a lower dosage of metformin, such as 500 mg/d, is effective for improving metabolic profiles in clozapine-treated patients with pre-existing metabolic abnormalities. Methods: In this 12-week, randomized, double-blind, placebo-controlled trial, metformin 500 mg/d or 1000 mg/d or a placebo was prescribed to clozapine-treated patients with schizophrenia having pre-existing metabolic abnormalities. The recruited patients underwent physical and laboratory evaluations at week-4, week-8, and week-12.","other_id":"TMU-JIRB 201303005","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. patients diagnosed with schizophrenia or schizoaffective disorder according to the\r\n             Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition\r\n\r\n          2. aged 20-65 years\r\n\r\n          3. had taken clozapine for at least 3 months\r\n\r\n          4. had at least one of the following metabolic abnormalities: BMI  24; WC > 90 cm (men)\r\n             or 80 cm (women); fasting serum TG level  150 mg/dL; fasting serum HDL-C level  40\r\n             mg/dL (men) or 50 mg/dL (women); systolic BP  130 or diastolic BP  85 mm Hg; current\r\n             use of antihypertensive agents; and FPG level = 100-126 mg/dL.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. history of diabetes mellitus\r\n\r\n          2. current use of hypoglycemic or hypolipidemic agents\r\n\r\n          3. pregnancy\r\n\r\n          4. allergy to metformin\r\n\r\n          5. a creatinine level > 1.4 ng/dL\r\n\r\n          6. an abnormal liver function test result\r\n\r\n          7. chronic cardiopulmonary insufficiency.\r\n      ","sponsor":"Taipei Medical University WanFang Hospital","sponsor_type":"Other","conditions":"Metabolic Syndrome","interventions":[{"intervention_type":"Drug","name":"Drug: metformin 500 mg","description":"metformin 500 mg QAM for metformin 500 mg/d group; metformin 500 mg 1 BID for metformin 1000 mg/d"},{"intervention_type":"Drug","name":"Drug: clozapine 100 mg","description":"Clozapine dose remained unchanged during metformin intervention period in recruited patients."}],"outcomes":[{"outcome_type":"primary","measure":"Changes in body weight","time_frame":"baseline; week-4; week-8; week-12"},{"outcome_type":"secondary","measure":"Changes in waist circumference","time_frame":"baseline; week-4; week-8; week-12"},{"outcome_type":"secondary","measure":"Changes in blood pressure","time_frame":"baseline; week-4; week-8; week-12"},{"outcome_type":"secondary","measure":"Changes in fasting triglyceride level","time_frame":"baseline; week-4; week-8; week-12"},{"outcome_type":"secondary","measure":"Changes in fasting high-density lipoprotein cholesterol level","time_frame":"baseline; week-4; week-8; week-12"},{"outcome_type":"secondary","measure":"Changes in fasting glucose level","time_frame":"baseline; week-4; week-8; week-12"},{"outcome_type":"secondary","measure":"Changes in scores of positive and negative syndrome scale (PANSS)","time_frame":"baseline; week-4; week-8; week-12","description":"Recruited patients were interviewed by research assistants to get PANSS scores."}]}
{"nct_id":"NCT01809821","start_date":"2013-05-31","phase":"N/A","enrollment":134,"brief_title":"Sleep to Lower Elevated Blood Pressure","official_title":"Sleep to Lower Elevated Blood Pressure: A Randomised Controlled Trial","primary_completion_date":"2014-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-06-30","last_update":"2014-09-03","description":"Sleep is an essential component of good physical and mental health. Previous studies have reported that poor quality sleep is associated with an increased risk of hypertension, stroke and cardiovascular disease (CVD). Hypertension is the most common and important risk factor for CVD, and even modest reductions in blood pressure result in significant reductions in stroke and myocardial infarction. In this randomised trial, the investigators aim to evaluate whether a simple, multi-component, online sleep intervention reduces blood pressure in patients with essential hypertension.","other_id":"HRBCRFG-150213-EMG","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Signed written informed consent\r\n\r\n          -  18 years on entry to study\r\n\r\n          -  Average automated Systolic Blood Pressure (SBP) monitor readings between 130 - 160\r\n             mmHg with average automated Diastolic Blood Pressure(DBP) monitor readings <110 mmHg\r\n             on three occasions, measured in a valid standardized manner while seated, or average\r\n             Ambulatory Blood Pressure Monitor (ABPM) SBP reading between 130-160 mmHg with average\r\n             DBP reading <110 mmHg.\r\n\r\n          -  Self-reported difficulty getting to sleep (defined as usually taking more than 30 mins\r\n             to get to sleep), and/or staying asleep (usually waking up more than once per night)\r\n             for at least 3 months duration\r\n\r\n          -  Internet access and self-reported competency in using the internet\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Receiving > 2 antihypertensive medications, or recent change in antihypertensive\r\n             medications (within previous 2 months) or planned change in antihypertensive\r\n             medication in next 8 weeks\r\n\r\n          -  Previous history of myocardial infarction, ischaemic stroke or transient ischaemic\r\n             attack\r\n\r\n          -  Previous history of congestive heart failure\r\n\r\n          -  History of dialysis for chronic renal impairment or evidence of chronic kidney disease\r\n             (eGFR <60 or albuminuria).\r\n\r\n          -  Known history of diabetes mellitus\r\n\r\n          -  Current ongoing sleep hygiene education or sleep related cognitive behavioural therapy\r\n\r\n          -  Ongoing involvement in night shift work\r\n\r\n          -  History of obstructive sleep apnoea (OSA) and previously received or currently\r\n             receiving treatment for OSA (patients with a history of untreated OSA are eligible for\r\n             inclusion).\r\n\r\n          -  Known history of sleep disorders (i.e. narcolepsy; hypersomnias; parasomnias such as\r\n             sleep walking, night terrors, recurring nightmares; periodic limb movements/restless\r\n             leg syndrome; circadian rhythm sleep disorder)\r\n\r\n          -  Unable to follow educational advice in the opinion of the clinician\r\n\r\n          -  Baby or young children at home that wake during the night\r\n\r\n          -  History of bipolar affective disorder\r\n\r\n          -  History of psychosis\r\n\r\n          -  History of major depression (defined as depression requiring hospitalization in the\r\n             past or visit to psychiatry outpatient clinic in the past 3 months)\r\n\r\n          -  Unstable depression (unstable will be defined as changes in antidepressant medications\r\n             within the last 3 months - i.e. start, stop or change in dose.)\r\n\r\n          -  Unstable anxiety disorders/panic attacks (unstable will be defined as changes in\r\n             medications within the last 3 months - i.e. start, stop or change in dose.)\r\n\r\n          -  Ongoing substance or alcohol abuse\r\n\r\n          -  Planned surgery or hospitalization over the next 8 weeks (i.e. during the trial)\r\n\r\n          -  Incapacitating pain or illness or other medical condition in which, in the opinion of\r\n             the clinician, the sleep intervention is unlikely to be effective.\r\n      ","sponsor":"University College Hospital Galway","sponsor_type":"Other","conditions":"Hypertension|Sleep Disorders|Insomnia|Cardiovascular Diseases","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Online Sleep Education"}],"outcomes":[{"outcome_type":"primary","measure":"Systolic Blood Pressure","time_frame":"8 weeks","description":"To determine if the addition of a multi-component, online, sleep intervention to usual care (standard CV risk factor education), results in a greater reduction in mean 24-hr systolic blood pressure in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8-week period."},{"outcome_type":"secondary","measure":"Diastolic Outcome Measure","time_frame":"8 weeks","description":"Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with a greater reduction in mean 24-hr diastolic blood pressure in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8-week period?"},{"outcome_type":"secondary","measure":"Sleep efficiency","time_frame":"8 weeks","description":"Change in proportion of participants with sleep efficacy ≥ 85% at 8 weeks"},{"outcome_type":"secondary","measure":"Sleep onset latency","time_frame":"8 weeks","description":"Change in proportion of participants with sleep onset latency ≤ 30 minutes at 8 weeks"},{"outcome_type":"secondary","measure":"PSQI","time_frame":"8 weeks","description":"Change in proportion of participants with Pittsburgh Sleep Quality Index (PSQI) score <5 over 8 weeks"},{"outcome_type":"secondary","measure":"SCI","time_frame":"8 weeks","description":"Change in proportion of participants with sleep condition indicator (SCI) score ≤5.9 at 8 weeks"},{"outcome_type":"secondary","measure":"ISI","time_frame":"8 weeks","description":"Change in proportion of participants with Insomnia Severity index (ISI) score ≥15 at 8 weeks"},{"outcome_type":"other","measure":"Body Mass Index","time_frame":"8 weeks","description":"Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in body mass index in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?"},{"outcome_type":"other","measure":"Plasma lipoproteins","time_frame":"8 weeks","description":"Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in plasma lipids in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?"},{"outcome_type":"other","measure":"Plasma HbA1c","time_frame":"8 weeks","description":"Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in plasma HbA1c in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?"},{"outcome_type":"other","measure":"eGFR","time_frame":"8 weeks","description":"Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in eGFR in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?"},{"outcome_type":"other","measure":"Insomnia Severity Index","time_frame":"8 weeks","description":"Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in Insomnia Severity Index Score in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?"},{"outcome_type":"other","measure":"Sleep Condition Indicator Score","time_frame":"8 weeks","description":"Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in Sleep Condition Indicator Score in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?"},{"outcome_type":"other","measure":"Pittsburgh Sleep Quality Index","time_frame":"8 weeks","description":"Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in Pittsburgh Sleep Quality Index in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?"},{"outcome_type":"other","measure":"Mean number of cigarettes smoked","time_frame":"8 weeks","description":"Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in mean number of cigarettes smoked in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?"},{"outcome_type":"other","measure":"Sleep onset latency","time_frame":"8 weeks","description":"Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in sleep onset latency in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?"},{"outcome_type":"other","measure":"Wake time to sleep onset","time_frame":"8 weeks","description":"Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in wake time to sleep onset in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?"},{"outcome_type":"other","measure":"Sleep efficiency","time_frame":"8 weeks","description":"Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in sleep efficiency in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?"},{"outcome_type":"other","measure":"Beck Depression Inventory score","time_frame":"8 weeks","description":"Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in Beck Depression Inventory score in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?"},{"outcome_type":"other","measure":"Beck Anxiety Inventory score","time_frame":"8 weeks","description":"Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in Beck Anxiety Inventory score in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?"},{"outcome_type":"other","measure":"Smoking status","time_frame":"8 weeks","description":"Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with a change in smoking status compared to usual care alone, over an 8 week period?"},{"outcome_type":"other","measure":"Diastolic blood pressure","time_frame":"8 weeks","description":"Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with a change in daytime (peak and mean) diastolic blood pressure , compared to usual care alone, over an 8 week period?"},{"outcome_type":"other","measure":"Systolic blood pressure","time_frame":"8 weeks","description":"Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with a change in daytime (peak and mean) systolic blood pressure , compared to usual care alone, over an 8 week period?"},{"outcome_type":"other","measure":"Total Sleep Time","time_frame":"8 weeks","description":"Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with a change in Total Sleep Time , compared to usual care alone, over an 8 week period?"},{"outcome_type":"other","measure":"Diastolic blood pressure","time_frame":"8 weeks","description":"Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with a change in nighttime (peak and mean) diastolic blood pressure , compared to usual care alone, over an 8 week period?"},{"outcome_type":"other","measure":"Systolic blood pressure","time_frame":"8 weeks","description":"Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with a change in nighttime (peak and mean) systolic blood pressure , compared to usual care alone, over an 8 week period?"},{"outcome_type":"other","measure":"Systolic blood pressure","time_frame":"8 weeks","description":"Is the level of adherence to a multi-component online sleep intervention associated with a change in mean 24-hour SBP over 8 weeks"},{"outcome_type":"other","measure":"Systolic blood pressure","time_frame":"8 weeks","description":"To determine if concomitant use of antihypertensive medication influences the change in mean 24-hour SBP over 8 weeks ."}]}
{"nct_id":"NCT01873443","start_date":"2013-05-31","phase":"Phase 1","enrollment":87,"brief_title":"Long-Term Efficacy and Safety of CT-P10 in Patients With RA","official_title":"An Open-Label, Single-Arm, Maintenance Study to Demonstrate Long-Term Efficacy and Safety of CT-P10 in Patients With Rheumatoid Arthritis Who Were Treated With Rituximab (MabThera or CT-P10) in Study CT-P10 1.1","primary_completion_date":"2014-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-10-31","last_update":"2015-11-26","description":"This is an open-label, single-arm, multicenter, efficacy, and safety maintenance study of the Phase 1 Study CT-P10 1.1. This study is designed to assess the long-term efficacy and safety of CT-P10 co-administered with MTX and folic acid in patients with RA who have completed the scheduled visits in Study CT-P10 1.1","other_id":"CT-P10 1.3","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patient has disease improvement (moderate or good response) according to Disease\r\n             Activity Score using 28 joint counts (DAS28) during the last course of treatment in\r\n             Study CT-P10 1.1.\r\n\r\n          -  Patient has completed all of the scheduled visits in the Study CT-P10 1.1 Main Study\r\n             Period, including the Core Study Period and/or Extension Study Period.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patient has been withdrawn from Study CT-P10 1.1 for any reason.\r\n\r\n          -  Patient has, at the time of providing informed consent, any current medical issues\r\n             such as serious adverse events (SAEs) or current or previous intolerance issues that\r\n             mean continuation in this maintenance study could be detrimental to their health, in\r\n             the opinion of the investigator.\r\n      ","sponsor":"Celltrion","sponsor_type":"Industry","conditions":"Rheumatoid Arthritis","interventions":[{"intervention_type":"Drug","name":"Drug: Rituximab, MTX, folic acid","description":"Rituximab IV 1000mg MTX 10~25mg/week Folic acid at least 5mg/week"}],"outcomes":[{"outcome_type":"primary","measure":"Efficacy evaluation by ACR criteria and safety evaluation by hypersensitivity monitoring","time_frame":"8 week interval","description":"Efficacy will be assessed by evaluation of ACR criteria (ACR 20% , ACR 50% , ACR 70%, and hybrid ACR response), Safety will be assessed by evaluation of hypersensitivity monitoring via vital sign measurements (including blood pressure, heart and respiratory rates, and body temperature),etc,."}]}
{"nct_id":"NCT01785420","start_date":"2013-05-31","phase":"Phase 3","enrollment":1100,"brief_title":"Pre Operative Trastuzumab in Operable Breast Cancer","official_title":"A Phase III Double Blind Randomized Placebo Controlled Study of Trastuzumab as Short Duration Preoperative Therapy in Patients With HER2-neu Positive Operable Breast Cancer","primary_completion_date":"2025-04-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2027-02-28","last_update":"2020-10-08","description":"Background Information and Rationale: Trastuzumab is a humanized monoclonal antibody that acts extracellularly on the erbB-2 receptor.Trastuzumab is a recombinant humanized IgG1 monoclonal antibody against the human epidermal growth factor receptor 2 (HER2/erbB-2),which has shown in both in vitro assays and in animals, to inhibit the proliferation of human tumour cells that overexpress erbB-2. Additionally, trastuzumab is a potent mediator of antibody-dependent cell-mediated cytotoxicity (ADCC). In vitro, trastuzumab-mediated ADCC has been shown to be preferentially exerted on erbB-2 overexpressing cancer cells compared with cancer cells that do not overexpress erbB-2. Trastuzumab has emerged as a widely accepted standard of care for erbB-2-positive disease. (Metastatic/ adjuvant/neoadjuvant. Our current hypothesis suggests that the cells which are disseminated at the time of surgery will encounter an inhospitable environment which will be anti-HER in nature. Therefore combining the above mentioned streams of thought, we would like to assess the effect of a short pre-operative course of Trastuzumab on breast cancer relapse. The study is proposed in HER2 positive patients with operable breast cancer. Objectives : Primary: The primary objective of the study is to see the effect of short duration of peri-operative Trastuzumab on disease-free survival in comparison in all patients Secondary: The safety of the pre-operative therapies including the early post operative morbidity 1. Overall survival (OS) in all patients and in pathologically node positive patients. 2. The level of circulating tumor cells (CTCs) in the peripheral blood assessed before starting pre-operative therapy and at the same time point in the control arm, level of CTCs 10 minutes prior to start of surgery, during surgery and 10 days after surgery on 40 consecutive consenting patients (20 in each arm). The levels of circulating chromatin will also be estimated at the same time points as CTC for these 40 patients. 3. Evaluation of the paraffin blocks for pTEN loss6-8 and p95ErbB2 truncated form of HER2 on 100 consecutive consenting patients (50 in each arm).9-11 Study Design : This is phase 3, randomized Double blinded parallel group study of Trastuzumab in pre operative setting in operable breast cancer patients. Approximately 1000 patients with Women with HER2neu positive, T1/T2/T3 and N0/N1. clinical T4 and/or N2 disease who are considered operable by the treating surgeon with histopathological diagnosis on core biopsies, will be included in the study. Patients with T4 or N2 (locally advanced and large operable for neo-adjuvant chemotherapy) will not be included. All node positive patients will receive single injection of Depot Inj. Progesterone 500 mg deep IM 4 -14 days prior to surgery Patients will be stratified, before randomization for Tumor size, menopausal status, and affordability for Trastuzumab and centre of the study. These patients will then be randomized 1:1 to receive the following Intervention arm: .A single dose of Trastuzumab (Herceptin, Hoffman La Roche) at 8 mg/Kg as a 90 minute intravenous infusion in 250 ml of normal saline, in the window period of 10-15 4 to 14 days (both days inclusive) prior to the planned date of surgery. Control arm: A 90 minute intravenous infusion of saline as placebo All patients will thereafter receive standard post-operative adjuvant therapy as per local institutional practice including hormonal therapy, chemotherapy and radiation therapy.","other_id":"TMH Project-982","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:a.\r\n\r\n          1. Female subjects aged 18 years or older.\r\n\r\n          2. Histologically and/or cytologically confirmed diagnosis of breast cancer. Clinical\r\n             stages breast cancer: HER2 positive, T1 or T2 or T3, N0 or N1, resectable T4, or\r\n             resectable N2, (all M0)\r\n\r\n          3. Documentation of erbB-2 gene amplification by FISH (as defined by a ratio >2.2) or\r\n             chromogenic in situ hybridization (CISH, as defined by the manufacturer's kit\r\n             instruction) or documentation of erbB-2-overexpression by IHC (defined as IHC3+, or\r\n             IHC2+ with FISH or CISH confirmation) based on local laboratory.\r\n\r\n          4. LVEF within institutional range of normal as measured by MUGA or ECHO.\r\n\r\n          5. Screening laboratory values within the following parameters:\r\n\r\n               1. Absolute neutrophil count (ANC) 1.5 x 109 /L (1500/mm3)\r\n\r\n               2. Platelet count 100 x 109/L (100,000/mm3)\r\n\r\n               3. Hemoglobin 9.0 g/dL (90 g/L)\r\n\r\n               4. Serum creatinine 1.5 x upper limit of normal (ULN)\r\n\r\n               5. Total bilirubin 1.5 x ULN (<3 ULN if Gilbert's disease) 6Aspartate\r\n                  aminotransferase (AST) and/or alanine aminotransferase (ALT)\r\n\r\n                    -  2.5 x ULN\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Bilateral breast cancer\r\n\r\n          2. Active uncontrolled cardiac disease, including cardiomyopathy, CHF (New York Heart\r\n             Association [NYHA] functional classification of 3), unstable angina, and myocardial\r\n             infarction (within 12 months of study entry).\r\n\r\n          3. Inadequately controlled hypertension (ie, systolic blood pressure [BP] > 180 mm Hg or\r\n             diastolic BP > 100 mm Hg).\r\n\r\n          4. Family history of congenital long or short QT syndrome, Brugada syndrome or QT/QTc\r\n             interval > 0.45 second or known history of QT/QTc prolongation or torsade de pointe\r\n             (TdP).\r\n\r\n          5. Significant chronic gastrointestinal disorder with diarrhea as a major symptom (eg,\r\n             Crohn's disease, malabsorption, or grade 2 diarrhea of any etiology at baseline).\r\n\r\n          6. Women who are pregnant, breast-feeding.\r\n      ","sponsor":"Dr Rajendra A. Badwe","sponsor_type":"Other","conditions":"Carcinoma Breast Stage I|HER2 Positive Breast Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Trastuzumab","description":"A single dose of Trastuzumab (Herceptin, Hoffman La Roche) at 8 mg/Kg as a 90 minute infusion in 250 ml of normal saline, in the window period of 14 days (both days inclusive) prior to the planned date of surgery."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"A 90 minute intravenous infusion of saline as placebo"}],"outcomes":[{"outcome_type":"secondary","measure":"Overall survival","time_frame":"Up to 5 yrs","description":"4.1.1. Overall survival (OS) in all patients and in pathologically node positive patients."},{"outcome_type":"primary","measure":"Disease Free Survival","time_frame":"up to 5 yrs","description":"Survival follow-up visits (or information Collected via telephone call) will be conducted approximately every 6 months (ie, 24 weeks) starting from the last day of primary (adjuvant) treatment.\r\nThe subject will be called at clinic and will be carefully examined by a member of study team. A mammogram will be done every 18 months. If patient is symptomatic,additional investigations will be performed. Subject status as alive, alive with disease will be documented in the source file."},{"outcome_type":"secondary","measure":"Circulating Tumour Cells in Peripheral Blood","time_frame":"1. before starting pre-operative therapy and at the same time point in the control arm. 2. 10 minutes prior to start of surgery. 3. During surgery . 4. 10 days after surgery"},{"outcome_type":"secondary","measure":"4.1.3. Evaluation of the paraffin blocks for pTEN loss6-8 and p95ErbB2 truncated form of HER2","time_frame":"upto 5 yrs"}]}
{"nct_id":"NCT01802476","start_date":"2013-05-31","phase":"Phase 1","enrollment":14,"brief_title":"A Study Comparing the Plasma Drug Exposure of an Oral Dose of Palbociclib (PD-0332991) to an Intravenous Dose of Palbociclib (PD-0332991)","official_title":"A Phase 1, Single Dose, Fixed Sequence, 2-Period Cross-Over Absolute Oral Bioavailability Study In Healthy Volunteers Comparing Oral To Intravenous Administration Of PD-0332991","primary_completion_date":"2013-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-06-30","last_update":"2013-12-17","description":"The purpose of this study is to determine approximately what percentage of an orally administered dose of PD-0332991 is absorbed from the gastrointestinal tract into the systemic circulation. This approximation is made by comparing the plasma pharmacokinetics of a 125 mg oral dose of PD-0332991 to the plasma pharmacokinetics of a 50 mg intravenous dose of PD-0332991 administered as a 4-hour infusion.","other_id":"A5481015","intervention_model":"Crossover Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Healthy male or female of non-childbearing potential between the ages of 18 and 55\r\n             years of age.\r\n\r\n          2. A body mass index (BMI) between 17.5 and 30.5 kg/m2, and a total body weight greater\r\n             than 50kg (110 lbs)\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Any condition which could possibly affect drug absorption.\r\n\r\n          2. Pregnancy or actively nursing females, or females of childbearing potential.\r\n\r\n          3. A positive urine drug screen.\r\n      ","sponsor":"Pfizer","sponsor_type":"Industry","conditions":"Healthy","interventions":[{"intervention_type":"Drug","name":"Drug: Oral Drug Formulation of PD-0332991","description":"Treatment A consists of a single 125 mg oral dose of PD-0332991."},{"intervention_type":"Drug","name":"Drug: Intravenous Formulation of PD-0332991","description":"Treatment B consists of a 1000 mL intravenous infusion of 50 mg of PD-0332991 administered over 4 hours at a constant rate."}],"outcomes":[{"outcome_type":"primary","measure":"Dose-Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]","time_frame":"0 to 144 hours","description":"Dose-Normalized AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8) divided by the administered dose. It is obtained from AUC (0 - t) plus AUC (t - 8)."},{"outcome_type":"primary","measure":"Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]","time_frame":"0 to 144 hours","description":"AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8)."},{"outcome_type":"secondary","measure":"Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)","time_frame":"0 to 144 hours","description":"Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)"},{"outcome_type":"secondary","measure":"Dose-Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)","time_frame":"0 to 144 hours","description":"Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) divided by the administered dose."},{"outcome_type":"secondary","measure":"Maximum Observed Plasma Concentration (Cmax)","time_frame":"0 to 144 hours"},{"outcome_type":"secondary","measure":"Dose-Normalized Maximum Observed Plasma Concentration (Cmax)","time_frame":"0 to 144 hours","description":"The maximum observed plasma concentration divided by the administered dose."},{"outcome_type":"secondary","measure":"Time to Reach Maximum Observed Plasma Concentration (Tmax)","time_frame":"0 to 144 hours"},{"outcome_type":"secondary","measure":"Plasma Decay Half-Life (t1/2)","time_frame":"0 to 144 hours","description":"Plasma decay half-life is the time measured for the plasma concentration to decrease by one half."},{"outcome_type":"secondary","measure":"Systemic Clearance (CL)","time_frame":"0 to 144 hours","description":"CL is a quantitative measure of the rate at which a drug substance is removed from the body following an intravenous dose."},{"outcome_type":"secondary","measure":"Apparent Oral Clearance (CL/F)","time_frame":"0 to 144 hours","description":"Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood."},{"outcome_type":"secondary","measure":"Apparent Volume of Distribution after an Oral Dose (Vz/F)","time_frame":"0 to 144 hours"},{"outcome_type":"secondary","measure":"Volume of Distribution at Steady State after an IV Infusion (Vss)","time_frame":"0 to 144 hours"}]}
{"nct_id":"NCT02042482","start_date":"2013-05-31","phase":"Phase 2/Phase 3","enrollment":40,"brief_title":"The Effect of Combination Ultra Q10 and L-carnitine on the Course of Myelodysplastic Syndrome","official_title":"The Effect of the Nutritional Supplements: Ultra Q10 and L-carnitine on the Clinical Course of Myelodysplastic Syndrome","primary_completion_date":"2016-05-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2016-05-31","last_update":"2014-01-22","description":"The purpose of this study is determine whether combination Q10 , L-carnitine and multivitamin and mineral complex is effective in treatment of patients with low and intermidiate1-2 risk Myelodysplastic syndrome","other_id":"KMC01-35-12","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":90,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Patient willing and able complies with the protocol requirements. Patient given voluntary\r\n        written informed consent before performance of any study-related procedure that is not part\r\n        of standard medical care; with the understanding that the consent may be withdrawn by the\r\n        patient at any time without prejudice to their future medical care.\r\n\r\n        Patient is older than 18 years at the time of signing the informed consent. Patients older\r\n        than 80 years will sign informed consent after psycho-geriatric evaluation.\r\n\r\n        Patient diagnosed with Myelodysplastic syndrome, Low risk and intermediate-1risk according\r\n        to international prognostic scoring system with hemoglobin level less than 11g/l or\r\n        platelets less than 100000/ mcl or absolute neutrophils count less than 1000/mcl. With or\r\n        without fatigue syndrome.\r\n\r\n        INT-2 and high risk patients may be included into this trial when they are not eligible for\r\n        other treatment except Best Supportive Cure or failure to other conventional treatment\r\n        approach.\r\n\r\n        Bone marrow aspiration examination including cytogenetics performed up to 12 months before\r\n        inclusion and absence clinic-laboratory evidence of progressive disease in last month\r\n        Patient has a life-expectancy > 3 months\r\n\r\n        Exclusion Criteria:\r\n\r\n        Any serious medical conditions, including the presence of laboratory abnormalities, which\r\n        places the subject at an unacceptable risk if he or she participates in this study or\r\n        confounds the experimental ability to interpret data from the study.\r\n\r\n        Pregnant or lactating females. Prior history of malignancies, other than MDS, unless the\r\n        subject has been free of the disease for  3 years. Exceptions include the following: Basal\r\n        cell carcinoma of the skin, Squamous cell carcinoma of the skin, Carcinoma in situ of the\r\n        cervix, Carcinoma in situ of the breast, Incidental histological finding of prostate cancer\r\n        (TNM stage of T1a or T1b).\r\n\r\n        Bone marrow blast count >30%. Patient has known active infectious hepatitis B or C, or HIV\r\n        infection Administration of investigational drugs in the last 3 months. High risk MDS\r\n        patients and INT-2 patients who are candidates for cytoreductive or epigenetics treatment.\r\n\r\n        Any psychological, sociological condutions likely to affect compliance with the study\r\n        follow-up schedule.\r\n      ","sponsor":"Kaplan Medical Center","sponsor_type":"Other","conditions":"Myelodysplastic Syndrome","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Coenzyme Q10U, L-carnitine"}],"outcomes":[{"outcome_type":"primary","measure":"Change from baseline Hemoglobin, Platlets,White blood counts","time_frame":"12 weeks,24 weeks"},{"outcome_type":"secondary","measure":"Overall response rate","time_frame":"24 weeks"},{"outcome_type":"secondary","measure":"Progression free survival","time_frame":"24 weeks,52 weeks"},{"outcome_type":"secondary","measure":"Duration of response","time_frame":"24 weeks 52 weeks"},{"outcome_type":"secondary","measure":"Quality of life.","time_frame":"12 weeks 24 weeks 36weeks"}]}
{"nct_id":"NCT01858532","start_date":"2013-05-17","phase":"Phase 3","enrollment":5107,"brief_title":"Study Of Diabetic Nephropathy With Atrasentan","official_title":"A Randomized, Multicountry, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of Atrasentan on Renal Outcomes in Subjects With Type 2 Diabetes and Nephropathy. SONAR: Study Of Diabetic Nephropathy With Atrasentan","primary_completion_date":"2018-03-29","study_type":"Interventional","rec_status":"Terminated","completion_date":"2018-03-29","last_update":"2019-04-24","description":"The study objective was to evaluate the effect of atrasentan compared with placebo on time to doubling of serum creatinine (DBSC) or the onset of end-stage renal disease (ESRD) in participants with type 2 diabetes and nephropathy who were treated with the maximum tolerated labeled daily dose (MTLDD) of a renin-angiotensin system (RAS) inhibitor. In addition, the study assessed the effects of atrasentan compared with placebo on cardiovascular (CV) morbidity and mortality, urine albumin excretion, changes in estimated glomerular filtration rate (eGFR), as well as the impact on quality of life in participants with type 2 diabetes and nephropathy.","other_id":"M11-352","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Participant, or legal representative, had voluntarily signed and dated an Informed\r\n             Consent Form, approved by an Institutional Review Board (IRB)/Independent Ethics\r\n             Committee (IEC), after the nature of the study had been explained and the participant\r\n             had the opportunity to ask questions. The informed consent must have been signed\r\n             before any study-specific procedures were performed.\r\n\r\n          -  Participant had type 2 diabetes (including participants with latent autoimmune\r\n             diabetes or insulin-treated participants without a history of diabetic ketoacidosis\r\n             who also had a negative anti-glutamic acid decarboxylase test AND an elevated\r\n             post-prandial serum C-peptide level) and had been treated with at least one\r\n             anti-hyperglycemic medication and an angiotensin-converting enzyme inhibitor (ACEi) or\r\n             Angiotensin II receptor blocker (ARB; RAS inhibitor) for at least 4 weeks prior to the\r\n             Screening S2 visit.\r\n\r\n          -  For entry into the Run-In Period the participant must have satisfied the following\r\n             criteria based on the Screening laboratory values:\r\n\r\n               -  Estimated glomerular filtration rate (eGFR) 25 to 75 mL/min/1.73 m^2 [until the\r\n                  eGFR cap on participants (approximately 300) with a baseline of > 60 mL/min/1.73\r\n                  m^2 was reached] and a urine albumin creatinine ratio (UACR) greater than or\r\n                  equal to 300 and less than 5,000 mg/g (greater than or equal to 34 mg/mmol and\r\n                  less than 565 mg/mmol);\r\n\r\n               -  Serum albumin greater than or equal to 2.5 g/dL (25 g/L);\r\n\r\n               -  Brain natriuretic peptide (BNP) less than or equal to 200 pg/mL (200 ng/L);\r\n\r\n               -  Systolic blood pressure (SBP) greater than or equal to 110 and less than or equal\r\n                  to 180 mmHg;\r\n\r\n               -  Serum potassium greater than or equal to 3.5 mEq/L (3.5 mmol/L) and less than or\r\n                  equal to 6.0 mEq/L (6.0 mmol/L);\r\n\r\n               -  Participants on a maximum tolerated labeled daily dose (MTLDD) of a RAS inhibitor\r\n                  for greater than or equal to 4 weeks and on a diuretic at the time of screening\r\n                  and who satisfied the above criteria may have proceeded to the last visit in the\r\n                  Run-In Period (R6);\r\n\r\n               -  Participants already on a MTLDD of a RAS inhibitor for greater than or equal to 4\r\n                  weeks and not on a diuretic (unless medically contraindicated) at the time of\r\n                  Screening were to start with a diuretic and participate in Run-In for at least 2\r\n                  weeks.\r\n\r\n          -  For entry into the Enrichment Period the participant must have satisfied the following\r\n             criteria based on the last visit of the Run-In Period:\r\n\r\n               -  RAS inhibitor at the MTLDD for the previous 4 weeks with no adjustments of the\r\n                  dose;\r\n\r\n               -  Participants that were on a MTLDD RAS inhibitor and not on a diuretic (unless\r\n                  medically contraindicated) at the time of Screening must have been in Run-In for\r\n                  at least 2 weeks.\r\n\r\n          -  For entry into the Double-Blind Treatment Period, participants must have satisfied the\r\n             following criteria based on the last visit of the Enrichment Period:\r\n\r\n               -  RAS inhibitor at the MTLDD for the previous 6 weeks during the Enrichment Period\r\n                  with no adjustments of the dose;\r\n\r\n               -  Diuretic at any dose unless medically contraindicated or clinically intolerable\r\n                  in the investigator's judgement (i.e., hypotension or hypokalemia);\r\n\r\n               -  Participants must not have had a weight change greater than or equal to 3 kg from\r\n                  the beginning of Enrichment to the end of the Enrichment Period and absolute\r\n                  serum BNP greater than or equal to 300 pg/mL (300 ng/L) at the last Enrichment\r\n                  visit;\r\n\r\n               -  Participants must not have had an increase in serum creatinine greater than 0.5\r\n                  mg/dL and greater than 20% increase from the beginning of Enrichment to the end\r\n                  of the Enrichment Period.\r\n\r\n        Exclusion Criteria:\r\n\r\n        A participant was not eligible for entry into the Run-in Period if he/she met any of the\r\n        following criteria:\r\n\r\n          -  Participant had a history of severe peripheral edema or facial edema requiring\r\n             diuretics unrelated to trauma or a history of myxedema in the prior 4 weeks to the\r\n             initial Screening S1 visit.\r\n\r\n          -  Participant had a history of pulmonary hypertension, pulmonary fibrosis or any lung\r\n             diseases requiring oxygen therapy (e.g., chronic obstructive pulmonary disease,\r\n             emphysema).\r\n\r\n          -  Participant had a documented diagnosis of heart failure, previous hospitalization for\r\n             heart failure or current or constellation of symptoms (dyspnea on exertion, pedal\r\n             edema, orthopnea, paroxysmal nocturnal dyspnea) felt to be compatible with heart\r\n             failure, that was not explained by other causes, and for which there was a change in\r\n             medication or other management directed at heart failure.\r\n\r\n          -  Participant had known non-diabetic kidney disease (other than kidney stones).\r\n\r\n          -  Participant had elevated liver enzymes (serum alanine aminotransaminase [ALT] and/or\r\n             serum aspartate aminotransaminase [AST]) > 3  the upper limit of normal (ULN).\r\n\r\n          -  Participant had hemoglobin < 9 g/dL (90 g/L).\r\n\r\n          -  Participant had a sensitivity to loop diuretics.\r\n\r\n          -  Participant had a history of an allergic reaction or significant sensitivity to\r\n             atrasentan (or its excipients) or similar compounds.\r\n\r\n          -  Participant had a history of chronic gastrointestinal disease, which, in the\r\n             Investigator's opinion, may have caused significant GI malabsorption.\r\n\r\n          -  Participant had a history of secondary hypertension (i.e., hemodynamically significant\r\n             renal artery stenosis, primary aldosteronism or pheochromocytoma).\r\n\r\n          -  Participant had significant comorbidities (e.g., advanced malignancy, advanced liver\r\n             disease) with a life expectancy of less than 1 year.\r\n\r\n          -  Participant had clinically significant cerebrovascular disease (CVD) or coronary\r\n             artery disease (CAD) within 3 months prior to the Screening S1 visit, defined as one\r\n             of the following:\r\n\r\n               -  Hospitalization for MI or unstable angina; or\r\n\r\n               -  New onset angina with positive functional study or coronary angiogram revealing\r\n                  stenosis; or\r\n\r\n               -  Coronary revascularization procedure; or\r\n\r\n               -  Transient Ischemic Attack or Stroke.\r\n\r\n          -  Participant had received any investigational drug including atrasentan within 3 months\r\n             prior to the Screening S1 visit.\r\n\r\n          -  Participant received dialysis treatments or was expected to receive dialysis or renal\r\n             transplant within 6 months of screening.\r\n\r\n          -  Participant was currently receiving rosiglitazone, moxonidine, aldosterone blockers,\r\n             aliskiren or a combination of ACEi and ARB.\r\n\r\n          -  Participant was a premenopausal woman defined as (for study purposes) any female\r\n             subject with a menses in the past 2 years. For women who were < 50 years old, serum\r\n             FSH must have been greater than 35 IU/L. Women who were surgically sterile or had a\r\n             history of hysterectomy may not have necessarily be postmenopausal, and must also have\r\n             had an FSH > 35 IU/L.\r\n\r\n          -  Participant was at high risk for QT/QTc prolongation such as a family history of Long\r\n             QT Syndrome, defined as QTc prolongation exceeding 450 ms in men, or 460 ms in women.\r\n\r\n          -  Participant had type 1 diabetes.\r\n\r\n          -  Participant was considered to be clinically unstable regarding general, metabolic or\r\n             cardiovascular health as determined by the Investigator.\r\n      ","sponsor":"AbbVie","sponsor_type":"Industry","conditions":"Diabetic Nephropathy","interventions":[{"intervention_type":"Drug","name":"Drug: Atrasentan","description":"Film-coated tablet"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Film-coated tablet"}],"outcomes":[{"outcome_type":"primary","measure":"Time to the First Occurrence of a Component of the Composite Renal Endpoint in the Intent-to-Treat (ITT) Responder Set (as Randomized)","time_frame":"From randomization to individual end of observation, up to 53 months","description":"Time to the first occurrence of a component of the composite renal endpoint was defined as doubling of serum creatinine (confirmed by a 30-day serum creatinine measurement) or the onset of end stage renal disease (estimated glomerular filtration rate [eGFR] less than 15 ml/min/1.73 m^2 confirmed by a 90-day eGFR measurement, receiving chronic dialysis, renal transplantation, or renal death). Only events adjudicated by the Events Adjudication Committee (EAC) were considered in defining this endpoint. Data are presented as number of participants with a primary renal composite event (first event per participant)."},{"outcome_type":"secondary","measure":"Time to a 50% Estimated Glomerular Filtration Rate Reduction in the Intent-to-Treat (ITT) Responder Set (as Randomized)","time_frame":"From randomization to individual end of observation, up to 53 months","description":"The event of interest for this outcome was a 50% reduction in a participant's estimated glomerular filtration rate (eGFR) value as compared to baseline, confirmed by a repeated value at least 20 days apart. The event time was defined as the first time that a 50% reduction in eGFR was observed. Data are presented as number of participants with a 50% reduction in eGFR (first event per participant)."},{"outcome_type":"secondary","measure":"Time to Cardio-renal Composite Endpoint in the Intent-to-Treat (ITT) Responder Set (as Randomized)","time_frame":"From randomization to individual end of observation, up to 53 months","description":"The composite event of interest for this outcome consisted of doubling of serum creatinine, end-stage renal disease (ESRD), cardiovascular (CV) death (including CV death and presumed CV death), nonfatal myocardial infarction (MI; heart attack) and nonfatal stroke. Presumed sudden cardiac death was included as a subcategory of presumed CV death. Only events adjudicated by the Events Adjudication Committee (EAC) were considered in defining this endpoint. Data are presented as number of participants with a cardio-renal composite event (first event per participant)."},{"outcome_type":"secondary","measure":"Time to First Occurrence of a Component of Composite Renal Endpoint for All Randomized Participants (Pooled)","time_frame":"From randomization to individual end of observation, up to 53 months","description":"Time to the first occurrence of a component of the composite renal endpoint was defined as doubling of serum creatinine (confirmed by a 30-day serum creatinine measurement) or the onset of end stage renal disease (estimated glomerular filtration rate [eGFR] less than 15 ml/min/1.73 m^2 confirmed by a 90-day eGFR measurement, receiving chronic dialysis, renal transplantation, or renal death). Data for all randomized participants were pooled by treatment and analyzed. Data are presented as number of participants with a renal composite event (first event per participant)."},{"outcome_type":"secondary","measure":"Time to the Cardiovascular Composite Endpoint in the Intent-to-Treat (ITT) Responder Set (as Randomized)","time_frame":"From randomization to individual end of observation, up to 53 months","description":"The composite event of interest for this outcome was cardiovascular (CV) death (CV death, presumed CV death), nonfatal myocardial infarction (MI; heart attack), and nonfatal stroke. Presumed sudden cardiac death was included as a sub-category of presumed CV death. Only events adjudicated by the Events Adjudication Committee (EAC) were used. Data are presented as number of participants with a cardiovascular composite event (first event per participant)."}]}
{"nct_id":"NCT01678222","start_date":"2013-05-02","enrollment":117,"brief_title":"The COX-2 Gene and the Immune System","official_title":"The Role of Functionally Relevant Cyclooxygenase-2 (COX-2) Gene Single Nucleotide Polymorphisms -765G>C and 8473T>C in Lymphocyte Differentiation","study_type":"Observational","rec_status":"Completed","last_update":"2021-09-21","description":"Background: - The immune system contains several different types of cells in the blood and other parts of the body. The body can fight infections well with the right balance of these cell types. The wrong balance of cell types may cause diseases, such as allergies or asthma. The COX-2 gene may help decide the balance of cell types that the body makes as part of the immune system. It may also play a role in certain immune system diseases. Researchers want to see how COX-2 affects the cells in the immune system. Objectives: - To study how the COX-2 gene works in the body s immune system. Eligibility: - Individuals 18 years of age and above who are part of the Environmental Polymorphisms Registry. Design: - Participants will have one study visit at the National Institutes of Health. They will collect a urine sample at home on the morning of the study visit. - Participants will have a physical exam and medical history. They will provide a blood sample. They will also give researchers the urine sample they collected that morning. - No treatment will be provided as part of this study.","other_id":"120190","observational_model":"Cohort","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":150,"population":"individuals who are homozygous for either the major or minor variant of both SNPs@@@","criteria":"\n        -  INCLUSION CRITERIA:\r\n\r\n          -  Participant of the Environmental Polymorphisms Registry and current contact\r\n             information available\r\n\r\n          -  Genotype information available for relevant 765G>C and 8473T>C COX2 polymorphisms,\r\n             which indicates:\r\n\r\n               -  Individuals who are WT with respect to both 765G>C and 8473T>C (N=31)\r\n\r\n               -  Individuals who are WT with respect to 765G>C and homozygous for 8473T>C (N=31)\r\n\r\n               -  Individuals who are homozygous for both 765G>C and 8473T>C (N=31)\r\n\r\n          -  Age 18- 65 years\r\n\r\n          -  Race self-identified as White or Black and Non-Hispanic ethnicity\r\n\r\n          -  Willing and able to provide informed consent\r\n\r\n          -  Able to comply with all protocol procedures\r\n\r\n        EXCLUSION CRITERIA:\r\n\r\n          -  History of infection within the preceding 1 week or an oral temperature >38 degrees C\r\n\r\n          -  Current daily or chronic use of corticosteroids (systemic, inhaled and topical).\r\n\r\n          -  Any current conditions known to impact peripheral white blood cell count (e.g.,\r\n             leukemia, lymphopenia, AIDS, other immunodeficiency disorders)\r\n\r\n          -  Current daily or chronic use of systemic immunosuppressants.\r\n\r\n          -  Current pregnancy or lactation\r\n\r\n          -  Unwilling or unable to:\r\n\r\n               -  Fast (including alcohol and caffeine-containing products) and discontinue tobacco\r\n                  use for 12 hours prior to the study visit\r\n\r\n               -  Withhold all prescribed and over-the-counter medications and supplements the\r\n                  morning of the study visit, until after the visit is completed\r\n\r\n               -  Refrain from taking the following medications and supplements for 7 days prior to\r\n                  the study visit:\r\n\r\n                    -  NSAIDs\r\n\r\n                    -  Corticosteroids (nasal, inhaled, topical or systemic)\r\n\r\n                    -  Fish oil and niacin supplements\r\n\r\n          -  For blood draws that exceed 200ml, a hematocrit of <34% for women or <36% for men, or\r\n             >56% for either gender.\r\n\r\n          -  For blood draws exceeding 200ml, blood or plasma donation in the last 8 weeks\r\n      ","sponsor":"National Institute of Environmental Health Sciences (NIEHS)","sponsor_type":"NIH","conditions":"Asthma|Allergic Inflammation","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"To determine whether 765>C is associated with altered Th2, Th9, and Th17 differentiation in vivo","time_frame":"Ongoing","description":"To determine whether 765>C is associated with altered Th2, Th9, and Th17 differentiation in vivo"},{"outcome_type":"primary","measure":"To determine whether 8473T>C is associated with altered Th2, Th9, and Th17 differentiation in vivo","time_frame":"Ongoing","description":"To determine whether 8473T>C is associated with altered Th2, Th9, and Th17 differentiation in vivo"}]}
{"nct_id":"NCT01550224","start_date":"2013-05-01","phase":"Phase 2","enrollment":23,"brief_title":"Temozolomide Plus Vorinostat in Relapse/Refractory Acute Myeloid Leukemia (AML)","official_title":"Temozolomide Plus Vorinostat in Patients With Relapse/Refractory Acute Myeloid Leukemia (AML)","primary_completion_date":"2014-11-17","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-11-17","last_update":"2018-08-09","description":"The purpose of the study is to first determine if temozolomide plus vorinostat in combination can control relapsed or refractory acute myeloid leukemia (AML) and determine if this combination can be safely taken. The study will look at the side effects of the Temozolomide plus Vorinostat in combination and whether the treatment schedule is tolerated.","other_id":"IRB-22794","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        INCLUSION CRITERIA\r\n\r\n          -  Histologically- or cytologically-confirmed acute myeloid leukemia (AML)\r\n\r\n          -  Relapsed or refractory (AML), after at least 1 prior induction regimen\r\n\r\n          -  Age  18 years\r\n\r\n          -  Life expectancy > 2 months.\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) Performance Status  2\r\n\r\n          -  Calculated creatinine clearance  2.0 mg/dL (OR  30 mL/min for patients with serum\r\n             creatinine levels > 2.0 mg/dL)\r\n\r\n          -  Serum total bilirubin  1.5 X upper limit of normal (ULN)\r\n\r\n          -  Aspartate aminotransferase (AST)  2.5 X ULN\r\n\r\n          -  Alanine aminotransferase (ALT)  2.5 X ULN\r\n\r\n          -  Alkaline phosphatase (liver fraction)  2.5 X ULN\r\n\r\n          -  If male, must agree to use an adequate method of contraception for the duration of the\r\n             study and 1 month following coming off study or of study completion\r\n\r\n          -  If female of childbearing potential, must a negative serum pregnancy test within 72\r\n             hours prior to receiving the first dose of vorinostat.\r\n\r\n          -  If female, must be one of the following:\r\n\r\n               -  Post-menopausal (free from menses for  2 years),\r\n\r\n               -  Surgically-sterilized\r\n\r\n               -  Willing to use 2 adequate barrier methods of contraception\r\n\r\n               -  Agree to abstain from heterosexual activity throughout the study, starting with\r\n                  Visit 1\r\n\r\n          -  Available at the treating institution for study assessments and procedures for the\r\n             duration of the study\r\n\r\n          -  Written informed consent\r\n\r\n        EXCLUSION CRITERIA\r\n\r\n          -  Received chemotherapy; radiotherapy; or biological therapy within 30 days (42 days for\r\n             nitrosoureas or mitomycin C) prior to initial dosing with study drug(s), or has not\r\n             recovered from adverse events due to agents administered more than 30 days earlier,\r\n             except for hydroxyurea-related adverse events.\r\n\r\n          -  Currently participating or within 30 days of initial dosing with study drug(s), has\r\n             participated in a study with an investigational compound or device\r\n\r\n          -  Receiving any other investigational agents or concomitant radiotherapy, chemotherapy,\r\n             or immunotherapy.\r\n\r\n          -  Received a histone deacetylase (HDAC) inhibitor [eg, romidepsin (Depsipeptide),\r\n             NSC-630176, MS 275, LAQ-824, belinostat (PXD-101), LBH589, MGCD0103, CRA024781, etc]\r\n             within the past 30 days. Patients who have received valproic acid or other compounds\r\n             with HDAC inhibitor-like activity, as anti-tumor therapy should not enroll in this\r\n             study. Patients who have received such compounds for other indications, eg, valproic\r\n             acid for epilepsy, may enroll after a 30-day washout period.\r\n\r\n          -  History of allergic reactions attributed to compounds of similar chemical or biologic\r\n             composition to temozolomide; vorinostat; dacarbazine (DTIC-Dome, DIC, imidazole\r\n             carboxamide)\r\n\r\n          -  History of gastrointestinal disease or significant bowel resection that could\r\n             interfere with drug absorption or inability to swallow tablets.\r\n\r\n          -  Uncontrolled intercurrent illness (as defined by the investigators) including, but not\r\n             limited to, ongoing or active infection (HIV, Hepatitis B or Hepatitis C), symptomatic\r\n             congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric\r\n             illness/social situations that would limit compliance with study requirements.\r\n\r\n          -  Prior allogeneic stem cell transplantation within 2 months of trial enrollment or\r\n             prior radiation up to more than 25% of bone marrow.\r\n\r\n          -  Currently active 2nd malignancy, other than nonmelanoma skin cancer and carcinoma in\r\n             situ of the cervix (completed therapy for a prior malignancy, and disease-free from\r\n             prior malignancies for >5 years or are considered by their physician to be at less\r\n             than 30% risk of relapse is not considered to be an \"currently active\" malignancy)\r\n\r\n          -  Known psychiatric or substance abuse disorders that would interfere with cooperation\r\n             with the requirements of the trial\r\n\r\n          -  Pregnant or breast feeding\r\n\r\n          -  Expecting to conceive or father children within the projected duration of the study.\r\n\r\n          -  Uncontrolled intercurrent illness or circumstances that could limit compliance with\r\n             the study, including, but not limited to the following: active infection, acute or\r\n             chronic graft versus host disease, symptomatic congestive heart failure, unstable\r\n             angina pectoris, cardiac arrhythmia, or psychiatric conditions.\r\n\r\n          -  History or current evidence of any condition, therapy, or lab abnormality that might\r\n             confound the results of the study, interfere with the patient's participation for the\r\n             full duration of the study, or is not in the best interest of the patient to\r\n             participate.\r\n      ","sponsor":"Steven E. Coutre","sponsor_type":"Other","conditions":"Acute Myeloid Leukemia With 11q23-abnormality in Relapse","interventions":[{"intervention_type":"Drug","name":"Drug: Temozolomide","description":"An alkylating agent administered for induction per standard of care at 200 mg/m/day for 7days."},{"intervention_type":"Drug","name":"Drug: Vorinostat","description":"A synthetic hydroxamic acid derivative with antineoplastic activity administered for both groups at 500 mg orally 3 times daily for 3 days prior to Temozolomide 200 mg/m/day."}],"outcomes":[{"outcome_type":"primary","measure":"Complete Remission (CR)","time_frame":"up to 10 weeks","description":"This study evaluates the clinical efficacy of temozolomide + vorinostat as administered to Groups 1 and 2, assessed as the rate of complete remission [CR, aka morphologic complete remission (mCR)], defined as the morphologic leukemia-free state (MLFS), WITH absolute neutrophil count (ANC) ≥ 1,000/µL AND platelets (PLT) ≥ 100,000/µL. The outcome is reported as the percentage without dispersion of participants in Groups 1 and 2 that demonstrated CR. CR is defined as all of the following.\r\nMLFS = < 5% blasts in bone marrow aspirate containing marrow spicules > 200 nucleated cells no blasts with Auer rods no persistence of extramedullary disease ANC = ≥ 1,000/µL PLT = ≥ 100,000/µL"},{"outcome_type":"secondary","measure":"Morphologic Leukemia-free State (MLFS)","time_frame":"up to 10 weeks","description":"The rate of morphologic leukemia-free state (MLFS) is reported as the percentage without dispersion of participants in Groups 1 and 2 that achieve MLFS. The outcome is reported as the percentage without dispersion of participants in Groups 1 and 2 that demonstrated MLFS. This assessment is independent of absolute neutrophil count (ANC) or platelets (PLT) recovery status. MLFS is defined below.\r\nMLFS = < 5% blasts in bone marrow aspirate containing marrow spicules > 200 nucleated cells no blasts with Auer rods no persistence of extramedullary disease"},{"outcome_type":"secondary","measure":"Complete Remission With Incomplete Blood Count Recovery (CRp)","time_frame":"up to 10 weeks","description":"The rate of complete remission with incomplete blood count recovery (CRp) for Groups 1 and 2 was assessed as the rate of morphologic leukemia-free state (MLFS) but with EITHER residual neutropenia (ANC < 1,000/µL) OR residual thrombocytopenia (PLT < 100,000/µL). MLFS is defined as follows.\r\nMLFS = < 5% blasts in bone marrow aspirate containing marrow spicules > 200 nucleated cells no blasts with Auer rods no persistence of extramedullary disease"},{"outcome_type":"secondary","measure":"Cytogenetic Response (CyR)","time_frame":"up to 10 weeks","description":"Cytogenetic response (CyR) is defined as complete remission (CR), PLUS a documented decrease or absence of cytogenetic abnormalities, when analyzed microscopically for 20 cellular metaphases (actively dividing cells). The outcome is reported as the percentage without dispersion of participants in Groups 1 and 2 that demonstrated CyR. CR is defined as all of the following.\r\nCR = < 5% blasts in bone marrow aspirate containing marrow spicules; > 200 nucleated cells no blasts with Auer rods; no persistence of extramedullary disease absolute neutrophil count (ANC) ≥ 1,000/µL platelets (PLT) ≥ 100,000/µL"},{"outcome_type":"secondary","measure":"Partial Remission (PR)","time_frame":"up to 10 weeks","description":"Partial remission (PR) is reported as the percentage without dispersion of participants in Groups 1 and 2 that demonstrated PR. PR is defined as all of the following.\r\nPR = 5% to 25% blasts (must be ≥ 50% reduction of blasts) in bone marrow aspirate containing marrow spicules; > 200 nucleated cells no blasts with Auer rods no persistence of extramedullary disease absolute neutrophil count (ANC) ≥ 1,000/µL platelets (PLT) ≥ 100,000/µL"},{"outcome_type":"secondary","measure":"Treatment Failure (TF)","time_frame":"up to 10 weeks","description":"Treatment failure (TF) is defined as failing to achieve either a complete remission (CR) or partial remission (PR) after induction chemotherapy. The outcome is reported as the percentage without dispersion of participants in Groups 1 and 2 that experienced TF. CR and PR are defined as the following.\r\nCR = < 5% blasts in bone marrow aspirate containing marrow spicules; > 200 nucleated cells no blasts with Auer rods; no persistence of extramedullary disease absolute neutrophil count (ANC) ≥ 1,000/µL platelets (PLT) ≥ 100,000/µL\r\nPR = 5% to 25% blasts (must be ≥ 50% reduction of blasts) in bone marrow aspirate containing marrow spicules; > 200 nucleated cells no blasts with Auer rods no persistence of extramedullary disease absolute neutrophil count (ANC) ≥ 1,000/µL platelets (PLT) ≥ 100,000/µL"},{"outcome_type":"secondary","measure":"Disease-free Survival (DFS) at 2 Years","time_frame":"2 years","description":"Disease-Free Survival (DFS) is defined as survival after complete response (CR) without disease progression. DFS is reported as the percentage without dispersion of participants in Groups 1 and 2 that experienced CR and were alive without progression (ie, without disease) 2 years after induction chemotherapy. CR is defined as all of the following.\r\nCR = < 5% blasts in bone marrow aspirate containing marrow spicules; > 200 nucleated cells no blasts with Auer rods; no persistence of extramedullary disease absolute neutrophil count (ANC) ≥ 1,000/µL platelets (PLT) ≥ 100,000/µL"},{"outcome_type":"secondary","measure":"Relapse-Free Survival (RFS) at 2 Years","time_frame":"2 years","description":"Relapse-free survival (RFS) is defined as survival after complete response (CR) or (PR) without further disease progression. RFS is reported as the percentage without dispersion of participants in Groups 1 and 2 that experienced CR or PR, and were alive without progression 2 years after induction chemotherapy. CR and PR are defined as the following.\r\nCR = < 5% blasts in bone marrow aspirate containing marrow spicules; > 200 nucleated cells no blasts with Auer rods; no persistence of extramedullary disease absolute neutrophil count (ANC) ≥ 1,000/µL platelets (PLT) ≥ 100,000/µL\r\nPR = 5% to 25% blasts (must be ≥ 50% reduction of blasts) in bone marrow aspirate containing marrow spicules; > 200 nucleated cells no blasts with Auer rods no persistence of extramedullary disease absolute neutrophil count (ANC) ≥ 1,000/µL platelets (PLT) ≥ 100,000/µL"},{"outcome_type":"secondary","measure":"Overall Survival (OS) at 2 Years","time_frame":"2 years","description":"Overall Survival (OS) is defined as survival regardless of clinical status. OS is reported as the percentage without dispersion of participants in Groups 1 and 2 that remained alive 2 years after induction chemotherapy."}]}
{"nct_id":"NCT01837706","start_date":"2013-04-30","enrollment":437,"brief_title":"The Impact of Emergency Physician Empathy on Litigation Propensity","official_title":"The Impact of Emergency Physician Empathy on Litigation Propensity","primary_completion_date":"2013-06-30","study_type":"Observational","rec_status":"Completed","completion_date":"2013-12-31","last_update":"2014-10-03","description":"The purpose of this study is to observe whether people would report being less likely to sue a physician who shows more empathy when giving a patient potentially bad news regarding their medical condition.","other_id":"RS-5120206","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"Emergency room patients","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Emergency Room Patient\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Non-English speaking\r\n\r\n          -  Not healthy enough to be in waiting room\r\n      ","sponsor":"Loma Linda University","sponsor_type":"Other","conditions":"Empathy","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Intention to sue","time_frame":"Immediately after viewing","description":"This outcome will be assessed by asking \"Would you sue this doctor?\" after viewing a short video. Items will be measured on a 5-point scale (1=Definitely no to 5=Definitely yes)."},{"outcome_type":"secondary","measure":"Assessment of physician expertise","time_frame":"Immediately after viewing","description":"This outcome will be assessed by asking \"Do you believe this physician is an expert?\" after viewing a short video. Items will be measured on a 5-point scale (1=Definitely no to 5=Definitely yes)."},{"outcome_type":"secondary","measure":"Assessment of physician caring","time_frame":"Immediately after viewing","description":"This outcome will be assessed by asking \"Do you think this doctor cared about the patient?\" after viewing a short video. Items will be measured on a 5-point scale (1=Definitely no to 5=Definitely yes)."},{"outcome_type":"secondary","measure":"Assessment of whether subject would want to be physician's patient","time_frame":"Immediately after viewing","description":"This outcome will be assessed by asking \"Would you want this physician as your doctor?\" after viewing a short video. Items will be measured on a 5-point scale (1=Definitely no to 5=Definitely yes)."},{"outcome_type":"secondary","measure":"Assessment of clarity of physician instructions","time_frame":"Immediatley after viewing","description":"This outcome will be assessed by asking \"Did you understand the instructions the doctor gave the patient?\" after viewing a short video. Items will be measured on a 5-point scale (1=Definitely no to 5=Definitely yes)."}]}
{"nct_id":"NCT01461252","start_date":"2013-04-30","phase":"Phase 1","enrollment":0,"brief_title":"Safety and Efficacy of Cryoablation Combined With Radiation Therapy for the Palliation of Painful Bone Metastases","official_title":"Cryoablation Combined With Radiation Therapy for the Palliation of Painful Bone Metastases","primary_completion_date":"2014-03-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2014-03-31","last_update":"2021-07-16","description":"This study will evaluate the safety and efficacy of cryoablation therapy combined with radiation therapy for the relief of pain associated with metastatic bone tumors.","other_id":"CUC10-BNE01","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18 years of age or older\r\n\r\n          -  Metastatic bone disease with metastatic disease previously confirmed by prior biopsy;\r\n             or Metastatic bone disease previously confirmed on imaging [e.g. computed tomography\r\n             (CT) or magnetic resonance imaging (MRI)] with known (biopsied) primary disease\r\n             (primary bone cancer is excluded)\r\n\r\n          -  Current analgesic therapies have failed OR the subject is experiencing intolerable\r\n             side effects\r\n\r\n          -  Unremitting pain that resulted in a return visit to the oncologist. The 'worst pain'\r\n             in the last 24 hours must be reported to be 4 or above on a scale of 0 (no pain) to 10\r\n             (pain as bad as subject can imagine) despite pharmaceutical pain management\r\n\r\n          -  Pain must be from one or two painful metastatic sites in the bone that is amenable to\r\n             cryoablation with CT or MRI (additional less painful metastatic sites may be present)\r\n\r\n              Pain from the reported one or two metastatic sites must correlate with an\r\n             identifiable tumor on CT, MRI, or ultrasound (US) imaging\r\n\r\n          -  Tumors must be suitable for cryoablation\r\n\r\n          -  If the primary tumor is in the spine, there must be an intact cortex between the mass\r\n             and the spinal canal and exiting nerve roots\r\n\r\n          -  Cryoablation should be performed within 14 days of baseline evaluations\r\n\r\n          -  Stable use of hormonal therapy (no changes within 4 weeks prior to the cryoablation\r\n             procedure)\r\n\r\n          -  Stable use of pain medications (no changes within 2 weeks prior to the cryoablation\r\n             procedure)\r\n\r\n          -  ECOG (Eastern Cooperative Oncology Group) scale performance status 0-3\r\n\r\n          -  Life expectancy  2 months\r\n\r\n          -  Platelet count >50,000/mm within 6 weeks of screening\r\n\r\n          -  INR (International Normalized Ratio) <1.5 within 6 weeks of screening\r\n\r\n          -  No debilitating medical or psychiatric illness that would preclude giving informed\r\n             consent or receiving optimal treatment and follow-up\r\n\r\n          -  If taking antiplatelet or anticoagulation medication, it must be able to be\r\n             discontinued prior to the procedure for an appropriate amount of time (e.g., aspirin,\r\n             ibuprofen, low molecular weight heparin preparations)\r\n\r\n          -  Clinically suitable for cryoablation therapy\r\n\r\n          -  Clinically suitable for radiation therapy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Leukemia, lymphoma, and myeloma\r\n\r\n          -  Tumor involves a weight-bearing long bone of the lower extremity with the tumor\r\n             causing > 50% loss of cortical bone\r\n\r\n          -  Has undergone prior ablation treatment of the index tumor\r\n\r\n          -  Has undergone prior radiation therapy of the index tumor < 3 weeks prior to screening\r\n\r\n          -  Index tumor causing clinical or radiographic evidence of spinal cord or cauda equina\r\n             compression/effacement\r\n\r\n          -  Anticipated treatment of the index tumor that would require iceball formation within\r\n             1.0 cm of the spinal cord, brain, other critical nerve structure, large abdominal\r\n             vessel such as the aorta or inferior vena cava, bowel, or bladder\r\n\r\n          -  Surgery at the tumor site or surgery involving the cryoablation-treated tumor\r\n\r\n          -  Index tumor involves the skull (treatment of other painful tumors in subjects with\r\n             skull tumors is not excluded)\r\n\r\n          -  ANC (absolute neutrophil count) <1000 mm3 within 6 weeks of screening\r\n\r\n          -  Uncontrolled coagulopathy or bleeding disorders\r\n\r\n          -  Currently pregnant, nursing, or wishing to become pregnant during the study\r\n\r\n          -  Active, uncontrolled infection\r\n\r\n          -  Serious medical illness, including any of the following: uncontrolled congestive heart\r\n             failure, uncontrolled angina, myocardial infarction, cerebrovascular event within 6\r\n             months prior to study entry\r\n\r\n          -  Concurrent participation in other experimental studies that could affect the primary\r\n             endpoint\r\n      ","sponsor":"Boston Scientific Corporation","sponsor_type":"Industry","conditions":"Pain|Neoplasm Metastasis","interventions":[{"intervention_type":"Procedure","name":"Procedure: Cryoablation","description":"For cryoablation in the palliation of painful bone metastases, subject preparation, anesthesia, intra-operative monitoring, and postoperative management are identical to those of standard cryoablation routinely performed at all clinical centers participating in this study and are at the discretion of the investigator."},{"intervention_type":"Procedure","name":"Procedure: Radiation","description":"Radiation therapy is usually performed with 6-18 Megavolt photons from a linear accelerator. The proposed dose and frequency of radiation for this protocol are: 8 Gray in 1 fraction, 30 Gray in 10 fractions, or 37.5 Gray in 15 fractions. These proposed doses or other doses will be prescribed at the discretion of the investigator. It is anticipated that subjects will begin the radiation therapy approximately within one to three weeks after the cryoablation procedure. The doses and frequency of the radiation treatment will be collected as well as toxicities."}],"outcomes":[{"outcome_type":"primary","measure":"Difference in worst pain scores","time_frame":"24 weeks post cryoablation","description":"The endpoint for this study will be measured as follows: assessment of the effectiveness of cryoablation combined with radiation associated with palliation of pain in subjects with metastatic bone cancer by measuring the average difference of pre- and posttreatment worst pain in 24 hours from baseline to 24 hour, 1, 4, 12, and 24 week follow-up intervals as measured on the numeric 0 to 10 Brief Pain Inventory (BPI) scale."},{"outcome_type":"secondary","measure":"Cryoablation retreatments","time_frame":"24 weeks post-cryoablation","description":"If the first cryoablation procedure effectively relieves pain but the relief wears off over time and the pain becomes unbearable, a second procedure may be performed. The number of repeat cryoablation treatments will be recorded."},{"outcome_type":"secondary","measure":"Additional surgical treatments other than cryoablation","time_frame":"24 weeks post-cryoablation","description":"If pain is not effectively relieved by the cryoablation, other surgical treatments may be performed. The number of these treatments will be recorded."},{"outcome_type":"secondary","measure":"Reduced analgesic usage","time_frame":"24 weeks post-cryoablation","description":"The number of subjects (percentage) who are able to reduce analgesic medications from baseline to 24 hours, 1, 4, 12, and 24 weeks after cryoablation will be recorded."},{"outcome_type":"secondary","measure":"Time to maximal palliation of pain after cryoablation","time_frame":"24 weeks post-cryoablation","description":"The difference in pain scores will be assessed from baseline to follow-up intervals after cryoablation will be analyzed. The interval indicating the most relief from pain will be compared across subjects."},{"outcome_type":"secondary","measure":"Number of adverse events","time_frame":"30 days post-cryoablation","description":"The safety endpoint for this study is to assess the incidence and severity of intra-operative events, post operative adverse events, serious adverse events and unanticipated adverse device effects related to the cryoablation procedure."},{"outcome_type":"secondary","measure":"Difference in average pain scores","time_frame":"24 weeks post-cryoablation","description":"Difference in average pain scores from baseline to 24 hours, 1, 4, 12, and 24 weeks after cryoablation as measured on the numeric 0 to 10 BPI scale"},{"outcome_type":"secondary","measure":"Time to recurrence of worst pain","time_frame":"24 weeks post-cryoablation","description":"Time to recurrence of worst pain at or above baseline; worst pain score in the 24 week follow-up period as measured on the numeric 0 to 10 BPI scale"},{"outcome_type":"secondary","measure":"Subject satisfaction with the amount of palliation of pain obtained from cryoablation combined with radiation","time_frame":"24 weeks post-cryoablation","description":"Subject satisfaction will be compared at baseline to follow-up intervals."}]}
{"nct_id":"NCT01673828","start_date":"2013-04-30","phase":"Phase 2","enrollment":13,"brief_title":"Allopregnanolone for the Treatment of Traumatic Brain Injury","official_title":"A Double-blind, Placebo-controlled, Randomized Clinical Trial of Allopregnanolone for the Treatment of Traumatic Brain Injury","primary_completion_date":"2015-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-07-31","last_update":"2017-06-28","description":"This study will provide initial data on the safety and effectiveness of allopregnanolone in improving neurobehavioral outcome and reducing mortality in adults with moderate and severe traumatic brain injury.","other_id":"273147","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":16,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  English or Spanish speaking person\r\n\r\n          -  Moderate to severe closed or blunt traumatic brain injury [post resuscitation Glasgow\r\n             Coma Score (GCS) 3-12 with abnormal head CT scan if GCS is 9-12]\r\n\r\n          -  Less than 8 hours from injury to study initiation\r\n\r\n          -  Able to participate for the full term of the study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subjects with life expectancy of less than 24 hours\r\n\r\n          -  Isolated epidural hematoma\r\n\r\n          -  Hypoxia (pulse oximetry saturation 90% for 15 or more minutes before enrollment)\r\n\r\n          -  Hypotension (systolic blood pressure 90 mm Hg on 2 or more reliable measurements\r\n             before enrollment)\r\n\r\n          -  Cardiopulmonary arrest prior to randomization\r\n\r\n          -  Spinal cord injury with motor deficits\r\n\r\n          -  Bilateral non-reactive pupils with Glasgow Coma Scale 3\r\n\r\n          -  Body weight >120 kg\r\n\r\n          -  Pregnancy\r\n\r\n          -  Active breast or reproductive organ cancer\r\n\r\n          -  Allergy to progesterone\r\n\r\n          -  History of thromboembolic events\r\n\r\n          -  Receipt of activated Factor VII before enrollment\r\n\r\n          -  Any disease that is unstable or which could jeopardize the safety of the subject\r\n             including severe renal impairment (creatinine clearance <50 ml/min)\r\n\r\n          -  Prisoner/ward of the state\r\n\r\n          -  Known treatment with another investigational drug therapy or procedure within 30 days\r\n             of injury\r\n      ","sponsor":"Michael A. Rogawski, MD, PhD","sponsor_type":"Other","conditions":"Traumatic Brain Injury|Posttraumatic Epilepsy","interventions":[{"intervention_type":"Drug","name":"Drug: Allopregnanolone injection","description":"Allopregnanolone intravenous solution in 0.9% sodium chloride injection with 6% sulfobutyl ether -cyclodextrin sodium"},{"intervention_type":"Drug","name":"Drug: Placebo injection","description":"Placebo intravenous solution, 0.9% sodium chloride injection with 6% sulfobutyl ether -cyclodextrin sodium"}],"outcomes":[{"outcome_type":"primary","measure":"Extended Glasgow Outcome Scale (GOS-E) Score","time_frame":"6 months after injury","description":"GOS-E is a global scale for functional outcome that rates patient status into one of 8 levels. The minimum score is 1 and the maximum score is 8. 1 = dead; 2 = vegetative state; 3 = low severe disability; 4 = upper severe disability; 5 = low moderate disability; 6 = upper moderate disability; 7 = low good recovery; 8 = upper good recovery. GOS-E was assessed by 19 question structured interview."}]}
{"nct_id":"NCT01837160","start_date":"2013-04-30","enrollment":21,"brief_title":"Angiogenesis and Fibrosis in Aortic Stenosis","official_title":"The Identification of In Vivo Angiogenesis and Fibrosis in Aortic Stenosis Using Positron Emission Tomography","primary_completion_date":"2015-08-31","study_type":"Observational","rec_status":"Completed","completion_date":"2015-08-31","last_update":"2016-08-30","description":"Angiogenesis and fibrosis lie at the heart of a number of fundamental processes responsible for cardiovascular disease. In this proposal, the investigators intend to build upon a highly successful programme of studies exploring the cardiovascular applications of positron emission tomography. Specifically, the investigators will explore the potential role of a novel radiotracer, 18F-fluciclatide, which is a highly selective ligand for the v3 and v5 integrin receptors that are up regulated during angiogenesis, and tissue fibrosis and remodelling. This tracer has been successfully used to assess angiogenesis in metastatic tumours and its uptake is suppressed by anti-angiogenic therapies. The investigators here propose to describe the pattern of uptake of 18F-fluciclatide in cardiovascular diseases, specifically aortic stenosis and aortic atherosclerosis. The investigators will correlate 18F-fluciclatide uptake with in vivo measures of angiogenesis and fibrosis as well as ex vivo histological characterisation of tissue. If successful, this novel radiotracer could provide an extremely important non-invasive method of assessing in vivo angiogenesis, plaque vulnerability, and tissue remodelling as well as potential applications in developing stem cell therapies.","other_id":"2012/R/CAR/23","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":40,"population":"50 patients in total, recruited from Cardiology Outpatient Clinics","criteria":"\n        Inclusion Criteria\r\n\r\n          -  asymptomatic mild (peak valve velocity of 2-5-3.0 m/s; n=10), moderate (peak valve\r\n             velocity of 3.0-4.0 m/s; n=10) or severe aortic stenosis (peak valve velocity of >4.0\r\n             m/s; n=10) and 10 patients with severe aortic stenosis proceeding to aortic valve\r\n             replacement.\r\n\r\n          -  Healthy control subjects (n=10) will have no past medical history of ischaemic heart\r\n             disease or valvular heart disease and have a structurally normal heart on\r\n             echocardiography.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Atrial fibrillation\r\n\r\n          -  Hepatic failure (Childs-Pugh grade B or C)\r\n\r\n          -  Renal failure (estimated glomerular filtration rate <25 mL/min)\r\n\r\n          -  Women of child-bearing potential\r\n\r\n          -  Contraindication to magnetic resonance imaging\r\n\r\n          -  Inability to undergo scanning\r\n\r\n          -  Ochronosis and those with any form of collagen-vascular disease.\r\n      ","sponsor":"University of Edinburgh","sponsor_type":"Other","conditions":"Aortic Stenosis|Fibrosis|Neovascularization, Pathologic","interventions":[{"intervention_type":"Procedure","name":"Procedure: Cardiac MRI scan","description":"Cardiac MRI scan with assessment of late gadolinium enhancement and T1 mapping."},{"intervention_type":"Radiation","name":"Radiation: CT-PET scan","description":"Computed Tomography / Positron Emission Tomography scan with 18F-fluciclatide tracer."},{"intervention_type":"Procedure","name":"Procedure: Echocardiogram","description":"Echocardiography."},{"intervention_type":"Radiation","name":"Radiation: CT-coronary angiogram scan","description":"CT-coronary angiogram following CT-PET scan. Standard protocol."},{"intervention_type":"Procedure","name":"Procedure: Aortic Valve Replacement","description":"For AVR (already scheduled prior to enrollment)"}],"outcomes":[{"outcome_type":"primary","measure":"The mean and maximum standardised uptake values (SUV) of fluciclatide for the myocardium and its correlation with the severity of aortic stenosis determined echocardiographically.","time_frame":"1 - 2 years"},{"outcome_type":"primary","measure":"The mean and maximum standardised uptake values (SUV) of fluciclatide for the myocardium and its correlation with the volume of myocardial fibrosis on magnetic resonance scanning.","time_frame":"1 - 2 years"},{"outcome_type":"secondary","measure":"The mean and maximum standardised uptake values (SUV) of fluciclatide in the aortic valve in patients with aortic stenosis","time_frame":"1 year"},{"outcome_type":"secondary","measure":"The mean and maximum standardised uptake values (SUV) of fluciclatide in concomitant aortic atheroma","time_frame":"1 year"}]}
{"nct_id":"NCT01834677","start_date":"2013-04-30","enrollment":76,"brief_title":"Translational Research Evaluating Neurocognitive Memory Processes","official_title":"Translational Research Evaluating Neurocognitive Memory Processes","primary_completion_date":"2015-11-30","study_type":"Observational","rec_status":"Completed","completion_date":"2015-11-30","last_update":"2015-12-03","description":"The purpose of this study is to evaluate the psychometric properties and utility of new, computerized, neurocognitive measures in humans with depression, and humans with depression undergoing electroconvulsive therapy (ECT). The benefits of the study outweigh the risk as there is the possibility of developing better computerized neurocognitive measures, and the risks are limited to no more than minimal test related fatigue and psychological stress. Depressed humans, depressed human participants undergoing ECT, and humans diagnosed with Parkinson's disease (age 18-85) will be invited to participate in this study. After providing informed consent participants will undergo a clinical psychiatric evaluation to confirm the inclusion/exclusion criteria. After the clinical psychiatric evaluation, participants will complete common and new neurocognitive measures. There will be a total of two testing visits (baseline, 1-month follow-up). The anticipated duration of the participant's involvement is no more than 2 study visits that can take place over a 4-day period (i.e., the clinical evaluation can occur on day 1 and the neuropsychological measures can be administered on day 2 of each study visit) equating to approximately 6-hours (3-hours each day) per study visit.","other_id":"Pro00039288","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":85,"population":"Subjects are able to contact the study team. The depressed ECT cohort will be referred to\r\n        study team.","criteria":"\n        Inclusion Criteria:Depressed Individuals\r\n\r\n          1. Male and female subjects, age 18-85\r\n\r\n          2. DSM-IV-TR diagnosis of major depressive episode, unipolar, confirmed by the MINI-PLUS\r\n             [221]\r\n\r\n          3. HRSD24 total score > 10\r\n\r\n          4. MMSE total score > 26\r\n\r\n          5. Graduated from high school\r\n\r\n          6. Competent to provide informed consent\r\n\r\n        Inclusion Criteria:Depressed Individuals Receiving ECT\r\n\r\n          1. Same as for Depressed Cohort Inclusion Criteria (see above)\r\n\r\n          2. Referred for ECT\r\n\r\n          3. Subject competent to provide informed consent\r\n\r\n        Inclusion Criteria:Individuals Diagnosed with PD\r\n\r\n          1. Male and female subjects, age 18-85\r\n\r\n          2. Diagnosed with PD\r\n\r\n          3. MMSE total score > 20\r\n\r\n          4. Graduate high school\r\n\r\n          5. Subject competent to provide informed consent\r\n\r\n        Exclusion Criteria:Depressed Individuals/Depressed Individuals Receiving ECT\r\n\r\n          1. Lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder, or\r\n             mental retardation\r\n\r\n          2. Current neurostimulation treatment (e.g., ECT, MST, rTMS, vagus nerve stimulation,\r\n             deep brain stimulation)\r\n\r\n          3. Current alcohol abuse or dependence within past 12 months\r\n\r\n          4. Current substance abuse or dependence within past 12 months\r\n\r\n          5. Lifetime mental retardation\r\n\r\n          6. History of central nervous system (CNS) disease\r\n\r\n          7. Current diagnosis of dementia or delirium\r\n\r\n          8. Current visual, auditory, or motor impairment that compromises ability to take tests\r\n\r\n          9. Unable to read or comprehend English\r\n\r\n        Exclusion Criteria:Individuals Diagnosed with PD\r\n\r\n          1. Lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder, or\r\n             mental retardation\r\n\r\n          2. Current neurostimulation treatment (e.g., ECT, MST, rTMS, vagus nerve stimulation,\r\n             deep brain stimulation)\r\n\r\n          3. Current alcohol abuse or dependence within past 12 months\r\n\r\n          4. Current substance abuse or dependence within past 12 months\r\n\r\n          5. Lifetime mental retardation\r\n\r\n          6. History of central nervous system (CNS) disease other than Parkinson's Disease\r\n\r\n          7. Current diagnosis of dementia or delirium\r\n\r\n          8. Current visual, auditory, or motor impairment that compromises ability to take tests\r\n\r\n          9. Unable to read or comprehend English\r\n      ","sponsor":"Duke University","sponsor_type":"Other","conditions":"Neurocognition","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"California Verbal Learning Test-II","time_frame":"Baseline","description":"The California Verbal Learning Test-II (CVLT-II) is a standard neuropsychological instrument that assesses verbal learning and memory."},{"outcome_type":"primary","measure":"California Verbal Learning Test-II","time_frame":"1-Month Follow-up","description":"The California Verbal Learning Test-II (CVLT-II) is a standard neuropsychological instrument that assesses verbal learning and memory."}]}
{"nct_id":"NCT01849562","start_date":"2013-04-30","phase":"Phase 2","enrollment":30,"brief_title":"Safety, Tolerability and Efficacy of 12-weeks of Sovaprevir, ACH-3102 and Ribavirin in Treatment-naive GT-1 HCV Subjects","official_title":"A Phase 2a Trial to Evaluate the Safety, Tolerability and Efficacy of 12 Weeks of Sovaprevir, ACH-0143102 and Ribavirin in Treatment-Naive Subjects With Chronic Hepatitis C Genotype-1 Viral Infection","primary_completion_date":"2013-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-04-30","last_update":"2015-09-17","description":"The purpose of this study is to evaluate the safety, tolerability and efficacy of 12 weeks of treatment with sovaprevir, ACH-0143102 and ribavirin in GT1, treatment-naive, HCV subjects.","other_id":"ACH102-007","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Males and Females between ages 18 and 65\r\n\r\n          -  Chronic HCV infection\r\n\r\n          -  HCV genotype 1\r\n\r\n          -  HCV RNA > 10,000 IU/mL at screening.\r\n\r\n          -  Female patients must be willing to use two effective methods of contraception, one of\r\n             which must be barrier method, during dosing period and six months after last dose of\r\n             ribavirin. Females of childbearing potential must have a negative pregnancy test at\r\n             screening and baseline.\r\n\r\n          -  Male patients must be willing to use an effective barrier method of contraception\r\n             throughout the dosing period and for six months.\r\n\r\n          -  Signed and dated written informed consent form.\r\n\r\n          -  Willing to participate in all study activities and all study requirements (including\r\n             effective contraception) during study period.\r\n\r\n          -  Treatment nave subjects defined as subjects who have never received pegylated\r\n             interferon, RBV, or a direct-acting anti-viral agent for the treatment of chronic HCV\r\n             infection.\r\n\r\n          -  A liver biopsy within the last 3 years without evidence of cirrhosis.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Body Mass Index (BMI) > 36.0\r\n\r\n          -  Pregnant or nursing (lactating) females, confirmed by a positive human chorionic\r\n             gonadotropin (HCG) laboratory test or females contemplating pregnancy\r\n\r\n          -  Participation in any interventional clinical trial within 35 days prior to first study\r\n             medication dose administration on Day 1\r\n\r\n          -  Known HIV-1 or HIV-2 infection/serology and/or positive Hepatitis B Surface Antigen\r\n             (HBsAg)\r\n\r\n          -  Use of dietary supplements, grapefruit juice, herbal supplements, CYP2C8 substrates,\r\n             CYP3A4 inducers and inhibitors, PGP inducers and substrates, OATP inhibitors and\r\n             substrates, and potent inducers of other CYP enzymes within 14 days prior to dosing\r\n             through 7 days following completion of study meds.\r\n\r\n          -  Clinically significant laboratory abnormality at screening (specified in protocol)\r\n\r\n          -  Other forms of liver disease\r\n\r\n          -  History of severe or uncontrolled psychiatric disease\r\n\r\n          -  History of malignancy of any organ system, treated or untreated within the past 5\r\n             years\r\n\r\n          -  History of major organ transplantation\r\n\r\n          -  Use of bone marrow colony stimulating factor agents within 3 months prior to baseline.\r\n\r\n          -  History of seizure disorder requiring ongoing medical therapy\r\n\r\n          -  History of known coagulopathy including hemophilia\r\n\r\n          -  History of hemoglobinopathy, including sickle cell anemia and thalassemia.\r\n\r\n          -  History of immunologically mediated disease (specified in protocol)\r\n\r\n          -  History of clinical evidence of significant chronic cardiac disease ( specified in\r\n             protocol)\r\n\r\n          -  ECG with any clinically significant abnormality.\r\n\r\n          -  Structural or functional cardiac abnormalities (specified in protocol)\r\n\r\n          -  History of COPD, emphysema, or other chronic lung disease.\r\n\r\n          -  Subjects currently abusing amphetamines, cocaine or opiates, or with ongoing alcohol\r\n             abuse in the judgement of the investigator\r\n      ","sponsor":"Alexion Pharmaceuticals","sponsor_type":"Industry","conditions":"Hepatitis C, Chronic","interventions":[{"intervention_type":"Drug","name":"Drug: Sovaprevir","description":"NS3/4A protease inhibitor"},{"intervention_type":"Drug","name":"Drug: ACH-3102","description":"NS5A inhibitor"},{"intervention_type":"Drug","name":"Drug: RBV"},{"intervention_type":"Drug","name":"Drug: Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of Sustained Virologic Response 4 Weeks (SVR4) After the Completion of Treatment.","time_frame":"Four weeks after the completion of treatment","description":"Incidence of SVR4 after the completion of dosing, reported as HCV RNA less than the lower limit of quantification (<LLOQ), in subjects who received active treatment (sovaprevir and ACH-0143102 in combination with ribavirin) as compared to those who received placebo."},{"outcome_type":"primary","measure":"Safety and Tolerability of 12 Weeks of Sovaprevir and 3102 in Combination With Ribavirin in Subjects With Chronic Hepatitis C Genotype 1 Viral Infection.","time_frame":"12 weeks","description":"To determine safety and tolerability of 12 weeks of sovaprevir/ACH-0143102/RBV in subjects with chronic hepatitis C genotype 1, the following criteria will be used: the number of subjects with discontinuations due to AEs, treatment emergent G3/G4 AEs, treatment emergent G3/G4 laboratory abnormalities, clinically significant ECGs."}]}
{"nct_id":"NCT01674868","start_date":"2013-04-30","phase":"N/A","enrollment":0,"brief_title":"Fluoxetine for Motor, Aphasia, and Neglect Recovery After Ischemic Stroke","official_title":"Pilot RCT of Fluoxetine vs Placebo to Treat Motor, Language and Unilateral Neglect After Ischemic Stroke","primary_completion_date":"2015-12-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2015-12-31","last_update":"2015-06-16","description":"This pilot study will recruit 25 subjects to assess the feasibility of replicating the FLAME study (Chollet, et al. Lancet 2011), a randomized controlled trial (RCT) that assessed the effect of fluoxetine vs placebo on motor recovery after ischemic stroke, in an American sample of post-acute stroke patients. This trial will in addition examine the effect of treatment with fluoxetine versus placebo on concurrent deficits in language and hemispatial attention, as well as post-stroke fatigue and will evaluate the durability of observed effects. The results of this pilot trial will be used to develop power estimates for a larger trial and to evaluate recruitment and intervention completion rates for subjects in an American post-acute environment. There are two additional substudies: the first will use MRI to assess structural changes at the beginning and end of the intervention; the second will examine the relationship of serum biomarkers of inflammation to the intervention.","other_id":"FLAN SpauldingRH","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Ischemic infarction within 15 days\r\n\r\n          -  Admission NIHSS item 5 score equal to or >2 -Able to give informed consent, with\r\n             surrogate consent acceptable-\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pre-stroke modified Rankin Scale score equal or .3\r\n\r\n          -  Pregnant or lactating\r\n\r\n          -  Taking an SSRI on admission to SRH\r\n\r\n          -  Taking a medication likely to have adverse interaction with an SSRI\r\n\r\n          -  Unable to return for follow-up testing days 90,180\r\n\r\n          -  Concurrent medial condition likely to worsen patient's functional status over next 6\r\n             months\r\n\r\n          -  Unable to competently participate in testing for 45min-2hrs with rest breaks\r\n\r\n          -  for MRI substudy: contraindication to MRI\r\n      ","sponsor":"Spaulding Rehabilitation Hospital","sponsor_type":"Other","conditions":"Stroke","interventions":[{"intervention_type":"Drug","name":"Drug: fluoxetine","description":"20 mg daily for 90 days starting day 5-10 after stroke."},{"intervention_type":"Drug","name":"Drug: placebo","description":"subjects will take one pill po daily for 90 days."}],"outcomes":[{"outcome_type":"primary","measure":"Fugl-Meyer Motor Scale (FMMS)","time_frame":"baseline to 90 days","description":"change in FMMS score"},{"outcome_type":"primary","measure":"Fugl-Meyer Motor Scale (FMMS)","time_frame":"baseline to 180 days","description":"change in FMMS"},{"outcome_type":"secondary","measure":"Western Aphasia Battery","time_frame":"baseline to 90 days","description":"change in Western Aphasia Quotient"},{"outcome_type":"secondary","measure":"Behavioral Inattention Test (BIT)","time_frame":"baseline to 90 days","description":"change in BIT"},{"outcome_type":"secondary","measure":"Behavioral Inattention Test (BIT)","time_frame":"baseline to 180 days","description":"change in BIT"},{"outcome_type":"secondary","measure":"Functional Independence Measure","time_frame":"baseline to discharge","description":"change in FIM"},{"outcome_type":"secondary","measure":"Fatigue Severity Scale","time_frame":"baseline to 90 days"},{"outcome_type":"secondary","measure":"Beck Depression Inventory","time_frame":"baseline to 90 days"},{"outcome_type":"secondary","measure":"Western Aphasia Battery","time_frame":"baseline to 180 days","description":"change in Western Aphasia Quotient"},{"outcome_type":"secondary","measure":"Beck Depression Inventory","time_frame":"baseline to 180 days"},{"outcome_type":"secondary","measure":"Fatigue Severity Scale","time_frame":"baseline to 180 days"},{"outcome_type":"secondary","measure":"modified Rankin Scale","time_frame":"baseline to 90 days"},{"outcome_type":"secondary","measure":"modified Rankin Scale","time_frame":"baseline to 180 days"}]}
{"nct_id":"NCT01906242","start_date":"2013-04-30","phase":"N/A","enrollment":40,"brief_title":"Hygiene Protocol of Complete Dentures","official_title":"Hygiene Protocols for Cleaning Complete Dentures","primary_completion_date":"2013-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-12-31","last_update":"2018-11-15","description":"Adequate denture hygiene is important to patient's oral health maintenance in particular because of Candida albicans, responsible for the development of denture stomatitis. The aim of this study is to conduct a randomized controlled trial seeking for the best hygiene protocols to be used in removable denture wearers. The null hypothesis tested is that there will be no difference among the denture hygiene protocols tested.","other_id":"PPGO016","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Prevention","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":40,"maximum_age":90,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Complete denture wearer\r\n\r\n          -  healthy\r\n\r\n          -  ability to comply with the experimental protocol\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Candidiasis (thrush)\r\n\r\n          -  use of antifungals, antibiotics or mouthwashes in the prior 3 months\r\n\r\n          -  limited motor activity\r\n\r\n          -  unhealthy\r\n      ","sponsor":"Federal University of Pelotas","sponsor_type":"Other","conditions":"Denture Hygiene Protocol","interventions":[{"intervention_type":"Other","name":"Other: sodium hypochlorite"},{"intervention_type":"Other","name":"Other: sodium bicarbonate"},{"intervention_type":"Other","name":"Other: chlorhexidine"},{"intervention_type":"Other","name":"Other: water"}],"outcomes":[{"outcome_type":"primary","measure":"Amount of biofilm formed on the denture","time_frame":"14 days","description":"Biofilm will be measured on the denture using photographs and microbial counts (baseline and after 14 days of use of one of the four hygiene protocols) after using one of the tested denture hygiene protocols. The four tested protocols (NaOCl, chlorhexidine, sodium bicarbonate, water) will be compared to see which one leads to a better hygiene of the denture."},{"outcome_type":"secondary","measure":"Odor","time_frame":"14 days","description":"Patients will be asked about the odor of the solution used to soak dentures through a questionnaire"}]}
{"nct_id":"NCT01766687","start_date":"2013-04-30","phase":"N/A","enrollment":822,"brief_title":"Impact of Increased Water Intake in Chronic Kidney Disease","official_title":"A Randomized Controlled Trial of Increased Water Intake in Chronic Kidney Disease","primary_completion_date":"2017-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-06-30","last_update":"2017-08-25","description":"The investigators have designed a randomized controlled trial to test whether increased water intake slows renal decline in patients with Stage-III Chronic Kidney Disease. Participants randomized to the hydration-intervention group will be asked to drink 1.0 to 1.5 L of water per day (depending on sex and weight), in addition to usual fluid intake, for one year. The investigators will calculate the change in kidney function (estimated glomerular filtration rate, measured every three months for 12 months), and compare renal decline between the intervention and control groups. The investigators hypothesize that increased water intake will slow renal decline.","other_id":"S-London RCT","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age 18-80 years\r\n\r\n          -  Able to provide informed consent and willing to complete follow-up visits.\r\n\r\n          -  Estimated glomerular filtration rate between 30 and 60 ml/min/1.73m2\r\n\r\n          -  Trace protein or greater (Albustix) or urine albumin/creatinine ratio >2.8 mg/mmol (if\r\n             female) or >2.0 mg/mmol (if male) from a random spot urine sample\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Self-reported fluid intake >10 cups/day or 24-hr urine volume >3L.\r\n\r\n          -  Enrolled in another trial that could influence the intervention, outcomes or data\r\n             collection of this trial (or previously enrolled in this trial)\r\n\r\n          -  Received one or more dialysis treatments in the past month\r\n\r\n          -  Kidney transplant within past six months (or on waiting list)\r\n\r\n          -  Pregnant or breastfeeding\r\n\r\n          -  History of kidney stones in past 5 years\r\n\r\n          -  Less than two years life expectancy\r\n\r\n          -  Serum sodium <130 mEq/L without suitable explanation\r\n\r\n          -  Serum calcium >2.6 mmol/L without suitable explanation\r\n\r\n          -  Currently taking hydrochlorothiazide >25 mg/d, indapamide >1.25 mg/d, furosemide >40\r\n             mg, or metolazone >2.5 mg/d\r\n\r\n          -  Currently taking lithium\r\n\r\n          -  Patient is under fluid restriction (<1.5 L a day) for kidney disease, heart failure,\r\n             or liver disease, AND meets any of the following criteria: i) end stage of the disease\r\n             (heart left ventricular ejection fraction <40%, NYHA class 3 or 4, or end stage\r\n             cirrhosis) or ii) hospitalization secondary to heart failure, ascites and/or anasarca\r\n\r\n          -  Patient has GI disease (history of inflammatory bowel disease, Crohns, etc.)\r\n      ","sponsor":"Lawson Health Research Institute","sponsor_type":"Other","conditions":"Chronic Kidney Disease","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Hydration"}],"outcomes":[{"outcome_type":"primary","measure":"Renal decline","time_frame":"Baseline and 12 months","description":"Change in estimated glomerular filtration rate between baseline and 12 months"},{"outcome_type":"secondary","measure":"24-hour urine albumin","time_frame":"Baseline and 12 months","description":"Change in 24-hour urine albumin between baseline and 12 months"},{"outcome_type":"secondary","measure":"Rapid renal decline","time_frame":"Baseline and 12 months","description":"Proportion with eGFR (estimated glomerular filtration rate) decline >5% between baseline and 12 months"},{"outcome_type":"secondary","measure":"Measured creatinine clearance","time_frame":"Baseline and 12 months","description":"Change in measured creatinine clearance between baseline and 12 months"},{"outcome_type":"secondary","measure":"Health-related quality of life","time_frame":"Baseline and 12 months","description":"Change in health-related quality of life between baseline and 12 months"},{"outcome_type":"secondary","measure":"Copeptin","time_frame":"Baseline and 12 months","description":"Change in copeptin between baseline and 12 months"},{"outcome_type":"other","measure":"Body Mass Index","time_frame":"Baseline and 12 months","description":"Change in Body Mass Index between baseline and 12 months"},{"outcome_type":"other","measure":"Blood pressure","time_frame":"Baseline and 12 months","description":"Change in mean arterial blood pressure between baseline and 12 months"},{"outcome_type":"other","measure":"HbA1c","time_frame":"Baseline and 12 months","description":"Change in HbA1c between between baseline and 12 months"},{"outcome_type":"other","measure":"Long-term renal decline","time_frame":"Baseline and 24 months","description":"Change in estimated glomerular filtration rate between baseline and 24 months"},{"outcome_type":"other","measure":"Effect of fluid coaching on adherence","time_frame":"12 and 24 months","description":"Change in urine volume between 12 months and 24-months follow-up"}]}
{"nct_id":"NCT01691014","start_date":"2013-04-30","enrollment":79,"brief_title":"Formation of Antibodies and Subsequent Prediction of Clinical Response in Patients With Rheumatoid Arthritis Treated With Four TNF Blocking Agents","official_title":"Formation Of Antibodies And Subsequent Prediction Of Clinical Response In Patients With Rheumatoid Arthritis Treated With Four Tnf Blocking Agents","primary_completion_date":"2015-01-31","study_type":"Observational","rec_status":"Terminated","completion_date":"2015-01-31","last_update":"2016-12-29","description":"The rationale for this study is to further explore if development of antibodies against TNF- blocking agents is associated with reduced clinical effect/worsened clinical outcome. An important aspect of the study is to carry out an exploratory analysis of the immunogenicity of the 4 recommended TNF- blockers in the treatment of RA in Denmark, using the same cell-based assay.","other_id":"B1801347","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"patients with Rheumatoid Arthritis (RA)","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subject fulfils criteria for Rheumatoid Arthritis (RA) according to ACR or EULAR\r\n             criteria.\r\n\r\n          -  Subjects who are planned to start treatment with ADA, ETA, CER or IFX\r\n\r\n          -  Subjects taking a minimum weekly dose of 7.5 mg of methotrexate\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with compliance problems\r\n\r\n          -  Patients who have difficulties in reading and understanding local language\r\n\r\n          -  Patients with Juvenile Idiopathic Arthritis (JIA)\r\n\r\n          -  Azathioprine or cyclophosphamide treatment within 6 months before entering into the\r\n             study\r\n      ","sponsor":"Pfizer","sponsor_type":"Industry","conditions":"Rheumatoid Arthritis (RA)","interventions":[{"intervention_type":"Other","name":"Other: non-interventional study","description":"Study with 4 arms/groups with 36 patients per group. In total 144 patients."},{"intervention_type":"Other","name":"Other: non-interventional study","description":"Study with 4 arms/groups with 36 patients per group. In total 144 patients."},{"intervention_type":"Other","name":"Other: non-interventional study","description":"Study with 4 arms/groups with 36 patients per group. In total 144 patients."},{"intervention_type":"Other","name":"Other: non-interventional study","description":"Study with 4 arms/groups with 36 patients per group. In total 144 patients."}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants With Anti-drug Antibodies Formation Levels 6 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab","time_frame":"Month 6","description":"Anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay."},{"outcome_type":"primary","measure":"Number of Participants With Presence of Active Drugs in Serum 6 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab","time_frame":"Month 6","description":"Presence of active drugs in serum 6 months after treatment with Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay."},{"outcome_type":"secondary","measure":"Correlation Between Formation of Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab 6 Months After Initiation of Treatment and Disease Activity Score 28 (DAS28) 12 Months After Initiation of Treatment","time_frame":"Month 6, 12","description":"Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept, Infliximab and DAS28 was to be analyzed using Pearson and Spearman correlations across and within each of the four treatment groups. DAS28-4 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joint count, C-reactive protein (CRP) in milligram per liter (mg/L) and participant global assessment (PGA) of disease activity (participant rated arthritis activity assessment with total score ranging from 0 [good condition] to 10 [worst condition]; higher score indicates worse condition). DAS28-4 total score range: 0 (no disease activity) to 9.4 (maximum disease activity), higher score indicates more disease activity."},{"outcome_type":"secondary","measure":"Correlation Between Formation of Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab 6 Months After Initiation of Treatment and Health Assessment Questionnaire (HAQ) 12 Months After Initiation of Treatment","time_frame":"Month 6, 12","description":"Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept, Infliximab and HAQ scores was to be analyzed using Pearson and Spearman correlations across and within each of the four treatment groups. HAQ was a self-reported, valid assessment of functional disability in rheumatoid arthritis based on ability of participants to perform daily activities. HAQ total score range: 0 (normal functioning) to 3 (worst functioning), where higher score indicates worse functioning."},{"outcome_type":"secondary","measure":"Correlation Between Formation of Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab 6 Months After Initiation of Treatment and Cessation of Therapy Between Month 6 and 12 Visits","time_frame":"Month 6, 12","description":"Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab and cessation of therapy was to be analyzed. Cessation of therapy between month 6 and month 12 was the time to withdrawal from study due to either adverse events or lack of effect between the 6 month visit and the 12 month visit."},{"outcome_type":"secondary","measure":"Number of Participants With Anti-drug Antibodies Levels 3 and 12 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab","time_frame":"Month 3, 12","description":"Anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay."},{"outcome_type":"secondary","measure":"Correlation Between the Formation of Anti-drug Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab and Concomitant Methotrexate Treatment","time_frame":"Month 12","description":"Association between formation of anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab and concomitant Methotrexate treatment (weekly dose of 7.5 milligram) was to be analyzed."},{"outcome_type":"secondary","measure":"Disease Activity Score Based on 28-Joints Count (DAS28) After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab at Month 3, 6 and 12","time_frame":"Month 3, 6, 12","description":"DAS28-4 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joint count, C-reactive protein (CRP) in milligram per liter (mg/L) and participant global assessment (PGA) of disease activity (participant rated arthritis activity assessment with total score ranging from 0 [good condition] to 10 [worst condition]; higher score indicates worse condition). DAS28-4 total score range: 0 (no disease activity) to 9.4 (maximum disease activity), higher score indicates more disease activity. DAS28-4 (CRP) less than or equal to (<=) 3.2 implied low disease activity and greater than (>) 3.2 to 5.1 implied moderate to high disease activity."},{"outcome_type":"secondary","measure":"Health Assessment Questionnaire (HAQ) Score After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab at Baseline, Month 3, 6 and 12","time_frame":"Baseline, Month 3, 6, 12","description":"HAQ was a self-reported, valid assessment of functional disability in rheumatoid arthritis based on ability of participants to perform daily activities. HAQ total score range: 0 (normal functioning) to 3 (worst functioning), where higher score indicates worse functioning."}]}
{"nct_id":"NCT01841593","start_date":"2013-04-30","phase":"Phase 1","enrollment":19,"brief_title":"A Two Way Cross Over Pharmacokinetic Interaction Study Between Raltegravir and Amlodipine in Healthy Volunteers","official_title":"A Two Way Cross Over Pharmacokinetic (PK) Interaction Study Between Raltegravir and Amlodipine in Healthy Volunteers","primary_completion_date":"2013-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-09-30","last_update":"2014-09-29","description":"The purpose of the study is to look at the levels of an HIV medication (raltegravir) in the blood, and how it is affected if raltegravir is taken at the same time as another medicine for high blood pressure (amlodipine). Many patients with HIV will also have high blood pressure, so it is important to know which drugs for each of these conditions can be taken together without affecting how well they work individually. Over a 3 week period, participants took amlodipine for 2 weeks, and raltegravir for 2 weeks, with the middle week being on both drugs. The investigators will look at and compare the levels of these two drugs in the blood after subjects have taken them separately and both together. This study is randomised into two groups with both study medications received by all participants in a three-period crossover pattern; randomisation determined which medication was taken first. Once randomised allocation was performed, medications were administered in an open-label fashion.","other_id":"SSAT 051","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Subjects must meet all of the following inclusion criteria within 28 days prior to the\r\n        baseline visit:\r\n\r\n          -  The ability to understand and sign a written informed consent form, prior to\r\n             participation in any screening procedures and must be willing to comply with all study\r\n             requirements\r\n\r\n          -  Male or non-pregnant, non-lactating females\r\n\r\n          -  Between 18 to 65 years, inclusive\r\n\r\n          -  Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive.\r\n\r\n          -  Women of childbearing potential (WOCBP) must be using an adequate method of\r\n             contraception to avoid pregnancy throughout the study and for a period of at least 12\r\n             weeks after the study\r\n\r\n          -  Willing to consent to their personal details being entered onto The Over-volunteering\r\n             Prevention Scheme (TOPS) database\r\n\r\n          -  Willing to provide photographic identification at each visit.\r\n\r\n          -  Registered with a GP in the UK\r\n\r\n        Exclusion Criteria:\r\n\r\n        Subjects who meet any of the following exclusion criteria are not to be enrolled in this\r\n        study.\r\n\r\n          -  Any significant acute or chronic medical illness including hypertension (BP\r\n             persistently >140/90 mmHg) or hypotension (BP persistently <90/60 mmHg)\r\n\r\n          -  Evidence of organ dysfunction or any clinically significant deviation from normal in\r\n             physical examination, vital signs, ECG or clinical laboratory determinations\r\n\r\n          -  Positive blood screen for hepatitis B surface antigen and/or C antibodies\r\n\r\n          -  Positive blood screen for HIV-1 and/or 2 antibodies\r\n\r\n          -  Current or recent (within 3 months) gastrointestinal disease\r\n\r\n          -  Clinically relevant alcohol or drug use (positive urine drug screen) or history of\r\n             alcohol or drug use considered by the Investigator to be sufficient to hinder\r\n             compliance with treatment, follow-up procedures or evaluation of adverse events.\r\n             Smoking is permitted, but tobacco intake should remain consistent throughout the study\r\n\r\n          -  Exposure to any investigational drug or placebo within 3 months of first dose of study\r\n             drug\r\n\r\n          -  Use of any other drugs (unless approved by the Investigator), including\r\n             over-the-counter medications and herbal preparations, within two weeks prior to first\r\n             dose of study drug, unless approved/prescribed by the Principal Investigator as known\r\n             not to interact with study drugs.\r\n\r\n          -  Females of childbearing potential without the use of effective non-hormonal birth\r\n             control methods, or not willing to continue practising these birth control methods for\r\n             at least 12 weeks after the end of the treatment period\r\n\r\n          -  Previous allergy to any of the constituents of the pharmaceuticals administered in\r\n             this trial\r\n\r\n          -  Lactose intolerance\r\n      ","sponsor":"St Stephens Aids Trust","sponsor_type":"Other","conditions":"HIV","interventions":[{"intervention_type":"Drug","name":"Drug: Amlodipine","description":"generic amlodipine 5mg tablets (Accord healthcare Limited, UK)"},{"intervention_type":"Drug","name":"Drug: Raltegravir","description":"Isentress 400mg tablet taken twice daily"}],"outcomes":[{"outcome_type":"primary","measure":"Maximum Observed Concentration (Cmax) of Raltegravir and Amlodipine Without and With Co-administration of the Other Studied Drug.","time_frame":"Day 7 of each intervention (0 (pre-dose), 2, 4, 8 and 12 hours post dose (both drugs) and 24 hours post dose (amlodipine only))","description":"To investigate the pharmacokinetics of raltegravir and amlodipine co-administration. The pharmacokinetic parameters calculated for raltegravir and amlodipine will be trough concentration (Ctrough), defined as the concentration at 24 hours after the observed drug dose, the maximum observed plasma concentration (Cmax), elimination half-life (t1/2), time point at Cmax (Tmax), and total drug exposure, expressed as the area under the plasma concentration-time curve from 0-24 hours after dosing (AUC0-24h).\r\nAll pharmacokinetic parameters will be calculated using non-compartmental modeling techniques (WinNonlin®) and all statistical calculations performed and analyzed using SAS version 9.1 or SPSS V17.0."},{"outcome_type":"primary","measure":"Raltegravir C12h","time_frame":"12 hours post-dose on day 7 of daily dosing.","description":"measured concentration 12 hours after dose in the absence, and presence, of amlodipine."},{"outcome_type":"primary","measure":"Amlodipine C24h","time_frame":"12 hours post-dose on day 7 of daily dosing.","description":"measured concentration 24 hours after dose in the absence, and presence, of raltegravir"},{"outcome_type":"primary","measure":"Raltegravir AUC(0-12h )","time_frame":"Post dose after day 7 of daily dosing","description":"AUC0-12h: Area under the concentration time curve over 12 hours in the absence, and presence, of amlodipine."},{"outcome_type":"primary","measure":"Amlodipine AUC(0-24h)","time_frame":"Post-dose on day 7 of daily dosing","description":"AUC0-24h: Area under the concentration time curve 24 hours in the absence, and presence, of raltegravir"}]}
{"nct_id":"NCT01886859","start_date":"2013-04-26","phase":"Phase 1","enrollment":27,"brief_title":"Lenalidomide and Ibrutinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma","official_title":"A Dose Escalation Study of Ibrutinib With Lenalidomide for Relapsed and Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma","primary_completion_date":"2020-11-15","study_type":"Interventional","rec_status":"Active, not recruiting","last_update":"2021-06-30","description":"This phase I trial studies the side effects and best dose of lenalidomide when given together with ibrutinib in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory). Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving lenalidomide together with ibrutinib may work better in treating chronic lymphocytic leukemia or small lymphocytic lymphoma.","other_id":"NCI-2013-00888","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients must have a diagnosis of CLL/SLL or B-cell prolymphocytic leukemia, as\r\n             defined by the World Health Organization (WHO)\r\n\r\n          -  During dose escalation, patients must have received at least one prior therapy, need\r\n             additional cytoreduction, and meet criteria for relapsed or refractory disease;\r\n             relapsed disease is defined as a patient who previously achieved a CR or a PR, but\r\n             after a period of six or more months demonstrates evidence of disease progression;\r\n             refractory disease is defined as progression within six months of the last\r\n             anti-leukemic therapy, or any response less than a CR or PR; patients who are\r\n             previously untreated, and do not wish to receive chemotherapy or immunotherapy, are\r\n             eligible for the dose expansion portion of the study\r\n\r\n          -  Patients may have not received treatment for 28 days before the first day of the study\r\n             protocol (dose escalation only)\r\n\r\n          -  Estimated life expectancy greater than two months\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2\r\n\r\n          -  Ability to understand and willingness to sign a written informed consent document\r\n\r\n          -  Patients must have acceptable organ and marrow function, which should be present\r\n             independent of growth factor or transfusion support for at least 7 days prior to first\r\n             dose of study drug, with the exception of pegylated G-CSF (pegfilgrastim) and\r\n             darbopoeitin which require a 14-day period between dosing and first dose of study drug\r\n\r\n          -  Absolute neutrophil count (ANC) >= 750 cells/uL (0.75 x 10^9/L)\r\n\r\n          -  Platelets >= 50,000 cells/uL (50 x 10^9/L)\r\n\r\n          -  Hemoglobin > 8 mg/dL\r\n\r\n          -  Total bilirubin =< 1.5 x upper limit of normal (ULN) unless Gilbert's syndrome or\r\n             disease infiltration of the liver is present\r\n\r\n          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase\r\n             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])\r\n             =< 3.0 x ULN\r\n\r\n          -  Creatinine < 2.0 x ULN or creatinine clearance (estimated [est.] glomerular filtration\r\n             rate [GFR] [Cockcroft-Gault]) >= 30 mL/min\r\n\r\n          -  Prothrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and partial\r\n             thromboplastin time (PTT)/activated partial thromboplastin time (aPTT) < 1.5 x ULN\r\n\r\n          -  The effects of ibrutinib on the developing human fetus are unknown; lenalidomide is\r\n             likely to be teratogenic; therefore, females of childbearing potential (FCBP) must\r\n             have a negative pregnancy test (sensitivity of at least 25 mIU/mL) performed once\r\n             before ibrutinib and a total of two negative tests before initiating lenalidomide; a\r\n             FCBP is a female who: 1) has achieved menarche at some point; 2) has not undergone a\r\n             hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal\r\n             (amenorrhea following cancer therapy does not rule out childbearing potential) for at\r\n             least 24 consecutive months (i.e., has had menses at any time in the preceding 24\r\n             consecutive months); the pre-ibrutinib pregnancy test will be initiated at enrollment;\r\n             the first pre- lenalidomide test will be performed within 10-14 days of starting\r\n             lenalidomide (cycle 0, day 15), and the second pre-lenalidomide test (3rd total test)\r\n             will be within 24 hours of the first dose of lenalidomide; the patient may not receive\r\n             lenalidomide until the study doctor has verified that the results of these pregnancy\r\n             tests are negative; pregnancy tests (if applicable) are then to be conducted weekly\r\n             during the first month, and monthly thereafter in women with a regular menstrual\r\n             cycle, as well as at study discontinuation, and at day 28 following study\r\n             discontinuation; if menstrual cycles are irregular, pregnancy testing will be\r\n             conducted weekly for the first month, and then every 14 days while on the study, at\r\n             study discontinuation, and at days 14 and 28 following study drug discontinuation;\r\n             pregnancy testing and counseling are to be performed if a patient misses her period or\r\n             if there is any abnormality in menstrual bleeding; should a woman become pregnant or\r\n             suspect she is pregnant while she is participating in this study, she should inform\r\n             her treating physician immediately; further, FCBP must either commit to continued\r\n             abstinence from heterosexual intercourse or begin TWO acceptable methods of birth\r\n             control: one highly effective method and one additional effective method AT THE SAME\r\n             TIME, at least 28 days before starting lenalidomide; FCBP must also agree to ongoing\r\n             pregnancy testing; men must agree to use a latex condom during sexual contact with a\r\n             FCBP, even if they have had a successful vasectomy; male and female patients must\r\n             agree to use highly effective methods of birth control (e.g. condoms, implants,\r\n             injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete\r\n             sexual abstinence, or sterilized partner) during the period of therapy and for 90 days\r\n             after the last dose of study drug; all patients must be counseled by a trained\r\n             counselor every 28 days about pregnancy precautions and risks of fetal exposure\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior therapy with Bruton's tyrosine kinase (BTK) inhibitor\r\n\r\n          -  Concurrent treatment with other investigational or anti-neoplastic agents\r\n\r\n          -  Patients requiring daily corticosteroids at a prednisone equivalent of > 20 mg daily\r\n             should not be enrolled; if corticosteroids can be discontinued (or reduced to < 20 mg\r\n             per day of prednisone or equivalent), the discontinuation or dose reduction should be\r\n             done at least 7 days prior to first dose\r\n\r\n          -  Chemotherapy =< 21 days prior to first administration of study treatment and/or\r\n             monoclonal antibody =< 6 weeks prior to first administration of study treatment;\r\n             immunotherapy, radiotherapy or experimental therapy within 28 days of first day of\r\n             study drug dosing, or within six weeks of first day of study drug dosing in the event\r\n             that nitrosoureas or mitomycin were used; concurrent systemic immunosuppressant\r\n             therapy other than corticosteroids (e.g. cyclosporine A, tacrolimus, etc) must be\r\n             discontinued within 28 days of the first dose of study drug\r\n\r\n          -  Currently active clinically significant cardiovascular disease such as uncontrolled\r\n             arrhythmia, congestive heart failure, or any class 3 or 4 congestive heart failure as\r\n             defined by the New York Heart Association Functional Classification, or history of\r\n             myocardial infarction, unstable angina or acute coronary syndrome within 6 months\r\n             prior to on-study registration\r\n\r\n          -  Uncontrolled psychiatric illness that would limit compliance with study requirements\r\n\r\n          -  Central nervous system disease involvement; these patients should be excluded from\r\n             this clinical trial because of their poor prognosis and because they often develop\r\n             progressive neurologic dysfunction that would confound the evaluation of neurologic\r\n             and other adverse events\r\n\r\n          -  History of prior malignancy, with the exception of the following:\r\n\r\n               -  Malignancy treated with curative intent and with no evidence of active disease\r\n                  present for more than 3 years prior to screening, and felt to be at low risk for\r\n                  recurrence by treating physician\r\n\r\n               -  Adequately treated non-melanomatous skin cancer or lentigo maligna melanoma\r\n                  without current evidence of disease\r\n\r\n               -  Adequately treated cervical carcinoma in situ without current evidence of disease\r\n\r\n          -  Serologic status reflecting active hepatitis B or C infection; patients that are\r\n             hepatitis B core antibody, hepatitis B surface antigen (HBsAg) or hepatitis C antibody\r\n             must have a negative polymerase chain reaction (PCR) prior to enrollment; PCR positive\r\n             patients will be excluded\r\n\r\n          -  Active infection at initiation of study; recent infections requiring systemic\r\n             treatment need to have completed therapy > 14 days before the first dose of study drug\r\n\r\n          -  Major surgery within 4 weeks or minor surgery within 7 days of the first day of study\r\n             drug dosing\r\n\r\n          -  Unable to swallow capsules or disease significantly affecting gastrointestinal\r\n             function or resection of the stomach or small bowel, or symptomatic inflammatory bowel\r\n             disease or ulcerative colitis or partial or complete bowel obstruction\r\n\r\n          -  Prior allogeneic stem cell transplantation\r\n\r\n          -  Active, uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic\r\n             purpura (ITP)\r\n\r\n          -  Presence of transfusion-dependent thrombocytopenia or a history of bleeding disorders\r\n             or clinical conditions (e.g. gastrointestinal [GI] bleeding or constitutional\r\n             disorders) that may increase risk of life-threatening bleeding when thrombocytopenic\r\n\r\n          -  History of stroke or intracranial hemorrhage within 6 months prior to enrollment\r\n\r\n          -  History of allergic reactions attributed to compounds of similar chemical or biologic\r\n             composition to ibrutinib or lenalidomide\r\n\r\n          -  Patients who received a strong cytochrome P450 (CYP) 3A inhibitor within 7 days prior\r\n             to the first dose of ibrutinib or patients who require continuous treatment with a\r\n             strong CYP3A inhibitor\r\n\r\n          -  Requires or is receiving anticoagulation with warfarin or equivalent vitamin K\r\n             antagonists (e.g.: phenprocoumon) within 28 days of the first dose of study drug\r\n\r\n          -  Pregnant women are excluded from this study because ibrutinib and lenalidomide have\r\n             the potential for teratogenic or abortifacient effects; because there is an unknown\r\n             but potential risk for adverse events in nursing infants secondary to treatment of the\r\n             mother with ibrutinib and lenalidomide, breastfeeding should be discontinued if the\r\n             mother is treated with either agent, and for 30 days after discontinuation of therapy\r\n\r\n          -  Current life-threatening illness, medical condition, or organ system dysfunction\r\n             which, in the investigator's opinion, could compromise the patient's safety, or put\r\n             the study at risk\r\n\r\n          -  Human immunodeficiency virus (HIV)-positive patients with cluster of differentiation 4\r\n             (CD4) counts less than the lower limit of institutional normal\r\n\r\n          -  HIV-positive patients requiring antivirals which are cytochrome P450 (CYP) interactive\r\n             with the investigational agents (CYP3A4 strong inducers and inhibitors)\r\n\r\n          -  Other laboratory abnormalities that, in the opinion of the investigator, would\r\n             compromise the patient's safety or interfere with data interpretation\r\n\r\n          -  Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug\r\n\r\n          -  Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved\r\n             to Common Terminology Criteria for Adverse Event (CTCAE, version 5), grade =< 1, or to\r\n             the levels dictated in the inclusion/exclusion criteria with the exception of alopecia\r\n\r\n          -  Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia\r\n\r\n          -  Unwilling or unable to participate in all required study evaluations and procedures\r\n\r\n          -  Currently active, clinically significant hepatic impairment (>= moderate hepatic\r\n             impairment according to the National Cancer Institute (NCI)/Child Pugh classification)\r\n      ","sponsor":"National Cancer Institute (NCI)","sponsor_type":"NIH","conditions":"Recurrent B-Cell Prolymphocytic Leukemia|Recurrent Chronic Lymphocytic Leukemia|Recurrent Small Lymphocytic Lymphoma|Refractory B-Cell Prolymphocytic Leukemia|Refractory Chronic Lymphocytic Leukemia|Refractory Small Lymphocytic Lymphoma","interventions":[{"intervention_type":"Drug","name":"Drug: Ibrutinib","description":"Given PO"},{"intervention_type":"Drug","name":"Drug: Lenalidomide","description":"Given PO"}],"outcomes":[{"outcome_type":"primary","measure":"Maximum tolerated dose of lenalidomide when combined with ibrutinib","time_frame":"28 days","description":"Defined as the highest dose in which less than or equal to 1/6 patients have dose limiting toxicity. Assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. All patient safety information collected will be summarized using descriptive statistics (number of non-missing values, mean, median, standard deviation, minimum and maximum) for continuous variables and counts and percentages for categorical variables, where applicable."},{"outcome_type":"secondary","measure":"Response rates","time_frame":"Up to 12 months","description":"Response rates will be calculated based on all the intention-to-treat subjects and reported along with its exact 95% confidence interval."},{"outcome_type":"secondary","measure":"Remission/response duration","time_frame":"Up to 90 days","description":"Remission/response duration is measured from the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Response duration will be calculated, and the mean, median, minimum, and maximum values will be reported."},{"outcome_type":"other","measure":"Non-compartmental areas under the curve (AUCs) for ibrutinib","time_frame":"Up to day 1 of cycle 2","description":"The impact of lenalidomide on pharmacokinetics of ibrutinib will be evaluated by comparisons of non-compartmental AUCs for ibrutinib on cycle 0, day 8 versus cycle 2, day 1."},{"outcome_type":"other","measure":"Ability of ibrutinib to bind to its targets","time_frame":"Up to day 1 of cycle 2","description":"The impact of lenalidomide on ibrutinib binding to Bruton's tyrosine kinase and interleukin-2 inducible kinase will be evaluated, and the mechanistic interactions between the two agents will be investigated."},{"outcome_type":"other","measure":"Percentage of occupancy","time_frame":"Up to day 1 of cycle 2","description":"Defined as the ratio between the signal pre-dose and the signal post-dose. More than 95% occupancy is defined as full occupancy."},{"outcome_type":"other","measure":"Change in Rho guanosine triphosphate (GTP)ase levels","time_frame":"Baseline to up to day 1 of cycle 2","description":"Comparison of Rho GTPase expression and activation levels, as well as migration before and after treatment with lenalidomide, will be performed using a paired Student t test. The predictive power of the clinical and laboratory values measured for purposes of biomarker discover will be assessed by a multiple comparison analysis of variance test."}]}
{"nct_id":"NCT01801917","start_date":"2013-04-24","phase":"Phase 2","enrollment":14,"brief_title":"Efficacy and Tolerability of BAF312 in Patients With Polymyositis","official_title":"A Multi-centre Double-blind, Placebo Controlled, Proof of Concept Study to Evaluate the Efficacy and Tolerability of BAF312 in Patients With Polymyositis","primary_completion_date":"2016-08-05","study_type":"Interventional","rec_status":"Terminated","completion_date":"2016-08-05","last_update":"2021-01-05","description":"This study assessed the efficacy, safety and tolerability of BAF312 administered orally in patients with clinically active polymyositis and also in patients with polymyositis who had shown inadequate response to corticosteroids and or DMARDs (disease modifying antirheumatic drugs).","other_id":"CBAF312X2205","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  \"definite\" or \"probable\" for polymyositis at least three months before Baseline\r\n\r\n          -  active disease as defined by elevated CK levels, or other enzymes, or MRI/biopsy if\r\n             enzymes are normal, and persisting muscle weakness\r\n\r\n          -  stable dose of corticosteroid for at least 2 weeks prior to Baseline and should not\r\n             have received a medium or high dose in the last 8 weeks prior to study entry.\r\n\r\n          -  patients treated with methotrexate must have been on a stable dose for at least 6\r\n             weeks prior to Baseline.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with overlap polymyositis, late-stage polymyositis, or other types of\r\n             myositis.\r\n\r\n          -  Preexisting severe cardiac or pulmonary involvement, malignancy of any organ system or\r\n             significant eye diseases.\r\n\r\n          -  Uncontrolled diabetes mellitus or diabetes complicated with organ involvement.\r\n\r\n          -  Pregnant or nursing (lactating) women\r\n      ","sponsor":"Novartis Pharmaceuticals","sponsor_type":"Industry","conditions":"Polymyositis","interventions":[{"intervention_type":"Drug","name":"Drug: Placebo","description":"Matching placebo tablet for oral administration"},{"intervention_type":"Drug","name":"Drug: BAF312","description":"BAF312 in 4 dosage strengths in tablet form: 0.25 mg, 0.5 mg, 1 mg, 2 mg for oral administration"}],"outcomes":[{"outcome_type":"primary","measure":"Change From Baseline at Week 12 for BAF312 2 mg, 10 mg or Placebo (Once Daily) for Combined Efficacy Endpoint: Manual Muscle Testing in 24 Muscles (MMT24)","time_frame":"Baseline, at 12 weeks","description":"Manual Muscle Testing Scoring Sheet: Neck flexors, neck extensors and other designated muscles bilaterally (Biceps brachii, Deltoid middle, Quadriceps, Gluteus maximus, Gluteus medius, Trapezius, Iliopsoas, Hamstrings, Wrist extensors, Wrist Flexors, Ankle plantar flexors and Ankle dorsiflexors) were tested on a 0-10 scale by the Investigator. Posterior credibility interval from Bayesian analysis displayed as confidence interval. The scores range was 0 to 260. Higher scores indicate better outcome."},{"outcome_type":"primary","measure":"Percent Change From Baseline at Week 12 for BAF312 2 mg, 10 mg or Placebo (Once Daily) Serum Creatine Kinase (CK) Levels","time_frame":"Baseline, at 12 weeks","description":"Serum creatine kinase (CK) were analyzed as part of the blood chemistry panel. Posterior credibility interval from Bayesian analysis displayed as confidence interval. The variable CK was log-transformed for statistical analysis and after estimation was converted to percent change from baseline divided by the mean baseline"},{"outcome_type":"secondary","measure":"Six-minute Walking Distance (6MWD) at Week 12","time_frame":"Baseline, 12 weeks","description":"This test assessed the distance a patient could walk in 6 minutes (Rutkove et al 2002). If the patient was not able to walk for 6 minutes then a 2 minute walking test was conducted"},{"outcome_type":"secondary","measure":"Six-minute Walking Distance (6MWD) at Week 24","time_frame":"Baseline, 24 weeks","description":"This test assessed the distance a patient could walk in 6 minutes (Rutkove et al 2002). If the patient was not able to walk for 6 minutes then a 2 minute walking test was conducted"},{"outcome_type":"secondary","measure":"BAF312 Trough Plasma Concentrations (PK Set)","time_frame":"-7 Baseline, day 28, 56, 84","description":"All blood samples were taken by either direct venipuncture or an indwelling cannula inserted in a forearm vein. For each sample, approximately 2 mL of blood was drawn. BAF312 was determined in ethylenediaminetetraacetic acid (EDTA) plasma using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) bioanalytical method for the quantification. The anticipated lower limit of quantification (LLOQ) was 0.02 ng/mL using 0.1 mL of plasma"}]}
{"nct_id":"NCT01498770","start_date":"2013-04-01","enrollment":42,"brief_title":"An Observational Drug Utilization Study of Asenapine in the United Kingdom (P08308)","official_title":"An Observational Drug Utilization Study of SYCREST^ (Asenapine) in the United Kingdom","primary_completion_date":"2017-12-21","study_type":"Observational","rec_status":"Completed","completion_date":"2017-12-21","last_update":"2018-03-01","description":"This study is designed to describe asenapine prescribing patterns in the United Kingdom (UK) during the post-approval period under conditions of usual practice. The use of asenapine in Bipolar Disorder and other indications will be described. To provide epidemiological and clinical perspective, use of aripiprazole and other comparator drugs will be described.","other_id":"P08308","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","population":"The study population is drawn from UK general practitioner practices participating in CPRD.\r\n        The database is generally representative of the UK general population.","criteria":"\n        Inclusion Criteria for Participants Treated with Asenapine:\r\n\r\n          -  At least 1 prescription for asenapine within the study period\r\n\r\n          -  Date of prescription occurs after the CPRD subject registration date or the database\r\n             specific quality indicator date\r\n\r\n          -  A minimum of 365 or more days of evaluable baseline observation time, occurring prior\r\n             to the date of prescription for asenapine\r\n\r\n        Inclusion Criteria for Participants Treated with a Comparator:\r\n\r\n          -  Age 18 years or greater at the time participant receives a prescription for the\r\n             comparator\r\n\r\n          -  At least 1 prescription for either aripiprazole, quetiapine, risperidone, olanzapine,\r\n             ziprasidone, iloperidone, paliperidone, lurasidone, clozapine, amisulpride, sertindole\r\n             or zotepine within the study period\r\n\r\n          -  Date of prescription occurs after the CPRD subject registration date or the database\r\n             specific quality indicator date\r\n\r\n          -  A minimum of 365 or more days of evaluable baseline observation time, occurring prior\r\n             to the date of prescription for either aripiprazole, quetiapine, risperidone,\r\n             olanzapine, ziprasidone, iloperidone, paliperidone, lurasidone, clozapine,\r\n             amisulpride, sertindole or zotepine\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  None\r\n      ","sponsor":"Merck Sharp & Dohme Corp.","sponsor_type":"Industry","conditions":"Bipolar Disorder","interventions":[{"intervention_type":"Drug","name":"Drug: Amisulpride","description":"Amisulpride prescribed as recorded in the CPRD in the UK"},{"intervention_type":"Drug","name":"Drug: Sertindole","description":"Sertindole prescribed as recorded in the CPRD in the UK"},{"intervention_type":"Drug","name":"Drug: Zotepine","description":"Zotepine prescribed as recorded in the CPRD in the UK"},{"intervention_type":"Drug","name":"Drug: Clozapine","description":"Clozapine prescribed as recorded in the CPRD in the UK"},{"intervention_type":"Drug","name":"Drug: Asenapine","description":"Asenapine prescribed as recorded in the CPRD in the UK"},{"intervention_type":"Drug","name":"Drug: Aripiprazole","description":"Aripiprazole prescribed as recorded in the CPRD in the UK"},{"intervention_type":"Drug","name":"Drug: Quetiapine","description":"Quetiapine prescribed as recorded in the CPRD in the UK"},{"intervention_type":"Drug","name":"Drug: Risperidone","description":"Risperidone prescribed as recorded in the CPRD in the UK"},{"intervention_type":"Drug","name":"Drug: Olanzapine","description":"Olanzapine prescribed as recorded in the CPRD in the UK"},{"intervention_type":"Drug","name":"Drug: Ziprasidone","description":"Ziprasidone prescribed as recorded in the CPRD in the UK"},{"intervention_type":"Drug","name":"Drug: Iloperidone","description":"Iloperidone prescribed as recorded in the CPRD in the UK"},{"intervention_type":"Drug","name":"Drug: Paliperidone","description":"Paliperidone prescribed as recorded in the CPRD in the UK"},{"intervention_type":"Drug","name":"Drug: Lurasidone","description":"Lurasidone prescribed as recorded in the CPRD in the UK"}],"outcomes":[{"outcome_type":"primary","measure":"Frequency and Proportion of Use, by Psychiatric Diagnosis, Among Asenapine and Aripiprazole Participants Aged 18 or Greater","time_frame":"From baseline through 730 days after date of prescription"},{"outcome_type":"primary","measure":"Frequency and Proportion of Use Among Asenapine and Aripiprazole Participants Aged 18 or Greater with Schizophrenia and No Diagnosis of Bipolar Disorder","time_frame":"From baseline through 730 days after date of prescription"},{"outcome_type":"primary","measure":"Frequency and Proportion of Use Among Asenapine and Aripiprazole Participants Aged 18 or Greater with No Diagnosis of Bipolar Disorder or Schizophrenia, by Other Diagnosis","time_frame":"From baseline through 730 days after date of prescription"},{"outcome_type":"primary","measure":"Baseline Age of Asenapine Participants Aged 18 or Greater Initiating Asenapine During the First Year Since Drug Product Marketing in UK","time_frame":"Baseline observation period (minimum of at least 365 days prior to date of prescription)"},{"outcome_type":"primary","measure":"Gender of Asenapine Participants Aged 18 or Greater Initiating Asenapine During the First Year Since Drug Product Marketing in UK","time_frame":"Baseline observation period (minimum of at least 365 days prior to date of prescription)"},{"outcome_type":"primary","measure":"Frequency and Proportion of Pediatric Use, by Psychiatric Diagnosis","time_frame":"From baseline through 365 days after date of prescription"},{"outcome_type":"primary","measure":"Baseline Age of Asenapine Participants Less Than 18 Years Old Initiating Asenapine During the First Year Since Drug Product Marketing in UK","time_frame":"Baseline observation period (minimum of at least 365 days prior to date of prescription)"},{"outcome_type":"primary","measure":"Gender of Asenapine Participants Less Than 18 Years Old Initiating Asenapine During the First Year Since Drug Product Marketing in UK","time_frame":"Baseline observation period (minimum of at least 365 days prior to date of prescription)"}]}
{"nct_id":"NCT01797107","start_date":"2013-03-31","phase":"Phase 2","enrollment":0,"brief_title":"Study to Determine the Effect of Azasite on Corneal Surface Irregularity","official_title":"A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Effect of Azasite on Corneal Surface Irregularity in Subjects With Meibomian Gland Dysfunction","primary_completion_date":"2014-07-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2014-07-31","last_update":"2016-09-28","description":"The purpose of this study is to evaluate the effect of Azasite on patients with corneal surface irregularity (meibomian gland dysfunction).","other_id":"40958","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Ability to provide informed consent prior to enrollment in study\r\n\r\n          -  Patient ability to follow study instructions and comply with all study protocols\r\n\r\n          -  Corneal irregularity measurement (CIM) > 1.7 in both eyes\r\n\r\n          -  Non-atrophic meibomian gland dysfunction (MGD) as defined by abnormal meibomian\r\n             expression in at least 2 meibomian glands of the eyelids of each eye\r\n\r\n          -  At least two symptoms of at least moderate severity ( grade 2, 0 to 3 scale) as\r\n             defined in the MGD Global Symptom Score (Itching, Foreign-body sensation, Dryness,\r\n             Burning, Lid swelling)\r\n\r\n          -  Tear film break up time < 10 seconds\r\n\r\n          -  Schirmer with anesthesia > 5 mm\r\n\r\n          -  Best corrected distance visual acuity (BCDVA) > 20/100\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Cicatricial or atrophic meibomian gland dysfunction (MGD)\r\n\r\n          -  Any corneal disease or scar involving the central 6 mm, including epithelial basement\r\n             membrane dystrophy, Salzmann nodular degeneration, recurrent erosions, keratoconus or\r\n             ectasia\r\n\r\n          -  Use of azithromycin or doxycycline within 1 month of screening\r\n\r\n          -  Topical ocular antibiotic, anti-histamines, allergy, or steroid medication within 2\r\n             weeks of baseline (a 2 week washout after screening will be allowed)\r\n\r\n          -  Topical prostaglandin analogue use within 30 days of study\r\n\r\n          -  The anticipated use of any drops, gels or ointments during the study period outside of\r\n             the study protocol\r\n\r\n          -  Use of eye make-up during study period\r\n\r\n          -  Active ocular infection or inflammation\r\n\r\n          -  History of herpetic eye disease or neurotrophic keratitis\r\n\r\n          -  Lid pathology (except MGD or blepharitis) that the examiner feels may affect the\r\n             ocular surface\r\n\r\n          -  Significant conjunctival scars (ex. h/o SJS)\r\n\r\n          -  Pterygium\r\n\r\n          -  Lacrimal punctal occlusion within 2 months of screening\r\n\r\n          -  Ocular surgery within 1 year of screening\r\n\r\n          -  Monocular patients\r\n\r\n          -  Pregnant, breast-feeding, or sexually active females not using contraception\r\n\r\n          -  Uncontrolled systemic disease\r\n\r\n          -  Presence of any disease (medical or ocular) that, in the opinion of the investigator,\r\n             may interfere with the study's safety or interpretation\r\n\r\n          -  Known allergy to the study medication or its components\r\n\r\n          -  Current enrollment in an investigational drug or device study within 30 days of\r\n             screening for this study\r\n      ","sponsor":"Philadelphia Eye Associates","sponsor_type":"Other","conditions":"Meibomian Gland Dysfunction","interventions":[{"intervention_type":"Drug","name":"Drug: Azasite","description":"Patients will be given 1 drop twice a day for 2 days followed by 1 drop nightly for 4 weeks."}],"outcomes":[{"outcome_type":"secondary","measure":"Change in Corneal Irregularity Measurement","time_frame":"2 weeks, 6 weeks","description":"Topographically defined corneal smoothness as compared to baseline measurement at day 0"},{"outcome_type":"other","measure":"Tear film break-up time","time_frame":"2, 4 and 6 weeks","description":"Fluorescein break up time"},{"outcome_type":"primary","measure":"Change in Corneal Irregularity Measurement","time_frame":"4 weeks","description":"Topographically defined corneal smoothness as compared to baseline measurement at day 0"},{"outcome_type":"secondary","measure":"Global symptoms score","time_frame":"2,4 and 6 weeks","description":"0-3 score of itching, foreign body sensation, dryness, burning and swelling as compared to baseline measurement at day 0"},{"outcome_type":"secondary","measure":"Meibomian gland secretion characteristics","time_frame":"2, 4 and 6 weeks","description":"Meibum secretions of the eyelids will be assessed at each visit by pressing on the lower or upper lid (with a finger) until excretions are seen from at least 2 meibomian glands. The following scale, based on a scale in a study by Mathers et al (Mathers et al. Meibomian Gland Dysfunction in Chronic Blepharitis. Cornea .1991;10(4): 277-285.) will be used:\r\nNE= <2 glands expressible = Atrophic or Cicatricial MGD (exclusion at Visit 1 and 2) 0= clear secretion (normal)\r\nopaque secretion with normal viscosity\r\nopaque secretion with increased viscosity\r\nseverely thickened secretion, toothpaste consistency At each time point, these characteristics will be compared to baseline at day 0."},{"outcome_type":"secondary","measure":"Best corrected distance visual acuity","time_frame":"2, 4 and 6 weeks","description":"as compared to baseline measurement at day 0"},{"outcome_type":"secondary","measure":"Corneal staining","time_frame":"2, 4 and 6 weeks","description":"Using NEI industry workshop scale. Scores will be compared to baseline measurement at day 0"},{"outcome_type":"secondary","measure":"Axial topography based astigmatism pattern","time_frame":"2, 4 and 6 weeks","description":"Patterns will be compared to baseline at day 0. All topography testing will be performed using the same machine and system, the Carl Zeiss Meditec Atlas, Model 9000, system 3.0.0.39.\r\nThe topographic pattern will be reviewed by a masked investigator (masked to eye randomization), and categorized as one of the following:\r\nNormal/Symmetrical: Includes round, oval, or symmetric bowtie patterns\r\nAsymmetric bowtie: Differentiated from symmetric bowtie by a difference between axial keratometry readings along the two lobes of >1D at points 1.5mm from the center, or a difference in the widths of the lobes of the bowties at that distance of >33%.\r\nIrregular: Includes skewed radial axis (skewing by >20%), inferior or superior steepening (I-S asymmetry >1.2D); or a pattern that does not fit either 1 or 2 above."},{"outcome_type":"secondary","measure":"Intraocular Lens(IOL) Master Keratometry","time_frame":"2, 4 and 6 weeks","description":"As compared to baseline at day 0."}]}
{"nct_id":"NCT01532206","start_date":"2013-03-31","phase":"N/A","enrollment":1,"brief_title":"IL-10 Levels and Remote Ischemic Preconditioning in Acute Myocardial Infarction","official_title":"Interleukin-10 Levels and Remote Ischemic Preconditioning in Acute Myocardial Infarction.","primary_completion_date":"2014-02-28","study_type":"Interventional","rec_status":"Terminated","completion_date":"2014-05-31","last_update":"2016-03-25","description":"Remote ischemic preconditioning has proven beneficial in patients undergoing percutaneous coronary intervention and coronary artery bypass surgery. Animal studies suggest remote ischemic preconditioning increases levels of interleukin 10. The investigators aim to determine whether remote ischemic preconditioning results in an increase in IL-10 levels in patients following acute myocardial infarction.","other_id":"NA_00069912","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        - Acute myocardial infarction\r\n\r\n        Exclusion Criteria:\r\n\r\n        - Cardiogenic shock Active ischemia\r\n      ","sponsor":"Johns Hopkins University","sponsor_type":"Other","conditions":"Acute Myocardial Infarction","interventions":[{"intervention_type":"Other","name":"Other: Blood pressure cuff insufflation","description":"Blood pressure cuff will be inflated to a pressure of 200mmHg for 5 minutes. This will be repeated x 3, separated by 5 minutes."}],"outcomes":[{"outcome_type":"primary","measure":"Interleukin 10 levels","time_frame":"24 hours following RIPC"}]}
{"nct_id":"NCT01880294","start_date":"2013-03-31","enrollment":461,"brief_title":"A Study to Assess Different Diagnostic Criteria of Chronic Constipation in Asia","official_title":"CONSIST- Constipation Symptoms Observational Study: A Multicenter, Cross-Sectional Study to Assess Different Diagnostic Criteria of Chronic Constipation in Asia","primary_completion_date":"2013-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2013-12-31","last_update":"2015-02-09","description":"The purpose of the study is to evaluate the differences or similarities in the results obtained with two different scoring systems for chronic constipation in Asian participants consulting in gastroenterology clinics (the Asian Neurogastro-enterology and Motility Association (ANMA) chronic constipation (CC) diagnostic tool (diagnosis questionnaire) and the ROME III diagnosis criteria (western gold standard).","other_id":"CR100891","observational_model":"Cohort","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Asian participants diagnosed with chronic constipation using the Asian\r\n        Neurogastro-enterology and Motility Association diagnostic tool.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Participants who have at least 1 of the symptoms listed in the Screening Worksheet and\r\n             the symptom has been present for at least 3 months\r\n\r\n          -  Participants have signed the informed consent document indicating that they understand\r\n             the purpose of and procedures required for the study and are willing to complete all\r\n             the questions on the questionnaires\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Participants judged by the investigator to suffer from chronic constipation that is\r\n             drug-induced or with secondary causes eg, endocrine, metabolic or neurological\r\n             disorders, surgical obstruction, megacolon/megarectum, a diagnosis of\r\n             pseudo-obstruction and organic disorders of the large bowel\r\n\r\n          -  Pregnant female participants\r\n      ","sponsor":"Johnson & Johnson Pte Ltd","sponsor_type":"Industry","conditions":"Constipation","interventions":[{"intervention_type":"Drug","name":"Drug: No intervention","description":"Asian participants diagnosed with chronic constipation using ANMA diagnostic questionnaire will be observed."}],"outcomes":[{"outcome_type":"primary","measure":"The percentage of participants for whom the chronic constipation (CC) diagnosis, according to the Asian Neurogastro-enterology and Motility Association (ANMA) CC diagnostic tool, agrees with the CC diagnosis according to the ROME III diagnosis criteria","time_frame":"Day 1","description":"ANMA CC diagnostic criteria: hard stools; difficulty to pass stool; sensation of incomplete evacuation; less than 3 bowel movements per week; straining; sensation of anorectal obstruction; manual maneuvers; CC symptoms for the last 3 months with a symptom onset at least 3 months before diagnosis.\r\nROME III CC diagnosis criteria (any 2 or more): straining; lumpy or hard stools; sensation of incomplete evacuation; sensation of anorectal obstruction; manual maneuvers; less than 3 bowel movements per week; CC symptoms for the last 3 months with a symptom onset at least 6 months before diagnosis."},{"outcome_type":"primary","measure":"The percentage of participants for whom the CC diagnosis, according to the ANMA CC diagnostic tool, disagrees with the CC diagnosis according to the ROME III diagnosis criteria","time_frame":"Day 1"},{"outcome_type":"secondary","measure":"The percentage of participants with a diagnosis of CC according to the ROME III diagnosis criteria","time_frame":"Day 1","description":"Number of participants with CC diagnosed by ROME III divided by the number of Asian participants screened (at the gastroenterologist clinic)."},{"outcome_type":"secondary","measure":"The percentage of participants with a diagnosis of CC according to the ANMA CC diagnostic tool","time_frame":"Day 1","description":"Number of participants with CC diagnosed by ANMA divided by the number of Asian participants screened (at the gastroenterologist clinic)."},{"outcome_type":"secondary","measure":"The percentage of participants with a diagnosis of CC according to investigator judgement","time_frame":"Day 1","description":"Number of participants with CC diagnosed by investigator's judgement divided by the number of Asian participants screened (at the gastroenterologist clinic)."},{"outcome_type":"secondary","measure":"The percentage of participants with participant self-defined CC","time_frame":"Day 1","description":"Number of participants with self-defined CC divided by the number of Asian participants screened (at the gastroenterologist clinic)."},{"outcome_type":"secondary","measure":"The percentage of ROME-positive participants who need CC therapy","time_frame":"Day 1","description":"Number of participants with a positive ROME diagnosis who need CC therapy."},{"outcome_type":"secondary","measure":"The percentage of ROME-negative but ANMA positive participants who need CC therapy","time_frame":"Day 1","description":"Number of participants with a negative ROME diagnosis but positive ANMA diagnosis who need CC therapy."},{"outcome_type":"secondary","measure":"Participant assessment of current treatment as measured by the Constipation-Quality of Life (PAC-QOL) questionnaire","time_frame":"Day 1","description":"The PAC-QOL is a 28-item scale which includes 4 subscales: worries and concerns, physical discomfort, psychosocial discomfort, and satisfaction. Each item is rated on a 5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Total score ranges from 0 (best) to 112 (worst). Higher score indicates more impact on QOL."}]}
{"nct_id":"NCT01854541","start_date":"2013-03-31","enrollment":10000,"brief_title":"Visual Management for the Radiotherapy Process","official_title":"Visual Management for the Radiotherapy Process","primary_completion_date":"2015-01-31","study_type":"Observational [Patient Registry]","rec_status":"Completed","completion_date":"2015-01-31","last_update":"2015-04-10","description":"The Visual Management for Radiotherapy Practice (VMRTP) aims to analyze, predict, visualize and shorten the waiting times for radiotherapy patients. The hypothesis is that this can be done by the introduction of models that can predict a patient being at risk for waiting too long as well as visual management tools that visualize the radiotherapy process.","other_id":"VMRTP","observational_model":"Cohort","sampling_method":"Non-Probability Sample","gender":"All","population":"All patients treated with radiotherapy","criteria":"\n        Inclusion Criteria:\r\n\r\n        Patients receiving radiotherapy\r\n\r\n        Exclusion Criteria:\r\n\r\n        Patients not receiving radiotherapy\r\n      ","sponsor":"Maastricht Radiation Oncology","sponsor_type":"Other","conditions":"Cancer","interventions":{},"outcomes":[{"outcome_type":"secondary","measure":"intake and first day of radiotherapy","time_frame":"3 months","description":"Waiting time between intake and first day of radiotherapy"},{"outcome_type":"primary","measure":"referral and first day of radiotherapy","time_frame":"3 months","description":"Waiting time between referral and first day of radiotherapy"},{"outcome_type":"secondary","measure":"Diagnosis and first day of radiotherapy","time_frame":"3 months","description":"Waiting time between diagnosis and first day of radiotherapy"},{"outcome_type":"secondary","measure":"multi-disciplinary board and first day of radiotherapy","time_frame":"3 months","description":"Waiting time between multi-disciplinary board and first day of radiotherapy"},{"outcome_type":"secondary","measure":"simulation and first day of radiotherapy","time_frame":"3 months","description":"Waiting time between simulation and first day of radiotherapy"}]}
{"nct_id":"NCT01856283","start_date":"2013-03-31","phase":"Phase 2","enrollment":87,"brief_title":"Nilotinib 300 mg BID in Newly Diagnosed CP-CML Patients to Verify Disappearance of CD34+/Lin-Ph+ Cells","official_title":"An Open Label, Single Arm, Phase II Study of Nilotinib 300 mg BID in Newly Diagnosed CP-CML Patients, in Order to Verify Disappearance of CD34+/Lin-Ph+ Cells From Bone Marrow During Treatment","primary_completion_date":"2020-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2021-01-31","last_update":"2021-01-13","description":"This is a multicentre, single-arm study of nilotinib 300 mg BID in newly diagnosed patients with CP-CML. This study is designed to establish the disappearance of Ph+ stem cells (CD34+/lin-) in BM during nilotinib treatment. In addition, in this study the investigators aim to perform Gene Expression Profiling (GEP) of CML enrolled patients using Affymetrix GeneChip Instruments and Software Systems, and Affymetrix GeneChip Human Genome U133 Plus 2.0 (whole human transcriptome analysis) at diagnosis and at 3 different time points during treatment with Nilotinib (after 3, 6, 12 months).","other_id":"PhilosoPhy34 CAMN107EIT11T","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female patients with diagnosis of CP-CML with cytogenetic confirmation of Ph\r\n             chromosome (9;22) translocation within 3 months of diagnosis\r\n\r\n          -  Patients Ph negative or with variant translocations by standard cytogenetic analysis\r\n             but Ph positive by FISH, are eligible as well\r\n\r\n          -  Age  18 years old (no upper age limit given)\r\n\r\n          -  WHO performance status 2\r\n\r\n          -  Normal serum levels  LLN (lower limit of normal) of potassium, magnesium, total\r\n             calcium corrected for serum albumin or phosphorus, or correctable to within normal\r\n             limits with supplements, prior to the first dose of study medication\r\n\r\n          -  AST and ALT  2.5 x ULN or  5.0 x ULN if considered due to leukaemia\r\n\r\n          -  Alkaline phosphatase  2.5 x ULN unless considered due to leukaemia\r\n\r\n          -  Total bilirubin  1.5 x ULN, except know Mb Gilbert\r\n\r\n          -  Serum lipase and amylase  1.5 x ULN\r\n\r\n          -  Serum creatinine  1.5 x ULN\r\n\r\n          -  Written informed consent signed prior to any study procedures being performed\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pre-treatment with HU for > 3 months and with imatinib is not permitted\r\n\r\n          -  Prior accelerated phase including clonal evolution or blast crisis\r\n\r\n          -  Contraindication to excipients in study medication\r\n\r\n          -  impaired cardiac function including any of the following:\r\n\r\n               1. LVEF <45%\r\n\r\n               2. Complete left bundle branch block\r\n\r\n               3. Right bundle branch block plus left anterior hemiblock,bifascicular block\r\n\r\n               4. Use of a ventricular-paced pacemaker\r\n\r\n               5. Congenital long QT syndrome\r\n\r\n               6. Clinically significant ventricular or atrial tachyarrhythmias\r\n\r\n               7. Clinically significant resting bradycardia (<50 beats per minute)\r\n\r\n               8. QTcF >450 msec on screening ECG.If QTcF >450 msec and electrolytes are not within\r\n                  normal ranges before nilotinib dosing, electrolytes should be corrected and then\r\n                  the patient rescreened for QTcF criterion\r\n\r\n               9. Myocardial infarction within 12 months prior to starting nilotinib\r\n\r\n              10. Other clinical significant heart disease (e.g. unstable angina,congestive heart\r\n                  failure,uncontrolled hypertension)\r\n\r\n          -  Acute (i.e. within 1 year of starting study medication) or chronic pancreatitis\r\n\r\n          -  Concurrent uncontrolled medical conditions (e.g. uncontrolled diabetes, active or\r\n             uncontrolled infections,acute or chronic liver and renal disease) that could cause\r\n             unacceptable safety risks or compromise compliance with the protocol\r\n\r\n          -  Impaired gastrointestinal function or disease that may alter the absorption of study\r\n             drug (e.g.ulcerative disease,uncontrolled nausea,vomiting and diarrhea,malabsorption\r\n             syndrome,small bowel resection or gastric by-pass surgery)\r\n\r\n          -  Concomitant medications with potential QT prolongation (see link for complete list:\r\n             http://www.torsades.org/medical-pros/drug-lists/printable-drug-list.cfm)\r\n\r\n          -  Concomitant medications known to be strong inducers or inhibitors of the CYP450\r\n             Isoenzyme CYP3A4:see link for complete list\r\n             (http://medicine.iupui.edu/flockhart/table.htm)\r\n\r\n          -  Patients who have undergone major surgery  2 weeks prior to starting study drug or\r\n             who have not recovered from side effects of such therapy\r\n\r\n          -  Patients who are pregnant or breast feeding or women of reproductive potential not\r\n             employing an effective method of birth control.Women of childbearing potential must\r\n             have a negative serum pregnancy test within 14 days prior to administration of\r\n             nilotinib.Post menopausal women must be amenorrheic for at least 12 months in order to\r\n             be considered of non-childbearing potential.Female patients must agree to employ an\r\n             effective barrier method of birth control throughout the study and for up to 3 months\r\n             following discontinuation of study drug\r\n\r\n          -  Treatment with any haematopoietic colony-stimulating growth factors (e.g. G-CSF,\r\n             GM-CSF) 1 week prior to starting study drug\r\n\r\n          -  Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not\r\n             mandatory)\r\n\r\n          -  Patients with a history of another primary malignancy that is currently clinically\r\n             significant or currently requires active intervention\r\n\r\n          -  Patients unwilling or unable to comply with the protocol\r\n      ","sponsor":"Niguarda Hospital","sponsor_type":"Other","conditions":"Leukemia, Myeloid, Chronic-Phase","interventions":[{"intervention_type":"Drug","name":"Drug: Nilotinib 300mg BID","description":"Nilotinib"}],"outcomes":[{"outcome_type":"primary","measure":"CD34+/lin-Ph+ cells","time_frame":"6 month","description":"To measure the rate of CD34+/lin-Ph+ cells in the BM after 6 months of treatment. In order to obtain this result, BM blood of all enrolled patients (see Appendix\r\n1) will be stored after 6 months of treatment with nilotinib. The isolated CD34+/lin- cells will be employed for standard FISH analysis."},{"outcome_type":"secondary","measure":"CD34+/lin- cells (composite measure)","time_frame":"12 month","description":"Secondary endpoints will be reached performing:\r\nthe same analyzes on CD34+/lin- cells at diagnosis, at 3 and 12 months of treatment;\r\ncytogenetic analysis to estimate the rate of CCyR at 3, 6 and 12 months; this analysis will be performed at each local laboratory; molecular analysis to determinate the rate of MR (≤ 10%, ≤ 1%, MMR, MR4,5 IS) at 3, 6 and 12 months in the peripheral blood; the molecular analysis will be performed using the Labnet standardized laboratories in Lombardy.\r\nThe Outcome Measure indicates that the measure is a composite."}]}
{"nct_id":"NCT01824043","start_date":"2013-03-31","phase":"Phase 4","enrollment":20,"brief_title":"Use of Intravitreal Ranibizumab in the Treatment of Vitreous Hemorrhage","official_title":"Pilot Study Investigating the Use of Intravitreal Ranibizumab in the Treatment of Vitreous Hemorrhage in Proliferative Diabetic Retinopathy","primary_completion_date":"2013-09-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2013-12-31","last_update":"2013-04-04","description":"Primary Objective: To investigate the effectiveness of intravitreal applications of 0.5 mg Lucentis (ranibizumab) in patients with vitreous hemorrhage due to proliferative diabetic retinopathy. The primary endpoint for the study will be the mean change in best-corrected visual acuity (BCVA) from baseline to the mean level at Month 3. Secondary Objectives: 1. To assess any differences in mean change in BCVA over time; 2. To assess differences in vitreous transparency (amount of hemorrhage) with fundus angiography exam; 3. To assess any differences in retinopathy severity level according to the Early Treatment Diabetic Retinopathy Study; 4. To correlate the visual outcomes with serum glucose levels.","other_id":"LUBRAHV","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female patients >18 years of age who have signed an informed consent\r\n\r\n          -  Patients with Type 1 or Type 2 diabetes mellitus (according to ADA or WHO guidelines).\r\n\r\n          -  Patients with visual impairment due to vitreous hemorrhage.\r\n\r\n          -  Medication for the management of diabetes must have been stable within 3 months prior\r\n             to randomization and is expected to remain stable during the course of the study.\r\n\r\n        Exclusion criteria:\r\n\r\n        Ocular concomitant conditions/ diseases\r\n\r\n          -  Concomitant conditions in the study eye which could, in the opinion of the\r\n             investigator, prevent the improvement of visual acuity on study treatment\r\n\r\n          -  Active intraocular inflammation (grade trace or above) in either eye\r\n\r\n          -  Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis,\r\n             endophthalmitis) in either eye\r\n\r\n          -  History of uveitis in either eye\r\n\r\n          -  Ocular disorders in the study eye that may confound interpretation of study results,\r\n             compromise visual acuity or require medical or surgical intervention during the\r\n             12-month study period, including retinal vascular occlusion, retinal detachment,\r\n             macular hole, or choroidal neovascularization of any cause (e.g., age-related macular\r\n             degeneration, ocular histoplasmosis, or pathologic myopia)\r\n\r\n          -  Uncontrolled glaucoma in the study eye (according to investigator's judgment)\r\n\r\n          -  Neovascularization of the iris in study eye\r\n\r\n          -  Evidence of vitreomacular traction in study eye\r\n\r\n        Ocular treatments\r\n\r\n          -  Panretinal laser photocoagulation in the study eye within 6 months or focal/grid laser\r\n             photocoagulation in the study eye within 3 months prior to study entry\r\n\r\n          -  Treatment with anti-angiogenic drugs (pegaptanib sodium, anecortave acetate,\r\n             bevacizumab, ranibizumab, etc.) or intravitreal corticosteroids in either eye within 4\r\n             months prior to randomization\r\n\r\n          -  Any intraocular surgery in the study eye within 3 months prior to randomization\r\n\r\n          -  History of vitrectomy in study eye\r\n\r\n          -  Phakic study eye with a history of intravitreal corticosteroid treatment\r\n\r\n          -  Ocular conditions in the study eye that require chronic concomitant therapy with\r\n             topical ocular or systemically administered corticosteroids\r\n\r\n        Systemic conditions or treatments\r\n\r\n          -  History of disease, metabolic dysfunction, physical examination finding, or clinical\r\n             laboratory finding giving reasonable suspicion of a disease or condition that\r\n             contraindicates the use of an investigational drug, might affect the interpretation of\r\n             the results of the study, or renders the patient at high risk from treatment\r\n             complications\r\n\r\n          -  Renal failure requiring dialysis or renal transplant OR renal insufficiency with\r\n             creatinine levels >2.0 mg/dl\r\n\r\n          -  Untreated diabetes mellitus\r\n\r\n          -  Severe (blood pressure systolic > 160 mmHg OR diastolic > 100 mmHg) AND untreated\r\n             hypertension\r\n\r\n          -  Current use of or likely need for systemic medications known to be toxic to the lens,\r\n             retina or optic nerve, including Deferoxamine, Chloroquine/ hydroxychloroquine\r\n             (Plaquenil), Tamoxifen, Phenothiazines and Ethambutol\r\n\r\n          -  Known hypersensitivity to ranibizumab or any component of the ranibizumab formulation\r\n             or to fluorescein contrast.\r\n\r\n        Compliance/ Administrative\r\n\r\n          -  Previous participation in any clinical studies of investigational drugs (excluding\r\n             vitamins and minerals) within 1 month (or a period corresponding to 5 half-lives of\r\n             the investigational drug, whatever is longer) prior to randomization\r\n\r\n          -  Women of child-bearing potential, defined as all women physiologically capable of\r\n             becoming pregnant, including women whose career, lifestyle, or sexual orientation\r\n             precludes intercourse with a male partner and women whose partners have been\r\n             sterilized by vasectomy or other means, UNLESS they are using two birth control\r\n             methods. The two methods can be a double barrier method or a barrier method plus a\r\n             hormonal method. Adequate barrier methods of contraception include: diaphragm, condom\r\n             (by the partner), intrauterine device (copper or hormonal), sponge or spermicide.\r\n             Hormonal contraceptives include any marketed contraceptive agent that includes an\r\n             estrogen and/or a progestational agent.\r\n\r\n          -  Pregnant or nursing (lactating) women.\r\n\r\n          -  Inability to comply with study or follow-up procedures.\r\n      ","sponsor":"Hospital Regional de So Jos - Dr. Homero de Miranda Gomes","sponsor_type":"Other","conditions":"Diabetic Retinopathy|Vitreous Hemorrhage","interventions":[{"intervention_type":"Drug","name":"Drug: intravitreal ranibizumab injections","description":"Patients will be treated monthly: intravitreal ranibizumab (0.5 mg) will be administered in an open-label fashion, using 3 monthly injections (at day 0, day 30 and day 60) followed by an additional post treatment visit, a month after the last injection, for posterior reports"}],"outcomes":[{"outcome_type":"primary","measure":"Gain in visual acuity and transparence of vitreous in treated eyes.","time_frame":"90 days"},{"outcome_type":"other","measure":"Visual acuity improvement measured by Snellen chart","time_frame":"90 days"},{"outcome_type":"other","measure":"Reduction in the ETDRS diabetic retinopathy severity level","time_frame":"90 days"},{"outcome_type":"other","measure":"Serum glucose levels will be compared with the visual outcomes","time_frame":"90 days","description":"It is expected that low glucose levels helps in better visual outcomes."}]}
{"nct_id":"NCT01927458","start_date":"2013-03-31","phase":"N/A","enrollment":6,"brief_title":"Transcranial Direct Current Stimulation Aided Rehabilitation of Gait in Subacute Stroke","primary_completion_date":"2015-12-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2015-12-31","last_update":"2017-02-07","description":"The purpose of this study is to determine if transcranial direct current stimulation (tDCS)applied over the lower extremity motor cortex in conjunction with treadmill training is effective for improving gait in patients with subacute stroke and to evaluate the effect and predictive value of a single session of anodal tDCS.","other_id":"M-2012-570-12","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age  18 years\r\n\r\n          -  Onset of stroke less than 14 days\r\n\r\n          -  First ischemic stroke causing lower limb weakness (MRC score 4 in knee extensors) and\r\n             gait impairment\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Contraindications to MRI or TMS\r\n\r\n          -  Other neurological disorders\r\n\r\n          -  Significant somatic or psychiatric disorders\r\n\r\n          -  History of seizures\r\n\r\n          -  Language or cognitive disorders prohibiting participation\r\n      ","sponsor":"University of Aarhus","sponsor_type":"Other","conditions":"Stroke|Neurorehabilitation","interventions":[{"intervention_type":"Device","name":"Device: Transcranial Direct Current Stimulation","description":"A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue"}],"outcomes":[{"outcome_type":"primary","measure":"Maximal gait speed using the 10-m walking test","time_frame":"Baseline and follow up immediately following the 4 weeks intervention"},{"outcome_type":"secondary","measure":"Changes in cortical excitability measures","time_frame":"Baseline","description":"We will measure cortical excitability using single pulse transcranial magnetic stimulation (TMS) before and after 1st stimulation session. We will compare the measurements from before stimulation to after stimulation."},{"outcome_type":"secondary","measure":"Dynamometry: the maximal isometric force of muscles will be assessed by Biodex System 3 PRO dynamometer","time_frame":"Baseline and immediately following the 4 weeks intervention"}]}
{"nct_id":"NCT02087930","start_date":"2013-03-31","enrollment":600,"brief_title":"Microbiota as Potential Target for Food Allergy","official_title":"Microbiota as Potential Target for Innovative Preventive and Therapeutic Strategies for Food Allergy","primary_completion_date":"2020-05-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2020-09-30","last_update":"2018-05-29","description":"Food allergy (FA) derives from a dysregulation of oral tolerance mechanisms. Studies suggest a crucial role for enteric microflora in oral tolerance development. An altered composition of intestinal microflora results in an unbalanced local and systemic immune response to food allergens. There are qualitative and quantitative differences in gut microbiota composition in children with food allergy. These findings support the concept that specific beneficial bacteria from human intestinal microflora, designated probiotics, could restore intestinal microflora homeostasis and prevent or treat FA.","other_id":"02/14","sampling_method":"","gender":"All","minimum_age":0.5,"maximum_age":1,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  children with cow's milk allergy\r\n\r\n          -  age 6-12 months\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  concomitant chronic systemic diseases\r\n\r\n          -  congenital cardiac defects\r\n\r\n          -  active tuberculosis\r\n\r\n          -  autoimmune diseases\r\n\r\n          -  immunodeficiency\r\n\r\n          -  chronic inflammatory bowel diseases\r\n\r\n          -  celiac disease, cystic fibrosis\r\n\r\n          -  metabolic diseases\r\n\r\n          -  malignancy\r\n\r\n          -  chronic pulmonary diseases\r\n\r\n          -  malformations of the gastrointestinal tract\r\n\r\n          -  suspected eosinophilic esophagitis or eosinophilic enterocolitis\r\n\r\n          -  suspected food-protein-induced enterocolitis syndrome.\r\n      ","sponsor":"Federico II University","sponsor_type":"Other","conditions":"Cow Milk Allergy","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Composition and function gut microbiota in children with cow milk allergy and healthy children","time_frame":"Change from baseline at 6 and 12 months"},{"outcome_type":"secondary","measure":"Composition and function gut microbiota comparing cow milk allergy Italian and cow milk allergy children of other countries","time_frame":"Change from baseline at 6 and 12 months"},{"outcome_type":"secondary","measure":"Composition and function gut microbiota comparing healthy Italian and healthy children of other countries","time_frame":"Change from baseline at 6 and 12 months"}]}
{"nct_id":"NCT02460614","start_date":"2013-03-31","phase":"N/A","enrollment":100,"brief_title":"Effects of Rhinopharyngeal Retrograde Clearance in Children With Acute Viral Bronchiolitis","official_title":"Comparison Between Rhinopharyngeal Retrograde Clearance and Nasopharyngeal Aspiration in Children With Acute Viral Bronchiolitis","primary_completion_date":"2013-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-12-31","last_update":"2015-06-03","description":"The purpose of this study is to compare the immediate effects of retrograde rhinopharyngeal clearance with nasopharyngeal aspiration in children admitted with acute viral bronchiolitis. The investigators selected children, up to 12 months old, admitted for acute viral bronchiolitis. Patients were divided in aspiration group (AG), submitted to nasopharyngeal aspiration, and clearance group (CG), submitted to retrograde rhinopharyngeal clearance with physiological solution (0.9%) instillation (RRC) technique. In both groups children were evaluated three times in the same day in order to verify cardiorespiratory parameters, clinical score of respiratory dysfunction and adverse effects.","other_id":"DRR-15","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","maximum_age":1,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  acute viral bronchiolitis diagnosis\r\n\r\n          -  indication for hospital admission\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  history of lung disease related to prematurity (bronchopulmonary dysplasia)\r\n\r\n          -  heart diseases\r\n\r\n          -  chronic lung diseases (cystic fibrosis)\r\n\r\n          -  pneumonia\r\n\r\n          -  unstable hemodynamic process (ARDS or sepsis)\r\n\r\n          -  subcutaneous edema\r\n\r\n          -  admission to the intensive care unit\r\n\r\n          -  need for mechanical ventilation or tracheostomy\r\n\r\n          -  neurological diseases\r\n      ","sponsor":"Pontificia Universidade Catlica do Rio Grande do Sul","sponsor_type":"Other","conditions":"Acute Viral Bronchiolitis","interventions":[{"intervention_type":"Other","name":"Other: 0.9% saline","description":"0.9% saline consists of physiological solution and was instilled in both experimental groups."},{"intervention_type":"Procedure","name":"Procedure: Rhinopharyngeal clearance","description":"At the end of the expiratory time, the child's mouth was closed by the hand of the researcher (raising the lower jaw), leading the child to perform a nasal aspiration maneuver."},{"intervention_type":"Procedure","name":"Procedure: Aspiration","description":"A sterile aspiration catheter was connected to an extension and carefully introduced into the nasal cavity of the patient."}],"outcomes":[{"outcome_type":"primary","measure":"Occurrence of chest retractions as a measure of respiratory distress","time_frame":"30 minutes"},{"outcome_type":"primary","measure":"Occurrence of wheezing as a measure of respiratory distress","time_frame":"30 minutes"},{"outcome_type":"primary","measure":"Number of nasal bleeding events as a measure of adverse effects","time_frame":"1 day"},{"outcome_type":"primary","measure":"Number of vomit episodes as a measure of adverse effects","time_frame":"1 day"},{"outcome_type":"secondary","measure":"Measurement of the heart rate using an oximeter","time_frame":"30 minutes"},{"outcome_type":"secondary","measure":"Measurement of the respiratory rate","time_frame":"30 minutes"},{"outcome_type":"secondary","measure":"Measurement of the oxygen saturation using an oximeter","time_frame":"30 minutes"},{"outcome_type":"secondary","measure":"Severity scores on the Wood clinical score","time_frame":"30 minutes"}]}
{"nct_id":"NCT02426255","start_date":"2013-03-29","enrollment":5000,"brief_title":"Post Traumatic Critical Complications: a Prospective Cohort Study (ATLANREA)","official_title":"Prospective Cohort of Severe Trauma Patients Hospitalized in West French Intensive Care Units","primary_completion_date":"2050-01-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2050-01-31","last_update":"2020-06-04","description":"The purpose of this observational epidemiological study is to investigate the management and the complications associated with severe trauma. Data will be analysed to answer pre-defined scientific projects and to improve management of these conditions.","other_id":"RC12_0207 cohorte fiche 2","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":15,"population":"Patients hospitalized in ICU for severe trauma","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  severe trauma\r\n\r\n          -  and/or traumatic brain injury\r\n\r\n          -  and/or hemorrhage\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Consent withdrawal\r\n      ","sponsor":"Nantes University Hospital","sponsor_type":"Other","conditions":"Severe Trauma (With or Without Traumatic Brain Injury)","interventions":[{"intervention_type":"Other","name":"Other: Collection of medical data from ICU patients","description":"A code will be applied to each patient included. Medical data such as demography, Simplified Acute Physiological Score II (SAPS II), Sequential Organ Failure Assessment (SOFA), procedures and complications during ICU stay will be collected."}],"outcomes":[{"outcome_type":"primary","measure":"in ICU stay complications","time_frame":"Within the 28 first days after ICU admission date","description":"Nosocomial Infections (epidemiology, risk factors, antibiotic susceptibility of pathogens) Organ failures (incidence, risk factors) Bleeding, hemorrhage Intra-cranial hypertension, brain ischemia Mechanical ventilation weaning, extubation failure"},{"outcome_type":"secondary","measure":"Duration of mechanical ventilation","time_frame":"in ICU (up to 90 days)"},{"outcome_type":"secondary","measure":"ICU length of stay","time_frame":"in ICU (up to 90 days)"},{"outcome_type":"other","measure":"Death","time_frame":"in ICU (up to 90 days)"}]}
{"nct_id":"NCT01867463","start_date":"2013-03-27","phase":"Phase 1","enrollment":230,"brief_title":"Testing Pfs25-EPA/Alhydrogel as a Potential Malaria Transmission Blocking Vaccine","official_title":"Double Blind Dose-Escalating Randomized Controlled Phase 1 Study in Malaria Exposed Adults of the Safety and Immunogenicity of Pfs25-EPA/ Alhydrogel, a Transmission Blocking Vaccine Against Plasmodium Falciparum in Bancoumana, Mali","primary_completion_date":"2015-12-22","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-12-19","last_update":"2018-07-05","description":"Background: - Malaria is a disease that is spread by mosquitoes. Researchers are looking for a vaccine that can prevent mosquitoes from transmitting malaria to people. They want to test a vaccine called Pfs25-EPA/Alhydrogel that may help stop malaria parasites from developing in mosquitoes. When a mosquito bites a vaccinated person, the vaccine should prevent parasites from developing in the mosquito. As a result, the mosquito will not spread malaria to the next person it bites. However, the vaccine will not directly prevent people vaccinated from getting sick with malaria. Researchers want to test this vaccine in people who live in rural Mali. To do so, the study will compare the symptoms and the blood tests of the participants who receive either the study vaccine or a regular hepatitis B/meningococcal vaccine. Objectives: - To see if Pfs25-EPA/Alhydrogel is a safe and effective malaria vaccine. Eligibility: - Healthy volunteers between 18 and 45 years of age who live in Bancoumana, Mali. Design: - Participants will be screened with a medical history, physical exam, and blood tests. - Participants will be separated into two groups. One group will have Pfs25-EPA/Alhydrogel to test the study vaccine. The other group will have the regular Hepatitis B vaccine series, meningococcal vaccine. - In the study vaccine group, participants will have either a lower dose or a higher dose. For the lower dose, they will have two vaccine shots over 1 year. For the higher dose, they will have four vaccine shots over about 14 months. - In the other vaccine group, participants will have the Hepatitis B vaccine series, meningococcal vaccine according to the standard dose schedule. - All participants will provide regular blood samples for testing during the study. - Participants who develop malaria during the study will participate in evaluation of transmission and parasite development of malaria parasite from the person to mosquito via transmission assays. They will allow mosquitoes (that have no diseases) to bite them in a controlled clinic setting. This will let researchers see if the vaccine can stop the mosquitoes from carrying malaria to other people.","other_id":"999913109","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        -  INCLUSION CRITERIA:\r\n\r\n        All of the following criteria must be fulfilled for a subject to participate in this trial:\r\n\r\n          1. Adult age 18 45 years.\r\n\r\n          2. Known residents of the village of Bancoumana or immediate surrounding areas.\r\n\r\n          3. Available for the duration of the trial (approximately 2.5 years).\r\n\r\n          4. Good general health as a result of review of medical history and/or clinical testing\r\n             at the time of screening.\r\n\r\n          5. Willingness to participate in the study as evidenced by signing the informed consent\r\n             document, or by fingerprinting the consent document with the signature of a witness.\r\n\r\n          6. Willingness to undergo a HIV test.\r\n\r\n          7. Willingness to undergo direct skin feeds.\r\n\r\n        EXCLUSION CRITERIA:\r\n\r\n        A subject will be excluded from participating in this trial if any one of the following\r\n        criteria is fulfilled:\r\n\r\n          1. Pregnancy, as determined by a positive urine or serum human choriogonadotropin (beta\r\n             human chorionic gonadotropin ) test at any point during the study (if female).\r\n\r\n          2. Currently lactating and breast-feeding (if female).\r\n\r\n          3. Unable or unwilling to use reliable contraception for a minimum of one month prior to\r\n             the first vaccination to three months after the last vaccination (if female). Reliable\r\n             birth control includes: pharmacologic contraceptives including oral, parenteral, and\r\n             transcutaneous delivery; condoms with spermicide; diaphragm with spermicide; surgical\r\n             sterilization; vaginal ring; transdermal patch; intrauterine device; abstinence; and\r\n             postmenopause.\r\n\r\n             (Note: If screening of the female subject occurs < 1 month prior to first vaccination,\r\n             a negative serum pregnancy test at time of screening and at enrollment (first\r\n             vaccination) and agreement to use of reliable contraception for the duration of the\r\n             study until three months after the fourth vaccination is acceptable.)\r\n\r\n          4. Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator\r\n             affects the ability of the participant to understand and cooperate with the study\r\n             protocol.\r\n\r\n          5. Hemoglobin, WBC, and platelets outside the local laboratory-defined upper limit of\r\n             normal (subjects may be included at the investigator s discretion for not clinically\r\n             significant values outside of normal range).\r\n\r\n          6. Neutropenia (absolute neutrophil count <1250/mm3).\r\n\r\n          7. Alanine transaminase (ALT) or creatinine (Cr) level above the local laboratory-defined\r\n             upper limit of normal.\r\n\r\n          8. Positive test for hepatitis C virus (HCV).\r\n\r\n          9. Positive test for hepatitis B (HBsAg).\r\n\r\n         10. Positive test for human immunodeficiency virus (HIV).\r\n\r\n         11. Known immunodeficiency syndrome.\r\n\r\n         12. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine,\r\n             rheumatologic, autoimmune, hematological, or renal disease by history, physical\r\n             examination, and/or laboratory studies including urinalysis.\r\n\r\n         13. Subject has had medical, occupational, or family problems as a result of alcohol or\r\n             illicit drug use during the past 12 months.\r\n\r\n         14. History of a severe allergic reaction or anaphylaxis.\r\n\r\n         15. History of a severe reaction to mosquito bites.\r\n\r\n         16. Severe asthma, defined as asthma that is unstable or required emergent care, urgent\r\n             care, hospitalization or intubation during the past 2 years, or that has required the\r\n             use of oral or parenteral corticosteroids at any time during the past 2 years.\r\n\r\n         17. Clinically significant reactive airway disease that does not respond to\r\n             bronchodilators.\r\n\r\n         18. History of a surgical splenectomy.\r\n\r\n         19. Use of chronic (greater than or equal to 14 days) oral or intravenous corticosteroids\r\n             (excluding topical or nasal) at immunosuppressive doses (i.e., prednisone >10 mg/ day)\r\n             or immunosuppressive drugs within 30 days of starting this study.\r\n\r\n         20. Receipt of a live vaccine within past four weeks or a killed vaccine within past two\r\n             weeks prior to entry into the study.\r\n\r\n         21. Receipt of blood products within the past 6 months.\r\n\r\n         22. Previous participation in a malaria vaccine trial.\r\n\r\n         23. History of receiving any investigational product within the past 30 days.\r\n\r\n         24. Refusal to allow storage of samples for future research at the time of enrollment.\r\n\r\n         25. Any medical, psychiatric, social, or occupational condition that, in the judgment of\r\n             the Principal Investigator (PI), would interfere with the evaluation of study\r\n             objectives or increase risk to the subject.\r\n      ","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","sponsor_type":"NIH","conditions":"Malaria","interventions":[{"intervention_type":"Biological","name":"Biological: Pfs25-EPA/Alhydrogel","description":"The Pfs25-EPA conjugate was produced by reaction between thiolated PpPfs25 and maleimideactivated EcEPA, followed by purification using size-exclusion chromatography. The cGMP Pfs25-EPA conjugate Lot# WRAIR1634 was manufactured at Walter Reed Bioproduction facility in cGMP compliance in May 2010. Alhydrogel (Brenntag, Denmark) is an aluminum hydroxide gel and has been extensively used as an adjuvant in licensed human vaccines. Alhydrogel is supplied as a sterile product in water without preservatives. Pfs25- EPA/Alhydrogel WRAIR Lot #1668 was manufactured and filled as single-use vials at Walter Reed Bioproduction facility in cGMP compliance in October 2010. Each vial contains 78 g/mL conjugated Pfs25, 93 g/mL conjugated EPA and 1600 g/mL Alhydrogel in a volume of 0.8 mL. The vial label reads: 78 g/mL Conjugated Pfs25 on Alhydrogel ."},{"intervention_type":"Biological","name":"Biological: Euvax B","description":"Euvax B consists of highly purified, noninfectious particles of HBsAg absorbed onto aluminum salts as an adjuvant and preserved with thimerosal."},{"intervention_type":"Biological","name":"Biological: Menactra","description":"Menactra , Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine, is a sterile, intramuscularly administered vaccine that contains Neisseria meningitidis serogroup A, C, Y and W-135 capsular polysaccharide antigens individually conjugated to diphtheria toxoid protein. N meningitidis A, C, Y and W-135 strains are cultured on Mueller Hinton agar (3) and grown in Watson Scherp (4) media. The polysaccharides are extracted from the N meningitidis cells and purified by centrifugation, detergent precipitation, alcohol precipitation, solvent extraction and diafiltration."}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of local and systemic adverse events and serious adverse events.","time_frame":"12 months following the last vaccination; and for 6 months following the fourth vaccination."},{"outcome_type":"secondary","measure":"Antibody responses as measured by ELISA against recombinant Pfs25 and EPA, and B cell responses. Functional activity of the induced antibody will be assessed by direct transmission blocking assays","time_frame":"12 months following the last vaccination; and for 6 months following the fourth vaccination."}]}
{"nct_id":"NCT01776814","start_date":"2013-02-28","enrollment":100,"brief_title":"Comparison of the Efficacy of Entecavir and Tenofovir Monotherapy for the Treatment of Nucleos(t)Ide-nave Patients With Chronic Hepatitis B in Korea","primary_completion_date":"2013-02-28","study_type":"Observational","rec_status":"Unknown status","last_update":"2013-01-28","description":"Chronic hepatitis B virus infection is an important cause of morbidity and mortality. Tenofovir disoproxil fumarate and entecavir were licensed for the treatment of hepatitis B virus infection. In this study, the investigators will try to make comparison between Entecavir and Tenofovir and investigate the efficacy.","other_id":"GAIRB2963-2012","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":70,"population":"treatment of nucleos(t)ide-naive patients who were diagnosed with chronic hepatitis B in\r\n        Korea","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18 < Age < 70\r\n\r\n          -  HBV DNA > 100,000 copies/mL and increased ALT over 2 times compared with normal range\r\n             if HBsAg (+), HBeAg (+)\r\n\r\n          -  HBV DNA > 10,000 copies/mL and increased ALT compared with normal range if HBsAg (+),\r\n             HBeAg (-)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  With HCV or other liver disease\r\n\r\n          -  With kidney disease\r\n\r\n          -  decompensated liver cirrhosis\r\n\r\n          -  with hepatocellular carcinoma\r\n\r\n          -  refuse this clinical trials\r\n      ","sponsor":"Gachon University Gil Medical Center","sponsor_type":"Other","conditions":"Chronic Hepatitis B","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"virologic response","time_frame":"changes from baseline HBV DNA level at 3, 6, 9, 12 months after taking entecavir or tenofovir","description":"Patients will check the HBV DNA level at 3, 6, 9, 12 months after taking entecavir and tenofovir"},{"outcome_type":"secondary","measure":"reduction of alanine transaminase","time_frame":"changes from baseline ALT level at 3,6,9,12 months after taking entecavir or tenofovir","description":"Patients will check the level of alanine transaminasel at 3, 6, 9, 12 months after taking entecavir and tenofovir"}]}
{"nct_id":"NCT01718574","start_date":"2013-02-28","phase":"N/A","enrollment":89,"brief_title":"Bibliotherapy for Patients With Cancer","official_title":"Feasibility, Acceptability and Efficacy of Bibliotherapy for Patients With Cancer: a Randomized Control Trial","primary_completion_date":"2014-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-09-30","last_update":"2014-09-09","description":"The purpose of this study is to examine the efficacy of a self-help workbook in enhancing a sense of empowerment, coping, quality of life and reducing distress for patients with cancer.","other_id":"2888","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18+ years of age\r\n\r\n          -  been diagnosed with cancer\r\n\r\n          -  can read English\r\n\r\n        Exclusion Criteria:\r\n\r\n        -participating in the \"Think Smart, Live Well\" group\r\n      ","sponsor":"McGill University Health Centre/Research Institute of the McGill University Health Centre","sponsor_type":"Other","conditions":"Cancer","interventions":[{"intervention_type":"Other","name":"Other: Self-help book","description":"Participants have 6 weeks to complete a 12 chapter self-help workbook. The workbook addresses: (i) The enhancement of a sense of personal control; and (ii) The learning of emotional and instrumental coping responses"}],"outcomes":[{"outcome_type":"primary","measure":"change in Health Education Impact Questionnaire scores","time_frame":"pre-intervention (week 0), post intervention (week 6), follow-up (week 10)"},{"outcome_type":"secondary","measure":"change in Ways of Coping Questionnaire - Cancer Version & Hospital Anxiety and Depression Scale scores","time_frame":"pre-intervention (week 0), post intervention (week 6), follow-up (week 10)"}]}
{"nct_id":"NCT02201043","start_date":"2013-02-28","phase":"Phase 2","enrollment":197,"brief_title":"Phase II Clinical Study of Thalidomide in the Treatment of Ankylosing Spondylitis","official_title":"A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Study of Thalidomide in the Treatment of Ankylosing Spondylitis","primary_completion_date":"2015-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-02-28","last_update":"2015-11-20","description":"1. Evaluate the efficacy and safety of taking thalidomide tablets once daily in the treatment of active ankylosing spondylitis. 2. To explore dose-effect relationships of taking thalidomide tablets once daily in the treatment of active ankylosing spondylitis, as well as selecting the appropriate dose for the further larger scale clinical trials.","other_id":"SLDA-201","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  (1) Active Ankylosing Spondylitis, Age 18-65, both outpatient or inpatient, both\r\n             gender;\r\n\r\n          -  (2) AS patients after traditional therapy (Using NSAIDs in a stable dose for 1 month,\r\n             using oral corticosteroids, using NSAIDs for 3 months) still in active stage;\r\n\r\n          -  (3) Pregnancy test must be negative in the female subjects of childbearing age or wife\r\n             of the male subjects;\r\n\r\n          -  (4)Female subjects with fertility during the trial (of 32 weeks) agreed to take a\r\n             double medically accepted and reliable contraceptive measures, which includes a drug\r\n             and a non-drug contraceptive measures; if the spouses of male subjects have fertility,\r\n             agreed to use latex condoms for contraception;\r\n\r\n          -  (5)Willing to have the treatment according to the plan as well as do the follow-up\r\n             exam on time;\r\n\r\n          -  (6)Understand and voluntarily signed informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  (1) Suffering from or have suffered from rheumatoid arthritis, disc prolapse, septic\r\n             arthritis, diffuse idiopathic skeletal hyperostosis syndrome, iliac dense osteitis,\r\n             psoriatic arthritis, bowel disease arthritis, Reiter syndrome;\r\n\r\n          -  (2) Severe AS, spine completely stiff (X-ray class IV) or the disease has been shown\r\n             to have a shorter survival period;\r\n\r\n          -  (3) Previously had total hip arthroplasty surgical treatment or appropriate to have\r\n             the surgery;\r\n\r\n          -  (4) Previously received anti-TNF therapy;\r\n\r\n          -  (5) Used leflunomide within 3 months before screening;\r\n\r\n          -  (6) Severe or persistent infection requires antimicrobial therapy;\r\n\r\n          -  (7) Hepatitis B surface antigen or hepatitis C antibody test positive;\r\n\r\n          -  (8) HIV positive or have acquired immunodeficiency syndrome (AIDS) history;\r\n\r\n          -  (9) Malignancy, lymphoproliferative disease history;\r\n\r\n          -  (10) Severe diabetes;\r\n\r\n          -  (11) Resting hypotension (BP<90/50 mmHg) or hypertension (BP>170/100 mmHg), and\r\n             orthostatic hypotension and clinically significant ECG abnormalities;\r\n\r\n          -  (12) Over the past six months had a stroke, heart attack or other serious\r\n             cardiovascular disease (including heart failure, unstable angina or life-threatening\r\n             arrhythmias and coronary artery bypass graft surgery);\r\n\r\n          -  (13) WBC or neutrophils below the lower limit of normal;\r\n\r\n          -  (14) Liver dysfunction, AST or ALT l> 2 times the upper limit of normal;\r\n\r\n          -  (15) Renal dysfunction, Cr>2 times the upper limit of normal;\r\n\r\n          -  (16) Female subjects or spouses of male subjects have positive pregnancy test or be in\r\n             the sickling period or intend to fertility or unwilling to take effective\r\n             contraception;\r\n\r\n          -  (17) With clinical symptoms of serious drug abuse or alcohol abuse or mental illness\r\n             history;\r\n\r\n          -  (18) Participated in any clinical trials of drugs within 3 months before screening;\r\n\r\n          -  (19) Workers engaged in dangerous (eg drivers, machine operator, high-altitude\r\n             operations, etc.);\r\n\r\n          -  (20) A history of deep venous thrombosis or pulmonary embolism;\r\n\r\n          -  (21) Be allergic to Test drug ingredients (including excipients);\r\n\r\n          -  (22) Other reasons for not be enrolled.\r\n      ","sponsor":"Shanghai Pharmaceuticals Holding Co., Ltd","sponsor_type":"Industry","conditions":"Ankylosing Spondylitis","interventions":[{"intervention_type":"Drug","name":"Drug: Thalidomide 150mg"},{"intervention_type":"Drug","name":"Drug: Thalidomide 100mg"},{"intervention_type":"Drug","name":"Drug: Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20)","time_frame":"week 12"},{"outcome_type":"secondary","measure":"Change of ASDAS score","time_frame":"week 12"},{"outcome_type":"secondary","measure":"Change of ASDAS score","time_frame":"week 24"},{"outcome_type":"secondary","measure":"Mean change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)","time_frame":"week 24"},{"outcome_type":"secondary","measure":"Mean change from baseline in Bath Ankylosing Spondylitis Function Index(BASFI)","time_frame":"week 24"},{"outcome_type":"secondary","measure":"Mean change from baseline in Nocturnal Pain using a Visual Analog Scale(VAS)","time_frame":"week 24"},{"outcome_type":"secondary","measure":"Mean change from baseline in back pain using a Visual Anolog Scale(VAS)","time_frame":"week 24"},{"outcome_type":"secondary","measure":"Morning stiffness","time_frame":"week 24"},{"outcome_type":"secondary","measure":"Number of Peripheral swollen joints","time_frame":"week 24"},{"outcome_type":"secondary","measure":"Number of Peripheral joint tenderness","time_frame":"week 24"},{"outcome_type":"secondary","measure":"Chest expansion","time_frame":"week 24"},{"outcome_type":"secondary","measure":"ESR","time_frame":"week 24"},{"outcome_type":"secondary","measure":"CRP","time_frame":"week 24"},{"outcome_type":"secondary","measure":"Schober test","time_frame":"week 24"},{"outcome_type":"secondary","measure":"Scoliosis","time_frame":"week 24"}]}
{"nct_id":"NCT01874015","start_date":"2013-02-28","phase":"Phase 1","enrollment":10,"brief_title":"Transplantation of Bone Marrow Mesenchymal Stem Cell in Crohn's Disease","official_title":"Transplantation of Bone Marrow Mesenchymal Stem Cell in Moderate to Severe Fistulizing Crohn's Disease","primary_completion_date":"2017-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2018-02-28","last_update":"2017-04-27","description":"This study is a prospective, randomized, parallel, phase 1 trial to assess the safety and feasibility of the transplantation of bone marrow derived mesenchymal stem cells (MSCs) in fistulizing Crohn's disease.","other_id":"Royan-GI-003","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  1- Poor response to routine treatments in refractory Crohn's disease with fistula.\r\n\r\n             2- CDAI>220 3- Age 18 to 60 years 4- GFR>30, Cr<2 5- The presence of perinea fistula.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  pregnancy\r\n      ","sponsor":"Royan Institute","sponsor_type":"Other","conditions":"Crohn's Disease","interventions":[{"intervention_type":"Biological","name":"Biological: mesenchymal cell transplantation","description":"Mesenchymal cell transplantation in patients with Crohn's disease."},{"intervention_type":"Biological","name":"Biological: mesenchymal cell and fibroblast injection","description":"Transplantation of mesenchymal cell and fibroblast in patients with crohn's disease."}],"outcomes":[{"outcome_type":"primary","measure":"fistula closure","time_frame":"4months","description":"Evaluation the fistula closure after mesenchymal cell transplantation in patients with crohn's disease."},{"outcome_type":"secondary","measure":"CDAI","time_frame":"4months","description":"Evaluation the decrease of CDAI after mesenchymal cell transplantation."}]}
{"nct_id":"NCT01920321","start_date":"2013-02-28","phase":"Phase 1/Phase 2","enrollment":20,"brief_title":"Bronchoscopic Thermal Saline Ablation (BTSA) of Emphysematous Lung. A New Emphysema Therapy","official_title":"Lung Volume Reduction in COPD Patients With an Inhomogeneous Severe Emphysema Located in the Upper Lobes, by Injecting Warm Saline Through the Bronchoscope Channel","primary_completion_date":"2014-06-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2014-12-31","last_update":"2013-08-12","description":"Aim: To evaluate feasibility, safety and efficacy of relatively simple approach of bronchoscopic lung volume reduction (LVR) technology, independent of collateral ventilation. Description: Patients with severe upper lobes heterogeneous emphysema, undergo unilateral bronchoscopic installation of saline thermal energy 50-55 C intending to induce an inflammatory airway and parenchymal injury and consequently fibrotic response resulting in LVR;","other_id":"195/12","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":40,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age 40-75 unlimited sex. 20 subjects\r\n\r\n          2. COPD, GOLD 3-4 (global obstructive lung disease).\r\n\r\n          3. CT scan of lung and included high resolution slices. Demonstrating emphysematous,\r\n             bullotic changes in the upper lobes.\r\n\r\n          4. Pulmonary function tests results- TLC> 110%, RV> 150%, DLCO <80%,FEV1: 15-45%.\r\n\r\n          5. 6 minute walking distance > 140 meters.\r\n\r\n             -\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Active ischemic heart disease, significant arrhythmia. Ejection fraction (EF) <40%.\r\n\r\n          2. Chronic lung disease that cause CO2 retention above 50 mm Hg and / or oxygen\r\n             saturation at rest below 88%.\r\n\r\n          3. Pulmonary hypertension> 45 mmHg, according to the Echo Test.\r\n\r\n          4. . Cancer treatment with chemotherapy / radiation or expected life expectancy of less\r\n             than two years.\r\n\r\n          5. Pregnancy -\r\n      ","sponsor":"Assaf-Harofeh Medical Center","sponsor_type":"Other","conditions":"Emphysema","interventions":[{"intervention_type":"Procedure","name":"Procedure: Endoscopic lung volume reduction","description":"Prior the procedure patients undergo - high resolution chest CT , extensive phisiological assessment."}],"outcomes":[{"outcome_type":"primary","measure":"Pulmonary function improvemnt","time_frame":"6 months","description":"Clinical - COPD assessment test (CAT ) + lung volumes + diffusion capaciry and 6MWD ."}]}
{"nct_id":"NCT01726075","start_date":"2013-02-28","phase":"Phase 2/Phase 3","enrollment":450,"brief_title":"Trial to Assess the Efficacy of Neuroprotective Drugs Administered Topically to Prevent or Arrest Diabetic Retinopathy","official_title":"Neurodegeneration as Early Event in Pathogenesis of Diabetic Retinopathy:Multicentric, Prospective, Ph. II-III,Random.Controlled Trial to Assess Efficacy of Neuroprotective Drugs Administered Topically to Prevent/Arrest Diabetic Retinopathy","primary_completion_date":"2015-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-11-30","last_update":"2016-01-12","description":"To assess whether neuroprotective drugs administered topically (somatostatin and brimonidine) are able to prevent or arrest the development and progression of neurodegenerative changes","other_id":"4C-2011-02","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":45,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patients with type 2 diabetes mellitus\r\n\r\n          2. Diabetes duration  5 years\r\n\r\n          3. Aged between 45-75 years-old\r\n\r\n          4. ETDRS level < 20 (microaneurysms absent) (50% of enrolled patients) Or ETDRS levels 20\r\n             or 35 with presence of at least one microaneurysm in Field 2 between the superior and\r\n             inferior arcades (50% of enrolled patients) in the Study Eye as determined by the\r\n             Reading Centre.\r\n\r\n          5. Informed Consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Previous laser photocoagulation\r\n\r\n          2. Other diseases which may induce retinal degeneration (e.g. glaucoma)\r\n\r\n          3. Subject with a refractive error   5 diopter\r\n\r\n          4. Inadequate ocular media and/ or pupil dilatation that do not permit good quality\r\n             fundus photography.\r\n\r\n          5. Renal failure (creatinine > 1.4 mg/dl)\r\n\r\n          6. HbA1C > 10 % in the previous 6 months and at Screening\r\n\r\n          7. Subjects taking somatostatin or brimonidine, for any indication, in the previous 3\r\n             months\r\n\r\n          8. Subject has a condition or is in a situation which may put the subject at significant\r\n             risk, may confound the study results or may interfere significantly with the patient's\r\n             participation in the study.\r\n\r\n          9. Pregnancy or nursing\r\n\r\n         10. Hypersensitivity to the active substances to be tested or to any of the excipients\r\n\r\n         11. Subject receiving systemic monoamine oxidase (MAO) inhibitor therapy or\r\n             antidepressants which affect noradrenergic transmission (e.g. tricyclic\r\n             antidepressants and mianserin)\r\n      ","sponsor":"BCN Peptides","sponsor_type":"Industry","conditions":"Diabetic Retinopathy","interventions":[{"intervention_type":"Drug","name":"Drug: COLIRIOBCN070660","description":"One drop per eye twice a day during 24 months"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"One drop per eye twice a day during 24 months"},{"intervention_type":"Drug","name":"Drug: Brimonidine","description":"One drop per eye twice a day during 24 months"}],"outcomes":[{"outcome_type":"secondary","measure":"Retinal thickness assessed by SD-OCT at month 6","time_frame":"month 6"},{"outcome_type":"secondary","measure":"Retinal thickness assessed by SD-OCT at month 12","time_frame":"month 12"},{"outcome_type":"secondary","measure":"Retinal thickness assessed by SD-OCT at month 18","time_frame":"month 18"},{"outcome_type":"secondary","measure":"Retinal thickness assessed by SD-OCT at month 24","time_frame":"month 24"},{"outcome_type":"secondary","measure":"Central retinal thickness assessed by SD-OCT at month 0","time_frame":"month 0"},{"outcome_type":"other","measure":"Best Corrected Visual Acuity (BCVA) assessed by ETDRS scale at month 0","time_frame":"month 0"},{"outcome_type":"other","measure":"BCVA assessed by ETDRS scale at month 6","time_frame":"month 6"},{"outcome_type":"other","measure":"BCVA assessed by ETDRS scale at month 12","time_frame":"month 12"},{"outcome_type":"other","measure":"BCVA assessed by ETDRS scale at month 18","time_frame":"month 18"},{"outcome_type":"other","measure":"BCVA assessed by ETDRS scale at month 24","time_frame":"month 24"},{"outcome_type":"other","measure":"Visual Fields defects assessed by Visual Fields Test at month 0","time_frame":"month 0"},{"outcome_type":"secondary","measure":"Central retinal thickness assessed by SD-OCT at month 6","time_frame":"month 6"},{"outcome_type":"secondary","measure":"DR severity assessed by ETDRS scale CFP - 30º/35º-7 fields at month 24","time_frame":"month 24"},{"outcome_type":"secondary","measure":"Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at baseline","time_frame":"baseline"},{"outcome_type":"secondary","measure":"Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 6","time_frame":"month 6"},{"outcome_type":"secondary","measure":"Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 12","time_frame":"month 12"},{"outcome_type":"secondary","measure":"Central retinal thickness assessed by SD-OCT at month 12","time_frame":"month 12"},{"outcome_type":"secondary","measure":"Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 18","time_frame":"month 18"},{"outcome_type":"secondary","measure":"Central retinal thickness assessed by SD-OCT at month 18","time_frame":"month 18"},{"outcome_type":"secondary","measure":"Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 24","time_frame":"month 24"},{"outcome_type":"secondary","measure":"Retinal thickness assessed by SD-OCT at month 0","time_frame":"month 0"},{"outcome_type":"primary","measure":"Changes in the Implicit Time assessed by mfERG (IT-mfERG) at month 6, 12, 18 and 24","time_frame":"month 24"},{"outcome_type":"secondary","measure":"Retinal Nerve Fiber Layer (RNFL) assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) at month 0","time_frame":"month 0"},{"outcome_type":"secondary","measure":"Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 6","time_frame":"month 6"},{"outcome_type":"secondary","measure":"Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 12","time_frame":"month 12"},{"outcome_type":"secondary","measure":"Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 18","time_frame":"month 18"},{"outcome_type":"secondary","measure":"Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 24","time_frame":"month 24"},{"outcome_type":"secondary","measure":"Ganglion Cell Layer (GCL) assessed by SD-OCT at month 0","time_frame":"month 0"},{"outcome_type":"secondary","measure":"Ganglion Cell Layer (GCL) assessed by SD-OCT at month 6","time_frame":"month 6"},{"outcome_type":"secondary","measure":"Ganglion Cell Layer (GCL) assessed by SD-OCT at month 12","time_frame":"month 12"},{"outcome_type":"secondary","measure":"Ganglion Cell Layer (GCL) assessed by SD-OCT at month 18","time_frame":"month 18"},{"outcome_type":"secondary","measure":"Ganglion Cell Layer (GCL) assessed by SD-OCT at month 24","time_frame":"month 24"},{"outcome_type":"secondary","measure":"Central retinal thickness assessed by SD-OCT at month 24","time_frame":"month 24"},{"outcome_type":"secondary","measure":"Diabetic Retinopathy (DR) severity assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) scale CFP - 30º/35º-7 fields at baseline","time_frame":"baseline"},{"outcome_type":"other","measure":"Visual Fields defects assessed by Visual Fields Test at month 24","time_frame":"month 24"},{"outcome_type":"other","measure":"Visual health assessed by Visual Function Questionnaire (VFQ-25) at month 0","time_frame":"month 0"},{"outcome_type":"other","measure":"Visual health assessed by Visual Function Questionnaire (VFQ-25) at month 24","time_frame":"month 24"},{"outcome_type":"other","measure":"Adverse Events assessed by inquiry at month 0","time_frame":"month 0"},{"outcome_type":"other","measure":"Adverse Events assessed by inquiry at month 3","time_frame":"month 3"},{"outcome_type":"other","measure":"Adverse Events assessed by inquiry at month 6","time_frame":"month 6"},{"outcome_type":"other","measure":"Adverse Events assessed by inquiry at month 12","time_frame":"month 12"},{"outcome_type":"other","measure":"Adverse Events assessed by inquiry at month 18","time_frame":"month 18"},{"outcome_type":"other","measure":"Adverse Events assessed by inquiry at month 24","time_frame":"month 24"},{"outcome_type":"other","measure":"ophthalmological examination: Refractive Error, Slit Lamp Exam, Ophthalmoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve), Intra-Ocular Pressure (IOP) Measurement at month 0","time_frame":"month 0"},{"outcome_type":"other","measure":"ophthalmological examination: Refractive Error, Slit Lamp Exam, Ophthalmoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve), Intra-Ocular Pressure (IOP) Measurement at month 3","time_frame":"month 3"},{"outcome_type":"other","measure":"ophthalmological examination: Refractive Error, Slit Lamp Exam, Ophthalmoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve), Intra-Ocular Pressure (IOP) Measurement at month 6","time_frame":"month 6"},{"outcome_type":"other","measure":"ophthalmological examination: Refractive Error, Slit Lamp Exam, Ophthalmoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve), Intra-Ocular Pressure (IOP) Measurement at month 12","time_frame":"month 12"},{"outcome_type":"other","measure":"ophthalmological examination: Refractive Error, Slit Lamp Exam, Ophthalmoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve), Intra-Ocular Pressure (IOP) Measurement at month 18","time_frame":"month 18"},{"outcome_type":"other","measure":"ophthalmological examination: Refractive Error, Slit Lamp Exam, Ophthalmoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve), Intra-Ocular Pressure (IOP) Measurement at month 24","time_frame":"month 24"}]}
{"nct_id":"NCT01627574","start_date":"2013-02-28","phase":"N/A","enrollment":272,"brief_title":"Contraceptive Awareness and Reproductive Education","official_title":"Contraceptive Awareness and Reproductive Education","primary_completion_date":"2018-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-06-30","last_update":"2020-12-01","description":"The long-term objectives of this research are to develop effective treatments to reduce unplanned pregnancy and Sexually Transmitted Infections (STIs) for a highly under-served at-risk youth population.","other_id":"HD065942","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"Female","minimum_age":14,"maximum_age":21,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  1) Age 14-21;\r\n\r\n          -  2) Currently sexually active with males defined as having had coital sex and intending\r\n             to have coital sex within the next 6 months;\r\n\r\n          -  3) Willing to comply with protocol, follow-up assessments, and provide at least one\r\n             locator; and\r\n\r\n          -  4) Fluent in English.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  1) Inability to give informed consent secondary to organic brain dysfunction, or\r\n             active psychosis or otherwise not able to participate in the intervention or\r\n             assessments (deaf, blind, or impaired communication skills that preclude participation\r\n             in assessment or counseling);\r\n\r\n          -  2) Girls who are not sexually active; or\r\n\r\n          -  3) Currently pregnant.\r\n      ","sponsor":"University of Rhode Island","sponsor_type":"Other","conditions":"Pregnancy|Sexually Transmitted Infections","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Motivational Intervention","description":"There are two, 45-60 minutes sessions of tailored MI that occur at the enrollment of the study, and at 3 month follow-up."},{"intervention_type":"Behavioral","name":"Behavioral: Didactic Educational Intervention","description":"There are two, 45-60 minute didactic sessions designed to provide information and awareness for sexual health involving contraception and STI prevention. The first session occurs after enrollment in the study, the second at 3 month follow-up."}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants With Continuous Use of Highly Effective Contraceptives Over 9 Months.","time_frame":"9 month follow-up","description":"Using the Timeline Followback (TLFB): Contraceptive use was measured via a calendar recall for both interventions.Continuous use of highly effective contraceptives at 9 Month follow up is determined if a participant remains on a highly effective contraceptive for 9 months. A participant switching from one highly effective contraceptive method to another is recorded as maintaining continuous contraceptive use at follow-up if she switches methods during times when the original method is still effective."},{"outcome_type":"primary","measure":"Number of Participants With a Positive STI Test After A Baseline Negative Test.","time_frame":"9 month follow-up","description":"Conducted STI testing for T. vaginalis, N. gonorrhoeae, and C. trachomatis through urine specimen collection. If a participant is diagnosed with an STI at baseline the youth will be referred for treatment at a Title X clinic and will be retested at the next follow-up visit. Any positive test after a baseline negative test will be documented as an incident infection."},{"outcome_type":"primary","measure":"Number of Participants Who Initiated a Highly Effective Contraceptive Post Treatment in 9 Months.","time_frame":"9 month follow up","description":"Using the Timeline Followback (TLFB): The types of contraceptives used was captured via a calendar recall for both interventions. Initiation of highly effective contraceptives is determined if a participant ever endorses beginning a highly effective contraceptive at any time within 9 months."},{"outcome_type":"secondary","measure":"Number of Participants With a Positive Pregnancy Test After Baseline Assessment","time_frame":"9 month follow up","description":"The secondary outcome is pregnancy as documented by a positive pregnancy test by at follow-up visit. Pregnancy tests were administered by urine collection and Home Pregnancy Test sticks."},{"outcome_type":"secondary","measure":"Number of Participants Who Used Condoms 100% of the Time Thus Reducing the Risk of STIs.","time_frame":"9 month follow up","description":"Using the Timeline Followback (TLFB): Condom use was measured via a calendar recall for both interventions. Participants indicate whether or not condoms were used each time sex was reported."}]}
{"nct_id":"NCT01858584","start_date":"2013-02-28","phase":"N/A","enrollment":75,"brief_title":"Prospective, Comparative, Randomized, Controlled Trial on the Efficacy of the Treatment of Gastroesophageal Reflux Infant With Magnesium Alginate","official_title":"Prospective, Comparative, Randomized, Controlled Trial on the Efficacy of the Treatment of Gastroesophageal Reflux Infant With Magnesium Alginate","primary_completion_date":"2013-12-31","study_type":"Interventional","rec_status":"Unknown status","last_update":"2013-05-30","description":"The results on the efficacy of the formulations based on alginic acid are controversial. Corvaglia et al demonstrated a significant reduction in reflux episodes in preterm infants by evaluation with pH-impedance analysis. This study concludes that the use of alginic acid reduces the acidity of the gastroesophageal reflux (GER) and has a non-systemic effect and a lesser presence of side effects compared to the use of H2-receptor antagonist(H2RA) and proton pump inhibitor (PPI).","other_id":"STDMG2013","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","maximum_age":1,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age < 1 year\r\n\r\n          -  Suggestive symptoms of gastroesophageal reflux (I-GERQ score > 7)\r\n\r\n          -  Absence of clinical evidence of allergy to cow milk protein or other allergic disorder\r\n\r\n          -  No previous intake of thickened formulas, acid suppressants or drugs\r\n\r\n          -  All parents or guardians must sign a document of informed consent\r\n\r\n          -  Patients affected by chronic disease\r\n\r\n          -  Patients affected by hepatic or renal diseases\r\n\r\n          -  Patients affected by cardiac diseases\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients affected by chronic disease\r\n\r\n          -  Patients affected by hepatic or renal diseases\r\n\r\n          -  Patients affected by cardiac diseases\r\n\r\n          -  Inability or unwillingness to give informed consent\r\n\r\n          -  Patients wth severe neurologic disease\r\n\r\n          -  Patients affected by cow milk protein allergy\r\n\r\n          -  Previous or ongoing intake of thickened formulas, acid suppressants or drugs\r\n      ","sponsor":"Federico II University","sponsor_type":"Other","conditions":"Gastroesophageal Reflux|Regurgitation|Vomiting|Chronic Cough","interventions":[{"intervention_type":"Drug","name":"Drug: Gastrotuss","description":"Gastrotuss baby: syrup based on alginate consisting of: magnesium alginate, simethicone, fructose, xanthan gum, honey, D-panthenol, fluid extracts of Althaea officinalis, Papaver rhoeas, zinc oxide, sodium bicarbonate, sodium hydroxide, p-hydroxybenzoate of methyl-sodium, sodium propyl p-hydroxybenzoate, natural flavors, erythrosine (E127), purified water.\r\ndosage:\r\nInfants weighing <5 kg in 2.5 ml 5-10 min after feeding. In case of regurgitation after administration, 1 ml additional\r\nInfants weighing> 5 kg per 5 ml dose after the meal and the evening before putting the baby to sleep The administration should be maximum 3 times per day"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: thickened milk","description":"Milk thickened (formulat AR): contains a special thickener derived from corn starch waxy, that maintains its fluidity into the bottle and thickens just inside the stomach of the child, and this makes it easy to use in breastfeeding , as it is usable with a common teat."}],"outcomes":[{"outcome_type":"primary","measure":"efficacy on GER","time_frame":"2 months","description":"This prospective, randomized, controlled trial aims to determine, in a population of infants within one year of life, suffering from RGE the effectiveness of magnesium alginate. The clinical improvement of the patient will be evaluated based on the negativity of the symptom score (4.3.1), assessed using a validated questionnaire on symptoms of GER (I-GERQ Annex A)."},{"outcome_type":"secondary","measure":"comparison of treatments","time_frame":"2 months","description":"• To compare the efficacy of Magnesium Alginate on GER in infants compared with those of thickened feeding and reassurance."}]}
{"nct_id":"NCT01914458","start_date":"2013-02-28","phase":"Phase 2","enrollment":600,"brief_title":"Image Discovering Early Lung Cancer Project","official_title":"Low-Dose Computed Tomography for Lung Cancer Screening in High Risk Asymptomatic Patients: the Taiwan Study","primary_completion_date":"2018-01-31","study_type":"Interventional","rec_status":"Unknown status","last_update":"2013-08-02","description":"Lung cancer is the leading cause of cancer related death in Taiwan and world wide. The application of low dose helical computed tomography (CT) has been the milestone of lung cancer screening. Recently, The National Lung Screening Trial (NLST) shows screening with low-dose CT could reduce mortality from lung cancer. We conducted this clinical trial to determine the efficacy of low dose CT in early lung cancer screening in Taiwan.","other_id":"CGH-LP101004","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":50,"maximum_age":74,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age 50-74 years\r\n\r\n          -  30 or more pack-years of cigarette smoking history\r\n\r\n          -  Former smokers: quit smoking within the previous 15 years\r\n\r\n          -  Ability to tolerate CT procedure\r\n\r\n          -  Signed informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Severe uncontrolled heart, vascular, respiratory or endocrine pathology.\r\n\r\n          -  Life-expectancy less than 1 year\r\n\r\n          -  History of lung cancer\r\n\r\n          -  Acute respiratory disease\r\n\r\n          -  Hemoptysis.\r\n\r\n          -  Weight loss more than 6.8 kg in the 12 months prior to eligibility assessment\r\n\r\n          -  Participation in other cancer clinical trial\r\n\r\n          -  Chest CT examination in the 12 months prior to eligibility assessment.\r\n      ","sponsor":"Cathay General Hospital","sponsor_type":"Other","conditions":"Lung Cancer","interventions":[{"intervention_type":"Procedure","name":"Procedure: Low-dose computed tomography (LDCT)","description":"Low-dose computed tomography scan"}],"outcomes":[{"outcome_type":"primary","measure":"Lung cancer detection rate","time_frame":"2 years","description":"Assess number of lung cancer diagnoses after radiological and morphological verification of positive lung nodules."},{"outcome_type":"secondary","measure":"Lung cancer mortality","time_frame":"5 years","description":"Assess lung cancer mortality in the screened group within next 5 years."},{"outcome_type":"secondary","measure":"All-cause mortality","time_frame":"5 years","description":"Assess all-cause mortality mortality within next 5 years."},{"outcome_type":"secondary","measure":"Nodule detection rate","time_frame":"3 months","description":"Estimate nodule detection rate, types (solid, part-solid, or ground glass opacity) and sizes of lung nodules found."},{"outcome_type":"secondary","measure":"Smoking cessation rate","time_frame":"one year","description":"Assess smoking cessation rate in the screened group within next one year."},{"outcome_type":"other","measure":"Coronary artery calcification","time_frame":"3 months","description":"Estimate coronary artery calcification score (Agatston Score)in the screened group."},{"outcome_type":"other","measure":"Incidence rate of cardiovascular accident","time_frame":"5 years","description":"Incidence rate of cardiovascular accident stratified by coronary artery calcification score in the screened group within next 5 years."},{"outcome_type":"other","measure":"Diagnosis accuracy of COPD diagnosis by low-dose computed tomography(CT)","time_frame":"2 years","description":"Assess diagnosis accuracy of COPD diagnosis by low-dose computed tomography(CT) (CT emphysema, CT air trapping) according to the reference standard of pulmonary function tests."},{"outcome_type":"other","measure":"Lung nodules management","time_frame":"12 months","description":"Assess algorithms for lung nodules management in a regional general hospital in Taiwan."},{"outcome_type":"other","measure":"Frequency of diagnostic procedures","time_frame":"12 months","description":"Estimate the frequency of diagnostic procedures, types of invasive and non-invasive procedures performed in a regional hospital in Taiwan."},{"outcome_type":"other","measure":"Complication of diagnostic procedures","time_frame":"12 months","description":"Assess the complication rate after diagnostic procedures performed after screening in a regional hospital in Taiwan. Procedures include baseline LDCT."}]}
{"nct_id":"NCT01936714","start_date":"2013-02-28","phase":"N/A","enrollment":50,"brief_title":"Comparison of Two Phacoemulsification-methods: Low Fluidic EasyTip 2.2mm vs. High Fluidic EasyTip 2.2mm","official_title":"Comparison of Two Phacoemulsification-methods: Low Fluidic EasyTip 2.2mm vs. High Fluidic EasyTip 2.2mm","primary_completion_date":"2013-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-09-30","last_update":"2015-04-10","description":"The aim of this study was to compare the intraoperative efficiency, safety and postoperative outcomes of cataract surgery with two different \"high-fluidic\" settings.","other_id":"EK Nr: 2007/2012","allocation":"Randomized","intervention_model":"Parallel Assignment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":50,"maximum_age":90,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  bilateral age-related cataract\r\n\r\n          -  good overall physical constitution\r\n\r\n          -  LOCS 2-5\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  previous intraocular surgery or ocular trauma\r\n\r\n          -  previous corneal pathology\r\n\r\n          -  previous endothelial cell count <1200\r\n\r\n          -  glaucoma\r\n\r\n          -  uveitis\r\n\r\n          -  PEX\r\n\r\n          -  diabetic retinopathy and any other severe retinal pathology that would make a\r\n             postoperative visual acuity of 20/40 (decimal equivalent = 0.5) or better unlikely\r\n\r\n          -  intraocular complication like posterior capsular\r\n\r\n          -  postoperative comlpications (e.g. postoperative uveitis)\r\n      ","sponsor":"Medical University of Vienna","sponsor_type":"Other","conditions":"Cataracts","interventions":[{"intervention_type":"Procedure","name":"Procedure: cataract surgery"}],"outcomes":[{"outcome_type":"primary","measure":"phacoemulsification time","time_frame":"intraoperative","description":"time spent for the phacoemulsification process was the phacoemulsification tip time (PTT) needed to divide the nucleus and the PTT needed to conquer it"},{"outcome_type":"primary","measure":"effective phacoemulsification time","time_frame":"intraoperative","description":"time in seconds required had 100% power been used throughout the phacoemulsification process documented for the separation of the nucleus (divide) and the aspiration of the quadrants (conquer)"},{"outcome_type":"primary","measure":"fluid volume","time_frame":"intraoperative","description":"amount of BSS used for dividing and conquering"},{"outcome_type":"secondary","measure":"postoperative corneal oedema","time_frame":"1 day, 1 week, 6 months","description":"central corneal thickness"},{"outcome_type":"secondary","measure":"postoperative endotheial cell loss","time_frame":"6 months"}]}
{"nct_id":"NCT01770288","start_date":"2013-02-28","phase":"N/A","enrollment":40,"brief_title":"Psychophysical Aspects of Maximal Anaerobic Performance","official_title":"Psychophysical Aspects of Maximal Anaerobic Performance","primary_completion_date":"2013-02-28","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2013-04-30","last_update":"2013-01-17","description":"During anaerobic exercise, the metabolic pathway of glycolysis is used in order to produces high-energy compounds adenosine triphosphate (ATP).The level of lactic acid in the blood is a marker to the increased protons concentration and acidosis.nevertheless, the increased level of protons in addition to the release of bradykinin causes pain during the exercise that limited the subject's performance. Therefore, it is assumed that the individual pain sensitivity might determine the subject's performance. Aims: To investigate the role of the DNIC efficiency in prediction of anaerobic performance in humans (2) to study the role of peripheral pro-nociceptive processing in mediating pain during anaerobic exercise and its contribution to the subjects' performance (3) to assess the function of pain-related psychological factors in anaerobic performance.","other_id":"8-12","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Screening","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        healthy Volunteers\r\n\r\n        Exclusion Criteria:\r\n\r\n        pregnancy\r\n      ","sponsor":"Hillel Yaffe Medical Center","sponsor_type":"Other","conditions":"Anaerobic Performance","interventions":[{"intervention_type":"Other","name":"Other: Anaerobic wingate test"}],"outcomes":[{"outcome_type":"primary","measure":"Pain psychophysics tests","time_frame":"1 year","description":"DNIC will be tested using a paradigm of two remote noxious stimuli with one, the 'conditioning stimulus' (immersing the hand in tub containing 8°c water), inhibiting the other, the 'test pain' (pressure pain threshold) in order to assess the EA efficiency (2) heat and pressure pain thresholds, and (3) temporal summation of painful heat and mechanical stimuli that reflect the neuroplasticity of the central nervous system following peripheral noxious stimulation."},{"outcome_type":"secondary","measure":"Lactate concentration","time_frame":"1 year","description":"Lactate concentration at rest will be measures using a portable lactate analyzer"},{"outcome_type":"secondary","measure":"The anaerobic performance","time_frame":"1 year","description":"will be evaluated during executing of Wingate test"}]}
{"nct_id":"NCT01856647","start_date":"2013-02-28","enrollment":1,"brief_title":"Pilot Study Characterizing Adipose Tissue Leukocytes by Flow Cytometry/Microscopy in Lean, Obese and Psoriatic Subjects","official_title":"A Pilot Study to Characterize Adipose Tissue Leukocytes by Flow Cytometry and Microscopy in Lean, Obese and Psoriatic Subjects (Lean/Obese)","primary_completion_date":"2015-12-31","study_type":"Observational","rec_status":"Terminated","completion_date":"2015-12-31","last_update":"2015-12-21","description":"Obesity is an insulin resistance-associated metabolic disorder which is a hallmark of and risk factor for type 2 diabetes and the metabolic syndrome, often linked to cardiovascular disease, certain cancers and inflammatory diseases.The phenotyping of subcutaneous adipose tissue (SAT) hematopoetic cells from obese subjects by flow cytometry, microscopy and gene expression will enable us to identify inflammation in this tissue and may help us to understand the causes and consequences of obesity in order to determine how these cells might be implicated in the initiation and/or progression of the aforementioned diseases.","other_id":"JUG-0799","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":65,"population":"Obesity and psoriasis are characterized by infiltration of inflammatory cells (leukocytes)\r\n        in SAT and skin, respectively. We expect that SAT in obese psoriasis subjects will have\r\n        infiltrating inflammatory leukocytes because of obesity, and that these infiltrating\r\n        leukocytes might be different and/or increased in numbers by the pathology of psoriasis","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Psoriatic lean cohort (BMI between 18-24.9 Kg/m2): moderate to severe plaque-type, at\r\n             least 5% of BSA\r\n\r\n          -  Psoriatic obese cohort (BMI between 30-40 Kg/m2): moderate to severe plaque-type, at\r\n             least 5% of BSA\r\n\r\n          -  Lean/non-psoriatic cohort: BMI between 18-24.9 Kg/m2\r\n\r\n          -  Overweight/obese non-psoriatic cohort: BMI between 30-40 Kg/m2\r\n\r\n          -  Subjects must be 18-65 years of age\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Having received any systemic treatment for psoriasis within the last 30 days\r\n\r\n          -  history of bleeding disorder\r\n\r\n          -  weight loss of 10 pounds in the last four weeks\r\n\r\n          -  current smoker\r\n\r\n          -  Known diagnosis of any unrelated autoimmune disease or inflammatory disease ( i.e.\r\n             lupus, atopic dermatitis, rheumatoid arthritis).\r\n\r\n          -  Currently taking NSAIDS, aspirin, (if > once a week, stopped <30 days ago). Aspirin\r\n             81mg may be permitted if the Framingham Risk Score is < 10\r\n\r\n          -  Having received any anti-inflammatory medication within the last 30 days\r\n\r\n          -  Current use of any anti-coagulants\r\n\r\n          -  LFTs > 2 x upper normal limits\r\n\r\n          -  HIV infection\r\n\r\n          -  Pregnant\r\n\r\n          -  Less than 6 weeks post partum\r\n\r\n          -  history of cardiovascular disease (MI, CHF, CVA)\r\n\r\n          -  Any cancer diagnosis within the last 5 years\r\n\r\n          -  Symptoms of acute illness such as upper respiratory infection, bronchitis,\r\n             gastroenteritis, or fever within 3 days of Visit 1\r\n\r\n          -  Any medical, psychological or social condition that, in the opinion of the\r\n             Investigator, would jeopardize the health or well-being of the participant during any\r\n             study procedures or the integrity of the data\r\n\r\n          -  ingestion of DHA or fish oil within last 90 days\r\n\r\n          -  hypertension as defined as > 140 systolic and > 90 diastolic after 10 minutes of\r\n             resting on 2 antihypertensives\r\n\r\n          -  Use of statins within the last 30 days\r\n      ","sponsor":"Rockefeller University","sponsor_type":"Other","conditions":"Psoriasis|Obesity","interventions":[{"intervention_type":"Procedure","name":"Procedure: Adipose tissue biopsy (fat biopsy)","description":"An adipose tissue biopsy will be performed after a 10-12 hour overnight fast. A small sample of fat tissue will be removed from the subject for gene expression analysis. A subcutaneous fat biopsy (~3 ml) will be obtained from the lower abdomen following local anesthesia."}],"outcomes":[{"outcome_type":"primary","measure":"Biomarkers for phenotyping a new type of leukocyte","time_frame":"5 years","description":"Biomarkers for phenotyping a new type of leukocyte"}]}
{"nct_id":"NCT01932502","start_date":"2013-02-28","phase":"Phase 4","enrollment":21,"brief_title":"Evaluation of Onfi Conversion Therapy Replacing Clonazepam in Patients With Medically Refractory Epilepsy","official_title":"Evaluation of Onfi Conversion Therapy Replacing Clonazepam in Patients With Medically Refractory Epilepsy: Efficacy, Tolerability, Dosing Equivalence, and Retention Rate","primary_completion_date":"2017-06-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2017-09-30","last_update":"2017-03-03","description":"The purpose of the study is to examine the clinical safety, tolerability, and efficacy of clobazam (Onfi) when it replaces the pre-existing clonazepam therapy in patients with refractory epilepsy.","other_id":"13BN001","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subject has a confirmed diagnosis of medically refractory epilepsy with or without\r\n             secondary generalization for at least 12 months prior to the initial study visit.\r\n\r\n          -  Currently taking stable dosing regimen of clonazepam (0.5-4mg daily) for seizure\r\n             control.\r\n\r\n          -  Takes at least one additional Anti-epileptic drug besides benzodiazepine.\r\n\r\n          -  Age 18-70 years, inclusive.\r\n\r\n          -  In opinion of investigator, can be safely treated with Onfi.\r\n\r\n          -  Minimum of 2 seizures, but no more than 24 complex partial or generalized seizures,\r\n             during the 8-week baseline period prior to study entry.\r\n\r\n          -  Able to communicate effectively with study personnel and considered reliable, able,\r\n             willing, and cooperative with regard to complying with protocol-defined requirements,\r\n             including completion of study diary.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Clinically relevant current illness or history of that may interfere with the\r\n             subject's ability to complete the study as determined by the investigator.\r\n\r\n          -  History of status epilepticus within 6 months prior to the initial study visit.\r\n\r\n          -  History of suicidal attempts or suicidal ideation within 12 months of initial visit.\r\n      ","sponsor":"St. Joseph's Hospital and Medical Center, Phoenix","sponsor_type":"Other","conditions":"Refractory Epilepsy","interventions":[{"intervention_type":"Drug","name":"Drug: clobazam (Onfi)","description":"Subject's clonazepam will be converted to the following Onfi doses per day:\r\nClonazepam 0.5mg converted to Onfi 10mg first week, then titrated up to 40mg per day.\r\nClonazepam 1.0-2.0mg converted to Onfi 20mg first week, then titrated up to 40mg per day.\r\nClonazepam 2-4mg converted to Onfi 20mg first week, then titrated up to 60mg per day.\r\nInitial conversion will occur over two weeks followed by upward titration of up to 10mg increment per week toward the target dose. Down titration of up to 10mg will be allowed during the study.\r\nThe following will be the initial conversion schedule from clonazepam to Onfi:\r\nWeek 1: 50% reduction of clonazepam and starting dose of Onfi, replacing the reduced clonazepam dose with the conversion rate of clonazepam 0.5mg = Onfi 10mg.\r\nWeek 2: Discontinuing clonazepam and increasing the dosage of Onfi by two-fold. Week 3+: Titrate the dose of Onfi up to 40mg per day as tolerated"},{"intervention_type":"Drug","name":"Drug: Initial conversion and titration","description":"Initial conversion will occur over two weeks followed by upward titration of up to 10mg increment per week toward the target dose. Down titration of up to 10mg will be allowed during the study."},{"intervention_type":"Drug","name":"Drug: Conversion schedule - Week 1","description":"The following will be the initial conversion schedule from clonazepam to Onfi:\r\nWeek 1: 50% reduction of clonazepam and starting dose of Onfi, replacing the reduced clonazepam dose with the conversion rate of clonazepam 0.5mg=Onfi 10mg."},{"intervention_type":"Drug","name":"Drug: Conversion schedule - Week 2","description":"Week 2: Discontinuing clonazepam and increasing the dosage of Onfi by two-fold."},{"intervention_type":"Drug","name":"Drug: Conversion schedule - Week 3","description":"Week 3+: Titrate the dose of Onfi up to 40mg per day as tolerated."}],"outcomes":[{"outcome_type":"primary","measure":"Efficacy","time_frame":"28 days","description":"Efficacy will be measured by percentage of mean seizure reduction averaged over 28 days."},{"outcome_type":"secondary","measure":"Tolerability","time_frame":"Weeks 6 - 52 after medication conversion","description":"Retention rate, which indirectly measures the therapeutic tolerance, will be measured at 6 weeks, 12 weeks, 24 weeks, and 52 weeks."},{"outcome_type":"secondary","measure":"Retention","time_frame":"52 weeks","description":"Retention rate of Onfi at 6-months and 12-months."}]}
{"nct_id":"NCT01803178","start_date":"2013-02-28","phase":"N/A","enrollment":240,"brief_title":"The Effect of Plant Sterols on Vascular Function","official_title":"The Effect of Plant Sterols on Vascular Function","primary_completion_date":"2013-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-08-31","last_update":"2013-10-28","description":"The main aim of the study is to investigate, in humans, the effect of plant sterols on vascular function by measuring flow-mediated dilation (FMD). This study also aims to study the effect of plant sterols on pulse wave velocity (PWV), aortic augmentation index (Aix), central blood pressure (CBP), office blood pressure (BP), blood lipids and plasma plant sterol concentration. At last, the effects of plant sterols on z-scores of circulating biomarkers of endothelial dysfunction and low-grade inflammation will be assessed. For all study outcomes, effect sizes and 95% confidence intervals will be estimated. Hypothesis: Based on available evidence, it is hypothesized that plant sterols modestly increase FMD.","other_id":"FDS-SCC-0574","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":40,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Apparently healthy men and post-menopausal women\r\n\r\n          -  BMI  18 and  30 kg/m2.\r\n\r\n          -  Aged between 40 - 65 years.\r\n\r\n          -  Having elevated LDL-cholesterol concentrations at screening (130-190 mg/dL or 3.4-4.9\r\n             mmol/L).\r\n\r\n          -  Blood pressure, heart rate, haematological and clinical chemical parameters within the\r\n             normal reference range as judged by the research physician\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Having (previous) cardiovascular event(s) (stroke, TIA, angina, myocardial infarction,\r\n             heart failure), systemic inflammatory conditions or diabetes mellitus.\r\n\r\n          -  Use of over-the-counter and prescribed medication which may interfere with study\r\n             measurements (i.e. statins, ezetimibe, fibrates, diabetic drugs, ARB and ACE\r\n             inhibitors), to be judged by the Principal Investigator.\r\n\r\n          -  Use of medical treatment for elevated TG concentrations.\r\n\r\n          -  Use of antibiotics in the three months prior to screening.\r\n\r\n          -  Currently smoking or being a non-smoker for less than 6 months and reported use of any\r\n             nicotine containing products in the 6 months prior to screening and/or during the\r\n             study.\r\n      ","sponsor":"Unilever R&D","sponsor_type":"Industry","conditions":"Vascular Diseases|Hypercholesterolemia","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Plant Sterols"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Placebo Product"}],"outcomes":[{"outcome_type":"primary","measure":"Change in flow-mediated dilation","time_frame":"At baseline (after 4 weeks run-in period) and after 12 weeks intervention"},{"outcome_type":"secondary","measure":"Change in pulse wave velocity","time_frame":"At baseline (after 4 weeks run-in period) and after 12 weeks intervention"},{"outcome_type":"other","measure":"Change in blood lipids","time_frame":"At baseline (after 4 weeks run-in period) and after 4, 8 and 12 weeks intervention"},{"outcome_type":"other","measure":"Change in plasma plant sterols","time_frame":"At baseline (after 4 weeks run-in period) and after 4, 8 and 12 weeks intervention"},{"outcome_type":"other","measure":"Change in plasma biomarkers of endothelial dysfunction and low-grade inflammation","time_frame":"At baseline (after 4 weeks run-in period) and after 12 weeks intervention"},{"outcome_type":"other","measure":"Change in aortic augmentation index","time_frame":"At baseline (after 4 weeks run-in period) and after 12 weeks intervention"},{"outcome_type":"other","measure":"Change in central blood pressure","time_frame":"At baseline (after 4 weeks run-in period) and after 12 weeks intervention"},{"outcome_type":"other","measure":"Change in office blood pressure","time_frame":"At baseline (after 4 weeks run-in period) and after 12 weeks intervention"}]}
{"nct_id":"NCT01772966","start_date":"2013-02-28","phase":"N/A","enrollment":319,"brief_title":"Chiropractic Manual Therapy and Neck Pain","official_title":"Generalizing a Valid Control Manipulation to a Multiple Operator, Longitudinal Randomized Controlled Study for Chronic Neck Pain","primary_completion_date":"2016-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-08-31","last_update":"2016-10-31","description":"Eligible subjects with chronic neck pain will be randomly allocated to one of two intervention groups: real vs control spinal manipulation. They will receive three intervention sessions. H1: Chronic neck pain patients treated longitudinally over a series of three encounters in one week by random assignment to treatment group with either of the dual delivery procedures (Intervention 1=typical-control or Intervention 2=control-control) will have a 50% error rate of self-report of group allocation at exit interview. H2: Patients treated by the typical-control dual procedure over a typical sequence of encounters (3 times in one week) will show statistically significant improvement in clinical outcomes; defined quantitatively by visual analogue pain scale (VAS), Neck Disability Index (NDI), range of motion and pressure algometry; compared to those treated by the control-control dual procedure. H3: Patients stratified by 'a priori' patient expectation for treatment outcome will show no significant difference in self-report of group allocation or clinical outcome measures. A total of 372 subjects will be recruited.","other_id":"122008","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":21,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or Female\r\n\r\n          -  21 to 60 years of age\r\n\r\n          -  Chronic neck pain\r\n\r\n          -  Neck pain duration greater than 6 weeks\r\n\r\n          -  Numeric Rating Scale greater than 30, less than 65\r\n\r\n          -  Pain distribution between nuchal ridge and spine of the scapula\r\n\r\n          -  Pain aggravated by local provocation maneuvers at single motion segment\r\n\r\n          -  Antero-posterior glide\r\n\r\n          -  Paraspinal tenderness\r\n\r\n          -  Negative provocative maneuvers at adjacent segment\r\n\r\n          -  Able to tolerate neck movement to 50 percent normal in all directions\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Worker's compensation or other medico-legal claim\r\n\r\n          -  Cervical spine surgery or fracture or dislocation\r\n\r\n          -  Uncontrolled hypertension (Blood Pressure over 140 over 90)\r\n\r\n          -  Stroke or Transient Ischemic Attack\r\n\r\n          -  Upper respiratory infection within 4 weeks\r\n\r\n          -  Severe degenerative disease of the cervical spine\r\n\r\n          -  New or significantly altered pattern of headache complaint\r\n\r\n          -  Connective tissue disease\r\n\r\n          -  Primary fibromyalgia\r\n\r\n          -  Metabolic or metaplastic bone disease\r\n\r\n          -  Whiplash injury within 12 months\r\n\r\n          -  High cholesterol levels not well-managed medically\r\n\r\n          -  Cardiovascular surgery in the past 6 months or planned\r\n\r\n          -  Use of narcotic analgesic, prescription anti-inflammatory, or muscle relaxants,\r\n             anti-convulsants\r\n\r\n          -  Angina pectoris\r\n\r\n          -  Dizziness\r\n\r\n          -  Tinnitus\r\n\r\n          -  Blurred vision, vertigo, undiagnosed sensory and motor disturbances\r\n\r\n          -  Radicular symptoms and signs\r\n\r\n          -  Current use of anticoagulant therapy\r\n\r\n          -  Upper respiratory infection\r\n\r\n          -  Neck pain on provocation greater than 7 out of 10\r\n\r\n          -  Provocation of radicular pain or sensory disturbance\r\n\r\n          -  Hypermobility of multiple peripheral joints,\r\n\r\n          -  Physical or mental impairment precluding following instructions or participating -in\r\n             supine recumbent postures\r\n      ","sponsor":"Canadian Memorial Chiropractic College","sponsor_type":"Other","conditions":"Chronic Mechanical Neck Pain","interventions":[{"intervention_type":"Procedure","name":"Procedure: Spinal manipulation"}],"outcomes":[{"outcome_type":"primary","measure":"Group registration","time_frame":"At exit assessment following the third intervention session","description":"Participants will be asked to identify which of the two interventions they feel they received."},{"outcome_type":"secondary","measure":"Pain severity","time_frame":"1. at baseline, and 2. At exit assessment following the third intervention session","description":"Pain scores on the PROMIS pain severity instrument."},{"outcome_type":"secondary","measure":"Improvement","time_frame":"At exit assessment following the third intervention session","description":"Participants will be asked to rate their level of improvement on the The Global Rating of Change instrument."},{"outcome_type":"secondary","measure":"Disability","time_frame":"1. at baseline, and 2. At exit assessment following the third intervention session","description":"Participants will score the The Neck Disability Index (score out of 50)."},{"outcome_type":"secondary","measure":"Tenderness","time_frame":"1. at baseline, and 2. At exit assessment following the third intervention session","description":"Pressure algometry over a single specified spinal site will be used to measure tenderness in kg/sq.sm."},{"outcome_type":"other","measure":"Number of Participants with Adverse Events as a Measure of Safety","time_frame":"Daily over 7-10 days.","description":"All adverse events will be described and tallied. Adverse events will be categorized in two modes: 1] Serious vs. Not Serious, and, 2] Attributable to the trial vs. Not Attributable. Both the absolute number of adverse events as well as the percentage of subjects experiencing an adverse event will be reported."},{"outcome_type":"other","measure":"Expectations related to improvement","time_frame":"Baseline","description":"Participants' expectations of the efficacy of the interventions will be obtained at baseline with the protocol of Fulda et al."}]}
{"nct_id":"NCT01788475","start_date":"2013-02-22","phase":"N/A","enrollment":3,"brief_title":"Safety and Effectiveness of Ozurdex Steroid Implants for DME After Vitrectomy Surgery","official_title":"A Randomized, Pilot Study of the Efficacy and Safety of Ozurdex Steroid Implants in Post-Vitrectomized Eyes in Patients With Diabetic Macular Edema","primary_completion_date":"2014-11-30","study_type":"Interventional","rec_status":"Terminated","completion_date":"2014-11-12","last_update":"2020-03-12","description":"Currently medications injected intravitreally in previously vitrectomized eyes have a very short half-life due to enhanced clearance of the drug. The use of the Ozurdex (dexamethasone) implant may allow sustained levels of steroid delivery to patients with diabetic macular edema that have undergone prior vitrectomy. The sustained steroid levels may lead to improved central retinal thickness measurements and improved visual acuity.","other_id":"2012-031","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Adults> 18 years of age with type 1 or 2 diabetes mellitus\r\n\r\n          2. Patients with DME secondary to diabetes mellitus involving the center of the macula\r\n             OCT thickness is > 300 microns with intraretinal cystic edema\r\n\r\n          3. BCVA between 20/40 to 20/400\r\n\r\n          4. Patient had vitrectomy surgery.\r\n\r\n          5. Provide a signed informed consent prior to any study procedure\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patient unlikely to benefit from intravitreal Ozurdex due to macular ischemia,\r\n             atrophy, or other condition\r\n\r\n          2. Patient with history of steroid response with IOP >35 mm Hg or requirement to be on >\r\n             2 glaucoma medications following previous steroid injection.\r\n\r\n          3. Previous injection of anti-VEGF or steroid in the study eye within 90 days\r\n\r\n          4. Vitrectomy, cataract surgery, or YAG capsulotomy within 90 days.\r\n\r\n          5. Current tractional detachment of the macula or vitreous hemorrhage obscuring details\r\n             of the macula.\r\n\r\n          6. Pregnant, lactating females, or females of child-bearing potential that are not using\r\n             reliable contraception.\r\n      ","sponsor":"Lahey Clinic","sponsor_type":"Other","conditions":"Diabetic Macular Edema","interventions":[{"intervention_type":"Drug","name":"Drug: Dexamethasone","description":"Ozurdex (dexamethasone) 0.7mg steroid implant"}],"outcomes":[{"outcome_type":"primary","measure":"Visual Acuity Gain","time_frame":"13 months","description":"Measured visual acuity gain in number of letters improved as a result of treatment"},{"outcome_type":"secondary","measure":"Central Retinal Thickness Reduction","time_frame":"1 year","description":"Central Retinal Thickness Reduction as measured by Heidelberg OCT"},{"outcome_type":"secondary","measure":"Comparison of Efficacy Between Group 1 and 2","time_frame":"3 years","description":"Comparison of efficacy between group 1 and group 2"},{"outcome_type":"secondary","measure":"Visual Acuity Gain at Year 2 and 3","time_frame":"3 years","description":"VA gain in ETDRS letters at years 2 and years 3"},{"outcome_type":"secondary","measure":"Time to Reimplantation of Ozurdex Implant","time_frame":"3 years","description":"Time in months until new implant is needed"}]}
{"nct_id":"NCT01740427","start_date":"2013-02-22","phase":"Phase 3","enrollment":666,"brief_title":"A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)","official_title":"A RANDOMIZED, MULTICENTER, DOUBLE-BLIND PHASE 3 STUDY OF PD-0332991 (ORAL CDK 4/6 INHIBITOR) PLUS LETROZOLE VERSUS PLACEBO PLUS LETROZOLE FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH ER (+), HER2 (-) BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTI CANCER TREATMENT FOR ADVANCED DISEASE","primary_completion_date":"2016-02-26","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2023-08-26","last_update":"2020-10-09","description":"The study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease.","other_id":"A5481008","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adult women with locoregionally recurrent or metastatic disease not amenable to\r\n             curative therapy.\r\n\r\n          -  Confirmed diagnosis of ER positive breast cancer\r\n\r\n          -  No prior systemic anti-cancer therapy for advanced ER+ disease.\r\n\r\n          -  Postmenopausal women\r\n\r\n          -  Measurable disease as per Response Evaluation Criterion in Solid Tumors [RECIST] or\r\n             bone-only disease\r\n\r\n          -  Eastern Cooperative Oncology Group [ECOG] 0-2\r\n\r\n          -  Adequate organ and marrow function\r\n\r\n          -  Patient must agree to provide tumor tissue\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Confirmed diagnosis of HER2 positive disease\r\n\r\n          -  Patients with advanced, symptomatic, visceral spread that are at risk of life\r\n             threatening complication in the short term\r\n\r\n          -  Known uncontrolled or symptomatic CNS metastases\r\n\r\n          -  Prior (neo)adjuvant treatment with letrozole or anastrozole with DFI  12-months from\r\n             completion of treatment.\r\n\r\n          -  Prior treatment with any CDK 4/6 inhibitor.\r\n      ","sponsor":"Pfizer","sponsor_type":"Industry","conditions":"Breast Neoplasms","interventions":[{"intervention_type":"Drug","name":"Drug: PD-0332991","description":"PD-0332991, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment"},{"intervention_type":"Drug","name":"Drug: Letrozole","description":"Letrozole, 2.5mg, orally once daily (continuously)"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment"},{"intervention_type":"Drug","name":"Drug: Letrozole","description":"Letrozole, 2.5mg, orally once daily (continuously)"}],"outcomes":[{"outcome_type":"primary","measure":"Progression-Free Survival (PFS) as Assessed by the Investigator.","time_frame":"From randomization date to date of first documentation of progression OR death (up to approximately 2.5 years)","description":"PFS is defined as the time from the date of randomization to the date of the first documentation of objective tumor progression as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) or death due to any cause in the absence of documented PD, whichever occurs first. If tumor progression data include more than 1 date, the first date will be used. PFS (in months) will be calculated as (first event date - randomization date +1)/30.4. Progression is defined using RECIST v1.1, as a 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions, or the appearance of new lesions."},{"outcome_type":"secondary","measure":"Objective Response as Assessed by the Investigator","time_frame":"From randomization until end of treatment (up to approximately 2.5 years)","description":"Objective Response (OR) is defined as the overall complete response (CR) or partial response (PR) according to the RECIST v1.1. Objective Response Rate (ORR) is defined as proportion of patients with CR or PR relative to all randomized patients with measurable disease at baseline. Patients who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment, or who died, progressed/ dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the assessment of ORR. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10mm). PR: ≥30% decrease under baseline of the sum of diameters of all target measurable lesions.The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. Stable Disease: neither sufficient shrinkage nor increase to qualify for disease progression."},{"outcome_type":"secondary","measure":"Objective Response: Patients With Measurable Disease at Baseline as Assessed by the Investigator","time_frame":"From randomization until end of treatment (up to approximately 2.5 years)","description":"The OR is defined as the overall CR or PR according to the RECIST v1.1. ORR is defined as proportion of patients with CR or PR relative to all randomized patients with measurable disease at baseline. Patients who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment, or who died, progressed/ dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the assessment of ORR. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10mm). PR: ≥30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. Stable Disease: neither sufficient shrinkage nor increase to qualify for disease progression."},{"outcome_type":"secondary","measure":"Duration of Response (DR)","time_frame":"From randomization until end of treatment (up to approximately 2.5 years)","description":"DR is defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurs first. If tumor progression data included more than 1 date, the first date will be used. DR was calculated as [the date response ended (i.e. date of PD or death) - first CR or PR date + 1)]/30.4. DR would only be calculated for the subgroup of patients with an objective tumor response. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10mm). PR: ≥30% decrease under baseline of the sum of diameters of all target measurable lesions.The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. Stable Disease: neither sufficient shrinkage nor increase to qualify for disease progression."},{"outcome_type":"secondary","measure":"Disease Control (DC)/Clinical Benefit Response (CBR)","time_frame":"From randomization until end of treatment (up to approximately 2.5 years)","description":"DC is defined as the overall CR, PR, or stable disease (SD) ≥24 weeks according to the RECIST version 1.1. Disease Control Rate (DCR) is defined as the patients with CR, PR, or SD ≥24 weeks relative to all randomized participants. Participants who do not have on-study radiographic tumor reevaluation, who received anti-tumor treatment, a best response of SD≥24 weeks, or who died, progressed,or dropped out for any reason prior to achieving reaching a CR or PR and a best response of SD≥24 weeks was counted as non-responders in DCR. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10mm). PR: ≥30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. SD: neither sufficient shrinkage nor increase to qualify for disease progression"},{"outcome_type":"secondary","measure":"Tumor Tissue Biomarkers, Including Genes (eg, Copy Numbers of CCND1, CDKN2A), Proteins (eg, Ki67, pRb), and RNA Expression (eg, cdk4, cdk6): Protein Biomarker Analyses by Using Immunohistochemistry Are Presented","time_frame":"From randomization until end of treatment (up to approximately 24 Months)","description":"PFS survival by biomarker status by Investigator assessment. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.\r\nPositive is defined as H-Score ≥1 and negative as H-Score <1. H-Score is calculated as the sum of the % of cells at each level of staining intensity (0, 1+, 2+, and 3+) multiplied by the staining intensity value: H-Score = (% at 0)*0 + (% at 1+)*1 + (% at 2+)*2 + (% at 3+)*3. H-Score values range from 0 to 300.\r\nER stands for estrogen receptor and Rb stands for retinoblastoma susceptibility gene product."},{"outcome_type":"secondary","measure":"Corrected QT Interval (QTc) Time-matched Change From Baseline on Cycle 1 Day 14","time_frame":"Time-matched triplicate ECGs were collected at 0 (predose), 2, 4, 6 and 8 hours on Day 0 and on Cycle1 Day14","description":"Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and sent to a central laboratory for blinded manual adjudication. The average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR), by Bazette's formula (QTcB = QT divided by square root of RR) and corrected QT interval according to study-specific criteria (QTcS). Time-matched change from baseline values were reported for QTc analysis population."},{"outcome_type":"secondary","measure":"Corrected QT Interval (QTc)","time_frame":"For safety monitoring triplicate ECGs were obtained at 0 hour (pre-dose) on Day 1 of Cycle 1, Day 14 of Cycles 1 and Cycle 2, then on Day 1 of Cycles 4, 7, and 10. ECGs beyond Cycle 10 were performed as clinically indicated","description":"Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and sent to a central laboratory for blinded manual adjudication. The average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR), by Bazette's formula (QTcB = QT divided by square root of RR) and corrected QT interval according to study-specific criteria (QTcS). Percentage of participants with post-baseline maximum absolute values and maximum increase from baseline were summarized for the safety analysis population."},{"outcome_type":"secondary","measure":"Observed Plasma Trough Concentration (Ctrough) at Steady-State","time_frame":"0 hour (predose) on Day 14 of cycles 1 and 2","description":"Summary of Plasma Palbociclib Within-Patient Mean Steady-State Trough Concentrations."},{"outcome_type":"secondary","measure":"Change From Baseline Between Treatment Comparison in Euro Quality of Life (EQ-5D) Index","time_frame":"From Baseline up to 2.5 years","description":"The EuroQol EQ-5D is a 6-item instrument designed to assess health status in terms of a single index value or utility score. It contains 5 descriptors of current health state (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with each dimension having 3 levels of function (1=no problem, 2=some problem, and 3=extreme problem). The scores on the 5 descriptors are summarized to create a single summary score. An overall utility score is calculated based on these domains, with a range score from 0 (worse health scenario) to a maximum of 1.0 (best health scenario)."},{"outcome_type":"secondary","measure":"Change From Baseline Between Treatment Comparison in Functional Assessment of Cancer Therapy -Breast (FACT-B)","time_frame":"From Baseline up to 2.5 years","description":"FACT is a modular approach to assess participant health-related quality of life using a 'core' set of questions (FACT-G) as well as a cancer site-specific module. The FACT-G is a 27-item compilation of general questions divided into 4 domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. The FACT-B consisted of the FACT-G (27-item) and a breast-specific module: a 10-item instrument designed to assess participant concerns relating to breast cancer. For all questions, participants were asked to respond to a five-level scale where 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. FACT-B total score = Physical Well-Being + Social/Family Well-Being + Emotional Well-Being + Functional Well-Being + Breast Cancer Subscale. As each of the items ranges from 0-4, the range of possible scores is 0-144, with 0 being the worst possible score and 144 the best."},{"outcome_type":"secondary","measure":"Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs; All Causalities)","time_frame":"From the participant randomization up to 28 days after last dose of study drug, up to 2.5 years","description":"An AE is any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is any untoward medical occurrence at any dose that results in death; is life-threatening; requires hospitalization; results in persistent or significant disability or in congenital anomaly/birth defect. Severity will be graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0."}]}
{"nct_id":"NCT01731600","start_date":"2013-02-20","phase":"Phase 3","enrollment":68,"brief_title":"A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Previously Treated Paediatric Patients With Severe Haemophilia A","official_title":"A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Previously Treated Paediatric Patients With Severe Haemophilia A","primary_completion_date":"2014-09-15","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-09-28","last_update":"2020-11-23","description":"This trial is conducted globally. The aim of the trial is to investigate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP) in children with severe haemophilia A who have undergone treatment with previous factor VIII (FVIII) products.","other_id":"NN7088-3885","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","maximum_age":11,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male patients with severe congenital haemophilia A (FVIII activity level below 1%)\r\n\r\n          -  Weight above or equal to 10 kg - Documented history of 150 exposure days (ED) to FVIII\r\n             products for patients aged 6-11 years and above 50 ED to FVIII products for patients\r\n             aged 0-5 years\r\n\r\n        Exclusion Criteria:\r\n\r\n        - Any history of FVIII inhibitors\r\n      ","sponsor":"Novo Nordisk A/S","sponsor_type":"Industry","conditions":"Congenital Bleeding Disorder|Haemophilia A","interventions":[{"intervention_type":"Drug","name":"Drug: turoctocog alfa pegol","description":"Fixed dose of turoctocog alfa pegol for intravenous injections (i.v.) twice weekly for prophylaxis. In addition, turoctocog alfa pegol will be administered to treat bleeding episodes during the trial period. Bleeding episodes will be treated with doses of 20-75 U/kg body weight."}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants With Inhibitory Antibodies Against Coagulation Factor VIII (FVIII) ≥0.6 Bethesda Units","time_frame":"During the main phase of the trial (from 0-26 weeks of treatment)","description":"The number of participants with inhibitory antibodies against coagulation factor VIII (FVIII) ≥0.6 Bethesda units was presented."},{"outcome_type":"secondary","measure":"Frequency of Adverse Events Including Serious Adverse Events Reported During the Trial Period","time_frame":"Main phase: (from 0-26 weeks of treatment) and full trial: (0 weeks to last patient's completion of the trial, an average of 4.5 years)","description":"The frequency of adverse events including serious adverse events reported during the main and extension phase of the trial. The data presented is the rate of AE i.e. number of AEs per patient years of exposue."},{"outcome_type":"secondary","measure":"Haemostatic Effect of N8-GP When Used for Treatment of Bleeding Episodes and Assessed as: Excellent, Good, Moderate, or None","time_frame":"Main phase: (from 0-26 weeks of treatment) and full trial: (0 weeks to last patient's completion of the trial, an average of 4.5 years)","description":"Haemostatic effect of N8-GP for treatment of bleeding episodes was assessed by 4-point response scale: none, moderate, good or excellent. Evaluation during trial was done by patient and/or parent(s)/caregiver 8 hours after first injection as follows: Excellent: Abrupt pain relief and/or clear improvement in objective signs of bleeding within approximately 8 hours after a single injection; Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after a single injection, but possibly requiring more than one injection for complete resolution; Moderate: Probable or slight beneficial effect within approximately 8 hours after the first injection, but usually requiring more than one injection; None: No improvement, or worsening of symptoms."},{"outcome_type":"secondary","measure":"Number of Bleeding Episodes During Prophylactic Treatment With N8-GP (Annualised Bleeding Rate)","time_frame":"Main phase: (from 0-26 weeks of treatment) and full trial: (0 weeks to last patient's completion of the trial, an average of 4.5 years)","description":"The number of bleeding episodes per year reported during the prophylactic treatment with N8-GP."},{"outcome_type":"secondary","measure":"Consumption of N8-GP Per Bleeding Episode (Number of Injections)","time_frame":"Main phase: (from 0-26 weeks of treatment) and full trial: (0 weeks to last patient's completion of the trial, an average of 4.5 years)","description":"The mean number of injections of N8-GP used for treatment of a bleed from start to stop of a bleed."},{"outcome_type":"secondary","measure":"Consumption of N8-GP Per Bleeding Episode (U/kg)","time_frame":"Main phase: (from 0-26 weeks of treatment) and full trial: (0 weeks to last patient's completion of the trial, an average of 4.5 years)","description":"The mean consumption of N8-GP used for treatment of a bleed from start to stop of a bleed."},{"outcome_type":"secondary","measure":"Consumption of N8-GP During Prophylaxis (Number of Injections)","time_frame":"Main phase: (from 0-26 weeks of treatment) and full trial: (0 weeks to last patient's completion of the trial, an average of 4.5 years)","description":"The mean number of injections of N8-GP used for treatment of a bleed from start to stop of a bleed during prophylaxis."},{"outcome_type":"secondary","measure":"Consumption of N8-GP During Prophylaxis (U/kg Per Month)","time_frame":"Main phase: (from 0-26 weeks of treatment) and full trial: (0 weeks to last patient's completion of the trial, an average of 4.5 years)","description":"The mean consumption of N8-GP used for treatment of a bleed from start to stop of a bleed during prophylaxis (per month per subject). Consumption used for treatment includes all doses given (prophylaxis, treatment of bleed, minor surgery and pharmacokinetics [PK])"},{"outcome_type":"secondary","measure":"Consumption of N8-GP During Prophylaxis (U/kg Per Year)","time_frame":"Main phase: (from 0-26 weeks of treatment) and full trial: (0 weeks to last patient's completion of the trial, an average of 4.5 years)","description":"The mean consumption of N8-GP used for treatment of a bleed from start to stop of a bleed during prophylaxis (per year per subject). Consumption used for treatment includes all doses given (prophylaxis, treatment of bleed, minor surgery and pharmacokinetics)"},{"outcome_type":"secondary","measure":"Incremental Recovery (Defined as the Peak Level Recorded 60 Min After End of Injection) Evaluated for Previous FVIII Product","time_frame":"2-6 weeks prior to initial dosing with N8-GP and up to 30 hours after administration of previous FVIII product","description":"The incremental recovery was defined as the increase in plasma FVIII activity per IU/kg of factor administered recorded 60 minutes after end of injection. It was calculated as (Factor VIII procoagulant [FVIII:C] activity measured in plasma 60 min after dosing - FVIII:C activity measured in plasma immediately before dosing) / (dose injected at time 0 min), where the dose was expressed as U FVIII product per kg body weight. A chromogenic assay with normal human plasma (NHP) as calibrator was used."},{"outcome_type":"secondary","measure":"Incremental Recovery (Defined as the Peak Level Recorded 60 Min After End of Injection) Evaluated for N8-GP","time_frame":"From 1 hour prior to and up to 96 hours after initial administration of N8-GP","description":"The incremental recovery was defined as the peak level recorded 60 min after end of injection and dose-normalised. It was calculated as (FVIII:C activity measured in plasma 60 min after dosing - FVIII:C activity measured in plasma immediately before dosing) / (dose injected at time 0 min), where the dose was expressed as U FVIII product per kg body weight. A chromogenic assay with product specific calibrator (PSS) as calibrator was used."},{"outcome_type":"secondary","measure":"Area Under the Curve Evaluated for Previous FVIII Product","time_frame":"2-6 weeks prior to initial dosing with N8-GP and up to 30 hours after administration of previous FVIII product","description":"Area under the curve (AUC) versus time from zero to infinity. This is calculated as AUC = AUClast + (C(t) / λz), where C(t) is the last measurable concentration. A chromogenic assay with NHP as calibrator was used."},{"outcome_type":"secondary","measure":"Area Under the Curve Evaluated for N8-GP","time_frame":"From 1 hour prior to and up to 96 hours after initial administration of N8-GP","description":"Area under the curve versus time from zero to infinity. This is calculated as AUC = AUClast + (C(t) / λz), where C(t) is the last measurable concentration. A chromogenic assay with product specific standard (PSS) as calibrator was used."},{"outcome_type":"secondary","measure":"Terminal Half-life Evaluated for Previous FVIII Product","time_frame":"2-6 weeks prior to initial dosing with N8-GP and up to 30 hours after administration of previous FVIII product","description":"t½ = ln(2) / λz, where t½ is terminal half-life and λz is the terminal elimination rate. The terminal elimination rate was planned estimated using linear regression on the terminal part of the time versus log(concentration) curve. A population-based method simultaneously estimating individual t½ values for all patients was applied, including patients with few values above the lower limit of quantification (LLOQ). This was estimated using time points from 1h to 30h. A chromogenic assay with PSS as calibrator was used."},{"outcome_type":"secondary","measure":"Terminal Half-life Evaluated for N8-GP","time_frame":"From 1 hour prior to and up to 96 hours after initial administration of N8-GP","description":"t½ = ln(2) / λz, where λz is the terminal elimination rate. The terminal elimination rate was planned estimated using linear regression on the terminal part of the time versus log(concentration) curve. A population-based method simultaneously estimating individual t½ values for all patients was applied, including patients with few values above the LLOQ. This was estimated using time points from 6h to 96h. A chromogenic assay with PSS as calibrator was used."},{"outcome_type":"secondary","measure":"Clearance Evaluated for Previous FVIII Product","time_frame":"2-6 weeks prior to initial dosing with N8-GP and up to 30 hours after administration of previous FVIII product","description":"Total plasma clearance of drug after intravenous administration measured as actual dose/AUC. A chromogenic assay with NHP as calibrator was used."},{"outcome_type":"secondary","measure":"Clearance Evaluated for N8-GP","time_frame":"From 1 hour prior to and up to 96 hours after initial administration of N8-GP.","description":"Total plasma clearance of drug after intravenous administration measured as actual dose/AUC. A chromogenic assay with PSS as calibrator was used."}]}
{"nct_id":"NCT01776034","start_date":"2013-01-31","phase":"Phase 1","enrollment":45,"brief_title":"Health Promotion and Wellness Program for Stroke Survivors","official_title":"Examining the Efficacy of a SystemCHANGE Weight Management Intervention in Stroke Survivors","primary_completion_date":"2017-07-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2017-07-31","last_update":"2016-07-13","description":"The objective of this study is to conduct a randomized controlled pilot study to examine the efficacy, feasibility and safety of the SystemCHANGE health promotion and wellness program in stroke survivors. The central hypothesis of the study is that the SystemCHANGE program will help overweight and obese stroke survivors engaging in healthy behaviors, thereby improving health and function.","other_id":"07-14-16","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":30,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  physician-confirmed unilateral ischemic or hemorrhagic stroke\r\n\r\n          -  at least 6 weeks post-stroke\r\n\r\n          -  physician consent to participate\r\n\r\n          -  BMI between 25 to 40 kg/m2\r\n\r\n          -  stable weight for the past 4 weeks\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  heart disease (i.e., myocardial infarction, congestive heart failure, coronary artery\r\n             bypass grafting or valve replacement during the past 3 months, serious cardiac\r\n             arrhythmias, hypertrophic cardiomyopathy, and severe aortic stenosis)\r\n\r\n          -  pulmonary embolus,\r\n\r\n          -  uncontrolled blood pressure (i.e., 140/90 mmHg) or diabetes (fasting blood sugar\r\n             levels > 125 mg/dl)\r\n\r\n          -  unable to communicate\r\n\r\n          -  severe cognitive deficits\r\n\r\n          -  pregnancy\r\n\r\n          -  three or more falls in the past month,\r\n\r\n          -  inability to walk 3 meters with or without a mobility device,\r\n\r\n          -  weight loss medications or medications that cause weight gain (i.e., corticosteroids\r\n             and antipsychotic),\r\n\r\n          -  gastric bypass surgery\r\n      ","sponsor":"Case Western Reserve University","sponsor_type":"Other","conditions":"Stroke","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: SystemCHANGE Group Lifestyle counseling"},{"intervention_type":"Behavioral","name":"Behavioral: Phone Lifestyle Counseling"}],"outcomes":[{"outcome_type":"primary","measure":"Changes from baseline in body weight and percent body fat","time_frame":"Each patient will be given the assessments at 3 points during the study, at baseline, interim test (an average of 3 months from baseline) and at posttest (an average of 6 months from baseline).","description":"body weight and percent body fat will be measured with the Bod Pod"},{"outcome_type":"primary","measure":"Changes from baseline in patient-reported quality of life","time_frame":"Each patient will be given the assessments at 3 points during the study, at baseline, interim test (an average of 3 months from baseline) and at posttest (an average of 6 months from baseline).","description":"Stroke Impact Scale and Reintegration to Normal Living Index will be administered."},{"outcome_type":"primary","measure":"Changes from baseline in physical function","time_frame":"Each patient will be given the assessments at 3 points during the study, at baseline, interim test (an average of 3 months from baseline) and at posttest (an average of 6 months from baseline).","description":"6-Minute Walking Test and Rivermead Motor Assessment will be conducted."},{"outcome_type":"secondary","measure":"Changes from baseline in biomarkers.","time_frame":"Each patient will be given the assessments at 3 points during the study, at baseline, interim test (an average of 3 months from baseline) and at posttest (an average of 6 months from baseline).","description":"Blood draws will be performed for cholesterol, triglycerides, C-reactive protein, and hemoglobin A1c."},{"outcome_type":"secondary","measure":"Changes from baseline in healthy behaviors and psychosocial mediators","time_frame":"Each patient will be given the assessments at 3 points during the study, at baseline, interim test (an average of 3 months from baseline) and at posttest (an average of 6 months from baseline).","description":"A three-day food diary, the Physical Activity and Disability Survey, and sleep quality measured with the Patient-Reported Outcomes Measurement Information System (PROMIS)will be administered. Potential psychosocial mediators that will be measured include self-efficacy for diet, physical activity, and self-management, and social support for healthy behaviors."}]}
{"nct_id":"NCT01647334","start_date":"2013-01-31","phase":"N/A","enrollment":29,"brief_title":"Shrinking Target Adaptive Radiotherapy for Locally Advanced Non-Small Cell Lung Cancer","official_title":"Shrinking Target Adaptive Radiotherapy for Locally Advanced Non-Small Cell Lung Cancer","primary_completion_date":"2014-12-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2014-12-31","last_update":"2015-02-19","description":"This study aims to use a type of radiation (adaptive radiotherapy) to deliver curative-intent treatment to patients with non-small cell lung cancer, whose tumors would otherwise be too large for standard curative treatment. The study will use adaptive radiotherapy to achieve these goals. Adaptive radiotherapy is a process whereby treatment plans are modified during the course of treatment due to patient and tumor variations (ie. weight loss or tumor shrinkage). This may allow for dose escalation, while limiting the side effects.","other_id":"Lung-START","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age 18 or older\r\n\r\n          -  Willing to provide informed consent\r\n\r\n          -  ECOG performance status 0-2\r\n\r\n          -  Histologically confirmed non-small cell lung carcinoma\r\n\r\n          -  Locally advanced stage IIIA or IIIB lung carcinoma according to AJCC 7th edition\r\n\r\n          -  Expected lung V20 of 35-60%, as determined at the time of 4D-CT simulation\r\n\r\n          -  Assessment by medical oncologist and radiation oncologist, with adequate hepatic and\r\n             renal function for administration of cisplatin-based doublet chemotherapy, at the\r\n             discretion of the medical oncologist\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Serious medical comorbidities or other contraindications to radiotherapy or\r\n             chemotherapy\r\n\r\n          -  Prior history of lung cancer within 5 years\r\n\r\n          -  Prior thoracic radiation at any time\r\n\r\n          -  Metastatic disease\r\n\r\n          -  in some select cases, patients with a solitary metastasis (i.e. brain metastasis) may\r\n             receive radical chemoradiotherapy after resection/ablation of their metastatic lesion,\r\n             as standard practice. In such cases, the patient may be enrolled onto this study at\r\n             the discretion of the local principle investigator once the metastasis has been\r\n             treated.\r\n\r\n          -  inability to attend full course of radiotherapy of follow-up visits\r\n\r\n          -  Pregnant or lactating women\r\n      ","sponsor":"Lawson Health Research Institute","sponsor_type":"Other","conditions":"Non Small Cell Lung Cancer","interventions":[{"intervention_type":"Radiation","name":"Radiation: Adaptive radiotherapy"}],"outcomes":[{"outcome_type":"primary","measure":"Tumor reduction","time_frame":"2.5 years (end of treatment)"},{"outcome_type":"secondary","measure":"Rate of tumor shrinkage","time_frame":"2.5 years (end of treatment)"},{"outcome_type":"secondary","measure":"Change in lung dose","time_frame":"2.5 years (end of treatment)"},{"outcome_type":"secondary","measure":"Delivered doses","time_frame":"2.5 years (end of treatment)"},{"outcome_type":"secondary","measure":"Radiation pneumonitis rates","time_frame":"6 months, 12 months, 18 months, 24 months, 30 months (semi-annually)"},{"outcome_type":"secondary","measure":"Local control","time_frame":"2.5 years (end of treatment)"},{"outcome_type":"secondary","measure":"Overall survival","time_frame":"2.5 years"}]}
{"nct_id":"NCT02864238","start_date":"2013-01-31","enrollment":2401,"brief_title":"The Utility of Clinical Milestones Pathway in a Cardiovascular ICU","official_title":"The Utility of an Electronic Based Milestone Pathway on the Care of Patients Undergoing Cardiac Valve Surgery","primary_completion_date":"2014-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2014-12-31","last_update":"2016-08-12","description":"The economic burden of health care is becoming a greater burden from year to year. Medicare spending, which represented 20 percent of national health spending in 2013, grew 3.4 percent to $585.7 billion, a slowdown from growth of 4.0 percent in 2012. This slowdown was attributed largely to slower enrollment growth and impacts of the Affordable Care Act (ACA) and sequestration. Per-enrollee spending in 2013 grew at about the same rate as 2012. The push to create Accountable Care Organizations (ACO) has taken these initiatives a step further. The goal would be to move away from a fee for service system and base reimbursement on quality of care. Clinical metrics, re-admissions, and patient satisfaction in categories of acute myocardial infarction, congestive heart failure, pneumonia, surgeries and healthcare associated infections will be the foci for 2013. Centers for Medicare and Medicaid Services (CMS) has also initiated a valve bundled payment system that encompasses total patient care for 90 days, including readmissions. Leapfrog and the ACO movement along with the nonprofit group Institute for Health Care Improvement have placed quality and cost effectiveness into the spotlight for clinicians in the ICU and beyond. While clinicians have always been focused on evidence based therapies with little concern for cost, in the new era of healthcare understanding cost, value and effectiveness of therapies will be key for improved patient outcomes and institutional solvency in trying economic times. Vanderbilt elected to enroll in the CMS valve bundle trial. The Leadership team in the heart and vascular institute identified the importance of an electronic medical record that includes display and utilization of key drivers of quality and success across the continuum of care (Preoperative assessment to discharge up to 90 days) in the bundled payment model of care. A multidisciplinary team was developed in conjunction with nurses, midlevel providers, multi-specialty physicians, case managers, informatics specialists, and performance improvement representatives to develop an electronic pathway of care using evidence based and best practices for cardiac surgery.","other_id":"IRB #151566","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":16,"population":"All patients who underwent cardiac valve surgery at vanderbilt university medical center\r\n        between 1/1/2013 and 12/31/2014","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Underwent cardiac valve surgery at vanderbilt university medical center between\r\n             1/1/2013 and 12/31/2014\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  none\r\n      ","sponsor":"Vanderbilt University","sponsor_type":"Other","conditions":"Cardiac Surgery","interventions":[{"intervention_type":"Other","name":"Other: electronic milestone pathway","description":"an electronic based, clinical milestone driven pathway developed to guide the care of cardiac valve surgery patients."}],"outcomes":[{"outcome_type":"primary","measure":"mortality","time_frame":"Post operative day 0 to post operative day 7","description":"mortality rate for patients during index hospitalization"},{"outcome_type":"secondary","measure":"Re-intubation rate within 48 hours","time_frame":"48 hours of index procedure","description":"re-intubation rate within 48 hours of index procedure for patients undergoing cardiac surgery"},{"outcome_type":"secondary","measure":"Acute Kidney Injury as defined by KDIGO (Kidney Disease Improving Global Outcomes) guidelines","time_frame":"All time points occurring between post operative day 0 and Post operative day 7","description":"Incidence of acute Kidney Injury as defined by KDIGO (Kidney Disease Improving Global Outcomes) guidelines during index hospitalization"},{"outcome_type":"secondary","measure":"Delirium","time_frame":"All time points occurring between post operative day 0 and Post operative day 7","description":"Incidence of delirium as defined by Intensive Care Unit Confusion Assessment Method (ICU-CAM) scoring system during index hospitalization"},{"outcome_type":"secondary","measure":"major adverse cardiac events","time_frame":"All time points occurring between post operative day 0 and Post operative day 7","description":"Incidence of major adverse cardiac events defined as death, need for re-operation, myocardial infarction during index hospitalization"},{"outcome_type":"secondary","measure":"Infection rates","time_frame":"All time points occurring between post operative day 0 and Post operative day 7","description":"defined as Catheter Associated Urinary Tract Infection (CAUTI), Central Line Associated Blood Stream Infection (CLABSI), sternal wound infection during index hospitalization"},{"outcome_type":"secondary","measure":"Direct cost","time_frame":"All time points occurring between post operative day 0 and Post operative day 7","description":"summation of costs directly attributable to patient care during index hospitalization"},{"outcome_type":"secondary","measure":"total cost","time_frame":"All time points occurring between post operative day 0 and Post operative day 7","description":"summation of costs directly attributable to patient care, as well as costs to the patient which are not directly attributable to patient care (unspecified charges to patient such as OR utilization fees, laboratory staff fees, etc.)"},{"outcome_type":"secondary","measure":"variance in cost","time_frame":"All time points occurring between post operative day 0 and Post operative day 7","description":"total and direct costs attributable to each patient undergoing cardiac valve surgery will be averaged for all patients undergoing cardiac valve surgery during the study period. Each individual patient's direct and total costs will then be compared to the averaged cost for all patients undergoing cardiac valve surgery hospitalization to obtain a variance in cost for each individual patient undergoing cardiac valve surgery. The investigators will then compare average variance between the two cohorts."}]}
{"nct_id":"NCT01792414","start_date":"2013-01-31","phase":"N/A","enrollment":70,"brief_title":"Transcranial Electrical Stimulation (TES) for the Treatment of Depression.","primary_completion_date":"2016-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-12-31","last_update":"2017-02-02","description":"This study is a RCT of transcranial electrical stimulation in depressed patients. Mood, cognitive test performance and biomarkers will be measured during the trial.","other_id":"HC12143","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  DSM-IV Major Depressive Episode (as part of a Major Depressive Disorder or Bipolar\r\n             Disorder), of minimum 4 weeks duration.\r\n\r\n          -  MADRS score  20 at study entry.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  DSM-IV psychotic disorder;\r\n\r\n          -  drug or alcohol abuse or dependence (preceding 12 months);\r\n\r\n          -  inadequate response to ECT (current episode of depression);\r\n\r\n          -  anticonvulsant or benzodiazepine medication;\r\n\r\n          -  rapid clinical response required, e.g. high suicide risk; clinically defined\r\n             neurological disorder or insult;\r\n\r\n          -  metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash)\r\n             at proposed electrode sites;\r\n\r\n          -  pregnancy.\r\n      ","sponsor":"The University of New South Wales","sponsor_type":"Other","conditions":"Major Depression","interventions":[{"intervention_type":"Device","name":"Device: Sham TES","description":"Neuroconn Eldith device"},{"intervention_type":"Device","name":"Device: Active TES","description":"Neuroconn Eldith device"}],"outcomes":[{"outcome_type":"primary","measure":"Montgomery Asberg Depression Rating Scale for Depression (MADRS)","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"Beck Depression Inventory II","time_frame":"12 weeks"}]}
{"nct_id":"NCT01952652","start_date":"2013-01-31","phase":"Phase 4","enrollment":61,"brief_title":"Naproxen Codeine in Arthroscopic Surgery","official_title":"Comparison of Post-operative Analgesic Effects of Naproxen Sodium and Naproxen Sodium-codeine Phosphate Administered Preemptively for Arthroscopic Meniscus Surgery","primary_completion_date":"2013-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-07-31","last_update":"2013-09-30","description":"In this study, the aim is to compare the efficacy of single dose naproxen sodium and combination of naproxen sodium-codeine phosphate on post-operative pain in adult patients undergoing arthroscopic menisectomy.Pre-emptive oral naproxen-codeine may be safely and more advantageous than naproxen alone.","other_id":"KA12/268","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients undergoing arthroscopic meniscectomy were included in the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -   18 years of age\r\n\r\n          -  hypersensitivity to non-steroidal anti-inflammatory drugs and codeine,\r\n\r\n          -  history of peptic ulcer, gastritis, upper gastrointestinal bleeding\r\n\r\n          -  coagulation disorder\r\n\r\n          -  serious hepatic and renal impairment\r\n\r\n          -  pregnancy\r\n\r\n          -  long-term NSAID and opioid use\r\n      ","sponsor":"Baskent University","sponsor_type":"Other","conditions":"Arthroscopic Meniscus Surgery","interventions":[{"intervention_type":"Drug","name":"Drug: Group N:Naproxen sodium","description":"drug will be given 60 minutes before surgery"},{"intervention_type":"Drug","name":"Drug: Group NC :naproxen sodium codeine phosphate","description":"drug will be given 60 minutes before surgery"}],"outcomes":[{"outcome_type":"primary","measure":"Pain scores as measured by Visual Analogue Scale were significantly lower in Group Naproxen codeine (group NC) at all time points compared to Group Naproxen (group N) in 61 patients who underwent arthroscopic meniscus surgery.","time_frame":"postoperative 18 hours","description":"patients will be followed postoperatively 18 hours for pain levels"}]}
{"nct_id":"NCT01715181","start_date":"2013-01-31","phase":"N/A","enrollment":75,"brief_title":"Volunteers Adding Life in Dementia: VALID","official_title":"A Cluster-Randomized Controlled Trial Evaluating the Effects of a Volunteer-Led Nonpharmacological Intervention to Reduce Neuropsychiatric Symptoms of Dementia in Long-Term Care Residents","primary_completion_date":"2015-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-03-31","last_update":"2017-04-14","description":"Older adults with Alzheimer's disease and other forms of dementia frequently develop challenging neuropsychiatric symptoms (NPS) as a result of their illness. Non-pharmacological strategies to manage these symptoms such as music, exercise, and participating in pleasant social events have been demonstrated to be safe and effective strategies to reduce these behavioral symptoms. Our project, Volunteers Adding Life in Dementia (VALID), will design and implement a volunteer-led program to reduce behavioral symptoms and improve the quality of life of older adults with dementia who are residing in long-term care facilities.","other_id":"VALIDII","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  diagnosis of Alzheimer's disease or related forms of dementia\r\n\r\n          -  significant symptoms of agitation as measured by a Cohen-Mansfield Agitation Inventory\r\n             (CMAI) total score of >39\r\n\r\n          -  resident in LTC facility for at least 30 days\r\n\r\n          -  presence of a caregiver or substitute decision maker willing to consent to treatment\r\n\r\n          -  no changes in psychotropic medications in the 2 weeks preceding enrolment in study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  depressive symptoms presenting acute risk (i.e. suicidal ideation)\r\n\r\n          -  physically aggressive behavior posing safety risk to others\r\n\r\n          -  uncontrolled pain\r\n\r\n          -  currently receiving palliative care\r\n\r\n          -  medically unstable with life expectancy of < 6 months\r\n\r\n          -  currently awaiting transfer to another LTC facility or hospital\r\n      ","sponsor":"Queen's University","sponsor_type":"Other","conditions":"Dementia|Alzheimer's Disease","interventions":[{"intervention_type":"Other","name":"Other: Volunteer visits","description":"Volunteers will visit 3 times per week with a visit duration of 30 minutes for each visit during the study."}],"outcomes":[{"outcome_type":"primary","measure":"Change in neuropsychiatric symptoms (measured by the Cohen-Mansfield Agitation Inventory)","time_frame":"Baseline, weeks 2,4,6,8 and 12"},{"outcome_type":"secondary","measure":"Change in Neuropsychiatric Inventory score","time_frame":"Baseline, weeks 4, 8, 12"},{"outcome_type":"secondary","measure":"Change in Cornell Depression in Dementia Rating Scale score","time_frame":"Baseline, weeks 4, 8, 12"},{"outcome_type":"secondary","measure":"Change in Dementia Quality of Life Scale (DEMQoL) score","time_frame":"Baseline, weeks 4, 8, 12"},{"outcome_type":"secondary","measure":"Change in Clinical Global Impression of Change (CGI-C)score","time_frame":"12 weeks"},{"outcome_type":"other","measure":"Modified nursing care assessment scale (M-NACS)","time_frame":"Baseline, week 12"},{"outcome_type":"other","measure":"Short Form Health Survey","time_frame":"Baseline, week 12","description":"Assessment of volunteer quality of life"}]}
{"nct_id":"NCT01861457","start_date":"2013-01-31","phase":"N/A","enrollment":39,"brief_title":"Reduction of Staph Aureus Carriage by Non-Antibiotic NOZIN Nasal Sanitizer Antiseptic","official_title":"Reduction of Staph Aureus Carriage by Non-Antibiotic NOZIN Nasal Sanitizer","primary_completion_date":"2013-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-05-31","last_update":"2015-04-22","description":"The purpose of this study is to determine the extent to which bacterial growth in the nostrils by S. aureus, a common bacteria that is found in hospital environment, can be reduced by NOZIN Nasal Sanitizer antiseptic nasal swabs during the course of a typical 10-hour work period in participants known to have S. aureus in their nose passages.","other_id":"Nozin","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  All healthy health care professionals between the ages of 18 and 60 years of age who\r\n             are regular full-time employees of the MUSC Hospital, work a 10 or 12 hour work shift,\r\n             and test positive for nasal vestibular S. aureus carriage within 10 days prior to\r\n             their scheduled study day will be eligible to participate in the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Excluded from the study will be individuals exhibiting symptoms of upper respiratory\r\n             disease, including chronic rhinitis/sinusitis, seasonal allergies, upper respiratory\r\n             infection during the previous four weeks, have known allergy to citrus or soy oil, or\r\n             are \"smokers\". \"Non-smokers\" will be defined as those individuals who have abstained\r\n             from smoking for at least one year prior to the study. Subjects must be able and agree\r\n             to refrain from using prescription and non-prescription nasal spray or other nasal\r\n             preparations or washes from the time of their screening up to and during their\r\n             scheduled study day.\r\n      ","sponsor":"Medical University of South Carolina","sponsor_type":"Other","conditions":"Infectious Disease","interventions":[{"intervention_type":"Other","name":"Other: Nozin Nasal Sanitizer","description":"The treatment agent tested was the alcohol and natural oil preparation that comprises the commercially available over-the-counter (OTC) product, NOZIN Nasal Sanitizer antiseptic, by Global Life Technologies Corp, with the addition of benzalkonium chloride (0.13%), as described for the patented and safety-tested formulation."},{"intervention_type":"Other","name":"Other: Placebo","description":"The placebo preparation, utilized to account for the potential mechanical effects of the application process, was phosphate buffered saline (PBS)."}],"outcomes":[{"outcome_type":"primary","measure":"Treatment-associated Change in S. Aureus Colonization During a Typical 10-hour Work Day","time_frame":"10-hour work day","description":"The percent change from morning baseline sample to the evening sample taken at the end of a typical 10-hour workday in treated subjects known to be colonized by Staph aureus."},{"outcome_type":"secondary","measure":"Treatment-associated Change in Total Nasal Bacterial Colonization During a Typical 10-hour Work Day","time_frame":"10 hour workday","description":"The percent change from morning baseline sample to the evening sample taken at the end of a typical 10-hour workday in treated subjects known to be colonized by Staph aureus."}]}
{"nct_id":"NCT01588379","start_date":"2013-01-31","phase":"N/A","enrollment":152,"brief_title":"Mothers and Girls Dancing Together Trial","official_title":"Effects of an Afro-centric Dance Program for African-American Daughters and Mothers","primary_completion_date":"2014-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-08-31","last_update":"2016-12-06","description":"The purpose of this study is to examine the feasibility and efficacy of a 12-week afterschool afro-centric dance physical activity program for daughters and mothers on the physical activity level of African-American girls.","other_id":"2010-0804","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":7,"maximum_age":11,"population":"","criteria":"\n        Inclusion Criteria for Girls:\r\n\r\n          -  7 -10 yrs old on the date of randomization\r\n\r\n          -  Defined as African-American if her parent/guardian identifies her as such\r\n\r\n          -  No inclusion criteria will be used for mothers\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Unable to wear the activity monitor\r\n\r\n          -  Unable to participate in physical activity, require oxygen supplementation for\r\n             exertion, have a developmental or physical disability preventing participation, cannot\r\n             increase their physical activity for any reason, uncorrected structural heart disease)\r\n\r\n          -  If girl and/or mother is unable to read, understand, or complete the informed consent\r\n             or surveys in English.\r\n\r\n          -  Musculoskeletal injuries or disorders that would prevent participation\r\n\r\n          -  Taking diabetes (type 1 or 2), renal diseases, eating disorder, pregnancy medication\r\n\r\n          -  Take medications affecting growth (e.g., insulin, oral hypoglycemic, thyroid hormone)\r\n      ","sponsor":"University of Massachusetts, Amherst","sponsor_type":"Other","conditions":"Physical Activity","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Girls and mothers Afro-centric dance program","description":"African-American girls and their mom's will participate in an after school Afro-centric dance program for 3 days/week for 12 weeks. Both girls and the mothers will also receive weekly newsletter containing various health information."},{"intervention_type":"Behavioral","name":"Behavioral: Girls, alone","description":"African-American girls (without their mom's) will participate in an after school Afro-centric dance program for 3 days/week for 12 weeks. Both girls and the mothers will also receive weekly newsletter containing various health information."},{"intervention_type":"Other","name":"Other: Newsletter","description":"Both girls and the mothers will receive weekly newsletter containing various health information."}],"outcomes":[{"outcome_type":"primary","measure":"Change from baseline in physical activity level at 12-weeks","time_frame":"Baseline, 6-weeks and 12-weeks after study initiation"},{"outcome_type":"secondary","measure":"Changes in body mass index, fasting insulin, and psychosocial","time_frame":"Baseline and 12-weeks after the initiation of the study protocol"}]}
{"nct_id":"NCT02373501","start_date":"2013-01-31","phase":"N/A","enrollment":95,"brief_title":"Extra - Abdominal Versus Intra - Abdominal Repair of the Uterine Incision at Cesarean Section","official_title":"Extra - Abdominal Versus Intra - Abdominal Repair of the Uterine Incision at Cesarean Section","primary_completion_date":"2018-12-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-12-01","last_update":"2018-12-04","description":"To evaluate the effects of extra-abdominal repair of the uterine incision compared to intra-abdominal repair, and to study is there superiority of one technique over the other in terms of primary outcomes - operative( up to 4 hours after beginning of anesthesia) and post operative ( until day 4 after operation ) measurements , secondary outcomes, long-term outcomes and subjective outcomes. PRIMARY OUTCOMES: Intra - operative ( during the operation up to 4 hours from anesthesia ) - nausea and vomiting - intraoperative hypotension - intraoperative pain Post operative ( 4 hours from anesthesia and until release from hospital ) - Blood transfusion - Venous thromboembolism - Febrile Morbidity - Endometritis - Wound Infection - Death Subjective measures: - complain of pain 1-10 on day 1 post operative - time until walking - number of Days until having bowel movement - overall satisfactory SECONDARY OUTCOMES: - Operative time - Estimated blood loss ( ebl ) - hemoglobin levels - Hospital stay","other_id":"SHEBA-13-0494-EC-CTIL","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":42,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  singleton pregnancy\r\n\r\n          -  term pregnancy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  chorioamnionitis\r\n\r\n          -  uterine rupture\r\n\r\n          -  hysterotomy - adhesiolysis\r\n      ","sponsor":"Sheba Medical Center","sponsor_type":"Other","conditions":"Cesarean Wound Repair","interventions":[{"intervention_type":"Procedure","name":"Procedure: Intra-abdominal repair","description":"Intra abdominal repair of uterine incision"},{"intervention_type":"Procedure","name":"Procedure: Extra-abdominal repair","description":"Extra abdominal repair of uterine incision"}],"outcomes":[{"outcome_type":"primary","measure":"nausea and vomiting","time_frame":"during operation- 4 hours from anasthesia"},{"outcome_type":"primary","measure":"intraoperative hypotension","time_frame":"during operation- 4 hours from anasthesia"},{"outcome_type":"primary","measure":"intraoperative pain","time_frame":"during operation- 4 hours from anasthesia"},{"outcome_type":"primary","measure":"Blood transfusion","time_frame":"during operation- 4 hours from anasthesia"},{"outcome_type":"primary","measure":"Venous thromboembolism","time_frame":"durind operation - 4 hours from anasthesia"},{"outcome_type":"primary","measure":"Febrile Morbidity","time_frame":"post operative - untill release from hospitalization usually day 4"},{"outcome_type":"primary","measure":"Endometritis","time_frame":"post operative- untill release from hospitalization usually day 4"},{"outcome_type":"primary","measure":"Wound Infection","time_frame":"post operative- untill release from hospitalization usually day 4"},{"outcome_type":"primary","measure":"Death","time_frame":"post operative - untill release from hospitalization usually day 4"},{"outcome_type":"secondary","measure":"Operative time","time_frame":"operative time - since anasthesia untill closure of skin"},{"outcome_type":"secondary","measure":"Estimated blood loss ( ebl ) - HGB levels","time_frame":"operative- 4 hours from anasthesia"},{"outcome_type":"secondary","measure":"Hospital stay","time_frame":"post operative"},{"outcome_type":"other","measure":"complain of pain 1-10 on day 1 post operative","time_frame":"post operative - on day 3 post operative"},{"outcome_type":"other","measure":"time from surgery until first walking","time_frame":"post operative - during hospitalization"},{"outcome_type":"other","measure":"number of Days until having bowel movement,","time_frame":"post operative - during hospitalization"},{"outcome_type":"other","measure":"overall satisfactory","time_frame":"post operative - during hospitalization"}]}
{"nct_id":"NCT01773499","start_date":"2013-01-31","enrollment":3,"brief_title":"Sonographic Features of Cellulitis and Failure of Therapy","official_title":"Sonographic Features of Cellulitis and Failure of Therapy","primary_completion_date":"2014-07-31","study_type":"Observational","rec_status":"Terminated","completion_date":"2014-10-31","last_update":"2015-03-20","description":"Skin and soft tissue infections represent a tremendous burden to the health care community with over 11.6 million ambulatory patients presenting annually in 2003 and 14.2 million in 2005. A Cochrane review of cellulitis found that there is limited data to support any specific antibiotic or even a specific length of antibiotic therapy, and that outpatient therapy for cellulitis is increasing. Soft tissue ultrasound has been shown to have utility in differentiating cellulitis from abscess but its role in patients with cellulitis is not well developed. Although speculative, the investigators hypothesize that sonographic features of cellulitis are associated with clinical improvement and successful therapy following antibiotics for patients with cellulitis.","other_id":"UMASSEDUS3","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients with Cellulitis","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18 years or older Symptoms of cellulitis (localized warmth, erythema, swelling or\r\n             tenderness)\r\n\r\n        Exclusion Criteria:\r\n\r\n        Admitted for inpatient antibiotics Unable to consent Septic appearing crepitus on exam\r\n        animal bite soft tissue abscess osteomylitis cellulitis requiring surgical debridement\r\n      ","sponsor":"University of Massachusetts, Worcester","sponsor_type":"Other","conditions":"Cellulitis","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Failure of therapy","time_frame":"7 days","description":"Patients with change in antibiotics or hospital admission"}]}
{"nct_id":"NCT01770743","start_date":"2013-01-31","phase":"Phase 2","enrollment":168,"brief_title":"A Phase 2 Safety and Immunogenicity Study for an Anthrax Vaccine Using 3 Schedules and Two Dose Levels","official_title":"A Phase 2, Randomized, Parallel-Group, Active-Controlled, Double-Blind Study to Evaluate the Safety and Immunogenicity of AV7909 for Post-Exposure Prophylaxis of Anthrax Using Three Immunization Schedules and Two Dose Levels in Healthy Adult Volunteers","primary_completion_date":"2014-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-12-31","last_update":"2015-02-24","description":"The purpose of this study is to assess the safety and immunogenicity of an anthrax vaccine. The vaccine schedule and dose will also be assessed.","other_id":"EBS.AVA.208 / DMID 11-0055","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Be 18-50 years old\r\n\r\n          -  Be in good health\r\n\r\n          -  Have access to a computer and the internet so you can complete a diary\r\n\r\n          -  Agree to abstain from sex the first 84 days of the study or practice birth control if\r\n             you are a woman who is able to get pregnant\r\n\r\n          -  Have not donated blood for the previous 8 weeks\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  A known anaphylactic response, severe systemic response, or serious hypersensitivity\r\n             reaction to a prior immunization.\r\n\r\n          -  A history of latex allergy.\r\n\r\n          -  Have received a shot (vaccine), including flu shots, in the past 6 weeks or plan to\r\n             get a shot for 4 weeks after the last study shot is given.\r\n\r\n          -  Have previously served in the military any time after 1990 or plan to enlist in the\r\n             military from Screening through Day 84.\r\n\r\n          -  Prior immunization with anthrax vaccine, recombinant protective antigen (rPA) vaccine,\r\n             or known exposure to anthrax organisms.\r\n\r\n          -  Have participated in anthrax therapeutic or vaccine studies (monoclonal anti-PA or\r\n             anthrax immune globulins or anthrax vaccines).\r\n\r\n          -  Participation in any investigational study involving use of a pharmacological\r\n             intervention within 30 days before the Screening visit or planning to participate in a\r\n             study requiring dosing through the 12-month safety follow-up telephone call.\r\n\r\n          -  Have a known diagnosis of any immunodeficiency disease including but not limited to:\r\n             acquired immune deficiency syndrome (AIDS), common variable immunodeficiency disease,\r\n             immunoglobulin A (IgA) deficiency, or hypogammaglobulinemia.\r\n\r\n          -  Past history of significant autoimmune disease such as rheumatoid arthritis, lupus\r\n             erythematous, psoriasis in the area of vaccinations, or requires immunotherapy,\r\n             glomerulonephritis, or autoimmune thyroiditis.\r\n\r\n          -  Have received immunosuppressive therapy with cytotoxic drugs or Rituximab within the\r\n             past 2 years.\r\n\r\n          -  A history of cytotoxic chemotherapy or radiation therapy.\r\n\r\n          -  Chronic (>10 days) daily oral or parenteral corticosteroid therapy in the past 12\r\n             months.\r\n\r\n          -  Any lung disease, including reactive airway disease, which requires the daily use of\r\n             medications.\r\n\r\n          -  A female currently breastfeeding or with a positive pregnancy test.\r\n\r\n          -  A history of drug or alcohol abuse within 12 months prior to Screening, or a positive\r\n             result on a urine drug screen for cocaine, marijuana, opiates, methamphetamines,\r\n             benzodiazepines, or oxycodone.\r\n\r\n          -  Any tattoo or other skin condition in the deltoid region on either arm that may\r\n             obscure the assessment of the injection sites.\r\n\r\n          -  A medical condition that, in the opinion of the PI or designee, could adversely impact\r\n             the subject's participation or safety or the conduct of the study.\r\n\r\n          -  Any planned elective in-patient surgery during the study period.\r\n      ","sponsor":"Emergent BioSolutions","sponsor_type":"Industry","conditions":"Anthrax","interventions":[{"intervention_type":"Biological","name":"Biological: AV7909","description":"Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"},{"intervention_type":"Biological","name":"Biological: BioThrax"}],"outcomes":[{"outcome_type":"primary","measure":"Toxin Neutralizing Antibody (TNA) Level at Day 63","time_frame":"Day 63","description":"Immunogenicity measured by the lower bound (LB) of the 95% confidence intervals (CIs) for the proportion of subjects in each study arm with Day 63 TNA 50% neutralization factor (NF50) values greater than or equal to threshold"},{"outcome_type":"primary","measure":"Incidence of Adverse Events","time_frame":"From the time of the first immunization on Day 0 through Day 84","description":"Incidence of adverse events (including assessment of symptoms, physical exam findings, clinical laboratory tests, and vital signs) from the time of the first immunization on Day 0 through Day 84"},{"outcome_type":"primary","measure":"Incidence of Serious Adverse Events","time_frame":"From the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination","description":"Incidence of serious adverse events, from the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination"},{"outcome_type":"primary","measure":"Incidence of Reactogenicity By Severity","time_frame":"For 7 days following each vaccination on Days 0, 14, 28","description":"Incidence of solicited systemic reactions and solicited injection site reactions each day for 7 days following each vaccination using subject e-diaries by severity.\r\nReactions were graded using the following scale (note, for redness and swelling, the diameter [greater of two perpendicular measurements] was assessed by the subject using an injection site measurement tool):\r\nGrade 0 (Absent): Symptom not present; Grade 1 (Mild): Symptom present but does not interfere with activities of daily living, or affected area (redness, swelling) measures <3 cm; Grade 2 (Moderate): Symptom causes some interference with activities of daily living, or affected area (redness, swelling) measures 3 - 10 cm; Grade 3 (Severe): Symptom prevents activities of daily living or requires treatment, or affected area (redness, swelling) measures > 10 cm.\r\nFor each reaction, subjects are counted once across all vaccinations at the highest reported level of severity."},{"outcome_type":"primary","measure":"Incidence of Clinical Laborabory Abnormalities","time_frame":"From the time of first immunization on Day 0 to Day 84","description":"Incidence of clinical laboratory abnormalities throughout the study (up to Day 84).\r\nClinical laboratory abnormalities are presented as the total of Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), and Grade 4 (potentially life-threatening) abnormalities according to criteria adapted from the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research: Guidance for Industry. Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007). Within each laboratory parameter, subjects are counted once for their most severe occurrence of clinical laboratory abnormality."},{"outcome_type":"primary","measure":"Incidence of Immunologically Significant Adverse Events of Special Interest","time_frame":"From the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination","description":"Incidence of immunologically significant adverse events of special interest as defined by the Center for Biologics Evaluation and Research from the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination"},{"outcome_type":"secondary","measure":"TNA Level at Day 42","time_frame":"Day 42","description":"Immunogenicity measured by the percentage of subjects in each study arm with Day 42 TNA NF50 values greater than or equal to threshold"},{"outcome_type":"secondary","measure":"TNA Level at Day 28","time_frame":"Day 28","description":"Immunogenicity measured by the percentage of subjects with Day 28 TNA NF50 values greater than or equal to threshold"},{"outcome_type":"secondary","measure":"TNA Seroconversion Rate","time_frame":"Up to Day 84","description":"Immunogenicity measured by the percentage of subjects who have seroconverted (defined as a 4-fold increase over Day 0 in TNA NF50 value) at Days 21, 28, 35, 42, 49, 63, and 84"}]}
{"nct_id":"NCT02004743","start_date":"2013-01-31","phase":"N/A","enrollment":99,"brief_title":"Early Prevention of Post Traumatic Stress Disorder","official_title":"Program Development in Guideline Development, Early Recognition and Specialized Treatment of Post Traumatic Stress Disorder (PTSD) at Sunnybrook Health Sciences Center, Canada's Largest Trauma Center","primary_completion_date":"2014-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-09-30","last_update":"2016-08-10","description":"Sunnybrook Health Sciences Centre is Canada's largest trauma centre, treating 1,100 patients annually. A traumatic experience can lead to post-traumatic stress disorder, which increases hospital stays, emergency visits and disability. Despite developing leadership to manage a \"Code Orange\" mass trauma, Sunnybrook lacks guidelines in the psychological management of patients who have experienced trauma. The department of psychiatry currently holds a Traumatic Brain Injury clinic and PTSD services for youth but lacks both immediate intervention, prevention and adult services. This research will enable us to gain best evidence expertise to develop guidelines as well as a sustainable PTSD treatment program, with clear outcomes to assess effectiveness, psychiatric morbidity, use of healthcare, disability and substance abuse. The five world-expert-consensus intervention resilience based principles will be operationalized in guidelines for the management of trauma patients, their caregivers and in routine nursing and trauma team care from the Emergency to the ward, and discharge, through to outpatient care. It is hypothesized that this will improve the psychological recovery of patients at risk of developing PTSD after a traumatic injury. In addition, early screening and intervention for increased risk of PTSD will be implemented one month after the trauma. It is hypothesized that such trauma informed psychological management, early screening and expert treatment using prolonged exposure will reduce hospital stays, functional disability, as well as longer-term psychiatric morbidity, including substance abuse.","other_id":"258-2012","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":14,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  undergone severe physical trauma within the last 3 days\r\n\r\n          -  An abbreviated Injury Severity score of 1-3\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  14 years of age or younger\r\n\r\n          -  an inability to communicate sufficiently in English\r\n\r\n          -  A diagnosis of psychosis, mental retardation and/or autism\r\n      ","sponsor":"Sunnybrook Health Sciences Centre","sponsor_type":"Other","conditions":"Post Traumatic Stress Disorder","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Intervention","description":"Psychological guidelines and PET\r\nPatients will receive questionnaires at recruitment, 1 month, 3 months and 6 months based on the timeline of Diagnostic and Statistical Manual (DSM) -IV criteria for PTSD."},{"intervention_type":"Other","name":"Other: Treatment as usual","description":"Participants will experience treatment as usual.\r\nPatients will receive questionnaires at recruitment, 1 month, 3 months and 6 months based on the timeline of Diagnostic and Statistical Manual (DSM) -IV criteria for PTSD"}],"outcomes":[{"outcome_type":"primary","measure":"Presence & severity of PTSD symptoms","time_frame":"1 month, 3 months & 6 months","description":"The aim of the study is to observe whether there's a presence and severity (if applicable) of Posttraumatic symptoms in patients who've received the intervention, compared to those who have not.\r\nPresence and severity of PTSD symptoms will be measured by:\r\nfollow-up at 1 month, 3 months & 6 months which involve specific PTSD self-report symptom measures: PTSD Symptom Scale\r\nStructured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorder (SCID) Semi-structured interview performed at 6 months either over the phone or in person"},{"outcome_type":"primary","measure":"Depressive symptoms","time_frame":"recruitment, 1 month, 3 months & 6 months","description":"The Beck Depression Inventory - Second Edition (BDI-II) will be used at recruitment, 1 month, 3 months, and 6 months follow-up to measure the presence and/or change in depressive symptoms of the patient."},{"outcome_type":"secondary","measure":"Anxiety & dissociation symptoms","time_frame":"recruitment & 1 month","description":"Patients will be assessed for anxiety and dissociation symptoms at recruitment and follow-up at 1 month with the Stanford Acute Stress Reaction Questionnaire (SASRQ)."},{"outcome_type":"secondary","measure":"Change in patient health & well-being","time_frame":"6 months","description":"The Short Form (36) Health Survey (SF-36v2) will be used at 6 months follow-up to assess a patient's health and/or disability."},{"outcome_type":"secondary","measure":"Change in substance use","time_frame":"recruitment, 1 month, 3 months & 6 months","description":"PTSD is highly correlated with substance use. By implementing a preventative intervention, one aim is to reduce overall substance use. This will be assessed using the Alcohol Use Disorders Identification Test (AUDIT) and the Drug Abuse Screening Test (DAST) at recruitment, 1 month, 3 months and 6 months."},{"outcome_type":"secondary","measure":"Presence & severity of trauma related thoughts and beliefs","time_frame":"1 month, 3 months & 6 months","description":"follow-up at 1 month, 3 months & 6 months which involve specific PTSD self-report symptom measures: The Posttraumatic Cogntions Inventory (PTCI)"},{"outcome_type":"secondary","measure":"Self-esteem","time_frame":"recruitment, 1 month, 3 months & 6 months","description":"The Rosenberg Self-Esteem Scale (RSES) will be used at recruitment, 1 month, 3 months, and 6 months follow-up to measure any change in the patient's self-esteem over time."},{"outcome_type":"secondary","measure":"Locus of Control","time_frame":"recruitment, 1 month, 3 months & 6 months","description":"The Internal Control Index (ICI) will be used at recruitment, 1 month, 3 months, and 6 months follow-up to measure any changes with a patient's Locus of Control, the extent to which they feel they can control the events that occur to them."},{"outcome_type":"secondary","measure":"Self-efficacy","time_frame":"recruitment, 1 month, 3 months & 6 months","description":"The Self-Efficacy Scale will be used at recruitment, 1 month, 3 months & 6 months follow-up to asses any changes in a patient's self-efficacy/personal competence."}]}
{"nct_id":"NCT01816867","start_date":"2013-01-31","enrollment":96,"brief_title":"Laparoscopic and Open Ventral Hernia Repair Using the Intramesh T1","official_title":"Laparoscopic and Open Ventral Hernia Repair Using the Intramesh T1: a Prospective, Multicenter Registry","primary_completion_date":"2014-10-31","study_type":"Observational [Patient Registry]","rec_status":"Completed","completion_date":"2014-10-31","last_update":"2015-05-22","description":"The purpose of the registry is to evaluate safety and efficacy of the Intramesh T1. This registry will collect data from 100 patients treated for a ventral hernia repair.","other_id":"BM-T1-08","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients with a ventral hernia","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patient is older than 18 years\r\n\r\n          -  Written informed consent is obtained from patient\r\n\r\n          -  Patient with a primary or incisional ventral hernia\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patient with a recurrent ventral hernia\r\n\r\n          -  Patient with ASA class 5 and 6\r\n\r\n          -  Patient underwent emergency surgery\r\n\r\n          -  Patient is pregnant\r\n\r\n          -  Patient with a known allergy to components of the ePTFE prosthesis\r\n\r\n          -  Patient has a life expectancy less than 1 year\r\n\r\n          -  Patient is unable to be compliant with the follow-up visits due to geographical,\r\n             social or psychological factors\r\n      ","sponsor":"be Medical","sponsor_type":"Industry","conditions":"Ventral Hernia","interventions":[{"intervention_type":"Device","name":"Device: Intramesh T1 implantation"}],"outcomes":[{"outcome_type":"primary","measure":"Recurrence rate at 12 months determined by clinical examination","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Intraoperative complications","time_frame":"peri-procedural","description":"Defined as complications occurring during index-procedure from \"skin-into-skin\". The following events must be reported in the case report form:\r\nenterotomy (bowel injury)\r\nmajor bleeding requiring blood transfusion or reintervention\r\ncomplications due to anesthesia\r\nminor bleeding at a trocar insertion site"},{"outcome_type":"secondary","measure":"Post-operative complications","time_frame":"up to 30 days","description":"Defined as complications up to 30 days after index-procedure. The following events should be reported in the case report form:\r\nlocal numbness\r\nhematoma\r\nseroma\r\nsuperficial trocar site infection\r\nmesh infection\r\nhernia recurrence\r\ndeath"},{"outcome_type":"secondary","measure":"Seroma","time_frame":"1 month","description":"The rate of seroma at 1 month after index-procedure."},{"outcome_type":"secondary","measure":"Freedom from hernia-related reinterventions","time_frame":"12 months","description":"Reinterventions at 12 months after index-procedure"},{"outcome_type":"secondary","measure":"Late complications","time_frame":"12 months","description":"Late complications at 12 months after index-procedure:\r\nprolonged pain more than 8 weeks\r\nlocal numbness\r\nhernia recurrence"}]}
{"nct_id":"NCT02367430","start_date":"2013-01-31","phase":"N/A","enrollment":14,"brief_title":"Critical Time Intervention for Individuals With Hoarding Disorder","official_title":"Critical Time Intervention for Individuals With Hoarding Disorder","primary_completion_date":"2015-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-07-31","last_update":"2020-02-11","description":"The purpose of this study is to investigate whether a well-established case management model called Critical Time Intervention (CTI) can help individuals with hoarding disorder who are concerned about the risk of eviction. Each individual with hoarding disorder will be assigned to work with a CTI Specialist for 9 months, who will provide referrals for mental health treatment, legal consultations, and registration for entitlements. All participants will be offered a facilitated group intervention called the Buried in Treasures Workshop. The CTI Specialist will also facilitate reconnecting the individual with supportive family/friends and will monitor and support the de-cluttering of the patient's home.","other_id":"6681","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  primary Hoarding Disorder\r\n\r\n          -  age 18 or over\r\n\r\n          -  Individuals concerned with the threat of eviction due to clutter\r\n\r\n          -  Patient must be physically healthy\r\n\r\n          -  Willing and able to understand and complete consent procedure\r\n\r\n          -  English speaking\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Not primary Hoarding Disorder\r\n\r\n          -  Severly depressed patients; Hamilton depression rating scale greater than 30 or judged\r\n             clinically to be at risk of suicide with Columbia Suicide Severity Rating Scale\r\n      ","sponsor":"New York State Psychiatric Institute","sponsor_type":"Other","conditions":"Hoarding Disorder","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Critical Time Intervention With Buried in Treasures included","description":"Critical Time Intervention and BIT Workshop"}],"outcomes":[{"outcome_type":"primary","measure":"Savings Inventory-Revised","time_frame":"Baseline, 3 months, 6 months and 9 months","description":"The Saving Inventory-Revised scale (SI-R) is a 23-item questionnaire with 3 factor-analytically defined sub-scales for difficulty discarding, excessive clutter, and compulsive acquisition.\r\nThe total score (sum of 23 items) ranges from 0 to 92. Total score higher than 41 shows significant difficulty with clutter.\r\nFor the acquisition subscale we sum items 2 (reverse score), 9, 11, 14, 16, 18 and 21. The subscale ranges from 0 to 28 and score greater than 13 indicates difficulty with excessive acquisition.\r\nFor the difficulty discarding subscale we sum items 4(reverse score), 6, 7, 13, 17, 19, 23. The subscale ranges from 0 to 28 and score greater than 13 indicates difficulty with discarding.\r\nFor the clutter subscale we sum items 1, 3, 5, 8, 10, 12, 15, 20, 22. The subscale ranges from 0 to 36 and score greater than 15 indicates difficulty with accumulated clutter."},{"outcome_type":"primary","measure":"Clutter Image Rating Scale","time_frame":"Baseline, 3 months, 6 months and 9 months","description":"Clutter Image Rating ScaleL Three sets of photographs, each containing nine photos of a single room with varying levels of clutter. A selection is made as to which photograph best resembles their own home.\r\nThis scale assesses the clutter levels in the bedroom, living room and kitchen. The scale for each room ranges from 1 to 9. Clutter that reaches the level 4 indicates significant difficulty with clutter that affects the person's life."}]}
{"nct_id":"NCT01675076","start_date":"2013-01-31","phase":"Phase 3","enrollment":663,"brief_title":"Strategy of Continued Versus Interrupted Novel Oral Anti-coagulant at Time of Device Surgery in Patients With Moderate to High Risk of Arterial Thromboembolic Events","official_title":"A Randomized Controlled Trial to Investigate Whether a Strategy of Continued Versus Interrupted Novel Oral Anti-coagulant at the Time of Device Surgery, in Patients With Moderate to High Risk of Arterial Thrombo-embolic Events, Leads to a Reduction in the Incidence of Clinically Significant Hematoma","primary_completion_date":"2017-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-05-31","last_update":"2019-10-07","description":"The purpose of this study is to determine the best strategy to manage novel oral anti-coagulants (NOACs) at the time of pacemaker or defibrillator surgery. The Investigators hypothesize that performing device surgery without interruption of the novel oral anti-coagulant will result in a reduced rate of clinically significant hematoma.","other_id":"UOHI-05","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  any patient undergoing device surgery (ie. de novo device implant or pulse generator\r\n             change or lead replacement or pocket revision)\r\n\r\n          -  receiving Dabigatran or Rivaroxaban or Apixaban for at least 5 days prior to\r\n             enrollment\r\n\r\n          -  non-rheumatic atrial fibrillation and/or atrial flutter at moderate or high risk of\r\n             ATE defined as: i) CHA2DS2VASc score greater than or equal to 2 OR ii) CHA2DS2VASc\r\n             score < 2 with plan for cardioversion or defibrillation threshold testing at time of\r\n             device surgery\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  unable or unwilling to provide informed consent\r\n\r\n          -  history of noncompliance of medical therapy\r\n\r\n          -  active device infection\r\n\r\n          -  eGFR < 30 mL/min\r\n\r\n          -  contraindication to NOAC\r\n\r\n          -  rheumatic valvular disease with hemodynamically significant valve lesion\r\n\r\n          -  mechanical heart valve\r\n      ","sponsor":"Ottawa Heart Institute Research Corporation","sponsor_type":"Other","conditions":"Hematoma","interventions":[{"intervention_type":"Drug","name":"Drug: Dabigatran","description":"NOAC"},{"intervention_type":"Drug","name":"Drug: Rivaroxaban","description":"NOAC"},{"intervention_type":"Drug","name":"Drug: Apixaban","description":"NOAC"}],"outcomes":[{"outcome_type":"primary","measure":"Clinically significant hematoma","time_frame":"2 weeks post-op or until resolution of hematoma","description":"Defined as:\r\nHematoma requiring re-operation\r\n- Defined as a hematoma that continues to expand despite all appropriate non-operative measures, or is producing impending or actual wound breakdown or skin necrosis. Minor hematomas that are evacuated at the time of other re-operation (eg. for lead repositioning) are not considered as a primary outcome.\r\nor\r\nHematoma resulting in prolongation of hospitalization\r\n- Defined as extended hospitalization or rehospitalization for > 24 hours, post index surgery, primarily due to hematoma.\r\nor\r\nHematoma requiring interruption of anti-coagulation. - Defined as reversal or intentional withholding of all anticoagulation for > or = 24 hours, in response to wound hematoma."},{"outcome_type":"secondary","measure":"Composite of major peri-operative bleeding events and thrombo-embolic events","time_frame":"2 weeks post-op","description":"Each of the components of the primary outcome\r\nComposite of all other major peri-operative bleeding events defined as:\r\nhemothorax\r\ncardiac tamponade\r\nsignificant pericardial effusion\r\nThrombo-embolic events defined as:\r\ntransient ischemic attack\r\nstroke\r\ndeep venous thrombosis\r\npulmonary embolism\r\nperipheral embolus to limb\r\nperipheral embolus to other major organ\r\nAll cause mortality\r\nCost utilization\r\nPatient quality of life and peri-operative pain, and satisfaction"}]}
{"nct_id":"NCT02135367","start_date":"2013-01-31","phase":"N/A","enrollment":185,"brief_title":"Platelet-rich Plasma (PRP) vs Viscosupplementation for the Treatment of Early Knee Articular Degenerative Pathology","official_title":"Platelet-rich Plasma (PRP) vs Viscosupplementation for the Treatment of Early Knee Articular Degenerative Pathology: a Randomized Double-blind Controlled Trial","primary_completion_date":"2018-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-04-30","last_update":"2018-08-08","description":"The investigators hypothesized that intra-articular injections of Platelet-rich Plasma (PRP) to treat knee degenerative articular cartilage pathology could determine pain relief and recovery of knee function with overall clinical outcome comparable or even better than viscosupplementation, which is a common injective approach applied in this kind of pathology. To this purpose the investigators designed a double blind randomized controlled trial comparing PRP vs viscosupplementation. A power analysis has been performed for the primary endpoint of IKDC subjective score improvement at the 12-month follow-up for PRP. From a pilot study, a standard deviation of 15.2 points was found. With an alpha error of 0.05, a beta error of 0.2 and a minimal clinically significant difference of 6.7 points corresponding at 1/3 of the documented mean improvement, the minimum sample size was 83 for each group. Considering a possible drop out of 15%, 96 patients per group are required for total 192 patients, selected according to well-defined inclusion criteria (see 'Eligibility criteria' section). Patients are then assigned to two different treatment groups, according to a randomization list. The first group of treatment consists of three weekly intra-articular injections of autologous PRP obtained with the following procedure: a 150-ml autologous venous blood sample undergoes 2 centrifugations (the first at 1480 rpm for 6 minutes to separate erythrocytes, and a second at 3400 rpm for 15 minutes to concentrate platelets) to produced 20 ml of PRP. This unit of PRP is then divided into 4 small units of 5 ml each. One unit is sent to the laboratory for analysis of platelet concentration and for a quality test, 3 units are stored at -30 C. The second treatment group consists of patients receiving three weekly injections of hyaluronic acid (Hyalubrix 30 mg/2ml, Fidia Farmaceutici Spa, Italy;Molecular Weight: 1500 kDa). To guarantee the blinding of the patients, all of them undergo blood harvesting to obtain autologous PRP which will be used only in half of them, according to the aforementioned randomization list. One week after the PRP production, the injective treatment starts, with 3 weekly injections of PRP or HA. At the moment of the injection the syringe is properly covered to prevent the patient from discovering the substance he was receiving. After the injection, patients are sent home with instructions to limit the use of the leg for at least 24 h and to use cold therapy/ice on the affected area to relieve pain. During this period, the use of non-steroidal medication is forbidden. Patients are prospectively evaluated basally and at 2, 6, and 12 months of follow-up using clinical subjective scores and objective parameters to determine clinical outcome (see 'Outcome measure' section). Patient satisfaction and adverse events will be also reported. All the clinical evaluations are performed by a medical staff not involved in the injective procedure, in order to keep the study double blinded. At the end of the study, the nature of the injected substance is revealed to the patients.","other_id":"PRP-KNEE 012","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  age ranging from 18 to 55\r\n\r\n          -  patients affected by knee articular degenerative pathology with history of chronic\r\n             (for at least 4 months) pain or swelling;\r\n\r\n          -  imaging findings of degenerative changes of the joint (Kellgren Lawrence 0 to 2 at\r\n             X-ray evaluation).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  age > 55 years;\r\n\r\n          -  Kellgren-Lawrence score at X-ray evaluation > 2;\r\n\r\n          -  major axial deviation (varus >5 , valgus > 5),\r\n\r\n          -  systemic disorders such as diabetes, rheumatoid arthritis, haematological diseases\r\n             (coagulopathy), severe cardiovascular diseases, infections, immunodepression;\r\n\r\n          -  patients in therapy with anticoagulants or antiaggregants;\r\n\r\n          -  use of NSAIDs in the 5 days before blood donation;\r\n\r\n          -  previous intra-articular injections in the past 6 months before blood donation;\r\n\r\n          -  previous knee surgery in the past 12 months before blood donation;\r\n\r\n          -  patients with Hb values < 11 g/dl and platelet values < 150,000/mmc\r\n      ","sponsor":"Istituto Ortopedico Rizzoli","sponsor_type":"Other","conditions":"Knee Chondropathy|Knee Early Osteoarthritis","interventions":[{"intervention_type":"Biological","name":"Biological: PRP","description":"injections of Platelet rich Plasma"}],"outcomes":[{"outcome_type":"primary","measure":"IKDC (International Knee Documentation Committee) subjective score","time_frame":"12 months evaluation","description":"The primary outcome is the difference in IKDC-subjective score at 12 months' follow-up between treatment groups (visco-supplementation vs PRP)"},{"outcome_type":"secondary","measure":"VAS (Visual Analogue Scale) for General Health status","time_frame":"2-, 6-, 12- months evaluation","description":"Any inter-group difference in general health status, evaluated by a VAS, will be documented at 2-, 6- and 12-months' follow-up"},{"outcome_type":"secondary","measure":"KOOS (Knee injury and Osteoarthritis Outcome Score) score","time_frame":"2-, 6-, 12- months evaluation","description":"Any inter-group difference in KOOS Score will be documented at 2-, 6- and 12-months' follow-up"},{"outcome_type":"secondary","measure":"IKDC objective score","time_frame":"2-, 6-, 12- months evaluation","description":"Any inter-group difference in IKDC objective score will be documented at 2-, 6- and 12-months' follow-up"},{"outcome_type":"secondary","measure":"Tegner Score","time_frame":"2-, 6-, 12- months evaluation","description":"Any inter-group difference in Tegner Score, will be documented at 2-, 6- and 12-months' follow-up"},{"outcome_type":"secondary","measure":"Adverse events","time_frame":"2-, 6-, 12- months evaluation","description":"Any eventual adverse events will be documented at any follow-up evaluations of the present study"},{"outcome_type":"secondary","measure":"Patients' satisfaction","time_frame":"12 months","description":"Patients' satisfaction for the treatment received will be registered at the final 12 months evaluation"}]}
{"nct_id":"NCT02033837","start_date":"2013-01-31","enrollment":309,"brief_title":"Evaluation of Cardiac CT Appropriateness at Second-generation 320-row CT","official_title":"Evaluation of Cardiac CT Appropriateness at Second-generation 320-row CT With 0.275-sec Gantry Rotation Speed","primary_completion_date":"2017-08-31","study_type":"Observational","rec_status":"Completed","completion_date":"2017-08-31","last_update":"2017-08-22","description":"The influence of the second-generation 320-row area-detector CT (ADCT) on the clinical indications and appropriateness of cardiac CT has not been adequately investigated. The purpose of the survey is to assess the distribution of appropriateness ratings and test outcomes of cardiac CT with second-generation ADCT.","other_id":"Kuma1594","observational_model":"Case-Only","time_perspective":"Cross-Sectional","sampling_method":"Probability Sample","gender":"All","minimum_age":20,"maximum_age":90,"population":"Consecutive patients referred for coronary CT angiography at our hospital","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  indicated for coronary CT assessment\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  aortic disease\r\n\r\n          -  pulmonary embolism\r\n\r\n          -  severe arrhythmia\r\n\r\n          -  severe heart failure\r\n\r\n          -  allergy for iodinated contrast agent\r\n      ","sponsor":"Kumamoto University","sponsor_type":"Other","conditions":"Coronary Artery Disease|Cardiac CT","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"significant coronary stenosis","time_frame":"one year"}]}
{"nct_id":"NCT01646801","start_date":"2013-01-31","phase":"N/A","enrollment":20,"brief_title":"Study of NMB Drug Ejecting Balloon for Peripheral Arteries","official_title":"The Use of NMB Drug Ejecting Balloon for Treatment of Patients With Peripheral Arterial Disease","primary_completion_date":"2014-01-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2015-01-31","last_update":"2012-07-24","description":"The purpose of this study is to demonstrate the Safety and effectiveness of the use of NMB's drug ejecting balloon for the treatment of de novo and restenotic lesions in peripheral arterial disease.","other_id":"NMB PP CLD 2158","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients 18 years old or older\r\n\r\n          -  Patient with lifestyle limiting claudication or rest pain (Rutherford- Becker scale 2,\r\n             3 or 4).\r\n\r\n          -  Patient with de novo lesion or restenotic lesion 70% in the iliac, femoral, popliteal\r\n             or tibial artery.\r\n\r\n          -  The target lesion can be successfully crossed with a guide wire and dilated.\r\n\r\n          -  The target lesion is in a native artery of 2.5-10mm in diameter and less than 80 mm in\r\n             length.\r\n\r\n          -  Patient is willing to and able to sign a written informed consent and to comply with\r\n             procedures (e.g., adherence to follow-up visits, including 6 months CT-angiography/MRA\r\n             follow-up).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Women who are pregnant or breast-feeding and women of childbearing potential who do\r\n             not use adequate contraception.\r\n\r\n          -  Previous participation in another study with any investigational drug or device within\r\n             the past 30 days.\r\n\r\n          -  The patient is currently enrolled in another investigational device or drug trial.\r\n\r\n          -  Severe reaction to contrast agents that cannot be adequately premedicated prior to\r\n             procedure.\r\n\r\n          -  Stenosis with corresponding thrombosis treated within 7 days before enrollment.\r\n\r\n          -  Patient with known contraindications for aspirin or other anticoagulant/antiplatelet\r\n             therapy.\r\n\r\n          -  Patient that has co-morbid illness that may result in life expectancy of less than 12\r\n             months.\r\n\r\n          -  History of haemorrhagic stroke or gastro-intestinal bleeding within 6 months.\r\n\r\n          -  Patient with major surgery during the 30 days preceding the interventional procedure.\r\n      ","sponsor":"N.M.B. Medical Applications Ltd","sponsor_type":"Industry","conditions":"Peripheral Arterial Disease","interventions":[{"intervention_type":"Device","name":"Device: NMB Balloon Catheter","description":"patients treated by the NMB's Drug Ejecting Balloon"}],"outcomes":[{"outcome_type":"primary","measure":"Late Lumen Loss (LLL)","time_frame":"6 months","description":"Late Lumen Loss (LLL) defined as the difference between the minimal luminal diameter after the procedure and at 6 months, as evaluated by Quantitative Angiography (mm units will be used)"},{"outcome_type":"secondary","measure":"Restenosis rate","time_frame":"6 months","description":"Restenosis is defined as stenosis of at least 50% of the luminal diameter at 6 months"},{"outcome_type":"secondary","measure":"Device Malfunction","time_frame":"intraprocedural, 3, 6 and 12 months"},{"outcome_type":"secondary","measure":"Adverse events","time_frame":"intraprocedural, 3, 6 and 12 months"}]}
{"nct_id":"NCT01778569","start_date":"2013-01-22","enrollment":1200,"brief_title":"The Psoriasis, Atherosclerosis, and Cardiometabolic Disease Initiative (PACI)","official_title":"Human Translational Studies of Inflammation and Cardiometabolic Diseases: The Psoriasis, Atherosclerosis and Cardiometabolic Disease (PACI) Initiative","primary_completion_date":"2030-06-30","study_type":"Observational","rec_status":"Recruiting","completion_date":"2030-06-30","last_update":"2021-09-01","description":"Background: - Cardiometabolic diseases are medical disorders that can occur together and affect the heart. They increase the risk of developing heart disease and diabetes. One disorder, psoriasis, is an inflammation that mostly affects the skin but can affect the entire body. Another disorder, atherosclerosis, is a process in which cholesterol is gradually deposited on the wall of arteries. This causes arteries to harden and become less flexible. Many cells that cause psoriasis also cause atherosclerosis. Researchers want to look at the relationship between cardiometabolic diseases and psoriasis. Objectives: - To study the relationship between psoriasis and cardiometabolic diseases. Eligibility: - Individuals at least 18 years of age who have psoriasis. Design: - Participants will be screened with a physical exam and medical history. - Participants will have up to seven outpatient visits over the 4 years. The first visit will be a screening visit. Visits 2 will be12 months after visit 1. Visits 3, 4, and 5, will be scheduled yearly for the next 3 years. If participants have a psoriasis flare with more severe symptoms, they may have an extra visit. Those who leave the study early will have a final visit with the full series of tests. - At visits 1, 2,and 5, and any flare visits, participants will have a physical exam and medical history. They will provide blood and urine samples, as well as optional tissue biopsies. They will also have heart function tests. Imaging studies, as well as optional photographs of affected areas, will be performed. These tests will also be performed at the final visit. - At visits 3 and 4, participants will have a physical exam and medical history. They will also provide blood and urine samples, and have heart function tests.","other_id":"130065","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":110,"population":"Any patient with a diagnosis of chronic plaque psoriasis, psoriatic arthritis, or pustular\r\n        psoriasis will be considered for this protocol.","criteria":"\n        -  INCLUSION CRITERIA\r\n\r\n          -  18 years of age or older\r\n\r\n          -  Diagnosed with psoriasis clinically confirmed by provider, consisting of typical skin\r\n             findings and associated findings of systemic disease of joints, nails and hair)\r\n\r\n        EXCLUSION CRITERIA\r\n\r\n          -  For skin and adipose biopsy, any subject with known bleeding disorder, current fever\r\n             or on anticoagulation.\r\n\r\n          -  For imaging studies, pregnant women and lactating women, unless they are willing to\r\n             discard breast milk for 24 hours after receiving FDG or contrast\r\n\r\n          -  Subjects with a contraindication to MRI scanning will not receive the optional\r\n             PET/MRI. These contraindications include subjects with the following devices:\r\n\r\n               -  Central nervous system aneurysm clips\r\n\r\n               -  Implanted neural stimulator\r\n\r\n               -  Implanted cardiac pacemaker or defibrillator\r\n\r\n               -  Cochlear implant\r\n\r\n               -  Ocular foreign body (e.g. metal shavings)\r\n\r\n               -  Implanted Insulin pump\r\n\r\n               -  Metal shrapnel or bullet\r\n\r\n          -  Subjects with a BMI >45 will also not receive the PET MRI.\r\n\r\n          -  Subjects with severe renal excretory dysfunction, estimated glomerular filtration rate\r\n             < 30 mL/min/1.73m^2 body surface area according to the Modification of Diet in Renal\r\n             Disease criteria, will not receive the cardiac CT angiography, or gadolinium contrast\r\n             agent during the PET/MRI.\r\n      ","sponsor":"National Heart, Lung, and Blood Institute (NHLBI)","sponsor_type":"NIH","conditions":"Metabolic Disease|Cardiovascular Disease|Inflammation|Psoriasis","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Our primary outcome of interest is vascular inflammation measured by standard uptake values from PET-CT imaging with FDG.","time_frame":"4-6 years","description":"vascular inflammation measured by standard uptake values from PET-CT imaging with FDG."},{"outcome_type":"secondary","measure":"Mean Aortic Wall Thickness","time_frame":"4-6 years"},{"outcome_type":"secondary","measure":"Coronary Artery Calcium Score","time_frame":"4-6 years"},{"outcome_type":"secondary","measure":"HDL function","time_frame":"4-6 years"},{"outcome_type":"secondary","measure":"lipoprotein particle size and number","time_frame":"4-6 years"},{"outcome_type":"secondary","measure":"immune, metabolic &amp; inflammation measure","time_frame":"4-6 years"},{"outcome_type":"secondary","measure":"Myocardial Flow Reserve (MFR)","time_frame":"4-6 years"}]}
{"nct_id":"NCT01714817","start_date":"2013-01-22","phase":"Phase 3","enrollment":695,"brief_title":"Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis","official_title":"A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BMS-188667 (Abatacept) or Placebo on a Background of Mycophenolate Mofetil and Corticosteroids in the Treatment of Subjects With Active Class III or IV Lupus Nephritis","primary_completion_date":"2016-11-21","study_type":"Interventional","rec_status":"Terminated","completion_date":"2018-05-30","last_update":"2021-02-26","description":"The purpose of this study is to evaluate (Abatacept) for treatment of lupus nephritis when used on a background of Cellcept (mycophenolate) and prednisone (corticosteroids)","other_id":"IM101-291","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        For additional information please contact the BMS Lupus Nephritis Clinical Trial Matching\r\n        Service at 855-56-LUPUS. Please visit www.BMSStudyConnect.com for more information on\r\n        clinical trial participation.\r\n\r\n        Note: Subjects > 16 are eligible for enrollment at selected centers\r\n\r\n        Inclusion Criteria:\r\n\r\n          -  Potential subjects must have active lupus nephritis\r\n\r\n          -  Biopsy within 12 months prior to screening visit indicating active Class 3 or 4\r\n             proliferative lupus glomerulonephritis (lupus effecting your kidney)\r\n\r\n          -  Urine protein creatinine ratio (UPCR)  1 at Screening\r\n\r\n          -  Serum creatinine  3 mg/dL (ie,  265 micromol/L)\r\n\r\n          -  There must also be evidence of active disease within 3 months of Screening, based on\r\n             at least one of the following:\r\n\r\n               -  Worsening of lupus nephritis OR\r\n\r\n               -  UPCR  3 at Screening OR\r\n\r\n               -  Active urine sediment OR\r\n\r\n               -  Biopsy within 3 months prior to screening visit indicating active Class 3 or\r\n                  Class 4 active proliferative lupus glomerulonephritis\r\n\r\n        Inclusion Criteria for the Long-Term Extension Period:\r\n\r\n          -  Signed Written Informed Consent\r\n\r\n          -  Subjects who achieve a complete or partial renal response after completing 2 years of\r\n             double-blind treatment\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Systemic Lupus Erythematosus (SLE) must be the primary/main autoimmune diagnosis\r\n\r\n          -  Current symptoms of severe, progressive, or uncontrolled non-SLE related renal,\r\n             hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or\r\n             cerebral disease, or other concomitant medical conditions that, in the opinion of the\r\n             Investigator, might place the subject at unacceptable risk for participation in this\r\n             study\r\n\r\n          -  Significant active Central nervous system (CNS) lupus with the exception of fatigue or\r\n             mild stable cognitive\r\n\r\n          -  Subjects who are diagnosed as end-stage renal disease or whose kidney damage is too\r\n             significant and irreversible\r\n      ","sponsor":"Bristol-Myers Squibb","sponsor_type":"Industry","conditions":"Lupus Nephritis","interventions":[{"intervention_type":"Biological","name":"Biological: BMS-188667"},{"intervention_type":"Drug","name":"Drug: Mycophenolate mofetil"},{"intervention_type":"Drug","name":"Drug: Prednisone"},{"intervention_type":"Biological","name":"Biological: Placebo matching with BMS-188667"}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of Participants in Complete Renal Response (CR) of Lupus Glomerulonephritis at Day 365 of the Double-blind Period","time_frame":"Day 365","description":"Number of participants achieving CR was divided by the total number of participants in that arm and expressed as a percentage. CR defined as: eGFR is normal or no <85% of the baseline; eGFR based on mean creatinine value from day 358 and 365. Proteinuria: UPCR<0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no >10 mg prednisone or equiv. for at least 28 days prior to assessment. Participants with >10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as having achieved CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use (Yes/No), race (Asian/ Black/Caucasian/Other) and baseline UPCR as a continuous variable."},{"outcome_type":"secondary","measure":"Percentage of Nephrotic Participants in Complete Renal Response of Lupus Glomerulonephritis at Day 365 of the Double-blind Period","time_frame":"Day 365","description":"Number of participants achieving CR was divided by total participants in that arm, expressed as a percentage. CR is defined the following criteria: eGFR is normal or no <85% of the baseline value; eGFR is based on mean creatinine value from day 358 and 365. Proteinuria: UPCR<0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no >10 mg prednisone or equivalent for at least 28 days prior. Subjects with >10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use, race and baseline UPCR as a continuous variable."},{"outcome_type":"secondary","measure":"Adjusted Mean Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) at Day 365 of the Double-blind Period in Nephrotic Participants","time_frame":"Baseline and Day 365","description":"Adjusted Mean Change from Baseline in UPCR at Day 365 of the double-blind period in nephrotic participants"},{"outcome_type":"secondary","measure":"Adjusted Mean Change From Baseline in UPCR at Day 365 of the Double-blind Period in Overall Population","time_frame":"Day 1 and Day 365","description":"Adjusted Mean Change from Baseline in Urine protein/creatinine ratio (UPCR) at Day 365 of the double-blind period in the overall population"},{"outcome_type":"secondary","measure":"Adjusted Mean Change From Baseline in Disease Activity as Measured by BILAG 2004 Over Time During Year 1 of the Double-blind Period","time_frame":"Day 1 to Day 365","description":"Adjusted mean change from baseline in British Isles Lupus Assessment Group (BILAG) score over time during Year 1 of the double-blind period based on a repeated measure mixed model and presented at each visit in the first 12-month of the double-blind period. BILAG index measures disease activity in different organs/systems separately. BILAG score is calculated for each of 9 systems depending on the clinical features present and whether they are new (4 points), worse (3 points), the same (2 points), improving (1 point) or not present (0 points) in the last 4 weeks compared with previously. BILAG \"A\" represents the presence of serious features of lupus. BILAG \"B\" represents more moderate features of the disease. BILAG \"C\" includes only mild symptomatic features. BILAG \"D\" represents prior activity with no current symptoms due to active lupus. BILAG \"E\" represents an organ that has never been involved. Overall BILAG score ranges from 0-108, with higher scores reflecting a worse outcome."},{"outcome_type":"secondary","measure":"Number of Participants With Any Adverse Events (AEs) During Year 1 of the Double-blind Period","time_frame":"From Day 1 up to 56 days post last dose in Year 1 of the double-blind period","description":"All AEs were coded and grouped into preferred terms (PT) by system organ class (SOC), using the Medical Dictionary for Regulatory Activities (MedDRA, version 21.0). Investigators determined the intensity of each AE as mild, moderate, severe, or very severe and assessed the relationship to study drug."},{"outcome_type":"secondary","measure":"Percentage of Participants With Ranked Outcome of Complete Renal Response, Partial Renal Response (PR), and No Renal Response (NR) During the Double-blind Period","time_frame":"Day 365, Day 729","description":"Complete Renal Response or Complete Response (CR): defined as meeting ALL of the following criteria: eGFR normal OR no less than 85% of the baseline value; UPCR < 0.5; Urine sediment: No cellular casts; Daily corticosteroid dose must be no greater than 10 mg prednisone or equivalent for at least 28 days prior to assessment. Partial Renal Response or Partial Response (PR): defined as meeting ALL of the following criteria: Participant does not meet criteria for CR; eGFR no less than 85% of the lesser of the values at screening or randomization (Day 1); UPCR < 0.5 OR 50% reduced from baseline and < 1 if baseline value was < 3, OR 50% reduced from baseline and < 3 if baseline value was greater than or equal to 3; Urine sediment: no cellular casts; daily corticosteroid dose no greater than 10 mg/day prednisone or prednisone equivalent for at least 28 days prior to assessment. No Renal Response or No Response (NR): defined as not meeting criteria for CR or PR or withdrawn"},{"outcome_type":"secondary","measure":"Median Time to Complete Renal Response During the Double-blind Period in All Participants","time_frame":"Day 365, Day 729","description":"The estimate of median time to Complete Renal Response is based on Kaplan-Meier analysis. Complete renal response (CR): defined as meeting ALL of the following criteria: eGFR normal OR no less than 85% of the baseline value; Urine protein/creatinine ratio (UPCR) < 0.5; Urine sediment: No cellular casts; Daily corticosteroid dose must be no greater than 10 mg prednisone or equivalent for at least 28 days prior to assessment."},{"outcome_type":"secondary","measure":"Median Time to Complete Renal Response During the Double-blind Period in Nephrotic Participants","time_frame":"Day 365, Day 729","description":"The estimate of median time to Complete Renal Response in nephrotic participants is based on Kaplan-Meier analysis. Complete renal response (CR): defined as meeting ALL of the following criteria: eGFR normal OR no less than 85% of the baseline value; Urine protein/creatinine ratio (UPCR) < 0.5; Urine sediment: No cellular casts; Daily corticosteroid dose must be no greater than 10 mg prednisone or equivalent for at least 28 days prior to assessment."},{"outcome_type":"secondary","measure":"Median Time to Partial Renal Response During the Double-blind Period in All Participants","time_frame":"Day 365, Day 729","description":"The estimate of median time to Partial Response (PR) is based on Kaplan-Meier analysis. Partial renal response (PR): defined as meeting ALL of the following criteria: Participant does not meet criteria for CR; eGFR no less than 85% of the lesser of the values at screening or randomization (Day 1); UPCR < 0.5 OR 50% reduced from baseline and < 1 if baseline value was < 3, OR 50% reduced from baseline and < 3 if baseline value was 3; Urine sediment: no cellular casts; daily corticosteroid dose no greater than 10 mg/day prednisone or prednisone equivalent for at least 28 days prior to assessment"},{"outcome_type":"secondary","measure":"Median Time to Partial Renal Response During the Double-blind Period in Nephrotic Participants","time_frame":"Day 365, Day 729","description":"The estimate of median time to Partial Response (PR) in nephrotic participants is based on Kaplan-Meier analysis. Partial renal response (PR): defined as meeting ALL of the following criteria: Participant does not meet criteria for CR; eGFR no less than 85% of the lesser of the values at screening or randomization (Day 1); UPCR < 0.5 OR 50% reduced from baseline and < 1 if baseline value was < 3, OR 50% reduced from baseline and < 3 if baseline value was 3; Urine sediment: no cellular casts; daily corticosteroid dose no greater than 10 mg/day prednisone or prednisone equivalent for at least 28 days prior to assessment"},{"outcome_type":"secondary","measure":"Adjusted Mean Change From Baseline in UPCR Over Time","time_frame":"Day 365; Day 729, includes data up to July 1st 2017 when double-blind therapy ended","description":"A repeated measure mixed model that included the baseline UPCR value, randomization stratification factors, time, and time by treatment interaction as fixed effects and subject as a random effect was used."},{"outcome_type":"secondary","measure":"Median Percent Change From Baseline in UPCR Over Time","time_frame":"Day 365, Day 729","description":"A repeated measure mixed model that included the baseline UPCR value, randomization stratification factors, time, and time by treatment interaction as fixed effects and subject as a random effect was used.\r\n% Change from Baseline = (post baseline - baseline value) / baseline value x 100"},{"outcome_type":"secondary","measure":"Adjusted Mean Change From Baseline in eGFR Over Time","time_frame":"Day 365, Day 729","description":"Estimated glomerular filtration rate(eGFR), will be calculated by the CKD-EPI formula shown below.50 eGFR is expressed as mL/min per 1.73m2. For the purpose of this study lower limit of normal eGFR is defined as 90mL/min per 1.73m2 eGFR = 141 X min (Scr/k, 1)α X max (Scr/k, 1)-1.209 X 0.993Age X (1.018 [if female]) X (1.159 [if black]) Where Scr is serum creatinine (mg/dL), k is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/k or 1, and max indicates the maximum of Scr/k or 1, age in years."},{"outcome_type":"secondary","measure":"Median Time to First Sustained Change to No Response During the Double-blind Period","time_frame":"Day 365, Day 729","description":"Sustained response defined as response present at 2 consecutive visits approximately 4 weeks apart. No renal response (NR): defined as not meeting criteria for CR or PR or withdrawn\r\nThe estimate of median time is based on Kaplan-Meier analysis"},{"outcome_type":"secondary","measure":"Number of Participants With Sustained Change From Higher Level of Response to no Response During the Double-blind Period","time_frame":"Day 365, Day 729","description":"Sustained change to no response is defined as going from CR (or PR) to NR and remaining in NR for at least 2 consecutive visits; visits should be approximately 4 weeks apart. This analysis will be based on time from response CR (or PR) to the first visit in which the no response (NR) was achieved and sustained to the next visit."},{"outcome_type":"secondary","measure":"Adjusted Mean Change From Baseline in Disease Activity as Measured by BILAG 2004 Over Time During the Double-blind Period","time_frame":"Day 1 to Day 729; Day 365 to Day 729","description":"BILAG index measures and reports disease activity in different organs/systems separately. The BILAG score is calculated for each of nine systems depending on the clinical features present and whether they are new (4 points), worse (3 points), the same (2 points), improving (1 point) or not present (0 points) in the last 4 weeks compared with previously. A BILAG \"A\" represents the presence of one or more serious features of lupus. A BILAG \"B\" represents more moderate features of the disease. A BILAG \"C\" includes only mild symptomatic features. A BILAG \"D\" represents only prior activity with no current symptoms due to active lupus. A BILAG \"E\" represents an organ that has never been involved. Overall BILAG score ranges from 0-108, with higher scores reflecting a worse outcome."},{"outcome_type":"secondary","measure":"Cmin (ug/mL): Trough Level Serum Concentration of Abatacept Prior to the Administration of the IV Infusion","time_frame":"Days 1 to 365","description":"Trough level serum concentration of abatacept prior to the administration of the IV infusion on Days 1 to 365"},{"outcome_type":"secondary","measure":"Cmax: Maximum Observed Serum Concentration Following Participants Receiving Active Abatacept IV","time_frame":"at 1 hour post Day 1 dose and 30 minutes post Day 337 dose","description":"Cmax: Maximum observed serum concentration following participants receiving active abatacept IV"},{"outcome_type":"secondary","measure":"AUC (TAU): Area Under the Serum Concentration Time Curve Over a Dosing Interval","time_frame":"Days 337 to 365","description":"AUC (TAU): Area under the serum concentration time curve over a dosing interval between Days 337 to 365."},{"outcome_type":"secondary","measure":"Summary Statistics for Systolic Blood Pressure","time_frame":"Day 1 to Day 729","description":"Summary statistics for systolic blood pressure"},{"outcome_type":"secondary","measure":"Summary Statistics for Diastolic Blood Pressure","time_frame":"Day 1 to Day 729","description":"Summary statistics for diastolic blood pressure"},{"outcome_type":"secondary","measure":"Summary Statistics for Heart Rate","time_frame":"Day 1 to Day 729","description":"Summary statistics for Heart Rate"},{"outcome_type":"secondary","measure":"Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (U/L)","time_frame":"Day 729","description":"Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.\r\nChange from Baseline = Post-baseline - Baseline value."},{"outcome_type":"secondary","measure":"Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (g/L)","time_frame":"Day 729","description":"Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.\r\nChange from Baseline = Post-baseline - Baseline value."},{"outcome_type":"secondary","measure":"Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (Percentage of Blood)","time_frame":"Day 729","description":"Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.\r\nChange from Baseline = Post-baseline - Baseline value."},{"outcome_type":"secondary","measure":"Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (Umol/L)","time_frame":"Day 729","description":"Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.\r\nChange from Baseline = Post-baseline - Baseline value."},{"outcome_type":"secondary","measure":"Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (mmol/L)","time_frame":"Day 729","description":"Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.\r\nChange from Baseline = Post-baseline - Baseline value."},{"outcome_type":"secondary","measure":"Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (x10^9 Cells/L)","time_frame":"Day 729","description":"Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.\r\nChange from Baseline = Post-baseline - Baseline value."},{"outcome_type":"secondary","measure":"Number of Participants With Marked Hematology Laboratory Abnormalities During Year 1 of the Double Blind Period","time_frame":"Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlier","description":"LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value HEMOGLOBIN g/L 4.0 HB >3 G/DL DECREASE FROM PRE RX HEMATOCRIT vol 6.3 HCT <0.75X PRE RX ERYTHROCYTES x10*12 c/L 5.2 RBC <0.75X PRE RX PLATELET COUNT x10*9 c/L 5.0 PLAT <0.67X LLN OR >1.5X ULN, OR IF PRE RX<LLN THEN USE 0.5X PRE RX AND <100,000/MM3 LEUKOCYTES x10*9 c/L 6.2 WBC <0.75X LLN OR >1.25X ULN, OR IF PRE RX<LLN THEN USE <0.8X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.2X PRE RX OR <LLN EOSINOPHILS (ABSOLUTE) x10*9 c/L 8.3 EOSA IF VALUE > .750 X10*3 c/uL BASOPHILS (ABSOLUTE) x10*9 c/L 8.3 BASOA IF VALUE > 400/MM3 MONOCYTES (ABSOLUTE) x10*9 c/L 8.3 MONOA IF VALUE > 2000/MM3 LYMPHOCYTES (ABSOLUTE) x10*9 c/L 8.3 LYMPA IF VALUE < .750 X10*3 c/uL OR IF VALUE > 7.50 X10*3 c/uL\r\nN = the number of participants with at least 1 on treatment lab result for each analyte"},{"outcome_type":"secondary","measure":"Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities During Year 1 of the Double Blind Period","time_frame":"Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlier","description":"LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value ALKALINE PHOSPHATASE (ALP) U/L 5.0 ALP >2X ULN, OR IF PRE RX>ULN THEN USE >3X PRE RX ASPARTATE AMINOTRANSFERASE (AST) U/L 5.0 AST >3X ULN, OR IF PRE RX>ULN THEN USE >4X PRE RX ALANINE AMINOTRANSFERASE (ALT) U/L 5.0 ALT >3X ULN, OR IF PRE RX>ULN THEN USE >4X PRE RX G-GLUTAMYL TRANSFERASE (GGT) U/L 5.0 GGT >2X ULN, OR IF PRE RX>ULN THEN USE >3X PRE RX BILIRUBIN, TOTAL umol/L 5.1 TBILI >2X ULN, OR IF PRE RX>ULN THEN USE >4X PRE RX BILIRUBIN, DIRECT umol/L 5.1 DBILI >1.5X ULN, OR IF PRE RX>ULN THEN USE >2X PRE RX BLOOD UREA NITROGEN mmol/L 5.1 BUN >2X PRE RX CREATININE umol/L 5.0 CREAT >1.5X PRE RX\r\nN = the number of participants with at least 1 on treatment lab result for each analyte"},{"outcome_type":"secondary","measure":"Number of Participants With Marked Electrolyte Laboratory Abnormalities During Year 1 of the Double Blind Period","time_frame":"Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlier","description":"LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value SODIUM, SERUM mmol/L 4.0 NA <0.95X LLN OR >1.05X ULN, OR IF PRE RX<LLN THEN USE <0.95X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.05X PRE RX OR <LLN POTASSIUM, SERUM mmol/L 4.1 K <0.9X LLN OR >1.1X ULN, OR IF PRE RX<LLN THEN USE <0.9X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.1X PRE RX OR <LLN CHLORIDE, SERUM mmol/L 5.0 CL <0.9X LLN OR >1.1X ULN, OR IF PRE RX<LLN THEN USE <0.9X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.1X PRE RX OR <LLN\r\nN = the number of participants with at least 1 on treatment lab result for each analyte"},{"outcome_type":"secondary","measure":"Number of Participants With Marked Urinalysis Laboratory Abnormalities During Year 1 of the Double Blind Period","time_frame":"Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlier","description":"LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value PROTEIN, URINE Unknown UPRO IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 GLUCOSE, URINE N/A UGLU IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 BLOOD, URINE N/A UBLD IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 RBC, URINE hpf 5.0 URBC IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 WBC, URINE hpf 5.0 UWBC IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4"},{"outcome_type":"secondary","measure":"Number of Participants With Other Marked Chemistry Laboratory Abnormalities During Year 1 of the Double Blind Period","time_frame":"Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlier","description":"LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value CALCIUM, TOTAL mmol/L 5.2 CA <0.8X LLN OR >1.2X ULN, OR IF PRE RX<LLN THEN USE <0.75X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.25X PRE RX OR <LLN PHOSPHORUS, INORGANIC mmol/L 5.2 PHOS <0.75X LLN OR >1.25X ULN, OR IF PRE RX<LLN THEN USE <0.67X PRE RX OR >ULN GLUCOSE, SERUM mmol/L 4.1 GLUC <65 mg/dL, OR >220 mg/dL PROTEIN, TOTAL g/L 5.0 TPRO <0.9X LLN OR >1.1X ULN, OR IF PRE RX<LLN THEN USE 0.9X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE 1.1X PRE RX OR <LLN ALBUMIN g/L 3.0 ALB <0.9X LLN, OR IF PRE RX<LLN THEN USE <0.75X PRE RX CHOLESTEROL, TOTAL (TC) mmol/L 5.2 CHOL >2X PRE R\r\nN = the number of participants with at least 1 on treatment lab result for each analyte"},{"outcome_type":"secondary","measure":"Number of Participants With Any Adverse Events (AEs) During Year 2 of the Double-blind Period and Long-term Extension","time_frame":"From the first dose in Year 2 of the double-blind period up to 56 days post last dose","description":"All AEs were coded and grouped into preferred terms (PT) by system organ class (SOC), using the Medical Dictionary for Regulatory Activities (MedDRA, version 21.0). Investigators determined the intensity of each AE as mild, moderate, severe, or very severe and assessed the relationship to study drug."},{"outcome_type":"secondary","measure":"Percentage of Participants in Treatment Failure Over Time During the Double-blind Period","time_frame":"Day 365, Day 729","description":"Lupus treatment failure is defined as any of the following: Death, unless due to physical trauma or violence; Renal Flare; sustained doubling of creatinine from baseline (greater of Screening or Study Day 1 value); initiation of rescue therapy for treatment of active lupus nephritis after Study Week 20.\r\nOverall treatment failure is defined as lupus treatment failure plus discontinuation of study drug for any reason except death due to physical trauma or violence, pregnancy or administrative decision by Sponsor."},{"outcome_type":"secondary","measure":"Median Time to First Treatment Failure and Overall Treatment Failure During the Double-blind Period","time_frame":"Day 365, Day 729","description":"First treatment failure (or Lupus treatment failure) is defined as any of the following: Death, unless due to physical trauma or violence; Renal Flare; sustained doubling of creatinine from baseline (greater of Screening or Study Day 1 value); initiation of rescue therapy for treatment of active lupus nephritis after Study Week 20.\r\nOverall treatment failure is defined as lupus treatment failure plus discontinuation of study drug for any reason except death due to physical trauma or violence, pregnancy or administrative decision by Sponsor.\r\nThe hazard ratio is estimated using the Cox proportional hazards model which includes treatment group, stratification variables (baseline ACEis/ARBs use, RACE) and baseline UPCR.\r\nThe estimate of median time is based on Kaplan-Meier analysis"},{"outcome_type":"secondary","measure":"Percentage of Nephrotic Participants in Complete Renal Response of Lupus Glomerulonephritis at Day 729 of the Double-blind Period","time_frame":"Day 729","description":"Number of participants achieving CR was divided by total participants in that arm, expressed as a percentage. CR is defined the following criteria: eGFR is normal or no <85% of the baseline value; eGFR is based on mean creatinine value from day 358 and 365. Proteinuria: UPCR<0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no >10 mg prednisone or equivalent for at least 28 days prior. Subjects with >10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use, race and baseline UPCR as a continuous variable."},{"outcome_type":"secondary","measure":"Percentage of Participants in Overall Population in Complete Renal Response of Lupus Glomerulonephritis at Day 729 of the Double-blind Period","time_frame":"Day 729","description":"Number of participants achieving CR was divided by total participants in that arm, expressed as a percentage. CR is defined the following criteria: eGFR is normal or no <85% of the baseline value; eGFR is based on mean creatinine value from day 358 and 365. Proteinuria: UPCR<0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no >10 mg prednisone or equivalent for at least 28 days prior. Subjects with >10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use, race and baseline UPCR as a continuous variable."},{"outcome_type":"secondary","measure":"Number of Participants With Marked Hematology Laboratory Abnormalities in the Double Blind Period","time_frame":"Day 1 to Day 729","description":"LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value HEMOGLOBIN g/L 4.0 HB >3 G/DL DECREASE FROM PRE RX HEMATOCRIT vol 6.3 HCT <0.75X PRE RX ERYTHROCYTES x10*12 c/L 5.2 RBC <0.75X PRE RX PLATELET COUNT x10*9 c/L 5.0 PLAT <0.67X LLN OR >1.5X ULN, OR IF PRE RX<LLN THEN USE 0.5X PRE RX AND <100,000/MM3 LEUKOCYTES x10*9 c/L 6.2 WBC <0.75X LLN OR >1.25X ULN, OR IF PRE RX<LLN THEN USE <0.8X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.2X PRE RX OR <LLN EOSINOPHILS (ABSOLUTE) x10*9 c/L 8.3 EOSA IF VALUE > .750 X10*3 c/uL BASOPHILS (ABSOLUTE) x10*9 c/L 8.3 BASOA IF VALUE > 400/MM3 MONOCYTES (ABSOLUTE) x10*9 c/L 8.3 MONOA IF VALUE > 2000/MM3 LYMPHOCYTES (ABSOLUTE) x10*9 c/L 8.3 LYMPA IF VALUE < .750 X10*3 c/uL OR IF VALUE > 7.50 X10*3 c/uL\r\nN = the number of participants with at least 1 on treatment lab result for each analyte"},{"outcome_type":"secondary","measure":"Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities in the Double Blind Period","time_frame":"Day 1 to Day 729","description":"LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value ALKALINE PHOSPHATASE (ALP) U/L 5.0 ALP >2X ULN, OR IF PRE RX>ULN THEN USE >3X PRE RX ASPARTATE AMINOTRANSFERASE (AST) U/L 5.0 AST >3X ULN, OR IF PRE RX>ULN THEN USE >4X PRE RX ALANINE AMINOTRANSFERASE (ALT) U/L 5.0 ALT >3X ULN, OR IF PRE RX>ULN THEN USE >4X PRE RX G-GLUTAMYL TRANSFERASE (GGT) U/L 5.0 GGT >2X ULN, OR IF PRE RX>ULN THEN USE >3X PRE RX BILIRUBIN, TOTAL umol/L 5.1 TBILI >2X ULN, OR IF PRE RX>ULN THEN USE >4X PRE RX BILIRUBIN, DIRECT umol/L 5.1 DBILI >1.5X ULN, OR IF PRE RX>ULN THEN USE >2X PRE RX BLOOD UREA NITROGEN mmol/L 5.1 BUN >2X PRE RX CREATININE umol/L 5.0 CREAT >1.5X PRE RX\r\nN = the number of participants with at least 1 on treatment lab result for each analyte"},{"outcome_type":"secondary","measure":"Number of Participants With Marked Electrolyte Laboratory Abnormalities in the Double Blind Period","time_frame":"Day 1 to Day 729","description":"LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value SODIUM, SERUM mmol/L 4.0 NA <0.95X LLN OR >1.05X ULN, OR IF PRE RX<LLN THEN USE <0.95X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.05X PRE RX OR <LLN POTASSIUM, SERUM mmol/L 4.1 K <0.9X LLN OR >1.1X ULN, OR IF PRE RX<LLN THEN USE <0.9X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.1X PRE RX OR <LLN CHLORIDE, SERUM mmol/L 5.0 CL <0.9X LLN OR >1.1X ULN, OR IF PRE RX<LLN THEN USE <0.9X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.1X PRE RX OR <LLN\r\nN = the number of participants with at least 1 on treatment lab result for each analyte"},{"outcome_type":"secondary","measure":"Number of Participants With Marked Urinalysis Laboratory Abnormalities in the Double Blind Period","time_frame":"Day 1 to Day 729","description":"LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value PROTEIN, URINE Unknown UPRO IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 GLUCOSE, URINE N/A UGLU IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 BLOOD, URINE N/A UBLD IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 RBC, URINE hpf 5.0 URBC IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 WBC, URINE hpf 5.0 UWBC IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4"},{"outcome_type":"secondary","measure":"Number of Participants With Other Marked Chemistry Laboratory Abnormalities in the Double Blind Period","time_frame":"Day 1 to Day 729","description":"LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value CALCIUM, TOTAL mmol/L 5.2 CA <0.8X LLN OR >1.2X ULN, OR IF PRE RX<LLN THEN USE <0.75X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.25X PRE RX OR <LLN PHOSPHORUS, INORGANIC mmol/L 5.2 PHOS <0.75X LLN OR >1.25X ULN, OR IF PRE RX<LLN THEN USE <0.67X PRE RX OR >ULN GLUCOSE, SERUM mmol/L 4.1 GLUC <65 mg/dL, OR >220 mg/dL PROTEIN, TOTAL g/L 5.0 TPRO <0.9X LLN OR >1.1X ULN, OR IF PRE RX<LLN THEN USE 0.9X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE 1.1X PRE RX OR <LLN ALBUMIN g/L 3.0 ALB <0.9X LLN, OR IF PRE RX<LLN THEN USE <0.75X PRE RX CHOLESTEROL, TOTAL (TC) mmol/L 5.2 CHOL >2X PRE R\r\nN = the number of participants with at least 1 on treatment lab result for each analyte"},{"outcome_type":"secondary","measure":"Number of Participants With Abatacept Induced Antibody Response Over Time in the Double-blind Period","time_frame":"Day 365, Day 729","description":"Participants who experienced a positive antibody response relative to baseline (ECL Assay)"}]}
{"nct_id":"NCT01778023","start_date":"2013-01-17","phase":"Phase 3","enrollment":54,"brief_title":"Efficacy and Safety of Recombinant Human Growth Hormone on Height Velocity in Subjects With Idiopathic Short Stature","official_title":"A 12-month, Open-labelled, Randomised, Parallel-group, Multi-centre, Interventional Trial to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone (hGH) (Norditropin Nordilet) Therapy on Height Velocity (Ht-V) in Patients With Idiopathic Short Stature in Korea","primary_completion_date":"2014-12-17","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-12-17","last_update":"2017-06-02","description":"This trial is conducted in Asia. The aim of this trial is to evaluate the efficacy and safety of recombinant human growth hormone (hGH) in subjects with idiopathic short stature in Korea.","other_id":"GH-3899","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":4,"maximum_age":11,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Informed consent obtained from subject's parents or legally acceptable representative\r\n             before any trial-related activities. (Trial-related activities are any procedure that\r\n             would not have been performed during normal management of the subject.)\r\n\r\n          -  Pre-pubertal status (males aged from 4 to 11 [both inclusive], females aged from 4 to\r\n             9 [both inclusive]): an absence of breast development in females (Tanner 1 only) and\r\n             testicular volume below 4 mL in males\r\n\r\n          -  Growth hormone level above 10 ng/mL following a stimulation test (test result within 6\r\n             months from screening can be used)\r\n\r\n          -  Height below 3 percentile\r\n\r\n          -  Bone age below or equal to 12 year\r\n\r\n          -  Epiphyses confirmed as open in patients at least 10 years or more of age\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Known presence of one or more pituitary hormone deficiencies (ACTH\r\n             (adrenocorticotropic hormone), ADH (antidiuretic hormone), FSH (follicle-stimulating\r\n             hormone), LH (luteinising hormone), TSH (thyroid-stimulating hormone))\r\n\r\n          -  Known primary hypothyroidism, adrenal insufficiency or hypogonadism (treated or\r\n             untreated)\r\n\r\n          -  Specific types of growth failure including, but not limited to, known chromosomal\r\n             abnormalities associated with growth failure and altered sensitivity to growth hormone\r\n\r\n          -  Bone age is advanced over chronological age more than 3 years\r\n\r\n          -  Active malignancy, CNS (central nervous system) trauma, active chemotherapy or\r\n             radiation therapy for neoplasia\r\n\r\n          -  Prior history of intracranial hypertension\r\n\r\n          -  Hypertrophic cardiomyopathy\r\n      ","sponsor":"Novo Nordisk A/S","sponsor_type":"Industry","conditions":"Growth Disorder|Idiopathic Short Stature","interventions":[{"intervention_type":"Drug","name":"Drug: somatropin","description":"A weekly dosage of 0.469 mg of somatropin per kg of body weight per week will be injected subcutaneously (under the skin) in the evening in 7 days per week."}],"outcomes":[{"outcome_type":"primary","measure":"Height Velocity (Ht-V)","time_frame":"After 6 months of treatment","description":"Height velocity (Ht-V) (cm/year) is the change in height per year (after 6 months of treatment). Ht-V was calculated by Novo Nordisk."},{"outcome_type":"secondary","measure":"Change in Ht-SDS (Height Standard Deviation Score)","time_frame":"After 6 months of treatment.","description":"Height standard deviation scores (HSDS) were calculated using Korean growth data (reported by the Korea Centre for Disease Control and Prevention). The mean normal range for HSDS is from -2 to +2. Negative scores below -2 indicate a height below normal range, whereas positive scores above +2 indicate a height above normal."},{"outcome_type":"secondary","measure":"Change in IGF Related Factors: IGF-I (Insulin-like Growth Factor-I)","time_frame":"After 6 months of treatment.","description":"IGF-I (insulin-like growth factor-1) was measured at Visit 1 (screening),Visit 3 (3 months ± 7 days ),Visit 4 (6 months ± 7 days),Visit 5 (9 months ± 7 days ) and Visit 6 (12 months ± 7 days ). Change of IGF-I from baseline to 6 months treatment was calculated."},{"outcome_type":"secondary","measure":"Change in IGF Related Factors: IGFBP-3 (Insulin-like Growth Factor Binding Protein-3)","time_frame":"After 6 months of treatment.","description":"IGFBP-3 was measured at Visit 1(screening), Visit 3 (3 months ± 7 days ), Visit 4 (6 months ± 7 days), 5 (9 months ± 7 days ) and 6 ( 12 months ± 7 days). Change of IGFBP-3 from baseline to 6 months treatment were calculated."},{"outcome_type":"secondary","measure":"Change in Bone Age","time_frame":"After 6 months of treatment.","description":"Change in bone age from the baseline to 6 months."},{"outcome_type":"secondary","measure":"Occurrence of Adverse Events","time_frame":"Throughout the trial (12 months)","description":"AEs were collected throughout the trial in both groups."},{"outcome_type":"secondary","measure":"Ht-V (Height Velocity)","time_frame":"At the first 6 months and the last 6 months in group A","description":"Height velocity (Ht-V) (cm/year) is the change in height per year (after 6 months of treatment). Three sort of Ht-V was calculated from height data at Visit 2 (day 0), 4 (6 months ± 7 days) and 6 (12 months ± 7 days), as follows: Between Visits 2 and 4, between Visit 4 and 6 and between Visit 2 and 6. Ht-V was calculated by Novo Nordisk. It is the difference between Ht-V for the last 6 months and Ht-V for the first 6 months of treatment. This endpoint was only evaluated for Group A as per the trial protocol."}]}
{"nct_id":"NCT01813721","start_date":"2012-12-31","enrollment":1007,"brief_title":"Study Investigating How Physicians Assess the Risk of Patients Developing Febrile Neutropenia During Chemotherapy.","official_title":"Study to Investigate Which Clinical Risk Factors Are Considered by Physicians When Conducting Overall Febrile Neutropenia Risk Assessments for Patients Receiving Chemotherapy With an Intermediate (10% - 20%) Febrile Neutropenia Risk.","primary_completion_date":"2013-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2013-12-31","last_update":"2017-03-15","description":"This is a prospective observational study investigating how physicians assess the risk of febrile neutropenia (FN) developing in patients who will receive chemotherapy. Approximately 150-200 investigators will take part in about 100 sites in Europe, Canada and Australia. Approximately 1000 subjects will be studied, all of whom will have non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), non-Hodgkin's lymphoma (NHL) or breast cancer and will be due to receive one of the specific chemotherapy regimens of interest. Investigators' approach to FN risk assessment will be studied using lists of possible risk factors they may consider during their assessment. Investigators will be asked to select and rank the factors they consider the most important when assessing the overall FN risk of a subject and when making the decision whether to treat with granulocyte-colony stimulating factor (G-CSF) primary prophylaxis (PP). They will be asked to make these selections based initially on their own routine clinical practise and subsequently relating specifically to each subject recruited. This is a non-interventional study that involves no procedures outside normal care for the subjects; all data collection will be completed prior to chemotherapy administration.","other_id":"20110146","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"Eligible subjects will have NHL, breast or lung cancer and be due to initiate one of the\r\n        permitted standard dose chemotherapy regimens listed in the protocol (those with a\r\n        documented intermediate FN risk of 10-20%). Subjects will be prospectively and sequentially\r\n        identified by approximately 150-200 investigators during their clinics distribututed in 11\r\n        countries.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age  18 years old\r\n\r\n          -  Any stage NHL, small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), or\r\n             breast cancer initiating a new chemotherapy course\r\n\r\n          -  Scheduled to receive one of the permitted standard dose chemotherapy regimens with an\r\n             estimated intermediate (10%-20%) FN risk according to published data or guidelines\r\n             (planned dose modifications +/-10% are allowable).\r\n\r\n          -  Before any study-specific procedure, the appropriate written informed consent must be\r\n             obtained where this is required by local regulations\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Ongoing or planned concurrent participation in any clinical study involving\r\n             Investigational Product that has not been approved by the European Medicines Agency\r\n             (EMA) or competent authority for any indication,\r\n\r\n          -  Ongoing or planned concurrent participation in any clinical study where the\r\n             administration of Colony Stimulating Factor (CSF) is determined by the protocol\r\n             (clinical trials on an approved drug and observational trials are permitted as long as\r\n             these do not mandate how neutropenia should be treated)\r\n\r\n          -  Prior stem-cell transplantation (includes bone marrow transplantation)\r\n      ","sponsor":"Amgen","sponsor_type":"Industry","conditions":"Chemotherapy-induced Febrile Neutropenia","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia","time_frame":"Baseline (prior to participant enrolment)","description":"During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rank the risk factors that they considered to be the most important when assessing overall febrile neutropenia (FN) risk. Age and chemotherapy regimen were specified in the protocol as risk factors of interest. Reported are age and chemotherapeutic agents ranked individually, chemotherapy agents detailed by specific factors, and age and chemotherapy agents jointly ranked. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals."},{"outcome_type":"primary","measure":"Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN)","time_frame":"Assessed at Baseline, prior to participant enrolment.","description":"During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet and asked to rank the risk factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group"},{"outcome_type":"primary","measure":"Percentage of Participants for Whom Age and Chemotherapy Regimen Were Ranked as an Important Risk Factor","time_frame":"At enrolment, prior to chemotherapy initiation","description":"Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment were collected in this study. Age and chemotherapy regimen were specified in the protocol as risk factors of interest. Reported are age and chemotherapeutic agents ranked individually, chemotherapy agents detailed by specific factors, and age and chemotherapy agents jointly ranked. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals."},{"outcome_type":"primary","measure":"Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important","time_frame":"At enrolment, prior to chemotherapy initiation.","description":"Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group."},{"outcome_type":"secondary","measure":"Percentage of Investigators Who Ranked Each Factor in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important","time_frame":"Assessed at baseline, prior to participant enrolment.","description":"During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group."},{"outcome_type":"secondary","measure":"Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty","time_frame":"Assessed at baseline, prior to participant enrolment.","description":"During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. Subgroup analyses were performed where a subgroup contained at least 40 investigators. Results are reported for medical oncologists as this was the only specialty that contained at least 40 investigators."},{"outcome_type":"secondary","measure":"Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology","time_frame":"Assessed at baseline, prior to participant enrolment.","description":"During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. Subgroup analyses were performed where a subgroup contained at least 40 investigators. ECOG = Eastern Cooperative Oncology Group."},{"outcome_type":"secondary","measure":"Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type","time_frame":"Assessed at baseline, prior to participant enrolment.","description":"During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. Subgroup analyses were performed where a subgroup contained at least 40 investigators. ECOG = Eastern Cooperative Oncology Group."},{"outcome_type":"secondary","measure":"Percentage of Participants for Whom Each Factor Was Ranked in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important","time_frame":"At enrolment, prior to chemotherapy initiation.","description":"For each participant, the investigator ranked the factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group."},{"outcome_type":"secondary","measure":"Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country","time_frame":"At enrolment, prior to chemotherapy initiation.","description":"For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not.\r\nTo account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.\r\nECOG = Eastern Cooperative Oncology Group."},{"outcome_type":"secondary","measure":"Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty","time_frame":"At enrolment, prior to chemotherapy initiation.","description":"For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not.\r\nTo account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.\r\nECOG = Eastern Cooperative Oncology Group."},{"outcome_type":"secondary","measure":"Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology","time_frame":"At enrolment, prior to chemotherapy initiation.","description":"For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not.\r\nTo account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.\r\nECOG = Eastern Cooperative Oncology Group."},{"outcome_type":"secondary","measure":"Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type","time_frame":"At enrolment, prior to chemotherapy initiation.","description":"For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not.\r\nTo account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.\r\nECOG = Eastern Cooperative Oncology Group."},{"outcome_type":"secondary","measure":"Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type","time_frame":"At enrolment, prior to chemotherapy initiation.","description":"For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not.\r\nTo account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.\r\nECOG = Eastern Cooperative Oncology Group."},{"outcome_type":"secondary","measure":"Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty","time_frame":"Assessed at Baseline, prior to participant enrolment.","description":"During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rankt the risk factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. Subgroup analyses were performed where a subgroup contained at least 40 investigators. Results are reported for medical oncologists as this was the only specialty that contained at least 40 investigators."},{"outcome_type":"secondary","measure":"Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology","time_frame":"Assessed at Baseline, prior to participant enrolment.","description":"During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rank the risk factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group."},{"outcome_type":"secondary","measure":"Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type","time_frame":"Assessed at Baseline, prior to participant enrolment.","description":"During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group."},{"outcome_type":"secondary","measure":"Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country","time_frame":"At enrolment, prior to chemotherapy initiation.","description":"Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study.\r\nTo account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.\r\nECOG = Eastern Cooperative Oncology Group."},{"outcome_type":"secondary","measure":"Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty","time_frame":"At enrolment, prior to chemotherapy initiation.","description":"Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study.\r\nTo account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.\r\nECOG = Eastern Cooperative Oncology Group."},{"outcome_type":"secondary","measure":"Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology","time_frame":"At enrolment, prior to chemotherapy initiation.","description":"Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study.\r\nTo account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.\r\nECOG = Eastern Cooperative Oncology Group."},{"outcome_type":"secondary","measure":"Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type","time_frame":"At enrolment, prior to chemotherapy initiation.","description":"Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study.\r\nTo account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.\r\nECOG = Eastern Cooperative Oncology Group."},{"outcome_type":"secondary","measure":"Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type","time_frame":"At enrolment, prior to chemotherapy initiation.","description":"Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study.\r\nTo account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.\r\nECOG = Eastern Cooperative Oncology Group."},{"outcome_type":"secondary","measure":"Percentage of Participants With an Investigator-assessed FN Risk at or Above the Investigator Self-reported FN-risk Intervention Threshold Who Were Planned to Receive G-CSF PP","time_frame":"At Baseline and at enrolment, prior to chemotherapy initiation.","description":"At Baseline investigators recorded the FN risk threshold score at which they would use G-CSF PP in their usual clinical practice. For each enrolled participant, the investigator documented their final estimated FN risk score as a percentage based on the participant's medical history and standard of care assessments (their routine practice for assessing this risk), and a decision as to whether G-CSF PP would be administered in Cycle 1."}]}
{"nct_id":"NCT02677402","start_date":"2012-12-31","phase":"N/A","enrollment":10,"brief_title":"Effects of Various Modalities Water Immersion on Veins","official_title":"Effects of Thermo Neutral Water Immersion, Cold-water Immersion and Contrast Water Therapy on Lower Limb Veins Calibres","primary_completion_date":"2013-12-31","study_type":"Interventional","rec_status":"Completed","last_update":"2016-10-27","description":"Objectives In this study the investigators examined the changes in common femoral vein (CFV) and great saphenous vein (GSV) calibre during thermo neutral water immersion (TNI), cold water immersion (CWI) and contrast water therapy (CWT). Design Ten professional handball players visited the laboratory on three occasions. At each visit, participants completed a 20-minutes procedure in an upright position: 4-minutes in air (baseline) and then 16-minutes lower limbs TNI (~35C), CWI (~12C) or CWT (2:2minutes (~12C to ~35C) ratio), selected randomly. Methods CFV and GVS calibres were evaluated by echo Doppler measures at baseline and at the end of 16 min immersion.","other_id":"H2O","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Free healthy voluntary\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  hypersensitivity to cold\r\n      ","sponsor":"University of Franche-Comt","sponsor_type":"Other","conditions":"Hydrotherapy","interventions":[{"intervention_type":"Other","name":"Other: immersion"}],"outcomes":[{"outcome_type":"primary","measure":"change in common femoral vein cross-section (mm2) during three immersion modalities immersion","time_frame":"Change from Baseline at 16 min of immersion in 3 modalities, doppler ultrasound measurements","description":"thermo neutral water immersion (TNI), cold water immersion (CWI) and contrast water therapy (CWT)"},{"outcome_type":"primary","measure":"change in great saphenous vein antero posterior diameter (mm) during three immersion modalities immersion","time_frame":"Baseline at 16 min of immersion in 3 modalities, doppler ultrasound measurements","description":"thermo neutral water immersion (TNI), cold water immersion (CWI) and contrast water therapy (CWT)"}]}
{"nct_id":"NCT01753349","start_date":"2012-12-31","enrollment":1050,"brief_title":"Phase IV-Cervical Dystonia-INTEREST IN CD2","official_title":"An International Observational Prospective Study On Long-Term Response To Botulinum Toxin Type A (BoNT-A) Injections In Subjects Suffering From Idiopathic Cervical Dystonia (CD) - Pharmaco-Economic Impact","primary_completion_date":"2017-09-30","study_type":"Observational","rec_status":"Completed","completion_date":"2017-09-25","last_update":"2020-11-05","description":"The purpose of the study is to document long-term response in real-life practice after injection cycles with BoNT-A in subjects suffering from idiopathic cervical dystonia (Long-term clinical and pharmaco-economic data).","other_id":"Y-79-52120-166","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Adult subjects from Hospitals, Private Practices suffering idiopathic cervical dystonia.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subject for whom there is an intention to treat with BoNT-A.\r\n\r\n          -  BoNT treatment nave or previously treated with BoNT.\r\n\r\n          -  If previously treated with BoNT, at least a 12-week interval between the last\r\n             injection (BoNT-A or BoNT-B) and inclusion.\r\n\r\n          -  Subject able to comply with the protocol.\r\n\r\n          -  Provision of written informed consent prior to collect the data.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Contraindications to any BoNT-A preparations.\r\n\r\n          -  The subject has already been included in the study.\r\n      ","sponsor":"Ipsen","sponsor_type":"Industry","conditions":"Cervical Dystonia","interventions":[{"intervention_type":"Biological","name":"Biological: Botulinum toxin type A","description":"Investigators were free to prescribe any BoNT A preparation, including Dysport, Botox and Xeomin."}],"outcomes":[{"outcome_type":"primary","measure":"Change in subject's satisfaction using a 5-point Likert scale.","time_frame":"Baseline and at every 3 to 4 months, up to 3 years.","description":"Identification of prognostic factors for subject's satisfaction regarding control of symptoms associated with idiopathic CD."},{"outcome_type":"secondary","measure":"Change from baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score and severity sub-scale.","time_frame":"Baseline and at every 3 to 4 months, up to 3 years.","description":"Assessment of severity of CD."},{"outcome_type":"secondary","measure":"Change in tremor associated with CD using Tsui score","time_frame":"Baseline and at every 3 to 4 months, up to 3 years."},{"outcome_type":"secondary","measure":"Change in pain relief assessed using the TWSTRS pain sub-scale.","time_frame":"Baseline and at every 3 to 4 months, up to 3 years."},{"outcome_type":"secondary","measure":"Change in disability will be measured with the TWSTRS disability sub-scale.","time_frame":"Baseline and at every 3 to 4 months, up to 3 years."},{"outcome_type":"secondary","measure":"Pharmaco-economic endpoints","time_frame":"Baseline and at every 3 to 4 months, up to 3 years.","description":"Time intervals between injections\r\nChanges in concomitant treatments for CD and associated symptoms.\r\nChanges in employment status"}]}
{"nct_id":"NCT02376660","start_date":"2012-12-31","phase":"N/A","enrollment":80,"brief_title":"Effect of Oats on Lipid Profile","official_title":"A Randomized Controlled Trial to Evaluate the Efficacy of 3 g of Soluble Fiber From Oats on the Lipid Profile of Men and Women With Elevated Lipid Levels Aged Between 20 and 50 Years","primary_completion_date":"2013-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-08-31","last_update":"2015-03-03","description":"A randomized control trial to assess the effect of oats on lipid profile of mildly hypercholesterolemic subjects. Subjects consumed 35g of oats twice daily (total of 70g / day) in place of carbohydrates as part of their usual diet. 70 grams of oats provide 3 grams of soluble fiber. Control group consumed the usual diet. Subjects followed up for 4 weeks. In total 3 assessment visits of the subjects planned for the study period.","other_id":"PEP-1205","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Men and women between 20 and 50 years old\r\n\r\n          -  Total Cholesterol:  200 mg/dL and < 240mg/dL\r\n\r\n          -  Availability and willingness to follow study protocol\r\n\r\n          -  Stable body weight for previous 3 months (not more than 5% weight change)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subjects already on lipid lowering drugs\r\n\r\n          -  LDL-c > 190 mg/dL\r\n\r\n          -  Total cholesterol <200 mg/dL and >240 mg/dL\r\n\r\n          -  Subjects with serum creatinine levels > 1.3 mg/dL (female) or 1.4 mg/dL (male),\r\n             nephropathy, evidence of hepatic disease or history of alcohol abuse\r\n\r\n          -  Baseline Triglycerides: > 300 mg/dL\r\n\r\n          -  Diabetes (Type 1 or Type 2) as diagnosed by a physician\r\n\r\n          -  Uncontrolled hyperthyroidism (as per physician's discretion)\r\n\r\n          -  Uncontrolled hypertension (as per physician's discretion)\r\n\r\n          -  Acute infections or chronic debilitating diseases like tuberculosis, malignancy, HIV\r\n             infection etc. Any life threatening serious disorder of the liver, kidneys, heart,\r\n             lungs or other organs by history\r\n\r\n          -  Irritable bowel syndrome by history\r\n\r\n          -  Unwillingness to give written informed consent for participation in the study.\r\n\r\n          -  Pregnancy & lactation (by history)\r\n\r\n          -  Severe end organ damage\r\n\r\n          -  Subjects with allergy to oats\r\n\r\n          -  Heavy smokers (smoking more than 5 cigarettes per day)\r\n      ","sponsor":"PepsiCo Global R&D","sponsor_type":"Industry","conditions":"Mildly Hypercholesterolemic Subjects","interventions":[{"intervention_type":"Other","name":"Other: Oats"}],"outcomes":[{"outcome_type":"primary","measure":"reduction of total cholesterol","time_frame":"4 weeks"},{"outcome_type":"secondary","measure":"LDL-c","time_frame":"4 weeks"},{"outcome_type":"secondary","measure":"Triglycerides","time_frame":"4 weeks"},{"outcome_type":"secondary","measure":"Blood pressure","time_frame":"4 weeks"}]}
{"nct_id":"NCT01557738","start_date":"2012-12-31","phase":"N/A","enrollment":20,"brief_title":"Role of Flavanols in Exercise and Aging","official_title":"Acute and Long-term Effects of Dietary Flavanols on Local Control of Skeletal Muscle Blood Flow During Exercise in Young and Old Humans","primary_completion_date":"2014-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-04-30","last_update":"2014-06-25","description":"It has well known that diets rich in fruits, vegetables and cocoa products are associated with positive health benefits and these positive effects have been shown to be due to compounds they contain called flavanols. Flavanols have been shown to exert their positive effects by indirectly increasing nitric oxide (NO) bioavailability. NO is a potent vasodilator that is believed to play a role in increasing blood flow to active muscle during exercise. This regulatory process is impaired with healthy aging. The underlying premise to this study is that if NO bioavailability can be increased following flavanol ingestion, will there be a restoration of blood flow during exercise in older individuals? Accordingly, the first part of this research project will compare the acute vascular effects of flavanol ingestion between a young and old group. The investigators have hypothesized that both groups will show an improvement in blood flow to active muscle during exercise, though the magnitude of the change will be greater in the older group. The second part of this project will look at the effects of 4 weeks of daily flavanol ingestion in the old group. The investigators hypothesize that subjects will demonstrate an improvement in blood flow to active muscle during exercise after the 4 week intervention and that the magnitude of the change will be greater than the acute effects. Findings from this proposal will provide evidence for the efficacy of flavanols to be used (as a simple and safe lifestyle intervention) to reverse or combat impaired blood flow regulation in older individuals.","other_id":"2012-02-0114","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Basic Science","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Males and Females between 18 - 30 years old\r\n\r\n          -  Males and Females between 60 - 80 years old\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  cardiovascular and/or microvascular disease\r\n\r\n          -  blood clotting disorder\r\n\r\n          -  pregnant lady\r\n\r\n          -  current smoker (or regularly smoked within last year)\r\n\r\n          -  a history of an adverse reaction to cold\r\n\r\n          -  taking medications known to effect the autonomic nervous system\r\n      ","sponsor":"University of Texas at Austin","sponsor_type":"Other","conditions":"Aging","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: High Flavanol Trial","description":"The experimental trial (high flavanol content) will involve the consumption of a beverage containing about 1000mg of cocoa flavanols."},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Low Flavanol Trial","description":"The placebo trial (low flavanol content) will involve the consumption of a beverage containing 75 mg of cocoa flavanols."},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: High Flavanol Trial; long-term","description":"The experimental trial (high flavanol content) will involve the daily consumption of a beverage containing about 1000mg of cocoa flavanols for 4 weeks. Subjects will be provided with 28 packets of the beverage to take home with them."},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Low Flavanol Trial; long-term effects","description":"The placebo trial (low flavanol content) will involve the daily consumption of a beverage containing 75 mg of cocoa flavanols for 4 weeks. Subjects will be provided with 28 packets to take home with them."}],"outcomes":[{"outcome_type":"primary","measure":"Change in femoral blood flow during exercise following flavanol consumption","time_frame":"During knee extension exercise, change from baseline in blood flow 2 hours post flavanol ingestion","description":"Blood flow regulation to active muscles during knee extension exercise can be assessed by using ultrasound to measure blood flow in the femoral artery. This will be done before and after stimulation of the sympathetic nervous system. A baseline value will be obtained and then the measurement will be performed again 2 hours after flavanol ingestion."},{"outcome_type":"secondary","measure":"Change in flow-mediated dilation (FMD) following flavanol consumption","time_frame":"Change from baseline in FMD 2 hours post flavanol ingestion","description":"Flow-mediated dilation is commonly used as an index of nitric oxide bioavailability. Nitric oxide is believed to play a role in blood flow regulation during exercise. A baseline value will be obtained and then the measurement will be performed again 2 hours after flavanol ingestion."}]}
{"nct_id":"NCT01728168","start_date":"2012-12-31","enrollment":183,"brief_title":"Prevalence of Food Allergies to Proteins From Different Legumes","official_title":"Prevalence of Food Allergies to Proteins From Different Legumes (Lupin, Peanut, Soy, and Pea) in Atopic and Healthy Subjects","primary_completion_date":"2013-07-31","study_type":"Observational","rec_status":"Completed","completion_date":"2013-12-31","last_update":"2014-02-04","description":"The objective of the study is to assess the prevalence of a sensitization to proteins from legumes by skin prick test using commercial extracts (peanut, soy, and pea) and raw material (lupin) in atopic and healthy subjects.","other_id":"LSEP H54-12","observational_model":"Case-Control","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":75,"population":"Male and female subjects. Age: 18 to 75 years. Subjects with Atopy or non-atopic subjects.","criteria":"\n        1. Inclusion Criteria:\r\n\r\n               -  Male and female subjects\r\n\r\n               -  Age 18 up to 75 years\r\n\r\n               -  For group \"Atopic\": either documented allergy, neurodermatitis, allergic asthma,\r\n                  allergic rhinitis, and/or a positive atopic score based on the criteria of\r\n                  Erlangen (>10 points).\r\n\r\n          2. Exclusion Criteria:\r\n\r\n               -  Intake of antihistamines, tricyclic antidepressants, systemic corticosteroids\r\n\r\n               -  Acute allergic symptoms\r\n\r\n               -  Skin infections at the test side\r\n\r\n               -  Pregnancy, lactation\r\n\r\n               -  Acute inflammatory diseases\r\n      ","sponsor":"University of Jena","sponsor_type":"Other","conditions":"Food Allergy","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Evidence of a sensitization to legume proteins","time_frame":"20 minutes after skin prick","description":"Evidence of a sensitization to one or more legume proteins (lupin, peanut, soy, and pea)"}]}
{"nct_id":"NCT01816698","start_date":"2012-12-31","phase":"Phase 3","enrollment":120,"brief_title":"Effects and Safety of Taurine Granule on Blood Pressure in Prehypertensive","official_title":"A Randomized, Double-Blind, Placebo Control Trial Comparing Effects and Safety of TAURINE GRANULE and Placebo on Blood Pressure in Prehypertensive.","primary_completion_date":"2015-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-03-31","last_update":"2015-11-24","description":"Prehypertension are associated with an increased risk of atherosclerosis and coronary artery disease, and often complicated with the metabolic disorder of glucose and lipid. The comprehensive prevention of hypertension is still an important and complex clinical issue. Taurine is one of the ingredients of Chinese medicine bezoar ,as an endogenous amino acids is central inhibitory neurotransmitter, can regulate the excitability of nerve tissue, regulate body temperature, therefore, antipyretic, sedative, analgesic, anti-inflammatory,the role of anti-rheumatic, anti-convulsant. In addition, Taurine inhibits platelet aggregation in the circulatory system, lower blood lipids, to maintain the body's normal blood pressure and prevent atherosclerosis; protective effect on myocardial cells, can be anti-arrhythmic; special efficacy to lower blood cholesterol, to treat heart failure. The effect of oral Taurine on blood pressure is not consistent, however, many animal study has shown that oral administration of Taurine, could reduce 24-hour mean arterial systolic and diastolic blood pressure in spontaneous hypertensive rats. Furthermore, Taurine interfere with calcium and low affinity binding of the calcium binding sites, decrease the voltage-dependent Ca2+channel in vascular smooth muscle relaxation, vasodilation, lower blood pressure.In a prospective, double-blind, randomized, and parallel-group study, we will evaluate the effects of Taurine granule on blood pressure and metabolic parameters in prehypertensive and mild hypertensive patients. This study will help develop future comprehensive prevention and treatment strategies for hypertension.","other_id":"GZS01167262","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":25,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Blood pressure: 120mmHgSBP<140mmHg.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Diabetes\r\n\r\n          -  Hypertension: SBP140mmHg, or DBP90mmHg.\r\n\r\n          -  known allergy to trial drugs\r\n\r\n          -  Myocardial infarction or cerebrovascular accident in the year preceding the trial\r\n\r\n          -  Clinical Congestive Heart Failure\r\n\r\n          -  Secondary hypertension\r\n\r\n          -  Pregnancy or lactating women\r\n\r\n          -  Malignant tumor\r\n\r\n          -  Gastroesophageal reflux or gastroduodenal ulcer\r\n\r\n          -  History of hepatitis or cirrhosis\r\n\r\n          -  History of kidney disease\r\n\r\n          -  Body weight35Kg\r\n      ","sponsor":"Zhiming Zhu","sponsor_type":"Other","conditions":"Prehypertension","interventions":[{"intervention_type":"Drug","name":"Drug: Taurine granule","description":"1 package(1.6g taurine granule) once a day after meals, 12 weeks"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo: 1 package once a day after meals, 12 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"The decrease in blood pressure after an 12-week oral Taurine granule administration.","time_frame":"12 weeks","description":"Evaluate the effects of Taurine granule on blood pressure and metabolic parameters in prehypertensive patients after an 12-week oral administration."}]}
{"nct_id":"NCT01949558","start_date":"2012-12-31","phase":"N/A","enrollment":110,"brief_title":"Randomized Controlled Trial of Lifestyle Intervention Postpartum in Primary Health Care","official_title":"From Efficacy to Effectiveness: Randomized Controlled Trial of Lifestyle Intervention Postpartum Among Overweight and Obese Women Within Primary Health Care in the Vastra Gotaland Region","primary_completion_date":"2017-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-09-30","last_update":"2019-09-19","description":"Chronic diseases such as overweight and cardiovascular diseases represent important threats to women's health. Pregnancy and lactation are associated with changes in weight, body composition and lipid metabolism and affect the risk of developing these chronic illnesses. Our group has conducted a randomized clinical trial (LEVA) to evaluate overweight/obese women's ability to make longterm lifestyle changes during the postpartum (pp) period, under ideal study conditions. Physiological mechanisms for weight reduction were investigated with precise methodology. However, effectiveness studies under different conditions are crucial for the development of effective programs for the Primary Health Care sector. Hence, the interest for translational research that brings results from clinical trials to the Primary Health Care sector has increased. The aim of this effectiveness-study is to investigate if dietary restrictions pp lead to significantly greater weight reduction among overweight/obese women, compared to no intervention, in a longterm perspective. In total 106 women will be recruited 10 wk pp and randomized into 1) control group; 2) dietary restrictions in individualized intervention during 12 wks. One and two years pp long term effects are evaluated. Positive results may be integrated into usual practice after the study ends.","other_id":"LIV 2011-0193","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","population":"","criteria":"\n        Inclusion Criteria * BMI at 10 w postpartum >= 27.0\r\n\r\n        Exclusion Criteria\r\n\r\n        *Serious disease in mother or child\r\n      ","sponsor":"Gteborg University","sponsor_type":"Other","conditions":"Overweight|Obesity","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Dietary Intervention"}],"outcomes":[{"outcome_type":"primary","measure":"body weight","time_frame":"1 and 2 yrs post intervention start"},{"outcome_type":"secondary","measure":"Cost-effectiveness","time_frame":"1 and 2 years post intervention start"},{"outcome_type":"other","measure":"Reported dietary intake","time_frame":"1 and 2 yrs post intervention start","description":"Reported dietary intake by 24 hr recall"},{"outcome_type":"other","measure":"Physical activity","time_frame":"1 yr after start of intervention","description":"Step counter worn during 5 days"},{"outcome_type":"other","measure":"Quality of Life as measured by two validated scales","time_frame":"1 and 2 yrs after intervention start","description":"Participants fill in EQ-5D, which is a validated scale often used to calculate QoL"},{"outcome_type":"other","measure":"TLC, Transformative Lifestyle Change","time_frame":"At start and end of intervention","description":"Questions on TLC"},{"outcome_type":"other","measure":"Quality of Life as measured by SF-36","time_frame":"1 and 2 years after intervention start","description":"participants fill in SF-36, which is a validated scale, to calculate QoL"}]}
{"nct_id":"NCT02180373","start_date":"2012-12-31","enrollment":2000,"brief_title":"PREDICT-PVI Understanding Peripheral Restenosis: Genomic and Proteomic Determinants of Vascular Intervention","official_title":"Understanding Peripheral Restenosis: Genomic and Proteomic Determinants of Vascular Intervention","primary_completion_date":"2017-12-31","study_type":"Observational [Patient Registry]","rec_status":"Unknown status","completion_date":"2017-12-31","last_update":"2014-07-03","description":"The overall goal of this multicenter collaborative research study is to identify genetic, proteomic, and/or lipidic (lipidomic) biomarkers associated with the outcomes of lower extremity revascularization in patients with advanced peripheral artery disease (PAD).","other_id":"VCures","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients with advanced peripheral artery disease already undergoing treatment by\r\n        participating vascular surgeons, who are either having vein graft (VG) bypass or\r\n        superficial femoral artery (SFA) stenting. These procedures are unrelated to this study.\r\n        Enrollment is at the discretion of the participating vascular surgeon in addition to\r\n        meeting inclusion criteria.","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age of at least 18 years.\r\n\r\n          2. Provision of written informed consent for biospecimen storage, broad genetic and\r\n             proteomic analysis of tissues, without restrictions, and correlation with clinical\r\n             outcome data.\r\n\r\n          3. Willingness to undergo all study collection procedures and sample analyses\r\n\r\n             . VG BYPASS COHORT\r\n\r\n        1. Patient requires placement of an infrainguinal vein bypass graft for the treatment of\r\n        chronic peripheral artery occlusive disease (PAD). Disabling claudication or critical limb\r\n        ischemia are acceptable indications.\r\n\r\n        2. Adequate vein conduit (saphenous vein or alternative vein/spliced vein grafts) for\r\n        bypass available based on preoperative surgical and/or ultrasound assessment.\r\n\r\n        SFA COHORT:\r\n\r\n          1. Patient requires placement of a superficial femoral artery stent for the treatment of\r\n             chronic peripheral artery occlusive disease (PAD). Disabling claudication or critical\r\n             limb ischemia are acceptable indications.\r\n\r\n          2. TransAtlantic Intersociety Consensus (TASC) A-C lesions (must be >70% by visual\r\n             estimate) amenable to bare metal or drug-eluting stent placement. Stent manufacturer\r\n             is at the discretion of the treating physician; stents to be used must be commercially\r\n             available and, if drug-eluting, FDA-approved for SFA use .\r\n\r\n          3. Must have at least one patent outflow vessel to the foot.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Anticipated life expectancy less than 2 years.\r\n\r\n          2. Undergoing active treatment for advanced malignancy (e.g. metastatic disease).\r\n\r\n          3. On immunosuppressive therapy for solid organ transplant or other indications.\r\n\r\n          4. Known or suspected hypercoagulable state.\r\n\r\n          5. Unable or unwilling to be compliant with the follow-up assessments.\r\n\r\n        VG BYPASS COHORT\r\n\r\n          1. Use of any non-autogenous conduit or revision of a pre-existing graft.\r\n\r\n          2. Bypass performed for other than chronic atherosclerotic occlusive disease (e.g.\r\n             arteritis, aneurysm, acute limb ischemia or trauma).\r\n\r\n          3. Combined endovascular intervention during same procedure (i.e. hybrid procedure)\r\n             except for treatment of ipsilateral TASC A/B iliac disease.\r\n\r\n        SFA STENT COHORT\r\n\r\n          1. Stent placement performed for other than chronic atherosclerotic occlusive disease\r\n             (e.g. arteritis, aneurysm, acute limb ischemia, or trauma).\r\n\r\n          2. TASC D disease (total SFA occlusion or occlusion with severe calcification not\r\n             amenable to stent placement).\r\n\r\n          3. Previous SFA stent placement.\r\n\r\n          4. Use of stent graft.\r\n\r\n          5. Lesions requiring stent placement > 1cm below the tibial plateau.\r\n\r\n          6. Known or suspected allergy to nickel.\r\n\r\n          7. Pregnancy.\r\n\r\n             -\r\n      ","sponsor":"Vascular Cures","sponsor_type":"Other","conditions":"Peripheral Artery Disease","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Revascularization required","time_frame":"2 years","description":"observation is to identify biomarkers of vascular healing"}]}
{"nct_id":"NCT01670084","start_date":"2012-12-31","phase":"Phase 2","enrollment":0,"brief_title":"Nilotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia or Blastic Phase Chronic Myelogenous Leukemia","official_title":"A Phase II Study of Combination Nilotinib and Hyper-CVAD in Patients Newly Diagnosed With Philadelphia-Chromosome Positive Acute Lymphoblastic Leukemia or Chronic Myeloid Leukemia Blast-Phase Lymphoid Lineage","primary_completion_date":"2015-09-30","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2017-09-30","last_update":"2015-10-30","description":"In this study researchers want to find out more about the side effects of a new drug for Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) and chronic myelogenous leukemia (CML) blastic phase (BP) and if this disease will respond better to nilotinib combined with standard hyper-CVAD therapy rather than hyper-CVAD alone. Hyper-CVAD is a combination of cyclophosphamide, mesna, vincristine (vincristine sulfate), doxorubicin (doxorubicin hydrochloride), dexamethasone, methotrexate, cytarabine, and rituximab (only for patients with cluster of differentiation [CD]20 positive disease). Researchers don't know all the ways that this drug may affect people","other_id":"MC1184","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Untreated, histological confirmed Philadelphia positive B-cell acute lymphoblastic\r\n             leukemia or chronic myeloid leukemia blast-phase lymphoid lineage (bilineal,\r\n             biphenotypic or undifferentiated) per World Health Organization (WHO) criteria; NOTE:\r\n             Dexamethasone (or corticosteroids) use is allowed if needed before starting\r\n             chemotherapy; prior imatinib or dasatinib therapy for CML chronic phase (CP) or\r\n             accelerated phase (AP) is allowed\r\n\r\n          -  Molecular or cytogenetic documentation of BCR-ABL fusion gene via any of the\r\n             following: reverse transcriptase-polymerase chain reaction (RT-PCR), G-banding, or\r\n             fluorescence in situ hybridization (FISH) testing from peripheral blood and/or bone\r\n             marrow sampling\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2\r\n\r\n          -  Magnesium/potassium/phosphorus within normal limits (WNL)\r\n\r\n          -  Serum amylase =< 1.5 x upper limit of normal (ULN)\r\n\r\n          -  Lipase =< 1.5 x ULN\r\n\r\n          -  Total bilirubin < 1.5 x ULN (does not apply to patients with isolated\r\n             hyperbilirubinemia [e.g., Gilbert's disease], in this situation the direct bilirubin\r\n             =< 2 x ULN)\r\n\r\n          -  Alkaline phosphatase =< 3 x ULN\r\n\r\n          -  Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 3\r\n             x ULN\r\n\r\n          -  Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x ULN\r\n\r\n          -  Creatinine =< 1.5 x ULN\r\n\r\n          -  Negative serum pregnancy test done =< 7 days prior to registration, for women of\r\n             childbearing potential only\r\n\r\n          -  Provide informed written consent\r\n\r\n          -  Willing to return to Mayo Clinic Rochester or Mayo Clinic Arizona for follow-up during\r\n             the active monitoring phase of the study\r\n\r\n          -  Willing to provide CSF and blood samples for correlative research purposes\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any of the following because this study involves investigational agent(s) whose\r\n             genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are\r\n             unknown:\r\n\r\n               -  Pregnant women\r\n\r\n               -  Nursing women\r\n\r\n               -  Men or women of childbearing potential who are unwilling to employ adequate\r\n                  contraception throughout the study and for 3 months after completion of study\r\n                  treatment\r\n\r\n          -  Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment\r\n             of the investigator, would make the patient inappropriate for entry into this study or\r\n             interfere significantly with the proper assessment of safety and toxicity of the\r\n             prescribed regimens\r\n\r\n          -  Immunocompromised patients (other than that related to the use of corticosteroids)\r\n             including patients known to be human immunodeficiency virus (HIV) positive (even if on\r\n             highly active antiretroviral therapy [HAART])\r\n\r\n          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active\r\n             infection, or psychiatric illness/social situations that would limit compliance with\r\n             study requirements\r\n\r\n          -  Receiving any other investigational agent which would be considered as a treatment for\r\n             the primary neoplasm\r\n\r\n          -  Other active malignancy =< 3 years prior to registration; EXCEPTIONS: Non-melanotic\r\n             skin cancer or carcinoma-in-situ of the cervix\r\n\r\n          -  History of myocardial infarction =< 12 months, or congestive heart failure requiring\r\n             use of ongoing maintenance therapy for life-threatening ventricular arrhythmias\r\n\r\n          -  Previous treatment with chemotherapy or any other tyrosine kinase inhibitor (prior\r\n             imatinib or dasatinib for CML-CP/-AP is allowed)\r\n\r\n          -  Impaired cardiac function including any one of the following:\r\n\r\n               -  Inability to monitor the QT interval on electrocardiogram (ECG)\r\n\r\n               -  Congenital long QT syndrome or a known family history of long QT syndrome\r\n\r\n               -  Cardiac ejection fraction (EF) < 45%\r\n\r\n               -  Clinically significant resting brachycardia (< 50 beats per minute)\r\n\r\n               -  Corrected QT interval (QTc) > 450 msec on baseline ECG; if QTc > 450 msec and\r\n                  electrolytes are not within normal ranges, electrolytes should be corrected and\r\n                  then the patient re-screened for QTc\r\n\r\n               -  Other clinically significant uncontrolled heart disease (e.g. unstable angina,\r\n                  congestive heart failure or uncontrolled hypertension)\r\n\r\n               -  History of or presence of clinically significant ventricular or atrial\r\n                  tachyarrhythmias\r\n\r\n          -  Patients receiving any medications or substances that are strong or moderate\r\n             inhibitors of cytochrome P450 3A4 (CYP3A4); use of the following strong or moderate\r\n             inhibitors are prohibited =< 7 days prior to registration:\r\n\r\n               -  Strong Inhibitors of CYP3A4; > 5-fold increase in the plasma area under the curve\r\n                  (AUC) values or more than 80% decrease in clearance\r\n\r\n                    -  Indinavir (Crixivan)\r\n\r\n                    -  Nelfinavir (Viracept)\r\n\r\n                    -  Atazanavir (Reyataz)\r\n\r\n                    -  Ritonavir (Norvir)\r\n\r\n                    -  Clarithromycin (Biaxin, Biaxin XL)\r\n\r\n                    -  Itraconazole (Sporanox)\r\n\r\n                    -  Ketoconazole (Nizoral)\r\n\r\n                    -  Nefazodone (Serzone)\r\n\r\n                    -  Saquinavir (Fortovase, Invirase)\r\n\r\n                    -  Telithromycin (Ketek)\r\n\r\n               -  Moderate Inhibitors of CYP3A4; > 2-fold increase in the plasma AUC values or\r\n                  50-80% decrease in clearance\r\n\r\n                    -  Aprepitant (Emend)\r\n\r\n                    -  Erythromycin (Erythrocin, E.E.S. , Ery-Tab, Eryc, EryPed, PCE)\r\n\r\n                    -  Fluconazole (Diflucan)\r\n\r\n                    -  Grapefruit juice\r\n\r\n                    -  Verapamil (Calan, Calan SR, Covera-HS, Isoptin SR, Verelan, Verelan\r\n                       PM)\r\n\r\n                    -  Diltiazem (Cardizem, Cardizem CD, Cardizem LA, Cardizem SR, Cartia XT,\r\n                       Dilacor XR, Diltia XT, Taztia XT, Tiazac)\r\n\r\n          -  Patients receiving any medications or substances that are inducers of CYP3A4; use of\r\n             the following inducers are prohibited =< 7 days prior to registration\r\n\r\n             * Inducers of CYP3A4\r\n\r\n               -  Efavirenz (Sustiva)\r\n\r\n               -  Nevirapine (Viramune)\r\n\r\n               -  Carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Tegretol-XR)\r\n\r\n               -  Modafinil (Provigil)\r\n\r\n               -  Phenobarbital (Luminal)\r\n\r\n               -  Phenytoin (Dilantin, Phenytek)\r\n\r\n               -  Pioglitazone (Actos)\r\n\r\n               -  Rifabutin (Mycobutin)\r\n\r\n               -  Rifampin (Rifadin)\r\n\r\n               -  St. John's wort\r\n\r\n          -  Patients currently receiving treatment with any medications that have the potential to\r\n             prolong the QT interval and the treatment cannot be either discontinued or switched to\r\n             a different medication prior to starting study drug\r\n\r\n          -  Impaired gastrointestinal (GI) function or GI disease that may significantly alter the\r\n             absorption of study drug (e.g., ulcerative diseases, uncontrolled nausea, vomiting,\r\n             diarrhea, malabsorption syndrome, small bowel resection or gastric bypass surgery)\r\n\r\n          -  Acute or chronic pancreatic disease\r\n\r\n          -  Known cytopathologically confirmed central nervous system (CNS) infiltration\r\n\r\n          -  Acute or chronic liver disease or severe renal disease considered unrelated to the\r\n             cancer\r\n\r\n          -  History of significant congenital or acquired bleeding disorder unrelated to cancer\r\n\r\n          -  Major surgery =< 4 weeks prior to registration or not recovered from prior surgery\r\n\r\n          -  Treatment with other investigational agents =< 14 days of registration\r\n      ","sponsor":"Mayo Clinic","sponsor_type":"Other","conditions":"B-cell Adult Acute Lymphoblastic Leukemia|Blastic Phase Chronic Myelogenous Leukemia|Chronic Myelogenous Leukemia, BCR-ABL1 Positive|Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia|Untreated Adult Acute Lymphoblastic Leukemia","interventions":[{"intervention_type":"Drug","name":"Drug: nilotinib","description":"Given PO"},{"intervention_type":"Biological","name":"Biological: rituximab","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: cyclophosphamide","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: doxorubicin hydrochloride","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: vincristine sulfate","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: methotrexate","description":"Given IV or IT"},{"intervention_type":"Drug","name":"Drug: cytarabine","description":"Given IV or IT"},{"intervention_type":"Drug","name":"Drug: prednisone","description":"Given PO"},{"intervention_type":"Drug","name":"Drug: mesna","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: dexamethasone","description":"Given IV or PO"},{"intervention_type":"Drug","name":"Drug: leucovorin calcium","description":"Given IV"}],"outcomes":[{"outcome_type":"primary","measure":"Disease-free survival rate, defined as a patient who is alive and relapse-free, in patients who achieve a CR during the first 2 courses out to 2 years","time_frame":"2 years","description":"The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportion will be calculated."},{"outcome_type":"secondary","measure":"Overall survival time, defined as the time from registration to death due to any cause out to 2 years","time_frame":"2 years"},{"outcome_type":"secondary","measure":"Complete response (CR) rate estimated by the number of patients achieving an objective status of CR during the first 2 courses of treatment divided by the total number of evaluable patients","time_frame":"56 days"},{"outcome_type":"secondary","measure":"Complete response (CR) as defined for all evaluable patients who have achieved a CR as the date at which the patient's objective status is first noted to be a CR to the earliest date relapse is documented out to 4 years","time_frame":"Up to 4 years"},{"outcome_type":"secondary","measure":"Maximum grade for each type of adverse event, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0","time_frame":"Up to 30 days after last dose of study drug"}]}
{"nct_id":"NCT01756430","start_date":"2012-12-31","phase":"Phase 3","enrollment":238,"brief_title":"Efficacy and Safety of Carvedilol SR Versus Carvedilol IR in Patients With Essential Hypertension","official_title":"A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of Carvedilol SR Versus Carvedilol IR in Patients With Essential Hypertension","primary_completion_date":"2013-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-09-30","last_update":"2014-01-14","description":"The aim of present study is to evaluate the efficacy and safety of Carvedilol SR versus Carvedilol IR in Patients With Essential Hypertension","other_id":"125HT12001","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  age 18 years or older\r\n\r\n          -  at the screening visit(visit 1)\r\n\r\n               -  antihypertensive drugs not taking: 90mmHg  mean sitDBP  109mmHg and mean sitSBP\r\n                  < 180mmHg\r\n\r\n               -  antihypertensive drugs taking: mean sitDBP  104mmHg and mean sitSBP < 180mmHg\r\n\r\n          -  at the randomization visit(visit 2): 90mmHg  mean sitDBP  109mmHg and mean sitSBP <\r\n             180mmHg\r\n\r\n          -  willing and able to provide written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. At Screening, difference in measured blood pressure of the selected arm(sitDBP \r\n             10mmHg or sitSBP  20mmHg)\r\n\r\n          2. known or suspected secondary hypertension(ex. aortic coarctation, Primary\r\n             hyperaldosteronism, renal artery stenosis, pheochromocytoma)\r\n\r\n          3. Type I Diabetes Mellitus, Type II Diabetes Mellitus with poor glucose control as\r\n             defined by fasting glucosylated hemoglobin(HbA1c > 9%)\r\n\r\n          4. Corresponding to the following\r\n\r\n               -  has severe heart disease(Heart failure NYHA functional class 3, 4)\r\n\r\n               -  ischaemic heart diseases within 6 months (unstable angina or myocardial\r\n                  infarction)\r\n\r\n               -  myocardiopathy\r\n\r\n               -  Cor pulmonale\r\n\r\n               -  aortic stenosis , aortic valvular stenosis , mitral stenosis\r\n\r\n               -  abnormality of the conduction system as 2nd degree AV block, Complete AV block,\r\n                  Sick Sinus Syndrome, Sinus Block(In particular, pulse <50beats / min)\r\n\r\n               -  has heart attack with complication.\r\n\r\n          5. has cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6\r\n             months\r\n\r\n          6. has edema glottitis, allergic rhinitis, Respiratory diseases as Asthma, Chronic\r\n             Obstructive Pulmonary Disease.\r\n\r\n          7. Peripheral circulatory disturbance( ex. Raynaud syndrome, intermittent claudication)\r\n\r\n          8. Fluid retention or overload to required intravenous inotropes.\r\n\r\n          9. known severe or malignant retinopathy(retinal hemorrhage, visual disturbance, Retinal\r\n             microaneurysms and so on within 6 months)\r\n\r\n         10. defined by the following laboratory parameters:\r\n\r\n               -  hepatic dysfunction(AST/ALT  UNL X 3)\r\n\r\n               -  renal dysfunction(serum creatinine  UNL X 2)\r\n\r\n         11. any surgical or medical condition which might significantly alter the absorption,\r\n             distribution, metabolism, or excretion of investigational products(ex.\r\n             gastrointestinal tract surgery such as gastrectomy, gastroenterostomy or bypass,\r\n             active inflammatory bowel syndrome within 12 months prior to screening, gastric ulcers\r\n             need to treatment, gastrointestinal/rectal bleeding, impaired pancreatic function such\r\n             as pancreatitis, obstructions of the urinary tract or difficulty in voiding)\r\n\r\n         12. history of drug or alcohol dependency within 6 months\r\n\r\n         13. premenopausal women(last menstruation < 12 months) not using adequate contraception,\r\n             pregnant or breast-feeding\r\n\r\n         14. chronic inflammatory status need to treatment\r\n\r\n         15. known hypersensitivity related to carvedilol\r\n\r\n         16. history of malignancy including leukemia and lymphoma within the past 5 years\r\n\r\n         17. administration of other study drugs within 28 days prior to the first IP\r\n             administration\r\n\r\n         18. in investigator's judgment\r\n      ","sponsor":"Chong Kun Dang Pharmaceutical","sponsor_type":"Industry","conditions":"Hypertension","interventions":[{"intervention_type":"Drug","name":"Drug: Carvedilol SR 32mg, QD","description":"Carvedilol SR 32mg QD for 4 weeks\r\nWith the others investigation product placebo 1 capsule QD and 1 tablet BID for 4 weeks."},{"intervention_type":"Drug","name":"Drug: Carvedilol SR 64mg, QD","description":"Carvedilol SR 64mg QD for 4 weeks\r\nWith the others investigation product placebo 1 capsule QD and 1 tablet BID for 4 weeks."},{"intervention_type":"Drug","name":"Drug: Carvedilol IR 25mg, QD","description":"Carvedilol IR 25mg QD for 4 weeks\r\nWith the others investigation product placebo 2 capsules and 1 tablet QD for 4 weeks."},{"intervention_type":"Drug","name":"Drug: Carvedilol IR 25mg, BID","description":"Carvedilol IR 25mg BID for 4 weeks\r\nWith the others investigation product placebo 2 capsules QD for 4 weeks."}],"outcomes":[{"outcome_type":"primary","measure":"Mean Sitting Diastolic Blood Pressure (MSDBP)","time_frame":"After 4 and 8 weeks of treatment"},{"outcome_type":"secondary","measure":"Mean Sitting systolic Blood Pressure (MSSBP)","time_frame":"After 4 weeks and 8 weeks of treatment"},{"outcome_type":"secondary","measure":"Control Rate","time_frame":"After 8 weeks of treatment","description":"Sitting DBP<90mmHg, Sitting SBP<140mmHg"},{"outcome_type":"secondary","measure":"Response Rate","time_frame":"After 8 weeks of treatment","description":"Reduction of Sitting DBP≥10mmHg, Sitting SBP ≥20mmHg"}]}
{"nct_id":"NCT01678586","start_date":"2012-12-31","phase":"N/A","enrollment":47,"brief_title":"Effect of Acupuncture and Pain Medication on Radicular Pain Using QST","official_title":"Effect of Acupuncture and Pain Medication on Radicular Pain Using QST","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2021-12-31","last_update":"2021-01-08","description":"In this aim, we propose to conduct a double blinded, placebo-controlled, and randomized clinical trial to compare the clinical effectiveness of radicular pain relief by either acupuncture therapy or a course of pain medication (e.g., Gabapentin) using Quantitative Sensory Testing (QST).","other_id":"2012P-001795","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Subject will be between ages 18 to 75 years. Both male and female subjects will be\r\n             recruited.\r\n\r\n          2. Subject should have had cervical or lumbar radicular pain for at least two months.\r\n             This requirement is to avoid the uncertainty of an unstable pain condition and to\r\n             minimize the study variation.\r\n\r\n          3. Subject has a pain score of 4 or above (visual analog scale, VAS: 0 - 10 from no pain\r\n             to worst pain).\r\n\r\n          4. Cervical or lumbar radicular pain will include, but is not limited to, such clinical\r\n             conditions as disk herniation, spinal stenosis, and post-laminectomy syndrome.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Subject has detectable sensory deficits at the site of QST. Sensory deficits refer to\r\n             such conditions resulting from neurological diseases or medical conditions causing\r\n             peripheral polyneuropathy and sensory changes, which include but are not limited to\r\n             diabetic neuropathy, alcoholic neuropathy, AIDS neuropathy, severe thyroid disease,\r\n             and severe liver or kidney disorders.\r\n\r\n          2. Subject has scar tissue, infection, or acute injury at the site of QST.\r\n\r\n          3. Subject is pregnant.\r\n\r\n          4. Subject tests positive for illicit drugs.\r\n\r\n          5. Subject has a pacemaker.\r\n\r\n          6. Subject is currently taking gabapentin.\r\n      ","sponsor":"Massachusetts General Hospital","sponsor_type":"Other","conditions":"Pain","interventions":[{"intervention_type":"Other","name":"Other: Acupuncture","description":"In true acupuncture the needles penetrate the skin."},{"intervention_type":"Other","name":"Other: Sham Acupuncture","description":"In sham acupuncture the needles do not penetrate the skin."},{"intervention_type":"Drug","name":"Drug: Gabapentin","description":"Gabapentin is a commonly prescribed drug used to treat neuropathic pain."},{"intervention_type":"Drug","name":"Drug: Sham Gabapentin","description":"Benadryl or diphenhydramine is used as a placebo as it could mimic some common side effects of gabapentin (i.e. sedation, drowsiness, lightheadedness)"}],"outcomes":[{"outcome_type":"primary","measure":"Changes in QST measures in response to acupuncture or gabapentin","time_frame":"3 weeks","description":"Changes in response to heat stimulation stated as pain, sensitivity and tolerance. Responses are measured with a quantitative sensory testing (QST) device. Measurements are taken before, during, and after acupuncture treatment and throughout the gabapentin medication regimen."}]}
{"nct_id":"NCT02217293","start_date":"2012-11-30","phase":"N/A","enrollment":44,"brief_title":"Efficacy of Pulsed Radiofrequency of the Median Nerve Under Ultrasound Guidance in Patients With Carpal Tunnel Syndrome","official_title":"Efficacy of Pulsed Radiofrequency of the Median Nerve Under Ultrasound Guidance in Patients With Carpal Tunnel Syndrome","primary_completion_date":"2013-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-09-30","last_update":"2014-08-15","description":"Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy. Although many conservative forms of management including the use of wrist splint, steroid injections and therapeutic ultrasound are applicable, their effectiveness is typically insignificant or short-lived. Pulsed radiofrequency (PRF) treatment, a relative novel pain intervention at recent decade, was found to be able to alleviate pain for certain kinds of chronic pain conditions without damaging nerve. However, the application of PRF in CTS is scarce. The purpose of this study was to assess the analgesic effect and prognosis of ultrasound-guided PRF in the median nerve in patients with CTS.","other_id":"TSGHIRB: 1-101-05-049","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Outpatient subjects who had typical symptoms and signs of CTS, such as positive\r\n             Tinel's sign or Phalen's test and numbness/tingling in at least two of the first,\r\n             second, and third digits and were all confirmed by electrophysiological study, were\r\n             considered and enrolled.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  The patients who had conditions mimicking CTS, such as cervical radiculopathy,\r\n             polyneuropathy, brachial plexopathy, thoracic outlet syndrome or who had previous\r\n             wrist surgery or steroid injection for CTS\r\n      ","sponsor":"Tri-Service General Hospital","sponsor_type":"Other","conditions":"Carpal Tunnel Syndrome","interventions":[{"intervention_type":"Device","name":"Device: Pulsed Radiofrequency","description":"Pulsed radiofrequency (PRF) treatment, a relative novel pain intervention at recent decade, was found to be able to alleviate pain by delivering an electrical field and heat bursts at a temperature less than 42C to neural tissue in the absence of neural injury. The ultrasound-guided PRF was performed before night splint in intervention group."}],"outcomes":[{"outcome_type":"primary","measure":"Change from baseline of pain on1st, 4th, 8th and 12th weeks after treatment.","time_frame":"Pre-treatment, 1st, 4th, 8th and 12th weeks after treatment.","description":"Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment."},{"outcome_type":"secondary","measure":"Change from baseline in severity of symptoms and functional status on 1st, 4th, 8th and 12th weeks after treatment.","time_frame":"Pre-treatment, 1st, 4th, 8th and 12th weeks after treatment.","description":"Using the Boston Carpal Tunnel Syndrome Questionnaire to measure the symptoms and functional status before treatment and multiple time frame after treatment."},{"outcome_type":"secondary","measure":"Change from baseline in cross-sectional area of the median nerve on 1st, 4th, 8th and 12th weeks after treatment.","time_frame":"Pre-treatment, 1st, 4th, 8th and 12th weeks after treatment.","description":"Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve."},{"outcome_type":"secondary","measure":"Change from baseline in conduction velocity, ampliture of median nerve on 1st, 4th, 8th and 12th weeks after treatment.","time_frame":"Pre-treatment, 1st, 4th, 8th and 12th weeks after treatment.","description":"The antidromic sensory nerve conduction velocityof the median nerve was performed on all subjects according to the protocol reported by the American Academy of Neurology with SierraWave, Cadwell (USA). The median nerve was stimulated at the wrist between the palmar longus and flexor carpal radialis tendon at a distance of approximately 14 cm from the active electrode."},{"outcome_type":"secondary","measure":"Change from baseline in finger pinch on 1st, 4th, 8th and 12th weeks after treatment.","time_frame":"Pre-treatment, 1st, 4th, 8th and 12th weeks after treatment.","description":"The finger pinch strength was measured using Jamar dynamometer (Fabrication Enterprises Inc., USA). The subject was seated with shoulder adducted and neutrally rotated with the elbow flexed at 90°. The forearm and wrist were positioned in a neutral position for the palmar pinch"}]}
{"nct_id":"NCT01777464","start_date":"2012-11-30","phase":"N/A","enrollment":14,"brief_title":"Role of the Central Nervous System in Allergic Rhinitis","official_title":"Role of the Central Nervous System in Allergic Rhinitis: Activation of Different Brain Regions After a Nasal Histamine Provocation in Healthy and Allergic Patients","primary_completion_date":"2016-02-29","study_type":"Interventional","rec_status":"Terminated","completion_date":"2016-03-31","last_update":"2015-12-03","description":"In order to evaluate the effects a nasal provocation on the activation of different brain regions, the investigators want to set up a clinical trial investigating the short-term effects of a nasal histamine provocation in healthy volunteers and allergic patients while in supine position under the functional MRI device in order to visualize different brain regions.","other_id":"september2012","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with a positive skin prick test to grass pollen and with pollen allergic\r\n             symptoms during the pollen season OR patients with a negative skin prick test and with\r\n             no allergic symptoms during the pollen season.\r\n\r\n          -  Age > 18 and < 50 years\r\n\r\n          -  Written informed consent\r\n\r\n          -  Willingness to adhere to visit schedules\r\n\r\n          -  Adequate contraceptive precautions in female patients with childbearing potential\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Current or recent (finished less than 2 years) immunotherapy against grass pollen.\r\n\r\n          -  Systemic steroid treatment less than 6 weeks before the inclusion in the study.\r\n\r\n          -  Nasal steroid spray, oral leukotriene antagonists or long-acting antihistamines less\r\n             than 4 weeks before the inclusion.\r\n\r\n          -  Presence of purulent secretions in nasal cavity.\r\n\r\n          -  Severe septal deviation (septum reaching concha inferior or lateral nasal wall).\r\n\r\n          -  Patient is pregnant or breastfeeding.\r\n\r\n          -  Patient has any disorder of which the investigators feel at the time of evaluation for\r\n             participation in the study that this may compromise the ability to give truly informed\r\n             consent for participation in this study.\r\n\r\n          -  Patient is currently enrolled in other investigational drug trial(s) or is receiving\r\n             other investigational agent(s) for any other medical condition.\r\n\r\n          -  No independent medication management in daily life or disability to perform fine\r\n             motoric handling of medication\r\n\r\n          -  Patients with asthma will be excluded.\r\n\r\n          -  Patients suffering from claustrophobia\r\n      ","sponsor":"Universitaire Ziekenhuizen Leuven","sponsor_type":"Other","conditions":"House Dust Mite Allergy","interventions":[{"intervention_type":"Biological","name":"Biological: histamine","description":"administration of histamine solution (16 mg/ml) via aerosol for 5 minutes while lying under a fMRI scan"},{"intervention_type":"Biological","name":"Biological: sham","description":"sham solution"}],"outcomes":[{"outcome_type":"secondary","measure":"nasal symptoms and Peak Nasal Inspiratory Flow","time_frame":"before and after scans","description":"Evaluation of nasal symptoms (runny nose, blocked nose, itchy nose and post-nasal drip) and conjunctival symptoms (lacrimation and itchy eyes) will be done with VAS scores and the Peak Nasal Inspiratory Flow (PNIF) will be measured before and after both functional MRI (fMRI) scans"},{"outcome_type":"primary","measure":"brain activation","time_frame":"5 minutes","description":"The specific aim of this study is to visualize the type and location of brain activation in healthy and allergic volunteers by a nasal provocation with histamine, using the functional MRI technology."}]}
{"nct_id":"NCT02787057","start_date":"2012-11-30","phase":"N/A","enrollment":80,"brief_title":"Vancomycin Plus Moxifloxacin Versus Vancomycin Plus Ceftazidime for the Treatment of Peritoneal Dialysis (PD)-Related Peritonitis","official_title":"Intraperitoneal (IP) Vancomycin Plus Oral Moxifloxacin Versus IP Vancomycin Plus IP Ceftazidime for the Treatment of Peritoneal Dialysis-related Peritonitis: a Pilot Randomized Controlled Study","primary_completion_date":"2016-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-04-30","last_update":"2020-03-26","description":"Intra-peritoneal administration of antibiotics covering both gram-positive and gram-negative organisms was recommended as first-line regimen for the management of peritoneal dialysis related peritonitis. Oral administration of quinolones can also achieve effective serum concentrations, and is more convenient and economical. We conducted a pilot randomized controlled study to compare the effects on peritonitis cure and relapsing rates between oral moxifloxacin plus IP vancomycin and conventional IP vancomycin plus ceftazidime.","other_id":"empirical schemes","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  incident or prevalent peritoneal dialysis patients\r\n\r\n          -  diagnosis of acute peritonitis according to ISPD guideline\r\n\r\n          -  age >18 years\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  receiving antibiotic treatment for other reasons when peritonitis occurred\r\n\r\n          -  contraindication to cephalosporin, vancomycin, or fluoroquinolones\r\n\r\n          -  concomitant exit-site or tunnel infection\r\n\r\n          -  requirement for immediate transfer to hemodialysis due to sepsis, gastrointestinal\r\n             perforation or visceral inflammation, severe bowel obstruction, or ultrafiltration\r\n             failure at the initiation of peritonitis\r\n\r\n          -  inability to tolerate oral administration due to severe gastrointestinal complication\r\n             or other reasons\r\n\r\n          -  history of psychological illness or condition which interfered with ability to\r\n             understand or comply with the requirements of the study\r\n\r\n          -  pregnant or breast-feeding\r\n      ","sponsor":"Peking University First Hospital","sponsor_type":"Other","conditions":"Peritoneal Dialysis Associated Peritonitis","interventions":[{"intervention_type":"Drug","name":"Drug: ceftazidime","description":"IP ceftazidime 1g QD"},{"intervention_type":"Drug","name":"Drug: vancomycin","description":"IP vancomycin 1g every 5 days"},{"intervention_type":"Drug","name":"Drug: moxifloxacin","description":"oral moxifloxacin 400mg QD"}],"outcomes":[{"outcome_type":"primary","measure":"Complete Cure Rate","time_frame":"within 4 weeks of completion of therapy","description":"complete cure was defined as complete resolution of peritonitis (normalization of body temperature, resolution of abdominal pain, clearing of dialysate, and PD effluent neutrophil count less than 100 cells/mL and proportion of polynuclear cell less than 50%) by using antibiotics alone without relapse within 4 weeks of completion of therapy"},{"outcome_type":"secondary","measure":"Primary Response Rate","time_frame":"on day 10 by using antibiotics alone","description":"Primary response was defined as resolution of peritonitis (normalization of body temperature, resolution of abdominal pain, clearing of dialysate, and PD effluent neutrophil count less than 100 cells/mL and proportion of polynuclear cell less than 50%) on day 10 by using antibiotics alone"},{"outcome_type":"secondary","measure":"Primary Treatment Failure Rate","time_frame":"after 3 days of treatment by the assigned antibiotics","description":"Primary treatment failure was defined as the presence of fever, abdominal pain, and turbid peritoneal dialysate, and if the total peritoneal WBC counts is >50% of the pretreatment values after 3 days of treatment by the assigned antibiotics"},{"outcome_type":"secondary","measure":"Secondary Treatment Failure Rate","time_frame":"after 6 to 8 days of treatment","description":"Secondary treatment failure was defined as treatment failure despite adjustment of antibiotics or changing to second line antibiotics for 3 to 5 days in patients with primary treatment failure"}]}
{"nct_id":"NCT01834313","start_date":"2012-11-30","enrollment":600,"brief_title":"Willingness to Pay for Patient-centred Care","official_title":"Identifying Patients' and Healht Insurers' Preferences Regarding Patient-centred Care by Determining Their Willingness-to-pay for Patient-centred Care","primary_completion_date":"2013-08-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2013-10-31","last_update":"2013-07-23","description":"The purpose of this study is to evaluate the monetary value of patient-centrednes in health care by determining a willingness-to-pay for more patient-centredness care for both patients and health insurers","other_id":"DCE","observational_model":"Cohort","time_perspective":"Cross-Sectional","sampling_method":"Probability Sample","gender":"All","population":"Patient who are under treatment for their fertility problem and underwent at least one\r\n        treatment in one of 10 Dutch clinics.\r\n\r\n        All healthcare purchasers from the 5 large Dutch health insurer companies","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients undergoing MAR-treatment (ovulation induction, intra-uterine inseminations,\r\n             in vitro fertilization, or intra-cytoplasmic sperm injection)\r\n\r\n          -  All healthcare purchasers working at one of the 5 large Dutch health insurer\r\n             companies.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  None\r\n      ","sponsor":"A.G. Huppelschoten","sponsor_type":"Other","conditions":"Willingness-to-pay|Patient-centredness","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Willingness-to-pay for patient-centred care","time_frame":"6 months","description":"A willingness-to-pay for patient-centred care for both patients and health insurers"}]}
{"nct_id":"NCT01708850","start_date":"2012-11-30","phase":"Phase 4","enrollment":70,"brief_title":"Study in Cancer Patients With Central Line Associated Clots in the Upper Extremity Treated With Rivaroxaban (Catheter 2)","official_title":"A Pilot Study in Cancer Patients With Central Venous Catheter Associated Deep Vein Thrombosis in the Upper Extremity Treated With Rivaroxaban (Catheter 2)","primary_completion_date":"2016-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-06-30","last_update":"2016-09-08","description":"Patients with cancer and an upper extremity DVT associated with a central venous catheter (CVC) will receive rivaroxaban. CVC survival will be assessed and compared to previous rates with low molecular weight heparin (LMWH) and warfarin, along with secondary safety outcomes including bleeding and recurrent venous thromboembolism. The investigators hypothesize that anticoagulation with rivaroxaban in patients with UEDVT secondary to central venous catheters in patients with active malignancy is an effective therapy as quantified by the success of catheter preservation. Prolonged line salvage rate without recurrence of UEDVT will improve the management of cancer patients who develop an upper extremity deep venous thrombosis in the setting of a central venous catheter.","other_id":"Catheter 2","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Male or female > 18 years of age.\r\n\r\n          2. Symptomatic acute upper limb thrombosis in the axillary, subclavian, innominate or\r\n             internal jugular veins, with or without pulmonary embolism, associated with central\r\n             venous catheter objectively documented by compression ultrasonography, venogram or CT\r\n             scan.\r\n\r\n          3. Diagnosis of active malignancy (other than non-melanoma skin cancer), defined as\r\n             patients who are either receiving active treatment, or have metastatic disease or who\r\n             have been diagnosed within the past two years.\r\n\r\n          4. Willing to provide written informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Dialysis catheters.\r\n\r\n          2. Active bleeding or high risk for major bleeding.\r\n\r\n          3. Platelet Count < 75 x 109/L.\r\n\r\n          4. Creatinine Clearance < 30 mL/min.\r\n\r\n          5. Currently on other anticoagulant with therapeutic intent for another indication.*\r\n\r\n          6. Pulmonary embolism accompanied by hemodynamic instability or oxygen requirement.\r\n\r\n          7. Inability to infuse through the catheter after a trial of intraluminal thrombolytic\r\n             therapy (ie. 2 mg tPA).\r\n\r\n          8. Patients with AML, ALL or multiple myeloma with a bone marrow or stem cell transplant\r\n             planned within the next 3 months.\r\n\r\n          9. Thrombosis involving the brachial or cephalic veins only.\r\n\r\n         10. Treatment for current episode > 7 days with any acceptable anticoagulant therapy.\r\n\r\n         11. Concomitant use of P-glycoprotein and CYP3A4 inhibitors (ie. azole antifungals such as\r\n             ketoconazole) or inducers (ie. rifampicin, antiepileptics).*\r\n\r\n         12. Recent coronary artery stent requiring dual anti-platelet therapy.\r\n      ","sponsor":"London Health Sciences Centre","sponsor_type":"Other","conditions":"Neoplasm|Central Venous Catheter Thrombosis","interventions":[{"intervention_type":"Drug","name":"Drug: Rivaroxaban","description":"All specified in arm description. One arm study."}],"outcomes":[{"outcome_type":"primary","measure":"Proportion of central line failure, defined as infusion failure that does not respond to 2mg tPA.","time_frame":"12 weeks","description":"The primary endpoint of the study will be proportion of central line failure, defined as infusion failure that does not respond to 2mg tPA, within the 3 months of study follow-up."},{"outcome_type":"secondary","measure":"Recurrence of DVT or PE","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"Major Bleeding","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"Clinically Relevant Non-Major Bleeding","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"Death","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"Time to Central Line Failure","time_frame":"12 weeks"}]}
{"nct_id":"NCT01725165","start_date":"2012-11-28","phase":"Phase 2","enrollment":94,"brief_title":"Surgery and/or Radiation Therapy or Standard Therapy and/or Clinical Observation in Treating Patients With Previously Treated Stage IV Non-small Cell Lung Cancer","official_title":"A Randomized Phase II Study Assessing the Efficacy of Local Consolidative Therapy for Non-Small Cell Lung Cancer Patients With Induced Oligometastatic Disease","primary_completion_date":"2021-03-24","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2021-03-24","last_update":"2020-03-26","description":"This randomized phase II trial studies how well surgery and/or radiation therapy or standard therapy and/or clinical observation works in treating patients with previously treated stage IV non-small cell lung cancer. Radiation therapy uses high energy x-rays to kill tumor cells. Giving surgery and/or radiation therapy may be more effective than standard therapy and/or clinical observation in patients with previously treated non-small cell lung cancer.","other_id":"2012-0618","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  STEP 1 ENROLLMENT: the patient has a diagnosis of pathologically confirmed NSCLC by\r\n             tumor biopsy and/or fine-needle aspiration; mixed tumors will be categorized by the\r\n             predominant cell type\r\n\r\n          -  STEP 1 ENROLLMENT: the patient has a diagnosis of American Joint Committee on Cancer\r\n             (AJCC) 7th Edition stage IV NSCLC\r\n\r\n          -  STEP 1 ENROLLMENT: three or less metastatic lesions (not sites); each lesion\r\n             (including a satellite nodule) will individually be counted as one, and intrathoracic\r\n             lymph node involvement (defined here as hilar, mediastinal, or supraclavicular nodes,\r\n             N1-N3) will collectively be counted as one; in addition, patients can receive\r\n             treatment to CNS lesions or other symptomatic lesions requiring urgent local therapy\r\n             prior to randomization, but these lesions will be counted towards the total number\r\n             after chemotherapy, and patients will only be eligible if there are remaining sites\r\n             amenable to local therapy after up-front systemic therapy\r\n\r\n          -  STEP 1 ENROLLMENT: standard induction chemotherapy planned defined as: at least 4\r\n             cycles of platinum doublet chemotherapy for metastatic disease (with or without\r\n             bevacizumab); if the patient is known to be EGFR mutation positive, erlotinib,\r\n             afatinib, or gefitinib for >= 3 months, or for patients with known EML4-ALK fusions,\r\n             crizotinib for >= 3 months\r\n\r\n          -  STEP 2 ENROLLMENT AND RANDOMIZATION: the patient has a diagnosis of pathologically\r\n             confirmed NSCLC by tumor biopsy and/or fine-needle aspiration; mixed tumors will be\r\n             categorized by the predominant cell type\r\n\r\n          -  STEP 2 ENROLLMENT AND RANDOMIZATION: the patient has a diagnosis of American Joint\r\n             Committee on Cancer (AJCC) 7th edition stage IV NSCLC\r\n\r\n          -  STEP 2 ENROLLMENT AND RANDOMIZATION: completion of standard induction chemotherapy\r\n             planned defined as: at least 4 cycles of platinum doublet chemotherapy for metastatic\r\n             disease (with or without bevacizumab); if the patient is known to be EGFR mutation\r\n             positive, erlotinib, afatinib, or gefitinib for >= 3 months, or for patients with\r\n             known EML4-ALK fusions, crizotinib; note that it is not mandatory to check EGFR\r\n             mutation or EML4-ALK status prior to entry, but patients that receive options 2 or 3\r\n             should have had these molecular tests performed\r\n\r\n          -  STEP 2 ENROLLMENT AND RANDOMIZATION: less than or equal to three metastatic lesions\r\n             and no evidence of disease progression based on RECIST criteria; note that patients\r\n             that had > 3 metastatic lesions in Step 1 may be eligible for enrollment in Step 2 if\r\n             the number of metastatic sites is reduced to three or less\r\n\r\n          -  STEP 2 ENROLLMENT AND RANDOMIZATION: the patient's Eastern Cooperative Oncology Group\r\n             (ECOG) performance status is =< 2 at study entry\r\n\r\n          -  STEP 2 ENROLLMENT AND RANDOMIZATION: absolute neutrophil count (ANC) >= 1,500/mm^3\r\n             within 3 weeks of study entry\r\n\r\n          -  STEP 2 ENROLLMENT AND RANDOMIZATION: platelet count >= 100,000/mm^3 within 3 weeks of\r\n             study entry\r\n\r\n          -  STEP 2 ENROLLMENT AND RANDOMIZATION: white blood cells (WBC) >= 3,000/mm^3 within 3\r\n             weeks of study entry\r\n\r\n          -  STEP 2 ENROLLMENT AND RANDOMIZATION: hemoglobin >= 9 g/dL within 3 weeks of study\r\n             entry\r\n\r\n          -  STEP 2 ENROLLMENT AND RANDOMIZATION: the patient must be a suitable candidate for LCT\r\n             (radiotherapy and/or surgery) to every site of disease, as determined by the treating\r\n             physician(s); consultation with a multidisciplinary team, including a medical\r\n             oncologist, radiation oncologist, and thoracic surgeon, is encouraged but not required\r\n\r\n          -  STEP 2 ENROLLMENT AND RANDOMIZATION: concurrent chemoradiation is permitted as\r\n             consolidative therapy; the following concurrent therapies are permitted: tyrosine\r\n             kinase inhibitors (i.e. erlotinib) - can be delivered with both hypofractionated (>= 3\r\n             Gray [Gy] per fraction) and standard fractionated radiation therapy (< 3 Gy per\r\n             fraction); platinum-based chemotherapy - standard fractionated radiation therapy (< 3\r\n             Gy per fraction)\r\n\r\n          -  STEP 2 ENROLLMENT AND RANDOMIZATION: bevacizumab will not be permitted within 2 weeks\r\n             of the initiation of the radiation therapy course\r\n\r\n          -  STEP 2 ENROLLMENT AND RANDOMIZATION: treatment to central nervous system lesions, such\r\n             as the brain or spine (prior to first line systemic therapy), or symptomatic lesions\r\n             requiring urgent palliative radiation, is permitted prior to randomization, in which\r\n             case the patient would be randomized to treatment of other metastatic sites or the\r\n             primary sites (based on the disease remaining after first-line treatment); these\r\n             treated lesions should be counted towards the total number of metastases at the time\r\n             of enrollment\r\n\r\n          -  STEP 2 ENROLLMENT AND RANDOMIZATION: the patient has signed informed consent\r\n\r\n          -  STEP 2 ENROLLMENT AND RANDOMIZATION: women of childbearing potential must agree to use\r\n             adequate contraception (hormonal or barrier method of birth control; abstinence) for\r\n             the duration of study participation and for six (6) months after discontinuation of\r\n             the study drugs; childbearing potential will be defined as women who have had menses\r\n             within the past 12 months, who have not had tubal ligation, hysterectomy or bilateral\r\n             oophorectomy; should a woman become pregnant or suspect that she is pregnant while\r\n             participating in this study, she should inform her treating physician immediately; the\r\n             patient, if a man, agrees to use effective contraception or abstinence for the\r\n             duration of study participation and for six (6) months after discontinuation of the\r\n             study drugs\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  STEPS 1 AND 2 AND RANDOMIZATION\r\n\r\n          -  The patient has a history of uncontrolled angina, arrhythmias, or congestive heart\r\n             failure\r\n\r\n          -  Patients with a history of malignant pleural effusions are not eligible; pleural\r\n             effusions considered by the investigator too small for a diagnostic thoracentesis are\r\n             permissible\r\n\r\n          -  Patient is pregnant (confirmed by serum beta- b-human chorionic gonadotropin [HCG] if\r\n             applicable) or is breastfeeding\r\n\r\n          -  Presence of significant third space fluid which cannot be controlled by drainage\r\n      ","sponsor":"M.D. Anderson Cancer Center","sponsor_type":"Other","conditions":"Recurrent Lung Non-Small Cell Carcinoma|Stage IV Non-Small Cell Lung Cancer AJCC v7","interventions":[{"intervention_type":"Other","name":"Other: Clinical Observation","description":"Undergo clinical observation"},{"intervention_type":"Radiation","name":"Radiation: External Beam Radiation Therapy","description":"Undergo EBRT"},{"intervention_type":"Other","name":"Other: Laboratory Biomarker Analysis","description":"Optional correlative studies"},{"intervention_type":"Other","name":"Other: Quality-of-Life Assessment","description":"Ancillary studies"},{"intervention_type":"Procedure","name":"Procedure: Standard Follow-Up Care","description":"Undergo standard maintenance therapy"},{"intervention_type":"Procedure","name":"Procedure: Therapeutic Conventional Surgery","description":"Undergo surgery"}],"outcomes":[{"outcome_type":"primary","measure":"Progression-free survival (PFS)","time_frame":"Time from randomization (immediate local consolidation therapy [LCT] vs delayed/no LCT) to disease progression or death, assessed up to 9 months","description":"Kaplan-Meier estimate will be computed and the log-rank test will be performed to compare the difference of PFS between the two arms. Cox regression model will be applied to correlate PFS with potential covariates in both the univariate and multi-covariate analyses. To account for patients that crossover for reasons other than Response Evaluation Criteria in Solid Tumors (RECIST) progression of disease, censoring will occur at the time of crossover for primary analysis."},{"outcome_type":"secondary","measure":"Incidence of toxicities","time_frame":"Up to at least 1 year (periodically thereafter)","description":"Descriptive statistics will be provided to summarize the toxicities by the treatment arms (immediate LCT and delayed/no LCT groups)."},{"outcome_type":"secondary","measure":"Overall survival","time_frame":"Up to 9 months","description":"Kaplan-Meier estimate will be used."},{"outcome_type":"secondary","measure":"Time to progression of prior metastatic lesions","time_frame":"Up to 9 months","description":"Kaplan-Meier estimate will be used."},{"outcome_type":"secondary","measure":"Time to appearance of new metastases (central nervous system [CNS] vs extra-CNS, treated lesion vs. new site)","time_frame":"Up to 9 months","description":"Kaplan-Meier estimate will be used."},{"outcome_type":"secondary","measure":"Quality of life (QOL) assessed using the Symptom Assessment (optional)","time_frame":"Up to 1 year","description":"QOL will be analyzed by the repeated measures analysis of variance to count for the change before and after treatment and during the follow-up period. Proper transformation will be performed if necessary to transform data to be closer to the Gaussian distribution."},{"outcome_type":"secondary","measure":"Impact of crossover without RECIST progression","time_frame":"Up to 9 months","description":"A time varying covariate model will be used."}]}
{"nct_id":"NCT03583723","start_date":"2012-11-02","phase":"N/A","enrollment":50,"brief_title":"Adaptive Radiotherapy in Locally Advanced Non-Small Cell Lung Cancer (LARTIA Trial)","official_title":"Adaptive Radiation Therapy in Locally Advanced Non-Small Cell Lung Cancer (LARTIA Trial)","primary_completion_date":"2017-01-10","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-01-20","last_update":"2018-07-12","description":"Anatomical change of tumor during radiotherapy contributes to target missing. However, in the case of tumor shrinkage, adaptation of volume could result in an increased incidence of recurrence in the area of target reduction. This study aims to investigate the incidence of failure of the adaptive approach in Locally Advanced Non-Small Cell Lung Cancer and, in particular, the risk for local recurrence in the area excluded after replanning.","other_id":"60/12 PAR ComEt CBM","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  histologically or cytologically proven NSCLC;\r\n\r\n          -  inoperable stage IIIA/IIIB disease and intrathoracic relapse after surgery;\r\n\r\n          -  positron emission tomography (PET)/computed tomography (CT) and/or total-body CT with\r\n             contrast excluding metastatic disease (including brain);\r\n\r\n          -  no previous radiotherapy treatment;\r\n\r\n          -  Eastern Cooperative Oncology Group performance status of 0 to 1;\r\n\r\n          -  clinically measurable/evaluable disease;\r\n\r\n          -  minimum life expectancy of 12 weeks;\r\n\r\n          -  adequate respiratory, renal, hepatic and bone marrow function and non-contraindicative\r\n             cardiovascular disease.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  previous radiotherapy treatment\r\n\r\n          -  concurrent systemic disorders incompatible with chemotherapy or radiotherapy\r\n      ","sponsor":"Campus Bio-Medico University","sponsor_type":"Other","conditions":"Non-Small Cell Lung Cancer","interventions":[{"intervention_type":"Radiation","name":"Radiation: Radiotherapy Group","description":"Patients will be immobilized with customized devices. Either four-dimensional CT or slow CT images using a multislice CT scanner will be acquired to evaluate internal target motion. Initially, gross tumor volume (GTV) will be determined in the maximum intensity projection on the initial size of the tumor and involved lymph nodal sites defined as PET-positive nodes and/or a node diameter greater than 1 cm, clinical target volume (CTV) will be defined as equal to the GTV plus node-positive stations and hilar stations, and planning target volume (PTV) will be created equal to the CTV plus a 0.5-cm safety margin. Treatment will be performed with a linear accelerator in a photon regimen, with a 6-to 15-megavolt (MV) nominal energy and three-dimensional (3D) conformal technique."}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of Local Recurrence and Pattern of Failure","time_frame":"three months","description":"Patients are not considered to have local-regional control unless they achieve at least a partial response of their primary tumor or stable disease by imaging. Patients who do not achieve objective response are considered to have local-regional failure. Local-regional control rates are analyzed using the Kaplan-Meier method. Local recurrences are defined according to a dimensional and metabolic increase at chest CT with intravenous contrast and fludeoxyglucose F 18 (FDG) PET/CT. Recurrences are identified visually and independently by three radiation oncologists with the same method. The modality for definition of failures is readjusted with these definitions: \"in-field failure\" when a dimensional and/or metabolic progression is reported within the replanning PTV; \"marginal failure\" in cases of recurrence in the initial PTV but not in the replanning PTV, and \"out-of-field failure\" if the recurrence occurs outside the initial PTV."},{"outcome_type":"secondary","measure":"Response evaluation","time_frame":"three months","description":"Response evaluation is defined according to the Response Evaluation Criteria in Solid Tumors criteria for complete and partial response, progression, and stable disease."},{"outcome_type":"secondary","measure":"Overall Survival","time_frame":"three years","description":"Overall Survival is determined from the day of the diagnosis to the death, or to the last follow-up if no event is observed"},{"outcome_type":"secondary","measure":"Progression-Free Survival","time_frame":"three years","description":"Progression-free survival is obtained from the beginning of treatment to the observation of progression/recurrence, or to the last follow-up if no event is observed."}]}
{"nct_id":"NCT01946919","start_date":"2012-10-31","enrollment":18000,"brief_title":"Post-Marketing Surveillance of the Cinepazide Maleate Injection: a Real World Study","official_title":"Post-Marketing Surveillance of the Cinepazide Maleate Injection: a Real World Study","primary_completion_date":"2014-06-30","study_type":"Observational [Patient Registry]","rec_status":"Unknown status","completion_date":"2014-06-30","last_update":"2013-12-03","description":"Cinepazide Maleate Injection is widely used in cerebrovascular disease in china. The safety of the cinepazide, especially the blood system, has not been fully evaluated in Chinese population. In order to improve the rational use of cinepazide, the investigators observe its clinical use in the real world in China, evaluate its safety and clinical benefit in a large Chinese population.","other_id":"PekingUTH-Pharmacy-002","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","population":"Inpatient using the cinepazide in the department of neurology in 61 hospitals in China.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Inpatient using the cinepazide in the department of neurology\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  none\r\n      ","sponsor":"Peking University Third Hospital","sponsor_type":"Other","conditions":"Adverse Drug Reaction|Cinepazide|Stroke","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Incidence of adverse drug reaction of cinepazide in department of neurology","time_frame":"1.5 years"},{"outcome_type":"secondary","measure":"Outcomes of the patients who experienced an adverse drug reaction of cinepazide.","time_frame":"1.5 years","description":"Outcomes including cure, improved, null, or death."},{"outcome_type":"secondary","measure":"The predictors of the adverse drug reaction of cinepazide","time_frame":"1.5 years","description":"We will analyse whether some factors, such as age, gender, medical history and etc, would be the predictors of the adverse drug reaction of cinepazide."},{"outcome_type":"secondary","measure":"Types of the adverse drug reaction of cinepazide.","time_frame":"1.5 years","description":"The types of the adverse drug reaction of cinepazide including Nausea, vomiting, itching and etc."},{"outcome_type":"secondary","measure":"The treatment when patients experienced an adverse drug reaction of cinepazide.","time_frame":"1.5 years","description":"Treatments including oxygen, steroids, and etc. According to severity of the adverse drug reactions, we will analyse the features the treatments, such as types and numbers."}]}
{"nct_id":"NCT01724593","start_date":"2012-10-31","enrollment":30,"brief_title":"Functional Recovery in Critically Ill Children","official_title":"Functional Recovery in Critically Ill Children - the Wee-Cover Pilot Study","primary_completion_date":"2013-11-30","study_type":"Observational","rec_status":"Completed","completion_date":"2013-11-30","last_update":"2013-11-05","description":"Intensive Care Unit-acquired weakness (ICU-AW) is a well-recognized, important and preventable sequelae of critical illness, affecting up to 60% of adult ICU patient. ICU-AW is associated with increased mortality and length of stay, and negatively impacts long-term functional outcomes and quality of life in affected patients and their caregivers. While delayed mobilization adversely affects clinical outcomes, early rehabilitation in the critically ill adult population is safe, feasible, cost effective, results in more ventilator free-days and better functional outcomes at hospital discharge. In contrast, there is a paucity of this research in pediatrics. Our research suggests that immobilization is common in critically ill children, and rehabilitation is delayed particularly in the sickest children who are arguably at highest risk of morbidity. It is unclear however, whether delayed rehabilitation leads to adverse outcomes in critically ill children, as has been demonstrated in adults. Our objectives of this study are to evaluate if immobilization and delayed rehabilitation negatively impacts short-term clinical outcomes and the time to functional recovery in critically ill children. The investigators hypothesize that the following factors may influence functional recovery and morbidity in critically ill children: - Pre-morbid condition - Age - Time-to-initiation of acute rehabilitation - Critical illness disease severity","other_id":"HHS REB No. 12-475","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":1,"maximum_age":17,"population":"Critically Ill Children","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age over 12 months to 17 years\r\n\r\n          -  PCCU stay of  48 hours\r\n\r\n          -  Patient is limited to bed-rest and has not been mobilized during the first 48 hours of\r\n             PCCU admission\r\n\r\n          -  Equal to or greater than one organ dysfunction on PCCU admission (as measured by\r\n             PELOD)\r\n\r\n          -  Informed consent of patient/substitute decision maker.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Age: < 12 months or 18 years\r\n\r\n          -  Patients admitted to step-down/intermediate care\r\n\r\n          -  Patients transferred from Neonatal intensive care unit and never discharge home.\r\n\r\n        iv) Patients who are already mobilizing well, or are at baseline functional status at time\r\n        of screening v) Admission diagnosis of a neuromuscular disorder: e.g. Acute Guillain-Barr\r\n        Syndrome, Botulism, Myasthenia Gravis), or acute spinal cord injury/transverse myelitis vi)\r\n        Not expected to survive PCCU/hospital stay vii) Previously enrolled into study less than 6\r\n        months ago and/or still undergoing study procedures at time of screening\r\n      ","sponsor":"Karen Choong","sponsor_type":"Other","conditions":"Critical Illness|Children","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Feasibility","time_frame":"12 months","description":"Feasibility will be determined by the consent and enrolment rate, and the protocol adherence and follow-up rates."},{"outcome_type":"secondary","measure":"Functional Recovery","time_frame":"Baseline, 3 and 6 month follow-up","description":"Functional Recovery will be measured by the following standardized, validate pediatric assessment tools of function, as defined by the International Classification of Functioning, Disability and Health (ICF): 1) Pediatric Evaluation of Disability Inventory (PEDI); 2) Participation and Environment Measure - children and youth version (PEM-CY), and preschool version; 3) Pediatric Overall Performance Category score (POPC); 4) Pediatric Cerebral Performance Category Score (PCPC)"},{"outcome_type":"secondary","measure":"Pediatric Critical care Unit (PCCU) clinical outcomes","time_frame":"at 30 days and duration of hospitalization","description":"PCCU outcomes will be assessed by the following: Ventilator-free days, PCCU mortality, length of PCCU and hospital stay, and the incidence of PCCU-acquired weakness"},{"outcome_type":"secondary","measure":"Muscle Strength","time_frame":"Hospital discharge and at 3 and 6 month follow-up","description":"In an age-appropriate subgroup, the following measurements will be conducted:\r\nMuscle Strength and aerobic fitness testing (age ≥ 5 years, and/or able to cognitively and physically comply with strength and fitness tests)\r\nMeasurement of muscle strength using BIODEX and hand grip strength, and assessment of lean mass (Bioelectrical impedance analysis)"},{"outcome_type":"secondary","measure":"Parental or caregiver stress","time_frame":"3 month follow-up","description":"Parental or caregiver stress will be measured with the Parental Stress Index (PSI)"},{"outcome_type":"other","measure":"Feasibility and reliability of screening for PCCU-acquired weakness","time_frame":"Duration of Hospitalization, 3 and 6 months follow-up","description":"The most appropriate method of screening and diagnosing PCCU-acquired weakness has not been well established given the many challenges in ascertainment in this population. Hence, one of the objectives of this study is to determine whether manual muscle strength testing is a feasible and reliable method of screening for this important disorder in the critically ill pediatric population. Muscle strength will be quantified clinically using the (MRC) score by 2 independent assessors. For a subset of age appropriate (≥ 4 years), we will determine their hand-grip strength using a hand dynamometer or Martin Vigorimeter, depending on their age."}]}
{"nct_id":"NCT01612793","start_date":"2012-10-31","enrollment":4,"brief_title":"Vagus Nerve Stimulation for Management of Bronchoconstriction in Patients Hospitalized With COPD Exacerbations","official_title":"Non-Invasive Vagus Nerve Stimulation With the AlphaCore Device for Management of Bronchoconstriction in Patients Hospitalized With COPD","primary_completion_date":"2013-04-30","study_type":"Observational","rec_status":"Terminated","completion_date":"2013-04-30","last_update":"2019-02-28","description":"This study will look at the safety, improving symptoms and decreasing the length of stay of patients admitted to the hospital with COPD.","other_id":"COPD-CA-01","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":35,"population":"Potential study subjects will be provided a study information sheet (informed consent form)\r\n        to review. Those who are interested in participating will provide signed informed consent\r\n        and then be screened for eligibility (inclusion/exclusion criteria). Subjects meeting the\r\n        inclusion/exclusion criteria will be assigned a study ID number, randomized and enrolled in\r\n        the study.","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Is over the age of 35 years\r\n\r\n          2. Has a history of COPD confirmed by physician diagnosis\r\n\r\n          3. Has been admitted to the hospital with a working diagnosis of acute exacerbation of\r\n             COPD (AECOPD) defined as at least two of the following progressive symptoms: increased\r\n             dyspnea, increased sputum volume and/or increased sputum purulence that is beyond\r\n             normal day-to-day variation\r\n\r\n          4. Has a history of incomplete airway reversibility (e.g., patient not responding\r\n             clinically to short-acting -agonists in the ED) associated with a diagnosis of COPD\r\n\r\n          5. Smoking history of at least 20 pack years\r\n\r\n          6. FEV1/FVC ratio of < 0.7 and impaired FEV1 (< 80% predicted for age, sex, race and\r\n             height)\r\n\r\n          7. Is willing to participate in a 7 days post discharge ( 2 days) in-person follow-up\r\n             visit and a telephone follow-up call 30 days ( 5 days) after hospital discharge\r\n\r\n          8. Is able to give written Informed Consent, or his/her legally authorized representative\r\n             is available to give written Informed Consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Has a confirmed history of asthma (by pulmonary functions, response to -agonists and\r\n             variable symptoms)\r\n\r\n          2. Has a history of lung cancer or Talc lung\r\n\r\n          3. Is admitted to the emergency care facility with a diagnosis of the following,\r\n             confirmed on CXR, ventilation/perfusion scanning or computerized tomography (CT):\r\n\r\n               -  Pulmonary abscess;\r\n\r\n               -  Pneumonia (e.g., fever > 38.0 C, cough and new documented infiltrate)\r\n\r\n               -  Acute pulmonary embolism\r\n\r\n               -  Large pleural effusion and/or requiring thoracentesis; or\r\n\r\n               -  Pneumothorax\r\n\r\n          4. Is admitted to the emergency care facility with a working diagnosis of:\r\n\r\n               -  Acute coronary syndrome\r\n\r\n               -  Severe carotid artery disease (e.g., history of bruits, transient ischemic attack\r\n                  (TIA) or cerebrovascular accident (CVA); or\r\n\r\n               -  Stage IV heart failure according to the NYHA classification\r\n\r\n          5. Is admitted to the emergency care facility and/or hospital with a working diagnosis\r\n             of:\r\n\r\n               -  Cystic Fibrosis; or\r\n\r\n               -  Tuberculosis\r\n\r\n               -  Pneumocystis carinii pneumonia (PCP) infection in the setting of HIV\r\n\r\n          6. Other severe cardiovascular acute diseases (such as uncontrolled hypertension, recent\r\n             onset rapid atrial fibrillation and severe ventricular arrhythmias)\r\n\r\n          7. Is at risk of imminent respiratory collapse:\r\n\r\n               -  Lung Function: FEV1 < 25%\r\n\r\n               -  Rapid deterioration in respiratory status (sudden change in respiratory rate,\r\n                  decrease in oxygen saturation, change in consciousness, etc).\r\n\r\n          8. Has a condition in which collecting blood would be contraindicated or blood samples\r\n             are unable to be obtained;\r\n\r\n          9. Has an abscess or other infection, lesion (including lymphadenopathy), surgical scar,\r\n             congenital changes or broken skin at the treatment site on the neck;\r\n\r\n         10. Has confirmed severe sepsis or septic shock\r\n\r\n         11. Has a fever > 38.0 C\r\n\r\n         12. Has clinically significant changes in blood pressure or is receiving vasopressors to\r\n             maintain blood pressure\r\n\r\n         13. Has an implanted electrical and/or neurostimulator device, including but not limited\r\n             to cardiac pacemaker, automated implantable cardioverter defibrillators (AICD), vagal\r\n             neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or\r\n             cochlear implant\r\n\r\n         14. Has a history of carotid endarterectomy or vascular neck surgery on the right side\r\n\r\n         15. Has implanted metal cervical spine hardware\r\n\r\n         16. Has a condition that would interfere with completing the self-assessment\r\n             questionnaires\r\n\r\n         17. Is pregnant or breast feeding\r\n\r\n         18. Is participating in any other therapeutic clinical investigation or has participated\r\n             in a clinical trial in the preceding 30 days\r\n\r\n         19. Belongs to a population or has any condition such that the investigator believes his\r\n             or her ability to provide informed consent, comply with follow-up requirements or\r\n             provide self-assessments is compromised (e.g., homeless, developmentally disabled,\r\n             prisoner)\r\n      ","sponsor":"ElectroCore INC","sponsor_type":"Industry","conditions":"Chronic Obstructive Pulmonary Disease","interventions":[{"intervention_type":"Device","name":"Device: AlphaCore Device","description":"multiple stimulation treatments per day for duration of hospitalization"}],"outcomes":[{"outcome_type":"primary","measure":"Change in the Length of Stay in the Hospital","time_frame":"Admission to hospital, 1 week in-person visit and a 30 day phone call follow-up visit from time of discharge from the hosptal","description":"The primary outcome measure was hospital length of stay (LOS) defined as the number of days from hospital admission to the date the subject met the medical elements of the GOLD Discharge Criteria. (Global Initiative for Chronic Obstructive Lung Disease report, \"Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease\", Revised 2011)"}]}
{"nct_id":"NCT01742637","start_date":"2012-10-31","phase":"Phase 1","enrollment":2008,"brief_title":"Study Comparing Adapalene and Benzoyl Peroxide Gel 0.1%/2.5% to Epiduo and Both to a Placebo Control in the Treatment of Acne Vulgaris","official_title":"A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study Comparing Adapalene and Benzoyl Peroxide Gel 0.1%/2.5% (Taro Pharmaceuticals Inc.) to Epiduo (Galderma Laboratories, L.P., Adapalene and Benzoyl Peroxide Gel 0.1%/2.5%) and Both Active Treatments to a Placebo in the Treatment of Acne Vulgaris.","primary_completion_date":"2014-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-03-31","last_update":"2017-05-04","description":"The objective of this study is to evaluate the therapeutic equivalence and safety of Adapalene and Benzoyl Peroxide 0.1%/2.5% Gel (Taro Pharmaceuticals Inc.) and Epiduo (Adapalene and Benzoyl Peroxide 0.1%/2.5% Gel) (Galderma Laboratories, L.P.) in the treatment of acne vulgaris, and to demonstrate the superiority of the efficacy of the test and reference products over the vehicle (placebo) control in the treatment of acne vulgaris.","other_id":"ADBG-1206, 1302","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":12,"maximum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy male or non pregnant female aged  12 and  40 years with a clinical diagnosis\r\n             of acne vulgaris.\r\n\r\n          -  Subjects who are 18 years of age or older must have provided written informed consent.\r\n             Subjects 12 to 17 years of age must have provided written assent, which must be\r\n             accompanied by written informed consent from the subject's legally acceptable\r\n             representative. All subjects or their legally acceptable representatives must sign a\r\n             Health Insurance Portability and Accountability Act authorization.\r\n\r\n          -  Subjects must have a minimum of  25 non-inflammatory lesions and  20 inflammatory\r\n             lesions and  2 nodulocystic lesions, at baseline on the face.\r\n\r\n          -  Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3,\r\n             or 4 as per the Investigator's Global Assessment (IGA).\r\n\r\n          -  Subjects must be willing to refrain from using all other topical acne medications or\r\n             antibiotics for acne vulgaris during the 12-week treatment period, other than the\r\n             investigational product.\r\n\r\n          -  Female subjects of childbearing potential (excluding those who are surgically\r\n             sterilized or postmenopausal for at least 1 year), in addition to having a negative\r\n             urine pregnancy test, must be willing to use an acceptable form of birth control\r\n             during the study from the day of the first dose administration to 30 days after the\r\n             last administration of study drug.\r\n\r\n          -  All male subjects must agree to use accepted methods of birth control with their\r\n             partners, from the day of the first dose administration to 30 days after the last\r\n             administration of study drug.\r\n\r\n          -  Subjects must be willing and able to understand and comply with the requirements of\r\n             the protocol.\r\n\r\n          -  Subjects must be in good health and free from any clinically significant disease,\r\n             including but not limited to, conditions that may interfere with the evaluation of\r\n             acne vulgaris.\r\n\r\n          -  Subjects who use make-up must have used the same brands/types for a minimum period of\r\n             14 days prior to study entry and must agree to not change brand/type or frequency of\r\n             use throughout the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Female subjects who are pregnant, nursing or planning to become pregnant during study\r\n             participation.\r\n\r\n          -  Subjects with a history of hypersensitivity or allergy to adapalene, retinoids and/or\r\n             any of the study medication ingredients, have a known hypersensitivity to adapalene\r\n             and benzoyl peroxide and its excipients.\r\n\r\n          -  Subjects with the presence of any skin condition that would interfere with the\r\n             diagnosis or assessment of acne vulgaris.\r\n\r\n          -  Subjects with excessive facial hair that would interfere with diagnosis or assessment\r\n             of acne vulgaris.\r\n\r\n          -  Subjects who have performed wax depilation of the face within 14 days prior to\r\n             baseline.\r\n\r\n          -  Subjects who have used within 6 months prior to baseline or use during the study of\r\n             oral retinoids or therapeutic Vitamin A supplements of greater than 10,000 units/day.\r\n\r\n          -  Subjects who have used estrogens or oral contraceptives for less than 3 months prior\r\n             to baseline.\r\n\r\n          -  Subjects who have used any of the following procedures on the face within 1 month\r\n             prior to baseline or use during the study: cryodestruction or chemodestruction,\r\n             dermabrasion, photodynamic therapy, acne surgery, intralesional steroids, x-ray\r\n             therapy.\r\n\r\n          -  Subjects who have used any of the following treatments within 1 month prior to\r\n             baseline or use during the study: systemic steroids, systemic antibiotics, systemic\r\n             treatment for acne vulgaris, systemic anti-inflammatory agents.\r\n\r\n          -  Subjects who have used any of the following treatments within 2 weeks prior to\r\n             baseline or during the study: topical steroids, topical retinoids, -hydroxy/glycolic\r\n             acid, benzoyl peroxide, topical anti-inflammatory agents, topical antibiotics.\r\n\r\n          -  Use of spironolactone is prohibited during the study.\r\n\r\n          -  Use of tanning booths, sunbathing, or excessive exposure to the sun are prohibited\r\n             during the study.\r\n\r\n          -  Subjects who have received radiation therapy and/or anti-neoplastic agents within 90\r\n             days prior to baseline.\r\n\r\n          -  Subjects who have unstable medical disorders that are clinically significant or have\r\n             life-threatening diseases.\r\n\r\n          -  Subjects who have on-going malignancies requiring systemic treatment, and subjects who\r\n             have any malignancy of the skin of the facial area.\r\n\r\n          -  Subjects who engage in activities that involve excessive or prolonged exposure to\r\n             sunlight or weather extremes, such as wind or cold.\r\n\r\n          -  Subjects who consume excessive amounts of alcohol or use drugs of abuse.\r\n\r\n          -  Subjects who have participated in an investigational drug study within 30 days prior\r\n             to baseline.\r\n\r\n          -  Subjects who have been previously enrolled in this study.\r\n\r\n          -  Subjects who have had laser therapy, electrodesiccation and phototherapy to the facial\r\n             area within 180 days prior to study entry.\r\n\r\n          -  Subjects who have had cosmetic procedures which may affect the efficacy and safety\r\n             profile of the investigational product within 14 days prior to study entry. Cosmetic\r\n             procedures and facials are prohibited throughout the study.\r\n\r\n          -  Subjects who currently have or have recently had bacterial folliculitis on the face.\r\n      ","sponsor":"Taro Pharmaceuticals USA","sponsor_type":"Industry","conditions":"Acne Vulgaris","interventions":[{"intervention_type":"Drug","name":"Drug: Adapalene and Benzoyl Peroxide Gel 0.1%/2.5%","description":"Adapalene and Benzoyl Peroxide Gel 0.1%/2.5% (Taro Pharmaceuticals Inc.)applied topically once daily for 84 consecutive days."},{"intervention_type":"Drug","name":"Drug: Epiduo Gel","description":"Epiduo (Adapalene and Benzoyl Peroxide Gel 0.1%/2.5%) (Galderma Laboratories, L.P.)applied topically once daily for 84 consecutive days."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo (vehicle of test product) (Taro Pharmaceuticals Inc.)applied topically once daily for 84 consecutive days."}],"outcomes":[{"outcome_type":"primary","measure":"Inflammatory and non-inflammatory lesion counts","time_frame":"Week 12","description":"Percent change from baseline to week 12 in the inflammatory (papules and pustules) and non-inflammatory (open and closed comedones) lesion counts."},{"outcome_type":"secondary","measure":"Clinical response of success.","time_frame":"Week 12","description":"The proportion of subjects with a clinical response (IGA) of success at week 12. Success should be defined as an IGA score that is at least 2 grades less than the baseline assessment."}]}
{"nct_id":"NCT01670019","start_date":"2012-10-31","phase":"Phase 4","enrollment":46,"brief_title":"Antidepressant Plus Asenapine Versus Antidepressant Plus Placebo for Depression","official_title":"A Randomized, Blinded, Comparison of Asenapine and Placebo as Adjunctive Treatment in Patients With Non-Psychotic Major Depressive Disorder Incompletely Responsive to Antidepressant Monotherapy","primary_completion_date":"2014-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-06-30","last_update":"2015-10-01","description":"This is a 6-week comparison of asenapine versus placebo as an add-on to ongoing antidepressant treatment in patients with major depression who have not had a complete therapeutic response to treatment with the antidepressant alone. The investigators hypothesize that added asenapine will produce greater reductions in depression than will added placebo.","other_id":"Pro00037462","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        -130 male or female patients, 18-65 years of age, with:\r\n\r\n          1. DSM-IV diagnosis of MDD without psychosis (single episode or recurrent) confirmed by\r\n             the Mini-International Neuro-psychiatric Interview (MINI)\r\n\r\n          2. MADRS total score > 20, and item 1 (Apparent Sadness) score > 2 at enrollment and\r\n             randomization\r\n\r\n          3. Inadequate therapeutic response during their current depressive episode; an inadequate\r\n             therapeutic response will be defined as continued depressive psychopathology (see\r\n             criterion 2) following > six weeks of therapy at adequate doses (according to the US\r\n             label) of any non-tricyclic, non-MAOI antidepressant medication\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Additional DSM-IV Axis I diagnoses other than Generalized Anxiety Disorder, Panic\r\n             Disorder with or without Agoraphobia, or Social Phobia within 6 months prior to\r\n             enrollment\r\n\r\n          2. DSM-IV Axis II diagnoses that significantly impact the current psychiatric status\r\n\r\n          3. Current MDD episode lasting > 12 months\r\n\r\n          4. Electroconvulsive therapy within the preceding 6 months\r\n\r\n          5. Substance or alcohol dependence, as defined by DSM-IV criteria, within 6 months prior\r\n             to enrollment\r\n\r\n          6. Unstable medical illness, epilepsy, traumatic brain injury, Parkinson disease, or\r\n             dementia (MMSE <24)\r\n\r\n          7. Risk of suicide as defined by MADRS item 10 score > 4\r\n\r\n          8. Prior failure to respond to asenapine\r\n\r\n          9. Pregnancy or failure to use an acceptable form of birth control. Pregnancy as\r\n             determined by serum pregnancy test at baseline\r\n\r\n         10. Hepatic impairment and history of low WBC, by medical history and interview.\r\n      ","sponsor":"Duke University","sponsor_type":"Other","conditions":"Major Depressive Disorder Without Psychotic Features","interventions":[{"intervention_type":"Drug","name":"Drug: Asenapine 5-20 mg daily","description":"5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID"},{"intervention_type":"Drug","name":"Drug: Placebo 1-4 tablets daily","description":"One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID"}],"outcomes":[{"outcome_type":"primary","measure":"Change in MADRS Total Score","time_frame":"Baseline, 6 weeks","description":"The Montgomery Asberg Depression Rating Scale (MADRS) is used by clinicians to assess the severity of depression among patients with a diagnosis of depression. It is designed to be sensitive to change resulting from antidepressant therapy.\r\nMADRS is a 10-item scale. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms."},{"outcome_type":"secondary","measure":"Study Completion Rate","time_frame":"6 weeks","description":"The percentage of patients completing the study in their assigned treatment arm (asenapine or placebo) at the end of 6 weeks"},{"outcome_type":"secondary","measure":"Clinical Response Rate","time_frame":"Baseline, 6 weeks","description":"Clinical Response rate will be defined as the number of participants with a > 50% reduction from baseline in MADRS total score.\r\nMADRS is a 10-item scale. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms."},{"outcome_type":"secondary","measure":"Clinical Remission Rate","time_frame":"6 weeks","description":"Clinical Remission will be defined as the number of participants with a MADRS total score < 7.\r\nMADRS is a 10-item scale. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms."},{"outcome_type":"secondary","measure":"Rates of Sustained Remission","time_frame":"2, 4, 6 weeks","description":"Sustained remission will be defined as at least two consecutive post-randomization assessments (weeks 2, 4, and 6) during which minimal depressive psychopathology (MADRS < 7) is present.\r\nMADRS is a 10-item scale. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms."}]}
{"nct_id":"NCT01706497","start_date":"2012-10-31","enrollment":300,"brief_title":"Predictive Value of the FORE-SIGHT Monitor for Hemodynamic Deterioration","official_title":"Validation of the Predictive Value of the FORE-SIGHT Monitor for Early Detection of Hemodynamic Deterioration After Pediatric Cardiac Surgery. A Data-mining Study.","primary_completion_date":"2016-01-31","study_type":"Observational","rec_status":"Completed","completion_date":"2016-01-31","last_update":"2019-05-15","description":"The postoperative period after congenital heart surgery in children can be a very critical episode, where it is of utmost importance to closely monitor the circulation in these patients. Invasive hemodynamic monitoring tools available in the adult population, are often not suitable to use in small children. The Fore-Sight(TM) is a non-invasive monitor for brain tissue oxygenation (SctO2), by projecting harmless near-infrared light trough the skin, skull, and brain via a disposable sensor that is applied on the forehead of patients. In many centres, the Fore-Sight (TM) is part of the routine monitoring of children during cardio-pulmonary bypass for congenital heart surgery. Although the monitor has not been tested for this purpose, it is often continued in the postoperative phase in the intensive care unit (ICU), where it is used to monitor the hemodynamic situation of the patient. The purpose of the present study is to examine and validate the use of the Fore-Sight monitor for hemodynamic monitoring of children in the postoperative phase after cardiac surgery. The study hypothesis is whether SctO2 desaturations are predictive for future hemodynamic deterioration of the patient, and whether these SctO2 desaturations are predictive for the outcome of these patients.","other_id":"KUL-S54474","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","maximum_age":12,"population":"All children younger than 12 years, admitted after cardiac surgery in the pediatric\r\n        intensive care unit (PICU) of the university hospitals Leuven, Belgium, on mechanical\r\n        ventilation or intubated after admission. Children are monitored with the FORE-SIGHT, from\r\n        admission until they are weaned off mechanical ventilation (typically, most of these\r\n        patients are mechanically ventilated between 12 hours and two weeks after ICU admission).","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  younger than 12 years of age\r\n\r\n          -  Mechanically ventilated upon ICU admission or intubated after admission\r\n\r\n          -  arterial line in place\r\n\r\n          -  expected to stay at least 24 hous in the PICU\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  actual or potential brain damage (such as traumatic brain injury, brain tumors, or\r\n             patients after cardiopulmonary resuscitation (CPR), ...).\r\n\r\n          -  patients with a condition or a wound that prohibits the placement of a forehead sensor\r\n             are also excluded.\r\n      ","sponsor":"KU Leuven","sponsor_type":"Other","conditions":"Pediatric Congenital Heart Surgery","interventions":[{"intervention_type":"Device","name":"Device: Cerebral tissue oxygen saturation monitoring, blinded"}],"outcomes":[{"outcome_type":"primary","measure":"The Accuracy to Predict Acute Kidney Injury (AKI) Per Patient, 6 Hours Before This Clinical Event (AKI) Occurs","time_frame":"Predictive window of 6 hours before AKI occurence","description":"Defined according to the Kidney Disease: Improving Global Outcome criteria (AKI stage 2 or 3)\r\nserum creatinine (SCr) level ≥ 2 times the baseline level, or\r\nurine output (UO) < 0.5 ml/kg/hour for ≥ 12 hours, or\r\nprovision of dialysis"},{"outcome_type":"secondary","measure":"Hospital Length of Stay","time_frame":"Hospital discharge","description":"participants will be followed for the duration of hospital stay, an expected average of 1-2 weeks"},{"outcome_type":"secondary","measure":"Intensive Care Unit Length of Stay","time_frame":"Intensive care unit discharge","description":"participants will be followed for the duration of hospital stay, an expected average of 1-2 weeks"},{"outcome_type":"secondary","measure":"Duration of Mechanical Ventilation","time_frame":"ICU discharge","description":"participants will be followed for the duration of hospital stay, an expected average of 1-2 weeks"},{"outcome_type":"secondary","measure":"Hospital Mortality","time_frame":"Hospital discharge","description":"participants will be followed for the duration of hospital stay, an expected average of 1-2 weeks"}]}
{"nct_id":"NCT01710748","start_date":"2012-10-31","phase":"Phase 3","enrollment":112,"brief_title":"Reservoir-Based Polymer-Free Amphilimus-Eluting Stent Versus Polymer-Based Everolimus-Eluting Stent in Diabetic Patients","official_title":"Reservoir-Based Polymer-Free Amphilimus-Eluting Stent Versus Polymer-Based Everolimus-Eluting Stent in Diabetic Patients (RESERVOIR) Trial","primary_completion_date":"2014-07-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2014-10-31","last_update":"2013-11-06","description":"This study is a prospective, randomized controlled, single blind, two-arm, multicenter clinical evaluation. Diabetic patients (n=112) with de novo coronary artery disease will be randomized to one of the 2 treatment arms: 1) Reservoir-Based Polymer-Free Amphilimus-Eluting Stent or 2) Polymer-Based Everolimus-Eluting Stent. The purpose of this study is to determine whether Polymer-Free Amphilimus-Eluting Stent implantation is effective in reducing neointimal hyperplasia as compared to Polymer-Based Everolimus-Eluting Stent in diabetic patients, using Optical Coherence Tomography (OCT) as the primary imaging modality.","other_id":"SEC-RES-2012-01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Clinical Inclusion Criteria:\r\n\r\n          -  Subject is eligible for PCI.\r\n\r\n          -  Subject has symptomatic coronary artery disease (stable/unstable angina or Non-ST\r\n             elevation myocardial infarction).\r\n\r\n          -  Subject has known DM.\r\n\r\n        Angiographic Inclusion Criteria:\r\n\r\n          -  Presence of 1 or 2 de novo native coronary artery lesions (maximum 1 lesion per\r\n             epicardial coronary artery), with a visual estimation stenosis  50%.\r\n\r\n          -  Target lesion length 12-25mm, reference diameter 2.5-3.5mm.\r\n\r\n        Clinical Exclusion Criteria:\r\n\r\n          -  ST-segment elevation myocardial infarction <48h\r\n\r\n          -  Presence of cardiogenic shock pre-procedure\r\n\r\n          -  Contra-indications to dual antiplatelet therapy for 12 months\r\n\r\n          -  Left Ventricular Ejection Fraction 30%\r\n\r\n          -  GFR<30 ml/min/m2\r\n\r\n          -  Target vessel has been treated previously\r\n\r\n          -  Platelet count <75000/mm3 or >700000/mm3\r\n\r\n          -  Immunosuppressive therapy\r\n\r\n          -  Has received or waiting list for any transplant\r\n\r\n          -  Life-threatening disease with a life expectancy of < 12 months\r\n\r\n          -  Pregnant or breast feeding patient\r\n\r\n          -  Inability to provide informed consent\r\n\r\n        Angiographic Exclusion Criteria:\r\n\r\n          -  TIMI flow  1 prior to guide wire crossing\r\n\r\n          -  There is an additional lesion within the target vessel planned to be treated within\r\n             the next 12 months\r\n\r\n          -  Target vessel is a saphenous vein graft\r\n\r\n          -  Target vessel is the left main, ostial LAD and/or ostial LCX.\r\n\r\n          -  Prior PCI of the target lesion (restenosis)\r\n\r\n          -  Lesion cannot be covered by a single stent (unplanned bailout stenting is allowed)\r\n\r\n          -  Involved side branch 2.5mm by visual estimation\r\n\r\n          -  Rotablator, ELCA or brachytherapy\r\n\r\n          -  Severe calcification of target lesion\r\n      ","sponsor":"Spanish Society of Cardiology","sponsor_type":"Other","conditions":"Coronary Artery Disease|Diabetes Mellitus","interventions":[{"intervention_type":"Device","name":"Device: Polymer-Based Everolimus-Eluting Stent","description":"Polymer-Based Everolimus-Eluting Stent"},{"intervention_type":"Device","name":"Device: Polymer-Free Amphilimus-Eluting Stent","description":"Reservoir-Based Polymer-Free Amphilimus-Eluting Stent"}],"outcomes":[{"outcome_type":"primary","measure":"Neointimal hyperplasia volume obstruction","time_frame":"9 months","description":"The primary endpoint is assessed by Optical Coherence Tomography. It is defined as neointimal hyperplasia volume (mm3) divided by the stent volume multiplied by 100."},{"outcome_type":"secondary","measure":"Percentage of uncovered struts","time_frame":"9 months","description":"This endpoint is assessed by Optical Coherence Tomography. Struts are classified as uncovered if any part of the strut is visibly exposed to the lumen, or covered if a layer of tissue is visible over all the reflecting surfaces."},{"outcome_type":"secondary","measure":"Percentage of malapposed struts","time_frame":"9 months","description":"This endpoint is assessed by Optical Coherence Tomography. Apposition is assessed strut by strut by measuring the distance between the strut marker and the lumen contour. Struts with distance to lumen contour larger than the sum of strut + polymer thickness are considered malapposed. This results in incomplete strut apposition thresholds of 89 µm for the Xience Prime and 80 µm for the Cre8 stent. Struts located at the ostium of side branches, with no vessel wall behind, are excluded from the analysis of apposition."},{"outcome_type":"secondary","measure":"Maximum percentage of NIH cross-sectional obstruction","time_frame":"9 months","description":"This endpoint is assessed by Optical Coherence Tomography. Percentage of NIH cross-sectional obstruction is defined as the NIH area (mm2) divided by the stent area multiplied by 100."},{"outcome_type":"secondary","measure":"Cardiac death","time_frame":"12 months","description":"Death related to cardiac causes; if the cause of death cannot be determined, it will be also categorized as cardiac."},{"outcome_type":"secondary","measure":"Probable or definite stent thrombosis","time_frame":"12 months","description":"Stent thrombosis is considered according to the Academic Research Consortium definitions"},{"outcome_type":"secondary","measure":"Target vessel failure","time_frame":"12 months","description":"Target vessel failure is defined as a composite endpoint of cardiac death, target vessel myocardial infarction and clinically indicated revascularization of the target vessel."}]}
{"nct_id":"NCT01635751","start_date":"2012-10-31","phase":"Phase 1","enrollment":30,"brief_title":"A Clinical Trial to Compare The Pharmacokinetics of A Pregabalin GLARS Tablet 150mg With Immediate Release Formulation and to Assess The Effect of High Fat Diet in Healthy Male Subjects","official_title":"A Randomized, Open-label, 3-way Crossover Clinical Trial to Compare The Pharmacokinetics of A Pregabalin GLARS Tablet 150mg With Immediate Release Formulation and to Assess The Effect of High Fat Diet in Healthy Male Subjects","primary_completion_date":"2012-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-11-30","last_update":"2013-01-28","description":"The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GLA5PR GLARS tablet 150mg and Lyrica Capsule 75mg. GLA5PR GLARS tablet 150mg is a new once-a-day formulation which is made by GL Pharm Tech corporation. GLARS(Geometrically Long Absorption Regulated System) is new solution to sustained absorption by extending the absorption Site. To overcome the shortcomings of the currently existing sustained release drug delivery technologies the investigators have recently developed a novel drug delivery system to enable a drug to be dissolved irrespective of the surrounding environment and further absorbed up to colon. The investigators coined this \"Geometrically Long Absorption Regulated System(GLARS)\".","other_id":"GLA5PR-101","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":20,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  20~45 years old, Healthy Adult Male Subject\r\n\r\n          -   50kg(Body Weight) and Ideal Body Weight  20%\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  ALT or AST > 1.25(Upper Normal Range)\r\n\r\n          -  Total Bilirubin > 1.5 (Upper Normal Range)\r\n      ","sponsor":"GL Pharm Tech Corporation","sponsor_type":"Industry","conditions":"Healthy","interventions":[{"intervention_type":"Drug","name":"Drug: Pregabalin","description":"GLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, fasted)"},{"intervention_type":"Drug","name":"Drug: Pregabalin","description":"GLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, after high fat meal)"},{"intervention_type":"Drug","name":"Drug: Pregabalin","description":"Lyrica Capsule 150mg/day(Pregabalin 75mg twice a day, fasted)"}],"outcomes":[{"outcome_type":"primary","measure":"Cmax","time_frame":"36hrs","description":"Pharmacokinetic of Pregabalin"},{"outcome_type":"primary","measure":"Tmax","time_frame":"36hrs","description":"Pharmacokinetic of Pregabalin"},{"outcome_type":"primary","measure":"AUC0-36h","time_frame":"36hrs","description":"Pharmacokinetic of Pregabalin"},{"outcome_type":"primary","measure":"AUC0-∞","time_frame":"36hrs","description":"Pharmacokinetic of Pregabalin"},{"outcome_type":"primary","measure":"CL/F","time_frame":"36hrs","description":"Pharmacokinetic of Pregabalin"},{"outcome_type":"primary","measure":"Vd/F","time_frame":"36hrs","description":"Pharmacokinetic of Pregabalin"},{"outcome_type":"primary","measure":"T1/2","time_frame":"36hrs","description":"Pharmacokinetic of Pregabalin"},{"outcome_type":"secondary","measure":"Safety Monitoring","time_frame":"23 days","description":"Adverse Event, Vital sign, 12-lead ECG, Laboratory test"}]}
{"nct_id":"NCT01716858","start_date":"2012-10-31","phase":"Phase 2","enrollment":10,"brief_title":"An Open Study of Sulforaphane-rich Broccoli Sprout Extract in Patients With Schizophrenia","official_title":"Sulforaphane-rich Broccoli Sprout Extract for Schizophrenia","primary_completion_date":"2013-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-03-31","last_update":"2015-07-30","description":"Accumulating evidence suggests a role of oxidative stress in the pathophysiology of schizophrenia. The potent antioxidant sulforaphane (SFN) is an organosulfur compound derived from a glucosinolate precursor found in cruciferous vegetables such as broccoli, Brussels sprouts and cabbage. The protection afforded by SFN is thought to be mediated via activation of the NF-E2-related factor-2 (Nrf2) pathway and subsequent up-regulation of phase II detoxification enzymes and antioxidant proteins, through an enhancer sequence referred to as the electrophilic responsive element or antioxidant responsive element. Recently, we reported that SFN could attenuate behavioral abnormalities in mice after the NMDA receptor antagonist phencyclidine. Considering the potent antioxidant effects of SFN, we have a hypothesis that SFN would be a potential therapeutic drug for schizophrenia. The purpose of this study is to determine whether SFN-rich broccoli sprout extract have beneficial effects in patients with schizophrenia.","other_id":"Chiba_SFN_Openstudy2012","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Schizophrenia for DSM-IV TR criteria\r\n\r\n          -  Patients are treated with an antipsychotic drug (risperidone, olanzapine, quetiapine,\r\n             perospirone, aripiprazole, blonanserin, paliperidone).\r\n\r\n          -  Patients are stable for 4-weeks for antipsychotic medication.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients treated with clozapine\r\n\r\n          -  Patients treated with two or more antipsychotic drugs\r\n\r\n          -  Pregnant or breast-feeding women\r\n\r\n          -  Patients treated with sulforaphane for more than 8-weeks in the past.\r\n      ","sponsor":"Chiba University","sponsor_type":"Other","conditions":"Schizophrenia","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Sulforaphane-rich Broccoli Sprout Extract"}],"outcomes":[{"outcome_type":"primary","measure":"Positive and Negative Syndrome Scale (PANSS)","time_frame":"Change from baseline in PANSS scores at 8-weeks"},{"outcome_type":"secondary","measure":"Cognition using CogState Research Battery","time_frame":"Change from baseline in the scores of the battery at 8-weeks"}]}
{"nct_id":"NCT01900964","start_date":"2012-10-31","phase":"N/A","enrollment":30,"brief_title":"Ridge Preservation Comparing a PTFE Nonresorbable Membrane to a Collagen Membrane","official_title":"Ridge Preservation Comparing the Clinical and Histologic Healing of a PTFE Non-resorbable vs. a Collagen Membrane With an Intrasocket Mineralized Cancellous Allograft Plus a Facial Overlay Bovine Xenograft.","primary_completion_date":"2013-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-11-30","last_update":"2016-12-08","description":"A non-resorbable PTFE (teflon) membrane will be compared to a resorbable collagen membrane when used for a post-extraction ridge preservation procedure to prevent the bone loss that typically occurs. The hypothesis is that there will be no difference in the clinical and histologic results between the two membranes.","other_id":"12.0455","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Have one non-molar tooth requiring extraction that will be replaced by a dental\r\n             implant. The site must be bordered by at least one tooth.\r\n\r\n          2. Healthy male or female who is at least 18 years old.\r\n\r\n          3. Patients must sign an informed consent approved by the University of Louisville Human\r\n             Studies Committee.\r\n\r\n             -\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients with debilitating systemic diseases, or diseases that have a clinically\r\n             significant effect on the periodontium.\r\n\r\n          2. Presence or history of osteonecrosis of jaws.\r\n\r\n          3. Patients who are currently taking IV bisphosphonates or who had IV treatment with\r\n             bisphosphonates irrespective of duration.\r\n\r\n          4. Patients who have been treated with oral bisphosphonates for more than three years.\r\n\r\n          5. Patients with an allergy to any material or medication used in the study.\r\n\r\n          6. Patients who need prophylactic antibiotics.\r\n\r\n          7. Previous head and neck radiation therapy.\r\n\r\n          8. Chemotherapy in the previous 12 months.\r\n\r\n          9. Patients on long term NSAID (nonsteroidal anti-inflammatory drug) or steroid therapy.\r\n\r\n         10. Pregnant patients. -\r\n      ","sponsor":"University of Louisville","sponsor_type":"Other","conditions":"Clinical Efficacy","interventions":[{"intervention_type":"Procedure","name":"Procedure: PTFE membrane","description":"The non-resorbable PTFE barrier membrane will be surgically placed in conjunction with a ridge preservation procedure."},{"intervention_type":"Procedure","name":"Procedure: Collagen membrane","description":"A resorbable collagen membrane is surgically placed in conjunction with a ridge preservation procedure."}],"outcomes":[{"outcome_type":"primary","measure":"Crestal ridge width","time_frame":"Time 4 months","description":"The crestal ridge width will be measured with a digital caliper at the baseline exam and at the 4 month examination."},{"outcome_type":"secondary","measure":"Percent vital bone","time_frame":"Time 4 months","description":"A trephine core will be taken at 4 months immediately prior to implant placement from the implant osteotomy site."}]}
{"nct_id":"NCT02575963","start_date":"2012-10-31","phase":"Phase 1/Phase 2","enrollment":72,"brief_title":"Lintuzumab-Ac225 in Older Acute Myeloid Leukemia (AML) Patients","official_title":"A Phase I/II Study of Lintuzumab-Ac225 in Older Patients With Untreated Acute Myeloid Leukemia","primary_completion_date":"2020-12-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2021-03-31","last_update":"2020-11-20","description":"The study is a multicenter, open label Phase I/II trial. 1. Establish the MTD of fractionated doses of Lintuzumab-Ac225 in combination with low dose cytosine arabinoside (Low Dose Ara-C, LDAC) (Phase 1 portion) 2. Determine the response rate (CR + CRp + CRi) to fractionated doses of Lintuzumab-Ac225 alone (Phase 2 portion)","other_id":"API-01","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":60,"population":"","criteria":"\n        Phase 1 Major Inclusion Criteria:\r\n\r\n          1. Untreated AML, including patients with an antecedent hematologic disorder or secondary\r\n             disease. Patients with prior MDS may have received therapy with immunomodulatory\r\n             agents or hypomethylating agents for this diagnosis. Patients with other prior cancer\r\n             diagnoses are allowed as long as they have no measurable disease, are not undergoing\r\n             active therapy, and have a life expectancy of  4 months.\r\n\r\n          2. Patients age 60 years who:\r\n\r\n               1. Are unwilling to receive intensive (e.g. 7+3) chemotherapy, or\r\n\r\n               2. Have poor-risk prognostic factors defined as antecedent hematologic disorder,\r\n                  prior chemotherapy or XRT, abnormal karyotype other than t(8;21), inv16, or\r\n                  t(16;16), any karyotype with FLT3-ITD, or presenting WBC>100K, or\r\n\r\n               3. Have significant comorbidities, that in the judgment of the investigator makes\r\n                  the subject unsuitable for standard dose induction chemotherapy (e.g.\r\n                  anthracycline and infusional cytarabine given as 7+3), or;\r\n\r\n               4. Any patient age  70 years.\r\n\r\n          3. Blast count 20%\r\n\r\n          4. Greater than 25% of blasts must be CD33 positive.\r\n\r\n          5. Adequate renal and hepatic function\r\n\r\n          6. ECOG  3\r\n\r\n        Phase 2 Inclusion Criteria:\r\n\r\n          1. Untreated AML, including patients with an antecedent hematologic disorder or secondary\r\n             disease. Patients with prior MDS may have received therapy with immunomodulatory\r\n             agents for this diagnosis.\r\n\r\n          2. Patients age 60 years who:\r\n\r\n               1. Patients 60 years unfit to receive intensive (e.g., 7+3) chemotherapy who have:\r\n\r\n                    -  Congestive heart failure or documented cardiomyopathy with an EF 50%,\r\n                       provided that EF 35% or,\r\n\r\n                    -  Documented pulmonary disease with DLCO 65% or FEV1 65%, provided that\r\n                       patients do not require more than 2 L of oxygen per minute or,\r\n\r\n                    -  Documented liver disease with marked elevation of transaminases >3 x ULN or,\r\n\r\n                    -  Serum creatinine >1.2 mg/dL\r\n\r\n               2. Have significant comorbidities, that in the judgment of the investigator makes\r\n                  the subject unsuitable for standard dose induction chemotherapy (e.g.,\r\n                  anthracycline and infusional cytarabine given as 7+3); or\r\n\r\n               3. Any patient age  75 years.\r\n\r\n          3. Blast count  20% (WHO criteria)\r\n\r\n          4. Greater than 25% of blasts must be CD33 positive.\r\n\r\n          5. Have a circulating blast count of less than 200/mm3 (control with hydroxyurea or\r\n             similar agent is allowed);\r\n\r\n          6. Creatinine < 2.0 mg/dl\r\n\r\n          7. Estimated creatinine clearance  50ml/min\r\n\r\n          8. Bilirubin  2.0 mg/dl; AST and ALT < 5.0 times the ULN\r\n\r\n          9. Eastern Cooperative Oncology Group (ECOG) Performance Status  2\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients with acute promyelocytic leukemia\r\n\r\n          2. Treatment with chemotherapy or biologic therapy within 3 weeks, except for\r\n             hydroxyurea, which must be discontinued prior to treatment on study\r\n\r\n          3. Treatment with radiation within 6 weeks\r\n\r\n          4. Active serious infections uncontrolled by antibiotics\r\n\r\n          5. Active malignancy within 2 years of entry, except previously treated non-melanoma skin\r\n             cancer, carcinoma in situ or cervical intraepithelial neoplasia, and organ confined\r\n             prostate cancer with no evidence of progressive disease based on PSA levels and are\r\n             not on active therapy.\r\n\r\n          6. Clinically significant cardiac or pulmonary disease\r\n\r\n          7. Patients with liver cirrhosis\r\n\r\n          8. Active CNS leukemia. Patients with symptoms of CNS involvement, particularly those\r\n             with M4 or M5 subtypes, should undergo lumbar puncture prior to treatment on study to\r\n             exclude CNS disease. Symptoms include cranial neuropathies, other neurologic deficits,\r\n             and headache.\r\n\r\n          9. Psychiatric disorder that would preclude study participation\r\n      ","sponsor":"Actinium Pharmaceuticals","sponsor_type":"Industry","conditions":"AML","interventions":[{"intervention_type":"Drug","name":"Drug: Cytarabine (Phase 1 only)","description":"Low dose cytarabine administered at 20 mg subcutaneously every 12 hours for the first 10 days (Days 1 to 10) of every cycle. Cycle 1 can last up to 52 days (depending on the schedule of study drug dosing) in order to allow for recovery from Lintuzumab-Ac225. Cycles 2-12 will last 28 days each."},{"intervention_type":"Biological","name":"Biological: Lintuzumab-Ac225","description":"In Phase 1 the starting dose level was 1.0 Ci/Kg of Lintuzumab-Ac225 and 15 g/Kg unlabeled HuM195 divided into 2 equal fractionated doses (0.5 Ci/Kg and 7.5 g /Kg + 0.5 Ci/Kg and 7.5 g /Kg) with the first fraction administered approximately 4-7 days after 1 cycle of low dose cytarabine and the second fraction administered 4-7 days after the first fraction, followed by up to 11 more cycles. In Phase 2 the dose will be 4.0 Ci/Kg Lintuzumab-Ac225 and 25 g/Kg unlabeled HuM195 divided into 2 equal fractions with the first fraction given on Day 1 and the second fraction given on Day 5-8."},{"intervention_type":"Drug","name":"Drug: Furosemide (Phase 1 only)","description":"40 mg by mouth daily one day prior to treatment with Lintuzumab-Ac225 and continuing for 10 days following administration of the 2nd divided dose."},{"intervention_type":"Drug","name":"Drug: Spironolactone","description":"25 mg by mouth daily, administered 10 days after second dose of 225Ac-HuM195 and continued for 12 months."}],"outcomes":[{"outcome_type":"primary","measure":"Phase I: Maximum Tolerated Dose (MTD) of Lintuzumab-Ac225","time_frame":"Cycle 1, up to 52 days","description":"If two or more patients in a cohort experience dose limiting toxicity (DLT), then maximum tolerated dose (MTD) will have been exceeded, and no further dose escalation will occur. If only three patients were treated at a dose level under consideration as the MTD, then up to three additional patients will be accrued. If no more than one of the six patients at that dose level experiences DLT, then that dose level will be confirmed as the MTD."},{"outcome_type":"primary","measure":"Phase II: CR+CRp+CRi","time_frame":"First evaluation at 42 days after treatment","description":"The primary objective is to determine the antileukemic effects, including its ability to produce complete remissions, of Lintuzumab-Ac225."},{"outcome_type":"secondary","measure":"Phase II: PFS","time_frame":"1 year","description":"Progression Free Survival"},{"outcome_type":"secondary","measure":"Phase II: LFS","time_frame":"1 year","description":"Leukemia Free Survival"},{"outcome_type":"secondary","measure":"Phase II: OS","time_frame":"1 year","description":"Overall Survival"},{"outcome_type":"secondary","measure":"Phase II: Toxicity Spectrum","time_frame":"1 year"}]}
{"nct_id":"NCT01796210","start_date":"2012-10-31","enrollment":50,"brief_title":"Prediction of Hemodynamic Reactivity During Suspension Laryngoscopy Using Analgesia/Nociception Index (ANI)","official_title":"Prediction of Hemodynamic Reactivity During Suspension Laryngoscopy Using Analgesia/Nociception Index (ANI): an Observational Study","primary_completion_date":"2013-05-31","study_type":"Observational","rec_status":"Completed","completion_date":"2013-05-31","last_update":"2013-06-10","description":"The aim of this study is to evaluate the performance of Analgesia/Nociception Index for the prediction of hemodynamic reactivity in adult patients undergoing suspension laryngoscopy on general anesthesia.","other_id":"CPP 2012-046B","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":75,"population":"Adult patients underoing suspension laryngoscopy performed on general anesthesia","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age 18-75 years\r\n\r\n          -  Suspension laryngoscopy for diagnostic or therapeutic purposes\r\n\r\n          -  Total intravenous anesthesia using propofol and remifentanil\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  age <18 yrs or >75 yrs\r\n\r\n          -  arrythmia\r\n\r\n          -  administration of anticholinergic drugs or neuromuscular blockade reversal in the 20\r\n             previous minutes\r\n\r\n          -  psychiatric diseases\r\n\r\n          -  autonomic nervous system disorders (epilepsy)\r\n      ","sponsor":"Emmanuel Boselli","sponsor_type":"Other","conditions":"Anesthesia","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Change in heart rate and/or systolic blood pressure by more than 20% within 5 minutes","time_frame":"Before induction of anesthesia, 1 min after beginning of procedure, at steady-state anesthesia during procedure (an expected average of 10 min) and at arousal from general anesthesia in the end of procedure (an expected average of 20 min)"}]}
{"nct_id":"NCT01701492","start_date":"2012-10-19","enrollment":133,"brief_title":"Cognitive, Academic and Psychosocial Functioning in Long-Term Survivors of Pediatric Stem Cell Transplantation","official_title":"Cognitive, Academic and Psychosocial Functioning in Long-Term Survivors of Pediatric Stem Cell Transplantation","primary_completion_date":"2018-01-23","study_type":"Observational","rec_status":"Completed","completion_date":"2018-01-23","last_update":"2018-05-18","description":"This is an observational study to collect information by use of performance-based measures and survey questionnaires. It does not include interventions aimed at altering patient outcome. Advances in pediatric hematopoietic stem cell transplantation (SCT) have resulted in improved survival and prompted increased attention to the potential adverse late effects of this procedure. Survivors of SCT are thought to be at risk for neurocognitive deficits as a result of their exposure to a number of potentially neurotoxic agents. Prior studies done by our group and others have demonstrated generally stable cognitive function in the first 5 years following transplant, with little evidence of significant declines. However, there has been almost no research to date on the status of very long-term (> 5 years post-transplant) survivors. In this study, we will evaluate a large sample of long-term survivors of allogeneic SCT using measures of intelligence, academic achievement, and specific cognitive functions such as attention, working memory and processing speed. We will also obtain measures of behavioral functioning and quality of life. We will examine how this group of survivors are functioning relative to normative expectations, and in comparison to community controls without a history of serious illness, matched on age, gender, race/ethnicity, and socioeconomic status. We will also examine the relationship between cognitive function and psychosocial function and quality of life in this population.","other_id":"XPD12-077 BMTPE3","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":8,"population":"Survivors of SCT who are > 5 years since transplant and are returning for a transplant\r\n        clinic outpatient follow-up visit will be recruited to participate on study. We will\r\n        recruit patients beginning at age 8 years, with no upper age limit, although we anticipate\r\n        that most patients will be between 8 and 25 years at the time of assessment. For patients\r\n        in the age range 8-21 we will obtain data by both self- and parent-report. However, if\r\n        patients age 18-21 present to clinic without a parent, they will still be eligible for\r\n        study, and for these patients, as well as those  21 years, we will obtain performance\r\n        based and self-report measures only.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Treated with allogeneic bone marrow or stem cell transplant at St. Jude Children's\r\n             Research Hospital (SJCRH)\r\n\r\n          -   21 years at time of transplant\r\n\r\n          -  > 5 years from date of last transplant\r\n\r\n          -  Currently at least 8 years of age\r\n\r\n          -  English as primary language\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Transplanted for metabolic storage disorder, osteogenesis imperfecta, osteopetrosis,\r\n             or dyskeratosis congenita.\r\n\r\n          -  History of central nervous system (CNS) injury/disease predating or unrelated to\r\n             reason for SCT\r\n\r\n          -  Major sensory or motor impairment that would preclude valid cognitive assessment.\r\n             However, we will not exclude participants with mild cognitive impairments or special\r\n             educational needs.\r\n\r\n          -  Prior participation in BMTPE protocol at St. Jude Children's Research Hospital.\r\n\r\n        Control Group Inclusion Criteria\r\n\r\n          -  Age at least 8 years\r\n\r\n          -  No known history of serious illness\r\n\r\n          -  Demographic match to a St. Jude stem cell transplant patient\r\n\r\n        Control Group Exclusion Criteria\r\n\r\n          -  Major sensory or motor impairment that would preclude valid cognitive assessment.\r\n\r\n          -  History of specific CNS disease/injury (e.g., Down Syndrome, traumatic brain injury).\r\n             However, we will not exclude participants with mild cognitive impairments or special\r\n             educational needs.\r\n      ","sponsor":"St. Jude Children's Research Hospital","sponsor_type":"Other","conditions":"Stem Cell Transplant During Childhood|Allogeneic Bone Marrow Transplant During Childhood","interventions":[{"intervention_type":"Other","name":"Other: Questionnaire","description":"A one-time assessment using both performance-based measures as well as both self- and parent-report questionnaires."},{"intervention_type":"Other","name":"Other: Neurocognitive Evaluation","description":"A one-time neurocognitive evaluation conducted in the Psychology Clinic"}],"outcomes":[{"outcome_type":"primary","measure":"Intelligence and academic achievement","time_frame":"1 day","description":"To describe global cognitive and academic outcomes in this SCT cohort using measures of intelligence and academic achievement when compared to established normative data on well validated standardized instruments as well as to control participants in the community."},{"outcome_type":"primary","measure":"Performance in specific neuropsychologic domains.","time_frame":"1 day","description":"To examine performance in specific neuropsychologic domains, including working memory, processing speed and other executive functions compared to established normative data on well validated standardized instruments as well as to control participants in the community."},{"outcome_type":"primary","measure":"Psychosocial function","time_frame":"1 day","description":"To examine psychosocial function among long-term SCT survivors using both self- and parent-report compared to established normative data on well validated standardized instruments as well as to control participants in the community."},{"outcome_type":"primary","measure":"Quality of life","time_frame":"1 day","description":"To examine quality of life among long-term SCT survivors using both self- and parent-report compared to established normative data on well validated standardized instruments as well as to control participants in the community."}]}
{"nct_id":"NCT01601249","start_date":"2012-09-30","phase":"Phase 1","enrollment":0,"brief_title":"Improving IVF Embryo Quality Grading Using Polarized Light","official_title":"A Prospective Comparison Between Conventional IVF Embryo Grading and Polscope Based Grading","primary_completion_date":"2015-08-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2015-08-31","last_update":"2015-08-20","description":"Selecting one or two IVF embryos with the highest potential to implant is extremely important for the success of the treatment- obtaining pregnancies and avoiding multi-fetal gestations. The currently used IVF embryo grading method is based solely on embryo morphology (cleavage rate and fragmentation) just before the transfer, which is not very well correlated with the implantation potential of each embryo. Oocyte quality and adequacy are the most important factors determining the biological quality and implantation potential of the embryo. It impossible to grade oocytes using plain optical systems, other than maturity and gross anomalies. Polscope systems allow to visualize intra ooplasmic structures and determine their retardance, as well as that of the Zona Pellucida. The investigators hypothesize that grading embryos using the oocyte's parameters as visualized by polscope is superior to conventional morphology and correlates better with their implantation potential. Here the investigators will perform a prospective randomized controlled trial to examine this hypothesis.","other_id":"008212- HMO-CTIL","allocation":"Randomized","intervention_model":"Parallel Assignment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":38,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age 18-38, (near) normal MF, normal uterus, >4 aspirated oocytes, intent to transfer\r\n             1-2 embryos.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Severe MF problems, uterine anomalies, PGD, RIF.\r\n      ","sponsor":"Hadassah Medical Organization","sponsor_type":"Other","conditions":"Infertility","interventions":[{"intervention_type":"Procedure","name":"Procedure: Embryo selection based on polscope grading or morphology","description":"In the experimental arm embryo grading will be performed by polscope rather than conventional morphology, and the best embryo/s for transfer will be selected by this method."}],"outcomes":[{"outcome_type":"primary","measure":"Occurrence of clinical pregnancy","time_frame":"within 2 weeks after ET"},{"outcome_type":"secondary","measure":"Live birth","time_frame":"up to 40 weeks"}]}
{"nct_id":"NCT01686061","start_date":"2012-09-30","enrollment":124,"brief_title":"Blepharospasm Patient Survey for Patients With Blepharospasm","official_title":"Blepharospasm Patient Survey: A Structured Interview Evaluating Previous and Current incobotulinumtoxinA, abobotulinumtoxinA and onabotulinumtoxinA Treatment for Patients With Blepharospasm","primary_completion_date":"2013-04-30","study_type":"Observational","rec_status":"Completed","completion_date":"2013-04-30","last_update":"2014-04-08","description":"The purpose of this survey is to collect detailed information on patients treated for blepharospasm with incobotulinumtoxinA, abobotulinumtoxinA and onabotulinumtoxinA, including how often they are treated with botulinum toxin, how long their treatment lasts, how satisfied they are with their treatment, and if there is any improvement in their symptoms with the treatment.","other_id":"MUS6020100920","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":81,"population":"Patients treated for blepharospasm with incobotulinumtoxinA, abobotulinumtoxinA or\r\n        onabotulinumtoxinA treatment.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female subject aged > 18 years and < 81 years\r\n\r\n          -  Documented clinical diagnosis of blepharospasm\r\n\r\n          -  Currently receiving incobotulinumtoxinA, abobotulinumtoxinA or onabotulinumtoxinA\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Previous treatment with rimabotulinumtoxinB in the last 2 treatment cycles\r\n      ","sponsor":"Merz North America, Inc.","sponsor_type":"Industry","conditions":"Blepharospasm","interventions":[{"intervention_type":"Other","name":"Other: No intervention- only one time survey"}],"outcomes":[{"outcome_type":"primary","measure":"Botulinum Toxin Treatment Information","time_frame":"This is a single, structured interview about experiences with Botulinum Toxins","description":"The following information for patients treated for blepharospasm with incobotulinumtoxinA, abobotulinumtoxinA, or onabotulinumtoxinA treatment is collected: (1) botulinum treatment information such as intervals for botulinum injections, physician's rationale for injection interval, overall experience with botulinum toxin injections (onset, maximum effect, decline of effect), current injection cycle experience (current satisfaction, satisfaction at maximum effect, and visual analog scale (VAS) of current health status); and (2) disability status using the Blepharospasm Disability Index (BSDI) and the Jankovic Rating Scale (JRS)"}]}
{"nct_id":"NCT01887210","start_date":"2012-09-30","phase":"N/A","enrollment":66,"brief_title":"A Pilot Gaming Adherence Program for Youth Living With HIV","official_title":"A Pilot Gaming Adherence Program for Youth Living With HIV","primary_completion_date":"2017-01-09","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-08-31","last_update":"2018-09-26","description":"This study will develop and test a novel, technology based intervention to improve treatment adherence among youth living with HIV who are taking antiretroviral medication. In the intervention youth will access an engaging and immersive app/game on their smartphone.Data about the opening of the smart pill bottle will be transferred from the bottle cap wirelessly and will trigger a text message about their adherence. While gaming, participants will gain information about their health, improve motivation for ARV and medical appointment adherence, and practice healthy behaviors. If the Intervention is found to be effective, it can be tested in a larger study and then disseminated to other youth on antiretroviral medications.","other_id":"R01HD074846-01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":14,"maximum_age":26,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  English speaking\r\n\r\n          -  in medical care for HIV and receiving antiretroviral treatment\r\n\r\n          -  aware of their HIV status as per clinician and clinical record\r\n\r\n          -  able to give consent/assent and not impaired by cognitive or medical limitations as\r\n             per clinical assessment\r\n\r\n          -  detectable viral load\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  none\r\n      ","sponsor":"Rhode Island Hospital","sponsor_type":"Other","conditions":"Adherence to HIV Treatment and Medication","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: IMB Gaming Adherence Intervention","description":"Combination of smart pill bottle cap with mobile gaming application tailored for those living with HIV"},{"intervention_type":"Behavioral","name":"Behavioral: Enhanced treatment as usual","description":"Smart pill bottle cap and mobile phone but no game"}],"outcomes":[{"outcome_type":"primary","measure":"Log10 HIV-1 Viral Load","time_frame":"24 weeks","description":"Log viral load at end of study for participants with available viral load data (Log10 copies/ml)"},{"outcome_type":"secondary","measure":"Electronically Measured Past 7-day Adherence","time_frame":"24 weeks","description":"Past 7 day medication adherence as measured by electronic medication monitoring device."},{"outcome_type":"secondary","measure":"Number of Kept Medical Appointments","time_frame":"24 weeks","description":"Number of kept medical appointments since baseline."},{"outcome_type":"other","measure":"Information-Motivation-Behavioral Skills (IMB) Antiretroviral Therapy (ART) Behavioral Skills Scale","time_frame":"24 weeks","description":"Behavioral Skills subscale from the Information-Motivation-Behavioral Skills (IMB) scale. This subscale measures self-efficacy for adherence to medical care related to antiretroviral medication and treatment. Five items were summed to get a total Behavioral Skills subscale score. Scores range from 5-25 where higher scores indicate greater self-efficacy for adherence to medical care related to ART medication and treatment."}]}
{"nct_id":"NCT01651000","start_date":"2012-09-30","phase":"Phase 3","enrollment":213,"brief_title":"Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency","official_title":"A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of CTAP101 Capsules to Treat Secondary Hyperparathyroidism in Subjects With Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency","primary_completion_date":"2014-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-07-31","last_update":"2019-12-18","description":"This study will evaluate the efficacy of CTAP101 Capsules versus placebo in reducing intact parathyroid hormone (iPTH) by at least 30% from pretreatment baseline; safety and tolerability of CTAP101 will also be evaluated","other_id":"CTAP101-CL-3001","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Urinary albumin excretion  3000 mcg/mg of creatinine\r\n\r\n          2. Stage 3 or 4 CKD\r\n\r\n          3. Plasma iPTH:  85 pg/mL and < 500 pg/mL\r\n\r\n          4. Serum Ca:  8.4 mg/dL and < 9.8 mg/dL\r\n\r\n          5. Serum P:  2.0 mg/dL and < 5.0 mg/dL\r\n\r\n          6. Serum 25-hydroxyvitamin D:  10 ng/mL and < 30 ng/mL.\r\n\r\n          7. Stable dose of Vitamin D therapy  1600 IU/day and receiving same dose for at least 2\r\n             months\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. History of kidney transplant or parathyroidectomy\r\n\r\n          2. Spot urine calcium:creatinine ratio > 0.2 (>200 mg/g Cr)\r\n\r\n          3. Current serious illness, such as malignancy, HIV, liver disease, cardiovascular event\r\n             or hepatitis\r\n\r\n          4. Currently on dialysis\r\n\r\n          5. Use of pharmacological dose of ergocalciferol or cholecalciferol ( 50,000 IU mcg per\r\n             month) during the study\r\n      ","sponsor":"OPKO IP Holdings II, Inc.","sponsor_type":"Industry","conditions":"Chronic Kidney Disease|Hyperparathyroidism, Secondary|Vitamin D Deficiency","interventions":[{"intervention_type":"Drug","name":"Drug: CTAP101 30 g capsules","description":"CTAP101 30 g capsule taken daily at bedtime."},{"intervention_type":"Other","name":"Other: Sugar pill to CTAP101 30 g capsules","description":"Sugar pill capsule (placebo to CTAP101 30 g capsule) taken daily at bedtime."}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants in the Intent to Treat Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline Values","time_frame":"Approximately 6 months","description":"Number of subjects in the intent to treat population attaining a mean decrease in plasma intact parathyroid hormone (iPTH) of ≥30% from pre-treatment baseline in the efficacy assessment phase (EAP), referred to as responders."},{"outcome_type":"secondary","measure":"Number of Participants in the Per Protocol Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline Values","time_frame":"Approximately 6 months","description":"Number of subjects in the per protocol population attaining a mean decrease in plasma intact parathyroid hormone (iPTH) of ≥30% from pre-treatment baseline in the efficacy assessment phase (EAP), referred to as responders."},{"outcome_type":"secondary","measure":"Subjects in the Intent to Treat Population With Normal Serum Total 25-hydroxyvitamin D","time_frame":"Approximately 6 months","description":"Subjects in the Intent to Treat Population with normal serum total 25-hydroxyvitamin D (>/= 30 ng/dL)"},{"outcome_type":"secondary","measure":"Subjects in the Per Protocol Population With Normal Serum Total 25-hydroxyvitamin D","time_frame":"Approximately 6 months","description":"Subjects in the Per Protocol Population with normal serum total 25-hydroxyvitamin D (>/= 30 ng/mL)"}]}
{"nct_id":"NCT01648205","start_date":"2012-09-30","phase":"Phase 2","enrollment":55,"brief_title":"Efficacy Study of Sodium Channel Blocker in LQT3 Patients","official_title":"Ranolazine in LQT3 Patients","primary_completion_date":"2018-07-20","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-07-20","last_update":"2019-02-19","description":"The purpose of this study is to determine whether late sodium channel blockade might be effective in shortening the QTc interval in various LQT3 mutations and be considered as a safe therapeutic option for LQT3 patients.","other_id":"IN-US-259-0128","allocation":"Non-Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":21,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Genotyped positive for LQT3 (SCN5A) mutation\r\n\r\n          -  Age 21 years or older\r\n\r\n          -  Not currently taking an antiarrhythmic drug (beta blockers are allowed)\r\n\r\n          -  Enrolled in LQTS Registry\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Age less than 21 years\r\n\r\n          -  Not confirmed to have an LQT3 mutation\r\n\r\n          -  Significant co-morbidity that would preclude subject's safe participation in this\r\n             study\r\n\r\n          -  Females who are pregnant or nursing\r\n\r\n          -  Females of childbearing age who are not using acceptable method of birth control\r\n\r\n          -  Evidence of prior sensitivity to ranolazine\r\n\r\n          -  Hepatic or renal disease that might adversely affect ranolazine excretion\r\n\r\n          -  Currently taking strong CYP3A inhibitors\r\n\r\n          -  Currently taking P-gp inhibitors\r\n\r\n          -  Currently taking CYP3A inducers\r\n\r\n          -  In vitro studies of specific mutation show no effect of ranolazine on late sodium\r\n             current kinetics or show repolarization prolongation\r\n      ","sponsor":"University of Rochester","sponsor_type":"Other","conditions":"Long QT Syndrome","interventions":[{"intervention_type":"Drug","name":"Drug: Placebo","description":"Matching Placebo will be given"},{"intervention_type":"Drug","name":"Drug: Ranolazine","description":"Patients will receive ranolazine 1000mg bid or matching placebo"}],"outcomes":[{"outcome_type":"primary","measure":"QTc duration","time_frame":"At 2 and 6 months after baseline","description":"Change from baseline in QTc at 2 months and at 6 months"},{"outcome_type":"secondary","measure":"Change in Novel ECG, Echo, and Holter-derived markers from baseline at 2 and 6 months","time_frame":"At 2 months and 6 months","description":"The investigators will evaluate the effects of ranolazine on novel ECG, echo and Holter-derived markers to determine whether they could be even more sensitive regarding effects of drug on repolarization and its dynamics, measuring changes from baseline at 2 months and at 6 months."}]}
{"nct_id":"NCT01836536","start_date":"2012-09-30","phase":"N/A","enrollment":30,"brief_title":"Search for a Link Between Response to Treatment and Circulating Leucocytes in High Grade Glioma Patients","official_title":"Analysis of Different Circulating Immune Cells in Patients With Recurrent Glioblastoma or Mixed Anaplasic Glioma Treated With Bevacizumab and Search for a Link With Response to Treatment","primary_completion_date":"2015-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-08-31","last_update":"2017-03-01","description":"Bevacizumab, a monoclonal antibody against vascular endothelial growth factor (VEGF), is an antiangiogenic treatment currently proposed to recurrent high grade glioma patients. Unfortunately some patients fail to respond to this treatment and finding biological factors allowing the discrimination between potential responders and non responders would be very helpful. As the immune system plays a key role in angiogenesis induction and maintenance in cancer, it could serve as a surrogate marker of angiogenesis in cancer patients. The purpose of this study is to determine the influence of bevacizumab treatment on circulating immune cells in high grade glioma patients and to search for a link between the variation of these cells and the response to treatment.","other_id":"AVA-CELL","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with histologically proved recurrent glioblastoma or anaplasic glioma,\r\n\r\n          -  Tumor recurrence documented by MRI at least 3 months after the end of radiotherapy or\r\n             chemotherapy.\r\n\r\n          -  Patients for whom a treatment by bevacizumab is proposed by a multidisciplinary team\r\n             staff.\r\n\r\n          -  Age  18.\r\n\r\n          -  Signed informed consent.\r\n\r\n          -  Affiliation to a social security coverage\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Known Hepatitis B or C or HIV.\r\n\r\n          -  Inclusion in another clinical trial.\r\n\r\n          -  Patient having received an anti-angiogenic therapy.\r\n\r\n          -  Pregnant or breast-feeding woman.\r\n\r\n          -  Person deprived of liberty or under guardianship or trusteeship or judicial protection\r\n\r\n          -  Inability to give informed consent\r\n\r\n          -  Person unable or unwilling to comply with the requirements of the protocol for\r\n             geographical, social or psychological reasons.\r\n      ","sponsor":"Center Eugene Marquis","sponsor_type":"Other","conditions":"Glioblastoma|Glioma","interventions":[{"intervention_type":"Drug","name":"Drug: Bevacizumab standard of care","description":"Standard treatment associated with circulating leucocytes (blood samplings)"}],"outcomes":[{"outcome_type":"primary","measure":"blood cells populations","time_frame":"up to 4 months","description":"Analysis of blood cells populations variation during treatment with bevacizumab. Last sampling planned before the 7th cycle of bevacizumab."},{"outcome_type":"secondary","measure":"Cells variation and RMI response","time_frame":"6 weeks","description":"Relationship between variation of blood cells and RMI response after 6 weeks of treatment"},{"outcome_type":"secondary","measure":"Survival","time_frame":"Patients will be followed up from the date of randomization up to their death, assessed up to 100 months","description":"Link between variation of analyzed cellular population and survival."}]}
{"nct_id":"NCT01747460","start_date":"2012-09-30","enrollment":25,"brief_title":"Pulse Oximetry_Performance Testing- PCBA-1 (Printed Circuit Board Assembly)","official_title":"Controlled Acute Hypoxia Studies Using a Bedside Respiratory Patient Monitoring System With the Functional Patient Monitoring PCBA-1","primary_completion_date":"2012-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2012-12-31","last_update":"2013-12-06","description":"To determine accuracy specifications of the Pulse oximeter.","other_id":"COVMOPR0250","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":50,"population":"Healthy Subjects","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Male or female subjects between the ages of 18 to 50 years (inclusive).\r\n\r\n          2. Must undergo a physical examination by a licensed physician, advanced practice nurse\r\n             or physician assistant, including a 12 lead ECG, a medical history, and a blood test\r\n             checking complete blood count and screening for sickle cell trait or disease\r\n\r\n          3. All female volunteers must have a negative urine pregnancy test prior to\r\n             participation.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Pregnancy or lactating women\r\n\r\n          2. Unexplained syncopal episodes\r\n\r\n          3. Hypertension (defined as a systolic pressure of >145 mmHg or a diastolic pressure >90\r\n             mm Hg on three consecutive readings)\r\n\r\n          4. Premature ventricular contractions (PVC's) that are symptomatic or occur at a rate of\r\n             more than 5/minute\r\n\r\n          5. History of seizures (except childhood febrile seizures) or epilepsy\r\n\r\n          6. Routine use of tranquilizers and/or excessive anxiety\r\n\r\n          7. History of frequent headaches or migraines\r\n\r\n          8. History of stroke\r\n\r\n          9. Previous injury or trauma to fingers or hands that may change blood flow or vascular\r\n             supply and affect our ability to test multiple sensors\r\n\r\n         10. History of \"altitude sickness\" defined as headaches, malaise or dizziness when in the\r\n             mountains or in an aircraft at altitude significantly above sea level for a prolonged\r\n             period of time (> 1 hour)\r\n\r\n         11. History of significant respiratory disease, such as severe asthma, emphysema, etc.\r\n\r\n         12. Sickle cell disease or trait.\r\n\r\n         13. The use of medications, pre-existing medical conditions, treatment for a medical\r\n             condition or any other reason deemed relevant by the clinician conducting the study.\r\n\r\n         14. Abnormal ECG finding\r\n\r\n         15. Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g.,\r\n             Novocain)\r\n\r\n         16. Prior or known allergies to heparin.\r\n\r\n         17. History of transient ischemic attacks or carotid artery disease\r\n\r\n         18. History of myocardial ischemia, angina, myocardial infarction, congestive heart\r\n             failure or cardiomyopathy\r\n\r\n         19. History of chronic renal impairment\r\n\r\n         20. History of recent arterial cannulation (less than 1 month prior to study)\r\n\r\n         21. History of complications from previous arterial cannulation\r\n\r\n         22. Current use of blood thinners\r\n      ","sponsor":"Medtronic - MITG","sponsor_type":"Industry","conditions":"Healthy","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"SpO2 Accuracy (percentage of blood oxygen saturation)","time_frame":"Duration of subject visit- approx. 1.5 hours"}]}
{"nct_id":"NCT01669395","start_date":"2012-09-30","phase":"N/A","enrollment":80,"brief_title":"Severe Heart Failure and Homebased Rehabilitation - An Intersectoral Randomized Controlled Trial","official_title":"Early Homebased Rehabilitation for Patients With Severe Heart Failure - An Intersectoral Randomized Controlled Trial","primary_completion_date":"2015-09-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2016-07-31","last_update":"2012-08-21","description":"The purpose of this study is to investigate the effect of an early, coordinated rehabilitation intervention for patients with severe heart failure in NYHA class III and IV with a ejection fraction of <40% of normal cardiac function measured on frequency of readmissions, physical ability and participation in activities of daily living and quality of life.","other_id":"H-2-2012-021","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients admitted to the Gentofte Hospital due to heart failure.\r\n\r\n          -  Patients with a functional equivalent to NYHA grade III or IV\r\n\r\n          -  Patients with ejection fraction <40%\r\n\r\n          -  Patients who score between10-15 in the total score for question 3 dealing with\r\n             physical functioning in SF-36 questionnaire on health status\r\n\r\n          -  Patients who lives in Gentofte Municipality or Lyngby Trbk Municipality.\r\n\r\n          -  Patients who can speak and understand Danish\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with cognitive and psychological problems that prevents cooperation (aphasia,\r\n             dementia, severe depression).\r\n\r\n          -  Patients with terminal illness with expected death within a year.\r\n      ","sponsor":"University Hospital, Gentofte, Copenhagen","sponsor_type":"Other","conditions":"Chronic Heart Failure|Heart Failure NYHA Class II|Heart Failure NYHA Class III|Heart Failure NYHA Class IV","interventions":[{"intervention_type":"Other","name":"Other: Early homebased rehabilitation after hospital admission","description":"Training begins 3-5 days after discharge from hospital, performed by an occupational therapist and a physiotherapist from Gentofte Hospital in the first two weeks. From week three to six the training will be carried out by an occupational therapist and a physiotherapist from the local municipality (Gentofte municipality and Lyngby Taarbk municipality). Training will take place at home twice a week for 6 weeks, each session lasting 45 minutes. The intervention is individualized and focuses on functional physical and compensatory training to help the patient to manage everyday life at home. A training program will be provided and the patient will be instructed to do the exercises every day"},{"intervention_type":"Other","name":"Other: Usual care","description":"After discharge from the hospital the patients are offered the usual symptom-oriented and preventive medical care and psychosocial support"}],"outcomes":[{"outcome_type":"secondary","measure":"Quality of life","time_frame":"at baseline, after 6 weeks, after 6 month and after one year","description":"measured by The Minnesota Living with Heart Failure Questionnaire"},{"outcome_type":"secondary","measure":"Number of patients who starts outpatient cardiac rehabilitation after intervention (municipality or hospital)","time_frame":"at 6 weeks, after 6 month and after one year"},{"outcome_type":"primary","measure":"Readmission due to heart failure","time_frame":"assessed one year after inclusion"},{"outcome_type":"secondary","measure":"Physical capacity","time_frame":"Assessed at baseline, after 6 weeks, after 6 month and after one year","description":"measured by the Morton Mobility Index, Timed Up & Go and Modified Sit to Stand Test"},{"outcome_type":"secondary","measure":"Activity of Daily Living","time_frame":"Assessed at baseline, after 6 weeks, after 6 month and after one year","description":"Recorded at an ADL interview to assess the performance of everyday activities"},{"outcome_type":"secondary","measure":"Number of total hospital admissions","time_frame":"at baseline, after 6 weeks, after 6 month and after one year"},{"outcome_type":"secondary","measure":"Exercise Compliance","time_frame":"at baseline, after 6 weeks, after 6 month and after one year","description":"registration of exercise"},{"outcome_type":"secondary","measure":"Anxiety and depression","time_frame":"at baseline, after 6 weeks, after 6 month and after one year","description":"measured by Hospital Anxiety and Depression Scale (HAD)"}]}
{"nct_id":"NCT01681615","start_date":"2012-09-30","phase":"N/A","enrollment":50,"brief_title":"Challenge Test for Acetylsalicylic Acid Hypersensitivity","official_title":"Challenge Test for Acetylsalicylic Acid Hypersensitivity","primary_completion_date":"2013-03-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2013-12-31","last_update":"2012-09-13","description":"The investigators want to find new challenge test for Acetylsalicylic hypersensitivity / Aspirin hypersensitivity. The investigators suggest that this new test will be as efficient as the already established protocols in terms of sensitivity and specificity.","other_id":"ASA-ST-OS","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Persons between 18 and 60 years of age\r\n\r\n          -  Suspected Acetylsalicylic Acid Hypersensitivity\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History on anaphylactic shock after NSAIDS intake\r\n\r\n          -  History on gastric ulcer after NSAIDS intake\r\n\r\n          -  Patients previously gone through testing or desensitisation for Aspirin\r\n             hypersensitivity\r\n\r\n          -  Clinical unstable asthma or baseline FEV1<70%\r\n\r\n          -  Severe disease of the heart, digestive tract, liver or kidney\r\n\r\n          -  Severe chronic urticaria\r\n\r\n          -  Present conjunctivitis\r\n\r\n          -  Pregnancy\r\n      ","sponsor":"Helse Stavanger HF","sponsor_type":"Other","conditions":"Asthma Aspirin-sensitive|ASA Intolerant Asthma|Asthma, Aspirin-Induced|Asthma, Nasal Polyps, and Aspirin Intolerance","interventions":[{"intervention_type":"Drug","name":"Drug: Acetylsalicylate","description":"1-2 drops"},{"intervention_type":"Drug","name":"Drug: Isotonic NaCl","description":"1 drop"}],"outcomes":[{"outcome_type":"primary","measure":"Inspiratory nasal flow measured by Rhinomanometry","time_frame":"Within 45 min from challenge","description":"Bilateral flow reduction >40% considered positive test."},{"outcome_type":"primary","measure":"Expiratory nasal flow measured by Rhinomanometry","time_frame":"Within 45 min from challenge","description":"Bilateral expiratory flow reduction >40% considered positive."},{"outcome_type":"primary","measure":"Pulmonary forced expiratory volume in 1 second (FEV1)","time_frame":"Within 45 min from challenge","description":"Reduction in FEV1 >20% is considered as positive test."},{"outcome_type":"secondary","measure":"Conjunctival symptoms","time_frame":"Within 45 days from challenge","description":"0=no symptoms, 1=limited redness and / or itching, 2=conjunctival redness and /or itching / swelling or bullae within 5 minutes from testing.\r\nValue 1 and 2 is considered positive if unilateral."},{"outcome_type":"secondary","measure":"Nasal symptoms","time_frame":"Within 45 minutes from challenge","description":"Rhinorrhea, congestion and sneezing is considered as positive test."},{"outcome_type":"secondary","measure":"Bronchial and laryngeal symptoms","time_frame":"Within 45 minutes from challenge","description":"Bronchospasm. tight chest, wheezing or laryngospasm is considered as positive test."},{"outcome_type":"other","measure":"Other significant and relevant symptoms","time_frame":"Within 45 days after challenge","description":"Erythema in upper body or face, nausea or abdominal pain is considered as positive test."}]}
{"nct_id":"NCT01626391","start_date":"2012-09-30","phase":"Phase 2","enrollment":9,"brief_title":"Safety Study of TRx0237 in Patients Already Taking Medications for Mild and Moderate Alzheimer's Disease","official_title":"A Double-Blind, Placebo-Controlled, Randomised, 4-Week Safety and Tolerability Study of TRx0237 in Subjects With Mild to Moderate Alzheimer's Disease on Pre-Existing Stable Acetylcholinesterase Inhibitor and/or Memantine Therapy","primary_completion_date":"2013-03-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2013-03-31","last_update":"2014-07-11","description":"The primary purpose of this study is to assess the safety and tolerability of TRx0237 when taken at the same time as acetylcholinesterase inhibitors (i.e., donepezil, galantamine, or rivastigmine) and / or memantine to treat patients with mild to moderate Alzheimer's Disease.","other_id":"TRx-237-008","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","maximum_age":90,"population":"","criteria":"\n        Inclusion Criteria\r\n\r\n          -  Clinical diagnosis of all cause dementia and probable Alzheimer's disease (AD)\r\n\r\n          -  Mini-Mental State Examination (MMSE) score of 14-26 (inclusive)\r\n\r\n          -  Cognitive impairment present for at least 6 months\r\n\r\n          -  Age 90 years\r\n\r\n          -  Modified Hachinski ischaemic score of 4\r\n\r\n          -  Females, if of childbearing potential, must use adequate contraception and maintain\r\n             this use throughout participation in the study\r\n\r\n          -  Patient is able to read, understand, and provide written informed consent\r\n\r\n          -  Has one or more identified caregivers who are able to verify daily compliance with\r\n             study drug and provide information on safety and tolerability; the caregiver(s) must\r\n             also give consent to participate\r\n\r\n          -  Currently taking an taking an acetylcholinesterase inhibitor and/or memantine; the\r\n             subject must have been taking such medication(s) for 3 months. The dosage regimen\r\n             must have remained stable for 6 weeks and it must be planned to remain stable\r\n             throughout participation in the study.\r\n\r\n          -  Able to comply with the study procedures\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Significant central nervous system disorder other than Alzheimer's disease\r\n\r\n          -  Patients in whom baseline MRI is contraindicated such as metal implants in head\r\n             (except dental), pacemaker, and cochlear implant\r\n\r\n          -  Significant focal or intracranial pathology that would lead to a diagnosis other than\r\n             probable Alzheimer's disease\r\n\r\n          -  Clinical evidence or history of stroke, transient ischemic attack, significant head\r\n             injury or other unexplained or recurrent loss of consciousness\r\n\r\n          -  Epilepsy\r\n\r\n          -  Major depressive disorder, schizophrenia or other psychotic disorders, bipolar\r\n             disorder, substance (including alcohol) related disorders\r\n\r\n          -  Resides in a hospital or continuous care facility\r\n\r\n          -  History of swallowing difficulties\r\n\r\n          -  Pregnant or breastfeeding\r\n\r\n          -  History of significant hematological abnormality or current acute or chronic\r\n             clinically significant abnormality\r\n\r\n          -  Abnormal serum chemistry laboratory value at Screening deemed to be clinically\r\n             relevant by the investigator\r\n\r\n          -  Clinically significant cardiovascular disease or abnormal assessments\r\n\r\n          -  Pre-existing or current signs or symptoms of respiratory failure\r\n\r\n          -  Concurrent acute or chronic clinically significant immunologic, renal, hepatic, or\r\n             endocrine disease (not adequately treated) and/or other unstable or major disease\r\n             other than Alzheimer's disease\r\n\r\n          -  Prior intolerance to methylthioninium-containing drug or any of the excipients\r\n\r\n          -  Treatment currently or within 3 months before Baseline with any of the following\r\n             medications (unless otherwise noted):\r\n\r\n               -  Tacrine\r\n\r\n               -  Anxiolytics and/or sedatives/hypnotics (exceptions: sedation for MRI or\r\n                  occasional short-acting benzodiazepines, chloral hydrate, or zolpidem as needed\r\n                  at bedtime)\r\n\r\n               -  Antipsychotics (clozapine, chlorpromazine, thioridazine, or ziprasidone)\r\n\r\n               -  Carbamazepine\r\n\r\n               -  Drugs associated with methaemoglobinaemia (e.g., dapsone, local anesthetics such\r\n                  as benzocaine used chronically, primaquine and related antimalarials,\r\n                  sulfonamides)\r\n\r\n               -  Warfarin (and other Coumadin derivates such as phenprocoumon)\r\n\r\n          -  Current or prior participation in a clinical trial of a drug, biologic, or device in\r\n             which the last dose was received within 28 days prior to Baseline\r\n      ","sponsor":"TauRx Therapeutics Ltd","sponsor_type":"Industry","conditions":"Alzheimer's Disease","interventions":[{"intervention_type":"Drug","name":"Drug: TRx0237","description":"TRx0237 tablets 250 mg/day (given as 125 mg bid) for 4 weeks"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo tablets will be administered twice daily (b.i.d.) for 4 weeks. The placebo tablets include 4 mg of TRx0237 as a urinary and faecal colourant to maintain blinding; hence, the placebo group will receive a total of 8 mg/day of TRx0237."}],"outcomes":[{"outcome_type":"primary","measure":"Safety and Tolerability of TRx0237 When Coadministered With an Acetylcholinesterase Inhibitor (AChEI) and/or Memantine","time_frame":"8 weeks","description":"This was assessed by the number of participants who experienced adverse events within each treatment group (TRx0237 versus placebo) during 8 weeks of treatment."}]}
{"nct_id":"NCT01718236","start_date":"2012-09-30","phase":"Phase 4","enrollment":500,"brief_title":"Modern Myorelaxation Procedure and Reversal of Neuromuscular Blockade With General Anesthesia for Caesarean Section","official_title":"Modern Myorelaxation Procedure and Reversal of Neuromuscular Blockade With General Anesthesia for Caesarean Section","primary_completion_date":"2015-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-01-31","last_update":"2016-07-26","description":"The project aims to introduce into clinical practice for Caesarean section conducted under general anesthesia with the rapid induction myorelaxation with rocuronium and the reversal of neuromuscular blockade by using sugammadex. The aim is to demonstrate at least the same efficiency and confirm the safety of the procedure for both mother and newborn compared with older procedure.","other_id":"IGA NT 13906-4","allocation":"Randomized","intervention_model":"Factorial Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"Female","minimum_age":14,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  caesarian section under general anesthesia in informed patient (after interview with\r\n             anesthesiologist and obtain the signature for informed consent)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  patient disagreement\r\n\r\n          -  indicated and performed neuraxial blockade\r\n\r\n          -  the anesthesiologist or obstetrician opposition to their inclusion in the study\r\n\r\n          -  allergy or intolerance to one or more of study drug or known allergies or reactions to\r\n             iodine\r\n      ","sponsor":"Brno University Hospital","sponsor_type":"Other","conditions":"Pregnancy|Caesarean Section","interventions":[{"intervention_type":"Drug","name":"Drug: Rocuronium + sugammadex","description":"Administration of rocuronium 1 mg/kg, intubation at decrease in Single Twitch to 10% of baseline event. by the disappearance of visible spikes event. in the 60th seconds after administration of muscle relaxants. Anesthesia with sevoflurane according to the MAC, neuromuscular blockade TOF count at 1-2.At the end of operation at PTC 1-2 sugammadex 4 mg/kg, at the TOF count 1-2, sugammadex 2 mg/kg, in the case of failure to achieve these values the anesthesiologist will wait until the minimum value of PTC 1-2 will be achieved. In can not intubate can not ventilate, and the failure of the introduction of laryngeal masks sugammadex 16mg/kg, immediately following the discovery of this fact and wait for the recovery of muscle strength. Time to recovery is recorded."},{"intervention_type":"Drug","name":"Drug: Succinylcholine + Neostigmine","description":"1mg/kg succinylcholine iodide, intubation after decrease in Single Twitch to 10% of baseline event. after the disappearance of visible fasciculation event. in the 60th seconds after administration of muscle relaxants. Anesthesia with sevoflurane according to the MAC, at the moment of 20-30% of the original value of Single Twitch rocuronium 0.3 mg / kg, maintaining TOF Count at 1-2.At the end of operation at TOF Count 1-2 atropine 0.01 mg/kg and neostigmine 0.03 mg/kg. If TOF not 1-2 wait.In can not intubate can not ventilate, wait for the spontaneous recovery. Time to recovery of muscle strength is recorded."}],"outcomes":[{"outcome_type":"primary","measure":"time needed to tracheal intubation","time_frame":"2 years","description":"Quality: Rapid induction to general anesthesia with administration propofol and rocuronium for termination the pregnancy by Caesarean section are at least as good as the combination of propofol and succinylcholine iodide.Recording and evaluated will be the time from the beginning as the first drug in the rapid induction to general anesthesia will be administered until the discovery of the first wave of etCO2 after successful intubation (seconds), evaluation of intubation conditions (resistance to laryngoscopy, position of the vocal cords, response to the intubation attempt (limbs movement or cough) scored 1-3 according to level terms, conditions, entry scores for direct visualization of the vocal cords by Cormack-Lehane (I-IV)"},{"outcome_type":"secondary","measure":"total procedure time","time_frame":"2 years","description":"Economics: After reversal of neuromuscular blockade using sugammadex are procedure time and turnovers shorter than the use of neostigmine in the recommended dosage for patients undergoing termination of pregnancy by Caesarean section. Recording and evaluated will be the total procedure time until the recovery from neuromuscular blockade to the level of TOF ratio of 0.9, the administration of the recovery dose will in group ROCSUG in the case for posttetanic count mode in the level of PTC1, 2 at a dose of sugammadex 4mg/kg , the TOF count 1.2 sugammadex at a dose of 2 mg / kg, in the case of failure to achieve these values the anesthesiologist wil wait with the administration of the recovery dose for their achievement. In group SUCNEO for achieving TOF count 1.2 and higher, the dose of atropine to 0.01 mg / kg and neostigmine 0.03 mg / kg will be administered."},{"outcome_type":"other","measure":"complications during anesthesia and during perioperation period","time_frame":"2 years","description":"Rocuronium, sugammadex doesn´t lead to the deterioration of perinatal parameters and leads to fewer complications during anesthesia and postoperative period against a combination of succinylcholine iodide, rocuronium and neostigmine.Demographic characteristics (age,weight,BMI,gain in pregnancy,previous pregnancy, complications during pregnancy,medication during pregnancy), multiple gestation,parity,fetal position,the reason for the indication of caesarean section, the reason for general anesthesia caesarean section,week of termination of pregnancy,fetal weight,umbilical cord blood pH, pCO2,pO2,BE,Apgar,sex of the fetus,STAN or CTG assessment,the nature of amniotic fluid,time to cutting the umbilical cord will be monitored. Anesthesia complications (present or absent),the evaluation questionnaire of subjective feelings of the patient 1 day after caesarean section - sore throat,vigilance during anesthesia,myalgia,diplopia,weakness,inability to cough,shortness of breath will be recorded"}]}
{"nct_id":"NCT01676025","start_date":"2012-09-30","phase":"N/A","enrollment":83,"brief_title":"Comparison Between Posterior Retroperitoneoscopic Adrenalectomy and Laparoscopic Adrenalectomy","official_title":"Randomized Controlled Trial Between PRA(Posterior Retroperitoneoscopic Adrenalectomy) and LA(Laparoscopic Adrenalectomy)","primary_completion_date":"2016-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-02-28","last_update":"2017-10-06","description":"The purpose of this study is to compare two surgical methods of adrenalectomy. One is called PRA(posterior retroperitoneal adrenalectomy), which is performed through 3 or 4 holes at patient's back. The other is LA(laparoscopic adrenalectomy) which is performed through patient's abdominal cavity after making 3 or 4 holes in the abdomen.","other_id":"Kyu.eun.lee-001","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":79,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients who are expected to have benign adrenal disease at preoperative exams\r\n\r\n          -  Patients who have pheochromocytoma measured less than 5cm, and the other benign\r\n             adrenal tumors less than 7cm in diameter in preoperative CT scan\r\n\r\n          -  Patients who do not have previous surgery history at the interested quadrant\r\n\r\n          -  Patients who is I or II grade in ASA classification(American society of\r\n             anesthesiologists' physical status classification)\r\n\r\n          -  Patients who has tolerable liver function and renal function(bilirubin<2.0mg/dl and\r\n             AST, ALT, serum creatinine within twice of upper normal range, coagulation panel :\r\n             within normal limit)\r\n\r\n          -  Patients whose BMI(body mass index) is less than 35\r\n\r\n          -  Patients who are supposed to have normal cognitive function\r\n\r\n          -  Patients who signed the consent paper.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who are expected to have malignant or metastatic adrenal tumor at\r\n             preoperative exams\r\n\r\n          -  Patients who have bilateral adrenal tumors\r\n\r\n          -  Patients who have condition to undergo the other operation at the abdomen together\r\n             with adrenalectomy\r\n\r\n          -  Pregnant patients\r\n\r\n          -  Patients who have active or uncontrolled infection\r\n\r\n          -  Patients who have medical problems as below\r\n\r\n          -  Uncontrollable hypertension with medication(Systolic BP>150 or diastolic BP>100)\r\n\r\n          -  Angina, congestive heart failure, acute myocardial infection\r\n\r\n          -  History of coronary angioplasty or Coronary artery bypass graft surgery\r\n\r\n          -  History of stroke, transient ischemic attack with sequela\r\n      ","sponsor":"Seoul National University Hospital","sponsor_type":"Other","conditions":"Adrenal Disease","interventions":[{"intervention_type":"Procedure","name":"Procedure: LA"},{"intervention_type":"Procedure","name":"Procedure: PRA"}],"outcomes":[{"outcome_type":"primary","measure":"Operation time","time_frame":"Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks","description":"operation time will be measured by attending nerse"},{"outcome_type":"secondary","measure":"Pain sensation after surgery","time_frame":"Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks","description":"Pain score will be described daily during hospitalization, and also at out patient clinic after discharge"},{"outcome_type":"secondary","measure":"Recovery of bowel movement","time_frame":"Participants will be followed the duration of hospital stay, an expected average of 5 days","description":"Gas out is regarded as a recovery of bowel movement"},{"outcome_type":"secondary","measure":"Wound complication","time_frame":"Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks"},{"outcome_type":"secondary","measure":"Blood loss during operation","time_frame":"Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks"},{"outcome_type":"secondary","measure":"Intra-operative hemodynamic status","time_frame":"Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks","description":"Events as below will be recorded and compared severe hypertension(systolic BP>200mmHg), severe hypotension(systolic BP<90mmHg), Tachycardia(HR>110/min), Bradycardia(HR<50/min)"}]}
{"nct_id":"NCT01761812","start_date":"2012-09-30","phase":"N/A","enrollment":5,"brief_title":"Multiparametric MRI for Prostate Cancer Localization and Characterization: New Methods","official_title":"Determining the Extent and Grade of Prostate Cancer Using MR Elastography, Diffusion Weighted Imaging, and Dynamic Contrast Enhanced MRI With Gadofosveset","primary_completion_date":"2014-12-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2014-12-31","last_update":"2016-10-18","description":"The purpose of this study is to determine the ability of several new MRI techniques (MR elastography, dynamic contrast-enhanced MRI with gadofosveset, and oscillating gradient diffusion) to determine the location, size, and grade of prostate carcinoma. Thirty patients with biopsy proven carcinoma awaiting prostatectomy will be included in the study. Ex-vivo MRI will also be conducted on the prostate specimen to obtain high resolution imaging correlates to both in-vivo MRI and whole mount prostatectomy specimens. The investigators hypothesize that the addition of these three techniques will increase the accuracy, sensitivity, and specificity of MRI for detecting clinically significant prostate cancer.","other_id":"334-2011","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  male patients diagnosed with T1C or T2 prostate cancer, awaiting prostatectomy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  unable to give informed consent\r\n\r\n          -  contraindication to MRI or MRI contrast agent\r\n\r\n          -  claustrophobia\r\n\r\n          -  renal impairment\r\n\r\n          -  prior hormonal or radiation therapy for prostate cancer\r\n\r\n          -  active prostatitis\r\n\r\n          -  moderate to severe rectal inflammation\r\n\r\n          -  previous rectal surgery\r\n\r\n          -  prostate biopsy within 4 weeks of planned MRI\r\n      ","sponsor":"Sunnybrook Health Sciences Centre","sponsor_type":"Other","conditions":"Prostate Cancer","interventions":[{"intervention_type":"Other","name":"Other: MRI with gadofosveset and MR elastography"}],"outcomes":[{"outcome_type":"primary","measure":"Correlation coefficient","time_frame":"This outcome measure will be assessed approximately 4 weeks following prostatectomy (an average of 8 weeks from time of enrolment).","description":"Correlation coefficient between the expected location and grade of prostate cancer as determined by each new MRI method compared with whole mount histological specimen using a 5 mm grid for spatial reference."},{"outcome_type":"primary","measure":"Receiver operator characteristic curve for the prediction of prostate cancer for each new MRI method","time_frame":"This outcome measure will be assessed approximately 4 weeks following prostatectomy (an average of 8 weeks from time of enrolment)."}]}
{"nct_id":"NCT01511679","start_date":"2012-09-30","enrollment":0,"brief_title":"Brain-imaging and Adolescent Neuroscience Consortium","official_title":"Brain-imaging and Adolescent Neuroscience Consortium","primary_completion_date":"2017-03-31","study_type":"Observational","rec_status":"Withdrawn","completion_date":"2017-09-30","last_update":"2013-01-03","description":"This is a multi-site study of adolescents 12-21 years-of-age to evaluate the long and shorter-term effect of adolescent alcohol use on the developing brain.","other_id":"BANC RFA-AA-12-006","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":12,"maximum_age":21,"population":"Male and female adolescents 12-21 years-of-age presenting for care at one of the\r\n        participating medical clinics","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  able to read and understand English\r\n\r\n          -  available for follow-up\r\n\r\n          -  parental consent/adolescent assent for those 12-17 years\r\n\r\n          -  consent for those 18-21 years\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Weight > 300 lbs\r\n\r\n          -  braces or unremovable embedded metal\r\n\r\n          -  claustrophobia or inability to lie still in MRI machine\r\n\r\n          -  current or past 12-mos pregnancy (females)\r\n\r\n          -  requires urgent medical/mental health care\r\n      ","sponsor":"Boston Children's Hospital","sponsor_type":"Other","conditions":"Alcohol Abuse","interventions":{},"outcomes":{}}
{"nct_id":"NCT01680120","start_date":"2012-09-30","phase":"Phase 4","enrollment":15,"brief_title":"Dose Finding Study for Continuous Spinal Anaesthesia","official_title":"Determination of the Minimum Local Anaesthetic Needed for Operative Fixation of Fractured Neck of Femur With Continuous Spinal Anaesthesia","primary_completion_date":"2012-11-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2012-12-31","last_update":"2012-09-06","description":"Fixation of fractured neck of femur is a common Orthopedic surgery. Anaesthesia can be challenging in some cases like in haemodynamical unstable patients. The investigators have evidence of minimum effective local anaesthetic dose (MLAD) in hip replacement surgery but MLAD to achieve surgical anaesthesia for operative fixation of FNF is still unknown. A step-up/step-down methodology was used successfully in regional anaesthesia and also in other areas of anaesthesia. In pregnant ladies in whom spinal anaesthesia is performed on the side, significant correlation exist between the vertebral length measured from cervical 7 to the iliac creast and MLAD. The investigators aim it was to determine the MLAD of hyperbaric 0.5% bupivacaine required for Continuous spinal anaesthesia for the operative fixation of FNF.","other_id":"CUH07/03/2012","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Above 60 years\r\n\r\n          -  ASA I to III patients\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patient refusal\r\n\r\n          -  Outside Age Range\r\n\r\n          -  Coagulation disorders\r\n\r\n          -  Head injury or other associated injuries\r\n\r\n          -  Loss of consciousness and signs of acute coronary syndrome\r\n\r\n          -  Mini-Mental Score < 25\r\n\r\n          -  Allergy to bupivacaine, lignocaine\r\n\r\n          -  Skin lesions/infection at site of injection\r\n\r\n          -  Sepsis\r\n      ","sponsor":"Cork University Hospital","sponsor_type":"Other","conditions":"Femoral Fracture","interventions":[{"intervention_type":"Procedure","name":"Procedure: Continuous spinal anaesthesia","description":"Standard monitoring including continuous electrocardiogram, noninvasive automated arterial blood pressure and pulse oximetry will be applied.\r\nSubarachnoid puncture will be performed with a 18-gauge Tuohy needle at the L4-5 or L3-4 interspace using a midline approach. Three cm of a 22-gauge catheter will be introduced cephalad through the needle. The initial dose is arbitrarily chosen as 1 ml of 0.5 % isobaric bupivacaine on the basis of clinical experience, the local anaesthetic will be injected through the catheter over 5-10 s. After completion of injection the patients remain in the lateral position for 5 min and then will be returned to the supine position.\r\nSuccessive injections of 0.2 ml of 0.5 % isobaric bupivacaine will be performed every 15 min until a satisfactory sensory level is obtained (T12)."}],"outcomes":[{"outcome_type":"primary","measure":"MLAD of 0.5 % bupivacaine for operative fixation of fractured neck of femur patients","time_frame":"In every 15 minutes after performing spinal anaesthesia the spinal block will be assessed","description":"Subarachnoid puncture will be performed with a 18-gauge Tuohy needle at the L4-5 or L3-4 interspace using a midline approach. Three cm of a 22-gauge catheter will be introduced cephalad through the needle. The initial dose is arbitrarily chosen as 1 ml of 0.5 % isobaric bupivacaine on the basis of clinical experience, the local anaesthetic will be injected through the catheter over 5-10 s."},{"outcome_type":"secondary","measure":"MLAD/ vertebral length","time_frame":"In every 15 minutes after performing spinal anaesthesia the spinal block will be assessed"},{"outcome_type":"secondary","measure":"Pain experienced by the patients in the operating theatre.","time_frame":"In every 15 minutes after performing spinal anaesthesia the spinal block will be assessed"},{"outcome_type":"secondary","measure":"Patient satisfaction after surgery regarding pain relief.","time_frame":"In every 15 minutes after performing spinal anaesthesia the spinal block will be assessed"},{"outcome_type":"secondary","measure":"Difference (if any) in effect on haemodynamic variables (i.e. heart rate and blood pressure).","time_frame":"After performing spinal anaesthesia the blood pressure will be measured in every three minutes, ECG and pulse oximetry will me recorded continuously"},{"outcome_type":"secondary","measure":"Side effects of medication","time_frame":"After performing spinal anaesthesia the blood pressure will be measured in every three minutes, ECG and pulse oximetry will me recorded continuously"}]}
{"nct_id":"NCT01705548","start_date":"2012-09-24","phase":"N/A","enrollment":25,"brief_title":"Hypofractionated Stereotactic Radiosurgery in Treating Patients With Large Brain Metastasis","official_title":"Phase I Dose Escalation Trial of Hypofractionated Radiosurgery for Large Brain Metastasis","primary_completion_date":"2022-12-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2022-12-31","last_update":"2021-06-18","description":"This phase I trial studies the side effects and best dose of hypofractionated radiosurgery in treating patients with large brain metastasis. Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. Giving fractionated stereotactic radiosurgery may kill more tumor cells.","other_id":"IRB00055063","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Pathologic proven diagnosis of solid tumor malignancy\r\n\r\n          -  Solitary brain metastasis or brain metastasis resection cavity with maximal diameter \r\n             3 cm (or  14 cc.) and  6 cm (or  113 cc.)\r\n\r\n          -  Mini Mental Status Exam (MMSE)  18 prior to study entry\r\n\r\n          -  Recursive partitioning analysis (RPA) class I-II/ Karnofsky Performance status (KPS) \r\n             70%\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior stereotactic radiosurgery (SRS) to adjacent lesion such that planning target\r\n             volume would have received more than 12 Gy\r\n\r\n          -  RPA class III (KPS < 70%)\r\n\r\n          -  Brain metastasis or resection cavity volume < 3 cm or > 6 cm\r\n\r\n          -  Radiosensitive or non-solid (eg. small cell lung carcinomas, germ cell tumors,\r\n             leukemias, or lymphomas) or unknown tumor histologies\r\n\r\n          -  Concurrent chemotherapy (no chemotherapy starting 14 days before start of radiation)\r\n\r\n          -  Evidence of leptomeningeal disease by magnetic resonance imaging (MRI) and/or\r\n             cerebrospinal fluid (CSF) cytology\r\n\r\n          -  Current pregnancy\r\n\r\n          -  More than 8 weeks between resection and radiosurgical procedure\r\n\r\n          -  Metastases to brain stem, midbrain, pons, or medulla or within 5 mm of the optic\r\n             apparatus (optic nerves and chiasm)\r\n\r\n          -  Inability to undergo MRI evaluation for treatment planning and follow-up\r\n      ","sponsor":"Emory University","sponsor_type":"Other","conditions":"Metastatic Malignant Neoplasm to Brain|Unspecified Adult Solid Tumor, Protocol Specific","interventions":[{"intervention_type":"Radiation","name":"Radiation: Hypofractionated Radiosurgery","description":"Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week."}],"outcomes":[{"outcome_type":"secondary","measure":"Freedom from failure/progression free survival","time_frame":"Up to 2 years"},{"outcome_type":"primary","measure":"Maximum tolerated dose (MTD) of hypofractionated radiosurgery defined as the highest dose level where a grade 3 or greater with an attribution score of ≥ 3 develops in ≤ 2 of 6 patients in a dose group","time_frame":"4 months","description":"Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. The rate of toxicities will be calculated with 95% confidence interval (CI)."},{"outcome_type":"primary","measure":"Neurologic toxicity due to treatment, graded according to the CTCAE version 4.03","time_frame":"Up to 2 years","description":"Calculated with 95% CI."},{"outcome_type":"secondary","measure":"Local control; lack of progression of disease in resection cavity as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria","time_frame":"4 months","description":"The median time to local brain progression will be calculated by Kaplan-Meier method with 95% CI."},{"outcome_type":"secondary","measure":"Distant control: lack of progression of disease in surrounding brain as defined by RECIST criteria","time_frame":"4 months","description":"The median time to distant brain progression will be calculated by Kaplan-Meier method with 95% CI."},{"outcome_type":"secondary","measure":"Overall survival (OS): death from any cause","time_frame":"Up to 2 years","description":"The median of OS time with 95% CI will be calculated by Kaplan-Meier method."},{"outcome_type":"secondary","measure":"Long-term neurocognitive outcomes: using the Hopkins Verbal Learning Test-Revised (HVLT-R), Mini Mental Status Exam (MMSE) and Cognitive Functioning Subscale of the Medical Outcomes Scale (MOS)","time_frame":"Up to 2 years","description":"Neurocognitive effect will be regressed over time using generalized estimating equation (GEE) model. The population change over time (slope) will be estimated with 95% CI."},{"outcome_type":"secondary","measure":"Quality of life (QOL) outcomes: using the quality of life questionnaire for the Functional Assessment of Cancer Therapy-Brain (FACT-Br).","time_frame":"Up to 2 years","description":"QOL outcomes will be regressed over time using GEE model. The population change over time (slope) will be estimated with 95% CI."}]}
{"nct_id":"NCT01682473","start_date":"2012-09-20","phase":"Phase 1","enrollment":20,"brief_title":"A Study of ZSTK474 in Japanese Patients With Advanced Solid Malignancies","official_title":"A Phase 1, Multi-Center, Open Label, Uncontrolled, Serial Cohort, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of ZSTK474 in Japanese Patients With Advanced Solid Malignancies","primary_completion_date":"2015-04-02","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-04-20","last_update":"2017-07-06","description":"To evaluate the safety (adverse events and dose-limiting toxicity) of daily oral doses of ZSTK474 in patients with advanced solid malignancies.","other_id":"ZSTK474-201","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Japanese males or females >= 20 years old\r\n\r\n          -  Advanced (metastatic or unresectable) solid tumor\r\n\r\n          -  ECOG performance status score of 0 or 1 and expected survival >12 weeks\r\n\r\n          -  Recovered from hematological toxicities of prior cancer therapies\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Previous treatment with PI3K inhibitor\r\n\r\n          -  Serious/significant illnesses or underlying conditions, including diabetes or hepatic\r\n             renal or CV disease.\r\n\r\n          -  Other investigational agent within previous 4 weeks\r\n\r\n          -  Participating in another clinical study\r\n      ","sponsor":"Zenyaku Kogyo Co., Ltd.","sponsor_type":"Industry","conditions":"Neoplasms","interventions":[{"intervention_type":"Drug","name":"Drug: ZSTK474","description":"Two arms, each with serial cohorts receiving escalating doses."}],"outcomes":[{"outcome_type":"primary","measure":"Number of participants with dose-limiting toxicities","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Pharmacokinetics (Cmax, tmax, t½, AUC)","time_frame":"28 days"}]}
{"nct_id":"NCT01532414","start_date":"2012-08-31","phase":"Phase 3","enrollment":151,"brief_title":"Phase III Study to Evaluated Morning Testosterone Normalization in Men With Secondary Hypogonadism","official_title":"A Randomized, Double Blind, Placebo Controlled Multi-Center Phase III Study to Evaluate Normalization of Morning Testosterone Levels in Overweight Men With Acquired Hypogonadotropic Hypogonadism and Normal Sperm Concentration","primary_completion_date":"2013-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-03-31","last_update":"2015-05-27","description":"The purpose of ZA-301 is to determine the effects of Androxal on morning testosterone and reproductive status in younger overweight men with acquired hypogonadotropic hypogonadism (confirmed morning T<300 ng/dL) and normal sperm concentration, compared to changes with placebo. Subjects must not have previously been treated with testosterone products within the last 6 months.","other_id":"ZA-301","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Overweight (BMI 25 to 42 kg/m2 inclusive) males age 18 to 60 inclusive\r\n\r\n          2. All clinical laboratory tests within normal ranges (any clinically significant\r\n             deviation of laboratory results will require approval of sponsor)\r\n\r\n          3. Previously or concurrently diagnosed as having secondary hypogonadism characterized as\r\n             having 2 consecutive morning testosterone assessments < 300ng/dL, one of which must be\r\n             confirmed at Baseline.\r\n\r\n          4. LH < 9.4 mIU/mL (at Visit 1 only)\r\n\r\n          5. Sperm count  15 million per milliliter (assessed twice at least 48 hours apart)\r\n\r\n          6. Ability to complete the study in compliance with the protocol\r\n\r\n          7. Ability to understand and provide written informed consent\r\n\r\n          8. Agreement to provide a total of up to 6 semen sample in a sponsor-approved clinic on\r\n             up to 6 separate occasions.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Any prior use of testosterone treatments within the last 6 months\r\n\r\n          2. Use of spironolactone, cimetidine, Clomid, 5-reductase inhibitors, hCG, androgen,\r\n             estrogen, anabolic steroid, DHEA, or herbal hormone products during the study\r\n\r\n          3. Use of Clomid in the past year\r\n\r\n          4. Uncontrolled hypertension or diabetes mellitus based on the Investigator's assessment\r\n             at baseline. Subjects treated for Type II diabetes will be allowed into the study.\r\n             Newly diagnosed diabetics need to be treated for at least 48 hours before being\r\n             enrolled in the study.\r\n\r\n          5. Clinically significant abnormal findings at Screening (Visit 1) or Baseline, based on\r\n             the Investigator's assessment\r\n\r\n          6. A hematocrit >54% or a hemoglobin >17 g/dL (sponsor may approve enrollment of subjects\r\n             with hemoglobin up to 17.5 g/dL if the subject is at a location with a high elevation)\r\n\r\n          7. Use of an investigational drug or product, or participation in a drug or medical\r\n             device research study within 30 days prior to receiving study medication.\r\n\r\n          8. Known hypersensitivity to Clomid\r\n\r\n          9. Symptomatic cataracts (nuclear sclerosis cataract or cortical cataract grade > 2 based\r\n             on 0-4 scale or any trace of posterior subcapsular cataract)\r\n\r\n         10. Abnormal fundoscopy exam such as central retinal vein occlusion\r\n\r\n         11. Any condition which in the opinion of the investigator would interfere with the\r\n             participant's ability to provide informed consent, comply with study instructions,\r\n             possibly confound interpretation of study results, or endanger the participant if he\r\n             took part in the study\r\n\r\n         12. Irreversibly infertile or compromised fertility (cryptorchism, Kallman Syndrome,\r\n             primary hypogonadism, vasectomy, or tumors of the pituitary)\r\n\r\n         13. Current or history of breast cancer\r\n\r\n         14. Current or history of prostate cancer or a suspicion of prostate disease unless ruled\r\n             out by prostate biopsy, or a PSA>3.6\r\n\r\n         15. Presence or history of known hyperprolactinemia with or without a tumor\r\n\r\n         16. Chronic use of medications such as glucocorticoids\r\n\r\n         17. History of drug abuse or chronic narcotic use including methadone\r\n\r\n         18. A recent history of alcoholism or illegal substance or steroid abuse (<2 years) or\r\n             presence of moderate alcohol use (>21 drinks per week)\r\n\r\n         19. Subjects with known history of HIV and/or Hepatitis C\r\n\r\n         20. Subjects with end stage renal disease\r\n\r\n         21. History of liver disease (including malignancy) or a confirmed AST or ALT >3 times the\r\n             upper limit of normal\r\n\r\n         22. History of myocardial infarction, unstable angina, symptomatic heart failure,\r\n             ventricular dysrhythmia or know history of QTc interval prolongation\r\n\r\n         23. History of cerebrovascular disease\r\n\r\n         24. History of venous thromboembolic disease (e.g. deep vein thrombosis or pulmonary\r\n             embolism)\r\n\r\n         25. History of erythrocytosis or polycythemia\r\n\r\n         26. Subjects with cystic fibrosis (mutation of the CFTR gene)\r\n\r\n         27. Subjects unable to provide a semen sample in a sponsor-approved clinic\r\n\r\n         28. Enrollment in a previous Androxal study\r\n      ","sponsor":"Repros Therapeutics Inc.","sponsor_type":"Industry","conditions":"Secondary Hypogonadism","interventions":[{"intervention_type":"Drug","name":"Drug: Androxal","description":"oral, capsules, taken one time daily, for 3 months"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Oral capsule taken one time daily for 3 months"}],"outcomes":[{"outcome_type":"primary","measure":"Proportion (Percentage) of Androxal Treated Subjects With Testosterone in the Normal Range","time_frame":"3 months","description":"Proportion of pooled Androxal subjects with average serum concentration (Cavg) for T in the normal range (300 - 1040 ng/dL) after 12 weeks of treatment. Cavg will be calculated as the numerical average of 24-hour serial testosterone assessments at 0, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours after dosing.\r\nIf the lower limit of the 95% confidence interval for the Androxal treatment group at Week 12 is at least 67%, then the co-primary endpoint based on the Cavg for testosterone has been achieved.\r\nFDA specified primary endpoint did not include comparison to placebo, thus the proportion of placebo subjects with average serum concentration (Cavg) for T in the normal range (300 - 1040 ng/dL) after 12 weeks of treatment was not calculated."},{"outcome_type":"primary","measure":"Subjects With 50% or Greater Decrease in Sperm Concentration Comparison of Proportion of Subjects With 50% or Greater Decrease in Sperm","time_frame":"3 months","description":"Proportion of subjects with a 50% or greater decrease in sperm concentration from baseline after 12 weeks of treatment in Androxal treated subjects to placebo.\r\nThe difference between the proportions (placebo minus Androxal) and corresponding 95% confidence interval was determined and compared to the equivalence limit of -20%. If the lower limit of the 95% confidence interval was greater than -20%, then Androxal would be concluded to be non-inferior to placebo in causing a 50% reduction in sperm concentrations."}]}
{"nct_id":"NCT01624064","start_date":"2012-08-31","phase":"Phase 1/Phase 2","enrollment":200,"brief_title":"Renal Effects of an Angiotensin Converting Enzyme Inhibitor in Adults With Chronic Kidney Disease of Uncertain Aetiology","official_title":"A Double Blind Clinical Trial to Examine the Renal Effects of an Angiotensin Converting Enzyme Inhibitor (Enalapril) in Adults With Chronic Kidney Disease of Uncertain Aetiology (CKDu)","primary_completion_date":"2012-10-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2013-10-31","last_update":"2012-06-20","description":"Enalapril would significantly reduce progression of renal disease in patients with Chronic Kidney Disease of Uncertain aetiology.","other_id":"NSF CKDu Research","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Males and females between 18-70 years of age\r\n\r\n          -  CKDu Grade 1, 2, 3\r\n\r\n          -  No contraindication for treatment with ACEI\r\n\r\n          -  Informed consent given\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Grade 4 CKDu\r\n\r\n          -  Other chronic diseases\r\n\r\n          -  Evidence or suspicion of non renal secondary hypertension\r\n\r\n          -  Diabetes type 1 or 2\r\n\r\n          -  Evidence or suspicion of renovascular disease, obstructive uropathy, or other renal\r\n             disease\r\n\r\n          -  Treatment with corticosteroids, non-steroidal anti-inflammatory drugs, or\r\n             immune-suppressive drugs\r\n\r\n          -  Acute myocardial infarction or cerebrovascular accident in the previous 6 months\r\n\r\n          -  Severe uncontrolled hypertension (diastolic blood pressure 115 and/or systolic blood\r\n             pressure 220 mm Hg)\r\n\r\n          -  Suspicion or evidence of connective tissue disease, cancer, higher serum\r\n             aminotransferase concentrations\r\n\r\n          -  Chronic cough; drug or alcohol abuse; pregnancy and breast feeding\r\n\r\n          -  Unwillingness to sign informed consent\r\n      ","sponsor":"Ministry of Health, Sri Lanka","sponsor_type":"Other","conditions":"Renal Insufficiency, Chronic","interventions":[{"intervention_type":"Drug","name":"Drug: Enalapril","description":"2.5-20 mg/day"},{"intervention_type":"Drug","name":"Drug: Calcium Supplement","description":"Calcium 2.5-20 mg/day"}],"outcomes":[{"outcome_type":"primary","measure":"Proteinuria","time_frame":"One year","description":"Numerous clinical trials have established that angiotensin-converting enzyme inhibitors (ACEI) are beneficial in slowing progression of renal disease. However the long-term renal effect of these agents in early renal disease is not well demonstrated. In fact the trials which showed benefits with ACEI did show in glomerular disease and evidence is not so strong in tubulo-interstitial disease."},{"outcome_type":"primary","measure":"Estimated GFR","time_frame":"One year","description":"In most forms of proteinuric chronic renal disease, glomerular filtration rate continues to decline even when the initial insult has been removed. The cause of CKDu is still unknown. CKDu is a tubulo-interstitial disease with low grade proteinuria. We believe that the place of ACEI for secondary prevention of CKDu progression needs investigation."},{"outcome_type":"secondary","measure":"All cause mortality","time_frame":"One year"},{"outcome_type":"secondary","measure":"Cardiovascular mortality","time_frame":"One year"}]}
{"nct_id":"NCT01811680","start_date":"2012-08-31","phase":"Phase 1","enrollment":10,"brief_title":"An Exploratory Clinical Study on a Variable Speed and Sensing Treadmill System (VASST) for Hemiparetic Gait Rehabilitation","official_title":"A Phase 1 Study of \"An Exploratory Feasibility Clinical Study on a Variable Speed and Sensing Treadmill System (VASST) for Hemiparetic Gait Rehabilitation in Subacute Stroke Patients.\"","primary_completion_date":"2013-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-07-31","last_update":"2015-01-05","description":"To conduct a feasibility clinical trial to test a novel patient sensing automated treadmill device devised by local engineers for subacute hemiplegic stroke patients for gait rehabilitation. This is a phase 1 feasibility and safety trial on the above device for 10 chronic stroke patients with hemiparetic gait dysfunction to be conducted over a period of 2 months. Research protocol and standardized outcomes measures will be used.","other_id":"NHG DSRB_D_2012/00571","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. First ever stroke (ischaemic or haemorrhagic) confirmed on Computed Tomography or\r\n             Magnetic Resonance imaging\r\n\r\n          2. Aged 21 - 80 years\r\n\r\n          3. Stroke duration of >3 months in outpatient phase (subacute -chronic stroke)\r\n\r\n          4. Able to walk overground at a self-selected speed of >0.2m/s with or without walking\r\n             aids or lower limb orthoses for at least 150 meters with contact guard or supervision.\r\n\r\n          5. Functional ambulation category (FAC >/= 2) (Holden et al 1994)\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Cardiovascular conditions such as uncontrolled hypertension/hypotension, angina\r\n             pectoris, recent myocardial infarction, congestive cardiac failure, known\r\n             echocardiographic ejection fraction < 40% within 3 months of stroke, chronic\r\n             arrhythmias (e.g. atrial fibrillation) within 3 months of study screening, pacemaker,\r\n             uncontrolled Diabetes Mellitus.\r\n\r\n          2. End stage illness (advanced malignancy), pregnancy or end stage renal failure with\r\n             life expectancy of <6 months.\r\n\r\n          3. Aphasia (inability to obey 2 step commands), communication disorder precluding\r\n             understanding of instructions, cognitive impairment, dementia, untreated depression or\r\n             psychiatric disorder.\r\n\r\n          4. Active lower limb arthritis, Pain (Visual Analogue Scale) >5/10, fixed orthopaedic\r\n             deformities of the lower limb which would compromise safe ambulation on treadmill.\r\n\r\n          5. Moderate to severe lower limb spasticity or spasms (Modified Ashworth Scale >2)\r\n\r\n          6. Active trunk skin conditions, known abdominal aortic aneurysm, anticoagulation with\r\n             warfarin precluding safe fit of gait harness\r\n      ","sponsor":"Tan Tock Seng Hospital","sponsor_type":"Other","conditions":"Stroke|Hemiplegic Gait","interventions":[{"intervention_type":"Device","name":"Device: Variable Speed and Sensing Treadmill","description":"open label study on variable speed and sending treadmill training for hemiplegic gait training."}],"outcomes":[{"outcome_type":"primary","measure":"6 Minute Walk Test (Metres)","time_frame":"8 weeks","description":"6 minute walk test - assess distance walked within 6 minutes as a sub maximal test of endurance (Assessed at weeks 0,2,4 and 8)"},{"outcome_type":"primary","measure":"10 Meter Walk Test","time_frame":"8 weeks","description":"Assess time taken to walk 10meters to estimate walking speed(m/s) (Assessed at weeks 0,2,4,8)"}]}
{"nct_id":"NCT01740102","start_date":"2012-08-31","phase":"N/A","enrollment":92,"brief_title":"Clinical Value of Remote Ischemic Preconditioning","official_title":"Does Remote Ischemic Preconditioning Reduce the Incidence of Postoperative Atrial Fibrillation in Patient Undergoing Coronary Artery Bypass Graft Surgery?","primary_completion_date":"2013-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-09-30","last_update":"2016-08-04","description":"Objectives: Despite utilization of available means for cardioprotection during cardiac surgery, myocardial injury still occurs. Further improvement of cardioprotection is therefore necessary. Remote ischemic preconditioning (RIPC) is an easy and non-invasive method. Laboratory research has shown promising results regarding myocardial survival during open heart surgery, but the clinical value of RIPC is still largely unknown. The investigators hypothesize that RIPC before coronary artery bypass grafting (CABG) reduces the incidence of postoperative atrial fibrillation (POAF).","other_id":"2011/2525","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Elective isolated on-pump CABG surgery\r\n\r\n          -  Informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with a severe pulmonary disease\r\n\r\n          -  Patients with renal failure (GFR<30 mL/min/1.73 m2)\r\n\r\n          -  Patients with liver failure\r\n\r\n          -  Peripheral vascular disease affecting the upper limbs\r\n\r\n          -  Patients on sulfonylurea derivatives.\r\n\r\n          -  Patients with atrial fibrillation in their case history\r\n\r\n          -  Prior cardiac surgery (Re-operations)\r\n      ","sponsor":"Norwegian University of Science and Technology","sponsor_type":"Other","conditions":"Heart Diseases|Atrial Fibrillation","interventions":[{"intervention_type":"Procedure","name":"Procedure: RIPC","description":"The remote ischemic preconditioning will consist of three sequential sphygmomanometer cuff inflations. The cuff will be inflated up to 200 mmHg for 5 minutes and then deflated for 5 minutes. This cycle will be performed three times in total. The entire preconditioning will therefore last for 25 minutes."}],"outcomes":[{"outcome_type":"primary","measure":"Postoperative atrial fibrillation","time_frame":"Up to 10 days after surgery","description":"A patient will be classified as belonging to the postoperative atrial fibrillation group if they have any episode of atrial fibrillation, measured by telemetry, lasting more than 1 minute during their postoperative days at the hospital."},{"outcome_type":"secondary","measure":"Length of hospital stay","time_frame":"Maximum 14 days"}]}
{"nct_id":"NCT01433965","start_date":"2012-08-31","phase":"Phase 1","enrollment":16,"brief_title":"Study of Lenalidomide in Patients With Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome","official_title":"Phase I Trial of Maintenance Lenalidomide in Patients With Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome Post Allogeneic Bone Marrow Transplantation","primary_completion_date":"2020-07-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2020-12-31","last_update":"2020-05-28","description":"The purpose of this study is to determine whether lenalidomide can stop the growth of leukemia stem cells and can be used to prevent the return of leukemia cells after a transplant.","other_id":"230510","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Understand and voluntarily sign an informed consent form\r\n\r\n          -  Age greater than or equal to 18 and less than or equal to 65 years\r\n\r\n          -  Able to adhere to the study visit schedule and other protocol requirements.\r\n\r\n          -  High risk acute myelogenous leukemia or high risk myelodysplastic syndrome status post\r\n             allogeneic bone marrow transplant\r\n\r\n          -  ECOG performance status of less than or equal to 2\r\n\r\n          -  Disease free of other malignancies beside the AML or MDS for  2 years with exception\r\n             of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma \"in\r\n             situ\" of the cervix or breast.\r\n\r\n          -  All study participants must be registered into the mandatory RevAssist program, and\r\n             be willing and able to comply with the requirements of RevAssist.\r\n\r\n          -  Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy\r\n             test with a sensitivity of at least 50 mIU/mL within 10 - 14 days and again within 24\r\n             hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled\r\n             within 7 days as required by RevAssist) and must either commit to continued abstinence\r\n             from heterosexual intercourse or begin TWO acceptable methods of birth control, one\r\n             highly effective method and one additional effective method AT THE SAME TIME, at least\r\n             28 days before she starts taking lenalidomide. FCBP must also agree to ongoing\r\n             pregnancy testing. Men must agree to use a latex condom during sexual contact with a\r\n             FCBP even if they have had a successful vasectomy.\r\n\r\n          -  Between 6 months to 8 months post transplant\r\n\r\n          -  Laboratory tests:\r\n\r\n          -  Neutrophil count of  1.5 x 109/L\r\n\r\n          -  Platelet count  50 x 109/L\r\n\r\n          -  Calculated creatinine clearance  60ml/min by Cockcroft-Gault formula\r\n\r\n          -  Total bilirubin 1.5 x upper limit of normal\r\n\r\n          -  AST (SGOT) and ALT (SGPT)  3 x upper limit of normal\r\n\r\n        Patients are eligible to start on this protocol if they are between 6 months to 10 months\r\n        post transplant.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any serious medical condition, laboratory abnormality, or psychiatric illness that\r\n             would prevent the subject from signing the informed consent form\r\n\r\n          -  Pregnant or breast feeding females (Lactating females must agree not to breast feed\r\n             while taking lenalidomide)\r\n\r\n          -  Any level of acute graft versus host disease\r\n\r\n          -  Active, uncontrolled infection are not eligible for this study\r\n\r\n          -  Any condition, including the presence of laboratory abnormalities, which places the\r\n             subject at unacceptable risk if he/she were to participate in the study or confounds\r\n             the ability to interpret data from the study\r\n\r\n          -  Use of any other experimental drug or therapy within 28 days of baseline.\r\n\r\n          -  Known hypersensitivity to thalidomide\r\n\r\n          -  Development of erythema nodosum if characterized by a desquamating rash while taking\r\n             thalidomide or similar drug\r\n\r\n          -  Known sero-positive for active viral infection with HI, hepatitis B virus (HBV) or\r\n             hepatitis C virus (HCV)\r\n\r\n          -  Mixed chimerism (at 6 months post transplant will not be started on the protocol\r\n\r\n          -  Active AML or MDS at the time of the study are not eligible for this protocol\r\n\r\n          -  Not able to swallow the lenalidomide capsule as a whole are excluded from this study\r\n\r\n          -  Impaired gastrointestinal absorption\r\n      ","sponsor":"University of California, Davis","sponsor_type":"Other","conditions":"Acute Myeloid Leukemia|Myelodysplastic Syndrome","interventions":[{"intervention_type":"Drug","name":"Drug: Lenalidomide","description":"Lenalidomide will be taken orally once a day for 21 days continuously in 28 day cycles. The dose of the lenalidomide administered to each patient will be based on the group that the patient is enrolled. The dose cycles will be 21 days of a 28 day cycle."}],"outcomes":[{"outcome_type":"primary","measure":"Maximum-tolerated dose as assessed by NCI CTCAE, Version 4.0 and Graft versus Host Disease Staging","time_frame":"4 week cycle; the expected time frame is 24 weeks (or 6 cycles)","description":"All patients will be followed closely and evaluated for toxicity. For grade III-IV non hematological toxicity or grade IV hematological toxicity associated with lenalidomide will be held until the toxicity resolves and then will be started at a lower dose; Patients who develop grade II to IV GVHD on study will stop lenalidomide"},{"outcome_type":"secondary","measure":"Disease relapse","time_frame":"One year","description":"Percentage of patients with relapse from all the patients who received the transplant."},{"outcome_type":"secondary","measure":"Disease-free survival","time_frame":"One year","description":"Percentage of patients who are alive and remain in remission at one year after infusion of stem cells"},{"outcome_type":"secondary","measure":"Incidence of Graft versus Host disease","time_frame":"One year","description":"The percentage of pathologically confirmed cases of acute and/or chronic Graft versus Host disease at one year post transplant"}]}
{"nct_id":"NCT01686165","start_date":"2012-08-31","phase":"Phase 2","enrollment":5,"brief_title":"Belinostat and Yttrium Y 90 Ibritumomab Tiuxetan in Patients W/Relapsed Aggressive B-Cell NHL","official_title":"A Phase II Exploratory Study of PXD-101(Belinostat) Followed by Zevalin in Patients With Relapsed Aggressive High-Risk Lymphoma","primary_completion_date":"2016-02-09","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-11-09","last_update":"2018-08-28","description":"This study looks at what effects (good and bad) a drug called PXD-101 (belinostat) in combination with the radioactive drug Zevalin (yttrium Y 90 ibritumomab tiuxetan) has on patients with relapsed aggressive (high-risk) non-Hodgkin lymphoma. Studies in the laboratory suggest that drugs such as PXD101 can act upon specific cancer cell processes to cause either death of the cancer cells or prevention of their growth. In human studies with a small number of patients with this lymphoma, PXD-101 has shown the ability to shrink and slow tumor growth. When Zevalin is delivered directly to the tumor, the lymphoma cells are destroyed and this may result in the disappearance of the tumor (remission)","other_id":"12-0288-04","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Biopsy confirmed, CD20 positive diffuse large B-cell lymphoma, primary mediastinal\r\n             b-cell lymphoma, mantel cell lymphoma, transformed indolent lymphoma, high\r\n             grade-B-cell lymphoma; AND bone marrow must show =< 20% CD20+ B-cells with >= 15%\r\n             cellularity within 42 days of study registration\r\n\r\n          -  Any stage disease\r\n\r\n          -  Patients must have been previously treated:\r\n\r\n               -  >= 3rd line if bone marrow transplant (BMT) candidate OR\r\n\r\n               -  >= 2nd line if not BMT candidate OR\r\n\r\n               -  >= 2nd relapse for BMT candidate OR\r\n\r\n               -  >= 1st relapse for non- BMT candidate\r\n\r\n          -  Must have a diagnostic quality CT scan of the chest, abdomen and pelvis OR baseline\r\n             PET-CT scan performed within 28 days prior to registration\r\n\r\n          -  Must have bidimensionally measurable disease with lesions at least 1.5 cm in one\r\n             dimension ALL measurable disease must be assessed within 28 days of registration\r\n\r\n          -  To determine prior drug regimens: radiation therapy counts as 1 treatment, BMT\r\n             including induction counts as one treatment, radioimmunotherapy is not considered a\r\n             chemotherapy regimen, rituximab alone is not considered a treatment; all prior therapy\r\n             must have been completed at least 30 days prior to registration; patients should not\r\n             have taken valproic acid, or any other histone deacetylase inhibitor (eg., vorinostat,\r\n             romidepsin), for at least 30 days prior to registration; patients must have recovered\r\n             from any toxicities related to therapies prior to registration\r\n\r\n          -  No clinical evidence of CNS involvement by lymphoma, any lab (eg., LDH or radiographic\r\n             tests performed to access CNS involvement must be negative and must be performed\r\n             within 42 days prior to registration\r\n\r\n          -  Unilateral or bilateral bone marrow biopsy performed within 42 days prior to\r\n             registration\r\n\r\n          -  Life expectancy of greater than 3 months\r\n\r\n          -  Karnofsky performance status >= 60%\r\n\r\n          -  Leukocytes >= 3,000/mcL\r\n\r\n          -  Absolute neutrophil count >= 1,500/mcL\r\n\r\n          -  Platelets >= 100,000/mcL\r\n\r\n          -  AST (SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal\r\n\r\n          -  Total bilirubin =< 1.5 X institutional upper limit of normal (unless associated with\r\n             Gilbert's syndrome)\r\n\r\n          -  Serum creatinine < 2 x institutional upper limit of normal OR\r\n\r\n          -  Measured creatinine clearance >= 60 mL/min\r\n\r\n          -  LDH < 1.50 X institutional upper limit of normal\r\n\r\n          -  EKG with no significant abnormalities within 28 days prior to registration\r\n\r\n          -  Women of child-bearing potential and men must agree to use adequate contraception\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who have had chemotherapy or radiotherapy within 30 days (6 weeks for\r\n             nitrosoureas or mitomycin C) prior to study screening or those who have not recovered\r\n             from adverse events due to agents administered more than 4 weeks earlier\r\n\r\n          -  Prior radioimmunotherapy\r\n\r\n          -  Pregnant or nursing\r\n\r\n          -  Clinical evidence of CNS involvement by lymphoma\r\n\r\n          -  History of allergic reactions attributed to compounds of similar chemical or biologic\r\n             composition to PXD-101 or Zevalin or other agents used in the study\r\n\r\n          -  Concomitant medication that may cause Torsade de Pointes, i.e. prolongation of the QT\r\n             interval > 500 msec\r\n\r\n          -  Significant cardiovascular disease including unstable angina pectoris, uncontrolled\r\n             hypertension, congestive heart failure related to primary cardiac disease, any\r\n             condition requiring anti-arrhythmic therapy, ischemic or valvular heart disease, or a\r\n             myocardial infarction within the past 6 months\r\n\r\n          -  Current long QT syndrome or baseline prolongation of QT/QTcF interval, i.e.\r\n             demonstration of a QTcF interval > 450 msec\r\n\r\n          -  Clinical evidence of severe peripheral vascular disease, diabetic ulcers or venous\r\n             stasis ulcers, or history of deep venous or arterial thrombosis within 3 months prior\r\n             to screening\r\n\r\n          -  Known to be human immunodeficiency virus (HIV) positive or with known acquired\r\n             immunodeficiency syndrome (AIDS) syndrome\r\n\r\n          -  Patients may not be receiving any other investigational agents\r\n      ","sponsor":"University of Arizona","sponsor_type":"Other","conditions":"Anaplastic Large Cell Lymphoma|Recurrent Adult Diffuse Large Cell Lymphoma|Recurrent Mantle Cell Lymphoma","interventions":[{"intervention_type":"Drug","name":"Drug: belinostat","description":"Given IV"},{"intervention_type":"Biological","name":"Biological: rituximab","description":"Given IV"},{"intervention_type":"Radiation","name":"Radiation: yttrium Y 90 ibritumomab tiuxetan","description":"Given IV"}],"outcomes":[{"outcome_type":"primary","measure":"Complete Response Rate","time_frame":"Up to 5 years","description":"To document the complete response rate for patients with relapsed aggressive high-risk non-Hodgkin's lymphoma (NHL) treated with two cycles PXD-101 followed by one cycle of the Zevalin regimen."},{"outcome_type":"primary","measure":"Overall Response","time_frame":"Up to 5 years","description":"To document the overall response for patients with relapsed aggressive high-risk non-Hodgkin's lymphoma (NHL) treated with two cycles PXD-101 followed by one cycle of the Zevalin regimen."},{"outcome_type":"secondary","measure":"Progression-free Survival","time_frame":"2 years","description":"Will be estimated using a Kaplan-Meier estimate. The observed 2-year progression-free survival rate will be estimated (with a 95% confidence interval) from the Kaplan-Meier curve."},{"outcome_type":"secondary","measure":"Occurrence of Adverse Events and Serious Adverse Events","time_frame":"Up to 30 days after patient receives last dose of study drug","description":"The proportion of patients with a given adverse event will be tabulated and the 95% confidence interval computed."}]}
{"nct_id":"NCT01782508","start_date":"2012-08-31","phase":"Phase 2","enrollment":40,"brief_title":"A Phase II Study of Imatinib Versus Interferon as Adjuvant Therapy in KIT-mutated Melanoma","official_title":"A Phase II Randomized Study of Imatinib Versus High Dose Interferon as Adjuvant Therapy in KIT-mutated Patients With Resected Melanoma","primary_completion_date":"2013-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2014-12-31","last_update":"2013-02-04","description":"The purpose of this study is to compare the relapse free survival and overall survival of Imatinib (Gleevec) or high dose Interferon (Intron) in treating melanoma which has primary tumor and regional lymphonode (if have) removed in patients whose disease carries a c-kit mutation. It is assumed that Gleevec may be more effective on relapse free survival as the adjuvant treatment compared with Interferon.","other_id":"AMN107A2301","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Melanoma patients whose primary tumor and regional lymphonodes (if have)have been\r\n             resected\r\n\r\n          -  Histologically documented AJCC stage IIB to IIIC\r\n\r\n          -  C-kit mutation documented from either primary or metastatic lymphnode site\r\n\r\n          -  ECOG performance status 0 or 1\r\n\r\n          -  Age 18 years or older\r\n\r\n          -  Creatinine < 1.5 x ULN\r\n\r\n          -  ANC > 1500 ul\r\n\r\n          -  Platelets > 100,000 ul\r\n\r\n          -  Total bilirubin, AST, and ALT < 2 x ULN\r\n\r\n          -  Amylase and lipase < 1.5 x ULN\r\n\r\n          -  no prior chemotherapy or investigational drug\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Severe and/or uncontrolled medical disease\r\n\r\n          -  Pregnant or nursing mothers\r\n\r\n          -  Any other significant medical, surgical, or psychiatric condition that may interfere\r\n             with compliance\r\n\r\n          -  Patient is < 5 years free of another primary malignancy except: basal cell skin cancer\r\n             or a cervical carcinoma in situ\r\n\r\n          -  Concurrent treatment with Warfarin\r\n\r\n          -  Prior treatment with c-kit inhibitor\r\n\r\n          -  Patient with Grade III/IV cardiac problems as defined by NYHA criteria\r\n\r\n          -  No H2 blockers or proton pump inhibitors\r\n\r\n          -  Known chronic liver disease\r\n\r\n          -  Known diagnosis of HIV infection\r\n\r\n          -  Major surgery within 2 weeks prior to study entry\r\n\r\n          -  Patient has received any other investigational agent within 28 days of first study\r\n             drug dosing\r\n\r\n          -  Chemotherapy within 4 weeks prior to study entry\r\n      ","sponsor":"Beijing Cancer Hospital","sponsor_type":"Other","conditions":"Melanoma","interventions":[{"intervention_type":"Drug","name":"Drug: imatinib","description":"a selectively inhibits the KIT protein tyrosine"},{"intervention_type":"Drug","name":"Drug: Interferon","description":"Interferon belongs to the large class of glycoproteins known as cytokines."}],"outcomes":[{"outcome_type":"primary","measure":"relapse free survival","time_frame":"participants will be followed for the duration of hospital stay, an expected average of 18 months"},{"outcome_type":"secondary","measure":"overall survival","time_frame":"From date of randomization until the date of death from any cause, assessed up to 48 months"}]}
{"nct_id":"NCT01544491","start_date":"2012-08-17","phase":"Phase 3","enrollment":106,"brief_title":"Efficacy, Tolerability and Safety of Early Introduction of Everolimus, Reduced Calcineurin Inhibitors and Early Steroid Elimination Compared to Standard CNI, Mycophenolate Mofetil and Steroid Regimen in Paediatric Renal Transplant Recipients","official_title":"A 12-month, Multicenter, Open Label, Randomized, Controlled Study to Evaluate the Efficacy, Tolerability and Safety of Early Introduction of Everolimus, Reduced CNI, and Early Steroid Elimination Compared to Standard CNI, Mycophenolate Mofetil and Steroid Regimen in Paediatric Renal Transplant Recipients With a 24-month Additional Safety Follow-up.","primary_completion_date":"2016-10-03","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-09-24","last_update":"2019-05-31","description":"The purpose of this study is to determine if everolimus combined with reduced exposure CNI (TAC) is efficacious and safe and will support corticosteroid elimination compared to a standard exposure CNI (TAC) + MMF + steroid regimen after paediatric kidney transplantation. An additional purpose of the study is to assess the effect of the combination of EVR and reduced exposure CNI (TAC) on renal function. This study is part of the requirements of the Paediatric Investigational Plan approved by Paediatric Committee at the European Medicines Agency (PDCO/EMA) on September 10, 2010, and is intended to support the indication of everolimus in the prevention of acute rejection in paediatric recipients of a renal transplant.","other_id":"CRAD001A2314","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":1,"maximum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Inclusion criteria at baseline:\r\n\r\n          1. Written informed consent/assent must be obtained from the parent(s) or legal guardian\r\n             before any assessment is performed.\r\n\r\n          2. Primary or secondary paediatric kidney transplant recipient aged greater than or equal\r\n             to 1 year and younger than 18 years receiving a deceased donor or non-HLA identical\r\n             living donor (related or unrelated) renal transplant.\r\n\r\n        Inclusion criteria at randomization:\r\n\r\n          1. Patients on TAC + MMF + steroids.\r\n\r\n          2. Renal function with eGFR > 40 ml/min/1.73 m2 (Schwartz formula - abbreviated).\r\n\r\n        Exclusion Criteria:\r\n\r\n        Exclusion criteria at baseline:\r\n\r\n          1. Recipients of kidneys from donors with known renal disease (such as diabetes\r\n             nephropathy, nephrosclerosis), at the time of transplant.\r\n\r\n          2. Recipients of a kidney with a cold ischemia time > 24 hours.\r\n\r\n          3. History of hypersensitivity or contraindications to any of the study drugs or to drugs\r\n             of similar chemical classes, or to any of the excipients.\r\n\r\n          4. History of malignancy of any organ system treated or untreated, carrying possible risk\r\n             of recurrence according to current guidelines (Appendix 10 of protocol).\r\n\r\n        Exclusion criteria at randomization:\r\n\r\n          1. Use of other investigational drugs at the time of randomization, or within 30 days or\r\n             5 half-lives prior randomization, whichever is longer.\r\n\r\n          2. Patients with ongoing or recently (within 2 weeks prior to randomization) treated\r\n             episodes of acute rejection (any grade) or a steroid resistant acute rejection at the\r\n             time of randomization.\r\n\r\n          3. Patients who experienced acute cellular rejection (Banff 1B) or any antibody mediated\r\n             acute rejection or patients considered at high risk of antibody mediated acute\r\n             rejection by the investigator assessment (e.g. presence of newly formed DSA,\r\n             histological suspicion) at any time before randomization (as the DSA quantitative\r\n             threshold to define high risk is not fully established, the assessment of the risk\r\n             will be made after discussion between the laboratory expert and the investigator who\r\n             will take into account all information available and apply best judgment).\r\n\r\n          4. Patients with ongoing wound healing problems, clinically significant wound infection\r\n             requiring continued therapy or other severe surgical complication in the opinion of\r\n             the investigator.\r\n\r\n          5. Patients who are treated with drugs that are strong inducers or inhibitors of\r\n             cytochrome P450 3A4 (CYP3A4) and can not discontinue the treatment (see Appendix 6 for\r\n             list of medications).\r\n\r\n          6. Patients with nephrotic range proteinuria (protein to creatinine ratio 2.0 mg/mg or\r\n             200 mg/mmol (Hogg, 2003).\r\n      ","sponsor":"Novartis Pharmaceuticals","sponsor_type":"Industry","conditions":"Prevention of Acute Rejection in Paediatric Recipients of a Renal Transplant","interventions":[{"intervention_type":"Drug","name":"Drug: RAD001","description":"Everolimus (C0 trough level of 3-8 ng/mL) in combination with reduced dose tacrolimus and steroids withdrawal at 6 months after transplant"},{"intervention_type":"Drug","name":"Drug: MMF","description":"MMF (Cellcept): 600mg/m2/dose twice daily (1200 mg/m2/day) in combination with tacrolimus (Prograf) and standard dose steroids"}],"outcomes":[{"outcome_type":"secondary","measure":"Proteinuria (Urinary Protein/Creatinine Ratio)","time_frame":"at 12 and 36 months post-transplantation","description":"The urinary protein/creatinine ratio will be descriptively summarized by treatment group at each visit. The incidence rate of patients with proteinuria will be categorized in <0.2 g/mg/mg, 0.2<2.0 mg/mg and ≥ 2.0 mg/mg and summarized by treatment groups at each visit."},{"outcome_type":"primary","measure":"Number of Participants Having Reached the Composite Efficacy Endpoint of Biopsy-proven Acute Rejection","time_frame":"12 months, 36 months","description":"To estimate the rate of the composite efficacy endpoint of biopsy-proven acute rejection (BPAR), graft loss or death at 12 months post transplantation in primary paediatric kidney transplant recipients converted at 4-6 weeks post-transplantation from MMF + standard TAC regimen and steroids, to everolimus + reduced dose TAC regimen and steroid withdrawal at 6 months, versus continuation of MMF + standard TAC regimen and steroids."},{"outcome_type":"primary","measure":"To Evaluate Renal Function, Assessed by Glomerular Filtration Rate (eGFR) and Estimated by the Schwartz Formula (Abbreviated), at Month 12 and 36","time_frame":"12 months and 36 months post-transplantation","description":"To evaluate renal function assessed by Glomerular Filtration Rate (eGFR) estimated by the Schwartz Formula (abbreviated) (Schwartz, 2009)."},{"outcome_type":"secondary","measure":"Composite Efficacy Endpoint","time_frame":"at 12 and 36 months post-transplantation","description":"To evaluate the proportion of patients with the following efficacy events: Biopsy Proven Acute Rejection (BPAR), graft loss or death. The efficacy events will be descriptively summarized by treatment group."},{"outcome_type":"secondary","measure":"To Evaluate the Severity of BPAR (Acute T-cell Mediated Rejection Only) (Banff 2009)","time_frame":"month 12, month 36","description":"T-cell mediated rejection severity :\r\nType IA - Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells).\r\nType IB - Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells).\r\nType IIA - Mild to moderate intimal arteritis Type IIB - Severe intimal arteritis comprising > 25% of the lumenal area Type III - Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation)"},{"outcome_type":"secondary","measure":"To Evaluate the Time to Event of BPAR","time_frame":"36 months","description":"Time to incidence of Event, given in terms of number of participants with an Event according to time interval up to 36 months"},{"outcome_type":"secondary","measure":"Incidence of Biopsy Proven Antibody Mediated Rejection.","time_frame":"at 12 and 36 months post-transplantation","description":"To evaluate the proportion of patients with the following efficacy events: biopsy proven antibody mediated rejection/Steroid resistant BPAR and BPAR treated with T cell depleting therapy."},{"outcome_type":"secondary","measure":"Chronic Allograft Nephropathy / Interstitial Fibrosis and Tubular Atrophy","time_frame":"at 12 and 36 months post-transplantation.","description":"To evaluate the proportion of patients with chronic allograft nephropathy (interstitial fibrosis and tubular atrophy, IF/TA) by histopathology and its progression.The term chronic allograft nephropathy was used inappropriately in the protocol and therefore, replaced by interstitial fibrosis and tubular atrophy"},{"outcome_type":"secondary","measure":"Growth/Development : Weight, Height, BMI : Change From Baseline","time_frame":"month 12 , month 36 post transplantation.","description":"Evaluation of the potential effects upon the bone growth. The Z-score is a statistical tool which helps to assess data (here child growth parameters) relative to a reference or standard population. The Z-score describes the distance and direction of an observation away from the population median (or mean, however, here the median was used). A negative Z-score shows that data are lower than the median of the standard population, a positive Z-score shows that data are higher than the median of the standard population, and a Z-score of zero shows that the data are equal to the median of the standard population. The more the Z-score is distant from 0, the more expressed is for example underweight or overweight."},{"outcome_type":"secondary","measure":"Evaluation of Evolution of Renal Allograft Function Over Time","time_frame":"baseline, 6 months, 12 months , 24 months, 36 months","description":"results given as eGFR values by time interval"},{"outcome_type":"secondary","measure":"To Evaluate Renal Function, Assessed by Glomerular Filtration Rate (eGFR) and Estimated by the Schwartz Formula (Extended), at Month 12","time_frame":"12 months post-transplantation","description":"To evaluate renal function assessed by Glomerular Filtration Rate (eGFR) estimated by the Schwartz Formula (extended) (Schwartz, 2009). Results given as change from randomization"}]}
{"nct_id":"NCT01648582","start_date":"2012-07-31","phase":"Phase 3","enrollment":774,"brief_title":"A Study Comparing the Effects and Safety of Dulaglutide With Insulin Glargine in Type 2 Diabetes Mellitus","official_title":"The Efficacy and Safety of Once-Weekly, Subcutaneous Dulaglutide Compared to Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Mellitus on Metformin and/or a Sulfonylurea","primary_completion_date":"2014-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-12-31","last_update":"2019-09-18","description":"The purpose of this study is to examine if once-weekly dulaglutide is efficient and safe compared to once-daily insulin glargine in participants with type 2 diabetes mellitus who have inadequate glycemic control with 1 or 2 oral antihyperglycemic medications (OAM) (metformin and/or a sulfonylurea), in addition to any healthy lifestyle changes recommended by their healthcare providers.","other_id":"13439","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Have type 2 diabetes mellitus for at least 6 months\r\n\r\n          -  Have been taking metformin and/or a sulfonylurea for at least 3 months before\r\n             screening and have been on a stable therapeutic dose for at least 8 weeks\r\n\r\n          -  Glycosylated hemoglobin (HbA1c) value of 7.0% to 11.0%\r\n\r\n          -  Adult men or adult non-pregnant, non-breastfeeding women\r\n\r\n          -  Body Mass Index (BMI) of 19.0 to 35.0 kilograms/square meter (kg/m^2)\r\n\r\n          -  Stable weight (5%) 3 months prior to screening\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Have type 1 diabetes mellitus\r\n\r\n          -  Have previous treatment with a glucagon-like peptide-1 (GLP-1) receptor agonist, GLP-1\r\n             analog, or any other incretin mimetic\r\n\r\n          -  Have treatment with dipeptidyl peptidase-IV (DPP-IV) inhibitor, an alpha-glucosidase\r\n             inhibitor (AGI), thiazolidinedione (TZD), or glinide\r\n\r\n          -  Have gastric emptying abnormality\r\n\r\n          -  Have cardiac disorder defined as unstable angina, myocardial infarction, coronary\r\n             artery bypass graft surgery, percutaneous coronary intervention, heart failure,\r\n             arrhythmia, transient ischemic attack, or stroke\r\n\r\n          -  Have poorly controlled hypertension (systolic blood pressure above 160 millimeter of\r\n             mercury[mmHg] or diastolic blood pressure above 95 mmHg)\r\n\r\n          -  Have impaired liver function\r\n\r\n          -  Have impaired kidney function\r\n\r\n          -  Have history of chronic pancreatitis or acute pancreatitis\r\n\r\n          -  Have a serum calcitonin 20 picograms per milliliter (pg/mL)\r\n\r\n          -  Have a personal or family history of medullary C-cell hyperplasia, focal hyperplasia,\r\n             carcinoma, or multiple endocrine neoplasia type 2 (MEN 2)\r\n      ","sponsor":"Eli Lilly and Company","sponsor_type":"Industry","conditions":"Type 2 Diabetes Mellitus","interventions":[{"intervention_type":"Drug","name":"Drug: Dulaglutide","description":"Administered SC"},{"intervention_type":"Drug","name":"Drug: Insulin glargine","description":"Administered SC per dosing titration schedule"},{"intervention_type":"Drug","name":"Drug: Metformin","description":"Administered orally at pre-study prescribed dose, and is not being provided as part of the trial."},{"intervention_type":"Drug","name":"Drug: Sulfonylureas","description":"Administered orally at pre-study prescribed dose, and is not being provided as part of the trial."}],"outcomes":[{"outcome_type":"secondary","measure":"Change From Baseline in HbA1c at 52 Weeks","time_frame":"Baseline, 52 Weeks","description":"HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS means of change from baseline in HbA1c were calculated using a MMRM with the change in HbA1c as the dependent variable and treatment, baseline HbA1c, country, OAM, visit, and treatment-by-visit interaction as fixed effects, and participant was as the random effect."},{"outcome_type":"primary","measure":"Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks","time_frame":"Baseline, 26 Weeks","description":"HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) means of change from baseline in HbA1c were calculated using a mixed-effects model for repeated measures (MMRM) with the change in HbA1c as the dependent variable and treatment, baseline HbA1c, country, oral antihyperglycemic medication (OAM) , visit, and treatment-by-visit interaction as fixed effects, and participant was the random effect."},{"outcome_type":"secondary","measure":"Change From Baseline in Body Weight","time_frame":"Baseline, 26 Weeks, 52 Weeks"},{"outcome_type":"secondary","measure":"Change in Body Mass Index","time_frame":"Baseline, 26 Weeks, 52 Weeks","description":"Body mass index is an estimate of body fat based on body weight divided by height squared."},{"outcome_type":"secondary","measure":"Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks and 52 Weeks","time_frame":"Up to 26 and 52 weeks","description":"The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100."},{"outcome_type":"secondary","measure":"Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks and 52 Weeks","time_frame":"Baseline, 26 Weeks, 52 Weeks","description":"LS means of change from baseline were calculated using MMRM with the change in FBG as the dependent variable and treatment, baseline value, country, OAM, visit, and treatment-by-visit interaction as fixed effects, and participant was the random effect."},{"outcome_type":"secondary","measure":"Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks and 52 Weeks","time_frame":"Baseline, 26 Weeks, 52 Weeks","description":"Participants were required to perform 7-point SMBG profiles on 2 separate, nonconsecutive days during the 2 weeks before randomization and Weeks 8, 14, 20, 26, 39, and 52 (or the Early Discontinuation Visit). SMBG measurements were taken using a plasma-equivalent blood glucose (BG) meter at 7 time points: morning pre-meal, morning 2 hours post-meal, mid-day pre-meal, mid-day 2 hours post-meal, evening pre-meal, evening 2 hours post-meal, and at bedtime. Mean and Week 26 and Week 52 was assessed in all treatment groups. LS means of change from baseline were calculated using MMRM with the change in 7-point SMBG as the dependent variable and treatment, baseline value, country, OAM, visit, and treatment-by-visit interaction as fixed effects, and participant was the random effect."},{"outcome_type":"secondary","measure":"Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β)- Cell Function (HOMA2-%B) at 26 Weeks and 52 Weeks","time_frame":"Baseline, 26 weeks, 52 weeks","description":"The updated Homeostasis Model Assessment (HOMA2) was used to quantify steady state beta-cell function (%B). HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate %B as a percentage of a normal reference population. LS means were calculated using a homeostasis model assessment with change from baseline in HOMA-%B as a covariate and country, baseline measurement, OAM, and treatment as fixed effects."},{"outcome_type":"secondary","measure":"Change From Baseline in Homeostasis Model Assessment 2 Insulin Sensitivity - Cell Function (HOMA2-%S) at 26 Weeks and 52 Weeks","time_frame":"Baseline, 26 Weeks, 52 Weeks","description":"The HOMA2 was used to estimate the steady-state insulin sensitivity (%S). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as a percentage of the normal reference population. LS means were calculated using an homeostasis model assessment with change from baseline in HOMA-%S as a covariate and country, baseline measurement, OAM, and treatment as fixed effects."},{"outcome_type":"secondary","measure":"Rate of Hypoglycemic Events","time_frame":"Baseline through 26 weeks and 52 weeks","description":"Hypoglycemic events (HE) were classified as documented symptomatic hypoglycemia, asymptomatic hypoglycemia, severe hypoglycemia, and probable symptomatic hypoglycemia. The 1-year adjusted rate of HEs was summarized cumulatively at 26 weeks and 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module."},{"outcome_type":"secondary","measure":"Number of Self-reported Hypoglycemic Events","time_frame":"Baseline through 26 Weeks and 52 Weeks","description":"Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia, and had a plasma glucose level of less than or equal to 3.9 millimoles/liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of self-reported hypoglycemic events was summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module."},{"outcome_type":"secondary","measure":"Change From Baseline to 26 Weeks and 52 Weeks on Blood Pressure (BP)","time_frame":"Baseline, 26 Weeks, 52 Weeks","description":"Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured. LS means of change from baseline were calculated using a MMRM with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate."},{"outcome_type":"secondary","measure":"Change From Baseline at 26 Weeks and 52 Weeks on Pulse Rate","time_frame":"Baseline, 26 Weeks, 52 Weeks","description":"Seated pulse rate was measured. LS means of change from baseline were calculated using a MMRM with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate."},{"outcome_type":"secondary","measure":"Change From Baseline in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval","time_frame":"Baseline, 26 Weeks, 52 Weeks","description":"The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex."},{"outcome_type":"secondary","measure":"Change From Baseline in Electrocardiogram Parameters, Heart Rate (HR)","time_frame":"Baseline, 26 Weeks, 52 Weeks"},{"outcome_type":"secondary","measure":"Change From Baseline in Pancreatic Enzymes","time_frame":"Baseline, 26 Weeks, 52 Weeks","description":"Amylase (total and pancreas-derived) and lipase concentrations were measured"},{"outcome_type":"secondary","measure":"Change From Baseline in Serum Calcitonin","time_frame":"Baseline, 26 Weeks, 52 Weeks"},{"outcome_type":"secondary","measure":"Number of Participants With Adjudicated Cardiovascular (CV) Events","time_frame":"Baseline through 52 weeks","description":"Deaths and nonfatal cardiovascular adverse events were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular events subjected to adjudication included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module."},{"outcome_type":"secondary","measure":"Number of Participants With Adjudicated Pancreatitis","time_frame":"Baseline through 52 Weeks","description":"The number of participants with pancreatitis confirmed by adjudication is summarized. Events of pancreatitis (including suspected pancreatitis and severe or serious abdominal pain) were adjudicated by a committee of expert physicians external to the Sponsor. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module."},{"outcome_type":"secondary","measure":"Percentages of Participants Developing Treatment-Emergent Dulaglutide Anti-drug Antibody (ADA)","time_frame":"Baseline through 52 Weeks","description":"Number of participants with treatment emergent (TE) dulaglutide anti-drug antibodies from postbaseline to follow up were summarized. A participant was considered to have TE dulaglutide ADA if the participant had at least one titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement."},{"outcome_type":"secondary","measure":"EQ-5D Health State Score Responses","time_frame":"Baseline, 26 Weeks, 52 Weeks","description":"The EQ-5D questionnaire is a widely used, generic questionnaire that assesses health-related quality of life. It consists of 2 parts. The first part assesses 5 dimensions associated with quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 3 possible levels of response: no problem, some problem, and extreme problem. Additional categories of response include ambiguous and missing. The number of participants per each of the 3 response categories is summarized for each of the 5 dimensions."},{"outcome_type":"secondary","measure":"Change From Baseline in EQ-5D Visual Analog Scale Score","time_frame":"Baseline, 26 weeks, 52 weeks","description":"The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. Overall health state score was self-reported using a visual analogue scale (VAS) marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state. LS means of change from baseline were calculated using ANCOVA and adjusted by treatment, country, and baseline."}]}
{"nct_id":"NCT01643681","start_date":"2012-07-31","phase":"N/A","enrollment":0,"brief_title":"Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Lumbar Intervertebral Disc Degeneration","official_title":"Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Lumbar Intervertebral Disc Degeneration","primary_completion_date":"2014-03-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2015-12-31","last_update":"2019-06-05","description":"The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with lumbar intervertebral disc degeneration.","other_id":"KSC-MSCs-LIDD","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":19,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subjects who understand and sign the consent form for this study\r\n\r\n          -  Age :19-70, males and females\r\n\r\n          -  Have chronic low back pain for at least 1 year\r\n\r\n          -  Have failed 1 year of non-operative low back pain management\r\n\r\n          -  Have degenerated intervertebral disc on T2-weighted MR images\r\n\r\n          -  confirmed by positive discography\r\n\r\n          -  Have significant lumbar instability at degenerated intervertebral disc\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Have significant lumbar herniated intervertebral disc\r\n\r\n          -  Women who are pregnant or breast feeding or planning to become pregnant during the\r\n             study\r\n\r\n          -  History or current evidence of alcohol or drug abuse or is a recreational user of\r\n             illicit drugs or prescription medications\r\n\r\n          -  Serious pre-existing medical conditions like Cardiovascular Diseases, Renal Diseases,\r\n             Liver Diseases, Endocrine Diseases, Cancer and Diabetes Mellitus\r\n\r\n          -  Participation in another clinical trial or treatment with a different investigational\r\n             product within 30 days prior to inclusion in the study\r\n\r\n          -  Other pathologic conditions or circumstances that difficult participation in the study\r\n             according to medical criteria\r\n      ","sponsor":"R-Bio","sponsor_type":"Industry","conditions":"Lumbar Intervertebral Disc Degeneration","interventions":[{"intervention_type":"Procedure","name":"Procedure: Autologous Adipose Tissue derived MSCs Transplantation","description":"Into lumbar intervertebral disc infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 4x10e7 cells/1mL"}],"outcomes":[{"outcome_type":"primary","measure":"Magnetic Resonance Imaging","time_frame":"24 weeks","description":"To evaluate the change of treated lumbar intervertebral discs using Magnetic Resonance Imaging (MRI) at 6 months post injection of MSCs."},{"outcome_type":"secondary","measure":"Changes of Neurological Functions","time_frame":"24 weeks","description":"To evaluate the change of treated lumbar intervertebral discs using Muscle Test, Somatosensory Test, Deep Tendon Reflex and VAS (Visual Analogue Scale Score 0-10) at 6 months post injection of MSCs."},{"outcome_type":"secondary","measure":"Safety evaluation","time_frame":"24 weeks","description":"To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using physical examinations, vital signs, treatment emergent adverse events (TEAEs), and the results of clinical lab tests."}]}
{"nct_id":"NCT01840462","start_date":"2012-07-31","enrollment":372,"brief_title":"Longitudinal Study for Treatment With Botulinum Toxin A Injections in nave and Pre-treated Patients Suffering From Cervical Dystonia [CD-NIS-Longterm]","official_title":"A National, Multicenter, Non-interventional, Prospective, Longitudinal Study for Treatment With Botulinum Toxin A Injections in nave and Pre-treated Patients Suffering From Cervical Dystonia (Dysport)","primary_completion_date":"2015-11-30","study_type":"Observational","rec_status":"Completed","completion_date":"2016-03-31","last_update":"2019-01-14","description":"The objective of this study is to investigate the efficacy of Dysport in the treatment of cervical dystonia (CD) in a non-interventional long-term study in nave and pre-treated patients.","other_id":"A-94-52120-165","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients suffering from cervical dystonia","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Suffering from cervical dystonia with rotational torticollis/-caput or\r\n             laterocollis/-caput as the primary component\r\n\r\n          -  Nave to botulinum toxin A or pre-treated with botulinum toxin A on a regular basis\r\n             for at least 2 years prior to inclusion and last injection with Dysport and last\r\n             injection between 3 and 6 months prior to inclusion\r\n\r\n          -  With the intention to be treated with Dysport\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  The subject has already been included in this study\r\n\r\n          -  Participation in an interventional trial\r\n\r\n          -  Suffering from anterocollis or retrocollis as primary component\r\n      ","sponsor":"Ipsen","sponsor_type":"Industry","conditions":"Cervical Dystonia","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Change in Tsui scores","time_frame":"Baseline and 12 weeks post-injection Cycle 2","description":"The Tsui rating scale is a disease-specific score to evaluate the severity of CD taking the clinical signs of CD into account in a standardised manner."},{"outcome_type":"secondary","measure":"Change in Tsui scores","time_frame":"Baseline and 12 weeks post-injection Cycle 1","description":"The Tsui rating scale is a disease-specific score to evaluate the severity of CD taking the clinical signs of CD into account in a standardised manner."},{"outcome_type":"secondary","measure":"Change in Tsui scores","time_frame":"Baseline and 12 weeks post-injection Cycle 3","description":"The Tsui rating scale is a disease-specific score to evaluate the severity of CD taking the clinical signs of CD into account in a standardised manner."},{"outcome_type":"secondary","measure":"Change in Tsui scores","time_frame":"Baseline and 12 weeks post-injection Cycle 4","description":"The Tsui rating scale is a disease-specific score to evaluate the severity of CD taking the clinical signs of CD into account in a standardised manner."}]}
{"nct_id":"NCT01526694","start_date":"2012-07-31","phase":"Phase 2","enrollment":30,"brief_title":"Phase II Trial Designed to Determine Efficacy and Safety of Bendamustine+Dexamethasone+Thalidomide in R/R MM","official_title":"Phase II Multicenter Clinical Trial to Investigate the Efficacy and Safety of Bendamustine, Dexamethasone and Thalidomide in R/R MM Pts After Treatment With Lenalidomide and Bortezomib or Which Are Ineligible to One of These Drugs","primary_completion_date":"2015-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-04-08","last_update":"2018-07-03","description":"This is a prospective, multicenter phase II trial designed to determine efficacy and safety of a combination chemotherapy consisting of Bendamustine + Dexamethasone + Thalidomide in patients with multiple myeloma (MM) after treatment with lenalidomide and bortezomib or which are ineligible to one of these drugs.","other_id":"BDT-01-2011","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Understand and voluntarily sign an informed consent form.\r\n\r\n          -  Age 18 years at the time of signing the informed consent form.\r\n\r\n          -  Life expectancy of at least 3 months\r\n\r\n          -  Able to adhere to the study visit schedule and other protocol requirements\r\n\r\n          -  Relapsed or refractory active MM (according to the International Myeloma Working Group\r\n             guidelines) after treatments containing bortezomib and lenalidomide or ineligible\r\n             (intolerance or toxicity) to one of these drugs with detectable myeloma protein in\r\n             blood or urine.\r\n\r\n          -  Disease free of prior malignancies for at least 5 years.\r\n\r\n          -  All previous multiple myeloma treatments, including radiation, cytostatic therapy and\r\n             surgery, must have been discontinued at least 4 weeks prior to treatment in this\r\n             study, except corticosteroids therapy.\r\n\r\n          -  ECOG performance status <2 at study entry, unless it is due to MM.\r\n\r\n          -  At least the following laboratory findings at the day of treatment start:\r\n\r\n          -  Platelet count  75 x 10^9/L without transfusional support within 7 days.\r\n\r\n          -  Neutrophil count > 1.5 x 10^9/L without G-CSF.\r\n\r\n          -  Corrected calcium  14 mg/dL (3.5 mmol/L).\r\n\r\n          -  AST:  2.5 times the normal upper limit.\r\n\r\n          -  ALT:  2.5 times the normal upper limit.\r\n\r\n          -  Total bilirubin:  1.5 times the normal upper limit.\r\n\r\n          -  Measured or calculated creatinine clearance of  20 mL/minute\r\n\r\n          -  Women of child bearing potential and male patients whose partner is a woman of child\r\n             bearing potential must be prepared to use two effective methods of contraception both\r\n             before and during protocol treatment, or commit to absolute and continuous\r\n             abstinence.The pregnancy test must be negative 14-28 days and 72 hours before\r\n             treatment start. Only in case of hysterectomy or presence of menopause for at least 24\r\n             consecutive months pregnancy tests as well as contraception are not necessary. Men\r\n             must not father a child for up to 6 months following cessation of treatment and must\r\n             use condoms.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any serious medical condition, laboratory abnormality, or psychiatric illness that\r\n             would prevent the subject from signing the informed consent form.\r\n\r\n          -  Pregnant or breast feeding females.\r\n\r\n          -  Any condition, including the presence of laboratory abnormalities, which places the\r\n             subject at unacceptable risk if he/she were to participate in the study or confounds\r\n             the ability to interpret data from the study.\r\n\r\n          -  Patients with contraindications for treatment with bendamustine, dexamethasone and\r\n             thalidomide.\r\n\r\n          -  Uncontrolled or severe cardiovascular disease, including myocardial infarction within\r\n             6 months before study entry, New York Heart Association Class III or IV heart failure,\r\n             uncontrolled angina or severe uncontrolled ventricular arrhythmias ( Lown 3).\r\n\r\n          -  Use of any other experimental drug or therapy within 28 days of baseline.\r\n\r\n          -  Known hypersensitivity to thalidomide or purine analogues\r\n\r\n          -  Concurrent use of other anti-cancer agents or treatments other stated in this\r\n             treatment plan.\r\n\r\n          -  Peripheral neuropathy grade 2 according to WHO\r\n\r\n          -  Known positive for HIV or infectious hepatitis, type A, B or C.\r\n\r\n          -  Major surgery less than 30 days before start of treatment\r\n      ","sponsor":"Azienda Ospedaliera di Bolzano","sponsor_type":"Other","conditions":"Multiple Myeloma","interventions":[{"intervention_type":"Drug","name":"Drug: Bendamustine","description":"Bifunctional alkylating agent consisting of a purine and amino acid antagonist (a benzimidazole ring) and an alkylating nitrogen mustard moiety."},{"intervention_type":"Drug","name":"Drug: Thalidomide","description":"Thalidomide can directly inhibit the growth and survival of myeloma cells, by oxidative damage to DNA mediated by free radicals. The drug can induce apoptosis even in drug resistant myeloma cells. Thalidomide modulates cell adhesion molecule expression, so it may interfere with the mutually stimulatory interactions between myeloma cells and the bone marrow microenvironment."},{"intervention_type":"Drug","name":"Drug: Dexamethasone","description":"It's a corticosteroid."}],"outcomes":[{"outcome_type":"primary","measure":"Response rate","time_frame":"18 months","description":"The proportion of patient with a Complete Response (CR) or Very Good Partial Response or partial response"},{"outcome_type":"primary","measure":"Incidence of haematological toxicity of BDT","time_frame":"18 months","description":"The incidence of haematological toxicities is the proportion of patients with haematological toxicity"},{"outcome_type":"secondary","measure":"Time to treatment Failure (TTF)","time_frame":"18 months","description":"To evaluate time to treatment failure"},{"outcome_type":"secondary","measure":"Survival (OS)","time_frame":"18 months","description":"To evaluate overall survival"},{"outcome_type":"secondary","measure":"Disease Free Survival (DFS)","time_frame":"18 months","description":"To evaluate disease free survival"}]}
{"nct_id":"NCT01650623","start_date":"2012-07-31","phase":"N/A","enrollment":30,"brief_title":"Gait Training With Executive Functions Tasks in Subjects With Parkinsons Disease: A Randomised Controlled Trial","official_title":"Gait Training Associated With Executive Functions Tasks in Subjects With Parkinsons Disease: A Randomised Controlled Trial","primary_completion_date":"2013-05-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2013-07-31","last_update":"2012-11-08","description":"The aim of this study is to compare two physical therapy training consisting of gait training that are distinguished by one being associated with tasks that require handling of the main executive functions, performed by individuals with Parkinson's Disease. The investigators hypothesis is that the experimental group (EG), which hold gait training with higher cognitive demands (dual-task condition), will make improvements in the parameters measured (functionality of gait and cognitive ability) to a greater extent compared to the control group (CG), which hold gait training without executive tasks (single-task condition).","other_id":"USPNEC002","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":50,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosis of Idiopathic PD performed by a neurologist specialist in movement\r\n             disorders;\r\n\r\n          -  In use of dopaminergic medication;\r\n\r\n          -  Disease severity of 1 to 3 according to Hoehn & Yahr scale;\r\n\r\n          -  Absence of other neurological disorders or co-morbidities that may affect gait;\r\n\r\n          -  Absence of dementia (score above 24 on the Mini Mental State Examination - MMSE);\r\n\r\n          -  Vision and hearing adequate or corrected to normal;\r\n\r\n          -  Ability to walk independently;\r\n\r\n          -  Absence of prolonged off state;\r\n\r\n          -  Age 50 to 85 years.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Biomechanical alterations (other pathologies) that could compromise the completion of\r\n             training;\r\n\r\n          -  Presence of depression, detected by the Geriatric Depression Scale (GDS-15);\r\n\r\n          -  Presence of any neurological, auditory or visual deficit that could compromise\r\n             distracting task performance during gait training;\r\n\r\n          -  Any changes in drug treatment for PD.\r\n      ","sponsor":"University of Sao Paulo","sponsor_type":"Other","conditions":"Parkinsons Disease","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Gait training executive functions tasks","description":"The training will consist of 10 sessions, two times per week for five weeks, and consists of 30 minutes of global exercises that involves stretching, muscle strengthen and axial mobility exercises, and another 30 minutes of gait training in a dual-task condition associated with distracting tasks that require handling of the main executive functions: volition, self-awareness, planning, response inhibition, response monitoring and attention."},{"intervention_type":"Behavioral","name":"Behavioral: Gait training alone","description":"The training will consist of 10 sessions, two times per week for five weeks, and consists of 30 minutes of global exercises that involves stretching, muscle strengthen and axial mobility exercises, and another 30 minutes of gait training alone, without other tasks."}],"outcomes":[{"outcome_type":"primary","measure":"Dynamic Gait Index","time_frame":"05/2013 (Up to ten months)","description":"The scale assesses the ability to adapt the gait during motor tasks with different demands."},{"outcome_type":"secondary","measure":"Montreal Cognitive Assessment","time_frame":"05/2013 (Up to ten months)","description":"This scale was developed in order to detect mild degrees of cognitive impairment. The instrument assesses different cognitive domains such as attention and concentration, executive functions, memory, language, visuo-constructive skills, calculations, and orientation."}]}
{"nct_id":"NCT01639547","start_date":"2012-07-31","phase":"N/A","enrollment":410,"brief_title":"Sustained Virological Response (SVR)Rate of Pegasys Plus Ribavirin in Patients With Chronic Hepatitis C","official_title":"A Randomized, Open-lable, Multicenter, Parallel Group Study to Compare SVR Rate of Pegasys Plus Ribavirin for 48 Weeks vs. 36 Weeks in Patients With Chronic Hepatitis C","primary_completion_date":"2014-07-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2014-07-31","last_update":"2015-07-29","description":"The purpose of this study is to evaluate the effect of PEGASYS (peginterferon alfa-2a 40KD) plus Robatrol (ribavirin) combination therapy given for 36 weeks versus 48 weeks on the clearance of HCV viremia 24 weeks after treatment end","other_id":"CTC-133","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  20~70 years old\r\n\r\n          -  Patients have never been treated with traditional interferon plus ribavirin or\r\n             peginterferon plus ribarivin\r\n\r\n          -  Chronic hepatitis C, genotype 1, HCV-RNA > 0.8x106 IU/ml, achieving RVR (undetectable\r\n             HCV RNA at week 4) in the SoC treatment\r\n\r\n          -  Patient must be able to comply with the assessments during the study\r\n\r\n          -  Compensated liver disease (Child-Pugh Grade A clinical classification for patients\r\n             with cirrhosis: total score  6)\r\n\r\n          -  All fertile males and females receiving ribavirin must be using two forms of effective\r\n             contraception during treatment with study drugs and 6 months post treatment completion\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History or other evidence of a medical condition associated with chronic liver disease\r\n             other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease,\r\n             alcoholic liver disease, toxin exposures)\r\n\r\n          -  History or other evidence of decompensated liver disease\r\n\r\n          -  Signs or symptoms of hepatocellular carcinoma\r\n\r\n          -  Co-infection with hepatitis A, hepatitis B or human immunodeficiency virus (HIV)\r\n\r\n          -  Not adequately controlled thyroid dysfunction, diabetes mellitus (HbA1c >8.5%) or\r\n             psychiatric disorders, especially depression. Severe psychiatric disease is defined as\r\n             treatment with an antidepressant medication or a major tranquilizer at therapeutic\r\n             doses for major depression or psychosis, respectively, for at least 3 months at any\r\n             previous time or any history of the following: a suicidal attempt, hospitalization for\r\n             psychiatric disease, or a period of disability due to a psychiatric disease\r\n\r\n          -  History of a severe seizure disorder or current anticonvulsant use\r\n\r\n          -  History of immunologically mediated disease, chronic pulmonary disease associated with\r\n             functional limitation, severe cardiac disease, major organ transplantation or other\r\n             evidence of severe illness, malignancy, or any other conditions which would make the\r\n             patient, in the opinion of the investigator, unsuitable for the study\r\n\r\n          -  Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration) or clinically\r\n             relevant ophthalmological disorder (e.g. due to diabetes mellitus or hypertension)\r\n\r\n          -  Women with on-going pregnancy or breast feeding\r\n\r\n          -  Male partners of women who are pregnant\r\n\r\n          -  Subjects with any of the following laboratory abnormalities\r\n\r\n               -  Platelet count < 90,000/mm3\r\n\r\n               -  Absolute neutrophil count < 1,500 /mm3\r\n\r\n               -  Hemoglobin < 12 g/dL (F), 13 g/dL (M)\r\n\r\n               -  Creatinine > ULN\r\n\r\n               -  ALT and/or AST > 10X ULN\r\n\r\n               -  Total serum bilirubin > 1.5 x ULN\r\n\r\n          -  Inability or unwillingness to provide written informed consent or abide by the\r\n             requirements of the study\r\n      ","sponsor":"Chang Gung Memorial Hospital","sponsor_type":"Other","conditions":"Chronic Hepatitis C","interventions":[{"intervention_type":"Drug","name":"Drug: Peginterferon alfa-2a plus Ribavirin","description":"Peginterferon alfa-2a(pre-filled syringes 180 mcg/0.5 ml once a week) plus ribavirin(200 mg/Capsules, 1000~1200 mg daily in split doses (morning/evening)) for 36 or 48 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Sustained virological response","time_frame":"At 24 weeks after end of treatment","description":"Sustained virological response (SVR) defined as percentage of patients with HCV RNA < 15 IU/ML as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test at 24 weeks post completion of the 36 or 48 week treatment periods."},{"outcome_type":"secondary","measure":"Virological Response Rate at week 2","time_frame":"At treatment week 2","description":"Virological Response Rate at week 2 defined as the percentage of patients with HCV RNA < 15 IU/ML as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV at 2 weeks post treatment."},{"outcome_type":"secondary","measure":"Virological response at end of treatment","time_frame":"At end of treatment","description":"Virological response at end of treatment defined as the percentage of patients with HCV RNA < 15 IU/ML as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test after the last dose of study medication(± 28 days)."},{"outcome_type":"secondary","measure":"Correlation of virological response and SVR rate","time_frame":"At 24 weeks after end of treatment","description":"Correlation of virological response (HCV RNA < 15 IU/ML) at week 2 and SVR rate in each group."}]}
{"nct_id":"NCT01641055","start_date":"2012-07-31","phase":"N/A","enrollment":93,"brief_title":"A Study of the Effects of Fish Protein Intake on Glucose Regulation in Overweight and Obese Adults.","official_title":"A 8 wk Study to Compare the Effects of Proteins Various Fish Species (Salmon, Herring, Cod) and Milk on Glucose Regulation in Overweight and Obese Adults.","primary_completion_date":"2012-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-11-30","last_update":"2021-02-23","description":"The purpose of this study is to compare the possible health benefits of intake of proteins from salmon, herring, cod and milk on glucose tolerance in overweight and obese adults. Overweight and obese subjects often have reduced glucose tolerance, and previous findings from a study on cod proteins suggested that glucose tolerance was improved.","other_id":"2011/572","allocation":"Randomized","intervention_model":"Factorial Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":69,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  BMI above 27 kg/m2\r\n\r\n          -  healthy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  fasting blood glucose above 7 mM\r\n\r\n          -  medication that affects blood glucose, lipids and inflammatory status\r\n\r\n          -  pregnancy or breastfeeding\r\n\r\n          -  allergies to fish or milk\r\n\r\n          -  intentional weight loss and large fluctuation in body weight\r\n\r\n          -  a high consumption of fish\r\n\r\n          -  an extreme diet\r\n\r\n          -  use of fish oil, n-3 or multivitamin supplements\r\n      ","sponsor":"University of Bergen","sponsor_type":"Other","conditions":"Obesity|Overweight","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Salmon protein hydrolysate","description":"2.5g salmon protein hydrolysate per day for 8wk."},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Herring protein hydrolysate","description":"2.5g herring protein hydrolysate per day for 8wk."},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Cod protein","description":"2.5g cod protein per day for 8wk."},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Milk protein","description":"2.5g milk protein per day for 8wk."}],"outcomes":[{"outcome_type":"primary","measure":"Glucose regulation","time_frame":"8 weeks","description":"Glucose will be measured in fasting and postprandial samples"},{"outcome_type":"secondary","measure":"Changes in serum insulin, insulin C-peptide, non-esterified fatty acids, lipids, adiponectin, leptin and fatty acid composition","time_frame":"8 weeks"},{"outcome_type":"secondary","measure":"Changes in serum and urine concentrations of amino acids and their metabolites","time_frame":"8 weeks"},{"outcome_type":"secondary","measure":"Changes in serum concentrations of vitamins","time_frame":"8 weeks"}]}
{"nct_id":"NCT01681979","start_date":"2012-07-31","enrollment":1,"brief_title":"WEUSRTP4850: Phase II: ICS/LABA Use in Pregnancy and Outcomes","official_title":"WEUSRTP4850: Phase II: Asthma Treatment in Pregnancy and the Frequency of Adverse Pregnancy Outcomes","primary_completion_date":"2013-08-31","study_type":"Observational","rec_status":"Completed","completion_date":"2013-08-31","last_update":"2014-10-01","description":"Asthma is reported to affect between 3-14% of pregnancies making asthma medicines one of the most commonly used classes of medicines during pregnancy. Maternal asthma and in particular poorly controlled asthma has been found to be associated with a number of adverse perinatal outcomes including preterm delivery, low birth weight and pre-eclampsia. At present little is known about the safety in humans of many anti-asthma medicines when used during pregnancy. As a result all inhaled corticosteroids, with the exception of budesonide which is category B, have an FDA pregnancy category C, indicative of the fact there are no adequate and well controlled studies in humans. Fluticasone propionate is an inhaled corticosteroid used for the treatment of asthma, often in combination with the long-acting -agonist salmeterol. Owing to small numbers of pregnancy exposures in the past, little is known about the safety of fluticasone propionate when used during pregnancy. A recent feasibility study, however, has shown that there are sufficient numbers of first trimester exposed pregnancies on the General Practice Research Database (GPRD) to allow the overall risk of major congenital malformations (MCMs) to be evaluated. This study also demonstrated that using data from the GPRD it is possible to determine an individual's exposure to anti-asthma medicines during pregnancy and to classify her treatment in terms of the British Thoracic Society treatment steps based on linked prescription and primary care data. The aims of this study are to 1) evaluate the safety profile of fluticasone propionate (FP) compared with exposure to all other inhaled corticosteroids with all major congenital malformations combined as the primary endpoint, whilst taking into account potential confounders and exposure to other anti-asthma medicine; and 2) test the null hypothesis that exposure to fluticasone propionate during the first trimester of pregnancy is not associated with increased overall risk of all major congenital malformations when compared to the risk in those exposed to other inhaled corticosteroids during the first trimester of pregnancy. The study will be a retrospective cohort study and will use data from the United Kingdom's General Practice Research Database (GPRD). The GPRD contains longitudinal medical records collected within UK primary care. All medical symptoms and diagnoses are recorded in the database, including those relating to pregnancy, in the form of Read Codes. In addition to coded data GPs have the option of recording un-coded comments ('free text'), such as more detailed descriptions of diagnoses or treatments along with information provided to them via hospital letters, referrals and discharge summaries. As the recording of stillbirths, neonatal deaths and pre-term births on the GPRD has not been verified, a verification exercise will be carried out. This will involve requesting and reviewing free text comments for 100 stillbirths, 100 neonatal deaths and 100 pre-term births. Free text comments will be requested if they are associated with a medical code related to pregnancy, delivery, post natal visits, death, post mortem, hospital letters and other forms of communication. If the free text is not found to be informative we will send questionnaires to the woman's GP. All outcomes will be identified and verified blinded to asthma treatment and severity levels.","other_id":"114593","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"Female","minimum_age":11,"maximum_age":50,"population":"The study population will consist of all eligible pregnancies identified from the source\r\n        population where the female is considered to have asthma. The source population will be all\r\n        pregnancies identified on the GPRD that started and ended between 1 January 2000 and 31\r\n        December 2010.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  female patients whose pregnancy was registered on the GPRD and started and ended\r\n             between 1 January 2000 and 31 December 2010\r\n\r\n          -  Patients are considered to have asthma based on diagnosis and prescription codes\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  patients not registered with a practice contributing up-to-standard data to the GPRD\r\n             for the 6 months before the start of pregnancy, throughout pregnancy and for the 3\r\n             months following the pregnancy end date.\r\n\r\n          -  patients not 11-50 years of age on the pregnancy start date\r\n\r\n          -  patients who experienced multiple birth (twins, triplets)\r\n\r\n          -  patients with a medical code for a diagnosis of chronic obstructive pulmonary disease\r\n             (COPD) or any other chronic respiratory condition (e.g. cystic fibrosis) recorded at\r\n             anytime before the pregnancy end date\r\n      ","sponsor":"GlaxoSmithKline","sponsor_type":"Industry","conditions":"Asthma","interventions":[{"intervention_type":"Drug","name":"Drug: Fluticasone propionate (with and without concurrent salmeterol)","description":"Fluticasone propionate is an inhaled corticosteroid used for the treatment of asthma, often in combination with the long-acting -agonist salmeterol. For the primary endpoint, exposure status will be determined based on the individual receiving a prescription for the drug of interest (fluticasone propionate or another inhaled corticosteroid) in the 2 weeks immediately before the LMP date or during the first trimester of pregnancy.\r\nSensitivity analysis will be carried out categorising exposure based on mapping the duration of prescriptions based on the number of inhalers, number of puffs within an inhaler and the prescribed daily dose."}],"outcomes":[{"outcome_type":"primary","measure":"All major congenital malformations (MCMs) combined","time_frame":"11 years (January 1, 2000 to December 31, 2010)"},{"outcome_type":"secondary","measure":"Secondary outcomes associated with measures of asthma control, not drug exposures of interest including Spontaneous pregnancy losses, pre-term births, and Stillbirths and neonatal deaths.","time_frame":"11 years (January 1, 2000 to December 31, 2010)","description":"Spontaneous pregnancy losses will be defined as losses that occurred > 24 wks gestation from the date of the first day of the last menstrual period (LMP) (identified based on the pregnancy algorithm). For pregnancy losses where the type of loss is unknown any free text comments associated with the code will be requested & reviewed. Pre-term births will be defined as a live birth delivered at <37 complete wks gestation from the date of the first day of the LMP (identified based on medical codes for a pre-term delivery in addition to gestational age & first day of LMP). Stillbirths =>24 wks."}]}
{"nct_id":"NCT01659762","start_date":"2012-07-31","phase":"Phase 1","enrollment":16,"brief_title":"A Phase I Study Evaluating Autologous Bone Marrow Derived Mesenchymal Stromal for Crohn's Disease.","official_title":"A Phase I Study Evaluating Safety and Tolerability of Autologous Bone Marrow Derived Mesenchymal Stromal (MSC) Cells in Adults With Moderate to Severe Crohn's Disease.","primary_completion_date":"2015-07-31","study_type":"Interventional","rec_status":"Completed","last_update":"2016-10-17","description":"In this Phase I trial the investigators intend to show safety and tolerability of autologous MSC, expanded using a non-xenogeneic, human component platelet lysate expansion media. Fresh, non cryopreserved, autologous MSCs will delivered intravenously as a single bolus dose in a dose escalation phase I study. The investigators intend to test whether the product is clinically safe in adults (18-65 years old) with CD and to determine maximal deliverable dose. Secondary endpoint will monitor effectiveness using CDAI as an endpoint.","other_id":"IRB00051454","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria\r\n\r\n          -  Men and women 18-65 years of age.\r\n\r\n          -  Patient must have had CD for at least 3 months from the time of initial diagnosis. The\r\n             diagnosis of CD must have been confirmed by endoscopic and histological evidence.\r\n\r\n          -  Patients must have active Crohn's disease as defined by a Crohns Disease Activity\r\n             Index (CDAI) score between >220 at screening and baseline.\r\n\r\n          -  Patients should have no need for immediate surgery (i.e. due to obstruction,\r\n             strictures, active abscess or perforations ).\r\n\r\n          -  Subjects must be refractory (defined as lack of response for at least 3 months) to\r\n             immunomodulators (including 6-mercaptopurine and azathioprine and methotrexate) or\r\n             anti-TNF therapy at present or some point in the course of their disease. Lack of\r\n             response is defined by failure to reduce the CDAI score by at least 70 points.\r\n\r\n          -  The following medications will be allowed: mesalamine and prednisone (stable dose for\r\n             at least 2 weeks prior to enrollment).\r\n\r\n          -  Subjects on anti TNF therapy will require a minimum of 4 weeks washout period prior to\r\n             screening.\r\n\r\n          -  Subjects on non-steroidal analgesics require a minimum of 2 weeks washout period prior\r\n             to screening\r\n\r\n          -  If female and of child-bearing age, patient must be non-pregnant, non-breastfeeding,\r\n             and use adequate contraception;\r\n\r\n          -  Patient is willing to participate in the study and has signed the informed consent.\r\n      ","sponsor":"Emory University","sponsor_type":"Other","conditions":"Crohn's Disease","interventions":[{"intervention_type":"Biological","name":"Biological: autologous mesenchymal stromal cell"}],"outcomes":[{"outcome_type":"primary","measure":"Number of adverse events","time_frame":"12 months","description":"Monitoring for adverse events at time of MSC infusion and in 12 months following"},{"outcome_type":"secondary","measure":"Crohn's disease activity Index (CDAI)","time_frame":"12 months","description":"CDAI score before and after intervention will be monitored over 12 months"}]}
{"nct_id":"NCT01752257","start_date":"2012-07-31","phase":"Phase 1","enrollment":15,"brief_title":"EF5 in Melanoma Patients","official_title":"Pilot Study to Characterize the HRHV Axis in the Microenvironment of Melanoma in Patients Undergoing Isolated Limb Infusion or Hypothermic Isolated Limb Perfusion With Melphalan","primary_completion_date":"2014-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-08-31","last_update":"2015-03-09","description":"The purpose of this pilot study is to determine the prevalence of markers of chronic and cycling hypoxia and reactive species stress (oxidative and nitrosative) in the melanoma tumor microenvironment. The study is based around four cornerstone features of the pathologic microenvironment - Hypoxia, Reactive Species (reactive oxygen and nitrogen species), HIF-1 and VEGF, which the investigators term the HRHV axis. Patients with in-transit melanoma (AJCC Stage IIIB or IIIC) (1) will be administered the hypoxia marker drug, EF5, 24 hr prior to isolated limb infusion (ILI) or hyperthermic isolated limb perfusion (HILP). Tumor biopsies will be performed just prior to ILI or HILP, at the 30 minute time point during ILI (or 60 minute time point during HILP), AND 24 hours after ILI or HILP. Tissues obtained will be snap frozen and subsequently analyzed for EF5 binding. Immunohistochemical analysis of a cohort of immunohistochemical and urine markers that depict the HRHV axis will also be examined. The association of the markers with the presence of hypoxia, as determined by EF5 positivity, will be determined. Data from this pilot study will be used to establish the prevalence of markers of the HRHV axis in melanoma. This information will be crucial for future human trials in which the HRHV axis is therapeutically targeted.","other_id":"Pro00033938","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        3.1. Inclusion criteria\r\n\r\n          -  Histologically confirmed AJCC Stage IIIB/IIIC/IV extremity melanoma who are undergoing\r\n             ILI or HILP and have tumor available for biopsy (NOTE: patients with only 1 in-transit\r\n             lesion are NOT eligible)\r\n\r\n          -  Age 18\r\n\r\n          -  KPS status  70\r\n\r\n          -  Bilirubin  1.5x normal\r\n\r\n          -  Creatinine  1.8 ( -EF5 is primarily excreted via the kidney)\r\n\r\n          -  WBC > 3000/mm3 and platelets > 100,000/mm3\r\n\r\n        3.2. Exclusion criteria\r\n\r\n          -  Pregnancy or breast feeding. A negative serum pregnancy test is required of any women\r\n             childbearing potential prior to enrollment. Pregnant women are excluded from this\r\n             study because EF5 is an agent with potential for teratogenic or abortifacient effects.\r\n             Because there is an unknown but potential risk for adverse events in nursing infants\r\n             secondary to treatment of the mother with EF5, breastfeeding should be discontinued if\r\n             the mother is given EF5.\r\n\r\n          -  Allergy to IV contrast dye\r\n\r\n          -  History of grade III or IV peripheral neuropathy as defined by the NCI CTC (other\r\n             2-nitroimidazole compounds are neurotoxic)\r\n\r\n          -  Previous history of any malignancy treated with radiotherapy and/or chemohormonal\r\n             therapy\r\n      ","sponsor":"Douglas Tyler","sponsor_type":"Other","conditions":"Melanoma","interventions":[{"intervention_type":"Drug","name":"Drug: EF5 Hypoxia","description":"EF5 is a dye used to measure hypoxia"}],"outcomes":[{"outcome_type":"primary","measure":"Spatial comparison between marker proteins and hypoxia.","time_frame":"2 years","description":"We will describe the distribution of the markers at each of the three time points with boxplots and means (with 80% confidence intervals). The variance of each marker will be partitioned into three parts: variance due to the time (i.e., treatment) effect, variance among patients, and error variance. This calculation can easily be done by fitting a general linear model in which marker is regressed on an n-1 degree of freedom patient effect (where n is the number of patients) and a 2 degree of freedom time effect. The error variance with 2*(n-1) degrees of freedom is of course equal to the variance of the interaction of patient with time. Obviously, we would hope to find that the variance for the time effect is larger than either of the other two variances."}]}
{"nct_id":"NCT01607268","start_date":"2012-07-31","enrollment":6,"brief_title":"Magnetic Resonance Spectroscopy in Autonomic Failure","official_title":"Proton Magnetic Resonance Spectroscopy in Primary Autonomic Failure","primary_completion_date":"2017-01-31","study_type":"Observational","rec_status":"Terminated","completion_date":"2017-01-31","last_update":"2017-01-18","description":"This research study will be conducted in patients with primary autonomic failure, a disabling condition that is associated with low blood pressure upon standing. These patients are also not able to control for changes in their blood pressure due to a loss of cardiovascular reflexes that are mediated within the brain. The purpose of this study is to determine whether magnetic resonance spectroscopy (MRS), a non-invasive imaging technique, can measure levels of chemicals (neurotransmitters) in the dorsal medulla, a brain area important for control of cardiovascular function, in autonomic failure patients. Importantly, this study will determine whether there are differences in brain chemicals between patients with peripheral versus central origins of their autonomic failure. The hypothesis is that the neurotransmitter profile in the medulla will be intact in patients with peripheral autonomic failure compared to those with central impairment. Overall, this study will provide insight into understanding the mechanisms involved in autonomic failure and will determine whether a single session of MRS imaging can improve the ability to make an accurate diagnosis in these patients. This would lessen the need for more extensive and invasive clinical testing.","other_id":"120574","observational_model":"Case-Control","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":80,"population":"Primary autonomic failure patients will be recruited from patients already in the hospital\r\n        participating in the approved protocol \"The Evaluation and Treatment of Autonomic Failure.\"\r\n        Prospective participants come from several sources including clinic patients, former\r\n        patients, referrals from other physicians, and subjects that read about the Autonomic\r\n        Dysfunction Center on the Vanderbilt website.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with primary autonomic failure who are already participating in the approved\r\n             Vanderbilt study \"Evaluation and Treatment of Autonomic Failure\"\r\n\r\n          -  Males and females of all races between 18 and 80 years of age\r\n\r\n          -  Able and willing to provide informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnant women\r\n\r\n          -  Patients with diagnosed Parkinson's Disease or secondary forms of autonomic failure\r\n\r\n          -  Patients with severe claustrophobia\r\n\r\n          -  Patients taking medications known to affect brain neurotransmitter levels [e.g.,\r\n             anti-depressants, barbiturates, benzodiazepines, gabapentin, namenda, sinemet]\r\n\r\n          -  Patients with implanted medical devices [e.g., pacemakers, metal clips, cochlear\r\n             implants, orthopedic hardware], lead-based tattoos or pieces of metal close to or in\r\n             an important organ\r\n\r\n          -  High-risk patients [e.g., heart failure, symptomatic coronary artery disease, liver\r\n             impairment, history of stroke or myocardial infarction]\r\n\r\n          -  Inability to give or withdraw informed consent\r\n\r\n          -  Other factors which in the investigator's opinion would prevent the subject from\r\n             completing the protocol including significant abnormalities in clinical, mental, or\r\n             laboratory testing\r\n      ","sponsor":"Vanderbilt University","sponsor_type":"Other","conditions":"Pure Autonomic Failure|Multiple System Atrophy","interventions":[{"intervention_type":"Procedure","name":"Procedure: Magnetic Resonance Spectroscopy Imaging","description":"Proton magnetic resonance spectroscopy [1H-MRS] is an emerging imaging tool that allows for non-invasive assessment of brain neurochemistry in human subjects. This technique allows for in vivo quantification of the concentration of neurotransmitters and metabolites in discrete brain regions through detection of hydrogen nuclei in these molecules. Autonomic failure patients will undergo a single imaging session lasting 30 to 90 minutes (0.5-1.5 hours) in the Vanderbilt Human Imaging Institute."}],"outcomes":[{"outcome_type":"primary","measure":"N-Acetylaspartate Levels","time_frame":"0.5-1.5 hours","description":"Differences in levels of N-acetylaspartate in the dorsal medulla of pure autonomic failure versus multiple system atrophy patients using single session imaging."},{"outcome_type":"secondary","measure":"Myoinositol Levels","time_frame":"0.5-1.5 hours","description":"Differences in levels of myoinositol in the dorsal medulla pure autonomic failure versus multiple system atrophy patients."},{"outcome_type":"secondary","measure":"GABA Levels","time_frame":"0.5-1.5 hours","description":"Differences in levels of the neurotransmitter GABA in the dorsal medulla of pure autonomic failure versus multiple system atrophy patients."},{"outcome_type":"secondary","measure":"Creatinine Levels","time_frame":"0.5-1.5 Hours","description":"Differences in levels of creatinine-containing compounds in the dorsal medulla of pure autonomic failure versus multiple system atrophy patients."},{"outcome_type":"secondary","measure":"Choline Levels","time_frame":"0.5-1.5 Hours","description":"Differences in levels of choline-containing compounds in the dorsal medulla of pure autonomic failure versus multiple system atrophy patients."},{"outcome_type":"secondary","measure":"Glutamate Levels","time_frame":"0.5-1.5 Hours","description":"Differences in levels of glutamate in the dorsal medulla of pure autonomic failure versus multiple system atrophy patients."}]}
{"nct_id":"NCT01912430","start_date":"2012-07-31","phase":"N/A","enrollment":17559,"brief_title":"Retrospective Data Analysis of VitalCare Targeted Population Management on Scott and White Chronically Ill Beneficiaries","official_title":"Retrospective Data Analysis of the Impact of Vital Care Targeted Population Management Upon a Matched Cohort of Scott and White Health Plan Beneficiaries","primary_completion_date":"2012-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-12-31","last_update":"2013-08-01","description":"New payment methods such as Accountable Care Organization (ACO's) and medical homes facilitate are new models for providers to deliver cost effective, quality patient outcomes. Integrated Care Coaching (ICC) is a healthcare delivery model combining telephonic interventions with an intelligent information technology platform that offered validated protocols and patient outcomes tracking. Health Integrated, Inc. has developed a validated program of Integrated Care Coaching (ICC), which was branded as \"VitalCare\", and implemented with over 7,000 members of the Scott and White Health Plan in Texas, would reduce healthcare costs/achieve a return on investment (ROI), improve clinical outcomes, and be satisfying for participants.","other_id":"120246","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18 years or older\r\n\r\n          -  Having one or more of 21 chronic conditions, including those with depression and\r\n             multiple chronic comorbidities.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Presence of Major Cancer, HIV, or ESRD in either the baseline or measurement periods\r\n\r\n          -  Claims in excess of $100,000 in either baseline or intervention period.\r\n\r\n          -  Claims for long term care or hospice in either baseline or intervention period.\r\n      ","sponsor":"Scott & White Health Plan","sponsor_type":"Industry","conditions":"Chronic Illness","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: ICC (Integrated Care Coaching) Intervention Group"}],"outcomes":[{"outcome_type":"primary","measure":"Return of Investment and Cost of Medical Care","time_frame":"6 to 12 months","description":"Primary outcomes were ROI and cost of medical care (including inpatient, outpatient, emergency room, office and other (ie, physical therapy). ICC participants and control group members had a minimum of 6 months to a maximum of 12 months measurement period."},{"outcome_type":"secondary","measure":"Level of Depressive Symptoms per Interactive Patient Health Questionnaire (PHQ-9) scores","time_frame":"6 to 12 months","description":"Secondary outcome was level of depressive symptoms per Interactive Patient Health Questionnaire (PHQ-9) scores. ICC participants and control group members had a minimum of 6 months to a maximum of 12 months measurement period."},{"outcome_type":"other","measure":"Patient Satisfaction","time_frame":"6 to 12 months"}]}
{"nct_id":"NCT01648517","start_date":"2012-07-27","phase":"Phase 2","enrollment":60,"brief_title":"Genotype-Driven Treatment of Advanced Non-small Cell Lung Cancer Based on mRNA Expression of ERCC1 & RRM1 as First-line Chemotherapy","primary_completion_date":"2015-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-06-30","last_update":"2017-11-28","description":"This is a prospective phase II trial, in patients with unresectable or metastatic NSCLC using chemotherapy regimens which will be defined according to the mRNA expression of ERCC1 and RRM1 of the tumor cells.","other_id":"4-2008-0132","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Histologically confirmed unresectable advanced or metastatic non-small cell lung\r\n             cancer (NSCLC) (stage IIIB or IV)\r\n\r\n          2. Chemotherapy nave patient (Previous adjuvant or neoadjuvant chemotherapy allowed if\r\n             the last dose was administered equal to or greater than 6 months ago.)\r\n\r\n          3. Age > 18\r\n\r\n          4. Performance status 0 to 2 by Eastern Cooperative Oncology Group (ECOG) criteria\r\n\r\n          5. At least one measurable lesion by Response Evaluation Criteria In Solid Tumors\r\n             (RECIST)\r\n\r\n          6. Adequate organ functions (assessed within 14 days of starting treatment) 1) Bone\r\n             marrow: Absolute neutrophil count  1,500/mm, Platelet count  100,000/mm,\r\n             Hemoglobin  9.0 mg/dL 2) Liver: Total bilirubin  1.5 x ULN; aspartic transaminase\r\n             (AST) and alanine transaminase (ALT), alkaline phosphatase(ALP)  2.5 x ULN 3) Kidney:\r\n             Serum creatinine  1.5 x ULN\r\n\r\n          7. Signed informed consent document\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Clinically significant serious illness or medical condition (infection)\r\n\r\n          2. Prior systemic chemotherapy or immunotherapy for advanced NSCLC.\r\n\r\n          3. Presence of uncontrolled brain or leptomeningeal metastases\r\n\r\n          4. Prior radiotherapy within 3 weeks of starting treatment\r\n\r\n          5. Peripheral neuropathy equal to or greater than grade 2 by Common Terminology Criteria\r\n             for Adverse Events (CTCAE) v4.0\r\n\r\n          6. Pregnant or lactating\r\n\r\n          7. Absolute contraindication of corticosteroid use\r\n\r\n          8. Patients with a history of severe hypersensitivity reaction to docetaxel, carboplatin,\r\n             vinorelbine or gemcitabine\r\n      ","sponsor":"Yonsei University","sponsor_type":"Other","conditions":"Non-small Cell Lung Carcinoma","interventions":[{"intervention_type":"Drug","name":"Drug: chemotherapy","description":"A1: docetaxel 60mg/m2 on Day 1 vinorelbine 20mg/m2 on Day 1 and Day 8 (DV) A2: gemcitabine 1000mg/m2 on Day 1 vinorelbine 25mg/m2 on Day 1 and Day 8 (GV) A3: docetaxel 75mg/m2 on Day 1 carboplatin AUC5 on Day 1 (DC) A4: gemcitabine 1000mg/m2 on Day 1 and 8 carboplatin AUC5 on Day 1 (GC)"},{"intervention_type":"Drug","name":"Drug: chemotherapy","description":"Drug: Docetaxel 75mg/m2 IV on Day 1 Drug: Carboplatin AUC5 IV on Day 1"}],"outcomes":[{"outcome_type":"primary","measure":"overall Response Rate","time_frame":"From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months","description":"ORR was assessed by tumor response evaluation according to RECIST 1.1 at every 8 weeks. Tumor assessments will continue about every 8 weeks until disease progression or initiation of subsequent anticancer treatment.\r\n(If PR or CR was first documented, confirmation assessment was done between 4 weeks and 8 weeks)"},{"outcome_type":"secondary","measure":"Progression free survival","time_frame":"up to 4 years"},{"outcome_type":"secondary","measure":"overall survival","time_frame":"up to 4 years"},{"outcome_type":"secondary","measure":"duration of response","time_frame":"up to 4 years"},{"outcome_type":"secondary","measure":"disease control rate","time_frame":"up to 4 years"}]}
{"nct_id":"NCT01087281","start_date":"2012-07-23","enrollment":132,"brief_title":"Top-Down Attentional Control of Visual-Processing","official_title":"Top-Down Attentional Control of Visual-Processing","study_type":"Observational","rec_status":"Recruiting","last_update":"2021-08-10","description":"Background: - Previous studies have shown that people with certain types of brain damage may have particular problems paying attention and processing things that they see. Researchers are interested in comparing how people with brain damage and without brain damage process visual images. Objectives: - To better understand the areas of the brain involved in paying attention to things that are seen. Eligibility: - Individuals at least 18 years of age who either have had damage to one or both sides of specific parts of the brain (e.g., stroke, injury, certain neurosurgery procedures) or are healthy volunteers. Design: - The study involves 4 to 10 visits to the NIH Clinical Center over 1 to 2 years. Each visit will last approximately 2 hours. - Participants will be screened with a medical history and physical examination, and may have the cognitive testing described below during the same visit. - On the first visit and for at least one visit thereafter, participants will have cognitive testing to evaluate thinking and memory. These tests will be either written tests or computer-based tests. - Some participants will qualify for functional magnetic resonance imaging (fMRI) as part of the study. This part will involve a decision-making task that will be performed on a computer during the fMRI scan. Additional scans may be required as directed by the study doctors. - Some randomly selected participants will be asked to have magnetoencephalography (MEG), a procedure to record very small magnetic field changes produced by brain activity. - During the behavioral training, or fMRI or MEG scanning, participants may be monitored with equipment to track eye movements.","other_id":"100047","observational_model":"Case-Control","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Healthy volunteers 18 years of age or older who are neurologically normal and in good\r\n        general health. Patients 18 years of age or older with unilateral or bilateral focal\r\n        lesions of prefrontal, parietal, occipital or temporal cortex, or amygdala.","criteria":"\n        -  INCLUSION CRITERIA:\r\n\r\n        All Subjects\r\n\r\n          1. All subjects will be 18 years of age or older and have at least a high school\r\n             education.\r\n\r\n          2. Capacity to provide their own informed consent, understand and cooperate with study\r\n             procedures.\r\n\r\n        Patients:\r\n\r\n          1. Unilateral or bilateral focal lesions of prefrontal, parietal, occipital or temporal\r\n             cortex, or amygdala.\r\n\r\n          2. At least three months post-stroke, lobectomy and or neurosurgical resection.\r\n\r\n        Healthy volunteers:\r\n\r\n        1. Neurologically normal and in good general health.\r\n\r\n        EXCLUSION CRITERIA\r\n\r\n        Patients:\r\n\r\n          1. Any neurological or psychiatric disorder not related to the focal lesion (e.g.,\r\n             epilepsy, schizophrenia, etc.). Epilepsy patients who have undergone surgery and as a\r\n             result are seizure free may be recruited.\r\n\r\n          2. Previous head injury.\r\n\r\n          3. Present or past (within past 6 months) drug or alcohol abuse or addiction as\r\n             determined by a qualified study neurologist/psychiatrist.\r\n\r\n          4. Radiation treatment to the brain during a three-month period prior to the experiment.\r\n\r\n          5. NIMH staff and their immediate family are excluded from participation.\r\n\r\n        Healthy Volunteers:\r\n\r\n          1. Any neurological or psychiatric disorder (e.g., epilepsy, schizophrenia, etc.)\r\n\r\n          2. Previous head injury.\r\n\r\n          3. Present or past (within past 6 months) drug or alcohol abuse or addiction based on\r\n             DSM-5 criteria as determined during History and Physical exam.\r\n\r\n          4. NIMH staff and their immediate family are excluded from participation.\r\n\r\n        ADDITIONAL EXCLUSION CRITERIA FOR MRI SCAN:\r\n\r\n        Patients and Healthy volunteers:\r\n\r\n          1. Women who are pregnant and women of child-bearing potential who refuse to undergo a\r\n             urine pregnancy test will be excluded from fMRI experiments but included in cognitive\r\n             experiments.\r\n\r\n          2. Subjects who have contraindications to MRI scanning will be excluded from FMRI\r\n             experiments but included in cognitive experiments. These contraindications include:\r\n\r\n               1. central nervous system aneurysm clips;\r\n\r\n               2. implanted neural stimulator;\r\n\r\n               3. implanted cardiac pacemaker or defibrillator;\r\n\r\n               4. cochlear implant;\r\n\r\n               5. ocular foreign body (e.g., metal shavings);\r\n\r\n               6. insulin pump;\r\n\r\n               7. metal shrapnel or bullet;\r\n\r\n               8. any implanted device that is incompatible with MRI.\r\n\r\n          3. Conditions that preclude scanning, e.g., morbid obesity, claustrophobia.\r\n\r\n        ADDITIONAL EXCLUSION CRITERIA FOR TASKS INVOLVING COLOR DISCRIMINATION:\r\n\r\n        Patients and Healthy volunteers:\r\n\r\n        Subjects who are determined during screening or history and physical exam to be color-blind\r\n        will be excluded from participating in certain tasks that involve color discrimination.\r\n      ","sponsor":"National Institute of Mental Health (NIMH)","sponsor_type":"NIH","conditions":"Focal Brain Lesion|Focal Lesions|fMRI","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"MRI signal across the whole brain during the MRI scans","time_frame":"Ongoing","description":"The MRI signal varies with cortical area and with the stimuli and tasks performed by the subjects."},{"outcome_type":"secondary","measure":"To determine the differential top-down contributions of prefrontal and parietal regions in processes selective and sustain attention, filtering of distracter information, orienting of attention, and attention engagement and disengagement."}]}
{"nct_id":"NCT01672775","start_date":"2012-07-18","phase":"Phase 1","enrollment":34,"brief_title":"A Study to Assess the Safety, Pharmacokinetics and Effectiveness of AGS-16C3F Monotherapy in Subjects With Renal Cell Carcinoma (RCC) of Clear Cell or Papillary Histology","official_title":"A Phase 1, Open Label, Multi-center Study to Assess the Safety, Pharmacokinetics and Effectiveness of AGS-16C3F Monotherapy in Subjects With Renal Cell Carcinoma (RCC) of Clear Cell or Papillary Histology","primary_completion_date":"2017-02-21","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-02-21","last_update":"2020-12-19","description":"The purpose of this study is to evaluate the safety and pharmacokinetics and assess the immunogenicity and effectiveness of AGS-16C3F in subjects with renal cell cancer (RCC).","other_id":"AGS-16C3F-12-2","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Dose determination cohorts: Histologically confirmed diagnosis of metastatic RCC of\r\n             either clear cell or non-clear histology.\r\n\r\n               -  Tumors with clear cell histology: subject must have progressed after at least one\r\n                  anti-vascular endothelial growth factor receptor (anti-VEGFR) therapy\r\n\r\n               -  Tumors with non-clear cell histology must be ectonucleotide\r\n                  pyrophosphatase/phosphodiesterase family member 3 (ENPP3) positive at\r\n                  pre-screening. This sub-group does not have any prior therapy requirement.\r\n\r\n          -  Dose expansion cohorts: Histologically confirmed diagnosis of metastatic RCC of either\r\n             clear cell or papillary histology\r\n\r\n               -  Tumors with clear cell histology: subject must have progressed after at least one\r\n                  anti-VEGFR therapy\r\n\r\n               -  Tumors with papillary histology: includes unclassified histology with papillary\r\n                  features and must be ENPP3 positive at pre-screening. This sub-group does not\r\n                  have any prior therapy requirement.\r\n\r\n          -  Measurable disease according to Response Criteria for Solid Tumors (RECIST Version\r\n             1.1)\r\n\r\n          -  Eastern Cooperative Group (ECOG) performance status of 0-1\r\n\r\n          -  Hematologic function, as follows:\r\n\r\n               -  Absolute neutrophil count (ANC)  1.5 x 109/L\r\n\r\n               -  Platelet count  100 x 109/L\r\n\r\n               -  Hemoglobin  9 g/dL (transfusions are allowed)\r\n\r\n          -  Renal function, as follows:\r\n\r\n               -  creatinine  1.5 x upper limit of normal (ULN), or calculated glomerular\r\n                  filtration rate (GFR) > 50 mL/min if creatinine > 1.5x ULN\r\n\r\n          -  Hepatic function, as follows:\r\n\r\n               -  Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT)  2.5 x ULN\r\n                  or  5x ULN if known liver metastases\r\n\r\n               -  Total bilirubin 1.5 x ULN\r\n\r\n          -  International normalized ratio (INR) < 1.3 (or  3.0 if on therapeutic\r\n             anticoagulation)\r\n\r\n          -  Women and men of childbearing potential must be advised and agree to practice\r\n             effective methods of contraception during the course of the study and for 4 weeks\r\n             after the last AGS-16C3F infusion administration\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Current uncontrolled central nervous system (CNS) metastasis or malignant brain tumors\r\n\r\n          -  Use of any investigational drug (including marketed drugs not approved for this\r\n             indication) within 4 weeks prior to screening. No time limit applies to the use of\r\n             marketed drugs approved for this indication provided that the subject has progressed\r\n             on the treatment and all toxicities attributable to the drug have resolved or returned\r\n             to baseline\r\n\r\n          -  Known sensitivity to any of the ingredients of the investigational product AGS-16C3F\r\n\r\n          -  History of thromboembolic events and bleeding disorders 3 months (e.g., (deep vein\r\n             thrombosis) DVT or pulmonary embolism (PE))\r\n\r\n          -  Active angina or Class III or IV Congestive Heart Failure (CHF) (New York Heart\r\n             Association CHF Functional Classification System) or clinically significant cardiac\r\n             disease within 12 months of study enrollment, including myocardial infarction,\r\n             unstable angina, grade 2 or greater peripheral vascular disease, congestive heart\r\n             failure, uncontrolled hypertension, or arrhythmias not controlled by outpatient\r\n             medication.\r\n\r\n          -  Major surgery within 4 weeks of study enrollment\r\n\r\n          -  Women who are pregnant (confirmed by positive pregnancy test) or lactating\r\n\r\n          -  Known positive test for human immunodeficiency virus (HIV), hepatitis C, or hepatitis\r\n             B surface antigen.\r\n\r\n          -  Active infection requiring treatment with systemic (intravenous or oral)\r\n             anti-infectives (antibiotic, antifungal, or antiviral agent) within 72 hours of\r\n             screening.\r\n\r\n          -  History of eye surgery within 6 months, presence of cataracts or other ocular\r\n             disorders significantly affecting vision\r\n      ","sponsor":"Agensys, Inc.","sponsor_type":"Industry","conditions":"Carcinoma, Renal Cell|Renal Cell Carcinoma of Papillary Histology|Renal Cell Carcinoma With Clear Cell Histology|Renal Cell Carcinoma With Non-Clear Cell Histology","interventions":[{"intervention_type":"Drug","name":"Drug: AGS-16C3F","description":"intravenous (IV) infusion"}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of Adverse Events","time_frame":"24 months"},{"outcome_type":"secondary","measure":"Pharmacokinetic profile for total antibody (TAb), antibody drug conjugate (ADC), and monomethyl auristatin F (MMAF): Ceoi or Cmax, Ctrough, Tmax, AUCτ, t1/2, CL, and Vss","time_frame":"Days 1, 2, 3, 4, 8, 15, 22, 43, 64, 65, 66, 67, 71, 78, and 92","description":"Concentration at end of infusion (Ceoi) or maximum observed concentrations (Cmax), Trough concentration (Ctrough), time to maximum concentration (Tmax), partial area under the serum concentration-time curve (AUCτ), terminal or apparent half-life (t1/2), systemic clearance (CL), and volume of distribution at steady state (Vss)"},{"outcome_type":"secondary","measure":"Incidence of antidrug antibody formation to human native antibody (AGS-16C) and antibody drug conjugate (AGS-16C3F)","time_frame":"24 months"},{"outcome_type":"secondary","measure":"Tumor response: objective response rate","time_frame":"24 months","description":"Determined from the subjects' best response and will include complete response (CR) and partial response (PR)"},{"outcome_type":"secondary","measure":"Tumor response: disease control rate","time_frame":"24 months","description":"Determined from the subjects' best response will include complete response (CR) partial response (PR), and stable disease (SD)"},{"outcome_type":"secondary","measure":"Tumor response: Changes in bone scans","time_frame":"Baseline, Week 13 and every 12 weeks thereafter"}]}
{"nct_id":"NCT02921711","start_date":"2012-06-30","enrollment":90,"brief_title":"TRAIL: Treatment of Intracranial Aneurysms With LVIS System","official_title":"TRAIL: Treatment of Intracranial Aneurysms With LVIS System","primary_completion_date":"2016-04-30","study_type":"Observational [Patient Registry]","rec_status":"Completed","completion_date":"2016-04-30","last_update":"2018-05-17","description":"A prospective, multicenter, observational assessment of the safety and effectiveness of the LVIS device in the treatment of wide necked intracranial aneurysms.","other_id":"TRAIL","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients aged minimum of 18 years with an intracranial aneurysm in whom stent-assisted\r\n        coiling has been determined to be the appropriate treatment strategy.","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patient or patient's legally authorized representative has been informed about the\r\n             confidentiality of the study and has agreed to the collection of his/her personal data\r\n\r\n          2. Patient has a ruptured or unruptured intracranial aneurysm for which:\r\n\r\n               -  The parent artery has a diameter  2.0mm and  4.5 mm;\r\n\r\n               -  The aneurysm neck size is  4mm or its dome-to-neck ratio is < 2 (wide neck)\r\n\r\n               -  Endovascular treatment with coils and one or more LVIS devices has been\r\n                  determined necessary for the patient by the multidisciplinary team\r\n\r\n          3. Patient is aged  18 years\r\n\r\n          4. Patient presents with a WFNS score between 0 and 3\r\n\r\n          5. Patient has agreed to attend follow-up appointments\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. The use of an endovascular stent other than LVIS has been determined necessary\r\n\r\n          2. Patient presents with medical or surgical co-morbidities limiting his/her life\r\n             expectancy to less than one year\r\n\r\n          3. Patient has a contraindication to platelet inhibition treatment\r\n\r\n          4. Patient requires retreatment of an aneurysm previously treated with a stent\r\n\r\n          5. Patient is pregnant\r\n\r\n          6. Patient has multiple aneurysms to be treated in one procedure\r\n      ","sponsor":"Microvention-Terumo, Inc.","sponsor_type":"Industry","conditions":"Intracranial Aneurysms","interventions":[{"intervention_type":"Device","name":"Device: LVIS","description":"Low-profile Visualized Intraluminal Support device"}],"outcomes":[{"outcome_type":"primary","measure":"Anatomical stability of aneurysm treatment compared to the initial occlusion rate of the aneurysm","time_frame":"6 months"},{"outcome_type":"primary","measure":"Anatomical stability of aneurysm treatment compared to the initial occlusion rate of the aneurysm","time_frame":"18 months"},{"outcome_type":"primary","measure":"Retreatment rate","time_frame":"6 months"},{"outcome_type":"primary","measure":"Retreatment rate","time_frame":"18 months"},{"outcome_type":"primary","measure":"Morbidity rate","time_frame":"6 months"},{"outcome_type":"primary","measure":"Morbidity rate","time_frame":"18 months"},{"outcome_type":"primary","measure":"Mortality rate","time_frame":"6 months"},{"outcome_type":"primary","measure":"Mortality rate","time_frame":"18 months"}]}
{"nct_id":"NCT01677936","start_date":"2012-06-30","phase":"Phase 4","enrollment":51,"brief_title":"Study of Raisins Versus Alternative Snacks in Patients With Type 2 Diabetes Mellitus","official_title":"A Randomized, Unblinded, Single Research Site, Comparator Study of Raisins Versus Alternative Snacks on Glycemic Control and Other Cardiovascular Risk Factors in Patients With Type 2 Diabetes Mellitus","primary_completion_date":"2013-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-01-31","last_update":"2014-04-23","description":"The objective of this study is to compare the effects of Raisins three times per day versus alternative snacks three times per day on blood sugar control and cardiovascular risk factors (weight, waist circumference, blood pressure, cholesterol levels) in patients with Type 2 Diabetes Mellitus. These effects will be studied over a 12 week period.","other_id":"Raisin DM 002","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Are generally healthy men and women older than 18 years of age\r\n\r\n          -  Are willing and able to undergo an informed consent process\r\n\r\n          -  Have medical history of Type 2 Diabetes Mellitus\r\n\r\n          -  Have hemoglobin A1c 67.5 - 10%\r\n\r\n          -  Have body mass index (BMI) 25.0 to 39.9 kg/m2\r\n\r\n          -  Have blood pressure > 100 mmHg systolic or > 70 mmHg diastolic\r\n\r\n          -  Are willing and able to perform self-glucose monitoring throughout the study\r\n\r\n          -  Are willing to fast before study visits\r\n\r\n          -  Are willing and able to bring in their morning anti-diabetes mellitus drugs to study\r\n             visits\r\n\r\n          -  Women must be of non-childbearing potential defined as postmenopausal for at least 2\r\n             years or surgically sterile (i.e. bilateral tubal ligation, bilateral oophorectomy, or\r\n             hysterectomy).\r\n\r\n          -  If not menopausal or surgically sterile, then women of child-bearing potential must be\r\n             willing to use:\r\n\r\n               -  oral contraceptives and another acceptable form of birth control, or\r\n\r\n               -  double barrier birth control methods such as condom or occlusive cap (e.g.\r\n                  diaphragm or cervical/vault caps) plus spermicidal agent (e.g. foam, gel, film,\r\n                  cream, suppository).\r\n\r\n          -  Are willing to notify the research staff of any change in their medical health &\r\n             concomitant medications/supplements during the course of the clinical trial\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Intolerance, dislike, or unwillingness to consume raisins or any of the comparator\r\n             snacks and affiliated ingredients\r\n\r\n          -  History of greater than one drug allergy\r\n\r\n          -  History of greater than one \"food allergy\"\r\n\r\n          -  Change in anti-diabetes mellitus medication within 3 months prior to screening visit\r\n\r\n          -  Change in blood pressure and/or lipid-altering medications within 1 month of screening\r\n             visit\r\n\r\n          -  Plans to change current anti-diabetes mellitus, blood pressure, or lipid-altering\r\n             medications during course of the study\r\n\r\n          -  Unwilling to maintain current anti-diabetes mellitus, blood pressure, or\r\n             lipid-altering medications and their doses during the course of the study\r\n\r\n          -  History of clinically significant diabetes mellitus complications, that in the opinion\r\n             of the investigator, may interfere with the successful completion of the trial\r\n\r\n          -  History of clinically significant diabetes mellitus kidney disease (e.g. clinically\r\n             significant proteinuria)\r\n\r\n          -  History of severe high or low blood sugars within the past year, as per Investigator\r\n             discretion\r\n\r\n          -  History of severe high or low blood sugars requiring hospitalization at any time in\r\n             the past\r\n\r\n          -  Subjects are excluded if within the past 6 months, they have history of myocardial\r\n             infarction, acute coronary syndrome, stroke, or any cardiac / vascular surgical\r\n             procedure (e.g. atherosclerotic coronary heart disease by-pass, carotid surgery,\r\n             peripheral vascular by-pass, stent placement, pacemaker placement, etc.), unstable\r\n             angina, or alterations in treatment of stable angina\r\n\r\n          -  Subjects are excluded if at any time in the past, they have history of clinically\r\n             significant ventricular or atrial dysrhythmias\r\n\r\n          -  Subjects are excluded if at any time in the past, they have history of New York Heart\r\n             Association (NYHA) functional heart failure of Class III or greater, defined as: CLASS\r\n             III: Marked limitation of physical activity, comfortable at rest, but less than\r\n             ordinary activity causes fatigue, palpitations or dyspnea, CLASS IV: Unable to carry\r\n             out any physical activity without discomfort, symptoms of cardiac insufficiency at\r\n             rest, if any physical activity is undertaken, discomfort is increased\r\n\r\n          -  Subjects are excluded if at any time in the past, they have history of or known\r\n             increases in QTc\r\n\r\n          -  History of seizures in the past year\r\n\r\n          -  Is pregnant, breastfeeding or plans to become pregnant during the course of the\r\n             clinical trial\r\n\r\n          -  Major surgical procedure within 30 days prior to visit #1 (i.e. day of signing of the\r\n             informed consent document), or current plans to have a major surgical procedure during\r\n             study participation or 30 days following completion of all study related procedures\r\n\r\n          -  History of gastrointestinal malabsorption (e.g. uncontrolled crohn's disease, etc.) or\r\n             history of a gastric bypass or other diversional bariatric surgery. Gastric banding\r\n             procedure is also exclusionary if adjusted within 30 days prior to visit #1 (i.e. day\r\n             of signing the informed consent document), or a reasonable chance of having a gastric\r\n             banding adjustment during the course of the study\r\n\r\n          -  History of ongoing malignancy. History of malignancy is acceptable for eligibility if\r\n             successfully treated, with no evidence of persistence or recurrence of the malignancy\r\n             within 5 years of visit #1 (i.e. day of signing the informed consent document) or\r\n             basal carcinoma of the skin and \"in situ\" cancer of the cervix successfully treated 30\r\n             days prior to visit #1\r\n\r\n          -  History of organ transplant.\r\n\r\n          -  History of drug (licit or illicit) or alcohol abuse/addiction within 5 years of visit\r\n             #1 (i.e. day of signing the informed consent document)\r\n\r\n          -  Routinely consumes more than 2 units of alcohol per day. A unit of alcohol is defined\r\n             as a 12 ounce (350 ml) beer, 5 ounce (150 ml) wine, or 1.5 ounce (45 ml) of 80-proof\r\n             alcohol for mixed drinks.\r\n\r\n          -  History of clinically significant heart, vascular, hematologic, orthopedic,\r\n             rheumatologic, muscle, brain, neurologic (e.g. dementia, uncontrolled seizure\r\n             disorder, etc.) , gastrointestinal (such as chronic hepatitis B or C, malabsorptive\r\n             intestinal diseases such as uncontrolled crohn's disease, ulcerative colitis, severe\r\n             irritable bowel syndrome, other significant gastrointestinal diseases that may\r\n             interfere with study participation and/or results), endocrine (uncontrolled hyper or\r\n             hypothyroidism), ophthalmologic, infectious (e.g. human immunodeficiency virus,\r\n             tuberculosis, etc.) immunologic, nephrologic, pulmonary (e.g. poorly controlled\r\n             asthma, poorly controlled chronic obstructive pulmonary disease, dyspnea, etc.),\r\n             dermatologic, reproductive, psychiatric (e.g. bipolar disorder, schizophrenia,\r\n             borderline personality disorder, etc.) disorders, or any other conditions that would\r\n             present unacceptable risk to study subjects, compromise the acquisition or\r\n             interpretation of study data, or otherwise interfere with the study subject's\r\n             participation in the study.\r\n\r\n          -  History of severe or uncontrolled depression based upon the opinion of the Principal\r\n             Investigator.\r\n\r\n          -  Blood pressure >160 mmHg systolic or >100 mmHg diastolic.\r\n\r\n          -  Weight change (increase or decrease) of > 5 pounds in 2 months (by history) prior to\r\n             visit 1\r\n\r\n          -  Bradycardia defined as pulse less than 50 beats/minute\r\n\r\n          -  History of clinically significant anemia\r\n\r\n          -  Fasting serum lipoprotein values of: LDL-cholesterol, >160 mg/dl or triglycerides,\r\n             >500 mg/dl (exclusionary during screening only)\r\n\r\n          -  Creatinine level on screening > 1.5 times the upper range of normal.\r\n\r\n          -  Liver enzymes on screening > 2 times the upper limits of normal\r\n\r\n          -  Potassium level above the upper range of normal upon screening (one repeat lab would\r\n             be permitted if the initial elevated potassium level is thought possibly due to\r\n             laboratory error)\r\n\r\n          -  Known laboratory abnormalities prior to randomization which Principal Investigator\r\n             deems may pose an unacceptable risk, compromise acquisition or interpretation of study\r\n             data, or otherwise interfere with the study subject's participation in the study\r\n\r\n          -  Known positive testing for hepatitis B surface antigen, hepatitis C antibody, active\r\n             hepatitis A immunoglobulin M, or human immunodeficiency virus (HIV)\r\n\r\n          -  Current or past use of insulin\r\n\r\n          -  Use of systemic corticosteroids (intravenous, subcutaneous, intra-articular). Inhaled\r\n             and intranasal corticosteroids are permitted.\r\n\r\n          -  Use of antiobesity/weight maintenance drug therapies at initial study visit, or within\r\n             2 months of the initial study visit.\r\n\r\n          -  Use of digoxin or other cardiac antidysrhythmic drugs\r\n\r\n          -  Use of anticoagulants (such as warfarin, Coumadin)\r\n\r\n          -  Use of dietary supplements are acceptable, as long as the supplement intake was\r\n             constant for one month prior to visit 1, and the study participant plans to continue\r\n             the same supplement at the same dose throughout the study\r\n\r\n          -  Known medical history of clinical significance, or any other conditions that would\r\n             present unacceptable risk to study subject, compromise the acquisition or\r\n             interpretation of study data, or otherwise interfere with the study subject's\r\n             participation in the study as per discretion of the Principal Investigator.\r\n\r\n          -  Is an employee or immediate family member of the research staff.\r\n\r\n          -  Donated blood within 2 months prior to study entry, or plans to donate blood during\r\n             the course of this study.\r\n\r\n          -  Anticipation of a significant change in job, job duties, or job work hours, which\r\n             might impair their ability and willingness to undergo study-related procedures under\r\n             the timelines specified by protocol, and otherwise impede their completion of the\r\n             study.\r\n\r\n          -  Anticipation of or a reasonable likelihood of moving away from the research site,\r\n             wherein such a move might impair their ability and willingness to undergo\r\n             study-related procedures within the timelines specified by protocol, or otherwise\r\n             impede their completion of the study.\r\n\r\n          -  Anticipation of or a reasonable likelihood of vacations or other times away from home\r\n             which might impair their ability and willingness to undergo study-related procedures\r\n             within the timelines specified by the study protocol, or otherwise impede their\r\n             completion of the study.\r\n\r\n          -  Planned or anticipated major changes in lifestyle health practices, except as allowed\r\n             by study protocol.\r\n\r\n          -  Treatment with an investigational product or an investigational device within 30 days\r\n             prior to visit #1 (i.e. day of signing the informed consent document) and have no\r\n             plans to potentially start any investigational product or use an investigational\r\n             device during or 30 days after the study subject completes all study related\r\n             procedures.\r\n\r\n          -  Reasonable life-expectancy of less than 2 years.\r\n\r\n          -  Any other reason, if in the opinion of the Investigator, the individual study subject\r\n             is not appropriate, or suitable for participation in the clinical trial.\r\n      ","sponsor":"Louisville Metabolic and Atherosclerosis Research Center","sponsor_type":"Other","conditions":"Diabetes Mellitus","interventions":[{"intervention_type":"Other","name":"Other: Raisins","description":"1 oz, 90 calorie packages of raisins will be administered to subjects in the raisin treatment arm"},{"intervention_type":"Other","name":"Other: Snacks","description":"100 calorie snack packs will be administered to the subjects in the snack group"}],"outcomes":[{"outcome_type":"primary","measure":"Postprandial Glucose Levels","time_frame":"12 weeks","description":"Raisins versus snacks: percent change in postprandial glucose levels at week 12"},{"outcome_type":"secondary","measure":"Systolic Blood Pressure","time_frame":"12 weeks.","description":"Raisins versus snacks: mmHg change in systolic blood pressure at week 12"}]}
{"nct_id":"NCT02002039","start_date":"2012-06-30","phase":"Phase 2/Phase 3","enrollment":100,"brief_title":"Neuroprotective Role of Erythropoietin in Perinatal Asphyxia","official_title":"Erythropoietin in Perinatal Asphyxia: A Randomized Placebo Controlled Trial","primary_completion_date":"2016-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-06-30","last_update":"2016-10-14","description":"Whether Erythropoietin improves the neurological outcomes of neonates with perinatal asphyxia.","other_id":"Erythropoietin 01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","maximum_age":6,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Babies with severe perinatal asphyxia with moderate to severe HIE in the immediate\r\n             neonatal period\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Babies with congenital malformations\r\n\r\n          -  Small for gestational age babies\r\n\r\n          -  Babies with chromosomal anomalies\r\n      ","sponsor":"Sheri Kashmir Institute of Medical Sciences","sponsor_type":"Other","conditions":"Perinatal Asphyxia","interventions":[{"intervention_type":"Drug","name":"Drug: Erythropoietin","description":"500 units /kg /day every other day for 5 doses"}],"outcomes":[{"outcome_type":"primary","measure":"Death or moderate or severe disability at 18-22 months of age","time_frame":"18-22 months"},{"outcome_type":"secondary","measure":"Disability","time_frame":"18-22 months","description":"Severe disability was defined as GMFCS grade of level 3-5, hearing impairment requiring hearing aids, bilateral cortical visual impairment with no useful vision or Bayley Mental Development Index Score less than 70. Moderate disability was defined as Bayley Mental Developmental Index Score between 70-84 and any one of the following criteria: GMFCS grade of level 2, hearing impairment with no amplification or persistent seizure disorder."},{"outcome_type":"secondary","measure":"Bayley psychomotor development index","time_frame":"18-22 months months"},{"outcome_type":"secondary","measure":"Hearing loss at 18-22 months","time_frame":"18-22 months"}]}
{"nct_id":"NCT01843439","start_date":"2012-06-30","phase":"N/A","enrollment":360,"brief_title":"Effects of Multidisciplinary Interventions in Elderly Asthma Patients With Risk of Acute Exacerbation","primary_completion_date":"2016-06-30","study_type":"Interventional","rec_status":"Unknown status","last_update":"2013-04-30","description":"We want to examine the effect of multidisciplinary interventions in asthma patients who had experienced acute exacerbation of asthma. In our previous observational studies, elderly asthma patients had a some distinct features such as impairment of cognitive function, deficiency of micronutrient and absence of caregiver compared with young adult asthmatics. We wanted to evaluate whether the long-term course of asthma could be modified by intervening deficienies which were found in elderly patiensts. So, we designed a interventional study to correct above risk factors in elderly asthma patients, which could be aggravating their asthma. Followings are our specific multidiciplinary items that we want to correct. 1. popularize and educate the asthma action plan 2. run a emergency call system for acute exacerbation 3. educate the proper techniques using inhalers 4. correct the deficiency of magnesium (magnesium 500 mg per day) After 1 years, we will measure the numbers of acute exacerbations, lung function including FEV1 and FEV1/FVC, health-related quality of life and level of serum magnesium in study patients.","other_id":"H-1205-083-410","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  elderly asthma patients who had experienced acute exacerbation of asthma\r\n\r\n             1)aggravations of any of major criteria\r\n\r\n          -  dyspnea\r\n\r\n          -  cough\r\n\r\n          -  wheezing\r\n\r\n          -  increase or purulent changes of sputum\r\n\r\n          -  nocturnal symptoms\r\n\r\n             2)aggravation of more than one of following criteria\r\n\r\n          -  a reduction of forced expiratory volume at one second or peak expiratory flow rate\r\n             more than 20% compared than one's best score\r\n\r\n          -  unscheduled clinic or emergency department visit or admission\r\n\r\n          -  step-up of dose of asthma medications or any intake of systemic steroids\r\n      ","sponsor":"Sang-Heon Cho","sponsor_type":"Other","conditions":"Asthma|Aged","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Magnesium"},{"intervention_type":"Behavioral","name":"Behavioral: Education for asthma action plan"},{"intervention_type":"Behavioral","name":"Behavioral: hot-lines for acute exacerbation of asthma"},{"intervention_type":"Behavioral","name":"Behavioral: Inhaler technique training"}],"outcomes":[{"outcome_type":"primary","measure":"Number of acute exacerbation of asthma","time_frame":"1 year from enrollment","description":"measure the existence of acute exacerbation when they visit the clinic at 3, 6, 12 month after enrollment"},{"outcome_type":"secondary","measure":"Pulmonary function test","time_frame":"1 year after enrollment","description":"measure when subjects visits the clinic at 3, 6, 12 month after enrollment"},{"outcome_type":"secondary","measure":"Asthma control status","time_frame":"one year from enrollment","description":"measure when subjects visit the clinic at 3, 6, 12 month after enrollment"},{"outcome_type":"secondary","measure":"asthma quality of life questionnaire","time_frame":"one year from enrollment","description":"measure when subjects visit the clinic at 3, 6, 12 month after enrollment"},{"outcome_type":"secondary","measure":"serum magnesium level","time_frame":"one year from enrollment","description":"measure when subjects visit the clinic at 3, 6, 12 month after enrollment"}]}
{"nct_id":"NCT04664595","start_date":"2012-06-30","phase":"N/A","enrollment":40,"brief_title":"Requirements of Propofol With Target Controlled Infusions for Supraglottic Airway Devices","official_title":"Requirements of Propofol With Target Controlled Infusions for Supraglottic Airway Devices","primary_completion_date":"2013-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-12-31","last_update":"2021-08-23","description":"to evaluate and compare the effect-site concentration of propofol with the TCI system for second-generation SGA device insertion between the I-gel, Supreme, ProSeal and Laryngeal Tube Suction II. to determine the hemodynamic changes during insertion of supraglottic devices in patients undergoing elective surgery and any complications after device insertion.","other_id":"55-213-08-1-2","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","intervention_model_description":"4 second generation of supraglottic airway device","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  ASA physical status I-III patients.\r\n\r\n          -  Patients 18-70 years old .\r\n\r\n          -  Patients scheduled for general anesthesia for elective non-cardiac surgery with SGA\r\n             devices.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Adults with a potentially difficult airway (cervical spine disease, Mallampati\r\n             classification IV, or a mouth opening less than 2.5 cm.).\r\n\r\n          -  Adults with reactive airway disease.\r\n\r\n          -  Adults with signs of respiratory infection or a plan to remain intubated were excluded\r\n             from the study.\r\n\r\n          -  Excluded patients who had a risk of gastric aspiration or morbid obesity (body mass\r\n             index > 35 kg/m2).\r\n      ","sponsor":"Prince of Songkla University","sponsor_type":"Other","conditions":"Appropriate Affect|Complication of Device Insertion","interventions":[{"intervention_type":"Drug","name":"Drug: Propofol Fresenius","description":"final dose of Propofol (mcg/kg) to reach the target effect-site concentration"}],"outcomes":[{"outcome_type":"primary","measure":"Tolerability of propofol for supragloqtic airway devices insertion","time_frame":"2 years","description":"The effect-site concentration of propofol required to insert supraglottic airway devices."},{"outcome_type":"secondary","measure":"Blood pressure changes from baseline after insertion of supraglottic devices","time_frame":"2 years"}]}
{"nct_id":"NCT01607671","start_date":"2012-06-30","phase":"Phase 1","enrollment":0,"brief_title":"Treatment Study for Ischemic Optic Neuropathy With Opthalmic Timolol Maleate 0.5%","official_title":"Can Urgent Reduction of Intraocular Pressure With Ophthalmic Timolol Improve Recovery From Non-arteritic Anterior Ischemic Optic Neuropathy (NAION): a Randomized Study.","primary_completion_date":"2013-11-30","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2013-11-30","last_update":"2015-05-25","description":"The purpose of this study is to evaluate the feasibility of rapid evaluation and administration of ophthalmic Timolol maleate in the treatment of non-arteritic anterior ischemic optic neuropathy. Secondary goals are to evaluate if such treatment reduces the progression or improves recovery of patients who are randomly assigned to treatment versus standard of care.","other_id":"NAION-001","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":41,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age >40\r\n\r\n          -  Sudden, painless monocular vision loss with edema of the optic disc\r\n\r\n          -  Clinical diagnosis is Non-Arteritic Anterior Ischemic Optic Neuropathy\r\n\r\n          -  Relative Afferent Pupil Defect (RAPD) at first study visit\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Onset of vision loss >48 hours from time of enrollment\r\n\r\n          -  History of Asthma or COPD\r\n\r\n          -  History of Heart Block or Sinus Bradycardia\r\n\r\n          -  Allergy to any beta blocker\r\n\r\n          -  History of Multiple Sclerosis or optic neuropathy\r\n\r\n          -  Active Ocular Inflammation on examination\r\n\r\n          -  Currently being treated for Cancer or systemic vasculitis\r\n\r\n          -  History of Glaucoma or use of medications that lower IOP\r\n\r\n          -  Symptomatic cataract, retinopathy, macular disease or amblyopia in the symptomatic eye\r\n\r\n          -  IOP of <10 at baseline\r\n\r\n          -  Ocular surgery in past three months\r\n\r\n          -  Women who are pregnant, breast-feeding or may become pregnant\r\n\r\n          -  Inability to provide informed consent or follow up at three months\r\n\r\n          -  Currently enrolled in any other study drug trial or previously enrolled in this study\r\n      ","sponsor":"Fraser Health","sponsor_type":"Other","conditions":"Optic Neuropathy, Ischemic|Anterior Ischemic Optic Neuropathy|Ischemic Optic Neuropathy|Optic Neuropathy, Anterior Ischemic","interventions":[{"intervention_type":"Drug","name":"Drug: Timolol maleate","description":"Timolol 0.5% 1 drop twice daily to the effected eye for 4 weeks."}],"outcomes":[{"outcome_type":"primary","measure":"Recruitment Rate of patients during the one year study to assess feasibility of a larger study","time_frame":"12 months","description":"This is to define the feasabilty of the study design for a larger study."},{"outcome_type":"primary","measure":"Number of patients with adverse events","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Change in visual acuity at enrollment and three month follow up using a logMAR scale.","time_frame":"Enrolment, Within 48 hours of enrollment , 1 month, 3 months.","description":"This will evaluate the change in visual acuity as a measure of visual function."},{"outcome_type":"secondary","measure":"Change in the mean deviation of actual versus predicted sensitivity of the visual field.","time_frame":"48 hours after enrollment, 1 month, 3 months","description":"Using a a Haag-Streit Octopus 900 with white on white TOP 30-2 visual field program, the mean deviation will be compared at various time points to assess for improving visual function as it relates to the field of vision."},{"outcome_type":"secondary","measure":"Change in Colour vision as measured by HRR colour plates.","time_frame":"Within 48 hours of enrollment, 1 month, 3 months","description":"The total number of colour plates seen will be counted and compared to baseline as a measure of visual recovery as it effects colour vision."},{"outcome_type":"secondary","measure":"Change in contrast sensitivity will be measured using the Pelli-Robson contrast sensitivity chart.","time_frame":"48 hours from enrollment, 1 month, 3 months.","description":"The Pelli-Robson contrast sensitivity chart is another method to assess visual function. The change in total number of plates seen will be compared at the various time points."}]}
{"nct_id":"NCT03867890","start_date":"2012-06-30","enrollment":580,"brief_title":"Relationship Between Footwear Consumer Behaviour and Lower Extremity Injuries","official_title":"Is Consumer Behaviour Towards Footwear Predisposing for Lower Extremity Injuries in Runners and Walkers? A Prospective Study","primary_completion_date":"2013-04-30","study_type":"Observational","rec_status":"Completed","completion_date":"2013-04-30","last_update":"2019-03-08","description":"A prospective cohort study was set-up in leisure-time walkers and runners. Potential risk factors in consumer behaviour were obtained by means of a baseline questionnaire related to the acquisition of current walking or running shoes. Information on injuries sustained during a 24 week period after the baseline questionnaire was obtained in 104 runners and 104 walkers using a 2-weekly questionnaire.","other_id":"B670201214347","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","population":"Leisure-time runners and walkers","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  walk or run at least 10 kilometres per week\r\n\r\n          -  maintain a minimal distance of ten kilometres per week, for a period of 24 weeks\r\n\r\n          -  wear one and the same pair of shoes during walking/running activities during this\r\n             period\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  systemic disease, cardiac problems or diabetes\r\n\r\n          -  complaints at the lower extremities in the last two weeks,\r\n\r\n          -  surgery at the lower extremities in the last three years\r\n      ","sponsor":"University Ghent","sponsor_type":"Other","conditions":"Risk Factor|Sports Injury|Footwear","interventions":[{"intervention_type":"Other","name":"Other: no intervention"}],"outcomes":[{"outcome_type":"primary","measure":"injury occurence","time_frame":"24 weeks","description":"self-reported running or walking injury questionnaire"}]}
{"nct_id":"NCT01761981","start_date":"2012-06-30","enrollment":250,"brief_title":"Institutional Registry of Haemorrhagic Hereditary Telangiectasia","official_title":"Institutional Registry of Haemorrhagic Hereditary Telangiectasia","primary_completion_date":"2017-06-30","study_type":"Observational","rec_status":"Unknown status","completion_date":"2017-12-31","last_update":"2015-12-17","description":"The purpose of this study is to create an institutional and population-based registry of Haemorrhagic Hereditary Telangiectasia with a prospective survey based on epidemiological data, risk factors, diagnosis, prognosis, treatment, monitoring and survival. This study will also describe the occurrence of Haemorrhagic Hereditary Telangiectasia in the population of HIBA in the Central Hospital, as well as the characteristics of clinical presentation and evolution.","other_id":"1900","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","population":"Patients with Haemorrhagic Hereditary Telangiectasia","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patients with HHT defined.\r\n\r\n          2. Followed in Unidad HHT of Hospital Italiano de Buenos Aires.\r\n\r\n        Exclusion Criteria:\r\n\r\n        1. Denied to participated in the registry or inform consent process.\r\n      ","sponsor":"Hospital Italiano de Buenos Aires","sponsor_type":"Other","conditions":"Haemorrhagic Hereditary Telangiectasia","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"morbidity","time_frame":"1 year","description":"Control visit every three month"}]}
{"nct_id":"NCT01681654","start_date":"2012-06-30","phase":"N/A","enrollment":60,"brief_title":"Exercise and Nutrition for Head and Neck Cancer Patients","official_title":"Exercise and Nutrition for Head and Neck Cancer Patients: A Patient Oriented, Clinic-Supported Randomized Controlled Trial","primary_completion_date":"2014-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-12-31","last_update":"2016-10-26","description":"Research on physical activity and nutrition interventions aimed at positively impacting symptom management, treatment-related recovery and quality of life has largely excluded head and neck cancer populations. This translates into a lack of clinical programming available for these patient populations. Head and neck cancer patients deal with severe weight loss, with upwards of 70% attributed to lean muscle wasting, leading to extended recovery times, decreased quality of life (QoL), and impaired physical functioning. To date, interventions to address body composition issues have focused solely on diet, despite findings that nutritional therapy alone is insufficient to mitigate changes. A combined physical activity and nutrition intervention, that also incorporates important educational components known to positively impact behaviour change, is warranted for this population. Pilot work suggests that there is large patient demand and clinic support from the health care professionals for a comprehensive program. Therefore, the purpose of the present study is to examine the impact of timing of a 12-week PA and nutrition intervention (either during or following treatment) for HN cancer patients on body composition, recovery, serum inflammatory markers and quality of life. In addition, the investigators will examine the impact of a 12-week maintenance program, delivered immediately following the intervention, on adherence, patient-reported outcomes (i.e., management of both physical and psychosocial treatment-related symptoms and side-effects), as well as return to work. The investigators hypothesize that (1) patients who are randomized to the intervention at treatment start will experience improved symptom management and decreased lean body composition changes, directly improving recovery and QoL; (2) patients who receive a maintenance support program will have better long-term adherence and therefore superior treatment-related symptom management, physical and psychosocial functioning; and (3) return to work indices will improve and healthcare utilization costs will be lower in the participants who receive the immediate intervention (vs. delayed) as well as in those who receive the maintenance program (vs. no maintenance). This research will facilitate advancements in patient wellness, survivorship, and autonomy, and carve the path for a physical activity and wellness education model that can be implemented in other cancer centers.","other_id":"ENHANCE10001991","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Over 18 Years of Age\r\n\r\n          -  Has received a diagnosis of nasopharyngeal, oropharyngeal or hypopharyngeal cancer\r\n\r\n          -  Will receive radiation as part of treatment plan\r\n\r\n          -  Able to walk without assistance\r\n\r\n          -  Received clearance for exercise from treating oncologist\r\n\r\n          -  Lives in Calgary, Alberta area\r\n\r\n          -  Can speak and write English\r\n\r\n          -  Is interested in participating in the study\r\n      ","sponsor":"University of Calgary","sponsor_type":"Other","conditions":"Cancer of Head and Neck","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Lifestyle Intervention","description":"Participants in the Lifestyle Intervention will receive a 12-week individualized exercise and dietary program based on their exercise assessment and dual energy x-ray absorptiometry (DXA) scan results, will attend twice weekly group exercise classes, and perform their individualized at-home program an additional two times per week. In addition, participants will be required to attend six education sessions during the 12-week intervention."},{"intervention_type":"Behavioral","name":"Behavioral: Maintenance Intervention","description":"Patients randomized to receive the Maintenance Program Intervention following treatment will receive a Survivorship Care Plan outlining their physical activity, dietary, and health behaviour progress throughout the program, future goals, individualized maintenance strategies, and optional drop-in exercise sessions."}],"outcomes":[{"outcome_type":"primary","measure":"Change from Baseline in Body Composition","time_frame":"At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis","description":"DXA Scan will be used to assess body composition"},{"outcome_type":"secondary","measure":"Quality of Life","time_frame":"At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis","description":"Quality of Life will be assessed using the Functional Assessment of Cancer Therapy- Anemia module (FACT-AN), and the NCCN-FACT Fact Head/Neck Symptom Index-22 (FHNSI-22)."},{"outcome_type":"secondary","measure":"Physical Activity Behaviour","time_frame":"At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis","description":"Physical activity will be assessed using Godin's (Godin, 1985) leisure score index (LSI) of the GLTEQ (Godin Leisure Time Exercise Questionnaire)."},{"outcome_type":"secondary","measure":"Smoking History","time_frame":"At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis","description":"Smoking history will be assessed by a self report questionnaire which will classify patients as non-smokers, former smokers and current smokers."},{"outcome_type":"secondary","measure":"Depression","time_frame":"At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis","description":"Depression will be assessed using the Center for Epidemiological Studies on Depression Scale (CES-D)."},{"outcome_type":"secondary","measure":"Karnofsky Performance Score (KPS)","time_frame":"At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis","description":"The Karnofsky Performance Score (KSP) will be used to measure the participant's general ability to accomplish tasks of daily-living and overall well-being."},{"outcome_type":"secondary","measure":"Inflammatory Markers","time_frame":"At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis","description":"Inflammatory factors will be evaluated as they are associated with cancer cachexia and muscle wasting and may be modified by exercise (Seruga et al., 2008; Baldwin, 2011). An overnight fasted blood draw will be collected at baseline, 3 months post diagnosis, 6 months post diagnosis, 9 months post diagnosis, and 12 months post diagnosis. Serum inflammatory cytokine concentrations will be assessed in-house (Dr. Raylene Reimer's laboratory) according to our established protocols. TNF, IL-6, IL-1, IL-8 and C-reactive protein will be quantified using Milliplex Human Cytokine kits (Millipore, Billerica, MA). Plate reading will be provided as a fee-for service through Eve Technologies Inc. (Calgary, AB)."},{"outcome_type":"secondary","measure":"Cancer related Symptom Management","time_frame":"At baseline (diagnosis) and then 3, 6, 9, 12 months post diagnosis & every week before and after class during the 12 week intervention","description":"Participants will complete the ESAS bi-weekly, before and after class. The ESAS is a valid and reliable assessment tool to evaluate the nine more common symptoms experienced by cancer patients (Chang et al., 2000)."},{"outcome_type":"secondary","measure":"Diet Behaviour - 3 Day food record","time_frame":"At baseline (diagnosis) and 4 & 8 weeks, 3, 6, 9, 12 months post diagnosis.","description":"The 3-Day Diet Record is said to be the most accurate for mean macronutrient content and appropriate for use in studies where subjects may consume a wide variety of foods (American Dietetics Association / Dietitians Canada, 2000). Participants are instructed to record their daily consumption over a period of three days, one of which must be a weekend day. Written instructions and a sample entry are provided to increase accuracy of the daily record."},{"outcome_type":"secondary","measure":"Diet Behaviour: PG-SGA","time_frame":"At baseline (diagnosis), each week during radiation treatment (6.5 weeks in duration), and 3, 6, 9, 12 months post diagnosis","description":"The PG-SGA assessment tool has been show to improve treatment outcomes, decrease side-effects, and improve weight-management in cancer patients, and therefore will be used weekly to assess and identify malnutrition among patients (McMahon et al., 2000; Doyle et al., 2006)."},{"outcome_type":"secondary","measure":"Health related Fitness Measures - Resting Heart Rate","time_frame":"At baseline (diagnosis), and 3, 6, 9, 12 months post diagnosis.","description":"Resting heart rate will be measured by palpating the radial artery and taking a 15 second count as per the CPAFLA protocol (CPAFLA, 2003)."},{"outcome_type":"secondary","measure":"Health Related Fitness Outcome - Blood Pressure","time_frame":"At baseline (diagnosis), and 3, 6, 9, 12 months post diagnosis.","description":"A resting blood pressure (mmHg) will be measured in duplicate on the left arm using a sphygmomanometer and stethoscope using standardized procedures (CPAFLA, 2003)."},{"outcome_type":"secondary","measure":"Health Related Fitness Outcome - 6 minute walk test","time_frame":"At baseline (diagnosis), and 3, 6, 9, 12 months post diagnosis.","description":"The six-minute walk test (6MWT) will be used to assess changes in functional aerobic capacity. Using the standardized protocol, participants will be asked to walk as far as they can around a 400-meter track for six minutes [43]. The point reached at 6 minutes will be marked and measured to the nearest 0.5 meter. Rating of perceived exertion (Borg scale) will be completed immediately after completion of the functional aerobic capacity test."},{"outcome_type":"secondary","measure":"Health Related Fitness Outcome - Grip Strength","time_frame":"At baseline (diagnosis) and 3, 6, 9, and 12 months post diagnosis.","description":"Muscular strength will be assessed using a combined grip strength of the right and left hands will also be assessed using a hand dynamometer. A sum will be determined in kilograms from the best score of 2 trials recorded for each hand according to the CPAFLA protocol."},{"outcome_type":"secondary","measure":"Health Related Fitness Outcome - Lower Body Strength","time_frame":"At baseline (diagnosis), and 3, 6, 9, and 12 months post diagnosis","description":"Lower body strength will be assessed using a 30-second sit to stand test. The number of times participants can stand from a seated position in 30-second will be examined."},{"outcome_type":"secondary","measure":"Health Related Fitness Outcome - Flexibility","time_frame":"At baseline (diagnosis) and 3, 6, 9, and 12 months post diagnosis","description":"Flexibility will be assessed by a trunk forward flexion sit-and-reach test using a Wells-Dillon flexometer. The test will follow a standard protocol, with two trials allowed and the highest score to the nearest 0.5 cm recorded."},{"outcome_type":"secondary","measure":"Health Related Fitness Outcome - Balance","time_frame":"At baseline (diagnosis), and 3, 6, 9, and 12 months post diagnosis.","description":"Balance will be assessed using a static balance test. The test requires the participant to balance on one foot and then the other as long as they can (length of time to a maximum of 45 seconds) while standing on a 2.54 by 2.54 by 30.5 cm base using a standardized protocol, reported by Fleishman."}]}
{"nct_id":"NCT01958346","start_date":"2012-06-30","phase":"N/A","enrollment":78,"brief_title":"New Maneuver to Facilitate Fiberoptic Intubation for Difficult Airway","official_title":"New Maneuver to Facilitate Fiberoptic Intubation for Difficult Airway: A Prospective, Randomized Study","primary_completion_date":"2013-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-11-30","last_update":"2016-09-12","description":"We propose the additional technique of lingual traction or \"tongue pulling\" in conjunction with use of the flexible fiberoptic bronchoscope for facilitating successful first attempts at and decreasing time to intubation of the difficult airway and rescuing otherwise failed intubation attempts. Induction of general anesthesia causes relaxation and approximation of the soft palate, base of the tongue, epiglottis, and posterior pharyngeal wall, creating unfavorable anatomic changes in the pharynx for successful intubation. The use of lingual traction can assist in diminishing these problems by clearing the tongue away from the soft palate and uvula and lifting the epiglottis from the posterior pharyngeal wall, especially in the unanticipated difficult airway patient.","other_id":"Pro00008289","allocation":"Randomized","intervention_model":"Parallel Assignment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  > 18 years old\r\n\r\n          -  With ASA (American Society of Anesthesiologists) physical status I-III\r\n\r\n          -  With anticipated difficult airway\r\n\r\n          -  Scheduled for elective surgery requiring orotracheal intubation (populations such as\r\n             elective hip and knee arthroplasty patients)\r\n\r\n          -  Provide written consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  With (American Society of Anesthesiologists) ASA physical status IV\r\n\r\n          -  Pregnant\r\n\r\n          -  Require rapid-sequence induction\r\n\r\n          -  Require a non-standard tracheal tub\r\n\r\n          -  Unable to provide written consent\r\n\r\n          -  At risk for pulmonary aspiration of gastric content\r\n      ","sponsor":"Enrico Camporesi","sponsor_type":"Other","conditions":"Anticipated Difficult Airway","interventions":[{"intervention_type":"Other","name":"Other: Lingual Traction","description":"The tongue pulling maneuver consists of grasping the tongue with 4x4cm gauze and gently pulling the tongue out until resistance is met."},{"intervention_type":"Other","name":"Other: Sham","description":"Standard of care fiberoptic intubation without any additional experimental maneuvers"},{"intervention_type":"Device","name":"Device: Fiberoptic Intubation"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants With Successful Intubations on First Attempt; Grade(s) Were Not Measured.","time_frame":"At Intubation"},{"outcome_type":"secondary","measure":"Sore Throat Grade on First Postoperative Day","time_frame":"Postoperative day one","description":"Patients will be asked to rate their sore throat qualitatively as none, mild, moderate, or severe"}]}
{"nct_id":"NCT01846195","start_date":"2012-06-06","phase":"N/A","enrollment":60,"brief_title":"Evaluation of the Zynex Blood Volume Monitor in Healthy Adult Patients During a Blood Draw","official_title":"Clinical Evaluation of the Zynex Blood Volume Monitor (CM-1500) in Healthy Adult Patients During a Blood Draw","primary_completion_date":"2013-03-20","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-03-20","last_update":"2021-07-21","description":"Non-invasive monitoring to measure changes in blood volume.","other_id":"Zynex500","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":35,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy volunteers\r\n\r\n          -  Between 18-35 years of age\r\n\r\n          -  Weight between 130-200 pounds\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Known cardiac disease\r\n\r\n          -  Recent caffeine intake\r\n\r\n          -  Tobacco use in the (4) hours prior to screening\r\n\r\n          -  Infection\r\n\r\n          -  Pregnancy\r\n\r\n          -  Hemoglobin <13.5 g/dl\r\n      ","sponsor":"Zynex Monitoring Solutions","sponsor_type":"Industry","conditions":"Blood Loss","interventions":[{"intervention_type":"Device","name":"Device: CM 1500"}],"outcomes":[{"outcome_type":"primary","measure":"Detect by non-invasive monitoring a change in blood volume during a whole blood draw","time_frame":"Acute"},{"outcome_type":"secondary","measure":"Safety to determine non-serious unanticipated adverse device events (UADEs)","time_frame":"Acute","description":"This is a non-significant research and development study. Anticipated adverse effects include localized skin irritation from sensors or mild discomfort from lying supine for a prolonged period of time. All UADEs will be monitored."}]}
{"nct_id":"NCT02469337","start_date":"2012-05-31","phase":"Phase 4","enrollment":40,"brief_title":"Role of Preoperative Carbohydrates Drinks, Dichloroacetate and Exercise on Postoperative Muscle Insulin Resistance","official_title":"Randomized Control Trial of Dichloroacetate, Preoperative Carbohydrate Loading and Moderate Intensity Exercise on Muscle Insulin Resistance After Major Abdominal Surgery","primary_completion_date":"2017-06-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2017-06-30","last_update":"2017-01-05","description":"The aim of the study is to investigate whether preoperative interventions such as carbohydrate drinks, Dichloroacetate and exercise would inhibit or reverse the changes in molecular mechanisms regulating muscle carbohydrate oxidation and postoperative muscle insulin resistance in patients undergoing major abdominal surgery.","other_id":"11/EE/0395","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  All patients over 18 years of age, who are undergoing major elective open abdominal\r\n             surgery will be included in the study. Patients should be able to provide a written\r\n             informed consent to participate in the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who are\r\n\r\n               1. Undergoing emergency surgery\r\n\r\n               2. Suffering from chronic illness, (e.g. diabetes) or other debilitating diseases\r\n\r\n               3. On long term anti-inflammatory drugs, (e.g. NSAIDS, Steroids, immunosuppressant)\r\n\r\n               4. On long term antibiotics\r\n\r\n               5. On Statins\r\n\r\n               6. On full therapeutic dose of anticoagulants, or aspirin >325 mg/day, Clopidrogel\r\n                  >75mg/day\r\n\r\n               7. Suffering from bleeding diathesis\r\n\r\n               8. Unable to give consent\r\n\r\n               9. Pregnant or breastfeeding.\r\n      ","sponsor":"University of Nottingham","sponsor_type":"Other","conditions":"Insulin Resistance","interventions":[{"intervention_type":"Drug","name":"Drug: Dichloroacetate","description":"Dichloroacetate, an analog of acetic acid has been shown to increase the activation of PDC by inhibiting PDK4 in humans. This drug is expected to shift the metabolism of pyruvate from glycolysis and towards oxidative pathway in the mitochondria"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Carbohydrate drinks","description":"preoperative carbohydrate drinks"},{"intervention_type":"Behavioral","name":"Behavioral: Moderate intensity exercise","description":"30 min exercise using a semi-recumbent exercise bike, at about 70% of their age estimated heart rate"}],"outcomes":[{"outcome_type":"primary","measure":"insulin resistance","time_frame":"48 hours after surgery","description":"Relative changes in indices of muscle insulin resistance namely PDC activity, PDK4 mRNA and protein expression."},{"outcome_type":"secondary","measure":"muscle carbohydrate oxidation","time_frame":"48 hours after surgery","description":"Changes in muscle metabolites such as glycogen, glucose, lactate, reflecting the changes in skeletal muscle carbohydrate oxidation."},{"outcome_type":"secondary","measure":"Mitochondrial ATP production","time_frame":"48 hours after surgery","description":"Mitochondrial ATP production rates in patients undergoing major abdominal surgery."}]}
{"nct_id":"NCT01595113","start_date":"2012-05-31","enrollment":41,"brief_title":"Safety Study of Clinical Cell Transplant Therapy Using Hearticellgram-AMI for Patients With Acute Myocardial Infarction","official_title":"A Follow-up Observational Study of Safety of Clinical Trial Conducted With Cell Transplant Therapy Using Hearticellgram-AMI for Patients With Acute Myocardial Infarction","primary_completion_date":"2012-10-31","study_type":"Observational","rec_status":"Completed","completion_date":"2012-12-31","last_update":"2019-02-15","description":"The purpose of this study is to evaluate the safety of the previously conducted clinical trial cell transplant therapy using Hearticellgram-AMI for patients with acute myocardial infarction. This is a follow-up observational study and targeting the subjects who participated in the previously conducted clinical trial.","other_id":"PMC-BD-CT-P-001","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":80,"population":"Subjects agreed to participate in this follow-up observational study among the subjects (80\r\n        patients:40-test group, 40-control group) who participated in the previously conducted\r\n        clinical trial.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients who have elapsed for more than 2 years after onset of acute myocardial\r\n             infarction among the patients who had received cell transplant therapy or drug\r\n             treatment at least once in test and control group on the previously conducted clinical\r\n             trial.\r\n\r\n          -  Subjects agreed to participate in this follow-up study and signed the consent form.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  N/A\r\n      ","sponsor":"Pharmicell Co., Ltd.","sponsor_type":"Industry","conditions":"Acute Myocardial Infarction","interventions":{},"outcomes":{}}
{"nct_id":"NCT01608828","start_date":"2012-05-31","enrollment":120,"brief_title":"Assessing the Functional and Psychosocial Impact of Strabismus in Asian Children Using the AS-20 and IXTQ Questionnaires","official_title":"Assessing the Functional and Psychosocial Impact of Strabismus in Asian Children Using the AS-20 and IXTQ Questionnaires","primary_completion_date":"2014-05-31","study_type":"Observational","rec_status":"Completed","completion_date":"2014-05-31","last_update":"2017-05-03","description":"Studies suggest that strabismus has a negative impact on a person's self-image, interpersonal relationships, emotional and psychosocial state (4-15). There are, however, few such studies based in Asia, and the functional and psycho-social impact of disease is often neglected in our management of strabismus in Singapore. The aim of this pilot study is to measure quality-of-life (QOL) among strabismic children in Singapore so as to better understand the functional and psychosocial issues faced by these children in their daily living. The investigators also hope to evaluate the performance of the Intermittent Exotropia Questionnaire (IXTQ) (2) and Adult Strabismus Quality of Life Questionnaire (AS-20) (1) and to determine if differences between child and parental perceptions exist. 60 children with strabismus presenting to the KKWCH Eye Centre and their parents will be invited to participate in the study and answer questions in 2 Pediatric Eye Disease Investigator Group (PEDIG)-validated questionnaires (i.e. the IXTQ and AS-20). 30 children aged 5-7 years will answer the 12-question IXTQ (5-7 years), while 30 children aged 8-16 years will answer the 12-question IXTQ (8-16 years) and the 20-question AS-20 questionnaires. Their parents will answer the self-administered IXTQ child-proxy (12 questions), IXTQ parental (17 questions) and modified AS20 child-proxy questionnaires (20 questions). For comparison, 60 aged-matched children without strabismus or amblyopia (30 aged 5-7 years, and 30 aged 8-16) and their parents will also be invited to answer similar questionnaires (controls). Results will be analysed question-by-question and then by composite score, and comparison will be made between child and parental-proxy measures, as well as with scores obtained from myopic children. It is hoped, that from this study, we will be able to assess the usefulness of the IXTQ and AS-20 instruments as measures of QOL in strabismic children, and to assess the feasibility of its use in a larger study looking at the impact of strabismus and its treatment in Singaporean children.","other_id":"2012/350/A","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":5,"maximum_age":16,"population":"Children with strabismus","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Children aged 5 to 16 years (inclusive) with strabismus or age-matched controls\r\n             without strabismus/amblyopia\r\n\r\n          2. Any tropia\r\n\r\n          3. Willingness of children or parents willing to complete questionnaires\r\n\r\n          4. Parents with sufficient reading skills to complete the English written IXTQ and AS20\r\n\r\n          5. Parent/guardian able to provide informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Children with poor vision (VA worse than 6/7.5) in either eye\r\n\r\n          2. Children with any ocular, neurological or syndromic problems\r\n\r\n          3. Children with developmental delay or mental impairment\r\n\r\n          4. Children from overseas (not residing in Singapore)\r\n      ","sponsor":"Singapore National Eye Centre","sponsor_type":"Other","conditions":"Strabismus","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Quality of life in Asian children with strabismus","time_frame":"1 year"}]}
{"nct_id":"NCT01583231","start_date":"2012-05-31","phase":"N/A","enrollment":100,"brief_title":"Efficacy of the Brushless Scrub","official_title":"Efficacy of the Brushless Scrub","primary_completion_date":"2013-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-04-30","last_update":"2013-12-19","description":"The aim of this research is to examine if the brushless scrub is effective in reducing bioburden on the hands of the operating room (OR) personnel both with a prewash of one minute prior to scrub and without a prewash prior to scrub, and to compare the bioburden reduction between both methods. Hypothesis I: A soap and water prewash used prior to brushless scrub further decreases bioburden than brushless scrub alone. Hypothesis II: Brushless scrub is effective in reducing the bioburden measured just after the application of the brushless scrub within 20 seconds of application for both groups. Exploratory Hypothesis: We will also compare the bioburden measured before and at 1.5 minutes after application of the brushless scrub for both groups.","other_id":"302192-1","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":19,"maximum_age":62,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Inclusion will consist of all OR personnel and students who scrub for surgical\r\n             procedures.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Exclusion will consist of any OR personnel and students whom do not want to\r\n             participate in the study or those who have not been part of the the routine and\r\n             mandatory training of proper surgical hand hygiene which occurs annually.\r\n      ","sponsor":"Winthrop University Hospital","sponsor_type":"Other","conditions":"Focus of Study: Handwashing","interventions":[{"intervention_type":"Other","name":"Other: Prewash","description":"The intervention will be the addition of the prewash utilizing non-antimicrobial soap and water."}],"outcomes":[{"outcome_type":"primary","measure":"Reduction of bioburden","time_frame":"1.5 minutes after brushless scrub was applied","description":"The procedure of swabbing the participants will be measured by using the RUHOF ATP Complete Contamination Monitoring System."}]}
{"nct_id":"NCT01572246","start_date":"2012-05-31","enrollment":167,"brief_title":"Effects of Monopolar Electrocautery Use During Surgery on Implanted Cardiac Defibrillators","official_title":"Effects of Surgical Monopolar Electrocautery and Optimal Electrosurgery Unit Return Pad Placement on Implantable Cardioverter Defibrillators Protocol","primary_completion_date":"2016-09-14","study_type":"Observational","rec_status":"Completed","completion_date":"2016-09-14","last_update":"2017-02-24","description":"This observational protocol will evaluate the effects of monopolar electrocautery (ME) on implantable cardioverter defibrillators (ICDs) in patients undergoing surgery. ME can cause electromagnetic interference (EMI) leading to ICD damage or inadvertent ICD discharge (shocks). Recommended practice calls for the preoperative reprogramming of ICDs when ME will be used to prevent patients from receiving inadvertent shocks. This requires the presence of someone trained in ICD programming, but a trained person is not always readily available. In this study the investigators will reprogram ICDs prior to surgery according to current practice, but will also record what would have happened had the ICD reprogramming not occurred (\"detection on\" but \"therapy off\"). In addition, the investigators will evaluate the effect of the location of the electrosurgery unit (ESU) return pad on the incidence of EMI. The investigators hypothesize that directing the current return path away from the ICD will result in lower EMI rates than previously described.","other_id":"ISROTH20028","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Subjects with ICDs (including cardiac resynchronization therapy system-defibrillators)\r\n        scheduled for surgery involving ME.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adult individuals of both genders, 18 years of age and older\r\n\r\n          -  For patients undergoing surgery about the waist, previous implantation of a\r\n             functioning Boston Scientific or Medtronic ICD\r\n\r\n          -  For patients undergoing surgery below the waist, previous implantation of a\r\n             functioning Boston Scientific, Medtronic, St. Jude Medical, or Biotronik ICD\r\n\r\n          -  Signed informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Surgery involving the ICD pocket (generator change out procedure)\r\n\r\n          -  Surgery or procedures exclusively involving bipolar electrocautery (such as ophthalmic\r\n             surgery)\r\n\r\n          -  Patients undergoing surgery above the waist with ICDs not manufactured by Medtronic or\r\n             Boston Scientific (other ICDs do not allow reprogramming to allow EMI detection\r\n             without the potential for inadvertent ICD discharge)\r\n      ","sponsor":"Oregon Health and Science University","sponsor_type":"Other","conditions":"Heart Failure|Tachycardia, Ventricular","interventions":[{"intervention_type":"Other","name":"Other: Optimal placement of return pad","description":"The ESU return pad will be placed in an optimal position in order to direct ME current away from the ICD pulse generators."}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of electromagnetic interference (EMI)","time_frame":"During surgery on day of enrollment","description":"Evaluation of occurence of EMI when monopolar electrocautery is used in surgical procedures when the patient has an existing ICD."},{"outcome_type":"secondary","measure":"Incidence of unexpected preoperative ICD-related problems","time_frame":"Up to 6 months prior to date of surgery","description":"Determine the incidence and nature of unexpected preoperative ICD-related problems, such as inadequate pacing or sensing thresholds, battery at or near elective replacement interval, and lead fracture, as detected by preoperative ICD interrogation."}]}
{"nct_id":"NCT01287819","start_date":"2012-05-31","enrollment":200,"brief_title":"Apolipoprotein E Gene and Functional MRI","official_title":"Polymorphisms of Apolipoprotein E Gene and the Presentation of Resting-state Functional MRI","primary_completion_date":"2013-04-17","study_type":"Observational","rec_status":"Completed","completion_date":"2013-04-18","last_update":"2019-09-19","description":"1. Apolipoprotein E gene (ApoE) is the most important genetic factor for Alzheimer disease (AD) and an important genetic factor for outcome of brain injury situations. 2. Function magnetic resonance imaging (fMRI) is a powerful tool for study of both brain regional functions and brain network. 3. Study about genetic contribution on fMRI is an emerging concept, which will help on understanding about how the genetics affecting the brain function.","other_id":"CRC-12-10-04","observational_model":"Case-Control","time_perspective":"Cross-Sectional","sampling_method":"Probability Sample","gender":"All","minimum_age":45,"maximum_age":65,"population":"people aged 45-65 years taking health examination in TMU SHH no cognitive impairment by\r\n        MMSE and AD8 screening","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  people aged 45-65 years without cognitive impairment\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  unable to take APOE genotyping or undergo functional MRI\r\n      ","sponsor":"Taipei Medical University Shuang Ho Hospital","sponsor_type":"Other","conditions":"Dementia","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"amyloid load by amyloid-PET examination","time_frame":"every 5 years","description":"The primary end point of this study is the quantity of amyloid load in brain. The amyloid load will be calculated based on the results of AV45 PET study. The comparison between mTBI and controls will be conducted by ANOVA test. The confounders include vascular risks for AD, such as hypertension, diabetes, and APOE genotypes, education."}]}
{"nct_id":"NCT01606059","start_date":"2012-05-31","phase":"Phase 1","enrollment":30,"brief_title":"Phase 1 Study of DW-0919 & DW-0920 in Healthy Male Volunteers Under Fasting Condition","official_title":"A Randomized, Open Label, 2-treatment, 2-sequence, Cross-over Study to Compare the Safety and Pharmacokinetics of DW-0919 and DW-0920 After Single Oral Administration in Healthy Male Volunteers","primary_completion_date":"2012-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-06-30","last_update":"2016-10-12","description":"The purpose of this study is to evaluate safety and pharmacokinetics of DW-0919 and DW-0920 in healthy male volunteers under fasting condition.","other_id":"DW0919-1003","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":20,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adult males aged 20 to 55 years at screening.\r\n\r\n          -  No significant congenital/chronic disease.\r\n\r\n          -  No symptoms in physical examination.\r\n\r\n          -  Appropriate subjects as determined by past medical history, laboratory tests, serology\r\n             and urinalysis.\r\n\r\n          -  Be able to understand the objective, method of the study, the characteristics of\r\n             investigational drug, and comply with the requirement of the study. Subject must\r\n             provide written informed consent prior to study participation.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of Hyperreactivity with drug ingredients(acetaminophen, tramadol) or opioids.\r\n\r\n          -  History or presence of liver, kidney, or nervous system disease, respiratory\r\n             disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric\r\n             or cognitive disorders.\r\n\r\n          -  History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or\r\n             disorders of absorption, distribution, metabolism, excretion.\r\n      ","sponsor":"Daewon Pharmaceutical Co., Ltd.","sponsor_type":"Industry","conditions":"Healthy","interventions":[{"intervention_type":"Drug","name":"Drug: DW-0920","description":"Dosage form: Extended release tablet Dosage: 2 tablets"},{"intervention_type":"Drug","name":"Drug: DW-0919","description":"Dosage form: Extended release tablet Dosage: 1 tablet"}],"outcomes":[{"outcome_type":"primary","measure":"Cmax of DW-0919(Acetaminophen, Tramadol)","time_frame":"0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36"},{"outcome_type":"primary","measure":"AUC of DW-0920(Acetaminophen, Tramadol)","time_frame":"0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36"},{"outcome_type":"primary","measure":"Cmax of DW-0920(Acetaminophen, Tramadol)","time_frame":"0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36"},{"outcome_type":"primary","measure":"AUC of DW-0919(Acetaminophen, Tramadol)","time_frame":"0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36"}]}
{"nct_id":"NCT01594801","start_date":"2012-05-31","phase":"N/A","enrollment":145,"brief_title":"Testing the Effect of the InsuPad Device in Daily Life Conditions","official_title":"Testing the Effect of the InsuPad Device in Daily Life Conditions - The InsuPad in Daily Life Study","primary_completion_date":"2013-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-03-31","last_update":"2013-03-13","description":"This is the test protocol for the InsuPad device. The aim of the study is to show economical benefit when using the InsuPad device, by testing the effect of the InsuPad device on reducing injected insulin dose while keeping the same overall glycaemic control.","other_id":"CP-PP-003","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female subjects aged 18 to 75 years (including 18 and 75 years old).\r\n\r\n          -  Type 1 or type 2 diabetes mellitus subjects with daily short-acting prandial insulin\r\n             intake of > 60 IU/day.\r\n\r\n          -  HbA1c >=6.0% and =< 8%\r\n\r\n          -  Use of short-acting prandial insulin analogues with multiple daily injections. The\r\n             analog insulin brands to be used will be either insulin Lispro (Humalog, Liprolog) or\r\n             insulin Aspart (NovoRapid) or insulin Glulisin (Apidra).\r\n\r\n          -  Subject agrees to sign consent form before any study-specific tests or procedures are\r\n             to be performed.\r\n\r\n          -  Study subject is willing to perform at least 5 blood glucose measurements per day for\r\n             at least 3 months, willing to comply with study procedures and to keep a detailed\r\n             patient log book.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Excessive fibrosis, lipo-hypertrophy or eczema at injection sites.\r\n\r\n          -  Known gastro- or enteroparesis.\r\n\r\n          -  Unstable chronic disease other than diabetes mellitus (e. g. unstable angina pectoris,\r\n             renal disease) for the last six months before study start.\r\n\r\n          -  Severe hypoglycaemic events requiring glucagon injection or glucose infusion within\r\n             the last four weeks prior to study start.\r\n\r\n          -  Hypoglycaemia unawareness (Score > 4 in the Hypoglycaemia Awareness Questionnaire)\r\n\r\n          -  Diabetic ketoacidosis (severe, with hospitalization) within the last six months prior\r\n             to study start\r\n\r\n          -  Any known life-threatening disease\r\n\r\n          -  Pregnant women, lactating women or women who intend to become pregnant during the\r\n             observation period\r\n\r\n          -  Any other condition or compliance issues that might interfere with study participation\r\n             or results\r\n\r\n          -  Subjects with heat sensitivity\r\n\r\n          -  Subjects involved in or planned to participate in other studies\r\n\r\n          -  Subjects who are incapable of contracting or under guardianship\r\n      ","sponsor":"Insuline Medical Ltd.","sponsor_type":"Industry","conditions":"Diabetics Mellitus Type 1|Diabetes Mellitus Type 2","interventions":[{"intervention_type":"Device","name":"Device: InsuPad","description":"Use of the InsuPad for at least 3 times a day."}],"outcomes":[{"outcome_type":"primary","measure":"Efficacy","time_frame":"3 months","description":"The primary endpoint of the study is to demonstrate the non-inferiority (margin of 0.4%) for overall glycaemic control defined as HbA1c of a treatment regimen applying InsuPad combined with an insulin dose reduction of >10% in the test group compared to the control group not using InsuPad."},{"outcome_type":"primary","measure":"Safety","time_frame":"3 months","description":"compare the Frequency of mild hypoglycaemia events (Blood Glucose < 63 mg/dl or 3. 5 mmol/l) with InsuPad and without InsuPad."}]}
{"nct_id":"NCT01566721","start_date":"2012-05-17","phase":"Phase 3","enrollment":2577,"brief_title":"A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer","official_title":"A Phase III Prospective, Two-Cohort Non-Randomized, Multi-Centre, Multinational, Open-Label Study to Assess the Safety of Assisted- and Self-Administered Subcutaneous Trastuzumab as Therapy in Patients With Operable HER2-Positive Early Breast Cancer","primary_completion_date":"2015-03-10","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-02-19","last_update":"2021-04-27","description":"This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted and self-administered SC Herceptin as adjuvant therapy in participants with early HER2-positive breast cancer following tumor excision. Participants will receive Herceptin 600 milligrams (mg) SC every 3 weeks for 18 cycles, either by an assisted administration using a conventional syringe and needle/vial formulation (Cohort A) or with assisted and self-administration using a single-use injection device (SID) in selected participants (Cohort B).","other_id":"MO28048","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically confirmed early invasive HER2-positive carcinoma of the breast with no\r\n             evidence of residual, locally recurrent, or metastatic disease and defined as clinical\r\n             Stage I to IIIC that is eligible for treatment with Herceptin\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\r\n\r\n          -  Screening left ventricular ejection fraction (LVEF) greater than or equal to () 55%\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Previous neoadjuvant or adjuvant breast cancer treatment with an approved or\r\n             investigational anti-HER2 agent\r\n\r\n          -  History of other malignancy except for curatively treated carcinoma in situ of the\r\n             cervix, basal cell carcinoma, or curatively treated malignancies (other than breast\r\n             cancer) where the participant has been disease-free for at least 5 years\r\n\r\n          -  Past history of ductal carcinoma in situ treated with any systemic therapy or with\r\n             radiation therapy to the ipsilateral breast where invasive cancer subsequently\r\n             developed\r\n\r\n          -  Metastatic disease\r\n\r\n          -  Inadequate bone marrow, hepatic, or renal function\r\n\r\n          -  Serious cardiac or cardiovascular disease including uncontrolled hypertension or\r\n             history of hypertensive crisis or hypertensive encephalopathy\r\n\r\n          -  History of severe allergic or immunological reactions, such as difficult-to-control\r\n             asthma\r\n\r\n          -  Pregnant or lactating women\r\n      ","sponsor":"Hoffmann-La Roche","sponsor_type":"Industry","conditions":"Breast Neoplasms","interventions":[{"intervention_type":"Drug","name":"Drug: Herceptin","description":"Herceptin will be given as 600 mg SC (into thigh) on Day 1 of each 3-week cycle for up to 18 cycles."}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period","time_frame":"From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)","description":"Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. The percentage of participants with at least 1 AE during the treatment period (regardless of severity or seriousness) was reported."},{"outcome_type":"primary","measure":"Percentage of Participants With a Grade 3 or Higher AE During the Treatment Period","time_frame":"From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)","description":"Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. AEs were graded according to National Cancer Institute Common Terminology Criteria Version 4.0. Grade 3 AEs were those considered severe or medically significant but not immediately life-threatening. Grade 4 AEs were those considered life-threatening and/or for which urgent intervention was indicated. Grade 5 AEs were those resulting in death. The percentage of participants with a Grade 3 or higher (i.e., Grade 3 to 5) AE during the treatment period was reported."},{"outcome_type":"primary","measure":"Percentage of Participants With Treatment Interruption Due to an AE","time_frame":"From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)","description":"Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. The percentage of participants with SC Herceptin treatment interrupted to assess or treat AEs was reported."},{"outcome_type":"primary","measure":"Number of Herceptin Cycles Received","time_frame":"From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)","description":"Participants were planned to receive a total of 18 cycles of SC Herceptin. The median number of cycles actually received was reported."},{"outcome_type":"primary","measure":"Percentage of Participants by Total Number of Herceptin Cycles Received","time_frame":"From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)","description":"Participants were planned to receive a total of 18 cycles of SC Herceptin. The percentage of participants was reported by the total number of cycles actually received. Because the data are presented non-cumulatively, this table reflects participant distribution by the highest number of cycles received."},{"outcome_type":"primary","measure":"Percentage of Participants Who Received Concomitant Cancer Therapy","time_frame":"From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years)","description":"Concomitant cancer treatment included chemotherapy, radiotherapy, and hormone therapy administered during the study. The percentage of participants who received any of these concomitant therapies was reported."},{"outcome_type":"primary","measure":"Percentage of Participants Who Received Concomitant Non-Cancer Therapy","time_frame":"From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years)","description":"Concomitant non-cancer treatment included any pharmacologic interventions administered during the study other than chemotherapy, radiotherapy, or hormone therapy. The percentage of participants who received any concomitant non-cancer therapies was reported."},{"outcome_type":"secondary","measure":"Percentage of Participants Who Died by Data Cutoff of 10 March 2015","time_frame":"From Baseline to time of event (maximum follow-up approximately 3 years as of data cutoff of 10 March 2015)","description":"The percentage of participants who died from any cause was reported."},{"outcome_type":"secondary","measure":"Percentage of Participants Who Died During the Safety Follow-up Period","time_frame":"From Baseline to Time of Event, Safety Follow-Up Period (Up to 6 Years)","description":"The percentage of participants who died from any cause was reported during the safety follow-up period."},{"outcome_type":"secondary","measure":"Disease-Free Survival Rate","time_frame":"From Baseline to time of event (up to approximately 8 years)","description":"DFS is defined as the time from first dose of SC Herceptin to the first event of local, regional or distant recurrence, contralateral invasive breast cancer (including ipsilateral ductal carcinoma in situ) or death due to any cause.\r\nTime from the date of first dose to any DFS event was expressed in Kaplan-Meier survival probability estimates. Patients without an event will be censored at the last assessment date."},{"outcome_type":"secondary","measure":"Overall Survival Rate","time_frame":"From Baseline to Time of Event (Up to Approximately 6 Years)","description":"Overall survival was defined as the time from randomization to death from any cause.\r\nTime from the date of randomization to the date of death was expressed in Kaplan-Meier survival probability estimates. Patients without an event will be censored at the last assessment date."},{"outcome_type":"secondary","measure":"Percentage of Participants by Item Response to SID Satisfaction Questionnaire","time_frame":"Cycle 4 (cycle length 3 weeks) and last safety follow-up (LSFU) (approximately 1 year)","description":"The SID satisfaction questionnaire was administered twice during the study and asked participants to respond to five statements using a Likert scale from \"Strongly Disagree\" to \"Strongly Agree\". Questionnaire items were as follows: \"I felt comfortable injecting the study drug by myself\" (Comfortable), \"The SID was convenient and easy to use\" (Easy to Use), \"I am confident giving myself an injection in the thigh with the SID\" (Confident), \"Taking all things into account I find self-administration using the SID satisfactory\" (Satisfactory), \"If given the opportunity I would choose to continue self-injecting the study drug using the SID in the future\" (Continue). Participants could only select one response per questionnaire item. There was no calculation of any score, but rather, descriptive summaries were generated by item response. The percentage of participants was reported by the response given for each item on the SID satisfaction questionnaire."}]}
{"nct_id":"NCT01598311","start_date":"2012-05-16","phase":"Phase 3","enrollment":608,"brief_title":"A Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-006)","official_title":"A Randomized, Double-Blinded, Active-Controlled Study of CB-183,315 in Patients With Clostridium Difficile Associated Diarrhea","primary_completion_date":"2015-07-26","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-08-25","last_update":"2019-07-23","description":"A total of 608 participants with Clostridium Difficile Associated Diarrhea (CDAD) will participate in this study; participants will receive either oral vancomycin or CB-183,315 in a blinded fashion. Treatment will last for 10 days and participants will be followed up for at least 40 days and a maximum of 100 days. The purpose of this study is to evaluate how well CB-183,315 treats CDAD as compared to vancomycin.","other_id":"4261-006","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":89,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Is able to read and sign a consent form;\r\n\r\n          -  Is from 18 to <90 years of age;\r\n\r\n          -  Has diarrhea, at least 3 times during one day, or 200 mL or liquid stool if using a\r\n             rectal device;\r\n\r\n          -  Tests positive for Clostridium difficile;\r\n\r\n          -  If female, must not be pregnant or nursing and take appropriate measures to not get\r\n             pregnant during the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Has toxic megacolon and/or known small bowel ileus;\r\n\r\n          -  Has received treatment with intravenous immune globulin (IVIG) within the past 30\r\n             days;\r\n\r\n          -  Has received treatment with a fecal transplant within 7 days, and/or if the doctor\r\n             anticipates to give the participant a fecal transplant during the study;\r\n\r\n          -  Has received a certain amount of antibacterial therapy specific for current CDAD,\r\n             unless it is not working;\r\n\r\n          -  Has received an investigational vaccine against Clostridium difficile;\r\n\r\n          -  Has received an investigational product containing monoclonal antibodies against toxin\r\n             A or B within 180 days;\r\n\r\n          -  Has more than 2 episodes of CDAD within 90 days;\r\n\r\n          -  Has had major gastrointestinal (GI) surgery (i.e. significant bowel resection) within\r\n             3 months (this does not include appendectomy or cholecystectomy);\r\n\r\n          -  Has a history of prior inflammatory bowel disease: ulcerative colitis, Crohn's\r\n             disease, or microscopic colitis;\r\n\r\n          -  Is unable to discontinue loperamide, diphenoxylate/atropine, or cholestyramine during\r\n             the duration of the study;\r\n\r\n          -  Is unable to discontinue opiate treatment unless on a stable dose;\r\n\r\n          -  Has known positive stool cultures for other enteropathogens including but not limited\r\n             to Salmonella, Shigella, and Campylobacter;\r\n\r\n          -  Has had stool studies positive for pathogenic ova and/or parasites;\r\n\r\n          -  Has an intolerance or hypersensitivity to daptomycin and/or vancomycin;\r\n\r\n          -  Has a life-threatening illness at the time of enrollment;\r\n\r\n          -  Has poor concurrent medical risks that in the opinion of the Investigator the\r\n             participant should not enroll;\r\n\r\n          -  Has received an investigational drug or participated in any experimental procedure\r\n             within 1 month;\r\n\r\n          -  Has human immunodeficiency virus (HIV), a cluster of differentiation (CD) 4 count <200\r\n             cells/mm^3 within 6 months of start of study therapy;\r\n\r\n          -  Anticipates that certain antibacterial therapy for a non-CDAD infection will be\r\n             required for >7 days;\r\n\r\n          -  Is unable to discontinue Saccharomyces or similar probiotic;\r\n\r\n          -  Is on a concurrent intensive induction chemotherapy, radiotherapy, or biologic\r\n             treatment for active malignancy;\r\n\r\n          -  Is unable to comply with the protocol requirements;\r\n\r\n          -  Has any condition that, in the opinion of the Investigator, might interfere;\r\n\r\n          -  Is not expected to live for less than 8 weeks.\r\n      ","sponsor":"Cubist Pharmaceuticals LLC","sponsor_type":"Industry","conditions":"Clostridium Difficile Infection","interventions":[{"intervention_type":"Drug","name":"Drug: CB-183,315","description":"CB-183,315 250 mg white coated tablet over-encapsulated in a size 00 opaque hard gelatin capsule."},{"intervention_type":"Drug","name":"Drug: Vancomycin","description":"Vancomycin hydrochloride 125 mg capsule over-encapsulated in size 00 opaque hard gelatin capsule."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo size 00 opaque hard gelatin capsules."}],"outcomes":[{"outcome_type":"primary","measure":"Adjusted Percentage of Participants Meeting Clinical Response Criteria for Cure at End of Treatment (EOT)","time_frame":"Up to 3 days after EOT (up to Day 13)","description":"The percentage of participants considered \"cured\" (i.e., ≤2 loose stools per 24 hour period for at least 2 consecutive days and no need for additional antibiotics during the 3 days following EOT) was determined in the mMITT population. A CDAD diagnosis was defined as: 1) diarrhea with a minimum of 3 unformed bowel movements (UBM) or >200 mL volume of stool for participants with a collection device (e.g., rectal tube or colostomy bag) over 24 hours; and 2) a positive result for Clostridium difficile toxin by enzyme immunoassay (EIA), polymerase chain reaction (PCR), or a cell culture cytotoxin neutralization assay. Percentages were first stratified according to age (<75 or ≥75 years) and number of previous CDAD episodes (0 or ≥1) and constructed using Mehrotra-Railkar continuity-corrected minimum-risk stratum weights, and the weighted averages were then derived across strata in order to calculate the adjusted percentage."},{"outcome_type":"primary","measure":"Percentage of Participants Experiencing an Adverse Event (AE)","time_frame":"Up to 30 days after EOT (up to Day 40)","description":"An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment."},{"outcome_type":"primary","measure":"Percentage of Participants Discontinuing From Study Treatment Due to an AE","time_frame":"Up to EOT (up to Day 10)","description":"An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment."},{"outcome_type":"secondary","measure":"Number of Clinical Failure Events up to Day 40","time_frame":"Up to 30 days after EOT (up to Day 40)","description":"The total number of clinical failure events, which included treatment failure, CDAD recurrence, death, or being lost to follow-up, occurring during each time period was determined in each arm."},{"outcome_type":"secondary","measure":"Adjusted Percentage of Participants With Sustained Clinical Response at End of Study","time_frame":"Up to 40 days after EOT (up to Day 50)","description":"The percentage of participants with sustained clinical response was determined for each arm. Sustained clinical response was declared when participants had a clinical outcome of cure at EOT, did not experience any CDAD recurrence, did not die, were not lost to follow-up, and did not have the end of study visit prior to Day 40. Percentages were first stratified according to age (<75 or ≥75 years) and number of previous CDAD episodes (0 or ≥1) and constructed using Mehrotra-Railkar continuity-corrected minimum-risk stratum weights, and the weighted averages were then derived across strata in order to calculate the adjusted percentage."}]}
{"nct_id":"NCT04139473","start_date":"2012-05-15","phase":"N/A","enrollment":200,"brief_title":"Randomized Trial of Hepaticojejunostomy Versus Duct-to-duct Anastomosis in Right Lobe Living Donor Liver Transplantation","official_title":"Randomized Trial of Hepaticojejunostomy Versus Duct-to-duct Anastomosis in Right Lobe Living Donor Liver Transplantation","primary_completion_date":"2022-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-12-31","last_update":"2019-10-25","description":"The scarcity of deceased donor organ supply has driven the practice of living donor liver transplantation (LDLT). Right lobe LDLT (RLDLT) has developed over the last 10 years to extend the benefit of LDLT to adult patients. With technical refinement, the results have significantly improved but bile duct complications remain the Achilles heel that affects the recipient's long-term outcome.Hepaticojejunostomy (HJ) was originally the standard technique for bile duct reconstruction in RLDLT but in recent years, duct-to-duct anastomosis (DDA) has been adopted by most transplant centers. The advantages of duct-to-duct reconstruction include a shorter operation time, less infection complications, more physiologic enteric functions and easier endoscopic access to the biliary tract but bile duct complication, particularly stricture is the major concern. The development of stricture is likely to be related to the blood supply of the anastomosis. We hypothesize that HJ has a better blood supply and is associated with a lower overall bile duct complication rate than duct-to-duct anastomosis. We propose a randomized trial to test this hypothesis and to compare various outcome measures between HJ and duct-to-duct reconstruction. The results of the study will set the standard for the technique of biliary reconstruction in RLDLT and will further advance this procedure.","other_id":"UW 12-070","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  recipient age older than 18 years\r\n\r\n          -  primary transplant\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  recipient refusal/withdrawal\r\n\r\n          -  haemodynamic instability at the time of biliary reconstruction\r\n\r\n          -  biliary reconstruction with duct-to-duct anastomosis is unsafe or technically not\r\n             feasible\r\n\r\n          -  unhealthy recipient's bile duct, anatomical variant in donor's right duct\r\n\r\n          -  biliary reconstruction with hepaticojejunostomy is unsafe or technically not feasible\r\n\r\n          -  excessively edematous bowel, failure to create Roux-en-Y jejunal loop due to excessive\r\n\r\n          -  bowel adhesions\r\n      ","sponsor":"The University of Hong Kong","sponsor_type":"Other","conditions":"Liver Failure","interventions":[{"intervention_type":"Procedure","name":"Procedure: Hepaticojejunostomy / Duct-to-duct anastomosis"}],"outcomes":[{"outcome_type":"primary","measure":"Biliary complications","time_frame":"5 years","description":"Compare all biliary-associated complications after operation including leakage and stricture"},{"outcome_type":"secondary","measure":"Operative time for liver transplantation","time_frame":"intraoperative","description":"Duration of operative time"},{"outcome_type":"secondary","measure":"Gastrointestinal function after liver transplantation","time_frame":"5 years","description":"Return of gastrointestinal function"},{"outcome_type":"secondary","measure":"Hospital stay after liver transplantation","time_frame":"5 years","description":"Duration of hospital stay"},{"outcome_type":"secondary","measure":"Chances of re-intervention","time_frame":"5 years","description":"Re-intervention rate"}]}
{"nct_id":"NCT01706978","start_date":"2012-04-30","phase":"N/A","enrollment":176,"brief_title":"A Comparison of Two Adjunctive Treatments in Arthroscopic Cuff Repair","official_title":"A Comparison of Two Adjunctive Treatments in Arthroscopic Cuff Repair: Soft Tissue or Bone Trephination, a Prospective Cohort Study","primary_completion_date":"2018-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-09-30","last_update":"2020-09-18","description":"This Clinical Trial is being conducted to study two adjunctive treatments for rotator cuff repair; soft tissue and bone trephination. \"Trephination\" is a procedure that involves making small perforations either in the torn tendon near its edge, or in the bone that the tendon is repaired to. The rotator cuff is repaired by sewing the tendon down to the bone in the shoulder. Trephination is a new technique that is used in addition to the standard method of repairing the rotator cuff tendon. This study will help to determine whether this technique improves the speed of healing, the strength and the re-tear rate of the repair. You are being asked to take part in this study because you have a tear of the rotator cuff that requires surgical treatment. A total of 90 participants will participate in this study.","other_id":"2009042-01H","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":90,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients who have failed standard non-surgical management of their rotator cuff tear,\r\n             and who would benefit from a surgical repair of the cuff.\r\n\r\n          -  Failed medical management will be defined as persistent pain and disability despite\r\n             adequate standard non-operative management for 6 months.\r\n\r\n        Medical management will be defined as:\r\n\r\n          -  The use of drugs including analgesics and non-steroidal anti-inflammatory drugs\r\n\r\n          -  Physiotherapy consisting of stretching, strengthening and local modalities\r\n             (ultrasound, cryotherapy, etc)\r\n\r\n          -  Activity modification\r\n\r\n          -  Imaging, and intra-operative findings confirming a full thickness tear of the rotator\r\n             cuff.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Characteristics of the cuff tear that render the cuff irrepairable: fatty infiltration\r\n             in the muscles grade III (50%) or greater; superior subluxation of the humeral head;\r\n             retraction of the cuff to the level of the glenoid rim.\r\n\r\n          2. Partial thickness cuff tears.\r\n\r\n          3. Significant shoulder comorbidities e.g. Bankart lesion, osteoarthritis\r\n\r\n          4. Previous surgery on affected shoulder e.g. Previous rotator cuff repair.\r\n\r\n          5. Patients with active worker's compensation claims\r\n\r\n          6. Active joint or systemic infection\r\n\r\n          7. Significant muscle paralysis\r\n\r\n          8. Rotator cuff tear arthropathy\r\n\r\n          9. Charcot's arthropathy\r\n\r\n         10. Significant medical comorbidity that could alter the effectiveness of the surgical\r\n             intervention (eg. Cervical radiculopathy, polymyalgia rheumatica)\r\n\r\n         11. Major medical illness (life expectancy less then 1 year or unacceptably high operative\r\n             risk)\r\n\r\n         12. Unable to speak or read English/French\r\n\r\n         13. Psychiatric illness that precludes informed consent\r\n\r\n         14. Unwilling to be followed for 1 year\r\n\r\n         15. Advanced physiologic age\r\n      ","sponsor":"Ottawa Hospital Research Institute","sponsor_type":"Other","conditions":"Rotator Cuff Tear","interventions":[{"intervention_type":"Procedure","name":"Procedure: Bone Trephination"},{"intervention_type":"Procedure","name":"Procedure: Soft Tissue Trephination"}],"outcomes":[{"outcome_type":"primary","measure":"Western Ontario Rotator Cuff Index","time_frame":"From baseline to up until 24-Months Post-Operative","description":"The Western Ontario Rotator Cuff Index (WORC) is a disease specific evaluation, proven to be an accurate and valid assessment of function after shoulder replacement. The WORC is a patient-reported measure, 19-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean better outcome. These scores are combined and translated into a percentage out of 100. A higher total score indicates a better outcome."},{"outcome_type":"secondary","measure":"American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) Scores","time_frame":"From baseline to up until 24-Months Post-Operative","description":"The ASES is a shoulder specific assessment divided into two sections: pain and activities of daily living (ADL). Pain is recorded on a visual analogue scale (0-10), lower scores indicate better outcomes. There are 10 activities of daily living questions, each are recorded on a 4 level likert scale (0-3), which a higher score indicates a better outcome. The overall score is an equal weight of the two sections and produces a score out of 100. The higher the score, the better the outcome."},{"outcome_type":"secondary","measure":"The Constant Score","time_frame":"From baseline to up until 24-Months Post-Operative","description":"The Constant Score reflects an overall clinical functional assessment. This instrument is based on a 100-point scoring system. Subjective findings (pain, activities of daily living, and working in different positions) make up a total of 35 points. Objective measurements make up the remaining 65 points.The test is divided into four sub-categories: (1) pain is measured using 4 likert levels (15 points maximum), where a higher score indicates a better outcome; activities of daily living are measured using a likert scale, where a higher number indicates better outcomes (20 points maximum); mobility is measured by an assessor, and rated using a likert scale where a higher score indicates better outcomes (40 points maximum); finally, strength is measured by an assessor where 1 point is given per 0.5kg of force (maximum 25 points), a higher score indicates better outcomes. All categories are added together, and a total score out of 100 is given (higher score indicates better outcome)."},{"outcome_type":"secondary","measure":"Healing Rates","time_frame":"From surgery to up until 24-Months Post-Operative","description":"Imaging parameters will be examined using ultrasound and magnetic resonance imaging (MRI). These images will be analyzed to determine healing status of the tissues post-operatively. Imaging will determine whether the tissue is healed, partially torn, or fully torn after surgery. Higher incidence of tearing will be compared between groups. A higher incidence of tearing indicates worse outcomes."}]}
{"nct_id":"NCT01570751","start_date":"2012-04-30","phase":"Phase 3","enrollment":145,"brief_title":"A Trial Comparing the Efficacy, Patient-reported Outcomes and Safety of Insulin Degludec 200 U/mL vs Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Requiring High-dose Insulin","official_title":"A Trial Comparing the Efficacy, Patient-reported Outcomes and Safety of Insulin Degludec 200 U/mL vs Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Requiring High-dose Insulin","primary_completion_date":"2014-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-01-31","last_update":"2017-03-07","description":"This trial is conducted in the United States of America (USA). The aim of the trial is to confirm the efficacy of IDeg (insulin degludec) versus IGlar (insulin glargine) in controlling glycaemia. Subjects are to continue their pre-trial metformin treatment.","other_id":"NN1250-3943","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Type 2 diabetes\r\n\r\n          -  Current treatment with once daily insulin glargine in vials with a daily dose equal to\r\n             or above 65 U and equal to or below 100 U\r\n\r\n          -  Current treatment with a stable dose of metformin plus/minus one additional oral\r\n             antidiabetic drug (OAD) for at least 12 weeks\r\n\r\n          -  Glycosylated haemoglobin (HbA1c) equal to or above 7.5%\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Current treatment with insulin other than insulin glargine in vials\r\n\r\n          -  Treatment with thiazolidinediones or glucagon-like peptide-1 (GLP-1) receptor agonists\r\n             within 12 weeks\r\n\r\n          -  Stroke; heart failure; myocardial infarction; unstable angina pectoris; coronary\r\n             arterial bypass graft or angioplasty\r\n\r\n          -  Suffer from cancer (except basal cell skin cancer and squamous-cell cancer)\r\n      ","sponsor":"Novo Nordisk A/S","sponsor_type":"Industry","conditions":"Diabetes|Diabetes Mellitus, Type 2","interventions":[{"intervention_type":"Drug","name":"Drug: insulin degludec","description":"Cross-over trial, part 1: Individually adjusted IDeg administered subcutaneously (s.c., under the skin) once daily for 16 weeks in each treatment period."},{"intervention_type":"Drug","name":"Drug: insulin glargine","description":"Cross-over trial, part 2: Individually adjusted IGlar administered subcutaneously (s.c., under the skin) once daily for the 16 week run-in period followed by 16 weeks in each treatment period."}],"outcomes":[{"outcome_type":"primary","measure":"Change From Baseline (Visit 18) in Glycosylated Haemoglobin (HbA1c) at the End of Each 16 Week Treatment Period","time_frame":"Week 0, week 16 of each treatment period.","description":"Values for change in HbA1c after each 16 weeks of treatment periods A and B."},{"outcome_type":"secondary","measure":"Change in Patient Reported Outcome (PRO) Scores From Baseline to the End of Each 16 Week Treatment Period","time_frame":"Week 0, week 16 of each treatment period.","description":"Changes in subjects quality of life and insulin device satisfaction were evaluated using the following PROs: the Short-Form 36 Health Survey version 2 (SF-36) and the Treatment Related Impact Measure-Diabetes Device (TRIM-DD). PRO total scores were measured from baseline to the end of each 16-week treatment period. Responses were measured on a scale of 0 to 100, where higher scores indicated a better quality of life and higher insulin device satisfaction on the SF-36 and TRIM-DD questionnaires, respectively."},{"outcome_type":"secondary","measure":"Change in PRO Scores From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B","time_frame":"Week 16, week 20","description":"SF-36 and TRIM-DD total scores were measured at the end of treatment A (week 16) and 4 weeks into treatment B (week 20). Responses were measured on a scale of 0 to 100, where higher scores indicated a better quality of life and higher insulin device satisfaction on the SF-36 and TRIM-DD questionnaires, respectively."},{"outcome_type":"secondary","measure":"Change From Baseline in Central Laboratory Measured Fasting Plasma Glucose (FPG) at the End of Each 16 Week Treatment Period","time_frame":"Week 0, week 16, week 32","description":"Values of FPG in mmol/L from baseline to each 16 weeks of treatment periods."},{"outcome_type":"secondary","measure":"Change in FPG From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B","time_frame":"Week 16, week 20","description":"Values of FPG in mmol/L from the end of treatment period A until after 4 weeks of treatment in treatment period B."},{"outcome_type":"secondary","measure":"Number of Adverse Events (AEs)","time_frame":"From baseline to the end of each 16 week treatment period.","description":"Number of treatment emergent adverse events (TEAEs) from week 0 to week 16 of the randomised treatment periods. A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. TEAEs were attributed to the treatment given in the period in which the event occurred."}]}
{"nct_id":"NCT01584830","start_date":"2012-04-30","phase":"Phase 3","enrollment":204,"brief_title":"Asian Subjects With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy","official_title":"A Randomized, Double-blind, Placebo-controlled Phase III Study of Regorafenib Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Asian Subjects With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy","primary_completion_date":"2013-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-01-31","last_update":"2016-02-08","description":"The purpose of this study is to assess if Regorafenib in combination with best supportive care will slow down tumor progression and result in increased survival in patients with metastatic colorectal cancer.","other_id":"15808","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histological or cytological documentation of adenocarcinoma of the colon or rectum.\r\n             All other histological types are excluded.\r\n\r\n          -  Subjects with metastatic colorectal cancer(CRC) (Stage IV).\r\n\r\n          -  Subjects must have failed at least two lines of prior treatment.\r\n\r\n          -  Progression during or within 3 months following the last administration of approved\r\n             standard therapies which must include a fluoropyrimidine, oxaliplatin and irinotecan.\r\n\r\n               -  Subjects treated with oxaliplatin in an adjuvant setting should have progressed\r\n                  during or within 6 months of completion of adjuvant therapy.\r\n\r\n               -  Subjects who progress more than 6 months after completion of oxaliplatin\r\n                  containing adjuvant treatment must be retreated with oxaliplatin-based therapy to\r\n                  be eligible.\r\n\r\n               -  Subjects who have withdrawn from standard treatment due to unacceptable toxicity\r\n                  warranting discontinuation of treatment and precluding retreatment with the same\r\n                  agent prior to progression of disease will also be allowed into the study.\r\n\r\n               -  Subjects may have received prior treatment with Avastin (bevacizumab) and/or\r\n                  Erbitux (cetuximab)/Vectibix (panitumumab) (if KRAS WT)\r\n\r\n          -  Metastatic CRC subjects must have measurable or non measurable disease according to\r\n             Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1.\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 1.\r\n\r\n          -  Life expectancy of at least 3 months.\r\n\r\n          -  Adequate bone marrow, liver and renal function as assessed by the laboratory required\r\n             by protocol.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior treatment with Regorafenib.\r\n\r\n          -  Previous or concurrent cancer that is distinct in primary site or histology from\r\n             colorectal cancer within 5 years prior to randomization EXCEPT for curatively treated\r\n             cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta\r\n             (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)].\r\n\r\n          -  Extended field radiotherapy within 4 weeks or limited field radiotherapy within 2\r\n             weeks prior to randomization.\r\n\r\n          -  Cardiological disease including Congestive heart failure, Unstable angina, Myocardial\r\n             infarction, Cardiac arrhythmias requiring anti-arrhythmic therapy.\r\n\r\n          -  Uncontrolled hypertension. (Systolic blood pressure 150 mmHg or diastolic pressure 90\r\n             mmHg despite optimal medical management).\r\n\r\n          -  Subjects with phaeochromocytoma.\r\n\r\n          -  Pleural effusion or ascites that causes respiratory compromise.\r\n\r\n          -  Arterial or venous thrombotic or embolic events.\r\n\r\n          -  Any history of or currently known brain metastases.\r\n\r\n          -  Interstitial lung disease with ongoing signs and symptoms at the time of informed\r\n             consent.\r\n\r\n          -  Systemic anticancer therapy including cytotoxic therapy, signal transduction\r\n             inhibitors, immunotherapy, and hormonal therapy during this trial or within 4 week.\r\n      ","sponsor":"Bayer","sponsor_type":"Industry","conditions":"Colorectal Neoplasms","interventions":[{"intervention_type":"Drug","name":"Drug: Regorafenib (BAY73-4506)","description":"Regorafenib BAY73-4506 will be given 3 weeks on/1 week off (160 mg od po.)"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo will be given 3 weeks on/1 week off (160 mg od po.)"}],"outcomes":[{"outcome_type":"secondary","measure":"Disease Control Rate (DCR)","time_frame":"From randomization of the first subject untill 154 death events observed, up to 2 years","description":"DCR is defined as the percentage of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating)"},{"outcome_type":"primary","measure":"Overall Survival (OS)","time_frame":"From randomization of the first subject untill 154 death events observed, up to 2 years","description":"OS is defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact."},{"outcome_type":"secondary","measure":"Progression-free Survival (PFS)","time_frame":"From randomization of the first subject untill 154 death events observed, up to 2 years","description":"PFS was defined as the time from date of randomization to disease progression radiological/clinical or death due to any cause, whichever occurs first. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation."},{"outcome_type":"secondary","measure":"The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR).","time_frame":"From randomization of the first subject untill 154 death events observed, up to 2 years"},{"outcome_type":"secondary","measure":"Safety variables will be summarized using descriptive statistics based on adverse events collection","time_frame":"From randomization of the first subject untill 154 death events observed, up to 2 years"}]}
{"nct_id":"NCT01722110","start_date":"2012-04-30","phase":"Phase 1","enrollment":32,"brief_title":"Bioequivalence Study of Indomethacin Extended-Release Capsules 75 mg Under Fed Condition","official_title":"A Randomized, Balanced, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of Indomethacin Extended-Release Capsules 75 mg of Ipca Laboratories Ltd., With Indomethacin Extended-Release Capsules USP 75 mg of Epic Pharma, USA, in Normal, Healthy, Adult, Male and Female Human Subjects Under Fed Conditions.","primary_completion_date":"2012-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-06-30","last_update":"2012-11-06","description":"This is a randomized, balanced, open Label, two-treatment, two-period, two-sequence, single dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fed condition in normal, healthy, adult, male and female human subjects.","other_id":"Ipca/ARL-10/436","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Male and non pregnant female human subjects, age in the range of 18 - 45 years.\r\n\r\n          2. Body weight within  15% of ideal weight as related to height and body frame according\r\n             to Life Insurance Corporation (LIC) Chart.\r\n\r\n          3. Subjects with normal findings as determined by baseline history, physical examination\r\n             and vital sign examination (blood pressure, pulse rate, respiration rate and axillary\r\n             temperature).\r\n\r\n          4. Subjects with clinically acceptable findings as determined by haemogram, biochemistry,\r\n             urinalysis and 12 lead ECG.\r\n\r\n          5. Subject's willing to give written informed consent.\r\n\r\n          6. Willingness to follow the protocol requirements especially abstaining from xanthine\r\n             containing food or beverages (chocolates, tea, coffee or cola drinks) or grapefruit\r\n             juice, any alcoholic products, the use of cigarettes and tobacco products for 48 hours\r\n             prior to dosing until after the last blood sample collection in each study period and\r\n             adherence to food, fluid and posture restrictions.\r\n\r\n          7. No history of significant alcoholism.\r\n\r\n          8. No history of drug abuse (benzodiazepines and barbiturates) for the last one month and\r\n             other illegal drugs for the last 6 months.\r\n\r\n          9. Non-smokers were included.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Known history of hypersensitivity to Indomethacin or related drugs.\r\n\r\n          2. Requiring medication for any ailment having enzyme-modifying activity in the previous\r\n             28 days, prior to dosing day.\r\n\r\n          3. Subjects who have taken prescription medications or over-the-counter products\r\n             (including vitamins and minerals) within 14 days prior to administration of\r\n             Investigational Product.\r\n\r\n          4. Any medical or surgical conditions, which might significantly interfere with the\r\n             functioning of gastrointestinal tract, blood-forming organs etc.\r\n\r\n          5. History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological,\r\n             metabolic, haematological, gastrointestinal, endocrine, immunological or psychiatric\r\n             diseases.\r\n\r\n          6. Participation in a clinical drug study or bioequivalence study 90 days prior to\r\n             present study.\r\n\r\n          7. History of malignancy or other serious diseases.\r\n\r\n          8. Blood donation 90 days prior to the commencement of the study.\r\n\r\n          9. Subjects with positive HIV tests, HBsAg or Hepatitis-C tests.\r\n\r\n         10. Found positive in breath alcohol test.\r\n\r\n         11. Found positive in urine test for drug abuse.\r\n\r\n         12. History of problem in swallowing.\r\n\r\n         13. Any contraindication to blood sampling.\r\n\r\n         14. Found positive serum Beta- hCG (Human Chorionic Gonadotropin) test.\r\n\r\n         15. Lactating women (currently breast feeding).\r\n\r\n         16. Female subjects not confirming to using birth control measures, from the date of\r\n             screening until the completion of the study. Abstinence, barrier methods (condom,\r\n             diaphragm, etc.) were acceptable. Use of hormonal contraceptives either oral or\r\n             implants.\r\n\r\n         17. Female subjects whose menstruation cycle coincided with the study periods.\r\n      ","sponsor":"IPCA Laboratories Ltd.","sponsor_type":"Industry","conditions":"Fed","interventions":[{"intervention_type":"Drug","name":"Drug: Indomethacin Extended-Release Capsules USP 75 mg","description":"75 mg tablet once a day"},{"intervention_type":"Drug","name":"Drug: Indomethacin Extended Release Capsules USP 75 mg","description":"75 mg tablet once a day"}],"outcomes":[{"outcome_type":"primary","measure":"Bioequivalence is based on Cmax and AUC parameters.","time_frame":"2 months","description":"Sampling Hours: Pre-dose and at 0.50, 1.00, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 12.00, 16.00, 20.00, 24.00, 36.00 and 48.00 hrs post dose."}]}
{"nct_id":"NCT01920659","start_date":"2012-04-30","phase":"N/A","enrollment":188,"brief_title":"METAPREDICT: Developing Predictors of the Health Benefits of Exercise for Individuals","official_title":"Developing Predictors of the Health Benefits of Exercise for Individuals","primary_completion_date":"2014-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-10-31","last_update":"2014-12-03","description":"Physical activity is a powerful lifestyle factor that on average reduces risk for development of diabetes and cardiovascular disease. Nevertheless, investigators have demonstrated that following supervised endurance exercise training, 20% of subjects show no change in fitness and 30% demonstrate no improvement in insulin sensitivity. Our concept is that by using molecular profiling of blood/muscle samples investigators will develop personalised lifestyle intervention tools. Further, revealing the biological basis for a variable metabolic or cardiovascular response to exercise will enable us to propose new targets and biomarkers for drug discovery efforts directly in humans. Using our established OMICS approaches (RNA, DNA and Metabo-) investigators will generate classifiers that predict the responses to exercise-therapy (fitness and insulin sensitivity). Classifier generation is a statistical strategy for diagnosis or prognosis. Critically, investigators have a large human tissue biobank, including subjects with insulin-resistance; young to elderly males and females, as well as twins. Our SME partner has significant intellectual property and capacity in the field of bio-prediction, with a proven track-record of collaboration with the team and product development. Investigators will add to the diversity of our biobank by carrying-out an exercise intervention study using a novel time-efficient strategy that investigators have recently proven to be effective in reducing insulin resistance in sedentary young people and in middle aged obese subjects. A time-efficient protocol is a critical as lack-of-time is a key reason for not maintaining physical activity levels. Finally, investigators have a novel out-bred rodent model that replicates high and low exercise training responses and investigators will establish its suitability for future drug screening purposes. Because of these substantial pre-existing resources investigators believe that our project has a very high probability of delivering on its goals of improving the healthcare of European citizens.","other_id":"METAPREDICT FP7","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Sedentary behavior\r\n\r\n          -  BMI over 27 (kg/m2) or fasting glucose consistent with WHO criteria for impaired\r\n             glucose tolerance\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Physical active\r\n      ","sponsor":"Loughborough University","sponsor_type":"Other","conditions":"Insulin Sensitivity|Physical Activity","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: REHIT","description":"6 weeks 3 x week (20sec intervals)"},{"intervention_type":"Behavioral","name":"Behavioral: High Intensity Training (HIT)","description":"6 weeks of HIT, 3 times a week (3-5 1min on/off)"}],"outcomes":[{"outcome_type":"primary","measure":"Insulin Sensitivity","time_frame":"2 years","description":"Genomic methods and OGTT"},{"outcome_type":"secondary","measure":"Physical Fitness","time_frame":"2 years","description":"VO2max"}]}
{"nct_id":"NCT01585519","start_date":"2012-04-30","phase":"N/A","enrollment":50,"brief_title":"A Study Examining Effects of Apples/ Apple Products on Heart Disease Risk","official_title":"Effect of Increased Whole Apple Consumption, Apple Extract and Freeze-dried Apple Products on Biomarkers of Cardiovascular Disease Risk: a Randomised Intervention in Participants at Increased Risk of Cardiovascular Disease","primary_completion_date":"2013-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-07-31","last_update":"2017-10-24","description":"This study will examine if health benefits of consuming nutrient-rich apples, an apple extract and freeze dried apple product will be similar. 50 volunteers at increased risk of heart disease will consume either a low apple diet (<1 portion/d), 2 high or low polyphenol apples/day, an apple extract, or freeze dried apple granule product for 4 weeks (ten participants per group, randomly assigned). Apart from the extract group, all volunteers will consume a placebo. All volunteers will follow a low apple diet (<1 apple per day) other than what has been provided by the research team. Volunteers will complete food diaries at the start and end of the study and a number of questionnaires. Blood and urine samples collected at 0 and 4 weeks","other_id":"11.22v5","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  > 50 years old or\r\n\r\n          -  Current Smoker or\r\n\r\n          -  Systolic Blood Pressure 120-139mmHg/ Diastolic Blood Pressure 80-89mmHg or\r\n\r\n          -  Total Cholesterol >5.2mmol/l or HDL cholesterol <1.03mmol/l or\r\n\r\n          -  BMI >25 kg/m2\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Diabetes mellitus\r\n\r\n          -  An acute coronary syndrome or transient ischaemic attack within the past 3 months\r\n\r\n          -  Special dietary requirements, food sensitivities or vegetarian/ vegan diet by choice\r\n\r\n          -  Oral anticoagulation therapy\r\n\r\n          -  BMI >35 kg/m2\r\n\r\n          -  Excessive alcohol consumption (>28 U/week men or >21 U/week women)\r\n\r\n          -  Pregnancy/ lactation\r\n\r\n          -  Taking antioxidant supplements\r\n\r\n          -  Medical conditions or dietary restrictions that would substantially limit ability to\r\n             complete the study requirements\r\n      ","sponsor":"Queen's University, Belfast","sponsor_type":"Other","conditions":"Cardiovascular Disease","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: High/ Low Epicatechin Apples/ Apple Extract/ Granules","description":"(Group 1) Low Apple Diet (i.e. <1 portion per day) + 2 placebo capsules daily.\r\n(Group 2) 2 x High Epicatechin Apples daily + 2 placebo capsules daily.\r\n(Group 3) 2 x Low Epicatechin Apples daily + 2 placebo capsules daily.\r\n(Group 4) Low apple diet + 2 x 4.4g of apple granules daily + 2 placebo capsules daily.\r\n(Group 5) Low apple diet + 2 x Apple Extract Capsules daily."}],"outcomes":[{"outcome_type":"primary","measure":"Between group change in oxidised-LDL","time_frame":"Weeks 0 and 4"},{"outcome_type":"secondary","measure":"Between group change in self-reported apple or apple product intake","time_frame":"Weeks 0 and 4"},{"outcome_type":"secondary","measure":"Between group change in biochemical markers of nutritional status","time_frame":"Weeks 0 and 4","description":"Polyphenol levels (including epicatechin and quercetin) in plasma. Vitamin C and carotenoid concentrations in serum. Polyphenol and carotenoid concentrations in LDL."},{"outcome_type":"secondary","measure":"Between group change in biomarkers of cardiovascular disease risk","time_frame":"Weeks 0 and 4","description":"Blood pressure will be measured twice from the right arm, using an automated Omron sphygmomanometer, with the participant sitting quietly for at least five minutes.\r\nTotal cholesterol, HDL cholesterol and triglycerides in serum will be measured using automated enzymatic assays.\r\nHigh sensitivity CRP will be assessed by automated immunoassay.\r\nWeight will be monitored weekly over the 4 week intervention."},{"outcome_type":"secondary","measure":"Between group change in other biomarkers of cardiovascular disease risk","time_frame":"Weeks 0 and 4","description":"Isoprostanes in urine by ELISA. Serum ICAM-1, VCAM-1 and E-selectin, LDL particle size, malondialdehyde in serum by HPLC."}]}
{"nct_id":"NCT01603745","start_date":"2012-04-30","phase":"Phase 1","enrollment":10,"brief_title":"Effects of Drospirenone-ethinylestradiol and/or NOMAC-valerate Estradiol on Cardiovascular Risk in Women With Polycystic Ovary Syndrome","primary_completion_date":"2012-05-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2012-10-31","last_update":"2012-05-22","description":"Polycystic ovary syndrome (PCOS) is often associated with pathological conditions, such as insulin resistance (IR), type 2 diabetes (DM2), obesity and it has potentially increased risk for cardiovascular disease (CVD). Of note, risk factors for CVD including dyslipidaemia, hypertension, oxidative stress and inflammation are associated with PCOS. The investigators want to evaluate the effects of two different types of E/P therapy on cardiovascular risk in PCOS.","other_id":"zoely1984","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":35,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  patients with PCOS aged 18-35 years\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  chronic or acute inflammatory disease\r\n\r\n          -  cancer\r\n\r\n          -  autoimmune disease\r\n\r\n          -  treatment with clomiphene citrate\r\n\r\n          -  antiandrogens\r\n\r\n          -  drugs to control appetite or insulin-sensitizing drugs (metformin, pioglitazone and\r\n             rosiglitazone) during the last 6 months prior to our evaluation, DM2, hypertension,\r\n             major surgery in the last 3 months or other hormonal dysfunctions (hypothalamic,\r\n             pituitary, thyroidal, or adrenal causes)\r\n      ","sponsor":"Catholic University of the Sacred Heart","sponsor_type":"Other","conditions":"Polycystic Ovary Syndrome","interventions":[{"intervention_type":"Drug","name":"Drug: Zoely","description":"1 pill every day"},{"intervention_type":"Drug","name":"Drug: Yasmin","description":"1 pill every day"}],"outcomes":[{"outcome_type":"primary","measure":"cardiovascular risk","time_frame":"120 minutes","description":"total testosterone (T), SHBG, androstenedione (A), 17-hydroxyprogesterone (17-OHP), dehydroepiandrosterone sulphate (DHEAS), triglycerides, total cholesterol, high- and low-density lipoprotein cholesterol (HDL and LDL cholesterol) and alanine aminotransferase (ALT),CD4+CD28null frequency"}]}
{"nct_id":"NCT02150278","start_date":"2012-04-30","phase":"N/A","enrollment":120,"brief_title":"Effectiveness of an Intervention to Reduce Driving Under the Influence of Alcohol Among Drivers","official_title":"Effectiveness of an Intervention to Reduce Driving Under the Influence of Alcohol Among Drivers","primary_completion_date":"2013-07-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2014-09-30","last_update":"2014-05-29","description":"Objectives: The main objective of this pilot study is to assess the feasibility and effectiveness of a brief intervention to reduce drinking-driving behavior. Methods: Design: Pilot multicentre before/after intervention study without control group. Participants: We aim to recruit, from 01/01/2013 to 01/05/2013, 212 drivers aged 18 to 65 who declared to have consumed alcohol previous to driving, at least once in the past 30 days. Intervention: Brief behavioral intervention to reduce alcohol consumption before driving. Outcomes: Frequency of driving under the influence of alcohol in the past 30 days, regular alcohol consumption (Audit-C test), level of self-efficacy and stage of change according to the Prochaska and DiClemente's Transtheoretical Model of Change, sociodemographic variables, driver's profile, chronic pathologies, long -term medications, level of self risk perception. Information will be checked against medical record. Information on a) frequency of driving under the influence of alcohol in the past 30 days, b) regular alcohol and c) level of self-efficacy and stet of change according Prochaska State will be gathered at one month and 12 month post intervention. Descriptive bivariate analysis to assess the distribution of risk elements associated to drinking-driving behavior. Potential impact expected: This pilot project will determine the feasibility of making a brief advice intervention in drivers under the influence of alcohol in primary care.","other_id":"PREVENCON","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  drivers with driving license of any vehicle with current validity\r\n\r\n          -  People aged 18 to 65 years\r\n\r\n          -  People attended Primary Health Care reported having consumed any alcohol at least one\r\n             time before driving the 30 days prior\r\n\r\n        Exclusion criteria:\r\n\r\n          -  People advise against that approach: severe psychiatric illnesses and terminals\r\n\r\n          -  Patients with a diagnosis of alcohol dependence\r\n\r\n          -  Difficulty communication language\r\n\r\n          -  Unstable demographic status: People residing outside the study area, traffic situation\r\n      ","sponsor":"Jordi Gol i Gurina Foundation","sponsor_type":"Other","conditions":"Alcohol Consumption|Traffic Accident|Risk Perception of Driving After Alcohol Consumption","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Brief intervention","description":"The brief intervention consist of one face to face minimal advice to reduce drinking-driving behavior and it was personalized according to the state of change of the patient (based on the Prochaska and DiClemente model). An additional informative pamphlet is offered to the participant. The intervention was done by the general practitioner or nurse that regularly attends the patient."}],"outcomes":[{"outcome_type":"primary","measure":"Frequency of driving under the influence of alcohol in the past 30 days","time_frame":"up to month 12 post-intervention","description":"We will gather a) the number of times that the patient drinks any amount of alcohol previous to driving and b) the amount alcohol consumed previous to driving"},{"outcome_type":"secondary","measure":"Stage of change","time_frame":"Information will be gathered at baseline, at month 1 post-intervention, and at month 12 post-intervention.","description":": Stage of change according to the Prochaska and DiClemente's Transtheoretical Model of Change, also called The Transtheoretical Model (TTM) wich assumes that individuals change habitual behaviors through a cyclical process. It includes the following stages: precontemplation, contemplation, preparation and action, among others"},{"outcome_type":"secondary","measure":"Regular alcohol consumption","time_frame":"Information will be gathered at baseline, at month 1 post-intervention, and at month 12 post-intervention.","description":"Regular alcohol consumption according to the Audit-C test in units of standard drinks weekly consumed (UBE). Information will be checked against patient's medical record."}]}
{"nct_id":"NCT01625260","start_date":"2012-04-30","phase":"Phase 1/Phase 2","enrollment":52,"brief_title":"A Study of ALT-801 in Patients With Bacillus Calmette-Guerin (BCG) Failure Non-Muscle Invasive Bladder Cancer","official_title":"A Phase Ib/II Study of ALT-801 in Patients With Bacillus Calmette-Guerin (BCG) Failure Non-muscle Invasive Bladder Cancer","primary_completion_date":"2015-04-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2018-03-31","last_update":"2017-01-24","description":"This is a Phase Ib/II, open-label, multi-center and competitive enrollment study of ALT-801 combined with gemcitabine for patients who have BCG failure (defined as refractory, relapsing or intolerant), non-muscle invasive bladder cancer and refuse or are not medically fit to undergo a radical cystectomy recommended by the participating urologist as the standard next therapy per urologic guidelines. The purpose of this study is to confirm the safety and tolerability of a well-tolerated dose level of ALT-801, to determine the Recommended Dose level (RD) and characterize the immunogenicity of ALT-801 combined with gemcitabine in treated patients. The anti-tumor responses will also be assessed.","other_id":"CA-ALT-801-01-12","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        ENTRY CRITERIA:\r\n\r\n        DISEASE CHARATERISTICS:\r\n\r\n          -  Histologically confirmed high-risk (high grade Ta, T1 or carcinoma in situ, tumor >4\r\n             cm or multi-focal) transitional cell carcinoma s/p TURBT with no remaining resectable\r\n             disease within 4 weeks of study entry\r\n\r\n          -  Intolerant of treatment with BCG or failure (refractory or relapsing) of at least one\r\n             prior treatment with BCG\r\n\r\n          -  Refuse or intolerant of a radical cystectomy\r\n\r\n          -  No Evidence of regional and/or distant metastasis\r\n\r\n        PRIOR/CONCURRENT THERAPY:\r\n\r\n          -  No concurrent radiotherapy, other chemotherapy, or other immunotherapy\r\n\r\n          -  No scheduled radiotherapy, chemotherapy, other immunotherapy, or surgery before the\r\n             scheduled response evaluation\r\n\r\n          -  Must have recovered from side effects of prior treatments\r\n\r\n          -  No concurrent use of other investigational agents\r\n\r\n        PATIENT CHARACTERISTICS:\r\n\r\n        Age\r\n\r\n          18 years\r\n\r\n        Performance Status\r\n\r\n         ECOG 0, 1, or 2\r\n\r\n        Bone Marrow Reserve\r\n\r\n          -  Absolute neutrophil count (AGC/ANC)  1,000/uL\r\n\r\n          -  Platelets  100,000/uL\r\n\r\n          -  Hemoglobin  8 g/dL\r\n\r\n        Renal Function\r\n\r\n         Glomerular Filtration Rate (GFR)  50mL/min\r\n\r\n        Hepatic Function\r\n\r\n          -  Total bilirubin  2.0 X ULN\r\n\r\n          -  AST, ALT, ALP  3.0 X ULN\r\n\r\n        Cardiovascular\r\n\r\n          -  No congestive heart failure < 6 months\r\n\r\n          -  No severe/unstable angina pectoris < 6 months\r\n\r\n          -  No myocardial infarction < 6 months\r\n\r\n          -  No history of ventricular arrhythmias\r\n\r\n          -  No NYHA Class > II CHF\r\n\r\n          -  No uncontrollable supraventricular arrhythmias\r\n\r\n          -  No history of a ventricular arrhythmia\r\n\r\n          -  No other clinical signs of severe cardiac dysfunction\r\n\r\n          -  Normal Transthoracic Echocardiogram (TTE) is required for patients who have history of\r\n             EKG abnormalities, CHF, coronary artery disease or other cardiac disease, or have\r\n             history of having received adriamycin or doxorubicin\r\n\r\n          -  No patients with a left ventricular ejection fraction (LVEF) of less than 50%\r\n\r\n        Pulmonary\r\n\r\n         Normal clinical assessment of pulmonary function\r\n\r\n        Other\r\n\r\n          -  Negative serum pregnancy test if female and of childbearing potential\r\n\r\n          -  Women who are not pregnant or nursing\r\n\r\n          -  Subjects, both females and males, with reproductive potential must agree to use\r\n             effective contraceptive measures for the duration of the study\r\n\r\n          -  No known autoimmune disease other than corrected hypothyroidism\r\n\r\n          -  No known prior organ allograft or allogeneic transplantation\r\n\r\n          -  Not HIV positive\r\n\r\n          -  No active systemic infection requiring parenteral antibiotic therapy\r\n\r\n          -  No ongoing systemic steroid therapy required\r\n\r\n          -  No history or evidence of uncontrollable CNS disease\r\n\r\n          -  No psychiatric illness/social situation\r\n\r\n          -  No other illness that in the opinion of the investigator would exclude the subject\r\n             from participating in the study\r\n\r\n          -  Must provide informed consent and HIPAA authorization and agree to comply with all\r\n             protocol-specified procedures and follow-up evaluations\r\n      ","sponsor":"Altor BioScience","sponsor_type":"Industry","conditions":"Non-muscle Invasive Bladder Cancer","interventions":[{"intervention_type":"Biological","name":"Biological: ALT-801","description":"Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 3, 5, 8 and 15 of each course."},{"intervention_type":"Drug","name":"Drug: Gemcitabine","description":"Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 1 and 8 of each course."}],"outcomes":[{"outcome_type":"primary","measure":"Safety Profile","time_frame":"12 weeks","description":"For Phase Ib & II\r\nNumber and severity of treatment related AEs that occur or worsen after the first dose of study treatment"},{"outcome_type":"primary","measure":"Tolerability of ALT-801 combined with gemcitabine and designation of the Recommended Dose level (RD)","time_frame":"12 weeks","description":"For phase Ib only\r\nTolerability of a well-tolerated dose level of ALT-801 combined with gemcitabine and designation of the recommended dose level (RD)"},{"outcome_type":"primary","measure":"Clinical Benefit","time_frame":"up to 13 weeks","description":"For Phase Ib & II\r\nNumber of participants with a complete response"},{"outcome_type":"secondary","measure":"Duration of response","time_frame":"up to 3 years","description":"For Phase Ib & II\r\nAll responding patients will be followed every 3 months during years 1 and 2 and every 6 month during year 3 to determine their duration of response"},{"outcome_type":"secondary","measure":"Progression-free survival","time_frame":"up to 3 years","description":"For Phase Ib & II\r\nAll patients receiving one complete dose of ALT-801 will be followed every 3 months during years 1 and 2 and every 6 month during year 3 to determine their progression-free survival"},{"outcome_type":"secondary","measure":"Event free survival","time_frame":"up to 3 years","description":"For Phase Ib & II\r\nAll patients receiving one complete dose of ALT-801 will be followed every 3 months during years 1 and 2 and every 6 month during year 3 to determine their event-free survival"},{"outcome_type":"secondary","measure":"Overall survival","time_frame":"up to 3 years","description":"For Phase Ib & II\r\nAll patients receiving one complete dose of ALT-801 will be followed every 3 months during years 1 and 2 and every 6 month during year 3 to determine their overall survival"},{"outcome_type":"secondary","measure":"Immunogenicity of ALT-801","time_frame":"8 weeks","description":"For Phase Ib & II\r\nMeasures the anti-ALT-801 and IL-2 neutralizing effects"},{"outcome_type":"secondary","measure":"Tumor Typing","time_frame":"1 month","description":"For Phase Ib & II\r\nAssess the relationship between the tumor presentation of HLA-A*0201/p53 aa 264-272 complexes and the safety, immune response and clinical benefit of study treatment"}]}
{"nct_id":"NCT01638429","start_date":"2012-04-30","phase":"Early Phase 1","enrollment":11,"brief_title":"Role of Methane in Glycemic Control","official_title":"Methane Production and Glycemic Regulation in Pre-diabetic Subjects: Role of Methane in Glycemic Control","primary_completion_date":"2014-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-04-30","last_update":"2019-05-02","description":"The purpose of this study is to determine how certain types of bacteria in the human gut may affect weight gain, and contribute to the development of diabetes. The investigators initial studies have shown that gut bacteria that produce methane may directly affect weight gain. These bacteria, called methanogens, produce methane gas as a byproduct, which can be detected through breath testing. Methane can slow the passage of food through the intestines, which would allow extra time for uptake and absorption of nutrients and calories, and might contribute to weight gain. The investigators have also found that people who have increased levels of methane-producing bacteria in their intestines also have higher levels of glucose in their blood. Therefore, control of how the body responds to insulin and uses glucose may be altered in methane-producing individuals. This research study is designed to test the investigational use of the drugs neomycin and rifaximin that have been approved by the U.S Food and Drug Administration (FDA). While neomycin is FDA-approved for treating skin infections, preparing the bowel for surgery, and hepatic encephalopathy (a condition that occurs when a damaged liver cannot remove the toxins that a healthy liver normally would), and rifaximin is FDA-approved for treating travelers' diarrhea, they are not yet approved to be used together for the treatment of methanogens or obesity.","other_id":"25182","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18-65 years old with pre-diabetes (hemoglobin a1c of 5.7-6.4%)\r\n\r\n          -  BMI > 25.0\r\n\r\n          -  presence of methane on a breath sample (>3ppm)\r\n\r\n        Exclusion Criteria:\r\n\r\n        Subjects will be excluded from the study if they exhibit any of the following:\r\n\r\n          -  Diabetes/diabetes medications\r\n\r\n          -  Prokinetic medication\r\n\r\n          -  Pregnancy\r\n\r\n          -  History of bariatric or intestinal surgery (other than cholecystectomy or\r\n             appendectomy)\r\n\r\n          -  Unstable thyroid disease\r\n\r\n          -  An active weight loss treatment/plan\r\n\r\n          -  Smoking\r\n\r\n          -  Dietary restrictions (lactose intolerance, vegan etc)\r\n\r\n          -  Other inability to comply with the study procedures, including known allergy to the\r\n             study antibiotics (neomycin and rifaximin)\r\n\r\n          -  Active inflammatory bowel disease (celiac, Crohn's disease, ulcerative colitis)\r\n\r\n          -  Antibiotic use in the past month\r\n\r\n          -  Subjects who do not have a microwave (for reheating study meals) and a freezer (for\r\n             storing leftovers and stool samples) will be excluded from this study.\r\n\r\n          -  Subjects who have an aspirin sensitivity\r\n\r\n          -  Proton pump inhibitor medications or antacids\r\n\r\n          -  History of bezoar\r\n\r\n          -  Disorders of swallowing\r\n\r\n          -  Suspected strictures, fistulas or physiological GI obstruction\r\n\r\n          -  GI surgery within 3 months\r\n\r\n          -  Severe dysphagia to food or pills\r\n\r\n          -  Diverticulitis\r\n\r\n          -  Subjects who use an implanted or portable electromechanical device such as a cardiac\r\n             pacemaker or infusion pump\r\n\r\n          -  Subject who have a peanut allergy\r\n      ","sponsor":"Cedars-Sinai Medical Center","sponsor_type":"Other","conditions":"Diabetes|Obesity","interventions":[{"intervention_type":"Drug","name":"Drug: Neomycin","description":"Neomycin: 500mg po bid for 10 days"},{"intervention_type":"Drug","name":"Drug: Rifaximin","description":"Rifaximin: 550mg po tid for 10 days"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Subjects Who Eradicated Methane on Breath Test","time_frame":"Baseline and 1-14 days following completion of antibiotic treatment","description":"Number of subjects who exhibited a decrease in breath methane levels to below detectable (below 3ppm) following antibiotic treatment.\r\nAfter baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment breath tests were performed within 2 weeks (14 days) of completing the course of antibiotics."},{"outcome_type":"primary","measure":"Stool Methanogen Levels","time_frame":"Baseline and 1-60 days following completion of antibiotic treatment","description":"Stool methanogen levels were measured in all subjects before and after antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment stool samples were collected within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days.\r\nFor analysis, subjects were grouped into two groups:\r\nGroup 1 - Methane Eradicators (subjects who eradicated methane on breath test following antibiotic treatment) (N=8) Group 2 - Methane Non-eradicators (subjects who did not eradicate methane on breath test following antibiotic treatment) (N=3)"},{"outcome_type":"primary","measure":"Stool Total Bacteria Levels","time_frame":"Baseline and 1-60 days following completion of antibiotic treatment","description":"Stool total bacteria levels were measured in all subjects before and after antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics.Post-treatment stool samples were collected within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups:\r\nGroup 1 - Methane Eradicators (subjects who eradicated methane on breath test following antibiotic treatment) (N=8) Group 2 - Methane Non-eradicators (subjects who did not eradicate methane on breath test following antibiotic treatment) (N=3)"},{"outcome_type":"primary","measure":"Low Density Lipoprotein (LDL) Levels Before and After Antibiotic Therapy","time_frame":"Baseline and 1-60 days following completion of antibiotic treatment","description":"LDL levels were measured in all subjects before and after antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment blood samples were collected within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days.\r\nFor analysis, subjects were grouped into two groups:\r\nGroup 1 - Methane Eradicators (subjects who eradicated methane on breath test following antibiotic treatment) (N=8) Group 2 - Methane Non-eradicators (subjects who did not eradicate methane on breath test following antibiotic treatment) (N=3)"},{"outcome_type":"primary","measure":"Total Cholesterol Levels Before and After Antibiotic Therapy","time_frame":"Baseline and 1-60 days following completion of antibiotic treatment","description":"Total cholesterol levels were measured in all subjects before and after antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics.Post-treatment blood samples were collected within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days.\r\nFor analysis, subjects were grouped into two groups:\r\nGroup 1 - Methane Eradicators (subjects who eradicated methane on breath test following antibiotic treatment) (N=8) Group 2 - Methane Non-eradicators (subjects who did not eradicate methane on breath test following antibiotic treatment) (N=3)"},{"outcome_type":"primary","measure":"Average Daily Caloric Loss in Stool","time_frame":"Baseline and 1-60 days following completion of antibiotic treatment","description":"The daily caloric loss in stool for each subject was calculated by expressing the total number of kcalories lost in stool over a 3-day period as a percentage of the total number of kcalories ingested over the same 3 days (the number of calories ingested = the number available in meals provided less the number remaining in leftovers). Caloric content for meals, leftovers, and stool was determined by bomb calorimetry. This average daily caloric loss for each group was then compared before and after antibiotic therapy.\r\nPost-treatment caloric harvest studies were performed within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups:\r\nGroup 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8)"},{"outcome_type":"primary","measure":"Gastric Emptying","time_frame":"Baseline and 1-60 days following completion of antibiotic treatment","description":"Gastric Emptying times (minutes) were determined in all subjects before and after antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment gastric emptying studies were performed within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups:\r\nGroup 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8)"},{"outcome_type":"secondary","measure":"Bowel Symptoms - Bloating","time_frame":"Baseline and 1-60 days following completion of antibiotic treatment","description":"Bowel symptom scores on a visual analog scale (VAS) were compared in all subjects before and after antibiotic treatment. Scale values were from 0 to 100, where 0 indicates no symptom and 100 indicates severe symptoms.\r\nAfter baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment symptom scores were obtained within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups:\r\nGroup 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8)"},{"outcome_type":"secondary","measure":"Bowel Symptoms - Abdominal Pain","time_frame":"Baseline and 1-60 days following completion of antibiotic treatment","description":"Bowel symptom scores on a visual analog scale (VAS) were compared in all subjects before and after antibiotic treatment. Scale values were from 0 to 100, where 0 indicates no symptom and 100 indicates severe symptoms.\r\nAfter baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment symptom scores were obtained within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups:\r\nGroup 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8)"},{"outcome_type":"secondary","measure":"Bowel Symptoms - Constipation","time_frame":"Baseline and 1-60 days following completion of antibiotic treatment","description":"Bowel symptom scores on a visual analog scale (VAS) were compared in all subjects before and after antibiotic treatment. Scale values were from 0 to 100, where 0 indicates no symptom and 100 indicates severe symptoms.\r\nAfter baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment symptom scores were obtained within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups:\r\nGroup 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8)"},{"outcome_type":"secondary","measure":"Bowel Symptoms - Diarrhea","time_frame":"Baseline and 1-60 days following completion of antibiotic treatment","description":"Bowel symptom scores on a visual analog scale (VAS) were compared in all subjects before and after antibiotic treatment. Scale values were from 0 to 100, where 0 indicates no symptom and 100 indicates severe symptoms.\r\nAfter baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment symptom scores were obtained within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups:\r\nGroup 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8)"},{"outcome_type":"secondary","measure":"Bowel Symptoms - Straining","time_frame":"Baseline and 1-60 days following completion of antibiotic treatment","description":"Bowel symptom scores on a visual analog scale (VAS) were compared in all subjects before and after antibiotic treatment. Scale values were from 0 to 100, where 0 indicates no symptom and 100 indicates severe symptoms.\r\nAfter baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment symptom scores were obtained within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups:\r\nGroup 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8)"},{"outcome_type":"secondary","measure":"% Stool Dry Weight","time_frame":"Baseline and 1-60 days following completion of antibiotic treatment","description":"% stool dry weight [total stool dry weight (g)/total stool fresh weight (g)] was determined in all subjects before and after antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment stool samples were obtained within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8)"}]}
{"nct_id":"NCT01680211","start_date":"2012-04-30","phase":"N/A","enrollment":40,"brief_title":"Safety and Efficacy Study of Herbal Supplements in Prediabetic and Mild to Moderate Hyperlipidemic Patients","official_title":"Efficacy and Safety Study of Herbal Supplements (SR-L-01, SR-B-01 and SI-S-01) in the Management of Prediabetes and Mild to Moderate Hyperlipidemia","primary_completion_date":"2012-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-06-30","last_update":"2012-09-07","description":"Objective of this study is to determine the safety and efficacy of administration of herbal supplements (Salacia leaf extract, Salacia root extract and Sesame seed extract) for 6 weeks in the management of prediabetes and mild to moderate hyperlipidemia.","other_id":"OL-S-OB-LP/03-12","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. As per ATP III guidelines: Baseline LDL ranging 160-189 mg/dL, TC >200 mg/dL and with\r\n             no or one of the below risk factors\r\n\r\n               -  Current cigarette smoking\r\n\r\n               -  Family history of premature Coronary Heart Disease(CHD); in male first degree\r\n                  relative <55 years; in female first degree relative <65 years)\r\n\r\n               -  Hypertension (BP >140/90 mmHg or on antihypertensive medication)\r\n\r\n               -  Low HDL-C (<40 mg/dL)\r\n\r\n               -  Age (men > 40 years)\r\n\r\n          2. Impaired glucose tolerance (2-hour post 75 g OGTT glucose levels in the range of 140\r\n             to  200 mg/dL)\r\n\r\n          3. Impaired fasting sugar (Fasting blood sugar levels in the range of  100 to 125\r\n             mg/dL)\r\n\r\n          4. Being mentally competent and able to understand all study requirements and sign the\r\n             informed consent form.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients with severe liver, renal, cardiac or brain diseases.\r\n\r\n          2. Pregnant or lactating women or women of child bearing potential whom are not\r\n             practicing a reliable form of birth control (either with IUD or with stable usage of\r\n             oral contraceptives).\r\n\r\n          3. Unable to complete follow up.\r\n\r\n          4. Subjects on any medication that would affect evaluation like Statins.\r\n      ","sponsor":"Olive Lifesciences Pvt Ltd","sponsor_type":"Industry","conditions":"Prediabetes|Hyperlipidemia","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Salacia bark extract"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Salacia leaf extract"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Sesame seed extract"},{"intervention_type":"Behavioral","name":"Behavioral: TLC","description":"Lifestyle changes include diet, exercise, weight loss, etc."},{"intervention_type":"Other","name":"Other: Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"Change in Blood Sugar and lipid profiles","time_frame":"baseline and 6 weeks","description":"Change in of blood sugar out come will be measured by Fasting Blood Sugar (FBS), Oral Glucose Tolerance Test (OGTT) and Postprandial Blood Sugar (PPBS). Change in lipid profiles are measured by Low Density Lipoprotein (LDL), Very Low Density Lipoprotein (VLDL), High Density Lipoprotein (HDL) and Total Cholesterol (TC)."},{"outcome_type":"secondary","measure":"Clinical laboratory evaluations","time_frame":"0 and week 6","description":"Electrocardiography (ECG), haematology (Complete Blood Count), biochemical tests (blood urea, and serum creatinine), liver function tests and urine routine analysis"}]}
{"nct_id":"NCT01779648","start_date":"2012-03-31","phase":"N/A","enrollment":54,"brief_title":"Comparison of Different Intermittent Pneumatic Compression Devices for Deep Vein Thrombosis","official_title":"The Influence of the Different Ways of Pneumatic Compression on Clinical and Physiologic Efficacies in Preventing Deep Vein Thrombosis: a Randomised Comparative Study","primary_completion_date":"2013-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-01-31","last_update":"2013-05-01","description":"Various kinds of intermittent pneumatic compression devices (IPC) with particular ways of compression have been developed and used for prevention of deep vein thrombosis. There are still some controversies about the physiologic properties and clinical impact of numerous issues including the variety of the cuff length, inflation rate, compression sequence, compression-relaxation cycle rate, and pressure generation characteristics. This study is designed to compare clinical efficacies as well as venous hemodynamic improvements between Simultaneous bilateral compression with fixed venous refill time versus alternate compression with adjusted refill time","other_id":"IPCDVT","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  the patients who undergo total knee replacement arthroplasty\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  (1) chronic superficial or deep venous insufficiency, (2) venous anomalies like\r\n             duplication of the superficial femoral vein, (3) previous venous thromboembolism\r\n             history, (4) being under anticoagulation therapy, (5) severe arteriosclerosis\r\n             obliterans without palpable dorsalis pedis pulse, (6) open fracture, hemorrhagic\r\n             condition, or extensive dermatitis at lower legs, (7) congestive heart failure.\r\n             Additional exclusion criteria included a documented malignant tumor, because\r\n             pharmacologic prophylaxis with anticoagulants would be more reasonable in this case.\r\n      ","sponsor":"Seoul National University Hospital","sponsor_type":"Other","conditions":"Venous Thrombosis|Deep Vein Thrombosis","interventions":[{"intervention_type":"Device","name":"Device: DVT-3000"},{"intervention_type":"Device","name":"Device: SCD Express"}],"outcomes":[{"outcome_type":"secondary","measure":"Augmented PV","time_frame":"On 4th postoperative days after total knee replacement arthroplasty","description":"Enhanced peak velocity by application of intermittent pneumatic compression"},{"outcome_type":"secondary","measure":"Augmented MV","time_frame":"On 4th postoperative days after total knee replacement arthroplasty","description":"Enhanced mean velocity by application of pneumatic compression"},{"outcome_type":"primary","measure":"Rate of Deep Vein Thrombosis","time_frame":"On 4th postoperative days after total knee replacement arthroplasty","description":"Computed tomographic angiography were performed on 4th postoperative days to detect deep vein thrombosis and evaluate its extent and location."},{"outcome_type":"secondary","measure":"Peak Velocity","time_frame":"On 4th postoperative days after total knee replacement arthroplasty","description":"Doppler ultrasonography were performed to measure one of the venous hemodynamic parameters to be compared. A longitudinal scans of bilateral superficial femoral veins, just distal to the confluence of the profunda femoral veins, were performed. Baseline velocity, flow pattern, and augmented flow of 11 seconds (Simultaneous compression arm) or 12 seconds (Alternate compression arm) were recorded. Under fixed state of other ultrasound scan parameters, peak velocity (PV) was measured by determination of maximum point of the augmented waveform."},{"outcome_type":"secondary","measure":"Mean Velocity","time_frame":"On 4th postoperative days after total knee replacement arthroplasty","description":"Doppler ultrasonography were performed to measure one of the venous hemodynamic parameters to be compared. A longitudinal scans of bilateral superficial femoral veins, just distal to the confluence of the profunda femoral veins, were performed. Baseline velocity, flow pattern, and augmented flow of 11 seconds (Alternate compression arm) or 12 seconds (Simultaneous compression arm) were recorded. This is an automatically measured mean value of venous flow."},{"outcome_type":"secondary","measure":"Peak Volume Flow","time_frame":"On 4th postoperative days after total knee replacement arthroplasty","description":"Doppler ultrasonography were performed to measure one of the venous hemodynamic parameters to be compared. A longitudinal scans of bilateral superficial femoral veins, just distal to the confluence of the profunda femoral veins, were performed. Baseline velocity, flow pattern, and augmented flow of 11 seconds (Simultaneous compression arm) or 12 seconds (Alternate compression arm) were recorded. Peak volume flow (PVF) was automatically calculated with 1-second interval around the PV."},{"outcome_type":"secondary","measure":"Total Volume Flow","time_frame":"On 4th postoperative days after total knee replacement arthroplasty","description":"Doppler ultrasonography were performed to measure one of the venous hemodynamic parameters to be compared. A longitudinal scans of bilateral superficial femoral veins, just distal to the confluence of the profunda femoral veins, were performed. Baseline velocity, flow pattern, and augmented flow of 11 seconds (Simultaneous compression arm) or 12 seconds (Alternate compression arm) were recorded. Total volume flow (TVF) was automatically calculated by the software."},{"outcome_type":"secondary","measure":"Expelled Total Volume","time_frame":"On 4th postoperative days after total knee replacement arthroplasty","description":"Expelled volume was theoretically calculated value in order to figure out how much blood was squeezed by the compression for an hour; expelled total volume (ETV) = single cycle augmented TVF x cycling rate (cycles/hour)."},{"outcome_type":"secondary","measure":"Expelled Peak Volume","time_frame":"On 4th postoperative days after total knee replacement arthroplasty","description":"Expelled volume was theoretically calculated value in order to figure out how much blood was squeezed by the compression for an hour; expelled peak volume (EPV) = single cycle augmented PVF x cycling rate (cycles/hour)."},{"outcome_type":"secondary","measure":"Augmented PVF","time_frame":"On 4th postoperative days after total knee replacement arthroplasty","description":"Enhanced peak volume flow by application of pneumatic compression"},{"outcome_type":"secondary","measure":"Augmented TVF","time_frame":"on 4th postoperative day after total knee replacement arthroplasty","description":"Enhanced total volume flow by application of pneumatic compression"},{"outcome_type":"secondary","measure":"Cycling Rate","time_frame":"on 4th postoperative day after total knee replacement arthroplasty","description":"Number of cuff inflation-deflation cycle during an hour. In group SF, the cycling rate is fixed as 90 cycles/hour, but in group AA, it is variable according to the individual venous refill time."}]}
{"nct_id":"NCT01556490","start_date":"2012-03-31","phase":"N/A","enrollment":526,"brief_title":"Efficacy Evaluation of TheraSphere in Patients With Inoperable Liver Cancer","official_title":"A Phase III Clinical Trial of Intra-arterial TheraSphere in the Treatment of Patients With Unresectable Hepatocellular Carcinoma (HCC)","primary_completion_date":"2022-09-30","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2022-09-30","last_update":"2021-04-21","description":"The safety and effectiveness of TheraSphere will be evaluated in patients with unresectable hepatocellular carcinoma in whom treatment with standard-of-care sorafenib is planned. All patients receive the standard-of-care sorafenib with or without the addition of TheraSphere.","other_id":"TS-103","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Signed informed consent prior to any study-related evaluation\r\n\r\n          -  Male or female patients over 18 years of age\r\n\r\n          -  Unresectable HCC confirmed by histology or by non-invasive AASLD criteria\r\n\r\n          -  Measurable disease defined as at least one uni-dimensional measurable lesion by CT or\r\n             MRI according to RECIST 1.1\r\n\r\n          -  Child Pugh score  7 points\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) Performance Status score of  1\r\n\r\n          -  Life expectancy of 12 weeks or more\r\n\r\n          -  Eligible to receive standard-of-care sorafenib\r\n\r\n          -  Platelet count of > 50 x 10/L or > 50% prothrombin activity\r\n\r\n          -  Hemoglobin  8.5 g/dL\r\n\r\n          -  Bilirubin  2.5 mg/dL\r\n\r\n          -  Alanine transaminase (ALT) and Aspartate Aminotransferase (AST)< 5 X upper limit of\r\n             normal\r\n\r\n          -  Amylase or lipase  2X upper limit of normal\r\n\r\n          -  Serum creatinine  1.5 X upper limit of normal\r\n\r\n          -  International normalized ratio (INR) < 2.0\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Main portal vein thrombosis\r\n\r\n          -  Eligible for curative treatment (ablation or transplantation)\r\n\r\n          -  History of previous or concurrent cancer other than HCC unless treated curatively 5 or\r\n             more years prior to entry\r\n\r\n          -  Confirmed presence of extra-hepatic disease except lung nodules and mesenteric or\r\n             portal lymph nodes  2.0 cm each\r\n\r\n          -  Risk of hepatic or renal failure\r\n\r\n          -  Tumor replacement  70% of total liver volume based on visual estimation by\r\n             investigator OR tumor replacement  50% of total liver volume in the presence of\r\n             albumin <3 mg/dL\r\n\r\n          -  History of severe allergy or intolerance to contrast agents, narcotics sedatives or\r\n             atropine that cannot be managed medically\r\n\r\n          -  Contraindications to angiography and selective visceral catheterization.\r\n\r\n          -  History of organ allograft\r\n\r\n          -  Known contraindications to sorafenib including allergic reaction, pill-swallowing\r\n             difficulty, evidence of severe or systemic diseases, uncontrolled severe hypertension\r\n             or history of cardiac arrhythmias, congestive heart failure . New York Heart\r\n             Association class 2, myocardial infarct within 6 months, prolonged QT/QTc >450ms,\r\n             evidence of torsades de pointe, or laboratory finding that in the view of the\r\n             investigator makes it undesirable for the patient to participate in the trial,\r\n             significant GI bleed within 30 days, metastatic brain disease, renal failure requiring\r\n             dialysis\r\n\r\n          -  Taking any of the following: Rifampicin, St. John's Wort, phenytoin, carbamazepine,\r\n             phenobarbital, dexamethasone\r\n\r\n          -  Taking any other systemic anticancer agent (docetaxel, doxorubicin, irinotecan)\r\n\r\n          -  Taking any substrate agents for Cytochrome P450 (CYP) 2B6 (bupropion,\r\n             cyclophosphamide, efavirenz, ifosfamide, methadone, paclitaxel, amodiaquine,\r\n             repaglinide)\r\n\r\n          -  Taking any UDP-glucuronosyltransferase (UGT) 1A1 and UGT 1A9 substrates (e.g.\r\n             irinotecan)\r\n\r\n          -  Taking P-Gp substrates (e.g. Digoxin)\r\n\r\n          -  Prior liver resection must have taken 2 months prior to randomization\r\n\r\n          -  Treatment with other locoregional therapies (other than study treatment) has not been\r\n             planned for the duration of the clinical study period\r\n\r\n          -  Prior external beam radiation treatment to the chest, liver or abdomen\r\n\r\n          -  Prior yttrium-90 microsphere treatment to the liver\r\n\r\n          -  Prior treatment with transarterial chemoembolization (TACE) or bland embolization must\r\n             have occurred >2 months prior to randomization and must have been applied to a\r\n             treatment field and/or lobe not targeted for treatment under this protocol. For\r\n             patients with tumor progression in the treatment field and /or lobe previously treated\r\n             with TACE, vessels feeding the tumor(s) must be assessed for adequate blood flow using\r\n             angiography (cone beam computerized tomography (CBCT) strongly recommended), and TACE\r\n             or bland embolization must have been applied >6 months prior to randomization.\r\n\r\n          -  Anti-cancer therapy or any treatment with an investigational agent within 30 days\r\n             prior to randomization\r\n\r\n          -  Adverse effects due to prior therapy unresolved at randomization\r\n\r\n          -  Prior systemic treatment for the treatment of HCC, including sorafenib given for more\r\n             than 4 weeks during the 2 previous months prior to randomization, no prior sorafenib\r\n             related toxicity\r\n\r\n          -  Evidence of pulmonary insufficiency or inadequately treated moderate grade or\r\n             severe/very severe grade chronic obstructive pulmonary disease\r\n\r\n          -  Intervention for, or compromise of, the Ampulla of Vater\r\n\r\n          -  Clinically evident ascites (trace ascites on imaging is acceptable)\r\n\r\n          -  Pregnancy or breast feeding\r\n\r\n          -  Women of child-bearing potential must have a negative serum pregnancy test within 14\r\n             days prior to randomization\r\n\r\n          -  Disease or condition that would preclude safe use of TheraSphere, including concurrent\r\n             dialysis treatment, or unresolved serious infections. Patients infected with HIV can\r\n             be considered, however, they must be well managed and well controlled with\r\n             undetectable viral load\r\n\r\n          -  Participation in concurrent clinical trials evaluating treatment intervention(s)\r\n      ","sponsor":"Boston Scientific Corporation","sponsor_type":"Industry","conditions":"Unresectable Hepatocellular Carcinoma","interventions":[{"intervention_type":"Device","name":"Device: TheraSphere","description":"Yttrium 90 microspheres"}],"outcomes":[{"outcome_type":"primary","measure":"Overall survival","time_frame":"From time of randomization up to 45 months","description":"The interval between the randomization date and the date of death for any cause"}]}
{"nct_id":"NCT01558895","start_date":"2012-03-31","phase":"Phase 2/Phase 3","enrollment":40,"brief_title":"Infrared Ray Heat Treatment in Liver Cirrhosis Patients With Refractory Ascites","official_title":"Infrared Ray Heat Treatment in Hepatic Area in Liver Cirrhosis Patients With Refractory Ascites","primary_completion_date":"2013-03-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2013-04-30","last_update":"2012-03-21","description":"The objective of this study is to evaluate the therapeutic efficacy of Infrared ray heat treatment in hepatic area in cirrhosis patients with refractory ascites. The evaluation of the efficacy includes the ascites pressure, portal vein velocitySAAG before and after the treatment. Clinical symptoms were also observed simultaneously.","other_id":"FS-001","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male\r\n\r\n          -  aged 18~60 years\r\n\r\n          -  inpatient\r\n\r\n          -  Diagnosed with liver cirrhosis and liver stubborn ascites.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Severe problems in other vital organs(e.g.the heart,renal or lungs).\r\n\r\n          -  combined with malignant tumour.\r\n\r\n          -  combined with endocrine diseases.\r\n\r\n          -  combined with high fever.\r\n\r\n          -  infected with the AIDS virus\r\n      ","sponsor":"First People's Hospital of Foshan","sponsor_type":"Other","conditions":"Liver Cirrhosis|Refractory Ascites","interventions":[{"intervention_type":"Radiation","name":"Radiation: Infrared ray heat treatment","description":"Patients in experimental group accepted Infrared ray heat treatment in hepatic area for 30 minutes as well as conventional therapy."},{"intervention_type":"Other","name":"Other: conventional treatment","description":"Conventional treatment consists of antiviral drugs, lowering aminotransferase and jaundice medicine."}],"outcomes":[{"outcome_type":"primary","measure":"ascites pressure","time_frame":"30 min","description":"use the invasive pressure sensor to estimate the ascites pressure before and after the Infrared ray heat treatment."}]}
{"nct_id":"NCT01558622","start_date":"2012-03-31","phase":"Phase 4","enrollment":72,"brief_title":"Intraoperative Use of Dexketoprofen Trometamol, Pethidine Hcl, Tramadol Hcl and Their Combinations for Postoperative Pain Management in Laparoscopic Nissen Fundoplication","official_title":"Intraoperative Use of Dexketoprofen Trometamol, Tramadol Hcl, Pethidine Hcl and Their Combinations for Postoperative Pain Management in Laparoscopic Nissen Fundoplication","primary_completion_date":"2012-05-31","study_type":"Interventional","rec_status":"Unknown status","last_update":"2012-03-23","description":"The purpose of this study is to evaluate the analgesic effects of dexketoprofen trometamol, tramadol hydrochloride, pethidine hydrochloride and their combinations in laparoscopic Nissen fundoplication.","other_id":"KVDU 0001 GG","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18-60 years old ASA I-II patients\r\n\r\n          -  Clinical diagnosis of gastroesophageal reflux patients\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Allergic reactions to NSAIDs or opioid analgesics\r\n\r\n          -  Body mass index exceeding 35\r\n\r\n          -  Pregnancy\r\n      ","sponsor":"Kavakldere Umut Hospital","sponsor_type":"Other","conditions":"Laparoscopic Nissen Fundoplication","interventions":[{"intervention_type":"Drug","name":"Drug: dexketoprofen trometamol","description":"50mg intravenous infusion"},{"intervention_type":"Drug","name":"Drug: tramadol hydrochloride","description":"100mg intravenous infusion"},{"intervention_type":"Drug","name":"Drug: pethidine hydrochloride","description":"50mg intravenous infusion"},{"intervention_type":"Drug","name":"Drug: dexketoprofen trometamol + tramadol hydrochloride","description":"intravenous infusion of 50mg dexketoprofen trometamol + 100mg tramadol hydrochloride"},{"intervention_type":"Drug","name":"Drug: dexketoprofen trometamol + pethidine hydrochloride","description":"intravenous infusion of 50mg dexketoprofen trometamol + 50mg pethidine hydrochloride"},{"intervention_type":"Drug","name":"Drug: vitamin c","description":"500mg intravenous infusion"}],"outcomes":[{"outcome_type":"primary","measure":"Allergic reactions to NSAIDs or opioid analgesics, body mass index exceeding 35","time_frame":"postoperative 2 hours"}]}
{"nct_id":"NCT01923155","start_date":"2012-03-31","phase":"N/A","enrollment":731,"brief_title":"Safety & Effectiveness of Nurse Performed Colonoscopies Under Supervision","official_title":"Safety & Effectiveness of Nurse Performed Colonoscopies Under Supervision: A Randomized Controlled Study in Asia (NE Study)","primary_completion_date":"2013-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-06-30","last_update":"2013-08-15","description":"There is no theoretical or practical reason why non-medical personnel such as nurses could not be trained to perform diagnostic colonoscopy with comparable proficiency as medical endoscopists. Nurse endoscopists have been widely accepted in the United Kingdom for the past 15 years as a valuable resource to cope with the increasing demand for endoscopic service, in particular diagnostic colonoscopy for colorectal screening. A pilot study performed in Hong Kong in 2008 has shown that endoscopy nurses can be trained to perform diagnostic endoscopy safely and reliably. This study aims to demonstrate that properly trained nurse endoscopists have a comparable proficiency in performing colonoscopy procedures as their medical counterparts.","other_id":"NE","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  1. Subjects receiving screening colonoscopy\r\n\r\n          -  2. Age  18\r\n\r\n          -  3. Informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  1. Subjects have undergone colonoscopy in the past 5 years\r\n\r\n          -  2. Patients with prior colorectal surgery\r\n\r\n          -  3. Subjects with a personal history of inflammatory bowel disease, colon adenoma or\r\n             cancer or family history of Familial Adenomatous Polyposis or Familial non-polyposis\r\n             syndrome\r\n\r\n          -  4. Pregnant or lactating women\r\n\r\n          -  5. Lack of consent\r\n      ","sponsor":"Chinese University of Hong Kong","sponsor_type":"Other","conditions":"Colorectal Cancer","interventions":[{"intervention_type":"Procedure","name":"Procedure: Colonoscopy"}],"outcomes":[{"outcome_type":"secondary","measure":"Complication rate","time_frame":"Up to 3 months"},{"outcome_type":"secondary","measure":"Patients pain score","time_frame":"Up to 3 months"},{"outcome_type":"secondary","measure":"Patients overall satisfactory score","time_frame":"Up to 3 months"},{"outcome_type":"secondary","measure":"Cecal intubation TIME","time_frame":"up to 3 months"},{"outcome_type":"primary","measure":"Adenoma detection rate","time_frame":"Up to 3 months"},{"outcome_type":"secondary","measure":"Cecal intubation RATE","time_frame":"Up to 3 months"},{"outcome_type":"secondary","measure":"Withdrawal time","time_frame":"Up to 3 months"}]}
{"nct_id":"NCT01550367","start_date":"2012-03-31","phase":"Phase 1/Phase 2","enrollment":30,"brief_title":"Study of Hydroxychloroquine and Aldesleukin in Renal Cell Carcinoma Patients (RCC)","official_title":"Inhibiting the Systemic Autophagic Syndrome - A Phase I/II Study of Hydroxychloroquine and Aldesleukin in Renal Cell Carcinoma Patients (RCC). A Cytokine Working Group (CWG) Study","primary_completion_date":"2018-02-06","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-02-28","last_update":"2020-01-02","description":"The main goal of the research study is to determine whether treating renal cell cancer patients with the study drug, hydroxychloroquine, along with IL-2, a standard treatment of kidney cancer that has spread to other parts of the body, can make the cancer easier to kill and eliminate. Another goal is to see how the study drug affects the body's immune cells which fight cancer cells.","other_id":"UPCI 11-080","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically confirmed metastatic renal cell carcinoma with predominantly clear cell\r\n             histology.\r\n\r\n          -  Have measurable disease by RECIST 1.1 criteria. For example, this would include tumor\r\n             in the lung, liver, and retroperitoneum. Bone disease is difficult to follow and\r\n             quantify and as a sole site would not be acceptable.\r\n\r\n          -  Patients must be at least 4 weeks from radiation or surgery and recovered from all ill\r\n             effects.\r\n\r\n          -  Age 18 years.\r\n\r\n          -  Karnofsky Performance Status 80%.\r\n\r\n          -  Adequate end organ function:\r\n\r\n               1. Hematologic: ANC  1000cells/uL, platelets  100,000/uL, hemoglobin  9g/dl (pre\r\n                  transfusion values used for prognostic factor, can be transfused or use\r\n                  recombinant erythropoietin growth factors but must not have active bleeding).\r\n\r\n               2. Liver: AST  2 x ULN (upper limit of normal), serum total bilirubin  2 x ULN\r\n                  (except for patients with Gilbert's Syndrome).\r\n\r\n               3. Renal: serum creatinine  1.5 mg/dL or estimated creatinine clearance  60ml/min\r\n                  using Cockcroft-Gault estimation using the formula per protocol.\r\n\r\n               4. Pulmonary: FEV1  2.0 liters or  75% of predicted for height and age. (PFTs are\r\n                  required for patients over 50 or with significant pulmonary or smoking history\r\n                  defined as >20 pack years or history of COPD/emphysema).\r\n\r\n               5. Cardiac: No evidence of congestive heart failure, symptoms of coronary artery\r\n                  disease, myocardial infarction less than one year prior to entry, serious cardiac\r\n                  arrhythmias, or unstable angina. Patients who are over 40 or have had previous\r\n                  cardiac disease will be required to have a negative or low probability cardiac\r\n                  stress test for cardiac ischemia.\r\n\r\n          -  Women should not be lactating and, if of childbearing age, have a negative pregnancy\r\n             test within two weeks of entry to the study.\r\n\r\n          -  Appropriate contraception in both genders.\r\n\r\n          -  The patient must be competent and have signed informed consent.\r\n\r\n          -  CNS: No history of cerebrovascular accident, transient ischemic attacks, central\r\n             nervous system or brain metastases.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who have previously received IL-2 are NOT eligible. Patients on HCQ in\r\n             neoadjuvant protocols or in the past for clinical indications ARE eligible, as are\r\n             patients who have previously received CTLA-4 and/or PD-1/PD-L1 antibodies.\r\n\r\n          -  Concomitant second malignancy except for non-melanoma skin cancer, and non-invasive\r\n             cancer such as cervical CIS, superficial bladder cancer without local recurrence or\r\n             breast CIS.\r\n\r\n          -  In patients with a prior history of invasive malignancy, less than five years in\r\n             complete remission.\r\n\r\n          -  Positive serology for HIV, hepatitis B or hepatitis C.\r\n\r\n          -  Significant co-morbid illness such as uncontrolled diabetes or active infection that\r\n             would preclude treatment on this regimen.\r\n\r\n          -  Use of corticosteroids or other immunosuppression (if patient had been taking\r\n             steroids, at least 2 weeks must have passed since the last dose).\r\n\r\n          -  History of inflammatory bowel disease or other serious autoimmune disease. (Not\r\n             including thyroiditis and rheumatoid arthritis). Patients already on\r\n             hydroxychloroquine for such disorders are not eligible.\r\n\r\n          -  Patients with organ allografts.\r\n\r\n          -  Uncontrolled hypertension (BP >150/100 mmHg).\r\n\r\n          -  Proteinuria dipstick > 3+ or  2gm/24 hours.\r\n\r\n          -  Urine protein:creatinine ratio  1.0 at screening.\r\n\r\n          -  Major surgery, open biopsy, significant traumatic injury within 28 days of starting\r\n             treatment or anticipation of need for major surgical procedure during the course of\r\n             the study.\r\n\r\n          -  Minor surgical procedures, fine needle aspirations or core biopsies within 7 days\r\n             prior to starting treatment. Central venous catheter placements are permitted.\r\n\r\n          -  History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess\r\n             within 6 months prior to starting treatment.\r\n\r\n          -  Serious, non-healing wound, ulcer, or bone fracture.\r\n\r\n          -  History of tumor-related or other serious hemorrhage, bleeding diathesis, or\r\n             underlying coagulopathy.\r\n\r\n          -  History of deep venous thrombosis, clinically significant peripheral vascular disease,\r\n             or other thrombotic event.\r\n\r\n          -  Inability to comply with study and/or follow-up procedures.\r\n\r\n          -  Individuals with known history of glucose 6 phosphate deficiency are excluded from the\r\n             trial (possible issue with HCQ tolerance).\r\n\r\n          -  Patients with previously documented macular degeneration or diabetic retinopathy are\r\n             excluded from the trial.\r\n\r\n          -  Baseline EKG with QTc > 470 msec (including subjects on medication). Subjects with\r\n             ventricular pacemaker for whom QT interval is not measurable will be eligible on a\r\n             case-by-case basis.\r\n      ","sponsor":"Leonard Appleman","sponsor_type":"Other","conditions":"Metastatic Renal Cell Carcinoma","interventions":[{"intervention_type":"Drug","name":"Drug: Hydroxychloroquine","description":"Continuous oral administration (at 600 mg/d) will be initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses."},{"intervention_type":"Drug","name":"Drug: IL-2","description":"600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course"}],"outcomes":[{"outcome_type":"secondary","measure":"Prior Nephrectomy","time_frame":"Up to 3 years","description":"Number of patients with history of a prior nephrectomy (surgical removal of a kidney) or no history of a prior nephrectomy."},{"outcome_type":"secondary","measure":"Serum Calcium Levels (Corrected)","time_frame":"Up to 3 years","description":"Number of patients with either normal or high serum calcium levels. High serum calcium levels are considered to be clinically unfavorable."},{"outcome_type":"secondary","measure":"Conventional Dendritic Cells (cDC)","time_frame":"Up to 3 years","description":"Percentage of Conventional Dendritic Cells (cDC) per ml of blood. cDC reside in tissues and once activated, migrate to draining lymph nodes to promote adaptive immune responses."},{"outcome_type":"primary","measure":"Clinical Response - IL-2 Combined With Hydroxychloroquine (HCQ) at Either 1,200 mg/d or 600 mg/d) (All Patients)","time_frame":"Up to 3 years","description":"Clinical Response: per RECIST v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to <10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression."},{"outcome_type":"primary","measure":"Clinical Response - IL-2 Combined With Hydroxychloroquine (HCQ) at 1,200 mg/d","time_frame":"Up to 3 years","description":"Clinical Response: per RECIST v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to <10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression."},{"outcome_type":"primary","measure":"Clinical Response - IL-2 Combined With Hydroxychloroquine (HCQ) at 600 mg/d","time_frame":"Up to 3 years","description":"Clinical Response: per RECIST v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to <10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression."},{"outcome_type":"secondary","measure":"Overall Survival (OS)","time_frame":"Up to 3 years","description":"Time from date of first protocol treatment until the date of death, or censored at date of last contact."},{"outcome_type":"secondary","measure":"Progression-free Survival (PFS)","time_frame":"Up to 3 years","description":"Time from the date of first protocol treatment until the date disease progression criteria are met (in responding patients progression criteria uses the reference of the smallest measurements recorded since the treatment started) or is censored at date of last disease assessment for those who have not progressed. Per RECIST 1.1, Progressive Disease (PD) is defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression."},{"outcome_type":"secondary","measure":"Number of Doses of IL-2 + HCQ","time_frame":"Up to 3 years","description":"Number of doses of IL-2 administered during the first course of therapy."},{"outcome_type":"secondary","measure":"Frequency of Grade III and Grade IV Toxicities","time_frame":"Up to 3 years","description":"Number of specified categories of grade III and IV or unexpected or rare toxicities occurring during the first course (up until the end of cycle 1) of IL-2 treatment."},{"outcome_type":"secondary","measure":"Worst Grade of Adverse Event Experienced","time_frame":"Up to 3 years","description":"Number of participants who experienced Grade 2-5 adverse events."},{"outcome_type":"secondary","measure":"Worst Grade of Adverse Event At Least Possibly Related to Treatment Experienced","time_frame":"Up to 3 years","description":"Number of participants who experienced Grade 2-5 adverse events that were at least possibly related to study treatment."},{"outcome_type":"secondary","measure":"Worst Grade of Adverse Event At Least Probably Related to Treatment Experienced","time_frame":"Up to 3 years","description":"Number of participants who experienced Grade 2-5 adverse events that were at least probably related to study treatment."},{"outcome_type":"secondary","measure":"Serum Lactate Dehydrogenase","time_frame":"Up to 2 years","description":"Number of participants with either high serum lactate dehydrogenase (> 1.5 times upper limit of normal) or normal lactate dehydrogenase."},{"outcome_type":"secondary","measure":"Hemoglobin Levels","time_frame":"Up to 3 years","description":"Low hemoglobin levels (less than the lower limit of normal (13.2 g/dL)) are considered to be unfavorable."},{"outcome_type":"secondary","measure":"Number of Participants With Low Karnofsky Performance Status","time_frame":"Up to 3 years","description":"Karnofsky performance status is a standard way of measuring the ability of cancer patients to perform ordinary tasks. The Karnofsky Performance Status scores range from 0 to 100. A higher score means the patient is better able to carry out daily activities. Karnofsky Performance Status may be used to determine a patient's prognosis, to measure changes in a patient's ability to function, or to decide if a patient should be included in the trial. A low Karnofsky performance status (<80%) is considered to be unfavorable."},{"outcome_type":"secondary","measure":"Natural Killer (NK) Cells","time_frame":"Up to 3 years","description":"Percentage of Natural Killer (NK) cells per ml of blood. NK cells are lymphocytes with the ability to kill tumor cells without deliberate immunization or activation."},{"outcome_type":"secondary","measure":"Myeloid Derived Suppressor Cell (MDSC)","time_frame":"Up to 3 years","description":"Percentage of Myeloid Derived Suppressor Cell per ml of blood. MDSC immune cells originate from bone marrow stem cells and strongly expand in cancer."},{"outcome_type":"secondary","measure":"Regulatory T Cells (Treg)","time_frame":"Up to 3 years","description":"Percentage of Regulatory T cells per ml of blood. High levels of Tregs in the tumor microenvironment are associated with poor prognosis in many cancers by suppressing the body's anti-tumor immune response."},{"outcome_type":"secondary","measure":"Plasmacytoid Dendritic Cells (pDC)","time_frame":"Up to 3 years","description":"Percentage of Plasmacytoid dendritic cells per ml of blood. In cancer, pDC are malignant immune cells that demonstrate an impaired response that can contribute to the establishment of an immunosuppressive tumor microenvironment."},{"outcome_type":"secondary","measure":"T-cell Lymphocytes","time_frame":"Up to 3 years","description":"Percentage of T-cell lymphocytes in blood as cells per ml. T-cells are a subtype of white blood cells which play a key role in the immune system and fighting cancer."}]}
{"nct_id":"NCT01542762","start_date":"2012-03-31","phase":"N/A","enrollment":1500,"brief_title":"Pot-Cast: Thrombosis Prophylaxis During Plaster Cast Lower Leg Immobilisation","official_title":"Pot-Cast: Thrombosis Prophylaxis During Plaster Cast Lower Leg Immobilisation: Determining the Balance Between Benefits and Risks","primary_completion_date":"2016-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-09-30","last_update":"2016-10-11","description":"Currently, guidelines and clinical practice differ considerably with respect to use of anticoagulant treatment during cast immobilization of the lower leg. Trials that have been carried out were aimed at efficacy only, had small sample sizes and therefore mainly used asymptomatic thrombosis as endpoint. From these trials an overall risk benefit-balance could not be established, hence the current controversy. In the proposed study the investigators will use relevant symptomatic endpoints in a large cohort of patients. Furthermore the investigators will follow subjects with an adverse event for a longer period, during which the investigators will assess the long term sequelae of these events. Lastly, the investigators will determine high risk groups that will benefit most from anticoagulant treatment. Objective: Comparative effectiveness research to determine cost-effectiveness of two existing policies, i.e. treatment with low molecular weight heparin (LMWH) during lower leg plaster cast immobilization following surgical or conservative treatment. In addition the investigators will investigate personalized prophylaxis based on genetic and acquired risk factors.","other_id":"NL35774.058.11","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        All patients in need of immobilization of the lower leg with a plaster cast (or equivalent\r\n        of a cast) for a minimum of one week for the following indications:\r\n\r\n          -  Trauma of the lower leg\r\n\r\n          -  Surgery of the lower leg followed by lower leg immobilization with a plaster cast\r\n\r\n          -  Non-traumatic indications\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Contra-indications for LMWH use (recent major bleeding, bleeding disorder, allergy)\r\n\r\n          -  Pregnancy\r\n\r\n          -  Pre-existent indication for anticoagulation therapy, either LMWH or vitamin K\r\n             antagonists.\r\n\r\n          -  History of venous thromboembolism (indication for anticoagulation therapy for\r\n             prophylaxis of recurrence)\r\n\r\n          -  Mental of physical disability to fulfill study requirements\r\n\r\n          -  Insufficient knowledge of the Dutch language\r\n\r\n          -  Previous participation in the Pot-(K)Cast study\r\n      ","sponsor":"Suzanne C. Cannegieter, MD PhD","sponsor_type":"Other","conditions":"Deep Venous Thrombosis|Pulmonary Embolism","interventions":[{"intervention_type":"Drug","name":"Drug: LMWH","description":"Each hospital will use a LMWH according to their own preferences.\r\nProphylactic dosage of LMWH (for example nadroparin 2850 IE s.c.) once daily for the duration of the immobilization (average 6 weeks). If the patient's weight is more than 100kg a double dose of LMWH will be given (in case of Nadroparin 5700 IE s.c. once daily)."}],"outcomes":[{"outcome_type":"primary","measure":"Symptomatic deep venous thrombosis (DVT)","time_frame":"3 Months","description":"Symptomatic deep venous thrombosis confirmed with compression ultrasonography"},{"outcome_type":"primary","measure":"Pulmonary Embolism (PE)","time_frame":"3 months","description":"Fatal or non-fatal pulmonary embolism confirmed with:\r\nan intraluminal filling defect in segmental or more proximal branches on spiral CT scan, or\r\na perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan, or\r\ndetected at autopsy"},{"outcome_type":"primary","measure":"Major Bleeding","time_frame":"3 months","description":"Major bleeding, defined as:\r\na fatal bleeding, or\r\nsymptomatic bleeding in a critical area or organ, or\r\nextrasurgical site bleeding causing a fall in hemoglobin level of 1.24mmol/L (2.0g/dL) or more, leading to transfusion of one or more units of whole blood or red cells, or\r\nsurgical site bleeding that requires a second intervention or a hemarthrosis interfering with rehabilitation, or surgical site bleeding that needs blood suppletion."},{"outcome_type":"secondary","measure":"Other clinically relevant bleeding","time_frame":"3 months","description":"Other clinically relevant bleeding, defined as overt bleeding not meeting the criteria for major bleeding but associated with medical intervention, unscheduled contact with a physician, (temporary) cessation of study treatment, or associated with discomfort such as pain, or impairment of activities of daily life."},{"outcome_type":"secondary","measure":"Surgical site infection","time_frame":"3 months","description":"Superficial incisional surgical site infection, deep incisional surgical site infection of organ/space surgical site infection according to the definitions of the CDC."}]}
{"nct_id":"NCT01576016","start_date":"2012-03-30","phase":"N/A","enrollment":950,"brief_title":"Safety and Efficacy of the Accent Magnetic Resonance Imaging (MRI) Pacemaker and Tendril MRI Lead","official_title":"Accent Magnetic Resonance Imaging Pacemaker and Tendril Magnetic Resonance Imaging Lead Investigational Device Exemption Study","primary_completion_date":"2018-02-02","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-02-02","last_update":"2020-11-10","description":"The MRI Study is a prospective, multi-center, clinical study designed to evaluate the safety and efficacy of the Accent MRI System in a patient population indicated for implant of a pacemaker within and outside of the MRI environment.","other_id":"60028820","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Eligible patients will meet all of the following:\r\n\r\n          1. Have an approved indication per American College of Cardiology (ACC)/American Heart\r\n             Association (AHA)/Heart Rhythm Society (HRS) guidelines for implantation of a\r\n             pacemaker\r\n\r\n          2. Will receive a new pacemaker and lead\r\n\r\n          3. Be willing to undergo an elective MRI scan without sedation\r\n\r\n          4. Be able to provide informed consent for study participation (legal guardian is NOT\r\n             acceptable)\r\n\r\n          5. Be willing and able to comply with the prescribed follow-up tests and schedule of\r\n             evaluations\r\n\r\n          6. Is not contraindicated for an MRI scan (per the pre-MRI safety screening form)\r\n\r\n        Exclusion Criteria:\r\n\r\n        Patients will be excluded if they meet any of the following:\r\n\r\n          1. Are medically indicated for an MRI scan at the time of enrollment\r\n\r\n          2. Have an existing pacemaker or implantable cardioverter defibrillator (ICD). A new\r\n             pacemaker and lead is required for enrollment\r\n\r\n          3. Have an existing active/inactive implanted medical device, e.g., neurostimulator,\r\n             infusion pump, etc.\r\n\r\n          4. Have a non-MRI compatible device or material implanted (e.g., intracranial aneurysm\r\n             clip, non-MRI compatible devices or material, metals or alloys, etc.)\r\n\r\n          5. Have a lead extender or adaptor\r\n\r\n          6. Be unable to fit in MRI bore; will come into contact with the magnet faade inside the\r\n             MRI bore.\r\n\r\n          7. Have a prosthetic tricuspid heart valve\r\n\r\n          8. Are currently participating in a clinical investigation that includes an active\r\n             treatment arm\r\n\r\n          9. Are allergic to dexamethasone sodium phosphate (DSP)\r\n\r\n         10. Are pregnant or planning to become pregnant during the duration of the study\r\n\r\n         11. Have a life expectancy of less than 12 months due to any condition\r\n\r\n         12. Patients with exclusion criteria required by local law (e.g., age)\r\n\r\n         13. Are unable to comply with the follow up schedule\r\n      ","sponsor":"Abbott Medical Devices","sponsor_type":"Industry","conditions":"Adverse Effect of MRI on an Implanted Pacemaker Lead|Adverse Effect of MRI on an Implanted Pacemaker","interventions":[{"intervention_type":"Device","name":"Device: Accent MRI system (lead safety)","description":"Patients implanted with an Accent MRI system"},{"intervention_type":"Device","name":"Device: Accent MRI system (with MRI scan)","description":"Patients implanted with an Accent MRI system will receive an MRI scan"}],"outcomes":[{"outcome_type":"primary","measure":"Freedom From Right Atrial (RA) Lead-related Complications in the Acute Period","time_frame":"Implant through 2 months","description":"Percentage of patients who do not have RA lead-related complications from implant through the 2 month study visit"},{"outcome_type":"primary","measure":"Freedom From Right Ventricular (RV) Lead-related Complications in the Acute Time Period","time_frame":"Implant through 2 months","description":"Percentage of patients who do not have RV lead-related complications from implant through the 2 month study visit"},{"outcome_type":"primary","measure":"Freedom From RA Related Complications in the Chronic Period","time_frame":"2 months through 12 months","description":"Percentage of patients who do not have RA lead-related complications from the 2 month through the 12 month study visit"},{"outcome_type":"primary","measure":"Freedom From Right Ventricular Lead Related Complications in the Chronic Period","time_frame":"2 months through 12 months","description":"Percentage of patients who do not have RV lead-related complications from the 2 month through the 12 month study visit"},{"outcome_type":"primary","measure":"Freedom From MRI Scan-related Complications","time_frame":"MRI Scan visit through 1 month after MRI scan visit","description":"Percentage of patients who do not have MRI-related complications from the MRI scan visit to the 1 month post MRI scan visit"},{"outcome_type":"primary","measure":"Change in Atrial Capture Threshold From Pre to Post MRI Scan","time_frame":"MRI Scan visit to 1 month after MRI scan visit","description":"Percentage of patients with an increase in RA capture thresholds of <= 0.5 V, at a pulse width of 0.5 ms ."},{"outcome_type":"primary","measure":"Change in Ventricular Capture Threshold Pre to Post MRI Scan","time_frame":"MRI Scan visit to 1 month after MRI scan visit","description":"Percentage of patients with an increase in RV capture thresholds of <=0.5V, at a pulse width of 0.5 ms."},{"outcome_type":"primary","measure":"Change in Atrial Sense Amplitude","time_frame":"MRI Scan visit to 1 month after MRI scan visit","description":"Percentage of patients with a reduction in RA sense amplitude <=50 % and sense amplitude >=1.5 mV."},{"outcome_type":"primary","measure":"Change in Ventricular Sense Amplitude","time_frame":"MRI Scan visit to 1 month after the MRI Scan visit","description":"Percentage of patients with an reduction in RV sense amplitude <=50% and sense amplitude >=5 mV."},{"outcome_type":"secondary","measure":"Freedom From System-related Complications","time_frame":"Implant through 12 months","description":"Percentage of patients who do not have system-related complications from implant through the 12 month study visit"},{"outcome_type":"secondary","measure":"Atrial Capture Threshold at the MRI Visit","time_frame":"MRI Scan visit (approx 3 months post implant)","description":"Percentage of patients with RA capture threshold ≤2.0 volts (V) at the MRI visit"},{"outcome_type":"secondary","measure":"Ventricular Capture Threshold at the MRI Visit","time_frame":"MRI Scan visit (approx 3 months post implant)","description":"Percentage of patients with RV capture threshold ≤2.0 V at the MRI visit"}]}
{"nct_id":"NCT01695863","start_date":"2012-02-29","phase":"Phase 4","enrollment":150,"brief_title":"Efficacy and Patient Satisfaction of Miralax and Gatorade Versus Movi Prep","official_title":"Phase 4 of Efficacy and Patient Satisfaction of Miralax and Gatorade Versus Movi Prep","primary_completion_date":"2012-11-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2013-06-30","last_update":"2013-03-21","description":"This study will be comparing patient satisfaction, efficacy comparing miralax with gatorade versus Movi Prep for outpatient colonoscopy.","other_id":"11042705","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Screening","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  outpatient colonoscopy for screening for other Gi related problems\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Severe CHF,\r\n\r\n          -  CKD,\r\n\r\n          -  less than age 18 or more than 80 years\r\n      ","sponsor":"Rush University Medical Center","sponsor_type":"Other","conditions":"Colorectal Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: comparing 2 drugs on their effect on the bowel preparation for colonoscopy","description":"the effects of the drug on the colon preparation for colonoscopy"}],"outcomes":[{"outcome_type":"primary","measure":"bowel prep efficacy","time_frame":"8 months","description":"To assess the bowel prep efficacy in cleansing the colon for colonoscopy"},{"outcome_type":"secondary","measure":"assess change in renal function pre and post bowel prep","time_frame":"8 months","description":"changes in electrolytes pre and post bowel preparation administration"}]}
{"nct_id":"NCT01495455","start_date":"2012-02-29","enrollment":140,"brief_title":"Nottingham Osteoarthritis Biomarker Study 2011","official_title":"Nottingham Osteoarthritis Biomarker Study 2011","primary_completion_date":"2013-01-31","study_type":"Observational","rec_status":"Completed","completion_date":"2013-01-31","last_update":"2013-01-30","description":"Osteoarthritis is by far the most common joint condition and the single largest cause of disability in the older population. The investigators still have a poor understanding of the nature of osteoarthritis and factors that influence its development and progression. Identification of biochemical markers that relate to cartilage loss, bony overgrowth and other features that occur with osteoarthritis will advance our understanding. Over the last 5 years analytical methods have developed to measure a range of different biomarkers. This pilot study will use these analytical methods to measure biomarker levels in joint fluid, urine and blood of 50 participants with Osteoarthritis (OA) and 50 healthy volunteers. This study will provide novel pilot data on the changes in the composition of the synovial fluid, urine and blood in patients with OA. Apart from being a key target site for OA, the knee is a suitable joint for study because of its accessibility to clinical assessment, joint aspiration and imaging.","other_id":"11049","observational_model":"Case-Control","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":30,"population":"- Secondary care clinics","criteria":"\n        Inclusion Criteria:\r\n\r\n        All participants:\r\n\r\n          -  Be able to provide written informed consent\r\n\r\n          -  Aged 30 and over\r\n\r\n        Knee OA patients:\r\n\r\n         Radiographic signs of OA - that is definite joint space narrowing plus osteophyte in at\r\n        least one compartment of the knee\r\n\r\n        Normal controls:\r\n\r\n          -  No knee pain\r\n\r\n          -  No clinical or radiographic changes of knee OA\r\n      ","sponsor":"University of Nottingham","sponsor_type":"Other","conditions":"Osteoarthritis","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Difference in the levels of pro-inflammatory and anti-inflammatory lipids mediators between individuals with knee osteoarthritis and those with normal knees.","time_frame":"within 6 months of recruitment of last participant"}]}
{"nct_id":"NCT01429259","start_date":"2012-02-29","phase":"Phase 4","enrollment":30,"brief_title":"Population Pharmacokinetics of Prolonged Infusion Meropenem in Cystic Fibrosis (CF) Children","official_title":"An Open Label Study to Assess the Population Pharmacokinetics, Safety, and Practicality of Administering Meropenem as a Prolonged Infusion to Cystic Fibrosis Children Admitted With an Acute Pulmonary Exacerbation","primary_completion_date":"2014-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-01-31","last_update":"2018-03-20","description":"This study will determine the concentrations of the antibiotic meropenem when administered as a 3 hour prolonged infusion in children with cystic fibrosis who are hospitalized with an acute pulmonary exacerbation. Safety and practicality of administering meropenem as a 3 hour infusion will be measured.","other_id":"KUTI003498HE","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":6,"maximum_age":17,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Cystic Fibrosis\r\n\r\n          -  Hospitalized with acute pulmonary exacerbation\r\n\r\n          -  Caused by Pseudomonas aeruginosa or other bacteria against which meropenem would be an\r\n             appropriate antibiotic treatment\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Known allergy to meropenem\r\n\r\n          -  Require less than 3 days of meropenem in the hospital\r\n\r\n          -  Require another systemic Beta-lactam antibiotic to treat a concomitant pathogen\r\n\r\n          -  Known fungal or viral infection\r\n\r\n          -  Females in their 2nd or 3rd trimester of pregnancy\r\n\r\n          -  Moderate to severe renal dysfunction, as defined by a creatinine clearance less than\r\n             50 ml/min/1.73m2 (by use of Schwartz method)\r\n\r\n          -  History of solid organ transplantation within previous 6 months\r\n\r\n          -  Active or recent (within 30 days) participation in another antibiotic clinical trial\r\n      ","sponsor":"Joseph Kuti","sponsor_type":"Other","conditions":"Cystic Fibrosis|Pneumonia|Pseudomonas Aeruginosa Infection","interventions":[{"intervention_type":"Drug","name":"Drug: meropenem","description":"meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion."}],"outcomes":[{"outcome_type":"primary","measure":"Population Pharmacokinetics - Total Body Clearance","time_frame":"8 hour dosing interval after 3rd meropenem dose","description":"Based on meropenem concentrations, the pharmacokinetics of the study population will be analyzed to determine each patient's total body clearance."},{"outcome_type":"primary","measure":"Population Pharmacokinetics - Volume of Central Compartment","time_frame":"During 8 hour dosing interval after 3rd meropenem dose","description":"Based on meropenem concentrations, the pharmacokinetics of the study population will be analyzed to determine each patient's volume of the central compartment."},{"outcome_type":"secondary","measure":"Safety","time_frame":"14-21 days","description":"This will be an intention to treat analysis of all 30 participants receiving meropenem as a 3 hour prolonged infusion. Participants will be monitored for any sign of symptom of adverse events throughout the course of the study. An adverse event will be defined as any pathologic or unintended change in the structure (signs), function (symptoms), or chemistry (laboratory values) of the body associated with the use of the study drug."},{"outcome_type":"secondary","measure":"Practicality of 3 Hour Prolonged Infusion","time_frame":"14-21 days","description":"This will be an intention to treat analysis of all 30 participants receiving meropenem as a 3 hour prolonged infusion. The Cystic Fibrosis Questionnaire-Revised (CFQ-R) will be utilized to assess patient or parent assessments of the burden of the prolonged infusion treatment. The CFQ-R will be administered at the beginning of the study and then within 7 days after completion of meropenem therapy."},{"outcome_type":"secondary","measure":"Meropenem Pharmacodynamics","time_frame":"14-21 days","description":"Meropenem exposures defined from the population model for each participant will be analyzed as a function of the isolated pathogens meropenem minimum inhibitory concentration (MIC) to define the exposure of meropenem associated with an absolute and relative percent change in the Forced Expiratory Volume (FEV1)."}]}
{"nct_id":"NCT03115372","start_date":"2012-02-29","phase":"N/A","enrollment":982,"brief_title":"Lay Health Worker Outreach in Increasing Colorectal Cancer Screening in Asian Americans","official_title":"The National Center for Reducing Asian American Cancer Health Disparities Research Project on Lay Health Workers and Asian Americans (AANCART)","primary_completion_date":"2015-07-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-09-01","last_update":"2020-07-29","description":"This randomized clinical trial studies how well a lay health worker outreach works in increasing colorectal cancer screening in Asian Americans. Training community members to educate participants about colorectal cancer and its prevention may improve colorectal cancer screening rates in Asian Americans.","other_id":"11056","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":50,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  LHW: self-identified as Filipino, Hmong, or Korean Americans\r\n\r\n          -  LHW: age 18 or older\r\n\r\n          -  LHW: are fluent in a Filipino language (Tagalog or Ilocano), Hmong, Korean, or English\r\n\r\n          -  LHW: Live in the relevant area and intend to stay there for the next 12 months\r\n\r\n          -  PARTICIPANTS: Self-identified as Filipino, Hmong, or Korean Americans\r\n\r\n          -  PARTICIPANTS: speak a language that the LHW can speak such as Tagalog, Ilocano, Hmong,\r\n             Korean, or English\r\n\r\n          -  PARTICIPANTS: live in relevant area and intend to stay there for at least 12 months\r\n\r\n          -  PARTICIPANTS: Are willing to participate in a study about health behaviors involving\r\n             nutrition or CRC screening\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Personal history of CRC\r\n\r\n          -  Medical problems which may prevent them from attending 2 educational sessions\r\n      ","sponsor":"University of California, San Francisco","sponsor_type":"Other","conditions":"Colorectal Carcinoma|Health Status Unknown|Healthy Subject","interventions":[{"intervention_type":"Other","name":"Other: Educational Intervention","description":"Attend CRC education session"},{"intervention_type":"Other","name":"Other: Educational Intervention","description":"Attend healthy nutrition session"},{"intervention_type":"Other","name":"Other: Informational Intervention","description":"Receive CRC screening brochure"},{"intervention_type":"Other","name":"Other: Survey Administration","description":"Ancillary studies"},{"intervention_type":"Behavioral","name":"Behavioral: Telephone-Based Intervention","description":"Receive telephone reminder about CRC screening"},{"intervention_type":"Behavioral","name":"Behavioral: Telephone-Based Intervention","description":"Receive telephone reminder about healthy nutrition"}],"outcomes":[{"outcome_type":"primary","measure":"Proportion of participants who report ever having had a CRC screening test","time_frame":"Baseline to 6 months","description":"Bivariable and multivariable analyses of the binary outcomes (CRC screening ever, up-to-date, and intention) will be conducted using generalized linear models to evaluate the efficacy of the intervention. A linear model with identity link function will be used with group (intervention or control), time (pre- or post-), and group-by-time interaction to test for a difference in the change from pre- to post-intervention between the 2 groups, thus measuring the efficacy of the intervention."},{"outcome_type":"secondary","measure":"Proportion of participants who are up-to-date for CRC screening","time_frame":"At 6 months","description":"Bivariable and multivariable analyses of the binary outcomes (CRC screening ever, up-to-date, and intention) will be conducted using generalized linear models to evaluate the efficacy of the intervention."},{"outcome_type":"secondary","measure":"Proportion of participants who intend to obtain CRC screening in the next 6 months","time_frame":"At 6 months","description":"Bivariable and multivariable analyses of the binary outcomes (CRC screening ever, up-to-date, and intention) will be conducted using generalized linear models to evaluate the efficacy of the intervention."}]}
{"nct_id":"NCT01603121","start_date":"2012-02-29","phase":"Phase 1/Phase 2","enrollment":1,"brief_title":"Lisofylline as Continuous Subcutaneous and Intravenous Administration in Subjects With Type 1 Diabetes Mellitus","official_title":"A Safety, Tolerability and Bioavailability Study of Lisofylline After Continuous Subcutaneous (12 mg/kg) and Intravenous (9 mg/kg) Administration in Subjects With Type 1 Diabetes Mellitus","primary_completion_date":"2013-05-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2013-05-31","last_update":"2016-08-18","description":"The primary goal of the study is to investigate the safety and tolerability of the investigational drug lisofylline, when administered under the skin or in the vein, in people with type 1 diabetes. A second aim is to determine how much drug is available in the blood after injection under the skin, compared to injection in the vein.","other_id":"DL-001","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female adults between the ages of 18 and 45 years of age\r\n\r\n          -  Ability to understand and provide written informed consent\r\n\r\n          -  Ability to complete the study in compliance with the protocol\r\n\r\n          -  If female, subjects must be non-pregnant and non-lactating, and willing to use\r\n             appropriate and adequate contraception during the study\r\n\r\n          -  If male, subjects must be willing to use effective birth control during the study\r\n\r\n          -  Weight at least 50 kgs (110 lbs)\r\n\r\n          -  Body mass index between 18.5 and 30 kg/m2\r\n\r\n          -  QTc < 450 msec at screening\r\n\r\n          -  Clinical diagnosis of type 1 diabetes at least 2 years prior to screening\r\n\r\n          -  Treatment with insulin for at least 1 year and on a stable dose for at least 3 months\r\n             prior to screening (dose must be < 0.8 units/kg/day)\r\n\r\n          -  Subjects must self-monitor blood glucose levels at least daily\r\n\r\n          -  HbA1c 6-9%\r\n\r\n          -  Serum c-peptide level < 0.6 ng/mL\r\n\r\n          -  Serum creatinine < 1.5 mg/dL for males and < 1.4 mg/dL for females\r\n\r\n          -  Negative hepatitis B, hepatitis C and HIV testing at screening or within 3 months of\r\n             screening\r\n\r\n          -  Subjects must be free from clinically significant abnormal findings at the time of\r\n             screening (to include abnormalities on examination, medical history,\r\n             electrocardiogram, clinical laboratory testing); to be determined by principal\r\n             investigator\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subjects with significant stomach, liver, kidney or heart disease, including high\r\n             blood pressure, stroke or other blood vessel disease. Significant eye problems due to\r\n             diabetes, diabetic nerve disease, or non-healed diabetic foot ulcers\r\n\r\n          -  Personal or family history of long QTc syndrome\r\n\r\n          -  History of clinically significant changes in orthostatic blood pressure\r\n\r\n          -  Clinically significant changes in orthostatic blood pressure at screening\r\n\r\n          -  History of peptic ulcer disease and/or gastrointestinal bleeding/perforation\r\n\r\n          -  History or presence of proliferative retinopathy, severe non-proliferative\r\n             retinopathy, macular edema or presence of untreated diabetic eye disease\r\n\r\n          -  History of severe peripheral or autonomic neuropathy in the opinion of the study\r\n             physician\r\n\r\n          -  History of hypoglycemia unawareness, and/or episodes of severe hypoglycemia within 60\r\n             days of screening\r\n\r\n          -  Diagnosis of type 2 diabetes, based upon subject report\r\n\r\n          -  Use of oral antihyperglycemic medications, pentoxyifylline, and/or theophylline\r\n\r\n          -  Use of any drug therapy that directly affects gastrointestinal motility\r\n\r\n          -  History of any significant drug allergy\r\n\r\n          -  History of difficulty with phlebotomy\r\n\r\n          -  Use of any recreational drugs within the past year or a previous history of drug or\r\n             alcohol abuse\r\n\r\n          -  Positive results from a screen for alcohol or substances of abuse at screening or upon\r\n             admission to the study site\r\n\r\n          -  Current smoker or user of any tobacco products\r\n\r\n          -  Use of prescription medications is acceptable at the Principal Investigator's\r\n             discretion if they have been part of a stable drug regimen documented for the last 60\r\n             days. Drug therapy should be held the morning of Day 1 and Day 7 at the Principal\r\n             Investigator's discretion\r\n\r\n          -  use of any over-the-counter drugs or herbal preparations within 72 hours prior to\r\n             receiving study drug\r\n\r\n          -  Consumption of any caffeine-containing foods or beverages within 24 hours prior to\r\n             receiving study drug\r\n\r\n          -  Consumption of alcohol within 24 hours prior to admission to the study site\r\n\r\n          -  Consumption of any grapefruit or grapefruit-containing juices within 72 hours prior to\r\n             receiving study drug\r\n\r\n          -  Use of an investigational drug or product, or participation in a drug research study\r\n             within 30 days prior to receiving drug\r\n\r\n          -  Prior exposure to lisofylline\r\n\r\n          -  Donation of blood (1 pint or more) within 30 days or plasma within 7 days of receiving\r\n             study drug\r\n\r\n          -  Any condition which in the opinion of the study investigator would interfere with the\r\n             participant's ability to provide informed consent, comply with study instructions,\r\n             possibly confound interpretation of study results, or endanger the participant if he\r\n             or she took part in the trial\r\n      ","sponsor":"Eastern Virginia Medical School","sponsor_type":"Other","conditions":"Type 1 Diabetes Mellitus","interventions":[{"intervention_type":"Drug","name":"Drug: Lisofylline","description":"Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."}],"outcomes":[{"outcome_type":"primary","measure":"Safety and Tolerability of Study Drug","time_frame":"1 month","description":"Subjects will be monitored for adverse events both during and after the study drug infusion and will undergo physical examinations, electrocardiograms and clinical safety laboratory tests.\r\nStudy staff will contact subjects within 5 days after each dosing period and approximately 30 days after the 2nd dosing period, to review laboratory results and to ask the subject about any changes in health that they have experienced. Should the subject require an in-person evaluation, this will be arranged with the principal or sub-investigator promptly."},{"outcome_type":"secondary","measure":"Study Drug Bioavailability After Subcutaneous and Intravenous Infusion","time_frame":"24 hours","description":"Blood will be collected for determination of lisofylline concentrations at various predetermined time points during the infusions, and 10 and 24 hours following infusion completion. This will help to determine if subcutaneous infusion over 10 hours results in similar lisofylline plasma concentrations as with intravenous infusion."},{"outcome_type":"secondary","measure":"Evaluation of Early Efficacy of Study Drug","time_frame":"24 hours","description":"Blood draws will be performed at predetermined time points during and after the infusions in order to measure serum cytokine and chemokine concentrations, as well as to measure plasma STAT 4 and phosphorylated STAT 4 (markers of lisofylline efficacy)."}]}
{"nct_id":"NCT02829645","start_date":"2012-02-29","phase":"N/A","enrollment":370,"brief_title":"Evaluation of the Clinical, Neuropsychological and Psychosocial Situation of Patient With Eating Disorders.","official_title":"Evaluation of the Clinical, Neuropsychological and Psychosocial Situation of Patient With Eating Disorders.","primary_completion_date":"2014-10-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2017-10-31","last_update":"2016-07-12","description":"Eating disorders (ED) are serious mental illnesses with an excess mortality and many affects in the quality of life of patients and thier relatives. Management of ED is very difficult : the prognosis remains relatively poor both in terms of remission rate and quality of life. In this context, the contribution of new strategies for pathophysiological exploration and the development of therapeutic options are crucial. In this project the investigators aim to constitute un cohort of patients from a day unit specialized in the management of ED. A prospective follow-up will be offered to patients to assess their clinical and psycho-social evolution. The overall objective is to identify which factors are prognostic of clinical improvement of the ED. We also want to better characterize patients that will migrate from diagnosis to another.","other_id":"UF 8854","allocation":"N/A","intervention_model":"Single Group Assignment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":15,"maximum_age":65,"population":"","criteria":"\n        Inclusion criteria:\r\n\r\n          -  respond to DSM 4 criteria for ED\r\n\r\n          -  Age 15 to 65 years\r\n\r\n          -  Signing an informed consent.\r\n\r\n          -  Affiliated to a social security scheme or being the beneficiary of such a scheme.\r\n\r\n        Exclusion criteria:\r\n\r\n          -  Manifest inability of the subject to understand / perform clinical and\r\n             neuropsychological evaluations and tasks\r\n\r\n          -  Major protected by law (guardianship)\r\n\r\n          -  Privation of liberty by judicial or administrative decision\r\n\r\n          -  Pregnant or lactating women\r\n      ","sponsor":"University Hospital, Montpellier","sponsor_type":"Other","conditions":"Eating Disorders","interventions":[{"intervention_type":"Other","name":"Other: Clinical assessment","description":"Clinical assessment with questionnaires"}],"outcomes":[{"outcome_type":"primary","measure":"Frequency of remission rates","time_frame":"At the inclusion and at 12, 24 and 36 months","description":"study of remission rates frequency at 12 months depending on the Brixton score assessed at baseline (assessment of cognitive flexibility). Remission is defined as disappearance of ED Diagnostic and Statistical Manual (DSM) criteria."},{"outcome_type":"secondary","measure":"score to another neuropsychological test (Iowa gambling task (IGT)","time_frame":"At the inclusion and at 12, 24 and 36 months","description":"Study of remission rates frequency at 12 months depending on the IGT score (decision making) assessed at baseline"},{"outcome_type":"secondary","measure":"scores to another other neuropsychological test : Rey-Osterrieth complex figure","time_frame":"At the inclusion and at 12, 24 and 36 months","description":"Study of remission rates frequency at 12 months depending on the Rey figure assessed at baseline"},{"outcome_type":"secondary","measure":"scores to another neuropsychological test : D2 test of attention","time_frame":"At the inclusion and at 12, 24 and 36 months","description":"Study of remission rates frequency at 12 months depending on the D2 test (attention) assessed at baseline"}]}
{"nct_id":"NCT01427257","start_date":"2012-02-29","phase":"Phase 1","enrollment":10,"brief_title":"Pharmacokinetic Profile of Two Formulations of PB1023 Following Single Subcutaneous Injection in Subjects With Type 2 Diabetes Mellitus","official_title":"Phase 1 Open-Label Two-Way Cross Over Study to Assess the Pharmacokinetic Profile of Two Formulations of PB1023 Injection Following a Single Dose Administered By Subcutaneous Injection in Adult Subjects With Type 2 Diabetes Mellitus (T2DM)","primary_completion_date":"2012-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-09-30","last_update":"2012-10-01","description":"Primary objective: To compare the pharmacokinetic profile of PB1023 after a single dose administered by subcutaneous injection of two formulations (concentrations). Secondary objectives: To evaluate the safety and tolerability of two formulations of PB1023 Injection administered as a subcutaneous injection in adult subjects with T2DM. To evaluate the impact on the pharmacokinetic profile of PB1023 after a single 90 mg dose of formulation B (100 mg/mL) administered cold at 2 to 8C by subcutaneous injection.","other_id":"PB1023-PT-CL-0002","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Willing and able to sign a written informed consent and follow all study related\r\n             procedures.\r\n\r\n          -  Males or post menopausal or surgically sterile females age 18 - 75 years of age\r\n             inclusive.\r\n\r\n          -  Diagnosed with T2DM for  6 months.\r\n\r\n          -  HbA1c of  6.0% if diet and exercise controlled, or 5.8% if taking one or more\r\n             glucose lowering agents\r\n\r\n          -  Weight  45 kg and BMI  40 kg/m2\r\n\r\n          -  In otherwise stable health except for T2DM (no clinically significant laboratory\r\n             abnormalities, vital signs, ECG findings or clinically significant underlying disease\r\n             that would put the subject at risk for participation in the study).\r\n\r\n          -  Receiving stable doses of concomitant medications for 30 days prior to dosing.\r\n\r\n          -  Criteria for Participation in Period 3 only: Received PB1023 Injection at 50 mg/mL and\r\n             100 mg/mL during Period 1 or 2 of the study and had adequate pharmacokinetic samples\r\n             collected for evaluation of their pharmacokinetic profile.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Currently taking Byetta or Victoza.\r\n\r\n          -  Previously received PB1023 Injection other than under this study protocol.\r\n\r\n          -  Known allergy or serious adverse effect to an approved or investigational GLP-1\r\n             receptor analog/agonist.\r\n\r\n          -  Unstable cardiovascular disease defined as:\r\n\r\n               -  History of stroke, transient ischemic attack, or myocardial infarction within 6\r\n                  months prior to the Screening visit.\r\n\r\n               -  Screening (duplicate supine reading) BP  160 mmHg (systolic) or  100 mmHg\r\n                  (diastolic).\r\n\r\n               -  Mean triplicate 12-lead ECG demonstrating QT interval (corrected) (QTc) > 450\r\n                  msec in males and > 470 msec in females at the Screening visit, or a history or\r\n                  evidence of long QT syndrome.\r\n\r\n          -  Based on contraindications/warnings identified with other GLP-1 receptor agonists,\r\n             subjects will be excluded if they have:\r\n\r\n               -  History, symptoms or signs of pancreatitis or severe gastrointestinal disease\r\n                  (i.e., gastroparesis)\r\n\r\n               -  Personal or family history of medullary thyroid tumors or history of Multiple\r\n                  Endocrine Neoplasia Syndrome Type 2. Note: Abnormal serum calcitonin at screening\r\n                  will exclude the subject from participation.\r\n\r\n          -  Clinically significant renal and/or hepatic dysfunction at screening as indicated by\r\n             the following:\r\n\r\n               -  eGFR as calculated by MDRD of < 60 mL/min\r\n\r\n               -  Urine dipstick protein > 2+ (100 mg/dL) or urine protein 2+ and a Urine\r\n                  Protein/Creatinine ratio > 1.0 (> 1000 mg/g)\r\n\r\n               -  Alanine aminotransferase (ALT) > 2 x ULN\r\n\r\n               -  Aspartate aminotransferase (AST) > 2 x ULN\r\n\r\n               -  Serum bilirubin  1.6 mg/dL\r\n\r\n          -  Pregnant or lactating females\r\n\r\n          -  Known history of or active alcohol or drug abuse within 12 months prior to Screening\r\n             or positive alcohol and/or drug screen.\r\n\r\n          -  Positive for Human Immunodeficiency Virus (HIV) antibodies, Hepatitis B surface\r\n             antigen (HBsAg) or Hepatitis C Virus (HCV) antibodies.\r\n\r\n          -  Participating in any other study and have received any other investigational drug or\r\n             device within 30 days prior to the Screening visit or are taking part in a non-drug\r\n             study which in the opinion of the Investigator would interfere with the outcome of the\r\n             study.\r\n\r\n          -  Other medical (i.e., acute or chronic illness) or psychiatric condition which in the\r\n             opinion of the Investigator would place the subject at increased risk, confound the\r\n             primary study endpoint, or would preclude obtaining voluntary consent.\r\n      ","sponsor":"PhaseBio Pharmaceuticals Inc.","sponsor_type":"Industry","conditions":"Diabetes Mellitus, Type 2","interventions":[{"intervention_type":"Drug","name":"Drug: Single Dose PB1023","description":"Single Dose PB1023 Formulation A"},{"intervention_type":"Drug","name":"Drug: Single Dose PB1023","description":"Single Dose PB1023 Formulation B"},{"intervention_type":"Drug","name":"Drug: Single Dose PB1023","description":"Single Dose PB1023 Formulation B"}],"outcomes":[{"outcome_type":"primary","measure":"Pharmacokinetics","time_frame":"For each dosing period: Pre-dose, 1, 4, 8, 12 hours, 1, 2, 3, 4, 7 and 10 days post-dose","description":"The pharmacokinetic profile of two formulations of PB1023 will be compared. The following parameters will be evaluated: t1/2, AUC(inf), AUC(0-t), Tmax, Cmax, Elimination Rate Constant, Clearance and Distribution."},{"outcome_type":"secondary","measure":"Safety/Tolerability","time_frame":"42 Days","description":"Safety will be evaluated by analyses of incidence of adverse events of interest (possibly related to the class of drug) and other adverse events. Vital signs, ECGs and safety laboratory parameters will also be presented."}]}
{"nct_id":"NCT01501747","start_date":"2012-02-29","phase":"N/A","enrollment":162,"brief_title":"The Placebo Effect May Involve Modulating Drug Bioavailability","official_title":"The Placebo Effect May Involve Modulating Drug Bioavailability","primary_completion_date":"2013-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-02-28","last_update":"2013-04-09","description":"The total effect of a medication is the sum of its drug effect, placebo effect (meaning response of placebo), and their interaction. Current interpretation of clinical trials (the gold standard of evidence-based-medicine) assumes no interaction, and the mechanism(s) underlying such interaction have not been fully explored. One possibility is that the placebo effect may modulate drug bioavailability. Using caffeine as a model drug, we have recently shown that the placebo effect of caffeine ingestion prolongs caffeine half life. Due to the novelty of this finding and its important clinical practice and clinical research implications, it needs to be confirmed in another set of subjects and extended to additional drugs. The results of the study are expected to further our understanding of the mechanism of action of a widely used medical intervention, i.e., placebo. The results will be important for both clinical practice and clinical research.","other_id":"RAC2101105","allocation":"Randomized","intervention_model":"Crossover Assignment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Having no evidence of clinically important deviation from normal health as indicated\r\n             by medical history, vital signs, and clinical laboratory tests.\r\n\r\n          -  Acceptance to abstain from taking any medication other than birth control pills\r\n             (including over-the-counter drugs) for at least 1 week prior to, and during the study;\r\n             and from smoking and taking alcohol or caffeine or related xanthenes-containing\r\n             beverages or food for 48 hours before and throughout each study period.\r\n\r\n          -  Having good peripheral venous access.\r\n\r\n          -  For the caffeine study, habitual daily caffeine intake should be 100-300 mg.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Women should be non-pregnant and non-lactating. For menstruating women, the study will\r\n             be conducted 5 to 19 days after the last menstrual period and a urine pregnancy test\r\n             will be performed.\r\n\r\n          -  Should not have history of hypersensitivity to the drug to be tested or to its related\r\n             compounds.\r\n\r\n          -  Body Mass Index (BMI) should be less than 35 kg/m2.\r\n      ","sponsor":"King Faisal Specialist Hospital & Research Center","sponsor_type":"Other","conditions":"Placebo Effect|Drug Half Life|Pharmacokinetics","interventions":[{"intervention_type":"Drug","name":"Drug: Caffeine, paracetamol, cephalexin, or ibuprofen","description":"The study has 4 sub-parts (one for each of 4 drugs), each sub-part has a crossover design. In this arm, the volunteer will be given one oral dose of 300 mg caffeine, 500 mg paracetamol, 500 mg cephalexin, or 400 mg ibuprofen and will be told that they are receiving the active drug."},{"intervention_type":"Drug","name":"Drug: Placebo (caffeine, paracetamol, cephalexin, or ibuprofen)","description":"The study has 4 sub-parts (one for each of 4 drugs), each sub-part has a crossover design. In this arm, the volunteer will be given one oral dose of 300 mg caffeine, 500 mg paracetamol, 500 mg cephalexin, or 400 mg ibuprofen and will be told that they are receiving a placebo."}],"outcomes":[{"outcome_type":"primary","measure":"Plasma half life","time_frame":"24 hours","description":"The study has 4 sub-parts (one for eah of 4 drugs), each sub-part has a crossover design. The time frame to measure the outcome depends on the drug studied. For caffeine it is 24 hours, for paracetamol, it is 14 hours, for cephalexin, it is 6 hours, and for ibuprofen, it is 10 hours."},{"outcome_type":"secondary","measure":"Area under the curve","time_frame":"24 hours","description":"The study has 4 sub-parts (one for eah of 4 drugs), each sub-part has a crossover design. The time frame to measure the outcome depends on the drug studied. For caffeine it is 24 hours, for paracetamol, it is 14 hours, for cephalexin, it is 6 hours, and for ibuprofen, it is 10 hours."},{"outcome_type":"secondary","measure":"Tmax","time_frame":"24 hours","description":"The study has 4 sub-parts (one for eah of 4 drugs), each sub-part has a crossover design. The time frame to measure the outcome depends on the drug studied. For caffeine it is 24 hours, for paracetamol, it is 14 hours, for cephalexin, it is 6 hours, and for ibuprofen, it is 10 hours."},{"outcome_type":"secondary","measure":"Cmax","time_frame":"24 hours","description":"The study has 4 sub-parts (one for eah of 4 drugs), each sub-part has a crossover design. The time frame to measure the outcome depends on the drug studied. For caffeine it is 24 hours, for paracetamol, it is 14 hours, for cephalexin, it is 6 hours, and for ibuprofen, it is 10 hours."}]}
{"nct_id":"NCT01565460","start_date":"2012-02-29","enrollment":200,"brief_title":"Bile and Bile Duct/Pancreatic Duct Brushings Database for Patients With Pancreato-biliary Stricture","official_title":"Bile and Bile Duct/Pancreatic Duct Brushings Database for Patients With Pancreato-biliary Stricture","primary_completion_date":"2016-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2016-12-31","last_update":"2017-03-30","description":"The purpose of this study is to create a long-term storage of bile and brushings of pancreato-biliary duct in patients diagnosed with pancreato-biliary stricture for future research. Recently, a lot of research has been done to test for certain markers in the bile and brushings to detect cancer in a stricture. The samples will be used to measure biomarkers (proteins) in biliary diseases.","other_id":"11-976","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":19,"population":"All patients with pancreatic or biliary duct stricture who present for evaluation and\r\n        intervention of their stricture","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Any patient diagnosed with pancreato-biliary stricture.\r\n\r\n          -  Age >18 years\r\n\r\n          -  Ability to provide an informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with altered mental status, who will not be able to provide an informed\r\n             consent\r\n\r\n          -  Pregnant women\r\n      ","sponsor":"The Cleveland Clinic","sponsor_type":"Other","conditions":"Pancreatic Duct Strictures|Biliary Duct Strictures","interventions":[{"intervention_type":"Other","name":"Other: Sample Collection","description":"Sample Collection: bile and pancreatic duct brushings and fluid samples will be obtained from the pancreatic stricture during endoscopic retrograde cholangiopancreatic procedure."}],"outcomes":{}}
{"nct_id":"NCT01602822","start_date":"2012-02-29","phase":"Phase 4","enrollment":11,"brief_title":"Safety and Acceptability Study of Non-occupational Prophylaxis (PEP) Following Potential Exposure to HIV","official_title":"A Phase IV Open-label Evaluation of Safety, Tolerability and Patient Acceptance of Atazanavir Boosted With Ritonavir Combined With a Fixed-dose Formulation of Tenofovir DF and Emtricitabine for Non-occupational Prophylaxis Following Potential Exposure to HIV-1","primary_completion_date":"2012-05-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2012-05-31","last_update":"2013-03-07","description":"This study will evaluate how safe and tolerable a combination of taking three-drugs will be for the purpose of preventing HIV transmission after a high-risk sexual contact exposure in HIV uninfected adults.","other_id":"BMS PEP","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age of 18 at time of first visit.\r\n\r\n          2. HIV uninfected on the basis of a negative HIV Rapid Test\r\n\r\n          3. Possible non-occupational exposure to HIV-1, recent enough to permit receiving the\r\n             first dose of study medication within 72 hours from the end of the exposure.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Women who are actively trying to become pregnant.\r\n\r\n          2. Pregnancy and/or Breastfeeding.\r\n\r\n          3. Known self report of Chronic Hepatitis B infection or prior antiretroviral therapy for\r\n             hepatitis B.\r\n\r\n          4. Known intolerance or allergy to study drugs.\r\n      ","sponsor":"Kenneth H. Mayer, MD","sponsor_type":"Other","conditions":"HIV","interventions":[{"intervention_type":"Drug","name":"Drug: 3 drug regimen: Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir","description":"TDF 300mg and FTC 200mg fixed-dose combination tablet (TDF/FTC) once daily, and atazanavir, one 300mg tablet and one 100 mg ritonavir given once daily"},{"intervention_type":"Drug","name":"Drug: Ritonavir, Atazanavir, Truvada"}],"outcomes":[{"outcome_type":"primary","measure":"Safety of regimen","time_frame":"Visit 3- Day 30","description":"Safety and tolerability of the regimen will be assessed by the percentage of participants who at or by visit 3: (1) report moderate-to-severe symptoms on the symptom-directed physical exam, (2) report adverse or serious adverse events that are considered related to the use of the drug regimen, and/or (3) have unsafe biological test results as part of the laboratory screen for safety levels (e.g., CBC, Creatinine, etc.)."},{"outcome_type":"primary","measure":"Tolerability of regimen","time_frame":"Visit 3- Day 30","description":"Safety and tolerability of the regimen will be assessed by the percentage of participants who at or by visit 3: (1) report moderate-to-severe symptoms on the symptom-directed physical exam, (2) report adverse or serious adverse events that are considered related to the use of the drug regimen, and/or (3) have unsafe biological test results as part of the laboratory screen for safety levels (e.g., CBC, Creatinine, etc.)."},{"outcome_type":"secondary","measure":"Awareness of NPEP","time_frame":"Visit 5- Day 170","description":"First we will determine how many participants had initially heard of NPEP prior to the incident exposure, as well as how many participants had ever taken NPEP before. Next, using the McNemar's Test, we will assess pre- and post-test attitudes about NPEP by comparing the proportion of participants who endorsed any level of disagreement with those who endorsed any level of agreement among the seven statements on PEP attitudes from baseline (visit 0) to the 6-month follow-up appointment (visit 5)."},{"outcome_type":"secondary","measure":"Compare adherence rates","time_frame":"Visit 3- Day 30","description":"Adherence to the regimen will be assessed by whether the regimen was completed as prescribed or not. Additionally, if the regimen was not completed as prescribed, we will calculate the proportion adherence (i.e., the number of pills taken compared to the number of pills in the regimen). χ2 tests will be used to assess differences in the proportion of both completion and adherence between participants in the current study and participants in previous studies of NPEP at Fenway Health (historical controls)"}]}
{"nct_id":"NCT01663883","start_date":"2012-02-29","phase":"N/A","enrollment":40,"brief_title":"Optic Nerve Head Autoregulation During Changes in Arterial Blood Pressure","primary_completion_date":"2012-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-08-31","last_update":"2012-08-13","description":"Constant despite changes in perfusion pressure. It is observed in many vascular beds of the human body to prevent that variations in perfusion pressure are directly transmitted into changes in blood flow. This is necessary to prevent ischemia and/or hypoxia during decreased blood flow and bleeding or increased capillary pressure during increased blood flow. In the eye, several studies have reported that retinal blood flow is autoregulated over a wide range of ocular perfusion pressures. Unfortunately only few data are available for the optic nerve head. To gain data about autoregulation is of special importance given that several important ocular diseases such as glaucoma and age-related macular degeneration are associated with impaired autoregulation. In humans most data were collected using laser Doppler flowmetry. The present study aims to investigate the phenomenon of transient reduction in blood flow and to gain insight in the regulatory mechanisms of optic nerve head blood flow during isometric exercise.","other_id":"OPHT-210911","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":35,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Men and women aged between 18 and 35 years, nonsmokers\r\n\r\n          -  Normal findings in the medical history and physical examination unless the\r\n             investigator considers an abnormality to be clinically irrelevant\r\n\r\n          -  Normal ophthalmic findings, ametropia less than 3 diopters\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Regular use of medication, abuse of alcoholic beverages, participation in a clinical\r\n             trial in the 3 weeks preceding the study\r\n\r\n          -  Treatment in the previous 3 weeks with any drug (except oral contraceptives)\r\n\r\n          -  Symptoms of a clinically relevant illness in the 3 weeks before the first study day\r\n\r\n          -  Blood donation during the previous 3 weeks\r\n      ","sponsor":"Medical University of Vienna","sponsor_type":"Other","conditions":"Decreased Vascular Flow","interventions":[{"intervention_type":"Other","name":"Other: Isometric exercise","description":"use of a handgrip for 3x2 minutes"}],"outcomes":[{"outcome_type":"secondary","measure":"Pulse rate","time_frame":"14 minutes"},{"outcome_type":"primary","measure":"Optic nerve head blood flow","time_frame":"12 minutes"},{"outcome_type":"secondary","measure":"Systolic/diastolic blood pressure","time_frame":"14 minutes"},{"outcome_type":"secondary","measure":"Intraocular pressure","time_frame":"at baseline and minute 13"}]}
{"nct_id":"NCT00934700","start_date":"2012-02-29","phase":"Phase 1/Phase 2","enrollment":92,"brief_title":"Neuroprotective Effects of Hypothermia Combined With Inhaled Xenon Following Perinatal Asphyxia","official_title":"Neuroprotective Effects of Hypothermia Combined With Inhaled Xenon Following Perinatal Asphyxia","primary_completion_date":"2014-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-09-30","last_update":"2014-10-28","description":"This is a randomised controlled trial in newborn infants with perinatal asphyxial encephalopathy assessing whether a combination of hypothermia and inhaled xenon preserve cerebral metabolism and structure.","other_id":"prot-002-2009","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","maximum_age":12,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Infants will be eligible for enrolment into the trial if each of the following criteria is\r\n        fulfilled:\r\n\r\n          -  Infants 36 to 43 weeks gestation with at least one of the following:\r\n\r\n               -  Apgar score of <5 at 10 minutes after birth;\r\n\r\n               -  Continued need for resuscitation, including endotracheal or mask ventilation, at\r\n                  10 minutes after birth;\r\n\r\n               -  Acidosis defined as pH <7.00 and/or base deficit >15 mmol/L in umbilical cord\r\n                  blood sample or any blood sample within 60 minutes of birth (arterial or venous\r\n                  blood).\r\n\r\n          -  Moderate to severe encephalopathy consisting of altered state of consciousness\r\n             (reduced or absent response to stimulation) and hypotonia, and abnormal primitive\r\n             reflexes (weak or absent suck or Moro response). Clinical severity of HIE will be\r\n             assessed by Thompson encephalopathy score, and modified Sarnat score.\r\n\r\n          -  At least 30 minutes duration of amplitude integrated EEG (aEEG) recording that shows\r\n             moderately abnormal or suppressed background aEEG activity or seizures\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  If treatment with hypothermia is delayed beyond 6 hours, or infants are expected to be\r\n             >12 hours of age at the time of randomisation; Infants with ventilatory oxygen\r\n             requirement > 70%; Attending clinician considers infant not suitable to participate\r\n             because of other serious congenital abnormalities, or the infant's condition appears\r\n             terminal.\r\n      ","sponsor":"Imperial College London","sponsor_type":"Other","conditions":"Hypoxic Ischaemic Encephalopathy","interventions":[{"intervention_type":"Other","name":"Other: Xenon gas","description":"30% Xenon gas inhaled for 24 hours"}],"outcomes":[{"outcome_type":"primary","measure":"The primary outcome will be: reduction in Lac/NAA ratio on magnetic resonance spectroscopy or preserved fractional anisotropy measured on diffusion weighted magnetic resonance imaging","time_frame":"10 days"},{"outcome_type":"secondary","measure":"Clinical outcomes at hospital discharge","time_frame":"At discharge from hospital"}]}
{"nct_id":"NCT01503294","start_date":"2012-02-29","enrollment":60,"brief_title":"Comparison of Temporal to Pulmonary Artery Temperature Measurement in Patients With Fever","official_title":"Comparison of Temporal to Pulmonary Artery Temperature Measurement in Patients With Fever","primary_completion_date":"2014-03-31","study_type":"Observational","rec_status":"Completed","completion_date":"2014-06-30","last_update":"2014-06-30","description":"Assessment and evaluation of body temperature is an important sign of health and disease. Inferior thermometry increases the risk of morbidity and mortality, and increases health care cost by delaying the diagnosis and treatment of fever-related disease. The gold standard for measuring core body temperature is the pulmonary artery thermistor (PAT). The measurement of the PAT requires the insertion of the invasive pulmonary artery catheter, a high risk procedure. An innovative thermometry technology, the temporal artery thermometer (TAT), has been introduced into the clinical arena as a potential non-invasive proxy for the PAT. The TAT reduces the risk and cost of pulmonary artery catheter insertion by non-invasively measuring core blood temperature by measuring temperature over the skin of the temporal artery. Research to demonstrate the precision and accuracy of the TAT in normothermic patients has been published, but little to no data is available in those with temperatures greater than 100.4oF. The purpose of this study is to measure the precision and accuracy of 2standard of care temperature methods: the thermistor from the PAT, considered the gold standard, and the TAT as measured in those patients with a PAT temperature greater than 100.4oF.","other_id":"TAT-1","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":90,"population":"ICU patients","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Pulmonary artery catheter in place for a clinical indication,\r\n\r\n          2. fever > 100.4oF\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. significant carotid or cerebrovascular disease,\r\n\r\n          2. PA catheter is not in proper position as confirmed by chest x-ray\r\n      ","sponsor":"Massachusetts General Hospital","sponsor_type":"Other","conditions":"Fever","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"accuracy and precision of the TAT as compared to the PAT","time_frame":"1 minute","description":"Recorded temperature from the PAT and then collected TAT temperature."}]}
{"nct_id":"NCT01697488","start_date":"2012-02-02","enrollment":1090,"brief_title":"An Observational Study of Avastin (Bevacizumab) in Combination With Carboplatin/Paclitaxel in First Line in Patients With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (OTILIA)","official_title":"Non-interventional Surveillance Study (NIS) on First-line (FL) Bevacizumab (Avastin) in Combination With Carboplatin/Paclitaxel in Patients With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer","primary_completion_date":"2019-09-27","study_type":"Observational","rec_status":"Completed","completion_date":"2019-09-27","last_update":"2019-10-08","description":"This observational study will evaluate the safety, efficacy, quality of life and predictive/selection factors for Avastin (bevacizumab) in combination with carboplatin/paclitaxel in first line in patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer in clinical practice. Data of eligible patients will be collected during up to 15 months of treatment and 12 months of follow-up. A second recruitment phase has been opened to focus on patients >/= 70 years.","other_id":"ML27765","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"Patients with newly diagnosed advanced epithelial ovarian, fallopian tube or primary\r\n        peritoneal cancer with indication for first-line carboplatin/paclitaxel chemotherapy in\r\n        combination with Avastin. In the second study phase recruitment focusses on patients >/= 70\r\n        years.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Study phase 1: Patients aged >/= 18 years\r\n\r\n          -  Study phase 2: Patients aged >/= 70 years\r\n\r\n          -  Newly diagnosed advanced epithelial ovarian cancer, fallopian tube carcinoma or\r\n             primary peritoneal cancer with indication for a first-line carboplatin/paclitaxel\r\n             chemotherapy in combination with Avastin\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Contraindications to Avastin according to Summary of Product Characteristics\r\n      ","sponsor":"Hoffmann-La Roche","sponsor_type":"Industry","conditions":"Peritoneal Neoplasms","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Efficacy: Progression-free survival","time_frame":"up to approximately 27 months"},{"outcome_type":"primary","measure":"Safety: Incidence of adverse events","time_frame":"approximately 5 years"},{"outcome_type":"secondary","measure":"Quality of life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30/QLQ-OV28 questionnaires","time_frame":"up to approximately 27 months"},{"outcome_type":"secondary","measure":"Selection criteria for first-line treatment with Avastin and carboplatin/paclitaxel: clinical/demographic patient characteristics","time_frame":"approximately 5 years"},{"outcome_type":"secondary","measure":"Treatment discontinuations/modifications","time_frame":"approximately 5 years"},{"outcome_type":"secondary","measure":"Treatment duration","time_frame":"approximately 5 years"}]}
{"nct_id":"NCT01499784","start_date":"2012-01-31","phase":"N/A","enrollment":5,"brief_title":"Urinary Incontinence in an Inpatient Rehab Unit","official_title":"Can Urinary Incontinence be Treated in an In-patient Rehabilitation Setting?","primary_completion_date":"2013-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-12-31","last_update":"2015-10-27","description":"Urinary incontinence (UI) is a very common condition in women, with estimates of prevalence varying from 10% to 40% in most studies and showing a gradual increase with age. UI is a serious medical problem that can lead to urinary tract infections, low back pain, respiratory disorders, pressure sores, and an increased risk of falls. It also leads to social problems, creating embarrassment and negative self-perception for those who suffer from it. Women with urinary incontinence find themselves isolated and relatively inactive. A wide range of treatments has been used in the management of women's UI, including conservative interventions, pharmaceutical intervention, and surgery. A Cochrane Review from 2008 stated that pelvic floor muscle training (PFMT) is better than no treatment for UI and supports the recommendation that PFMT should be the first treatment line in conservative management programs for women with UI. Recently, there have been a few articles published that looked at the effectiveness of treating UI in a group-like setting with both behavioral modifications and pelvic floor exercises. One study was able to prove that group training of behavioral modification helped to reduce UI severity, increase pelvic floor strength, and reduce voiding frequency when compared to a control group. All of the studies cited were performed in community-dwelling persons with out-patient services and interventions. Dr. Fitzgerald and her colleagues from The Rehabilitation Institute of Chicago (RIC) were able to confirm in a poster presentation that many patients admitted to an inpatient rehabilitation facility do have UI. In 2005, out of 403,697 Medicare beneficiaries admitted to a rehab hospital, 24% were incontinent. These studies were able to illustrate that UI affects all diagnoses. UI was shown to make a significant contribution to patient outcomes independent of functional status at admission. It is also a large determinant of discharge destination. In the United Kingdom in 2004, 62% of incontinent stroke patients were discharged to a sub acute home with only 5% placement for continent stroke survivors. Another study determined that urinary incontinence after having a stroke predicted a higher likelihood of an adverse outcome when controlled for age, type of stroke, and length of hospital stay. May, et. al., was able to state while in an acute rehab setting that patients with spinal cord injuries ranked bowel and bladder care, along with skin care, as most important in an education class with 12 different topics. This shows that patients find bladder function a large priority in their care, even in an in-patient setting. In the poster presentation mentioned above, many patients with UI in an acute care rehab setting do not improve Functional Independence Measure (FIM) status from admission to discharge. Currently there is no research available for the treatment of UI in an acute care rehab hospital, though it has been shown to be an issue with many of those admitted. So the question arises, \"Would addressing urinary incontinence with physical therapy interventions and behavioral modifications improve incontinence in this population during the acute rehab stage?\"","other_id":"61418","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":99,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Inclusion includes English-speaking women over the age of 18 who have been admitted to the\r\n        Rehabilitation Institute of Chicago with reports of urinary incontinence in the past 3\r\n        months. Those who report \"yes\" to the screening questions who fit the above criteria will\r\n        be screened by the principal investigator to ensure they fall into the criteria.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Non-English speaking women under the age of 18, or those that do not give consent to\r\n        participate in the study will not be enrolled. Also excluded will be any woman who has any\r\n        chance of being pregnant or having an active urinary tract infection. No women with active\r\n        infection lesions, unknown vaginal bleeding or those who have never had any kind of pelvic\r\n        examination will be included in the study. Other exclusion criteria include women with a\r\n        neurogenic bladder or admission FIM scores on sections Comprehension and Memory of below 4.\r\n        Women with reports of significant pelvic pain or recent pelvic surgery or radiation or\r\n        post-partum in last 6 months will be excluded.\r\n      ","sponsor":"Anne Deutsch","sponsor_type":"Other","conditions":"Urinary Incontinence","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: pelvic floor muscle training","description":"behavioral modification and pelvic floor muscle training"}],"outcomes":[{"outcome_type":"primary","measure":"Number of urinary incontinent episodes","time_frame":"per day"},{"outcome_type":"secondary","measure":"Urinary incontinence severity","time_frame":"participants will be followed for the duration of their hospital stay, an average of 2 weeks","description":"Sandvick Severity Scale"},{"outcome_type":"secondary","measure":"ICIQ-SF","time_frame":"participants will be followed for the duration of their hospital stay, average of 2 weeks","description":"quality of life"}]}
{"nct_id":"NCT01551641","start_date":"2012-01-31","phase":"Phase 2","enrollment":180,"brief_title":"Phase II Trial of Thalidomide Combined With Concurrent Chemoradiotherapy in Esophageal Cancer","official_title":"A Phase II Clinical Trial on VEGF Expression Interfered by Thalidomide Combined With Concurrent Chemoradiotherapy in Esophageal Cancer","primary_completion_date":"2016-03-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2016-03-31","last_update":"2016-02-17","description":"The purpose of this study is to down-regulate VEGF expression in esophageal cancer patients by thalidomide, so to improve their chemoradiotherapy effect. Patients with esophageal cancer receiving chemoradiotherapy were divided into different sub-group according to dynamic change of their VEGF level,and those showed increased or unchanged VEGF were added thalidomide at random. Efficacy and side effect of thalidomide combined with chemoradiotherapy were evaluated, and at the same time, activity of thalidomide on esophageal cancer and its clinical safely were assessed.","other_id":"CZEY-THA-001","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  cytologically or histologically confirmed esophageal carcinoma\r\n\r\n          -  age of 20 -80\r\n\r\n          -  Karnofsky performance status  70\r\n\r\n          -  no treatments prior to enrollment\r\n\r\n          -  at least one measurable lesion on CT, MRI or esophageal barium exam\r\n\r\n          -  normal functions of heart, lung, liver, kidney and bone marrow\r\n\r\n          -  blood exams qualified for chemotherapy, which included hemoglobulin 9 g/dl,\r\n             neutrophil 1.5109/L and platelet (PLT) 100109/L, creatinine 1.5 UNL\r\n\r\n          -  informed consent signed\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  prior treatments of chemotherapy or irradiation\r\n\r\n          -  poor bone marrow, liver and kidney functions, which would make chemotherapy\r\n             intolerable\r\n\r\n          -  contraindication for irradiation: complete obstruction of esophagus, deep esophageal\r\n             ulcer, fistula to mediastinum, or haematemesis\r\n\r\n          -  participating in other clinical trials\r\n\r\n          -  pregnancy, breast feeding, or not adopting birth control\r\n\r\n          -  drug or alcohol addiction, uncontrolled epileptic seizure, or psychotic with no\r\n             ability of self control\r\n\r\n          -  coexisted morbidities that investigators believed not suitable for chemoradiation\r\n      ","sponsor":"Changzhou No.2 People's Hospital","sponsor_type":"Other","conditions":"Esophageal Cancer","interventions":[{"intervention_type":"Other","name":"Other: chemoradiotherapy","description":"Patients only receive concurrent chemoradiotherapy if their serum VEGF level decrease."},{"intervention_type":"Drug","name":"Drug: thalidomide","description":"Patients will be given thalidomide combined with concurrent chemoradiotherapy if their serum VEGF level increase or unchanged."},{"intervention_type":"Other","name":"Other: without thalidomide","description":"Patients only receive concurrent chemoradiotherapy if their serum VEGF level increase or unchanged"}],"outcomes":[{"outcome_type":"primary","measure":"Treatment efficacy","time_frame":"3 months after completion of treatment","description":"Treatment efficacy were evaluated by the indexes as Locoregional tumor response. Locoregional tumor response will be evaluated 3 months after completion of treatment according to Response Evaluation Criteria in Solid Tumors (RECIST)."},{"outcome_type":"secondary","measure":"Overall survival (OS)","time_frame":"1 year and 3 years after completion of treatment","description":"Overall survival (OS) will be evaluated 1 year and 3 years after completion of treatment using Kaplan-Meier model."},{"outcome_type":"secondary","measure":"Local progression-free survival (LPFS)","time_frame":"1 year and 3 years after completion of treatment","description":"1 year and 3 years after completion of treatment using Kaplan-Meier model."},{"outcome_type":"secondary","measure":"Safety","time_frame":"1 week after completion of treatment","description":"All patients are to be estimated Quality Of Life(such as dizzy, somnolence, queasiness and vomit,anaphylaxis incidence) ,acute radiation reactions such as acute radiation esophagitis and tracheitis incidence(evaluated by the Radiation Therapy Oncology Group (RTOG) toxicity criteria),complete blood cell count(such as leukocyte, neutrophil,hemoglobulin, platelet level), serum biochemistry(such as creatinine level)."}]}
{"nct_id":"NCT01659710","start_date":"2012-01-31","enrollment":220,"brief_title":"Effects of Medical Complexity Using GMA on Lurie Children's In- and Outpatients","official_title":"Effects of Medical Complexity on the Development of Fidgety Movements and Feasibility of Screening Utilizing the General Movement Assessment for Lurie Children's ICU Patients and Graduates","primary_completion_date":"2018-03-31","study_type":"Observational","rec_status":"Unknown status","last_update":"2015-08-13","description":"The purpose of this study is to research a new type of test for cerebral palsy that can be performed earlier, at 10-15 weeks of age (after the due date for premature infants). The test involves a standardized video recording of a baby's natural movements for about 10 minutes. The video recorded movements are evaluated by a special trained observer and also by a computer program. There are some small studies from Europe that suggest that this type of evaluation may be accurate in early diagnosis of cerebral palsy. However, the investigators do not know if this type of evaluation is reliable in large groups of infants, including infants from Children's Memorial Hospital, who tend to be sicker and have more complicated illnesses than many of the European infants. The investigators would therefore like to evaluate whether this type of video recording could be used in the future for early diagnosis of cerebral palsy.","other_id":"2012-14808","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","maximum_age":5,"population":"Children's Memorial ICU Patients and Graduates","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Admitted to the NICU/CICU and remain hospitalized at 10-15 weeks postmenstrual age\r\n\r\n          -  Birth at <28 weeks gestation\r\n\r\n          -  Birth weight <1000 grams\r\n\r\n          -  Neurologic risk factors (HIE, abnormal imaging, neonatal seizures, microcephaly)\r\n\r\n          -  Cardiac surgery during first 3 months of life\r\n\r\n          -  Severe chronic lung discharge defined as the need for mechanical ventilation at 36\r\n             weeks post-menstrual age\r\n\r\n          -  Discharged home on supplemental oxygen (or if still hospitalized, requiring oxygen at\r\n             44 weeks post-menstrual age)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Significant malformations/amputations of the extremities\r\n\r\n          -  Recovering from a surgical procedure within 4 weeks of the assessment\r\n\r\n          -  Physiologic instability precluding movement of the hospital bed or peripheral IV lines\r\n             that might affect movement of an extremity medication for the purpose of ongoing\r\n             sedation\r\n      ","sponsor":"Ann & Robert H Lurie Children's Hospital of Chicago","sponsor_type":"Other","conditions":"Medically Complex Infants","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Presence of cerebral palsy","time_frame":"24 months (+/- 6 months) and 4 years (+/- 1 year) of age"}]}
{"nct_id":"NCT01779726","start_date":"2012-01-31","phase":"N/A","enrollment":331,"brief_title":"Efficiency of Diagnostic Strategy for Fast Track Lung Cancer Diagnosis","official_title":"Efficiency of Diagnostic Strategy for Fast Track Lung Cancer Diagnosis. A Randomised Controlled Trial.","primary_completion_date":"2013-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-01-31","last_update":"2014-12-03","description":"Annually, 4,200 new cases of lung cancer are diagnosed in Denmark. The stage of the disease is an important prognostic factor as an advanced stage reduces the opportunity for surgical intervention and other curative treatment. In denmark, as in many other countries, a fast track evaluation for lung cancer has been introduced in 2008. When the general practitioners refer patients through the fast track, the majority of patients make their first visit to the Department of Pulmonary Medicine. After this visit, further investigation is initiated, which is often a CT scan of the chest and the upper abdomen. We dont know Whether this is the most appropriate organisation. The aim of this project is to evaluate the way lung cancer patients are examined through the fast track and the impact of chest CT before an evaluation by a chest physician. Investigators want to randomise all patients referred for the existing fast track to either direct CT scan of chest and upper abdomen or to evaluation by the chest physician, in order to test: A) Fast track performance measured by number of CT scans and chest physician specialist time per diagnosis, and whether there is a difference between the intervention and the control group.","other_id":"118/2011","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"None (Open Label)","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  All patients referred to fast track evaluation (lung department, Aarhus university\r\n             hospital) from primary care.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Not referred from general practice\r\n      ","sponsor":"University of Aarhus","sponsor_type":"Other","conditions":"Lung Cancer","interventions":[{"intervention_type":"Radiation","name":"Radiation: CT scan before chest physician","description":"Patients referred to department of lung medicine are randomised according to the month of birth. Patients born in even months are CT scan before a consultation with a chest physician"},{"intervention_type":"Radiation","name":"Radiation: Usual diagnostic workup","description":"Patients born in odd months seen in the department of lung medicine by a chest physician and maybe then CT scanned (usual workup practice according to the fast track evaluation)"}],"outcomes":[{"outcome_type":"primary","measure":"Chest physician time","time_frame":"2013","description":"Time (in minutes) spent by a chest physician pr patient"},{"outcome_type":"secondary","measure":"Satisfaction with new organisation","time_frame":"2013","description":"Measured with a qualitative focus interview with staff a the Department of lung medicine (doctors, nurses and secretary)."}]}
{"nct_id":"NCT01333046","start_date":"2012-01-31","phase":"Phase 1","enrollment":74,"brief_title":"Administration of TAA-Specific CTLs; Hodgkin or Non-Hodgkin Lymphoma; TACTAL","official_title":"Administration of Tumor-Associated Antigen (TAA)-Specific Cytotoxic T-Lymphocytes to Patients With Active or Relapsed Hodgkin or Non-Hodgkin Lymphoma","primary_completion_date":"2022-05-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2027-05-01","last_update":"2021-03-11","description":"Patients have a type of lymph gland disease called Hodgkin or non-Hodgkin lymphoma which has come back, or may come back, or has not gone away after treatment, including the standard treatment known for these diseases. This a research study using special immune system cells called tumor associated antigen (TAA)-specific cytotoxic T lymphocytes, a new experimental therapy. This sort of therapy has been used previously to treat Hodgkin or non-Hodgkin lymphomas that show proof of infection with Epstein-Barr virus (EBV), the virus that causes infectious mononucleosis (\"mono\" or the \"kissing disease\"). EBV is found in cancer cells of up to half of all patients with Hodgkin's and non-Hodgkin lymphoma. This suggests that it may play a role in causing lymphoma. The cancer cells infected by EBV are able to hide from the body's immune system and escape being killed. Investigators tested whether special white blood cells, called T cells, that were trained to kill EBV-infected cells could affect these tumors, and in many patients it was found that giving these trained T cells caused a complete or partial response. However, many patients do not have EBV in their lymphoma cells; therefore investigators now want to test whether it is possible to direct these special T cells against other types of proteins on the tumor cell surface with similar promising results. The proteins that will be targeted in this study are called tumor associated antigens (TAAs) - these are cell proteins that are specific to the cancer cell, so they either do not show or show up in low quantities on normal human cells. In this study, we will target five TAAs which commonly show on lymphoma, called: NY-ESO-1, MAGEA4, PRAME, Survivin and SSX. This will be done by using special types of T cells called cytotoxic T lymphocytes (CTLs) generated in the lab. In addition, some adult patients will receive a drug called azacytidine before giving the T cells. We hope that the combination helps the T cells work better.","other_id":"H-27471-TACTAL","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        PROCUREMENT:\r\n\r\n          1. Any patient regardless of sex, with a diagnosis of Hodgkin or non-Hodgkin lymphoma.\r\n\r\n          2. Life expectancy of 6 weeks or greater.\r\n\r\n          3. Hgb greater than or equal to 7.0\r\n\r\n          4. Patient and,or parent,guardian able to give informed consent.\r\n\r\n        TREATMENT:\r\n\r\n          1. Any patient regardless of sex, with a diagnosis of Hodgkin or non-Hodgkin lymphoma:\r\n\r\n             Group A: Patients greater than or equal to 18 years old\r\n\r\n               -  with active disease:\r\n\r\n                    -  in second or subsequent relapse.\r\n\r\n                    -  in first relapse for indolent lymphoma after first-line therapy for relapse.\r\n\r\n                    -  or first relapse if immunosuppressive chemotherapy contraindicated.\r\n\r\n                    -  primary refractory disease or if persistent disease after first-line therapy\r\n                       of relapse.\r\n\r\n               -  or multiply relapsed patients in remission who are at a high risk of relapse.\r\n\r\n               -  or the lymphoma is a second malignancy e.g. a Richters transformation of CLL\r\n                  after failing front line therapy.\r\n\r\n             OR\r\n\r\n             Group B: Patients greater than or equal to 18 years old after autologous or syngeneic\r\n             SCT (as adjuvant therapy).\r\n\r\n             OR\r\n\r\n             Group C: azacytidine plus multiTAA-T cells Patients greater than or equal to 18 years\r\n             old\r\n\r\n               -  with active disease in:\r\n\r\n                    -  second or subsequent relapse\r\n\r\n                    -  first relapse for indolent lymphoma after first line therapy for relapse\r\n\r\n                    -  first relapse if immunosuppressive chemotherapy contraindicated\r\n\r\n               -  with primary refractory disease or persistent disease after first line therapy of\r\n                  relapse\r\n\r\n               -  or lymphoma as a second malignancy e.g. a Richters transformation of CLL after\r\n                  failing front line therapy\r\n\r\n             OR\r\n\r\n             GROUP D: Patients less than 18 yrs old\r\n\r\n               -  with active disease in:\r\n\r\n                    -  second or subsequent relapse\r\n\r\n                    -  first relapse for indolent lymphoma after first line therapy for relapse\r\n\r\n                    -  first relapse if immunosuppressive chemotherapy contraindicated\r\n\r\n               -  with primary refractory disease or persistent disease after first line therapy of\r\n                  relapse\r\n\r\n               -  with lymphoma as a second malignancy e.g. a Richters transformation of CLL after\r\n                  failing front line therapy\r\n\r\n          2. Life expectancy of 6 weeks or greater.\r\n\r\n          3. Pulse oximetry of more than 95 percent on room air in patients who previously received\r\n             radiation therapy.\r\n\r\n          4. Karnofsky,Lansky score of 50 or greater.\r\n\r\n          5. Creatinine 2X or less of upper limit of normal for age.\r\n\r\n          6. Patients should have been off other investigational therapy for one month prior to\r\n             entry in this study.\r\n\r\n          7. Patients should have been off conventional therapy for at least 1 week prior to entry\r\n             in this study, including rituximab.\r\n\r\n          8. Patient and,or parent,guardian able to give informed consent.\r\n\r\n          9. Due to unknown effects of this therapy on a fetus, pregnant women are excluded from\r\n             this research. The male partner should use a condom. Females of child-bearing\r\n             potential should use of at least two forms of contraception unless female has had a\r\n             hysterectomy or tubal ligation.\r\n\r\n         10. Bilirubin 2X or less of upper limit of normal, AST 3X or less than the upper limit of\r\n             normal, and Hgb greater than or equal to 7.0\r\n\r\n             GROUP C (aza) Only:\r\n\r\n         11. Platelets greater than 25,000\r\n\r\n        Exclusion Criteria:\r\n\r\n        PROCUREMENT:\r\n\r\n          1. Patients with severe intercurrent infection.\r\n\r\n          2. Patients with active HIV infection at time of procurement (can be pending at the time\r\n             of blood draw).\r\n\r\n          3. Patients receiving systemic corticosteroids.\r\n\r\n        TREATMENT:\r\n\r\n          1. Patients with severe intercurrent infection.\r\n\r\n          2. Patients receiving systemic corticosteroids.\r\n\r\n          3. Pregnant breastfeeding.\r\n\r\n          4. Active viral infection with HIV or hepatitis type B or C. \"Active\" infection defined\r\n             as infectious disease testing indicating that patient blood is reactive for Hep B, C\r\n             and/or HIV and confirmed using PCR to measure viral load.\r\n\r\n             GROUP C (aza) Only:\r\n\r\n          5. Abnormal coagulation parameters (PT greater than 15 seconds, PTT greater than 40\r\n             seconds, and/or INR greater than 1.5)\r\n\r\n          6. Significant active cardiac disease within the previous 6 months including:\r\n\r\n               1. NYHA class 4 CHF\r\n\r\n               2. Unstable angina\r\n\r\n               3. Myocardial infarction\r\n\r\n          7. Known or suspected hypersensitivity to azacitidine or mannitol\r\n\r\n          8. Patients with advanced malignant hepatic tumors.\r\n      ","sponsor":"Baylor College of Medicine","sponsor_type":"Other","conditions":"Hodgkin Lymphoma|Non-Hodgkin Lymphoma|Hodgkin Disease","interventions":[{"intervention_type":"Biological","name":"Biological: Antigen-Escalation Stage","description":"Antigen-Escalation Stage\r\nEach patient will receive 2 injections at the same dose (5 x 10^6 cells/m2), 28 days apart, according to the following schedules:\r\nSchedule One:\r\nDay 0: PRAME-specific T cells\r\nDay 28: PRAME- and SSX-specific T cells\r\nSchedule Two:\r\nDay 0: PRAME- and SSX-specific T cells\r\nDay 28: PRAME/SSX/MAGE-specific T cells\r\nSchedule Three:\r\nDay 0: PRAME/SSX/MAGE-specific T cells\r\nDay 28: PRAME/SSX/MAGE/NY-ESO specific T cells\r\nSchedule Four:\r\nDay 0: PRAME/SSX/MAGE/NY-ESO specific T cells\r\nDay 28: PRAME/SSX/MAGE/NY-ESO/Survivin-specific T cells"},{"intervention_type":"Biological","name":"Biological: Dose-Escalation Stage","description":"Dose-Escalation Stage\r\nThree different dosing schedules will be evaluated. Each patient will receive 2 injections at the same dose, 14 days apart, according to the following dosing schedules:\r\nDL1: Day 0 and Day 14: 5 x 10^6 cells/m^2\r\nDL2: Day 0 and Day 14: 1 x 10^7 cells/m^2\r\nDL3: Day 0 and Day 14: 2 x 10^7 cells/m^2"},{"intervention_type":"Biological","name":"Biological: azacytidine and multiTAA T cells Stage","description":"Up to 15 patients will be treated with 3 cycles of aza at a dose of 75 mg/m2 I.V. administered for 5 days/cycle followed, within 28 days of the last aza dose, by two infusions (on Day 0 and Day 14) of multi-TAA specific CTLs at a fixed dose of 1x10^7 cells/m2. If drug-related myelosuppression occurs aza dosing will be modified, according to the following:\r\nANC >1,000 or Platelets >50,000 (or any other grade I AE attributable to aza)\r\nAdjustment: None\r\nANC 500-1000 or Platelets 25,000-50,000 (or any other grade II-III AE attributable to aza)\r\nAdjustment: 50% dose reduction\r\nANC <500 or any episode of febrile neutropenia or platelets <25,000 or any episode of bleeding attributed to thrombocytopenia (or any other grade IV or higher AE attributable to aza)\r\nAdjustment: Discontinue drug, can proceed with CTL infusion if eligible within 28 days of last aza infusion"},{"intervention_type":"Biological","name":"Biological: Pediatric multiTAA T cells Stage","description":"Patients < 18 years old will receive two infusions (on Day 0 and Day 14) of multi-TAA specific T cells at a fixed dose of 1x10^7 cells/m2. We will enroll and infuse at least 5 adolescents on the pediatric arm before opening to all patients."}],"outcomes":[{"outcome_type":"primary","measure":"Assessment of patients with adverse events","time_frame":"8 weeks","description":"To determine the safety of 2 intravenous injections of autologous TAA-specific cytotoxic T lymphocytes (CTLs) in patients with Hodgkin or non-Hodgkin lymphoma."},{"outcome_type":"primary","measure":"Number of Patients with treatment related Serious Adverse Events","time_frame":"8 weeks","description":"To determine whether infusion of TAA-specific T cells targeting multiple tumor antigens in combination with azacytidine is safe"},{"outcome_type":"secondary","measure":"Obtain information on the expansion, persistence and anti-tumor effects of the adoptively-transferred TAA-specific CTLs","time_frame":"1 year","description":"Information on the expansion, persistence and anti-tumor effects of the adoptively transferred tumor-specific CTLs will be analyzed for the immunological parameters based on multimer analysis, intracellular cytokine staining and ELIspot assays to assess the frequency of cells secreting γ-IFN using the descriptive statistics such as mean, median, standard deviation at each timepoint."},{"outcome_type":"secondary","measure":"Assessment of increasing the spectrum of epitopes/antigens","time_frame":"1 year","description":"To determine whether CTL infusions increase the spectrum of epitopes/antigens targeted by endogenous T cells (epitope spreading)."}]}
{"nct_id":"NCT02421848","start_date":"2012-01-31","enrollment":112,"brief_title":"Lean Mass Evaluation of Cirrhotic Patients With Ascites With the Use DXA","official_title":"Body Composition Evaluation of Cirrhotic Patients With Ascites","primary_completion_date":"2012-05-31","study_type":"Observational","rec_status":"Completed","completion_date":"2014-12-31","last_update":"2015-04-21","description":"Malnutrition due to liver disease is common, however, their detection is difficult. The parameters used for nutritional assessment in clinical practice have limited use in this patient population. From this perspective, this study proposes to develop predictive equations for body composition for electrical bioimpedance (BIA) in cirrhotic patients. Besides being a fast and risk free, the BIA offers the additional advantage of low cost compared to other methods that assess body composition (BC). Will be selected patients male with liver cirrhosis (n = 112) of the Liver Transplant Clinic of the Hospital of the Clinicas, Faculty of Medicine, University of So Paulo. This pioneering study is of great clinical importance because malnutrition is a relevant factor in the prognosis of liver disease and there is not efficient method in clinical practice to properly assess the body composition in this population.","other_id":"U So Paulo","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"Male","minimum_age":18,"population":"Will be selected patients male with liver cirrhosis (n = 112) of the Liver Transplant\r\n        Clinic of the Hospital of the Clinicas, Faculty of Medicine, University of So Paulo.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adults (18-60 years) of both sexes;\r\n\r\n          -  Signing the free and informed consent;\r\n\r\n          -  Show interest, conditions and availability to participate in all procedures included\r\n             in the study protocol;\r\n\r\n          -  liver cirrhosis Carrier\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Refusal to participate;\r\n\r\n          -  Patients who have made liver transplantation;\r\n\r\n          -  Physical Amputation;\r\n\r\n          -  Swelling in the lower limb;\r\n      ","sponsor":"University of Sao Paulo","sponsor_type":"Other","conditions":"Liver Cirrhosis","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Body Composition Evaluation of Cirrhotic Patients With Ascites (estimated by bioelectrical impedance analysis and by reference method (DXA)","time_frame":"two years"}]}
{"nct_id":"NCT01486420","start_date":"2012-01-31","phase":"N/A","enrollment":166,"brief_title":"Open Surgery Versus Corticosteroid Injections in Treatment of Trigger Finger","official_title":"Open Surgery Versus Ultrasound Guided Local Corticosteroid Injections in Treatment of Trigger Finger - a Randomized Controlled Trial.","primary_completion_date":"2015-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-10-31","last_update":"2015-10-28","description":"The purpose of the study is to investigate which strategy is superior in trigger finger Quinell grade IIb-V; conventional open surgery or ultrasound guided corticosteroid injections.","other_id":"M-20110157","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":99,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Trigger finger Quinell grade IIb-V in digit I-V\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Former treatment of Trigger finger in affected digit\r\n\r\n          -  Dupuytrens contracture in affected digit\r\n\r\n          -  Allergies or intolerance to used medications\r\n\r\n          -  Rheumatoid Arthritis\r\n\r\n          -  Insulin dependent Diabetes Mellitus\r\n\r\n          -  Amyloidosis\r\n\r\n          -  Mucopolysaccharidosis\r\n\r\n          -  Already included in study with another digit\r\n      ","sponsor":"Jeppe Lange, MD","sponsor_type":"Other","conditions":"Trigger Finger","interventions":[{"intervention_type":"Procedure","name":"Procedure: Corticosteroid injections","description":"Corticosteroid injections in and around A1-pulley."},{"intervention_type":"Procedure","name":"Procedure: Open surgery","description":"Open A1-pulley release"}],"outcomes":[{"outcome_type":"primary","measure":"Quinell grade","time_frame":"12 months","description":"Dicotomized outcome defined as +/- failure. Failure defined as Quinell grade equal to or above IIb.\r\nQuinell grade defined as: I Normal movement, IIa normal movement with pain/tenderness to A1-pulley, IIb anamnestic triggering but not evident at clinical exam, III triggering without locking, IV triggering with locking but actively correctable, V Locked digit, passive correctable only."},{"outcome_type":"secondary","measure":"Numerical Rating Scale (NRS) score","time_frame":"12 weeks","description":"Pain following either procedure measured by NRS (score 0-10, 10 is severe pain)"},{"outcome_type":"secondary","measure":"infection","time_frame":"12 weeks","description":"Infection occurence following either procedure"}]}
{"nct_id":"NCT02823275","start_date":"2012-01-31","phase":"N/A","enrollment":13,"brief_title":"Post Operative Quality of Life and Pain in Ankle Fractures: Cast Versus Functional Treatment","official_title":"Post Operative Evaluation of Quality of Life and Pain in Ankle Fractures: Cast Immobilisation Versus Functional Treatment","primary_completion_date":"2012-11-30","study_type":"Interventional","rec_status":"Terminated","completion_date":"2012-11-30","last_update":"2016-07-06","description":"Rationale: Ankle fractures are common traumatic lesions. In order to restore the anatomical situation of the ankle joint to prevent posttraumatic arthritis, these fractures often need surgical treatment. Both cast immobilisation and functional treatment have proved to be reliable postoperative treatment regimes. Insight into the quality of life and the level of pain is necessary to determine if these treatments can be related to higher patient satisfaction and earlier resumption of daily activities and work. Objective: The aim of this study is to examine two postoperative treatments for surgically corrected ankle fractures. Postoperative, direct functional mobilisation is compared to short term plaster cast fixation. The focus of this study is on quality of life, pain and the use of pain medication, and resumption of work and daily activities. Main study parameters/endpoints: Quality of life, Function, pain, swelling, daily activities and work, disabilities (pain disability index), complications","other_id":"683-250210-Nicolaas","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age 18-65 at the time of surgery\r\n\r\n          -  Ankle fractures needing operative correction\r\n\r\n          -  Weber type B or C, Lauge Hansen type supination-adduction, supination-external\r\n             rotation and pronation-external rotation\r\n\r\n          -  Closed fractures\r\n\r\n          -  Postoperative stable for exercise\r\n\r\n          -  Operated at the University Medical Centre St Radboud, Nijmegen or Alysis Zorggroep,\r\n             Rijnstate Hospital, Arnhem\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Open fractures\r\n\r\n          -  Fractures with complete dislocation of the ankle joint\r\n\r\n          -  Body Mass Index > 30\r\n\r\n          -  Previous ankle fracture on the affected side\r\n\r\n          -  Concomitant traumatic injuries reducing the ability for postoperative mobilization\r\n\r\n          -  Pre-existent use of pain medication, medication affecting fracture- and wound healing\r\n\r\n          -  Postoperative unstable for exercise\r\n\r\n          -  Co-morbidity: pain syndromes, Fontaine IIB, III and IV, symptomatic venous\r\n             insufficiency, auto-immune disorders, rheumatic arthritis\r\n      ","sponsor":"Rijnstate Hospital","sponsor_type":"Other","conditions":"Ankle Fractures","interventions":[{"intervention_type":"Other","name":"Other: Functional mobilisation","description":"functional mobilisation"},{"intervention_type":"Other","name":"Other: Short term plaster cast fixation","description":"2 weeks cast immobilisation"}],"outcomes":[{"outcome_type":"primary","measure":"pain","time_frame":"6 weeks","description":"Visual Analog Pain Scale"},{"outcome_type":"primary","measure":"Pain medication used","time_frame":"6 weeks","description":"amount of pain medication used"}]}
{"nct_id":"NCT01516645","start_date":"2012-01-31","phase":"Phase 1","enrollment":14,"brief_title":"Phase 1 Study of KHK2898 in Subjects With Advanced Solid Tumors","official_title":"Phase 1, Open-Label, Dose Escalation Study of Anti-CD98 Monoclonal Antibody KHK2898 as Monotherapy in Subjects With Advanced Solid Tumors Who No Longer Respond to Standard Therapy or For Whom No Standard Therapy Is Available","primary_completion_date":"2015-05-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2015-05-31","last_update":"2017-03-16","description":"This is a two-part, Phase 1 open label, single-center, dose escalation study of KHK2898 as monotherapy in subjects with advanced solid tumors who no longer respond to standard therapy or for whom no standard therapy is available.","other_id":"KHK2898-001","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. The subject has a histopathological-documented, measurable or non-measurable, locally\r\n             advanced unresectable primary or metastatic solid tumor unresponsive to standard\r\n             therapy or for which there is no standard therapy available.\r\n\r\n          2. The subject has PD during or following the last treatment regimen as defined by the\r\n             Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1 guidelines)11.\r\n\r\n          3. The subject has a life expectancy >3 months.\r\n\r\n          4. The subject has an Eastern Cooperative Oncology Group (ECOG) performance status (PS)\r\n             score of  2 at study entry.\r\n\r\n          5. The subject is  18 years of age.\r\n\r\n          6. The subject has a pre-study echocardiogram or multigated acquisition scan with left\r\n             ventricular ejection fraction  50%.\r\n\r\n          7. The subject has recovered to Grade  1 by the CTCAE v 4.0313, from the effects of\r\n             recent surgery, radiotherapy, chemotherapy, hormonal therapy, or other targeted\r\n             therapies for cancer, with the exception of alopecia or peripheral neuropathy (the\r\n             latter of which must have resolved to Grade  2).\r\n\r\n          8. The subject has preserved organ function as defined below. All parameters must be\r\n             evaluated within 7 days prior to the first dose of KHK2898.\r\n\r\n               -  8-a) Aspartate aminotransferase and alanine aminotransferase  2.5 Upper limits\r\n                  of normal (ULN), or  5.0  ULN in subjects with metastatic liver disease\r\n\r\n               -  8-b) Hemoglobin  9 g/dl (without transfusion in the preceding 7 days)\r\n\r\n               -  8-c) Total bilirubin  1.5  ULN\r\n\r\n               -  8-d) Creatinine  1.5  ULN\r\n\r\n               -  8-e) ANC  1.5  109/L (unsupported by growth factors in the preceding 21 days)\r\n\r\n               -  8-f) Platelets  100  109/L (without transfusion or growth factor in the\r\n                  preceding 7 days)\r\n\r\n          9. The subject has provided signed informed consent. Written informed consent must be\r\n             obtained prior to performing any study-related procedures. For subject < 21 years old\r\n             who is not married, written informed consent must be taken from the subject and\r\n             his/her parents/ legal guardians.\r\n\r\n         10. Women of childbearing potential (WOCBP) must have a negative pregnancy test at study\r\n             entry. Subjects not considered WOCBP are those without menses for 24 consecutive\r\n             months, and those who have undergone hysterectomy and/or bilateral\r\n             salpingo-oophorectomy. WOCBP must be willing to use acceptable methods of birth\r\n             control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with\r\n             spermicide, or condom with spermicide, or abstinence) for the duration of the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. The subject has received anti-cancer chemotherapy, hormonal therapy (other than LH-RH\r\n             agonists/pure antagonists for prostate cancer, which are allowed to be continued if\r\n             the subject has already been on one for at least 2 months at the time of enrollment),\r\n             radiotherapy, immunotherapy, or investigational agents within 4 weeks (6 weeks for\r\n             mitomycin C and nitrosoureas) prior to the first dose of KHK2898.\r\n\r\n          2. The subject has received monoclonal antibodies within 4 weeks of the first dose of\r\n             KHK2898.\r\n\r\n          3. The subject had major surgery within 4 weeks prior to the first dose of KHK2898.\r\n\r\n          4. The subject has known symptomatic brain metastases (screening/baseline MRI of the\r\n             brain is only required when there is clinical suspicion of central nervous system\r\n             (CNS) involvement or past history of treated brain metastasis). Subjects with treated\r\n             brain metastasis (radiotherapy and/or surgery) will be eligible if:\r\n\r\n               -  4-a) They have completed treatment for their brain metastasis > 4 weeks prior to\r\n                  scheduled study treatment start date;\r\n\r\n               -  4-b) They are neurologically stable;\r\n\r\n               -  4-c) They are not receiving corticosteroids or corticosteroids in doses no\r\n                  greater than physiological replacement (e.g., dexamethasone < 1.5 mg/day); and\r\n\r\n               -  4-d) They have a screening/baseline MRI scan of the brain that specifically\r\n                  verifies no evidence of CNS hemorrhage and no active gadolinium enhancing\r\n                  lesions; and\r\n\r\n               -  4-e) Subjects with primary brain/CNS malignancy (e.g., gliomas, lymphomas) are\r\n                  excluded.\r\n\r\n          5. The subject has leptomeningeal disease.\r\n\r\n          6. The subject is pregnant (confirmed by beta human chorionic gonadotrophin [-HCG]) or\r\n             is lactating.\r\n\r\n          7. The subject has a significant uncontrolled intercurrent illness including, but not\r\n             limited to: ongoing or active infection requiring parenteral antibiotics, clinically\r\n             significant cardiac disease [class II, III, or IV of the New York Heart Association\r\n             classification (NYHA)],14 unstable angina pectoris, myocardial infarction within 6\r\n             months or is post angioplasty or stenting within 6 months, uncontrolled hypertension\r\n             (i.e., systolic blood pressure (BP) > 150 mm Hg, diastolic BP > 90 mm Hg), found on\r\n             two consecutive measurements separated by a 1-week period, clinically significant\r\n             cardiac arrhythmia, or uncontrolled diabetes.\r\n\r\n          8. The subject has known human immunodeficiency virus infection or acquired\r\n             immunodeficiency syndrome-related illness.\r\n\r\n          9. The subject has known active hepatitis B or C or other active (non-malignant) liver\r\n             disease.\r\n\r\n         10. The subject has a psychiatric illness, disability or social situation that would\r\n             compromise the subject's safety, ability to provide consent, or limit his/her\r\n             compliance with study requirements.\r\n\r\n         11. The subject has experienced a hypersensitivity reaction to monoclonal antibodies or\r\n             other therapeutic proteins, and the reaction could not be controlled or prevented on\r\n             subsequent infusion with standard therapies such as antihistamines, 5-HT3 antagonists,\r\n             or corticosteroids.\r\n\r\n         12. The subject has a history of another primary cancer, with the exception of: a)\r\n             curatively resected nonmelanomatous skin cancer, b) curatively treated cervical\r\n             carcinoma in-situ, or c) other primary solid tumor treated with curative intent and no\r\n             known active disease present and no treatment administered during the last 3 years.\r\n\r\n         13. The subject requires concomitant medication with any of the following prohibited\r\n             medications: active prohibited anti neoplastic treatment other than the\r\n             investigational product KHK2898; other anti-cancer therapies such as cytotoxic\r\n             chemotherapy; anti-cancer hormonal therapy other than LH-RH agonists/pure antagonists\r\n             for prostate cancer, which are allowed to be continued if the subject has already been\r\n             on one for at least 2 months at the time of enrollment; immunotherapies including\r\n             other monoclonal antibodies, interferons, cancer vaccines, etc; targeted small\r\n             molecule anti-cancer therapies; and radiation therapy (radiation therapy should be\r\n             completed prior to enrollment on this study).\r\n\r\n         14. Prior stem cell or bone marrow transplant.\r\n\r\n         15. Subjects received vaccination within 8 weeks from the first administration of KHK2898.\r\n      ","sponsor":"Kyowa Kirin Co., Ltd.","sponsor_type":"Industry","conditions":"Solid Tumour","interventions":[{"intervention_type":"Drug","name":"Drug: KHK2898","description":"injection"}],"outcomes":[{"outcome_type":"primary","measure":"Adverse Event collection and assessment","time_frame":"at least 28 days or up to 24 weeks","description":"Adverse Event collection and assessment will be done for all 54 potentially treated subjects to assess the safety, tolerability, and determine the DLTs, maximum tolerated dose (MTD)."},{"outcome_type":"secondary","measure":"Evaluate preliminary evidence of efficacy","time_frame":"eight weeks","description":"Response and progression in subjects with solid tumors and measurable disease will be evaluated using RECIST criteria v 1.1. Evaluations will include: objective response (CR + PR) and clinical benefit (CR + PR + SD)."},{"outcome_type":"secondary","measure":"Profile of Pharmacokinetics","time_frame":"Pre-dose, 1, 2, 4, 6-8, 24, 48, 72, 96, 168, 240-288, 336 hours post-dose","description":"maximum concentration (Cmax), area under the curve (AUC), half-life (t1/2), clearance (Cl), and apparent volume of distribution in the terminal elimination phase (Vz)."}]}
{"nct_id":"NCT01520103","start_date":"2012-01-31","phase":"Phase 2","enrollment":139,"brief_title":"Study to Compare Vinorelbine In Combination With the mTOR Inhibitor Everolimus vs. Vinorelbin Monotherapy for Second-line Treatment in Advanced Breast Cancer","official_title":"Randomized Phase II Study to Compare Vinorelbine In Combination With the mTOR Inhibitor Everolimus vs. Vinorelbin Monotherapy for Second-line Treatment in Advanced Breast Cancer","primary_completion_date":"2016-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-10-31","last_update":"2017-08-09","description":"The purpose of this study is Examination of the superiority of a combination of vinorelbine with the mTOR Inhibitor Everolimus vs. vinorelbine monotherapy for second-line treatment in advanced breast cancer.","other_id":"AIO-MAM-0110","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        1 .Dated and signed patient informed consent before start of any in the protocol specified\r\n        procedures 2. Histologically or cytologically confirmed Her2/neu negative, metastatic or\r\n        locally advanced breast cancer, including inoperable local relapse, with measurable or\r\n        non-measurable lesions for which\r\n\r\n          -  a palliative second line chemotherapy is indicated. Antihormone palliative\r\n             pretreatments do not count as separate treatment lines\r\n\r\n          -  treatment with anthracycline and/or taxanes has failed or is not suitable\r\n\r\n          -  which cannot be adequately treated by operation or radiotherapy on its own 3. An\r\n             exclusive anti-hormone therapy is not indicated for the patient 4. ECOG Performance\r\n             Status of 0-2 5. Women >= 18 years of age 6. Life expectancy of at least 12 weeks 7.\r\n             Adequate bone marrow, liver and renal function (according to SmPC of Vinorelbine,\r\n             Afinitor) based on laboratory assessments raised within 7 days prior to start of\r\n             study treatment:\r\n\r\n          -  Haemoglobin >= 9.0 g/dl\r\n\r\n          -  Absolute neutrophil count (ANC) >= 2/mm\r\n\r\n          -  Thrombocytes >= 100/l\r\n\r\n          -  INR >= 2\r\n\r\n          -  Serum bilirubin =< 1.5x upper limit of normal ( in patients with known Gilbert\r\n             syndrome, total bilirubin =< 3x upper limit of normal, with direct bilirubin =< 1.5x\r\n             upper limit of normal\r\n\r\n          -  ALT and AST =< 2.5x upper limit of normal (=< 5x upper limit of normal in subjects\r\n             with liver metastases)\r\n\r\n          -  Serum cholesterol =< 300 mg/dl or 7.75 mmol/l and triglycerides =< 2.5x upper limit of\r\n             normal (with lipid lowering drugs permitted)\r\n\r\n          -  Serum creatinin =< 2x upper limit of normal 8. Documentation of a negative pregnancy\r\n             test in women of childbearing potential within 7 days prior to start of study. Sexual\r\n             active pre-menopausal women are required to use adequate contraception throughout the\r\n             duration of the study, except for oestrogen containing contraceptives\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Previous treatment with Vinorelbine or an inhibitor of mTOR\r\n\r\n          2. Treatment with other study medication within 28 days before start of treatment\r\n\r\n          3. Patients who have received prior radiotherapy to  25% of the bone marrow\r\n\r\n          4. Other tumours in the previous 5 years with exception of an adequately treated basal\r\n             cell carcinoma of the skin or a preinvasive cervix carcinoma\r\n\r\n          5. Simultaneous use of known CYP3A4 inducers (e.g. Phenytoin, Rifampicin) or inhibitors\r\n             of this enzyme (e.g. Itraconazole, Ketoconazole), therefore also use of mistletoe, St\r\n             John's wort or grapefruit juice\r\n\r\n          6. Patients to whom at least one of the conditions applies:\r\n\r\n               -  Substance abuse\r\n\r\n               -  medical, psychological or social conditions that may interfere with the patient's\r\n                  participation in the study or evaluation of the study results as judged by the\r\n                  investigator\r\n\r\n               -  Legal incapacity or limited legal capacity\r\n\r\n               -  Subjects who are unable to take oral medication\r\n\r\n               -  Any condition that could jeopardise the safety of the patient and their\r\n                  compliance in the study as judged by the investigator\r\n\r\n          7. History of cardiac dysfunction including one of the following:\r\n\r\n               -  Myocardial infarction by elevated cardiac enzymes or persistent regional wall\r\n                  abnormalities on assessment of LV function\r\n\r\n               -  History of documented congestive heart failure (NYHA  3)\r\n\r\n               -  Documented cardiomyopathy\r\n\r\n          8. Known HIV infection or chronic hepatitis B or C or history of hepatitis B / C\r\n\r\n          9. Active clinically relevant infection (> grade 2 NCI-CTC Version 4.03)\r\n\r\n         10. Clinical or radiological detection of CNS metastases\r\n\r\n         11. Patients receiving concomitant immunosuppressive agents or chronic use of\r\n             corticosteroids at the time of study entry except in cases outlined below:\r\n\r\n               -  topical applications (e.g. rash,) inhaled sprays, (e.g. obstructive airway\r\n                  diseases) eye drops or local injections (e.g. intraarticular) are allowed\r\n\r\n         12. Active bleeding diathesis or an oral anti-vitamin K medication (except low-dose\r\n             warfarin and aspirin or equivalent, as long as the INR  2)\r\n\r\n         13. Kidney function disorder requiring dialysis\r\n\r\n         14. Seriously impaired liver function (Child-Pugh, class C)\r\n\r\n         15. Known hypersensitivity reaction to Vinorelbine or Everolimus\r\n\r\n         16. Pregnant or breast-feeding subjects\r\n      ","sponsor":"AIO-Studien-gGmbH","sponsor_type":"Other","conditions":"Her2-negative Metastatic Breast Cancer|Her2-negative Locally Advanced Breast Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Vinorebine, Everolimus","description":"Vinorelbin: i.v. 25 mg/ m d1, d8, d15 3qw Everolimus: oral 5 mg/d d1-21 3qw until progress"},{"intervention_type":"Drug","name":"Drug: Vinorelbine","description":"Vinorelbin: i.v. 25 mg/ m d1, d8, d15 3qw until progress"}],"outcomes":[{"outcome_type":"primary","measure":"Progression-free survival (PFS)","time_frame":"Assessment over 36 months, minimum 12 month","description":"Progression-free survival (PFS) will be defined as the time from randomization to the time of disease progression or relapse or death."},{"outcome_type":"secondary","measure":"Safety and tolerability","time_frame":"Assessment over 36 months","description":"Capture all adverse events, serious adverse events, all side effects of the study medication, serious side effects, adverse events that lead to temporary or complete discontinuation of the study treatment and the Rates and causes of death.\r\nA safety interims analysis is planned, as soon as 60 subjects have finished at least two treatment cycles."},{"outcome_type":"secondary","measure":"Rate of Progression Free Survival after 6 months (6 months PFSR)","time_frame":"Assessment over 36 months","description":"descriptive Evaluation, for the monotherapy (arm 2) a median PFS of 4 months is assumed. It is expected that the combination therapy will prolong the median PFS to 6.5 months."},{"outcome_type":"secondary","measure":"Overall survival (OS)","time_frame":"36 months","description":"The duration of overall survival (OS) will be determined by measuring the time interval from randomization to the date of death or last observation."},{"outcome_type":"secondary","measure":"Response rate (CR, PR)","time_frame":"36 months","description":"The tumour status of patients will be evaluated nine weekly during the treatment until detection of progression."}]}
{"nct_id":"NCT01526109","start_date":"2012-01-31","phase":"N/A","enrollment":0,"brief_title":"Effect of Strength Training and Whole Body Vibration in Healthy Elderly","official_title":"Effect of Strength Training and Whole Body Vibration on Cognitive Function, Behavioral and Functional Capacity in Healthy Elderly.","primary_completion_date":"2015-08-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2015-12-31","last_update":"2015-12-04","description":"Quality of Life (Qol) is a complex concept which relates to the perception of subjective satisfaction, especially in elderly population. It also relates to the self-perception of psychological status, independence level, to the social relationships, and to the environment where the elderly person lives. Consequently, there are a number of factors which may change the perception of QoL, namely the occurrence of diseases, physical impairment or incapacity, and the rupture of social relationship, as well as the aging process itself. Physical exercise is associated to improvement of mental and physical health. However, few studies investigated the effect of strength training and whole- body vibration training on elderly subjects. Following this line of reasoning, the purpose of the present study is to assess the effect of physical exercise on cognition and functional abilities in elderly subjects. Design: Randomized controlled trial, double-blinded, with 12-week follow-up. Setting: Gama Filho University. Participants: Healthy Elderly. Interventions: The patients will be randomly assigned to a strength training group (STG), whole-body vibration training group (WBVG) and a control group (CG). Main outcome measures: Cognitive function will be assessed using Mini Metal State Examination (MMSE), Trail A and B, Digit Span, Stroop Test, Rey auditory-verbal learning test and Clock Test, and functional capacity will be evaluated using Senior Fitness Test, American Alliance for Health, Physical Education, Recreation & Dance(AAHPERD)functional fitness test, and Short Form 36(SF-36) health survey.","other_id":"040.2011","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":60,"maximum_age":90,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  elderly (> 60 years)\r\n\r\n          -  without diagnosis of mental illness or cognitive decline\r\n\r\n          -  literate\r\n\r\n          -  have not committed to physical exercises.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  scored outside the cutoff point set in the scales of depressive symptoms (Beck > 18)\r\n\r\n          -  cognitive decline (MSSE < 18 for low educational level and < 24 for high school).\r\n      ","sponsor":"Universidade Gama Filho","sponsor_type":"Other","conditions":"Health Behavior","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Strength training group","description":"Participants will undergo a training program set for the three functional groups, which lasted ten minutes, followed by thirty minutes of strength training twice a week consists of six exercises for major muscle groups: leg press, bench press, lat pull down, knee extension, knee flexion and Abdominal (3 sets of 10-12 repetitions at 60-80% of 1 RM with 3 min interval between sets and between workouts)."},{"intervention_type":"Behavioral","name":"Behavioral: Control group","description":"Participants will undergo a training program set for the three functional groups of ten minutes duration, followed by thirty minutes of functional exercises twice a week (2-3 sets of 30 sec. At intervals of 60 s between stimuli) carry out a range of six functional exercises combining squats and isometric or dynamic exercises for the upper limbs and trunk without intensity"},{"intervention_type":"Behavioral","name":"Behavioral: Whole-body vibration training group","description":"Participants will undergo a training program set for the three functional groups, which lasted ten minutes, followed by thirty minutes of exercise stimuli to whole-body vibration twice a week (2-3 sets of 30 sec. with frequency of stimulation at 30 Hz with 60 s intervals between stimuli), the platform will hold a range of six functional exercises combining squats and isometric or dynamic exercises for the upper limbs and trunk."}],"outcomes":[{"outcome_type":"primary","measure":"Change from baseline in Short Form 36 (SF-36) questionaire at 12 weeks","time_frame":"from date to randomization at 12 weeks","description":"The quality of life questionnaire Short Form 36 (SF-36) is multidimensional, consisting of 36 items, divided into eight scales, each scale assesses a health concept, they are: limitations in physical activities because of health problems, limitations in social activities due to physical or emotional problems, limitations in daily activities due to health problems, body pain, mental health, limitations in daily activities due to emotional problems, vitality (energy and fatigue), perception of general health."},{"outcome_type":"secondary","measure":"Change from baseline in Senior Fitness Test at 12 weeks","time_frame":"from date to randomization at 12 weeks","description":"The assessment of functional capacity of patients will be conducted through the battery functional tests of the Senior Fitness Test. Will be evaluated regarding their balance, strength, lower limb and upper, flexibility, agility, running and cardiovascular fitness. The battery consists of seven physical tests: 1) Time to Up and Go (TUG), 2) get up and down, 3) flexibility and 4) strength of MI and MS, 5) 6-minute walk, 6) sit down and test achieve, and 7) test bench."},{"outcome_type":"secondary","measure":"Change from baseline in American Alliance for Health, Physical Education, Recreation & Dance(AAHPERD)functional fitness test at 12 weeks","time_frame":"from date to randomization at 12 weeks","description":"The participant begins the test in a chair with your heels flat on the floor. At the signal of \"ready now\" moves to the right and around a cone positioned at 1.50 m and 1.80 m behind to the side of the chair, returning to his chair and sat down. Immediately the participant gets up, moves to the left and around the second cone, returning to his chair and sat down again. So complete a circuit. The individual must complete two full circuits."},{"outcome_type":"secondary","measure":"Change from baseline in Trail Making Test at 12 weeks","time_frame":"from date to randomization at 12 weeks","description":"Both parts of the Trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters. The patient should be instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper."},{"outcome_type":"secondary","measure":"Change from baseline in Mini Metal State Examination (MMSE) at 12 weeks","time_frame":"from date to randomization at 12 weeks","description":"The MMSE is a brief screening test for cognitive capabilities that evaluates orientation (spatial and time), attention, concentration, memory, calculation, language, and praxis. The score ranges from 0 to 30, with higher scores indicating better performance."},{"outcome_type":"secondary","measure":"Change from baseline in Digit Test at 12 weeks","time_frame":"from date to randomization at 12 weeks","description":"A series of number sequences are presented to the subject. In the first portion of the test, the subject is asked to reproduce the exact sequence, whereas in the second portion he/she is asked to repeat the sequence backwards. The Digit span evaluated attention, concentration and working memory."},{"outcome_type":"secondary","measure":"change from baseline in Stroop Test at 12 weeks","time_frame":"from date to randomization at 12 weeks","description":"There are three parts to the test. In Part 1, the subject must name the colors painted (blue, green, red and yellow) in a card. In Part 2, the subject reads the color names (blue, green, red and yellow) painted ignoring the printed words. In Part 3, the subject must name the color (blue, green, red and yellow) painted, ignoring the color name printed on the card, which is always different color painted."},{"outcome_type":"secondary","measure":"Change from baseline in Rey Complex Figure Test at 16 weeks","time_frame":"from date to randomization at 12 weeks","description":"It uses a complex geometric figure. The examinee is asked to copy the figure with as many details in a white paper in a horizontal position."}]}
{"nct_id":"NCT02459782","start_date":"2012-01-31","phase":"N/A","enrollment":22,"brief_title":"Ultrasound Guided Peribulbar Anaesthesia - A Novel Dual Quadrant Injection Technique","official_title":"Ultrasound Guided Peribulbar Anaesthesia: a Real-time Ultrasound Guided Technique With a Novel Dual Quadrant Injection","primary_completion_date":"2012-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-08-31","last_update":"2015-06-02","description":"Peribulbar anaesthesia for ocular surgery depends on the spread of local anaesthetic throught the orbit to be successful and has a relatively high failure rate. This study will examine a novel ultrasound guided approach to peribulbar anaesthesia which should extend the depostion of local anaesthetic by using a dual quadrant injection technique. The study will assess the feasibility of this technique, how successful it is and whether any obvious safety issues arise with its use.","other_id":"424-2011","allocation":"N/A","intervention_model":"Single Group Assignment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":90,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  ASA score less than III and ability to provide a written informed consent\r\n\r\n          -  22 patients presenting for opthalmic surgery\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Coagulation disorder or anticoagulated with INR > 1.5\r\n\r\n          -  Platelet count < 75 X 10*9/L\r\n\r\n          -  Significant Myopia (axial length > 28mm)\r\n\r\n          -  Patients unable to lie supine for 2 hours\r\n\r\n          -  Patients with recent gas or silicone injections in/around the eye\r\n      ","sponsor":"Sunnybrook Health Sciences Centre","sponsor_type":"Other","conditions":"Eye Diseases","interventions":[{"intervention_type":"Procedure","name":"Procedure: Ultrasound guided Dual Quadrant Peribulbar Anaesthesia","description":"Landmark Guided single injection vs Ultrasound guided dual quadrant injection"}],"outcomes":[{"outcome_type":"primary","measure":"Block Success","time_frame":"10 minutes post intervention","description":"Block will be deemed a failure if a supplementary block is required for the operative procedure"},{"outcome_type":"secondary","measure":"Block Quality (standardized Ocular Scoring System for akinesia and anaesthesia)","time_frame":"5 and 10 minutes","description":"Block will be assessed according to a standardized Ocular Scoring System for akinesia and anaesthesia at 5 minutes and 10 minutes post block. This is a composite measure"},{"outcome_type":"secondary","measure":"Block Volume","time_frame":"1 minute","description":"Total volume of local anaesthetic will be recorded. Volume for each part of the dual injection technique will also be recorded. This is a composite measure."},{"outcome_type":"secondary","measure":"Duration of Procedure","time_frame":"1 to 10 minutes","description":"The duration of the entire procedure will be recorded"},{"outcome_type":"secondary","measure":"Complications","time_frame":"6 Weeks","description":"Any complications during the procedure or in follow up clinical visits will be recorded"},{"outcome_type":"secondary","measure":"Image Visualization","time_frame":"1 minute","description":"Operator's ability to see the needle in both the infero-lateral and infero-medial injection will be recorded. Ability to see perineural, retrobulbar and medial rectus spread of local anaesthetic will be recorded. This is a composite qualitative measure."}]}
{"nct_id":"NCT01475214","start_date":"2012-01-31","phase":"Phase 2","enrollment":244,"brief_title":"Musculoskeletal Effects of Bicarbonate","official_title":"Musculoskeletal Benefits of Bicarbonate in Older Adults - A Dose-Finding Trial","primary_completion_date":"2014-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-08-31","last_update":"2015-10-19","description":"With aging, men and women develop a mild and progressive metabolic acidosis. This occurs as a result of declining renal function and ingestion of acid-producing diets. There is extensive evidence that severe metabolic acidosis causes bone and muscle loss, but the impact of the chronic, mild acidosis on bone and muscle in older individuals has not been established. In a recent study, administration of a single dose of bicarbonate daily for 3 months significantly reduced urinary excretion of N-telopeptide (NTX), a marker of bone resorption and urinary nitrogen, a marker of muscle wasting and improved muscle performance in the women but not the men. These and other data support a potential role for bicarbonate as a means of reducing the musculoskeletal declines that lead to extensive morbidity and mortality in the elderly. Before proceeding to a long-term bicarbonate intervention study, however, it is important to identify the dose of bicarbonate most likely to be optimal and to characterize the subjects who benefit most from it. This double blind, placebo controlled, dose-finding study will evaluate the effects of placebo and two doses of bicarbonate on urinary NTX and nitrogen excretion and on lower extremity performance over a 3 month period in 138 men and 138 women, age 60 and older. Changes in urinary excretion of NTX and nitrogen and in selected measures of lower extremity performance will be compared across the three groups. The safety and tolerability of the interventions will also be evaluated. This investigation should provide needed information on the appropriate dosing regimen for men and women and on the study population that should be enrolled in a future bicarbonate intervention trial to assess the long-term effects of this simple, low cost intervention on important clinical outcomes including rates of loss in bone and muscle mass, falls, and fractures.","other_id":"2705","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  men and women\r\n\r\n          -  age 60 and older\r\n\r\n          -  community dwelling\r\n\r\n          -  women 1 yr since last menses\r\n\r\n        Exclusion Criteria:\r\n\r\n        Medications:\r\n\r\n          1. Oral glucocorticoids for > 10 days in the last 3 months\r\n\r\n               -  Cortef (hydrocortisone)\r\n\r\n               -  Prednisone\r\n\r\n          2. Parenteral glucocorticoids\r\n\r\n              Decadron (dexamethasone)\r\n\r\n          3. Osteoporosis medications in the last 6 months\r\n\r\n               -  Forteo (teriparatide)\r\n\r\n               -  Calcimar, Miacalcin (calcitonin)\r\n\r\n               -  Evista (raloxifene)\r\n\r\n          4. Osteoporosis medications in the last 2 years\r\n\r\n               -  Fosamax (alendronate)\r\n\r\n               -  Didronel (etidronate)\r\n\r\n               -  Aredia (pamidronate)\r\n\r\n               -  Actonel (risedronate)\r\n\r\n               -  Reclast (zoledronate)\r\n\r\n          5. Tamoxifen in the last 6 months\r\n\r\n          6. Calcium/Parathyroid\r\n\r\n               -  Rocaltrol (calcitriol)\r\n\r\n               -  Zemplar (paricalcitol)\r\n\r\n               -  Drisdol, Ergocalciferol\r\n\r\n          7. Diuretics currently\r\n\r\n               -  hydrocholorothiazide (HCTZ)\r\n\r\n               -  Diuril (chlorothiazide)\r\n\r\n               -  Thalitone (chlorthalidone)\r\n\r\n               -  Zaroxolyn (metolazone)\r\n\r\n               -  Dyazide\r\n\r\n               -  Maxide\r\n\r\n               -  Moduretic\r\n\r\n               -  Lasix (forosamine)\r\n\r\n               -  Dyrenium (triamterene)\r\n\r\n               -  Midamor\r\n\r\n          8. Testosterone or estrogen in the last 6 months (vaginal estrogen okay)\r\n\r\n          9. Angiotensin converting enzyme (ACE) inhibitors currently\r\n\r\n               -  Benazepril (Lotensin)\r\n\r\n               -  Captopril (Capoten)\r\n\r\n               -  Enalapril (Vasotec)\r\n\r\n               -  Fosinopril (Monopril)\r\n\r\n               -  Lisinopril (Prinivil, Zestril)\r\n\r\n               -  Moexipril (Univasc)\r\n\r\n               -  Perindopril (Aceon)\r\n\r\n               -  Quinapril (Accupril)\r\n\r\n               -  Ramipril (Altace)\r\n\r\n               -  Trandolapril (Mavik)\r\n\r\n         10. Angiotensin II receptor blockers currently\r\n\r\n               -  Candesartan (Atacand)\r\n\r\n               -  Eprosartan (Teveten)\r\n\r\n               -  Irbesartan (Avapro)\r\n\r\n               -  Losartan (Cozaar)\r\n\r\n               -  Olmesartan (Benicar)\r\n\r\n               -  Telmisartan (Micardis)\r\n\r\n               -  Valsartan (Diovan)\r\n\r\n        Over-the-Counter Drugs currently\r\n\r\n          1. Antacids - any antacid that contains calcium carbonate, aluminum hydroxide, magnesium\r\n             hydroxide, or calcium acetate - selected examples include\r\n\r\n               -  TUMS\r\n\r\n               -  Mylanta\r\n\r\n               -  Maalox\r\n\r\n               -  Titralac\r\n\r\n               -  Rolaids\r\n\r\n               -  Sodium bicarbonate (baking soda)\r\n\r\n               -  Note: magaldrate or Riopan is allowed\r\n\r\n          2. Potassium supplements\r\n\r\n          3. Salt substitutes\r\n\r\n        Conditions/Diseases\r\n\r\n          1. renal disease including kidney stones in the past 5 years or glomerular filtration\r\n             rate (GFR) < 60 ml/min/1.73 m2\r\n\r\n          2. hyperkalemia (serum potassium >5.3 meq/L; normal range 3.5-5.3 meq/L)\r\n\r\n          3. elevated serum bicarbonate (serum bicarbonate > 29 mmol/L; normal range 22-29 mmol/L)\r\n\r\n          4. cirrhosis\r\n\r\n          5. gastroesophageal reflux disease (GERD) requiring treatment with alkali-containing\r\n             antacids (TUMS, Mylanta, Maalox, Titralac, Rolaids, or sodium bicarbonate)\r\n\r\n          6. hyperparathyroidism\r\n\r\n          7. untreated thyroid disease\r\n\r\n          8. significant immune disorder such as rheumatoid arthritis\r\n\r\n          9. current unstable heart disease\r\n\r\n         10. active malignancy or cancer therapy in the last year\r\n\r\n         11. fasting spot urine calcium/creatinine > 0.38 mmol/mmol after 1 wk off of calcium\r\n             supplements\r\n\r\n         12. congestive heart failure, arrhythmias (surgically treated arrhythmias acceptable), or\r\n             myocardial infarction in last 12 months\r\n\r\n         13. serum calcium outside the normal range of 8.3-10.2 mg/dl\r\n\r\n         14. uncontrolled diabetes mellitus (fasting blood sugar > 130)\r\n\r\n         15. alcohol use exceeding 2 drinks/day\r\n\r\n         16. peptic ulcers or esophageal stricture\r\n\r\n         17. weight <45 or >113.5 kg (<99 or >249.7 lbs)\r\n\r\n         18. other abnormalities in screening labs, at discretion of the study physician (the PI)\r\n      ","sponsor":"Tufts University","sponsor_type":"Other","conditions":"Muscle Loss|Fractures|Osteoporosis, Age Related|Fall Injury","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: potassium bicarbonate","description":"potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: potassium bicarbonate","description":"potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water"},{"intervention_type":"Other","name":"Other: Inactive placebo capsule","description":"microcrystalline cellulose"}],"outcomes":[{"outcome_type":"primary","measure":"The Dose of Potassium Bicarbonate Needed for Maximal Suppression of 24-hr Urinary N-telopeptide","time_frame":"84 days","description":"Describe and compare changes in urinary N-telopeptide (NTX) across the placebo and Potassium Bicarbonate (KHCO3) doses."},{"outcome_type":"primary","measure":"Co-primary Aim - to Identify the Dose of KHCO3 Needed for Maximal Suppression of 24-hr Urinary Nitrogen","time_frame":"84 days","description":"Describe and compare changes in 24-hour urinary nitrogen in the low and high dose and KHCO3 group and in placebo."}]}
{"nct_id":"NCT01543984","start_date":"2012-01-31","phase":"Phase 1/Phase 2","enrollment":54,"brief_title":"Efficacy of \"Tailored Physical Activity\" in Health Care Workers","official_title":"Efficacy of \"Tailored Physical Activity\" on the Number of Sick Days: a Randomized Controlled Trial in Health Care Workers That Have Experienced Pain Related to the Spine or Upper Body","primary_completion_date":"2013-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-04-30","last_update":"2015-11-20","description":"The purpose of this study is to test the effect of \"Tailored Physical Activity\" on the number of sick-days. The hypothesis is that \"Tailored Physical Activity\" is superior in efficacy on sick-days.","other_id":"95-154-32028T","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Health care workers in municipality of Snderborg that have experienced musculoskeletal\r\n        pain related to the spine or upper body.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Medically safety.\r\n      ","sponsor":"University of Southern Denmark","sponsor_type":"Other","conditions":"Pain","interventions":[{"intervention_type":"Other","name":"Other: Tailored Physical Activity","description":"Tailored Physical Activity (3*50 min/week in 10 weeks)"},{"intervention_type":"Behavioral","name":"Behavioral: Health Counselling","description":"Health guidance (1,5h)"}],"outcomes":[{"outcome_type":"primary","measure":"Self-reported number of sick-days","time_frame":"3 months","description":"\"How many days have you in total been on sick leave because of musculoskeletal troubles (such as ache, pain, discomfort)during the last three months\" ((0 days, 1-7 days, 8-30 days, 30 days)."},{"outcome_type":"secondary","measure":"Aerobic capacity","time_frame":"3 months"},{"outcome_type":"secondary","measure":"Hand-grip strength","time_frame":"3 months"},{"outcome_type":"secondary","measure":"Body weight, waist circumference, hip circumference","time_frame":"3 months"},{"outcome_type":"secondary","measure":"Questionnaire","time_frame":"3 months"},{"outcome_type":"secondary","measure":"Self-reported number of sick-days","time_frame":"12 months follow-up","description":"\"How many days have you in total been on sick leave because of musculoskeletal troubles (such as ache, pain, discomfort)during the last three months\" ((0 days, 1-7 days, 8-30 days, 30 days)."},{"outcome_type":"secondary","measure":"Aerobic capacity","time_frame":"12 months follow-up"},{"outcome_type":"secondary","measure":"Hand-grip strength","time_frame":"12- months follow-up"},{"outcome_type":"secondary","measure":"Body weight, waist circumference, hip circumference","time_frame":"12 months follow-up"},{"outcome_type":"secondary","measure":"Questionnaire","time_frame":"12 months follow-up"}]}
{"nct_id":"NCT01745445","start_date":"2012-01-31","phase":"Phase 2","enrollment":30,"brief_title":"Clinical Randomized Study of Concurrent Chemo-radiotherapy vs Radiotherapy Alone to Local-advanced Small Cell Lung Cancer (SCLC)","official_title":"Phase Clinical Trial of Randomized Concurrent Chemoradiotherapy or Radiotherapy Alone for Local-advanced Small Cell Lung Cancer After Induced Chemotherapy","primary_completion_date":"2016-11-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2016-12-31","last_update":"2016-05-17","description":"This trial aims to evaluate the efficacy and safety between radiotherapy alone and concurrent chemo-radiotherapy after 3-4 cycles of chemotherapy in LS-SCLC.","other_id":"CIH-PQS-201205001","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":17,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Age 18- 75 years; ECOG performance status 0 or 1; Pathological or cytological confirmation\r\n        of SCLC; Local stage small cell lung cancer with stage a and b; Receive 3-4 cycles of\r\n        chemotherapy with etoposide plus cisplatin; Measurable disease using RECIST criteria with\r\n        at least one lesion;\r\n\r\n        Adequate hematological, renal, hepatic and pulmonary functions defined as:\r\n\r\n        granulocytes  2.0109/L, platelets  100 x 109/L, hemoglobin  8g/L, total bilirubin  1.5\r\n        x upper normal limit, aspartate aminotransferase, alanine aminotransferase2.5  upper\r\n        normal limit,, creatinine  1.5mg/L, FEV1  1.5 L Ability to understand and willingness to\r\n        sign a written informed consent form;\r\n\r\n        Exclusion Criteria:\r\n\r\n        History of operation of lung cancer; PD after 3-4 cycles chemotherapy; Patients with sever\r\n        infection; Patients with uncontrollable diabetes; Patients in pregnancy or lactation;\r\n        Patients who are currently receiving or have received other clinical trail for\r\n        radioprotection within the prior six months are excluded; Patient with history of\r\n        malignancy other than skin cancer or Carcinoma in-situ within 2 years; History of\r\n        cardiovascular diseases that might include one of the following: myocardial infraction,\r\n        angina, coronary angioplasty, congestive heart failure, stroke, or coronary bypass surgery\r\n        in the last 6 months; Concomitant treatment with other anticancer drugs;\r\n      ","sponsor":"Tianjin Medical University Cancer Institute and Hospital","sponsor_type":"Other","conditions":"Small Cell Lung Cancer","interventions":[{"intervention_type":"Other","name":"Other: concurrent chemo-radiotherapy arm","description":"VP-16 50 mg/m2 on day 1-5 and Carboplatin AUC = 5 on day 1 will be given by intravenous infusion for 3-4 cycles. Then a total dose of 60 Gy will be given in 30 fractions of 2 Gy, 5 fractions per week; Starting the first cycle of concurrent chemotherapy at the first day of radiotherapy. The chemotherapeutic scheme is intravenous infusion of Cisplatin 25mg/m2 on day 1-3 and oral administration of Etoposide 100mg on day1-5 and 3 weeks as a cycle for 2 consecutive cycles."}],"outcomes":[{"outcome_type":"primary","measure":"disease free survival","time_frame":"3 years","description":"DFS was defined as the length of time from the date of randomization to the date of first documentation of relapse of SCLC or any other type of cancer or death."},{"outcome_type":"secondary","measure":"overall survival","time_frame":"3 years","description":"OS was defined as the length of time from the date of randomization to the date of death of various reasons."},{"outcome_type":"secondary","measure":"acute and late toxic effects","time_frame":"3 months and 3 years","description":"acute toxic effect was defined as toxic effects less than 90 days from initiation of treatment late toxic effect was defined as toxic effects more than 90 days from initiation of treatment"}]}
{"nct_id":"NCT01420640","start_date":"2012-01-31","phase":"N/A","enrollment":224,"brief_title":"Tai Chi and Aerobic Exercise for Fibromyalgia (FMEx)","official_title":"Tai Chi and Aerobic Exercise for Fibromyalgia","primary_completion_date":"2015-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-11-30","last_update":"2016-02-10","description":"The investigators will conduct a large randomized controlled trial comparing the effectiveness of Tai Chi mind-body exercise and standard-of-care aerobic exercise for fibromyalgia. In addition, the investigators will determine the optimal frequency and duration of a Tai Chi intervention for short and long-term effectiveness.","other_id":"1R01AT006367-01A1","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":21,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age 21 years or older.\r\n\r\n          -  Fulfills the American College of Rheumatology (ACR) 1990 classification criteria for\r\n             FM: (1) a history of widespread musculoskeletal pain on the right and left sides of\r\n             the body as well as above and below the waist for a minimum duration of 3 months, and\r\n             (2) pain in 11 or more of 18 specific tender points with moderate or greater\r\n             tenderness reported upon digital palpation.27\r\n\r\n          -  Fulfills the ACR 2010 diagnostic criteria for FM: (WPI 7 AND SS 5) OR (WPI 3-6 AND\r\n             SS 9) and does not have a disorder that would otherwise explain the pain28\r\n\r\n          -  Willing to complete the 12-week or 24-week study, including once or twice-a-week\r\n             exercise sessions.\r\n\r\n          -  Willing to abstain from Tai Chi or other new formalized exercise programs until\r\n             completion of the study if randomized to the Aerobic Exercise.\r\n\r\n          -  Willing to abstain from Aerobic Exercise or other new formalized exercise programs\r\n             until completion of the study if randomized to Tai Chi\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior experience with Tai Chi or other similar types of Complementary and Alternative\r\n             Medicine in the past 1 year such as Qi gong and yoga since these share some of the\r\n             principles of Tai Chi.\r\n\r\n          -  Dementia, neurological disease, cancer, cardiovascular disease, pulmonary disease,\r\n             metabolic disease, renal disease, liver disease, or other serious medical conditions\r\n             limiting ability to participate in the Tai Chi or Aerobic Exercise programs, as\r\n             determined by the study physicians.\r\n\r\n          -  Any other diagnosed medical condition known to contribute to FM symptomatology that is\r\n             not under adequate control for the study period such as thyroid disease, inflammatory\r\n             arthritis, systemic lupus erythematosus, rheumatoid arthritis, myositis, vasculitis or\r\n             Sjogren's syndrome.\r\n\r\n          -  Inability to pass the Mini-Mental Status examination (with a score below 24) 29\r\n\r\n          -  Enrollment in any other clinical trial within the last 30 days\r\n\r\n          -  Plan to permanently relocate from the region during the trial period\r\n\r\n          -  Positive urine pregnancy test at baseline or planning pregnancy within the study\r\n             period\r\n\r\n          -  Not English-Speaking: English is the only language to be used during the exercise\r\n             training program. Our self-reported outcome measures are obtained from validated\r\n             English-version questionnaires. In addition, using other languages would likely\r\n             require separate classes, recruitment and instructors which are beyond our current\r\n             study scope\r\n      ","sponsor":"Tufts Medical Center","sponsor_type":"Other","conditions":"Fibromyalgia","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Lower frequency, shorter period of Tai Chi","description":"12 weeks of supervised Tai Chi classes, 1x/week"},{"intervention_type":"Behavioral","name":"Behavioral: Higher frequency, shorter period of Tai Chi","description":"12 weeks of supervised Tai Chi classes, 2x/week"},{"intervention_type":"Behavioral","name":"Behavioral: Shorter frequency, longer period of Tai Chi","description":"24 weeks of supervised Tai Chi classes, 1x/week"},{"intervention_type":"Behavioral","name":"Behavioral: Higher frequency, longer period of Tai Chi","description":"24 weeks of supervised Tai Chi classes, 2x/week"},{"intervention_type":"Behavioral","name":"Behavioral: Aerobic Exercise Training","description":"24 weeks of supervised aerobic exercise training, 2x/week"}],"outcomes":[{"outcome_type":"primary","measure":"Change in Fibromyalgia Impact Questionnaire (FIQ) from baseline to 24 weeks","time_frame":"Week 0, Week 24","description":"Overall severity of FM, intensity of pain, physical function, fatigue, morning tiredness, depression, anxiety, job difficulty, and overall well-being"},{"outcome_type":"secondary","measure":"Change in Fibromyalgia Impact Questionnaire at follow-up","time_frame":"Week 0, Week 12, Week 52","description":"Overall severity of FM, intensity of pain, physical function, fatigue, morning tiredness, depression, anxiety, job difficulty, and overall well-being"},{"outcome_type":"secondary","measure":"FM Symptom Severity Scale","time_frame":"Week 0, Week 12, Week 24, Week 52","description":"FM symptoms"},{"outcome_type":"secondary","measure":"Body Mass Index (BMI)","time_frame":"Week 0, Week 12, Week 24, Week 52","description":"General health"},{"outcome_type":"secondary","measure":"Medical Outcome Study Short Form 36 (SF-36)","time_frame":"Week 0, Week 12, Week 24, Week 52","description":"General health/functional status"},{"outcome_type":"secondary","measure":"Patient Global Assessment","time_frame":"Week 0, Week 12, Week 24, Week 52","description":"General health/functional status"},{"outcome_type":"secondary","measure":"The Beck Depression Inventory II","time_frame":"Week 0, Week 12, Week 24, Week 52","description":"Depression"},{"outcome_type":"secondary","measure":"The Chronic Pain Self-Efficacy Scale (CPSS)","time_frame":"Week 0, Week 12, Week 24, Week 52","description":"Chronic pain"},{"outcome_type":"secondary","measure":"The Pittsburg Sleep Quality Index (PSQI)","time_frame":"Week 0, Week 12, Week 24, Week 52","description":"Sleep quality"},{"outcome_type":"secondary","measure":"The Sleep Quality Numeric Rating Scale (NRS)","time_frame":"Week 0, Week 12, Week 24, Week 52","description":"Sleep quality"},{"outcome_type":"secondary","measure":"6-Minute Walk","time_frame":"Week 0, Week 12, Week 24, Week 52","description":"Walking ability and Endurance"},{"outcome_type":"secondary","measure":"The Chair Stand Test","time_frame":"Week 0, Week 12, Week 24, Week 52","description":"Physical functioning"},{"outcome_type":"secondary","measure":"The brief Outcome Expectation Scale (OES)","time_frame":"Week 0, Week 12, Week 24, Week 52","description":"Outcome expectations"},{"outcome_type":"secondary","measure":"Health Assessment Questionnaire (HAQ)","time_frame":"Week 0, Week 12, Week 24, Week 52","description":"Healthcare cost and utilization"},{"outcome_type":"secondary","measure":"PROMIS Health Assessment Questionnaire (HAQ)","time_frame":"Week 0, Week 12, Week 24, Week 52","description":"Health status"},{"outcome_type":"secondary","measure":"Muscle Strength/Power and Balance","time_frame":"Week 0, Week 12, Week 24, Week 52","description":"Physical functioning as assessed by muscle strength and power, and balance"},{"outcome_type":"secondary","measure":"CHAMPS Activities Questionnaire for Older Adults","time_frame":"Week 0, Week 12, Week 24, Week 52","description":"Activity levels"}]}
{"nct_id":"NCT01650662","start_date":"2012-01-31","phase":"Phase 3","enrollment":410,"brief_title":"CYCLosporinE A in Reperfused Acute Myocardial Infarction","official_title":"CYCLosporinE A in Reperfused Acute Myocardial Infarction Prospective, Controlled, Randomized, Multicentre Trial to Examine Whether a Single i.v. Bolus of Cyclosporine A Before PCI Can Reduce Myocardial Reperfusion Injury in Patients With STEMI.","primary_completion_date":"2014-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-10-31","last_update":"2015-04-16","description":"Infarct size is a major determinant of prognosis after myocardial infarction (MI). It has been reported that Cyclosporine A (CsA) administered immediately prior to percutaneous coronary intervention (PCI) significantly could reduce reperfusion injury and consequently infarct size in ST elevation MI (STEMI) patients. CYCLE trial is a multicenter, controlled, randomized open label study, with blind assessment of endpoint measures. The objective is to determine whether a single i.v. dose of CsA within 6 hour onset of symptoms of STEMI in 444 patients, improves outcomes after successful primary PCI, by reducing myocardial injury associated to reperfusion.","other_id":"CYCLE (IRFMN_5635)","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male and female patients with large STEMI not older than 6 hours, defined as\r\n\r\n          -  angina pectoris or equivalent symptoms of more than 20 minutes duration within last 6\r\n             hours, and\r\n\r\n          -  ST elevation in at least 3 leads in anterior MI and/or a deviation in at least 4 leads\r\n             in inferior MI,\r\n\r\n          -  TIMI flow 0 or 1 in identified culprit artery\r\n\r\n          -  Intended acute primary PCI\r\n\r\n          -  Age  18 years\r\n\r\n          -  Ability to understand the nature, scope, and possible consequences of the study\r\n             participation/legal capacity\r\n\r\n          -  Written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Left bundle branch block\r\n\r\n          -  TIMI flow > 1 in the identified culprit artery\r\n\r\n          -  Treatment with CsA within last 10 days\r\n\r\n          -  Contraindication to CsA or history of allergic reaction to CsA\r\n\r\n          -  Coronary anatomy not suitable for PCI\r\n\r\n          -  Thrombolytic therapy within 24 h. before randomization\r\n\r\n          -  Previous MI\r\n\r\n          -  Previous CABG\r\n\r\n          -  Severe renal or hepatic insufficiency\r\n\r\n          -  Malignant tumor, not curatively treated\r\n\r\n          -  Women with childbearing potential, esp. pregnant or nursing women\r\n\r\n          -  Participation in another clinical or device trial within the previous 30 days\r\n      ","sponsor":"Mario Negri Institute for Pharmacological Research","sponsor_type":"Other","conditions":"Acute Myocardial Infarction","interventions":[{"intervention_type":"Drug","name":"Drug: Cyclosporine A","description":"In the CsA group, at least 5 min before balloon inflation and stenting, patients will receive an intravenous bolus injection of 2.5 mg/kg of CsA. In the control group, patients will receive only recommended treatments. CsA will be dissolved in normal NaCl 0.9% solution (final concentration 25 mg/ml) and injected slowly (over 20-30 seconds) via a catheter positioned in an antecubital vein at least 5 min before PCI, to allow for distribution of the drug."}],"outcomes":[{"outcome_type":"primary","measure":"Improvement of myocardial reperfusion, measured with ST-segment resolution >=70%","time_frame":"1 hour after percutaneous coronary intervention (PCI)","description":"Improvement of myocardial reperfusion, measured with ST-segment resolution >=70% 1 hour after PCI"},{"outcome_type":"secondary","measure":"High sensitive cardiac troponin T (hs-cTnt).","time_frame":"at day 4 after percutaneous coronary intervention (PCI)","description":"High sensitive cardiac troponin T (hs-cTnt) at day 4 after PCI; ; this will be the most relevant among secondary endpoints given its value as readout of cardiac protection."},{"outcome_type":"secondary","measure":"Clinical events: all-cause mortality, HF or shock; rehospitalization for CV reasons","time_frame":"within 6 months of randomization","description":"Clinical events within 6 months of randomization: all-cause mortality, HF or shock; rehospitalization for CV reasons."},{"outcome_type":"secondary","measure":"Infarct size: Troponin curve (T or I, assayed locally)","time_frame":"Time course of troponin release during the first 72 hours after the visualization of the antegrade flow.","description":"Infarct size: Troponin curve (T or I, assayed locally); The time course of troponin release during the first 72 hours after the visualization of the antegrade flow, will be studied."},{"outcome_type":"secondary","measure":"LV remodeling and function as assessed by echocardiography;","time_frame":"at 6 months after randomization","description":"LV remodeling and function at 6 months, as assessed by echocardiography;"},{"outcome_type":"secondary","measure":"No reflow, as assessed by myocardial blush","time_frame":"1 day (after the visualization of the antegrade flow)","description":"No reflow, as assessed by myocardial blush after the visualization of the antegrade flow"}]}
{"nct_id":"NCT02661802","start_date":"2012-01-31","phase":"N/A","enrollment":30,"brief_title":"Effects Oxygen Supplementation Determined Better Exercise Capacity in Eisenmenger Syndrome","official_title":"Acute Effects of 40% Oxygen Supplementation Determined Better Exercise Capacity in Eisenmenger Syndrome","primary_completion_date":"2014-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-06-30","last_update":"2016-01-25","description":"The purpose of this study was to evaluate the acute effects of oxygen supplementation during a submaximal exercise test in patients with Eisenmenger's Syndrome.","other_id":"13473813.1.0000.5505","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Abscence of heart failure and/or respiratory infection\r\n\r\n          -  Advanced therapy for pulmonary hypertension\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Lung, liver or connective tissue diseases\r\n\r\n          -  Neuromuscular diseases\r\n\r\n          -  Inability to perform a pulmonary function test and/or chronic lung disease\r\n\r\n          -  Inability to walk\r\n      ","sponsor":"Federal University of So Paulo","sponsor_type":"Other","conditions":"Eisenmenger Complex|Hypertension, Pulmonary","interventions":[{"intervention_type":"Other","name":"Other: Oxygen Supplementation","description":"Oxygen delivery was continuous by mask at 40%"}],"outcomes":[{"outcome_type":"primary","measure":"Distance walked during the six-minute walk tests","time_frame":"At enrollment","description":"Distance walked during the six-minute walk tests with and without oxygen supplementation were recorded and compared to each other to establish the impact of the intervention."}]}
{"nct_id":"NCT01522287","start_date":"2012-01-31","phase":"Phase 1","enrollment":88,"brief_title":"Computer Assisted Cognitive Behavior Therapy for Obsessive Compulsive Disorder: A Comprehensive Stepped-Care Approach","official_title":"Computer Assisted CBT for OCD: A Comprehensive Stepped-Care Approach","primary_completion_date":"2013-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-12-31","last_update":"2014-03-14","description":"The goal of this project is to improve access to effective treatments for obsessive compulsive disorder (OCD) through the use of web-based cognitive behavioral therapy (CBT) treatment. There intervention involves both a computer program (BT Steps) and human interaction via telephone. The investigators will test the efficacy and feasibility of computer therapy alone (n=35), computer plus a non-therapist coach (n=35), and computer plus a CBT therapist coach (n=35","other_id":"R43MH090612","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age 18 or above\r\n\r\n          -  Have clinically significant OCD\r\n\r\n          -  YBOCS score of 16-32\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Significant comorbid depression\r\n\r\n          -  Serious suicide risk\r\n\r\n          -  Psychosis or psychotic disorder\r\n      ","sponsor":"Center for Psychological Consultation","sponsor_type":"Other","conditions":"Obsessive Compulsive Disorder","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Computer-Assisted Cognitive Behavior Therapy (BT STEPS)","description":"BT STEPS is a computer-assisted self help treatment for OCD. Clients work through the program at their own pace."}],"outcomes":[{"outcome_type":"primary","measure":"Yale Brown Obsessive Compulsive Scale (YBOCS)","time_frame":"Change from Baseline on YBOCS at 12 weeks","description":"YBOCS measures severity of obsessions and compulsions"},{"outcome_type":"secondary","measure":"PHQ-9","time_frame":"Change from baseline on PHQ9 at 12 weeks","description":"PHQ-9 assesses the 9 core DSM symptoms of depression"},{"outcome_type":"secondary","measure":"Work and Social Adjustment Scale (WSA)","time_frame":"Change from baseline on WSA at 12 weeks","description":"Measures problems at work and social relationships"}]}
{"nct_id":"NCT01534962","start_date":"2012-01-31","phase":"Phase 2","enrollment":241,"brief_title":"Ranolazine in Atrial Fibrillation Following An ELectricaL CardiOversion","official_title":"A Randomised, Double-blind, Double-dummy, Placebo-controlled, Dose-ranging Phase II Study Assessing Ranolazine in the Maintenance of Sinus Rhythm After Electrical Cardioversion in Patients With Non-permanent Atrial Fibrillation.","primary_completion_date":"2013-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-03-31","last_update":"2014-08-19","description":"Dose-ranging Phase II study testing the efficacy and safety of 3 doses of Ranolazine (low, intermediate and high, given BID) versus placebo in maintaining sinus rhythm after successful electrical cardioversion in patients with persistent atrial fibrillation (AFib). After successful cardioversion and subsequent randomisation, patients report trans-telephonic EGCs on a daily basis to a central core ECG facility. Maximum treatment duration is 112 days (16 weeks).","other_id":"RAF-01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female patients 18 years and older\r\n\r\n          -  Patients with persistent AF suitable for electrical direct current cardioversion (DCC)\r\n\r\n          -  A female of childbearing potential may be enrolled providing she has a negative\r\n             pregnancy test at baseline and is routinely using an effective method of birth control\r\n             resulting in a low failure rate until end of study\r\n\r\n          -  Able to give written informed consent before any study related procedure\r\n\r\n          -  Able to attend all the visits scheduled in the study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with first diagnosed AF or patients with paroxysmal AF\r\n\r\n          -  Patients with long-standing persistent AF or permanent AF\r\n\r\n          -  Patients having known concurrent temporary secondary causes of AF such as alcohol\r\n             intoxication, pulmonary embolism, hyperthyroidism, pneumonia, hypoxemia, acute\r\n             pericarditis or myocarditis\r\n\r\n          -  Patients having undergone atrial catheter ablation for AF\r\n\r\n          -  Patients carrying a pacemaker\r\n\r\n          -  Patients with electrolytes imbalances that may cause cardiac arrhythmias, e.g.\r\n             potassium < 3.5 mmol/L or > 5.5 mmol/L\r\n\r\n          -  Patients with any contra-indications to Ranexa according to the drug-specific product\r\n             characteristics\r\n\r\n          -  Patients taking class I or Class III antiarrhythmic agents within 3 days of planned\r\n             randomisation\r\n\r\n          -  Patients taking beta-blockers unless used on stable doses for at least 2 weeks prior\r\n             to the planned randomisation. Single doses of Intravenous beta-blockers are allowed up\r\n             to 10 hours from the planned randomisation\r\n\r\n          -  Patients taking Dronedarone or oral Amiodarone within 2 weeks and 3 months of planned\r\n             randomisation, respectively\r\n\r\n          -  Patients with a history of ECG abnormalities that in the opinion of the Investigator\r\n             render the subject unsuitable for the trial, including history of congenital or a\r\n             family history of long QT syndrome and a QTc interval 500 msec at Screening\r\n\r\n          -  Patients with congestive heart failure NYHA grade III and IV;\r\n\r\n          -  Patients with any serious intercurrent illness (including psychiatric and neurological\r\n             disorders) which, in the opinion of the Investigator, is incompatible with the\r\n             protocol.\r\n\r\n          -  Patients taking Metformin at a total daily dose greater than 1000 mg.\r\n\r\n          -  Patients taking Simvastatin at a total daily dose greater than 20 mg.\r\n      ","sponsor":"Menarini Group","sponsor_type":"Industry","conditions":"Persistent Atrial Fibrillation","interventions":[{"intervention_type":"Drug","name":"Drug: Ranolazine","description":"Oral administration, BID; for a maximum of 112 days."},{"intervention_type":"Drug","name":"Drug: Ranolazine","description":"Oral administration, BID; for a maximum of 112 days."},{"intervention_type":"Drug","name":"Drug: Ranolazine","description":"Oral administration, BID; for a maximum of 112 days."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Oral administration, BID; for a maximum of 112 days."}],"outcomes":[{"outcome_type":"secondary","measure":"Time From Randomization to First Documented AF Recurrence in Patients With Sinus Rhythm 48 Hours After Cardioversion","time_frame":"16 weeks (112 days)","description":"Excluding patients with early relapses (within 48 hours) while the study drug, started after cardioversion, had not yet reached steady-state."},{"outcome_type":"primary","measure":"Time From Randomization to First Documented AF Recurrence.","time_frame":"16 weeks (112 days)","description":"Time to first AF recurrence reported by patient-reported TT-ECG or 12-Lead ECG at the study site, whichever occurred first.\r\nPatients discontinuing the study without AF were censored at the time of the last available ECG."},{"outcome_type":"secondary","measure":"Number of Patients With Documented AF Recurrences","time_frame":"16 weeks (112 days)"},{"outcome_type":"secondary","measure":"Time From Randomization to First Documented and Confirmed AF Recurrence","time_frame":"16 weeks (112 days)","description":"A confirmed AF recurrence was defined as a documented AF recurrence which was confirmed by a consecutive ECG performed at least 1 hour after first AF documentation."},{"outcome_type":"secondary","measure":"Number of Patients With Documented and Confirmed AF Recurrences","time_frame":"16 weeks (112 days)"},{"outcome_type":"secondary","measure":"Number of Patients in Sinus Rhythm 48 Hours After Cardioversion With Documented AF Recurrence","time_frame":"16 weeks (112 days)","description":"Documented AF recurrences in those patients who did not experience early relapses (within 48 hours after cardioversion)"}]}
{"nct_id":"NCT02004561","start_date":"2012-01-31","enrollment":26,"brief_title":"Comparison Between Gastric Band, Laparoscopic Sleeve Gastrectomy, Gastric Bypass Surgeries","official_title":"Outcomes Comparison Between Gastric Band, Laparoscopic Sleeve Gastrectomy, and Gastric Bypass Surgeries in Obese Adolescents","primary_completion_date":"2025-02-28","study_type":"Observational [Patient Registry]","rec_status":"Active, not recruiting","completion_date":"2025-02-28","last_update":"2021-04-21","description":"Determine the short and long term safety and efficacy of the Gastric bypass , laparoscopic sleeve gastrectomy, and Gastric banding (LAGB) on severely obese adolescents. The procedure selection is made by the patient or patient and guardian. This is not a randomized trial.","other_id":"1109009034","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":14,"maximum_age":19,"population":"The research subjects will be recruited from the Yale Pediatric Obesity Clinic and the\r\n        Endocrine Clinic.","criteria":"\n        Inclusion Criteria:\r\n\r\n        Youth 14-19yrs\r\n\r\n          -  6 months of attempts at weight management by primary care physician or Pediatric\r\n             Endocrinologist\r\n\r\n          -  Approval by the Adolescent Bariatric Surgery clinic to undergo surgery\r\n\r\n          -  Physically or nearly physically mature\r\n\r\n          -  BMI >= 35kg/m2 with one obesity related comorbidities or BMI >= 40 kg/m2\r\n\r\n          -  Commitment to avoid pregnancy for at least 1 year postoperatively\r\n\r\n          -  Capability and willingness to adhere to nutritional guidelines postoperatively\r\n\r\n          -  Informed consent to surgical treatment\r\n\r\n          -  Demonstration of decisional capacity\r\n\r\n          -  Supportive family environment\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Inability to be approved by Yale Adolescent Bariatric Surgery clinic to undergo\r\n             surgery\r\n\r\n          -  Uncontrolled psychosis\r\n\r\n          -  Uncontrolled depression\r\n\r\n          -  Drug or alcohol abuse\r\n\r\n          -  History of congenital or acquired anomalies of gastrointestinal tract\r\n\r\n          -  Esophageal anatomical abnormality or dysmotility\r\n\r\n          -  Inflammatory bowel disease\r\n\r\n          -  Severe cardiopulmonary disease\r\n\r\n          -  Severe coagulopathy\r\n\r\n          -  Hepatic insufficiency or cirrhosis\r\n\r\n          -  Presence of localized or systemic infection at time of surgery\r\n\r\n          -  Obesity related to central causes: Prader Willi and hypothalamic abnormalities\r\n\r\n          -  Non-compliance to nutrition plan, exercise, and behavioral counseling/treatment\r\n\r\n          -  Pregnant, breast-feeding or planning of becoming pregnant within 1-2 years of surgery\r\n      ","sponsor":"Yale University","sponsor_type":"Other","conditions":"Obese Adolescents","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Change in Glucose Tolerance","time_frame":"baseline, 2 month, 3 month, 12 month","description":"Glucose tolerance changes measured by 3 hour oral glucose tolerance test."},{"outcome_type":"secondary","measure":"Change in Anthropometric data","time_frame":"Baseline, 2 weeks, 2 mnths, 3 months, 6 months, 12 months, 24 months","description":"Height, weight, body fat percentage changes"},{"outcome_type":"secondary","measure":"Changes in nutritional health","time_frame":"Baseline, 2 weeks, 2 mnths, 3 months, 6 months, 12 months, 24 months","description":"Changes in vitamin/mineral blood levels"},{"outcome_type":"other","measure":"Fat distribution","time_frame":"baseline, 2 weeks, 2 months, 3 months, 6 months, 12 months, 24 months","description":"Abdominal MRI"}]}
{"nct_id":"NCT02222220","start_date":"2012-01-31","phase":"Phase 3","enrollment":61,"brief_title":"Metoclopramide as Treatment of Clozapine-induced Hypersalivation","official_title":"Metoclopramide as Treatment of Clozapine-induced Hypersalivation","primary_completion_date":"2014-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-05-31","last_update":"2014-08-21","description":"Hypersalivation (sialorrhea or ptyalism) is known as a frequent, disturbing, uncomfortable adverse effect of clozapine therapy that can lead to noncompliance. Until now there is no effective enough treatment for this side effect. Previous studies demonstrated that different medications from the substitute benzamide derivatives group: amisulpride, sulpiride (higher selective binding to the D2/D3 dopamine receptor) and moclobemide (reversible inhibitor of monoamine oxidase A, which inhibits the deamination of serotonin, norepinephrine and dopamine) may be effective as a treatment of clozapine-induced hypersalivation (CIH). Moreover, there is another substitute benzamide derivative: metoclopramide (dopamine D2 antagonist, usually used as antiemetic medication in general medicine). The investigators hypothesis assumes that anti-salivation effect characterizes the whole group of benzamide. The aim of this study was to examine the efficacy of metoclopramide as an optional possibility for management of CIH.","other_id":"VLAK-14","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":19,"maximum_age":57,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age 18-60 years, male or female\r\n\r\n          -  DSM-IV criteria for schizophrenia\r\n\r\n          -  Clozapine treatment\r\n\r\n          -  At least score >2 on the Nocturnal Hypersalivation Rating Scale (NHRS)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Evidence of organic brain damage, mental retardation, alcohol or drug abuse\r\n\r\n          -  Patients suffering from pheochromocytoma\r\n\r\n          -  Patients suffering from Parkinson's disease\r\n      ","sponsor":"Beersheva Mental Health Center","sponsor_type":"Other","conditions":"Clozapine-induced Hypersalivation","interventions":[{"intervention_type":"Drug","name":"Drug: Metoclopramide","description":"30 mg/day during 4 weeks"},{"intervention_type":"Drug","name":"Drug: placebo"}],"outcomes":[{"outcome_type":"secondary","measure":"Drooling Severity Scale (DSS)","time_frame":"every week, up to 4 weeks"},{"outcome_type":"primary","measure":"Nocturnal Hypersalivation Rating Scale (NHRS)","time_frame":"every week, up to 4 weeks"},{"outcome_type":"other","measure":"The Positive and Negative Syndrome Scale (PANSS)","time_frame":"every week, up to 4 weeks"}]}
{"nct_id":"NCT02388841","start_date":"2012-01-31","enrollment":148,"brief_title":"Thrombus Localization and Accompaying Disorders and Risk Factors","official_title":"Assessment of the Association Between Thrombus Localization and Accompaying Disorders ,Rsk Factors, D-Dimer and Red Cells Distribution Witdh In Pulmonary Embolisim","primary_completion_date":"2014-08-31","study_type":"Observational","rec_status":"Completed","completion_date":"2014-08-31","last_update":"2015-03-17","description":"ABSTRACT Pulmonary embolism shows a wide spectrum ranging from clinically asymptomatic thrombus to massive thrombus, leading to cardiogenic shock. The purpose of this study was to determine the association between thrombus localization and risk factors, accompanying disorders, D-dimer and the red blood cell distribution width (RDW) in patients with pulmonary embolism.","other_id":"YYU-015","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":81,"population":"The data confirmed on 148 patients having PE by CTPA in the Clinic of Chest Diseases,\r\n        Medical School, Yznc Yl University, Van, Turkey, in the period between January 2012 and\r\n        August 2014 were retrospectively studied. The patients' accompanying disorders, risk\r\n        factors, and the dosing of D-dimer performed on the same day of the CTPA and RDW levels\r\n        were noted. The patients who had a story of hospitalising for reasons other than surgery\r\n        such as Pneumonia, apses, brucella, encephalitis and the bedridden patients such as\r\n        hemiplegia and long-term immobilised patients (>72 hours) after surgery were listed in the\r\n        immobilisation group.\r\n\r\n        Patients receiving the diagnosis of PE with no CTPA performed and 6 patients whose\r\n        haemoglobin values were below 11 were not included in this study.","criteria":"\n        Inclusion Criteria:\r\n\r\n        - Pulmonary embolism Computed tomographic pulmonary angiography Red cell distribution width\r\n\r\n        Exclusion Criteria:\r\n\r\n        - Patients receiving the diagnosis of PE with no CTPA performed and 6 patients whose\r\n        haemoglobin values were below 11 were not included in this study.\r\n      ","sponsor":"Aysel Snnetiolu","sponsor_type":"Other","conditions":"Pulmonary Embolism","interventions":[{"intervention_type":"Radiation","name":"Radiation: Pulmonary embolism","description":"the thrombus were assessed with Computed tomographic pulmonary angiography"}],"outcomes":[{"outcome_type":"primary","measure":"association between thrombus localization and risk factors, accompanying disorders, D-dimer and red blood cell distribution width (RDW) in patients with pulmonary embolism.","time_frame":"up to 24 months"}]}
{"nct_id":"NCT02580487","start_date":"2012-01-31","enrollment":178,"brief_title":"Perioperative Pain Management of Pediatric Appendectomy Patients","official_title":"Perioperative Pain Management of Pediatric Appendectomy Patients in Kuopio University Hospital During the Years 2010-2012","primary_completion_date":"2015-09-30","study_type":"Observational","rec_status":"Completed","completion_date":"2015-10-31","last_update":"2015-10-20","description":"Acute appendicitis is the most common illness that brings pediatric patients to the hospital for surgical treatment. Abdominal pain is the symptom because of which the patients go to the hospital. Some patients have severe pain and need analgesics before the final diagnosis and before surgery. After surgery most patient experience pain and at least 80 % of the patients need postoperative pain medication. For two decades there has been a clinical guideline for pain management in Kuopio University Hospital (KUH). The investigators aim was to evaluate how well the pain management for pediatric patient works in clinical practice.","other_id":"KUH01012012","observational_model":"Cohort","sampling_method":"Probability Sample","gender":"All","maximum_age":18,"population":"152 pediatric patients that were operated on in KUH during the years 2010-2012 due to acute\r\n        appendicitis.\r\n\r\n        In addition we assessed 26 pediatric appendectomy patients and their pain at rest, when\r\n        coughing and when compressing the wound area propsectively when they were at hospital","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  In prospective patients informed consent obtained\r\n\r\n          -  Appendectomy performed\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  No informed consent\r\n      ","sponsor":"Kuopio University Hospital","sponsor_type":"Other","conditions":"Appendicitis","interventions":[{"intervention_type":"Procedure","name":"Procedure: appendicectomy","description":"Appendix was removed either laparoscopically or open surgery"}],"outcomes":[{"outcome_type":"primary","measure":"Pain","time_frame":"from preoperative evaluation until the patient left hospital maximum of 7 days","description":"pain is asked preoperatively and at the first postoperative day measured with numeral rating scale"},{"outcome_type":"secondary","measure":"amount of opioids used during hospital stay","time_frame":"from preoperative evaluation until the patient left hospital maximum of 7 days","description":"collected from patient files"}]}
{"nct_id":"NCT03954847","start_date":"2012-01-01","enrollment":1000,"brief_title":"Clinical Significance of Computer Aided Image Analysis in Treatment Response Evaluation of Lung Cancer","official_title":"Clinical Significance of Computer Aided Image Analysis in Treatment Response Evaluation of Lung Cancer","primary_completion_date":"2020-12-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2020-12-31","last_update":"2019-05-17","description":"The investigators will evaluate the utility of computer aided image analysis in lung cancer with the aim of predicting treatment response and prognosis.","other_id":"WuhanUH-V1.2","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Lung cancer patients with PET/CT or CT examination before any cancer-specific treatment","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patients >= 18 years old\r\n\r\n          2. Pathological diagnosis of NSCLC between 2012 and 2019;\r\n\r\n          3. PET/CT or CT examination before any cancer-specific treatment;\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. A time interval between treatment and image examination greater than 1 month;\r\n\r\n          2. A history of other malignancies\r\n      ","sponsor":"Wuhan Union Hospital, China","sponsor_type":"Other","conditions":"Lung Cancer","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Overall survival","time_frame":"2012-2021","description":"The interval between the date of diagnosis and death"},{"outcome_type":"secondary","measure":"Progression free survival","time_frame":"2012-2021","description":"The interval between the date of treatment initiation and disease progression"}]}
{"nct_id":"NCT04139083","start_date":"2012-01-01","enrollment":466,"brief_title":"The Clinical Outcome of TVM or LSC Mesh Suspension for POP","official_title":"The Clinical and Urodynamic Effects of Transvaginal or Laparoscopic Mesh Suspension for the Treatment of Pelvic Organ Prolapse","primary_completion_date":"2018-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2018-12-31","last_update":"2019-10-28","description":"The investigators aim to assess the surgical outcomes of transvaginal mesh (TVM) and laparoscopic (LSC) mesh suspension. During the study period, all women with main uterine prolapse stage II or greater defined by the POP quantification staging system receiving TVM or LSC mesh suspension were retrospectively recruited. Clinical evaluations before and 6 months after surgery included pelvic examination, urodynamic study, and a personal interview to evaluate urinary and sexual symptoms using questionnaires.","other_id":"KMUHIRB-E(I)-20190015","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"Female","minimum_age":20,"maximum_age":85,"population":"Women with mainly uterine prolapse stage II or greater as defined by the POP-Q staging\r\n        system","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Women with mainly uterine prolapse stage II or greater as defined by the POP-Q staging\r\n             system\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  A hypertrophic uterus, huge fibroids\r\n\r\n          -  History of cervical dysplasia or endometrial pathology\r\n\r\n          -  History of postmenopausal bleeding in the past 12 months\r\n\r\n          -  Unwilling to preserve their uterus\r\n      ","sponsor":"Kaohsiung Medical University Chung-Ho Memorial Hospital","sponsor_type":"Other","conditions":"Pelvic Organ Prolapse","interventions":[{"intervention_type":"Procedure","name":"Procedure: LSC mesh suspension","description":"Long mesh, a synthetic T-shaped mesh (Gynemsh, Ethicon, San Lorenzo, Puerto Rico), is delivered into the pelvic cavity. Bilateral mesh arms are extracted outside trocar wounds bilaterally to stabilize mesh position. The center piece is fixed to the cervix with 5mm ProTack screws (Covidien, New Haven, Connecticut). Fixation is strengthened with Stratafix 2-0 sutures (Ethicon, Norderstedt, Germany), followed by Tisseel fibrin sealant (Baxter, Deerfield, Illinois) for better hemostasis among surrounding tissues. An extraperitoneal tunnel is created along the left round ligament until reaching 2cm medial to the anterior superior iliac spine (ASIS). One arm of the long mesh is pulled out along the tunnel underneath round ligament and fixed with the fascia of oblique abdominis. The same procedure is repeated for the contralateral side. Bilateral round ligaments and the mesh arms are sutured continuously with Stratafix 2-0."},{"intervention_type":"Procedure","name":"Procedure: TVM","description":"Transvaginal mesh kit is delivered into the pelvis via vagina route."}],"outcomes":[{"outcome_type":"primary","measure":"Recurrence","time_frame":"12 months","description":"The POP-Q stage measurement after the operation"}]}
{"nct_id":"NCT01170468","start_date":"2011-12-31","phase":"Phase 3","enrollment":25,"brief_title":"Does Vitamin D Reduce Risk of Developing Type II DM in High Risk Individuals","official_title":"Does Vitamin D Reduce Risk of Developing Type II DM in Prediabetics? A Double Blind Randomized Controlled Trial","primary_completion_date":"2014-01-15","study_type":"Interventional","rec_status":"Terminated","completion_date":"2014-01-15","last_update":"2018-03-07","description":"Both vitamin D deficiency and type II DM/prediabetes are highly prevalent. Vitamin D status has been negatively associated with the presence of type II DM and glycemic control. A cause-effect relationship between vitamin D deficiency and the development of type II DM has not been established. The investigators plan to conduct a 2 year, double blind, randomized, placebo controlled trial on the effect of vitamin D3 supplement on the incidence of type II DM in high risk individuals.","other_id":"RAC 2101040","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adults living in Riyadh area with impaired fasting glucose or/and impaired glucose\r\n             tolerance (prediabetics) and total 25 OH vitamin D level between 10-30 nmol/l\r\n\r\n          -  Who consume no more than one serving of milk/day\r\n\r\n          -  Do not take vitamin supplement\r\n\r\n          -  Habitually have less than 10 hour of sun exposure per week\r\n\r\n          -  Don't suffer from granulomatus conditions, liver disease, kidney disease, or diabetes\r\n\r\n          -  Don't take anticonvulsants, barbiturates, steroids, or antidiabetic medications.\r\n      ","sponsor":"King Faisal Specialist Hospital & Research Center","sponsor_type":"Other","conditions":"Type 2 Diabetes Mellitus","interventions":[{"intervention_type":"Drug","name":"Drug: Vitamin D3","description":"Vitamin D3 5000 IU orally, daily for 2 years"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo orally, daily for 2 years"}],"outcomes":[{"outcome_type":"primary","measure":"The incidence of DM","time_frame":"2 years","description":"Development of DM diagnosed by glucose levels, fasting and/or 2-hour post 75 mg glucose challenge."},{"outcome_type":"secondary","measure":"slope of fasting glucose level","time_frame":"2 years"},{"outcome_type":"secondary","measure":"slope of 2-hour post challenge glucose level","time_frame":"2 years"},{"outcome_type":"secondary","measure":"area under the curve of BP","time_frame":"2 years"},{"outcome_type":"secondary","measure":"area under the curve of weight","time_frame":"2 years"},{"outcome_type":"secondary","measure":"area under the curve of 25 OH vitamin D level","time_frame":"2 years"},{"outcome_type":"secondary","measure":"fasting insulin to glucose ratio","time_frame":"2 years"},{"outcome_type":"secondary","measure":"incidence of hypercalcemia","time_frame":"2 years"},{"outcome_type":"secondary","measure":"incidence of hypercalciuria","time_frame":"2 years"},{"outcome_type":"secondary","measure":"time to develop DM","time_frame":"2 years","description":"Development of DM diagnosed by glucose levels, fasting and/or 2-hour post 75 mg glucose challenge."}]}
{"nct_id":"NCT01488188","start_date":"2011-12-31","phase":"Phase 1","enrollment":40,"brief_title":"Immunogenicity and Safety of Live Attenuated Influenza Vaccine (Flumist) Administered by Nasal and Sublingual Route","official_title":"A Controlled Study to Determine the Immunogenicity and Safety of Cold-adaptive Live Attenuated Influenza Vaccine (Flumist) Administered by the Nasal and Sublingual Route in Healthy Adult Volunteers","primary_completion_date":"2013-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-05-31","last_update":"2013-12-23","description":"Background: It is well established that live attenuated organisms can be highly effective vaccines, immune responses elicited can often be of greater magnitude and of longer duration than those produced by non-living antigens and are often able to confer protection after a single dose. Unlike killed influenza vaccine preparations injected by the parenteral route, live influenza vaccines are able to induce potent secretory (mainly IgA) antibody responses in the airway mucosae and can also evoke cell mediated responses. T cell proliferation, cytokine production, cytotoxic T cell responses and antibody-dependent cell cytotoxicity have all been elicited by live attenuated vaccines. There has been a history of the use of live attenuated flu vaccines as safe and effective vaccines for the prevention of flu in animals and humans. Live-attenuated cold-adapted influenza vaccines have been proved to be highly efficacious to protect against clinical fly symptoms. Among these, FluMist, a nasal vaccine formulation developed by Medimmune Inc, has been approved by the US FDA. Recent side by side clinical trials have demonstrated that this nasal vaccine was significantly superior to conventional killed flu vaccine in protecting against flu symptoms. Sublingual administration of live influenza virus at a dose lethal by the nasal route was well tolerated and did not redirect virus to the olfactory bulb. In addition, in a recent Phase I clinical study (NCT00820144) conducted in France, the sublingual administration of recombinant cholera toxin B subunit (rCTB,up to 1 mg) in healthy adult volunteers was found to be safe. A major issue has arisen regarding the ease with which vaccines could be administered to young children, especially infants, and to elderly subjects in whom nasal vaccination has not been possible and/or approved due to difficulties of administering nasal vaccines in infants and to undesired side effects related to frequent rhinitis and sneezing episodes in elderly subjects. This study is designed to investigate the safety, tolerability and immunogenicity of a new route of administration of vaccines, using the nasal FluMist formulation as prototype vaccine. Objectives: To evaluate the immunogenicity and safety of a nasal and sublingual influenza virus vaccine (FluMist) in healthy adult volunteers Study design: This will be a randomized study on a total 40 subjects; each 20 subjects will receive vaccine via nasal and sublingual route, respectively","other_id":"FM-01 V1","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":49,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy volunteers who are able and willing to give informed consent, following a\r\n             detailed explanation of participation in the study.\r\n\r\n          -  Volunteers who will be available for the duration of the study and available for\r\n             scheduled and potential additional visits\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subjects with any clinically significant medical or psychiatric condition or\r\n             clinically significant abnormal serum biochemistry or haematology results that, in\r\n             opinion of the Investigator, preclude participation in the study.\r\n\r\n          -  Female subjects who are pregnant (using urine test) or breast-feeding, or of\r\n             childbearing potential and unwilling to use a reliable method of contraception (e.g.\r\n             oral contraceptives or contraceptive during sexual activities such as a condom,\r\n             contraceptive diaphragm, intrauterine device, hormonal contraceptive, or intercourse\r\n             with a male partner who has had a vasectomy etc.) throughout the study period.\r\n\r\n          -  Subjects who have known airway hypersensitivity to one of Flu vaccine excipients\r\n             within 14 days prior to administration of study medication.\r\n\r\n          -  Subjects who have known buccal hypersensitivity to any component of the vaccine or\r\n             buffer solution used in this study, including subjects with phenylketonuria.\r\n\r\n          -  Subjects with direct contact with at risk groups (e.g. patients in special care units,\r\n             immuno-compromised individuals, pregnant women, children under 2 years of age and\r\n             individuals over 70 years).\r\n\r\n          -  Subjects with a known impairment of immune function including seropositive for HIV or\r\n             those receiving (or have received in the 6 months prior to study entry) cytotoxic\r\n             drugs immunosuppressive therapy (including systemic corticosteroids).\r\n\r\n          -  Subjects with a significant acute febrile illness (fever of 38.0 Celsius degree or\r\n             more) at time of dosing.\r\n\r\n          -  Subjects who have chronic diseases: Chronic diseases will include all autoimmune and\r\n             immuno-compromising conditions and any other chronic condition, which at the judgement\r\n             of the Investigator, may put the subject at higher risk of side effects from the study\r\n             vaccine. Conditions in the latter category might include unexplained anaemia,\r\n             hepato-biliary disease, uncontrolled hypertension, subjects with prosthetic joints or\r\n             heart valves, etc.\r\n\r\n          -  Subjects with a current problem, based on history, with substance abuse or with a\r\n             history of substance abuse\r\n\r\n          -  Subjects who are currently involved in a clinical trial, have taken an investigational\r\n             drug or have received investigational or licensed vaccines in the preceding 4 weeks or\r\n             anticipate receiving a vaccine other than study medication during the first 4 weeks of\r\n             the study\r\n\r\n          -  Subjects who have known hypersensitivity to eggs or egg proteins\r\n\r\n          -  Subjects who have chronic respiratory infections or syndromes\r\n\r\n          -  Unable to receive oral (sublingual) administration.\r\n\r\n          -  Receiving anti-viral agents.\r\n\r\n          -  Subjected to contraindications and/or precautions described in drug information\r\n      ","sponsor":"International Vaccine Institute","sponsor_type":"Other","conditions":"Healthy","interventions":[{"intervention_type":"Biological","name":"Biological: Influenza vaccine","description":"Administration of 1 dose (0.2 ml) by nasal route"},{"intervention_type":"Biological","name":"Biological: Influenza vaccine","description":"Administration of 1 dose (0.2 ml) by sublingual route"}],"outcomes":[{"outcome_type":"primary","measure":"Passive Haemagglutination Inhibition Titer.","time_frame":"21 days after vaccination","description":"Passive haemagglutination inhibition titer of serum at 21 days after vaccination."},{"outcome_type":"secondary","measure":"Blood Immunoglobulin G (IgG) and Immunoglobulin A (IgA)-Antibody Secreting Cell Number to Flu Virus","time_frame":"7 days after vaccination","description":"Flu virus-specific IgG- and IgA -antibody secreting cells per ml of blood at 7 days after vaccination"},{"outcome_type":"secondary","measure":"Salivary IgA","time_frame":"21 days after vaccination","description":"Salivary Flu-specific IgA titer at Days 21 after vaccination"},{"outcome_type":"secondary","measure":"Cell Mediated Immune Responses","time_frame":"21 days after vaccination","description":"Interferon gamma production in peripheral blood monocyte (PBMC) after in vitro re-stimulation with influenza virus antigen at 21 days after vaccination."}]}
{"nct_id":"NCT01519271","start_date":"2011-12-31","phase":"Phase 4","enrollment":28,"brief_title":"Mild Cognitive Impairment in Parkinson's Disease","official_title":"A Phase IV Randomized, Double-Blind, Placebo-Controlled, Crossover Single Site Study Of Exelon Patch (Rivastigmine Transdermal System) For Mild Cognitive Impairment In Parkinson's Disease","primary_completion_date":"2014-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-06-30","last_update":"2017-04-07","description":"Mild cognitive impairment, including difficulty with solving problems, planning, attention, or recalling information, can be a significant problem for individuals with Parkinson's disease. Even mild cognitive difficulties can lead to worse functioning, quality of life, depression, and difficulty for caregivers. Thus, ideally treatment at this stage would improve both cognitive symptoms and some of the other problems associated with these symptoms. Despite the fact that mild cognitive impairment is a serious problem for Parkinson's disease patients little is known about how best to treat it. This study is a 24-week clinical trial to see if a Food and Drug Administration (FDA)-approved drug, the Exelon (rivastigmine) Patch, is useful in treating mild cognitive impairment in patients with Parkinson's disease. Currently, the Exelon (rivastigmine) Patch is FDA-approved for the treatment of mild to moderate dementia in Alzheimer and Parkinson's disease patients.","other_id":"813803","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":40,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Participants must be experiencing symptoms of mild cognitive impairment; this will be\r\n             determined by study personnel.\r\n\r\n          2. Participants must be on a sable medication regimen for 2 months prior to starting the\r\n             study (necessary dose adjustments during the study are acceptable).\r\n\r\n          3. Participants are capable of giving informed consent supported by not meeting\r\n             Parkinson's disease Dementia criteria; this will be determined by study personnel.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Active suicide ideation.\r\n\r\n          2. Weighing less than 100 lbs (45 kgs).\r\n\r\n          3. History of Deep Brain Stimulation surgery.\r\n\r\n          4. Diagnosis of Dementia\r\n\r\n          5. Taking certain types of medications may be an exclusion criteria, this will be\r\n             reviewed with all potential participants.\r\n\r\n          6. Females that are pregnant, planning to become pregnant, or are breastfeeding will not\r\n             be included in the study. Females of childbearing potential will need to verify that\r\n             they are not pregnant by a negative urine pregnancy test.\r\n      ","sponsor":"University of Pennsylvania","sponsor_type":"Other","conditions":"Parkinson's Disease|Mild Cognitive Impairment","interventions":[{"intervention_type":"Drug","name":"Drug: Exelon Patch (rivastigmine transdermal system)","description":"The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.\r\n5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )"},{"intervention_type":"Drug","name":"Drug: Placebo Patches","description":"The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine)."}],"outcomes":[{"outcome_type":"primary","measure":"Alzheimer's Disease Cooperative Study- Clinical Global Impression Change (ADCS-CGIC)","time_frame":"The ADCS-CGIC will be administered at the end of each study phase.","description":"The ADCS-CGIC is the most commonly used measure of global change in dementia psychopharmacology studies. This assessment is a measure of change, thus it is not appropriate for baseline administration and only administered at the end of phase visit.\r\nThe scale rates total improvement on a 7 point scale:\r\n= Very much improved\r\n= Much improved\r\n= Minimally improved\r\n= No change\r\n= Minimally worse\r\n= Much worse\r\n= Very much worse\r\nA participant scoring a 1 or 2 is considered a responder on the CGI scale."},{"outcome_type":"secondary","measure":"Montreal Cognitive Assessment (MoCA)","time_frame":"The MoCA was administered in the beginning and end of each study phase.","description":"The MoCA will be used as the global cognitive screening instrument. It will also be administered in the clinical trial at baseline and the final visits of each phase as a secondary outcome measure of global cognition. Scores on the MoCA range from 0-30 with 26-30 indicating normal global cognition."}]}
{"nct_id":"NCT01494545","start_date":"2011-12-31","phase":"N/A","enrollment":102,"brief_title":"Performance Evaluation of DAILIES TOTAL1 in First Time Contact Lens Wearers","official_title":"Performance Evaluation of DAILIES TOTAL1 in First Time Contact Lens Wearers","primary_completion_date":"2012-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-04-30","last_update":"2013-07-19","description":"The purpose of this study was to evaluate the performance of DAILIES TOTAL1 in first time contact lens wearers.","other_id":"P-347-C-016","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":44,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Sign Informed Consent.\r\n\r\n          -  No previous contact lens experience or attempt to try contact lenses (neophyte).\r\n\r\n          -  Willing to wear study lenses for at least 8 hours a day for at least 5 days a week.\r\n\r\n          -  Use spectacle lenses for vision correction.\r\n\r\n          -  Other protocol-defined inclusion criteria may apply.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  45 years or older.\r\n\r\n          -  Prior wear experience with rigid or soft contact lenses.\r\n\r\n          -  Systemic or ocular disease or disorder that would negatively affect the conduct or\r\n             outcome of the study.\r\n\r\n          -  History of ocular surgery/trauma within the last six months.\r\n\r\n          -  Pregnant or nursing women.\r\n\r\n          -  Participation in any other ophthalmic drug or device clinical trial within 30 days of\r\n             enrollment.\r\n\r\n          -  Other protocol-defined exclusion criteria may apply.\r\n      ","sponsor":"Alcon Research","sponsor_type":"Industry","conditions":"Myopia","interventions":[{"intervention_type":"Device","name":"Device: Delefilcon A contact lens","description":"Silicone hydrogel contact lens CE-marked for single use, daily disposable wear"}],"outcomes":[{"outcome_type":"primary","measure":"Likert Statement: These Contact Lenses Are Perfect for When I Choose Not to Wear my Eye Glasses.","time_frame":"Day 14","description":"The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes."},{"outcome_type":"primary","measure":"Likert Statement: I Liked These Contact Lenses so Much That I Will Recommend Them to my Friends.","time_frame":"Day 14","description":"The participant indicated agreement/disagreement with the statement by using a 4-point scale: 22=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes."},{"outcome_type":"primary","measure":"Likert Statement: Overall, my Vision is Better With These Contact Lenses Compared to my Eye Glasses.","time_frame":"Day 14","description":"The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes."},{"outcome_type":"primary","measure":"Initial Comfort","time_frame":"Day 1","description":"Initial comfort was rated by the participant and recorded on a questionnaire at time of lens dispense. Initial comfort was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes."},{"outcome_type":"primary","measure":"Comfort at Insertion by Visit","time_frame":"Day 7, Day 14","description":"Comfort at insertion was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Comfort at insertion was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes."},{"outcome_type":"primary","measure":"Comfort During the Day by Visit","time_frame":"Day 7, Day 14","description":"Comfort during the day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Comfort during the day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes."},{"outcome_type":"primary","measure":"Comfort at End of Day by Visit","time_frame":"Day 7, Day 14","description":"Comfort at end of day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Comfort at end of day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes."},{"outcome_type":"primary","measure":"Overall Comfort by Visit","time_frame":"Day 7, Day 14","description":"Overall comfort was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Overall comfort was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes."},{"outcome_type":"primary","measure":"Initial Quality of Vision","time_frame":"Day 1","description":"Initial quality of vision was rated by the participant and recorded on a questionnaire at time of lens dispense. Initial quality of vision was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes."},{"outcome_type":"primary","measure":"Quality of Vision at Insertion by Visit","time_frame":"Day 7, Day 14","description":"Quality of vision at insertion was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Quality of vision at insertion was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes."},{"outcome_type":"primary","measure":"Quality of Vision During the Day by Visit","time_frame":"Day 7, Day 14","description":"Quality of vision during the day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Quality of vision during the day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes."},{"outcome_type":"primary","measure":"Quality of Vision at End of Day by Visit","time_frame":"Day 7, Day 14","description":"Quality of vision at end of day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Quality of vision at end of day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes."},{"outcome_type":"primary","measure":"Overall Quality of Vision by Visit","time_frame":"Day 7, Day 14","description":"Overall quality of vision was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Overall quality of vision was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes."},{"outcome_type":"primary","measure":"Average Comfortable Daily Wear Time by Visit","time_frame":"Day 7, Day 14","description":"Average comfortable daily wear time was reported by the participant as a single, retrospective evaluation of the previous week of wear."},{"outcome_type":"primary","measure":"Likert Statement: These Contact Lenses Were so Comfortable That I Don't Feel Anything.","time_frame":"Day 14","description":"The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes."},{"outcome_type":"primary","measure":"Likert Statement: These Contact Lenses Were so Comfortable That I Barely Felt Anything.","time_frame":"Day 14","description":"The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes."},{"outcome_type":"primary","measure":"Likert Statement: These Contact Lenses Felt so Comfortable That I Forgot I Was Wearing Them.","time_frame":"Day 14","description":"The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes."},{"outcome_type":"primary","measure":"Likert Statement: At the End of the Day my Vision is Better With These Contacts Lenses Compared to my Eye Glasses.","time_frame":"Day 14","description":"The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=strongly agree; 1=agree; -1=disagree; -2=strongly disagree. A single assessment was made for both eyes."},{"outcome_type":"primary","measure":"Likert Statement: My Peripheral Vision is Better With These Contact Lenses Than With my Eye Glasses.","time_frame":"Day 14","description":"The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes."},{"outcome_type":"primary","measure":"Likert Statement: Compared to my Eye Glasses, my Vision With These Contact Lenses is:","time_frame":"Day 14","description":"The participant indicated overall satisfaction/dissatisfaction with the contact lenses using a 5-point scale: 2=Much Better; 1=A Little Better; 0=Same; -1=A Little Worse; -2=Much Worse. A single assessment was made for both eyes."},{"outcome_type":"primary","measure":"Likert Statement: I am Interested in Purchasing These Contact Lenses.","time_frame":"Day 14","description":"The participant indicated purchase intent using a 4-point scale: 2=Very Interested; 1=Interested; -1=Not Interested; -2=Very Disinterested. A single assessment was made for both eyes."},{"outcome_type":"secondary","measure":"Lens Surface Characteristics: Dry Areas/Non-wetting","time_frame":"Day 1","description":"The investigator assessed the surface of the contact lens while the lens was on the participant's eye for dry areas/non-wetting: 0=None; 1=Very Slight; 2-Slight; 3=Moderate; 4=Severe. Assessments were made individually (by eye) and binocularly (both eyes together)."},{"outcome_type":"secondary","measure":"Lens Surface Characteristics: Dry Areas/Non-Wetting","time_frame":"Day 7","description":"The investigator assessed the surface of the contact lens while the lens was on the participant's eye for dry areas/non-wetting: 0=None; 1=Very Slight; 2-Slight; 3=Moderate; 4=Severe. Assessments were made individually (by eye) and binocularly (both eyes together)."},{"outcome_type":"secondary","measure":"Lens Surface Characteristics: Dry Areas/Non-Wetting","time_frame":"Day 14","description":"The investigator assessed the surface of the contact lens while the lens was on the participant's eye for dry areas/non-wetting: 0=None; 1=Very Slight; 2-Slight; 3=Moderate; 4=Severe. Assessments were made individually (by eye) and binocularly (both eyes together)."},{"outcome_type":"secondary","measure":"Duration of Overall Training Time","time_frame":"Day 1","description":"The investigator recorded the time it took for the patient to insert both lenses and remove both lenses, not including instructions."},{"outcome_type":"secondary","measure":"Investigator's Satisfaction With Lens Fit by Visit","time_frame":"Day 1, Day 7, Day 14","description":"The investigator considered the factors that relate to a well-fitted contact lens, including good centration, adequate movement, and complete corneal coverage, and rated his/her satisfaction with the contact lens fit on 10-point scale, with 1 being not at all satisfied and 10 being very satisfied."},{"outcome_type":"secondary","measure":"Investigator's Overall Impression of Surface Wettability by Visit","time_frame":"Day 1, Day 7, Day 14","description":"The investigator rated his/her overall impression of the surface wettability of the contact lens on a 10-point scale (1=poor to 10=excellent)."},{"outcome_type":"secondary","measure":"Investigator's Rating of Ease of Fit","time_frame":"Day 14","description":"The investigator indicated agreement/disagreement with the statement, \"The study lenses were easy to fit for this subject,\" by using a 4-point scale: 1=Strongly Agree; 2=Agree; 3=Disagree; 4=Strongly Disagree."}]}
{"nct_id":"NCT01170507","start_date":"2011-12-31","phase":"Phase 1/Phase 2","enrollment":0,"brief_title":"Magnitude of Changes in 25 OH Vitamin D3 Levels After Vitamin D3 Supplementation","official_title":"Magnitude of Changes in 25 OH Vitamin D3 Levels After Vitamin D3 Supplementation: A Randomized Controlled Study","primary_completion_date":"2016-08-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2016-08-31","last_update":"2018-03-07","description":"Vitamin D deficiency is common world wide. 25 OH vitamin D level is the best indicator of vitamin D status. The determination of the appropriate dose of vitamin D supplement is essential for management of vitamin D deficiency as well as for designing vitamin D fortification programs. The increments in 25 OH vitamin D levels following various doses of vitamin D supplement for different genders, body weights, and starting 25 OH vitamin D level have not been well defined. The time course of depletion of repleted vitamin D stores is also not known. The investigators plan to conduct a double blind randomized study on 9 cohorts to determine levels of 25 OH vitamin D following supplementation with different doses of vitamin D3 for 5 months and their withdrawal for 3 months.","other_id":"RAC 2101042","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adults living in Riyadh area who consume no more than one serving of milk/day, do not\r\n             take vitamin supplement, habitually have less than 10 hr of sun exposure per week,\r\n             don't suffer from granulomatous conditions, liver disease, or kidney disease, and\r\n             don't take anticonvulsants, barbiturates, or steroids.\r\n\r\n          -  Individuals with with total 25 OH vitamin D level exceeding 100 nmol/l will be\r\n             excluded from the study. Individuals with 25 OH vitamin D levels less than 20 nmol/L\r\n             will be excluded from the placebo arm.\r\n      ","sponsor":"King Faisal Specialist Hospital & Research Center","sponsor_type":"Other","conditions":"Vitamin D Deficiency","interventions":[{"intervention_type":"Drug","name":"Drug: vitamin D3 1000 IU orally daily for 5 months"},{"intervention_type":"Drug","name":"Drug: vitamin D3 3000 IU orally daily for 5 months"},{"intervention_type":"Drug","name":"Drug: vitamin D3 5000 IU orally daily for 5 months"},{"intervention_type":"Drug","name":"Drug: Placebo orally daily for 5 months"}],"outcomes":[{"outcome_type":"primary","measure":"Slope of 25 OH vitamin D3 level vs vitamin D3 dose","time_frame":"5 months","description":"The primary endpoint is the slope of the dose (vitamin D3)- response (25 OH vitamin D3 level) curve for each cohort. The slope of the placebo group will be used to determine changes in 25 OH vitamin D3 levels that are not related to study intervention. The slope will be determined over 5 months."},{"outcome_type":"secondary","measure":"slope of vitamin D3 level vs vitamin D3 dose","time_frame":"5 months","description":"slope of vitamin D3 level vs vitamin D3 dose over 5 months"},{"outcome_type":"secondary","measure":"incidence of hypercalcemia","time_frame":"8 months","description":"incidence of hypercalcemia over 8 months"},{"outcome_type":"secondary","measure":"incidence of hypercalciuria","time_frame":"8 months","description":"incidence of hypercalciuria over 8 months"},{"outcome_type":"secondary","measure":"slope of decline of 25 OH vitamin D3 level vs time","time_frame":"3 months","description":"slope of decline of 25 OH vitamin D3 level vs time over 3 months"}]}
{"nct_id":"NCT01735539","start_date":"2011-12-31","phase":"N/A","enrollment":40,"brief_title":"Dysfunction of Nutritive Blood Flow as a Determinant of Anabolic Resistance With Age; the Role of Amino Acids in Modulating Muscle Metabolism","official_title":"Dysfunction of Nutritive Blood Flow as a Determinant of Anabolic Resistance in Older People; The Role of Essential Amino Acids in Modulating Muscle Protein Metabolism; Bolus vs. Pulse Feeding Strategies and the Ability of Arginine to Rejuvenate Microvascular Responsiveness.","primary_completion_date":"2014-01-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2014-01-31","last_update":"2014-01-17","description":"The investigators plan to measure changes in muscle protein metabolism in response to feeding, comparing between a single large essential amino acid (EAA) feed (the normal building blocks of protein) and the provision of the same dose in 4 smaller feeds at 45min intervals. The investigators will perform this study in healthy older (65-75y) and younger (18-28) men. The investigators will also explore how feeding affects muscle blood flow as this is important in the delivery of the nutrients we eat to the muscle where they are used. The investigators plan to supplement the feed with arginine, a safe and widely found non-essential amino acid, to explore if this can improve muscle blood flow.","other_id":"UNottingham F/3/2009","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  age 65-75 or 18-28\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  BMI >30\r\n\r\n          -  Diabetes\r\n\r\n          -  Beta blocker or steroid use\r\n\r\n          -  Established cerebrovascular, peripheral vascular or ischaemic heart disease.\r\n      ","sponsor":"University of Nottingham","sponsor_type":"Other","conditions":"Old Age (Focus; Not a Recognized Condition)","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: 15g EAA bolus","description":"Oral; in aqueous solution"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: 4 x 3.75g Mixed EAA Pulses","description":"Oral; in aqueous solution"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: 15g EAA Bolus supplemented with 3g Arginine","description":"Oral; in aqueous solution"}],"outcomes":[{"outcome_type":"primary","measure":"Muscle Protein Synthesis (FSR, fractional synthetic rate, %/hr)","time_frame":"Across 6hr study","description":"We measure FSR when fasted and again 0-90, 90-180 and 180-240 post feed."},{"outcome_type":"secondary","measure":"Muscle Protein Breakdown (MPB)","time_frame":"Across 6hr study","description":"MBP is measured during fasting and 0-90, 90-180 and 180-240mins post feed."},{"outcome_type":"secondary","measure":"Whole leg blood flow","time_frame":"Across a 6hr study","description":"We measure common femoral blood flow by doppler ultrasound when fasted and again 0-90, 90-180 and 180-240 post feed."},{"outcome_type":"secondary","measure":"Muscle Microvascular Blood flow","time_frame":"Across a 6hr study","description":"We measure muscle microvascular flow using contrast enhanced ultrasound when fasted and again 0-90, 90-180 and 180-240 post feed."}]}
{"nct_id":"NCT01500746","start_date":"2011-12-31","phase":"N/A","enrollment":8,"brief_title":"Evaluation of the Effectiveness of Daily Pulse Lavage Therapy in Chronic Wounds","official_title":"Bedside Pulse Lavage Irrigation Project","primary_completion_date":"2013-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-10-31","last_update":"2014-04-14","description":"This study evaluates the effectiveness of pulse lavage therapy in decreasing bacterial counts in chronic wounds.","other_id":"STU00057288","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patients must have a chronic wound (as defined by the wound being present for >30\r\n             days) located on any part of their body\r\n\r\n          2. The wound must be smaller than 10cm in greatest diameter.\r\n\r\n          3. Patients must have an expected remaining hospital duration of 4 days\r\n\r\n          4. Patients must be willing and able to comply with all study procedures\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients must not have undergone any surgical excisions or debridements of the wound\r\n             in the past 30 days\r\n\r\n          2. The wound may not undergo any surgical procedures or other treatments other than the\r\n             study treatments during the course of the study.\r\n\r\n          3. The wound may not require any immediate surgical intervention or debridement\r\n\r\n          4. Patients may not start any new antibiotic therapy during the course of the study\r\n\r\n          5. Must not have an allergy to skin adhesives.\r\n\r\n          6. Patients must not be taking any immunosuppressive medications.\r\n\r\n          7. Subjects who, in the opinion of the investigator, may not complete the study for any\r\n             reason.\r\n      ","sponsor":"Northwestern University","sponsor_type":"Other","conditions":"Chronic Wounds","interventions":[{"intervention_type":"Procedure","name":"Procedure: Pulse lavage treatment","description":"A pulse lavage machine will be used to irrigate the wound with a total of 4 liters of water, twice daily, for a total of 4 days (8 treatments)."},{"intervention_type":"Other","name":"Other: Dressing changes","description":"Wounds will be treated with moist gauze dressing changes twice daily for a total of 4 days (8 treatments)."}],"outcomes":[{"outcome_type":"primary","measure":"Change in Bacterial Counts","time_frame":"Baseline and at 4 days","description":"A punch biopsy of the wound will be taken once the subject is enrolled in the study. A repeat biopsy will be taken after the 8th lavage treatment or the 8th dressing change. These will be sent for bacterial count analysis and the difference in bacterial counts will be evaluated. The lavage fluid from baseline measurements will be filtered and sent for bacterial counts and will be compared to the filtered fluid from the last lavage treatment. In addition, surface swabs will be taken at the beginning and end of the study and will be sent for bacterial counts as well. Bacterial counts from these lavage, biopsy specimen, and swabs will be averaged and analyzed."},{"outcome_type":"primary","measure":"Change in Gene Expression Analysis","time_frame":"4 days","description":"A punch biopsy will be taken at the beginning of the study. this will be sent for gene expression analysis. A repeat biopsy at the end of the study will also be sent at the end of the study, and a change in gene expression in analysis will be evaluated."},{"outcome_type":"secondary","measure":"Pain With Lavage Treatments","time_frame":"4 days","description":"After each lavage treatment, the subjects will complete a visual analogue scale that will determine the level of discomfort that they experienced during the study."}]}
{"nct_id":"NCT01497366","start_date":"2011-12-31","phase":"Phase 3","enrollment":527,"brief_title":"Phase 3 Study of Sofosbuvir and Ribavirin","official_title":"A Phase 3, Multicenter, Randomized, Active-Controlled Study to Investigate the Safety and Efficacy of PSI-7977 and Ribavirin for 12 Weeks Compared to Pegylated Interferon and Ribavirin for 24 Weeks in Treatment-Nave Patients With Chronic Genotype 2 or 3 HCV Infection","primary_completion_date":"2013-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-04-30","last_update":"2014-04-02","description":"This study was to assess the safety and efficacy of sofosbuvir (GS-7977; PSI-7977) in combination with ribavirin (RBV) administered for 12 weeks compared with pegylated interferon (PEG)/RBV administered for 24 weeks in treatment-naive patients with Hepatitis C (HCV) genotype 2 or 3. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12). This was a non-inferiority study, and if non-inferiority was demonstrated, the study was then allowed to test for superiority.","other_id":"P7977-1231","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Chronic Genotype 2 or 3 HCV-infection\r\n\r\n          -  Naive to all HCV antiviral treatment(s)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Positive test at Screening for HBsAg, anti-hepatitis B core immunoglobulin M antibody\r\n             (anti-HBc IgM Ab), or anti-HIV Ab\r\n\r\n          -  History of any other clinically significant chronic liver disease\r\n\r\n          -  A history consistent with decompensated liver disease\r\n\r\n          -  History or current evidence of psychiatric illness, immunologic disorder,\r\n             hemoglobinopathy, pulmonary or cardiac disease, seizure disorder or anticonvulsant\r\n             use, poorly controlled diabetes, cancer, or a history of malignancy, that makes the\r\n             subject unsuitable for the study.\r\n\r\n          -  Participation in a clinical study within 3 months prior to first dose\r\n      ","sponsor":"Gilead Sciences","sponsor_type":"Industry","conditions":"Hepatitis C","interventions":[{"intervention_type":"Drug","name":"Drug: Sofosbuvir","description":"Sofosbuvir 400 mg (2  200 mg tablets) administered orally once daily"},{"intervention_type":"Drug","name":"Drug: PEG","description":"Pegylated interferon alfa-2a (PEG) 180 g administered once weekly by subcutaneous injection"},{"intervention_type":"Drug","name":"Drug: RBV","description":"Ribavirin (RBV) administered as 200 mg tablets up to 1200 mg in a divided daily dose\r\nDose of sofosbuvir+RBV group based on baseline weight: < 75kg = 1000 mg and  75 kg = 1200 mg\r\nDose of PEG+RBV group: 800 mg"}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12)","time_frame":"Post-treatment Week 12","description":"SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; < 25 IU/mL) 12 weeks after study drug cessation."},{"outcome_type":"secondary","measure":"Number of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities","time_frame":"Up to 24 weeks plus 30 days following the last dose of study drug"},{"outcome_type":"secondary","measure":"Percentage of Participants With Sustained Virologic Response 24 Weeks After Stopping All Study Drugs (SVR24)","time_frame":"Post-treatment Week 24","description":"SVR24 was defined as HCV RNA < LLOQ 24 weeks after study drug cessation."},{"outcome_type":"secondary","measure":"Percentage of Participants With HCV RNA < LLOQ on Treatment","time_frame":"Up to 12 Weeks"},{"outcome_type":"secondary","measure":"Change From Baseline in HCV RNA","time_frame":"Baseline to Week 12"},{"outcome_type":"secondary","measure":"Percentage of Participants With Virologic Failure During Treatment","time_frame":"Baseline up to Week 24","description":"Virologic failure was defined as either\r\nViral breakthrough: HCV RNA ≥ 25 IU/mL after having previously had HCV RNA < 25 IU/mL while on treatment, confirmed with 2 consecutive values or last available measurement\r\nViral rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values or last available measurement\r\nNon-response: HCV RNA persistently ≥ 25 IU/ml while on treatment (through Week 12)"},{"outcome_type":"secondary","measure":"Percentage of Participants With Viral Relapse Following Treatment","time_frame":"Up to Post-treatment Week 24","description":"Viral relapse was defined as HCV RNA ≥ 25 IU/mL in post-treatment after having achieved < LLOQ at last on-treatment measurement, confirmed with 2 consecutive values or last available measurement."}]}
{"nct_id":"NCT01478464","start_date":"2011-12-31","phase":"N/A","enrollment":22,"brief_title":"Effect of Massage on Hamstring Muscle Soreness","official_title":"Danish: Integreret Motion p Arbejdspladsen (IRMA) English: Implementation of Exercise at the Workplace","primary_completion_date":"2012-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-11-30","last_update":"2013-06-28","description":"Delayed onset muscular soreness peaks in 24-48 hours after unaccustomed strenuous physical exercise. Therapists often provide manual massage with the hands to acutely relief the soreness. Alternatives to manual hand massage can be useful for therapists. Here the investigators examine the acute effect of a \"massage roller\" on DOMS in the hamstring muscles","other_id":"IRMA03","allocation":"Randomized","intervention_model":"Factorial Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":67,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  working age adults\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  blood pressure above 160/100\r\n\r\n          -  disease of the cervical spine\r\n      ","sponsor":"National Research Centre for the Working Environment, Denmark","sponsor_type":"Other","conditions":"Musculoskeletal Disorders","interventions":[{"intervention_type":"Other","name":"Other: Massage","description":"The hamstring muscle will be massaged with a \"massage roller\" for ten minutes."}],"outcomes":[{"outcome_type":"primary","measure":"Perceived soreness on a scale of 0-10","time_frame":"change from before to after massage (average of 0, 10, 30 and 60 min after)","description":"0: no soreness 10: worst imaginable soreness"},{"outcome_type":"secondary","measure":"Pressure pain threshold (PPT) of the hamstring muscles","time_frame":"change from before to after massage (average of 0, 10, 30 and 60 min after)"},{"outcome_type":"secondary","measure":"Hamstring range of motion","time_frame":"change from before to after massage (average of 0, 10, 30 and 60 min after)"}]}
{"nct_id":"NCT02661321","start_date":"2011-12-31","enrollment":35,"brief_title":"Location and Timing of Inhaler Use, Exacerbations and Physical Activity in Chronic Obstructive Pulmonary Disease","official_title":"Location and Timing of Inhaler Use, Exacerbations and Physical Activity in Chronic Obstructive Pulmonary Disease","primary_completion_date":"2014-01-31","study_type":"Observational","rec_status":"Completed","completion_date":"2014-01-31","last_update":"2016-01-22","description":"This was an observational pilot study to examine the usefulness of an electronic sensor that monitors short-acting beta-agonist inhaled medication use. The goals of this study were to: 1) test the feasibility of using the inhaler sensor to measure worsening symptoms and exacerbations, 2) characterize physical activity in patients with COPD, and 3) examine whether environmental factors can be linked to mild exacerbations measured by the inhaler sensor.","other_id":"VA HSR&D PPO 10-299","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients with chronic obstructive pulmonary disease at VA Puget Sound Health Care System in\r\n        Seattle, WA","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  FEV1/FVC<0.70\r\n\r\n          -  FEV1 >30% and <FEV1<65% predicted\r\n\r\n          -  Participants must be able to walk without assistance\r\n\r\n          -  No plans to leave the study area during the 12-week study period\r\n\r\n          -  Non-smoker and not live with someone who smokes\r\n\r\n          -  No history of asthma\r\n\r\n          -  Use a short-acting bronchodilator\r\n      ","sponsor":"VA Puget Sound Health Care System","sponsor_type":"U.S. Fed","conditions":"Chronic Obstructive Pulmonary Disease","interventions":[{"intervention_type":"Other","name":"Other: No intervention was used in this study, this was an observational study"}],"outcomes":[{"outcome_type":"primary","measure":"Exacerbations","time_frame":"3 months","description":"Number of exacerbations during the 3-month follow-up period"},{"outcome_type":"secondary","measure":"Physical activity: Total number of steps per day","time_frame":"Up to 3 months","description":"An Omron pedometer was used by patients for 7 days at baseline, week 4, week 10 during the 3 month follow-up period."}]}
{"nct_id":"NCT01924221","start_date":"2011-12-31","enrollment":70,"brief_title":"Reverse Electrical Remodeling of Native Conduction in Cardiac Resynchronization Therapy","official_title":"Study of Reverse Electrical Remodeling of Native Conduction in Cardiac Resynchronization Therapy","primary_completion_date":"2022-12-31","study_type":"Observational","rec_status":"Active, not recruiting","completion_date":"2022-12-31","last_update":"2021-08-10","description":"Cardiac resynchronization therapy with pacemaker alone, or in combination with a cardioverter-defibrillator, prolongs life and decreases risk of heart failure exacerbation in patients with low ejection fraction and wide QRS. Some patients achieve decrease in QRS duration 6 months after cardiac resynchronization therapy. Such phenomenon is called reverse electrical remodeling of native conduction. Retrospective analysis showed that reverse electrical remodeling of the native conduction after at least 6 months of CRT is associated with decreased rate of ventricular arrhythmias and better survival. This study is designed to study reverse electrical remodeling prospectively.","other_id":"NA_00065477","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":100,"population":"Heart Failure Patients undergoing implantation of cardiac resynchronization therapy\r\n        defibrillator","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  patients undergoing implantation of a CRT-D\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  age < 18 y\r\n\r\n          -  pregnancy or planned pregnancy\r\n      ","sponsor":"Johns Hopkins University","sponsor_type":"Other","conditions":"Heart Failure|Patients Undergoing CRT-D Device Implantation","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"correlation between electrical and mechanical remodeling","time_frame":"6 months after CRT implantation","description":"correlation between electrical and mechanical measures of dyssynchrony"}]}
{"nct_id":"NCT01453946","start_date":"2011-12-31","phase":"Phase 3","enrollment":55,"brief_title":"Safety and Maintenance Study of Entocort for Children With Crohn's Disease","official_title":"A Multicenter, Open Label, Non-comparative Study to Evaluate the Safety of Entocort EC as a Maintenance Treatment for Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive","primary_completion_date":"2014-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-02-28","last_update":"2017-01-04","description":"A Safety for Maintenance of Entocort EC for children with mild to moderate Crohn's Disease.","other_id":"D9422C00002","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":5,"maximum_age":17,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  All male and female subjects must be aged 5 to 17, inclusive, and must not have\r\n             reached their 18th birthday by the estimated final office visit.\r\n\r\n          -  All subjects must weight >= 15 kg at the time of enrollment.\r\n\r\n          -  Subjects must have been diagnosed and treated for active Crohn's disease of the ileum\r\n             and/or ascending colon confirmed by endoscopic and/or radiographic evidence, and/or\r\n             evidence of mucosal erosions and/or histology and have a PCDAI <= 10\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subjects who have had any previous intestinal resection proximal to and including the\r\n             ascending colon.\r\n\r\n          -  Subjects with evidence of active Crohn's disease (PCDAI > 10) and/or stricturing,\r\n             prestenotic dilatation, clinical evidence of obstruction, perirectal abscess,\r\n             perirectal disease with active draining fistulas, perforation, or any septic\r\n             complications.\r\n\r\n          -  Subjects with morning cortisol level <150 nmol/l (5.4 ug/dl) or DHEA-S below normal\r\n             range for age and gender (NOTE: Subjects from the induction protocol with abnormal\r\n             morning cortisol/DHEA-S levels at Visit 4, who otherwise meet the eligibility\r\n             criteria, may be enrolled if the investigator decides that Entocort 6 mg is an\r\n             appropriate therapy option.\r\n      ","sponsor":"Perrigo Company","sponsor_type":"Industry","conditions":"Crohn's Disease","interventions":[{"intervention_type":"Drug","name":"Drug: Entocort","description":"Entocort capsules, taken orally, 6 mg daily."}],"outcomes":[{"outcome_type":"primary","measure":"Adverse Event","time_frame":"16 weeks","description":"Any kind of adverse event"},{"outcome_type":"secondary","measure":"PCDAI","time_frame":"12 weeks","description":"Pediatric Crohn's Disease Activity Index. The scale ranges from 0 (no activity) to 100 (high activity)"},{"outcome_type":"secondary","measure":"IMPACT 3","time_frame":"12 weeks","description":"IMPACT-III - A QUALITY OF LIFE QUESTIONNAIRE FOR CHILDREN WITH INFLAMMATORY BOWEL DISEASE"}]}
{"nct_id":"NCT01501617","start_date":"2011-12-31","phase":"Phase 1/Phase 2","enrollment":56,"brief_title":"Safety and Efficacy of Hair Stimulating Complex (HSC) on Hair Growth in Males With Androgenetic Alopecia","official_title":"The Clinical Effects of HSC (Hair Stimulating Complex) on Hair Growth in Androgenetic Alopecia: A Phase I/II Clinical Trial","primary_completion_date":"2012-06-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2012-12-31","last_update":"2012-01-18","description":"The purpose of this study is to evaluate the safety and efficacy in relation to dosing in the administration of Hair Stimulating Complex (HSC) in healthy men. HSC will be injected intradermally in the scalps of men with male pattern baldness (i.e. androgenetic alopecia).","other_id":"11-HIS006-PH","allocation":"Randomized","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"Male","minimum_age":21,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Male, ages 21-65 years.\r\n\r\n          2. A healthy scalp with no cutaneous disorder.\r\n\r\n          3. Subject should be in good general health.\r\n\r\n          4. Male subjects must be classified 3 Vertex, 4, 4A (if large enough), 5, 5A, or 6 under\r\n             the Norwood-Hamilton Classification for Male Pattern Hair Loss (See Appendix 1).\r\n\r\n          5. Subject must be Fitzpatrick Type I, II, III and IV skin pigmentation (See Appendix 2).\r\n             Type IV is acceptable however Type I-III is preferable.\r\n\r\n          6. Willing and able to comply with scheduled visits (Total: 7 visits in 48 weeks)\r\n\r\n          7. Willing to maintain the same hair style during the study period.\r\n\r\n          8. Willing to have a total of four microscopic dot tattoos. Two tattoos per treatment\r\n             site (one in the center and one on the edge) of the two target regions of the scalp at\r\n             miniaturization zone.\r\n\r\n          9. Willing to have 2 cm2 hairs clipped at treatment areas.\r\n\r\n         10. Willing to forgo the use of scalp products, including dye, throughout the study except\r\n             for study related dye.\r\n\r\n         11. Willing to use a mild, a non-ionic shampoo throughout the course of the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. History of keloid formation or hyperpigmentation.\r\n\r\n          2. A history of any acute or chronic illness that in the opinion of the investigators\r\n             might confound the results of the study including some drugs or medications.\r\n\r\n          3. Active skin diseases (e.g. eczema, atopic dermatitis, psoriasis, skin cancer, sun\r\n             damaged skin with actinic keratosis on scalp, etc.).\r\n\r\n          4. Routine high dosage use of anti-inflammatory medications (aspirin, ibuprofen,\r\n             corticosteroids), immunosuppressive drugs or antihistamine medications (steroid nose\r\n             drops and/or eye drops are permitted). Two 81 mg or one 325 mg aspirin per day is also\r\n             acceptable.\r\n\r\n          5. Use of topical drugs or other cosmetics on the scalp.\r\n\r\n          6. Immunological disorders such as HIV positive, alopecia areata, and systemic lupus\r\n             erythematosus.\r\n\r\n          7. Participation in any clinical study within the last four weeks.\r\n\r\n          8. Moderate or severe seborrheic dermatitis of scalp.\r\n\r\n          9. Damaged skin in or around test sites including sunburn, uneven skin tones, tattoos,\r\n             scars or other disfiguration of the test site.\r\n\r\n         10. Use of OTC (over-the-counter) or prescriptive topical or hair treatments, as well as\r\n             hair transplantation surgery during the last 6 months. This includes Minoxidil 2% or\r\n             5% and/or Finasteride 1mg or any 5alpha-reductase inhibitors.\r\n\r\n         11. Currently using hair system or wig.\r\n\r\n         12. Presence of hair transplants or scalp surgery.\r\n\r\n         13. History of allergy or intolerance to lidocaine and/or epinephrine.\r\n\r\n         14. Use of hair dye (not study related) during the study duration.\r\n\r\n         15. Any condition for which the Investigator determines that the subject could be placed\r\n             under undue risk.\r\n\r\n         16. Reported history of allergy or intolerance to bovine proteins.\r\n      ","sponsor":"Histogen","sponsor_type":"Industry","conditions":"Androgenetic Alopecia","interventions":[{"intervention_type":"Biological","name":"Biological: Hair Stimulating Complex (HSC)","description":"Study preparation (experimental) of 0.8 mL will be injected intradermally at Baseline and Week 6."},{"intervention_type":"Device","name":"Device: Dulbecco's Modified Eagle Medium, DMEM","description":"Study preparation (placebo comparator) of 0.8 mL will be injected intradermally at Baseline and Week 6."}],"outcomes":[{"outcome_type":"primary","measure":"Systemic safety measures will be assessed by measuring vital signs, adverse experiences, laboratory tests (hematology, clinical chemistry and urinalysis)and immunological response (anti-drug antibodies)","time_frame":"Clinically significant change from screening visit to Week 12"},{"outcome_type":"primary","measure":"Non-vellus hair counts","time_frame":"Change from Baseline to week 12 in treatment areas"},{"outcome_type":"secondary","measure":"Hair Thickness Density","time_frame":"Change from Baseline to week 48 in treatment areas"},{"outcome_type":"secondary","measure":"Local safety measures will be assessed by clinical exam of treatment areas and monitoring adverse events","time_frame":"Clinically significant change from Screening visit to Week 48"}]}
{"nct_id":"NCT01475682","start_date":"2011-11-30","enrollment":167,"brief_title":"Long Term Cardiovascular Complications in Men With Obstructive Sleep Apnea","official_title":"Long Term Cardiovascular Complications in Men With Obstructive Sleep Apnea - Prospective 9 Years Follow-up Study","primary_completion_date":"2015-05-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2015-05-31","last_update":"2014-07-17","description":"Subjects with Obstructive Sleep Apnea (OSA) are at increased risk of developing cardiometabolic complications, and effective long-term nCPAP treatment significantly reduces the risk of cardiovascular morbidity and mortality.","other_id":"UW 10-002","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"Male","minimum_age":18,"maximum_age":65,"population":"167 subjects recruited from our previous \"OSA and metabolic syndrome\" (OSAMS) cohort from\r\n        October 2002 to June 2007 will be invited to be reassessed at this time point.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  From previous cohort for reassessment.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Unstable medical conditions\r\n      ","sponsor":"The University of Hong Kong","sponsor_type":"Other","conditions":"Obstructive Sleep Apnea|Cardiovascular Diseases|Metabolic Diseases","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Incidence of cardiometabolic complications","time_frame":"9 years","description":"167 subjects recruited from our previous \"OSA and metabolic syndrome\" (OSAMS) cohort from October 2002 to June 2007 will be invited to be reassessed at this time point."},{"outcome_type":"secondary","measure":"Effects of CPAP treatment on cardiometabolic conditions","time_frame":"9 years"}]}
{"nct_id":"NCT01455935","start_date":"2011-11-30","phase":"Phase 2","enrollment":90,"brief_title":"Wake up Symptomatic Stroke - Benefit of Intravenous Clot Busters or Endovascular Intervention","official_title":"Wake up Symptomatic Stroke in Acute Brain Ischemia (WASSABI) Trial","primary_completion_date":"2013-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2014-02-28","last_update":"2012-03-30","description":"The purpose of the trial is to study the safety and the effectiveness of using CT Perfusion studies as an indicator to treat stroke patients with unknown time of onset.","other_id":"NEU 3200411A","allocation":"Randomized","intervention_model":"Factorial Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Inclusion Criteria: To be eligible for entry into this study, candidates must meet all of\r\n        the following eligibility criteria at the time of Emergency Department presentation:\r\n\r\n          1. Age: 18-80 years old\r\n\r\n          2. Ischemic Wake Up Stroke (Unknown time of onset but less than 24 hours since last seen\r\n             normal)\r\n\r\n          3. National Institute of Health Stroke Scale (NIHSS) 8-22\r\n\r\n          4. Evidence of penumbra on Computed Tomography Perfusion(CTP) as mentioned above\r\n\r\n          5. Alberta Stroke Program Early Computed Tomography (CT) Score (ASPECTS 7 or more)\r\n\r\n          6. Signed informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n        Exclusion Criteria: Potential study patients will be excluded from study entry if any of\r\n        the following exclusion criteria exist at the time of screening:\r\n\r\n          1. Evidence of intracranial hemorrhage (Intracerebral hematoma, intraventricular\r\n             hemorrhage, subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic\r\n             subdural hematoma (SDH)) on the baseline CT\r\n\r\n          2. Historical Modified Rankin Scale (mRS) of 2\r\n\r\n          3. National Institute of Health Stroke Scale (NIHSS)<8 at the time of treatment\r\n\r\n          4. Positive pregnancy test in women at age of childbearing\r\n\r\n          5. Intracranial or intraspinal surgery within 3 months\r\n\r\n          6. Stroke or serious head injury within 3 months\r\n\r\n          7. History of intracranial hemorrhage\r\n\r\n          8. Uncontrolled hypertension at time of treatment (eg, >185 mm Hg systolic or >110 mm Hg\r\n             diastolic)\r\n\r\n          9. Seizure at the onset of stroke\r\n\r\n         10. Active internal bleeding\r\n\r\n         11. Intracranial neoplasm\r\n\r\n         12. Arteriovenous malformation or aneurysm\r\n\r\n         13. Clinical presentation suggesting post-MI pericarditis\r\n\r\n         14. Known bleeding diathesis including but not limited to current use of oral\r\n             anticoagulants producing an Internation normalized ratio (INR) >1.7\r\n\r\n         15. Internation normalized ratio (INR) >1.7\r\n\r\n         16. Administration of heparin within 48 hours preceding the onset of stroke with an\r\n             elevated activated Partial Thromboplastin Time(aPTT) at presentation\r\n\r\n         17. Platelet count <100,000/mm\r\n\r\n         18. Major surgery within 2 weeks\r\n\r\n         19. GastroIntestinal (GI) or urinary tract hemorrhage within 3 weeks\r\n\r\n         20. Aggressive treatment required to lower blood pressure\r\n\r\n         21. Glucose level <50 or >400 mg/dL\r\n\r\n         22. Arterial puncture at a noncompressible site or lumbar puncture within 1 week\r\n      ","sponsor":"Jacobs Neurological Institute","sponsor_type":"Other","conditions":"Stroke","interventions":[{"intervention_type":"Drug","name":"Drug: Anti-platelets and statin"},{"intervention_type":"Drug","name":"Drug: alteplase","description":"Full dose Intravenous thrombolysis\r\n0.9 mg/kg\r\nMaximum dose is 90 mg\r\n10% of the dose will be given over one minute\r\n90% of the dose will be infused over 1 hour\r\nAdmission to Neuro Intensive Care Unit(NICU) for 24 hours if no complications\r\nNeuro checks every 5 minutes during the infusion\r\nNeuro checks every hour after the infusion for 24 hours"},{"intervention_type":"Procedure","name":"Procedure: intra arterial intervention","description":"Intra arterial Activase (Maximum dose of 22 mg)\r\nMERCI device (Maximum of 3 tries per device, no standard time frame for how long the procedure takes)\r\nPENUMBRA device (no standard time frame for how long the procedure takes)"}],"outcomes":[{"outcome_type":"secondary","measure":"National Institute of Health Stroke Scale (NIHSS)","time_frame":"24 hour","description":"National Institute of Health Stroke Scale (NIHSS) 24 hours post treatment."},{"outcome_type":"primary","measure":"Modified Rankin Scale (mRS)","time_frame":"90 days","description":"Modified Rankin Scale (mRS) 90 days post treatment"},{"outcome_type":"secondary","measure":"National Institute of Health Stroke Scale (NIHSS)","time_frame":"3-29 day","description":"National Institute of Health Stroke Scale (NIHSS) at discharge (3-29 days)"},{"outcome_type":"secondary","measure":"Modified Rankin Scale (mRS)","time_frame":"30 post treatment","description":"Modified Rankin Scale (mRS) at 30 days post treatment"},{"outcome_type":"secondary","measure":"Thrombolysis In Myocardial Infarction (TIMI) Flow","time_frame":"Pre - up to1 hour prior to procedure and post will be up to1 hour after completion of procedure","description":"Thrombolysis In Myocardial Infarction (TIMI) flow pre and post the intervention as an indicator of revascularization rate"},{"outcome_type":"secondary","measure":"Thomboylsis in Cerebral Ischemia (TICI) flow","time_frame":"Pre - will be no more than 1 hour prior to procedure and post will be no more then 1 hour after completion of procedure","description":"Thomboylsis in Cerebral Ischemia (TICI) flow pre and post intervention as an indicator of revascularization rate"},{"outcome_type":"secondary","measure":"symptomatic intracranial Hemorrhage (ICH)","time_frame":"72 hours","description":"Incidence of symptomatic symptomatic intracranial Hemorrhage (ICH) within 72 hours of intervention defined by ECASSIII as 4 points worsening in NIHSS"},{"outcome_type":"secondary","measure":"National Institute of Health Stroke Scale (NIHSS)","time_frame":"30 Days","description":"at 30 Day visit National Institute of Health Stroke Scale (NIHSS) will be assessed"}]}
{"nct_id":"NCT02221310","start_date":"2011-11-30","phase":"Phase 2","enrollment":25,"brief_title":"Immunochemotherapy and AlloSCT in Patients With High Risk CD33+ AML/MDS","official_title":"A Pilot Study of Gemtuzumab Ozogamicin in Combination With Busulfan and Cyclophosphamide (Immunochemotherapy) and Allogeneic Stem Cell Transplantation in Patients With High Risk Acute Myelogenous Leukemia and Myelodysplastic Syndrome","primary_completion_date":"2022-06-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2023-06-30","last_update":"2021-08-03","description":"Targeted immune therapy with gemtuzumab ozogamicin (Mylotarg) in combination with chemotherapy followed by allogeneic stem cell transplantation will be given to patients with high risk acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS).","other_id":"NYMC-515","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","maximum_age":25,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Disease Status:\r\n\r\n               -  History of AML Induction/Reinduction Failure\r\n\r\n               -  AML 1st Complete Remission (CR) with poor cytogenetics\r\n\r\n               -  AML 2nd CR with minimal residual disease (MRD)\r\n\r\n               -  AML 3rd CR\r\n\r\n               -  AML in refractory relapse but 25% bone marrow leukemia blasts\r\n\r\n               -  MDS with >6% bone marrow blasts at diagnosis\r\n\r\n               -  Secondary MDS with 5% bone marrow myeloblasts at diagnosis\r\n\r\n        Disease Immunophenotype:\r\n\r\n         Disease must express a minimum of >/= 10% CD33+ for patients with AML\r\n\r\n        Organ Function:\r\n\r\n         Adequate renal function, adequate liver function, adequate cardiac function, adequate\r\n        pulmonary function Age: 25 years of age Donor: matched family donor, unrelated cord blood\r\n        donor, unrelated adult donor\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with active central nervous system (CNS) AML/MDS disease at time of\r\n             conditioning therapy\r\n\r\n          -  Female patients who are pregnant\r\n\r\n          -  Karnofsky <50% or Lansky <50% if 10 years or less\r\n\r\n          -  Age >25 years\r\n\r\n          -  Has received gemtuzumab in the previous 30 days or has not recovered from prior\r\n             gemtuzumab therapy.\r\n      ","sponsor":"New York Medical College","sponsor_type":"Other","conditions":"Acute Myelogenous Leukemia|Myelodysplastic Syndrome","interventions":[{"intervention_type":"Drug","name":"Drug: Gemtuzumab Ozogamicin","description":"Gemtuzumab Ozogamicin 7.5 mg/m^2/dose given IV over 2 hours once during conditioning"}],"outcomes":[{"outcome_type":"primary","measure":"Response rate","time_frame":"1 year","description":"overall response rate (CR + PR) in patients receiving GO, busulfan and cyclophosphamide and AlloSCT in patients with measurable disease (relapse/refractory) with high risk CD33+ AML/MDS"}]}
{"nct_id":"NCT01863082","start_date":"2011-11-30","phase":"N/A","enrollment":28,"brief_title":"Resistant Hypertension and Physical Activity Performed in a Heated Pool","official_title":"Effects of Training in a Heated Pool in Patients With Refractory Hypertension","primary_completion_date":"2014-08-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2014-12-31","last_update":"2014-03-20","description":"patients with resistant hypertension will be submitted to an exercise protocol in a heated pool for three months","other_id":"2010/15649-4","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":40,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  patients with uncontrolled blood pressure despite concurrent use of 3 antihypertensive\r\n             agents, including a diuretic, or the need for more than 3 medications to control blood\r\n             pressure\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  poor adherence to the treatment\r\n\r\n          -  obesity\r\n\r\n          -  diabetes\r\n\r\n          -  smokers\r\n\r\n          -  secondary causes of hypertension\r\n\r\n          -  motor disabilities to perform the training\r\n      ","sponsor":"University of Sao Paulo","sponsor_type":"Other","conditions":"Hypertension, Resistant to Conventional Therapy","interventions":[{"intervention_type":"Other","name":"Other: exercise","description":"practice of physical exercise"}],"outcomes":[{"outcome_type":"primary","measure":"blood pressure value","time_frame":"Change from Baseline in Blood Pressure at 3 months","description":"participants will be followed for the duration of the exercise protocol, an expected average of 12 weeks"}]}
{"nct_id":"NCT02941276","start_date":"2011-11-30","phase":"Phase 3","enrollment":84,"brief_title":"A Trial Looking at Treating Dry Mouth After Radiotherapy for Head and Neck Cancer","official_title":"Long-term Evaluation of the Effectiveness Of a Novel Intra-oral Electro-stimulator for the Treatment of raDiotherapy-ASsociated Dry Mouth","primary_completion_date":"2014-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-11-30","last_update":"2017-05-18","description":"This trial is looking at using an intra-oral electrostimulating device for the management of radiotherapy-induced dry mouth.","other_id":"11/YH/0072","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. To be at least 18 years old\r\n\r\n          2. To have received more than 40 Gy of external beam RT for cancer in the H&N region at\r\n             least 4 months before entry into the study\r\n\r\n          3. To have grade 1 or 2 of RTOG/EORTC Late Radiation Morbidity Scoring Schema\r\n\r\n          4. To have a degree of minimum degree of dryness of 50mm (50mm) on a 100mm VAS scale\r\n             (0=no dryness 100\r\n\r\n             =maximum dryness).\r\n\r\n          5. To have demonstrable residual salivary gland function (increase in salivary flow on\r\n             appropriate stimulation (e.g. chewing paraffin wax)\r\n\r\n          6. To have at least one parotid gland\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. To have severe uncontrolled systemic disease (on the basis of the classification of\r\n             the American Society of Anesthesiology: ASA IV and ASA V)\r\n\r\n          2. To have known allergy to materials similar to those used in the investigational\r\n             product\r\n\r\n          3. To wear other active implants such as cardiac pacemaker or defibrillator, or hearing\r\n             aids\r\n\r\n          4. To have an unstimulated whole salivary flow of 0ml/15min (complete absence of\r\n             unstimulated salivary flow as measured via sialometry for 15 minutes).\r\n\r\n          5. To use of pilocarpine as systemic therapy\r\n\r\n          6. To have grade 3 RTOG/EROTC or no resting saliva (sialometry = 0mL/1.5 min)\r\n\r\n          7. To have no parotid glands\r\n      ","sponsor":"University College, London","sponsor_type":"Other","conditions":"Xerostomia|Head and Neck Neoplasms","interventions":[{"intervention_type":"Device","name":"Device: Active Electrostimulator device","description":"Patients who will receive a fully functioning device"},{"intervention_type":"Device","name":"Device: Sham Electrostimulator device","description":"Patients who will receive a device that does not release electric stimuli (but provided mechanical/tactile stimulation)"}],"outcomes":[{"outcome_type":"primary","measure":"Improvement of subjective perception of dry mouth as measured on the Visual Analog Scale","time_frame":"12 month","description":"The primary outcome is defined as the proportion of patients reporting a 30% reduction of xerostomia symptoms as evaluated through a 100mm VAS (100mm=maximum dryness)."},{"outcome_type":"secondary","measure":"Improvement of objective salivary function as measured through 5-minutes sialometry","time_frame":"12 month"},{"outcome_type":"secondary","measure":"Improvement in head and neck quality of life as measured on the EORTC QLQ-H&N35","time_frame":"12 month"},{"outcome_type":"secondary","measure":"Improvement in oral health quality of life as measured on the OH-QoL16 questionnaire","time_frame":"12 month"},{"outcome_type":"secondary","measure":"Improvement in general quality of life as measured on the SF-36 questionnaire","time_frame":"12 month"},{"outcome_type":"secondary","measure":"Evaluation of patients' tolerance in using the device by using a diary to record daily measurement.","time_frame":"12 month"}]}
{"nct_id":"NCT01413542","start_date":"2011-11-30","phase":"N/A","enrollment":44,"brief_title":"Pharmacogenetics of Ace Inhibitor-Associated Angioedema","official_title":"Pharmacogenetics of Ace Inhibitor-Associated Angioedema:Aim 1","primary_completion_date":"2013-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-07-31","last_update":"2015-11-04","description":"The investigators would like to find out if sitagliptin (dipeptidyl peptidase-4 or DPP4 inhibition), a drug to treat diabetes, affects blood vessel relaxation in healthy people receiving enalapril (angiotensin converting enzyme or ACE inhibition), a blood pressure medicine. Understanding how these drugs interact in healthy people will help us learn their potential effects in people who have diabetes.","other_id":"HL079184","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age 18 to 65 inclusive\r\n\r\n          -  Men and women\r\n\r\n          -  Black and White Americans\r\n\r\n          -  BMI <25\r\n\r\n        For female subjects:\r\n\r\n          -  Postmenopausal status for at least 1 year\r\n\r\n          -  Status post surgical sterilization\r\n\r\n          -  If childbearing potential, utilization of a barrier method of birth control and\r\n             willingness to undergo blood B-hcg testing prior to drug treatment and on every study\r\n             day\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Smoking\r\n\r\n          -  Diabetes type 1 or 2, as defined by a fasting glucose of 126 mg/dl or greater or the\r\n             use of anti-diabetic medication\r\n\r\n          -  Hypertension as defined by an untreated seated SBP greater than 140 mmHg an untreated\r\n             DBP greater than 90 mmHg or the use of antihypertensives\r\n\r\n          -  History of reported or recorded hypoglycemia (plasma glucose less than 70 mg/dl)\r\n\r\n          -  Pregnancy\r\n\r\n          -  Breast-feeding\r\n\r\n          -  Use of hormone replacement therapy\r\n\r\n          -  The use of contraceptive therapy\r\n\r\n          -  Use of any medication other than multivitamin\r\n\r\n          -  Hematocrit <35%\r\n\r\n          -  Cardiovascular disease such as history of myocardial infarction, presence of angina\r\n             pectoris, significant arrhythmia, congestive heart failure(LV hypertrophy acceptable),\r\n             deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral\r\n             valve stenosis, aortic stenosis or hypertrophic cardiomyopathy\r\n\r\n          -  Asthma\r\n\r\n          -  History of angioedema\r\n\r\n          -  History of cough or other side effect during ACE inhibitor use\r\n\r\n          -  Impaired renal function, as defined by an eGFR<60ml/min/1.73M2\r\n\r\n          -  Clinically significant gastrointestinal impairment that could interfere with drug\r\n             absorption\r\n\r\n          -  Impaired hepatic function (aspartate amino transaminase[AST] and/or alanine amino\r\n             transferase [ALT]>2 x upper limit of normal range\r\n\r\n          -  History of alcohol or drug abuse\r\n\r\n          -  Treatment with any investigational drug in the 1 month preceding the study\r\n\r\n          -  Mental conditions rendering the subject unable to understand the nature, scope and\r\n             possible consequences of the study\r\n\r\n          -  Inability to comply with the protocol, e.g., uncooperative attitude, inability to\r\n             return to follow-up visits, and the unlikelihood of completing the study\r\n      ","sponsor":"Vanderbilt University","sponsor_type":"Other","conditions":"Hypertension|Diabetes Type 2","interventions":[{"intervention_type":"Drug","name":"Drug: Sitagliptin (DPP4 inhibitor)","description":"Sitagliptin 200 mg (DPP4 inhibitor) or matching placebo will be given one hour prior to intra-arterial infusions"},{"intervention_type":"Drug","name":"Drug: Substance P,","description":"Substance P intra-brachial artery (2,4,8 pmol/min)"},{"intervention_type":"Drug","name":"Drug: bradykinin","description":"bradykinin intra-brachial artery (23.6, 47.2, and 94.3 pmol/min)"},{"intervention_type":"Drug","name":"Drug: enalaprilat (ACE inhibitor)","description":"intra-brachial artery(0.33 g/min per 100 mL forearm volume)"},{"intervention_type":"Drug","name":"Drug: Glucagon-like peptide 1","description":"intra-brachial artery (0.45-3.60 pmol/min)"},{"intervention_type":"Drug","name":"Drug: brain natriuretic peptide","description":"Intra-brachial artery (0.90, 1.80 and 3.6 pmol/min)"}],"outcomes":[{"outcome_type":"primary","measure":"The Effect of Enalaprilat (ACE Inhibition), Sitagliptin (DPP4 Inhibition), or the Combination on the Vasodilator Response (Forearm Blood Flow) to Substance P (SP) and Bradykinin (Group 1) or Glucagon Like Peptide-1 and Brain Naturetic Peptide (Group 2).","time_frame":"60 minutes post-placebo or sitagliptin (DPP4 inhibition) and over last 2 minutes of each 5 min infusion per peptide dose (30 min washout between peptides); sequence repeated with enalaprilat (ACE inhibition) or vehicle","description":"Forearm blood flow (FBF) was measured by strain gauge plethysmography at the completion of each dose of intra-arterial peptide. A dose response curve was therefore constructed for each vasoactive peptide substrate. The effect of sitagliptin (DPP4 inhibition) vs. placebo and enalaprilat (ACE inhibition) vs. vehicle on the forearm blood flow response to each peptide could then be determined."},{"outcome_type":"secondary","measure":"Assess Tissue Type Plasminogen Activator (tPA) Release","time_frame":"Blood for analysis of tPA release was obtained 60 minutes after sitagliptin (DPP4 inhibition) vs. placebo and after each assessment of FBF (see primary outcome measure)","description":"Following measurement of FBF, samples will be obtained to determine the effect of ACE inhibition and/or DPP4 inhibition on tPA release in response to bradykinin and substance P (SP) (group 1)"},{"outcome_type":"secondary","measure":"Assess Effect of ACE and/or DPP4 Inhibition on Heart Rate Response to Substance P (SP)","time_frame":"Heart rate was measured every 5 minutes throughout the study day (and thus during each dose of peptide infusion)"},{"outcome_type":"secondary","measure":"Effect of Treatment (ACE or DPP4 Inhibition, or Combined) on Norepinephrine (NE) Release (Arterial Venous Gradient) in Response to Substance P (SP)","time_frame":"Blood for analysis of norepinephrine (NE) release was obtained 60 minutes after sitagliptin (DPP4 inhibition) vs. placebo and after each assessment of FBF (see primary outcome measure)"},{"outcome_type":"secondary","measure":"Effect of Treatment (DPP4 Inhibition vs. Placebo) on Venous GLP-1 Levels in Response to Arterial GLP-1 Infusion","time_frame":"Blood for analysis of GLP-1 levels was obtained one hour after sitagliptin (DPP4 inhibition) vs. placebo administration and after each dose of GLP-1"}]}
{"nct_id":"NCT02398097","start_date":"2011-11-30","phase":"Phase 4","enrollment":88,"brief_title":"Conventional Vaccine and Intradermal Vaccine Among HIV-infected Young Subjects","official_title":"Safety and Immunogenicity of Influenza Vaccine Among HIV-infected Young Subjects: Conventional Vaccine Versus Intradermal Vaccine","primary_completion_date":"2011-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-04-30","last_update":"2015-03-25","description":"Several studies have shown poor immune response to conventional influenza vaccines in HIV-infected individuals. This study was conducted expecting the more potent immunogenicity of intradermal vaccine compared with conventional intramuscular vaccine in HIV-infected adults.","other_id":"FLUHIV","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  HIV-infected individuals who were not immunized with 2011/2012 influenza vaccine\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  known allergy to egg\r\n\r\n          -  presentation of any febrile illness 37.5C on the day of vaccination\r\n\r\n          -  any history of hypersensitivity reaction to previous influenza vaccination\r\n\r\n          -  any other vaccinations within the past one month\r\n\r\n          -  use of immunosuppressive agent\r\n\r\n          -  recipient of blood product or immunoglobulins during the previous three months\r\n\r\n          -  any other conditions that might interfere with the study results\r\n      ","sponsor":"Korea University Guro Hospital","sponsor_type":"Other","conditions":"Human Influenza","interventions":[{"intervention_type":"Biological","name":"Biological: IDflu9g","description":"2011/2012 influenza season reduced-content intradermal split vaccine, single dose"},{"intervention_type":"Biological","name":"Biological: IDflu15g","description":"2011/2012 influenza season standard-content intradermal split vaccine, single dose"},{"intervention_type":"Biological","name":"Biological: Agripal","description":"2011/2012 influenza season standard dose trivalent subunit inactivated intramuscular vaccine, single dose"}],"outcomes":[{"outcome_type":"primary","measure":"The proportion of participants with a post-vaccination titer ≥1:40 in subjects with a pre-vaccination titer of <1:10 or a ≥4-fold titer increase in subjects with a pre-vaccination titer of ≥1:10","time_frame":"Outcome measure was assessed at two points (baseline and 4 weeks after vaccination)"},{"outcome_type":"secondary","measure":"Percentage of subjects with a post-vaccination titer ≥1:40","time_frame":"Outcome measure was assessed 4 weeks after vaccination"},{"outcome_type":"secondary","measure":"GMT ratio of the post-vaccination titer to pre-vaccination titer","time_frame":"Outcome measure was assessed at two points (baseline and 4 weeks after vaccination)"},{"outcome_type":"other","measure":"Frequency and duration of local and systemic adverse events","time_frame":"Adverse events were recorded for 7 days.","description":"The diary was made based on the Food and Drug Association (FDA) Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials"}]}
{"nct_id":"NCT01966562","start_date":"2011-11-30","phase":"N/A","enrollment":69,"brief_title":"PAHA Study: Psychological Active and Healthy Ageing","official_title":"Psychological Well Being, Proactive Attitude and Happiness Effects of Whole-body Vibration vs. Multi-component Training in Aged Women: a Randomized Controlled-trial Study Protocol","primary_completion_date":"2012-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-07-31","last_update":"2013-10-21","description":"The PAHA study is a three-arm randomized controlled clinical trial (RCT). The aim of this RCT is to compare the effectiveness of the WHOLE-BODY VIBRATION (WBV) with the Multi-component training control group and control group (CG) for psychological well being, quality of life, proactive attitude and happiness in female aged subjects.","other_id":"NCT002899231","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"Female","minimum_age":55,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Women;\r\n\r\n          -  Age ranged between 55-75 years old.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Male sex;\r\n\r\n          -  Age lower than 55 years old;\r\n\r\n          -  Present levels of DMO lower than 70 g/cm2;\r\n\r\n          -  Being treated for a disease that can affect bone structure or neuromuscular system;\r\n\r\n          -  Have orthopedic prosthetic implants in the lower limbs and / or spine; Have herniated\r\n             discs;\r\n\r\n          -  Suffer ocular diseases that affect the retina;\r\n\r\n          -  Suffer severe cardiovascular diseases;\r\n\r\n          -  Have a pacemaker, or osteosynthesis material;\r\n\r\n          -  Severe mental illness (active psychosis/suicide risk/severe dementia);\r\n\r\n          -  Linguistic limitations (such as stuttering/untreated audio impairment);\r\n\r\n          -  A significant functional problem (such as unconsciousness/connection to respiration\r\n             device/confinement to a wheelchair or bed/severe walking disability/need of help with\r\n             basic daily activities), major depression, anxiety according to DSM-IV criteria.\r\n      ","sponsor":"University of Bergamo","sponsor_type":"Other","conditions":"Aged","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: WHOLE-BODY VIBRATION TRAINING","description":"The vibration stimulus consisted of uniform vertical oscillations Power Plate Next Generation (Power Plate North America, Northbrook, IL, USA). Subjects stood on the platform holding an quarter squat positions with the feet shoulder-width apart. Then, they perform ankle extensions with the following work sequence (establishing a rhythm of 100 b.p.m.: 1 b.p.m for the concentric phase; and 5 b.p.m. for the eccentric phase). After the familiarization 2-weeks, subjects trained 3 days per week for 6-months (72 sessions) using a vibrating training program that began with 5 sets and a frequency of 35 Hz per session and increasing by 11 sets and 40 Hz frequency the last month maintaining a series of parameters: vibration amplitude (4 mm) working time (60 s) and recovery time (60 s)."},{"intervention_type":"Behavioral","name":"Behavioral: MULTICOMPONENT TRAINING","description":"This training combined vertical jumps and high intensity walking. During the first month, small reactive vertical jumps (without knee and ankle flexion) were performed. After the first month, subjects performed drop jumps progressively starting at a height of 5 cm and finishing at 25 cm at the end of the programme (increases of 5 cm each month). Additionally, the sets were increased from 4x10 jumps to 6x10 each week, finishing the last week with 4x10. In this sense, the drop jumps were the same each month but the total load (imposed by height) increased progressively. Regarding the aerobic exercise, the load increased progressively along the 6 months. The intensity ranged between 50-75% of reserve heart rate, the volume ranged between 30-60 min."}],"outcomes":[{"outcome_type":"primary","measure":"Psychological General Well-Being Index (PGWBI)","time_frame":"Within one year after the treatment","description":"The PGWBI. It is a self-administered test with 22 items that assess the subjective sensation of psychological wellbeing. It has been divided in 6 categories: anxiety, depression, self-control, positivity and wellbeing, health and vitality (Grossi et al., 2006)."},{"outcome_type":"secondary","measure":"Subjective Happiness Scale (SHS)","time_frame":"Within one year after the treatment","description":"It 4-item scale for assessing subjective happiness. Two items ask respondents to characterize themselves using both absolute ratings and ratings relative to peers, whereas the other two items offer brief descriptions of happy and unhappy individuals and ask respondents the extent to which each characterization describes them. The SHS has been validated in 14 studies with a total of 2,732 participants. Preliminary results have indicated that the SHS has high internal consistency, which has been found to be stable across samples. Test-retest and self-peer correlations have suggested good to excellent reliability, and construct validation studies of convergent and discriminant validity have confirmed the use of this scale to measure the construct of subjective happiness (Lyubomirsky & Lepper, 1999)."},{"outcome_type":"secondary","measure":"Proactive Attitude Scale (PA)","time_frame":"Within one year after the treatment","description":"It assess the presence of a Proactive Attitude that is a relatively persistent personal belief in the rich potential of changes that can be made to improve oneself and one's environment. The proactive attitude has implications for motivation and action. This includes various facets such as resourcefulness, responsibility, values and vision. The psychological construct of Proactive Attitude (PA) present a correlation of r = .56 with general self-efficacy (Schwarzer, 1999)"},{"outcome_type":"secondary","measure":"SF-12 Health Survey","time_frame":"Within one year after the treatment","description":"It is a self-administered test that assesses the global health status by the subjective point of view of the subject. It has been divided into two principal subscales: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). In particular, it allows to asses concept concerning health, physical functions, pain, general health, vitality, social functioning, emotional functioning and mental health (Kodraliu et al., 2001)."}]}
{"nct_id":"NCT01469026","start_date":"2011-11-30","phase":"Phase 4","enrollment":220,"brief_title":"CUP Project PET/CT","official_title":"The Value of Early PET/CT in Patients With Metastasising Cancer of Unknown Primary","primary_completion_date":"2013-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2014-12-31","last_update":"2011-11-10","description":"The purpose is to elucidate the value of PET/CT applied early in the work-up of patients with a metastasising cancer of an unknown primary tumor. The management of patients with metastasising cancer of unknown primary often includes various and a large number of radiographic studies and invasive procedures, but the occult primary tumor is detected in less than 20%. Early PET/CT may be useful in Cancer of Unknown Primary (CUP) before expensive and invasive diagnostic procedures are carried out. The outcome may be higher tumor detection rate and quicker diagnosis, avoiding unnecessary, extensive procedures. Furthermore, a large number of the patients will receive treatment aimed at the correct diagnosis. Therefore, a prospective cost-effectiveness analysis is warranted.","other_id":"K36","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Diagnostic","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Biopsy proven cancer without identified origin at the time of examination.\r\n\r\n          2. Patients admitted to but not fitting into existing cancer package programs.\r\n\r\n          3. Patients with very serious, but unknown, disease, which might be cancer.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patient belongs to one of the existing cancer packages - state which one.\r\n\r\n          2. Suspected metastasis in the liver.\r\n\r\n          3. Suspected metastasis in the brain.\r\n\r\n          4. Prior PET/CT imaging showing multiple metastases with no identifiable primary.\r\n\r\n          5. Cancer treatment already started.\r\n\r\n          6. Estimated inability to collaborate - state reason.\r\n\r\n          7. Prior malignant disease.\r\n\r\n          8. Pregnancy.\r\n\r\n          9. The patient cannot read and understand Danish.\r\n      ","sponsor":"Odense University Hospital","sponsor_type":"Other","conditions":"Metastasising Cancer of Unknown Primary","interventions":[{"intervention_type":"Radiation","name":"Radiation: PET/CT or Conventional diagnostics including CT","description":"Radiation:\r\nPET/CT. 4 MBq/kg (max. 400 MBq) 18F-flour-deoxyglucosegiven iv. 60 min. before PET/CT scan.\r\nCT. iv.contrast medium (Ultravist 370 mg I/ml)."}],"outcomes":[{"outcome_type":"primary","measure":"1. Detection of primary tumor possible: yes/no (primary endpoint)","time_frame":"Up to 24 hours","description":"The outcome is evaluated based on the project specified PET/CT compared to conventional diagnostic investigations including CT. - The evaluation of the PET/CT scan, primary tumor/non-primary tumor, is obtained by consensus of two nuclear medicine physicians with experience in PET/CT."},{"outcome_type":"secondary","measure":"2. Time frame from inclusion into the study to detection of primary tumor.","time_frame":"Up to 1 week","description":"The time frame is determined by the number of days from the date of inclusion to the date of description for the PET/CT or the date of description for conventional CT."},{"outcome_type":"secondary","measure":"3. Time frame from inclusion into the study to referral to palliative or curative treatment.","time_frame":"Up to 4 weeks","description":"The time frame is determined by the number of days from the date of inclusion to the date of description for the PET/CT or the date of description for conventional CT."},{"outcome_type":"secondary","measure":"4. Time frame from inclusion into the study to end of follow-up or death.","time_frame":"36 months","description":"Patients are followed till death or 36 months post inclusion."},{"outcome_type":"secondary","measure":"5. Total score of Quality of Life instrument \"SF-36\".","time_frame":"36 months","description":"Quality of life evaluation is performed at 3-6-12 and 36 months."}]}
{"nct_id":"NCT01482039","start_date":"2011-11-30","phase":"N/A","enrollment":210,"brief_title":"Patient Attitudes Toward Ultrasound Measurement of Cervical Length","official_title":"Patient Attitudes Regarding Abdominal Versus Transvaginal Ultrasonography for Assessment of the Cervical Length in Low Risk Patients: a Randomized Trial","primary_completion_date":"2012-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2012-12-31","last_update":"2011-11-30","description":"The investigators propose a prospective evaluation of methods to assess cervical length for uncomplicated singleton gestations between 18-28 weeks presenting to the MFM office for routine mid pregnancy ultrasound. The investigators hypothesize that a sequential approach to screening of the cervix (which consists of initial transabdominal evaluation first with transvaginal ultrasound reserved only for those patients in whom the cervix appears short on transabdominal exam or when adequate views cannot be obtained with the transabdominal approach alone) will take less time, will result in the same number of adequate views of the cervix and will have higher patient satisfaction that a universal transvaginal screening approach. OBJECTIVE To determine the best strategy for cervical length screening in uncomplicated singleton gestations between the gestational ages of 18-28 weeks. Primary outcome: 1) Time required to obtain adequate views of the cervical length. Secondary outcomes: 1. Patient satisfaction with ultrasound experience as measured by patient questionnaire 2. Number of adequate views of the cervix obtained with each approach STUDY DESIGN This is a prospective study to compare strategies for cervical length measurements in uncomplicated singleton gestations seen in the MFM office for routine mid pregnancy fetal well being ultrasound between 18-28 weeks gestation. The different strategies include 1) Transabdominal assessment of the cervix (current standard), 2) Sequential evaluation of the cervical length (transabdominal followed by transvaginal if necessary due to short cervix or inadequate transabdominal views), and 3) Transvaginal cervical length assessment. Patients with an uncomplicated singleton gestation presenting for a routine mid pregnancy ultrasound between 18-28 weeks will be randomized into one of the three groups noted above after consent is obtained. Ultrasound examination will then take place and data collected. The various strategies listed above will be compared for the following: 1. Time required to obtain views of the cervix 1. Time from initiation of exam to completion of cervical assessment 2. Time for completion of entire exam 2. Patient satisfaction 1. Comfort/Discomfort of exam procedure 2. Overall impression of exam process 3. Number of adequate views of the cervix obtained Maternal demographics including age, parity, weight, height and due date/gestational age will also be obtained for all consenting patients.","other_id":"Sonographic Cervical Length","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Screening","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  singleton gestation\r\n\r\n          -  between 18-28 weeks\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  presence of cerclage\r\n\r\n          -  known short cervix\r\n\r\n          -  prior preterm birth\r\n      ","sponsor":"Intermountain Women and Children's Research","sponsor_type":"Other","conditions":"Cervical Insufficiency","interventions":[{"intervention_type":"Procedure","name":"Procedure: Sequential ultrasound","description":"Abdominal ultrasound first; obtain 3 adequate measurements. If 3 adequate views not obtained or if measurement less than 3 cm, perform transvaginal ultrasound for measurement."},{"intervention_type":"Procedure","name":"Procedure: Transvaginal ultrasound","description":"Obtain 3 transvaginal ultrasound cervical length measurements"}],"outcomes":[{"outcome_type":"primary","measure":"Time","time_frame":"Assessed on the day of ultrasound (one single visit)","description":"The time it takes to perform the assessment of the cervix will be recorded, as well as the time it takes to perform the entire exam."},{"outcome_type":"secondary","measure":"Patient satisfaction","time_frame":"Assessed the day of the ultrasound (one single visit)","description":"Participants will complete a survey indicating their opinions about the ultrasound experience."},{"outcome_type":"secondary","measure":"Ultrasound adequacy","time_frame":"Assessed on the day of the ultrasound (one single visit)","description":"Assess the frequency with which adequate views of the cervix can be obtained using transabdominal vs transvaginal ultrasonography"}]}
{"nct_id":"NCT01646697","start_date":"2011-11-07","phase":"N/A","enrollment":90,"brief_title":"Slide Interpretation or Standard Surgical Pathology in Assessing Margin Status in Patients With Pancreatic Cancer Undergoing Surgery","official_title":"Cytopathologic Margin Evaluation in Patients Undergoing Pancreatic Cancer Resection","primary_completion_date":"2016-02-06","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-02-06","last_update":"2017-06-09","description":"This study is being done to investigate another way of evaluating margin status after pancreatectomy by using cytopathology (slide interpretation) as compared to the traditional method of surgical pathology","other_id":"OSU-10110","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  patients undergoing pancreatic resection for a presumed, although not necessarily\r\n             biopsy-proven pancreatic malignancy,\r\n\r\n          -  ages 18 years to 80 years old\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnant women\r\n      ","sponsor":"Ohio State University Comprehensive Cancer Center","sponsor_type":"Other","conditions":"Pancreatic Cancer|Adenocarcinoma","interventions":[{"intervention_type":"Other","name":"Other: cytology specimen collection procedure","description":"Undergo cytopathologic sample collection"}],"outcomes":[{"outcome_type":"primary","measure":"Local recurrence at the site of resection","time_frame":"up to 2 years","description":"Will be evaluated in a Cox proportion hazards regression model. The prognostic ability of the histological reporting of the specimen margin as well as the cytopathological reporting of the specimen and in situ margins will be evaluated."}]}
{"nct_id":"NCT01469845","start_date":"2011-10-31","phase":"Phase 3","enrollment":300,"brief_title":"The SABRE Trial of Hypertonic Saline in Acute Bronchiolitis","official_title":"Hypertonic Saline in Acute Bronchiolitis: Randomised Controlled Trial and Economic Evaluation","primary_completion_date":"2013-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-01-31","last_update":"2015-03-25","description":"Acute bronchiolitis is a common, distressing illness affecting children. A virus infects the lungs, and then the airways become blocked, leading to difficulties with breathing. It is the most common reason why children are admitted to hospital, with 1-3% of all children admitted to hospital during their first winter, creating enormous strains on NHS services. The majority of those admitted with the condition are under six months of age and the associated stress for parents is considerable. After forty years of research the best treatment we have is supportive care and oxygen. Recent research suggests that salt water, sprayed as a mist so that the children can breathe it in ('nebulised 3% hypertonic saline') might help children with acute bronchiolitis. Scientists think that the salt water changes the mucus which blocks the airways so that it can be cleared more easily. Three small research studies all suggested that a child's time in hospital could be reduced by a quarter by using this treatment. If this was true, it would be good for children, their families and the children's wards trying to cope with the large numbers admitted with bronchiolitis every year. To decide whether this treatment should be used throughout the NHS, we need to run a randomised controlled trial of hypertonic saline in a large number of children. The trial will tell us if adding saline to usual care reduces distress in both children and parents, as well as whether it reduces the length of time they stay in hospital. We will then know if the treatment is the best thing for children with bronchiolitis and whether it provides the NHS with good value for money.","other_id":"SCH/1/016","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","maximum_age":1,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Previously healthy infants under 1 year of age\r\n\r\n          -  Admitted to hospital with a clinical diagnosis of acute bronchiolitis, following the\r\n             UK definition of an infant with an apparent viral respiratory tract infection\r\n             associated with airways obstruction manifest by hyperinflation, tachypnoea and\r\n             subcostal recession with widespread crepitations on auscultation\r\n\r\n          -  Requiring supplemental oxygen therapy on admission\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Wheezy bronchitis or asthma - children with an apparent viral respiratory infection\r\n             and wheeze with no or occasional crepitations\r\n\r\n          -  Previous lower respiratory tract infections\r\n\r\n          -  Risk factors for severe disease [gestation <32 weeks, immunodeficiency, neurological\r\n             and cardiac conditions, chronic lung disease]\r\n\r\n          -  Subjects where the carer's English is not fluent and translational services are not\r\n             available\r\n\r\n          -  Requiring admission to high dependency or intensive care units at the time of\r\n             recruitment\r\n      ","sponsor":"Sheffield Children's NHS Foundation Trust","sponsor_type":"Other","conditions":"Acute Bronchiolitis","interventions":[{"intervention_type":"Device","name":"Device: 3% hypertonic saline","description":"4 ml dose to be administered every 6 hours"}],"outcomes":[{"outcome_type":"primary","measure":"Time to 'fit for discharge'","time_frame":"This was judged to be when the infant was feeding adequately [taking >75% of usual intake] and was in air with a saturation of at least 92% for 6 hours, to reflect clinical practice.","description":"The primary objective was an analysis, to show if the addition of 3% hypertonic saline to usual care results in significant [25%] reduction in the duration of hospitalisation of infants admitted with acute bronchiolitis. This outcome was measured at 6 hourly intervals, with the first evaluation at time of randomisation."},{"outcome_type":"secondary","measure":"Actual time to discharge","time_frame":"This was measured from time to randomisation to the discharge time according to routine clinical guidelines.","description":"The secondary objectives were assessments of the economic impact of such an intervention on both the NHS and parents, as well as quality of life and other health related outcomes assessed 28 days after entry to the study."},{"outcome_type":"secondary","measure":"Readmission","time_frame":"Within 28 days from randomisation","description":"The secondary objectives were assessments of the economic impact of such an intervention on both the NHS and parents, as well as quality of life and other health related outcomes assessed 28 days after entry to the study."},{"outcome_type":"secondary","measure":"health care utilisation","time_frame":"post-discharge and within 28 days from randomisation","description":"The secondary objectives were assessments of the economic impact of such an intervention on both the NHS and parents, as well as quality of life and other health related outcomes assessed 28 days after entry to the study"},{"outcome_type":"secondary","measure":"duration of respiratory symptoms","time_frame":"post discharge and within 28 days from randomisation","description":"The secondary objectives were assessments of the economic impact of such an intervention on both the NHS and parents, as well as quality of life and other health related outcomes assessed 28 days after entry to the study"},{"outcome_type":"secondary","measure":"Infant and parental quality of life using the Infant Toddler Quality of Life (ITQoL) questionnaire","time_frame":"28 days following randomisation.","description":"The secondary objectives were assessments of the economic impact of such an intervention on both the NHS and parents, as well as quality of life and other health related outcomes assessed 28 days after entry to the study"}]}
{"nct_id":"NCT01446731","start_date":"2011-10-31","phase":"Phase 2","enrollment":43,"brief_title":"Dendritic Cell Vaccination and Docetaxel for Patients With Prostate Cancer","official_title":"Dendritic Cell Vaccination in Combination With Docetaxel for Patients With Cancer Prostate - a Randomized Phase II Study","primary_completion_date":"2015-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-08-31","last_update":"2016-08-16","description":"This is a randomized phase II trial including 40 patients with castration resistant metastatic cancer prostate (CRMPC). Patients will be randomized between treatment with a dendritic cell vaccine plus docetaxel and docetaxel alone. The primary objective is to evaluate the vaccine specific immune response and patients will be evlauated with blood tests and DTH reactions during the treatment course. Secondary objectives are to evaluate clinical response by objective response (RECIST-criteria, 18F-NaF-PET/CT scan), PSA response, pain response and finally we determine time to progression and overall survival.","other_id":"UR1121","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Histological verified CRMPC in progression, defined by\r\n\r\n               1. RECIST-criteria and/or\r\n\r\n               2. PSA increase to more than baseline in two consecutive measurements\r\n\r\n          2. Treatment with Docetaxel is indicated\r\n\r\n          3. Age > 18 years old\r\n\r\n          4. ECOG performance status 2\r\n\r\n          5. Life expectancy > 3 months\r\n\r\n          6. Normal organ function\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Other malignant tumors\r\n\r\n          2. Severe heard or lung disorders\r\n\r\n          3. Infection with HIV, hepatitis, tuberculosis.\r\n\r\n          4. Severe allergy or previous anaphylactic reactions\r\n\r\n          5. Active autoimmune disease\r\n\r\n          6. Treatment with immunosuppressive drugs (including prednisolon, methotrexat)7.\r\n             Co-treatment with other experimental treatments, other antineoplastic treatment.\r\n      ","sponsor":"Inge Marie Svane","sponsor_type":"Other","conditions":"Prostatic Neoplasms","interventions":[{"intervention_type":"Biological","name":"Biological: mRNA transfected dendritic cell","description":"Autologues monocytes are matured into dendritic cells which are then transfected with mRNA from PSA, PAP, survivin and hTERT.\r\n5x 10e6 DCs are given as intradermal injections in the groin Day 8 and Day 15 in a 3 week period repeated 4 times and thereafter Day 8 in a 3 week period until progression (no maximum duration)."},{"intervention_type":"Drug","name":"Drug: Docetaxel","description":"Docetaxel 75 mg/m2 is given as an intravenous injection Day 1 every three weeks in a maximum of 12 cycles (1 cycle = 3 weeks)."}],"outcomes":[{"outcome_type":"primary","measure":"Immunological response","time_frame":"2 years","description":"The induction of vaccine specific immune responses will be assessed"},{"outcome_type":"secondary","measure":"Clinical response","time_frame":"2 years","description":"Clinical response will be assessed using PSA measurements, pain response and PET/CT scans (according to RECIST)"},{"outcome_type":"secondary","measure":"Toxicity","time_frame":"2 years"},{"outcome_type":"secondary","measure":"Time to progression","time_frame":"4 years"},{"outcome_type":"secondary","measure":"Overall survival","time_frame":"4 years"}]}
{"nct_id":"NCT01456091","start_date":"2011-10-31","phase":"N/A","enrollment":954,"brief_title":"Evaluation of the Efficacy of the AIM (Adult Identity Mentoring) 4 Teen Moms Program","official_title":"Evaluation of the Efficacy of the AIM (Adult Identity Mentoring) 4 Teen Moms Program","primary_completion_date":"2016-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-01-31","last_update":"2016-03-22","description":"The purpose of this study is to evaluate the efficacy of the AIM 4 Teen Moms program in increasing the use of long-term contraceptives, in improving adherence to contraceptives and in preventing rapid repeat pregnancies among parenting adolescents.","other_id":"MPR06549-2","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":15,"maximum_age":19,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Beneficiaries of California's Adolescent Family Life or Cal-Learn programs in the Los\r\n             Angeles County area\r\n\r\n          -  Female\r\n\r\n          -  15 - 19 years old\r\n\r\n          -  Has a child between the ages 1 and 6 months at program start\r\n\r\n          -  English or Spanish speaker\r\n      ","sponsor":"Mathematica Policy Research, Inc.","sponsor_type":"Other","conditions":"Pregnancy","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: AIM 4 Teen Moms","description":"The AIM (Adult Identity Mentoring) 4 Teen Moms program is a combination of individual and small group sessions intervention that encourages parenting young women ages 15-19 years old to delay rapid repeat pregnancies for 24 months or later."}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of repeat pregnancy","time_frame":"24 months after baseline"},{"outcome_type":"secondary","measure":"Adherence to contraception","time_frame":"12 months after baseline"},{"outcome_type":"secondary","measure":"Adherence to contraception","time_frame":"24 months after baseline"}]}
{"nct_id":"NCT01733485","start_date":"2011-10-31","phase":"Phase 1","enrollment":50,"brief_title":"Electrophilic Fatty Acid Derivatives in Asthma","official_title":"Electrophilic Fatty Acid Derivatives in Asthma","primary_completion_date":"2016-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-06-30","last_update":"2017-07-11","description":"Asthma is an inflammatory disease, which means it causes swelling in the lungs to cause shortness of breath and/or wheezing. There are several asthma medications that help to reduce this problem. The objective of this research study is to characterize the presence of electrophilic fatty acids in the bronchial airway of subjects with controlled asthma at baseline and after treatment with Aspirin, Indomethacin, or no treatment at all. The presence of electrophilic fatty acids may indicate inflammation. Aspirin and Indomethacin are known to respectively increase and inhibit the formation of electrophilic fatty acids. By gaining a better understanding of how electrophilic fatty acids work and how they respond to different treatment, researchers hope to be able to find better ways to lessen airway inflammation in asthma in the future.","other_id":"U10HL098177","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosis of mild to moderate asthma\r\n\r\n          -  No evidence of a previous asthma exacerbation in the preceding 6 weeks (defined as\r\n             increased severity of respiratory symptoms requiring systemic steroids or escalation\r\n             of therapy; b) asthma control questionnaire (ACQ) score less than 1.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Diagnosis of severe asthma, vocal cord dysfunction, cystic fibrosis, COPD, CAD,\r\n             hypertension, diabetes or renal failure that is not well controlled\r\n\r\n          -  Greater than 10 pack-year history of smoking;\r\n\r\n          -  Stopped smoking less than 1 year prior to study,\r\n\r\n          -  Taking any aspirin or other NSAIDS on the week prior to bronchoscopy,\r\n\r\n          -  Taking omega-3 fatty acid supplements\r\n\r\n          -  If a subject is currently taking an omega-3 fatty acid supplement and is interested in\r\n             the study, after a 30 day wash out, the participant can be re-screened and evaluated\r\n             for participation.\r\n\r\n          -  Taking pioglitazone or rosiglitazone (synthetic thiazolidinedione PPARg ligands);\r\n\r\n          -  other known pulmonary diseases;\r\n\r\n          -  Inability to undergo bronchoscopy,\r\n\r\n          -  Contraindications or allergy to aspirin or indomethacin,\r\n\r\n          -  Asthmatics with known hypersensitivity to aspirin, and\r\n\r\n          -  Steroid (systemic) dependent\r\n      ","sponsor":"Sally E. Wenzel MD","sponsor_type":"Other","conditions":"Asthma|Electrophilic Fatty Acids","interventions":[{"intervention_type":"Drug","name":"Drug: Aspirin","description":"500 mg/8 h for 5 days"},{"intervention_type":"Drug","name":"Drug: Indomethacin","description":"25 mg/8 h for 5 days"}],"outcomes":[{"outcome_type":"primary","measure":"Airway concentration of electrophilic fatty acids","time_frame":"Change in the bronchoalveolar lavage concentration of electrophilic fatty acids from the first to the second bronchoscopy","description":"Patients undergo a baseline bronchoscopy, afterwhich they are randomized to 5 days of a)indomethacin, b) aspirin, c) nothing . After treatment, another bronchoscopy is done. Outcomes are determined after each bronchoscopy"}]}
{"nct_id":"NCT02879916","start_date":"2011-10-31","phase":"Phase 4","enrollment":30,"brief_title":"Comparison of an Interscalene Nerve Block With or Without Stellate Ganglion Block for Shoulder Surgery","official_title":"Comparison of the Analgesic Effect of Levobupivacaine 0.5% Via Interscalene Nerve Block or Via Interscalene Nerve Block Combined With a Stellate Ganglion Block in Patients Undergoing Shoulder Arthroscopy With General Anaesthesia","primary_completion_date":"2013-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-09-30","last_update":"2016-10-27","description":"This study describes the difference of analgesic effect of levobupivacaine 0.5% administered through an interscalene nerve block with or without a stellate ganglion block. The length of the analgesic effect is our primary outcome parameter. Half of the recruited patients will receive a stellate ganglion block and half of the patients won't.","other_id":"11/20/162","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  ASA class 1 to 3\r\n\r\n          -  Need for shoulder surgery\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Mental retardation\r\n\r\n          -  allergy for local anesthetics\r\n\r\n          -  a medical reason as a contra-indication for NSAID use\r\n\r\n          -  Diabetes mellitus\r\n\r\n          -  peripheral neuropathy\r\n\r\n          -  chronic analgetic use\r\n\r\n          -  chronic pain patients\r\n      ","sponsor":"University Hospital, Antwerp","sponsor_type":"Other","conditions":"Anesthesia, Regional","interventions":[{"intervention_type":"Drug","name":"Drug: Levobupivacaine","description":"Inject 3ml of levobupavacaine into the stellate ganglion area"},{"intervention_type":"Drug","name":"Drug: NaCl 0.9%","description":"Inject 3ml of NaCl 0.9% into the stellate ganglion area"}],"outcomes":[{"outcome_type":"primary","measure":"Duration of analgesia","time_frame":"24 hours","description":"The duration of analgesia assessed with quantitative sensory testing"},{"outcome_type":"secondary","measure":"Need for rescue analgesia","time_frame":"24 hours","description":"The timing of the need for rescue analgesia as requested by the patient"},{"outcome_type":"secondary","measure":"Duration of motor block","time_frame":"24 hours","description":"The duration of a motor block"}]}
{"nct_id":"NCT01420705","start_date":"2011-10-31","enrollment":487,"brief_title":"Bacille Calmette-Gurin (BCG) Vaccine and Atopy","official_title":"The Effect of Giving BCG Vaccine at Birth to Low Birth-weight Infants on Development of Allergy and Asthma in Childhood - Follow up of a Randomised Trial in Guinea-Bissau","primary_completion_date":"2011-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2011-12-31","last_update":"2011-12-29","description":"The prevalence of asthma and allergic diseases is increasing worldwide. Infections and vaccinations in childhood may have an impact on the subsequent development of asthma and allergy. In Guinea-Bissau, the investigators previously found that Bacille Calmette-Gurin (BCG) vaccine was associated with reduction in atopy. Since then the investigators have conducted a randomised trial of BCG vaccine given at birth to low birth-weight infants. The present study aims to follow up children enrolled in the BCG randomised trial to assess for asthma and allergy later in childhood. Based on previous observations, the investigators expect children allocated to receive BCG at birth will have a reduction in allergy profile when compared to children who did not receive BCG at birth.","other_id":"2011-BHP-LBW-BCG-atopy","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Probability Sample","gender":"All","minimum_age":3,"maximum_age":9,"population":"Children previously enrolled in NCT00146302 living within Bandim Health Project study area,\r\n        Bissau","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Previous enrolment in NCT00146302\r\n\r\n          -  Living within Bandim Health Project study area\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Children with known history of anaphylaxis\r\n\r\n          -  Children with skin infections or severe skin conditions for who SPT could not be\r\n             reliably performed\r\n\r\n          -  Children currently taking anti-histamine medication\r\n      ","sponsor":"Bandim Health Project","sponsor_type":"Other","conditions":"Asthma|Eczema|Food Hypersensitivity","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Skin prick test","time_frame":"Single observation at time of consent - DAY 1","description":"Skin prick tests to common aero and food allergen"},{"outcome_type":"secondary","measure":"Symptoms of asthma","time_frame":"Single observation at time of consent - DAY 1","description":"Symptoms of asthma using questions modified from ISAAC"},{"outcome_type":"secondary","measure":"Symptoms of eczema","time_frame":"Single observation at time of consent - DAY 1","description":"Eczema symptoms using questions modified from ISAAC"},{"outcome_type":"secondary","measure":"Symptoms of food allergy","time_frame":"Single observation at time of consent - DAY 1","description":"Symptoms of food allergy using questions modified from the Health Nuts study"}]}
{"nct_id":"NCT01448863","start_date":"2011-10-31","enrollment":28,"brief_title":"Metabolomic Embryo Profiles of Obese in Vitro Fertilization (IVF) Patients and Their Relationship With Polycystic Ovary Syndrome (PCO)","primary_completion_date":"2014-10-31","study_type":"Observational","rec_status":"Completed","completion_date":"2014-10-31","last_update":"2015-03-10","description":"The present study aims to elucidate if there is a metabolomic profile alteration in the embryos of obese women in order to understand if the reduced implantation rate observed in these patients is directly related to this factor. Furthermore, the investigators seek to establish if there is any difference between obese women with Polycystic Ovary Syndrome (PCO) and without PCO. The investigators compare these metabolomic profile embryos with embryos of egg-donation programme.","other_id":"1005-C-070-JB","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":38,"population":"45 women divided into three groups: A)15 Obese women without Polycystic Ovarian Syndrome:\r\n        BMI > 30 kg/m2 , age < 38 years old, normal basal hormonal profile (FSH, LH, estradiol,\r\n        testosterone, androstenedione, insulin, SHBG, glucose, AMH, and antral follicle count(> 5\r\n        FA for each ovary), menses every 25-35 days.\r\n\r\n        B)15 Obese women with Polycystic Ovarian Syndrome: BMI > 30 kg/m2, age < 38 years old,\r\n        basal hormonal profile with or without hyperandrogenism and ultrasound ovary aspect of PCO.\r\n\r\n        C)15 Fertile women (egg-donors): BMI 20-24.9 kg/m2. All the patients have normal uterine\r\n        conditions, are not smokers, without endometriosis or hidrosalpinx. All the male partners\r\n        have sperm parameters: count(> 5 mill/ml,15% motility,> 0% normal morphology)and BMI < 28\r\n        kg/m2.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  BMI > 30 kg/m2\r\n\r\n          -  Age < 38 years old\r\n\r\n          -  Non smokers\r\n\r\n          -  First IVF cycle (groups 2 & 3, not Control group)\r\n\r\n          -  Normal uterus (seen by ultrasound)\r\n\r\n          -  normal basal hormonal profile(FSH,LH,estradiol,testosterone,androstenedione, insulin,\r\n             SHBG, glucose, AMH)\r\n\r\n          -  Antral follicle count(> 5 FA for each ovary)\r\n\r\n          -  Menses every 25-35 days.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  < 5 or > 20 oocytes retrieved after stimulation cycle\r\n\r\n          -  estradiol >3000 pg/ml or progesterone > 1,5 ng/ml on the hCG day.\r\n\r\n          -  < 2 evolutive embryos in the culture medium.\r\n      ","sponsor":"Instituto Valenciano de Infertilidad, IVI VALENCIA","sponsor_type":"Other","conditions":"Infertility|Obesity","interventions":[{"intervention_type":"Other","name":"Other: Culture medium metabolomic analysis","description":"During the embryo transfer at day 3, the investigators keep and freeze a small drop of the culture medium of each embryo transferred. Each drop of culture medium will have a volume of 40-50 microliters, before freezing is spun at 10.000 rps to avoid any possible contamination.\r\nThe frozen media culture is analyzed for the metabolomic profile."}],"outcomes":[{"outcome_type":"primary","measure":"Metabolic profile of culture media of Day 3 embryos","time_frame":"3 days","description":"Determine differences in the metabolomic profile of the culture media of day 3 embryos, obtained after in vitro fertilization, according to the presence of obesity associated or not with polycystic ovary syndrome."}]}
{"nct_id":"NCT01465035","start_date":"2011-10-31","phase":"Phase 1","enrollment":24,"brief_title":"A Study to Determine the Safety and Immunogenicity of Co-administration of the Candidate Influenza Vaccine MVA-NP+M1 and Seasonal Influenza Vaccine","official_title":"A Phase I Study to Determine the Safety and Immunogenicity of Co-administration of the Candidate Influenza Vaccine MVA-NP+M1 and Seasonal Influenza Vaccine","primary_completion_date":"2012-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-11-30","last_update":"2012-11-29","description":"This is a single blinded placebo controlled phase I study, to assess the safety and immunogenicity of co-administration of the candidate influenza vaccine MVA-NP+M1 with seasonal influenza vaccine. All volunteers recruited will be adults aged 50 and over. The rationale behind co-administration of MVA-NP+M1 with a seasonal influenza vaccine (TIV) is that the immune system will be stimulated to produce both influenza specific T cells and influenza specific antibodies.","other_id":"Flu003","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Men and women aged 50 or over with no upper age limit\r\n\r\n          -  Resident in or near Oxford for the duration of the vaccination study\r\n\r\n          -  Able and willing (in the Investigators' opinions) to comply with all study\r\n             requirements\r\n\r\n          -  Willing to allow the investigators to discuss the volunteer's medical history with\r\n             their General Practitioner\r\n\r\n          -  For females who are not post-menopausal, a negative pregnancy test on the day of\r\n             vaccination and agreement to practice effective contraception for the duration of the\r\n             study\r\n\r\n          -  Agreement to refrain from blood donation during the course of the study\r\n\r\n          -  Written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n        Participation in another research study involving an investigational product in the 30 days\r\n        preceding enrolment, or planned use during the study period\r\n\r\n          -  Receipt of MVA or smallpox vaccines in the last 5 years, or receipt of the 2011/12\r\n             seasonal influenza vaccine prior to entering the study.\r\n\r\n          -  Administration of immunoglobulins and/or any blood products within the three months\r\n             preceding the planned administration of the vaccine candidate\r\n\r\n          -  Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV\r\n             infection; asplenia; recurrent, severe infections and chronic (more than 14 days)\r\n             immunosuppressant medication within the past 6 months (inhaled/topical steroids are\r\n             allowed)\r\n\r\n          -  History of allergic disease or reactions likely to be exacerbated by any component of\r\n             the vaccine, e.g. egg products\r\n\r\n          -  Any history of anaphylaxis in reaction to vaccination\r\n\r\n          -  Recent treatment for cancer (except basal cell carcinoma and cervical carcinoma in\r\n             situ)\r\n\r\n          -  History of serious psychiatric condition\r\n\r\n          -  Suspected or known current injecting drug or alcohol abuse (as defined by an alcohol\r\n             intake of greater than 42 units every week)\r\n\r\n          -  Seropositive for hepatitis B surface (HBsAg) or hepatitis C virus (antibodies to HCV)\r\n\r\n          -  For pre-menopausal females, pregnancy, lactation or willingness/intention to become\r\n             pregnant during the study\r\n\r\n          -  Any other significant disease, disorder or finding (including blood test results),\r\n             which, in the opinion of the Investigators, would either put the volunteer at risk\r\n             because of participation in the study, or may influence the result of the study.\r\n\r\n          -  No response / confirmation from GP regarding previous medical history\r\n      ","sponsor":"University of Oxford","sponsor_type":"Other","conditions":"Influenza","interventions":[{"intervention_type":"Biological","name":"Biological: TIV and MVA-NP+M1","description":"1.5 x 108 pfu MVA-NP+M1, intramuscular injection into the thigh. Inactivated Influenza Vaccine (Split Virion) 0.5ml (containing 15 micrograms of haemagglutinin, intramuscular injection into the thigh"},{"intervention_type":"Biological","name":"Biological: Saline placebo and seasonal influenza vaccine TIV","description":"Saline placebo, intramuscular injection into the thigh. Inactivated Influenza Vaccine (Split Virion) 0.5ml (containing 15 micrograms of haemagglutinin, intramuscular injection into the thigh"}],"outcomes":[{"outcome_type":"primary","measure":"Safety of co-administration of MVA-NP+M1 and seasonal influenza vaccine.","time_frame":"Participants will be followed for the duration of the study, an expected average of 6 months","description":"The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events."},{"outcome_type":"secondary","measure":"Immune response generated by co-administration of MVA-NP+M1 and seasonal influenza vaccine","time_frame":"Participants will be followed for the duration of the study, an expected average of 6 months","description":"To assess immune response generated by co-administration of MVA-NP+M1 by interferon-gamma ELISpot and ELISA."}]}
{"nct_id":"NCT01604993","start_date":"2011-10-31","phase":"Phase 2","enrollment":31,"brief_title":"Acute Effect of Nitrate From Natural Dietary Sources on Arterial Stiffness and Blood Pressures in Healthy Individuals","official_title":"Acute Effect of Nitrate Supplementation From Natural Dietary Sources on Arterial Stiffness and Aortic and Brachial Blood Pressures: a Double-blind, Placebo-controlled, Randomized, Crossover Clinical Trial in Healthy Adults","primary_completion_date":"2012-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-10-31","last_update":"2014-03-10","description":"The purpose of this study is to evaluate the acute effect of a meal high in dietary nitrates on aortic augmentation index, brachial and aortic blood pressures, and subendocardial viability ration (SEVR).","other_id":"11216","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Health Services Research","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy volunteers aged 18-50\r\n\r\n          -  Must consider themselves to be in good overall health and be free of any conditions or\r\n             illnesses Women must be post-menopausal or not pregnant.\r\n\r\n          -  Body mass index (BMI) must be <30kg/m^2.\r\n\r\n          -  Normotensive, as defined by brachial SBP <140mmHg and DBP <90mmHg\r\n\r\n          -  Subjects must also be willing to stop using mouthwash for the duration of their\r\n             participation in the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Women of childbearing age may not be pregnant, planning to become pregnant, or\r\n             breastfeeding at the time of the study\r\n\r\n          -  BMI >30kg/m^2\r\n\r\n          -  Hypertensive as defined by brachial SBP >140mmHg and/or DBP >90mmHg\r\n\r\n          -  Allergy or sensitivity to the study product, reference therapy or nitrates\r\n\r\n          -  Having any gastrointestinal complication or condition\r\n\r\n          -  Chronic use of medications such as prescription NSAIDs, antacids, blood-thinners,\r\n             hypertensive medications, medications affecting NO synthesis such as Viagra, and use\r\n             of antibiotics within one month of the study start\r\n\r\n          -  Individuals who are involved in another clinical trial.\r\n      ","sponsor":"Unity Health Toronto","sponsor_type":"Other","conditions":"Healthy","interventions":[{"intervention_type":"Other","name":"Other: Spinach soup","description":"556 g of high Nitrate spinach soup that is orally consumed as a single dose for 7 days"},{"intervention_type":"Other","name":"Other: Asparagus soup","description":"556 grams of low nitrate asparagus soup that is orally consumed for a period of 7 days as a single does"}],"outcomes":[{"outcome_type":"primary","measure":"Aortic augmentation index (arterial stiffness)","time_frame":"At each treatment visits, this measurement will be taken in at baseline, 1, 2, and 3 hours post-treatment."},{"outcome_type":"secondary","measure":"Peripheral (brachial) and central (aortic) systolic and diastolic blood pressure","time_frame":"Brachial blood pressure will be measured at 0 , 1, 2, and 3 hours post -treatmentbaseline and at 1, 2 and 3 hours at every visit."},{"outcome_type":"secondary","measure":"Subendocardial viability ratio (SEVR)","time_frame":"At 1 hours intervals starting from baseline and ending at 3 hours."}]}
{"nct_id":"NCT01358422","start_date":"2011-10-31","enrollment":830,"brief_title":"Occurrence of Bleeding and Thrombosis During Antiplatelet Therapy in Non-cardiac Surgery","official_title":"Occurrence of Bleeding and Thrombosis During Antiplatelet Therapy in Non-cardiac Surgery. A Prospective Observational Study (OBTAIN Study)","primary_completion_date":"2013-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2014-01-31","last_update":"2015-10-14","description":"Research questions: 1. What is the absolute risk reduction for in-hospital major adverse cardiac events (MACE) associated with the use of dual anti-platelet therapy as compared with aspirin alone in this population? 2. What is the absolute risk increase for clinically significant bleeding during the same period associated with the use of dual anti-platelet therapy as compared with aspirin alone in this population? In brief the design of the study is as follows: - We will study patients undergoing non-cardiac surgery within four years of coronary stenting. - We will record the anti-platelet agents taken by patients before, during and after surgery. - We will record cardiac and bleeding events that occur whilst the patient is in hospital. - We will use the statistical technique of propensity scoring to match patients who have similar risk factors and who received different anti-platelet regimens. - We will compare the incidence of cardiac events and bleeding in the matched groups.","other_id":"OBTAIN","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"Patients undergoing non-cardiac surgery within four years of percutaneous coronary\r\n        intervention (PCI) with the placement of a bare metal or drug eluting stent will be\r\n        included in the study.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients undergoing non-cardiac surgery within four years of percutaneous coronary\r\n             intervention (PCI) with the placement of a bare metal or drug eluting stent will be\r\n             included in the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients maintained on anticoagulant therapy e.g. heparin infusion before and after\r\n             surgery will be excluded. (Patients receiving prophylactic doses of heparin for\r\n             prevention of thromboembolic events will be eligible for inclusion.)\r\n\r\n          -  Patients receiving bridging therapy with full anticoagulant does of heparin or other\r\n             drugs to compensate for the withdrawal of antiplatelet drugs will be excluded.\r\n\r\n          -  Patients who are anticoagulated with warfarin (INR>1.5 at the time of surgery) will be\r\n             excluded.\r\n\r\n          -  Patients receiving full anticoagulation with heparin for a known recent a known\r\n             thromboembolic event (APPT ratio > 1.5) be excluded. -\r\n      ","sponsor":"European Society of Anaesthesiology","sponsor_type":"Other","conditions":"Bleeding|Thrombosis|Cardiac Events","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"1. MACE","time_frame":"In-hospital stay up to 30 days","description":"This study will record and analyse in-hospital adverse cardiac events. Major Adverse Cardiac Events (MACE) will be defined as a composite of:\r\nMyocardial infarction as defined by the Universal Definition of Myocardial Infarction(including cardiac arrest and cardiac death as described in this definition).\r\nPCI for a cardiac event occurring following surgery."},{"outcome_type":"primary","measure":"2. Clinically significant bleeding","time_frame":"In-hospital stay up to 30 days","description":"This study will record and analyse in-hospital clinically significant bleeding.\r\nClinically Significant Bleeding Events will be defined as:\r\nReoperation for bleeding.\r\nGastrointestinal haemorrhage\r\nIntracranial haemorrhage\r\nSpinal/epidural haematoma. The transfusion of blood and blood products will also be recorded and compared between patients on dual antiplatelet therapy and aspirin alone."}]}
{"nct_id":"NCT01245608","start_date":"2011-10-31","phase":"Phase 3","enrollment":2400,"brief_title":"Prevention of Cardiovascular Disease Using a Single PolyPill in an Urban Population - Focus on Liver-Related Variables.","official_title":"Fixed-dose Combination Therapy (PolyPill) in Prevention of Cardiovascular Disease in Middle-aged and Elderly Iranians - Focus on Liver-Related Variables.","primary_completion_date":"2018-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-09-30","last_update":"2019-02-15","description":"The primary purpose of this study is to determine the effects of a fixed dose combination of valsartan, hydrochlorothiazide, atorvastatin and aspirin (PolyPill) on prevention of cardiovascular events in adults older than 50. Various liver-related variables will also be recorded which will allow studying the effects of PolyPill on the liver and the effect of liver diseases such as nonalcoholic steatohepatitis on cardiovascular events and the protective effect of PolyPill.","other_id":"90-03-37-15582","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        - Being enrolled in Golestan Cohort Study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Debilitating disease causing inability to comply\r\n\r\n          -  Contraindications to any of the components of PolyPill\r\n\r\n          -  Not consenting to the study\r\n      ","sponsor":"Tehran University of Medical Sciences","sponsor_type":"Other","conditions":"Cardiovascular Diseases","interventions":[{"intervention_type":"Drug","name":"Drug: Polypill","description":"Polypill taken once daily for 5 years. Each pill contains acetylsalicylic acid 81 mg, atorvastatin 20 mg, hydrochlorothiazide 12.5 mg, valsartan 40 mg"}],"outcomes":[{"outcome_type":"primary","measure":"Major Cardiovascular Events","time_frame":"5 years","description":"The first occurrence of hospitalization for acute coronary syndrome (non-fatal myocardial infarction and unstable angina), fatal myocardial infarction, sudden death, new-onset heart failure, coronary artery revascularization procedures and stroke (fatal or non-fatal)."},{"outcome_type":"secondary","measure":"Side effects","time_frame":"5 years","description":"questionnaire"},{"outcome_type":"secondary","measure":"Changes in liver enzyme levels","time_frame":"5 years","description":"AST, ALT"},{"outcome_type":"secondary","measure":"Changes in liver stiffness","time_frame":"5 years","description":"As measured by fibroscan"},{"outcome_type":"secondary","measure":"Compliance","time_frame":"5 years","description":"Pill count"},{"outcome_type":"secondary","measure":"Fat deposition","time_frame":"5 years","description":"Visceral Adipose Tissue thickness (VAT), Subcutaneous Adipose Tissue thickness (SAT) and carotid intima-media thickness (IMT)"},{"outcome_type":"secondary","measure":"All-cause Mortality","time_frame":"5 years","description":"Yearly follow-up"}]}
{"nct_id":"NCT01792765","start_date":"2011-10-31","phase":"N/A","enrollment":50,"brief_title":"Management of Ureteral Calculi Using Ultrasound Guidance: A Radiation Free Approach","official_title":"Management of Ureteral Calculi Using Ultrasound Guidance: A Radiation Free Approach","primary_completion_date":"2013-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-10-31","last_update":"2015-02-10","description":"Kidney stones are very common, and can inflict a significant degree of pain and renal damage. Some stones become obstructed in the ureter, the tube that drains the kidney. In order to remove these stones, an Urologist and their team use fluoroscopic guidance to do so, this involves continuous X-ray. Flouroscopy delivers a significant dose of radiation to the patient, as well as the health care team, which has been shown to have serious health consequences. Previous studies have shown that in certain populations, like pregnant women, stones can be managed using ultrasound guidance. The investigators propose that mid and distal ureteral stones could be managed using ultrasound guidance in conjunction with conventional stone removal techniques (ureteroscopy, lithotripsy, and ureteral stent placement), in lieu of fluoroscopy, thereby minimizing radiation to healthcare staff and patients. The investigators hypothesize that distal ureteral stones can be identified and efficiently fragmented and removed under ultrasound guidance in a safe and effective manner without the use of radiation.","other_id":"22487 (CPHS)","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Selection criteria will include adult patients with mid and distal ureteral stones 8mm,\r\n        and will be stented prior to presenting for their intervention. Ureteral stenting prior to\r\n        ureteroscopy is the standard at Dartmouth Hitchcock Medical Center, and both the test and\r\n        control group will be stented for two weeks prior to their procedure. Initial ureteral\r\n        stenting will be performed using conventional fluoroscopy at the discretion of the surgeon\r\n        as this may be in the acute setting and not within the scope of this trial. The mid and\r\n        distal portion of the ureter refers to the segment of ureter that extends from the upper\r\n        portion of the sacrum distally to the bladder.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Patients will be excluded from the trial if they have had surgical resection involving the\r\n        bladder or ureter, or a history of known ureteral stricture. Also, this is only for adult\r\n        patients (>18yo).\r\n      ","sponsor":"Dartmouth-Hitchcock Medical Center","sponsor_type":"Other","conditions":"Urolithiasis","interventions":[{"intervention_type":"Other","name":"Other: Ultrasound guidance","description":"Patient will have intraoperative ultrasound ."}],"outcomes":[{"outcome_type":"primary","measure":"Safety of ultrasound guided ureteroscopy","time_frame":"Day1","description":"We assess to see if patients had any intraoperative complications during this study, or have any post operative complications as a result of their treatment."},{"outcome_type":"secondary","measure":"To assess the efficacy of ultrasound guided ureteroscopy for management of distal ureteral stones.","time_frame":"post operatively at 4-6wks post op","description":"We determine if we can render patients stone free using this novel method. We also determine if this is a viable option to introduce into the OR in terms of use of operative time, which is the most expensive variable when looking at this individual urologic procedure."}]}
{"nct_id":"NCT01428622","start_date":"2011-10-31","phase":"Phase 2","enrollment":0,"brief_title":"Olodaterol Bridging Study in Asthma","official_title":"Single Dose Comparison of 3 Doses of Olodaterol in Double Fixed Dose Combination With BI54903 vs. 3 Doses of Olodaterol Mono in Free Combination","study_type":"Interventional","rec_status":"Withdrawn","last_update":"2011-11-22","description":"The aim of the study is to establish the olodaterol dose in the ethanolic fixed dose combination (FDC) with BI 54903 which is equivalent in bronchodilator effect and systemic exposure to the 5 g olodaterol reference dose in the aqueous inhalation solution (AIS).","other_id":"1249.7","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion criteria:\r\n\r\n          1. Informed Consent Form consistent guidelines and local legislation prior\r\n\r\n          2. Male or female patients aged at least 18 to 75 years.\r\n\r\n          3. Diagnosis of asthma according to the 2009 Global Initiative for Asthma (GINA)\r\n             Guidelines.\r\n\r\n          4. Maintenance treatment with a low or medium dose of inhaled corticosteroids (ICS) with\r\n             or without Long-acting beta-adrenergic (LABA), stable dose of inhaled corticosteroids\r\n             (alone or in a fixed combination with a LABA) for at least for 6 weeks prior to\r\n             screening.\r\n\r\n          5. Asthma control questionaire (ACQ)-6 mean score of < 1.5.\r\n\r\n          6. a. Pre-bronchodilator clinic measured FEV1 =50% and =90% of predicted normal b. FEV1\r\n             reversibility: Improvement in FEV1 =12% above baseline and an absolute change of at\r\n             least 200 ml within 15-30 minutes after administration of 400 g salbutamol.\r\n\r\n          7. Never-smokers or ex-smokers with a smoking history of less than 10 pack-years and\r\n             smoking cessation at least one year prior to screening.\r\n\r\n          8. Be able to use the inhalers correctly in the opinion of the investigator.\r\n\r\n          9. Be able to perform all trial related procedures.\r\n\r\n        Exclusion criteria:\r\n\r\n          1. Significant disease other than asthma.\r\n\r\n          2. Recent history (i.e. six months or less) of myocardial infarction.\r\n\r\n          3. Hospitalisation for cardiac failure during the past year.\r\n\r\n          4. Unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring\r\n             intervention or a change in drug therapy within the past year.\r\n\r\n          5. Lung diseases other than asthma (e.g. Chronic obstructive pulmonary disease).\r\n\r\n          6. Active tuberculosis.\r\n\r\n          7. Malignancy for which the patient has undergone resection, radiation therapy or\r\n             chemotherapy within the last five years.\r\n\r\n          8. Thoracotomy with pulmonary resection.\r\n\r\n          9. Alcohol or drug abuse within the past two years.\r\n\r\n         10. Pulmonary rehabilitation program\r\n\r\n         11. Hypersensitivity to LABA drugs, ciclesonide, salmeterol or any other components of the\r\n             study medication delivery systems.\r\n\r\n         12. Pregnant or nursing woman.\r\n\r\n         13. Women of childbearing potential not using a highly effective method of birth control.\r\n      ","sponsor":"Boehringer Ingelheim","sponsor_type":"Industry","conditions":"Asthma","interventions":[{"intervention_type":"Drug","name":"Drug: BI54903","description":"ethanolic solution"},{"intervention_type":"Drug","name":"Drug: BI54903","description":"ethanolic solution"},{"intervention_type":"Drug","name":"Drug: BI54903","description":"ethanolic solution"},{"intervention_type":"Drug","name":"Drug: BI54903","description":"ethanolic solution"},{"intervention_type":"Drug","name":"Drug: BI54903","description":"ethanolic solution"},{"intervention_type":"Drug","name":"Drug: BI54903","description":"ethanolic solution"},{"intervention_type":"Drug","name":"Drug: BI54903","description":"ethanolic solution"},{"intervention_type":"Device","name":"Device: Respimat","description":"aqueous and ethanolic solution"},{"intervention_type":"Device","name":"Device: Respimat","description":"aqueous and ethanolic solution"},{"intervention_type":"Device","name":"Device: Respimat","description":"aqueous and ethanolic solution"},{"intervention_type":"Device","name":"Device: Respimat","description":"aqueous and ethanolic solution"},{"intervention_type":"Device","name":"Device: Respimat","description":"aqueous and ethanolic solution"},{"intervention_type":"Device","name":"Device: Respimat","description":"aqueous and ethanolic solution"},{"intervention_type":"Device","name":"Device: Respimat","description":"aqueous and ethanolic solution"},{"intervention_type":"Drug","name":"Drug: Olodaterol","description":"aqueous solution"},{"intervention_type":"Drug","name":"Drug: Olodaterol","description":"aqueous solution"},{"intervention_type":"Drug","name":"Drug: Olodaterol","description":"aqueous solution"},{"intervention_type":"Drug","name":"Drug: Olodaterol","description":"aqueous solution"},{"intervention_type":"Drug","name":"Drug: Olodaterol","description":"aqueous solution"},{"intervention_type":"Drug","name":"Drug: Olodaterol","description":"aqueous solution"},{"intervention_type":"Drug","name":"Drug: Olodaterol","description":"aqueous solution"},{"intervention_type":"Drug","name":"Drug: Olodaterol & BI54903","description":"ethanolic solution"},{"intervention_type":"Drug","name":"Drug: Olodaterol & BI54903","description":"ethanolic solution"},{"intervention_type":"Drug","name":"Drug: Olodaterol & BI54903","description":"ethanolic solution"},{"intervention_type":"Drug","name":"Drug: Olodaterol & BI54903","description":"ethanolic solution"},{"intervention_type":"Drug","name":"Drug: Olodaterol & BI54903","description":"ethanolic solution"},{"intervention_type":"Drug","name":"Drug: Olodaterol & BI54903","description":"ethanolic solution"},{"intervention_type":"Drug","name":"Drug: Olodaterol & BI54903","description":"ethanolic solution"}],"outcomes":[{"outcome_type":"primary","measure":"FEV1 (AUC0-12h) FEV1 = Forced expiratory volume in one second, AUC = area under the curve","time_frame":"12 hours"},{"outcome_type":"secondary","measure":"FEV1 (AUC0-24h)","time_frame":"24 hours"},{"outcome_type":"secondary","measure":"FEV1 (AUC12-24h)","time_frame":"12 hours"},{"outcome_type":"secondary","measure":"Peak FEV1","time_frame":"12 hours"}]}
{"nct_id":"NCT01421771","start_date":"2011-10-31","phase":"N/A","enrollment":126,"brief_title":"Blood Pressure in Dialysis Patients","official_title":"Blood Pressure in Dialysis Patients (BID Study)","primary_completion_date":"2016-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-06-30","last_update":"2017-01-06","description":"Hypertension is a major cause of cardiovascular (CV) morbidity and mortality. Although studies in the general population have demonstrated a continuous reduction in CV risk with each mmHg drop in systolic blood pressure (SBP), multiple observational studies conducted in hemodialysis (HD) patients have demonstrated that patients with mild to moderate hypertension may have decreased mortality compared to those with normal blood pressure (BP). The investigators recently reported that among HD patients, those with routine pre-dialysis BP values that met the Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines (<140/90 mm Hg) had increased mortality compared to patients with mild to moderate hypertension. However, these observational studies included untreated patients in whom low or normal BP may reflect significant cardiac disease or other comorbid conditions. In the setting of reduced vascular compliance and impaired autoregulation, aggressive BP lowering may decrease coronary or cerebral perfusion. Thus, it is unclear if aggressive BP lowering will be harmful or beneficial. A well-designed randomized control trial (RCT) is needed to answer this important question. Prior to conducting a full-scale RCT it is prudent to conduct a pilot study to assess feasibility and inform the design of the former. The investigators propose to conduct a pilot RCT in a prevalent cohort of HD patients to assess the safety and feasibility of treating patients to a low (110-140 mmHg)and standard (155-165) mm Hg pre-dialysis BP target.","other_id":"1R01DK083424-01A1","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria\r\n\r\n          1. Age  18 years\r\n\r\n          2. On thrice weekly maintenance hemodialysis for greater than 90 days\r\n\r\n          3. For entry into baseline period: 2-week average RDUSBPM > 155 mm Hg on AHT medications\r\n             or < 155 mm Hg on  1 AHT medications For randomization: 2-week average SDUSBPM  155\r\n             mm Hg\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Two- week average, pre-dialysis mid-week SDUSBPM 180 mmHg on maximal doses of  4\r\n             antihypertensive agents;\r\n\r\n          2. Inability to measure blood pressures in an upper arm;\r\n\r\n          3. History of inter or post-dialytic hypotension (defined as systolic blood pressure <90\r\n             mmHg) within the past 2 weeks or inter- or post- dialytic hypotension requiring\r\n             hospitalization (including emergency room visit) and/or the use of midodrine in the\r\n             past 6 months;\r\n\r\n          4. Required one or more urgent, unscheduled dialysis treatment for congestive heart\r\n             failure in the past 3 months (other than in an incident patient at the time of\r\n             starting dialysis);\r\n\r\n          5. Acute myocardial infarction, unstable angina or stroke/ TIA in past three the 3\r\n             months;\r\n\r\n          6. Severe aortic valve stenosis (valve area <1cm 2) carotid artery stenosis (>70%\r\n             stenosis);\r\n\r\n          7. Known abdominal aortic aneurysm >5 cm in diameter or thoracic aortic aneurysm of any\r\n             diameter;\r\n\r\n          8. Body mass index >40 kg/m2 or arm circumference > 52 cm, which precludes measuring\r\n             blood pressure with the \"thigh\" blood pressure cuff;\r\n\r\n          9. Life expectancy <1 year;\r\n\r\n         10. A living donor, kidney transplant, or switch to peritoneal dialysis scheduled within\r\n             the next year;\r\n\r\n         11. Significant cognitive impairment;\r\n\r\n         12. spKt/V 1.2 in the past 2 months;\r\n\r\n         13. Active liver disease;\r\n\r\n         14. Active alcohol or substance abuse including narcotics within the past year;\r\n\r\n         15. Contraindication to cardiac MRI;\r\n\r\n         16. Current or planned pregnancy within the next year;\r\n\r\n         17. Unwillingness to consent to pregnancy test and/or use of birth control if of\r\n             childbearing potential;\r\n\r\n         18. Suspicion that the participant will not be willing or able to adhere to prescribed\r\n             medications and study protocol;\r\n\r\n         19. Incarcerated;\r\n\r\n         20. Significant concern about the study expressed by spouse, significant other, family\r\n             member primary nephrologist or primary care physician;\r\n\r\n         21. Participation in another intervention study;\r\n\r\n         22. Unable to speak or understand English or Spanish;\r\n\r\n         23. Plan to relocate within one year;\r\n\r\n         24. participation in another intervention study .\r\n      ","sponsor":"University of New Mexico","sponsor_type":"Other","conditions":"Hypertension|Renal Failure Chronic Requiring Hemodialysis|Blood Pressure|Dialysis","interventions":[{"intervention_type":"Drug","name":"Drug: Antihypertensive Agents","description":"Study formulary consists of ACE/ARB, Beta Adrenergic Blocker, Calcium Channel Blocker, vasodilators, peripheral alpha antagonist and central alpha agonist.\r\nACE I or ARB is first line, the order of addition of subsequent medications is per the discretion of the investigator"},{"intervention_type":"Other","name":"Other: Dry weight Challenge","description":"Reduce the estimated dry weight of the patient's progressively over 2 -week intervals until the dry weight challenge is no longer tolerated or the patient is at BP goal"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Extend dialysis treatment time and re-challenge estimated dry weight","description":"Extend dialysis treatment time and re-challenge estimated dry weight"}],"outcomes":[{"outcome_type":"primary","measure":"Feasibility and safety of randomizing patients to an intensive (110-140 mm Hg) and standard (155-165mm Hg)pre-dialysis standardized BP Goal","time_frame":"one year","description":"To assess the safety and feasibility of randomizing patients to each of the BP arms To assess rates of intradialytic hypotension requiring intervention, SAEs, hospitalizations, CV-related hospitalizations between treatment arms"},{"outcome_type":"secondary","measure":"Change in LV mass","time_frame":"One year","description":"LV mass will be measured by MRI at baseline and one year after randomization"},{"outcome_type":"secondary","measure":"Adverse events, serious adverse events, major CVD events and mortality","time_frame":"One year","description":"Adverse events, serious adverse events, major CVD events and mortality will be evaluated over one year across study arms"},{"outcome_type":"secondary","measure":"Health-related quality of life","time_frame":"One year","description":"HRQOL will be assessed using the SF-36, and the Fact fatigue scale and a validated question about dialysis recovery time at baseline and one year after randomization"}]}
{"nct_id":"NCT02022267","start_date":"2011-10-31","enrollment":51,"brief_title":"Gait Analysis in Ponseti Clubfoot","official_title":"Results of Gait Analysis Including Oxford Foot Model in Children With Clubfoot Treated With the Ponseti Method","primary_completion_date":"2012-02-29","study_type":"Observational","rec_status":"Completed","completion_date":"2012-09-30","last_update":"2013-12-27","description":"Patients with clubfoot treated with the Ponseti method from a prospective database are evaluated using gait analysis including a foot model and a disease specific instrument score and compared to a group of healthy children.","other_id":"EK10-218-1210","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":3,"maximum_age":12,"population":"Patients with a minimum age of three years from a prospective, consecutive database of\r\n        patients with clubfoot treated with the Ponseti method beginning in 2002","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  unilateral or bilateral idiopathic clubfoot treated with the Ponseti method\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  clubfoot associated with syndromes or neurological diseases\r\n\r\n          -  mild clubfoot that required fewer than three casts for initial correction\r\n\r\n          -  clubfoot patients that first presented at an age older than three months\r\n\r\n          -  clubfoot patients who were living outside of the Country\r\n\r\n          -  clubfoot patients who were treated elsewhere with more than three casts\r\n      ","sponsor":"Orthopedic Hospital Vienna Speising","sponsor_type":"Other","conditions":"Clubfoot","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"3D Gait Analysis with foot model","time_frame":"once at time of presentation for study specific examination; invitations were sent out end of 2011, a second letter three months after the first. After second letter patients had a time frame of three more months to participate before study was closed","description":"Gait analysis, including video recordings with a Vicon motion capture system (Vicon, Oxford, UK) with kinetic data collected from three AMTI force plates (Advanced Mechanical Technology, Inc., Watertown, MA). Placement of markers will be a combination of Cleveland (lower extremity), PlugInGait (upper body), and Oxford Foot (movement within the foot) models."},{"outcome_type":"secondary","measure":"Clinical examination","time_frame":"once at time of presentation for study specific examination; invitations were sent out end of 2011, a second letter three months after the first. After second letter patients had a time frame of three more months to participate before study was closed","description":"Active and passive range of motion (ROM) of the ankle joint measured with a hand-held goniometer. Ability to walk on the heels and on tiptoes."},{"outcome_type":"secondary","measure":"disease-specific instrument questionnaire","time_frame":"once at time of presentation for study specific examination; invitations were sent out end of 2011, a second letter three months after the first. After second letter patients had a time frame of three more months to participate before study was closed","description":"questionnaire as described in citation"}]}
{"nct_id":"NCT01519362","start_date":"2011-10-31","enrollment":1,"brief_title":"A Woman Suffered From Leukocytopenia and Widespread Migration After Polyacrylamide Hydrogel (PAAG) Injection in Epicranial Aponeurosis","study_type":"Observational","rec_status":"Completed","last_update":"2012-01-26","description":"Polyacrylamide hydrogel (PAAG) has been used as an injectable filler for soft tissue augmentation in different parts of the body , such as face, breast , or even penis for more than a decade . However, there are never reports about the application of a large amount of PAAG in epicranial aponeurosis to change the contour of the upper cranium accompanied with leukocytopenia. This fancy application turned out to be a disaster for the women who suffered from leukocytopenia , widespread migration of PAAG, recurrent swelling of the affected tissues and temporal pain changing with the temperature and the facial expression .","other_id":"zhangduo","observational_model":"Case-Only","time_perspective":"Retrospective","sampling_method":"Probability Sample","gender":"Female","minimum_age":50,"maximum_age":50,"population":"A 50-year-old lady had PAAG injected into her bilateral temporal epicranial aponeurosis for\r\n        augmentation","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  PAAG injected into bilateral temporal epicranial aponeurosis\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  PAAG injected into other parts of the body\r\n      ","sponsor":"Duo Zhang","sponsor_type":"Other","conditions":"Complication","interventions":{},"outcomes":{}}
{"nct_id":"NCT01433718","start_date":"2011-09-30","phase":"N/A","enrollment":0,"brief_title":"Decreasing Knee Injury Risk Factors With Neuromuscular Training","official_title":"The Effectiveness of Neuromuscular Training on Modifiable Anterior Cruciate Ligament Injury Risk Factors","primary_completion_date":"2012-02-29","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2012-06-30","last_update":"2017-04-21","description":"Anterior cruciate ligament (ACL) tears are disabling injuries that place a significant burden on the athlete. Roughly 80% of these injuries are linked to a noncontact mechanism, with more than 70% of them occurring while landing from a jump. Female athletes are at higher risk of sustaining a noncontact ACL injury due to the higher number of risk factors that they possess compared to their male counterparts. Due to this statistic, ACL prevention programs have been developed over the past 15 years in attempt to reduce this risk among the female athletic population. These programs have been shown to reduce the rate of noncontact ACL injuries in females by correcting the risk factors associated with them. However, it remains unclear as to whether these positive results are solely due to the program or a higher exercise workload in its participants. The purpose of this study is to evaluate the effectiveness that an ACL prevention program has on modifying at-risk landing mechanics (associated with noncontact ACL injury) compared to a resistance training program of equal workload.","other_id":"Ohio_U11F024","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":20,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Female college underclassman (ages 18-20)\r\n\r\n          -  Body Mass Index (BM) between 18.5 - 25 (normal range)\r\n\r\n          -  Blood pressure below 140/90 (below hypertension)\r\n\r\n          -  History of participation in high school athletics\r\n\r\n          -  Signed Informed Consent form\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of ACL injury\r\n\r\n          -  Current/ongoing knee condition\r\n\r\n          -  History of surgical intervention within one year (not including facial)\r\n\r\n          -  Current/ongoing musculoskeletal injury\r\n\r\n          -  History of previous ACL prevention training\r\n\r\n          -  Currently involved in intercollegiate athletics\r\n\r\n          -  Currently Pregnant\r\n      ","sponsor":"Ohio University","sponsor_type":"Other","conditions":"ACL|Anterior Cruciate Ligament Injury","interventions":[{"intervention_type":"Procedure","name":"Procedure: Neuromuscular and Resistance Training","description":"1 hour/session, 3 sessions/week, 6 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Change in Knee separation during the Drop Jump Test","time_frame":"1 week prior to training begins, and 1 week after training finishes.","description":"Participants will begin the test by standing on a box, dropping off, landing straight in front of the box, and immediately performing a maximum vertical jump. Following the completion of the three trials, the examiner chooses the trial in which the participant has the highest jump to best represent the participant's jumping ability for video analysis. The following images will be captured as still photographs: (1) pre-landing; (2) land; and (3) takeoff."},{"outcome_type":"secondary","measure":"Changes in Vertical Jump Test","time_frame":"1 week prior to training begins, and 1 week after training finishes","description":"Each participant's standing reach will be recorded prior to performing the test. The participants will perform three trials, with the highest jump height being recorded. Participants will begin the test by standing directly underneath the Vertec markers and jumping vertically while reaching with their hand to swipe the highest marker possible. Arm swing will be allowed for the jump, but an approach-step will not."}]}
{"nct_id":"NCT01409720","start_date":"2011-09-30","phase":"Phase 2","enrollment":60,"brief_title":"Isometric Muscle Training in Patients With Spinal Bony Metastases Under Radiation Therapy","official_title":"Isometric Muscle Training of the Spine Musculature in Patients With Spinal Bony Metastases Under Radiation Therapy","primary_completion_date":"2012-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-09-30","last_update":"2014-03-20","description":"Standard indications for palliative radiation of bony metastases include pain, spinal cord compression, and impending pathologic fractures. Palliative radiation therapy serves to reduce pain, improve quality of life, and avoid complications. Tailored training of the paravertebral musculature may support radiation therapy and improve above named factors. DISPO was designed to investigate the impact of tailored physical exercise in patients with vertebral metastases as compared to manual therapy (massage etc.). The trial includes patients with painful bony metastases, patients with spinal cord compression or impending pathological fractures are excluded. The investigations are carried out in a prospective randomized controlled phase-II parallel group design.","other_id":"DISPO","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  solitary or multiple vertebral metastases\r\n\r\n          -  thoracic spine\r\n\r\n          -  lumbar spine\r\n\r\n          -  sacrum\r\n\r\n          -  indication for palliative radiation therapy\r\n\r\n          -  age: 18 - 80 years\r\n\r\n          -  Karnofsky index > 70%\r\n\r\n          -  bisphosphonate therapy inititated\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  bony metastases of cervical spine or pelvis\r\n\r\n          -  impending fracture\r\n\r\n          -  other serious illnesses or medical conditions: therapy-refractory unstable heart\r\n             disease, congestive heart failure NYHA III and IV; coagulopathies\r\n\r\n          -  Significant neurological or psychiatric condition including dementia or seizures or\r\n             other serious medical condition prohibiting the patient's participation in the trial\r\n             by judgement of the investigators\r\n\r\n          -  Legal incapacity or limited legal capacity\r\n\r\n          -  Positive serum/ urine beta-HCG/ pregnancy\r\n      ","sponsor":"Heidelberg University","sponsor_type":"Other","conditions":"Vertebral Bony Metastases","interventions":[{"intervention_type":"Other","name":"Other: exercise","description":"tailored isometric physical exercise"}],"outcomes":[{"outcome_type":"secondary","measure":"Fatigue","time_frame":"12 and 24 weeks post completion of therapy","description":"Fatigue is assessed using the EORTC FA13 questionnaire"},{"outcome_type":"primary","measure":"feasibility of isometric exercise in vertebral bony metastases","time_frame":"12 weeks post completion of radiotherapy","description":"safety and feasibility of isometric exercise in vertebral bony metastases"},{"outcome_type":"secondary","measure":"progression-free survival (PFS)","time_frame":"2 years post completion of radiotherapy","description":"PFS is assessed 2 years post completion of radiotherapy"},{"outcome_type":"secondary","measure":"fracture-free survival (FFS)","time_frame":"2 years post completion of radiotherapy","description":"FFS is assessed 2 years post completion of radiotherapy"},{"outcome_type":"secondary","measure":"bone density","time_frame":"12 weeks post completion radiotherapy","description":"bone density is assessed 12 weeks post completion of radiotherapy using follow-up CT scan of the spine"},{"outcome_type":"secondary","measure":"pain reduction","time_frame":"end of treatment, 12 and 24 weeks post completion of radiotherapy","description":"pain is evaluated using the VAS pain scale (0-100 points) at completion and 12/ 24 weeks post completion of radiation therapy"},{"outcome_type":"secondary","measure":"Quality of life","time_frame":"12 and 24 weeks post completion of therapy","description":"Quality of life is assessed using the EORTC BM22 questionnaire at 12 and 24 weeks post completion of treatment"}]}
{"nct_id":"NCT01590537","start_date":"2011-09-30","enrollment":2348,"brief_title":"Non-interventional Study of Long-term Intrauterine Contraceptives Acceptability and User Satisfaction","official_title":"Prospective Multicentre Non-interventional Comparative Study of Long-term Intrauterine Contraceptives Acceptability and User Satisfaction","primary_completion_date":"2014-03-31","study_type":"Observational","rec_status":"Completed","completion_date":"2014-10-31","last_update":"2015-10-16","description":"This is local prospective, non-interventional multi-center comparative study. Primary study objective is evaluation of the user satisfaction with Mirena or Copper IUD up to 1 year after insertion ( patient assessment questionnaire) in daily practice. For each patient, the treating gynecologist documents demographics, medical data, safety parameters and treatment signs and symptoms at an initial visit and one or two follow-up visit(s).","other_id":"15508","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"Female","minimum_age":20,"maximum_age":40,"population":"Females who plan long-term contraception and meet criteria of inclusion and exclusion.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Women 20-40 years old\r\n\r\n          -  Parity  1 child\r\n\r\n          -  Requesting long-term contraception\r\n\r\n          -  Written informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  in accordance with the current leaflet\r\n      ","sponsor":"Bayer","sponsor_type":"Industry","conditions":"Contraception","interventions":[{"intervention_type":"Drug","name":"Drug: Levonorgestrel (Mirena, BAY86-5028)","description":"intrauterine system containing 52 mg levonorgestrel, with daily release of 20 mcg levonorgestrel"},{"intervention_type":"Device","name":"Device: Copper IUD","description":"Copper device, inserted intrauterine"}],"outcomes":[{"outcome_type":"primary","measure":"User satisfaction of the contraception method with Mirena or Copper IUD","time_frame":"up to 12 months"},{"outcome_type":"secondary","measure":"Safety evaluation of Mirena or Copper IUD in routine practice Safety parameters include number of AEs, severity,relationship to Mirena or Cooper IUD","time_frame":"up to 12 months"},{"outcome_type":"secondary","measure":"Contraceptive reliability of Mirena or Cooper IUD in routine practice ( fixing number of pregnancies)","time_frame":"up to 12 months"},{"outcome_type":"secondary","measure":"Continuation/discontinuation rate ( number of cases with contraceptive method continuation and discontinuations)","time_frame":"up to 12 months"},{"outcome_type":"secondary","measure":"Relationship between different parameters and women preferences in choosing Mirena or Cooper IUD as their contraceptive method ( demographic parameters, age group, residence, reproductive history and plans, etc.) using patients questionnaire","time_frame":"up to 12 months"}]}
{"nct_id":"NCT01456611","start_date":"2011-09-30","phase":"Phase 3","enrollment":749,"brief_title":"Evaluation of Clinical Endpoints of Two Diclofenac Sodium Gel 1%","official_title":"A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Evaluate the Clinical Equivalence of Diclofenac Sodium 1% Gel (Anchen Pharmaceuticals, Inc.) With Voltaren Gel (Diclofenac Sodium Topical Gel) 1% (Novartis) in Patients With Osteoarthritis of the Knee","primary_completion_date":"2012-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-04-30","last_update":"2012-07-12","description":"The objective of this study is to evaluate the clinical equivalence and safety of the Test formulation of diclofenac sodium topical gel 1% (Anchen Pharmaceuticals, Inc.) compared to the marketed formulation Voltaren Gel (diclofenac sodium topical gel) 1% (Novartis) in patients with osteoarthritis of the knee. The efficacy of both the Test and Reference formulations will also be compared to the Placebo gel to determine Superiority.","other_id":"DCL-269","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":35,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        1. Ambulatory Male and Non Pregnant Females 35 years and older diagnosed with\r\n        osteoarthritis (according to the American College of Rheumatology Criteria) in one or both\r\n        knees.\r\n\r\n        ACR Criteria includes, Knee Pain and at least 3 of the following:\r\n\r\n          1. age  50\r\n\r\n          2. stiffness lasting < 30 mins\r\n\r\n          3. bony tenderness\r\n\r\n          4. crepitus\r\n\r\n          5. bony enlargement\r\n\r\n          6. no palpable warmth\r\n\r\n        2. Symptom onset of > 6 Months prior to Screening for the target knee.\r\n\r\n        3. If female and of child-bearing potential, prepare to abstain from sexual intercourse or\r\n        use a reliable method of contraception during the study (e.g., condom + spermicide, IUD,\r\n        oral, transdermal, injected or implanted hormonal contraceptives).\r\n\r\n        4. Periarticular knee pain due to osteoarthritis (not bursitis, tendonitis etc) requiring\r\n        the use of oral or topical treatments (NSAIDS or acetaminophen) for > 15 days in the 30\r\n        days prior to Screening.\r\n\r\n        5. Radiograph of the target knee within the previous year with a Grade 1, 2 or 3 disease\r\n        based upon the Kellgren-Lawrence disease severity scale.\r\n\r\n        6. After a 7 day wash out of all pain medication has baseline pain on movement score of \r\n        50mm on a 100-mm Visual Analogue Scale for the target knee.\r\n\r\n        7. After a 7 day wash out of all pain medication has baseline WOMAC pain sub scale of  9\r\n        on a 5 question, 5 point (0 to 4) Likert scale for the target knee.\r\n\r\n        8. Willing and able to use only acetaminophen as rescue medication\r\n\r\n        9. Willing and able to comply with the study requirements.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Females who are pregnant, breast feeding, or planning a pregnancy\r\n\r\n          2. Radiograph of the target knee within the previous year with a Grade 4 score on the\r\n             Kellgren-Lawrence disease severity scale. 24\r\n\r\n          3. History of osteoarthritis in the contralateral knee requiring medication (OTC or\r\n             prescription) within 12 months of screening.\r\n\r\n          4. After a 7 day wash out of all pain medication has baseline pain on movement score of \r\n             20mm on a 100-mm Visual Analogue Scale for the contralateral knee immediately prior to\r\n             randomization.\r\n\r\n          5. Known history of secondary osteoarthritis (e.g. congenital, traumatic, gouty\r\n             arthritis) or rheumatoid arthritis.\r\n\r\n          6. Known history of other chronic inflammatory diseases, (e.g.,colitis) or fibromyalgia.\r\n\r\n          7. History of asthma, hypertension, myocardial infarction, thrombotic events, stroke,\r\n             congestive heart failure, impaired renal function or liver disease.\r\n\r\n          8. History of coronary artery bypass graft within 6 months of screening.\r\n\r\n          9. Concomitant acetylsalicylic acid therapy other than a stable low dose used for cardiac\r\n             prophylaxis (max 162mg daily) taken for at least 3 months prior to enrollment and\r\n             maintained throughout the duration of the study.\r\n\r\n         10. Use of warfarin or other anticoagulant therapy within 30 days of screening.\r\n\r\n         11. Use of ACE inhibitors, cyclosporine, diuretics, lithium or methotrexate, within 30\r\n             days of screening or during the study.\r\n\r\n         12. Known history of gastrointestinal bleeding or peptic ulcer disease.\r\n\r\n         13. Abnormal screening clinical laboratory evaluations which the Investigator determines\r\n             are clinically significant.\r\n\r\n         14. Known allergy to aspirin or NSAIDs.\r\n\r\n         15. Results from liver function tests that are more than two times the upper limit of the\r\n             normal range at screening.\r\n\r\n         16. Any other acute or chronic illness that in the opinion of the investigator could\r\n             compromise the integrity of study data or place the Patient at risk by participating\r\n             in the study.\r\n\r\n         17. Concomitant use of corticosteroids (any formulation) or use within 30 days of study\r\n             randomization.\r\n\r\n         18. Receipt of any drug as part of a research study within 30 days prior to screening.\r\n\r\n         19. Previous participation in this study.\r\n      ","sponsor":"Anchen Pharmaceuticals, Inc","sponsor_type":"Industry","conditions":"Osteo Arthritis of the Knee","interventions":[{"intervention_type":"Drug","name":"Drug: Diclofenac","description":"Diclofenac Sodium Gel 1%"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo Topical Gel"}],"outcomes":[{"outcome_type":"primary","measure":"Mean Change from Baseline in WOMAC Pain Scale","time_frame":"Baseline and Week 4"},{"outcome_type":"secondary","measure":"Superiority of Test and Reference against Placebo in the Mean Change from baseline in the total WOMAC pain score.","time_frame":"Baseline and Week 4","description":"The superiority of treatment over the placebo will be concluded if the treatment's mean change from baseline in the total WOMAC pain score is statistically significantly greater (p<0.05) than that of the placebo in the ANCOVA based on the treatment and placebo results. The superiority of Test and Reference treatments over the placebo will be evaluated identically in a separate ANCOVA.\r\nThe analyses will be conducted in the mITT population."}]}
{"nct_id":"NCT01438333","start_date":"2011-09-30","phase":"N/A","enrollment":15,"brief_title":"Efficacy of INERSAN in Patients With Chronic Periodontitis as Adjunctive to Full Mouth Disinfection","official_title":"Efficacy of INERSAN in Patients With Chronic Periodontitis as Adjunctive to Full Mouth Disinfection: a Randomized, Double Masked, Placebo Controlled Clinical Trial","primary_completion_date":"2015-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-03-31","last_update":"2015-06-17","description":"The purpose of this study is to evaluate beneficial effects of probiotic Lactobacillus brevis CD2 tablets in addition to the primary treatment for patients with chronic periodontitis (Full Mouth Disinfection), at local level and at systemic level.","other_id":"07/CE/2011","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":21,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients between 21-70 years of age groups;\r\n\r\n          -  patients with chronic periodontitis in need of primary treatment;\r\n\r\n          -  patients with at least 20 fully erupted teeth;\r\n\r\n          -  patients ready to give written informed consent for participating in the trial;\r\n\r\n          -  patients agreeing to comply with the study protocol and instructions.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnant women and lactating mothers;\r\n\r\n          -  patients with debilitating systemic diseases;\r\n\r\n          -  patients in needs for prophylactic antibiotics;\r\n\r\n          -  patients treated with antibiotics within 30 days prior to enrollment into the study;\r\n\r\n          -  patients already participant any other clinical trial or participant other\r\n             investigational drug, or food supplement, in the last 30 days;\r\n\r\n          -  patient having active periapical abscess or periodontal abscess or a history of acute\r\n             necrotizing ulcerative gingivitis;\r\n\r\n          -  patients not willing to participate in the trial.\r\n\r\n          -  patients with psychiatric problems.\r\n      ","sponsor":"University of L'Aquila","sponsor_type":"Other","conditions":"Chronic Periodontitis","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: lactobacillus brevis tablets","description":"5 tablets a day for 6 weeks"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: PLACEBO","description":"5 tablets a day for 6 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Comparison in saliva and gingival crevicular fluid samples of the levels of Matrixmetalloproteinases (MMPs)","time_frame":"6 weeks"},{"outcome_type":"primary","measure":"Comparison in saliva and gingival crevicular fluid samples of the levels of modulators of inflammatory reaction (interleukin 1beta, interleukin 10, prostaglandin 2)","time_frame":"6 weeks"},{"outcome_type":"primary","measure":"Comparison in saliva samples of the levels of metabolic phenotype","time_frame":"6 weeks"},{"outcome_type":"secondary","measure":"Comparison in saliva samples of the levels of Nitric Oxide Synthase (NOS) activity;","time_frame":"6 weeks"},{"outcome_type":"secondary","measure":"Comparison in saliva samples of the levels of Arginine deiminase","time_frame":"6 weeks"},{"outcome_type":"secondary","measure":"Comparison in saliva samples of the levels of lactoferrin","time_frame":"6 weeks"},{"outcome_type":"secondary","measure":"Comparison in saliva and gingival crevicular fluid samples of the levels of subgingival bacteria (Aggregatibacter Actinomycetemcomitan, Porphyromonas gingivalis, Tannerella Forsythia, Treponema denticola)","time_frame":"6 weeks"},{"outcome_type":"secondary","measure":"Comparison in breath samples of the levels of Volatile Sulfur Compounds (VSC)(hydrogen sulfide, methyl mercaptan, dimethyl sulfide)","time_frame":"6 weeks"},{"outcome_type":"secondary","measure":"Comparison in blood samples of the levels of Toll Like Receptor-2 and Toll Like Receptor-4 positive B-cells","time_frame":"6 weeks"}]}
{"nct_id":"NCT01787006","start_date":"2011-09-30","phase":"Phase 2","enrollment":74,"brief_title":"Definitive Radiochemotherapy Plus/Minus Cetuximab in Unresectable Locally Advanced Esophageal Cancer","official_title":"Definitive Radiochemotherapy With 5-FU / Cisplatin Plus/Minus Cetuximab in Unresectable Locally Advanced Esophageal Cancer: a Phase II Study","primary_completion_date":"2018-09-06","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-09-06","last_update":"2020-03-10","description":"Esophageal cancer is a highly aggressive tumor. Treatment options are various and range from chemotherapy to radiotherapy and several surgical techniques. Nevertheless, the overall survival rates for this disease remain poor. During the last years the combination of cetuximab with standard chemotherapy or radiotherapy has mainly be investigated in clinical trials focusing on colorectal and/or head and neck cancer. The results obtained from theses studies were very encouraging and led to the initiation of active clinical research in esophageal cancer patients with antibody inhibition of the epidermal growth factor receptor (EGFR). The first data in this indication are encouraging showing that cetuximab can safely be added to chemoradiation for esophageal cancer patients with first hints of efficacy. Based on the experiences with cetuximab in colorectal cancer and in combination with radiotherapy in head and neck cancer, the aim of the present study is to evaluate the feasibility of a combined treatment of cetuximab with continuous infusional 5-FU, cisplatin and radiotherapy in patients with esophageal cancer and to assess if the overall survival rates can be increased by addition of an EGFR-targeted therapy.","other_id":"LEOPARD II","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Dated and signed written informed consent\r\n\r\n          -  Male or female patients between 18 years and 75 years; patients > 75 years if their\r\n             karnofsky performance status is  80.\r\n\r\n          -  Histologically proven squamous cell carcinoma or adenocarcinoma of the esophagus which\r\n             is not curatively resectable. Resectability has to be defined by a surgeon before\r\n             radiochemotherapy. The tumor is considered unresectable due to T-stage, N-stage,\r\n             performance status, nutritional status, co-morbidity (pulmonal function, other), tumor\r\n             location upper third or other reasons\r\n\r\n          -  Karnofsky Performance Status  70\r\n\r\n          -  Women of child-bearing potential must have a negative pregnancy test\r\n\r\n          -  Adequate cardial-, pulmonal- and ear function\r\n\r\n        Adequate bone marrow function:\r\n\r\n          -  leukocytes  3.0 x 10^9/L\r\n\r\n          -  neutrophiles  1.5 x 10^9/L\r\n\r\n          -  thrombocytes  100 x 10^9/L\r\n\r\n          -  hemoglobin  10.0 g/dl\r\n\r\n        Adequate liver function:\r\n\r\n          -  bilirubin  2.0 mg/dl\r\n\r\n          -  transaminases (serum glutamic pyruvic transaminase (SGPT), serum glutamic oxaloacetic\r\n             transaminase (SGOT), gamma-GT)  3 x upper limit of normal (ULN)\r\n\r\n        Adequate kidney function:\r\n\r\n          -  serum creatinine  1.5 mg/dl\r\n\r\n          -  creatinine clearance  50 ml/min according to Cockcroft-Gault Formula\r\n\r\n          -  no known allergies against chimeric antibodies\r\n\r\n          -  effective contraception for male and female patients if there is a risk of conception\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  distant metastasis\r\n\r\n          -  previous treatment of esophageal cancer\r\n\r\n          -  previous therapy with monoclonal antibodies and / or EGFR-targeted therapy\r\n\r\n          -  previous second malignancies with exception of a history of a previous curatively\r\n             treated basal cell carcinoma of the skin or pre-invasive cervix carcinoma\r\n\r\n          -  serious concomitant disease or medical condition\r\n\r\n          -  lung function: forced expiratory volume in one second (FEV1)) < 1.1\r\n\r\n          -  clinically relevant coronary artery diseases or known myocardial infarction within the\r\n             last 12 months or ventricular ejection fraction (LVEF) below normal\r\n\r\n          -  every active dermatological condition > grade 1\r\n\r\n          -  contraindications to receive cisplatin, 5-FU or cetuximab\r\n\r\n          -  concurrent treatment with other experimental drugs or participation in another\r\n             clinical trial within 30 days before study start\r\n\r\n          -  patient pregnant or breast feeding\r\n\r\n          -  known drug abuse, medication abuse, alcohol abuse\r\n\r\n          -  social situations limiting the compliance with the study requirements\r\n      ","sponsor":"University Hospital Schleswig-Holstein","sponsor_type":"Other","conditions":"Esophageal Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Cetuximab","description":"Initial doses 400mg/m2 (day 1), followed by weekly doses of 250mg/m2 for 14 weeks in total"},{"intervention_type":"Drug","name":"Drug: Cisplatin, 5-FU","description":"5-FU: 1000mg/m2 per day as continuous infusion on day 1-4 of cycle 1 and 2, 750mg/m2/day as continuous infusion on day 1-4 of cycle 3 and 4\r\nCisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle"},{"intervention_type":"Radiation","name":"Radiation: Radiotherapy","description":"59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery."}],"outcomes":[{"outcome_type":"primary","measure":"Rate of Participants Who Were Alive at 2 Years","time_frame":"2 years","description":"Overall Survival (OS) was defined as freedom from death of any cause. Time to death was calculated from the day of randomization, and the patients were followed for a maximum of 24 months (2 years)."},{"outcome_type":"secondary","measure":"Rate of Participants Who Were Alive at 1 Year","time_frame":"1 year","description":"Overall Survival (OS) was defined as freedom from death of any cause. Time to death was calculated from the day of randomization."},{"outcome_type":"secondary","measure":"Rate of Participants Who Were Alive Without Progression of Disease at 1 Year","time_frame":"1 year","description":"For progression-free survival (PFS), the event was defined as first occurrence of radiologically proven progression or clinical progression or death due to progressive disease. Time to event was referenced from the day of randomization."},{"outcome_type":"secondary","measure":"Rate of Participants Who Were Alive Without Progression of Disease at 2 Years","time_frame":"2 years","description":"For progression-free survival (PFS), the event was defined as first occurrence of radiologically proven progression or clinical progression or death due to progressive disease. Time to event was referenced from the day of randomization."},{"outcome_type":"secondary","measure":"Number of Participants Experiencing at Least One Grade >=3 Toxicity","time_frame":"up to 2 years","description":"Toxicity was assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) (version 4.03)."},{"outcome_type":"secondary","measure":"Rate of Participants Who Were Alive Without Distant Metastases at 1 Year","time_frame":"1 year","description":"For metastases-free survival (MFS), the event was defined as first occurrence of distant metastasis. Time to event was referenced from the day of randomization."},{"outcome_type":"secondary","measure":"Rate of Participants Who Were Alive Without Distant Metastases at 2 Years","time_frame":"2 years","description":"For metastases-free survival (MFS), the event was defined as first occurrence of distant metastasis. Time to event was referenced from the day of randomization."},{"outcome_type":"secondary","measure":"Number of Participants Who Achieved at Least Partial Response (Responders)","time_frame":"up to 2 years","description":"Response was defined according to the RECIST criteria (Version 1.1) based on the assessments (computed tomography, magnetic resonance imaging or other) for target lesions, non-target lesions as well as considering the occurrence of new lesions.\r\nThe best overall response (RECIST) was chosen for each patient out of all valid tumour assessments before start of next-line therapy (complete response=CR being the best and progressive disease=PD the worst). Frequencies with percentages were to be given for each category (CR, partial response (PR), stable disease (SD), PD) by treatment group. The data were to be presented as the dichotomous endpoint of objective response, for which patients with best overall response of CR or PR were considered as responders, and those with best overall response of SD or PD as non-responders. The difference between objective response rates in the two treatment arms was to be compared with a Chi-square test."},{"outcome_type":"secondary","measure":"Rate of Participants Who Were Alive Without Loco-regional Failure at 1 Year","time_frame":"1 year","description":"Loco-regional failure was defined as progressive primary tumor and/or regional lymph nodes on endoscopy, endoscopic ultrasound or computed tomography.Time to event was referenced from the day of randomization."},{"outcome_type":"secondary","measure":"Rate of Participants Who Were Alive Without Loco-regional Failure at 2 Years","time_frame":"2 years","description":"Loco-regional failure was defined as progressive primary tumor and/or regional lymph nodes on endoscopy, endoscopic ultrasound or computed tomography. Time to event was referenced from the day of randomization."},{"outcome_type":"secondary","measure":"Change in Quality of Life Between Baseline and End of Treatment (After 5 to 13 Weeks)","time_frame":"end of treatment (after 5 to 13 weeks)","description":"Quality of Life was assessed with EORTC QLQ-C30 and QLQ-OES18 questionnaires. For QLQ-C30, global health status, functional scales (physical, role, emotional, cognitive and social functioning) and symptom scales (fatigue, nausea/vomiting, pain, dyspnea, loss of appetite, constipation, diarrhea, financial difficulties) were calculated. Scores ranged from 0 to 100; higher scores represented higher levels of quality of life, functioning, or symptoms/problems. Score were calculated using mean values.\r\nFor QLQ-OES18, symptom scales (problems with eating, reflux, pain, problems swallowing saliva, dry mouth, taste disorders, problems while coughing or speaking) and functional scale (dysphagia) were assessed the same way.\r\nA change between two time points, i.e. baseline (prior to treatment) and end of treatment (after 5 to 13 weeks, depending on treatment arm (6.5 weeks without and 13 weeks with cetuximab) and achievement of resectability (end of treatment after 5 weeks), is reported."}]}
{"nct_id":"NCT01695200","start_date":"2011-09-30","phase":"Phase 4","enrollment":60,"brief_title":"Omega-3 Fatty Acids in Autism Spectrum Disorders","official_title":"The Role of Omega-3 Fatty Acids in the Management of Singaporean Children With Autism Spectrum Disorders","primary_completion_date":"2013-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-01-31","last_update":"2013-05-01","description":"This is a 12-week open label trial to evaluate whether omega-3 fatty acids is effective in reducing the severity of autism and its comorbidities.","other_id":"DSRB: 2011/00028","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":5,"maximum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Between ages 5 and 18 years old\r\n\r\n          -  Diagnosed to have Autism, Asperger Syndrome, or PDDNOS by the DSM-IV criteria; met the\r\n             Autism or Spectrum classification for Autism Diagnostic Interview - Revised (ADI-R)\r\n             and Autism Diagnostic Observation Schedule (ADOS)\r\n\r\n          -  Written parental consent for participation\r\n\r\n          -  Those not on current standard-of-care treatments for ASD\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Below 5 and above 18 years old\r\n\r\n          -  No formal diagnosis of Autism, Asperger Syndrome or PDD-NOS\r\n\r\n          -  Without written parental consent for participation\r\n\r\n          -  Those with brain pathology such as serious head injury, epilepsy, etc.\r\n\r\n          -  Those on current standard-of-care treatment for ASD\r\n\r\n          -  Those with psychotic symptoms, self-injurious behaviours and/or suicidal tendency, and\r\n             other history of clinically significant medical conditions screened by the attending\r\n             doctor to have increase the risk associated with study participation\r\n\r\n          -  Those on other types of medication or supplements or with change in dose\r\n      ","sponsor":"National Healthcare Group, Singapore","sponsor_type":"Other","conditions":"Autism Spectrum Disorders","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Omega-3 fatty acids"}],"outcomes":[{"outcome_type":"primary","measure":"Change from baseline in parent rated Social Responsiveness Scale (SRS) scores during treatment","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"Change from baseline in parent rated Child Behavior Checklist (CBCL) scores during treatment","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"Change from baseline in teacher rated Teacher Report (TRF) scores during treatment","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"Change from baseline in teacher rated Social Responsiveness Scale (SRS) scores during treatment","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"Change from baseline in clinician rated Clinical Global Impression (Severity and Improvements) scores during treatment","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"Change from baseline in clinician rated Global Assessment of Functioning (GAF) scores during treatment","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"Children's Yale-Brown Obsessive Compulsive Scale modified for Pervasive Developmental Disorders (CYBOCS-PDD)","time_frame":"12 weeks"},{"outcome_type":"other","measure":"Assessment of plasma fatty acid composition, measurements of DHA and EPA (components of omega-3), and total phospholipid count","time_frame":"12 weeks"},{"outcome_type":"other","measure":"Assessment of dietary intake and nutritional intake of the child","time_frame":"12 weeks"}]}
{"nct_id":"NCT02397031","start_date":"2011-09-30","phase":"N/A","enrollment":64,"brief_title":"Mindfulness and Interpersonal Effectiveness Skills in Borderline Personality Disorder","official_title":"Randomized, Active-controlled, Clinical Trial Comparing Effects of Mindfulness and Interpersonal Effectiveness Skills in Borderline Personality Disorder","primary_completion_date":"2014-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-04-30","last_update":"2015-03-25","description":"The purpose of the study was to determine whether mindfulness training could be more effective than another active intervention in reducing borderline personality disorder (BPD) symptoms. The main hypothesis was that patients allocated to the mindfulness group would show a greater improvement on global BPD symptomatology. As a second objective, we explored some of the possible underlying mechanisms of both active treatments. For that purpose, changes in decentering, mindfulness facets and cognitive processing of social interactions were also evaluated.","other_id":"IIBSP-MOD-2011-147","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion criteria:\r\n\r\n          -  Ages between 18 and 45 years\r\n\r\n          -  BPD criteria according to two diagnostic interviews (SCID-II and DIB-R)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Lifetime diagnosis of schizophrenia, drug-induced psychosis, organic brain syndrome,\r\n             bipolar disorder or mental retardation\r\n\r\n          -  Participating in any sort of psychotherapy during the study or having participated in\r\n             dialectical behavioral therapy groups in the past\r\n      ","sponsor":"Fundaci Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau","sponsor_type":"Other","conditions":"Borderline Personality Disorder","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Mindfulness","description":"weekly psychotherapy sessions for 10 weeks (120 min each)"},{"intervention_type":"Behavioral","name":"Behavioral: interpersonal effectiveness","description":"weekly psychotherapy sessions for 10 weeks (120 min each)"}],"outcomes":[{"outcome_type":"primary","measure":"change from baseline in borderline symptoms after a 10 week intervention","time_frame":"10 weeks","description":"participants were assessed pre and post interventions"},{"outcome_type":"secondary","measure":"change from baseline in decentering after a 10 week intervention","time_frame":"10 weeks","description":"participants were assessed pre and post interventions"},{"outcome_type":"secondary","measure":"change from baseline in mindfulness facets after a 10 week intervention","time_frame":"10 weeks","description":"participants were assessed pre and post interventions"},{"outcome_type":"secondary","measure":"change from baseline in social interactions after a 10 week intervention","time_frame":"10 weeks","description":"participants were assessed pre and post interventions"}]}
{"nct_id":"NCT01416220","start_date":"2011-09-30","phase":"Phase 4","enrollment":2,"brief_title":"Lithium Versus Paroxetine in Major Depression","official_title":"A Randomized, Open-label, Trial of Lithium Versus Paroxetine in Subjects With Major Depression Who Have a Family History of Bipolar Disorder or Completed Suicide","primary_completion_date":"2013-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-02-28","last_update":"2020-07-16","description":"This study is being done to look at how well people respond to two different drug treatments for depression. Clinically, people can respond differently to different treatments for reasons which are not always clear. Some research shows that people with a family history of bipolar disorder or completed suicide may react differently to standard medications used to treat depression than those without a family history. The investigators need to know if these drugs are effective to use in patients with depression who have a family history of bipolar disorder or completed suicide.","other_id":"MoodDig-001","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  men or women\r\n\r\n          -  age of 18 years or older\r\n\r\n          -  meet criteria for major depressive episode, and have a family history of bipolar\r\n             disorder or completed suicide\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  subjects not able to give informed consent\r\n\r\n          -  pregnant or breast-feeding women\r\n\r\n          -  current panic disorder, post traumatic stress disorder or psychosis\r\n\r\n          -  subjects with a history of mania or hypomania\r\n\r\n          -  subjects with active substance abuse or dependence in the last 6 months\r\n\r\n          -  current depressive episode less than 4 weeks or greater than 12 months in duration\r\n\r\n          -  adequate trial of lithium or paroxetine (lithium level  0.6mmols/l; paroxetine 20mgs\r\n              5 weeks) for this episode of depression\r\n\r\n          -  concurrent use of other antidepressants or augmenting agents for the treatment of\r\n             depression\r\n\r\n          -  clinically significant medical illness, in particular renal impairment\r\n      ","sponsor":"Nova Scotia Health Authority","sponsor_type":"Other","conditions":"Major Depressive Disorder","interventions":[{"intervention_type":"Drug","name":"Drug: Lithium","description":"Study drug will be packaged and supplied in an open-label fashion. There will be a washout period of all active psychotropic medication. Psychotropics will be withdrawn over 5 half-lives with the exception of drugs known to cause withdrawal symptoms (primarily antidepressants), which will be tapered over 10 days.\r\nFollowing the enrollment period, subjects will enter a six-week randomized treatment period with either lithium or paroxetine. Lithium carbonate will be commenced at 600mgs hs, with increase to 900mgs at day 7. Dose will be flexibly titrated to give a serum level between 0.5 and 1.1mmol/l. At visit 4, the dose of lithium may be adjusted (within the range of 0.6 and 1.1 mmol/l."},{"intervention_type":"Drug","name":"Drug: Paroxetine","description":"Study drug will be packaged and supplied in an open-label fashion. There will be a washout period of all active psychotropic medication. Psychotropics will be withdrawn over 5 half-lives with the exception of drugs known to cause withdrawal symptoms (primarily antidepressants), which will be tapered over 10 days.\r\nFollowing the enrollment period, subjects will enter a six-week randomized treatment period with either lithium or paroxetine. Paroxetine will be commenced at 10mgs and increased to 20mgs on day 7. At visit 4, the dose of paroxetine may be increased to 40mgs, if there is no response (less than 20% reduction in MADRS score) as per current Canadian guidelines."}],"outcomes":[{"outcome_type":"primary","measure":"Montgomery Asberg Depression Rating Scale (MADRS)","time_frame":"Assessed after 6 weeks of treatment","description":"The primary outcome measure will be reduction in the score on the Montgomery Asberg Depression Rating Scale (MADRS), which has become the standard outcome tool in clinical trials for assessing symptoms of depression. Response will be defined as 50% reduction in MADRS Remission will be defined as MADRS ≤ 12."},{"outcome_type":"secondary","measure":"The Young Mania Rating Scale (YMRS)","time_frame":"Assessed after 6 weeks of treatment","description":"This is a standard outcome tool used to assess mania."},{"outcome_type":"secondary","measure":"The Clinical Global Impression (CGI)","time_frame":"Assessed after 6 weeks of treatment","description":"The Clinical Global Impression (CGI)is a scale used to measure overall symptom severity, treatment response, and treatment efficacy in patients with mood disorders."},{"outcome_type":"secondary","measure":"The Columbia Suicide Classification Scale","time_frame":"Assessed over 6 weeks of treatment.","description":"The Columbia Suicide Classification Scale, used in the FDA analysis of pediatric antidepressants, has become a standard tool used in clinical depression trials and will be used to monitor changes in suicide risk or self-harm weekly."},{"outcome_type":"secondary","measure":"Barnes Akathisia Rating Scale (BARS)","time_frame":"Assessed over 6 weeks of treatment","description":"Barnes Akathisia Rating Scale (BARS):\r\nThe BARS is a very brief clinical assessment for the presences of akathisia. Akathisia secondary to antidepressants has been associated with increased suicidality. The inclusion of the BARS will serve to delineate akathisia from psychomotor agitation as part of treatment -emergent mixed symptoms."},{"outcome_type":"secondary","measure":"Treatment -emergent symptom checklist and questionnaire","time_frame":"Assessed over 6 weeks of treatment","description":"This checklist and questionnaire will be used to capture a potential range of treatment emergent mixed symptoms."}]}
{"nct_id":"NCT01347645","start_date":"2011-09-30","phase":"Phase 1/Phase 2","enrollment":82,"brief_title":"Irinotecan Plus E7820 Versus FOLFIRI in Second-Line Therapy in Patients With Locally Advanced or Metastatic Colon or Rectal Cancer","official_title":"An Open-Label, Multicenter, Randomized Phase Ib/II Study of Irinotecan Plus E7820 Versus FOLFIRI in Second-Line Therapy in Patients With Locally Advanced or Metastatic Colon or Rectal Cancer","primary_completion_date":"2015-06-22","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-06-22","last_update":"2017-08-28","description":"The purpose of the Phase Ib portion is to find out the highest dose of study drug that can safely be given when tested in a small group of subjects. The purpose of the Phase II portion is to find out how safe the study drug is when taken at the highest dose in a larger group of subjects.","other_id":"E7820-702","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Patients may be entered in the study only if they meet all of the following criteria:\r\n\r\n          1. Male or female patient greater than or equal to 18 years of age;\r\n\r\n          2. Histologically or cytologically confirmed nonresectable locally advanced or metastatic\r\n             colorectal adenocarcinoma;\r\n\r\n          3. Patients must have failed a first-line chemotherapy regimen for nonresectable locally\r\n             advanced or mCRC (first-line 5-FU-based therapies, including but not limited to\r\n             FOLFOX, FOLFOX 4, mFOLFOX6, CapeOX, single-agent capecitabine, infusional 5-FU, or\r\n             other chemotherapies. Bevacizumab, cetuximab, panitumumab, and EGFR inhibitors are\r\n             allowed. Prior treatment with irinotecan or FOLFIRI is not allowed for Phase II). For\r\n             Phase Ib only, up to 3 prior therapies are allowed (including non-irinotecan\r\n             containing therapies and adjuvant therapy);\r\n\r\n          4. At least 1 site of measurable disease by the Response Evaluation Criteria in Solid\r\n             Tumors (RECIST version 1.1) criteria;\r\n\r\n          5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of less than or\r\n             equal to 2;\r\n\r\n          6. Patients must have adequate renal function as evidenced by serum creatinine less than\r\n             2 mg/dL and creatinine clearance greater than 50 mL/minute per the Cockcroft and Gault\r\n             formula;\r\n\r\n          7. Patients must have adequate bone marrow function as evidenced by absolute neutrophil\r\n             count (ANC) greater than or equal to 1.5 x 109/L, platelets greater than100 x 109/L,\r\n             hemoglobin greater than or equal to 9.0 g/dL (a hemoglobin less than 9.0 g/dL at\r\n             Screening is acceptable if it is corrected to greater than or equal to 9 g/dL by\r\n             growth factor or transfusion prior to the first dose);\r\n\r\n          8. Patients must have adequate liver function as evidenced by bilirubin less than or\r\n             equal to 1.5 times the upper limit of the normal range (ULN), and alkaline\r\n             phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less\r\n             than or equal to 3 X ULN (in the case of liver metastases, less than or equal to 5 X\r\n             ULN).If there are bone metastases, liver-specific alkaline phosphatase may be\r\n             separated from the total and used to assess liver function instead of total alkaline\r\n             phosphatase;\r\n\r\n          9. For patients with hypertension, it must be well controlled. If a patient presents with\r\n             poorly controlled hypertension, defined as a mean systolic blood pressure greater than\r\n             or equal to140 mm Hg or mean diastolic blood pressure greater than or equal to 90 mm\r\n             Hg,antihypertensive medication(s) should be initiated or adjusted with a goal to\r\n             control the blood pressure less than 140/90 mm Hg. Blood pressure must be reassessed\r\n             on 2 occasions, consecutively, that are separated by a minimum of 24 hours;\r\n\r\n         10. Male or female patients of child-producing potential must agree to use double barrier\r\n             contraception, oral contraceptives, or avoidance of pregnancy measures during the\r\n             study and for 90 days after the last day of treatment;\r\n\r\n         11. Females of childbearing potential must have a negative serum pregnancy test at\r\n             Screening;\r\n\r\n         12. Females may not be breastfeeding; Ability to understand and willingness to sign a\r\n             written informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Received chemotherapy, targeted therapy, radiotherapy, surgery, immunotherapy, or\r\n             treatment in another clinical study within the 30 days prior to commencing study\r\n             treatment or have not recovered from side effects of all treatment-related toxicities\r\n             to Grade less than or equal to 1, except for peripheral neuropathy (Grade 1 and Grade\r\n             2 are permitted) and alopecia;\r\n\r\n          2. Previously received irinotecan or irinotecan derivatives in Phase II\r\n             (irinotecan-containing regimens are allowed in Phase Ib);\r\n\r\n          3. Previously received anti-alpha 2 integrin therapy;\r\n\r\n          4. History of other malignancies except: (1) adequately treated basal or squamous cell\r\n             carcinoma of the skin; (2) curatively treated in situ carcinoma of the uterine cervix;\r\n             or (3) other curatively treated solid tumor with no evidence of disease for greater\r\n             than or equal to 5 years;\r\n\r\n          5. Presence of brain metastases, unless the patient has received adequate treatment at\r\n             least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids\r\n             for at least 4 weeks prior to randomization;\r\n\r\n          6. Are currently receiving any other anticancer treatment;\r\n\r\n          7. Serious non-healing wound, ulcer, or active bone fracture;\r\n\r\n          8. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days\r\n             prior to Day 1, or anticipation of need for a major surgical procedure during the\r\n             course of the study;\r\n\r\n          9. Refractory nausea and vomiting, malabsorption, significant bowel resection, or any\r\n             other medical condition that would preclude adequate absorption or result in the\r\n             inability to take oral medication;\r\n\r\n         10. Significant cardiovascular impairment (history of congestive heart failure New York\r\n             Heart Association [NYHA] Grade greater than 2, unstable angina or myocardial\r\n             infarction within the past 6 months, or serious cardiac arrhythmia);\r\n\r\n         11. Active hemoptysis (defined as bright red blood of 1/2 teaspoon or more) within the 30\r\n             days prior to study entry;\r\n\r\n         12. Current or recent use (within 7 days) of full-dose warfarin (except low-dose warfarin\r\n             as required to maintain patency of pre-existing, permanent indwelling IV catheters).\r\n             For patients receiving warfarin, International Normalization Ratio (INR) should be\r\n             less than 1.5. Patients may have prophylactic use of low molecular weight heparin;\r\n             however, therapeutic use of heparin or low molecular weight heparin is not acceptable;\r\n\r\n         13. History of bleeding diathesis or coagulopathy;\r\n\r\n         14. Any history of cerebral vascular accident, transient ischemic attack, or Grade greater\r\n             than or equal to 2 peripheral vascular disease, unless they have had no evidence of\r\n             active disease for at least 6 months prior to randomization;\r\n\r\n         15. Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6\r\n             months prior to Day 1, unless affected area has been removed surgically;\r\n\r\n         16. Patients with organ allografts requiring immunosuppression;\r\n\r\n         17. Known positive human immunodeficiency virus (HIV), known hepatitis B surface antigen,\r\n             or active hepatitis C positive;\r\n\r\n         18. Patients with a history of allergic reactions attributed to compounds of similar\r\n             chemical or biologic composition to irinotecan, 5-FU, or leucovorin;\r\n\r\n         19. Hypersensitivity to sulfonamide derivatives;\r\n\r\n         20. Have any medical condition that would interfere with the conduct of the study.\r\n      ","sponsor":"Eisai Inc.","sponsor_type":"Industry","conditions":"Colon Cancer|Rectal Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: FOLFIRI","description":"Comparator dose and mode of administration The FOLFIRI regimen consists of irinotecan at 180 mg/m2 (IV infusion) on Day 1 of each 14-day cycle, leucovorin at 200 mg/m2 (400 mg/m2 if using d,l-racemic mixture of leucovorin) by IV infusion on Day 1 of each cycle, and 5-FU at 400 mg/m2 as an IV bolus injection followed by a total of 2400 mg/m2 by continuous IV infusion over 46 hours over Days 1 and 2 via an ambulatory programmable pump (the use of an ambulatory pump is optional)."},{"intervention_type":"Drug","name":"Drug: E7820","description":"Test product: dose and mode of administration:\r\nE7820 is administered orally in tablet form once daily, every day of each 14-day treatment cycle. For the Phase Ib portion, the doses will be 40 mg/day, 70 mg/day, and 100 mg/day, and for the Pase II portion, the dose will be the MTD in combination with Irinotecan, as determined during the Phase ib portion of the study.\r\nThe irinotecan regimen consists of an irinotecan dose of 180 mg/m2 by IV infusion once every 2 weeks (Day 1 of each 14-day cycle)."}],"outcomes":[{"outcome_type":"primary","measure":"Safety parameter: adverse events","time_frame":"Participants will be followed for the duration of the study, an expected average of 18 months","description":"Phase Ib: to determine the maximum tolerated dose (MTD) of E7820 recommended for Phase II when administered in combination with Irinotecan in patients with locally advanced or metastatic colorectal cancer (mCRC) who have failed first-line therapy;\r\nPhase II: to evaluate the safety and tolerability of E7820 administered in combination with Irinotecan compared with FOLFIRI alone, in patients with locally advanced or metastatic colorectal cancer (mCRC)who have failed first-line therapy."},{"outcome_type":"primary","measure":"Safety Parameter: Concomitant medications","time_frame":"Participants will be followed for the duration of the study, an expected average of 18 months","description":"Phase Ib: to determine the maximum tolerated dose (MTD) of E7820 recommended for Phase II when administered in combination with Irinotecan in patients with locally advanced or metastatic colorectal cancer (mCRC) who have failed first-line therapy;\r\nPhase II: to evaluate the safety and tolerability of E7820 administered in combination with Irinotecan, compared with FOLFIRI alone, in patients with locally advanced or mCRC who have failed first-line therapy."},{"outcome_type":"primary","measure":"Safety parameter: lab tests","time_frame":"Assessed at Day 1 of each treatment cycle for the duration of the study and after termination of drug administration, an expected average of 6 months","description":"Phase Ib: to determine the maximum tolerated dose (MTD) of E7820 recommended for Phase II when administered in combination with Irinotecan in patients with locally advanced or metastatic colorectal cancer (mCRC) who have failed first-line therapy;\r\nPhase II: to evaluate the safety and tolerability of E7820 administered in combination with Irinotecan, compared with FOLFIRI alone, in patients with locally advanced or mCRC who have failed first-line therapy."},{"outcome_type":"primary","measure":"Safety parameter: ECGs","time_frame":"Assessed at Day 1 of each treatment cycle after termination of drug administration, an expected average of 3 years","description":"Description: Phase Ib: to determine the maximum tolerated dose (MTD) of E7820 recommended for Phase II when administered in combination with Irinotecan in patients with locally advanced or metastatic colorectal cancer (mCRC) who have failed first-line therapy;\r\nPhase II: to evaluate the safety and tolerability of E7820 administered in combination with Irinotecan, compared with FOLFIRI alone, in patients with locally advanced or mCRC who have failed first-line therapy."},{"outcome_type":"secondary","measure":"Efficacy parameter: Time to progression (TTP)","time_frame":"Assessed until disease progression or death, an expected average of 18 months","description":"Phase Ib: to determine the maximum tolerated dose (MTD) of E7820 recommended for Phase II when administered in combination with Irinotecan in patients with locally advanced or metastatic colorectal cancer (mCRC) who have failed first-line therapy;\r\nPhase II: to evaluate the safety and tolerability of E7820 administered in combination with Irinotecan, compared with FOLFIRI alone, in patients with locally advanced or metastatic colorectal cancer(mCRC) who have failed first-line therapy."},{"outcome_type":"secondary","measure":"Efficacy parameter: Overall survival (OS","time_frame":"Assessed until disease progression or death, an expected average of 3 years","description":"Phase Ib: to determine the maximum tolerated dose (MTD) of E7820 recommended for Phase II when administered in combination with the FOLFIRI regimen (irinotecan, leucovorin, and 5-fluorouracil [5-FU]) in patients with locally advanced or metastatic colorectal cancer (mCRC) who have failed first-line therapy;\r\nPhase II: to evaluate the safety and tolerability of E7820 administered in combination with the FOLFIRI regimen, compared with FOLFIRI alone, in patients with locally advanced or mCRC who have failed first-line therapy."},{"outcome_type":"secondary","measure":"Efficacy parameter: Overall response rate (ORR)","time_frame":"Assessed until disease progression or death, an expected average of 18 months","description":"Phase Ib: to determine the maximum tolerated dose (MTD) of E7820 recommended for Phase II when administered in combination with Irinotecan in patients with locally advanced or metastatic colorectal cancer (mCRC) who have failed first-line therapy;\r\nPhase II: to evaluate the safety and tolerability of E7820 administered in combination with Irinotecan, compared with FOLFIRI alone, in patients with locally advanced or metastatic colorectal cancer (mCRC) who have failed first-line therapy."}]}
{"nct_id":"NCT01655615","start_date":"2011-09-30","phase":"N/A","enrollment":31,"brief_title":"Does Delaying Adolescent Substance Use Lead to Improved Cognitive Function and Reduce Risk for Addiction?","official_title":"Co-venture: A Cluster Randomized Trial Investigating the Effects of Selective Intervention on Adolescent Cognitive Development and Addiction","primary_completion_date":"2018-06-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2018-12-31","last_update":"2016-10-31","description":"The Preventure Program is the first and only school-based alcohol and drug prevention program that has been shown to prevent onset and growth in alcohol and substance misuse in British and Canadian youth. Unlike universal programs that tend to promote generic coping skills and balance normative attitudes around substance use, this selected personality-targeted approach is based on a psychosocial model and validated by Dr Patricia Conrod and targets four personality-specific motivational pathways to substance misuse: Hopelessness, Anxiety Sensitivity, Impulsivity and Sensation Seeking, each associated with different motives for substance use, drug use profiles and patterns of non-addictive psychopathology. As a primary goal of the Coventure project, the investigators propose a long-term trial of this intervention strategy to examine how this evidence-based intervention can reduce onset of substance use disorders in young people and related secondary mental health, academic and cognitive outcomes. As a secondary goal, the investigators propose to use sensitive neuropsychological measures to examine how this evidence-based intervention can positively impact on cognitive development over the course of adolescence, to tease apart some of the mechanisms involved in the causal pathway from early onset substance use to poor cognitive development and long-term addiction outcomes.","other_id":"3427","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":12,"maximum_age":17,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Public or private high school\r\n\r\n          -  Must have a Grade 7 cohort of at least 100 youth (up to 200), providing access to\r\n             45-90 high risk students per school Selection of high risk youth: Inclusion criteria\r\n             for students are that they be enrolled in Grade 7 and that they have provided active\r\n             assent and passive parental consent to participate in the longitudinal survey and\r\n             randomised trial phases of this study. Participants who score 1 standard deviation\r\n             above the school mean on one of four subscales of the Substance Use Risk Profile Scale\r\n             will be selected to participate in the intervention groups, but all students will be\r\n             followed on outcomes. There are no other exclusion criteria for participants.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Schools cannot be classified as having a majority of their students coded as special\r\n             needs students, because these schools are smaller and the intervention protocol would\r\n             have to be tailored for their particular needs\r\n      ","sponsor":"St. Justine's Hospital","sponsor_type":"Other","conditions":"Alcohol Related Disorders|Substance Related Disorders","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Preventure programme","description":"The interventions are conducted using manuals which incorporate psycho-educational, motivational enhancement therapy and cognitive-behavioural (CBT) components, and include real life 'scenarios' shared by local youth in with similar personality profiles. In the first session, participants are guided in a goal-setting exercise, designed to enhance motivation to change behaviour. Psycho-educational strategies are then used to teach participants about the target personality variable and associated problematic coping behaviours like avoidance, interpersonal dependence, aggression, risky behaviours and substance misuse."}],"outcomes":[{"outcome_type":"primary","measure":"Dep Ado: onset, frequency and binge items","time_frame":"Years 1, 2, 3,4 and 5","description":"The 'Detection of alcohol and drug problems in adolescents' questionnaire (DEP-ADO) is a self-report alcohol and illicit drug use measure in high-risk youth, including onset of drinking, binge drinking and illicit drug use. This tool has demonstrated good construct validity, internal consistency, test-retest and intermodal execution reliability in Quebec youth."},{"outcome_type":"secondary","measure":"Global cognitive function","time_frame":"Years 1, 2, 3,4 and 5","description":"1. A computerised adaptation of the Cultures Figure Task (CFT) is used to measure fluid intelligence. This task is based on two of the sections from Cattell's Culture Fair Intelligence Test: the linear pattern completion and matrix reasoning.\r\nii. A computerised task based on the 'Dot Location' test, a subtest of the Child Memory Scales (CMS) is used to assess spatial memory. In this task, eight dots of the same colour are presented on a grid."},{"outcome_type":"secondary","measure":"Executive function","time_frame":"Years 1, 2, 3,4 and 5","description":"Two tasks are used to assess executive functioning. i. 'Find the phone' is a spatial working memory task based on the Self-Order Pointing Task and is similar to the spatial working memory task of the Cambridge Neuropsychological Test Automated Battery (CANTAB).\r\nii. An adaptation of the Go/No-Go Passive Avoidance Learning Paradigm (PALP) is used to assess cognitive control and response inhibition."},{"outcome_type":"secondary","measure":"Functional cognitive measures","time_frame":"Years 1, 2, 3,4 and 5","description":"Data regarding academic achievement and school drop-out will be collected from the school administration."},{"outcome_type":"secondary","measure":"Mental disorder symptoms","time_frame":"Years 1, 2, 3,4 and 5","description":"Depression and anxiety symptom severity over the past 12 months are measured using the Depression and Anxiety subscales from the Brief Symptoms Inventory. Conduct problems and hyperactivity/inattentive symptoms over the past 12 months are assessed according to the conduct and hyperactivity/inattentive subscales of the Strengths and Difficulties Questionnaire."}]}
{"nct_id":"NCT01362855","start_date":"2011-09-30","enrollment":503,"brief_title":"Advance Care Planning Evaluation in Hospitalized Elderly Patients","official_title":"Advance Care Planning Evaluation in Hospitalized Elderly Patients: A Multicenter, Prospective Study","primary_completion_date":"2015-03-31","study_type":"Observational","rec_status":"Completed","completion_date":"2015-05-31","last_update":"2020-12-16","description":"The purpose of the study is to inform decision-makers of the best strategies to implement advanced care planning (ACP). An advanced care plan (ACP) is a verbal or written instruction describing what kind of care an individual would want (or not want)if they are no longer able speak for themselves to make health care decisions.","other_id":"ACCEPT Study","observational_model":"Other","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":55,"population":"We will enroll patients who are at high risk of dying and/or their families (where\r\n        available).","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  55 years or older with one or more of the following diagnoses:\r\n\r\n               -  Chronic obstructive lung disease - 2 of the 4 of: baseline PaCO2 of > 45 torr,\r\n                  cor pulmonale; respiratory failure episode within the preceding year; forced\r\n                  expiratory volume in 1 sec <0.5 L.\r\n\r\n               -  Congestive heart failure - New York Heart Association class IV symptoms and left\r\n                  ventricular ejection fraction < 25%.\r\n\r\n               -  Cirrhosis - confirmed by imaging studies or documentation of esophageal varices\r\n                  and one of three conditions: a) hepatic coma, b) Child's class C liver disease,\r\n                  or c) Child's class B liver disease with gastrointestinal bleeding.\r\n\r\n               -  Cancer - metastatic cancer or stage IV lymphoma.\r\n\r\n               -  End-stage dementia (inability to perform all ADLs, mutism or minimal verbal\r\n                  output secondary to dementia, bed-bound state prior to acute illness) OR\r\n\r\n          -  Any patient 80 years of age or older admitted to hospital from the community because\r\n             of an acute medical or surgical condition.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Non-English speaking patient/family member\r\n\r\n          -  Patient with cognitive impairment\r\n      ","sponsor":"Daren K. Heyland","sponsor_type":"Other","conditions":"Critical Illness|Chronic Obstructive Lung Disease|Congestive Heart Failure|Cirrhosis|Cancer","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Extent of Implementation of ACP","time_frame":"Year 3","description":"a. Does the patient have an advance directive or living will or some other written document expressing their wishes? b.patient and/or family been informed of the patients' prognosis? c.Has the patient and/or family been informed about the expected benefits and burdens of various treatment options? d.Has the patient considered how s/he wants to live in the final stages of life and what kinds of medical treatments they would want or not want? e.Have they discussed this with their family? A health care provider? g.Has there been a discussion about their goals of care with their health care provider? If so, are they aware of them? h.Has there been a decision made about medical treatments at the end of life? If so, what role did the patient/family play in that decision-making and was this consistent with their preferred role? i.Is there documentation in the medical record of the overall goals of care?"},{"outcome_type":"secondary","measure":"Effect of an audit and feedback process plus tailored interventions ACP","time_frame":"Year 3","description":"Compared to baseline, what is the effect of an audit and feedback process coupled with tailored interventions on use of and satisfaction with ACP at the site level?"},{"outcome_type":"secondary","measure":"Impact of ACP on patient/family satisfaction","time_frame":"Year 3","description":"Compared to those patients who have not undergone an ACP process upon enrolment, what is the impact of ACP on patient/family satisfaction with care, use of life-sustaining technologies, and hospital resources during index hospital admission and long-term health care utilization?"},{"outcome_type":"secondary","measure":"ACP components associated with overall satisfaction","time_frame":"Year 3","description":"Which components of ACP are more strongly associated with overall satisfaction with EOL communication and decision making?"},{"outcome_type":"secondary","measure":"Comparison of sites with low vs high system level implementation of ACP on satisfaction","time_frame":"Year 3","description":"At baseline, compared to sites with low degrees of system level implementation, do sites with higher levels of system level integration have a higher prevalence of ACP and greater satisfaction with EOL communication and decision-making?"}]}
{"nct_id":"NCT02084641","start_date":"2011-09-30","phase":"N/A","enrollment":45,"brief_title":"Adipose Tissue Response to Overfeeding in Insulin Resistance-Prone vs. Insulin Sensitive Humans","official_title":"Adipose Tissue Response to Overfeeding in Insulin Resistance-Prone vs. Insulin Sensitive Humans","primary_completion_date":"2016-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2016-12-31","last_update":"2014-03-12","description":"Obesity has become an epidemic worldwide. Data from our laboratory and others demonstrate that most of the excess morbidity from obesity is related to insulin resistance (IR). While total adiposity correlates with insulin resistance, not all obese individuals are IR. When obese IR individuals lose weight in response to caloric restriction, even moderate loss of body fat results in improved insulin sensitivity (IS). With massive weight loss, either dietary or surgical, even the most IR individuals can completely reverse their insulin resistance. But why is one individual IR at a BMI of 26 and another IS at a BMI of 35? There must be differences in the manner in which adipose cells/tissue respond to caloric excess and weight gain. One potentially unifying hypothesis with regard to obesity-associated insulin resistance is that those individuals who fail to respond to caloric excess/obesity with adequate adipocyte differentiation and expanded subcutaneous fat storage capacity develop increased circulating FFAs, ectopic fat deposition, stress on adipocytes, triggering localized and systemic inflammation and ultimately insulin resistance in skeletal muscle. Clearly, the best way to examine the human response to obesity is to challenge overweight individuals with the need to store excess triglyceride in adipose tissue. Specific aims are: 1. Test the hypothesis that impaired adipogenesis and fat storage capacity are associated with insulin resistance by comparing 1) cell size distribution; 2) gene markers of adipose cell differentiation; 3) differentiation of isolated preadipocytes in IR-prone vs IS individuals subjected to caloric excess. 2. Determine if circulating (daylong FFA, two-stage Insulin Suppression Test) and ectopic fat (MRI liver, CT abdomen) are worsened to a greater degree in IR-prone vs IS individuals subjected to caloric excess. 3. Determine whether differences in inflammation and/or innate or adaptive immune response are associated with insulin resistance by comparing differences in resident dendritic cells, macrophages and their activation profiles, changes in T-cell subpopulations, and other inflammatory mediators in IR-prone vs IS individuals who are subjected to caloric excess via overfeeding. 4. Exploratory: Evaluate IR-prone vs IS individuals for evidence of hypoxia and insufficient angiogenic response in response to caloric excess.","other_id":"20281","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":35,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        BMI 25-35 kg/m2 Healthy adults Age 35-65 Weight stable Nondiabetic\r\n\r\n        Exclusion Criteria:\r\n\r\n        Major organ disease such as heart, kidney, liver Malignancy Inflammatory conditions (eg.\r\n        lupus, rheumatoid arthritis, Crohn's disease) Eating disorder h/o bariatric surgery or\r\n        liposuction use of blood thinners such as Coumadin (aspirin is ok)\r\n      ","sponsor":"Stanford University","sponsor_type":"Other","conditions":"Insulin Resistance|Obesity","interventions":[{"intervention_type":"Other","name":"Other: Over feeding","description":"Study participants will be given low saturated fat snacks, an additional 750-1000 calories to gain 6-8 lbs over 4 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Subcutaneous adipose cell triglyceride storage capacity/differentiation","time_frame":"3 years","description":"this will be quantified by measuring: 1) adipose cell size distribution; 2) gene markers of adipose cell differentiation; 3) differentiation of isolated preadipocytes in IR-prone vs IS individuals subjected to caloric excess; in vivo triglyceride synthesis using stable isotope methods"},{"outcome_type":"secondary","measure":"Ectopic fat","time_frame":"3 years","description":"Fat deposited in liver (MRI), visceral (intraabdominal) abdominal (CT) versus subcutaneous abdominal and thigh fat (CT)"},{"outcome_type":"other","measure":"Adipose tissue and systemic inflammation: both innate or adaptive immune response","time_frame":"3 years","description":"Flow cytometry will be used to quantitate, in both adipose tissue and plasma, populations of dendritic cells, T-cell subpopulations, and macrophages"}]}
{"nct_id":"NCT01430845","start_date":"2011-09-01","enrollment":150,"brief_title":"Predicting Developmental Disability Type and Mental Retardation Level in Children With General Developmental Delay","official_title":"Predicting Developmental Disability Type and Mental Retardation Level in Children Who Were Diagnosed in General Developmental Delay","primary_completion_date":"2015-12-01","study_type":"Observational","rec_status":"Completed","completion_date":"2015-12-01","last_update":"2018-06-29","description":"The purpose of this study is to find the relationship between the stage and quality of developmental delay during infancy and toddler age, and the final diagnosis that the child gets a few years later (MR, type of PDD, CP or comorbidity of a few disorders).","other_id":"SHEBA-11-8458-LG-CTIL","observational_model":"Case-Only","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","population":"The study will be conducted at the Child Development Center in Tel-Hashomer hospital\r\n        (Ramat-Gan, Israel). The target population is all children who were diagnosed at the\r\n        hospital with GDD (in two axis' at least) between the years 2003 to 2005. They must also\r\n        have undergone the BSID test in its second or third version. The data must be available on\r\n        all assessments (N~150). The children were 1.5-3 years old at diagnosis and diagnosed by a\r\n        doctor and psychologist. Today these children are 5-7 years old. Some of them are still\r\n        being treated in Tel-Hashomer. The children live all over the country","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  GDD diagnosis in two axis' at least\r\n\r\n          -  BSID test in its second or third version\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  If not all of the data is available for all of the assessments\r\n      ","sponsor":"Sheba Medical Center","sponsor_type":"Other","conditions":"Global Developmental Delay|Cerebral Palsy|Mental Retardation|Pervasive Developmental Disorders","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"level of Mental retardation in older age","time_frame":"non"}]}
{"nct_id":"NCT01404403","start_date":"2011-08-31","phase":"Phase 1","enrollment":12,"brief_title":"Safety Study of the Rapid System for Acute Ischemic Stroke","primary_completion_date":"2013-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-10-31","last_update":"2013-11-05","description":"This is a safety study of the Rapid System for acute ischemic stroke.","other_id":"002-07-01-RR","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients 18 to <85 years old\r\n\r\n          -  Pre stroke modified Rankin Scale (mRS) of 2\r\n\r\n          -  A signed informed consent by patient or a legally acceptable representative\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pre-stroke life expectancy of less than 6 months\r\n\r\n          -  Current participation in another investigational drug or device study\r\n\r\n          -  Pregnancy\r\n      ","sponsor":"Rapid Medical","sponsor_type":"Industry","conditions":"Acute Ischemic Stroke","interventions":[{"intervention_type":"Device","name":"Device: Rapid System"}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of participants with Adverse Device Effects (ADEs) Percentage of participants with Adverse Device Effects (ADEs)Percentage","time_frame":"12 patients"}]}
{"nct_id":"NCT01518998","start_date":"2011-08-31","phase":"Phase 2","enrollment":420,"brief_title":"A Randomized, Double-Blind, Placebo-Controlled, 3x3 Factorial Design, Phase II Study to Evaluate the Antihypertensive Efficacy and Safety of Combination of Fimasartan and Amlodipine in Patients With Essential Hypertension","primary_completion_date":"2013-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-11-30","last_update":"2016-07-01","description":"The purpose of this study is to evaluate the antihypertensive efficacy and safety of Fimasartan","other_id":"BR-FAC-CT-201","allocation":"Randomized","intervention_model":"Factorial Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Subjects who agreed to participate in this study and submitted the written informed\r\n             consent\r\n\r\n          2. Subjects aged 20 to 75 years\r\n\r\n          3. Essential hypertension subjects who are measured more 90mmHg, less than 114mmHg of\r\n             sitting diastolic blood pressure (SiDBP) at baseline(day 0).\r\n\r\n          4. Subjects who considered to understand this study , be cooperative, and able to be\r\n             followed-up whole of the study period.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Severe hypertension patients; more 115mmHg of SiDBP and/or more 185 mmHg of Sitting\r\n             systolic blood pressure (SiSBP)\r\n\r\n          2. Patients with secondary hypertension\r\n\r\n          3. Patients with significant investigations - abnormal renal function (Creatinine more\r\n             1.5 times than upper limit of normal), abnormal liver function (AST, ALT more 2 times\r\n             than upper normal), moderate fatty lever needed medication\r\n\r\n          4. Patients with significant investigations - Hypokalemia(Less than 3.5mmol/L),\r\n             Hyperkalemia(exceeded 5.5mmol/L)\r\n\r\n          5. Patients with sodium ion or body fluid is depleted and not able to correct\r\n\r\n          6. Patients with hypotension who has sign and symptom\r\n\r\n          7. Patients with surgical and medical disease it is able to be affect to absorption,\r\n             distribution, metabolism, excretion\r\n\r\n          8. Patients with severe insulin dependent or uncontrolled diabetes mellitus (HbA1c > 9%,\r\n             regimen change of oral hypoglycemic agent, using insulin)\r\n\r\n          9. Patients with severe heart disease, ischemic heart disease within 6months, peripheral\r\n             vascular disease, Percutaneous Transluminal Coronary Angiography (PTCA), Coronary\r\n             Artery Bypass Graft (CABG)\r\n\r\n         10. Patients with significant ventricular tachycardia, atrial fibrillation, atrial flutter\r\n             or other significant arrhythmia\r\n\r\n         11. Patients with hypertrophic obstructive cardiomyopathy, severe obstructive coronary\r\n             artery disease, aortic stenosis, hemodynamically significant aortic valve or mitral\r\n             valve disease\r\n\r\n         12. Patients with severe cerebrovascular disease\r\n\r\n         13. Patients with wasting disease, autoimmune disease, connective tissue disease at\r\n             present and/or previous.\r\n\r\n         14. Patients with known severe or malignancy retinopathy\r\n\r\n         15. Patients with hepatitis B or C or HIV positive reaction\r\n\r\n         16. Patients who have a story or evidence of alcohol or drug abuse within 2years\r\n\r\n         17. Patients who are measured the mean difference of mean blood pressure of both arm under\r\n             SiDBP 10mmHg or SiSBP 20mmHg at screening and baseline visit\r\n\r\n         18. Patients with history of allergic reaction to any angiotensin II antagonist\r\n\r\n         19. Patients with any chronic inflammation disease needed to chronic inflammation therapy\r\n\r\n         20. Patients with the medical histories of malignant tumor within 5years, except local\r\n             basal cell carcinoma of the skin\r\n\r\n         21. Childbearing and breast-feeding women\r\n\r\n         22. Female who plan to become pregnancy or have a possibility of pregnancy but don't\r\n             prevent conception with acknowledged methods\r\n\r\n         23. Patients who took medicine within 12 weeks from screening visit or is going on the\r\n             progress of other clinical trial\r\n\r\n         24. Subject who are judged unsuitable to participate in this study by investigator\r\n      ","sponsor":"Boryung Pharmaceutical Co., Ltd","sponsor_type":"Industry","conditions":"Hypertension","interventions":[{"intervention_type":"Drug","name":"Drug: Fimasartan , Amlodipine, Placebo","description":"Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60mg/Amlodipine 5mg combination, Fimasartan 60mg/Amlodipine 10mg combination, Fimasartan 30mg/Amlodipine 5mg combination, Fimasartan 30mg/Amlodipine 10mg combination"}],"outcomes":[{"outcome_type":"primary","measure":"Sitting Diastolic Blood Pressure","time_frame":"8weeks from baseline visit","description":"To compare the difference of Sitting Diastolic Blood Pressure at 8 weeks from baseline visit"},{"outcome_type":"secondary","measure":"Sitting Systolic Blood Pressure","time_frame":"at 4 and 8 weeks from Baseline visit","description":"To compare the difference of Sitting Systolic Blood Pressure at 4,8 weeks from baseline visit"},{"outcome_type":"secondary","measure":"Sitting Diastolic Blood Pressure","time_frame":"4weeks from baseline visit","description":"To compare the difference of Sitting Diastolic Blood Pressure at 4 weeks from baseline visit"},{"outcome_type":"secondary","measure":"Responder ratio","time_frame":"at 8weeks from baseline visit","description":"To compare the ratio or responder(SiDBP<90mmHg or difference of SiDBP>10mmHg from baseline) at 8 weeks"}]}
{"nct_id":"NCT01425528","start_date":"2011-08-31","phase":"Phase 1/Phase 2","enrollment":12,"brief_title":"Study of Kuvan Treatment in Adults With GTPCH Deficiency","official_title":"Pilot Study to Assess Impact of Kuvan Supplementation as an Adjunct Treatment in Subjects With Dominantly-inherited GTPCH Deficiency on Mood, Behavioral and Motor Phenotypes","primary_completion_date":"2013-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-08-31","last_update":"2014-04-08","description":"The purpose of this study is to identify the dose of Kuvan needed to normalize the levels of tetrahydrobiopterin (BH4) in patients with a Guanosine Triphosphate Cyclohydrolase (GTPCH) deficiency and to asses the potential impact of oral Kuvan on mood and function in individuals with GTPCH deficiency who may be experiencing symptoms of anxiety, depression, fatigue, trouble concentrating, or memory loss. This will be a phase one study. The investigators will monitor patients over a period of three to six months while on the medication. Medication levels will be monitored by measuring the BH4 levels in cerebral spinal fluid (CSF). Patients will undergo a baseline lumbar puncture and two follow-up lumbar punctures for this purpose. The investigators will also monitor emotional function and motor function.","other_id":"48052","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  established diagnosis of GTPCH deficiency, supported by appropriate family history,\r\n             CSF neurotransmitter studies, skin fibroblast enzyme assay and/or mutation analysis\r\n\r\n          -  minimum age 18 years\r\n\r\n          -  identified by self or others to have symptoms of anxiety, depression, fatigue, or\r\n             other neurocognitive dysfunction (trouble concentrating, memory loss, etc)\r\n\r\n          -  willingness to undergo at least 2 CSF evaluations for BH4 and neurotransmitter levels\r\n             over an 8 to 12 week period\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  age < 18 years old\r\n\r\n          -  unwillingness to undergo repeated CSF analysis\r\n\r\n          -  lack of supporting diagnostic criteria\r\n\r\n          -  concomitant medical problems or medications which would increase risk of Kuvan\r\n\r\n          -  concomitant psychiatric state, such as severe depression with suicidal ideation that\r\n             requires immediate referral and alternative treatment intervention\r\n\r\n          -  prior history of back surgery, abnormality or chronic pain that in the opinion of the\r\n             investigator would increase risks associated with lumbar puncture\r\n\r\n          -  significant obesity that might increase difficulty or risk in performing lumbar\r\n             puncture\r\n\r\n          -  if female, unwillingness to use birth control during the period of study drug\r\n             administration\r\n      ","sponsor":"University of Utah","sponsor_type":"Other","conditions":"GTP Cyclohydrolase Deficiency","interventions":[{"intervention_type":"Drug","name":"Drug: Sapropterin","description":"Sapropterin will be taken daily for 12 or 24 weeks. Starting dose will be 20mg/kg/day and will increase at the 8 week visit to 30 mg/kg/day. Dosing may be further increased to as high as 40 mg/kg/day in attempt to normalize BH4 levels in CSF. Starting dose for Cohort 2 will be determined from data analysis in Cohort 1."}],"outcomes":[{"outcome_type":"secondary","measure":"Hamilton Depression Rating Scale","time_frame":"Baseline, 8 wks, 12 wks, 24 wks (optional)"},{"outcome_type":"primary","measure":"Change in BH4 Levels in Cerebral Spinal Fluid","time_frame":"Baseline, 8 wks, 12 wks","description":"Identify dosing range of oral Kuvan® necessary and sufficient to normalize CSF BH4 levels in adults with GTPCH Deficiency."},{"outcome_type":"primary","measure":"Change in Neurotransmitter Metabolite Levels in Cerebral Spinal Fluid","time_frame":"Baseline, 8 wks, 12 wks"},{"outcome_type":"secondary","measure":"Hamilton Anxiety Rating Scale","time_frame":"Baseline, 8 wks, 12 wks, 24 wks (optional)"},{"outcome_type":"secondary","measure":"Behavior Rating Inventory of Executive Function (BRIEF) Adult Version","time_frame":"Baseline, 8 wks, 12 wks, 24 wks (optional)"},{"outcome_type":"secondary","measure":"Beck Depression Inventory","time_frame":"Baseline, 8 wks, 12 wks, 24 wks (optional)"},{"outcome_type":"secondary","measure":"Brief Symptom Inventory","time_frame":"Baseline, 8 wks, 12 wks, 24 wks (optional)"},{"outcome_type":"secondary","measure":"Pittsburgh Sleep Quality Index","time_frame":"Baseline, 8 wks, 12 wks, 24 wks (optional)"}]}
{"nct_id":"NCT01473706","start_date":"2011-08-31","enrollment":463,"brief_title":"Validation of a Nutrition Screening Tool","official_title":"Mini Nutritional Assessment: Consumer Validation","primary_completion_date":"2012-01-31","study_type":"Observational","rec_status":"Completed","completion_date":"2012-06-30","last_update":"2013-07-17","description":"The purpose of this study is to compare the accuracy of a new consumer nutrition screening tool to an established and validated nutrition screening tool currently completed by healthcare practitioners.","other_id":"11.01.US.HCN","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":65,"population":"Consumers aged 65 or older with or without their caregiver","criteria":"\n        Inclusion Criteria:\r\n\r\n        - Consumer\r\n\r\n          -  Age  65 years\r\n\r\n          -  Employed part-time, unemployed, retired, full-time homemaker\r\n\r\n          -  English speaking\r\n\r\n             - Caregiver of Consumer\r\n\r\n          -  Family, relative, friend, professional caregiver of an individual age  65 years\r\n\r\n          -  Lives with individual aged  65 years OR Visits individual aged  65 years five or\r\n             more days a week\r\n\r\n               -  Makes decisions or has strong influence on the individual aged  65 years' diet\r\n                  and medical needs.\r\n\r\n          -  English speaking\r\n\r\n        Exclusion Criteria:\r\n\r\n        - Consumer\r\n\r\n        -- Full time employment\r\n      ","sponsor":"Nestl","sponsor_type":"Industry","conditions":"Malnutrition","interventions":[{"intervention_type":"Other","name":"Other: Consumer Mini Nutritional Assessment","description":"A 11 question, self administered nutrition screening tool. The consumer and their caregiver will complete the consumer version of the Mini Nutritional Assessment. A healthcare professional will then meet with the consumer and complete a nutrition screening with utilizing a validated nutrition screening tool."}],"outcomes":[{"outcome_type":"primary","measure":"Sensitivity and the specificity (in percent) of the consumer version of the Mini Nutritional Assessment versus a validated nutrition screening tool","time_frame":"Within a one hour visit"},{"outcome_type":"secondary","measure":"Ability of the consumer version of the Mini Nutritional Assessment to predict the accuracy of the nutrition status classifications (normal nutritional status, at risk of malnutrition & malnourished)","time_frame":"Within a one hour visit"}]}
{"nct_id":"NCT01582620","start_date":"2011-08-31","phase":"N/A","enrollment":50,"brief_title":"Telestroke in Nordland Hospital. A Study of a Telemedicine Network in Rural Hospitals","official_title":"Telestroke in Nordland Hospital: Improved Treatment of Cerebral Stroke in Small Hospitals","primary_completion_date":"2012-12-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2020-03-24","last_update":"2020-03-26","description":"The purpose is to study the clinical, technological and organizational impacts of a telestroke service between Nordlandssykehuset, Bod, and two small rural hospitals in Lofoten and Vesterlen. The stroke specialist in Bod will examine the patient in cooperation with the doctor at the local hospital through video- and sound communication. Radiology images are transmitted using the RIS/PACS system. Telestroke consultations may be useful to assess whether the patient needs thrombolysis medication, and also whether there is a need for more advanced specialist neurological or neurosurgical treatment, supporting quick triaging and transfer to the appropriate unit. The study design is a multi-method approach using before-and-after hospital information data as well as registration forms monitoring patient outcome and pathways. The research questions will be approached from medical, organisational and technological perspectives. A telestroke service in North Norway is expected to face other challenges than those reported internationally: In Nordlandssykehuset, as in Helse Nord in general, the number of cases is low, clinicians have high turnover, technical support is not available 24/7 and severe weather conditions and long distances might add to the transport time. Primary hypothesis: The use of telestroke leads to faster and more accurate diagnosis and proper treatment Secondary hypothesis: Telestroke leads to improved overall patient treatment","other_id":"2010/2277(REK)","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Health Services Research","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients admitted to the two local hospitals diagnosed with acute cerebral stroke\r\n      ","sponsor":"University Hospital of North Norway","sponsor_type":"Other","conditions":"Stroke, Acute","interventions":[{"intervention_type":"Procedure","name":"Procedure: Telestroke","description":"remote videoconference consultations"}],"outcomes":[{"outcome_type":"primary","measure":"Change in the proportion of stroke patients receiving thrombolysis treatment after the introduction of a telestroke service","time_frame":"Approx. 30 months"},{"outcome_type":"secondary","measure":"Door-to-(thrombolysis)needle-time","time_frame":"18 months"},{"outcome_type":"secondary","measure":"Scores for functional outcomes at admission and discharge","time_frame":"18 months"},{"outcome_type":"secondary","measure":"Proportion of patient transfers from Lofoten and Vesterålen in the acute phase to secondary level","time_frame":"18 months"},{"outcome_type":"secondary","measure":"Proportion of stroke patients receiving \"telestroke\" examination","time_frame":"18 months"}]}
{"nct_id":"NCT01418768","start_date":"2011-08-31","phase":"N/A","enrollment":50,"brief_title":"Effects of an Inpatient Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease (COPD) III/IV","primary_completion_date":"2012-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-12-31","last_update":"2013-02-04","description":"The purpose of this study is to determine if there is a change in the CAT-score after an inpatient rehabilitation of three weeks and if it correlates with other common parameters.","other_id":"CAT2011","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  inpatient rehabilitation in Schn Klinik Berchtesgadener Land\r\n\r\n          -  stable COPD(GOLD severity III and IV with and without respiratory insufficiency)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  severe exacerbation in the last four weeks\r\n\r\n          -  acute coronary syndrome\r\n\r\n          -  unability to cooperate\r\n      ","sponsor":"Schn Klinik Berchtesgadener Land","sponsor_type":"Other","conditions":"Chronic Obstructive Pulmonary Disease","interventions":[{"intervention_type":"Other","name":"Other: inpatient rehabiliation","description":"inpatient, multimodal, individual workout including endurance training, strength training, coordination training etc. for three weeks."}],"outcomes":[{"outcome_type":"primary","measure":"Change in CAT-score","time_frame":"day 1 to day 21"},{"outcome_type":"secondary","measure":"Change in 6 minutes walking distance","time_frame":"day 1 to day 21"},{"outcome_type":"secondary","measure":"Change in Short-Form 36","time_frame":"day 1 to day 21"},{"outcome_type":"secondary","measure":"Change in Hospital Anxiety and Depression Scale","time_frame":"day 1 to day 21"},{"outcome_type":"secondary","measure":"Change in diffusing capacity","time_frame":"day 1 to day 21"},{"outcome_type":"secondary","measure":"Change in forced expiratory volume in 1 second (FEV1)","time_frame":"day 1 to day 21"},{"outcome_type":"secondary","measure":"Change in Body Mass index","time_frame":"day 1 to day 21"},{"outcome_type":"secondary","measure":"Change in basal energy rate","time_frame":"day 1 to day 21"},{"outcome_type":"secondary","measure":"Change in BODE-Index","time_frame":"day 1 to day 21"},{"outcome_type":"secondary","measure":"Change in St. George's Respiratory Questionaire","time_frame":"Day 1 to day 21"}]}
{"nct_id":"NCT00932048","start_date":"2011-08-31","phase":"N/A","enrollment":0,"brief_title":"Effect of Atorvastatin on Vascular Inflammation in Type 2 Diabetes","official_title":"Effect of Atorvastatin on Vascular Inflammation in Type 2 Diabetes: Analysis With 18F-Fluorodeoxyglucose Positron Emission Tomography","primary_completion_date":"2012-01-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2012-03-31","last_update":"2013-09-06","description":"Type 2 diabetes mellitus significantly increases the risk for the development of atherosclerosis. Recently, atherosclerosis imaging with 18F-FDG PET (18F-Fluorodeoxyglucose Positron Emission Tomography) is useful for tracking inflammation within plaque and monitoring the response to drug therapy The purpose of this study is to determine whether FDG-PET is capable of detecting atherosclerotic vascular inflammation and monitoring the early effects of statins in type 2 diabetic patients. The usefulness of FDG-PET in risk stratification is also investigated.","other_id":"R0709211","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":35,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Type 2 diabetic patients who are aged 35 to 80 year-old\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Insulin use\r\n\r\n          -  Patients who receive any dyslipidaemia under medications (including statins) in recent\r\n             one year\r\n\r\n          -  Women of child-bearing potential are excluded (i.e. menopausal women or\r\n             post-hysterectomy women are included in this study) due to radiation exposure in this\r\n             study\r\n\r\n          -  Active inflammatory diseases\r\n\r\n          -  Vasculitis, symptomatic coronary artery disease, symptomatic cerebrovascular diseases\r\n\r\n          -  Significant concomitant disease such as active infection, malignancy, hepatic or renal\r\n             dysfunction at the time of enrollment (i.e. T-Bil > 3 mg/dlALT > 2.5 times the upper\r\n             limit of normal range and Creatinine > 2 mg/dl in our hospital)\r\n      ","sponsor":"Korea University","sponsor_type":"Other","conditions":"Type 2 Diabetes|Atherosclerosis","interventions":[{"intervention_type":"Drug","name":"Drug: Atorvastatin","description":"Atorvastatin 10mg once daily for 12 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Vascular inflammation analyzed by PET: Define attenuation of plaque inflammation (plaque SUV or TBR) at 12 weeks","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"Change in LDL-cholesterol levels after active treatment","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"Biomarkers: hs-CRP, adiponectin, MCP-1, PAI-1, TNF-α, IL-6","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"Change in carotid plaque thickness by ultrasound","time_frame":"12 weeks"}]}
{"nct_id":"NCT01405911","start_date":"2011-08-16","phase":"Phase 2","enrollment":242,"brief_title":"Dose Response Finding Study of MK-0431/ONO-5435 in Japanese Subjects With Impaired Glucose Tolerance (MK-0431-105)","official_title":"A Phase II, Randomized, Placebo-Controlled, Parallel-group, Double-Blind, Dose Response Finding Clinical Trial to Study the Efficacy and Safety of MK-0431/ONO-5435 in Japanese Subjects With Impaired Glucose Tolerance Who Have Inadequate Glycemic Control on Diet/Exercise Therapy","primary_completion_date":"2012-04-09","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-04-09","last_update":"2020-01-18","description":"This study is being done to evaluate the safety, efficacy, and dose level of sitagliptin (MK-0431/ONO-5435) used once daily (qd) in Japanese participants with impaired glucose tolerance who have inadequate glycemic control using diet and exercise therapy.","other_id":"0431-105","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":20,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Impaired glucose tolerance\r\n\r\n          -  On diet/exercise therapy\r\n\r\n          -  Unlikely to conceive\r\n\r\n          -  Meets all of the following glycemic parameters: Hemoglobin A1c (Japan Diabetes Society\r\n             value) <6.1%, Fasting Plasma Glucose <126 mg/dL, and 2-hr plasma glucose level in 75g\r\n             oral glucose tolerance test 140 mg/dL and <200 mg/dL\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of diabetes mellitus\r\n\r\n          -  Disease or condition of clear or likely glucose tolerance disorder\r\n\r\n          -  Previously treated with a drug to prevent diabetes and/or any antihyperglycemic drug\r\n      ","sponsor":"Merck Sharp & Dohme Corp.","sponsor_type":"Industry","conditions":"Glucose Intolerance","interventions":[{"intervention_type":"Drug","name":"Drug: Placebo for Sitagliptin 25 mg","description":"1 tablet orally once daily before breakfast for 8 weeks"},{"intervention_type":"Drug","name":"Drug: Placebo for Sitagliptin 50 mg","description":"1 tablet orally once daily before breakfast for 8 weeks"},{"intervention_type":"Drug","name":"Drug: Sitagliptin 25 mg","description":"1 tablet orally once daily before breakfast for 8 weeks"},{"intervention_type":"Drug","name":"Drug: Sitagliptin 50 mg","description":"1 tablet orally once daily before breakfast for 8 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of Participants Who Experienced One or More Adverse Events (AEs)","time_frame":"Up to 10 weeks","description":"An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product."},{"outcome_type":"primary","measure":"Percent Change From Baseline in Glucose Total Area Under the Concentration Curve 0 to 2 Hours (AUC 0-2 Hrs) for Meal Tolerance Test (MTT) at Week 8","time_frame":"Baseline (Week 0) and Week 8","description":"Glucose total AUC 0-2 hours for MTT was measured at Baseline (Week 0) and at Week 8. After fasting for ≥10 hours, blood samples for glucose measurement were drawn at 0 minutes (at standard meal loading), 30 minutes, 60 minutes, 90 minutes, and 120 minutes. At Week 8, participants received study drug or placebo 30 minutes prior to consuming a standard meal."},{"outcome_type":"primary","measure":"Percentage of Participants Who Discontinued Treatment Due to an Adverse Event (AE)","time_frame":"Up to 8 weeks","description":"An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product."},{"outcome_type":"secondary","measure":"Percent Change From Baseline in Glucose Total Area Under the Concentration Curve 0 to 2 Hours (AUC 0-2 Hrs) for 75-gram Oral Glucose Tolerance Test (OGTT) at Week 7","time_frame":"Baseline (Week -1) and Week 7","description":"Glucose total AUC 0-2 hours for 75 g OGTT was measured at Baseline (Week -1) and at Week 7. After fasting for ≥10 hours, blood samples for glucose measurement were drawn at 0 minutes (at 75 g glucose loading), 30 minutes, 60 minutes, 90 minutes, and 120 minutes. At Week 7, participants received study drug or placebo 30 minutes prior to loading 75 g glucose solution."}]}
{"nct_id":"NCT01397422","start_date":"2011-07-31","phase":"Phase 2/Phase 3","enrollment":83,"brief_title":"Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)","official_title":"Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)","primary_completion_date":"2013-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-10-31","last_update":"2017-12-13","description":"This is a multi-center, randomized, double-blind, placebo-controlled, 4-arm parallel group study to evaluate the tolerability and efficacy of each of three dose levels of ADS-5102 oral capsules, an extended release formulation of amantadine, dosed once daily for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel pharmacokinetic profile of ADS-5102 is expected to achieve i) higher amantadine plasma concentrations during daytime hours when dyskinesia as well as motor and non-motor symptoms of PD are most problematic, ii) low amantadine plasma concentrations overnight, which may reduce the sleep disturbances and vivid dreams occasionally associated with amantadine, and iii) a reduced initial rate of rise in plasma concentration, which is expected to improve overall tolerability of amantadine.","other_id":"ADS-PAR-AM201","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":30,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Signed a current IRB/IEC-approved informed consent form\r\n\r\n          -  Parkinson's disease, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical\r\n             Diagnostic Criteria\r\n\r\n          -  On a stable regimen of antiparkinson's medications , including any levodopa\r\n             preparation administered not less than three times daily, and willing to continue the\r\n             same doses and regimens during study participation\r\n\r\n          -  Experiencing troublesome dyskinesia following levodopa dosing (peak dose dyskinesia)\r\n\r\n          -  Able to understand and complete a standardized PD home diary, following training\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of neurosurgical intervention related to Parkinson's disease (e.g. deep brain\r\n             stimulation)\r\n\r\n          -  History of seizures or stroke/TIA within 2 years of screening\r\n\r\n          -  History of cancer within 5 years of screening, except adequately treated\r\n             non-melanomatous skin cancers, localized bladder cancer, non-metastatic prostate\r\n             cancer or in situ cervical cancer\r\n\r\n          -  Estimated GFR < 50 mL/min/1.73m2\r\n\r\n          -  Presence of cognitive impairment, as evidenced by a Mini-Mental Status Examination\r\n             (MMSE) score of less than 24 during screening\r\n\r\n          -  If female, is pregnant or lactating, or has a positive pregnancy test result pre-dose\r\n\r\n          -  If a sexually active female, is not surgically sterile or at least 2 years\r\n             post-menopausal, or does not agree to utilize an effective method of contraception\r\n             from screening through at least 4 weeks after the completion of study treatment\r\n\r\n          -  Treatment with an investigational drug or device within 30 days prior to screening\r\n\r\n          -  Treatment with an investigational biologic within 6 months prior to screening\r\n      ","sponsor":"Adamas Pharmaceuticals, Inc.","sponsor_type":"Industry","conditions":"Dyskinesia|Levodopa Induced Dyskinesia|Parkinson's Disease","interventions":[{"intervention_type":"Drug","name":"Drug: ADS-5102 (extended release amantadine HCl)","description":"Oral capsules to be administered once daily at bedtime, for 8 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score From Baseline to Week 8","time_frame":"Baseline (Day 1) and Week 8","description":"The UDysRS is a dyskinesia rating scale from 0-104, and it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The last observation carried forward (LOCF) method was used for analysis. Participants were summarized according to the actual treatment received."},{"outcome_type":"secondary","measure":"Change in the Fatigue Severity Score (FSS) From Baseline to Week 8","time_frame":"Baseline (Day 1) and Week 8","description":"The FSS is a 9-item self-reported scale, rating subject experience of fatigue during the previous 7 days. The total score, on a scale from 1-7, is represented by the mean of all answered items. The higher the score, the greater the fatigue severity."},{"outcome_type":"secondary","measure":"Change in Total Objective Score (III, IV) of the UDysRS From Baseline to Week 8","time_frame":"Baseline (Day 1) and Week 8","description":"UDysRS Part III measures objective impairment (dyskinesia severity, anatomic distribution, and type, based on 4 observed activities); and Part IV measures objective disability based on Part III activities. The scores for the 2 Parts combined range from 0-44; a higher score represents more severe dyskinesia."},{"outcome_type":"secondary","measure":"Change in ON Time Without Troublesome Dyskinesia (ON Without Dyskinesia Plus ON With Non-troublesome Dyskinesia) From Baseline to Week 8; Based on a Standardized PD Home Diary","time_frame":"Baseline (Day 1) and Week 8","description":"A PD home diary was used to score 5 different conditions in 30-minute time intervals: ASLEEP, OFF, ON (ie, had adequate control of PD symptoms) without dyskinesia, ON with non-troublesome dyskinesia, and ON with troublesome dyskinesia. The results were based on 2 consecutive 24-hour diaries taken prior to the day of randomization and prior to the Week 8 visit."},{"outcome_type":"secondary","measure":"Change in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Combined Scores (Parts I, II, III) From Baseline to Week 8","time_frame":"Baseline (Day 1) and Week 8","description":"The MDS-UPDRS Parts I, II, and III examined non-motor experiences of daily living, motor experiences of daily living, and motor examination, respectively. Each part had sub scales ranging from normal = 0 to severe = 4."},{"outcome_type":"secondary","measure":"Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8","time_frame":"Baseline (Day 1) and Week 8","description":"The CGI-C consisted of a single question that assessed the investigator's global impression of the subject's change from Baseline in overall PD symptoms, including but not limited to LID. The CGI-C required that the investigator rate the extent to which the subject's PD had improved or worsened (from marked worsening to marked improvement)."}]}
{"nct_id":"NCT02736422","start_date":"2011-07-31","phase":"Phase 1","enrollment":40,"brief_title":"Assessment of New Magnetic Resonance Imaging (MRI) Pulse Sequences for Imaging Hyperpolarised Xenon in Lung, Heart and Brain in Volunteers","official_title":"Assessment of New Magnetic Resonance Imaging (MRI) Pulse Sequences for Imaging Hyperpolarised Xenon in Lung, Heart and Brain in Volunteers","primary_completion_date":"2019-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-12-31","last_update":"2019-06-04","description":"Hyperpolarised gas Magnetic resonance imaging (MRI) (Hyperpolorised 3He and 129Xe MRI) provides novel regional functional images of the lungs. Over the past 14 years researchers at Sheffield Teaching Hospitals NHS Foundation Trust and University of Sheffield have been developing and evaluating different MRI techniques to investigate different aspects of the lung function with both Hyperpolorised 3He and more recently 129Xe gas and have tested these new methods in volunteers with healthy and diseased lungs. This proposed study is to further test the sensitivity of MRI pulse sequences with inhaled 129Xe gas in volunteers. This protocol serves to evaluate the sensitivity of pulse sequences for 129Xe magnetic resonance imaging in the lungs and monitoring the transient changes in vital signs during and following the gas inhalation. This includes evaluation of pulse sequences to image xenon in the heart and brain as well as in the lungs of volunteers.","other_id":"STH15603","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Any sex.\r\n\r\n          -  Age greater than 18, less than 80.\r\n\r\n        NB: Participants will also be permitted to take part in study STH15080 (Eudract number\r\n        2009-010815-34, 'Development of new Magnetic resonance imaging (MRI) pulse sequences for\r\n        probing lung function in volunteers with hyperpolarised 3He gas').\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Contraindication to MRI.\r\n\r\n          -  Resting oxygen saturation less than 90%.\r\n\r\n          -  Known disease of the lungs, heart or brain.\r\n\r\n          -  Pregnant.\r\n\r\n        Volunteer eligibility will be determined by completion of the study screening form not by\r\n        physical examination or testing. Eligibility will be confirmed by a clinician upon review\r\n        of the study screening form, prior to completing the study prescription for xenon dosing.\r\n      ","sponsor":"Sheffield Teaching Hospitals NHS Foundation Trust","sponsor_type":"Other","conditions":"Healthy Volunteers","interventions":[{"intervention_type":"Other","name":"Other: Hyperpolarised Xenon","description":"Hyperpolarised gas Magnetic resonance imaging (MRI) (3He and 129Xe) has enabled novel methods of in-vivo functional lung imaging that do not rely on the use of ionising radiation."}],"outcomes":[{"outcome_type":"primary","measure":"Qualitative assessment of images 3","time_frame":"Baseline","description":"presence of artifacts"},{"outcome_type":"primary","measure":"Qualitative assessment of images 1","time_frame":"Baseline","description":"signal to noise ratio,"},{"outcome_type":"primary","measure":"Qualitative assessment of images 2","time_frame":"Baseline","description":"spatial resolution"}]}
{"nct_id":"NCT00737152","start_date":"2011-07-31","phase":"Phase 2","enrollment":460,"brief_title":"Evaluate the Side Effects and Benefits of RAS 130 With or Without Diet and Exercise in Type II Diabetes Mellitus","official_title":"Phase II, Open-Label Study to Assess the Cardiovascular Side Effects and Efficacy for Reducing Blood Glucose Level in Type II Diabetes Mellitus Patients Being Treated With RAS 130 With or Without Diet and Exercise","primary_completion_date":"2014-04-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2014-04-30","last_update":"2011-07-20","description":"Rationale: RAS 130 is an anti-diabetic agent used to lower the blood glucose level in Type II Diabetes mellitus (non-insulin-dependent diabetes) patients with proper diet and exercise. RAS 130 works by restoring proper response to insulin in the body. RAS 130 acts primarily by increasing insulin sensitivity which improves glycemic index. It is presumed that RAS 130 does not cause cardiovascular side effects if it is given to Type II diabetes mellitus patients leading a healthy life style. Specifically, controlling diet is done according to American Diabetic Association & American Heart Association guidelines and also through doing aerobic exercises. Guideline for aerobic exercise is given in the design of the study. Exercise is helpful in controlling body weight which can lower the risk for heart disease. Diabetes itself is one of the compounding factors for heart diseases. Exercise helps lowering the LDL cholesterol and raising the HDL cholesterol which is required to prevent heart diseases and achieve a better quality of life. Purpose: The aim of this study is to prospectively assess and evaluate the cardiovascular side effects and reduction of blood glucose levels in the Type II Diabetes mellitus patients treated with RAS 130, who either met, or failed to meet criteria for diet and exercise.","other_id":"ASI-DMII 0808","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":30,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patients with Type II Diabetes Mellitus (non-insulin-dependent), not taking any\r\n             anti-diabetic agent.\r\n\r\n          2. Fasting blood glucose level below 250mg/dL\r\n\r\n          3. Age 30 to 60 years\r\n\r\n          4. Both genders\r\n\r\n          5. HbA1c of 6.0% to 13.0%, inclusive\r\n\r\n          6. Body mass index (BMI) below 40 kg/m2\r\n\r\n          7. Female subjects not pregnant, not lactating, post-menopausal, surgically sterile or\r\n             using effective contraceptive measures are included.\r\n\r\n          8. Provide signed Informed Consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Subject unable to give Informed Consent\r\n\r\n          2. Patients with Type I Diabetes Mellitus\r\n\r\n             a. History of ketoacidosis\r\n\r\n          3. Serum creatinine > 2.0 mg or above\r\n\r\n          4. Liver Function Test; Elevated liver enzymes: ALT/AST (2.5 times the upper limit of the\r\n             reference range), Bilirubin Testing - Accept three fold, A/G ratio - Accept two fold\r\n\r\n          5. Hypercholesterolemia (more than 300mg)\r\n\r\n          6. Myocardial Infarction (MI) within 6 months\r\n\r\n          7. Severe or unstable angina\r\n\r\n          8. Elevated triglycerides >500 mg/dL\r\n\r\n          9. Abnormal EKG reading\r\n\r\n         10. Abnormal assessment in stress Echocardiography (ultrasound imaging)for Left\r\n             Ventricular ejection fraction for congestive heart failure\r\n\r\n         11. Anemia (Hb <11 g/dl for men or <10 g/dl for women)\r\n\r\n         12. Blood Dyscrasia, Decrease in Hematocrit - Accept two fold, Low WBC count - Accept one\r\n             fold, Decrease platelet count - Accept three fold\r\n\r\n         13. Macular edema/ macular degeneration\r\n\r\n         14. Patients who are taking insulin\r\n\r\n         15. Subjects with systolic blood pressure >170 mmHg or diastolic blood pressure >90 mmHg\r\n\r\n         16. Active participation in another trial\r\n\r\n         17. Subject physically unable to perform exercise due to neurologic or orthopedic\r\n             conditions.\r\n\r\n         18. Patients taking antipsychotic medications.\r\n\r\n         19. Subjects testing positive for the illicit drugs (cocaine, amphetamines, heroin)\r\n\r\n         20. Subjects who smoke tobacco products\r\n\r\n         21. Females who are lactating, pregnant, or planning to become pregnant\r\n\r\n         22. Signs and symptoms of Congestive heart failure (such as shortness of breath or\r\n             swelling in upper extremities)\r\n\r\n         23. History of severe edema or a medically serious fluid retention\r\n      ","sponsor":"American Scitech International","sponsor_type":"Other","conditions":"Type II Diabetes Mellitus","interventions":[{"intervention_type":"Other","name":"Other: RAS 130 with diet and exercise","description":"Entire population, which will also include existing patients, will be treated with RAS 130 along with diet and exercise. By the end of 6 months: 3 months of study and 3 months of follow-up, the entire population will be divided into two groups which will be determined through endpoints. The first group will be subjects with diet and exercise and the second group will be subjects without diet and exercise. The endpoints for the division of the groups are given in the design of the study."}],"outcomes":[{"outcome_type":"primary","measure":"To determine cardiovascular side effects such as coronary artery disease (CAD) and congestive heart failure (CHF) in patients treated with RAS 130 along with diet and exercise.","time_frame":"6 months"},{"outcome_type":"secondary","measure":"To determine the effect of RAS 130 on reduction of blood glucose level with or without diet and exercise","time_frame":"6 months"}]}
{"nct_id":"NCT01408511","start_date":"2011-07-31","phase":"Phase 2","enrollment":23,"brief_title":"HPA Axis Study in Adults","official_title":"A Multicenter, Open Label Study to Evaluate the Adrenal Suppression Potential of Mapracorat 0.1% Ointment in Adults With Atopic Dermatitis","primary_completion_date":"2011-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-12-31","last_update":"2015-03-20","description":"A multicenter, open-label study to evaluate the adrenal suppression potential of Mapracorat 0.1% ointment in adults with atopic dermatitis.","other_id":"15446","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Signed written informed consent\r\n\r\n          -  Male or female subject aged >= 18 years\r\n\r\n          -  Diagnosis of atopic dermatitis according to Hanifin and Rajka Criteria\r\n\r\n          -  Investigator's Global Assessment (IGA) score of 3 (moderate) to 4 (severe) at baseline\r\n\r\n          -  Normal ACTH response before start of treatment\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnancy or lactation\r\n\r\n          -  Clinically relevant disease, which could interfere with the study conduct or the\r\n             evaluation and interpretation of the study results\r\n\r\n          -  Concomitant medical or dermatological disorder(s), which could interfere with the\r\n             study conduct or the evaluation and interpretation of the study results\r\n\r\n          -  Clinically manifest immunosuppressive disorder or known history of malignant disease\r\n      ","sponsor":"Bayer","sponsor_type":"Industry","conditions":"Atopic Dermatitis|Eczema","interventions":[{"intervention_type":"Drug","name":"Drug: Mapracorat","description":"Application of the investigational product on the affected skin areas"}],"outcomes":[{"outcome_type":"primary","measure":"HPA axis response to Cosyntropin: Number of subjects with adrenal suppression","time_frame":"measured after 4 weeks of therapy"}]}
{"nct_id":"NCT01365208","start_date":"2011-07-31","enrollment":70,"brief_title":"New Approach of Assessing Drug Response for Treatment of Nasopharyngeal Cancer","official_title":"Prospective Evaluation of Plasma EBV DNA Half-life and PET-CT Scanning as a New Tool in Assessing Early Response to Chemotherapy in Patients With Advanced Nasopharyngeal Carcinoma","primary_completion_date":"2017-03-03","study_type":"Observational","rec_status":"Completed","completion_date":"2017-03-03","last_update":"2017-03-24","description":"The combination of pEBV DNA (half-life) and PET-CT following 1 course of chemotherapy allow earlier and more detection of drug response in advanced NPC than RECIST method, in patients with previously untreated advanced NPC who will receive platinum-based chemotherapy. This study will also determine if this new method can predict survival in these patients. This study may have far-reaching impact on drug development in NPC as it may offer a more optimal way of evaluating drug efficacy in clinical trials and also in clinical management.","other_id":"NPC023","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"paitent with advanced nasopharyngeal carcinoma","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  undergo chemotherapy for any one of the following settings:\r\n\r\n               1. Setting 1: Neoadjuvant chemotherapy prior to cheom-RT\r\n\r\n               2. Setting 2: Palliative chemotherapy in Chemonaive patients\r\n\r\n               3. Setting 3: Palliative chemotherapy in previously treated patients (i.e. 2nd line\r\n                  or 3rd line chemo)\r\n\r\n          -  Age >= 18 years\r\n\r\n          -  (ECOG) performance status of 0-2\r\n\r\n          -  have detectable levels of pEBV DNA at baseline\r\n\r\n          -  have measurable tumor sites by RECIST criteria\r\n\r\n          -  have adequate bone marrow, renal and hepatic functions\r\n      ","sponsor":"Chinese University of Hong Kong","sponsor_type":"Other","conditions":"Advanced Nasopharyngeal Carcinoma","interventions":[{"intervention_type":"Drug","name":"Drug: Chemotherapy","description":"platinum-based chemotherapy"}],"outcomes":[{"outcome_type":"secondary","measure":"New method of assessing drug response (measuring tumor metabolic response via FDG-PET & plasma EBV DNA (half-life) after 1 course of chemotherapy) can better predict survival, than the conventional method","time_frame":"3 years"},{"outcome_type":"secondary","measure":"To determine if plasma EBV DNA (half-life) correspond with best response rate based on the conventional 'Response Evaluation Criteria in Solid Tumors' - RECIST criteria.","time_frame":"3 years"},{"outcome_type":"secondary","measure":"overall survival","time_frame":"3 Years"},{"outcome_type":"secondary","measure":"progression free survival","time_frame":"3 Years"},{"outcome_type":"primary","measure":"To determine if measuring tumor metabolic response during chemotherapy can predict survival","time_frame":"3 years"},{"outcome_type":"primary","measure":"To determine if measuring plasma EBV DNA (half-life) early during chemotherapy can predict survival","time_frame":"3 years"}]}
{"nct_id":"NCT01418352","start_date":"2011-07-31","phase":"Phase 3","enrollment":83,"brief_title":"Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder","official_title":"A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Fixed-Dose Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder","primary_completion_date":"2014-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-03-31","last_update":"2015-05-25","description":"The goal of the current trial is to determine efficacy and safety of Once-weekly aripiprazole in reducing Total Tic Severity in children and adolescents with Tourette's Disorder.","other_id":"31-10-273","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":7,"maximum_age":17,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  7 to 17 year old, male or female with DSM-IV-TR diagnostic criteria for TD, confirmed\r\n             by the KSADS-PL, including the Diagnostic Supplement 5\r\n\r\n          -  Has a TTS  20 on the YGTSS at Screening and Baseline\r\n\r\n          -  Presenting tic symptoms cause impairment in the subject's normal routines, which\r\n             include academic achievement, occupational functioning, social activities, and/or\r\n             relationships\r\n\r\n          -  Females of childbearing potential must have a negative pregnancy test, must be\r\n             practicing acceptable double-barrier methods of contraception and must not be pregnant\r\n             or lactating.\r\n\r\n          -  Written ICF obtained from a legally acceptable representative & informed assent at\r\n             Screening as applicable by trial center's IRB/IEC\r\n\r\n          -  The subject, designated guardian(s) or caregiver(s) are able to comprehend and\r\n             satisfactorily comply with the protocol requirements, as evaluated by the\r\n             investigator.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Clinical presentation and/or history, consistent with another neurologic condition\r\n             that may have accompanying abnormal movements.\r\n\r\n          -  History of schizophrenia, bipolar disorder, or other psychotic disorder.\r\n\r\n          -  Subject receiving psychostimulants for treatment of ADD/ADHD and who have developed\r\n             and/or had exacerbations of tic disorder after initiation of stimulant treatment.\r\n\r\n          -  Currently meets DSM-IV-TR criteria for a primary mood disorder.\r\n\r\n          -  Severe OCD, per CY-BOCS score > 16.\r\n\r\n          -  Taken aripiprazole within 30 days of the Screening visit.\r\n\r\n          -  Received any investigational agent in a clinical trial within 30 days prior to\r\n             Screening or who were randomized into a clinical trial with Once-weekly aripiprazole\r\n             at any time.\r\n\r\n          -  History of neuroleptic malignant syndrome.\r\n\r\n          -  Sexually active patients not using 2 approved methods of contraception; breastfeeding\r\n             or pregnant.\r\n\r\n          -  Risk of committing suicide\r\n\r\n          -  Body weight lower than 16 kg\r\n\r\n          -  Taken neuroleptic or antiparkinson drugs < 14 days prior to randomization.\r\n\r\n          -  Requiring CBT for TD during trial.\r\n\r\n          -  Subject meets DSM-IV-TR criteria for any significant psychoactive substance use\r\n             disorder within the past 3 months.\r\n\r\n          -  Positive drug screen\r\n\r\n          -  Subject requires medications not allowed per protocol\r\n\r\n          -  Use of CYP2D6 and CYP3A4 inhibitors or CYP3A4 inducers within 14 days prior to dosing\r\n             and for duration of trial\r\n\r\n          -  Inability to swallow tablets or tolerate oral medication\r\n\r\n          -  Abnormal laboratory test results, vital signs and ECG results\r\n      ","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","sponsor_type":"Industry","conditions":"Tourette's Disorder","interventions":[{"intervention_type":"Drug","name":"Drug: aripiprazole 52.5 mg","description":"Fixed dose of once-weekly aripiprazole tablets for 8 weeks"},{"intervention_type":"Drug","name":"Drug: Matching Placebo","description":"Matching Placebo once-weekly for 8 weeks"},{"intervention_type":"Drug","name":"Drug: Aripiprazole 77.5 mg","description":"Fixed dose of once-weekly aripiprazole tablets for 8 weeks"},{"intervention_type":"Drug","name":"Drug: Aripiprazole 110 mg","description":"Fixed dose of once-weekly aripiprazole tablets for 8 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Primary efficacy measure is change from Baseline to endpoint (week 8) of the Yale Global Tic Severity Scale (YGTSS).","time_frame":"baseline and week 8"},{"outcome_type":"secondary","measure":"The key secondary efficacy endpoints will be the CGI-TS change score at endpoint (week 8) (change score obtained from CGI-TS improvement scale assessment) and the mean changes from Baseline to endpoint (week 8) in GTS-QOL overall score.","time_frame":"baseline and week 8"}]}
{"nct_id":"NCT01382888","start_date":"2011-07-31","phase":"Phase 2","enrollment":30,"brief_title":"Efficacy and Local Tolerability of Topically Applied Heparin on the Suitability of Newly Constructed Primary Arteriovenous Fistulas in Patients Planned for Haemodialysis","official_title":"Efficacy and Local Tolerability of Topically Applied Heparin (Heparin 2,400 IU /ml Cutaneous Spray) on the Suitability of Newly Constructed Primary Arteriovenous Fistulas in Patients Planned for Haemodialysis. A Multicentre, Randomized, Double-blind and Placebo-controlled Pilot Study","primary_completion_date":"2014-04-30","study_type":"Interventional","rec_status":"Terminated","completion_date":"2014-04-30","last_update":"2014-05-08","description":"The primary objective of this study is to evaluate the effect of topically applied heparin in comparison to placebo on suitability of newly constructed primary arteriovenous fistulas in patients planned for haemodialysis at 7th week ( 1 week) after first study drug administration.","other_id":"CYT/Heparin - 01/11","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male and/or female outpatients\r\n\r\n          -  Aged over 18 years\r\n\r\n          -  Stage 4 or 5 Chronic kidney Disease according to KDOQI classification\r\n\r\n          -  Surgery to create an arteriovenous fistula in the lower arm is planned\r\n\r\n          -  If female of childbearing potential: agree to maintain reliable birth control\r\n             throughout the study and negative (urine) pregnancy test\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Known hypersensitivity to any component of the study medication\r\n\r\n          -  History of previous arm (side of planned AVF), neck, or chest surgery/trauma\r\n\r\n          -  Anticipated kidney transplant from living donor within the next 3 months\r\n\r\n          -  Presence of any comorbidity that limits patient's life expectancy to less than 6\r\n             months.\r\n\r\n          -  Pregnancy / lactation or intention to fall pregnant during the time course of the\r\n             study and women of childbearing potential who are not using adequate contraception\r\n\r\n          -  Known bleeding disorder or established diagnosis of active or suspected bleeding\r\n\r\n          -  Platelet count less than 80 x 10^9/L\r\n\r\n          -  Uncontrolled hypertension: Diastolic blood pressure > 115 mm Hg or Systolic blood\r\n             pressure > 200 mm Hg\r\n      ","sponsor":"Cyathus Exquirere Pharmaforschungsgmbh","sponsor_type":"Industry","conditions":"Haemodialysis","interventions":[{"intervention_type":"Drug","name":"Drug: Heparin 2,400 IU /ml Cutaneous Spray","description":"Randomization will be performed 2 - 14 days post fistula creation surgery following confirmation that the fistula is patent by physical examination. Patients that are randomized to this study arm, will be asked to administer the study medication twice daily. Patients will get adequate training before first administration."},{"intervention_type":"Drug","name":"Drug: Placebo Cutaneous Spray","description":"Randomization will be performed 2 - 14 days post fistula creation surgery following confirmation that the fistula is patent by physical examination. Patients that are randomized to this study arm, will be asked to administer the study medication (placebo) twice daily. Patients will get adequate training before first administration."}],"outcomes":[{"outcome_type":"primary","measure":"Dialysis with a blood flow rate ≥ 300 ml/min OR, if the patient is not in need of dialysis, by combining the venous diameter > 0.4 cm and flow volume > 500ml/min assessed by duplex ultrasound, as well as via clinical impression","time_frame":"7 ± 1 week","description":"Primary outcome measure is the suitability of the AVF (dialysis with a blood flow rate ≥ 300 ml/min ) at 7th week (± 1 week) after first study drug administration. Suitability of the AVF will be assessed by using the AVF for dialysis. If a flow rate of at least 300 ml/min can be reached for at least 3 minutes suitability is fulfilled.If the patient is not in need of dialysis, suitability will be assessed by combining the venous diameter > 0.4 cm and flow volume > 500ml/min assessed by duplex ultrasound, as well as via clinical impression"},{"outcome_type":"secondary","measure":"Dialysis with a blood flow rate ≥ 300mL/min. If the patient is not in need of dialysis, by combining the venous diameter > 0.4 cm and flow volume > 500ml/min assessed by duplex ultrasound, as well as via clinical impression.","time_frame":"at 12th and 24th week after first study drug administration","description":"The suitability of the AVF (dialysis with a blood flow rate ≥ 300mL/min) at 12th and 24th week after first study drug administration. If a flow rate of at least 300 ml/min can be reached for at least 3 minutes suitability is fulfilled. If the patient is not in need of dialysis, the suitability will be assessed by combining the venous diameter > 0.4 cm and flow volume > 500ml/min assessed by duplex ultrasound, as well as via clinical impression."},{"outcome_type":"secondary","measure":"The functional (unassisted) patency of AVF","time_frame":"at 7th, 12th and 24th weeks after first study drug administration","description":"Unassisted patency of the AVF will be assessed by palpation and auscultation for at least 30 seconds."},{"outcome_type":"secondary","measure":"Local safety and tolerability profile of IMP by patients and investigator (Global assessment of tolerability)","time_frame":"24 weeks","description":"A scale will be used to assess local tolerability. In addition the investigator will screen for known heparin specific reactions, i.e. skin rash and skin swelling."}]}
{"nct_id":"NCT01373034","start_date":"2011-07-31","phase":"N/A","enrollment":36,"brief_title":"The Effects of Soy Dietary Fiber in Adults With Diarrhea Predominant Irritable Bowel Syndrome","official_title":"The Effects of Soy Dietary Fiber in Adults With Diarrhea Predominant Irritable Bowel Syndrome: Double-blind, Randomized, Placebo-controlled, Cross Over Clinical Trial","primary_completion_date":"2012-07-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2012-07-31","last_update":"2011-06-14","description":"The investigators will evaluate the efficacy of soy dietary fiber in adults with diarrhea predominant irritable bowel syndrome.","other_id":"CHUNG_SOY","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":19,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  willing to consent/undergo necessary procedures\r\n\r\n          -  between the age of 19 and 75 years\r\n\r\n          -  diarrhea predominant irritable bowel syndrome (satisfied with Rome II criteria)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  uncontrolled hypertension (Blood pressure > 170/100 mmHg)\r\n\r\n          -  uncontrolled diabetes mellitus (FBS > 180 mg/dL)\r\n\r\n          -  malignancy, cerebrovascular disease, cardiovascular disease\r\n\r\n          -  history of abdominal surgery except appendectomy and hernia repair\r\n\r\n          -  inflammatory bowel disease\r\n\r\n          -  clinically or laboratory-confirmed gastroenteritis\r\n\r\n          -  the use of motility drug or dietary fiber supplement in 2 weeks\r\n\r\n          -  allergy to soy fiber\r\n\r\n          -  serum Cr > 2 x Upper normal limit\r\n\r\n          -  AST or ALT > 2 x Upper normal limit\r\n\r\n          -  Pregnancy, Lactating woman\r\n      ","sponsor":"Seoul National University Hospital","sponsor_type":"Other","conditions":"Diarrhea Predominant Irritable Bowel Syndrome","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Soy Dietary Fiber","description":"Soy Dietary Fiber, Once a day, before meal, 1 pack(20g), per oral with water 90mL"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Rice powder","description":"Rice powder, Once a day, before meal, 1 pack(20g), per oral with water 90mL"}],"outcomes":[{"outcome_type":"primary","measure":"sum of irritable bowel syndrome symptom score","time_frame":"after 4 weeks","description":"abdominal pain / abdominal discomfort urgency tenesmus abdominal distension"},{"outcome_type":"secondary","measure":"irritable bowel syndrome symptom score","time_frame":"after 2 weeks and 4 weeks","description":"abdominal pain / abdominal discomfort urgency tenesmus abdominal distension"},{"outcome_type":"secondary","measure":"Stool frequency and form","time_frame":"after 2 weeks and 4 weeks","description":"Stool frequency (greater than 3 bowel movements/day or less than 3 bowel movements/week) Stool form (lumpy / hard or loose / watery stool)"},{"outcome_type":"secondary","measure":"Symptom control of irritable bowel syndrome","time_frame":"after 2 weeks and 4 weeks"},{"outcome_type":"secondary","measure":"Improvement of overall symptom in patient with irritable bowel syndrome","time_frame":"after 2 weeks and 4 weeks"},{"outcome_type":"secondary","measure":"Severity of overall symptom in patient with irritable bowel syndrome","time_frame":"after 2 weeks and 4 weeks"},{"outcome_type":"secondary","measure":"Severity of diarrhea","time_frame":"after 2 weeks and 4 weeks"},{"outcome_type":"secondary","measure":"Assessment for quality of life related with irritable bowel syndrome","time_frame":"after 2 weeks and 4 weeks"},{"outcome_type":"secondary","measure":"Assessment for patient satisfaction after administration completion","time_frame":"after 2 weeks and 4 weeks","description":"Overall satisfaction for treatment Whether the patient will keep up treatment"}]}
{"nct_id":"NCT01390675","start_date":"2011-06-30","enrollment":7000,"brief_title":"Anesthesia for Catheter Aortic Valve ImplantATIOn Registry","official_title":"Anesthesia for Catheter Aortic Valve ImplantATIOn Registry","primary_completion_date":"2024-12-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2025-12-31","last_update":"2021-02-03","description":"In modern cardiac surgery and cardiology Transcatheter Aortic Valve Implantation (TAVI) is an emerging procedure for high-risk patients that are assumed to be otherwise inoperable. The investigators want to evaluate the specific intraoperative anesthesiologic characteristics cardiac anesthesiologists have to face during these procedures.","other_id":"GE DHM-AN-OR-2011/04","observational_model":"Other","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"Patients undergoing transcatheter aortic valve implantation (TAVI)","criteria":"\n        Inclusion Criteria:\r\n\r\n        - Patients undergoing transcatheter aortic valve implantation (TAVI)\r\n\r\n        Exclusion Criteria:\r\n\r\n        - Refusal by patient\r\n      ","sponsor":"Deutsches Herzzentrum Muenchen","sponsor_type":"Other","conditions":"Heart Failure|Excessive Amount of Blood / Fluid Transfusion|Intraoperative Cardiac Arrest During Cardiac Surgery|Critical Incident|Anesthesia|Failed Conscious Sedation During Procedure","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Perioperative Care","time_frame":"1 day","description":"major critical adverse events"},{"outcome_type":"secondary","measure":"Up to 10 years","time_frame":"10 Years","description":"all-cause mortality"}]}
{"nct_id":"NCT01372124","start_date":"2011-06-30","phase":"Phase 1","enrollment":32,"brief_title":"A Phase I Clinical Trial to Evaluate the Effect of Renal Impairment on Pharmacokinetics of NOX-E36","official_title":"A Phase I, Open Label, Parallel Group, Multi-center Single Dose Trial to Evaluate the Effect of Renal Impairment on Pharmacokinetics of NOX-E36","primary_completion_date":"2012-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-10-31","last_update":"2012-10-19","description":"This is a multi center, open label, parallel group, single administration, phase I trial, in subjects with mild, moderate or severe renal impairment and a control group with normal renal function.","other_id":"SNOXE36C201","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Male and female subjects (age 18-75 years, both inclusive)\r\n\r\n          2. Male subjects who agree to sexual abstinence and/or use a highly effective method of\r\n             birth control. Female partners of male subjects must be of non-child bearing potential\r\n             or must practice an adequate non-hormonal contraceptive method to prevent pregnancies.\r\n\r\n          3. Subjects will be categorized as follows based on creatinine clearance(mL/min/1.73m2):\r\n             Normal renal function: CrCl > 80; mild renal impairment: 50  CrCl  80; moderate\r\n             renal impairment: 30  CrCl  50; severe renal impairment: CrCl < 30\r\n\r\n          4. Body Mass Index (BMI) between 22 and 40 kg/m, both inclusive.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Women of childbearing potential\r\n\r\n          2. Patients who have received kidney transplantation.\r\n\r\n          3. Patients receiving hemodialysis to control their disease.\r\n\r\n          4. Any clinically significant abnormality other than related to the renal impairment\r\n             following the investigator's review of the physical examination, ECG and clinical\r\n             laboratory tests at screening.\r\n\r\n          5. Not able to communicate meaningfully with the investigator and staff.\r\n      ","sponsor":"NOXXON Pharma AG","sponsor_type":"Industry","conditions":"Renal Impairment","interventions":[{"intervention_type":"Drug","name":"Drug: NOX-E36","description":"All subjects included in this study will receive the same dose of NOX E36. In previous clinical trials, single intravenous doses of NOX E36 up to 2 mg/kg body weight and single subcutaneous doses of up to 0.5 mg/kg body weight appeared to be safe and well tolerated in healthy volunteers. Pharmacokinetic analyses have shown dose linearity"}],"outcomes":[{"outcome_type":"primary","measure":"Pharmacokinetics"}]}
{"nct_id":"NCT01400828","start_date":"2011-06-30","phase":"Phase 3","enrollment":239,"brief_title":"Investigate the Safety/Tolerability and Efficacy of Bilastine 20mg in Korean Patients With Seasonal Allergic Rhinitis","official_title":"Randomized, Double-blind, Placebo/Active-controlled, Multi-center Clinical Trial to Investigate the Safety/Tolerability and Efficacy of Bilastine 20mg After 14-day Oral Administration in Patients With Seasonal Allergic Rhinitis","primary_completion_date":"2013-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-05-31","last_update":"2014-07-10","description":"The objective of the study was to determine the efficacy and tolerability of 20 mg of Bilastine, compared to Desloratadine and placebo for the treatment of Seasonal Allergic Rhinitis.","other_id":"YCD159","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":12,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  The study disease was diagnosed on the basis of clinical criteria: Nasal symptoms\r\n             (presence of nasal blockage, sneezing, nasal itching and rhinorrhea) and non-nasal\r\n             symptoms (ocular itching, lacrimation, itching of ears and/or palate and ocular\r\n             redness), as well as the skin prick test performed at the time of selection or within\r\n             the year prior to entering.\r\n\r\n          -  Patients with history of Seasonal Allergic Rhinitis, positive skin prick test and\r\n             symptoms were included if they were between 12 and 70 years old, gave their informed\r\n             consent, attended the required visits scheduled and also underwent a complete medical\r\n             examination..\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients were excluded if they had a significant nasal abnormality which could\r\n             interfere with the aim of the study, acute or chronic sinusitis, asthma or any\r\n             condition, disease or hypersensitivity that could be harmed.\r\n\r\n          -  Patients were not allowed to take forbidden medications or not comply the study\r\n             requirements.\r\n\r\n          -  Patients who were currently participating in or had participated in another clinical\r\n             trial within the previous three months or were planning to travel outside of the study\r\n             area during the course of the study were excluded.\r\n\r\n          -  Pregnant or breast-feeding women were also excluded.\r\n\r\n          -  Women of childbearing potential had a pregnancy test done\r\n      ","sponsor":"Yuhan Corporation","sponsor_type":"Industry","conditions":"Seasonal Allergic Rhinitis","interventions":[{"intervention_type":"Drug","name":"Drug: Bilastine","description":"20 mg (encapsulated) tablets QD/14 days"},{"intervention_type":"Drug","name":"Drug: Desloratadine","description":"5 mg (encapsulated) tablets QD/14 days"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"(encapsulated) Tablets QD/14 days"}],"outcomes":[{"outcome_type":"primary","measure":"AUC of TSS","time_frame":"14 days","description":"The area under curve (AUC) of the total symptom score (TSS) since basal visit to D14 visit according to the patient's assessment"},{"outcome_type":"secondary","measure":"Change in TSS. Reflective symptoms","time_frame":"14 days","description":"Change in the reflective total score on symptom scale on D14 visit and day7 visit versus D0 visit (baseline) according to the patient´s assessment on the previous 12 hours."},{"outcome_type":"secondary","measure":"Change in TSS. Instantaneous score","time_frame":"14days","description":"Change in the total score on symptom scale on D7 and D14 visits versus D0 visit (baseline) according to the patient's assessment (instantaneous score)."},{"outcome_type":"secondary","measure":"Change in total nasal symptom score (TNSS)","time_frame":"14 days","description":"Change in nasal symptom score on symptom scale on D7 and D14 visits versus D0 visit (baseline) according to the patient's and investigator's assessment"},{"outcome_type":"secondary","measure":"•Change in total non-nasal symptom score (TNNSS)","time_frame":"14 days","description":"Change in non-nasal symptom score on symptom scale on D7 and D14 visits versus D0 visit (baseline) according to the patient's and investigator's assessment"},{"outcome_type":"secondary","measure":"VAS of discomfort","time_frame":"14 days","description":"Overall assessment of discomfort caused by allergic rhinitis using a visual analog scale (VAS) on D7 and D14 versus D0."},{"outcome_type":"secondary","measure":"CGI","time_frame":"14 days","description":"Investigator's overall clinical impression (CGI)"},{"outcome_type":"secondary","measure":"•Allergic rhinitis (AR) quality of life (QoL) questionnaire (RQLQ)","time_frame":"14 days","description":"Quality of Life change versus baseline."},{"outcome_type":"secondary","measure":"responde's rate","time_frame":"14 days","description":"Patients were analysed based on their total symptoms score decrease from baseline (<25%, 25%-50%, 50%-75%, >75%)."},{"outcome_type":"secondary","measure":"safety assessment","time_frame":"14 days","description":"comparison of the adverse event profiles throughout the course of the study, ECGs and safety blood tests on D0 and D14."}]}
{"nct_id":"NCT02164292","start_date":"2011-06-30","enrollment":30,"brief_title":"ALPPS: Safety, Feasibility and Efficacy at a Single Center","official_title":"Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy (ALPPS): Safety, Feasibility and Efficacy at a Single Center","primary_completion_date":"2014-04-30","study_type":"Observational","rec_status":"Completed","completion_date":"2014-04-30","last_update":"2019-08-13","description":"The possibility to achieve a curative resection in patients with liver malignancies is limited by the future liver remnant (FLR). The Associating Liver Partition and Portal vein ligation for Staged hepatectomy (ALPPS) approach has recently been introduced as a revolutionary strategy to achieve resectability by inducing a rapid and large FLR hypertrophy. However, the possibility of achieving a short-term hypertrophy and high resectability rates has been counteracted in most published series by an increased risk of morbidity and mortality.The aim of this study was to evaluate the results with the ALPPS procedure in a single high-volume HPB center, with special emphasis in the safety and feasibility of this new 2-stage strategy. The aim of the present study was to assess the safety, feasibility and efficacy of ALPPS in a single high-volume hepatobiliary center.","other_id":"1942","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":85,"population":"High-Volume University Hospital population","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with marginally resectable or primarily non-resectable locally advanced liver\r\n             tumors\r\n\r\n          -  Insufficient FLR either in volume or quality\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Unresectable liver metastases in the future liver remnant or unresectable extrahepatic\r\n             metastases\r\n\r\n          -  Severe portal hypertension\r\n\r\n          -  High anesthesiological risk\r\n\r\n          -  Unresectable primary tumor\r\n      ","sponsor":"Hospital Italiano de Buenos Aires","sponsor_type":"Other","conditions":"Locally Advanced Malignant Liver Disease","interventions":[{"intervention_type":"Procedure","name":"Procedure: ALPPS","description":"Associating Liver Partition and Portal vein ligation for Staged hepatectomy"}],"outcomes":[{"outcome_type":"primary","measure":"Safety of the procedure defined as the incidence of postoperative complications and mortality","time_frame":"within the first 90 days after the first stage","description":"Ocurrence of any postoperative complication or mortality considering the Dindo-Clavien classification of surgical complications"},{"outcome_type":"primary","measure":"Feasibility of the procedure defined as percentage of patients that complete both surgical stages.","time_frame":"within 4 months after the first stage","description":"Percentage of patients that finally arrive to the 2nd stage of the ALPPS approach"},{"outcome_type":"secondary","measure":"Efficacy of the procedure defiend as the percentage of patients who achieve a sufficient future liver remnant hypertrophy","time_frame":"within 10 days after the first stage","description":"Achievement of sufficient short-term hypertrophy of the future liver remnant (FLR). Sufficiency was defined as a FLR >0.5% of body weight or >25% of standardized total liver volume in case of healthy liver parenchyma, or >0.8% and 40% in case of diseased parenchyma."},{"outcome_type":"secondary","measure":"Disease-free survival and overall survival","time_frame":"1 and 2 years","description":"Disease free survival was the time that a patient remained alive and without evidence of disease from the second stage. Overall survival was the time from the first stage to patient death."},{"outcome_type":"secondary","measure":"Risk factors for morbidity","time_frame":"within 3 month after the first stage","description":"To identify clinical or operative risk factors of postoperative complications"},{"outcome_type":"secondary","measure":"Risk factors for a reduced kinetic growth rate of the future liver remnant (<35 cc/day)","time_frame":"within 3 months after the first stage","description":"To identify clinical or operative risk factors or a reduced kinetic growth rate of the future liver remnant (<35 cc/day)"}]}
{"nct_id":"NCT01880112","start_date":"2011-06-30","phase":"Phase 4","enrollment":0,"brief_title":"Serum and Tissue Cefazolin Concentrations in Normal Weight Patients Undergoing Cesarean Delivery.","official_title":"Serum and Tissue Cefazolin Concentrations in Normal Weight Patients Undergoing Cesarean Delivery Receiving Two Differing Doses of Pre-operative Cefazolin.","primary_completion_date":"2013-06-30","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2013-06-30","last_update":"2013-06-18","description":"Patients undergoing Cesarean delivery (C-Section) with a body mass index of 30 or less will be given either 2 grams or 4 grams of an antibiotic before surgery. The antibiotic is intended to prevent infection from the surgery. It is unknown what the best dose for the usual medicine used for this purpose (an antibiotic medicine called cefazolin). Samples of the tissue just under the skin will be biopsied at the time the incision is made and at the time the cut is stitched or stapled closed. A sample of the muscle of the womb will be taken as the womb is stitched closed after the delivery. Blood tests will be done at the start and end of surgery to test the antibiotic level. A blood sample will be taken from the umbilical cord after the baby has been delivered and the umbilical cord has been cut. The umbilical cord blood sample will be tested for the antibiotic level. These tests will be used to find out if the usual dose of medicine is enough or if more medicine is needed to prevent infection in normal weight women undergoing c-sections.","other_id":"H-23256","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"Single","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age 18 years or above\r\n\r\n          2. Body mass index (BMI) of 30 or less, as calculated from the height and weight at the\r\n             first prenatal visit\r\n\r\n          3. Undergoing cesarean delivery\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. BMI greater than 30.\r\n\r\n          2. Not undergoing Cesarean delivery.\r\n\r\n          3. Age less than 18 years.\r\n\r\n          4. Pre-existing infection.\r\n\r\n          5. Allergy to cephalosporin medications or a history of an anaphylactic reaction to\r\n             penicillin.\r\n\r\n          6. Cesarean delivery being performed under emergent circumstances\r\n      ","sponsor":"West Virginia University","sponsor_type":"Other","conditions":"Infection|Cesarean Delivery|Antibiotic Prophylaxis","interventions":[{"intervention_type":"Drug","name":"Drug: Cefazolin","description":"Cefazolin will be administered as pre-operative prophylaxis in normal weight patients undergoing Cesarean delivery. Tissue and serum levels will be measured at the time of the incision and when the incision is closed."}],"outcomes":[{"outcome_type":"primary","measure":"Cefazolin drug level.","time_frame":"Tissue and blood samples will be drawn during the surgical case only. Duration expected to be less than 120 minutes.","description":"Measurement of the serum and tissue level of cefazolin."}]}
{"nct_id":"NCT01376453","start_date":"2011-06-30","phase":"Phase 1","enrollment":18,"brief_title":"Pre-operative 5-Fluorouracil (5-FU) and Sorafenib With External Radiation in Locally Advanced Rectal Cancer","official_title":"Phase I Study of Pre-operative Continuous 5-FU, and Sorafenib With External Radiation Therapy in Locally Advanced Rectal Adenocarcinoma","primary_completion_date":"2014-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-03-31","last_update":"2016-09-12","description":"The main purpose of this study is to find the maximum tolerable dose of sorafenib when administered along with another drug called 5-Fluorouracil (5-FU) and to find out more about whether these drugs, along with radiation, can help people with rectal cancer when given before surgery. 5-FU and radiation are both approved by the US Food and Drug Administration (FDA) for use in people with rectal cancer. The investigators will utilize a standard 3 + 3 phase I study design. In the phase I part of the study, the investigators will attempt dose escalation of sorafenib in combination with standard infusional 5-FU and external beam at standard doses. Clinical staging should be done by endorectal ultrasound (ERUS) and/or pelvic magnetic resonance imaging (MRI) for T and N stage; chest and abdomen computed tomography (CT) for staging of metastatic disease; undergo sigmoidoscopy and/or colonoscopy done by crude odds ratios (CORS); biopsy is taken for diagnosis and extra is sent for tissue bank. At the maximum tolerated dose (MTD) of sorafenib we will expand the cohort to 6 more patients to further evaluate toxicity profile and efficacy.","other_id":"MCC-16475","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically confirmed adenocarcinoma of the rectum that begins within 12 cm of the\r\n             anal verge as determined by sigmoidoscopy and/or colonoscopy with no evidence of\r\n             distant metastasis\r\n\r\n          -  Locally advanced rectal cancer determined by any of the following features: Fixed or\r\n             immobile tumor on physical exam and/or; T3 disease with invasion through the\r\n             muscularis propria as defined by transrectal ultrasound, CT or MRI; T4 disease with\r\n             invasion of adjacent structures such as pelvic sidewall, sacrum, pelvis, bladder\r\n             and/or prostate as determined appropriate imaging modalities such as ultrasound, CT or\r\n             MRI; Any T with + N on CT scan/MRI or transrectal ultrasound\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1\r\n\r\n          -  Adequate bone marrow, liver and renal function as assessed by the following:\r\n             Hemoglobin > 9.0 g/dl, Absolute neutrophil count (ANC) > 1,500/mm^3, Platelet count >\r\n             100,000/mm^3, Total bilirubin < 1.5 times upper limit of normal (ULN), alanine\r\n             aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 times the ULN ( < 5\r\n             x ULN for patients with liver involvement), Creatinine < 1.5 times ULN\r\n\r\n          -  Women of childbearing potential must have a negative serum pregnancy test performed\r\n             within 7 days prior to the start of treatment\r\n\r\n          -  Women of childbearing potential and men must agree to use adequate contraception\r\n             (barrier method of birth control) prior to study entry and for the duration of study\r\n             participation. Men should use adequate birth control for at least three months after\r\n             the last administration of sorafenib.\r\n\r\n          -  Ability to understand and the willingness to sign a written informed consent. A signed\r\n             informed consent must be obtained prior to any study specific procedures.\r\n\r\n          -  Patients receiving anti-coagulation treatment with an agent such as warfarin or\r\n             heparin will be allowed to participate. For patients on warfarin, the INR should be\r\n             measured prior to initiation of sorafenib and monitored at least weekly, or as defined\r\n             by the local standard of care, until international normalized ratio (INR) is stable.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Cardiac disease: Congestive heart failure > class II New York Heart Association\r\n             (NYHA). Patients must not have unstable angina (anginal symptoms at rest) or new onset\r\n             angina (began within the last 3 months) or myocardial infarction within the past 6\r\n             months.\r\n\r\n          -  Pelvic irradiation therapy.\r\n\r\n          -  Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.\r\n\r\n          -  Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic\r\n             pressure > 90 mmHg, despite optimal medical management.\r\n\r\n          -  Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.\r\n\r\n          -  Active clinically serious infection > Common Terminology Criteria for Adverse Events\r\n             (CTCAE) Grade 2.\r\n\r\n          -  Thrombolic or embolic events such as a cerebrovascular accident including transient\r\n             ischemic, attacks, deep vein thrombosis (DVT) within the past 6 months.\r\n\r\n          -  No active malignancy except for nonmelanoma skin cancer or in situ cervical cancer or\r\n             Treated non-pelvic cancer from which the patient has been continuously disease free\r\n             more than five years.\r\n\r\n          -  Needing medical attention for serious bleeding in past 4 weeks.\r\n\r\n          -  Previous chemotherapy except for antiangiogenic agent or tyrosine kinase inhibitor\r\n             (TKI) will be allowed as long as it is more than 5 years.\r\n\r\n          -  Evidence or history of bleeding diathesis\r\n\r\n          -  Use of St. John's Wort or rifampin\r\n\r\n          -  Known or suspected allergy to sorafenib or any agent given in the course of this\r\n             trial.\r\n\r\n          -  Any condition that impairs patient's ability to swallow whole pills.\r\n\r\n          -  Any malabsorption problem.\r\n      ","sponsor":"H. Lee Moffitt Cancer Center and Research Institute","sponsor_type":"Other","conditions":"Rectal Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Sorafenib","description":"In addition to radiation and 5-FU, sorafenib will be taken by mouth daily every day until the last day of radiation. The dose of sorafenib will be one of the following: 200 mg every other day, 200 mg daily, 400 mg daily, or 800 mg daily"},{"intervention_type":"Drug","name":"Drug: 5-Fluorouracil (5-FU)","description":"5-FU will be delivered at a dose of 225 mg/m^2 daily through a catheter in a large vein continuously until the last day of radiation."},{"intervention_type":"Radiation","name":"Radiation: Radiation","description":"Radiation sessions will be daily, Monday through Friday, except for holidays."}],"outcomes":[{"outcome_type":"primary","measure":"Maximum Tolerated Dose (MTD)","time_frame":"Start of treatment through end of follow up - average of 21 weeks","description":"To determine maximally tolerated dose of sorafenib when delivered concurrently with 5-FU and external beam radiation in patients with locally advanced rectal adenocarcinoma"},{"outcome_type":"secondary","measure":"Number of Participants With Pathologic Response","time_frame":"Start of treatment through end of follow up - average of 21 weeks","description":"To determine the pathologic response rate after pre-operative therapy and surgery"},{"outcome_type":"secondary","measure":"Number of Participants With Serious Adverse Events (SAEs)","time_frame":"Start of treatment through end of follow up - average of 21 weeks","description":"To further define safety profile of the combination. During the 5 1/2 weeks of radiation, participants will be seen in the study clinic and will have blood tests weekly."}]}
{"nct_id":"NCT01622153","start_date":"2011-06-30","phase":"N/A","enrollment":120,"brief_title":"Electrical and Formocresol Pulpotomy in Primary Molars","official_title":"A Prospective Study and Clinical Evaluation of Pre & Post Operative Treatment Comparison of Electrical and Formocresol Pulpotomy Procedures in Primary Molars of Children Undergoing General Anesthesia","primary_completion_date":"2014-06-30","study_type":"Interventional","rec_status":"Terminated","completion_date":"2014-06-30","last_update":"2017-05-10","description":"1. The investigator hypothesize that the Laser pulpotomy will provide adequate and comparable success clinically in primary molars. 2. The investigators hypothesize that the Laser pulpotomy will provide adequate and comparable success radiographically in primary molars.","other_id":"021117","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":3,"maximum_age":8,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Restorable carious primary molars with reversible pulpitis and free of clinical or\r\n             radiographic signs of pulp pathology\r\n\r\n          2. Males and females\r\n\r\n          3. Children ages 3-8 years old\r\n\r\n          4. Children classified under ASA I or II status\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Excluded will be primary molars with clinical or radiographic signs of pathology\r\n\r\n          2. Children not within age range\r\n\r\n          3. Absence of parent/caregiver\r\n\r\n          4. Mentally disabled parent/caregiver\r\n\r\n          5. Patients not returning for 6 month and 12 month follow up examination appointment\r\n      ","sponsor":"University Hospitals Cleveland Medical Center","sponsor_type":"Other","conditions":"Reversible Pulpitis|Caries","interventions":[{"intervention_type":"Procedure","name":"Procedure: Formocresol application after pulpotomy preparation","description":"1:5 Buckley's Formocresol dilution applied for 5 minutes or until hemostasis achieved"},{"intervention_type":"Procedure","name":"Procedure: GENTLEray 980 Soft Tissue diode laser","description":"Application to pulp chamber until hemostasis achieved"}],"outcomes":[{"outcome_type":"primary","measure":"Radiographic","time_frame":"6, 12, and 18 months","description":"Failure is identified as radiographic: furcation radiolucency, external root resorption"},{"outcome_type":"secondary","measure":"Clinical","time_frame":"6, 12, 18 months","description":"Failure determined by clinical presence of: mobility, abscess, spontaneous pain, suppuration"}]}
{"nct_id":"NCT01563250","start_date":"2011-06-30","phase":"Phase 4","enrollment":705,"brief_title":"Improving the Management of Acute Coronary Syndromes in the Emergency Department","official_title":"Improving the Management of Acute Coronary Syndromes in the Emergency Department Using a Rapid Acute Cardiac Evaluation Pathway","primary_completion_date":"2011-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-12-31","last_update":"2013-04-04","description":"By using a Rapid Cardiac Evaluation (RACE) pathway in the Emergency Department (ED), the investigators can effectively reduce ED wait times and ED length of stay by decreasing overall hospital admissions and telemetry admissions. In addition, the investigators hypothesize a decrease in mortality of those patients admitted for cardiac evaluation by increasing the patient to health care provider ratio.","other_id":"IMR-001","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":35,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Chief complaint of chest pain\r\n\r\n          -  35 years old or greater\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  ST elevation MI\r\n\r\n          -  New Left Bundle Branch Block\r\n\r\n          -  Admission regardless of test result\r\n\r\n          -  Leaving ED against medical advice\r\n      ","sponsor":"Integrated Medical Research LLC","sponsor_type":"Other","conditions":"Acute Coronary Syndrome","interventions":[{"intervention_type":"Device","name":"Device: Point of Care testing","description":"The investigators will implement 6 months of randomized testing periods, 2 weeks each. During this 2 week block, cardiac biomarkers will be tested at the bedside in the ED using the Triage Cardiac Panel that will test for CK-MB, Myoglobin, and Troponin I.\r\nEach blood sample that is take for point of care testing will be saved. The plasma from the saved sample will be frozen and the sample will be sent to an off-site testing center for high sensitivity troponin testing.\r\nAll patients will be followed at the 30-day mark and those patients who are discharged home from the ED will be followed within 48 hours as well."}],"outcomes":[{"outcome_type":"primary","measure":"ED length of stay","time_frame":"Average of 3 hours stay in the Emergency Department","description":"From patient check-in time to patient admit or discharge time"},{"outcome_type":"secondary","measure":"Mortality rate of admitted patients","time_frame":"During hospital admission and at 30 days","description":"Average hospital stay 3 days."},{"outcome_type":"secondary","measure":"Hospital Admission Rate","time_frame":"Baseline","description":"Observing the rate at which physicians admit patients to the hospital."}]}
{"nct_id":"NCT02865590","start_date":"2011-06-30","phase":"N/A","enrollment":16,"brief_title":"Clinical and Histological Evaluation of Deproteinizated Bovine Bone Allograft and Lyophilized Equine Bone Allograft for Sinus Lift.","official_title":"Clinical and Histological Evaluation of Demineralized Bone Allograft and Lyophilized Equine Bone Allograft for Sinus Lift: Double Blind, Parallel, Randomized Clinical Trial.","primary_completion_date":"2015-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-10-31","last_update":"2020-03-23","description":"The sinus infiltration technique for sinus floor elevation has been used successfully when a reduced vertical height is available in the posterior maxilla. However, the effect of the different graft material on the volume and on the quality of new bone formed has not been fully investigated. The aim of this study is to evaluate the clinical and histological effect of a test material, lyophilized equine bone (Bio-gen), compared with control material, deproteinized bovine bone (Endobon), in the sinus lift techniques with lateral approach.","other_id":"Prot.001/luglio2010","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  bilateral atrophy of the maxilla;\r\n\r\n          -  bone ridge <= 6mm\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  severe systemic diseas (ASA III -IV) bisphosphonate therapy or a history of up to 3\r\n             years history of radiation therapy to neck and head area sinusitis pregnancy subjects\r\n             not able to consent to participate in the study.\r\n      ","sponsor":"University of L'Aquila","sponsor_type":"Other","conditions":"Maxillary Sinus Floor Augmentation","interventions":[{"intervention_type":"Device","name":"Device: sinus lift with Lyophilized Equine Bone Allograft (Bio-gen , Bioteck s.p.a., Arcugnano (VI) - Italy)"},{"intervention_type":"Device","name":"Device: Sinus lift with deproteinized bovine bone allograft (Endobon Xenograft Granules, Zimmer Biomet, San Donato Milanese (MI) - Italy)"}],"outcomes":[{"outcome_type":"primary","measure":"Histomorphometric Evaluation of New Bone Formation.","time_frame":"6 months"}]}
{"nct_id":"NCT01397058","start_date":"2011-06-30","enrollment":275,"brief_title":"Reactivation of CMV Infection in Immunocompetent Patients Under Severe Stress","official_title":"Observational Study of CMV Reactivation in Immunocompetent Children and Adult ICU Patients","primary_completion_date":"2015-05-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2015-06-30","last_update":"2011-08-15","description":"Background. Human herpes viruses establish lifelong latency after primary infection and may reactivate in immunosuppressed patients causing significant morbidity and mortality. In immunocompetent patients, although reactivation may occur disease development is deterred by the competent host immune response. Recent studies indicate that approximately one third of CMV seropositive immunocompetent ICU patients present with CMV reactivation associated with poor outcome, potentially secondary to the stress incurred. CMV reactivation among immunocompetent critically ill children has not been assessed. Study Hypothesis: Identifiable risk factors associated with CMV reactivation exist and may be used for future assessment of antiviral prophylaxis administration. Aim: Primary aim is to identify risk factors associated with CMV reactivation and poor outcome in immunocompetent children and adults under severe stress. Whether CMV reactivation occurs in critically ill children and its clinical implications remains to be determined. Secondary aim is to study the role of cellular signaling pathways of inflammation and specific adaptive immunity during this process. Work packages: A multicenter observational prospective study will be conducted among CMV seropositive pediatric and adult ICU patients. Patient clinical progress, laboratory findings, management, and complications will be recorded during the 28 days following ICU admission. Salivary free cortisol levels, plasma catecholamines, and serum cytokines levels will be measured to assess stress. CMV reactivation will be evaluated weekly by detecting CMV-DNA in peripheral blood and bronchial wash samples with real-time PCR. In a patient subsample, the nuclear factor B and intracellular GC receptor will be measured in peripheral blood monocytes to study cellular signaling pathways of inflammation. The adaptive immune response to CMV infection following in vitro viral polypeptide stimulation will be prospectively examined in a subset of patients. Expected Results: The study will provide original data on critically ill children. Further knowledge regarding risk factors associated with CMV reactivation and poor outcome will be accumulated. Novel information regarding the role of cellular inflammation and specific adaptive immune responses during CMV reactivation will be gathered.","other_id":"UAthens","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":2,"population":"ICU patients","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  previously healthy children 5-16 years old (group A) and adults (group B)\r\n\r\n          -  no known immunosuppression (secondary to underlying disease or medications),\r\n\r\n          -  residence near the ICU (ability to return for follow up on day 28 post admission)\r\n\r\n          -  availability of patient guardian or first degree relative willing to provide written\r\n             informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  imminent death\r\n\r\n          -  expected ICU stay <48 hours\r\n\r\n          -  intubation prior to admission (in a different center) for >48 hours\r\n      ","sponsor":"University of Athens","sponsor_type":"Other","conditions":"Cytomegalovirus Viraemia|Stress, Physiological|Receptor, Hormonal; Disorder|Other Deficiency of Cell-mediated Immunity","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Risk factors associated with CMV reactivation in critically ill children and adults","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Role of cellular signaling and adaptive immunity","time_frame":"7 days"}]}
{"nct_id":"NCT01394250","start_date":"2011-06-30","phase":"Phase 2","enrollment":240,"brief_title":"Vibrating, Cold Device for Pediatric Intravenous (IV) Cannulation Pain Relief","official_title":"Testing the Efficacy of a Vibrating, Cold Device for Pediatric IV Cannulation Pain Relief in the Emergency Department","primary_completion_date":"2013-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-09-30","last_update":"2016-09-16","description":"The purpose of this study is to test the effectiveness of Buzzy, a battery-powered reusable device that provides cold and vibration, in reducing the pain associated with intravenous (IV) cannulation. The investigators will investigate if Buzzy is as effective as topical lidocaine cream in reducing the pain associated with IV cannulation.","other_id":"11-007970","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":4,"maximum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subject is aged 4 to 18 years of age\r\n\r\n          -  Subjects will be having a peripheral IV line placed at the discretion of the treating\r\n             physician for usual care of presenting complaints.\r\n\r\n          -  Physician in charge of the subject is willing to wait the 30 minutes needed for the\r\n             study preparation\r\n\r\n          -  Subject/caregiver understands English\r\n\r\n          -  Parent or legal guardian has signed Institutional Review Board (IRB) approved informed\r\n             consent and subject (if age 7 years or older) has given assent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subject is critically ill with a triage category of 1\r\n\r\n          -  Subject has a condition that precludes the use of the self-report pain scale\r\n\r\n          -  Subject has an abrasion, infection or break in skin in the area where Buzzy would be\r\n             placed\r\n\r\n          -  Nerve damage is present in the extremity for planned IV placement\r\n      ","sponsor":"Children's Hospital of Philadelphia","sponsor_type":"Other","conditions":"Pain|Anxiety","interventions":[{"intervention_type":"Device","name":"Device: Buzzy","description":"Cold, Vibrational Device"},{"intervention_type":"Drug","name":"Drug: Topical Lidocaine 4% Cream","description":"Applied to anticipated IV site at least 30 minutes prior to cannulation."}],"outcomes":[{"outcome_type":"primary","measure":"Change From Baseline in Faces Pain Scale Revised (FPS-R) at 30 Minutes After IV Cannulation","time_frame":"Baseline and 30 minutes","description":"The Faces Pain Scale Revised (FPS-R) is numerical self-report measure of pain intensity developed for children to score the sensation of pain from 0-10. Pictures of 6 cartoon faces ranging from neutral expression of \"no pain\" (0) to \"very much pain\" (10)."},{"outcome_type":"secondary","measure":"Comparison of the Face, Legs, Activity, Cry, Consolability Scale (FLACC) Score Immediately After IV Cannulation Between Groups","time_frame":"Up to 5 minutes after IV Cannulation","description":"The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. The FLACC score was completed immediately after IV cannulation by a member of the clinical care team who was not part of the study. During initial trial design, the goal was to collect FLACC score pre and post cannulation; however, it was decided prior to enrollment that FLACC score would not be collected pre cannulation, only post."}]}
{"nct_id":"NCT01153984","start_date":"2011-06-30","phase":"Phase 2","enrollment":23,"brief_title":"A Study to Assess Biomarkers Impact on Participants Response to Erlotinib Treatment for First-line Non-Small Cell Lung Cancer With Endothelial Growth Factor Receptor (EGFR) Activating Mutations","official_title":"Biomarkers Impact on the Response to Treatment With Erlotinib in First Line Non-small Cell Lung Cancer With EGFR Activating Mutations - BIOTEC","primary_completion_date":"2015-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-07-31","last_update":"2017-04-13","description":"This open-label, single-arm, multi-center study will evaluate the progression-free survival in participants with histologically documented, advanced and/or metastatic chemotherapy naive, non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) positive mutations and receiving erlotinib treatment. The anticipated time on study treatment is until disease progression, unacceptable toxicity, withdrawal due to any reason or death.","other_id":"ML22606","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histological documented adenocarcinoma, locally advanced - Stage IIIB, metastatic -\r\n             Stage IV or recurrent non-squamous NSCLC\r\n\r\n          -  Activated EGFR mutation positive status (Exons 19 and 21) for treatment phase\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1\r\n\r\n          -  Life expectancy greater than or equal to () 12 weeks\r\n\r\n          -  Evidence of disease with at least one measurable disease evaluation on Response\r\n             Evaluation Criteria in Solid Tumors (RECIST)\r\n\r\n          -  Adequate hematological , liver and renal function\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Known hypersensitivity to erlotinib or any of its excipients\r\n\r\n          -  Squamous non-small cell or small cell tumors or absence of histological report\r\n\r\n          -  Neoadjuvant/adjuvant chemotherapy within 6 months prior to enrollment\r\n\r\n          -  Prior exposure to inhibitors of EGFR\r\n\r\n          -  Prior chemotherapy or treatment with another systemic anti-cancer agent for the\r\n             treatment of the participant's current stage of disease\r\n\r\n          -  Any significant ophthalmologic abnormality, especially severe dry eye syndrome,\r\n             keratoconjunctivitis sicca, Sjgren syndrome, severe exposure keratitis or any other\r\n             disorder likely to increase the risk of corneal epithelial lesions\r\n\r\n          -  Radical radiotherapy with curative intent within 28 days prior to enrollment\r\n\r\n          -  Any active non-controlled systemic disease\r\n      ","sponsor":"Hoffmann-La Roche","sponsor_type":"Industry","conditions":"CarcinomaNon-Small-Cell Lung","interventions":[{"intervention_type":"Drug","name":"Drug: Erlotinib","description":"Erlotinib 150 mg oral doses will be administered daily."}],"outcomes":[{"outcome_type":"primary","measure":"Progression-Free Survival (PFS), as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)","time_frame":"Baseline up to approximately 4 years","description":"PFS was the time from inclusion in the study to the date of first documented PD or death from any cause, whichever occurred first. Participants without event were censored at the date of the last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of disease progression, the participant was censored at the date of last tumor assessment before starting new chemotherapy. Analysis was performed using Kaplan-Meier method. PD was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions."},{"outcome_type":"secondary","measure":"Time to Disease Progression, as Assessed by Investigator Using RECIST v1.1","time_frame":"Baseline up to approximately 4 years","description":"Time to disease progression was defined as the time from baseline evaluation to the first date PD was recorded. Participants without progression were censored at the date of last tumor assessment where non-progression was documented. PD was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions."},{"outcome_type":"secondary","measure":"Percentage of Participants With Complete Response (CR) And Partial Response (PR) as Assessed by the Investigator Using RECIST v1.1","time_frame":"Baseline up to approximately 4 years","description":"CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter compared to baseline."},{"outcome_type":"secondary","measure":"Percentage of Participants Who Were Alive One Year After Study Treatment Initiation","time_frame":"Year 1"},{"outcome_type":"secondary","measure":"Percentage of Participants by Localization of PD, as Assessed by Investigator Using RECIST v1.1","time_frame":"Baseline up to approximately 4 years","description":"PD was assessed using RECIST v1.1. PD was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. Percentage of participants by localization of PD were reported. Localization included: Left lung inferior lobe; Para-aortic; Left lung upper lobe; Right lung inferior lobe; and Infracranial."},{"outcome_type":"secondary","measure":"Number of EGFR Positive Participants Classified Based on Smoking Status","time_frame":"Day 1","description":"Participants were asked: \"Have you smoked at least 100 cigarettes in your entire life?\" and \"Do you now smoke cigarettes every day, some days, or not at all?\" Responses were grouped into three categories: Current Smoker, Former Smoker, and Non-Smoker. Participants who reported smoking at least 100 cigarettes in their lifetime and who, at the time of survey, smoked either every day or some days were defined as 'Current smoker'. Participants who reported smoking at least 100 cigarettes in their lifetime and who, at the time of the survey, did not smoke at all were defined as 'Former smoker'. Participants who reported never having smoked 100 cigarettes were defined as 'Non-smoker'."},{"outcome_type":"secondary","measure":"Number of EGFR Positive Participants Classified Based on Type of EGFR Mutations","time_frame":"Day 1","description":"Participants with NSCLC have tumor associated with EGFR mutations. These mutations occur within EGFR Exons 18-21, which encodes a portion of the EGFR kinase domain."},{"outcome_type":"secondary","measure":"Percentage of Similar EGFR Mutations Between Matched Plasma and Tumor Tissue Samples","time_frame":"Baseline up to approximately 4 years"}]}
{"nct_id":"NCT01345539","start_date":"2011-06-30","phase":"Phase 2","enrollment":44,"brief_title":"Radiosurgery for Patients With Oligometastatic Disease at Initial Presentation","official_title":"Phase II Study for Curative Intent Treatment for Patients With Oligometastatic Disease at Initial Presentation (UPCI #10-027)","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2024-02-29","last_update":"2020-08-27","description":"The purpose of this study is to evaluate feasibility of radiosurgery for all metastatic sites for patients presenting with oligometastatic disease.","other_id":"10-027","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Pathologically (histologically or cytologically) proven diagnosis of solid malignancy\r\n             within 8 weeks of registration\r\n\r\n          2. Eligible disease sites include the following\r\n\r\n               -  Breast\r\n\r\n               -  Prostate\r\n\r\n               -  GI (including colorectal, anal, esophagus, pancreas, gastric with the exception\r\n                  of colon cancer with resectable liver-only lesions)\r\n\r\n               -  Head and neck\r\n\r\n               -  Skin (melanoma and squamous cell carcinoma)\r\n\r\n               -  Lung (both small cell and non-small cell)\r\n\r\n               -  Sarcoma (both soft tissue and bone)\r\n\r\n               -  Gynecologic (endometrial, cervical, ovarian, vaginal, vulvar)\r\n\r\n          3. Patients are stage IV (M1) with any combination of T and N with oligometastatic\r\n             disease as defined by 5 or fewer total sites of metastatic disease involving 3 or\r\n             fewer organ systems\r\n\r\n        1 Examples of patients eligible for trial\r\n\r\n          -  T3N2M1 NSCLC with 1 CNS metastatic lesion, 2 liver lesions, and 1 adrenal lesion.\r\n\r\n          -  T4N1M1 colorectal cancer with 1 liver lesion, 4 bone lesions\r\n\r\n          -  T3N0M1 gastric cancer with 1 supraclavicular lymph node, 2 liver lesions, and 2 CNS\r\n             lesions 4Metastatic disease sites must be treatable with SRS (at discretion of\r\n             treating physician).\r\n\r\n             5Primary disease site must be able to be treated with curative intent 6Zubrod\r\n             Performance Status 0-1 7Age  18 8CBC/differential obtained within 4 weeks prior to\r\n             registration on study, with adequate bone marrow function defined as follows:\r\n\r\n          -  Absolute neutrophil count (ANC)  1,800 cells/mm3;\r\n\r\n          -  Platelets  100,000 cells/mm3;\r\n\r\n          -  Hemoglobin  8.0 g/dl (Note: The use of transfusion or other intervention to achieve\r\n             Hgb  8.0 g/dl is acceptable.); 9Women of childbearing potential and male participants\r\n             must practice adequate contraception 10Patient must provide study specific informed\r\n             consent prior to study entry.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Ineligible disease sites include the following\r\n\r\n               -  Lymphoma\r\n\r\n               -  Leukemia\r\n\r\n               -  Multiple myeloma\r\n\r\n               -  Primary CNS\r\n\r\n               -  Peritoneal carcinomatosis\r\n\r\n               -  Colon cancer with resectable liver-only lesions\r\n\r\n          2. Examples of patients ineligible for trial\r\n\r\n               -  T1N1M1 NSCLC with 1 CNS lesion, 1 bone lesion, 1 adrenal lesion and a cervical\r\n                  lymph node (4 sites of metastatic disease)\r\n\r\n               -  T2N1M1 Gastric cancer with 6 liver lesions (more than 5 sites of metastatic\r\n                  disease)\r\n\r\n          3. Other\r\n\r\n               -  Lung cancer with pleural effusion (wet IIIB) are not eligible\r\n\r\n               -  Recurrent cancers are not eligible\r\n\r\n               -  Diffuse metastatic spread confined to one organ system is ineligible; examples of\r\n                  this include leptomeningeal spread in the CNS and peritoneal carcinomatosis.\r\n\r\n          4. Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a\r\n             different cancer is allowable but cannot have any other primary cancer diagnosed or\r\n             treated within the last 3 years other than cutaneous skin cancers. Patient may have\r\n             previous chemotherapy as treatment of this previous malignancy as long as the\r\n             chemotherapy has completed more than 3 years ago.\r\n\r\n          5. Prior radiotherapy to the region of the study cancer that would result in overlap of\r\n             radiation therapy fields\r\n\r\n          6. Severe, active co-morbidity, defined as follows:\r\n\r\n               -  Unstable angina and/or congestive heart failure requiring hospitalization within\r\n                  the last 6 months;\r\n\r\n               -  Transmural myocardial infarction within the last 6 months;\r\n\r\n               -  Acute bacterial or fungal infection requiring intravenous antibiotics at the time\r\n                  of registration;\r\n\r\n               -  Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects;\r\n                  note, however, that laboratory tests for liver function and coagulation\r\n                  parameters are not required for entry into this protocol.\r\n\r\n               -  Immuno-compromised patients.\r\n\r\n          7. Pregnancy or women of childbearing potential and men who are sexually active and not\r\n             willing/able to use medically acceptable forms of contraception; this exclusion is\r\n             necessary because the treatment involved in this study may be significantly\r\n             teratogenic.\r\n\r\n          8. Oligometastatic disease sites not eligible based on concern for toxicity:\r\n\r\n               -  trachea involvement (direct invasion, tumors close to or abutting trachea are\r\n                  eligible)\r\n\r\n               -  heart (direct invasion or involvement, pericardial lymph nodes can be treated)\r\n\r\n          9. Patients unable to have an FDG-PET/CT scan, either through insurance coverage, patient\r\n             decision or other reason are not eligible for this study.\r\n\r\n         10. Patients unable to have SRS through insurance coverage or ability to pay for SRS\r\n      ","sponsor":"Steven Burton","sponsor_type":"Other","conditions":"Oligometastatic Disease","interventions":[{"intervention_type":"Radiation","name":"Radiation: Stereotactic Radiosurgery (SRS)","description":"Dose and fractionation will be dependent on the lesion location and lesion size, the exact fractionation and dose is at the discretion of the treating physician. A minimum of 48 hours must be used in between SRS treatments at each site. Note that patients can have SRS everyday or multiple SRS sessions in one day as long as the minimum time for each treatment site is met. For example, if two lung lesions, adrenal, and liver sites were being treated, both lung sites could be treated Monday, Wednesday, and Friday, the liver on Tuesday, Thursday and the following Tuesday, and the adrenal on Monday, Wednesday, Friday of the second week."}],"outcomes":[{"outcome_type":"primary","measure":"Feasibility of SRS/SBRT in patients with metastatic disease at initial presentation","time_frame":"3 Years","description":"Being able to complete accrual to study"},{"outcome_type":"secondary","measure":"Quality of life (as measured by FACT surveys)","time_frame":"5 years","description":"Report changes in QOL scores over time. QOL scores before and after treatment will be compared using univarite and multivariate analysis. QOL will be recored as 'improved' or 'non-improved'"},{"outcome_type":"secondary","measure":"Local control of metastatic sites","time_frame":"5 years","description":"CR, PR, PD of treated sites as measured according to RECIST criteria"},{"outcome_type":"secondary","measure":"Local control of primary site","time_frame":"5 years","description":"CR, PR, PD of treated sites as measured according to RECIST criteria"},{"outcome_type":"secondary","measure":"Overall survival","time_frame":"5 years","description":"Survival rate will be calculated for all the patients and each patient subset respectively by using Kaplan-Meier survival analyses, with survival and event times defined from the day of enrollment until either an event or last follow-up. We can compare these two year survival rates with those from the patients using traditional therapy."},{"outcome_type":"secondary","measure":"Analysis of patterns of failure post-SRS","time_frame":"5 years","description":"Descriptive analysis of location and timing of disease recurrenc. We will also report the entire patient characteristics at initial presentation of oligometastatic disease and characteristics of Long-term (>=2 years) survivors by using descriptive statistics. SAS software will be used for all the data analysis"}]}
{"nct_id":"NCT01595282","start_date":"2011-06-30","phase":"N/A","enrollment":94,"brief_title":"Intramuscular Ketorolac Versus Oral Ibuprofen for Pain Relief in First Trimester Suction Curettage","official_title":"Intramuscular Ketorolac Versus Oral Ibuprofen for Pain Relief in First Trimester Suction Curettage: a Randomized Clinical Trial.","primary_completion_date":"2012-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-06-30","last_update":"2014-07-02","description":"The aim of this study is to compare the effect of pre-procedural ketorolac to ibuprofen on immediate post-procedural pain scores in patients undergoing first trimester suction curettage with local anesthesia only. Our primary hypothesis is that IM ketorolac compared to oral ibuprofen will result in an approximate 30% reduction in pain scores on a 21-point numerical rating scale immediately after the procedure. Secondary hypotheses include: - Pain scores on the 21-point scale will also be significantly lower in the ketorolac group immediately after cervical dilation and 15 minutes post-procedure. - Fewer patients in the ketorolac group will rate their pain as \"severe\" on a subjective pain rating scale. - Patients in the ketorolac group will be more satisfied with their pain control. - Side effects will be similar between groups.","other_id":"2011-p-000259","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Women age 18 or older seeking suction curettage at Planned Parenthood League of\r\n             Massachusetts (PPLM)\r\n\r\n          -  Gestational age less than or equal to 11+6, confirmed by ultrasound\r\n\r\n          -  Eligible for suction curettage according to PPLM protocols\r\n\r\n          -  Choice of local anesthesia\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Choice of IV sedation for pain control\r\n\r\n          -  Hypersensitivity to NSAIDs or lidocaine\r\n\r\n          -  Contraindications to NSAIDs:\r\n\r\n        Active renal disease Active hepatic disease Gastric ulcer disease or gastritis Long-term\r\n        NSAID or aspirin use Bleeding disorder\r\n\r\n          -  NSAIDs taken < 8 hours prior to procedure\r\n\r\n          -  Need for cervical ripening with either misoprostol or mechanical priming agent\r\n             (laminaria/Dilapan)\r\n\r\n          -  Long-term narcotic use\r\n\r\n          -  Unable or unwilling to complete required study procedures\r\n\r\n          -  Previous participation in the study\r\n      ","sponsor":"Planned Parenthood League of Massachusetts","sponsor_type":"Other","conditions":"Pain","interventions":[{"intervention_type":"Drug","name":"Drug: Ketorolac","description":"For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure"},{"intervention_type":"Drug","name":"Drug: Ibuprofen","description":"For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure."}],"outcomes":[{"outcome_type":"primary","measure":"Immediate Post-procedure Pain Score","time_frame":"Immediately (within 1 minute) after suction and speculum removal","description":"The primary endpoint is subjects' immediate post-procedure pain score on a 21-point 0 to 100 scale, 0 = no pain and 100 = worst possible pain (in increments of five). This scale has been previously validated and used for research purposes, including for pain research evaluating suction curettage elsewhere and at our institution (Jensen 1986, Williamson 2004, Allen 2009)."},{"outcome_type":"secondary","measure":"Pain Scores Immediately After Cervical Dilation","time_frame":"Immediately (within 1 minute) after cervical dilation prior to the introduction of the suction cannula","description":"21-point 0 to 100 scale where 0 = no pain and 100 = worst possible pain (in increments of five)"},{"outcome_type":"secondary","measure":"Pain Scores 15 Minutes Post-procedure","time_frame":"Fifteen minutes after the procedure","description":"21-point 0 to 100 scale, where 0 = no pain and 100 = worst possible pain (in increments of five)"}]}
{"nct_id":"NCT01755611","start_date":"2011-06-17","phase":"Phase 1","enrollment":25,"brief_title":"Bioequivalence Minocycline Bioequivalence","official_title":"Bioequivalence Study Between Two Medications for Oral Administration of Minocycline in 100 mg Oral Solids in Healthy Volunteers","primary_completion_date":"2011-06-25","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-06-25","last_update":"2017-06-22","description":"The aim of the study is to compare the bioavailability of two medications containing 100 mg of minocycline in capsules to determine bioequivalence. They are Minocycline (Minocin is a registered trademark of Wyeth Holdings Corporation), and Minocycline (Minopac is a registered trademark of LABORATORIOS DERMATOLOGICOS DARIER, S.A. DE C.V.). Study design is randomized, open, cross-over with two single administrations with two periods and two sequences with a wash-out period of 7 days between the periods. Subjects in the study will be 25 healthy male volunteers, 18-55 years, Blood samples will be obtained at 0.0, 0.33, 0.66, 1.0, 1.33, 1.66, 2.0, 2.33, 2.66, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 48.0, and 72.0 hours after medication administration in each period. Plasma minocycline levels will be determined by HPLC method with UV detection with previously validated method. Minocycline concentration data will be used to calculate Cmax, AUC0-t, and AUC0-inf with WinNonlin 5.3 software. The log transformed pharmacokinetics parameters of test and reference medications will be compared calculating ratios and 90% confidence intervals. Any adverse event will be reported.","other_id":"116745","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Males 18-55 years. Healthy based on comprehensive medical history, lab tests, Chest x-ray,\r\n        Electrocardiogram, negative tests for Hepatitis B and C, and HIV. Negative urine doping\r\n        test. BMI 19-26.5 kg/m2. Lab test in normal range +/- 10%. Blood pressure 139-90/89-50,\r\n        heart rate 100-55, respiratory rate 24-17, temperature 37.5-35 C. Non-smoking at least for\r\n        10 hrs before study. Written informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Hypersensitivity to study medication or other related drug. History of cardiovascular,\r\n        renal, hepatic, metabolic, gastrointestinal, neurologic, endocrine, hematopoietic,\r\n        psychiatric or organic condition.\r\n\r\n        Requiring any drug interfering with minocycline pharmacokinetics. Exposed to inducers or\r\n        inhibitors of hepatic enzymes. Intake of possible toxic drugs 30 days before study. Intake\r\n        of any drug 14 days or 7 half-lives before study. Hospitalization or severe disease 60 days\r\n        before study. Receiving investigational drug out of study center 30 days before study.\r\n        Blood loss or blood donation  450 ml 60 days before study. Recent history of drug abuse\r\n        including alcohol. Intake of xanthine containing products 10 hrs before study. Intake of\r\n        grapefruit juice or hot-spice 10 hrs before study.\r\n      ","sponsor":"GlaxoSmithKline","sponsor_type":"Industry","conditions":"Skin Infections (Acne)","interventions":[{"intervention_type":"Drug","name":"Drug: Minocycline 100mg","description":"Test product"},{"intervention_type":"Drug","name":"Drug: Minocycline 100mg","description":"Reference product"}],"outcomes":[{"outcome_type":"primary","measure":"Peak Plasma Concentration (CMAX) of drug minocycline","time_frame":"0.0, 0.33, 0.66, 1.0, 1.33, 1.66, 2.0, 2.33, 2.66, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 48.0, and 72.0 hours postdose","description":"Pharmacokinetics"},{"outcome_type":"primary","measure":"Area under the plasma concentration versus time curve (AUC) of drug minocycline","time_frame":"0.0, 0.33, 0.66, 1.0, 1.33, 1.66, 2.0, 2.33, 2.66, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 48.0, and 72.0 hours postdose","description":"Pharmacokinetics"}]}
{"nct_id":"NCT01272232","start_date":"2011-06-01","phase":"Phase 3","enrollment":846,"brief_title":"Effect of Liraglutide on Body Weight in Overweight or Obese Subjects With Type 2 Diabetes: SCALE - Diabetes","official_title":"Effect of Liraglutide on Body Weight in Overweight or Obese Subjects With Type 2 Diabetes: A 56 Week Randomised, Double-blind, Placebo-controlled, Three Armed Parallel Group, Multi-centre, Multinational Trial With a 12 Week Observational Follow-up Period","primary_completion_date":"2013-01-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-01-25","last_update":"2017-12-29","description":"This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim of this trial is to investigate the potential of liraglutide to induce and maintain weight loss in overweight or obese subjects with type 2 diabetes. Treatment will be added onto subject's pre-trial background diabetes treatment of either diet and exercise only or single compound oral antidiabetic drug (OAD) treatment (metformin, sulphonylurea [SU] or glitazone) or combination OAD treatment (metformin, sulphonylurea or glitazone). The duration of the trial will be 56 weeks followed by a 12 week observational follow-up period.","other_id":"NN8022-1922","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Informed consent obtained\r\n\r\n          -  Subjects diagnosed with type 2 diabetes and treated with either diet and exercise\r\n             alone, metformin, sulphonylurea, glitazone as single agent therapy or a combination of\r\n             the previously mentioned compounds\r\n\r\n          -  HbA1c 7.0-10.0% (both inclusive)\r\n\r\n          -  Body Mass Index (BMI) at least 27.0 kg/m^2\r\n\r\n          -  Stable body weight\r\n\r\n          -  Preceding failed dietary effort\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, dipeptidyl\r\n             peptidase-4 (DPP-4) inhibitors or insulin within the last 3 months\r\n\r\n          -  Known proliferative retinopathy or maculopathy\r\n\r\n          -  History of acute or chronic pancreatitis\r\n\r\n          -  Obesity induced by drug treatment\r\n\r\n          -  Use of approved weight lowering pharmacotherapy\r\n\r\n          -  Previous surgical treatment of obesity\r\n\r\n          -  History of major depressive disorder or suicide attempt\r\n\r\n          -  Uncontrolled hypertension (systolic blood pressure above or equal to 160 mmHg and/or\r\n             diastolic blood pressure above or equal to 100 mmHg)\r\n\r\n          -  Screening calcitonin of 50 ng/L or above\r\n\r\n          -  Familial or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial\r\n             medullary thyroid carcinoma (FMTC)\r\n\r\n          -  Personal history of non-familial medullary thyroid carcinoma\r\n      ","sponsor":"Novo Nordisk A/S","sponsor_type":"Industry","conditions":"Metabolism and Nutrition Disorder|Obesity","interventions":[{"intervention_type":"Drug","name":"Drug: liraglutide","description":"Liraglutide 3.0 mg for subcutaneous (under the skin) injection once daily for 56 weeks."},{"intervention_type":"Drug","name":"Drug: liraglutide","description":"Liraglutide 1.8 mg for subcutaneous (under the skin) injection once daily for 56 weeks."},{"intervention_type":"Drug","name":"Drug: placebo","description":"Liraglutide placebo of either 3.0 mg or 1.8 mg for subcutaneous (under the skin) injection once daily for 56 weeks."}],"outcomes":[{"outcome_type":"primary","measure":"Change (%) From Baseline in Body Weight (Fasting)","time_frame":"Week 0, week 56","description":"Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial."},{"outcome_type":"primary","measure":"Proportion of Subjects Losing at Least 5% of Baseline Body Weight","time_frame":"at 56 weeks","description":"Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial."},{"outcome_type":"primary","measure":"Proportion of Subjects Losing More Than 10% of Baseline Body Weight","time_frame":"at 56 weeks","description":"Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial."},{"outcome_type":"secondary","measure":"Change (%-Points) From Baseline in HbA1c (Glycosylated Haemoglobin A1c)","time_frame":"Week 0, week 56","description":"Change in HbA1c (%-points) was calculated as the difference between the HbA1c (%) at Week 0 and Week 56."},{"outcome_type":"secondary","measure":"Proportion of Subjects Reaching Target HbA1c Below 7%","time_frame":"at 56 weeks"},{"outcome_type":"secondary","measure":"Proportion of Subjects Reaching Target HbA1c Below or Equal to 6.5%","time_frame":"at 56 weeks"},{"outcome_type":"secondary","measure":"Change From Baseline in Waist Circumference","time_frame":"Week 0, week 56"},{"outcome_type":"secondary","measure":"Change (%) From Baseline in Body Weight (Fasting)","time_frame":"Week 0, week 68","description":"Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial."},{"outcome_type":"secondary","measure":"Change (%) From Week 56 to 68 in Body Weight (Fasting)","time_frame":"Week 56, week 68","description":"Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial."},{"outcome_type":"secondary","measure":"Change From Baseline in Waist Circumference","time_frame":"Week 0, week 68"},{"outcome_type":"secondary","measure":"Change From Week 56 to 68 in Waist Circumference","time_frame":"Week 56, week 68"},{"outcome_type":"secondary","measure":"Incidence of Hypoglycaemic Episodes","time_frame":"Weeks 0-56","description":"Hypoglycaemic episodes were classified according to American Diabetes Association (ADA) definitions as well as to the Novo Nordisk definition of a minor hypoglycaemic event (blood glucose level below approximately 2.8 mmol/L [50 mg/dL] or plasma glucose level below 3.1 mmol/L [56 mg/dL])."}]}
{"nct_id":"NCT01327911","start_date":"2011-05-31","phase":"Phase 1","enrollment":7,"brief_title":"Ciliary Neurotrophic Factor (CNTF) Safety Trial in Patients With Macular Telangiectasia (Mactel)","official_title":"A Phase 1 Multicenter Open Label Safety and Tolerability Clinical Trial of Ciliary Neurotrophic Factor (CNTF) in Patients With Macular Telangiectasia Type 2 (Mactel)","primary_completion_date":"2016-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-09-30","last_update":"2016-11-22","description":"This study is a phase 1, open label, non-randomized, multi-center, pilot study to evaluate the safety and tolerability of NT-501 implants in 5-7 study participants with Mactel.","other_id":"NTMT-01","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":21,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  The participant must be offered sufficient opportunity to review the informed consent\r\n             form, agree to the form's contents and sign the protocol's informed consent;\r\n\r\n          -  The participant must have bilateral MacTel;\r\n\r\n          -  Women of childbearing potential and all men must agree to use an effective form of\r\n             birth control during the study;\r\n\r\n          -  Participant must be medically able to undergo ophthalmic surgery for ECT implant;\r\n\r\n          -  The participant's best-corrected visual acuity 64 letters or better (20/50 or better)\r\n             in the study eye;\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Participant is < 21 years of age;\r\n\r\n          -  Participant is medically unable to comply with study procedures or follow- up visits;\r\n\r\n          -  Participant has evidence of ocular disease other than MacTel that may confound the\r\n             outcome of the study (e.g., diabetic retinopathy with manifest macular edema, uveitis,\r\n             etc.);\r\n\r\n          -  Participant has a chronic requirement (e.g.,  4 weeks at a time) for ocular\r\n             medications and/or has a diagnosed disease, that in the judgment of the examining\r\n             physician, may be vision threatening or may affect the primary outcome (artificial\r\n             tears are permitted);\r\n\r\n          -  Participant has evidence of subretinal neovascularization in either eye;\r\n\r\n          -  Participant has evidence of central serous chorio-retinopathy (CSR) in either eye;\r\n\r\n          -  Participant has evidence of pathologic myopia in either eye;\r\n\r\n          -  Participant has had a vitrectomy, penetrating keratoplasty, trabeculectomy or\r\n             trabeculoplasty;\r\n      ","sponsor":"Neurotech Pharmaceuticals","sponsor_type":"Industry","conditions":"Idiopathic Juxtafoveal Telangiectasia","interventions":[{"intervention_type":"Biological","name":"Biological: NT-501 implant","description":"Ciliary neurotrophic factor (CNTF) implant"}],"outcomes":[{"outcome_type":"primary","measure":"Visual Acuity","time_frame":"3,12, 24 and 36 months","description":"Visual acuity decrease of >=15 letters"},{"outcome_type":"secondary","measure":"Microperimetry","time_frame":"12, 24 and 36 months","description":"Change of a 10dB at least one point either adjacent to a pre-existing scotoma or in a new area within the central 10 degrees on microperimetric testing"},{"outcome_type":"secondary","measure":"OCT","time_frame":"12, 24, and 36 months","description":"Change in en face area as measured by OCT"}]}
{"nct_id":"NCT01368575","start_date":"2011-05-31","phase":"Phase 4","enrollment":420,"brief_title":"Surgical Treatment of Ischemic Mitral Regurgitation","official_title":"The Effect of Different Surgical Methods in the Treatment of Patients With Ischemic Mitral Regurgitation and Assess the Dynamics of Heart Failure and the Effectiveness of Surgical Treatment of Mitral Valve.","primary_completion_date":"2014-05-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2015-11-30","last_update":"2015-09-23","description":"The primary objective is to estimate surgical treatment (prosthesis or plastic) of moderate and severe ischemic mitral regurgitation combined with CABG in patients with CAD and impact on heart failure and progress of mitral regurgitation.","other_id":"TIME-002","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":30,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patient is a male or female between 30 to 75 years of age (inclusive) on the day of\r\n             signing the informed consent.\r\n\r\n          -  Patients with a verified diagnosis of CAD, including post myocardial infarction scar.\r\n\r\n          -  Coronary artery pathology to be coronary artery bypasses grafting.\r\n\r\n          -  The presence of moderate or severe ischemic mitral regurgitation.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  The patient did not sign the informed consent.\r\n\r\n          -  Aortic valve disease requiring prosthetic or aortic valve repair.\r\n\r\n          -  Organic lesion of valve and subvalvular structures (endocarditis and degenerative\r\n             processes of the mitral valve).\r\n\r\n             ) separation of the mitral valve chords; ) rupture and perforation of the mitral\r\n             valve; ) myxomatous degeneration and calcification of the mitral valve\r\n\r\n          -  Patients with acute coronary syndrome.\r\n\r\n          -  The presence of the indications for angioplasty of the coronary arteries.\r\n\r\n          -  Coronary artery bypasses grafting in history.\r\n\r\n          -  Parallel patient participation in other studies.\r\n\r\n          -  The organs diseases, which can be reason to death after surgery during the first 3\r\n             years.\r\n      ","sponsor":"Meshalkin Research Institute of Pathology of Circulation","sponsor_type":"Other","conditions":"Mitral Valve Insufficiency","interventions":[{"intervention_type":"Procedure","name":"Procedure: CABG","description":"CABG"},{"intervention_type":"Procedure","name":"Procedure: CABG combined with MV repair with remodeling annuloplasty rigid ring","description":"CABG combined with MV repair with remodeling annuloplasty rigid ring"},{"intervention_type":"Procedure","name":"Procedure: CABG combined with MV repair with remodeling annuloplasty rigid ring","description":"CABG combined with MV repair with remodeling annuloplasty rigid ring"},{"intervention_type":"Procedure","name":"Procedure: CABG combined with MV repair with remodeling annuloplasty rigid ring and endoventricularplasty of subvalvular apparatus","description":"CABG combined with MV repair with remodeling annuloplasty"},{"intervention_type":"Procedure","name":"Procedure: CABG and MV replacement","description":"coronary artery bypass grafting and mitral valve replacement"}],"outcomes":[{"outcome_type":"primary","measure":"Assess the degree of mitral regurgitation in the early and late term of the study. Identify the cause of the return of IMR. Determine the dynamics of heart failure in patients with IMR.","time_frame":"3,6,12,24,36 months"},{"outcome_type":"secondary","measure":"Assessment of IMR","time_frame":"3 years"}]}
{"nct_id":"NCT01295762","start_date":"2011-05-31","phase":"N/A","enrollment":35,"brief_title":"Immunomonitoring of Children With Neuroblastoma","official_title":"Immunomonitoring of Children With Neuroblastoma for the Development of Antitumor Immunotherapy Strategies","primary_completion_date":"2019-03-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-07-31","last_update":"2018-08-23","description":"Apart from brain tumors, Neuroblastoma is the most common solid tumor during childhood. About 50% of the cases present at diagnosis with factors of bad prognosis. During the last two decades, despite increased therapeutic intensity during induction and consolidation of high-risk neuroblastomas, the 5 year overall survival of high risk neuroblastoma remains in between 30 to 40% depending on studies. Besides strategies of high-dose chemotherapy followed by autologous transplantation of hematopoietic stem cells, and differentiating molecules (retinoids), immunotherapy will become one of the leading anti-neuroblastoma targeted therapy. No therapeutic strategies or molecules obtained such gains of survival ever before. Studying the immune system of children with neuroblastoma at diagnosis and during their treatment will help us to determine when we should test active or passive immunotherapy strategies. Moreover, this study would allow us to specify the cause of tumor immune tolerance in neuroblastoma, on which we have few data in comparison to adult tumors. This will be a multicentric, pilot, prospective, open, study that will not require unusual diagnostic interventions. This study will be transversal (all neuroblastoma stages included) in order to determine comparative criteria between low and high risk neuroblastoma. It will also be longitudinal (from diagnosis to post-treatment follow-up) in order to specify evolutionary aspects of immunity under radio-chemotherapy and retinoic acid therapy. Immunological analyses will be done on blood, bone marrow and tumor samples, at diagnosis, and during the treatment of children diagnosed for neuroblastoma (up to 3 time points). These types of samples are routinely done during conventional neuroblastoma treatment.","other_id":"IMMUNEURO","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Screening","masking_description":"None (Open Label)","sampling_method":"","gender":"All","maximum_age":21,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age <= 21 years\r\n\r\n          -  Patient with neuroblastoma any stage, in the first line or relapsed, or suspicion of\r\n             neuroblastoma\r\n\r\n          -  Covered by a medical insurance\r\n\r\n          -  Written, signed informed consent (patient, and parents if minor child)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who received corticosteroids within 15 days prior to sampling\r\n\r\n          -  Patients receiving immunosuppressive therapy\r\n\r\n          -  Chemotherapy before sampling began\r\n\r\n          -  Neuroblastoma in a genetic syndrome predisposing\r\n\r\n          -  Deterioration of clinical status\r\n      ","sponsor":"Centre Leon Berard","sponsor_type":"Other","conditions":"Neuroblastoma","interventions":[{"intervention_type":"Other","name":"Other: Immunological analyses","description":"Immunological analyses will be done on blood, bone marrow and tumor samples, at diagnosis, and during the treatment of children diagnosed for neuroblastoma (up to 3 time points). These types of samples are routinely done during conventional neuroblastoma treatment."}],"outcomes":[{"outcome_type":"primary","measure":"Description of immune effectors in the blood, marrow and tumor diagnosis.","time_frame":"1 year","description":"Rate effectors immunitaires in blood, marrow and tumor present at diagnosis"}]}
{"nct_id":"NCT01607619","start_date":"2011-05-31","phase":"N/A","enrollment":117,"brief_title":"Effect of Anatabine on Elevated Blood Levels of C-reactive Protein","official_title":"A 12-week Multi-site Trial of the Dietary Supplement Anatabine (RCP006) to Determine the Effects on Peripheral Markers of Inflammation in Patients With Elevated Levels of C-reactive Protein (CRP)","primary_completion_date":"2013-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-01-31","last_update":"2013-01-28","description":"The investigators are studying a dietary supplement called anatabine in a lozenge form named RCP006. The main purpose of this study is to evaluate the effects of this dietary supplement on normal human inflammatory function. The investigators will see this effect in volunteers who have markers of higher levels of inflammation to begin with. The investigators anticipate that anatabine will reduce markers of inflammation. Therefore the investigators are looking for volunteers with high blood levels of C-reactive Protein (CRP) and will monitor the blood CRP levels at several time points throughout the study.","other_id":"RI-11-01","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Supportive Care","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  healthy adults with elevated blood levels of hsCRP\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  pregnancy or planning pregnancy\r\n\r\n          -  current tobacco use\r\n\r\n          -  current steroid use\r\n\r\n          -  allergy to study product components\r\n      ","sponsor":"Roskamp Institute Inc.","sponsor_type":"Other","conditions":"Inflammation","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Anatabine","description":"1mg anatabine in a mint-flavored mannitol lozenge"}],"outcomes":[{"outcome_type":"primary","measure":"Blood levels of hsCRP","time_frame":"Days 1, 14, 42, 70"},{"outcome_type":"secondary","measure":"Blood levels of inflammatory markers","time_frame":"Days 1, 14, 42, 70"}]}
{"nct_id":"NCT01421836","start_date":"2011-05-31","phase":"Phase 2/Phase 3","enrollment":30,"brief_title":"Prospective Study Comparing EUS vs ERCP Stent Insertion for Malignant Biliary Obstruction","official_title":"Prospective Study Comparing EUS Guided Biliary Drainage and ERCP With Stent Placement for Malignant Biliary Obstruction","primary_completion_date":"2015-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-03-31","last_update":"2016-04-28","description":"1. Purpose of the study -To compare stent patency and complication rate between endoscopic ultrasound (EUS) guided stent insertion and endoscopic retrograde cholangiopancreatography (ERCP) guided stent insertion for malignant biliary obstruction 2. Subjects of the study -Patients who have biliary obstruction owing to malignant tumors 3. Methods of the study - Prospective randomized controlled study - Patients were enrolled randomly in two groups, EUS guided stent insertion group or ERCP guided stent insertion group - Patients will get assigned procedure (EUS guided stent insertion or ERCP guided stent insertion)for decompression of malignant biliary obstruction - After the procedure, regular follow up, blood test,and imaging test will be done to check sufficient biliary decompression,stent patency and complications.","other_id":"2011-03-101-001","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  distal biliary obstruction due to malignant tumor\r\n\r\n          -  unresectable tumor\r\n\r\n          -  Jaundice\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Children\r\n\r\n          -  Hilar obstruction\r\n\r\n          -  Active infection\r\n\r\n          -  Bleeding tendency\r\n      ","sponsor":"Samsung Medical Center","sponsor_type":"Other","conditions":"Tumor Appearance of Biliary System Obstruction","interventions":[{"intervention_type":"Procedure","name":"Procedure: ERCP-guided stent insertion","description":"ERCP guided stent insertion for malignant biliary obstruction"},{"intervention_type":"Procedure","name":"Procedure: EUS guided stent insertion","description":"EUS-guided stent insertion for malignant biliary obstruction"}],"outcomes":[{"outcome_type":"primary","measure":"stent patency (days)","time_frame":"six months"},{"outcome_type":"secondary","measure":"complication rate","time_frame":"six months"}]}
{"nct_id":"NCT01327183","start_date":"2011-05-31","phase":"Phase 2","enrollment":532,"brief_title":"A Study of RO4905417 in Patients With Non ST-Elevation Myocardial Infarction (Non-STEMI) Undergoing Percutaneous Coronary Intervention","official_title":"A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF 2 DOSES OF RO4905417 (R1512) ADMINISTERED TO PATIENTS WITH NON ST-ELEVATION MYOCARDIAL INFARCTION (NON-STEMI) UNDERGOING PERCUTANEOUS CORONARY INTERVENTION (PCI)","primary_completion_date":"2012-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-10-31","last_update":"2016-11-02","description":"This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of RO4905417 in patients with non ST-elevation myocardial infarction (Non-STEMI) undergoing percutaneous coronary intervention (PCI). Patients will be randomized to receive an intravenous infusion of either 5 mg/kg RO4905417 or 20 mg/kg RO4905417 or placebo before PCI. Follow-up will be for 4 months.","other_id":"BP25619","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":19,"maximum_age":74,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adult patients, >18 to <75 years of age\r\n\r\n          -  Non ST-elevation myocardial infarction\r\n\r\n          -  Woman of childbearing potential will be allowed only if using two acceptable methods\r\n             of contraception\r\n\r\n          -  Body mass index (BMI) <\/= 40 kg/m2\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Acute ST-elevation myocardial infarction (STEMI)\r\n\r\n          -  Culprit coronary lesion with a total thrombotic occlusion or a lesion requiring the\r\n             use of distal embolization protection or thrombectomy devices\r\n\r\n          -  Percutaneous coronary intervention (PCI) within the past 72 hours\r\n\r\n          -  Thrombolytic therapy within the past 7 days\r\n\r\n          -  Major surgery within the past 3 months\r\n\r\n          -  History of cerebral vascular disease or stroke in the past 3 months\r\n\r\n          -  Bleeding disorders\r\n\r\n          -  Inadequately controlled severe hypertension\r\n\r\n          -  Prior coronary artery bypass graft (CABG) surgery\r\n\r\n          -  Decompensated heart failure (oedema and/or rale)\r\n\r\n          -  Acute infection at screening or active chronic infection within 3 months prior to PCI\r\n\r\n          -  Patients known to be HIV positive, patients receiving antiretroviral drugs, or\r\n             immuno-suppressed patients\r\n\r\n          -  Uncontrolled diabetes mellitus (HbA1C >10%) at baseline\r\n      ","sponsor":"Hoffmann-La Roche","sponsor_type":"Industry","conditions":"Myocardial Infarction","interventions":[{"intervention_type":"Procedure","name":"Procedure: Percutaneous Coronary Intervention (PCI)","description":"at least 1 hour and up to 24 hours after completion of drug infusion"},{"intervention_type":"Drug","name":"Drug: RO4905417","description":"5 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI"},{"intervention_type":"Drug","name":"Drug: RO4905417","description":"20 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI"},{"intervention_type":"Drug","name":"Drug: placebo","description":"iv infusion, completed at least 1 hour and up to 24 hours before PCI"}],"outcomes":[{"outcome_type":"primary","measure":"Reduction of procedural damage during percutaneous coronary intervention (PCI): Change from baseline in troponin I levels early after PCI","time_frame":"from baseline to 24 hours post PCI"},{"outcome_type":"secondary","measure":"Change from baseline in troponin I at 8 hours post PCI","time_frame":"from baseline to 8 hours post PCI"},{"outcome_type":"secondary","measure":"Peak and AUC for troponin I","time_frame":"24 hours post PCI"},{"outcome_type":"secondary","measure":"Change from baseline in Creatine Kinase-Myocardial Band (CK-MB) after PCI","time_frame":"from baseline to 24 hours post PCI"},{"outcome_type":"secondary","measure":"Change form baseline in Growth Differentiation Factor 15 (GDF-15) at 120 days post PCI","time_frame":"from baseline to Day 120 post PCI"},{"outcome_type":"secondary","measure":"Change from baseline in cystatin C biomarker at 24 hours and 30 days post PCI","time_frame":"from baseline to Day 30 post PCI"},{"outcome_type":"secondary","measure":"Safety: Incidence of adverse events and major adverse cardiovascular events (MACEs)","time_frame":"120 days"}]}
{"nct_id":"NCT01406093","start_date":"2011-05-31","enrollment":400,"brief_title":"Early- and Late-onset Candidemia","official_title":"Early- and Late-onset Candidemia: A Retrospective Study","primary_completion_date":"2012-02-29","study_type":"Observational","rec_status":"Completed","completion_date":"2012-06-30","last_update":"2014-12-04","description":"A timing diagnosis of candidemia is as important as the correct choice of empiric or targeted antifungal therapy. In the last years a growing body of knowledge has better characterized health-care associated (HCA) infections, which have been described in 2002 in outpatients with MRSA bloodstream infections. So far there is no compelling evidence that patients with HCA infections may develop candidemia before the usual timing of around 20-25 days after admission. Risk factors associated with HCA infections are represented by admission from long term chronic care facilities (LTCF), haemodialysis, previous admission or parenteral broad spectrum antibiotics. There are few data HCA features and early onset candidemias in the published literature. In this proposal, the investigators aim at studying early-onset candidemia in a retrospective study in one of the largest referral hospital in Italy with a consistent range of specialties ranging (bone marrow transplant, solid organ transplant, immunosuppressed patients, ICU, complex surgery). The investigators speculate that patients with candidemia diagnosed within 10 days (early-onset) by the admission have different risk factors and prognosis of those with a late diagnosis.","other_id":"EOC1-11","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"The selection of patients for inclusion will be based on microbiological data (with\r\n        suscesptibilty patterns of the various antifungals) extracted from the computerized archive\r\n        with search for Candida spp. and \"blood\" either peripheral or from a central venous\r\n        catheter. Candida isolated from a removed CVC tip will not be considered. The candidemia\r\n        will also be defined early or late based on the time elapsed between hospital admission and\r\n        diagnosis ( 10 days early, > 10 days late candidemia).","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Candidemia diagnosed with positive blood culture either from a peripheral vein or CVC\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Candida isolated from a removed CVC tip will not be considered\r\n      ","sponsor":"Giovanni Di Perri","sponsor_type":"Other","conditions":"Candidemia","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Mortality","time_frame":"30 days"}]}
{"nct_id":"NCT01453816","start_date":"2011-05-31","phase":"N/A","enrollment":0,"brief_title":"Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered in Patients With Renal Failure","official_title":"An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Into the Renal Artery and Intravenously in Patients With Renal Failure","primary_completion_date":"2014-12-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2015-06-30","last_update":"2017-07-21","description":"The intent of this clinical study is to answer the questions: 1. Is the proposed treatment safe 2. Is treatment effective in improving the disease pathology of patients with Renal Failure and clinical outcomes","other_id":"ADI-ME-RF-001","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Males and Females between Age 18 and 80 years.\r\n\r\n          -  Chronic Kidney Disease(CKD) patients of stage III, IV, or V\r\n\r\n          -  Patient should be afebrile 24 hours prior to procedure.\r\n\r\n          -  Up to date on all age and gender appropriate cancer screening per American Cancer\r\n             Society.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Acute Renal Failure\r\n\r\n          -  Severe co-morbidities like cardiac insufficiency, congestive cardiac failure,\r\n             malignancy, infection, sepsis and bed sores.\r\n\r\n          -  Hemoglobin level below 6g/dl or at the discretion of the physician depending on\r\n             patient's overall condition.\r\n\r\n          -  Chronic kidney disease due to autoimmune aetiology, connective tissue disease,\r\n             amyloidosis and storage disorders.\r\n\r\n          -  Females who are pregnant or nursing or females of childbearing potential who are\r\n             unwilling to maintain contraceptive therapy for the duration of the study\r\n\r\n          -  Life expectancy < 6 months due to concomitant illnesses.\r\n\r\n          -  Exposure to any investigational drug or procedure within 1 month prior to study entry\r\n             or enrolled in a concurrent study that may confound results of this study.\r\n\r\n          -  Active infectious disease. Patients known to have tested positive for Human\r\n             immunodeficiency virus (HIV), Human T-lymphotropic virus(HTLV), Hepatitis B\r\n             (HBV),Hepatitis C (HCV), Cytomegalovirus (CMV) and/or syphilis will be evaluated by an\r\n             expert as to patient eligibility based on the patient's infectious status\r\n\r\n          -  Any illness which, in the Investigator's judgment, will interfere with the patient's\r\n             ability to comply with the protocol, compromise patient safety, or interfere with the\r\n             interpretation of the study results\r\n\r\n          -  Patients on chronic immunosuppressive transplant therapy\r\n\r\n          -  Systolic blood pressure (supine) 90 mmHg or greater than 200mmHg\r\n\r\n          -  Resting heart rate > 100 bpm;\r\n\r\n          -  Active clinical infection within one week of enrollment.\r\n\r\n          -  Known drug or alcohol dependence or any other factors which will interfere with the\r\n             study conduct or interpretation of the results or who in the opinion of the\r\n             investigator are not suitable to participate.\r\n\r\n          -  History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in\r\n             the last five years.\r\n\r\n          -  Unwilling and/or not able to give written informed consent.\r\n      ","sponsor":"Ageless Regenerative Institute","sponsor_type":"Industry","conditions":"Renal Failure","interventions":[{"intervention_type":"Procedure","name":"Procedure: Harvesting and Isolation of Stem cells","description":"Adipose-Derived Stem Cells (ASCs) will be derived from the patient's adipose-derived tissue. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The cells will be delivered via catheter into the renal artery and intravenously."}],"outcomes":[{"outcome_type":"primary","measure":"Significant clinical improvement in serum creatinine and urine output (improvement in measured Glomerular Filtration Rate(GFR) by 50%)","time_frame":"3 months","description":"Compared to baseline"},{"outcome_type":"primary","measure":"number of participants with adverse events","time_frame":"1 week"},{"outcome_type":"primary","measure":"Significant clinical improvement in serum creatinine and urine output (improvement in measured Glomerular Filtration Rate(GFR) by 50%) at 6 months","time_frame":"6 months"},{"outcome_type":"primary","measure":"number of participants with adverse events","time_frame":"2 weeks"},{"outcome_type":"primary","measure":"number of participants with adverse events","time_frame":"4 weeks"},{"outcome_type":"secondary","measure":"Improvement in renal biopsy measured by the reduction of scarring etc as compared to baseline","time_frame":"3 months"},{"outcome_type":"secondary","measure":"Improvement in renal biopsy measured by the reduction of scarring etc as compared to baseline","time_frame":"6 months"}]}
{"nct_id":"NCT01350856","start_date":"2011-05-31","phase":"Phase 4","enrollment":1700,"brief_title":"Tracking Resistance to Artemisinin (TRAC)","official_title":"A Multicentre, Randomised Trial to Detect in Vivo Resistance of Plasmodium Falciparum to Artesunate in Patients With Uncomplicated Malaria.","primary_completion_date":"2014-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-12-31","last_update":"2015-06-01","description":"Because the artemisinins are the most potent antimalarial drugs, the reduction in parasite numbers is rapid. Therefore, early measures of reducing parasite counts are needed. This study will look at conventional markers of parasite reduction e.g. parasite clearance time, parasite reduction ratio, and the time to achieve a fall of 50%, 90% and 99% of the pre-treatment parasitaemia. Defining artemisinin resistance requires the use of artesunate (AS) alone because it is now appreciated that the partner drug in a combination treatment has a significant impact on the rate of parasite clearance. This study will dose patients for 3 days with AS alone (or longer until parasites clear) and measure the parasite count frequently in order to be able to define an accurate regression line of a graph of the natural logarithm of the parasite count (Y axis) versus time (X axis). This will be followed by a full course of an artemisinin combination therapy (ACT). Two different dose regimens of artesunate will be compared at all sites except those in western Cambodia, as unpublished observations from the Thai-Myanmar border suggest the standard lower daily dose of 2mg/kg may enable the earlier detection of low level resistance than a 4mg/kg daily dose.","other_id":"BAKMAL1101","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":0.5,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female, aged from 6 months to 65 years old, inclusive\r\n\r\n          -  Acute uncomplicated P. falciparum malaria, confirmed by positive blood smear with\r\n             asexual forms of P. falciparum (or mixed with non-falciparum species)\r\n\r\n          -  Asexual P. falciparum parasitaemia: 10,000 to 200,000/uL, determined on a thin or\r\n             thick blood film\r\n\r\n          -  Fever defined as > 37.5C tympanic temperature or a history of fever within the last\r\n             24 hours\r\n\r\n          -  Written informed consent (by legally acceptable representative in case of children)\r\n\r\n          -  Willingness and ability of the patients/guardians to comply with the study protocol\r\n             for the duration of the study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Signs of severe/complicated malaria (WHO, 2000)\r\n\r\n          -  Haematocrit < 25% or haemoglobin (Hb) < 8 g/dL at enrollment\r\n\r\n          -  Acute illness other than malaria requiring treatment\r\n\r\n          -  For females: pregnancy, breast feeding\r\n\r\n          -  Patients who have received artemisinin or a derivative or an artemisinin-containing\r\n             combination therapy (ACT) within the previous 7 days\r\n\r\n          -  History of allergy or known contraindication to artemisinins, or to the ACT to be used\r\n             at the site\r\n\r\n          -  Previous splenectomy\r\n      ","sponsor":"University of Oxford","sponsor_type":"Other","conditions":"Falciparum Malaria","interventions":[{"intervention_type":"Drug","name":"Drug: Artesunate 2","description":"Artesunate 2 mg/kg/day for 3 days followed by a full course of either artemether-lumefantrine or DHA-piperaquine or artesunate-mefloquine or artesunate-amodiaquine"},{"intervention_type":"Drug","name":"Drug: Artesunate 4","description":"Artesunate 4 mg/kg/day for 3 days followed by a full course of either artemether-lumefantrine or DHA-piperaquine or artesunate-mefloquine or artesunate-amodiaquine"}],"outcomes":[{"outcome_type":"primary","measure":"Parasite clearance rate","time_frame":"Day 42","description":"Defined by the slope of the linear portion of the natural logarithm parasite clearance curve."},{"outcome_type":"secondary","measure":"Parasite clearance time","time_frame":"Day 42","description":"Assessed by microscopy"},{"outcome_type":"secondary","measure":"Parasite reduction rates and ratios","time_frame":"Day 42","description":"Assessed by microscopy and quantitative PCR."},{"outcome_type":"secondary","measure":"Time for parasite count to fall","time_frame":"50%, 90%, and 99%","description":"Time for parasite count to fall to 50%, 90%, and 99% of initial parasite density"},{"outcome_type":"secondary","measure":"Fever clearance time","time_frame":"> 24 hours","description":"The time taken for tympanic temperature to fall below 37˚C and remain there for at least 24 hours"},{"outcome_type":"secondary","measure":"Gametocytemia in patients","time_frame":"days 0, 3, 7 and 14","description":"Proportion of patients with gametocytemia before, during and after treatment with artesunate, assessed at admission, on days 3, 7 and 14, stratified by presence of gametocytes at enrolment"},{"outcome_type":"secondary","measure":"Gametocyte carriage rates","time_frame":"14 days"},{"outcome_type":"secondary","measure":"In vitro susceptibility of P.falciparum to artemisinins","time_frame":"Day 42","description":"Measure the inhibitory concentrations (IC) 50, IC90, IC99 of P. falciparum responses to artemisinins ex vivo"},{"outcome_type":"secondary","measure":"Pharmacokinetics relationships for artesunate and Dihydroartemisinin (DHA)","time_frame":"Day 42","description":"Measure half-life, Cmax, AUC, Tmax of artesunate and DHA."},{"outcome_type":"secondary","measure":"Parasite molecular markers of drug resistance","time_frame":"Day 42","description":"To identify the parasite specific molecular marker which is correlated to artemisinin resistance"},{"outcome_type":"secondary","measure":"Identification of host factors that correlate with slow parasite clearance","time_frame":"Day 42","description":"To identify host factors influencing the clearance of P. falciparum, e.g. haemoglobinopathies and G6PD deficiency"},{"outcome_type":"secondary","measure":"Efficacy at D42","time_frame":"Day 42","description":"The cure rate of artesunate plus ACT treatments at 42 day of follow up."},{"outcome_type":"secondary","measure":"Pharmacodynamics relationships for artesunate and Dihydroartemisinin (DHA)","time_frame":"Day 42"}]}
{"nct_id":"NCT01369082","start_date":"2011-05-31","enrollment":75,"brief_title":"Extended Follow-Up After Islet Transplantation in T1D","official_title":"Extended Follow-Up After Islet Transplantation in Type 1 Diabetes (CIT-08)","primary_completion_date":"2017-07-31","study_type":"Observational","rec_status":"Completed","completion_date":"2017-07-31","last_update":"2017-11-09","description":"The purpose of this study is to provide patients who have received at least one islet transplant as a previous participant in a Clinical Islet Transplantation Consortium (CIT) clinical trial with maintenance immunosuppressive medications and to collect information about the safety of the medications and islet function.","other_id":"DAIT CIT-08","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":65,"population":"Cohort from Clinical Islet Transplantation (CIT) parent studies (refer to inclusion\r\n        criteria) who continue:\r\n\r\n          -  to have islet graft function and\r\n\r\n          -  are on prescribed immunosuppression medications to prevent rejection of their\r\n             transplant.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subjects who have received an islet transplant during participation in the following\r\n             Clinical Islet Transplantation (CIT) parent studies: CIT02 (NCT00464555), CIT03\r\n             (NCT00434850), CIT04 (NCT00468403), CIT05 (NCT00468442), CIT06 (NCT00468117), and\r\n             CIT07 (NCT00434811)\r\n\r\n          -  A functioning pancreatic islet graft (e.g., absence of graft failure as defined in\r\n             parent study) requiring immunosuppression\r\n\r\n          -  Willingness of participants to continue to use an approved method of contraception\r\n             during and 4 months after study participation\r\n\r\n          -  Ability to provide written informed consent\r\n\r\n          -  Resident of the United States of America\r\n\r\n          -  Documentation of the existence or lack of health insurance coverage and whether\r\n             immunosuppressants are covered.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  For female subjects-Positive pregnancy test, presently breast-feeding, or\r\n             unwillingness to use effective contraceptive measures for the duration of the study\r\n             and 4 months after discontinuation\r\n\r\n          -  For male subjects-Intent to procreate during the duration of the study or within 4\r\n             months after discontinuation or unwillingness to use effective measures of\r\n             contraception. Oral contraceptives, Norplant, Depo-Provera, and barrier devices with\r\n             spermicide are acceptable contraceptive methods; condoms used alone are not\r\n             acceptable.\r\n\r\n          -  Received an islet transplant in a non-CIT research study\r\n\r\n          -  Any medical condition that, in the opinion of the investigator, will interfere with\r\n             safe participation in the trial.\r\n      ","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","sponsor_type":"NIH","conditions":"Type 1 Diabetes (T1D)|Islet Transplantation","interventions":[{"intervention_type":"Drug","name":"Drug: Maintenance Immunosuppressive Treatment","description":"All immunosuppressive and immunomodulatory therapies are used presently to prevent rejection of transplanted islet cells. The agents listed are those used in the parent trials and continued in this trial, CIT08."}],"outcomes":[{"outcome_type":"primary","measure":"Duration of sustained islet allograft function","time_frame":"Month 36,48,60,72,84,96,108,120,132 and 144 status post last islet transplant","description":"A C-peptide >/= 0.3 ng/mL at 0, 60, or 90 minutes after a Mixed-Meal Tolerance Test (MMTT) will be considered evidence of insulin production by transplanted islets"},{"outcome_type":"secondary","measure":"Serum creatinine and calculated eGFR at each annual study visit","time_frame":"Month 36,48,60,72,84,96,108,120,132 and 144 status post last islet transplant","description":"Measured as part of each annual follow-up evaluation"},{"outcome_type":"secondary","measure":"Incidence of serious adverse events (SAEs) during the 12-month period preceding each annual study visit","time_frame":"Month 36,48,60,72,84,96,108,120,132 and 144 status post last islet transplant","description":"Insulin usage will be estimated from the one-week self report values"},{"outcome_type":"secondary","measure":"Insulin requirements during a one-week period preceding each annual study visit","time_frame":"Month 36,48,60,72,84,96,108,120,132 and 144 status post last islet transplant","description":"Insulin usage will be estimated from the one-week self report values"},{"outcome_type":"secondary","measure":"Incidence of severe hypoglycemic events during the 12-month period preceding each annual study visit","time_frame":"36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months, 120 months, 132 months and 144 months","description":"Numbers of severe hypoglycemic events will be estimated from the self report values obtained at each follow-up visit. Defined as an event with one of the following symptoms: memory loss; confusion; uncontrollable behavior; irrational behavior; unusual difficulty in awakening; suspected seizure; seizure; loss of consciousness; or visual symptoms, in which the subject was unable to treat him/herself and which was associated with either a blood glucose level <54 mg/dL (3.0 mmol/L) or prompt recovery after oral carbohydrate, IV glucose, or glucagon administration."},{"outcome_type":"secondary","measure":"HbA1c levels at each annual study visit","time_frame":"Month 36,48,60,72,84,96,108,120,132 and 144 status post last islet transplant","description":"Glycosylated hemoglobin test determination during each follow-up visit"},{"outcome_type":"secondary","measure":"Incidence of all-cause mortality","time_frame":"By month 144 status post last islet transplant"},{"outcome_type":"secondary","measure":"Donor-specific alloantibodies","time_frame":"By month 144 status post last islet transplant","description":"Subjects with confirmed graft failure will continue with annual study visits; however, metabolic assessments should not be completed. Subjects who were enrolled in islet-alone parent studies and who experience graft failure and subsequently stop immunosuppression will have alloantibody assessed 3 months after their last dose of immunosuppression."}]}
{"nct_id":"NCT01752868","start_date":"2011-05-31","phase":"N/A","enrollment":56,"brief_title":"Can Fish Oil and Phytochemical Supplements Mimic Anti-Aging Effects of Calorie Restriction?","official_title":"Can Fish Oil and Phytochemical Supplements Mimic Anti-Aging Effects of Calorie Restriction?","primary_completion_date":"2012-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-08-31","last_update":"2012-12-19","description":"The purpose of this study is to determine if a combination of 10 nutritional supplements provide health benefits that are consistent with protection against age-related disease. All supplements have been shown in previous studies to have health benefits when administered alone. The hypothesis is that 6 months of taking 10 nutritional supplements each day will provide beneficial changes in healthy related measures.","other_id":"BJH 6936-33","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":40,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  age 40-60 yr\r\n\r\n          -  body mass index of 21 - 30 kg/m2\r\n\r\n          -  sedentary to moderately active\r\n\r\n          -  eating a typical US diet\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  history of any chronic disease other than mild osteoarthritis\r\n\r\n          -  use of medications other than occasional use of non-steroidal anti-inflammatory drugs,\r\n             antihistamines, antacids or laxatives\r\n\r\n          -  use of nutritional supplements\r\n\r\n          -  smoking\r\n\r\n          -  alcohol intake greater than two drinks per day for women and three drinks per day for\r\n             men\r\n      ","sponsor":"Washington University School of Medicine","sponsor_type":"Other","conditions":"Healthy Volunteers","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Supplement","description":"Participants in this group will take the following nutritional supplements on a daily basis: curcumin, fish oil, resveratrol, sesamin, Acetyl-L-carnitine, lipoic acid, green and black teas, quercetin, pomegranate, cinnamon bark."}],"outcomes":[{"outcome_type":"primary","measure":"Carotid-femoral pulse wave velocity","time_frame":"Baseline and 6 months"}]}
{"nct_id":"NCT01247922","start_date":"2011-05-23","phase":"Phase 2","enrollment":4,"brief_title":"Single-agent Erlotinib in Patients Previously Treated With Oral Etoposide in Protocol OSI-774-205","official_title":"Open-label Phase 2 Study of Single-agent Erlotinib for Patients With Pediatric Ependymoma Previously Treated With Oral Etoposide in Protocol OSI-774-205","primary_completion_date":"2012-09-13","study_type":"Interventional","rec_status":"Terminated","completion_date":"2012-09-13","last_update":"2019-06-19","description":"Participants that were assigned to the oral etoposide treatment arm in protocol OSI-774-205 and either progressed while on study or discontinued due to unacceptable toxicity related to etoposide were allowed to participate in this study to assess the safety profile of single-agent erlotinib in participants with recurrent or refractory pediatric ependymoma.","other_id":"OSI-774-206","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":1,"maximum_age":21,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients must have been enrolled in OSI-774-205, been randomized to oral etoposide and\r\n             either progressed while on study or discontinued due to unacceptable toxicity related\r\n             to etoposide\r\n\r\n          -  Performance status: Lansky  50% for patients  10 years of age or younger or\r\n             Karnofsky  50% for patients greater than 10 years of age\r\n\r\n          -  Patients must have recovered from any acute toxicity to any prior anti-cancer\r\n             treatment\r\n\r\n          -  Total bilirubin  1.5 x upper limit of normal (ULN) for age, serum glutamic pyruvic\r\n             transaminase (SGPT) ALT  3 x ULN\r\n\r\n          -  Serum creatinine based on age OR Creatinine Clearance/Glomerular Filtration Rate (GFR)\r\n              70 mL/min/m2\r\n\r\n          -  Patients must be neurologically stable for at least 7 days before registration\r\n\r\n          -  Patients, both males and females, with reproductive potential must agree to practice\r\n             effective contraceptive measures for the duration of study drug therapy and for at\r\n             least 90 days after completion of study drug therapy\r\n\r\n          -  Patients must be able to take erlotinib orally\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Taking strong/moderate CYP3A4 or CYP1A2 inhibitors/inducers  14 days before\r\n             registration\r\n\r\n          -  Have received any other chemotherapy or immunotherapy to treat ependymoma after\r\n             discontinuation from OSI-774-205\r\n\r\n          -  Taking proton pump inhibitors  14 days before registration\r\n\r\n          -  Participating in another investigational drug trial while on study\r\n\r\n          -  Pregnant or breast-feeding\r\n      ","sponsor":"OSI Pharmaceuticals","sponsor_type":"Industry","conditions":"Ependymoma","interventions":[{"intervention_type":"Drug","name":"Drug: Erlotinib","description":"continuous oral Erlotinib 85 mg/m^2 per day"}],"outcomes":[{"outcome_type":"primary","measure":"Safety Assessed Through Evaluation of Physical Examinations, Vital Signs, Clinical Laboratory Tests, and Adverse Events (AEs)","time_frame":"From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days)","description":"Safety is monitored through AEs, which includes abnormal or clinically significant vital sign assessments, laboratory test, physical examination findings associated with signs and/or symptoms requiring withdrawal, dose modification or medical intervention. A treatment-emergent adverse event (TEAE) was defined as an adverse event observed after starting administration of the study drug. An AE was considered serious (SAE) if it resulted in death, a life-threatening situation, inpatient hospitalization or prolongation of an existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a patient who received study drug or other important medical events."},{"outcome_type":"secondary","measure":"Best Overall Response","time_frame":"End of treatment (The mean treatment duration was 170.5 days.)","description":"Best overall response was derived from an integrated clinical assessment by the study investigator as per institutional standards. This included radiographic assessments deemed appropriate by the investigator in the normal care of the patient. A determination of best overall response at the end of study treatment (complete response, partial response, minor response or stable disease) was only made if (1) any disease-related neurologic symptoms were stable or improving over the interval of the radiographic assessment and (2) corticosteroid dosing for the control of tumor-related signs/symptoms was stable or decreasing.If the investigator deems that a radiographic assessment is not needed, then evidence of clinical improvement may be used to determine best response provided that corticosteroid dosing for tumor-related signs/symptoms is stable or decreasing."},{"outcome_type":"secondary","measure":"Median Treatment Duration","time_frame":"From first dose of study drug up to last dose of study drug (The mean treatment duration was 170.5 days)"}]}
{"nct_id":"NCT01340937","start_date":"2011-05-10","phase":"Phase 3","enrollment":2808,"brief_title":"A Study of V419 Given Concomitantly With Prevnar 13 and RotaTeq (V419-006)","official_title":"A Phase III Randomized, Partially Double-Blind, Active-Comparator-Controlled, Lot-to-Lot Consistency Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 6 Months Concomitantly With Prevnar 13 and RotaTeq ","primary_completion_date":"2012-12-18","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-07-26","last_update":"2018-11-15","description":"This study will determine whether three manufacturing lots of V419 (PR5I) induce similar immune responses to all of the antigens contained in V419 when given concomitantly with Prevnar13 and RotaTeq.","other_id":"V419-006","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":0.12603,"maximum_age":0.24384,"population":"","criteria":"\n        Inclusion Criteria :\r\n\r\n          -  Participant is a healthy infant\r\n\r\n          -  Participant has received one dose of monovalent hepatitis B vaccine prior to 1 month\r\n             of age\r\n\r\n        Exclusion Criteria :\r\n\r\n          -  Participant has received more than one dose of monovalent hepatitis B vaccine or\r\n             hepatitis B based combination vaccine prior to study entry\r\n\r\n          -  Participant has been vaccinated with any acellular pertussis or whole cell pertussis\r\n             based combination vaccines, haemophilus influenzae type b conjugate, poliovirus,\r\n             pneumococcal conjugate or pneumococcal polysaccharide, rotavirus, measles, mumps,\r\n             rubella, or varicella vaccines or any combination of the above\r\n\r\n          -  Participant has had an illness with fever within 24 hours of study enrollment\r\n\r\n          -  Participant was vaccinated with any non-study vaccine (i.e. inactivated, conjugated or\r\n             live virus vaccine within 30 days prior to enrollment, except for inactivated\r\n             influenza vaccine, which is permitted 15 days or more prior to enrollment\r\n\r\n          -  Participant or his/her mother has hepatitis B surface antigen (HBsAg) seropositivity\r\n             (by medical history)\r\n\r\n          -  Participant has a history of haemophilus influenzae type B, hepatitis B, diphtheria,\r\n             tetanus, pertussis, poliomyelitis, rotavirus, or pneumococcal infection\r\n      ","sponsor":"Merck Sharp & Dohme Corp.","sponsor_type":"Industry","conditions":"Bacterial Infections|Virus Diseases","interventions":[{"intervention_type":"Biological","name":"Biological: V419","description":"V419 (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Outer Membrane Protein Complex], and Hepatitis B [Recombinant] Vaccine) (from one of three lots) 0.5 mL intramuscular injection at 2, 4, and 6 months of age."},{"intervention_type":"Biological","name":"Biological: PENTACEL","description":"PENTACEL 0.5 mL intramuscular injection at 15 months of age in the V419 groups and at 2, 4, 6, and 15 months of age in the control group"},{"intervention_type":"Biological","name":"Biological: Prevnar 13","description":"Prevnar 13 0.5 mL intramuscular injection at 2, 4, 6, and 15 months of age"},{"intervention_type":"Biological","name":"Biological: RotaTeq","description":"RotaTeq 2 mL oral dose at 2, 4, and 6 months of age"},{"intervention_type":"Biological","name":"Biological: Recombivax HB vaccine","description":"Recombivax HB vaccine 0.5 mL intramuscular injection at 2 and 6 months of age"}],"outcomes":[{"outcome_type":"primary","measure":"Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen","time_frame":"Postdose 3 (Month 7)","description":"Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate."},{"outcome_type":"primary","measure":"Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen","time_frame":"Postdose 3 (Month 7)","description":"Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to Hepatitis B Surface Antigen. The unit of measure is milli International Units/mL (mIU/mL)."},{"outcome_type":"primary","measure":"Geometric Mean Concentration of Antibodies to Diphtheria Toxin","time_frame":"Postdose 3 (Month 7)","description":"Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to diphtheria toxin. The unit of measure is International Units/mL (IU/mL)."},{"outcome_type":"primary","measure":"Geometric Mean Concentration of Antibodies to Tetanus Toxin","time_frame":"Postdose 3 (Month 7)","description":"Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (ELISA) for anti-tetanus antibodies."},{"outcome_type":"primary","measure":"Geometric Mean Concentration of Antibodies to Pertussis Toxin","time_frame":"Postdose 3 (Month 7)","description":"Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. The unit of measure is ELISA units/mL (EU/mL)."},{"outcome_type":"primary","measure":"Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin","time_frame":"Postdose 3 (Month 7)","description":"Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin."},{"outcome_type":"primary","measure":"Geometric Mean Concentration of Antibodies to Pertussis Pertactin","time_frame":"Postdose 3 (Month 7)","description":"Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin."},{"outcome_type":"primary","measure":"Geometric Mean Concentration of Antibodies to Pertussis Fimbriae","time_frame":"Postdose 3 (Month 7)","description":"Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae."},{"outcome_type":"primary","measure":"Geometric Mean Titer for Antibodies to Poliovirus Type 1","time_frame":"Postdose 3 (Month 7)","description":"Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 1. The unit of measure is titer (reciprocal of highest dilution with neutralizing activity)."},{"outcome_type":"primary","measure":"Geometric Mean Titer for Antibodies to Poliovirus Type 2","time_frame":"Postdose 3 (Month 7)","description":"Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 2."},{"outcome_type":"primary","measure":"Geometric Mean Titer for Antibodies to Poliovirus Type 3","time_frame":"Postdose 3 (Month 7)","description":"Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 3."},{"outcome_type":"secondary","measure":"Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen","time_frame":"Postdose 3 (Month 7)","description":"Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate. Response was evaluated for a titer >=0.15 µg/mL and >=1.0 µg/mL."},{"outcome_type":"secondary","measure":"Percentage of Participants Responding to Hepatitis B Surface Antigen","time_frame":"Postdose 3 (Month 7)","description":"Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to Hepatitis B Surface Antigen. Response was defined as a titer >=10 mIU/mL."},{"outcome_type":"secondary","measure":"Percentage of Participants Responding to Diphtheria Toxin","time_frame":"Postdose 3 (Month 7)","description":"Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to diphtheria toxin. Response was defined as a titer >=0.1 IU/mL."},{"outcome_type":"secondary","measure":"Percentage of Participants Responding to Tetanus Toxin","time_frame":"Postdose 3 (Month 7)","description":"Participant serum samples were collected for testing with an ELISA for anti-tetanus antibodies. Response was defined as a titer >=0.1 IU/mL."},{"outcome_type":"secondary","measure":"Percentage of Participants Responding to Pertussis Toxin","time_frame":"Postdose 3 (Month 7)","description":"Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was <4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer."},{"outcome_type":"secondary","measure":"Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin","time_frame":"Postdose 3 (Month 7)","description":"Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer."},{"outcome_type":"secondary","measure":"Percentage of Participants Responding to Pertussis Pertactin","time_frame":"Postdose 3 (Month 7)","description":"Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer."},{"outcome_type":"secondary","measure":"Percentage of Participants Responding to Pertussis Fimbriae","time_frame":"Postdose 3 (Month 7)","description":"Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer."},{"outcome_type":"secondary","measure":"Percentage of Participants Responding to Poliovirus Type 1","time_frame":"Postdose 3 (Month 7)","description":"Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 1. Response is defined as a titer >=8."},{"outcome_type":"secondary","measure":"Percentage of Participants Responding to Poliovirus Type 2","time_frame":"Postdose 3 (Month 7)","description":"Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 2. Response is defined as a titer >=8."},{"outcome_type":"secondary","measure":"Percentage of Participants Responding to Poliovirus Type 3","time_frame":"Postdose 3 (Month 7)","description":"Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 3. Response is defined as a titer >=8."},{"outcome_type":"secondary","measure":"Geometric Mean Concentration of Antibodies to Pertussis Toxin","time_frame":"Postdose 4 (Month 16)","description":"Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control."},{"outcome_type":"secondary","measure":"Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin","time_frame":"Postdose 4 (Month 16)","description":"Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control."},{"outcome_type":"secondary","measure":"Geometric Mean Concentration of Antibodies to Pertussis Pertactin","time_frame":"Postdose 4 (Month 16)","description":"Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control."},{"outcome_type":"secondary","measure":"Geometric Mean Concentration of Antibodies to Pertussis Fimbriae","time_frame":"Postdose 4 (Month 16)","description":"Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control."},{"outcome_type":"secondary","measure":"Percentage of Participants Responding to Pertussis Toxin","time_frame":"Postdose 4 (Month 16)","description":"Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control."},{"outcome_type":"secondary","measure":"Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin","time_frame":"Postdose 4 (Month 16)","description":"Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control."},{"outcome_type":"secondary","measure":"Percentage of Participants Responding to Pertussis Pertactin","time_frame":"Postdose 4 (Month 16)","description":"Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control."},{"outcome_type":"secondary","measure":"Percentage of Participants Responding to Pertussis Fimbriae","time_frame":"Postdose 4 (Month 16)","description":"Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control."},{"outcome_type":"secondary","measure":"Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes","time_frame":"Postdose 3 (Month 7)","description":"Participant serum samples were collected for testing with a multiplex electrochemiluminescence-based detection assay for serotype-specific pneumococcal polysaccharide antibodies. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control."},{"outcome_type":"secondary","measure":"Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions","time_frame":"Up to 5 days after any infant vaccination (up to 6 months)","description":"Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 Solicited injection site reaction: Pain, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, >5 cm. Grade 3 Solicited systemic reactions: Fever (Pyrexia), >=39.5°C rectal; Vomiting, >=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, >3 hours; Drowsiness (Somnolence), Sleeping most of the time or difficult to wake up; Appetite lost, Refuses >=3 feeds or refuses most feeds; Irritability, Inconsolable."},{"outcome_type":"secondary","measure":"Percentage of Participants With Elevated Temperature by Severity","time_frame":"Up to 5 days after any infant vaccination (up to 6 months)","description":"Maximum temperature (all routes) was based on actual temperatures recorded with no adjustments to the measurement route. Maximum temperature (rectal) was required of all participants if the reading by another method was >=38.0°C."}]}
{"nct_id":"NCT02719626","start_date":"2011-04-30","enrollment":740,"brief_title":"Improving The Safety And Nutritional Adequacy Of The Home Food Supply Of Elderly Recipients Of Home Delivered Meals","official_title":"Improving The Safety And Nutritional Adequacy Of The Home Food Supply Of Elderly Recipients Of Home Delivered Meals","primary_completion_date":"2013-05-31","study_type":"Observational","rec_status":"Completed","completion_date":"2013-05-31","last_update":"2016-03-25","description":"Rutgers University will partner with the Meals on Wheels America (MOWA) and affiliated agencies in five states to conduct a study designed to improve food safety nutrition and emergency preparedness among homebound elderly recipients of home delivered meals (HDM). This population is at increased risk for food borne diseases, as a result of unique physiological and behavioral factors, and is particularly vulnerable to any disruptions in the food system because of their lack of mobility. A multi-method research approach will be used with a target sample of 1,000 MOWA homebound elderly clients. Methods include the use of a novel UPC scanning technology that quickly and comprehensively catalogues all of the food in the clients' homes, a home food safety audit, and a face-to-face interview. The goal of the study is to provide an improved understanding of the unique food safety threats to this at-risk population, suggest easy, cost-effective ways of reducing known food safety risk factors, and provide clear guidelines about the amount and types of food most needed by this population in emergency situations. Dissemination of research findings and recommendations will be done through a partnership with EDEN and MOWA, both of which have national constituencies poised to act on the recommendations.","other_id":"10-551Mx","observational_model":"Case-Only","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":60,"population":"Home delivered meal recipients for at least 6 months, who: live alone, are 60 or more years\r\n        old, have no overt cognitive impairment, and are from 5 states (AR, CA, IA, NJ & SC; one\r\n        site per state).","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  60 or more years old\r\n\r\n          -  live alone\r\n\r\n          -  no overt cognitive impairment\r\n\r\n          -  receiving home delivered meals for at least 6 months prior to the in-home visit\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  < 60 years old\r\n\r\n          -  do not live alone\r\n\r\n          -  overt cognitive impairment\r\n\r\n          -  receiving home delivered meals for less than 6 months prior to the in-home visit\r\n      ","sponsor":"Rutgers, The State University of New Jersey","sponsor_type":"Other","conditions":"Food Safety|Nutritive Value|Homebound Persons|Frail Elderly","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Food Safety Kitchen Audit Score","time_frame":"Day 1","description":"A 7-scale home food safety kitchen audit score was calculated by summing the affirmative responses to the audit questions was calculated for each household. Items on each scale ranged from 3-12 for total score of 0 to 43 and all were weighted equally."},{"outcome_type":"primary","measure":"Nutritional Adequacy Ratio (NAR)","time_frame":"Day 1","description":"A household Nutrition Adequacy Ratio was calculated by summing nutrition values based on the daily values for a 2,000kcal diet for each food. NARs are ratios where 1 is recommended, >1 is more than recommended and <1 is inadequate."},{"outcome_type":"secondary","measure":"Nutritional Quality Score (QS)","time_frame":"Day 1","description":"A household summary nutrition quality score was calculated by summing up the NARs for 6 recommended nutrients and dividing the result by the NARs for the non-recommended nutrients in the home food supply for each household.\r\nQuality Score is a ratio where 1 is recommended, >1 is more than recommended and <1 is inadequate."}]}
{"nct_id":"NCT01621503","start_date":"2011-04-30","phase":"N/A","enrollment":250,"brief_title":"Prospective Comparative Clinical Study to Investigate the Use of the NON CONTACT TONO/PACHYMETER NT-530P","official_title":"Prospective Comparative Clinical Study to Investigate the Use of the NON CONTACT TONO/PACHYMETER NT-530P","primary_completion_date":"2013-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-01-31","last_update":"2013-06-28","description":"The primary objective of this clinical study is to collect clinical data to support an FDA 510(k) submission for the Nidek Non Contact Tono/ Pachymeter NT-530P. The secondary objective is to evaluate any adverse events found during the clinical study.","other_id":"NT530P-120210","intervention_model":"Parallel Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. IOP Measurement 1. 20 years or older who voluntarily agree to participate in this\r\n             study after receiving adequate explanation 2. Possible to participate in the study\r\n             regardless of existence of glaucoma\r\n\r\n          2. CCT Measurement 1. 20 years or older who voluntarily agree to participate in this\r\n             study after receiving adequate explanation 2. Possible to participate in the study\r\n             regardless of existence of glaucoma 3. Possible to participate in the study regardless\r\n             of existence of corneal diseases (such as Keratoconus, post-LASIK, and corneal scars)\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. IOP Measurement 1. Those with only one functional eye 2. Those with one eye having\r\n             poor or eccentric fixation 3. Those with corneal scarring or who have had corneal\r\n             surgery such as laser surgery 4. Microphthalmus 5. Buphthalmos 6. Contact lens wearers\r\n             7. Dry eyes 8. Blepharospasm 9. Nystagmus 10. Keratoconus 11. Those who have been\r\n             diagnosed as having corneal conjunctivitis or other infectious disease 12. Those with\r\n             central corneal thickness greater than 600 m or less than 500 m 13. A subject judged\r\n             to be ineligible for participating in the study by the physicians in charge\r\n\r\n          2. CCT Measurement 1. Those with only one functional eye 2. Those with one eye having\r\n             poor or eccentric fixation 3. Blepharospasm 4. Nystagmus 5. Those who have been\r\n             diagnosed as having corneal conjunctivitis or other infectious disease 6. A subject\r\n             judged to be ineligible for participating in the study by the physicians in charge\r\n      ","sponsor":"Nidek Co. LTD.","sponsor_type":"Industry","conditions":"IOP Ranges(mmHg): 7 to 16, >16 to <23, and 23 or More","interventions":[{"intervention_type":"Device","name":"Device: NT-530P","description":"intraocular pressure and central corneal thickness measurement"}],"outcomes":[{"outcome_type":"primary","measure":"central corneal thickness","time_frame":"one day"},{"outcome_type":"primary","measure":"intraocular pressure","time_frame":"one day"}]}
{"nct_id":"NCT01340092","start_date":"2011-04-30","phase":"N/A","enrollment":192,"brief_title":"Use of a Family Navigator in Families With Children Newly Diagnosed With Autism Spectrum Disorder","official_title":"Use of a Family Navigator in Families With Children Newly Diagnosed With Autism Spectrum Disorder","primary_completion_date":"2014-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-05-31","last_update":"2016-04-25","description":"The purpose of this study is to see whether or not Family Navigators, who 1 ) help families after their child is diagnosed with autism and help them get autism specific services for their child 2) help families identify barriers to obtaining these services and 3) help families problem solve to overcome these barrier, are helpful to parents of a child newly diagnosed with an Autism Spectrum Disorder.","other_id":"29964","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":15,"maximum_age":64,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Child with a new confirmed diagnosis of Autism Spectrum Disorder\r\n\r\n          -  Child is under 8 years of age\r\n\r\n          -  Parent is the mother, father and/or legal guardian of the child and identifies\r\n             themselves as the primary caregiver\r\n\r\n          -  Primary caregiver speaks English, Spanish, Haitian Creole, Somali, Vietnamese,\r\n             Portuguese or Chinese\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Parent or legal guardian has psychosis\r\n\r\n          -  Parent or legal guardian endorses suicidal ideation\r\n\r\n          -  Parent or legal guardian actively using illicit drugs\r\n\r\n          -  Parent or legal guardian expected to leave area within 6 months\r\n      ","sponsor":"Boston Medical Center","sponsor_type":"Other","conditions":"Autistic Disorder","interventions":[{"intervention_type":"Other","name":"Other: Family Navigator","description":"Families in the intervention group will receive approximately six sessions with a Family Navigator. The Family Navigator will:\r\nHelp family identify key issues they need to address to get their child autism-specific services\r\nHelp family address barriers to obtaining these services and strategize approaches to overcome them."}],"outcomes":[{"outcome_type":"primary","measure":"Hours of Services","time_frame":"6 months after enrollment","description":"Mean number of autism-specific service hours received per week"},{"outcome_type":"primary","measure":"Receipt of adequate services","time_frame":"6 months after enrollment","description":"As defined by 25 hours/week"},{"outcome_type":"primary","measure":"Time to Receipt of Services","time_frame":"6 months after enrollment","description":"Difference between the date of the IEP/IFPS and date the child first received services"},{"outcome_type":"secondary","measure":"Family Psychological Functioning","time_frame":"6 months after enrollment","description":"Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR).\r\nParenting Stress - Short Form (PSI)\r\nPerceived Stress Scale- Self-Report (PSS)\r\nMedical Outcomes Study Social Support (MOS-SS)"},{"outcome_type":"secondary","measure":"Family Psychological Functioning","time_frame":"Baseline","description":"Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR).\r\nParenting Stress - Short Form (PSI)\r\nPerceived Stress Scale- Self-Report (PSS)\r\nMedical Outcomes Study Social Support (MOS-SS)"}]}
{"nct_id":"NCT01392027","start_date":"2011-04-30","phase":"N/A","enrollment":712,"brief_title":"Biospecimens for Identification of Diseases of the Pancreas.","official_title":"Biospecimens for the Early Detection, Prevention, Diagnosis and Treatment of Diseases of the Pancreas.","primary_completion_date":"2017-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-08-31","last_update":"2017-11-08","description":"This proposed project is designed to collect data and specimens from patients/subjects presenting to the University of Michigan with a disease affecting the pancreas (or specific control populations). This protocol is focused on collecting data, blood samples, and tissue on subjects with pancreatic diseases, including pancreatic cancer, pancreatic cysts, pancreatitis, diabetic controls, jaundice/biliary obstruction controls, and otherwise healthy controls. We are collecting up to 50 mls of blood for research purposes only. Plasma, serum and buffy coat are collected and stored according to strict SOPs.","other_id":"P50-CA13081001A2","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Overall Inclusion (all subjects must meet these criteria to be enrolled)\r\n\r\n          -  Adults 18 years of age or older\r\n\r\n          -  Able to physically tolerate removal of 50 ml of blood\r\n\r\n          -  Willing to sign informed consent.\r\n\r\n        Exclusion Criteria:Overall Exclusion (for all subjects)\r\n\r\n          -  Pregnant or lactating\r\n\r\n          -  Known HIV/AIDS or Hepatitis C\r\n\r\n          -  Prepped for colonoscopy at the time of blood collection\r\n\r\n          -  Unable to understand English\r\n\r\n          -  Receiving chemotherapy or radiation at time of enrollment\r\n\r\n          -  Any cancer within 5 years of enrollment except any of the following:\r\n\r\n               -  Squamous cell carcinoma of the skin or Basal cell carcinoma of the skin\r\n\r\n               -  Carcinoma in situ of the cervix, Stages Ia or Ib invasive squamous cell carcinoma\r\n                  of the cervix treated by surgery only. (Excluded if had pelvic radiation)\r\n\r\n               -  Stage Ia Grade 1 adenocarcinoma of the endometrium treated with surgery\r\n      ","sponsor":"University of Michigan","sponsor_type":"Other","conditions":"Pancreatic Cancer|Chronic Pancreatitis|Type II Diabetes|Pancreatic Cysts|Healthy Control","interventions":[{"intervention_type":"Procedure","name":"Procedure: Blood Draw","description":"Blood draw for research specimens only"}],"outcomes":[{"outcome_type":"primary","measure":"Validation of glycoprotein panel as a pancreatic cancer biomarker","time_frame":"5 years","description":"To create a set of cases and controls to validate a novel glycoprotein panel for non-invasive or early detection of pancreatic cancer."}]}
{"nct_id":"NCT01377558","start_date":"2011-04-30","phase":"N/A","enrollment":100,"brief_title":"Effects of Different Types of Exercise Interventions in Patients With Type 2 Diabetes","official_title":"Effects of Different Types of Exercise Interventions in Patients With Type 2 Diabetes - Aerobic Endurance Training Versus Strength Endurance Training Versus Combined Aerobic Endurance and Strength Endurance Training -","primary_completion_date":"2011-11-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2012-06-30","last_update":"2011-06-23","description":"The purposes of the study are - to determine which kind of supervised exercise intervention (aerobic endurance training versus strength endurance training versus combined aerobic endurance and strength endurance training) is more effective in improving the metabolic parameters in typ 2 diabetes patients - to investigate what kind of intervention is more successful in reduction of concomitant diseases and improving quality of life - to assess what kind of intervention induces highest effects in long term persistence of these positive changes","other_id":"Gi-03-2011","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  diagnoses of type 2 diabetes (ADA criteria)\r\n\r\n          -  admitted diabetes treatments will be diet and oral hypoglycemic agents\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  sports intervention >60 minutes per week\r\n\r\n          -  medical conditions\r\n\r\n          -  preproliferative or proliferative retinopathy\r\n\r\n          -  instable coronary heart disease\r\n\r\n          -  inability to perform the scheduled physical activity programs\r\n\r\n          -  acute clinically significant intercurrent diseases\r\n      ","sponsor":"University of Giessen","sponsor_type":"Other","conditions":"Type 2 Diabetes","interventions":[{"intervention_type":"Other","name":"Other: Strength endurance training intervention","description":"The strength endurance training intervention group will perform eight exercises on weight machines (Milon circuit training- 60 seconds activity, 30 seconds break)\r\nweek 1-4: 15 minutes warm up (group) 1 session resistance training intensity 3 (Buskies) two times per week\r\nweek 5-13: 15 minutes warm up (group) 2 sessions resistance training intensity 5 (Buskies) two times per week\r\nweek 14-26: 15 minutes warm up (group) 3 sessions resistance training intensity 5 (Buskies) two times per week"},{"intervention_type":"Other","name":"Other: Aerobic endurance training intervention","description":"The aerobic endurance training group will use cardiovascular training devices\r\nweek 1-4: 15 minutes warm up (group) 15 minutes intervention at 80-100% vAT two times per week\r\nweek 5-13: 15 minutes warm up (group) 30 minutes intervention at 95-110% vAT two times per week\r\nweek 14-26: 15 minutes warm up (group) 45 minutes intervention at 95-110% vAT two times per week"},{"intervention_type":"Other","name":"Other: Combined aerobic endurance and strength endurance training","description":"week 1-4: 15 minutes warm up (group) 15 minutes intervention at 80-100% vAT once per week and 15 minutes warm up (group) 1 session resistance training intensity 3 (Buskies) once per week\r\nweek 5-13: 15 minutes warm up (group) 15 minutes intervention at 95-110% vAT and 1 session resistance training intensity 5 (Buskies) two times per week\r\nweek 14-26: 15 minutes warm up (group) 30 minutes intervention at 95-110% vAT and 1 session resistance training intensity 5 (Buskies) once a week and 15 minutes warm up (group) 15 minutes intervention at 95-110% vAT and 2 sessions resistance training intensity 5 (Buskies) once a week"}],"outcomes":[{"outcome_type":"secondary","measure":"Change in aortic pulse-wave velocity","time_frame":"3 and 6 months"},{"outcome_type":"secondary","measure":"Change in central aortic pressure","time_frame":"3 and 6 month"},{"outcome_type":"secondary","measure":"Change in endothelial dysfunction","time_frame":"3 and 6 months"},{"outcome_type":"secondary","measure":"Change of parodontitis","time_frame":"3 and 6 months"},{"outcome_type":"secondary","measure":"Change in concentration","time_frame":"3 and 6 months","description":"by d2-test"},{"outcome_type":"secondary","measure":"Change in renal function","time_frame":"3 and 6 months","description":"Creatininlevel, Albuminlevel (urine), Telomere length"},{"outcome_type":"secondary","measure":"Change in voluntary physical activity","time_frame":"3 and 6 months","description":"meassured by pedometer (one week)"},{"outcome_type":"secondary","measure":"Change in blood pressure","time_frame":"3 and 6 months"},{"outcome_type":"secondary","measure":"Change of cardiac output by Impedance cardiography","time_frame":"3 and 6 months","description":"by Task Force Monitor"},{"outcome_type":"secondary","measure":"Change of barorezeptorsensitivity","time_frame":"3 and 6 months","description":"by Task Force Monitor"},{"outcome_type":"secondary","measure":"Change in carotid-Intima-Media-Thickness","time_frame":"3 and 6 months"},{"outcome_type":"primary","measure":"Change in HbA1c-level (haemoglobin A1c)","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Change in HOMA-Index","time_frame":"3 and 6 months"},{"outcome_type":"secondary","measure":"Change in beta-cell-function","time_frame":"3 and 6 months","description":"Measured by OGTT (Oral Glucose Tolerance Test)"},{"outcome_type":"secondary","measure":"Change in fasting plasma glucose levels","time_frame":"3 and 6 months"},{"outcome_type":"secondary","measure":"Change in total cholesterol levels","time_frame":"3 and 6 months"},{"outcome_type":"secondary","measure":"Change in HDL-cholesterol levels","time_frame":"3 and 6 months"},{"outcome_type":"secondary","measure":"Change in LDL-cholesterol levels","time_frame":"3 and 6 months"},{"outcome_type":"secondary","measure":"Change in triglyceride levels","time_frame":"3 and 6 months"},{"outcome_type":"secondary","measure":"Change in antidiabetic medications","time_frame":"3 and 6 months","description":"Class and dosage of blood-glucose lowering drugs are recorded before, after 3 and 6 months"},{"outcome_type":"secondary","measure":"Change in inflammation markers","time_frame":"3 and 6 months","description":"CrP, blood count, interleukinstatus, cytokinstatus"},{"outcome_type":"secondary","measure":"Change in body weight","time_frame":"3 and 6 months"},{"outcome_type":"secondary","measure":"Change in body composition","time_frame":"3 and 6 months","description":"by Bio-impedance analysis, waist to hip ratio, range of thigh"},{"outcome_type":"secondary","measure":"Change in strength","time_frame":"3 and 6 months","description":"by Dr. Wolff Back Check"},{"outcome_type":"secondary","measure":"Change of maximum heart rate","time_frame":"3 and 6 months","description":"Measured by an incremental exercise test"},{"outcome_type":"secondary","measure":"Change of peak oxygen uptake","time_frame":"3 and 6 months","description":"Measured by an incremental exercise test"},{"outcome_type":"secondary","measure":"Change of vAT (ventilatory anaerobic threshold)","time_frame":"3 and 6 months","description":"Measured by an incremental exercise test"},{"outcome_type":"secondary","measure":"Change in quality of life","time_frame":"3 and 6 months","description":"by questionnaire: SF-12, EQ5"},{"outcome_type":"secondary","measure":"Change of nutrition","time_frame":"3 and 6 months","description":"by questionnaire: FEV, FFQ"},{"outcome_type":"secondary","measure":"Follow up of all parameters mentioned above","time_frame":"after 12 months","description":"Follow up after 12 months (6 months after completing the exercise intervention) without any supervised intervention"}]}
{"nct_id":"NCT01705951","start_date":"2011-04-30","phase":"N/A","enrollment":100,"brief_title":"Effect of Resistance Training on Tobacco-Related Cardiovascular Disease Risk","official_title":"Effect of Resistance Training on Tobacco-Related Cardiovascular Disease Risk","primary_completion_date":"2013-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2013-12-31","last_update":"2012-10-12","description":"This project is prompted by the urgent public health need to identify novel strategies to prevent and treat tobacco-related cardiovascular disease (CVD) and by compelling pilot data that suggests cessation of smoking results in rapid amelioration of endothelial function. The higher prevalence of CVD and metabolic syndrome in smokers have become major health care concerns. Therefore, finding optimal intervention strategies to combat these growing epidemics is imperative. We are investigating the efficacy of resistance training to ameliorate endothelial dysfunction, oxidative stress, inflammation, and insulin resistance in four groups: presence or absence of resistance training with or without cessation treatment + nicotine replacement. The investigators hypothesize that resistance training will improve cardiovascular function in smokers; however, the responses will be better in those who also stop smoking. In addition, resistance training will decrease smoking, however, the effects of counseling and nicotine replacement alone or counseling and nicotine replacement in conjunction with resistance training will be better than resistance training alone.","other_id":"19KT-0028","allocation":"Randomized","intervention_model":"Factorial Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":35,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Young Adults (18-35 yrs.)\r\n\r\n          -  Male and female smokers\r\n\r\n          -  Smokers (smoked at least one cigarette a day for 15 or more days in the last month and\r\n             has smoked 100 cigarettes in life)\r\n\r\n          -  1-3 years experience consistently exercising/training at 2 days/wk of RT and 1\r\n             day/wk of aerobic exercise\r\n\r\n          -  Capable of providing informed consent\r\n\r\n          -  UCLA students/staff and Non UCLA student/staff\r\n\r\n          -  Participant in good health as determined by baseline visit\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Documented CAD\r\n\r\n          -  Has had cardiac surgery\r\n\r\n          -  Currently in weight loss or exercise program in the 6 months prior to participation.\r\n\r\n          -  Use of medications that influence CV function or preclude the ability to train\r\n\r\n          -  Syndromes or prescribed medications that may influence CVD, body composition, or\r\n             insulin action (e.g. prednisone, Ritalin, Adderall, GH)\r\n\r\n          -  Unable to exercise\r\n\r\n          -  Diagnosed with syndromes or diseases that may influence body composition and CV risk\r\n             (e.g. Cushing syndrome).\r\n\r\n          -  Known heart arrhythmia and/or abnormalities found in electrocardiogram (ECG) reading\r\n             that would prevent someone from performing the exercise intervention. If the subject\r\n             demonstrates abnormal ECG during their pre-intervention visit (or any follow-up visit)\r\n             the subject's ECG will be reviewed (for approval) by a cardiologist to continue in the\r\n             study.\r\n\r\n          -  Pregnant\r\n\r\n          -  Use of hormonal contraceptives\r\n\r\n          -  Currently in a smoking cessation program including use of NRT within the month of\r\n             participation\r\n      ","sponsor":"University of California, Los Angeles","sponsor_type":"Other","conditions":"Smoking|Cardiovascular Disease Risk","interventions":[{"intervention_type":"Other","name":"Other: Resistance Training (RT)","description":"Resistance Training program 3x/week at 60 minutes per session for 12 weeks."},{"intervention_type":"Biological","name":"Biological: Nicotine Replacement Therapy (NRT)","description":"Nicotine patch for 12 weeks (21mg, 14mg, 7mg.) and referral to California Smoker's Helpline for 6 sessions of smoking cessation counseling."}],"outcomes":[{"outcome_type":"primary","measure":"Endothelial function as determined by brachial artery Flow-Mediated Dilation (FMD)","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"Smoking cessation percentage","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"Arterial stiffness (including PWV and AIx)","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"Number of cigarettes smoked","time_frame":"12 weeks"},{"outcome_type":"other","measure":"Endothelial Progenitor Cells (EPC) count","time_frame":"12 weeks","description":"EPC count is measured using a novel flow cytometry protocol."},{"outcome_type":"other","measure":"Insulin sensitivity by Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT)","time_frame":"12 Weeks"},{"outcome_type":"other","measure":"Plasma biomarkers inflammation/oxidative stress (oxidized low density lipoprotein (OxLDL), CRP)","time_frame":"12 Weeks"},{"outcome_type":"other","measure":"Body Composition","time_frame":"12 Weeks","description":"Lean mass and fat mass are measured by the Dual Energy X-ray Absorptiometry (DEXA) Scan."},{"outcome_type":"other","measure":"Muscle Strength","time_frame":"12 Weeks","description":"Muscle strength is evaluated by a one-Repetition Maximum (1RM) protocol and VO2 peak is assessed by a maximal incremental cardiopulmonary exercise test."}]}
{"nct_id":"NCT01234311","start_date":"2011-03-31","phase":"Phase 3","enrollment":1245,"brief_title":"A Study of Tasquinimod in Men With Metastatic Castrate Resistant Prostate Cancer","official_title":"A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Tasquinimod in Men With Metastatic Castrate Resistant Prostate Cancer","primary_completion_date":"2015-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-08-31","last_update":"2015-10-21","description":"This is a Phase 3 randomized, double blind, placebo controlled study of tasquinimod in asymptomatic to mildly symptomatic patients with metastatic CRPC to confirm the effect of tasquinimod on delaying disease progression compared with placebo. Approximately 1200 eligible patients with metastatic CRPC will be randomly assigned in a 2:1 ratio to 1 of 2 treatment groups: Treatment Group A (tasquinimod 0.25, 0.5, or 1 mg/day; n=800) or Treatment Group B (placebo; n=400).","other_id":"10TASQ10","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"Male","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age at least 18 years at the time of signing the informed consent form. For patients\r\n             in Taiwan the minimum age is 20 years.\r\n\r\n          2. Histologically confirmed diagnosis of adenocarcinoma of the prostate.\r\n\r\n          3. Evidence of bone metastatic disease on radiographic examination, whether from bone\r\n             scan or other imaging modality.\r\n\r\n          4. Castrate levels of serum testosterone (50 ng/dL or 1.7 nmol/L).\r\n\r\n          5. Evidence of progressive disease.\r\n\r\n          6. Karnofsky score 70%.\r\n\r\n          7. Meet screening laboratory values as specified in thr protocol.\r\n\r\n          8. If sexually active with partner of childbearing potential, patient will agree to use\r\n             adequate contraceptive methods (barrier contraceptive with spermicide or vasectomy)\r\n             while on study drug. The adequate contraceptive method should be continued for 14 days\r\n             after the patient stops taking study drug.\r\n\r\n          9. No evidence (within 5 years) of prior malignancies (except successfully treated basal\r\n             cell or squamous cell carcinoma of the skin).\r\n\r\n         10. Able to swallow and retain oral medication.\r\n\r\n         11. Able to adhere to the study visit schedule and other protocol requirements.\r\n\r\n         12. Ability to comprehend the full nature and purpose of the study, including possible\r\n             risks and side effects; ability to cooperate with the investigator and to comply with\r\n             the requirements of the entire study.\r\n\r\n         13. Able (or patient's legal guardian, if applicable) to sign and date the written\r\n             informed consent after being informed of the full nature and purpose of the study,\r\n             including possible risks and side effects, and given ample time and opportunity to\r\n             read and understand this information.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Prior cytotoxic chemotherapy for the treatment of prostate ca within 2 years or within\r\n             4 weeks for Estracyt (estramustine) prior to study treatment.\r\n\r\n          2. Previous anticancer therapy using radiation, biologics or vaccines, including\r\n             abiraterone, TAK-700 (Orteronel), or MDV3100 within 4 weeks prior or sipuleucel-T\r\n             (Provenge) within 2 weeks prior to the start of study treatment. If radiation therapy\r\n             is applied after baseline scan, a new baseline scan needs to be done at least 4 weeks\r\n             after the radiation therapy.\r\n\r\n          3. Previous therapy with antiandrogens within 4 weeks (within 6 weeks for bicalutamide\r\n             eg, Casodex) prior to study treatment.\r\n\r\n          4. Concurrent use of other anticancer agents or treatments, with the following\r\n             exceptions:\r\n\r\n              Ongoing treatment with luteinizing hormone-releasing hormone agonists or\r\n             antagonists, denosumab (Prolia) or bisphosphonate (eg, zoledronic acid) is allowed.\r\n             Ongoing treatment should be kept at a stable schedule; however, if medically required,\r\n             a change of dose, compound, or both is allowed.\r\n\r\n          5. Any treatment modalities involving major surgery within 4 weeks prior to the start of\r\n             study treatment.\r\n\r\n          6. Prostate ca pain that requires ongoing treatment with narcotic analgesics or warrants\r\n             the initiation of radio- or chemotherapy.\r\n\r\n          7. Ongoing treatment with warfarin unless the international normalized ratio (INR) is\r\n             well controlled and below 4 (Section 4.6.8.1).\r\n\r\n          8. Maintenance treatment with corticosteroids corresponding to a prednisolone or\r\n             prednisone dose above 10 mg/day. The dose must have been stable for at least 5 days.\r\n\r\n          9. Systemic exposure to ketoconazole or other strong cytochrome P450 (CYP) 3A4 isozyme\r\n             inhibitors or inducers within 14 days prior to the start of study treatment. Systemic\r\n             exposure to amiodarone is not allowed within 1 year prior to the start of study\r\n             treatment.\r\n\r\n         10. Ongoing treatment with sensitive CYP1A2 substrate or CYP1A2 substrate with narrow\r\n             therapeutic range at the start of study treatment.\r\n\r\n         11. Ongoing treatment with CYP3A4 substrate with narrow therapeutic range at the start of\r\n             study treatment.\r\n\r\n         12. Simultaneous participation in any other study involving treatment with investigational\r\n             drugs or having received treatment with investigational drugs less than 4 weeks prior\r\n             to the start of study treatment.\r\n\r\n         13. Myocardial infarction, percutaneous coronary intervention, acute coronary syndrome,\r\n             coronary artery bypass graft, class III/IV congestive heart failure, cerebrovascular\r\n             accident, transient ischemic attack, or limb claudication at rest, within 6 months\r\n             prior to start of study treatment and ongoing symptomatic dysrhythmias, unstable\r\n             angina, uncontrolled hypertension, and uncontrolled atrial or ventricular arrhythmias.\r\n\r\n         14. History of pancreatitis.\r\n\r\n         15. Known brain or epidural metastases.\r\n\r\n         16. Known positive serology for HIV (patients with known history of HIV will be excluded\r\n             because of potential for unforeseen toxicity and morbidity in an immunocompromised\r\n             host).\r\n\r\n         17. Chronic hepatitis with advanced, decompensated hepatic disease or cirrhosis of the\r\n             liver or history of a chronic viral hepatitis or known viral hepatitis carrier\r\n             (patients who have recovered from hepatitis will be allowed to enter the study).\r\n\r\n         18. Patients with active tuberculosis (TB), or with known, untreated latent TB.\r\n             (Country-specific TB therapy should have been given for at least 30 days prior to the\r\n             start of study treatment and the patient should intend to complete the entire course\r\n             of that therapy.)\r\n\r\n         19. Any condition, including other active or latent infections, medical or psychiatric\r\n             conditions, or the presence of laboratory abnormalities, which could confound the\r\n             ability to interpret data from the study or places the patient at unacceptable risk if\r\n             he participates in the study.\r\n\r\n         20. Any patient who in the opinion of the investigator should not participate\r\n      ","sponsor":"Active Biotech AB","sponsor_type":"Industry","conditions":"Prostate Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: tasquinimod","description":"Tasquinimod up to a maximum maintenance dose of 1 mg once daily, administrated orally (capsule)"},{"intervention_type":"Drug","name":"Drug: Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Tasquinimod in Men with Metastatic Castrate Resistant Prostate Cancer","time_frame":"5 years","description":"The primary endpoint is progression-free survival (PFS) defined as the time from the date of randomization to the date of radiological progression or death."}]}
{"nct_id":"NCT01305538","start_date":"2011-03-31","phase":"Phase 2","enrollment":100,"brief_title":"Crossover Post-herpetic Neuralgia (PHN)","official_title":"A Randomized, Multicenter, Double-blind, Placebo-controlled, Cross-over Study of the Efficacy and Safety of BMS-954561 in Patients With Post-herpetic Neuralgia (PHN)","primary_completion_date":"2012-02-29","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-06-30","last_update":"2015-12-07","description":"The purpose of the study is to evaluate the efficacy of study drug (BMS-954561) as compared to placebo in the treatment of patients with post-herpetic neuralgia (PHN).","other_id":"CN169-002","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patient with Post-Herpetic Neuralgia (PHN) as defined as pain present for more than 6\r\n             months after the onset of a herpes zoster skin rash affecting the trigeminal,\r\n             cervical, thoracic, lumbar, or sacral regions.\r\n\r\n          -  Based on patient diary information collected during the Baseline week (day -7 to\r\n             randomization Day 1), patient has completed at least 5 diary entries and has an\r\n             average weekly pain rating of at least 4 on the 11-point pain rating scale.\r\n\r\n          -  The patient is able to satisfactorily complete, in the Investigator's judgment, the\r\n             Cognitive Battery.\r\n\r\n          -  Male or female, 18-85 years of age.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Other severe pain that may potentially confound pain assessment.\r\n\r\n          -  History of complete lack of response to pregabalin (at least 300 mg qd for 4 weeks) or\r\n             gabapentin (at least 1800 mg qd for 4 weeks).\r\n\r\n          -  Hemoglobin A1c > 9%\r\n\r\n          -  Hemoglobin  9 g/dL.\r\n\r\n          -  Active herpes zoster or known viral infection.\r\n\r\n          -  Previous neurolytic or neurosurgical therapy for PHN.\r\n\r\n          -  Estimated glomerular filtration rate (eGFR) according to the re-expressed abbreviated\r\n             (four-variable) Modification of Diet in Renal Disease (MDRD) Study equation \r\n             40ml/min/1.73m2.\r\n\r\n          -  Patients who have been on a stable dose of anticonvulsant,anticholinergic, antiviral\r\n             medications, nicotine replacements, or any other smoking cessation medications for <4\r\n             weeks prior to randomization. Patients who are on stable doses for => 4 weeks prior to\r\n             randomization are allowed, however, there should be no adjustments to the dose of\r\n             these medications during study.\r\n\r\n          -  Patients currently on more than one drug for treatment of neuropathic pain (low dose\r\n             opioids, antidepressants, or anticonvulsants). Patients are allowed to participate if\r\n             on a stable dose for at least 4 weeks prior to randomization (Day1) and should remain\r\n             stable during course of study.\r\n      ","sponsor":"Bristol-Myers Squibb","sponsor_type":"Industry","conditions":"Post-Herpetic Neuralgia (PHN)","interventions":[{"intervention_type":"Drug","name":"Drug: BMS-954561"},{"intervention_type":"Drug","name":"Drug: BMS-954561"},{"intervention_type":"Drug","name":"Drug: Placebo"}],"outcomes":[{"outcome_type":"secondary","measure":"Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).","time_frame":"Open-Label Phase: Weeks 8"},{"outcome_type":"secondary","measure":"Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).","time_frame":"Open-Label Phase: Weeks 12"},{"outcome_type":"secondary","measure":"Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).","time_frame":"Double-blind Treatment Phase: Weeks 10"},{"outcome_type":"secondary","measure":"Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).","time_frame":"Open-Label Phase: Weeks 2"},{"outcome_type":"secondary","measure":"Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).","time_frame":"Open-Label Phase: Weeks 4"},{"outcome_type":"secondary","measure":"Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events.","time_frame":"Double-blind Treatment Phase: Weeks 5"},{"outcome_type":"primary","measure":"The primary endpoint of this study is the average pain score for BMS-954561 vs. placebo.","time_frame":"up to 10 weeks"},{"outcome_type":"secondary","measure":"Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).","time_frame":"Screening/Baseline Phase: Baseline"},{"outcome_type":"secondary","measure":"Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).","time_frame":"Double-blind Treatment Phase: Weeks 1"},{"outcome_type":"secondary","measure":"Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).","time_frame":"Double-blind Treatment Phase: Weeks 2"},{"outcome_type":"secondary","measure":"Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).","time_frame":"Double-blind Treatment Phase: Weeks 3"},{"outcome_type":"secondary","measure":"Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).","time_frame":"Double-blind Treatment Phase: Weeks 4"},{"outcome_type":"secondary","measure":"Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).","time_frame":"Double-blind Treatment Phase: Weeks 5"},{"outcome_type":"secondary","measure":"Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).","time_frame":"Double-blind Treatment Phase: Weeks 6"},{"outcome_type":"secondary","measure":"Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).","time_frame":"Double-blind Treatment Phase: Weeks 7"},{"outcome_type":"secondary","measure":"Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).","time_frame":"Double-blind Treatment Phase: Weeks 8"},{"outcome_type":"secondary","measure":"Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).","time_frame":"Double-blind Treatment Phase: Weeks 9"},{"outcome_type":"secondary","measure":"Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).","time_frame":"Open-Label Phase: Weeks 16"},{"outcome_type":"secondary","measure":"Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).","time_frame":"Open-Label Phase: Weeks 20"},{"outcome_type":"secondary","measure":"Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.","time_frame":"Double-blind Treatment Phase: Weeks 1"},{"outcome_type":"secondary","measure":"Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.","time_frame":"Double-blind Treatment Phase: Weeks 2"},{"outcome_type":"secondary","measure":"Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.","time_frame":"Double-blind Treatment Phase: Weeks 3"},{"outcome_type":"secondary","measure":"Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.","time_frame":"Double-blind Treatment Phase: Weeks 4"},{"outcome_type":"secondary","measure":"Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.","time_frame":"Double-blind Treatment Phase: Weeks 5"},{"outcome_type":"secondary","measure":"Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.","time_frame":"Double-blind Treatment Phase: Weeks 6"},{"outcome_type":"secondary","measure":"Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.","time_frame":"Double-blind Treatment Phase: Weeks 7"},{"outcome_type":"secondary","measure":"Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.","time_frame":"Double-blind Treatment Phase: Weeks 8"},{"outcome_type":"secondary","measure":"Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.","time_frame":"Double-blind Treatment Phase: Weeks 9"},{"outcome_type":"secondary","measure":"Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.","time_frame":"Double-blind Treatment Phase: Weeks 10"},{"outcome_type":"secondary","measure":"Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.","time_frame":"Open-Label Phase: Weeks 2"},{"outcome_type":"secondary","measure":"Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.","time_frame":"Open-Label Phase: Weeks 4"},{"outcome_type":"secondary","measure":"Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.","time_frame":"Open-Label Phase: Weeks 8"},{"outcome_type":"secondary","measure":"Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.","time_frame":"Open-Label Phase: Weeks 12"},{"outcome_type":"secondary","measure":"Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.","time_frame":"Open-Label Phase: Weeks 16"},{"outcome_type":"secondary","measure":"Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.","time_frame":"Open-Label Phase: Weeks 20"},{"outcome_type":"secondary","measure":"Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events.","time_frame":"Screening/Baseline Phase: Baseline"},{"outcome_type":"secondary","measure":"Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events.","time_frame":"Double-blind Treatment Phase: Weeks 1"},{"outcome_type":"secondary","measure":"Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events.","time_frame":"Double-blind Treatment Phase: Weeks 2"},{"outcome_type":"secondary","measure":"Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events.","time_frame":"Double-blind Treatment Phase: Weeks 3"},{"outcome_type":"secondary","measure":"Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events.","time_frame":"Double-blind Treatment Phase: Weeks 4"},{"outcome_type":"secondary","measure":"Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events.","time_frame":"Double-blind Treatment Phase: Weeks 6"},{"outcome_type":"secondary","measure":"Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events.","time_frame":"Double-blind Treatment Phase: Weeks 7"},{"outcome_type":"secondary","measure":"Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events.","time_frame":"Double-blind Treatment Phase: Weeks 8"},{"outcome_type":"secondary","measure":"Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events.","time_frame":"Double-blind Treatment Phase: Weeks 9"},{"outcome_type":"secondary","measure":"Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events.","time_frame":"Double-blind Treatment Phase: Weeks 10"},{"outcome_type":"secondary","measure":"Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events.","time_frame":"Open-Label Phase: Weeks 2"},{"outcome_type":"secondary","measure":"Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events.","time_frame":"Open-Label Phase: Weeks 4"},{"outcome_type":"secondary","measure":"Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events.","time_frame":"Open-Label Phase: Weeks 8"},{"outcome_type":"secondary","measure":"Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events.","time_frame":"Open-Label Phase: Weeks 12"},{"outcome_type":"secondary","measure":"Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events.","time_frame":"Open-Label Phase: Weeks 16"},{"outcome_type":"secondary","measure":"Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events.","time_frame":"Open-Label Phase: Weeks 20"}]}
{"nct_id":"NCT01399515","start_date":"2011-03-31","phase":"Phase 2","enrollment":200,"brief_title":"Efficacy and Safety of Oral Valproic Acid for Retinitis Pigmentosa","primary_completion_date":"2013-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-11-30","last_update":"2016-04-14","description":"The purpose of this study is to evaluate the efficacy and safety of oral valproic acid to slow the progression of visual function and/or to improve the visual function in patients with retinitis pigmentosa (RP). Enrolled subjects in valproic acid group will be treated with oral valproic acid 500mg daily for 48 weeks. Visual function and safety will be assess before and after treatment (48 weeks) between valproic acid and control groups.","other_id":"SNUH_OT_VPA","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosis of retinitis pigmentosa (RP) established by night blindness, visual field\r\n             constriction, marked reduction of electroretinogram, and the clinical signs of RP in\r\n             fundus examination\r\n\r\n          -  Best corrected visual acuity of 20/200 or more on a Snellen chart in at least one eye\r\n\r\n          -  Intact visual field of 5 or more as measured by the kinetic perimetry\r\n\r\n          -  Understand and sign the IRB-approved informed consent document for the study\r\n\r\n          -  Body weight: male (40 kg to 100 kg), female (40 kg to 80 kg)\r\n\r\n          -  Must be able to swallow tablets\r\n\r\n          -  Female subjects of childbearing potential must commit to practice acceptable methods\r\n             of contraception\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnant women\r\n\r\n          -  Lactating mothers\r\n\r\n          -  Medical problems that make consistent follow-up over the treatment period unlikely\r\n             (e.g., stroke, myocardiac infarction, malignancy) or severe systemic disease\r\n\r\n          -  Other ocular disease: retinal disease other than RP or cystoid macular edema,\r\n             glaucoma, cataract worse than +2PSC or infectious corneal disease\r\n\r\n          -  Coagulation disorder or bleeding-tendency\r\n\r\n          -  Liver dysfunction\r\n\r\n          -  Renal dysfunction\r\n\r\n          -  History of pancreatitis\r\n\r\n          -  History of neurological disorders including epilepsy, history of brain injury or any\r\n             organic brain disorders\r\n\r\n          -  History of mental disorders including schizophrenia, bipolar disorder, or suicidality\r\n\r\n          -  Currently receiving valproic acid or other anti-convulsants\r\n\r\n          -  Has taken one of the following drugs at least 4 weeks prior to enrollment as these\r\n             drugs are specifically known to affect the progression of RP: vitamin A, lutein,\r\n             omega-3 fatty acid, or any antioxidant which affect the blood flow of retina or\r\n             retinal function.\r\n      ","sponsor":"Seoul National University Hospital","sponsor_type":"Other","conditions":"Retinitis Pigmentosa|Retinal Diseases|Eye Diseases|Eye Disease, Hereditary|Retinal Degeneration","interventions":[{"intervention_type":"Drug","name":"Drug: Valproic Acid","description":"One 500mg tablet by mouth daily"}],"outcomes":[{"outcome_type":"secondary","measure":"Mean change in fundus appearance","time_frame":"Baseline and week 48","description":"Fundus appearance as judged by color fundus photography"},{"outcome_type":"primary","measure":"Mean change in visual field area from baseline to 48 weeks","time_frame":"Baseline, week 24, and week 48","description":"Visual field area will be measured using kinetic perimetry (Goldmann perimetry) or static perimetry including the central 30 field."},{"outcome_type":"secondary","measure":"Mean change in best corrected visual acuity (BCVA)","time_frame":"Baseline, week 24, and week 48","description":"BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS)"},{"outcome_type":"secondary","measure":"Mean change in 30-Hz flicker Electroretinogram (ERG) amplitude","time_frame":"Baseline and week 48"},{"outcome_type":"secondary","measure":"Mean change in central macular thickness","time_frame":"Baseline, week 24, and week 48","description":"Central macular thickness as measured by Optical Coherence Tomography (OCT)"},{"outcome_type":"secondary","measure":"Mean change in total score on vision-related quality of life","time_frame":"Baseline and week 48","description":"Total score on vision-related quality of life as measured by the National Eye Institute Visual Function Questionnaire (NEI-VFQ25)"},{"outcome_type":"secondary","measure":"Occurrence of adverse effect related to Valproic acid","time_frame":"Baseline through 48 weeks"},{"outcome_type":"secondary","measure":"Changes in clinical laboratory data","time_frame":"Baseline through 48 weeks","description":"CBC, BUN, Creatinine, Liver panel (Cholesterol, Total protein, Albumin, Total bilirubin, Alkaline phosphatase, AST, ALT, GGT), Coagulation panel (PT INR, PT%, PT sec, aPTT, Fibrinogen), Electrolyte panel (Na, K, Cl, TCO2)"},{"outcome_type":"secondary","measure":"Mean change in central macular volume","time_frame":"Baseline, week 24, and week 48","description":"Central macular volume as measured by Optical Coherence Tomography (OCT)"}]}
{"nct_id":"NCT01551927","start_date":"2011-03-31","enrollment":754,"brief_title":"Patients Expectations for Future Examination and Treatment","official_title":"What Are the Expectations for Future Examination and Treatment in Patients Undergoing Evaluation and Treatment of Coronary Heart Disease?","primary_completion_date":"2014-01-31","study_type":"Observational","rec_status":"Completed","completion_date":"2014-02-28","last_update":"2014-02-19","description":"Aim: To investigate and compare women's and men's expectations before investigation and treatment of suspected coronary artery disease and to examine how these expectations are met. Do women and men, of different ages, have the same expectations for the evaluation and treatment of stable coronary artery disease and are their expectations met in a equal degree? Are there differences in expectations and the fulfilment of these according to age and other clinical history variables? Do the findings in the specially developed questionnaire designed to gather patients' expectations to the outcome on quality of life and degree of angina pectoris relate to their appearance in the designated forms? Is there a relationship between NTproBNP - levels, as a measure of cardiac workload, and expectations and the fulfilment of these as well as the quality of life and degree of angina pectoris? Method: Patients will be asked to participate in the study, in the context of medical consultation before coronary angiography by a physician and / or a study nurse. This occurs during an outpatient visit at the cardiac clinic at the respective centre. Included are all patients planned for elective coronary angiography before possible revascularization during a eight month period regardless of diagnosis. Including are four hospitals in the region of Vstra Gtaland.","other_id":"Dnr667-10","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"Patients planned for elective coronary angiography","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  <18 Years of Age.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Inability to communicate verbally or in writing.\r\n\r\n          -  Unwillingness to participate in the study.\r\n      ","sponsor":"Gteborg University","sponsor_type":"Other","conditions":"Coronary Heart Disease","interventions":{},"outcomes":{}}
{"nct_id":"NCT01277458","start_date":"2011-03-31","enrollment":0,"brief_title":"Ethnicity Data in HIV Positive Men Who Have Sex With Men","official_title":"Accuracy of Ethnicity Recording in MSM Patients With HIV of Non-White Ethnicity in London","primary_completion_date":"2011-03-31","study_type":"Observational","rec_status":"Withdrawn","completion_date":"2011-03-31","last_update":"2020-03-04","description":"Are there differences between the way that non-White men who have sex with men living in London with HIV describe their own ethnicity and the way in which their ethnic group is recorded in NHS clinics? We aim to describe the way in which clinics in London currently record a patient's ethnic group. Without accurate data for an individual's ethnic group we are unable to draw meaningful conclusions about their experiences of HIV care. It may be the case that patients from particular ethnic groups require specific ways of monitoring and treating their HIV but without knowing if these people are in a particular group any services directed to them may be wasted or underused.","other_id":"EthMSM01","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"Male","minimum_age":18,"population":"400 Non-White HIV positive Men who have sex with men","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients diagnosed with HIV\r\n\r\n          -  Male patients who have ever had sex with other men (bi- or homosexual to both be\r\n             included)\r\n\r\n          -  Patients of non-white ethnicity (patients described as being of \"mixed\" or \"other\"\r\n             ethnicity are to be included)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Female patients\r\n\r\n          -  Male patients who have only ever had sex with women\r\n\r\n          -  Patients whose ethnicity is described as \"White\"\r\n\r\n          -  Patients unable to read or understand the written questionnaire\r\n      ","sponsor":"Public Health England","sponsor_type":"Other","conditions":"HIV","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Proportion of misclassification of ethnicity for non-White MSM with HIV living in London","time_frame":"end of study (2 months)"},{"outcome_type":"secondary","measure":"• Prevalence of individual non-White self-identified ethnicity groups in MSM with HIV in London","time_frame":"End of study (2 months)"},{"outcome_type":"secondary","measure":"Description of current clinic practice for ethnicity data recording","time_frame":"End of study (2 months)"}]}
{"nct_id":"NCT01376583","start_date":"2011-03-31","enrollment":10,"brief_title":"Exercise Controls Tumor Cell Growth Through AMPK Activation","official_title":"Running From Cancer","primary_completion_date":"2013-12-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2013-12-31","last_update":"2013-12-02","description":"The study investigates the explanation for the positive relation found between exercise and breastcancer.","other_id":"VEK-H-3-2010-141","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"Female","minimum_age":18,"maximum_age":30,"population":"Healthy Danish females in the age 18-30","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy Females age 18-30\r\n\r\n          -  BMI 18-25\r\n\r\n          -  Regular period\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Ingestions of any hormones\r\n\r\n          -  Pregnancy\r\n\r\n          -  Chronic inflammation\r\n\r\n          -  Elite athletes\r\n      ","sponsor":"Rigshospitalet, Denmark","sponsor_type":"Other","conditions":"Breast Cancer","interventions":{},"outcomes":{}}
{"nct_id":"NCT01382810","start_date":"2011-03-31","phase":"Phase 4","enrollment":100,"brief_title":"Altaire Gel Forming Solution Versus Refresh Tears for the Treatment of Dry Eye Signs and Symptoms","official_title":"A Randomized Masked Evaluation of Altaire Gel Forming Solution Versus Refresh Tears for the Treatment of Dry Eye Signs and Symptoms","primary_completion_date":"2012-10-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2012-10-31","last_update":"2012-06-14","description":"The purpose of this study is to evaluate and compare the effects of Altaire Gel forming solution and Refresh Tears in mild-moderate dry eye patients.","other_id":"Altaire2011","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients 18 years or older.\r\n\r\n          -  Males or females.\r\n\r\n          -  Patient reported dry eye symptoms (episodic, annoying, activity limiting).\r\n\r\n          -  Physician assessment of mild-moderate dry eye.\r\n\r\n          -  Patient willing to instill drops TID and complete entire length of protocol.\r\n\r\n          -  TBUT _< 10 seconds.\r\n\r\n          -  At least Grade 6 Corneal Staining.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Current topical cyclosporine use (Restasis)\r\n\r\n          -  Current Refresh use.\r\n\r\n          -  Refractive surgery within the last 6 months.\r\n\r\n          -  Oral or topical corticosteroid use.\r\n\r\n          -  Severe dry eye patients by physician assessment.\r\n\r\n          -  Current active blepharitis.\r\n\r\n          -  Oral doxycycline use.\r\n\r\n          -  Oral antihistamine use.\r\n      ","sponsor":"Innovative Medical","sponsor_type":"Industry","conditions":"Dry Eye Syndromes","interventions":[{"intervention_type":"Drug","name":"Drug: Altaire Gel forming solution","description":"Three times a day for two months"},{"intervention_type":"Drug","name":"Drug: Refresh Tears","description":"Three times a day for two months"}],"outcomes":[{"outcome_type":"primary","measure":"TBUT","time_frame":"2 months","description":"Test performed that measures how long the tears take to break up"},{"outcome_type":"primary","measure":"Conjunctival and Corneal staining","time_frame":"2 months","description":"Dye that will be placed inside the eye to evaluate the surface of the ey"}]}
{"nct_id":"NCT01479829","start_date":"2011-03-31","phase":"Phase 4","enrollment":88,"brief_title":"Bipolar Depression and Inflammation","official_title":"Cyclooxygenase-2-Inhibitor Combination Treatment for Bipolar Depression: Role of Inflammation and Kynurenine Pathway Biomarkers","primary_completion_date":"2019-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-03-31","last_update":"2019-03-04","description":"This project will attempt to enhance and augment the antidepressant efficacy of a commonly used antidepressant in poorly responding bipolar depressed patients.","other_id":"203368","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":21,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Ages 21 - 65 years old at time of screening visit. Both genders and any race will be\r\n             accepted.\r\n\r\n          -  Diagnosis of BPD I or II without significant co-morbid secondary medical or\r\n             psychiatric diagnoses; no substance abuse or dependence during preceding 12 months\r\n\r\n          -  A minimum score of 18 on the first 17 items of the 21-item Hamilton Depression Scale\r\n\r\n          -  Willingness to washout for a reasonable time (depending on the substance) from:\r\n             Vitamin E and fish oils (>600 IU/day), non-aspirin NSAIDs or aspirin (>81 mg/day, H2\r\n             receptor antagonists, Ginko biloba, caffeine on morning of blood drawing, and to\r\n             institute lights-out at 23:00 hours on the nights before blood drawings\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any abnormal findings on the physical exam, ECG, blood/urine or minor infections\r\n\r\n          -  Any pre-existing physical pain condition, including fibromyalgia\r\n\r\n          -  History of peptic ulcer complicated by perforation, hemorrhage, or obstruction;\r\n             symptoms of peptic ulcer within 4 weeks of enrollment date\r\n\r\n          -  Any substance abuse or dependence during the preceding 12 months\r\n\r\n          -  Clinically significant hypertension, anemia, liver disease, kidney disease, arthritis,\r\n             diabetes, recurrent migraines, epilepsy, stroke, gum disease, autoimmune disease\r\n\r\n          -  Current use of lithium\r\n\r\n          -  Current use of a stimulant\r\n\r\n          -  Certain steroids including use of hormonal birth control and any systemic or topical\r\n             corticosteroids (hormone replacement therapy will be allowed)\r\n\r\n          -  Unwillingness to refrain from H2 receptor antagonists, non-aspirin NSAIDs, or aspirin\r\n             (mor than 1 mg/day).\r\n\r\n          -  Use of any anticoagulant agents\r\n\r\n          -  Use of nicotine-containing substances. Subjects who quit smoking more than 3 months\r\n             prior to assessment may be considered for the study\r\n\r\n          -  Known sensitivity or allergy to the study medications or a need to receive agents that\r\n             are contra-indicated in combination with CBX or ESC\r\n\r\n          -  Unwillingness to fast and abstain from caffeine on mornings of blood drawings\r\n\r\n          -  A sleep disorder other than insomnia or hypersomnia as a distinct symptom of MDD\r\n\r\n          -  Inability to commit to the follow-up visits between 8 and 11 am\r\n      ","sponsor":"Loyola University","sponsor_type":"Other","conditions":"Bipolar Depression","interventions":[{"intervention_type":"Drug","name":"Drug: ESC + CBX","description":"Escitalopram (ESC) 10 mg twice day given orally twice a day plus Celecoxib (CBX) 200 mg twice daily."},{"intervention_type":"Drug","name":"Drug: ESC + PBO.","description":" Escitalopram (ESC) 10 mg twice per day plus Placebo (PBO)administered twice daily."},{"intervention_type":"Drug","name":"Drug: ESC+CBX","description":" Escitalopram 10 mg given twice day plus Celecoxib 200 mg twice daily."}],"outcomes":[{"outcome_type":"primary","measure":"Improved affective responses","time_frame":"8 weeks","description":"combined pharmacotherapy of ESC + CBX will result in earlier and/or improved affective responses compared to ESC + placebo measured by rating three levels of assessment of clinical improvement: (a) time of onset of mood response, (b) magnitude of mood response, and (c) prevalence and time point of symptom remission"},{"outcome_type":"secondary","measure":"Safety profile of combined ESC/CBX therapy","time_frame":"8 weeks","description":"Determine whether combined pharmacotherapy of ESC + CBX poses safety or tolerability issues, particularly in terms of gastrointestinal bleeding or cardiovascular health over a 8-week course of treatment."}]}
{"nct_id":"NCT01050777","start_date":"2011-03-31","phase":"Early Phase 1","enrollment":30,"brief_title":"Efficacy of Topical Liposomal Form of Drugs in Cutaneous Leishmaniasis","official_title":"Pilot Study of Efficacy of Topical Nano-liposomal Meglumine Antimoniate (Glucantime) or Paromomycin in Combination With Systemic Glucantime for the Treatment of Anthroponotic Cutaneous Leishmaniasis (ACL) Caused by Leishmania Tropica","primary_completion_date":"2012-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-03-31","last_update":"2012-06-20","description":"Leishmaniasis with diverse clinical manifestations is caused by different species of Leishmania and is endemic in many countries. Although Cutaneous Leishmaniasis (CL) is a self-healing disease, but it takes a long time to heal. Pentavalent antimonials are still the first-line treatment of CL which needs multiple injections, are painful and as such not tolerated by most of the patients, in addition available treatments are not always effective and resistance is reported. Paromomycin sulfate (PM) reported to show anti-Leishmania activity against both CL and visceral leishmaniasis (VL) since 1960s. Therapeutic strategy with high efficacy is urgently needed especially for Anthroponotic Cutaneous Leishmaniasis (ACL). Liposomes are lipid bilayer molecules which entrap water-soluble molecules in their internal water compartment and water-insoluble ones into their lipid bilayers. Liposomes, in proper formulations and sizes, deliver drugs to the skin based on the similarity of the bilayers structure of lipid vesicles to that of natural membrane and target the macrophages within dermis. Several lipid-based formulations have been developed to treat experimental leishmaniasis. Recently different doses of liposomal formulation of PM and liposomal formulation of Glucantime were prepared and showed high efficacy in vivo against L. major infection in BALB/c mice. In this study the efficacy of liposomal formulation of PM or liposomal formulation of Glucantime in combination with systemic Glucantime in the treatment of ACL parasitologically proven patients will be evaluated. The clinical trial will be carried out according to the International approved GCP (Good Clinical Practice) guide lines.","other_id":"86783","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":12,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female aged between 12 to 60 years.\r\n\r\n          -  Parasitologically proven CL due to L. tropica.\r\n\r\n          -  History of failure to at least one full course of systemic Glucantime.\r\n\r\n          -  In general good health based on history and physical examination.\r\n\r\n          -  Number of lesion at most 4.\r\n\r\n          -  Lesion size less than 3 cm.\r\n\r\n          -  Signed informed consent voluntarily and knowingly.\r\n\r\n               -  Guardian's signature for volunteer less than 18 years old.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnant or lactating women and those who are planning to be pregnant in next 60 days.\r\n\r\n          -  Use of other types of treatment for CL.\r\n\r\n          -  Involvement in any other drug or vaccine trial during the study period.\r\n\r\n          -  Known heart, kidney, liver diseases based on history and physical exam. Abnormal ECG.\r\n      ","sponsor":"Tehran University of Medical Sciences","sponsor_type":"Other","conditions":"Cutaneous Leishmaniasis","interventions":[{"intervention_type":"Drug","name":"Drug: Liposomal meglumine antimoniate (Glucantime)","description":"Liposomes containing meglumine antimoniate"},{"intervention_type":"Drug","name":"Drug: Liposomal meglumine antimoniate","description":"Liposomal form of meglumine antimoniate"},{"intervention_type":"Drug","name":"Drug: Liposomal Paromomycin","description":"Liposomal form of 10% Paromomycin"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"Complete cure equal to Complete Re-epithelization of all lesions","time_frame":"200 days"}]}
{"nct_id":"NCT01918150","start_date":"2011-03-31","phase":"Phase 4","enrollment":1350,"brief_title":"Comparative Phase IV Study: Efficacy And Safety of TiTAN2 Versus COBALT-CHROME Stents- EVIDENCEII","official_title":"A French, Multicentric, Randomized, Simple Blind, Superiority Study Comparing the Efficiency and the Safety at 24 Months of the Stent Titan2 Versus Bare Metal Stent in Cobalt-Chrome in All Comers Patients Among Which 40 % Present an ACS.","primary_completion_date":"2015-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2016-03-31","last_update":"2014-01-08","description":"The purpose of this study is to compare the effectiveness and safety, at 24 months, of the TITAN2 stent to any bare-metal stent (BMS) in Cobalt-Chromium in a population presenting an indication for these stents among 40% of which present an acute coronary syndrome (ACS).","other_id":"HXF-CT2-20111","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patient with symptomatic de novo coronary lesion involving one or two vessels\r\n\r\n          -  Patient presenting a lesion with > 50% stenosis\r\n\r\n          -  Patient who must undergo a percutaneous coronary intervention (PCI) in the indications\r\n             of Cobalt-chromium bare metal stents and TITAN2 stents and being able to be\r\n             indifferently treated with one or the other of these stents.\r\n\r\n          -  Written informed consent\r\n\r\n          -  Expected survival > 2 years\r\n\r\n          -  Patient reachable by phone throughout the duration of the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnant/Lactating women\r\n\r\n          -  Women of childbearing potential (last menstrual period <12 months) not using effective\r\n             contraception\r\n\r\n          -  Patient under legal protection\r\n\r\n          -  Indication of coronary artery bypass graft surgery (CABG)\r\n\r\n          -  History of coronary artery bypass graft surgery (CABG)\r\n\r\n          -  Intrastent restenosis lesion\r\n\r\n          -  Bifurcation lesion with the exception of those treated with a standardized approach\r\n             (provisional stenting with final kissing in the side branch)\r\n\r\n          -  Left main coronary lesion\r\n\r\n          -  Ostial target lesion\r\n\r\n          -  Previous drug-eluting stenting\r\n\r\n          -  Previous bare metal stenting or balloon angioplasty in the 12 months prior the\r\n             inclusion; if this implantation involved the target artery, separate the new implanted\r\n             stent at a distance  10 mm.\r\n\r\n          -  History of stent thrombosis\r\n\r\n          -  Heavily calcified lesion\r\n\r\n          -  Use of the Rotablator\r\n\r\n          -  Left ventricular ejection fraction (LVEF) < 30%\r\n\r\n          -  Cardiac arrest, cardiogenic shock or severe heart failure (Killip stage III or IV)\r\n\r\n          -  Severe chronic renal failure (creatinine clearance <30 ml min)\r\n\r\n          -  Cardiac or renal transplantation\r\n\r\n          -  Major surgery within the last 14 days\r\n\r\n          -  Surgery scheduled within 30 days (non-ACS patients) or 12 months (if ACS) at the time\r\n             of the randomization\r\n\r\n          -  History of major bleeding\r\n\r\n          -  Pathology with major risk of bleeding or any condition, allergy or intolerance which\r\n             is incompatible with anticoagulation and / or extended antiplatelet therapy\r\n\r\n          -  Known allergy to Titanium, Nickel, Cobalt or Chromium\r\n\r\n          -  Patient currently participating in another clinical trial\r\n\r\n          -  Non-compliant patient (treatment and follow-up)\r\n\r\n          -  Patient living abroad\r\n      ","sponsor":"Hexacath, France","sponsor_type":"Industry","conditions":"Silent Myocardial Infarction|Stable Angina|Acute Coronary Syndrome","interventions":[{"intervention_type":"Device","name":"Device: Cobalt-Chromium Bare Metal Stents","description":"The intervention is called Percutaneous Coronary Intervention (PCI); Commonly known as coronary angioplasty or simply angioplasty, it is a non-surgical procedure used to treat the stenotic (narrowed) coronary arteries of the heart found in coronary heart disease. PCI is usually performed by an interventional cardiologist."},{"intervention_type":"Device","name":"Device: Titan 2 stents","description":"The intervention is called Percutaneous Coronary Intervention (PCI); Commonly known as coronary angioplasty or simply angioplasty, it is a non-surgical procedure used to treat the stenotic (narrowed) coronary arteries of the heart found in coronary heart disease. PCI is usually performed by an interventional cardiologist."}],"outcomes":[{"outcome_type":"primary","measure":"MACE","time_frame":"24 months","description":"The primary endpoint (MACE) is the composite of cardiac death, (Myocardial Infarction) MI and target lesion revascularization (TLR).\r\nThese events will be collected post-procedure during the patient's hospitalization and at 6 , 12 and 24 month follow-up."},{"outcome_type":"secondary","measure":"Medico economic evaluation","time_frame":"24 months","description":"Data collection of acts and diagnosis specific codes related to any adverse event with hospitalization in relation with the endoprothesis allocated.\r\nIt will be then analyzed by an dedicated expert who will be able to appreciate a cost/efficiency rate for each treatment arm."},{"outcome_type":"secondary","measure":"Target Lesion Revascularization (TLR ) rate","time_frame":"24 months","description":"Any study stent restenosis leading to a procedure or a surgery to treat it."},{"outcome_type":"secondary","measure":"Stent thrombosis rate","time_frame":"24 months","description":"Stent thrombosis will be evaluated as per the ARC classification (ie degree of evidence and time to event)"},{"outcome_type":"secondary","measure":"Success of the procedure","time_frame":"24 months","description":"Defined as an efficient reintroduction of the blood flow in the target vessel post angioplasty.\r\nIt's a \"YES/NO\" question."}]}
{"nct_id":"NCT02132689","start_date":"2011-03-31","phase":"Phase 4","enrollment":100,"brief_title":"Comparison of Thrombgolytic and Anticoagulation Therapy in Submassive Pulmonary Embolism","official_title":"Comparison of Thrombgolytic and Anticoagulation Therapy in Submassive Pulmonary Embolism in Context of Pulmonary Hypertension, Right Heart Failure and Patient Functional Ability","primary_completion_date":"2015-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-12-31","last_update":"2018-03-19","description":"Currently there is no clear guidance for the treatment of moderate risk of pulmonary embolism. The aim of the study is to compare two different therapeutic modalities - standard anticoagulation versus thrombolytic treatment followed by anticoagulation in standard regimen as stated in the pulmonary embolism guidelines.","other_id":"FNO-KVO-3","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  moderate risk pulmonary embolism as defined by the European Society of Cardiology\r\n             /ESC/ guidelines\r\n\r\n          -  signed informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  patient not willing to sigh informed consent\r\n\r\n          -  absolute contraindication of thrombolysis\r\n\r\n          -  inability to obtain meaningfull echocardiographic images\r\n\r\n          -  pulmonary arterial hypertension\r\n\r\n          -  known right ventricular failure\r\n      ","sponsor":"University Hospital Ostrava","sponsor_type":"Other","conditions":"Pulmonary Embolism","interventions":[{"intervention_type":"Drug","name":"Drug: Actilyse (Thrombolytic therapy)"},{"intervention_type":"Drug","name":"Drug: Heparine (Standard anticoagulation therapy)"}],"outcomes":[{"outcome_type":"primary","measure":"Clinical manifestations of right ventricular failure and pulmonary hypertension and cardiovascular-related death","time_frame":"12 months","description":"The primary outcome of the study is to follow clinical manifestations of right ventricular failure (assessed according to the New York Heart Association /NYHA/ classification)."},{"outcome_type":"primary","measure":"Pulmonary hypertension","time_frame":"12 months","description":"The primary outcome of the study is to follow pulmonary hypertension (measured in mmHg)."},{"outcome_type":"primary","measure":"Cardiovascular-related deaths","time_frame":"12 months","description":"The primary outcome of the study is to follow the number of cardiovascular-related deaths within the time frame of 12 months."},{"outcome_type":"secondary","measure":"Echocardiographic manifestations of right ventricular failure and pulmonary hypertension.","time_frame":"12 months","description":"The secondary outcome measure of the study is to follow echocardiographic manifestations of right ventricular failure (TdiSm)."}]}
{"nct_id":"NCT01333397","start_date":"2011-03-31","phase":"Phase 2","enrollment":176,"brief_title":"Safety and Efficacy Study of Dysport RU and Glabellar Lines","official_title":"A Phase II, Double Blind, Randomised, Placebo and Active Comparator Controlled Study to Assess the Safety and Efficacy of Three Doses of Dysport RU (20 U, 50 U, and 75 U) Administered as a Single Treatment Cycle to Improve the Appearance of Moderate to Severe Glabellar Lines","primary_completion_date":"2011-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-09-30","last_update":"2019-08-06","description":"The primary objective is to assess the dose response versus placebo of a single treatment of Dysport RU (Dysport RU, Ready to Use, for injection), for the improvement in appearance of moderate to severe glabellar lines at maximum frown.","other_id":"Y-52-52120-146","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"Female","minimum_age":30,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Female between 30 - 60 years of age\r\n\r\n          -  Moderate to severe vertical glabellar lines at maximum frown at baseline\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Silicone injections into the upper face\r\n\r\n          -  Any prior treatment with fillers (e.g. collagen-type implants) skin abrasions or\r\n             photorejuvenation within the previous 12 months\r\n\r\n          -  Any planned facial cosmetic surgery during the study period\r\n\r\n          -  A history of ablative skin resurfacing of the area to be treated during the study.\r\n      ","sponsor":"Ipsen","sponsor_type":"Industry","conditions":"Glabellar Frown Lines","interventions":[{"intervention_type":"Biological","name":"Biological: Botulinum toxin type A","description":"I.M. on day 1 (single treatment cycle)"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"I.M. on day 1 (single treatment cycle)"},{"intervention_type":"Biological","name":"Biological: Botulinum toxin type A","description":"I.M. (in the muscle) injection on day 1 (single treatment cycle)"}],"outcomes":[{"outcome_type":"secondary","measure":"Percentage of Subjects as Responders at Maximum Frown on Day 29 Who Remain Responders","time_frame":"Day 113","description":"A responder at maximum frown was defined as a subject having a severity grade of none or mild at maximum frown on the visit day and a severity grade of moderate or severe at maximum frown at Visit 2."},{"outcome_type":"primary","measure":"Percentage of Subjects as Responders in the ILA (Using Validated 4-point Photographic Scale) and the SSA of Glabellar Lines at Maximum Frown","time_frame":"Day 29","description":"Investigator's live assessment (ILA), subject's self assessment (SSA), Next Generation (NG)\r\n4-point photographic scale: Investigator's live assessment: None - 0; Mild - 1; Moderate - 2; Severe - 3;\r\n4-point photographic scale: Subject's Self assessment: No wrinkles - 0; Mild wrinkles - 1; Moderate wrinkles - 2; Severe wrinkles - 3;\r\nA responder at maximum frown was defined as a subject having a severity grade of none or mild at maximum frown on Day 29 and a severity grade of moderate or severe at maximum frown at Visit 2."},{"outcome_type":"secondary","measure":"Percentage of Subjects as Assessed as Responders, by Both Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown.","time_frame":"Day 29","description":"A responder at maximum frown was defined as a subject having a severity grade of none or mild at maximum frown on the visit day and a severity grade of moderate or severe at maximum frown at Visit 2."},{"outcome_type":"secondary","measure":"Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment.","time_frame":"Days 8, 15, 57, 85 and 113"},{"outcome_type":"secondary","measure":"Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment.","time_frame":"Days 8, 15, 57, 85 and 113"},{"outcome_type":"secondary","measure":"Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown.","time_frame":"Days 8, 15, 57, 85 and 113"},{"outcome_type":"secondary","measure":"Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment.","time_frame":"Days 8, 15, 29, 57, 85 and 113","description":"A responder at rest was defined as a subject having a severity grade of none or mild at rest on the visit day and a severity grade of moderate or severe at rest at Visit 2."},{"outcome_type":"secondary","measure":"Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Maximum Frown as Measured by the Investigator's Live Assessment","time_frame":"Days 8, 15, 29, 57, 85 and 113","description":"A reduction of two or more grades in the severity of glabellar lines at maximum frown was a change from Visit 2 severity of glabellar lines from severe to mild/none or from Visit 2 severity of moderate to none after treatment as measured by the Investigator's live assessment"},{"outcome_type":"secondary","measure":"Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Rest as Measured by the Investigator's Live Assessment","time_frame":"Days 8, 15, 29, 57, 85 and 113","description":"A reduction of two or more grades in the severity of glabellar lines at rest was a change from Visit 2 severity of glabellar lines from severe to mild or from Visit 2 severity of moderate to none after treatment as measured by the Investigator's live assessment."},{"outcome_type":"secondary","measure":"Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Maximum Frown as Measured by the Subject's Self-assessment","time_frame":"Days 8, 15, 29, 57, 85 and 113","description":"A reduction of two or more grades in the severity of glabellar lines at maximum frown was a change from Visit 2 severity of glabellar lines from severe to mild/no wrinkles or from Visit 2 severity of moderate to no wrinkles after treatment as measured by the subjects self assessment."},{"outcome_type":"secondary","measure":"Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U)","time_frame":"Days 8, 15, 29, 57, 85 and 113"},{"outcome_type":"secondary","measure":"Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U)","time_frame":"Days 8, 15, 29, 57, 85 and 113"},{"outcome_type":"secondary","measure":"Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U)","time_frame":"Days 8, 15, 29, 57, 85 and 113"},{"outcome_type":"secondary","measure":"Percentage of Subjects as Responders at Day 29 by the Investigator's Live Assessment and by Subject's Self Assessment of Glabellar Lines at Maximum Frown (Assay Sensitivity)","time_frame":"Day 29"},{"outcome_type":"other","measure":"Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study","time_frame":"Up to Day 113 (±3 days)","description":"Treatment Emergent Adverse Event (TEAE)"}]}
{"nct_id":"NCT01302535","start_date":"2011-03-31","phase":"N/A","enrollment":83,"brief_title":"The Impact of Yoga on Blood Pressure and Quality of Life in Patients With Hypertension","official_title":"The Impact of Yoga on Blood Pressure and Quality of Life in Patients With Hypertension - a Randomised Controlled Trial in Primary Health Care","primary_completion_date":"2011-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-06-30","last_update":"2012-02-23","description":"The purpose of this study is to determine the effects of yoga on blood pressure and quality of life in patients in primary health care diagnosed with hypertension within the last year. Another purpose is to examine whether the possible effect on blood pressure differs if patients practice yoga in a group lead by a yoga-trainer or receive a few yoga-exercises from their doctor to be practiced individually at home.","other_id":"2010/728","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosed with hypertension since at least one year.\r\n\r\n          -  Blood pressure 120/80-160/100 mmHg at the last blood pressure control by doctor or\r\n             nurse.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Blood pressure >180 systolic and/or >110 diastolic by the initial control in the\r\n             study.\r\n\r\n          -  Blood pressure <120 systolic by the initial control in the study.\r\n\r\n          -  Medical adjustments regarding hypertension within 4 weeks prior to begin of study.\r\n\r\n          -  Expected inability to understand instructions about yoga exercises (e.g dementia and\r\n             mental retardation) or physical or psychical inability to carry out yoga exercises\r\n             (e.g severe physical or psychical handicap).\r\n\r\n          -  Need for interpreter. Linguistic/language difficulties\r\n\r\n          -  Older than 80 years\r\n      ","sponsor":"Region Skane","sponsor_type":"Other","conditions":"Hypertension","interventions":[{"intervention_type":"Other","name":"Other: Yoga group with supervision (trainer)","description":"The Yoga-with-trainer group will meet once a week (60 minutes) to practice yoga with a yoga instructor. The participants will be encouraged to practice yoga between the yoga classes at home for 30 minutes a day."},{"intervention_type":"Other","name":"Other: Yoga at home","description":"The participants in the Yoga-at-home group will get a private doctor appointment (20 minutes) where they get instructions for two yoga exercises which they are encouraged to perform at home 15 minutes a day."}],"outcomes":[{"outcome_type":"primary","measure":"Hypertension","time_frame":"12 weeks","description":"At the beginning of the study, all subjects will undergo a standardized blood pressure test with an hypertension monitor. After 12 weeks, all subjects in the intervention and control groups will again be requested to attend a blood pressure testing session. Blood samples will also be collected and analysed in the beginning and at the end of the study. Some blood samples will be preserved for future analysis."},{"outcome_type":"secondary","measure":"Quality of life","time_frame":"12 weeks","description":"At the beginning of the study, all subjects will be requested to fill in a questionnaire about their quality of life (WHOQOL-BREF). After 12 weeks all subjects in the intervention and control groups will fill in the quality of life-form for a second time."}]}
{"nct_id":"NCT03485508","start_date":"2011-03-11","enrollment":150,"brief_title":"The Brugada Syndrome: a Follow-up Study","official_title":"Imaging and Risk Stratification in the Brugada Syndrome: a Follow-up Study","primary_completion_date":"2018-09-30","study_type":"Observational","rec_status":"Unknown status","completion_date":"2019-07-31","last_update":"2018-04-02","description":"Although for many years the Brugada syndrome has been labelled as a purely electrical disease in the structurally normal heart, the evolution of imaging techniques has enabled the discovery of subtle morphofunctional alterations in some of the Brugada syndrome patients. We will use new echocardiographic techniques to assess cardiac function in these patients and new parameters will be evaluated for their prognostic value as risk stratificators.","other_id":"2017/253","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Brugada syndrome patients visiting the UZ Brussel for diagnosis or follow-up.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18 years or older\r\n\r\n          -  Diagnosis of Brugada syndrome\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  history of pericarditis, ischemic heart disease, cardiomyopathy of any origin,\r\n             structural heart disease, or any other channelopathy\r\n      ","sponsor":"Universitair Ziekenhuis Brussel","sponsor_type":"Other","conditions":"Brugada Syndrome","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Transthoracic echocardiography","description":"Transthoracic echocardiography Blood sample with assessment of biomarkers"}],"outcomes":[{"outcome_type":"primary","measure":"Composed outcome of sudden cardiac death, appropriate ICD shock and witnessed ventricular fibrillation","time_frame":"6 years","description":"Sudden cardiac death is death occuring within 24 hours after being seen in a healthy status or within 1 hour after initiation of symptoms."},{"outcome_type":"secondary","measure":"Syncope","time_frame":"6 years","description":"Loss of consciousness"}]}
{"nct_id":"NCT01181154","start_date":"2011-03-03","phase":"Phase 3","enrollment":32,"brief_title":"Rituximab in Auto-Immune Hemolytic Anemia","official_title":"Rituximab in Adult's Warm Auto-Immune Hemolytic Anemia : a Phase III, Double-bind, Randomised Placebo-controlled Trial","primary_completion_date":"2015-01-08","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-01-08","last_update":"2017-10-19","description":"The hypothesis based on retrospective data is that, the rate of overall response-rate (PR + CR) at 1 year will be much higher in the rituximab arm (80%) than in the placebo arm (20%).Thirty four patients (17 in each arm) will be include (amendment n6 - 15/10/2013) over a 3 year period (amendment n3 - 11/12/2012).","other_id":"P080704","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age > 18 years\r\n\r\n          2. AIHA defined at time of diagnosis by a Hgb level  10 g/dL, with a reticulocytes count\r\n             > 120 109/L, signs of hemolysis (at least a haptoglobin level < 4 mg/L), and a\r\n             positive direct antiglobulin test (DAT) ( IgG or IgG + complement pattern).\r\n\r\n          3. Disease duration equal or less than 6 weeks at time of inclusion --> removed by\r\n             amendment n4 and substituted by :First episode of AIHA to \"hot\" antibody previously\r\n             untreated or treated corticosteroids for less than 6 weeks.\r\n\r\n          4. Patients with an associated autoimmune thrombocytopenia (Evans' syndrome) will be\r\n             eligible for the study if the platelet count is over 30 x 109/L at inclusion.\r\n\r\n          5. Normal level gammaglobulins in the serum (i.e. >5g/L) at inclusion.\r\n\r\n          6. Absence of detectable lymph nodes on a total body CT-scan (to be performed before\r\n             inclusion if not performed at diagnosis).\r\n\r\n          7. Effective means of contraception during treatment and for six months after completion\r\n             of treatment for all women of child bearing age\r\n\r\n          8. Negative serum pregnancy test within 14 days prior to study entry.\r\n\r\n          9. Written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n        Previous treatment with rituximab\r\n\r\n          1. AIHA diagnosed and treated more than 6 weeks prior to inclusion removed by amendment\r\n             n4 and substituted by AIHA relapsed or newly diagnosed but treated with\r\n             corticosteroids for more than 6 weeks\r\n\r\n          2. Ongoing immunosuppressive therapy (other than corticosteroids) or previous treatment\r\n             administered within 2 weeks prior to the beginning of the study treatment\r\n\r\n          3. Non-Hodgkin Lymphoma (NHL) other than stage A chronic lymphoid leukemia\r\n\r\n          4. Previous or concomitant malignancy other than basal cell or squamous cell carcinoma of\r\n             the skin, carcinoma-in-situ of the cervix, or other malignancy for which the patient\r\n             had not been disease-free for at least 5 years.\r\n\r\n          5. Autoimmune disorder such as SLE with at least one extra-hematological manifestation\r\n             requiring a treatment with steroids and/or immunosuppressive drugs.\r\n\r\n          6. Any other associated cause congenital or acquired hemolytic anemia (except thalassemia\r\n             trait or heterozygous sickle cell anemia).\r\n\r\n          7. Negative DAT or DAT positive with isolated anti-C3d pattern related to the presence of\r\n             a monoclonal IgM with cold agglutinin properties.\r\n\r\n          8. Positive HIV test and/or hepatitis virus C infection and/or positive hepatitis B virus\r\n             surface antigen (HbsAg).\r\n\r\n          9. Neutrophils count < 1,000/mm 3 at inclusion.\r\n\r\n         10. Impaired renal function as indicated by a serum creatinine level > 2 mg/d\r\n\r\n         11. Inadequate liver function as indicated by a total bilirubin level > 2.0 mg/dL and/or\r\n             an AST or ALT level > 2x upper limit of normal.\r\n\r\n         12. New York Heart Classification III or IV heart disease.\r\n\r\n         13. Previous history of severe psychiatric disorder or are unable to comply with study and\r\n             follow-up procedures\r\n\r\n         14. Pregnant or lactating women, or woman planning to become pregnant within 12 months of\r\n             receiving study drug\r\n\r\n         15. Absence of written informed consent.\r\n      ","sponsor":"Assistance Publique - Hpitaux de Paris","sponsor_type":"Other","conditions":"Warm Autoimmune Hemolytic Anemia","interventions":[{"intervention_type":"Drug","name":"Drug: rituximab (Mabthera)","description":"1000 mg at day 1 and day 15"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"equivalent volume total"}],"outcomes":[{"outcome_type":"secondary","measure":"Comparison in both arms of the number of patients requiring a splenectomy and/or an immunosuppressor","time_frame":"during the first 12 months of follow-up"},{"outcome_type":"secondary","measure":"Comparison in both arm of the mortality","time_frame":"at 1 year"},{"outcome_type":"secondary","measure":"Comparison in both arm of overall response (CR + PR)","time_frame":"at 2 years"},{"outcome_type":"primary","measure":"Overall response rate (complete and partial response) in both arms","time_frame":"at 1 year"},{"outcome_type":"secondary","measure":"Comparison in both arms of the mean cumulative doses of prednisone","time_frame":"at 1 year"},{"outcome_type":"secondary","measure":"Comparison in both arms of the number of transfusions of packed red blood cells in both arms","time_frame":"at 1 year"},{"outcome_type":"secondary","measure":"Comparison in both arms of the number of days in hospital","time_frame":"within the first year of follow-up"},{"outcome_type":"secondary","measure":"Comparison of the incidence of serious side effects in both arms","time_frame":"at 1 year"}]}
{"nct_id":"NCT01296230","start_date":"2011-02-28","phase":"N/A","enrollment":3,"brief_title":"Varicocelectomy: Can Sex-hormones Predict Improvements in Semen Quality?","official_title":"Varicocelectomy: Can Sex-hormones Predict Improvements in Semen Quality?","primary_completion_date":"2017-02-28","study_type":"Interventional","rec_status":"Terminated","completion_date":"2017-02-28","last_update":"2013-05-24","description":"The purpose of this study is to determine if the pre-operative levels of sex-hormones can be used to identify the varicocele patients who can expect improvements in their semen parameters following varicocelectomy.","other_id":"H-2-2010-067","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Varicocele (grade 1-3) and surgery planned for this condition\r\n\r\n          -  At least 18 years of age\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Fever within 3 months before the first semen sample\r\n\r\n          -  Malformations of the uro-genital tract\r\n\r\n          -  Karyotype other than 46, XY or Y micro deletions\r\n\r\n          -  Endocrine disease\r\n\r\n          -  Chronic disease\r\n\r\n          -  Medications which reduce semen quality\r\n\r\n          -  Epididymitis within 6 months before surgery\r\n      ","sponsor":"Copenhagen University Hospital at Herlev","sponsor_type":"Other","conditions":"Varicocele|Infertility|Semen Quality","interventions":[{"intervention_type":"Procedure","name":"Procedure: Hormone and semen measurements before varicocelectomy","description":"Before surgery we will measure sex-hormone levels and semen parameters. This will be repeated after the varicocelectomy to record any changes."}],"outcomes":[{"outcome_type":"primary","measure":"Change in semen parameters","time_frame":"February 2017 (anticipated duration of the study)"},{"outcome_type":"secondary","measure":"Change in hormone levels","time_frame":"February 2017 (anticipated end of the study)"}]}
{"nct_id":"NCT01325792","start_date":"2011-02-28","enrollment":104,"brief_title":"Open Complex Ventral Incisional Hernia Repair Using Biosynthetic Material for Midline Fascial Closure Reinforcement","official_title":"Prospective, Multicenter, Observational Study Evaluate Single-Staged Open Complex Ventral Incisional Hernia Repair Using a Biosynthetic Material for Midline Fascial Closure Reinforcement","primary_completion_date":"2014-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2014-12-31","last_update":"2015-12-24","description":"Prospective, multicenter, observational study to evaluate performance of GORE BIO-A Tissue Reinforcement when used to reinforce midline fascial closure in single-staged open complex ventral incisional hernia repair.","other_id":"CS155","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"general and teaching hospitals","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subjects will be informed about the study, and will have read; understood and signed\r\n             the informed consent and authorization to use their PHI, as applicable\r\n\r\n          -  Subjects willing and able to submit to postoperative follow-up evaluations including\r\n             quality of life assessments up to 24 months after surgery\r\n\r\n          -  Subjects of either gender that are at least the age of 18 years\r\n\r\n          -  Subjects will have a Body-Mass Index (BMI) of < 40\r\n\r\n          -  Subjects will be undergoing single-staged open complex ventral incisional hernia\r\n             repair with the retrorectus or intraperitoneal placement technique of the GORE BIO-A\r\n             Tissue Reinforcement\r\n\r\n          -  Subjects in which intraoperatively their surgical field/wound is characterized either\r\n             a Type 2 or Type 3 in Table 1 in Section 12.0\r\n\r\n          -  Subjects with a hernia defect > 9 cm2 large when measured intraoperatively\r\n\r\n          -  Subjects in which the required mobility for midline fascial closure without excessive\r\n             tension to reapproximate the rectus abdominis muscle intraoperatively can be achieved\r\n\r\n          -  Subjects in which one unit of GORE BIO-A Tissue Reinforcement will adequately\r\n             reinforce the midline fascial closure with at least 4 cm of overlap laterally\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subjects who, in the surgeon's opinion, would have a difficult time comprehending or\r\n             complying with the requirements of the study\r\n\r\n          -  Subjects with a BMI > 40\r\n\r\n          -  Subjects with evidence of pre-existing systemic infections\r\n\r\n          -  Subjects with cirrhosis or are currently being treated with dialysis\r\n\r\n          -  Subjects with a wound-healing disorder\r\n\r\n          -  Subjects with autoimmune disorder requiring > 10mg of a corticosteroid per day\r\n\r\n          -  Subjects who are immunocompromised such as, with HIV or transplant, or receiving chemo\r\n             or radiation therapy\r\n\r\n          -  Subjects with a hernia defect < 9 cm2 large when measured intraoperatively\r\n\r\n          -  Subjects with a hernia defect requiring more than one unit of GORE BIO-A Tissue\r\n             Reinforcement\r\n\r\n          -  Subjects in which intraoperatively there is an inability to achieve retrorectus or\r\n             intraperitoneal placement of the device\r\n\r\n          -  Subjects in which a midline fascial closure without excessive tension cannot be\r\n             achieved\r\n\r\n          -  Subjects in which intraoperatively their surgical field/wound is characterized either\r\n             a Type 1 or Type 4 in the Table 1 in Section 12\r\n\r\n          -  Subjects in need of concomitant surgical procedures other than indicated in the\r\n             protocol as acceptable\r\n\r\n          -  Subject in which their complex ventral incisional hernia repair requires more than one\r\n             operation to reduce hernia and close fascia, including serial excision procedures -\r\n             requiring subsequent surgery to complete their hernia repair\r\n\r\n          -  Subjects with a hernia repair requiring an emergent procedure, such as strangulated\r\n             bowel\r\n\r\n          -  Subjects in which intraoperatively untreated cancer was found\r\n      ","sponsor":"W.L.Gore & Associates","sponsor_type":"Industry","conditions":"Ventral Incisional Hernia","interventions":[{"intervention_type":"Device","name":"Device: GORE BIO-A Tissue Reinforcement","description":"Retrorectus or intraperitoneal placement of device to reinforce the midline fascial closure after single-staged open complex ventral incisional hernia repair of primary or recurrent anterior abdominal wall hernia."}],"outcomes":[{"outcome_type":"primary","measure":"Hernia Recurrence Rate","time_frame":"at about 24 months","description":"Investigator confirmed hernia recurrence by physical examination"},{"outcome_type":"secondary","measure":"Early and Long-term Complication Rates","time_frame":"after surgery (day 1) to 24 months","description":"Surgical site abdominal wound event rate"}]}
{"nct_id":"NCT01154816","start_date":"2011-02-28","phase":"Phase 2","enrollment":118,"brief_title":"Alisertib in Treating Young Patients With Recurrent or Refractory Solid Tumors or Leukemia","official_title":"A Phase II Study of MLN8237, a Selective Aurora A Kinase Inhibitor in Children With Recurrent/Refractory Solid Tumors and Leukemias","primary_completion_date":"2015-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-06-30","last_update":"2020-05-13","description":"This phase II trial is studying the side effects of and how well alisertib works in treating young patients with relapsed or refractory solid tumors or leukemia. Alisertib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.","other_id":"ADVL0921","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":1,"maximum_age":21,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients must have had histologic verification of malignancy at original diagnosis or\r\n             at relapse, to include any of the following malignancies (no other histology is\r\n             eligible):\r\n\r\n               -  Neuroblastoma- measurable\r\n\r\n               -  Neuroblastoma- MIBG evaluable\r\n\r\n               -  Rhabdomyosarcoma\r\n\r\n               -  Osteosarcoma\r\n\r\n               -  Ewing sarcoma/Peripheral PNET\r\n\r\n               -  Non-RMS soft tissue sarcoma\r\n\r\n               -  Hepatoblastoma\r\n\r\n               -  Malignant germ cell tumor\r\n\r\n               -  Wilms tumor\r\n\r\n               -  Acute lymphoblastic leukemia\r\n\r\n               -  Acute myelogenous leukemia\r\n\r\n               -  Rhabdoid malignancy\r\n\r\n          -  Disease status for solid tumor patients:\r\n\r\n               -  Patients must have radiographically measurable disease (with the exception of\r\n                  neuroblastoma)\r\n\r\n               -  Measurable disease is defined as the presence of at least one lesion on magnetic\r\n                  resonance imaging (MRI) or computed tomography (CT) scan that can be accurately\r\n                  measured with the longest diameter a minimum of 20 mm in at least one dimension;\r\n                  for spiral CT, measurable disease is defined as a minimum diameter of 10 mm in at\r\n                  least one dimension\r\n\r\n               -  Note: The following do not qualify as measurable disease:\r\n\r\n                    -  Malignant fluid collections (e.g., ascites, pleural effusions)\r\n\r\n                    -  Bone marrow infiltration\r\n\r\n                    -  Lesions detected by nuclear medicine studies (e.g., bone, gallium or\r\n                       positron emission tomography [PET] scans)\r\n\r\n                    -  Elevated tumor markers in plasma or cerebrospinal fluid (CSF)\r\n\r\n                    -  Previously irradiated lesions that have not demonstrated clear progression\r\n                       post radiation\r\n\r\n               -  Patients with neuroblastoma who do not have measurable disease but have MIBG+\r\n                  evaluable disease are eligible\r\n\r\n          -  Disease status for leukemia patients:\r\n\r\n               -  Patients with leukemia must be recurrent or refractory to at least two prior\r\n                  induction or treatment regimens, in addition to the following criteria:\r\n\r\n               -  Acute lymphoid leukemia:\r\n\r\n                    -  25% blasts in the bone marrow (M3 bone marrow), excluding patients with\r\n                       known central nervous system (CNS) disease\r\n\r\n               -  Acute myeloid leukemia according to FAB classification\r\n\r\n                    -   5 % blasts in the bone marrow (M2/M3 bone marrow); excluding patients with\r\n                       known CNS disease\r\n\r\n          -  Rhabdoid tumors:\r\n\r\n               -  To be eligible for enrollment in the rhabdoid tumors stratum, the patient must\r\n                  have a solid tumor where the institutional pathological evaluation of the tumor\r\n                  at initial diagnosis or relapse has confirmed:\r\n\r\n                    -  Morphology and immunophenotypic panel consistent with rhabdoid tumor\r\n                       (required)\r\n\r\n                    -  Loss of SWI/SNF related, matrix associated, actin dependent regulator of\r\n                       chromatin, subfamily b, member 1 (INI1) confirmed by immunohistochemistry,\r\n                       or\r\n\r\n                    -  Molecular confirmation of tumor-specific bi-allelic INI1 loss/mutation if\r\n                       INI1 immunohistochemistry is not available; note that molecular confirmation\r\n                       of tumor-specific bi-allelic INI1 loss/mutation is encouraged in cases where\r\n                       INI1 immunohistochemistry is equivocal\r\n\r\n          -  Patients must have a Lansky or Karnofsky performance status score of  50,\r\n             corresponding to Eastern Cooperative Oncology Group (ECOG) categories 0, 1 or 2; use\r\n             Karnofsky for patients > 16 years of age and Lansky for patients  16 years of age;\r\n             Note: Patients who are unable to walk because of paralysis, but who are up in a\r\n             wheelchair, will be considered ambulatory for the purpose of assessing the performance\r\n             score\r\n\r\n          -  Patients must have fully recovered from the acute toxic effects of all prior\r\n             chemotherapy, immunotherapy, or radiotherapy prior to study enrollment\r\n\r\n          -  Myelosuppressive chemotherapy:\r\n\r\n               -  Solid tumors:\r\n\r\n                    -  Patients with solid tumors must not have received myelosuppressive\r\n                       chemotherapy within 3 weeks of enrollment onto this study (6 weeks if prior\r\n                       nitrosourea)\r\n\r\n               -  Leukemia:\r\n\r\n                    -  Patients with leukemia who relapse while receiving standard maintenance\r\n                       therapy will not be required to have a waiting period before enrollment onto\r\n                       this study\r\n\r\n                    -  Patients who relapse while they are not receiving standard maintenance\r\n                       therapy must have completely recovered from all acute toxic effects of\r\n                       chemotherapy, immunotherapy or radiotherapy prior to study enrollment; at\r\n                       least 14 days must have elapsed since the completion of cytotoxic therapy,\r\n                       with the exception of hydroxyurea\r\n\r\n                    -  Note: cytoreduction with hydroxyurea can be initiated and continued for up\r\n                       to 24 hours prior to the start of MLN8237\r\n\r\n          -  At least 7 days must have elapsed since the completion of therapy with a growth\r\n             factor; at least 14 days must have elapsed after receiving pegfilgrastim\r\n\r\n          -  At least 7 days must have elapsed since completion of therapy with a biologic agent;\r\n             for agents that have known adverse events occurring beyond 7 days after\r\n             administration, this period prior to enrollment must be extended beyond the time\r\n             during which adverse events are known to occur\r\n\r\n          -  At least 3 half-lives must have elapsed since prior therapy that included a monoclonal\r\n             antibody\r\n\r\n          -   2 weeks must have elapsed since local palliative radiation therapy (XRT) (small\r\n             port);  6 weeks must have elapsed since treatment with therapeutic doses of MIBG;  6\r\n             months must have elapsed if prior craniospinal XRT was received, if  50% of the\r\n             pelvis was irradiated, or if total body irradiation (TBI) was received;  6 weeks must\r\n             have elapsed if other substantial bone marrow irradiation was given\r\n\r\n          -  No evidence of active graft vs. host disease and  3 months must have elapsed since\r\n             transplant\r\n\r\n          -  For patients with solid tumors without bone marrow involvement:\r\n\r\n               -  Peripheral absolute neutrophil count (ANC) >= 1000/mm^3\r\n\r\n               -  Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving\r\n                  platelet transfusions within a 7 day period prior to enrollment)\r\n\r\n               -  Hemoglobin > 8.0 g/dL (may receive red blood cell [RBC] transfusions)\r\n\r\n          -  For patients with solid tumors and known bone marrow metastatic disease:\r\n\r\n               -  Peripheral absolute neutrophil count (ANC)  750/mm^3\r\n\r\n               -  Platelet count  50,000/mm^3\r\n\r\n               -  Hemoglobin  8.0 g/dL\r\n\r\n               -  Transfusions are permitted to meet both the platelet and hemoglobin criteria;\r\n                  patients must not be known to be refractory to red blood cell or platelet\r\n                  transfusions\r\n\r\n          -  Patients with leukemia must not be known to be refractory to red blood cell or\r\n             platelet transfusions\r\n\r\n          -  Creatinine clearance or radioisotope glomerular filtration rate (GFR) 70 mL/min/1.73\r\n             m^2 or a serum creatinine based on age/gender as follows:\r\n\r\n               -  1 to < 2 years: 0.6\r\n\r\n               -  2 to < 6 years: 0.8\r\n\r\n               -  6 to < 10 years: 1\r\n\r\n               -  10 to < 13 years: 1.2\r\n\r\n               -  13 to < 16 years: 1.5 (male), 1.4 (female)\r\n\r\n               -  >= 16 years: 1.7 (male), 1.4 (female)\r\n\r\n          -  Total bilirubin =< 1.5 x upper limit of normal (ULN) for age\r\n\r\n          -  Serum glutamic pyruvate transaminase (SGPT) (alanine aminotransferase [ALT])  5.0 x\r\n             ULN for age ( 225 U/L); for the purpose of this study, the ULN for SGPT is 45 U/L\r\n\r\n          -  Serum albumin  2 g/dL\r\n\r\n          -  All patients and/or their parents or legal guardians must sign a written informed\r\n             consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who are pregnant or breast-feeding are not eligible for this study; negative\r\n             pregnancy tests must be obtained in girls who are post-menarchal; males or females of\r\n             reproductive potential may not participate unless they have agreed to use an effective\r\n             contraceptive method for the duration of study therapy; breastfeeding women are\r\n             excluded\r\n\r\n          -  Growth factors that support platelet or white cell number or function must not have\r\n             been administered within the 7 days prior to enrollment (14 days if pegfilgrastim)\r\n\r\n          -  Patients requiring corticosteroids who have not been on a stable or decreasing dose of\r\n             corticosteroid for the 7 days prior to enrollment are not eligible\r\n\r\n          -  Patients who are currently receiving another investigational drug are not eligible\r\n\r\n          -  Patients who are currently receiving other anti-cancer agents are not eligible\r\n\r\n          -  Use of daily benzodiazepine therapy excludes a patient from being eligible because of\r\n             the potential benzodiazepine-like effects of MLN8237\r\n\r\n          -  Patients who are currently receiving digoxin, cyclosporine, tacrolimus, or sirolimus\r\n             are not eligible\r\n\r\n          -  Patients who are unable to swallow tablets are not eligible\r\n\r\n          -  Patients who have an uncontrolled infection are not eligible\r\n\r\n          -  Leukemia patients with CNS disease are not eligible\r\n\r\n          -  Patients who in the opinion of the investigator may not be able to comply with the\r\n             safety monitoring requirements of the study are not eligible\r\n      ","sponsor":"Children's Oncology Group","sponsor_type":"Other","conditions":"Hepatoblastoma|Previously Treated Childhood Rhabdomyosarcoma|Recurrent Childhood Acute Lymphoblastic Leukemia|Recurrent Childhood Acute Myeloid Leukemia|Recurrent Childhood Kidney Neoplasm|Recurrent Childhood Malignant Germ Cell Tumor|Recurrent Childhood Rhabdomyosarcoma|Recurrent Childhood Soft Tissue Sarcoma|Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor|Recurrent Neuroblastoma|Recurrent Osteosarcoma","interventions":[{"intervention_type":"Drug","name":"Drug: Alisertib","description":"Given orally"},{"intervention_type":"Other","name":"Other: Laboratory Biomarker Analysis","description":"Correlative studies"},{"intervention_type":"Other","name":"Other: Pharmacological Study","description":"Correlative studies"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants With Overall Response","time_frame":"From first dose of alisertib through 6 cycles of protocol therapy or until removal from protocol therapy whichever occurred first.","description":"For patients with recurrent solid tumors a patient who experienced a complete or partial response according to RECIST version 1.1 criteria is considered a responder. For patients with recurrent acute lymphoblastic leukemia a patient who experiences a bone marrow evaluation with < 5% blast cells on morphological evaluation of bone marrow will be considered a responder. For patients with recurrent acute myelogenous leukemia a patient who experiences a complete remission or complete remission with partial recovery of platelet count according to the AML International Working Group Criteria will be considered a responder."},{"outcome_type":"secondary","measure":"Number of Patients Cycles With Grade 3 or Higher Adverse Event","time_frame":"Up to 24 months","description":"The number of patient-cycles in which the adverse event considered grade 3 or higher AE according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 considered by the treating physician to be possibly, probably or definitely related to alisertib."},{"outcome_type":"secondary","measure":"Serum Concentration of Alisertib Prior to the First Day of Administration","time_frame":"day 1 of protocol therapy","description":"Serum concentration of alisertib prior to the first day of administration in nanograms/milliliter."},{"outcome_type":"secondary","measure":"Serum Concentration of Alisertib on the First Day of Administration One Hour After Administration","time_frame":"day 1 of protocol therapy","description":"Serum concentration of alisertib on the first day of administration one hour after administration in nanograms/milliliter."},{"outcome_type":"secondary","measure":"Serum Concentration of Alisertib on the First Day of Administration Three Hours After Administration","time_frame":"day 1 of protocol therapy","description":"Serum concentration of alisertib on the first day of administration three hours after administration in nanograms/milliliter."},{"outcome_type":"secondary","measure":"Serum Concentration of Alisertib on the First Day of Administration Six Hours After Administration","time_frame":"day 1 of protocol therapy","description":"Serum concentration of alisertib on the first day of administration six hours after administration in nanograms/milliliter."},{"outcome_type":"secondary","measure":"Serum Concentration of Alisertib on the Fourth Day of Administration Prior to the Administration of the Day 4 Dose","time_frame":"day 4 of protocol therapy","description":"Serum concentration of alisertib on the fourth day of administration prior to the administration of the day 4 dose in nanograms/milliliter."},{"outcome_type":"secondary","measure":"Serum Concentration of Alisertib on the Seventh Day of Administration Prior to the Administration of the Day 7 Dose.","time_frame":"day 7 of protocol therapy","description":"Serum concentration of alisertib on the seventh day of administration prior to the administration of the day 7 dose in nanograms/milliliter."}]}
{"nct_id":"NCT01162018","start_date":"2011-02-28","phase":"N/A","enrollment":65,"brief_title":"Acupuncture for Sleep Disruption in Cancer Survivors","official_title":"Acupuncture for Sleep Disruption in Cancer Survivors","primary_completion_date":"2012-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-08-31","last_update":"2019-04-04","description":"The proposed study will recruit 60 women with breast cancer who finished undergoing treatment who complain of persistent insomnia problems that began with onset of their cancer diagnosis. The eligible women would be randomized and stratified by sleep problems to two arms: (Acupuncture Arm vs. Sham Acupuncture) with a goal of having 48 patients complete the study (we anticipate about 20% attrition rate). The study interventions will begin after patients completed their treatment. The placebo control for acupuncture will be a validated sham acupuncture control Assessments will be made with daily diaries and with weekly questionnaires. PSG data will be collected on the subsample of the population. Data will be gathered via pencil-and-paper measures before, during, immediately following, one month following the completion of treatment and six months after the conclusion of treatment. In addition, actigraphy data (objective sleep continuity data) will be acquired prior to and following treatment","other_id":"BRSADJ0020","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Females diagnosed with breast cancer who are not currently undergoing cancer treatment\r\n             (hormonal treatment is permitted).\r\n\r\n          -  The last cancer treatment  2 weeks prior to screening.\r\n\r\n          -   21 years of age.\r\n\r\n          -  Able to understand written and spoken English.\r\n\r\n          -  Have a habitual bedtime between 9:00 pm and 3:00 am and a habitual rise time between\r\n             4:00 am and 11 am.\r\n\r\n          -  Meet DSM-IV criteria for insomnia (determined by the of the Duke Structured Interview\r\n             of Sleep Disorders) with duration  1 month by Screening.\r\n\r\n          -  Willingness to discontinue the use of any current sleep aides (prescription, OTC, or\r\n             naturopathic agents).\r\n\r\n          -  Properly executed Informed Consent.\r\n\r\n          -  Karnofsky Performance Scale Index score  to 70, (patients who score between 61-69\r\n             might be included per PI's evaluation).\r\n\r\n          -  Insomnia Severity Index (ISI) > 8 at Screening.\r\n\r\n          -  Able to travel to Stanford University and vicinity for assessments and acupuncture\r\n             treatments.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Unstable medical or psychiatric illness (eMINI, current or within the last 5 years).\r\n\r\n          -  Exposure to acupuncture within 6 months prior to screening.\r\n\r\n          -  Currently pregnant or nursing.\r\n\r\n          -  History of substance abuse or meet criteria for current alcohol abuse or dependence.\r\n\r\n          -  Center for Epidemiological Studies Depression Scale (CES-D) >27 at Screening. Meet\r\n             criteria for sleep apnea, restless legs syndrome or Circadian Rhythm Sleep Disorder on\r\n             the basis of the Duke Structured Interview of Sleep Disorders (DSISD) or STOP-BANG is\r\n              to 3.\r\n\r\n          -  Major surgery within 4 weeks prior to first acupuncture treatment.\r\n      ","sponsor":"Stanford University","sponsor_type":"Other","conditions":"Sleep Initiation and Maintenance Disorders|Breast Cancer","interventions":[{"intervention_type":"Procedure","name":"Procedure: acupuncture","description":"The eligible women would be randomized and stratified by sleep problems to two arms: (Acupuncture Arm vs. Sham Acupuncture) with a goal of having 48 patients complete the study (we anticipate about 20% attrition rate). The study interventions will begin after patients completed their treatment. The placebo control for acupuncture will be a validated sham acupuncture control Assessments will be made with daily diaries and with weekly questionnaires. There are ten sessions each lasting approximately 20 minutes. All participants will have PSG data collected."},{"intervention_type":"Other","name":"Other: placebo"}],"outcomes":[{"outcome_type":"primary","measure":"Fatigue reduction","time_frame":"1 month and 3 months post final acupuncture treatment"},{"outcome_type":"primary","measure":"Quality of life in breast cancer survivors after acupuncture","time_frame":"1 month and 6 months post final acupuncture treatment","description":"Quality of life in breast cancer survivors after acupuncture will be measured through questionnaire using 28 item scale of functional assessment of chronic illness therapy- fatigue subscale (FACIT-F) version 4. Total score ranges from 0 to 108. A higher score indicates better quality of life."},{"outcome_type":"primary","measure":"Insomnia reduction","time_frame":"1 month and 3 months post final acupuncture treatment"}]}
{"nct_id":"NCT01321593","start_date":"2011-02-28","enrollment":300,"brief_title":"Hemoglobin Measured by \"Orsense NBM-200MP\" Device and Laboratory Measurement","official_title":"Comparison of the Hemoglobin Results Obtained With the \"Orsense NBM-200MP\" Device and the Clinical Laboratory","primary_completion_date":"2011-03-31","study_type":"Observational","rec_status":"Completed","completion_date":"2011-03-31","last_update":"2016-11-03","description":"The purpose of this study is to compare the hemoglobin results obtained with the \"Orsense NBM-200MP\" device and the Clinical Laboratory.","other_id":"2010/28","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"emergency unit patients requiring an hemoglobin determination","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  emergency unit patients requiring an hemoglobin determination\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  none\r\n      ","sponsor":"Hopital Foch","sponsor_type":"Other","conditions":"Emergency","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Hemoglobin measurement using the \"Orsense NBM-200MP\" device","time_frame":"4 months"}]}
{"nct_id":"NCT01388972","start_date":"2011-02-28","enrollment":2924,"brief_title":"Assessment of Food Environment and Physical Activity Opportunities in Three Neighbourhoods of Buenos Aires City","official_title":"Assessment of Food Environment and Physical Activity Opportunities in Three Neighbourhoods of Buenos Aires City","primary_completion_date":"2011-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2012-01-31","last_update":"2019-08-13","description":"Several environmental factors have contributed to the growing pandemic of obesity. It has been described that some characteristics of food and built environment have an influence on patterns of food consumption and physical activity of people in a certain place. We have designed a cross-sectional study to describe some aspects of the food environment (community and consumer) and the frequency, distribution and characteristics of the space available to perform physical activity in three neighborhoods of Buenos Aires city. Three neighborhoods of Buenos Aires (with representativity), from different socioeconomic strata, will be selected by convenience to conduct this study. The study will consist on three stages: first, the generation of the sampling frame of food stores, public and private spaces available for carrying out physical activity, and the development of a tool designed to evaluate the availability of healthy foods in supermarkets and grocery stores. Finally, a sample of those stores will be randomly selected for assessing the availability of selected foods. In Argentina, the knowledge of the food environment is limited. We believe that the information obtained in this study will contribute to a better understanding of the subject.","other_id":"1656","observational_model":"Ecologic or Community","time_perspective":"Cross-Sectional","sampling_method":"Probability Sample","gender":"All","population":"A community sample of Recoleta, Almagro and Constitucion neighborhoods of Buenos Aires,\r\n        Argentina has been conveniently selected by major representation of different socioeconomic\r\n        stratus. The value of the square meter of the property (2 rooms apartments) was used as\r\n        indirect indicator of socioeconomic level.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Stable Places and ambulant stands (only those that are located habitually in the same\r\n             place) of food sale and / or drinks of any type.\r\n\r\n          -  Public or private spaces destined for the accomplishment of physical activity.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Places and stands of food sale and / or drinks and spaces for the accomplishment of\r\n             physical activity not opened the public in general (as those who are inside schools,\r\n             places of work, centers of health, etc.)\r\n      ","sponsor":"Hospital Italiano de Buenos Aires","sponsor_type":"Other","conditions":"Nutrition|Physical Activity","interventions":{},"outcomes":{}}
{"nct_id":"NCT01460615","start_date":"2011-02-28","phase":"Phase 2","brief_title":"Cortisone Treatment for the Prevention of Postoperative Pancreatitis and Pancreatitis-induced Complications After Pancreaticoduodenectomy and Distal Pancreatic Resection","primary_completion_date":"2017-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-01-31","last_update":"2018-11-29","description":"The purpose of this randomized, placebo-controlled trial is to investigate whether postoperative pancreatitis and other immediate complications after pancreaticoduodenectomy or distal pancreatic resection may be reduced with cortisone treatment. Treatment is administered to high risk patients (defined by high amount of acinar cells in the cut edge of pancreas).","other_id":"R11009M","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Pancreaticoduodenectomy and distal pancreatectomy patients in Tampere University\r\n             Hospital\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with an ongoing cortisone treatment\r\n\r\n          -  Cefuroxime allergy\r\n\r\n          -  Chronic pancreatitis\r\n      ","sponsor":"Tampere University Hospital","sponsor_type":"Other","conditions":"Postoperative Complications|Postoperative Pancreatitis","interventions":[{"intervention_type":"Drug","name":"Drug: Hydrocortisone"}],"outcomes":[{"outcome_type":"primary","measure":"Postoperative overall complications of pancreatic resection","time_frame":"within the first 30 days after surgery","description":"e.g. Postoperative pancreatic fistula, delayed gastric emptying, postpancreatectomy hemorrhage, biliary fistula, wound infection, postoperative pancreatitis."}]}
{"nct_id":"NCT01202253","start_date":"2011-02-28","enrollment":50,"brief_title":"Early Clinical Experience With Anidulafungin In Patients With Liver Disease In The United Kingdom","official_title":"A Study To Describe The Early Clinical Experience With Anidulafungin In Patients With Liver Disease At King's College Hospital NHS Trust, London","primary_completion_date":"2011-05-31","study_type":"Observational","rec_status":"Completed","completion_date":"2011-05-31","last_update":"2014-04-16","description":"The purpose of this study is to describe the real world effectiveness of anidulafungin in clinical practice in a large Liver Unit in the United Kingdom.","other_id":"A8851028","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":90,"population":"Subjects admitted with candidiasis infections to the Liver Unit at King's College Hospital\r\n        (United Kingdom) who are prescribed anidulafungin.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subjects who have been prescribed anidulafungin between 1st July 2009 and 30th\r\n             September 2010.\r\n\r\n        Patients admitted to specialist liver unit wards and the Liver Intensive Therapy Unit\r\n        during this period\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who participated in any interventional clinical trial during this episode of\r\n             sepsis.\r\n\r\n        Patients who received anidulafungin for infection prophylaxis\r\n      ","sponsor":"Pfizer","sponsor_type":"Industry","conditions":"Candidiasis","interventions":[{"intervention_type":"Drug","name":"Drug: anidulafungin","description":"A single 200 mg loading dose should be administered on Day 1, followed by 100 mg daily thereafter."}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of Participants With Favorable Outcome","time_frame":"Day 28 post-treatment","description":"Favorable outcome was defined as favorable clinical response and documented or presumed microbial eradication (two negative follow-up blood cultures for bloodstream infections or a successful clinical response without follow-up cultures for other infections). Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy."},{"outcome_type":"secondary","measure":"Percentage of Participants With Unfavorable Outcome","time_frame":"Day 28 post-treatment","description":"Unfavorable outcome was defined as the need to change to another antifungal agent because of lack of clinical response or death due to the antifungal infection or microbiologic persistence of the fungus or superinfection with a new Candida, Aspergillus or other fungal strain occurring at least 3 days and up to 14 days of anidulafungin therapy, or a lack of follow up data about clinical and microbiologic responses at the end of anidulafungin therapy."},{"outcome_type":"secondary","measure":"Percentage of Participants Who Died Due to All Causes","time_frame":"Baseline up to Day 28 post-treatment","description":"Death due to all causes included death attributable to fungal infection, death unrelated to fungal infection and death due to multiple causes."},{"outcome_type":"secondary","measure":"Percentage of Participants With Death Attributable to Fungal Infection","time_frame":"Baseline up to Day 28 post-treatment"},{"outcome_type":"secondary","measure":"Percentage of Participants With Death Unrelated to Fungal Infection","time_frame":"Baseline up to Day 28 post-treatment"},{"outcome_type":"secondary","measure":"Percentage of Participants With Favorable Clinical Response","time_frame":"Day 28 post-treatment","description":"Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy."},{"outcome_type":"secondary","measure":"Percentage of Participants With Lack of Clinical Response","time_frame":"Day 28 post-treatment","description":"Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy."},{"outcome_type":"secondary","measure":"Percentage of Participants Requiring Change or Additional Antifungal Therapy","time_frame":"Baseline up to Day 28 post-treatment","description":"Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100)."},{"outcome_type":"secondary","measure":"Percentage of Participants With Oral Antifungal Started to Complete Therapy","time_frame":"Baseline up to Day 28 post-treatment"},{"outcome_type":"secondary","measure":"Percentage of Participants With Documented Eradication of Infecting Species","time_frame":"Baseline","description":"Documented microbial eradication was defined as 2 negative follow-up blood cultures for bloodstream infections."},{"outcome_type":"secondary","measure":"Percentage of Participants With Resolution of Signs of Infection According to Ultrasound Scan Results","time_frame":"Baseline up to Day 28 post-treatment","description":"An ultrasound scan was performed and the resultant scan was reviewed for the presence of the infection as per investigator's discretion."},{"outcome_type":"secondary","measure":"Percentage of Participants With Resolution of Signs of Infection According to Computerized Tomography (CT) Scan Results","time_frame":"Baseline up to Day 28 post-treatment","description":"A CT scan was performed and the resultant scan was reviewed for the presence of the infection as per investigator's discretion."},{"outcome_type":"secondary","measure":"Percentage of Participants With Abnormal Results for Liver Function at Initiation of Drug Therapy","time_frame":"Baseline","description":"Percentage of participants with abnormal liver function results were based on 4 liver function variables- bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase. Normal reference ranges of these variables are: plasma bilirubin: 3-17 micromoles/L or 2.5-10 mg/L for adults; aspartate transaminase: 6-34 International Units/Liter (IU/L) for females and 8-40 IU/L for males; alkaline phosphatase: 5-38 IU/L for females and 10-50 IU/L for males; gamma glutamyl transferase: 7-32 IU/L for females and 11-50 IU/L for males. Upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100 by standard calculations (outside the valid range of 0 to 100)."},{"outcome_type":"secondary","measure":"Percentage of Participants With Abnormal Results for Liver Function at End of Drug Therapy","time_frame":"Day 28 post-treatment","description":"Percentage of participants with abnormal liver function results were based on 4 liver function variables- bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase. Normal reference ranges of these variables are: plasma bilirubin: 3-17 micromoles/L or 2.5-10 mg/L for adults; aspartate transaminase: 6-34 IU/L for females and 8-40 IU/L for males; alkaline phosphatase: 5-38 IU/L for females and 10-50 IU/L for males; gamma glutamyl transferase: 7-32 IU/L for females and 11-50 IU/L for males."},{"outcome_type":"secondary","measure":"Percentage of Participants With Liver Function Test Results at Least Twice the Baseline Value During Period of Drug Therapy","time_frame":"Baseline up to Day 28 post-treatment","description":"Percentage of participants with liver function test results at least twice the baseline value during period of drug therapy was calculated for the liver function variables, bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase."},{"outcome_type":"secondary","measure":"Percentage of Participants With Creatinine Clearance at Least Twice the Baseline Value During Period of Drug Therapy","time_frame":"Baseline up to Day 28 post-treatment"},{"outcome_type":"secondary","measure":"Percentage of Participants Admitted to Liver Intensive Therapy Unit (LITU)","time_frame":"Baseline"},{"outcome_type":"secondary","measure":"Duration of Stay at Liver Intensive Therapy Unit (LITU)","time_frame":"Baseline up to Day 28 post-treatment"},{"outcome_type":"secondary","measure":"Percentage of Participants With Absolute Neutrophil Count Less Than 500 Per Cubic Millimeter (/mm^3) and Greater Than or Equal to 500 /mm^3","time_frame":"Baseline","description":"Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 and upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100, by standard calculations (outside the valid range of 0 to 100)."},{"outcome_type":"secondary","measure":"Percentage of Participants With Concomitant Bacterial or Viral Infection","time_frame":"Baseline","description":"Upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100 by standard calculations (outside the valid range of 0 to 100)."},{"outcome_type":"secondary","measure":"Percentage of Participants Prescribed With Systemic Antifungal Within 30 Days Before Study Start","time_frame":"Baseline","description":"Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100)."},{"outcome_type":"secondary","measure":"Dose Changes for Immunosuppressant Drugs","time_frame":"Baseline up to Day 28 post-treatment"},{"outcome_type":"secondary","measure":"Percentage of Participants With Probable or Proven Fungal Infection at the Initiation of Drug Therapy","time_frame":"Baseline"},{"outcome_type":"secondary","measure":"Percentage of Participants With Documented Body Temperature Above 38.0 Degree Celsius or Below 36.0 Degree Celsius Within 24 Hour Period Prior to Initiation of Drug Therapy","time_frame":"Baseline","description":"Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 and upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100, by standard calculations (outside the valid range of 0 to 100)."},{"outcome_type":"secondary","measure":"Percentage of Participants With Systolic Blood Pressure More Than 2 Standard Deviations Below the Mean for Age Recorded Within 24 Hour Period Prior to Initiation of Drug Therapy","time_frame":"Baseline","description":"Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100)."},{"outcome_type":"secondary","measure":"Number of Participants With Infection Sites as Per Microbiological Analysis","time_frame":"Baseline","description":"Infection sites included blood, chest, urinary tract, intra-abdominal, bile duct, liver, kidney, mouth and esophagus."},{"outcome_type":"secondary","measure":"Number of Participants With Infection Sites as Per Ultrasound Scan and Computerized Tomography (CT) Scan","time_frame":"Baseline"},{"outcome_type":"secondary","measure":"Infecting Organisms by Species","time_frame":"Baseline up to Day 14 post-treatment"},{"outcome_type":"secondary","measure":"Percentage of Participants With Prior Colonization With Candida by Species","time_frame":"Baseline","description":"Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100)."},{"outcome_type":"secondary","measure":"Percentage of Participants With Prior Colonization With Candida by Colonization Index","time_frame":"Baseline"},{"outcome_type":"secondary","measure":"Percentage of Participants With Other Prior Fungal Infection by Species and Colonization Index","time_frame":"Baseline"},{"outcome_type":"secondary","measure":"Number of Participants Who Received Water-based and Ethanol-based Formulation","time_frame":"Baseline"},{"outcome_type":"secondary","measure":"Percentage of Participants Who Received Water-based and Ethanol-based Formulation","time_frame":"Baseline"},{"outcome_type":"secondary","measure":"Percentage of Participants Who Received 200 mg Loading Dose","time_frame":"Day 1"},{"outcome_type":"secondary","measure":"Percentage of Participants Who Received 100 mg Dose on Day 2","time_frame":"Day 2"},{"outcome_type":"secondary","measure":"Percentage of Participants Who Received 200 mg Dose on Day 1 and 100 mg for All Subsequent Doses","time_frame":"Baseline up to Day 28 post-treatment"},{"outcome_type":"secondary","measure":"Number of Participants With Other Dosing Patterns","time_frame":"Baseline up to Day 28 post-treatment","description":"The other dosing patterns for anidulafungin included any dosing pattern different from 200 mg loading dose on Day 1 followed by 100 mg doses subsequently starting from Day 2."},{"outcome_type":"secondary","measure":"Duration of Anidulafungin Therapy","time_frame":"Baseline"},{"outcome_type":"secondary","measure":"Number of Serious Adverse Events (SAEs)","time_frame":"Baseline up to Day 28 post-treatment","description":"Any untoward medical occurrence in a participant who received study treatment was considered an adverse event (AE) without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly."},{"outcome_type":"secondary","measure":"Percentage of Participants With One or More Drug-related Serious Adverse Events (SAEs)","time_frame":"Baseline up to Day 28 post-treatment"},{"outcome_type":"secondary","measure":"Number of Participants With Different Types of Drug-related Serious Adverse Events","time_frame":"Baseline up to Day 28 post-treatment"}]}
{"nct_id":"NCT01235247","start_date":"2011-02-28","phase":"N/A","brief_title":"Decision Support AMPATH","official_title":"Electronic Medical Records to Improve Patient & Public Health in Rural Kenya","primary_completion_date":"2011-10-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2012-03-31","last_update":"2011-07-29","description":"Computer-generated clinical reminders offered to providers will improve compliance with care guidelines and impact outcomes in resource-limited clinics.","other_id":"0709-63","primary_purpose":"Health Services Research","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  All pregnant women, children born to HIV+ mothers, and TB/HIV co-infected patients\r\n             visiting these clinics during the this study will be included.\r\n\r\n        Exclusion Criteria:\r\n\r\n        -\r\n      ","sponsor":"Indiana University","sponsor_type":"Other","conditions":"Behavior","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: reminders vs. no reminders","description":"Intervention providers will receive clinical reminders as part of patient care, and control group providers will not receive the reminders"}],"outcomes":[{"outcome_type":"primary","measure":"Compliance rates with care guidelines","time_frame":"12 months"}]}
{"nct_id":"NCT01284374","start_date":"2011-02-28","enrollment":62,"brief_title":"Parent-son-provider Decision-making About HPV Vaccination","official_title":"An Investigation of Parent-son-provider Decision-making About HPV Vaccination","primary_completion_date":"2012-11-30","study_type":"Observational","rec_status":"Completed","completion_date":"2012-11-30","last_update":"2012-12-17","description":"The objectives of this study are: 1. To better understand factors associated with acceptance and refusal of HPV vaccine among parent-son pairs and the process of parent-son decision-making with respect to vaccination. 2. To evaluate health care providers (HCPs) attitudes, implementation intentions, and planned communication strategies with respect to HPV vaccination of adolescent boys. Hypothesis 1: Sons will have a significant role in the process of parent-son decision-making about HPV vaccination. The relative importance of this role will increase with the son's age. Hypothesis 2: Pediatric HCPs will be unsure about vaccinating males and will lack knowledge about issues related to male HPV infection and vaccination.","other_id":"Merck IISP 38094","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":13,"maximum_age":17,"population":"Parent-Adolescent pairs attending community-based adolescent health primary care clinics","criteria":"\n        Inclusion Criteria:\r\n\r\n        Adolescent:\r\n\r\n          -  English-speaking adolescent boys\r\n\r\n          -  13-17 years of age\r\n\r\n          -  No prior receipt of HPV vaccine\r\n\r\n          -  Accompanied by parent\r\n\r\n        Parent:\r\n\r\n          -  English-speaking or Spanish-speaking parent\r\n\r\n        Health Care Provider:\r\n\r\n          -  Physician\r\n\r\n          -  Provides care to adolescent boys 13-17 years of age\r\n\r\n        Exclusion Criteria:\r\n\r\n        Adolescent:\r\n\r\n          -  Non-English-speaking\r\n\r\n          -  Younger than 13 or older than 17\r\n\r\n          -  Previous receipt of 1 or more doses of HPV vaccine\r\n\r\n        Parent:\r\n\r\n          -  Non-English-speaking and Non-Spanish-speaking\r\n\r\n        Health Care Provider:\r\n\r\n          -  Not a physician\r\n\r\n          -  Does not provide care to males 13-17 years of age\r\n      ","sponsor":"Indiana University","sponsor_type":"Other","conditions":"Human Papillomavirus Vaccination","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Decision Regarding Acceptance/Refusal of 1st Dose of HPV Vaccine","time_frame":"Up to 1 hour","description":"The semi-structured interviews with parents & sons will focus on how the decision was made to accept or refuse HPV vaccine. The interviews will take place immediately after the clinic visit during which the vaccination decision was made."},{"outcome_type":"primary","measure":"Health care providers decision-making regarding HPV vaccination of males","time_frame":"Up to 1 hour","description":"Semi-structured interviews will be conducted with 20 health care providers regarding their decision-making around vaccinating adolescent male patients against HPV"}]}
{"nct_id":"NCT02454998","start_date":"2011-02-28","phase":"N/A","enrollment":24,"brief_title":"Alveolar Bone Grafting Outcome Between Patient With and Without Orthodontic Treatment","official_title":"The Difference in the Surgical Outcome of Unilateral Cleft Lip and Palate Between Patients With and Without Pre-Alveolar Bone Graft Orthodontic Treatment","primary_completion_date":"2015-07-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2015-08-31","last_update":"2015-05-27","description":"Alveolar bone grafting (ABG) is an essential part of the surgical management of cleft lip and palate patients. This procedure could obliterate oronasal fistula, stabilize dental arch, offer bone matrix for adjacent teeth eruption. Moreover, by obliterating oronasal fistula, we stop the chronic irritation of nasal mucosa by oral content. Hence, the symptoms of rhinorrhea or nasal obstruction could be improved. This dental arch defect could predispose further dental arch medial collapse. Without alveolar bone grafting the dental arch is not stable, dental movement during orthodontic treatment is limited and dental arch expansion is not possible. Previous to operation, the patient suffered from dental crowding and dental inclination toward to the cleft. This produces a difficult dental hygiene and predispose to dental caries and gingivitis. Pre-operative orthodontics treatment is advised in many centers. By aligned the teeth previous to surgery, with a better dental hygiene, we purpose that the infection rate will be reduced and success rate will be better. The Purpose of this study is to determine whether pre-operative orthopedic treatment will affect secondary alveolar bone grafting outcome and to assess the nasal change after alveolar bone graft.","other_id":"102-3500C (99-3910A3)","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":8,"maximum_age":12,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Unilateral complete cleft lip patients\r\n\r\n          2. Alveolar bone cleft diagnosed with conventional radiographic study\r\n\r\n          3. Patients at the stage of mixed dentition.\r\n\r\n          4. Informed consent signed by the parents or custodians.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Presentation of other craniofacial anomalies.\r\n\r\n          2. Parents or custodians who do not agreed to this procedure.\r\n      ","sponsor":"Chang Gung Memorial Hospital","sponsor_type":"Other","conditions":"Cleft Lip","interventions":[{"intervention_type":"Other","name":"Other: orthodontic treatment","description":"Braces on the upper dental arch previous to surgical alveolar bone grafting. the goal is optimizing the structure of dental-alveolar structure."}],"outcomes":[{"outcome_type":"primary","measure":"Pre-orthodontic alveolar bone defect","time_frame":"Before surgical and orthodontic treatment, A expected average of 6 months before surgery","description":"CT scan, measurement of alveolar bone cleft defect volume"},{"outcome_type":"primary","measure":"Pre-surgical alveolar bone defect","time_frame":"Before surgical treatment (alveolar bone cleft), a expected average of 6 months of orthodontic treatment","description":"CT scan, measurement of alveolar bone cleft defect volume"},{"outcome_type":"primary","measure":"Alveolar bone graft survival","time_frame":"A expected average of 6 months after surgery","description":"CT scan, measurement of volume of bone graft filling the alveolar bone cleft"},{"outcome_type":"secondary","measure":"Infection rate","time_frame":"up to 6 months","description":"Evaluate the infection rate after surgery"}]}
{"nct_id":"NCT01290432","start_date":"2011-02-28","phase":"N/A","enrollment":15,"brief_title":"The Potential Effects of Inofolic Plus on Abnormal Ovarian Reserve Parameters in Subfertile Women","official_title":"The Potential Effects of Inofolic Plus on Abnormal Ovarian Reserve Parameters in Subfertile Women","primary_completion_date":"2012-02-29","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-02-29","last_update":"2012-05-25","description":"Dr. Roseff and his colleagues are conducting a study to evaluate the effectiveness of a novel substance (Inofolic Plus) in improving oocyte (egg) parameters in subfertile female patients, as measured through Anti-Mullerian Hormone (AMH) blood levels.","other_id":"Roseff-01","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":42,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Female between 18 - 42 years of age\r\n\r\n          -  Diagnosed with \"Diminished Ovarian Reserve\" (DOR)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Ongoing history of illicit drug or tobacco use\r\n\r\n          -  Ovarian surgery within 90 days of signing the consent form\r\n      ","sponsor":"Palm Beach Center for Reproductive Medicine","sponsor_type":"Other","conditions":"Infertility, Female","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Inofolic Plus","description":"Inofolic Plus contains folic acid and myoinositol and melatonin"}],"outcomes":[{"outcome_type":"primary","measure":"Potential Effects of Inofolic Plus on Abnormal Ovarian Reserve (AMH Levels)","time_frame":"Three Months","description":"Women will receive Infolic Plus nightly for up to 90 days. Baseline AMH blood levels will be analyzed, and AMH titers will be checked monthly thereafter for the 90 day duration of the study."}]}
{"nct_id":"NCT01379677","start_date":"2011-02-28","phase":"Phase 3","enrollment":135,"brief_title":"Rubidium-82 PET and Tc-99m-MIBI SPET: A Head to Head Comparison","official_title":"Diagnosis of Coronary Artery Disease With Rubidium-82 PET and Technetium-99m-MIBI SPET: A Head to Head Comparison, Versus Coronary CT Angiography","primary_completion_date":"2013-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-11-30","last_update":"2014-05-14","description":"The main purpose of this study is to compare myocardial perfusion imaging using Rubidium-82 PET with Tc-99m-MIBI SPET, in the evaluation of significant Coronary Artery Disease (CAD).","other_id":"2009Rb82UK","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Referred for scintigraphy to assess myocardial ischaemia\r\n\r\n          -  Ability to give informed written consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Impaired capacity to consent\r\n\r\n          -  Pregnancy, or breastfeeding\r\n\r\n          -  Allergy to iv contrast\r\n\r\n          -  Renal failure\r\n\r\n          -  Severe Uncontrolled asthma\r\n\r\n          -  Claustrophobia\r\n      ","sponsor":"Advanced Accelerator Applications","sponsor_type":"Industry","conditions":"Coronary Artery Disease","interventions":[{"intervention_type":"Drug","name":"Drug: Rubidium-82","description":"Maximum dose allowed per injection: 2200 MBq Maximum cumulated dose allowed per examination: 4400 MBq Intravenous Use"},{"intervention_type":"Drug","name":"Drug: Sestamibi. reconstitution with sodium pertechnetate (99mTc)","description":"Maximum dose allowed per injection: 1000 MBq Intravenous Use"}],"outcomes":[{"outcome_type":"secondary","measure":"Evaluate any adverse events or reactions, during Rubidum-82 or Tc-MIBI administration.","time_frame":"Up to 2 days"},{"outcome_type":"secondary","measure":"Evaluate any difference in image quality, artefacts and interpretative confidence between Rubidium-82 PET and Tc-99m-MIBI SPET.","time_frame":"Up to 2 days"},{"outcome_type":"primary","measure":"The specificity of detecting significant coronary artery disease (as defined as being >70% stenosis, on coronary CT angiography)","time_frame":"Up to 2 days","description":"The primary objective is to compare PET vs. SPET, with the primary outcome being the specificity of detecting significant coronary artery disease (as defined as being >70% stenosis, on coronary CT angiography)."},{"outcome_type":"secondary","measure":"Evaluate any difference in the clinical interpretation of the Rubidium-82 PET and Tc-99m-MIBI SPET images.","time_frame":"Up to 2 days"},{"outcome_type":"secondary","measure":"Evaluate any difference in \"Percentage myocardium\" that is hypoperfused, between Rubidium-82 PET and Tc-99m-MIBI SPET.","time_frame":"Up to 2 days"}]}
{"nct_id":"NCT01292551","start_date":"2011-02-28","phase":"Phase 2","enrollment":75,"brief_title":"Study of Placebo or Bosentan to Treat Patients With Single Ventricle Physiology.","official_title":"Treatment With Endothelin Antagonist to Tcpc Patients; a Multicenter, Randomized, Prospective Study Measuring Maximal O2 Uptake in Ergometer Bicycle Test","primary_completion_date":"2013-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-03-31","last_update":"2013-04-19","description":"The purpose of this study is to determine whether Bosentan is an effective and safe treatment to adolescent and adult (15 years and older) patients, born with one ventricle of the heart instead of two (single ventricle physiology) and who have undergone TCPC as a palliative surgical treatment. The aim of the TCPC operation is to use the one functioning ventricle to pump the blood flow to the body, while the blood to the lungs is received directly from the caval veins, and is thus a passive flow, without the aid of a ventricle to actively pump the blood through the pulmonary circulation. The resistance in the pulmonary circulation is therefore critical to these patients. These patients have markedly lower work capacity in bicycle test than the general public. Furthermore they have a high risk of developing complications e.g. loss of protein from the intestines. Bosentan is a medication that lowers the resistance in the pulmonary circulation. It is routinely used for patients with pulmonary hypertension. Some studies have shown that drugs that lower the pulmonary resistance can increase exercise capacity significantly in patients with single ventricle physiology. In this study 80 patients will receive either placebo or Bosentan for 14 weeks. Before and after the treatment, bicycle test along with blood samples, stool samples and quality of life interviews will be performed. Every four weeks during the study blood samples, physical exam and interviews will be performed to ensure the safety of the treatment. The investigators expect to find a significant increase in work capacity after 14 weeks in the treatment group compared with the placebo group. Moreover the investigators hope to find a decrease in intestinal protein loss and an improved quality of life.","other_id":"TEMPO study","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":15,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  TCPC operated\r\n\r\n          -  Age > 15 years old\r\n\r\n          -  Clinical stability > 3 months, evaluated by investigator from clinical record\r\n\r\n          -  For women: Negative s-hCG and use of contraception\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Severe heart failure (NYHA-class IV)\r\n\r\n          -  Oxygen saturation < 85 % at rest\r\n\r\n          -  Pre-existing liver condition (transaminases 2x > reference)\r\n\r\n          -  Renal failure (creatinin > 150 mmol/l)\r\n\r\n          -  Obstruction of TCPC circulation\r\n\r\n          -  History of work induced severe arrhythmia\r\n\r\n          -  Systolic blood pressure below 80% of reference (BT < 88 mmHg)\r\n\r\n          -  Use of any of following drugs: Fluconazol, Ketoconazole, CiclosporinA, Lopinavir,\r\n             Ritonavir, Rifampicin, Carbamazepin and Phenytoin\r\n\r\n          -  Significant extra-cardiac condition e.g. neurological impairment\r\n      ","sponsor":"Rigshospitalet, Denmark","sponsor_type":"Other","conditions":"Hypoplastic Left Heart Syndrome|Tricuspid Atresia|Other Specified Congenital Anomalies of Heart","interventions":[{"intervention_type":"Drug","name":"Drug: Bosentan","description":"tablets Bosentan 62,5 mg x 2 daily for two weeks, then 125 mg x 2 daily for 12 weeks"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo tablets 2 x daily for 2 weeks, then change to different placebo tablets to match Bosentan group, 2 x daily for 12 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Change from baseline in VO2max at 14 weeks","time_frame":"Baseline and 14 weeks","description":"Maximal O2 uptake in ml/min/kg in ergometer bicycle test"},{"outcome_type":"secondary","measure":"Change from baseline in blood samples at 14 weeks","time_frame":"Baseline and 14 weeks","description":"blood samples measured: plasma CT pro endothelin-1, IgG, IgA, NT pro BNP, albumin, free protein"},{"outcome_type":"secondary","measure":"Change from baseline in SF36 questionnaire score at 14 weeks","time_frame":"Baseline and 14 weeks","description":"SF36 quality of life interview"},{"outcome_type":"secondary","measure":"Change from baseline in feces alfa 1 antitrypsin at 14 weeks","time_frame":"Baseline and 14 weeks","description":"Fecal alfa 1 antitrypsin in mg/g"},{"outcome_type":"secondary","measure":"Number of participants with adverse events","time_frame":"2, 6, 10 and 14 weeks after start of treatment","description":"general interview on adverse effects, and questions with special focus on typical adverse effects in Bosentan"},{"outcome_type":"secondary","measure":"Change from baseline in vital signs","time_frame":"Baseline, 2, 6, 10 and 14 weeks","description":"Systemic bloodpressure in mmHg, Pulse in min-1, Oxygen saturation in percent"},{"outcome_type":"secondary","measure":"Change from baseline in control blood samples","time_frame":"Baseline, 2, 6, 10 and 14 weeks","description":"Liver and renal biomarkers, Hb, PCV, trc and hCG for women"},{"outcome_type":"secondary","measure":"Change from baseline in cardiac output/pulmonary blood flow","time_frame":"Baseline and 14 weeks","description":"CO measured by Stringer Wassermann method during ergometer bicycle test"}]}
{"nct_id":"NCT01327638","start_date":"2011-02-15","enrollment":21108,"brief_title":"Safety of Etoricoxib (MK-0663) in Patients With Spondyloarthropathy (SpA)/Ankylosing Spondylitis (AS) in Sweden (EP07013.013.11.082)","official_title":"Safety Data on Etoricoxib From Swedish Registries of Spondyloarthropathy/Ankylosing Spondylitis Patients","primary_completion_date":"2018-09-24","study_type":"Observational","rec_status":"Completed","completion_date":"2018-12-06","last_update":"2018-12-27","description":"The study is intended to provide additional post-marketing safety data regarding the use of etoricoxib for the indication of ankylosing spondylitis.","other_id":"0663-159","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Probability Sample","gender":"All","minimum_age":16,"population":"Out-patients in Sweden with SpA/AS who took etoricoxib, other COX-2 inhibitors, or nsNSAIDs\r\n        from 2001-2010.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Participant attended an out-patient clinic 2001-2010.\r\n\r\n          -  Participant is registered with an International Classification of diseases (ICD,\r\n             Version 10)-code corresponding to SpA/AS and AS.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Not applicable.\r\n      ","sponsor":"Merck Sharp & Dohme Corp.","sponsor_type":"Industry","conditions":"Spondylarthropathies; Spondylitis, Ankylosing","interventions":[{"intervention_type":"Drug","name":"Drug: etoricoxib","description":"Patients with SpA/AS who took etoricoxib"},{"intervention_type":"Drug","name":"Drug: Other COX-2 inhibitor","description":"Patients with SpA/AS who took other COX-2 inhibitors"},{"intervention_type":"Drug","name":"Drug: nsNSAIDs","description":"Patients with SpA/AS who took nsNSAIDs"}],"outcomes":[{"outcome_type":"primary","measure":"Number of patients with Characteristics of inflammatory SPA/AS","time_frame":"Over a 12 year period (2001-2013)"},{"outcome_type":"primary","measure":"Number of patients who used etoricoxib","time_frame":"Up to 7 1/2 years (Q3 2005 - 2013)"},{"outcome_type":"primary","measure":"Number of patients who used other COX-2 inhibitors","time_frame":"Up to 7 1/2 years (Q3 2005 - 2013)"},{"outcome_type":"primary","measure":"Number of patients who used nsNSAIDs","time_frame":"Up to 7 1/2 years (Q3 2005 - 2013)"},{"outcome_type":"primary","measure":"Number of clinical outcomes of special interest","time_frame":"Up to 7 1/2 years (Q3 2005 - 2013)"}]}
{"nct_id":"NCT01264627","start_date":"2011-02-01","phase":"N/A","enrollment":99,"brief_title":"A New Translational Tool for Studying the Role of Breathing in Meditation","official_title":"Project Inspire: A New Translational Tool for Studying the Role of Breathing in Meditation","primary_completion_date":"2017-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-08-31","last_update":"2020-11-24","description":"A recent National Health Interview Survey reported that breathing exercises were the second most common complementary and alternative medicine practice in the United States, following only the use of \"natural products.\" With such widespread interest in breathing exercises, alone or as a component of practices such as meditation, a need exists for research that examines not only its efficacy, but also investigates potential mechanisms of action. Indeed, a recent National Center for Complementary and Alternative Medicine (NCCAM) Meditation Workshop recommended research to clarify biological pathways by which meditation practices, including breathing exercises, can impact health. To explore mechanisms underlying the health effects of breathing exercises, new translational tools are needed that can measure breathing patterns in both the clinic and natural environment. The primary objective of the present proposal is the application of a new technology to the investigation of pathways by which breathing exercises can affect health. For this project, the health-related outcome measure to be studied is a major cardiovascular risk factor, blood pressure.","other_id":"1R01AT005820","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"Female","minimum_age":50,"population":"","criteria":"\n        Inclusion Criteria\r\n\r\n          -  Mean 24-hr SBP: 130-139 mmHg\r\n\r\n          -  Female\r\n\r\n          -  > 50 years of age\r\n\r\n          -  Post menopausal, defined as greater than or equal to one year without a menstrual\r\n             cycle.\r\n\r\n          -  Body Mass Index (BMI): 19-31\r\n\r\n          -  English speaking (Patients not able to read and speak English will be excluded as the\r\n             behavioral group interventions are conducted in English)\r\n\r\n          -  Has a personal physician\r\n\r\n        Exclusion Criteria (Individuals will be filtered in the KP OSCA database according to the\r\n        following ICD-9 codes):\r\n\r\n        Respiration:\r\n\r\n          -  491.X chronic Bronchitis incl COPD\r\n\r\n          -  492.X emphysema\r\n\r\n          -  493.X asthma\r\n\r\n          -  494-496; 500-519: all kinds of chronic pulmonary conditions\r\n\r\n        Cardiovascular:\r\n\r\n          -  404.9 chronic ischemic heart disease\r\n\r\n          -  425.X cardiomyopathies\r\n\r\n          -  428.X heart failure\r\n\r\n          -  430-438 cerebrovascular diseases\r\n\r\n        Kidney:\r\n\r\n          -  582-583 chronic glomerulonephritis\r\n\r\n          -  584-588 renal failure\r\n\r\n        Liver:\r\n\r\n        - 571.X chronic liver disease and cirrhosis Smoker: 305.1\r\n\r\n        Psychiatric:\r\n\r\n          -  290-299 dementia/schizophrenia/ psychoses\r\n\r\n          -  303, 304 alcohol or drug dependence\r\n\r\n          -  317-319 mental retardation\r\n\r\n        Medications:\r\n\r\n          -  All blood pressure medications\r\n\r\n          -  All tranquilizers, benzodiazepins if prescribed regularly, e.g. every month\r\n\r\n          -  All narcotics if prescribed regularly, e.g. every month\r\n\r\n        Other:\r\n\r\n        - Plan to relocate residence outside recruitment area during the intervention or follow-\r\n        period\r\n      ","sponsor":"University of California, San Francisco","sponsor_type":"Other","conditions":"Hypertension","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Mindful Breathing (MB) Intervention","description":"The Mindful Breathing (MB)intervention is based on MBSR developed by Jon Kabat-Zinn. Participants will attend 8 individual weekly MB sessions. MB consists of closely \"following the breath,\" throughout inhalation and exhalation, sustaining moment-to-moment awareness on the breathing process, and passively observing thoughts, affective states, from a non-evaluative or judgmental perspective. As attention wanders to concerns or thoughts, participants will be instructed to acknowledge and accept these without evaluation and return the focus of attention back to breathing. Participants in MB will have their breathing rate and PetCO2 monitored during the 8 training sessions with a breathing monitor."},{"intervention_type":"Behavioral","name":"Behavioral: Usual Care (UC) Control Condition","description":"This control intervention is designed to account for the effects of nonspecific factors such as enrollment in a study to enhance health with the associated expectancy effects, staff attention, and measurement procedures including the monitoring of PetCO2 and (Blood Pressure) BP, and completion of questionnaires. Participants who are randomly assigned to the Usual Care condition will receive care as usual for the management of their prehypertensive condition. UC participants will receive their usual care and have access to all Kaiser Permanente (KP) health education resources, such as KP's interactive healthcare guide, and online \"Healthy Lifestyle Programs\". We will assess the extent to which participants in both MB and UC used these resources."}],"outcomes":[{"outcome_type":"primary","measure":"Blood Pressure","time_frame":"Up to Week 25","description":"Measured using Ambulatory, 24-Hr BP monitor"},{"outcome_type":"secondary","measure":"Clinic (resting) blood pressure","time_frame":"Up to Week 25"}]}
{"nct_id":"NCT01285804","start_date":"2011-01-31","phase":"N/A","enrollment":200,"brief_title":"Impact of Using a Cuffed Endotracheal Tube on Limiting the Risk of Airway Fire","primary_completion_date":"2011-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-11-30","last_update":"2012-01-31","description":"The purpose of this study is to evaluate the impact of using a cuffed endotracheal tube (ETT) on the oxygen concentration in the oropharynx during adenoidectomy, tonsillectomy, or adenotonsillectomy. The study hypothesis is that inflation of the cuff on the ETT will eliminate contamination of the oropharynx with the inspired anesthetic gases and decrease the oxygen concentration in the oropharynx.","other_id":"IRB10-00487","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients undergoing adenoidectomy, tonsillectomy, or adenotonsillectomy.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Airway anomalies or cardiac conditions that have the potential for a complicated\r\n             anesthesia induction.\r\n      ","sponsor":"Nationwide Children's Hospital","sponsor_type":"Other","conditions":"Adenoidectomy|Tonsillectomy|Adenotonsillectomy","interventions":[{"intervention_type":"Other","name":"Other: Cuffed ETT","description":"Kimberly Clark"},{"intervention_type":"Other","name":"Other: Uncuffed ETT","description":"Kimberly Clark"}],"outcomes":[{"outcome_type":"primary","measure":"Difference in oxygen concentration in the oropharynx between cuffed and uncuffed ETT.","time_frame":"4-5 minutes after induction","description":"The oxygen and sevoflurane (anesthetic agent) concentration of the oropharynx would be measured during positive pressure ventilation immediately after intubation and then 4-5 mins. after anesthetic induction when the patient resumes spontaneous ventilation."}]}
{"nct_id":"NCT02291796","start_date":"2011-01-31","phase":"Phase 4","enrollment":100,"brief_title":"Bezafibrate for Hyperfibrinogenemia in Acute Myocardial Infarction","official_title":"Early Effect Of Bezafibrate On Fibrinogen Levels, Inflammatory Response And Clinical Impact, In Patients With ST Elevation Acute Myocardial Infarction","primary_completion_date":"2013-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-12-31","last_update":"2014-11-14","description":"Introduction: Plasma fibrinogen levels have been identified as an important risk factor for cardiovascular diseases and could have a prognostic value. Bezafibrate decreases fibrinogen levels and also the incidence of major cardiovascular events in primary prevention, but its effects in acute coronary syndrome is unknown. Hypothesis: Bezafibrate effect over statin therapy reduces fibrinogen concentrations, inflammatory response and clinical events, in patients with ST segment elevation ACS and hyperfibrinogenemia. Methods: In a randomized clinical trial, controlled with conventional therapy. Patients with ST elevation acute myocardial infarction (STEAMI) and with fibrinogen concentration >500 mg/dl at 72 h of evolution, were randomly assigned to bezafibrate 400 mg/day (group I n=50) or just conventional therapy (group II n=50). Serum fibrinogen, c reactive protein and cytokines were measured. Clinical end points were recurrence of angina or infarction, left ventricular failure, cardiovascular mortality and combined end points during hospitalization.","other_id":"R-2010-3604-17","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients >18 years of age who were admitted to the Cardiovascular Intensive Care Unit\r\n             of the Cardiology Hospital, National Medical Center, Century XXI (Mexico City) and\r\n             diagnosed with ST segment elevation ACS and hyperfibrinogenemia within 72 h of symptom\r\n             onset\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with known bezafibrate allergy,\r\n\r\n          -  previous fibrate treatments,\r\n\r\n          -  patients with cardiogenic shock,\r\n\r\n          -  hepatic failure,\r\n\r\n          -  renal failure,\r\n\r\n          -  history of neoplastic disease,\r\n\r\n          -  chronic inflammatory disease or active infectious process,\r\n\r\n          -  anti-inflammatory or immunosuppressive therapies,\r\n\r\n          -  fibrinolysis with streptokinase and\r\n\r\n          -  patients with triglyceride concentrations >150 mg/dl\r\n      ","sponsor":"Instituto Mexicano del Seguro Social","sponsor_type":"Other","conditions":"Acute Myocardial Infarction","interventions":[{"intervention_type":"Drug","name":"Drug: Bezafibrate","description":"Patients with ST elevation acute myocardial infarction (STEAMI) and with fibrinogen concentration >500 mg/dl at 72 h of evolution, were randomly assigned to bezafibrate 400 mg/day or just conventional therapy"}],"outcomes":[{"outcome_type":"primary","measure":"Fibrinogen levels","time_frame":"From hospital stay to 3 months","description":"PT-Fibrinogen HS Plus kit (Beckman Coulter, Brea, CA) to determine prothrombin time and fibrinogen and to evaluate extrinsic pathway of coagulation in citrated human plasma using an auto-analyzer ACL-800 (Cobas, Roche Diagnostics, Indianapolis, IN) where fibrinogen levels are determined through turbidimetry."},{"outcome_type":"primary","measure":"Inflammatory response","time_frame":"From hospital stay to 1 month","description":"Concentration of cytokines (IL-8, IL-1β, IL-6, IL-10, TNF e IL-12) measured by ELISA system (Biosource)"},{"outcome_type":"secondary","measure":"Recurrence of major cardiovascular events","time_frame":"From hospital stay to 1 month","description":"angina, reinfarction, heart failure, death, and combined endpoints"},{"outcome_type":"secondary","measure":"Safety of treatment with bezafibrate (Any side effect that comes with the intake of bezafibrate)","time_frame":"From hospital stay to 1 month","description":"Any side effect that comes with the intake of bezafibrate"}]}
{"nct_id":"NCT01071694","start_date":"2011-01-31","enrollment":0,"brief_title":"QOLBET Quality Of Life in Patients With Early Relapsing-remitting Multiple Sclerosis Treated With BETaferon in Korea","official_title":"QOLBET Quality Of Life in Patients With Early Relapsing-remitting Multiple Sclerosis Treated With BETaferon in Korea","primary_completion_date":"2012-12-31","study_type":"Observational","rec_status":"Withdrawn","completion_date":"2012-12-31","last_update":"2012-04-16","description":"This study is to describe the quality of life of Korean patients with early relapsing-remitting multiple sclerosis during the initial 1 year of treatment with Betaferon with several validated questionnaires.","other_id":"15110","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Tertiary hospital","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Relapsing-remitting MS (RRMS) patients within the first two years after diagnosis\r\n             according to Poser or McDonald criteria, starting Betaferon treatment, including\r\n             patients switching from other DMDs\r\n\r\n          -  Patients who signed informed consent form\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Age lower than 18\r\n      ","sponsor":"Bayer","sponsor_type":"Industry","conditions":"Multiple Sclerosis, Relapsing-Remitting","interventions":[{"intervention_type":"Drug","name":"Drug: Interferon beta 1-b (Betaferon/Betaseron, BAY86-5046)","description":"Patients receiving Betaferon according to routine clinical practice"}],"outcomes":[{"outcome_type":"primary","measure":"Quality of life evaluated by several validated questionnaire","time_frame":"Baseline, 3, 6, 9, 12 months (+/- 1 month)"},{"outcome_type":"secondary","measure":"Information about safety of Betaferon in routine clinical use","time_frame":"Baseline, 3, 6, 9, 12 months (+/- 1 month)"}]}
{"nct_id":"NCT01273246","start_date":"2011-01-31","phase":"Phase 1","enrollment":132,"brief_title":"Safety of an Inactivated Enterovirus Type 71 Vaccines in Healthy Children","official_title":"A Blind, Randomized and Placebo-controlled Clinical Trial With Inactivated Enterovirus Type 71 Vaccines in Healthy Children.","primary_completion_date":"2011-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-07-31","last_update":"2021-07-28","description":"A Phase I clinical trialto evaluate the safety of an Inactivated Enterovirus Type 71 Vaccine in healthy children (3-11y) and infants (6-35m).","other_id":"EV71-1001-Ib","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":0.5,"maximum_age":11,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Healthy males and females, aged from 6 months to 11 years old Health is determined by\r\n             medical history, physical examination, laboratory examination and clinical judgment of\r\n             the investigator\r\n\r\n          2. Provided legal identification for the sake of recruitment.\r\n\r\n          3. Subjects and/or parent(s)/legal guardian(s) are able to understand and sign informed\r\n             consents.\r\n\r\n          4. Birth weight more than 2500 grams\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Histroy of Hand-foot-mouth Disease\r\n\r\n          2. Subject that has allergic history of vaccine, or allergic to any ingredient of vaccine\r\n\r\n          3. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory\r\n             difficulty, angioedema, or abdominal pain\r\n\r\n          4. Congenital malformations or developmental disorders, genetic defects, or severe\r\n             malnutrition\r\n\r\n          5. Epilepsy, seizures or convulsions history, or family history of mental illness\r\n\r\n          6. Autoimmune disease or immunodeficiency, or parents, brothers and sisters have\r\n             autoimmune diseases or immunodeficiency\r\n\r\n          7. History of asthma, angioedema, diabetes or malignancy\r\n\r\n          8. History of thyroidectomy or thyroid disease that required medication within the past\r\n             12 months\r\n\r\n          9. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or\r\n             platelet disorder requiring special precautions) or significant bruising or bleeding\r\n             difficulties with IM injections or blood draws\r\n\r\n         10. Asplenia, functional asplenia or any condition resulting in the absence or removal the\r\n             spleen\r\n\r\n         11. Acute illness or acute exacerbation of chronic disease within the past 7 days\r\n\r\n         12. Any history of immunosuppressive medications or cytotoxic medications or inhaled\r\n             corticosteroids within the past six months (with the exception of corticosteroid nasal\r\n             spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated\r\n             dermatitis)\r\n\r\n         13. History of any blood products within 3 months\r\n\r\n         14. Administration of any live attenuated vaccine within 28 days\r\n\r\n         15. Administration of subunit or inactivated vaccines ,e.g., pneumococcal vaccine, or\r\n             allergy treatment within 14 days\r\n\r\n         16. Axillary temperature > 37.0 centigrade before vaccination\r\n\r\n         17. Abnormal laboratory parameters before vaccination\r\n\r\n         18. Any medical, psychiatric, social condition, occupational reason or other\r\n             responsibility that, in the judgment of the investigator, is a contraindication to\r\n             protocol participation or impairs a volunteer's ability to give informed consent\r\n      ","sponsor":"Sinovac Biotech Co., Ltd","sponsor_type":"Industry","conditions":"Hand-foot-mouth Disease|Infection; Viral, Enterovirus","interventions":[{"intervention_type":"Biological","name":"Biological: 100U inactivated Enterovirus Type 71 Vaccine","description":"Inactivated Enterovirus Type 71 Vaccine, 100U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm"},{"intervention_type":"Biological","name":"Biological: 200U inactivated Enterovirus Type 71 Vaccine","description":"Inactivated Enterovirus Type 71 Vaccine, 200U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm"},{"intervention_type":"Biological","name":"Biological: 400U inactivated Enterovirus Type 71 Vaccine","description":"Inactivated Enterovirus Type 71 Vaccine, 400U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm"},{"intervention_type":"Biological","name":"Biological: Placebo","description":"Placebo, all components of the trial vacccine except for the Enterovirus Type 71 virus antigen, 0.5ml per dose. Placebo will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm"}],"outcomes":[{"outcome_type":"primary","measure":"To evaluate the safety of the inactivated Enterovirus Type 71 Vaccine","time_frame":"6 months","description":"All adverse events were records. Blood cell and biochemistry were performed."},{"outcome_type":"secondary","measure":"To evaluate the immunogenicity of the inactivated Enterovirus Type 71 Vaccine","time_frame":"6 months","description":"virus neutralization assays were performed."}]}
{"nct_id":"NCT02571179","start_date":"2011-01-31","phase":"Phase 4","enrollment":20,"brief_title":"Intranasal Fentanyl in Treatment of Labour Pain","official_title":"Intranasal Fentanyl in Treatment of Labour Pain - Efficacy and Safety","primary_completion_date":"2017-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2017-12-31","last_update":"2017-04-12","description":"Physiological changes during pregnancy are known to affect the pharmacokinetics of many drugs. Intranasal fentanyl is an interesting option for obstetric analgesia, but its use in pregnant patients has not been established. The investigators studied pharmacokinetics of intranasal fentanyl in labouring women and to subsequently evaluate the maternal and fetal safety after administration.","other_id":"KUH12_04_2010","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","intervention_model_description":"Intranasal fentanyl","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  healthy parturients with uncomplicated, single gestation pregnancies, full term (38-42\r\n             weeks of gestation) pregnancy, agreed to participate\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  a disease that might affect hepatic or renal function, contraindications to opioid\r\n             analgesics, fetal growth retardation, signs of fetal asphyxia by cardiotocography,\r\n             meconium stained amniotic fluid or placental insufficiency. The subjects should not\r\n             have received fentanyl during the previous 14 days.\r\n\r\n        Not agreed to participate\r\n      ","sponsor":"Kuopio University Hospital","sponsor_type":"Other","conditions":"Labor Pain","interventions":[{"intervention_type":"Drug","name":"Drug: intranasal fentanyl 50 microg dose up to 250 microg","description":"When contraction pain was  5/10 (numerical rating scale 0= no pain, 10= worst pain), the parturient was given a intranasal fentanyl 50 g dose. After 15 minutes, if contraction pain was still  5/10, a second 50 g intranasal dose was administered. Fentanyl was administered every 15 minute until contraction pain decreased to less than 5/10 or until the maximum fentanyl dose of 250 g was administered."}],"outcomes":[{"outcome_type":"primary","measure":"Fentanyl maximum concentration","time_frame":"From the first intranasal fentanyl dose to birth of the newborn up to 48 hours"}]}
{"nct_id":"NCT01215864","start_date":"2011-01-31","phase":"Phase 1","enrollment":28,"brief_title":"Study of Intravenous TCD-717 in Patients With Advanced Solid Tumors","official_title":"A Multicenter Phase I Study of TCD-717 Given by 4-Hour Intravenous Infusion in Patients With Advanced Solid Tumors","primary_completion_date":"2014-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-02-28","last_update":"2014-08-08","description":"This is a Phase I dose escalation study of TCD-717, a novel drug that is a specific inhibitor of the enzyme choline kinase alpha, in patients with advanced solid tumors. The objectives of this study are to evaluate the safety of the drug and to determine the maximum tolerated dose and appropriate dose for phase II studies. Secondary objectives are to measure the efficacy of TCD-717; and in a substudy to be conducted in the MTD confirmation cohort only, to evaluate the potential correlation between the levels of tumor choline and tumor response to the choline kinase alpha inhibitor, TCD-717, using magnetic resonance spectroscopy. Pharmacokinetics analysis will be performed on patients enrolled in the maximum tolerated dose confirmation cohort.","other_id":"T10-10646","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patients must have histologically-confirmed solid tumors, metastatic or recurrent and\r\n             refractory after standard therapy for the disease or for which conventional therapy is\r\n             not reliably effective or no effective therapy is available.\r\n\r\n          2. Where possible, it is recommended that a paraffin block of tumor tissue or slides\r\n             containing sections of tumor tissue be available (a sample should be collected and\r\n             stored appropriately for the potential evaluation of choline kinase alpha expression\r\n             in tumor tissue at the end of the study).\r\n\r\n          3. Patients must be  18 years of age.\r\n\r\n          4. Patients must have an ECOG Performance Status of 0, 1 or 2 and an estimated life\r\n             expectancy of  12 weeks.\r\n\r\n          5. Patients must have adequate clinical laboratory values (i.e., absolute neutrophil\r\n             count 1.5x10^9/L, platelets 100x10^9/L, plasma creatinine <= 1.5 x upper limit of\r\n             normal (ULN) for the institution or a calculated creatinine clearance (using Cockroft\r\n             and Gault formula) of  60 mL/min/1.73 m^2; bilirubin < 1.5 x ULN, alanine\r\n             transaminase (ALT) and aspartate transaminase (AST) < 2.5 x ULN or  5 x ULN with\r\n             liver involvement.\r\n\r\n          6. Patients may have either measurable or non-measurable disease as defined by RECIST.\r\n\r\n          7. Patients must give signed informed consent prior to the start of any study specific\r\n             procedures.\r\n\r\n          8. Female patients with reproductive potential must have a negative serum or urine\r\n             pregnancy test.\r\n\r\n          9. Patients with reproductive potential and their partners must be using at least one\r\n             form of contraception as approved by the Investigator prior to study entry.\r\n\r\n         10. Patients with central nervous system metastases may be included if they are stable\r\n             without administration of steroids. Patients with unstable metastatic CNS disease are\r\n             excluded.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients will be excluded if they have received previous anti-cancer chemotherapy,\r\n             immunotherapy, vaccines, monoclonal antibodies, anti-angiogenic therapy, radiotherapy\r\n             or any other investigational therapy within 4 weeks (6 weeks for nitrosoureas or\r\n             mitomycin C) prior to study entry. Patients receiving concurrent anticancer therapy or\r\n             intending to receive this at any time during the study will be excluded.\r\n\r\n          2. Patients who have received extensive prior radiotherapy to more than 30% of bone\r\n             marrow reserves, or prior bone marrow/stem cell transplantation at any time prior to\r\n             the study.\r\n\r\n          3. Patients with any concomitant condition that could compromise the objectives of this\r\n             study and the patient's compliance.\r\n\r\n          4. Patients with significant cardiac disease including heart failure that meets New York\r\n             Heart Association (NYHA) class III and IV definitions, history of myocardial\r\n             infarction within six months of study entry, uncontrolled dysrhythmias or poorly\r\n             controlled angina, uncontrolled hypertension or elevated heart rate.\r\n\r\n          5. Patients with a history of serious ventricular arrhythmia (VT or VF), QTc >=450 msec\r\n             for men and 470 msec for women (as indicated in the ECG taken in the pre-treatment\r\n             evaluation), or left ventricular ejection fraction (LVEF)<=50% by MUGA or\r\n             Echocardiogram performed at the pre-treatment evaluation.\r\n\r\n          6. Pregnant or lactating females.\r\n\r\n          7. Patients with clinically evident HIV, HBV or HCV infection.\r\n\r\n          8. Patients with a hematologic malignancy.\r\n\r\n          9. Patients with a documented or known bleeding disorder or who require anticoagulation\r\n             treatment that increases international normalized ratio (INR) or activated partial\r\n             thromboplastin time (aPTT) above the institutional upper limit of normal.\r\n\r\n         10. Patients with clinically significant retinal abnormalities as per the medical history\r\n             or ophthalmologic findings in the pre-treatment evaluation (e.g., retinitis pigmentosa\r\n             or macular degeneration).\r\n      ","sponsor":"Traslational Cancer Drugs Pharma, SL","sponsor_type":"Industry","conditions":"Advanced Solid Tumors","interventions":[{"intervention_type":"Drug","name":"Drug: TCD-717","description":"Patients will receive TCD-717 at the following dose levels:\r\n2, 4, 7, 10, 14, 19, 25, 31, 39, 49 or 61 mg/m^2"}],"outcomes":[{"outcome_type":"primary","measure":"Safety of TCD-717 given by 4-hour intravenous infusion","time_frame":"Duration of the study","description":"Patients will be monitored throughout the study for adverse events and dose limting toxicities."},{"outcome_type":"secondary","measure":"Antitumor activity of TCD-717 given by 4-hour intravenous infusion","time_frame":"Duration of study","description":"Efficacy of TCD-717 will be asessed by RECIST 1.1"},{"outcome_type":"secondary","measure":"MTD confirmation cohort only: Pharmacokinetics (PK) of TCD-717 given by 4-hour infusion","time_frame":"Day 1-28 of Cycle 1","description":"For patients enrolled in MTD confirmation cohort, PK (Cmax, Tmax, AUC) will be measured during Cycle 1"},{"outcome_type":"secondary","measure":"To evaluate the potential correlation between the levels of tumor choline and tumor response to the choline kinase alpha inhibitor TCD-717 using magnetic resonance spectroscopy (MRS) (Substudy, MTD confirmation cohort only).","time_frame":"First scan will be pre-treatment (within 2 wks prior to start of treatment), then on Cycle 1 Day 25, and then within 7 days after determining disease progression","description":"MTD confirmation cohort only"}]}
{"nct_id":"NCT01284244","start_date":"2011-01-31","phase":"N/A","enrollment":36,"brief_title":"A Randomized Controlled Trial of the Uresta Continence Pessary","official_title":"A Randomized Controlled Trial of the Uresta Continence Pessary; Short-term Uresta Efficacy Study (SURE Study)","primary_completion_date":"2013-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-05-31","last_update":"2017-03-31","description":"Stress urinary incontinence (SUI) is defined as the involuntary loss of urine with an increase in abdominal pressure, caused either by a loss of support under the bladder neck, or intrinsic urethral sphincter deficiency. It is a common problem in women that can significantly impact quality of life, with up to 30% developing SUI at some point in their lifetime. The most commonly utilized treatments for SUI include either pelvic floor (Kegel) exercises, or surgery. Many women find Kegel exercises unsatisfactory, but are reluctant to undergo a surgical procedure. Also, women who are poor candidates for surgery have limited options if Kegel exercises are unsuccessful. Over the years, there have been numerous attempts to develop effective non-surgical alternatives for treating SUI, but the results have been variable and the available data on efficacy limited. A new intravaginal incontinence pessary (Uresta) has been developed for treating stress incontinence, and is currently available in Canada via a medical distributor. The self-positioning device is initially fitted by a healthcare provider, but then can subsequently placed by the patient as needed. Uresta is designed to be easily inserted into the vagina and spontaneously fall into position, providing support beneath the urethra. A single, uncontrolled study of 21 women showed that Uresta significantly reduces urinary incontinence measures, with no reported complications. Using questionnaires, a 47% reduction in self-reported SUI symptoms was demonstrated. Pad weight following a pad test, an objective assessment of urine loss, showed a 50% reduction in leakage. This trial is intended to be a short-term assessment of the efficacy of the Uresta device, using a placebo arm in order to remove any of the possible sources of patient biases. The placebo (\"sham\") group will be obtained by placing a flexible silastic ring (inactivated Estring) high in the vagina where it will not alter urethral forces. The aim is to unequivocally determine whether the Uresta device provides the necessary urethral support to stop urine leakage from stress incontinence. The hypothesis is that the Uresta device will significantly reduce urinary losses from baseline, shown as a significant reduction pad weight following a pad test with the device in place.","other_id":"100131A","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Urodynamic diagnosis of stress urinary incontinence\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Urodynamic diagnosis of mixed incontinence\r\n\r\n          -  Bladder capacity less than 300mls\r\n\r\n          -  Post-void residual over 100mls\r\n\r\n          -  Pelvic organ prolapse greater than POP-Q stage 2\r\n\r\n          -  Hematuria\r\n\r\n          -  Undiagnosed vaginal bleeding\r\n\r\n          -  Current pregnancy\r\n\r\n          -  Previous incontinence or prolapse surgery\r\n\r\n          -  Failed use of an incontinence pessary\r\n\r\n          -  Physically unable to perform the activities included in the pad test\r\n      ","sponsor":"Mount Sinai Hospital, Canada","sponsor_type":"Other","conditions":"Stress Urinary Incontinence","interventions":[{"intervention_type":"Device","name":"Device: Uresta pessary","description":"Participants randomized to the Uresta group will be fitted with device before immediately before performing the pad test. The Uresta pessary is made of medical grade rubber that has been extensively tested for safety. It is bell-shaped, with a narrow tip that allows for easy insertion into the vagina in a similar fashion to a tampon. The device can be easily inserted, and removed by a patient for use when needed. The Uresta comes in 3 sizes. Fitting starts with insertion of the smallest size. If urine leakage continues with valsalva or a cough stress test, it can be replaced by one size larger, until leakage is stopped. If the device prevents the patient from being able to void or is uncomfortable due to its size, the smaller size is replaced. Following the pad test, the participant will be given the opportunity to keep the device for continued use, or remove it if desired."},{"intervention_type":"Device","name":"Device: Silastic ring","description":"The silastic ring is a plastic flexible ring similar to that used to administer vaginal estrogen (Estring). It is well tolerated and would not contain any medications. Immediately before performing the pad test, it would be placed high in the vagina, away from the urethra. It would be removed immediately after the pad test. Draping will conceal from the patient which device was inserted."}],"outcomes":[{"outcome_type":"primary","measure":"A 50% Reduction in Pad Test Weight","time_frame":"Immediately after device placement (short term).","description":"A pad test is an objective measure of urine loss. With a full bladder, while wearing a pad, the participant completes five repetitions of the following physical activities: coughing, step climbing, heel bounce, standing from a sitting position and walking 50 yards. The weight of the pad is then determined.\r\nThe primary outcome variable will be the achievement of a 50% reduction in the pad weight before and after device placement. This figure is obtained from the study by Farrell et al, where pad weight decreased from 20 grams to 9 grams with the use of the Uresta device."}]}
{"nct_id":"NCT01188447","start_date":"2011-01-31","phase":"N/A","enrollment":4034,"brief_title":"Evaluation of the Safety of C-Spine Clearance by Paramedics","official_title":"Evaluation of the Safety of C-Spine Clearance by Paramedics","primary_completion_date":"2015-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-09-30","last_update":"2017-08-04","description":"The goal of this cohort study is to evaluate the safety and potential impact of an active strategy that allows paramedics to assess very low-risk trauma patients with the Canadian C-Spine Rule (CCR) and transport them to the Emergency Department without immobilization. The specific objectives of the study are to determine safety, determine the clinical impact and evaluate performance.","other_id":"2009142-01H","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":16,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  consecutive alert, stable adults evaluated by the paramedics with potential c-spine\r\n             injury after sustaining acute blunt trauma. Patient eligibility will be determined at\r\n             the time of paramedic arrival at the scene based on the following criteria:\r\n\r\n          -  \"Potential c-spine injury after sustaining acute blunt trauma\" will include patients\r\n             with either:\r\n\r\n               -  neck pain with any mechanism of injury (subjective complaint by the patient of\r\n                  any pain in the posterior aspect of the neck),\r\n\r\n               -  no neck pain but some visible injury above the clavicles, and/or\r\n\r\n               -  neither neck pain nor visible injury, but significant mechanism of injury as\r\n                  determined by the paramedic at the scene.\r\n\r\n          -  \"Alert\" is defined as a Glasgow Coma Scale score of 15 (converses, fully oriented, and\r\n             follows commands).\r\n\r\n          -  \"Stable\" refers to normal vital signs(systolic blood pressure 90 mm Hg or greater and\r\n             respiratory rate between 10 and 24 breaths per minute).\r\n\r\n          -  \"Acute\" refers to injury within the past 4 hours.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients under the age of 16 years,\r\n\r\n          -  Patients with penetrating trauma from stabbing or gunshot wound,\r\n\r\n          -  Patients with acute paralysis (paraplegia, quadriplegia),\r\n\r\n          -  Patients with known vertebral disease (ankylosing spondylitis, rheumatoid arthritis,\r\n             spinal stenosis, or previous cervical spine surgery), or\r\n\r\n          -  Patients referred from another hospital and transported between facilities.\r\n      ","sponsor":"Ottawa Hospital Research Institute","sponsor_type":"Other","conditions":"Fracture of Cervical Spine","interventions":[{"intervention_type":"Procedure","name":"Procedure: Canadian C-Spine Rule","description":"Paramedics will apply a validated decision rule (the Canadian C-spine Rule) to determine whether or not immobilization is required for trauma patients being transported to the emergency department."}],"outcomes":[{"outcome_type":"primary","measure":"Adverse Events","time_frame":"within 30 days of enrollment","description":"Measures of safety will include:\r\nnumber of missed cervical spine injuries\r\nnumber of serious adverse outcomes"},{"outcome_type":"secondary","measure":"Clearance Rate","time_frame":"Measures of clinical impact will be assessed immediately following the patient's Emergency Department visit","description":"Proportion of eligible low-risk patients transported without immobilization"},{"outcome_type":"secondary","measure":"Performance of the Canadian C-Spine Rule","time_frame":"Rule accuracy will be within 30 days of enrollment. Paramedic accuracy of interpretation and agreement will be assessed immediately following enrollment.","description":"Measurements of the performance of the rule will include:\r\nrule accuracy\r\nparamedic accuracy of interpretation\r\nparamedic agreement and level of comfort with the decision suggested by the Canadian C-Spine Rule"},{"outcome_type":"secondary","measure":"Scene Time","time_frame":"immediately following evaluation","description":"Time spent at scene (difference between Paramedic scene departure and arrival at patient side)"},{"outcome_type":"secondary","measure":"Average Contact Time","time_frame":"immediately following evaluation","description":"Total time spent with patient (Defined as difference between Transfer of Care and Arrival at Patient Side)"}]}
{"nct_id":"NCT01735643","start_date":"2011-01-31","phase":"Early Phase 1","enrollment":220,"brief_title":"Lifestyle Intervention With an Interactive Video Game for Type 2 Diabetes Patients","official_title":"Spielend zu Mehr Bewegung - Lebensstilintervention Durch Das Interaktive Video-spiel \"Wii Fit Plus\" Bei Personen Mit Typ-2-Diabetes Mellitus","primary_completion_date":"2012-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-09-30","last_update":"2012-11-28","description":"Due to overweight and unhealthy lifestyle the number of patients with type 2 diabetes mellitus is increasing. Although in early phases the disease might be successfully treated by lifestyle change patients lack for motivation. Instead of increasing anti-diabetic medication a highly motivational system with low inhibition threshold is needed. Therefore, the investigators analyzed if regular use of the interactive videogame Wii Fit Plus over 12 weeks is able to improve HbA1c and weight in patients with type 2 diabetes.","other_id":"Wii study","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":50,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  type 2 diabetes mellitus\r\n\r\n          -  diabetes duration < 5 years\r\n\r\n          -  age 50-75 years\r\n\r\n          -  body mass index > or equal to 27 kg/m2\r\n\r\n          -  participating in the disease management programme type 2 diabetes mellitus\r\n\r\n          -  physical and mental able for study participation\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  insulin or antidiabetic medication (exception: Metformin and DPP-IV-Inhibitors)\r\n\r\n          -  regular physical activity\r\n\r\n          -  depression\r\n\r\n          -  tumors\r\n\r\n          -  change of smoking status during the past 6 months or during the study\r\n\r\n          -  participation in other studies during the past 6 months\r\n      ","sponsor":"West German Center of Diabetes and Health","sponsor_type":"Other","conditions":"Type 2 Diabetes Mellitus","interventions":[{"intervention_type":"Device","name":"Device: interactive videogame Wii Fit Plus","description":"Use of the interactive videogame Wii Fit Plus fr 12 weeks."},{"intervention_type":"Other","name":"Other: waiting","description":"waiting for 12 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"HbA1c","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"weight","time_frame":"12 weeks"}]}
{"nct_id":"NCT02080962","start_date":"2011-01-31","phase":"Phase 2","enrollment":10,"brief_title":"Hypofractionated Radiotherapy for Nonmelanoma Skin Cancer","official_title":"Hypofractionated Radiotherapy for Nonmelanoma Skin Cancer: Study Phase II Clinical Trial","primary_completion_date":"2014-02-28","study_type":"Interventional","rec_status":"Terminated","completion_date":"2014-02-28","last_update":"2014-03-07","description":"Radiotherapy is a treatment considered standard for non melanoma skin cancer. This institution uses schemes of 4 to 6 weeks of treatment. The objective of the study is to perform radiation therapy in 1 to 2 weeks, depending on the size of the lesion.","other_id":"399/2010","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Cosmesis not important\r\n\r\n          -  Basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of any differentiation\r\n\r\n          -  Clinical stage I and II\r\n\r\n          -  Location on the thorax, abdomen, pelvis (except perineum), arm, thigh, cheek\r\n\r\n          -  Patient with up to 3 injuries eligible for the study\r\n\r\n          -  Karnofsky Performance Status (KPS)  70%\r\n\r\n          -  Age > 18 years\r\n\r\n          -  Informed Consent signed by the patient consenting to undergo the study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Indian Race\r\n\r\n          -  Prior treatment for their skin cancer\r\n\r\n          -  More than three synchronous lesions to treatment with RT\r\n\r\n          -  Basal syndrome, xeroderma, vitiligo and albinism\r\n\r\n          -  Immunosuppression\r\n\r\n          -  Prior burn at the tumor site\r\n\r\n          -  Tumor > 5 cm\r\n\r\n          -  Age <18 years\r\n\r\n          -  Carrier mental incapacity\r\n\r\n          -  People in a relationship of dependence as prisoners, soldiers, students, staff, etc..\r\n      ","sponsor":"Barretos Cancer Hospital","sponsor_type":"Other","conditions":"Non-melanoma Skin Cancer","interventions":[{"intervention_type":"Radiation","name":"Radiation: 30 Gy in 5 fractions","description":"5 fractions of 600 cGy, once a day, five times a week - TDF: 89"},{"intervention_type":"Radiation","name":"Radiation: 40 Gy in 10 fractions","description":"tumors > 2-5 cm in diameter: 10 fractions of 400 cGy, once a day, five times a week - TDF: 96"}],"outcomes":[{"outcome_type":"secondary","measure":"Quality of Life","time_frame":"Second week and twelfth week after initiation of radiotherapy","description":"EORTC QLQ-C30"},{"outcome_type":"primary","measure":"Rate of complete remission with hypofractionated RT schemes for NMSC.","time_frame":"Second week and twelfth week after initiation of radiotherapy","description":"RECIST criteria\r\nComplete Response: disappearance of the lesion\r\nPartial Response: Reduction ≥ 30% of the larger initial diameter of the lesion\r\nProgressive Disease: ≥ 20% increase in the largest initial diameter of the lesion\r\nStable disease: not increase enough to consider disease progression or reduction sufficient to consider a partial response."},{"outcome_type":"secondary","measure":"Toxicity","time_frame":"Second week and twelfth week after initiation of radiotherapy","description":"Late Effects of Normal Tissue (LENT) SOMA Toxicity Grading and Common Terminology Criteria for Adverse Events (CTCAE) version 3.0."}]}
{"nct_id":"NCT01663259","start_date":"2011-01-31","phase":"N/A","enrollment":43,"brief_title":"Reduced-intensity Therapy for Oropharyngeal Cancer in Non-smoking HPV-16 Positive Patients","official_title":"Reduced-intensity Therapy for Advanced Oropharyngeal Cancer in Non-smoking Human Papilloma Virus (HPV)-16 Positive Patients","primary_completion_date":"2019-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-09-30","last_update":"2021-01-19","description":"Taking into account the excellent prognosis of patients with HPV-positive oropharyngeal cancer with < 10 pack-year smoking, the investigators hypothesize that reducing the intensity of therapy for these patients will reduce treatment sequelae, notably long-term dysphagia, without affecting their cure rates. The main Aim is to assess whether reducing treatment intensity, by replacing concurrent chemotherapy with cetuximab, will indeed achieve improved long-term toxicity. The primary objectives include the following: to confirm that reducing treatment intensity in patients with HPV-related oropharyngeal cancer and < 10 pack-year smoking history by replacing concurrent chemotherapy with concurrent cetuximab, does not significantly increase the proportion of patients whose tumors recur, compared to our previous experience in similar patients receiving chemo-RT and to compare the toxicity in patients receiving cetuximab-RT to similar patients treated with 7 weeks of chemotherapy concurrent with RT (\"standard therapy\") in UMCC 2-21.","other_id":"UMCC 2009.078","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients must have pathologically-confirmed, previously untreated,stage\r\n             III-IV(excluding N3 or T4) squamous cell carcinoma of the oropharynx, without evidence\r\n             of distant metastasis\r\n\r\n          -  Pretreatment tumor biopsy with sufficient tumor for HPV or p16 analysis is required.\r\n             The tumor must be HPV(+) or p16(+)\r\n\r\n        Smoking history <10 pack-year or equivalent (including cigarettes, cigars, pipes, chewing\r\n        tobacco, and/or marijuana). One cannabis joint is equivalent to 5 cigarettes. (Aldington\r\n        etal, Thorax 2007; 62:1058-1063). Smoking status definitions (National Health Interview\r\n        Survey and Behavioral Risk Factor Surveillance System (Nelson DE etal al, Am J Pub Health\r\n        2003;93:1335):\r\n\r\n          -  Smokers: smoking now every day or some days in past month\r\n\r\n          -  Quitters: at least 100 cigarettes/lifetime and not smoking in the past 1-12 months\r\n\r\n          -  Former smoker: at least 100 cigarettes/lifetime and not smoking >12 months\r\n\r\n          -  Never smokers: <100 cigarettes (or equivalent)/lifetime\r\n\r\n               -  KPS > 80 (see Appendix A)\r\n\r\n               -  Patients must undergo pre-treatment endoscopic tumor staging and PET-CT scanning\r\n\r\n               -  Laboratory criteria:\r\n\r\n          -  WBC > 3500/ul\r\n\r\n          -  granulocyte > 1500/ul\r\n\r\n          -  Platelet count > 100,000/ul\r\n\r\n          -  Total Bilirubin < 1.5 X ULN\r\n\r\n          -  AST and ALT < 2.5 X ULN\r\n\r\n               -  Creatinine clearance >30 cc/min\r\n\r\n               -  Patients must sign study specific informed consent\r\n\r\n               -  Patients must have, in the opinion of a treating physician, tumor that is\r\n                  accessible to biopsy in the clinic.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior head and neck malignancy or history of other prior non-head and neck malignancy\r\n             (excluding skin cancer and early stage treated prostate cancer) within the past 3\r\n             years\r\n\r\n          -  Prior head and neck radiation or chemotherapy\r\n\r\n          -  Any medical or psychiatric illness, which in the opinion of the principal\r\n             investigator, would compromise the patient's ability to tolerate this treatment or\r\n             limit compliance with study requirements\r\n\r\n          -  Patients residing in prison\r\n\r\n          -  Patients with prior anti-epidermal growth-factor receptor antibody therapy (antibody\r\n             or small molecule)\r\n      ","sponsor":"University of Michigan Rogel Cancer Center","sponsor_type":"Other","conditions":"Squamous Cell Carcinoma of the Oropharynx|HPV","interventions":[{"intervention_type":"Drug","name":"Drug: Cetuximab","description":"Before Radiotherapy patients you will receive a single loading dose of cetuximab. Patients will also have two additional biopsies before and after cetuximab to determine how the tumor is affected. A Cetuximab infusion will also be delivered once a week during radiotherapy.Radiation will be started (70 Gy in 35 fractions over 7 weeks to the gross tumor, 50-60 Gy to subclinical target volumes) five days a week until the total dose of radiation prescribed by the doctor is reached. Radiation will be delivered concurrent with weekly cetuximab 250 mg/m2, delivered on Monday or Tuesday each week. In order to evaluate swallowing problems from radiotherapy, patients will undergo an evaluation of swallowing by videofluoroscopy (VF). Quality of Life questionnaires will be given before therapy and periodically up to 36 months after therapy. In order to assess if the tumor was completely eradicated, CT-PET scan will be performed 3 months after the completion of therapy."},{"intervention_type":"Radiation","name":"Radiation: Radiotherapy","description":"Radiation will be started (70 Gy in 35 fractions over 7 weeks to the gross tumor, 50-60 Gy to subclinical target volumes) five days a week until the total dose of radiation prescribed by the doctor is reached. Radiation will be delivered concurrent with weekly cetuximab 250 mg/m2, delivered on Monday or Tuesday each week."}],"outcomes":[{"outcome_type":"primary","measure":"Rate of Recurrence","time_frame":"2 years","description":"Number of patients whose tumors recur (includes local, regional, and distant recurrence; and second primaries).\r\nNote: Research indicates that freedom from local and regional progression (FFLRP) is a more meaningful measure. Therefore, the percentage of patients with FFLRP is included below as a Post-Hoc measure."},{"outcome_type":"secondary","measure":"Number of Participants With Adverse Events","time_frame":"3 years","description":"In order to evaluate the toxicity in patients receiving cetuximab-RT, adverse events were clustered into three categories: None, Mild-Moderate (grade 1 or 2), and Severe (grade 3 or 4). Graded according to the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4)."},{"outcome_type":"secondary","measure":"Treatment Related Toxicities","time_frame":"3 years","description":"Toxicities are measured by number of participants who experience one or more types or indicator of toxicity, shown as all grades and grades 3-4. As each participant could have multiple toxicities, the number of incidents outnumbers the number of participants. Toxicities graded according to the CTCAE v4."},{"outcome_type":"secondary","measure":"Mean Change in Tumor Epidermal Growth Factor Receptor (EGFR)","time_frame":"Day 7","description":"The ratio (fold change) of tumor EGFR post/pre loading dose of cetuximab. Reported as the mean of fold changes across all participants who had an evaluable tumor sample."},{"outcome_type":"secondary","measure":"Mean Change in Tumor Phosphorylated EGFR (pEGFR)","time_frame":"Day 7","description":"The ratio (fold change) of tumor pEGFR post/pre loading dose of cetuximab. Reported as the mean of fold changes across all participants who had an evaluable tumor sample."},{"outcome_type":"secondary","measure":"Change in Tumor EGFR Level Relative to EGFR in Normal Mucosa","time_frame":"Day 7","description":"Normal mucosa EGFR was assessed for comparison with EGFR in tumor sample. The fold change in tumor EGFR level post/pre loading dose of cetuximab, relative to fold change in normal mucosa EGFR level post/pre loading dose of cetuximab was summarized across all participants who had an evaluable tumor sample and normal mucosa sample. The value reported is the ratio of fold change in tumor/fold change in buccal EGFR."}]}
{"nct_id":"NCT01287130","start_date":"2011-01-07","phase":"Phase 1","enrollment":10,"brief_title":"AZD6244 With Cetuximab for Solid Tumors and Colorectal Cancer","official_title":"A Phase 1 Study of AZD6244 in Combination With Cetuximab in Refractory Solid Tumors","primary_completion_date":"2013-08-27","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-08-27","last_update":"2019-12-17","description":"Background: - The experimental cancer treatment drug AZD6244 has been shown to block signals that tell cancer cells to grow. Cetuximab, a drug approved to treat cancer of the head, neck, colon, and rectum, also blocks signals that tell cancer cells to grow. Researchers are investigating the highest safe dose of AZD6244 to give with cetuximab, and will also investigate the effectiveness of this drug combination in individuals who have colorectal cancer that involves a particular protein known as the K-RAS protein. Cetuximab is not used to treat colorectal cancer with K-RAS tumors because it has not been shown to be effective, but researchers believe that adding AZD6244 to cetuximab may improve how well cetuximab works, even in people with K-RAS tumors. Objectives: - To evaluate the safety and effectiveness of AZD6244 in combination with cetuximab for solid tumors that have not responded to standard treatment. - To evaluate the safety and effectiveness of AZD6244 in combination with cetuximab for colorectal cancer that involves the K-RAS protein and has not responded to standard treatment. Eligibility: - Individuals at least 18 years of age who have been diagnosed with solid tumors that have not responded to standard treatment. - Individuals at least 18 years of age who have been diagnosed with colorectal cancer that has not responded to standard treatment. Design: - This protocol will involve two separate studies: an initial study to establish the highest safe and effective dose of AZD6244 and cetuximab in individuals with solid tumors, and an expansion study of AZD6244 and cetuximab in individuals with colorectal cancer involving the K-RAS protein. - Participants will be screened with a full medical history and physical examination, blood samples, imaging studies, and other tests as required by the researchers. - AZD6244 is a capsule to be swallowed once or twice a day, every day, with water on an empty stomach. Cetuximab will be given intravenously once a week, over 2 hours for the first dose and over an hour for every following dose. This combination of daily AZD6244 and weekly cetuximab will be repeated in 28-day cycles of treatment. Participants will keep a diary to record the time of taking AZD6244 each day, as well as any side effects. - Participants will have frequent blood tests and other exams during the first cycle of treatment, up to five visits to the National Institutes of Health (NIH) and other visits to their local doctor to in the first 28-day cycle. - During subsequent cycles, participants will have four visits to NIH and four visits to your local doctor for examinations, blood tests, and imaging studies. - Participants may continue to receive the AZD6244 with cetuximab for up to 6 cycles, until the tumor grows, unacceptable side effects development, or the participant or participant's doctor decides to stop participation. There will be a final study visit that repeats the procedures performed during the screening visit....","other_id":"110075","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":99,"population":"","criteria":"\n        -  INCLUSION CRITERIA:\r\n\r\n          -  In the dose escalation cohorts: Patients must have histologically confirmed malignancy\r\n             that is metastatic or unresectable and for which standard curative or palliative\r\n             measures do not exist or are no longer effective. Histology can be based on either the\r\n             primary tumor or metastases.\r\n\r\n          -  In the MTD expansion cohort: Patients must have biopsy proven K-RAS mutant, metastatic\r\n             colorectal cancer that has progressed on at least 2 prior standard therapies. K-RAS\r\n             mutation status must be verified by a CLIA-certified laboratory. (NOTE: colorectal\r\n             patients enrolled during the dose escalation portion do not need to be K-RAS mutant in\r\n             order to be eligible).\r\n\r\n          -  Patients must be at least 4 weeks since prior chemotherapy, 6 weeks if the last\r\n             regimen included nitrosureas or mitomycin C. Prior radiation is allowed as long as the\r\n             radiation was completed 4 weeks prior to study treatment and no more than 35% of\r\n             marrow irradiated.\r\n\r\n          -  Age greater than or equal to18 years. Because no dosing or adverse event data are\r\n             currently available on the use of AZD6244 in combination with cetuximab in patients\r\n             less than 18 years of age, children are excluded from this study, but will be eligible\r\n             for future pediatric phase 1 combination trials.\r\n\r\n          -  ECOG performance status less than or equal to 2 (Karnofsky >60%).\r\n\r\n          -  Life expectancy of greater than 3 months.\r\n\r\n          -  Patients must have normal organ and marrow function as defined below:\r\n\r\n               -  Leukocytes greater than or equal to 3,000/mcL\r\n\r\n               -  absolute neutrophil count greater than or equal to 1,500/mcL\r\n\r\n               -  platelets greater than or equal to 100,000/mcL\r\n\r\n               -  total bilirubin within normal institutional limits\r\n\r\n               -  AST(SGOT)/ALT(SGPT) less than or equal to 2.5 X institutional upper limit of\r\n                  normal (AST and ALT less than or equal to 5.0 X institutional upper limit of\r\n                  normal will be permitted if liver metastases are present)\r\n\r\n               -  creatinine less than or equal to to to1.5X institution upper limit of normal OR\r\n                  creatinine clearance greater than or equal to 45 mL/min/1.73 m2, as calculated by\r\n                  Cockroft-Gault formula, for patients with creatinine levels above institutional\r\n                  normal. May use a 24 hr. urine collection to determine creatinine clearance.\r\n\r\n          -  Patients may have received prior cetuximab.\r\n\r\n          -  Patients with brain metastases that have been treated and stable for 2 months will be\r\n             eligible for this study.\r\n\r\n          -  Subjects undergoing anti-coagulation therapy with LMWH and warfarin are eligible.\r\n             Subjects receiving both warfarin and AZD6244 should have more frequent PT/INR\r\n             monitoring (see section 10.0)\r\n\r\n        EXCLUSION CRITERIA:\r\n\r\n          -  Patients who have had chemotherapy, radiotherapy or hormonal therapy within 4 weeks (6\r\n             weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have\r\n             not recovered (less than or equal to grade 1) from adverse events due to agents\r\n             administered more than 4 weeks earlier.\r\n\r\n          -  Concurrent treatment with an investigational agent other than the investigational\r\n             agent(s) used in this study OR treatment within 4 weeks of study entry with any\r\n             investigational agent(s) or device(s).\r\n\r\n          -  Failure to recover fully (as judged by the investigator) from prior surgical\r\n             procedures.\r\n\r\n          -  History of allergic reactions attributed to compounds of similar chemical or biologic\r\n             composition to AZD6244 or other agents used in study.\r\n\r\n          -  Patients taking high doses (more than recommended daily dose) of vitamin E will be\r\n             excluded. Patients can discontinue use of high dose vitamin E prior to study entry to\r\n             be considered eligible.\r\n\r\n          -  Any condition (e.g., gastrointestinal tract disease resulting in an inability to take\r\n             oral medication or a requirement for IV alimentation, prior surgical procedures\r\n             affecting absorption, or active peptic ulcer disease) that impairs their ability to\r\n             swallow and retain AZD6244 capsules.\r\n\r\n          -  Patients with malabsorption syndrome, disease significantly affecting gastrointestinal\r\n             function, or resection of the stomach or small bowel are excluded. Subjects with\r\n             ulcerative colitis, inflammatory bowel disease, or a partial or complete small bowel\r\n             obstruction are also excluded.\r\n\r\n          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active\r\n             infection, symptomatic congestive heart failure, uncontrolled hypertension, prior\r\n             cardiomyopathy, LVEF less than 50%, unstable angina pectoris, cardiac arrhythmia (i.e.\r\n             atrial fibrillation), or psychiatric illness/social situations that would limit\r\n             compliance with study requirements.\r\n\r\n          -  Pregnant women are excluded from this study because AZD6244 is a small molecule kinase\r\n             inhibitor with the potential for teratogenic or abortifacient effects. Because there\r\n             is an unknown but potential risk for adverse events in nursing infants secondary to\r\n             treatment of the mother with AZD6244, breastfeeding should be discontinued if the\r\n             mother is treated with AZD6244. These potential risks may also apply to other agents\r\n             used in this study.\r\n\r\n          -  HIV-positive patients on combination antiretroviral therapy are ineligible because of\r\n             the potential for pharmacokinetic interactions with AZD6244. In addition, these\r\n             patients are at increased risk of lethal infections when treated with\r\n             marrow-suppressive therapy. Appropriate studies will be undertaken in patients\r\n             receiving combination antiretroviral therapy when indicated.\r\n\r\n          -  Patients who are serologically positive for Hepatitis B or C, or have a history of\r\n             liver disease, other forms of hepatitis or cirrhosis are ineligible.\r\n\r\n          -  Use of strong CYP1A2 or 3A4 inducers and/or inhibitors (for example, but not limited\r\n             to, ketoconazole, rifampacin, atazanavir, clarithromycin, indinavir, itraconazole,\r\n             nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin (TAO),\r\n             voriconazole, grapefruit or grapefruit juice, ifabutin, rifapentine, phenytoin,\r\n             carbamazepine, phenobarbital and St. John's Wort) is not permitted while on study or\r\n             within 7 days prior to study enrollment.\r\n      ","sponsor":"National Cancer Institute (NCI)","sponsor_type":"NIH","conditions":"Colonic Neoplasms|Cancer of the Colon|Colon Cancer|Colon Neoplasms|Colonic Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Cetuximab","description":"Day 1 administer cetuximab 400 mg/m2 IV loading dose over 120 minutes. On days 8, 15 and 22 administer cetuximab 250 mg/m2 IV loading dose over 60 minutes"},{"intervention_type":"Drug","name":"Drug: AZD6244","description":"Given orally once or twice a day depending on dose level.On days 1, 8, 15 and 22. Repeat every 28 days"}],"outcomes":[{"outcome_type":"primary","measure":"To determine the dose limiting toxicities and the maximum tolerated dose of AZD6244 in combination with cetuximab in advanced, refractory solid tumors.","time_frame":"Two year"},{"outcome_type":"primary","measure":"To assess for evidence of anti-tumor activity with this combination, per tumor measurements","time_frame":"Two year"},{"outcome_type":"secondary","measure":"To evaluate the pharmacokinetics of AZD6244 and cetuximab when administered concomitantly","time_frame":"Two years"},{"outcome_type":"secondary","measure":"To evaluate the safety and tolerability of the combination of AZD6244 and cetuximab in patients with K-RAS mutated metastatic colorectal cancer","time_frame":"Two years"}]}
{"nct_id":"NCT01535287","start_date":"2011-01-04","phase":"Phase 4","enrollment":140,"brief_title":"Effect of Dexmedetomidine on Emergence Agitation in Children With or Without Tube Insertion Under General Anesthesia","official_title":"The Effect of Intramuscular Dexmedetomidine on Emergence Agitation in Children Undergoing With or Without Tube Insertion Under General Anesthesia","primary_completion_date":"2013-10-08","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-10-08","last_update":"2018-07-09","description":"The investigators are inviting your child to participate in this research study because your child is having myringotomy (putting a tiny incision in the eardrum with or without tube insertion) under general anesthesia. The purpose of this study is to determine whether a single injection of Dexmedetomidine (study medication) decreases the frequency of awaking from anesthesia frightened or agitated in children having myringotomy surgery as compared to those children who receive placebo (sterile saltwater).","other_id":"201006723","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":1,"maximum_age":10,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  ASA I or II (American Society of Anesthesiology classification ASA I means patients\r\n             without systemic disease, ASA II means patients with one controlled systemic medical\r\n             disease eg: Diabetes, Hypertension.)\r\n\r\n          -  Between the ages of 1 and 10 years\r\n\r\n          -  Undergoing BMT under general anesthesia.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  ASA III or higher (Patients with 2 or more medical systemic disease that is not under\r\n             control, eg: uncontrolled Diabetes)\r\n\r\n          -  Congenital diseases\r\n\r\n          -  Coagulation disorders\r\n\r\n          -  Known allergic reaction to dexmedetomidine\r\n\r\n          -  Serious preexisting impairment of respiratory, cardiovascular, hepatic, renal,\r\n             neurological or endocrine functions\r\n\r\n          -  Severe upper airway infection\r\n\r\n          -  Predicted difficult airway\r\n\r\n          -  Preexisting psychiatric disorders\r\n      ","sponsor":"Martin Mueller","sponsor_type":"Other","conditions":"Myringotomy","interventions":[{"intervention_type":"Drug","name":"Drug: Dexmedetomidine","description":"Active study agent: Dexmedetomidine at 1 microgram/kilogram Intramuscular (IM) Placebo study agent: Same volume as the study drug of placebo (normal saline).\r\nAll blinding, labeling, preparation, storage of agents done by the pharmacist. The drug will be administered into the deltoid muscle by using a TB syringe attached to a 3/4 inch length and 25 Gauge width needle by anesthesia provider after the induction of general anesthesia by the anesthesia provider."}],"outcomes":[{"outcome_type":"primary","measure":"Participant's Severity of Emergent Agitation (EA) Using the Pediatric Anesthesia Emergence Delirium (PAED) Scale in PACU (Post-Op Area).","time_frame":"Participants will be followed for the duration of first PACU recovery step, an expected average visit of 30 minutes. Measurements will be observed immediately following subject's awakening from anesthesia.","description":"The aim/measurement of the study is to determine whether or not a single IM injection of Dexmedetomidine will reduce the severity of Emergent Agitation (EA) in children undergoing Bilateral Myringotomy with/without tubes under general anesthesia.\r\nWe used the only validated scale to assess the severity of post operative emergence delirium in pediatrics. This Pediatric Anesthesia Emergence Delirium (PAED) scale is a composite score of the following items:\r\nMakes eye contact with caregiver.\r\nChild's actions are purposeful.\r\nChild aware of his/her surroundings.\r\nThe child is restless.\r\nThe child is inconsolable.\r\nItems 1, 2, and 3 are reversed scored as follows: 4-not at all, 3-a little, 2-quite a bit, 1-very much, 0-extremely. Items 4 and 5 are scored as follows: 0-not at all, 1-a little, 2-quite a bit, 3-very much, 4-extremely.\r\nThe total score will range from 0 to 20; with 0 indicating no emergence delirium and 20 indicating extreme emergence delirium."},{"outcome_type":"secondary","measure":"Duration of Stay in PACU","time_frame":"Participants will be followed immediately following surgery, approximately 30 minutes. Measurements will be observed immediately following subject's awakening from anesthesia.","description":"Duration of stay in the PACU (Post-Op Area) until discharge criteria are met based on modified PADSS score: level of consciousness, physical activity, hemodynamic stability, respiratory stability, oxygen saturation status, post-operative pain, and post-operative emetic symptoms. Duration of time will be measured in total minutes participate is in PACU until discharged."},{"outcome_type":"secondary","measure":"Respiratory Complications Peri-Operative","time_frame":"Participants will be followed for the duration immediately following surgery, approximately 30 minutes. Measurements will be observed immediately following subject's awakening from anesthesia by Anesthesia staff.","description":"Postoperative adverse respiratory events: moderate to severe coughing, oxygen desaturation (SPO2 <90%), breath holding, bronchospasm, aspiration, stridor and/or laryngospasm during PACU duration to discharge. The adverse respiratory events and the adverse hemodynamic events will be documented by the anesthesia provider in the operating room and by the recovery room nurses in the PACU recovery room. All will be blinded to the drug administered. Measurement will be obtained by \"yes\"/\"no\" to each possible adverse respiratory event by anesthesia staff."},{"outcome_type":"secondary","measure":"Hemodynamic Instability","time_frame":"Participants will be followed for the duration immediately following surgery, approximately 30 minutes. Measurements will be observed immediately following subject's awakening from anesthesia by Anesthesia staff.","description":"Postoperative adverse hemodynamic events: bradycardia-a decrease in heart rate, hypotension-a decrease in systolic blood pressure (both determined as a 30% decrease from baseline) during PACU duration to discharge. The adverse hemodynamic events will be documented by the anesthesia provider in the operating room and by the recovery room nurses in the PACU recovery room. All will be blinded to the drug administered.Measurement will be obtained by \"yes\"/\"no\" to each possible adverse respiratory event by anesthesia staff."},{"outcome_type":"secondary","measure":"Post-Operative Behavioral Disturbances","time_frame":"Participants will be followed for the duration immediately following surgery, approximately 30 minutes, through approximately Day 3 post-surgery. Measurements will be observed immediately following subject's awakening from anesthesia by Anesthesia staff.","description":"Behavioral disturbances analyzed are: sleep disturbances, anxiety, eating disturbances. These post-operative behavioral disturbances are not considered an adverse event. Data regarding postoperative behavioral disturbances will be collected by a blinded individual in a telephone interview 3 days after the surgery. Any \"other adverse event\" (not including serious) will also be documented by the telephone interview. Measurement will be obtained by \"yes\"/\"no\" to each possible AE by staff based on parent(s) response. \"Other adverse events\" (not including serious) reported immediately post-operatively includes: 1. allergic reaction to medication, 2. Respiratory distress, 3. Bronchospasms 4. Laryngospasm, 5. Hemodynamic instability"},{"outcome_type":"secondary","measure":"Muscle Pain","time_frame":"Participants will be followed for the duration immediately following surgery, approximately 30 minutes, through approximately Day 3 post-surgery. Measurements will be observed immediately following subject's awakening from anesthesia by Anesthesia staff.","description":"Postoperative muscle pain or swelling at the drug injection site. The duration of the stay in the PACU will be retrospectively documented by the research team using EPIC. Data regarding postoperative muscle pain or swelling will be collected by a blinded individual in a telephone interview 3 days after the surgery. Any adverse event will also be documented by the telephone interview. Measurement will be obtained by \"yes\"/\"no\" by staff based on parent(s) response."}]}
{"nct_id":"NCT03876574","start_date":"2011-01-01","phase":"Phase 1","enrollment":16,"brief_title":"Hepatic Artery Infusion Pump for NPC Liver Metastases","official_title":"Hepatic Artery Infusion Gemcitabine and Floxuridine in Patients With Nasopharyngeal Carcinoma Liver Metastases","primary_completion_date":"2017-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-12-31","last_update":"2019-03-15","description":"A retrospective clinical trial to study the safety and effectiveness of hepatic arterial infusion (HAI) in treating patients who have nasopharyngeal carcinoma metastatic to the liver. Hepatic-direction drug administration improves the control power for intra-hapatic lesions.","other_id":"NPC11330","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically confirmed nasopharyngeal carcinoma with histologically confirmed or\r\n             image diagnosed metastatic to the liver\r\n\r\n          -  Standard treatment of NPC, including radiotherapy and chemotherapy (induction\r\n             chemotherapy, concurrent chemotherapy and adjuvant chemotherapy) is performed as\r\n             desired\r\n\r\n          -  Performance status - ECOG 0-2\r\n\r\n          -  Absolute neutrophil count at least 1,200/mm^3\r\n\r\n          -  Platelet count at least 100,000/mm^3\r\n\r\n          -  Bilirubin no greater than 1.5 times upper limit of normal (ULN)\r\n\r\n          -  AST no greater than 2.5 times ULN\r\n\r\n          -  Alkaline phosphatase no greater than 2.5 times ULN\r\n\r\n          -  No pre-existing chronic hepatic disease (chronic active hepatitis or cirrhosis)\r\n\r\n          -  Creatinine no greater than ULN\r\n\r\n          -  Creatinine clearance greater than 60 mL/min\r\n\r\n          -  Not pregnant or nursing\r\n\r\n          -  Negative pregnancy test\r\n\r\n          -  Fertile patients must use effective contraception\r\n\r\n          -  Adequate oral nutrition (at least 1,500 calories/day)\r\n\r\n          -  Able to withstand major operative procedure\r\n\r\n          -  No dehydration\r\n\r\n          -  No severe anorexia\r\n\r\n          -  No frequent nausea or vomiting\r\n\r\n          -  No prior or concurrent malignancy within the past 5 years except basal cell or\r\n             squamous cell skin cancer or carcinoma in situ of any organ\r\n\r\n          -  No prior or concurrent malignancy associated with more than 10% probability of death\r\n             from malignant disease within 5 years of diagnosis\r\n\r\n          -  No concurrent immunotherapy\r\n\r\n          -  No concurrent colony-stimulating factors during the first course of study therapy\r\n\r\n          -  No more than 1 prior adjuvant systemic fluorouracil (5-FU) regimen with or without\r\n             levamisole, leucovorin calcium, or irinotecan\r\n\r\n          -  No prior hepatic artery infusion therapy with 5-FU or floxuridine\r\n\r\n          -  No prior systemic chemotherapy for metastatic disease\r\n\r\n          -  No prior or concurrent sorivudine or brivudine\r\n      ","sponsor":"Xiangya Hospital of Central South University","sponsor_type":"Other","conditions":"Nasopharyngeal Carcinoma|Neoplasm Metastasis|Liver","interventions":[{"intervention_type":"Procedure","name":"Procedure: DSA-guided implantation of hepatic artery infusion pump","description":"Implant the infusion catheter and injection port (Celsite, B. Braun, Chasseneuil, France) under DSA-guiding. The proximal end of the infusion catheter was connected to the injection port and the device was implanted in a subcutaneous pocket in the right inner thigh; the distal end of the infusion catheter guarantee uni-direction infusion to liver."},{"intervention_type":"Drug","name":"Drug: Gemcitabine","description":"Given intra-arterially for 30 minutes"},{"intervention_type":"Drug","name":"Drug: Floxuridine","description":"Given intra-arterially continuously for 14 days"},{"intervention_type":"Drug","name":"Drug: dexamethasone","description":"Given intra-arterially continuously with 5-FUDR"}],"outcomes":[{"outcome_type":"primary","measure":"Disease control rate (DCR) of intrahepatic lesions","time_frame":"2 years","description":"Assess the Disease control rate (DCR) of intrahepatic lesions by enhanced spiral-CT scan according to RECIST criteria."},{"outcome_type":"secondary","measure":"Overall survival time","time_frame":"7 years","description":"From the date of HAI catheter implantation to the date of death from any cause or to completion of trial, whichever comes first, up to 84 months."},{"outcome_type":"secondary","measure":"Side effects and adverse events","time_frame":"2 years","description":"To determine the safety and tolerability of HAI for NPC liver metastases by establishing the rates of toxicity"}]}
{"nct_id":"NCT01234831","start_date":"2010-12-31","phase":"N/A","enrollment":463,"brief_title":"A Novel Approach to Methicillin-resistant Staphylococcus Aureus (MRSA) Screening of Colonized Patients","official_title":"A Novel Approach to MRSA Screening of Colonized Patients and Impact on Hospital Resource Allocation and Patient Care","primary_completion_date":"2011-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-03-31","last_update":"2017-10-31","description":"Methicillin-resistant Staphylococcus aureus (MRSA) is endemic in hospital settings. Colonization with MRSA puts patients at increased risk for invasive infections, and MRSA infections have been associated with high costs and adverse clinic outcomes. Patients can clear MRSA spontaneously. Improved approaches for identifying patients who are no longer colonized are needed; we hypothesize that more sensitive nucleic acid amplification can be used to improve identification of patients who are no longer colonized.","other_id":"2010P001336","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  age > 18\r\n\r\n          -  last positive MRSA culture greater than 3 months old\r\n\r\n          -  admitted to hospital\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  age < 18\r\n\r\n          -  last positive MRSA culture less than or equal to 3 months old\r\n      ","sponsor":"Massachusetts General Hospital","sponsor_type":"Other","conditions":"MRSA Colonization","interventions":[{"intervention_type":"Device","name":"Device: nucleic acid amplification of nasal swab; nasal swab culture","description":"Nasal swab is performed and analyzed using nucleic acid amplification to determine the presence or absence of MRSA DNA. One nasal swab is performed each day for three consecutive days during hospitalization."},{"intervention_type":"Other","name":"Other: Nasal swab culture","description":"Nasal swabs are obtained if the clinician caring for the patient identifies the patient as eligible to be screened for colonization. An algorithm for screening eligible patients is available electronically as part of the patient's standard medical record to the clinicians providing care."}],"outcomes":[{"outcome_type":"primary","measure":"Number of Subjects With Single Negative Polymerase Chain Reaction (PCR) Result and 3 Negative Culture Assays","time_frame":"1 year","description":"This outcome is the negative predictive value of a single PCR assay for subjects with a history of prior MRSA infection or colonization."},{"outcome_type":"primary","measure":"Completion of Screening Protocol in Both Trial Arms","time_frame":"1 year","description":"Rate at which subjects in both trial arms complete the 3-swab protocol."},{"outcome_type":"primary","measure":"Discontinuation of Contact Precautions in Both Trial Arms","time_frame":"1 year","description":"Patients known to have MRSA require Contact Precautions based on current recommendations from the Center for Disease Control and Prevention (CDC). Contact Precautions mean that hospitalized patients with a history of MRSA infection or colonization are isolated in a private room or together with patients who have the same Contact Precautions status (i.e. both with MRSA). Healthcare workers caring for such patients must wear protective gowns and gloves during interactions and use of equipment dedicated to that patient is recommended. For this study, \"Contact Precautions are discontinued\" refers to the practice of discontinuation of Contact Precautions once subjects meet criteria based on institutional infection control policy: history of MRSA but no positive culture in preceding 90 days and three negative nasal surveillance cultures obtained at least 24 hours apart in the absence of concurrent antibiotic use."},{"outcome_type":"secondary","measure":"Number of Subjects With a Single Positive PCR Result and at Least 1 Positive Culture Assay","time_frame":"1 year","description":"This outcome is the positive predictive value of a single PCR assay for subjects with a history of prior MRSA infection or colonization who completed the 3 swab protocol."},{"outcome_type":"secondary","measure":"Sensitivity of First PCR Assay","time_frame":"1 year","description":"Sensitivity of the first PCR assay for subjects enrolled in active arm of trial."},{"outcome_type":"secondary","measure":"Specificity of First PCR Assay.","time_frame":"1 year","description":"Specificity of the first PCR assay for subjects enrolled in active arm of trial."},{"outcome_type":"secondary","measure":"Rate of Recolonization or Documented Infection With MRSA","time_frame":"2 years","description":"Prospective review of microbiological data for patients enrolled in the trial to determine rate of recolonization or documented infection. Subjects in the Intervention Arm of the study who had documented clearance of colonization and met criteria for discontinuation of contract precautions, and had CP discontinued by staff (N=69) were included. Subjects who had a visit at MGH through 12/31/2012 during which a microbiology sample was obtained and MRSA was recovered (clinical or surveillance) were included."}]}
{"nct_id":"NCT01176058","start_date":"2010-12-31","phase":"Phase 3","enrollment":17,"brief_title":"A Study Of The Efficacy And Safety Of Anidulafungin Vs. Fluconazole In The Treatment Of Patients With Candidemia And/Or Other Forms Of Invasive Candidiasis","official_title":"A Phase Iiib, Open-label, Randomized, Multi-center Study Of The Efficacy And Safety Of Anidulafungin Vs. Fluconazole, In The Treatment Of Subjects With Candidemia And/or Other Forms Of Invasive Candidiasis","primary_completion_date":"2011-11-30","study_type":"Interventional","rec_status":"Terminated","completion_date":"2011-11-30","last_update":"2015-10-28","description":"In the treatment of patients with candidemia and/or other forms of invasive candidiasis , Anidulafungin is at least as effective and safe as Fluconazole.","other_id":"A8851023","allocation":"Randomized","intervention_model":"Parallel Assignment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Presence of candidemia or invasive candidiasis.\r\n\r\n          -  Presence of one or more of signs and symptoms of acute fungal infection.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subjects who received greater than 48 hours of systemic antifungal treatment for the\r\n             Candida infection for which they will be enrolled.\r\n\r\n          -  Subjects with hypersensitivity to echinocandins or azole therapy or drug excipients.\r\n      ","sponsor":"Pfizer","sponsor_type":"Industry","conditions":"Candidemia","interventions":[{"intervention_type":"Drug","name":"Drug: Anidulafungin/Fluconazole","description":"Anidulafungin:IV,100 mg daily preceded by an initial 200 mg dose on Day 1, 14 - 42 days Fluconazole: IV/Oral, 400mg,QD,14 - 42 days"}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of Participants With Global Response at End of Intravenous Treatment (EOIT)","time_frame":"End of Intravenous Treatment (Up to Day 42)","description":"Global response included clinical and microbiological success or failure. Success - clinical success (defined as the resolution or significant improvement in signs and symptoms of invasive candidiasis) and microbiological success (defined as the eradication of Candida species present at baseline, as determined on follow-up culture, or the presumed eradication, if culture data were not available [N/A] for a participant with a successful clinical response).\r\nFailure - Any case that did not meet the criteria for success."},{"outcome_type":"secondary","measure":"Percentage of Participants With Global Response at End of Treatment (EOT)","time_frame":"End of Treatment (Up to Day 42)","description":"Global response included clinical and microbiological success or failure. Success - clinical success (defined as the resolution or significant improvement in signs and symptoms of invasive candidiasis) and microbiological success (defined as the eradication of Candida species present at baseline, as determined on follow-up culture, or the presumed eradication, if culture data were N/A for a participant with a successful clinical response).\r\nFailure - Any case that did not meet the criteria for success."},{"outcome_type":"secondary","measure":"Percentage of Participants With Clinical Response at EOIT","time_frame":"End of Intravenous Treatment (Up to Day 42)","description":"Clinical response included success and failure. Success included Cure (resolution of signs and symptoms of the Candida infection) and Improvement (significant, but incomplete resolution of signs and symptoms of Candida infection). Failure defined as No significant improvement in signs and symptoms or death due to Candida infection or circumstances prevented an evaluation from being made."},{"outcome_type":"secondary","measure":"Percentage of Participants With Clinical Response at EOT","time_frame":"End of Treatment (Up to Day 42)","description":"Clinical response included success and failure. Success included Cure (resolution of signs and symptoms of the Candida infection) and Improvement (significant, but incomplete resolution of signs and symptoms of Candida infection). Failure defined as No significant improvement in signs and symptoms or death due to Candida infection or circumstances prevented an evaluation from being made."},{"outcome_type":"secondary","measure":"Percentage of Participants With Clinical Response at Follow-Up","time_frame":"Post treatment follow-up visit (Up to Day 52)","description":"Clinical response included success and failure. Success included Cure (resolution of signs and symptoms of the Candida infection) and Improvement (significant, but incomplete resolution of signs and symptoms of Candida infection). Failure defined as No significant improvement in signs and symptoms or death due to Candida infection or circumstances prevented an evaluation from being made."},{"outcome_type":"secondary","measure":"Percentage of Participants With Microbiological Response at EOIT","time_frame":"End of Intravenous Treatment (Up to Day 42)","description":"Microbiological Success implies Eradication: culture negative for all Candida species present at baseline (documented), or culture data N/A (presumed). Microbiological Failure implies (1) Persistence: baseline Candida species present in repeat cultures (documented), or culture data N/A (presumed); (2) Recurrence: baseline Candida species isolated following eradication (documented), or culture data N/A (presumed); or (3) Indeterminate: culture data N/A (loss to follow-up or death that was not due to candidiasis or candidemia)."},{"outcome_type":"secondary","measure":"Percentage of Participants With Microbiological Response at EOT","time_frame":"End of Treatment (Up to Day 42)","description":"Microbiological Success implies Eradication: culture negative for all Candida species present at baseline (documented), or culture data N/A (presumed). Microbiological Failure implies (1) Persistence: baseline Candida species present in repeat cultures (documented), or culture data N/A (presumed); (2) Recurrence: baseline Candida species isolated following eradication (documented), or culture data N/A (presumed); or (3) Indeterminate: culture data N/A (loss to follow-up or death that was not due to candidiasis or candidemia)."},{"outcome_type":"secondary","measure":"Percentage of Participants With Microbiological Response at Follow-Up","time_frame":"Post treatment follow-up visit (Up to Day 52)","description":"Microbiological Success implies Eradication: culture negative for all Candida species present at baseline (documented), or culture data N/A (presumed). Microbiological Failure implies (1) Persistence: baseline Candida species present in repeat cultures (documented), or culture data N/A (presumed); (2) Recurrence: baseline Candida species isolated following eradication (documented), or culture data N/A (presumed); or (3) Indeterminate: culture data N/A (loss to follow-up or death that was not due to candidiasis or candidemia)."},{"outcome_type":"secondary","measure":"Number of Participants Who Died","time_frame":"Baseline to Day 52"}]}
{"nct_id":"NCT01317394","start_date":"2010-12-31","enrollment":60,"brief_title":"Study and Analysis of Micafungin for Non-albican Candidemia: Efficacy, Risk Factor and Clinical Manifestation","official_title":"Retrospective Study and Analysis of Micafungin for Non-albican Candidemia: Efficacy, Risk Factor and Clinical Manifestation","study_type":"Observational","rec_status":"Completed","completion_date":"2011-02-28","last_update":"2011-03-17","description":"This study is a retrospective research in order to compare and analysis the risk factor, clinical manifestation and efficacy of albicans candidemia by pulling medical records. We hope that this retrospective research will let us understand the method of treatment and prevention of albicans candidemia in order to improve the quality of healthcare.","other_id":"99078","observational_model":"Case-Only","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":20,"population":"non-albicans candidemia patients","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  above 20 years old\r\n\r\n          -  hospital patients\r\n\r\n          -  albicans candidemia patients\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  pregnant patients or patients under 16 years old\r\n\r\n          -  liver cirrhosis and Child C\r\n      ","sponsor":"Taipei Medical University WanFang Hospital","sponsor_type":"Other","conditions":"Non-albicans Candidemia","interventions":{},"outcomes":{}}
{"nct_id":"NCT01250392","start_date":"2010-12-31","phase":"N/A","enrollment":3500,"brief_title":"The Effect of Active Choice on Nurse Visit Participation","official_title":"The Effect of Time-Slot Scheduling and Active Choice on Biometric Screening and Nurse Visit Participation","primary_completion_date":"2012-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-01-31","last_update":"2012-05-18","description":"The goal of this project is to see if behavioral nudges will increase an individual's likelihood of participating in a nurse visit. The behavioral nudges under consideration are encouraging subjects to make an active choice and sending reminders.","other_id":"0001","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Harrah's employee\r\n\r\n          -  Registered e-mail address with Harrah's\r\n\r\n          -  Part of Harrah's Choosing Wellness Program\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Under 18\r\n\r\n          -  Already participated in a nurse visit\r\n      ","sponsor":"National Bureau of Economic Research, Inc.","sponsor_type":"Other","conditions":"Participation in Nurse Visits","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: The Effect of Active Choice on Nurse Visit Participation","description":"The goal of this project is to see if active choice will increase an individual's likelihood of participating in a nurse visit.\r\nThe employees in our sample will schedule their nurse visit time slot via e-mail and a health service provider website. The control group will be informed via e-mail of the window of dates during which they can take part in the on-site screening and given instructions for scheduling an appointment. The treatment group, the active choice only arm, will be given the same information as the control group, but they will also be asked to make an appointment immediately, defer the scheduling decision, or decline to receive a screening. The treatment group will also receive email reminders one week before their appointment."}],"outcomes":[{"outcome_type":"primary","measure":"Nurse Visit Participation","time_frame":"This will be measured after all of the nurse visit windows have been closed, by 4/30/11","description":"We will measure whether or not subjects scheduled and participated in a nurse visit. We will compare the number of subjects who participated in the nurse visits by treatment arms."}]}
{"nct_id":"NCT01325805","start_date":"2010-12-31","phase":"N/A","enrollment":7,"brief_title":"Efficacy of a Structured Weight Loss Program in Overweight Women With a History of Recurrent Pregnancy Loss","official_title":"Pregnancy Outcomes in Overweight and Obese Women With a History of Recurrent Pregnancy Loss Randomized to a Structured Weight Loss Program Versus Routine Weight-Loss Counseling: A Pilot Study","primary_completion_date":"2013-12-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2013-12-31","last_update":"2016-11-25","description":"Overweight and obesity has been associated with a number of adverse pregnancy outcomes in women of reproductive age, including infertility and early pregnancy loss. Recent data suggests that overweight and obese patients are also at increased risk of recurrent pregnancy loss (RPL), a devastating condition that affects 1% of the fertile population. The investigators propose a prospective, randomized controlled trial in which overweight and obese patients with unexplained recurrent pregnancy loss are enrolled in a structured, 6 month, weight loss program or provided routine counseling regarding the importance of weight loss. Pregnancy outcomes will then be followed to assess miscarriage rates. Metabolic outcomes, such as lipid and glucose profiles, will also be evaluated.","other_id":"SU-03212011-7603","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":39,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Unexplained recurrent pregnancy loss (2 or more prior miscarriages)\r\n\r\n          2. BMI >=25 kg/m2\r\n\r\n          3. Prepared to take 3 months time out from attempting to conceive\r\n\r\n          4. Ability to attend a one hour initial, then 30 minute follow-up nutrition/monitoring\r\n             session - once per week for one month, then every other week for 2 months, then once\r\n             then once per month for 3 months.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Age >=40 years\r\n\r\n          2. Diagnosis of Type 1 or Type 2 Diabetes as defined by a fasting glucose >=126, or 2\r\n             hour glucose >=200 by a 75 gram oral glucose challenge\r\n\r\n          3. Presence of an endocrine condition such as hyperprolactinemia, Cushing-s syndrome or\r\n             untreated thyroid disease (defined as a TSH outside of the laboratory determined\r\n             normal range)\r\n\r\n          4. Desire to continue attempts to conceive for the duration of the program\r\n\r\n          5. History of bariatric surgery\r\n\r\n          6. Use of over-the-counter or prescribed weight loss medications with the exception of\r\n             metformin\r\n\r\n          7. Enrollment in another clinical trial (excluding surveys)\r\n      ","sponsor":"Stanford University","sponsor_type":"Other","conditions":"Obese|Overweight|Miscarriage|Recurrent Pregnancy Loss","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Structured Weight Loss Program","description":"Those patients randomized to the structured weight loss group will have a formal evaluation and counseling a medical endocrinologist specializing in weight management. The structured weight loss program will consist of meeting with a dietician who will guide them on following a hypocaloric diet with a calorie deficit of 750kcal/day. The weight loss goal will be to lose 1-1.5 pounds/week. The participants will receive teaching utilizing the American Diabetes Association Exchange Lists and will receive sample meal plans. In addition, participants will be seen by the dietitian once a week for a month, then every 2 weeks for 2 months, then once per month for 3 months. Patients randomized to the study group will continue in the structured weight loss program for 6 months."},{"intervention_type":"Behavioral","name":"Behavioral: Routine Weight Loss Counseling","description":"Participants randomized to the routine weight loss counseling group will receive the ACOG Patient Education pamphlets on obesity."}],"outcomes":[{"outcome_type":"primary","measure":"Term live birth rate","time_frame":"2.5 years"},{"outcome_type":"secondary","measure":"Weight loss - goal for weight loss defined as 5 percent of enrollment body weight lost","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Changes in triglyceride levels","time_frame":"3 months"},{"outcome_type":"secondary","measure":"Changes in high density lipoprotein levels","time_frame":"3 months"},{"outcome_type":"secondary","measure":"Changes in alanine aminotransferase (ALT) levels","time_frame":"3 months"},{"outcome_type":"secondary","measure":"Changes in fasting insulin levels","time_frame":"3 months"},{"outcome_type":"secondary","measure":"Changes in postprandial insulin levels","time_frame":"3 months"},{"outcome_type":"secondary","measure":"Changes in fasting glucose levels","time_frame":"3 months"},{"outcome_type":"secondary","measure":"Changes in postprandial glucose levels","time_frame":"3 months"},{"outcome_type":"secondary","measure":"Changes in hemoglobin A1c levels","time_frame":"3 months"}]}
{"nct_id":"NCT01393860","start_date":"2010-12-31","enrollment":200,"brief_title":"Real-world Aliskiren Use in Diabetic Patients","official_title":"Aliskiren Use in Diabetic Patients: Who's Using it, Why, and How is it Working ?","primary_completion_date":"2011-06-30","study_type":"Observational","rec_status":"Completed","last_update":"2011-07-14","description":"The purpose of this study is to evaluate real-world patterns of aliskiren use with a focus of change in renal function following aliskiren initiation as well as to identify \"triggering events\" that lead to aliskiren initiation.","other_id":"HEORUS0081","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Diabetic patients with hypertension who were initiated on aliskiren","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Type 2 diabetes\r\n\r\n          -  Patients ages 18 yeras and older\r\n\r\n          -  Hypertension Diagnosis\r\n\r\n          -  Currently on at least 1 hypertensive medication\r\n\r\n          -  At least 2 lab measure before and after aliskiren initiation\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Inadequate chart records where microalbuminuria, serum creatinine and blood pressure\r\n             data are not within 3-12 months prior to initiation of Aliskiren\r\n\r\n          -  Pregnancy\r\n\r\n          -  Development of secondary renal disease unrelated to diabetes (such as nephritis)\r\n\r\n          -  Terminal illness\r\n\r\n          -  AIDS/HIV Other protocol-defined inclusion/exclusion criteria may apply\r\n      ","sponsor":"Novartis","sponsor_type":"Industry","conditions":"Diabetes|Hypertension","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Measure: Change in blood pressure","time_frame":"baseline and 1 year"},{"outcome_type":"secondary","measure":"Measure: Change in urine microalbumin","time_frame":"baseline and 1 year"},{"outcome_type":"secondary","measure":"Measure: Change in creatinine","time_frame":"baseline and 1 year"},{"outcome_type":"secondary","measure":"Measure: Change in potassium levels","time_frame":"baseline and 1 year"}]}
{"nct_id":"NCT03262571","start_date":"2010-12-31","phase":"Phase 3","enrollment":244,"brief_title":"Usefulness of Lung Ultrasound in Ambulatory Management of Patients With Chronic Heart Failure","official_title":"Usefulness of Lung Ultrasound in Ambulatory Management of Patients With Chronic Heart Failure","primary_completion_date":"2016-03-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2016-03-31","last_update":"2017-08-25","description":"Purpose. The aim of this study is to evaluate whether lung ultrasound, in addition to physical examination, leads to a reduction of the admission rate for acute decompensated heart failure of patients with chronic heart failure (HF) followed in the outpatients heart failure clinic. Methods. This is a prospective randomized study. The planned sample size consists of 440 patients with chronic HF. The inclusion criteria are: (1) male and female aged between 18 and 90 years (2) signed written informed consent (3) history of HF for at least six months, (4) left ventricular ejection fraction < 45%, (5) adequate medical therapy for HF for at least two months. The exclusion criteria are: (1) concomitant enrollment in other clinical studies, or treatment with experimental drugs or devices within 30 days of clinical assessment, (2) inability to undergo to the planned follow-up and procedures (3) documented pulmonary infections (3) interstitial lung disease and class 4 chronic obstructive pulmonary disease according to GOLD classification. Patients are randomized in two groups: group A, patients undergoing to lung ultrasound and physical examination; and group B, patients undergoing to physical examination only. Patients are evaluated at baseline and after three months with medical history, Quality of Life test, physical examination, blood sample for hematochemical (creatinine, electrolytes, BNP/NTpro-BNP). The diuretic therapy is then optimized according to the presence and severity of B-lines in group A and physical examination in group B. Only patients enrolled in group A undergo to a lung ultrasound examination to assess the extent of pulmonary congestion, through its evidence of B-lines. B-lines originate from the contrast between air-filled structures and water-thickened pulmonary interlobular septa. This leads to linear echogenic vertical artefacts that spread from the pleural layers downwards in the screen. The ultrasound examination is performed with a handheld echocardiography device. The physician carries out a scan of the pulmonary fields, from basal towards mid and apical fields, through the midaxillary line while the patient lies supine. The quantification of B-lines is performed according to their extent over the lung fields. All the information are recorded in dedicated forms. The results are evaluated according to the following criteria. The primary end-point is a significant reduction of hospitalizations for acute decompensated HF in group A during the follow-up period. The secondary end-points are changes of NT-proBNP values, quality of life test (QLT) score and cardiac mortality.","other_id":"B-LINES","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":90,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        (1) male and female aged between 18 and 90 years (2) signed written informed consent (3)\r\n        history of HF for at least six months, (4) left ventricular ejection fraction < 45%, (5)\r\n        adequate medical therapy for HF for at least two months.\r\n\r\n        Exclusion Criteria:\r\n\r\n        (1) concomitant enrollment in other clinical studies, or treatment with experimental drugs\r\n        or devices within 30 days of clinical assessment, (2) inability to undergo to the planned\r\n        follow-up and procedures (3) documented pulmonary infections (4) interstitial lung disease,\r\n        class 4 chronic obstructive pulmonary disease according to GOLD guidelines (5) chronic\r\n        dialysis.\r\n      ","sponsor":"IRCCS San Raffaele","sponsor_type":"Other","conditions":"Chronic Heart Failure|Lung; Congestive|Acute Decompensated Heart Failure","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Lung ultrasound","description":"Duretic therapy is then optimized according to the presence and severity of B-lines in group A."}],"outcomes":[{"outcome_type":"primary","measure":"Reduction of hospitalizations for acute decompensated heart failure","time_frame":"90 days","description":"Significant reduction of hospitalizations for acute decompensated heart failure in group A during the 90-day follow-up period."},{"outcome_type":"secondary","measure":"Natriuretic peptides values","time_frame":"90 days","description":"Significant reduction of natriuretic peptides values in group A during the 90-day follow-up period."},{"outcome_type":"secondary","measure":"Quality of life test (QLT) score","time_frame":"90 days","description":"Significant reduction of QTL score in group A during the 90-day follow-up period."},{"outcome_type":"secondary","measure":"Cardiac mortality","time_frame":"90 days","description":"Significant reduction of cardiac mortality rate in group A versus group B."}]}
{"nct_id":"NCT01268280","start_date":"2010-12-31","phase":"Phase 2","enrollment":32,"brief_title":"Pharmacodynamic Study of CK-2017357 in Patients With Generalized Myasthenia Gravis","official_title":"A Phase II, Double-Blind, Randomized, Three-Way Crossover, Placebo-Controlled, Pharmacodynamic Study of CK-2017357 in Patients With Generalized Myasthenia Gravis on Standard Therapy","primary_completion_date":"2012-10-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2012-10-31","last_update":"2019-09-24","description":"The primary objective of this early-stage clinical study is to demonstrate an effect of single doses of CK-2017357 on measures of skeletal muscle function and fatigability in patients with generalized myasthenia gravis (MG).","other_id":"CY 4023","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion criteria:\r\n\r\n          -  Ability to comprehend and willing to sign an Informed Consent Form (ICF)\r\n\r\n          -  Ability to understand written and oral English language\r\n\r\n          -  Males and females between 18 and 80 years of age, inclusive\r\n\r\n          -  Patient's signs and symptoms not better explained by another disease process\r\n\r\n          -  Established diagnosis of MG defined as clinical evidence of muscle weakness and\r\n             positive AChR-binding antibody titer (>0.02 nmol/L)\r\n\r\n          -  Myasthenia Gravis Foundation of America (MGFA) clinical classification II or III\r\n\r\n          -  Stable MG disease for 4 weeks prior to randomization\r\n\r\n          -  Ability to refrain from IVIg treatments during the course of the study\r\n\r\n          -  Ability to refrain from cholinesterase-inhibitors (e.g. pyridostigmine) for 12 hours\r\n             before each dose\r\n\r\n          -  Ability to perform all elements of the QMG\r\n\r\n          -  Grade of 2 or 3 in two or more of the following muscle groups as measured by QMG:\r\n             right or left arm flexion, head lift, and right or left leg raise at 45 Note:\r\n             Patients may re-screen if they fail due to inadequate weakness from taking\r\n             pyridostigmine within 12 hours of screening\r\n\r\n          -  Body mass index (BMI) of 18.0 to 36.0 kg/m2, inclusive\r\n\r\n          -  Pre-study clinical laboratory findings (including troponin I [TnI] and creatine\r\n             phosphokinase [CPK]) within the normal range, or if outside of the normal range,\r\n             deemed not clinically significant by the Investigator\r\n\r\n          -  For female patients only: Agreement to use a double barrier during sexual intercourse\r\n             (1 hormonal, plus 1 barrier method, or 2 simultaneous barrier methods) birth control\r\n             (birth control pills, male condom, female condom, intrauterine device, Norplant, tubal\r\n             ligation, or other sterilization procedures)\r\n\r\n          -  For male patients only: Agreement either to use a condom during sexual intercourse\r\n             with female partners who are of reproductive potential and to have female partners use\r\n             an additional effective means of contraception (e.g., diaphragm plus spermicide, or\r\n             oral contraceptives) for the duration of the study and 10 weeks after the end of the\r\n             study or to abstain from sexual intercourse for the duration of the study and 10 weeks\r\n             after the end of the study\r\n\r\n        Exclusion criteria:\r\n\r\n          -  History of chronic degenerative, psychiatric, or neurologic disorder other than MG\r\n             that can produce weakness or fatigue\r\n\r\n          -  Other major chronic or debilitating illnesses within six months prior to study entry\r\n\r\n          -  Hepatic insufficiency (defined as ALT or AST > 3x ULN, or total bilirubin > 3 mg/dL)\r\n\r\n          -  Renal insufficiency (defined as serum creatinine > 2.5 mg/dL or receiving dialysis)\r\n\r\n          -  Other myasthenic syndromes (e.g. Lambert Eaton syndrome; inherited myasthenic\r\n             syndrome)\r\n\r\n          -  Female patients who are premenopausal and are: (a) pregnant on the basis of a serum\r\n             pregnancy test, (b) breast-feeding, or (c) not using an effective method of double\r\n             barrier (1 hormonal plus 1 barrier method or 2 simultaneous barrier methods) birth\r\n             control (birth control pills, male condom, female condom, intrauterine device,\r\n             Norplant, tubal ligation, or other sterilization procedures)\r\n\r\n          -  Receipt of IVIg or plasmapheresis treatment within 6 weeks prior to the first dose of\r\n             study drug\r\n\r\n          -  Changes to immunosuppressive treatments (i.e., prednisone) within 6 weeks prior to the\r\n             first dose of study drug\r\n\r\n          -  Rituxan treatment within 3 months prior to study entry\r\n\r\n          -  Participation in any other investigational study drug or device trial in which receipt\r\n             of an investigational study drug or device occurred within 30 days prior to dosing\r\n\r\n          -  Any prior treatment with CK-2017357\r\n\r\n          -  Recent history of alcoholism or drug abuse, or significant behavioral or psychiatric\r\n             problems, or other conditions which in the Investigator's opinion may impair ability\r\n             to adequately comply with the requirements of the study\r\n      ","sponsor":"Cytokinetics","sponsor_type":"Industry","conditions":"Myasthenia Gravis","interventions":[{"intervention_type":"Drug","name":"Drug: Placebo","description":"Matching placebo in capsules administered as a single oral dose."},{"intervention_type":"Drug","name":"Drug: 250 mg CK-2017357","description":"250 mg CK-2017357 in capsules administered as a single oral dose."},{"intervention_type":"Drug","name":"Drug: 500 mg CK-2017357","description":"500 mg CK-2017357 in capsules administered as a single oral dose."}],"outcomes":[{"outcome_type":"primary","measure":"Quantitative Myasthenia Gravis score (QMG)","time_frame":"1 day","description":"A quantitative motor assessment of muscular weakness on a scale of 0 to 3 with 0 representing \"none\" and 3 representing \"severe\". Muscular assessments included in the overall score are effects on double vision, ptosis, facial muscles, swallowing, speech, outstretched arms and legs, forced vital capacity, hand grip strength, and ability to lift head."},{"outcome_type":"primary","measure":"Pulmonary Function Test (VC in liters)","time_frame":"1 day","description":"Forced Vital Capacity"},{"outcome_type":"primary","measure":"Manual Muscle Test (MMT)","time_frame":"1 day","description":"Sum of strength or function values assessed by physician on the neck, shoulder, hip and ankle"},{"outcome_type":"secondary","measure":"Characterize dose and plasma concentrations of CK-2017357 and QMG","time_frame":"2 days"},{"outcome_type":"secondary","measure":"Characterize dose and plasma concentrations of CK-2017357 and Forced Vital Capacity (FVC)","time_frame":"2 days"},{"outcome_type":"secondary","measure":"Characterize dose and plasma concentrations of CK-2017357 and Manual Muscle Test (MMT)","time_frame":"2 days"},{"outcome_type":"secondary","measure":"Number of patients with adverse events","time_frame":"4 weeks"},{"outcome_type":"secondary","measure":"Modified MG Symptom Score","time_frame":"2 days","description":"Patients will be asked questions regarding five myasthenia gravis systems including trouble using eyes, trouble eating, difficulty speaking, trouble walking and trouble performing personal grooming needs. Each of the areas is scored 0 (none at all) to 3 (very much) and the overall score combining the score of all five areas on a scale of 0 to 15 with 0 being normal and 15 being severe weakness"},{"outcome_type":"secondary","measure":"Patient Global Assessment","time_frame":"2 days","description":"Patients answer a single question as to whether they feel the same, better or worse as compared to how they felt pre-dose"},{"outcome_type":"secondary","measure":"Investigator Global Assessment","time_frame":"2 days","description":"Investigator answer a single as question as to whether they think the patient appears the same, better or worse as compared to the patient's status at pre-dose"}]}
{"nct_id":"NCT01260298","start_date":"2010-12-31","enrollment":12,"brief_title":"Protocol To Evaluate Patient Measurements After Ultrasonic Treatment","official_title":"Protocol To Evaluate Patient Measurements After Ultrasonic Treatment.","primary_completion_date":"2011-03-31","study_type":"Observational","rec_status":"Completed","completion_date":"2011-03-31","last_update":"2011-03-11","description":"The objective of this study is to observe body contour changes following treatment using the MC1 device.","other_id":"SST2010-2","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"Female","minimum_age":20,"maximum_age":50,"population":"Female between the ages of 20 and 50 years with BMI between 20 and 30 who are scheduled to\r\n        be treated using the MC1 device.","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Is female.\r\n\r\n          2. Is between 20 and 50 years of age, inclusive, on the day of enrolment.\r\n\r\n          3. Has a BMI between 20 and 30 kg/m2.\r\n\r\n          4. Is to be treated in the infra-scapular area using the MC1.\r\n\r\n          5. Has never been treated with the MC1 before.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patient is lactating, has a positive pregnancy test within 7 days of planned study\r\n             procedure (for female patients of child-bearing potential), or intends to become\r\n             pregnant during the study or is not using effective methods to prevent pregnancy.\r\n\r\n          2. Currently enrolled in another device or drug study that has not completed the required\r\n             follow-up period, or has completed all other study-required follow-up less than 30\r\n             days before enrolment in this study.\r\n\r\n          3. Keloid scars, hypertrophic scars or a history of abnormal healing.\r\n\r\n          4. Thrombophlebitis.\r\n\r\n          5. Bleeding or bruising disorders (e.g. idiopathic thrombocytopenic purpura,\r\n             anticoagulated patients).\r\n\r\n          6. Tissue ischemia in the area to be treated.\r\n\r\n          7. Hypertension or abnormally high blood pressure.\r\n\r\n          8. High cholesterol.\r\n\r\n          9. Active collagen vascular disease (e.g. fibromyalgia, panniculitis, lupus etc.).\r\n\r\n         10. Diabetes.\r\n\r\n         11. Epilepsy.\r\n\r\n         12. Tuberculosis.\r\n\r\n         13. Auxiliary electric organs (such as pacemakers), metal or myoelectric prosthesis.\r\n\r\n         14. Endocrine syndromes or thyroid hyperfunction.\r\n\r\n         15. Any type of hemorrhagic (bleeding) status.\r\n\r\n         16. Active skin infection, any infection in the treated area within the last 30 days or\r\n             skin disease in the area to be treated (e.g. eczema, psoriasis, urticaria,\r\n             dermographism).\r\n\r\n         17. Hepatic or renal insufficiency.\r\n\r\n         18. Bone, muscle or joint disease, dysfunction or healing in the area to be treated.\r\n\r\n         19. Malignancy in the area to be treated.\r\n\r\n         20. Laminectomy in the area to be treated. 5.2. Withdrawal and Replacement of Subjects\r\n      ","sponsor":"Sound Surgical Technologies, LLC.","sponsor_type":"Industry","conditions":"Females Scheduled to be Treated Using the MC1.","interventions":[{"intervention_type":"Device","name":"Device: MC1 Ultrasonic Device","description":"Ultrasonic and zonal massage device."}],"outcomes":{}}
{"nct_id":"NCT01247896","start_date":"2010-12-31","phase":"Phase 1","enrollment":26,"brief_title":"Single Dose Escalation Study of PF-05190457 in Healthy Volunteers","official_title":"A Phase 1 Placebo-controlled Trial to Assess the Safety, Tolerability, and Pharmacokinetics of Single Escalating Oral Doses of PF-05190457 Under Fasted and Fed Conditions in Healthy Adult Subjects","primary_completion_date":"2011-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-06-30","last_update":"2011-07-06","description":"PF-05190457 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The purpose of the study is to evaluate the safety and tolerability of PF-05190457 after administration of a single dose to healthy volunteers and to evaluate the plasma drug concentrations after single dose in healthy volunteers.","other_id":"B3301001","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy males and females (non-childbearing) between the ages of 18 and 55 with BMI of\r\n             17.5 to 30.5 kg/m2; and a total body weight between 50 kg (110 lbs) and 100 kg (220\r\n             lb) inclusive\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Evidence or history of clinically significant hematological, renal, endocrine,\r\n             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or\r\n             allergic disease\r\n      ","sponsor":"Pfizer","sponsor_type":"Industry","conditions":"Diabetes Mellitus, Type II","interventions":[{"intervention_type":"Drug","name":"Drug: PF-05190457","description":"Single Dose 2 mg"},{"intervention_type":"Drug","name":"Drug: PF-05190457","description":"Single Dose 10 mg"},{"intervention_type":"Drug","name":"Drug: PF-05190457","description":"Single Dose 30 mg"},{"intervention_type":"Drug","name":"Drug: PF-05190457","description":"Single Dose 100 mg"},{"intervention_type":"Drug","name":"Drug: PF-05190457","description":"Single Dose 300 mg"},{"intervention_type":"Drug","name":"Drug: PF-05190457","description":"Single Dose 600 mg"},{"intervention_type":"Drug","name":"Drug: PF-05190457","description":"Single Dose - to be determined with food"},{"intervention_type":"Drug","name":"Drug: PF-05190457","description":"Single Dose - to be determined"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Single Dose Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"Safety and tolerability of PF-05190457 will be assessed by physical examinations, adverse event monitoring, 12-lead ECGs, continuous cardiac monitoring over the first 8 hours after dosing, vital sign and clinical safety laboratory measurements","time_frame":"8 weeks"},{"outcome_type":"primary","measure":"The single dose PK of PF-05190457 will be described by estimating parameters of AUC(0-infinity), AUC(0-last), AUC(0-24), Cmax, Tmax, CL/F, Vz/F and half-life (t1/2), as the data permit","time_frame":"48 hour"},{"outcome_type":"secondary","measure":"PK of PF-05190457 in the fed condition will be described by estimating parameters of AUC(0-infinity), AUC(0-last), AUC(0-24), Cmax, Tmax, CL/F, Vz/F and half-life (t1/2),","time_frame":"48 hour"},{"outcome_type":"secondary","measure":"Gastric half-emptying time (GET½), the duration of the lag phase (Tlag), gastric emptying coefficient (GEC)","time_frame":"Day 1 for Periods 1 and 2, for Cohort 3."}]}
{"nct_id":"NCT01406327","start_date":"2010-12-14","enrollment":900,"brief_title":"Drug Use Investigation for VOLIBRIS (Ambrisentan) (Pulmonary Arterial Hypertension)","official_title":"Drug Use Investigation for VOLIBRIS (Ambrisentan) (Pulmonary Arterial Hypertension)","primary_completion_date":"2020-02-28","study_type":"Observational","rec_status":"Completed","completion_date":"2020-02-28","last_update":"2020-09-03","description":"The objective of this post-marketing surveillance study is to evaluate the incidence of adverse events in Japanese subjects with pulmonary arterial hypertension treated with ambrisentan basd on prescribing information under the conditions of general clinical practice and also to grasp the following items; 1. Unknown adverse drug reactions (ADRs) 2. Incidence of ADRs to medical products in actual clinical practice 3. Factors influencing safety of ambrisentan 4. Factors influencing efficacy of ambrisentan 5. Prognosis of subjects as well as efficacy and safety of ambrisentan in long-term use (VOLIBRIS is a trademark of Gilead Sciences, Inc,. that GSK uses under license.)","other_id":"114782","observational_model":"Other","time_perspective":"Other","sampling_method":"Probability Sample","gender":"All","population":"All Japanese subjects who have received ambrisentan for the first time for the treatment of\r\n        pulmonary arterial hypertension (PAH) and have given their consent to participate in the\r\n        study.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Must use ambrisentan for the first time\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subjects with hypersensitivity to ambrisentan\r\n\r\n          -  Subjects who is pregnant or might be pregnant\r\n\r\n          -  Subjects with severe hepatic disorder\r\n      ","sponsor":"GlaxoSmithKline","sponsor_type":"Industry","conditions":"Hypertension, Pulmonary","interventions":[{"intervention_type":"Drug","name":"Drug: Ambrisentan","description":"Ambrisentan"}],"outcomes":[{"outcome_type":"primary","measure":"The number of adverse events in Japanese subjects with pulmonary arterial hypertension treated with ambrisentan","time_frame":"1 year"},{"outcome_type":"primary","measure":"The onset statuses of anemia, fluid retention, cardiac failure and hemorrhage","time_frame":"1 year"},{"outcome_type":"primary","measure":"The number of adverse events and clinical course in subjects with hepatic dysfunction","time_frame":"1 year"}]}
{"nct_id":"NCT01199263","start_date":"2010-12-06","phase":"Phase 2","enrollment":108,"brief_title":"Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer","official_title":"A Randomized Phase II Evaluation of Weekly Paclitaxel (NSC# 673089) Versus Weekly Paclitaxel With Oncolytic Reovirus (Reolysin NSC # 729968) in the Treatment of Recurrent or Persistent Ovarian, Fallopian Tube or Primary Peritoneal Cancer","primary_completion_date":"2015-06-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-07-17","last_update":"2020-09-16","description":"This randomized phase II trial studies the side effects and how well giving paclitaxel with or without viral therapy works in treating patients with ovarian epithelial, fallopian tube, or primary peritoneal cancer that has come back. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them spreading. Viral therapy may be able to kill tumor cells without damaging normal cells. Giving paclitaxel together with viral therapy may kill more tumor cells.","other_id":"NCI-2011-02654","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients must have recurrent or persistent epithelial ovarian, fallopian tube or\r\n             primary peritoneal carcinoma; histologic documentation of the original primary tumor\r\n             is required via the pathology report\r\n\r\n          -  Patients must have measurable disease or detectable (non-measurable) disease:\r\n\r\n               -  Measurable disease is defined as at least one lesion that can be accurately\r\n                  measured in at least one dimension (longest diameter to be recorded); each lesion\r\n                  must be >= 10 mm when measured by computed tomography [CT], magnetic resonance\r\n                  imaging [MRI] or caliper measurement by clinical exam; or >= 20 mm when measured\r\n                  by chest x-ray; lymph nodes must be > 15 mm in short axis when measured by CT or\r\n                  MRI\r\n\r\n               -  Detectable (non-measurable) disease is defined as not having measurable disease\r\n                  but has at least one of the following conditions:\r\n\r\n                    -  Baseline values of CA-125 at least 2 x upper limit of normal (ULN);\r\n\r\n                    -  Ascites and/or pleural effusion attributed to tumor;\r\n\r\n                    -  Solid and/or cystic abnormalities on radiographic imaging that do not meet\r\n                       RECIST 1.1 definitions for target lesions\r\n\r\n          -  Patient with measurable disease must have at least one \"target lesion\" to be used to\r\n             assess response on this protocol as defined by RECIST 1.1; tumors within a previously\r\n             irradiated field will be designated as \"non-target\" lesions unless progression is\r\n             documented or a biopsy is obtained to confirm persistence at least 90 days following\r\n             completion of radiation therapy\r\n\r\n          -  Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG)\r\n             protocol, if one exists; in general, this would refer to any active GOG phase III\r\n             protocol or rare tumor protocol for the same patient population\r\n\r\n          -  Patients who have received one prior regimen must have a GOG performance status of 0,\r\n             1, or 2\r\n\r\n               -  Patients who have received two or three prior regimens must have a GOG\r\n                  performance status of 0 or 1\r\n\r\n          -  Recovery from effects of recent surgery, radiotherapy, or chemotherapy:\r\n\r\n               -  Patients should be free of active infection requiring antibiotics (with the\r\n                  exception of uncomplicated urinary tract infection [UTI])\r\n\r\n               -  Any hormonal therapy directed at the malignant tumor must be discontinued at\r\n                  least one week prior to registration; continuation of hormone replacement therapy\r\n                  is permitted\r\n\r\n               -  Any other prior therapy directed at the malignant tumor, including chemotherapy,\r\n                  biologic/targeted and immunologic agents, must be discontinued at least three\r\n                  weeks prior to registration\r\n\r\n          -  Patients must have had one prior platinum-based chemotherapeutic regimen for\r\n             management of primary disease containing carboplatin, cisplatin, or another\r\n             organoplatinum compound; this initial treatment may have included intraperitoneal\r\n             therapy, consolidation, non-cytotoxic agents (biologic/targeted) or extended therapy\r\n             administered after surgical or non-surgical assessment; if patients were treated with\r\n             paclitaxel for their primary disease, this can have been given weekly or every 3 weeks\r\n\r\n          -  Patients are allowed to receive, but are not required to receive, two additional\r\n             cytotoxic regimens for management of recurrent or persistent disease, with no more\r\n             than 1 non-platinum, non-taxane regimen; treatment with weekly paclitaxel for\r\n             recurrent or persistent disease is NOT allowed\r\n\r\n          -  Patients are allowed to receive, but are not required to receive, non-cytotoxic\r\n             (biologic/targeted) therapy as part of their primary treatment regimen; patients are\r\n             allowed to receive, but are not required to receive, non-cytotoxic (biologic/targeted)\r\n             therapy as part of their treatment for recurrent or persistent disease and/or as\r\n             treatment for recurrent or persistent disease; if non-cytotoxic (biologic/targeted)\r\n             therapy is given alone (i.e., not in combination with cytotoxic chemotherapy) it will\r\n             NOT count as a prior regimen\r\n\r\n               -  For the purposes of this study, poly (adenosine diphosphate [ADP]-ribose)\r\n                  polymerase (PARP) inhibitors will NOT count as a prior regimen when given alone\r\n                  (i.e., not in combination with cytotoxic chemotherapy)\r\n\r\n          -  Patients who have received only one prior cytotoxic regimen (platinum-based regimen\r\n             for management of primary disease), must have a platinum-free interval of less than 12\r\n             months, or have progressed during platinum-based therapy, or have persistent disease\r\n             after a platinum-based therapy\r\n\r\n          -  Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl\r\n\r\n          -  Platelets greater than or equal to 100,000/mcl\r\n\r\n          -  Hemoglobin greater than or equal to 9 g/dL\r\n\r\n          -  Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN)\r\n\r\n          -  Bilirubin less than or equal to 1.5 x ULN\r\n\r\n          -  Serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 3 x ULN\r\n\r\n          -  Alkaline phosphatase less than or equal to 2.5 x ULN\r\n\r\n          -  Neuropathy (sensory and motor) less than or equal to grade 1\r\n\r\n          -  Patients of childbearing potential must have a negative pregnancy test prior to the\r\n             study entry and be practicing an effective form of contraception; (pregnant women are\r\n             excluded from this study)\r\n\r\n          -  Patients must have signed an approved informed consent and authorization permitting\r\n             the release of personal health information\r\n\r\n          -  Patients must meet pre-entry requirements as specified\r\n\r\n          -  Patients must be able to avoid direct contact with severely immune-compromised\r\n             individuals such as patients who have had a recent bone-marrow or organ transplant or\r\n             patients with acquire immunodeficiency syndrome (AIDS); contact should be avoided on\r\n             the days of Reolysin treatment and for the 2 days following Reolysin treatment\r\n\r\n          -  Patients must be able to avoid direct contact with pregnant or nursing women and\r\n             infants while receiving Reolysin; contact should be avoided on the days of Reolysin\r\n             treatment and for the 2 days following Reolysin treatment\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patient who have had previous treatment with Reolysin or other oncolytic virus;\r\n             patients who have had previous treatment with weekly paclitaxel for recurrent or\r\n             persistent disease\r\n\r\n          -  Patients with a history of other invasive malignancies, with the exception of\r\n             non-melanoma skin cancer and other specific malignancies are excluded if there is any\r\n             evidence of other malignancy being present within the last three years; patients are\r\n             also excluded if their previous cancer treatment contraindicates this protocol therapy\r\n\r\n          -  Patients who have received prior radiotherapy to any portion of the abdominal cavity\r\n             or pelvis OTHER THAN for the treatment of ovarian, fallopian tube, or primary\r\n             peritoneal cancer within the last three years are excluded; prior radiation for\r\n             localized cancer of the breast, head and neck, or skin is permitted, provided that it\r\n             was completed more than three years prior to registration, and the patient remains\r\n             free of recurrent or metastatic disease\r\n\r\n          -  Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER\r\n             THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within\r\n             the last three years are excluded; patients may have received prior adjuvant\r\n             chemotherapy for localized breast cancer, provided that it was completed more than\r\n             three years prior to registration, and the patient remains free of recurrent or\r\n             metastatic disease\r\n\r\n          -  Patients with a past history of primary endometrial cancer are excluded unless all of\r\n             the following conditions are met: stage not greater than I-B; no more than superficial\r\n             myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated\r\n             subtypes, including papillary serious, clear cell or other International Federation of\r\n             Gynecology and Obstetrics (FIGO) grade 3 lesions\r\n\r\n          -  Patients with known human immunodeficiency virus (HIV) or hepatitis B or C are\r\n             excluded due to risk of viral infectivity of Reolysin therefore patients with a\r\n             pre-existent infection are not eligible\r\n\r\n          -  Patients who are receiving immunosuppressive therapy including chronic oral steroids\r\n             (at an equivalent dose of greater than prednisone 5 mg daily)\r\n\r\n          -  Women who are pregnant or nursing; pregnant women are excluded from this study;\r\n             breastfeeding should be discontinued while the mother is being treated with the agents\r\n             in this clinical trial\r\n\r\n          -  Myocardial infarction or unstable angina within 6 months of the first date of study\r\n             therapy\r\n\r\n          -  History of serious ventricular arrhythmia (i.e., ventricular tachycardia or\r\n             ventricular fibrillation) or cardiac arrhythmias requiring anti-arrhythmic medications\r\n             (except for atrial fibrillation that is well controlled with antiarrhythmic\r\n             medication)\r\n\r\n          -  Troponin > ULN\r\n\r\n          -  Baseline ejection fraction < 50% as assessed by echocardiogram or multi gated\r\n             acquisition scan (MUGA)\r\n\r\n          -  New York Heart Association (NYHA) class II or greater congestive heart failure\r\n\r\n          -  History of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or\r\n             subarachnoid hemorrhage within six months of the first date of study therapy\r\n      ","sponsor":"National Cancer Institute (NCI)","sponsor_type":"NIH","conditions":"Recurrent Fallopian Tube Carcinoma|Recurrent Ovarian Carcinoma|Recurrent Primary Peritoneal Carcinoma","interventions":[{"intervention_type":"Other","name":"Other: Laboratory Biomarker Analysis","description":"Correlative studies"},{"intervention_type":"Drug","name":"Drug: Paclitaxel","description":"Given IV"},{"intervention_type":"Biological","name":"Biological: Pelareorep","description":"Given IV"}],"outcomes":[{"outcome_type":"secondary","measure":"Tumor Response by CA125","time_frame":"Before every cycle, approximately 4.5 years.","description":"Percentage of participants with Complete and Partial Tumor Response by CA125."},{"outcome_type":"primary","measure":"Progression-free Survival (PFS)","time_frame":"Approximately 4.5 years.","description":"Time from patient entry until progression, death, or date last seen. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions"},{"outcome_type":"primary","measure":"Number of Participants With Adverse Events Grade 3 or Greater as Assessed by CTCAE Version 4.0","time_frame":"approximately 4.5 years","description":"The frequency and severity of Grade 3 and above toxicities are tabulated."},{"outcome_type":"secondary","measure":"Percentage of Participants withTumor Response by RECIST","time_frame":"approximately 4.5 years","description":"Participants with Complete and Partial Tumor Response by RECIST. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR"},{"outcome_type":"secondary","measure":"Median Overall Survival (OS) by Treatment Group","time_frame":"After patient stops protocol therapy, she is followed quarterly for 2 years, semi-annually for 3 more years, approximately 4.5 years.","description":"Time from patient randomization to death or date last seen."}]}
{"nct_id":"NCT01301495","start_date":"2010-11-30","phase":"Phase 2","enrollment":0,"brief_title":"Prospective Evaluation of a New Covered Metal Stent for Malignant Lesions of the Esophagus","official_title":"Prospective Evaluation of a New Covered Metal Stent for Malignant Lesions of the Esophagus","primary_completion_date":"2013-11-30","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2013-11-30","last_update":"2015-06-03","description":"In this study, a newly designed and FDA approved fully covered metal stents will be used to palliate 20 patients with malignant lesion of the esophagus. Dysphagia score will be assessed before and after treatment to confirm efficacy","other_id":"14989","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Inoperable malignant obstruction of the esophageal or gastric cardia\r\n\r\n          -  Malignant fistula between the esophagus ans respiratory tree\r\n\r\n          -  Recurrent cancer after prior radiation\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patient unstable for endoscopic procedure\r\n\r\n          -  Previous esophageal stenting\r\n\r\n          -  Tumor growth within 2 cm of the upper esophageal sphincter\r\n\r\n          -  Pregnant women (self reported, no pregnancy test will be done per protocol)\r\n      ","sponsor":"Weill Medical College of Cornell University","sponsor_type":"Other","conditions":"Esophageal Cancer","interventions":[{"intervention_type":"Device","name":"Device: HANAROSTENT TM covered Esophageal Stent","description":"HANAROSTENT covered Esophageal Stent for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and or extrinsic malignant tumors only and occlusion of concurrent esophageal fistula"}],"outcomes":[{"outcome_type":"primary","measure":"Palliation assessment based on Dysphagia Scores","time_frame":"2 years","description":"To evaluate if the newly fully covered metal stent , HANAROSTENT can provide adequate palliation of cancerous lesions of the esophagus;"},{"outcome_type":"secondary","measure":"Assessment of Complications and MD Anderson Dysphagia Score","time_frame":"2-4 years","description":"To determine whether it is non-inferior in efficacy and safety to the esophageal stents currently available at UVa with minimal complications and improvement of symptoms"}]}
{"nct_id":"NCT01191476","start_date":"2010-11-30","phase":"Phase 4","enrollment":336,"brief_title":"Compare Pharmaceutical Economics and Efficacy of Sevoflurane With Low Fresh Gas Flow Balanced Anesthesia, Propofol Target Controlled Infusion Anesthesia and Propofol Induction Sevoflurane Maintenance Anesthesia","official_title":"A Prospective, Randomized, Open-label Multicenter Study Comparing the Pharmaceutical Economics and Effectiveness of Sevoflurane With Low Fresh Gas Flow Balanced Anesthesia, Propofol Target Controlled Infusion Anesthesia and Propofol Induction Sevoflurane Maintenance Anesthesia in Laparoscopic Surgeries in China","primary_completion_date":"2011-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-05-31","last_update":"2012-07-03","description":"This study is being performed to compare the cost of anesthetic techniques with sevoflurane (low fresh gas flow balanced anesthesia) versus propofol (target controlled infusion [TCI]) versus propofol induction and sevoflurane maintenance anesthesia in subjects undergoing elective laparoscopic surgery with predicted anesthesic use between 1 and 3 hour duration.","other_id":"R12-564","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria\r\n\r\n          1. Men or women, aged from 18 to 65\r\n\r\n          2. ASA (American Society of Anesthesiologists) physical status (a requirement of the\r\n             subject's physical status): I or II\r\n\r\n          3. Body mass index (weight/height^2) from 16 to 30 kg/m^2\r\n\r\n          4. Elective laparoscopic surgery requiring general anesthesia managed with endotracheal\r\n             intubation\r\n\r\n          5. Duration of anesthesia use will be greater than or equal to 1 hour, but less than 3\r\n             hours in length.\r\n\r\n        Exclusion Criteria\r\n\r\n          1. Hypersensitivity or unusual response to any halogenated anesthetics.\r\n\r\n          2. History of significant cardiovascular, pulmonary, hepatic, renal, central nervous\r\n             system or muscular disease.\r\n\r\n          3. Pre-operative cognitive dysfunction or disabling neuropsychiatric disorders.\r\n\r\n          4. Need for emergency surgery or surgery requiring additional regional anesthetic\r\n             techniques.\r\n\r\n          5. Need for intracranial surgery, cardio-surgery or thoracic surgery.\r\n\r\n          6. Subjects inability to cooperate with the anesthetist before administration of the\r\n             anesthetic agent.\r\n\r\n          7. Personal or familial history of malignant hyperthermia.\r\n\r\n          8. Females who are either pregnant or breast feeding.\r\n      ","sponsor":"Abbott","sponsor_type":"Industry","conditions":"Elective Laparoscopic Surgery","interventions":[{"intervention_type":"Drug","name":"Drug: Sevoflurane Inhalational Induction and Maintenance","description":"Sevoflurane was administered at a concentration of 8% via vital capacity induction and sevoflurane 0.8-1.5 minimum alveolar concentration (MAC) with a rate of 1 L/min fresh gas flow for maintenance."},{"intervention_type":"Drug","name":"Drug: Propofol Target Controlled Infusion for Induction and Maintenance","description":"Propofol IV 4 ug/mL was administered with target controlled infusion (TCI) for induction and propofol 3 to 6 ug/mL was administered with TCI for maintenance."},{"intervention_type":"Drug","name":"Drug: Propofol Target Controlled Infusion for Induction and Sevoflurane Inhalation for Maintenance","description":"Propofol was administered as a bolus IV dose of 1.5 mg/kg for induction at a rate of 40 mg/10 seconds. During maintenance, a sevoflurane concentration of 0.8-1.5 minimal alveolar concentration (MAC) was administered at a rate of 1 L/min fresh gas flow."}],"outcomes":[{"outcome_type":"primary","measure":"Cost of Volatile Induction and Maintenance Anesthesia (VIMA) With Sevoflurane, Total Intravenous Anesthesia (TIVA) With Propofol, or Intravenous Induction With Propofol and Inhalational Maintenance With Sevoflurane","time_frame":"Anesthetic Duration between 1 to 3 Hours","description":"[Cost of VIMA = unit price of sevoflurane X used volume of sevoflurane];\r\n[Cost of TIVA = unit price of propofol X total volume of propofol in the syringe];\r\n[Cost of Propofol Induction and Sevoflurane Maintenance = unit price of propofol X total volume of propofol in the syringe + unit price of sevoflurane X volume of sevoflurane in the syringe].\r\nThe total volume of propofol in the syringe was calculated, even if all the anesthetic was not used, because it could not be reused."},{"outcome_type":"secondary","measure":"Time to Loss of Consciousness","time_frame":"Up to 10 minutes","description":"Loss of consciousness was measured from the time the anesthetic was administered until loss of consciousness (no response to command) occurred. Inhalational induction was induced with sevoflurane via vital capacity induction at 8%. Intravenous induction was induced with propofol at 4 µg/mL via target controlled infusion (TCI). In subjects who received both anesthetic agents, a bolus dose of propofol 1.5 mg/kg was used for induction."},{"outcome_type":"secondary","measure":"Time to Eye Opening","time_frame":"Every minute after anesthesia was stopped until the subjects' eyes opened","description":"Measured from the time sevoflurane or propofol administration was stopped until the subject's eyes were opened. The investigator tapped the subject on the forehead or shoulder after anesthesia was stopped and asked them to open their eyes. This process was repeated approximately every minute until eye opening occurred."},{"outcome_type":"secondary","measure":"Time to Extubation","time_frame":"Every minute after anesthesia was stopped until extubation occurred","description":"Time to extubation was measured from the time sevoflurane or propofol administration was stopped until tracheal extubation occurred. Criteria to determine extubation included a train of four stimulus > 0.9 (a method to measure the magnitude and type of neuromuscular block, a ratio of the fourth response to the first one), a tidal volume > 5 mL/kg, minute ventilation > 3 L, a respiratory rate of > 10 breaths/minute, an end tidal carbon dioxide < 45 mmHg, and eye opening has occurred."},{"outcome_type":"secondary","measure":"Time to Orientation","time_frame":"Every minute after anesthesia was stopped until orientation occurred","description":"Time to orientation was measured from the time sevoflurane or propofol administration was stopped until orientation (able to state their name and date of birth)."}]}
{"nct_id":"NCT01747759","start_date":"2010-11-30","phase":"N/A","enrollment":44,"brief_title":"Evaluation of a Preoperative Education in Total Knee Arthroplasty","primary_completion_date":"2011-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-03-31","last_update":"2012-12-12","description":"The benefit of preoperative rehabilitation treatment combining physiotherapy and targeted education for patient undergoing Total Knee replacement (TKR) is now well known. Thus, there is lack of validated booklet containing evidence based informations. Our aim is to assess the impact of an evidence based education pre-operative booklet on patient's knowledge and beliefs. The secondary objectives are to assess the impact of the booklet on patient's satisfaction on the information received, the length of stay in orthopedic surgery and the transfer rate to rehabilitation wards. To show a difference of 2 points on the knowledge score (range 0-10) between the two groups, with a = 0.05 and a power of 90%, we considered that 44 patients are needed. The evaluations will take place at baseline, the day before surgery and 6 weeks post-surgery on knowledge and beliefs scores at each visit and on a satisfaction score on the last one. Quantitative data will be compared between groups by the Kruskal-Wallis and qualitative parameters via Fisher exact test. The study protocol was approved by the local Ethic Committee.","other_id":"CHU-0133","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":55,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age ranging from 55 to 75 Planned total knee arthroplasty\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Age under 55 or above 75 Patients institutionalized Patients who have received a total\r\n             knee arthroplasty of the ipsilateral knee Patient not affiliated to a social security\r\n             scheme (beneficiary or assignee) Patients with chronic inflammatory rheumatism\r\n             Cognitive and behavioral issues Disorders of understanding and expression of the\r\n             French language TKR on complex knee\r\n      ","sponsor":"University Hospital, Clermont-Ferrand","sponsor_type":"Other","conditions":"Knee Osteoarthritis (Knee OA)","interventions":[{"intervention_type":"Other","name":"Other: Kruskal-Wallis and qualitative parameters"}],"outcomes":[{"outcome_type":"primary","measure":"knowledge score","time_frame":"at day 1"},{"outcome_type":"secondary","measure":"pain","time_frame":"Baseline"},{"outcome_type":"secondary","measure":"Primary disability","time_frame":"Baseline"},{"outcome_type":"secondary","measure":"Duration of hospitalization surgery","time_frame":"at day 1"},{"outcome_type":"secondary","measure":"Transfer rate in acute care and rehabilitation, and length of stay","time_frame":"at week 6"},{"outcome_type":"secondary","measure":"Patient's overall satisfaction towards the information received","time_frame":"at week 6"},{"outcome_type":"secondary","measure":"Patient's confidence in its own ability to achieve rehabilitation","time_frame":"at day-1"},{"outcome_type":"secondary","measure":"Patient's knowledge and beliefs about his condition","time_frame":"Baseline, at day-1 and week 6"}]}
{"nct_id":"NCT01144702","start_date":"2010-11-30","phase":"Phase 2/Phase 3","enrollment":163,"brief_title":"Effectiveness of the Association Artesunate and Mefloquine in the Treatment of Malaria by Plasmodium Falciparum","official_title":"Effectiveness of the Association Artesunate and Mefloquine in the Treatment of Uncomplicated Malaria by Plasmodium Falciparum, Juru Valley, State of Acre, Brazil, 2009.","primary_completion_date":"2013-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-07-31","last_update":"2015-05-19","description":"The purpose of this study was to evaluate the effectiveness of the fixed combination of artesunate+mefloquine in the treatment of uncomplicated malaria caused by Plasmodium falciparum in the municipality of Cruzeiro do Sul, Juru Valley, Brazil, where it was being used as specific first-line drug.","other_id":"001/ASMQ/JURUA/2009","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":0.5,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Be aged between 6 months and 70 years old;\r\n\r\n          -  Be with mono-infection confirmed laboratorial by P.falciparum;\r\n\r\n          -  Having parasite count between 250/l and 100000/l;\r\n\r\n          -  If female, not pregnant, confirmed by specific test;\r\n\r\n          -  Being feverish or report having had fever (axillary temperature >37.5C or 99,5F) in\r\n             last 48 hours;\r\n\r\n          -  Be able to receive oral medication;\r\n\r\n          -  Demonstrate interest and facility to meet the schedule of visits and monitoring for 42\r\n             days;\r\n\r\n          -  Agree to participate in the study by signature (or parents) of Consent Term;\r\n\r\n          -  Do not show evidence of severe malnutrition: underweight 60% of the weight-standard,\r\n             below-average height for age indicating malnutrition in the past and weight-height\r\n             below the average indicating dietary current deficiencies (WHO, 2006);\r\n\r\n          -  Do not show danger signals to severe malaria. Note: We will be careful to include\r\n             individuals who have used quinine or quinidine recently (three days before), because\r\n             the risk of toxicity due to interaction with mefloquine.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Present after inclusion, danger signs/symptoms for severe malaria as recommended by\r\n             the WHO;\r\n\r\n          -  Present after inclusion, laboratory evidence of mixed infection with another species\r\n             of Plasmodium;\r\n\r\n          -  Having a diagnosis of other acute infectious disease that courses with fever, such as\r\n             acute respiratory infection, common viruses of childhood diarrhea, etc;\r\n\r\n          -  Having a diagnosis of chronic co morbidities or severe disease such as cirrhosis,\r\n             chronic renal failure or heart failure;\r\n\r\n          -  Have a history of hypersensitivity to the components of the combination ASMQ.\r\n      ","sponsor":"Oswaldo Cruz Foundation","sponsor_type":"Other","conditions":"Falciparum Malaria","interventions":[{"intervention_type":"Drug","name":"Drug: artesunate & mefloquine combination","description":"A therapeutic trial of a single arm for prospective evaluation of responses of individuals with uncomplicated malaria by P. falciparum treated with combination artesunate + mefloquine for three days and monitored clinically and biochemically for 42 days."}],"outcomes":[{"outcome_type":"primary","measure":"treatment failure","time_frame":"42 days","description":"The efficacy of the treatment will be based on clinical and parasitological evaluation of the participants, conducted in all follow-up visits during the 48 days. All individuals will be classified in: a) Early treatment failure b) Late Clinical Failure, Late Parasitological Failure and adequate clinical and parasitological response. As the parasitological cure is the endpoint of treatment of malaria, all individuals classified as treatment failure should be treated with the alternative scheme (quinine + doxycycline)."},{"outcome_type":"secondary","measure":"Description of adverse events","time_frame":"42 days","description":"Any sign or symptom that is not present in the clinical evaluation of D0 and focusing on subsequent evaluations, will be defined as adverse effects of the treatment. For this, a list of signs and symptoms should be questioned participants at all follow-up visits and adverse effects identified will be properly recorded. Depending on the intensity, these adverse effects should be treated according to medical advice. The subject of the study with more severe adverse effects will be referenced to a secondary or tertiary health care for the Juruá Hospital."}]}
{"nct_id":"NCT00895882","start_date":"2010-11-30","phase":"Phase 2","enrollment":0,"brief_title":"Study to Evaluate Different Regimens of Vaniprevir (MK7009) for the Treatment of Chronic Genotype 1 Hepatitis C Virus Infection in Treatment-naive Patients (MK-7009-019)(WITHDRAWN)","official_title":"A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Different Regimens of MK7009 When Administered Concomitantly With Pegylated Interferon and Ribavirin in Treatment-Naive Patients With Chronic Genotype 1 Hepatitis C Virus Infection","primary_completion_date":"2013-01-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2013-01-31","last_update":"2015-10-22","description":"This study will evaluate the safety, tolerability, and efficacy of vaniprevir when administered concomitantly with pegylated interferon (peg-IFN) and ribavirin (RBV) to treat treatment-naive genotype 1 hepatitis C virus (HCV)-infected patients.","other_id":"7009-019","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patient has chronic genotype 1 HCV infection\r\n\r\n          -  Patient has had a liver biopsy without evidence of cirrhosis\r\n\r\n          -  Patient has had an eye exam prior to the start of study\r\n\r\n          -  Female patients capable of having children and male patients with female partners\r\n             capable of having children agree to use two forms of birth control throughout the\r\n             study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patient has had previous treatment with: 3 or more doses IFN, peg-IFN, and/or RBV; and\r\n             stopped treatment due to intolerance of one of the drugs; other antiviral or\r\n             investigational therapies or vaccines for HCV\r\n\r\n          -  Female patient is pregnant or breastfeeding\r\n\r\n          -  Patient has chronic hepatitis not caused by HCV\r\n\r\n          -  Patient has evidence of cirrhosis of the liver\r\n\r\n          -  Patient has HIV\r\n\r\n          -  Patient has active hepatitis B infection\r\n\r\n          -  Patient has non-genotype 1 HCV infection\r\n\r\n          -  Patient consumes excessive amounts of alcohol\r\n      ","sponsor":"Merck Sharp & Dohme Corp.","sponsor_type":"Industry","conditions":"Chronic Genotype 1 Hepatitis C Virus Infection","interventions":[{"intervention_type":"Drug","name":"Drug: vaniprevir (MK7009)","description":"vaniprevir 300 mg soft gel capsules twice daily."},{"intervention_type":"Drug","name":"Drug: Comparator: vaniprevir (MK7009)","description":"vaniprevir 600 mg soft gel capsules twice daily."},{"intervention_type":"Drug","name":"Drug: Comparator: Pegylated Interferon (peg-IFN) alfa-2a","description":"Peg-IFN 180 mcg/0.5 mL subcutaneous injection once weekly"},{"intervention_type":"Drug","name":"Drug: Comparator: Ribavirin","description":"Ribavirin, at a total daily dose of 1000 mg or 1200 mg based on patient weight, will be administered twice daily."},{"intervention_type":"Drug","name":"Drug: Comparator: Placebo to vaniprevir","description":"Placebo to vaniprevir soft gel capsules twice daily."}],"outcomes":[{"outcome_type":"primary","measure":"Proportion of patients achieving SVR24 in Treatment Regimens 1 to 4","time_frame":"24 weeks after end of study therapy"},{"outcome_type":"primary","measure":"Evaluate the safety and tolerability of the MK7009 treatment regiments as assessed by review of the accumulated safety data","time_frame":"72 Weeks"},{"outcome_type":"secondary","measure":"1) Proportion of patients achieving SVR24 in Treatment Regimen 5","time_frame":"1) 24 weeks after end of study therapy"}]}
{"nct_id":"NCT01239069","start_date":"2010-11-30","phase":"Phase 2","enrollment":140,"brief_title":"Safety and Efficacy Study of DE-110 Ophthalmic Suspension for the Treatment of Dry Eye Disease","official_title":"A Phase II, Prospective, Randomized, Observer-masked, Parallel-group, Multi-center Study Assessing the Safety and Efficacy of Two Concentrations Compared to Placebo for the Treatment of Dry Eye Disease","primary_completion_date":"2011-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-10-31","last_update":"2014-05-21","description":"Investigate the Safety and Efficacy of Two Concentrations of DE-110 Compared to Placebo for the Treatment of Dry Eye Disease","other_id":"30-002","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Confirmed diagnosis of dry eye\r\n\r\n          -  Not wear contact lenses during study\r\n\r\n          -  18 years or older\r\n\r\n          -  Understand and provide written consent\r\n\r\n          -  Negative pregnancy test and use acceptable method of contraception\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Use of any topical ocular medication\r\n\r\n          -  Any type of ocular surgery\r\n\r\n          -  Diagnosis of on-going ocular infection and/or allergic conjunctivitis\r\n\r\n          -  Uncontrolled systemic conditions/lid abnormalities\r\n\r\n          -  Corneal transplants\r\n\r\n          -  Females who are pregnant, nursing or planning a pregnancy\r\n\r\n          -  Participation in another drug trial concurrently or within 30 days prior to study\r\n      ","sponsor":"Santen Inc.","sponsor_type":"Industry","conditions":"Dry Eye","interventions":[{"intervention_type":"Drug","name":"Drug: DE-110 ophthalmic suspension high dose","description":"ophthalmic suspension; high dose; QID"},{"intervention_type":"Drug","name":"Drug: DE-110 ophthalmic suspension low dose","description":"ophthalmic suspension; low dose; QID"},{"intervention_type":"Other","name":"Other: Placebo","description":"DE-110 ophthalmic suspension vehicle;QID"}],"outcomes":[{"outcome_type":"primary","measure":"Efficacy of DE-110","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"Individual Response Rate","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"Individual Efficacy","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"Individual Symptoms","time_frame":"12 weeks"}]}
{"nct_id":"NCT01335516","start_date":"2010-11-30","enrollment":20,"brief_title":"Follow-up of Glypressin (Terlipressin) Clinical Efficacy in the Treatment of Bleeding Oesophageal Varices","official_title":"Follow-up of Glypressin (Terlipressin) Clinical Efficacy in the Treatment of Bleeding Oesophageal Varices","primary_completion_date":"2011-08-31","study_type":"Observational","rec_status":"Completed","completion_date":"2011-08-31","last_update":"2012-10-08","description":"Terlipressin is an effective and safe treatment for bleeding caused by rupture of oesophageal varices, which are life-threatening complications of liver cirrhosis. Oesophageal varices are abnormal dilatation of veins occurring in the lower oesophagus, which can develop in patients with cirrhosis. Bleeding caused by rupture of these varices is a life-threatening complication with mortality between 20-50%. Such bleeding can be treated with drug therapy and/or endoscopic; endoscopic therapy consists of a flexible tube equipped with a camera at the terminal end, allowing for visualizing and treating the oesophageal varices. In this study, investigators will evaluate the safety and efficacy of terlipressin - Glypressin 1 mg, powder and solvent for solution for injection. The non-interventional observational study \"Follow-up of Glypressin (terlipressin) clinical efficacy in the treatment of bleeding oesophageal varices\" aims to demonstrate that administration of Glypressin (terlipressin 1 mg) controls the bleeding in such patients.","other_id":"FE999908 CS04","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":70,"population":"60 estimated eligible participants with an age of 18-70 years, suspected or diagnosed with\r\n        bleeding oesophageal varices. Patients have cirrhosis (from any cause, any Child class) and\r\n        upper gastrointestinal haemorrhage","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Eligible patients that present an important upper gastrointestinal bleeding, being\r\n             suspected or diagnosed of liver cirrhosis, with bleeding oesophageal varices\r\n             visualized endoscopically.\r\n\r\n        (An important upper gastrointestinal bleeding is one requiring at least 2 units/24h of\r\n        transfused blood).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Septic shock\r\n\r\n          -  Patients with recent history of coronary insufficiency\r\n\r\n          -  Uncontrolled arterial hypertension\r\n\r\n          -  Chronic respiratory failure\r\n\r\n          -  Symptomatic arteritis\r\n\r\n          -  Chronic renal failure\r\n\r\n          -  Pregnant women\r\n\r\n          -  Hypersensitivity to terlipressin\r\n\r\n          -  Patients with body weight below 55 kg\r\n      ","sponsor":"Ferring Pharmaceuticals","sponsor_type":"Industry","conditions":"Gastrointestinal Bleeding|Oesophageal Varices","interventions":[{"intervention_type":"Other","name":"Other: Glypressin (terlipressin)","description":"Study drug (without placebo)"}],"outcomes":[{"outcome_type":"primary","measure":"To evaluate the clinical efficacy of Glypressin: measured by rapid control of heamorrhage; reduced mortality post-haemorrhage","time_frame":"Up to 6 months","description":"Vital signs (blood pressure, heart rate, and body temperature) and routine safety lab analysis"},{"outcome_type":"primary","measure":"To evaluate the safety profile of Glypressin: measured by number of patients with adverse events","time_frame":"Up to 6 months"},{"outcome_type":"secondary","measure":"To evaluate/monitor the ease of administration in ER","time_frame":"Up to 6 months","description":"Easiness of use in ER (easy to reconstitute, easy to administer, flexible dosage)"}]}
{"nct_id":"NCT01252589","start_date":"2010-11-30","enrollment":480,"brief_title":"Patient Reported Outcomes in Chronic Myeloid Leukemia","official_title":"Patient Reported Outcomes in Chronic Myeloid Leukemia. GIMEMA QoL - CML0310.","primary_completion_date":"2013-09-30","study_type":"Observational","rec_status":"Completed","completion_date":"2013-09-30","last_update":"2016-09-14","description":"Although the impact of disease and treatment related burden on health-related quality of life (HRQOL) in patients with solid tumours has been well studied, with several clinical trials that included HRQOL as an endpoint, the general understanding in patients with Chronic Myeloid Leukaemia (CML) is lacking in comparison. The literature shows that patients' perspective is unique and should always be measured with methodologically sound instruments that are devised for this purpose. The main scope of this project is develop to an international validated questionnaire for the purpose of HRQOL assessment; such a tool will then be used to provide important data, from the patients' perspective, to make more informed treatment decisions.","other_id":"QoL - CML0310","observational_model":"Case-Only","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Adult patients (18 years of age or older) with confirmed diagnosis of Philadelphia\r\n        chromosome positive CML undergoing all possible treatments available.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adult patients (18 years of age or older)\r\n\r\n          -  Confirmed diagnosis of Philadelphia chromosome positive CML\r\n\r\n          -  Informed consent provided\r\n\r\n          -  Patients enrolled in investigational treatment trials are eligible\r\n\r\n          -  Ability to speak and read language of the Questionnaire\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Freedom from overt cognitive impairment or major psychiatric conditions that may\r\n             confound HRQOL evaluation\r\n      ","sponsor":"Gruppo Italiano Malattie EMatologiche dell'Adulto","sponsor_type":"Other","conditions":"Chronic Myeloid Leukemia","interventions":[{"intervention_type":"Other","name":"Other: HRQOL questionnaire"}],"outcomes":[{"outcome_type":"primary","measure":"Development of an EORTC questionnaire to assess HRQOL of patients with CML.","time_frame":"By the end of the study."},{"outcome_type":"secondary","measure":"Comparison between physicians' perception of relevance of HRQOL issues with that of patients.","time_frame":"By the end of the study."},{"outcome_type":"secondary","measure":"Development of an EORTC CML symptom checklist.","time_frame":"By the end of the study."},{"outcome_type":"secondary","measure":"HRQOL in CML patients undergoing 2nd line treatment with TKIs.","time_frame":"By the end of the study."},{"outcome_type":"secondary","measure":"Decision making process for choosing between different 2nd line treatments with TKIs.","time_frame":"By the end of the study."}]}
{"nct_id":"NCT01253434","start_date":"2010-11-30","phase":"Phase 1","enrollment":80,"brief_title":"E2022 Patch Formulation Single Dose Phase I Study","official_title":"E2022 Patch Formulation Single Dose Phase I Study","primary_completion_date":"2011-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-03-31","last_update":"2013-05-14","description":"The purpose of this study is to evaluate the pharmacokinetics of a single dose of E2022 in healthy Japanese male volunteers.","other_id":"E2022-J081-001","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":20,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria\r\n\r\n          1. Body Mass Index (BMI) at Screening is 18.5 kg/m2 or above and less than 25.0 kg/m2:\r\n             BMI (kg/m2)= weight(kg)  {height(m) height(m)}\r\n\r\n          2. Subjects who are between 20 and 55 years of age at the time of obtaining written\r\n             consent.\r\n\r\n          3. Subjects who are willing to and can comply with the conditions described in the study\r\n             protocol.\r\n\r\n        Exclusion Criteria\r\n\r\n          1. Subjects who consumed caffeine-containing food or beverages within 72 hours before\r\n             study drug administration.\r\n\r\n          2. Exposure to any supplements or herbs (including Chinese medicine), or beverages (e.g.\r\n             alcohol or grapefruit-containing beverages) known to modulate CYP3A4, CYP2C9, CYP2C19,\r\n             CYP2D6, within 2 weeks before study drug administration.\r\n\r\n          3. Subjects with history of cutaneous hypersensitivity to external preparation, or those\r\n             who are on another transdermal formulation.\r\n\r\n          4. Subjects who have excessive skin hair around the region to put the patch on.\r\n\r\n          5. Subjects with skin disorder, such as eczema, skin irritation, pigment disorder, injury\r\n             or scar in the region of patch application, which may have an impact on skin findings.\r\n      ","sponsor":"Eisai Co., Ltd.","sponsor_type":"Industry","conditions":"Japanese Healthy Male Adult Volunteers","interventions":[{"intervention_type":"Drug","name":"Drug: E2022","description":"E2022 Type A patch"},{"intervention_type":"Drug","name":"Drug: E2022","description":"E2022 Type B patch"},{"intervention_type":"Drug","name":"Drug: E2022","description":"E2022 Type C patch"},{"intervention_type":"Drug","name":"Drug: E2022","description":"E2022 Type D patch"},{"intervention_type":"Drug","name":"Drug: E2022","description":"E2022 Type E patch"}],"outcomes":[{"outcome_type":"primary","measure":"Comparison of pharmacokinetics of E2022 patch (type A, B, C, D, E) with single dose of E2020 5 mg tablets.","time_frame":"15 days"}]}
{"nct_id":"NCT02640911","start_date":"2010-11-30","enrollment":3000,"brief_title":"An Observational Study on Atypical Antipsychotics Long-term Treatment Patients With Schizophrenia","primary_completion_date":"2030-05-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2033-05-31","last_update":"2021-09-14","description":"This multi-centre study will evaluate the safety and related factors study of atypical antipsychotics long-term treatment in Chinese Patients with Schizophrenia. The atypical antipsychotics include quetiapine, olanzapine, risperidone, aripiprazole, ziprasidone, paliperidone , amisulpride , perospirone and clozapine. This is an open, cohort, multi-center observational clinical study. The main purpose is to evaluate the safety. And the second purpose is to evaluate the efficacy of atypical antipsychotics. The efficacy evaluations include symptoms, social function, recurrence rate and hospitalization. This study belongs to IV period post-marketing drugs research. Planned sample size is 3000 cases. Visits occurs at 0,4,8,13,26,52,78,104,130 and 156 weeks. The main indexes include physical examination, vital signs, abdominal circumference , laboratory tests (blood cell analysis/ blood biochemical tests / prolactin (PRL) / thyroxine, etc.), adverse events, 12-lead electrocardiogram( ECG), extrapyramidal syndrome(EPS )assessment, sexual function evaluation, medication and other subjective feelings. The second indexes include scales of Positive and Negative Syndrome Scale(PANSS)Clinical Global Impression-severity of Illness Scale(CGI-S), Calgary Depression Scale for Schizophrenia(CDSS),Personal and Social Performance Scale(PSP), the MOS 36item Short Form Health Survey(SF-36), relapse rate, drug consolidation, medical-related expenses, income, drug plasma concentration and genetic information.","other_id":"SALT-C","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"Chinese Patients with Schizophrenia","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. An in-patient or out-patient (male or female) and aged 18 years\r\n\r\n          2. A diagnosis of schizophrenia,DSM-IV(Diagnostic and Statistical Manual Diploma in\r\n             Social Medicine-IV)\r\n\r\n          3. Subjects must have the ability to effectively communicate with investigator,complete\r\n             study related documents, comprehend the key components of the consent form and must\r\n             provide written informed consent to participate in the study prior to any study\r\n             specific assessments or procedures.\r\n\r\n          4. Patients are taking or will take atypical antipsychotics which include quetiapine,\r\n             olanzapine, risperidone, aripiprazole, ziprasidone, paliperidone , amisulpride ,\r\n             perospirone and clozapine\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Participation in other clinical studies.\r\n\r\n          2. Other conditions which, in the investigator's judgment, render patients unsuitable for\r\n             the clinical study.\r\n      ","sponsor":"Shanghai Mental Health Center","sponsor_type":"Other","conditions":"Schizophrenia","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Change from Baseline Systolic Blood Pressure","time_frame":"at 156 weeks","description":"Measure blood pressure at 156 weeks"},{"outcome_type":"primary","measure":"Change from Baseline liver function","time_frame":"at 156 weeks","description":"Measure blood biochemical tests at 156 weeks"},{"outcome_type":"primary","measure":"Change from Baseline PRL","time_frame":"at 156 weeks","description":"Measure PRL level at 156 weeks"},{"outcome_type":"primary","measure":"Change from Baseline thyroxine","time_frame":"at 156 weeks","description":"thyroxine laboratory tests at 156 weeks"},{"outcome_type":"primary","measure":"Number of Participants with EPS","time_frame":"at 156 weeks","description":"EPS assessment at 156 weeks"},{"outcome_type":"primary","measure":"Number of Participants with abnormal ECG","time_frame":"at 156 weeks","description":"ECG examination at 156 weeks"},{"outcome_type":"primary","measure":"Number of participants with abnormal sexual function","time_frame":"at 156 weeks","description":"sexual function evaluation medication at 156 weeks"},{"outcome_type":"secondary","measure":"Change from Baseline deduction of PANSS","time_frame":"at 156 weeks","description":"PANSS assessment at 156 weeks"},{"outcome_type":"secondary","measure":"Change from Baseline deduction of CGI-S","time_frame":"at 156 weeks","description":"CGI-S assessment at 156 weeks"},{"outcome_type":"secondary","measure":"Change from Baseline deduction of CDSS","time_frame":"at 156 weeks","description":"CDSS assessment at 156 weeks"},{"outcome_type":"secondary","measure":"Change from Baseline deduction of PSP","time_frame":"at 156 weeks","description":"PSP assessment at 156 weeks"}]}
{"nct_id":"NCT01256918","start_date":"2010-11-30","enrollment":200,"brief_title":"Study of Phacodepth Required for Safe and Effective Chop During Phacoemulsification for Cataract.","official_title":"Evaluation of Phacodepth Required to Achieve Full Thickness Nuclear Crack in Various Grades of Cataract and to Determine the Correlation Between the Two.","primary_completion_date":"2011-01-31","study_type":"Observational","rec_status":"Completed","completion_date":"2011-02-28","last_update":"2012-08-16","description":"There is a correlation between phacodepth required for full thickness nuclear crack and the various grades of cataract","other_id":"RMLH-001-EYE","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":40,"population":"The study will be conducted at EYE DEPARTMENT, Post Graduate Institute of Medical Education\r\n        and Research(PGIMER) , Dr R.M.L Hospital.\r\n\r\n        A consecutive sample of all eyes with cataract reporting to the eye OPD of Dr.\r\n        R.M.L.Hospital and fulfilling the inclusion criteria, would be enrolled in the study\r\n        starting a date following ethics committee approval till March 2011 ,after a written\r\n        informed consent.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients (> 40 years of age) with grade 3.0 to 6.9( according to LOCS-III) of senile\r\n             cataract will be included in this study\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Subluxated and dislocated lens.\r\n\r\n          2. Central leukomatous corneal opacity preventing visualization of cataractous lens for\r\n             grading and surgery.\r\n      ","sponsor":"Dr. Ram Manohar Lohia Hospital","sponsor_type":"Other","conditions":"Cataract","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Phacodepth Required to Achieve Full Thickness Nuclear Crack","time_frame":"day 0 of surgery","description":"phacodepth is the term used to describe the depth penetrated by the phacotip into the substance of lens.A note of depth penetrated by the tip to achieve full thickness nuclear crack shall be made."},{"outcome_type":"primary","measure":"Correlation Between Nuclear Colour and Phacodepth Required for a Safe and Effective Vertical Chop During Phacoemulsification","time_frame":"day 0 of surgery","description":"the nuclear colour grading as per LOCS III criteria for each case and the depth of penetration of phacotip required during a vertical chop was analysed to look for any correlation between the two."},{"outcome_type":"primary","measure":"Correlation Between Nuclear Opalescence and Phacodepth","time_frame":"day 0 of surgery","description":"Pearson correlation coefficient would be calculated to look for any correlation between\r\nnuclear opalescence as per LOCS III grading system for each cataract and\r\npenetration of phacotip required to achieve a full thickness nuclear crack in vertical chop during phacoemulsification of the cataractous lens"},{"outcome_type":"primary","measure":"Correlation Between Lens Thickness and Phacodepth","time_frame":"day 0 of surgery","description":"Pearson correlation coefficient would be calculated to look for any correlation between\r\nlength thickness measurement using A scan biometer for each cataract and\r\npenetration of phacotip required to achieve a full thickness nuclear crack in vertical chop during phacoemulsification of the cataractous lens"},{"outcome_type":"secondary","measure":"Posterior Capsular Rupture","time_frame":"day 0 of surgery.","description":"A note shall be made of any posterior capsular rupture attributable to the attempted vertical chop ."}]}
{"nct_id":"NCT02091947","start_date":"2010-11-30","phase":"Phase 2","enrollment":40,"brief_title":"Efficacy of Functional Magnetic Stimulation in Urinary Incontinence","official_title":"Efficacy of Functional Magnetic Stimulation in Urinary Incontinence","primary_completion_date":"2014-06-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2014-06-30","last_update":"2014-03-19","description":"Functional Magnetic Stimulation (FMS) appears to modulate autonomic and somatic nervous systems that innervate the lower urinary tract. Stimulation of the pudendal afferent nerve near the third sacral root induces relaxation of the detrusor muscles and reinforcement of urethral sphincter. Some preliminary studies had indicated the positive effect of FMS on stress urinary incontinence. Investigators aimed to evaluate the immediate and long-term effect of this method on stress urinary incontinent patients.","other_id":"201010015OB","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Urine incontinence refractory to traditional treatment\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Arrhythmia, pacemaker implantation\r\n      ","sponsor":"vghtpe user","sponsor_type":"Other","conditions":"Incontinence","interventions":[{"intervention_type":"Device","name":"Device: FMS (Magstim rapid2)","description":"5 Hz FMS, over bilateral sacral roots."}],"outcomes":[{"outcome_type":"primary","measure":"Symptom scoring on Urge-Urinary Distress Inventory questionnaire","time_frame":"up to 5 months"},{"outcome_type":"secondary","measure":"Cystometry and stress urethral pressure profile as measures of objective incontinence improvement","time_frame":"up to 5 months"}]}
{"nct_id":"NCT01309321","start_date":"2010-10-31","phase":"N/A","enrollment":400,"brief_title":"Perinatal Handwashing Intervention in Bangladesh","official_title":"Development and Evaluation of Perinatal Handwashing Promotion for Improved Maternal Handwashing Behavior","primary_completion_date":"2013-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-07-31","last_update":"2014-03-13","description":"The purpose of this study is to determine if an intensive handwashing intervention administered to primiparous women during their pregnancy can increase maternal handwashing with soap at critical times.","other_id":"PR-10036","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Primiparous women who plan to remain in the study area up to 1 months after birth\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior live birth\r\n      ","sponsor":"International Centre for Diarrhoeal Disease Research, Bangladesh","sponsor_type":"Other","conditions":"Sepsis|Umbilical Cord|Infection","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Perinatal Handwashing Promotion","description":"Pregnancy may serve as a unique opportunity to improve maternal handwashing behavior more deeply and sustainably than a handwashing promotion intervention at a different time. Primiparous women will receive an intensive handwashing promotion program delivered at 3 in-home visits between one month prenatal and 1 week post natal. The program will promote handwashing benefits, provide hardware to reduce barriers to handwashing, and educate mothers about the critical times for handwashing. Mothers will also receive an essential neonatal care package with information on clean delivery, hypothermia prevention, breastfeeding counseling, umbilical cord care, and identification of neonatal danger signs."},{"intervention_type":"Behavioral","name":"Behavioral: Neonatal Health Promotion","description":"Mothers will receive an essential neonatal care package with information on clean delivery, hypothermia prevention, breastfeeding counseling, umbilical cord care, and identification of neonatal danger signs."}],"outcomes":[{"outcome_type":"primary","measure":"Proportion of critical events where neonatal caregivers wash their hands with soap as a measure of behavior change.","time_frame":"1 month post-natal"},{"outcome_type":"primary","measure":"Proportion of critical events where neonatal caregivers wash their hands with soap as a measure of behavior change.","time_frame":"3 months post-natal"},{"outcome_type":"primary","measure":"Daily reduction in household soap weight.","time_frame":"2 weeks post-natal."},{"outcome_type":"primary","measure":"Daily reduction in household soap weight.","time_frame":"1 month post-natal"},{"outcome_type":"secondary","measure":"Incidence density of suspected sepsis in neonates","time_frame":"1 month post natal"},{"outcome_type":"secondary","measure":"Incidence density of suspected omphalitis in neonates","time_frame":"1 month post-natal"},{"outcome_type":"secondary","measure":"All cause neonatal mortality rate.","time_frame":"1 month post-natal."}]}
{"nct_id":"NCT02101957","start_date":"2010-10-31","phase":"Phase 2/Phase 3","enrollment":96,"brief_title":"Multicentric Trial of the Treatment of Huntington's Disease by Cysteamine (RP103)","primary_completion_date":"2015-07-31","study_type":"Interventional","rec_status":"Unknown status","last_update":"2014-04-02","description":"The purpose of this study is to evaluate the effect of cysteamine in patients with symptomatic Huntington's disease by comparing two groups of patients (cysteamine vs placebo) on the results of the Unified Huntington's Disease Rating Scale (UHDRS, Huntington study group 1996).","other_id":"PHRC2004-03bis","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Clinically disease-registered for at least one year, leading to consult (abnormal\r\n             movements, neuropsychiatric disorders, neuropsychological impairment).\r\n\r\n          -  Unified Huntington's Disease Rating Scale motor  5\r\n\r\n          -  Total Functional Capacity > 10 ( 11)\r\n\r\n          -  Huntington Disease diagnosed with abnormal number of CAG repeats: 38 < nucleotide\r\n             expansion (CAG)\r\n\r\n          -  Age between 18 and 65\r\n\r\n          -  Voluntarily Patient Consent\r\n\r\n          -  Patients willing and able to take oral medications, and comply with the specific\r\n             procedures of the study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Severe cognitive impairment or neuropsychiatric troubles.\r\n\r\n          -  No drug compliance to previous treatment.\r\n\r\n          -  Patients with contra indication to the realization of imaging studies (including\r\n             claustrophobia ) .\r\n\r\n          -  Patients who have not given their written and informed consent signed .\r\n\r\n          -  No national health insurance affiliation\r\n\r\n          -  Private patients of their liberty by judicial or administrative decision, or patients\r\n             under supervision.\r\n\r\n          -  Pregnant women ( pregnancy test will be carried out systematically for women at risk)\r\n             or lactating .\r\n\r\n          -  Women who could become pregnant during the study period and with no contraception.\r\n\r\n          -  Patients who have developed hypersensitivity to cysteamine or penicillamine ( against\r\n             indication of cysteamine ) .\r\n\r\n          -  Brain Damage intercurrent MRI. Brain morphological abnormalities , other than those\r\n             characteristic of the disease .\r\n\r\n          -  Disease - associated with neurological repercussions.\r\n\r\n          -  Affection - visceral serious , scalable , involving life-threatening.\r\n\r\n          -  Mental - disorder may disrupt accession to the Protocol , including a history of\r\n             spontaneous and / or drug-induced hallucinations history of severe depression that\r\n             required repeated hospitalizations , history of repeated suicide attempts .\r\n\r\n          -  Participation in progress, or interrupted for less than three months, a therapeutic\r\n             protocol of Huntington's disease .\r\n\r\n          -  Patients with a history of surgical interventions to improve the symptoms of\r\n             Huntington 's disease such as graft neuron, deep brain stimulation, infusion of\r\n             neurotrophic agent\r\n      ","sponsor":"University Hospital, Angers","sponsor_type":"Other","conditions":"Huntington's Disease","interventions":[{"intervention_type":"Drug","name":"Drug: RP103"},{"intervention_type":"Drug","name":"Drug: Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"Unified Huntington's Disease Rating Scale motor","time_frame":"at 18 months"}]}
{"nct_id":"NCT01230294","start_date":"2010-10-31","enrollment":150,"brief_title":"New Echocardiographic Methods for Right Ventricular Function.","official_title":"Evaluation of New Echocardiographic Methods for Measurement of Right Ventricular Function.","primary_completion_date":"2015-12-31","study_type":"Observational","rec_status":"Unknown status","last_update":"2016-11-08","description":"Aims of this study are the evaluation of new echocardiographic methods (3D/4D- and strain-echocardiography) for measurement of the right ventricular (RV) function .","other_id":"S275-2010","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"-  patients with pulmonary aterial hypertension\r\n\r\n          -  patients with chronic heart failure of the left ventricle affecting the right heart\r\n\r\n          -  patients without structural heart disease who underwent an echocardiographic\r\n             examination for other reasons (control group)","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  persons of 18 years and older who receive a transthoracic echocardiography at our\r\n             department\r\n\r\n          -  written consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  present atrial fibrillation/flutter\r\n\r\n          -  permanent pacemaker rhythm\r\n\r\n          -  moderate/severe valvular heart disease\r\n\r\n          -  pregnancy\r\n      ","sponsor":"Heidelberg University","sponsor_type":"Other","conditions":"Right Ventricular Dysfunction","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"3D-volumetry of the right ventricle","time_frame":"2 years"},{"outcome_type":"primary","measure":"2D strain of the right ventricle","time_frame":"2 years"},{"outcome_type":"secondary","measure":"pulmonary artery systolic pressure (PASP)","time_frame":"2 years","description":"standard value: ≤ 30 mmHg"},{"outcome_type":"secondary","measure":"tricuspid annular plane systolic excursion (TAPSE)","time_frame":"2 years","description":"standard value: ≥ 20 mm"},{"outcome_type":"secondary","measure":"tricuspid annular systolic velocity (TASV)","time_frame":"2 years","description":"standard value: ≥ 20cm/s"},{"outcome_type":"secondary","measure":"Tei-index (myocardial performance index)","time_frame":"2 years","description":"standard value: ≥ 0,5"},{"outcome_type":"secondary","measure":"LV-eccentricity-index (Lei-index)","time_frame":"2 years","description":"standard value: ≥ 1,0"}]}
{"nct_id":"NCT01068093","start_date":"2010-10-31","phase":"Phase 4","enrollment":120,"brief_title":"The Effects of Ezetimibe on Coronary Plaque Volume in Patients With Acute Coronary Syndrome","official_title":"Assessment of the Effects of Ezetimibe on Coronary Plaque Volume in Patients With Acute Coronary Syndrome","primary_completion_date":"2015-10-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2015-10-31","last_update":"2010-10-22","description":"The purpose of this study is to assess the effects of Ezetimibe on coronary plaque volume in patients with acute coronary syndrome.","other_id":"Y-ACS-E","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patients who have been diagnosed as acute coronary syndrome, and successful\r\n             percutaneous coronary intervention (PCI) were performed with intravascular ultrasound\r\n             (IVUS) guidance.\r\n\r\n          2. Patients having coronary plaques ( 500 m in thickness or % plaque of 20% or more at\r\n              5 mm distal or proximal to the previously treated area in the same branch of\r\n             coronary artery.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients with bypass graft or in-stent restenosis at the site of PCI.\r\n\r\n          2. Patients who received PCI in the past on the lesion where the evaluation of coronary\r\n             plaque volume is planned.\r\n\r\n          3. Patients who had plaques in a non-culprit site and might receive PCI during the\r\n             treatment period.\r\n\r\n          4. Patients receiving lipid-lowering drugs (statins, fibrates, probucol, nicotinic acid\r\n             or cholesterol absorption inhibitors).\r\n\r\n          5. Patients with familial hypercholesterolemia.\r\n\r\n          6. Patients with cardiogenic shock.\r\n\r\n          7. Patients receiving cyclosporine.\r\n\r\n          8. Patients with any allergy to Ezetimibe.\r\n\r\n          9. Patients with hepatobiliary disorders.\r\n\r\n         10. Pregnant women, women suspected of being pregnant, or lactating women.\r\n\r\n         11. Patients with renal disorders or undergoing dialysis.\r\n\r\n         12. Patients who are ineligible in the opinion of the investigator.\r\n      ","sponsor":"Yokohama City University Medical Center","sponsor_type":"Other","conditions":"Coronary Artery Disease","interventions":[{"intervention_type":"Drug","name":"Drug: Ezetimibe","description":"10mg daily"}],"outcomes":[{"outcome_type":"primary","measure":"the percent change in coronary plaque volume, the percent change in integrated backscatter signal obtained by integrated backscatter IVUS","time_frame":"9-11 months"},{"outcome_type":"secondary","measure":"absolute change from baseline in coronary plaque volume, absolute and percent changes in minimal lumen diameter and percent stenosis, absolute and percent changes in total cholesterol and low-density lipoprotein cholesterol","time_frame":"9-11 months"}]}
{"nct_id":"NCT01415856","start_date":"2010-10-31","phase":"Phase 2","enrollment":40,"brief_title":"Use of Pulsed Electromagnetic Fields for Postoperative Knee Pain","official_title":"A Randomized Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Non-Invasive Pulsed Electromagnetic Fields (PEMF) on Postoperative Pain Following Total Knee Arthroplasty","primary_completion_date":"2012-05-31","study_type":"Interventional","rec_status":"Unknown status","last_update":"2011-08-12","description":"The purpose of this study is to determine whether the Torino II device, which emits a pulsed electromagnetic field), will help to decrease pain and swelling after knee replacement surgery, and thereby decrease the use of narcotic medications after surgery.","other_id":"Salvagno 20100977","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age: greater than 18 years\r\n\r\n          -  Weight: less than 300 lbs.\r\n\r\n          -  Diagnosis: osteoarthritis\r\n\r\n          -  Type of Surgery: unilateral knee replacement\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  No pacemaker or defibrillator.\r\n\r\n          -  No infection of the affected knee.\r\n\r\n          -  No previous open surgery of the affected knee.\r\n\r\n          -  No history of Rheumatoid Arthritis.\r\n\r\n          -  No more than 2 narcotic pills per month in the last 6 months for pain.\r\n      ","sponsor":"Center for Joint Surgery and Sports Medicine, Maryland","sponsor_type":"Other","conditions":"Osteoarthritis","interventions":[{"intervention_type":"Device","name":"Device: Active Device (Torino II)","description":"Device is giving treatment for 15 minutes every 2 hours for a total of two weeks."},{"intervention_type":"Device","name":"Device: Sham Device (Torino II)","description":"Device is designed to appear to be giving treatment when it is not actually giving treatment. Patients will wear this for a duration of two weeks."}],"outcomes":[{"outcome_type":"secondary","measure":"Range of Motion","time_frame":"2 weeks","description":"Patient range of motion in degrees will be measured, for flexion and extension."},{"outcome_type":"primary","measure":"Pain","time_frame":"2 weeks","description":"Pain is measured on a scale of 0-10, which is the VAS scale used by most hospitals, including Meritus Medical Center. 0 indicates no pain, while 10 indicates the worst pain possible."},{"outcome_type":"primary","measure":"Edema (Swelling)","time_frame":"2 weeks","description":"Swelling will be measured by using a disposable tape measure to measure the circumference of the patient's knee at the mid-patellar region. This will be measured in millimeters."},{"outcome_type":"secondary","measure":"Narcotic Pain Medications","time_frame":"2 weeks","description":"Patients will record their use of pain and anti-inflammatory medications."}]}
{"nct_id":"NCT01221337","start_date":"2010-10-31","phase":"N/A","enrollment":32,"brief_title":"Heparin Free Haemodialysis With Haemodialyzers \"VIE\" Versus \"EVODIAL\"","official_title":"Comparative Study of Two Haemodialyzers \"VIE 2.1\" Versus \"EVODIAL2.2\" in a Strategy of Heparin-free Haemodialysis (HFH)","primary_completion_date":"2011-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-02-28","last_update":"2016-06-13","description":"The adequate anti coagulation is an absolute necessity in order to avoid the extra-corporal circuit and haemodialyzer clotting and to perform an adequate renal replacement therapy during a haemodialysis session. In the cases of multiple coagulation defects having high haemorrhagic risk factors and the patients under anti-coagulation therapy, it is recommended to reduce the heparin doses or to do heparin free haemodialysis. Several strategies of low heparin or heparin free haemodialysis have been proposed till now, without a real success. The heparin coated polyacrylonitrile haemodialyser (EVODIAL) has been reported to have 90 % successful heparin-free haemodialysis sessions. On the other hand, the vitamin E coated polysulphone (VIE) has also been reported to have an anti oxidative and anti-thrombotic properties and a capacity to improve the haemorrheological factors of human blood, hence having a promising future to perform a successful haemodialysis session with less or without heparin. This randomised, multi-centric, cross-over and open study has been designed to compare non inferiority of the haemodialyzer VIE 2,1 versus EVODIAL2,2 with a risk alfa of 5% and an absolute accepted difference of 12 %.","other_id":"10-PP-09","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        -- Adult chronic haemodialysis patients since al least 3 months\r\n\r\n          -  Two needles puncture of the fistula,\r\n\r\n          -  Low molecular weight heparinization during haemodialysis sessions,\r\n\r\n          -  Good fistula or central veinous catheter flow rate (blood pump flow rate  300\r\n             ml/min),\r\n\r\n          -  Systolic blood pressure  110 mmHg (mean value of three last dialysis sessions.\r\n\r\n          -  Patients capable to understand the design of the study and to follow the instructions\r\n\r\n          -  Patients having the French social security system affiliation.\r\n\r\n        Non-inclusion criteria :\r\n\r\n          -  C reactive protein > 30 mg/L.\r\n\r\n          -  Single needle puncture of the fistula\r\n\r\n          -  Active documented haemorrhage,\r\n\r\n          -  Haemoglobin < 10 g/dl and/or need blood transfusion,\r\n\r\n          -  Documented thrombophilia\r\n\r\n          -  Patients waiting for renal graft\r\n\r\n          -  Acute sepsis\r\n\r\n          -  Fistula or catheter dysfunction\r\n\r\n          -  Patients under anti-vitamine K\r\n\r\n          -  Per dialytic hypotension requiring al least once a nurse intervention,\r\n\r\n          -  Severe diseases (Dysglobulinemia, vascularitis, HIV),\r\n\r\n          -  Patients following another research protocol or have ended one less then one month\r\n             before starting of this study.\r\n\r\n          -  Pregnant or breast feeding patients,\r\n\r\n          -  Minor patients or under law-protection\r\n      ","sponsor":"Centre Hospitalier Universitaire de Nice","sponsor_type":"Other","conditions":"Adult Chronic Haemodialysis Patients Since at Least 3 Months","interventions":[{"intervention_type":"Other","name":"Other: heparin free haemodialysis","description":"Comparison of two haemodialyzers \"VIE 2,1\" versus \"EVODIAL 2,2\" in a strategy of heparin-free haemodialysis (HFH)."}],"outcomes":[{"outcome_type":"primary","measure":"The percentage of successful study periods with no circuit-clotting event leading to a premature interruption of any of the four dialysis sessions","time_frame":"during every haemodialysis sessions"},{"outcome_type":"secondary","measure":"Duration of dialysis session without blood circuit clotting","time_frame":"during every haemodialysis sessions"},{"outcome_type":"secondary","measure":"Number of times saline rinsing has been required","time_frame":"during every haemodialysis"},{"outcome_type":"secondary","measure":"Degree of blood clots in the venous bubble trap","time_frame":"during every haemodialysis sessions"},{"outcome_type":"secondary","measure":"Quality of blood restitution","time_frame":"during every haemodialysis sessions"},{"outcome_type":"secondary","measure":"Dialysis adequacy (KT/V)","time_frame":"during every haemodialysis sessions"},{"outcome_type":"secondary","measure":"Haematological status","time_frame":"during every haemodialysis sessions"},{"outcome_type":"secondary","measure":"tolerance","time_frame":"during every haemodialysis sessions"}]}
{"nct_id":"NCT01159730","start_date":"2010-10-31","phase":"Phase 2","enrollment":320,"brief_title":"Study to Assess the Safety and Efficacy of Multiple Doses of VB-201 on Biomarkers","official_title":"A Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Effect of Multiple Doses of VB-201 on Biomarkers","primary_completion_date":"2011-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-10-31","last_update":"2011-11-16","description":"The purpose of this study is to assess the safety and tolerability of multiple doses of VB-201 administered for 4 weeks and its efficacy on biomarkers.","other_id":"VB-201-030","allocation":"Randomized","intervention_model":"Parallel Assignment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female patients, 18 to 75 years of age;\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Presence of, or history of cancer, with the exception of completely excised,\r\n             non-metastatic squamous cell or basal cell carcinomas of the skin;\r\n\r\n          -  Has a clinically significant systemic infection (e.g., chronic or acute infection,\r\n             UTI, URI) within 30 days of Day 0, or a history or presence of recurrent or chronic\r\n             infection (e.g. viral infections, [including hepatitis B or C, HIV], bacterial\r\n             infections, systemic fungal infections, or syphilis);\r\n\r\n          -  Subjects with a history of coronary events within the last 6 months;\r\n      ","sponsor":"Vascular Biogenics Ltd. operating as VBL Therapeutics","sponsor_type":"Industry","conditions":"Biomarker","interventions":[{"intervention_type":"Drug","name":"Drug: VB-201 or Placebo"}],"outcomes":{}}
{"nct_id":"NCT01604733","start_date":"2010-10-31","enrollment":1000,"brief_title":"Centralized Pan-Middle East Survey on the Undertreatment of Hypercholesterolemia","official_title":"Centralized Pan-Middle East Survey on the Undertreatment of Hypercholesterolemia","primary_completion_date":"2011-06-30","study_type":"Observational","rec_status":"Completed","completion_date":"2011-06-30","last_update":"2012-05-24","description":"Study objective is to evaluate the level of control of hypercholesterolemia in Egypt in patients taking lipid lowering agents for at least 3 months ( with no drug change or dose amendment for a minimum of 6 weeks).","other_id":"NIS-EG-CRE-2010/01","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Community patients","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18 years and above on current lipid lowering drug for at least 3 months with no dose\r\n             change for a minimum of 6 weeks\r\n\r\n          -  Subject must provide informed consent and comply with the survey procedures\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Less than 18 years less than 3 months on antidyslipidemic agent Subjects who are\r\n             unwilling or unable to provide informed consent\r\n      ","sponsor":"AstraZeneca","sponsor_type":"Industry","conditions":"Hypercholesterolemia","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"The proportion of patients on lipid-lowering treatment reaching the LDL-C goals according to the NCEP ATP III/ updated 2004 NCEP ATP III , overall and by country","time_frame":"24 weeks"},{"outcome_type":"secondary","measure":"The proportion of patients on lipid-lowering treatment reaching the LDL-C goals according to the NCEP ATP III/ updated 2004 NCEP ATP III , in the following sub-populations: - primary/secondary prevention patients and with metabolic syndromes","time_frame":"24 weeks"},{"outcome_type":"secondary","measure":"The proportion of patients on lipid-lowering treatment reaching the LDL-C goals according to the Third Joint European Task Force guideline, in the following sub-populations: - primary/secondary prevention patients and with metabolic syndromes","time_frame":"24 weeks"},{"outcome_type":"secondary","measure":"Determinants (e.g. patient and physician characteristics , country-specific guidelines or recommendations) for undertreatment of hypercholesterolemia","time_frame":"24 weeks"},{"outcome_type":"secondary","measure":"Physician characteristics associated with the allocation of treatment regimen.","time_frame":"24 weeks"},{"outcome_type":"secondary","measure":"The proportion of patients on lipid-lowering treatment reaching the non HDL-C goals according to the NCEP ATP III/ updated 2004 NCEP ATP III , in the sub-population patients with fasting triglycerides<200 mg/d","time_frame":"24 weeks"}]}
{"nct_id":"NCT01199289","start_date":"2010-10-31","phase":"Phase 2","enrollment":315,"brief_title":"A Study to Evaluate the Dosing of AMG 827 for Subjects With Inadequately Controlled Asthma","official_title":"A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Determine the Safety and Efficacy of AMG 827 in Subjects With Inadequately Controlled Asthma","primary_completion_date":"2011-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-12-31","last_update":"2015-05-15","description":"The purpose of this study is to determine if AMG 827 is effective compared to placebo as measured by change in Asthma Control Questionnaire (ACQ) composite scores.","other_id":"20090203","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Men or women 18 to 65 years of age\r\n\r\n          -  Percent of predicted FEV1  50% and  80%\r\n\r\n          -  At least 12% reversibility over pre-bronchodilator FEV1\r\n\r\n          -  Inhaled corticosteroid (ICS)  200 and  1000 g/day fluticasone or equivalent.\r\n\r\n          -  Ongoing asthma symptoms with ACQ composite score  1.5 points\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Respiratory infection within 4 weeks of screening visit or 1 week of baseline visit\r\n\r\n          -  History of chronic obstructive pulmonary disease or other chronic pulmonary condition\r\n             other than asthma\r\n\r\n          -  Any uncontrolled or clinically significant systemic disease (eg, uncontrolled\r\n             diabetes, liver disease)\r\n      ","sponsor":"Amgen","sponsor_type":"Industry","conditions":"Asthma","interventions":[{"intervention_type":"Drug","name":"Drug: AMG 827","description":"210 mg AMG 827 SC"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo SC"},{"intervention_type":"Drug","name":"Drug: AMG 827","description":"140 mg AMG 827 SC"},{"intervention_type":"Drug","name":"Drug: AMG 827","description":"280 mg AMG 827 SC"}],"outcomes":[{"outcome_type":"primary","measure":"The primary objective is to determine if AMG 827 is effective compared to placebo as mesasured by change in Asthma Control Questionnaire (ACQ) composite scores from baseline to week 12.","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"Evaluate the efficacy of AMG 827 as measured by Pre- and post-bronchodilator FEV1 (forced expiratory volume in 1 second)","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"Evaluate the efficacy of AMG 827 as measured by am and pm Peak expiratory flow rate (PEFR)","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"Evaluate the efficacy of AMG 827 as measured by use of rescue Short Acting β-Agonist (SABA) use","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"Evaluate the efficacy of AMG 827 as measured by daily asthma symptoms (aggregate/night and individual)","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"Evaluate the efficacy of AMG 827 as measured by Asthma Quality of Life Questionnaire (AQLQ) score","time_frame":"12 weeks"}]}
{"nct_id":"NCT01240369","start_date":"2010-10-31","enrollment":250,"brief_title":"Association Between VEGF-C and miRNA and Clinical Non-small Cell Lung Cancer and Esophagus Squamous Cell Carcinoma","study_type":"Observational","rec_status":"Unknown status","last_update":"2010-11-15","description":"Lung cancer and esophageal cancer remain the leading causes of cancer death worldwide. The main problem is lack of effective tool in early detection that accounts for the poor outcome of cancer. Clinically, over 80% of patients with cancer were at late stage when they were diagnosed. Therefore, it is important for us to find the biomarker that serve as the early prediction of cancer. The investigators have published that VEGFC over-expressed in non-small cell lung cancer. VEGFC plays a critical role in regulating motility of tumor cells, promotes proliferation of lymphatic endothelial cells and enhances migration and invasion. Investigator found that VEGFC over-expressed in the serum of esophageal cancer patients. Therefore, it is worthwhile to investigate the correlation between VEGFC, clinical lung cancer and esophageal cancer. MicroRNAs (miRNAs) are conserved, endogenous, small, and noncoding RNA molecules of 21~23 nucleotides that function as post-transcriptional gene regulators. Recent studies indicated that certain microRNAs reduced in cancer patients. Therefore it is important to investigate whether specific microRNA changed in certain kinds of cancer patients.","other_id":"DMR99-IRB-206","observational_model":"Case-Only","time_perspective":"Cross-Sectional","sampling_method":"Probability Sample","gender":"All","minimum_age":50,"maximum_age":80,"population":"ESCC and NSCLC patients","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  tumor size > 0.5 cm3\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  tumor size < 0.5 cm3\r\n      ","sponsor":"China Medical University Hospital","sponsor_type":"Other","conditions":"VEGFC Protein in Serum|VEGFC Protein in Non Small Cell Lung Cancer|VEGFC Protein in ESCC|CTTN Protein in ESCC|miR326 in ESCC and Non Small Cell Lung Cancer","interventions":{},"outcomes":{}}
{"nct_id":"NCT01320176","start_date":"2010-10-31","phase":"Phase 1","enrollment":36,"brief_title":"Study to Evaluate the Dosage and Safety of Two Intramuscular Injections of an Investigational Clade B HIV Vaccine","official_title":"An Open-label, Phase I, Dose-escalation and Safety Study of Two Intramuscular Injections of a Dose of 2.9 Log or 4 Log CCID50 of the Recombinant HIV I Clade B Measles Vaccine Vector in Healthy Adults.","primary_completion_date":"2011-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-11-30","last_update":"2012-02-14","description":"This study aimed to evaluate the safety and reactogenicity of two intramuscular injections of two different dosages of an investigational clade B HIV vaccine.","other_id":"MV1-F4-CT1","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":27,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Subjects who the investigator believes can and will comply with the requirements of\r\n             the protocol (e.g. completion of the diary cards, return for follow-up visits) and are\r\n             available for all scheduled visits at the investigational site\r\n\r\n          2. Adult male and or female subjects between 18 and 27 years old.\r\n\r\n          3. Proven record of measles vaccination (longer than 5 years)\r\n\r\n          4. Measles antibodies titre < 350 IU/L or > 750 IU/L measured in the previous study\r\n             \"CEVAC sero-MV-001\".\r\n\r\n          5. Healthy subjects as established by medical history and clinical examination before\r\n             entering into the study.\r\n\r\n          6. Confirmed HIV negative based on the absence of antibodies and p24.\r\n\r\n          7. Negative for Hepatitis B surface (HBs) antigen, anti-hepatitis B core (HBc antibodies)\r\n             antibody and anti-Hepatitis C Virus (HCV) antibody\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Participation in another clinical study in the last 6 months in which the subject has\r\n             been exposed to an investigational product (pharmaceutical product or placebo or\r\n             device) or concurrent participation in another clinical study during the study period.\r\n\r\n          2. Previous inclusion in an HIV vaccine study.\r\n\r\n          3. Receipt of any other vaccination 1 month before or planning to receive any vaccination\r\n             1 month after each study vaccination\r\n\r\n          4. Receipt of tuberculin skin test 1 month before or planning to receive a tuberculin\r\n             test 1 month after each study vaccination\r\n\r\n          5. Receipt of allergy treatment with antigen injections 1 month before or planning to\r\n             receive allergy treatment with antigen injections 1 month after each study vaccination\r\n\r\n          6. Receipt of blood products or immunoglobulins within 120 days prior to enrolment.\r\n\r\n          7. Measles vaccination or booster within the last 5 years as confirmed by medical\r\n             history.\r\n\r\n          8. Subject is pregnant or breastfeeding or intends to become pregnant within 9 months of\r\n             enrolling into the study.\r\n\r\n          9. Subject is of childbearing potential and does not agree to use a medically acceptable\r\n             form of contraception for the duration of the study (9 months post the first\r\n             investigational HIV vaccination). Medically acceptable forms of contraception include:\r\n             Contraceptive Medication, Intrauterine device, Double barrier method (Condom* and\r\n             Occlusive cap (diaphragm or cervical/vault caps) with spermicidal\r\n             foam/gel/film/cream/suppository.\r\n\r\n             * A female condom and a male condom should not be used together as friction between\r\n             the two can result in either product failing.\r\n\r\n         10. History of any significant immunodeficient condition.\r\n\r\n         11. Chronic administration (defined as more than 14 days) of immunosuppressants or other\r\n             immune-modifying drugs within the 6 months prior to the first vaccination\r\n\r\n         12. Individuals who are at high risk of acquired HIV infection as determined by the risk\r\n             assessment questionnaire.\r\n\r\n         13. Individuals who are living and/or working with severely immunocompromised people,\r\n             children under 15 months old or pregnant women.\r\n\r\n         14. Family history of immunodeficiency and/or personal history of autoimmune disease\r\n             (including psoriasis, rheumatoid arthritis, autoimmune thyroid disease).\r\n\r\n         15. History of type I or type II diabetes mellitus including cases controlled with diet\r\n             alone.\r\n\r\n         16. History or ongoing malignancy.\r\n\r\n         17. Major congenital defects or serious chronic illness at the time of enrolment.\r\n\r\n         18. History of serious adverse reactions to vaccine administration, including anaphylaxis\r\n             and related symptoms, such as urticaria, respiratory difficulty, angioedema and\r\n             abdominal pain to vaccines, or history of allergic reaction likely to be exacerbated\r\n             by any component of the vaccine.\r\n\r\n         19. Acute or chronic, clinically significant, as determined by the investigator,\r\n             pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by\r\n             physical examination or laboratory screening tests.\r\n\r\n         20. Individuals whose Body Mass index (BMI) is less than 18.5 or greater than 30 (i.e.\r\n             underweight or obese).\r\n\r\n         21. History of clinically significant, as determined by the investigator, neurological\r\n             disorder or seizures.\r\n      ","sponsor":"Institut Pasteur","sponsor_type":"Industry","conditions":"HIV","interventions":[{"intervention_type":"Biological","name":"Biological: Investigational HIV vaccine dose A","description":"The vaccine will be administered by intramuscular route into the deltoid muscle preferentially of the non dominant arm at Month 0 and Month 3"},{"intervention_type":"Biological","name":"Biological: Investigational HIV vaccine dose B","description":"The vaccine will be administered by intramuscular route into the deltoid muscle preferentially of the non dominant arm at Month 0 and Month 3"}],"outcomes":[{"outcome_type":"primary","measure":"Occurrence and relationship to vaccination of any serious AEs (SAEs)","time_frame":"During the study period (Month 0-11)"},{"outcome_type":"primary","measure":"Occurrence, intensity and relationship to vaccination of solicited local and general adverse events (AEs) except fever","time_frame":"14-day follow-up after each vaccination"},{"outcome_type":"primary","measure":"Occurrence, intensity and relationship to vaccination of fever","time_frame":"21-day follow-up after each vaccination"},{"outcome_type":"primary","measure":"Occurrence, intensity and relationship to vaccination of unsolicited adverse events (AEs)","time_frame":"42-day follow-up after each vaccination"},{"outcome_type":"primary","measure":"Occurrence, intensity and relationship to vaccination of clinically significant abnormal haematology and biochemistry values (grade 3 or 4)","time_frame":"During the study period (Month 0-11)"},{"outcome_type":"secondary","measure":"Occurrence of shedding of recombinant virus","time_frame":"During the study period (Month 0-11)"},{"outcome_type":"secondary","measure":"Recombinant virus infectivity","time_frame":"During the study period (Month 0-11)"},{"outcome_type":"secondary","measure":"Cell-mediated immune response (CMI)","time_frame":"At day 0, 7, 14, 28, 91, 98, 112, 266"},{"outcome_type":"secondary","measure":"Humoral immune response to HIV antigens","time_frame":"At day 14, 28, 84, 98, 112, 266."}]}
{"nct_id":"NCT01566305","start_date":"2010-10-31","phase":"N/A","enrollment":108,"brief_title":"Effects of Buttermilk on Serum LDL Cholesterol Concentrations","official_title":"The Effects of Buttermilk With or Without Lutein-enriched Egg Yolk on the Serum LDL Cholesterol Concentration of Slightly Hypercholesterolaemic Volunteers","primary_completion_date":"2012-05-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-12-01","last_update":"2018-09-06","description":"Rationale and objective: Based on the results of a pilot study, the objective of the present study is to evaluate whether buttermilk lower serum LDL cholesterol concentrations and can prevent the serum LDL cholesterol raising effects of eggs. Study Design: The study has a randomized placebo-controlled factorial 2x2 design. The total study duration is 14 weeks, consisting of a 2 weeks run-in period and a 12 weeks experimental period. Subjects will be stratified for age, gender and BMI over the experimental groups. Study population: One hundred and eight healthy male and female subjects, aged 18-70 years, with slightly elevated serum total cholesterol concentrations (5.5-8.0 mmol/l). Intervention: During the entire study period, volunteers are instructed to consume a diet according to the Dutch dietary guidelines (35 en% fat (10 en% saturated fat), 50-55 en% carbohydrates). During the two weeks run-in period all subjects will drink daily at lunch 100 mL skimmed milk. During the 12 weeks experimental period, a first group of subjects will continue drinking the skimmed milk (control group), while a second group will consume a low-fat buttermilk, a third group skimmed milk enriched with egg-yolk, and a fourth group egg-yolk incorporated into a low-fat buttermilk based beverage. The egg-yolk will be enriched in lutein. Whole egg consumption (others than provided by us) is not allowed during the entire study. Main study parameters/endpoints: Measurements will be performed during the run-in period (days 0, 11 and 14) and during the experimental period (days 56, 95 and 98). The main effects (egg-yolk and buttermilk consumption) will be calculated as the absolute differences between values obtained at the end of the experimental (average days 95 and 98) and run-in (average days 11 and 14) periods. The primary endpoint is the change in serum LDL cholesterol concentrations. Secondary endpoints are changes in serum total and HDL cholesterol, triacylglycerol, apoA-I, apoB and hsCRP concentrations.","other_id":"NL33461.068.10","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Aged between 18 and 70 years\r\n\r\n          -  Fasting serum total cholesterol between 5.5 - 8.0 mmol/l\r\n\r\n          -  Fasting plasma glucose < 7.0 mmol/l\r\n\r\n          -  BMI between 25-30 kg/m2\r\n\r\n          -  non-smoking\r\n\r\n          -  Willingness to abstain for the duration of the study from egg consumption\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  unstable body weight (weight gain or loss >3 kg in the past 3 months)\r\n\r\n          -  allergic for eggs or egg-rich products\r\n\r\n          -  allergic or intolerant for cow-milk (lactose) based products\r\n\r\n          -  indication for treatment with cholesterol-lowering drugs according to the Dutch\r\n             Cholesterol Consensus\r\n\r\n          -  use of medication or a diet known to affect serum lipid or glucose metabolism - active\r\n             cardiovascular disease (for instance congestive heart failure) or recent (<6 months)\r\n             event, such as acute myocardial infarction or cerebro-vascular accident\r\n\r\n          -  not willing to stop the consumption of vitamin supplements, fish oil capsules or\r\n             products rich in plant stanol or sterol esters 3 weeks before the start of the study\r\n\r\n          -  men: consumption of >21 alcohol consumptions a week\r\n\r\n          -  women: consumption of >14 alcohol consumptions a week\r\n\r\n          -  abuse of drugs\r\n\r\n          -  pregnant or breastfeeding women\r\n\r\n          -  participation in another biomedical study within 1 month prior to the screening visit\r\n\r\n          -  having donated blood (as blood donor) within 1 month prior to the screening visit or\r\n             planning to do so during the study\r\n\r\n          -  impossible or difficult venipuncture as evidenced during the screening visits\r\n      ","sponsor":"Maastricht University Medical Center","sponsor_type":"Other","conditions":"Hypercholesterolemia|Buttermilk|Dietary Modification|Cardiovascular Disease","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Buttermilk without added egg-yolk","description":"Buttermilk without added egg-yolk"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Buttermilk with added egg yolk","description":"Buttermilk with added egg yolk"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Skimmed milk with added egg-yolk","description":"Skimmed milk with added egg-yolk"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Skimmed milk without added egg yolk","description":"Skimmed milk without added egg yolk"}],"outcomes":[{"outcome_type":"primary","measure":"Change in serum LDL cholesterol concentrations","time_frame":"LDL cholesterol will be measured at day 0, 11, 14, 56, 95 and 98 during the study"},{"outcome_type":"secondary","measure":"Changes in serum total and HDL cholesterol, triacylglycerol, apoA-I, apoB and hsCRP concentrations","time_frame":"Serum total and HDL cholesterol, triacylglycerol, apoA-I and ApoB will be measured at day 0, 11, 14, 56, 95 and 98 during the study. hsCRP concentrations will be measured at day 11, 14, 95 and 98."}]}
{"nct_id":"NCT01217983","start_date":"2010-10-31","enrollment":105,"brief_title":"Utility of Renal Biomarkers in Cirrhosis","official_title":"Utility of Renal Biomarkers in Cirrhotic Patients","primary_completion_date":"2012-10-31","study_type":"Observational","rec_status":"Completed","completion_date":"2012-10-31","last_update":"2012-10-30","description":"Evaluation of kidney function is critical in cirrhotic patients as there is a clear relationship between renal failure and prognosis. The investigators hypothesized that in this population new biomarkers of renal function could help in early detection of acute renal failure and in discrimination between renal and pre-renal causes. Finally the investigators hypothesized that such biomarkers could predict short-term outcome in this population.","other_id":"10-056 Med 10-019","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"All patients admitted for cirrhotic ascitis in the University Hospital of Geneva.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age  18 years\r\n\r\n          -  Known or suspected cirrhosis\r\n\r\n          -  Suspected ascitis\r\n\r\n          -  Informed consent signed\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Proven multifocal hepatocellular carcinoma\r\n\r\n          -  Acute gastric hemorrhage (active or < 2 weeks)\r\n\r\n          -  Known end-stage renal disease or on dialysis before admission\r\n\r\n          -  Recipients of kidney or liver transplants\r\n\r\n          -  Transferred from another institution\r\n      ","sponsor":"University Hospital, Geneva","sponsor_type":"Other","conditions":"Cirrhosis|Ascitis","interventions":{},"outcomes":[{"outcome_type":"secondary","measure":"Prediction of AKI developement using renal artery resistive indexes.","time_frame":"30 days"},{"outcome_type":"primary","measure":"Early detection of acute kidney injury in hospitalized cirrhotic patients with ascitis using new renal biomarkers","time_frame":"30 days","description":"Acute kidney injury will be defined using RIFLE and AKIN criteria."},{"outcome_type":"secondary","measure":"Prediction of adverse clinical outcomes (Renal replacement therapy, transfer to ICU, all cause mortality).","time_frame":"30 days"},{"outcome_type":"secondary","measure":"Discrimination between different type of AKI.","time_frame":"30 days"}]}
{"nct_id":"NCT01222559","start_date":"2010-10-31","phase":"Phase 3","enrollment":102,"brief_title":"Efficacy and Safety Study of co.Don Chondrosphere to Treat Cartilage Defects","official_title":"Prospective, Randomised, Open Label, Multicentre Phase-III Clinical Trial to Compare the Efficacy and Safety of the Treatment With the Autologous Chondrocyte Transplantation Product co.Don Chondrosphere (ACT3D-CS) With Microfracture in Subjects With Cartilage Defects of the Knee With a Defect Size Between 1 an 4 cm2","primary_completion_date":"2017-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-02-29","last_update":"2021-01-27","description":"This is a prospective, phase III, multicenter, open label, randomised clinical trial of co.don chondrosphere, a three-dimensional autologous chondrocyte transplantation product (ACT3D-CS)compared to the procedure of microfracture (MF)in the treatment of cartilage defects of knee joints. After screening visit patients were booked for arthroscopy and at that time they were randomised to either ACT3D-CS with co.don chondrosphere (Group A) or to MF(Group B), a marrow-stimulating method based on the penetration of the subchondral bone plate at the bottom of the cartilage defect. At the time of arthroscopy Patients of group B had their procedure of MF (treatment surgery) and patients of group A had their cells harvested from healthy cartilage. The cells are cultivated for 8-10 weeks in vitro to develope 3-dimensional spheroids , that are transplanted in an open knee procedure (treatment surgery)into the defect. Patients subsequently followed the same rehabilitation program and had post-surgery visits. After the 12-month-visit a interim analyses will be performed and the 24-month-visit is defined as final assessment. Then patients have follow-up assessments up to 60 months post-treatment-surgery.","other_id":"cod16HS13","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Male or female patients, age: between 18 and 50 years\r\n\r\n          2. Defect: isolated ICRS grade III or IV single defect chondral lesions on femoral\r\n             condyles\r\n\r\n          3. Defect size: 1 to < 4 cm2 after debridement to healthy cartilage up to 6 mm in\r\n             depth.Assessment with MRI at screening and per estimation during arthroscopy prior to\r\n             randomization\r\n\r\n          4. Nearly intact chondral structure surrounding the defect as well as an intact\r\n             corresponding joint area\r\n\r\n          5. Informed consent signed and dated by patient\r\n\r\n          6. Patient understands the strict rehabilitation protocol and follow-up programme and is\r\n             willing to follow it\r\n\r\n          7. In case of pain, patient agrees to use only paracetamol mono- (max 4 g/day) or\r\n             combination preparation and oral and/or topic NSAIDs during the trial and to\r\n             discontinue the use of oral and/or topic NSAIDs and/or paracetamol combination\r\n             preparation 1 week before each visit whereas the use of paracetamol monopreparation\r\n             (max 4 g/day) is allowed. However, in the morning of the visit day, no pain medication\r\n             is allowed. Other pain medications are allowed during surgical procedure and may be\r\n             taken for a period not exceeding 4 weeks after surgery.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Defects on both knees at the same time\r\n\r\n          2. Radiological signs of osteoarthritis\r\n\r\n          3. Osteochondritis dissecans (OCD)\r\n\r\n          4. Any signs of knee instability\r\n\r\n          5. Valgus or varus malalignment (more than 5 over the mechanical axis)\r\n\r\n          6. Clinically relevant second cartilage lesion on the same knee\r\n\r\n          7. More than 50 % resection of a meniscus in the affected knee or incomplete meniscal rim\r\n\r\n          8. Rheumatoid arthritis, parainfectious or infectious arthritis, and condition after\r\n             these diseases\r\n\r\n          9. Pregnancy and planned pregnancy (no MRI possible)\r\n\r\n         10. Obesity (Body Mass Index >30)\r\n\r\n         11. Uncontrolled diabetes mellitus\r\n\r\n         12. Serious illness\r\n\r\n         13. Poor general health as judged by physician\r\n\r\n         14. Participation in concurrent clinical trials or previous trials within 3 months of\r\n             screening\r\n\r\n         15. Previous treatment with ACT in the affected knee\r\n\r\n         16. Microfracture performed less than 1 year before screening in the affected knee\r\n\r\n         17. Alcohol or drug (medication) abuse\r\n\r\n         18. Meniscal transplant in the affected knee\r\n\r\n         19. Meniscal suture (in the affected knee) three months prior to baseline\r\n\r\n         20. Mosaicplasty (Osteoarticular Transplant System, OATS) in the affected knee\r\n\r\n         21. Having received hyaluronic acid intra-articular injections in the affected knee within\r\n             the last 3 months before baseline\r\n\r\n         22. Taking specific osteoarthritis drugs such as chondrotin sulfate, diacerein,\r\n             nglucosamine,piascledine, capsaicin within 2 weeks before baseline\r\n\r\n         23. Corticosteroid treatment by systemic or intraarticular route within the last month of\r\n             baseline or intramuscular or oral corticosterods within the last 2 weeks before\r\n             baseline\r\n\r\n         24. Chronic use of anticoagulants\r\n\r\n         25. Any concomitant painful or disabling disease of the spine, hips or lower limbs that\r\n             would interfere with evaluation of the afflicted knee\r\n\r\n         26. Any clinically significant or symptomatic vascular or neurological disorder of the\r\n             lower extremities\r\n\r\n         27. Any evidence of the following diseases in the affected knee: septic arthritis,\r\n             inflammatory joint disease, recurrent episodes of pseudogout, Paget's disease of bone,\r\n             ochronosis, acromegaly, haemochromatosis, Wilson's disease, primary\r\n             osteochondromatosis, heritable disorders, collagen gene mutation\r\n\r\n         28. Current diagnosis of osteomyelitis, human immunodeficiency virus (HIV-1,-2) and/or\r\n             hepatitis C virus (HCV) infection\r\n      ","sponsor":"co.don AG","sponsor_type":"Industry","conditions":"Articular Cartilage Lesion of the Femoral Condyle","interventions":[{"intervention_type":"Drug","name":"Drug: co.don chondrosphere","description":"co.don chondrosphere are spheroids in suspension, developed from autologous chondrocytes. The dose depends on the size of the defect, recommended dose is 10-70 spheroids/cm2 defect."},{"intervention_type":"Procedure","name":"Procedure: Microfracture","description":"A procedure in which the subchondral bone is perforated to allow a bloodcloth to form new tissue."}],"outcomes":[{"outcome_type":"primary","measure":"Change of overall KOOS","time_frame":"24 months after the end of the respective treatment","description":"Change of overall KOOS (Knee Injury and Osteoarthritis Outcome Score)from baseline (Day 0)to final assessment compared between ACT3D-CS (co.don chondrosphere) and MF (microfracture)"},{"outcome_type":"secondary","measure":"Change of overall KOOS","time_frame":"12, 36, 48, 60 months after the end of the respective treatment","description":"Change of overall KOOS(Knee Injury and Osteoarthritis Outcome Score) from baseline (Day 0) to 12 months, 36, 48, 60 months after the end of the respective treatment,compared between ACT3D-CS and MF"},{"outcome_type":"secondary","measure":"Change of the 5 subscores of the KOOS","time_frame":"12, 24, 36, 48, 60 months after the end of the respective treatment","description":"Change of the 5 subscores of the KOOS (Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec), knee related Quality of life (QoL)) for both treatment groups compared between ACT3D-CS and MF"},{"outcome_type":"secondary","measure":"MOCART (MRI Score)","time_frame":"12, 24, 36, 48 and 60 months after transplantation or microfracture","description":"MOCART (MRI Score) 12, 24, 36, 48 and 60 months after transplantation or microfracture compared between ACT3D-CS and MF"},{"outcome_type":"secondary","measure":"Arthroscopy and biopsy","time_frame":"24 months","description":"Arthroscopy and biopsy at 24 months after transplantation/ microfracture, assessment of cartilage repair after ACT3D and microfracture to be compared between ACT3D-CS and MF"},{"outcome_type":"secondary","measure":"ICRS Visual Histological Assessment Score","time_frame":"24 months after respective treatment","description":"ICRS Visual Histological Assessment Score at final assessment (24 months) compared between ACT3D-CS and MF"},{"outcome_type":"secondary","measure":"Bern Score and additional histological assessment scores","time_frame":"24 months after the respective treatment","description":"Bern Score and additional histological assessment scores at final assessment (24 months) compared between ACT3D-CS and MF"},{"outcome_type":"secondary","measure":"Change of ICRS/IKDC","time_frame":"12, 24, 36, 48 and 60 months after the end of the respective treatment","description":"Change of ICRS/IKDC from baseline (Day 0) to 12, 24, 36, 48 and 60 months after the end of the respective treatment, compared between ACT3D-CS and MF"},{"outcome_type":"secondary","measure":"Change of modified Lysholm Score","time_frame":"12, 24, 36, 48 and 60 months after the end of the respective treatment","description":"Change of modified Lysholm Score from baseline (Day 0) to 12, 24, 36, 48 and 60 months after the end of the respective treatment compared between ACT3D-CS and MF"},{"outcome_type":"secondary","measure":"Days of absence from work (employment) and/or days of inability to follow usual activities","time_frame":"annual","description":"Days of absence from work (employment) and/or days of inability to follow usual activities during the last year or since the last visit, respectively, and time point when patient was back to work and/or to follow usual activities"},{"outcome_type":"secondary","measure":"Safety Parameters","time_frame":"3,12,24 months after respective treatment","description":"Frequence and type of adverse Events Vital signs Physical examination Concomitant pain medication Laboratory parameters"}]}
{"nct_id":"NCT02382159","start_date":"2010-10-31","enrollment":1000,"brief_title":"A Observational Study to Evaluate Lipid-lowering Drug Its Effect on Parameters in Dyslipidemia of Type 2 Diabetes.","official_title":"Observational, Retrospective, Multi-center Study for Therapeutic Practice Pattern of Lipid-lowering Drug and Its Effect on Parameters in Dyslipidemia of Type 2 Diabetes.","primary_completion_date":"2015-04-30","study_type":"Observational","rec_status":"Completed","completion_date":"2015-06-30","last_update":"2015-07-17","description":"1. Target disease: Patients with combined dyslipidemia accompanied by type 2 diabetes who has done exogenous visit or hospitalization from Jan 2010 to June 2014. 2. Study objective: 1. The objective of this study is to Identifying the lipid parameter variation when treating patients who have dyslipidemia of type 2 diabetes for 31 months. 2. After treating patients who have dyslipidemia of type 2 diabetes for 31 months, identifying the reason why changing method of drug dosage and pharmacotherapy. 3. If the drug dosage and pharmacotherapy have been changed, Identifying the lipid parameter variation when treating patients by altered drugs for 31 months,","other_id":"YYP-OS-001","observational_model":"Case-Control","time_perspective":"Retrospective","sampling_method":"Probability Sample","gender":"All","minimum_age":20,"maximum_age":75,"population":"1. Base-line (The starting time of treating lipid-lowering drug within 3 months period of\r\n             2010 ~ 2013 years)\r\n\r\n               -  Background of Patients: Basic information(Height, Weight), Smoking, Drinking and\r\n                  other related illness.\r\n\r\n               -  Hypoglucemic agent, Diabetes test(Fasting blood glucose, GL test, Glycated\r\n                  Hemoglobin)\r\n\r\n               -  At the time of Starting the treating lipid-lowering drug, total Cholesterol, TG,\r\n                  LDL-C, HDL-C checked before treating lipid-lowering drug.\r\n\r\n          2. After 31 months from base-line\r\n\r\n               -  Hypoglycemic agent, Diabetes test\r\n\r\n               -  Total Cholesterol, TG, LDL-C at the point of 31 months from treating changed\r\n                  lipid-lowering drug, and the reason of drug dosage and pharmacotherapy\r\n\r\n          3. After 31 months from treating by changed lipid-lowering drug\r\n\r\n               -  Hypoglycemic agent, Diabetes test\r\n\r\n               -  Total Cholesterol, TG, LDL-C, HDL-C at the point of 31 months from treating\r\n                  changed lipid-lowering drug.","criteria":"\n        Inclusion Criteria:\r\n\r\n        Among the patients, who has been hospitalized or visited the Outpatient Department OPD, who\r\n        has dyslipidemia of type 2 diabetes.\r\n\r\n          1. Patients have the result of lipid parameter test at baseline and after lipid-lowering\r\n             drug for at least 3 months.\r\n\r\n          2. Patients who have the result of lipid paraneter test (LDL-C 100mg/dL, TG 150mg/dL)\r\n             at baseline.\r\n\r\n          3. Patients who have no received lipid lowering drug fr at least 2 months prior to the\r\n             baseline.\r\n\r\n          4. Patients' age were > 20 years and <75 year.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients who ahs HbA1c9%\r\n\r\n          2. Patients who have no the result of lipid parameter test at baseline and at baseline\r\n             and after lipid-lowering drug for at least 3 months\r\n\r\n          3. Patients who have history of drug discontinuation by incresed liver enzyme or\r\n             rhabdomyolysis.\r\n\r\n          4. Patients received lipid-lowering drug and TZD(Thiazolidinediones) in study period\r\n\r\n          5. Renal abnormality\r\n\r\n          6. Alcoholism or Alcohol abuse\r\n\r\n          7. Patients treated by Steroids.\r\n\r\n          8. Pregnant or lactating woman\r\n\r\n          9. Patients who are judged as not suitable for this study by Investigator.\r\n      ","sponsor":"Yooyoung Pharmaceutical Co., Ltd.","sponsor_type":"Industry","conditions":"Complex Dyslipidemia","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Variation of the Lipid parameter pattern patients who are treated by lipid-lowering drug.","time_frame":"Over 3±1 months","description":"Increasing LDL-C + Triglyceride(TG)Decreasing HDL-C + Increasing TG"},{"outcome_type":"secondary","measure":"The reason why changed drug dosage and pharmacotherapy after patients taken lipid-lowering drug.","time_frame":"Over 3±1 months","description":"Increasing LDL-C + TG Decreasing HDL-C + Increasing TG"},{"outcome_type":"secondary","measure":"Variation for lipid parameter when the patients who are treated for 3±1 months by lipid-lowering drug.","time_frame":"Over 3±1 months","description":"Increasing LDL-C + TGDecreasing HDL-C + Increasing TG"},{"outcome_type":"other","measure":"Setting the sub-group by the result of lipid parameter","time_frame":"Basis on the Base-line","description":"Decreasing HDL-C: HDL-C≤40mg/dL(Man), ≤50mg/dL(Woman) Non-decreasing HDL-C: HDL-C≤40mg/dL(Man), >50mg/dL(Woman)"}]}
{"nct_id":"NCT01250782","start_date":"2010-10-31","phase":"Phase 2","enrollment":150,"brief_title":"Effectiveness of Dipeptide N (2)-L-Alanyl-L-Glutamine in Trauma ICU Patients: Pilot, Prospective, Randomized and Double Blind Study.","official_title":"Effectiveness of Dipeptide N (2)-L-Alanyl-L-Glutamine in Trauma ICU Patients: Pilot, Prospective, Randomized and Double Blind Study.","primary_completion_date":"2012-09-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2012-10-31","last_update":"2010-12-01","description":"Recent reports suggest that most beneficial results of glutamine have been obtained with the parenteral administration of high doses of glutamine (0.35 g/Kg/d) and in some special group of patients, such as traumatic patients. Nevertheless total parenteral nutrition is not often used in critically ill patients. The endovenous administration of the the dipeptide N(2)-L-alanyl-L-glutamine in trauma ICU patients can reduce the number of infections, ICU length of stay and mortality. This benefit can be achieved independently the type of nutrition (enteral or parenteral nutrition), being a pharmaconutrient.","other_id":"GlnHSD-001-09","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Moderate to severe trauma, as defined by an Injury Severity Score (ISS) > 10 points\r\n             were included in the study.\r\n\r\n          -  Traumatic patients who required enteral or parenteral nutrition during the first 48\r\n             hours after hospital admission\r\n\r\n          -  Written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  patients whose life expectancy was less than 5 days,\r\n\r\n          -  who were allergic to glutamine,\r\n\r\n          -  Patients included in any other trial\r\n\r\n          -  Cirrhotic patients (Child C)\r\n\r\n          -  Chronic renal failure\r\n      ","sponsor":"Hospital Universitari Son Dureta","sponsor_type":"Other","conditions":"Trauma ICU Patients","interventions":[{"intervention_type":"Drug","name":"Drug: Glutamine","description":"0.5 g/kg/day of dipeptide N (2)-L-Alanyl-L-Glutamine"},{"intervention_type":"Drug","name":"Drug: Physiological serum","description":"100 mL of physiological serum indistinguishable from active comparator"}],"outcomes":[{"outcome_type":"primary","measure":"Number of infections","time_frame":"ICU discharge (median ten days)","description":"Based on the results of the ENVIN trial, the median ICU length of stay of trauma patients admitted to the ICU in Spain, is 10 days."},{"outcome_type":"secondary","measure":"ICU Mortality","time_frame":"ICU mortality measured at 1 month after hospital admission"},{"outcome_type":"secondary","measure":"SAfety of endovenous administration","time_frame":"5 days from the beginning of treatment"}]}
{"nct_id":"NCT01230138","start_date":"2010-09-30","phase":"Phase 2","enrollment":252,"brief_title":"Pivotal Efficacy and Safety Registration Trial of FP187 in Moderate to Severe Plaque Psoriasis","official_title":"A Randomised, Double Blind, Placebo Controlled Efficacy and Safety Trial of Different Doses/Dose Regimens of FP187 Compared to Placebo in Moderate to Severe Plaque Psoriasis (Pivotal Registration Study)","primary_completion_date":"2012-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-05-31","last_update":"2012-12-11","description":"The purpose of this trial is to investigate the efficacy and safety of different doses and dose administrations of FP187 compared to a placebo treatment in patients with moderate to severe plaque psoriasis.","other_id":"FP187-201","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":90,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients of either sex at least 18 years of age\r\n\r\n          -  A clinical diagnosis of plaque psoriasis defined as skin areas with erythema,\r\n             induration and scaling, with a body surface area of no less than 10% and in total to\r\n             be scoring at least 10 on the PASI scale\r\n\r\n          -  The psoriasis disease have been stable for at least 6 months at randomization\r\n\r\n          -  Signed and dated informed consent\r\n\r\n          -  Sexually active females of childbearing potential must be either surgically sterile\r\n             (hysterectomy or tubal ligation) or use a highly effective (failure rate < 1%)\r\n             medically accepted contraceptive method during the trial as well as one month after\r\n             trial is finished such as:\r\n\r\n               -  Systemic contraceptive (oral, implant, injection),\r\n\r\n               -  Intrauterine device (IUD) inserted for at least one month prior to study entrance\r\n\r\n          -  Willingness and ability to comply with the trial procedures\r\n\r\n          -  Patient is beside the psoriasis disease in good general health in the opinion of the\r\n             Investigator, as determined by medical history, physical examination, vital signs and\r\n             clinical laboratory parameters (hematology, biochemistry and urinalysis).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Female patients who are pregnant or breast-feeding or planning to become pregnant up\r\n             to 7 months from treatment start as well as male patients plan-ning pregnancy with\r\n             their partner up to 7 months from treatment start or practise unprotected sexual\r\n             relationship up to 7 months from treatment start\r\n\r\n          -  Known allergy to any of the constituents of the product being tested\r\n\r\n          -  Pustular forms of psoriasis, erythrodermic or guttate psoriasis\r\n\r\n          -  Known immunosuppressive diseases (e.g., AIDS/HIV)\r\n\r\n          -  Presence of another serious or progressive disease which, according to the\r\n             Investigator may interfere with treatment outcome\r\n\r\n          -  Active skin disease such as atopic dermatitis, rosacea, lupus erythematosus, or other\r\n             inflammatory or infectious skin disease which, according to the Investigator may\r\n             interfere with treatment outcome\r\n\r\n          -  Use of topical medical treatment or UVB treatment - Use of systemic anti-psoriatic\r\n             treatment preceding the baseline visit Methotrexate, cyclosporine, steroids or PUVA\r\n             treatment within x weeks; Biological treatment (efalizumab, adalimumab, infliximab,\r\n             etanercept) within xx weeks; Acitretin within x months; Treatment with Fumaderm or\r\n             other DMF containing products during past xx weeks prior to baseline visit;\r\n             Discontinuation of previous treatment with Fumaderm or other DMF containing products\r\n             due to lack of efficacy or side effects;\r\n\r\n          -  Has within the past x weeks prior to baseline visit been treated with drugs\r\n             influencing the course of the psoriasis such as antimalarial drugs, beta-blockers or\r\n             lithium\r\n\r\n          -  Has a relevant clinical history of stomach or intestinal problems (eg gastritis or\r\n             peptic ulcer within the last 10 years )\r\n\r\n          -  Has liver enzyme measures (AST, ALT, Gamma-GT) higher than 2x UNL)\r\n\r\n          -  Has an estimated Creatinine Clearance: < xx ml/min\r\n\r\n          -  Has leucopenia (leukocyte count < x/mm3) or eosinophilia (count >x/l) or lymphopenia\r\n             (count < x/nl).\r\n\r\n          -  Has protein in the urine test at screening or baseline visit\r\n\r\n          -  Participation in another clinical trial during the last month preceding the baseline\r\n             visit or participation in a trial with treatment of biologicals within x months prior\r\n             to baseline visit\r\n\r\n          -  Patients who are involved in the organisation of the clinical investigation or are in\r\n             any way dependant on the investigator or sponsor\r\n      ","sponsor":"Forward-Pharma GmbH","sponsor_type":"Industry","conditions":"Plaque Psoriasis","interventions":[{"intervention_type":"Drug","name":"Drug: FP187","description":"High daily dose of 750mg administered as 250mg TID"},{"intervention_type":"Drug","name":"Drug: FP187","description":"High daily dose of 750mg administered as 375mg BID"},{"intervention_type":"Drug","name":"Drug: FP187","description":"Low daily dose of 500mg FP187 administered as 250mg BID"},{"intervention_type":"Drug","name":"Drug: FP187","description":"Oral tablets, up to 3 times daily for 20 weeks."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo tablets"}],"outcomes":[{"outcome_type":"primary","measure":"Proportion of patients achieving PASI 75 compared to placebo","time_frame":"After 20 weeks of treatment","description":"Proportion of patients achieving PASI75 (a reduction in the PASI score of 75% or more)"},{"outcome_type":"secondary","measure":"PASI 75","time_frame":"At week 4, 8, 12 and 16","description":"Proportion of patients achieving PASI75 (a reduction of the PASI score of 75% or more compared to baseline)"},{"outcome_type":"secondary","measure":"PASI 50","time_frame":"At week 4, 8, 12, 16 and 20","description":"Proportion of patients who achieves PASI 50 (a reduction of the PASI score of 50% or more compared to baseline)"},{"outcome_type":"secondary","measure":"PASI 90","time_frame":"At week 4, 8, 12, 16 and 20","description":"Proportion of patients achieving PASI90 (a reduction of the PASI score of 90% or more compared to baseline"},{"outcome_type":"secondary","measure":"PGA (Physicians Global Assessment)","time_frame":"At week 4, 8, 12, 16 and 20","description":"On a 5-point scale from 0 (abscence or very mild disease) to 4 (very severe disease) proportion of patients being responders - defined as patients achieving either a score of 0 or 1 or a two point improvement"},{"outcome_type":"secondary","measure":"PaGA (Patients Global Assessment","time_frame":"At week 4,8,12,16 and 20","description":"Patients evaluation on a 5-point Likert scale 1 (very good) - 5 (very poor)based on the evaluation of: \"Considering all the ways your psoriasis affects you, how have you been doing in the last 24 hours?\""},{"outcome_type":"secondary","measure":"Pruritus","time_frame":"At week 4, 8, 12, 16 and 20","description":"Patient evaluation of pruritus measured on a VAS (Visual Analog Scale) from 0mm (no pruritus) to 100mm (worst possible pruritus)"},{"outcome_type":"secondary","measure":"Patient rated QoL (Quality of Life)","time_frame":"At week 4, 8, 12, 16 and 20","description":"Patient filling in 10 questions on the DLQI QoL system with a calculated summary score and analysis of the improvement from baseline"},{"outcome_type":"secondary","measure":"Adverse events (AEs)","time_frame":"At week 4, 8, 12, 16 and 20","description":"Summary of incidense and severity of AEs and ADRs (Adverse Drug Reactions)/SAEs (Serious Adverse Events)/SUSARs (Suspected Unexpected Serious Adverse Reactions)"},{"outcome_type":"secondary","measure":"Safety lab test","time_frame":"At week 20","description":"Summary of lab parameters and clinically relevant changes over the treatment period in standard clinical chemistry tests, standard haematology tests and urin dip stick test"}]}
{"nct_id":"NCT01178944","start_date":"2010-09-30","phase":"Phase 2","enrollment":35,"brief_title":"Pralatrexate and Oxaliplatin in Treating Patients With Unresectable or Metastatic Esophageal, Stomach, or Gastroesophageal Junction Cancer","official_title":"Pralatrexate in Combination With Oxaliplatin in Advanced Esophago-gastric Cancer: A Phase II Trial With Predictive Molecular Correlates","primary_completion_date":"2015-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-11-30","last_update":"2017-12-13","description":"This phase II trial studies how well pralatrexate and oxaliplatin work in treating patients with esophageal, stomach, or gastroesophageal junction cancer that cannot be removed by surgery or has spread from the primary site (place where it started) to other places in the body. Pralatrexate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pralatrexate with oxaliplatin may be an effective treatment for esophageal, stomach, or gastroesophageal junction cancer.","other_id":"I 169210","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically confirmed carcinoma of the esophagus, stomach or gastro-esophageal\r\n             junction that is metastatic, or locally advanced and inoperable for cure; histological\r\n             sub-types permitted include adenocarcinoma, squamous-cell carcinoma, or\r\n             undifferentiated carcinoma; small-cell carcinoma variant is not eligible\r\n\r\n          -  No previous systemic therapy for metastatic or recurrent disease; therapy\r\n             (chemotherapy, radiotherapy, or both) administered in the neo-adjuvant, adjuvant, or\r\n             definitive setting for previously localized disease is permitted, provided it was\r\n             completed more than 6 months prior to enrollment; palliative radiotherapy is permitted\r\n             provided it is completed >= 3 weeks prior to study therapy initiation\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2\r\n\r\n          -  Life expectancy >= 12 weeks\r\n\r\n          -  Hemoglobin >= 9 g/dl\r\n\r\n          -  Absolute neutrophil count >= 1500/mm^3\r\n\r\n          -  Platelet count >= 100,000/mm^3\r\n\r\n          -  Serum creatinine =< institutional upper limit normal (ULN)\r\n\r\n          -  Bilirubin =< 1.5 x ULN\r\n\r\n          -  Transaminases =< 3 x ULN; for documented liver metastases, transaminases up to 5 x ULN\r\n             is permitted\r\n\r\n          -  No evidence of >= grade 2 peripheral neuropathy\r\n\r\n          -  Patients with reproductive potential must be willing to use an adequate contraceptive\r\n             method (e.g., abstinence, intrauterine device, oral contraceptives, barrier device\r\n             with spermicide or surgical sterilization) during treatment and for three months after\r\n             completing treatment; a negative pregnancy test is required for women of child-bearing\r\n             potential; nursing women are ineligible\r\n\r\n          -  Written, informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Hypersensitivity to platinum compounds\r\n\r\n          -  Uncontrolled inter-current illness including but not limited to active infection,\r\n             symptomatic congestive heart failure, unstable angina, uncontrolled cardiac\r\n             arrhythmia, or psychiatric illness that would limit compliance with study requirements\r\n\r\n          -  Presence of brain metastases\r\n\r\n          -  Patients with third-space (pleural, peritoneal) fluid not controllable with usual\r\n             drainage methods are not eligible\r\n\r\n          -  History of second primary malignancy within 3 years prior to enrollment, except for\r\n             in-situ cervix carcinoma or non-melanoma skin cancer\r\n\r\n          -  Undergone an allogeneic stem cell transplant\r\n      ","sponsor":"Roswell Park Cancer Institute","sponsor_type":"Other","conditions":"Adenocarcinoma of the Gastroesophageal Junction|Esophageal Undifferentiated Carcinoma|Gastric Adenocarcinoma|Gastric Squamous Cell Carcinoma|Recurrent Esophageal Adenocarcinoma|Recurrent Esophageal Squamous Cell Carcinoma|Recurrent Gastric Carcinoma|Stage IIIB Esophageal Adenocarcinoma|Stage IIIB Esophageal Squamous Cell Carcinoma|Stage IIIB Gastric Cancer|Stage IIIC Esophageal Adenocarcinoma|Stage IIIC Esophageal Squamous Cell Carcinoma|Stage IIIC Gastric Cancer|Stage IV Esophageal Adenocarcinoma|Stage IV Esophageal Squamous Cell Carcinoma|Stage IV Gastric Cancer|Undifferentiated Gastric Carcinoma","interventions":[{"intervention_type":"Other","name":"Other: Laboratory Biomarker Analysis","description":"Correlative studies"},{"intervention_type":"Drug","name":"Drug: Oxaliplatin","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: Pralatrexate","description":"Given IV"}],"outcomes":[{"outcome_type":"primary","measure":"Overall Response Rate","time_frame":"Up to 5 years","description":"Overall response rate to combination pralatrexate and oxaliplatin as assessed by Response Evaluation Criteria in Solid Tumors version 1.1. Objective responses will be confirmed 4 weeks after first documentation of response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."},{"outcome_type":"secondary","measure":"Number of Participants With an Adverse Event","time_frame":"Up to 30 days after the last dose of study drug(s)","description":"Number of participants with an adverse event. Please refer to the adverse event reporting for more detail. Incidence of toxicity as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0"},{"outcome_type":"secondary","measure":"Overall Survival (OS)","time_frame":"From the date of study enrollment to the time of death from any cause, assessed up to 5 years","description":"Estimated using the Kaplan-Meier method and proportional hazards models."},{"outcome_type":"secondary","measure":"Time to Progression (TTP)","time_frame":"From the date of study enrollment to the first observation of progressive disease, assessed up to 5 years","description":"Estimated using the Kaplan-Meier method and proportional hazards models."},{"outcome_type":"other","measure":"Overall Survival (OS) for SNP ATIC/AICART - s10932606 Genotypes","time_frame":"From the date of study enrollment up to 5 years","description":"Kaplan-Meier estimates of median survival time for each genotype"},{"outcome_type":"other","measure":"MicroRNA Expression - miR-215-5p","time_frame":"Baseline","description":"Mean microRNAs expression of mi-215-5p in tumor tissues of responders and non-responders using a microfabricated device called a gene chip."}]}
{"nct_id":"NCT01226407","start_date":"2010-09-30","phase":"Phase 1","enrollment":36,"brief_title":"Examine Maximum Tolerated Dose and Pharmacokinetic and Pharmacodynamic Profile","official_title":"Phase I Study of CG200745 to Examine the Maximum Tolerate Dose, Pharmacokinetic and Pharmacodynamic Profiles, and Safety Among Patients With Progressive Solid Cancer","primary_completion_date":"2013-02-28","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2013-02-28","last_update":"2012-12-31","description":"Open label, single dose and phase I study. The primary objective: To determine the maximum tolerated dose in Single dose The secondary objective: to evaluate the toxicity in administration to determine desirable dosing amount for phase II to evaluate tumor response in progressive solid cancer patients to evaluate pharmacokinetic/ pharmacodynamic profile.","other_id":"CG200745-1-01","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":69,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  from 20 years old to 69 years old\r\n\r\n          -  diagnosed with progressive solid cancer\r\n\r\n          -  In spite of standard chemotherapies, the efficacy of the treatment or life extension\r\n             cannot be expected.\r\n\r\n          -  Evaluated 0-1 of ECOG\r\n\r\n          -  Expected life duration is within 3 months\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Major surgery except tumor-removal surgery received within 2 weeks of screening.\r\n\r\n          -  history of CNS metasis\r\n\r\n          -  hyper-sensitivy of study drug\r\n\r\n          -  pregancy or lactating\r\n\r\n          -  administered other HDAC inhibitor within 4 weeks of screening\r\n      ","sponsor":"CrystalGenomics, Inc.","sponsor_type":"Industry","conditions":"Solid Tumour","interventions":[{"intervention_type":"Drug","name":"Drug: CG200745","description":"Multiple administration (IV) over the cycles untile MTD/LTD"}],"outcomes":[{"outcome_type":"primary","measure":"To determine the maximum tolerated dose in Single dose","time_frame":"On 22 days after administration"}]}
{"nct_id":"NCT01253109","start_date":"2010-09-30","enrollment":15,"brief_title":"Continuous Intraocular Pressure (IOP) Monitoring in Pigmentary Dispersion Syndrome and Pigmentary Glaucoma Patients","official_title":"Detection of Induced IOP Fluctuations by SENSIMED Triggerfish in Pigmentary Syndrome and Glaucoma Patients","primary_completion_date":"2011-11-30","study_type":"Observational","rec_status":"Terminated","completion_date":"2011-11-30","last_update":"2012-01-24","description":"This study monitors the intraocular pressure (IOP) over 4 to 6 hours using the SENSIMED Triggerfish device and Goldmann Applanation Tonometry (GAT) in pigment dispersion syndrome and pigmentary glaucoma patients. The aim of the study is to detect SENSIMED Triggerfish output signal peak after induced fluctuation by physical exercise or pupil dilation.","other_id":"09/11","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":60,"population":"Patients with confirmed diagnosis of pigmentary dispersion syndrome or pigmentary glaucoma\r\n        on both eyes","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Confirmed diagnosis of pigmentary dispersion syndrome or pigmentary glaucoma on both\r\n             eyes\r\n\r\n          -  IOP of  15 mmHg\r\n\r\n          -  18-60 years.\r\n\r\n          -  Patients able to jog continuously for at least 25 minutes\r\n\r\n          -  Phakic eyes\r\n\r\n          -  Patients who accept signing an informed consent approved by the Ethics Committee.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pigmentary glaucoma already treated with peripheral laser iridotomy (PLI), argon laser\r\n             peripheral iridoplasty (ALPI), argon laser trabeculoplasty (ALT) and selective laser\r\n             trabeculoplasty (SLT) in any eye\r\n\r\n          -  Patients treated with pilocarpine or other mydriatic agent within the last 4 weeks in\r\n             any eye\r\n\r\n          -  Anti-hypertensive treatment in the 4 weeks preceding the study and throughout the\r\n             study. Following signature of informed consent, anti-hypertensive treatment will be\r\n             washed out for 4 weeks prior to study procedures in enrolled patients\r\n\r\n          -  Patients with pseudoexfoliative (PEX) syndrome or PEX glaucoma in any eye\r\n\r\n          -  Patients not able to understand the nature of the research\r\n\r\n          -  Patients under tutorship\r\n\r\n          -  Corneal abnormality\r\n\r\n          -  Subjects with contraindications for wearing contact lenses\r\n\r\n          -  Full frame metal glasses during SENSIMED Triggerfish monitoring\r\n\r\n          -  History of other ocular surgery except uncomplicated strabismus surgery no later than\r\n             3 months prior to study procedures\r\n\r\n          -  Ocular inflammation or infection\r\n\r\n          -  History of cardiac or pulmonary disorder\r\n\r\n          -  Pregnancy and lactation\r\n\r\n          -  Simultaneous participation in other clinical research\r\n      ","sponsor":"Sensimed AG","sponsor_type":"Industry","conditions":"Pigmentary Dispersion Syndrome|Pigmentary Glaucoma Patients","interventions":[{"intervention_type":"Device","name":"Device: SENSIMED Triggerfish","description":"Contact lens-based device for continuous IOP monitoring"}],"outcomes":[{"outcome_type":"primary","measure":"SENSIMED Triggerfish output values","time_frame":"during 4 to 6 hours","description":"Patients will undergo 2 sessions of 4 to 6 hours SENSIMED Triggerfish continuous intraocular pressure monitoring in a selected eye, during and/or after physical exercise and pupile dilation"},{"outcome_type":"primary","measure":"Goldmann Applanation Tonometry values","time_frame":"During 4 to 6 hours","description":"GAT IOP readings will be done in the other eye at regular intervals during 4 to 6 hours SENSIMED Triggerfish IOP monitoring"}]}
{"nct_id":"NCT01196377","start_date":"2010-09-30","phase":"N/A","enrollment":16,"brief_title":"Optimal Albuterol Regimens for Acute Asthma Exacerbations: DBRCT Pilot Study","official_title":"Personalized Medicine, Biomarker-based Study of Optimal Albuterol Regimens for Acute Asthma Exacerbations: DBRCT Pilot Study","primary_completion_date":"2010-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-10-31","last_update":"2017-09-29","description":"Our overall objective is to model a pediatric Acute Asthma Clinical Decision Rule (ADR) for personalized medicine by identification of treatment-response phenotypes that are important determinants of outcome. The Specific Aim of this study is to determine the feasibility of this approach by enrolling a pilot cohort of 16 participants in this DBRCT of 4 different albuterol treatment regimens, 2 of which will use 10mg/hr and 2 of which will use 25mg/hr. Within these dosages there will be a pulsed-treatment regimen and a continuous regimen.","other_id":"100725","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":5,"maximum_age":17,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Doctor diagnosed asthma\r\n\r\n          -  Acute asthma exacerbation\r\n\r\n          -  Treatment with systemic corticosteroids and nebulized albuterol\r\n\r\n          -  Ages 5 to 17 years\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Other acute or chronic lung disease\r\n      ","sponsor":"Vanderbilt University Medical Center","sponsor_type":"Other","conditions":"Acute Asthma","interventions":[{"intervention_type":"Drug","name":"Drug: Albuterol","description":"Nebulized albuterol"}],"outcomes":[{"outcome_type":"primary","measure":"%FEV1","time_frame":"2 hours","description":"% predicted forced expiratory volume in 1-second as a measure of airway obstruction"}]}
{"nct_id":"NCT01198834","start_date":"2010-09-30","phase":"Phase 3","enrollment":600,"brief_title":"MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Ankle Sprains","official_title":"A Randomized, Multi-Center, Double-Blind, Factorial, Comparator and Placebo-Controlled Phase III Trial to Evaluate the Efficacy, Tolerability and Safety of MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Ankle Sprains","primary_completion_date":"2011-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-06-30","last_update":"2018-01-17","description":"A Randomized, Multi-Center, Double-Blind, Factorial, Comparator and Placebo-Controlled Phase III Trial to Evaluate the Efficacy, Tolerability and Safety of MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Ankle Sprains","other_id":"MRX-7EAT-1005","allocation":"Randomized","intervention_model":"Factorial Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":14,"population":"","criteria":"\n        Inclusion Criteria\r\n\r\n        A subject will be eligible for inclusion in this study if all of the following criteria\r\n        apply:\r\n\r\n          1. Subject has signed an informed consent form.\r\n\r\n          2. Subject is 14 years of age or older (with assent according to state law).\r\n\r\n          3. Females of child bearing potential must have a negative pregnancy test and be using an\r\n             adequate method of birth control. Adequate is defined as either hormonal or partner\r\n             vasectomy for at least three months, or , condoms, IUD, abstinence or other prescribed\r\n             birth control. Females may be considered non-childbearing if post-menopausal at least\r\n             1 year or surgically sterile.\r\n\r\n          4. Subject has a diagnosis of uncomplicated acute soft tissue inversion injury of the\r\n             ankle, Grade II classification (as defined by the American Academy of Orthopaedic\r\n             Surgeons (AAOS), \"partial tearing of the ligament\") that has occurred  6 hours to \r\n             48 hours before study entry.\r\n\r\n          5. Subject has a Current Pain Intensity during point and flex with the ankle unwrapped\r\n             rated prior to study entry as  5 but  8 on an NPRS (11 point; range 0 to 10; anchors\r\n             to be \"none\" and \"severe\").\r\n\r\n          6. Subject is willing and able to comply with the protocol.\r\n\r\n        Exclusion Criteria\r\n\r\n        A subject will not be eligible for inclusion in this study if any of the following criteria\r\n        apply:\r\n\r\n          1. Females of child bearing potential that are not using an adequate method of birth\r\n             control or are breastfeeding (adequate defined as either hormonal or partner vasectomy\r\n             for at least three months, or other prescribed birth control, condoms, IUD, abstinence\r\n             or other prescribed birth control).\r\n\r\n          2. Subject has a Grade I (\"slight stretching and some damage to the fibers (fibrils) of\r\n             the ligament\") or Grade III (\"complete tear of the ligament\") sprain or strain,\r\n             bilateral sprain or strain, or concomitant fracture or open wound at the site of the\r\n             sprain or strain, or has a serious injury, as determined by the investigator (e.g.,\r\n             nerve damage, joint instability, or tendon rupture); or surgical treatment is\r\n             required. Diagnosis of Grade III is indicated by a positive anterior drawer test or\r\n             positive talar tilt test is exclusionary (inability to perform test(s) is exclusionary\r\n             when in the opinion of the investigator a Grade III sprain is suspected).\r\n\r\n          3. Subject has a history of a previous injury to the same area within two months prior to\r\n             current injury or previous surgery in the same area.\r\n\r\n          4. Subject has used non-pharmacologic treatments for the injury within 2 hours prior to\r\n             the baseline visit (e.g. ice or acupuncture) that may interfere with pain assessments.\r\n             Subjects on any therapeutic exercise regimen should continue based on the\r\n             investigator's discretion. Use of iontophoresis is prohibited.\r\n\r\n          5. Subject has used oral pharmacologic treatments (NSAIDs or analgesic medications) for\r\n             the injury less than three half-lives before the baseline assessments; ibuprofen is\r\n             permitted prior to baseline as long as it is not within six hours of the baseline\r\n             assessment aspirin (81-325 mg daily) taken prophylactically for cardiovascular reasons\r\n             is permitted.\r\n\r\n          6. Subject has used any form of opioid within 24 hours of study entry or used opioids for\r\n             five or more consecutive days within the 30 days preceding the screening visit.\r\n\r\n          7. Subject has received systemic corticosteroids in the 30 days preceding the screening\r\n             visit (e.g., intra-articular, peritendinous, oral, or parenteral administration);\r\n             topical corticosteroid use is acceptable unless applied to the target joint; and\r\n             inhaled steroids are acceptable (e.g. Flonase).\r\n\r\n          8. Subject recently initiated sleep medications, muscle relaxants, anticonvulsants or\r\n             antidepressants (within the past 30 days); if using any of these, subject must be on a\r\n             stable dose and regimen for 30 days prior to study enrollment.\r\n\r\n          9. Subject has used TNF alpha blockers or Class 1 anti-arrhythmic drugs within the 60\r\n             days preceding the screening visit.\r\n\r\n         10. Subject has a history or physical assessment finding of clinically significant GI\r\n             ulcers or abnormal bleeding, anemia, kidney disease, liver disease, poorly controlled\r\n             lung, stomach, heart, or other vital organ disease as determined by the study\r\n             investigator/physician.\r\n\r\n         11. Subject has a history or physical assessment finding that is not compatible with safe\r\n             participation in the study as determined by the study investigator.\r\n\r\n         12. Subject has any form of inflammatory arthritis, spondyloarthropathies (sPA),\r\n             fibromyalgia, or is currently undergoing treatment for chronic pain; or has a history\r\n             of, or evidence for, underlying disease in the injured area, such as osteoarthritis or\r\n             gout.\r\n\r\n         13. Subject has any pain or medical problem that, in the investigator's opinion, may\r\n             interfere with pain measurement of the target joint.\r\n\r\n         14. Subject has active skin lesions or disease at the intended site of application of the\r\n             study medication. Skin lesions include open wounds, rash, papules and vesicles;\r\n             abrasions, lacerations or any break in skin at the intended site of patch application.\r\n\r\n         15. Subject has a history of allergy to etodolac, other NSAIDs, lidocaine, or adhesives\r\n             (e.g. adhesive tape).\r\n\r\n         16. Subject has a history of prior failed treatment with topical NSAIDs (Flector Patch or\r\n             Voltaren Gel) defined as repeated attempts within the three months preceding the\r\n             screening visit.\r\n\r\n         17. Subject has a history of drug or alcohol abuse within the past two years preceding the\r\n             screening visit.\r\n\r\n         18. Subject has received an investigational drug or product or participated in an\r\n             investigational drug study within a period of 30 days prior to receiving study\r\n             medication.\r\n\r\n         19. Subject has scheduled elective surgery or other invasive procedures during the period\r\n             of study participation.\r\n\r\n         20. Subject is on workman's compensation or has pending legal hearings associated with any\r\n             injury.\r\n\r\n         21. Subject refuses to provide informed consent or is unwilling or unable to follow study\r\n             procedures.\r\n      ","sponsor":"MEDRx USA, Inc.","sponsor_type":"Industry","conditions":"Ankle Sprains","interventions":[{"intervention_type":"Drug","name":"Drug: MRX-7EAT","description":"Application of up to two patches at the discretion of the investigator for up to 7 days."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Application of up to two patches at the discretion of the investigator for up to 7 days."},{"intervention_type":"Drug","name":"Drug: Lidocaine","description":"Application of up to two patches at the discretion of the investigator for up to 7 days."},{"intervention_type":"Drug","name":"Drug: Etodolac","description":"Application of up to two patches at the discretion of the investigator for up to 7 days."}],"outcomes":[{"outcome_type":"primary","measure":"Mean of All Current Pain Intensity During Point and Flex Scores on Days 2 Through 7 on a 0-10 Numeric Pain Rating Scale (NPRS).","time_frame":"Days 2 to 7"},{"outcome_type":"secondary","measure":"Current Pain Intensity during Point and Flex","time_frame":"Days 1 through 7"},{"outcome_type":"secondary","measure":"Current Pain Intensity at Rest, Passive Stretch and Pain Intensity While Standing On a Single Foot","time_frame":"Each Clinical Visit"},{"outcome_type":"secondary","measure":"Impact on Physical Function","time_frame":"Days 1 to 7"},{"outcome_type":"secondary","measure":"Total Number of Patches Used","time_frame":"Days 1 to 7"},{"outcome_type":"secondary","measure":"Time to Pain Resolution","time_frame":"Days 1 to 7"},{"outcome_type":"secondary","measure":"Assessment of Patch Adherence","time_frame":"Clinical Visit 2"},{"outcome_type":"secondary","measure":"Subject's Treatment Satisfaction","time_frame":"Clinical Visit 3"}]}
{"nct_id":"NCT01917461","start_date":"2010-09-30","enrollment":1001,"brief_title":"Observational, Prospective Clinical Study to Evaluate Biomarkers as Indicators of Acute Bacterial or Viral Infections","official_title":"Observational, Prospective Study to Evaluate Biomarkers as Indicators of Bacterial or Viral Infection During Acute Infectious Diseases","primary_completion_date":"2013-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2014-09-30","last_update":"2016-03-08","description":"This is an observational prospective study of an in-vitro diagnostic (IVD) assay planned to enroll 632 subjects. The study will be conducted in two stages: Stage A is aimed at identifying individual biomarkers and constructing a multi-parametric diagnostic model, whereas Stage B is aimed at testing the multi-parametric diagnostic model using a fresh cohort of patients. A collection of clinical, radiological and laboratory data will be gathered in order to establish a final diagnosis. Blood samples will be analyzed and the levels of approximately 700 and 250,000 biomarkers will be determined using immunoassays and molecular measurements respectively. A final diagnosis will be determined based on a majority decision of a panel of three or more independent physicians. Based on the final diagnosis, the accuracy of individual biomarkers and combined sets of biomarkers for differentiating between distinct groups of patients will be evaluated.","other_id":"MM-1001-BV","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":0.08333,"population":"Eligible subjects aged one month of age and older from both genders that attend the\r\n        hospital or the emergency room (ER) due to a suspected acute infectious disease or due to a\r\n        non-infectious disease (e.g. Trauma).","criteria":"\n        Inclusion Criteria:\r\n\r\n        Patients who are at least one month old and are willing (either the subject or his legal\r\n        guardian) to sign an informed consent will be eligible for inclusion. For the infectious\r\n        and non-infectious disease groups, additional inclusion criteria have to be met. These will\r\n        include:\r\n\r\n        In the Infectious disease group:\r\n\r\n          -  Peak fever >37.5C (99.5F)\r\n\r\n          -  Clinical suspicion of an acute infectious disease\r\n\r\n          -  Symptoms duration  12 days\r\n\r\n        In the Non-infectious disease control group:\r\n\r\n        - A non-infectious disease or healthy individuals\r\n\r\n        Exclusion Criteria:\r\n\r\n        Patients who will meet one or more of the following criteria will be excluded from the\r\n        study:\r\n\r\n          -  Evidence of another episode of acute infectious disease in the last two weeks\r\n\r\n          -  Diagnosed congenital immune deficiency (CID)\r\n\r\n          -  Current treatment with immunosuppressive therapy such as: Active\r\n             chemotherapy,Post-transplant drugs,High dose steroids (>1 mg/kg/day prednisone or\r\n             equivalent).\r\n\r\n          -  Active radiotherapy\r\n\r\n          -  Immune-modulating/suppressive drugs including monoclonal antibodies, intravenous\r\n             immunoglobulin (IVIG), cyclosporine, and anti-TNF agents\r\n\r\n          -  Current treatment with immune stimulants such as: Interleukin (IL)-2,\r\n             Granulocyte-Monocytes/Granulocyte colony-stimulating factor (GM/G-CSF),Interferon.\r\n\r\n          -  An active hematological malignancy\r\n\r\n          -  A diagnosis of myelodysplastic syndrome or myeloproliferative disease\r\n\r\n          -  A proven or suspected human immunodeficiency virus (HIV)-1, hepatitis B virus (HBV),\r\n             or hepatitis C virus (HCV) infection\r\n      ","sponsor":"MeMed Diagnostics Ltd.","sponsor_type":"Industry","conditions":"LRTI|UTI|Gastroenteritis|Systemic Infections/Bacteremia/Meningitis|Fever Without Source","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"The sensitivity and specificity of a multi-parametric diagnostic assay in differentiating between bacterial and viral etiology in patients with an acute infectious disease","time_frame":"0-10 days after the initiation of symptoms","description":"We will evaluate the sensitivity and specificity of a multi-parametric diagnostic model, incorporating up to five different blood bio-markers in differentiating between bacterial and viral etiology in patients with an acute infectious disease."},{"outcome_type":"secondary","measure":"The sensitivity and specificity of individual biomarkers in differentiating between bacterial and viral etiology in patients with an acute infectious disease","time_frame":"0-10 days after the initiation of symptoms","description":"We will evaluate the sensitivity and specificity of individual bio-markers in differentiating between bacterial and viral etiology in patients with an acute infectious disease."},{"outcome_type":"secondary","measure":"The sensitivity and specificity of a multi-parametric assay in differentiating between mixed (bacterial and viral co-infection) and pure viral infections in patients with an acute infectious disease","time_frame":"0-10 days after the initiation of symptoms","description":"We will evaluate the sensitivity and specificity of a multi-parametric diagnostic assay incorporating up to five different blood bio-markers, in differentiating between mixed infection(bacterial and viral co-infection) and pure viral infection in patients with an acute infectious disease."}]}
{"nct_id":"NCT02159235","start_date":"2010-09-30","enrollment":200,"brief_title":"Heavy Metals, Angiogenesis Factors and Osteopontin in Coronary Artery Disease (CAD)","official_title":"Heavy Metals (Cadmium, Lead, Mercury, Zinc), Angiogenesis Factors (Endostatin, Angiostatin, VEGF) and Osteopontin in Patients With Coronary Artery Disease","primary_completion_date":"2013-03-31","study_type":"Observational","rec_status":"Completed","completion_date":"2013-04-30","last_update":"2014-06-09","description":"The present study aims is to investigate: 1. whether patients suffering from acute resp. chronic ischemic heart disease show higher levels for cadmium (Cd), lead (Pb) and mercury (Hg) than local and international reference levels suggest; 2. the correlation between severity of coronary artery disease and angiogenic and angiostatic factors (endostatin-ES, angiostatin-AS, VEGF-vascular endothelial growth factor, osteopontin-OPN) The patient population consists of about 270 female and male patients suffering either acute or chronic ischemic heart disease (AIHD:ICD-10 I21; CIHD: ICD-10 I25). 3. whether patients suffering CAD and valve calcification (mitral annulus, aortic valve) show higher levels of endostatin, angiostatin, osteopontin and VEGF compared to patients with CAD but without valve (annulus) calcification The measurement of cadmium (urine), lead, mercury, zinc, endostatin, angiostatin, VEGF (serum) and osteopontin (plasma) in patients with angiographically verified coronary artery disease are in the fore. Furthermore, basic laboratory diagnostics as well as data from coronary angiography and echocardiography will be collected. Additionally, the investigators will inquire heavy metal exposition during life by an interview. Recruitment will be done during the in-patient stay at the General Hospital of Vienna, Medical University of Vienna.","other_id":"EK2010/910","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":80,"population":"Population will be recruited during their in-patient stay at the General Hospital of Vienna","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  patients suffering ICD-10 I21 or I25, age 18-80, female and male, non-smokers or\r\n             ex-smokers for at least 7 years\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  no ICD-10 I21 or I25, patients younger that 18 or older than 80, smoking\r\n      ","sponsor":"Medical University of Vienna","sponsor_type":"Other","conditions":"Ischemic Heart Disease|Coronary Artery Disease|Heavy Metal Toxicity","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"metal levels","time_frame":"3 years","description":"Measurement of cadmium, lead, mercury and zinc in patients with acute or chronic ischemic heart disease (AIHD, CIHD)."},{"outcome_type":"secondary","measure":"Correlation of endostatin-levels (ng/ml) with CAD-severity (Coronary artery score), valve calcification and grade of physical activity (as described in the methods)","time_frame":"3 years","description":"Correlation of endostatin with severity of CAD (defined as described elsewhere) Correlation of endostatin with valve (annulus) calcification Correlation of endostatin with the grade of physical inactivity"},{"outcome_type":"secondary","measure":"Correlation of angiostatin levels (ng/ml) with CAD-severity (Coronary artery score), valve calcification and grade of physical activity (as described in the methods)","time_frame":"3 years","description":"Correlation of angiostatin with severity of CAD (defined as described elsewhere) Correlation of angiostatin with valve (annulus) calcification Correlation of angiostatin with the grade of physical inactivity"},{"outcome_type":"secondary","measure":"Correlation of osteopontin-levels (ng/ml) with CAD-severity (Coronary artery score), valve calcification and grade of physical activity (as described in the methods)","time_frame":"3 years","description":"Correlation of osteopontin with severity of CAD (defined as described elsewhere) Correlation of osteopontin with valve (annulus) calcification Correlation of osteopontin with the grade of physical inactivity"},{"outcome_type":"secondary","measure":"Correlation of VEGF-levels (ng/ml) with CAD-severity (Coronary artery score), valve calcification and grade of physical activity (as described in the methods)","time_frame":"3 years","description":"Correlation of VEGF with severity of CAD (defined as described elsewhere) Correlation of VEGF with valve (annulus) calcification Correlation of VEGF with the grade of physical inactivity"}]}
{"nct_id":"NCT01284816","start_date":"2010-09-30","phase":"N/A","enrollment":44,"brief_title":"Impact of Bariatric Surgery on Epicardial Adipose Tissue and on Myocardial Function","official_title":"Impact of Bariatric Surgery on Epicardial Adipose Tissue and on Myocardial Function","primary_completion_date":"2015-07-31","study_type":"Interventional","rec_status":"Completed","last_update":"2015-07-24","description":"Growing evidence suggests that bariatric surgery is a relevant treatment for severely obese patients, especially those with metabolic complications, as it significantly reduces weight, hypertension and ameliorates glycemic control. Its action on adipose tissue distribution and in particular on epicardial adipose tissue EAT remains unknown. Whether metabolic improvement is associated with EAT reduction is also unknown. The researchers thus investigated the effect of bariatric surgery on EAT in severely obese patients. The primary endpoint of this study was the change in EAT amount 6 months after bariatric surgery.","other_id":"2010-A00696-33","intervention_model":"Crossover Assignment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  men or women who have more than 18 years\r\n\r\n          -  patients have been informed and have consented\r\n\r\n          -  severely obese patients with surgery indication\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  contraindications at surgery, at MNR imagery\r\n\r\n          -  History of infarct, of congenital cardiomyopathy\r\n\r\n          -  Treatment modifying the distribution of the fat\r\n\r\n          -  Pregnant or breast-feeding women\r\n\r\n          -  patients less than 18 years\r\n\r\n          -  Patient without consentment\r\n      ","sponsor":"Assistance Publique Hopitaux De Marseille","sponsor_type":"Other","conditions":"Severely Obese Patients","interventions":[{"intervention_type":"Procedure","name":"Procedure: bariatric surgery","description":"The bariatric surgery is a relevant treatment for severely obese patients those with metabolic complications, as it significantly reduces weight, hypertension and ameliorates glycemic control."}],"outcomes":[{"outcome_type":"primary","measure":"The change in EAT amount 6 months after bariatric surgery.","time_frame":"36 months","description":"We thus investigated the effect of bariatric surgery on EAT in severely obese patients."},{"outcome_type":"secondary","measure":"Evaluation of 3 parameters","time_frame":"36 months","description":"to evaluate the variation in myocardial, hepatic , pancreatic and triglyceride content\r\nto evaluate the variation in left ventricular function or myocardial function\r\nand to describe the relationships between changes in visceral abdominal fat, subcutaneous fat and epicardial fat"}]}
{"nct_id":"NCT01177202","start_date":"2010-09-30","phase":"Phase 1","enrollment":80,"brief_title":"Study of the Safety and Immunogenicity of H1N1 Vaccine","official_title":"A Phase I Dose-Escalation Study to Investigate the Safety and Immunogenicity of the Fusion Protein Recombinant Influenza A (HAC1) Vaccine Derived From Influenza A/California/04/09 (H1N1) in Healthy Adults","primary_completion_date":"2011-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-10-31","last_update":"2016-07-26","description":"The Purpose Of This Study Is To Assess The Safety, Immunogenicity, And Tolerability Of A H1N1 Vaccine In Healthy Adults","other_id":"WRAIR 1758","allocation":"Randomized","intervention_model":"Factorial Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female aged 18 - 50 years inclusive\r\n\r\n          -  Able to give written informed consent to participate\r\n\r\n          -  Score of at least 80% correct on a 10 question multiple-choice quiz (2 attempts)\r\n\r\n          -  Healthy, as determined by medical history, physical examination, weight, vital signs,\r\n             and clinical safety laboratory examinations at baseline\r\n\r\n          -  Females must fulfill one of the following criteria: At least one year post-menopausal;\r\n             Surgically sterile or have a surgically sterile partner; Willing to abstain from\r\n             sexual intercourse; Willing to use a reliable form of contraception approved by the\r\n             investigator (e.g., oral, implantable, transdermal or injectable contraceptives,\r\n             intrauterine device (IUD), female condom, diaphragm with spermicide, cervical cap, or\r\n             male condoms) for 30 days prior to first vaccination through 3 months after second\r\n             vaccination\r\n\r\n          -  Women of childbearing potential must have a negative urine pregnancy test within 24\r\n             hours preceding receipt of each dose\r\n\r\n          -  Comprehension of the study requirements, expressed availability for the required study\r\n             period, and ability to attend scheduled visits and to be contacted by telephone\r\n             throughout the follow-up period\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior receipt of 2010-2011 seasonal influenza vaccine containing\r\n             A/California/04/09-like virus\r\n\r\n          -  Screening H1N1 titer of > 1:40\r\n\r\n          -  Presence of significant uncontrolled medical or psychiatric illness (acute or chronic)\r\n             including institution of new medical or surgical treatment or a significant dose\r\n             alteration for uncontrolled symptoms or drug toxicity within 3 months of screening\r\n\r\n          -  Presence of any medical condition that may be associated with impaired immune\r\n             responsiveness, including diabetes mellitus\r\n\r\n          -  Cancer, or treatment for cancer, within the previous 3 years, excluding basal cell\r\n             carcinoma or squamous cell carcinoma\r\n\r\n          -  Presently receiving or history of receiving, during the preceding 3-month period, any\r\n             medications or other treatments that may adversely affect the immune system: This\r\n             includes allergy injections, immune globulin, interferon, immunomodulators, cytotoxic\r\n             drugs or other drugs known to be frequently associated with significant major organ\r\n             toxicity, or systemic corticosteroids (oral or injectable); Inhaled and topical\r\n             corticosteroids will be allowed\r\n\r\n          -  Receipt of blood or blood products 8 weeks prior to vaccination or planned\r\n             administration during the study period\r\n\r\n          -  Donation of blood or blood products within 8 weeks prior to vaccination or at any time\r\n             during the study\r\n\r\n          -  Receipt or planned administration of a nonstudy vaccine within 30 days prior to\r\n             vaccination; Immunization on an emergency basis with Tetanus Toxoids Adsorbed for\r\n             adult use (Td or Tdap) vaccine up to 8 days before or at least 8 days after a dose of\r\n             study vaccine will be allowed\r\n\r\n          -  History of anaphylactic type reaction to injected vaccines\r\n\r\n          -  Receipt of any investigational product or nonregistered drug within the 30 days prior\r\n             to vaccination or currently enrolled in any investigational drug study or intends to\r\n             enroll in such a study within the ensuing study period\r\n\r\n          -  History of drug or chemical abuse in the year before the study\r\n\r\n          -  Positive serology for HIV-1 or HIV-2, or HBsAg or HCV antibodies\r\n\r\n          -  Unwilling to allow storage of specimens for future use\r\n\r\n          -  Acute disease within 72 hours prior to vaccination: Acute disease is defined as the\r\n             presence of a moderate or severe illness (as determined by the Investigator through\r\n             medical history and physical examination) with or without fever (>38C />100.4F), or\r\n             an oral temperature of >38C orally; Study vaccine can be administered to persons with\r\n             a minor illness.\r\n\r\n          -  Any condition that, in the opinion of the investigator, might interfere with\r\n             interpretation of data supporting the primary study objectives\r\n      ","sponsor":"Fraunhofer, Center for Molecular Biotechnology","sponsor_type":"Industry","conditions":"H1N1 Flu","interventions":[{"intervention_type":"Biological","name":"Biological: HAC1 Vaccine","description":"Subjects will come to the Clinical Trials Center up to 7 days prior to each vaccine dose to have blood drawn for research assays. The first dose of vaccine will be given on Day 0 and the second dose will be given 21 days later ( 3 days). Dose escalation will be staggered by at least 7 days as shown in Figure 1. Subjects from Groups G and H will be vaccinated with each of the other 6 groups. Two subjects from group A will be immunized on study day -1. The immunizations will be performed one hour apart with close monitoring. The remaining eight subjects from Group A will be immunized on study day 0. All subsequent immunizations for each group will occur on the same day. The principal investigator and the medical monitor will review all adverse events and make a determination on whether it is safe to proceed to the next higher dosage group. The control and reference vaccine groups can be vaccinated starting anytime after screening."}],"outcomes":[{"outcome_type":"primary","measure":"To assess the safety, reactogenicity, and tolerability of the HAC1 vaccine formulations.","time_frame":"Six Months","description":"The primary objective of this study is to assess the safety, reactogenicity, and tolerability of the HAC1 vaccine formulations delivered intramuscularly at doses of 15 μg, 45 μg or 90 µg (unadjuvanted or adjuvanted) in healthy adults 18 - 50 years of age."},{"outcome_type":"secondary","measure":"To assess and compare the immunogenicity to 2 injections of the 6 HAC1 vaccine formulations.","time_frame":"Six Months","description":"The secondary objective is to assess and compare the immunogenicity to 2 injections of the 6 HAC1 vaccine formulations using existing research assays and by measuring hemagglutination inhibition (HAI) titers."}]}
{"nct_id":"NCT01207258","start_date":"2010-09-30","phase":"Phase 2","enrollment":600,"brief_title":"Brief Intervention for Problem Drinking and Partner Violence","official_title":"A Randomized Control Trial of Brief Intervention for Problem Drinking and Partner Violence","primary_completion_date":"2015-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-10-31","last_update":"2016-08-22","description":"This study is a randomized controlled trial of a brief intervention for women Emergency Department patients with involvement in both Intimate Partner Violence (IPV) and problem drinking (defined as the full spectrum of hazardous, harmful, or dependent drinking). The study is designed to explore the effectiveness of a low-intensity, gender-sensitive brief motivational intervention, delivered by social workers in the Emergency Department setting, in decreasing IPV and episodes of heavy drinking and increasing rates of follow-up with resources. Social work graduate students and/or staff will be trained to provide brief motivational enhancement therapy (MET) intervention for decreasing heavy drinking and IPV-related injury in women Emergency Department patients.","other_id":"R01AA018705-01A1","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":64,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Registered as an ED patient.\r\n\r\n          -  Able to participate verbally in an English language interview.\r\n\r\n          -  Able to participate cognitively in an English language interview.\r\n\r\n          -  Heavy drinking as assessed by the AUDIT.\r\n\r\n          -  Positive screen for Intimate Partner Violence in the past 3 months.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Intoxication at the time of screening.\r\n\r\n          -  Cognitive impairment or psychosis identified on physical exam or chart review.\r\n\r\n          -  Serious current medical illness or injury, defined as respiratory distress,\r\n             hemodynamic instability, active vomiting, bleeding, labor, severe pain, or acute need\r\n             for hospital admission.\r\n\r\n          -  Suicidal or homicidal ideation by chart review or on the Danger Assessment Scale for\r\n             all assessed patients.\r\n\r\n          -  No identifiable residence or contact phone number.\r\n\r\n          -  Under arrest at the time of ED visit.\r\n\r\n          -  Non-English speaking.\r\n\r\n          -  Previously enrolled in the study.\r\n      ","sponsor":"University of Pennsylvania","sponsor_type":"Other","conditions":"Domestic Violence|Alcohol Abuse","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Motivational Enhancement Therapy","description":"20 minute manual-driven, optionally audio-recorded Motivational Enhancement Training intervention by a MI-trained therapist during their ED visit and a 10-15 minute phone booster at 7 to 10 days."}],"outcomes":[{"outcome_type":"primary","measure":"Effectiveness of brief intervention for decreasing problem drinking and partner violence","time_frame":"Weekly for 3 months; then 6 and 12 months"},{"outcome_type":"secondary","measure":"Assess impact of brief motivational intervention on IPV severity, alcohol quantity/frequency, self-rated health, health behaviors, quality of life, and relationship satisfaction","time_frame":"3, 6, and 12 months."}]}
{"nct_id":"NCT01343810","start_date":"2010-09-30","phase":"N/A","enrollment":87,"brief_title":"Stress Reduction Training to Improve Sleep Quality, Stress Physiology & Cardiovascular Disease (CVD) Risk Markers","official_title":"The Effect of Mindfulness-Based Stress Reduction on Sleep Quality, Stress Physiology & CVD Risk","primary_completion_date":"2013-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-10-31","last_update":"2014-03-10","description":"The goal of this study is to better understand the potential value of reducing stress to ameliorate a cluster of biological and behavioral factors implicated in cardiovascular disease (CVD) risk. These factors include psychological distress, poor sleep quality, and exaggerated physiological responses to emotional stress. Results will be used to develop an innovative brief intervention to reduce risk for CVD by improving sleep quality, ameliorating psychological distress, and attenuating stress physiology.","other_id":"Pro00025227","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Willing to participate in an 8 week stress reduction training program\r\n\r\n          2. Between 18 and 65 years old\r\n\r\n          3. Generally in good health and not taking medication\r\n\r\n          4. Able to speak and read English\r\n\r\n          5. Willing to provide informed consent\r\n\r\n          6. Able to access the internet\r\n\r\n          7. Able to attend 4 study visits at Duke University Medical Center\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Younger than 18 years old/Older than 65\r\n\r\n          2. Asthma\r\n\r\n          3. Allergies\r\n\r\n          4. Arthritis\r\n\r\n          5. Autoimmune disease (Lupus)\r\n\r\n          6. Cancer\r\n\r\n          7. Cardiovascular disease, heart attack, or atherosclerosis\r\n\r\n          8. Diabetes or High Blood Sugar (>124 mg/dl)\r\n\r\n          9. Hypertension or high blood pressure (140/90 mmHg)\r\n\r\n         10. High cholesterol (>240 mg/dl)\r\n\r\n         11. Obesity (Body Mass Index >30)\r\n\r\n         12. Irritable Bowel Syndrome (IBS)\r\n\r\n         13. Mitral Valve Prolapse, or Heart Murmurs\r\n\r\n         14. Irregular Menstrual Cycles (Peri-Menopause Excluded. Menopause may be included.)\r\n\r\n         15. Skin conditions, such as eczema or psoriasis (acne may be included)\r\n\r\n         16. Sleep Apnea\r\n\r\n         17. Depression, anxiety, substance use, or any other mental health diagnosis\r\n\r\n         18. Sleep aids like Tylenol PM or Ambien on a regular basis\r\n\r\n         19. Medication for allergies or asthma on a regular basis\r\n\r\n         20. Aspirin or baby Aspirin on a regular basis\r\n\r\n         21. Oral contraceptives or birth control (women only)\r\n\r\n         22. Hormone Replacement Therapy\r\n\r\n         23. Flu shot within past 3 weeks\r\n\r\n         24. Underweight (BMI < 18.5)\r\n\r\n         25. Current smoker\r\n\r\n         26. >1 alcoholic drink/day (women)/ >2 alcoholic drinks/day (men)\r\n\r\n         27. Hospitalized within the last 3 months\r\n\r\n         28. Treated for any infections within the last 3 months\r\n\r\n         29. Current meditation practice >1x/month\r\n\r\n         30. Previously taken a Mindfulness-Based Stress Reduction (MBSR) course\r\n\r\n         31. Participation in any other research studies in the past year that involved drugs or\r\n             taking blood\r\n\r\n         32. Recently donated blood. (500 cc's in last 8 wks)\r\n      ","sponsor":"Duke University","sponsor_type":"Other","conditions":"Stress, Psychological|Sleep|Inflammation|Cardiovascular Diseases","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Mindfulness Based Stress Reduction (MBSR)","description":"The MBSR program consists of 8 weekly classes that last for 2.5 hours each and a commitment to daily meditation practice for the duration of the course. Classes include didactic instruction on mindfulness and its relationship to stress and health, guided meditation practices, and group discussion. Mindfulness meditation practices include awareness of breathing, awareness of emotions, body scan, mindful hatha yoga, mindful walking, mindful eating, mindful listening, and lovingkindness (metta). Participants are expected to practice formal meditation outside of class for 20-45 min per day, 6 days per week. In addition, participants are encouraged apply mindfulness to everyday activities like eating, communicating with others, and hobbies. Written materials and audio CDs with guided meditations and yoga are provided. The course also includes one full day (7-hours) of meditation on a Saturday following the 6th week of class."},{"intervention_type":"Behavioral","name":"Behavioral: Mindfulness-Based Stress Reduction (MBSR)","description":"The MBSR program consists of 8 weekly classes that last for 2.5 hours each and a commitment to daily meditation practice for the duration of the course. Classes include didactic instruction on mindfulness and its relationship to stress and health, guided meditation practices, and group discussion. Mindfulness meditation practices include awareness of breathing, awareness of emotions, body scan, mindful hatha yoga, mindful walking, mindful eating, mindful listening, and lovingkindness (metta). Participants are expected to practice formal meditation outside of class for 20-45 min per day, 6 days per week. In addition, participants are encouraged apply mindfulness to everyday activities like eating, communicating with others, and hobbies. Written materials and audio CDs with guided meditations and yoga are provided. The course also includes one full day (7-hours) of meditation on a Saturday following the 6th week of class."}],"outcomes":[{"outcome_type":"primary","measure":"Sleep quality","time_frame":"Baseline, post-intervention (2 months), follow-up (8 months)","description":"Sleep quality will be assessed using 3 different methods: daily sleep diaries, questionnaires and actigraphy."},{"outcome_type":"primary","measure":"Stress physiology","time_frame":"Baseline, post-intervention (2 months), follow-up (8 months)","description":"Physiological responses to mild emotional stress (5-minute Anger Recall Task) will be assessed in the laboratory before and after participating in an 8-week Mindfulness-Based Stress Reduction (MBSR) program. During the stress testing sessions, we will take measures of heart rate, blood pressure, stress hormones, metabolism, inflammation, emotions, and mindful qualities."},{"outcome_type":"secondary","measure":"Mindfulness","time_frame":"Baseline, post-intervention (2 months), follow-up (8 months)","description":"Mindful qualities, including observing, describing, non-judging, non-reactivity, acting with awareness, mindfulness, self-kindness, and common humanity."},{"outcome_type":"secondary","measure":"Health-related quality of life","time_frame":"Baseline, post-intervention (2 months), follow-up (8 months)","description":"Global health rating; physical functioning; fatigue; satisfaction with social role; pain intensity and pain-related interference with daily activities."},{"outcome_type":"secondary","measure":"Negative Affect","time_frame":"Baseline, post-intervention (2 months), follow-up (8 months)","description":"Anxiety; anger; depressive symptoms."},{"outcome_type":"secondary","measure":"Cognitive functioning","time_frame":"Baseline, post-intervention (2 months), follow-up (8 months)","description":"Cognitive abilities and concerns, including attention, concentration, memory, organization, and clarity of thinking."},{"outcome_type":"secondary","measure":"Emotion regulation","time_frame":"Baseline, post-intervention (2 months), follow-up (8 months)","description":"Rumination; avoidance; suppression; reappraisal."},{"outcome_type":"secondary","measure":"Stress-related physical symptoms","time_frame":"Baseline, post-intervention (2 months), follow-up (8 months)","description":"Common physical symptoms associated with stress, including muscle tension, gastrointestinal complaints, headaches, etc."}]}
{"nct_id":"NCT01192373","start_date":"2010-09-30","phase":"Phase 2","enrollment":18,"brief_title":"Modulation of Free Fatty Acids in Heart Failure Patients With Diabetes: \"Effect on Left Ventricular Function\"","official_title":"Short Term Modulation of Circulating Free Fatty Acids in Heart Failure Patients With Type 2 Diabetes: \"Effect on Myocardial Lipid Content, Left Ventricular Function and Exercise Capacity\"","primary_completion_date":"2011-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-03-31","last_update":"2013-01-21","description":"The investigators wish to investigate the the short term effect of low circulating free fatty acids in congestive heart failure patients with type 2 diabetes. Hypothesis: Low levels of circulating free fatty acids decrease myocardial and peripheral muscle lipid content, improves cardiac performance and exercise capacity.","other_id":"M20090230","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":30,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  ejection fraction at or lower than 45%\r\n\r\n          -  type 2 diabetes\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  known s-creatinine >220mM\r\n\r\n          -  known S-alanine aminotransferase >3 times normal upper limit\r\n\r\n          -  other disabilitating conditions\r\n\r\n          -  pregnancy\r\n\r\n          -  insulin treatment\r\n      ","sponsor":"University of Aarhus","sponsor_type":"Other","conditions":"Heart Failure|Diabetes","interventions":[{"intervention_type":"Other","name":"Other: Metabolic substrate modulation","description":"for high circulation free fatty acids: Heparin (250IE/hour) + intralipid (20%, 62 ml/hour)."},{"intervention_type":"Other","name":"Other: metabolic substrate modulation","description":"low circulating free acids: hyperinsulinaemic euglycemic clamp (0,8 mUkg/min) with venous blood glucose at 4,5-6,5 mM."}],"outcomes":[{"outcome_type":"secondary","measure":"metabolic and hormonal profile","time_frame":"1-6 weeks","description":"bloodsamples"},{"outcome_type":"primary","measure":"Left ventricular function","time_frame":"1-6 weeks","description":"Left ventricular systolic function (Ejection fraction, tissue velocity, Strain and strain rate).\r\nLeft ventricular diastolic funtion (E/A ratio, E/e' ratio, IVRT) Cardiac output. All parameters measured at rest and peak exercise and outcome is difference between low and high ciculating free fatty acids."},{"outcome_type":"primary","measure":"intracellular lipid content","time_frame":"1-6 weeks","description":"Magnetic Resonans proton spectroscopy (septal myocardial intracellular lipid content) Magnetic Resonans proton spectroscopy (Tibialis anterior muscle intracellular lipid content).\r\nOutcome is difference between low and high ciculating free fatty acids."},{"outcome_type":"primary","measure":"Exercise capacity and oxygen consumption","time_frame":"1-6 weeks","description":"Using treadmill and continues oxygen consumption measurement. Outcome is difference between low and high ciculating free fatty acids."},{"outcome_type":"secondary","measure":"Regional left ventricular function","time_frame":"1-6 weeks","description":"regional speckle tracking during rest and peak exercise. Outcome is difference between low and high ciculating free fatty acids."},{"outcome_type":"secondary","measure":"6 minutes hall walk test","time_frame":"1-6 weeks","description":"distance difference between low and high levels of circulating FFA. Outcome is difference between low and high ciculating free fatty acids."}]}
{"nct_id":"NCT01651754","start_date":"2010-09-30","phase":"N/A","enrollment":72,"brief_title":"Humoral and Cellular Immune Responses After Influenza Vaccination in Patients With Postcancer Fatigue and in Patients With Chronic Fatigue Syndrome","official_title":"Humoral and Cellular Immune Responses After Influenza Vaccination in Patients With Postcancer Fatigue and in Patients With Chronic Fatigue Syndrome.","primary_completion_date":"2011-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-06-30","last_update":"2012-07-27","description":"Postcancer fatigue (PCF) is a frequently occurring, severe and invalidating problem, impairing quality of life. Patients with chronic fatigue syndrome (CFS) also suffer from severe fatigue symptoms. Although it is possible to effectively treat CFS, the nature of the underlying physiology remains unclear. The presence of an underlying immunological problem has been suggested as an explanation for PCF and CFS. The aim of this study is to compare the humoral and cellular immune responses upon influenza vaccination in PCF patients, CFS patients, non-fatigued cancer survivors, and healthy controls. PCF (n=20) and CFS patients (n=20) will be vaccinated against influenza. Age and gender matched non-fatigued cancer survivors (n=20) and healthy controls (n=20) will be included for comparison. Antibody responses will be measured at baseline and at day 21 by a hemagglutination inhibition test. T cell responses will be measured at baseline and at day 7 by lymphocyte proliferation, activation, and cytokine secretion.","other_id":"UMCNONCO201009","allocation":"N/A","intervention_model":"Single Group Assignment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  General inclusion criteria\r\n\r\n          -  Age between 18 and 60 years old\r\n\r\n          -  Written informed consent Inclusion criteria cancer survivors\r\n\r\n          -  Severely fatigued (CIS-fatigue score  35) or non-fatigued (CIS-fatigue < 27)\r\n\r\n          -  Treated for a malignant, solid tumor\r\n\r\n          -  Completion of treatment for cancer minimal 1 year ago\r\n\r\n          -  Disease-free, as defined by the absence of somatic disease activity parameters\r\n\r\n          -  Age at disease onset minimal 18 years Inclusion criteria CFS patients\r\n\r\n          -  Severe, persistent or continuously returning complaints of fatigue, which do not\r\n             improve noteworthy after rest and which are not the consequence of continuous exertion\r\n\r\n          -  The fatigue resulted into a substantial decrease in former levels of professional,\r\n             social and/or personal functioning\r\n\r\n          -  The complaints cannot be explained by a physical cause\r\n\r\n          -  The complaints persist for at least 6 months\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  - Psychological or psychiatric treatment\r\n\r\n          -  Physical comorbidity that could explain the fatigue\r\n\r\n          -  Treatment with anti-depressive drugs, anti-epileptic drugs, or benzodiazepines\r\n\r\n          -  A known immune deficiency\r\n\r\n          -  Treatment with corticosteroids during the last 2 weeks\r\n\r\n          -  Symptoms of influenza\r\n\r\n          -  Allergy for chicken protein\r\n      ","sponsor":"Radboud University","sponsor_type":"Other","conditions":"Postcancer Fatigue|Chronic Fatigue Syndrome","interventions":[{"intervention_type":"Biological","name":"Biological: Seasonal influenza vaccination","description":"single dose of influenza vaccination"}],"outcomes":[{"outcome_type":"primary","measure":"Humoral and cellular immune responses after influenza vaccination in patients with postcancer fatigue and in patients with chronic fatigue syndrome.","time_frame":"before vaccination, 1 and 3 weeks after vaccination (change in immune response from pre- to post-vaccination)","description":"Humoral and cellular immune responses after influenza vaccination in patients with postcancer fatigue and in patients with chronic fatigue syndrome. The humoral immune responses will be measured by the hemagglutination-inhibition antibody test. The cellular immune responses will be measured by T lymphocyte proliferation and cytokine secretion of peripheral blood mononuclear cells. A full blood cell count will be performed and hemoglobin, glucose, and cholesterol levels, iron status, electrolyte balance, erythrocyte sedimentation rate, and thyroid, kidney, and liver function will be checked."}]}
{"nct_id":"NCT00747032","start_date":"2010-09-30","phase":"Phase 3","enrollment":0,"brief_title":"To Demonstrate the Superior Efficacy of NYC 0462 Ointment Over That of the Placebo in the Treatment of Plaque Psoriasis","official_title":"Multi-Center, Double-Blind, Randomized, Vehicle-controlled, Parallel-Group Study Comparing NYC-0462 Ointment To a Vehicle Control","primary_completion_date":"2011-02-28","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2011-04-30","last_update":"2012-05-07","description":"The aim of this trial is to assess the efficacy of NYC-0462 Ointment in the Treatment of Plaque Psoriasis.Treatment medication will be administered as follows: A thin layer of study product will be applied to the affected skin, excluding the face, once daily, at approximately the same time daily.","other_id":"NYC 0462-01-01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosis of stable, symptomatic plaque psoriasis\r\n\r\n          -  Good health with the exception of psoriasis\r\n\r\n          -  % BSA and plaque elevation requirements\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subjects who are pregnant, nursing or planning a pregnancy within the study\r\n             participation period.\r\n\r\n          -  Subjects who have any systemic or dermatological disorders with the exception of\r\n             psoriasis\r\n      ","sponsor":"Fougera Pharmaceuticals Inc.","sponsor_type":"Industry","conditions":"Plaque Psoriasis","interventions":[{"intervention_type":"Drug","name":"Drug: NYC 0462 Ointment","description":"To assess the efficacy of NYC 0462 Ointment versus Placebo in the treatment of Plaque Psoriasis"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"To assess the efficacy of NYC 0462 Ointment versus Placebo in the treatment of Plaque Psoriasis"}],"outcomes":[{"outcome_type":"primary","measure":"Reduction in plaque elevation score","time_frame":"8 weeks"},{"outcome_type":"secondary","measure":"Reduction in Investigator´s Global Evaluation, erythema and scaling scores","time_frame":"8 weeks"}]}
{"nct_id":"NCT01342471","start_date":"2010-09-30","phase":"Phase 1","enrollment":58,"brief_title":"Physical Activity and Leisure-time Study (PALS)","official_title":"TV Commercial Stepping: Can America's Top Sedentary Activity be Made More Active","primary_completion_date":"2011-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-06-30","last_update":"2012-11-09","description":"Physical inactivity is a major public health problem and a primary contributing factor to the obesity epidemic. While most Americans do not meet the physical activity (PA) guidelines (30 min/day, 5 day/wk), they do report watching several hours of TV each day, and frequently site \"lack of time\" as a barrier for engaging in PA. The Physical Activity and Leisure-time Study examines an approach convert sedentary TV watching into active TV watching time by having adults step in place during commercials (TV commercial stepping).","other_id":"UTennessee","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":25,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  25 to 65 years of age\r\n\r\n          -  BMI between 25 and 45 kg/m2\r\n\r\n          -  watch 14 hours per week of TV\r\n\r\n          -  ability to follow instructions and record data\r\n\r\n          -  ability to walk 1/4 mile without stopping\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  history of myocardial infraction, angina, stroke, heart failure, or uncontrolled\r\n             cardiac arrhythmias\r\n\r\n          -  a resting blood pressure greater than 180 mm Hg systolic and/or 100 mm Hg diastolic\r\n\r\n          -  other physical or medical limitations for engaging in physical activity\r\n\r\n          -  no television in the home\r\n\r\n          -  baseline physical activity level exceeding 7,499 steps per day as determined by the\r\n             Omron pedometer\r\n\r\n          -  currently participating in a program to increase PA\r\n\r\n          -  intended to move outside the East Tennessee area within the time frame of the\r\n             intervention\r\n\r\n          -  were pregnant, lactating, less than 6 months post-partum, or planned to become\r\n             pregnant during the time frame of the intervention\r\n\r\n          -  unwilling to attend group intervention meetings, assessments or to complete an\r\n             activity diary for the duration of the study.\r\n      ","sponsor":"University of Tennessee","sponsor_type":"Other","conditions":"Physical Activity|Weight","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: TV commercial stepping","description":"Participants were instructed to stand and \"briskly\" step in place, or \"briskly\" walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"},{"intervention_type":"Behavioral","name":"Behavioral: 30-min walk","description":"Participants were instructed to use \"brisk\" walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"}],"outcomes":[{"outcome_type":"primary","measure":"Physical Activity (Steps/Day)","time_frame":"0 and 6 months","description":"Change in pedometer measured steps per day between 0 and 6 months"},{"outcome_type":"secondary","measure":"Total Energy Intake","time_frame":"0 and 6 months","description":"Change in total energy intake(kcals/day) between 0 and 6 months"},{"outcome_type":"secondary","measure":"TV Related Energy Intake","time_frame":"0 and 6 months","description":"Change in energy intake (kcals/day) while watching TV between 0 and 6 months"},{"outcome_type":"secondary","measure":"Weight","time_frame":"0 and 6 months","description":"Change in weight in kgs between 0 and 6 months"},{"outcome_type":"secondary","measure":"TV Viewing Time","time_frame":"0 and 6 months","description":"Change in self-reported TV viewing time per day between 0 and 6 months"}]}
{"nct_id":"NCT01197157","start_date":"2010-09-30","phase":"Phase 2/Phase 3","enrollment":200,"brief_title":"Study of the Impact of Nitazoxanide on Chronic Hepatitis Patients","official_title":"Impact of Nitazoxanide on Virologic Responses in Chronic HCV Infected Patients With Genotype 4: A Placebo-controlled Randomized Trial","primary_completion_date":"2014-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-04-30","last_update":"2014-09-30","description":"The main objective of antiviral therapy of patients with chronic hepatitis C (CHC) is the sustained elimination of the hepatitis C virus (HCV). The standard of care (SOC) is peginterferon alfa-2a/-2b with ribavirin for 48 weeks or 24 weeks according to HCV genotype. However, this approach is not sufficient to substantially improve the sustained virologic response (SVR) rates. Therefore, new therapies are needed to treat patients with hepatitis C virus (HCV) infection. Nitazoxanide (NTZ), originally used to treat cryptosporidium parvum infection, recently was shown to have an unexpected antiviral activity in the HCV replicon system and in chronically infected patients. The aim of this work is to study impact of nitazoxanide therapy in addition to peginterferon/ribavirin combination on virologic responses in patients with chronic hepatitis C genotype 4. Patients will be enrolled in this study and will be randomly assigned in a 1:1 ratio into 2 groups: Group A: comprises 100 CHC patients who will receive the standard of care treatment, peginterferon-alf 2a plus weight-based ribavirin for 48 weeks. Group B: comprises 100 CHC patients who will receive nitazoxanide monotherapy at a dose of 500 mg twice daily for 12 weeks as a lead-in phase followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a, and weight-based ribavirin for 48 weeks. Data will be collected and statistical analysis will be done comparing the groups regarding response to antiviral therapy. Final results will be discussed and compared to similar studies published in peer reviewed journals and international conferences.","other_id":"NEAR trial","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age > 18 and <60.\r\n\r\n          -  Liver biopsy showing chronic hepatitis with significant fibrosis using Ishak scoring\r\n             system.\r\n\r\n          -  Compensated liver disease; serum bilirubin < 1.5 mg/dl, INR no more than 1.5, serum\r\n             albumin > 3.4, platelet count >75,000 mm, and no evidence of hepatic decompensation\r\n             (hepatic encephalopathy or ascites).\r\n\r\n          -  Acceptable hematological and biochemical indices (hemoglobin 13g/dl for men and 12\r\n             g/dl for women; neutrophil count 1500/mm3 or more and serum creatinine <1.5 mg/dl.\r\n\r\n          -  Willing to be treated and to adhere to treatment requirements\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Major uncontrolled depressive illness.\r\n\r\n          -  Solid organ transplantation.\r\n\r\n          -  Autoimmune conditions, known to be exacerbated by peginterferon and ribavirin.\r\n\r\n          -  Untreated thyroid disease.\r\n\r\n          -  Pregnant or unwilling to comply with adequate contraception.\r\n\r\n          -  Severe concurrent medical disease such as severe hypertension, heart failure,\r\n             significant coronary heart disease, poorly controlled diabetes, chronic obstructive\r\n             pulmonary disease.\r\n\r\n          -  Known hypersensitivity to drugs used to treat HCV.\r\n      ","sponsor":"National Liver Institute, Egypt","sponsor_type":"Other","conditions":"Hepatitis C","interventions":[{"intervention_type":"Drug","name":"Drug: Placebo","description":"Group A: comprises 100 CHC patients who will receive placebo twice daily with food for an average of 12 weeks as a part of monotherapy lead-in phase followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (once weekly), and weight-based ribavirin (1000-1200 mg daily) for 48 weeks."},{"intervention_type":"Drug","name":"Drug: Nitazoxanide","description":" Group B: comprises 100 chronic hepatitis patients who will receive oral Nitazoxanide 500 mg twice daily with food for an average of 12 weeks followed by the standard of care treatment, peginterferon Alfa 2a once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or  75 kg, respectively) in divided doses plus placebo twice daily for 48 weeks."}],"outcomes":[{"outcome_type":"secondary","measure":"Safety of Nitazoxanide","time_frame":"Throughout the study and up to 90 days after the end of triple therapy","description":"Safety of nitazoxanide will be assesses and all adverse events will be reported, and treatment will be discontinued if necessary"},{"outcome_type":"primary","measure":"Assessment of efficacy of Nitazoxanide as an add-on therapy in terms of achieving a sustained virologic response","time_frame":"180 ± 7 days after the end of triple therapy, the preliminary data will be available at least 2 years after the beginning of the study (September 2012)","description":"Patients in the 2 group who will continue on triple therapy till achieving an end-of-treatment response (after 48 weeks from the start of triple therapy), will have their viral load measured 6 months thereafter for assessment of sustained virologic response. patients in whom the virus is undetectble will be regarded as achieving a sustained virologic response."},{"outcome_type":"secondary","measure":"assessment of rapid virologic response","time_frame":"28-35 days from the start of triple therapy","description":"Patients in the 2 groups will have their viral load measured at 4 weeks from the start of triple therapy which is a strong predictor of attaining a sustained virologic response. patients in whom the virus is undetectable will be regarded as achieving a rapid virologic response."},{"outcome_type":"secondary","measure":"Assessment of early virologic response","time_frame":"90 ± 7 days from the start of triple therapy","description":"Patients in the 2 groups will have their viral load measured at 12 weeks from the start of triple therapy. Patients in whom the virus is undetectable, will be regarded as achieving an early virologic response."},{"outcome_type":"secondary","measure":"Assessment of end-of-treatment response","time_frame":"48± one week from the start of triple therapy","description":"Patients in the 2 groups will have their viral load measured at the end of triple therapy (48 weeks). Patients in whom the virus is undetectable, will be regarded as achieving an end-of-treatment response."},{"outcome_type":"secondary","measure":"Assessment of the efficacy of Nitazoxanide monotherapy following the lead-in phase","time_frame":"90± 7 days from the start of the lead_in phase","description":"Patients in the 2 groups will have their viral load as well as transaminases (ALT&AST) measured at the end of the lead-in phase. in case of a reduction in viral load, this will be expressed as log10 reduction from nadir, also, reduction in serum transaminases from pre-treatment values will be regarded as achieving a biochemical response."}]}
{"nct_id":"NCT04029285","start_date":"2010-09-20","phase":"N/A","enrollment":54,"brief_title":"Exergaming Experience of Older People With Chronic Musculoskeletal Pain","official_title":"The Effects of Exergaming on Pain, Postural Control, Technology Acceptance and Flow Experience in Older People With Chronic Musculoskeletal Pain: a Randomised Controlled Trial","primary_completion_date":"2011-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-09-16","last_update":"2019-07-23","description":"Chronic musculoskeletal pain is debilitating and can lower the quality of life in older people. Therapeutic benefits have been reported from exergaming used as an intervention for rehabilitation or alternative to exercise. This study investigated the effects of exergaming in comparison with those of standard exercise on pain, postural control, technology acceptance and flow experience in older people with musculoskeletal pain.","other_id":"ExergamingOldPeople","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","intervention_model_description":"Participants were assigned to either the control group (TGB) or the experimental group (exergaming) in parallel for the duration of the study.","sampling_method":"","gender":"All","minimum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  male or female\r\n\r\n          -  aged 65 years or over\r\n\r\n          -  able to walk unassisted (i.e. did not use, or require, any walking aids) for at least\r\n             0.5 of a mile\r\n\r\n          -  having musculoskeletal pain in two or more joints, of more than 12 weeks duration\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  diagnosis (or suspicion) of any systemic conditions that may cause pain in two or more\r\n             joints\r\n\r\n          -  of more than 12 weeks duration (such as cancer, rheumatic or neurological disease or\r\n             condition)\r\n\r\n          -  self-report of current (or history) of any condition or injury which would contra-\r\n             indicate participation in the exercises under study\r\n\r\n          -  inability (or any doubt of ability) to give informed consent\r\n\r\n          -  inability to read and write English\r\n      ","sponsor":"Teesside University","sponsor_type":"Other","conditions":"Musculoskeletal Pain|Musculoskeletal Pain Disorder","interventions":[{"intervention_type":"Other","name":"Other: Exergaming","description":"The exergaming group played six IREX exergames. Those in the TGB group performed exercises that were matched to the IREX exergames for: movement patterns required, physiological demands, sequence, duration and mode of exercise by adopting open and closed kinetic chain movements, in the same range and loading, across both groups. Each IREX exergame was played for two minutes and was repeated three times within a session. TGB exercise was conducted in sets of two minutes duration, repeated three times within a session. In both groups participants were given rest periods of 10 to 30 seconds, or longer, if required, between exergames or TGB exercise sets."}],"outcomes":[{"outcome_type":"primary","measure":"Change in rate of change of centre of pressure (mm.s-1) location - eyes closed.","time_frame":"Change in rate of change of centre of pressure (mm.s-1) location (eyes closed), from baseline to six weeks","description":"Centre of pressure velocity (mm.s-1) is the rate at which the centre point of force (measured on a Kistler™ Force Plate) moves, as the participant stands on the force plate with their eyes closed.\r\nIt is quantified in mm.s-1 and an increase represents faster movements and hence more rapid corrections of balance are required to maintain equilibrium and hence postural control has worsened."},{"outcome_type":"primary","measure":"Change in score, on each cluster included in the Multi Affect and Pain Survey (MAPS) questionnaire (Clark, 2002).","time_frame":"Change in MAPS Cluster Score, from baseline to six weeks","description":"MAPS comprises three superclusters reflecting three major aspects of pain: somatosensory, emotional and well-being.\r\nsomatosensory supercluster contains 17 clusters with 57 descriptors of painful sensory qualities\r\nemotional supercluster has 8 clusters with 26 descriptors of negative emotional qualities\r\nwell-being supercluster has 5 clusters with 18 descriptors of positive affect, and health.\r\nDescriptors are presented as statements and participants rate how closely each comes to describing how they feel on a six point scale (from 0 (Not at all) to 5 (Very much so)). Descriptor scores are summed to give Cluster scores. An increased score in somatosensory and emotional clusters reflects a worsening, in well-being it reflects an improvement."},{"outcome_type":"primary","measure":"Change in Pain intensity (within previous 30 days) rating","time_frame":"Change in Pain intensity (within previous 30 days) rating, from baseline to six weeks","description":"Participants rated the intensity of their pain (within previous 30 days) on a 0-10 scale where 10 is the WORST POSSIBLE PAIN. An increased score represents greater pain."},{"outcome_type":"primary","measure":"Change in Pain intensity (at present time) rating","time_frame":"Change in Pain intensity (within previous 30 days) rating, from baseline to six weeks","description":"Participants rated the intensity of their pain (within previous 30 days) on a 0-10 scale where 10 is the WORST POSSIBLE PAIN. An increased score represents greater pain."},{"outcome_type":"primary","measure":"Change in rate of change of centre of pressure (mm.s-1) location - eyes open.","time_frame":"Change in centre of pressure velocity (mm.s-1) (eyes open), from baseline to six weeks","description":"Centre of pressure velocity (mm.s-1) is the rate at which the centre point of force (measured on a Kistler™ Force Plate) moves, as the participant stands on the force plate with their eyes open.\r\nIt is quantified in mm.s-1 and an increase represents faster movements and hence more rapid corrections of balance are required to maintain equilibrium and hence postural control has worsened."},{"outcome_type":"primary","measure":"Change in standard deviation of centre of pressure (mm) location measurements in the anterio-posterior direction - eyes open.","time_frame":"Change in standard deviation of centre of pressure (mm) location measurements in the anterio-posterior direction (eyes open), from baseline to six weeks","description":"Centre of pressure (CoP) is the centre point of force (measured on a Kistler™ Force Plate) as the participant stands on the force plate with their eyes open. The location of the CoP changes in the anterio-posterior direction (forwards to backwards) if the person sways forward and backward. The variability in the magnitude of sway is reflected in the Standard Deviation of this measure.\r\nIt is quantified in mm and an increased variation in movement means that more varied corrections of balance are required to maintain equilibrium and hence postural control has worsened."},{"outcome_type":"primary","measure":"Change in range of centre of pressure (mm) location measurements in the anterior-posterior direction - eyes open.","time_frame":"Change in range of centre of pressure (mm) location measurements in the anterior-posterior direction (eyes open), from baseline to six weeks","description":"Centre of pressure (CoP) is the centre point of force (measured on a Kistler™ Force Plate) as the participant stands on the force plate with their eyes open. The location of the CoP changes in the anterio-posterior direction (forwards to backwards) if the person sways forward and backward. The extent of maximal and minimal magnitude of sway is reflected in the Range of this measure.\r\nIt is quantified in mm and an increase represents larger movements occurred and so correspondingly larger corrections of balance are required, to maintain equilibrium and hence postural control has worsened."},{"outcome_type":"primary","measure":"Change in standard deviation of centre of pressure (mm) location measurements in the medio-lateral direction - eyes open.","time_frame":"Change in standard deviation of centre of pressure (mm) location measurements in the medio-lateral direction (eyes open), from baseline to six weeks","description":"Centre of pressure (CoP) is the centre point of force (measured on a Kistler™ Force Plate) as the participant stands on the force plate with their eyes open. The location of the CoP changes in the medio-lateral direction (side-to-side) if the person sways from side to side. The variability in the magnitude of sway is reflected in the Standard Deviation of this measure.\r\nIt is quantified in mm and an increased variation in movement means that more varied corrections of balance are required to maintain equilibrium and hence postural control has worsened."},{"outcome_type":"primary","measure":"Change in range of centre of pressure (mm) location measurements in the medio-lateral direction - eyes open.","time_frame":"Change in range of centre of pressure (mm) location measurements in the medio-lateral direction (eyes open), from baseline to six weeks","description":"Centre of pressure (CoP) is the centre point of force (measured on a Kistler™ Force Plate) as the participant stands on the force plate with their eyes open. The location of the CoP changes in the medio-lateral direction (side-to-side) if the person sways from side to side. The extent of maximal and minimal magnitude of sway is reflected in the Range of this measure.\r\nIt is quantified in mm and an increase represents larger movements occurred and so correspondingly larger corrections of balance are required, to maintain equilibrium and hence postural control has worsened."},{"outcome_type":"primary","measure":"Change in standard deviation of centre of pressure (mm) location measurements in the anterio-posterior direction - eyes closed.","time_frame":"Change in standard deviation of centre of pressure (mm) location measurements in the anterio-posterior direction (eyes closed), from baseline to six weeks","description":"Centre of pressure (CoP) is the centre point of force (measured on a Kistler™ Force Plate) as the participant stands on the force plate with their eyes closed. The location of the CoP changes in the anterio-posterior direction (forwards to backwards) if the person sways forward and backward. The variability in the magnitude of sway is reflected in the Standard Deviation of this measure.\r\nIt is quantified in mm and an increased variation in movement means that more varied corrections of balance are required to maintain equilibrium and hence postural control has worsened."},{"outcome_type":"primary","measure":"Change in range of centre of pressure (mm) location measurements in the anterior-posterior direction - eyes closed.","time_frame":"Change in range of centre of pressure (mm) location measurements in the anterior-posterior direction(eyes closed), from baseline to six weeks","description":"Centre of pressure (CoP) is the centre point of force (measured on a Kistler™ Force Plate) as the participant stands on the force plate with their eyes closed. The location of the CoP changes in the anterio-posterior direction (forwards to backwards) if the person sways forward and backward. The extent of maximal and minimal magnitude of sway is reflected in the Range of this measure.\r\nIt is quantified in mm and an increase represents larger movements occurred and so correspondingly larger corrections of balance are required, to maintain equilibrium and hence postural control has worsened."},{"outcome_type":"primary","measure":"Change in standard deviation of centre of pressure (mm) location measurements in the medio-lateral direction - eyes closed.","time_frame":"Change in standard deviation of centre of pressure (mm) location measurements in the medio-lateral direction (eyes closed), from baseline to six weeks","description":"Centre of pressure (CoP) is the centre point of force (measured on a Kistler™ Force Plate) as the participant stands on the force plate with their eyes closed. The location of the CoP changes in the medio-lateral direction (side-to-side) if the person sways from side to side. The variability in the magnitude of sway is reflected in the Standard Deviation of this measure.\r\nIt is quantified in mm and an increased variation in movement means that more varied corrections of balance are required to maintain equilibrium and hence postural control has worsened."},{"outcome_type":"primary","measure":"Change in range of centre of pressure (mm) location measurements in the medio-lateral direction - eyes closed.","time_frame":"Change in range of centre of pressure (mm) location measurements in the medio-lateral direction(eyes closed), from baseline to six weeks","description":"Centre of pressure (CoP) is the centre point of force (measured on a Kistler™ Force Plate) as the participant stands on the force plate with their eyes closed. The location of the CoP changes in the medio-lateral direction (side-to-side) if the person sways from side to side. The extent of maximal and minimal magnitude of sway is reflected in the Range of this measure.\r\nIt is quantified in mm and an increase represents larger movements occurred and so correspondingly larger corrections of balance are required, to maintain equilibrium and hence postural control has worsened."},{"outcome_type":"primary","measure":"Change in score on each domain included in the Technology Acceptance: United Theory of Acceptance and Use of Technology (UTAUT) questionnaire (Venkatesh, 2003).","time_frame":"Change in score on each domain included in the Technology Acceptance: United Theory of Acceptance and Use of Technology (UTAUT) questionnaire, from baseline to six weeks","description":"The UTAUT comprises statements rated on a 7-point Likert scale, 1 strongly disagree to 7 strongly agree, grouped into six domains.\r\nperformance expectancy, the belief that using a system will help improve performance,\r\neffort expectancy, how easy it is to use the technology\r\nsocial influence, how much the user believes others think they should use the technology\r\nfacilitation conditions, how much the user believes they should use the technology,\r\nself-efficacy, how capable the user feel to use the technology\r\nbehavioural intention, intention to use the technology again.\r\nStatement ratings are summed to give Domain scores. An increased score in any Domain reflects an increase in acceptance (positive outcome in respect of technology usage)."},{"outcome_type":"primary","measure":"Change in score on each sub-scale included in the Flow State Scale (FSS) (Jackson and Marsh, 1996).","time_frame":"Change in score on each sub-scale included in the Flow State Scale questionnaire, from baseline to six weeks","description":"FSS comprises 36 questions rated on a 5-point Likert scale 1 strongly disagree to 5 strongly agree, grouped into nine subscales.\r\nautotelic experience, the intrinsically rewarding experience doing a task\r\nclear goals, clearly confident of action\r\nchallenge-skill-balance, balance between skills and challenge\r\nconcentration at task, complete control on performing a task\r\ncontrol, at full focus at the task\r\nunambiguous feedback, feedback on performing a task\r\naction-awareness-merging, immediate, direct and clear observations whilst performing a task\r\ntransformation of time, sense of time speeds or slows, becomes irrelevant or out of one's awareness\r\nloss of self consciousness, sense of not being concerned with oneself while engaged in a task\r\nQuestion ratings are summed to give subscale score. An increased score in any subscale reflects an increase in the experience of Flow State (a positive outcome in respect of experience of any activity)."}]}
{"nct_id":"NCT01198197","start_date":"2010-09-03","phase":"Early Phase 1","enrollment":41,"brief_title":"PET Brain and Whole Body Distribution Studies for Nociceptin/Orphanin FQ Peptide (NOP) Receptor Using [11C]NOP-1A","official_title":"PET Brain and Whole Body Distribution Studies for Nociceptin/Orphanin FQ Peptide (NOP) Receptor Using [(11)C]NOP-1A","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-02-28","last_update":"2019-12-17","description":"Background: - A small brain protein called nociceptin/orphanin FQ peptide (NOP) receptor may be involved in several brain diseases such as anxiety, depression, drug abuse, and seizures. Researchers are interested in testing a new radioactive chemical that will help locate NOP receptors in the brain during imaging studies such as positron emission tomography (PET) scans. Because this chemical has not yet been approved by the Food and Drug Administration, it is considered to be an experimental drug. Objectives: - To investigate the effectiveness of the experimental chemical [11C]NOP-1A in imaging studies of the nociceptin/orphanin FQ peptide (NOP) receptor. Eligibility: - Healthy volunteers between 18 and 50 years of age who are able to have imaging studies. Design: - This study will involve three or four outpatient visits to the National Institutes of Health Clinical Center. All participants will be screened with a full physical examination, medical history, blood and urine tests, and electrocardiogram. - Participants will be involved in one or more parts of this three-part study as directed by study researchers. Part 1 consists of brain imaging to study how the brain responds to the chemical. Part 2 is a whole body imaging study to evaluate how the chemical is distributed throughout the body after being administered. Part 3 is a set of testing and retesting scans to determine how precise the drug is in locating the NOP receptors in the brain. - Part 1: Participants will have a brain magnetic resonance imaging (MRI) scan. Then the study drug will be administered and participants will have a brain PET scan. Blood samples will be taken during the PET scan, and urine samples will be taken after the scan. These tests will take up to 3 hours to perform. - Part 2: Participants will have a whole body PET scan that will last a maximum of 3 hours. - Part 3: Participants will receive the study drug and have two additional PET scans. Blood samples will also be taken during this part.","other_id":"100204","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":50,"population":"","criteria":"\n        -  INCLUSION CRITERIA:\r\n\r\n        Healthy Volunteers:\r\n\r\n        Subjects must be adults between 18-50 years old.\r\n\r\n        Subjects must be able and willing to give written informed consent.\r\n\r\n        EXCLUSION CRITERIA:\r\n\r\n        Current psychiatric illness or severe systemic disease based on history and physical exam.\r\n\r\n        If women, pregnancy or breast feeding (betaHCG will be measured in all female patients\r\n        within 24 hours of scan and must be negative)\r\n\r\n        Clinically significant laboratory abnormalities.\r\n\r\n        Serious medical problems including but not limited to chronic neurological disease such as\r\n        multiple sclerosis, autoimmune diseases or any cardiopulmonary disease.\r\n\r\n        Head trauma resulting in a period of unconsciousness lasting longer than 10 minutes.\r\n\r\n        Recent exposure to radiation (i.e., PET from other research) which when combined with this\r\n        study would be above the allowable limits.\r\n\r\n        Positive urine drug screen at screening.\r\n\r\n        Inability to lie flat on camera bed for about 2.5 hours\r\n\r\n        Subjects who have metallic foreign bodies that would be affected by the MRI magnet, or fear\r\n        of enclosed spaces likely to make the subject unable to undergo an MRI scan.\r\n      ","sponsor":"National Institute of Mental Health (NIMH)","sponsor_type":"NIH","conditions":"Pain|Anxiety|Depression","interventions":[{"intervention_type":"Drug","name":"Drug: NOP-1A"}],"outcomes":[{"outcome_type":"primary","measure":"For the PET scans, we will measure the regional densities of NOP receptors as distribution volume (VT). Distribution volume is the ratio at equilibrium of brain uptake to the concentration of parent radioligand in plasma.","time_frame":"2 years"}]}
{"nct_id":"NCT01212250","start_date":"2010-09-01","phase":"N/A","enrollment":132,"brief_title":"Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis","official_title":"A Prospective, Double-blind, Randomized Placebo-controlled Trial of Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis","primary_completion_date":"2020-12-01","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2020-12-01","last_update":"2019-11-05","description":"Patients of cirrhosis aged 18 to 75 years who have no esophageal varices will be enrolled. After baseline evaluation, the participants will be randomized to receive either Placebo or Carvedilol 12.5 mg BD. After randomization they will be followed up for one year.","other_id":"ILBS PHT-003","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients of cirrhosis aged 18 to 75 years who have no esophageal or gastric varices.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any contra-indication to beta-blockers\r\n\r\n          -  Any past EVL or sclerotherapy\r\n\r\n          -  Any past history of surgery for portal hypertension\r\n\r\n          -  Significant cardio or pulmonary co-morbidity\r\n\r\n          -  Any malignancy\r\n\r\n          -  Refusal to participate in the study\r\n      ","sponsor":"Institute of Liver and Biliary Sciences, India","sponsor_type":"Other","conditions":"Cirrhosis","interventions":[{"intervention_type":"Drug","name":"Drug: carvedilol","description":"Carvedilol will be administered orally at a start dose of 3.125 mg twice daily. After 1 week, this will increased if systolic blood pressure does not fall below 90 mm Hg. The patient will receive the maximum tolerated dose of carvedilol with a maximum of 6.25 BD."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"The placebo tablets will be identical to the carvedilol tablets. First the patients will receive placebo in the dose of 1 BD. Then depending on his tolerance it will be increased to a maximum of 2 BD."}],"outcomes":[{"outcome_type":"primary","measure":"the proportions of patients who develop esophageal varices at 1 year in each group.","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Number of patient dying in a period of one year","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Number of patients needing discontinuation of therapy due to adverse effects.","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Reduction in Hepatic Venous Pressure Gradient in both groups","time_frame":"1 year"}]}
{"nct_id":"NCT01163838","start_date":"2010-08-31","phase":"Phase 1","enrollment":0,"brief_title":"Multiple-Dose Safety Study Of RN316 For TheTreatment Of Hypercholesterolemia","official_title":"A Phase 1, Placebo-Controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Multiple Intravenous Doses Of RN316 In Healthy Adult Subjects With Hypercholesterolemia","primary_completion_date":"2011-03-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2011-03-31","last_update":"2015-04-23","description":"The primary objective of this study is to evaluate the safety and tolerability of repeated doses of RN316 in eligible healthy volunteers. RN316 is an investigational drug that is currently being studied as a cholesterol lowering therapy.","other_id":"B1481002","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  LDL-C must be greater or equal to 130 mg/dl\r\n\r\n          -  BMI must be between 18.5 and 40 kg/m2\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of cardiovascular or cerebrovascular event during the past year.\r\n\r\n          -  Poorly controlled type 1 or type 2 diabetes mellitus\r\n\r\n          -  Subjects who have taken lipid lowering therapies within the last 3 months of\r\n             screening.\r\n      ","sponsor":"Pfizer","sponsor_type":"Industry","conditions":"Hypercholesterolemia|Dyslipidemia","interventions":[{"intervention_type":"Biological","name":"Biological: Placebo","description":"Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight."},{"intervention_type":"Biological","name":"Biological: 1 mg/kg every 2 weeks","description":"Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight."},{"intervention_type":"Biological","name":"Biological: 2 mg/kg every 4 weeks","description":"Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight."},{"intervention_type":"Biological","name":"Biological: 4 mg/kg every 4 weeks","description":"Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight."},{"intervention_type":"Biological","name":"Biological: 4 mg/kg every 8 weeks","description":"Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight."},{"intervention_type":"Biological","name":"Biological: 8 mg/kg every 8 weeks","description":"Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight."},{"intervention_type":"Biological","name":"Biological: 12 mg/kg every 8 weeks","description":"Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight."}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of dose limiting or intolerable treatment related adverse events (AEs).","time_frame":"Every Scheduled Visit"},{"outcome_type":"primary","measure":"Incidence, severity and causal relationship of treatment emergent AEs (TEAEs).","time_frame":"Every Scheduled Visit"},{"outcome_type":"primary","measure":"Incidence of abnormal and clinically relevant safety laboratories.","time_frame":"Screening and Days 29, 57, 85, 113, 135, 141, 169 and 197"},{"outcome_type":"primary","measure":"Abnormal and clinically relevant changes in vital signs, BP, and ECG parameters.","time_frame":"Every Scheduled Visit"},{"outcome_type":"primary","measure":"Incidence of anti-drug-antibodies.","time_frame":"Baseline and Day 15 and monthly thereafter"},{"outcome_type":"secondary","measure":"PK parameter estimates including but not be limited to: AUC, Tmax, Cmax terminal elimination half life (t1/2), Clearance (CL), volume of distribution at steady state (Vss), and accumulation ratio (R) of RN316.","time_frame":"Day 1 and every scheduled visit thereafter"},{"outcome_type":"secondary","measure":"Absolute and percentage change in LDL C from baseline.","time_frame":"Every scheduled visit except Day 1"},{"outcome_type":"secondary","measure":"Proportion of subjects who achieve a target LDL C of <100 mg/mL.","time_frame":"Every scheduled visit except Day 1"},{"outcome_type":"secondary","measure":"Proportion of subjects who achieve a target LDL C of <70 mg/dL.","time_frame":"Every scheduled visit except Day 1"},{"outcome_type":"secondary","measure":"Proportion of subjects achieving 50% decrease in LDL C from baseline.","time_frame":"Every scheduled visit except Day 1"}]}
{"nct_id":"NCT01162330","start_date":"2010-08-31","enrollment":411,"brief_title":"The Benefits Feasibility and Acceptability of Extended Screening Testing in Newborn Babies Who Are Referred for Further Hearing Assessment","official_title":"The Benefits Feasibility and Acceptability of Extended Screening Testing in Newborn Babies Who Are Referred for Further Hearing Assessment After Their Neonatal Screen (BEST)","primary_completion_date":"2013-02-28","study_type":"Observational","rec_status":"Completed","completion_date":"2013-02-28","last_update":"2015-10-12","description":"This study will look at the feasibility and acceptability of testing newborn babies who are referred after their newborn hearing screen for an infection called congenital Cytomegalovirus (cCMV). Around 1 in every 100 to 200 babies is born with this virus, and although most remain well it causes 1 in 5 cases of childhood deafness. Knowing that a baby is infected shortly after birth could have significant benefit since a treatment is now available, but screening programs need to be feasible and acceptable. This study aims to evaluate targeted screening for cCMV by taking samples (saliva and urine) from babies who do not pass their newborn hearing screening. The investigators want to see if we can find a quick, reliable and parentally acceptable way to screen babies who fail their hearing test for this virus.","other_id":"5286","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","maximum_age":0.05753,"population":"This population this study examines is infants in Newcastle and South West London who are\r\n        referred for more hearing tests after their neonatal hearing screen.\r\n\r\n        This cohort of patients will be offered screening tests for congenital CMV infection.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  All infants 'referred' for one or both ears following hospital-based newborn hearing\r\n             screening in North of Tyne and South West London areas. Babies with other known causes\r\n             of SNHL (e.g. hereditary) and those admitted to Neonatal Intensive Care Units will be\r\n             included.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Exclusions to this study will be infants with parents/guardians not willing/able to\r\n             give informed consent or children known to have congenital CMV by antenatal testing or\r\n             clinical features of CMV infection at birth.\r\n      ","sponsor":"Newcastle-upon-Tyne Hospitals NHS Trust","sponsor_type":"Other","conditions":"Hearing Loss|Cytomegalovirus","interventions":[{"intervention_type":"Other","name":"Other: Screening urine and saliva tests for congenital Cytomegalovirus","description":"With consent for the study babies who are referred for further hearing tests will have a urine and saliva sample sent to be analysed for CMV infection"}],"outcomes":[{"outcome_type":"primary","measure":"Feasibility of targeted screening for congenital CMV","time_frame":"30 months","description":"Feasibility: as determined by proportion of urine and salivary swabs processed with a result back to parents and health professionals that would allow treatment if needed to be initiated by 28 days of age."},{"outcome_type":"primary","measure":"Acceptability of extended screening tests","time_frame":"30 months","description":"Parental acceptability as determined by anxiety measures (in comparison to published data in parents whose infants are referred for failing their hearing screen, but where no mention of extended screening is made) and parental responses to extended questionnaires about the ease of the process of obtaining samples."},{"outcome_type":"secondary","measure":"Clinical utility of extended screening tests","time_frame":"30 months","description":"Secondary outcomes.\r\nAssess and compare the clinical utility of performing salivary and urine CMV testing on babies referred through NHSP in terms of:\r\nrate of diagnosis of cCMV by day 21\r\nrate of initiation of treatment, where clinically indicated, by 4 weeks of age. 2. Calculate the prevalence of cCMV in children with SNHL detected following newborn hearing screening (number per population screened)"}]}
{"nct_id":"NCT01697189","start_date":"2010-08-31","phase":"N/A","enrollment":54,"brief_title":"An Educational Intervention to Promote Safe Driving","official_title":"An Educational Intervention to Promote Safe and Economic Truck Driving","primary_completion_date":"2012-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-05-31","last_update":"2012-10-02","description":"The general aim of the study is to promote safe, economic, and environmental-friendly driving among long-haul truck drivers. To do this, the investigators will conduct an on-road study on i) the relationship of driver sleepiness and stress with driving behaviour and fuel consumption and ii) effectiveness of an educational intervention in mitigating sleepiness at the wheel. The educational intervention is designed to be employed by occupational health care professionals in the future. This solution clearly facilitates the implementation of the intervention into practice if it turns out to be effective. The investigators specified research questions are the following: - Do truck driver sleepiness and stress at the wheel reach levels that affect driving behaviour, fuel consumption and carbon emissions? - What are the sources of sub-optimal arousal at the wheel in truck drivers? - Can truck driver sleepiness be mitigated by an educational intervention, and if yes, does it improve driving behaviour and decrease fuel consumption and carbon emissions as well?","other_id":"EISD-109378-FWF","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  working as a truck driver at the moment of the study\r\n\r\n          -  having both day and night trips\r\n\r\n          -  having at least 2 years of experience in truck driving\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  not fluent in Finnish (the intervention is in Finnish)\r\n      ","sponsor":"Finnish Institute of Occupational Health","sponsor_type":"Other","conditions":"Driver Sleepiness","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Fatigue management training","description":"Experimental group took part in a single half-day (4 hours) fatigue management training grounded on Problem Based Learning (PBL)."}],"outcomes":[{"outcome_type":"primary","measure":"driver sleepiness","time_frame":"one year","description":"Self-reported sleepiness measured by the the Karolinska Sleepiness Scale Questionnaire and behavioral sleepiness measured by the Observer Rating of Drowsiness (based on video materia)."},{"outcome_type":"secondary","measure":"driver stress","time_frame":"one year","description":"Self-rating scale of stress and heart rate measures of stress (heart rate variability)"},{"outcome_type":"secondary","measure":"sleep","time_frame":"one year","description":"wrist-worn actigraphy and sleep diary based measures of sleep quantity, timing and quality"},{"outcome_type":"secondary","measure":"driving behaviour","time_frame":"one year","description":"vehicle movement-based measures of driving behaviour (speed, accelerations, deceleration)"}]}
{"nct_id":"NCT04804397","start_date":"2010-08-31","phase":"N/A","enrollment":80,"brief_title":"Effects of Sucrose Added Blind to the Diet Over Eight Weeks on Body Mass and Weight in Men","official_title":"Effects of Sucrose Added Blind to the Diet Over Eight Weeks on Body Mass and Weight in Men","primary_completion_date":"2013-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-06-30","last_update":"2021-03-18","description":"Background: Sugar intake, especially in liquid, correlates with obesity. Yet, whether it is a special cause of obesity is less clear. Few experimental studies exist. Aim: To replicate the investigators' previous 4 week experiments on women with men over 8 weeks to ascertain if: they gain weight given sucrose soft drinks; mood is affected; energy intake is affected. Participants: 80 men BMI 25-35, aged 30-55. Procedure: After a week of baseline, over eight weeks single blind 40 men received soft drinks containing sucrose (1650 KJ, 97g carbohydrate per day), 40 received control drinks. A three-day food diary with mood ratings and activity levels was completed during baseline and weeks 1, 4 and 8 of the experiment. Body mass was recorded weekly with other anthropometric measures.","other_id":"PSY4272","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"Single","sampling_method":"","gender":"Male","minimum_age":30,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  BMI 25-35\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Diabetes,\r\n\r\n          -  other health problems,\r\n\r\n          -  medication,\r\n\r\n          -  dislike of soft drinks\r\n      ","sponsor":"University of Hull","sponsor_type":"Other","conditions":"Overweight","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Sucrose","description":"Sucrose sweetened soft drinks"}],"outcomes":[{"outcome_type":"primary","measure":"Body Mass","time_frame":"Eight Weeks","description":"Do participants gain weight?"},{"outcome_type":"secondary","measure":"Daily energy intake assessed by free-living unweighed food diary","time_frame":"Eight Weeks","description":"Do participants eat less to compensate for added sucrose?"},{"outcome_type":"secondary","measure":"Mood assessed using 10 rating scales","time_frame":"Eight Weeks","description":"Are there changes in rated mood during sucrose supplementation?"}]}
{"nct_id":"NCT01255254","start_date":"2010-08-31","phase":"Phase 1","enrollment":40,"brief_title":"The Effect of Oral Hygiene and Full Mouth Scaling on Metabolic Control in Patients With Type II Diabetes","primary_completion_date":"2011-08-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2011-08-31","last_update":"2010-12-07","description":"The aim of the study is to evaluate the effect of non-surgical periodontal therapy, consisting of oral hygiene instruction, full mouth scaling and an antimicrobial rinse on the metabolic control of chronic periodontitis patients with type II diabetes mellitus.","other_id":"RMB 0350-10 CTIL","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":25,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age 25- 75 years;\r\n\r\n          2. Type 2 diabetes;\r\n\r\n          3. Chronic periodontitis with 2 or more teeth with CAL6mm and one site with a PD5mm\r\n             (\"established periodontitis\")16\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Periodontal treatment within the last 3 months\r\n\r\n          2. The use of antibiotics within the last 4 weeks\r\n\r\n          3. Pregnancy or the intention to be pregnant in the next 4 months\r\n      ","sponsor":"Rambam Health Care Campus","sponsor_type":"Other","conditions":"Gingival Scaling|Metabolic Control","interventions":[{"intervention_type":"Procedure","name":"Procedure: Gingival scaling","description":"Oral hygeine instruction and gingival scaling using hand and ultrsonic instruments."}],"outcomes":[{"outcome_type":"primary","measure":"Metabolic control","time_frame":"3 months","description":"Blood sample that measures fasting plasma glucose and the HbA1c level."},{"outcome_type":"secondary","measure":"Inflammation","time_frame":"3 months","description":"Blood sample to measure C reactive protein (inflammatory marker)."}]}
{"nct_id":"NCT01654809","start_date":"2010-08-31","phase":"Phase 4","enrollment":900,"brief_title":"Safety and Immunogenicity Study of Split Influenza Virus Vaccine in Different Age Groups","official_title":"Evaluation of Safety and Immunogenicity Among Different Age-groups Receiving Different Split Influenza Vaccines","primary_completion_date":"2011-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-06-30","last_update":"2012-10-02","description":"The purpose of this study is to observe the adverse reaction ratio and hemagglutination inhibition (HI) antibody positive rate, Geometric mean titer (GMT) of three brands split influenza virus vaccine in different population.","other_id":"BJCDPC-1","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":0.5,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  participants were enrolled (toddlers: 6 months to 3 years; school-aged children: 6 to\r\n             12 years and older adults: 60 years\r\n\r\n          -  Eligible participants were generally healthy or had stable chronic medical conditions\r\n             (for older adults only)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of allergic reaction to any component of the study vaccines or previous\r\n             influenza vaccine\r\n\r\n          -  History of systemic hypersensitivity to hens' eggs\r\n\r\n          -  History of Guillain Barr syndrome following administration of any influenza vaccine\r\n\r\n          -  Any immunodeficient or immunocompromised conditions\r\n\r\n          -  Receipt of cytotoxic or immunosuppressive drugs within the past 6 months\r\n\r\n          -  Receipt of blood-derived product within the past 3 months\r\n\r\n          -  Receipt of any vaccine within one month prior to study entry with exception of\r\n             paediatric routine vaccination\r\n\r\n          -  Receipt of non-study 2010-2011 seasonal TIV\r\n\r\n          -  Participation in any other study with a non-approved drug during the study\r\n\r\n          -  Acute febrile disease and other self-limiting illness were the temporary exclusion\r\n             criteria\r\n      ","sponsor":"Beijing Center for Disease Control and Prevention","sponsor_type":"Other","conditions":"Influenza","interventions":[{"intervention_type":"Biological","name":"Biological: evaluated vaccine","description":"0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)"},{"intervention_type":"Biological","name":"Biological: imported compared vaccine","description":"0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)"},{"intervention_type":"Biological","name":"Biological: domestic compared vaccine","description":"0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)"}],"outcomes":[{"outcome_type":"primary","measure":"To evaluate the immunogenicity of evaluated vaccine","time_frame":"6 months","description":"The immunologic equivalence of 7days after vaccination of influenza virus vaccine was measured in terms of GMTs."},{"outcome_type":"primary","measure":"To evaluate the safety","time_frame":"4 months","description":"The incidence of adverse events was analyzed statistically"}]}
{"nct_id":"NCT01189500","start_date":"2010-08-31","phase":"Phase 4","enrollment":30,"brief_title":"Open-Label Drug Interaction Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) 100mg On The Pharmacokinetics Of Tamoxifen When Coadministered To Healthy Post-Menopausal Female Subjects","official_title":"An Open-Label, 2-Period Sequential Drug Interaction Study To Evaluate The Effect Of A 100 Mg Dose Of Desvenlafaxine SR On The Pharmacokinetics Of Tamoxifen When Co-Administered In Healthy Post-Menopausal Female Subjects","primary_completion_date":"2010-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-10-31","last_update":"2011-11-06","description":"The goal of this study is to evaluate the effect of multiple doses of Desvenlafaxine SR on the pharmacokinetics of Tamoxifen and endoxifen when coadministered to healthy post-menopausal female subjects. This study will also evaluate the safety and tolerability of Desvenlafaxine SR and Tamoxifen when coadministered to healthy post-menopausal female subjects.","other_id":"B2061027","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy post-menopausal female subjects, at least 45 years of age, with confirmed\r\n             post-menopausal status\r\n\r\n          -  Hysterectomized subjects\r\n\r\n          -  Body Mass Index (BMI) less than or equal to 34.0 kg/m2\r\n\r\n          -  Nonsmoker or smoker of fewer than 5 cigarettes per day as determined by history\r\n\r\n          -  An informed consent document signed and dated by the subject\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of significant blood, kidney, endocrine, lung, gastrointestinal, heart, liver,\r\n             psychiatric, neurologic, or allergic disease\r\n\r\n          -  Presence or history of deep vein thrombosis or transient ischemic attack\r\n\r\n          -  History of seizure disorder\r\n\r\n          -  Presence or history of glaucoma or increased intraocular pressure\r\n\r\n          -  Allergy to or unable to tolerate tamoxifen, desvenlafaxine, or venlafaxine\r\n\r\n          -  History of substance abuse within 1 year of study\r\n\r\n          -  A positive urine drug screen\r\n\r\n          -  Treatment with an investigational drug within 30 days\r\n\r\n          -  Consumption of grapefruit or grapefruit related citrus fruits\r\n\r\n          -  12 lead ECG demonstrating QTc >450 msec at screening\r\n\r\n          -  Pregnant or nursing females\r\n\r\n          -  Use of prescription or nonprescription drugs and dietary supplements\r\n\r\n          -  History of sensitivity to heparin or heparin induced thrombocytopenia\r\n\r\n          -  Severe acute or chronic medical or psychiatric condition or laboratory abnormality\r\n\r\n          -  Use of CYP 2D6 inhibitors and CYP 3A4 inhibitors/inducers\r\n      ","sponsor":"Pfizer","sponsor_type":"Industry","conditions":"Pharmacokinetics","interventions":[{"intervention_type":"Drug","name":"Drug: Tamoxifen","description":"Period 1-Tamoxifen 40mg on study day 1."},{"intervention_type":"Drug","name":"Drug: Tamoxifen and Desvenlafaxine Succinate Sustained Release","description":"Period 2-Desvenlafaxine SR 100mg on days 1-28 with coadministration of Tamoxifen 40mg on day 7."}],"outcomes":[{"outcome_type":"primary","measure":"Tamoxifen Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Tamoxifen Alone and When Coadministered With DVS SR","time_frame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.","description":"Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞); measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL)."},{"outcome_type":"primary","measure":"Endoxifen (Metabolite) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Endoxifen Alone and When Coadministered With DVS SR","time_frame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.","description":"Endoxifen is a metabolite of Tamoxifen. Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞)."},{"outcome_type":"secondary","measure":"Tamoxifen Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR","time_frame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.","description":"Cmax measured as nanograms per milliliters (ng/mL)."},{"outcome_type":"secondary","measure":"Tamoxifen Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR","time_frame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.","description":"Time for maximum observed plasma concentration."},{"outcome_type":"secondary","measure":"Tamoxifen Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR","time_frame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.","description":"Terminal half-life is the time measured for the plasma concentration to decrease by one half."},{"outcome_type":"secondary","measure":"Tamoxifen Apparent Clearance (CL/F) Following Tamoxifen Alone and When Coadministered With DVS SR","time_frame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.","description":"Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf); measured as milliliters per minute (mL/min)."},{"outcome_type":"secondary","measure":"Tamoxifen Apparent Volume of Distribution (Vz/F) Following Tamoxifen Alone and When Coadministered With DVS SR","time_frame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.","description":"Calculated as Dose / (AUCinf * kel); where kel=terminal phase rate constant."},{"outcome_type":"secondary","measure":"Endoxifen (Metabolite) Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR","time_frame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29."},{"outcome_type":"secondary","measure":"Endoxifen (Metabolite) Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR","time_frame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.","description":"Time for maximum observed plasma concentration."},{"outcome_type":"secondary","measure":"Endoxifen (Metabolite) Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR","time_frame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.","description":"Terminal half-life is the time measured for the plasma concentration to decrease by one half."},{"outcome_type":"secondary","measure":"Endoxifen (Metabolite) Apparent Clearance (CL/F) Following Tamoxifen Alone and When Coadministered With DVS SR","time_frame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.","description":"Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf); measured as milliliters per minute (mL/min)."},{"outcome_type":"secondary","measure":"Endoxifen (Metabolite) Apparent Volume of Distribution (Vz/F) Following Tamoxifen Alone and When Coadministered With DVS SR","time_frame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29."},{"outcome_type":"secondary","measure":"Plasma N-desmethyl-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR","time_frame":"Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing","description":"Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.250 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0."},{"outcome_type":"secondary","measure":"N-desmethyl-tamoxifen (Metabolite) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Tamoxifen Alone and When Coadministered With DVS SR","time_frame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.","description":"N-desmethyl-tamoxifen is a metabolite of Tamoxifen. Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞)."},{"outcome_type":"secondary","measure":"N-desmethyl-tamoxifen (Metabolite) Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR","time_frame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29."},{"outcome_type":"secondary","measure":"N-desmethyl-tamoxifen (Metabolite) Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR","time_frame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.","description":"Time for maximum observed plasma concentration."},{"outcome_type":"secondary","measure":"N-desmethyl-tamoxifen (Metabolite) Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR","time_frame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.","description":"Terminal half-life is the time measured for the plasma concentration to decrease by one half."},{"outcome_type":"secondary","measure":"N-desmethyl-tamoxifen (Metabolite) Apparent Clearance (CL/F) Following Tamoxifen Alone and When Coadministered With DVS SR","time_frame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.","description":"Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf); measured as milliliters per minute (mL/min)."},{"outcome_type":"secondary","measure":"N-desmethyl-tamoxifen (Metabolite) Apparent Volume of Distribution (Vz/F) Following Tamoxifen Alone and When Coadministered With DVS SR","time_frame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29."},{"outcome_type":"secondary","measure":"4-hydroxy-tamoxifen (Metabolite) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Tamoxifen Alone and When Coadministered With DVS SR","time_frame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.","description":"4-hydroxy-tamoxifen is a metabolite of Tamoxifen. Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞)."},{"outcome_type":"secondary","measure":"4-hydroxy-tamoxifen (Metabolite) Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR","time_frame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29."},{"outcome_type":"secondary","measure":"4-hydroxy-tamoxifen (Metabolite) Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR","time_frame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.","description":"Time for maximum observed plasma concentration."},{"outcome_type":"secondary","measure":"4-hydroxy-tamoxifen (Metabolite) Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR","time_frame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.","description":"Terminal half-life is the time measured for the plasma concentration to decrease by one half."},{"outcome_type":"secondary","measure":"4-hydroxy-tamoxifen (Metabolite) Apparent Clearance (CL/F) Following Tamoxifen Alone and When Coadministered With DVS SR","time_frame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.","description":"Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf); measured as milliliters per minute (mL/min)."},{"outcome_type":"secondary","measure":"4-hydroxy-tamoxifen (Metabolite) Apparent Volume of Distribution (Vz/F) Following Tamoxifen Alone and When Coadministered With DVS SR","time_frame":"Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29."},{"outcome_type":"secondary","measure":"Plasma Tamoxifen Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR","time_frame":"Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing","description":"Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.250 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0."},{"outcome_type":"secondary","measure":"Plasma Endoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR","time_frame":"Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing","description":"Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0."},{"outcome_type":"secondary","measure":"Plasma 4-hydroxy-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR","time_frame":"Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing","description":"Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0."}]}
{"nct_id":"NCT01253850","start_date":"2010-08-31","enrollment":31,"brief_title":"Improving Antiretroviral Medication Adherence Among HIV-infected Youth: Phase I","official_title":"Improving Antiretroviral Medication Adherence Among HIV-infected Youth: Phase I","primary_completion_date":"2011-07-31","study_type":"Observational","rec_status":"Completed","completion_date":"2013-03-06","last_update":"2017-04-17","description":"HIV is increasing among adolescents and young adults in the US. Antiretroviral medications, when taken correctly (90% of prescribed doses taken), can vastly improve life expectancy. However, adherence among HIV-infected young people is suboptimal, and few interventions are available to help adolescents adhere to treatment. The first phase of the study is an intervention development phase, which includes conducting interviews with 40 HIV-infected youth for input on the adaptation of the approach. The information obtained from the qualitative interviews is used to adapt the Life-Steps intervention (designed by our group for HIV-infected adults) to be responsive to the needs of HIV-infected adolescents, with acceptability of topics and content, and feasibility of intervention delivery to be tested in an open pilot trial.","other_id":"CFAR Adherence HIV Youth:1","observational_model":"Cohort","time_perspective":"Other","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":13,"maximum_age":24,"population":"HIV-infected youth between the ages of 13 and 24","criteria":"\n        Phase I\r\n\r\n        Inclusion Criteria:\r\n\r\n          -  Age 13 to 24 years\r\n\r\n          -  HIV-infected and aware of HIV-infection status\r\n\r\n          -  Currently taking antiretroviral therapy, has been prescribed antiretroviral therapy in\r\n             the past 6 months, or a medical provider has recommended antiretroviral medications\r\n             within the last 6 months\r\n\r\n          -  Willing and able to provide informed consent or assent (if under the age of 18)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Not willing or able to provide informed consent or assent (if under the age of 18)\r\n\r\n          -  Is dealing with a severe mental illness requiring immediate treatment (e.g. active\r\n             psychotic episode) or a mental illness that would limit a participant's ability to\r\n             engage with study protocol (e.g. dementia)\r\n\r\n          -  Has severe cognitive limitations that would limit a participant's ability to\r\n             comprehend the informed consent or assent.\r\n\r\n        Phase II\r\n\r\n        Inclusion Criteria:\r\n\r\n          -  Age 13-24 years\r\n\r\n          -  HIV-infected and aware of HIV-infection status\r\n\r\n          -  Currently taking antiretroviral therapy\r\n\r\n          -  Self-reported difficulties adhering to HIV medications in the past 3 months\r\n\r\n          -  Self-identify as heterosexual or LGB\r\n\r\n          -  Willing and able to provide informed consent/consent of parent/guardian if under the\r\n             age of 18\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Not willing or able to provide informed consent or assent (if under the age of 18)\r\n\r\n          -  Is dealing with a severe mental illness requiring immediate treatment (e.g. active\r\n             psychotic episode) or a mental illness that would limit a participant's ability to\r\n             engage with study protocol (e.g. dementia)\r\n\r\n          -  Has severe cognitive limitations that would limit a participant's ability to\r\n             comprehend the informed consent or assent.\r\n      ","sponsor":"Fenway Community Health","sponsor_type":"Other","conditions":"HIV Infection","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"perceived barriers and facilitators to adherence","time_frame":"One-time qualitative interview","description":"We will code the qualitative interview data for key themes that emerge with respect to adherence and intervention needs. The information obtained from the qualitative interviews is used to adapt the Life-Steps intervention (designed by our group for HIV-infected adults) to be responsive to the needs of HIV-infected adolescents, with acceptability of topics and content, and feasibility of intervention delivery to be tested in an open pilot trial."}]}
{"nct_id":"NCT01194258","start_date":"2010-08-31","phase":"Phase 2","enrollment":132,"brief_title":"Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Patients With Type 2 Diabetes Mellitus","official_title":"A Phase II, Randomized, Double Blind, 2-Way Crossover Safety and Efficacy Study of Subcutaneously Injected Prandial Insulins: Lispro-PH20 or Aspart-PH20 Compared to Insulin Lispro (Humalog) in Patients With Type 2 Diabetes","primary_completion_date":"2011-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-08-31","last_update":"2014-08-20","description":"The purpose of the study was to compare Humalog (insulin lispro)-recombinant human hyaluronidase PH20 (rHuPH20) or Novolog (insulin aspart)-rHuPH20 to insulin lispro for the treatment of Type 2 diabetes mellitus (T2DM) in basal-bolus therapy.","other_id":"HALO-117-206","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Males or females 18 years\r\n\r\n          -  Type 2 diabetes mellitus (T2DM) treated with insulin 12 months and prandial insulin\r\n             (at least 2 meals per day) for 2 months\r\n\r\n          -  Body mass index (BMI) of 23.0 to 45.0 kilograms per meter squared (kg/m^2)\r\n\r\n          -  Glycosylated hemoglobin (HbA1C) level 7.0 to 8.5%, inclusive\r\n\r\n          -  Fasting C-peptide <0.6 nanograms per milliliter (ng/mL)\r\n\r\n          -  Willingness to use insulin glargine twice a day as basal insulin for the duration of\r\n             the study\r\n\r\n          -  Willingness to avoid use of an insulin infusion pump or unblinded continuous glucose\r\n             monitoring (CGM) during the study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Known or suspected allergy to any component of any of the study drugs\r\n\r\n          -  Exclusive use of pre-mixed insulins\r\n\r\n          -  Use of pramlintide, exenatide, and/or liraglutide within 30 days of screening\r\n\r\n          -  Use of sulfonylureas within two months of screening\r\n\r\n          -  Use of drugs (such as corticosteroids or antimetabolites) that could interfere with\r\n             the interpretation of study results or are known to cause clinically relevant\r\n             interference with insulin action, glucose utilization, or recovery from hypoglycemia,\r\n             during the study or within 30 days of screening\r\n\r\n          -  Recurrent severe hypoglycemia (more than 2 episodes over the last 6 months) or\r\n             hypoglycemic unawareness, as judged by the investigator\r\n      ","sponsor":"Halozyme Therapeutics","sponsor_type":"Industry","conditions":"Diabetes Mellitus, Type II","interventions":[{"intervention_type":"Drug","name":"Drug: Insulin lispro"},{"intervention_type":"Drug","name":"Drug: Insulin aspart"},{"intervention_type":"Drug","name":"Drug: Recombinant human hyaluronidase PH20"},{"intervention_type":"Drug","name":"Drug: Insulin glulisine"},{"intervention_type":"Drug","name":"Drug: Insulin glargine"}],"outcomes":[{"outcome_type":"primary","measure":"Change From Baseline in Glycosylated Hemoglobin A1C (HbA1C) at the End of Each Treatment Period","time_frame":"Baseline, Week 12 and Week 24","description":"Change in glycosylated hemoglobin A1C (HbA1C) from baseline (Week 0) to end of treatment period (Week 12 and Week 24) is presented. Data are presented by combined treatment group (Lispro-recombinant human hyaluronidase PH20 (PH20) + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin lispro from both groups). Least squares (LS) means were calculated from linear contrasts of mixed effects linear models with treatment (Lispro, Aspart), PH20 (yes, no), and treatment sequence as fixed effects and participant within treatment sequence as a random effect."},{"outcome_type":"secondary","measure":"Mean Daily Insulin Dose as Recorded During 10-Point Glucose Monitoring","time_frame":"Week 10 and Week 22","description":"Mean daily insulin dose as recorded during 10-point glucose monitoring is reported. Blood glucose values were obtained during a total of 3 days during each treatment period (3 days during Week 10 of Treatment Period 1 and 3 days during Week 22 of Treatment Period 2) at the following timepoints: immediately prior to breakfast (fasting), 1 hour (hr) after breakfast, 2 hr after breakfast, immediately prior to lunch, 1 hr after lunch, 2 hr after lunch, immediately prior to dinner, 1 hr after dinner, 2 hr after dinner, and at 03:00. A minimum of 7 determinations were required for each day during the 3 days of 10-point glucose profiles. Prandial insulin doses were also recorded during the 10-point glucose monitoring and the mean daily insulin dose over the 3 days was calculated. Data are presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts)."},{"outcome_type":"secondary","measure":"Percentage of Participants Meeting Glucose Targets at Least 2/3 of the Time","time_frame":"Baseline through Week 24, excluding 10-point glucose monitoring days","description":"Participants were instructed to monitor their blood glucose levels a minimum of 4 times per day on all non-10-point glucose monitoring days. The number of participants meeting 90-minute postprandial plasma glucose (PPG) targets of <140 and <180 milligrams per deciliter (mg/dL) for at least 2/3 of values was recorded during non-10-point glucose monitoring was recorded. The number of participants was recorded, and the percentage of participants meeting glucose targets was calculated by the number of participants with values meeting the specified target at least 2/3 of the time by the total number of participants analyzed, multiplied by 100. Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts)."},{"outcome_type":"secondary","measure":"Rates of Hypoglycemia at the End of Each Treatment Period","time_frame":"Week 12 and Week 24","description":"The rate of hypoglycemia, defined as blood glucose levels ≤70 mg/dL and <56 mg/dL, was calculated based on 4 weeks of observation prior to the end of treatment period (that is, Week 12 and Week 24). Data are presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin lispro from both groups). A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module."},{"outcome_type":"secondary","measure":"Change From Baseline in Body Weight at the End of Each Treatment Period","time_frame":"Baseline, Week 12 and Week 24","description":"Change from baseline in body weight at the end of each treatment period (Week 12 and Week 24) is presented. Data are presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin lispro from both cohorts)."},{"outcome_type":"secondary","measure":"Mean Daily PPG Excursions","time_frame":"Week 10 and Week 22","description":"Participants performed 10-point glucose monitoring for a total of 3 days during each treatment period (3 days during Week 10 of Treatment Period 1 and 3 days during Week 22 of Treatment Period 2). Mean daily PPG excursions during 10-point glucose monitoring for breakfast, lunch, and dinner from Treatment Period 1 or Treatment Period 2 are presented. PPG refers to the change in glucose concentration before to after a meal. Data were collected 1 and 2 hours (hr) after each meal. Data are presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (insulin lispro from both cohorts)."}]}
{"nct_id":"NCT01157117","start_date":"2010-08-31","phase":"Phase 2","enrollment":77,"brief_title":"OIT and Xolair (Omalizumab) in Cow's Milk Allergy","official_title":"Oral Immunotherapy Combined With Humanized Monoclonal Anti-IgE Antibody Xolair (Omalizumab)in the Treatment of Cow's Milk Allergy","primary_completion_date":"2015-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-10-31","last_update":"2020-08-14","description":"Food allergy affects up to 4% of the U.S. population and is most common in young children. Milk allergy is the most common cause of food allergy in infants and young children, and usually develops in the first year of life. There is no treatment for food allergy and the current standard of care for milk-allergic individuals is the avoidance of milk-containing products. Research is underway to identify potential therapeutic strategies to reduce or eliminate the adverse effects experienced by milk-allergic individuals when they consume milk-containing products. Several studies have suggested that milk-allergic children who receive milk protein oral immunotherapy (OIT) may become desensitized to milk, resulting in short term protection against accidental ingestion of milk products. However, these children did not develop \"tolerance,\" which is long term protection even after milk immunotherapy is stopped. A potential strategy to induce tolerance to milk uses milk in combination with Xolair (omalizumab). Xolair consists of anti-IgE molecules that attach to IgE, the major antibody involved in allergic reactions. The goal of this clinical trial is to see whether Xolair in combination with milk protein OIT is safer and more effective than OIT alone in inducing tolerance to milk and milk products. Participants will be administered a double blind, placebo controlled milk challenge at various time points in the study. If desensitization is achieved participants will be tested for tolerance at a certain time point after stopping treatment.","other_id":"DAIT AADCRC-MSSM-01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":7,"maximum_age":35,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subject and/or parent/ legal guardian must be able to understand and provide written\r\n             informed consent\r\n\r\n          -  Written or verbal assent from all study subjects less than 18 years (per site\r\n             Institutional Review Board (IRB) regulations)\r\n\r\n          -  7 to 35 years of age; any gender; any racial and ethnic origin\r\n\r\n          -  No known contraindications to therapy using oral immunotherapy with milk protein or\r\n             Xolair (omalizumab)\r\n\r\n          -  All female subjects of childbearing potential must have a negative pregnancy test upon\r\n             study entry\r\n\r\n          -  All treated females of childbearing potential must agree to use FDA approved methods\r\n             of birth control for the duration of the study\r\n\r\n        Active Treatment Subjects:\r\n\r\n          -  Cow's milk allergy confirmed by a positive double-blind placebo controlled milk\r\n             challenge (DBPCMC) to a dose of less than 2 g of milk protein within the past 6 months\r\n\r\n          -  A skin prick test positive to milk (diameter of wheal >= 3.0 mm) OR detectable serum\r\n             milk specific Immunoglobulin E (IgE) level within the previous 12 months (UniCAP > =\r\n             0.35 kUA/L (allergen-equivalent kilounits per liter))\r\n\r\n        Control Subjects:\r\n\r\n         A skin prick test positive to milk (diameter of wheal >= 10.0 mm) OR detectable serum\r\n        milk specific IgE level within the previous 12 months (UniCAP >= 15 kUA/L)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  A history of life-threatening anaphylaxis to milk (involving hypotension or requiring\r\n             mechanical ventilation)\r\n\r\n          -  Known allergy to any components of the placebo for Xolair\r\n\r\n          -  Chronic disease other than asthma, atopic dermatitis, or allergic rhinitis requiring\r\n             therapy (e.g., heart disease, diabetes)\r\n\r\n          -  Use of -blockers (oral), angiotensin-converting enzyme (ACE) inhibitors,\r\n             angiotensin-receptor blockers (ARB), or calcium channel blockers\r\n\r\n          -  Severe asthma\r\n\r\n          -  Mild or moderate asthma with any of the following criteria met:\r\n\r\n               -  Forced expiratory volume in the first second (FEV1) < 80% with or without\r\n                  controller medications\r\n\r\n               -  Inhaled corticosteroids (ICS) dosing of >500 mcg daily fluticasone (or equivalent\r\n                  inhaled corticosteroids based on NHLBI dosing chart)\r\n\r\n               -  history of daily oral steroid dosing for >1 month during the past year\r\n\r\n               -  burst oral steroid course in the past 6 months\r\n\r\n               -  more than one burst oral steroid course in the past year\r\n\r\n               -  more than one hospitalization in the past year for asthma, or\r\n\r\n               -  more than one ER visit in the past 6 months for asthma\r\n\r\n          -  Baseline spirometry (or peak flow rate (PFR) if unable to perform spirometry) result\r\n             of FEV1<80%\r\n\r\n          -  Pregnancy or lactation. All females of child-bearing age will undergo pregnancy\r\n             testing. All treated females will confirm compliance to appropriate birth control\r\n             measures throughout the course of the study;\r\n\r\n          -  Participation in any interventional study for the treatment of food allergy in the\r\n             past 6 months\r\n\r\n          -  Subject is on a buildup phase of standard subcutaneous immunotherapy for inhalant\r\n             allergens (may be enrolled on maintenance dose);\r\n\r\n          -  Use of Xolair (omalizumab) or other non-traditional forms of allergen immunotherapy\r\n             (e.g., oral or sublingual immunotherapy) or immunomodulator therapy (not including\r\n             corticosteroids) or biologic therapy within the past year\r\n\r\n          -  Inability to discontinue antihistamines for 5 half-lives prior to routine study tests\r\n             (DBPCMC or endpoint titration tests)\r\n\r\n          -  Known sensitivity to Xolair (omalizumab) or to the class of study drugs\r\n\r\n          -  Baseline serum total IgE over 1,300 IU/mL or body weight more than 150 kg, or subjects\r\n             with weight-IgE combination that yields a dose requirement greater than 750 mg (due to\r\n             limitations of Xolair (omalizumab) dosing)\r\n\r\n          -  Mental illness or history of drug or alcohol abuse that, in the opinion of the\r\n             investigator, would interfere with the subject's ability to comply with study\r\n             requirements\r\n\r\n          -  Inability or unwillingness of a subject to give written informed consent or comply\r\n             with study protocol\r\n\r\n          -  Use of investigational drugs within 90 days of participation\r\n\r\n          -  Other contraindications to milk oral immunotherapy or Xolair (omalizumab)\r\n\r\n          -  Recipient of any licensed or investigational live attenuated vaccine(s) within 2\r\n             months of enrollment\r\n\r\n          -  Families who do not speak English\r\n\r\n          -  Systemic steroids oral, intramuscular (IM), or IV for indications other than asthma\r\n             for greater than 3 weeks in the past 6 months\r\n      ","sponsor":"Hugh A Sampson, MD","sponsor_type":"Other","conditions":"Milk Allergy","interventions":[{"intervention_type":"Biological","name":"Biological: Placebo for omalizumab","description":"Placebo for omalizumab is injected subcutaneously every 2-4 weeks for 16 months at a volume designed to match that of the verum treatment group (determined by the participant's IgE level and weight)."},{"intervention_type":"Biological","name":"Biological: Omalizumab","description":"Omalizumab is injected subcutaneously every 2-4 weeks for 28 months at a dose determined by the participants IgE level and weight."},{"intervention_type":"Drug","name":"Drug: Milk powder","description":"Milk powder is ingested orally at a dosage of up to 3.84 grams of of milk protein daily from Month 4 through Month 28 if the Month 28 10 g milk OFC is failed, and through Month 30 if the Month 28 10 g milk OFC is passed."}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of Subjects in the Xolair® (Omalizumab) Group vs. Placebo Group Developing Clinical Tolerance to Milk","time_frame":"Month 32 which is 8 weeks following the discontinuation of milk OIT for both groups and 4 months after discontinuation of omalizumab for the omalizumab group","description":"Tolerance Assessment: Participants who successfully consumed without dose-limiting symptoms 10,000 mg of milk protein during a double-blind placebo-controlled oral food challenge were then given an open feeding of milk and those who successfully consumed the open feeding were counted as successes."},{"outcome_type":"secondary","measure":"Incidence of Dosing Reactions to Milk OIT During the Escalation Phase","time_frame":"Baseline to completion of Escalation Phase at 22 to 40 weeks","description":"Any reaction to daily milk OIT dosing recorded by the participant during the Escalation Phase."},{"outcome_type":"secondary","measure":"Incidence of Dosing Reactions to Milk OIT During the Maintenance Phase","time_frame":"After completion of Escalation Phase at 22 to 40 weeks, the Maintenance Phase lasted up to Month 30","description":"Any reaction to daily milk OIT dosing recorded by the participant during the Maintenance Phase."},{"outcome_type":"secondary","measure":"Incidence of Severe Hypersensitivity Reactions to Milk OIT","time_frame":"Through completion of milk OIT dosing (at Month 28 if failed desensitization OFC, at Month 30 if passed desensitization OFC)","description":"Participants who had a change in mental status or hypotension as a milk OIT dosing symptom were counted as having a severe hypersensitivity reaction."},{"outcome_type":"secondary","measure":"Maximum Tolerated Dose of Milk Oral Immunotherapy (OIT)","time_frame":"Baseline to completion of Escalation Phase at 22 to 40 weeks","description":"Maximum tolerated dose of milk OIT is the highest dose of milk powder the participant was able to consume for at least 14 consecutive days."},{"outcome_type":"secondary","measure":"Percentage of Participants in the Xolair® (Omalizumab) Group vs. Placebo Group Developing Desensitization to Milk","time_frame":"Month 28","description":"Desensitization Assessment: Participants who successfully consumed without dose-limiting symptoms 10,000 mg of milk protein during a double-blind placebo-controlled oral food challenge were counted as successes."},{"outcome_type":"secondary","measure":"Time to Maximum Tolerated Dose","time_frame":"Baseline to completion of Escalation Phase at 22 to 40 weeks","description":"Time to reach the maximum tolerated dose (MTD) of milk oral immunotherapy (OIT); MTD is the highest dose of milk powder the participant was able to consume for at least 14 consecutive days."},{"outcome_type":"secondary","measure":"Change From Baseline to Month 32 in Area Under the Curve for Milk Endpoint Titration Prick Skin Test","time_frame":"Month 32","description":"A milk endpoint titration is a prick skin test using 5 serial 10-fold dilutions of milk which include 1:20 wt/vol, 1:200 wt/vol, 1:2,000 wt/vol, 1:20,000 wt/vol and 1:200,000 wt/vol. The score for each of these dilutions is calculated by subtracting the diameter of the saline control wheal from the diameter of the milk wheal (in millimeters). The area under the curve is calculated by adding together the scores from all 5 milk dilutions creating a composite score."},{"outcome_type":"secondary","measure":"Change From Baseline to Month 32 in Antigen-specific Immunoglobulin E (IgE)","time_frame":"Month 32","description":"The level of milk IgE in plasma as well as the IgE levels of 2 milk proteins, casein and beta-lactoglobulin, were measured. The value for each participant was subtracted from the value for that participant at baseline. Month 32 was the last visit on treatment."},{"outcome_type":"secondary","measure":"Change From Baseline to Month 32 in Antigen-specific Immunoglobulin G4 (IgG4)","time_frame":"Month 32","description":"Casein and beta-lactoglobulin milk proteins IgG4 levels were measured in plasma. The value for each participant was subtracted from the value for that participant at baseline. Month 32 was the last visit on treatment."},{"outcome_type":"secondary","measure":"Change From Baseline to Month 38 in Antigen-specific Immunoglobulin E (IgE)","time_frame":"Month 38","description":"The level of milk IgE in plasma as well as the IgE levels of 2 milk proteins, casein and beta-lactoglobulin, were measured. The value for each participant was subtracted from the value for that participant at baseline. Month 38 was 6 months after treatment ended at Month 32."},{"outcome_type":"secondary","measure":"Change From Baseline to Month 38 in Antigen-specific Immunoglobulin G4 (IgG4)","time_frame":"Month 38","description":"Casein and beta-lactoglobulin milk proteins IgG4 levels were measured in plasma. The value for each participant was subtracted from the value for that participant at baseline. Month 38 was 6 months after treatment ended at Month 32."},{"outcome_type":"secondary","measure":"Change in Percent of Cells Positive for Cluster of Differentiation 63 (CD63) at Month 32 in Basophils Stimulated by Milk","time_frame":"Month 32","description":"Basophil cells isolated from blood using flow cytometry were stimulated with 5 different levels of milk and the percent of basophil cells that were CD63 positive was measured. The value for each participant obtained at Month 32 was subtracted from the value for that participant at baseline. The 5 different levels of milk stimulant were: 10 µg/mL, 1 µg/mL , 0.1 µg/mL , 0.01 µg/mL , and 0.001 µg/mL. Month 32 was the last visit on treatment."},{"outcome_type":"secondary","measure":"Change in Percent of Cells Positive for Cluster of Differentiation 63 (CD63) at Month 38 in Basophils Stimulated by Milk","time_frame":"Month 38","description":"Basophil cells isolated from blood using flow cytometry were stimulated with 5 different levels of milk and the percent of basophil cells that were CD63 positive was measured. The value for each participant obtained at Month 38 was subtracted from the value for that participant at baseline. The 5 different levels of milk stimulant were: 10 µg/mL, 1 µg/mL , 0.1 µg/mL , 0.01 µg/mL , and 0.001 µg/mL. Month 38 was 6 months after treatment ended at Month 32."}]}
{"nct_id":"NCT01510223","start_date":"2010-08-31","phase":"N/A","enrollment":24,"brief_title":"The Effect of Macronutrients in the Diet on Digestive and Cardiovascular Health","official_title":"Effect of a 5-day Adaptation and Deadaptation Periods to a High-fat Diet Supplemented With Specific Fatty Acids on Gastrointestinal Transit, Appetite and Substrate Utilisation","primary_completion_date":"2011-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-07-31","last_update":"2012-01-16","description":"This study examined the effect of a 5-day HFD supplemented with specific fatty acids on gastrointestinal transit, appetite, food intake and substrate utilization. Another novel aspect of this chapter was examining whether a subsequent 5-day period was sufficient to reverse the effects of high-fat feeding on the aforementioned parameters.","other_id":"NutrientGastEmpt","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":35,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy adults aged 18-35 years\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of gastrointestinal-related conditions or gastrointestinal disturbance within\r\n             3 months of study entry\r\n\r\n          -  diabetes mellitus\r\n\r\n          -  cardiovascular disease\r\n\r\n          -  Allergies to foods in study\r\n\r\n          -  Pregnancy\r\n      ","sponsor":"University of Limerick","sponsor_type":"Other","conditions":"Obesity|Diabetes|Cardiovascular Diseases","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Olive oil","description":"Each volunteer will complete three test trials. The first (CONTROL) and second test trials (HF) were separated by 28 days. The third trial (LF) takes place on the 6th day following the second trial (5 days apart).\r\nThe CON and LF milkshake supplements are identical (272 kcal; 6 g fat). The basic control (CON) or LF milkshake (that the oil was added to) was: 275 g semi skimmed milk, 25 g chocolate milkshake mix, 15 g dried skimmed milk, 1 g xanthan gum. This was made up to 580 ml with still water.\r\nHigh-fat milkshake supplements were consumed daily for five days before a test trial. 90 g olive oil added to the supplement for the purpose of the HF intervention phase."},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Olive oil and fish powder","description":"Each volunteer will complete three test trials. The first (CONTROL) and second test trials (HF) were separated by 28 days. The third trial (LF) takes place on the 6th day following the second trial (5 days apart).\r\nThe CON and LF milkshake supplements are identical (272 kcal; 6 g fat). The basic control (CON) or LF milkshake (that the oil was added to) was: 275 g semi skimmed milk, 25 g chocolate milkshake mix, 15 g dried skimmed milk, 1 g xanthan gum. This was made up to 580 ml with still water.\r\nHigh-fat milkshake supplements were consumed daily for five days before a test trial. 86.67 g olive oil and 3.3 g of n-3 fish powder (500 mg EPA+DHA)added to the supplement for the purpose of the HF intervention phase."},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Olive oil and macadamia oil","description":"Each volunteer will complete three test trials. The first (CONTROL) and second test trials (HF) were separated by 28 days. The third trial (LF) takes place on the 6th day following the second trial (5 days apart).\r\nThe CON and LF milkshake supplements are identical (272 kcal; 6 g fat). The basic control (CON) or LF milkshake (that the oil was added to) was: 275 g semi skimmed milk, 25 g chocolate milkshake mix, 15 g dried skimmed milk, 1 g xanthan gum. This was made up to 580 ml with still water.\r\nHigh-fat milkshake supplements were consumed daily for five days before a test trial. 74.82 g olive oil and 15.18 g macadamia nut oil added to the supplement for the purpose of the HF intervention phase."},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Deadaptation","description":"A period of 5 days supplementation with the low-fat milkshake represents a de-adaptation period from high-fat intervention."}],"outcomes":[{"outcome_type":"primary","measure":"Gastric emptying by 13C octanoic acid breath test","time_frame":"within the first 6.5 hours after ingesting high-fat test meal","description":"13CO2 breath samples were taken every 15 minutes for six hours. Breath samples for measurement of 13CO2 were analyzed using isotope ratio mass spectrometry and results were expressed relative to Vienna-PeeDee Belemnite. 13CO2 values were expressed as the excess amount in the breath above baseline and converted into moles. This was then fitted to a GE model developed by Ghoos et al. 1993. For all the data, r2 coefficient between the modeled and raw data was calculated and r2 > 0.95. Latency phase (Tlat) and ascension time (Tasc) from Schommartz et al. 1998."},{"outcome_type":"secondary","measure":"Appetite","time_frame":"Within the first 6.5 hours after a meal","description":"Satiety was measured using a 150mm VAS to detect changes in hunger, thirst, desire to eat, tiredness, fullness and cold. Variables thirst, tiredness and cold were used to distract volunteers from analysis of their satiety status. This was taken before breakfast, after breakfast, every 30 minutes throughout the six hours and following the buffet meal."},{"outcome_type":"secondary","measure":"substrate utilization","time_frame":"Within the first 6.5 hours after a meal","description":"The Douglas Bag technique was employed to collect expired air samples. VO2 and VCO2 were used to calculate substarte oxidation by satndard indirect calorimetry methods."},{"outcome_type":"secondary","measure":"Food intake by buffet meal","time_frame":"Within 6.5 hours after a meal","description":"After six hours volunteers were given access to a buffet meal and instructed to eat ad libitum. The buffet meal consisted of a 21 different types of foods and contained a wide variety of foods of varying macronutrient. Foods were covertly weighed before and after presentation and the difference converted to macronutrient intake using food tables or manufacturers' data."}]}
{"nct_id":"NCT01573988","start_date":"2010-08-31","phase":"N/A","enrollment":37,"brief_title":"Satiety, Meal Frequency and Nutritional Aspects","official_title":"Behavioural and Metabolic Consequences of Increasing Eating Frequency","primary_completion_date":"2012-04-30","study_type":"Interventional","rec_status":"Terminated","completion_date":"2012-04-30","last_update":"2012-09-27","description":"In this study, the investigators are interested in assessing the effects of the isocaloric increase of eating frequency on appetite and metabolism. How the consumption of an isocaloric breakfast in four intakes vs. one can modify satiety and appetite control in lean and obese subjects through : - the physiological consequences : difference in postprandial kinetics of glucose, non esterified fatty acid, triglyceride, the secretion of satiety gut hormone (insulin, ghrelin, leptin and cholescystokinine (CCK), peptide YY (PYY), glucagon-like peptide-1 (GLP-1), nutrients oxidative fate and plasmatic oxidative stress (Malondialdehyde (MDA), glutathion, lipid hydroperoxides) - eating behavior during an ad libitum buffet test meal","other_id":"2010.612/16","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":20,"maximum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  No smokers\r\n\r\n          -  BMI 20 to 35 kg/m2\r\n\r\n          -  Moderate physical activity\r\n\r\n          -  Safety during medical consultation\r\n\r\n          -  Feeding behavioural phenotype (Dutch Eating Questionnaire, Three Eating Factor\r\n             Questionnaire)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Medical history which may affect glucose metabolism (diabetes, renal or hepatic\r\n             failure, thyroid dysfunction, Cushing syndrome, acromegaly)\r\n\r\n          -  Medical history which affect nutrient absorption (gastro-intestinal and pancreatic\r\n             disease, gastrectomy, colectomy)\r\n\r\n          -  Drug use in the last two months that could affect glucose metabolism (steroids,\r\n             topical gastric preparation, anorectic drugs)\r\n\r\n          -  Eating disorders\r\n\r\n          -  Claustrophobic subjects\r\n      ","sponsor":"Hospices Civils de Lyon","sponsor_type":"Other","conditions":"Volunteers","interventions":[{"intervention_type":"Other","name":"Other: Increasing eating frequency","description":"The subjects receive the same breakfast with two sequences :\r\nbreakfast in one intake at 8:00\r\nbreakfast in four isocaloric intakes (8:00, 9:00, 10:00, 11:00) The sequence made twice : one for metabolic study and one for the study of eating behavior\r\nThe lunch during metabolic study is a standard meal The lunch during behavioural study is an ad libitum buffet test meal.\r\nThe administration order is determined by randomized allocation. The wash-out period is one to three weeks.\r\nThere are not diet or exercise interventions."}],"outcomes":[{"outcome_type":"primary","measure":"Ghrelin plasmatic concentration","time_frame":"240 minutes after breakfast beginning (just before the lunch)"},{"outcome_type":"secondary","measure":"Satiety through food intakes (quantitative) at the ad libitum buffet test meal","time_frame":"Since the beginning of the buffet test meal (240 minutes after breakfast beginning) to the end of the meal (at the latest 270 minutes after breakfast beginning)."},{"outcome_type":"secondary","measure":"Satiety through visual analogue scale","time_frame":"240 minutes after breakfast beginning (just before the lunch)"},{"outcome_type":"secondary","measure":"Plasma metabolite concentrations (glycaemia, non esterified fatty acid,","time_frame":"kinetics during 430 minutes"},{"outcome_type":"secondary","measure":"Endocrine concentrations (insulin, ghrelin, GLP-1, PYY, leptin, C-peptide)","time_frame":"kinetics during 430 minutes"},{"outcome_type":"secondary","measure":"Plasma markers of oxidative stress (MDA, gluthation, lipid hydroxide)","time_frame":"kinetics during 430 minutes"},{"outcome_type":"secondary","measure":"Lipid oxidation","time_frame":"kinetics during 430 minutes"},{"outcome_type":"secondary","measure":"Eating behaviour at the buffet test meal by video recording (food choice, nutritional composition of the meal , kinetics of nutrient intake, meal structure, lunch duration)","time_frame":"during the buffet test meal (max : 30 minutes)"}]}
{"nct_id":"NCT01266473","start_date":"2010-08-31","phase":"N/A","enrollment":6,"brief_title":"Study of Individualized Physiotherapy for Airway Clearance in Cystic Fibrosis.","official_title":"Efficacy Study of Physiotherapy for Airway Clearance in Cystic Fibrosis. Randomized Controlled Trials in Single Subjects (N of 1 RCT's).","primary_completion_date":"2011-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-04-30","last_update":"2013-01-11","description":"The purpose of this study is to investigate individual efficacy in Physiotherapy for Airway Clearance, and to investigate user experience, i.e.utility value and preference.","other_id":"2010/802","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosis: CF\r\n\r\n          -  Age >18 years\r\n\r\n          -  Amount of sputum >5 ml/60 min\r\n\r\n          -  Wet inhalation of saline/DNase/both\r\n\r\n          -  Informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Respiratory failure\r\n\r\n          -  Hemoptysis\r\n\r\n          -  Bacteriology (burkholderia cephacia, multi-resistent pseudomonas aeruginosa, atypical\r\n             mycobacteria, MRSA).\r\n\r\n          -  Ongoing intravenous medication\r\n\r\n          -  Pregnancy\r\n      ","sponsor":"Oslo University Hospital","sponsor_type":"Other","conditions":"Cystic Fibrosis","interventions":[{"intervention_type":"Other","name":"Other: Physiotherapy","description":"Physiotherapy for Airway Clearance"}],"outcomes":[{"outcome_type":"other","measure":"Physiological measurements","time_frame":"8 weeks","description":"Oxygen saturation and heart rate measurements in the beginning and at the end of each intervention.\r\nPulmonary function tests (week 2): measurements before and after each intervention with spirometry."},{"outcome_type":"primary","measure":"Expectorated sputum (gram)","time_frame":"8 weeks","description":"Total amount of expectorated sputum (g) will be collected and weighed wet after each intervention for eight weeks, using a Mettler TOLEDO Weighing Balance (EL 202, accuracy: 0.01 g).\r\nN of 1 trial design. Each trial consist of eight pairs (8 weeks) of treatment periods with two interventions each week (one with Cough Technique and one with Forced Expiration technique), 16 treatments for each participant. Outcome measure after each treatment."},{"outcome_type":"secondary","measure":"Patient's experience, i.e. perceived utility value and preference of technique.","time_frame":"8 weeks","description":"Utility value: Measured by self-reported questionnaire after completion of each intervention in week 8.\r\nPreference: Measured by three self-reported questions after both interventions in week 8."},{"outcome_type":"other","measure":"Health related quality of life (HRQOL)","time_frame":"8 weeks","description":"HRQOL measured by the Cystic Fibrosis Questionnaire Revised (CFQR-R), i.e. respiratory symptoms, in the beginning and at completion of the study."}]}
{"nct_id":"NCT01171989","start_date":"2010-08-18","phase":"Phase 2","enrollment":391,"brief_title":"Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine Administered as a Booster Dose","official_title":"Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine Administered as a Booster Dose in 12-18 Months Old Healthy Children","primary_completion_date":"2010-12-03","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-12-03","last_update":"2020-01-21","description":"The current trial will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine when administered as a booster dose following priming in the first year of life with the same vaccine. This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00970307).","other_id":"113978","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":1,"maximum_age":1.5,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subjects who the investigator believes that parent(s)/ legally acceptable\r\n             representative(s) can and will comply with the requirements of the protocol.\r\n\r\n          -  Subjects who have completed the full three-dose primary vaccination course according\r\n             to their group allocation in the primary study DTPa-HBV-IPV=Hib-MenC-TT-002 (112157).\r\n\r\n          -  A male or female between, and including, 12 and 18 months of age at the time of\r\n             booster vaccination.\r\n\r\n          -  Written informed consent obtained from the parent(s)/ legally acceptable\r\n             representative(s) of the subject.\r\n\r\n          -  Healthy subjects as established by medical history and clinical examination before\r\n             entering into the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Child in care.\r\n\r\n          -  Use of any investigational or non-registered product other than the study vaccines\r\n             within 30 days preceding the dose of study vaccine, or planned use during the study\r\n             period.\r\n\r\n          -  Chronic administration of immunosuppressants or other immune-modifying drugs within\r\n             six months prior to the booster vaccination.\r\n\r\n          -  Planned administration/administration of immunoglobulins and/or any blood products\r\n             within three months before the booster dose, or during the study period.\r\n\r\n          -  Planned administration/administration of any vaccine not foreseen by the study\r\n             protocol during the period starting 30 days before and ending 30 days after the\r\n             booster dose.\r\n\r\n          -  Participation in another clinical study since the primary study\r\n             DTPa-HBV-IPV/Hib-MenC-TT-002 in which the subject has been or will be exposed to an\r\n             investigational or a non-investigational product.\r\n\r\n          -  Evidence of previous diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib,\r\n             pneumococcal and MenC vaccination or disease since the conclusion visit of study\r\n             DTPa-HBV-IPV/Hib-MenC-TT-002.\r\n\r\n          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on\r\n             medical history and physical examination.\r\n\r\n          -  History of any reaction or hypersensitivity likely to be exacerbated by any component\r\n             of the vaccines.\r\n\r\n          -  The following adverse event having occurred after previous administration of DTP\r\n             vaccine:\r\n\r\n               -  Encephalopathy.\r\n\r\n               -  Temperature of >= 40.5C (rectal temperature) within 48 hours of vaccination, not\r\n                  due to another identifiable cause.\r\n\r\n               -  Collapse or shock-like state within 48 hours of vaccination.\r\n\r\n               -  Persistent, inconsolable crying occurring within 48 hours of vaccination and\r\n                  lasting >= 3 hours.\r\n\r\n               -  Seizures with or without fever occurring within 3 days of vaccination.\r\n\r\n        The following condition is temporary or self-limiting, and a subject may be vaccinated once\r\n        the condition has resolved if no other exclusion criteria is met:\r\n\r\n         Acute disease and/or fever at the time of enrolment.\r\n\r\n          -  Fever is defined as temperature  37.5C on oral, axillary or tympanic setting, or \r\n             38.0C on rectal setting.\r\n\r\n          -  Subjects with a minor illness without fever may be enrolled at the discretion of the\r\n             investigator.\r\n      ","sponsor":"GlaxoSmithKline","sponsor_type":"Industry","conditions":"Tetanus|Diphtheria|Haemophilus Influenzae Type b|Hepatitis B|Poliomyelitis|Acellular Pertussis|Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b-Neisseria Meni","interventions":[{"intervention_type":"Biological","name":"Biological: GSK2202083A vaccine","description":"Intramuscular, one dose."},{"intervention_type":"Biological","name":"Biological: Infanrix hexa","description":"Intramuscular, one dose."},{"intervention_type":"Biological","name":"Biological: Menjugate","description":"Intramuscular, one dose."},{"intervention_type":"Biological","name":"Biological: NeisVac-C","description":"Intramuscular, one dose."},{"intervention_type":"Biological","name":"Biological: Synflorix","description":"Intramuscular, one dose."}],"outcomes":[{"outcome_type":"secondary","measure":"Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations","time_frame":"At Month 0 and Month 1, before and one month after booster dose","description":"Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value ≥ 5 EL.U/mL."},{"outcome_type":"primary","measure":"Number of Seroprotected Subjects Against Polyribosyl-Ribitol-Phosphate (PRP)","time_frame":"At Month 1, post-booster dose","description":"A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (μg/mL)."},{"outcome_type":"primary","measure":"Number of Seroprotected Subjects Against Neisseria Meningitidis Serogroup C Using Baby Rabbit Completent (rSBA-MenC)","time_frame":"At Month 1, post-booster dose","description":"A seroprotected subject was defined as a subject with anti-rSBA-MenC titers greater than or equal to (≥) 1:8."},{"outcome_type":"secondary","measure":"Number of Seropositive Subjects for Anti-PRP","time_frame":"At Month 0, before the booster dose","description":"A seropositive subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 μg/mL."},{"outcome_type":"secondary","measure":"Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off","time_frame":"At Month 0 and Month 1, before and one month after booster dose","description":"The cut-off value of the assay was an anti-PRP antibody concentration ≥ 1 μg/mL."},{"outcome_type":"secondary","measure":"Anti-PRP Antibody Concentrations","time_frame":"At Month 0 and Month 1, before and one month after booster dose","description":"Concentrations were expressed as geometric mean concentrations (GMCs) for the cut-off value of ≥ 0.15 μg/mL."},{"outcome_type":"secondary","measure":"Number of Seroprotected Subjects Against rSBA-MenC","time_frame":"At Month 0, before the booster dose","description":"A seroprotected subject was defined as a subject with anti-rSBA-MenC antibody titers ≥ 1:8."},{"outcome_type":"secondary","measure":"Number of Seropositive Subjects for Anti-rSBA-MenC","time_frame":"At Month 0 and Month 1, before and one month after booster dose","description":"A seropositive subject for anti-rSBA-MenC was defined as a subject with antibody titers greater than or equal to (≥) 1:128."},{"outcome_type":"secondary","measure":"Anti-rSBA-MenC Antibody Titres","time_frame":"At Month 0 and Month 1, before and one month after booster dose","description":"Antibody titers were expressed as geometric mean titers (GMTs) for the seroprotection cut-off value of ≥ 1:8."},{"outcome_type":"secondary","measure":"Number of Subjects With Polysaccharide N. Meningitidis Serogroup C (PSC) Antibody Concentrations ≥ Cut-off Values","time_frame":"At Month 0 and Month 1, before and one month after booster dose","description":"The cut-off values assessed were ≥ 0.3 μg/mL and ≥ 2 μg/mL."},{"outcome_type":"secondary","measure":"Anti-PSC Antibody Concentrations","time_frame":"At Month 0 and Month 1, before and one month after booster dose","description":"Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.3 μg/mL."},{"outcome_type":"secondary","measure":"Number of Seropositive Subjects for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T)","time_frame":"At Month 0 and Month 1, before and one month after booster dose","description":"A seropositive subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL)."},{"outcome_type":"secondary","measure":"Anti-D and Anti-T Antibody Concentrations","time_frame":"At Month 0 and Month 1, before and one month after booster dose","description":"Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.1 IU/mL."},{"outcome_type":"secondary","measure":"Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Cut-off Values","time_frame":"At Month 0 and Month 1, before and one month after booster dose","description":"The cut-off values assessed were 3.3 milli-international units per milliliter (mIU/mL), 10 mIU/mL and 100 mIU/mL."},{"outcome_type":"secondary","measure":"Anti-HBs Antibody Concentrations","time_frame":"At Month 0 and Month 1, before and after booster dose","description":"Concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL."},{"outcome_type":"secondary","measure":"Number of Seropositive Subjects for Anti-poliovirus Types 1, 2 and 3","time_frame":"At Month 0 and Month 1, before and one month after booster dose","description":"A seropositive subject was defined as a subject with anti-polio type 1, 2 or 3 ≥ 1:8."},{"outcome_type":"secondary","measure":"Anti-poliovirus Types 1, 2 and 3 Antibody Titres","time_frame":"At Month 0 and Month 1, before and one month after booster dose","description":"Titers were expressed as geometric mean titters (GMTs) for the seropositivity cut-off value of ≥ 1:8."},{"outcome_type":"secondary","measure":"Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)","time_frame":"At Month 0 and Month 1, before and one month after booster dose","description":"A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL)."},{"outcome_type":"secondary","measure":"Number of Subjects With Any Solicited Local Symptoms","time_frame":"During the 8-day (Days 0-7) post-booster period","description":"Solicited local symptoms assessed included pain, redness and swelling. Any= all reports of the speecified symptom irrespective of intensity grade."},{"outcome_type":"secondary","measure":"Number of Subjects With Any Solicited General Symptoms","time_frame":"During the 8-day (Days 0-7) post-booster period","description":"Solicited general symptoms assessed included drowsiness, irritability, loss of appetite and fever (defined as axillary temperature ≥ 37.5º C). Any= all reports of the specified symptom irrespective of intensity grade and relationship to vaccination."},{"outcome_type":"secondary","measure":"Number of Subjects With Unsolicited Adverse Events (AEs)","time_frame":"During the 31-day (Days 0-30) post-booster period","description":"An unsolicited AE was any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms."},{"outcome_type":"secondary","measure":"Number of Subjects With Serious Adverse Events (SAEs)","time_frame":"After the booster dose of the study vaccine up to the study end (from Month 0 to Month 1)","description":"SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity."}]}
{"nct_id":"NCT03553160","start_date":"2010-08-16","phase":"N/A","enrollment":15,"brief_title":"Caloric Titration Method of Weight Loss and Maintenance","official_title":"Caloric Titration Method of Weight Loss and Maintenance in the Cornell Community: A Longitudinal Analysis of Psychological Factors","primary_completion_date":"2012-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-09-01","last_update":"2018-06-12","description":"Study examined the effectiveness of daily self-weighing to prevent age related weight gain.","other_id":"1007001556","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  over the age of 18\r\n\r\n          -  not pregnant\r\n\r\n          -  not trying to gain or lose weight\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  diabetes\r\n\r\n          -  history of an eating disorder\r\n\r\n          -  Body Mass Index (BMI) greater than 27.0 kg/m2.\r\n      ","sponsor":"Cornell University","sponsor_type":"Other","conditions":"Healthy","interventions":[{"intervention_type":"Other","name":"Other: Frequent Self-Weighing","description":"Were given scales to weigh themselves daily. Change in weight was measured at the beginning and end of the two year observation period."}],"outcomes":[{"outcome_type":"primary","measure":"Prevention of age related weight gain by weighing daily","time_frame":"2 years","description":"By weighing oneself daily and seeing a graph of their weight on the scale, the participants will be able to prevent gaining weight over a two year period"}]}
{"nct_id":"NCT01176474","start_date":"2010-08-13","phase":"Phase 1","enrollment":73,"brief_title":"Vaccine Combining Multiple Class I Peptides and Montanide ISA 51VG With Escalating Doses of Anti-PD-1 Antibody Nivolumab or Ipilimumab With Nivolumab For Patients With Resected Stages IIIC/ IV Melanoma","official_title":"A Phase I Trial of a Vaccine Combining Multiple Class I Peptides and Montanide ISA 51VG With Escalating Doses of Anti-PD-1 Antibody Nivolumab or Ipilimumab With Nivolumab For Patients With Resected Stages IIIC/ IV Melanoma","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2022-12-31","last_update":"2021-06-10","description":"The purpose of this study is to test the side effects of an investigational vaccine with an immune booster, or 2 different boosters together. Investigators also want to find out its effects on the immune system and whether it will decrease the chance that melanoma will return.","other_id":"MCC-15651","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":16,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologic diagnosis of resected Stages IIIC/ IV melanoma, with no evidence of disease\r\n             clinically and radiologically. All melanomas regardless of primary site of disease\r\n             will be allowed.\r\n\r\n          -  HLA-A*0201 positive as determined by deoxyribonucleic (DNA) allele-specific polymerase\r\n             chain reaction (PCR) assay; HLA restriction is not required for cohort 4\r\n\r\n          -  Positive staining of most recently resected tumor tissue with antibodies to 1 or more\r\n             of the following: human melanoma black 45 (HMB 45) for gp100, NY-ESO-1, and/or MART-1\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\r\n\r\n          -  Prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor given\r\n             to control the cancer) must have been completed at least 4 weeks before study drug\r\n             administration, and all adverse events have either returned to baseline or stabilized.\r\n\r\n          -  Prior treated brain or meningeal metastases must be without magnetic resonance imaging\r\n             (MRI) evidence of progression for at least 8 weeks and off immunosuppressive doses of\r\n             systemic steroids (> 10 mg/day prednisone or equivalent) for at least 2 weeks before\r\n             study drug administration.\r\n\r\n          -  Prior systemic radiation therapy must have been completed at least 4 weeks before\r\n             study drug administration. Prior focal radiotherapy completed at least 2 weeks before\r\n             study drug administration. No radiopharmaceuticals (strontium, samarium) within 8\r\n             weeks before study drug administration.\r\n\r\n          -  Immunosuppressive doses of systemic medications, such as steroids or absorbed topical\r\n             steroids (doses > 10 mg/day prednisone or equivalent) must be discontinued at least 2\r\n             weeks before study drug administration.\r\n\r\n          -  Completed nitrosourea treatment at least 6 weeks before administration of any study\r\n             drug.\r\n\r\n          -  Prior surgery that required general anesthesia must be completed at least 4 weeks\r\n             before study drug administration. Surgery requiring local/epidural anesthesia must be\r\n             completed at least 72 hours before study drug administration and participants should\r\n             be recovered.\r\n\r\n          -  Screening laboratory values must meet the following criteria: white blood cells (WBCs)\r\n              2000 cells/L, neutrophils  1500 cells/L, platelets  100 x 10^3/L, hemoglobin \r\n             9.0 g/dL, serum creatinine  2 mg/dL, aspartic transaminase (AST)  2.5 x upper limit\r\n             of normal (ULN) without, and  5 x ULN with hepatic metastasis, alanine transaminase\r\n             (ALT)  2.5 x ULN without, and  5 x ULN with hepatic metastasis, bilirubin  2 x ULN\r\n             (except participants with Gilbert's syndrome, who must have total bilirubin < 3.0\r\n             mg/dL).\r\n\r\n          -  Females of childbearing potential (FOCBP) must: Agree to use using a reliable form of\r\n             contraception (e.g., oral contraceptives, intrauterine device, double barrier method\r\n             of condom and spermicidal) for at least 28 days prior to the first dose of any study\r\n             drug, during the Treatment Period (and Treatment/Follow-up if receiving study drug),\r\n             and for at least 70 days after the last dose of any study drug; have a negative serum\r\n             -human chorionic gonadotropin (-HCG) at Screening.\r\n\r\n          -  For female participants to be considered as not having childbearing potential, they\r\n             must meet 1 or more of the following criteria: postmenopausal for at least 24\r\n             consecutive months; surgically sterile (ie, have had a hysterectomy or bilateral\r\n             oophorectomy); females with irregular menstrual periods and/or on hormone replacement\r\n             therapy must have a documented serum follicle stimulating hormone level > 35 mIU/mL.\r\n\r\n          -  Male participants must agree to the use of male contraception during the Treatment\r\n             Period and for at least 180 days after the last dose of any study drug.\r\n\r\n          -  Must have read, understood, and provided written informed consent and Health Insurance\r\n             Portability and Accountability Act (HIPAA) authorization after the nature of the study\r\n             has been fully explained.\r\n\r\n          -  Willing to adhere to the study visit schedule and the prohibitions and restrictions\r\n             specified in this protocol.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of severe hypersensitivity reactions to other monoclonal antibodies (mAbs).\r\n\r\n          -  Systemic hypersensitivity to Montanide ISA 51 VG or any vaccine component.\r\n\r\n          -  Prior non-melanoma malignancy active within the previous 2 years except for locally\r\n             curable cancers that have been apparently cured, such as basal or squamous cell skin\r\n             cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix or\r\n             breast.\r\n\r\n          -  Any active autoimmune disease or documented history of autoimmune disease, or history\r\n             of syndrome that required systemic steroids or immunosuppressive medications, except\r\n             for participants with vitiligo or resolved childhood asthma/atopy.\r\n\r\n          -  Known history of testing positive for human immunodeficiency virus (HIV) or known\r\n             acquired immunodeficiency syndrome (AIDS).\r\n\r\n          -  Positive tests for hepatitis B virus surface antigen (HBV SAg) or hepatitis C virus\r\n             ribonucleic acid (HCV RNA) indicating active or chronic infection.\r\n\r\n          -  Prior therapy with an anti-Programmed Death-1(anti-PD-1), anti-Programmed Death-Ligand\r\n             1 (anti-PD-L1), anti-programmed death-ligand-2 (anti-PD-L2), or anti-cytotoxic T\r\n             lymphocyte-associated antigen 4 (anti-CTLA-4) antibody(or any other antibody targeting\r\n             T cell co-stimulation pathways).\r\n\r\n          -  Concurrent medical condition requiring the use of immunosuppressive medications, or\r\n             immunosuppressive doses of systemic or absorbable topical corticosteroids.\r\n\r\n          -  Underlying medical condition (eg, a condition associated with diarrhea) that, in the\r\n             Investigator's opinion, would make the administration of either study drug or both\r\n             study drugs hazardous to the participant or obscure the interpretation of toxicity\r\n             determination or adverse events.\r\n\r\n          -  Pregnant or nursing.\r\n\r\n          -  Current participation in another clinical study involving treatment with medications,\r\n             radiation or surgery, or prior participation in this study.\r\n      ","sponsor":"H. Lee Moffitt Cancer Center and Research Institute","sponsor_type":"Other","conditions":"Melanoma (Skin)","interventions":[{"intervention_type":"Biological","name":"Biological: NY-ESO-1 157-165 (165V)","description":"The vaccine contains two peptides from two different proteins (peptides are pieces that make up proteins) called gpl00 and NY-ES0-1.\r\nRoute of Administration: When prepared as a vaccine emulsion with Montanide ISA 51 VG, the vaccine is given by deep subcutaneous injection.\r\nMethod of Administration: The 0.5 mg vaccine emulsion dose is administered as a 1 mL injection (0.5 mg/1 mL) as a deep subcutaneous injection in the anterior thigh of the same extremity. Injections should be separated by at least 3 cm to avoid the formation of coalescent granulomas. All 4 peptides (total of 6 injections) will be administered in the same thigh and alternating thighs will be used for each subsequent treatment."},{"intervention_type":"Drug","name":"Drug: Nivolumab","description":"Nivolumab (BMS-936558) is a fully human monoclonal antibody (HuMAb) against programmed death-1 (PD-1).\r\nNivolumab will be given at the following dosages: 1, 3, or 10 mg/kg.\r\nNivolumab will be administered as an i.v. infusion, using a volumetric pump with a 0.2 micron in-line filter at the protocol-specified dose(s) and rate."},{"intervention_type":"Biological","name":"Biological: gp100:280-288 (288V)","description":"The vaccine contains two peptides from two different proteins (peptides are pieces that make up proteins) called gpl00 and NY-ES0-1.\r\nRoute of Administration: When prepared as a vaccine emulsion with Montanide ISA 51 VG, the vaccine is given by deep subcutaneous injection.\r\nMethod of Administration: The 0.5 mg vaccine emulsion dose is administered as a 1 mL injection (0.5 mg/1 mL) as a deep subcutaneous injection in the anterior thigh of the same extremity."},{"intervention_type":"Drug","name":"Drug: Montanide ISA 51 vegetable grade (VG)","description":"Route of Administration: Administer peptide vaccine emulsions prepared with Montanide ISA 51 VG by deep subcutaneous injection.\r\nMethod of Administration: Divide peptide vaccine emulsion dose volumes of greater than 1.5 mL into 2 or more injections. Administer injections typically into the anterior thigh deep subcutaneous tissue. Perform subsequent injections in rotating sites. Use a 20 or 21 gauge needle for deep subcutaneous injection of the peptide vaccine emulsion."},{"intervention_type":"Drug","name":"Drug: Ipilimumab","description":"Ipilimumab will be given at the following dosage: 3 mg/kg.\r\nIpilimumab will be administered as an i.v. infusion, using a volumetric pump with a 0.2 micron in-line filter at the protocol-specified dose(s) and rate."},{"intervention_type":"Procedure","name":"Procedure: Apheresis Procedure","description":"Some blood will be removed from the participant's veins and processed by a machine to remove a small portion of the white cells. The rest of the blood will be returned into their veins. This procedure is called \"apheresis.\" Apheresis is done to collect cells to allow the investigators to understand how their immune system is functioning before and after receiving nivolumab and vaccine. This will be done for research purposes only. The red cells and blood clotting cells will not be permanently removed during this procedure. White blood cells will need to be removed by apheresis before participants receive the study drug."}],"outcomes":[{"outcome_type":"primary","measure":"Time to Relapse","time_frame":"Start of study treatment through end of follow-up period - up to 5 years","description":"Scanning and exams to detect recurrence will take place periodically during treatment and follow-up until relapse is confirmed."},{"outcome_type":"secondary","measure":"Overall Survival (OS)","time_frame":"Start of study treatment until withdrawal of consent for follow-up or death - up to 6 years","description":"OS: Time from start of study treatment until death from any cause."}]}
{"nct_id":"NCT01183715","start_date":"2010-07-31","phase":"Phase 1","enrollment":18,"brief_title":"A Single Dose Study Of PF-05161704 In Healthy Volunteers","official_title":"A Phase 1 Placebo-Controlled Study To Assess The Safety, Tolerability And Pharmacokinetics Of PF-05161704 After Administration Of Single Escalating Oral Doses Under Fed And Fasted Conditions In Healthy Volunteers","primary_completion_date":"2010-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-09-30","last_update":"2019-07-23","description":"The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single oral doses of PF-05161704 in healthy volunteers.","other_id":"B2911001","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Basic Science","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy male and/or female (non child-bearing potential) subjects between the ages of\r\n             18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities\r\n             identified by a detailed medical history, full physical examination, including blood\r\n             pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).\r\n\r\n          -  Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Evidence or history of clinically significant hematological, renal, endocrine,\r\n             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or\r\n             allergic disease (including drug allergies, but excluding untreated, asymptomatic,\r\n             seasonal allergies at time of dosing).\r\n\r\n          -  Any condition possibly affecting drug absorption (eg, gastrectomy).\r\n\r\n          -  History of regular alcohol consumption exceeding 7 drinks/week for females or 14\r\n             drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of\r\n             beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.\r\n\r\n          -  History or evidence of habitual use of tobacco or nicotine containing products within\r\n             3 months of Screening or positive cotinine test at screening or Day 0 of period one\r\n      ","sponsor":"Pfizer","sponsor_type":"Industry","conditions":"Diabetes Mellitus, Type 2","interventions":[{"intervention_type":"Drug","name":"Drug: PF-05161704 or placebo","description":"PF-05161704 will be administered as an extemporaneously prepared suspension in the initially planned dose range of 1.5 mg to 300 mg. Correspondingly, placebo doses will be administered as suspension"},{"intervention_type":"Drug","name":"Drug: PF-05161704 or placebo","description":"PF-05161704 will be administered as an extemporaneously prepared suspension in the initially planned dose range of 1.5 mg to 300 mg. Correspondingly, placebo doses will be administered as suspension"}],"outcomes":[{"outcome_type":"primary","measure":"Single dose pharmacokinetics of PF-05161704 and its metabolite PF-05200145","time_frame":"1 month"},{"outcome_type":"secondary","measure":"Preliminary pharmacodynamics of PF-05161704","time_frame":"1 month"},{"outcome_type":"primary","measure":"Safety and tolerability of escalating single oral doses of PF-05161704 in healthy subjects","time_frame":"1 month"}]}
{"nct_id":"NCT01652950","start_date":"2010-07-31","phase":"N/A","enrollment":10907,"brief_title":"Study Comparing the Effectiveness of Incentives on Physical Activity Behavior in a Health Insured Population","official_title":"A Prospective, Randomized, Study Comparing the Effectiveness of Different Types of Incentives in Increasing Physical Activity Behaviour on the Vitality Health Promotion Programme","primary_completion_date":"2011-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-10-31","last_update":"2012-07-30","description":"Background: Physical inactivity and increased sedentary activity are major lifestyle factors that contribute to increasing burden of disease globally. There is evidence that the rise in prevalence of non-communicable diseases (NCDs) was largely responsible for growth in private insurance spending between 1987 and 2002 in the USA. There is renewed interest by health plans to implement incentivized health promotion programs, in an effort to change health behavior and thereby reduce health care costs related to NCDs. However, the literature on the role of incentives and rewards in influencing physical activity behavior, specifically, is relatively sparse, and the field of behavioral economics applied to health behavior is relatively new. Most studies that have been conducted typically report findings with limited, well-defined incentives that are offered for a short period. These studies generally have shown a moderation in health care costs compared to non-participants. In a cross-sectional study of approximately 940,000 members of a national private health insurance, Discovery Health, the investigators have previously demonstrated a significant and inverse relationship between levels of participation in fitness-related activities and medical claims associated with hospital admissions. More recently, in a retrospective, longitudinal analysis over 5 yrs, amongst more than 300,000 members, the investigators found that participation in fitness-related activities increased over a 5-yr period and was associated with a significantly lower probability of hospital admissions and inpatient claims costs. Aim: The current study primarily aims to prospectively compare the effectiveness of diverse incentives on physical activity behavior, monthly over a 12 month period following registration, in a cohort of newly-enrolled, adult members of the Vitality health promotion program. Study sample and random allocation to groups: Newly enrolled adult members of the Discovery Health medical plan and who have, themselves, prospectively registered for the Vitality health promotion program, will be eligible for the study, and will be invited to participate by Discovery Health. This recruitment, enrollment and random allocation to groups will be initiated via a web-based email communication, from Discovery Health, over a period of 5 months. A final sample of 9000 adult members will be randomly allocated by Discovery Vitality (with replacement) to one of six study (incentive) groups (n=1500 per group) and followed each month for a period of 12 months. The intervention arms include a Control group, in which members will be offered no additional incentives, other than the existing incentives, to engage in all points-earning physical activity. There will also be a Communication Group, in which members will be offered the base program and, in addition, will be sent bi-weekly communications by alternating email and text messaging which included information on the importance of physical activity, tips on accumulating \"fitness points\" on the base program, a status update of points earned and information on benefits and rewards offered. The incentive arms are comprised of a Direct Payment Group, a Charity Incentive Group, a Lottery Pay-out Group, and a Choice Group. In each case, members will be offered the base program and supplementary communication described above. In addition, individuals will be offered the equivalent of one of four possible incentive amounts depending on the level of participation in fitness-related activities. Enrollment will be over a period of 5 months, and the intervention will take place over a period of 12 months, following registration, with a monthly pay-out for the incentive arms of the trial. The following outcomes of interest will be measured: - Number of new participants (registration) in the fitness programs of Vitality - Points earned, as a proxy for levels of participation, for engaging in physical activity (gym visits) - Self-reported measures of physical activity levels, smoking and healthy eating behaviors - Health care claims (de-personalized) for the 12 month period following the 12 months intervention - Survey of attitudes to incentives and rewards in the post-study questionnaire Ethical considerations: Ethics approval has been obtained from the University of Cape Town/ University of Pennsylvania Research Ethics committees. Consent will be obtained from each subject, who agree to participate or 'opt out' and agree that their medical claims and utilization data may be examined in a de-personalised manner according to their group, and level of participation. Further, should a member choose to drop out in the course of the study, or refuse to participate, there will be no adverse impact on their medical plan coverage and they are free to withdraw without prejudice at any time during the course of the study.","other_id":"REC REF 061/2010","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Newly enrolled adult members of the Discovery Health medical plan who voluntarily\r\n             registered and paid a monthly subscription for the health promotion program (Vitality)\r\n             were eligible for the study. The recruitment, enrollment and random allocation to\r\n             intervention arms were initiated via a web-based email communication. Initially, an\r\n             opt-in design was used but because of an exceedingly low enrollment rate in the first\r\n             three months of the study (less than 10%), with permission from the governing IRB, an\r\n             opt-out strategy was employed for the remaining 5 months of the recruitment window,\r\n             resulting in an enrollment rate of 90% during this time period. Altogether, 12121\r\n             eligible persons were recruited electronically, 1046 had invalid email addresses, 163\r\n             opted out and there was no information concerning age for 5 subjects.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Members who opted out. All members were voluntarily screened for participation in\r\n             physical activity, and this is also done on site by participating gyms.\r\n      ","sponsor":"University of Cape Town","sponsor_type":"Other","conditions":"Physical Activity Behavior|Wellness Programs","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Financial incentives","description":"The incentive arms comprised a Direct Payment Group, a Charity Incentive Group, a Lottery Pay-out Group, and a Choice Group. Members were offered the base program and supplementary communication described above. In addition, individuals were offered the equivalent of one of four possible incentive amounts depending on the level of participation in fitness-related activities. Enrollment into the trial took place for a period of 5 months, and the intervention took place over a period of 12 months following registration.\r\nLevel 1: <150 fitness points per month - equivalent to < 1 gym visit per month - no reward, up to Level 5, which was >3000 fitness points/month - equivalent to >20 gym visits/month."}],"outcomes":[{"outcome_type":"primary","measure":"Fitness points","time_frame":"Accrual of fitness points each month for a period of 12 months, following enrollment.","description":"Members accrue 'fitness points' on the basis of documented gym attendance or participation other fitness-related activities. The levels of this variable are described below. • less than 150 fitness points - equivalent to < 1 gym visit per month, 150 to 749 fitness points - equivalent to 1-4 gym visits per month, 750 to 1499 fitness points - equivalent to between 5 and 9 gym visits per month, 1500 to 2999 fitness points - equivalent to between 10 and 19 gym visits per month and > 3000 fitness points - equivalent to 20 or more gym visits per month"}]}
{"nct_id":"NCT00947973","start_date":"2010-07-31","phase":"Phase 2","enrollment":315,"brief_title":"Comparing School Based Interventions for Adolescents With Attention Deficit Hyperactivity Disorder","official_title":"Multisite Study of School Based Treatment Approaches for ADHD Adolescents","primary_completion_date":"2013-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-07-31","last_update":"2016-12-16","description":"This study will compare the efficacy and cost effectiveness of two methods of treating adolescents with attention deficit hyperactivity disorder in school.","other_id":"R01MH082865","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":11,"maximum_age":15,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Meets DSM-IV criteria for ADHD, including all ADHD subtypes (predominately\r\n             inattentive, predominately hyperactive/impulsive, and combined)\r\n\r\n          -  All common comorbid conditions not listed as exclusionary will be included.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Full Scale Intelligence Quotient (FSIQ) less than 80\r\n\r\n          -  Anticipated attendance for participant or parent less than 80% for scheduled\r\n             activities\r\n\r\n          -  Meets diagnostic criteria for bipolar disorder, psychotic disorder, substance\r\n             dependence (but not substance abuse), or obsessive-compulsive disorder (OCD)\r\n      ","sponsor":"Children's Hospital Medical Center, Cincinnati","sponsor_type":"Other","conditions":"Attention Deficit Disorder With Hyperactivity","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Challenging Horizons Program (CHP) after-school model","description":"Interventions delivered by a counselor 2 days a week as an after-school program. Interventions will strengthen skills in materials organization, homework management, studying, note taking, and socialization."},{"intervention_type":"Behavioral","name":"Behavioral: Challenging Horizons Program (CHP) consultation model","description":"Interventions delivered by a mentor (e.g., a teacher or school counselor) as needed, with expert consultation available"}],"outcomes":[{"outcome_type":"primary","measure":"Teacher ratings of academic performance on the Impairment Rating Scale","time_frame":"Measured pre-intervention, 3 times during the intervention, post-intervention, and at a 6-month follow-up"},{"outcome_type":"secondary","measure":"Grade point average (GPA)","time_frame":"Measured pre-intervention, post-intervention, and at a 6-month follow-up"}]}
{"nct_id":"NCT01479205","start_date":"2010-07-31","enrollment":42,"brief_title":"Induction of Allergen Specific Bronchial Immunotolerance After Specific Immunotherapy","official_title":"Security of the Bronchial Allergen Provocation With Mite and Aspergillus and Predictors for a Positive Reaction.","primary_completion_date":"2010-11-30","study_type":"Observational","rec_status":"Completed","completion_date":"2011-09-30","last_update":"2011-11-24","description":"One aim of this study was to find out if the bronchial allergen provocation (BAP) is an appropriate method to appraise the efficacy of a specific immunotherapy (SIT). The investigators had one group of children receiving SIT and one group of patients who denied a SIT although they had an indication for it. Retrospectively the investigators analysed the data of the first BAP and blood parameters specific IgE-mite, total IgE before SIT (November 2008 till February 2010). Prospectively The investigators analysed the lung parameters and allergic labor parameters that we got in the course of the second BAP. The investigators mean parameter was PD20FEV1-mite. Another aim of The investigators study was to find specific immunological differences between children who improved because of SIT and those who showed no improvement. Thus, The investigators compared the levels of total IgE, cumulative IgE-mite and specific IgE-mite before and after SIT and the levels of specific IgG-mite and specific IgG4-mite after SIT.","other_id":"FRAITASIT","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":5,"maximum_age":17,"population":"Children aged 6-17 years of age with house dust mite allergy","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  informed consent\r\n\r\n          -  between 5 and 18 years of age\r\n\r\n          -  diagnosis of a moderate Asthma bronchiale (I-II) in the last 12 months or rhino\r\n             conjunctivitis\r\n\r\n          -  no exacerbation > 4 weeks before Visit\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  age < 5 years > 18 years,\r\n\r\n          -  FEV1 < 75%\r\n\r\n          -  no cooperation to undergo the BAP,\r\n\r\n          -  exacerbation within the last 28 days before Visit\r\n\r\n          -  other serious illnesses\r\n\r\n          -  taking part in other clinical trials < 30 days\r\n      ","sponsor":"Johann Wolfgang Goethe University Hospital","sponsor_type":"Other","conditions":"Mite Allergy|Allergic Asthma","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"improvement in BAP","time_frame":"one year after initiation of SIT","description":"significant improvement of PD20FEV1-mite in BAP"},{"outcome_type":"secondary","measure":"Improvement of quality of life and medication","time_frame":"1 year after initiation of SIT","description":"Via questionnaire (adapted from ISAAC-study) we assessed the quality of life, clinical symptoms and medication scores of the patients included"}]}
{"nct_id":"NCT01600326","start_date":"2010-07-31","phase":"Phase 2","enrollment":30,"brief_title":"A Prospective Comparison of Ultrasound-Guided Percutaneous Platelet-Rich Plasma Injection","official_title":"A Prospective Comparison of Ultrasound-Guided Percutaneous Platelet-Rich Plasma Injection Versus Tenotomy for Treatment of Gluteus Minimus and Medius Tendinosis","primary_completion_date":"2015-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-07-31","last_update":"2017-04-05","description":"The purpose of this study is to determine the effectiveness of various treatment soft tendinosis also known as tendinitis.","other_id":"HUM00039445","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adult subjects with a diagnosis of tendinosis of the hip.\r\n\r\n          -  Adult subjects who have been referred to Dr. Jacobson for the treatment of tendinosis\r\n             by tenotomy.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  pregnancy\r\n\r\n          -  risk of bleeding due to anticoagulant medication\r\n\r\n          -  presence of malignancy\r\n\r\n          -  steroid injection less than 3 months before enrollment\r\n      ","sponsor":"University of Michigan","sponsor_type":"Other","conditions":"Tendinosis|Tendinitis","interventions":[{"intervention_type":"Procedure","name":"Procedure: Tenotomy (no injection)","description":"Subjects randomized to this group will fill out a pre-treatment pain survey and have a blood draw They will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti-inflammatory medications for 2 weeks before the study. Two weeks after enrollment subjects see their referring physician to begin physical therapy."},{"intervention_type":"Drug","name":"Drug: Ultrasound guided platelet rich plasma injection","description":"Subjects will fill out a pre-treatment pain survey, then will undergo ultrasound and have blood drawn from their arm.\r\nThe blood sample will be separated into blood cells and plasma. The plasma portion of the blood (liquid minus the cells) will be injected into the tendon under sterile conditions. Ultrasound will help guide the injection. This is called \"Ultrasound guided platelet rich plasma injection.\"\r\nSubjects will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti inflammatory medications for 2 weeks before the study and 2 weeks after the study.\r\nSubjects will see their referring physician two weeks after treatment to begin physical therapy."}],"outcomes":[{"outcome_type":"primary","measure":"Pain Level and Interference With Activity","time_frame":"Up to 23 days","description":"Patient symptoms are measured on a 50 point scale where 0 is no pain or interference with activities and 50 is highest pain and interference.\r\nA verbal evaluation and assessment of subject's pain and symptoms will be completed prior to treatment. After receiving medication a second evaluation will be taken to determine how well the medication has relieved and controlled the subject's pain and inflammation associated with tendinitis.\r\nSubjects will be specifically asked to rate the level of pain and how the pain is affecting common activities of daily living. The outcomes will be assessed at 2 follow up periods, 1 and approximately 2 weeks after treatment (but no more than 23 days)."},{"outcome_type":"secondary","measure":"Number of Participants Showing Symptomatic Improvement as Assessed in Patient Chart","time_frame":"15 to 555 days post treatment","description":"Information from patient charts were retrospectively reviewed to determine if symptoms were reported as improved, worse, or no change over a time period (range 15 to 555 days post treatment)."}]}
{"nct_id":"NCT02948582","start_date":"2010-07-31","phase":"Phase 2","enrollment":42,"brief_title":"Assessment of the Safety and Ability of a Once-a-day Dose of an Orally Inhaled Medicine [i.e., Glycopyrrolate Inhalation Solution = GIS] to Improve Airflow in the Lungs When Delivered Using an eFlow Nebulizer in Patients With Chronic Obstructive Pulmonary Disease (COPD)","official_title":"Randomized, Placebo-Controlled, Double-Blind, Dose Ranging, Single-Dose, 6-Way Crossover Study to Assess Safety, Efficacy and Pharmacokinetics of EP-101 Using eFlow Nebuliser in Patients With COPD","primary_completion_date":"2010-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-11-30","last_update":"2018-03-12","description":"The study assessed the safety and ability of an orally inhaled medicine [i.e., Glycopyrrolate Inhalation Solution = GIS] to improve airflow in the lungs when delivered using an eFlow nebulizer in 42 patients with Chronic Obstructive Pulmonary Disease (COPD). Each patient randomly received several, single doses of GIS, or placebo, separated by approximately 1 to 2 weeks. After the dose was given, lung airflow was measured over 24 hours and blood was collected to measure how much GIS was in the bloodstream. The study was conducted to find the once-a- day GIS dose that produced the highest improvement in lung airflow using the eFlow nebulizer.","other_id":"EP-101-02","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":40,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Male and female patients aged 40 through 75 years, inclusive\r\n\r\n          2. A clinical diagnosis of COPD according to the GOLD guidelines\r\n\r\n          3. Current smokers or ex-smokers with at least 10 pack-year smoking history (e.g., at\r\n             least 1 pack/day for 10\r\n\r\n          4. Post-bronchodilator FEV1 30-70% of predicted normal at the Screening Visit\r\n\r\n          5. Post-bronchodilator FEV1/FVC ratio < 0.70 at the Screening Visit\r\n\r\n          6. Improvement in FEV1 >12% and 150 mL following inhalation of ipratropium bromide at the\r\n             Screening Visit\r\n\r\n          7. Ability to perform reproducible spirometry according to the ATS/ERS guidelines\r\n\r\n          8. Willing to stay at the study site for approximately 30 hours on each treatment visit\r\n\r\n          9. Willing and able to provide written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Females who are pregnant or lactating at the Screening Visit, or if of childbearing\r\n             potential not using one of the following acceptable means of birth control throughout\r\n             the study:\r\n\r\n               -  Abstinence\r\n\r\n               -  Post-menopausal for at least two years\r\n\r\n               -  Surgically sterile (i.e., tubal ligation, hysterectomy)\r\n\r\n               -  Oral contraceptives (taken for at least one month prior to the Screening Visit)\r\n\r\n               -  Approved implantable or injectable contraceptives (e.g., Norplant, Depo-Provera\r\n                  or equivalent)\r\n\r\n               -  Barrier methods (e.g., condoms with spermicide)\r\n\r\n               -  Intrauterine device (i.e., IUD)\r\n\r\n               -  Vasectomy of male partner\r\n\r\n               -  Non-heterosexual life style\r\n\r\n          2. Current evidence or recent history of any clinically significant disease (other than\r\n             COPD) or abnormality in the opinion of the Investigator that would put the subject at\r\n             risk or which would compromise the quality of the study data; including but not\r\n             limited to cardiovascular disease, myocardial infarction, cardiac failure,\r\n             uncontrolled hypertension, life-threatening arrhythmias, uncontrolled diabetes,\r\n             neurologic or neuromuscular disease, liver disease, gastrointestinal disease or\r\n             electrolyte abnormalities\r\n\r\n          3. Recent history of hospitalization due to an exacerbation of airway disease within 3\r\n             months or need for increased treatments for COPD within 6 weeks prior to the Screening\r\n             Visit\r\n\r\n          4. Primary diagnosis of asthma\r\n\r\n          5. Prior lung volume reduction surgery or history of chest/lung irradiation\r\n\r\n          6. Regular use of daily oxygen therapy\r\n\r\n          7. Use of systemic (eg, intramuscular or intravenous) steroids within 3 months prior to\r\n             the Screening Visit\r\n\r\n          8. Respiratory tract infection within 6 weeks prior to the Screening Visit\r\n\r\n          9. History of tuberculosis, bronchiectasis or other non- specific pulmonary disease\r\n\r\n         10. History of urinary retention or bladder neck obstruction type symptoms\r\n\r\n         11. History of narrow-angle glaucoma\r\n\r\n         12. Clinically significant abnormal ECG\r\n\r\n         13. Positive Hepatitis B surface antigen or positive Hepatitis C antibody\r\n\r\n         14. Positive screening test for HIV antibodies\r\n\r\n         15. Current or recent history (previous 12 months) of excessive use or abuse of alcohol\r\n\r\n         16. Current evidence or history of abusing legal drugs or use of illegal drugs or\r\n             substances\r\n\r\n         17. Donation of 450 mL of blood within 8 weeks of the Screening Visit\r\n\r\n         18. History of hypersensitivity or intolerance to aerosol medications\r\n\r\n         19. Participation in another investigational drug study was received within 30 days prior\r\n             to the Screening Visit\r\n      ","sponsor":"Sunovion Respiratory Development Inc.","sponsor_type":"Industry","conditions":"Chronic Obstructive Pulmonary Disease","interventions":[{"intervention_type":"Drug","name":"Drug: Glycopyrrolate Inhalation Solution12.5g","description":"Glycopyrrolate Inhalation Solution12.5g via eFlow, once daily"},{"intervention_type":"Drug","name":"Drug: Glycopyrrolate Inhalation Solution 50g","description":"Glycopyrrolate Inhalation Solution 50g via eFlow, once daily"},{"intervention_type":"Drug","name":"Drug: Glycopyrrolate Inhalation Solution 100g","description":"Glycopyrrolate Inhalation Solution 100g via eFlow, once daily"},{"intervention_type":"Drug","name":"Drug: Glycopyrrolate Inhalation Solution 200g","description":"Glycopyrrolate Inhalation Solution 200g via eFlow, once daily"},{"intervention_type":"Drug","name":"Drug: Glycopyrrolate Inhalation Solution 400g","description":"Glycopyrrolate Inhalation Solution 400g via eFlow, once daily"},{"intervention_type":"Drug","name":"Drug: Placebo 0.5mL","description":"Placebo 0.5mL via eFlow, once daily"}],"outcomes":[{"outcome_type":"primary","measure":"Trough FEV1 (Change From Baseline)","time_frame":"24hr post dose","description":"Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.\r\nTrough FEV1 was defined as the mean of FEV1 values obtained at 23 hours 30 minutes and 24 hours post-dose of each Treatment Visit."},{"outcome_type":"primary","measure":"Standardized FEV1AUC0-12 Area Under the FEV1 Curve From 0 to 12 Hours Post-dose ( Actual and Change From Baseline).","time_frame":"0-12h post dose","description":"Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.. The standardized actual FEV1 AUC(0-12) was calculated using the trapezoidal rule divided by the actual hours from the first FEV1 to the last FEV1 in the interval. Standardized change from baseline FEV1 AUC(0-12) was also calculated similarly, using the change from pre-dose FEV1."},{"outcome_type":"primary","measure":"Standardized FEV1AUC12-24 Area Under the FEV1 Curve From 12 to 24 Hours Post- Dose (Actual and Change From Baseline).","time_frame":"12-24h post dose","description":"Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. The standardized actual FEV1 AUC(12-24) was calculated using the trapezoidal rule divided by the actual hours from the first FEV1 to the last FEV1 in the interval. Standardized change from baseline FEV1 AUC(12-24) was also calculated similarly, using the change from pre-dose FEV1."},{"outcome_type":"primary","measure":"Standardized FEV1 AUC0-24 Area Under the FEV1 Curve From 0 to 24 Hours Post-dose (Actual and Change Baseline)","time_frame":"0 to 24h","description":"Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. . The standardized actual FEV1 AUC(0-24) was calculated using the trapezoidal rule divided by the actual hours from the first FEV1 to the last FEV1 in the interval. Standardized change from baseline FEV1 AUC(0-24) was also calculated similarly, using the change from pre-dose FEV1."},{"outcome_type":"primary","measure":"Peak FEV1 (Change From Baseline and Percent Change)","time_frame":"0-4h post dose","description":"spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. . The peak FEV1 was defined as the highest post-dose FEV1 value within 4 hrs after the dose. Percent change from baseline was calculated as 100 times the difference of peak FEV1 minus baseline FEV1 divided by baseline FEV1."},{"outcome_type":"secondary","measure":"Cmax; Maximum Observed Plasma Concentration","time_frame":"0 to 12 hour","description":"Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr"},{"outcome_type":"secondary","measure":"Tmax; Time to Maximum Observed Plasma Concentration","time_frame":"0 to 12 hours","description":"Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr"},{"outcome_type":"secondary","measure":"t1/2; Plasma Half-life","time_frame":"0 to 12 hour","description":"Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr"},{"outcome_type":"secondary","measure":"AUC0-t; Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Measurable Drug Concentration.","time_frame":"0 to 12 hour","description":"Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr"},{"outcome_type":"secondary","measure":"AUC0-inf Area Under the Plasma Concentration-time Curve From Time Zero to Infinity","time_frame":"0 to 12 hour","description":"Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr"},{"outcome_type":"secondary","measure":"Number of Subjects Who Died, Number of Subjects With Treatment Emergent SAEs, Number of Subjects Who Discontinued Due to AE","time_frame":"Day 69 (includes dosing Day 1, washout Day 12, safety follow up Day 69)","description":"AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment"},{"outcome_type":"secondary","measure":"Number of Subjects With Clinically Significant Abnormal Vital Signs Reported During the Study","time_frame":"0-24 h","description":"Vital signs were measured at screening and at each Treatment Visit pre-dose (within 30 minutes prior to dose); post-dose at 30 minutes and 1, 2, 4, 8, 12 and 24 hours; and then at the post study assessment."},{"outcome_type":"secondary","measure":"Number of Clinically Significant Abnormal Laboratory Results Reported During the Study","time_frame":"Day -14, Day 69","description":"Clinical safety lab parameters were collected at screening and at the post study assessment. Any laboratory values that were out of range of normal reference values were evaluated by the Investigators."},{"outcome_type":"secondary","measure":"Number of Subjects With Clinically Significant ECG Parameters Reported During the Study","time_frame":"0 to 24h","description":"ECGs were recorded at screening and at each study treatment visit pre-dose (within 30 minutes prior to dose); post-dose at 30 minutes and 1, 2, 4, 8, 12 and 24 hours; and then at the post study assessment."},{"outcome_type":"secondary","measure":"Percentage of Subjects With Treatment Emergent AEs","time_frame":"Day 69 (includes dosing Day 1, washout Day 12, safety follow up Day 69)","description":"AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment"}]}
{"nct_id":"NCT01314066","start_date":"2010-07-31","phase":"Phase 2","enrollment":0,"brief_title":"Efficacy of Bevacizumab in Preventing Acute Respiratory Distress Syndrome (ARDS)","official_title":"Efficacy of Bevacizumab in Preventing Acute Respiratory Distress Syndrome (ARDS)","primary_completion_date":"2015-11-30","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2016-02-29","last_update":"2016-05-03","description":"This study aims to test the effectiveness of a single intravenous (IV, through the vein) dose of the study drug, bevacizumab (Avastin), in preventing/reducing the development of Acute Respiratory Distress Syndrome (ARDS), in patients with severe sepsis, who are at high risk for developing ARDS. ARDS is a lung disease caused by a lung injury that leads to lung function impairment. The condition the patient has,severe sepsis, is a medical condition associated with an infection characterized as an immune system inflammatory response throughout your whole body that can lead to organ dysfunction, low blood pressure or insufficient blood flow to one or more of your organs.","other_id":"IRB Protocol #0907010498","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":99,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Clinical Diagnosis of Sepsis based on Modified Inflammatory Response Syndrome (SIRS)\r\n             Criteria\r\n\r\n          -  Evidence of a systemic response to infection\r\n\r\n          -  1 or more sepsis-induced organ failures modified from those as defined by Bernard, et\r\n             al. (eg. PROWESS rhAPC study, NEJM)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnant females\r\n\r\n          -  Systolic blood pressure >170\r\n\r\n          -  Diastolic blood pressure >110\r\n\r\n          -  Preexisting proteinuria >0.3 g/24hr\r\n\r\n          -  Known hypersensitivity to bevacizumab\r\n\r\n          -  Subject or health care agent unable to provide written informed consent\r\n\r\n          -  Diagnosis of lung cancer with active hemoptysis\r\n\r\n          -  Patient not expected to survive 28 days independently of the septic episode due to\r\n             severe underlying disease\r\n\r\n          -  Presence of an advanced directive to withhold life-sustaining treatment\r\n\r\n          -  Participation in another investigational study within 30 days of enrollment\r\n\r\n          -  GI tract perforation and/or repair unless surgical incision is fully healed\r\n\r\n          -  Any major surgery in the 28 days prior to enrollment\r\n\r\n          -  Need for non-elective major surgery within 28 days\r\n\r\n          -  Presence of enterocutaneous fistula (an abnormal connection between body cavities, in\r\n             this case, from the intestine to the skin. Possible complication of surgery, where\r\n             passageway progresses from intestine to surgery site to skin)\r\n\r\n          -  Known or suspected tracheoesophageal fistula (an abnormal connection between the\r\n             esophagus and the trachea)\r\n\r\n          -  Current ICU stay of > 2 months prior to enrollment\r\n\r\n          -  Need for therapeutic anti-coagulation\r\n      ","sponsor":"Weill Medical College of Cornell University","sponsor_type":"Other","conditions":"Severe Sepsis|Acute Respiratory Distress Syndrome","interventions":[{"intervention_type":"Drug","name":"Drug: Bevacizumab","description":"Patients receiving drug will receive it as a single dose. Treatment will be given as 90-minute IV infusion. The patient will either receive Bevacizumab at 5 mg/kg OR Bevacizumab at 10 mg/kg."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Patients assigned to placebo-control group will receive a single dose of saline solution as a 90 minute IV infusion"}],"outcomes":[{"outcome_type":"primary","measure":"Proportion of individuals progressing to meet RDS criteria as defined by the American- European ARDS consensus conference and as used by ARDSnet.","time_frame":"Day 28"},{"outcome_type":"secondary","measure":"Ventilator-free days to Day 28","time_frame":"Day 28"},{"outcome_type":"secondary","measure":"28 day all-cause mortality","time_frame":"Day 28"},{"outcome_type":"secondary","measure":"Proportion of subjects progressing to acute lung injury (who do not meet the definition at randomization)","time_frame":"Day 28"},{"outcome_type":"secondary","measure":"Worst PaO2/FiO2 ratio recorded following enrollment","time_frame":"Day 3 and 28"},{"outcome_type":"secondary","measure":"Change in PaO2/FiO2 ratio between Day 0 to Day 3","time_frame":"Day 0 and Day 3"},{"outcome_type":"secondary","measure":"Change from baseline in number of non-lung organ failures using the Multi-Organ Dysfunction (MOD) score and Sepsis Organ Failure Assessment (SOFA) score","time_frame":"Day 0, Day 28"},{"outcome_type":"secondary","measure":"Proportion of subjects surviving to hospital discharge","time_frame":"Hospital Discharge Day"},{"outcome_type":"secondary","measure":"Vasopressor-free days","time_frame":"Day 28"},{"outcome_type":"secondary","measure":"Reversal of shock if present at randomization.","time_frame":"Day 28"}]}
{"nct_id":"NCT01163903","start_date":"2010-07-31","phase":"Phase 1","enrollment":24,"brief_title":"Pantoprazole With Doxorubicin for Advanced Cancer Patients With Extension Cohort of Patients With Solid Tumours","official_title":"A Phase I Study Evaluating the Proton Pump Inhibitor Pantoprazole in Combination With Doxorubicin for Advanced Cancer Patients With an Extension Cohort of Patients With Solid Tumours","primary_completion_date":"2014-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-05-31","last_update":"2015-07-15","description":"This is a single-centre, open label, dose finding, phase I study to determine the recommended phase II dose (RP2D) for the combination of doxorubicin and pantoprazole in patients with advanced tumours and no standard treatment options. A minimum of 3 patients will be enrolled per dose level and intra-patient dose escalation is not permitted. Once the RP2D has been identified, six additional patients with metastatic solid tumours will be treated at the RP2D to confirm its tolerability.","other_id":"DDP-IT-01","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patients must have histologically or cytologically proven advanced solid tumours for\r\n             whom no standard anticancer therapy exists\r\n\r\n          2. Measureable and non-measureable disease are both eligible, but disease must be\r\n             evaluable as defined by RECIST 1.1.\r\n\r\n          3. Patients >18 years old\r\n\r\n          4. At least 21 days since last chemotherapy regimen and/or radiotherapy\r\n\r\n          5. Recovery from all reversible adverse events of previous anticancer therapies to\r\n             baseline or to grade < or =1, except for alopecia.\r\n\r\n          6. Patients must have documented evidence of disease progression on prior systemic\r\n             therapy.\r\n\r\n          7. ECOG Performance Status of 0 or 1\r\n\r\n          8. Adequate cardiovascular function and no history of serious cardiac diseases (see\r\n             Exclusion criteria for definition) Left ventricular ejection fraction > 50% by\r\n             multi-gated nuclear angiogram\r\n\r\n          9. Patient consent must be obtained according to Institutional REB requirements. The\r\n             patient must sign the consent form prior to registration.\r\n\r\n         10. Patients must be accessible for treatment and follow-up.\r\n\r\n         11. Previous Therapy\r\n\r\n               1. Chemotherapy: Patients can have had limited exposure to prior anthracyclines\r\n                  defined as no more than a total dose of 240 mg/m2 of doxorubicin or 300 mg/m2 of\r\n                  epirubicin (e.g. as received in the AC x 4 or FEC x 3 adjuvant regimens).\r\n                  Patients with prior exposure to other cardiotoxic anticancer drugs (e.g.\r\n                  mitoxantrone) are not eligible.\r\n\r\n               2. Radiation: Patients may have had prior radiation therapy (including that to the\r\n                  breast or chest wall) provided that has not exceeded 25% of the bone marrow\r\n                  reserve.\r\n\r\n               3. Previous Surgery: Previous surgery is permitted provided that wound healing has\r\n                  occurred.\r\n\r\n               4. Hormonal Therapy: Patients may have had prior hormonal therapy. All hormonal\r\n                  agents must be discontinued at least 3 weeks prior to study entry.\r\n\r\n         12. Laboratory Requirements (must be done within 7 days prior to registration)\r\n\r\n               1. Neutrophil count (ANC) > or = 1.5 x 10^9/L\r\n\r\n               2. Hemoglobin > or = 90 g/L\r\n\r\n               3. Platelet count > or = 100 x 10^9/L\r\n\r\n               4. Bilirubin <1.5 x UNL\r\n\r\n               5. AST or ALT < or = 2 x UNL\r\n\r\n               6. Creatinine < or = 1.5 x UNL or creatinine clearance > or = 50mL/min\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients who have previously received more than 240 mg/m2 doxorubicin or 300 mg/m2\r\n             epirubicin.\r\n\r\n          2. Patients receiving concurrent treatment with experimental drugs or anti-cancer\r\n             therapy.\r\n\r\n          3. Patients who are receiving drugs that are known to interact with pantoprazole,\r\n             including:\r\n\r\n               1. The anti-fungal agents fluconazole, itraconazole, ketoconazole, posaconazole,\r\n                  voriconazole;\r\n\r\n               2. The antiviral agents: atazanavir, delavirdine, indinavir, nelfinavir,\r\n                  raltegravir, saquinavir, tipranavir;\r\n\r\n               3. The anticoagulant agents: clopidogrel, dabigatran;\r\n\r\n               4. The immunosuppressive agent: mycophenolate\r\n\r\n               5. The anti-inflammatory agent: mesalamine\r\n\r\n          4. Patients who are receiving oral pantoprazole or other PPI inhibitors may participate\r\n             if these agents are discontinued at least 7 days before trial entry.\r\n\r\n          5. Patients with untreated brain or meningeal metastases. (MR or CT scans are not\r\n             required to rule this out unless there is a clinical suspicion of CNS disease).\r\n             Patients with treated and stable brain metastases are eligible providing that they\r\n             have radiological evidence of disease stabilization of at least 3 months duration and\r\n             are asymptomatic.\r\n\r\n          6. Patients who have a history of clinically significant cardiac disease, including:\r\n\r\n               1. Unstable angina/ acute coronary syndrome\r\n\r\n               2. Congestive heart failure\r\n\r\n               3. Myocardial infarction within the past year\r\n\r\n               4. Clinically significant arrhythmia\r\n\r\n               5. Pericarditis or myocarditis\r\n\r\n               6. Symptomatic valvular disease Patients with well-controlled hypertension,\r\n                  uncomplicated mitral valve prolapsed or other stable cardiac conditions are\r\n                  eligible.\r\n\r\n          7. Patients with active or uncontrolled infections or with serious illnesses or medical\r\n             conditions that would not permit the patient to be managed according to the protocol.\r\n\r\n          8. Patients with a known bleeding disorder. Patients who are on stable anticoagulation\r\n             with warfarin or s.c. heparin products are eligible. Patients receiving clopidogrel\r\n             are excluded.\r\n\r\n          9. Patients unable or unwilling to give written, informed consent prior to study\r\n             participation.\r\n\r\n         10. Women who are pregnant or nursing.\r\n      ","sponsor":"University Health Network, Toronto","sponsor_type":"Other","conditions":"Advanced Solid Tumours","interventions":[{"intervention_type":"Drug","name":"Drug: pantoprazole sodium for injection","description":"Single 3-weekly doses of pantoprazole using the following dose escalation scheme for successive groups of patients: 80, 160, 240 and 320mg i.v. of pantoprazole to be given every 3 weeks, 30-60 (5) minutes prior to doxorubicin. Treatment will be repeated on Day 1 of a 21-day cycle until radiographic or symptomatic progression or unacceptable toxicity or a maximum of 4 cycles (for patients who have received prior anthracyclines), and up to 8 cycles (for those with no prior exposure to anthracyclines)."},{"intervention_type":"Drug","name":"Drug: doxorubicin hydrochloride injection","description":"60 mg/m2, IV, scheduled on day 1 of every 3-week interval, 30-60 (5) minutes after pantoprazole administration."}],"outcomes":[{"outcome_type":"primary","measure":"Determination of recommended phase II dose (RP2D) of pantoprazole given with doxorubicin at 60mg/m2","time_frame":"Treatment until documented progression or up to 8 21-day cycles (4 cycles if prior anthracyclines received). All patients followed for late toxicities, every 3 months for 1 year or until all drug related toxicities are resolved/become unrelated.","description":"To determine the recommended phase II dose (RP2D) of pantoprazole given with doxorubicin at 60mg/m2 when administered to adult patients with advanced solid tumours."},{"outcome_type":"secondary","measure":"Characterize the safety and tolerability of the combination by determining dose-limiting toxicities (DLTs). Toxicities evaluated and graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.","time_frame":"Treatment until documented progression or up to 8 21-day cycles (4 cycles if prior anthracyclines received). All patients followed for late toxicities, every 3 months for 1 year or until all drug related toxicities are resolved/become unrelated.","description":"Three or 6 patients will be treated per cohort for at least one cycle (21 days per cycle). If two patients experience DLTs, then accrual will stop at that level, and the next lower dose level in which six patients have been treated with no or only 1 DLT will be declared the RP2D. Once the RP2D has been identified, six additional patients will be treated at the RP2D to confirm its safety and tolerability. Patients will be assessed for toxicities using the overall safety profile as per National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0."},{"outcome_type":"secondary","measure":"Assess the preliminary anti-tumour activity of the doxorubicin/pantoprazole by combination in patients with advanced solid tumours, by evaluating tumour response rate.","time_frame":"Radiologic evaluation (CT scan of chest, abdomen and pelvis) performed every 9 weeks","description":"Response Evaluation Criteria in Solid Tumours (RECIST) will be used to determine radiological tumour response for measurable disease and disease progression. Changes in only the largest diameter (unidimensional measurement) of the tumour lesions are used in the RECIST criteria. Any radiological change should be confirmed using a second follow-up scan, 6 or more weeks later. For response there must be no new lesions and no evidence of progression of non-measurable lesions."},{"outcome_type":"secondary","measure":"Evaluate the pharmacokinetics of doxorubicin and pantoprazole when given in combination by collecting venous blood samples at various timepoints throughout study drug administration.","time_frame":"Blood samples just before and at the end of pantoprazole and doxorubicin administration, and at 1, 2, 4, 8, 24, 48 and 72 hours after (first or second) drug administration for evaluation of serum levels of doxorubicin and pantoprazole"},{"outcome_type":"secondary","measure":"Evaluate (in selected patients with lesions amenable to biopsy) the influence of pantoprazole on distribution of doxorubicin in tumour tissue. Tumour tissue extracted after administration of doxorubicin/pantoprazole.","time_frame":"Tumour biopsy within 24-48h after administration of doxorubicin (in consenting patients with disease amenable to biopsy)","description":"Two cores of tumour tissue will be extracted within 24-48 hours of administration of doxorubicin and pantoprazole;1 core will be fixed for routine pathological examination and the 2nd will be fresh frozen. The latter will be sectioned in the experimental pathology laboratory and will be stained with antibodies which recognize tumour blood vessels and regions of hypoxia. Distribution of doxorubicin (which is fluorescent) in relation to the blood vessels in tumours, and in relation to hypoxic regions, will then be quantified using immunohistochemistry at an advanced optical microscopy facility."}]}
{"nct_id":"NCT01161108","start_date":"2010-07-31","phase":"Phase 3","enrollment":13,"brief_title":"Trial of Melatonin to Improve Sleep in Children With Epilepsy and Neurodevelopmental Disabilities","official_title":"A Randomized Controlled Trial Pilot Project to Evaluate the Efficacy of Melatonin in Children With Insomnia, Intractable Epilepsy and Neurodevelopmental Disabilities","primary_completion_date":"2012-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-06-30","last_update":"2014-12-02","description":"The purpose of the study is to evaluate the safety and efficacy of oral melatonin in improving sleep continuity in children with epilepsy and neurodevelopmental delay who have chronic insomnia by comparing Fast Release Melatonin (FR MLT) to placebo and Timed Release Melatonin (TR MLT) with placebo in a randomized cross-over design trial.","other_id":"1000010842","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":5,"maximum_age":17,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Children aged 5-17 years\r\n\r\n          -  Children with epilepsy with at least 2 partial or generalized seizures per month over\r\n             the last 3 months prior to starting the trial\r\n\r\n          -  Children with neurodevelopmental disability, i.e. significant delay in development\r\n             requiring special educational setting or educational assistant\r\n\r\n          -  Anti-epileptic drugs (AED's) expected to remain unchanged for duration of trial (14\r\n             weeks)\r\n\r\n          -  Not currently using melatonin or any other medication for sleep Subjects will be\r\n             eligible if they have previous use of melatonin as long as there is a washout period\r\n             of at least 1 week. Similarly, children taking natural health products for sleep will\r\n             be included as long as there is a 30 day washout period prior to study enrollment.\r\n\r\n          -  Chronic insomnia - reported by parent(s) to include one of the following: sleep onset\r\n             latency of greater than one hour, duration of sleep less than 8.5 hours per night with\r\n             either/or both these problems occurring at least 3 nights per week and that have\r\n             occurred 3 months prior to trial, or night wakings of more than 2 per night for same\r\n             time period\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Planned epilepsy surgery or change in AED's during treatment trial\r\n\r\n          -  Sleep disturbances that are treatable such as obstructive sleep apnea\r\n\r\n          -  Allergy or severe adverse effects to melatonin\r\n\r\n          -  Allergy or severe adverse effects to any of the ingredients of the study product or\r\n             placebo (e.g. lactose)\r\n\r\n          -  Lactose intolerance\r\n\r\n          -  Pregnant\r\n\r\n          -  Breastfeeding\r\n\r\n          -  Known liver disease\r\n\r\n          -  Ketogenic diet\r\n\r\n          -  Other drugs being used for sedation\r\n\r\n          -  Immunosuppressive drugs\r\n\r\n          -  Known blood clotting abnormalities or who are on anticoagulant therapy (e.g. warfarin,\r\n             blood thinners)\r\n      ","sponsor":"The Hospital for Sick Children","sponsor_type":"Other","conditions":"Epilepsy|Insomnia|Developmental Disability","interventions":[{"intervention_type":"Drug","name":"Drug: Fast Release Melatonin (FR MLT)","description":"3mg capsules of melatonin will be used. The dose of FR MLT will be 3 mg for children less than or equal to 20 kg, and 6 mg for children greater than 20 kg. The study medication will be given one hour before bedtime, once daily."},{"intervention_type":"Drug","name":"Drug: Fast Release Placebo","description":"A matching FR MLT placebo will be compounded by the SickKids research pharmacy.\r\nThe dose of Fast Release Placebo will be 3 mg for children less than or equal to 20 kg, and 6 mg for children greater than 20 kg. The study medication will be given one hour before bedtime, once daily."},{"intervention_type":"Drug","name":"Drug: Timed Release Melatonin (TR MLT)","description":"3 mg capsules will be used.\r\nThe dose of TR MLT will be will be 3 mg for children less than or equal to 20 kg, and 6 mg for children greater than 20 kg. The study medication will be given one hour before bedtime, once daily."},{"intervention_type":"Drug","name":"Drug: Timed Release Placebo","description":"A matching TR MLT placebo will be compounded by the SickKids research pharmacy.\r\nThe dose of Timed Release Placebo will be will be 3 mg for children less than or equal to 20 kg, and 6 mg for children greater than 20 kg. The study medication will be given one hour before bedtime, once daily."}],"outcomes":[{"outcome_type":"primary","measure":"Change in duration of nocturnal sleep time","time_frame":"Baseline, Weeks 9 and 13","description":"We will measure the sleep time between 7 pm and 9 am.\r\nThe measures will be analyzed to determine the change from baseline and change between active treatment and placebo."},{"outcome_type":"secondary","measure":"Sleep onset latency","time_frame":"Baseline, Weeks 9 and 13","description":"We will measure the interval of time between lights out and the onset of sleep.\r\nThe measures will be analyzed to determine the change from baseline and change between active treatment and placebo."},{"outcome_type":"secondary","measure":"Sleep efficiency","time_frame":"Baseline, Weeks 9 and 13","description":"We will measure the time sleeping/time in bed between lights out at night and lights on in the morning.\r\nThe measures will be analyzed to determine the change from baseline and change between active treatment and placebo"}]}
{"nct_id":"NCT01961986","start_date":"2010-07-31","phase":"N/A","enrollment":120,"brief_title":"Rotator Cuff Sparing Total Arthroplasty","official_title":"Rotator Cuff Sparing Total Arthroplasty - A Prospective, Randomized Clinical Trial","primary_completion_date":"2017-05-04","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2022-05-04","last_update":"2021-08-24","description":"Design: Prospective, randomized clinical trial, of 120 patients requiring a total shoulder replacement (TSR). Purpose: To collect and evaluate long-term clinical data on patients whose total shoulder replacement (TSR) is performed using the traditional surgical approach (called the subscapularis release approach) as compared to patients who have a TSR procedure done using a newer surgical approach (called the rotator cuff sparing approach).","other_id":"10-02125","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":21,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patient is indicated for shoulder joint replacement\r\n\r\n          -  Patient is at least 21 years of age\r\n\r\n          -  Patient is expected to survive at least 2 years beyond surgery\r\n\r\n          -  Patient is willing to participate by complying with pre-and post-operative visit\r\n             requirements\r\n\r\n          -  Patient is willing and able to review and sign a study informed consent form\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior arthroplasty in the affected shoulder.\r\n\r\n          -  Significant deformity of the proximal humerus that requires a custom made implant or\r\n             where osteotomy of the shaft and / or the tuberosity has to be considered.\r\n\r\n          -  Significant medial erosion of the glenoid such that lateral edge of the humeral head\r\n             lies medial to the lateral rim of the acromion.\r\n\r\n          -  Significant injury to the brachial plexus\r\n\r\n          -  Inability or unwillingness to participate in the post operative evaluation for the\r\n             entire 24 months period.\r\n\r\n          -  Pregnant and lactating women will be excluded\r\n      ","sponsor":"NYU Langone Health","sponsor_type":"Other","conditions":"Osteoarthritis|Inflammatory Arthritis","interventions":[{"intervention_type":"Procedure","name":"Procedure: TSR - traditional subscapularis release","description":"Total Shoulder Replacement surgery performed using the traditional subscapularis release approach."},{"intervention_type":"Procedure","name":"Procedure: TSR - rotator cuff sparing","description":"Total Shoulder Replacement surgery performed using the rotator cuff sparing approach."}],"outcomes":[{"outcome_type":"primary","measure":"Functional Outcome","time_frame":"Preoperatively","description":"Patient subjective and objective data will be collected for all patients using the Short Form 12 (SF-12)and Patient Assessment forms. From these forms, both American Shoulder and Elbow Society (ASES) outcome score and the Constant score can be derived to assess functional outcome. Additional data will also be collected specific to the integrity and the function of the subscapularis tendon that include the results of the \"belly press\" and the \"lift off\" test. They will be graded as \"unable\", \"maintain against gravity\", \"maintain against resistance\", and \"full strength.\""}]}
{"nct_id":"NCT01190423","start_date":"2010-07-31","phase":"N/A","enrollment":22,"brief_title":"Treatment for Young Adults With Anorexia Nervosa","official_title":"Family-Based Treatment for Weight Restoration in Young Adults With Anorexia Nervosa","primary_completion_date":"2016-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-04-30","last_update":"2018-04-17","description":"Temple University is conducting a National Institute of Health funded research study designed to develop and refine a family-based treatment manual for young adults with Anorexia Nervosa as well as assess the feasibility of this out-patient psychotherapy.","other_id":"20550","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":30,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Meet DSM-IV criteria for AN (restricting/binge-purge type) (BMI 16.0-18.5)\r\n\r\n          -  Medically stable for outpatient treatment\r\n\r\n          -  Availability of at least one supportive adult of choice in study client's environment\r\n\r\n          -  Stable dose of psychotropic medication (8 weeks) for co-morbid condition\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Associated physical illness that necessitates hospitalization\r\n\r\n          -  Psychotic illness or other mental illness requiring hospitalization\r\n\r\n          -  Current dependence on drugs or alcohol\r\n\r\n          -  Physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or\r\n             weight\r\n\r\n          -  Previous Family-Based Treatment for Anorexia\r\n      ","sponsor":"Temple University","sponsor_type":"Other","conditions":"Anorexia Nervosa","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Family Based Therapy for young adults","description":"Individual and Group Therapy Sessions"}],"outcomes":[{"outcome_type":"primary","measure":"Weight (BMI)","time_frame":"6 months of treatment"},{"outcome_type":"secondary","measure":"Changes in shape and weight concerns as measured with Eating Disorder Examination subscales","time_frame":"18 therapy sessions or 6 months of treatment"}]}
{"nct_id":"NCT01101282","start_date":"2010-07-31","phase":"N/A","enrollment":92,"brief_title":"Does Positive Expiratory Pressure Mask Therapy Improve Recovery From Acute Exacerbations of Chronic Obstructive Pulmonary Disease?","official_title":"Does the Addition of Positive Expiratory Pressure (PEP) Mask Therapy to Usual Medical Care Improve Patients' Symptoms, Quality or Life and Risk of Future Exacerbations in Individuals With Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)?","primary_completion_date":"2013-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-01-31","last_update":"2013-02-15","description":"This study aims to identify whether the addition of positive expiratory pressure (PEP) mask therapy to standard medical care improves clinically important outcomes in individuals with acute exacerbations of chronic obstructive pulmonary disease. It is hypothesized that those who receive the additional PEP mask therapy will show greater improvements than those who do not.","other_id":"(not yet specified)","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria (all of the following criteria must be met):\r\n\r\n          -  The primary reason for hospital admission is an acute exacerbation of clinically\r\n             diagnosed COPD\r\n\r\n          -  There is evidence of sputum expectoration or they are a chronic sputum producer\r\n             ('regularly expectorates sputum on most days')\r\n\r\n          -  They are able and willing to provide written, informed consent\r\n\r\n          -  Recent (within the last 6 months) lung function data indicates obstructive lung\r\n             disease (of any severity), according to the GOLD criteria: post-bronchodilator\r\n             FEV1/FVC < 0.7 (only if available)\r\n\r\n          -  They have a smoking history of  10 pack/years (only if diagnosis unclear)\r\n\r\n        Exclusion Criteria (none of the following criteria must be present):\r\n\r\n          -  They are breathing via an artificial airway (e.g. endotracheal or tracheostomy tube)\r\n\r\n          -  They have a more significant respiratory disease other than COPD (e.g. primary\r\n             diagnosis of bronchiectasis, cystic fibrosis, interstitial lung disease, asthma, lung\r\n             cancer)\r\n\r\n          -  They have had recent (within the last 6 months) lung volume reduction procedure(s)\r\n             (e.g. surgery, valve or stent insertion, or other), lung transplantation or\r\n             pneumonectomy\r\n\r\n          -  The intervention is contraindicated (including but not limited to evidence of\r\n             undrained pneumothorax, significant frank haemoptysis, recent facial, oral,\r\n             oesophageal or skull surgery/trauma, altered conscious state or inability to\r\n             co-operate)\r\n\r\n          -  They have poor oxygen saturation at rest (SpO2 < 88%) despite supplemental oxygen\r\n             delivered via nasal prongs\r\n\r\n          -  They intend to continue performing established ACT routines throughout the study\r\n             period\r\n\r\n          -  It is more than 48 hours since being admitted as an inpatient to hospital.\r\n      ","sponsor":"La Trobe University","sponsor_type":"Other","conditions":"Pulmonary Disease, Chronic Obstructive|Lung Diseases, Obstructive","interventions":[{"intervention_type":"Device","name":"Device: Positive expiratory pressure (PEP) mask therapy","description":"PEP mask therapy will be performed once/day, supervised, by an experienced physiotherapist until hospital discharge or  24 hours without sputum expectoration (whichever comes first). Written instructions shall also be provided, encouraging two more independent PEP mask sessions per day. Each session will comprise up to 5 cycles of 8-10 slightly active breaths, followed by 2 huffs (FET) and 2 coughs. A target pressure of 10-20 cms H20 during the middle of expiration shall be used (monitored via a pressure manometer)."}],"outcomes":[{"outcome_type":"secondary","measure":"Lung function (spirometry)","time_frame":"6 months following hospital discharge","description":"e.g. FEV1, FVC, FEV1/FVC%"},{"outcome_type":"secondary","measure":"Mortality (actual, all cause)","time_frame":"At hospital discharge (up to approx. day 10)","description":"Measured as number of events"},{"outcome_type":"primary","measure":"Symptom severity","time_frame":"Within 48 hours of presenting to hospital (day 1)","description":"Measured via the Breathlessness, Cough and Sputum Scale (BCSS)."},{"outcome_type":"primary","measure":"Symptom severity","time_frame":"At hospital discharge (up to approx. day 10)","description":"Measured via the BCSS"},{"outcome_type":"primary","measure":"Symptom severity","time_frame":"8 weeks following hospital discharge","description":"Measured via the BCSS"},{"outcome_type":"primary","measure":"Symptom severity","time_frame":"6 months following hospital discharge","description":"Measured via the BCSS"},{"outcome_type":"secondary","measure":"Disease-specific quality of life","time_frame":"Within 48 hours of presenting to hospital (day 1)","description":"Measured via the 4-week English (Australian) version of the St. George's Respiratory Questionnaire (SGRQ)."},{"outcome_type":"secondary","measure":"Disease-specific quality of life","time_frame":"8 weeks following hospital discharge","description":"Measured via the SGRQ"},{"outcome_type":"secondary","measure":"Disease-specific quality of life","time_frame":"6 months following hospital discharge","description":"Measured via the SGRQ"},{"outcome_type":"secondary","measure":"Need for assisted (non-invasive and/or invasive) ventilation during hospitalisation (within, and after 48 hours of presentation to hospital)","time_frame":"At hospital discharge (up to approx. day 10)","description":"The number of participants needing non-invasive or invasive ventilation during their inpatient stay shall be assessed. As early non-invasive ventilation is commonly used for the management of acute exacerbations of COPD, this outcome shall be assessed both within and after 48 hours of presentation to hospital. This aims to differentiate usual care from clinical deterioration."},{"outcome_type":"secondary","measure":"Hospital length of stay","time_frame":"At hospital discharge (up to approx. day 10)","description":"Measured as number of days"},{"outcome_type":"secondary","measure":"Time to first exacerbation","time_frame":"6 months following hospital discharge","description":"Measured as number of days"},{"outcome_type":"secondary","measure":"Time to first hospitalisation (due to respiratory illness)","time_frame":"6 months following hospital discharge","description":"Measured as number of days"},{"outcome_type":"secondary","measure":"Number of acute exacerbations","time_frame":"6 months following hospital discharge","description":"Measured as number of events"},{"outcome_type":"secondary","measure":"Number of hospitalisations (due to respiratory illness)","time_frame":"6 months following hospital discharge","description":"Measured as number of events"},{"outcome_type":"secondary","measure":"Total number of hospitalised days","time_frame":"6 months following hospital discharge","description":"Measured as number of hospitalised days"},{"outcome_type":"secondary","measure":"Lung function (spirometry)","time_frame":"At hospital discharge (up to approx. day 10)","description":"e.g. FEV1, FVC, FEV1/FVC%"},{"outcome_type":"secondary","measure":"Mortality (actual, all cause)","time_frame":"6 months following hospital discharge","description":"Measured as number of events"},{"outcome_type":"secondary","measure":"Mortality (predicted)","time_frame":"At hospital discharge (up to approx. day 10)","description":"Measured via calculation of the BODE index. The BODE index is derived from: Body mass index, Obstruction severity (spirometry), Dyspnoea (MRC dyspnoea scale) and Exercise tolerance (6 minute walk test)."},{"outcome_type":"secondary","measure":"Mortality (predicted)","time_frame":"6 months following hospital discharge","description":"Measured via BODE index"}]}
{"nct_id":"NCT01145872","start_date":"2010-07-31","phase":"Phase 3","enrollment":92,"brief_title":"The Effects and Mechanisms of Mindfulness Based Cognitive Therapy (MBCT) on Depressive Symptoms and Depression Relapse","official_title":"The Effects and Mechanisms of MBCT on Depressive Symptoms and Depression Relapse","primary_completion_date":"2012-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-04-30","last_update":"2014-12-02","description":"This research proposal is intended to elucidate the efficacy and mechanisms underlying Mindfulness Based Cognitive Therapy (MBCT) in a population in remission from recurrent Major Depressive Disorder (MDD). The first objective of the study is to replicate previous studies' findings of MBCT's effects on decreasing depressive symptoms and depression relapse rates. However, this proposal aims to make a novel contribution to the literature by using a randomized, controlled design, and comparing the effects of MBCT to an active control condition (ACC). The use of a well-designed ACC will enable us to control for confounding variables such as social support and expected outcomes, thus allowing us to determine whether elements specific to MBCT lead to its salutary effects (Aim 1). Previous MBCT studies have largely relied on self-report measurement methodologies, limiting valid conclusions about the nature of MBCT. Further, few studies have examined the mechanisms underlying effects of MBCT on depressive symptoms and relapse. Theoretical considerations and preliminary empirical evidence suggest emotional, physiological, and cognitive functioning to be promising mechanisms of MBCT. Therefore, the investigators propose to assess each of these potential mechanisms of MBCT using self-report, autonomic physiological, and reaction time tasks (Aim 2). Collectively, these aims are expected to strengthen the evidence base for MBCT while cultivating a scientific model for its effects and mechanisms on decreasing depressive symptoms and depression relapse rates.","other_id":"F32AT004879-01A2","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  must comprehend English well\r\n\r\n          -  be 18-55 years of age\r\n\r\n          -  meet enhanced DSM-IV criteria for remission of MDD, recurrent and have a history of\r\n             three or more previous episodes of DSM-IV major depression in the absence of a history\r\n             of mania or hypomania\r\n\r\n          -  at least one of those episodes was within the past two years\r\n\r\n          -  participant must be in remission and if on antidepressant medication (ADM), they must\r\n             be on a stable dose with no change in type or amount for past 12 weeks or participants\r\n             must be off ADM at T1 for at least the preceding 12 weeks\r\n\r\n          -  have, at screening assessment, residual depressive symptoms indicated by a Beck\r\n             Depression Inventory-II (BDI-II;[72]) score between 6-19.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  bipolar disorder\r\n\r\n          -  schizophrenia or borderline personality disorder\r\n\r\n          -  current suicidal thoughts and/or suicide attempt in last two months\r\n\r\n          -  current anxiety disorder if it constitutes the predominant aspect of the clinical\r\n             presentation and requires primary treatment not offered in the project\r\n\r\n          -  substance abuse or dependence within last three months\r\n\r\n          -  dementia or subnormal intellectual potential\r\n\r\n          -  current obsessive-compulsive disorder\r\n\r\n          -  current eating disorder\r\n\r\n          -  history of previous mindfulness training or more than eight lifetime sessions of CBT\r\n\r\n          -  current use of psychotherapy or counseling\r\n      ","sponsor":"University of Denver","sponsor_type":"Other","conditions":"Major Depressive Disorder|Recurrent","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Mindfulness Based Cognitive Therapy"},{"intervention_type":"Behavioral","name":"Behavioral: Health Enhancement Program"}],"outcomes":[{"outcome_type":"primary","measure":"Depression Relapse","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Depressive Symptoms","time_frame":"1 Year"}]}
{"nct_id":"NCT01945216","start_date":"2010-07-08","enrollment":3317,"brief_title":"Alogliptin Tablets Special Drug Use Surveillance \"Type 2 Diabetes Mellitus: Monotherapy/Combination Therapy With -GI\"","official_title":"Alogliptin Tablets Special Drug Use Surveillance \"Type 2 Diabetes Mellitus: Monotherapy/Combination Therapy With -GI\"","primary_completion_date":"2015-10-31","study_type":"Observational","rec_status":"Completed","completion_date":"2015-10-31","last_update":"2019-11-19","description":"The purpose of this study is to determine the safety and efficacy of long-term treatment with alogliptin (Nesina) in patients with type 2 diabetes mellitus who responded inadequately to diet therapy and exercise therapy alone, or a combination of diet therapy, exercise therapy, and -glucosidase inhibitor. In addition, examining the safety and efficacy of alogliptin in patients with renal impairment, information on the appropriate dosage of alogliptin according to the severity of impaired renal function should be collected.","other_id":"121-011","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","population":"Patients with type 2 diabetes mellitus who have been examined at a medical institution","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with type 2 diabetes mellitus who have not adequately responded to any one of\r\n             the following therapies:\r\n\r\n               1. Diet therapy and exercise therapy alone\r\n\r\n               2. In addition to diet therapy and exercise therapy, use of -glucosidase inhibitor\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients contraindicated for Nesina\r\n\r\n               1. Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes\r\n                  mellitus (these patients require prompt adjustment of hyperglycemia by fluid\r\n                  infusion and insulin, and hence use of Nesina is not appropriate.)\r\n\r\n               2. Patients with severe infection, pre- or post-operative patients, or patients with\r\n                  serious traumatic injury (blood glucose control by insulin injection is desirable\r\n                  for these patients, and hence use of Nesina is not appropriate.)\r\n\r\n               3. Patients with a history of hypersensitivity to any ingredient of Nesina\r\n      ","sponsor":"Takeda","sponsor_type":"Industry","conditions":"Type 2 Diabetes Mellitus Who Have Been Examined at a Medical Institution","interventions":[{"intervention_type":"Drug","name":"Drug: Alogliptin","description":"Alogliptin tablets"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants Who Experience at Least One Adverse Events","time_frame":"Up to Month 36"},{"outcome_type":"primary","measure":"Change From Baseline in Glycosylated Hemoglobin (HbA1c)","time_frame":"Baseline, Months 1, 3, 6, 12, 18, 24, 30, 36 and final assessment (up to Month 36)","description":"The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at month 36 relative to baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Fasting Blood Glucose","time_frame":"Baseline, Months 1, 3, 6, 12, 18, 24, 30, 36 and final assessment (up to Month 36)","description":"The change in the value of fasting blood glucose collected at month 36 relative to baseline."}]}
{"nct_id":"NCT01081041","start_date":"2010-06-30","phase":"Phase 2","enrollment":187,"brief_title":"A Study in Head and Neck Cancer","official_title":"A Randomized, Double-Blind, Phase 2 Safety Study of Cetuximab, Using ImClone Versus Boehringer Ingelheim Manufacturing Processes, in Combination With Cisplatin or Carboplatin and 5-Fluorouracil in the First-Line Treatment of Patients With Locoregionally Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck","primary_completion_date":"2013-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-09-30","last_update":"2019-09-25","description":"This study will begin with a 30 participant lead-in part: these 30 participants will receive cetuximab manufactured by ImClone on a weekly basis in combination with other chemotherapy drugs [cisplatin or carboplatin plus 5-fluorouracil (5-FU)] administered every 3 weeks. After 18 weeks, participants who benefit from this treatment may continue to receive cetuximab once-weekly until progression of the disease, an unacceptable side effect occurs, participants withdraw consent, or the study is closed. In the second part of this study, 200 participants will be randomized in 2 arms: - 100 participants will receive commercial cetuximab manufactured by ImClone (Group A) - 100 participants will receive cetuximab manufactured by Boehringer Ingelheim (Group B). All these 200 participants will receive other chemotherapy drugs (cisplatin or carboplatin plus 5-FU) administered every 3 weeks. After 18 weeks, participants who benefit from this treatment may continue to receive cetuximab once-weekly until progression of the disease, an unacceptable side effect occurs, participants withdraw consent, or the study is closed.","other_id":"13611","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Head and neck cancer that was confirmed by tissue biopsy or cytology\r\n\r\n          -  Disease not suitable for local therapy\r\n\r\n          -  Measurable or evaluable disease\r\n\r\n          -  Karnofsky performance status (KPS) score of at least 70\r\n\r\n          -  Organs are functioning well (bone marrow reserve, liver and kidney)\r\n\r\n          -  Life expectancy of at least 12 weeks\r\n\r\n          -  Signed informed consent document\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Receiving another investigational medication within the last 30 days\r\n\r\n          -  Prior chemotherapy, except if given as part of a multimodal treatment for locally\r\n             advanced head and neck cancer that was completed more than 4 months prior to study\r\n             entry.\r\n\r\n          -  Nasopharyngeal carcinoma\r\n\r\n          -  Previous treatment with monoclonal antibody therapy or other signal transduction\r\n             inhibitors or epidermal growth factor receptor (EGFR) targeting therapy except for\r\n             prior cetuximab treatment given as part of a multimodal treatment for locally advanced\r\n             head and neck cancer that was completed more than 4 months prior to study entry.\r\n\r\n          -  Uncontrolled high blood pressure\r\n\r\n          -  Heart disease or had a heart attack within the last year\r\n\r\n          -  Currently have an infection that requires for you to take an IV antibiotic\r\n\r\n          -  Currently receiving other therapies for your cancer, such as chemotherapy, radiation\r\n             therapy, immunotherapy, and hormonal therapy\r\n\r\n          -  Medical or psychological condition that would not permit the participant to complete\r\n             the study or sign informed consent\r\n\r\n          -  Known drug abuse (with the exception of alcohol abuse)\r\n\r\n          -  Known allergic reaction against any of the components of the study treatment\r\n\r\n          -  Second primary malignancy that is clinically detectable at the time of consideration\r\n             for study enrollment\r\n\r\n          -  Have had another type of cancer within the last 2 years\r\n\r\n          -  You are currently pregnant or breastfeeding\r\n\r\n          -  You are considering becoming pregnant or fathering a child\r\n      ","sponsor":"Eli Lilly and Company","sponsor_type":"Industry","conditions":"Head and Neck Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Cetuximab","description":"Administered intravenously"},{"intervention_type":"Drug","name":"Drug: Cisplatin","description":"Administered intravenously"},{"intervention_type":"Drug","name":"Drug: Carboplatin","description":"Administered intravenously"},{"intervention_type":"Drug","name":"Drug: 5-Fluorouracil","description":"Administered intravenously"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs); Data Analysis Cut-Off: September 27, 2013","time_frame":"Part 2: Baseline to end of combination therapy (up to 18 weeks)","description":"September 27, 2013 is the date when data was last collected for the primary endpoint. Prior to this date, the manufacturing process for the BI-manufactured cetuximab was changed necessitating the need to switch participants to US commercial cetuximab. All other components of their treatment regimen remained unchanged and participants stayed in their original reporting group. Therefore, the number of participants in the BI-manufactured cetuximab treatment arm who had TEAEs includes TEAEs while participants received BI-manufactured and US-commercial cetuximab. Using September 27 cut-off, the analysis of TEAEs is confounded by the switch from BI-manufactured to US commercial cetuximab. TEAEs were defined as serious and other non-serious AEs that occurred or worsened after study treatment (regardless of causality). TEAE information for Safety Lead-In group available in Reported Adverse Events module which is summary of serious and other non-serious AEs regardless of causality."},{"outcome_type":"primary","measure":"Number of Participants Who Had TEAEs; Data Analysis Cut-Off: January 23, 2013","time_frame":"Part 2: Baseline to end of combination therapy or date first participant switched to US commercial cetuximab (up to 18 weeks)","description":"January 23, 2013 is the date when the first participant in the BI-manufactured cetuximab treatment arm switched to US commercial cetuximab due to changes in the manufacturing process for the BI-manufactured cetuximab necessitating the need to switch participants to US commercial cetuximab. Each participant who switched treatments received at least 2 cycles of BI-manufactured cetuximab before switching. All other components of their treatment regimen remained unchanged. The number of participants who had TEAEs during combination therapy is reported. Using January 23 cut-off, data is un-confounded by lack of BI-manufactured cetuximab. TEAEs were defined as serious and other non-serious adverse events (AEs) that occurred or worsened after study treatment (regardless of causality). TEAE information for Safety Lead-in group available in Reported Adverse Event module which is summary of serious and other non-serious AEs regardless of causality."},{"outcome_type":"secondary","measure":"Overall Survival (OS)","time_frame":"Parts 1 and 2: Randomization to Date of Death from any Cause (Up to 36.3 Months)","description":"OS was defined as duration from the date of randomization to the date of death from any cause. For each participant not known to have died as of the 23 October 2014 data cutoff date for the analysis, OS was censored at the date last known to be alive. In addition, any participants on Arm B who was switched from BI-manufactured cetuximab to ImClone-manufactured cetuximab was censored at the time of the switch."},{"outcome_type":"secondary","measure":"Progression-Free Survival (PFS)","time_frame":"Parts 1 and 2: Randomization to Progression of Disease or Death from any Cause (Up to 32.7 Months)","description":"PFS was defined as duration from the date of randomization to the first date of objective progressive disease (PD) or death from any cause. For each participant who was not known to have died or to have had objective PD as of the 23 October 2014 data cutoff date for the analysis, PFS was censored at the date of the participant's last complete tumor assessment prior to that cutoff date. In addition, any participant in Arm B who was switched from BI-manufactured cetuximab to ImClone-manufactured cetuximab was censored at the time of the switch."},{"outcome_type":"secondary","measure":"Percentage of Participants Having a Confirmed Best Response of Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])","time_frame":"Parts 1 and 2: Randomization to Progression of Disease (Up to 32.7 Months)","description":"Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version [v]1.0) criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Percentage of participants with a confirmed CR or PR=(number of participants whose best overall response was CR or PR)/(number of participants treated)*100."},{"outcome_type":"secondary","measure":"Number of Participants With Anti-Cetuximab Antibodies","time_frame":"Day 1, Week 1 of Cycles 3 and 5 (postbaseline samples were collected prior to infusion)."},{"outcome_type":"secondary","measure":"Percentage of Participants Having a Best Response of CR, PR, or Stable Disease (SD) - Disease Control Rate (DCR)","time_frame":"Parts 1 and 2: Randomization to Progression of Disease (Up to 32.7 Months)","description":"Response was defined using RECIST, v1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Progressive Disease (PD) was defined as having at least a 20% increase in the sum of the longest diameter of target lesions. Stable Disease (SD) was defined as small changes that did not meet the above criteria."},{"outcome_type":"secondary","measure":"Maximum Serum Concentration (Cmax) of Cetuximab Following 400 mg/m² Cetuximab Dosing","time_frame":"Part 2: Cycle 1, Day 1: 0 hours [(h); immediately postdose], 1 h, 2 h, and 24 h postdose","description":"The Cmax of cetuximab following 400 mg/m² cetuximab dosing during Part 2 of the study is reported. As specified in the protocol, pharmacokinetics (PK) samples were not collected during Part 1 of the study, Safety Lead-In or during Part 2 monotherapy."},{"outcome_type":"secondary","measure":"Cmax of Cetuximab at Steady State","time_frame":"Part 2: Weekly from Cycle 1, Week 3 through Cycle 3, Week 3: 0 h (immediately postdose), 24 h, 96 h, and 168 h postdose","description":"A total of 4 samples were collected at various times during combination therapy, from the third dose of 250 mg/m^2 cetuximab in Cycle 1 (Week 3) through the final dose in Cycle 3 (Week 3) and used to report Cmax of cetuximab at steady state during Part 2 of the study. As specified in the protocol, PK samples were not collected during Part 1 of the study, Safety Lead-In, or during Part 2 monotherapy."},{"outcome_type":"secondary","measure":"Area Under the Concentration Curve (AUC) of Cetuximab at Steady State","time_frame":"Part 2: Weekly from Cycle 1, Day 1 through Cycle 3, Week 3: 0 h (immediately postdose), 24 h, 96 h, and 168 h postdose","description":"A total of 4 samples were collected during combination therapy, from the first dose of 250 mg/m^2 cetuximab in Cycle 1 (Day 1) through the final dose in Cycle 3 (Week 3) and used to report AUC of cetuximab at steady state during Part 2 of the study. As specified in the protocol, PK samples were not collected during Part 1 of the study, Safety Lead-In, or during Part 2 monotherapy."}]}
{"nct_id":"NCT01838291","start_date":"2010-06-30","enrollment":294,"brief_title":"Active Drug Surveillance Program of Ferriprox Use","official_title":"Active Drug Surveillance Program of Ferriprox Use","primary_completion_date":"2013-04-30","study_type":"Observational","rec_status":"Completed","completion_date":"2013-04-30","last_update":"2013-04-24","description":"Observational, open label, prospective, multi-center, post-marketing drug surveillance program.","other_id":"LA35-PM","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","population":"Apporximately 300 patients who have recently started treatment with treatment with\r\n        Ferriprox (less than one month prior to enrolment) or who are naive to Ferriprox treatment.","criteria":"\n        Main Inclusion Criteria:\r\n\r\n          -  Patients who started Ferriprox therapy less than one month or are to initiate\r\n             Ferriprox therapy at the time of enrolment into the program.\r\n\r\n        Main Exclusion Criteria:\r\n\r\n          -  Patients treated with Ferriprox for more than one month prior to enrolment.\r\n      ","sponsor":"ApoPharma","sponsor_type":"Industry","conditions":"Transfusional Iron Overload","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Evaluation of dose of Ferriprox, and if applicable concurrent chelator(s) in newly treated patients.","time_frame":"Baseline to 12 Months","description":"Evaluation of dose of Ferriprox includes the frequency of administration of chelator(s)."},{"outcome_type":"primary","measure":"Evaluation of regimen of Ferriprox administration, and if applicable concurrent chelator(s) in newly treated patients.","time_frame":"Baseline to 12 Months","description":"Evaluation of how Ferriprox is prescribed/received by the patient: as monotherapy, simultaneous with deferoxamine, alternate with deferoxamine, simultaneous with deferasirox, alternate with deferasirox."},{"outcome_type":"secondary","measure":"Assessment of the beneficial effects of Ferriprox based on the characterization of its use in clinical practice.","time_frame":"Baseline to 12 Months","description":"Beneficial effects of Ferriprox will be assessed based on the changes in: serum ferritin and cardiac iron concentration as assessed by MRI T2*."},{"outcome_type":"secondary","measure":"Assessment of the adverse effects of Ferriprox based on the characterization of its use in clinical practice.","time_frame":"Baseline to 12 Months","description":"Adverse effects of Ferriprox will be assessed based on: frequency of absolute neutrophil count (ANC) monitoring, occurrence of neutropenia or agranulocytosis and occurrence of other adverse events (AEs) or adverse drug reactions (ADRs)."}]}
{"nct_id":"NCT01158274","start_date":"2010-06-30","phase":"Phase 1","enrollment":30,"brief_title":"RO4929097 and Capecitabine in Treating Patients With Refractory Solid Tumors","official_title":"A Phase 1 Study of RO4929097 (NSC749225) in Combination With Capecitabine in Refractory Solid Tumors","primary_completion_date":"2012-08-31","study_type":"Interventional","rec_status":"Completed","last_update":"2014-11-07","description":"This phase I clinical trial is studying the side effects and best dose of RO4929097 when given together with capecitabine in treating patients with refractory solid tumors. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving RO4929097 together with chemotherapy may kill more tumor cells.","other_id":"NCI-2012-02918","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients must have histologically or cytologically confirmed advanced or metastatic\r\n             solid tumor; patients with lymphoma will be eligible\r\n\r\n          -  Patients must have measurable disease, defined as at least one lesion that can be\r\n             accurately measured in at least one dimension (longest diameter to be recorded) as >=\r\n             20 mm with conventional techniques or as >= 10 mm with spiral CT scan\r\n\r\n          -  Patients must be at least 4 weeks since prior chemotherapy, 6 weeks if the last\r\n             regimen included BCNU or mitomycin C; prior radiation is allowed as long as the\r\n             radiation was completed 4 weeks prior to study treatment and no more than 35% of\r\n             marrow irradiated\r\n\r\n          -  Life expectancy of greater than 3 months\r\n\r\n          -  ECOG performance status =< 2 (Karnofsky >= 60%)\r\n\r\n          -  Hemoglobin >= 9 g/dL\r\n\r\n          -  Leukocytes >= 3,000/mcL\r\n\r\n          -  Absolute neutrophil count >= 1,500/mcL\r\n\r\n          -  Platelets >= 100,000/mcL\r\n\r\n          -  Total bilirubin within normal institutional limits\r\n\r\n          -  AST (SGOT)/ALT (SGPT) =< 2.5 X institutional upper limit of normal\r\n\r\n          -  Creatinine within normal institutional limits OR creatinine clearance >= 60\r\n             mL/min/1.73 m^2 for patients with creatinine levels above institutional normal; a 24\r\n             hour urine collection and creatinine clearance can be measured if indicated\r\n\r\n          -  Treated, stable brain metastases are allowed; patients must be four weeks from\r\n             radiation with stable brain imaging and off any medications used to treat brain\r\n             metastases, excepting those anti-epileptics not metabolized by cytochrome P450\r\n\r\n          -  Women of childbearing potential and men must use two forms of contraception (i.e.,\r\n             barrier contraception and one other method of contraception) at least 4 weeks prior to\r\n             study entry, for the duration of study participation, and for at least 12 months\r\n             post-treatment; should a woman become pregnant or suspect she is pregnant while she or\r\n             her partner are participating in this study and for 12 months after study\r\n             participation, the patient should inform the treating physician immediately\r\n\r\n          -  Women of childbearing potential are required to have a negative serum pregnancy test\r\n             (with a sensitivity of at least 25 mIU/mL) within 10-14 days and within 24 hours prior\r\n             to the first dose of RO4929097 (serum or urine); a pregnancy test (serum or urine)\r\n             will be administered every 4 weeks if their menstrual cycles are regular or every 2\r\n             weeks if their cycles are irregular while on study within the 24-hour period prior to\r\n             the administration of RO4929097; a positive urine test must be confirmed by a serum\r\n             pregnancy test; prior to dispensing RO4929097, the investigator must confirm and\r\n             document the patient's use of two contraceptive methods, dates of negative pregnancy\r\n             test, and confirm the patient's understanding of the teratogenic potential of\r\n             RO4929097\r\n\r\n          -  Female patients of childbearing potential are defined as follows:\r\n\r\n               -  Patients with regular menses\r\n\r\n               -  Patients, after menarche with amenorrhea, irregular cycles, or using a\r\n                  contraceptive method that precludes withdrawal bleeding\r\n\r\n               -  Women who have had tubal ligation\r\n\r\n          -  Female patients may be considered NOT to be of childbearing potential for the\r\n             following reasons:\r\n\r\n               -  The patient has undergone total abdominal hysterectomy with bilateral\r\n                  salpingo-oophorectomy or bilateral oophorectomy\r\n\r\n               -  The patient is medically confirmed to be menopausal (no menstrual period) for 24\r\n                  consecutive months\r\n\r\n               -  Pre-pubertal females. The parent or guardian of young female patients who have\r\n                  not yet started menstruation should verify that menstruation has not begun. If a\r\n                  young female patient reaches menarche during the study, then she is to be\r\n                  considered as a woman of childbearing potential from that time forward\r\n\r\n          -  Patients must demonstrate an ability to understand and the willingness to sign a\r\n             written informed consent document\r\n\r\n          -  Preclinical studies indicate that RO4929097 is a substrate of CYP3A4 and inducer of\r\n             CYP3A4 enzyme activity; caution should be exercised when dosing RO4929097 concurrently\r\n             with CYP3A4 substrates, inducers, and/or inhibitors; furthermore, patients who are\r\n             taking concurrent medications that are strong inducers/inhibitors or substrates of\r\n             CYP3A4 should be switched to alternative medications to minimize any potential risk;\r\n             if such patients cannot be switched to alternative medications, they will be\r\n             ineligible to participate in this study\r\n\r\n          -  PART 2A (MTD EXPANSION COLORECTAL CANCER):\r\n\r\n          -  For this cohort patients must have histologically or cytologically documented advanced\r\n             or metastatic colorectal cancer; patients must have had at least one prior\r\n             chemotherapy regimen for their disease but no more than 2\r\n\r\n          -  All 5 patients in this cohort must be willing and able to have tumor biopsies\r\n             performed as part of the correlative studies associated with this trial\r\n\r\n          -  PART 2B (MTD EXPANSION BREAST CANCER):\r\n\r\n          -  For this cohort, patients must have histologically or cytologically documented\r\n             advanced or metastatic breast cancer\r\n\r\n          -  Patient must be HER2/neu negative; HER2 negative will be defined as HER2 neither\r\n             over-expressed or amplified; HER2 will be considered NOT over-expressed if the tumor\r\n             stains as 0 or 1+ for HER2 by immunohistochemistry (IHC); if the IHC for HER2 is 2+,\r\n             fluorescence in-site hybridization (FISH) ratio must be less than 2 to be considered\r\n             NOT amplified; any tumor for which only FISH was performed must have a ratio of less\r\n             than 2 to be considered NOT amplified\r\n\r\n          -  All 5 patients in this breast cancer cohort must be willing and able to have tumor\r\n             biopsies performed as part of the correlative studies associated with this trial\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients may not be receiving any other investigational agents\r\n\r\n          -  History of allergic reactions attributed to compounds of similar chemical or biologic\r\n             composition to RO4929097 or capecitabine\r\n\r\n          -  Patients taking medications with narrow therapeutic indices that are metabolized by\r\n             cytochrome P450 (CYP450), including warfarin sodium (Coumadin) are ineligible\r\n\r\n          -  Patients with malabsorption syndrome or other condition that would interfere with\r\n             intestinal absorption; patients must be able to swallow tablets\r\n\r\n          -  Patients who are serologically positive for Hepatitis A, B or C, or have a history of\r\n             liver disease, other forms of hepatitis or cirrhosis are ineligible\r\n\r\n          -  Patients with uncontrolled hypocalcemia, hypomagnesemia, hyponatremia,\r\n             hypophosphatemia or hypokalemia defined as less than the lower limit of normal for the\r\n             institution, despite adequate electrolyte supplementation are excluded from this\r\n             study; note: it is acceptable to use corrected calcium when interpreting calcium\r\n             levels\r\n\r\n          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active\r\n             infection, symptomatic congestive heart failure, unstable angina pectoris, and a\r\n             history of torsades de pointes or other significant cardiac arrhythmia other than\r\n             chronic, stable atrial fibrillation, or psychiatric illness/social situations that\r\n             would limit compliance with study requirements\r\n\r\n          -  Pregnant women are excluded from this study; breastfeeding should be discontinued\r\n\r\n          -  HIV-positive patients, who are not on anti-retroviral therapy but have CD4 cells less\r\n             than 200, should be excluded; HIV-positive patients are eligible if they are on HAART\r\n             (highly active anti-retroviral therapy) which are not CYP3A4 substrates, inducers\r\n             and/or inhibitors and meet all other criteria\r\n\r\n          -  Cardiovascular: baseline QTcF > 450 msec\r\n\r\n          -  Patients with known dihydropyrimidine dehydrogenase (DPD) deficiency enzyme are\r\n             excluded\r\n\r\n          -  Patients who have not recovered to < CTCAE grade 2 toxicities related to prior therapy\r\n             are not eligible to participate in this study\r\n\r\n          -  A requirement for antiarrhythmics or other medications known to prolong QTc\r\n\r\n          -  PART2B (MTD EXPANSION BREAST CANCER):\r\n\r\n          -  Patients may not have had more than 1 prior cytotoxic chemotherapy for metastatic\r\n             disease; prior endocrine or immunotherapy regimens for metastatic disease will not be\r\n             counted as cytotoxic\r\n      ","sponsor":"National Cancer Institute (NCI)","sponsor_type":"NIH","conditions":"Stage IIIB Breast Cancer|Stage IIIC Breast Cancer|Adult Grade III Lymphomatoid Granulomatosis|Adult Nasal Type Extranodal NK/T-cell Lymphoma|AIDS-related Diffuse Large Cell Lymphoma|AIDS-related Diffuse Mixed Cell Lymphoma|AIDS-related Diffuse Small Cleaved Cell Lymphoma|AIDS-related Immunoblastic Large Cell Lymphoma|AIDS-related Lymphoblastic Lymphoma|AIDS-related Peripheral/Systemic Lymphoma|AIDS-related Primary CNS Lymphoma|AIDS-related Small Noncleaved Cell Lymphoma|Anaplastic Large Cell Lymphoma|Angioimmunoblastic T-cell Lymphoma|Cutaneous B-cell Non-Hodgkin Lymphoma|Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue|HER2-negative Breast Cancer|HIV-associated Hodgkin Lymphoma|Intraocular Lymphoma|Male Breast Cancer|Nodal Marginal Zone B-cell Lymphoma|Post-transplant Lymphoproliferative Disorder|Primary Central Nervous System Hodgkin Lymphoma|Primary Central Nervous System Non-Hodgkin Lymphoma|Recurrent Adult Burkitt Lymphoma|Recurrent Adult Diffuse Large Cell Lymphoma|Recurrent Adult Diffuse Mixed Cell Lymphoma|Recurrent Adult Diffuse Small Cleaved Cell Lymphoma|Recurrent Adult Grade III Lymphomatoid Granulomatosis|Recurrent Adult Hodgkin Lymphoma|Recurrent Adult Immunoblastic Large Cell Lymphoma|Recurrent Adult Lymphoblastic Lymphoma|Recurrent Adult T-cell Leukemia/Lymphoma|Recurrent Breast Cancer|Recurrent Colon Cancer|Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma|Recurrent Grade 1 Follicular Lymphoma|Recurrent Grade 2 Follicular Lymphoma|Recurrent Grade 3 Follicular Lymphoma|Recurrent Mantle Cell Lymphoma|Recurrent Marginal Zone Lymphoma|Recurrent Mycosis Fungoides/Sezary Syndrome|Recurrent Rectal Cancer|Recurrent Small Lymphocytic Lymphoma|Small Intestine Lymphoma|Splenic Marginal Zone Lymphoma|Stage III Adult Burkitt Lymphoma|Stage III Adult Diffuse Large Cell Lymphoma|Stage III Adult Diffuse Mixed Cell Lymphoma|Stage III Adult Diffuse Small Cleaved Cell Lymphoma|Stage III Adult Hodgkin Lymphoma|Stage III Adult Immunoblastic Large Cell Lymphoma|Stage III Adult Lymphoblastic Lymphoma|Stage III Adult T-cell Leukemia/Lymphoma|Stage III Colon Cancer|Stage III Cutaneous T-cell Non-Hodgkin Lymphoma|Stage III Grade 1 Follicular Lymphoma|Stage III Grade 2 Follicular Lymphoma|Stage III Grade 3 Follicular Lymphoma|Stage III Mantle Cell Lymphoma|Stage III Marginal Zone Lymphoma|Stage III Mycosis Fungoides/Sezary Syndrome|Stage III Rectal Cancer|Stage III Small Lymphocytic Lymphoma|Stage IIIA Breast Cancer|Stage IV Adult Burkitt Lymphoma|Stage IV Adult Diffuse Large Cell Lymphoma|Stage IV Adult Diffuse Mixed Cell Lymphoma|Stage IV Adult Diffuse Small Cleaved Cell Lymphoma|Stage IV Adult Hodgkin Lymphoma|Stage IV Adult Immunoblastic Large Cell Lymphoma|Stage IV Adult Lymphoblastic Lymphoma|Stage IV Adult T-cell Leukemia/Lymphoma|Stage IV Breast Cancer|Stage IV Colon Cancer|Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma|Stage IV Grade 1 Follicular Lymphoma|Stage IV Grade 2 Follicular Lymphoma|Stage IV Grade 3 Follicular Lymphoma|Stage IV Mantle Cell Lymphoma|Stage IV Marginal Zone Lymphoma|Stage IV Mycosis Fungoides/Sezary Syndrome|Stage IV Rectal Cancer|Stage IV Small Lymphocytic Lymphoma|Unspecified Adult Solid Tumor, Protocol Specific|Waldenstrm Macroglobulinemia","interventions":[{"intervention_type":"Drug","name":"Drug: gamma-secretase/Notch signalling pathway inhibitor RO4929097","description":"Given orally"},{"intervention_type":"Drug","name":"Drug: capecitabine","description":"Given orally"},{"intervention_type":"Other","name":"Other: laboratory biomarker analysis","description":"Correlative studies"}],"outcomes":[{"outcome_type":"primary","measure":"MTD of RO4929097 and capecitabine, defined as that dose level at which less than one-third of patients experience a dose-limiting toxicity (DLT) graded according to NCI CTCAE version 4.0 (Part 1)","time_frame":"Up to 21 days"},{"outcome_type":"primary","measure":"Incidence of adverse events graded according to NCI CTCAE version 4.0 (Part 1)","time_frame":"Up to 30 days after completion of study treatment","description":"Possible adverse events will be reported in tabular format. To determine the severity of the reaction for adverse event reporting, the NCI CTCAE version 4.0 will be used."},{"outcome_type":"primary","measure":"Incidence of adverse events graded according to NCI CTCAE version 4.0 (Parts 2a and 2b)","time_frame":"Up to 24 months","description":"Possible adverse events will be reported in tabular format. To determine the severity of the reaction for adverse event reporting, the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be used."},{"outcome_type":"secondary","measure":"Confirmed anti-tumor response rate validated by the RECIST (Part 1)","time_frame":"Up to 30 days after completion of study treatment","description":"Responses will be summarized using descriptive statistics presented in tabular format. Furthermore, two-sided 95% confidence intervals for the proportions of subjects with a confirmed anti-tumor response will be computed, while adjusting for multiplicity."},{"outcome_type":"secondary","measure":"Changes in the expression of Notch1 signaling pathway members (Part 1)","time_frame":"From baseline to 30 days after completion of study treatment","description":"Relative and absolute changes will be calculated for each patient and results will be summarized by means and standard deviations. Paired t-tests will be used to compare baseline and post-study values in expression levels."},{"outcome_type":"secondary","measure":"Pharmacokinetics of the combination of RO4929097 and capecitabine, including Cmax, Tmax, AUC, t1/2, and CL (Part 1)","time_frame":"Baseline on day 1 of course 1; baseline and 1, 2, 3, 4, 8, 12, 16, and 24 hours on days 3 and 10 of course 1; and baseline on day 1 of all subsequent courses","description":"PK parameters will be summarized by using means, standard deviations and ranges. PK parameters between patients with a response (partial or complete) will be compared to PK parameters of patients with no response using a nonparametric Wilcoxon Rank Sum test."},{"outcome_type":"secondary","measure":"PFS (Parts 2a and 2b)","time_frame":"Up to 24 months","description":"Presented in a tabular format."},{"outcome_type":"secondary","measure":"OS (Part 2a and 2b)","time_frame":"Number of days from the day of first RO4929097 and capecitabine administration to the patient's death, assessed up to 24 months","description":"Presented in a tabular format."},{"outcome_type":"secondary","measure":"Overall response rate (Parts 2a and 2b)","time_frame":"Up to 24 months","description":"Confirmed anti-tumor response rate will be validated by RECIST. Responses will be summarized using descriptive statistics presented in tabular format."}]}
{"nct_id":"NCT01781013","start_date":"2010-06-30","phase":"N/A","enrollment":1485,"brief_title":"Diabetes-Depression Care-management Adoption Trial","official_title":"Care Management Technology to Facilitate Depression Care in Safety Net Diabetes Clinics","primary_completion_date":"2013-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-09-30","last_update":"2014-12-05","description":"The specific aims of the proposed study are to: 1. Develop the innovative depression care management technology, including the speech recognition technology for automated monitoring and patient prompts over time, automatic integration of the responses into the patient registry, and evidence-based decision-support algorithms for care actions; 2. Conduct the quasi-experiment in eight Los Angeles County Department of Health Services (LAC-DHS) clinics to test the interventions; 3. Use mixed-method evaluation to assess the extent of the implementation of the interventions, the acceptance to the providers and to the patients, and the impact on adoption of depression screening and treatment management over time, utilization, and cost of healthcare services, and patient health outcomes; and 4. Conduct a cost-effectiveness analysis of the three study arms. Successful completion of the study will demonstrate which Comparative Effectiveness Research (CER) adoption strategies are successful and why, their comparative cost-effectiveness, as well as which strategies are successful under which circumstances to inform system-wide implementation of same. Hypotheses of the Proposed Study The following are the main hypotheses of the study: 1. There will be statistically significant difference in the adoption of depression care screening and management over time among the three study groups. 1.1. The adoption rate will be Technology-supported care (TC) > Supported Care (SC) > Usual Care (UC). 2. There will be statistically significant difference in the depression symptom reduction, and better functional status, and quality of life among the three study groups. 2.1. The difference between the TC and the SC will not be statistically significant, but both will be greater than the UC group. 3. There will be statistically significant difference in the diabetes care process and outcomes among the three study groups. 3.1. The difference between the TC and the SC will not be statistically significant, but both will be greater than the UC group. 4. There will also be statistically significant differences in healthcare utilization among the three study groups, with least utilization in the TC group where the greatest level of technology is applied. 5. Of the three groups compared, the TC group will be the most cost-effective approach for accelerating adoption of the CER depression care results.","other_id":"RFA-AE-10-001","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  age equal to or greater than 18 years\r\n\r\n          -  receiving primary care at DHS safety net clinics\r\n\r\n          -  having a current diagnosis of type 2 diabetes mellitus (non-gestational).\r\n\r\n          -  have a working telephone or cellular phone.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  current suicidal ideation;\r\n\r\n          -  inability to speak either English or Spanish;\r\n\r\n          -  a score of 2 or greater on the CAGE (4M) alcohol assessment;\r\n\r\n          -  having schizophrenia, schizoaffective disorder, manic-depressive, or needing lithium;\r\n\r\n          -  and cognitive impairment precluding ability to give informed consent or participating\r\n             in the intervention, i.e., Short Portable Mental Status Questionnaire(SPMSQ) score of\r\n             6 or more errors.\r\n\r\n        Provider and administrator inclusion criteria are: practicing or managing at one of the\r\n        eight study sites; involved with diabetes or depression care\r\n\r\n        No specific exclusion criteria will be applied to providers and administrators.\r\n      ","sponsor":"University of Southern California","sponsor_type":"Other","conditions":"Depression|Diabetes Mellitus","interventions":[{"intervention_type":"Other","name":"Other: Technology-supported care","description":"The depression care-management technology that will interact with patients is the Automated Speech Recognition (ASR) for remote monitoring data collection. The ASR will use automated telephone calls to reach out to patients to repeat depression screening using PHQ-9, triggered either by calendar date or upcoming appointments, and to remind patients of their appointments in pre-determined time. In addition, the ASR will apply a structured script to conduct automatic follow-up with patients regarding their depression treatment adherence and side effects in order to provide data to help primary medical providers promptly and optimally adapt treatment. The ASR script will also include structured relapse prevention prompts. For providers and administrators, the depression care-management technology aimed to improve their workflow regarding depression care is Enhanced Disease Registry (EDR).."}],"outcomes":[{"outcome_type":"primary","measure":"Change from baseline in depression outcome at 6-months","time_frame":"6-months from enrollment","description":"Depression is measured using depression scales Patient Health Questionnaire (PHQ)-9. Major depression is classified as PHQ-9>=10."},{"outcome_type":"secondary","measure":"Change from baseline in diabetes self-care score in 6 months","time_frame":"6 months from enrollment","description":"Diabetes self-care is measured using the Toolbert diabetes self-care scale."},{"outcome_type":"other","measure":"Change from baseline in physical functional status in 6 months","time_frame":"6 months from enrollment","description":"Physical functional status is measured using the physical component score of the SF-12 scale"},{"outcome_type":"other","measure":"Change from baseline in mental functional status in 6 months","time_frame":"6 months from enrollment","description":"Mental functional status is measured using the mental component score of the SF-12 scale"},{"outcome_type":"other","measure":"Change from baseline in physical functional status in 12 months","time_frame":"12 months from enrollment","description":"Physical functional status is measured using the physical component score of the SF-12 scale"},{"outcome_type":"other","measure":"Change from baseline in mental functional status in 12 months","time_frame":"12 months after enrollment","description":"Mental functional status is measured using the mental component score of the SF-12 scale"},{"outcome_type":"other","measure":"Change from baseline of mental health-related functional impairment in 12 months","time_frame":"12 months from enrollment","description":"Assessed using the Sheehan disability scale"},{"outcome_type":"other","measure":"Change from baseline of mental health-related functional impairment in 6 months","time_frame":"6 months from enrollment","description":"Assessed using the Sheehan disability scale"},{"outcome_type":"other","measure":"Change from baseline in depression outcome in 12 months","time_frame":"12 months from enrollment","description":"Depression is measured using depression scales Patient Health Questionnaire (PHQ)-9. Major depression is classified as PHQ-9>=10."},{"outcome_type":"other","measure":"Change from baseline in diabetes self-care score in 12 months","time_frame":"12 months after enrollment","description":"Diabetes self-care is measured using Toolbert diabetes self-care scale."},{"outcome_type":"other","measure":"Change from baseline of diabetes symptoms in 12 months","time_frame":"12 months from enrollment","description":"Assessed using the Whitty-9 diabetes symptoms scale"},{"outcome_type":"other","measure":"Change from baseline of diabetes symptoms in 6 months","time_frame":"6 months from enrollment","description":"Assessed using the Whitty-9 diabetes symptoms scale"},{"outcome_type":"other","measure":"Change from baseline in percentage of patients who receive HbA1C lab test in 12 months","time_frame":"12 months from enrollment","description":"This is one of our diabetes care processes measure. We are going to analyze the percentage of patients who receive the requisite lab tests, including HbA1C, microalbumin, and lipid panel."},{"outcome_type":"other","measure":"Change from baseline in percentage of patients who receive the lipid panel lab test in 12 months","time_frame":"12 months from enrollment","description":"This is one of our diabetes care processes measure. We are going to analyze the percentage of patients who receive the requisite lab tests, including HbA1C, microalbumin, and lipid panel."},{"outcome_type":"other","measure":"Change from baseline in percentage of patients who receive microalbumin lab test in 12 months","time_frame":"12 months from enrollment","description":"This is one of our diabetes care processes measure. We are going to analyze the percentage of patients who receive the requisite lab tests, including HbA1C, microalbumin, and lipid panel."},{"outcome_type":"other","measure":"Change from baseline in percentage of patients who receive HbA1C lab test in 6 months","time_frame":"6 months from enrollment","description":"This is one of our diabetes care processes measure. We are going to analyze the percentage of patients who receive the requisite lab tests, including HbA1C, microalbumin, and lipid panel."},{"outcome_type":"other","measure":"Change from baseline in percentage of patients who receive the lipid panel lab test in 6 months","time_frame":"6 months from enrollment","description":"This is one of our diabetes care processes measure. We are going to analyze the percentage of patients who receive the requisite lab tests, including HbA1C, microalbumin, and lipid panel"},{"outcome_type":"other","measure":"Change from baseline in percentage of patients who receive microalbumin lab test in 6 months","time_frame":"6 months from enrollment","description":"This is one of our diabetes care processes measure. We are going to analyze the percentage of patients who receive the requisite lab tests, including HbA1C, microalbumin, and lipid panel."},{"outcome_type":"other","measure":"Change from baseline in percentage of patients whose HbA1C is in control in 12 months","time_frame":"12 months from enrollment","description":"This is part of our diabetes outcome measure. We would like to know the percentage of patients whose HbA1C is in control pre- and post-intervention. HbA1C is considered controlled if it is <7%."},{"outcome_type":"other","measure":"Change from baseline in percentage of patients whose microalbumin is in control in 12 months","time_frame":"12 months from enrollment","description":"This is part of our diabetes outcome measure. We would like to know the percentage of patients whose microalbumin is in control pre- and post-intervention. Microalbumin is considered controlled if it is <30 microg/mg."},{"outcome_type":"other","measure":"Change from baseline in percentage of patients whose total cholesterol is in control in 12 months","time_frame":"12 months from enrollment","description":"This is part of our diabetes outcome measure. We would like to know the percentage of patients whose total cholesterol is in control pre- and post-intervention. Total cholesterol is considered controlled if it is <200mg/dL."},{"outcome_type":"other","measure":"Change from baseline in percentage of patients whose LDL cholesterol is in control in 12 months","time_frame":"12 months from enrollment","description":"This is part of our diabetes outcome measure. We would like to know the percentage of patients whose LDL cholesterol is in control pre- and post-intervention. LDL cholesterol is considered controlled if it is <100mg/dL."},{"outcome_type":"other","measure":"Change from baseline in percentage of patients whose HDL cholesterol is in control in 12 months","time_frame":"12 months from enrollment","description":"This is part of our diabetes outcome measure. We would like to know the percentage of patients whose HDL cholesterol is in control pre- and post-intervention. HDL cholesterol is considered controlled if it is <40mg/dL."},{"outcome_type":"other","measure":"Change from baseline in percentage of patients whose triglycerides is in control in 12 months","time_frame":"12 months from enrollment","description":"This is part of our diabetes outcome measure. We would like to know the percentage of patients whose triglycerides is in control pre- and post-intervention. Triglycerides is considered controlled if it is >200mg/dL."},{"outcome_type":"other","measure":"Change from baseline in percentage of patients whose HbA1C is in control in 6 months","time_frame":"6 months from enrollment","description":"This is part of our diabetes outcome measure. We would like to know the percentage of patients whose HbA1C is in control pre- and post-intervention. HbA1C is considered controlled if it is <7%."},{"outcome_type":"other","measure":"Change from baseline in percentage of patients whose microalbumin is in control in 6 months","time_frame":"6 months from enrollment","description":"This is part of our diabetes outcome measure. We would like to know the percentage of patients whose microalbumin is in control pre- and post-intervention. Microalbumin is considered controlled if it is <20mg/L."},{"outcome_type":"other","measure":"Change from baseline in percentage of patients whose total cholesterol is in control in 6 months","time_frame":"6 months from enrollment","description":"This is part of our diabetes outcome measure. We would like to know the percentage of patients whose total cholesterol is in control pre- and post-intervention. Total cholesterol is considered controlled if it is >240mg/dL"},{"outcome_type":"other","measure":"Change from baseline in percentage of patients whose LDL cholesterol is in control in 6 months","time_frame":"6 months from enrollment","description":"This is part of our diabetes outcome measure. We would like to know the percentage of patients whose LDL cholesterol is in control pre- and post-intervention. LDL cholesterol is considered controlled if it is >160mg/dL."},{"outcome_type":"other","measure":"Change from baseline in percentage of patients whose HDL cholesterol is in control in 6 months","time_frame":"6 months from enrollment","description":"This is part of our diabetes outcome measure. We would like to know the percentage of patients whose HDL cholesterol is in control pre- and post-intervention. HDL cholesterol is considered controlled if it is >60mg/dL."},{"outcome_type":"other","measure":"Change from baseline in percentage of patients whose triglycerides is in control in 6 months","time_frame":"6 months from enrollment","description":"This is part of our diabetes outcome measure. We would like to know the percentage of patients whose triglycerides is in control pre- and post-intervention. Triglycerides is considered controlled if it is <150mg/dL"},{"outcome_type":"other","measure":"Change from baseline to 12 months in number of outpatient visits during the past 6 months","time_frame":"12 months from enrollment","description":"This is part of our utilization measure. We would like to know the number of outpatient visits during 6-months before baseline and between 6- and 12-months after enrollment."},{"outcome_type":"other","measure":"Change from baseline to 6 months in number of outpatient visits during the past 6 months","time_frame":"6 months from enrollment","description":"This is part of our utilization measure. We would like to know the number of outpatient visits during 6-months before baseline and during the 6-months after enrollment."},{"outcome_type":"other","measure":"Change from baseline to 12 months in percentage of patients who were hospitalized during the past 6 months","time_frame":"12 months from enrollment","description":"This is part of our utilization measure. We would like to know the percentage of hospitalized patients during 6-months before baseline and between 6- and 12-months after enrollment."},{"outcome_type":"other","measure":"Change from baseline to 6 months in percentage of hospitalized patients during the past 6 months","time_frame":"6 months from enrollment","description":"This is part of our utilization measure. We would like to know the percentage of hospitalized patients during 6-months before baseline and during the 6-months after enrollment."},{"outcome_type":"other","measure":"Change from baseline to 12 months in percentage of patients with ER visits during the past 6 months","time_frame":"12 months from enrollment","description":"This is part of our utilization measure. We would like to know the percentage of patients with ER visits during 6-months before baseline and between 6- and 12-months after enrollment."},{"outcome_type":"other","measure":"Change from baseline to 6 months in percentage of patients with ER visits during the past 6 months","time_frame":"6 months from enrollment","description":"This is part of our utilization measure. We would like to know the percentage of patients with ER visits during 6-months before baseline and during the 6-months after enrollment."},{"outcome_type":"other","measure":"Difference between cost of care management in the intervention group and the control groups over a 12-month period per patient","time_frame":"12 months","description":"Cost of care management includes automated phone calls, provider time, costs associated with reviewing tasks and follow-ups."},{"outcome_type":"other","measure":"Change from baseline to 12 months in percentage of patients satisfied with care received for diabetes","time_frame":"12 months from enrollment","description":"Measured by the percentage of patients who answered \"satisfied\" or \"very satisfied\" to the question \"How satisfied / dissatisfied are you with the overall health care available to you for your diabetes?\" (with a 5-point Likert scale response option)"},{"outcome_type":"other","measure":"Change from baseline to 6 months in percentage of patients satisfied with care received for diabetes","time_frame":"6 months from enrollment","description":"Measured by the percentage of patients who answered \"satisfied\" or \"very satisfied\" to the question \"How satisfied / dissatisfied are you with the overall health care available to you for your diabetes?\" (with a 5-point Likert scale response option)"},{"outcome_type":"other","measure":"Change from baseline to 12 months in percentage of patients satisfied with care received for depression","time_frame":"12 months from enrollment","description":"Measured by the percentage of patients who answered \"satisfied\" or \"very satisfied\" to the question \"How satisfied / dissatisfied are you with the clinical help received with your emotional problem?\" (with a 5-point Likert scale response option)"},{"outcome_type":"other","measure":"Change from baseline to 6 months in percentage of patients satisfied with care received for depression","time_frame":"6 months from enrollment","description":"Measured by the percentage of patients who answered \"satisfied\" or \"very satisfied\" to the question \"How satisfied / dissatisfied are you with the clinical help received with your emotional problem?\" (with a 5-point Likert scale response option)"}]}
{"nct_id":"NCT01163149","start_date":"2010-06-30","phase":"Phase 2","enrollment":19,"brief_title":"Safety and Efficacy Study of Asfotase Alfa in Adolescents and Adults With Hypophosphatasia (HPP)","official_title":"A Randomized, Open-Label, Multicenter, Multinational, Dose-Ranging, Concurrent Control Study of the Safety, Efficacy, Pharmacokinetic of ENB-0040 (Human Recombinant Tissue Nonspecific Alkaline Phosphatase Fusion Protein) in Adolescents and Adults With Hypophosphatasia (HPP)","primary_completion_date":"2016-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-06-30","last_update":"2019-03-13","description":"This clinical trial was conducted to study hypophosphatasia (HPP), a bone disorder caused by gene mutations or changes. These gene mutations cause low levels of an enzyme needed to harden bone. The purpose of this study was to test the safety and efficacy of two doses of the study drug called asfotase alfa as compared to a control group to see effects on adolescents and adults with HPP.","other_id":"ENB-009-10","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":13,"maximum_age":65,"population":"","criteria":"\n        Inclusion criteria:\r\n\r\n        Patients must meet all of the following inclusion criteria to be eligible for participation\r\n        in this study:\r\n\r\n          -  Patients or their legal representative(s) must provide written informed consent prior\r\n             to undergoing any study-related procedures\r\n\r\n          -  Patients must be  13 and  65 years of age at the time of study enrollment\r\n\r\n          -  Female patients of childbearing potential and sexually mature males must agree to use\r\n             a medically acceptable form of birth control; for the purposes of this study, females\r\n             are considered of non-childbearing potential if they are surgically sterile (i.e.,\r\n             have undergone a total hysterectomy, bilateral salpingo-oophorectomy or tubal\r\n             ligation) or are post-menopausal, defined as having complete cessation of menstruation\r\n             for at least 1 year after 45 years of age\r\n\r\n          -  Patients must have a pre-established clinical diagnosis of HPP as indicated by:\r\n\r\n               -  Serum alkaline phosphatase (ALP) below the age-adjusted normal range\r\n\r\n               -  Plasma PLP at least twice the upper limit of normal (no vitamin B6 administered\r\n                  for at least 1 week prior to determination)\r\n\r\n               -  Evidence of osteopenia or osteomalacia on skeletal radiographs\r\n\r\n          -  Patients must have osteomalacia on bone biopsy, characterized by an MLT z-score of +2\r\n             or more (results from ENB-001-08 may be used)\r\n\r\n          -  Patients must be willing to comply with study procedures and the visit schedule\r\n\r\n        Exclusion criteria:\r\n\r\n        Patients will be excluded from participation in this study if they meet any of the\r\n        following exclusion criteria:\r\n\r\n          -  Women who are pregnant or lactating\r\n\r\n          -  History of sensitivity to tetracycline\r\n\r\n          -  Serum calcium or phosphate levels below the normal range\r\n\r\n          -  Serum 25(OH) vitamin D below 20 ng/mL\r\n\r\n          -  Serum creatinine or parathyroid hormone (PTH) levels above the upper limit of normal\r\n\r\n          -  Medical condition, serious intercurrent illness, or other extenuating circumstance\r\n             that, in the opinion of the Investigator, may significantly interfere with study\r\n             compliance, including all prescribed evaluations and follow-up activities\r\n\r\n          -  Orthopedic surgery within 12 months prior to study entry that may interfere with the\r\n             ability to perform functional assessments for the study\r\n\r\n          -  Prior treatment with bisphosphonates within 2 years of study entry for any length of\r\n             time or for more than 2 years at any time point; for patients with prior\r\n             bisphosphonate use that is allowed, the bone resorption markers serum C-telopeptide\r\n             and urine N-telopeptide or urine deoxypyridinoline must also be within the normal\r\n             range or elevated to be eligible for study participation\r\n\r\n          -  Treatment with PTH within 6 months prior to the start of asfotase alfa administration\r\n\r\n          -  Participation in an interventional or investigational drug study within 30 days prior\r\n             to study participation\r\n      ","sponsor":"Alexion Pharmaceuticals","sponsor_type":"Industry","conditions":"Hypophosphatasia","interventions":[{"intervention_type":"Drug","name":"Drug: asfotase alfa","description":"Cohort 1: Daily SC injections of 0.3 mg/kg asfotase alfa (total of 2.1 mg/kg/week)"},{"intervention_type":"Drug","name":"Drug: asfotase alfa","description":"Cohort 2: Daily SC injections of 0.5 mg/kg Asfotase Alfa (3.5 mg/kg/week total)"}],"outcomes":[{"outcome_type":"primary","measure":"Change From Baseline to Week 24 for Plasma Pyridoxal-5' Phosphate (PLP)","time_frame":"Baseline, Week 24","description":"Blood samples were collected to evaluate the effect of asfotase alfa on reduction in plasma pyridoxal-5' phosphate (PLP)"},{"outcome_type":"primary","measure":"Change From Baseline to Week 24 for Plasma Inorganic Pyrophosphate (PPi)","time_frame":"Baseline, Week 24","description":"Blood samples were collected to evaluate the effect of asfotase alfa on reduction in plasma inorganic pyrophosphate (PPi)"},{"outcome_type":"primary","measure":"Safety and Tolerability of Asfotase Alfa","time_frame":"Up to 288 weeks exposure to asfotase alfa","description":"The safety and tolerability of daily subcutaneous (SC) injections of asfotase alfa was assessed by routine monitoring of patients for treatment-emergent adverse events (TEAEs) and injection-associated reactions (IARs)."},{"outcome_type":"secondary","measure":"Change From Baseline in Bone Mineral Content (BMC) as Measured by Dual-energy X-ray Absorptiometry (DXA)","time_frame":"Baseline, every 24 weeks through Week 96, then every 48 weeks until Week 288.","description":"A DXA scan was performed to evaluate bone mineral content (BMC) of the spine, hip, and whole body during the primary (first 24 weeks) and extension treatment periods (up to 288 weeks)."},{"outcome_type":"secondary","measure":"Change From Baseline in Bone Mineral Density (BMD) as Measured by Dual-energy X-ray Absorptiometry (DXA)","time_frame":"Baseline, every 24 weeks through Week 96, then every 48 weeks until Week 288.","description":"A DXA scan was performed to evaluate bone bone mineral density (BMD) of the spine, hip, and whole body during the primary (first 24 weeks) and extension treatment periods (up to 288 weeks)."},{"outcome_type":"secondary","measure":"Change in Walking Ability as Measured by the Six-Minute Walk Test (6MWT)","time_frame":"Baseline, Week 24 (primary treatment period) and up to 288 weeks of asfotase alfa exposure","description":"The patient was instructed to walk the length of a pre-measured hallway for 6 minutes. The primary measurement was distance walked (in meters)."},{"outcome_type":"secondary","measure":"Change From Baseline in HPP-related Osteomalacia as Measured by Trans-iliac Crest Bone Biopsy: Osteoid Volume/Bone Volume","time_frame":"Baseline, Week 24 (Control group), and Week 48 (Asfotase alfa groups).","description":"A trans-iliac crest bone biopsy was performed to quantify changes from Baseline in histomorphometric parameters relevant for evaluation of osteomalacia severity, including Osteoid Volume/Bone Volume (%). The difference in time under observation between asfotase alfa groups (Week 48) and control group (Week 24) resulted from study design, ie, control subjects transitioned to active treatment after the Week 24 visit."},{"outcome_type":"secondary","measure":"Change From Baseline in HPP-related Osteomalacia as Measured by Trans-iliac Crest Bone Biopsy: Osteoid Thickness","time_frame":"Baseline, Week 24 (Control group), and Week 48 (Asfotase alfa groups).","description":"A trans-iliac crest bone biopsy was performed to quantify changes from Baseline in histomorphometric parameters relevant for evaluation of osteomalacia severity, including Osteoid Thickness (um). The difference in time under observation between asfotase alfa groups (Week 48) and control group (Week 24) resulted from study design, ie, control subjects transitioned to active treatment after the Week 24 visit."},{"outcome_type":"secondary","measure":"Change From Baseline in HPP-related Osteomalacia as Measured by Trans-iliac Crest Bone Biopsy: Mineralization Lag Time","time_frame":"Baseline, Week 24 (Control group), and Week 48 (Asfotase alfa groups).","description":"A trans-iliac crest bone biopsy was performed to quantify changes from Baseline in histomorphometric parameters relevant for evaluation of osteomalacia severity, including Mineralization Lag Time (days). The difference in time under observation between asfotase alfa groups (Week 48) and control group (Week 24) resulted from study design, ie, control subjects transitioned to active treatment after the Week 24 visit."}]}
{"nct_id":"NCT01306370","start_date":"2010-06-30","phase":"Phase 3","enrollment":172,"brief_title":"Fibrin Glue or Tranexamic Acid for Total Knee Arthroplasty","official_title":"Prevention of Postoperative Blood Loss: Randomised Unicentric Parallel Clinical Trial That Assess the Efficacy of Fibrin Glue and Tranexamic Acid in Surgical Patients With a Total Knee Arthroplasty.","primary_completion_date":"2011-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-11-30","last_update":"2013-08-28","description":"Objectives: a) Principal: To assess if the fibrin glue or the tranexamic acid reduce less than 20% the blood losses with respect to the habitual haemostasia in patients with arthroplasty total of knee. Secondaries: To assess the treatment safety. To perform a cost- analyses. Methods: Randomized, unicentric, and parallel clinical trial with four comparative groups: Tissucol (fibrin glue), fibrin glue manufactured by the Cryoseal system (Banc de Sang i Teixits de Catalunya), tranexamic acid and habitual haemostasia. N of participant centres: 1. Random allocation will be centralised. Main outcome: Blood losses (ml) in the post-operatory period collected by the habitual drain system. Secondary outcomes: Proportion of patients with blood transfusion, complications of surgery wound, pre and post-operative haemoglobin, units of blood transfused, post-operative mortality, days of hospital stay, safety of interventions assessed. Size sample calculation: The number needed of patients is 172 (43 per group) to demonstrate a 20% difference in the post-operative blood losses between the treatments assessed and the habitual haemostasia, with a statistical power of 80% and a 0.05 bilateral alpha, and a 20% of withdrawals. Statistical analysis: The investigators will perform a comparison of outcomes through the \"t\" test, the Mann-Whitney test of chi square, depending of the evaluated outcomes, quantitative or ordinals or qualitative, respectively. The software used will be Statistical Package for the Social Sciences (SPSS) version 17.","other_id":"2009-017804-95","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Total knee arthroplasty\r\n\r\n          -  The patient consent to participate\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Intolerance drugs to the study or to bovine protein (aprotinin)\r\n\r\n          -  Antecedent of thromboembolic disease\r\n\r\n          -  Patient with cardiac alterations of the rhythm\r\n\r\n          -  Patients with valvular cardiac prosthesis\r\n\r\n          -  Patients with pro-thrombotic alterations of coagulation\r\n\r\n          -  Treatment with anticonceptive drugs\r\n      ","sponsor":"Fundaci Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau","sponsor_type":"Other","conditions":"Knee Arthropathy","interventions":[{"intervention_type":"Drug","name":"Drug: Tranexamic Acid","description":"Two dosage during the surgical intervention: the first dosage 15-30' before the leg ischemia and the second dosage at 60 -90' after the first dosage.\r\nEach dosage: 2 ampoules of 500mg/5 mL/ampoule"},{"intervention_type":"Drug","name":"Drug: Fibrin glue","description":"Topical administration, before to close the surgical wound. Dosage: 2 mL."},{"intervention_type":"Biological","name":"Biological: Fibrin glue","description":"Topical administration, before to close the surgical wound."},{"intervention_type":"Other","name":"Other: Habitual haemostasis","description":"The surgical habitual haemostasis."}],"outcomes":[{"outcome_type":"primary","measure":"Postoperative blood loss (mL)","time_frame":"During the first 48h after the surgical intervention","description":"Blood loss (mL) by the surgical wound collected by drain systems."},{"outcome_type":"secondary","measure":"Percentage of patients that need a postoperative blood transfusion","time_frame":"During the first postoperative week"},{"outcome_type":"secondary","measure":"Percentage of patients with surgical wound infection","time_frame":"During the first postoperative month"},{"outcome_type":"secondary","measure":"Percentage of patients with surgical wound dehiscence","time_frame":"During the first postoperative month"},{"outcome_type":"secondary","measure":"Percentage of patients with re-intervention by wound complications","time_frame":"During the first postoperative month"},{"outcome_type":"secondary","measure":"Incidence of deep venous thrombosis","time_frame":"During the first postoperative week"},{"outcome_type":"secondary","measure":"Pain of surgical wound","time_frame":"During the first postoperative week"},{"outcome_type":"secondary","measure":"Units of blood transfusion","time_frame":"During the first postoperative week"},{"outcome_type":"secondary","measure":"hospital length stay","time_frame":"Days"},{"outcome_type":"secondary","measure":"Mortality","time_frame":"During the first postoperative month"}]}
{"nct_id":"NCT02488161","start_date":"2010-06-30","enrollment":2600,"brief_title":"Factors Related to Adverse Events in Colorectal Cancer","official_title":"Risk Factors of Adverse Outcomes at Short and Medium Term, and Development of Predictive Models, in Patients With Colorectal Cancer. IRYSS-coordinated Multicenter Study","primary_completion_date":"2012-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2015-06-30","last_update":"2016-08-24","description":"Coordinated multi-center project with several complementary goals in each one of the sub-projects included. Objectives: 1.To determine risk factors of death, or major complications in the short term; 2.To determine risk factors of death, tumor recurrence, major complications, readmission or deterioration of quality of life in the mid term; 3.Evaluation of patient reported outcomes from before the intervention to the end of the follow-up. 4.To study the role of immunohisto-chemistry markers in the prediction of similar adverse results. This sub-project (coordinator) will approach the determination of risk factors of death, tumor recurrence, major complications, readmission and deterioration of quality of medium term life (1-2 years). Methodology. Design: prospective cohort study with 2 years follow-up after the surgical intervention. Participant centers: 18 hospitals of 6 Autonomous Communities of all Spain. Patients diagnosed of colorectal cancer surgically intervened. Variables: pre-intervention, those of the hospital admission, sociodemographic, immunohisto-chemistry and clinical parameters, that could be in relation to the outcomes to study. Statistic analysis: a derivation sample will be created where the possible predicting parameters will be identified, by cancer of colon or rectum. Predictive models will be created with a good discriminative capacity. A validation of those models will be performed in a validation sub-sample. Logistic and Cox regression models will be used. Simulation models for the prediction of discreet events in the long term will be used.","other_id":"PS09/00314","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"This prospective cohort study included patients drawn from 22 hospitals belonging to the\r\n        Spanish National Health Service (SNS), which covers the majority (99.8%) of the population\r\n        of Spain. All covered residents have free access to their primary care physician and to the\r\n        ED of the hospitals. All of the hospitals have similar technological and human resources.\r\n\r\n        Patients with a diagnosis of colon or rectum cancer attending the surgical services of any\r\n        of these hospitals to undergo surgery between June 2010 and December 2012 were informed of\r\n        the goals of the study and invited to voluntarily participate.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients were eligible for the study if they were included in the surgical waiting\r\n             list of one of the participating hospitals with a diagnosis of surgically resectable\r\n             colon or rectum cancer. Colon or rectum cancer diagnosis was based on\r\n             anatomopathological diagnosis after a biopsy by colonoscopy. Inclusion criteria were\r\n             having diagnosed with colon cancer (up to 15 cm above the anal margin) and rectum\r\n             (between the anal margin and 15 cm above it), where curative and / or palliative\r\n             surgery for treatment by first time were applied and who sign the informed consent to\r\n             participate in the study consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Exclusion criteria were colon or rectum in situ cancer, unresectable tumor, severe\r\n             mental or physical conditions which preclude the patient to respond to questionnaires,\r\n             terminal patients, patients unable to respond to questionnaires from any cause or who\r\n             do not give their consent to participate in the study.\r\n      ","sponsor":"Hospital Galdakao-Usansolo","sponsor_type":"Other","conditions":"Colorectal Cancer","interventions":[{"intervention_type":"Other","name":"Other: No intervention"}],"outcomes":[{"outcome_type":"primary","measure":"Mortality","time_frame":"up to five years"},{"outcome_type":"secondary","measure":"Number of participants with Readmission","time_frame":"up to five years"},{"outcome_type":"secondary","measure":"Number of participants with Reintervention","time_frame":"up to five years"},{"outcome_type":"secondary","measure":"Changes in health-related quality of life (in the questionnaires employed in the study)","time_frame":"up to five years"},{"outcome_type":"secondary","measure":"Number of participants with Complications","time_frame":"up to five years"},{"outcome_type":"secondary","measure":"Number of participants with Cancer recurrence","time_frame":"up to five years"}]}
{"nct_id":"NCT01896024","start_date":"2010-06-30","phase":"N/A","enrollment":85,"brief_title":"Effects of Motive-Oriented Therapeutic Relationship in the Early-Phase Treatment of Borderline Personality Disorder","primary_completion_date":"2013-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-04-30","last_update":"2014-12-02","description":"The present research aims at examining the effectiveness of a specific set of therapist relational interventions and attitudes, called the Motive-Oriented Therapeutic Relationship (MOTR), based on Plan Analysis (Caspar, 2007) in the early-phase treatment of patients diagnosed with Borderline Personality Disorder. The investigators intend to include N = 80 outpatients diagnosed with Borderline Personality Disorder, consulting at the Outpatient Personality Disorder Program of the Karl Jaspers Clinical Unit, in collaboration with the Institute of Psychotherapy, at the Department of Psychiatry-CHUV, University of Lausanne and in collaboration with the University of Berne, Switzerland. Patients are assigned by chance to two treatment conditions 1) Control condition (General Psychiatric Management; Gunderson & Links, 2008) and 2) MOTR-condition. The investigators hypothesize better results in the MOTR-condition, as compared to the control condition in terms of symptom reduction pre-post. The conduct of the study represents a significant contribution to the understanding and enhancement of relationship aspects in the treatment of patients diagnosed with Borderline Personality Disorder which may be of potential benefit for these patients.","other_id":"SNSF 100014-134562","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  DSM-IV Borderline Personality Disorder;\r\n\r\n          -  between 18 and 65 yrs of age\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  DSM-IV psychotic disorders,\r\n\r\n          -  mental retardation,\r\n\r\n          -  substance abuse in the forefront\r\n      ","sponsor":"University of Lausanne Hospitals","sponsor_type":"Other","conditions":"Borderline Personality Disorder","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Psychiatric Management"},{"intervention_type":"Behavioral","name":"Behavioral: Motive-oriented therapeutic relationship/Plan Analysis"}],"outcomes":[{"outcome_type":"primary","measure":"Outcome Questionnaire -45.2 (Lambert et al., 2004)","time_frame":"3 months","description":"pre- post- intervention in a randomized controlle trial; measure of symptom reduction over 3 months"},{"outcome_type":"secondary","measure":"Inventory of Interpersonal Problems (Horowitz et al., 1988)","time_frame":"3 months","description":"Measure of interpersonal problems after 3 months of therapy"},{"outcome_type":"other","measure":"Borderline Symptom List (Bohus, 2009)","time_frame":"3 months","description":"Symptom reduction of borderline symptoms over 3 months of treatment"}]}
{"nct_id":"NCT01180426","start_date":"2010-06-30","phase":"Phase 2","enrollment":30,"brief_title":"Extension Study With Tosedostat in Relapsed/Refractory Acute Myeloid Leukemia","official_title":"The TOPAZ Study: A Long-Term Extension Study in Elderly Subjects With Relapsed/Refractory Acute Myeloid Leukemia to Allow Continued Therapy With Tosedostat","primary_completion_date":"2013-06-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2013-06-30","last_update":"2012-02-15","description":"The purpose of this study is to evaluate the long-term efficacy and safety profile of tosedostat in elderly patients suffering from refractory or relapsed Acute Myeloid Leukemia.","other_id":"CHR-2797-045","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Signed, informed consent\r\n\r\n          -  Completion of Visit 11 in the OPAL Study (Month 6 Visit)\r\n\r\n          -  Investigator's opinion that the subject would benefit from continued therapy with\r\n             tosedostat.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any co-existing medical condition that in the Investigator's opinion will\r\n             substantially increase the risk associated with the subject's participation in the\r\n             study\r\n\r\n          -  Psychiatric disorders or altered mental status precluding understanding of the\r\n             informed consent process and/or completion of the necessary studies\r\n\r\n          -  Administration of any (other) investigational agent within 14 days of entry into\r\n             TOPAZ.\r\n      ","sponsor":"Chroma Therapeutics","sponsor_type":"Industry","conditions":"Acute Myeloid Leukemia","interventions":[{"intervention_type":"Drug","name":"Drug: CHR-2797","description":"120mg once daily oral for 48 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Safety and Tolerability of extended treatment with tosedostat","time_frame":"Protocol mandated visits every 12 weeks","description":"Primary outcome will be assessed using the following procedures/data:\r\nPhysical exams\r\nVital signs\r\nElectrocardiography\r\nLaboratory parameters (hematology, chemistry, urinalysis)\r\nAdverse events\r\nSerious adverse events"},{"outcome_type":"secondary","measure":"Efficacy of extended treatment with tosedostat","time_frame":"Protocol-mandated visits every 12 weeks","description":"The secondary outcome will be assessed using the following parameters:\r\nOverall survival\r\nRelapse-free survival\r\nEvent-free survival\r\nClinical responses (Complete Remission, Complete Remission with Incomplete Platelet Recovery, Morphological Leukemia-Free State, Partial Remission, Stable Disease, Progressive Disease) including best response and time to response\r\nDuration of clinical responses."}]}
{"nct_id":"NCT01109121","start_date":"2010-06-30","phase":"Phase 2","enrollment":112,"brief_title":"Tranilast Plus Allopurinol in Patients With Moderate to Severe Gout (TAnGO)","official_title":"A Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of Tranilast in Combination With Allopurinol in Patients With Moderate to Severe Gout (TAnGO)","primary_completion_date":"2010-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-01-31","last_update":"2011-01-06","description":"This Phase 2 study will be a multicenter, double-blind, randomized, active-comparator study to evaluate the safety and efficacy of tranilast in combination with allopurinol in patients with hyperuricemia and moderate to severe gout.","other_id":"A3007GT","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female, aged 18 to 80\r\n\r\n          -  Severe gout, demonstrated by 3 or more gout flares in the previous 12 months, or the\r\n             presence of at least one gout tophus or gouty arthritis\r\n\r\n          -  Hyperuricemia with a sUA 8.0 mg/dL\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnant or nursing\r\n\r\n          -  Known hypersensitivity to any of the components of tranilast or allopurinol\r\n\r\n          -  Known history of xanthinuria or kidney stones\r\n\r\n          -  Use of an investigational drug within 30 days\r\n\r\n          -  Presence of, or history of, cancer with the exception of completely excised,\r\n             non-metastatic squamous cell and basal cell carcinomas of the skin\r\n\r\n          -  Subject is planning or likely to require a surgical procedure during the study\r\n      ","sponsor":"Nuon Therapeutics, Inc.","sponsor_type":"Industry","conditions":"Moderate to Severe Gout|Hyperuricemia","interventions":[{"intervention_type":"Drug","name":"Drug: Combination 400","description":"Tranilast 300 mg QD; Allopurinol 400 mg QD"},{"intervention_type":"Drug","name":"Drug: Allopurinol","description":"Allopurinol 400 mg, QD"},{"intervention_type":"Drug","name":"Drug: Combination 600","description":"Tranilast, 300 mg QD; Allopurinol 600 mg QD"}],"outcomes":[{"outcome_type":"primary","measure":"Percent change from baseline in serum uric acid (sUA) levels","time_frame":"4 weeks"},{"outcome_type":"secondary","measure":"Proportion of subjects whose sUA levels fall below 6.0 mg/dL following 4 weeks of dosing","time_frame":"4 weeks"}]}
{"nct_id":"NCT01125644","start_date":"2010-05-31","phase":"Phase 3","enrollment":10,"brief_title":"Efficacy, Safety and Pharmacokinetics of SPK-843 in the Treatment of Pulmonary Mycosis","official_title":"Efficacy, Safety and Pharmacokinetics of SPK-843 in the Treatment of Pulmonary Mycosis. Open Label Phase III Clinical Study","primary_completion_date":"2011-10-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2011-12-31","last_update":"2011-06-08","description":"Recruitment of at least 10 adult patients (men and women) among individuals affected and admitted to the hospitals identified for the clinical study. All patients shall be between 18 and 75 years of age, with confirmed diagnosis of cryptococcosis or aspergillosis . During therapy (14 days) and examination (28 days), the patients will be subject to 7 doctor's visits (day 1,3,7,10,14,21, and 28).","other_id":"SPK-843-03/01","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:The following will be included in the study:\r\n\r\n          -  Patients with proven fungal etiology confirmed by mycological culture test and by\r\n             hystopathological exam (\"patients with definite diagnosis\"), or patients with fungal\r\n             infection of which is difficult to determine the etiological agent but with diagnosis\r\n             of deep mycosis based on blood testing for fungal infection and/or clinical\r\n             radiological examination, and/or endoscopic clinical examination, clinical\r\n             symptomatology (\"patients with clinical diagnosis\").\r\n\r\n          -  Patients being treated with other anti-fungal drugs (i) showing a poor response to the\r\n             treatment at least after 5 days of administration of the anti-fungal drug, (ii) that\r\n             have had an adverse reaction to the drug prejudicing its use, determining the\r\n             risk/benefit ratio unfavorable to the patient.\r\n\r\n          -  Patients between 18 and 75 years of age.\r\n\r\n          -  Patients able to understand the content of the Informed Consent and willing to\r\n             participate in the study.\r\n\r\n          -  Male and female patients.\r\n\r\n          -  Patients initially admitted to the hospitals identified for this clinical study.\r\n\r\n          -  Informed Consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients being treated with other anti-fungal drugs with improving clinical symptoms\r\n             or with an unclear clinical course.\r\n\r\n          -  Patients with intra-venous catheter and hospitalized with a diagnosis of fungemia but\r\n             without clinical symptomatology twelve hours after the removal of the catheter.\r\n\r\n          -  Patients with serious deep mycosis with low change of clinical efficacy (with a high\r\n             probability of death event), or with serious concomitant illnesses or with\r\n             complications, which may make difficult a safety evaluation of the treatment object of\r\n             this study.\r\n\r\n          -  Patients with a history of allergy to drugs like AMPH-B or with serious allergic\r\n             reactions to drugs (shock after administration of drugs different from antifungals).\r\n\r\n          -  Patients with serious hepatic, and/or renal, and/or cardiac failure or basic lung\r\n             disease or with functionality of the organs with the following criteria:\r\n\r\n               -  AST (GOT) or ALT (GPT) higher five (5) times the highest normal value or 200\r\n                  UI/L;\r\n\r\n               -  Blood creatinine higher than 2,0 mg/dl;\r\n\r\n               -  Proteinuira (qualitative test) 3+ or greater, or a total urinary excretion of\r\n                  proteins (quantitative test) of 3,5 g/day or higher;\r\n\r\n               -  Hyperkalemia or hypokalemia or with a basic level of sodium of 6,0 mEq/L or\r\n                  greater or less than 2,5 mEq/L;\r\n\r\n               -  Hyperlipidemia with a basic value of total cholesterol greater than 1,5 times the\r\n                  highest normal values or 300 mg/dl, triglycerides higher than twice the highest\r\n                  normal values or 300 mg/dl;\r\n\r\n               -  Patients that require the infusion of leucocytes;\r\n\r\n               -  Patients with arterial thrombosis or with serious coagulative dysfunctions;\r\n\r\n               -  Patients with diabetes mellitus associated with ketosis ;\r\n\r\n               -  Pregnant women or women who intend to become pregnant, women in purperium, or\r\n                  breast feeding;\r\n\r\n               -  Patients that participated in a clinical study (with any type of drugs, including\r\n                  anti-cancer drugs) or that have been recruited for observational clinical studies\r\n                  with pharmaceutical agents a month before the beginning of the treatment with\r\n                  SPK-843;\r\n\r\n               -  Patients who, according to the doctor, are not considered fit to be recruited in\r\n                  the study.\r\n      ","sponsor":"Proaparts srl","sponsor_type":"Industry","conditions":"Cryptococcosis or Aspergillosis Infections","interventions":[{"intervention_type":"Drug","name":"Drug: SPK-843","description":"SPK-843 is a semi-synthetic substance derived from Partricin A. 05 mg/Kg solution of SPK-843 in 10% intralipid will be administered i.v. in a hour for a treatment of 14 days"}],"outcomes":[{"outcome_type":"primary","measure":"Evaluation of the overall global clinical response","time_frame":"28 days","description":"Evaluation of the overall global clinical response based on secondary end points from 1 to 6 at the end of the therapy (Study day 14) and at the final visit at the end of the study - follow-up- (Study day 28) in comparison to the initial clinical state."},{"outcome_type":"secondary","measure":"Evaluate the safety in the administration of SPK-843.","time_frame":"28 days"}]}
{"nct_id":"NCT01073943","start_date":"2010-05-31","phase":"Phase 3","enrollment":603,"brief_title":"Investigation of PicoPrep Versus HalfLytely for Bowel Preparation for Colonoscopy - Day Before PicoPrep","official_title":"A Randomized, Assessor-Blinded, Multi-Center Study Investigating the Efficacy, Safety and Tolerability of \"Day Before\" PicoPrep for Oral Administration Versus HalfLytely for Colon Cleansing in Preparation for Colonoscopy","primary_completion_date":"2010-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-10-31","last_update":"2012-10-30","description":"Subjects undergoing an elective complete colonoscopy will randomly receive either PicoPrep: 2-sachets for oral solution in two divided doses given in the afternoon (first dose - sachet) and 6 hours later in the evening (second dose - sachet), given the day before the procedure or HalfLytely: for oral solution and two 5 mg Bisacodyl tablets, given the day before the procedure to evaluate its effectiveness, tolerability and safety.","other_id":"2009-02","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female, age 18 to 80 years, inclusive, being scheduled to undergo elective\r\n             colonoscopy\r\n\r\n          -  Female patients should be post menopausal (women  45yrs with no menstrual period for\r\n             at least 12 months without an alternative medical cause), be surgically sterile, or be\r\n             using medically approved contraception, throughout the trial period\r\n\r\n          -  Females of childbearing potential must undergo a pregnancy test at screening and again\r\n             at randomization\r\n\r\n          -  Subjects must have had more than or equal to 3 spontaneous bowel movements per week\r\n             for one month prior to the colonoscopy\r\n\r\n          -  Subjects should be willing, able and competent to complete the entire procedure and to\r\n             comply with study instructions\r\n\r\n          -  Written informed consent obtained prior to study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Acute surgical abdominal conditions (e.g. acute obstruction or perforation, etc.)\r\n\r\n          -  Active (acute/exacerbation of/severe/uncontrolled) Inflammatory Bowel Disease (IBD)\r\n\r\n          -  Any prior colorectal surgery, excluding appendectomy, hemorrhoid surgery or prior\r\n             endoscopic procedures\r\n\r\n          -  Colon disease (history of colonic cancer, toxic megacolon, toxic colitis, idiopathic\r\n             pseudo-obstruction, hypomotility syndrome)\r\n\r\n          -  Ascites\r\n\r\n          -  Gastrointestinal disorder (active ulcer, outlet obstruction, retention, gastroparesis,\r\n             ileus)\r\n\r\n          -  Upper gastrointestinal surgery (gastric resection, gastric banding, gastric by-pass)\r\n\r\n          -  Uncontrolled angina and/or Myocardial Infarction (MI) within last 3 months, Congestive\r\n             Heart Failure (CHF), or uncontrolled hypertension\r\n\r\n          -  Renal insufficiency (serum creatinine and potassium must be within normal limits)\r\n\r\n          -  Participation in an investigational study within 30 days prior to receiving study\r\n             medication (or within 60 days for investigational drugs with an elimination half-life\r\n             greater than 15 days)\r\n\r\n          -  Any clinically significant laboratory value at the screening, including pre-existing\r\n             electrolyte abnormality, based on clinical history that the Investigator feels may\r\n             affect the study evaluation\r\n\r\n          -  Hypersensitivity to active ingredients\r\n      ","sponsor":"Ferring Pharmaceuticals","sponsor_type":"Industry","conditions":"Bowel Preparation","interventions":[{"intervention_type":"Drug","name":"Drug: PicoPrep","description":"PicoPrep (sodium picosulfate, magnesium oxide and citric acid) powder for oral solution consisted of 2 pouches of powder administered in a divided dose. Each PicoPrep pouch was reconstituted by mixing the contents in a cup with 5 ounces of cold water. Subjects randomized to the PicoPrep group will begin treatment (1st sachet) one day before colonoscopy between 4:00 and 6:00 PM, and will complete the treatment (2nd sachet) at least 6 hours later, between 10:00 PM and 12:00 AM. Subjects will consume approximately (5) 8 oz. glasses of clear liquids following the first sachet administration in the afternoon and (3) 8 oz. glasses of clear liquids following the second sachet administration in the evening, one day before colonoscopy."},{"intervention_type":"Drug","name":"Drug: HalfLytely","description":"HalfLytely contains polyethylene glycol electrolyte solution (PEG-EL), sodium chloride, sodium bicarbonate and potassium chloride. The day prior to the colonoscopy procedure and after the first bowel movement or after 6 hours following administration of the bisacodyl tablets, whichever occurred first, subjects were to drink the 2 liter HalfLytely at a rate of one 8-ounce glass every 10 minutes. The entire solution was to be consumed."},{"intervention_type":"Drug","name":"Drug: bisacodyl","description":"Two 5 mg bisacodyl tablets were taken in the afternoon on the day prior to the colonoscopy procedure."}],"outcomes":[{"outcome_type":"secondary","measure":"Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed?","time_frame":"Day 2","description":"Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no"},{"outcome_type":"secondary","measure":"Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation","time_frame":"Day 2","description":"Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Fair, Poor, Bad"},{"outcome_type":"secondary","measure":"Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was","time_frame":"Day 2","description":"Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Tolerable, Poor, Bad"},{"outcome_type":"secondary","measure":"Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Ask Your Doctor for This Preparation Again if You Need Another Colonoscopy in the Future?","time_frame":"Day 2","description":"Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no"},{"outcome_type":"primary","measure":"Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist","time_frame":"Day 2","description":"Overall colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Aronchick scale. The Aronchick scale is a 4-step rating scale: inadequate, fair, good, and excellent. Excellent is defined as >90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization. Good is defined as >90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization."},{"outcome_type":"secondary","measure":"Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Ascending Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist","time_frame":"Day 2","description":"Cleansing of the ascending colon was assessed by a blinded gastroenterologist during the colonoscopy using the Ottawa scale, a 5-step rating scale: inadequate, poor, fair, good, and excellent. Excellent is defined as mucosal detail clearly visible; if fluid is present, it is clear and there is almost no stool residue. Good - some turbid fluid or stool residue but mucosal detail still visible; washing and suctioning is not necessary. Fair - turbid fluid or stool residue obscuring mucosal detail. However, mucosal detail becomes visible with suctioning and washing is not necessary."},{"outcome_type":"secondary","measure":"Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug?","time_frame":"Day 2","description":"Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: very easy, easy, tolerable, difficult, very difficult"},{"outcome_type":"secondary","measure":"Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Refuse the Same Preparation Again if it Were to be Prescribed to You in the Future?","time_frame":"Day 2","description":"Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no"},{"outcome_type":"secondary","measure":"Participants With Treatment-Emergent Adverse Events (TEAEs)","time_frame":"up to one month","description":"Counts of participants who had TEAEs are summarized in a variety of categories. Severity and relatedness to study drug are in the opinion of the investigator. Severity is rated on a 3-point scale: mild (awareness of signs or symptoms, but no disruption of usual activity), moderate (event sufficient to affect usual activity), and severe (inability to work or perform usual activities). Only severe TEAEs are summarized. Relatedness is assessed on a 4-point scale: unrelated, unlikely, possibly and probably. Both possibly and probably answers are reported as 'related' to study medication."},{"outcome_type":"other","measure":"Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist","time_frame":"Day 2","description":"Colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Ottawa scale, a 5-step rating scale: inadequate, poor, fair, good, and excellent. See Outcome #2 for definitions of the scale. Assessment of mid colon, recto-sigmoid, and overall (ascending, mid, and recto-sigmoid) cleansing is summarized here."}]}
{"nct_id":"NCT01132989","start_date":"2010-05-31","phase":"Phase 2","enrollment":10,"brief_title":"Open-label Pilot Study of Lenalidomide (Revlimid) as Adjuvant Treatment for Refractory Cutaneous T Cell Lymphoma","official_title":"Open-label Phase 2 Pilot Study of Lenalidomide (Revlimid) as Adjuvant Treatment for Refractory Cutaneous T Cell Lymphoma","primary_completion_date":"2010-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2010-12-31","last_update":"2010-05-28","description":"Patients with cutaneous T cell lymphoma experience refractory and progressive disease despite current treatment, necessitating chronic disease management. In addition, there needs to be greater emphasis on combination treatment, which correlates with increased response rate, more rapid onset of response, and decreased side effect profile compared to monotherapy. The goal for the use of Lenalidomide as an adjuvant treatment in patients with refractory cutaneous T cell lymphoma is to increase response rates, maintain a durable long-term response, relieve associated symptoms, and minimize toxic side effects.","other_id":"RevMM2009","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients  18 years of age (at the time of signing the informed consent).\r\n\r\n          -  Able to adhere to the study visit schedule and other protocol requirements.\r\n\r\n          -  Histologically confirmed mycosis fungoides or Sezary syndrome\r\n\r\n          -  Stage IB to IVB disease at screening (TNMB classification, see Protocol Attachment C)\r\n\r\n          -  Refractory disease after at least 2 prior therapies, which may include topicals,\r\n             phototherapy, bexarotene, interferon, and/or photopheresis. Patients may be currently\r\n             taking these medication and therapies may be used in combination.\r\n\r\n          -  Determined to have adequate baseline organ function defined as:\r\n\r\n        Hepatic: Total bilirubin  1.5 x upper limit of normal (ULN),AST and ALT  3.0 x ULN\r\n\r\n          -  Hematologic: Platelets  75 x 109/L\r\n\r\n          -  Absolute neutrophil count (ANC)  1.0 x 109/L,Hemoglobin  8.0 mg/dL\r\n\r\n          -  Renal: Creatinine clearance  30 ml/min (Appendix; Cockcroft-Gault formula)\r\n\r\n               -  At least 3 months since the initiation of any new CTCL treatments.\r\n\r\n               -  Stable or progressive disease despite current treatment regimen over the last 3\r\n                  months.\r\n\r\n               -  All study participants must be registered into the mandatory RevAssist program,\r\n                  and be willing and able to comply with the requirements of RevAssist.\r\n\r\n               -  Females of childbearing potential (FCBP) must have a negative serum or urine\r\n                  pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior\r\n                  to and again within 24 hours prior to prescribing lenalidomide (prescriptions\r\n                  must be filled within 7 days) and must either commit to continued abstinence from\r\n                  heterosexual intercourse or begin TWO acceptable methods of birth control, one\r\n                  highly effective method and one additional effective method AT THE SAME TIME, at\r\n                  least 28 days before she starts taking lenalidomide.\r\n\r\n               -  FCBP must also agree to ongoing pregnancy testing.\r\n\r\n               -  Men must agree to use a latex condom during sexual contact with a FCBP even if\r\n                  they have had a successful vasectomy.\r\n\r\n               -  A female of childbearing potential is a sexually mature woman who:\r\n\r\n                    1. has not undergone a hysterectomy or bilateral oophorectomy\r\n\r\n                    2. has not been naturally postmenopausal for at least 24 consecutive months\r\n                       (has had menses at any time in the preceding 24 consecutive months). See\r\n                       Appendix: Risks of Fetal Exposure, Pregnancy Testing Guidelines and\r\n                       Acceptable Birth Control Methods.\r\n\r\n               -  Disease free of prior malignancies for  5 years, with exception of basal cell\r\n                  and squamous cell carcinoma of the skin, or breast or cervix in situ carcinoma.\r\n\r\n               -  Expected survival of > 6 months.\r\n\r\n               -  Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation.\r\n                  Patients intolerant to aspirin may use warfarin or low molecular weight heparin.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any serious medical condition, laboratory abnormality, or psychiatric illness that\r\n             would prevent the subject from signing the informed consent form.\r\n\r\n          -  Female subjects who are pregnant, nursing, or planning pregnancy. Female subjects not\r\n             using at least 2 forms of birth control during the trial, unless the subject is\r\n             considered sterile (history of hysterectomy or postmenopausal with no menses for the\r\n             last 24 consecutive months).\r\n\r\n          -  History of deep venous thrombus (DVT) or pulmonary embolism (PE), unless currently on\r\n             anticoagulation therapy (warfarin or heparin).\r\n\r\n          -  Subjects receiving chemotherapeutic agents (or have received in the last 3 months),\r\n             vorinostat, or methotrexate.\r\n\r\n          -  Use of any other experimental drug or therapy within 28 days of baseline.\r\n\r\n          -  Known hypersensitivity to thalidomide.\r\n\r\n          -  History of erythema nodosum or desquamating rash while taking thalidomide or similar\r\n             drugs.\r\n\r\n          -  Any prior use of lenalidomide.\r\n\r\n          -  Known seropositive for or active viral infection with human immunodeficiency virus\r\n             (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are\r\n             seropositive because of hepatitis B virus vaccine are eligible..\r\n\r\n          -  Having a serious concomitant systemic disorder that could preclude the patient from\r\n             benefiting or completing the study based on discretion of the investigator.\r\n\r\n          -  Any condition or circumstance judged by the investigator that would render the\r\n             clinical trial detrimental or otherwise unsuitable for the patient's participation.\r\n\r\n          -  Neuropathy > grade 2\r\n      ","sponsor":"Florida Academic Dermatology Centers","sponsor_type":"Other","conditions":"Cutaneous T Cell Lymphoma","interventions":[{"intervention_type":"Drug","name":"Drug: Lenalidomide","description":"Lenalidomide Starting Dose Based on Renal Function at Study Entry Baseline Calculated Creatinine Clearance (by Cockcroft-Gault) Starting Lenalidomide Dose 60 ml/min 25mg daily on Days 1-21 of each 28-day cycle 30 and < 60 ml/min 10mg daily on Days 1-21 of each 28-day cycle"}],"outcomes":[{"outcome_type":"primary","measure":"Response rate(RR measurements are based on skin scoring using mSWAT (modified severity weighted assessment tool), Sezary cell count, and lymph node assessment.","time_frame":"1 year (average)","description":"The primary efficacy measure is the response rate (RR) based on skin scoring using mSWAT (modified severity weighted assessment tool), Sezary cell count, and lymph node assessment. Response rate is defined as the number of responders divided by the number of treated patients. A responder is defined as any patient who exhibits a confirmed complete or partial response.\r\n• Patients will be treated until progressive disease is demonstrated by ≥ 25% increase of SWAT score."},{"outcome_type":"secondary","measure":"The assessment of patient-reported changes of pruritus during treatment","time_frame":"1 year (average)","description":"Descriptive statistics will be calculated for pruritus relief. Both median duration of pruritus relief (for those exhibiting improvement in pruritus) and time to pruritus relief will be estimated."},{"outcome_type":"secondary","measure":"The assessment of the patient-reported improvement in quality of life during treatment","time_frame":"1 year (average)","description":"The validated DLQI patient self assessment questionnaire will be used to quantify the impact of skin disease on patients' quality of life"},{"outcome_type":"secondary","measure":"The assessment of the safety and tolerability of lenalidomide in the study population","time_frame":"1 year (average)","description":"The assessments of sezary cell count ,disease status using the mSWAT tool, lymphnode evaluations and adverse event incidences( associated with study medication )will be perfomed every four weeks to assess lenalidomide safety and tolerability."}]}
{"nct_id":"NCT01073930","start_date":"2010-05-31","phase":"Phase 3","enrollment":608,"brief_title":"Investigation of PicoPrep Versus HalfLytely for Bowel Preparation for Colonoscopy - Split Dose PicoPrep","official_title":"A Randomized, Assessor-Blinded, Multi-Center Study Investigating the Efficacy, Safety and Tolerability of \"Split-Dose\" PicoPrep for Oral Administration Versus HalfLytely for Colon Cleansing in Preparation for Colonoscopy","primary_completion_date":"2010-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-10-31","last_update":"2013-02-12","description":"Subjects undergoing an elective complete colonoscopy will randomly receive either PicoPrep: 2-sachets for oral solution in two divided doses given a night before (first dose - sachet) and approximately 5 hours prior to procedure (second dose - sachet) or HalfLytely: for oral solution and two 5 mg Bisacodyl tablets, given the day before the procedure to evaluate its effectiveness, tolerability and safety.","other_id":"2009-01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female, age 18 to 80 years, inclusive, being scheduled to undergo elective\r\n             colonoscopy\r\n\r\n          -  Female patients should be post menopausal (women  45yrs with no menstrual period for\r\n             at least 12 months without an alternative medical cause), be surgically sterile, or be\r\n             using medically approved contraception, throughout the trial period\r\n\r\n          -  Females of childbearing potential must undergo a pregnancy test at screening and again\r\n             at randomization\r\n\r\n          -  Subjects must have had more than or equal to 3 spontaneous bowel movements per week\r\n             for one month prior to the colonoscopy\r\n\r\n          -  Subjects should be willing, able and competent to complete the entire procedure and to\r\n             comply with study instructions\r\n\r\n          -  Written informed consent obtained prior to study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Acute surgical abdominal conditions (e.g. acute obstruction or perforation, etc.)\r\n\r\n          -  Active (acute/exacerbation of/severe/uncontrolled) Inflammatory Bowel Disease (IBD)\r\n\r\n          -  Any prior colorectal surgery, excluding appendectomy, hemorrhoid surgery or prior\r\n             endoscopic procedures\r\n\r\n          -  Colon disease (history of colonic cancer, toxic megacolon, toxic colitis, idiopathic\r\n             pseudo-obstruction, hypomotility syndrome)\r\n\r\n          -  Ascites\r\n\r\n          -  Gastrointestinal disorder (active ulcer, outlet obstruction, retention, gastroparesis,\r\n             ileus)\r\n\r\n          -  Upper gastrointestinal surgery (gastric resection, gastric banding, gastric by-pass)\r\n\r\n          -  Uncontrolled angina and/or Myocardial Infarction (MI) within last 3 months, Congestive\r\n             Heart Failure (CHF), or uncontrolled hypertension\r\n\r\n          -  Renal insufficiency (serum creatinine and potassium must be within normal limits)\r\n\r\n          -  Participation in an investigational study within 30 days prior to receiving study\r\n             medication (or within 60 days for investigational drugs with an elimination half-life\r\n             greater than 15 days)\r\n\r\n          -  Any clinically significant laboratory value at the screening, including pre-existing\r\n             electrolyte abnormality, based on clinical history that the Investigator feels may\r\n             affect the study evaluation\r\n\r\n          -  Hypersensitivity to active ingredients\r\n      ","sponsor":"Ferring Pharmaceuticals","sponsor_type":"Industry","conditions":"Bowel Preparation","interventions":[{"intervention_type":"Drug","name":"Drug: PicoPrep","description":"PICOPREP (sodium picosulfate, magnesium oxide and citric acid) powder for oral solution consisted of 2 pouches of powder administered in a divided dose. Each PICOPREP pouch was reconstituted by mixing the contents in a cup with 5 ounces of cold water. The first pouch was taken between 5:00 PM and 9:00 PM the evening prior to the colonoscopy procedure. Subjects were to consume five (5) 8-ounce glasses of clear liquids over the next few hours. The second pouch was taken approximately 5 hours before but no more than 9 hours prior to the colonoscopy procedure. Subjects were to consume three (3) 8-ounce glasses of clear liquids."},{"intervention_type":"Drug","name":"Drug: HalfLytely","description":"HalfLytely contains polyethylene glycol electrolyte solution (PEG-EL), sodium chloride, sodium bicarbonate and potassium chloride. The day prior to the colonoscopy procedure and after the first bowel movement or after 6 hours following administration of the bisacodyl tablets, whichever occurred first, subjects were to drink the 2 liter HalfLytely at a rate of one 8-ounce glass every 10 minutes. The entire solution was to be consumed."},{"intervention_type":"Drug","name":"Drug: bisacodyl","description":"Two 5 mg bisacodyl tablets were taken in the afternoon on the day prior to the colonoscopy procedure."}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist","time_frame":"Day 2","description":"Overall colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Aronchick scale. The Aronchick scale is a 4-step rating scale: inadequate, fair, good, and excellent. Excellent is defined as >90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization. Good is defined as >90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization."},{"outcome_type":"secondary","measure":"Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist","time_frame":"Day 2","description":"Overall colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Ottawa scale, a 5-step rating scale: inadequate, poor, fair, good, and excellent. Excellent is defined as mucosal detail clearly visible; if fluid is present, it is clear and there is almost no stool residue. Good - some turbid fluid or stool residue but mucosal detail still visible; washing and suctioning is not necessary. Fair - turbid fluid or stool residue obscuring mucosal detail. However, mucosal detail becomes visible with suctioning and washing is not necessary."},{"outcome_type":"secondary","measure":"Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug?","time_frame":"Day 2","description":"Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: very easy, easy, tolerable, difficult, very difficult"},{"outcome_type":"secondary","measure":"Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed?","time_frame":"Day 2","description":"Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no"},{"outcome_type":"secondary","measure":"Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation","time_frame":"Day 2","description":"Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Fair, Poor, Bad"},{"outcome_type":"secondary","measure":"Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was","time_frame":"Day 2","description":"Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Tolerable, Poor, Bad"},{"outcome_type":"secondary","measure":"Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Ask Your Doctor for This Preparation Again if You Need Another Colonoscopy in the Future?","time_frame":"Day 2","description":"Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no"},{"outcome_type":"secondary","measure":"Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Refuse the Same Preparation Again if it Were to be Prescribed to You in the Future?","time_frame":"Day 2","description":"Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no"},{"outcome_type":"secondary","measure":"Participants With Treatment-Emergent Adverse Events (TEAEs)","time_frame":"up to one month","description":"Counts of participants who had TEAEs are summarized in a variety of categories. Severity and relatedness to study drug are in the opinion of the investigator. Severity is rated on a 3-point scale: mild (awareness of signs or symptoms, but no disruption of usual activity), moderate (event sufficient to affect usual activity), and severe (inability to work or perform usual activities). Only severe TEAEs are summarized. Relatedness is assessed on a 4-point scale: unrelated, unlikely, possibly and probably. Both possibly and probably answers are reported as 'related' to study medication."}]}
{"nct_id":"NCT01153724","start_date":"2010-05-31","phase":"Phase 1","enrollment":35,"brief_title":"Relative Bioavailability of Olodaterol and Fluconazole","official_title":"Relative Bioavailability of 10 mcg Olodaterol (Solution for Inhalation Administered With the Respimat) at Steady State Alone or in Combination With Multiple Doses of 400 mg q.d. Fluconazole (Hard Capsule) in Healthy Male and Female Volunteers (an Open Label, Fixed Sequence, Phase I Study)","primary_completion_date":"2010-07-31","study_type":"Interventional","rec_status":"Completed","last_update":"2014-06-10","description":"This clinical trial is intended to investigate a possible effect of the CYP 2C9 inhibitor fluconazole on the bioavailability of olodaterol","other_id":"1222.48","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":21,"maximum_age":50,"population":"","criteria":"\n        Inclusion criteria:\r\n\r\n        Healthy male and female volunteers\r\n      ","sponsor":"Boehringer Ingelheim","sponsor_type":"Industry","conditions":"Healthy|Pulmonary Disease, Chronic Obstructive","interventions":[{"intervention_type":"Drug","name":"Drug: BI 1744","description":"10 mcg solution for oral inhalation"},{"intervention_type":"Drug","name":"Drug: Fluconazole","description":"400 mg capsule"}],"outcomes":[{"outcome_type":"primary","measure":"Area Under Curve From 0 to 6 Hours at Steady State (AUC0-6,ss)","time_frame":"Day 8 of period 1 and day 14 of period 2","description":"AUC0-6,ss represents the area under the concentration curve of olodaterol in plasma from 0 to time t=6 hours at steady state, where t is defined as the latest time-point where at least 2/3 of the subjects in both treatment periods reveal quantifiable plasma concentrations of olodaterol. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV."},{"outcome_type":"primary","measure":"Maximum Concentration at Steady State (Cmax,ss)","time_frame":"Day 8 of period 1 and day 14 of period 2","description":"Cmax,ss represents the maximum concentration of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma at steady state. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV."},{"outcome_type":"secondary","measure":"Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss)","time_frame":"Day 8 of period 1 and day 14 of period 2","description":"tmax,ss represents the time from dosing to maximum concentration of olodaterol and olodaterol glucuronide in plasma at steady state."},{"outcome_type":"secondary","measure":"Fraction of Urine Excretion From 0 to 24 Hours at Steady State (fe0-24,ss)","time_frame":"Day 8 of period 1 and day 14 of period 2","description":"fe0-24,ss represents the fraction of olodaterol eliminated in urine from time point 0 to 24 hours after administration at steady state."},{"outcome_type":"secondary","measure":"Amount of the Analyte Excreted in Urine From 0 to 24 Hours at Steady State (Ae0-24,ss)","time_frame":"Day 8 of period 1 and day 14 of period 2","description":"Ae0-24,ss represents the amount of olodaterol and olodaterol glucuronide excreted in urine from 0 to time t=24 at steady state. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV."},{"outcome_type":"secondary","measure":"Area Under Curve From 0 to 12 Hours at Steady State (AUC0-12,ss)","time_frame":"Day 8 of period 1 and day 14 of period 2","description":"AUC0-12,ss represents the area under the concentration curve of olodaterol glucuronide in plasma from 0 to time t=12 at steady state, where t is defined as the latest timepoint where at least 2/3 of the subjects in both treatment periods reveal quantifiable plasma concentrations of the analyte. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV."},{"outcome_type":"secondary","measure":"Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG","time_frame":"First administration of trial medication until 6 days after last administration of trial medication","description":"Clinical relevant abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events."},{"outcome_type":"secondary","measure":"Assessment of Tolerability by the Investigator","time_frame":"End of period 1 and end of period 2","description":"The investigator assessed tolerability based on adverse events and the laboratory evaluation at the end-of-trial examination. The investigator classified the overall tolerability according to the categories 'good', 'satisfactory', 'not satisfactory', and 'bad'."}]}
{"nct_id":"NCT01405729","start_date":"2010-05-31","enrollment":13,"brief_title":"Medial Patellofemoral Ligament Reconstruction: A Review of Technique, Accuracy, and Outcome","official_title":"Medial Patellofemoral Ligament Reconstruction: A Review of Technique, Accuracy, and Outcome","primary_completion_date":"2013-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2013-12-31","last_update":"2014-02-14","description":"The purpose of this retrospective study was to determine the accuracy of femoral tunnel placement utilizing Redfern et al's radiographic method for anatomic femoral attachment during MPFL reconstruction in addition to the resultant outcome.","other_id":"39977","observational_model":"Cohort","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":80,"population":"A single surgeon experience beginning in 2005 with patient's undergoing MPFL reconstruction\r\n        using intra-operative fluoroscopy for proper placement of the femoral tunnel.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients having undergone the MPFL procedure, starting January 1, 2005 through\r\n             February 3, 2010\r\n\r\n          -  Minimum follow up of 24 months\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnant women\r\n\r\n          -  Under 18 years of age\r\n\r\n          -  Previously undergone prior MPFL surgery\r\n\r\n          -  Participated in any previous research studies involving the use of ionizing radiation\r\n             (either radioisotopes or diagnostic x-rays during the past 12 months.\r\n\r\n          -  The participant should not volunteer for other research studies involving the use of\r\n             ionizing radiation within 12 months of completing the current study.\r\n      ","sponsor":"University of Utah","sponsor_type":"Other","conditions":"Healthy|Medial Patellofemoral Ligament Reconstruction","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Radiograph measurements","time_frame":"5 years"}]}
{"nct_id":"NCT01165879","start_date":"2010-05-31","enrollment":100,"brief_title":"Measuring Uterine Electrical Activity Throughout Pregnancy and Labor Measuring Uterine Electrical Activity Throughout Pregnancy and Labor","primary_completion_date":"2012-05-31","study_type":"Observational","rec_status":"Unknown status","last_update":"2011-06-10","description":"The EUM100pro (Electrical Uterine Monitor)is a uterine contraction monitor which measures uterine contractions based on the electrical activity of the uterine muscle.The study will compare the EUM100pro measurements to the already existing uterine contractions monitors (tocodynamometer and Intra Uterine Pressure Catheter) in pregnant women with complaints of uterine contractions.","other_id":"HTA5347","observational_model":"Case-Control","time_perspective":"Retrospective","sampling_method":"Probability Sample","gender":"Female","minimum_age":18,"maximum_age":60,"population":"Pergnant women which are admitted to Meir Medical Center with complaints of uterine\r\n        contractions starting.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Women at term with complaint of uterine contractions at Meir Medical Center\r\n\r\n          -  Women at preterm with complaint of uterine contractions at Meir Medical Center.\r\n\r\n          -  Women at gestational age >24 weeks\r\n\r\n          -  Subjects who understood, agreed and signed the informed consent form\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subjects who refused to sign the informed consent form\r\n\r\n          -  Abnormal fetal heart rate recording at admittance\r\n\r\n          -  Subjects with indications for immediate delivery\r\n\r\n          -  Subjects younger than 18 years of age\r\n\r\n          -  Subjects at gestational age <24 weeks\r\n      ","sponsor":"OB-Tools Ltd.","sponsor_type":"Industry","conditions":"Pregnancy","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"The study primary outcome is to demonstrate that the EUM100pro uterine contractions measurements is as good as the current methods for monitoring pregnancy in labor (tocodynamometer, IUPC).","time_frame":"two years","description":"The primary outcome will be measured by correlation of timing of :peak display in beginning, during and end of peak in the EUM100pro versus the timing of the peak display in beginning, during and the end tocodynamometer and or IUPC peak."},{"outcome_type":"primary","measure":"To evaluate patient safety","time_frame":"one year","description":"Measurements of device related adverse events throughout the study."},{"outcome_type":"secondary","measure":"Correlation of uterine contractions intensity between EUM100pro and Intra Uterine Pressure Catheter measurements.","time_frame":"one year","description":"The secondary outcome will investigate a correlation between the intensity/peak of contraction of mechanical contraction as measured by Intra Uterine pressure catheter and the intensity/peak of contraction of electrical activity as measured by the EUM exists."},{"outcome_type":"secondary","measure":"To evaluate usability of the EUM100pro","time_frame":"one year"},{"outcome_type":"secondary","measure":"to evaluate whether a fetal ECG can be exctraced from the electrical signal of the uterus.","time_frame":"one year","description":"The electrical signal recorded from the abdomen thechnically contain the uterine muscle electrical activity but also the electrical signal from the fetal ecg."}]}
{"nct_id":"NCT01162239","start_date":"2010-05-31","phase":"Phase 3","enrollment":216,"brief_title":"Maintaining Nonsmoking","official_title":"Maintaining Nonsmoking","primary_completion_date":"2016-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-06-30","last_update":"2020-11-12","description":"The research is based on a chronic disorder model of cigarette smoking which suggests that long-term treatment targeted to prevent relapse may be useful. Based on this model, the investigators have developed a relapse prevention treatment to intervene on five areas important in relapse prevention, including fluctuating motivation, depression, withdrawal, weight gain, and social support. This treatment protocol has produced high long-term abstinence rates when implemented in a clinical research setting. The current study will evaluate the treatment model when implemented in a medical outpatient setting.","other_id":"DA002538","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  At least 18 years of age\r\n\r\n          -  Must be smoking 5 or more cigarettes per day\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Previous history of bipolar/manic-depressive disorder\r\n\r\n          -  Current diagnosis of schizophrenia\r\n\r\n          -  Acute life threatening diseases\r\n\r\n          -  Evidence of alcohol or other drug abuse so severe that the patient is judged to be\r\n             potentially unable to comply with the protocol\r\n\r\n          -  Pregnancy or lactation\r\n\r\n          -  Individuals with out of normal range blood pressure, active angina, valve disease,\r\n             valve replacement, active cardiomyopathies, myocardial infarction or Coronary artery\r\n             bypass grafting (CABG) within one year, and Congestive heart failure (CHF)\r\n      ","sponsor":"University of California, San Francisco","sponsor_type":"Other","conditions":"Nicotine Dependence","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Check-ins with medical staff","description":"Monthly brief (10-15 minutes) meetings with medical staff."},{"intervention_type":"Drug","name":"Drug: Varenicline","description":"All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid. Participants in the Extended Relapse Prevention plus varenicline will receive varenicline for up to 40 additional weeks."},{"intervention_type":"Behavioral","name":"Behavioral: Initial Individual counseling","description":"Five 90 minute individual counseling sessions to occur during the first 12 weeks of initial treatment."},{"intervention_type":"Behavioral","name":"Behavioral: Extended Individual Counseling - Health Model","description":"Monthly counseling sessions across a nine month period with content based on a health education model. Each session is 30-45 minutes in duration."},{"intervention_type":"Behavioral","name":"Behavioral: Extended Individual Counseling - Relapse Prevention Model","description":"Eleven individual counseling sessions across a nine month period with content based on a relapse prevention model. Each session is 30-45 minutes in duration."}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 12","time_frame":"12 weeks following treatment initiation","description":"Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 parts per million (ppm)) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent."},{"outcome_type":"primary","measure":"Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 24","time_frame":"24 weeks following treatment initiation","description":"Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent."},{"outcome_type":"primary","measure":"Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 52","time_frame":"52 weeks following treatment initiation","description":"Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent."},{"outcome_type":"primary","measure":"Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 64","time_frame":"64 weeks following treatment initiation","description":"Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent."},{"outcome_type":"primary","measure":"Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 104","time_frame":"104 weeks following treatment initiation","description":"Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent."},{"outcome_type":"secondary","measure":"Comparison of Combined Extended vs Brief Treatment at Week 24","time_frame":"24 weeks following treatment initiation","description":"The three extended treatment programs were combined and compared to the Brief treatment, with extended treatments expected to produce significant higher CO corrected abstinence rates overall. Comparisons will be tested using Chi-Square analysis."},{"outcome_type":"secondary","measure":"Comparison of Combined Extended vs Brief Treatment at Week 52","time_frame":"52 weeks following treatment initiation","description":"The three extended treatment programs were combined and compared to the Brief treatment, with extended treatments expected to produce significant higher CO corrected abstinence rates overall. Comparisons will be tested using Chi-Square analysis."}]}
{"nct_id":"NCT01548937","start_date":"2010-05-31","phase":"Phase 2","enrollment":39,"brief_title":"Serotonin Transporter Density in Late-life Depression With and Without Dementia","official_title":"Serotonin Transporter Density in Late-life Depression With and Without Dementia","primary_completion_date":"2012-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-12-31","last_update":"2016-01-28","description":"This study will recruit a total of 40 evaluable subjects (20 cognitively depressive, and 20 AD depressive); each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping. Safety measurement will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events. This study is expected to be completed in a period of 3 years.","other_id":"98-2132A","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patients may be enrolled in the AD depressive group if they:\r\n\r\n               -  Are males or females at least 50 years of age;\r\n\r\n               -  Fulfilled the DSM-IV criteria for Major depressive disorder (APA, 1994) by MINI\r\n                  interview.\r\n\r\n               -  Meet the NINCDS/ADRDA(National institute of Neurological and Communicative\r\n                  Disorders and Stroke/Alzheimer's Disease and Related Disorders Association)\r\n                  criteria for probable AD\r\n\r\n               -  A Mini Mental State Examination (MMSE) score at screening between 10 and 24\r\n                  inclusive;\r\n\r\n               -  Give informed consent. If the patient is incapable of giving informed consent,\r\n                  the caregiver may consent on behalf of the patient (the patient must still\r\n                  confirm assent).\r\n\r\n          2. Patients may be enrolled in the cognitively depressive group if they:\r\n\r\n               -  Are males or females at least 50 years of age;\r\n\r\n               -  Fulfilled the DSM-IV criteria for Major depressive disorder (APA, 1994) by MINI\r\n                  interview.\r\n\r\n               -  Memory function above the lower normal limits (i.e. 1.5 SD above the mean) on\r\n                  tests for episodic memory.\r\n\r\n               -  Clinical Dementia Rating = 0. Memory Box score must be 0.\r\n\r\n               -  Cognitively normal, based on an absence of significant impairment in cognitive\r\n                  functions or ADL.\r\n\r\n               -  A MMSE score at screening > 24 for those with education level of 6 years or above\r\n                  and > 17 for those are illiterate;\r\n\r\n               -  Give informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnant or becoming pregnant during the study (as documented by pregnancy testing at\r\n             screening or at any date during the study according to the PI discretion) or current\r\n             breast feeding.\r\n\r\n          -  Conditions affecting brain structure or function (e.g., stroke, diabetes, head trauma,\r\n             depression) or use of cognitively\r\n\r\n          -  Substance abuse.\r\n\r\n          -  Alcohol dependence\r\n      ","sponsor":"Chang Gung Memorial Hospital","sponsor_type":"Other","conditions":"Melancholia","interventions":[{"intervention_type":"Drug","name":"Drug: I-123 ADAM","description":"This study will recruit a total of 40 evaluable subjects (20 cognitively depressive, and 20 AD depressive), Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping.\r\nSafety measurement will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events."}],"outcomes":[{"outcome_type":"primary","measure":"Evaluate the differences of serotonin transporter activity among depressive patient with or without dementia.","time_frame":"three years","description":"To expand the database of I-123 ADAM SPECT imaging in AD depressive and cognitively depressive patients to refine the definition of a positive scan in patient with AD and MDD."},{"outcome_type":"secondary","measure":"Evaluate the relationship between the serotonin transporter activity and F-18 FDG PET image patter.","time_frame":"three years","description":"To expand the safety database of I-123 ADAM SPECT imaging Safety variables include adverse event count, lab parameters, vital signs, and ECG. Comparison will be generally made to baseline, as appropriate."}]}
{"nct_id":"NCT01752010","start_date":"2010-05-31","phase":"N/A","enrollment":98,"brief_title":"Comparing Acupuncture, BioModulator, and Transcutaneous Electrical Nerve Stimulation for Symptomatic Treatment of Chronic Pain.","official_title":"A Randomized Study Comparing the Tennant BioModulator to Transcutaneous Electrical Nerve Stimulation (TENS) and Traditional Chinese Acupuncture for the Symptomatic Treatment of Chronic Pain Among Injured Service Members.","primary_completion_date":"2014-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-04-30","last_update":"2015-05-19","description":"The primary objective of this preliminary study is to compare the Tennant BioModulator with Transcutaneous Electrical Nerve Stimulation (TENS) and Traditional Chinese Acupuncture for the management of chronic pain among injured service members. The secondary objective is to investigate any associative effects or benefits on sleep, Post-Traumatic Stress Disorder (PTSD) symptoms, or depression.","other_id":"C.2009.098","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subjects must be Injured service members between the ages of 18 and 60, inclusive;\r\n\r\n          -  The pain must have been present for 3 months or greater prior to entry into the study;\r\n\r\n          -  Subjects must agree to follow the medication regime as directed by the pain clinic\r\n             provider for the duration of the study;\r\n\r\n          -  Subjects must be able to speak and read English and understand study procedures\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Epilepsy\r\n\r\n          -  Pregnancy, or considering pregnancy within the study time-frame\r\n\r\n          -  Pacemaker\r\n\r\n          -  History of cardiac arrhythmias\r\n\r\n          -  Implantable devices (AICD, pump, etc.)\r\n\r\n          -  Surgical intervention during the past month for the treatment of low back pain or its\r\n             underlying etiology\r\n\r\n          -  Documented history of prescription medication abuse\r\n\r\n          -  Abuse of illicit drugs within the last 6 months\r\n\r\n          -  Participation in a clinical trial for an investigational drug and/or agent within 30\r\n             days prior to screening\r\n      ","sponsor":"Samueli Institute for Information Biology","sponsor_type":"Other","conditions":"Chronic Pain|Depression|PTSD Symptoms|Sleep","interventions":[{"intervention_type":"Other","name":"Other: Traditional Chinese Acupuncture","description":"Treatment will be performed by an experienced provider, and may include insertion of sterile 32-gage (0.25mm) acupuncture needles on any part of the body that can be needled while the subject is lying prone with their head in a face cradle. The needles are usually retained for 20-30 minutes along various meridian points identified by the practitioner as being \"blocked.\" Needles will be inserted to the depth typically recommended for the particular point of concern; generally 1 to 3cm. There are no constraints on the number of needles used. Acupuncture points are points of lower resistance and higher electrical conductance than the surrounding tissue. Placing the acupuncture needles into points identified as blocked is believed to help restore the flow of energy and stimulates the release of endorphins. The subject's level of pain is assessed on a 0-10 pain scale. Thirty minute acupuncture treatments will be given by the provider once a week for 6 weeks at the pain clinic."},{"intervention_type":"Device","name":"Device: Tennant Biomodulator Treatment","description":"An FDA-approved Tennant 650 BioModulator will be used to deliver electrical stimulation. The device will be applied directly on top of the subject's area of pain for one minute; power is adjusted until the subject feels a slight tingle. Random variations of pulse amplitude are set from zero to a chosen comfort limit. A feedback mechanism is provided by the constant monitoring of skin impedance. The device is then pressed onto the site of pain and rotated counter-clockwise. After a minute, the device is placed on the opposite side of the pain site and the procedure repeated. The subject's level of pain is assessed on a 0-10 pain scale. At no time is the level of electrical stimulation allowed to cause sustained pain. The subject will receive a weekly 15 minute visit that includes a treatment provided by the pain provider. The provider will teach the subject how to use the machine by themselves and instruct the subject to use the machine twice a day on their own during the study."},{"intervention_type":"Device","name":"Device: Transcutaneous electrical nerve stimulation (TENS) Treatment","description":"An FDA-approved Empi TENS unit will be used to deliver the transcutaneous electrical nerve stimulation. The low frequency TENS unit will be applied to the subject's area of pain by the use of four integrated self-adhering 5x5 cm electrodes. The electrodes will be positioned at a distance of 3 cm and centered over the area that is most painful. The device rapidly delivers therapeutic electrical currents at various frequencies off and on 150 times a second. The subject's level of pain is assessed on a 0-10 pain scale. At no time is the level of electrical stimulation allowed to cause sustained pain. The subject will receive a weekly 15 minute visit that includes a treatment provided by the pain provider. The provider will teach the subject how to use the machine by themselves and instruct the subject to use the machine twice a day on their own during the study."}],"outcomes":[{"outcome_type":"primary","measure":"Chronic pain","time_frame":"Baseline; post-intervention; one-month follow up."},{"outcome_type":"secondary","measure":"Depression, PTSD symptoms, Sleep.","time_frame":"Baseline; post-intervention; one-month follow up."}]}
{"nct_id":"NCT01195714","start_date":"2010-05-31","phase":"Phase 2","enrollment":120,"brief_title":"Study of Mini-Chop Plus Ofatumumab To Treat Cd 20+ Diffuse Large B-Cell Lymphoma In Patients Aged Over 80 Years","official_title":"PHASE II STUDY OF MINI-CHOP PLUS OFATUMUMAB (O) IN NON PREVIOUSLY TREATED PATIENTS AGED OVER 80 YEARS WITH CD 20+ DIFFUSE LARGE B-CELL LYMPHOMA","primary_completion_date":"2014-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-04-30","last_update":"2018-03-07","description":"This study is a multicentric, phase II, open-label, non-randomized trial evaluating the efficacy of O-miniCHOP in patients aged over 80 years with non previously treated CD20+ diffuse large B-cell lymphoma (age-adjusted IPI=0 to3), stage I, II, III or IV with a performance status ECOG from 0 to 4. The anticipated study dates (start / end) are: 2010 - 2013. The study will evaluate a cohort of 120 patients (approximately 95 in France, 15 in Belgium, 5 in Switzerland and 5 in Portugal). Patients will be recruited over 30 months and followed at least one year after the last patient has been included. The duration of the treatment period is approximately 20 weeks.","other_id":"LNH09-7B","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":81,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Patient with histologically proven CD20+ diffuse large B-cell lymphoma (DLBCL) (WHO\r\n        classification 2008) including clinical subtypes (primitive mediastinal, intravascular,\r\n        etc.) May also be included : de Novo Transformed DLBCL from low grade lymphoma (Follicular,\r\n        other...) and DLBCL associated with some small cell infiltration in bone marrow\r\n\r\n          -  Or CD20+ B-cell lymphoma, with intermediate features between DLBCL and Burkitt or with\r\n             intermediate features between DLBCL and classical Hodgkin lymphoma\r\n\r\n          -  Or CD20+ Follicular lymphoma grade 3B\r\n\r\n          -  Or CD20+ Aggressive B-cell lymphoma unclassifiable Aged over 80 years. Ann Arbor stage\r\n             I, II, III or IV. All aaIPI Patient non previously treated. All ECOG performance\r\n             status With a minimum life expectancy of 3 months. Negative HIV, HBV and HCV\r\n             serologies test < 4 weeks (except after vaccination). Patient able to give his consent\r\n             and having previously signed a written informed consent.\r\n\r\n        Patient affiliated to social security system, if applicable\r\n\r\n        Exclusion Criteria:\r\n\r\n        Any other histological type of lymphoma, Burkitt included. Any history of treated or\r\n        non-treated small-B cell lymphoma. Central nervous system or meningeal involvement by\r\n        lymphoma. Contra-indication to any drug contained in the chemotherapy regimens. Any serious\r\n        active disease (according to the investigator's decision). Poor renal function (creatinin\r\n        level>150mol/l), poor hepatic function (total bilirubin level>30mmol/l, transaminases>2.5\r\n        maximum normal level) unless these abnormalities are related to the lymphoma.\r\n\r\n        Poor bone marrow reserve as defined by neutrophils <1.5 G/l or platelets <100 G/l, unless\r\n        related to bone marrow infiltration.\r\n\r\n        Any history of cancer during the last 5 years with the exception of non-melanoma skin\r\n        tumors or stage 0 (in situ) cervical carcinoma. Patients previously diagnosed with prostate\r\n        cancer are eligible if (1) their disease was T1-T2a, N0, M0, with a Gleason score <7, and a\r\n        prostate specific antigen (PSA) <10 ng/mL prior to initial therapy, (2) they had definitive\r\n        curative therapy (ie, prostatectomy or radiotherapy) >2 years before Day 1 of Cycle 1, and\r\n        (3) at a minimum 2 years following therapy they had no clinical evidence of prostate\r\n        cancer, and their PSA was undetectable if they underwent prostatectomy or <1 ng/mL if they\r\n        did not undergo prostatectomy.\r\n\r\n        Treatment with any investigational drug within 30 days before planned first cycle of\r\n        chemotherapy and during the study.\r\n\r\n        Prior treatment with anti-CD20 monoclonal antibody or alemtuzumab within 3 months prior to\r\n        start of therapy Adult patient under tutelage.\r\n      ","sponsor":"The Lymphoma Academic Research Organisation","sponsor_type":"Other","conditions":"Non Previously Treated CD20+ Diffuse Large B-cell Lymphoma","interventions":[{"intervention_type":"Drug","name":"Drug: Ofatumumab","description":"solution for perfusion, 1000mg per cycle, 1 cycle every 3 weeks, total 6 cycles"}],"outcomes":[{"outcome_type":"primary","measure":"Overall Survival","time_frame":"2 years"}]}
{"nct_id":"NCT01084434","start_date":"2010-05-31","phase":"N/A","enrollment":100,"brief_title":"Probiotic, Prebiotic and Synbiotic Effect on Immunity","official_title":"Double-blind, Placebo Controlled Randomized Parallel Study to Determine the Effects of Pre-pro and Synbiotic Administration on the Immune Response to Influenza Vaccination and Faecal Microbiota in Healthy Adults","primary_completion_date":"2011-01-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2011-06-30","last_update":"2010-03-10","description":"The aim of the study is to investigate the effect of dietary supplements such as probiotic, prebiotic and synbiotic on the immune response to influenza vaccination and faecal microbiota in adult healthy volunteers.","other_id":"F3168407","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":45,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Signed consent form\r\n\r\n          -  Age 40-65 years\r\n\r\n          -  Body mass index 18.5-30 inclusive\r\n\r\n          -  Good general health as determined by medical questionnaires\r\n\r\n          -  Not vaccinated with the current seasonal influenza (2009) or swine flu vaccine\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Evidence of physical or mental disease or planned major surgery, which might limit\r\n             participation in or completion of the study\r\n\r\n          -  History of drug misuse, including alcohol\r\n\r\n          -  Allergy to the vaccine\r\n\r\n          -  Asplenia and other acquired or congenital immunodeficiency\r\n\r\n          -  Severe allergy such as asthma, hay-fever, dermatitis or being treated on these\r\n\r\n          -  History of severe abnormal drug reaction\r\n\r\n          -  Any autoimmune disease\r\n\r\n          -  Diabetic (type 1 or type2)\r\n\r\n          -  Food allergy manifested by gastrointestinal, skin, respiratory , neurological,\r\n             anaphylaxis symptoms\r\n\r\n          -  Lactose intolerance showed by clinical symptoms such as nausea, cramping, bloating,\r\n             diarrhea and flatulence after consuming lactose containing dairy products (milk,\r\n             yoghurt, butter, cheese, ice-cream, sour cream) or lactose non-dairy products ( whey,\r\n             milk solids, modified milk ingredients)\r\n\r\n          -  Participation in experimental drug trial within four weeks prior to study\r\n\r\n          -  Participation in prebiotics or laxative trial within the previous three months\r\n\r\n          -  Use of antibiotics within the previous six months\r\n\r\n          -  Chronic constipation, diarrhoea or other chronic gastro-intestinal complaint\r\n\r\n          -  Intake of other prebiotics or probiotics, drugs active on gastrointestinal motility,\r\n             or a laxative of any class for four weeks prior to study\r\n\r\n          -  Use of prescribed medication\r\n\r\n          -  Regular use of aspirin or other anti-inflammatory drugs\r\n      ","sponsor":"University of Reading","sponsor_type":"Other","conditions":"Dietary Intervention","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: probiotic","description":"Bifidobacterium lactis HN019 10^9 CFU/day 1 sachet once a day for 7 weeks"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: prebiotic","description":"Galactooligosaccharide 5.5 g/day 1 sachet once a day for 7 weeks"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Synbiotic","description":"(Bifidobacterium lactis 10^9 CFU + Galactooligosaccharide 5.5g) / day - 1 sachet once a day for 7 weeks"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Placebo","description":"Maltodextrin 5.5g/day - 1 sachet once a day for 7 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"The primary outcome would be a higher change in antibody levels in response to influenza vaccination compared to placebo group.","time_frame":"2 and 4 weeks after vaccination"},{"outcome_type":"secondary","measure":"The secondary outcome would be a change in faecal microbiota groups and a change in their metabolic activities.","time_frame":"at 0, 7 and 10 weeks on pro-, pre,synbiotic treatment"}]}
{"nct_id":"NCT01326390","start_date":"2010-05-31","enrollment":13,"brief_title":"Impact of C-arm CT in Decreased Renal Function Undergoing TACE for Tx of Hepato-Cellular Carcinoma","official_title":"Impact of C-arm CT in Patients With Decreased Renal Function Undergoing Transhepatic Arterial Chemoembolization (TACE) for the Treatment of Hepato-Cellular Carcinoma","primary_completion_date":"2012-01-31","study_type":"Observational","rec_status":"Terminated","completion_date":"2012-01-31","last_update":"2016-07-01","description":"Impact on contrast dose or total volume of contrast required to effectively treat the targeted tumor.","other_id":"HEP0035","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"All patients we are seeking will already have been scheduled to undergo liver Transhepatic\r\n        arterial chemoembolizationWorld Health Organization treatment using C-arm CT as the imaging\r\n        guidance (with limited Digital Subtraction angiography as needed).","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patients must be affected by HCC\r\n\r\n          2. Patients must have diminished renal function (GFR<60 ml/min/1.73m^2)\r\n\r\n          3. Patients must be 18 years old or older\r\n\r\n          4. Patients must have received an abdominal CT, PET/CT scan or MRI, completed prior to\r\n             the TACE procedure.\r\n\r\n          5. Ability to understand and the willingness to sign a written informed consent document.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Subjects under the age of 18\r\n\r\n          2. Patients currently on dialysis\r\n\r\n          3. Pregnant women\r\n      ","sponsor":"Stanford University","sponsor_type":"Other","conditions":"Kidney (Renal Cell) Cancer","interventions":[{"intervention_type":"Device","name":"Device: dTA/dBA C-arm fluoroscopy system with Dyna CT","description":"C-arm CT of the liver; state-of-the-art flat panel detector on a ceiling or floor mounted C-arm gantry"},{"intervention_type":"Procedure","name":"Procedure: DSA arteriogram- hepatic arteries","description":"Standard of care"},{"intervention_type":"Procedure","name":"Procedure: CO2 aortogram","description":"Standard of care"}],"outcomes":[{"outcome_type":"primary","measure":"Proportion of patients that develop renal failure (defined as a decline of renal function, as measured by glomerular filtration rate, of 25% or more from pre-procedural)","time_frame":"3 weeks"}]}
{"nct_id":"NCT00922207","start_date":"2010-05-07","phase":"Phase 4","enrollment":280,"brief_title":"A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Adefovir or Entecavir in Patients With HBeAg-Positive Chronic Hepatitis B","official_title":"A Randomized, Open-label Study of the Effect of Peginterferon Alfa-2a (40KD)(PEGASYS) in Combination With Adefovir or Entecavir on HBeAg Seroconversion in Patients With HBeAg Positive Chronic Hepatitis B","primary_completion_date":"2014-09-29","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-09-29","last_update":"2017-04-10","description":"This 3 arm study will assess the efficacy and safety of PEGASYS alone, or in combination with Adefovir or Entecavir in patients with HBeAg positive chronic hepatitis B. Patients will be randomized to receive 1)PEGASYS 180 micrograms sc weekly for 48 weeks + placebo from weeks -4 to 2;2)PEGASYS 180 micrograms sc weekly for 48 weeks + Adefovir from weeks -4 to 2; or 3)PEGASYS 180 micrograms sc weekly for 48 weeks + Entecavir from weeks -4 to 2. Treatment will be followed by 24 weeks of treatment-free follow-up.The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.","other_id":"ML21827","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  adult patients, 18-65 years of age;\r\n\r\n          -  HBeAg+ve for >=3 months;\r\n\r\n          -  positive serum HBV DNA within 3 months prior to entry;\r\n\r\n          -  patients with chronic hepatitis B, either naive to HBV treatment, or not\r\n             responded/relapsed to nucleoside analogues;\r\n\r\n          -  >=3 months treatment-free interval from nucleotide analogues.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  evidence of decompensated liver disease;\r\n\r\n          -  history or other evidence of a medical condition associated with chronic liver disease\r\n             othr than viral hepatitis;\r\n\r\n          -  co-infection with active hepatitis A,C or D, or HIV.\r\n      ","sponsor":"Hoffmann-La Roche","sponsor_type":"Industry","conditions":"Hepatitis B, Chronic","interventions":[{"intervention_type":"Drug","name":"Drug: Adefovir","description":"From week -4 to week 2"},{"intervention_type":"Drug","name":"Drug: Entecavir","description":"From week -4 to week 2"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"From week -4 to week 2"},{"intervention_type":"Drug","name":"Drug: peginterferon alfa-2a [Pegasys]","description":"180 micrograms sc weekly, from week 1-48"}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of Participants With Hepatitis B e-Antigen (HBeAg) Seroconversion at 100 Weeks After Start of Treatment","time_frame":"Week 100","description":"HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of hepatitis B e-antibody (anti-HBe/HBeAb) (a positive result for anti-HBe)."},{"outcome_type":"secondary","measure":"Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100","time_frame":"Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100","description":"HBV DNA (copies per milliliter [copies/mL]) represented the viral load for Hepatitis B Virus (HBV), and was considered an indicator of viral replication."},{"outcome_type":"secondary","measure":"Percentage of Participants Who Were HBeAg Negative","time_frame":"Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100"},{"outcome_type":"secondary","measure":"Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive","time_frame":"Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100"},{"outcome_type":"secondary","measure":"Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels","time_frame":"Baseline, Weeks 6, 12, 16, 22, 28, 34, 40, 46, 52, 64, 76, 88, and 100","description":"The normal range for ALT is 10 to 40 international units per liter (IU/L)."},{"outcome_type":"secondary","measure":"Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100","time_frame":"Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100"},{"outcome_type":"secondary","measure":"Percentage of Participants With Combined Response","time_frame":"Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100","description":"Combined response was defined as having negative HBeAg, HBV DNA less than (<) 100,000 copies/mL, and normal ALT level (10-40 IU/L)."}]}
{"nct_id":"NCT01099774","start_date":"2010-05-01","phase":"Phase 3","enrollment":597,"brief_title":"Safety and Efficacy of Different Formulations of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension","primary_completion_date":"2011-04-29","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-04-29","last_update":"2019-04-17","description":"This study will evaluate the safety and efficacy of bimatoprost 0.03% formulation B ophthalmic solution with LUMIGAN (bimatoprost ophthalmic solution 0.03%) once daily for 12 weeks in patients with glaucoma or ocular hypertension","other_id":"192024-048","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patient has ocular hypertension or glaucoma in both eyes\r\n\r\n          -  Requires IOP-lowering therapy in each eye\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Active or recurrent eye disease that would interfere with interpretation of study data\r\n             in either eye\r\n\r\n          -  History of any eye surgery or laser in either eye within 6 months\r\n\r\n          -  Required chronic use of other eye medications during the study\r\n\r\n          -  Anticipated wearing of contact lenses during the study.\r\n\r\n          -  Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days\r\n      ","sponsor":"Allergan","sponsor_type":"Industry","conditions":"Glaucoma|Ocular Hypertension","interventions":[{"intervention_type":"Drug","name":"Drug: Bimatoprost 0.03% Formulation B Ophthalmic Solution","description":"One drop administered in each eye, every evening, for 12 weeks"},{"intervention_type":"Drug","name":"Drug: Bimatoprost 0.03% Ophthalmic Solution","description":"One drop administered in each eye, every evening, for 12 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12","time_frame":"Baseline, Week 12","description":"Change from baseline in worse eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements in the worse eye were evaluated at hours 0, 2, and 8. A negative number change from baseline indicated a reduction in IOP, and a positive number change from baseline indicated an increase in IOP."},{"outcome_type":"primary","measure":"Average Eye IOP at Week 12","time_frame":"Baseline, Week 12","description":"Average Eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. Baseline data are included for reference only."},{"outcome_type":"primary","measure":"Average Eye IOP at Week 6","time_frame":"Week 6","description":"Average Eye IOP at Week 6 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported."},{"outcome_type":"primary","measure":"Average Eye IOP at Week 2","time_frame":"Week 2","description":"Average Eye IOP at Week 2 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported."}]}
{"nct_id":"NCT01498146","start_date":"2010-04-30","enrollment":85,"brief_title":"Finding Atrial Fibrillation in Patients With Unexplained Stroke Using Longterm Cardiac Monitoring","official_title":"Stroke Prior to Diagnosis of Atrial Fibrillation Using Longterm Observation With Implantable Cardiac Monitoring Apparatus Reveal(SURPRISE) -the SURPRISE Study","primary_completion_date":"2013-10-31","study_type":"Observational","rec_status":"Completed","completion_date":"2013-10-31","last_update":"2021-01-28","description":"The SURPRISE study investigates atrial fibrillation(AFIB) in patients with a previous unexplained stroke. It uses long term monitoring of the heart of up to three years, searching for paroxysmal atrial fibrillation(PAF) otherwise undetected in this population.","other_id":"H-4-2010-014","observational_model":"Other","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":1.5,"population":"the patients are included from the investigators stroke unit and day clinic","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Computerized Tomography (CT) or Magnetic resonance imaging (MRI) verified cryptogenic\r\n             stroke or TIA;\r\n\r\n          -  > 18 years of age,\r\n\r\n          -  the ability to provide a written consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  prior or known AFIB\r\n\r\n          -  AF found during work up including 24 hour telemetric monitoring.\r\n      ","sponsor":"Bispebjerg Hospital","sponsor_type":"Other","conditions":"Stroke","interventions":{},"outcomes":{}}
{"nct_id":"NCT01114035","start_date":"2010-04-30","phase":"N/A","enrollment":41,"brief_title":"Characterization Phenotypic and Genetic Study of the Intestinal Epithelial Dysplasia or Tufting Enteropathy (TE)","official_title":"Characterization Phenotypic and Genetic Study of the Intestinal Epithelial Dysplasia or TE","primary_completion_date":"2013-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-07-31","last_update":"2013-08-02","description":"This PHRC is centred on the intestinal epithelial dysplasia ( DEI) or \" tufting enteropathy \" or TE the clinical and histo-pathological descriptions of which are specified well to the digestive plan(shot).","other_id":"P 070163","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","maximum_age":15,"population":"","criteria":"\n        Inclusion criteria :\r\n\r\n        Patient sent in the service of Gastroenterology Pediatric Hepatology of the Hospital Necker\r\n        Enfants Malades for an intestinal transplantation, from 0 to 15 years old presenting:\r\n\r\n          -  A known epithelial dysplasia (Diagnosis established on the clinical and\r\n             histo-morphological criteria from one or several intestinal biopsies, with or without\r\n             diagnosis known or suspected in the family). The objectives are the phenotypic\r\n             characterization of the case and the revealing of markers characteristic\r\n             immuno-histochemistry which can be of use to the diagnosis and direct to candidate\r\n             genes\r\n\r\n          -  Or a suspicion of dysplasia epithelial (compatible clinical History(Story) with or\r\n             without extra-digestive demonstrations(appearances) of type keratinate punctuated\r\n             superficial (KPS), abnormalities cutanea or atresia CHOANS with atypical digestive\r\n             histology and without diagnosis known in the family). The objectives are the diagnosis\r\n             on the basis of the immuno-histochemistry expression and the existence of an\r\n             infringement(achievement) conjunctival and the phenotypic characterization of the case\r\n\r\n          -  The lit(enlightened) and written consent of both holders of the parental authority\r\n             must be beforehand obtained as well as that of the patient if it is in age to\r\n             understand(include).\r\n\r\n        Exclusion criteria :\r\n\r\n          -  Not membership in a national insurance scheme (beneficiary or legal successor)\r\n\r\n          -  Family not understanding(including) French\r\n\r\n          -  Refusal of one of both relatives(parents)\r\n      ","sponsor":"Assistance Publique - Hpitaux de Paris","sponsor_type":"Other","conditions":"Intestinal Epithelial Dysplasia|Tufting Enteropathy","interventions":[{"intervention_type":"Genetic","name":"Genetic: blood samples and skin biopsies","description":"to detect mutations"},{"intervention_type":"Genetic","name":"Genetic: Skin biopsies","description":"to detect mutations"}],"outcomes":[{"outcome_type":"primary","measure":"gene identification","time_frame":"6 months","description":"identification of different family of genes involved in intestinal dysplasia"},{"outcome_type":"secondary","measure":"mutation identification","time_frame":"6 months","description":"Identification of different mutations involved in intestinal dysplasia"}]}
{"nct_id":"NCT01135082","start_date":"2010-04-30","phase":"N/A","enrollment":90,"brief_title":"Pneumococcal Conjugate Vaccine (PCV) in HIV- Infected Children","official_title":"The Immunogenicity and Safety of Pneumococcal Conjugate Vaccine in Human Immunodeficiency Virus - Infected Children","primary_completion_date":"2010-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-06-30","last_update":"2014-09-04","description":"The purpose of this study is to evaluate the immunogenicity and safety of 7 - valent pneumococcal conjugated vaccine in HIV - infected children, and assess the predictive factors for protective antibody responses after receiving the vaccine.","other_id":"HIV-NAT 135","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":0.16667,"maximum_age":9,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. HIV - infected children\r\n\r\n               -  HIV infected individuals\r\n\r\n               -  Age between 2 months to 9 years\r\n\r\n               -  Signed written informed consent\r\n\r\n          2. HIV - exposed negative children\r\n\r\n               -  Maternal HIV infection, documented prior to delivery.\r\n\r\n               -  Age between 2 months to 9 years\r\n\r\n               -  Signed written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Active opportunistic infection\r\n\r\n          -  History of hypersensitivity to pneumococcal conjugate vaccine or diphtheria toxoid\r\n\r\n          -  Using oral steroid or immunosuppressive drugs\r\n\r\n          -  Received pneumococcal conjugate vaccine, or pnuemococal polysaccharide vaccine\r\n      ","sponsor":"The HIV Netherlands Australia Thailand Research Collaboration","sponsor_type":"Other","conditions":"HIV","interventions":[{"intervention_type":"Biological","name":"Biological: valent pneumococcal conjugated vaccine","description":"Dosage: 0.5 ml per dose Administration: intramuscular injection Location: left deltoid area x 1 injection Frequency: depend on first dose of vaccination. If 2-6 months of age, vaccination at month 0, 2, and 4. If 7-23 months of age, vaccination at month 0 and 2. If 2-9 years of age, vaccination at month 0. If patient is HIV positive, vacciation months 0 and 2 if age is 2-9 years."}],"outcomes":[{"outcome_type":"primary","measure":"immunogenicity","time_frame":"28 days","description":"Proportion of children with PCV serotype - specific IgG antibody at 28 days after completion of primary series of vaccination."},{"outcome_type":"secondary","measure":"Safety","time_frame":"28 days","description":"Number of adverse events after PCV administration"},{"outcome_type":"secondary","measure":"compare serotype","time_frame":"28 days","description":"Compare proportion of PCV serotype - specific IgG antibody in HIV - infected children by baseline clinical staging, CD4 and viral load."}]}
{"nct_id":"NCT01270607","start_date":"2010-04-30","phase":"N/A","enrollment":10,"brief_title":"Acupuncture and Pain Processing","official_title":"Acupuncture and Pain Processing","primary_completion_date":"2010-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-08-31","last_update":"2013-05-23","description":"The purpose of this study is to test the hypothesis that acupuncture will reduce Fibromyalgia pain, via alterations in the processing of pain in the central nervous system.","other_id":"SU-04132010-5662","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age 18-50\r\n\r\n          2. Fibromyalgia patient OR healthy control\r\n\r\n          3. No current opioid use\r\n\r\n          4. Patients: must have had Fibromyalgia for 6 months or longer\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Inflammatory disorder (lupus, rheumatoid arthritis)\r\n\r\n          2. Current untreated depression\r\n\r\n          3. Active infection\r\n\r\n          4. Healthy controls: pain disorder or major medical condition that in the discretion of\r\n             the investigator interfere with the validity of the study\r\n\r\n          5. Heart disease or use of a cardiac pacemaker\r\n      ","sponsor":"Stanford University","sponsor_type":"Other","conditions":"Fibromyalgia","interventions":[{"intervention_type":"Procedure","name":"Procedure: Acupuncture","description":"Treatment given twice per week for 4 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Pain rating to Temporal Summation and Diffuse Noxious Inhibitory Control (DNIC) as measured by a visual analogue scale","time_frame":"Measured at last study acupuncture session (6 weeks post enrollment)"},{"outcome_type":"secondary","measure":"Change in Fibromyalgia Impact Questionnaire","time_frame":"Change from first to last study treatment session (6 weeks)"},{"outcome_type":"secondary","measure":"Change in Brief Pain Inventory","time_frame":"Change from first to last treatment session (6 weeks)"}]}
{"nct_id":"NCT01112605","start_date":"2010-04-30","enrollment":50,"brief_title":"Standard Deviation of the Distance Between the Sural Nerve and Achilles Tendon by Ultrasound","primary_completion_date":"2010-05-31","study_type":"Observational","rec_status":"Completed","completion_date":"2010-05-31","last_update":"2011-07-19","description":"The purpose of this study is to define the standardization of the distance between the Sural nerve & Achilles tendon, in otherwise healthy persons and athletes.","other_id":"MMC09155-09CTIL","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":60,"population":"otherwise healthy persones, age 18-60, community sample.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  healthy\r\n\r\n          -  age 18-60\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  known bone or muscle disease\r\n\r\n          -  major trauma to the leg or ankle in present or past\r\n\r\n          -  surgery of leg or ankle in the past\r\n\r\n          -  mental disabilities\r\n      ","sponsor":"Meir Medical Center","sponsor_type":"Other","conditions":"Healthy","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"distance between the Sural nerve & the Achilles tendon","time_frame":"day 1","description":"one time measurment of the distance between the sural nerve & the Achilles tendon, using an US device."}]}
{"nct_id":"NCT01104857","start_date":"2010-04-30","phase":"N/A","enrollment":30,"brief_title":"Respiratory Muscle Dysfunction in Critically Ill Patients","primary_completion_date":"2016-04-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2016-04-30","last_update":"2015-06-10","description":"Respiratory muscle dysfunction in critically ill patients is associated with elevated morbidity, including prolonged weaning from mechanical ventilation. The causes for respiratory muscle dysfunction in these patients is poorly understood and no effective treatment is available. The general hypothesis of the present study is that in critically ill mechanically ventilated subjects respiratory muscle dysfunctions results from loss of myosin induced by activation of proteolytic cascades.","other_id":"Diam1","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":90,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Severe sepsis / septic shock\r\n\r\n          -  Clinical reason for laparotomy\r\n\r\n          -  > 18 years\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  No informed consent\r\n\r\n          -  Medical history of myopathy\r\n\r\n          -  Unintended weight loss before ICU admission\r\n\r\n          -  Pregnancy\r\n\r\n          -  Chronic use of corticosteroids\r\n      ","sponsor":"University Medical Center Nijmegen","sponsor_type":"Other","conditions":"Sepsis|Mechanical Ventilation","interventions":[{"intervention_type":"Procedure","name":"Procedure: diaphragm muscle biopsy","description":"Biopsy is obtained for biochemical analysis"},{"intervention_type":"Procedure","name":"Procedure: Diaphragm muscle biopsy","description":"Biopsy is obtained for biochemical analysis"}],"outcomes":[{"outcome_type":"primary","measure":"Diaphragm muscle myosin content","time_frame":"1 day"},{"outcome_type":"primary","measure":"Markers for inflammation","time_frame":"1 day","description":"Inflammatory mediators are measured in plasma and diaphragm at the moment the diaphragm biopsy is obtained."},{"outcome_type":"primary","measure":"Markers for activation of proteolytic pathway in the diaphragm","time_frame":"1 day","description":"Biochemical analysis is targeted towards activation of several proteolytic pathways (proteasome, lysosmal)."},{"outcome_type":"secondary","measure":"length of ICU stay","time_frame":"6 months","description":"Length of ICU stay obtained from medical record"},{"outcome_type":"secondary","measure":"Length of mechanical ventilation","time_frame":"6 months","description":"Duration of mechanical ventilation is assesssed within 6 months after obtaining diaphragm biopsy."}]}
{"nct_id":"NCT01951651","start_date":"2010-04-30","phase":"Phase 4","enrollment":24,"brief_title":"Effect of Exenatide on Liver and Heart Fat and Inflammation","official_title":"Effect of Exenatide Treatment on Myocardial Fat Content, Left Ventricular Function, and Vascular Inflammation in Patients With Type 2 Diabetes Mellitus","primary_completion_date":"2012-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-03-31","last_update":"2016-05-16","description":"The purpose of this study is to examine the effect of exenatide on liver and heart (myocardial) fat and inflammation.","other_id":"H-26030","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":30,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patients must be able to communicate meaningfully with the investigator and must be\r\n             legally competent to provide written informed consent.\r\n\r\n          2. Patients may be of either sex. Female patients must be non-lactating and must either\r\n             be at least two years post-menopausal, or be using adequate contraceptive precautions.\r\n\r\n          3. Patients must range in age from 30 to 70 years, inclusive.\r\n\r\n          4. Patients must meet the American Diabetes Association (ADA) criteria (ADA 1997\r\n             Criteria: fasting plasma glucose greater than or equal to 126 mg/dl) for the diagnosis\r\n             of type 2 diabetes mellitus.\r\n\r\n          5. Patients must be on diet therapy and/or metformin treatment for type 2 diabetes\r\n             (stable dose)and have a fasting plasma glucose concentration between 126 and 260 mg/dl\r\n\r\n          6. Patients must have Hematocrit greater than 34 vol%.\r\n\r\n          7. Subjects whose body weight has been stable over the three months prior to study\r\n             enrollment will be included.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients must not have type 1 diabetes.\r\n\r\n          2. Patients must not have a fasting plasma glucose greater than 260 mg/dl.\r\n\r\n          3. Patients must not have received a thiazolidinedione for at least 3 months prior to\r\n             randomization.\r\n\r\n          4. Patients must not be on insulin treatment or have received insulin for more than one\r\n             week within the previous year prior to entry. Patients should not be on sulfonylureas,\r\n             sitagliptin, or exenatide treatment.\r\n\r\n          5. Patients taking systemic glucocorticoids or other medications known to affect glucose\r\n             tolerance are excluded.\r\n\r\n          6. Patients taking medications that affect gastrointestinal motility will be excluded.\r\n\r\n          7. Patients with a history of Congestive Heart Failure, or clinically significant\r\n             cardiac, liver or kidney disease (creatinine greater than 1.5 mg/dl).\r\n      ","sponsor":"Baylor College of Medicine","sponsor_type":"Other","conditions":"Type 2 Diabetes Mellitus","interventions":[{"intervention_type":"Drug","name":"Drug: Exenatide","description":"Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."},{"intervention_type":"Drug","name":"Drug: Glipizide","description":"Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."}],"outcomes":[{"outcome_type":"primary","measure":"Myocardial Fat Content","time_frame":"6 months","description":"Myocardial fat content following intervention as measured by magnetic resonance imaging and spectroscopy (MRS) in patients with type 2 diabetes."},{"outcome_type":"primary","measure":"Hepatic Fat Content","time_frame":"6 months","description":"Hepatic fat content following intervention in patients with type 2 diabetes"},{"outcome_type":"secondary","measure":"Left Ventricular Ejection Fraction (LVEF)(%).","time_frame":"6 months","description":"Left Ventricular Ejection Fraction following intervention as measured by magnetic resonance imaging in patients with type 2 diabetes."},{"outcome_type":"secondary","measure":"Monocyte Inflammatory Protein Nuclear Factor Kappa-B (NFkappaB) (%)","time_frame":"6 months","description":"The percentage change in monocyte inflammatory proteins NFkappaB (%) from baseline."}]}
{"nct_id":"NCT01132235","start_date":"2010-04-30","phase":"Phase 4","enrollment":20,"brief_title":"An Open-label Study to Evaluate the Efficacy of Re-treatment for Patients With a History of Etanercept Use","official_title":"An Open-label Study to Evaluate the Efficacy of Re-treatment for Patients With a History of Etanercept Use","primary_completion_date":"2010-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2010-12-31","last_update":"2010-05-28","description":"The purpose of this study is to evaluate the efficacy of re-treatment with etanercept 50mg subcutaneous injections twice weekly for 12 weeks in subjects who have previously been treated etanercept and efficacy diminished.","other_id":"ENBRECAP2009","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subjects with psoriasis who have previously been treated with etanercept for a minimum\r\n             of 6 months and discontinued treatment due to loss of efficacy. Every attempt will be\r\n             made to obtain loss of efficacy history from the subject's medical chart;when\r\n             etanercept was commenced and terminated and description of patient's psoriasis on\r\n             termination and details of new treatment commenced. Subjects must have failed their\r\n             latest psoriasis treatment after a period of three months. This will be measured as a\r\n             PGA of  3.\r\n\r\n          -  There is no specific requirement as to when prior treatment with etanercept occurred\r\n             and no requirement as to what type of treatment(s) used between initial and subsequent\r\n             treatments.\r\n\r\n          -  Are  18 years of age\r\n\r\n          -  PGA  3\r\n\r\n          -  BSA minimum of 5%\r\n\r\n        Tuberculosis inclusion criteria\r\n\r\n          -  Have no history of latent or active TB prior to screening.\r\n\r\n          -  Have no signs or symptoms suggestive of active TB upon medical history and/or physical\r\n             examination.\r\n\r\n          -  Have had no recent close contact with a person with active TB.\r\n\r\n          -  Within 1 month prior to the first administration of study have a negative tuberculin\r\n             skin test.\r\n\r\n               -  The ability to give written informed consent and comply with study procedures.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Current enrollment in any other investigational device or investigational drug\r\n             trial(s), or receipt of any other investigational agent(s) within 28 days before\r\n             baseline visit.\r\n\r\n          -  Known hypersensitivity to Enbrel (etanercept) or any of its components or known to\r\n             have antibodies to etanercept.\r\n\r\n          -  Latex sensitivity [NB: only applicable if they are using prefilled syringe or\r\n             prefilled SureClick autoinjector presentations]\r\n\r\n          -  Prior or concurrent use of cyclophosphamide therapy\r\n\r\n          -  Concurrent sulfasalazine therapy.\r\n\r\n          -  A positive HBV test or known history of any other immuno-suppressing disease.\r\n\r\n          -  Any mycobacterial disease or high risk factors for tuberculosis (TB), such as family\r\n             member with TB, positive purified protein derivative (PPD) or taking anti-tuberculosis\r\n             medication.\r\n\r\n          -  Active or chronic infection within 4 weeks before screening visit, or between the\r\n             screening and baseline visits.\r\n\r\n          -  History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection and\r\n             Hepatitis C, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome,\r\n             chronic recurring infections or active TB, or other opportunistic infections\r\n\r\n          -  If etanercept was previously discontinued due to a serious adverse event\r\n\r\n          -  Severe comorbidities (diabetes mellitus requiring insulin; CHF of any severity; or\r\n             myocardial infarction, cerebrovascular accident or transient ischemic attack within 6\r\n             months of screening visit; unstable angina pectoris; uncontrolled hypertension\r\n             (sitting systolic BP <80 mm Hg or > 160 or diastolic BP > 100 mm Hg); oxygen-dependent\r\n             severe pulmonary disease; history of cancer within 5 years [other than resected\r\n             cutaneous basal or squamous cell carcinoma of the skin or in situ cervical cancer])\r\n\r\n          -  Systemic lupus erythematosus, history of multiple sclerosis, transverse myelitis,\r\n             optic neuritis or seizure disorder.\r\n\r\n          -  Use of a live vaccine 90 days prior to screening visit, or concurrent use of a live\r\n             vaccine.\r\n\r\n          -  Any condition or circumstances judged by the patient's physician [or the investigator\r\n             or medically qualified study staff] to render this clinical trial detrimental or\r\n             otherwise unsuitable for the patient's participation.\r\n\r\n          -  Female subjects who are pregnant, nursing or planning pregnancy (both men and women)\r\n             and not using acceptable methods of birth control during the trial (hormonal,\r\n             barriers, abstinence).\r\n\r\n          -  Women who are breast feeding\r\n\r\n        History of non-compliance with other therapies.\r\n\r\n          -  History of alcohol abuse within the last 12 months\r\n\r\n          -  Concurrent use of anakinra\r\n\r\n          -  Subjects who cannot discontinue any of the drugs below for 2 weeks prior to the\r\n             baseline visit or during the study;\r\n\r\n        A two week wash out period is appropriate as it would be unethical to expect subjects whose\r\n        disease if flaring to remain untreated for a longer period of time. The first dose of\r\n        etanercept will be administered two weeks after the last biologic dose.\r\n\r\n          -  Immunosuppressants, antimalarials, or sulfasalazine.\r\n\r\n          -  Other Ani-TNFs\r\n\r\n          -  Cyclosporine\r\n\r\n          -  Efalizumab\r\n\r\n          -  Azathioprine\r\n\r\n          -  Hydroxyurea\r\n\r\n          -  Live vaccines\r\n\r\n          -  Tacrolimus\r\n\r\n          -  Oral retinoids (isotretinoin,acitretin,bexarotene)\r\n\r\n          -  Ultra violet light therapies\r\n      ","sponsor":"Florida Academic Dermatology Centers","sponsor_type":"Other","conditions":"Psoriasis","interventions":[{"intervention_type":"Biological","name":"Biological: etanercept","description":"50mgs subcutaneous injections twice a week for 12 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"The proportion of patients achieving a Physician's Global Assessment (PGA) score of minimal (1) or clear (0) at week 12.","time_frame":"12 weeks","description":"Physician's Global Assessment (PGA) score of minimal (1) or clear (0) at week 12 will measure efficacy of retreatment with etanercept"}]}
{"nct_id":"NCT01259128","start_date":"2010-04-30","phase":"Phase 3","enrollment":32,"brief_title":"Study to Investigate the Safety and Pharmacokinetics of SER120 Nasal Spray in Elderly Patients With Nocturia","official_title":"A Phase III Randomized, Open-Label, Multicenter Study to Investigate the Safety and Pharmacokinetics of SER120 Nasal Spray Formulations in Elderly Patients ( 75 Years Old) With Nocturia","primary_completion_date":"2010-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-11-30","last_update":"2020-11-17","description":"The purpose of this study is to determine if SER120 nasal spray is well tolerated in 75 years or older nocturic patients.","other_id":"SPC-SER120-ELD-2010-01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":75,"maximum_age":95,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male & female greater or equal to 75 years of age, history of nocturia\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  CHF, Diabetes, Diabetes Insipidus, Renal Insufficiency, Heptatic Insufficiency,\r\n             Incontinence, Illness requiring steroid, current or past urologic maliganancy,\r\n             nephrotic syndrome\r\n\r\n          -  Unexplained pelvic masses\r\n\r\n          -  Urinary bladder surgery or radiotherapy\r\n\r\n          -  Sleep apnea\r\n      ","sponsor":"Serenity Pharmaceuticals, Inc.","sponsor_type":"Industry","conditions":"Nocturia","interventions":[{"intervention_type":"Drug","name":"Drug: SER120 Nasal Spray 500 ng/day","description":"SER120 Level 1"},{"intervention_type":"Drug","name":"Drug: SER120 nasal spray 750 ng/day","description":"SER120 (750 ng/day)"}],"outcomes":[{"outcome_type":"primary","measure":"Serum Sodium Levels at Baseline and During Treatment","time_frame":"baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57","description":"Mean serum sodium reported at baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57."},{"outcome_type":"secondary","measure":"Change in Mean Nocturic Episodes Per Night","time_frame":"Mean value at Week 8 minus mean value at baseline","description":"Change in mean nocturic episodes per night between baseline and Week 8"},{"outcome_type":"secondary","measure":"Percent of Participants With Greater or Equal to 50% Reduction in the Number of Nocturic Episodes","time_frame":"8 weeks","description":"Percent of participants with greater or equal to 50% reduction in number of nocturic episodes at Week 8 compared to Baseline"}]}
{"nct_id":"NCT01112072","start_date":"2010-04-30","phase":"Phase 3","enrollment":160,"brief_title":"Corneal Collagen Crosslinking and Intacs for Keratoconus and Ectasia","official_title":"Randomized Study of Safety and Effectiveness of Corneal Collagen Crosslinking and Intacs for Treatment of Keratoconus and Corneal Ectasia","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2021-12-31","last_update":"2021-05-20","description":"This study will determine the efficacy of corneal collagen crosslinking (CXL) combined with Intacs for the treatment of keratoconus and corneal ectasia. The goal of CXL is to decrease the progression of keratoconus, while Intacs has been shown to decrease corneal steepness in keratoconus. This study will attempt to determine the relative efficacy of the two procedures either performed at the same session versus CXL performed 3 months after Intacs.","other_id":"CLEI-Intacs-CXL","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":21,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  21 years of age or older\r\n\r\n          -  Having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery\r\n             (e.g., LASIK, photorefractive keratectomy [PRK], or epi-LASIK)\r\n\r\n          -  Subjects who meet the manufacturer's nomogram recommendations for Intacs segments\r\n\r\n          -  Topography consistent with keratoconus or post-surgical corneal ectasia.\r\n\r\n          -  BSCVA worse than 20/20 (<55 letters on ETDRS chart)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Eyes classified as either normal, atypical normal, or keratoconus suspect on the\r\n             severity grading scheme.\r\n\r\n          -  Corneal pachymetry  400 microns at the thinnest point measured by Pentacam in the\r\n             eye(s) to be treated when the isotonic riboflavin solution is used or  300 microns\r\n             when the hypotonic riboflavin us used, provided that the corneal thickness after\r\n             treatment with the hypotonic riboflavin solution is > 400 microns. Corneal pachymetry\r\n              450 microns at the proposed insertion site for the Intacs\r\n\r\n          -  Previous ocular condition (other than refractive error) in the eye(s) to be treated\r\n             that may predispose the eye for future complications\r\n\r\n          -  History of corneal disease\r\n\r\n          -  History of chemical injury or delayed epithelial healing in the eye(s) to be treated.\r\n\r\n          -  Pregnancy (including plan to become pregnant) or lactation during the course of the\r\n             study\r\n\r\n          -  A known sensitivity to study medications\r\n\r\n          -  Subjects with nystagmus or any other condition that would prevent a steady gaze during\r\n             the CXL and Intacs treatment or other diagnostic tests.\r\n\r\n          -  Subjects with a current condition that, in the investigator's opinion, would interfere\r\n             with or prolong epithelial healing.\r\n      ","sponsor":"Cornea and Laser Eye Institute","sponsor_type":"Other","conditions":"Keratoconus|Corneal Ectasia","interventions":[{"intervention_type":"Drug","name":"Drug: Riboflavin","description":"Corneal epithelium removed followed by riboflavin drop administration every 2 minutes for 30 minutes followed by UV light exposure with additional riboflavin administration every 2 minutes for 30 minutes. Subjects will be randomized to receive Intacs placement either immediately before CXL or 3 months before CXL."}],"outcomes":[{"outcome_type":"primary","measure":"Maximum keratometry","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Best Corrected Visual Acuity","time_frame":"1 year"}]}
{"nct_id":"NCT01493934","start_date":"2010-04-30","phase":"Phase 1/Phase 2","enrollment":12,"brief_title":"Development of a Fast Measurement Technique of Insulin Resistance in Human","official_title":"Development of a Fast Measurement Technique of Insulin Resistance in Human, With 123-6-deoxy-6 Iodo-D-glucose, a New Tracer of Glucose Transport","primary_completion_date":"2013-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-03-31","last_update":"2016-02-24","description":"Insulin resistance, characterised by a depressed cellular sensitivity to insulin in insulin-sensitive organs, is a central feature of the metabolic syndrome. In people with no diabetes mellitus, the presence of metabolic syndrome leads to an increase of mortality, whatever the cause, but, as a majority, cardiovascular diseases. In patients with type 2 diabetes mellitus, the presence of a metabolic syndrome leads to an increase in major adverse cardiovascular events. The prevalence of metabolic syndrome is led to grow in a near future, because of the increase of diabetes mellitus and obesity prevalence. Actually, there is no simple tool to measure insulin resistance. The gold standard technique remains the hyperinsulinemic euglycemic clamp. However, the complexity and length of this technique render it unsuitable for routine clinical use. Many methods or index have been proposed to assess insulin resistance in human, but none have shown enough relevance to be used in clinical use. Within the investigators U877 INSERM team, the investigators previously performed in vivo biodistribution studies with 6-DIG (6-deoxy-6-iodo-D-glucose), a new tracer of glucose transport, radiolabelled with123 iodine, with and without insulin, on the one hand in genetically diabetic mice (db/db), consequently having a severe insulin resistance and in the other hand in rats with acquired insulin resistance after a \"fructose diet\". The investigators have demonstrated that 6-DIG is able to identify in vivo slight glucose transport variations in insulin sensible organs. Then, the investigators developed a fast and simple imaging protocol with a small animal gamma camera, which allows the obtaining of an insulin resistance index for each organ, directly transferable to human. The investigators project is to transfer to human this measurement technique, perfectly validated in animal. The main goal of this monocentric phase I-II study is to evaluate the tolerance to the insulin resistance measurement technique with 6DIG scintigraphy, in healthy volunteers and in diabetic patients. The investigators plan to enrol 6 healthy volunteers and 6 type 2 diabetic patients. The investigators secondary goals will be to evaluate feasibility and reproducibility of the measurement technique, to follow pharmacokinetic and to assess efficacy of 6-DIG to measure insulin resistance.","other_id":"C09-07","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":35,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy volunteers\r\n\r\n          -  Aged between 35 et 60 years old\r\n\r\n          -  Body mass index between 20 and 25\r\n\r\n          -  Waist measurement < 94 cm for men and < 80 cm for women\r\n\r\n          -  Normal basal glycemia, between 3,8 and 5,8 mmol/l\r\n\r\n          -  Normal basal insulinemia, between 3 and 13 UI/ml\r\n\r\n          -  HbA1c < 6%\r\n\r\n          -  Total cholesterol < 2 g/l\r\n\r\n          -  LDL cholesterol < 1,6 g/l\r\n\r\n          -  HDL cholesterol 0,4 g/l for men and 0,5 g/l for women\r\n\r\n          -  Triglyceride level < 1,5 g/l\r\n\r\n          -  For women not menopausal since at last one year or not surgically sterilised:\r\n\r\n        On-going contraception, physical or hormonal, excepted local methods (spermicidal,\r\n        diaphragm, condom, cape)\r\n\r\n          -  Type 2 diabetic patients\r\n\r\n          -  Aged between 35 et 60 years old\r\n\r\n          -  Stable type 2 diabetes mellitus: no ketoacidosis sign during last month\r\n\r\n          -  HbA1c between 6 and 8% during the 3 months before study inclusion\r\n\r\n          -  Monotherapy by metformin or diet only\r\n\r\n          -  For women not menopausal since at last one year or not surgically sterilised:\r\n\r\n          -  On-going contraception, physical or hormonal, excepted local methods (spermicidal,\r\n             diaphragm, condom, cape)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Diabetes mellitus previously known\r\n\r\n          -  Other on-going progressive illness\r\n\r\n          -  Psychiatric illness, needing a chronic treatment\r\n\r\n          -  Previous history of myocardial infarction, coronary artery disease, cardiac rhythm\r\n             troubles, stroke, epilepsy, cranial trauma, pituitary surgery, disease likely to\r\n             reduce the ability of absorption, diffusion or excretion of the radiotracer.\r\n\r\n          -  Severe hypertension defined by par SAP > 180 mmHg and/or DAP > 110 mmHg\r\n\r\n          -  Allergy to one of the components of the products used during the study\r\n\r\n          -  Nuclear medicine examination during the 30 days prior to study inclusion\r\n\r\n          -  Treatment likely to interfere with glucose metabolism\r\n\r\n          -  Alcohol or drug intoxication\r\n\r\n          -  Vegetarian or restrictive low-calory diet,\r\n\r\n          -  Pregnant, parturient or breast-feeding women,\r\n\r\n          -  Inappropriate way of life\r\n\r\n          -  Type 2 diabetic patients.\r\n\r\n          -  Previous history of myocardial infarction\r\n\r\n          -  Severe hypertension defined by par SAP > 180 mmHg and/or DAP > 110 mmHg\r\n\r\n          -  Previous history of coronary artery disease, cardiac rhythm troubles, stroke,\r\n             epilepsy, cranial trauma, pituitary surgery, disease likely to reduce the ability of\r\n             absorption, diffusion or excretion of the radiotracer.\r\n\r\n          -  Psychiatric illness, needing a chronic treatment\r\n\r\n          -  On-going insulin treatment\r\n\r\n          -  On-going treatment other than metformin, likely to interfere with glucose metabolism\r\n\r\n          -  Previous history of disease likely to reduce the ability of absorption, diffusion or\r\n             excretion of the radiotracer\r\n\r\n          -  Allergy to one of the components of the products used during the study\r\n\r\n          -  Nuclear medicine examination during the 30 days prior to study inclusion\r\n\r\n          -  Alcohol or drug intoxication\r\n\r\n          -  Vegetarian or restrictive low-calory diet,\r\n\r\n          -  Pregnant, parturient or breast-feeding women,\r\n\r\n          -  Inappropriate way of life\r\n      ","sponsor":"Institut National de la Sant Et de la Recherche Mdicale, France","sponsor_type":"Other","conditions":"Type 2 Diabetes Mellitus","interventions":[{"intervention_type":"Drug","name":"Drug: injection of 6-DIG","description":"Unique injection dose of 92.5 MBq"}],"outcomes":[{"outcome_type":"primary","measure":"Change of glycemia","time_frame":"Before inclusion in clinical trial, Before radiotracer injection, After radiotracer injection (time: 30s, 1', 2',5',10',15',25', 1 hour, 2 hours, 4 hours, 8 hours, 24 hours)","description":"Assessment of tolerance to insulin resistance measurement technique with 6-DIG scintigraphy, in healthy volunteers\r\nclinical tolerance to 6-DIG infusion\r\nclinical and biological tolerance to insulin infusion\r\nevaluation of dosimetry"},{"outcome_type":"secondary","measure":"insulinemia","time_frame":"Before inclusion in clinical trial, Before radiotracer injection, After radiotracer injection (time: 30s, 1', 2',5',10',15',25', 1 hour, 2 hours, 4 hours, 8 hours, 24 hours)"},{"outcome_type":"secondary","measure":"clinical side effects","time_frame":"Before inclusion in clinical trial, Before radiotracer injection, After radiotracer injection (time: 30s, 1', 2',5',10',15',25', 1 hour, 2 hours, 4 hours, 8 hours, 24 hours)","description":"hypoglycemia symptoms"},{"outcome_type":"secondary","measure":"dosimetry","time_frame":"during the 24 hours following injection of 6-DIG","description":"organs biodistribution of radioactivity"},{"outcome_type":"secondary","measure":"insulin resistance","time_frame":"0-15 minutes following 6-DIG infusion","description":"scintigraphic measurement of glucose transport in heart before and after infusion of insulin"}]}
{"nct_id":"NCT01750372","start_date":"2010-04-30","enrollment":1572,"brief_title":"A Client-Based Outcome System for Individuals With Lower Limb Amputation","official_title":"A Client-Based Outcome System for Individuals With Lower Limb Amputation","primary_completion_date":"2016-03-31","study_type":"Observational","rec_status":"Completed","completion_date":"2016-03-31","last_update":"2016-05-18","description":"Standardized outcome measures can be used to document patient health outcomes and improve treatment of those requiring prosthetic and orthotic (O&P) services. Though numerous instruments have been developed, existing measures of O&P outcomes have serious shortcomings including limited evidence that the scores are responsive to clinical changes. The investigators are developing the Prosthetic Limb Users Survey-Mobility (PLUS-M) using modern measurement methods to be a brief, precise and flexible measure of mobility for persons with lower limb amputation (LLA). The investigators propose the following objectives to achieve this goal. Key objective 1: develop a measure (item bank) for measuring mobility in persons with lower limb loss Key objective 2: study health profiles of lower limb prosthetic users Key objective 3: validate the measure in a longitudinal study of people receiving replacement prosthetic limbs Key objective 4: study longitudinal health patterns of persons with lower limb amputation","other_id":"38227-G","observational_model":"Case-Only","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Persons with lower limb amputation living in the United States","criteria":"\n        Inclusion Criteria:\r\n\r\n        (1) be 18 years of age or older; (2) have a unilateral or bilateral amputation of the lower\r\n        limb between the hip and knee or between the knee and ankle; (3) own and use a lower limb\r\n        prostheses; (4) and be able to read, write, and understand spoken English.\r\n\r\n        Exclusion Criteria:\r\n\r\n        (1) do not currently use or do not intend to be fitted for a lower limb prosthesis; or (2)\r\n        appear to have moderate to severe cognitive impairment, as evidenced by inconsistent\r\n        responding to the study instruments.\r\n      ","sponsor":"University of Washington","sponsor_type":"Other","conditions":"Amputation","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Prosthetic Limb Users Survey of Mobility (PLUS-M)","time_frame":"Single time point","description":"PLUS-M is a self-reported measure of prosthetic mobility."},{"outcome_type":"secondary","measure":"Prosthesis Evaluation Questionnaire - Mobility Subscale (PEQ-MS) delivery of orthotics and prosthetics (O&P) services for persons with LLA.","time_frame":"Single time point","description":"The PEQ-MS is a self-reported measure of prosthetic mobility."},{"outcome_type":"secondary","measure":"Patient Reported Outcomes Measurement Information Systems (PROMIS) brief profile","time_frame":"Single time point","description":"The Patient Reported Outcomes Measurement Information System (PROMIS) is a suite of reliable, precise, and meaningful self-report instruments designed to assess patients' health. PROMIS-29 is a 29-item survey designed to evaluate patients in seven health domains: physical function, anxiety, depression, fatigue, sleep disturbance, social role-participation, and pain interference."},{"outcome_type":"secondary","measure":"Activities Specific Balance Confidence Scale (ABC)","time_frame":"Single time point","description":"The ABC is a self-reported measure of balance confidence."}]}
{"nct_id":"NCT01520623","start_date":"2010-04-30","phase":"N/A","enrollment":70,"brief_title":"Complement and Graft-versus-host Disease","official_title":"Role of Complement System in Human Allogeneic Haematopoietic Stem Cell Transplantation","primary_completion_date":"2013-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-07-31","last_update":"2015-04-10","description":"Allogeneic haematopoietic stem cell transplantation (HSCT) often remains the only curative treatment for haematological malignancies. The anti-leukaemic effect of allogeneic HSCT, called the GvL (Graf-versus-Leukemia) effect, is often associated to the development of an immune response against healthy recipient cells leading to a graft-versus-host disease (GvHD) in 20 to 70% of allogeneic HSCT. Acute GvHD, that usually targets the skin, the gastrointestinal (GI) tract and the liver, is an important cause of morbidity and mortality after allogeneic HSCT, particularly in the case of GI GvHD. The main goal of the research in the field of allogeneic HSCT is to determine strategies that could decrease the risk of GvHD without affecting the GvL effect. According to GVHD experimental models, it is likely that GvL but not GvHD may occur in the absence of inflammatory signals induced by the transplant-associated conditioning. Based on this hypothesis, we have chosen to analyse the role of Complement system in patients who received allogeneic HSCT. Indeed, Complement system is a major actor of inflammation and in the generation of tissue destruction, both of which are involved in the physiopathology of GVHD. Furthermore, it might be a potential target of some available inhibitory drugs (purified C1-Inhibitor, anti-C5 antibodies) in a preventive or curative manner in such patients. Preliminary data obtained from 34 allografted patients in our institution suggest that Complement activation by the classical pathway is correlated to the occurrence of GI GVHD. The goal of our current project, in order to confirm these preliminary results in a larger series, is to explore Complement system activation in patients who received allogeneic HSCT in three Adult Hematology departments in Paris fot two years and to correlate the biological results to the clinical events occurring after HSCT.","other_id":"CRC 08025","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Allografted patients with myeloablative conditioning for an haematological malignancy\r\n\r\n          -  Age > 18 years old and < 65 years.\r\n\r\n          -  The patient must have access to social insurance according to local regulations.\r\n\r\n          -  Patient must give a written informed consent (personally signed and dated) before\r\n             completing any study related procedure\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Age < 18 years old and > 65 years\r\n\r\n          -  Patient with active infection HIV, HTLV1, Hepatite B ou C\r\n\r\n          -  Uncontrolled infection(s), (i.e. documented bacterial, parasitical, or fungal\r\n             infection).\r\n\r\n          -  Patient with lupus\r\n\r\n          -  Patient with transaminases > 5N, TP<30% with Facteur V < 30% before allogreffe\r\n\r\n          -  Creatinine clearance < 50ml/min\r\n\r\n          -  Absence of any psychological condition potentially hampering signing informed consent\r\n\r\n          -  Patient refused to sign informed consent\r\n      ","sponsor":"Assistance Publique - Hpitaux de Paris","sponsor_type":"Other","conditions":"Allografted With Myeloablative Conditioning","interventions":[{"intervention_type":"Other","name":"Other: Serum concentration /Serum inflammatory","description":"Allografted patients with myeloablative conditioning for an haematological malignancy. Patients will be followed for at least 12 months after transplantation and blood samples drawn before conditioning and once a week for 12 weeks after transplantation to analyze the serum concentration of Complement factors (C3, C4, B factor), Complement regulatory proteins (C1-inhibitor, I and H Factors) and analysis of the surface expression of Complement regulatory molecules such as CD46, CD55 and CD59 and the serum inflammatory cytokine levels"}],"outcomes":[{"outcome_type":"primary","measure":"Activation of the complement system and the development of acute gut GvHD","time_frame":"12 weeks","description":"Assessment of the activation of the complement system after human allogeneic stem cell transplantation and of its potential correlation with the development of acute gut GvHD"},{"outcome_type":"secondary","measure":"Overall survival","time_frame":"2 years","description":"Overall Survival at 3, 6, 9 , 12 and 24-month Post HCST"},{"outcome_type":"secondary","measure":"Overall survival without relapse","time_frame":"2 Years","description":"Relapse"}]}
{"nct_id":"NCT01162655","start_date":"2010-04-30","phase":"N/A","enrollment":110,"brief_title":"Cognitive-Behavioural Therapy (CBT) for Insomnia Via Internet or Telehealth","official_title":"Delivery of Cognitive-Behavioral Treatment for Insomnia Via Telehealth or Internet","primary_completion_date":"2013-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-06-30","last_update":"2017-05-30","description":"Cognitive-Behavioural Therapy (CBT) is an effective treatment for chronic insomnia, which is a prevalent and costly problem. This pilot study will compare the effectiveness of two brief (6 week) psychological interventions delivered to residents of rural Manitoba using Telehealth or an interactive Internet-based platform. It is hypothesized that a) participants in the Telehealth condition will report significantly greater improvements in sleep parameters(e.g., sleep efficiency, time awake in bed, sleep-onset latency),insomnia severity, and daytime fatigue than those in the Internet condition and that b)participants in the Telehealth condition will show better adherence to treatment and greater satisfaction with treatment than those in the Internet condition.","other_id":"H2009:110","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Must be residents of rural Manitoba (Canada)\r\n\r\n          -  Must meet research diagnostic criteria for insomnia\r\n\r\n          -  Must have access to a computer and high-speed internet\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Comorbid conditions (medical and psychiatric) must be stable\r\n      ","sponsor":"University of Manitoba","sponsor_type":"Other","conditions":"Insomnia","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Cognitive-behavioral therapy for Insomnia (CBT)","description":"6-week course of CBT delivered either using internet or telehealth"}],"outcomes":[{"outcome_type":"primary","measure":"Insomnia Severity","time_frame":"6 weeks","description":"The primary outcome measure will be insomnia severity, as assessed by the Insomnia Severity Index (ISI; Morin, 2003), a 6-item self-report measure of impairment due to sleep difficulties"},{"outcome_type":"secondary","measure":"Sleep diary data","time_frame":"6 weeks","description":"Sleep diaries are a standard daily outcome measure for insomnia. The version used here (Morin, 1993) includes information regarding total sleep time, sleep-onset latency, sleep-efficiency, number of night awakenings, time awake in then night, sleep quality, and frequency of use of sleep medications."}]}
{"nct_id":"NCT01140633","start_date":"2010-04-30","enrollment":46,"brief_title":"Novel Measures and Theory of Pediatric Antiretroviral Therapy Adherence in Uganda","official_title":"Novel Measures and Theory of Pediatric Antiretroviral Therapy Adherence in Uganda","primary_completion_date":"2011-01-31","study_type":"Observational","rec_status":"Completed","completion_date":"2012-08-31","last_update":"2013-09-02","description":"Current measures of adherence detect problems weeks to months after they occur. Because the HIV virus rapidly begins replicating and mutating in the absence of effective antiretroviral therapy, treatment failure may develop before an intervention can be deployed. Real-time objective adherence monitoring could redirect efforts from a reactive response to the proactive prevention of treatment failure. Because adherence is so closely associated with viral suppression, accurate adherence monitoring could also strategically limit viral monitoring only to those patients at a defined risk for viral rebound. This observational study is assessing a wireless adherence monitoring device and mobile phone-based adherence data collection among caregivers of children under the age of ten years in Mbarara, Uganda. It involves both quantitative and qualitative measures of the feasibility and acceptability of these measures, as well as circumstances of adherence lapses and other individual and cultural factors affecting adherence. The qualitative data will be used to explore models of adherence behavior, which will likely include the child-caregiver dynamic, the child's mental and physical health, and social support mechanism.","other_id":"2009-P-001062","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":1,"maximum_age":10,"population":"young children receiving HIV antiretroviral therapy in a rural African setting","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  age 1 to 10 years\r\n\r\n          -  HIV-infected, meeting Ugandan criteria for antiretroviral therapy\r\n\r\n          -  living within 30 km of Mbarara, Uganda\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  lack of mobile-phone reception\r\n      ","sponsor":"Massachusetts General Hospital","sponsor_type":"Other","conditions":"HIV-infection/Aids","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Distribution of adherence","time_frame":"Monthly adherence levels will be determined over the six-month study period.","description":"Distribution of adherence based on wireless adherence monitoring devices and interactive voice response (IVR) or short message service (SMS) self report by caregivers of HIV-infected children under ten years old in Mbarara, Uganda."},{"outcome_type":"secondary","measure":"Feasibility and acceptability of wireless adherence measures","time_frame":"Assessments will be made a the one-month time point.","description":"Quantitive rating and qualitative description of the feasibility and acceptability of wireless adherence measures"},{"outcome_type":"secondary","measure":"Model of adherence behavior","time_frame":"Data collected at baseline and during adherence interruptions will be analyzed at the end of the six-month study period.","description":"Qualitative data will be used to explore a theoretical model of adherence behavior among young children in a rural African setting"}]}
{"nct_id":"NCT01110226","start_date":"2010-04-27","phase":"Phase 1","enrollment":23,"brief_title":"Trial Of Cisplatin And KML-001 in Platinum Responsive Malignancies","official_title":"Phase I Trial Of Cisplatin And KML-001 In Advanced Non-Small Cell Lung Cancer and Other Platinum Responsive Malignancies","primary_completion_date":"2015-10-22","study_type":"Interventional","rec_status":"Terminated","completion_date":"2015-10-27","last_update":"2020-03-17","description":"This is a Phase I Clinical Trial. Phase I studies are designed to determine the amount of investigational drugs that can be safely tolerated and to define the side effects that limit the dose. The drug administered in this study is KML-001. It is a highly soluble, orally available arsenic agent. It is currently being tested to determine its effects on telomerase activity. In other words, the purpose of this research study is to find the highest dose of KML001, that can be given without causing severe side effects when it is combined with a standard, commercially available anti-cancer drug called cisplatin.","other_id":"HP-00040420","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically or cytologically confirmed non-small cell lung cancer or other\r\n             \"platinum responsive malignancies\" , including but not limited to: esophageal cancer,\r\n             ovarian cancer, germ cell malignancies , transitional cell cancer etc. that are not\r\n             curable with chemotherapy, surgery or radiotherapy. A tissue block or fresh tissue\r\n             biopsy is required. Patients with CNS (Central Nervous System) metastases which are\r\n             symptomatic must have received therapy (surgery, X Ray Therapy (XRT), gamma knife) and\r\n             be neurologically stable and off steroids. Patients with asymptomatic lesions without\r\n             significant edema and no evidence of shift are allowed to participate without prior\r\n             CNS therapy. Such patients are anticipated to receive specific CNS therapy after 2-4\r\n             courses of therapy.\r\n\r\n          -  Patients may have received prior systemic chemotherapy or radiation therapy. At least\r\n             2 weeks should have elapsed since the last treatment and patients should have\r\n             recovered from previous significant toxicity (i.e. to grade 1 or less). Alopecia, skin\r\n             discoloration etc. are not considered significant toxicities. There is no limit on the\r\n             number of prior therapies. Patients may have received prior cisplatin or other\r\n             platinum regimens.\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2.\r\n\r\n          -  Patient 18 years of age or older.\r\n\r\n          -  Absolute Granulocyte Count greater than or equal to 1.5 x 10^9\r\n\r\n          -  Platelet count greater than or equal to 100 x 10^9\r\n\r\n          -  Serum creatinine within normal limits, or an estimated or measured creatinine\r\n             clearance greater than or equal to 65 ml/min.\r\n\r\n          -  All patients must be informed of the investigational nature of this study and must\r\n             sign and give written informed consent.\r\n\r\n          -  Serum calcium, magnesium and potassium must be within normal limits.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients must not have serious infection or other serious underlying medical condition\r\n             which would impair the ability of the patient to receive protocol treatment. These\r\n             need not be specified in the history and physical and can be documented through\r\n             signature on the eligibility checklist. Severe, active co-morbidity, defined as\r\n             follows:\r\n\r\n               1. Current uncontrolled cardiac disease;\r\n\r\n               2. Corrected (Bazett) QTc interval of > .50 ms (male) or > .52 ms (female);\r\n\r\n               3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time\r\n                  of registration;\r\n\r\n               4. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness\r\n                  requiring hospitalization or precluding study therapy within 4 weeks of\r\n                  registration;\r\n\r\n               5. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects;\r\n\r\n               6. Patients with acquired Immune Deficiency Syndrome (AIDS) based upon current\r\n                  Center for Disease Control (CDC) definition or patients known to be HIV positive.\r\n\r\n          -  Pregnancy or women of childbearing potential and men who are sexually active and not\r\n             willing/able to use medically acceptable forms of contraception.\r\n\r\n          -  Pre-existing  grade 2 peripheral neuropathy.\r\n      ","sponsor":"University of Maryland, Baltimore","sponsor_type":"Other","conditions":"Non-Small Cell Lung Cancer, Small Cell Lung Cancer|Platinum Responsive Malignancies","interventions":[{"intervention_type":"Drug","name":"Drug: KML-001","description":"KML001 will begin given to patients first. It should be taken by mouth immediately prior to cisplatin infusion. Patients will be treated in cohorts of three beginning at 15mg. The Dose will be increased until Maximum Tolerated Dose is established.\r\nKML001 will be administered daily for 14 days of a 21 day cycle. Patients will have one week off."},{"intervention_type":"Drug","name":"Drug: Cisplatin","description":"Cisplatin will be given to all patients at a dose of 75 mg/m2 on day 1 of every 21 day cycle over 30 to 90 minutes through an intravenous infusion immediately after the first dose of KML-001"}],"outcomes":[{"outcome_type":"primary","measure":"To determine the maximum tolerated dose of KML001 in combination with cisplatin","time_frame":"DLT to be determined up to 30 days after administration","description":"Once 3 subjects in a cohort reach a dose limiting toxicity. In this protocol, it took 23 months to determine the dose limiting toxicity."}]}
{"nct_id":"NCT02173171","start_date":"2010-04-27","enrollment":185,"brief_title":"Registry Study for Talimogene Laherparepvec","official_title":"A Registry Study to Evaluate the Survival and Long-Term Safety of Subjects Who Previously Received Talimogene Laherparepvec in Amgen or BioVEX-Sponsored Clinical Trials","primary_completion_date":"2021-09-23","study_type":"Observational [Patient Registry]","rec_status":"Active, not recruiting","completion_date":"2021-09-23","last_update":"2021-09-21","description":"A Registry Study to Evaluate the Survival and Long-Term Safety of Subjects Who Previously Received Talimogene Laherparepvec in Amgen or BioVEX-Sponsored Clinical Trials","other_id":"20120139","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":99,"population":"Subjects who have received at least one dose of talimogene laherparepvec in an Amgen or\r\n        BioVEX-sponsored clinical trial.","criteria":"\n        Inclusion Criteria:\r\n\r\n        All subjects must provide informed consent prior to initiation of any study activities.\r\n\r\n        All subjects must have received at least one dose of talimogene laherparepvec on an Amgen\r\n        or BioVEX-sponsored clinical trial for any tumor type and must have discontinued treatment\r\n        and participation, including long-term follow-up (if applicable) in that trial.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Subjects currently receiving talimogene laherparepvec in Amgen or BioVEX-sponsored clinical\r\n        trial.\r\n\r\n        Subject currently participating, including for long-term follow-up (if applicable), in\r\n        other Amgen-sponsored talimogene laherparepvec clinical trial.\r\n      ","sponsor":"Amgen","sponsor_type":"Industry","conditions":"Any Tumor Type Eligible for Treatment With Talimogene Laherparepvec in Amgen or BioVEX-sponsored Clinical Trial","interventions":[{"intervention_type":"Other","name":"Other: Information collection","description":"Q3M Information collection"}],"outcomes":[{"outcome_type":"primary","measure":"Talimogene Laherparepvec Related Adverse Events","time_frame":"7 years","description":"Long-term safety of talimogene laherparepvec will be assessed by reporting of related adverse events every 3 months. Related serious adverse events will be reported within 24 hours following investigator's knowledge of the event."},{"outcome_type":"primary","measure":"Subject overall survival","time_frame":"7 years","description":"Overall survival status will be reported every 3 months"},{"outcome_type":"primary","measure":"Use of subsequent anti-cancer therapy","time_frame":"7 years","description":"The use of subsequent anti-cancer therapy, for the tumor indication in the prior Amgen or BioVEX-sponsored clinical trial, including retreatment with marketed talimogene laherparepvec for approved indication in subjects previously enrolled in Amgen or BioVEX-sponsored talimogene laherparepvec clinical trials, will be monitored"}]}
{"nct_id":"NCT01241708","start_date":"2010-04-08","phase":"Phase 3","enrollment":146,"brief_title":"Tandem Auto Stem Cell Transplant With Melphalan Followed by Melphalan and Bortezomib in Patients With Multiple Myeloma","official_title":"Tandem Autologous Hematopoietic Stem Cell Transplant With Melphalan Followed by Melphalan and Bortezomib in Patients With Multiple Myeloma","primary_completion_date":"2022-09-30","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2022-09-30","last_update":"2021-08-26","description":"High dose chemotherapy with stem cell transplantation is commonplace in the treatment of multiple myeloma. This treatment uses a chemotherapy drug called Melphalan that has been used in several thousand bone marrow transplant recipients worldwide for the same or similar disorders.","other_id":"Pro00001295","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Changed from: Inclusion Criteria:\r\n\r\n          -  Confirmed diagnosis of multiple myeloma with either Durie-Salmon stage I, II, or III\r\n             or ISS stage I, II or III, less than 12 months since initiation of systemic therapy\r\n\r\n          -  8x106 CD34+cells/kg available in cryopreservation in aliquots appropriate for tandem\r\n             transplants\r\n\r\n          -  Age: 18-75 years at time of transplantation\r\n\r\n          -  KPS 70-100%\r\n\r\n          -  Recovery from complications of prior therapies\r\n\r\n          -  Gender: There is no gender restriction\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Diagnosis other than multiple myeloma\r\n\r\n          -  Chemotherapy or radiotherapy within 8 days of initiating treatment in this study\r\n\r\n          -  Prior autologous or allogeneic transplantation (except as enrolled into this study)\r\n\r\n          -  Uncontrolled bacterial, viral, fungal or parasitic infections\r\n      ","sponsor":"Hackensack Meridian Health","sponsor_type":"Other","conditions":"Multiple Myeloma|Auto Stem Cell Transplant","interventions":[{"intervention_type":"Drug","name":"Drug: Bortezomib","description":"Bortezomib 1.6mg/m2 on day -4 and day -1"}],"outcomes":[{"outcome_type":"primary","measure":"To determine the progression-free survival of patients with multiple myeloma treated with tandem cycles of high-dose melphalan followed by high-dose melphalan in combination with bortezomib with autologous HSC transplantation.","time_frame":"3 years"},{"outcome_type":"secondary","measure":"To determine the response rate, overall survival, and regimen-related toxicities of patients with multiple myeloma treated with high-dose melphalan or high-dose melphalan in combination with bortezomib given in tandem transplants.","time_frame":"lifetime"}]}
{"nct_id":"NCT01083420","start_date":"2010-03-31","phase":"Phase 3","enrollment":30,"brief_title":"The Efficacy of Topical Minocycline in Managing Symptomatic Oral Lichen Planus","official_title":"The Efficacy of Topical Minocycline in Managing Symptomatic Oral Lichen Planus. A Randomized Controlled Trial","primary_completion_date":"2011-03-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2012-03-31","last_update":"2010-03-09","description":"The aim of the present study is to assess the clinical efficacy of topical minocyclin in managing of symptoms associated with oral lichen planus (OLP). The rationale of the study is based on our previous studies demonstrating the beneficial effect of minocyclin mouthwash on recurrent aphthous stomatitis. The planned study will be a randomized controlled, cross-over trail. Patients with symptomatic OLP will randomly receive minocycline or dexamethasone rinses. The patients will rinse and expectorate 5 ml of the 1st mouthwash 4 times daily for 14 days. Subjects will complete a daily follow-up form that includes data regarding the daily intensity of pain (using VAS) caused by OLP and regarding possible side effects. After a washout period (at least 14 days) the patients will repeat the protocol with the second mouthwash.","other_id":"SHEBA-09-7335-NY-CTIL","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  OLP patients (Biopsy proven)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Known allergy to Dexamethasone or Minocycline\r\n\r\n          -  Pregnancy\r\n      ","sponsor":"Sheba Medical Center","sponsor_type":"Other","conditions":"Oral Lichen Planus","interventions":[{"intervention_type":"Drug","name":"Drug: Minocycline","description":"Minocycline 0.2% mouthwash"},{"intervention_type":"Drug","name":"Drug: Dexamethasone","description":"Dexamethasone 0.01% mouthwash"}],"outcomes":[{"outcome_type":"primary","measure":"symptoms relief","time_frame":"2 years"}]}
{"nct_id":"NCT01359722","start_date":"2010-03-31","phase":"N/A","enrollment":50,"brief_title":"N-acetylcysteine to Prevent Renal Failure","official_title":"N-acetylcysteine to Prevent Renal Failure in Patients With Chronic Kidney Disease Undergoing Coronary Artery Bypass Surgery","primary_completion_date":"2011-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2012-12-31","last_update":"2011-05-25","description":"The purpose of this study is to determine the possible effect nephroprotective of N-acetylcysteine in patients with chronic kidney disease undergoing elective coronary artery bypass grafting by serial evaluation of renal function and to evaluate whether treatment reduces cardiac mortality, cardiac events and Global mortality, if it interferes with oxidative stress and inflammation and the need for dialysis.","other_id":"0992/09","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":30,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  adult patients aged 30 to 80 years old of both sexes\r\n\r\n          -  indicated for elective CABG\r\n\r\n          -  with glomerular filtration rate, assessed with the MDRD <60 mL/min/1, 73 m2 and> 15 mL\r\n             / min / 1.73 m2 body surface\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  patients on chronic dialysis or with creatinine> 5 mg / dL preoperatively; individuals\r\n             allergic or intolerant to N-acetylcysteine\r\n\r\n          -  pregnant women\r\n\r\n          -  patients with cancer\r\n\r\n          -  patients underwent re-surgery within the first 72 hours postoperatively\r\n      ","sponsor":"Instituto do Coracao","sponsor_type":"Other","conditions":"Kidney Failure, Acute|Oxidative Stress Induction","interventions":[{"intervention_type":"Drug","name":"Drug: N-acetylcysteine","description":"N-acetylcysteine is administered at a dose of 150mg/kg in 500mL of saline EV in 1 hour followed by a dose of 50mg/kg in 500 mL of saline IV within 6 hours, beginning the infusion together to surgery."},{"intervention_type":"Drug","name":"Drug: Control","description":"The control group will receive only the infusion of saline in the same doses and infusion rate."}],"outcomes":[{"outcome_type":"primary","measure":"Decrease in glomerular filtration defined by at least 30% compared to preoperative levels .","time_frame":"Within the first 72 hours postoperatively"},{"outcome_type":"secondary","measure":"Up 50% of preoperative levels of serum creatinine.","time_frame":"Within the first 72 hours after surgery and cardiovascular morbidity and all-cause mortality at thirty days post-operatively."},{"outcome_type":"secondary","measure":"Death from any cause.","time_frame":"Within the first 72 hours after surgery and cardiovascular morbidity and all-cause mortality at thirty days post-operatively."},{"outcome_type":"secondary","measure":"Need for dialysis","time_frame":"Within the first 72 hours after surgery and cardiovascular morbidity and all-cause mortality at thirty days post-operatively."},{"outcome_type":"secondary","measure":"Cardiovascular morbidity.","time_frame":"Within the first 72 hours after surgery and cardiovascular morbidity and all-cause mortality at thirty days post-operatively."},{"outcome_type":"secondary","measure":"Increased levels of Cystatin C.","time_frame":"Within the first 72 hours after surgery and cardiovascular morbidity and all-cause mortality at thirty days post-operatively."},{"outcome_type":"secondary","measure":"Increased levels of NGAL.","time_frame":"Within the first 72 hours after surgery and cardiovascular morbidity and all-cause mortality at thirty days post-operatively."},{"outcome_type":"secondary","measure":"Increased levels of isoprostane.","time_frame":"Within the first 72 hours after surgery and cardiovascular morbidity and all-cause mortality at thirty days post-operatively."}]}
{"nct_id":"NCT02442167","start_date":"2010-03-31","enrollment":101,"brief_title":"Performance of FISH for the Diagnosis of Malignant Biliary Strictures in Thai Patients","official_title":"Fluorescence in Situ Hybridization (FISH) Improves Performance of Conventional Cytology for the Diagnosis of Malignant Biliary Tract Strictures in Thai Patients","primary_completion_date":"2013-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2014-12-31","last_update":"2015-05-13","description":"Fluorescence in situ hybridization (FISH) has improved the diagnostic performance of cytology for evaluation of malignant biliary strictures in the US and Europe. The utility of FISH for diagnosis of biliary strictures in Asia is currently unknown. The investigators conducted a prospective study in 2 university hospitals to determine diagnostic performance of FISH for the diagnosis of malignant biliary strictures in Thai patients.","other_id":"14-008579","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients being evaluated for malignant appearing biliary tract strictures who undergo ERCP","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age > 18 years\r\n\r\n          -  Clinical suspicion of malignant biliary tract strictures\r\n      ","sponsor":"Mayo Clinic","sponsor_type":"Other","conditions":"Bile Duct Stricture|Malignancy","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Sensitivities with 95% confidence intervals of FISH","time_frame":"Up to 12 months","description":"Sensitivities with 95% confidence intervals of FISH and routine cytology will be compared"}]}
{"nct_id":"NCT01228175","start_date":"2010-03-31","phase":"Phase 4","enrollment":218,"brief_title":"Effectiveness of Varenicline: Testing Individual Differences","official_title":"Effectiveness of Varenicline: Testing Individual Differences","primary_completion_date":"2015-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-03-31","last_update":"2018-05-09","description":"The study will evaluate the effectiveness of smoking cessation using Varenicline versus placebo. Effectiveness will be measured by the average number of cigarettes smoked per smoking day for up to 36 weeks.","other_id":"R01DA025074","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18 yrs to 55 yrs\r\n\r\n          -  smoker\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Medical Contraindications\r\n      ","sponsor":"The Mind Research Network","sponsor_type":"Other","conditions":"Smoking Addiction","interventions":[{"intervention_type":"Drug","name":"Drug: Placebo","description":"25mg look alike riboflavin tablets to match active study medication."},{"intervention_type":"Drug","name":"Drug: Varenicline","description":"Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily"}],"outcomes":[{"outcome_type":"primary","measure":"Cigarettes Per Smoking Day","time_frame":"up to 36 weeks","description":"The number of cigarettes smoked were assessed only on a \"smoking day\", i.e., when a participant smoked at least 1 cigarette. Data was recorded each day for up to 36 weeks."}]}
{"nct_id":"NCT00988039","start_date":"2010-03-31","phase":"Phase 3","enrollment":1277,"brief_title":"Europe-Africa Research Network for Evaluation of Second-line Therapy","official_title":"A Randomised Controlled Trial to Evaluate Options for Second-line Therapy in Patients Failing a First-line 2NRTI + NNRTI Regimen in Africa","primary_completion_date":"2014-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-01-31","last_update":"2014-04-04","description":"The trial aim is to ascertain what, if anything, needs to be combined with a boosted protease inhibitor (bPI) backbone in second-line therapy in order to maximize the chance of a good clinical outcome following WHO-defined failure on a first-line nucleoside reverse transcriptase inhibitor (NRTI) and NNRTI-containing regimen with probable extensive NRTI and NNRTI resistance mutations.","other_id":"U.1228.03.004.00021.01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":12,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Previously documented HIV infection on at least one standard antibody-based test\r\n\r\n          -  Age 12 years and above\r\n\r\n          -  Taking 2NRTI + NNRTI-based regimen continuously for at least 12 months\r\n\r\n          -  Naive to protease inhibitor therapy\r\n\r\n          -  Good adherence to ART in the 12 weeks prior to screening defined as missing medication\r\n             on no more than 3 days in the prior month\r\n\r\n          -  Clinically stable and receiving treatment for any known opportunistic infections\r\n\r\n          -  HIV treatment failure defined by one or more of clinical, immunological or virological\r\n             criteria defined in the protocol, including VL and CD4 at screening visit\r\n\r\n          -  Willing and able to give informed consent\r\n\r\n          -  Able to attend for regular study follow up visits\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any major clinical contra-indications to the use of bPI, the NRTIs that are available\r\n             to be selected for a second-line regimen or raltegravir\r\n\r\n          -  Known Hepatitis B carrier (Hepatitis B surface antigen positive if tested)\r\n\r\n          -  Requires concomitant medication with known major interactions with study drugs for\r\n             which drug substitutions or dose alterations are not available or acceptable\r\n\r\n          -  Women who are currently pregnant or breastfeeding\r\n\r\n          -  Current participation in another clinical trial involving a treatment intervention\r\n             (may be permitted in some circumstances, but must be discussed with MRC CTU)\r\n\r\n          -  Life expectancy of less than one month in the opinion of the treating physician\r\n      ","sponsor":"Justine Boles","sponsor_type":"Other","conditions":"Human Immunodeficiency Virus|HIV","interventions":[{"intervention_type":"Drug","name":"Drug: Aluvia + 2NRTIs","description":"Aluvia (lopinavir/ritonavir 400mg/100mg), twice daily\r\nThe choice of NRTIs will be at the discretion of the managing clinician and based on the local standard of care and drug availability, taking into account patient's previous drug exposure and side effects on first-line therapy."},{"intervention_type":"Drug","name":"Drug: Aluvia + raltegravir","description":"Aluvia (lopinavir/ritonavir 400mg/100mg) twice daily\r\nraltegravir (400mg) twice daily"},{"intervention_type":"Drug","name":"Drug: Aluvia monotherapy","description":"Aluvia (lopinavir/ritonavir 400mg/100mg) twice daily\r\nraltegravir (400mg) twice daily for the first 12 weeks only"}],"outcomes":[{"outcome_type":"secondary","measure":"Good HIV disease control","time_frame":"week 144"},{"outcome_type":"secondary","measure":"Proportion with CD4 cell count >250 cells/mm3","time_frame":"week 96 and week 144"},{"outcome_type":"secondary","measure":"Proportion with new or recurrent WHO stage 4 event","time_frame":"week 96 and week 144"},{"outcome_type":"primary","measure":"Good HIV disease control defined as a composite endpoint consisting of all of: - No new WHO stage 4 events - CD4 count >250 cells/mm3 - viral load <10,000 copies/ml or >10,000 copies/ml with no PI resistance mutations","time_frame":"week 96"},{"outcome_type":"secondary","measure":"Proportion of patients with plasma viral load <50 copies","time_frame":"week 48, week 96 and week 144"},{"outcome_type":"secondary","measure":"Adverse events","time_frame":"During trial"},{"outcome_type":"secondary","measure":"Quality of life change from randomisation","time_frame":"During trial"},{"outcome_type":"secondary","measure":"Neurocognitive function change from randomisation","time_frame":"during trial"},{"outcome_type":"secondary","measure":"Healthcare costs","time_frame":"During trial"},{"outcome_type":"secondary","measure":"Proportion with serious non-AIDS events","time_frame":"Week 96 and week 144"}]}
{"nct_id":"NCT01080274","start_date":"2010-03-31","enrollment":200,"brief_title":"Vitamin D and Zinc Levels in Patients Undergoing Ergometry Test","official_title":"Vitamin D and Zinc Levels in Patients Undergoing Ergometry Test","primary_completion_date":"2011-03-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2011-03-31","last_update":"2010-04-07","description":"Low vitamin D levels were found to be associated with cardiovascular morbidity and mortality. Low zinc levels are associated with an increased atherosclerotic burden. Therefore we hypothesized that patients with pathological stress test would have low levels of Vitamin D and zinc compared to patients with a normal stress test.","other_id":"22/10","observational_model":"Case-Control","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"-  Over 18 years old\r\n\r\n          -  CCT > 60 ml/min\r\n\r\n          -  No IHD\r\n\r\n          -  No hyper/hypoparathyroidism\r\n\r\n          -  No active malignancy\r\n\r\n          -  Not taking calcium, phosphate","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Over 18 years old\r\n\r\n          -  CCT > 60 ml/min\r\n\r\n          -  No IHD\r\n\r\n          -  No hyper/hypoparathyroidism\r\n\r\n          -  No active malignancy\r\n\r\n          -  Not taking calcium, phosphate\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Under 18 years of age\r\n\r\n          -  Not fulfilling inclusion criteria\r\n      ","sponsor":"Assaf-Harofeh Medical Center","sponsor_type":"Other","conditions":"Atherosclerosis","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"positive stress test","time_frame":"one year"}]}
{"nct_id":"NCT01099618","start_date":"2010-03-31","phase":"Phase 4","enrollment":48,"brief_title":"Ketosis-Prone Diabetes Mellitus (KPDM): Metformin Versus Sitagliptin Treatment","official_title":"Ketosis-Prone Diabetes in African Americans: Predictive Markers, Underlying Mechanisms, and Treatment Outcomes: The Effects of Metformin vs. Sitagliptin on Beta-Cell Preservation in Obese Subjects With Ketosis-Prone Type 2 Diabetes Mellitus","primary_completion_date":"2014-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-08-31","last_update":"2015-06-18","description":"The study intends on enrolling 48 subjects with diabetes. Diabetic subjects that no longer need insulin will be randomly placed (like the flip of a coin) on a diabetes pill called metformin, a diabetes pill called sitagliptin or a placebo pill (a pill without active medication). Subjects on pills will be followed for 3 years and undergo blood tests at specified intervals to assess their ability to make insulin. These studies will allow a better understanding of the factors that lead to high blood sugar in patients with ketosis-prone diabetes mellitus (KPDM) and direct the best diabetes treatment for this patient population. Hypothesis: Metformin therapy or sitagliptin therapy compared to placebo, will improve -cell function, insulin sensitivity, and allow for a longer period of time prior to encountering an insulin-deficient relapse after discontinuation of insulin therapy.","other_id":"IRB00026272","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":19,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. All newly diagnosed overweight/obese (BMI >/=28 kg/m2) African-American patients with\r\n             new-onset DKA and/or severe hyperglycemia and without apparent precipitating cause\r\n             will be considered for inclusion into the study. The diagnosis of DKA will be\r\n             established by standard criteria (blood glucose > 250 mg/dL, pH < 7.3, HCO3 < 18\r\n             mmol/L, increased anion gap).\r\n\r\n          2. The hyperglycemic group will include patients with an admission plasma glucose > 400\r\n             mg/dL but without the presence of metabolic acidosis or ketosis.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. significant medical or surgical illness, including but not limited to myocardial\r\n             ischemia, congestive heart failure, chronic renal insufficiency, liver failure, and\r\n             infectious processes;\r\n\r\n          2. recognized or suspected endocrine disorders associated with increased insulin\r\n             resistance, such as hypercortisolism, acromegaly, or hyperthyroidism;\r\n\r\n          3. bleeding disorders, thrombocytopenia, or abnormalities in coagulation studies;\r\n\r\n          4. pregnancy,\r\n\r\n          5. have an allergy to any component of metformin or sitagliptin.\r\n      ","sponsor":"Dawn Smiley MD","sponsor_type":"Other","conditions":"Ketosis Prone Diabetes|Diabetes Ketoacidosis|Hyperglycemia","interventions":[{"intervention_type":"Drug","name":"Drug: metformin","description":"The study subject will receive metformin (MET) 1000 mg tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."},{"intervention_type":"Drug","name":"Drug: placebo","description":"The study subject will receive a placebo tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."},{"intervention_type":"Drug","name":"Drug: Sitagliptin","description":"The study subject will receive a sitagliptin 100mg once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."}],"outcomes":[{"outcome_type":"primary","measure":"Length of Remission","time_frame":"3 years","description":"For those patients that are able to discontinue insulin therapy at or <12 weeks, how long were they able to well controlled with an A1c <7% on the agent that they were randomized to."}]}
{"nct_id":"NCT01016678","start_date":"2010-03-31","phase":"Phase 2/Phase 3","enrollment":104,"brief_title":"Treximet Early Intervention Adolescent Migraine","official_title":"Early Intervention, Randomized, Mulitcenter, Placebo-Controlled, 4-Period Crossover, Multi-Attack Study to Evaluate Efficacy & Safety of ComboProduct Containing Sumatriptan and Naproxen Sodium for Acute Treatment of Migraine in Adolescents","primary_completion_date":"2014-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-07-31","last_update":"2016-05-04","description":"The study involves approximately 105 adolescent (ages 12-17) subjects to be screened at 4 sites across the US. All subjects enrolled will treat up to 4 MILD migraines over a 6 month period. They will be required to have three office visits during the six months. All subjects will be randomized to either Treximet (85mg Imitrex/500mg Naproxen Sodium) or Placebo (sugar-pill) in four of the five treatment arms with a 3 to 1 ratio. A fifth treatment arm will treat all 4 migraines with active drug, Treximet. The hypothesis is that Treximet will prove to be a safe and effective treatment for this population, that has so few treatment for migraine. And Treximet will be superior over placebo for pain free endpoints at 2 and 24 hours.","other_id":"TEAM2009","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":12,"maximum_age":17,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Male or female subjects between the ages of 12-17.\r\n\r\n          2. Subject has migraine with or without aura (ICHD-II criteria, 1.2.1 or 1.1). A history\r\n             of at least 1 but no more than 8 attacks per month on average over the past 6 months\r\n             prior to screening visit. Attacks should be moderate to severe and last for at least 3\r\n             hours.\r\n\r\n          3. Subject is able to distinguish migraine from other headaches and can determine when a\r\n             mild headache will become a moderate/severe migraine.\r\n\r\n          4. Female subjects are eligible for participation provided they are of non-child bearing\r\n             potential or if started menses; they are on a stable regimen of approved\r\n             contraception.\r\n\r\n          5. Subject and subject's parent or legal guardian are able to read and write English.\r\n\r\n          6. Subject is able to read, comprehend, and complete subject diaries.\r\n\r\n          7. Subjects' parent or legal guardian is willing and able to provide Informed Consent\r\n             prior to subject entry into the study.\r\n\r\n          8. Subject is willing and able to provide Informed Assent prior to entry into the study.\r\n\r\n        Exclusion Criteria\r\n\r\n        Subjects meeting any of the following criteria must not be enrolled in the study:\r\n\r\n          1. Subject is < 74 pounds (33.3kg) and no greater than 260lbs (117.9kg)\r\n\r\n          2. Subject has greater than or equal to 15 headache days per month in total.\r\n\r\n          3. Subject has secondary headaches i.e. complex migraine, hemiplegic, or basilar.\r\n\r\n          4. Subject, in investigators opinion is likely to have unrecognized cardiovascular or\r\n             cerebrovascular disease.\r\n\r\n          5. Subject has uncontrolled hypertension at screening or is taking an\r\n             angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker.\r\n\r\n          6. Subject has a history of congenital heart disease, cardiac arrhythmias requiring\r\n             medication, or a history of a clinically significant electrocardiogram abnormality\r\n             that, in the investigator's opinion, contraindicates participation in the study.\r\n\r\n          7. Subject has evidence or history of any ischemic vascular diseases including: ischemic\r\n             heart disease, ischemic abdominal syndromes, peripheral vascular disease, or\r\n             signs/symptoms consistent with the above.\r\n\r\n          8. Subject has a evidence or history of central nervous system pathology including stroke\r\n             and/or transient ischemic attacks (TIAs), epilepsy or structural brain lesions which\r\n             lower the convulsive threshold, or has been treated with an anti-epileptic drug for\r\n             seizure control within 5 years prior to screening.\r\n\r\n          9. Subject has a history of impaired hepatic or renal function that, in the\r\n             investigator's opinion, contraindicates participation in this study.\r\n\r\n         10. Subject has a hypersensitivity, allergy, intolerance, or contraindication to the use\r\n             any triptan, NSAID, or aspirin (including all sumatriptan and naproxen preparations)\r\n             or has nasal polyps or asthma.\r\n\r\n         11. Subject has used an ergot medication in the previous three months for migraine\r\n             prophylaxis or is taking a medication that is not stabilized for at least two months\r\n             for either chronic or intermittent migraine prophylaxis or other co-morbid condition.\r\n\r\n         12. Subject has taken or plans to take a monoamine oxidase inhibitor (MAOI) including\r\n             herbal preparations containing St. Johns Wort (Hypericum perforatum), anytime within\r\n             the two weeks prior to screening and two weeks past exit of study.\r\n\r\n         13. Subject has a history of any bleeding disorder or is currently taking any\r\n             anti-coagulant or any antiplatelet agent.\r\n\r\n         14. Subject has evidence or history of any gastrointestinal surgery, GI ulceration, or\r\n             perforation in the past six months, gastrointestinal bleeding in the past year, or\r\n             evidence or history of inflammatory bowel disease.\r\n\r\n         15. Subject is pregnant, actively trying to become pregnant, or breast feeding or Subject\r\n             is not willing to have pregnancy test(s).\r\n\r\n         16. Subject has evidence of illicit drug or alcohol abuse within the last year or any\r\n             concurrent psychiatric condition which, in the investigator's opinion, will likely\r\n             interfere with study conduct and participation in the trial.\r\n\r\n         17. Subject has participated in any investigational drug trial within the previous 4 weeks\r\n             or plans to participate in another study at any time during this study.\r\n      ","sponsor":"Premiere Research Institute","sponsor_type":"Other","conditions":"Migraine","interventions":[{"intervention_type":"Drug","name":"Drug: Treximet","description":"85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Dummy pill comparator"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants With 2-hour Pain Free Active Study Drug","time_frame":"3 years","description":"All data was collected and measured from self-reported patient diaries"},{"outcome_type":"primary","measure":"Percentage of Migraine Attacks With Sustained Pain Free Response From 2 to 24 Hours Post-Dose","time_frame":"3 years","description":"All data was collected and measured from self-reported patient diaries"},{"outcome_type":"primary","measure":"Percentage of Migraine Attacks With Pain Free Response at 2 Hours Post-Dose Following Early Intervention","time_frame":"3 years","description":"All data was collected and measured from self-reported patient diaries"},{"outcome_type":"secondary","measure":"To Evaluate the Consistency of Response Across Four Migraine Attacks at 1, 2, 4, and 24 Hours After Treatment. Frequency of Rescue Medications Needed and the Consistency of Other Symptom Relief i.e. Nausea, Vomiting, Photophobia, and Phonophobia.","time_frame":"3 years","description":"Collected from patient reported paper diaries"}]}
{"nct_id":"NCT01218503","start_date":"2010-03-31","phase":"N/A","enrollment":90,"brief_title":"The Neural Correlates of Food Choice Decision-making in Obesity and Weight Loss","official_title":"The Neural Correlates of Food Choice Decision-making in Obesity and Weight Loss (CHOICES)","primary_completion_date":"2016-10-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2016-10-31","last_update":"2013-07-29","description":"This study is designed to determine whether obese, normal weight, and successful weight loss maintainers differ in their food choice decision-making and/or executive function, and whether participation in a behavioral weight loss program leads to neural and/or behavioral changes. The investigators will examine behavioral performance on several tasks involving decision-making and self-control in conjunction with brain imaging data acquired during a food-choice decision-making task. Participants enrolled in the behavioral weight loss program will also be assessed following the treatment.","other_id":"BRAIN-T32","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":35,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  women, ages 35-55, who are either currently obese (BMI = 30-40 kg/m2), always normal\r\n             weight (lifetime BMI < 25, NW) or successful weight loss maintainers who have lost 10%\r\n             of their body weight and maintained that loss for at least 1 year (lifetime maximum\r\n             BMI = 30-40 kg/m2)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  weight loss medications, binge eating, standard MRI contraindications (e.g., metal\r\n             implants, claustrophobia, pregnancy), left-handedness, food allergies, neurological or\r\n             psychiatric conditions, including but not limited to schizophrenia, bipolar disorder,\r\n             epilepsy, stroke and traumatic brain injury with loss of consciousness, and, among\r\n             obese participants, inability to participate at two time points and lack of interest\r\n             in participating in a behavioral weight loss trial\r\n\r\n          -  serious current physical disease (e.g., heart disease and cancer) for which physician\r\n             supervision of diet and exercise prescription is needed, physical problems that limit\r\n             the ability to exercise, participation in a weight loss program in the last 2 months\r\n             and intention to become pregnant in the next 6 months\r\n      ","sponsor":"The Miriam Hospital","sponsor_type":"Other","conditions":"Obesity|Weight Loss|Weight Control","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: CHOICES - obese","description":"Standard group behavioral weight loss treatment"}],"outcomes":[{"outcome_type":"primary","measure":"fMRI","time_frame":"pre- and post-treatment in obese group, single time point for SWLM and NW"},{"outcome_type":"secondary","measure":"Behavioral data","time_frame":"pre- and post-treatment of obese group, single time point for SWLM and NW"}]}
{"nct_id":"NCT01116869","start_date":"2010-03-25","enrollment":500,"brief_title":"China CellSearch Study","official_title":"A Multi-Center, Prospective Study to Evaluate the Ability of CTC Enumeration Using the CellSearch Circulating Tumor Cell Kit to Predict Prognosis and to Assess the Agreement Between CTC and Imaging Determined Response in MBC Patients CellSearch  ","primary_completion_date":"2011-06-22","study_type":"Observational","rec_status":"Completed","completion_date":"2014-01-06","last_update":"2019-11-15","description":"The study is designed to confirm the current indication (below) of the CellSearch Circulating Tumor Cell Kit in metastatic breast cancer (MBC) patients for use of the kit in China. The CellSearch Circulating Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole blood. The presence of CTC in the peripheral blood, as detected by the CellSearch Circulating Tumor Cell Kit, is associated with decreased progression free survival and decreased overall survival in patients treated for metastatic breast cancer. This test is to be used as an aid in the monitoring of patients with metastatic breast cancer. Serial testing for CTC should be used in conjunction with other clinical methods for monitoring metastatic breast cancer. Evaluation of CTC at any time during the course of disease allows assessment of patient prognosis and is predictive of progression free survival and overall survival.","other_id":"200901","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"Female","minimum_age":18,"maximum_age":70,"population":"The hazard ratio of disease progression in patients with unfavorable versus favorable CTC\r\n        counts at baseline, 3-4 weeks and 6-8 weeks after the initiation of therapy will be\r\n        estimated using Cox regression.\r\n\r\n        Kaplan-Meier plots for PFS will be constructed using the favorable and unfavorable CTC\r\n        patient groups. The log-rank test will be used to determine if the curves for the two CTC\r\n        groups are statistically significantly different.\r\n\r\n        The hazard ratio of death in patients with unfavorable versus favorable CTC counts at each\r\n        blood draw time point will be estimated using Cox regression. Kaplan-Meier plots for OS\r\n        will be constructed using the favorable and unfavorable CTC patient groups.","criteria":"\n        Inclusion Criteria\r\n\r\n          -  Female\r\n\r\n          -  over 18 and less than 70 years of age\r\n\r\n          -  Subject having agreed to participate in the study and follow the study procedures by\r\n             providing written informed consent prior entering the study.\r\n\r\n          -  For MBC Subject Set only Confirmed metastatic breast cancer patient with at least one\r\n             measurable solid tumor according to the RECIST guideline Starting a new line of\r\n             systemic therapy which is recommended in the Chinese edition of NCCN Clinical Practice\r\n             Guidelines in Oncology Breast Cancer Guideline 2009 line of chemotherapy should be\r\n             over 3 ECOG performance grade of 0 to 2 Life expectancy over 3 months\r\n\r\n          -  For Healthy Subject Set only Medical examinations detect no breast benign and\r\n             malignant tumors\r\n\r\n          -  For Benign Breast Disease Subject Set only Pathology diagnosed breast benign tumor\r\n             disease\r\n\r\n        Exclusion Criteria\r\n\r\n          -  Self reported pregnancy\r\n\r\n          -  For MBC Subject Set only Prior history of other malignancy Patients who have surgery\r\n             to remove any metastatic lesions or receive radiation therapy during her participation\r\n             in the study\r\n\r\n          -  For Healthy Subject Set only Prior history of breast benign tumor disease or any\r\n             malignancy Any conditions inappropriate for blood drawing\r\n\r\n          -  For Benign Breast Disease Subject Set only Prior history of any malignancy Any\r\n             conditions inappropriate for blood drawing\r\n      ","sponsor":"Johnson & Johnson Medical, China","sponsor_type":"Industry","conditions":"Metastatic Breast Cancer|Benign Breast Disease","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Ability of CTC levels to predict progression-free survival (PFS) in MBC patients.","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Ability of CTC levels to predict overall survival (OS) in MBC patients.","time_frame":"3 years"},{"outcome_type":"secondary","measure":"Agreement between CTC counts (3-4 weeks and 6-8 weeks) after the initiation of a new line of systemic therapy and the patient's response as determined by imaging evaluation (6-8 weeks after the initiation of therapy) in MBC patients.","time_frame":"12 months"}]}
{"nct_id":"NCT01093729","start_date":"2010-02-28","phase":"Phase 1","enrollment":41,"brief_title":"A Study of HM11260C in Healthy Male Subject","official_title":"A Dose Block-randomized, Double-blind, Single Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of HM11260C After Subcutaneous Administration in Healthy Male Subjects","primary_completion_date":"2010-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-10-31","last_update":"2014-02-07","description":"Study Design: Randomized, double-blind, placebo-controlled, escalating single-dose design. Five ascending dose cohorts are planned.","other_id":"HM-EXC-101","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"Male","minimum_age":20,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Healthy male volunteers, age range 20 to 45 years\r\n\r\n          2. Weight>50 and < 90kg, Body mass index of >18 and <27 Subject is informed of the\r\n             investigational nature of this study and voluntarily agrees to participate in this\r\n             study\r\n\r\n        Exclusion Criteria\r\n\r\n          1. Acute disease within 1 month prior to start of study drug administration\r\n\r\n          2. Has previously disease which affect drug absorption, distribution, metabolism,\r\n             excretion (e.g., inflammatory gastric disease, gastric or intestinal ulcer, hepatic\r\n             disease, renal disease)\r\n\r\n          3. History or presence of clinically significant and active cardiovascular, pulmonary,\r\n             renal, endocrine, hematological, gastrointestinal, central nervous system, psychiatric\r\n             disorder, autoimmune disease, or malignant tumor\r\n\r\n          4. Has unsuitable clinical test results through the medical checkup, within 35 days prior\r\n             to start of administration of study drug (medical history, physical examination, ECG,\r\n             laboratory test)\r\n\r\n          5. Laboratory test results\r\n\r\n               1. AST (sGOT) or ALT (sGPT) > 1.25Xupper normal limit\r\n\r\n               2. Total bilirubin > 1.5Xupper normal limit\r\n\r\n               3. Absolute Neutrophil Count < 1500 mm2\r\n\r\n          6. History or presence of clinically significant allergic disease (including mild\r\n             allergic rhinitis and allergic dermatitis which is not necessary to medication)\r\n\r\n          7. Prior exposure to products related to Exenatide\r\n\r\n          8. Use of any prescription medication within 14 days prior to Day 1\r\n\r\n          9. Use of any medication within 7 days prior to Day 1 (over-the-counter medication,\r\n             herbal products, nutrient, vitamins)\r\n\r\n         10. Subject who can't eat standard meal received by Korea University Anam Hospital\r\n\r\n         11. Donor of whole blood for transfusion within 60 days prior to start of study drug\r\n             administration or donor of apheresis within 20 days or Receiver of blood transfusion\r\n             within 1 month\r\n\r\n         12. Participation in another clinical study within 60 days prior to start of study drug\r\n             administration\r\n\r\n         13. Taking Caffein(> 5cups/ day) or alcohol abuse (> 30g/ day) or excessive smoker(> 10\r\n             Subject is informed of the investigational nature of this study and voluntarily agrees\r\n             to participate in this study\r\n      ","sponsor":"Hanmi Pharmaceutical Company Limited","sponsor_type":"Industry","conditions":"Healthy","interventions":[{"intervention_type":"Drug","name":"Drug: HM11260C","description":"HM11260C 0.5mcg/kg or Placebo"},{"intervention_type":"Drug","name":"Drug: HM11260C","description":"HM11260C 2mcg/kg or Placebo"},{"intervention_type":"Drug","name":"Drug: HM11260C","description":"HM11260C 4mcg/kg or Placebo"},{"intervention_type":"Drug","name":"Drug: HM11260C","description":"HM11260C 8mcg/kg or Placebo"},{"intervention_type":"Drug","name":"Drug: HM11260C","description":"HM11260C 14mcg/kg or Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"Safety","time_frame":"1, 2, 3, 4, 5, 7, 9, 16, 22, 30, 36, 43, 57, 84 Day","description":"Investigate Safety of HM10560A: Safety data, including physical examinations, laboratory evaluation, ECGs, vital signs, adverse events, and immunogenicity"}]}
{"nct_id":"NCT01133795","start_date":"2010-02-28","phase":"Phase 2","enrollment":7,"brief_title":"Midodrine and Albumin for Cirrhotic Patients With Functional Renal Impairment","official_title":"Effect of Administration of Intravenous Albumin and Oral Midodrine on Renal Function in Patients With Cirrhosis and Functional Renal Impairment","primary_completion_date":"2016-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-06-30","last_update":"2016-08-18","description":"The objective of the study was evaluate the effect of administration of midodrine and albumin on renal function in patients with cirrhosis and creatinine greater than 1,2mg/dl.","other_id":"MAFRI","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Liver Cirrhosis\r\n\r\n          -  Serum Creatinine greater than 1,2 mg/dL\r\n\r\n          -  to have given written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  pregnancy\r\n\r\n          -  Systolic blood pressure above 150mmHg and/or diastolic blood pressure above 90mmHg\r\n\r\n          -  Previous treatment with transjugular intrahepatic portosystemic shunt (TIPS) or\r\n             surgical shunts\r\n\r\n          -  Antibiotic treatment in the previous 7 days before inclusion, except for prophylaxis\r\n             of spontaneous bacterial peritonitis\r\n\r\n          -  infection by HIV\r\n\r\n          -  contraindications for albumin and/or midodrine use\r\n      ","sponsor":"Hospital Clinic of Barcelona","sponsor_type":"Other","conditions":"Cirrhosis|Renal Failure","interventions":[{"intervention_type":"Drug","name":"Drug: Midodrine plus Albumin","description":"MIdodrine 10mg tid for 12 weeks. Albumin 40g every 14 days for 12 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Changes in glomerular filtration rate assessed by isotopic methods","time_frame":"at 12 weeks of treatment"},{"outcome_type":"secondary","measure":"changes in arterial pressure as assessed by continuous ambulatory arterial pressure","time_frame":"at 12 weeks of treatment"},{"outcome_type":"secondary","measure":"changes in plasma renin activity","time_frame":"at 12 weeks of treatment"},{"outcome_type":"secondary","measure":"changes in aldosterone concentration","time_frame":"at 12 weeks of treatment"},{"outcome_type":"secondary","measure":"changes in norepinephrine concentration","time_frame":"at 12 weeks of treatment"}]}
{"nct_id":"NCT01320891","start_date":"2010-02-28","phase":"N/A","enrollment":40,"brief_title":"Effects of Different Strategy of Fluids Administration on Acid/Base Disorders and Inflammatory Mediators","official_title":"Effects of Different Strategy of Fluids Administration on Acid/Base Disorders and Inflammatory Mediators","primary_completion_date":"2011-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-02-29","last_update":"2017-05-08","description":"Aim of the study is to ascertain whether a different strategy of fluids administration can be responsible of differences in terms of acid/base disorders (Stewart approach), pro-inflammatory and inflammatory mediators. Hence two groups of patients will be treated either with not-balanced solutions (Normal Saline) or balanced solutions","other_id":"HC-I-H-0909","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":90,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with diagnosis of large bowel cancer\r\n\r\n          -  Age > 18 years old\r\n\r\n        Exclusion Criteria:\r\n\r\n        Emergency surgery for bowel punch or intestinal occlusion\r\n\r\n          -  Massive bleeding\r\n\r\n          -  Therapy with corticosteroid or nonsteroid antiinflammatory substances\r\n\r\n          -  Renal insufficiency (serum creatinine > 200 micromol /l)\r\n\r\n          -  Cardiac insufficiency (NYHA III-IV)\r\n\r\n          -  Altered liver function (ALT > 40 U/l AST >40 U/l)\r\n\r\n          -  Preoperative anaemia ( Hb < 10 g/dl )\r\n\r\n          -  Allergy to hydrossietilic starches\r\n\r\n          -  Patient rejection to share the study\r\n      ","sponsor":"Universit degli Studi di Ferrara","sponsor_type":"Other","conditions":"Large Bowel Cancer","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: balanced solutions","description":"during the general anaesthesia until 8 o'clock of the day after the operation the subject will receive only balanced fluids that means balanced crystalloid and colloids dissolved in balanced solution. 12 ml /Kg/h during operation time. ratio 3:1 between crystalloid and colloid."},{"intervention_type":"Behavioral","name":"Behavioral: not balanced","description":"during the operation time until the 8 o'clock of the day after the operation, the subjects will receive only normal saline and colloid dissolved in normal saline."}],"outcomes":[{"outcome_type":"primary","measure":"acid/base disorder","time_frame":"T0: anaesthesia induction (control value) T1: end of surgery T2: 1h after the end of surgery T3: 24h after the beginning of surgery","description":"the investigators assess difference in acid base disorders between the two groups measuring emogas analyses data and blood electrolites levels at the same time (two days)"},{"outcome_type":"secondary","measure":"pro/antiinflammatory cytokine","time_frame":"T0: anaesthesia induction (control value) T1:end of surgery T2: 1h after the end of surgery T3: 24h after the beginning of surgery","description":"-MMP-9 total and active, TIMP-1, IL-6, IL-8, IL-10, mieloperossidasis, ROS, MCP-3 will be measured during the observation period. (two days)"}]}
{"nct_id":"NCT01014624","start_date":"2010-02-28","phase":"Phase 4","enrollment":56,"brief_title":"Prasugrel/Clopidogrel Maintenance Dose Washout Study","official_title":"Recovery of Platelet Function Following Discontinuation of Prasugrel or Clopidogrel Maintenance Dosing in Aspirin-Treated Subjects With Stable Coronary Disease","primary_completion_date":"2010-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-06-30","last_update":"2021-06-28","description":"The primary objective of the study is to describe the cumulative proportion of participants who return to baseline platelet P2Y12 receptor function over time (up to 12 days post last maintenance dose) following discontinuation of prasugrel 10 mg daily x 7 days assessed by Accumetrics VerifyNow P2Y12 reaction units (PRU) and described by Kaplan Meier curves. The primary analysis is descriptive and is intended to provide information relating to the return of baseline platelet function following discontinuation of maintenance therapy with either prasugrel or clopidogrel.","other_id":"CS747S-B-U4001","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":74,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female subjects >/= 18 years and <75 years of age\r\n\r\n          -  Weight >/= 60 kg\r\n\r\n          -  On aspirin therapy (81 mg to 325 mg daily) at the time of screening and able to\r\n             maintain a consistent aspirin dosing regimen from the baseline visit through the final\r\n             study visit\r\n\r\n          -  Subjects who do not have contraindications for a thienopyridine (ie, prasugrel,\r\n             clopidogrel or ticlopidine), and have a history of stable atherosclerosis represented\r\n             by Coronary Artery disease, defined as any of the following:\r\n\r\n               -  chronic stable angina\r\n\r\n               -  Prior history of acute coronary syndrome (>/= 30 days before screening) including\r\n                  unstable angina or acute myocardial infarction (ST elevation Myocardial\r\n                  Infarction [STEMI] or non-ST elevation Myocardial Infarction [NSTEMI]), not\r\n                  currently prescribed or currently on thienopyridine therapy;\r\n\r\n               -  Previous coronary revascularization including percutaneous transluminal coronary\r\n                  angioplasty (PTCA), stent, or coronary artery bypass grafting (CABG) coronary\r\n                  artery disease (>/= 50% obstruction) in at least one coronary vessel after\r\n                  angiography\r\n\r\n          -  Female subjects who meet one of the following:\r\n\r\n               -  Women of childbearing potential with a negative serum pregnancy test at screening\r\n                  who are not breast feeding, do not plan to become pregnant during the study, and\r\n                  agree to use an approved method of birth control during the study. Approved\r\n                  methods of birth control are oral, path, injectable or implantable hormonal\r\n                  contraception, intrauterine device, diaphragm plus spermicide, or female condom\r\n                  plus spermicide. Abstinence, partner's use of condoms, and partner's vasectomy\r\n                  are NOT acceptable methods of contraception.\r\n\r\n               -  Women who have been postmenopausal for at least 1 year or have had a\r\n                  hysterectomy, bilateral salpingo-oophorectomy, or tubal ligation at least 6\r\n                  months prior to signing the informed consent form.\r\n\r\n          -  Subjects with a competent mental condition to provide written informed consent before\r\n             entering the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any other formal indication for the use of a thienopyridine.\r\n\r\n          -  Subjects with a history of refractory ventricular arrhythmias.\r\n\r\n          -  Subjects with a history of an implantable defibrillator device.\r\n\r\n          -  Subjects with a history or evidence of congestive heart failure (New York Heart\r\n             Association [NYHA] Class III or above) within 6 months prior to screening.\r\n\r\n          -  Subjects with significant hypertension (systolic blood pressure >180 mmHg or diastolic\r\n             blood pressure >110 mmHg) at either the time of screening or baseline assessment.\r\n\r\n          -  Bleeding Risk Exclusion Criteria:\r\n\r\n               -  Any known contraindication to treatment with an anticoagulant or antiplatelet\r\n                  agent\r\n\r\n               -  Prior history or clinical suspicion of cerebral vascular malformations,\r\n                  intracranial tumor, transient ischemic attack (TIA), or stroke, or recent history\r\n                  (within 3 months) of head trauma\r\n\r\n               -  Prior history or presence of significant bleeding disorders (eg, hematemesis,\r\n                  melena, severe or recurrent epistaxis, hemoptysis, hematuria, or intraocular\r\n                  bleeding)\r\n\r\n               -  History (within the last 5 years) or presence of gastric ulcers. Previous history\r\n                  of duodenal ulcer is acceptable but must have been successfully surgically or\r\n                  medically treated with no further evidence of disease in the past 6 months (from\r\n                  screening).\r\n\r\n               -  Prior history of abnormal bleeding tendency (ie, prolonged bleeding on dental\r\n                  extraction, tonsillectomy, or previous surgical procedure)\r\n\r\n               -  Known prior history of thrombocytopenia (platelet count < 100,000/mm) or\r\n                  thrombocytosis (platelet count > 500,000/mm) or recent history (within six\r\n                  months) of hemoglobin < 10 mg/dL\r\n\r\n               -  Clinically significant out of range values for prothrombin time, activated\r\n                  partial thromboplastin time (aPTT), platelet count, or hemoglobin at screening,\r\n                  in the investigator's opinion\r\n\r\n               -  History of major surgery, severe trauma, fracture, or organ biopsy within 3\r\n                  months prior to enrollment\r\n\r\n          -  Prior/Concomitant Therapy Exclusion Criteria:\r\n\r\n               -  Subjects taking prasugrel, clopidogrel, ticlopidine, cilostazol, dipyridamole,\r\n                  warfarin, heparin, direct thrombin inhibitors, or glycoprotein IIB/IIIa\r\n                  inhibitors =10 days prior to screening or during study participation\r\n\r\n               -  The use (or planned use) of fibrinolytic agents within 30 days before screening\r\n                  or during study participation\r\n\r\n               -  Subjects receiving treatment with nonsteroidal anti-inflammatory drugs (NSAIDs)\r\n                  or cyclooxygenase-2 (COX-2) inhibitors exceeding 3 doses per week\r\n\r\n               -  Subjects receiving proton pump inhibitors (PPIs), eg, (lansoprazole,\r\n                  esomeprazole, omeprazole, pantoprazole, or rabeprazole) =10 days prior to\r\n                  screening or during study participation\r\n\r\n          -  General Exclusion Criteria:\r\n\r\n               -  Investigator site personnel directly affiliated with the study or immediate\r\n                  family of investigator site personnel directly affiliated with the study.\r\n                  Immediate family is defined as a spouse, parent, child, or sibling, whether\r\n                  biological or legally adopted\r\n\r\n               -  Daiichi Sankyo or Eli Lilly employees\r\n\r\n               -  Currently enrolled in, or discontinued within the last 30 days prior to baseline\r\n                  from, a clinical study involving an off-label use of an investigational drug or\r\n                  device, or concurrently enrolled in a non-observational clinical study or any\r\n                  other type of medical research judged not to be scientifically or medically\r\n                  compatible with this study\r\n\r\n               -  Have previously completed or withdrawn from this study\r\n\r\n               -  Women who are known to be pregnant and/or who receive a positive serum pregnancy\r\n                  test result, who have given birth within the past 90 days, and/or who are\r\n                  breastfeeding\r\n\r\n               -  Results of clinical laboratory tests at the time of screening that are judged to\r\n                  be clinically significant for the subject, as determined by the investigator\r\n\r\n               -  Known allergies or intolerance to aspirin and/or thienopyridines (prasugrel,\r\n                  clopidogrel, or ticlopidine)\r\n\r\n               -  Evidence of significant active neuropsychiatric disease, alcohol abuse or drug\r\n                  abuse, in the investigator's opinion\r\n\r\n               -  Evidence of active hepatic disease, or any of the following; positive human\r\n                  immunodeficiency virus (HIV) antibodies, positive hepatitis C antibody, positive\r\n                  hepatitis B surface antigen; serum alanine transaminase (ALT), aspartate\r\n                  transaminase (AST), or gamma-glutamyltransferase (GGT) >/= 3 times the upper\r\n                  limit of normal (ULN) laboratory reference range; or bilirubin >/= 2 times the\r\n                  ULN of laboratory reference range at screening\r\n\r\n               -  Subjects who are unreliable and unwilling to make themselves available for the\r\n                  duration of the study and who will not abide by the research unit policy and\r\n                  procedure and study restrictions\r\n\r\n          -  Subjects who have had an angiogram <\/= 7 days before randomization\r\n      ","sponsor":"Daiichi Sankyo, Inc.","sponsor_type":"Industry","conditions":"Coronary Artery Disease","interventions":[{"intervention_type":"Drug","name":"Drug: Prasugrel","description":"Prasugrel 10mg tablet administered once daily for 7 days.\r\nAfter a 1-day to 14-day screening period, participants will receive active treatment with either prasugrel or clopidogrel for 7 days. If a participant has not missed more than 1 dose of study medication and is unable to attend Visit 3 (Washout Day 1) the day after the 7th day of study medication, the participant may take up to an additional 3 days of study medication and proceed to Visit 3 the day after the last dose. Active treatment will be followed by a 1-day to 12-day Washout Period depending on the time to reach both of the exit criteria."},{"intervention_type":"Drug","name":"Drug: Clopidogrel","description":"Clopidogrel 75 mg tablet administered once daily for 7 days.\r\nAfter a 1-day to 14-day screening period, participants will receive active treatment with either prasugrel or clopidogrel for 7 days. If a participant has not missed more than 1 dose of study medication and is unable to attend Visit 3 (Washout Day 1) the day after the 7th day of study medication, the participant may take up to an additional 3 days of study medication and proceed to Visit 3 the day after the last dose. Active treatment will be followed by a 1-day to 12-day Washout Period depending on the time to reach both of the exit criteria."}],"outcomes":[{"outcome_type":"primary","measure":"The Time to Return to Baseline Platelet Function as Assessed by P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNOW P2Y12 Device Based on the Primary Definition of Return to Baseline","time_frame":"up to 12 days after last dose","description":"On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the participant met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to 20%. The results are expressed as cumulative percentage of participants."},{"outcome_type":"primary","measure":"The Time to Return to Baseline Platelet Function as Assessed by P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNOW P2Y12 Device Based on the Secondary Definition of Return to Baseline","time_frame":"up to 12 days after last dose","description":"On the first day of the Washout Period (visit 3), the blood draw for platelet function testing was obtained 24 hours (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the participant met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to 20%."},{"outcome_type":"secondary","measure":"Day at Which 50%, 75%, and 90% of Participants Returned to Baseline Platelet Function Based on Primary Definition of Return to Baseline Using the Primary Population","time_frame":"up to 12 days after last dose","description":"On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/-6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the participants met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%."},{"outcome_type":"secondary","measure":"Day at Which 50%, 75%, and 90% of Participants Returned to Baseline Platelet Function Based on Secondary Definition of Return to Baseline Using the Primary Population","time_frame":"up to 12 days after last dose","description":"On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/-6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the participant met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%."},{"outcome_type":"secondary","measure":"Day at Which 50%, 75%, and 90% of Participants Returned to Baseline Platelet Function Based on the Primary Definition of Return to Baseline Using the Responder Population","time_frame":"up to 12 days after last dose","description":"On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/-6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the participant met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%."},{"outcome_type":"secondary","measure":"Day at Which 50%, 75%, and 90% of Participants Returned to Baseline Platelet Function Based on the Secondary Definition of Return to Baseline Using the Responder Population","time_frame":"up to 12 days after the last dose","description":"On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hour (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the participant met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to (<=) 20%."},{"outcome_type":"secondary","measure":"Percentage of Inhibition of Platelet Aggregation on Washout Day 1","time_frame":"Washout Day 1","description":"Inhibition of platelet aggregation was assessed by Accumetrics VerifyNow® P2Y12 reaction units (PRU). On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hour (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the participant met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to 20%."},{"outcome_type":"secondary","measure":"Time to Return to Baseline PRU for the Primary Population Using the Primary Definition of Return to Baseline in Relation to the Inhibition of Platelet Aggregation 24 Hours Following the Last Maintenance Dose","time_frame":"up to 12 days after the last dose","description":"Time to return to baseline PRU (<= 60 units of baseline) dependent upon baseline PRU and platelet % inhibition on Washout Period Day 1 but independent of treatment. The following regression model was derived for predicting number of days to return to baseline PRU where PI(1) represents platelet percentage inhibition on Washout Day 1. Number days to return to baseline PRU derived from: Number days to return to baseline PRU=-3.350+0.079*PI(1)+0.014*baseline PRU. The predicted number of days to return to baseline based on device-derived platelet percentage inhibition is reported for each treatment group."}]}
{"nct_id":"NCT01077089","start_date":"2010-02-28","enrollment":14,"brief_title":"Effects of Transport on Patients With Traumatic Brain Injury","official_title":"Effects of Transport on Patients With Traumatic Brain Injury","primary_completion_date":"2012-10-31","study_type":"Observational","rec_status":"Completed","completion_date":"2012-10-31","last_update":"2013-02-25","description":"Hospitalized patients are often moved from their rooms to other hospital locations, particularly imaging facilities. For patients with traumatic brain injury, such movements may raise the risk of secondary brain injuries. The purpose of this study is to monitor brain injured patients during transport and to measure the resulting changes in intracranial pressure. This will allow for documentation of the frequency of secondary injury and help in understanding their causes.","other_id":"Dorlac-2010-01","observational_model":"Ecologic or Community","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients with traumatic brain injury","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  presence of traumatic brain injury and intracranial pressure monitoring\r\n\r\n          -  requiring mechanical ventilation\r\n\r\n          -  presence of an indwelling arterial catheter for monitoring blood pressure\r\n\r\n          -  Age of at least 18 years\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Age less than 18 years\r\n\r\n          -  diagnosis of brain death\r\n\r\n          -  non-English speakers\r\n\r\n          -  prisoners\r\n\r\n          -  mentally ill persons\r\n      ","sponsor":"University of Cincinnati","sponsor_type":"Other","conditions":"Traumatic Brain Injury","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Incidence of adverse events during transport.","time_frame":"Each transport event"},{"outcome_type":"secondary","measure":"Incidence of elevated heart rate during transport.","time_frame":"Each transport event"},{"outcome_type":"secondary","measure":"Incidence of transport events during which SpO2 remains below 90% for 1 minute or longer","time_frame":"Each transport event"},{"outcome_type":"secondary","measure":"Transport events during which systolic blood pressure remains below 90 mmHg for 5 minutes or longer","time_frame":"Each transport event"},{"outcome_type":"secondary","measure":"Transport events during which mean arterial blood pressure remains below 60 mmHg for 5 minutes or longer","time_frame":"Each transport event"},{"outcome_type":"secondary","measure":"Transport events during which intracranial pressure exceeds 20 mmHg for 5 minutes or longer","time_frame":"Each transport event"},{"outcome_type":"secondary","measure":"Transport events during which cerebral perfusion pressure remains below 70 mmHg for 5 minutes or longer","time_frame":"Each transport event"},{"outcome_type":"secondary","measure":"Number of instances of physiological change that require caregiver intervention, such as ventilator manipulation or drug therapy","time_frame":"Each transport event"}]}
{"nct_id":"NCT01087814","start_date":"2010-02-28","phase":"Phase 4","enrollment":16,"brief_title":"Sustiva Levels With Use of a Gel Capsule","official_title":"Effect of Encapsulation Upon Efavirenz Pharmacokinetics","primary_completion_date":"2010-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-09-30","last_update":"2017-03-09","description":"We are studying if putting a gel capsule over a standard HIV drug changes the ability of the body to absorb the drug. This is important because we want to be able to study new HIV drugs against the most common drugs used today and the most common is Sustiva, which is also called efavirenz. We will give you Sustiva every day for 5 days and draw blood to see how much is absorbed. Then we will give you Sustiva that has a gel capsule over it for 5 days and we will draw blood to see how much is absorbed.","other_id":"0910M73917","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Basic Science","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  HIV-negative, proven by ELISA\r\n\r\n          -  Age:  18 years old\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Psychiatric or psychological illness that would make adherence to protocol procedures\r\n             unlikely.\r\n      ","sponsor":"University of Minnesota","sponsor_type":"Other","conditions":"HIV|HIV Infections","interventions":[{"intervention_type":"Drug","name":"Drug: Efavirenz","description":"Subject will take efavirenz for 5 days."},{"intervention_type":"Drug","name":"Drug: Over-encapsulated efavirenz","description":"Subject will take efavirenz that has been over-encapsulated with a gel capsule for 5 days."}],"outcomes":[{"outcome_type":"primary","measure":"Serum Levels of Efavirenz","time_frame":"5th day of taking drug","description":"Serum levels of efavirenz were measured on the fifth day of taking efavirenz (tablet) and the fifth day of taking an overencapsulated efavirenz."}]}
{"nct_id":"NCT01078844","start_date":"2010-02-28","phase":"N/A","enrollment":4,"brief_title":"Memantine in Adult Autism Spectrum Disorder","official_title":"Memantine in Adult Autism Spectrum Disorder","primary_completion_date":"2010-07-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2010-07-31","last_update":"2017-07-26","description":"The purpose of this study is to see if memantine is helpful in managing problematic symptoms in adults with autism, Asperger's disorder, or Pervasive Developmental Disorder not otherwise specified (NOS).","other_id":"NA_00015760","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":85,"population":"","criteria":"\n        Inclusion criteria\r\n\r\n          -  Participant is currently in treatment in the Johns Hopkins Bayview Medical Center\r\n             (JHBMC)\r\n\r\n          -  Participant has a diagnosis of:\r\n\r\n               -  Autistic Disorder\r\n\r\n               -  Asperger's Disorder\r\n\r\n               -  Pervasive Developmental Disorder (PDD) NOS\r\n\r\n          -  Participant meets one of the following criteria:\r\n\r\n               -  CGI-S >= 4 (CGI-S: ________)\r\n\r\n               -  Participant has the following problematic behaviors (at least one) that might be\r\n                  expected to benefit from memantine:\r\n\r\n                    1. _____________________________________________\r\n\r\n                    2. _____________________________________________\r\n\r\n                    3. _____________________________________________\r\n\r\n        Exclusion criteria\r\n\r\n        The patient meets none of the following criteria (mark if absent):\r\n\r\n          -  Active seizures (Patients with a history of seizures, who have been seizure-free on an\r\n             antiepileptic regimen for six months or more would be eligible).\r\n\r\n          -  Rett's Syndrome or Childhood Disintegrative Disorder\r\n\r\n          -  Active treatment with an acetylcholinesterase inhibitor\r\n\r\n          -  Prior or current treatment with memantine\r\n\r\n          -  Current treatment with lamotrigine\r\n\r\n          -  Genetic, metabolic or degenerative disorder (excepting Fragile X).\r\n\r\n          -  Brain malformation or known severe brain trauma\r\n\r\n          -  Pregnancy or breastfeeding\r\n\r\n          -  Glomerular Filtration Rate (GFR) < 30 mL/min\r\n      ","sponsor":"Johns Hopkins University","sponsor_type":"Other","conditions":"Autism|Asperger's Disorder|Pervasive Developmental Disorder NOS","interventions":[{"intervention_type":"Drug","name":"Drug: memantine","description":"memantine 5-20 mg daily"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Look-alike placebo"}],"outcomes":[{"outcome_type":"primary","measure":"Clinical Global Impression-Scale(CGI-S)","time_frame":"12 weeks"}]}
{"nct_id":"NCT01580098","start_date":"2010-02-28","phase":"N/A","enrollment":193,"brief_title":"Medium-term Health Coaching and Life-long Monitoring in Diabetes Mellitus","official_title":"Regions of Europe Working Together for Health (Renewing Health)","primary_completion_date":"2013-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-02-28","last_update":"2015-09-23","description":"Evaluation whether the introduction of large-scale personalized and technology supported telemonitoring and health coaching interventions produces benefits in terms of health related quality of life, health status and empowerment of patients with type 2 diabetes mellitus. In addition, the trials evaluate the economical and organizational impact of the new services and examine their acceptability by patients and health professionals.","other_id":"D250487","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  T2DM diagnosed > 3 months prior to the enrollment\r\n\r\n          -  HbA1c >= 6,5 %\r\n\r\n          -  Capability of filling questionnaires by their own language\r\n\r\n          -  Being able to use the devices provided\r\n\r\n          -  Being cognitively able to participate\r\n\r\n        Exclusion Criteria:\r\n      ","sponsor":"Landeskrankenanstalten-Betriebsgesellschaft","sponsor_type":"Industry","conditions":"Diabetes Mellitus Type 2","interventions":[{"intervention_type":"Other","name":"Other: Self-monitoring for patients with Diabetes mellitus type 2","description":"Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital."},{"intervention_type":"Other","name":"Other: Nurse-monitoring for patients with Diabetes mellitus type 2","description":"Nurses are submitting the vital parameters of the patient via mobile device."}],"outcomes":[{"outcome_type":"primary","measure":"Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire","time_frame":"12 months","description":"The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status.\r\nMearurement at the beginning and after 12 months, Scales from 0 to 100, higher values represent a better outcome; Data are mean scores (SD); differences between groups after 12 month were compared by using Mann-Whitney-U-tests."},{"outcome_type":"primary","measure":"HbA1c","time_frame":"12 months","description":"HbA1c was taken at the beginning of the study and after 12 months."},{"outcome_type":"secondary","measure":"Blood Pressure","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Blood Lipids","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Body Weight","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Medication Changes","time_frame":"12 months","description":"Insulin, Change? -> Yes/No"},{"outcome_type":"secondary","measure":"Presence of Diabetic Complications","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Number of Hospitalisations","time_frame":"12 months","description":"The number of inpatient stays comparing intervention and control group was conducted."}]}
{"nct_id":"NCT01058668","start_date":"2010-02-28","phase":"Phase 3","enrollment":497,"brief_title":"Safety and Efficacy of Cariprazine for Bipolar I Disorder","official_title":"A Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of Cariprazine in Patients With Acute Mania Associated With Bipolar I Disorder","primary_completion_date":"2011-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-12-31","last_update":"2017-04-12","description":"The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder.","other_id":"RGH-MD-33","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients who have provided informed consent prior to any study specific procedures\r\n\r\n          -  Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders,\r\n             Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder, as\r\n             confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual\r\n             of Mental Disorders, Fourth Edition (SCID) manic or mixed type with or without\r\n             psychotic symptoms\r\n\r\n          -  Voluntarily hospitalized for current manic episode\r\n\r\n          -  Patients with normal physical examination, laboratory, vital signs,and/ or\r\n             electrocardiogram (ECG)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I\r\n             disorder that was the primary focus of treatment within the previous six months\r\n      ","sponsor":"Forest Laboratories","sponsor_type":"Industry","conditions":"Mania|Bipolar I Disorder","interventions":[{"intervention_type":"Drug","name":"Drug: Cariprazine","description":"Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for three weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for three weeks."}],"outcomes":[{"outcome_type":"primary","measure":"Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3","time_frame":"Baseline, Week 3","description":"The YMRS is an 11-item scale that assesses manic symptoms based on the participant's perception of his or her condition over the previous 48 hours, as well as the physician's clinical observations during the interview. The 11-items are elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, rate and amount of speech, language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. The severity of the abnormality for 7-items are rated on a five-point scale (0-4) and 4-items on a nine-point scale (0-8). The individual scores are summed for a total possible score of 0 (best) to 60 (worst). A negative change from Baseline indicates improvement. Analysis is a mixed model for repeated measurements (MMRM) using observed cases, with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix."},{"outcome_type":"secondary","measure":"Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3","time_frame":"Baseline, Week 3","description":"The CGI-S measures the investigator's assessment of overall severity of the participant's illness compared with the severity of illness in other patients the physician has observed using a 7-point scale (1=Normal, not ill at all to 7= Among the most extremely ill participants). A negative change from Baseline indicates improvement. Analysis is based on a MMRM using the observed cases data, with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix."}]}
{"nct_id":"NCT01532167","start_date":"2010-02-28","enrollment":26,"brief_title":"Impact and Utility of PET Versus Clinical Score for the Assessment of Inflammatory Activity in Takayasu Arteritis","official_title":"Impact and Utility of Positron Emission Tomography (PET) for the Assessment of Inflammatory Activity Arteritis Versus Clinical Score and Laboratory Values in Takayasu Arteritis: a Cohort Study","primary_completion_date":"2011-02-28","study_type":"Observational","rec_status":"Completed","completion_date":"2011-02-28","last_update":"2012-03-27","description":"The purpose of this study is to demonstrate that [18F]FDG PET is a a better method than clinical and laboratory values for the identification and assessment of inflammatory activity in patients with Takayasu Arteritis (TA), allowing long-term follow-up with a precise evaluation of response to therapy.","other_id":"12-755","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","population":"Patients treated for TA at our institution's immunology outpatient clinic were included\r\n        between.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  TA was diagnosed if the patient met 3 or more ACR criteria.\r\n      ","sponsor":"Instituto Nacional de Cardiologia Ignacio Chavez","sponsor_type":"Other","conditions":"Takayasu Arteritis","interventions":{},"outcomes":{}}
{"nct_id":"NCT01080209","start_date":"2010-02-28","phase":"Phase 2","enrollment":215,"brief_title":"Safety Extension Study to Evaluate the Biodegradation of the Brimonidine Tartrate Posterior Segment Drug Delivery System","primary_completion_date":"2014-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-02-28","last_update":"2015-02-20","description":"This study will evaluate the biodegradation of the brimonidine tartrate posterior segment drug delivery system.","other_id":"190342-033D","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Received the most recent sham or active study treatment of intravitreal Brimo PS DDS\r\n             no later than 36 months prior to entry into this study and have either completed their\r\n             previous study, or have exited early from their previous study for any reason\r\n\r\n          -  Applicable studies: Previous Allergan intravitreal Brimo PS DDS treatment studies\r\n\r\n        Exclusion Criteria:\r\n\r\n        - None\r\n      ","sponsor":"Allergan","sponsor_type":"Industry","conditions":"Patients Who Participated in an Intravitreal Brimo PS DDS Study","interventions":[{"intervention_type":"Drug","name":"Drug: Brimo PS DDS","description":"Patients who received Brimo PS DDS intravitreal implant in a previous study."},{"intervention_type":"Other","name":"Other: Sham","description":"Patients who recieved sham in a previous study."}],"outcomes":[{"outcome_type":"primary","measure":"Number of Patients With No Visible Implants in the Study Eye","time_frame":"Month 36","description":"Implants administered during the parent study are evaluated during this study to determine if they have completely degraded. The time frame is evaluated from the point of the first treatment in the parent study."},{"outcome_type":"secondary","measure":"Number of Patients With Vision Loss in the Study Eye","time_frame":"Baseline of Parent Study, Month 36","description":"Vision loss is assessed by Best Corrected Visual Acuity (BCVA) in the study eye. BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). Severe vision loss is a ≥30 letter decrease in BCVA. Moderate vision loss is a ≥15 and <30 letter decrease in BCVA. No or mild vision loss is <15 letter decrease in BCVA. Baseline of the parent study is defined as the point of the first study treatment."}]}
{"nct_id":"NCT01086384","start_date":"2010-02-22","phase":"Phase 3","enrollment":2020,"brief_title":"Asthma Exacerbation Study","official_title":"A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects With Asthma","primary_completion_date":"2011-09-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-09-15","last_update":"2018-01-24","description":"This study will establish the safety as well as demonstrate benefit of the addition of a LABA to an ICS by utilizing an endpoint (time to first severe asthma exacerbation) that informs on both safety and efficacy.","other_id":"106837","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":12,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Clinical diagnosis of asthma\r\n\r\n          -  Reversibility FEV1 of twelve percent or greater and two hundred milliliters and\r\n             greater approximately ten to forty minutes following two to four inhalations of\r\n             albuterol\r\n\r\n          -  FEV1 of fifty to ninety percent of predicted\r\n\r\n          -  Currently using inhaled corticosteroid therapy\r\n\r\n          -  History of one or more asthma exacerbations requiring treatment with oral/systemic\r\n             corticosteroids or emergency department visit or in-patient hospitalization in\r\n             previous year\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of life threatening asthma in previous 5 years (requiring intubation, and/or\r\n             associated with hypercapnia, hypoxic seizure or respiratory arrest\r\n\r\n          -  Respiratory infection or oral candidiasis\r\n\r\n          -  - Uncontrolled disease or clinical abnormality\r\n\r\n          -  Allergies\r\n\r\n          -  Taking another investigational medication or prohibited medication\r\n      ","sponsor":"GlaxoSmithKline","sponsor_type":"Industry","conditions":"Asthma","interventions":[{"intervention_type":"Drug","name":"Drug: Fluticasone Furoate/GW642444","description":"Combination inhaled corticosteroid and long-acting beta2-agonist"},{"intervention_type":"Drug","name":"Drug: Fluticasone furoate","description":"Inhaled corticosteroid"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants With 1 or More Severe Asthma Exacerbations","time_frame":"Baseline to Follow-up (up to 76 weeks of treatment)","description":"Asthma is a medical condition that causes narrowing of the small airways in the lungs. A severe asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. Only events deemed by the adjudication committee to be severe asthma exacerbations were used in the analysis of severe asthma exacerbations. The time to the first severe asthma exacerbation was analyzed using a Cox proportional hazards regression model, adjusting for Baseline disease severity (Baseline forced expiratory volume in one second [FEV1, maximum amount of air forcefully exhaled in one second]), sex, age, and region."},{"outcome_type":"secondary","measure":"Number of Severe Asthma Exacerbations","time_frame":"Baseline to Follow-up (up to 76 weeks of treatment)","description":"A severe asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. A participant may have had one or more exacerbations."},{"outcome_type":"secondary","measure":"Change From Baseline in Evening Pre-dose Trough FEV1 at Week 36","time_frame":"Baseline and Week 36","description":"Evening pre-dose trough (lowest value) forced expiratory volume in one second (FEV1) was measured using spirometry equipment that met or exceeded the minimal performance recommendations of the American Thoracic Society. FEV1 is a measure of the maximum amount of air forcefully exhaled in one second. Change from Baseline in evening pre-dose FEV1 was analyzed using an Analysis of Covariance (ANCOVA) model with effects due to Baseline FEV1, sex, age, region, and treatment. Change from Baseline was calculated as the Week 36 value minus the Baseline value."}]}
{"nct_id":"NCT01294852","start_date":"2010-01-31","phase":"N/A","enrollment":100,"brief_title":"Comparison of Two Strategies for Surfactant Prophylaxis in Premature Infants","official_title":"A Randomized Trial: Comparison of Two Strategies for Surfactant Prophylaxis in Premature Infants","primary_completion_date":"2012-01-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2012-06-30","last_update":"2011-06-22","description":"The purpose of this study is to determine whether the immediate bolus strategy combined with early nasal CPAP (nCPAP) treatment could decrease the subsequent need for ventilation compared to the administration of surfactant prophylaxis at 15 minutes after birth with early nCPAP in premature infants.","other_id":"Ankara University-01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"All","maximum_age":2,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Premature infants born before 28 weeks' gestation\r\n\r\n          -  Premature infants born at 29 to 30 weeks' gestation who did not receive antenatal\r\n             steroid were randomized before delivery\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Infants died at delivery room\r\n      ","sponsor":"Ankara University","sponsor_type":"Other","conditions":"Premature Birth|Premature Lungs","interventions":[{"intervention_type":"Other","name":"Other: surfactant prophylaxis","description":"Premature infants born before 28 weeks' gestation and infants born at 29 to 30 weeks' gestation who did not receive antenatal steroid were randomized before delivery to receive either immediate bolus or post-resuscitation surfactant prophylaxis at 15 minutes after birth. Those infants who were randomized to immediate bolus surfactant were intubated as rapidly as possible after birth, were administered 100 mg/kg surfactant (Curosurf[Chiesi, Farmaceutici, Parma, Italy]), and received standard resuscitation measures as indicated. Those infants who were randomized to post-resuscitation surfactant received standard resuscitation measures first, were intubated electively at 15 minutes after birth and received 100 mg/kg surfactant (Curosurf[Chiesi, Farmaceutici, Parma, Italy])."}],"outcomes":[{"outcome_type":"primary","measure":"ventilatory requirement","time_frame":"within the first 5 days of life","description":"Infants with RDS may require mechanical ventilation. Mechinal ventilation causes volu- and barotrauma in the lungs and associated morbidities. The earlier surfactant is given, the better it works. So immediate surfactant prophylaxis given before the first breath may decrease the requirement for mechanical ventilation compared with surfactant prophylaxis given at 15 minutes of age after resuscitation and stabilization."},{"outcome_type":"secondary","measure":"Pneumothorax","time_frame":"first 72 hours of life"},{"outcome_type":"secondary","measure":"Pulmonary hemorrhage","time_frame":"first 72 hours of life"},{"outcome_type":"secondary","measure":"patent ductus arteriosus","time_frame":"first one week"},{"outcome_type":"secondary","measure":"necrotizing enterocolitis","time_frame":"first one month"},{"outcome_type":"secondary","measure":"retinopathy of prematurity","time_frame":"first two months"},{"outcome_type":"secondary","measure":"intraventricular hemorrhage","time_frame":"first one week"},{"outcome_type":"secondary","measure":"bronchopulmonary dysplasia","time_frame":"first two months"},{"outcome_type":"secondary","measure":"duration of hospitalization","time_frame":"one year"},{"outcome_type":"secondary","measure":"mortality","time_frame":"one year"}]}
{"nct_id":"NCT01057706","start_date":"2010-01-31","phase":"Phase 2/Phase 3","enrollment":200,"brief_title":"Chiropractic and Exercise Management of Spinal Dysfunction in Seniors","official_title":"Chiropractic and Exercise Management of Spinal Dysfunction in Seniors","primary_completion_date":"2013-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-12-31","last_update":"2015-05-06","description":"This study will compare the effectiveness of chiropractic and exercise treatment in the short- and long-term, when managing chronic neck and back disability in seniors over the age of 65 years.","other_id":"R18HP15127","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  65 years of age and older\r\n\r\n          -  independent ambulation and community dwelling\r\n\r\n          -  stable medication plan\r\n\r\n          -  neck-related disability (minimal score of 10% on Neck Disability Index)\r\n\r\n          -  back-related disability (minimal score of 10% on Oswestry Disability Index)\r\n\r\n          -  minimum combined disability score (above) of 25% at first baseline screening\r\n\r\n          -  at least 12 week duration of neck and back related disability\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  moderate or severe cognitive impairment\r\n\r\n          -  untreated clinical depression\r\n\r\n          -  surgical spinal fusion or multiple incidents of spinal surgery\r\n\r\n          -  contraindications to spinal manipulation or exercise\r\n\r\n          -  ongoing, non-pharmacological treatment for a spinal condition\r\n      ","sponsor":"Northwestern Health Sciences University","sponsor_type":"Other","conditions":"Neck Disability|Back Disability","interventions":[{"intervention_type":"Other","name":"Other: chiropractic","description":"spinal manipulation and mobilization"},{"intervention_type":"Behavioral","name":"Behavioral: exercise","description":"strengthening, stretching, balance"}],"outcomes":[{"outcome_type":"primary","measure":"Patient-rated neck and back disability","time_frame":"9 months"},{"outcome_type":"secondary","measure":"Pain","time_frame":"9 and 18 months"},{"outcome_type":"secondary","measure":"Improvement","time_frame":"9 and 18 months"},{"outcome_type":"secondary","measure":"General health","time_frame":"9 and 18 months"},{"outcome_type":"secondary","measure":"Medication use","time_frame":"9 and 18 months"},{"outcome_type":"secondary","measure":"Satisfaction","time_frame":"9 and 18 months"}]}
{"nct_id":"NCT01130714","start_date":"2010-01-31","phase":"N/A","enrollment":15,"brief_title":"Resistance Training in Lung Cancer Patients on Chemotherapy","official_title":"Effectiveness of a Resistance Training Program on Inflammatory Markers and Chemotherapy Completion in Lung Cancer Patients on Chemotherapy","primary_completion_date":"2012-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-07-31","last_update":"2015-08-20","description":"The purpose of this study is to examine the effectiveness of a resistance training program on reducing systemic inflammation and improving chemotherapy completion in lung cancer patients being treated with curative intent chemotherapy.","other_id":"UMCIRB 09-0725","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":21,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically diagnosed with lung cancer\r\n\r\n          -  Stage I, II, or III\r\n\r\n          -  Eligible for chemotherapy with curative intent\r\n\r\n          -  21 years of age or older\r\n\r\n          -  Approval to participate in study by treating oncologist or family physician\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Unstable cardiac disease\r\n\r\n          -  Untreated bone or brain metastases\r\n      ","sponsor":"East Carolina University","sponsor_type":"Other","conditions":"Inflammation|Lung Cancer","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Exercise","description":"Resistance training with resistance bands."}],"outcomes":[{"outcome_type":"primary","measure":"Systemic inflammation measured by c-reactive protein.","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"Chemotherapy completion","time_frame":"12 weeks"}]}
{"nct_id":"NCT01300949","start_date":"2010-01-31","phase":"N/A","enrollment":314,"brief_title":"Spaeth/Richman Contrast Sensitivity Test","official_title":"Validation and Reproducibility of Spaeth/Richman Contrast Sensitivity Test","primary_completion_date":"2014-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-04-30","last_update":"2018-12-11","description":"The Spaeth-Richman Contrast Sensitivity (SPARCS) test is a new method of assessing contrast sensitivity. The test, another way to measure vision, is performed on any standard computer with internet access. Patients will be tested with SPARCS and with the standard Pelli-Robson contrast test.","other_id":"10-998","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","intervention_model_description":"Contrast sensitivity, another means of testing vision, will be measured two ways for each participant. One method uses the Pelli-Robson Contrast Sensitivity Chart which is mounted on the wall, the other method uses a new computerized program called Spaeth/Richman Contrast Sensitivity Test also known as SPARCS.","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18 yrs of age and older\r\n\r\n          -  able to provide fully informed consent\r\n\r\n             70 controls (patients with no ocular disease affecting visual acuity or visual\r\n             function), 10 from each decade of life: 20-30, 30-40, 40-50, 50-60, 60-70, 70-80, 80+.\r\n\r\n             105 patients with ocular hypertension or any type of glaucoma (15 subjects per age\r\n             decade). Glaucoma patients will not have macular degeneration or visual acuity\r\n             affected by any function other than glaucoma.\r\n\r\n             40 patients with macular degeneration: 10 with visual acuity 20/40 or better, 10 with\r\n             visual acuity between 20/40 and 20/60, 10between 20/100 and 20/400, and 10 with 20/400\r\n             or worse.\r\n\r\n             40 patients with cataracts: 10 with lens opacity 1+nuclear sclerosis, 10 with 2 +\r\n             nuclear sclerosis, 10 with 3 + nuclear sclerosis, 10 with 4 + nuclear sclerosis.\r\n\r\n             60 patients with refractive error: 10 with myopia -5 diopters or greater, 10 with\r\n             myopia between -5 and -2.5, 10 with myopia between -2.5 and -0.5, 10 with myopia\r\n             between -0.5 and 0.5, 10 with myopia between 0.5 and 2.5, and 10 with myopia > 2.5.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  any other diseases affecting visual acuity\r\n      ","sponsor":"Wills Eye","sponsor_type":"Other","conditions":"Glaucoma","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Spaeth/Richman Contrast Sensitivity Test","description":"internet based computerized contrast sensitivity test measuring central and peripheral vision using black and white stripes that decrease in contrast by fading to a white background."},{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Pelli-Robson Contrast Sensitivity Chart","description":"wall chart contrast sensitivity test measuring central vision using black letters that decrease in contrast by fading to a white background."}],"outcomes":[{"outcome_type":"primary","measure":"Contrast Sensitivity, Another Means of Testing Vision","time_frame":"duration of 1 eye exam, approximately 1 hour","description":"Contrast Sensitivity, a vision measurement, is performed with the Spaeth Richmond Contrast Sensitivity (SPARCS) test. This is a computerized measurement of vision in the central and peripheral fields using black and white stripes. Black stripes decrease in contrast becoming fainter and harder to see until they blend with the white background. Measurements are assessed in five areas of the visual field . Test results are reported for each area ranging from 0 to 20 (0 means can't see stripes; 20 means sees all stripes). Results from all 5 areas are added making the total SPARCS score range 0 - 100 where 0 means poor vision and 100 means best vision. The test takes an average of 3 minutes per eye. The eye not being tested is covered with a patch."}]}
{"nct_id":"NCT01268436","start_date":"2010-01-31","enrollment":64,"brief_title":"Cohort Comparison of Dental Nerve Block With Other Forms of Analgesia in Alleviating the Pain of Toothache","official_title":"Cohort Comparison of Dental Nerve Block With Other Forms of Analgesia in Alleviating the Pain of Toothache","primary_completion_date":"2012-11-30","study_type":"Observational","rec_status":"Completed","completion_date":"2012-11-30","last_update":"2014-03-24","description":"Toothache is a common source of pain for Emergency Department patients. There are several common ways to control the pain of toothache. But we do not know if any one of them is more effective than another. It is also possible that how we take care of your pain in the Emergency Department will influence the level of pain you experience one or two days from now. This study seeks to answer these questions.","other_id":"2709","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Adult patients identified by ED providers as having dental pain will be screened for\r\n        enrollment.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  > 18 years, pain in any tooth\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  duration of pain > 96 hours\r\n\r\n          -  oral trauma within 96 hours of presentation\r\n\r\n          -  facial or neck swelling\r\n\r\n          -  pericoronitis\r\n\r\n          -  visual impairment to less than finger counting within three feet\r\n      ","sponsor":"Albany Medical College","sponsor_type":"Other","conditions":"Tooth Pain","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Visual Analog Pain Scale","time_frame":"Before and After treatment of tooth pain","description":"Is there any change in patient report of pain using the Visual Analog Pain Scale before and after treatment."},{"outcome_type":"secondary","measure":"Need for additional treatment","time_frame":"while in the Emergency Department","description":"Does patient require addtional/repeated analgesia or rescue medication?"}]}
{"nct_id":"NCT03382665","start_date":"2010-01-31","enrollment":70,"brief_title":"Post-market Surveillance Study With the HYPERION Hip Endoprosthesis System in Defect Reconstruction","official_title":"Prospective, Multi - Centre Clinical Evaluation of the Performance and Safety of the HYPERION Hip Endoprosthesis System in Defect Reconstruction","primary_completion_date":"2017-08-31","study_type":"Observational","rec_status":"Terminated","completion_date":"2018-03-31","last_update":"2020-08-21","description":"The study is a multi-center, prospective, non-controlled, consecutive cohort post market surveillance study. The objective of this study is to obtain survival and clinical outcome data on the Hyperion system in primary and revision total hip arthroplasty.","other_id":"BMETEU.CR.EU79.10","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"Because of the studiesindications it is assumed that patients have a relatively high (> 60\r\n        Jahre) age at the time of their operations. Therefore a higher letality and a higher\r\n        drop-out-rate is expected compared to study populations of primary hip replacement. To\r\n        reach the necessery power for this clinical study at least 70 patients should be recruited.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patient age at least 18 years\r\n\r\n          -  Fully conscious and capable patients\r\n\r\n          -  Signed informed consent\r\n\r\n          -  Stationary treatment\r\n\r\n          -  Merle d'Aubign < 12 Points, WOMAC Score > 25 Points\r\n\r\n          -  Patients with at least one of the following indications:\r\n\r\n        Indications for primary hip replacement:\r\n\r\n          -  Non-inflammatory diseases of the joints such as osteoarthritis and avascular necrosis\r\n             (head necrosis)\r\n\r\n          -  Rheumatoid arthritis\r\n\r\n          -  Functional deformities\r\n\r\n          -  Provision of non-endoprosthetic previous operations of the hip joint (e.g.,\r\n             transposition osteotomies)\r\n\r\n          -  Treatment of pseudarthrosis, femoral neck and trochanter fractures, as well as\r\n             fractures of the proximal femur affecting the head, which can not be treated by other\r\n             techniques\r\n\r\n        Revision THA:\r\n\r\n          -  Revision of endoprosthesis-treated hips as a result of septic or aseptic loosening,\r\n             sub- and periprosthetic fractures or material failure (eg fracture of the prosthesis)\r\n\r\n          -  Bridging of large bone defects (precondition: suitable proximal bone situation for a\r\n             stable anchorage), i.e. for tumors\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Infections\r\n\r\n          -  Patients under 18 years\r\n\r\n          -  Pregnant or breastfeeding patients\r\n\r\n          -  Known alcohol abuse (at least 20 g alcohol per day for women and at least 40 g per day\r\n             for men) or drug abuse\r\n\r\n          -  Legal incapacity or restricted capacity\r\n\r\n          -  Participation in another clinical trial within the last 30 days or planned\r\n             participation in another clinical trial within the next 3 months\r\n\r\n          -  Patients who are unable to attend to follow-up\r\n      ","sponsor":"Zimmer Biomet","sponsor_type":"Industry","conditions":"Osteoarthritis|Avascular Necrosis|Rheumatoid Arthritis|Functional Deformities|Pseudoarthrosis|Revision of Endoprosthesis-treated Hips|Fracture, Proximal Humeral|Provision of Non-endoprosthetic Previous Operations of the Hip Joint (e.g., Transposition Osteotomies)|Femur Fracture|Pseudarthrosis|Trochanteric Fractures|Bridging of Large Bone Defects|Revisions","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Pain and Walking Ability Determined by a Merle d' Aubigné Score Increase of >4 Points.","time_frame":"baseline/Pre-op and 2 years (+/- 2 months)","description":"Pain and walking ability determined by a Merle d' Aubigné Score (MdA) increase of >4 points compared to the pre-operative score points.\r\nThe patients were evaluated by the Merle d'Aubigné hip score, which evaluates pain, gait and mobility, on a scale of 1 to 6 for each item, where 1 indicates the worst and 6, the best state of the patient. The value of each item is summed to a total score. The total minimum score reached is 3, and the maximum is 18. Higher scores mean a better outcome."},{"outcome_type":"primary","measure":"Implant Survival Measured by the Number of Revisions.","time_frame":"2 years (+/- 2 month)","description":"Implant survival is measured by the number of revisions and analysed by the Kaplan Meier method."},{"outcome_type":"primary","measure":"WOMAC Score Value Decrease at 2-years in Min. 25 Points Compared to the Pre-operative WOMAC Score Value","time_frame":"baseline/Pre-op and 2 years (+/- 2 months)","description":"at 2-years post op, WOMAC score (Western Ontario and McMaster Universities Arthritis Index) has to be at least 25 points lower compared to preop values\r\nScale: min 0-Max 100; Higher values mean worse outcome"}]}
{"nct_id":"NCT01358656","start_date":"2010-01-31","phase":"N/A","enrollment":40,"brief_title":"Anterior Cruciate Ligament Reconstruction Using Single Bundle and Double Bundle Techniques","official_title":"Comparison of the Anterior Cruciate Ligament Reconstruction Using Single Bundle and Double Bundle Techniques: Prospective Clinical Study","primary_completion_date":"2011-07-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2012-01-31","last_update":"2011-05-24","description":"Anterior Cruciate Ligament (ACL) reconstruction surgery has greatly advanced over the last 20 years. However, data in the literature reveal that approximately 15-25% of patients undergoing surgery still do not present optimal outcomes, which suggests that there is room for improvement of the procedure. A possible explanation for this fact is that most ACL reconstructions consider only one of the functional bundles of the ligament. Our hypothesis is that the ACL reconstruction with the double-bundle technique will be effective in reducing the patients' rotation of the knee joint for high-demanding tasks compared to the patients who had ACL reconstruction with the single-bundle technique.","other_id":"KR","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Male or female.\r\n\r\n          2. Body mass index (BMI), which corresponds to the ratio between weight in kilograms\r\n             (pounds) and height in m2 (square meters) between 18.5 and 24.99.\r\n\r\n          3. Anterior instability alone or associated with chondral lesions of up to 1cm or\r\n             associated with meniscal injuries that do not alter the postoperative rehabilitation.\r\n\r\n          4. Magnetic resonance imaging (MRI) confirming the ACL injury.\r\n\r\n          5. Aged between 20 and 45 years.\r\n\r\n          6. Not having asymmetric varus alignment, greater than or equal to 5 degrees (to\r\n             eliminate cases with indication for osteotomy of the tibia), using panoramic\r\n             radiographic comparison of the lower limbs in standing position.\r\n\r\n          7. Absence of associated ligament instabilities (medial, lateral or posterior).\r\n\r\n          8. No previous surgery on the affected knee.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. New post-surgical trauma after 12 months.\r\n\r\n          2. Interruption of treatment / follow-up.\r\n\r\n          3. Postoperative infection.\r\n      ","sponsor":"Vita Care","sponsor_type":"Other","conditions":"Anterior Cruciate Ligament Injury","interventions":[{"intervention_type":"Procedure","name":"Procedure: Single bundle anterior cruciate ligament reconstruction","description":"The surgical technique includes ACL reconstruction with graft of two autologous tendons - the semitendinous and gracilis - fixed in one tibial tunnel and one femoral tunnel. Once the graft is obtained, the arthroscopy-assisted ACL reconstruction is performed using anterolateral, anteromedial and accessory anteromedial portals. The first tunnel to be built is femoral tunnel, through a Smith & Nephew femoral guide inserted into the anteromedial portal in the 10:30 h position for the right knee and 1:30 h position for the left knee, with the knee at 120 of flexion. The next tunnel is tibial tunnel. The tunnel has its point of entry anterior to the fibers of the superficial medial collateral ligament, and the tibial guide must be adjusted at 45 degrees. The new ligament is fixed onto the tibia and femur with a biodegradable interference screw."},{"intervention_type":"Procedure","name":"Procedure: Double bundle anterior cruciate ligament reconstruction","description":"The ACL reconstruction is performed with graft of two autologous tendons -the semitendinous and gracilis- fixed in two tibial tunnels and two femoral tunnels. The first tunnel to be built is the anteromedial (AM) femoral tunnel, through femoral guide inserted into the AM portal in the 10:30 h position for the right knee and 1:30 h position for the left knee, with the knee at 120 of flexion. Then we drill the PL femoral tunnel in its anatomical position from the accessory AM portal, with the knee at 120 of flexion. The next tunnels are the PM and AM tunnels. The PL tunnel has its point of entry anterior to the fibers of the superficial medial collateral ligament, and the tibial guide must be adjusted at 45. The AM tunnel has its point of entry more lateral, and a bone bridge of at least one cm must be left between the tunnels, and the tibial guide adjusted at 55. Both bundles must be fixed onto the tibia and femur with a biodegradable interference screw."}],"outcomes":[{"outcome_type":"primary","measure":"Isokinetic testing","time_frame":"2 years","description":"Tests the muscle power and endurance"},{"outcome_type":"primary","measure":"Subjective and Objective IKDC Scores","time_frame":"2 years","description":"The subject will answer the subjective IKDC score and the investigator will complete the objective IKDC score"},{"outcome_type":"primary","measure":"Kinematic evaluation","time_frame":"2 years","description":"The subjects will perform 3 tasks. Walking with no change of direction. Walking with change of direction: walk straight until one foot will touch the force platform and at that moment the subject must change their direction of motion and make a 90° angle with respect to the original trajectory by rotating the body to the side of the foot that will touch the platform. Landing with change of direction: step down 4 steps of a stair as they touch the force platform in the ground, they change the direction of their motion so that the new trajectory will make a 90° angle with the former direction."}]}
{"nct_id":"NCT01338103","start_date":"2010-01-31","phase":"N/A","enrollment":10,"brief_title":"Treatment of Pemphigus Patients With Rituximab 1000mgX2 and Assessment of Immune Status Via Cylex","official_title":"Treatment of Moderate to Severe Patients With Pemphigus With the Monoclonal Anti CD20 Antibody Rituximab at a Protocol of 1000mgX2 and Assessment of Their Immune Status Via the Cylex Test","primary_completion_date":"2012-06-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2012-06-30","last_update":"2011-05-02","description":"The purpose of this study is to determine whether Rituximab, in the same doses as used in rheumatoid arthritis patients, will benefit pemphigus patients. It also tests immune function via the Cylex assay in pemphigus patients before and after treatment with RItuximab.","other_id":"5474","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        1. Pemphigus patients with moderate-severe disease\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Pregnancy or lactation\r\n\r\n          2. Woman of reproductive age not using birth control measures.\r\n\r\n          3. Prior severe allergy or anaphylaxis with a human monoclonal antibody\r\n\r\n          4. Heart failure\r\n\r\n          5. Unstable angina or ischemic heart disease\r\n\r\n          6. Uncontrolled arrhythmia\r\n\r\n          7. HIV positive\r\n\r\n          8. Active hepatitis B infection or positive for hepatitis C virus (HCV) antibodies.\r\n\r\n          9. Severe dementia or a psychiatric illness\r\n\r\n         10. Active acute infection\r\n      ","sponsor":"Rabin Medical Center","sponsor_type":"Other","conditions":"Pemphigus","interventions":[{"intervention_type":"Drug","name":"Drug: Rituximab","description":"intravenous (IV) Rituximab 1 gramX2, every (q) 2 weeks."}],"outcomes":[{"outcome_type":"primary","measure":"Complete or partial remission off treatment (based on the consensus statement for pemphigus)","time_frame":"6 months after treatment"}]}
{"nct_id":"NCT01358396","start_date":"2010-01-31","enrollment":52,"brief_title":"Glycemic Control and Diabetic Macular Edema","official_title":"The Effect of Glycemic Control on Visual and Anatomical Outcomes in Response to Therapy for Diabetic Macular Edema.","primary_completion_date":"2010-07-31","study_type":"Observational","rec_status":"Completed","completion_date":"2010-10-31","last_update":"2011-05-23","description":"Does diabetic patients' glycemic control affect their response to laser and/or intravitreal injection therapy in terms of visual and anatomical outcomes.","other_id":"HB-DME-1","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":20,"maximum_age":80,"population":"Diabetic patients with macular edema with central foveal thickness more than 250 microns\r\n        and no proliferative changes.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Central foveal thickness more than 250 microns\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Proliferative Diabetic Retinopathy.\r\n\r\n          -  Traction Macular Membranes\r\n\r\n          -  Previous Laser or intravitreal injections within 6 months.\r\n      ","sponsor":"Cairo University","sponsor_type":"Other","conditions":"Diabetic Macular Edema","interventions":[{"intervention_type":"Other","name":"Other: Respond to therapy for diabetic macular edema","description":"Correlate HBA1c with visual acuity outcome to therapy."}],"outcomes":[{"outcome_type":"primary","measure":"Visual Acuity","time_frame":"3 months","description":"Correlate baseline HBA1c to the visual outcomes."}]}
{"nct_id":"NCT01086306","start_date":"2010-01-31","enrollment":113505,"brief_title":"Risk of Hospitalized Infections Among Patients With Type 2 Diabetes Exposed to Oral Antidiabetic Treatment","official_title":"Comparison of Risk of Hospitalization for Infections Between Patients With Type 2 Diabetes Exposed to Saxagliptin and Those Exposed to Other Oral Anti-Diabetic Treatments","primary_completion_date":"2015-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2015-12-31","last_update":"2016-09-20","description":"The purpose of this study is to compare the incidence of hospitalizations for infections among patients with type 2 diabetes mellitus who are new initiators of Saxagliptin and those who are new initiators of Oral Anti-Diabetic Drug (OADs) in classes other than DPP4 inhibitors; and to compare the incidence of hospitalizations with infections associated with T-lymphocyte dysfunction (i.e., herpes zoster, tuberculosis, or non-tuberculous mycobacterial infections [evaluated as a composite outcome]) among patients with type 2 diabetes mellitus who are new initiators of Saxagliptin and those who are new initiators of OADs in classes other than DPP4 inhibitors.","other_id":"CV181-101","observational_model":"Cohort","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"This study will be carried out using databases containing administrative claims data\r\n        [HealthCore Integrated Research Database (HIRD) and Medicare in the U.S.] and electronic\r\n        medical records [General Practice Research Database (GPRD) and The Health Improvement\r\n        Network (THIN) in the UK]. The US population includes patients from health plans in the\r\n        northeast, southeastern, mid-Atlantic, central, mid-western, and western regions (HIRD) as\r\n        well as US citizens 65 years of age and older (Medicare). The UK population includes\r\n        patients seeking medical care from general practitioners (GPRD and THIN)","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18 years of age or older\r\n\r\n          -  Newly prescribed Saxagliptin [or an OAD in a class other than Dipeptidyl peptidase-4\r\n             (DPP4) inhibitors]\r\n\r\n          -  Enrolled in the respective database for at least 180 days prior to the first\r\n             prescription of new OAD\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients identified with a diagnostic code for inpatient diagnostic code for any of\r\n             the infections of interest within the 180-day baseline period\r\n\r\n          -  Patients with DPP4 inhibitor exposure during the baseline period\r\n\r\n          -  Patients currently using exenatide or insulin\r\n      ","sponsor":"AstraZeneca","sponsor_type":"Industry","conditions":"Diabetes Mellitus, Type 2","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"To compare the incidence of hospitalizations for infections among patients with type 2 Diabetes Mellitus who are new initiators of Saxagliptin and those who are new initiators of oral antidiabetic drug (OADs) in classes other than DPP4 inhibitors","time_frame":"18 months"},{"outcome_type":"primary","measure":"To compare the incidence of hospitalizations for infections among patients with type 2 Diabetes Mellitus who are new initiators of Saxagliptin and those who are new initiators of oral antidiabetic drug (OADs) in classes other than DPP4 inhibitors","time_frame":"36 months"},{"outcome_type":"primary","measure":"To compare the incidence of hospitalizations for infections among patients with type 2 Diabetes Mellitus who are new initiators of Saxagliptin and those who are new initiators of oral antidiabetic drug (OADs) in classes other than DPP4 inhibitors","time_frame":"54 months"},{"outcome_type":"primary","measure":"To compare the incidence of hospitalizations with infections associated with T Lymphocyte dysfunction","time_frame":"18 months","description":"To compare the incidence of hospitalizations with infections associated with T Lymphocyte dysfunction (i.e., herpes zoster, tuberculosis, or non-tuberculous mycobacterial infections[evaluated as a composite outcome]) among patients with type 2 Diabetes Mellitus who are new initiators of Saxagliptin and those who are new initiators of OADs in classes other than DPP4 inhibitors"},{"outcome_type":"primary","measure":"To compare the incidence of hospitalizations with infections associated with T Lymphocyte dysfunction","time_frame":"36 months","description":"To compare the incidence of hospitalizations with infections associated with T Lymphocyte dysfunction (i.e., herpes zoster, tuberculosis, or non-tuberculous mycobacterial infections[evaluated as a composite outcome]) among patients with type 2 Diabetes Mellitus who are new initiators of Saxagliptin and those who are new initiators of OADs in classes other than DPP4 inhibitors"},{"outcome_type":"primary","measure":"To compare the incidence of hospitalizations with infections associated with T Lymphocyte dysfunction","time_frame":"54 months","description":"To compare the incidence of hospitalizations with infections associated with T Lymphocyte dysfunction (i.e., herpes zoster, tuberculosis, or non-tuberculous mycobacterial infections[evaluated as a composite outcome]) among patients with type 2 Diabetes Mellitus who are new initiators of Saxagliptin and those who are new initiators of OADs in classes other than DPP4 inhibitors"},{"outcome_type":"secondary","measure":"A composite outcome of either inpatient or outpatient diagnoses of herpes zoster, tuberculosis, and non-tuberculous mycobacterial infections plus prescriptions for related antimicrobial therapies","time_frame":"18 months"},{"outcome_type":"secondary","measure":"A composite outcome of either inpatient or outpatient diagnoses of herpes zoster, tuberculosis, and non-tuberculous mycobacterial infections plus prescriptions for related antimicrobial therapies","time_frame":"36 months"},{"outcome_type":"secondary","measure":"A composite outcome of either inpatient or outpatient diagnoses of herpes zoster, tuberculosis, and non-tuberculous mycobacterial infections plus prescriptions for related antimicrobial therapies","time_frame":"54 months"},{"outcome_type":"secondary","measure":"Inpatient or outpatient diagnoses of herpes zoster, tuberculosis, or non-tuberculous mycobacterial infections (evaluated separately)","time_frame":"18 months"},{"outcome_type":"secondary","measure":"Inpatient or outpatient diagnoses of herpes zoster, tuberculosis, or non-tuberculous mycobacterial infections (evaluated separately)","time_frame":"36 months"},{"outcome_type":"secondary","measure":"Inpatient or outpatient diagnoses of herpes zoster, tuberculosis, or non-tuberculous mycobacterial infections (evaluated separately)","time_frame":"54 months"},{"outcome_type":"secondary","measure":"Inpatient diagnoses of respiratory tract infections","time_frame":"18 months"},{"outcome_type":"secondary","measure":"Inpatient diagnoses of respiratory tract infections","time_frame":"36 months"},{"outcome_type":"secondary","measure":"Inpatient diagnoses of respiratory tract infections","time_frame":"54 months"}]}
{"nct_id":"NCT03015935","start_date":"2010-01-31","enrollment":500,"brief_title":"Safe and Easy Access Technique for the First Trocar in Laparoscopic Obesity Surgery","official_title":"Safe and Easy Access Technique for the First Trocar in Laparoscopic Obesity Surgery. A Prospective Controlled-cohort Study","primary_completion_date":"2018-01-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2018-05-31","last_update":"2017-01-16","description":"Laparoscopic surgery has become very popular and standard in many indications after advancements of technique. Various methods have been used in first entry to the abdomen. Safety, wound size, to be not time-consuming, low cost, learning curve and efficacy are important. Several techniques, instruments, and approaches to minimize the risk of injury (the bowel, bladder, major abdominal vessels, and an anterior abdominal wall vessel) have been introduced. There is no consensus yet on an optimal method has yet emerged. The investigators aimed to evaluate efficacy of entry methods that ensures safe insertion of the first trocar at any site of the abdomen. To evaluate the efficacy of entry technique, the investigators used cohort of patients who will be planned to laparoscopic obesity surgery. Two methods are commonly used in surgical literature and in our center. The investigators have been used visible optical-entry technique in some patients for first entry and Veress technique in some other patients. For this purpose, the investigators designed an observational study.","other_id":"First_Trocar_Entery","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":70,"population":"Patients who are eligible for laparoscopic obesity surgery","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with body mass index of >40\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who have skin disease at operation area\r\n      ","sponsor":"Umraniye Education and Research Hospital","sponsor_type":"Other","conditions":"Obesity, Morbid","interventions":[{"intervention_type":"Procedure","name":"Procedure: visual-assisted entry","description":"First trocar entry will be performed with visual-assisted trocar"},{"intervention_type":"Procedure","name":"Procedure: Veress entry","description":"First trocar entry will be performed with Veress"}],"outcomes":[{"outcome_type":"primary","measure":"Entry time","time_frame":"intraoperative"}]}
{"nct_id":"NCT01096719","start_date":"2010-01-31","phase":"N/A","enrollment":45,"brief_title":"The Healthy Eating Choices for Life Program","official_title":"The Effect of Diets Targeting Energy Density and Energy Restriction on Weight Loss and Feelings of Deprivation, Satisfaction, and Hunger During Behavioral Weight Loss Treatment.","primary_completion_date":"2010-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-08-31","last_update":"2018-04-05","description":"The purpose of this investigation is to conduct a 12-week pilot study to examine the effect of three different dietary prescriptions that differ on targeting reducing energy density (kcal/gram) and energy (kcal) on overall dietary intake, hunger, feelings of deprivation, satisfaction with the diet, mood, and weight loss in 45 overweight/obese adults receiving a 12-week behavioral weight loss intervention.","other_id":"IRB 8107 B","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":21,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age between 21 and 65 years\r\n\r\n          -  Body mass index (BMI) between 25 and 45 kg/m2\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Report a health condition on the Physical Activity Readiness Questionnaire (PAR-Q)\r\n\r\n          -  Report being unable to walk for 2 blocks (1/4 mile) without stopping\r\n\r\n          -  Report major psychiatric diseases/organic brain syndromes via a phone screen\r\n\r\n          -  Are currently participating in a weight loss program and/or taking weight loss\r\n             medication or lost > 5% of body weight during the past 6 months\r\n\r\n          -  Intend to move to another city within the time frame of the investigation\r\n\r\n          -  Are pregnant, lactating, less than 6 months post-partum, or plan to become pregnant\r\n             during the time frame of the investigation\r\n\r\n          -  Have had gastric surgery for weight loss\r\n      ","sponsor":"The University of Tennessee, Knoxville","sponsor_type":"Other","conditions":"Obesity","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Standard Behavioral Weight Loss Intervention","description":"12 week standard behavioral weight loss intervention including a physical activity goal and behavioral weight control strategies"},{"intervention_type":"Behavioral","name":"Behavioral: Dietary Goal: Reduction in Energy Density of Dietary Intake","description":"Consume low ED foods (ED < 1.0) for at least 10 items consumed per day and limit high ED foods (ED > 3.0) to two items consumed per day."},{"intervention_type":"Behavioral","name":"Behavioral: Dietary Goal: Reduction of Energy Intake","description":"Limit energy intake to 1200 to 1500 kcals/day and < 30% kcals from fat."}],"outcomes":[{"outcome_type":"primary","measure":"Energy density of the diet","time_frame":"Weeks 0 and 13","description":"Energy density is defined as the kilocalories per gram of a food. Energy density will be measured by collecting and analyzing 3-day food records using Nutrition Data Systems for Research at baseline (week 0) and post intervention (week 13)."},{"outcome_type":"secondary","measure":"Weight Loss","time_frame":"Weeks 0 and 13"},{"outcome_type":"secondary","measure":"Feelings of dietary deprivation and satisfaction","time_frame":"Weeks 0 and 13","description":"Dietary deprivation and satisfaction will be measures using 100mm visual analog scales with the statements \"I feel like I ate enough today\" and \"I feel like I ate what I wanted today\". Both scales are anchored with \"strongly disagree\" on one end and \"strongly agree\" on the other end. These will be collected for 7 days at baseline (week 0) and post intervention (week 13)."},{"outcome_type":"secondary","measure":"Hunger","time_frame":"Weeks 0 and 13","description":"Hunger will be measured using a 100mm visual analog scale. The scale asks \"How hungry did you feel today?\" and is anchored with \"not at all hungry\" on one end and \"extremely hungry\" on the other. Hunger scales will be collected for 7 days at baseline (week 0) and post intervention (week 13)."}]}
{"nct_id":"NCT04079127","start_date":"2010-01-09","enrollment":150,"brief_title":"Avenir Mller Hip Stem Post Market Surveillance Study","official_title":"A Multi-centre, Non-comparative, Retrospective Post-market Surveillance Study to Obtain Clinical Outcomes Data on the Zimmer Avenir Mller Hip Stem","primary_completion_date":"2019-06-29","study_type":"Observational","rec_status":"Completed","completion_date":"2019-08-31","last_update":"2021-05-14","description":"This study is a Post Market Clinical Follow up study to fulfil the post market surveillance obligations according to Medical Device Directive and European Medical Device Vigilance System (MEDDEV) 2.12-2. The data collected from this study will serve the purpose of confirming safety and performance of the Avenir Mller Hip Stem.","other_id":"09H08","observational_model":"Cohort","time_perspective":"Other","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"Patients suffering from severe hip pain and disability requiring a total hip arthroplasty.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients able to participate in a follow-up program based upon physical examination\r\n             and medical history.\r\n\r\n          -  Patients or patient's legal representatives who have given written consent to take\r\n             part in the study by signing the 'Patient Consent Form'.\r\n\r\n          -  18 years minimum.\r\n\r\n          -  Male and female.\r\n\r\n          -  Baseline data exist (pre-, peri- and immediate postoperative)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who are unwilling or unable to comply with the follow-up program.\r\n\r\n          -  Known pregnancy.\r\n\r\n          -  Patients who are skeletally immature.\r\n      ","sponsor":"Zimmer Biomet","sponsor_type":"Industry","conditions":"Osteoarthritis, Hip|Rheumatoid Arthritis|Fracture of Hip|Dislocated Hip|Osteonecrosis|Post-traumatic; Arthrosis|Subluxation Hip","interventions":[{"intervention_type":"Device","name":"Device: Patients who met the inclusion/exclusion criteria to receive the Avenir Mller stem.","description":"Consecutive cohort of patients enrolled at every site who received the Avenir Mller stem."}],"outcomes":[{"outcome_type":"secondary","measure":"Confirmation of Safety Based on Complications","time_frame":"up to 10 years","description":"Number of patients with adverse events related to the implant will be reported. Adverse events include: dislocations of the hip, revisions and removals of the implant components.\r\nHere, the entire cohort of patients (and hips) enrolled in the study were considered and are reported as the complications occured from the early stages of the study, and up to 10 year post surgery, and could occur to any patients."},{"outcome_type":"primary","measure":"Evaluation of Pain and Functional Performance Determined by the Harris Hip Score","time_frame":"10 years","description":"The Harris Hip Score is a questionnaire filled by the surgeon with the patient who received a hip implant. The domains covered are pain, function, absence of deformity, and range of motion. The pain domain measures pain severity and its effect on activities and need for pain medication.\r\nThe function domain consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction.\r\nThere are 10 items. The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points)."},{"outcome_type":"secondary","measure":"Survivorship of the Implant","time_frame":"10 years","description":"Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method.\r\nHere, the entire cohort of patients (and hips) enrolled in the study were considered and are reported as the revisions could happen from the early stages of the study, and up to 10 year post surgery, and could occur to any patients. Even if a patient did not come back for a visit, the information if the implant was still in place was provided and taken into account for the survival analysis (gives higher numbers than for the clinical evaluation)."}]}
{"nct_id":"NCT01289756","start_date":"2009-12-31","phase":"Phase 1","enrollment":20,"brief_title":"Influence of Pharmacogenetic Factors, Paroxetine and Clarithromycin on Pharmacokinetics of Clomiphene","official_title":"Influence of Pharmacogenetic Factors, Paroxetine and Clarithromycin on Pharmacokinetics of Clomiphene","primary_completion_date":"2014-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-11-30","last_update":"2015-02-24","description":"Aim of the study is the clinical validation of the metabolism and the pharmakokinetic of Clomifen in correlation to CYP2D6 and inhibition of CYP3A4.","other_id":"IKP237","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy\r\n\r\n          -  Female caucasians\r\n\r\n          -  Age 18 - 45 years old\r\n\r\n          -  BMI 18.5 - 26 kg/m2\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Persons with known sensitivity of Clomifen and/or Paroxetine and/or Clarithromycin\r\n\r\n          -  Pregnancy/lactation period\r\n\r\n          -  Meno-/postmenopausal\r\n\r\n          -  Smokers\r\n      ","sponsor":"Robert Bosch Gesellschaft fr Medizinische Forschung mbH","sponsor_type":"Other","conditions":"Anovulation|Disorder Due Cytochrome P450 CYP2D6 Variant|Cytochrome P450 CYP3A Enzyme Deficiency","interventions":[{"intervention_type":"Drug","name":"Drug: Clomiphene","description":"clomiphene once 100 mg oral"},{"intervention_type":"Drug","name":"Drug: clomiphene and paroxetine","description":"clomiphene 100mg and paroxetine 3x40mg"},{"intervention_type":"Drug","name":"Drug: clomiphene and clarithromycin","description":"clomiphene 100mg and clarithromycin 9x500mg"}],"outcomes":[{"outcome_type":"secondary","measure":"Tmax of clomiphene","time_frame":"4, 8, 12, 24 hours after drug application","description":"Tmax of clomiphene and metabolites"},{"outcome_type":"secondary","measure":"Pharmacogenomics","time_frame":"once","description":"Pharmacogenomics"},{"outcome_type":"secondary","measure":"Clearance of Clomiphene","time_frame":"4, 8, 12 and 24 hours after drug application","description":"Clearance of Clomiphene and metabolites"},{"outcome_type":"secondary","measure":"Metabolomic","time_frame":"4, 8, 12 and 24 hours after drug application","description":"Metabolomic"},{"outcome_type":"primary","measure":"Area under the plasma concentration versus time curve (AUC)of clomiphene","time_frame":"1, 2, 4, 6, 8, 10, 12, 24, 72 and 168 hours after durg application","description":"AUC of clomiphene and metabolites"},{"outcome_type":"primary","measure":"Peak Plasma Concentration (Cmax)of Clomiphene","time_frame":"1, 2, 4, 6, 8, 10, 12, 24, 72 and 168 hours after drug application","description":"Cmax of Clomiphene and metabolites"}]}
{"nct_id":"NCT01050595","start_date":"2009-12-31","phase":"Phase 3","enrollment":80,"brief_title":"Methylnaltrexone for Treatment of Opiate-Induced Constipation in the Intensive Care Unit","official_title":"Methylnaltrexone for the Reversal of Opiate-Induced Constipation in the Intensive Care Unit","primary_completion_date":"2010-10-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2010-12-31","last_update":"2010-01-15","description":"The purpose of this study is to determine if there will be a significantly higher incidence of a bowel movement with methylnaltrexone vs. placebo within 4 hours +- 45 minutes with decreased need for rescue medications in the intensive care unit in patients with opioid-induced constipation. Patients will also be managed with an aggressive bowel management protocol.","other_id":"107199","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18 years of age or older in the ICU\r\n\r\n          -  Opioids for analgesia for at least 24 hours.\r\n\r\n          -  Opioid-induced constipation with no bowel movement within the last 72 hours.\r\n\r\n          -  Women of childbearing potential had negative pregnancy tests.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Contraindication to use of the GI tract\r\n\r\n          -  Diarrhea on admission\r\n\r\n          -  Bowel surgery within 8 weeks of admission\r\n\r\n          -  Ileostomy or colostomy\r\n\r\n          -  Not expected to live or stay more than 3 days in the intensive care unit\r\n\r\n          -  Constipation that was not primarily caused by opioids (as determined by the\r\n             investigator)\r\n\r\n          -  No opioid use in the last 24 hours,\r\n\r\n          -  Mechanical gastrointestinal obstruction\r\n\r\n          -  An indwelling peritoneal catheter\r\n\r\n          -  Clinically active diverticular disease\r\n\r\n          -  Fecal impaction\r\n\r\n          -  Acute surgical abdomen\r\n\r\n          -  History of Crohn's disease or ulcerative colitis\r\n\r\n          -  On Palliative care\r\n\r\n          -  Less than 18 years old\r\n\r\n          -  Bowel movement in last 72 hours.\r\n      ","sponsor":"St. John Health System, Michigan","sponsor_type":"Other","conditions":"Opioid-induced Constipation","interventions":[{"intervention_type":"Drug","name":"Drug: Methylnaltrexone Bromide","description":"The experimental group will receive the recommended dose of MNTX (Relistor) is 8 mg for patients weighing 38 kg to less than 62 kg (84 lbs to less than 136 lbs) or 12 mg for patients weighing 62 kg to 114 kg (136 lbs to 251 lbs). Patients whose weight is below 38 kg or greater than 114 kg, will be dosed at 0.15 mg/kg. If creatinine clearance <30 will decrease dose by 50%. This will be given after 72 hours of no bowel movement. Bowel management protocol will be instituted four hours afterward with the methylnaltrexone being given every other day."},{"intervention_type":"Drug","name":"Drug: Placebo-Normal Saline","description":"Control group will be given an equal amount of normal saline in an identically appearing vial every other day until a bowel movement occurs. A bowel management protocol will also be started."}],"outcomes":[{"outcome_type":"primary","measure":"A significantly higher incidence of a rescue free laxation with methylnaltrexone within 4 hours +- 45 minutes.","time_frame":"Nine months"},{"outcome_type":"secondary","measure":"Decreased need for rescue medications to have a bowel movement in the treatment arm vs placebo.","time_frame":"Nine months"}]}
{"nct_id":"NCT01001091","start_date":"2009-12-31","phase":"Phase 2","enrollment":312,"brief_title":"AL-38583 Ophthalmic Solution for Allergic Conjunctivitis Associated Inflammation","primary_completion_date":"2010-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-04-30","last_update":"2014-07-17","description":"The purpose of this study is to assess the safety and efficacy of AL-38583 in the treatment of the signs of inflammation associated with allergic conjunctivitis.","other_id":"C-09-034","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Presence of signs and symptoms of ocular inflammation in both eyes.\r\n\r\n          -  Have a positive CAC response at Visit 1.\r\n\r\n          -  Able to avoid the use of disallowed medications as well as contact lens wear for the\r\n             specified period prior to Visit 1, and for the duration of the study.\r\n\r\n          -  Other protocol-defined inclusion criteria may apply.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Have known history or presence of persistent dry eye syndrome.\r\n\r\n          -  Presence of any ophthalmic abnormality that may affect the study outcomes.\r\n\r\n          -  Have a history of moderate to severe allergic asthma reaction to mountain cedar or the\r\n             perennial allergens used in the study.\r\n\r\n          -  Other protocol-defined exclusion criteria may apply.\r\n      ","sponsor":"Alcon Research","sponsor_type":"Industry","conditions":"Allergic Conjunctivitis","interventions":[{"intervention_type":"Drug","name":"Drug: AL-38583 ophthalmic solution"},{"intervention_type":"Drug","name":"Drug: AL-38583 ophthalmic solution vehicle","description":"Inactive ingredients used as a placebo comparator"},{"intervention_type":"Drug","name":"Drug: Dexamethasone ophthalmic suspension, 0.1%"}],"outcomes":[{"outcome_type":"primary","measure":"Mean area under the curve 0-7 hours post-CAC for conjunctival redness scores","time_frame":"Day 14"},{"outcome_type":"secondary","measure":"Mean daily diary ocular redness scores","time_frame":"2 week period between Day 0 and Day 14"}]}
{"nct_id":"NCT01083797","start_date":"2009-12-31","phase":"Phase 3","enrollment":25,"brief_title":"Sedation to Electroencephalography With Dexmedetomidine or Chloral Hydrate","official_title":"Sedation to Electroencephalography With Dexmedetomidine or Chloral Hydrate: a Comparative Study of the Qualitative and Quantitative Electroencephalogram Pattern","primary_completion_date":"2013-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-10-31","last_update":"2013-10-25","description":"This study evaluates the use of dexmedetomidine or chloral hydrate for sedation during electroencephalography in patients with neurological disorders. The hypothesis is that this drugs provides similar changes in EEG pattern.","other_id":"CEP 106/2009","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":12,"maximum_age":38,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  neurological disorder\r\n\r\n          -  behavior disorder\r\n\r\n          -  epilepsy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  cardiac disease\r\n\r\n          -  respiratory disease\r\n      ","sponsor":"Federal University of Minas Gerais","sponsor_type":"Other","conditions":"Other Conditions of Brain","interventions":[{"intervention_type":"Drug","name":"Drug: Dexmedetomidine","description":"1 g kg-1 infused in 10 min, and thereafter maintained from 0.2 to 0.7 g kg-1 h- 1"},{"intervention_type":"Drug","name":"Drug: Chloral Hydrate","description":"Initial dose=50 mg/kg"}],"outcomes":[{"outcome_type":"primary","measure":"electroencephalogram pattern","time_frame":"twenty minutes","description":"Qualitative analysis: identification of the deepest phase of sleep achieved during the examination, evaluation of background activity (normal, fast activity increased or slow activity increased).\r\nQuantitative analysis: density, duration, and amplitude of sleep spindles, spectral power and dominant frequence."},{"outcome_type":"secondary","measure":"Effective sedative","time_frame":"twenty minutes","description":"Maintain adequate sedation permitting the completion of the examination"},{"outcome_type":"secondary","measure":"Adverse effects","time_frame":"Two hours","description":"Incidence of bradycardia, hypotension, respiratory complications and vomiting"}]}
{"nct_id":"NCT01035671","start_date":"2009-12-31","phase":"Phase 2","enrollment":42,"brief_title":"Safety and Efficacy Study of A0001 in Subjects With Friedreich's Ataxia","official_title":"A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, 28 Day, Three-arm, Parallel Group Study of A0001 in the Treatment of Subjects With Friedreich's Ataxia","primary_completion_date":"2011-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-03-31","last_update":"2011-04-22","description":"This is a Phase 2a double-blind, placebo-controlled study with two dose levels of A0001 given twice daily for 28 days. Potential subjects will be screened first to determine eligibility, after which they will be randomized to receive either a high dose of A0001, a low dose of A0001 or placebo for 28 days. Eligible subjects will return within 21 days of screening for the baseline visit and randomization to one of three potential treatments. The subjects will be required to take 3 capsules of study medication in the morning with a morning meal and 3 capsules of study medication at night with an evening meal for 28 days. Additional visits to the clinic are planned for Day 14 and Day 28, at which time a number of clinical and biochemical assessments will be done.","other_id":"FRD02","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Individuals with genetically confirmed Friedreich's Ataxia (GAA or point mutation)\r\n\r\n          -  Impaired Glucose Tolerance, measured by Oral GTT\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Overt Diabetes Mellitus\r\n\r\n          -  Presence of clinically significant cardiovascular disease\r\n      ","sponsor":"Penwest Pharmaceuticals Co.","sponsor_type":"Industry","conditions":"Friedreich's Ataxia","interventions":[{"intervention_type":"Drug","name":"Drug: alpha-tocopherolquinone (A0001)","description":"28 days of low dose (1.0 g total daily dose) oral A0001 capsules. Treatment taken twice daily with meals."},{"intervention_type":"Drug","name":"Drug: alpha-tocopherolquinone (A0001)","description":"28 days of high dose (1.5 g total daily dose) oral A0001 capsules. Treatment taken twice daily with meals."},{"intervention_type":"Drug","name":"Drug: placebo","description":"28 days of placebo oral capsules. Treatment taken twice daily with meals."}],"outcomes":[{"outcome_type":"secondary","measure":"HbA1C","time_frame":"Baseline, Day 14 and Day 28"},{"outcome_type":"secondary","measure":"Timed 25 Foot Walk Test","time_frame":"Baseline and Day 28"},{"outcome_type":"secondary","measure":"FARS/neurological exam","time_frame":"Baseline and Day 28"},{"outcome_type":"secondary","measure":"9-Hole Peg Test","time_frame":"Baseline, Day 14 and Day 28"},{"outcome_type":"secondary","measure":"Vision Low Contrast Letter Acuity Test","time_frame":"Baseline and Day 28"},{"outcome_type":"secondary","measure":"Global Impression of Clinical Severity","time_frame":"Baseline, Day 14 and Day 28"},{"outcome_type":"secondary","measure":"Modified Fatigue Impact Scale","time_frame":"Baseline and Day 28"},{"outcome_type":"secondary","measure":"Glucose effectiveness (SG) calculated from IVGTT","time_frame":"Baseline, Day 14 and Day 28"},{"outcome_type":"secondary","measure":"AIRg for glucose and insulin during IVGTT","time_frame":"Baseline, Day 14 and Day 28"},{"outcome_type":"secondary","measure":"Fasting Glucose, Insulin and Lactate","time_frame":"Baseline, Day 14 and Day 28"},{"outcome_type":"secondary","measure":"Activities of Daily Living","time_frame":"Baseline and Day 28"},{"outcome_type":"secondary","measure":"SF-36®","time_frame":"Baseline and Day 28"},{"outcome_type":"primary","measure":"Change in Disposition Index of Glucose Regulation, determined by Frequent Sampling IV Glucose Tolerance Test","time_frame":"Baseline, Day 14 and Day 28"},{"outcome_type":"secondary","measure":"Sensitivity index (SI) calculated from IVGTT","time_frame":"Baseline, Day 14 and Day 28"},{"outcome_type":"secondary","measure":"Plasma 1,5-anhydroglucitol (1,5-AG) (Glycomark)","time_frame":"Baseline, Day 14 and Day28"},{"outcome_type":"secondary","measure":"Specific Activity of Complex 1 in whole blood","time_frame":"Baseline, Day 14 and Day 28"}]}
{"nct_id":"NCT01044758","start_date":"2009-12-31","phase":"Phase 2","enrollment":96,"brief_title":"Levetiracetam and Memory Function in Amnestic Mild Cognitive Impairment (MCI)","official_title":"Bridging Cognitive Aging in Rodents to Man Using fMRI in Amnestic MCI","primary_completion_date":"2012-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-07-31","last_update":"2017-08-21","description":"This research is being done to find out if daily use of the drug levetiracetam can improve memory function in individuals with memory problems like those associated with Mild Cognitive Impairment (MCI) and Alzheimer's disease (AD).","other_id":"NA_00030573","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Basic Science","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":50,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  All: English as a first language; right handed; able to complete written informed\r\n             consent.\r\n\r\n          -  MCI subjects: In addition to above, must meet criteria for amnestic Mild Cognitive\r\n             Impairment (MCI). This includes a memory complaint corroborated by an informant;\r\n             impaired memory function for age and educational level; preserved general cognitive\r\n             function; intact abilities of daily living; no clinical dementia.\r\n\r\n          -  Age matched Controls: Must have memory and cognitive status that is normal for their\r\n             age.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Familial Alzheimer's Disease (AD) due to known genetic mutations\r\n\r\n          -  AD with Parkinsonian features; major psychiatric or behavioral disorders (e.g.\r\n             depression, agitation, psychosis, manic-depressive disorder)\r\n\r\n          -  Primary or metastatic intracranial neoplasm\r\n\r\n          -  History of severe head trauma\r\n\r\n          -  Intra-cerebral hemorrhage\r\n\r\n          -  Seizure disorder\r\n\r\n          -  Hemispheric stroke\r\n\r\n          -  Presence of a progressive central nervous system disease\r\n\r\n          -  Presence of lacunar infarcts\r\n\r\n          -  Medical contraindications to MRI including cardiac pacemaker, presence of intraocular\r\n             or intracranial metallic objects\r\n\r\n          -  Any known allergy to levetiracetam or behavioral problems that are a contraindication\r\n             to taking Levetiracetam (e.g. agitation)\r\n\r\n          -  Prescribed use of anti-seizure medications.\r\n      ","sponsor":"Johns Hopkins University","sponsor_type":"Other","conditions":"Mild Cognitive Impairment (MCI)","interventions":[{"intervention_type":"Drug","name":"Drug: Levetiracetam 250mg","description":"250mg twice daily (2 weeks)"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"placebo capsule twice daily (2 weeks)"},{"intervention_type":"Drug","name":"Drug: Levetiracetam 62.5mg","description":"62.5mg twice daily (2 weeks)"},{"intervention_type":"Drug","name":"Drug: Levetiracetam 125mg","description":"125mg twice daily (2 weeks)"}],"outcomes":[{"outcome_type":"primary","measure":"Brain Activity in the Dentate Gyrus / CA3 Subregion of the Hippocampus Measured With Blood Oxygenation Level Dependent (BOLD) Functional MRI","time_frame":"2 weeks","description":"Measurement of average brain activity in the dentate gyrus / CA3 subregion of the hippocampus measured with BOLD functional MRI in patients with mild cognitive impairment on placebo and on drug compared to average brain activity in this brain area in control subjects."},{"outcome_type":"secondary","measure":"Behavioral Performance as Assessed in the Functional Magnetic Resonance Imaging (fMRI) Memory Task","time_frame":"2 weeks","description":"Mnemonic similarity task which assesses long term memory function. Scale ranges from 0-100 with higher scores indicating better memory performance."}]}
{"nct_id":"NCT01002924","start_date":"2009-12-31","phase":"Phase 2","enrollment":1,"brief_title":"Extension Study of EC145 (Vintafolide) for Subjects Enrolled in a Previous Study With EC145 (MK-8109-010)","official_title":"Protocol EC-FV-05: An Open-label, Multi-center, Extension Study of EC145 Administered Weeks 1 and 3 of a 4-Week Cycle in Subjects Enrolled in a Previous Study With EC145","primary_completion_date":"2013-12-11","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-12-11","last_update":"2021-04-08","description":"This extension protocol is for those subjects that have completed the allowed duration of participation in an Endocyte-sponsored clinical trial of EC145 (vintafolide) and have continuing evidence of clinical benefit (stable disease or better) at the time that they completed participation in that study.","other_id":"8109-010","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Must have received prior treatment with EC145 within the context of an\r\n             Endocyte-sponsored, IRB-approved clinical trial.\r\n\r\n          -  Disease (i.e., cancer) that was considered \"stable\" at the last evaluation while\r\n             participating in the previous EC145-containing study. \"Stable\" is defined as not\r\n             having progression of disease per standard criteria (RECIST, etc). Stable disease may\r\n             be indicated by previously attained complete or partial tumor shrinkage that has not\r\n             progressed per standard criteria.\r\n\r\n          -  No more than 10 weeks have elapsed since the last evaluation of \"stable disease\".\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\r\n\r\n          -  Must have recovered (to baseline/stabilization) from prior EC145-associated acute\r\n             toxicities.\r\n\r\n          -  Adequate bone marrow reserve, hepatic, and renal function.\r\n\r\n          -  Negative serum pregnancy test for women of childbearing potential\r\n\r\n          -  Willingness to practice contraceptive methods for men and women of childbearing\r\n             potential.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnancy.\r\n\r\n          -  Development of a secondary malignancy requiring treatment.\r\n\r\n          -  Symptomatic central nervous system (CNS) metastasis.\r\n\r\n          -  History of receiving any investigational treatment or other systemic therapy directed\r\n             at controlling cancer since the subject's last dose on the parent EC145 study.\r\n      ","sponsor":"Endocyte","sponsor_type":"Industry","conditions":"Solid Tumors","interventions":[{"intervention_type":"Drug","name":"Drug: EC145","description":"EC145 will be administered intravenously at a dose of 2.5 mg. Dosing will occur on Monday, Wednesday, and Friday of weeks 1 and 3 of each 4-week cycle. No therapy will be administered during weeks 2 and 4."}],"outcomes":[{"outcome_type":"primary","measure":"Number of participants experiencing adverse events","time_frame":"Up to 2 years"},{"outcome_type":"primary","measure":"Number of participants experiencing serious adverse events","time_frame":"Up to 2 years"},{"outcome_type":"primary","measure":"Number of participants discontinuing study drug due to adverse events","time_frame":"Up to 2 years"}]}
{"nct_id":"NCT01160419","start_date":"2009-12-31","phase":"Phase 2","enrollment":49,"brief_title":"Multicenter Study to Perioperative Chemotherapy for Resectable Adenocarcinoma in Gastric Cancer","primary_completion_date":"2011-05-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2014-05-31","last_update":"2010-10-28","description":"The rationale of the NEO-FLOT-trial consists of an intensification of the neoadjuvant treatment. This strategy is based upon the clear advantage of perioperative treatment and the fact, that in former trials adjuvant treatment could only be given in half of the patients (Cunningham 2006, Boige 2007). In this study neoadjuvant chemotherapy is applied during a period of 12 weeks with an interim staging after 6 weeks.Due to the favourable efficacy and toxicity data the FLOT-regimen was chosen for the neoadjuvant treatment consisting of oxaliplatin, docetaxel, folinic acid and 5-Fluorouracil (Al-Batran 2008). Postoperative treatment according to the results of the MAGIC trail is not part of the trail and is given at the responsibility of the participating centres.","other_id":"NEO-FLOT","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically Confirmed Adenocarcinoma of the Gastroesophageal Junction (AEG I-III)\r\n             or Gastric Adenocarcinoma (every T, N+ or T3/T4, Nx, M0)\r\n\r\n          -  Written Informed Consent\r\n\r\n          -  Age  18 Years\r\n\r\n          -  Expected operability\r\n\r\n          -  ECOG  2\r\n\r\n          -  Exclusion of Peritoneal Metastasis\r\n\r\n          -  Adequate Hematological, Renal, Cardiac and Hepatic Function\r\n\r\n          -  Effective Contraception\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior Chemotherapy or Radiotherapy of the Adenocarcinoma of the Gastroesophageal\r\n             Junction (AEG I-III) or Gastric Adenocarcinoma\r\n\r\n          -  Not Histologically Confirmed Primary Tumor\r\n\r\n          -  Distant Metastasis, Local Relapse\r\n\r\n          -  Known Hypersensitivity for 5-Fluorouracil, Leucovorin, Oxaliplatin or Docetaxel\r\n\r\n          -  Known Dihydropyrimidin-Dehydrogenase (DPD) - Deficiency\r\n\r\n          -  Peripheral Polyneuropathy  Grade II (NCI-CTCAE, Version 3.0)\r\n\r\n          -  Myocardial Infarction in the last 3 Months, Cardiac Insufficiency Grade II-IV (NYHA)\r\n\r\n          -  Severe Comorbidity or Acute Infections\r\n\r\n          -  Pregnancy or Breast Feeding\r\n\r\n          -  Insufficient Contraception\r\n\r\n          -  Participation in another Clinical Trial (Simultaneously or 30 Days Prior to\r\n             Enrollment)\r\n\r\n          -  Malignancy <5 years (except: Carcinoma In Situ of the Cervix Uteri or Adequately\r\n             Treated Basalioma of the Skin)\r\n\r\n          -  Lack of Legal Capacity\r\n      ","sponsor":"Ludwig-Maximilians - University of Munich","sponsor_type":"Other","conditions":"Gastric Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Docetaxel 50 mg/m2, 1-hour-Infusion, day 1","description":"50 mg/m2, 1-hour-Infusion, day 1"},{"intervention_type":"Drug","name":"Drug: Oxaliplatin 85 mg/m, 2-hour-Infusion, day 1","description":"85 mg/m, 2-hour-Infusion, day 1"},{"intervention_type":"Drug","name":"Drug: Folinic acid 200 mg/m, 1-2-hour-Infusion, day 1","description":"200 mg/m, 1-2-hour-Infusion, day 1"},{"intervention_type":"Drug","name":"Drug: 5-FU 2600 mg/m, 24-hour-Infusion, day 1","description":"2600 mg/m, 24-hour-Infusion, day 1"}],"outcomes":[{"outcome_type":"primary","measure":"Collection of the R0-Resection rate","time_frame":"12 weeks","description":"after 6 cycles of biweekly FLOT chemotherapy and operation."}]}
{"nct_id":"NCT01017991","start_date":"2009-12-31","phase":"N/A","enrollment":65,"brief_title":"Feeding Intervention for Infants With Crying","official_title":"Effects of an Infant Formula With Probiotics on Signs and Symptoms of \"Colic\".","primary_completion_date":"2012-08-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2013-03-31","last_update":"2017-11-17","description":"The purpose of the study is to assess if infants who have excessive crying and fussing have less of these symptoms when fed a formula containing a probiotic compared to those fed a standard infant formula.","other_id":"09.03.INF","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"Quadruple","sampling_method":"","gender":"All","maximum_age":0.33333,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  full term infants greater than or equal to 37 wks gestation\r\n\r\n          -  3 weeks to less than or equal to 4 months of age upon enrollment\r\n\r\n          -  experiencing ongoing crying and fussy episodes of a minimum of 3 hours of crying /day\r\n             for 3 days in a week for at least one week prior to enrollment\r\n\r\n          -  otherwise healthy as reported by parent/caregiver\r\n\r\n          -  is under the care of a pediatrician or other qualified healthcare professional and has\r\n             had at least one postnatal visit\r\n\r\n          -  taking no more than one feeding of breast milk per day\r\n\r\n          -  having not initiated weaning foods or beverages other than infant formula or breast\r\n             milk\r\n\r\n          -  study explained and written information provided with Parent/caregiver demonstrating\r\n             understanding of the given information\r\n\r\n          -  informed consent signed(parent/legal representative)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Chromosomal or major congenital anomalies\r\n\r\n          -  known cow's milk allergy\r\n\r\n          -  receiving any type of therapeutic formula (including extensively hydrolyzed formula or\r\n             free amino acid formula)\r\n\r\n          -  receiving an antibiotic or probiotic in the week prior to enrollment\r\n\r\n          -  complicated reflux, defined by reflux combined with inadequate growth and/or\r\n             respiratory complications\r\n\r\n          -  infant's family, who in the investigator's assessment, cannot be expected to comply\r\n             with the protocol\r\n\r\n          -  infant currently participating in another conflicting clinical study\r\n      ","sponsor":"Nestl","sponsor_type":"Industry","conditions":"Crying","interventions":[{"intervention_type":"Other","name":"Other: Milk based infant formula with probiotic","description":"formula supplied as a powder to be constituted as commercially available formula ad libitum daily 28 days duration"},{"intervention_type":"Other","name":"Other: Milk based infant formula","description":"supplied as a powder to be constituted as commercially available formula ad libitum daily 28 days"}],"outcomes":[{"outcome_type":"secondary","measure":"Formula intake","time_frame":"4 days"},{"outcome_type":"secondary","measure":"Tolerance evaluated by stool, vomiting, spitting and flatulence frequencies","time_frame":"4 days"},{"outcome_type":"primary","measure":"daily total crying time","time_frame":"28 days"}]}
{"nct_id":"NCT01206712","start_date":"2009-11-30","enrollment":106,"brief_title":"Beta Cell Relieving and Cardiovascular Protective Effects of LANTUS Treatment in Type 2 Diabetes Patients","official_title":"Beta Cell Relieving and Cardiovascular Protective Effects of LANTUS Treatment in Type 2 Diabetes Patients - Investigation on Postprandial Excursions of Proinsulin and PAI-1 Levels","primary_completion_date":"2010-07-31","study_type":"Observational","rec_status":"Completed","completion_date":"2010-07-31","last_update":"2010-09-22","description":"The purpose of this phase IV clinical trial is to investigate the effect of Insulin glargine + metformin treatment vs. sulfonylurea + metformin treatment vs. DPP-4 + metformin treatment vs. healthy volunteers on -cell function after the uptake of a standardized meal.","other_id":"SAN-FORST-001","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":40,"maximum_age":75,"population":"-  Group 1 (n=20): Healthy subjects\r\n\r\n          -  Group 2 (n=20): T2DM patients treated with continuous SU + MET therapy as individually\r\n             prescriped by the primary care physicians\r\n\r\n          -  Group 3 (n=20): T2DM patients treated with continuous LANTUS + MET therapy as\r\n             individually prescriped by the primary care physicians\r\n\r\n          -  Group 4 (n=20): T2DM patients treated with continuous DPP-4 + MET therapy as\r\n             individually prescriped by the primary care physicians","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Inclusion criteria - applicable for T2DM group only:\r\n\r\n             1.1. Type 2 diabetes mellitus 1.2. Duration of T2DM between 3 and 15 years inclusively\r\n             1.3. HbA1c up to 7.5% inclusively 1.4. Treated with LANTUS+MET (Group LANTUS+MET) or\r\n             SU+MET (Group SU+MET) or DPP-4+MET (Group DPP-4+MET) respectively during the past 6\r\n             months before entering the study 1.5. Treated on a stable antidiabetic dosage during\r\n             the past 3 months before entering the study\r\n\r\n          2. Inclusion criteria - applicable for healthy subject only:\r\n\r\n             2.1. Fasting blood glucose  100 mg/dl (5.6 mmol/l) 2.2. Oral Glucose Tolerance Test\r\n             (OGTT) revealed no IGT or DM\r\n\r\n             Inclusion criteria - applicable for all subjects:\r\n\r\n          3. Age of 40-75 years inclusively\r\n\r\n          4. BMI between 20 and 35 kg/m2 inclusively\r\n\r\n          5. Patient informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Exclusion criteria - applicable for T2DM group only:\r\n\r\n             1.1. Type 1 diabetes mellitus 1.2. Treatment with any other insulin than LANTUS during\r\n             the past 6 months in Group LANTUS+MET or with any kind of insulin during the past 3\r\n             months in Group SU+MET or Group DPP-4+MET before entering the study 1.3. Treatment\r\n             with any kind of OAD except MET during the past 6 months in Group LANTUS+MET or with\r\n             any kind of OAD except MET+SU during the past 3 months in Group SU+MET or with any\r\n             kind of OAD except DPP-4+SU during the past 3 months in Group DPP-4+MET before\r\n             entering the study 1.4. Major micro- or macro vascular complications as judged by the\r\n             investigator\r\n\r\n          2. Exclusion criteria - applicable for healthy subject only:\r\n\r\n             2.1. Type 1 or type 2 diabetes mellitus (checked by oGTT) 2.2. Impaired Glucose\r\n             Tolerance (IGT, checked by oGTT) 2.3. Impaired Fasting Glucose (IFG, checked by oGTT)\r\n\r\n             Exclusion criteria - applicable for all subjects:\r\n\r\n          3. History of drug or alcohol abuse within the last five years prior to screening\r\n\r\n          4. History of severe or multiple allergies\r\n\r\n          5. Treatment with any other investigational drug within 3 months prior to screening\r\n\r\n          6. Progressive fatal disease\r\n\r\n          7. Known psychiatric illness\r\n\r\n          8. History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT\r\n             and/or ASAT > 3 times the normal reference range), renal (creatinine > 1.1 mg/dl in\r\n             women and > 1.5 mg/dl in men), neurological, psychiatric and/or haematological disease\r\n             as judged by the investigator\r\n\r\n          9. Pregnancy or breast feeding\r\n\r\n         10. Sexually active women of childbearing potential not consistently and correctly\r\n             practicing birth control by implants, injectables, combined oral contraceptives,\r\n             hormonal intrauterine devices (IUDs), sexual abstinence or vasectomised partner\r\n\r\n         11. Lack of compliance or other similar reason, that according to investigator, precludes\r\n             satisfactory participation in the study\r\n      ","sponsor":"ikfe-CRO GmbH","sponsor_type":"Industry","conditions":"Diabetes Mellitus, Type 2","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Investigation of ß-cell function via comparison of AUC0-300 minutes of intact Proinsulin in T2DM patients treated with LANTUS + Metformin (MET) vs. T2DM patients treated with Sulfonylurea (SU) + Metformin","time_frame":"0-300 minutes after standardized meal","description":"Comparison of AUC0-300 min [intact Proinsulin] between T2DM patients treated with LANTUS + Metformin and T2DM patients treated with Sulfonylurea + MET after uptake of standardized meal"},{"outcome_type":"secondary","measure":"Investigation of insulin, intact proinsulin, glucose and PAI-1 levels over a 5 h period after uptake of a standardized meal comparing four different population groups","time_frame":"0-300 minutes after standardized meal","description":"Comparison of the AUC0-300 of intact proinsulin between each of the 4 treatment groups with the exception of T2DM patients treated with LANTUS + MET and T2DM patients treated with SU + MET after uptake of a standardized meal.\r\nComparison of the AUC0-300 for insulin, the AUC0-300 and the AUC0-180 for blood glucose, the mean maximum levels of intact proinsulin, insulin and BG, and the PAI-1 level excursion at the time points 0, 150 and 300 min between each of the 4 treatment groups.\r\nComparison of the change in the insulin/intact proinsulin ratio between each of the 4 treatment groups"}]}
{"nct_id":"NCT01262105","start_date":"2009-11-30","phase":"N/A","enrollment":23,"brief_title":"Device to Reduce Surgery Site Contamination - Spine","official_title":"Reduction of Airborne Microbes in the Surgical Field During Spine Procedures Using Directed Local Airflow","primary_completion_date":"2010-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-12-31","last_update":"2012-04-11","description":"The objective of this study is to determine whether the Air Barrier System device reduces airborne colony-forming units (e.g. bacteria) present at a surgery site during spinal procedures.","other_id":"ABS-002","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"Double","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Candidate for instrumented posterior lumbar interbody fusion\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior history of infection\r\n\r\n          -  Revision surgery\r\n\r\n          -  Screens positive for MRSA\r\n      ","sponsor":"Nimbic Systems, LLC","sponsor_type":"Industry","conditions":"Surgery","interventions":[{"intervention_type":"Device","name":"Device: Air Barrier System Device","description":"Device is deployed adjacent to the surgery site and activated so that the filtered air emits over the site."}],"outcomes":[{"outcome_type":"primary","measure":"Surgery Site CFU Density","time_frame":"Ten-minute intervals throughout procedure","description":"CFU culture counts for samples taken in surgery."}]}
{"nct_id":"NCT01052168","start_date":"2009-11-30","phase":"N/A","enrollment":42,"brief_title":"Do Motion Metrics Lead to Improved Skill Acquisition on Simulators?","official_title":"Do Motion Metrics Lead to Improved Skill Acquisition on Simulators?","primary_completion_date":"2011-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-12-31","last_update":"2013-03-25","description":"Emphasizing the growing popularity of motion metrics are the majority of available virtual reality simulators and some newer hybrid models that offer motion tracking for performance assessment. A popular hybrid model (PROMIS) allows training with regular laparoscopic instruments in a box-trainer while automatically recording task duration and movement efficiency (pathlength and smoothness) that are immediately offered as feedback to trainees. Despite the increasing availability of simulators that track motion, our knowledge of the impact those metrics have on trainee learning is severely limited. We do not know if it is more important to use speed, accuracy, motion efficiency or a combination thereof for performance assessment and how these metrics impact skill transfer to the OR. Based on sound educational principles we have developed a proficiency-based laparoscopic suturing simulator curriculum. This curriculum focuses on deliberate and distributed practice, provides trainees with augmented feedback and sets expert-derived performance goals based on time and errors. We have previously demonstrated that this curriculum leads to improved operative performance of trainees compared to controls. To measure operative performance and determine transferability, we will use a live porcine Nissen fundoplication model. Instead of placing actual patients at risk, the porcine model is preferable for this purpose as it offers objective metrics (targets are established, distances measured, knots are disrupted for slippage scoring), complete standardization, and allows multiple individuals to be tested on the same day. We hypothesize that proficiency-based simulator training in laparoscopic suturing to expert-derived levels of speed and motion will result in better operative performance compared to participants training to levels of speed or motion alone. The study is powered to detect an at least 10% performance difference between the groups. Specific Aims 1. Compare whether any performance differences between the groups persist long-term 2. Assess whether the groups demonstrate differences in safety in the operating room by comparing the inadvertent injuries in the animal OR between the groups 3. Identify the training duration required by novices to reach proficiency in laparoscopic suturing based on speed, motion efficiency, or a combination of these metrics 4. Identify any baseline participant characteristics that may predict individual metric-specific performance","other_id":"11-06-20E","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"Single","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  novices with no previous laparoscopic or simulation experience\r\n\r\n          -  voluntary participation\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  expert in or familiarity with laparoscopy or simulation\r\n\r\n          -  physical condition that prevents the performance of laparoscopic suturing\r\n      ","sponsor":"Atrium Health","sponsor_type":"Other","conditions":"Performance Assessment|Motion Metrics","interventions":[{"intervention_type":"Other","name":"Other: skills training","description":"participants will train using different performance goals (based on different metrics)"}],"outcomes":[{"outcome_type":"primary","measure":"Laparoscopic suturing performance in the animal operating room","time_frame":"end of training and retention test after 3 months"},{"outcome_type":"secondary","measure":"inadvertent injuries in the animal OR","time_frame":"end of training test and 3 month retention test"},{"outcome_type":"secondary","measure":"training duration required by novices to reach proficiency in laparoscopic suturing based on speed, motion efficiency, or a combination of these metrics","time_frame":"end of study (within one year)"}]}
{"nct_id":"NCT01028924","start_date":"2009-11-30","phase":"Phase 1","enrollment":72,"brief_title":"Effects of Teduglutide on Cardiac Repolarisation and Conduction in Healthy Male and Female Volunteers","official_title":"A Randomised, 4-period, Placebo and Active-controlled, Single-dose, Change-over Trial to Evaluate the Effects of Teduglutide on Cardiac Repolarisation and Conduction in Healthy Male and Female Volunteers","primary_completion_date":"2010-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-04-30","last_update":"2012-05-07","description":"The primary objective of this trial is to investigate if teduglutide has an effect on cardiac repolarisation (QT, QTc interval). Secondary objectives are the investigation of possible effects on heart rate and cardiac conduction (RR and PR intervals, QRS duration), pharmacokinetics and safety and tolerability in healthy subjects, and to determine the effect of the positive control, moxifloxacin, for sensitivity analysis. The trial will consist of a screening and a treatment phase of four treatment periods. There is a washout period of at least 7 days and 4 weeks at maximum between administrations. The expected total trial duration for the individual subject will be about 7 weeks (maximum 17) weeks.","other_id":"TE-1777-102-EC","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy male or female volunteers\r\n\r\n          -  Normal body weight (body mass index within 18 and 29 kg/m2 (inclusive) and a body\r\n             weight >50 kg (females) and >60 kg (males).\r\n      ","sponsor":"Nycomed","sponsor_type":"Industry","conditions":"Healthy","interventions":[{"intervention_type":"Drug","name":"Drug: Teduglutide","description":"subcutaneous (SC), single dose"}],"outcomes":[{"outcome_type":"primary","measure":"ECG measurement/assessment to determine the effect of a single dose of teduglutide on cardiac repolarisation (QT, QTc interval).","time_frame":"until 24 h post dose"},{"outcome_type":"secondary","measure":"ECG measurement/assessment to determine the effect of a single dose of a positive control, moxifloxacin, on cardiac repolarisation, heart rate, and conduction","time_frame":"until 24 h post dose"},{"outcome_type":"secondary","measure":"ECG measurement/assessment to determine the effect of a single dose of teduglutide on heart rate and cardiac conduction (RR and PR intervals, QRS duration)","time_frame":"until 24 h post dose"},{"outcome_type":"secondary","measure":"PK blood samples to investigate pharmacokinetics of teduglutide in plasma","time_frame":"until 24 h post dose"},{"outcome_type":"secondary","measure":"PK blood samples to explore the concentration effect relationship on QT/QTc intervals","time_frame":"until 24 h post dose"},{"outcome_type":"secondary","measure":"ECG measurement/assessment and PK blood samples to investigate safety and tolerability of teduglutide","time_frame":"within 14 days after trial medication administration"}]}
{"nct_id":"NCT01068470","start_date":"2009-11-30","enrollment":11,"brief_title":"Determining the Lymphokine Activated Killer (LAK) Cytotoxicity Present in Patients Undergoing Interleukin-2 Therapy","official_title":"Lymphokine Activated Killer (LAK) Cell Activity Against Cell Lines In-vitro of LAK Generated in Vivo by Pulse Interleukin-2 Therapy","primary_completion_date":"2010-12-31","study_type":"Observational","rec_status":"Terminated","completion_date":"2012-03-31","last_update":"2014-05-29","description":"Therapy with Interleukin-2 stimulates lymphocytes in humans to become Lymphokine-activated Killer cells (LAK). This study will determine if these killer cells are able to kill certain standard cell-lines in the laboratory.","other_id":"59210","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients undergoing Interleukin-2 therapy under the care of physicians at Loma Linda\r\n        University Cancer Center","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients must be undergoing Interleukin-2 therapy under the care of physicians at Loma\r\n             Linda University Cancer Center\r\n\r\n          -  Patients must sign and give written informed consent in accordance with institutional\r\n             and federal guidelines\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients not undergoing Interleukin-2 therapy under the care of physicians at Loma\r\n             Linda University Cancer Center\r\n      ","sponsor":"Loma Linda University","sponsor_type":"Other","conditions":"Melanoma|Kidney Cancer","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"LAK cytotoxicity","time_frame":"4 months"}]}
{"nct_id":"NCT01222624","start_date":"2009-11-30","phase":"Phase 1","enrollment":74,"brief_title":"PankoMab-GEX: Phase 1 Dose Escalation Study","official_title":"Phase I Dose Escalation Study Evaluating the Safety and Tolerability of PankoMab-GEX in Patients With Advanced, TA-MUC1 Positive Solid Malignancies Who Are Not Longer Eligible for Standard Therapy","primary_completion_date":"2012-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-05-31","last_update":"2021-05-20","description":"Prospective, open label, dose escalating, multicenter, phase I study measuring the safety, tolerability, and pharmacokinetics of PankoMab-GEX after intravenous administration in patients with locally advanced or metastatic solid cancers refractory to standard treatment. The effect of PankoMab-GEX on the development of antibodies and tumor response was also evaluated.","other_id":"GEXMab25101","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Male or female and age  18 yrs\r\n\r\n          2. Histologically-confirmed TA-MUC1 positive measurable or non-measurable solid tumors\r\n             according to RECIST criteria who failed standard therapy and for whom no further\r\n             standard therapy is available (TA-MUC1 positivity assessed by PankoMab-GEX staining\r\n             in immunohistology of the tumor).\r\n\r\n          3. Failure of standard therapy or non-availability of standard therapy\r\n\r\n               -  Patients must have received at least 1 standard chemotherapy during the course of\r\n                  the tumor disease\r\n\r\n               -  All therapies must be completed 6 weeks (therapeutic monoclonal antibodies) or 4\r\n                  weeks (all other anti-cancer agents) before start of study treatment and patients\r\n                  must have recovered from all prior therapy toxicities to at least CTCAE grade 1\r\n\r\n          4. Performance status: Eastern Cooperative Oncology Group (ECOG) 0-1 and estimated life\r\n             expectancy of > 3 months\r\n\r\n          5. Adequate organ function as assessed by the following laboratory parameters within 14\r\n             days prior to study drug application:\r\n\r\n               -  Bone marrow function: hemoglobin  100 g/L; white blood cell count (WBC)  3.0 x\r\n                  10^9/L; absolute neutrophil count (ANC)  1.5x 10^9/L; platelet count  100 x\r\n                  10^9/L\r\n\r\n               -  Hepatic: aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) \r\n                  2.5 times upper limit of normal (ULN) ( 5 x ULN if hepatic metastases present);\r\n                  bilirubin  1.5 x ULN; alkaline phosphatase  5.0 times upper limit of normal\r\n                  (ULN)\r\n\r\n               -  Renal: Calculated creatinine clearance > 80 ml/min using the Modification of Diet\r\n                  in Renal Disease (MDRD) formula according to Levey 2005: Glomerular filtration\r\n                  rate (GFR) (ml/min/1.73 m) = 186 x (serum creatinine /0,95)^-1.154 x\r\n                  (age)^-0.203 x (0.742 females) x (1.21 in black patients)\r\n\r\n          6. Patients of both genders with procreative potential must use effective contraception\r\n             while enrolled in the study and for at least 6 weeks after the last study drug\r\n             infusion\r\n\r\n          7. Written informed consent must be obtained prior to conducting any study-specific\r\n             procedures\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Antibody-based immunotherapy within 6 weeks and chemotherapy, radiation or other\r\n             anti-cancer therapies within 4 weeks prior to study enrolment\r\n\r\n          2. Any investigational agents at the study enrolment\r\n\r\n          3. Concurrent anti-tumor therapy or concurrent immunotherapy\r\n\r\n          4. Concurrent systemic steroids except topical (inhaled, topical, nasal), replacement\r\n             therapy for the last 28 days. Steroids at low and stable dose (up to 20 mg prednisone)\r\n             given for chronic disease are also permitted\r\n\r\n          5. History of allergic reactions to previous antibody therapy\r\n\r\n          6. Major surgery within 4 weeks prior entering the study and/or incomplete recovery from\r\n             surgery or planned major surgery\r\n\r\n          7. Documented history of active autoimmune disorders requiring systemic immunosuppressive\r\n             therapy such as sarcoidosis, lupus erythematosus, rheumatoid arthritis,\r\n             glomerulonephritis or systemic vasculitis (except autoimmune thyroiditis with only\r\n             thyroid hormone replacement and stable disease >1 year)\r\n\r\n          8. Primary or secondary immune deficiency\r\n\r\n          9. Clinically active infections > CTCAE grade 2\r\n\r\n         10. Prior allergic reaction to a monoclonal antibody (e.g. Trastuzumab, Cetuximab or\r\n             Bevacizumab).\r\n\r\n         11. Active hepatitis B or C; human immunodeficiency virus (HIV) seropositivity\r\n\r\n         12. Any concurrent malignancy other than basal cell carcinoma or carcinoma in situ of the\r\n             cervix. Patients with a previous malignancy but without evidence of disease for 3\r\n             years will be allowed to enter the study.\r\n\r\n         13. Uncontrolled medical condition considered as high risk for the treatment with an\r\n             investigational drug including unstable diabetes mellitus, vena-cava-syndrome, chronic\r\n             symptomatic respiratory disease.\r\n\r\n         14. Brain metastasis or leptomeningeal involvement\r\n\r\n         15. Symptomatic congestive heart failure (New York Heart Association [NYHA] 3 or 4);\r\n             unstable angina pectoris within 6 months prior to enrollment; significant cardiac\r\n             arrhythmia, history of stroke or transient ischemic attack within 1 year or left\r\n             ventricular ejection fraction (LVEF) below the institutional range of normal on a\r\n             baseline multiple gated acquisition (MUGA) scan or echocardiogram (ECHO)\r\n\r\n         16. History of seizures, encephalitis or multiple sclerosis\r\n\r\n         17. History of deep vein thrombosis and/or thromboembolic events within the past 6 months\r\n             before entering the study and/or requiring anticoagulation therapy\r\n\r\n         18. Evidence or history of bleeding diathesis or coagulopathy\r\n\r\n         19. Active drug abuse or chronic alcoholism\r\n\r\n         20. Pregnancy or breastfeeding\r\n      ","sponsor":"Glycotope GmbH","sponsor_type":"Industry","conditions":"Solid Tumors","interventions":[{"intervention_type":"Drug","name":"Drug: PankoMab-GEX"}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of Treatment-Emergent Adverse Events assessed with the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE], Version 3.0","time_frame":"Until 28±2 days following the last infusion","description":"Adverse events coded using Medical Dictionary for Regulatory Activities (MedDRA) version 13.1"},{"outcome_type":"primary","measure":"Incidence of Treatment-Emergent abnormal clinical laboratory parameters assessed with the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE], Version 3.0","time_frame":"Until 28±2 days following the last infusion","description":"Analyzed in local clinical laboratories"},{"outcome_type":"primary","measure":"Changes in corrected QT interval (QTc) duration","time_frame":"Until 28±2 days following the last infusion","description":"based on Electrocardiograms (ECG)"},{"outcome_type":"primary","measure":"Changes of left ventricular ejection fraction (LVEF)","time_frame":"Until 28±2 days following the last infusion","description":"based on Multiple Gated Acquisition (MUGA) scan or Echocardiogram (ECHO)"},{"outcome_type":"primary","measure":"Eastern Cooperative Oncology Group (ECOG) Performance Status","time_frame":"Until 28±2 days following the last infusion","description":"The ECOG Scale of Performance Status describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). The scale comprises six grades:\r\n0 Fully active, able to carry on all pre-disease performance without restriction\r\nRestricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work\r\nAmbulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours\r\nCapable of only limited selfcare; confined to bed or chair more than 50% of waking hours\r\nCompletely disabled; cannot carry on any selfcare; totally confined to bed or chair\r\nDead"},{"outcome_type":"secondary","measure":"Pharmacokinetics (PK): Peak Plasma Concentration (Cmax)","time_frame":"Assessment prior to and 2 min before the end of first infusion, 1 hr and 3 hrs after end of first infusion and 24 hrs after start of first infusion, on Day 2, Day 4, Day 7, Day 14, and then prior to and after end of each infusion up to 15 weeks","description":"PK of PankoMab-GEX™ in patients after single and multiple dose applications"},{"outcome_type":"secondary","measure":"Pharmacokinetics (PK): Minimum Drug Concentration (Cmin)","time_frame":"Assessment prior to and 2 min before the end of first infusion, 1 hr and 3 hrs after end of first infusion and 24 hrs after start of first infusion, on Day 2, Day 4, Day 7, Day 14, and then prior to and after end of each infusion up to 15 weeks","description":"PK of PankoMab-GEX™ in patients after single and multiple dose applications"},{"outcome_type":"secondary","measure":"Pharmacokinetics (PK):Time to reach Cmax (tmax)","time_frame":"Assessment prior to and 2 min before the end of first infusion, 1 hr and 3 hrs after end of first infusion and 24 hrs after start of first infusion, on Day 2, Day 4, Day 7, Day 14, and then prior to and after end of each infusion up to 15 weeks","description":"PK of PankoMab-GEX™ in patients after single and multiple dose applications"},{"outcome_type":"secondary","measure":"Pharmacokinetics (PK): Area under the curve (AUC)","time_frame":"Assessment prior to and 2 min before the end of first infusion, 1 hr and 3 hrs after end of first infusion and 24 hrs after start of first infusion, on Day 2, Day 4, Day 7, Day 14, and then prior to and after end of each infusion up to 15 weeks","description":"PK of PankoMab-GEX™ in patients after single and multiple dose applications"},{"outcome_type":"secondary","measure":"Pharmacokinetics (PK): Apparent terminal serum half-life (t1/2)","time_frame":"Assessment prior to and 2 min before the end of first infusion, 1 hr and 3 hrs after end of first infusion and 24 hrs after start of first infusion, on Day 2, Day 4, Day 7, Day 14, and then prior to and after end of each infusion up to 15 weeks","description":"PK of PankoMab-GEX™ in patients after single and multiple dose applications"},{"outcome_type":"secondary","measure":"To evaluate any immunogenicity","time_frame":"Anti-drug antibodies (ADAs) were to be measured before the first infusion of study medication, prior to the second infusion, 4 weeks and 8 weeks after the last study medication administration.","description":"Anti-drug antibodies (ADAs)"},{"outcome_type":"secondary","measure":"Tumor response: Best observed response","time_frame":"From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months","description":"Tumors were measured by computed tomography (CT)-scan or magnetic resonance imaging (MRI) and evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1"},{"outcome_type":"secondary","measure":"Tumor response: Objective response rate (ORR)","time_frame":"From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months","description":"Tumors were measured by computed tomography (CT)-scan or magnetic resonance imaging (MRI) and evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1"},{"outcome_type":"secondary","measure":"Tumor response: Clinical benefit rate (CBR)","time_frame":"From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months","description":"Tumors were measured by computed tomography (CT)-scan or magnetic resonance imaging (MRI) and evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1"},{"outcome_type":"secondary","measure":"Tumor response: Duration of response","time_frame":"From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months","description":"Tumors were measured by computed tomography (CT)-scan or magnetic resonance imaging (MRI) and evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1"},{"outcome_type":"secondary","measure":"Tumor response: Duration of stable disease","time_frame":"From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months","description":"Tumors were measured by computed tomography (CT)-scan or magnetic resonance imaging (MRI) and evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1"}]}
{"nct_id":"NCT01086904","start_date":"2009-11-30","phase":"Phase 2","enrollment":120,"brief_title":"Safety and Efficacy of an Inactivated and Non Adjuvanted Vaccine Against Influenza A in Renal Transplant Recipients","official_title":"Etude de Phase II valuant l'immunognicit et la tolrance d'un Vaccin inactiv Non adjuvant Contre la Grippe A (H1N1) aprs Transplantation rnale","primary_completion_date":"2010-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-05-31","last_update":"2012-01-02","description":"The study is aimed at assessing the safety and efficacy of an inactivated and non adjuvanted Influenza A (H1N1) vaccine in renal transplant recipients.","other_id":"C09-32","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion criteria:\r\n\r\n          -  Age > 18 and < 60 years old\r\n\r\n          -  Signed information consent\r\n\r\n          -  Social security coverage\r\n\r\n          -  Renal transplantation > 6 months with a creatinine clearance > 20 ml/mn\r\n\r\n          -  Stable renal function defined as serum creatinine variation < 20 % for the last three\r\n             months\r\n\r\n          -  Receiving a triple immunosuppression regimen including steroids, Calcineurine\r\n             inhibitors (cyclosporine or Tacrolimus), and IMPDH inhibitors (Mycophenolate Mofetil\r\n             or mycophenolic acid)\r\n\r\n          -  Regular follow-up\r\n\r\n        For child bearing aged female:\r\n\r\n          -  Negative urinary HCG\r\n\r\n          -  Contraception during the first three months of the study\r\n\r\n        Exclusion criteria:\r\n\r\n          -  Poor renal function defined as creatinine clairance < 20 ml/mn\r\n\r\n          -  Unstable renal function defined as serum creatinine variations > 20 % during the last\r\n             3 months\r\n\r\n          -  Cellular or humoral acute rejection episode during the last 3 months before inclusion\r\n\r\n          -  Known HIV, HBV or HCV infection\r\n\r\n          -  Other vaccine administered during the last 3 weeks before inclusion or scheduled in\r\n             the month after the second vaccine injection\r\n\r\n          -  Known allergy to egg proteins or to one the vaccine compounds\r\n\r\n          -  Severe adverse events after prior administration of any influenza vaccine\r\n\r\n          -  Multiple sclerosis\r\n\r\n          -  Past history of Guillain Barre syndrome\r\n\r\n          -  Fever at inclusion\r\n\r\n          -  H1N1 influenza episode with positive virological tests during the last 6 months\r\n\r\n          -  Contact with people infected with H1N1 influenza during the week prior to inclusion\r\n\r\n          -  Cancer requiring radiotherapy or chemotherapy during the last 6 months\r\n\r\n          -  Blood transfusion during the last 3 months\r\n\r\n          -  Pregnancy during the last 3 months\r\n\r\n          -  No follow-up\r\n      ","sponsor":"Institut National de la Sant Et de la Recherche Mdicale, France","sponsor_type":"Other","conditions":"Renal Transplant Recipients|Immunosuppression","interventions":[{"intervention_type":"Biological","name":"Biological: inactivated non adjuvanted pandemic H1N1 vaccine","description":"two administrations at D and D21 (15 g HA)"}],"outcomes":[{"outcome_type":"primary","measure":"Specific humoral response 21 days after each administration Seroprotection and seroconversion rates","time_frame":"after each vaccination and at 6 months"},{"outcome_type":"secondary","measure":"Seroprotection and seroconversion rates at day 182;Percentage of patients with anti-H1N1v Antibodies >1/40e at day 182; Number of undesired events and of Influenza A cases; Assessment of cellular immune response against Influenza A H1N1; Effect of vacc","time_frame":"6 months"}]}
{"nct_id":"NCT00979355","start_date":"2009-11-30","phase":"N/A","enrollment":0,"brief_title":"Study to Compare a Fast Gama Camera for Nuclear Imaging to Conventional Camera","official_title":"Evaluation of Multi Purpose D-spect Camera for General Nuclear Scans","primary_completion_date":"2010-12-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2010-12-31","last_update":"2019-06-14","description":"A feasibility trial to evaluate the usefulness of a high efficiency camera (D-SPECT) as an imaging modality for general nuclear medicine applications such as oncology.","other_id":"GP- DSpect_001","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patient is referred to nuclear medicine department for a SPECT scan.\r\n\r\n          2. Written informed consent is obtained by a study investigator.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patient pregnancy (known or suspected).\r\n\r\n          2. Lack of written informed consent\r\n\r\n          3. Prisoner status\r\n\r\n          4. Patient under age 18 or over 80 years old.\r\n      ","sponsor":"Spectrum Dynamics","sponsor_type":"Industry","conditions":"Detect Pathalogical Lesions","interventions":[{"intervention_type":"Device","name":"Device: GP-D-SPECT","description":"The D-SPECT system uses a solid-state detector, made of an alloy of Cadmium, Zinc, and Telluride, eliminating the need for thick crystals and large PMTs. As a result, the system is significantly miniaturized, and ergonomically optimized to both user and patient."}],"outcomes":[{"outcome_type":"primary","measure":"A comparison of high efficiency camera images (D-SPECT) to a conventional camera (A-SPECT) with respect to the ability to detect pathological lesions.","time_frame":"12 month"},{"outcome_type":"secondary","measure":"A comparison of high efficiency camera images (D-SPECT) to a conventional camera (A-SPECT) with respect to image quality/resolution","time_frame":"12 month"}]}
{"nct_id":"NCT01046266","start_date":"2009-11-30","phase":"Phase 1","enrollment":62,"brief_title":"A Study of Pharmacodynamics of RO5083945 in Patients With Head and Neck Squamous Cell Carcinoma","official_title":"An Exploratory, Open Label Multicenter Study to Investigate Pharmacodynamic of RO5083945, a Human Monoclonal Antibody Antagonist of Epidermal Growth Factor Receptor (EGFR), Compared to Cetuximab in Patients With Operable Head and Neck Squamous Cell Carcinoma","primary_completion_date":"2012-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-06-30","last_update":"2016-09-14","description":"This open-label study will assess the pharmacodynamics, safety and efficacy of RO5083945 as compared to cetuximab in patients with head and neck squamous cell carcinoma. Patients will receive at least 2 infusions of either RO5083945 or cetuximab. Anticipated time on study treatment is up to 3 months, and target sample size is <50.","other_id":"BP22350","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  adult patients, >/=18 years of age\r\n\r\n          -  squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  carcinoma of nasal cavity, paranasal sinus and nasopharynx\r\n\r\n          -  recurrent squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or\r\n             larynx\r\n\r\n          -  known positivity for HIV, hepatitis B and/or hepatitis C infection\r\n      ","sponsor":"Hoffmann-La Roche","sponsor_type":"Industry","conditions":"Head and Neck Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: RO5083945","description":"700mg iv weekly"},{"intervention_type":"Drug","name":"Drug: cetuximab","description":"400mg/m2 iv 1st dose, 250mg/m2 iv subsequent weekly doses"}],"outcomes":[{"outcome_type":"primary","measure":"immune cell infiltration head and neck squamous cell cancer (HNSCC)","time_frame":"through study completion or early study discontinuation"},{"outcome_type":"secondary","measure":"pharmacodynamics: T lymphocytes, B lymphocytes, NK cells, plasma cytokine levels","time_frame":"through study completion or early study discontinuation"},{"outcome_type":"secondary","measure":"safety and efficacy: AEs, laboratory parameters, tumour assessments","time_frame":"through study completion or early study discontinuation"}]}
{"nct_id":"NCT01082796","start_date":"2009-11-30","phase":"N/A","enrollment":14,"brief_title":"Cytochrome P450 2C19 Variant is Related to Pharmacokinetics of Glipizide Extended Release Tablet in Chinese Subjects","official_title":"Investigate the Relationship Between CYP2C19 Genetic Polymorphisms and Pharmacokinetics of Glipizide in Healthy Chinese Subjects","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-01-31","last_update":"2010-03-09","description":"Diabetes mellitus is a growing global disease now and future, and in China, 1.2 million peoples per year have been diagnosed as diabetes mellitus. 90% diabetes mellitus patient is Type 2 diabetes mellitus. Glipizide is a potent drug to service patients who suffer from Type 2 disease. Little information has been presented for the relationship between CYP2C19 genetic polymorphism and glipizide, since recently the investigators reported that there existed a tendency. In this study the investigators found that CYP2C19 polymorphism significantly influenced the pharmacokinetics of glipizide.","other_id":"SIMM-DMPK-090903","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"Single","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  male\r\n\r\n          -  healthy\r\n\r\n          -  nonsmokers\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  BMI > 24 or BMI < 19\r\n\r\n          -  had any family history of diabetes mellitus\r\n      ","sponsor":"Chinese Academy of Sciences","sponsor_type":"Other","conditions":"Genotype|Pharmacokinetic","interventions":[{"intervention_type":"Drug","name":"Drug: Glipizide","description":"Each subject received 5 mg glipizide extended release tablet once daily for 7 days."}],"outcomes":{}}
{"nct_id":"NCT02220673","start_date":"2009-11-30","phase":"Phase 1","enrollment":61,"brief_title":"Serial Lung Function Measurements in Healthy and Mild Asthmatic Adults After Oral Inhalation of Ethanolic Solutions Containing Two Concentrations of the Excipient Butylated Hydroxytoluene (BHT) Administered With the Respimat B (RMT-B)","official_title":"Serial Lung Function Measurements in 12 Healthy and 48 Mild Asthmatic Adults After Oral Inhalation of Ethanolic Solutions Containing Two Concentrations of the Excipient Butylated Hydroxytoluene (BHT, 0.1% and 0.5%) Administered With the Respimat B (RMT-B) vs. Corresponding RMT-B and HFA MDI Without BHT; Repeated Increasing Doses With 2, 4, and 6 Actuations of Low Concentration Prior to High Concentration on Separate Days, Double Blind for RMT-B Use, Randomised 4-way Cross-over Design","primary_completion_date":"2010-05-31","study_type":"Interventional","rec_status":"Completed","last_update":"2014-08-20","description":"Primary objective: To investigate the safety and local tolerability of increasing cumulative doses (2, 4, 6 actuations) of a low (0.1%) and a high (0.5%) concentration of BHT administered via oral inhalation with the Respimat inhaler B (RMT-B) vs. 2 inhalation solutions without BHT (placebo to BHT given by RMT B and placebo given by hydroxylfluoralkane metered dose inhaler (HFA MDI)). In a first step, the trial was performed in healthy subjects and - if no safety concerns arose - in a second step in patients with mild asthma who were sensitive to metacholine in a respective challenge test. Secondary objective: To explore the pharmacokinetics (PK) of BHT.","other_id":"1256.13","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Healthy subjects\r\n\r\n          -  Male or female adult subjects\r\n\r\n          -  Age  18 and  65 years\r\n\r\n          -  Body mass index (BMI)  18.5 and  32.0 kg/m2\r\n\r\n          -  Non-smokers (within the last 5 years)\r\n\r\n          -  Signed and dated written informed consent prior to admission to the trial in\r\n             accordance with Good Clinical Practice (GCP) and the local legislation\r\n\r\n          -  Proper use of RMT and MDI\r\n\r\n          -  Able to perform technically satisfactory pulmonary function test\r\n\r\n        Patients with mild asthma\r\n\r\n          -  Male or female adult subjects with intermittent and mild persistent asthma\r\n\r\n          -  Age  18 and  65 years\r\n\r\n          -  Body mass index (BMI)  18.5 and  32.0 kg/m2\r\n\r\n          -  FEV1  70% predicted and stable for at least 7 days prior to randomization\r\n\r\n          -  Short acting beta agonist (SABA) response documented in the last 6 months\r\n\r\n          -  A history of wheeze, cough, dyspnoea or chest tightness following exposure to at least\r\n             one of the following: cold, exercise, dry air, smoke, dust, allergens\r\n\r\n          -  Positive methacholine challenge test reflecting mild to moderate bronchial\r\n             hyperreactivity (PC20: 0.25-4.0 mg/mL) performed within two weeks prior randomization\r\n             (at visit 1 or between visit 1 and 2)\r\n\r\n          -  None or stable dosages of pulmonary medications (SABA only) in the past 6 weeks\r\n\r\n          -  Non smokers or ex-smokers for the last 5 years\r\n\r\n          -  Signed and dated written informed consent prior to admission to the trial in\r\n             accordance with GCP and the local legislation\r\n\r\n          -  Proper use of RMT and MDI\r\n\r\n          -  Able to perform technically satisfactory pulmonary function test\r\n\r\n        Exclusion Criteria:\r\n\r\n        Healthy subjects\r\n\r\n          -  Any finding in the medical examination (including blood pressure (BP), pulse rate\r\n             (PR)) deviating from normal and of clinical relevance\r\n\r\n          -  Any laboratory value outside the reference range deemed of clinical relevance\r\n\r\n          -  Pregnant or breast feeding women or women of childbearing potential without having a\r\n             negative Human choriongonadotropin, -subunit (-HCG) pregnancy test and without using\r\n             a medically approved highly effective method of contraception for the previous 3\r\n             months\r\n\r\n          -  Abnormal spirometry i.e., FEV1 <80% predicted and/or methacholine challenge at\r\n             screening Visit 1 (or between Visits 1 and 2)\r\n\r\n          -  Acute or chronic bacterial and viral infections of the lung\r\n\r\n          -  History of relevant allergy/hypersensitivity (including allergy to drug or its\r\n             excipients)\r\n\r\n          -  Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular,\r\n             metabolic, immunological or hormonal disorders\r\n\r\n          -  Clinically relevant diseases of the central nervous system (such as epilepsy) or\r\n             psychiatric disorders or neurological disorders\r\n\r\n          -  Use of drugs which might reasonably influence the results of the trial within 10 days\r\n             prior to first administration or during the trial (assessed and judged by the\r\n             investigator)\r\n\r\n          -  Participation in another trial with an investigational drug within 1 month prior to\r\n             administration or during the trial\r\n\r\n          -  Alcohol abuse (more than 60 g/day)\r\n\r\n          -  Drug abuse\r\n\r\n          -  Blood donation (>120 mL within 4 weeks prior to administration or during the trial)\r\n\r\n          -  Excessive physical activities (within 1 week prior to administration or during the\r\n             trial)\r\n\r\n          -  Any vulnerable subjects\r\n\r\n          -  Inability to comply with protocol requirements, instructions and study related\r\n             restrictions, dietary regimen of trial site, and improbability of completing the study\r\n\r\n        Patients with mild asthma\r\n\r\n          -  Any finding of the medical examination (including BP, PR) deviating from normal and of\r\n             clinical relevance\r\n\r\n          -  Any laboratory value that was of clinical relevance\r\n\r\n          -  Moderate or severe persistent asthma\r\n\r\n          -  Pregnant or breast feeding women or women of childbearing potential without a negative\r\n             -HCG pregnancy test and without using a medically approved highly effective method of\r\n             contraception for the previous 3 months\r\n\r\n          -  Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular,\r\n             metabolic, immunological or hormonal disorders\r\n\r\n          -  Clinically relevant diseases of the central nervous system (such as epilepsy) or\r\n             psychiatric disorders or neurological disorders\r\n\r\n          -  Chronic or relevant acute infections\r\n\r\n          -  Treated or non-treated bacterial and viral infections of the lung, including active or\r\n             latent tuberculosis\r\n\r\n          -  Use of any corticosteroids, long acting muscarinic antagonist (LAMA) or long acting\r\n             beta agonists (LABA), all within 1 month prior to screening Visit 1 and prior to\r\n             administration of investigational product (i.e., allergic patients could only\r\n             participate outside their season)\r\n\r\n          -  Clinically relevant perennial allergies (i.e., which need actual treatment)\r\n\r\n          -  Methylxanthines, antihistamines, antileukotrienes, cromolyn/nedocromil sodium all\r\n             within 1 month prior to screening Visit 1 and prior to administration of\r\n             investigational product\r\n\r\n          -  SABAs 12 h prior to each visit day\r\n\r\n          -  Use of other drugs which reasonably influence the results of the trial within 10 days\r\n             prior to first administration or during the trial (e.g., beta blockers, all\r\n             antimuscarinic agents like phenothiazines and some antidepressants)\r\n\r\n          -  Participation in another trial with an investigational product within 1 month prior to\r\n             administration or during the trial\r\n\r\n          -  Alcohol abuse (more than 60 g/day)\r\n\r\n          -  Drug abuse\r\n\r\n          -  Blood donation (>120 mL within 4 weeks prior to administration or during the trial)\r\n\r\n          -  Excessive physical activities (within 3 days prior to administration or during the\r\n             trial)\r\n\r\n          -  Inability to comply with protocol requirements, instructions and trial related\r\n             restrictions, dietary regimen of trial site, and improbability of completing the trial\r\n\r\n          -  Any vulnerable patients\r\n      ","sponsor":"Boehringer Ingelheim","sponsor_type":"Industry","conditions":"Asthma","interventions":[{"intervention_type":"Drug","name":"Drug: BHT 0.5%"},{"intervention_type":"Drug","name":"Drug: Placebo for RMT-B"},{"intervention_type":"Drug","name":"Drug: BHT 0.1%"},{"intervention_type":"Drug","name":"Drug: Placebo for HFA-MDI"}],"outcomes":[{"outcome_type":"secondary","measure":"Area under the curve (AUC) of FEV1","time_frame":"over 3 hours after first dosing"},{"outcome_type":"secondary","measure":"AUC of FEV1","time_frame":"over 1 hours after each dosing"},{"outcome_type":"primary","measure":"Maximum decrease of forced expiratory volume in one second (FEV1)","time_frame":"baseline, 3 h after administration","description":"(Minimum FEV1 value over the interval 5 min to 2 h 50 min) minus (baseline value)"},{"outcome_type":"secondary","measure":"Maximum decrease in FEV1 after 2 actuations","time_frame":"baseline, up to 50 minutes after drug administration","description":"(minimum FEV1 value over the interval 5 min to 50 min) - (baseline value)"},{"outcome_type":"secondary","measure":"Maximum decrease in FEV1 after 4 actuations","time_frame":"baseline, up to 1:50 hours after drug administration","description":"(minimum FEV1 value over the interval 1 h 5 min to 1 h 50 min) - (baseline value)"},{"outcome_type":"secondary","measure":"Maximum decrease in FEV1 after 6 actuations","time_frame":"baseline, up to 2:50 hours after drug administration","description":"(minimum FEV1 value over the interval 2 h 5 min to 2 h 50 min) - (baseline value)"},{"outcome_type":"secondary","measure":"Number of subjects with a decrease in FEV1","time_frame":"baseline, up to 2:50 hours after drug administration","description":"stratified into classes of 0-20%, >20-40%, and >40%"},{"outcome_type":"secondary","measure":"Number of patients with cough episodes","time_frame":"up to 9 days","description":"within 5 min prior to the 1st inhalation and within 5 min after each of the 3 inhalations on each treatment day"},{"outcome_type":"secondary","measure":"Number of patients requiring rescue medication","time_frame":"up to 60 min after each dosing"},{"outcome_type":"secondary","measure":"Number of patients with adverse events","time_frame":"up to 10 days after the last treatment day"},{"outcome_type":"secondary","measure":"Cmax (maximum measured concentration of the analyte in plasma)","time_frame":"pre-dose, 2, 10, 25 and 55 min after each dosing"},{"outcome_type":"secondary","measure":"tmax (time from dosing to maximum measured concentration of the analyte in plasma)","time_frame":"pre-dose, 2, 10, 25 and 55 min after each dosing"},{"outcome_type":"secondary","measure":"AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable concentration at tz)","time_frame":"pre-dose, 2, 10, 25 and 55 min after each dosing"}]}
{"nct_id":"NCT00855699","start_date":"2009-11-30","phase":"Phase 4","enrollment":36,"brief_title":"Alcohol Detoxification in Primary Care Treatment (ADEPT)","official_title":"Alcohol Detoxification in Primary Care Treatment (ADEPT) - a Feasibility Study of Conducting a Randomised Trial in Primary Care Comparing Two Pharmacological Regimens.","primary_completion_date":"2010-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-11-30","last_update":"2011-01-19","description":"Once someone becomes dependent on alcohol (alcoholic), the risks of complications from alcohol withdrawal when they stop drinking grow. These can include a life-threatening fit or delirium tremens (see things, become frightened). To prevent such complications, people take medication such as benzodiazepines (e.g., valium or librium) in reducing doses for about a week; this is called detoxification or 'detox.' In the UK effective alcohol treatment exists but little is known about what is the best detox medication. Alternative drugs to benzodiazepines appear to protect the brain from the toxicity of alcohol withdrawal and to reduce the likelihood of drinking again. This study will examine the feasibility of comparing medication regimens for alcohol detox for the first time in primary care. It will include a standard detox regimen (librium over 8 days) alone and together with a drug, acamprosate, that has been shown to reduce toxicity of alcohol withdrawal in preclinical models and is used after detox to help people remain sober. It will focus on the practicalities of doing such a study as well as assessing how people feel (withdrawal symptoms) and do (drinking during first month).","other_id":"RED 740","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Anyone (18-65 years old) consulting their GP for whom a community based alcohol detox\r\n             requiring medication is appropriate.\r\n\r\n          -  Due to acamprosate's license for maintaining abstinence, nobody under the age of 18\r\n             and over 65 will be recruited.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Unsuitable for home/community detox, e.g., with current or significant history of:\r\n\r\n               -  delirium tremens or seizures\r\n\r\n               -  current or history of high dose polydrug use\r\n\r\n               -  significant medical or psychiatric ill health\r\n\r\n               -  pregnant or breast feeding\r\n\r\n               -  Wernicke's encephalopathy\r\n      ","sponsor":"University of Bristol","sponsor_type":"Other","conditions":"Alcoholism","interventions":[{"intervention_type":"Drug","name":"Drug: Acamprosate","description":"Acamprosate 333mg tablets, two tablets three times a day for duration of alcohol detox."}],"outcomes":[{"outcome_type":"primary","measure":"Reduction in alcohol withdrawal symptoms","time_frame":"up to 10 days"},{"outcome_type":"secondary","measure":"alcohol drinking","time_frame":"within 4 weeks of end of detox"}]}
{"nct_id":"NCT01001338","start_date":"2009-10-31","phase":"Phase 2","enrollment":227,"brief_title":"Allopurinol Combination Study","official_title":"Randomized, Double-Blind, Multicenter, Placebo-Controlled, Combination Study to Evaluate the Safety, Efficacy and Potential Pharmacokinetic Interaction of RDEA594 and Allopurinol in Gout Patients With an Inadequate Hypouricemic Response With Standard Doses of Allopurinol","primary_completion_date":"2011-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-08-31","last_update":"2017-01-24","description":"To compare the proportion of subjects whose serum urate (sUA) levels are < 6.0 mg/dL following 4 weeks of continuous treatment of RDEA594 in combination with allopurinol to allopurinol alone in subjects with documented inadequate hypouricemic response with standard doses of allopurinol.","other_id":"RDEA594-203","allocation":"Randomized","intervention_model":"Factorial Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Male or a post-menopausal or surgically sterile female.\r\n\r\n          2. 18 - 80 years of age.\r\n\r\n          3. Has been taking allopurinol as the sole urate lowering therapy for hyperuricemia for\r\n             at least 6 weeks at a dose between 200 mg and 600 mg per day without an adequate\r\n             response.\r\n\r\n          4. Has a sUA level  6 mg/dL at screening.\r\n\r\n          5. Meets criteria for the diagnosis of gout as per the American Rheumatism Association\r\n             (ARA) Criteria for the Classification of Acute Arthritis of Primary Gout.\r\n\r\n          6. Willing and able to give informed consent and adhere to visit/protocol schedules\r\n             (informed consent must be given before the first study procedure is performed).\r\n\r\n          7. Subjects entering the optional Extension Period must have completed 28 days of dosing\r\n             in the Double-Blind Treatment Period and the Day 42 Visit in the Follow-up Period\r\n             within 4 months and must not have experienced any serious adverse events considered\r\n             possibly related to study drug.\r\n\r\n          8. Subjects entering the optional Open-Label Extension Period must continue to be\r\n             compliant with the protocol through Week 44 of the Double-Blind Extension Period and\r\n             must not have experienced any serious adverse events considered possibly related to\r\n             study drug.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Consumes more than 14 drinks of alcohol per week (e.g., 1 drink = 5 oz [150 ml] of\r\n             wine, 12 oz [360 ml] of beer, or 1.5 oz [45 ml] of hard liquor).\r\n\r\n          2. History or suspicion of drug abuse.\r\n\r\n          3. History of documented or suspected kidney stones.\r\n\r\n          4. Has rheumatoid arthritis or other autoimmune disease requiring treatment.\r\n\r\n          5. Documented or suspicion of HIV infection.\r\n\r\n          6. Positive serology to HCV antibodies (Abs), and/or hepatitis B surface antigen (HBsAg).\r\n\r\n          7. History of malignancy within 5 years prior to the first dose of study medication,\r\n             other than non-melanomatous skin cancer or cervical dysplasia.\r\n\r\n          8. History of cardiac abnormalities, including abnormal and clinically relevant ECG\r\n             changes\r\n\r\n          9. Any condition predisposing to QT prolongation including pathological Q-wave (defined\r\n             as Q-wave >40 msec or depth > 0.4-0.5 mV).\r\n\r\n         10. Any use of concomitant medications that prolong the QT/QTc interval within the 14 days\r\n             prior to Baseline (Day 1).\r\n\r\n         11. QT interval corrected for heart rate according to Fridericia (QTcF) > 450 msec at\r\n             Screening or pre-dose at Baseline (Day 1).\r\n\r\n         12. Uncontrolled hypertension (above 150/95).\r\n\r\n         13. Inadequate renal function [serum creatinine >1.5 mg/dL or creatinine clearance < 60\r\n             mL/min (by Cockroft-Gault formula)].\r\n\r\n         14. Hemoglobin < 10 g/dL (males) or < 9 g/dL (females).\r\n\r\n         15. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 x upper limit\r\n             of normal (ULN).\r\n\r\n         16. Gamma glutamyl transferase (GGT) > 3 x ULN.\r\n\r\n         17. Active peptic ulcer disease requiring treatment.\r\n\r\n         18. History of xanthinuria, active liver disease, or hepatic dysfunction.\r\n\r\n         19. Requires therapy with any other urate-lowering medication, other than the study\r\n             medications.\r\n\r\n         20. Requires long-term use of salicylates; diuretics; losartan; azathioprine;\r\n             mercaptopurine; theophylline; intravenous colchicine; cyclosporine; cyclophosphamide;\r\n             pyrazinamide; sulfamethoxazole; or trimethoprim.\r\n\r\n         21. Taking medications known as enzyme inducers (see section 3.7 for listing).\r\n\r\n         22. Reports receiving a strong or moderate inhibitor of CYP3A4 or a P-gp inhibitor within\r\n             1 month prior to study drug dosing, due to potential interactions with colchicine.\r\n\r\n         23. Acute gout flare (exclusive of chronic synovitis/ arthritis) during the\r\n             Screening-Period that has not resolved one week prior to the Baseline Visit (Day 0).\r\n\r\n         24. Pregnant or breast feeding.\r\n\r\n         25. Has received an investigational medication within 4 weeks prior to the screening visit\r\n             for this study.\r\n\r\n         26. Previously participated in a clinical study involving RDEA806 or RDEA594.\r\n\r\n         27. Known hypersensitivity or allergy to RDEA594, allopurinol or colchicine or any\r\n             components in their formulations.\r\n\r\n         28. Body mass index (BMI) >48 kg/m2.\r\n\r\n         29. Taking greater than 1000 mg/day of Vitamin C.\r\n\r\n         30. Any other medical or psychological condition, which in the opinion of the Investigator\r\n             and/or Medical Monitor, might create undue risk to the subject or interfere with the\r\n             subject's ability to comply with the protocol requirements, or to complete the study.\r\n\r\n         31. Inadequate renal function after completing the Double-Blind Treatment period prior to\r\n             entering Double-Blind Extension Period.\r\n\r\n         32. Requiring treatment with prohibited medications noted in exclusion criteria numbers\r\n             20-23 after completing the Double-Blind Treatment Period prior to entering the\r\n             Extension Period.\r\n\r\n         33. Clinically relevant medical event as determined by the investigator in consultation\r\n             with medical monitor prior to entering the Extension Period.\r\n      ","sponsor":"Ardea Biosciences, Inc.","sponsor_type":"Industry","conditions":"Gout","interventions":[{"intervention_type":"Drug","name":"Drug: RDEA594","description":"Uricosuric agent for the treatment of gout."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Matching Placebo"},{"intervention_type":"Drug","name":"Drug: Allopurinol","description":"Allopurinol"}],"outcomes":[{"outcome_type":"primary","measure":"To compare the percent reduction from baseline in serum urate levels following 4 wks of continuous treatment of RDEA594 in combination with allopurinol to allopurinol alone in subjects with documented inadequate hypouricemic response.","time_frame":"28 days"},{"outcome_type":"secondary","measure":"To evaluate the proportion of subjects whose sUA levels are < 6.0 mg/dL, < 5.0 mg/dL and < 4.0 mg/dL at each study visit by treatment group in all subjects and in subjects who have an sUA ≥6 mg/dL at the baseline visit.","time_frame":"28 days and through extension"},{"outcome_type":"secondary","measure":"To evaluate the absolute and percent reduction from baseline in sUA levels at each visit.","time_frame":"28 days and through extension"},{"outcome_type":"secondary","measure":"To evaluate the percentage change in 24-hour urine urate level (excretion) from baseline to Day 28.","time_frame":"28 days and through extension"},{"outcome_type":"secondary","measure":"To evaluate the incidence of gout flares.","time_frame":"28 days and through extension"},{"outcome_type":"secondary","measure":"To evaluate the safety and tolerability of RDEA594 in combination with allopurinol in subjects with gout.","time_frame":"28 days and through extension"},{"outcome_type":"secondary","measure":"To compare the multiple-dose pharmacokinetics (PK) of allopurinol and oxypurinol in the absence versus presence of RDEA594 co-administration.","time_frame":"28 days"},{"outcome_type":"secondary","measure":"To evaluate the proportion of subjects whose sUA level decreases to or is maintained at <6.0 mg/dL and <5.0 mg/dL in the Double-Blind and Open-Label Extension Period.","time_frame":"3 years"}]}
{"nct_id":"NCT01254955","start_date":"2009-10-31","brief_title":"Antibody Production Following H1N1 Influenza Vaccination in Organ Transplant Patients","official_title":"Antibody Production Following H1N1 Influenza Vaccination in Organ Transplant Patients","primary_completion_date":"2011-01-31","study_type":"Observational","rec_status":"Completed","completion_date":"2011-08-31","last_update":"2012-01-16","description":"Organ transplant patients and staff members at the Transplant Institute have received pandemic H1N1 influenza vaccine (Pandemrix) and specific antibody production was measured by haemagglutination inhibition according to the clinical guidelines and policy, respectively. This study retrospectively assessed the immune response after vaccination.","other_id":"ALFGBG-141031","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"Tranplant patients at the out-patient clinical ward and staff members at the Transplant\r\n        Institute, Sahlgrenska University Hospital.","criteria":"\n        Inclusion Criteria:\r\n\r\n        Cohort number 1:Organ transplant patients who were vaccinated and serum sample drawn at\r\n        baseline.\r\n\r\n        Cohort number 2: Staff members who were vaccinated and serum sample drawn at baseline.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Cohort number 1: Organ transplant patients who were vaccinated and no serum sample drawn at\r\n        baseline.\r\n\r\n        Cohort number 2: Staff members who were vaccinated and no serum sample drawn at baseline.\r\n      ","sponsor":"Sahlgrenska University Hospital, Sweden","sponsor_type":"Other","conditions":"Organ Transplantation","interventions":[{"intervention_type":"Biological","name":"Biological: H1N1 vaccine Pandemrix"}],"outcomes":[{"outcome_type":"primary","measure":"Frequency of responders in organ transplant patients and controls"},{"outcome_type":"secondary","measure":"Frequency of >4-fold titre rise in organ transplant patients and controls"}]}
{"nct_id":"NCT00994344","start_date":"2009-10-31","phase":"Phase 4","enrollment":73,"brief_title":"Clinical Study to Evaluate the Efficacy and Safety of Lopinavir/Ritonavir Monotherapy Versus Darunavir/Ritonavir Monotherapies as Simplification Switching Strategies of PI/NNRTI-Triple Therapy Based-Regimens","official_title":"Randomised and Prospective Clinical Study to Evaluate the Efficacy and Safety of Lopinavir/Ritonavir Monotherapy Versus Darunavir/Ritonavir Monotherapies as Simplification Switching Strategies of PI/NNRTI-Triple Therapy Based-Regimens","primary_completion_date":"2012-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-10-31","last_update":"2014-02-13","description":"The purpose of this study is to determine the non-inferiority in the efficacy of DRV/r (900/100 mg) monotherapy at 48 weeks versus LPV/r (400/100 mg) as simplification strategy in subjects with sustained viral suppression on stable PI or NNRTI-antiretroviral regimens.","other_id":"LOPIDAR","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  HIV-1 infected adults (=/+18 years old).\r\n\r\n          -  Patients having a diagnosis of HIV infection, on stable HAART including:\r\n\r\n             2 NRTI/NtRTIs plus one of the following : 1 PI/ritonavir (lopinavir/ritonavir,\r\n             atazanavir/ritonavir, fosamprenavir /ritonavir, tipranavir/ritonavir,\r\n             darunavir/ritonavir) or ATV/unboosted (in a regimen without tenofovir) 1 NNRTI\r\n             (nevirapine or efavirenz), raltegravir or maraviroc\r\n\r\n          -  Undetectable plasma HIV-1 RNA (VL < 50 copies/mL) while on HAART during at least 3\r\n             month prior to switching.\r\n\r\n          -  Nadir CD4 cell count > 100 cells/mm3.\r\n\r\n          -  Absence of major PI-resistance mutations in HIV-protease (IAS 2008).20 Good treatment\r\n             adherence.\r\n\r\n          -  Voluntary written informed consent.\r\n\r\n          -  Patients and physician's preference to change the current HAART regimen for reasons of\r\n             simplification and/or toxicity.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of virological failure to a previous antiretroviral protease-containing\r\n             regimens.\r\n\r\n          -  History of virological failure defined as two consecutive plasma HIV-1 RNA > 50\r\n             copies/mL while on current antiretroviral therapy\r\n\r\n          -  Acute infections or uncontrolled chronic infection in the 2 months previous to the\r\n             inclusion or physical examination that, in the investigator's opinion, would\r\n             compromise the patient's safety or outcome of the study\r\n\r\n          -  Breastfeeding, pregnancy or fertile women willing to be pregnant.\r\n\r\n          -  Patients co-infected with hepatitis B.\r\n\r\n          -  Concomitant use of any drug with potential drug-drug interaction with DRV/r or LPV/r\r\n             at study entry.\r\n\r\n          -  Therapies including interferon, interleukin-2, cytotoxic chemotherapy or\r\n             immunosuppressors at study entry.\r\n      ","sponsor":"Germans Trias i Pujol Hospital","sponsor_type":"Other","conditions":"HIV Infections","interventions":[{"intervention_type":"Drug","name":"Drug: Darunavir/ritonavir","description":"Darunavir/ritonavir 800/100 mg once daily"},{"intervention_type":"Drug","name":"Drug: Lopinavir/ritonavir","description":"Lopinavir/ritonavir 400/100 mg twice daily"}],"outcomes":[{"outcome_type":"primary","measure":"Plasmatic HIV-1 Viral load","time_frame":"week 48"},{"outcome_type":"secondary","measure":"CD4 cell count","time_frame":"baseline, weeks 12, 24, 36, 48"},{"outcome_type":"secondary","measure":"Changes in liver enzymes (aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma GT, alkaline phosphatase)","time_frame":"baseline, weeks 12, 24, 36, 48"},{"outcome_type":"secondary","measure":"Changes in total bilirubin","time_frame":"baseline, weeks 12, 24, 36, 48"},{"outcome_type":"secondary","measure":"Changes in lipid parameters (total, HDL-, LDL-, cholesterol, triglycerides)","time_frame":"baseline, weeks 12, 24, 36, 48"},{"outcome_type":"secondary","measure":"Administration of lipid-lowering drugs throughout the study (new administrations or the withdrawal of previous lipid-lowering drugs)","time_frame":"baseline, weeks 4, 12, 24, 36, 48."},{"outcome_type":"secondary","measure":"Adverse events","time_frame":"weeks 4, 12, 24, 36, 48."},{"outcome_type":"secondary","measure":"CSF and genital tract HIV-1 viral load","time_frame":"baseline, weeks 24, 48"},{"outcome_type":"secondary","measure":"Plasmatic, CSF and genital tract trough-DRV and LPV concentration","time_frame":"weeks 12, 24, 48"},{"outcome_type":"secondary","measure":"Resistance mutations in case of confirmed virological failure (plasmatic, CSF and genital tract)","time_frame":"baseline, weeks 4, 12, 24, 36, 48."},{"outcome_type":"secondary","measure":"Neurocognitives changes","time_frame":"baseline, week 48"},{"outcome_type":"secondary","measure":"Time to virological failure, defined as an increase in HIV RNA >50 copies in 2 determinations within 1 month. The first date with VL > 50 will be used to calculate time to virological failure.","time_frame":"weeks 4, 12, 24, 36, 48."}]}
{"nct_id":"NCT00986661","start_date":"2009-10-31","phase":"Phase 1","enrollment":78,"brief_title":"A Study to Assess PV-10 Chemoablation of Cancer of the Liver","official_title":"A Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics of PV-10 Chemoablation of Cancer Metastatic to the Liver or Hepatocellular Carcinoma Not Amenable to Resection or Transplant","primary_completion_date":"2021-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2022-02-28","last_update":"2021-07-12","description":"This open-label study will evaluate the safety, tolerability, pharmacokinetics and effect on tumor growth following a single intralesional injection of PV-10 in subjects with either (a) hepatocellular carcinoma (HCC) that is not amenable to resection, transplant or other potentially curative therapy or (b) cancer metastatic to the liver.","other_id":"PV-10-LC-01","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age 18 years or older, males and females.\r\n\r\n          -  Histologically or cytologically confirmed, or clinically diagnosed based on currently\r\n             accepted standards, cancer metastatic to the liver or HCC that is not amenable at the\r\n             time of enrollment to resection, transplant or other potentially curative therapy.\r\n\r\n          -  At least one Target Lesion determined to be amenable to percutaneous injection by the\r\n             treating physician.\r\n\r\n          -  Target Lesion(s) must have measurable disease, defined as a unidimensionally\r\n             measurable lesion  1.0 cm in longest diameter by helical CT; the maximum diameter of\r\n             Target Lesion(s) shall be  4.9 cm.\r\n\r\n          -  Performance status of Karnofsky scale 60%-100% or ECOG performance scale 0-2.\r\n\r\n          -  Life expectancy  12 weeks.\r\n\r\n          -  Hematopoietic Function: WBC  2,500/mm3; ANC  1000/mm3; Hemoglobin  8 g/dL; Platelet\r\n             count  50,000/mm3; Coagulation: INR  1.3.\r\n\r\n          -  AST and ALT < 5 times ULN; ALP < 5 times ULN; Bilirubin  1.5 times ULN; Creatinine \r\n             1.5 times ULN and eGFR  50.\r\n\r\n          -  Thyroid Function: Total T3 or free T3, total T4 or free T4 and THS  CTCAE Grade 2\r\n             abnormality.\r\n\r\n          -  Renal Function: Adequate renal function in the opinion of the Investigator with no\r\n             clinically significant renal impairment or uncontrolled renal disease.\r\n\r\n          -  Cardiovascular Function: Adequate cardiovascular function in the opinion of the\r\n             Investigator with no clinically significant uncontrolled cardiovascular disease.\r\n\r\n          -  Respiratory Function: Adequate respiratory function in the opinion of the Investigator\r\n             with no clinically significant uncontrolled respiratory disease.\r\n\r\n          -  Immunological Function: Adequate immune system function in the opinion of the\r\n             Investigator with no known immunodeficiency disease.\r\n\r\n          -  Informed Consent: Signed by the subject prior to screening.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Target Lesion(s) must not be contiguous with, encompass or infiltrate major blood\r\n             vessels.\r\n\r\n          -  Primary HCC amenable to resection, transplant or other potentially curative therapy.\r\n\r\n          -  Surgery: Subjects who have received hepatic surgery, ablation or chemoembolization\r\n             within 4 weeks of PV-10 administration.\r\n\r\n          -  Radiation Therapy: Hepatic radiation within 4 weeks of PV-10 administration.\r\n\r\n          -  Chemotherapy: Chemotherapy within 4 weeks of PV-10 administration (6 weeks for\r\n             nitrosoureas or mitomycin C).\r\n\r\n          -  Investigational Agents: Investigational agents within 4 weeks (or 5 half-lives) of\r\n             PV-10 administration.\r\n\r\n          -  Phototoxic or Photosensitizing Agents: Concomitant agents posing a clinically\r\n             significant risk of photosensitivity reaction within 5 half-lives of PV-10\r\n             administration.\r\n\r\n          -  Concurrent or Intercurrent Illness: Impaired wound healing due to diabetes;\r\n             Significant concurrent or intercurrent illness, psychiatric disorders or alcohol or\r\n             chemical dependence that would compromise Subject safety or compliance or interfere\r\n             with interpretation of the study; Uncontrolled thyroid disease or cystic fibrosis;\r\n             Presence of clinically significant acute or unstable cardiovascular, cerebrovascular\r\n             (stroke), renal, gastrointestinal, pulmonary, immunological (with the exception of the\r\n             presence of hepatitis B virus (HBV), viral hepatitis, or cirrhosis), endocrine, or\r\n             central nervous system disorders; Current encephalopathy or current treatment for\r\n             encephalopathy; Variceal bleeding requiring hospitalization or transfusion within 4\r\n             months of screening; History of human immunodeficiency virus or acquired immune\r\n             deficiency syndrome; The clinical presence of ascites.\r\n\r\n          -  Pregnancy: Female subjects who are pregnant, lactating or have positive serum  HCG\r\n             pregnancy test taken within 7 days of PV-10 administration; Fertile subjects who are\r\n             not using effective contraception (e.g., oral contraceptives, intrauterine devices,\r\n             double barrier methods such as condoms and diaphragms, abstinence or equivalent\r\n             measures).\r\n      ","sponsor":"Provectus Biopharmaceuticals, Inc.","sponsor_type":"Industry","conditions":"Cancer Metastatic to the Liver|Hepatocellular Carcinoma|Metastatic Melanoma|Metastatic Ocular Melanoma|Metastatic Uveal Melanoma|Metastatic Lung Cancer|Metastatic Colon Cancer|Metastatic Colorectal Cancer|Metastatic Breast Cancer|Metastatic Pancreatic Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: PV-10 (10% rose bengal disodium)","description":"Subjects will receive a single injection of PV-10 to a single Target Lesion (0.25 mL PV-10 per cc lesion volume, Lv, or 0.50 mL PV-10 per cc Lv)."}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of hepatic administration of PV-10","time_frame":"28 days","description":"Systemic and locoregional Adverse Events (AEs) will be graded by CTCAE v4.0 and coded according to MedDRA; AE data for all subjects in the 1st cohort will be assessed prior to dose escalation. Final assessment use AE data for all subjects"},{"outcome_type":"secondary","measure":"PV-10 distribution","time_frame":"3 months","description":"Lesion distribution and retention of PV-10 following injection assessed by CT"},{"outcome_type":"secondary","measure":"Objective response rate (ORR)","time_frame":"3 months","description":"Objective response rate (ORR) of Target and measurable Bystander Lesions (if present) by 2D EASL and/or RECIST criteria"},{"outcome_type":"secondary","measure":"Changes in markers of hepatic function","time_frame":"3 months","description":"Changes in markers of hepatic function, including ALP, ALT, AST, total bilirubin"},{"outcome_type":"secondary","measure":"Pharmacokinetics of PV-10","time_frame":"28 days","description":"Pharmacokinetics of PV-10 in the bloodstream following intralesional injection; samples will be obtained immediately prior to PV-10 injection and at 2, 4, 8, 24 and 72 hours, and 7, 14 and 28 days to assess uptake and excretion of PV-10"},{"outcome_type":"secondary","measure":"Overall survival","time_frame":"Assessed every 3 months for up to 100 months","description":"Overall survival will be assessed for the intent-to-treat population"},{"outcome_type":"other","measure":"Exploratory Correlative Endpoints","time_frame":"28 days","description":"Serial correlative samples may be collected from subjects in each Expansion Cohort to evaluate potential changes in subjects' immunologic activity in response to PV-10 treatment; samples will be analyzed at one or more Sponsor-designated central laboratory"}]}
{"nct_id":"NCT00992771","start_date":"2009-10-31","phase":"Phase 2","enrollment":20,"brief_title":"Study to Determine the Safety and Tolerability of Varenicline (Chantix) in Treating Spinocerebellar Ataxia Type 3","official_title":"A Pilot, Randomized, Double-blind, Placebo-controlled Phase I Study to Determine the Safety and Tolerability of Varenicline (Chantix) in Treating Spinocerebellar Ataxia Type 3","primary_completion_date":"2011-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-04-30","last_update":"2012-06-18","description":"Spinocerebellar ataxia (SCA) is a group of inherited disorders characterized by cerebellar degeneration leading to imbalance, incoordination, speech difficulties and problems with walking. Recently, individual case reports have suggested that varenicline, a drug used in smoking cessation, produces substantial improvement in patients with several inherited ataxias. A modest response was noted in 5 patients with SCA, suggesting that it is potentially efficacious in this disorder as well. Although this agent is available for off-label use, the severe side effects noted with its use and the lack of long-term toxicity data demand that it be systematically assessed. The present study will test whether varenicline is safe and potentially efficacious in a heterogeneous cohort of adults with SCA.","other_id":"8","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Outpatients with spinocerebellar ataxia type 3 diagnosed by a movement disorder\r\n             specialist and confirmed by genetic testing (of the patient or in a first degree\r\n             relative of the patient).\r\n\r\n          2. Age 18 years to 80 years.\r\n\r\n          3. Women of child-bearing potential must use a reliable method of contraception and must\r\n             provide a negative pregnancy test at entry into the study.\r\n\r\n          4. Serum creatine kinase, complete metabolic panel, complete blood count, liver function\r\n             tests, renal function tests, platelets and EKG are within normal limits (results\r\n             obtained from primary care physician and dated within the past 6 months or obtained at\r\n             screening visit).\r\n\r\n          5. Stable doses of all medications for 30 days prior to study entry and for the duration\r\n             of the study.\r\n\r\n          6. Ability to ambulate with or without assistance.\r\n\r\n          7. Score of 10 or higher (worse) on the SARA total score.\r\n\r\n          8. Score of 3 or higher (worse) on the 'gait' subsection of the SARA rating scale.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Any unstable illness or concomitant medical condition that, in the investigator's\r\n             opinion, precludes participation in this study. This includes other disorders that may\r\n             affect gait or balance (stroke, arthritis, etc).\r\n\r\n          2. Pregnancy or lactation.\r\n\r\n          3. Concurrent participation in another clinical study.\r\n\r\n          4. Patients with a history of substance abuse.\r\n\r\n          5. Patients who currently smoke or have smoked within the past 12 months.\r\n\r\n          6. Presence of psychosis, bipolar disorder, untreated depression (BDI greater than or\r\n             equal to 21), or history of suicide attempt.\r\n\r\n          7. Concurrent treatment with any MAOIs, Wellbutrin, or nicotine patches.\r\n\r\n          8. Dementia or other psychiatric illness that prevents the patient from giving informed\r\n             consent (Mini Mental Status Exam score less than 24).\r\n\r\n          9. Legal incapacity or limited legal capacity.\r\n\r\n         10. Presence of severe renal disease (BUN 50% greater than normal or creatinine clearance\r\n             <60 mL/min) or hepatic disease.\r\n\r\n         11. Abnormal creatine kinase and/or platelet count in the past 6 months (as determined by\r\n             lab reports obtained from primary care physicians or conducted at baseline).\r\n\r\n         12. Use of varenicline within the previous 30 days.\r\n\r\n         13. Ataxia derived from any other cause than genetically-confirmed SCA (including but not\r\n             limited to alcoholism, head injury, Multiple Sclerosis, olivo-ponto-cerebellar atrophy\r\n             or multiple system atrophy).\r\n      ","sponsor":"University of South Florida","sponsor_type":"Other","conditions":"Spinocerebellar Ataxia Type 3","interventions":[{"intervention_type":"Drug","name":"Drug: varenicline","description":"up to 1mg BID for 8 weeks"},{"intervention_type":"Drug","name":"Drug: placebo","description":"placebo matching varenicline, up to 1mg BID for 8 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Frequency and severity of dose-limiting adverse events","time_frame":"25 weeks"},{"outcome_type":"secondary","measure":"The effect of varenicline on quality of life in patients with spinocerebellar ataxia","time_frame":"25 weeks"},{"outcome_type":"primary","measure":"Changes in the patient's SARA Rating Scale total score","time_frame":"25 weeks"},{"outcome_type":"secondary","measure":"The effect of varenicline on depression and anxiety ratings","time_frame":"25 weeks"},{"outcome_type":"secondary","measure":"The effect of varenicline on the activity of daily living (ADL) in patients with spinocerebellar ataxia","time_frame":"25 weeks"}]}
{"nct_id":"NCT01015274","start_date":"2009-10-31","enrollment":10,"brief_title":"Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients","official_title":"Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients","study_type":"Observational","rec_status":"Completed","last_update":"2018-07-11","description":"The long-term objective of this research is to develop a non-invasive approach for early assessment of which patients are at high risk for future development of skeletal muscle atrophy. The investigators hypothesize that the rate constant for the terminal portion of the isotope decay curve following ingestion of a single oral dose of deuterated-3-methylhistidine (D-3MH) provides an accurate measure of this increased risk and that this rate constant can be measured non-invasively from timed spot urine samples.","other_id":"09-150","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"Male","minimum_age":30,"maximum_age":75,"population":"community sample of healthy males","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male\r\n\r\n          -  30-75 years old\r\n\r\n          -  Body Mass Index (BMI) <27 kg/m2\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Uncontrolled hypertension\r\n\r\n          -  Glomerular filtration rate less than 60 mL/min/1.73 m2\r\n\r\n          -  History of recurrent gastrointestinal bleeding\r\n\r\n          -  Unable or unwilling to provide informed consent\r\n\r\n          -  Ongoing anti-coagulant therapy\r\n      ","sponsor":"The University of Texas Medical Branch, Galveston","sponsor_type":"Other","conditions":"Cachexia","interventions":{},"outcomes":{}}
{"nct_id":"NCT01051973","start_date":"2009-10-31","phase":"N/A","enrollment":200,"brief_title":"Cognitive Behavior Therapy (CBT) Compared to Stress Management for Irritable Bowel Syndrome","official_title":"Internet-delivered Cognitive Behavior Therapy Compared to Stress Management in the Treatment of Irritable Bowel Syndrome - A Randomized Controlled Study.","primary_completion_date":"2010-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-12-31","last_update":"2012-01-05","description":"The study aims to compare two manualized treatments. They are based on cognitive behavior therapy or stress management. Both treatments are delivered via an internet application and the patients' work with the treatments is supported through online contact with a therapist. The treatments last for 10 weeks. Approximately 200 patients will be included in the study and randomized to either condition. The study hypothesis is that CBT will be superior to stress management on the main outcome measure, which is IBS symptom severity measured over 4 weeks.","other_id":"IBS-X","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosis of IBS given by physician\r\n\r\n          -  At screening fulfilling Rome III-criteria for IBS\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Severe depression\r\n\r\n          -  Suicidal ideation\r\n\r\n          -  Presence of unexplained IBS alarm symptoms\r\n      ","sponsor":"Karolinska Institutet","sponsor_type":"Other","conditions":"Irritable Bowel Syndrome","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Cognitive behavior therapy","description":"A 10-week treatment based on exposure to symptoms and related feelings."},{"intervention_type":"Behavioral","name":"Behavioral: Stress management","description":"A 10-week stress management treatment including applied relaxation and dietary advice."}],"outcomes":[{"outcome_type":"secondary","measure":"Anxiety related to gastrointestinal symptoms","time_frame":"Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion","description":"Visceral Sensitivity Index"},{"outcome_type":"primary","measure":"Level of IBS symptoms","time_frame":"During 4 consecutive weeks before randomization","description":"The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment."},{"outcome_type":"primary","measure":"Level of IBS symptoms","time_frame":"During 4 consecutive weeks after treatment completion (10 weeks after randomization)","description":"The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment."},{"outcome_type":"primary","measure":"Level of IBS symptoms","time_frame":"During 4 consecutive weeks 6 months after treatment completion","description":"The Gastrointestinal symptom rating scale - IBS version. Mean of four weeks of assessment."},{"outcome_type":"secondary","measure":"Quality of life","time_frame":"Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion","description":"The Irritable Bowel Syndrome Quality of Life Instrument"},{"outcome_type":"secondary","measure":"Use of health care resources and societal production loss because of illness","time_frame":"Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion","description":"Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry"},{"outcome_type":"secondary","measure":"Level of IBS-symptoms","time_frame":"Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion","description":"IBS-Severity Scoring System"},{"outcome_type":"secondary","measure":"Level of daily stress","time_frame":"Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion","description":"Perceived stress scale"},{"outcome_type":"secondary","measure":"Subjective relief of IBS-symptoms","time_frame":"Before randomization, after treatment (10 weeks after randomization) and 6 months after treatment completion","description":"One question: \"In the past week, have you had adequate relief from IBS pain or discomfort?\""}]}
{"nct_id":"NCT00850759","start_date":"2009-10-31","phase":"Phase 3","enrollment":240,"brief_title":"Using Virtual Reality to Train Children in Pedestrian Safety","official_title":"Using Virtual Reality to Train Children in Pedestrian Safety","primary_completion_date":"2012-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-03-31","last_update":"2014-12-16","description":"Pedestrian injuries are among the leading causes of morbidity and mortality in American children ages 7-8, but existing behavior-oriented interventions achieve only modest success. One limitation to existing interventions is that they fail to provide children with the repeated practice needed to develop the complex perceptual and cognitive skills required for safe pedestrian activity. Virtual reality (VR) offers a highly promising technique to train children in pedestrian safety skills. VR permits repeated unsupervised practice without risk of injury; automated feedback to children on success or failure in crossings; adjustment of traffic density and speed to match children's skill level; and an appealing and fun environment for training. The proposed research is designed to test the efficacy of virtual reality as a tool to train child pedestrians in safe street-crossing behavior. A randomized controlled trial will be conducted with four equal-sized groups of children ages 7-8 (total N = 240). One group will receive training in an interactive and immersive virtual pedestrian environment. The virtual environment, already developed, has been demonstrated to have face, construct, and convergent validity. The second group will receive pedestrian safety training via video and computer strategies that are most widely used in American schools today. The third group will receive what is judged to be the most efficacious treatment currently available, individualized behavioral training at streetside locations. The fourth and final group will serve as a no-contact control group. All participants in all groups will be exposed to a range of field- and laboratory-based measures of pedestrian skill during baseline and post-intervention visits, as well as during a six-month follow-up assessment. Primary analyses will be conducted through linear mixed models designed to test change over time in the four intervention groups. We hypothesize all children in active learning groups will increase pedestrian safety skills, but the largest increase will be among children in the virtual reality group.","other_id":"F080715010","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":7,"maximum_age":8,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  7 and 8 year old children living in Birmingham, Alabama, area\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  family plans to move within 6 months of recruitment\r\n\r\n          -  visual or perceptual impairment (e.g., blindness) that are uncorrected and would\r\n             prevent valid participation in protocol\r\n\r\n          -  physical impairment (e.g., use of wheelchair) that would prevent valid participation\r\n             in protocol\r\n\r\n          -  cognitive impairment (e.g., moderate mental retardation) that would prevent valid\r\n             participation in protocol\r\n      ","sponsor":"University of Alabama at Birmingham","sponsor_type":"Other","conditions":"Street-crossing Ability|Pedestrian Safety","interventions":[{"intervention_type":"Device","name":"Device: virtual pedestrian environment","description":"a computer-driven virtual pedestrian environment"},{"intervention_type":"Device","name":"Device: computer and video","description":"various computer-based and video-based programs such as Otto the Auto and WalkSafe"},{"intervention_type":"Behavioral","name":"Behavioral: streetside training","description":"one-on-one training by an adult with the child at streetside locations, to teach children street-crossing skills"}],"outcomes":[{"outcome_type":"primary","measure":"Street-crossing Ability","time_frame":"post-training and again 6 months later","description":"average count of hits/close calls per participant in virtual environment, out of 30 crossings"}]}
{"nct_id":"NCT01024582","start_date":"2009-10-31","phase":"N/A","enrollment":139,"brief_title":"Radiation Therapy Followed by Surgery in Treating Patients With Early-Stage Breast Cancer","official_title":"Image Guided Preoperative Accelerated Partial Breast Irradiation (PAPBI): Defining Radiotherapy Sensitivity","primary_completion_date":"2017-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-02-28","last_update":"2017-09-27","description":"RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving CT-guided accelerated radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This clinical trial is studying giving radiation therapy followed by surgery to see how well it works in treating patients with early-stage breast cancer.","other_id":"M08PBI","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":60,"maximum_age":120,"population":"","criteria":"\n        DISEASE CHARACTERISTICS:\r\n\r\n          -  Diagnosis of unifocal cT1-2 (1-3 cm) pN0 M0 breast cancer\r\n\r\n          -  Must have undergone a sentinel node procedure prior to irradiation\r\n\r\n        PATIENT CHARACTERISTICS:\r\n\r\n          -  Not specified\r\n\r\n        PRIOR CONCURRENT THERAPY:\r\n\r\n          -  See Disease Characteristics\r\n      ","sponsor":"The Netherlands Cancer Institute","sponsor_type":"Other","conditions":"Breast Cancer","interventions":[{"intervention_type":"Procedure","name":"Procedure: biopsy","description":"before treatment a biopsy will be taken to confirm breast cancer type"},{"intervention_type":"Procedure","name":"Procedure: fine-needle aspiration","description":"at FNA tumor material will be collected and fresh frozen for micro-analyses; parafin embedded tissue will bestored for tissue-array analysis"},{"intervention_type":"Radiation","name":"Radiation: accelerated partial breast irradiation"},{"intervention_type":"Radiation","name":"Radiation: image-guided radiation therapy"}],"outcomes":[{"outcome_type":"primary","measure":"local recurrence","time_frame":"5 years","description":"Local recurrences should not exceed 4% at 5 years of follow-up"},{"outcome_type":"secondary","measure":"breast fibrosis","time_frame":"5 years","description":"decrease from 27% as found in the boost arm of the EORTC boost-no boost trial to 15%"},{"outcome_type":"secondary","measure":"cosmetic outcome","time_frame":"5 years","description":"is anticipated that the overall score for cosmetic outcome will be superior compared to conventional whole breast postoperative radiotherapy plus boost."},{"outcome_type":"secondary","measure":"Pathological response","time_frame":"6 weeks after finishing iradiation treatment"}]}
{"nct_id":"NCT00999050","start_date":"2009-10-31","phase":"N/A","enrollment":50,"brief_title":"Laparoscopic Gastric Bypass for Type 2 Diabetes Mellitus With Body Mass Index (BMI) < 35","official_title":"Laparoscopic Gastric Bypass for Type 2 Diabetes Mellitus: a Pilot Prospective Study in Overweight and Mildly Obese Subjects","primary_completion_date":"2011-10-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2013-11-30","last_update":"2011-01-04","description":"The aim of this study is to evaluate the effect of Roux-en-y gastric bypass (RYGB) in controlling diabetes in subjects with mild obesity (BMI 26-35). The primary endpoint will be the reduction of HbA1c (< 7%), a standard measure of diabetes control; the secondary endpoints will be changes blood sugar , vitamin levels, insulin, c-peptide, and lipids levels, as well as retinal eye examinations, urinalysis to assess kidney function, carotid ultrasound as a marker of cardiovascular function, and alterations in diabetic medications. Fifty subjects with medically documented type 2 Diabetes Mellitus (T2DM) with BMIs between 26 and 35 will undergo standard laparoscopic RYGB. Prior and after surgery, the subjects will undergo a clinical evaluation in regard to the primary and secondary endpoints listed. The pre-surgery evaluation is directed toward establishing the existence of diabetes related complications prior to surgery. After surgery subjects will be closely monitored for complications and required changes in their diabetes management. Repeat assessments will be made at 1, 3, 6, and 12 months and at two years.","other_id":"0906010450","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Adult males and females who meet the following inclusion criteria will be offered the\r\n        opportunity to participate in the study:\r\n\r\n          1. Diagnosis of type 2 Diabetes Mellitus (T2DM) confirmed by the following criteria:\r\n\r\n               1. normal or high C-peptide level (> 0.9 ng/ml) to exclude type 1 Diabetes Mellitus\r\n\r\n               2. positive glucagon test to confirm T2DM\r\n\r\n               3. fasting plasma glucose of 126 mg/dl or more on at least two occasions\r\n\r\n          2. Body mass index (BMI) 26 kg/m2 or greater, and less than 35 kg/m2\r\n\r\n          3. History of T2DM for not longer than 8 years, as long-standing disease beyond 8 years\r\n             correlates with failure to achieve diabetes resolution after gastric bypass\r\n\r\n          4. No contraindication for surgery or general anesthesia as determined by a\r\n             multidisciplinary bariatric surgery team (surgeon, anesthesiologist, internist,\r\n             dietitian, psychologist)\r\n\r\n          5. Between 18 and 65 year of age\r\n\r\n          6. Able to provide informed consent\r\n\r\n          7. If a female with reproductive potential, she has to agree to use a reliable method of\r\n             birth control for at least one year from the date of surgery\r\n\r\n        Exclusion Criteria\r\n\r\n        Subjects who meet any of the following exclusion criteria will not be eligible to\r\n        participate in the study:\r\n\r\n          1. Enrollment in another clinical study, which involves an investigational drug\r\n\r\n          2. Diagnosis of type 1 Diabetes Mellitus or other genetic forms of Diabetes Mellitus\r\n\r\n          3. Significant renal failure of chronic liver disease (except NAFLD)\r\n\r\n          4. Major psychological disorders\r\n\r\n          5. Pregnancy - all female subjects will have serum beta-hCG prior to operation, and must\r\n             use birth control of their choice to avoid pregnancy during the first year after\r\n             surgery\r\n\r\n          6. Previous gastric or esophageal surgery\r\n\r\n          7. Immunosuppressive drugs including corticosteroids\r\n\r\n          8. Coagulopathy defined as an INR > 1.5 or platelet count < 50,000/l\r\n\r\n          9. Anemia defined as a Hb <10.0 g/dl\r\n\r\n         10. Inflammatory bowel diseases or other medical condition that would serve as a\r\n             contraindication to gastric bypass (eg. celiac sprue, pancreatic insufficiency)\r\n\r\n         11. A severe concurrent illness that is likely to limit life or require extensive systemic\r\n             treatment (e.g. cancer)\r\n\r\n         12. A pre-existing major complication of diabetes:\r\n\r\n               1. unstable, proliferative retinopathy\r\n\r\n               2. severe autonomic cardiac neuropathy or intestinal neuropathy\r\n\r\n               3. Myocardial infarction within the previous year, current unstable angina, or\r\n                  poorly-controlled congestive heart failure (Stage III)\r\n      ","sponsor":"Weill Medical College of Cornell University","sponsor_type":"Other","conditions":"Diabetes Mellitus, Type 2","interventions":[{"intervention_type":"Procedure","name":"Procedure: Gastric bypass for diabetic patients <35 BMI","description":"The operation is performed under general anesthesia. It is done laparoscopically, meaning that several small openings are made in the abdomen for insertion of long, thin surgical instruments, one with an attached camera. The operation is video monitored. The top of the stomach is divided across, leaving a small pouch for food. The rest of the stomach remains but can receive no food. The gut is divided just past the stomach, and it is attached to the small stomach pouch so that food can get back into the bowel. A second connection is made so that the bile and digestive juices pass into the bowel with the food."}],"outcomes":[{"outcome_type":"primary","measure":"Hemoglobin A1C changes","time_frame":"Post gastric bypass operation"},{"outcome_type":"secondary","measure":"improvement in glycemic control","time_frame":"1 to two years"}]}
{"nct_id":"NCT01268254","start_date":"2009-10-31","enrollment":200,"brief_title":"Red Wine and Ageing and Atherosclerosis","official_title":"The Red Wine Project: a Study of Ageing Indexes and Prevalence of Atherosclerosis in Regular Red Wine Consumers Versus Abstainers","primary_completion_date":"2011-03-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2011-04-30","last_update":"2010-12-29","description":"The investigators will evaluate 100 regular red wine consumer men and 100 abstainers men from 50 years-old to 70 years-old by coronary risk prevalence, mood status, anthropometric measures, daily caloric ingest, lipid profile, carotid intimal media thickness, brachial flow mediate dilatation, coronary tomographic angiography and leucocyte telomere length. The sample size has been calculated expecting that regular red wine ingestion would lead to a five year old younger vascular ageing indexes measured by carotid intimal media thickness, coronary artery calcium scores and leucocyte telomere length longer than those abstainers subjects at same age. The investigators hypothesized that regular wine consumers present less coronary lesion and coronary calcium score on coronary tomographic angiography, lower carotid intimal media thickness and higher mean telomere length due the benefice of wine.","other_id":"1-48200805","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"Male","minimum_age":50,"maximum_age":70,"population":"male subjects, between 50 years-old and 70 years-old, divided in 2 groups: usual red wine\r\n        consumers and red wine abstemious","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  healthy male, from 50 years-old to 70 years-old.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  asiatic or with manifest atherosclerosis disease\r\n      ","sponsor":"University of Sao Paulo","sponsor_type":"Other","conditions":"Coronary Disease","interventions":{},"outcomes":{}}
{"nct_id":"NCT00896389","start_date":"2009-10-31","phase":"Phase 4","enrollment":124,"brief_title":"Salt Loading and Thiazide Intervention Study","official_title":"The Relationship Between Serine Threonine Kinase 39 (STK39) Genotypes, Salt Sensitivity, Thiazide Diuretics-induced Blood Pressure Response","primary_completion_date":"2012-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-03-31","last_update":"2019-11-05","description":"The investigators of this study propose to examine the relationships between STK39 (Serine Threonine Kinase 39) genotypes and responses to salt loading and to thiazide diuretics, hydrochlorothiazide. The investigators hypothesize that STK39 genotypes will be associated with the outcome of both interventions and can contribute to personalized care for hypertension.","other_id":"HP-00040712","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Old Order Amish\r\n\r\n          -  Age 18 to 65\r\n\r\n          -  Have systolic blood pressure between 120 and 160 and diastolic blood pressure between\r\n             80 and 100\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of myocardial infarction, stroke, congestive heart failure, liver disease\r\n\r\n          -  Known cause of secondary hypertension\r\n\r\n          -  Diabetes or Fasting glucose > 100 mg/dL\r\n\r\n          -  Women who are pregnant, on oral contraceptives, or menstruating\r\n\r\n          -  Used hydrochlorothiazide (HCTZ) in the last 8 weeks or known allergy to HCTZ\r\n\r\n          -  Taking non-steroidal anti-inflammatory drugs\r\n\r\n          -  Estimated glomerular filtration rate < 80 mL/m\r\n\r\n          -  Intention to alter dietary habit during the study\r\n\r\n          -  Abuse of alcohol or drug\r\n      ","sponsor":"University of Maryland, Baltimore","sponsor_type":"Other","conditions":"Hypertension","interventions":[{"intervention_type":"Procedure","name":"Procedure: Salt loading","description":"Subjects will arrive at the Amish Research Clinics after overnight fasting. After taking height, weight, BP, and body temperature, subjects will receive 2 liters (L) of 0.9% sodium chloride (NaCl) saline over 4 hours while their blood pressure is monitored every 15 minutes. Blood pressure will be taken every 15 minutes during this procedure. Blood and urine samples will be collected from all subjects pre- and post-infusion."},{"intervention_type":"Drug","name":"Drug: Hydrochlorothiazide (HCTZ)","description":"We will perform short-term HCTZ intervention on the same 120 subjects. After overnight fasting and having their height, weight, and BP measured, subjects are given seven 12.5 mg HCTZ tablets and instructed to take 1 tablet daily for one week. Ambulatory blood pressure will be measured and blood and urine will be collected on both day 1 and day 8. After a minimum 6-week wash-out period, the subjects will repeat the 7-day HCTZ intervention, taking 25 mg of HCTZ instead. Subjects with plasma potassium levels below 3.6 mmol/L on day 8 of 12.5 mg HCTZ will be given a daily supplement of 16 milliequivalents of potassium to prevent harmful loss of potassium while taking HCTZ."}],"outcomes":[{"outcome_type":"primary","measure":"Blood Pressure Change During Salt Loading","time_frame":"Every 15 minutes for 4 hours","description":"Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured every 15 minutes for 4 hours.\r\nBlood pressure change is calculated by the trapezoid method. Essentially we use the average of blood pressure at each pair of time points (for example, DBP 30min + DBP 15min)/2 + (DBP 45min + DBP 30min)/2 + … up to 4 hours.) normalized by baseline SBP/DBP."},{"outcome_type":"primary","measure":"Blood Pressure Change After 7 Days of Low Dose (12.5 mg) of HCTZ","time_frame":"24-hr Ambulatory blood pressure were measured every hour on day 0 and day 8","description":"Blood pressure change is defined as SBP or DBP average over the 24 hour period, Day 8 subtracts Day 0."},{"outcome_type":"primary","measure":"Blood Pressure Change After 7 Days of High Dose (25 mg) of HCTZ","time_frame":"24-hr Ambulatory blood pressure were measured every hour on day 0 and day 8","description":"Blood pressure change is defined as SBP or DBP average over the 24 hour period, Day 8 subtracts Day 0."},{"outcome_type":"primary","measure":"Fasting Glucose Change After 7 Days of Low Dose (12.5 mg) of HCTZ","time_frame":"Fasting glucose was measured on day 0 and day 8","description":"Values on Day 8 subtracts Day 0."},{"outcome_type":"primary","measure":"Fasting Glucose Change After 7 Days of High Dose (25mg) of HCTZ","time_frame":"Fasting glucose was measured on day 0 and day 8","description":"Values on Day 8 subtracts Day 0."},{"outcome_type":"secondary","measure":"Change in Plasma Aldosterone Level Due to Salt-loading","time_frame":"Aldosterone was measured from blood collected pre and post salt loading","description":"Aldosterone is a hormone that plays a critical role in homeostatic regulation of blood pressure. Change is defined as the post-salt loading values minus the pre-salt loading values"},{"outcome_type":"secondary","measure":"Change in Plasma Renin Activity Due to Salt-loading","time_frame":"Renin was measured from blood collected pre and post salt loading","description":"Renin is an enzyme that mediates extracellular fluid and regulates blood pressure. Plasma renin activity (PRA) is a measure of the activity of the plasma enzyme renin. PRA is measured in the laboratory by incubating plasma at physiologic temperature in a buffer that facilitates its enzymatic activity. The natural substrate for the enzyme renin is angiotensinogen. Exogenous angiotensinogen is not added to the reaction mixture. This means that, in effect, the PRA results reported are dependent on both renin concentration and the concentration of its substrate in the patient's plasma. Renin cleaves angiotensinogen to produce a decapeptide, angiotensin I, the concentration of which is assayed using liquid chromatography accompanied by tandem mass spectroscopic detection (LC/MS/MS). PRA levels are reported as the amount of angiotensin I generated per unit of time. Change is defined as the post-salt loading values minus the pre-salt loading values"},{"outcome_type":"secondary","measure":"Change in Plasma Sodium/Potassium Level Due to Salt-loading","time_frame":"Plasma sodium and potassium measured from blood collected pre and post salt loading","description":"Na/K ratio is a function of kidney function"},{"outcome_type":"secondary","measure":"Change in Plasma Sodium/Potassium Level During Low Dose of HCTZ","time_frame":"Plasma sodium and potassium measured from blood collected pre and post salt loading","description":"Na/K ratio is a function of kidney function"},{"outcome_type":"secondary","measure":"Change in Plasma Sodium/Potassium Level During High Dose of HCTZ","time_frame":"Plasma sodium and potassium measured from blood collected pre and post salt loading","description":"Na/K ratio is a function of kidney function"}]}
{"nct_id":"NCT00289471","start_date":"2009-10-31","enrollment":630,"brief_title":"Identifying Patients With Dementia in Primary Care","official_title":"Dementia in Primary Care: Setting the Stage for Quality Improvement","primary_completion_date":"2009-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2010-10-31","last_update":"2015-05-01","description":"Veterans who completed GEMS-Phase 1 will be asked to participate in GEMS-Phase 2 to determine the accuracy of methods used to assess mild memory problems. This will better help us evaluate the screening test completed in GEMS-Phase 1. The goals are: 1. Compare the assessment of memory made at the initial visit to assessments of memory made at the second evaluation. 2. Determine of veterans with mild memory problems have improvement or worsening of these memory problems over time. Our long-term goal remains to optimize the quality of care for veterans with cognitive impairment. We will also determine if patient characteristics can be used to target case-finding, describe the current process of care and evaluate the association between cognitive impairment and overall- and dementia-related health care utilization and costs.","other_id":"IIR 05-112","time_perspective":"Cross-Sectional","sampling_method":"Probability Sample","gender":"All","minimum_age":65,"population":"Veterans' who have previously completed GEMS-Phase 1 testing, continues to be a VA clinic\r\n        patient and identifies a key family member or friend who will answer questions about the\r\n        veteran's memory and daily activities.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Previous participant who completed GEMS-Phase 1\r\n\r\n          -  Continues to be a VA clinic patient\r\n\r\n          -  Identifies a key informant with phone\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Severe hearing or visual impairment\r\n\r\n          -  Acute medical condition\r\n      ","sponsor":"US Department of Veterans Affairs","sponsor_type":"U.S. Fed","conditions":"Dementia|Memory Disorders","interventions":[{"intervention_type":"Other","name":"Other: No intervention delivered.","description":"No intervention delivered."}],"outcomes":[{"outcome_type":"primary","measure":"Performance Characteristics","time_frame":"Cross-sectional [at baseline; no longitudinal component]","description":"Sensitivity and Specificity for Modified Mini-Mental Status Examination (MMSE), a measure scored 0-100 to assess cognitive impairment"}]}
{"nct_id":"NCT01055548","start_date":"2009-10-31","enrollment":20,"brief_title":"PPrime: Parents Views on Diagnosis and Information-giving in Neonatal Care (Pilot Study)","official_title":"Parents Views on Diagnosis and Information-giving in Neonatal Care (Pilot Study)","primary_completion_date":"2009-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2009-12-31","last_update":"2015-06-03","description":"The aim of the pilot study is to explore and identify the issues of concern to parents whose babies have been cared for in a neonatal unit and exposed to imaging, its influence on diagnosis and information-giving process","other_id":"EudraCT 2009-0138888-19","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","maximum_age":0.63462,"population":"Parents of babies born before 33 week's gestation","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Parents of babies born before 33 weeks gestation Parents who are 16 years of age or\r\n             older Parents who are able to give informed consent Parents who are able to take part\r\n             in interviews which are conducted in English\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Parents who are under 16 years of age Parents who are unable to give informed consent\r\n             Parents who are unable to take part in interviews which are conducted in English\r\n             Parents where there are possible or know child protection issues\r\n      ","sponsor":"Imperial College London","sponsor_type":"Other","conditions":"Parents of Preterm Infants Born Before 33 Weeks Gestation","interventions":{},"outcomes":{}}
{"nct_id":"NCT01006603","start_date":"2009-10-31","phase":"Phase 4","enrollment":957,"brief_title":"Saxagliptin Compared to Glimepiride in Elderly Type 2 Diabetes Patients, With Inadequate Glycemic Control on Metformin","official_title":"A 52-Week, Randomised, Double Blind, Active-Controlled, Multi-Centre Phase IIIb/IV Study to Evaluate the Efficacy and Tolerability of Saxagliptin Compared to Glimepiride in Elderly Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycaemic Control on Metformin Monotherapy","primary_completion_date":"2012-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-06-30","last_update":"2013-11-28","description":"This study will evaluate the efficacy and tolerability of saxagliptin compared to glimepiride in elderly patients with type 2 diabetes mellitus who have inadequate glycaemic control on metformin monotherapy.","other_id":"D1680L00002","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Provision of informed consent prior to any study specific procedures\r\n\r\n          -  Established clinical diagnosis of type 2 diabetes. Treatment with a stable metformin\r\n             monotherapy, for at least 8 weeks prior to Visit 1\r\n\r\n          -  HbA1c 7.0% and 9.0%\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketonic coma.\r\n             Current use of any injectable or oral antihyperglycemic agent excluding metformin.\r\n\r\n          -  Renal impairment as defined by a creatinine clearance <60 mL/min\r\n\r\n          -  Individuals who, in the opinion of the investigator, in which participation in this\r\n             study may pose a significant risk to the patient and could render the patient unable\r\n             to successfully complete the study\r\n      ","sponsor":"AstraZeneca","sponsor_type":"Industry","conditions":"Type 2 Diabetes Mellitus","interventions":[{"intervention_type":"Drug","name":"Drug: Saxagliptin","description":"5 mg, oral tablet, once daily"},{"intervention_type":"Drug","name":"Drug: Glimepiride","description":"1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily"}],"outcomes":[{"outcome_type":"primary","measure":"Proportion of Patients Reaching HbA1c <7% After 52 Weeks of Treatment Without Confirmed or Severe Hypoglycaemia.","time_frame":"From week 0 to week 52.","description":"Defined as obtained on or before the 8th day after the last dosing day, as determined by central laboratory. Safety analysis set.\r\nConfirmed hypoglycaemia defined as: any event defined as either a symptomatic event with blood glucose level <3 mmol/L (<54 mg/dL) and no need for external assistance, or an asymptomatic blood glucose measurement <3 mmol/L (<54 mg/dL).\r\nMajor (or severe) hypoglycaemia defined as: symptomatic events requiring external assistance due to severe impairment in consciousness or behaviour, with or without blood glucose level <3 mmol/L (<54 mg/dL), but with prompt recovery after glucose or glucagon administration. These events may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery, attributable to the restoration of plasma glucose to normal, was considered sufficient evidence that the event was induced by a low plasma glucose concentration."},{"outcome_type":"secondary","measure":"Proportion of Patients Having Experienced at Least One Hypoglycaemic Event (Confirmed or Severe) Over the 52-week Double-blind Treatment Period.","time_frame":"From week 0 to week 52.","description":"Hypoglyceamic event defined as, Confirmed hypoglycaemia: any event defined as either a symptomatic event with blood glucose level <3 mmol/L (<54 mg/dL) and no need for external assistance, or an asymptomatic blood glucose measurement <3 mmol/L (<54 mg/dL).\r\nMajor (or severe) hypoglycaemia: symptomatic events requiring external assistance due to severe impairment in consciousness or behaviour, with or without blood glucose level <3 mmol/L (<54 mg/dL), but with prompt recovery after glucose or glucagon administration. These events may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery, attributable to the restoration of plasma glucose to normal, was considered sufficient evidence that the event was induced by a low plasma glucose concentration. Safety analysis set."},{"outcome_type":"secondary","measure":"Change From Baseline to Week 52 in HbA1c.","time_frame":"From week 0 to week 52.","description":"Measured as the difference between the last on-treatment value (defined as obtained before or on the 8th day after the last dosing date), and the last pre-randomisation HbA1c value, as determined by central laboratory. Full analysis set."},{"outcome_type":"secondary","measure":"Proportion of Patients Achieving a Therapeutic Glycaemic Response at Week 52 Defined as HbA1c <7.0%","time_frame":"From week 0 to week 52","description":"Proportion of patients with their last on-treatment value (defined as obtained before or on the 8th day after the last dosing date), as determined by central laboratory, below the specified limits. Full analysis set."},{"outcome_type":"secondary","measure":"Change From Baseline to Week 52 in Fasting Plasma Glucose (FPG)","time_frame":"From week 0 to week 52","description":"Measured as the difference between the last on-treatment value (defined as obtained before or on the first day after the last dosing date)and the last pre-randomisation fasting plasma glucose value, as determined by central laboratory. Full analysis set."},{"outcome_type":"secondary","measure":"Change From Baseline to Week 52 in Insulin","time_frame":"From week 0 to week 52","description":"Measured as the difference between the last on-treatment value (defined as obtained before or on the first day after the last dosing date) and the last pre-randomisation fasting plasma insulin value, as determined by central laboratory. Full analysis set."},{"outcome_type":"secondary","measure":"Change From Baseline to Week 52 in β-cell Function (as Measured by Homeostasis Model Assessment-β [HOMA-β]","time_frame":"From week 0 to week 52","description":"β-cell function as estimated by the homeostasis model assessment (HOMA) model. Value is derived from FPG and fasting insulin; fasting insulin values below 2.074 μU/mL or above 57.595 μU/mL and FPG values below 3 mmol/L or above 25 mmol/L are excluded (as restricted by the calculation method used). Full analysis set."}]}
{"nct_id":"NCT01118494","start_date":"2009-09-30","enrollment":400,"brief_title":"Study of Urinary Angiotensinogen as a Marker to Warn the Deterioration of Renal Function in CKD Patients Early.","primary_completion_date":"2010-02-28","study_type":"Observational","rec_status":"Unknown status","completion_date":"2011-06-30","last_update":"2010-05-06","description":"Chronic kidney disease (CKD) that results in end-stage renal disease (ESRD) is a major international health problem. Many clinical markers such as urine protein or eGFR(evaluated glomerular filtration rate),can estimate the renal function, but not sensitive. As well-known, the crucial role of angiotensin II (AngII), the major effector of the renin-angiotensin system (RAS), in the development of renal fibrosis that results in ESRD is widely recognized.Abundant researches find that intrarenal RAS takes an important role on the progression of CKD. At present, no clinical marker is available to evaluate intrarenal AngII activity because it is difficult to measure it directly in patients. So find and establish a bio-marker of local renal RAS activation maybe a breakthrough in early detection and treatment of CKD. Angiotensinogen(AGT) is the only known substrate for renin and the level of AGT in humans is close to Km value for renin. Thus , changes in AGT levels can control the activity of the RAS, and its up-regulation may lead to activity of Ang levels. Then we hypothesis that the AGT is a early bio-marker of local renal RAS activation as well as CKD.","other_id":"08dz1900603","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":80,"population":"CKDchronic kidney diseasein the stage of 3 or 4.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  CKD, in the stage of 3 or 4, and kidney biopsy is preferred selection;\r\n\r\n          -  Signed the informed consent;\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Kidney cancer patients;\r\n\r\n          -  Kidney transplantation;\r\n\r\n          -  Hereditary kidney disease;\r\n\r\n          -  Secondary renal disease(diabetic nephropathy and hypertensive nephropathy are\r\n             excluded)\r\n      ","sponsor":"Fudan University","sponsor_type":"Other","conditions":"Chronic Kidney Disease|Urinary Angiotensinogen","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Urinary AGT level","time_frame":"12 months","description":"Urinary AGT level can be an early bio-marker of intrarenal RAS activation and prewarning the deterioration of renal function."}]}
{"nct_id":"NCT01568424","start_date":"2009-09-30","phase":"N/A","enrollment":25,"brief_title":"CentriMag RVAS U.S. Post-approval Study Protocol","official_title":"CentriMag RVAS U.S. Post-approval Study Protocol","primary_completion_date":"2014-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-06-30","last_update":"2019-01-30","description":"The study objective is to gather post-market clinical data on the use of the CentriMag RVAS when used for temporary mechanical circulatory support of the right ventricle in patients with acute right ventricular failure from any cause","other_id":"TC10152008","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Right ventricular failure from any cause\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Primary coagulopathy or platelet disorders\r\n\r\n          -  Allergy or sensitivity to heparin and all alternative anticoagulants\r\n      ","sponsor":"Abbott Medical Devices","sponsor_type":"Industry","conditions":"Right Ventricular Failure","interventions":[{"intervention_type":"Device","name":"Device: CentriMag RVAS placement","description":"Patients will be treated with a CentriMag RVAS"}],"outcomes":[{"outcome_type":"primary","measure":"Survival","time_frame":"30 days post device removal","description":"In patients who recover and do not go on to transplantation or a long-term device: Survival to 30 days post-support or to hospital discharge (whichever is longer).\r\nIn patients who do not recover and are bridged to transplant or a long-term system: Survival to induction of anesthesia for implantation of a long-term device or heart transplant."},{"outcome_type":"secondary","measure":"Central Venous Pressure (CVP)","time_frame":"Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal","description":"CVP is a measure of right heart filling pressure, or the preload to the right ventricle. During RVAD support, the CVP decreases as blood is drawn into the pump and then ejected into the pulmonary artery."},{"outcome_type":"secondary","measure":"Mean Arterial Pressure (MAP)","time_frame":"Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal.","description":"MAP is the mean value for the blood pressure in the arterial circulation. During RVAD support, this value provides information regarding the adequacy of cardiac output from the left ventricle."},{"outcome_type":"secondary","measure":"Cardiac Index (CI)","time_frame":"Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal.","description":"Cardiac output (L/min) divided by the body surface area (m2)"},{"outcome_type":"secondary","measure":"Blood Urea Nitrogen (BUN)","time_frame":"Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal, 30 days after RVAD removal","description":"BUN is a measure of renal function"},{"outcome_type":"secondary","measure":"Creatinine","time_frame":"Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal, 30 days after RVAD removal","description":"Creatinine is a measure of renal function"},{"outcome_type":"secondary","measure":"Total Bilirubin","time_frame":"Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal, 30 days after RVAD removal","description":"Total bilirubin is a measure of hepatic function"}]}
{"nct_id":"NCT00976963","start_date":"2009-09-30","phase":"N/A","enrollment":300,"brief_title":"Single Dose Monurol for Treatment of Acute Cystitis","official_title":"Single Dose Monurol for Treatment of Acute Cystitis","primary_completion_date":"2017-06-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2018-05-30","last_update":"2017-11-17","description":"Urinary tract infecton (UTI) is a very common problem in young healthy women, afflicting approximately one-half of women by their late 20's. One of the most common antibiotics used to treat UTIs is Trimethoprim-sulfa (TMP-SMX), usually for total of three days. However, concerns about increased antibiotic resistance have led to increased interest in studying other antibiotics for UTI. An alternative antibiotic which is also FDA approved for the treatment of UTIs is fosfomycin (Monurol). The effectiveness of fosfomycin in curing UTIs when given as a single dose is not well studied. The purpose of this research study is to determine what the cure rates are with a single dose of fosfomycin versus the more standard 3-day course of TMP-SMX.","other_id":"34776","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Non pregnant women in good health with symptoms of acute cystitis for less than 7 days\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnant, lactating, or not regularly contracepting\r\n\r\n          -  History of chronic conditions such as diabetes\r\n\r\n          -  Known anatomic abnormalities of the urinary tract\r\n\r\n          -  Use of prophylactic antibiotics\r\n\r\n          -  History of allergy or intolerance to any of the study drugs\r\n\r\n          -  Recent (> 2 weeks)exposure to oral or parenteral antimicrobial\r\n\r\n          -  History of UTI in previous 1 month\r\n      ","sponsor":"University of Washington","sponsor_type":"Other","conditions":"Urinary Tract Infection","interventions":[{"intervention_type":"Drug","name":"Drug: Fosfomycin","description":"3g sachet single dose"},{"intervention_type":"Drug","name":"Drug: TMP/SMX DS","description":"160/800mg BID x 3 days"}],"outcomes":[{"outcome_type":"primary","measure":"To assess the efficacy of a single dose fosfomycin","time_frame":"28-30 post therapy"},{"outcome_type":"secondary","measure":"To assess the tolerance of a single does of fosfomycin","time_frame":"28-30 days post therapy"}]}
{"nct_id":"NCT00910845","start_date":"2009-09-30","phase":"Phase 3","enrollment":557,"brief_title":"Study of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence","primary_completion_date":"2011-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-07-31","last_update":"2013-03-05","description":"The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A (onabotulinumtoxinA) in treating patients with idiopathic overactive bladder with urinary incontinence.","other_id":"191622-095","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Symptoms of OAB (frequency/urgency) with urinary incontinence for at least 6 months\r\n\r\n          -  Inadequate response or limiting side effects with anticholinergics for the treatment\r\n             of OAB\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Overactive Bladder caused by neurological condition\r\n\r\n          -  Patient has predominance of stress incontinence\r\n\r\n          -  History or evidence of pelvic or urological abnormality\r\n      ","sponsor":"Allergan","sponsor_type":"Industry","conditions":"Overactive Bladder","interventions":[{"intervention_type":"Biological","name":"Biological: onabotulinumtoxinA","description":"OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable). Or, if placebo is administered at Day 1, onabotulinumtoxinA 100 U injected after a minimum of 12 weeks (if applicable)."},{"intervention_type":"Drug","name":"Drug: normal saline","description":"Normal saline (placebo) injected into the detrusor at Day 1."}],"outcomes":[{"outcome_type":"primary","measure":"Change From Baseline in Number of Daily Episodes of Urinary Incontinence","time_frame":"Baseline, Week 12","description":"A urinary incontinence episode is defined as an incident of involuntary loss of urine as recorded in a patient bladder diary during the 3 days before the Baseline and Week 12 study visits. A negative number change from baseline indicates a reduction in incontinence episodes (improvement)."},{"outcome_type":"secondary","measure":"Change From Baseline in Number of Daily Micturition Episodes","time_frame":"Baseline, Week 12","description":"The number of micturition episodes (the number of times a patient urinates into the toilet) was recorded by the patient in a bladder diary during 3 consecutive days in the week prior to the Baseline and prior to the Week 12 study visit. A negative number change from baseline indicates a reduction in micturition episodes (improvement)."},{"outcome_type":"secondary","measure":"Change From Baseline in Volume Voided Per Micturition","time_frame":"Baseline, Week 12","description":"The total volume voided was measured over one 24-hour period in the week prior to the Baseline and Week 12 study visit and recorded by the patient in the bladder diary. This was used to calculate volume voided per micturition. A positive number change from baseline indicates an increase in volume voided per micturition (improvement)."}]}
{"nct_id":"NCT03634137","start_date":"2009-09-30","phase":"Phase 1","enrollment":24,"brief_title":"Implant Pharmacokinetic and Pharmacodynamic Study","official_title":"A Phase Ib Study to Confirm the Pharmacokinetics and Melanogenic Potential of Controlled-Release Bioresorbable Implants of Afamelanotide in Healthy Volunteers","primary_completion_date":"2010-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-03-31","last_update":"2018-08-16","description":"This is a single center, pharmacokinetic and pharmacodynamic study in healthy volunteers. Twenty four subjects will be enrolled in the study and will be assigned to receive either a 16 mg afamelanotide bioresorbable implant from the current manufacturing process or a 16 mg afamelanotide bioresorbable implant from the optimized manufacturing process. Implants will be administered subcutaneously. The following procedures will be conducted throughout the study: - Collection of blood samples for analysis of afamelanotide concentrations - Measurement of skin reflectance for estimation of melanin density, and luminance (L*), blue/yellow colour hue (b*) - Safety monitoring","other_id":"CUV028","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","intervention_model_description":"Participants were assigned to receive either a 16 mg bioresorbable afamelanotide implant from the previous manufacturing process or a 16 mg bioresorbable afamelanotide implant from the optimized final manufacturing process.","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy Caucasian adults aged between 18 and 45 years (inclusive).\r\n\r\n          -  Free of significant abnormal findings as determined during the screening procedure by\r\n             surgical and medical history, physical examination, ECG, clinical laboratory testing\r\n             and vital signs.\r\n\r\n          -  BMI between 18 and 30 kg/m2 (inclusive).\r\n\r\n          -  No history of drug abuse, licit or illicit (including alcohol).\r\n\r\n          -  Agree not to use any medications (prescribed medicines, over-the-counter medications,\r\n             dietary supplements or nutraceuticals) without pre-approval by the Principal\r\n             Investigator or nominee during the 7 days preceding the study, and during the course\r\n             of the study (until Day 60)\r\n\r\n          -  Willing to take precautions to prevent pregnancy until completion of the study (Day\r\n             60).\r\n\r\n          -  Able to understand and sign the written Informed Consent Form.\r\n\r\n          -  Able and willing to follow the Protocol requirements, including refraining from the\r\n             use of melanogenic (tanning) products and recreational sun or UV light exposure from\r\n             the start of the study until Day 60\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any significant history of allergy and/or sensitivity to any of the contents of study\r\n             drug product.\r\n\r\n          -  Any significant history of allergy and/or sensitivity to lignocaine or other local\r\n             anaesthetic.\r\n\r\n          -  Any evidence of organ dysfunction or any clinically significant deviation from normal\r\n             in the physical or clinical determinations.\r\n\r\n          -  Personal history of melanoma, dysplastic nevus syndrome or family history of melanoma\r\n             in a first degree relative.\r\n\r\n          -  Any evidence at the screening medical examination of hypertension or hypotension.\r\n             Hypertension is defined as three separate readings that persistently read over 140/90\r\n             mmHg systolic/diastolic. Hypotension is defined as three separate readings that\r\n             persistently read under 90/50 mmHg systolic/diastolic.\r\n\r\n          -  A pulse rate of less than 50 beats/minute.\r\n\r\n          -  Any significant illness during the 4 weeks before the study screening period.\r\n\r\n          -  Any contraindication to blood sampling.\r\n\r\n          -  Any factor that may interfere with the skin reflectance measurements (e.g. vitiligo,\r\n             albinism, excessive number of moles, or excessively hairy skin).\r\n\r\n          -  Positive screening urine drugs of abuse test.\r\n\r\n          -  Participation in any clinical study during the 4 weeks before the study screening\r\n             period.\r\n\r\n          -  Has donated 400 mL or more of blood or had significant blood loss during the 8 weeks\r\n             preceding screening.\r\n\r\n          -  Has donated plasma within the 7 days preceding screening.\r\n\r\n          -  Have consumed alcohol during the 24 hours prior to Day 1\r\n      ","sponsor":"Clinuvel Pharmaceuticals Limited","sponsor_type":"Industry","conditions":"Healthy","interventions":[{"intervention_type":"Drug","name":"Drug: Afamelanotide Group 1","description":"One 16 mg bioresorbable afamelanotide implant (Group 1) from the previous manufacturing process."},{"intervention_type":"Drug","name":"Drug: Afamelanotide Group 2","description":"One 16 mg bioresorbable afamelanotide implant (Group 2) from the optimized final manufacturing process."}],"outcomes":[{"outcome_type":"primary","measure":"Change in skin melanin density","time_frame":"120 days","description":"To confirm serial changes in skin melanin density by reflectance spectrophotometry following administration of the final formulation afamelanotide bioresorbable implants in healthy volunteers."},{"outcome_type":"secondary","measure":"Change in plasma concentrations of afamelanotide","time_frame":"60 days","description":"To confirm the pharmacokinetics of afamelanotide by assessing afamelanotide plasma concentration following administration of the final formulation afamelanotide bioresorbable implants in healthy volunteers."},{"outcome_type":"secondary","measure":"Number of Adverse Events","time_frame":"60 days","description":"To confirm the tolerance of afamelanotide by assessing adverse events following administration of the final formulation afamelanotide implants in healthy volunteers."}]}
{"nct_id":"NCT00983840","start_date":"2009-09-30","phase":"N/A","enrollment":151,"brief_title":"Family Eats:Cancer Prevention for Families","official_title":"Family Eats:Cancer Prevention for Families","primary_completion_date":"2012-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-10-31","last_update":"2015-03-20","description":"Poor diets lead to weight problems, and may increase cancer risk. Cancers may develop over a long period of time, with some possibly initiating in childhood. Therefore, promoting healthy diets and preventing excess weight gain during childhood could be cancer protective. Families influence children's dietary behaviors by their actions and controlling the home food environment. The internet provides family access to interventions with the convenience of the home. An eight-session interactive web-based program promoting a healthy home food environment for African-American families with 9-12 year old daughters (Family Eats) was previously developed and tested. This study tests whether the Family Eats web program improves diet and weight outcomes among 320 African-American families with 8-12 year old children. This important study will pioneer a new channel for behavior change intervention with African-American families and holds the promise of reaching large numbers of children and their families, enabling all to adopt healthy eating behaviors and achieve energy balance and reduce cancer risks.","other_id":"124505-01A1","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":8,"maximum_age":10,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  African -American families with 8-10 year old children\r\n\r\n          -  Home computer with dsl line\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Parents or children who report a medically prescribed diet, identified through a\r\n             pre-screening questionnaire, will be excluded because these mothers may have received\r\n             prior dietary counseling and have increased motivation for making dietary changes.\r\n      ","sponsor":"Baylor College of Medicine","sponsor_type":"Other","conditions":"Healthy","interventions":[{"intervention_type":"Other","name":"Other: Family Eats","description":"8-session web-based program on healthy eating for African American families"}],"outcomes":[{"outcome_type":"primary","measure":"Diet (fruit, vegetables, sweetened beverages, fat and calories)","time_frame":"baseline, post and 6 months"},{"outcome_type":"secondary","measure":"BMI","time_frame":"baseline, post and 6 months"}]}
{"nct_id":"NCT01187875","start_date":"2009-09-30","phase":"Early Phase 1","enrollment":20,"brief_title":"Resistant Starch and Satiety","official_title":"Satiety Response of Resistant Starches","primary_completion_date":"2010-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-06-30","last_update":"2012-03-29","description":"Dietary fiber consumption may contribute to weight regulation by improving satiety. In an earlier study the investigators found that a muffin containing resistant starch was more effective than other fibers in altering satiety. The objective of this study is to determine if 2 resistant starches consumed in muffins alter satiety and whether a mixture of resistant starches is more effective than either alone in enhancing satiety.","other_id":"806M37445","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Prevention","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":64,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy men and women\r\n\r\n          -  Age 18-64 years\r\n\r\n          -  Non-smoking\r\n\r\n          -  Not taking medication\r\n\r\n          -  Non dieting (weight stable in prior 3 months)\r\n\r\n          -  BMI 18-27\r\n\r\n          -  English literacy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Do not regularly consume breakfast\r\n\r\n          -  Food allergies to ingredients found in the study products\r\n\r\n          -  BMI <18 or >27\r\n\r\n          -  Diagnosed cardiovascular disease, renal disease, hepatic disease, or diabetes mellitus\r\n\r\n          -  Cancer in previous 5 years\r\n\r\n          -  Any gastrointestinal disease or condition\r\n\r\n          -  Recent bacterial infection (< 3months)\r\n\r\n          -  Recent or concurrent participation in an intervention research study\r\n\r\n          -  History of drug or alcohol abuse in prior 6 months\r\n\r\n          -  Use of lipid lowering, anti-hypertensive, or anti-inflammatory steroid medication\r\n\r\n          -  Eating disorder\r\n\r\n          -  Vegetarians\r\n\r\n          -  People who eat more than approximately 15 grams of fiber per day\r\n\r\n          -  Women who are pregnant or lactating\r\n\r\n          -  Women with irregular menstrual cycles\r\n      ","sponsor":"University of Minnesota","sponsor_type":"Other","conditions":"Healthy Adults","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Placebo- Fiber free control","description":"Dextrin control administered in a muffin treatment."},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Hi-maize resistant starch 9g","description":"9g Hi-maize resistant starch administered in a muffin treatment."},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Novalose 330 resistant starch 9g","description":"9g Novalose 330 resistant starch administered in a muffin treatment."},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: 4.5g Hi-maize resistant starch and 4.5g Novalose 330","description":"4.5g Hi-maize and 4.5g Novalose 330 in a muffin treatment."}],"outcomes":[{"outcome_type":"primary","measure":"Satiety response using visual analogue scales","time_frame":"0 minutes postprandially","description":"Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS)."},{"outcome_type":"primary","measure":"Satiety response using VAS","time_frame":"15 minutes postprandially","description":"Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS)."},{"outcome_type":"primary","measure":"Satiety response using VAS","time_frame":"30 minutes postprandially","description":"Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS)."},{"outcome_type":"primary","measure":"Satiety response using VAS","time_frame":"45 minutes postprandially","description":"Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS)."},{"outcome_type":"primary","measure":"Satiety response using VAS","time_frame":"60 minutes postprandially","description":"Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS)."},{"outcome_type":"primary","measure":"Satiety response using VAS","time_frame":"90 minutes postprandially","description":"Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS)."},{"outcome_type":"primary","measure":"Satiety response using VAS","time_frame":"120 minutes postprandially","description":"Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS)."},{"outcome_type":"primary","measure":"Satiety response using VAS","time_frame":"180 minutes postprandially","description":"Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS)."},{"outcome_type":"primary","measure":"Satiety response using VAS","time_frame":"240 minutes postprandially","description":"Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS)."},{"outcome_type":"secondary","measure":"Ad libitum food intake","time_frame":"240 minutes postprandially and over 24 hours"},{"outcome_type":"secondary","measure":"Breath hydrogen response","time_frame":"0, 240 minutes"},{"outcome_type":"secondary","measure":"Gastrointestinal tolerance using visual analogue scales (VAS)","time_frame":"24 hours","description":"Subjective ratings of bloating, stool consistency, and flatulence on VAS. A stool count was also recorded."}]}
{"nct_id":"NCT01704222","start_date":"2009-09-30","enrollment":2001,"brief_title":"Epidemiology of Human Cytomegalovirus Excretion in the Saliva of Children Attending Nursery in France","official_title":"Epidemiology of Human Cytomegalovirus Excretion in the Saliva of Children Attending Nursery in France.","primary_completion_date":"2012-02-29","study_type":"Observational","rec_status":"Completed","completion_date":"2013-09-30","last_update":"2013-11-01","description":"Direct DNA amplification, viral isolation and specific antibody measurement in saliva from children attending nursery in France Sample collection will be done by the pediatrician the nurse, or one of the authorized investigators of the study.","other_id":"I07040 CrchMV","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":3,"maximum_age":6,"population":"Children older than 3 months and less than 6 years kept in nurseries retained, regardless\r\n        of the duration of custody of the child in the manger concerned.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Children older than 3 months and less than 6 years kept in nurseries retained,\r\n             regardless of the duration of custody of the child in the manger concerned.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Refusal of parents (lack of consent)\r\n\r\n          -  Refusal of the child according to his ability to understand\r\n\r\n          -  Uninsured social security\r\n      ","sponsor":"University Hospital, Limoges","sponsor_type":"Other","conditions":"Healthy Volunteers","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Identification of viral shedding","time_frame":"1 day","description":"Saliva using small sponges, non-invasive for the viral genome, isolating virus strains and measurement of antibody IgG and IgA."},{"outcome_type":"secondary","measure":"Evaluate the distribution of different genotypes of strains of CMV","time_frame":"1 day","description":"distribution by genotype strains found"}]}
{"nct_id":"NCT01044550","start_date":"2009-09-30","phase":"N/A","enrollment":66,"brief_title":"Laparoscopy Versus Clinical Follow up to Detect Diaphragm Injury","official_title":"Laparoscopy (to Detect Occult Diaphragm Injury) Versus Clinical and Radiological Follow up to Detect Diaphragm Injury and Herniation, in Patients With Asymptomatic Left Thoracoabdominal Stab Wounds: A Prospective Randomized Controlled Study","primary_completion_date":"2014-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-10-31","last_update":"2015-01-22","description":"Title: A randomized prospective study comparing non operative management with laparoscopic treatment in patients with a diaphragm injury following left thoracoabdominal stab wounds. Aim of the Study: The aim of this study is to access the clinical outcome of potential occult diaphragm injuries in a group of patients presenting at the Groote Schuur trauma centre with left sided thoracoabdominal stab wounds, if an expectant non operative management course is taken. Objects of the Study: To obtain the above mentioned aim the study will undertake; - to do laparoscopy on a group of randomly selected patients with left thoracoabdominal stab wounds to obtain the incidence of occult diaphragm injury. - to assess the incidence and clinical outcome of delayed diaphragm visceral herniation in the study group.","other_id":"mlhgid004","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Diagnostic","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Hemodynamically stable patients\r\n\r\n          -  Patients with penetrating stab wounds bounded by\r\n\r\n          -  Superiorly the 4th intercostal space\r\n\r\n          -  Lateral the tip of the left scapula\r\n\r\n          -  Inferior by the left costal margin\r\n\r\n          -  Medially by the sternum\r\n\r\n          -  Signed informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Hemodynamically unstable patients\r\n\r\n          -  Previous penetrating injury to the area mentioned under inclusion criteria\r\n\r\n          -  Patients requiring early surgical exploration for injuries other than diaphragm\r\n             injuries\r\n\r\n          -  If a diaphragm injury is detected on imaging\r\n\r\n          -  A positive pregnancy test\r\n      ","sponsor":"University of Cape Town","sponsor_type":"Other","conditions":"Diaphragm Injury","interventions":[{"intervention_type":"Procedure","name":"Procedure: Laparoscopy","description":"Treatment group will undergo a laparoscopy, with repair of the diaphragm if injury found"},{"intervention_type":"Other","name":"Other: Clinical follow up","description":"Control group will undergo no treatment except suturing of wounds and drainage of the hemo-pneumothorax, if present. Then clinical follow up."}],"outcomes":[{"outcome_type":"primary","measure":"To assess the clinical outcome of potential occult diaphragm injuries in patients presenting at the Groote Schuur trauma centre with left sided thoracoabdominal stab wounds, if an expectant non operative management course is taken.","time_frame":"2 years"}]}
{"nct_id":"NCT02315794","start_date":"2009-09-30","phase":"Phase 2","enrollment":24,"brief_title":"Aesthetic Outcomes of Single Tooth Implant Using Metal Ceramic Restorations With Either Zirconia or Titanium Abutments","official_title":"Aesthetic Outcomes of Single Tooth Implant-supported Restorations Using Metal Ceramic Restorations With Either Zirconia or Titanium Abutments: A Randomized Controlled Clinical Study","primary_completion_date":"2010-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-02-28","last_update":"2014-12-12","description":"Different studies have proposed the use of zirconia abutments to improve the aesthetic outcomes in the anterior sextant, however the results have been inconclusive. A tendency towards a better aesthetic result with the use of zirconia instead of titanium abutments was observed, although more technical complications were also recorded.The use of zirconia abutments in the anterior maxillary region showed a tendency towards better matching, although differences were not significant. In addition, with these abutments more technical complications were observed, what increased the cost and time. More studies with larger samples and longer observations periods are needed to recommend the use of zirconia abutments for this clinical situation","other_id":"aostirct","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  mono-edentulism condition in the aesthetic zone\r\n\r\n          -  minimum of 2 mm of keratinized gingiva\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  systemic diseases\r\n      ","sponsor":"University of Firenze and Siena, Napoli, Italy","sponsor_type":"Other","conditions":"Thick Gingival Margin to Tooth Restoration","interventions":[{"intervention_type":"Device","name":"Device: SPIART","description":"implant prothetic restoration using a yttrium oxide stabilized zirconia abutment"},{"intervention_type":"Device","name":"Device: SPIEASY","description":"implant prosthetic restoration using a commercially pure titanium grade 4 abutment"}],"outcomes":[{"outcome_type":"primary","measure":"change from baseline in the anatomic form and surface characteristics of the peri implant mucosa","time_frame":"one month and one year after the placement of the definitive crowns","description":"the following parameters were assessed by means of standardized photographs: contour of the labial surface of the mucosa and its colour; when compared to the adjacent teeth , penalty points were assigned ( 0 = excellent; 1 or 2 = satisfactory; 3 or 4 = moderate; 5 ore more, poor)."},{"outcome_type":"secondary","measure":"change from baseline in crestal bone levels","time_frame":"one month and one year after placing the definitive crown","description":"in standardized intraoral radiographs the the following measurements were carried out : vertical distance from implant shoulder to the most coronal bone in contact with the implant at mesial and distal site; horizontal distance from the implant shoulder to the adjacent teeth at mesial and distal sites; vertical distance ( parallel to the implant long axis) from the contact point to the bone crest at mesial and distal sides"},{"outcome_type":"secondary","measure":"change from baseline in interdental soft tissue position","time_frame":"one month and one year after the placement of the definitive crowns","description":"position of interdental papilla measured by means of Papilla Index ( Jemt, 1997)"},{"outcome_type":"secondary","measure":"change from baseline in thickness of the peri implant mucosa","time_frame":"one month and one year after the placement of the definitive crowns","description":"the thickness was measured by placing a calibrated endodontic file 2mm apical to the mucosal margin"}]}
{"nct_id":"NCT01327417","start_date":"2009-09-30","enrollment":400,"brief_title":"Late-Life Depression","official_title":"Cortical/Subcortical Circuits in Late-Life Depression","primary_completion_date":"2013-04-30","study_type":"Observational","rec_status":"Unknown status","completion_date":"2013-04-30","last_update":"2011-04-01","description":"The purpose of the study is to examine the relationship between brain structure and depression in adults aged 60 or older. This relationship is determined using magnetic resonance imaging technology (MRI), a scanner with a magnet that is used to create images of the brain.","other_id":"2009-0613","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":60,"population":"-  Geriatric Medicine and Psychiatry clinics within the UIC Medical Center. Patients with\r\n             mood and other psychiatric disturbances are frequently referred by physicians from\r\n             both geriatric medicine and family medicine for a consultation and sometimes for\r\n             ongoing psychiatric care.\r\n\r\n          -  Community outreach efforts and recruitment through advertising in newsletters, local\r\n             newspapers","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age: 60 years or greater\r\n\r\n          -  Diagnosis of major depressive disorder using standard diagnostic and statistical\r\n             manual (DSM) criteria\r\n\r\n          -  Score of 15 or greater on the 17-item Hamilton Depression rating scale\r\n\r\n          -  Mini Mental Status Exam score of 24 or greater\r\n\r\n          -  No evidence of clinical dementia or any other clinical brain disorder\r\n\r\n          -  Free of psychotropic/psychoactive medications for at least 2 weeks\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Presence of dementia or any other clinical brain disorder (Parkinson's, Alzheimer's)\r\n\r\n          -  History of progressive cognitive decline and/or Mini Mental Status Exam score of less\r\n             than 24\r\n\r\n          -  Lifetime diagnosis of substance abuse\r\n\r\n          -  Unstable medical illness (grade 4 on the Cumulative Illness Rating Scale)\r\n\r\n          -  Presence of any metallic implant that would preclude an MRI scan (pacemaker, etc.)\r\n\r\n          -  Concurrent Axis 1 disorder (schizophrenia, bipolar)\r\n\r\n          -  Psychotropic medication implicated in depression i.e. Reserpine, Alpha methyl dopa,\r\n             Beta blockers, multiple long acting benzodiazepines (valium, flurazepam,\r\n             chlordiazepoxide), neuroleptics;\r\n\r\n          -  Seizure disorder\r\n\r\n          -  Stroke/Transient Ischemic Attack\r\n\r\n          -  Central nervous system disorder (Parkinson's disease, multiple sclerosis)\r\n\r\n          -  Trauma to head/Loss of Consciousness\r\n\r\n          -  Claustrophobia\r\n\r\n          -  Eating disorder (anorexia, bulimia)\r\n\r\n          -  Weight of over 350 pounds\r\n\r\n          -  Learning disorder (dyslexia, ADHD)\r\n\r\n          -  Psychosis, panic or anxiety disorder outside the context of depression\r\n\r\n          -  Mood stabilizing agents such as lithium and Divalproex sodium and antidepressants - as\r\n             they have been shown to impact on brain levels of NAA, Ch and Ml\r\n      ","sponsor":"University of Illinois at Chicago","sponsor_type":"Other","conditions":"Depression","interventions":{},"outcomes":{}}
{"nct_id":"NCT00915564","start_date":"2009-09-30","phase":"Phase 1","enrollment":13,"brief_title":"A Study to Investigate the Potential Pharmacokinetic Interaction Between TMC435 and Methadone","official_title":"A Phase I, Open-Label, Single-Sequence Drug-Drug Interaction Trial in Subjects On Stable Methadone Maintenance Therapy, to Investigate the Potential Pharmacokinetic Interaction Between TMC435 and Methadone, at Steady-State","primary_completion_date":"2010-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-01-31","last_update":"2013-10-16","description":"The purpose of this study is to evaluate the effect of steady-state (constant concentration of medication in the blood) TMC435 (150 mg, once a day) on the steady state pharmacokinetics (what the body does to the medication) of R- and S-methadone.","other_id":"CR015934","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Receiving once daily oral methadone maintenance therapy at a stable individualized\r\n             dose of 30 to 130 mg once daily for at least 30 days prior to screening\r\n\r\n          -  Agreeing not to change the current methadone dose from screening until Day7 included\r\n             and to have a daily observed and documented methadone intake from Day-14 until Day8\r\n             and to have a daily observed and documented TMC435 intake from Day1 until Day 7\r\n\r\n          -  Having obtained approval from his/her addiction physician for participation in the\r\n             trial and addiction physician agrees to provide medical care for the volunteer after\r\n             discharge from the testing facility\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  No female of childbearing potential, except if using effective birth control methods\r\n             during the trial and for at least 30 days after the end of the treatment period\r\n\r\n          -  No positive testing for drugs of abuse\r\n\r\n          -  No positive testing for Hepatitis A, B and C and for HIV1 and 2\r\n\r\n          -  Impaired liver disease or other clinically relevant diseases\r\n      ","sponsor":"Tibotec Pharmaceuticals, Ireland","sponsor_type":"Industry","conditions":"Hepatitis C","interventions":[{"intervention_type":"Drug","name":"Drug: TMC435","description":"Participants will receive 150 mg dose of TMC435 orally (by mouth) once daily for 7 days of treatment (from Day 1 to Day 7)."},{"intervention_type":"Other","name":"Other: Methadone","description":"Participants will receive supervised individualized methadone dose (dose of methadone will be adjusted for each participant between a range of 30 and 150 mg daily [extremes included]) from Day -14 untill Day 8. Participants will continue to receive individualized methadone during follow up of 30 to 32 days."}],"outcomes":[{"outcome_type":"primary","measure":"Predose plasma concentration of S-methadone","time_frame":"Day -4 to Day 6"},{"outcome_type":"primary","measure":"Maximum plasma concentration of S-methadone","time_frame":"On Day -1 and Day 7 at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours postdose"},{"outcome_type":"primary","measure":"Minimum plasma concentration between 0 hour and dosing interval of S-methadone","time_frame":"On Day -1 and Day 7 at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours postdose"},{"outcome_type":"primary","measure":"Average steady-state plasma concentration of S-methadone","time_frame":"On Day -1 and Day 7 at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours postdose"},{"outcome_type":"primary","measure":"Time to reach the maximum plasma concentration of S-methadone","time_frame":"On Day -1 and Day 7 at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours postdose"},{"outcome_type":"primary","measure":"Area under the curve from time of administration up to 24 hours post dosing of S-methadone","time_frame":"On Day -1 and Day 7 at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours postdose"},{"outcome_type":"primary","measure":"Fluctuation index of S-methadone, ie, percentage fluctuation (variation between maximum and minimum concentration at steady-state)","time_frame":"On Day -1 and Day 7 at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours postdose"},{"outcome_type":"primary","measure":"Predose plasma concentration of R-methadone","time_frame":"Day -4 to Day 7"},{"outcome_type":"primary","measure":"Maximum plasma concentration of R-methadone","time_frame":"On Day -1 and Day 7 at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours postdose"},{"outcome_type":"primary","measure":"Minimum plasma concentration between 0 hour and dosing interval of R- and S-methadone","time_frame":"On Day -1 and Day 7 at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours postdose"},{"outcome_type":"primary","measure":"Average steady-state plasma concentration of R-methadone","time_frame":"On Day -1 and Day 7 at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours postdose"},{"outcome_type":"primary","measure":"Time to reach the maximum plasma concentration of R-methadone","time_frame":"On Day -1 and Day 7 at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours postdose"},{"outcome_type":"primary","measure":"Area under the curve from time of administration up to 24 hours post dosing of R-methadone","time_frame":"On Day -1 and Day 7 at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours postdose"},{"outcome_type":"primary","measure":"Fluctuation index of R-methadone, ie, percentage fluctuation (variation between maximum and minimum concentration at steady-state)","time_frame":"On Day -1 and Day 7 at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours postdose"},{"outcome_type":"primary","measure":"Predose plasma concentration of TMC435","time_frame":"Day 4 to Day 6"},{"outcome_type":"primary","measure":"Maximum plasma concentration of TMC435","time_frame":"On Day 7 at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours postdose and on Day 8 at 24 hour postdose"},{"outcome_type":"primary","measure":"Minimum plasma concentration between 0 hour and dosing interval of TMC435","time_frame":"On Day 7 at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours postdose and on Day 8 at 24 hour postdose"},{"outcome_type":"primary","measure":"Average steady-state plasma concentration of TMC435","time_frame":"On Day 7 at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours postdose and on Day 8 at 24 hour postdose"},{"outcome_type":"primary","measure":"Time to reach the maximum plasma concentration of TMC435","time_frame":"On Day 7 at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours postdose and on Day 8 at 24 hour postdose"},{"outcome_type":"primary","measure":"Area under the curve from time of administration up to 24 hours post dosing of TMC435","time_frame":"On Day 7 at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours postdose and on Day 8 at 24 hour postdose"},{"outcome_type":"primary","measure":"Fluctuation index of TMC435, ie, percentage fluctuation (variation between maximum and minimum concentration at steady-state)","time_frame":"On Day 7 at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 hours postdose and on Day 8 at 24 hour postdose"},{"outcome_type":"secondary","measure":"Short Opiate Withdrawal Scale Scores","time_frame":"On Day-1 and Day 7 at 2 hour and 4 hour predose; on Day-7, Day-2, and Day 1 to Day 6 at predose","description":"Short Opiate Withdrawal Scale is used for the assessment of opioid withdrawal. It consists of 10 items and items are designed to measure symptoms, on a scale from 0 to 3 (0= None, 1= Mild, 2= Moderate, 3= Severe). The total score ranges from 0 (best) to 30 (worst). Higher scores indicate worsening."},{"outcome_type":"secondary","measure":"Desires for Drugs Questionnaire","time_frame":"On Day-1 and Day 7 at 2 hour and 4 hour predose; on Day-7, Day-2, and Day 1 to Day 6 at predose"},{"outcome_type":"secondary","measure":"Resting pupil diameter","time_frame":"On Day-1 and Day 7 at 2 hour and 4 hour predose; on Day-7, Day-2, and Day 1 to Day 6 at predose","description":"Pupillometry will be performed and resting pupil diameter will be assessed with a validated pupillograph."},{"outcome_type":"secondary","measure":"Number of participants with adverse events as a measure of safety and tolerability","time_frame":"Up to 30 to 32 days after the last medication dose"}]}
{"nct_id":"NCT01580787","start_date":"2009-08-31","phase":"N/A","enrollment":32,"brief_title":"Functional Improvement in Patients With Parkinson's Disease After Training in Real or Virtual Environment","official_title":"Functional Improvement in Patients With Parkinson's Disease After Training in Real or Virtual Environment","primary_completion_date":"2011-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-04-30","last_update":"2012-04-19","description":"The objective of this work was to compare the effects of two balance training programs, one Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system, on the balance, functionality and cognition of patients with Parkinsons disease. It was a prospective, single blinded, randomized clinical trial performed at Brazil Parkinson Association and Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of So Paulo University. 32 patients with Parkinsons disease on stages 1 and 2,5 of Hoehn e Yahr participated of this work. Patients were randomized in control and experimental group, 16 each one. The study was finished at december 2011.","other_id":"saocamilo-sp","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":65,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with Parkinsons disease\r\n\r\n          -  both gender\r\n\r\n          -  on stages 1 and 2,5 of Hoehn e Yahr\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  depression\r\n\r\n          -  cognitive impairment\r\n\r\n          -  deficits of visual acuity\r\n\r\n          -  Score on Berg Balance Scale under 46\r\n      ","sponsor":"Sao Camilo University Center","sponsor_type":"Other","conditions":"Parkinsons Disease","interventions":[{"intervention_type":"Device","name":"Device: Balance Training with Nintendo Wii Fit","description":"The participants of the study trained 10 balance games during 14 sessions."},{"intervention_type":"Other","name":"Other: Physical Therapy","description":"Patients of the control group was trained with balance exercises."}],"outcomes":[{"outcome_type":"primary","measure":"UNIFIED PARKINSON'S DISEASE RATING SCALE","time_frame":"08/2011 (up to 2 years)","description":"The scale assesses the functional status of patients with parksinon´s disease, including the independency of daily activities, mood, secondary effects of medications and motor complications."},{"outcome_type":"secondary","measure":"Berg Balance Scale","time_frame":"08/2011 (up to 2 years)","description":"Berg Balance Scale assesses the functional balance of patients with Parkinson´s disease. It is a clinic assessment of patient that evaluates the performance of patient to stand up and sit down, turn on and step, among others situations."}]}
{"nct_id":"NCT00957229","start_date":"2009-08-31","phase":"Phase 2","enrollment":41,"brief_title":"To Determine The Efficacy and Safety of GDC-0449 in Patients With Basal Cell Nevus Syndrome (BCNS)","official_title":"A Randomized, Phase II Multicenter Trial Evaluating the Efficacy and Safety of a Systemic Hedgehog Pathway Antagonist (GDC-0449) in Patients With Basal Cell Nevus Syndrome (BCNS)","primary_completion_date":"2014-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-01-31","last_update":"2021-01-11","description":"The purpose of this study is to reduce the number of new surgically eligible BCCs by 50% appearing during month 3-18 of medication ingestion.","other_id":"2009-026","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":35,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        The subject:\r\n\r\n          -  has had diagnosed at least 10 SEB (of diameter 3 mm diameter or greater on the nose or\r\n             periorbital skin, 5 mm or greater elsewhere on the face, or 9 mm or greater on\r\n             non-facial areas excluding the skin below the knees) during the two years before study\r\n             entry, as documented histologically in physicians' records and/or diagnosed clinically\r\n             by a Study Investigator at baseline.\r\n\r\n          -  meet diagnostic criteria for basal cell nevus syndrome\r\n\r\n          -  is willing to abstain from application of non-study topical medications to the skin\r\n             for the duration of the study, including prescription and over the counter\r\n             preparations. Subjects will be encouraged to use sunscreen (SPF 15) at least once\r\n             daily on all exposed skin sites.\r\n\r\n          -  is willing to forego treatment of BCCs unless the BCCs are documented by Study\r\n             Investigators, preferably on two separate visits, except when the PSCP believes that\r\n             delay in treatment potentially might compromise the health of the subject.\r\n\r\n          -  has normal laboratory tests as defined by the following: Normal hematopoietic\r\n             capacity, Normal hepatic function: AST and ALT greater than or equal to 2x the upper\r\n             limit of normal (ULN) Total bilirubin within normal range 0.20 mg/dl to 1.50 mg/dl or\r\n             within 3x ULN for patients with Gilbert's disease Normal renal function: normal serum\r\n             creatinine or measured creatinine clearance less than 50 mL/minute. Fasting\r\n             cholesterol greater than or equal to 220 untreated\r\n\r\n          -  be willing to not donate blood or semen for three months following discontinuation of\r\n             Study medications.\r\n\r\n          -  is willing to avoid pregnancy in his partner as defined by the following: Male subject\r\n             is willing to use a latex condom during the study and for 3 months after the last dose\r\n             during sexual contact with a female of childbearing potential, even if he has had a\r\n             successful vasectomy. His partner must also use a form of birth control\r\n\r\n        Exclusion Criteria:\r\n\r\n        The subject:\r\n\r\n          -  has used topical or systemic therapies that might interfere with the evaluation of the\r\n             study medication during the study. Specifically these include the use of: (i)\r\n             glucocorticoids to more than 5% of the skin (ii) retinoids systemically or topically\r\n             to more than 5% of the skin during the six months prior to study entry; (iii)\r\n             alpha-hydroxy acids to more than 5% of the skin during the six months prior to study\r\n             entry (iv) 5-fluorouracil or imiquimod systemically or topically to the skin above the\r\n             knees during the six months prior to study entry. (v) treatment with systemic\r\n             chemotherapy within one year prior to starting study medication.\r\n\r\n          -  has a history of hypersensitivity to any of the ingredients in the study medication\r\n             formulations.\r\n\r\n          -  is unable to return for follow-up visits and tests.\r\n\r\n          -  has uncontrolled systemic disease, including known HIV positive patients.\r\n\r\n          -  has history of congestive heart failure.\r\n\r\n          -  has uncontrolled hypocalcemia, hypomagnesemia, or hypokalemia\r\n\r\n          -  has clinically important history of liver disease, including viral or hepatitis,\r\n             current alcohol abuse, or cirrhosis.\r\n\r\n          -  has any condition or situation which in the Investigator's opinion may put the subject\r\n             at significant risk, could confound the study results, or could interfere\r\n             significantly with the subject's participation in the study.\r\n\r\n          -  has a history of invasive cancer within the past five years excluding non-melanoma\r\n             skin cancer, Stage I cervical cancer, ductal carcinoma in situ of the breast, or CLL\r\n             Stage 0.\r\n\r\n          -  has current, recent (within 4 weeks of Day 1), or planned participation in an\r\n             experimental drug study while enrolled in this study.\r\n\r\n          -  is a female who is pregnant, plans to ever to become pregnant, capable of becoming\r\n             pregnant or is breast feeding.\r\n\r\n          -  is a male who is unwilling or unable to comply with pregnancy prevention measures.\r\n      ","sponsor":"UCSF Benioff Children's Hospital Oakland","sponsor_type":"Other","conditions":"Basal Cell Nevus Syndrome|Gorlin Syndrome","interventions":[{"intervention_type":"Drug","name":"Drug: GDC-0449","description":"capsule, 150 mg, one pill daily, 18 months"}],"outcomes":[{"outcome_type":"primary","measure":"Number of New Surgically Eligible Basal-cell Carcinomas","time_frame":"3 months of receiving study drug","description":"Number of new surgically eligible basal-cell carcinomas per patient per year"},{"outcome_type":"secondary","measure":"Change in Size of the Existing Carcinomas, Expressed as the Sum of Cumulative Diameters in Millimeters Over an 18 Month Period","time_frame":"Baseline and 18 months"},{"outcome_type":"secondary","measure":"Number of New Surgically Eligible Basal-cell Carcinomas After Stopping Vismodegib Treatment","time_frame":"These five patients were given placebo for a mean of 7.4 months (SD 2.3). After receiving vismodegib for a mean of 13.8 months (SD 6.8) and then discontinuing vismodegib for a mean of 11.8 months (SD 7.9) the new basal-cell carcinoma rate is reported.","description":"The number of new surgically eligible basal-cell carcinomas per patient per month is reported."}]}
{"nct_id":"NCT01292642","start_date":"2009-08-31","phase":"Phase 2","enrollment":12,"brief_title":"Cognitive Behavioral Therapy and the Nicotine Transdermal Patch for Cannabis Dependence and Nicotine Dependence","official_title":"Cognitive Behavioral Therapy and the Nicotine Transdermal Patch for Cannabis Dependence and Nicotine Dependence","primary_completion_date":"2011-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-06-30","last_update":"2013-08-14","description":"The investigators are conducting a Stage 1 pilot feasibility study at McLean Hospital to develop and refine a Cognitive Behavioral Therapy (CBT) intervention. The investigators aim to develop a feasible 10-week integrated CBT intervention for the treatment of concurrent marijuana dependence and nicotine dependence. The investigators hypothesize that the CBT intervention, in conjunction with Nicotine Replacement Therapy (NRT) in the form of a transdermal nicotine patch, will reduce the use of marijuana and nicotine.","other_id":"2008-P-000927","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age range 18-65 years\r\n\r\n          -  current DSM-IV cannabis dependence\r\n\r\n          -  current DSM-IV nicotine dependence\r\n\r\n          -  express a desire to quit cannabis and nicotine use within the next 30 days\r\n\r\n          -  daily use of  10 tobacco cigarettes\r\n\r\n          -  for women of childbearing age, a negative pregnancy test at screening with agreement\r\n             to use adequate contraception to prevent pregnancy and additional pregnancy tests at\r\n             weeks 4 and 8\r\n\r\n          -  Expired breath carbon monoxide (CO) determination is greater than or equal to 7 ppm\r\n             over ambient values\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Current diagnosis of other drug or alcohol dependence (other than cannabis or\r\n             nicotine)\r\n\r\n          -  recent (within 3 months) significant cardiac disease\r\n\r\n          -  current serious psychiatric illness or history of psychosis, schizophrenia, bipolar\r\n             type I disorder or significant current suicidal or homicidal thoughts\r\n\r\n          -  current use of bupropion\r\n\r\n          -  current NRT or other smoking cessation treatment\r\n\r\n          -  current CBT or other behavioral treatments for cessation of marijuana or tobacco\r\n             smoking\r\n\r\n          -  current smokeless tobacco use\r\n\r\n          -  inability to read or write in English\r\n      ","sponsor":"Mclean Hospital","sponsor_type":"Other","conditions":"Cannabis Dependence|Nicotine Dependence","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Cognitive Behavioral Therapy","description":"individual CBT once weekly, 50 minutes, for 10 weeks"},{"intervention_type":"Drug","name":"Drug: Nicotine Replacement Therapy","description":"21 mg patch for 6 weeks, 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks\r\n14 m g patch for 8 weeks, then 7 mg patch for 2 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Cigarette Use","time_frame":"Baseline and 10 weeks","description":"cigarettes per day"},{"outcome_type":"primary","measure":"Cannabis Use","time_frame":"Baseline and 10 weeks","description":"cannabis inhalations per day"},{"outcome_type":"secondary","measure":"Client Satisfaction Questionnaire (CSQ-8) at 10 Weeks","time_frame":"10 weeks","description":"The Client Satisfaction Questionnaire (CSQ-8) is a self-report instrument used to assess satisfaction with health services and it was used to assess participant satisfaction with the treatment during this 10 week study. Scores range from 8 - 32 with higher values indicating higher satisfaction."}]}
{"nct_id":"NCT00949884","start_date":"2009-08-31","phase":"Phase 4","enrollment":941,"brief_title":"Olmesartan Comparison to Losartan in Hypertensive Subjects","official_title":"A Randomized, Double-blind, Active-comparator, 8-week Forced-titration Study of the Efficacy and Safety of Olmesartan Medoxomil Versus Losartan Potassium in Hypertensive Subjects","primary_completion_date":"2010-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-01-31","last_update":"2011-03-09","description":"This study will evaluate the efficacy and safety of the FDA approved blood pressure medication olmesartan medoxomil compared to the FDA approved medication losartan potassium.","other_id":"CS0866-A-U452","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Males or females aged > 18 years who are not institutionalized and have signed\r\n             informed consent.\r\n\r\n          -  Mean cuff seated diastolic blood pressure (BP) must be > 95 mmHg and < 115 mmHg and a\r\n             mean cuff seated systolic BP must be < 180 mmHg when measured at two consecutive\r\n             qualification study visits during the placebo run-in phase.\r\n\r\n          -  The difference in mean cuff seated diastolic BP must be < 7 mmHg between two\r\n             consecutive qualification study visits during the placebo run-in phase.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subjects with type 2 diabetes mellitus with an HbA1c  9.5% at Screening.\r\n\r\n          -  Subjects with serious disorders which may limit the ability to evaluate the efficacy\r\n             or safety of olmesartan medoxomil and losartan potassium, including cardiovascular,\r\n             renal (including the absence of one kidney), pulmonary, hepatic, gastrointestinal\r\n             (including clinically significant malabsorption), endocrine/metabolic (with the\r\n             exception of non-insulin, dependent type 2 diabetes mellitus with HbA1c < 9.5% at\r\n             Screening), hematologic/oncologic (including an active malignancy other than basal\r\n             cell carcinoma), neurologic and psychiatric diseases.\r\n\r\n          -  Subjects with a history of myocardial infarction, angina, coronary angioplasty, bypass\r\n             surgery or heart failure within the last 12 months.\r\n\r\n          -  Subjects with any history of New York Heart Association Class III or IV congestive\r\n             heart failure (CHF). A history of New York Heart Association Class I or II CHF may be\r\n             exclusionary at the discretion of the Investigator.\r\n\r\n          -  Subjects with a history of cerebrovascular accident or transient ischemic attack\r\n             within the last 1 year.\r\n\r\n          -  Subjects with clinically significant cardiac conduction defects, including second or\r\n             third degree atrioventricular (AV) block, left bundle branch block, sick sinus\r\n             syndrome, atrial fibrillation, atrial flutter, an accessory bypass tract, or any\r\n             arrhythmia requiring medication.\r\n      ","sponsor":"Daiichi Sankyo, Inc.","sponsor_type":"Industry","conditions":"Hypertension","interventions":[{"intervention_type":"Drug","name":"Drug: olmesartan medoxomil","description":"Oral tablets, once daily, at either 20mg or 40mg daily."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"placebo oral tablets once daily for two weeks"},{"intervention_type":"Drug","name":"Drug: losartan potassium","description":"losartan potassium oral tablet at either 50mg or 100 mg daily dose."}],"outcomes":[{"outcome_type":"primary","measure":"Change From Baseline to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)","time_frame":"Day 0, Week 8","description":"The change from baseline in trough SDBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit."},{"outcome_type":"secondary","measure":"Change From Baseline to Week 4 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)","time_frame":"Day 0, Week 4","description":"The change from baseline in trough SSBP at Week 4 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit."},{"outcome_type":"secondary","measure":"Change From Baseline to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)","time_frame":"Day 0, Week 8","description":"The change from baseline in trough SSBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit."},{"outcome_type":"secondary","measure":"Change From Baseline to Week 4 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)","time_frame":"Day 0, Week 4","description":"The change from baseline in trough SDBP at Week 4 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit."},{"outcome_type":"other","measure":"Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)","time_frame":"Week 4, Week 8","description":"The change from Week 4 in trough SDBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit."},{"outcome_type":"other","measure":"Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)","time_frame":"Week 4, Week 8","description":"The change from Week 4 in trough SSBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit."},{"outcome_type":"other","measure":"Percentage of Participants Achieving Blood Pressure Goals at Week 4","time_frame":"Week 4","description":"Percentage of participants who achieved the following goals:\r\nSystolic blood pressure: <140 mmHg, <135 mmHg, <130 mmHg, <120 mmHg Diastolic blood pressure: <90 mmHg, <85 mmHg, <80 mmHg Blood pressure: <140/90 mmHg, <135/80 mmHg, <130/80 mmHg"},{"outcome_type":"other","measure":"Percentage of Participants Achieving Blood Pressure Goals at Week 8","time_frame":"Week 8","description":"Percentage of participants who achieved the following goals:\r\nSystolic blood pressure: <140 mmHg, <135 mmHg, <130 mmHg, <120 mmHg Diastolic blood pressure: <90 mmHg, <85 mmHg, <80 mmHg Blood pressure: <140/90 mmHg, <135/80 mmHg, <130/80 mmHg, <120/80 mmHg"},{"outcome_type":"other","measure":"Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 4","time_frame":"Baseline, Week 4","description":"In week 4, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours."},{"outcome_type":"other","measure":"Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 8","time_frame":"Baseline, Week 8","description":"In week 8, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours."},{"outcome_type":"other","measure":"Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 4","time_frame":"Baseline, Week 4","description":"In week 4, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Daytime (8am to 4pm) and nighttime (10pm to 6am) systolic and diastolic blood pressure readings are summarized."},{"outcome_type":"other","measure":"Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 8","time_frame":"Baseline, Week 8","description":"In week 8, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Daytime (8am to 4pm) and nighttime (10pm to 6am) systolic and diastolic blood pressure readings are summarized."},{"outcome_type":"other","measure":"Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 4","time_frame":"Baseline, Week 4","description":"In week 4, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Systolic and diastolic blood pressure readings taken in the final 2, 4, and 6 hours of the 24-hour ABPM cycle are summarized."},{"outcome_type":"other","measure":"Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 8","time_frame":"Baseline, Week 8","description":"In week 8, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Systolic and diastolic blood pressure readings taken in the final 2, 4, and 6 hours of the 24-hour ABPM cycle are summarized."},{"outcome_type":"other","measure":"Change From Baseline to Week 2 in Trough, Cuff, Seated Blood Pressure","time_frame":"Baseline, Week 2","description":"The change from baseline in trough systolic and diastolic blood pressure at Week 2 as measured by the Omron monitor. Morning doses of study medication were taken after the exam, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit."}]}
{"nct_id":"NCT00802282","start_date":"2009-08-31","phase":"Phase 1","enrollment":75,"brief_title":"Psilocybin and Spiritual Practice","official_title":"Effects of Psilocybin and Spiritual Practice on Persisting Changes in Attitudes and Behavior","primary_completion_date":"2014-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-05-31","last_update":"2016-02-24","description":"This study will investigate the effects of psilocybin dose and the frequency and intensity of support activities for spiritual practice (e.g., meditation) on a battery of attitudinal and behavioral outcome measures in 75 healthy volunteers who are interested in pursuing a program of spiritual practices with the intention applying spiritual insights and knowledge to everyday life. After screening and study enrollment, each volunteer will be assigned to one of five groups that vary in dose, frequency and intensity of support for spiritual practice, and number of psilocybin sessions (either 2 or 3 sessions). The psilocybin dose manipulation will be double-blind. Volunteers will be told that in each of sessions 1, 2, and 3, he/she could receive a very low, low, moderate, moderately high, or high dose of psilocybin. They will be told that each participant will receive 2 or more dose levels of psilocybin over the 2 or 3 sessions, and all participants will have one or more sessions in which he or she receives a moderately high or high dose of psilocybin. The duration of each volunteer's participation will be approximately 6 to 8 months. Each volunteer will receive several hours of preparation with the study guides in the month prior to the first psilocybin session; the first two sessions will be separated by one month. Various measures will be assessed before, during and immediately after sessions. A battery of longitudinal measures will be evaluated immediately after study enrollment, 3 weeks after the second psilocybin session, and 4 months after the second psilocybin session (6 months after study enrollment). For purposes of controlling expectancies through the 6 month follow-up evaluation, volunteers and guides will not know which volunteers or how many volunteers will be scheduled for a third session.","other_id":"NA_00020767","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":21,"maximum_age":70,"population":"","criteria":"\n        Eligibility criteria for volunteers who will receive psilocybin\r\n\r\n        Inclusion Criteria:\r\n\r\n          -  21 to 70 years old\r\n\r\n          -  Have given written informed consent\r\n\r\n          -  Have a high school level of education\r\n\r\n          -  Be healthy and psychologically stable as determined by screening for medical and\r\n             psychiatric problems via a personal interview, a medical questionnaire, a physical\r\n             examination, an electrocardiogram (ECG), and routine medical blood and urinalysis\r\n             laboratory tests.\r\n\r\n          -  Have an active interest in exploring and developing their spiritual lives\r\n\r\n          -  Cigarette smokers must agree to abstain from smoking on psilocybin session days from 1\r\n             hour before psilocybin administration until at least 6 hours after psilocybin\r\n             administration.\r\n\r\n          -  Agree to consume approximately the same amount of caffeine-containing beverage (e.g.,\r\n             coffee, tea) that he/she consumes on a usual morning, before arriving at the research\r\n             unit on the mornings of drug session days. If the volunteer does not routinely consume\r\n             caffeinated beverages, he or she must agree not to do so on session days.\r\n\r\n          -  Agree to refrain from using any psychoactive drugs, including alcoholic beverages,\r\n             within 24 hours of each psilocybin administration. Exceptions include caffeine and\r\n             nicotine.\r\n\r\n          -  Agree not to take any PRN medications on the mornings of psilocybin sessions\r\n\r\n          -  Agree that for one week before each psilocybin session, he/she will refrain from\r\n             taking any nonprescription medication, nutritional supplement, or herbal supplement\r\n             except when approved by the study investigators. Exceptions will be evaluated by the\r\n             study investigators and will include acetaminophen, non-steroidal anti-inflammatory\r\n             drugs, and common doses of vitamins and minerals.\r\n\r\n        Exclusion Criteria:\r\n\r\n        General medical exclusion criteria:\r\n\r\n          -  Women who are pregnant (as indicated by a positive urine pregnancy test assessed at\r\n             intake and before each drug session) or nursing; women who are of child-bearing\r\n             potential and sexually active who are not practicing an effective means of birth\r\n             control\r\n\r\n          -  Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled\r\n             hypertension, a clinically significant ECG abnormality (e.g., atrial fibrillation), or\r\n             TIA in the past year\r\n\r\n          -  Epilepsy with history of seizures\r\n\r\n          -  Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of\r\n             hypoglycemia\r\n\r\n          -  Currently taking psychoactive prescription medication on a regular (e.g., daily) basis\r\n\r\n          -  Currently taking on a regular (e.g., daily) basis any medications having a primary\r\n             centrally-acting pharmacological effect on serotonin neurons or medications that are\r\n             MAO inhibitors. For individuals who have intermittent or PRN use of such medications,\r\n             psilocybin sessions will not be conducted until at least 5 half-lives of the agent\r\n             have elapsed after the last dose.\r\n\r\n          -  More than 20% outside the upper or lower range of ideal body weight\r\n\r\n        Psychiatric Exclusion Criteria:\r\n\r\n          -  Current or past history of meeting DSM-IV criteria for Schizophrenia, Psychotic\r\n             Disorder (unless substance-induced or due to a medical condition), or Bipolar I or II\r\n             Disorder.\r\n\r\n          -  Current or past history within the last 5 years of meeting DSM-IV criteria for alcohol\r\n             or drug dependence (excluding caffeine and nicotine) or severe major depression.\r\n\r\n          -  Have a first or second degree relative with Schizophrenia, Psychotic Disorder (unless\r\n             substance induced or due to a medical condition), or Bipolar I or II Disorder.\r\n\r\n          -  Currently meets DSM-IV criteria for Anorexia Nervosa, Bulimia Nervosa, or other\r\n             psychiatric conditions judged to be incompatible with establishment of rapport or safe\r\n             exposure to psilocybin\r\n      ","sponsor":"Johns Hopkins University","sponsor_type":"Other","conditions":"Healthy","interventions":[{"intervention_type":"Drug","name":"Drug: psilocybin","description":"dose manipulation as described in the protocol and to which volunteers are blinded"},{"intervention_type":"Behavioral","name":"Behavioral: Intensity of support for spiritual practice","description":"Volunteers will be assigned to standard or high support, as described in the protocol"},{"intervention_type":"Behavioral","name":"Behavioral: Number of sessions","description":"Volunteers will be assigned to either 2 or 3 sessions, as described in the protocol"}],"outcomes":[{"outcome_type":"primary","measure":"Hood Mysticism Scale","time_frame":"At end of sessions"},{"outcome_type":"primary","measure":"States of Consciousness Questionnaire","time_frame":"At end of sessions"},{"outcome_type":"primary","measure":"Persisting Effects Questionnaire","time_frame":"3 weeks after each session"},{"outcome_type":"secondary","measure":"Daily spiritual experiences scale","time_frame":"Baseline, 3 weeks after second session, 6 months, and 3 weeks after the third session"},{"outcome_type":"secondary","measure":"A battery assessing various measures of gratitude, forgiveness, religious coping, death attitude, life purpose, life satisfaction, and psychological functioning","time_frame":"Baseline, 3 weeks after second session, 6 months, and 3 weeks after the third session"},{"outcome_type":"secondary","measure":"Blood markers of stress and immune function","time_frame":"Baseline, 3 weeks after second session, 6 months, and 3 weeks after the third session"},{"outcome_type":"secondary","measure":"Brief symptom inventory","time_frame":"Baseline, one week after each session, and at 6 months"},{"outcome_type":"secondary","measure":"Visual effects questionnaire","time_frame":"Baseline, 6 months, and 3 weeks after the third session"}]}
{"nct_id":"NCT00976898","start_date":"2009-08-31","phase":"N/A","enrollment":83,"brief_title":"Proton Beam Irradiation for the Treatment of Unresectable Hepatocellular Cancer and Cholangiocarcinoma","official_title":"Phase II Study of Proton Beam Irradiation for the Treatment of Unresectable Hepatocellular Cancer and Cholangiocarcinoma","primary_completion_date":"2017-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-07-31","last_update":"2018-08-15","description":"In this study the investigators will be studying the effects of proton beam radiation therapy. This is a very accurate kind of treatment that has been shown to affect less normal tissue than a photon radiation beam. The accuracy allows the investigators to more safely increase the amount of radiation delivered to eliminate cancer. This accuracy will potentially reduce side effects that participants would normally experience using photon radiation therapy. The purpose of this study is to determine if radiation using proton beam therapy will kill the cancer cells in the participants liver.","other_id":"09-131","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Biopsy proven unresectable or locally recurrent hepatocellular cancer or intrahepatic\r\n             cholangiocarcinoma. Patients with a single lesion must be 12cm or less in greatest\r\n             dimension. For patients with two lesions, no lesion may be greater than 10cm in\r\n             greatest dimension. For patients with three lesions, no lesion may be greater than 6cm\r\n             in greatest dimension. Patients may have single or multinodular tumors (up to 3).\r\n             There must be no evidence of extrahepatic tumor. Portal vein involvement or thrombosis\r\n             is allowed.\r\n\r\n          -  Participants must have measurable disease, defined as at least one lesion that can be\r\n             accurately measured in at least one dimension (longest diameter to be recorded) as\r\n             20mm or greater with conventional techniques or as 10mm or greater with spiral CT\r\n             scan.\r\n\r\n          -  Patients may have had prior chemotherapy, targeted biological therapy, surgery,\r\n             transarterial chemoembolization (TACE), radiofrequency ablation, or cryosurgery for\r\n             their disease as long as it is greater than 4 weeks from first protocol radiation\r\n             treatment (6 weeks for nitrosoureas or mitomycin C). Patients may not have had prior\r\n             radiation to the affected area.\r\n\r\n          -  18 years of age or older\r\n\r\n          -  Expected survival must be greater than three months\r\n\r\n          -  ECOG Performance Status of 0, 1 or 2\r\n\r\n          -  Normal organ and marrow function as outlined in the protocol\r\n\r\n          -  If patient has underlying cirrhosis, only Child-Pugh classification Group A or Group B\r\n             patients should be included in this study.\r\n\r\n          -  Patients must be either surgically sterile or post-menopausal. Male and female\r\n             patients of child-bearing potential must agree to use adequate contraception prior to\r\n             study entry and for the duration of the study participation.\r\n\r\n          -  Individuals with a history of other malignancies are eligible if they have been\r\n             disease-free for at least 5 years and are deemed by the investigator to be at low risk\r\n             for recurrence of that malignancy. Individuals with the following cancers are eligible\r\n             if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal\r\n             cell or squamous cell carcinoma of the skin\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Women who are pregnant or lactating\r\n\r\n          -  Patients with evidence of non-hepatic metastatic disease\r\n\r\n          -  Local conditions or systemic illnesses which would reduce the local tolerance to\r\n             radiation treatment, such as serious local injuries, active collagen vascular disease,\r\n             etc.\r\n\r\n          -  Prior liver directed radiation treatment\r\n\r\n          -  Patients may have no serious medical illness, which may limit survival to less than 3\r\n             months\r\n\r\n          -  Patients may have no serious psychiatric illness/social situations which would limit\r\n             compliance with study requirements\r\n\r\n          -  Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for\r\n             nitrosoureas or mitomycin C) prior to entering the study or those who have not\r\n             recovered from adverse events due to agents administered more than 4 weeks earlier\r\n\r\n          -  Patients may not be receiving any other study agents\r\n\r\n          -  Uncontrolled intercurrent illness including, but not limited to ongoing or active\r\n             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac\r\n             arrhythmia.\r\n      ","sponsor":"Massachusetts General Hospital","sponsor_type":"Other","conditions":"Liver Cancer","interventions":[{"intervention_type":"Radiation","name":"Radiation: Proton Beam Irradiation","description":"Given once a day, 5 days a week, for 3 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"2 Year Local Control Rate","time_frame":"2 years","description":"The percentage of participants with local control after two years as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. The duration of control was measured from the start of treatment. Local control is the absence of local failure. Local Failure is defined as evidence of tumor growth/regrowth in any direction beyond that present of the pre-treatment imaging studies in the treated lesion(s)."},{"outcome_type":"primary","measure":"Median Overall Survival","time_frame":"5 years","description":"The median survival time in months as measured from the start of treatment until death due to any cause or until the participants is censored. Participants are censored at the date of their last follow-up."},{"outcome_type":"secondary","measure":"Number of Participants With Treatment Related Adverse Events ≥ Grade 3","time_frame":"2 years","description":"Summary of the proton radiation related grade 3 or greater adverse events that participants experienced. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE v3)."},{"outcome_type":"secondary","measure":"Patterns of Failure","time_frame":"2 years","description":"A summary of the patterns of treatment failure, shown as the number of participants that fall into each category at the end of study follow-up"}]}
{"nct_id":"NCT01116466","start_date":"2009-08-31","phase":"N/A","enrollment":5,"brief_title":"Clinical Study to Evaluate the Implantation of the ActiGait Drop Foot Stimulator System","official_title":"Clinical Study to Evaluate the Implantation of the ActiGait Drop Foot Stimulator System","primary_completion_date":"2010-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-03-31","last_update":"2021-08-26","description":"The objective of this study is to evaluate the efficacy and safety of surgical procedure involving ActiGait - implantable drop foot stimulator.","other_id":"PB-SA844-100","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  have a single sided hemiparesis persisting for more than 6 months due to a\r\n             cerebro-vascular accident (CVA).\r\n\r\n          -  be fully grown-up.\r\n\r\n          -  have the ability to walk 20 meters in less than 2 minutes with or without walking aid\r\n             but without the help of another person.\r\n\r\n          -  have a reduced speed of walking.\r\n\r\n          -  have the ability to stand upright with both heels touching the floor while hip and\r\n             knee are in neutral position.\r\n\r\n          -  have a passive range of movement of the affected ankle joint of at least 30 degrees.\r\n\r\n          -  have a positive response to surface electrical stimulation of the peroneal nerve -\r\n             i.e. muscle contraction which results in dorsiflexion of the ankle and improved gait.\r\n\r\n          -  male or female older than 18 years of age.\r\n\r\n          -  have signed written Informed consent to participate in the study.\r\n\r\n          -  is willing and able to follow all study procedures including attendance at clinics for\r\n             scheduled study visits.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  peripheral nerve damage of the affected leg.\r\n\r\n          -  severe or uncontrolled diabetes with peripheral nerve involvement.\r\n\r\n          -  poor skin condition on the affected leg.\r\n\r\n          -  a thickness of subcutaneous fat exceeding 3.5 cm in the region of the implant.\r\n\r\n          -  inability to walk 100 meters without stopping prior to CVA (with or without a walking\r\n             aid, but without the help of another person).\r\n\r\n          -  poorly controlled epilepsy.\r\n\r\n          -  need of Ankle Foot Orthosis (AOF) to maintain ankle stability.\r\n\r\n          -  concomitant medical and psychological conditions which would limit the success of the\r\n             ActiGait system such as: active degenerative diseases of the back and lower limbs,\r\n             visuo-spatial neglect, or drug abuse, personality disorders or poor cognitive\r\n             function.\r\n\r\n          -  concomitant medical and psychological conditions which would compromise the safety of\r\n             the patient in connection with the implantation and use of the ActiGait system, such\r\n             as: severe cardiac disease, uncontrolled hypertension or history of malignancy within\r\n             the preceding five years.\r\n\r\n          -  other active implanted devices such as demand pacemakers or implanted defibrillators,\r\n             as mutual electromagnetic interference may distort the efficacy of both systems and\r\n             expose the patient to dangerous situations.\r\n\r\n          -  history of falls greater than once a week.\r\n\r\n          -  pregnancy and lactation. Women of childbearing potential must maintain effective\r\n             contraception during the study period, as judged by the investigator.\r\n\r\n          -  previous participation in this study\r\n\r\n          -  participation in an investigational drug trial within 4 weeks prior to enrolment.\r\n\r\n          -  requirement of an interpreter\r\n\r\n          -  use of external FES system to assist walking four weeks prior to enrolment\r\n\r\n          -  MRI of the affected thigh that is inconsistent with safe implantation of the ActiGait\r\n\r\n          -  history of falls greater than once a week.\r\n\r\n          -  pregnancy and lactation. Women of childbearing potential must maintain effective\r\n             contraception during the study period, as judged by the investigator.\r\n\r\n          -  previous participation in this study.\r\n\r\n          -  participation in an investigational drug trial within 4 weeks prior to enrolment.\r\n\r\n          -  requirement of an interpreter.\r\n\r\n          -  anatomic situation of the common peroneal nerve identified by pre-surgical MRI that\r\n             could compromise the success of ActiGait).\r\n      ","sponsor":"Otto Bock Healthcare Products GmbH","sponsor_type":"Industry","conditions":"Stroke|Hemiplegia","interventions":[{"intervention_type":"Device","name":"Device: ActiGait","description":"ActiGait - implantable drop foot stimulator"}],"outcomes":[{"outcome_type":"primary","measure":"Distance Walked in 6 Minutes","time_frame":"Baseline, 6 and 12 weeks post-implantation","description":"The test assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity (endurance). At baseline this test was done with subject's conventional walking aid. At 6 and 12 weeks post-implantation this was done with and without stimulation."},{"outcome_type":"secondary","measure":"Walking Speed During 10 Meter Gait Test","time_frame":"Baseline, 6 and 12 weeks post-implantation","description":"The test assesses walking speed in meters per second over a short duration. At baseline this test was done with subject's conventional walking aid. At 6 and 12 weeks post-implantation this was done with and without stimulation."},{"outcome_type":"secondary","measure":"Canadian Occupational Performance Measure (COPM) Score","time_frame":"Baseline,12 weeks post-implantation","description":"A semi-structured interview is conducted in order to identify subject's limitations with daily occupations of importance in categories self-care, productivtiy or leisure. The subject is then asked to rate the imporance of each of the occupations using a 10-point rating scale. Afterwards the subject chooses up to 5 of the most important occupations (problems) (basis for identifying intervention goals). The subject is asked to use a 10 point scale to rate level of performance and satisfaction with performance for each of the five identified problems. Average COPM performance score and satisfaction score are calculated. The scores range between 1 and 10, where 1 indicates poor performance and low satisfaction, respectively, while 10 indicates very good performance and high satisfaction."},{"outcome_type":"secondary","measure":"Four Square Step Test (FSST)","time_frame":"Baseline, week 12 post-implantation","description":"It is a test of dynamic balance that clinically assesses the person's ability to step over objects forward, sideways, and backwards. The patient's time to perform the test is measured which shorter time representing better performance. At baseline this test was done with subject's conventional walking aid. At 12 weeks post-implantation it was done with and without stimulation."},{"outcome_type":"secondary","measure":"Nerve Conduction Velocity of the Peroneal Nerve","time_frame":"Baseline, week 12 post-implantation","description":"Measured: Nervus peroneus communis (CPN) and Nervus peroneus superficialis (SPN)"},{"outcome_type":"secondary","measure":"Change in MRI of Affected Leg and Implant Post-implantation","time_frame":"Week 2 post-implantation","description":"MRI will be conducted to evaluate the impact of the implant on the common peroneal nerve (e.g. positioning of the nerve cuff along the nerve, path of the lead wire and the common peroneal nerve, estimation of the cross-sectional area of the common peroneal nerve compared to the pre-operative MRI recording, etc.).\r\nThe outcome will be quantified by surgeon's judgement whether the final implant position is consistent with safe application of the ActiGait® implant as described in the manufacturer's surgical manual. Number of safe and successful implantations will be counted."}]}
{"nct_id":"NCT02314637","start_date":"2009-08-31","phase":"Phase 3","enrollment":240,"brief_title":"Long-term Safety Study of MP-513 as Monotherapy or in Combination With Sulfonylurea in Japanese Type 2 Diabetic Patients","official_title":"Long-term Safety Study of MP-513 as Monotherapy or in Combination With Sulfonylurea in Japanese Patients With Type 2 Diabetes Mellitus","primary_completion_date":"2011-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-07-31","last_update":"2015-08-20","description":"The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) as monotherapy or in combination with Sulfonylurea (glimepiride) in Japanese patients with type 2 Diabetes for 52 weeks administration.","other_id":"3000-A8","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  In case of combination therapy with Sulfonylurea, patients who has been receiving a\r\n             stable dose and regimen of sulfonylurea for diabetes over 12 weeks before\r\n             administration of investigational drug\r\n\r\n          -  Patients who are under dietary management and taking therapeutic exercise for diabetes\r\n             over 12 weeks before administration of investigational drug\r\n\r\n          -  HbA1c criteria:\r\n\r\n               -  monotherapy: 6.9% - 10.5%\r\n\r\n               -  combination therapy with Sulfonylurea: 7.4 - 10.5%\r\n\r\n          -  Patients who were not administered diabetes therapeutic drugs prohibited for\r\n             concomitant use within 12 weeks before administration of investigational drug.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or\r\n             secondary diabetes (Cushing disease, acromegaly, etc)\r\n\r\n          -  Patients who are accepting treatments of arrhythmias\r\n\r\n          -  Patients with serious diabetic complications\r\n\r\n          -  Patients who are the excessive alcohol addicts\r\n\r\n          -  Patients with severe hepatic disorder or severe renal disorder\r\n\r\n          -  Patients who are pregnant, lactating, and probably pregnant patients, and patients who\r\n             can not agree to contraception\r\n      ","sponsor":"Mitsubishi Tanabe Pharma Corporation","sponsor_type":"Industry","conditions":"Type 2 Diabetes Mellitus","interventions":[{"intervention_type":"Drug","name":"Drug: Teneligliptin + Sulfonylurea","description":"Teneligliptin for 52 weeks in combination with sulfonylurea"},{"intervention_type":"Drug","name":"Drug: Teneligliptin","description":"Teneligliptin for 52 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants With Adverse Events","time_frame":"52 weeks","description":"Treatment-emergent adverse events (TEAE) were defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after receiving the last dose of study drug."},{"outcome_type":"secondary","measure":"Change From Baseline in HbA1c at Week 52","time_frame":"Baseline and Week 52"},{"outcome_type":"secondary","measure":"Change From Baseline in Fasting Plasma Glucose at Week 52","time_frame":"Baseline and Week 52"}]}
{"nct_id":"NCT02586181","start_date":"2009-08-31","phase":"N/A","enrollment":93,"brief_title":"Effect of 1 Year Vitamin D or D Plus B-vitamins on Bone Markers in Elderly People (KnoVIB)","official_title":"Effect of 1 Year Vitamin D or D Plus B-vitamins on Bone Markers in Elderly People","primary_completion_date":"2011-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-07-31","last_update":"2019-04-04","description":"The standard recommendation to prevent osteoporosis is to supplement low doses of vitamin D and calcium. Hyperhomocysteinemia has been related to increased risk of osteoporosis.","other_id":"Vitamins and bone markers","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  age> 50 years,\r\n\r\n          -  male and female\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  renal dysfunction,\r\n\r\n          -  recent stroke or coronary event within the last 3 months,\r\n\r\n          -  current cancer,\r\n\r\n          -  antifolate treatment,\r\n\r\n          -  ileum resection,\r\n\r\n          -  existing B vitamins supplementation,\r\n\r\n          -  megaloblastic anemia,\r\n\r\n          -  osteoporotic patients treated with pharmacological doses of vitamin D or\r\n             antiosteoporotic drugs.\r\n\r\n        Termination criteria were:\r\n\r\n          -  indication for a high-dose vitamin B supplementation,\r\n\r\n          -  coronary or vascular event,\r\n\r\n          -  or surgical procedures during the study.\r\n      ","sponsor":"Universitt des Saarlandes","sponsor_type":"Other","conditions":"Nutritional Supplement Toxicity","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Vitamin D and Calcium","description":"a combination of dietary supplement including \"all\" 1200 IE Vitamin D3 plus 800 mg Calcium Carbonate\r\n1200 IE Vitamin D3 plus 800 mg Calcium Carbonate\r\nArm: Experimental: Vitamin D, Calcium, Vitamins B9, B6, B12\r\n1200 IE Vitamin D3 plus 800 mg Calcium Carbonate plus 0,5mg Folic acid, 50 mg B6, 0,5 mg B12"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Vitamin D, Calcium, Vitamins B9, B6, B12","description":"a combination of dietary supplement including \"all\" 1200 IE Vitamin D3 plus 800 mg Calcium Carbonate plus 0,5mg Folic acid, 50 mg B6, 0,5 mg B12"}],"outcomes":[{"outcome_type":"primary","measure":"Changes in bone formation markers","time_frame":"baseline, 6 and 12 months","description":"Concentrations of bone formation markers in plasma [OC (ng/ml), BAP (U/L)]: are measured: if all are increased indicate enhanced bone formation"},{"outcome_type":"secondary","measure":"Changes in plasma choline and betaine","time_frame":"baseline and aftter 12 months","description":"plasma choline and betaine (all µmol/L): if both increased indicate saving betaine and choline"},{"outcome_type":"secondary","measure":"Changes in global DNA methylation","time_frame":"baseline and after 12 months","description":"global DNA methylation [line 1-methylation (expressed as %)]"},{"outcome_type":"secondary","measure":"Changes in gene-specific gene methylation","time_frame":"baseline and after 12 months","description":"After isolating DNA from whole blood, changes in methylation of targeted genes is studied (expressed as %)"},{"outcome_type":"secondary","measure":"Changes in TMAO","time_frame":"baseline and after 6 and 12 months","description":"Plasma concentrations of TMAO ((µmol/L) is measured"},{"outcome_type":"secondary","measure":"Changes in phospholipid concentration in plasma","time_frame":"baseline and after 12 months","description":"Plasma phospholipids ((µmol/L) are measured"},{"outcome_type":"secondary","measure":"Changes in concentrations of bone resorption markers","time_frame":"baseline, 6 and 12 months","description":"concentrations of bone resorption markers [plasma TRAP5b (U/L), urine DPD (nmol//mmol creatinine)]: if both are increased indicate enhanced bone resorption"},{"outcome_type":"secondary","measure":"Changes in plasma homocysteine concentrations","time_frame":"baseline, 6 and 12 months","description":"changes in plasma homocysteine (µmol/L) between the time points"},{"outcome_type":"secondary","measure":"Changes in plasma levels of folate","time_frame":"baseline, 6 and 12 months","description":"changes in serum and whole blood folate (nmol/L)"}]}
{"nct_id":"NCT00948870","start_date":"2009-08-31","phase":"N/A","enrollment":200,"brief_title":"Trial of Chinese Prescription Shugan Decoction on Irritable Bowel SyndromeDiarrhea Type","primary_completion_date":"2011-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-09-30","last_update":"2013-03-07","description":"The purpose of this study is to evaluate the efficacy and safety of the Chinese prescription Shugan decoction on irritable bowel syndromediarrhea type.","other_id":"SHTCM-002","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Clinical diagnosis of irritable bowel syndromediarrhea type\r\n\r\n          -  Male of female patients between 18-65 years old\r\n\r\n          -  Written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Discrepancy of irritable bowel syndrome\r\n\r\n          -  Diarrhea-type of irritable bowel syndrome combine with intestinal disease\r\n\r\n          -  Combined with severe heart, gallbladder, kidney, endocrine system, hemopoietic system\r\n             or nervous system disease.\r\n\r\n          -  Pregnancy or breast feeding women, or unwilling to have contraception.\r\n      ","sponsor":"Shanghai University of Traditional Chinese Medicine","sponsor_type":"Other","conditions":"Irritable Bowel Syndrome|Traditional Chinese Medicine","interventions":[{"intervention_type":"Drug","name":"Drug: Shugan decoction","description":"Decoction ,two times a day,one bag of decoction one time"}],"outcomes":[{"outcome_type":"primary","measure":"Symptoms and conditions of tongue and pulse","time_frame":"4 weeks"},{"outcome_type":"secondary","measure":"Indicates of liver and renal function","time_frame":"4 weeks"}]}
{"nct_id":"NCT02903498","start_date":"2009-08-31","phase":"Phase 2","enrollment":58,"brief_title":"The Maintenance Treatment of UFT in Advanced Gastric Cancer","official_title":"Phase II Study of the Maintenance Treatment of UFT (Uracil and Tegafur) After First-line","primary_completion_date":"2016-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-09-30","last_update":"2016-10-12","description":"The purpose of this study is to evaluate the efficacy and tolerability of the maintenance treatment of tegafur-uracil (UFT) after the standard first-line chemotherapy in advanced gastric cancer.","other_id":"UFT maintenance in GC","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically confirmed advanced or metastatic adenocarcinoma of the stomach\r\n\r\n          -  ECOG PS 0-2\r\n\r\n          -  At least one measurable or evaluable lesion in the first-line chemotherapy (5-FU based\r\n             regimen: ECF/EOF/EOX/FOLFOX/XELOX) with the efficacy evaluation of non-PD\r\n\r\n          -  Adequate hepatic,renal,heart, and hematologic functions (platelets 75109/L,\r\n             neutrophil1.5109/L, hemoglobin80 g/L, serum creatinine 1.5mg/dl, total bilirubin\r\n             1.5mg/dl, and serum transaminase2.5the ULN)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Receiving more or more than 2 regimens of chemotherapy\r\n\r\n          -  Pregnant or lactating women\r\n\r\n          -  Concurrent cancer\r\n\r\n          -  History of other malignancies except cured basal cell carcinoma of skin and carcinoma\r\n             in-situ of uterine cervix\r\n\r\n          -  Neuropathy, brain, or leptomeningeal involvement\r\n\r\n          -  Clinically relevant coronary artery disease or a history of a myocardial infarction\r\n             within the last 12 months or high risk/uncontrolled arrhythmia\r\n\r\n          -  Uncontrolled significant comorbid conditions and previous radiotherapy\r\n      ","sponsor":"Fudan University","sponsor_type":"Other","conditions":"Gastric Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: UFT","description":"UFT 360mg/m2 qd po d1-14, q3w"}],"outcomes":[{"outcome_type":"primary","measure":"Progression Free Survival (PFS)","time_frame":"six weeks","description":"PFS is calculated from the start of treatment to disease progression or death"},{"outcome_type":"secondary","measure":"Overall Survival (OS)","time_frame":"six weeks","description":"OS is calculated from the start to treatment to the death"},{"outcome_type":"secondary","measure":"Number of Participants with Adverse Events","time_frame":"six weeks"}]}
{"nct_id":"NCT00964418","start_date":"2009-08-31","phase":"Phase 1","enrollment":27,"brief_title":"A Trial Investigating the Effect of NN1250 in Young and Elderly Subjects With Type 1 Diabetes","official_title":"A Trial Investigating the Pharmacodynamic and Pharmacokinetic Properties of NN1250 in Young and Geriatric Subjects With Type 1 Diabetes","primary_completion_date":"2009-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-11-30","last_update":"2017-01-20","description":"This trial is conducted in Europe. The aim of this clinical trial is to investigate the blood glucose lowering effect of NN1250 (insulin degludec) in young and elderly subjects with type 1 diabetes.","other_id":"NN1250-1994","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female aged 18-35 years (both inclusive) (young group) or at least 65 years\r\n             (geriatric group)\r\n\r\n          -  Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months\r\n\r\n          -  Body mass index 18.0-28.0 kg/m^2 (both inclusive)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subject who has donated any blood or plasma in the past month or more than 500 mL\r\n             within 3 months prior to screening\r\n\r\n          -  Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent\r\n             per day)\r\n\r\n          -  Not able or willing to refrain from smoking and use of nicotine gum or transdermal\r\n             nicotine patches during the inpatient period\r\n      ","sponsor":"Novo Nordisk A/S","sponsor_type":"Industry","conditions":"Diabetes|Diabetes Mellitus, Type 1","interventions":[{"intervention_type":"Drug","name":"Drug: insulin degludec","description":"0.4 U/kg body weight injected s.c. (subcutaneously) once daily for 6 days"},{"intervention_type":"Drug","name":"Drug: insulin glargine","description":"0.4 U/kg body weight injected s.c. (subcutaneously) once daily for 6 days"}],"outcomes":[{"outcome_type":"primary","measure":"Area under the glucose infusion rate curve during one dosing interval at steady state (for NN1250)","time_frame":"0-24 hours (derived on treatment day 6)"},{"outcome_type":"secondary","measure":"Area under the NN1250 concentration-time curve during one dosing interval at steady state","time_frame":"0-24 hours (derived on treatment day 6)"}]}
{"nct_id":"NCT00963677","start_date":"2009-07-31","phase":"N/A","enrollment":55,"brief_title":"Nasotracheal Intubation Using Shikani Optical Stylet","official_title":"Shikani Optical Stylet for Nasotracheal Intubation Undergoing Oral and Maxillofacial Surgery, a Prospective Evaluation","primary_completion_date":"2010-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-11-30","last_update":"2012-05-03","description":"Difficult airways is still a challenging issue for the anesthesiologists in spite of the development of various techniques.Shikani optical stylet(SOS), combining the features of fiberoptic bronchoscope and a lightwand, has been used for orotracheal intubation with difficult airways. As compared with fiberoptic bronchoscope, SOS is less expensive, easy to learn and more durable. However, it remains elusive whether SOS can be used in the nasotracheal intubation in the oral and maxillofacial surgery, which normally requires the nasotracheal intubation. The present study evaluates the safety and efficacy of SOS for nasotracheal intubation in the oral and maxillofacial surgery requiring nasotracheal intubation.","other_id":"NSFC-30700790","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Elective non-cardiac surgery patients requiring intubation for the surgery. Age 18-70\r\n             ASA 1-3 Body Mass Index (BMI) < 40\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients confirmed with difficult ventilation;\r\n\r\n          -  Patients not suitable for nasal intubation\r\n      ","sponsor":"Central South University","sponsor_type":"Other","conditions":"Intubation; Difficult","interventions":[{"intervention_type":"Procedure","name":"Procedure: Nasotracheal Intubation through seeing optical stylet (SOS)","description":"Nasotracheal intubation using seeing optical stylet in the patients with the anticipated difficult intubation. Arm 1:routine anesthesia induction,0.1mg/kg midazolam, 3-8mcg/kg fentanyl, 0.08-0.15mg/kg vecuronium and 0.3mg/kg etomidate, Nasotracheal intubation with seeing optical shikani; Arms 2: Sevoflurane combined with oxyge, 0.3mg/kg Etomidate and 1-2mg/kg succinylcholine for intubation, nasotracheal intubation with seeing optical shikani"}],"outcomes":[{"outcome_type":"primary","measure":"Number of the Patients With Successful Nasotracheal Intubation","time_frame":"1 hour(peri-intubation time)","description":"After anesthesia induction, the patients were undergone nasotracheal intubation with SOS. Number for first time successful intubation was recorded. If the time for one attempt intubation exceeded more than 120 seconds, it would be regarded as failed intubation for this time intubation. If a patient could not be successfully intubated after three attempts, the patients would be viewed as a case failing nasotracheal intubation with SOS."},{"outcome_type":"secondary","measure":"Time for Nasotracheal Intubation With the Use of Shikani Optical Stylet","time_frame":"1 hour (peri-intubation time)","description":"The time of nasotracheal intubation was calculated from the SOS insertion to withdrawing the stylet from the endotracheal tube."}]}
{"nct_id":"NCT00927576","start_date":"2009-07-31","enrollment":265,"brief_title":"PC-Based Cognitive Rehabilitation for Traumatic Brain Injury (TBI)","official_title":"PC-Based Cognitive Rehabilitation for TBI","primary_completion_date":"2013-03-31","study_type":"Observational","rec_status":"Completed","completion_date":"2013-03-31","last_update":"2015-07-31","description":"The investigators evaluated whether it was possible to improve the measurement of memory, attention, and executive function in patients who have suffered traumatic brain injury through the use of computer-based testing. Note: the original design of the study was altered due to failure to recruit sufficient numbers of patients who were willing to undergo prolonged cognitive training.","other_id":"B6119-R","observational_model":"Ecologic or Community","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":78,"population":"Controls subjects of various ages (approximately 230), and TBI patients (approximately 30).","criteria":"\n        Inclusion Criteria:\r\n\r\n        Control subjects were required to meet the following inclusion criteria:\r\n\r\n          -  (a) fluency in the English language\r\n\r\n          -  (b) no current or prior history of bipolar disorder, mania, or schizophrenia\r\n\r\n          -  (c) no current substance abuse\r\n\r\n          -  (d) no concurrent history of neurologic disease known to affect cognitive functioning\r\n\r\n          -  (e) on a stable dosage of any required medication\r\n\r\n          -  (f) auditory functioning sufficient to understanding normal conversational speech and\r\n             visual acuity normal or corrected to 20/40 or better\r\n\r\n        Exclusion criteria:\r\n\r\n          -  History of TBI\r\n\r\n        Exclusion Criteria for TBI patients:\r\n\r\n          -  TBI patients had to meet the same inclusion criteria as the controls with the\r\n             exception that they were required to have a history of TBI. They also had to be in the\r\n             chronic phase, i.e., 1-4 yrs post-injury.\r\n\r\n          -  Exclusion criteria:\r\n\r\n               -  current substance abuse\r\n\r\n               -  current psychiatric diagnosis other than PTSD\r\n      ","sponsor":"US Department of Veterans Affairs","sponsor_type":"U.S. Fed","conditions":"Traumatic Brain Injury","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Digit span testing","description":"Testing of short-term verbal memory with digit span"},{"intervention_type":"Behavioral","name":"Behavioral: Spatial span testing","description":"Testing of short-term visuospatial memory with spatial span."},{"intervention_type":"Behavioral","name":"Behavioral: Finger tapping","description":"Testing motor speed with a finger tapping test."},{"intervention_type":"Behavioral","name":"Behavioral: Simple reaction time","description":"Testing the time to respond to the appearance of a visual stimulus."},{"intervention_type":"Behavioral","name":"Behavioral: Choice reaction time","description":"Testing the time needed to discriminate and respond to different visual stimuli."},{"intervention_type":"Behavioral","name":"Behavioral: Verbal fluency","description":"Evaluating how many words are produced in 90s."},{"intervention_type":"Behavioral","name":"Behavioral: Verbal list learning","description":"Evaluating short-term memory, learning, and memory interference in the recall of 12-word lists, presented three times. Evaluating long-term memory and recognition after a 20 min interval."},{"intervention_type":"Behavioral","name":"Behavioral: Trail making test","description":"Evaluating visuomotor speed and executive function in Trail Making Tests, A and B. In the first, subjects connect successive numbers with the mouse. In the second, they connect numbers and letters in alternation."},{"intervention_type":"Behavioral","name":"Behavioral: Design fluency","description":"Subjects create the maximal number of 4-line patterns in 90 s."},{"intervention_type":"Behavioral","name":"Behavioral: Questionnaire completion","description":"Question completion time is measured on each question of the Post-Traumatic Stress Disorder check list (PCL) and on the cognitive failures questionnaire."}],"outcomes":[{"outcome_type":"primary","measure":"Performance in TBI Patients and Controls","time_frame":"Subjects were tested in a single 2-hr session.","description":"Subjects were assessed on a set of cognitive tests. Here we describe the results on the simple reaction time test in which subjects respond as rapidly as possible to the computer-controlled occurrence of a visual stimulus by pressing a mouse button. Two control groups were used. One large control group underwent a single test to provide data from subjects with a broad range of age and education. The other, smaller, control group underwent three tests at weekly intervals to evaluate the test-retest reliability of the measure."}]}
{"nct_id":"NCT00938002","start_date":"2009-07-31","enrollment":37,"brief_title":"Study to Determine Quicker Methods of Diagnosing Pneumonia Caused by a Breathing Machine in Critically Ill Patients","official_title":"Rapid Bacterial Identification and Antibiotic Resistance Testing in Critically Ill Adults at Risk for Ventilator Acquired Pneumonia (VAP).","primary_completion_date":"2019-09-19","study_type":"Observational","rec_status":"Completed","completion_date":"2019-09-19","last_update":"2019-12-24","description":"Critically ill patients on a breathing machine are at risk of developing a type of pneumonia called Ventilator Acquired Pneumonia (VAP). The purpose of this study is to determine if regular lung rinses sent for microbiological testing can reduce the time to diagnose VAP. The study also plans to test the accuracy and speed of a new technology, using multiplexed automated digital microscopy, to identify the germs causing the VAP.","other_id":"09-0321","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"Critically ill ventilated patients","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Written, informed consent (by surrogate if unconscious or if altered mental status)\r\n\r\n          2.  18 years old\r\n\r\n          3. Admission to a Medical Intensive care unit\r\n\r\n          4. Orally/nasally intubated, evaluable within 72 h of initial intubation\r\n\r\n          5. Expected to remain mechanically ventilated for at least 48 h after the first study\r\n             procedure\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Previously documented cystic fibrosis\r\n\r\n          2. Diffuse bronchiectasis\r\n\r\n          3. Severe or massive hemoptysis\r\n\r\n          4. Presence of an advanced directive to withhold life-sustaining treatment\r\n\r\n          5. Morbid state or expected to survive less than 14 days because of an advanced co-morbid\r\n             medical condition\r\n\r\n          6. Participation in a clinical trial of any unlicensed drug or device within 30 days\r\n\r\n          7. Pregnant or Nursing\r\n      ","sponsor":"Denver Health and Hospital Authority","sponsor_type":"Other","conditions":"Ventilator Acquired Pneumonia","interventions":[{"intervention_type":"Diagnostic Test","name":"Diagnostic Test: Acceler8 Pheno"}],"outcomes":[{"outcome_type":"primary","measure":"Reduction in time to diagnosis and treatment of VAP in an at risk population","time_frame":"30 days"}]}
{"nct_id":"NCT01006642","start_date":"2009-07-31","enrollment":80,"brief_title":"Mucosal Barrier Defects in Functional Dyspepsia by Confocal Laser Endomicroscopy","official_title":"Minimal Changes of Gastric Mucosal Barrier in the Pathophysiologic Mechanisms of Functional Dyspepsia","primary_completion_date":"2010-03-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2010-07-31","last_update":"2009-11-03","description":"There has been recent interest into the potential role of mucosal barrier defects in the pathophysiology of functional gastrointestinal disorders (FGIDs). There has been evidence of increased intestinal permeability in patients of IBS,and abnormal tissue resistance in NERD. Although the mucosa of Functional dyspepsia (FD) patients is endoscopically and histologically \"normal,\" it contains ultrastructural changes, activated immune cells, along with evidence of an increased release of mediators leading to gastric dysfunction. There is now consistent evidence indicating that mucosal barrier defects allow the passage of an increased load of bacteria, antigens and toxins which, in turn evoke activation of mucosal immune responses involved in the FD symptom.","other_id":"2009SDU-QILU-G04","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":75,"population":"Patients with indications for upper-endoscopy in Qilu Hospital outpatient and inpatient\r\n        department are the study population of this study.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  patients meeting IBS diagnosis criteria and indications for endoscopy investigation.\r\n\r\n          -  Asymptomatic individuals for health surveillance or patients for follow up after\r\n             polypectomy.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Esophageal, gastric or duodenal cancer or other malignancy\r\n\r\n          -  History of esophagus, stomach, or duodenum surgery\r\n\r\n          -  Conditions that preclude safe biopsies (coagulopathy, haemophilia, esophageal\r\n             varices,and patients on warfarin and antiplatelets)\r\n\r\n          -  A history of bronchial asthma, or known allergy to fluorescein\r\n\r\n          -  Pregnant or breast-feeding (for females)\r\n\r\n          -  Below 18 or above 75 years of age\r\n\r\n          -  Severe co-morbidities\r\n\r\n          -  Unable or unwilling to give informed consent\r\n      ","sponsor":"Shandong University","sponsor_type":"Other","conditions":"Functional Dyspepsia","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Specific microscopic changes in the gastric mucosa as seen under the confocal endomicroscope","time_frame":"Within the 30 minutes after injection of fluorescein"},{"outcome_type":"secondary","measure":"the relationship among minimal changes, FD symptoms , neuropeptides and immune responses.","time_frame":"after the immunohistochemistry of biopsy"}]}
{"nct_id":"NCT00935272","start_date":"2009-07-31","phase":"N/A","enrollment":180,"brief_title":"Safety/Efficacy Study of Restylane in Lip Augmentation","official_title":"A Randomized, Evaluator-Blinded, No-Treatment-Controlled Study of the Effectiveness and Safety of Restylane in the Augmentation of Soft Tissue Fullness of the Lips","primary_completion_date":"2010-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-07-31","last_update":"2012-01-30","description":"To determine the safety and effectiveness of Restylane when used for lip augmentation.","other_id":"MA-1300-15","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Must meet established lip fullness criteria\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Allergic to injectable hyaluronic acid, local topical anesthetics or nerve blocking\r\n             agents; Conditions/procedures that could interfere with lip fullness evaluations\r\n      ","sponsor":"Medicis Global Service Corporation","sponsor_type":"Industry","conditions":"Lip Augmentation","interventions":[{"intervention_type":"Device","name":"Device: Restylane","description":"Restylane injections in the lips"},{"intervention_type":"Device","name":"Device: Non-Treatment","description":"Non- Treatment"}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of Participants With Response","time_frame":"Baseline and at 8 weeks","description":"Assessment of lip fullness augmentation after treatment with Restylane, as compared to no treatment, at week 8 as compared to baseline assessment. Response was determined by at least one grade improvement from baseline in the upper and lower lips using the Medicis Lip Fullness Scale (MLFS). The MLFS is a 5 number scale with grading: (1) Very Thin, (2) Thin (3) Medium (4) Full and (5)Very Full."},{"outcome_type":"secondary","measure":"Percentage of Participants With a Response","time_frame":"Baseline and at weeks 12, 16, 20 and 24","description":"Assessment of lip fullness augmentation after treatment with Restylane, as compared to no treatment, at post-baseline time points as compared to baseline assessment. Response was determined by at least one grade improvement from baseline in the upper and lower lips using the Medicis Lip Fullness Scale (MLFS). The MLFS is a 5 number scale with grading: (1) Very Thin, (2) Thin (3) Medium (4) Full and (5)Very Full."}]}
{"nct_id":"NCT00914667","start_date":"2009-07-31","phase":"Phase 1","enrollment":14,"brief_title":"The Effect Of Fesoterodine On Pharmacokinetics And Pharmacodynamics Of Warfarin In Healthy Subjects","official_title":"An Open-Label, Randomized, Two-Way Crossover Study To Evaluate The Steady-State Effect Of Fesoterodine On The Pharmacokinetics And Pharmacodynamics Of A Single Supratherapeutic Dose Of Warfarin In Healthy Subjects.","primary_completion_date":"2009-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-08-31","last_update":"2011-06-01","description":"This is an open-label, randomized, two-way crossover study to evaluate the steady-state effect of fesoterodine (8 mg QD) on the pharmacodynamics and pharmacokinetics of a single supratherapeutic dose of warfarin (25 mg) in healthy subjects.","other_id":"A0221079","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy male and/or female subjects between the ages of 18 and 55 years\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Not healthy subjects--subjects with acute or chronic medical or psychiatric conditions\r\n             or laboratory abnormality\r\n      ","sponsor":"Pfizer","sponsor_type":"Industry","conditions":"Urinary Bladder, Overactive","interventions":[{"intervention_type":"Drug","name":"Drug: warfarin","description":"Single Dose Warfarin 25 mg on Day 1"},{"intervention_type":"Drug","name":"Drug: Warfarin plus Fesoterodine","description":"Fesoterodine 8 mg ER tablets QD for 9 Days and Single Dose Warfarin 25 mg on Day 3"}],"outcomes":[{"outcome_type":"primary","measure":"Cmax and AUCinf for both S- and R-warfarin","time_frame":"8 days per period"},{"outcome_type":"primary","measure":"AUC_INR and INRmax","time_frame":"8 days per period"},{"outcome_type":"secondary","measure":"AUClast, Tmax and t½ for both S- and R-warfarin","time_frame":"8 days per period"},{"outcome_type":"secondary","measure":"AUC_PT and PTmax","time_frame":"8 days per period"},{"outcome_type":"secondary","measure":"Safety will be assessed by subjective symptoms/objective findings including physical examinations, clinical safety laboratory assessments, 12-lead ECGs, vital sign measurements and adverse event monitoring.","time_frame":"8 days per period"}]}
{"nct_id":"NCT00854074","start_date":"2009-07-31","phase":"N/A","enrollment":0,"brief_title":"Neurostimulation for the Treatment of Post-Operative Ileus","official_title":"Neurostimulation for the Treatment of Post-Operative Ileus","primary_completion_date":"2009-12-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2010-01-31","last_update":"2018-02-19","description":"The primary goal of this study is to validate the design of the ElectroCore RMS-1100 Resolution Motility System and the ability to safely place a stimulation electrode in the epidural space of the spine in a post-operative subject, and to evaluate the subject's ability to tolerate stimulation for up to 48 hours. The secondary goal is to confirm that the electrical signal being delivered via this electrode shows evidence of effectiveness in improving the functional GI motility in subjects experiencing post-operative paralytic ileus","other_id":"IL - 01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or Female, Age >18 years, < 65 years\r\n\r\n          -  Partial small or large bowel open resection with primary anastomosis\r\n\r\n          -  120 hours post-operative with no signs of functional bowel activity\r\n\r\n          -  Able to give Informed Consent\r\n\r\n          -  By Post-Op Day 5, patient care has involved at least 3 of the following conservative\r\n             therapies to minimize long term POI:\r\n\r\n             i. post-operative, patient controlled opioid analgesia ii. removal of intra-operative\r\n             nasogastric tube at time of surgery or on post-operative day 1 iii. advancement of\r\n             liquid diet iv. advancement of solid food v. ambulation vi. use of chewing gum\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnant\r\n\r\n          -  Undergoing surgery for repair of penetrating trauma injury, gangrene or ischemic bowel\r\n\r\n          -  Evidence of anastomotic leak, abdominal infection, sepsis, bowel perforation,\r\n             mechanical small bowel obstruction or metabolic derangement (e.g., low\r\n             potassium/magnesium)\r\n\r\n          -  Presence of existing implanted or external stimulator for pain or other indications\r\n             (including pacemaker)\r\n\r\n          -  Operative blood lost of > 500 cc\r\n\r\n          -  Significant scarring of the skin along the lower thoracic/lumbar spine or deformation\r\n             of thoracic spinal canal from congenital, developmental or traumatic causes, or\r\n             previous extensive spinal thoracic surgery other than diskectomy\r\n\r\n          -  Received a lumbar or thoracic epidural block placed immediately prior to surgery\r\n\r\n          -  Body Mass Index > 35\r\n\r\n          -  Unstable cardiac status\r\n\r\n          -  Severe hypertension\r\n\r\n          -  American Society of Anesthesiologists (ASA) Score greater than/equal to 3\r\n\r\n          -  On anti-coagulation therapy (other than aspirin) or has an underlying bleeding\r\n             disorder\r\n\r\n          -  Active or suspected pelvic infection\r\n\r\n          -  Unable to communicate perception of the stimulation\r\n\r\n          -  Significant surgical complications where in the view of the physician, participation\r\n             in the study could further complicate subject care (i.e. infection at surgical site,\r\n             deep venous thrombosis, respiratory complications, etc)\r\n\r\n          -  Treatment with Entereg (alvimopam) during post-operative period\r\n      ","sponsor":"ElectroCore INC","sponsor_type":"Industry","conditions":"Ileus","interventions":[{"intervention_type":"Device","name":"Device: ElectroCore RMS-1100 Resolution Motility System","description":"An electrical neurostimulation signal will be applied to the spine"}],"outcomes":[{"outcome_type":"primary","measure":"To validate the design of ElectroCore Resolution Motility System™ , to safely place a stimulation electrode in the epidural space of the spine in a post-operative subject, and to evaluate the subject's ability to tolerate stimulation for up to 48 hours","time_frame":"30 days"},{"outcome_type":"secondary","measure":"To confirm that the electrical signal being delivered via this electrode shows evidence of effectiveness in improving the functional motility in subjects experiencing post-operative paralytic ileus.","time_frame":"48 hours"}]}
{"nct_id":"NCT00930865","start_date":"2009-07-31","phase":"Phase 1","enrollment":42,"brief_title":"Study to Evaluate the Potential Pharmacokinetic Interaction and Pharmacodynamic Effects on Renal Parameters of Bumetanide (1mg) and Dapagliflozin (10 mg) When Co-administered in Healthy Subjects","official_title":"A Randomized, Open-Label, Parallel-group, Multiple-Dose Study to Evaluate the Potential Pharmacokinetic Interaction and Pharmacodynamic Effects on Renal Parameters of Bumetanide (1mg) and Dapagliflozin (10 mg) When Co-administered in Healthy Subjects","primary_completion_date":"2009-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-09-30","last_update":"2016-10-17","description":"To assess the potential pharmacokinetic (PK) interactions of bumetanide and dapagliflozin following multiple doses of 1 mg bumetanide and 10 mg dapagliflozin in healthy subjects","other_id":"MB102-057","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy subjects as determined by no clinically significant deviation from normal in\r\n             medical history, physical examination, ECGs, and clinical laboratory determinations\r\n\r\n          -  Body Mass Index (BMI) of 18 to 32 kg/m, inclusive. BMI = weight (kg)/ [height (m)]\r\n\r\n          -  Women of childbearing potential (WOCBP) must be using an adequate method of\r\n             contraception to avoid pregnancy throughout the study in such a manner that the risk\r\n             of pregnancy is minimized and men, ages 18 to 45\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for\r\n             the entire study period\r\n\r\n          -  Any significant acute or chronic medical illness\r\n\r\n          -  Current or recent (within 3 months) gastrointestinal disease\r\n\r\n          -  Current smoker or recent (within 1 month) history of regular tobacco use\r\n\r\n          -  Evidence of organ dysfunction or any clinically significant deviation from normal in\r\n             physical examination, vital signs, ECG or clinical laboratory determinations beyond\r\n             what is consistent with the target population\r\n\r\n          -  Abnormal urinalysis at screening\r\n\r\n          -  Glucosuria at screening\r\n\r\n          -  Abnormal liver functions tests (ALT, AST or total bilirubin > 10 % ULN)\r\n\r\n          -  Presence of edema on physical exam\r\n\r\n          -  History of diabetes mellitus\r\n\r\n          -  History of heart failure\r\n\r\n          -  History of renal insufficiency\r\n\r\n          -  History of chronic or recurrent UTI (defined as 3 occurrences per year) or UTI in the\r\n             past 3 months\r\n\r\n          -  Positive urine screen for drugs of abuse either at screening or before dosing\r\n\r\n          -  Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV-1,\r\n             -2 antibody\r\n\r\n          -  History of allergy to SGLT2 inhibitors, bumetanide (or related compounds)\r\n\r\n          -  History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)\r\n\r\n          -  Prior exposure to dapagliflozin within 3 months of Day -1\r\n\r\n          -  Exposure to any investigational drug or placebo within 4 weeks of Day -1\r\n\r\n          -  Use of any prescription drugs within 4 weeks or over-the-counter acid controllers\r\n             within 2 weeks prior to study drug administration\r\n\r\n          -  Use of any other drugs, including over-the-counter medications within 1 week and\r\n             herbal preparations, within 2 weeks prior to study drug administration\r\n\r\n          -  Use of an oral, injectable or implantable hormonal contraceptive agent within 3 months\r\n             of study drug administration\r\n      ","sponsor":"AstraZeneca","sponsor_type":"Industry","conditions":"Type 2 Diabetes Mellitus","interventions":[{"intervention_type":"Drug","name":"Drug: Bumetanide","description":"Tablets, Oral, 1 mg, Single Dose, 7 Days"},{"intervention_type":"Drug","name":"Drug: Dapagliflozin","description":"Tablets, Oral, 10 mg. Single Dose, 7 Days"}],"outcomes":[{"outcome_type":"primary","measure":"Exposure to the investigational drug will be measured to compare with and without the co-administration of other drugs","time_frame":"24 hours post-dose on Day 8 and 15"},{"outcome_type":"secondary","measure":"To assess the safety and tolerability of bumetanide and dapagliflozin following multiple oral doses of 1 mg bumetanide and 10 mg dapagliflozin, administered together, either simultaneously or after adaptation to either agent alone, in healthy subjects","time_frame":"during 14 days of dosing"},{"outcome_type":"secondary","measure":"Explore potential pharmacodynamic (serum/urine electrolytes) effects of bumetanide + dapagliflozin following multiple doses of 1 mg bumetanide + 10 mg dapagliflozin, administered together, either simultaneously or after adaptation to either agent alone","time_frame":"during 14 days of dosing"}]}
{"nct_id":"NCT00935116","start_date":"2009-07-31","phase":"Phase 4","enrollment":70,"brief_title":"Etoricoxib for Postoperative Pain After Thyroid Surgery","official_title":"Effect of the Administration of Etoricoxib on Postoperative Pain and Quality of Recovery in Patients Undergoing Thyroid Surgery","primary_completion_date":"2010-09-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2010-09-30","last_update":"2009-07-08","description":"The purpose of the study is evaluate the analgesic efficacy and safety profile of the Cox-2 specific analgesic Etoricoxib (arcoxia) when administrated pre and postoperatively for controlling pain in adult patients undergoing thyroid surgery. Patients will be followed up in the immediate postoperative period, during the first postoperative (POD) day and in POD 2, 3 and 7. It is expected that with the addition of Etoricoxib, patients will experience less pain during the overall postoperative period and also a better quality of recovery when compared with the traditional analgesic regimen.","other_id":"AR001cl","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  age >18 and <70 years\r\n\r\n          -  body weight within normal ranges\r\n\r\n          -  ability to understand the use of pain assessment scales and the PCA device\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  known allergy to any of the drugs utilized\r\n\r\n          -  contraindication to opioid and non-opioid analgesic drugs\r\n\r\n          -  a history of bleeding disorders, peptic ulceration or anticoagulant use within the\r\n             last month\r\n\r\n          -  pregnant or breast-feeding patients\r\n\r\n          -  history of known or suspected drug abuse or patients who had taken NSAIDs within 24 h\r\n             prior to surgery\r\n      ","sponsor":"Hospital Padre Hurtado","sponsor_type":"Other","conditions":"Acute Pain","interventions":[{"intervention_type":"Drug","name":"Drug: etoricoxib","description":"G1 (CONTROL): Oral NSAID (diclofenac, three times a day) administrated pre-operatively and for 3 days after surgery.\r\nG2: Etoricoxib 120 mg, pre and post-operatively for 3 days after surgery"}],"outcomes":[{"outcome_type":"primary","measure":"Maximum pain scores during postoperative period","time_frame":"every 6 hours, 24hours,48hours,72hours."},{"outcome_type":"secondary","measure":"Total amount of rescue analgesics","time_frame":"24hours, 48hours, 72hours."}]}
{"nct_id":"NCT00855088","start_date":"2009-07-31","phase":"Phase 1","enrollment":13,"brief_title":"Study in Healthy Males to Measure Darunavir and Etravirine in Blood, Seminal Fluid, and Rectal Tissue","official_title":"A Phase IV, Open Label Study in Healthy Male Subjects to Investigate the Extent of Darunavir/Ritonavir and Etravirine Exposure in Blood, Seminal Fluid, and Rectal Mucosal Tissue Following Single and Multiple Dosing of Darunavir/Ritonavir and Etravirine","primary_completion_date":"2010-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-02-28","last_update":"2011-05-13","description":"This study is being conducted to look at how the body handles the drugs darunavir and etravirine. It will measure the amount of darunavir and etravirine in blood, semen, and in the rectum of men. The aim is to understand how much of the drug (taken by mouth) reaches the reproductive and intestinal tracts. It is believed that the presence of this drug in these areas may be beneficial in preventing the AIDS virus (HIV) from being passed from one person to another. The study will take samples of blood, semen and rectal mucosal tissue to measure drug levels. This study will also collect information on side effects.","other_id":"UNC IRB 08-0419","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":49,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy male subjects between the ages of 18 and 49 years, inclusive, with intact\r\n             genital tract and gastrointestinal tract. (Healthy is defined as no clinically\r\n             relevant abnormalities identified by a detailed medical history, full physical\r\n             examination, including blood pressure and pulse rate measurement, 12-lead ECG for\r\n             individuals >35yo and clinical laboratory tests).\r\n\r\n          -  Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >/=50\r\n             kg (110 lbs).\r\n\r\n          -  Evidence of a personally signed and dated informed consent document indicating that\r\n             the subject has been informed of all pertinent aspects of the trial.\r\n\r\n          -  Willing and able to comply with scheduled visits, treatment plan, laboratory tests,\r\n             and other trial procedures.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Evidence or history of clinically significant hematological, renal, endocrine,\r\n             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or\r\n             allergic disease (including drug allergies, but excluding untreated, asymptomatic,\r\n             seasonal allergies at time of dosing).\r\n\r\n          -  Subjects with a history of having a gastrectomy, colostomy, ileostomy, or any other\r\n             procedure altering the gastrointestinal tract.\r\n\r\n          -  Subjects with inflammatory bowel diseases (ulcerative colitis or Crohn's disease) and\r\n             have a clearly defined diagnosis of irritable bowel syndrome.\r\n\r\n          -  Subject who is unwilling to refrain from any sexual activity including intercourse and\r\n             masturbation for 72 hours prior study visit Day 1 and until discharge from the study.\r\n\r\n          -  Subject who is unwilling to refrain from rectal insertion of medical/recreation\r\n             devices and products and from receptive anal intercourse, for 72 hours before study\r\n             visit Day -1 and through 7 days after the last biopsy unless instructed otherwise by\r\n             the investigators.\r\n\r\n          -  History of febrile illness within 5 days prior to the first dose.\r\n\r\n          -  Any condition possibly affecting drug absorption (eg, gastrectomy).\r\n\r\n          -  A positive urine drug screen.\r\n\r\n          -  A positive result for HIV.\r\n\r\n          -  Active hepatitis B infection as defined by a positive Hepatitis B surface antigen\r\n             (HbsAg) OR a positive Hepatitis B core antibody with a negative Hepatitis B surface\r\n             antibody (HBsAb).\r\n\r\n          -  Active hepatitis C infection as defined by anti-hepatitis C virus serology (as\r\n             determined by multi-antigen EIA) and detectable HCV RNA.\r\n\r\n          -  A positive test for syphilis, gonorrhea, Chlamydia, HSV-2 (active lesions) or\r\n             trichomonas at screening.\r\n\r\n          -  History of regular alcohol consumption exceeding 14 drinks (1 drink = 5 ounces (150\r\n             mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of spirits) per week.\r\n\r\n          -  Participation in a clinical study within 4 months preceding the first dose of trial\r\n             medication.\r\n\r\n          -  Participation in a rectal biopsy study in the 12 months preceding the first dose of\r\n             trial medication.\r\n\r\n          -  Use of prescription or nonprescription drugs, vitamins and dietary supplements within\r\n             7 days or 5 half-lives (whichever is longer) prior to the first dose of trial\r\n             medication. Herbal supplements must be discontinued 14 days prior to the first dose of\r\n             trial medication. As an exception, acetaminophen may be used at doses of <\/= 1 g/day\r\n\r\n          -  Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.\r\n\r\n          -  History of sensitivity to heparin or heparin-induced thrombocytopenia.\r\n\r\n          -  Unwilling to abstain from alcohol use from 24 hours prior to the first dose of study\r\n             medication until after the follow-up visit.\r\n\r\n          -  Unwilling to abstain from cigarette smoking completely during inpatient\r\n             pharmacokinetic visits and unwilling to limit smoking to a maximum of 5 cigarettes per\r\n             day from 24 hours prior to the start of the study until study completion.\r\n\r\n          -  Unwilling or unable to comply with the dietary restrictions in regard to study drug\r\n             administration\r\n      ","sponsor":"University of North Carolina, Chapel Hill","sponsor_type":"Other","conditions":"HIV/AIDS|HIV Infections","interventions":[{"intervention_type":"Drug","name":"Drug: darunavir","description":"Healthy male volunteers will take darunavir 600 mg orally twice daily for 15 doses (8 days)"},{"intervention_type":"Drug","name":"Drug: Ritonavir","description":"Healthy male volunteers will take ritonavir 100 mg orally twice daily for 15 doses (8 days)"},{"intervention_type":"Drug","name":"Drug: Etravirine","description":"Healthy male volunteers will take etravirine 200 mg orally twice daily for 15 doses (8 days)"}],"outcomes":[{"outcome_type":"secondary","measure":"To generate matrix:blood plasma ratios of darunavir, ritonavir, and etravirine in semen and rectal tissue after single and multiple dosing","time_frame":"Study days 1, 7 and 8"},{"outcome_type":"primary","measure":"To generate individual pharmacokinetic parameters for darunavir, ritonavir, and etravirine in seminal plasma after single and multiple dosing","time_frame":"Study days 1, 7, and 8"},{"outcome_type":"primary","measure":"To generate composite pharmacokinetic parameters for darunavir, ritonavir, and etravirine in rectal tissue after single and multiple dosing","time_frame":"Study days 1 and 7 or 8"}]}
{"nct_id":"NCT00813358","start_date":"2009-07-10","phase":"N/A","enrollment":115,"brief_title":"Zenith TX2 Post-market Approval Study","official_title":"Zenith TX2 TAA Endovascular Graft Post-approval Study","primary_completion_date":"2020-02-14","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-03-23","last_update":"2021-06-04","description":"The Zenith TX2 Post-market Approval Study is a clinical trial approved by US FDA to further study the safety and effectiveness of the Zenith TX2 TAA Endovascular Graft in the treatment of thoracic aortic aneurysms.","other_id":"08-005","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Descending thoracic aortic aneurysm with diameter greater than or equal to 5.0 cm; or\r\n\r\n          -  Descending thoracic aortic aneurysm with a history of growth greater than or equal to\r\n             0.5 cm within the previous 12 months; or\r\n\r\n          -  Descending thoracic aortic degenerative or atherosclerotic ulcers greater than or\r\n             equal to 10 mm in depth and 20 mm in diameter\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Age less than 18 years\r\n\r\n          -  Other medical condition that may cause the patient to be non-compliant with the\r\n             protocol, confound the results, or is associated with limited life expectancy (i.e.,\r\n             less than 2 years)\r\n\r\n          -  Pregnant, breast-feeding, or planning on becoming pregnant within 24 months\r\n\r\n          -  Unwilling or unable to comply with the follow-up schedule\r\n\r\n          -  Inability or refusal to give informed consent\r\n\r\n          -  Simultaneously participating in another investigative device or drug study\r\n      ","sponsor":"Cook Research Incorporated","sponsor_type":"Industry","conditions":"Descending Thoracic Aortic Aneurysm","interventions":[{"intervention_type":"Device","name":"Device: Zenith TX2 TAA Endovascular Graft","description":"Endovascular treatment with the study device"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants With Freedom From Thoracic Aortic Aneurysm-related Mortality","time_frame":"5 years","description":"Thoracic aortic aneurysm-related mortality defined as death from any cause occurring within 30 days of the initial procedure or a secondary intervention; or any death determined by the independent clinical events committee to be causally related to the initial implant procedure, secondary intervention, or rupture of the treated aneurysm."}]}
{"nct_id":"NCT02869698","start_date":"2009-06-30","phase":"N/A","enrollment":192,"brief_title":"Spectral Dynamic Imaging of Cognitive Functions in Epileptic Patients Explored Stereoelectroencephalography","official_title":"Spectral Dynamic Imaging of Cognitive Functions in Epileptic Patients Explored","primary_completion_date":"2017-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-09-30","last_update":"2017-10-27","description":"This prospective research aims to develop the use of Spectral Imaging in addition Dynamics of cortical electrical stimulation to identify major anatomical and functional networks in epileptic patients candidates for surgery and explored by stereoencephalography, to minimize risk of post-surgical cognitive deficits.","other_id":"38RC09.012","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":6,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Drug-resistant partial epilepsy justifying a SEEG exploration\r\n\r\n          -  Intellectual capacities compatible with the award of cognitive tasks\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnant or lactating women\r\n\r\n          -  Patient deprived of liberty by a judicial or administrative\r\n\r\n          -  Major patient subject to a measure of legal protection\r\n      ","sponsor":"University Hospital, Grenoble","sponsor_type":"Other","conditions":"Epilepsy","interventions":[{"intervention_type":"Procedure","name":"Procedure: Spectral Dynamic Imaging"},{"intervention_type":"Device","name":"Device: Hybride electrode"},{"intervention_type":"Device","name":"Device: Macro electrode"}],"outcomes":[{"outcome_type":"primary","measure":"Functional brain mapping procedure using the EEG signal intracranial to minimize the risk of cognitive deficits associated with resection of the epileptogenic zone.","time_frame":"3 weeks"}]}
{"nct_id":"NCT00928239","start_date":"2009-06-30","phase":"N/A","enrollment":88,"brief_title":"Laparoscopic Sacropexy: Comparison of Mesh Attachment","official_title":"Laparoscopic Sacropexy: Randomized Clinical Trial to Compare Two Different Attachment Sites of the Dorsal Mesh at the Vaginal Insertion(MeshPlace)","primary_completion_date":"2011-06-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2014-06-30","last_update":"2009-06-25","description":"The purpose of this study is to compare postoperative complications and outcome two different attachment sites of the dorsal mesh support in laparoscopic sacropexy.","other_id":"KSA-MeshPlace","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  vaginal vault prolapse\r\n\r\n          -  recurrence of vaginal vault prolapse\r\n\r\n          -  signed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  rectocele\r\n\r\n          -  BMI>40\r\n      ","sponsor":"Kantonsspital Aarau","sponsor_type":"Other","conditions":"Vaginal Vault Prolapse","interventions":[{"intervention_type":"Procedure","name":"Procedure: laparoscopic sacropexy with mid vaginal attachment","description":"supracervical hysterectomy for uterine prolapse\r\nexposure of the anterior longitudinal ligament of sacrum and recto-vaginal septum posterior\r\ndissection up to ventrolateral part of the levator ani muscle\r\nAnterior dissection of vesico-vaginal fascia up to the lower third of the vagina below the trigonum of bladder\r\nTwo separate meshes, Gynemesh (Johnson&Johnson) a polypropylene mesh, for anterior and posterior compartment\r\nsuturing of posterior mesh caudally to levator ani muscle and proximally 4cm from the apex of the vagina or cervical stump\r\nplacement of anterior mesh underneath bladder and attachment to caudal part of the vagina and the apex\r\nsuturing together anterior and posterior mesh are sutured together at level of vaginal apex and attachment to longitudinal sacral ligament at level of S2"},{"intervention_type":"Procedure","name":"Procedure: laparoscopic sacropexy with caudal vaginal attachment","description":"supracervical hysterectomy for uterine prolapse\r\nexposure of the anterior longitudinal ligament of sacrum and recto-vaginal septum posterior\r\ndissection up to ventrolateral part of the levator ani muscle\r\nAnterior dissection of vesico-vaginal fascia up to the lower third of the vagina below the trigonum of bladder\r\nTwo separate meshes, Gynemesh (Johnson&Johnson) a polypropylene mesh, for anterior and posterior compartment\r\nsuturing of posterior mesh caudally to the levator ani muscle and proximally at caudal part of the vagina or cervical stump\r\nplacement of anterior mesh underneath bladder and attachment to caudal part of the vagina and the apex\r\nsuturing together anterior and posterior mesh are sutured together at level of vaginal apex and attachment to longitudinal sacral ligament at level of S2"}],"outcomes":[{"outcome_type":"primary","measure":"Rate of Postoperative Constipation","time_frame":"6 to 8 weeks postoperatively"}]}
{"nct_id":"NCT01419288","start_date":"2009-06-30","phase":"Phase 1","enrollment":8,"brief_title":"Treadmill Training With Lower Extremity Amputees","primary_completion_date":"2012-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-06-30","last_update":"2013-01-10","description":"Many people with a leg amputation have difficulty walking even after they have finished their rehabilitation. The purpose of this study is to see if a large amount of walking practice on a treadmill can improve functional abilities.","other_id":"2009-0573-1","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":21,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Leg amputation that is either below the knee, through the knee, or above the knee\r\n\r\n          -  Ability to walk with prosthetic\r\n\r\n          -  Comfortably fitted with a prosthesis for at least 6 months\r\n\r\n          -  Not currently receiving physical therapy for gait training\r\n\r\n          -  Able to tolerate a moderate intensity exercise program\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  People with severe cardiac or pulmonary disease that limits ability to exercise.\r\n\r\n          -  People with too much discomfort and/or pain that restricts their ability to walk.\r\n\r\n          -  People with active wounds on their residual limb or contralateral foot.\r\n\r\n          -  People who weigh more than 360lbs or are taller than 6'11\" as the unweighing system\r\n             can not support any greater load or height.\r\n      ","sponsor":"Stony Brook University","sponsor_type":"Other","conditions":"Traumatic Amputation of Lower Extremity","interventions":[{"intervention_type":"Other","name":"Other: Treadmill Training","description":"The program requires volunteer participants to attend 15 sessions over 10 to 12 weeks with a total time commitment of 13.5 hours. There is an initial testing session that includes an assessment of the participant's legs, balance, and walking abilities. The entire program includes 12 treadmill training visits that take place three times per week for four weeks, a post-training testing session one week after completion of the training, and a follow-up testing session four weeks after completion of the training."}],"outcomes":[{"outcome_type":"primary","measure":"Change from Baseline in 6-minute walk test","time_frame":"Baseline, after training, 1 month follow-up","description":"Participants will be assessed 3 times: Baseline, 1 week after completing the training protocol, and then 1 month after completing the training protocol"}]}
{"nct_id":"NCT00852202","start_date":"2009-06-30","phase":"Phase 2","enrollment":234,"brief_title":"Safety and Efficacy of RGH-188 (Cariprazine) in Bipolar Depression","official_title":"A Double-blind, Placebo-controlled Study of RGH-188 (Cariprazine) in Bipolar Depression","primary_completion_date":"2010-06-15","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-06-15","last_update":"2018-08-23","description":"The purpose of this study is to evaluate the efficacy, safety, and tolerability of cariprazine in the treatment of outpatients with bipolar depression.","other_id":"RGH-MD-52","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Men and women, 18-65 years old\r\n\r\n          -  Currently meet the DSM-IV-TR criteria for Bipolar I or II Disorder without psychotic\r\n             features, with a current depressive episode\r\n\r\n          -  A verified previous manic, hypomanic, or mixed episode\r\n\r\n          -  Score of 20 or higher on the HAMD-17\r\n\r\n          -  Score of 2 or higher on Item 1 of the HAMD\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Score greater than 12 on the Young Mania Rating Scale\r\n\r\n          -  Eight or more episodes of a mood disturbance (depression, mania, hypomania, or mixed\r\n             state) within the 12 months prior to Visit 1\r\n\r\n          -  Principal DSM-IV-TR-based diagnosis of an axis I disorder other than bipolar disorder\r\n             (a secondary diagnosis of comorbid Generalized Anxiety Disorder, Social Anxiety\r\n             Disorder, or specific phobias is acceptable)\r\n      ","sponsor":"Forest Laboratories","sponsor_type":"Industry","conditions":"Bipolar Depression","interventions":[{"intervention_type":"Drug","name":"Drug: cariprazine","description":"Drug: cariprazine (1.5 - 3.0 mg/day)"},{"intervention_type":"Drug","name":"Drug: cariprazine","description":"Drug: cariprazine (0.25 - 0.75 mg/day)"},{"intervention_type":"Drug","name":"Drug: placebo","description":"placebo capsules, oral administration, once daily dosing"}],"outcomes":[{"outcome_type":"primary","measure":"Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)","time_frame":"Baseline to Week 8","description":"The patient is rated on a scale from 0-6 on 10 items. Apparent sadness, reported sadness, lassitude, pessimistic thoughts, inner tension, suicidal thoughts, reduced sleep and appetite, concentration difficulties, inability to feel. The overall MADRS score ranges from 0-60, with 0 meaning no symptoms and score of 60 meaning maximum severity."},{"outcome_type":"secondary","measure":"Change in Baseline in Clinical Global Impressions-Improvement ( CGI-I )","time_frame":"Baseline to Week 8","description":"The patient was rated on a scale from 1 to 7, with 1 indicating the patient was very much improved and 7 indicating that the patient was very much worse."}]}
{"nct_id":"NCT00860496","start_date":"2009-06-30","phase":"Phase 1","enrollment":24,"brief_title":"A Phase I Open-Label Study of the Effects of Tacrolimus and Cyclosporine on CP-690,555 in Healthy Volunteers","official_title":"A Phase I, Open Label, Fixed-Sequence Study to Estimate the Effect of Tacrolimus and Cyclosporine on the Pharmacokinetics of CP-690,550 in Healthy Volunteers","primary_completion_date":"2009-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-08-31","last_update":"2009-08-13","description":"A new immunosuppressive drug, based on the inhibition of important enzymes in the immune system, called JAK, is being developed by Pfizer to prevent transplant rejection. Since many treatments for transplant rejection may be administered together, this research study will analyze the effects of common transplant rejection therapies, Tacrolimus and Cyclosporine, on the JAK inhibitor, CP-690,550.","other_id":"A3921020","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":21,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy males between 21 and 55 years, inclusive.\r\n\r\n          -  Healthy females of non-childbearing potential between 21 and 55 years, inclusive.\r\n\r\n          -  Total body weight greater than 132 pounds.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Evidence or history of clinically significant disease\r\n\r\n          -  Females of childbearing potential\r\n      ","sponsor":"Pfizer","sponsor_type":"Industry","conditions":"Healthy Volunteers","interventions":[{"intervention_type":"Drug","name":"Drug: CP- 690,550 and Tacrolimus","description":"10 mg, single dose of CP-690,550 on Day 1 5 mg, every 12 hours of Tacrolimus on Days 1-8 10 mg, single dose of CP-690,550 on Day 8"},{"intervention_type":"Drug","name":"Drug: CP- 690,550 and Cyclosporine","description":"10 mg, single dose of CP-690,550 on Day 1 200 mg, every 12 hours of Cyclosporine on Days 1-6 10 mg, single dose of CP-690,550 on Day 6"}],"outcomes":[{"outcome_type":"primary","measure":"Effect of multiple dose Tacrolimus and Cyclosporine on the pharmacokinetics of a single oral dose of CP-590,550 in healthy volunteers","time_frame":"9 days"},{"outcome_type":"secondary","measure":"Evaluate the safety and tolerability of a single oral dose of CP-690,550 when co-administered with Tacrolimus or Cyclosporine","time_frame":"9 days"}]}
{"nct_id":"NCT00931216","start_date":"2009-06-30","phase":"N/A","enrollment":1172,"brief_title":"Integration of HIV Care and Treatment Into Antenatal Care in Migori District, Kenya","official_title":"Integration of HIV Care and Treatment Into Antenatal Care in Migori District, Kenya","primary_completion_date":"2012-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-03-31","last_update":"2012-04-10","description":"This study seeks to determine the most effective way to reach and provide pregnant women with accessible, comprehensive, and high quality HIV care and treatment.","other_id":"KE.07.0055","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  FOR SITE INCLUSION:\r\n\r\n               -  Each site must provide ANC services\r\n\r\n               -  Each site must provide HIV testing services for pregnant women\r\n\r\n               -  Each site must have an average of at least 20 new ANC clients per month\r\n\r\n          -  FOR ENROLLMENT OF HIV-POSITIVE WOMEN:\r\n\r\n               -  All women testing HIV-positive at one of the 12 ANC clinics included in the study\r\n                  will be asked to participate in the study\r\n\r\n          -  FOR HEALTH PROVIDER INCLUSION IN INTERVIEWS:\r\n\r\n               -  Health care staff must work within the ANC clinic at selected facilities\r\n\r\n               -  Staff must be able to read and speak English well enough to complete the informed\r\n                  consent process, participate in a one-on-one in-depth interview in English and\r\n                  complete a brief self-administered questionnaire\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  FOR SITE EXCLUSION:\r\n\r\n               -  If all of inclusion criteria are not met the site will be excluded\r\n\r\n               -  If site is already providing integrated ANC/HIV care services\r\n\r\n          -  FOR HEALTH PROVIDER INCLUSION IN INTERVIEWS:\r\n\r\n               -  If all of inclusion criteria are not met the site will be excluded\r\n      ","sponsor":"University of California, San Francisco","sponsor_type":"Other","conditions":"HIV Infections","interventions":[{"intervention_type":"Procedure","name":"Procedure: Integrated ANC, PMTCT, HIV services","description":"Of the 12 study clinics, 6 will be randomized to receive the intervention. At these 6 facilities, health care providers within the ANC department will be trained to also provide HIV/PMTCT care. Women testing positive within ANC clinics at integrated facilities will receive ANC, PMTCT and HIV services within the same visit/same service provider rather than being referred for HIV care and treatment."}],"outcomes":[{"outcome_type":"primary","measure":"Vertical transmission of HIV","time_frame":"3 months postpartum"},{"outcome_type":"secondary","measure":"Maternal HIV treatment outcomes","time_frame":"6 months, 1 year"},{"outcome_type":"secondary","measure":"Provider job satisfaction","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Infant HIV testing uptake","time_frame":"3 months postpartum"},{"outcome_type":"secondary","measure":"Patient enrollment, retention and adherence in HIV care and treatment","time_frame":"6 months, 1 year"}]}
{"nct_id":"NCT01040598","start_date":"2009-06-30","phase":"Phase 1","enrollment":19,"brief_title":"Identifying Responders to Xolair (Omalizumab) Using Eosinophilic Esophagitis as a Disease Model","official_title":"Identifying Responders to Xolair (Omalizumab) Using Eosinophilic Esophagitis as a Disease Model","primary_completion_date":"2011-12-31","study_type":"Interventional","rec_status":"Completed","last_update":"2012-03-14","description":"Eosinophilic Esophagitis(EoE) is a condition characterized commonly by vomiting, nausea, epigastric pain, dysphagia, heartburn and food impaction among other gastrointestinal symptoms along with obstructive esophageal symptoms in both pediatric and adult population. The pathology of this disease is postulated to be allergy mediated and the incidence of this disease is seen to parallel an increase in the incidence of allergies and asthma. Most of the current therapies for EoE are directed at decreasing esophageal allergic inflammation and mirror the treatment options for allergic asthma. Swallowed corticosteroids and elimination diets or elemental diets have shown variable efficacy is improving symptoms. However, specific pathophysiologic mechanism of EoE is still largely unknown and there is no definitive treatment that completely resolves symptoms and histological findings. Omalizumab is a recently developed anti-IgE antibody that has been shown to decrease the use of inhaled and oral corticosteroids and improve asthma related symptoms in patients with allergic asthma. In this study, Eosinophilic esophagitis is being used as a disease model to study the mechanism of action of monoclonal Anti-IgE antibody in vivo. The resolution of symptoms clinically, and histological changes (and improvements) in response to treatment with Xolair (omalizumab) in patients suffering from EoE will be determined. The primary objective of this open label, study is to determine mucosal markers that will predict responders to Omalizumab (Xolair).","other_id":"EE001","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":12,"maximum_age":76,"population":"","criteria":"\n        Inclusion criteria\r\n\r\n          -  Established diagnosis of eosinophilic esophagitis, determined by eosinophils >15/high\r\n             power field in the distal esophagus and/or microabscesses.\r\n\r\n          -  Patients should be on therapy either by food avoidance or swallowed steroids, with no\r\n             change in the food avoidance and steroid dose during therapy.\r\n\r\n          -  One active symptom of disease (epigastric pain, vomiting, nausea, dysphagia or\r\n             heartburn) at least 2 days of the week.\r\n\r\n          -  Failed response to proton pump inhibitors or a negative ph probe test or Negative\r\n             impedance study.\r\n\r\n          -  Males and females between ages 12-76 years.\r\n\r\n        Exclusion criteria\r\n\r\n          -  Patients with gastrointestinal reflux disease.\r\n\r\n          -  Eosinophilic disease in the stomach or duodenum.\r\n\r\n          -  Peripheral eosinophil counts >1500 (hyper eosinophilic syndrome).\r\n\r\n          -  Women of childbearing potential not using two forms of contraception method(s)\r\n             including but not limited to condoms, diaphragm, oral contraceptive pills, other\r\n             hormonal methods, intrauterine device or tubal ligation and vasectomy, as well as\r\n             women who are breastfeeding\r\n\r\n          -  Known sensitivity to study drug(s) or class of study drug(s).\r\n\r\n          -  Patients with severe medical condition(s) that in the view of the investigator\r\n             prohibits participation in the study (specify as required).\r\n\r\n          -  Use of any other investigational agent in the last 30 days.\r\n\r\n          -  Use of systemic or inhaled steroids within the past 1 month.\r\n\r\n          -  History of malignancy.\r\n\r\n          -  Require chronic immunosuppressive therapy including cyclosporine, methotrexate, etc.\r\n\r\n          -  Have been treated with Xolair within the 12 months prior to screening.\r\n\r\n          -  Patients with eosinophilic esophagitis in remission on swallowed steroids.\r\n\r\n          -  Patients with asthma taking inhaled steroids.\r\n\r\n          -  Serum IgE levels < 30 IU/l or > 700 IU/l\r\n      ","sponsor":"O & O Alpan LLC","sponsor_type":"Other","conditions":"Eosinophilic Esophagitis","interventions":[{"intervention_type":"Biological","name":"Biological: Omalizumab","description":"Omalizumab, an anti-IgE monoclonal antibody is dosed on the basis of subject's weight and IgE levels. It is administered as a subcutaneous injection every 2 weeks or 4 weeks based on the total dose required."}],"outcomes":[{"outcome_type":"primary","measure":"Our primary objective is to determine markers that will predict responders to Omalizumab(Xolair)","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"Secondary objectives will be determining the immunological changes in the tissue before and after treatment with Xolair (omalizumab)","time_frame":"12 weeks"}]}
{"nct_id":"NCT00927446","start_date":"2009-06-30","enrollment":40,"brief_title":"Endoscopy Screening for Esophageal Cancer","official_title":"Endoscopy Screening for Esophageal Neoplasm With Narrow Band Imaging in Patients With Head and Neck Cancer: A Controlled Tandem Endoscopy Trial","primary_completion_date":"2010-04-30","study_type":"Observational","rec_status":"Terminated","completion_date":"2010-04-30","last_update":"2010-10-19","description":"Patients with head and neck cancer frequently develop synchronous or metachronous esophageal malignancies. Previous studies have demonstrated the efficacy of endoscopic screening for esophageal cancer in head and neck cancer patients. The Narrow Band Imaging (NBI) system, an optical technology that enhances the visualization of superficial vascular network, may be superior to the conventional white light endoscopy for the detection of neoplastic lesions. However, whether the application of NBI improves the detection results have not been critically evaluated. This study aims to investigate the diagnostic value of the NBI system in the endoscopic screening for esophageal neoplastic lesions in patients with head and neck cancer.","other_id":"OMCP-98-006","observational_model":"Cohort","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients with tissue diagnosis of head and neck carcinoma","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  patients with tissue diagnosis of head and neck cancer\r\n\r\n          -  histopathology of head and neck cancer is carcinoma (including squamous cell\r\n             carcinoma, adenocarcinoma or undifferentiated)\r\n\r\n          -  aged more than 18 years old\r\n\r\n          -  agree to under go upper gastrointestinal endoscopy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  lack of written informed consent\r\n\r\n          -  the origin of head and neck cancer is metastatic\r\n\r\n          -  histopathology of head and neck cancer is not carcinoma (e.g., sarcoma, lymphoma, etc)\r\n\r\n          -  incomplete upper gastrointestinal endoscopy\r\n      ","sponsor":"Lotung Poh-Ai Hospital","sponsor_type":"Other","conditions":"Head and Neck Cancer","interventions":[{"intervention_type":"Procedure","name":"Procedure: Endoscopy screening with narrow band imaging","description":"Narrow Band Imaging (NBI) system, an optical technology that enhances the visualization of superficial vascular network, may be superior to the conventional white light endoscopy for the detection of neoplastic lesions."}],"outcomes":[{"outcome_type":"primary","measure":"Pathological interpretation of biopsy specimen for invasive cancer, carcinoma in-situ, or high-grade dysplasia","time_frame":"Within 3 days of endoscopy examination"},{"outcome_type":"secondary","measure":"Pathological interpretation of biopsy specimen for any grade of dysplasia","time_frame":"within 3 days of endoscopy examination"}]}
{"nct_id":"NCT00787839","start_date":"2009-06-30","enrollment":1939,"brief_title":"Opportunistic Screening for Prediabetes and Early Diabetes in Primary Care","official_title":"Screening for Prediabetes and Early Diabetes in Primary Care","primary_completion_date":"2012-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2012-12-31","last_update":"2015-04-27","description":"People who might have prediabetes or unrecognized diabetes will be screened for these problems at an outpatient visit. For screening, they will take a sugary drink containing 50 grams of glucose, and have a blood sample one hour later. The blood sample will be tested for glucose and A1c (a measure of blood glucose over the previous two months). They will also fill out questionnaires that ask about their health history and how they would feel about exercising and trying to lose weight if they are found to have prediabetes or diabetes. At a subsequent visit, they will have an oral glucose tolerance test (OGTT) - a blood sample, then a sugary drink containing 75 grams of glucose, and a repeat blood sample 2 hours later. We will evaluate the costs of finding out if people have prediabetes or diabetes. For people who are found to have these problems, we will also evaluate how well their doctors treat these problems.","other_id":"IIR 07-138","observational_model":"Cohort","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"initial primary study population will be drawn primarily from veterans receiving primary\r\n        care at the Decatur Clinic CBOC in metropolitan Atlanta, GA","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  veteran status,\r\n\r\n          -  ambulatory outpatient at Atlanta VA Medical Center,\r\n\r\n          -  visit to primary care clinic, AND\r\n\r\n          -  meet criteria for screening (age >= 45 years or other risk factors [body mass index\r\n             >=25 or hypertension or systolic blood pressure >=140 or HDL cholesterol <35 in men or\r\n             <45 in women or fasting triglycerides >250 or first-degree relative with diabetes or\r\n             minority race or minority ethnicity or history of diabetes during pregnancy or history\r\n             of having a baby weighing >9 pounds or history of polycystic ovary syndrome])\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  known to have diabetes, OR\r\n\r\n          -  taking steroids OR pregnant, OR\r\n\r\n          -  not well enough to have worked during the previous week (actual employment not\r\n             necessary)\r\n      ","sponsor":"US Department of Veterans Affairs","sponsor_type":"U.S. Fed","conditions":"Type 2 Diabetes Mellitus|Prediabetic State","interventions":[{"intervention_type":"Other","name":"Other: Glucose challenge test","description":"At a first outpatient visit, at different times of the day and without a prior fast, subjects will have a 50 gram glucose drink followed by measurement of plasma and capillary glucose along with A1c one hour later. They will also fill out questionnaires. At a second outpatient visit, in the morning after fasting overnight, they will have a 75 gram oral glucose tolerance test."},{"intervention_type":"Other","name":"Other: Glucose tolerance test","description":"Subjects found to have diabetes or prediabetes on the initial glucose tolerance test may be requested to have a repeat glucose tolerance test and A1c."}],"outcomes":[{"outcome_type":"primary","measure":"Ability of Different Screening Tests Which Can be Performed Opportunistically (During Outpatient Visits -- at Any Time of Day, Regardless of Meal Status) to Predict Findings With the Oral Glucose Tolerance Test (in the Morning, After an Overnight Fast)","time_frame":"3 years","description":"Area under ROC curve (AROC) for prediction of diabetes (based on OGTT) and high-risk dysglycemia (based on OGTT, IGT with 2 hour OGTT glucose 140-199 mg/dl, and/or IFG with fasting glucose 110-125 mg/dl).\r\nROC curves are plots of (1-sensitivity) vs. (1-specificity) for all possible screening cutoffs, so a higher AROC indicates higher predictive accuracy. A perfect test would have an AROC of 1.00, while a test equivalent to tossing a coin (random) would have an AROC of 0.50; if confidence limits include 0.50, predictive accuracy is no better than chance.\r\nIt is important to appreciate that while AROC analysis can show the relative accuracy of different screening tests, and aid the selection of which test to use in clinical practice, such an analysis does not define what the optimal screening test cutoff is. Selection of the optimal cutoff generally requires consideration of other factors, such as costs and/or the clinical importance of having higher or lower sensitivity."},{"outcome_type":"secondary","measure":"Cost to Identify a Single Case of High-risk Dysglycemia or Previously Unrecognized Diabetes","time_frame":"3 years","description":"Cost was expressed as cost (dollars) to identify a single case, with cases defined as (i) diabetes or (ii) high-risk dysglycemia. Cost projections for screening were conducted from both Medicare and VA perspectives. All screening projections assumed follow-up testing with an OGTT if the screening test exceeded a 70% specificity cut-off."}]}
{"nct_id":"NCT00982085","start_date":"2009-06-30","enrollment":4000,"brief_title":"The Status of Asthma in the Korean Military Personnel","official_title":"The Status of Asthma in the Korean Military Personnel","primary_completion_date":"2010-02-28","study_type":"Observational","rec_status":"Unknown status","completion_date":"2010-03-31","last_update":"2009-09-22","description":"The aim of this study is to evaluate the status of allergic diseases in the Korean military personnel.","other_id":"Asthma Prevalence in ROK","observational_model":"Ecologic or Community","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"Male","population":"Korean Military personnel who resign in South Korea.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Korean military personnel who can respond questionnaire\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Person who refuse to participate in this study\r\n      ","sponsor":"Armed Forces Capital Hospital, Republic of Korea","sponsor_type":"Other","conditions":"Asthma","interventions":{},"outcomes":{}}
{"nct_id":"NCT00826670","start_date":"2009-06-30","phase":"Phase 4","enrollment":58,"brief_title":"Enterobacteriaceae Producing Extended-spectrum -lactamases (ESBL) Decolonization Study","primary_completion_date":"2012-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-08-31","last_update":"2012-08-07","description":"Multidrug-resistant Enterobacteriaceae producing extended-spectrum -lactamases (hereafter called ESBLs) have emerged as an important cause of bloodstream infection in hospitalized patients and urinary tract infections in the community. As is the case with other multidrug-resistant organisms chronic colonization is frequent, in the case of ESBLs mostly intestinal and urinary carriage. To the investigators knowledge no randomized, placebo-controlled clinical trial has been performed to study the efficacy of a systematic ESBL eradication strategy. Eradication of ESBL carriage would cause benefits for the individual patient - by reducing the risk of infection - and for the community - by reducing transmission. Even if eradication turns out to be impossible, transient suppression of ESBL might reduce the likelihood of transmission and thus still be beneficial from an ecologic perspective. The purpose of the proposed study is to test the hypothesis that the administration of a 10 day course of oral antibiotics active against ESBLs can lead to decolonization of ESBL carriage in hospitalized patients.","other_id":"08-161","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Patients can be enrolled into the study provided that all of the following criteria are\r\n        met:\r\n\r\n          1. Microbiologically documented rectal carriage of ESBL-producing Enterobacteriaceae,\r\n             without signs and symptoms of active infection with ESBL-producing Enterobacteriaceae\r\n             at any body site\r\n\r\n          2. Patient must give written informed consent to participate in the study. The informed\r\n             consent can be given by the legal representative if necessary.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Women who are pregnant or nursing\r\n\r\n          2. Active infection\r\n\r\n          3. Treatment with antimicrobial agents with activity against ESBL-producing\r\n             Enterobacteriaceae\r\n\r\n          4. Contraindication to the use of one of the study drugs (e.g. renal insufficiency with\r\n             creatinine clearance < 30 ml/min)\r\n\r\n          5. Patient already enrolled in another study, or in the present study for a previous\r\n             episode\r\n\r\n          6. Psychiatric disorder or unable to understand or to follow the protocol directions\r\n\r\n          7. Permanent indwelling urinary catheter that can not be changed\r\n\r\n          8. Resistance of the ESBL-producing Enterobacteriaceae to one of the study drugs\r\n\r\n          9. Known hypersensitivity to one of the study drugs\r\n      ","sponsor":"University Hospital, Geneva","sponsor_type":"Other","conditions":"Enterobacteriaceae Infections","interventions":[{"intervention_type":"Drug","name":"Drug: Decolonization","description":"Colistin sulphate (50mg 4x/d PO) + Neomycin (250mg 4x/day PO) for 10 days\r\nplus In the presence of urinary tract colonization choice of one of the following agents (according to susceptibility profile, creatinine clearance and individual contraindications) Nitrofurantoin (100mg 3x/day PO) or Norfloxacin (400mg 2x/day PO) for 5 days"},{"intervention_type":"Drug","name":"Drug: Placebo (Decolonization)","description":"Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"Rate of eradication of carriage with ESBL-producing Enterobacteriaceae at day 28 post-treatment","time_frame":"28 days"}]}
{"nct_id":"NCT01137097","start_date":"2009-06-30","phase":"Phase 2/Phase 3","enrollment":278,"brief_title":"Lateral Neck Sentinel Lymph Node Biopsy(LSLNB)in PTC","official_title":"Value of Sentinel Lymph Node Biopsy to Lateral Neck Lymph Node in Thyroid Carcinoma: Prospective Study","primary_completion_date":"2011-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-01-31","last_update":"2016-04-21","description":"Objective: To investigate the incidence of lateral neck node occult metastasis and to show the usefulness of sentinel lymph node biopsy (SLNB) in the detection of lateral neck node metastasis in thyroid carcinoma, the investigators used a radioisotope to detect the sentinel lymph node. Summary Background Data: Although occult lymph node metastasis to the lateral neck compartment is common in papillary thyroid carcinoma, the incidence and patterns of lateral neck node metastasis in papillary carcinoma are not known.","other_id":"2009-07-101","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Cases with tumors larger than 1 cm in size or with suspicious central neck node\r\n             metastasis in Papillary thyroid cancer\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  The patient with definite metastatic lymph node in lateral neck compartment\r\n      ","sponsor":"Samsung Medical Center","sponsor_type":"Other","conditions":"Thyroid Neoplasm","interventions":[{"intervention_type":"Procedure","name":"Procedure: Lateral sentinel lymph node biopsy","description":"Sentinel lymph node biopsy with radioisotope. Isotope injection and lymphoscintigraphy preoperatively"}],"outcomes":[{"outcome_type":"primary","measure":"The usefulness of lateral sentinel lymph node biopsy in PTC","time_frame":"at Oct 2011"}]}
{"nct_id":"NCT00921999","start_date":"2009-06-15","enrollment":19,"brief_title":"Immune Response to Varicella-Zoster Vaccination and Infection","official_title":"Immune Responses to Varicella-Zoster Virus Vaccination and Infection","study_type":"Observational","rec_status":"Completed","completion_date":"2015-01-08","last_update":"2018-02-14","description":"Background: - The common varicella-zoster virus causes both chickenpox and shingles. Both diseases cause rashes, but they can also have complications such as bacterial infections of the skin, pneumonia, or eye disease. - By drawing and studying blood samples from people who have been infected with the varicella-zoster virus or who are receiving or have received the varicella vaccine, researchers hope to learn more about the immune system s response to the virus. Objectives: - To determine the immune system s response to the varicella virus, either in its existing form or given as part of a vaccine. Eligibility: - Individuals 18 years of age and older who have had or are receiving the varicella vaccine. - Individuals 5 years of age and older who currently have chickenpox or shingles. Design: - Participants will visit the NIH Clinical Center for an initial physical examination, and will provide blood samples for evaluation. - Researchers will determine the number of samples to be taken and the amount of blood to be drawn as needed based on the participants medical history and exposure to the varicella-zoster virus. Investigators in this study will not be giving subjects either the chickenpox or shingles vaccine. They will only be looking at the response to the vaccine in persons who are receiving or have received the vaccine from their health care provider.","other_id":"090170","time_perspective":"Prospective","sampling_method":"","gender":"All","minimum_age":5,"population":"","criteria":"\n        -  INCLUSION CRITERIA:\r\n\r\n        Group I Frequent Follow-up Group (N=110)\r\n\r\n          1. 18 years of age or older\r\n\r\n          2. Patients about to receive the varicella vaccine, or were vaccinated within the last 5\r\n             days (if stored blood is available).\r\n\r\n          3. Both males and females\r\n\r\n          4. Subjects must be able to sign the consent form and be willing to comply with study\r\n             procedures.\r\n\r\n          5. Subjects must be willing to have their blood samples stored.\r\n\r\n        Group II Infrequent Follow-up Group (N=30)\r\n\r\n          1. 18 years of age of older\r\n\r\n          2. Patient about to receive the varicella vaccine, or were vaccinated within the last 30\r\n             days (if stored blood is available).\r\n\r\n          3. Both males and females\r\n\r\n          4. Subjects must be able to sign the consent form and be willing to comply with study\r\n             procedures.\r\n\r\n          5. Subjects must be willing to have their blood samples stored.\r\n\r\n        Group III Vaccine Recipients-Vaccinated in the Past (N=60)\r\n\r\n          1. 18 years of age or older\r\n\r\n          2. Patients were vaccinated with varicella vaccine at least 6 months previously and must\r\n             provide written documentation of varicella vaccination\r\n\r\n          3. Both males and females\r\n\r\n          4. Subjects must be able to sign the consent form and be willing to comply with study\r\n             procedures.\r\n\r\n          5. Subjects must be willing to have their blood samples stored.\r\n\r\n        Group IV Patients with Varicella or Zoster (N=110)\r\n\r\n          1. 5 years or older<TAB>\r\n\r\n          2. Patients presenting with varicella or zoster.\r\n\r\n          3. Both males and females\r\n\r\n          4. Subjects and/or parents/guardians must be able to sign the consent or assent form and\r\n             be willing to comply with study procedures.\r\n\r\n          5. Subjects must be willing to have their blood samples stored.\r\n\r\n        EXCLUSION CRITERIA:\r\n\r\n        Study subjects will be excluded if they fulfill either of the following criteria:\r\n\r\n          1. Active substance abuse or history of prior substance abuse that may interfere with\r\n             protocol compliance or compromise patient safety (Groups I, II, IV who will be\r\n             providing several blood samples)\r\n\r\n          2. History of chickenpox, zoster, or having received the zoster vaccine for patients in\r\n             Groups I, II or III.\r\n\r\n          3. Patients in group I found to have a hemoglobin <11 gm/dl will be reassigned to group\r\n             II or terminated from the study.\r\n      ","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","sponsor_type":"NIH","conditions":"Chickenpox|Herpes Zoster","interventions":{},"outcomes":{}}
{"nct_id":"NCT00648115","start_date":"2009-06-01","phase":"N/A","enrollment":111,"brief_title":"Evaluating Vocational Materials for Incarcerated Veterans With Mental Illness or Substance Abuse","official_title":"Evaluating Vocational Materials for Incarcerated Veterans With Mental Illness","primary_completion_date":"2014-10-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-09-29","last_update":"2017-12-18","description":"The purpose of this research is to test the usefulness of a vocational rehabilitation program for veterans with a history of felonies who also have a mental illness or have substance dependency.","other_id":"D6192-R","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  underemployed or unemployed\r\n\r\n          -  has a mental health or substance dependence diagnosis\r\n\r\n          -  desires to enter the workforce through competitive employment.\r\n\r\n          -  History of at least one felony conviction\r\n\r\n        Emphasis will be placed on returning OEF/OIF veterans, combat veterans, and women veterans.\r\n        Veterans entering the study can be recruited regardless of living situation.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  pursuing disability benefits due to unemployability\r\n\r\n          -  diagnosis of dementia or evidence of severe cognitive impairment\r\n\r\n          -  impaired reality testing due to psychosis\r\n\r\n          -  actively suicidal or homicidal.\r\n      ","sponsor":"VA Office of Research and Development","sponsor_type":"U.S. Fed","conditions":"Mental Illness","interventions":[{"intervention_type":"Other","name":"Other: Basic Vocational Services","description":"Vocational services"},{"intervention_type":"Other","name":"Other: Self-Study","description":"Veteran receives self-study resources"},{"intervention_type":"Other","name":"Other: Group Program","description":"Veteran participates in group vocational program"}],"outcomes":[{"outcome_type":"primary","measure":"Time Till Employment in Days","time_frame":"12 months","description":"Number of days until first day of competitive employment"},{"outcome_type":"secondary","measure":"Test Economic Impact Between Manual Conditions (e.g., Cost-benefit Ratio)","time_frame":"12 months","description":"overall economic impact, in dollars, will be evaluated by the following formula: income - healthcare cost - cost of incarceration"}]}
{"nct_id":"NCT00890448","start_date":"2009-05-31","enrollment":66,"brief_title":"Case Control Study of Pharmacogenomic Factors Associated With Hepatocellular Injury Following Exposure to Lapaquistat Acetate","official_title":"A Modified Case Control Study to Identify Pharmacogenomic Factors Associated With Hepatocellular Injury Following Exposure to Lapaquistat Acetate","primary_completion_date":"2010-05-31","study_type":"Observational","rec_status":"Completed","completion_date":"2010-05-31","last_update":"2012-05-24","description":"The purpose of this study is to examine the genetic contribution to the mechanism of lapaquistat acetate- induced hepatic abnormalities.","other_id":"TAK-475_310","observational_model":"Case-Control","sampling_method":"Non-Probability Sample","gender":"All","population":"Subjects who participated in lapaquistat acetate phase 2 and phase 3 clinical studies","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Has experienced an alanine aminotransferase level greater than or equal to 5 times the\r\n             upper limit of normal, or concurrent elevation of alanine aminotransferase greater\r\n             than or equal to 3 times the upper limit of normal and bilirubin greater than or equal\r\n             to 2 times the upper limit of normal while participating in lapaquistat acetate\r\n             clinical studies.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  None\r\n      ","sponsor":"Takeda","sponsor_type":"Industry","conditions":"Toxicity","interventions":[{"intervention_type":"Other","name":"Other: Pharmacogenomic whole blood sampling","description":"10 mL, whole blood, one sample on Visit 2"}],"outcomes":[{"outcome_type":"primary","measure":"Candidate gene scanning using the Affymetrix Drug Metabolizing Enzymes and Transporter (DMET) array.","time_frame":"Visit 2"},{"outcome_type":"primary","measure":"Whole genome scanning using the Affymetrix 500K array chip.","time_frame":"Visit 2"},{"outcome_type":"primary","measure":"Whole genome scanning using the Illumina 1M chip.","time_frame":"Visit 2"}]}
{"nct_id":"NCT00902161","start_date":"2009-05-31","phase":"Phase 1","enrollment":22,"brief_title":"A Single-Dose Crossover Study of MK0893 in Patients With Type 2 Diabetes (0893-019 AM4)(COMPLETED)","official_title":"A Double-Blind, Randomized, Placebo-Controlled, Single-Dose Crossover Study to Assess the Safety and Tolerability of MK0893 Coadministered With Propranolol Hydrochloride in Patients With Type 2 Diabetes","primary_completion_date":"2009-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-11-30","last_update":"2015-07-03","description":"This study will assess the effect of combined treatment with MK0893 plus propranolol versus placebo plus propranolol on hypoglycemia.","other_id":"0893-019","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Participant has Type 2 Diabetes (T2DM)\r\n\r\n          -  Participant is either: Not on an oral antihyperglycemic medication for at least 6\r\n             weeks; on a single oral antihyperglycemic medication that is not a peroxisome\r\n             proliferator-activated gamma (PPAR-gamma) agonist (e.g. Avandia); OR on a combination\r\n             of no more than two antihyperglycemic medications that are not PPAR-gamma) agonists\r\n\r\n          -  Participant has not received insulin for at least 6 months\r\n\r\n          -  Participant has not been treated with a PPAR-gamma agonist for at least 12 weeks\r\n\r\n          -  Participant has been a nonsmoker for at least 6 months\r\n\r\n          -  Female participants who are non-pregnant and highly unlikely to conceive due to\r\n             surgical sterilization, post-menopausal status, not heterosexually active, or willing\r\n             to use 2 birth control methods\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Participant has a history of stroke, seizures, or neurological disorders\r\n\r\n          -  Participant cannot tolerate insulin or propranolol\r\n\r\n          -  Participant has a history of asthma, emphysema or chronic bronchitis\r\n\r\n          -  Participant is on a weight loss program that is not in the maintenance phase or has\r\n             been treated with a weight loss medication within 8 weeks of screening\r\n\r\n          -  Participant is on or may require treatment with drugs that affect the immune system or\r\n             with corticosteroids\r\n\r\n          -  Participant has a history of heart failure or coronary artery disease\r\n\r\n          -  Participant has a history of uncontrolled high blood pressure\r\n\r\n          -  Participant is Human Immunodeficiency (HIV), hepatitis B or hepatitis C positive\r\n\r\n          -  Participant has a history of Type 1 diabetes\r\n\r\n          -  Participant has a history of hypoglycemia unawareness documented by a blood glucose\r\n             concentration < 55 mg/dL (3.1 mol/L) without symptoms of hypoglycemia.\r\n      ","sponsor":"Merck Sharp & Dohme Corp.","sponsor_type":"Industry","conditions":"Type 2 Diabetes Mellitus","interventions":[{"intervention_type":"Drug","name":"Drug: MK0893","description":"Single dose of MK0893 1000 mg (ten 100 mg tablets)"},{"intervention_type":"Drug","name":"Drug: MK0893-matched Placebo","description":"Single dose of placebo to MK0893 (ten tablets)"},{"intervention_type":"Drug","name":"Drug: Propranolol Hydrochloride (HCL)","description":"Propranolol tablets titrated up to 80 mg three times daily over a four week period. Total treatment was approximately 7 weeks."}],"outcomes":[{"outcome_type":"primary","measure":"Recovery Time (Rt[65] From Insulin-induced Hypoglycemia","time_frame":"From the time of hypoglycemic clamp (t=0 minutes) through 270 minutes","description":"Rt(65) defined as the time to recover from hypoglycemia (blood glucose level of 50 mg/dL) to an arterialized venous blood glucose of 65 mg/dL. At t= -60 minutes on the morning of Day 1 (Visit 6) or Day 22 (Visit 8), a hypoglycemic clamp was used via an increased insulin infusion rate to achieve blood glucose concentrations of 50 mg/dL (2.8 mmol/L) within ~30-90 minutes. At the end of the 30-minute hypoglycemic clamp interval, insulin and glucose infusions were terminated, and the time to recover from hypoglycemia to 65 mg/dL Rt(65) was determined. Rt(65) was followed up to 270 minutes"},{"outcome_type":"secondary","measure":"Maximum Plasma Concentration (Cmax) and Concentration Average Over 8-12 Hours (C[Ave] 8-12 hr) Post Single Dose MK0893","time_frame":"From time of MK0893 administration through 24 hours post-dose","description":"Cmax was the maximum or \"peak\" concentration of MK0893 observed after its administration.\r\nApproximate C(ave 8-12) was the MK0893 concentration average over 8-12 hours post-dose and was computed as the Area Under the Curve over 8-12 hours post-dose (AUC [8-12]) ÷ 4"},{"outcome_type":"secondary","measure":"Plasma Concentration at 32 Hours (C[32hr]) Post Single Dose MK0893","time_frame":"From time of MK0893 administration through estimated 32 hours post-dose","description":"Plasma concentration of single dose MK0893 was measured from time of administration to 24 hours post-dose and extrapolated out to 32 hours post-dose using the plasma concentration vs. time curve"},{"outcome_type":"secondary","measure":"Number of Participants With An Adverse Event (AE)","time_frame":"From time of administration of study treatment through end of Post-Study (up to 21 days after administration of last dose of study treatment).","description":"An AE was defined as any unfavorable and unintended change in the\r\nstructure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. This also included any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product."},{"outcome_type":"secondary","measure":"Number of Participants Who Discontinued Study Treatment Due To AEs","time_frame":"From time of first administration of study treatment to time of last administration of study treatment (up to Day 21)","description":"An AE was defined as any unfavorable and unintended change in the\r\nstructure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. This also included any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product."}]}
{"nct_id":"NCT01127217","start_date":"2009-05-31","phase":"Phase 3","enrollment":149,"brief_title":"Efficacy/Safety of Amlodipine Plus Losartan Versus Amlodipine in Patients With Stage 2 Hypertension","official_title":"The Multicenter, Randomized, Double Blind Phase 3 Clinical Trial to Compare Efficacy and Safety of Combination of Amlodipine and Losartan Compared to Amlodipine Monotherapy in Patients With Stage 2 Hypertension","primary_completion_date":"2010-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-03-31","last_update":"2010-09-14","description":"The purpose of this study is to evaluate the blood pressure lowering effects of an amlodipine/losartan combination treatment and amlodipine monotherapy for treatment of Stage 2 hypertensive patients.","other_id":"HM-ALOS-303","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18 aged or over\r\n\r\n          -  Patients with blood pressure measured at Visit 1; MSSBP180mmHg and MSDBP110 mmHg if\r\n             on anti-hypertensive drugs, 160mmHgMSSBP199mmHg and 80mmHgMSDBP119mmHg if not on\r\n             anti-hypertensive drugs\r\n\r\n          -  Patients with blood pressure measured at Visit 2 were 160mmHgMSSBP199mmHg and\r\n             80mmHgMSDBP119mmHg\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Inability to stop all prior anti-hypertensive drugs safely during wash out period of 3\r\n             to 7 days\r\n\r\n          -   sitSBP 20mmHg or  sitDBP 10mmHg of variation in three measurements from the\r\n             reference arm selected at Screening\r\n\r\n          -  History of hypersensitivity to dihydropyridines, angiotensin II receptor blockers or\r\n             thiazide diuretics\r\n\r\n          -  Secondary hypertension or suspected to be\r\n\r\n          -  Continuously took medicinal drugs that might affect blood pressure rather than\r\n             anti-hypertensive drugs more than 3 months\r\n\r\n          -  Type 2 diabetes mellitus which is not controlled or with type 1 diabetes mellitus\r\n\r\n          -  History of severe neurovascular disease, severe heart disease\r\n\r\n          -  Known as moderate or malignant retinopathy.\r\n\r\n          -  Renal diseases; serum creatinine  2mg/dl\r\n\r\n          -  Hepatic diseases; increase in ALT or AST  2xUNL\r\n\r\n          -  Anuria\r\n\r\n          -  Hyponatremia/hypokalemia or hypercalcemia\r\n\r\n          -  Active Gout\r\n\r\n          -  Surgical or medical diseases which might significantly change ADME of medicines\r\n\r\n          -  History of malignant tumor\r\n\r\n          -  Autoimmune diseases\r\n\r\n          -  History of alcohol or drug abuse\r\n\r\n          -  Positive to pregnancy test, nursing mother, woman with an intention of pregnancy\r\n\r\n          -  Considered inappropriate to participate in the clinical trial with any reason, based\r\n             on investigator's decision\r\n\r\n        Other protocol-defined inclusion/exclusion criteria may apply\r\n      ","sponsor":"Hanmi Pharmaceutical Company Limited","sponsor_type":"Industry","conditions":"Hypertension","interventions":[{"intervention_type":"Drug","name":"Drug: amlodipine/losartan","description":"amlodipine 5mg/losartan 50mg, amlodipine 10mg/losartan 50mg (+HCTZ 12.5mg)"},{"intervention_type":"Drug","name":"Drug: amlodipine","description":"amlodipine 5mg, amlodipine 10mg (+ HCTZ 12.5mg)"}],"outcomes":[{"outcome_type":"primary","measure":"Change from baseline in MSSBP","time_frame":"Baseline, Week 6"},{"outcome_type":"secondary","measure":"Change from baseline in MSSBP","time_frame":"Baseline, Week 2 and 8"},{"outcome_type":"secondary","measure":"Change from baseline MSDBP","time_frame":"Baseline, Week 2, 6, and 8"},{"outcome_type":"secondary","measure":"Blood pressure responder rate","time_frame":"Baseline, Week 2, 6, 8","description":"Rate of patients who achieved target blood pressure (MSSBP < 140 mmHg or MSDBP < 90 mmHg), or MSSBP decrease > 20 mmHg from baseline or MSDBP decrease > 10 mmHg from baseline."}]}
{"nct_id":"NCT01515839","start_date":"2009-05-31","phase":"N/A","enrollment":100,"brief_title":"Single Photon Emission Computed Tomography (SPECT) Imaging Study of Professional American Football Players","official_title":"Brain Single Photon Emission Computed Tomography and Quantitative Electroencephalography In Former NFL Players: A Single-Site Exploratory Pilot Study","primary_completion_date":"2010-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-06-30","last_update":"2012-01-24","description":"The investigators primary objective is to acquire preliminary data on one-hundred former NFL veterans with at least one full year of professional service using brain SPECT imaging in order to assess the degree to which NFL football puts players at risk for traumatic brain injury (TBI). TBI severity shall be gauged via visual inspection by a clinician trained in neuroanatomy, and also by a statistical comparison of subjects' brains to an in-house proprietary database comprised of the brains of healthy subjects. The investigators secondary objective is to acquire additional data on these players such that investigators may establish causative factors and risks associated with said TBI. The investigators tertiary objective is to acquire data on subjects using various mental health metrics in order to determine the effects of TBI.","other_id":"ISCAN 001","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subjects must be at least 18 years of age\r\n\r\n          -  Each subject must have been on an active NFL roster for a minimum of one year\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any subjects who could not cease taking psychoactive medications (recreational or\r\n             otherwise) for an appropriate washout period prior to scanning were excluded from the\r\n             study\r\n      ","sponsor":"Amen Clinics, Inc.","sponsor_type":"Industry","conditions":"Traumatic Brain Injury","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Multivitamin Supplement intervention","description":"We recommend the following protocol:\r\n2 tablets of a high quality multivitamin BID\r\n2 capsules of omega 3 fish oil BID for a total of 3 grams daily\r\n3 capsules of a brain and memory formula BID which contains Acetyl-L-Carnitine (HCL) 1000 mg, Ginkgo Biloba Extract 120 mg, Alpha-Lipoic Acid (ALA) 300 mg, Huperzine A (Huperzia serrata)150 mcg, N-Acetyl-L-Cysteine (NAC) 600mg, Phosphatidyl Serine (soy) 100 mg, Vinpocetine 15mg\r\nWeight loss"}],"outcomes":[{"outcome_type":"primary","measure":"A concentration SPECT scan will be given to assess the changes in regional cerebral blood flow to the brain in our study participants.","time_frame":"The SPECT scan is one day imaging exam. A follow up scan will be performed following a 2-12 month supplement intervention.","description":"For the concentration study the subject will start the Conner's Continuous Performance Task, a 15-minute computer-administered test of attention, subsequent to the accommodation period. Three minutes into task performance 20 milliCuries of Tc-99m-hexamethylpropylene amine oxime will be injected through the catheter with attention to minimal disruption of the subject's attention task. The subject will proceed to completion of the attention task. The concentration scans will then be compared to a healthy brain subject normative database."},{"outcome_type":"secondary","measure":"Quantitative electroencephalography (QEEG) will be used to assess the damage to neural networks in our study participants.","time_frame":"The QEEG testing is one day exam. A follow up test will be performed following a 2-12 month supplement intervention.","description":"Subjects will undergo quantitative electroencephalography (QEEG) testing in both the eyes open and eyes closed condition to measure the electrical activity patterns of the brain. Brain maps will be generated and compared against a normative database."}]}
{"nct_id":"NCT00912041","start_date":"2009-05-31","phase":"N/A","enrollment":15,"brief_title":"BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia","official_title":"BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia","primary_completion_date":"2026-09-30","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2026-12-31","last_update":"2021-07-09","description":"The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with their thoughts.","other_id":"MGH-BG2-TP-001","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Other","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy,\r\n             amyotrophic lateral sclerosis or other motor neuron disorders\r\n\r\n          -  Complete or incomplete tetraplegia (quadriplegia)\r\n\r\n          -  Must live within a three-hour drive of the Study site\r\n\r\n          -  (There are additional inclusion criteria)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Visual impairment such that extended viewing of a computer monitor would be difficult\r\n             even with ordinary corrective lenses\r\n\r\n          -  Chronic oral or intravenous steroids or immunosuppressive therapy\r\n\r\n          -  Other serious disease or disorder that could seriously affect ability to participate\r\n             in the study\r\n\r\n          -  (There are additional exclusion criteria)\r\n      ","sponsor":"Leigh R. Hochberg, MD, PhD.","sponsor_type":"Other","conditions":"Tetraplegia|Spinal Cord Injuries|Amyotrophic Lateral Sclerosis|Brain Stem Infarctions|Locked in Syndrome|Muscular Dystrophy","interventions":[{"intervention_type":"Device","name":"Device: Placement of the BrainGate2 sensor(s) into the motor-related cortex","description":"Up to four 4x4 mm BrainGate2 sensor(s) are placed into the motor-related cortex, connected to a percutaneous pedestal. Neural recordings are made at least weekly for a year or more."}],"outcomes":[{"outcome_type":"primary","measure":"The primary endpoint of this Study is to determine the safety of the BrainGate2 Neural Interface System.","time_frame":"One year post-implant evaluation period"},{"outcome_type":"secondary","measure":"To investigate the feasibility of BrainGate2 and to establish the parameters for a larger clinical study, such as appropriate neural decoding algorithms, sample size, indices of measurement, success criteria, and endpoints.","time_frame":"Course of the study"}]}
{"nct_id":"NCT00875927","start_date":"2009-05-31","phase":"Phase 1/Phase 2","enrollment":75,"brief_title":"Effects of Breezy Candy on Halitosis","official_title":"Breezy Candy Halitosis Study","primary_completion_date":"2009-06-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2009-07-31","last_update":"2009-04-07","description":"Users of Breezy candy will utilize the candy's abrasiveness to scrape tongue surface. The scraping action together with the release of compounds contained inside the abrasive microcapsules will result in significant reduction of oral halitosis.","other_id":"BCHS","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  adult\r\n\r\n          -  healthy\r\n\r\n          -  male\r\n\r\n          -  female\r\n\r\n          -  bad breath\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  subject suffering from Diabetes\r\n\r\n          -  subject suffering from renal disease\r\n\r\n          -  pregnant women\r\n\r\n          -  cigarette smokers\r\n\r\n          -  any illness of oral cavity for the last 3 months\r\n\r\n          -  subjects undergoing chemotherapy\r\n\r\n          -  treatment by antibiotic\r\n\r\n          -  treatment by anti-inflammatory\r\n      ","sponsor":"Breezy Industries Ltd.","sponsor_type":"Industry","conditions":"Halitosis","interventions":[{"intervention_type":"Other","name":"Other: scraping microcapsules containing Propolis","description":"1, 4 grams, isomalt candy containing 2% Propolis scraping microcapsules"},{"intervention_type":"Other","name":"Other: scraping microcapsules containing and Zinc","description":"1, 4 grams, isomalt candy containing 2% Zinc scraping microcapsules"},{"intervention_type":"Other","name":"Other: scraping microcapsules containing Propolis and Zinc","description":"1, 4 grams, isomalt candy containing 2% Propolis and Zinc scraping microcapsules"},{"intervention_type":"Other","name":"Other: no scraping microcapsules","description":"1, 4 grams isomalt candy containing no scraping microcapsules"},{"intervention_type":"Other","name":"Other: scraping microcapsules containing inert TCP microcapsules","description":"1, 4 grams isomalt candy containing 2% inert TCP scraping microcapsules"}],"outcomes":[{"outcome_type":"primary","measure":"Users of Breezy Candy will have fresher breath over Control","time_frame":"150 minutes"}]}
{"nct_id":"NCT00903591","start_date":"2009-05-31","enrollment":1699,"brief_title":"Study of Radiation Exposure and Bilateral Breast Cancer","official_title":"Genome-Wide Association Study of Radiation Exposure and Bilateral Breast Cancer","primary_completion_date":"2022-05-31","study_type":"Observational","rec_status":"Active, not recruiting","completion_date":"2022-05-31","last_update":"2021-04-08","description":"This study is being done to find out what factors may be related to the risk of getting a second breast cancer among women who already have breast cancer in one breast. It will look at how genes, treatment for breast cancer; including radiation therapy, and the effects of different lifestyle activities, may affect the risk of breast cancer. It will use different processes to find genes that might increase the risk of breast cancer. The results of this study may help to develop better ways to detect, treat and prevent breast cancer. This study will compare women who have breast cancer in both breasts to women who have breast cancer in only one breast.","other_id":"09-040","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"Female","minimum_age":18,"maximum_age":54,"population":"All of the WECARE:GWA Study participants (new cases and individually matched controls) will\r\n        be identified, recruited, and interviewed by investigative teams in the five\r\n        population-based cancer registries (NCC, OCR, FHCRC, Iowa, and DCS).","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Eligibility for Cases: All women who meet the following eligibility requirements will\r\n             be recruited as cases for the WECARE:GWA Study if they are not already cases (or\r\n             refusers) from the parent WECARE Study:\r\n\r\n          -  Diagnosed since 1/1/1990 with a histologically confirmed first primary breast cancer\r\n             (only invasive stage 1 or 2) while residing in one of the study enrollment site\r\n             (cancer registry);\r\n\r\n          -  Diagnosed since 1/1/1992 with CBC (invasive only any stage) while residing in the same\r\n             enrollment site (cancer registry);\r\n\r\n          -  Two years or longer time interval between first and second primaries; Between the ages\r\n             of 18 and 54 at the time of diagnosis of the first primary;\r\n\r\n          -  Alive at time of contact; and\r\n\r\n          -  No history of previous or intervening cancer diagnosis, except cervical cancer in situ\r\n             (CIS) or non-melanoma skin cancer.\r\n\r\n          -  Without bilateral mastectomy or prophylactic mastectomy of the contralateral breast\r\n             following diagnosis of their first primary.\r\n\r\n        Eligibility for Controls: Women who meet all of the following requirements will be eligible\r\n        as controls. One matched control will be recruited for each participating case:\r\n\r\n          -  Diagnosed since 1/1/1990 with their first primary breast cancer (only invasive stage 1\r\n             or 2) while residing in one of the study enrollment site (i.e., cancer registry);\r\n\r\n          -  Between the ages of 18 and 54 at the time of diagnosis of the first primary;\r\n\r\n          -  Residing in the same study enrollment site (cancer registry) as when they were\r\n             diagnosed with their breast cancer;\r\n\r\n          -  Alive at time of contact;\r\n\r\n          -  Never diagnosed (at reference date (date of first diagnosis plus \"at risk interval\" of\r\n             matched case)) as having had CBC or any other cancer diagnosis other than the original\r\n             breast cancer; with the exception of CIS or non-melanoma skin cancer.\r\n\r\n          -  Without bilateral mastectomy or prophylactic mastectomy of the contralateral breast\r\n             following diagnosis of their first primary.\r\n\r\n        Matching of Controls: Controls eligible for inclusion in this study will be individually\r\n        matched (1:1) to cases on:\r\n\r\n          -  Enrollment site (cancer registry);\r\n\r\n          -  Age at diagnosis of the cases first primary(within 5-year age groups);\r\n\r\n          -  Year of diagnosis of the cases first primary;(within 4-year categories);\r\n\r\n          -  Race/ethnicity (white, black, Latina, Asian, other).\r\n\r\n        Exclusion Criteria:\r\n\r\n        Exclusion for Cases: Women with any of the following characteristics will be ineligible as\r\n        a case:\r\n\r\n          -  Unable to speak English in U.S. or Canadian enrolling sites or Spanish in the\r\n             California site, and Danish in Denmark\r\n\r\n          -  Unable to sign informed consent\r\n\r\n          -  Stage IV distant metastases for either the first or second primary (lymph node\r\n             metastasis is acceptable, but there should be no organ involvement\r\n\r\n          -  Simultaneous diagnosis of invasive in one breast and in situ in the other breast\r\n\r\n        Exclusion for Controls: Women with any of the following characteristics will be ineligible\r\n        as a control:\r\n\r\n          -  Unable to speak English in U.S. and Canadian enrolling sites, or Spanish in the\r\n             California site and Danish in Demark\r\n\r\n          -  Unable to sign informed consent\r\n\r\n          -  Stage IV distant metastases (lymph node metastasis is acceptable, but there should be\r\n             no organ involvement\r\n      ","sponsor":"Memorial Sloan Kettering Cancer Center","sponsor_type":"Other","conditions":"Breast Cancer","interventions":[{"intervention_type":"Other","name":"Other: questionaire, blood or saliva sample","description":"Take part in an approximately 45 minute telephone interview, with questions about detailed treatment (chemotherapy, hormonal therapy, radiation therapy (RT)) for all study participants. Their medical records will be reviewed to get further details about treatment of their breast cancer. They donate either a 35 ml blood sample (about 3 tablespoons) or a saliva sample. Blood Sample: if patient consents to give a blood sample, following the interview, they will be contacted by our staff phlebotomist (a person trained to draw blood). A scheduled appointment to draw a blood sample from you at your home. At the time of the blood draw, the phlebotomist will collect approximately 2 and 1/3 tablespoons of blood. Saliva Sample: if they choose not to give a blood sample, but consent to give a saliva sample instead, a saliva kit will be sent to there home. Once they provide the sample in the kit, they will be asked to mail back the sample in the pre-labeled kit that was sent to them."}],"outcomes":[{"outcome_type":"primary","measure":"Identify single nucleotide polymorphism's that are associated with contralateral breast cancer using a two-stage approach in a population-based case-control study.","time_frame":"2.5 years"},{"outcome_type":"secondary","measure":"Identify single nucleotide polymorphism that interact with radiation exposure.","time_frame":"2.5 years"},{"outcome_type":"secondary","measure":"Replication. Using the entire WECARE Study population, determine whether genomic regions found to be associated with unilateral breast cancer as identified via independent genome-wide association studies conducted by other research groups.","time_frame":"2.5 years"},{"outcome_type":"secondary","measure":"Characterize genomic regions containing variants associated with contralateral breast cancer and/or radiation-induced breast cancer in a population-based nested case-control study design.","time_frame":"2.5 years"}]}
{"nct_id":"NCT00917059","start_date":"2009-05-31","phase":"Phase 4","enrollment":172,"brief_title":"Personalized Indicators for Predicting Response to SSRI Treatment in Major Depression (The PRISE-MD Study)","official_title":"Personalized Response Indicators of SSRI Effectiveness in Major Depression","primary_completion_date":"2012-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-05-31","last_update":"2013-02-06","description":"This study will examine whether measures of brain electrical signals taken after a week of antidepressant medication treatment can predict whether a full treatment regimen will be effective.","other_id":"R01MH085925","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":21,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Meets DSM-IV criteria for diagnosis of major depressive disorder (MDD) based on the\r\n             Mini-International Neuropsychiatric Interview (MINI)\r\n\r\n          -  Score greater than or equal to 12 on the Quick Inventory of Depressive Symptomatology\r\n             - Self Rated version (QIDS-SR16)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Serious or unstable medical illness that would prevent complete participation in the\r\n             trial, determined as needed from physical examination, electrocardiogram (ECG),\r\n             laboratory safety tests, and review of systems\r\n\r\n          -  Mentally or legally incapacitated and therefore unable to give informed consent\r\n\r\n          -  Meets DSM-IV criteria for anorexia nervosa, bulimia nervosa, obsessive-compulsive\r\n             disorder, any cognitive disorder, bipolar disorder, psychotic disorder, or major\r\n             depression with psychotic features\r\n\r\n          -  Diagnosis of a DSM-IV axis II disorder that would interfere with completion of the\r\n             protocol\r\n\r\n          -  Would have met criteria for a diagnosis of drug dependency or substance abuse within\r\n             the preceding 9 months\r\n\r\n          -  Stable and in remission on current psychotropic medication(s)\r\n\r\n          -  Has had a course of electroconvulsive therapy (ECT) within the past 6 months\r\n\r\n          -  Started psychotherapy for the current depressive episode within the past 2 months\r\n\r\n          -  Has experienced treatment failure with an adequate trial of any study medication\r\n             during the current episode of depression or has failed to tolerate escitalopram in the\r\n             current episode\r\n\r\n          -  Known contraindication for use of any of the study drugs, including hyponatremia\r\n             during past use of a selective serotonin reuptake inhibitor (SSRI)\r\n\r\n          -  Treated with fluoxetine or a monoamine oxidase inhibitor (MAOI) within the past 4\r\n             weeks\r\n\r\n          -  Presence of a serious or unstable medical illness, including heart, liver, kidney,\r\n             respiratory, endocrine, neurologic, or blood disease severe enough to significantly\r\n             affect brain function or to interfere with interpretation of study results\r\n\r\n          -  History of seizures, brain surgery, skull fracture, significant head trauma, or\r\n             abnormal electroencephalogram (EEG)\r\n\r\n          -  Currently pregnant or of childbearing potential and not using a medically acceptable\r\n             means of birth control (e.g., oral contraceptive pill or implant, condom, diaphragm,\r\n             spermicide, intrauterine device [IUD], past tubal ligation, partner with vasectomy)\r\n\r\n          -  Breastfeeding\r\n\r\n          -  University student or staff member directly under instruction, supervision, or\r\n             employment of any of the investigators\r\n\r\n          -  Requires hospitalization (e.g., poses an imminent danger to self or others)\r\n\r\n          -  Initial quantitative EEG (QEEG) is contaminated with artifact so that determination of\r\n             the biomarker is precluded\r\n\r\n          -  Use of medications known to affect brain function\r\n      ","sponsor":"University of California, Los Angeles","sponsor_type":"Other","conditions":"Depression","interventions":[{"intervention_type":"Drug","name":"Drug: Escitalopram","description":"Fixed dose of 10 mg per day"},{"intervention_type":"Drug","name":"Drug: Bupropion XL","description":"Fixed dose of 150 mg per day"}],"outcomes":[{"outcome_type":"primary","measure":"Score on Hamilton Depression Rating Scale (HAM-D)","time_frame":"Measured nine times over 8 weeks"},{"outcome_type":"secondary","measure":"Score on Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30)","time_frame":"Measured nine times over 8 weeks"}]}
{"nct_id":"NCT00953797","start_date":"2009-05-31","phase":"N/A","enrollment":0,"brief_title":"Role of Enhanced External Counterpulsation (EECP) Therapy in Patients With Resistant Hypertension","official_title":"Role of EECP Therapy in Patients With Resistant Hypertension","primary_completion_date":"2011-10-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2011-10-31","last_update":"2012-01-26","description":"High Blood Pressure or Hypertension is one of the main causes of stroke, heart disease, heart attack and kidney disease. Traditionally physicians use diet and lifestyles change and medications to control patient's blood pressure. There are however, some patients whose blood pressures are difficult to control and their blood pressure remains elevated despite multiple medications. When blood pressure remains above goal (greater then 140/90 or greater then 130/80 mmHg in patients with diabetes or kidney disease) despite 3 or more blood pressure medications, the investigators call it \"Resistant Hypertension\". Enhanced External Counterpulsation (EECP) is a new method of treatment currently used in people with heart disease and chest pain. EECP therapy uses three sets of balloon like cuffs that are wrapped to the calves, lower thighs, and upper thighs. These cuffs inflate and deflate with every heart beat, causing increased blood return to the heart and better blood flow. It has also been found to improve the function of endothelial cells, a type of cells that lines the wall of blood vessel through out the body which helps to regulate and maintain blood pressure. This leads us to believe that EECP therapy, although not used at present for treating patients with Resistant Hypertension, may be useful in decreasing blood pressure.","other_id":"HN4112","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subjects who are competent to provide written consent\r\n\r\n          -  Aged 18 to 80 years\r\n\r\n          -  Deemed to be compliant with anti-hypertension medication therapy.\r\n\r\n          -  Subjects with diabetes and/or chronic kidney disease must have a mean systolic blood\r\n             pressure 130 mmHg\r\n\r\n          -  All other subjects must have a mean systolic blood pressure 140 mmHg\r\n\r\n          -  Receiving and adhering to full doses of appropriate guideline-recommended\r\n             antihypertensive drugs from three different classes of antihypertensive agents,\r\n             including a diuretic\r\n\r\n          -  Female subjects of non-childbearing potential (i.e., post-menopausal for at least 2\r\n             years; surgically sterile)\r\n\r\n          -  Deemed to be compliant with anti-hypertension medication therapy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Average sitting systolic blood pressure 180 mmHg or diastolic blood pressure 110\r\n             mmHg\r\n\r\n          -  Known Sleep apnea\r\n\r\n          -  Subjects who have participated in a clinical study involving another investigational\r\n             drug or device within 4 weeks prior to Screening\r\n\r\n          -  Have hypertension secondary to an identifiable and treatable cause other than sleep\r\n             apnea\r\n\r\n          -  Acute coronary syndrome < 6 weeks prior to enrollment\r\n\r\n          -  Non-bypassable left main coronary with a luminal stenosis  50%\r\n\r\n          -  CABG < 3 months or PCI < 6 months prior to enrollment\r\n\r\n          -  Cardiac catheterization < 2 weeks prior to enrollment\r\n\r\n          -  Arrhythmias that would significantly interfere with the triggering of the EECP device.\r\n\r\n          -  Clinically significant valvular heart disease\r\n\r\n          -  Acute myocarditis\r\n\r\n          -  ICD if it has been triggered < 3 months prior to enrollment\r\n\r\n          -  History of deep vein thrombosis, phlebitis, stasis ulcer, pulmonary embolism, and/or\r\n             aortic aneurysm\r\n\r\n          -  INR  2.5\r\n\r\n          -  Patients taking over the counter medications that can raise blood pressure, such as\r\n\r\n               -  Non narcotic analgesics\r\n\r\n               -  Non steroidal anti-inflammatory agents, including aspirin, Selective COX-2\r\n                  inhibitors\r\n\r\n               -  Sympathomimetic agents (decongestants, diet pills, cocaine)\r\n\r\n               -  Stimulants (methylphenidate, dexmethylphenidate, dextroamphetamine, amphetamine,\r\n                  methamphetamine, modafinil)\r\n\r\n               -  Alcohol\r\n\r\n               -  Oral contraceptives\r\n\r\n               -  Cyclosporine\r\n\r\n               -  Erythropoietin\r\n\r\n               -  Natural licorice\r\n\r\n               -  Herbal compounds (ephedra or ma huang)\r\n      ","sponsor":"Albert Einstein Healthcare Network","sponsor_type":"Other","conditions":"Hypertension","interventions":[{"intervention_type":"Device","name":"Device: Enhanced External Counterpulsation","description":"A non-invasive method currently used for the treatment of ischemic coronary disease. During EECP therapy three compressive pneumatic cuffs are wrapped around the calves, lower thighs, and upper thighs. The cuffs inflate sequentially during diastole causing retrograde aortic flow, and increased venous return. At end diastole, the cuffs rapidly deflate resulting in unloading of the left ventricle and a decrease in systolic blood pressure."}],"outcomes":[{"outcome_type":"primary","measure":"Change from baseline in mean ambulatory 24-hour systolic ambulatory blood pressure","time_frame":"Approximately 50 days"},{"outcome_type":"secondary","measure":"Change from baseline in mean ambulatory 24-hour diastolic ambulatory blood pressure","time_frame":"Approximately 50 days"}]}
{"nct_id":"NCT00821951","start_date":"2009-05-31","phase":"Phase 1","enrollment":17,"brief_title":"Vorinostat in Combination With Palliative Radiotherapy for Patients With Non-Small Cell Lung Cancer","official_title":"A Dose Escalation Study of Vorinostat in Combination With Palliative Radiotherapy for Patients With Non-Small Cell Lung Cancer","primary_completion_date":"2012-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-07-31","last_update":"2020-11-20","description":"This is a dose escalation study that will assess the safety of Vorinostat, a Histone Deacetylase (HDAC) inhibitor, in combination with palliative radiotherapy in patients with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC). Vorinostat has been approved for use in patients with cutaneous T-cell lymphomas, but several pre-clinical studies suggest activity in lung cancer cell lines. Several HDAC inhibitors,including Vorinostat, may enhance the effect of radiotherapy, and this study will seek to confirm this.","other_id":"0811004507","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Eligibility Criteria\r\n\r\n          -  Patients must have histologically or cytologically confirmed NSCLC. Patients must have\r\n             metastatic disease, stage IIIB with malignant pleural effusion, or be otherwise\r\n             unsuitable for potentially curative therapy due to bulk of disease or comorbid medical\r\n             illness. There must be disease apparent on imaging which offers a medical indication\r\n             for radiation therapy. Palliative radiotherapy would be offered as appropriate\r\n             standard therapy outside of a study setting. (NOTE: Radiotherapy utilized in this\r\n             regimen is the same as that which would be offered as standard treatment outside of\r\n             this study). Indications for palliative radiation include pain, pathologic fracture or\r\n             risk of fracture, lymphovascular obstruction, bronchial obstruction, neural\r\n             impingement, dyspnea, or bleeding.\r\n\r\n          -  There must be a measurable tumor target (visible, palpable, or radiographically\r\n             evident) for palliative radiation. The target for radiotherapy must be in the thoracic\r\n             region (i.e., there must be normal lung tissue at the same anatomic level).\r\n\r\n          -  Previous systemic therapy for NSCLC is allowed, as long as all prior therapy was\r\n             completed at least two weeks before enrollment. Patients treated with nitrosurea or\r\n             radioisotope may not be enrolled unless such treatment was at least 6 weeks prior to\r\n             enrollment. Patients must have no previous exposed to HDAC inhibitors (patients\r\n             previously treated with valproic acid are eligible if the exposure was greater than 30\r\n             days prior to enrollment).\r\n\r\n          -  Age 18 years. Because no dosing or adverse event data are currently available on the\r\n             use of vorinostat alone, or in combination radiation in patients <18 years of age,\r\n             children are excluded from this study.\r\n\r\n          -  ECOG performance status 3\r\n\r\n          -  Life expectancy of greater 3 months.\r\n\r\n          -  Patients must have normal organ and marrow function as defined below, all laboratory\r\n             values to be obtained within 2 weeks prior to enrollment:\r\n\r\n          -  absolute neutrophil count 1,500/mcL\r\n\r\n          -  platelets 100,000/mcL\r\n\r\n          -  hemoglobin 9 g/ dL\r\n\r\n          -  serum bilirubin <1.5 times the upper limit of normal (ULN) serum AST, ALT, ALP <2.5\r\n             times ULN\r\n\r\n          -  serum Creatinine <1.5 times ULN\r\n\r\n          -  serum Potassium, Magnesium, Calcium - within normal range\r\n\r\n          -  The effects of radiation on the developing human fetus are known to be teratogenic.\r\n             For this reason, women of child-bearing potential and sexually active men must agree\r\n             to use adequate contraception (hormonal or barrier method of birth control;\r\n             abstinence) prior to study entry and for the duration of study participation. Should a\r\n             woman become pregnant or suspect she is pregnant while participating in this study,\r\n             she should inform her treating physician immediately.\r\n\r\n          -  Ability to understand and the willingness to sign a written informed consent document.\r\n\r\n          -  Ability to swallow a capsule\r\n\r\n          -  Patients must have had a CT scan of the chest, abdomen, and pelvis (or PET/CT of the\r\n             body), as well as an MRI or contrasted CT of the brain within 30 days of enrollment\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with known, untreated brain metastases will be excluded from this clinical\r\n             trial because of their poor prognosis and because they often develop progressive\r\n             neurologic dysfunction that would confound the evaluation of neurologic and other\r\n             adverse events. Patients who have received whole brain radiotherapy within 2 weeks of\r\n             enrollment will also be excluded.\r\n\r\n          -  Patients treated on an investigational drug trial within 30 days of study enrollment.\r\n\r\n          -  Patients with active grade 2 or greater acute toxicity related to prior\r\n             cancer-directed therapy\r\n\r\n          -  History of allergic reactions attributed to compounds of similar chemical or biologic\r\n             composition to vorinostat, or patients with a history of an unanticipated severe\r\n             normal tissue reaction to previous radiation treatment.\r\n\r\n          -  Patients with congenital long QT-syndrome will be excluded, as a known side effect of\r\n             vorinostat is prolongation of QT interval. Patients on anti-arrhythmic medications or\r\n             other medications known to lead to prolonged QT interval will be exclude unless an ECG\r\n             has been obtained documenting a normal QT interval within 90 days prior to enrollment.\r\n\r\n          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active\r\n             infection (fever >38C within 48 hours of enrollment), symptomatic congestive heart\r\n             failure (i.e., NYHA class 3 or greater), unstable angina pectoris, coronary\r\n             angioplasty within 6 months prior to enrollment, or cardiac arrhythmia. Additionally,\r\n             patients with suspected or confirmed poor compliance, mental instability, or prior or\r\n             current alcohol or drug abuse deemed by the investigator to be likely to affect their\r\n             ability to sign the informed consent, or undergo study procedures will be excluded.\r\n\r\n          -  Pregnant women are excluded from this study because radiation has the potential for\r\n             teratogenic or abortifacient effects. Because there is an unknown but potential risk\r\n             for adverse events in nursing infants secondary to treatment of the mother with\r\n             vorinostat, breastfeeding should be discontinued if the mother is treated. Women of\r\n             childbearing potential must have a negative pregnancy test prior to enrollment.\r\n\r\n          -  Patients with active HIV or viral hepatitis.\r\n\r\n          -  Patients in whom primary radiation therapy, with potentially curative intent, is\r\n             indicated will be excluded.\r\n      ","sponsor":"Yale University","sponsor_type":"Other","conditions":"Non-Small Cell Lung Cancer (NSCLC)","interventions":[{"intervention_type":"Drug","name":"Drug: Vorinostat","description":"200 mg, 300 mg, 400 mg, once per RT fraction"},{"intervention_type":"Radiation","name":"Radiation: Radiotherapy","description":"Standard fractionation of 3.0 Gy per day over 2 weeks, to a total dose of 30 Gy, will be utilized for all patients. All patients will be treated one time per day, 5 days per week unless interruption is clinically indicated."}],"outcomes":[{"outcome_type":"primary","measure":"The Primary Endpoint of the Study is to Establish the Maximum Tolerated Dose of Vorinostat When Given Concurrently With Palliative Radiation.","time_frame":"1 Year","description":"maximum tolerated dose of vorinostat when given concurrently with radiation"},{"outcome_type":"secondary","measure":"Target Lesion Response","time_frame":"1 Year"},{"outcome_type":"secondary","measure":"Vorinostat Modification of the DNA Damage Response in Patient Samples","time_frame":"1 Year"}]}
{"nct_id":"NCT01181167","start_date":"2009-05-31","phase":"Phase 3","enrollment":610,"brief_title":"A Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty","official_title":"A Phase 3, Randomized, Double-Blind, Double-Dummy Efficacy and Safety Study of the Oral Factor Xa Inhibitor DU-176b Compared With Enoxaparin Sodium for Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty (STARS J-5 Trial)","primary_completion_date":"2010-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-03-31","last_update":"2019-03-05","description":"The objective of this study is to assess the efficacy and safety of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total hip arthroplasty.","other_id":"DU176b-B-J304","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":84,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients undergoing unilateral total hip arthroplasty\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subjects with risks of hemorrhage\r\n\r\n          -  Subjects with thromboembolic risks\r\n\r\n          -  Subjects who weigh less than 40 kg\r\n\r\n          -  Subjects who are pregnant or suspect pregnancy, or subjects who want to become\r\n             pregnant\r\n      ","sponsor":"Daiichi Sankyo Co., Ltd.","sponsor_type":"Industry","conditions":"Prevention|Venous Thromboembolism","interventions":[{"intervention_type":"Drug","name":"Drug: edoxaban"},{"intervention_type":"Drug","name":"Drug: enoxaparin sodium"}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of Subjects With Venous Thromboembolism Events","time_frame":"2 weeks","description":"The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment.\r\nLower extremity DVT confirmed by bilateral venography at the end of study treatment\r\nDefinite diagnosis of symptomatic PE\r\nSymptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of VTE"},{"outcome_type":"secondary","measure":"Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding","time_frame":"2 weeks"}]}
{"nct_id":"NCT00909792","start_date":"2009-05-31","phase":"N/A","enrollment":259,"brief_title":"Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products","official_title":"Clinical Evaluation of Two New Silicone Hydrogel Multifocal Products","primary_completion_date":"2009-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-06-30","last_update":"2012-06-29","description":"The objective of this trial is compare the visual performance, ratings, and preference of two multifocal, soft contact lenses.","other_id":"P-319-C-013","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":35,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Be at least 35 years of age\r\n\r\n          -  Best-corrected distance visual acuity of at least 20/40 in each eye.\r\n\r\n          -  Spectacle add between +0.75D and +1.50D (inclusive).\r\n\r\n          -  Able to be fit in available study sphere powers (-1.00 to -5.00D)\r\n\r\n          -  Currently wearing soft contact lenses at least 5 days a week.\r\n\r\n          -  Other protocol inclusion/exclusion criteria may apply.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Eye injury or surgery within twelve weeks immediately prior to enrollment.\r\n\r\n          -  Currently enrolled in an ophthalmic clinical trial.\r\n\r\n          -  Evidence of systemic or ocular abnormality, infection or disease likely to affect\r\n             successful wear of contact lenses or use of their accessory solutions.\r\n\r\n          -  Any use of medications for which contact lens wear could be contraindicated as\r\n             determined by the investigator.\r\n\r\n          -  Astigmatism  1.00D.\r\n\r\n          -  Currently wearing either of the study products.\r\n\r\n          -  Other protocol inclusion/exclusion criteria may apply.\r\n      ","sponsor":"CIBA VISION","sponsor_type":"Industry","conditions":"Presbyopia","interventions":[{"intervention_type":"Device","name":"Device: Lotrafilcon B","description":"Silicone hydrogel, soft, multifocal contact lens"},{"intervention_type":"Device","name":"Device: Senofilcon A","description":"Silicone hydrogel, soft, multifocal contact lens"}],"outcomes":[{"outcome_type":"primary","measure":"Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity","time_frame":"After 1 week of wear","description":"Tested while reading charts distant to the subject with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity."}]}
{"nct_id":"NCT00981838","start_date":"2009-04-30","phase":"Phase 3","enrollment":24,"brief_title":"Rituximab in Multirelapsing Minimal Change Disease (MCD) or Focal Segmental Glomerulosclerosis (FSGS)","official_title":"A Prospective, Sequential Study to Assess the Efficacy of Rituximab Therapy in Maintaining Remission of Nephrotic Syndrome After Steroid and Immunosuppressive Therapy Withdrawal in Patients With Steroid-dependant or Multirelapsing Minimal Change Disease or Focal Segmental Glomerulosclerosis (NEMO Study)","primary_completion_date":"2011-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-04-30","last_update":"2013-02-25","description":"Background. Patients, especially children, with steroid-dependent or multirelapsing nephrotic syndrome (NS) secondary to minimal change disease (MCD) or idiopathic focal and segmental glomerulosclerosis (FSGS) on continuous treatment with steroids and/or other immunosuppressive agents to limit or prevent recurrences are at increased risk of severe drug-related adverse events. Case reports suggest that Rituximab, a B cell depleting monoclonal antibody, could be a safe and effective alternative to steroid or immunosuppressants to achieve and maintain remission in this population. Objectives. The study is primarily aimed at evaluating whether Rituximab may maintain stable NS remission after tapering and withdrawal of steroid and immunosuppressive therapy in patients with MCD or FSGS and steroid-dependent or multirelapsing NS. Secondarily, the study will assess whether Rituximab allows reducing maintenance doses of steroids and other immunosuppressants (in those who relapse), thus limiting treatment related side effects and costs. Methods. This prospective, sequential, open, study will include 20 patients with histology evidence of MCD or FSGS and steroid-dependant or multirelapsing NS, who are on stable complete or partial remission since at least 1 month and, based on their previous history, are expected to invariably relapse after steroid/immunosuppression withdrawal. After baseline evaluation of clinical, laboratory and kidney function parameters [including glomerular filtration rate (GFR), renal plasma flow (RPF), albumin and sodium fractional clearance and the glomerular albumin permeability assay (Palb)], patients will receive one Rituximab infusion that will be repeated 1 week later if CD20 cells are not fully depleted from the circulation. Then ongoing immunosuppression will be progressively tapered up to complete withdrawal over 6 to 9 months. 24h proteinuria will be monitored monthly and spot urine will be tested daily by albustix to early detect disease relapses. Baseline evaluations will be repeated at study end (1 year). Relapses will be treated with high-dose steroids as per center practice and the last immunosuppressive therapy effective in preventing disease reactivation will be reintroduced. Expected results. Rituximab is expected to prevent NS recurrence following tapering and discontinuation of steroid and other immunosuppressants. Maintaining remission without chronic immunosuppression is expected to minimize risks and costs of therapy and to remarkably improve patient outcomes.","other_id":"NEMO","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":2,"maximum_age":80,"population":"","criteria":"\n        Inclusion criteria:\r\n\r\n          -  Males and females\r\n\r\n          -  Steroid-dependent or multirelapsing NS (defined on the basis of the occurrence of more\r\n             than 2 relapses in the previous year in spite of steroid and/or other\r\n             immunosuppressive therapy). Only patients reported to invariably relapse upon\r\n             treatment tapering or withdrawal who are on stable (from at least 1 month) complete\r\n             (<0.3 g/24h for adults or <4 mg/h/m2 for children) or partial (<3.5 g/24h for adults\r\n             or <40 mg/h/m2 for children) remission of the NS will be included;\r\n\r\n          -  Histological diagnosis of MCD or FSGS or mesangial proliferative GN;\r\n\r\n          -  Written informed consent (or consent from parents or tutors for underage patients).\r\n\r\n        Exclusion criteria:\r\n\r\n          -  Advanced renal failure (creatinine clearance less than 20 ml/min/1.73m2);\r\n\r\n          -  Evidence of B or C virus infection;\r\n\r\n          -  Refractory or persistent NS;\r\n\r\n          -  Genetic mutations associated with intrinsic abnormalities of the glomerular barrier\r\n             that would hardly be affected by rituximab treatment;\r\n\r\n          -  Pregnancy or lactating;\r\n\r\n          -  Women of childbearing potential without following a scientifically accepted form of\r\n             contraception;\r\n\r\n          -  Legal incapacity;\r\n\r\n          -  Evidence of an uncooperative attitude;\r\n\r\n          -  Previous diagnosis of: intellectual disability/mental retardation, dementia,\r\n             schizophrenia.\r\n\r\n          -  Any evidence that patient will not be able to complete the trial follow-up.\r\n      ","sponsor":"Mario Negri Institute for Pharmacological Research","sponsor_type":"Other","conditions":"Nephrotic Syndrome","interventions":[{"intervention_type":"Drug","name":"Drug: Rituximab","description":"Rituximab (375 mg/m2) will be given as a single intravenous infusion after reconstitution in normal saline to a concentration of 1 mg/ml given though a 0.22 micron in line filter. The initial infusion rate will be 1 ml/kg/h and will be progressively increased up to 4 ml/kg/h according to drug tolerability. Pre-medication with steroids and/or antihistaminic agents will be done according to per-center's practice.Rituximab administration will be repeated in those patients > 5 B cells/mm3 in the peripheral blood on the day after first Rituximab administration."}],"outcomes":[{"outcome_type":"primary","measure":"Recurrence of NS.","time_frame":"1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 month."},{"outcome_type":"secondary","measure":"The dose of immunosuppressive therapy to prevent further NS relapses. Adverse effects of immunosuppressive therapy, such as arterial hypertension and need for antihypertensive therapy, impaired glucose tolerance, dyslipidemia, renal dysfunction. Kidney","time_frame":"1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 month."}]}
{"nct_id":"NCT01732731","start_date":"2009-04-30","phase":"N/A","enrollment":12,"brief_title":"Effects of Intensive Locomotor Treadmill Training on Gross Motor Function in Young Children With Neuromotor Impairment","official_title":"Effects of Intensive Locomotor Treadmill Training on Gross Motor Function in Young Children With Neuromotor Impairment","primary_completion_date":"2012-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-09-30","last_update":"2012-11-26","description":"The purpose of this project is to examine if early exposure to intensive, short-term locomotor treadmill training (LT) in young children with neuromotor impairment will help develop walking skills earlier, decrease the amount of outside assistance needed (such as a walker or crutches) as compared to children with neuromotor impairment who receive traditional physical therapy intervention.","other_id":"09-97","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":0.75,"maximum_age":3,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  a diagnosis of CP with GMFCS levels I and II\r\n\r\n          -  ages 9 to 36 months\r\n\r\n          -  the ability to sit for at least 30 seconds unsupported in ring-sitting or W-sitting\r\n\r\n          -  the ability to take ten consecutive steps when held on hands\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  a diagnosis of a genetic syndrome\r\n\r\n          -  independent ambulation without an assistive device\r\n\r\n          -  previous or current use of treadmill intervention during physical therapy\r\n\r\n          -  a medical contraindication for standing or walking defined by the physician 5)\r\n             uncontrolled seizures\r\n\r\n          -  a history of orthopedic surgery\r\n\r\n          -  use of medication to control spasticity in the past 6 months\r\n      ","sponsor":"University of the Pacific","sponsor_type":"Other","conditions":"Cerebral Palsy","interventions":[{"intervention_type":"Other","name":"Other: treadmill training","description":"Home-based treadmill training will be administered to the children in the experimental group"}],"outcomes":[{"outcome_type":"primary","measure":"Gross Motor Function Measure Dimension D and E","time_frame":"up to 4-months post-intervention"},{"outcome_type":"secondary","measure":"Peabody Developmental Motor Scales-2","time_frame":"pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention"},{"outcome_type":"secondary","measure":"timed 10 meter walk test","time_frame":"pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention"},{"outcome_type":"secondary","measure":"Pediatric Evaluation of Disability Inventory","time_frame":"pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention"}]}
{"nct_id":"NCT00870220","start_date":"2009-04-30","phase":"Phase 1","enrollment":1,"brief_title":"Initiating Transdermal Estradiol Therapy in Turner's Syndrome","official_title":"Initiating Transdermal Estradiol Therapy in Turner's Syndrome","primary_completion_date":"2011-03-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2011-03-31","last_update":"2014-03-11","description":"This is a multicenter, randomized, controlled, semi-blinded study to compare two low doses of estradiol administered by recently available transdermal patches for the initiation of puberty in Turner syndrome girls 11.5-13.0 years old in conjunction with growth hormone (GH) therapy. The specific hypotheses to be tested are: when combined with growth hormone (GH) treatment, low dose transdermal estradiol (LTE2) replacement will be more effective in stimulating feminization, height velocity, and bone mineral density without compromising growth potential than very low dose transdermal estradiol (VLTE2), which will in turn be superior to GH alone in effects on feminization, height velocity, and bone mineral density.","other_id":"15327B","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"Female","minimum_age":11.5,"maximum_age":13,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  60 subjects will be recruited from participating Pediatric Endocrinology Clinics in\r\n             the United States.\r\n\r\n          -  Subjects will be 11.5-13.0 years of age and must have completed at least 6 months of\r\n             GH therapy prior to the study.\r\n\r\n          -  Subjects may not have had any estrogen prior to the study. All subjects must be breast\r\n             stage 1 and euthyroid prior to the study\r\n\r\n          -  Those on thyroid medication will continue the appropriate thyroid replacement therapy\r\n             during the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  On estrogen therapy, breast stage 2 or greater, not on GH for at least 6 months.\r\n      ","sponsor":"University of Chicago","sponsor_type":"Other","conditions":"Turner's Syndrome","interventions":[{"intervention_type":"Drug","name":"Drug: Norditropin, Menostar 14mcg patch, Vivelle dot 25mcg patch","description":"GH will be maintained at 0.05mg/kg/d, adjusted every 3 months. Estradiol 14mcg patch will be applied for 10 days/month for the first 6 months in Group 2. Estradiol 25mcg patch will be applied for 10 days/month for the second 6 months in Group 2, and for the first 6 months in Group 3. Estradiol 25mcg patch will be applied for 3 weeks per month for the second 6 months in Group 3."}],"outcomes":[{"outcome_type":"primary","measure":"The net change of height velocity between Group 2 and Group 3 and the net change in predicted height between Group 2 and Group 3.","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Plasma E2 level to document the dose-response effect of the applied prescription and uterine dimensions to quantitate the estrogenic effect on growth and development of the uterus.","time_frame":"12 months"}]}
{"nct_id":"NCT00919087","start_date":"2009-04-30","enrollment":25,"brief_title":"Non Invasive Arrhythmia Detection in Hospital Settings","official_title":"Evaluating Ventricular Events With Adherent Patient Monitoring Study","primary_completion_date":"2009-08-31","study_type":"Observational","rec_status":"Completed","completion_date":"2009-08-31","last_update":"2010-02-04","description":"This is a prospective, single center, non-randomized study to evaluate the arrhythmia detection performance during ventricular events.","other_id":"COR-2009-002","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"electrophysiology (EP) study or implantable cardioverter defibrillator (ICD) implant\r\n        Patients","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Is female or male, 18 years of age or older\r\n\r\n          -  Undergoing ICD implant with ventricular arrhythmia induction OR undergoing EP study\r\n             with ventricular arrhythmia induction\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Is participating in another clinical study that may confound the results of this study\r\n      ","sponsor":"Corventis, Inc.","sponsor_type":"Industry","conditions":"Arrhythmias","interventions":[{"intervention_type":"Device","name":"Device: Avivo System","description":"Non invasive external monitoring deive"}],"outcomes":{}}
{"nct_id":"NCT02135965","start_date":"2009-04-30","phase":"Early Phase 1","enrollment":8,"brief_title":"Testing Potential Synergistic Effects of Albuterol and Caffeine on Metabolic Rate","official_title":"Testing Potential Synergistic Effects of Albuterol and Caffeine on Metabolic Rate.","primary_completion_date":"2011-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-08-31","last_update":"2015-12-18","description":"The purpose of this study is to define a ratio of Caffeine and albuterol that gives a synergistic increase in metabolic rate.","other_id":"PBRC 28026","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Basic Science","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy male or female between the ages of 18 to 50 years, inclusive.\r\n\r\n          -  Have a body mass index between 19 and 40 kg/M2 ( a number calculated from your height\r\n             and weight), inclusive.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Female who is pregnant or nursing.\r\n\r\n          -  Woman of childbearing potential and do not agree to use an effective method of\r\n             contraception during the trial. Acceptable methods include abstinence, barrier\r\n             methods, intrauterine devices, and hormonal methods of contraception.\r\n\r\n          -  A smoker or use nicotine.\r\n\r\n          -  Take regular medication other than birth control pills.\r\n\r\n          -  Use medications known to alter metabolic rate (some asthma medications).\r\n      ","sponsor":"Pennington Biomedical Research Center","sponsor_type":"Other","conditions":"Healthy Volunteers","interventions":[{"intervention_type":"Drug","name":"Drug: 2mg of Albuterol","description":"2mg of Albuterol on metabolic rate"},{"intervention_type":"Drug","name":"Drug: 4mg of Albuterol","description":"4mg of Albuterol on metabolic rate"},{"intervention_type":"Drug","name":"Drug: 100mg of Caffeine","description":"100mg of caffeine on metabolic rate"},{"intervention_type":"Drug","name":"Drug: 200mg of Caffeine","description":"200mg of Caffeine on metabolic rate"},{"intervention_type":"Drug","name":"Drug: Albuterol 2mg & Caffeine 100mg","description":"Albuterol 2mg and 100mg of Caffeine"},{"intervention_type":"Drug","name":"Drug: Albuterol 2mg and Caffeine 200mg","description":"Albuterol 2mg and Caffeine 200mg on metabolic rate"},{"intervention_type":"Drug","name":"Drug: Albuterol 4mg and Caffeine 100mg","description":"Albuterol 4mg and Caffeine 100mg on metabolic rate"},{"intervention_type":"Drug","name":"Drug: Albuterol 4mg and Caffeine 200mg","description":"Albuterol 4mg and Caffeine 200mg on metabolic rate"}],"outcomes":[{"outcome_type":"primary","measure":"A change is being assessed for the combination of Albuterol and Caffeine on Metabolic rate.","time_frame":"Participants will be followed at Baseline and the duration of the study, an expected average of 10 weeks.","description":"The order of which 8 combinations will be determined randomly (like flipping a coin) and neither the participant nor the study personnel will know what is in the pills. The identity of the pills can be determined by breaking the code in the case of an emergency. 1. Albuterol 2mg; 2. Albuterol 4mg; 3. Caffeine 100mg; 4. Caffeine 200mg; 5. Albuterol 2mg and Caffeine 100mg; 6. Albuterol 2mg and Caffeine 200mg; 7. Albuterol 4mg and Caffeine 100mg; 8. Albuterol 4mg and Caffeine 200mg. The data will be analyzed by computing the metabolic rate. Metabolic rate is measured by breathing with a clear plastic hood over the upper body to measure the oxygen inhaled and the carbon dioxide exhaled."},{"outcome_type":"secondary","measure":"Respiratory Quotient (RQ)","time_frame":"Participants will be followed at Baseline and the duration of the study, an expected average of 10 weeks.","description":"The respiratory quotient (RQ) is calculated from a ratio indicating the relation of the volume of carbon dioxide given off in respiration to that of the oxygen consumed."},{"outcome_type":"secondary","measure":"Pulse rate","time_frame":"Participants will be followed at Baseline and the duration of the study, an expected average of 10 weeks.","description":"Pulse is the rate at which the heart beats. The pulse is usually called heart rate, which is the number of times the heart beats each minute."},{"outcome_type":"secondary","measure":"Blood Pressure","time_frame":"Baseline to 8 time points of dose","description":"When the heart beats, it contracts and pushes blood through the arteries to the rest of your body. This force creates pressure on the arteries. This is called systolic blood pressure or the top number. A systolic blood pressure or the bottom number indicates the pressure in the arteries when the heart rests between beats."},{"outcome_type":"secondary","measure":"Temperature","time_frame":"Participants will be followed at Baseline and the duration of the study, an expected average of 10 weeks.","description":"An oral temperature is when the thermometer is placed in the mouth to measure the body heat."},{"outcome_type":"secondary","measure":"Safety Assessments (lab, adverse events, physical exams and electrocardiograms)","time_frame":"Participants will be followed at Baseline and the duration of the study, an expected average of 10 weeks.","description":"Labs, adverse events, physical exams and electrocardiograms (ECG or EKG) are assessed to make sure nothing is out of normal range."}]}
{"nct_id":"NCT01502787","start_date":"2009-04-30","phase":"Phase 4","enrollment":46,"brief_title":"Comparison of Nebivolol and Metoprolol With Exercise and Angiotensin II in Hypertensive Patients","official_title":"Effects of Nebivolol Versus Metoprolol on Blood Flow Responses to Exercise and Angiotensin II in Hypertensive Patients","primary_completion_date":"2013-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-06-30","last_update":"2020-07-07","description":"The purpose of this study is to determine if Nebivolol a) attenuates the angiotensin II (Ang II)-induced increase in oxidative stress, thereby attenuating Ang II-induced vasoconstriction; and b) attenuates sympathetic mediated vasoconstriction during exercise, thereby reducing functional skeletal muscle ischemia in hypertensive patients.","other_id":"STU 062011-072","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Stage I hypertension (140-159/90-99 mmHg)\r\n\r\n          -  Men and women age 18-65\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Congestive heart failure or coronary artery disease\r\n\r\n          -  Blood pressure averaging >159/99 mmHg or resting heart rate < 55 bpm\r\n\r\n          -  Serum creatinine > 1.4 mg/dL\r\n\r\n          -  Asthma or chronic obstructive pulmonary diseases\r\n\r\n          -  Left ventricular hypertrophy by echocardiography or ECG\r\n\r\n          -  Pregnancy\r\n\r\n          -  Hypersensitivity to beta blockers, microbubble contrast agents, or angiotensin\r\n\r\n          -  Any history of substance abuse (other than tobacco)\r\n\r\n          -  Concomitant drug treatment which raises endogenous nitric oxide levels such as\r\n             nitrates or phosphodiesterase V inhibitors (Viagra, Levitra, or Cialis)\r\n\r\n          -  History of symptomatic bradycardia or heart block\r\n      ","sponsor":"University of Texas Southwestern Medical Center","sponsor_type":"Other","conditions":"Hypertension","interventions":[{"intervention_type":"Procedure","name":"Procedure: Forearm blood flow","description":"Using high-resolution ultrasound, investigators will measure skeletal muscle blood flow in the forearm at rest, following handgrip exercise (described below), and following Angiotensin II infusion (described below)."},{"intervention_type":"Drug","name":"Drug: Metoprolol succinate","description":"The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued."},{"intervention_type":"Drug","name":"Drug: Nebivolol","description":"The subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued."},{"intervention_type":"Procedure","name":"Procedure: Microneurography","description":"Investigators will measure sympathetic nerve activity from the peroneal nerve by inserting a tiny needle directly into the nerve in the leg. Investigators will localize the nerve by electrical stimulation over the skin using a blunt probe. With this stimulation, subject will notice either involuntary twitching or a tingling sensation, which may be annoying but not painful. Investigators will then introduce a tiny, sterile wire needle (an electrode) through the skin at the same location. When the tip of the needle enters the nerve, subjects may again notice involuntary muscle twitches or tingling in the leg. Investigators will then turn the electrical stimulator off and make minor adjustments in the position of the needle until investigators begin to record the nerve signals. The recording needle will remain in position throughout the study."},{"intervention_type":"Procedure","name":"Procedure: Rhythmic handgrip exercise","description":"Subjects will perform a rhythmic handgrip exercise at 30% of maximal voluntary contraction for 3 minutes. Investigators will measure cardiac output (non-invasive impedance plethysmography), blood pressure, and sympathetic nerve activity (SNA) at baseline and following this handgrip exercise."},{"intervention_type":"Procedure","name":"Procedure: Lower body negative pressure","description":"Lower body negative pressure increases sympathetic nerve activity. Therefore, investigators will measure cardiac output (non-invasive impedance plethysmography), blood pressure and sympathetic nerve activity at baseline and after rhythmic handgrip exercise plus lower body negative pressure (LBNP) for 2 minutes."},{"intervention_type":"Drug","name":"Drug: Angiotensin II","description":"Investigators will measure cardiac output (non-invasive impedance plethysmography), blood pressure and sympathetic nerve activity at baseline and during intravenous infusion of Angiotensin II at the dose of 1, 2, and 3 ng/kg/min for 15 minutes at each dose."}],"outcomes":[{"outcome_type":"primary","measure":"Forearm Blood Flow","time_frame":"12 weeks after each specified medication"},{"outcome_type":"secondary","measure":"Blood Pressure During Exercise","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"Blood Pressure During Angiotensin II Infusion","time_frame":"12 weeks after initiation of metoprolol"}]}
{"nct_id":"NCT01964755","start_date":"2009-04-21","phase":"Phase 2","enrollment":6,"brief_title":"Chemotherapy for Relapsed Epstein Barr Virus Associated Lymphoma","official_title":"Phase II Study of Chemotherapy (Doxorubicin, Methotrexate and Leucovorin) in Combination With Antiviral-Based Therapy (Zidovudine + Hydroxyurea) for AIDS, Immunocompromised, or Immunocompetent Patients With Relapsed or CNS Positive Epstein Barr Virus Associated Lymphoma","primary_completion_date":"2018-06-07","study_type":"Interventional","rec_status":"Terminated","completion_date":"2018-06-07","last_update":"2019-09-23","description":"By combining a variety of agents that potentiate Zidovudine (ZDV), the investigators hope to induce remission in this generally fatal disease. Most therapies for aggressive B cell lymphomas are based upon intensive chemotherapeutic regimens, expensive modalities (bone marrow transplant, Rituximab), or experimental approaches (gene therapy, cytotoxic T cell infusion) that are difficult to implement in heavily pre-treated patients. Therapy for relapsed aggressive B cell lymphomas is very poor. Even curable lymphomas such as Burkitt Lymphoma (BL) and Hodgkin lymphoma are extremely difficult to treat in relapse and/or after stem cell transplant failure. The investigators propose a novel therapeutic approach that exploits the presence of Epstein-Barr virus (EBV) in lymphomas; antiviral mediated suppression of NF-kB and disruption of viral latency.","other_id":"20090166","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Any stage, histologically or cytologically documented intermediate to high grade\r\n             relapsed or refractory EBV+ non-Hodgkin's (NHL) or Hodgkin's lymphoma (HL), or any\r\n             treated or untreated patients with EBV+ lymphoma involving CNS. Patients with relapsed\r\n             or refractory monomorphic (monoclonal) post-transplant lymphoproliferative disease\r\n             (PTLD) are also eligible.\r\n\r\n          2. Patients who are HIV+ or negative. Documentation of HIV infection can be done at any\r\n             time prior to study entry. Documentation may be serologic (positive ELISA and positive\r\n             Western blot), molecular (positive HIV viral RNA), or other federally approved\r\n             licensed HIV test. Prior documentation of HIV seropositivity is acceptable.\r\n\r\n          3. Tumors must be positive for EBV. This may be done either by Epstein-Barr virus-encoded\r\n             small RNA (EBER) stain on the original tumor or the biopsy of relapsed disease (if\r\n             performed). Biopsy of relapsed disease is desirable but not mandatory. If stains for\r\n             Epstein-Barr virus latent membrane protein 1 (LMP1) done outside are positive, EBER\r\n             does not need to be done.\r\n\r\n          4. All patients, except those who have CNS involvement, must have relapsed or progressed\r\n             from at least one previous chemotherapy based regimen.\r\n\r\n          5. Measurable or non-measurable tumor parameter(s). Non-measurable tumor parameter(s) is\r\n             defined as not having bi-dimensional measurements (e.g., gastric or marrow\r\n             involvement), but can be followed for response by other diagnostic tests such as\r\n             gallium scan, Positron emission tomography (PET) imaging and/or bone marrow biopsy.\r\n\r\n          6. Age  18 years.\r\n\r\n          7. Karnofsky performance status (KPS)  50%/Eastern Cooperative Oncology Group (ECOG)\r\n             Performance Score 0, 1, 2.\r\n\r\n          8. Patients must have adequate end organ and bone marrow function as defined below:\r\n\r\n               -  8.1 Absolute neutrophil count  1,500 cells/mm3 and platelets  75,000 cells/dL\r\n                  unless cytopenias are secondary to lymphomatous involvement of bone marrow or due\r\n                  to HIV-related thrombocytopenia. All patients must be off colony stimulating\r\n                  factor therapy at least 24 hours prior to institution of Cycle 1 chemotherapy.\r\n\r\n               -  8.2 Adequate hepatic function: Serum glutamic-oxaloacetic transaminase (SGOT)  5\r\n                  times the upper limit of normal. Total bilirubin  2.0 mg/dL (unless elevated\r\n                  secondary to lymphomatous involvement of liver or biliary system or due to other\r\n                  HIV medications [e.g., indinavir, tenofovir or atazanavir]). Patients who are\r\n                  negative for Hepatitis B, or if infected with Hepatitis B, receiving\r\n                  anti-Hepatitis B therapy are eligible. All subjects will be required to be\r\n                  screened for Hepatitis B and C. Per Infectious Diseases Society of America (IDSA)\r\n                  and American Association for the Study of Liver Diseases (AASD) guidelines, those\r\n                  subjects that show no immunity, defined by the lack of Hepatitis B surface\r\n                  antibody, and show evidence of chronic infection (i.e. HBsAg+, HBcore+, HBsAB-)\r\n                  will be required to be on anti-Hepatitis B therapy, during the study, in order to\r\n                  be eligible. Patients will be permitted to enroll in the study provided liver\r\n                  function tests meet criteria listed above, and there is no evidence of cirrhosis.\r\n                  The exact Hepatitis B therapy will be at the discretion of the infection disease\r\n                  specialist or investigator. However all patients who present with acute hepatitis\r\n                  B or show normal transaminases and are HBsAg+ and IgM+ for Hepatitis core antigen\r\n                  will not be eligible for trial enrollment. Subjects who are Hepatitis C antibody\r\n                  positive, with or without a positive Hepatitis C RNA level, will be permitted to\r\n                  enroll in the study provided liver function tests meet criteria listed above, and\r\n                  have no evidence of cirrhosis. Patients diagnosed with Hepatitis C less than 6\r\n                  months from trial enrollment, will be considered to have Acute Hepatitis C and\r\n                  will be excluded from study unless Hep C viral load is undetectable.\r\n\r\n               -  8.3 Creatinine  2.0 mg/dL or creatinine clearance  60 mL/min unless due to\r\n                  renal involvement by lymphoma.\r\n\r\n          9. Concurrent radiation, with or without steroids, for emergency conditions secondary to\r\n             lymphoma (CNS tumor, cord compression, etc.) will be permitted.\r\n\r\n         10. Females with childbearing potential must have a negative serum pregnancy test within 7\r\n             days prior of entering into the study. Men and women must agree to use adequate birth\r\n             control if conception is possible during the study. Women must avoid pregnancy and men\r\n             avoid fathering children while in the study and for 6 months following the last study\r\n             drug treatment.\r\n\r\n         11. Able to give consent.\r\n\r\n         12. Patients already receiving erythropoietin or Granulocyte-colony stimulating factor\r\n             (G-CSF) are eligible, although G-CSF therapy must be discontinued at least 24 hours\r\n             prior to receiving chemotherapy.\r\n\r\n         13. The maximum cumulative dose of doxorubicin allowed is 450 mg/m2. Patients who have\r\n             previously received doxorubicin with a cumulative dose of 350 mg/m2 or greater are\r\n             eligible but MAY NOT receive doxorubicin under protocol.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Concurrent active malignancies, with the exception of in situ carcinoma of the cervix,\r\n             non-metastatic, non-melanomatous skin cancer, or Kaposi sarcoma not requiring systemic\r\n             chemotherapy.\r\n\r\n          2. Myocardial infarction (MI) within 6 months prior to study entry, New York Heart\r\n             Association (NYHA) Class II or greater heart failure, uncontrolled angina, severe,\r\n             uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or\r\n             electrocardiograph evidence of acute ischemic or active conduction system\r\n             abnormalities.\r\n\r\n          3. Left Ventricular Ejection Fraction (LVEF) that is less than the lower institutional\r\n             limits of normal as assessed by Multiple Gated Acquisition (MUGA) scan or\r\n             echocardiogram within 6 weeks prior to registration.\r\n\r\n          4. Subjects with viral hepatitis who do not meet the criteria listed on (8.2) will be not\r\n             be eligible. All patients who present with acute hepatitis B including those with\r\n             normal transaminases who are HBsAg+ and IgM + for hepatitis core antigen will not be\r\n             eligible. Subjects who are Hepatitis B core antibody positive are eligible only if\r\n             they start or are on prophylactic therapy. A hepatitis B viral load should be\r\n             confirmed negative on all patients who are hepatitis B core antibody positive, but\r\n             hepatitis B antigen negative. Patients refusing to take any anti-hepatitis B therapy\r\n             during study will also be excluded. Patients diagnosed with Hepatitis C are eligible\r\n             if they meet criteria listed on (8.2).\r\n\r\n          5. Psychological, familial, sociological or geographical conditions that do not permit\r\n             treatment and/or medical follow-up required to comply with the study protocol.\r\n\r\n          6. Patients may not be receiving any other investigational agents.\r\n\r\n          7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active\r\n             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac\r\n             arrhythmia, or psychiatric illness/social situations that would limit compliance with\r\n             study requirements. Patients with mycobacterium avium will not be excluded.\r\n\r\n          8. Pregnant or breast-feeding women.\r\n      ","sponsor":"University of Miami","sponsor_type":"Other","conditions":"Epstein Barr Virus Associated Non Hodgkin's Lymphoma|Epstein Barr Virus Associated Hodgkin's Lymphoma|Post-Transplant Lymphoproliferative Disease","interventions":[{"intervention_type":"Drug","name":"Drug: Doxorubicin","description":"Doxorubicin 20 mg/m2 intravenously will be administered on Day 1 in patients with systemic (non-primary CNS) lymphoma as per institutional guidelines"},{"intervention_type":"Drug","name":"Drug: Methotrexate","description":"Methotrexate administered starting on Day 2, per study protocol."},{"intervention_type":"Drug","name":"Drug: Leucovorin","description":"Leucovorin administered first intravenously 24 hours after start of Methotrexate infusion, then orally every 6 hours for at least 10 doses, per study protocol."},{"intervention_type":"Biological","name":"Biological: Hydroxyurea","description":"Hydroxyurea administered orally twice daily starting on Day 2, and continuing for a total of 10 doses, per study protocol"},{"intervention_type":"Drug","name":"Drug: Zidovudine","description":"Zidovudine administered first intravenously on Day 2, and then orally twice daily for 10 doses, per study protocol."},{"intervention_type":"Drug","name":"Drug: Rituximab","description":"Rituximab is optional and will be administered to study participants, per study protocol."}],"outcomes":[{"outcome_type":"primary","measure":"Rate of Complete Response to Protocol Therapy","time_frame":"About 21 days","description":"Complete Response (CR) rate in study participants to protocol therapy. Response will be assessed via CT Scan and bone marrow aspirate/biopsy, if applicable. Complete response criteria include:\r\nComplete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities definitely assignable to Non Hodgkin's Lymphoma (NHL);\r\nAll lymph nodes and tumor masses disappeared or regressed to normal size (≤ 1.5 cm in their greatest transverse diameters for nodes > 1.5 cm before therapy);\r\nPreviously involved nodes that were 1.1 to 1.5 cm in their greatest transverse diameter (GTD) before treatment must have decreased to ≤ 1 cm in their GTD after treatment, or by more than 75% bin the sum of the products of the greatest diameters (SPD);\r\nNo new sites of disease."},{"outcome_type":"secondary","measure":"One-year Rate of Overall Survival","time_frame":"12 months","description":"Rate of overall survival of study participants at one year since initiation of protocol therapy. Overall survival (OS) will be measured from the date of initiation of study treatment until date of death from any cause. In the absence of death, the follow-up will be censored at date of last contact (censored observation). Kaplan-Meier estimate of overall survival at one-year."},{"outcome_type":"secondary","measure":"One-Year Rate of Failure-Free Survival (FFS)","time_frame":"12 months","description":"Rate of failure-free survival of study participants one-year after start of protocol therapy. Failure-free survival (FFS) will be measured from the date of treatment initiation until date of documented disease progression, relapse after response, or death from any cause. For patients alive and free of relapse or progression, follow-up time will be censored at the last documented date of failure-free status. Kaplan-Meier estimate of failure-free survival at one-year."},{"outcome_type":"secondary","measure":"Rate of Toxicity Related to Protocol Therapy","time_frame":"Through Duration of Protocol Therapy, Up to six 21-day cycles (+/- 7 days)","description":"Rate of adverse events, serious adverse events or other toxicities related to protocol therapy in study participants."},{"outcome_type":"secondary","measure":"HIV Viral Load in Positive Subjects Before, During and After Protocol Therapy","time_frame":"From Baseline Up to 1 Year Post-Therapy","description":"Measurement of HIV Viral Load in positive subjects before, during and after protocol therapy to assess the effect of protocol therapy on immune reconstitution or exhaustion."},{"outcome_type":"secondary","measure":"T-Cell Subset Levels in Peripheral Blood in Positive Participants Before, During and After Protocol Therapy","time_frame":"From Baseline Up to 1 Year Post-Therapy","description":"Measurement of T-cell subset levels (CD4, CD8) in peripheral blood before, during and after protocol therapy to assess the effect of protocol therapy on immune re-constitution or exhaustion."},{"outcome_type":"secondary","measure":"EBV Viral Load in Peripheral Blood Before, During and After Protocol Therapy","time_frame":"From Baseline Up to 1 year Post-Therapy","description":"Measurement of Epstein Barr Virus (EBV) viral load in peripheral blood in study participants before, after treatment, and during surveillance in order to correlate the presence of with tumor load and disease status."},{"outcome_type":"secondary","measure":"EBV Reactivation in Circulating Peripheral Blood Memory B-cells Before and After Protocol Therapy.","time_frame":"From Baseline Up to 1 year Post-Therapy","description":"Measurement of EBV reactivation in circulating peripheral blood memory B-cells before and after treatment with chemotherapy/Zidovudine (ZDV) in order to assess the drug effect on EBV latency."},{"outcome_type":"secondary","measure":"Baseline Tumor EBV Gene Expression Profile in Study Participants","time_frame":"Baseline","description":"Determine baseline tumor EBV gene expression profile to assess viral thymidine kinases. (BXLF1/vTK and BGLF4/PK), EBV latency pattern (I, II or III) and lytic phase."},{"outcome_type":"secondary","measure":"Measurement of Immune Activation Markers and Inflammation in Peripheral Blood","time_frame":"Through Duration of Response to Protocol Therapy Until Disease Progression, Up to 5 years","description":"Measurement of immune activation markers and inflammation in peripheral blood in response to treatment and EBV reactivation."}]}
{"nct_id":"NCT00884416","start_date":"2009-03-31","phase":"Phase 1","enrollment":17,"brief_title":"Sorafenib in Newly Diagnosed High Grade Glioma","official_title":"Phase I Dose Finding Study of Sorafenib in Combination With Radiation Therapy and Temozolomide as a First Line Treatment of Patients With High Grade Glioma","primary_completion_date":"2011-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-03-31","last_update":"2014-11-04","description":"This is a phase I study to evaluate the safety and tolerability of Sorafenib in combination with Temodar and radiation therapy in patients with newly diagnosed high grade glioma (glioblastoma, gliosarcoma, anaplastic astrocytoma and anaplastic oligodendroglioma or oligoastrocytoma). The mechanism of action of sorafenib, an oral multikinase inhibitor, makes it an interesting drug to investigate in the treatment of patients with high grade glioma as this agent has anti-angiogenic activity and inhibits other pathways such as Ras, Platelet-derived growth factor (PDGF) and fms-like tyrosine kinase receptor-3 (Flt-3), which are potential targets against gliomas.","other_id":"08-122","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histological documentation of newly diagnosed malignant glioma\r\n\r\n          -  ECOG performance status of 0 or 1\r\n\r\n          -  Age 18\r\n\r\n          -  Life expectancy of at least 12 weeks\r\n\r\n          -  Hemoglobin  9.0 g/dl\r\n\r\n          -  Granulocyte count 1.5 X 10^9/L\r\n\r\n          -  Platelet count 100 X 10^9/L\r\n\r\n          -  SGOT  2.5X upper limit of normal (ULN)\r\n\r\n          -  SGPT  2.5X upper limit of normal (ULN)\r\n\r\n          -  Alkaline phosphatase 4x ULN\r\n\r\n          -  Serum creatinine 1.5X ULN\r\n\r\n          -  Bilirubin 1.5X ULN\r\n\r\n          -  Spontaneous PT-INR/PTT < 1.5x upper limit of normal (patients on therapeutic\r\n             anticoagulation will be allowed to participate.\r\n\r\n          -  Patients must be on a stable or decreasing dose of corticosteroids for at least 2\r\n             weeks\r\n\r\n          -  Patient for whom a first line treatment with temozolomide and radiotherapy is adequate\r\n\r\n          -  Prophylactic anti-emetic, pentamidine inhalation / co-trimoxazole and anticonvulsants\r\n             are allowed\r\n\r\n          -  All patients must sign written informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior treatment for high grade glioma\r\n\r\n          -  Previous exposure to Ras pathway inhibitors\r\n\r\n          -  Other concurrent active malignancy (with the exception of cervical carcinoma in situ\r\n             or non melanoma carcinoma of the skin, superficial bladder tumor [Ta, Tis & T1] or any\r\n             cancer curatively treated > 3 years prior to study entry).\r\n\r\n          -  Serious medical or psychiatric illness that would, in the opinion of the investigator,\r\n             interfere with the prescribed treatment, including but not limited to: Congestive\r\n             heart failure > NYHA class 2, active CAD, cardiac arrythmias requiring anti-arrythmic\r\n             therapy or uncontrolled hypertension within the last 12 months\r\n\r\n          -  Any condition limiting the patient's judgment capacity\r\n\r\n          -  History of HIV infection, chronic hepatitis C or B as well as clinically active\r\n             infections (> grade 2 NCI-CTC version 3.0)\r\n\r\n          -  History of organ allograft\r\n\r\n          -  Renal dialysis\r\n\r\n          -  Evidence or history of bleeding diathesis\r\n\r\n          -  Major surgery within 4 weeks of start of study treatment, except for neurosurgical\r\n             resection\r\n\r\n          -  Autologous bone marrow transplant or stem cell rescue within 4 months of study\r\n\r\n          -  Substance abuse, medical, psychological or social conditions that may interfere with\r\n             the patient's participation in the study or evaluation of study results.\r\n\r\n          -  Medical condition that prevents the patient from swallowing pills\r\n\r\n          -  Use of biologic response modifiers, such as G-CSF within 3 week of study entry.\r\n\r\n          -  Pregnant or breast-feeding women.\r\n\r\n          -  Refusal to use effective contraception. Women of childbearing potential must have a\r\n             negative pregnancy test performed within 7 days of the start of treatment. Both men\r\n             and women enrolled in this trial must use adequate barrier birth control measures\r\n             during the course of the trial and for at least 3 months after administration of study\r\n             medication.\r\n\r\n          -  Known or suspected allergy to the investigational agent or any agent given in\r\n             association with this trial.\r\n      ","sponsor":"University Hospital, Geneva","sponsor_type":"Other","conditions":"Glioblastoma|Gliosarcoma|Anaplastic Astrocytoma|Anaplastic Oligoastrocytoma|Anaplastic Oligodendroglioma","interventions":[{"intervention_type":"Drug","name":"Drug: Sorafenib dose escalation","description":"Sorafenib dose escalation scheme: 3 first patients: 200 mg/d, if dose limiting toxicities (DLT) not reached: 3 patients at 200 mg BID, if no DLT reached: 3 patients at 400 mg bid"}],"outcomes":[{"outcome_type":"primary","measure":"Safety and tolerability of sorafenib in combination with radiation and temozolomide chemotherapy","time_frame":"35 weeks","description":"Safety and tolerability of sorafenib in combination with radiation and temozolomide chemotherapy in patients with newly diagnosed high grade glioma"},{"outcome_type":"secondary","measure":"Maximum Observed Plasma Concentration (Cmax) and Area under the curve (AUC) of sorafenib and temozolomide","time_frame":"0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post dose"},{"outcome_type":"secondary","measure":"Response rate","time_frame":"35 weeks"},{"outcome_type":"secondary","measure":"Time to treatment failure","time_frame":"20 months"},{"outcome_type":"secondary","measure":"6 month progression-free survival","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Event free survival","time_frame":"20 months"},{"outcome_type":"secondary","measure":"Overall survival","time_frame":"20 months"}]}
{"nct_id":"NCT00842556","start_date":"2009-03-31","phase":"Phase 1","enrollment":18,"brief_title":"Pharmacokinetic Drug Interaction Study of Dapagliflozin and Glimepiride or Sitagliptin in Healthy Subjects","official_title":"Pharmacokinetic Drug Interaction Study of Dapagliflozin and Glimepiride or Sitagliptin in Healthy Subjects","primary_completion_date":"2009-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-05-31","last_update":"2016-10-17","description":"To assess the effect of glimepiride on the PK of dapagliflozin and the effect of dapagliflozin on the PK of glimepiride, when co-administered in healthy subjects (Phase A) and to assess the effect of sitagliptin on the PK of dapagliflozin and the effect of dapagliflozin on the PK of sitagliptin, when co-administered in healthy subjects (Phase B)","other_id":"MB102-037","allocation":"Randomized","intervention_model":"Crossover Assignment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy subjects as determined by no clinically significant deviation from normal in\r\n             medical history, physical examination, ECGs, and clinical laboratory determinations\r\n\r\n          -  Body mass index (BMI) of 18 to 32 kg/m2, inclusive BMI = weight (kg)/[height(m)]2\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for\r\n             the entire study period and for up to 12 weeks after the last dose of investigational\r\n             product\r\n\r\n          -  Abnormal liver functions tests (ALT, AST or total bilirubin > 10% above ULN)\r\n\r\n          -  History of chronic or recurrent UTI (defined as 3 occurrences per year) or UTI in the\r\n             past 3 months\r\n\r\n          -  History of allergy to SGLT@ inhibitors, DPP$ inhibitors or sulfonylurea or related\r\n             compounds\r\n\r\n          -  Prior exposure to dapagliflozin, sitagliptin and glimepiride within 3 months of Day -1\r\n\r\n          -  History of recurrent (defined as 3 occurrences per year) or recent vulvovaginal\r\n             mycotic infections\r\n      ","sponsor":"AstraZeneca","sponsor_type":"Industry","conditions":"Type 2 Diabetes Mellitus","interventions":[{"intervention_type":"Drug","name":"Drug: Dapagliflozin","description":"Tablets, Oral, 20 mg, Single Dose"},{"intervention_type":"Drug","name":"Drug: Glimepiride","description":"Tablets, Oral, 4 mg, Single Dose"},{"intervention_type":"Drug","name":"Drug: Sitagliptin","description":"Tablets, Oral, 100 mg, Single Dose"}],"outcomes":[{"outcome_type":"primary","measure":"Exposure to the investigational drug will be measured to compare with and without the co-administration of other drugs","time_frame":"72 hours after dosing"},{"outcome_type":"secondary","measure":"To assess the safety and tolerability in healthy subjects","time_frame":"15 time points up to 72 hours after dosing"}]}
{"nct_id":"NCT00855868","start_date":"2009-03-31","phase":"Phase 2","enrollment":28,"brief_title":"Ability Of ([18F]-AV-45) PET Scan to Distinguish Alzheimer's Disease Subjects From Cognitively Normal Individuals","official_title":"Evaluation of the Ability of a Novel [18F] Amyloid Ligand ([18F]-AV-45) to Distinguish Patients With a Clinical Diagnosis of Alzheimer's Disease From Cognitively Normal Elderly Individuals","primary_completion_date":"2011-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-01-31","last_update":"2012-07-26","description":"This study will evaluate the performance characteristics of a novel [18F] amyloid detection ligand (18F]-AV-45) with respect to its ability to distinguish patients with clinically-diagnosed probable Alzheimer's disease from cognitively normal elderly subjects and to independently compare its diagnostic performance characteristics with the ability of [11C]PIB to correctly categorize the same subjects. SPECIFIC HYPOTHESES 1. Individuals with a clinical diagnosis of probable Alzheimer's disease will have increased brain retention of [18F]-AV-45 compared to cognitively normal elderly individuals. 2. There will be no clinically meaningful difference in the amyloid retention performance characteristics of [18F]-AV-45 and [l1C]PIB.","other_id":"ACRIN PA 4003","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":55,"maximum_age":90,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Normal subjects: mini-mental state examination (MMSE) 27-30, clinical dementia rating\r\n             (CDR) = 0, no symptoms of depression\r\n\r\n          -  Alzheimer's subjects: MMSE 18-26, CDR >=0.5, University of Pennsylvania Alzheimer's\r\n             Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  other neurological disease\r\n\r\n          -  evidence of MRI abnormality\r\n\r\n          -  psychiatric disorder\r\n\r\n          -  alcohol abuse\r\n\r\n          -  clinically significant lab abnormalities\r\n\r\n          -  residence in nursing facility\r\n\r\n          -  participation in clinical trial with experimental medication in past 1 month\r\n      ","sponsor":"Avid Radiopharmaceuticals","sponsor_type":"Industry","conditions":"Alzheimer's Disease","interventions":[{"intervention_type":"Drug","name":"Drug: florbetapir F 18","description":"370 MBq (10 mCi), intravenous (IV) injection, single dose"},{"intervention_type":"Drug","name":"Drug: [11C]-PIB","description":"555 MBq (15 mCi), IV injection, single dose [11C]-PIB"}],"outcomes":[{"outcome_type":"primary","measure":"Differences in Standard Uptake Value Ratio (SUVR) for Frontal Cortex/Cerebellum and Whole Brain/Cerebellum of the Positron Emission Tomography (PET) Scan With [18F]-AV-45 for Probable Alzheimer's Disease (AD) Versus Cognitively Normal Subjects.","time_frame":"28 d","description":"Standardized Uptake Value ratio (SUVR) as measured in this study indicates the ratio of tracer uptake in the frontal cortex relative to the cerebellum or the ratio of tracer uptake in the whole brain relative to the cerebellum."}]}
{"nct_id":"NCT01131494","start_date":"2009-03-31","phase":"N/A","enrollment":17,"brief_title":"Swallowing Training in Parkinson's Disease","official_title":"Dysphagia Therapy for Parkinson's Disease: the Role of the Oral Motor Exercises","primary_completion_date":"2010-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-12-31","last_update":"2011-11-08","description":"Dysphagia in Parkinson's disease(PD) is common and its presence is related to motor and sensory abnormalities, and incoordination between swallowing and breathing. Despite harming as respiratory infections and increased risk of death, treatment of this condition remains uncertain. This study aims to evaluate the effect of oral motor exercises on the swallowing dynamics and quality of life of dysphagic Parkinson's disease patients. This study is an open trial, self-paired and blinded to the examiner. The participants will perform oropharyngeal exercises for five weeks and will be evaluated before and after intervention by swallowing videofluoroscopy and questionnaires about quality of life in dysphagia (SWAL-QOL).","other_id":"249/2008","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Clinical diagnosis of Parkinson disease\r\n\r\n          -  Complaint of dysphagia\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Hoehn and Yahr stage 5\r\n\r\n          -  Other neurological conditions\r\n\r\n          -  Therapy for swallowing in the last 3 months\r\n\r\n          -  Cognitive disorders\r\n\r\n          -  Psychiatric disorders\r\n      ","sponsor":"Federal University of Bahia","sponsor_type":"Other","conditions":"Parkinson's Disease|Deglutition Disorders|Voice Disorders","interventions":[{"intervention_type":"Other","name":"Other: Motor exercises for swallowing, breathing and phonation","description":"This exercises aimed to increase strength and range of motion of mouth, larynx and pharynx structures. All patients made sustained vowel phonation of /a/, pushing plosive phonemes /pa/, /ta/, /ka/ in a forceful manner, suction of wet gauze, swallowing with tongue hold and modified supraglottic maneuver, in ten repetitions, ascending and descending gliding phonation of vowel /a/ and /u/, five repetitions of each vowel, and tongue rotation in oral vestibule, 3 series of 5 repetitions to each side. Patients underwent oral motor exercises twice a day, five days a week, for five weeks."}],"outcomes":[{"outcome_type":"primary","measure":"Oropharyngeal Swallowing Score","time_frame":"five weeks","description":"Based on videofluoroscopy, were awarded points for the swallowing events according to their clinical relevance. The sum of these points results in the OSP (Oropharyngeal Swallowing Score), so that higher scores signify greater impairment in swallowing. OSP-score range from 0 to 243.5. This tool is being validated for that group."},{"outcome_type":"secondary","measure":"Quality of Life","time_frame":"five weeks","description":"Measured by the Swal-qol (Quality of life in Swallowing disorders). In this questionnaire the score range from 0 to 100 and higher scores is better quality of life."}]}
{"nct_id":"NCT00827892","start_date":"2009-03-31","phase":"Phase 2","enrollment":84,"brief_title":"Safety of Pioglitazone for Hematoma Resolution In Intracerebral Hemorrhage","official_title":"Safety of Pioglitazone for Hematoma Resolution In Intracerebral Hemorrhage","primary_completion_date":"2013-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-11-30","last_update":"2015-10-02","description":"Intracerebral hemorrhage (ICH) is a devastating disease with less than 20% of survivors being independent at 6 months. There is currently no approved treatment for ICH which has been shown to improve outcomes. In an effort to develop a new treatment for ICH, this research focuses on a different aspect of ICH treatment which has not yet been evaluated: enhancing absorption of the blood clot with medication.","other_id":"HSC-MS-08-0410","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. age 18-80 years\r\n\r\n          2. clinical presentation of spontaneous ICH\r\n\r\n          3. CT scan compatible with spontaneous ICH\r\n\r\n          4. Time to PIO treatment  24 hours from symptom onset\r\n\r\n          5. GCS  6 on initial presentation OR improvement to a GCS  6 within the time frame for\r\n             enrollment\r\n\r\n          6. Hematoma volume  5cc on initial head CT.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Participation in another investigational trial in the previous 30 days\r\n\r\n          2. Patient will undergo surgical evacuation of ICH (ventriculostomy does NOT exclude\r\n             patient)\r\n\r\n          3. Inability to undergo neuroimaging with MRI (e.g. pacer, recent stent, inability to lie\r\n             flat)\r\n\r\n             a. If patient has mild claustrophobia or agitation amenable to mild sedation (1-2mg\r\n             lorazepam IV or 5-10mg diazepam PO), he or she may be considered for enrollment. If,\r\n             however, the patient has severe claustrophobia or agitation, he or she should not be\r\n             considered for enrollment.\r\n\r\n          4. GCS < 6\r\n\r\n          5. Baseline mRS  3\r\n\r\n          6. Primary intraventricular hemorrhage\r\n\r\n          7. ICH due to coagulopathy (PT > 15 sec or INR > 1.3, PTT > 36) or trauma\r\n\r\n          8. History of intolerance or allergy to any TZD\r\n\r\n          9. Thrombocytopenia: platelet count < 100,000\r\n\r\n         10. Clinically significant hepatic disease as demonstrated by history, clinical exam\r\n             (ascites, varices), or laboratory findings (LFTs  2x normal, coagulopathy as\r\n             described above)\r\n\r\n         11. Co-morbid conditions, which in the opinion of the investigator, are likely to\r\n             complicate therapy including but not limited to:\r\n\r\n               1. A history of NYHA class II, III, or IV CHF\r\n\r\n               2. clinically significant arrhythmia\r\n\r\n               3. end stage AIDS\r\n\r\n         12. Pregnancy as determined by a urine pregnancy test\r\n\r\n         13. Severe anemia at presentation: hemoglobin < 10 g/dL or hematocrit < 30%\r\n\r\n         14. Malignancy (history of or active)\r\n\r\n         15. Patient unlikely, in the investigator's opinion, to complete the study and return for\r\n             follow-up visits for any reason\r\n      ","sponsor":"The University of Texas Health Science Center, Houston","sponsor_type":"Other","conditions":"Intracerebral Hemorrhage","interventions":[{"intervention_type":"Drug","name":"Drug: Pioglitazone","description":"Escalating doses for 3 days, then 30 mg orally daily for the duration of the study as determined by MRI"},{"intervention_type":"Drug","name":"Drug: Placebo Control","description":"Lactose Capsule administered by mouth daily for the duration of the study as determined by MRI"}],"outcomes":[{"outcome_type":"primary","measure":"The primary measure of safety will be mortality at discharge.","time_frame":"At hospital discharge or Day 14, whichever occurs first."},{"outcome_type":"secondary","measure":"Secondary measures of safety will include mortality at 3 months and 6 months, symptomatic cerebral edema during hospitalization, clinically significant congestive heart failure, edema, hypoglycemia, anemia, and hepatotoxicity.","time_frame":"3 months, 6 months, and during hospitalization"}]}
{"nct_id":"NCT00851890","start_date":"2009-03-31","phase":"Phase 2","enrollment":30,"brief_title":"A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Multiple Doses of ABT-333 Alone and in Combination With Pegylated Interferon (pegIFN) and Ribavirin (RBV) in Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection","official_title":"A Blinded, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Multiple Doses of ABT-333 Alone and in Combination With Pegylated Interferon (pegIFN) and Ribavirin (RBV) in Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection","primary_completion_date":"2009-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-07-31","last_update":"2018-07-02","description":"The purpose of this study was to assess the safety, tolerability, pharmacokinetics and antiviral activity of ABT-333 (also known as dasabuvir) in treatment-nave, hepatitis C virus (HCV)-infected participants.","other_id":"M10-380","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Participant has provided written consent.\r\n\r\n          -  If female, participant is postmenopausal or surgically sterile.\r\n\r\n          -  If male, must be practicing two effective methods of birth control.\r\n\r\n          -  Participant is hepatitis C virus (HCV) genotype 1 with HCV ribonucleic acid levels\r\n             >50,000 IU/mL.\r\n\r\n          -  Participants must demonstrate chronic hepatitis C infection for at least 6 months\r\n             prior to study enrollment.\r\n\r\n          -  Participants must have a liver biopsy with histology consistent with HCV-induced liver\r\n             damage, and with no evidence of cirrhosis or liver pathology due to any cause other\r\n             than chronic HCV.\r\n\r\n          -  Condition of general good health other then HCV infection.\r\n\r\n          -  Participants with a history of thyroid disease must have a thyroid stimulating hormone\r\n             (TSH) value in the normal range.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  No prior history of receiving therapy for HCV infection.\r\n\r\n          -  Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B\r\n             surface antigen (HBsAg), or human immunodeficiency virus antibody (HIV Ab).\r\n\r\n          -  Pregnant or breastfeeding females or male partners of women who are pregnant.\r\n\r\n          -  History of seizures or cancer.\r\n\r\n          -  History of major depressive disorder within 2 years.\r\n\r\n          -  Any current or past history of cirrhosis.\r\n\r\n          -  Any cause of liver disease other than chronic HCV infection.\r\n      ","sponsor":"AbbVie (prior sponsor, Abbott)","sponsor_type":"Industry","conditions":"Chronic Hepatitis C Virus Infection","interventions":[{"intervention_type":"Drug","name":"Drug: ABT-333","description":"50 mg capsules"},{"intervention_type":"Other","name":"Other: Placebo for ABT-333","description":"Capsule"},{"intervention_type":"Drug","name":"Drug: Pegylated interferon","description":"Syringe, 180 g/0.5 mL for subcutaneous injections administered weekly"},{"intervention_type":"Drug","name":"Drug: Ribavirin","description":"200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day"}],"outcomes":[{"outcome_type":"primary","measure":"Mean Maximal Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels During ABT-333 Monotherapy Treatment","time_frame":"Prior to the first dose on Day 1 to before first dose on Day 3","description":"Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (reported as log10 IU/mL) were determined for each sample using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The baseline value was the HCV RNA measurement before the first dose of ABT-333 on Day 1. The maximal change during monotherapy was nadir minus the baseline log10 HCV RNA level. Nadir was defined as the lowest log10 HCV RNA level any time after the first dose of study drug on Day 1 through the last log10 HCV RNA level before the first dose of study drug on Day 3. Data are reported as the least squares mean change from nadir ± standard error."},{"outcome_type":"primary","measure":"Mean Maximal Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels Through Day 28","time_frame":"Prior to the first dose on Day 1 through Day 28","description":"Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (reported as log10 IU/mL) were determined for each sample using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The baseline value was the HCV RNA measurement before the first dose of ABT-333 on Day 1. The maximal change during treatment was nadir minus the baseline log10 HCV RNA level. Nadir was defined as the lowest log10 HCV RNA level any time after the first dose of study drug on Day 1 through the last log10 HCV RNA level on Day 28. Data are reported as the least squares mean change from nadir ± standard error."},{"outcome_type":"primary","measure":"Maximum Plasma Concentration (Cmax) of ABT-333","time_frame":"Pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours post-dose on Day 1; and pre-dose on Day 2","description":"Blood samples were collected pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and pre-dose on Day 2. The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation."},{"outcome_type":"primary","measure":"Time to Maximum Plasma Concentration (Tmax) of ABT-333","time_frame":"Pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours post-dose on Day 1; and pre-dose on Day 2","description":"Blood samples were collected pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and pre-dose on Day 2. The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation."},{"outcome_type":"primary","measure":"Area Under the Plasma Concentration-time Curve From 0 to 12 Hours Post-dose (AUC12) of ABT-333","time_frame":"Pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours post-dose on Day 1; and pre-dose on Day 2","description":"Blood samples were collected pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and pre-dose on Day 2. The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) measures the total exposure of a drug in blood plasma. The AUC12 of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation."},{"outcome_type":"primary","measure":"Serum Concentrations of Pegylated Interferon (pegIFN)","time_frame":"Prior to the morning dose on Day 3; 4 hours after the morning dose on Day 3; prior to the morning dose on Days 4 and 5; and single samples were collected on Days 10, 17, 24, and 28","description":"Blood samples were collected prior to the morning dose on Day 3; 4 hours after the morning dose on Day 3; prior to the morning dose on Days 4 and 5; and single samples were collected on Days 10, 17, 24, and 28. The samples were analyzed for the concentration of pegIFN (measured in ng/mL) using validated analytical methods and estimated using non-compartmental methods. Data are reported as the mean ± standard deviation."},{"outcome_type":"primary","measure":"Plasma Concentrations of Ribavirin (RBV)","time_frame":"Prior to the morning dose on Day 3; 4 hours after the morning dose on Day 3; prior to the morning dose on Days 4 and 5; and single samples were collected on Days 10, 17, 24, and 28","description":"Blood samples were collected prior to the morning dose on Day 3; 4 hours after the morning dose on Day 3; prior to the morning dose on Days 4 and 5; and single samples were collected on Days 10, 17, 24, and 28. The samples were analyzed for the concentration of RBV (measured in ng/mL) using validated analytical methods and estimated using non-compartmental methods. Data are reported as the mean ± standard deviation."},{"outcome_type":"primary","measure":"Number of Participants Having Treatment-emergent Adverse Events (AEs)","time_frame":"AEs were collected from the time of study drug administration to 30 days after last dose of study drug (8 Weeks)","description":"An AE was any untoward medical occurrence that did not have a causal relationship with treatment. An Adverse Drug Reaction (ADR) was any noxious and undesired reaction related to the experimental drug or experiment. A serious adverse event (SAE) was an AE that resulted in death, was life-threatening, resulted in or prolonged hospitalization, resulted in congenital anomaly, was persistent or caused significant disability/incapacity, spontaneous or elective abortion, or required intervention to prevent a serious outcome. AEs were rated for severity as either:\r\nMild - transient and easily tolerated;\r\nModerate - caused discomfort and interrupted usual activities;\r\nSevere - caused considerable interference with usual activities, may be incapacitating or life-threatening.\r\nAEs related to direct-acting antiviral agents (DAAs) were assessed as being either probably or possibly related by the investigator."},{"outcome_type":"secondary","measure":"Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels Through Day 28 or Final Visit","time_frame":"Day 28 and Final Visit","description":"Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (reported as log10 IU/mL) were determined using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The baseline value was the HCV RNA measurement before the first dose of ABT-333 on Day 1 and the Day 28 or Final Visit value was the last HCV RNA measurement during the study. Data are reported as the least squares mean change from baseline ± standard error."},{"outcome_type":"secondary","measure":"Percentage of Participants With at Least a 2 log10 Maximal Decrease in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels During ABT-333 Treatment","time_frame":"Prior to the first dose on Day 1 and Day 28","description":"Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The baseline value was the HCV RNA measurement before the first dose of ABT-333 on Day 1. Data are reported as the percentage of participants."},{"outcome_type":"secondary","measure":"Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels ≤ 25 IU/mL (the Lower Limit of Quantitation [LLOQ]) at Day 28 or Final Visit","time_frame":"Day 28 or Final Visit","description":"Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The lower limit of quantification (LLOQ) was defined as HCV RNA levels ≤ 25 IU/mL. Data are reported as the percentage of participants."},{"outcome_type":"secondary","measure":"Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels ≤ 10 IU/mL (Lower Limit of Detection [LLOD]) at Day 28 or Final Visit","time_frame":"Day 28 or Final Visit","description":"Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The lower limit of detection (LLOD) was defined as a HCV RNA level equal to 10 IU/mL. Data are reported as the percentage of participants."},{"outcome_type":"secondary","measure":"Number of Participants With Resistance-Associated Variants in Non-structural Viral Protein 5B (NS5B) Through Day 28","time_frame":"Days 1, 5, 10, 17, 24 and 28","description":"Samples from Days 1, 5, 10, 17, 24 and 28 were analyzed for the presence of resistance-associated amino acids using population sequencing and compared to the baseline non-structural viral protein 5B (NS5B) sequence to assess amino acid changes. The amino acid sequence of NS5B before the first dose of ABT-333 on Day 1 was defined as the baseline sequence. The number of participants with variants at resistance-associated amino acid positions in the post-baseline samples are presented."},{"outcome_type":"secondary","measure":"Number of Participants With Maximal Phenotypic Resistance to ABT-333 >10 Fold Relative to Baseline Through Day 28","time_frame":"Days 1 through 28","description":"Phenotypic resistance to ABT-333 was assessed by calculating the fold difference in the half maximal effective concentration (EC50) compared with the EC50 for the corresponding baseline sample, and the maximal fold change in EC50 from baseline over the Day 5-28 period. The resistance sample drawn before the first dose of ABT-333 on Day 1 was defined as the baseline sample. The number of participants with phenotypic resistance in the post-baseline samples are presented."}]}
{"nct_id":"NCT01052974","start_date":"2009-03-26","phase":"Phase 4","enrollment":60,"brief_title":"Perioperative Analgesia by Femoral Perineural Catheter for Femoral Neck Fracture - Study KTcol","official_title":"Perioperative Analgesia by Femoral Perineural Catheter for Femoral Neck Fracture - Study KTcol -","primary_completion_date":"2010-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-11-09","last_update":"2017-11-01","description":"Therapeutic essay of phase IV, monocentric, prospective, randomized, in double-blind during 48 hours(then simple-blind),controlled by placebo. Abstract: The increasing incidence of the number of femoral neck fractures and the poor prognosis of this traumatological pathology involves an optimization of the diagnostic, therapeutic and analgesic care. A widespread collectively practice for the analgesia in prehospital or preoperative period is the single injection (\"single shot\") of local anesthetic with the technique of the femoral or iliofascial block. Nevertheless the single injection of a dose of local anesthetic associated or not with analgesic adjuvants, due to their pharmacological properties, can't prolong the efficiency of the loco-regional analgesia more than 12 hours. The aim of our study is to evaluate, in the patients admitted in emergencies for suspicion of femoral neck fractures, the perioperative efficiency of an analgesic treatment using a femoral perineural catheter (inserted from the hospital admission) with continuous infusion of ropivacane controlled by placebo (physiological serum).","other_id":"AOI2008-07","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  femoral neck fracture\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Contraindication with analgesia\r\n      ","sponsor":"University Hospital, Angers","sponsor_type":"Other","conditions":"Femoral Neck Fracture","interventions":[{"intervention_type":"Drug","name":"Drug: ropivacaine","description":"A widespread collectively practice for the analgesia in prehospital or preoperative period is the single injection of local anesthetic with the technique of the femoral or iliofascial block.\r\nIntervention: Analgesic treatment using a femoral perineural catheter (inserted from the hospital admission) with continuous infusion of ropivacane controlled by placebo."}],"outcomes":[{"outcome_type":"primary","measure":"evaluate, in the patients admitted in emergencies for suspicion of femoral neck fractures, the perioperative efficiency of an analgesic treatment using a femoral perineural catheter","time_frame":"from the hospital admission to 24h after surgical operation"}]}
{"nct_id":"NCT00847067","start_date":"2009-02-28","phase":"N/A","enrollment":40,"brief_title":"Chronic Post Breast Surgery Pain","official_title":"A Prospective, Single-blinded, Randomized, Trial Evaluating the Use of Paravertebral Block to Decrease Chronic Post Breast Surgery Pain.","primary_completion_date":"2010-04-30","study_type":"Interventional","rec_status":"Terminated","completion_date":"2010-04-30","last_update":"2010-06-11","description":"The purpose of this study is to learn if paravertebral block (PVB) will reduce chronic pain after surgery. Our hypothesis is that chronic pain from breast surgery as a consequence of central sensitization can be prevented by blocking sensory input to the CNS during surgery and the immediate post-operative period.","other_id":"08-004783","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"Quadruple","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Female patient who are  18 and  80 years of age.\r\n\r\n          2. Patient with diagnosis of breast cancer.\r\n\r\n          3. Patient scheduled for modified radical mastectomy or lumpectomy with axillary node\r\n             dissection\r\n\r\n          4. Patient scheduled for one of the above listed surgeries with or without sentinel,\r\n             partial, or complete axillary lymph node dissection\r\n\r\n          5. Patients scheduled for one of the aforementioned surgeries with or without immediate\r\n             or delayed reconstruction.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Pre-existing peripheral neuropathy\r\n\r\n          2. Pre-existing chronic pain\r\n\r\n          3. Bilateral procedure\r\n\r\n          4. Previous breast surgery, except biopsy\r\n\r\n          5. Inability to read, write or speak English.\r\n\r\n          6. Allergy to amide local anesthetics\r\n\r\n          7. Contraindications to paravertebral nerve block including, but not limited to severe\r\n             scoliosis of the spine, skin lesion overlying the block area, abnormal coagulation\r\n             studies (some of these may not be known until after informed consent is obtained)\r\n\r\n          8. Pregnancy\r\n\r\n          9. Emergency surgery\r\n\r\n         10. Previous recipients of peripheral nerve block.\r\n\r\n         11. Medical professional whose experience includes caring for patients who have had\r\n             peripheral nerve blocks.\r\n      ","sponsor":"Mayo Clinic","sponsor_type":"Other","conditions":"Breast Cancer","interventions":[{"intervention_type":"Procedure","name":"Procedure: Paravertebral block","description":"3ml 1% Ropivacaine at each level T1 - T5"},{"intervention_type":"Procedure","name":"Procedure: Sham injections","description":"Sham injections with Normal Saline"}],"outcomes":[{"outcome_type":"primary","measure":"To obtain practical experience and information with which to develop a larger, more definitive study, particularly with regard to distributions of VAS responses at 3 months, patient compliance, and achievable accrual rate.","time_frame":"3 months"}]}
{"nct_id":"NCT00890539","start_date":"2009-02-28","phase":"N/A","enrollment":15,"brief_title":"Methacholine Challenge: Comparison of Doubling and Quadrupling Methacholine Dose Regimes Using the Tidal Volume Method","official_title":"Methacholine Challenge: Comparison of Doubling and Quadrupling Methacholine Dose Regimes Using the Tidal Volume Method","primary_completion_date":"2009-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-03-31","last_update":"2009-11-25","description":"The purpose of this study is to determine the difference (if any) in the result of the methacholine challenge (a test used by physicians in diagnosing asthma) when concentrations of methacholine are quadrupled versus doubled.","other_id":"BMC08-247","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  You must be over 18 years of age; and\r\n\r\n          -  You must have a diagnosis of asthma; and\r\n\r\n          -  Excluding asthma, you are not aware of any other lung conditions or diseases.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  You have a known hypersensitivity (i.e. an overreaction of your immune system) to\r\n             methacholine or other parasympathomimetic agents or cholinesterase inhibitors (i.e.\r\n             agents that act in a similar way via your nervous system - to be discussed with study\r\n             personnel); or\r\n\r\n          -  You are a nursing mother or if you are a woman of child bearing potential who is, may\r\n             be, or intends to become pregnant during testing as the effects of methacholine\r\n             inhalation in these situations are not known; or\r\n\r\n          -  Your baseline lung function is poor (ie. your FEV or forced expiratory volume in one\r\n             second, is less than 65% of your predicted values). This will be performed and\r\n             explained by study personnel prior to commencing methacholine inhalation testing; or\r\n\r\n          -  You have had any respiratory infections for the last four weeks; or\r\n\r\n          -  If you have allergies, and have been exposed to agents that trigger your asthma within\r\n             the last four weeks; or\r\n\r\n          -  If you have any significant chronic medical condition.\r\n      ","sponsor":"University of Saskatchewan","sponsor_type":"Other","conditions":"Asthma","interventions":[{"intervention_type":"Drug","name":"Drug: Methacholine challenge","description":"Clinical and research test used in asthma"}],"outcomes":[{"outcome_type":"primary","measure":"Methacholine PC20","time_frame":"1 week"},{"outcome_type":"secondary","measure":"Subject measure of breathlessness - modified Borg scale","time_frame":"1 week"}]}
{"nct_id":"NCT01939652","start_date":"2009-02-28","phase":"Early Phase 1","enrollment":60,"brief_title":"Restrictive Versus Standard Fluid Regime in Elective Minilaparotomy Abdominal Aortic Aneurysm Repair","official_title":"Restrictive Versus Standard Fluid Regime in Elective Minilaparotomy Abdominal Aortic Aneurysm Repair","primary_completion_date":"2013-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-07-31","last_update":"2013-09-11","description":"Elective minilaparatomy abdominal aortic aneurysm (AAA) repair is associated with a significant number of complications involving respiratory, cardiovascular, gastrointestinal and central nervous system, and mortality ranging up to 5%. In our study, we tested the hypothesis that intraoperative and postoperative intravenous restrictive fluid regime reduces postoperative morbidity and mortality and improves the outcome of the treatment of minilaparotomy AAA repair.","other_id":"UKCTUZLA","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  AAA more than 5,5 cm in diameter tube graft\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  emargency comorbidity maligancy\r\n      ","sponsor":"University Clinical Center Tuzla","sponsor_type":"Other","conditions":"Abdominal Aortic Aneurysm > 5.5 cm Effect of a Restricted Intravenous Fluid Regime on Complications and Hospital Stay After the Minilaparotomy AAA Repair.","interventions":[{"intervention_type":"Procedure","name":"Procedure: Restrictive VS Standard Fluid Regime"},{"intervention_type":"Drug","name":"Drug: Drag: Crystalloids and Colloids"}],"outcomes":[{"outcome_type":"secondary","measure":"ICU and duration of Hospital stay","time_frame":"30 days"},{"outcome_type":"secondary","measure":"In-hospital mortality, 30-days mortality","time_frame":"30 days"},{"outcome_type":"secondary","measure":"Fluid balance (daily and cumulative)","time_frame":"3 days"},{"outcome_type":"primary","measure":"Number of major and minor complications","time_frame":"30 days"}]}
{"nct_id":"NCT01690793","start_date":"2009-02-28","enrollment":30,"brief_title":"Measurement of Natriuretic Hormone Peptides in Exacerbation of Asthma","official_title":"Measurement of Natriuretic Hormone Peptides in Exacerbation of Asthma","primary_completion_date":"2010-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2011-02-28","last_update":"2015-05-28","description":"The investigators hypothesize that there is a statistically significant decrease of Natriuretic Hormone Peptides (NHPs) in subjects with asthma exacerbation compared to levels following treatment of an exacerbation of asthma.","other_id":"acute asthma","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":85,"population":"The Asthma Control Test score of less than 18.\r\n\r\n        Asthma control test consists of five questions, scored 1-5 each.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Both genders, age 18-85.\r\n\r\n          -  Females who are pregnant or lactating are not eligible.\r\n\r\n          -  Read and comprehend English.\r\n\r\n          -  Ability to give informed consent.\r\n\r\n          -  Seen in the outpatient setting at one of the clinic.\r\n\r\n          -  The subject must have a history of physician diagnosed asthma for at least 1 year and\r\n             must have an exacerbation of asthma for entry into the study.\r\n      ","sponsor":"University of South Florida","sponsor_type":"Other","conditions":"ASTHMA","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"The measurement of NHPs after treatment of an exacerbation of asthma","time_frame":"14 days"}]}
{"nct_id":"NCT00775944","start_date":"2009-02-28","phase":"Phase 4","enrollment":2591,"brief_title":"Trial Comparing Different Methods of Support With Stopping Smoking (PORTSSS/Stop Together Trial)","official_title":"Trial Comparing Different Methods of Support With Stopping Smoking Offered Through The National Health Service (NHS) Smoking Helpline","primary_completion_date":"2010-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-09-30","last_update":"2012-10-26","description":"This study shall determine whether or not proactive telephone support for smoking cessation delivered to quitline callers is more effective than standard 'reactive' provision and whether or not the offer of a voucher for a cost free supply of nicotine replacement therapy (NRT) has any additional impact on smoking cessation rates achieved by behavioural interventions.","other_id":"08118","allocation":"Randomized","intervention_model":"Factorial Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":16,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Participants are over 16 and will need to agree to i) receive counselling ii) to set a\r\n             quit within two weeks and iii) consent to follow up processes.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Telephonists will not enrol potential participants who are not capable of giving\r\n             informed consent or who have not got access to a phone contact number to which calls\r\n             can be made by Essentia staff.\r\n      ","sponsor":"University of Nottingham","sponsor_type":"Other","conditions":"Tobacco Smoking","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Proactive telephone support","description":"Pro-active telephone counselling allows for repeated, sequenced calls to be made by quitline counsellors to smokers and for counselling to be provided during accepted calls."},{"intervention_type":"Behavioral","name":"Behavioral: Reactive (standard) telephone support","description":"Reactive counselling usually involves the provision of evidence-based information to support quit attempts without any or with only very brief counselling to accompany it."},{"intervention_type":"Drug","name":"Drug: Offer of voucher for cost-free Nicotine Replacement Therapy","description":"Offer of voucher for cost-free Nicotine Replacement Therapy over the telephone"}],"outcomes":[{"outcome_type":"primary","measure":"Self-reported, Prolonged Abstinence From Smoking Between a Quit Date and 6 Months Afterwards.","time_frame":"6 months from participant's quit date","description":"Prolonged abstinence was defined as not smoking between a quit date and six months later with minor smoking lapses permitted as long as no more than 5 cigarettes in total were smoked during this period."},{"outcome_type":"secondary","measure":"Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 6 Months, With Carbon Monoxide (CO) Validation.","time_frame":"Measured 6 months after participant's quit date","description":"The participant had to report not smoking for at least 7 days prior to the point of outcome assessment."},{"outcome_type":"secondary","measure":"Self-reported Abstinence From Smoking for at Least Three Months, Ascertained at 6 Months","time_frame":"Measured at 6 months after participant's quit date","description":"Participants had to report not smoking in the three months prior to outcome ascertainment."},{"outcome_type":"secondary","measure":"Self-reported Prolonged Abstinence From Smoking Between a Quit Date and 1 Month","time_frame":"Measured at 1 month after participant's quit date","description":"Prolonged abstinence was defined as not smoking between a quit date and one month later; minor lapses were permitted provided no more than 5 cigarettes in total had been smoked."},{"outcome_type":"secondary","measure":"Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 1 Month","time_frame":"Measured at 1 month after participant's quit date","description":"Participants had to report not smoking for 7 or more days prior to outcome ascertainment."},{"outcome_type":"secondary","measure":"Number of Unsuccessful Quit Attempts Lasting > 24 Hrs Reported at One and 6 Months","time_frame":"Measured 6 months after participant's quit date","description":"As title"},{"outcome_type":"secondary","measure":"Health Status at 6 Months EuroQol 5D (EQ5D)","time_frame":"Measured 6 months after participant's quit date","description":"This is a generic measure of health status used in health economic analyses."},{"outcome_type":"secondary","measure":"Use of Other NHS Smoking Cessation Interventions (e.g. Uptake of NHS Stop Smoking Services, Use of Other NRT Obtained From General Practitioner (GP) Etc.)","time_frame":"Measured 6 months after participant's quit date","description":"Participants' recall of the use they have made of other stop smoking interventions that are available through the National Health Service."}]}
{"nct_id":"NCT00763516","start_date":"2009-02-28","phase":"N/A","enrollment":8,"brief_title":"Proton Radiation for Resectable Carcinoma of the Pancreas","official_title":"A Pilot Study Using Neoadjuvant Proton Beam Radiation Therapy and Chemotherapy for Marginally Resectable Carcinoma of the Pancreas","primary_completion_date":"2017-08-17","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-08-17","last_update":"2017-09-06","description":"The purpose of this study is to find out what effects, good and/or bad, proton radiation combined with chemotherapy and surgery has on you and your pancreatic cancer. This study will look at the side effects from the treatment and the quality of your life in relation to pain. It will also look at how the tumor responds to the combination of treatment with radiation, chemotherapy and surgery.","other_id":"UFPTI 0704-PC02","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Pathologically confirmed adenocarcinoma of the pancreas.\r\n\r\n          -  Patients must have marginally resectable disease.\r\n\r\n          -  Patients with biliary obstruction must have adequate drainage prior to starting\r\n             chemoradiation.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Evidence of distant metastasis including peritoneal seeding and/or ascites.\r\n\r\n          -  Previous irradiation to the abdomen that would compromise the ability to deliver the\r\n             prescribed treatment.\r\n\r\n          -  Prior surgical resection.\r\n\r\n          -  Gastroduodenal obstruction\r\n      ","sponsor":"University of Florida","sponsor_type":"Other","conditions":"Pancreatic Cancer","interventions":[{"intervention_type":"Radiation","name":"Radiation: Proton radiation and chemotherapy","description":"Neoadjuvant Chemotherapy Capecitabine (Xeloda) 1,000 mg by mouth twice a day 5 days/week (M-F) on radiation days only\r\nProton radiation 50.4 cobalt gray equivalent(CGE) in 28 fractions over 6 weeks\r\nSurgery: Gross total resection of primary tumor and regional lymph nodes done 6 weeks after completion of radiation\r\nAdjuvant Chemotherapy starting 2-8 weeks after surgery Suggested Regimen: Gemcitabine (Gemzar) 1,000 mg/m2 IV total of 18 doses"}],"outcomes":[{"outcome_type":"primary","measure":"Cumulative incidence of grade 3+ bowel perforation, grade 3+ bleeding and grade 4+ nonhematologic acute adverse events (occuring within 90 days of treatment start)","time_frame":"1 year following the completion of radiation therapy"},{"outcome_type":"secondary","measure":"Collect and analyze tumor control outcomes","time_frame":"1 year following the completion of radiation therapy"}]}
{"nct_id":"NCT00912314","start_date":"2009-02-28","phase":"N/A","enrollment":11,"brief_title":"Trial of Maintenance Therapy With Posterior Tibial Nerve Stimulation for Overactive Bladder","official_title":"A Randomized Trial of Maintenance Therapy With Posterior Tibial Nerve Stimulation for Overactive Bladder","primary_completion_date":"2010-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-06-30","last_update":"2019-08-02","description":"This study has 2 parts. Part 1 is a 12-week observational study of weekly Posterior Tibial Nerve Stimulation (PTNS) treatment for women with overactive bladder. Part 2 is a randomized, controlled trial of monthly maintenance PTNS therapy versus no therapy in subjects who were successfully treated by PTNS in Part 1. Part 1: 12-week observational study of weekly PTNS treatment. The primary aim of Part 1 is to determine the efficacy of a 12-week course of PTNS in the treatment of overactive bladder. Secondary aims are to determine the changes in voiding frequency and quality-of-life measures after the 12-week treatment. Part 2: Randomized, controlled study of monthly PTNS compared to no PTNS after 12-week treatment The primary aim is to determine time-to-failure after 12 weeks of PTNS in subjects who receive maintenance therapy compared to those who do not, in order to ascertain if there is a need for maintenance therapy after 12 weeks of PTNS. The investigators' secondary aims are to compare the long-term efficacy and quality of life impact in patient receiving maintenance PTNS compared to those that do not and to determine the efficacy of rescue maintenance PTNS in subjects who have symptom recurrence in the no maintenance therapy arm. Hypothesis: There will be no difference in time to failure between women randomized to monthly maintenance PTNS compared to no maintenance PTNS.","other_id":"0818191","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Women with refractory overactive bladder syndrome referred to UCSD Women's Pelvic\r\n             Medicine Center by treating physician for PTNS therapy as standard of care\r\n\r\n          -  At least 18 years old\r\n\r\n          -  9 or more voids per 24 hours\r\n\r\n          -  PGI - S score of \"moderate\" or \"great\" bother\r\n\r\n          -  If on anticholinergic medication, they must be on stable dose of medications for at\r\n             least one month\r\n\r\n          -  Able to provide informed consent and complete study measures\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Postvoid residual > 150 ml to exclude subjects with urinary retention\r\n\r\n          -  Active urinary tract infection (defer entry until resolved)\r\n\r\n          -  Urine output > 2800 ml per day\r\n\r\n          -  Diagnosis of interstitial cystitis or chronic pelvic pain\r\n\r\n          -  Diagnosis of bladder cancer\r\n\r\n          -  Currently pregnant\r\n      ","sponsor":"University of California, San Diego","sponsor_type":"Other","conditions":"Overactive Bladder Syndrome","interventions":[{"intervention_type":"Procedure","name":"Procedure: PTNS","description":"Monthly PTNS after 12 weeks of weekly PTNS"}],"outcomes":[{"outcome_type":"primary","measure":"time-to-failure after 12 weeks of PTNS in subjects who receive maintenance therapy compared to those who do not","time_frame":"40 weeks"},{"outcome_type":"secondary","measure":"efficacy of a 12-week course of PTNS in the treatment of overactive bladder","time_frame":"12 weeks"}]}
{"nct_id":"NCT01323582","start_date":"2009-02-28","phase":"Phase 2","enrollment":26,"brief_title":"Comparison of Two Macrolides, Azithromycin and Erythromycin, for Symptomatic Treatment of Gastroparesis","official_title":"Comparison of Two Macrolides, Azithromycin and Erythromycin, for Symptomatic Treatment of Gastroparesis","primary_completion_date":"2012-12-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2012-12-31","last_update":"2014-12-05","description":"Erythromycin is effectively used in the treatment of Gastroparesis (GP) patients. In susceptible patients however, it has been associated with sudden cardiac death due to prolongation of QT intervals and subsequent cardiac risks through its interaction some other drugs. Azithromycin (AZI) is a macrolide antibiotic but does not have the mentioned druf interactions , has fewer gastrointestinal side effects, and fewer risks of QT prolongation and cardiac arrhythmias. Consequently, AZI avoids drawbacks of dosing with erythromycin and may be preferred as a prokinetic agent in patients on other concomitant medications. We hope to demonstrate the effectiveness of Azithromycin (AZI) as compared to Erythromycin in the treatment of Gastroparesis (GP), and later, form the framework for larger randomized-controlled parallel studies to investigate use of AZI for treatment of GP. Our novel hypothesis is to determine whether AZI can be used to treat GP.","other_id":"645-2008","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  presenting to gastroenterology motility specialty clinics at the University of Florida\r\n             (UF), who meet the clinical and radiologic diagnostic criteria for diagnosis of GP\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any history of mechanical obstruction\r\n\r\n          -  Gastrointestinal malignancy\r\n\r\n          -  Current use of prokinetics such as cisapride, pimozide, or anticholinergic medication\r\n             which cannot be discontinued 72 hrs prior to study\r\n\r\n          -  Abnormal upper endoscopy with finding of erosions or ulcerations\r\n\r\n          -  Helicobacter pylori infection in past 6 months\r\n\r\n          -  Recent abdominal surgery < 6 months\r\n\r\n          -  Cardiac history with EKG finding of QTC > 450 done on a screening test\r\n\r\n          -  Detected renal or hepatic dysfunction described as a GFR <10 ml/min and ALT/AST values\r\n             > 2 times the normal level in our laboratory\r\n\r\n          -  Allergy to macrolide antibiotics\r\n\r\n          -  Psychiatric history other than anxiety or depression\r\n\r\n          -  Predominant symptoms of irritable bowel syndrome such as constipation or diarrhea\r\n\r\n          -  Uncontrolled diabetes with fasting blood glucose levels > 180 mg/dL, due to effect of\r\n             hyperglycemia on gastric emptying. For patients with diabetes, blood glucose levels\r\n             will be recorded in a patient diary.\r\n\r\n          -  Pregnant or nursing females\r\n\r\n          -  Any history of myasthenia gravis\r\n\r\n          -  Current use of Coumadin, lovastatin, simvastatin Nelfinavir, theophylline, digoxin,\r\n             ergotamine/dihydroergotamine products, benzodiazepines, and sildenafil (this will be\r\n             discontinued for the duration of the clinical trial if subject is on this medication).\r\n\r\n          -  History of elevated liver function studies or CPKs.\r\n\r\n          -  Pregnancy : A urine pregnancy test will be performed at the beginning of each\r\n             treatment period and only subjects who are not pregnant will be enrolled for the\r\n             study.\r\n      ","sponsor":"University of Florida","sponsor_type":"Other","conditions":"Gastroparesis","interventions":[{"intervention_type":"Drug","name":"Drug: Erythromycin","description":"200mg/5ml elixir administered orally three times a day half an hour prior to meals."},{"intervention_type":"Drug","name":"Drug: Azithromycin","description":"The dose of Azithromycin given was determined based on the following study on 10 healthy subjects. In random order, each of ten healthy subjects underwent OBT studies following administration of AZI, at doses of 50mg, 100mg, and 133mg. The T and Tlag was then compared for the three doses by a randomized block analysis using Analysis of Variance followed by Tukey's multiple comparison. Results: The T for each of the respective doses of AZI (50mg, 100mg, and 133mg) was 129  27, 128  31, and 128  16 minutes (p = 0.98). This data suggested that AZI at doses of 50mg, 100mg and 133 mg have fairly similar activity in its effects on gastric emptying in healthy subjects. Based on this analysis , we decided to use a dose of 50 mg/5 ml for administered TID prior to meals."}],"outcomes":[{"outcome_type":"primary","measure":"Time in Minutes for 50% of the Ingested Meal to Empty the Stomach With a Standardized Breath Test: Half the of the Week 11 Value (Period 2) Less Half the of the Week 4 Value (Period 1). This Estimates the Effect Size.","time_frame":"Weeks 4 and 11 (end of periods)","description":"Patients will be given a standardized meal enriched with a labeled material and the breath samples are then collected and analyzed. The estimated time to empty 50% (t 1/2) of the accumulated contents is recorded. Because the difference is RX-B -RX A in one group and RX A -RX B in the other, the difference between these two estimates twice the effect size. Hence the Half is applied, as is standard in the two sample method for crossover studies."},{"outcome_type":"primary","measure":"Gastroparesis Cardinal Symptom Index (GCSI) Score","time_frame":"Weeks 4 and 11 (end of periods)","description":"This is a Validated instrument for measuring symptom severity in patients with gastroparesis. This scoring is based on a Likert Scale from (0-5) with zero being no symptoms and five being very severe symptoms on 9 subscales, making the overall score range from 0-45. The higher the score, the more severe patient's symptoms.\r\nReference for GCSI: Revicki DA, REntz AM, Dubois D, et al. Development and validation of a patient-assessed gastroparesis symptoms severity measure: the Gastroparesis Cardinal Symptom Index. Ailment Pharm Ther 2003; 18: 141:50.\r\nBecause the difference is RX-B -RX A in one group and RX A -RX B in the other, the difference between these two estimates twice the effect size. Hence the Half is applied, as is standard in the two sample method for crossover studies."},{"outcome_type":"secondary","measure":"NDI Score","time_frame":"Weeks 4 and 11 (end of periods)","description":"Nepean Dyspepsia Index (NDI) is a measure of symptom status and quality of life in functional dyspepsia. This scale is scored using each subscale (Tension, interference with daily activities), Eating/drinking, Knowledge/control, work/study) and adding up the items for each of the five subscale score (2-10). Total score range would be 10-50).\r\nFor the NDI, a lower number is better meaning the symptom is not effecting quality of life and a higher score closer to 50 is worse meaning it is effecting patients quality of life.\r\nReference: Talley NJ, Verlinden M, Jones M. Quality of life in functional dyspepsia: responsiveness of the Nepean Dyspepsia Index and developement of a new 10-iten short form. Aliment Pharmacol Ther 2001: 15: 207-216.\r\nBecause the difference is RX-B -RX A in one group and RX A -RX B in the other, the difference between these two estimates twice the effect size. Hence the Half is applied, as is standard in the two sample method for crossover studies."},{"outcome_type":"secondary","measure":"TLAG (Time From Ingestion of Meal to Start of Gastric Emptying)","time_frame":"Weeks 4 and 11 (end of periods)","description":"This is defined as the time from ingestion of the meal to the beginning of the emptying process in minutes. Because the difference is RX-B -RX A in one group and RX A -RX B in the other, the difference between these two estimates twice the effect size. Hence the Half is applied, as is standard in the two sample method for crossover studies."},{"outcome_type":"secondary","measure":"Change in Time to 50% Gastric Emptying: Post Test Less Baseline Pooled Over Orderings","time_frame":"Baseline and end of treatment period","description":"Patients will be given a standardized meal enriched with a labeled material and the breath samples are then collected and analyzed. The estimated time to reaching 50% of the accumulated contents is recorded."},{"outcome_type":"secondary","measure":"Change in Time to 50% Emptying: Post Test Less Baseline Pooled Over Orderings","time_frame":"at baseline before initiation of the treatment and after completion of each treatment period.","description":"Patients will be given a standardized meal enriched with a labeled material and the breath samples are then collected and analyzed. The estimated time to reaching 50% of the accumulated contents is recorded."},{"outcome_type":"secondary","measure":"Gastroparesis Cardinal Symptom Index (GCSI) Score Change From Baseline to Post Treatment","time_frame":"Baseline and end of treatment period","description":"This is a Validated instrument for measuring symptom severity in patients with gastroparesis. This scoring is based on a Likert Scale from (0-5) with zero being no symptom and five being very severe symptoms on 9 subscales, making the overall score range from 0-45. The higher the score, the more severe patient's symptoms are. The scale is reported in the references. The change was calculated by measuring the end of treatment minus baseline GCSI score.\r\nNegative value reflects this change."},{"outcome_type":"secondary","measure":"Does GCSI Score Improve (Lower) on Treatment, Pooling the AZ Patients Over Their Treatment Periods? Endpoint is Difference in Post-test Less Baseline","time_frame":"Baseline and end of treatment period","description":"This is a Validated instrument for measuring symptom severity in patients with gastroparesis. This scoring is based on a Likert Scale from (0-5) with zero being no symptom and five being very severe symptoms on 9 subscales, making the overall score range from 0-45. The higher the score, the more severe patient's symptoms are. The scale is reported in the references.\r\nThis is a calculation taken with GCSI score at end of treatment minus baseline. Negative value reflects this change."}]}
{"nct_id":"NCT00820547","start_date":"2009-01-31","phase":"Phase 2","enrollment":100,"brief_title":"Efficacy and Tolerance Study of Bevacizumab in Her2- Inflammatory Breast Cancer Patients","official_title":"Phase II Study Evaluating the Efficacy and Tolerance of Bevacizumab (Avastin) in HER2- Inflammatory Breast Cancer","primary_completion_date":"2015-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2019-09-30","last_update":"2019-10-22","description":"RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab and combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving bevacizumab and radiation therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying giving bevacizumab together with chemotherapy before surgery and bevacizumab and radiation therapy after surgery to see how well it works in treating patients with inflammatory breast cancer.","other_id":"PACS09 UC-0140/0802","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        DISEASE CHARACTERISTICS:\r\n\r\n          -  Histologically confirmed inflammatory breast cancer, meeting 1 of the following\r\n             staging criteria:\r\n\r\n               -  T4d, any N (AJCC stage IIIB or IIIC)\r\n\r\n               -  Gustave-Roussy Institute (IGR) classification Poussee evolutirie (PEV; measures\r\n                  tumor growth over time) 2\r\n\r\n                    -  PEV 2: tumor with underlying breast tissue, especially skin, that is\r\n                       affected by subacute inflammation and edema involving <  of breast surface\r\n\r\n               -  IGR classification PEV 3\r\n\r\n                    -  PEV 3: acute or subacute inflammation and edema involving >  of breast\r\n                       surface\r\n\r\n               -  Biopsy-confirmed presence of tumor embolism in surface lymph nodes\r\n\r\n          -  HER2-negative (HER2 0 or 1+, or HER2 2+ by IHC if FISH-negative allowed)\r\n\r\n          -  No metastatic disease\r\n\r\n          -  No non-inflammatory breast cancer with edema, ulceration, or satellite skin nodules\r\n\r\n          -  No bilateral breast cancer\r\n\r\n          -  Hormone receptor status known\r\n\r\n        PATIENT CHARACTERISTICS:\r\n\r\n          -  Any menopausal status allowed\r\n\r\n          -  WHO performance status 0-2\r\n\r\n          -  Life expectancy 3 months\r\n\r\n          -  LVEF normal by ECHO\r\n\r\n          -  ANC >1.5 x 10^9/L\r\n\r\n          -  Platelet count >100 x 10^9/L\r\n\r\n          -  INR 1.5 (except for patients on prophylactic anticoagulants)\r\n\r\n          -  aPTT 1.5 times upper limit of normal (ULN)\r\n\r\n          -  Total bilirubin normal\r\n\r\n          -  SGOT and SGPT 1.25 times ULN\r\n\r\n          -  Alkaline phosphatase 2.5 times ULN\r\n\r\n          -  Creatinine clearance 60 mL/min\r\n\r\n          -  Proteinuria <2+ or 24-hour urine protein 1 g\r\n\r\n          -  No unhealed wound, stomach ulcer, or bone fracture\r\n\r\n          -  No history of thrombotic or hemorrhagic disorders\r\n\r\n          -  No significant cardiovascular disease including the following:\r\n\r\n               -  Cerebrovascular accident within the past 6 months\r\n\r\n               -  Unstable angina\r\n\r\n               -  Cardiac failure\r\n\r\n               -  Myocardial infarction\r\n\r\n               -  Arrhythmia requiring treatment\r\n\r\n          -  No uncontrolled hypertension (i.e., systolic BP >150 mm Hg and/or diastolic BP >100 mm\r\n             Hg)\r\n\r\n          -  No other active infection or serious illness that would preclude patient from\r\n             receiving study treatment\r\n\r\n          -  No hypersensitivity to any active products or excipients of study drugs\r\n\r\n          -  Not pregnant or nursing\r\n\r\n          -  Fertile patients must use effective contraception during and for 6 months after\r\n             completion of study treatment\r\n\r\n          -  No social or psychologic reasons that would prevent study compliance or follow-up\r\n\r\n          -  No patients who are incarcerated or on probation\r\n\r\n        PRIOR CONCURRENT THERAPY:\r\n\r\n          -  No prior chemotherapy, radiotherapy, or hormonal therapy for this disease\r\n\r\n          -  More than 4 weeks since prior surgery (diagnostic biopsy or installation of implant\r\n             allowed)\r\n\r\n          -  More than 10 days since prior chronic non-inflammatory steroids (e.g., acetylsalicylic\r\n             acid >325 mg/day) or platelet anticoagulation treatment (e.g., dipyridamole,\r\n             ticlopidine, clodiprogel, cilostazol)\r\n\r\n          -  More than 10 days since prior oral or parenteral anticoagulant or thrombolytic drugs\r\n             (preventative thrombolytic drugs allowed)\r\n\r\n          -  No concurrent participation in another experimental clinical trial\r\n      ","sponsor":"UNICANCER","sponsor_type":"Other","conditions":"Breast Cancer","interventions":[{"intervention_type":"Biological","name":"Biological: bevacizumab","description":"During neoadjuvant phase: 15 mg/kg, d1 q3w, 8 cycles During adjuvant phase:15 mg/kg, d1 q3w, 10 cycles"},{"intervention_type":"Drug","name":"Drug: cyclophosphamide","description":"Neoadjuvant: 500 mg/m2 d1 q3w, 4 cycles"},{"intervention_type":"Drug","name":"Drug: docetaxel","description":"Neoadjuvant: 100 mg/m2 q3w, 4 cycles"},{"intervention_type":"Drug","name":"Drug: epirubicin hydrochloride","description":"Neoadjuvant: 100 mg/m2, d1 q3w, 4 cycles"},{"intervention_type":"Drug","name":"Drug: fluorouracil","description":"Neoadjuvant: 500 mg/m2, d1 q3w, 4 cycles"}],"outcomes":[{"outcome_type":"primary","measure":"Complete histologic response rate","time_frame":"Post surgery"},{"outcome_type":"secondary","measure":"Progression-free survival","time_frame":"3 and 5 years"},{"outcome_type":"secondary","measure":"Overall survival","time_frame":"3 and 5 years"},{"outcome_type":"secondary","measure":"Toxicity as assessed by CTCAE v3.0","time_frame":"3 and 5 years"},{"outcome_type":"secondary","measure":"Predictive factors of response to bevacizumab","time_frame":"3 and 5 years"},{"outcome_type":"secondary","measure":"Circulating peripheral cells (circulating endothelial and tumor cells): correlation of initial rate and association with histological response after surgery","time_frame":"Post-surgery"},{"outcome_type":"secondary","measure":"Genomic and proteomic analyses and correlation with histologic response","time_frame":"Post surgery"}]}
{"nct_id":"NCT00571376","start_date":"2009-01-31","enrollment":218766,"brief_title":"Evaluating the Impact on Quality and Costs of Regional Clinical Data Exchange Programs in New York State","official_title":"Evaluating the Impact on Quality and Costs of Regional Clinical Data Exchange Programs in New York State","primary_completion_date":"2010-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2010-12-31","last_update":"2017-02-23","description":"The purpose of this study is to measure the financial effects of health information technology and health information exchange in regional health information organizations in New York State.","other_id":"20060550","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","population":"Patients and health care providers in the Rochester, NY community","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients and health care providers participating in regional health information\r\n             organizations or their affiliate institutions.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  None\r\n      ","sponsor":"Weill Medical College of Cornell University","sponsor_type":"Other","conditions":"Quality of Health Care|Health Care Costs","interventions":[{"intervention_type":"Other","name":"Other: Health information technology and exchange","description":"Health information technology includes electronic health records, electronic prescribing, and electronic results notification and/or viewers. Health information exchange includes use of central repositories of data and peer-to-peer models."}],"outcomes":[{"outcome_type":"primary","measure":"Hospital admissions","time_frame":"2 years"},{"outcome_type":"primary","measure":"Hospital re-admissions","time_frame":"2 years"},{"outcome_type":"primary","measure":"Repeat medical imaging","time_frame":"2 years"},{"outcome_type":"secondary","measure":"Usage of health information technology and health information exchange","time_frame":"2 years"},{"outcome_type":"secondary","measure":"Changes in health care quality","time_frame":"2 years"},{"outcome_type":"secondary","measure":"Changes in patient safety","time_frame":"2 years"},{"outcome_type":"secondary","measure":"Changes in health care efficiency","time_frame":"2 years"}]}
{"nct_id":"NCT02113462","start_date":"2009-01-31","enrollment":197,"brief_title":"Triglyceride/High-density Lipoprotein Cholesterol Ratio in Chronic Kidney Disease","official_title":"The Prospective Cohort Study to Investigate the Role of Plasma Triglyceride/High-Density Lipoprotein Cholesterol Ratio To Predict Cardiovascular Outcomes in Chronic Kidney Disease.","primary_completion_date":"2013-01-31","study_type":"Observational","rec_status":"Completed","completion_date":"2013-01-31","last_update":"2014-04-14","description":"The Triglycerides (TG) to High Density Lipoprotein Cholesterol (HDL-C) ratio is a feature of insulin resistance and an independent predictor of cardiovascular risk. The investigators aimed to evaluate the relationship between TG/HDL-C ratio and the endothelial functions in patients with CKD.","other_id":"GSM-012014","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":20,"maximum_age":80,"population":"renal unit","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  patients with chronic kidney disease\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  taking drugs that may influence endothelial function\r\n\r\n          -  acute infections\r\n      ","sponsor":"Gulhane School of Medicine","sponsor_type":"Other","conditions":"Chronic Kidney Disease","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"All cause mortality","time_frame":"30 months","description":"The COX analysis was performed in order to establish which covariates were independent predictors of cardiovascular outcomes. Kaplan Meier survival curves are generated to show the impact of the TG/HDL ratio on the cumulative survival of the cohort. The predictive power of the median TG/HDL ratio in each CKD stage for all-cause mortality and cardiovascular events are measured."},{"outcome_type":"primary","measure":"Endothelial functions assessed by flow mediated dilatation and serum ADMA measurement","time_frame":"Once in recruitment","description":"The predictive role of TG/HDL ratio on endothelial functions (ADMA and flow mediated dilatation) is determined by univariate and multivariate analyses."}]}
{"nct_id":"NCT01629433","start_date":"2009-01-31","enrollment":25,"brief_title":"Onabotulinumtoxina Intradetrusorial Injections and NGF Expression","official_title":"PHASE IV STUDY ON THE EFFECTS OF ONABOTULINUMTOXINA INTRADETRUSORIAL INJECTIONS ON BLADDER EXPRESSION OF NGF, TRKA, P75 AND TRPV1 IN PATIENTS WITH DETRUSOR OVERACTIVITY","primary_completion_date":"2011-06-30","study_type":"Observational","rec_status":"Completed","completion_date":"2012-03-31","last_update":"2012-06-27","description":"In the last years, botulinum toxin type A (onab/A) has been increasingly used as a treatment option for overactive bladder symptoms in patients affected by either neurogenic and idiopathic detrusor overactivity (DO). How onab/A injected into the detrusor muscle improves overactive bladder symptoms in neurologic patients has been only partially investigated.Some evidence suggested that the neurotoxin probably reduces detrusor muscle contraction blocking detrusor muscle cholinergic innervation. However, recent experimental observations indicated that onab/A determines more complex effects on bladder activity acting on afferent innervations as well as on the efferent one. Only few experimental studies have investigated the activity of onab/A on bladder afferent nervous transmission. Experimental studies in animals showed that Nerve Growth Factor (NGF) elicits increased sensation, urgency and DO. Although there are some evidence on the ability of onab/A to improve DO and to reduce bladder and urinary content of NGF, how onab/A influences NGF expression and the expression of TrKa, p75 and TRPV1 receptors is still unclear. The hypothesis is that onab/A reduces NGF bladder tissue levels and in the same time it modulates the gene expression of NGF associated receptors (TrkA, p75 and TRPV1).","other_id":"onabotulinumatoxin and NGF","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":80,"population":"We consecutively enrolled 18 patients with neurogenic DO (8 patients with spinal cord\r\n        injury: 7 men and 1 women, mean age: 462 yrs, disease duration 6.251 yrs; 10 patients\r\n        with suprapontine bilateral lesions: 4 men and 6 women, mean age: 554 yrs, disease\r\n        duration 6.61.49 yrs ) and 7 with idiopathic DO (3 men and 4 female, mean age: 535 yrs,\r\n        disease duration 7.11.53 yrs). All the patients had overactive bladder (OAB) symptoms and\r\n        DO refractory to conventional anticholinergics (at least 3 antimuscarinic agents --\r\n        tolterodine, oxybutynin and solifenacin -- each taken for at least 1 month).\r\n        Anticholinergics were discontinued one month before entry into the study.","criteria":"\n        Inclusion Criteria:\r\n\r\n        Patients affected by refractory overactive bladder (OAB) symptoms and detrusor overactivity\r\n        (idiopathic and neurogenic DO) refractory to conventional anticholinergics (at least 3\r\n        antimuscarinic agents -- tolterodine, oxybutynin and solifenacin -- each taken for at least\r\n        1 month).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  OAB symptoms due to bladder outlet obstruction because of urogenital prolapse in\r\n             females and benign prostatic hyperplasia in males,\r\n\r\n          -  recurrent urinary tract infections,\r\n\r\n          -  cognitive impairment,\r\n\r\n          -  pregnancy,\r\n\r\n          -  anticoagulant therapy,\r\n\r\n          -  psychoactive agents modulating bladder function (venlafaxine, amitriptyline),\r\n             aminoglycosides, and other drugs thought to interfere with bladder function\r\n      ","sponsor":"University Of Perugia","sponsor_type":"Other","conditions":"Overactive Detrusor|Detrusor Hyperreflexia of Bladder","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"to investigate onab/A- induced changes on gene expression of NGF, TRPV1, TrkA and p75 in bladder wall tissue of patients with neurogenic and idiopathic DO.","description":"All patients underwent cystoscopy with bladder wall biopsy specimens. After undergoing cystoscopy with bladder sampling patients underwent onab/A intradetrusorial injections. Patients were injected with 100 or 300 onab/A U according to the type of DO. Urodynamic studies and cystoscopies with bladder sampling were repeated 1 month later. NGF and neuroreceptors (TrkA, TRPV1, p75)gene expression have been measured with Real Time Polymerase Chain reaction. NGF bladder tissue content (protein) has been added into evaluation and measured with ELISA."},{"outcome_type":"secondary","measure":"To evaluate urodynamic improvements","description":"Improvement in uninhibited detrusor contractions' maximum pressure (cmh20)."},{"outcome_type":"secondary","measure":"To investigate urodynamic improvements.","description":"Improvement in uninhibited detrusor contractions' first volume (ml)"},{"outcome_type":"secondary","measure":"To investigate urodynamic improvements.","description":"Improvement in maximum cystometric capacity (ml)."}]}
{"nct_id":"NCT00826566","start_date":"2009-01-31","phase":"N/A","enrollment":0,"brief_title":"Anti-inflammatory Effects of Caffeine in Chronic Obstructive Pulmonary Disease (COPD) Subjects","official_title":"Pilot Study to Investigate the Anti-inflammatory Effects of Caffeine in Subjects With Chronic Obstructive Pulmonary Disease (COPD)","primary_completion_date":"2009-06-30","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2009-09-30","last_update":"2015-09-23","description":"Nowadays it has become evident that a chronic systemic inflammation is present in patients suffering from chronic obstructive pulmonary disease (COPD). The role of the nuclear enzyme poly(adenosine diphosphate-ribose)polymerase (PARP) as a key mediator within these systemic inflammatory processes as well as in COPD associated exercise intolerance and muscle weakness could recently been identified. The attenuating effect of dietary ingredients with PARP inhibiting activity on systemic inflammation was supported by data from in vitro and in vivo studies, from other groups as well as from our own lab. We identified several caffeine metabolites as potent inhibitors of the most abundant PARP-isoform PARP-1 in-vitro, in animal models as well as in ex-vivo experiments with whole blood from COPD patients. However, clinical data with respect to their anti-inflammatory effects in COPD patients are currently not available for none of these substances. Therefore, the current clinical pilot study is intended to establish for the first time clinical data (proof of principle) on the anti-inflammatory potential of caffeine metabolites.","other_id":"STW6041","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Prevention","masking_description":"Quadruple","sampling_method":"","gender":"Male","minimum_age":40,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  COPD GOLD stage II (50%  FEV1< 80%)\r\n\r\n          -  CRP plasma levels  3 mg/l\r\n\r\n          -  BMI > 20 kg/m2 and < 30 kg/m2\r\n\r\n          -  Diastolic blood pressure (DBP)=60-90 mmHg, Systolic blood pressure (SBP)=100 150 mmHg\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Physical and/or mental disease or major surgery in the present or the past that might\r\n             limit participation in or completion of the study\r\n\r\n          -  Reported current or previous metabolic (e.g. diabetes), cardiovascular and/or renal\r\n             diseases\r\n\r\n          -  Known presence of a carcinoma\r\n\r\n          -  Acute and/or chronic inflammatory condition such as arthritis, arthrosis, chronic\r\n             colitis, etc. during three months before entry of the study\r\n\r\n          -  Respiratory tract infection or exacerbation of COPD for at least 8 weeks prior to the\r\n             start of the study\r\n\r\n          -  Change in treatment regime of the COPD subjects for at least 8 weeks prior to the\r\n             start of the study\r\n\r\n          -  Use of laxatives, anti-diarrhoeal drugs and any other medication that can influence\r\n             the uptake of the investigational products and/or influence their metabolism during\r\n             the trial\r\n\r\n          -  During the month prior to the start of the study and during the study the use of\r\n             antibiotics and/or local and systemic steroidal (glucocorticoids) and non-steroidal\r\n             anti-inflammatory drugs (NSAID)\r\n\r\n          -  Abnormal constant dietary eating habits and a coffee consumption of less than 3 cups\r\n             per day (i.e. a usual daily intake of <400 mg caffeine).\r\n      ","sponsor":"Maastricht University Medical Center","sponsor_type":"Other","conditions":"Chronic Obstructive Pulmonary Disease","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Caffeine","description":"2 times 250 mg caffeine per day"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: placebo","description":"2 times 250 mg per day"}],"outcomes":[{"outcome_type":"primary","measure":"Plasma concentrations of C-reactive protein (CRP) and the cytokines TNF-a, IL-6, IL-8 and IL-10.","time_frame":"at the start and at the end of the intervention periods"},{"outcome_type":"secondary","measure":"Activation of poly-(ADP-ribose) polymerase (PARP)-1 activation and DNA repair in peripheral lymphocytes","time_frame":"at the start and the end of the intervention periods"},{"outcome_type":"secondary","measure":"Oxidative stress markers in plasma such as PGF2alpha","time_frame":"at the start and the end of the intervention periods"},{"outcome_type":"secondary","measure":"Plasma concentrations of caffeine and metabolites","time_frame":"at the start and the end of the interventions"},{"outcome_type":"secondary","measure":"Gene transcription levels of cytokines, redox enzymes and other proteins involved in inflammatory and oxidative stress response","time_frame":"at the start and the end of the interventions"},{"outcome_type":"secondary","measure":"Cytokine concentrations in whole blood after ex vivo stimulation with LPS","time_frame":"at the start and the end of the interventions"}]}
{"nct_id":"NCT01841541","start_date":"2009-01-31","phase":"N/A","enrollment":380,"brief_title":"The Impact of Involving Informal Health Providers for Tuberculosis Control in Sudan","official_title":"Triage Plus for TB: Improving Community-Based Provision for TB in Africa. The Impact of Involving Informal Health Providers for Tuberculosis Control in Sudan","primary_completion_date":"2012-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-04-30","last_update":"2013-04-26","description":"Training and engaging of unpaid informal providers (such as tea-sellers, women's groups, youth clubs, small traders and religious groups) from poorer localities in TB disease recognition, referral and community awareness raising will increase the access of TB patients to formal health facilities and decrease their delay in initiating TB treatment.","other_id":"11.03RS","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":14,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Access point for health seeking by the poor and vulnerable\r\n\r\n          -  Active and well known in community\r\n\r\n          -  Intervention activities can be confined to intervention area\r\n\r\n          -  Based in community/locality\r\n\r\n          -  Longevity; long standing\r\n\r\n          -  Present in control and intervention areas\r\n\r\n          -  Able and willing to complete the training to be Triage-Plus providers (ie giving\r\n             formal consent)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Formal health providers, e.g. clinics, labs, hospitals (MOH, NGO or private)\r\n\r\n          -  Internationally funded organizations, e.g. international NGOs\r\n\r\n          -  Civil servants e.g. teachers\r\n      ","sponsor":"Liverpool School of Tropical Medicine","sponsor_type":"Other","conditions":"Tuberculosis","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Referral of presumptive of TB cases by informal providers","description":"Training of informal providers to effectively refer TB suspects in the community to the primary health care system"}],"outcomes":[{"outcome_type":"primary","measure":"Total number of TB patients registered and start receiving treatment in formal health care facilities","time_frame":"12 months","description":"This will be measured by comparing Data from routine patients registered in formal TB management units in the intervention arm and compare it with the same routine data from the control arm. similar data for the previous year will undergo the same comparison as time control for both arms"}]}
{"nct_id":"NCT00855127","start_date":"2009-01-31","enrollment":0,"brief_title":"New Urine and Blood Markers for Acute Kidney Injury in Liver Transplant Patients","official_title":"Early Biomarkers of Acute Kidney Injury in Liver Transplant Patients","primary_completion_date":"2013-06-30","study_type":"Observational","rec_status":"Withdrawn","completion_date":"2013-07-31","last_update":"2015-06-01","description":"The purpose of this study is to find new blood and urine tests that detect acute kidney injury earlier than our current blood tests in patients receiving a liver transplant.","other_id":"08-0769","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":90,"population":"All patients presenting to the University of Colorado Hospital or the University of\r\n        Washington Medical Center for a liver transplant operation","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  First time liver transplant recipient\r\n\r\n          -  Cadaveric or living donor livers\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Unconscious patients or patients who cannot give consent\r\n\r\n          -  Pregnant women\r\n\r\n          -  Prisoners\r\n\r\n          -  Patients receiving dialysis before or during liver transplant operation\r\n\r\n          -  Patients receiving simultaneous liver-kidney transplants\r\n      ","sponsor":"University of Colorado, Denver","sponsor_type":"Other","conditions":"Renal Insufficiency, Acute","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Development of acute kidney injury as defined by a 50% increase in serum creatinine","time_frame":"Within 2 to 5 days of liver transplant that is sustained for at least 24 hours"},{"outcome_type":"secondary","measure":"Development of severe acute kidney injury, as defined as a doubling of serum creatinine","time_frame":"Within 2-5 days of transplant that is sustained for at least 24 hours"},{"outcome_type":"secondary","measure":"The need for renal replacement therapy","time_frame":"After liver transplant operation to discharge"},{"outcome_type":"secondary","measure":"All cause mortality","time_frame":"After liver transplant operation to discharge"}]}
{"nct_id":"NCT01073527","start_date":"2009-01-31","phase":"N/A","enrollment":41,"brief_title":"Hypertonic Saline as Add on Therapy in Preschool Children With Acute Wheezing Attack.","official_title":"Interventional Study: Hypertonic Saline as Add on Treatment to the Usual Therapy for Preschool Children With Acute \"Asthmatic\" Attack Presenting to the ER: A Double Blind Control Study","primary_completion_date":"2011-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-07-31","last_update":"2011-08-09","description":"To investigate the efficacy of adding Inhaled Hypertonic Saline treatment (HS) for 1-6 year old children with \"asthmatic\" attack presenting to Emergency Department (ED). Background: In 1-6 year old children, the most common causes of acute exacerbations of asthma requiring urgent medical care are viral respiratory infections. Most of these children are not atopic and often do not respond very well to bronchodilators and steroids. Thus novel treatments are needed. HS is considered an effective and safe treatment for infants with acute viral bronchiolitis (Cochrane 2008). HS acts in the airways in several mechanisms: HS re-hydrates secretions and improving mucus rheology, reduce edema of the airway wall by absorbing water from the mucosa and submucosa, causes sputum induction and cough, which can help to clear the sputum out of the bronchi, stimulates cilial beat via the release of prostaglandin E2, breaks the ionic bonds within the mucus gel, thereby lowering the viscosity and elasticity of the mucus secretion. It is estimated that all the above HS responding elements may play a role in this viral induce wheezing. The above mentioned theoretical benefits provide the rationale for the possible treatment of viral induced acute wheezing (\"asthma\") attack with nebulized HS in young pre-school children presenting to the Pediatric Emergency Unit with acute (mostly viral induced) wheezing. Therefore, the purpose of the present study is to 1. Investigate the addition of frequently nebulized 5% HS/albuterol combination to standard therapy of acute asthmatic episodes presenting to the emergency department (ED) in preschool children in a prospective, randomized, double-blind, controlled fashion.","other_id":"1038","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":1,"maximum_age":6,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Children, age: 1-6 years old\r\n\r\n          -  Presenting to the ED with acute wheezing episode\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any chronic (lung, cardiac, immunologic, neurologic) disease\r\n      ","sponsor":"Wolfson Medical Center","sponsor_type":"Other","conditions":"Asthma","interventions":[{"intervention_type":"Drug","name":"Drug: hypertonic saline-salbutamol combination","description":"hypertonic saline 5% with 0.5cc salbutamol"},{"intervention_type":"Drug","name":"Drug: Normal saline-salbutamol combination","description":"normal saline - 4cc with salbutamol 0.5cc"}],"outcomes":[{"outcome_type":"primary","measure":"shortening length of stay (LOS)","time_frame":"From admision to ready to discharge."},{"outcome_type":"secondary","measure":"Hospitalization rate","time_frame":"From presenting to ED until admission to hospital"},{"outcome_type":"secondary","measure":"Improvement in clinical score (CS)","time_frame":"Post inhalations on presentation to the ED and daily during hospitalization"}]}
{"nct_id":"NCT00817323","start_date":"2009-01-31","phase":"Phase 3","enrollment":0,"brief_title":"What is the Antidepressant Mechanism of Action of Quetiapine in Bipolar Depression?","official_title":"What is the Antidepressant Mechanism of Action of Quetiapine in Bipolar Depression? Evidence From Selective Neurotransmitter Depletion Studies","primary_completion_date":"2013-12-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2013-12-31","last_update":"2014-07-08","description":"PURPOSE The purpose of this study is to elucidate whether quetiapine fumurate (Seroquel) exerts its antidepressant activity in bipolar disorder through altering either serotonergic or catecholinergic activity. HYPOTHESIS By depleting either serotonin or catecholamines in successfully treated bipolar patients, relapse will be induced and reveal which neurotransmitters are effected when receiving normal treatment JUSTIFICATION While the exact mechanism of action of the classical antidepressants is not fully understood, strong evidence implicating serotonin and noradrenalin to be necessary (albeit insufficient) for the resolution of depression comes from neurotransmitter depletion studies. This biological evidence for each of these two neurotransmitters come from study paradigms in which the neurotransmitter (or its precursor) are selectively and effectively depleted from patients who have responded to antidepressants which either work through enhancing serotonin (for example, SRI antidepressants) or catecholamines (such as secondary amine tricyclics, Reboxetine, etc.). It has been shown, and replicated, that patients that respond to serotonin enhancing drugs precipitously and dramatically relapse when given a diet (often in the form of a milkshake) which is void of tryptophan, the precursor of serotonin. This diet often contains other long-chain amino acids to prevent any residual tryptophan in the system from entering the CNS. These patients who have then relapsed on the tryptophan-free diet have their tryptophan repleted and their mood improves often over a very short time frame (for example, five hours). When this technique is performed on patients responding to catecholamine-enhancing drugs there is no significant clinical effect. A similar approach can be taken with patients who respond to noradrelanine-enhancing drugs. Specifically, their catecholamine stores can be depleted by using dietary tyrosine. This reduces the synthesis of catecholamines and dopamine thus depleting pre-synaptic noradrenaline. For patients who responded to noradrenaline-enhancing drugs, this results in a relapse in terms of depressive symptomatology. When this dietary tyrosine strategy is applied to serotonin responders, there is no significant clinical effect.","other_id":"H07-02995","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":19,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Provision of written informed consent\r\n\r\n          2. A diagnosis of Bipolar Disorder, depressed phase by Diagnostic and Statistical Manual\r\n             of Mental Disorders- Fourth Edition (DSM-IV)\r\n\r\n          3. Females or males aged 19 to 65 years.\r\n\r\n          4. Female patients of childbearing potential must be using a reliable method of\r\n             contraception and have a negative urine human chorionic gonadotropin (HCG) test at\r\n             enrolment, and be in follicular phase of menstrual cycle for duration of depletion\r\n             portion of study.\r\n\r\n          5. Able to understand and comply with the requirements of the study\r\n\r\n          6. Presently taking therapeutic doses of Quetiapine\r\n\r\n          7. In remission, as determined by attending clinician by scoring 7 or less on the HAM-D\r\n             (17-item) at time of screening.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Pregnancy or lactation\r\n\r\n          2. Any DSM-IV Axis I disorder not defined in the inclusion criteria\r\n\r\n          3. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or\r\n             a danger to self or others\r\n\r\n          4. Known intolerance or lack of response to quetiapine fumarate, as judged by the\r\n             investigator\r\n\r\n          5. Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding\r\n             enrolment including but not limited to: ketoconazole, itraconazole, fluconazole,\r\n             erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir,\r\n             fluvoxamine and saquinavir\r\n\r\n          6. Use of any of the following cytochrome P450 inducers in the 14 days preceding\r\n             enrolment including but not limited to: phenytoin, carbamazepine, barbiturates,\r\n             rifampin, St. John's Wort, and glucocorticoids\r\n\r\n          7. Administration of a depot antipsychotic injection within one dosing interval (for the\r\n             depot) before randomisation\r\n\r\n          8. Substance or alcohol dependence at enrolment (including caffeine and nicotine\r\n             dependence; except dependence in full remission), as defined by DSM-IV criteria\r\n\r\n          9. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV\r\n             criteria within 6 months prior to enrolment\r\n\r\n         10. Medical conditions that would affect absorption, distribution, metabolism, or\r\n             excretion of study treatment\r\n\r\n         11. Unstable or inadequately treated medical illness (e.g. congestive heart failure,\r\n             angina pectoris, hypertension) as judged by the investigator\r\n\r\n         12. Involvement in the planning and conduct of the study\r\n\r\n         13. Previous enrolment or randomisation of treatment in the present study.\r\n\r\n         14. Participation in another drug trial within 4 weeks prior enrolment into this study or\r\n             longer in accordance with local requirements\r\n\r\n         15. A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:\r\n\r\n               -  Unstable DM defined as enrolment glycosylated hemoglobin (HbA1c) >8.5%.\r\n\r\n               -  Admitted to hospital for treatment of DM or DM related illness in past 12 weeks.\r\n\r\n               -  Not under physician care for DM\r\n\r\n               -  Physician responsible for patient's DM care has not indicated that patient's DM\r\n                  is controlled.\r\n\r\n               -  Physician responsible for patient's DM care has not approved patient's\r\n                  participation in the study\r\n\r\n               -  Has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4\r\n                  weeks prior to randomisation. For thiazolidinediones (glitazones) this period\r\n                  should not be less than 8 Weeks.\r\n\r\n               -  Taking insulin whose daily dose on one occasion in the past 4 weeks has been more\r\n                  than 10% above or below their mean dose in the preceding 4 weeks Note: If a\r\n                  diabetic patient meets one of these criteria, the patient is to be excluded even\r\n                  if the treating physician believes that the patient is stable and can participate\r\n                  in the study.\r\n\r\n         16. An absolute neutrophil count (ANC) of 1.5 x 109 per liter\r\n\r\n         17. Currently taking any other antipsychotic, aside from Quetiapine.\r\n\r\n         18. Currently taking any antidepressant compounds, or in 8 weeks prior to enrolment.\r\n\r\n         19. Medical condition or known dietary sensitivity to depletion measures.\r\n      ","sponsor":"University of British Columbia","sponsor_type":"Other","conditions":"Bipolar Depression","interventions":[{"intervention_type":"Procedure","name":"Procedure: Dietary amino-acid depletion","description":"See detailed description"}],"outcomes":[{"outcome_type":"primary","measure":"To determine if a given depletion treatment induces relapse, measured as the mean HAM-D 17-item score of each group. A HAM-D score of 12 points or higher will be defined as relapse, measured 24-, 48- and 96-hours post-depletion.","time_frame":"4 days"},{"outcome_type":"secondary","measure":"Maximum change between each VAS item; change in HAM-D score; correlation of change in plasma tryptophan and catecholamine levels; correlation of change in plasma amino acid levels from baseline to 24 hours post-depletion.","time_frame":"4 days"}]}
{"nct_id":"NCT00950781","start_date":"2009-01-31","enrollment":45,"brief_title":"Cortisol Levels on Menopausal Symptoms - Ancillary (Addendum) Study to Protocol 16997","official_title":"Cortisol Levels on Menopausal Vasomotor Symptoms - an Ancillary (Addendum) Study to the \"Impact of Traditional Acupuncture on Menopausal Vasomotor Symptoms, Psychological Stress and the Hypothalamic Pituitary Adrenal (HPA) - Sympathetic Nervous System (SNS) Axis: A Randomized, Controlled Trial\"","primary_completion_date":"2010-02-28","study_type":"Observational","rec_status":"Completed","completion_date":"2010-02-28","last_update":"2019-06-07","description":"This is an ancillary study to Protocol 16997 to examine the stress hormone level in women with menopausal symptoms. This ancillary project will collect additional data from the 45 subjects enrolled in Protocol 16997 (no subjects have enrolled in Protocol 16997 so far). This study protocol differs from the main protocol (16997) because it will include an ACTH (Hormone) Stimulation Test which will assess the functioning of stress response in the subjects at entry and exit. Subjects will undergo the ACTH test for this ancillary protocol in the morning when they complete 24-hour urine collection for Protocol 16997. The ACTH (Hormone) Stimulation Test will not be done in the main protocol 16997. During the ACTH test an IV will be placed in subjects arms, 25mL of blood will be drawn at -30 minutes and 6mL of blood will be drawn at -15 minutes and 0 minutes respectively. Following, 0.25mg of ACTH will be injected intravenous over 60 seconds, and a final 12mL of blood will be drawn 60 minutes later. That is, a total of 50mL of blood will be drawn to test serum blood hormone levels from the subjects during the ACTH (Hormone) Stimulation Test. The 24 hour cortisol data collected in the main protocol 16997 will be used for this study analysis. When subjects are consented for Protocol 16997, they will also be consented for this ancillary study. In addition to the consent visit, subjects will have two study specific visits (entry and exit) for this ancillary study. The PI will schedule the specific visits for this study to be in conjunction with those scheduled for Protocol 16997. There is no collaborations with other sites in the ancillary study.","other_id":"IRB# 17569","observational_model":"Other","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"Female","minimum_age":40,"maximum_age":70,"population":"Menopausal women","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Women with menopausal VMS bothersome enough to warrant treatment;\r\n\r\n          2. Minimum of 7 hot flashes per day (on average);\r\n\r\n          3. Age limits: women ages 40-70 who have had at least one missed menstrual cycle or have\r\n             undergone spontaneous menopause, women of any age who have medically induced\r\n             menopause, women of any age who have had oophorectomy;\r\n\r\n          4. Informed written consent;\r\n\r\n          5. Ability to follow treatment protocols.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Exclusion Criteria (cohort)\r\n\r\n          1. Concomitant illness with reasonable likelihood of limiting survival to less than one\r\n             year;\r\n\r\n          2. Current substance abuse (alcohol or drug);\r\n\r\n          3. Pregnancy known, suspected or planned in next year.\r\n\r\n        Exclusion Criteria (TA intervention)\r\n\r\n          1. Other concomitant menopause treatment;\r\n\r\n          2. Participating in acupuncture treatment or formal psychological stress management\r\n             program within the last year;\r\n\r\n          3. Participating in another treatment for VMS, unless willing to stop it 4 weeks in\r\n             advance of participation;\r\n\r\n          4. HIV infection, chronic or active hepatitis or other blood-borne illness.\r\n      ","sponsor":"Cedars-Sinai Medical Center","sponsor_type":"Other","conditions":"Menopause","interventions":[{"intervention_type":"Procedure","name":"Procedure: ACTH","description":"During the ACTH test an IV will be placed in subjects arms, 25mL of blood will be drawn at -30 minutes and 6mL of blood will be drawn at -15 minutes and 0 minutes respectively. Following, 0.25mg of ACTH will be injected intravenous over 60 seconds, and a final 12mL of blood will be drawn 60 minutes later. That is, a total of 50mL of blood will be drawn to test serum blood hormone levels from the subjects during the ACTH (Hormone) Stimulation Test."}],"outcomes":[{"outcome_type":"primary","measure":"circulation at baseline and after acute ACTH stimulation","time_frame":"2 hours"},{"outcome_type":"secondary","measure":"urine collection of menopausal women with VMS pre and post treatment","time_frame":"24 hours"}]}
{"nct_id":"NCT04598373","start_date":"2009-01-31","enrollment":25000,"brief_title":"Effects of Interdisciplinary Treatment on Sickness Absence in Patients With Chronic Pain","official_title":"Effects of Interdisciplinary Treatment on Sickness Absence in Patients With Chronic Pain","primary_completion_date":"2016-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2016-12-31","last_update":"2020-10-22","description":"Chronic pain is a globally prevalent condition that causes enormous social costs; largely due to sickness absence. A common intervention for patients with chronic pain problems is interdisciplinary treatment (IDT), which consists of a combination of physical exercise, cognitive behavioural therapy and work training coordinated in an interdisciplinary team. Based on data from Swedish National Registers, this study evaluates the effects of IDT on sickness absence.","other_id":"Dalarna University","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":60,"population":"Patients that visited a Swedish SQRP-affiliated IDT specialist clinic.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  IDT startyear: 2009-2016\r\n\r\n          -  Age 18-60 yeras\r\n\r\n          -  Pain duration of minimum 90 days\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Cancer in the previous 5 years\r\n\r\n          -  An IDT assessment in the previous 2 years\r\n\r\n          -  Full or partial disability pension in the year preceding the IDT assessment\r\n      ","sponsor":"Dalarna University","sponsor_type":"Other","conditions":"Chronic Pain","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: interdisciplinary treatment","description":"Interdisciplinary treatment (IDT) distinguishes itself as an interdisciplinary-coordinated (e.g., physician, occupational therapist, physiotherapist, and psychologist) intervention using a bio-psycho-social view of chronic pain. The MMR continues over a lengthy period with a common goal and generally includes patient education, supervised physical activity, simulated work training, and cognitive behavioural therapy (CBT). The exact composition of these MMR components depends on initial evaluations of the patients health status and furhter follow-up testing. The MMR interventional components can act independently and interdependently, resulting in combined effects due to known and unknown mechanisms; the effects are intended to be greater than the sum of its components."}],"outcomes":[{"outcome_type":"primary","measure":"Sickness absence","time_frame":"5 years","description":"Length of stay per sickness absence state: no sickness absence, sick leave, disability pension"}]}
{"nct_id":"NCT02119013","start_date":"2009-01-31","phase":"Phase 2/Phase 3","enrollment":35,"brief_title":"Effects of Somatostatin on ADPKD Heart","official_title":"EFFECT OF SOMATOSTTIN ON EARLY DIASTOLIC LEFT VENTRICULAR FUNCTION IN AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE: A MATCHED-COHORT, SPECKLE-TRACKING ECHOCARDIOGRAPHIC STUDY","primary_completion_date":"2013-09-30","study_type":"Interventional","rec_status":"Completed","last_update":"2014-04-21","description":"Autosomal dominant polycystic kidney disease (ADPKD) is associated with early onset hypertension and left ventricular (LV) hypertrophy. Since LV hypertrophy is associated with LV diastolic function impairment, we aimed to assess the changes over time of LV diastolic function in ADPKD patients and whether they were affected by the treatment with the somatostatin analogue, octreotide. 35 ADPKD patients (14 males) aged 348 years (mean glomerular filtration rate 8226 mL/min/1.73m2) were randomly assigned to 36 month treatment with placebo (n=18) or octreotide (n=17). Clinical and echocardiography parameters were evaluated at baseline and study end. LV mass (M) and ejection fraction (EF) were calculated according to Devereux formula and biplane Simpson's algorithm, respectively. LV filling was assessed by mitral and pulmonary vein flow velocity curves and mitral annulus early diastolic velocity peak (Ea) by tissue Doppler imaging.","other_id":"ADPKD-heart","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  diagnosis of autosomal dominant polycystic kidney disease\r\n\r\n          -  glomerular filtration rate grater than 40 ml/min\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  diabetes mellitus\r\n\r\n          -  proteinuria greater than 1 g/24 hours\r\n\r\n          -  significant glomerular disease\r\n\r\n          -  urinary tract lithiasis and infections\r\n\r\n          -  symptomatic gallstones\r\n\r\n          -  biliary sludge\r\n\r\n          -  cancer\r\n\r\n          -  pregnant women\r\n\r\n          -  lactanting women\r\n      ","sponsor":"Federico II University","sponsor_type":"Other","conditions":"Autosomal Dominant Polycystic Kidney Disease|Glomerular Filtration Rate > 40 ml/Min","interventions":[{"intervention_type":"Drug","name":"Drug: Octeotride"},{"intervention_type":"Drug","name":"Drug: Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"EFFECT ON LEFT VENTRICULAR DYASTOLIC FUNCTION","time_frame":"3 years","description":"To assess the changes over time of left ventricular dyastolic function in ADPKD patients and whether they were affected by the treatment with the somatostatin analogue, octreotide"}]}
{"nct_id":"NCT02172248","start_date":"2009-01-31","phase":"Phase 1","enrollment":16,"brief_title":"Relative Bioavailability BI 10773 and Metformin in Healthy Male Volunteers","official_title":"Relative Bioavailability of Both BI 10773 and Metformin After Coadministration Compared to Multiple Oral Doses of BI 10773 (50 mg q.d.) Alone and Metformin (1000 mg b.i.d.) Alone to Healthy Male Volunteers (an Open-label, Randomised, Crossover, Clinical Phase I Study)","primary_completion_date":"2009-03-31","study_type":"Interventional","rec_status":"Completed","last_update":"2014-06-24","description":"The objective was to investigate a possible drug-drug interaction between BI 10773 and metformin when co-administered as multiple oral doses. Therefore, the relative bioavailabilities of BI 10773 and metformin were determined when both drugs were given in combination compared with BI 10773 or metformin given alone.","other_id":"1245.6","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy male volunteers according to the following criteria: Based upon a complete\r\n             medical history, including the physical examination, vital signs (BP (Blood Pressure),\r\n             PR (Pulse Rate)), 12-lead ECG (Electrocardiogram), clinical laboratory tests\r\n\r\n          -  Age 18 to 50 years (incl.)\r\n\r\n          -  BMI (Body Mass Index) 18.5 to 29.9 kg/m2 (incl.)\r\n\r\n          -  Signed and dated written informed consent prior to admission to the study in\r\n             accordance with GCP (Good Clinical Practice) and the local legislation\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any finding of the medical examination (including BP, PR and ECG) deviating from\r\n             normal and of clinical relevance\r\n\r\n          -  Any evidence of a clinically relevant concomitant disease\r\n\r\n          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,\r\n             immunological or hormonal disorders\r\n\r\n          -  Surgery of the gastrointestinal tract (except appendectomy)\r\n\r\n          -  Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or\r\n             neurological disorders\r\n\r\n          -  History of relevant orthostatic hypotension, fainting spells or blackouts\r\n\r\n          -  Chronic or relevant acute infections\r\n\r\n          -  History of relevant allergy/hypersensitivity (including allergy to drug or its\r\n             excipients)\r\n\r\n          -  Intake of drugs with a long half-life (> 24 hours) within at least one month or less\r\n             than 10 half-lives of the respective drug prior to administration or during the trial\r\n\r\n          -  Participation in another trial with an investigational drug within two months prior to\r\n             administration or during the trial\r\n\r\n          -  Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)\r\n\r\n          -  Inability to refrain from smoking on trial days\r\n\r\n          -  Alcohol abuse (more than 30 g/day)\r\n\r\n          -  Drug abuse\r\n\r\n          -  Blood donation (more than 100 mL within four weeks prior to administration or during\r\n             the trial)\r\n\r\n          -  Excessive physical activities (within one week prior to administration or during the\r\n             trial)\r\n\r\n          -  Any laboratory value outside the reference range that is of clinical relevance\r\n\r\n          -  Inability to comply with dietary regimen of trial site\r\n      ","sponsor":"Boehringer Ingelheim","sponsor_type":"Industry","conditions":"Healthy","interventions":[{"intervention_type":"Drug","name":"Drug: BI 10773"},{"intervention_type":"Drug","name":"Drug: Metformin"}],"outcomes":[{"outcome_type":"primary","measure":"AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)","time_frame":"up to 7 days"},{"outcome_type":"primary","measure":"Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)","time_frame":"up to 7 days"},{"outcome_type":"secondary","measure":"C24,N (concentration of analyte in plasma at 24 hours post-drug administration after administration of the Nth dose) of BI 10773","time_frame":"up to 7 days"},{"outcome_type":"secondary","measure":"C12,N (concentration of analyte in plasma at 12 hours post-drug administration after administration of the Nth dose) of metformin","time_frame":"up to 7 days"},{"outcome_type":"secondary","measure":"λz,ss (terminal half-life of the analyte in plasma)","time_frame":"up to 7 days"},{"outcome_type":"secondary","measure":"t½,ss (terminal half-life of the analyte in plasma at steady state)","time_frame":"up to 7 days"},{"outcome_type":"secondary","measure":"tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state over a uniform dosing interval τ)","time_frame":"up to 7 days"},{"outcome_type":"secondary","measure":"MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration)","time_frame":"up to 7 days"},{"outcome_type":"secondary","measure":"CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state)","time_frame":"up to 7 days"},{"outcome_type":"secondary","measure":"Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration)","time_frame":"up to 7 days"},{"outcome_type":"secondary","measure":"Aet1-t2,ss (amount of analyte eliminated in urine at steady state over a uniform dosing interval τ)","time_frame":"1 hour pre-dose, 0-2, 2-4, 4-8, 8-12, 12-24 hours after last dosing"},{"outcome_type":"secondary","measure":"fet1-t2,ss (fraction of analyte excreted unchanged in urine at steady state over a uniform dosing interval τ)","time_frame":"1 hour pre-dose, 0-2, 2-4, 4-8, 8-12, 12-24 hours after last dosing"},{"outcome_type":"secondary","measure":"CLR,ss (renal clearance of the analyte at steady state) of BI 10773 and metformin","time_frame":"1 hour pre-dose, 0-2, 2-4, 4-8, 8-12, 12-24 hours after last dosing"},{"outcome_type":"secondary","measure":"Urinary glucose excretion (UGE)","time_frame":"1 hour pre-dose, 0-2, 2-4, 4-8, 8-12, 12-24 hours after last dosing"},{"outcome_type":"secondary","measure":"Number of patients with abnormal findings in physical examination","time_frame":"Baseline and within 3-14 days after last study drug administration"},{"outcome_type":"secondary","measure":"Number of patients with clinically significant changes in vital signs (Blood Pressure, Pulse Rate)","time_frame":"Baseline, day 1 and within 3-14 days after last study drug administration"},{"outcome_type":"secondary","measure":"Number of patients with abnormal findings in 12-lead ECG (electrocardiogram)","time_frame":"Baseline and within 3-14 days after last study drug administration"},{"outcome_type":"secondary","measure":"Number of patients with abnormal changes in clinical laboratory tests","time_frame":"Baseline, day 1, 4, 5 and within 3-14 days after last study drug administration"},{"outcome_type":"secondary","measure":"Number of patients with adverse events","time_frame":"up to 40 days"},{"outcome_type":"secondary","measure":"Assessment of tolerability by investigator on a 4-point scale","time_frame":"Within 3-14 days after last study drug administration"}]}
{"nct_id":"NCT02516579","start_date":"2009-01-31","enrollment":1906,"brief_title":"European Sickle Cell Disease Cohort - Hydroxyurea","official_title":"ESCORT-HU : European Sickle Cell Disease Cohort - Hydroxyurea","primary_completion_date":"2019-03-20","study_type":"Observational","rec_status":"Completed","completion_date":"2019-03-20","last_update":"2020-03-19","description":"In the context of the Risk Management Plan (RMP), as requested from Addmedica by the EMEA, to collect information about long-term safety of Siklos (hydroxycarbamide) when used in patients with Sickle Cell Disease.","other_id":"ESCORT-HU","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":2,"population":"Patient with sickle-cell disease","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female ambulatory patients, aged 2 years and more (children, adolescents or\r\n             adults)\r\n\r\n          -  With symptomatic sickle cell syndrome\r\n\r\n          -  Treated with Siklos\r\n\r\n          -  Having been informed of the study by the initiating physician and consenting to\r\n             participate to the cohort.\r\n      ","sponsor":"ADDMEDICA SASA","sponsor_type":"Industry","conditions":"Sickle Cell Disease","interventions":[{"intervention_type":"Drug","name":"Drug: Siklos"}],"outcomes":[{"outcome_type":"primary","measure":"% of Patient-years With Malignancies","time_frame":"During the follow-up of participant, up to 10 years"},{"outcome_type":"primary","measure":"% of Patient-years With Skin Ulcerations","time_frame":"During the follow-up of participant, up to 10 years","description":"Patients with at least one skin ulceration"},{"outcome_type":"primary","measure":"% of Patient-years With Myelosuppressions","time_frame":"During the follow-up of participant, up to 10 years","description":"Patients with at least one myelosuppression"}]}
{"nct_id":"NCT00807573","start_date":"2008-12-31","phase":"Phase 2","enrollment":44,"brief_title":"Paclitaxel, Bevacizumab and Pemetrexed in Patients With Untreated, Advanced Non-Small Cell Lung Cancer Using Web-Based Data Collection, Patient Self-Reporting of Adverse Effects and Automated Response Assessment","official_title":"A Phase II Trial of Paclitaxel, Bevacizumab and Pemetrexed in Patients With Untreated, Advanced Non-Small Cell Lung Cancer Using Web-Based Data Collection, Patient Self-Reporting of Adverse Effects and Automated Response Assessment","primary_completion_date":"2014-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-04-30","last_update":"2015-12-30","description":"The purpose of this study is to determine the percentage of patients with non-small cell lung cancer that will experience a shrinkage of their tumors following treatment with three medications given together: paclitaxel, pemetrexed (Alimta), and bevacizumab (Avastin). Each of these medications has been approved by the FDA for patients that have not received any treatment for their lung cancer. This study is designed to study the effects of all three drugs given at the same time. Each of these medications has been studied in lung cancer and is commercially available. Paclitaxel and pemetrexed are traditional chemotherapy drugs. Bevacizumab is a monoclonal antibody, which means that it attaches to a specific target. Bevacizumab attaches to a protein in the blood stream called Vascular Endothelial GrowthFactor (VEGF). VEGF helps tumors grow new blood vessels to feed themselves, and bevacizumab is thought to help block this new growth of blood vessels and starve the tumors of the nutrients they need.","other_id":"08-109","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Pathologically confirmed Non-Small Cell Lung Cancer at MSKCC\r\n\r\n          -  Clinical stage IIIB or IV.\r\n\r\n          -  Measurable disease as per RECIST\r\n\r\n          -  Greater than 6 months since receiving neo-adjuvant or adjuvant chemotherapy for\r\n             Non-Small Cell Lung Cancer.\r\n\r\n          -  Age  18 years.\r\n\r\n          -  Karnofsky performance status of  to 70.\r\n\r\n          -  Marrow and organ function as follows:\r\n\r\n          -  WBC  to 4000/mm3\r\n\r\n          -  Platelets  to 160,000\r\n\r\n          -  Bilirubin  to 1.2mg/dL\r\n\r\n          -  Creatinine clearance  to 40mL/min\r\n\r\n          -  AST and/or /ALT  37 Units/L (if one of these elevated, must be  2.5 ULN)\r\n\r\n          -  Systolic blood pressure  to 150mmHg or diastolic blood pressure  to 100 mmHg).\r\n\r\n          -  The subject is able to read and comprehend English text from a computer screen.\r\n\r\n          -  Women of childbearing potential and sexually active men enrolled in the study must\r\n             agree to practice effective contraception.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Squamous cell carcinoma.\r\n\r\n          -  Prior treatment with paclitaxel, pemetrexed or bevacizumab for NSCLC.\r\n\r\n          -  Prior systemic anticancer therapy for advanced NSCLC.\r\n\r\n          -  Symptomatic brain metastases with evidence of hemorrhage.\r\n\r\n          -  Radiation therapy to greater than 25% of the bone marrow within 30 days of starting\r\n             treatment.\r\n\r\n          -  Peripheral neuropathy greater than grade 1.\r\n\r\n          -  Malignancies within the past 5 years other than non-melanoma skin cancer.\r\n\r\n          -  Patients with other serious medical illnesses including, ongoing or active infection,\r\n             symptomatic congestive heart failure, unstable angina pectoris, or psychiatric\r\n             illness/social situations that would limit compliance with study requirements.\r\n\r\n          -  History of hemoptysis.\r\n\r\n          -  History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess.\r\n\r\n          -  History of myocardial infarction or stroke within 6 months prior to enrollment.\r\n\r\n          -  Pregnancy or lactation.\r\n      ","sponsor":"Memorial Sloan Kettering Cancer Center","sponsor_type":"Other","conditions":"Lung Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Paclitaxel","description":"Day 1: Paclitaxel (90 mg/m^2 over 60 minutes) Day 15: Paclitaxel (90 mg/m^2 over 60 minutes)"},{"intervention_type":"Drug","name":"Drug: Pemetrexed","description":"Day 1: Pemetrexed (500 mg/m^2 over 10 minutes) Day 15 Pemetrexed (500 mg/m2 over 10 minutes)"},{"intervention_type":"Drug","name":"Drug: Bevacizumab","description":"Day 1:Bevacizumab (10 mg/kg over 20 minutes) Day 15: Bevacizumab (10 mg/kg over 20 minutes)"}],"outcomes":[{"outcome_type":"primary","measure":"Objective Response Rate (CR + PR by RECIST) Paclitaxel, Pemetrexed, and Bevacizumab in Patients With Advanced Non-Small Lung Cancer Who Have Received no Prior Treatment for Metastatic Disease.","time_frame":"2 years","description":"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."}]}
{"nct_id":"NCT00792714","start_date":"2008-12-31","phase":"Phase 1","enrollment":18,"brief_title":"Pharmacokinetics of Inhaled Mannitol in Cystic Fibrosis Patients","official_title":"Determination of the Pharmacokinetics of Inhaled Mannitol After Single and Multiple Dosing in Cystic Fibrosis Patients","primary_completion_date":"2009-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-09-30","last_update":"2010-02-02","description":"The general objective of the study is to estimate the systemic pharmacokinetics of mannitol after single and multiple dosing of IDPM 400 mg to adult and paediatric cystic fibrosis patients.","other_id":"DPM-PK-102","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":6,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Have given written informed consent to participate in this study in accordance with\r\n             local regulations\r\n\r\n          -  Have a confirmed diagnosis of cystic fibrosis (sweat test and/or genotype)\r\n\r\n          -  Be aged >6 years (6-11 for paediatrics, 12-17 for adolescents and 18 years for adults)\r\n\r\n          -  Have FEV1 > 30 % and < 90% predicted\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Be investigators, site personnel directly affiliated with this study, or their\r\n             immediate families. Immediate family is defined as a spouse, parent, child or sibling,\r\n             whether biologically or legally adopted.\r\n\r\n          -  Be considered \"terminally ill\" or listed for lung transplantation\r\n\r\n          -  Have had a lung transplant\r\n\r\n          -  Be using nebulised hypertonic saline\r\n\r\n          -  Have had a significant episode of haemoptysis (> 60 mL) in the three months prior to\r\n             enrolment\r\n\r\n          -  Have had a myocardial infarction in the three months prior to enrolment\r\n\r\n          -  Have had a cerebral vascular accident in the three months prior to enrolment\r\n\r\n          -  Have had major ocular surgery in the three months prior to enrolment\r\n\r\n          -  Have had major abdominal, chest or brain surgery in the three months prior to\r\n             enrolment\r\n\r\n          -  Have a known cerebral, aortic or abdominal aneurysm\r\n\r\n          -  Be breast feeding or pregnant, or plan to become pregnant while in the study\r\n\r\n          -  Be using an unreliable form of contraception (female patients at risk of pregnancy\r\n             only)\r\n\r\n          -  Be participating in another investigative drug study, parallel to, or within 4 weeks\r\n             of study entry (except inhaled mannitol)\r\n\r\n          -  Not able to maintain a mannitol free diet from Day -2 until Day 8 of the treatment\r\n             phase.\r\n\r\n          -  Have a known allergy to mannitol\r\n\r\n          -  Be using beta blockers\r\n\r\n          -  Have uncontrolled hypertension - systolic blood pressure > 190 and / or diastolic\r\n             blood pressure > 100\r\n\r\n          -  Have a condition or be in a situation which in the Investigator's opinion may put the\r\n             subject at significant risk, may confound results or may interfere significantly with\r\n             the patient's participation in the study\r\n\r\n          -  Be MTT positive.\r\n      ","sponsor":"Pharmaxis","sponsor_type":"Industry","conditions":"Cystic Fibrosis","interventions":[{"intervention_type":"Drug","name":"Drug: Mannitol","description":"400mg twice daily for 7 days"}],"outcomes":[{"outcome_type":"primary","measure":"The general objective of the study is to estimate the systemic pharmacokinetics of mannitol after single and multiple dosing of IDPM 400 mg to adult and paediatric cystic fibrosis patients.","time_frame":"8 days"}]}
{"nct_id":"NCT00805025","start_date":"2008-12-31","phase":"Phase 2","enrollment":89,"brief_title":"Evaluation of the Quality of Life Questionnaire-Bronchiectasis (QOL-B) in Patients With Bronchiectasis","official_title":"An Open-Label, Multicenter Trial to Validate the Quality of Life Questionnaire-Bronchiectasis and to Evaluate Perception of Symptom Improvement Following One Course of Aztreonam for Inhalation Solution (AZLI) in Subjects With Bronchiectasis and Gram-negative Bacteria in the Airways","primary_completion_date":"2009-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-10-31","last_update":"2014-03-20","description":"Over the 70-day study period, eligible patients visited the study clinic every 2 weeks (total of 6 visits) and received a 28-day course of aztreonam for inhalation solution (AZLI). The Quality of Life-Bronchiectasis (QOL-B) questionnaire was completed at several time points during the study, in additional to pulmonary function testing and other standard procedures.","other_id":"GS-US-219-0102","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Written informed consent prior to any study-related procedures\r\n\r\n          -  Ability to read and understand the English language\r\n\r\n          -  Bronchiectasis confirmed by CT scan of the chest\r\n\r\n          -  Previous treatment with antibiotics for bronchiectasis\r\n\r\n          -  Documented history of positive sputum culture for a gram-negative organism within 5\r\n             years\r\n\r\n          -  Positive sputum culture for a gram-negative organism at first visit (Day -14)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Hospitalization or hemoptysis > 30 mL within 14 days of first visit (Day -14)\r\n\r\n          -  Antibiotic use for respiratory symptoms within 14 days of first visit (Day -14),\r\n             excluding chronic, stable azithromycin use\r\n\r\n          -  Change in corticosteroid or bronchodilator regimen within 14 days of first visit (Day\r\n             -14)\r\n\r\n          -  Forced expiratory volume in 1 second (FEV1) < 25% predicted approximately 15 minutes\r\n             following use of a bronchodilator at first visit (Day -14)\r\n\r\n          -  Cigarette smoking within 6 months of first visit (Day -14)\r\n      ","sponsor":"Gilead Sciences","sponsor_type":"Industry","conditions":"Bronchiectasis","interventions":[{"intervention_type":"Drug","name":"Drug: AZLI","description":"75 mg aztreonam for inhalation solution (AZLI), administered 3 times daily using the PARI Investigational eFlow Nebulizer System (with a minimum of 4 hours between doses) following administration of a short-acting bronchodilator"}],"outcomes":[{"outcome_type":"primary","measure":"Reliability of the Respiratory Domain of the Quality of Life Questionnaire-Bronchiectasis (QOL-B)","time_frame":"Day -14 to Day 0","description":"Test-retest reliability is a measure of the stability or reproducibility of a measure over a period of time during which status on the underlying construct has not changed, and is measured by the intraclass correlation of scores obtained at 2 time points within that period. Test-retest reliability of respiratory symptoms was calculated for response at Day -14 and Day 0. Reliability of the participants' QOL-B responses was assessed from an Intraclass Correlation Coefficient (ICC). A score of ≥ 0.70 would indicate strong reliability.\r\nThe QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life."},{"outcome_type":"primary","measure":"Convergent Validity of the Respiratory Domain of the QOL-B","time_frame":"Day -14","description":"Convergent validity was assessed at Day -14 by examining the correlations between relevant QOL-B domains and other indicators of health status: a bronchiectasis severity score based on high-resolution computerised tomography (HRCT) scan results, forced expiratory volume in 1 second (FEV1) percent predicted, 6-minute walk test (6MWT) results, and St. George's Respiratory Questionnaire (SGRQ) symptoms scores. Correlations with absolute values of 0.30 to 0.50 indicated moderate evidence of convergent validity."},{"outcome_type":"secondary","measure":"Responsiveness of the Respiratory Domain of the QOL-B as Assessed by the Anchor-based Minimal Clinically Important Difference (MCID) Following Categorization of Level of Change Using the Global Rating of Change Questionnaire (GRCQ)","time_frame":"Day 0 to Day 28","description":"The anchor-based method measured the participant's perception of change at Day 28 using the GRCQ, which assesses improving/worsening symptoms. Distribution of ratings was categorized as no change (-1 to 1), minimal change (≥ 1.1 to < 3.1 or ≤ -1.1 to > -3.1), moderate change (≥ 3.1 to < 5.1 or ≤ -3.1 to > -5.1) or large change (≥ 5.1, ≤ -5.1). The GRCQ evaluated change in respiratory symptoms on a visual analog scale from -7 (worsening) to +7 (improvement). The following algorithm was used to obtain the mean change:\r\nIf the corresponding GRCQ score was in the \"no change\" group, then change from baseline QOL-B = Observed QOL-B change from baseline score; if > 1, then change from baseline QOL-B score = Observed QOL-B change from baseline score; if < -1, the change from baseline QOL-B score = (-1) * Observed QOL-B change from baseline score.\r\nThen the mean change from baseline of QOL-B respiratory symptoms score of the minimal change category group is the anchor-based MCID."}]}
{"nct_id":"NCT01717144","start_date":"2008-12-31","phase":"N/A","enrollment":120,"brief_title":"Education in Therapy of Parkinson's Disease","official_title":"EVALUATION OF A THERAPEUTIC EDUCATION PROGRAMME IN PARKINSON'S DISEASE","primary_completion_date":"2008-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-04-30","last_update":"2017-05-12","description":"Parkinson's disease (PD) has considerable impact on motor, psychological and social activities and significantly affects the quality of life of patients and their families. To improve the medical care of PD patients, the investigator have developed an educational program specific to PD. The principal aim of this study is to evaluate the therapeutic education Program, comparing the quality of life of PD patients with or without the educational program after six month and one year follow-up. The secondary aims are to evaluate the evolution of motor and psychological states in these 2 groups of patients and to compare the medical costs. This is a monocentric, comparative, prospective randomised study. The investigators will evaluate 120 PD patients, 60 patients benefiting of the educational program and 60 patients with a traditional medical care. Quality of life of PD patients is evaluated using a specific scale (PDQ39) and a generalist scale (SF36) at 6 and 12 months. Motor and psychological states were assessed with UPDRS and HAD Scales. The educational program consisted of both individual and collective educational consultations. The investigators supposed that the therapeutic education program will improve the quality of life of PD patients. The supposition that this improvement will correlate with the motor and psychological states.","other_id":"08 150 07","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":30,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with clinical diagnosis of Parkinson's disease according to the criteria of\r\n             the UKPDSBB\r\n\r\n          -  Parkinson's disease patients with a score 4 on the Hoehn and Year scale\r\n\r\n          -  Patient without cognitive disorders\r\n\r\n          -  Patients treated with dopaminergic antiparkisonian drugs (L-DOPA, dopamine\r\n             agonists,ICOMT) or DBS stimulation (since at least 3 month)\r\n\r\n          -  Patients able to fulfil self-administered questionnaire\r\n\r\n          -  Patients affiliated to a social protection program\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  - Patients suffering from an other pathology causing chronic pain (rheumatic disease,\r\n             traumatic or orthopaedic pathologies)\r\n\r\n          -  Parkinson's disease patients with a score>5 on the Hoehn and Yahr scale\r\n\r\n          -  Patients suffering of parkinsonism induce by drugs\r\n\r\n          -  Patients with important tremors during a OFF conditions\r\n\r\n          -  Patients ever included in another study\r\n\r\n          -  Patients with severe psychiatric disease\r\n\r\n          -  Patients under tutelage, curatelle or law protection\r\n\r\n          -  Patients included in an other clinical study\r\n\r\n          -  Patients unable to fulfil scales of the study\r\n      ","sponsor":"University Hospital, Toulouse","sponsor_type":"Other","conditions":"Parkinson Disease","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: therapeutic education program","description":"The educational program consisted of both individual and collective educational consultations with a therapeutic education nurse"}],"outcomes":[{"outcome_type":"secondary","measure":"The psychological state with HAD (Hospital Anxiety and Depression) scale","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Quality of life with the SF36 scale","time_frame":"1 year"},{"outcome_type":"secondary","measure":"the motor state with UPDRS (Unified Pakinson's disease Rating Scale)","time_frame":"1 year"},{"outcome_type":"primary","measure":"Quality of life with the PDQ39 scale","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Evaluation of social adaptation with SAS-SR (Social adjustement Scale Sel-Report) scale","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Evaluation of medical costs","time_frame":"over the 12 months follow-up"}]}
{"nct_id":"NCT00813033","start_date":"2008-12-31","phase":"N/A","enrollment":80,"brief_title":"Use of a Patient Decision Aid for Gastrologic Endoscopy in a Pediatric Setting","official_title":"Creation and Pilot Evaluation of a Patient Decision Aid as an Adjunct to the Consenting Process for Gastrointestinal Endoscopy in a Pediatric Setting","primary_completion_date":"2011-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-03-31","last_update":"2011-06-27","description":"Parents need understandable information in order to make appropriate choices for their child's health care. This is especially true when making decisions about invasive medical procedures. Parents need to understand what will happen, the risks involved, how these risks will be managed and what other options they have before they can decide what is best for their child. The present proposal involves the creation of a novel patient decision aid about the gastro endoscopy procedure, called a \"scope.\" The purpose of the aid is to provide parents with information so they are able to discuss the options with their child's health care providers.","other_id":"CMH080104.2","allocation":"N/A","intervention_model":"Single Group Assignment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  parents or LARs who are considering a gastro-endoscopy for their child\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  child has previously undergone an endoscopy\r\n\r\n          -  parent of child has undergone an endoscopy\r\n\r\n          -  non-English speaking\r\n      ","sponsor":"Children's Mercy Hospital Kansas City","sponsor_type":"Other","conditions":"Endoscopy","interventions":[{"intervention_type":"Other","name":"Other: patient decision aid for endoscopy","description":"patient decision aid will be administered at the point of decision making"}],"outcomes":[{"outcome_type":"primary","measure":"Validated survey tools will be used to assess change in the consenting parent's knowledge, expectations of outcomes, clarity of values, decision and decision conflict.","time_frame":"immeadiately after completing patient decision aid"}]}
{"nct_id":"NCT00796367","start_date":"2008-12-31","phase":"Phase 3","enrollment":676,"brief_title":"A Safety and Efficacy Study of VI-0521 to Evaluate the Long Term Treatment of Obesity in Adults With Obesity-Related Co-Morbid Conditions. An Extension Study of Protocol OB-303 (NCT00553787)","official_title":"A Phase 3, Double-Blind, Placebo-Controlled, Multicenter Extension Study (From Study OB-303 [NCT00553787]) to Determine the Safety and Efficacy Of VI-0521 for the Long-Term Treatment Of Obesity in Adults With Obesity-Related Co-Morbid Conditions.","primary_completion_date":"2010-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-07-31","last_update":"2012-09-10","description":"The purpose of this study is to evaluate the long-term safety and efficacy of VI-0521 compared to placebo for the treatment of overweight and obesity in adults who have completed study OB-303 (NCT00553787) at selected study sites. This is an extension study of protocol OB-303 (NCT00553787).","other_id":"OB-305","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        To be eligible for enrollment into this study, subjects must meet all of the following\r\n        criteria:\r\n\r\n          -  Completion of study OB-303 (NCT00553787) on treatment and compliance with all protocol\r\n             requirements\r\n\r\n          -  Written informed consent\r\n\r\n          -  Female subjects of childbearing potential must be using adequate contraception,\r\n             defined as double-barrier methods, stable hormonal contraception plus single barrier\r\n             method, or tubal ligation. Female subjects are considered to be of childbearing\r\n             potential unless they have undergone a hysterectomy or bilateral oophorectomy, are 55\r\n             years of age and experienced spontaneous cessation of menses for at least 1 year, or\r\n             have a documented follicle-stimulating hormone level 40 IU/L\r\n\r\n          -  Willingness and ability to comply with scheduled visits, treatment plan, laboratory\r\n             tests, and other study procedures.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Subjects will not be included in the study if they meet any of the following:\r\n\r\n          -  Body mass index 22 kg/m2 at the completion of study OB-303\r\n\r\n          -  Off study medication at completion of study OB-303 (NCT00553787) for longer than 4\r\n             weeks continuously due to an event-driven holiday, or off study medication with no\r\n             plans to restart\r\n\r\n          -  Development of any condition during study OB-303 (NCT00553787) that, in the opinion of\r\n             the investigator, would contraindicate the administration of study medication, affect\r\n             compliance, interfere with study evaluations, or confound the interpretation of study\r\n             results\r\n\r\n          -  Participation in a formal weight loss program (including: Weight Watchers and related\r\n             dietary/lifestyle intervention programs; prepared food programs; prescribed or over\r\n             the counter weight loss medications; dietary supplement or herbal preparations, teas,\r\n             or tinctures intended for weight loss; or any supervised fast or very low calorie\r\n             diet).\r\n      ","sponsor":"VIVUS, Inc.","sponsor_type":"Industry","conditions":"Obesity","interventions":[{"intervention_type":"Drug","name":"Drug: VI-0521","description":"7.5 mg phentermine and 46 mg topiramate"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"placebo"},{"intervention_type":"Drug","name":"Drug: VI-0521","description":"15 mg phentermine and 92 mg topiramate"}],"outcomes":[{"outcome_type":"primary","measure":"Percent Weight Change at End of Treatment, Week 108.","time_frame":"From baseline to end of treatment"},{"outcome_type":"primary","measure":"Percentage of Subjects With at Least 5% Weight Loss at End of Treatment, Week 108.","time_frame":"Baseline to End of Treatment"}]}
{"nct_id":"NCT00805077","start_date":"2008-12-31","phase":"N/A","enrollment":347,"brief_title":"Pulmonary Surgery and Protective Mechanical Ventilation","official_title":"Pulmonary Surgery and Protective Mechanical Ventilation","primary_completion_date":"2011-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-07-31","last_update":"2013-07-29","description":"The purpose of this trial is to evaluate the efficacy and the safety of lung protective ventilation during anesthesia in patients undergoing pneumonectomy or lobectomy for lung cancer.","other_id":"P070119","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":90,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Primary lung cancer.\r\n\r\n          -  Elective Pneumonectomy or lobectomy or bilobectomy\r\n\r\n          -  Written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients undergoing surgical procedure other than pneumonectomy or lobectomy or\r\n             bilobectomy\r\n\r\n          -  Mesothelioma\r\n\r\n          -  Liver cirrhosis\r\n\r\n          -  Chronic renal failure\r\n\r\n          -  Need for mechanical ventilation or non invasive ventilation (CPAP for obstructive\r\n             sleep apnea syndrome for example) before surgery\r\n\r\n          -  Emergency surgery\r\n      ","sponsor":"Assistance Publique - Hpitaux de Paris","sponsor_type":"Other","conditions":"Lung Neoplasms","interventions":[{"intervention_type":"Procedure","name":"Procedure: mechanical ventilation","description":"mechanical ventilation with low tidal volume (5 ml/kg of ideal body weight) plus PEEP"},{"intervention_type":"Other","name":"Other: tidal volume","description":"tidal volume of 10 ml/kg of ideal body weight without PEEP"}],"outcomes":[{"outcome_type":"primary","measure":"Major postoperative complications during the first 30 days after surgery","time_frame":"the first 30 days after surgery"},{"outcome_type":"secondary","measure":"Minor postoperative complications during the first 30 days after surgery, length of stay in ICU and hospital, cancer recurrence, death","time_frame":"during the first 30 days after surgery"}]}
{"nct_id":"NCT00812773","start_date":"2008-12-31","phase":"Phase 2","enrollment":17,"brief_title":"Study to Evaluate GSK2190915 in Subjects With Mild Asthma","official_title":"A Randomised, Double-blind, Placebo-controlled, 3-period Cross-over Study to Evaluate the Effect of Two Doses of GSK2190915 on the Allergen-induced Early Asthmatic Response in Subjects With Mild Asthma","primary_completion_date":"2009-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-07-31","last_update":"2016-10-12","description":"This study will evaluate the safety and effect of repeat oral doses of GSK2190915 on lung function in mild asthmatics using a number of clinical and biological markers of efficacy.","other_id":"112356","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Body mass index within the range 18.5-35.0 kilograms/metre2 (kg/m2)\r\n\r\n          -  Female subjects must be of non childbearing potential including pre-menopausal females\r\n             with documented (medical report verification) hysterectomy or double oophrectomy or\r\n             postmenopausal defined as 12 months of spontaneous amenorrhea or 6 months of\r\n             spontaneous amenorrhea with serum FSH levels > 40 mIU/mL and estradiol < 40 pg/ml\r\n             (<140 pmol/L) or 6 weeks postsurgical bilateral oophorectomy with or without\r\n             hysterectomy.\r\n\r\n          -  Male subjects must agree to use one of the contraception methods listed in the\r\n             protocol. This criterion must be followed from the time of the first dose of study\r\n             medication until 5 terminal half-lives post-last dose.\r\n\r\n          -  Documented history of bronchial asthma, first diagnosed at least 6 months prior to the\r\n             screening visit and currently being treated only with intermittent short-acting beta\r\n             -agonist therapy by inhalation.\r\n\r\n          -  Pre-bronchodilator FEV1 >70% of predicted at screening.\r\n\r\n          -  Subjects who are current non-smokers who have not used any tobacco products in the\r\n             6-month period preceding the screening visit and have a pack history of <= 10 pack\r\n             years.\r\n\r\n        [number of pack years = (number of cigarettes per day/20) x number of years smoked]\r\n\r\n          -  Demonstration of a positive wheal and flare reaction (>= 3 mm relative to negative\r\n             control) to at least one allergen from a battery of allergens (including house dust\r\n             mite, grass pollen and cat hair) on skin prick testing at screening, or within 12\r\n             months of study start.\r\n\r\n          -  Methacholine challenge PC20 < 8 mg/mL at screening or previous (in last 6 months) AMP,\r\n             histamine or methacholine challenge that confirms the diagnosis of asthma\r\n\r\n          -  Screening allergen challenge demonstrates that the subject experiences an early\r\n             asthmatic response. The early asthmatic response must include a fall in FEV1 of >= 20%\r\n             from the post saline value, on at least one occasion, between 5 and 30 minutes after\r\n             the final concentration of allergen. Data obtained from screening for LPA111834 may be\r\n             used for this criteria.\r\n\r\n          -  Signed and dated written informed consent is obtained from the subject\r\n\r\n          -  The subject is able to understand and comply with the protocol requirements,\r\n             instructions and protocol-stated restrictions.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Past or present disease, which as judged by the investigator or medical monitor, may\r\n             affect the outcome of this study. These diseases include, but are not limited to,\r\n             cardiovascular disease, malignancy, gastrointestinal disease, hepatic disease, renal\r\n             disease, haematological disease, neurological disease, endocrine disease or pulmonary\r\n             disease\r\n\r\n          -  Clinically significant abnormalities in safety laboratory analysis at screening.\r\n\r\n          -  Subject has known history of hypertension or is hypertensive at screening.\r\n             Hypertension at screening is defined as persistent systolic BP >150 mmHg or diastolic\r\n             BP > 90mmHg.\r\n\r\n          -  Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the\r\n             first dose of study medication\r\n\r\n          -  History of life-threatening asthma, defined as an asthma episode that required\r\n             intubation and/or was associated with hypercapnoea, respiratory arrest and/or hypoxic\r\n             seizures\r\n\r\n          -  Symptomatic with hay fever at screening or predicted to have symptomatic hay fever\r\n             during the time of study\r\n\r\n          -  Administration of oral or injectable steroids within 5 weeks of screening or\r\n             intranasal and/or inhaled steroids within 4 weeks of the screening visit.\r\n\r\n          -  Unable to abstain from other medications including non-steroidal anti-inflammatory\r\n             drugs (NSAIDs), anti-depressant drugs, anti-histamines and anti-asthma, anti-rhinitis\r\n             or hay fever medication, other than short acting inhaled beta-agonists and paracetamol\r\n             (up to 4 g per day) for the treatment of minor ailments eg headache from 14 days\r\n             before screening until the follow-up visit.\r\n\r\n          -  Unable to abstain from short acting beta agonists within 8 hours prior to an allergen\r\n             challenge, dosing with study drug or any lung function assessment.\r\n\r\n          -  If, after 2 concurrent administrations of saline during the allergen challenge at\r\n             screening the subjects still have a fall in FEV1 of greater than 10%.\r\n\r\n          -  The subject has participated in a study with a new molecular entity during the\r\n             previous 3 months or has participated in 4 or more clinical studies in the previous 12\r\n             months prior to the first dosing day.\r\n\r\n          -  History of being unable to tolerate or complete allergen challenge tests.\r\n\r\n          -  Subject is undergoing allergen desensitisation therapy.\r\n\r\n          -  There is a risk of non-compliance with study procedures.\r\n\r\n          -  History of blood donation (500 mL) within 3 months of starting the clinical study.\r\n\r\n          -  The subject regularly drinks more than 28 units of alcohol in a week if male, or 21\r\n             units per week if female. One unit of alcohol is defined as a medium (125 ml) glass of\r\n             wine, half a pint (250 ml) of beer or one measure (25 ml) of spirits.\r\n\r\n          -  The subject has a screening QTc value of >450msec, PR interval outside the range 120\r\n             to 220msec or an ECG that is not suitable for QT measurements (e.g. poorly defined\r\n             termination of the T-wave).\r\n\r\n          -  The subject has tested positive for hepatitis C antibody or hepatitis B surface\r\n             antigen.\r\n\r\n          -  The subject has tested positive for HIV antibodies.\r\n\r\n          -  The subject has a positive pre-study urine cotinine/ breath carbon monoxide test or\r\n             urine drug or urine or breath alcohol screen. A minimum list of drugs that will be\r\n             screened for include Amphetamines, Barbituates, Cocaine, Opiates, Cannabinoids and\r\n             Benzodiazepines.\r\n      ","sponsor":"GlaxoSmithKline","sponsor_type":"Industry","conditions":"Asthma","interventions":[{"intervention_type":"Drug","name":"Drug: GSK2190915","description":"Investigational Product"}],"outcomes":[{"outcome_type":"primary","measure":"Early Asthmatic Response","time_frame":"0-2 hours after allergen challenge on Day 3 of each treatment period."},{"outcome_type":"secondary","measure":"Lung function as measured by FEV1","time_frame":"Days 1 and 3"},{"outcome_type":"secondary","measure":"Assess safety and tolerability","time_frame":"Throughout study"}]}
{"nct_id":"NCT00723957","start_date":"2008-12-31","phase":"Phase 2","enrollment":260,"brief_title":"A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Advanced Nonsmall-Cell Lung Cancer","official_title":"A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Patients With Advanced Non-small Cell Lung Cancer","primary_completion_date":"2010-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-08-31","last_update":"2020-10-28","description":"The purpose of this study is to determine whether progression-free survival with ixabepilone is superior to that achieved with paclitaxel plus carboplatin in participants with advanced nonsmall-cell lung cancer and beta III (III)-tubulin-positive tumors.","other_id":"CA163-163","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically confirmed non-small cell lung cancer (NSCLC)(squamous cell,\r\n             adenocarcinoma, large cell, or bronchoalveolar carcinoma)\r\n\r\n          -  Stage IIIB NSCLC with pleural effusion, Stage IV NSCLC, or recurrent disease following\r\n             surgery with or without radiation therapy\r\n\r\n          -  Available paraffin-embedded tissue to measure the expression levels of III tubulin\r\n\r\n          -  Disease measurable by Response Evaluation Criteria in Solid Tumors, with at least 1\r\n             target lesion situated outside any previous radiotherapy field\r\n\r\n          -  Karnofsky performance status of 70-100\r\n\r\n          -  Life expectancy of at least 3 months\r\n\r\n          -  Men and women, ages 18 years and older\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Uncontrolled brain metastases\r\n\r\n          -  Peripheral neuropathy greater than Grade 1\r\n\r\n          -  Fewer than 4 weeks from prior radiation therapy or locoregional surgeries to\r\n             randomization date (less than 1 week from focal/palliative radiotherapy or minor\r\n             surgery)\r\n\r\n          -  Any concurrent malignancy other than nonmelanoma skin cancer or carcinoma in situ of\r\n             the cervix\r\n\r\n          -  Known HIV-positive status\r\n\r\n          -  Absolute neutrophil count lower than 1500 cells mm^3\r\n\r\n          -  Total bilirubin level higher than upper limit of normal (ULN) as defined by the\r\n             institution (with the exception of elevation due to Gilbert's syndrome)\r\n\r\n          -  Aspartate transaminase or alanine transaminase level higher than 2.5*ULN\r\n\r\n          -  Serum creatine level of 1.5 mg/dL or higher\r\n\r\n          -  Renal function with a creatinine clearance of less than 50 mL/min (as calculated with\r\n             the Cockcroft and Gault equation)\r\n\r\n          -  Any prior antineoplastic systemic regimens.\r\n      ","sponsor":"R-Pharm","sponsor_type":"Industry","conditions":"Advanced/Metastatic Non-Small Cell Lung Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Ixabepilone, 32 mg/m^2","description":"Intravenous (IV) solutions, ixabepilone, 32 mg/m^2"},{"intervention_type":"Drug","name":"Drug: Paclitaxel, 200 mg/m^2","description":"IV solutions, paclitaxel, 200 mg/m^2"},{"intervention_type":"Drug","name":"Drug: Carboplatin (area under the concentration curve [AUC] 6)","description":"Carboplatin (AUC 6) day 1, every 21 days, 6 cycles"}],"outcomes":[{"outcome_type":"primary","measure":"Progression-free Survival in the Subgroup of Participants With βIII-tubulin Positive Tumors","time_frame":"Randomization to disease progression or death (maximum reached: 14.39 months )","description":"Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on-study tumor assessment, progression-free survival was censored at the date of randomization. A tumor was considered to be beta III (βIII)-tubulin positive if 50% or more of the tumor cells had a βIII-tubulin immunohistochemistry staining intensity equal to or greater than that of the positive control."},{"outcome_type":"secondary","measure":"Progression-free Survival in the Subgroup of Participants With βIII-tubulin Negative Tumors","time_frame":"Randomization to disease progression or death (maximum reached: 12.29 months)","description":"Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on study tumor assessment, progression-free survival was censored at the date of randomization."},{"outcome_type":"secondary","measure":"Progression-free Survival in the Overall Population","time_frame":"Randomization to disease progression or death, assessed to 12.29 months","description":"Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on study tumor assessment, progression-free survival was censored at the date of randomization."},{"outcome_type":"secondary","measure":"Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR)","time_frame":"At randomization and then every 6 weeks to date of CR, PR, or progression for 6 21-day cycles","description":"Response evaluated per Response Evaluaton in Solid Tumor (V1.0) guidelines and assessed using magnetic resonance imaging. Percentage of best response=the total number of participants with the best overall response of CR or PR divided by the total number of randomized participants in that treatment arm. CR=disappearance of all target lesions; PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD."},{"outcome_type":"secondary","measure":"Time to Response","time_frame":"Randomization to date of first response (PR or CR)","description":"Time to Response is defined as the time from randomization date until the date of first response (Partial Response [PR] or Complete Response [CR])"},{"outcome_type":"secondary","measure":"Number of Participants With Death as Outcome, Drug-related Adverse Events (AEs), Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation, and Drug-related Peripheral Neuropathy","time_frame":"Days 1 through 21, continuously","description":"An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related is defined as possibly, probably, or certainly related to and of unknown relationship to study treatment."},{"outcome_type":"secondary","measure":"Number of Participants With Hematology Laboratory Results of Grade 3 or 4","time_frame":"At screening and weekly during 21-day cycle","description":"LLN=lower level of normal. Leukocytes (leukopenia) Grade 1: <LLN to 3.0*10^9/L, Grade 2:<3.0 to 2.0*10^9/L, Grade 3: <2.0 to 1.0*10^9/L, Grade 4: <1.0*10^9/L; Neutrophils (neutropenia) Grade 1: <LLN to 1.5*10^9/L, Grade 2: <1.5 to 1.0*10^9/L, Grade 3: <1.0 to 0.5*10^9/L, Grade 4: <0.5*10^9/L; Platelet count(thrombocytopenia) Grade 1: LLN to 75.0*10^9/L, Grade 2: <75.0 to 50.0*10^9/L, Grade 3: <50.0 to 25.0*10^9/L, Grade 4:<25.0 to 10^9/L; Hemoglobin (anemia) Grade 1: <LLN to 10.0 g/dL, Grade 2: <10.0 to 8.0 g/dL, Grade 3: <8.0 to 6.5 g/dL, Grade 4: <6.5 g/dL."},{"outcome_type":"secondary","measure":"Number of Participants With Grade 3 or 4 Abnormalities in Liver Function and Urine Laboratory Test Results","time_frame":"At screening and within 72 hours of start of 21-day cycle (Cycle 2 and beyond)","description":"ULN=upper level of normal. Alkaline phosphatase (ALP) Gr 1:>ULN to 2.5*ULN, Gr 2: >2.5 to 5.0*ULN, Gr 3: >5.0 to 20.0*ULN, Gr 4: >20.0*ULN; Aspartate aminotransferase (AST) Gr 1: >ULN to 2.5*ULN, Gr 2: >2.5 to 5.0*ULN, Gr 3: >5.0 to 20.0*ULN, Gr 4: >20.0*ULN"},{"outcome_type":"secondary","measure":"Median Length of Survival in the Overall Population and in the Subgroups of Patients With βIII-tubulin Positive (β3T+) and βIII-tubulin Negative (β3T-)Tumors","time_frame":"Randomization to death or last known alive date, up to 31.34 months","description":"Overall Survival was computed for all randomized participants and was defined as the time between randomization and death. Participants who did not die at the end of the study were censored at their last known alive date."}]}
{"nct_id":"NCT02066493","start_date":"2008-12-05","enrollment":362,"brief_title":"Giant Intracranial Aneurysm Registry","official_title":"Giant Intracranial Aneurysm Registry","primary_completion_date":"2022-09-30","study_type":"Observational [Patient Registry]","rec_status":"Active, not recruiting","completion_date":"2022-09-30","last_update":"2018-01-11","description":"The purpose of this study is to generate detailed insight into which therapies of giant intracranial aneurysms are being conducted, to document the natural history and the outcome of treatment over 5 years after inclusion into the Registry and to follow imaging data of giant aneurysms over years after diagnosis.","other_id":"Giant","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"primary care clinic","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  diagnosis of a giant intracranial aneurysm\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  age younger than 18\r\n      ","sponsor":"Dr. med. Julius Dengler","sponsor_type":"Other","conditions":"Intracranial Aneurysms","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"aneurysm rupture rate - diagnosed radiologically (e.g. by CT) or clinically","time_frame":"5 years"},{"outcome_type":"secondary","measure":"health status of the patient quantified by modified Rankin Scale in combination with a basic neurological exam","time_frame":"5 years"}]}
{"nct_id":"NCT00788372","start_date":"2008-11-30","phase":"Phase 3","enrollment":142,"brief_title":"An Efficacy and Safety Study of Fentanyl in Participants With Chronic Pain","official_title":"A Long-Term Study of JNS020QD in Patients With Chronic Pain","primary_completion_date":"2010-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-11-30","last_update":"2013-06-26","description":"The purpose of this study is to evaluate the safety and efficacy of fentanyl one-day transdermal patch (JNS020QD, patch containing a drug that is put on the skin so the drug will enter the body through the skin) in participants with chronic (lasting a long time) pain.","other_id":"CR015583","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Participants whose medication for chronic pain meets one of the criteria among a to e\r\n             (2 or more types of opioid analgesics must not be used): a) Participants who are\r\n             taking non-opioid analgesic at the normal highest dose or more for at least 14\r\n             consecutive days during 12 weeks before the informed consent, but were not\r\n             continuously taking the non-opioid analgesic during 14 days before the informed\r\n             consent for medical reasons such as safety b) Participants who are continuously taking\r\n             an additional analgesic with a certain dosage and administration for at least 14\r\n             consecutive days before the informed consent c)Participants who are continuously\r\n             taking codeine phosphate or dihydrocodeine phosphate less than 270 milligram (mg)\r\n             daily (except for rescue treatment) for at least 14 consecutive days before the\r\n             informed consent d) Participants who are continuously taking codeine morphine\r\n             hydrochloride of oral morphine equivalent dose of less than 45 mg daily (except for\r\n             rescue treatment) for at least 14 consecutive days before the informed consent (less\r\n             than 30 mg daily for suppositories and less than 15 mg daily for injections) e)\r\n             Participants who are continuously taking fentanyl citrate injection of less than 0.3\r\n             mg daily (except for rescue treatment) for at least 14 consecutive days before the\r\n             informed consent\r\n\r\n          -  Participants with chronic pain continuing for at least 12 weeks before informed\r\n             consent\r\n\r\n          -  Participants with an average pain intensity of greater than or equal to 50 millimeter\r\n             (mm) on the Visual Analog Scale in 24-hour daily living before informed consent\r\n\r\n          -  Participants who can be hospitalized to the 4th day after the initiation of patch\r\n             application\r\n\r\n          -  Participants who were given a sufficient explanation about the investigational product\r\n             and the study and gave their own consent to participate in the study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Participants whose main cause of the pain to be assessed is considered attributable to\r\n             psychogenic pain\r\n\r\n          -  Participants with severe respiratory function disorders\r\n\r\n          -  Participants with asthma (breathing disorder in which there is wheezing and difficulty\r\n             breathing) and bradyarrhythmia (slow, irregular heartbeats)\r\n\r\n          -  Participants with hepatic dysfunction function such as fulminant hepatitis\r\n             (inflammation of the liver) and liver cirrhosis (serious liver disorder in which\r\n             connective tissue replaces normal liver tissue, and liver failure often occurs), or\r\n             renal impairment such as nephritic syndrome, acute renal failure, and chronic renal\r\n             failure\r\n\r\n          -  Participants with organic disorder in the brain such as brain tumor who have any of\r\n             these symptoms: intracranial pressure increased, consciousness disturbance or coma and\r\n             respiratory disorder\r\n      ","sponsor":"Janssen Pharmaceutical K.K.","sponsor_type":"Industry","conditions":"Chronic Pain","interventions":[{"intervention_type":"Drug","name":"Drug: Fentanyl","description":"Fentanyl transdermal patch will be applied daily starting at a dose of 12.5 mcg/hr, and up to 52 weeks. Dose will be increased as per Investigator's discretion."}],"outcomes":[{"outcome_type":"primary","measure":"Questionnaire of Opioid Withdrawal Symptoms","time_frame":"Week 52 or endpoint (1 week after last treatment or early discontinuation)","description":"Questionnaire of opioid withdrawal symptoms is a clinician rated 11-item scale that primarily evaluates the physical components of opioid withdrawal and is based on questions and clinical observations. The total score of questionnaire of opioid withdrawal symptoms is the sum of all individual items, with less than (<) 5 points = no withdrawal, 5 to 12 points = mild withdrawal, 13 to 24 points = moderate withdrawal, 25 to 36 points = moderately severe withdrawal and greater than (>) 36 points = severe withdrawal."},{"outcome_type":"primary","measure":"Dependence Questionnaire (DQ)","time_frame":"Week 52 or end point (early discontinuation)","description":"The DQ is a clinician rated 5-item scale that evaluates dependence on drug and based on questions (Q). Based on participant's answer to Q in questionnaire, Investigator assessed whether drug dependence occurred. It comprises 5 Q which are: continuing drug for reason other than pain, using drug in more dosage than prescribed to have effect other than treatment of pain, have ever used drug with more dosage than prescribed for other purpose, anxiety with the thought of stopping drug for reason other than aggravation of symptoms by stopping this drug and feeling to violate law to get this drug."},{"outcome_type":"primary","measure":"Pain Visual Analogue Scale Score","time_frame":"Week 52 or end point (early discontinuation)","description":"Pain visual analog scale was used to assess the amount of pain experienced by the participant throughout the day by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from \"no pain (0 mm)\" to \"worst possible pain (100 mm)\"."},{"outcome_type":"primary","measure":"Number of Participants With Pain Assessed by Categorical Scale for Pain","time_frame":"Week 52 or final evaluation (early discontinuation)","description":"Pain intensity was measured by assessing the average intensity of pain experienced by the participant in daily living throughout the day by 4 grades: no pain at all, mild (slightly painful, but not worried), moderate (painful, but bearable) and severe (painful and unbearable)."},{"outcome_type":"primary","measure":"Number of Participants With Total Painful Time Per Day","time_frame":"Week 52 or final evaluation (early discontinuation)","description":"The participants assessed total painful time in 1 day by the following 5 grades: less than 4 hours, 4 hours to less than 8 hours, 8 hours to less than 12 hours, 12 hours or more and all day."},{"outcome_type":"primary","measure":"Number of Participants With Quality of Sleep","time_frame":"Week 52 or final evaluation (early discontinuation)","description":"The quality of sleep was assessed by participants that how well they have slept from the previous assessment to current assessment time by the following 4 grades: can sleep well, can sleep moderately well, cannot sleep much and cannot sleep at all."},{"outcome_type":"primary","measure":"Number of Rescue Treatments","time_frame":"Week 52 or final evaluation (early discontinuation)","description":"Rescue treatment was used for participants with lack of analgesic efficacy, to have relief from breakthrough pain and in cases where withdrawal symptoms occur. The reference one-time rescue dose used was oral morphine 5 milligram (mg) for the investigational product fentanyl one-day transdermal patch 12.5 mcg per hr. The number of rescue treatments per day were reported."},{"outcome_type":"primary","measure":"Short-Form 36-Item Health Survey (SF-36) Scores","time_frame":"Week 52 or final evaluation (early discontinuation)","description":"The SF-36 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state."},{"outcome_type":"primary","measure":"Physician's Global Assessment Scale","time_frame":"Week 52 or final evaluation (early discontinuation)","description":"The treating physician assessed the therapeutic efficacy of the treatment by 2 grades: effective and ineffective. Numbers of participants with effective and ineffective therapeutic efficacy with the treatment were reported."},{"outcome_type":"primary","measure":"Participants Overall Assessment","time_frame":"Week 52 or final evaluation (early discontinuation)","description":"The participants assessed their satisfaction with therapeutic efficacy by 5 grades: satisfied very much, satisfied, equivocal, dissatisfied and dissatisfied very much. Percentage of participants who were at least satisfied (satisfied, satisfied very much) or at least neither satisfied nor dissatisfied (dissatisfied, dissatisfied very much) were reported."},{"outcome_type":"primary","measure":"Brief Pain Inventory-Short Form (BPI-SF) Total Score","time_frame":"Week 52 or final evaluation (early discontinuation)","description":"The BPI-SF is a self-report questionnaire designed to assess the severity and impact of pain on daily functions. It includes pain interference score which is mean value for scores for 9 BPI-SF questions ranging between 0 (does not interfere) to 10 (completely interferes) and pain subscale score which is mean value for scores for BPI-SF questions 3 to 6 ranging between 0 (no pain) to 10 (pain as bad as can imagine). Total BPI-SF score is an average of pain interference score and pain subscale score and ranges from 0 to 10; higher score indicates more pain or pain interference."}]}
{"nct_id":"NCT00803959","start_date":"2008-11-30","phase":"Phase 4","enrollment":630,"brief_title":"Value of Urodynamic Evaluation","official_title":"A Randomized Trial of Urodynamic Testing Before Stress-Incontinence Surgery","primary_completion_date":"2009-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-06-30","last_update":"2013-08-06","description":"Although no reliable and specific figures are available for the total expenditure on UDS, UDS is commonly performed for patients with urinary incontinence (UI) regardless of gender and age. UDS is typically performed prior to incontinence surgery. Urodynamic studies are expensive, time-consuming, and uncomfortable diagnostic investigations. The 3rd ICI reported insufficient evidence with which to answer the following key research questions related to UDS: 1) Do physicians alter clinical decision-making based on results of UDS?, and 2) Do alterations in clinical decisions made in response to UDS results improve the clinical outcomes?","other_id":"ValUE (completed)","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":21,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Female\r\n\r\n          2. Predominant SUI as evidenced by all of the following:\r\n\r\n               1. Self-reported stress-type UI symptoms, of duration >3 months*\r\n\r\n               2. MESA stress symptom score (percent of total possible stress score) greater than\r\n                  MESA urge symptom score (percent of total possible urge score)\r\n\r\n          3. Observation of leakage by provocative stress test at any volume\r\n\r\n          4. Eligible for randomization to either treatment group\r\n\r\n          5. Eligible for SUI surgery\r\n\r\n          6. Desires non-conservative therapy for SUI\r\n\r\n          7. PVR <150ml by any method. (May repeat once if initial measure is abnormal)\r\n\r\n          8. Negative urine dipstick (negative result = trace or less for leukocytes & nitrites) or\r\n             negative UA or negative culture\r\n\r\n          9. Available to initiate SUI treatment within 6 weeks of randomization\r\n\r\n         10. Available for 12-months of follow-up and able to complete study assessments, per\r\n             clinician judgment.\r\n\r\n         11. Signed consent form.\r\n\r\n               -  Patient can be rescreened after respective time interval has been met.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Age <21 years*\r\n\r\n          2. Currently undergoing or has had recommended treatment of apical or anterior prolapse\r\n\r\n          3. No anterior or apical prolapse > +1 on standing straining prolapse exam\r\n\r\n          4. Pregnant or has not completed child bearing.\r\n\r\n          5. <12 months post-partum*\r\n\r\n          6. Active malignancy of cervix, uterus, fallopian tube(s) or ovary > Stage I, or bladder\r\n             of any Stage\r\n\r\n          7. History of pelvic radiation therapy\r\n\r\n          8. Previous incontinence surgery\r\n\r\n          9. Current catheter use\r\n\r\n         10. Neurological disease known to affect bladder storage (e.g. MS, Parkinsonism, CVA)\r\n\r\n         11. Previous (i.e. repaired) or current urethral diverticulum\r\n\r\n         12. Prior augmentation cystoplasty or artificial sphincter\r\n\r\n         13. Implanted nerve stimulators for urinary symptoms or previous botox bladder injections.\r\n\r\n         14. Any pelvic surgery within the last 3 months*\r\n\r\n         15. Previous placement of synthetic mesh on a vaginal approach in the anterior compartment\r\n\r\n         16. Participation in another treatment intervention trial that might influence results of\r\n             this trial.\r\n\r\n         17. A urodynamic result reviewed by the investigator in the preceding 12 months or any\r\n             recollection by the investigator of urodynamic results on that subject.\r\n\r\n               -  Patient can be rescreened after respective time interval has been met.\r\n\r\n                    -  \"Partum\" is defined as a delivery or other termination that occurs after 20\r\n                       weeks gestation.\r\n      ","sponsor":"HealthCore-NERI","sponsor_type":"Other","conditions":"Urinary Incontinence","interventions":[{"intervention_type":"Other","name":"Other: UDS","description":"Urodynamics"},{"intervention_type":"Other","name":"Other: Office evaluation","description":"Office evaluation"}],"outcomes":[{"outcome_type":"primary","measure":"Self-reported Urinary Incontinence, Irritative and Obstructive Symptoms: Reduction of 70%+ in the Urogenital Distress Inventory From Baseline to 12 Mos and \"Very Much\" or \"Much\" Better on the Patient Global Impression of Improvement Measure at 12 Mos.","time_frame":"12 Months","description":"Treatment success is defined as a reduction in the Urogenital Distress Inventory score from baseline to 12 months of 70% or more and a Patient Global Impression of Improvement response of \"very much better\" or \"much better\" at 12 months."},{"outcome_type":"secondary","measure":"Percentage Meeting or Exceeding 70% Decrease in UDI Score Between Baseline and 12 Months","time_frame":"Baseline, 12 mos","description":"The Urogenital Distress Inventory is a 20-item patient-reported measure that assesses the presence of urinary incontinence, urgency, frequency, and voiding dysfunction and the extent to which the patient is bothered by these symptoms. Scores range from 0 to 300, with higher scores indicating greater distress. The 70% cutoff value was selected on the basis of the previous experience of the study investigators and receiver-operating- characteristic curve analyses from a previous surgical trial."},{"outcome_type":"secondary","measure":"Patient Global Impression Index","time_frame":"12 Months","description":"Patient Global Impression of Improvement is a patient-reported measure of perceived improvement that is obtained by asking study participants, \"How is your urinary tract condition now, as compared with how it was before you received treatment for your urinary leakage?\" Responses are on a 7-point scale from 1 meaning \"very much better\" to 7 meaning \"very much worse.\" Values of \"very much better\" (1) or \"much better\" (2) were considered to have \"perceived improvement\" according to this criteria. Values of 3 or greater were not (e.g. \"a little better\", \"no change\", \"a little worse\", \"much worse\" or \"very much worse\"). This instrument correlates with the frequency of incontinence episodes, pad tests, and quality of life as it relates to incontinence."},{"outcome_type":"secondary","measure":"Change in Bother as Measured by the UDI","time_frame":"Baseline, 12 Months","description":"The Urogenital Distress Inventory is a 20-item patient-reported measure that assesses the presence of urinary incontinence, urgency, frequency, and voiding dysfunction and the extent to which the patient is bothered by these symptoms. Scores range from 0 to 300, with higher scores indicating greater distress. Change was calculated as the score at 12 months minus the score at baseline. Higher scores indicate worse function, so the larger the negative value, the greater the improvement."},{"outcome_type":"secondary","measure":"Change in Severity as Measured by the ISI","time_frame":"Baseline & 12 Months","description":"Incontinence Severity Index has scores ranging from 1 to 12 and higher scores indicating greater severity. Change was calculated as the score at 12 months minus the score at baseline. Higher scores indicate worse function, so the larger the negative value, the greater the improvement."},{"outcome_type":"secondary","measure":"Change in MESA Stress Score","time_frame":"Screen & 12 Months","description":"The Medical, Epidemiological, and Social Aspects of Aging (MESA) stress score was measured at baseline and the 12 month visit with a possible range from 0 to 100 with higher scores indicating worse function. The outcome measures is change from baseline to 12 mo visit in MESA stress score. Change was calculated as the score at 12 months minus the score at baseline and could range from -100 to 100. Higher raw scores indicate worse function, so the larger the negative change score value, the greater the improvement."},{"outcome_type":"secondary","measure":"Change in MESA Urge Score","time_frame":"Screen & 12 Months","description":"The Medical, Epidemiological, and Social Aspects of Aging (MESA) urge score was measured at baseline and the 12 month visit with a possible range from 0 to 100 with higher scores indicating worse function. The outcome measures is change from baseline to 12 mo visit in MESA urge score. Change was calculated as the score at 12 months minus the score at baseline and could range from -100 to 100. Higher raw scores indicate worse function, so the larger the negative change score value, the greater the improvement."},{"outcome_type":"secondary","measure":"Change in Quality of Life as Measured by the IIQ","time_frame":"Baseline, 12 Months","description":"Incontinence Impact Questionnaire has scores ranging from 0 to 400 and higher scores indicating a more negative effect on quality of life. Change was calculated as the score at 12 months minus the score at baseline and scores could range from -400 to 400. Higher scores indicate worse function, so the larger the negative value, the greater the improvement."},{"outcome_type":"secondary","measure":"Change in Quality of Life as Measured by the SF-12","time_frame":"Baseline, 12 Months","description":"The Medical Outcomes Study 12-Item Short Form Health Survey has scores ranging from 0 to 200 and higher scores indicating better health. Change was calculated as the score at 12 months minus the score at baseline and could range from -200 to 200. The larger the positive value, the greater the improvement."},{"outcome_type":"secondary","measure":"Change in Severity as Measured by the PGI-S","time_frame":"Baseline & 12 Months","description":"The Patient Global Impression of Severity has scores ranging from 1 [normal] to 4 [severe]. Change was calculated as the score at 12 months minus the score at baseline and could range from -3 to 3. Higher scores indicate worse function, so the larger the negative value, the greater the improvement."},{"outcome_type":"secondary","measure":"Moderate or Severe Severity as Measured by the PGI-S","time_frame":"12 Months","description":"The Patient Global Impression of Severity (PGI-S) has scores ranging from 1 [normal] to 4 [severe]. This measure is the percentage of participants responding to the PGI-S with a \"3\" corresponding to the \"moderate\" category or a \"4\" corresponding to the \"severe\" category at the 12 month visit."},{"outcome_type":"secondary","measure":"Patient Satisfaction With Treatment Outcome","time_frame":"12 Months","description":"A summary score for patient satisfaction was based on responses to questions developed for this study with scores ranging from 0 to 100 and higher scores indicating better satisfaction."},{"outcome_type":"secondary","measure":"Stress Test at 12 Mos","time_frame":"Screen and 12 months","description":"A provocative stress test at a bladder volume of 300 ml was performed for direct observation of urine leakage. Observed urine loss from the urethra coincidental with the Valsalva maneuver or cough was considered a positive test. The stress test was not performed by the study surgeon but rather by an outcome assessor who was unaware of the study assignments."}]}
{"nct_id":"NCT00728624","start_date":"2008-11-30","enrollment":2039,"brief_title":"Assessing Prevalence Of Beta Lactamase Production From Clinical Isolates Of Hospitalized Patients And Comparison Of Antibiotic Susceptibility Patterns","official_title":"Expert Group On Antibiotic Susceptibility Testing [EGAST] 2008: A Non-Interventional, Multicenter In-Vitro Study To Evaluate The Prevalence Of Beta-Lactamase Producing Strains Among Clinical Isolates Obtained From Hospital In-Patients And Comparison Of Antimicrobial Susceptibility Using Disc-Diffusion Method","primary_completion_date":"2009-09-30","study_type":"Observational","rec_status":"Completed","completion_date":"2009-09-30","last_update":"2017-03-10","description":"EGAST 2008 is a prospective, non interventional, multicentric study (approximately 2000 isolates from 15- 20 sites). Objectives: - Comparison of antimicrobial susceptibility using disc-diffusion method - Assessing prevalence of beta-lactamase producing strains among clinical isolates obtained from hospital in-patients","other_id":"A1891005","observational_model":"Other","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","population":"Isolates from hospitalised patients","criteria":"\n        Inclusion Criteria:\r\n\r\n        Isolates (as specified in the observational plan) from hospitalised patients\r\n\r\n        Exclusion Criteria:\r\n\r\n        Isolates obtained from outpatients will not be included for the study. Isolates from repeat\r\n        cultures performed during in-patient follow-up that were previously recruited into the\r\n        study will be excluded.\r\n\r\n        Isolates identified as commensals or contaminants will be excluded\r\n      ","sponsor":"Pfizer","sponsor_type":"Industry","conditions":"Infection","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Comparison of antimicrobial susceptibility using disc-diffusion method","time_frame":"duration of trial"},{"outcome_type":"secondary","measure":"Assessing prevalence of beta-lactamase producing strains among clinical isolates obtained from hospital in-patients","time_frame":"duration of trial"}]}
{"nct_id":"NCT01223300","start_date":"2008-11-30","enrollment":12,"brief_title":"Osteoporosis Research Registry","official_title":"Osteoporosis Research Registry","primary_completion_date":"2016-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2016-12-31","last_update":"2016-12-19","description":"The aim of this research registry is to collect information on individuals with osteoporosis, those with risk factors for osteoporosis, and comparative healthy controls. Bone mineral density measurements will be done on these individuals to determine bone health.","other_id":"STU00007523","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","population":"Individuals with osteoporosis or at risk for osteoporosis. Also, healthy controls.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Any subjects who give written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any individual who is not willing or able to give written informed consent\r\n      ","sponsor":"Northwestern University","sponsor_type":"Other","conditions":"Osteoporosis","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"BMD","time_frame":"0 months"},{"outcome_type":"secondary","measure":"Bone markers","time_frame":"0 months"}]}
{"nct_id":"NCT00762775","start_date":"2008-11-30","phase":"N/A","enrollment":78,"brief_title":"The Interaction Between Calcium and Vitamin D Intake","official_title":"The Interaction Between Calcium and Vitamin D Intake","primary_completion_date":"2011-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-06-30","last_update":"2014-12-11","description":"We will study the relative importance of high calcium intake and vitamin D supplementation for calcium homeostasis, as determined by serum parathyroid hormone (PTH) and biochemical bone markers. We also intend to examine the interaction of vitamin D and calcium intake on calcium homeostasis. We hypothesize that optimal calcium supplementation and optimal vitamin D supplementation will lead to lower serum levels of PTH and markers of bone resorption compared with the placebo. We also theorize that when taken together, optimal calcium supplementation and optimal vitamin D intake will result in lower serum levels of PTH and bone markers compared with calcium or vitamin D taken alone.","other_id":"33497","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"Female","minimum_age":45,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy women aged 45 and above who have been menopausal at least 1 year (absence of\r\n             menstrual period for a period of 12 months or more)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any chronic medical illness including uncontrolled diabetes mellitus, recent history\r\n             of myocardial infarction, or heart failure, malignancy, uncontrolled hypertension,\r\n             obesity (BMI>35 kg/m2), history of anemia, leukemia, or other hematologic\r\n             abnormalities, lupus, rheumatoid arthritis, or other rheumatologic disease, or kidney\r\n             disease of any kind as determined by history and physical examination.\r\n\r\n          -  Subjects with osteoporosis of the hip (total hip T-score equal or less than -2.5) or\r\n             taking medications for osteoporosis such as bisphosphonates will be excluded.\r\n\r\n          -  Pregnancy.\r\n\r\n          -  Use of medication that influences bone metabolism (i.e. anticonvulsant medications,\r\n             chronic use of steroids and high dose diuretics).\r\n\r\n          -  Significant deviation from normal in medical history, physical examination, or\r\n             laboratory tests as evaluated by the primary investigator.\r\n\r\n          -  Patients with a history of hypercalciuria, hypercalcemia, nephrolithiasis, and active\r\n             sarcoidosis will also be excluded.\r\n\r\n          -  Participation in another investigational trial in the past 30 days prior to the\r\n             screening evaluation.\r\n\r\n          -  Unexplained weight loss of >15% during the previous year or history of anorexia\r\n             nervosa.\r\n\r\n          -  Medications that interfere with vitamin D metabolism.\r\n\r\n          -  Patients with a habitual dietary calcium intake that exceeds 800 mg/day.\r\n\r\n          -  Smokers greater than 1 pack per day will be excluded.\r\n\r\n          -  Patients reporting alcohol intake greater than 2 drinks daily.\r\n\r\n          -  Serum 25-hydroxyvitamin D level > 75 nmol/L.\r\n      ","sponsor":"Winthrop University Hospital","sponsor_type":"Other","conditions":"Osteoporosis","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Calcium and vitamin D supplementation","description":"Arm 1: 1,200 mg daily of calcium supplementation and placebo; Arm 2: 100 microgram daily of Vitamin D and placebo; Arm 3: 1,200 mg of calcium and 100 microgram of Vitamin D daily; Arm 4: placebos only."}],"outcomes":[{"outcome_type":"primary","measure":"The influence of calcium supplementation alone on serum PTH levels and bone markers in healthy adult women.","time_frame":"6 months"},{"outcome_type":"secondary","measure":"The interaction between calcium and vitamin D supplementation and their combined effect on serum PTH hormone levels and bone markers in healthy adult women.","time_frame":"6 months"}]}
{"nct_id":"NCT01098838","start_date":"2008-11-30","phase":"Phase 1","enrollment":71,"brief_title":"Safety and Efficacy of LCL161 in Patients With Solid Tumors","official_title":"A Phase I, Multi-center, Open-label, Dose-escalation Study of Oral LCL161 in Adult Patients With Advanced Solid Tumors","primary_completion_date":"2011-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-01-31","last_update":"2012-08-03","description":"The study will evaluate the safety of increasing doses of oral LCL161 in patients with solid tumors. It is primarily designed to evaluate the side effects and find the maximum tolerated dose of LCL161.","other_id":"CLCL161A2101","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Solid tumor\r\n\r\n          -  ECOG performance status 0-2\r\n\r\n          -  Life expectancy greater than or equal to 12 weeks\r\n\r\n          -  Must meet certain blood laboratory values\r\n\r\n          -  Must meet criteria for time since the last dose of prior therapy\r\n\r\n          -  Must provide written informed consent to participate in this study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Active and/or symptomatic brain tumors or brain metastases.\r\n\r\n          -  Patients with unresolved nausea, vomiting, or diarrhea\r\n\r\n          -  Any ongoing severe and/or uncontrolled medical condition that could compromise\r\n             participation in the study including heart, lung or inflammatory disease\r\n\r\n          -  Any disease that may significantly alter the absorption of the study drug (for\r\n             example, ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption\r\n             syndrome, or removal of small bowel)\r\n\r\n          -  Patients who are currently receiving treatment with steroids at a certain dose or\r\n             other immunosuppressive treatment that cannot be stopped prior to starting study drug\r\n\r\n          -  Patients who are currently receiving treatment with certain medications\r\n\r\n          -  Patients who have received radiation therapy or have undergone major surgery within\r\n             the last 4 weeks\r\n\r\n          -  Women of child-bearing potential who are pregnant or breast feeding.\r\n\r\n          -  Known diagnosis of human immunodeficiency virus (HIV) infection or chronic active\r\n             hepatitis B or C\r\n\r\n          -  Patients unwilling or unable to follow the protocol\r\n\r\n        Other protocol-defined inclusion/exclusion criteria may apply\r\n      ","sponsor":"Novartis Pharmaceuticals","sponsor_type":"Industry","conditions":"Advanced Solid Tumors","interventions":[{"intervention_type":"Drug","name":"Drug: LCL161"}],"outcomes":[{"outcome_type":"primary","measure":"Occurrence of dose-limiting toxicities","time_frame":"Cycle 1"},{"outcome_type":"secondary","measure":"Frequency and type of adverse events","time_frame":"throughout the study"},{"outcome_type":"secondary","measure":"Comparison of amount of LCL161 that gets into blood stream from tablet formulation versus liquid formulation (bioavailability)","time_frame":"3 months"},{"outcome_type":"secondary","measure":"Blood assessments to determine how much LCL161 gets into the blood stream (pharmacokinetic parameters)","time_frame":"4 weeks"},{"outcome_type":"secondary","measure":"Pharmacodynamic measurements to determine how LCL161 interacts with proteins related to cancer such as cIAP, cytokines, and cell death markers; hair, skin and tumor samples will be evaluated for target inhibition","time_frame":"Intermittent throughout treatment period"},{"outcome_type":"secondary","measure":"Solid tumor response criteria will be used to identify any anti-tumor activity","time_frame":"After a minimum of 2 cycles"}]}
{"nct_id":"NCT01062854","start_date":"2008-11-30","phase":"N/A","enrollment":407,"brief_title":"Effects of Earplugs on Sleep and Sleep Apnea","official_title":"Effects of Earplugs on Sleep and Sleep Apnea","primary_completion_date":"2010-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-08-31","last_update":"2016-12-06","description":"The main goal of this study is to assess whether use of earplugs has any effect on sleep, sleep apnea, and daytime sleepiness in individuals who snore.","other_id":"HUM00023548","allocation":"Randomized","intervention_model":"Parallel Assignment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adults, ages 18 or older\r\n\r\n          -  Scheduled at the University of Michigan Sleep Disorders Center for a diagnostic\r\n             polysomnogram to evaluate for sleep-disordered breathing\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Medical, psychiatric or other conditions that would interfere with interpretation of\r\n             the results of the sleep studies or the subject's ability to complete the Stanford\r\n             Sleepiness Scale\r\n      ","sponsor":"University of Michigan","sponsor_type":"Other","conditions":"Sleep Disordered Breathing","interventions":[{"intervention_type":"Other","name":"Other: Soft earplugs are worn during sleep study","description":"Subjects are asked to wear earplugs when possible for 3-5 nights prior to their baseline sleep study. On the night of their sleep study they are randomized to either \"wears earplugs\" or \"no earplugs\" groups."}],"outcomes":[{"outcome_type":"primary","measure":"Sleep measures (rates of apneas and hypopneas, oxygen desaturation, arousals, sleep stages, respiratory cycle-related EEG changes [RCREC])","time_frame":"up to 2 years after the sleep study"},{"outcome_type":"secondary","measure":"Subjective sleepiness measures (Stanford Sleepiness Scale)","time_frame":"on awakening after the sleep study"}]}
{"nct_id":"NCT00732108","start_date":"2008-11-30","phase":"N/A","enrollment":0,"brief_title":"Is Topiramate Effective in Treating Dizziness in Patient's With Migraine-Associated Dizziness","official_title":"Efficacy of Topiramate in Patients Wih Migraine-Associated Dizziness","primary_completion_date":"2011-08-31","study_type":"Interventional","rec_status":"Withdrawn","last_update":"2015-03-06","description":"The purpose of this study is to determine whether topiramate effective in treating dizziness symptoms that are associated with migraine headaches.","other_id":"H48626-32352-01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Clinical diagnosis of migraine-associated dizziness.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Previous or current use of topiramate prior to study enrollment.\r\n\r\n          -  Need for continued use of the following medications for any medical reason during the\r\n             study: ergots, anti-epileptics, beta-blockers, calcium channel blockers, monoamine\r\n             oxidase inhibitors, high-dose magnesium, high-dose riboflavin, corticosteroids, local\r\n             anesthetics, botulinum toxin, or herbal preparations.\r\n\r\n          -  History of nephrolithiasis.\r\n\r\n          -  Women whom are pregnant or breastfeeding.\r\n\r\n          -  Patients with known sensitivity to topiramate.\r\n\r\n          -  Patients with a history of glaucoma.\r\n\r\n          -  Patients with severe medical condition(s) that in the view of the investigator\r\n             prohibits participation in the study.\r\n      ","sponsor":"University of California, San Francisco","sponsor_type":"Other","conditions":"Migraine|Headache|Dizziness","interventions":[{"intervention_type":"Drug","name":"Drug: topiramate","description":"50mg orally for 2 weeks, then 100mg orally for 6 weeks"},{"intervention_type":"Drug","name":"Drug: lactulose placebo pill","description":"1 placebo pill orally for 2 weeks, then 2 placebo pills orally for 6 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Change in mean 28-day monthly vertigo frequency from baseline.","time_frame":"4 weeks, 8 weeks"},{"outcome_type":"primary","measure":"Change in Dizziness Handicap Inventory scores from baseline.","time_frame":"4 weeks, 8 weeks"},{"outcome_type":"secondary","measure":"Change in an individual's perception of vertigo symptoms based on a 1 to 10 scale.","time_frame":"4 weeks, 8 weeks"}]}
{"nct_id":"NCT00767663","start_date":"2008-10-31","phase":"Phase 4","enrollment":30,"brief_title":"Persantin Preceding Elective PCI","official_title":"Does Pretreatment With Persantin Reduce Periprocedural Troponin-I Release in Patients Undergoing Elective Single Vessel PCI","primary_completion_date":"2010-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-02-28","last_update":"2015-10-30","description":"In this study the investigators will investigate whether a short pretreatment (3-7 days) with dipyridamole 200mg twice daily will protect patients against myocardial injury sustained during an elective dotter operation of the coronary arteries (PCI). The investigators hypothesize that dipyridamole can reduce myocardial injury sustained during elective PCI.","other_id":"P3","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients accepted for elective single, native vessel (left anterior descending, right\r\n             coronary artery or ramus circumflexus (LAD, RCA or RCX)) PCI in the RUNMC\r\n\r\n          -  Troponin-I < 0,20 mmol/L at screening\r\n\r\n          -  Signed Informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  unstable angina\r\n\r\n          -  recent myocardial infarction (STEMI or non-STEMI), during two weeks prior to inclusion\r\n\r\n          -  3-Vessel disease as seen on coronary angiogram\r\n\r\n          -  Stenotic lesion in main stem as seen on coronary angiogram\r\n\r\n          -  CABG in medical history\r\n\r\n          -  asthma (recurrent episodes of dyspnoea and wheezing, or usage of prescribed inhalation\r\n             medication: i.e. corticosteroids or B2-agonists)\r\n\r\n          -  Treatment with insulin\r\n\r\n          -  Use of prescribed oral anticoagulants (coumarin derivates)\r\n\r\n          -  Use of oral corticosteroids\r\n\r\n          -  Use of sulfonylurea derivates (glibenclamide, tolbutamide, gliclazide, glimepiride)\r\n\r\n          -  Use of heparin or low molecular weight heparin\r\n\r\n          -  Use of metformin\r\n\r\n          -  Use of dipyridamole\r\n\r\n          -  Chronic use of Non Steroid Anti-Inflammatory Drugs (NSAID's)\r\n      ","sponsor":"Radboud University","sponsor_type":"Other","conditions":"Coronary Heart Disease|Percutaneous Transluminal Coronary Angioplasty|Atherosclerosis","interventions":[{"intervention_type":"Drug","name":"Drug: dipyridamole","description":"dipyridamole slow release 200mg twice daily, minimal 3 days pretreatment"},{"intervention_type":"Drug","name":"Drug: placebo","description":"placebo twice daily, minimal three days pretreatment"}],"outcomes":[{"outcome_type":"primary","measure":"Cardiac troponin-I","time_frame":"before and 8 hours after PCI"},{"outcome_type":"secondary","measure":"Effect of pretreatment with dipyridamole 2x200mg on biomarkers reflecting vascular inflammation (hs-CRP, PLA2, PTX3, IL-6, adiponectin, MCP-1, MMP-9)","time_frame":"3 days treatment minimal"},{"outcome_type":"secondary","measure":"Effect of PCI on biomarkers reflecting vascular inflammation (hs-CRP, PLA2, PTX3, IL-6, adiponectin, MCP-1, MMP-9)","time_frame":"before and 8 hours after PCI"}]}
{"nct_id":"NCT01220882","start_date":"2008-10-31","phase":"N/A","enrollment":60,"brief_title":"Evaluation of Skeletal Maturity for Slipped Capital Femoral Epiphysis","official_title":"Skeletal Age Assessment From the Olecranon For Slipped Capital Femoral Epiphysis","primary_completion_date":"2015-07-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2015-12-31","last_update":"2013-12-25","description":"This study is being done for two reasons: 1) to evaluate growth problems in the hip in patients with Slipped Capital Femoral Epiphysis (SCFE) as they continue to grow into adults, and 2) to help doctors determine which patients are at risk for developing a SCFE on their opposite hip. Studies show that up to 60% of patients with a SCFE will go on to develop a SCFE on their other side. Being able to better determine which patients are at risk for developing a SCFE on the other side will help physicians better monitor patients with a history of a SCFE and perhaps treat them before they develop a SCFE on the opposite side. By studying the growth centers seen on X-rays of your child's legs and elbow, the investigators may be able to better predict which children with a SCFE are at risk for developing a SCFE on their opposite hip and potential growth problems as they continue to grow.","other_id":"0120080287","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":8,"maximum_age":16,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Slipped capital femoral epiphysis\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior Slipped capital femoral epiphysis not initially treated at our institution\r\n      ","sponsor":"Rutgers, The State University of New Jersey","sponsor_type":"Other","conditions":"Slipped Capital Femoral Epiphysis","interventions":[{"intervention_type":"Radiation","name":"Radiation: Radiographic skeletal age assessment","description":"bone age assessment from the elbow lateral radiograph"}],"outcomes":[{"outcome_type":"primary","measure":"Radiographic data on skeletal maturity and SCFE radiographic characteristics","time_frame":"Day 1","description":"Radiographic assessment on initial presentation of SCFE on hip and pelvis x-rays, limb length discrepancy on Scanogram, and bone age measurement using hand AP radiograph and lateral view of the elbow."},{"outcome_type":"secondary","measure":"Clinical examination","time_frame":"Year 8","description":"Skeletal maturity will be determined when the proximal femoral physis have both fused (approximately age 14 years for girls and 16 years for boys)."},{"outcome_type":"secondary","measure":"Radiographic evaluation of Limb length discrepancy on Scanogram","time_frame":"Year 8","description":"Skeletal maturity will be determined when the proximal femoral physis have both fused (approximately age 14 years for girls and 16 years for boys)."}]}
{"nct_id":"NCT00806910","start_date":"2008-10-31","phase":"Phase 4","enrollment":0,"brief_title":"Diuretic and Renal Effects of Vaprisol When Administered Along With Furosemide and Nesiritide Continuous Infusion","official_title":"Evaluation of the Diuretic and Renal Effects of Vaprisol When Administered Along With Furosemide and Nesiritide Continuous Infusion","primary_completion_date":"2010-02-28","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2010-02-28","last_update":"2011-06-23","description":"Heart Failure is a growing and challenging public health concern in the United States. Heart failure commonly manifests as a syndrome of salt and water retention. Arginine vasopressin is a peptide hormone that is intimately involved in salt and water homeostasis. AVP is released into the circulation in response low blood volume and hypernatraemia. Despite fluid overload, vasopressin levels are often inappropriately elevated in patients with heart failure and LV dysfunction. Data suggest that vasopressin may also contribute to the deleterious circulatory response in patients with heart failure and play a role in the development and progression of the disease process. In their study, Udelson et al. showed that vasopressin receptor antagonism with Conivaptan resulted in significant diuresis with stable hemodynamics in advanced heart failure patients. Currently Intravenous diuretics and vasodilators are the standard of care in treating patients with acute decompensated heart failure. We will be studying the renal and diuretic effects of add on therapy with intravenous Conivaptan in patients receiving intravenous Nesiritide and intravenous diuretics.","other_id":"HN-4040","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients over the age of 18 and able to consent\r\n\r\n          -  LVEF 40% (as measured within last 6 months before entering into the study)\r\n\r\n          -  Patients with Acute Decompensated Heart Failure (ADHF) (NYHA class 3 & 4)\r\n\r\n          -  Patients with estimated GFR >40ml/min as calculated by Cockcroft-Gault or MDRD formula\r\n\r\n          -  Serum Sodium level <135 meq/L\r\n\r\n          -  Ability to understand and willing to sign informed consent\r\n\r\n          -  Willingness to follow-up in the clinic as outpatient\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with Acute Coronary Syndrome (ACS: Unstable angina, NSTEMI or STEMI)\r\n\r\n          -  Patients on pressors (including Vasopressin analogs) for hemodynamic stability\r\n\r\n          -  Supine systolic blood pressure <100 mm Hg\r\n\r\n          -  Hypersensitivity to Conivaptan\r\n\r\n          -  Concomitant use of medications that affects hepatic drug metabolism (e.g.\r\n             Ketoconazole, Itraconazole, Ritonavir, Indinavir, Clarithromycin etc.)\r\n\r\n          -  Significant liver dysfunction (ALT & AST more than twice the upper limit of normal)\r\n\r\n          -  Uncontrolled bradyarrhythmias or tachyarrhythmias\r\n\r\n          -  Pacemaker or defibrillator implantation or other cardiac surgery <60 days\r\n\r\n          -  Severe obstructive pulmonary disease\r\n\r\n          -  Significant uncorrected valvular or congenital heart disease\r\n\r\n          -  Obstructive cardiomyopathy\r\n\r\n          -  Significant renal impairment (defined as a serum creatinine >2.5 mg/dL or creatinine\r\n             clearance <40 ml/min).\r\n\r\n          -  Radiocontrast infusion within <7 days\r\n\r\n          -  Pregnant or lactating female subject\r\n\r\n          -  Untreated severe hyperthyroidism, hypothyroidism or adrenal insufficiency\r\n\r\n          -  Expected requirement for emergent treatment of hypernatremia during the course of the\r\n             study\r\n\r\n          -  Known urinary outflow obstruction, unless subject is, or can be catheterized during\r\n             the study\r\n\r\n          -  Serum albumin < 1.5 gm/dl documented any time during any time during seven days prior\r\n             to study drug administration\r\n\r\n          -  Any concurrent illness, which in opinion of the investigator, may interfere with\r\n             treatment or evaluation of safety.\r\n\r\n          -  White blood cell count (WBC) count < 3000 /mL documented any time during seven days\r\n             prior to study drug administration or anticipated drop in WBC count <3000/mL during\r\n             the period of study due to chemotherapy.\r\n\r\n          -  Participation in another clinical trial of an investigational drug (including placebo)\r\n             or device within 30 days of screening for entry into the present study\r\n\r\n          -  Subject has moderate ascites on physical examination secondary to hepatic dysfunction\r\n             (ascites primarily related to cardiac dysfunction will be allowed as long as subject\r\n             does not have cardiac cirrhosis).\r\n\r\n          -  Subject has moderate to severe hepatic impairment as evidenced by Child-Pugh B or C\r\n             criteria.\r\n\r\n          -  Subject has a history of hepatic encephalopathy, hematemesis or melena.\r\n\r\n          -  Subjects with altered mental status due to severe hyponatremia.\r\n\r\n          -  Patient belonging to a vulnerable population such as institutionalized person,\r\n             prisoners and persons with decisional incapacity or dementia.\r\n\r\n          -  Patients on medications which are known to cause drug interactions such as\r\n             Nicardipine, lovastatin, Ritonovir, Doxorubicin Etc\r\n      ","sponsor":"Albert Einstein Healthcare Network","sponsor_type":"Other","conditions":"Heart Failure","interventions":[{"intervention_type":"Drug","name":"Drug: Conivaptan","description":"IV Vaprisol initially at 20 mg IV injection over 30 minutes, followed by a 20 mg IV infusion over the next 24 hours (i.e. 20 mg bolus, 20 mg continuous infusion approximately 24 hrs)."},{"intervention_type":"Other","name":"Other: Placebo","description":"Placebo (will be given at the same rate of Vaprisol given in the treatment arm)"}],"outcomes":[{"outcome_type":"primary","measure":"Degree of diuresis as measured by weight change and intake and output measurement","time_frame":"Post infusion, Pre discharge and at 30 day Post discharge"},{"outcome_type":"secondary","measure":"Length of stay (LOS) in hospital","time_frame":"Concurrent"},{"outcome_type":"secondary","measure":"Clinical status based on NYHA criteria","time_frame":"Pre-discharge and 30-day post-discharge follow up"},{"outcome_type":"secondary","measure":"Serum electrolytes","time_frame":"Pre and Post infusion"},{"outcome_type":"secondary","measure":"BUN and Serum Creatinine concentration","time_frame":"Post infusion, Pre discharge and at 30 day Post discharge"},{"outcome_type":"secondary","measure":"Number of readmissions due to ADHF","time_frame":"Within 30-day post-discharge follow up"},{"outcome_type":"secondary","measure":"Dyspnea assessment by Visual Analog Scale score","time_frame":"Post infusion, Pre discharge and at 30 day Post discharge"},{"outcome_type":"secondary","measure":"Subjective feeling based on Minnesota - Living with Heart Failure Questionnaire","time_frame":"Pre-discharge and 30-day post-discharge follow up"}]}
{"nct_id":"NCT01301937","start_date":"2008-10-31","phase":"Phase 2/Phase 3","enrollment":76,"brief_title":"Low Antimonial Dosage in American Mucosal Leishmaniasis","official_title":"Phase III Clinical Trial for Mucosal or Mucocutaneous Leishmaniasis. Comparison Between the Standard and Alternative Antimonial Schemes","primary_completion_date":"2020-12-31","study_type":"Interventional","rec_status":"Recruiting","completion_date":"2021-12-31","last_update":"2018-07-12","description":"\"Phase III clinical trial for mucosal or mucocutaneous leishmaniasis. Equivalence between the standard and alternative schemes with meglumine antimoniate\" has begun in October 2008 at the Laboratory of Leishmaniasis Surveillance at Evandro Chagas Clinical Research Institute (IPEC), FIOCRUZ, aiming to compare efficacy and safety of the standard recommended schedule with an alternative regimen of meglumine antimoniate (MA) in the treatment of mucosal or mucocutaneous leishmaniasis (ML or MCL)). It is a study with blind evaluation by the doctors and the responsible for statistical analysis. Patients diagnosed with Ml or MCL, eligible for the trial, are randomly allocated into one of the schemes with meglumine antimoniate and monitored before, during and after it. There is no single regimen applicable to all forms of leishmaniasis around the world. Therapeutic regimens applied to treat people living in other geographic areas result in mixed outcomes. Ideally, the most appropriate regimens should be established for each endemic area, based on its efficacy, toxicity, difficulties of administration and cost. Given the problems and limitations of the use of pentavalent antimonials at 20 mg / kg / day, a less toxic alternative regimen with 5mg/kg/day, continuous up to the cure deserves to be better evaluated. Treatment must lead to the healing of mucosal lesions and prevent late scarring tissues and disabilities development. The indication of high doses of MA is based on the evidence that there could be induction of resistance with use of subdoses. However, clinical studies with extended follow-up in Rio de Janeiro have suggested that regular low MA doses (5mg / kg / day) in a systemic way may constitute an effective scheme, achieving cure rates similar to higher dose, with lower toxicity, ease of implementation and lower cost. Published studies on efficacy and safety of alternative schemes with meglumine antimoniate failed to provide conclusive results, for various methodological biases. The need to compare the effectiveness and safety between treatment schemes with meglumine antimoniate currently recommended in Brazil for the treatment of ML or MCL and an alternative scheme with low dose of antimony is the motive for this study in Rio de Janeiro.","other_id":"low dosage ML","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":13,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Mucosal or mucocutaneous leishmaniasis with parasitological diagnosis by one or more\r\n             of the following methods: direct examination (imprint), histopathology, culture,\r\n             immunohistochemistry, or PCR.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Women who do not use contraceptives or do it badly\r\n\r\n          -  Pregnant women\r\n\r\n          -  Children under 13 years\r\n\r\n          -  Previous antimonial treatment for LM\r\n\r\n          -  Immunosuppressive therapy (steroids, cancer chemotherapy) or medicines for\r\n             tuberculosis or leprosy.\r\n\r\n          -  Presence of altered baseline clinical adverse effect level equivalent to > G3\r\n\r\n          -  Presence of altered basal laboratory adverse effect level equivalent to > G2\r\n\r\n          -  Presence of baseline electrocardiographic changes equivalent to an adverse effect\r\n             level > G4 and / or baseline QTc > 0.46 ms (equivalent to AE level G1)\r\n      ","sponsor":"Oswaldo Cruz Foundation","sponsor_type":"Other","conditions":"Mucosal Leishmaniasis|Mucocutaneous Leishmaniasis","interventions":[{"intervention_type":"Drug","name":"Drug: Meglumine antimoniate","description":"Meglumine antimoniate (Aventis, So Paulo, Brazil) is stored and ministered under actual conditions employed by the health services in Brazil. Each patient will be included in one of two treatment groups with meglumine antimoniate IM:\r\nHigh continuous dose: 20 mg/kg/day for 30 continuous days.\r\nLow continuous dose 5 mg/kg/day for up to 120 continuous days.\r\nThere will be no cross-over between the groups for the purpose of this study. The data from those patients who require permanent discontinuation of a scheme will be assessed in the group that were randomized, ie, by intention to treat\r\nArms: High continuous dose, Low continuous dose"}],"outcomes":[{"outcome_type":"primary","measure":"Efficacy of meglumine antimoniate in the treatment of mucosal leishmaniasis","time_frame":"6 years","description":"This study is designed to evaluate the efficacy of high and low doses of meglumine antimoniate in the treatment of mucosal or mucocutaneous leishmaniasis."},{"outcome_type":"secondary","measure":"Safety of meglumine antimoniate in the treatment of mucosal leishmaniasis","time_frame":"6 years","description":"This study is designed to evaluate the safety of hig and low doses of meglumine antimoniate in the treatment of mucosal or mucocutaneous leishmaniasis."}]}
{"nct_id":"NCT00790322","start_date":"2008-10-31","phase":"Phase 3","enrollment":130,"brief_title":"Efficacy and Safety Study of SBG vs Placebo in Head and Neck Cancer Patients Undergoing Radiation Therapy","official_title":"A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase III Clinical Study to Assess the Efficacy and Safety of SBG on Oral Mucositis in Head and Neck Cancer Patients Undergoing Radiation Therapy With or Without Chemotherapy","primary_completion_date":"2010-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-02-28","last_update":"2010-02-19","description":"The purpose of this study is to evaluate the efficacy and safety of SBG vs placebo on oral mucositis in head and neck cancer patients undergoing radiation therapy.","other_id":"SBG-2-03","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        -  Patients with a normal oral mucosa who is scheduled to receive radiation therapy for\r\n             their head and neck cancer will be enrolled into the study.\r\n\r\n          -  Patients with previous head and neck cancer and/or radiation therapy in the head and\r\n             neck area and history/clinical evidence of active significant acute or chronic\r\n             conditions that may compromise the ability to evaluate or interpret the effects of the\r\n             study treatment on mucositis will be excluded.\r\n      ","sponsor":"Biotec Pharmacon ASA","sponsor_type":"Industry","conditions":"Head and Neck Cancer|Oral Mucositis","interventions":[{"intervention_type":"Drug","name":"Drug: SBG","description":"Soluble beta-1,3/1,6-glucan is a solution for oral use"},{"intervention_type":"Other","name":"Other: Placebo","description":"Solution for oral use"}],"outcomes":[{"outcome_type":"primary","measure":"Compare the proportion of patients in the two arms who develop severe oral mucositis","time_frame":"During radiation therapy"}]}
{"nct_id":"NCT00723177","start_date":"2008-10-31","phase":"Phase 2","enrollment":30,"brief_title":"Phase IIa Study of AV411, a Glial Activation Inhibitor, for Opioid Withdrawal","official_title":"The Safety, Tolerability and Preliminary Efficacy of AV411, a Glial Activation Inhibitor, in Heroin Abusers Under Conditions of Morphine Maintenance and Withdrawal","primary_completion_date":"2010-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-06-30","last_update":"2016-12-05","description":"Repeated use and/or abuse of opioid medications is generally associated with a characteristic withdrawal syndrome that develops after cessation of drug administration. The present study is designed to evaluate the effectiveness of AV411 to alter opioid-induced withdrawal symptoms.","other_id":"#5725","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":21,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adults between the ages of 21 and 45\r\n\r\n          -  Current dependence on heroin according to (Diagnostic and Statistical Manual) DSM-IV\r\n             criteria\r\n\r\n          -  Non-treatment seeking\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Female participants who are currently pregnant or breastfeeding. Lack of effective\r\n             birth control 10 days before Study Day 1 (15 days prior to the first PET scan)\r\n\r\n          -  Self-reported use of methadone, buprenorphine, or levo-alpha-acetylmethadol (LAAM) in\r\n             the past 14 days\r\n\r\n          -  Participants who have a positive history of neurological illness (including epilepsy)\r\n             or those who have received anti-convulsant therapy during the past 5 years\r\n\r\n          -  Liver disease requiring medication or medical treatment, and/or aspartate or alanine\r\n             aminotransferase levels greater than 3 times the upper limit of normal\r\n\r\n          -  Gastrointestinal or renal disease that would significantly impair absorption,\r\n             metabolism or excretion of study drug, or require medication or medical treatment\r\n\r\n          -  Neurological or psychiatric disorders including psychosis, bipolar disorder, organic\r\n             brain disease, any seizure history or other disorders that require treatment or that\r\n             could make study compliance difficult\r\n\r\n          -  Positive tuberculosis (PPD) TB skin test along with a clinical history and chest X-ray\r\n             indicative of active tuberculosis. (Individuals who have a positive PPD test and have\r\n             a negative chest X-ray, are not symptomatic for tuberculosis, and do not require\r\n             anti-tuberculosis therapy will be eligible to participate. Participants will be asked\r\n             if they ever tested positive for tuberculosis. If so, they will not be given a PPD and\r\n             a chest X-ray and clinical history will be used for evaluation purposes).\r\n\r\n          -  Presence or positive history of severe medical illness or any cardiovascular disease\r\n             or heart abnormality, such as low hemoglobin (Hb < 13 g/dL in males, Hb < 11 g/dL in\r\n             females), or BP > 150/90.\r\n\r\n          -  Requirement for any of the following medications (current or within the past 4 weeks):\r\n             psychotropics (including sedative/hypnotics, antidepressants, neuroleptics),\r\n             anticonvulsants, antihypertensives, antiarrhythmics, or antiretroviral medications,.\r\n             Participants on any current psychoactive prescription medications will be excluded.\r\n\r\n          -  Current dependence (by DSM-IV criteria) on methadone, LAAM, or buprenorphine\r\n\r\n          -  Participants for whom detoxification is not \"clinically recommended\" such as those\r\n             with a significant history of overdose following detoxification\r\n\r\n          -  Participation in an investigational drug study within the past 3 months\r\n\r\n          -  Hypersensitivity to any of the medications used in this study\r\n\r\n          -  Participants who are positive for HIV or chronic active hepatitis\r\n\r\n          -  Metal implants or paramagnetic objects contained within the body which may interfere\r\n             with the MRI scan, as determined in consultation with a neuroradiologist and according\r\n             to the guidelines set forth in the following reference book commonly used by\r\n             neuroradiologists: \"Guide to MR procedures and metallic objects\" Shellock Frank G.,\r\n             Lippincott Williams & Wilkins Healthcare, Philadelphia, 2001.\r\n\r\n          -  Lifetime exposure to radiation in the workplace, or participation in nuclear medicine\r\n             procedures, including research protocols, in the past year\r\n\r\n          -  Positive Allen Test indicating lack of collateral blood flow to hand\r\n\r\n          -  History of Reynaud's syndrome\r\n      ","sponsor":"New York State Psychiatric Institute","sponsor_type":"Other","conditions":"Opioid-Related Disorders","interventions":[{"intervention_type":"Drug","name":"Drug: AV411","description":"Low (20 mg), and high dose (40 mg) of AV411 will be administered orally twice a day (BID) for two consecutive weeks"},{"intervention_type":"Drug","name":"Drug: Placebo (PCB)","description":"Placebo drug will be administered orally twice a day (BID) for two consecutive weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Subjective Opioid Withdrawal Scale Score (SOWS)","time_frame":"Measured at the end of each two-week maintenance period (i.e., Placebo, Low AV411, High AV411).","description":"Measures severity of opioid withdrawal in opioid dependent populations (0-64). Larger values indicate more severe withdrawal."},{"outcome_type":"secondary","measure":"The Effects of AV411 on the Analgesic Effects of Oxycodone.","time_frame":"Measured at the end of each AV411 of the three two-week maintenance periods","description":"The McGill Pain Questionnaire (Melzack, 1987) was used to assess pain experience immediately following the immersion of the hand in 4 degree Celsius water. Scores were added across all 15 items to generate a sum score, which ranged between 15 and 60. Larger scores indicate greater pain levels."}]}
{"nct_id":"NCT02031887","start_date":"2008-10-31","phase":"N/A","enrollment":430,"brief_title":"Effect of a Starter Formula With Synbiotics on Stool Microbiota in Infants After Normal or Caesarean Section Delivery","official_title":"Effect of a Starter Formula With Synbiotics on Stool Microbiota in Infants After Normal or Caesarean Section Delivery","primary_completion_date":"2013-02-28","study_type":"Interventional","rec_status":"Terminated","completion_date":"2013-10-31","last_update":"2014-01-09","description":"The primary objectives of this trial are: - to show differences in the colonization of the gastrointestinal tract with the bacteria Bifidobacterium sp. between infants born by normal or caesarean delivery, fed with the test or a control product - to investigate whether there is equivalence in growth between the four different groups of infant described above.","other_id":"07.19.INF","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"Quadruple","sampling_method":"","gender":"All","maximum_age":0.00822,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy newborn infant from HIV positive mother\r\n\r\n          -  Full term infant (more or equal to 37 weeks gestation; less or equal to 42 weeks\r\n             gestation)\r\n\r\n          -  Age of infant 3 days at the time of enrollment\r\n\r\n          -  Birth weight between 2500 and 4500 grams\r\n\r\n          -  Singleton birth\r\n\r\n          -  The infant's mother has elected to feed their child exclusively with a milk formula\r\n             from birth\r\n\r\n          -  Informed consent from the parent or legal guardian\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Congenital illness or malformation that may affect normal growth\r\n\r\n          -  Significant pre-natal and / or post-natal disease\r\n\r\n          -  Newborns who have received antibiotics during the first 3 days of life\r\n\r\n          -  Newborns whose parents / caregivers cannot be expected to comply with the study\r\n             protocol\r\n\r\n          -  Newborns currently participating in another clinical trial\r\n      ","sponsor":"Nestl","sponsor_type":"Industry","conditions":"Healthy Full Term Infants","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: formula with synbiotics"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: formula without synbiotics"}],"outcomes":[{"outcome_type":"secondary","measure":"body composition by DEXA","time_frame":"4 month and 12 month of life"},{"outcome_type":"secondary","measure":"Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic)","time_frame":"10 days, 1 month, 6 weeks, 3 month and 4 month of life"},{"outcome_type":"primary","measure":"differences in the colonization of the gastrointestinal tract with the bacteria Bifidobacterium sp. between infants born by normal or caesarean delivery, fed with the test or a control product","time_frame":"3 days, 10 days, 1 month, and 3 months of age of the infant"},{"outcome_type":"primary","measure":"• Mean weight gain (g/day)","time_frame":"over 112 days"}]}
{"nct_id":"NCT01288976","start_date":"2008-10-31","enrollment":721,"brief_title":"ACCESS-Europe A Two-Phase Observational Study of the MitraClip System in Europe","official_title":"ACCESS-Europe A Two-Phase Observational Study of the MitraClip System in Europe","primary_completion_date":"2012-06-30","study_type":"Observational","rec_status":"Completed","completion_date":"2012-08-31","last_update":"2018-11-07","description":"The MitraClip System enables the European physicians an alternative therapeutic option for patients with mitral regurgitation (MR). Therapeutic alternatives are open-heart cardiac surgery, and palliative medical therapy with or without device therapy. The study will observe the outcomes of patients treated with the MitraClip System throughout 12-months as compared to the outcomes of patients treated by alternative therapies.","other_id":"EU-0901","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","population":"Patients with Mitral Regurgitation","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Per the current approved labeling for the Conformity European (CE) Marked MitraClip\r\n             System.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Per the current approved labeling for the CE Marked MitraClip System.\r\n      ","sponsor":"Abbott Medical Devices","sponsor_type":"Industry","conditions":"Mitral Valve (MV) Regurgitation","interventions":[{"intervention_type":"Device","name":"Device: MitraClip","description":"The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets"},{"intervention_type":"Drug","name":"Drug: Medical Management","description":"The Non-Surgical Medically Managed Heart Failure (HF) Group consists of patients with mitral regurgitation (MR) in whom the MR is managed non-surgically based on standard hospital clinical practice. Patients with MR who receive a pacemaker, Implantable Cardiac Defibrillator (ICD) and/or Cardiac Resynchronization Therapy (CRT) treatments may be included"},{"intervention_type":"Procedure","name":"Procedure: Mitral Valve Surgery","description":"The Mitral Valve Surgery Group consists of patients with MR in whom the MR is managed surgically (repair or replacement) based on standard hospital clinical practice. Patients with concurrent coronary artery bypass grafting (CABG) or aortic/tricuspid valve or and other cardiac procedure except atrial fibrillation surgery are excluded."}],"outcomes":[{"outcome_type":"secondary","measure":"Kaplan-Meier Freedom From All-Cause Mortality","time_frame":"At 12 months"},{"outcome_type":"primary","measure":"MR Severity","time_frame":"At baseline","description":"MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.\r\nMR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups. The Medical Therapy & Mitral Valve Surgery comparator groups were followed & studied primarily from a health economic perspective. Availability of clinical outcomes at followup is limited & has not been validated. Clinical outcomes for the comparator groups will not be reported."},{"outcome_type":"primary","measure":"MR Severity","time_frame":"At 12 months","description":"MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.\r\nMR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups. The Medical Therapy & Mitral Valve Surgery comparator groups were followed & studied primarily from a health economic perspective. Availability of clinical outcomes at follow-up is limited & has not been validated. Clinical outcomes for the comparator groups will not be reported."},{"outcome_type":"secondary","measure":"Procedure Time","time_frame":"Day 0 (On the day of procedure)","description":"Procedure Time is defined as the time of start of the transseptal procedure to the time the Steerable Guide Catheter is removed."},{"outcome_type":"secondary","measure":"Contrast Volume","time_frame":"Day 0 (On the day of procedure)"},{"outcome_type":"secondary","measure":"Fluoroscopy Duration","time_frame":"Day 0 (On the day of procedure)"},{"outcome_type":"secondary","measure":"Number of MitraClip Devices Implanted","time_frame":"Day 0 (On the day of procedure)","description":"Physicians had the option of deploying more than 1 MitraClip device if a single device did not provide satisfactory MR reduction, and if the mitral valve area was large enough to allow multiple MitraClip devices to be placed without causing mitral stenosis."},{"outcome_type":"secondary","measure":"ICU and Hospital Stay","time_frame":"From the day of procedure throughout 12 months of study period","description":"ICU and hospital stay is defined as the mean duration of time that patients spent in the ICU (Intensive Care Unit)/ CCU (Cardiac Care Unit)/ PACU (Post-Anesthesia Care Unit) following the MitraClip procedure. This secondary outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups."},{"outcome_type":"secondary","measure":"Discharge Status and Facility","time_frame":"At discharge, an average of 7.7 days following the MitraClip procedure"},{"outcome_type":"secondary","measure":"Discharge MR Severity","time_frame":"At discharge, an average of 7.7 days following the MitraClip procedure"},{"outcome_type":"secondary","measure":"Kaplan-Meier Freedom From All-Cause Mortality","time_frame":"At 0 day"},{"outcome_type":"secondary","measure":"Kaplan-Meier Freedom From All-Cause Mortality","time_frame":"At 30 days"},{"outcome_type":"secondary","measure":"Kaplan-Meier Freedom From All-Cause Mortality","time_frame":"At 6 months"},{"outcome_type":"secondary","measure":"Device Embolization and Single Leaflet Device Attachment","time_frame":"Through 12 months","description":"Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets.\r\nSingle leaflet device attachment (SLDA) is defined as the loss of insertion of a single leaflet from the MitraClip device with ongoing insertion of the opposing leaflet. SLDAs are reported on ACCESS-EU adverse event log and MitraClip procedure electronic case report forms, and may also be reported by Abbott Vascular personnel per EU Vigilance requirements."},{"outcome_type":"secondary","measure":"1-Day Post-Procedure Safety Outcomes","time_frame":"On day 1 post procedure","description":"This outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups. Because the Medical Therapy&Mitral Valve Surgery comparator groups were followed&studied primarily from a health economic perspective.Availability of clinical outcomes at follow-up is limited & has not been validated. Clinical outcomes for the comparator groups will not be reported."},{"outcome_type":"secondary","measure":"Need for Mitral Valve Surgery","time_frame":"Through 12 months","description":"This end point is assessed on subjects who underwent mitral valve surgery within 12 months post-MitraClip procedure."},{"outcome_type":"secondary","measure":"NYHA Functional Class","time_frame":"At baseline","description":"New York Heart Association (NYHA) Functional Classification.\r\nClass I: Patients with cardiac disease but without resulting limitations of physical activity.\r\nClass II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest.Ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain.\r\nClass III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.Less than ordinary physical activity causes fatigue, palpitation dyspnea or anginal pain.\r\nClass IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort.Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest.If any physical activity is undertaken,discomfort is increased."},{"outcome_type":"secondary","measure":"NYHA Functional Class","time_frame":"At 12 month","description":"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.\r\nClass I: Patients with cardiac disease but without resulting limitations of physical activity.\r\nClass II: Patients with cardiac disease resulting in slight limitation of physical activity.Patients are comfortable at rest.Ordinary physical activity results in fatigue, palpitation, dyspnea/anginal pain.\r\nClass III: Patients with cardiac disease resulting in marked limitation of physical activity.They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea/anginal pain Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort.Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken,discomfort is increased."},{"outcome_type":"secondary","measure":"The Change in 6 Minute Walk Test Distance From Baseline to 12 Months","time_frame":"Baseline and 12 months","description":"The 6 minute walk distance test will be used to measure the patient's exercise capacity. The change in 6 minute walk test distance is calculated as the difference between the distance walked at 12 months and the distanced walked at baseline."},{"outcome_type":"secondary","measure":"Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life Score From Baseline to 12 Months","time_frame":"12 months","description":"The Minnesota Living with Heart Failure Questionnaire(MLHFQ) is comprised of 21 questions.The response for each question ranges from 0(no affect on the patient's living) to 5(affected the patient's life very much during the past month).The total score for the 21 items can range from 0-105.A lower&higher MLHFQ score indicates less effect of heart failure&the worse impact of heart failure on a patient's QOL,respectively.Although the MLHFQ incorporates relevant aspects of the key dimensions of QOL (physical and emotional),the questionnaire was not designed to measure any particular dimension separately.The total score should be taken as the best measure of how heart failure and treatments impact QOL.\r\nThe total score is the sum of a)the physical dimension,measured using 8 questions (possible subscale score range 0-40) b)the emotional dimension,measured using 5 questions(possible subscale score from 0-25)&c) other factors,measured using 8 questions (possible subscale score from 0-40)."},{"outcome_type":"secondary","measure":"Six Minute Walk Test Distance (6MWT)","time_frame":"Baseline","description":"The 6-minute walk distance test will be used to measure the patient's exercise capacity."},{"outcome_type":"secondary","measure":"Six Minute Walk Test Distance (6MWT)","time_frame":"12 months","description":"The 6-minute walk distance test will be used to measure the patient's exercise capacity."}]}
{"nct_id":"NCT01227837","start_date":"2008-10-31","phase":"N/A","enrollment":70,"brief_title":"Effect of omega3 on Congestive Heart Failure","official_title":"Effect of Omega 3 Supplementation on Brain Natriuretic Peptide (BNP) Serum Levels Functional Capacity and Systolic and Diastolic Function of Heart Failure Patients","primary_completion_date":"2009-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-03-31","last_update":"2010-10-25","description":"In this double blinded study patients with resynchronization pacemaker- AICD were assigned to Omega3 and placebo randomly, results indicated that Omega3 had no more effect than placebo in mortality, BNP level and 6 minutes walk test.","other_id":"1388-2365","allocation":"Randomized","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":0.25,"maximum_age":73,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  EF< 40%\r\n\r\n          -  sinus rhythm\r\n\r\n          -  accept randomization\r\n\r\n               -  having tri-chamber pacemaker\r\n\r\n        Exclusion criteria:\r\n\r\n          -  survival less than 6 months\r\n\r\n          -  class IV heart failure\r\n\r\n          -  using drugs other than study protocol\r\n      ","sponsor":"Shiraz University of Medical Sciences","sponsor_type":"Other","conditions":"Heart Failure Congestive","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: omga3","description":"use of omega 3"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: placebo","description":"placebo given to patients"}],"outcomes":[{"outcome_type":"primary","measure":"BNP level","time_frame":"6 months","description":"level of BNP in serum of patient prior and 6 months post recruitment"},{"outcome_type":"primary","measure":"six minutes walk test","time_frame":"6 months","description":"ability to walk in six minutes after and before to syudy"},{"outcome_type":"primary","measure":"echocardiographic data","time_frame":"6 months","description":"Ejection fraction Tei index Sm,Em, Am indexes of tissue doppler study"},{"outcome_type":"secondary","measure":"mortality","time_frame":"6 months","description":"any cardiac mortality in 6 months"},{"outcome_type":"secondary","measure":"hospital admission","time_frame":"6 months","description":"any hospital admission due to cardiac problem in 6 months"}]}
{"nct_id":"NCT00824772","start_date":"2008-09-30","enrollment":204,"brief_title":"Evaluation of Pharmacogenetic Factors Affecting Fentanyl Requirements for Postoperative Pain Control","official_title":"Evaluation of Pharmacogenetic Factors Contributing to Dose Requirement of Fentanyl for Postoperative Pain Control: Genetic Polymorphisms of OPRM1, ABCB1, CYP3A4 and CYP3A5","primary_completion_date":"2010-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2012-12-31","last_update":"2013-06-04","description":"Fentanyl is a widely used opioid analgesic. There are big interindividual variabilities in dose requirements of fentanyl for postoperative pain control. This study aims to reveal the genetic factors affecting the variable requirements of fentanyl during postoperative period.","other_id":"00012007317-00","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"Female","minimum_age":19,"maximum_age":65,"population":"Gynecologic patients undergoing total abdominal hysterectomy or laparoscpy assisted vaginal\r\n        hysterectomy under general anesthesia","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients undergoing total abdominal hysterectomy (TAH) or laparoscopy assisted vaginal\r\n             hysterectomy (LAVH) under general anesthesia\r\n\r\n          -  Patients who want to use intravenous patient controlled analgesia (PCA) after surgery\r\n\r\n          -  ASA physical status class I, II\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  history of drug addiction\r\n\r\n          -  opioid medication within 12 hours before surgery\r\n\r\n          -  previous history of opioid medication for 3 months\r\n\r\n          -  neurologic disorder\r\n\r\n          -  cardiac disorder\r\n\r\n          -  hepatic disease\r\n\r\n          -  renal disease\r\n\r\n          -  respiratory disease such as COPD, asthma\r\n\r\n          -  sleep apnea\r\n\r\n          -  BMI > 30\r\n\r\n          -  psycotic disorder\r\n      ","sponsor":"Inje University","sponsor_type":"Other","conditions":"Pain, Postoperative","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Postoperative Cumulative Fentanyl Consumption","time_frame":"24 hr after surgery"},{"outcome_type":"secondary","measure":"Postoperative Cumulative Fentanyl Consumption","time_frame":"48hr after surgery"}]}
{"nct_id":"NCT00768937","start_date":"2008-09-30","phase":"Phase 1/Phase 2","enrollment":22,"brief_title":"Sorafenib and Transarterial Chemoembolization for Hepatocellular Carcinoma","official_title":"Sorafenib as Inhibitor of Collateral Tumor Vessel Growth During Transarterial Chemoembolisation (TACE) for Hepatocellular Carcinoma (HCC)- a Pilot Trial to Evaluate Safety and Biological Response","primary_completion_date":"2010-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-11-30","last_update":"2010-11-09","description":"Hepatocellular carcinoma (HCC) as the third most common cause of cancer-related death has a very poor prognosis. Aim of this open label single arm non randomized pilot trial is the evaluation of the efficacy and safety of sorafenib in combination with TACE in patients with unresectable HCC. Efficacy ad safety will be compared with a historical TACE-only group of a placebo controlled TACE-trial.","other_id":"SORATACE1","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with histologically confirmed HCC not suitable for OLT or resection ( > 3\r\n             nodules, >5 cm diameter, vascular invasion, clinically significant portal\r\n             hypertension, other contraindications against OLT)\r\n\r\n          -  Child-Pugh Stage A or B\r\n\r\n          -  Liver disease of any etiology\r\n\r\n          -  Written informed consent (approved by the Institutional Review Board [IRB]/Independent\r\n             Ethics Committee [IEC]) obtained prior to any study specific screening procedures\r\n\r\n          -  Patient must be able to comply with the protocol\r\n\r\n          -  Age  18 years\r\n\r\n          -  Women of childbearing potential must have a negative serum pregnancy test done 1 week\r\n             prior to the administration of the Sorafenib.\r\n\r\n        Fertile women and men of childbearing potential ( < 2 years after last menstruation in\r\n        women) must use effective means of contraception (oral contraceptives, intrauterine\r\n        contraceptive device, barrier method of contraception in conjunction with spermicidal jelly\r\n        or surgically sterile)\r\n\r\n          -  Haematology:\r\n\r\n        Absolute neutrophil count (ANC) > 1 x 109/L Platelet count > 40 x 109/L Haemoglobin > 9\r\n        g/dL (may be transfused to maintain or exceed this level) Prothrombin time  40%\r\n\r\n          -  Biochemistry:\r\n\r\n        Total bilirubin < 5 mg/dL Serum creatinine < 3.0 mg/dL\r\n\r\n          -  Life expectancy of > 3 months\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Extrahepatic tumor spread\r\n\r\n          -  Complete portal vein thrombosis (common trunk)\r\n\r\n          -  Child-Pugh-Stage C\r\n\r\n          -  Prior TACE or TAE\r\n\r\n          -  Other experimental therapies for HCC\r\n\r\n          -  Acute variceal bleeding within the last 2 weeks\r\n\r\n          -  Large oesophageal varices ( > 5 mm diameter) without prophylactic band ligation\r\n\r\n          -  Past or current history (within the last 2 years prior to randomisation) of\r\n             malignancies except for the indication under this study and curatively treated basal\r\n             and squamous cell carcinoma of the skin or in situ carcinoma of the cervix\r\n\r\n          -  History or evidence upon physical examination of CNS disease unless adequately treated\r\n             (e.g., seizure not controlled with standard medical therapy or history of stroke\r\n             within < 6 months), excluding hepatic encephalopathy\r\n\r\n          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days\r\n             prior to study treatment start, or anticipation of the need for major surgical\r\n             procedure during the course of the study\r\n\r\n          -  Current or recent (within 10 days prior to study treatment start) use of full-dose\r\n             oral or parenteral anticoagulants for therapeutic purposes\r\n\r\n          -  Chronic, daily treatment with aspirin (>325mg/day)\r\n\r\n          -  Pregnancy (positive serum pregnancy test) or lactation\r\n\r\n          -  Uncontrolled hypertension\r\n\r\n          -  Serious, non-healing wound, ulcer, or bone fracture\r\n\r\n          -  Currently or recent (within the 30 days prior to starting study treatment) treatment\r\n             of another investigational drug or participation in another investigational study\r\n\r\n          -  Clinically significant (i.e. active) cardiovascular disease for example\r\n             cerebrovascular accidents (  6 months prior to study entry), myocardial infarction (\r\n              6 months prior to study entry), unstable angina, New York Heart Association (NYHA)\r\n             grade II or greater congestive heart failure, serious cardiac arrhythmia requiring\r\n             medication\r\n\r\n          -  Evidence of other disease, metabolic dysfunction, physical examination finding, or\r\n             clinical laboratory finding giving reasonable suspicion of a disease or condition that\r\n             contraindicates use of Sorafenib/TACE or patient at high risk from treatment\r\n             complications\r\n      ","sponsor":"Medical University of Vienna","sponsor_type":"Other","conditions":"Hepatocellular Carcinoma","interventions":[{"intervention_type":"Drug","name":"Drug: Sorafenib","description":"All patients will receive Sorafenib (800 mg/day) p.o. beginning two weeks before the first TACE and every day thereafter until patient death or premature withdrawal from study."},{"intervention_type":"Procedure","name":"Procedure: Transarterial chemoembolisation (TACE)","description":"TACE will be carried out with doxorubicin (75 - 50 - 25 mg/m2, depending on serum bilirubin levels  1.5, 1.5 - 3, 3 - 5 mg/dL) : lipiodol (1:1) in a total volume of 20 mL; after administration of doxorubicin:lipiodol, additional embolisation will be carried out with bead block-endospheres. TACE will be repeated every 4 weeks for 3 cycles; additional cycles will be offered if clinically indicated (but no PEI or RF-ablation should be carried out after inclusion into the study)"}],"outcomes":[{"outcome_type":"primary","measure":"Time to Progression (Efficacy)","time_frame":"Until disease progression"},{"outcome_type":"primary","measure":"Safety of Sorafenib in combination with TACE","time_frame":"Continuously until 12 weeks after the last TACE"}]}
{"nct_id":"NCT01368289","start_date":"2008-09-30","enrollment":2000,"brief_title":"Australian Multicentre Colonic Endoscopic Mucosal Resection Study","official_title":"Australian Multicentre Colonic Endoscopic Mucosal Resection (ACE/EMR) Study","primary_completion_date":"2021-09-30","study_type":"Observational","rec_status":"Recruiting","completion_date":"2022-09-30","last_update":"2021-03-23","description":"A prospective, multicentre, observational study of all patients referred for endoscopic resection of sessile colorectal polyps sized 20 mm conducted with intention to treat analysis.","other_id":"ACE/EMR","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"Any patient who presents to the Unit with the intention to treat large sessile colonic\r\n        polyps equal to or greater than 20mm.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Large sessile polyp (equal to or greater than 20mm)\r\n\r\n          -  Intention to perform EMR\r\n\r\n          -  Aged 18 years or older\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Colonic polyps less than 20mm\r\n\r\n          -  Aged younger then 18 years.\r\n      ","sponsor":"Professor Michael Bourke","sponsor_type":"Other","conditions":"Colonic Polyps","interventions":[{"intervention_type":"Procedure","name":"Procedure: Endoscopic Mucosal Resection","description":"Endoscopic Mucosal Resection of large sessile colonic polyps."}],"outcomes":[{"outcome_type":"primary","measure":"Technical success for Endoscopic resection","time_frame":"6-60 months","description":"To determine the safety, efficacy and predictors of success for Endoscopic Mucosal Resection of large sessile colorectal polyps. The utility of endoscopic criteria to stratify for the risk of Submucosal Invasive Cancer was also assessed."}]}
{"nct_id":"NCT00747669","start_date":"2008-09-30","phase":"Phase 4","enrollment":11,"brief_title":"Pharmacokinetic Study of Synera in Neonates and Infants","official_title":"A Pharmacokinetic Study of Synera (Lidocaine 70 mg and Tetracaine 70 mg Topical Patch) to Evaluate the Systemic Exposure to Lidocaine and Tetracaine in Neonates and Infants","primary_completion_date":"2013-04-30","study_type":"Interventional","rec_status":"Suspended","completion_date":"2013-04-30","last_update":"2012-03-23","description":"This study will measure the amount of lidocaine and tetracaine in the blood after a 30 minute application of Synera.","other_id":"EN3274-401","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","maximum_age":0.33333,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subject must be an infant of 1 to 4 months of age and weigh at least 2.5 kg or a\r\n             neonate of 0 to 4 weeks postnatal age with a gestation period of at least 37 weeks,\r\n             and weigh at least 1.8 kg.\r\n\r\n          -  Subject is scheduled to have a medically indicated minor superficial procedure for\r\n             which topical local anesthesia would provide a benefit.\r\n\r\n          -  Subject has or will have an indwelling vascular access catheter for blood sampling at\r\n             the time of the procedure visit. The indwelling vascular access catheter placement\r\n             must be necessary for medical reasons other than the purposes of this study.\r\n\r\n          -  The additional blood draws for the purposes of this study do not pose more than a\r\n             minor risk to the health and welfare of the subject.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subject has known allergies or sensitivities to any component of Synera.\r\n\r\n          -  Subject has clinically significant laboratory abnormalities.\r\n\r\n          -  Subject has known multiple allergies that could indicate hypersensitive skin.\r\n\r\n          -  Subject has known active atopic dermatitis at or near the patch application site.\r\n      ","sponsor":"ZARS Pharma Inc.","sponsor_type":"Industry","conditions":"Pain","interventions":[{"intervention_type":"Drug","name":"Drug: lidocaine 70mg and tetracaine 70mg topical patch","description":"One Synera Patch applied for 30 minutes."}],"outcomes":[{"outcome_type":"primary","measure":"Evaluate the systemic exposure to lidocaine and tetracaine following application of Synera","time_frame":"30 hours"},{"outcome_type":"secondary","measure":"Monitor the nature and frequency of adverse events","time_frame":"30 Hours"}]}
{"nct_id":"NCT00802399","start_date":"2008-09-30","phase":"N/A","enrollment":37,"brief_title":"Partial Lacrimal Punctual Occlusion","official_title":"Partial Lacrimal Punctual Occlusion in the Management of Dry Eye","primary_completion_date":"2008-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-11-30","last_update":"2009-01-22","description":"The purpose of this study is to describe a case series of patients with chronic dry eye submitted to partial punctual occlusion.","other_id":"0300/08","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":40,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Sin and symptom of dry eye\r\n\r\n          -  Use more than 4 times a day topic lubricant for the eye\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Ocular diseases other than dry eye\r\n\r\n          -  Use of systemic drugs\r\n      ","sponsor":"University of Sao Paulo General Hospital","sponsor_type":"Other","conditions":"Dry Eye","interventions":[{"intervention_type":"Procedure","name":"Procedure: Partial Lacrimal Punctual Occlusion","description":"Cauterization of the edge of all lacrimal punctum was carried out in all patients"}],"outcomes":{}}
{"nct_id":"NCT00610155","start_date":"2008-09-30","phase":"N/A","enrollment":18,"brief_title":"A Methodology Study Of Brain Imaging Of Pain-Killers In Post-Traumatic Neuropathic Pain Patients","official_title":"A Methodology Study To Assess The Feasibility Of Using Functional Magnetic Resonance Imaging (fRMI) To Quantify The Effects Of Analgesic Drugs In Post-Traumatic Neuropathic Pain Subjects","primary_completion_date":"2010-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-07-31","last_update":"2021-01-22","description":"This study is a methodology study designed to discover whether a brain imaging technology is a better way of compare the relative sensitivities of fMRI and subjective psychometric assessments of pain to multiple doses of pregabalin and tramadol SR in a cross-over clinical study design.","other_id":"A0081173","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosis of neuropathic pain associated with brush allodynia in specific dermatomes.\r\n\r\n          -  Brush allodynia score of 4 and calculated average pain score of 3 on an 11-point\r\n             numerical rating scale by the completion of down-titration of existing medications.\r\n\r\n          -  Right-handed\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subjects with trigeminal neuralgia, central pain (due to cerebrovascular lesions,\r\n             multiple sclerosis and/or traumatic spinal cord injuries including spinal surgery).\r\n\r\n          -  Phantom limb pain, painful diabetic neuropathy.\r\n\r\n          -  Subjects with any other co-existing pain which he/she or a qualified pain physician\r\n             cannot differentiate from NeP of peripheral origin.\r\n\r\n          -  Subjects with diabetes mellitus and with an HbA1C value of >10% upon measurement at\r\n             screening.\r\n      ","sponsor":"Pfizer's Upjohn has merged with Mylan to form Viatris Inc.","sponsor_type":"Industry","conditions":"Pain","interventions":[{"intervention_type":"Drug","name":"Drug: Placebo","description":"BID"},{"intervention_type":"Drug","name":"Drug: Pregabalin","description":"Dose 75 mg titrated to 150 mg, bid"},{"intervention_type":"Drug","name":"Drug: Tramadol SR","description":"Dose 50mg titrated to 200 mg, bid"}],"outcomes":[{"outcome_type":"primary","measure":"Voxel-wise Blood Oxygen Level Dependent (BOLD) Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals Across the Whole Brain","time_frame":"Day 8, 22, 36","description":"BOLD brain activation signals in whole brain was assessed using Contrast Parameter Estimates (COPE) images in response to dynamic mechanical allodynia of the affected side (DMAa), dynamic mechanical allodynia of the control side (DMAc), thermal pain (TH) and checkerboard visual stimuli (VIS)."},{"outcome_type":"primary","measure":"Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Affected Side (DMAa)","time_frame":"Day 8, 22, 36","description":"BOLD brain activation signals in pre-defined region of interest(ROI):anterior cingulate cortex(ACC);left,right anterior cortex([AIC_L ],[AIC_R]);left,right mid-insular cortex([MIC_L],[MIC_R]);left,right posterior insular cortex([PIC_L],[PIC_R]);left,right amygdala([Amyg_L],[Amyg_R]);primary,secondary somatosensory cortex([S1],[S2]);sensory part of thalamus(SensTHAL);midbrain reticular formation(MRF);nucleus cuneiformis(NucCun);periaqueductal gray(PAG). Prior to ROI analysis, a prelimanary anlysis was performed, wherein it was concluded that ROI analysis was to be carried out for DMAa, DMAc amd TH only. In voxel BOLD analysis,signal change is unit less measure but approximated to percent signal change by grand scaling(effects divided by 10000 to get percent signal change)."},{"outcome_type":"primary","measure":"Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Control Side (DMAc)","time_frame":"Day 8, 22, 36","description":"BOLD brain activation signals in pre-defined ROI. ROI were ACC; AIC_L; AIC_R; MIC_L; MIC_R; PIC_L; PIC_R; Amyg_L; Amyg_R; S1; S2; SensTHAL; MRF; NucCun; PAG. Prior to ROI analysis, a prelimanary anlysis was performed, wherein it was concluded that ROI analysis was to be carried out for DMAa, DMAc amd TH only. In voxel BOLD analysis, signal change is unit less measure but is approximated to percent signal change here by grand scaling (dividing effects by 10000 to get percent signal change)."},{"outcome_type":"primary","measure":"Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Thermal Stimulation (TH)","time_frame":"Day 8, 22, 36","description":"BOLD brain activation signals in pre-defined ROI. ROI were ACC; AIC_L; AIC_R; MIC_L; MIC_R; PIC_L; PIC_R; Amyg_L; Amyg_R; S1; S2; SensTHAL; MRF; NucCun; PAG. Prior to ROI analysis, a prelimanary anlysis was performed, wherein it was concluded that ROI analysis was to be carried out for DMAa, DMAc amd TH only. In voxel BOLD analysis, signal change is unit less measure but is approximated to percent signal change here by grand scaling (dividing effects by 10000 to get percent signal change)."},{"outcome_type":"primary","measure":"Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Visual Stimulation (VIS)","time_frame":"Day 8, 22, 36","description":"BOLD brain activation signals in pre-defined ROI in response to checkerboard visual stimuli (flashing at 2 Hz). ROI were ACC; AIC_L; AIC_R; MIC_L; MIC_R; PIC_L; PIC_R; Amyg_L; Amyg_R; S1; S2; SensTHAL; MRF; NucCun; PAG. Prior to ROI analysis, a prelimanary anlysis was performed, wherein it was concluded that ROI analysis was to be carried out for DMAa, DMAc amd TH only."},{"outcome_type":"primary","measure":"Arterial Spin Labelling (ASL) Using fMRI of Brain Activation Signals Across the Whole Brain and in Defined Brain Regions","time_frame":"Day 8, 22, 36","description":"Continuous ASL sequence fMRI imaging modality assessing brain activation signals across the whole brain and in defined ROI to assess effects of evoked pain along with changes in regional cerebral blood flow (rCBF). ROI were ACC; AIC_L; AIC_R; MIC_L; MIC_R; PIC_L; PIC_R; Amyg_L; Amyg_R; S1; S2; SensTHAL; MRF; NucCun; PAG."},{"outcome_type":"secondary","measure":"36-Item Short-Form Health Survey (SF-36)","time_frame":"Day 8, 22, 36","description":"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning)."},{"outcome_type":"secondary","measure":"Beck Depression Inventory (BDI)","time_frame":"Day 8, 22, 36","description":"BDI is a 21 item participant rated inventory evaluating depression symptoms, cognition, and physical symptoms of fatigue, weight loss, lack of interest in sex. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe. Total score: 0 to 63; higher score indicate more depression."},{"outcome_type":"secondary","measure":"State and Trait Anxiety Questionnaire","time_frame":"Day 8, 22, 36","description":"Self-report scale completed by the participant. Separate scales measure state (20 items) and trait (20 items) anxiety. The participant report how they feel \"right now at this moment\" for state anxiety and how they \"generally\" feel for trait anxiety. The \"state\" items are scored as: 1 (not at all), 2 (somewhat true), 3 (moderately true), 4 (very much so). The \"trait\" items are scored as: 1 (almost never), 2 (sometimes), 3 (often), 4 (almost always). Scores range from 20-80 for each scale. Higher scores indicate more impaired participants."},{"outcome_type":"secondary","measure":"Pain Catastrophising Scale (PCS)","time_frame":"Day 8, 22, 36","description":"The PCS is a self-administered questionnaire with 13 items, each scored from 0 (not at all) to 4 (all the time) for extent to which participant catastrophizes postoperative pain. Total score is sum of scores for all questions (range: 0 to 52); Subscale scores: Rumination (sum of scores for 4 items; range: 0 to 16); Magnification (sum of scores for 3 items; range: 0 to 12); and Helplessness (sum of scores for 6 items; range: 0 to 24); higher scores indicate greater extent of pain catastrophizing."},{"outcome_type":"secondary","measure":"Neuropathic Pain Symptom Inventory (NPSI)","time_frame":"Baseline (Day -7), Day 8, 22, 36","description":"NPSI: participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicate a greater intensity of pain."},{"outcome_type":"secondary","measure":"Daily Pain Score","time_frame":"Day -35 through Day 36","description":"Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning using 0-10 numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain). The daily pain scores for an average of the last 7 days and an average of last 3 days were calculated."},{"outcome_type":"secondary","measure":"Present Pain Intensity Score (PPIS)","time_frame":"Day 8, 22, 36","description":"Participants answered: \"Please rate your pain from 0-10 that best describes the intensity of pain right now\". PPIS assessed on 0-10 numeric rating scale (NRS), 0 (no pain) to 10 (worst possible pain)."},{"outcome_type":"secondary","measure":"Doleur Neuropathic 4 (DN4) Score","time_frame":"Day -35","description":"DN4 questionnaire provides a simple diagnosis of Neuropathic pain (NeP) by asking for yes/no answers to 4 questions (10 sub questions in total). Each question was scored on a scale of 0 (No) and 1 (Yes). Total score was calculated as sum of the 10 individual questions. Total score range 0-10, higher score indicated more neuropathic pain."}]}
{"nct_id":"NCT00758615","start_date":"2008-09-30","phase":"N/A","enrollment":149,"brief_title":"Pilot Evaluation of a Walking School Bus Program","official_title":"Pilot and Feasibility Evaluation of a Walking School Bus Program Intervention for Elementary School Students","primary_completion_date":"2009-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-06-30","last_update":"2013-12-06","description":"Walking to school is one of the objectives for children and adolescents in Healthy People 2010 and in previous studies was associated with higher levels of overall physical activity, which has been shown to decrease obesity. Therefore, more children walking to school should result in increased physical activity and presumably reduce obesity. However, increasing child pedestrian activity could increase the risk of child pedestrian injuries. Walking with an adult who provides instruction in pedestrian skills and monitors the child's actual behavior may be the most important component of a successful intervention. Walking with an adult reduced child pedestrian injury risk by almost 70%. A walking school bus (WSB) addresses safety concerns by providing a period of physical activity supervised by several responsible adults and teaching opportunities around pedestrian safety skills on the way to and from school. Children may join the WSB at various points along the set route. Despite the growing popularity of WSB programs in the United States, randomized, controlled-studies are lacking that examine the impact on children's safety, physical activity, and health. We seek to help fill this gap in the literature by piloting a WSB program in elementary schools in the Houston Independent School District to test feasibility. We hypothesize that a WSB program will: (1) increase the number of students walking to school and decrease the number of students driven to school by car, (2) increase students' pedestrian safety behaviors (3) increase students' physical activity, and (4) decrease students' excess weight gain.","other_id":"1R21CA133418-01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":8,"maximum_age":12,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  4th grade student at a study school in the Houston Independent School District\r\n\r\n          -  Must be physically able to walk to and from school\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any condition that would prevent the student from walking to or from school\r\n      ","sponsor":"Seattle Children's Hospital","sponsor_type":"Other","conditions":"Obesity|Physical Activity|Pedestrian Safety|Injury Prevention","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Walking School Bus","description":"Students are chaperoned to and from school by adults (study staff or parent volunteers) along set routes."}],"outcomes":[{"outcome_type":"primary","measure":"Method of student transportation to school","time_frame":"Immediately pre- and post-intervention"},{"outcome_type":"secondary","measure":"Physical activity","time_frame":"Immediately pre- and post-intervention","description":"Physical activity objectively measured by accelerometers."},{"outcome_type":"secondary","measure":"Pedestrian crosswalk behavior","time_frame":"Immediately pre- and post-intervention"},{"outcome_type":"secondary","measure":"Parents' psychosocial constructs related to allowing their child to walk to school","time_frame":"Immediately pre- and post-intervention"},{"outcome_type":"secondary","measure":"Child's self-efficacy for walking to school","time_frame":"Immediately pre- and post-intervention"}]}
{"nct_id":"NCT00813397","start_date":"2008-09-30","phase":"N/A","enrollment":210,"brief_title":"Manageability and Safety Assessment of Sepraspray in Abdominal Surgery.","official_title":"Manageability and Safety Assessment of the SepraSpray Anti-adhesion Barrier in Abdominal Coelioscopic Surgery","primary_completion_date":"2009-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-07-31","last_update":"2015-05-22","description":"This study will examine the performance of SeprasSpray in patients undergoing abdominal surgery (laparoscopic).","other_id":"SSPRAY00608","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients 18 years old and over that require laparoscopic abdominal surgery\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who are pregnant or have an ongoing infectious complications from a previous\r\n             surgery\r\n      ","sponsor":"Genzyme, a Sanofi Company","sponsor_type":"Industry","conditions":"Adhesion Prevention","interventions":[{"intervention_type":"Device","name":"Device: Sepraspray","description":"Max. 10g of Sepraspray"}],"outcomes":[{"outcome_type":"primary","measure":"Morbidity","time_frame":"30 days"}]}
{"nct_id":"NCT01278888","start_date":"2008-09-30","phase":"N/A","enrollment":294,"brief_title":"Minimally Invasive or Open Surgery for Lung Cancer: Pain, Quality of Life and Economics.","official_title":"Minimally Invasive or Open Surgery for Lung Cancer: Pain, Quality of Life and Economics.","primary_completion_date":"2017-09-18","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-09-18","last_update":"2020-10-23","description":"Is thoracoscopic surgery better than traditional open surgery for lung cancer? Video assisted thoracoscopic surgery for lung cancer (VATS) is presumed to be less traumatic than traditional open surgery for lung cancer but this has never been documented in a randomized trial. Some surgeons hesitate to use VATS because it is technically more demanding, others question if the two methods are oncologically equal. Regardless, VATS has been implemented as a routine method for lung cancer surgery several places around the world including Odense University Hospital. The investigators have launched the first randomized controlled trial in the world comparing the two surgical methods to investigate any differences in length of hospitalization, postoperative pain, life quality within the first year, and health economics. The investigators include patients with stage I and II lung cancer, and randomize between VATS and open surgery in a design where both the patient and doctors doing general rounds in the ward are blinded until discharge because the dressing on the surgical wound is identical, regardless of the surgical method. The surgeon cannot influence clinical decisions including time to discharge, which is decided by other specialist surgeons. Pain evaluation is performed 6 times daily using the VAS-score, life quality is evaluated continuously during the first 12 months using EQ5D and EORTC QLQC-30 questionnaires, and the consumption of analgetics in both groups are monitored via the national prescription database. Parallel to this trial a similar clinical study, which is also the first of its kind in the world, has been launched for patients with lung cancers not eligible for VATS. They are randomized between the two traditional open surgical methods (anterolateral and posterolateral thoracotomy) - this is also blinded to both patient and doctors doing rounds until discharge from hospital, and endpoint are similar in the two studies. 206 patients have been randomized in the first substudy (VATS vs. open) and 88 in the second substudy (posterolateral vs. anterolateral).","other_id":"s-20080085","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Eligible for surgery for lunge cancer.\r\n\r\n          -  Elective surgery (surgery planed > 2 days)\r\n\r\n          -  Accepts randomization\r\n\r\n          -  Age 18 or above.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Previous thoracic surgery\r\n\r\n          -  Planned segment resection or pneumonectomy.\r\n\r\n          -  Any type of chronic pain, requiring daily use of analgetics\r\n\r\n          -  pregnant\r\n\r\n          -  Breast feeding\r\n\r\n          -  T3, T4 tumors or cerebral tumors.\r\n\r\n          -  contraindications to NSAID\r\n\r\n          -  Chemo- and/or radiotherapy in connection to present admission.\r\n\r\n          -  Major surgery planned in connection to this admission.\r\n      ","sponsor":"Peter B Licht","sponsor_type":"Other","conditions":"Nonsmall Cell Lung Cancer Cellular Diagnosis","interventions":[{"intervention_type":"Procedure","name":"Procedure: Anterolateral thoracotomy","description":"Standard anterolateral thoracotomy"},{"intervention_type":"Procedure","name":"Procedure: Posterolateral thoracotomy","description":"Standard muscle sparing posterolateral thoracotomy"},{"intervention_type":"Procedure","name":"Procedure: VATS","description":"Standard video assisted thoracic surgery, no use of rib-spreader."},{"intervention_type":"Procedure","name":"Procedure: Anterolateral Thoracotomy","description":"Standard anterolateral thoracotomy"}],"outcomes":[{"outcome_type":"primary","measure":"Postoperative pain","time_frame":"12 months","description":"Aim is to asses the development of acute and chronic pain after lobectomy."},{"outcome_type":"secondary","measure":"Quality of life","time_frame":"12 months","description":"Three questionnaires are used. EQ5D, QLQC-30 and WPAI."},{"outcome_type":"secondary","measure":"Economy","time_frame":"12 months","description":"An economical evaluation will be done. Including in-hospital expences, use of sociale-security, readmissions to hospital, use of family practioner, use of and duration of prescription analgetics, wether or not patients are able to return to work, the effect this type of surgery has on the patients quality of life, including a QALY evaluation and cost utility analysis."}]}
{"nct_id":"NCT01197456","start_date":"2008-09-24","enrollment":232,"brief_title":"Predictors of Ovarian Insufficiency in Young Breast Cancer Patients","official_title":"Predictors of Ovarian Insufficiency Through Serial Exams in Young Breast Cancer Patients (POISE Study)","primary_completion_date":"2016-06-30","study_type":"Observational","rec_status":"Completed","completion_date":"2019-07-18","last_update":"2020-04-22","description":"More than two million American women are breast cancer survivors. Approximately one-third of these women are premenopausal at diagnosis and face issues related to reproduction as they undergo cancer treatment. Ovarian function after breast cancer diagnosis has implications on breast cancer prognosis, choice of adjuvant therapy and reproductive issues such as desire for fertility or concerns about menopause. Therefore, tools to accurately predict ovarian function in breast cancer survivors could significantly impact physicians and patients in counseling, medical and surgical treatment choices, and consideration of fertility preservation options. The goal of this proposal is to identify pre-chemotherapy hormonal, genetic and ovarian imaging markers that can predict ovarian failure and characterize the course of ovarian function after chemotherapy. The investigators plan to follow a group of young women from breast cancer diagnosis to five years after chemotherapy. The investigators will study the following risk factors: blood hormone levels that reflect ovarian function, genetic mutations that affect how individuals metabolize chemotherapy, and ovarian size and egg count by MRI and ultrasound. The investigators hypothesize that these biomarkers are related to risk of ovarian insufficiency singly. After examining these individual risk factors for ovarian failure, the investigators will put them together into an Ovarian Failure Clinical Predictive Index. This index will be a tool similar to the Gail Model that can be used to determine individual risk for ovarian failure. This tool would assist young breast cancer patients and their physicians in making treatment decisions that would impact cancer survival and reproduction.","other_id":"UCSD POISE","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"Female","minimum_age":18,"maximum_age":45,"population":"Newly diagnosed breast cancer patients","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  New diagnosis of breast cancer (Stages 0-III)\r\n\r\n          -  Age <=45\r\n\r\n          -  Premenopausal (at least one menses over past year)\r\n\r\n          -  Has a uterus and at least one ovary\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior chemotherapy\r\n      ","sponsor":"University of California, San Diego","sponsor_type":"Other","conditions":"Breast Cancer|Ovarian Insufficiency|Ovarian Failure","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Number of Participant Ovarian Insufficiency (Without of Menses for 12 Months) After Breast Cancer Diagnosis","time_frame":"Years 1-5","description":"Number of participant without of menses for 12 months after breast cancer diagnosis"},{"outcome_type":"secondary","measure":"Number of Participants Who Experience Return of Menses After 3 Months of Amenorrhea","time_frame":"Years 1-5","description":"Number of participants who experience return of menses after 3 months of amenorrhea"}]}
{"nct_id":"NCT00961935","start_date":"2008-08-31","enrollment":50,"brief_title":"Pediatric Bipolar Disorder Study at UCLA","official_title":"Examining Neurocognitive Profiles of Bipolar Disorder and Attention-Deficit Hyperactivity Disorder","primary_completion_date":"2011-08-31","study_type":"Observational","rec_status":"Completed","completion_date":"2011-09-30","last_update":"2016-01-13","description":"The UCLA Semel Institute for Neuroscience in Los Angeles, CA, is conducting a study looking at similarities and differences in how the brain works between bipolar disorder and attention deficit hyperactivity disorder (ADHD).","other_id":"P50MH077248-02","time_perspective":"Cross-Sectional","sampling_method":"Probability Sample","gender":"All","minimum_age":7,"maximum_age":17,"population":"Bipolar Disorder","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subject suffers clinically impairing symptoms of mood lability.\r\n\r\n          -  Child has resided with primary caretaker for at least 6 months.\r\n\r\n          -  Caretaker speaks sufficient English to complete all study evaluations and measures.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Lifetime history of mental retardation, autism, or primary diagnosis of psychosis.\r\n\r\n          -  Subject is pregnant or nursing.\r\n      ","sponsor":"University of California, Los Angeles","sponsor_type":"Other","conditions":"Bipolar Disorder","interventions":{},"outcomes":{}}
{"nct_id":"NCT01213615","start_date":"2008-08-31","enrollment":179,"brief_title":"Hancock II Ultra Porcine Bioprosthesis Hemodynamic Study","primary_completion_date":"2013-10-31","study_type":"Observational","rec_status":"Completed","completion_date":"2014-05-31","last_update":"2015-10-30","description":"Since the first implant in September 1982, the Medtronic Hancock II has provided more than 20 years of excellent hemodynamic performance and durability. Design improvements over the past generations include: low profile, flexible stent, Supra-X supra-annular placement, T6 anti-calcification tissue treatment, modified fixation process, CINCH advanced implant system and ULTRA minimized sewing ring. Valve sizing is a critical consideration in obtaining optimal hemodynamic performance. This is particular true in small aortic roots. A critical issue is the size of the prosthesis in relation to the patient's annulus. The objective of this clinical study is to evaluate, at six and twelve months, the hemodynamic performance of the Hancock Ultra bioprosthesis in the aortic position, to analyze the incidence of patient prosthesis mismatch, correlation of gradients, and to ascertain frequency at which a larger valve size is used vs. a patient's debrided annulus diameter.","other_id":"Rev B February 4, 2010","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"The patient population includes all patients who require aortic valve replacement for heart\r\n        valve disease (acquired or congenital) and who are candidates for a bioprosthetic valve.\r\n        Patients will be informed about the aspects of this study and will be asked to give their\r\n        Informed Consent.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients who require aortic valve replacement with or without coronary artery bypass\r\n             grafting or surgical treatment of atrial fibrillation or mitral valve repair.\r\n\r\n          -  Patients who are able to provide informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Concomitant procedures other than coronary artery bypass grafting, surgical treatment\r\n             of atrial fibrillation or mitral valve repair.\r\n\r\n          -  Patients indicated for receiving a mechanical prosthesis.\r\n\r\n          -  Patients who will have a replacement of existing valve prosthesis.\r\n\r\n          -  Patients refusing or not able to provide informed consent.\r\n\r\n          -  Patients requiring emergency surgery.\r\n\r\n          -  Patients unable to participate in follow-up\r\n      ","sponsor":"Medtronic Bakken Research Center","sponsor_type":"Industry","conditions":"Aortic Heart Valve Diseases","interventions":[{"intervention_type":"Device","name":"Device: Valve replacement","description":"Aortic valve replacement of Hancock II Ultra porcine bioprosthesis"}],"outcomes":[{"outcome_type":"primary","measure":"The primary objective of the study is the hemodynamic performance of the bioprosthesis at 6 and 12 months after surgery.","time_frame":"6 and 12 months after surgery","description":"This will be measured by comparing the mean aortic valve gradients pre- and post-surgery.Left ventricular mass regression will be compared pre operative and at 6 months follow-up. The follow-up data at 12 months will be used to see if there was any improvement with the 6 months follow-up visit. ."},{"outcome_type":"secondary","measure":"The secondary objective of the study is the incidence of patient prosthesis mismatch (PPM).","time_frame":"5 to 15 days post procedure","description":"This is measured by collecting valve sizing data during implant and the ultimate valve sizes used for implant"}]}
{"nct_id":"NCT00708500","start_date":"2008-08-31","phase":"Phase 3","enrollment":404,"brief_title":"Boceprevir in Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin (Study P05101AM3)(COMPLETED)","official_title":"A Phase 3 Safety and Efficacy Study of Boceprevir in Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin","primary_completion_date":"2010-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-04-30","last_update":"2017-04-07","description":"This study involves treatment with boceprevir or placebo in combination with pegylated interferon alfa-2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) in adult subjects with chronic hepatitis C (CHC) genotype 1 who demonstrated interferon responsiveness (a decrease in hepatitis C virus RNA [HCV-RNA] viral load >=2 log10 by Week 12 or undetectable HCV-RNA at end of treatment) but who failed to achieve sustained virologic response (SVR) on prior treatment with any combination therapy of peginterferon alpha and RBV. This trial includes three arms, one control arm (PEG2b + RBV for 48 weeks) and two experimental arms (PEG2b + RBV + boceprevir). One of the experimental arms, Arm 3, consists of treatment with all three drugs for 44 weeks after the lead-in. The other experimental arm, Arm 2, consists of all three drugs for 32 weeks after the lead-in. Participants in Arm 2 who were undetectable for HCV-RNA at Treatment Week 8 will complete treatment at that point. Those who were not undetectable for HCV-RNA at Treatment Week 8 will receive an additional 12 weeks of PEG2b + RBV + boceprevir placebo. It is hypothesized that the addition of a third active anti-HCV drug may lead to more rapid viral response than therapy with two drugs, and therefore, the addition of boceprevir to PEG2b plus RBV therapy after a 4-week lead-in period may allow for both increased rates of SVR and shorter treatment durations (in some populations) than treatment with peginterferon plus RBV alone.","other_id":"P05101","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Qualifying regimen defined as pegylated interferon alfa-2a plus ribavirin or pegylated\r\n             interferon alfa-2b plus ribavirin for a minimum of 12 weeks.\r\n\r\n          -  During qualifying regimen, participants must have either a documented undetectable\r\n             HCV-RNA within 30 days of end of treatment (EOT) and a subsequent detectable HCV-RNA\r\n             during follow-up or a documented decline in HCV-RNA by >=2 log10 by Treatment Week 12\r\n\r\n          -  Previously documented CHC genotype 1 infection.\r\n\r\n          -  Liver biopsy with histology consistent with CHC and no other etiology.\r\n\r\n          -  Participants with bridging fibrosis or cirrhosis must have an ultrasound within 6\r\n             months of the Screening Visit (or between Screening and Day 1) with no findings\r\n             suspicious for hepatocellular carcinoma (HCC).\r\n\r\n          -  Participants participating in Schering-Plough Research Institute (SPRI) maintenance\r\n             protocols P02570 (NCT00049842) or P02569 (NCT00048724) must have completed the study\r\n             to be eligible for this protocol.\r\n\r\n          -  Participants must be >=18 years of age.\r\n\r\n          -  Participants must weigh between 40 kg and 125 kg.\r\n\r\n          -  Participants and participant's partner(s) must each agree to use acceptable methods of\r\n             contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months\r\n             after last dose of study drug, or longer if dictated by local regulations.\r\n\r\n          -  Participants must be willing to give written informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Coinfection with the human immunodeficiency virus (HIV) or hepatitis B virus\r\n             (Hepatitis B Surface Antigen [HBsAg] positive).\r\n\r\n          -  Discontinuation of previous interferon or ribavirin regimen for an adverse event (AE)\r\n             considered by the investigator to be possibly or probably related to ribavirin and/or\r\n             interferon.\r\n\r\n          -  Treatment with ribavirin within 90 days and any interferon-alpha within 1 month of\r\n             Screening.\r\n\r\n          -  Treatment for hepatitis C with any investigational medication. Prior treatment with\r\n             herbal remedies with known hepatotoxicity.\r\n\r\n          -  Treatment with any investigational drug within 30 days of the randomization visit.\r\n\r\n          -  Participation in any other clinical trial within 30 days of randomization or intention\r\n             to participate in another clinical trial.\r\n\r\n          -  Evidence of decompensated liver disease including, but not limited to, a history or\r\n             presence of clinical ascites, bleeding varices, or hepatic encephalopathy.\r\n\r\n          -  Diabetic and/or hypertensive participants with clinically significant ocular\r\n             examination findings.\r\n\r\n          -  Pre-existing psychiatric conditions.\r\n\r\n          -  Clinical diagnosis of substance abuse of the specified drugs within the specified\r\n             timeframes\r\n\r\n          -  Any known pre-existing medical condition that could interfere with the participant's\r\n             participation in and completion of the study.\r\n\r\n          -  Evidence of active or suspected malignancy, or a history of malignancy, within the\r\n             last 5 years (except adequately treated carcinoma in situ and basal cell carcinoma of\r\n             the skin). Participants under evaluation for malignancy are not eligible.\r\n\r\n          -  Participants who are pregnant or nursing. Participants who intend to become pregnant\r\n             during the study period. Male participants with partners who are, or intend to become,\r\n             pregnant during the study period.\r\n\r\n          -  Any other condition which, in the opinion of a physician, would make the participant\r\n             unsuitable for enrollment or could interfere with the participant participating in and\r\n             completing the study.\r\n\r\n          -  Participants who are part of the site personnel directly involved with this study.\r\n\r\n          -  Participants who are family members of the investigational study staff.\r\n\r\n          -  Participants who had life-threatening serious adverse event (SAE) during screening\r\n             period.\r\n\r\n          -  Protocol-specified hematologic, biochemical, and serologic criteria: Hemoglobin <12\r\n             g/dL for females and <13 g/dL for males; Neutrophils <1500/mm^3 (Blacks: <1200/mm^3);\r\n             Platelets <100,000/mm^3; Direct bilirubin >1.5 x upper limit of normal (ULN).\r\n\r\n          -  Serum albumin <lower limit of normal (LLN)\r\n\r\n          -  Thyroid-stimulating hormone (TSH) >1.2 x ULN or <0.8 x LLN of laboratory reference\r\n             range, with certain exceptions.\r\n\r\n          -  Serum creatinine >ULN of the laboratory reference.\r\n\r\n          -  Protocol-specified serum glucose concentrations.\r\n\r\n          -  Protocol-specified alpha fetoprotein range.\r\n\r\n          -  Prothrombin Time/Partial Thromboplastin Time (PT/PTT) values >10% above laboratory\r\n             reference range.\r\n\r\n          -  Anti-nuclear antibodies (ANA) >1:320.\r\n      ","sponsor":"Merck Sharp & Dohme Corp.","sponsor_type":"Industry","conditions":"Hepatitis C, Chronic","interventions":[{"intervention_type":"Drug","name":"Drug: Boceprevir (SCH 503034)","description":"Boceprevir, 200 mg capsules, 800 mg TID PO"},{"intervention_type":"Biological","name":"Biological: Pegylated interferon alfa-2b (SCH 54031)","description":"PEG2b 1.5 g/kg/week subcutaneously (SC)"},{"intervention_type":"Drug","name":"Drug: Ribavirin (SCH 18908)","description":"Ribavirin WBD 600 mg/day to 1400 mg/day by mouth (PO) divided twice daily (BID)."},{"intervention_type":"Drug","name":"Drug: Boceprevir placebo","description":"Boceprevir placebo, 200 mg capsules, 800 mg three times daily (TID) PO."}],"outcomes":[{"outcome_type":"primary","measure":"Sustained Virologic Response (SVR) Rate in the Full Analysis Set (FAS) Population.","time_frame":"At Follow-up Week 24","description":"SVR is defined as undetectable plasma hepatitis C virus RNA (HCV-RNA) at Follow-up Week 24. This outcome measure evaluates SVR after treatment with boceprevir and PEG2b plus RBV versus PEG2b plus RBV alone in participants with chronic hepatitis C (CHC) genotype 1 who failed prior treatment."},{"outcome_type":"secondary","measure":"Sustained Virologic Response (SVR) Rate in the Modified Intent to Treat (mITT) Population.","time_frame":"At Follow-up Week 24","description":"SVR is defined as undetectable plasma HCV-RNA at Follow-up Week 24. This outcome measure evaluates SVR after treatment with boceprevir and PEG2b plus RBV versus PEG2b plus RBV alone in participants with CHC genotype 1 who failed prior treatment.\r\nThis key secondary efficacy endpoint was added as per the second protocol amendment on 02 DEC 2009."},{"outcome_type":"secondary","measure":"Number of Participants With Early Virologic Response.","time_frame":"At Week 2, 4, 8, or 12","description":"Having undetectable HCV-RNA at Week 2, 4, 8, or 12 was considered Early Virologic Response."},{"outcome_type":"secondary","measure":"Number of Participants With Undetectable HCV-RNA at Follow-up Week 12 and at 72 Weeks After Randomization.","time_frame":"At Follow-up Week 12 and at 72 weeks after randomization"}]}
{"nct_id":"NCT00879138","start_date":"2008-08-31","phase":"Phase 1/Phase 2","enrollment":27,"brief_title":"Efficacy and Safety of VA106483 in Elderly Males","official_title":"A Double-blind, Placebo-controlled Dose Response Study to Investigate Pharmacodynamics and Pharmacokinetics of Single and Repeated Oral Doses of VA106483 in Elderly Male Subjects","primary_completion_date":"2009-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-03-31","last_update":"2018-10-31","description":"A double blind, placebo-controlled, dose ranging study in males over the age of 65, who have a history of nocturia. The study will investigate pharmacodynamic outcomes (urine volumes and osmolality, circulating coagulation factors and haemodynamics) and pharmacokinetics, of both single and multiple oral doses of VA106483 at three dose levels, under conditions of controlled hydration.","other_id":"483-001","allocation":"Randomized","intervention_model":"Crossover Assignment","masking_description":"Double","sampling_method":"","gender":"Male","minimum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Males 65 years and above with history of nocturia\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any clinically significant concomitant medical disease, condition or abnormal\r\n             laboratory test result\r\n\r\n          -  Participation in any other clinical study within 30 days\r\n\r\n          -  Intake of non-prescription medication within 14 days\r\n      ","sponsor":"Vantia Ltd","sponsor_type":"Industry","conditions":"Nocturia","interventions":[{"intervention_type":"Drug","name":"Drug: VA106483"},{"intervention_type":"Drug","name":"Drug: Sugar pill"}],"outcomes":[{"outcome_type":"primary","measure":"Pharmacodynamic profile of VA106483"},{"outcome_type":"secondary","measure":"Pharmacokinetic profile of VA106483"},{"outcome_type":"secondary","measure":"Safety and tolerability of VA106483"}]}
{"nct_id":"NCT00760201","start_date":"2008-08-31","enrollment":14,"brief_title":"Qualitative Analysis of Hospital Executives, Physician Administrators, and Hospital Legal Counsels' Perceptions of End-of-Life Care","official_title":"Analysis of Hospital Executives, Physician Administrators, and Hospital Legal Counsels Perceptions of End-of-Life Care","primary_completion_date":"2010-08-31","study_type":"Observational","rec_status":"Completed","completion_date":"2010-12-31","last_update":"2011-04-19","description":"Interviewing hospital executives, physician administrators and hospital legal counsel who work in a hospital setting (academic, governmental, private or community hospital) about their perceptions concerning current and future end-of-life care provided in their facilities","other_id":"9360","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":65,"population":"hospital executive, physician administrator or hospital legal counsel in a hospital setting\r\n        (academic, governmental, private or community hospital)","criteria":"\n        Inclusion Criteria:\r\n\r\n        Informant is a hospital executive, physician administrator or hospital legal counsel in a\r\n        hospital setting (academic, governmental, private or community hospital) and is able to\r\n        communicate perceptions verbally through use of English language. All participants will\r\n        likely be nonveterans\r\n\r\n        Exclusion Criteria:\r\n      ","sponsor":"US Department of Veterans Affairs","sponsor_type":"U.S. Fed","conditions":"End of Life Care","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Perceptions of hospital executive, physician administrator or hospital legal counsel in a hospital setting (academic, governmental, private or community hospital)","time_frame":"One year"}]}
{"nct_id":"NCT00768066","start_date":"2008-08-31","phase":"Phase 1/Phase 2","enrollment":65,"brief_title":"The Transendocardial Autologous Cells (hMSC or hBMC) in Ischemic Heart Failure Trial (TAC-HFT)","official_title":"A Phase I/II, Randomized, Double-Blinded, Placebo-Controlled Study of the Safety and Efficacy of Transendocardial Injection of Autologous Human Cells (Bone Marrow or Mesenchymal) in Patients With Chronic Ischemic Left Ventricular Dysfunction and Heart Failure Secondary to Myocardial Infarction.","primary_completion_date":"2012-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-09-30","last_update":"2015-12-14","description":"The technique of transplanting progenitor cells into a region of damaged myocardium, termed cellular cardiomyoplasty, is a potentially new therapeutic modality designed to replace or repair necrotic, scarred, or dysfunctional myocardium. Ideally, graft cells should be readily available, easy to culture to ensure adequate quantities for transplantation, and able to survive in host myocardium; often a hostile environment of limited blood supply and immunorejection. Whether effective cellular regenerative strategies require that administered cells differentiate into adult cardiomyocytes and couple electromechanically with the surrounding myocardium is increasingly controversial, and recent evidence suggests that this may not be required for effective cardiac repair. Most importantly, transplantation of graft cells should improve cardiac function and prevent adverse ventricular remodeling. To date, a number of candidate cells have been transplanted in experimental models, including fetal and neonatal cardiomyocytes, embryonic stem cell-derived myocytes, tissue engineered contractile grafts, skeletal myoblasts, several cell types derived from adult bone marrow, and cardiac precursors residing within the heart itself. There has been substantial clinical development in the use of whole bone marrow and skeletal myoblast preparations in studies enrolling both post-infarction patients, and patients with chronic ischemic left ventricular dysfunction and heart failure. The effects of bone-marrow derived mesenchymal stem cells (MSCs) have also been studies clinically. Currently, bone marrow or bone marrow-derived cells represent highly promising modality for cardiac repair. The totality of evidence from trials investigating autologous whole bone marrow infusions into patients following myocardial infarction supports the safety of this approach. In terms of efficacy, increases in ejection fraction are reported in the majority of the trials. Chronic ischemic left ventricular dysfunction resulting from heart disease is a common and problematic condition; definitive therapy in the form of heart transplantation is available to only a tiny minority of eligible patients. Cellular cardiomyoplasty for chronic heart failure has been studied less than for acute MI, but represents a potentially important alternative for this disease.","other_id":"20070443","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":21,"maximum_age":90,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosis of chronic ischemic left ventricular dysfunction secondary to MI.\r\n\r\n          -  Be a candidate for cardiac catheterization.\r\n\r\n          -  Been treated with appropriate maximal medical therapy for heart failure or\r\n             post-infarction left ventricular dysfunction.\r\n\r\n          -  Ejection fraction less than or equal to 50%.\r\n\r\n          -  Able to perform a metabolic stress test.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Baseline glomerular filtration rate < 45 ml/min/1.73m2.\r\n\r\n          -  Presence of a mechanical aortic valve or heart constrictive device.\r\n\r\n          -  Documented presence of aortic stenosis (aortic stenosis graded as +2 equivalent to an\r\n             orifice area of 1.5cm2 or less).\r\n\r\n          -  Documented presence of moderate to severe aortic insufficiency (echocardiographic\r\n             assessment of aortic insufficiency graded as +2).\r\n\r\n          -  Evidence of a life-threatening arrhythmia (nonsustained ventricular tachycardia  20\r\n             consecutive beats or complete heart block) or QTc interval > 550 ms on screening ECG.\r\n             In addition; patients with sustained or a short run of ventricular tachycardia on ECG\r\n             or 48 hour Ambulatory ECG during the screening period will be removed from the\r\n             protocol.\r\n\r\n          -  Documented unstable angina.\r\n\r\n          -  AICD firing in the past 60 days prior to the procedure.\r\n\r\n          -  Contra-indication to performance of a magnetic resonance imaging scan.\r\n\r\n          -  Be eligible for or require coronary artery revascularization.\r\n\r\n          -  Have a hematologic abnormality as evidenced by hematocrit < 25%, white blood cell <\r\n             2,500/ul or platelet values < 100,000/ul without another explanation.\r\n\r\n          -  Have liver dysfunction, as evidenced by enzymes (ALT and AST) greater than three times\r\n             the ULN.\r\n\r\n          -  Have a coagulopathy condition = (INR > 1.3) not due to a reversible cause.\r\n\r\n          -  Known, serious radiographic contrast allergy.\r\n\r\n          -  Known allergies to penicillin or streptomycin.\r\n\r\n          -  Organ transplant recipient.\r\n\r\n          -  Clinical history of malignancy within 5 years (i.e., patients with prior malignancy\r\n             must be disease free for 5 years), except curatively-treated basal cell carcinoma,\r\n             squamous cell carcinoma, or cervical carcinoma.\r\n\r\n          -  Non-cardiac condition that limits lifespan to < 1 year.\r\n\r\n          -  On chronic therapy with immunosuppressant medication.\r\n\r\n          -  Serum positive for HIV, hepatitis BsAg, or non-viremic hepatitis C.\r\n\r\n          -  Female patient who is pregnant, nursing, or of child-bearing potential and not using\r\n             effective birth control.\r\n      ","sponsor":"University of Miami","sponsor_type":"Other","conditions":"Stem Cell Transplantation|Ventricular Dysfunction, Left","interventions":[{"intervention_type":"Biological","name":"Biological: Autologous human mesenchymal cells (hMSCs)","description":"Participants will receive 40 million cells/mL delivered in either a dose of 0.25 mL per injection for a total of 1 x 108 (100 million) hMSCs x 10 injections or a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."},{"intervention_type":"Biological","name":"Biological: Autologous human bone marrow cells (hBMCs)","description":"Participants will receive 40 million cells/mL delivered in either a dose of 0.25 mL per injection for a total of 1 x 108 (100 million) hBMCs x 10 injections or a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."},{"intervention_type":"Biological","name":"Biological: Placebo","description":"Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."}],"outcomes":[{"outcome_type":"secondary","measure":"Percent Change From Baseline in Scar Mass as a Fraction of Left Ventricle Mass by Cardiac MRI or CT.","time_frame":"12 Months post-catheterization","description":"Data provided are with respect to the change from baseline at 12-months post-catheterization."},{"outcome_type":"primary","measure":"Incidence of TE-SAE Define as Composite of Death, Non-fatal MI, Stroke, Hospitalization for Worsening Heart Failure, Cardiac Perforation, Pericardial Tamponade, Ventricular Arrhythmias >15 Sec. or With Hemodynamic Compromise or Atrial Fibrillation","time_frame":"one month post-catheterization"},{"outcome_type":"secondary","measure":"Serial Troponin Values (Every 12 Hours for the First 48 Hours Post-catheterization).","time_frame":"Measured every 12 hours for the first 48 hours post-catheterization"},{"outcome_type":"secondary","measure":"Serial Creatine Kinase Values (Every 12 Hours for the First 48 Hours Post-catheterization).","time_frame":"Measured every 12 hours for the first 48 hours post-catheterization"},{"outcome_type":"secondary","measure":"Incidence of the Major Adverse Cardiac Events (MACE) Endpoint, Defined as the Composite Incidence of (1) Death, (2) Hospitalization for Heart Failure, or (3) Non-fatal Recurrent MI.","time_frame":"12 months post-catheterization"},{"outcome_type":"secondary","measure":"Ectopic Tissue Formation.","time_frame":"12 months post-catheterization"},{"outcome_type":"secondary","measure":"Number of Deaths","time_frame":"12-months post-catheterization"},{"outcome_type":"secondary","measure":"Change From Baseline in Distance Walked in Six-minutes (Six-minute Walk Test).","time_frame":"12 months post-catheterization","description":"Data provided are with respect to the change from baseline at 12-months post-catheterization."},{"outcome_type":"secondary","measure":"Change From Baseline in the Minnesota Living With Heart Failure (MLHF) Questionnaire Total Score.","time_frame":"12 months post-catheterization","description":"Data provided are with respect to the change from baseline at 12-months post-catheterization. The Minnesota living with heart failure questionnaire uses a 6-point, zero to five, Likert scale. The total score is the sum of the 21 responses. The total score is considered the best measure of how heart failure and treatments impact a patients quality of life. The max score is 105, minimum score is 0. A lower score is considered a better quality of life."}]}
{"nct_id":"NCT00732381","start_date":"2008-08-31","phase":"Phase 3","enrollment":351,"brief_title":"Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05529)","official_title":"Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg QD in the Relief of Nasal Congestion Associated With Seasonal Allergic Rhinitis (SAR)","primary_completion_date":"2008-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-11-30","last_update":"2017-04-13","description":"This study seeks to prospectively demonstrate that Nasonex is better than placebo in relieving nasal congestion in patients with seasonal allergic rhinitis.","other_id":"P05529","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":12,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  A subject must be 12 years of age or older, of either sex, and of any race.\r\n\r\n          -  A subject must have at least a 2-year history of SAR which exacerbates during the\r\n             study season.\r\n\r\n          -  A subject must have a positive skin prick test response to an appropriate seasonal\r\n             allergen at Visit 1.\r\n\r\n          -  A subject must be clinically symptomatic at the Screening and Baseline Visits.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  A subject with a history of severe local reaction(s) or anaphylaxis to skin testing.\r\n\r\n          -  A subject who has had an upper respiratory tract or sinus infection that required\r\n             antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or\r\n             who has had a viral upper respiratory infection within 7 days prior to the Screening\r\n             Visit.\r\n\r\n          -  A subject who has used any drug in an investigational protocol in the 30 days prior to\r\n             the Screening Visit.\r\n\r\n          -  A subject who is participating in any other clinical study.\r\n\r\n          -  A subject who is part of the staff personnel directly involved with this study.\r\n\r\n          -  A subject who is a family member (parent, spouse, or sibling) of the investigational\r\n             study staff.\r\n\r\n          -  A female subject who is breast-feeding, pregnant, or intends to become pregnant.\r\n\r\n          -  A subject previously randomized into this study.\r\n\r\n          -  A subject who has a family member (parent, spouse, or sibling) currently enrolled in\r\n             this study.\r\n      ","sponsor":"Merck Sharp & Dohme Corp.","sponsor_type":"Industry","conditions":"Allergic Rhinitis","interventions":[{"intervention_type":"Drug","name":"Drug: Mometasone furoate nasal spray (MFNS)","description":"MFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD) for 15 days"},{"intervention_type":"Drug","name":"Drug: Matching placebo nasal spray","description":"Matching placebo nasal spray: 2 sprays in each nostril once daily for 15 days"}],"outcomes":[{"outcome_type":"primary","measure":"The Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days","time_frame":"15 days of treatment","description":"Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe symptoms. PRIOR (the subject's status over the previous 12 hours [reflective])"},{"outcome_type":"secondary","measure":"The Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days","time_frame":"15 days of treatment","description":"Total nasal symptom score (TNSS) is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12. PRIOR (the subject's status over the previous 12 hours [reflective])"}]}
{"nct_id":"NCT01797913","start_date":"2008-08-31","phase":"Phase 2","enrollment":70,"brief_title":"The Study of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer","official_title":"The Study of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer","primary_completion_date":"2015-02-28","study_type":"Interventional","rec_status":"Completed","last_update":"2016-02-23","description":"assess the efficacy and safety of gemcitabine in the maintenance treatment of advanced non-small cell lung cancer","other_id":"GEM-CJH","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        18~75 years Patients who were diagnosed by the histologic, cytologic diagnosis of IIIb-IV\r\n        non-small cell lung cancer patients who have acceptted combination chemotherapy based on\r\n        platinum 4 course,SD OR PR,the CR patients should accept 6 course of combination\r\n        chemotherapy.\r\n\r\n        3~8 weeks after patients complete first line chemotherapy(include radiotherapy) Ecog0-2\r\n        Expected life time longer than 3 monthes\r\n\r\n        Normal laboratory values:\r\n\r\n          -  leucocyte  4109/L\r\n\r\n          -  neutrophil  1.5109/L\r\n\r\n          -  platelet  100109/L\r\n\r\n          -  Hemoglobin  10g/L\r\n\r\n          -  ALT and\r\n\r\n          -  AST  2.5ULN ( 5ULN if liver metastasis) Signed written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients have used drugs according to protocol\r\n\r\n          -  Uncontrolled infection of Bacterial or virus or fungal\r\n\r\n          -  Patients with other malignant tumor\r\n\r\n          -  Uncontrolled brain metastases\r\n\r\n          -  Female patients during their pregnant and lactation period, or patients without\r\n             contracep\r\n      ","sponsor":"Fudan University","sponsor_type":"Other","conditions":"THE Efficacy and Safety of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: gemcitabine","description":"gemcitabine1000mg/m2ivgttDAY1&DAY8"}],"outcomes":[{"outcome_type":"primary","measure":"PFS","time_frame":"from the first cycle of treatment (day one) to two month after the last cycle"}]}
{"nct_id":"NCT00789451","start_date":"2008-08-31","phase":"N/A","enrollment":12,"brief_title":"The Effect of Ischaemic-reperfusion on the Endogenous Fibrinolysis in Man","official_title":"The Effect of Ischaemic-reperfusion on the Endogenous Fibrinolysis in Man","primary_completion_date":"2010-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-10-31","last_update":"2010-10-25","description":"Heart attacks are usually caused by a blood clot blocking an artery supplying blood to the heart. Current treatments are designed at relieving this blockage as quickly as possible to minimise damage to the heart muscle. However in restoring the supply of blood local damage known as \"ischaemia-reperfusion injury\" may occur. The aim of this study is to assess how clot forming and clot dissolving pathways are affected during this process, and examine the role of a natural inflammatory hormone, bradykinin. This will help us to understand the mechanism by which ischaemia-reperfusion injury may occur and to devise new treatments for heart attacks.","other_id":"CMP 1","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Basic Science","masking_description":"Double","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy males between 18-65 years of ages, non-smokers.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any concurrent illness or chronic medical condition. Concurrent use of vasoactive\r\n             medication. Smoking history.\r\n      ","sponsor":"University of Edinburgh","sponsor_type":"Other","conditions":"Ischaemic Heart Diseases","interventions":[{"intervention_type":"Procedure","name":"Procedure: Forearm vascular study","description":"Forearm blood flow measured by venous occlusion plethysmography during interarterial infusion of substance P (2,4,8 pmol/min). Venous blood sampling via cannula in antecubital fossa."}],"outcomes":[{"outcome_type":"primary","measure":"Net t-PA release from the endothelium after ischaemia reperfusion","time_frame":"Throughout the study"},{"outcome_type":"secondary","measure":"Change in forearm blood flow after ischaemia reperfusion","time_frame":"throughout the study"},{"outcome_type":"secondary","measure":"Change in platelet-monocyte-binding after ischaemia reperfusion","time_frame":"Throughout the study"}]}
{"nct_id":"NCT00740298","start_date":"2008-07-31","phase":"N/A","enrollment":30,"brief_title":"Thermal Analgesia in Newborns","official_title":"Thermal Analgesia in Newborns","primary_completion_date":"2013-07-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2014-07-31","last_update":"2013-10-09","description":"Newborns routinely experience pain associated with invasive procedures such as blood sampling, immunization, vitamin K injection, or circumcision. Prevention of pain is both an ethical expectation and a professional imperative, as untreated pain has deleterious consequences including altered pain sensitivity in later childhood and may be related to the permanent neuroanatomical and behavioral abnormalities as found in animal models. Moreover, pain is a source of concern and distress for new parents. Yet, pain reducing therapies are often underused for the numerous minor procedures that are a part of routine medical and nursing care for neonates. Growing scientific and clinical literature provides evidence for the effectiveness of natural, non-pharmacological techniques in both animal and human newborns. This study compares the pain reliving effects of sweet taste to the combination of sweet taste and warmth.","other_id":"15480A","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"Single","sampling_method":"","gender":"All","maximum_age":0.00548,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  healthy infants\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  unhealthy infants\r\n      ","sponsor":"University of Chicago","sponsor_type":"Other","conditions":"Pain","interventions":[{"intervention_type":"Other","name":"Other: sucrose","description":"sweet taste"},{"intervention_type":"Other","name":"Other: warmth","description":"warmth"}],"outcomes":[{"outcome_type":"primary","measure":"Decreased behavioral and physiologic indicators of pain","time_frame":"5 minutes"}]}
{"nct_id":"NCT00715000","start_date":"2008-07-31","phase":"Phase 4","enrollment":49,"brief_title":"Oral Versus Intravenous Rehydration for Prevention of Dehydration in Premature Babies, During the First Days of Life.","official_title":"Prevention of Dehydration in Premature Babies Between 32 and 34+6 Gestational Age, Weighing Between 1700 and 2200 g, During the First Days of Life, Using Oral Rehydration Solution in Alternative to Intravenous Infusion","primary_completion_date":"2010-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-08-31","last_update":"2013-04-25","description":"This prospective randomised study comparing administration of a hypo-osmolar oral hydration solution with the classical hydration via IV (intravenous) infusion in premature infants of more than 32 weeks GA (gestational age) aims to determine whether administration of a hypo-osmolar oral hydration solution is as efficient as intravenous infusion.","other_id":"P060208","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":0.61538,"maximum_age":0.65385,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Premature babies between 32 to 34 + 6 weeks of gestation, with a birth weight greater\r\n             than 1700g and less than 2200g under exclusion of SGA (small for gestational age)\r\n             babies with a BW < 10th percentile.\r\n\r\n          -  Infants must be included within the first 12 to 24 hours of life\r\n\r\n          -  Good tolerance to nasogastric milk feeding\r\n\r\n          -  Necessity of additional fluid supply\r\n\r\n          -  Any suspicion of gastro intestinal or metabolic disease\r\n\r\n          -  Maximal humidity in incubator\r\n\r\n          -  Parental consent form\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  suspicion of gastro-intestinal disease,\r\n\r\n          -  severe digestive risks, and metabolic diseases in the family history,\r\n\r\n          -  metabolic or hydro-electrolyte disorders\r\n\r\n          -  other severe diseases\r\n      ","sponsor":"Assistance Publique - Hpitaux de Paris","sponsor_type":"Other","conditions":"Low Birth Weight Infant|Enteral Nutrition","interventions":[{"intervention_type":"Procedure","name":"Procedure: Oral rehydration therapy","description":"oral rehydration solution"},{"intervention_type":"Procedure","name":"Procedure: classical hydration via intravenous infusion","description":"intravenous infusion"}],"outcomes":[{"outcome_type":"primary","measure":"Weight","time_frame":"Day 0 to day 16 or day of recovering original birth day"},{"outcome_type":"secondary","measure":"Weight, length, head circumference and brachial circumference","time_frame":"day 3, 15 of life, and at 37 GA."},{"outcome_type":"secondary","measure":"Weight, Height/length, head circumference and brachial circumference","time_frame":"6 and 12 months"},{"outcome_type":"secondary","measure":"pathologic digestive diseases (enteropathy, NEC…)","time_frame":"J0 to J16"},{"outcome_type":"secondary","measure":"metabolic tolerance during the first week of life: - hypoglycemia - fructose intolerance - bilirubin, electrolytes and creatinin level in blood","time_frame":"during the first week of life"},{"outcome_type":"secondary","measure":"pain and discomfort score (EDIN) evaluated 3 times a day","time_frame":"Day 0 to day 16"},{"outcome_type":"secondary","measure":"secondary IV infusion effects","time_frame":"Day 0 to day 8"},{"outcome_type":"secondary","measure":"number of failure to pick and to perfuse a baby","time_frame":"Day 0 to day 8"},{"outcome_type":"secondary","measure":"ORS culture","time_frame":"in case of infection"},{"outcome_type":"secondary","measure":"Adverse Events","time_frame":"Up to 12 months"},{"outcome_type":"secondary","measure":"Intestinal motility: - gastric residue - first meconium - first normal stool - number of stools during the first days of life","time_frame":"the first two weeks of life"}]}
{"nct_id":"NCT00735449","start_date":"2008-07-31","phase":"Phase 4","enrollment":204,"brief_title":"Comparing Efficacy and Safety of Combigan With Timolol Adjunctive to Xalatan in Glaucoma or Ocular Hypertension Subjects","official_title":"Comparing Efficacy and Safety of Combigan With Timolol Adjunctive to Xalatan in Glaucoma or Ocular Hypertension Subjects","primary_completion_date":"2009-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-12-31","last_update":"2019-04-23","description":"Efficacy and safety evaluation of Combigan with timolol when each is used as adjunctive therapy to Xalatan in subjects with glaucoma or ocular hypertension.","other_id":"GMA-COM-07-XTC","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Be at least 18 years of age\r\n\r\n          -  Give written informed consent\r\n\r\n          -  Be in good general health as determined by your doctor\r\n\r\n          -  Have a diagnosis of unilateral or bilateral glaucoma or ocular hypertension\r\n\r\n          -  If you are a female of child bearing potential, you must be willing to practice\r\n             effective contraception for the duration of the study (i.e., abstinence, spermicide,\r\n             condoms, or birth control pills)\r\n\r\n          -  Understand the study instructions, and be able to follow the study instructions; and\r\n\r\n          -  Be likely to complete the entire study period (12 weeks), including all regularly\r\n             scheduled study visits\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Have any active ocular disease other than glaucoma or ocular hypertension that would\r\n             interfere with study interpretation\r\n\r\n          -  History of severe renal or hepatic impairment\r\n\r\n          -  Subjects with severe cardiovascular disease should not be enrolled unless their\r\n             disease is controlled and clearance has been obtained from the subject's primary care\r\n             physician and/or cardiologist\r\n\r\n          -  Contraindications to beta-adrenoceptor antagonist therapy such as chronic obstructive\r\n             pulmonary disease, bronchial asthma, sinus bradycardia, second and third degree\r\n             atrioventricular block, overt cardiac failure and cardiogenic shock or uncontrolled\r\n             congestive heart failure\r\n\r\n          -  Any systemic disease or clinical evidence of any condition which would make the\r\n             subject, in the opinion of the investigator, unsuitable for the study or could\r\n             potentially confound the study results; and\r\n\r\n          -  Concurrent participation or prior participation in any investigational drug or device\r\n             study within the last 30 days prior to the screening visit\r\n      ","sponsor":"Allergan","sponsor_type":"Industry","conditions":"Glaucoma|Ocular Hypertension","interventions":[{"intervention_type":"Drug","name":"Drug: Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%","description":"1 drop of fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day."},{"intervention_type":"Drug","name":"Drug: timolol maleate 0.5%","description":"1 drop of timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day."},{"intervention_type":"Drug","name":"Drug: latanoprost 0.005%","description":"1 drop of latanoprost 0.005% once nightly."}],"outcomes":[{"outcome_type":"primary","measure":"Mean Intraocular Pressure (IOP) at 10 AM at Week 12","time_frame":"Week 12","description":"Mean IOP at 10 AM at week 12. IOP is a measurement of the fluid pressure in the eye."},{"outcome_type":"secondary","measure":"Mean Intraocular Pressure (IOP) at 10 AM at Week 6","time_frame":"Week 6","description":"Mean IOP at 10 AM at week 6. IOP is a measurement of the fluid pressure inside the eye."},{"outcome_type":"secondary","measure":"Mean Intraocular Pressure (IOP) at 8 AM at Week 12","time_frame":"Week 12","description":"Mean IOP at 8 AM at week 12. IOP is a measurement of the fluid pressure inside the eye."},{"outcome_type":"secondary","measure":"Mean Intraocular Pressure (IOP) at 8 AM at Week 6","time_frame":"Week 6","description":"Mean IOP at 8 AM at week 6. IOP is a measurement of the fluid pressure inside the eye."},{"outcome_type":"secondary","measure":"Number of Subjects With Adverse Events","time_frame":"Week 12","description":"Number of subjects with adverse events, defined as any untoward medical occurrence in a subject, during the study (reported through the week 12 visit)."}]}
{"nct_id":"NCT00615693","start_date":"2008-07-31","phase":"Phase 2","enrollment":13,"brief_title":"Safety, Tolerability, and Efficacy of AEB071 in the Treatment of Uveitis","official_title":"A Multicenter, Single Sequence, Open-label Study to Assess the Tolerability, Safety, and Efficacy of 2 Weeks Oral AEB071 300 mg Twice Daily, Followed by 6 Weeks AEB071 200 mg Twice Daily in the Treatment of Patients With Macular Edema Associated With Non-infectious Intermediate Uveitis, Posterior Uveitis, or Panuveitis","primary_completion_date":"2009-10-31","study_type":"Interventional","rec_status":"Completed","last_update":"2020-12-22","description":"The purpose of this study is to assess the safety, tolerability, and efficacy of AEB071 as a therapy for uveitis. Vision improvement and reduction in the swelling of retina will be measured for the assessment of efficacy.","other_id":"CAEB071A2211","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male and female patients with non-infectious intermediate or posterior uveitis or\r\n             panuveitis in at least one eye, age 18 to 70 years of age inclusive, who are otherwise\r\n             in good health\r\n\r\n          -  Macular edema with average central retinal thickness  250 m\r\n\r\n          -  A vitreous haze score  1, but  3 (based on the National Eye Institute grading\r\n             system)\r\n\r\n          -  Best Corrected Visual Acuity no worse than 20/400 and no better than 20/40\r\n\r\n          -  Daily prednisone dose < 1 mg/kg\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with choroidal neovascularization.\r\n\r\n          -  Patients with the following forms of uveitis:\r\n\r\n               1. Serpiginous choroidopathy\r\n\r\n               2. Acute multifocal placoid pigment epitheliopathy\r\n\r\n               3. White dot retino-choroidopathies (e.g., multiple evanescent white dot syndrome\r\n                  (MEWDS) or multifocal choroiditis)\r\n\r\n          -  Macular edema associated with other ocular disease (e.g., diabetic retinopathy)\r\n\r\n          -  Patients who had a prior vitrectomy\r\n\r\n          -  Any eye condition that may affect the evaluation of visual acuity and retinal\r\n             thickness\r\n\r\n          -  Concurrent use of certain immunosuppressive agents (specific washout periods for\r\n             different agents are defined in the protocol)\r\n\r\n          -  Use of systemic medications known to be toxic to the lens, retina, or optic nerve\r\n             (e.g. deferoxamine, chloroquine, and ethambutol) currently or in the past 6 months\r\n\r\n          -  Other protocol-defined inclusion/exclusion criteria may apply\r\n      ","sponsor":"Novartis","sponsor_type":"Industry","conditions":"Uveitis|Posterior Uveitis|Panuveitis","interventions":[{"intervention_type":"Drug","name":"Drug: AEB071"}],"outcomes":[{"outcome_type":"primary","measure":"Safety and tolerability of AEB071","time_frame":"Baseline/Day 1 to Week 8 (Day 56) (end of study)"},{"outcome_type":"secondary","measure":"Change in the degree of inflammation in the study eye","time_frame":"Baseline/Day 1, Week 8 (Day 56)/end of study"},{"outcome_type":"secondary","measure":"Change in the visual acuity of the study eye","time_frame":"Baseline/Day 1, Week 8 (Day 56)/end of study"},{"outcome_type":"secondary","measure":"Change in macular edema in the study eye","time_frame":"Baseline/Day 1, Week 8 (Day 56)/end of study"}]}
{"nct_id":"NCT00735306","start_date":"2008-07-31","phase":"Phase 1","enrollment":12,"brief_title":"Phase I/II Trial of Radiation, Avastin and Tarceva for Pancreatic Adenocarcinoma","official_title":"A Phase I/II Trial of Radiation, Avastin and Tarceva for Resectable or Locally Advanced Pancreatic Adenocarcinoma","primary_completion_date":"2011-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-10-31","last_update":"2015-06-18","description":"The primary purpose of this trial is to define the maximum tolerated and/or recommended phase II dose of the combination of Avastin and Tarceva in patients undergoing radiation therapy for carcinoma of the pancreas. An additional primary objective is to describe the frequency and nature of grade III/IV and grade I/II toxicities associated with this regimen. Secondary objectives include describing 1-year disease-free survival and overall survival rates as well as to estimate clinical and pathologic complete response rates associated with this regimen.","other_id":"Pro00001597","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age > 18 years\r\n\r\n          -  Histologically and/or cytologically confirmed adenocarcinoma of the pancreas, T1-4,\r\n             N0-1, M0. Patients should have disease for which combined modality therapy is\r\n             indicated.\r\n\r\n          -  Performance status 0-2\r\n\r\n          -  Life expectancy > 3 months\r\n\r\n          -  Adequate hematologic, renal, hepatic function\r\n\r\n          -  Calculated creatinine Cl > 50 mL/min\r\n\r\n          -  Use of effective means of contraception in patients of child-bearing potential.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  No prior therapy for pancreatic cancer\r\n\r\n          -  Previous treatment with bevacizumab or erlotinib\r\n\r\n          -  Evidence of duodenal invasion or gastric outlet obstruction\r\n\r\n          -  Presence of bleeding diathesis or coagulopathy\r\n\r\n          -  History or prior arterial thrombotic event\r\n\r\n          -  Conditions leading to inadequate gastrointestinal tract absorption\r\n\r\n          -  Poorly controlled diarrhea .\r\n\r\n          -  Presence of baseline proteinuria or renal dysfunction (CrCl < 50 (Cockcroft-Gault\r\n             equation)\r\n\r\n          -  Inadequately controlled hypertension\r\n\r\n          -  New York Heart Association (NYHA) Grade II or greater congestive heart failure\r\n\r\n          -  Clinically significant peripheral vascular disease\r\n\r\n          -  Presence of central nervous system or brain metastases\r\n\r\n          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days\r\n             prior to Day 0, anticipation of need for major surgical procedure during the course of\r\n             the study\r\n\r\n          -  Minor surgical procedures such as fine needle aspirations or core biopsies within 7\r\n             days prior to Day 0\r\n\r\n          -  Pregnant or lactating females\r\n\r\n          -  History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess\r\n             within 6 months prior to Day 0\r\n\r\n          -  Serious, non-healing wound, ulcer, or bone fracture\r\n\r\n          -  Inability to comply with study and/or follow-up procedures\r\n\r\n          -  Treatment for other carcinomas within the last five years, except cured non-melanoma\r\n             skin cancer, curatively treated in-situ cervical cancer, or localized prostate cancer\r\n             with a current PSA of <1.0 mg/dL on 2 successive evaluations, at least 3 months apart,\r\n             with the most recent evaluation no more than 4 weeks prior to entry.\r\n\r\n          -  Comorbid conditions that would complicate safety or compliance\r\n      ","sponsor":"Duke University","sponsor_type":"Other","conditions":"Pancreatic Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Avastin","description":"Avastin 10 mg/kg IV on days 1, 15 and 29 Begins the first day of radiation therapy"},{"intervention_type":"Drug","name":"Drug: Tarceva","description":"Daily by mouth per assigned dose, for 5.5 weeks Begins the first day of radiation therapy"},{"intervention_type":"Radiation","name":"Radiation: Radiation Therapy","description":"Radiation to the pancreas Monday through Friday for 28 treatments"}],"outcomes":[{"outcome_type":"primary","measure":"Tarceva Maximum Tolerated Dose in mg","time_frame":"1 yr","description":"Tarceva maximum tolerated dose in mg"},{"outcome_type":"secondary","measure":"Number of Dose Limiting Toxicities","time_frame":"Within 30 days of completing radiation"},{"outcome_type":"secondary","measure":"One Year Overall Survival From Time of Diagnosis","time_frame":"1 year","description":"One year survival from time of diagnosis for patients who completed this regimen"}]}
{"nct_id":"NCT00719316","start_date":"2008-07-31","phase":"Phase 4","enrollment":30,"brief_title":"Aliskiren and Muscle Sympathetic Nerve Activity","official_title":"Effect of Aliskiren on Muscle Sympathetic Nerve Activity (MSNA) in Hypertensive Patients With Chronic Kidney Disease","primary_completion_date":"2009-07-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2010-01-31","last_update":"2010-01-14","description":"The central hypothesis of this project is that Aliskiren causes a substantial decrease in MSNA in hypertensive patients with CKD.","other_id":"NL19926.041.07","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":25,"maximum_age":95,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with stable chronic kidney disease and hypertension: i.e. using\r\n             antihypertensive drugs and/or blood pressure > 145/90 mmHg when off medication.\r\n\r\n          -  Patients on ACE inhibitor or ARB\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with diabetes mellitus\r\n\r\n          -  Patients on renal replacement therapy\r\n\r\n          -  Pregnant patients Using of antihypertensive which cannot be stopped\r\n\r\n          -  Patients on immunosuppressive therapy and active nephrotic syndrome\r\n      ","sponsor":"UMC Utrecht","sponsor_type":"Other","conditions":"Chronic Kidney Disease|Hypertension|Muscle Sympathetic Nerve Activity","interventions":[{"intervention_type":"Drug","name":"Drug: Aliskiren","description":"Aliskiren 300mg per day for 6 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Normalisation of muscle sympathetic nerve activity","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Blood pressure and Blood tests","time_frame":"1 year"}]}
{"nct_id":"NCT00672347","start_date":"2008-07-31","phase":"Phase 1/Phase 2","enrollment":80,"brief_title":"Clonidine and Morphine in Caudal Anesthesia","official_title":"Comparison of Clonidine and Morphine Plus Bupivacaine in Caudal Peridural Anesthesia for Postoperative Analgesia After Pediatric Urogenital Surgery","primary_completion_date":"2008-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-09-30","last_update":"2010-03-19","description":"Hypothesis: The combined use of Clonidine and Morphine in caudal anesthesia provides better postoperative analgesia than either drug alone after urogenital pediatric surgery.","other_id":"210665","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":1,"maximum_age":10,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Urogenital pediatric surgery\r\n\r\n          -  Status physical(ASA) 1 and 2\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Cutaneous infection in puncture site\r\n      ","sponsor":"Federal University of Minas Gerais","sponsor_type":"Other","conditions":"Postoperative Pain","interventions":[{"intervention_type":"Drug","name":"Drug: Clonidine","description":"1 mcg/kg"},{"intervention_type":"Drug","name":"Drug: Morphine","description":"20 mcg/kg"},{"intervention_type":"Drug","name":"Drug: Bupivacaine plus clonidine and morphine","description":"bupivacaine 0,166% 1 ml/kg\r\nclonidine 1 mcg/kg\r\nmorphine 20 mcg/kg"},{"intervention_type":"Drug","name":"Drug: Bupivacaine","description":"Caudal anesthesia with bupivacaine 0,166% 1 ml/kg"}],"outcomes":[{"outcome_type":"primary","measure":"The overall postoperative consumption of analgesics.","time_frame":"24 hours"},{"outcome_type":"secondary","measure":"The peroperative consumption of volatile anesthetics.","time_frame":"3 hours"},{"outcome_type":"secondary","measure":"The peroperative Bispectral Index measure.","time_frame":"3 hours"},{"outcome_type":"secondary","measure":"Postoperative Wong-Baker faces scale","time_frame":"24 hours"},{"outcome_type":"secondary","measure":"Postoperative pain and discomfort score scale","time_frame":"24 hours"}]}
{"nct_id":"NCT00862953","start_date":"2008-07-31","phase":"N/A","enrollment":317,"brief_title":"Study to Assess the Effects of High Protein Diet in Obesity, the LOWER Study","official_title":"The Lifestyle, OverWeight, Energy Restriction Study","primary_completion_date":"2010-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-10-31","last_update":"2012-02-22","description":"This program is carried out in a dedicated outpatient-clinic in the city of Hengelo for the evaluation and treatment of subjects with obesity. The program puts emphasis on intervention with appropriate diet and physical exercise, and supports the patients in achieving long-term behaviour changes. Interventions which are compared are normal vs high protein/low carb diets.","other_id":"BWO08-002","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Obesity with BMI > 27 kg/m2\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Recent loss of body weight (>10%)\r\n\r\n          -  Underlying malignancy, HIV infection, psychiatric disease\r\n\r\n          -  Pregnancy or breast feeding\r\n      ","sponsor":"B.H.R. Wolffenbuttel","sponsor_type":"Other","conditions":"Obesity","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Normal protein energy-restricted","description":"Normal protein diet energy restricted"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: High protein energy-restricted","description":"High protein diet, with either low or normal carbohydrate content"}],"outcomes":[{"outcome_type":"primary","measure":"Body weight","time_frame":"1 year"}]}
{"nct_id":"NCT00703456","start_date":"2008-06-30","phase":"N/A","enrollment":0,"brief_title":"The Effect of Balance Training on Unloading Reaction in Individuals With Functional Ankle Instability","official_title":"The Effect of Balance Training on Unloading Reaction in Individuals With Functional Ankle Instability","primary_completion_date":"2009-05-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2009-05-31","last_update":"2016-04-19","description":"The aim of this study is to determine the effect of a balance training intervention on the change in hyper-reactivity to unloading reaction, ankle joint laxity, ankle joint proprioception and evertor muscle weakness in individuals with functional ankle instability (FAI) using quantitative biomechanical and neuromuscular measurements. We hypothesize that experimental FAI group will demonstrate a significant decline in unloading reaction following balance training while FAI control group will not show a significant decline in unloading reaction without training. We further hypothesize that experimental FAI group will demonstrate a significant improvement in the FAI score after the balance training measured by Ankle Instability questionnaire. Following balance training, there will be a significant correlation between the change in FAI score and change in the unloading reaction in the experimental group.","other_id":"10866","allocation":"Randomized","intervention_model":"Parallel Assignment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  aged from 18 to 45 years\r\n\r\n          -  unilateral functional ankle instability (grade II or III)\r\n\r\n          -  at least four weeks after acute lateral ankle sprain\r\n\r\n          -  ongoing symptom of ankle \"giving way\" episode during functional activities\r\n\r\n          -  active in exercise at least 2 hour per week\r\n\r\n          -  seeking medical treatment for ankle symptoms\r\n\r\n          -  being able to complete the test and training tasks.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  severe ankle pain and swelling\r\n\r\n          -  ankle surgery in either leg\r\n\r\n          -  gross limitation in ankle range of motion\r\n\r\n          -  lower extremity injury other than lateral ankle sprain in past 12 weeks, (5) current\r\n             enrollment in formal rehabilitation program\r\n\r\n          -  history of insulin-dependent diabetes\r\n\r\n          -  any systemic disease that might interfere with sensory input or muscle function of the\r\n             lower extremity\r\n\r\n          -  any joint disease or bony fracture in the lower extremity\r\n\r\n          -  any previous experience of intolerance to electrical stimulation.\r\n      ","sponsor":"University of Kansas Medical Center","sponsor_type":"Other","conditions":"Ankle Injury","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Balance Training","description":"balance training three days per week for 4 weeks during single limb standing"}],"outcomes":[{"outcome_type":"primary","measure":"Vertical force variation","time_frame":"6 weeks"},{"outcome_type":"secondary","measure":"ankle inversion flexibility, ankle proprioception, ankle evertor strength, modified cumberland ankle instability tool questionnaire","time_frame":"6 weeks"}]}
{"nct_id":"NCT00706277","start_date":"2008-06-30","phase":"Phase 4","enrollment":60,"brief_title":"Effect of Total Intravenous Anesthesia and Balanced Anesthesia on Postoperative Lung Function","official_title":"Effect of Total Intravenous Anesthesia and Balanced Anesthesia on Postoperative Lung Function","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-12-31","last_update":"2009-02-10","description":"The aim of the study is to investigate the effects of total intravenous anesthesia (TIVA; propofol, remifentanil) and balanced anesthesia (BAL; induction with propofol and fentanyl; maintenance of anesthesia with sevoflurane and nitrous oxide) on pulmonary function 30 minutes after emergence from the general anesthesia.","other_id":"2007-007161-25","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  ASA 1-2\r\n\r\n          -  BMI normal\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  lung disease\r\n\r\n          -  Nicotine abuse\r\n      ","sponsor":"Medical University Innsbruck","sponsor_type":"Other","conditions":"Lung Function","interventions":[{"intervention_type":"Drug","name":"Drug: propofol","description":"propofol 2mg/kg for induction of anesthesia; followed by propofol 6 mg/kg/hour"},{"intervention_type":"Drug","name":"Drug: propofol","description":"propofol 2mg"},{"intervention_type":"Drug","name":"Drug: remifentanil","description":"remifentanil 0,25mcg/kg/hour"},{"intervention_type":"Drug","name":"Drug: fentanyl","description":"fentanyl 100mcg"},{"intervention_type":"Drug","name":"Drug: Sevoflurane/Nitrous Oxide","description":"maintenance of anesthesia with sevoflurane and nitrous oxide"}],"outcomes":[{"outcome_type":"primary","measure":"FEV1 forced expiratory volume; FVC forced vital capacity","time_frame":"preoperative, 30 minutes postoperative"}]}
{"nct_id":"NCT00666965","start_date":"2008-06-30","phase":"Phase 2","enrollment":230,"brief_title":"A Placebo-Controlled Study for SPM 962 in Restless Legs Syndrome (RLS) Patients","official_title":"A Placebo-Controlled Study for SPM 962 in RLS Patients","primary_completion_date":"2009-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-08-31","last_update":"2014-04-25","description":"The primary objective of this study is to investigate efficacy and safety of SPM 962 in Japanese RLS patients in a multi-center, placebo-controlled double-blind parrallel group comparative study following once-daily multiple transdermal doses of SPM 962 within a range of 2.25 to 6.75 mg/day. Recommended maintainance dose range is also to be investigated.","other_id":"243-07-003","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":79,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Subject is 20 and more and less than 80 years of age and is able to think about\r\n             her/his participation at the time of informed consent.\r\n\r\n          2. Subject meets the diagnosis of idiopathic RLS based on the 4 cardinal clinical\r\n             features according to the IRLSSG/NIH.\r\n\r\n          3. The following subject will be included in the study\r\n\r\n               -  Subject is not currently receiving treatment for RLS.\r\n\r\n               -  Subject has previously received treatment of either L-dopa or dopamine agonists\r\n                  and efficacy was observed in either of drugs.\r\n\r\n          4. At baseline, subject has a score of  15 on the IRLS sum score and RLS symptoms occur\r\n             twice and more a week (score 2 in IRLS Question 7)\r\n\r\n          5. Subject has a score of  4 on the CGI Severity score at baseline\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Subject has secondary RLS in association with renal impairment such as uremiairon\r\n             deficiency anemia, and drug associated symptoms.\r\n\r\n          2. Subject has, is suspected of having or has a history of sleep disorders such as sleep\r\n             apnea syndrome, narcolepsy, sleep attacks/sudden onset of sleep.\r\n\r\n          3. Subject has additional clinically relevant concomitant diseases or symptoms such as\r\n             polyneuropathy (including diabetic neuropathy), akathisiaclaudication\r\n             varicosesmuscle fasciculationpainful legs moving toes and radiculopathy.\r\n\r\n          4. Subject has other central nervous diseases like Parkinson's disease, dimentia,\r\n             progressive supranuclear paresis, multisystem atrophy, Huntington's Chorea,\r\n             amyotrophic lateral sclerosis, or Alzheimer's disease.\r\n\r\n          5. At screening or baseline, subject has psychiatric condition like confusion,\r\n             hallucination, delusion, excitation, deliria, abnormal behaviour.\r\n\r\n          6. Subject has orthostatic hypotension or systolic BP marks  100 mm Hg and with a\r\n             decrease of BP from supine to standing position of  30 mm Hg.\r\n\r\n          7. Subject has a history of epilepsy, convulsion etc.\r\n\r\n          8. Subject has serious cardiac dysfunction and/or arrhythmias (e.g., congestive heart\r\n             failure Class III or IV by NYHA, myocardial infarction, angina pectoris, conduction\r\n             system dysregulations, second or third degree AV block, complete left bundle branch\r\n             block, sick-sinus-syndrome, ventricular fibrillation within twelve months prior to\r\n             enrollment).\r\n\r\n          9. Subject has arrhythmia and receiving Class Ia antiarrhythmic drugs(e.g., quinidine,\r\n             procainamide), Class III antiarrhythmic drugs (e.g., amiodarone, sotalol)\r\n\r\n         10. At screening and baseline, subject develops serious ECG abnormality. Subjects has\r\n             QTc-interval >450 msec twice at screening. Subject has a the average QTc-interval from\r\n             two ECGs >450 msec in males and >470 msec in females at baseline.\r\n\r\n         11. Subject has long QT syndrome congenital.\r\n\r\n         12. Subject has a serum potassium level < 3.5 mEq/L at screening.\r\n\r\n         13. Subject has a total bilirubin 3.0 mg/dL or AST(GOT) and/or ALT(GPT) greater than 2.5\r\n             times the upper limit of the reference range (or 100 IU/L) at screening.\r\n\r\n         14. Subject has BUN  30 mg/dL or serum creatinine 2.0 mg/dl at screening.\r\n\r\n         15. Subject has a history of allergic reaction to topical agents such as transdermal\r\n             patch.\r\n\r\n         16. Subject is pregnant or nursing or woman who plans pregnancy during the trial.\r\n\r\n         17. Subject pursues shift work or is subject to other continuous non-disease-related life\r\n             conditions which do not allow regular sleep at night.\r\n\r\n         18. Subject has autoimmune disease, chronic active hepatitis or immune deficiency\r\n             disorder.\r\n\r\n         19. Subject has a malignant neoplastic disease requiring therapy within twelve months\r\n             prior to screening.\r\n\r\n        19. Subject received an investigational drug from other clinical trial within the last 12\r\n        months prior to baseline.\r\n\r\n        20. Subject is judged to be inappropriate for this trial by investigator on the other than\r\n        above.\r\n      ","sponsor":"Otsuka Pharmaceutical Co., Ltd.","sponsor_type":"Industry","conditions":"Idiopathic Restless Legs Syndrome","interventions":[{"intervention_type":"Drug","name":"Drug: SPM 962","description":"transdermal application, 1 time per day, 0-6.75 mg/body, titration, 6weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Change of International Restless Legs Syndrome Study Group Rating Scale (IRLS) Score From the Baseline to the End of Titration/Maintenance Period","time_frame":"Baseline, end of maintenance period at 6 weeks","description":"IRLS is a scale for assessing severity of restless legs syndrome symptoms. IRLS consists of ten questions. Each question is scored from 4 for the first (top) answer (usually 'very severe') to 0 for the last answer (usually none).\r\nThe sum of the score of each question serves as the scale score.\r\nThe scale scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40). A decrease in the scores means improvement."},{"outcome_type":"secondary","measure":"Clinical Global Impression (CGI) Severity","time_frame":"Baseline, 2 weeks, 4 weeks and 6 weeks. The data at 6 weeks after dosing is shown.","description":"CGI is a clinician-reported scale for assessing severity of illness.\r\nThe sale scoring criteria are 1: Normal, not at all ill, 2: Borderline ill, 3: Mildly ill, 4: Moderately ill, 5: Markedly ill, 6: Severely ill, 7: Among the most extremely ill patients."},{"outcome_type":"secondary","measure":"Patient Global Impression (PGI) Improvement","time_frame":"Baseline, 4 weeks and 6 weeks. The data at 6 weeks after dosing is shown.","description":"The PGI-I is a self-rated 7-point scale, with scores ranging from 1 (very much improved) to 7 (very much worse), that assesses the improvement or worsening of a patient's illness relative to baseline at the beginning of the intervention. Scores: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse. Moderate and marked improvement = score of 1 or 2, Without improvement = score of 4, Marked and moderate aggravation = score of 6 or 7."},{"outcome_type":"secondary","measure":"The Pittsburgh Sleep Quality Index (PSQI)","time_frame":"Baseline, every two weeks","description":"PSQI is a scale for assessing severity of sleep disorders. The score ranges from 0 to 21. 0 indicates \"no difficulty\" and 21 indicates \"severe difficulty\". A decrease in the scores means improvement.\r\nThe data at 6 weeks after dosing is shown."},{"outcome_type":"secondary","measure":"Medical Outcome Study (MOS) Short-Form 36-Item Health Survey (SF-36)","time_frame":"Baseline, every two weeks","description":"Mean Change from baseline in MOS Short Form SF-36 to 6 weeks after dosing. SF-36 is a scale for assessing health status in clinical practice and research. The scores of 36 questions are summarized into 7 sub-scales. In each sub-scale which range is 0-100, a higher score indicates a better health status. Thus a increase in the scores means improvement."},{"outcome_type":"secondary","measure":"IRLS Each Parameter","time_frame":"Baseline, every two weeks","description":"IRLS is a scale for assessing severity of restless legs syndrome symptoms. IRLS consists of ten questions. Each question is scored from 4 for the first (top) answer (usually 'very severe') to 0 for the last answer (usually none).\r\nThe sum of the score of each question serves as the scale score. The scale scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40). A decrease in the scores means improvement.\r\nThe percentage of subjects with -3 or -4 changes from baseline in each parameter at 6 weeks after dosing is shown."}]}
{"nct_id":"NCT00717886","start_date":"2008-06-30","phase":"N/A","enrollment":13,"brief_title":"Upper Extremity Lymphatic Mapping for Breast Cancer Patients","official_title":"Upper Extremity Lymphatic Mapping for Breast Cancer Patients: A Pilot Study","primary_completion_date":"2009-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-10-31","last_update":"2015-11-20","description":"This study is being done to see if lymph nodes that drain the arm also drain the breast. An axillary lymph node dissection removes lymph nodes under the arm. It is done to help prevent cancer cells from spreading to the rest of the body. Usually, about 12 to 15 nodes are removed. They are then examined to see if they have cancer cells. Removing these lymph nodes has some side effects. The most common is lymphedema. This is the build-up of fluid in the arm. This study will tell us if it may be possible in the future to identify lymph nodes that just drain the arm. Leaving those nodes may help to reduce the rate of lymphedema for future patients.","other_id":"08-051","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":21,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Females with Stage II invasive breast cancer and documented axillary metastases by\r\n             core biopsy, clinical examination, or fine-needle aspiration who are scheduled to\r\n             undergo an ALND.\r\n\r\n          -  Females > 21 years of age\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior ipsilateral axillary surgery\r\n\r\n          -  Prior ipsilateral axillary radiation\r\n\r\n          -  Prior ipsilateral breast cancer\r\n\r\n          -  Prior ipsilateral breast radiation\r\n\r\n          -  Allergy to isosulfan blue dye\r\n\r\n          -  History of ipsilateral upper extremity lymphedema\r\n\r\n          -  Prior history of surgical excision of the upper outer quadrant of the ipsilateral\r\n             breast\r\n\r\n          -  Prior history of neoadjuvant chemotherapy for current breast cancer\r\n\r\n          -  Bulky axillary disease at presentation (N2)\r\n      ","sponsor":"Memorial Sloan Kettering Cancer Center","sponsor_type":"Other","conditions":"Breast Cancer|Axillary Lymph Node Dissection","interventions":[{"intervention_type":"Radiation","name":"Radiation: isosulfan blue dye","description":"At the time of surgery, each patient will undergo a subareolar injection of isosulfan blue dye into the ipsilateral breast as routinely performed during a sentinel lymph node mapping for breast cancer. The surgeon will then perform an axillary lymph node dissection in the usual, routine manner. The above differs from standard of care in that patients scheduled for an upfront axillary dissection do not routinely undergo sentinel lymph node mapping- therefore these patients would not normally get any isotope or TSC injections since they already need an ALND. Second, standard sentinel lymph node mapping involves injection of TSC into the affected breast the day prior to surgery or 3 hours before surgery versus injection of TSC into the ipsilateral upper extremity. The protocol specifies \"day of\" mapping for patient convenience."}],"outcomes":[{"outcome_type":"primary","measure":"Number and Prevalence of Metastases of Blue Nodes in the ALND Specimen (Nodes Draining the Breast).","time_frame":"2 years"}]}
{"nct_id":"NCT00912262","start_date":"2008-06-30","phase":"Phase 1","enrollment":36,"brief_title":"A Study to Investigate the Tolerability and Effects on Epidermal Nerve Fiber Density of Multiple Low-Concentrations of NGX-1998 in Healthy Volunteers","official_title":"A Randomized, Single Blind Study to Investigate the Tolerability and Effects on Epidermal Nerve Fiber Density of Multiple Low-Concentrations of Capsaicin Topical Liquid NGX-1998 in Healthy Volunteers","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-11-30","last_update":"2009-06-03","description":"The purpose of this single-blinded study in healthy volunteers is to select a Low-Concentration Capsaicin Topical Liquid (LC-CTL) to serve as a control formulation in the further clinical development of Capsaicin Topical Liquid, NGX-1998 (10% w/w). The goal is to identify a low concentration formulation that will not reduce ENFD in healthy normal volunteers when compared to NGX-1998 (10% w/w) but would still produce some local capsaicin-related application site responses (e.g. erythema, heat sensation or pain) when applied.","other_id":"C203","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        To be included in the study, subjects must meet all of the Inclusion Criteria:\r\n\r\n          -  18 to 40 years of age, inclusive. Male and female subjects.\r\n\r\n          -  Be in good health\r\n\r\n          -  Have intact, unscarred skin over the thighs\r\n\r\n          -  Agree not to use topically-applied products containing non-steroidal anti-inflammatory\r\n             drugs, menthol, methyl salicylate, local anesthetics, steroids or capsaicin anywhere\r\n             on the thighs for the duration of the study\r\n\r\n          -  Female subjects of child bearing potential must not be breast-feeding and must have a\r\n             negative serum beta human chorionic gonadotropin (hCG) pregnancy test performed within\r\n             7 days prior to the Application Visit (Day 0)\r\n\r\n          -  All subjects, including early terminations, must be willing to use effective methods\r\n             of birth control and/or refrain from participating in a conception process during the\r\n             study and for 30 days following experimental drug exposure\r\n\r\n          -  Subjects must be willing and able to comply with protocol requirements for the\r\n             duration of study participation. Requirements include but are not limited to attending\r\n             all study visits and refraining from extensive travel during study participation\r\n\r\n          -  Subjects must sign an informed consent form that has been approved by the\r\n             Investigator's Institutional Review Board (IRB) to participate in this study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any dermatological condition(s) that in the judgment of the Principal Investigator has\r\n             the potential to disrupt skin integrity, healing, or alter sensory function on the\r\n             thighs.\r\n\r\n          -  Any skin infection, skin irritation (e.g., poison oak), history of eczema, trauma or\r\n             burn (including sunburn) on the thighs within 30 days preceding the Application Visit\r\n             (Day 0).\r\n\r\n          -  Any medical history of painful conditions, surgery, or injury involving or affecting\r\n             the thighs, including but not limited to prior orthopedic surgery, lumbosacral disc\r\n             disease, sciatica, and hip or femur fracture.\r\n\r\n          -  Any medical history of known or suspected body system abnormalities, including but not\r\n             limited to diabetes, hypothyroidism, asthma or any form of peripheral or central\r\n             nervous system disease.\r\n\r\n          -  Subjects with congenital, idiopathic, or drug-induced methemoglobinemia.\r\n\r\n          -  Use of any systemic medications that interact with the peripheral nervous system,\r\n             including beta adrenergic blockers, alpha adrenergic blockers, anticonvulsant drugs,\r\n             antidepressant drugs or opioids within 30 days prior to the Application Visit (Day 0).\r\n\r\n          -  Current use of any class III anti-arrhythmic drugs (eg, amiodarone, bretylium,\r\n             sotalol, dofetilide).\r\n\r\n          -  Use of any topically-applied product, including prescription or over the-counter (OTC)\r\n             analgesic creams/lotions/patches, non steroidal anti-inflammatory drugs,\r\n             counterirritants, local anesthetics, steroids or capsaicin on the thighs within 30\r\n             days preceding the Application Visit (Day 0).\r\n\r\n          -  Currently taking any prescription medication except for oral, transdermal or injected\r\n             contraceptives.\r\n\r\n          -  Requirement for ongoing or periodic pain medication for any chronic or recurrent\r\n             medical condition. Refer to Section 3.4 for additional information about concomitant\r\n             medications.\r\n\r\n          -  Participation in another drug research study within 30 days preceding the Application\r\n             Visit (Day 0).\r\n\r\n          -  Diagnosis of human immunodeficiency virus (HIV) infection, according to medical\r\n             history and/or self-report; or Positive test result on the HIV-1 blood test performed\r\n             at the Screening Visit (ICMA with Western Blot confirmation).\r\n\r\n          -  History or current substance abuse including alcoholism/alcohol abuse.\r\n\r\n          -  Positive test result on the urine drug screen for barbiturates, benzodiazepines,\r\n             tricyclic anti-depressants, propoxyphene, opioids, cannabis, phencyclidine (PCP),\r\n             cocaine and amphetamines performed at the Screening Visit.\r\n\r\n          -  History of hypersensitivity to capsaicin (i.e., chili peppers or OTC capsaicin\r\n             products), local anesthetics (including lidocaine and prilocaine) or any components of\r\n             the Capsaicin Topical Liquids, Cleansing Gel or the lidocaine 2.5% / prilocaine 2.5%\r\n             topical anesthetic cream.\r\n\r\n          -  Any clinically-significant abnormal laboratory test at the Screening Visit.\r\n\r\n          -  Clinically-significant abnormal 12-Lead ECG at the Screening Visit\r\n      ","sponsor":"NeurogesX","sponsor_type":"Industry","conditions":"Pain","interventions":[{"intervention_type":"Drug","name":"Drug: Capsaicin Topical Liquid"}],"outcomes":[{"outcome_type":"primary","measure":"To assess the potential differences in the effects of 15-minute treatments of several Low-Concentration Capsaicin Topical Liquids, compared to 15-minute treatments of NGX-1998 and a control, Capsaicin Topical Liquid Vehicle, as quantified by Protein Gene"}]}
{"nct_id":"NCT00714701","start_date":"2008-06-30","enrollment":631,"brief_title":"Screening for Early Pancreatic Neoplasia (Cancer of the Pancreas Screening or CAPS4 Study)","official_title":"Screening for Early Pancreatic Neoplasia (Cancer of the Pancreas Screening or CAPS4 Study)","primary_completion_date":"2016-07-31","study_type":"Observational","rec_status":"Completed","completion_date":"2016-07-31","last_update":"2018-09-07","description":"CAPS4 is a study at Johns Hopkins Hospital to study the diagnosis and long-term outcomes of screening patients with an increased inherited risk for pancreatic cancer.","other_id":"J0139 00-04-14-10","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":100,"population":"asymptomatic high risk patients","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. High Risk Group 1 (familial Peutz-Jeghers syndrome):\r\n\r\n               1. At least 30 years old and <100 years old, and\r\n\r\n               2. at least 2 of 3 criteria diagnostic of Peutz-Jeghers syndrome (characteristic\r\n                  intestinal hamartomatous polyps, mucocutaneous melanin deposition, or family\r\n                  history of Peutz-Jeghers syndrome)\r\n\r\n               3. known STK-11 gene mutation carrier\r\n\r\n          2. High Risk Group 2 (familial pancreatic cancer relatives):\r\n\r\n               1. > 50 years old or 10 years younger than the age of youngest relative with\r\n                  pancreatic cancer, and < 80 years old\r\n\r\n               2. come from a family with 2 or more members with a history of pancreatic cancer (2\r\n                  of which have a first-degree relationship consistent with familial pancreatic\r\n                  cancer), and\r\n\r\n               3. have a first-degree relationship with at least one of the relatives with\r\n                  pancreatic cancer.\r\n\r\n             If there are 2 or more affected blood relatives, at least 1 must be a first-degree\r\n             relative of the individual being screened\r\n\r\n          3. High Risk Group 3 (germline mutation carriers):\r\n\r\n               1. > 40 years old or 10 years younger than the age of the youngest relative with\r\n                  pancreatic cancer, and< 80 years old\r\n\r\n               2. patient is carrier of a known BRCA1, BRCA2, PALB2, or FAMMM (p16/CDKN2A)\r\n                  mutation, and there is > 1 pancreatic cancer in the family, one of whom is a\r\n                  first- or second-degree relative of the subject to be screened.\r\n\r\n               3. Hereditary pancreatitis syndrome\r\n\r\n          4. High Risk Group 4 (young-onset pancreatic cancer relative):\r\n\r\n               1. > 50 years old or 10 years younger than the age of youngest relative with\r\n                  pancreatic cancer, and < 80 years old\r\n\r\n               2. have a first-degree relationship with at least one relative with young-onset\r\n                  pancreatic cancer ( age of onset < 50 years)\r\n\r\n          5. High risk group 5 (both parents affected)\r\n\r\n               1. > 50 years old or 10 years younger than the age of the youngest relative with\r\n                  pancreatic cancer, and< 80 years old\r\n\r\n               2. two parents affected by pancreatic cancer\r\n\r\n          6. Control 1 (Negative Controls):\r\n\r\n               1. are undergoing EUS and/or ERCP for non-pancreatic indications as part of their\r\n                  standard medical care, and\r\n\r\n               2. have no clinical or radiologic suspicion of pancreatic disease (chronic\r\n                  pancreatitis or pancreatic cancer)\r\n\r\n          7. Control 2 (Chronic Pancreatitis)\r\n\r\n               1. are undergoing EUS and/or ERCP for evaluation and/or treatment of suspected or\r\n                  proven chronic pancreatitis as part of their standard medical care, and,\r\n\r\n               2. have no clinical or radiologic suspicion of pancreatic cancer\r\n\r\n          8. Control 3 (Pancreatic Cancer)\r\n\r\n             a. are undergoing EUS and/or ERCP for evaluation and/or treatment of suspected or\r\n             proven pancreatic ductal adenocarcinoma (based on clinical and radiologic evidence)\r\n\r\n          9. Control 4 (Intraductal Papillary Mucinous Neoplasm or IPMN) a. are undergoing EUS\r\n             and/or ERCP for evaluation and/or treatment of suspected or proven pancreatic cancer\r\n             precursor, intraductal papillary mucinous neoplasm (based on clinical presentation and\r\n             radiologic or prior EUS or radiologic evidence of a dilated main pancreatic duct\r\n             and/or pancreatic cystic lesion communicating with the pancreatic ductal system)\r\n\r\n        Additional requirements for eligible high risk patients: i) All persons with known genetic\r\n        mutation must have proof of mutation status. Those who had research-related genetic testing\r\n        must have confirmation by a clinical CLIA-certified laboratory. ii) A good faith attempt\r\n        should be made to confirm pancreatic cancers in the family members via registration in a\r\n        pancreatic cancer registry iii) The affected first degree relative of the person being\r\n        screened must be confirmed by medical record or death certificate.\r\n\r\n        All control patients must be > 18 and < 80 years old and no personal or family history of\r\n        pancreatic cancer or a germline mutation linked to pancreatic cancer.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Patients will be excluded if they have any of the following:\r\n\r\n          1. medical comorbidities or coagulopathy that contraindicate endoscopy,\r\n\r\n          2. Karnosfky performance status of < 60,\r\n\r\n          3. had partial or complete resection of their pancreas\r\n\r\n          4. had a partial or complete gastrectomy with Billroth or Roux-en-Y anastomosis\r\n\r\n          5. a stricture or obstruction in the upper GI tract that does not allow passage of the\r\n             echoendoscope\r\n\r\n          6. life expectancy less than 5 years due to coexisting advanced cancer or AIDS.\r\n\r\n          7. inability to provide informed consent\r\n\r\n          8. pregnant patient\r\n\r\n          9. history of pancreatic cancer,\r\n\r\n         10. suspicion of pancreatic neoplasia based on clinical history (weight loss, unexplained\r\n             abdominal pain), physical examination (obstructive jaundice, cachexia), laboratory\r\n             tests (cholestastic liver function tests, markedly elevated CA19-9), and/or imaging\r\n             studies (pancreatic mass or cyst, dilated pancreatic and/or bile duct);\r\n\r\n         11. there is no interest in undergoing treatment of pancreatic neoplasm(s) detected by\r\n             screening.\r\n\r\n         12. history of chronic kidney disease, serum creatinine > 2.0 mg/dl or estimated\r\n             glomerulofiltration rate (eGFR) < 30 ml/min, ongoing acute renal failure, cirrhosis of\r\n             the liver, chronic hepatitis (The estimated glomerulfiltration rate (eGFR) will be\r\n             calculated based on age, race, and serum creatinine, using the on-line calculator at\r\n             nephron.com).\r\n\r\n         13. history of dementia\r\n      ","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","sponsor_type":"Other","conditions":"Early Pancreatic Neoplasia|Familial Pancreatic Neoplasia","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"This clinical study will assess the diagnostic yield of a clinical screening program for early pancreatic neoplasia in high risk individuals.","time_frame":"5 years"}]}
{"nct_id":"NCT00689728","start_date":"2008-06-30","phase":"Phase 2","enrollment":100,"brief_title":"A Study for Patients With Rheumatoid Arthritis on Methotrexate (MTX) With an Inadequate Response to TNF Inhibitor Therapy","official_title":"A Phase 2 Study of Multiple Intravenous Doses of LY2127399 in Patients With Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNF Inhibitor Therapy","primary_completion_date":"2010-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-05-31","last_update":"2018-12-06","description":"The purpose of this study is to explore whether LY2127399 is effective in relieving signs and symptoms of rheumatoid arthritis (RA) in patients with a history of inadequate response or intolerance to at least 1 Tumor Necrosis Factor-Alpha (TNF) inhibitor therapy. Examples of these TNF inhibitor therapies that are currently on the market include Enbrel (etanercept), Remicade (infliximab), and Humira (adalimumab).","other_id":"11351","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Have given written informed consent approval\r\n\r\n          -  Women must not be at risk to become pregnant during study participation\r\n\r\n          -  Diagnosis of Rheumatoid Arthritis\r\n\r\n          -  Active Rheumatoid Arthritis\r\n\r\n          -  Current, regular use of Methotrexate, at a stable dose\r\n\r\n          -  Have been on at least 1 biologic tumor necrosis factor-alpha (TNF) inhibitor therapy\r\n             and either failed or were intolerant to treatment\r\n\r\n          -  Other criteria to be reviewed by study doctor\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Use of excluded medications (reviewed by study doctor)\r\n\r\n          -  Have medical findings which, in the opinion of the study doctor, put patient at an\r\n             unacceptable risk for participation in the study\r\n\r\n          -  Have had recent or ongoing infection which, in the opinion of the study doctor put\r\n             patient at an unacceptable risk for participation\r\n\r\n          -  Evidence of tuberculosis\r\n\r\n          -  Have systemic inflammatory condition other than rheumatoid arthritis (RA), such as\r\n             juvenile RA, seronegative spondyloarthropathy, Crohn's disease, ulcerative colitis, or\r\n             psoriatic arthritis.\r\n\r\n          -  Other criteria to be reviewed by study doctor\r\n      ","sponsor":"Eli Lilly and Company","sponsor_type":"Industry","conditions":"Arthritis, Rheumatoid","interventions":[{"intervention_type":"Biological","name":"Biological: LY2127399","description":"LY2127399 will be administered as a single IV infusion over 30 minutes."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo will be administered as a single IV infusion over 30 minutes."}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of Participants Achieving American College of Rheumatology (ACR)50 Response at Week 16","time_frame":"16 weeks","description":"ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR50 Responder is defined as a participant with greater than 50% improvement from baseline in both tender and swollen joint counts and in at least 3 of the following 5 criteria: physician global assessment, patient global assessment, functional ability measure (Health Assessment Questionnaire-Disability Index which measures participants' perceived degree of difficulty when performing various daily activities), visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein."},{"outcome_type":"secondary","measure":"Number of Participants Experiencing An Adverse Event","time_frame":"Baseline up to 68 weeks","description":"Serious adverse events and other non-serious adverse events are located in the Reported Adverse Event section."},{"outcome_type":"secondary","measure":"Change From Baseline in Medical Outcome Study 36-Item Short Form Health Survey (SF-36) at Week 16","time_frame":"Baseline, 16 weeks","description":"Self-reported questionnaire of 36 questions in 8 domains (physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional, general health). Each domain is scored by summing individual items and transforming scores into a 0-100 scale (higher scores=better health status/function). The mental and physical component summaries are based on the 8 domains. Component scores are transformed scores representing a mean (50) and standard deviation (10) in the general United States (US) population. Scores > or <50 are above or below the average US population."},{"outcome_type":"secondary","measure":"Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response at Week 16","time_frame":"16 weeks","description":"ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. An ACR20 Responder is defined as a participant with at least 20% improvement from baseline in both tender and swollen joint counts and in at least 3 of the following 5 criteria: physician global assessment, patient global assessment, functional ability measure (Health Assessment Questionnaire-Disability Index which measures participants' perceived degree of difficulty when performing various daily activities), visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein."},{"outcome_type":"secondary","measure":"Percentage of Participants Achieving American College of Rheumatology (ACR)70 Response at Week 16","time_frame":"16 weeks","description":"ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. An ACR70 Responder is defined as a participant with at least 70% improvement from baseline in both tender and swollen joint counts and in at least 3 of the following 5 criteria: physician global assessment, patient global assessment, functional ability measure (Health Assessment Questionnaire-Disability Index which measures participants' perceived degree of difficulty when performing various daily activities), visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein."},{"outcome_type":"secondary","measure":"Change From Baseline in Tender Joint Count at Week 16","time_frame":"Baseline, 16 weeks","description":"The number of tender and painful joints is determined by examination of 28 joints (14 on each side) which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. The joints are assessed and classified as tender or not tender."},{"outcome_type":"secondary","measure":"Change From Baseline in Swollen Joint Count at Week 16","time_frame":"Baseline, 16 weeks","description":"The number of swollen joints is determined by examination of 28 joints (14 on each side) which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. The joints are assessed and classified as swollen or not swollen."},{"outcome_type":"secondary","measure":"Change From Baseline in Participant's Assessment of Joint Pain at Week 16","time_frame":"Baseline, 16 weeks","description":"Participant's assessment of joint pain using a visual analog scale (VAS), which ranged from 0 to 100 millimeters, where 0 indicated no pain and 100 indicated worst possible pain."},{"outcome_type":"secondary","measure":"Change From Baseline in Participant's Assessment of Disease Activity at Week 16","time_frame":"Baseline, 16 weeks","description":"Participant's assessment of their current arthritis disease activity using a visual analog scale (VAS), which ranged from 0 to 100 millimeters, where 0 indicated no arthritis activity and 100 indicated extremely active arthritis."},{"outcome_type":"secondary","measure":"Change From Baseline in Physician's Global Assessment of Disease Activity at Week 16","time_frame":"Baseline, 16 weeks","description":"Physician's global assessment of arthritis disease activity using a visual analog scale (VAS) which ranged from 0 to 100 millimeters, where 0 indicates no arthritis activity and 100 indicates extremely active arthritis."},{"outcome_type":"secondary","measure":"Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16","time_frame":"Baseline, 16 weeks","description":"The HAQ-DI questionnaire scores the participant's self-perception on the degree of difficulty when dressing and grooming, arising, eating, walking, hygiene, reach, grip, and performing other daily activities (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do). The scores for each of the functional areas, which have a range from 0 to 3, are averaged to calculate the functional disability index. Higher scores are associated with greater disability."},{"outcome_type":"secondary","measure":"Percent Change From Baseline in C-reactive Protein (CRP) at Week 16","time_frame":"Baseline, 16 weeks"},{"outcome_type":"secondary","measure":"Change From Baseline in Disease Activity Score (DAS28) at Week 16","time_frame":"Baseline, 16 weeks","description":"Disease Activity Score (modified to include the 28 joint count [DAS28]) consists of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP), and participant global assessment of their disease activity (patient global VAS). It is calculated by using the following formula:DAS28-CRP=0.56 times the square root of(28TJC)+0.28 times the square root of(28SJC)+0.36*natural log (ln)(CRP+1)+0.014*patient global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition."},{"outcome_type":"secondary","measure":"Number of Participants With Response (Response Rate) Based Upon European League Against Rheumatism Responder Index, 28 Joint Count (EULAR28) at Week 16","time_frame":"16 weeks","description":"EULAR28 categorizes clinical response based upon improvement since baseline in Disease Activity Score modified to include the 28 joint count (DAS28) and post-baseline DAS28. DAS28 consists of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP), and participant global assessment of their disease activity (patient global VAS). EULAR28 categories include: No Response (improvement in DAS28 of less than or equal to 0.6 units or post-baseline DAS28 score greater than 5.1 with improvement by less than or equal to 1.2 units), Moderate Response (post-baseline DAS28 score less than or equal to 5.1 with improvement by more than 0.6 units but no greater than 1.2 units or post-baseline DAS28 score greater than 3.2 with improvement by more than 1.2 units), and Good Response (post-baseline DAS28 score less than or equal to 3.2 with improvement by more than 1.2 units)."},{"outcome_type":"secondary","measure":"Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score at Week 16","time_frame":"Baseline, 16 weeks","description":"The FACIT Fatigue Score is a brief patient-reported measure of fatigue and consists of 13 items. Scores range from 0 to 52, with higher scores indicating less fatigue."},{"outcome_type":"secondary","measure":"Pharmacodynamics: Change From Baseline in Absolute CD20 + B Cell Count at Week 16","time_frame":"Baseline, 16 weeks","description":"B-lymphocyte antigen CD20 or CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B-cells. For this endpoint, total B cell counts (CD20+CD3- cells) are represented by number of cells per microliter. The reference range for the absolute counts is 43-602 cells per microliter."},{"outcome_type":"secondary","measure":"Pharmacodynamics: Change From Baseline in Total B Cells (CD20 + CD3-) as a Percentage of Total Lymphocytes","time_frame":"Baseline, 16 weeks","description":"B-lymphocyte antigen CD20 or CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B-cells. For this outcome, total B cells (CD20+CD3- cells) are expressed as the relative percent of lymphocytes. There is no reference range provided for this parameter by the performing laboratory."},{"outcome_type":"secondary","measure":"Pharmacodynamics: Change From Baseline in Serum Immunoglobulins at Week 16","time_frame":"Baseline, 16 weeks","description":"Serum immunoglobulin measured by Immunoglobulin A (IgA), Immunoglobulin G (IgG), and Immunoglobulin M (IgM) levels."},{"outcome_type":"secondary","measure":"Pharmacokinetics: Predicted Population Mean Parameter: C-trough Steady-state","time_frame":"Pre-dose, Day 1 through Week 24","description":"C-trough is defined as the concentration of LY at the end of the dosing interval at steady state. Mean C-trough value was obtained by conducting a simulation consisting of 1000 participants. The simulated data were then used to determine the noncompartmental PK parameters for each regimen. Mean and standard deviation of the Ctrough values were calculated for each dose group based on simulated data."},{"outcome_type":"secondary","measure":"Pharmacokinetics: Predicted Population Mean Parameter: T-half Life (t1/2, Tau)","time_frame":"Pre-dose, Day 1 through Week 24","description":"T-half life (t1/2, tau) is defined as the apparent steady state elimination within the dosing interval. T-half life was obtained by conducting a simulation consisting of 1000 participants using the study drug regimens (30 and 80 mg, intravenous infusion over 30 minutes, once every 3 weeks). The simulated data were then used to determine the noncompartmental PK parameters for each regimen. Mean and standard deviation of the t-half life values were calculated for each dose group based on simulated data."}]}
{"nct_id":"NCT00656357","start_date":"2008-06-30","phase":"Phase 1/Phase 2","enrollment":20,"brief_title":"Study of Safety and Potential Efficacy of SYN117 in Cocaine Dependent Volunteers","official_title":"A Human Laboratory Assessment of the Safety and Potential Efficacy of SYN117 (Nepicastat) in Cocaine-dependent Volunteers Receiving Cocaine","primary_completion_date":"2009-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-05-31","last_update":"2018-08-17","description":"This study will assess the potential interaction and subjective effects between intravenous cocaine and SYN117 in non-treatment seeking cocaine dependant subjects","other_id":"SYN117-CL01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  non treatment seeking cocaine dependent\r\n\r\n          -  English speaking\r\n\r\n          -  meet DSM IV TR criteria for cocaine dependence\r\n\r\n          -  pulse 50-90bpm\r\n\r\n          -  systolic BP 85-140 mmHg\r\n\r\n          -  diastolic BP 45-90 mmHg\r\n\r\n          -  essentially normal liver and kidney function blood tests\r\n\r\n          -  ECG normal\r\n\r\n          -  sign informed consent\r\n\r\n          -  negative urine pregnancy test at screening and admission\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  history or evidence of seizure disorder or brain injury\r\n\r\n          -  previous medically adverse reaction to cocaine, including loss of consciousness, chest\r\n             pain or epileptic seizure\r\n\r\n          -  neurological disorders, organic brain disease, dementia\r\n\r\n          -  psychiatric disorders such as psychosis, schizophrenia, bipolar disorder, major\r\n             depression\r\n\r\n          -  history of suicide attempts within past 3 months or suicidal ideation/plan\r\n\r\n          -  history of clinically significant heart disease or hypertension\r\n\r\n          -  family history in 1st degree relatives of early cardiovascular morbidity or mortality\r\n\r\n          -  untreated or unstable medical conditions\r\n\r\n          -  positive HIV test\r\n\r\n          -  pregnant or nursing\r\n\r\n          -  have asthma or are currently using alpha, beta agonists or theophylline or other\r\n             sympathomimetics\r\n\r\n          -  test positive for other drugs of abuse with the exception of cocaine, cocaine\r\n             metabolites or marijuana\r\n\r\n          -  any other illness, condition or use of psychotropic medications which preclude\r\n             safe/successful completion of the study\r\n\r\n          -  currently on parole\r\n      ","sponsor":"Biotie Therapies Inc.","sponsor_type":"Industry","conditions":"Cocaine Dependence","interventions":[{"intervention_type":"Drug","name":"Drug: SYN117 Placebo","description":"Placebo"},{"intervention_type":"Drug","name":"Drug: SYN117 80 mg","description":"SYN117 80 mg"},{"intervention_type":"Drug","name":"Drug: SYN117 160 mg","description":"SYN117 160 mg"},{"intervention_type":"Drug","name":"Drug: Cocaine 10mg","description":"IV Cocaine 10mg"},{"intervention_type":"Drug","name":"Drug: Cocaine 20mg","description":"IV Cocaine 20mg"},{"intervention_type":"Drug","name":"Drug: Cocaine 40mg","description":"IV Cocaine 40mg"},{"intervention_type":"Drug","name":"Drug: Saline","description":"IV Cocaine Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"Determine the safety of treatment with SYN117 in cocaine-dependent volunteers by measuring hemodynamic and subjective effects of administration of ascending doses of cocaine(10mg, 20mg, 40mg)and placebo during treatment with ascending doses of SYN117.","time_frame":"inpatient 14 days with 2 week outpatient follow-up"},{"outcome_type":"secondary","measure":"Determine tolerability by measuring adverse events","time_frame":"inpatient 14 days, 2 weeks post followup visit"},{"outcome_type":"secondary","measure":"Determine subjective effects produced by self administration of cocaine or placebo","time_frame":"Days 4, 8, 12 and 13"},{"outcome_type":"secondary","measure":"Determine the effect of SYN117 of the pharmacokinetics of IV cocaine","time_frame":"Days 3 and 11"},{"outcome_type":"secondary","measure":"Determine if any baseline measures of impulsivity or drug use severity predict efficacy of SYN117 in reducing subjective effects of cocaine","time_frame":"Days 4, 8 and 12"}]}
{"nct_id":"NCT00726661","start_date":"2008-06-30","enrollment":1287,"brief_title":"An Observational Study of Treatment Patterns and Safety Outcomes for Metastatic or Locally Recurrent Breast Cancer (VIRGO)","official_title":"An Observational Study of Treatment Patterns and Safety Outcomes for Metastatic or Locally Recurrent Breast Cancer","primary_completion_date":"2012-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2012-12-31","last_update":"2017-07-11","description":"This is a multicenter, prospective observational cohort study (OCS) designed to follow patients with locally recurrent or metastatic breast cancer in the United States. Two cohorts will be included: - Patients with human epidermal growth factor receptor 2-negative (HER2-negative) disease receiving their first cytotoxic chemotherapy and/or targeted therapy (approximately 825 patients) - Patients with hormone receptor-positive (HR-positive) disease receiving their first hormonal therapy for advanced disease (approximately 425 patients) Patients who have received any chemotherapy for advanced disease more than 8 weeks prior to enrollment to this OCS will not be eligible. A total of approximately 1,250 patients will be enrolled. Approximately 150 study sites will be activated in order to achieve complete enrollment by December 2010.","other_id":"AVF4349n","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","population":"Breast cancer clinic","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Signed Informed Consent Form\r\n\r\n          -  Locally recurrent or metastatic breast cancer\r\n\r\n          -  Receipt of first systemic cytotoxic chemotherapy and/or targeted therapy among those\r\n             with HER2-negative disease or first hormone therapy among those with HR-positive\r\n             disease for the treatment of locally recurrent or metastatic disease, within 8 weeks\r\n             prior to enrollment\r\n\r\n        Exclusion Criteria\r\n\r\n          -  Any medical condition, including mental illness or substance abuse, deemed by the\r\n             investigator to be likely to interfere with a patient's ability to provide informed\r\n             consent or comply with the treatment\r\n\r\n          -  Any prior chemotherapy started more than 8 weeks prior to enrollment for the treatment\r\n             of locally recurrent or for metastatic breast cancer\r\n\r\n          -  Concurrent participation only in a blinded clinical trial\r\n      ","sponsor":"Genentech, Inc.","sponsor_type":"Industry","conditions":"Breast Cancer","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Progression Free Survival","time_frame":"Approximately 4.5 years","description":"Progression free survival was defined as the time from enrollment to progression or death of any cause, whichever came first. The disease response status was assessed by the investigator according to the method of his or her choice. The choices included computed tomography (CT) scan, magnetic resonance imaging (MRI), bone scan, X-ray, Positron emission tomography (PET) or CT PET, physical exam, laboratory exam, and other method."},{"outcome_type":"secondary","measure":"Overall Survival","time_frame":"Approximately 4.5 years","description":"Overall survival was defined as the time from enrolment to death of any cause."},{"outcome_type":"secondary","measure":"Number of Participants With Tumor Response","time_frame":"Approximately 4.5 years","description":"The tumor response was measured as complete response, partial response, stable disease, progressive disease, or clinical deterioration based on their best overall response. The tumor response was assessed by the investigator according to the method of his or her choice. The choices included computed tomography (CT) scan, magnetic resonance imaging (MRI), bone scan, X-ray, Positron emission tomography (PET) or CT PET, physical exam, laboratory exam, and other method."},{"outcome_type":"secondary","measure":"Number of Hormone Receptor-positive Participants Who Initiated Cytotoxic Chemotherapy Following Discontinuation","time_frame":"Approximately 4.5 years","description":"Participants were assessed quarterly for progressive events and treatment status."},{"outcome_type":"secondary","measure":"Number of Participants With Any Adverse Events, Any Serious Adverse Events, Any AEs Leading to Early Treatment Discontinuation, and Adverse Events Leading to Hospitalization or Death","time_frame":"Approximately 4.5 years","description":"An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect."},{"outcome_type":"secondary","measure":"Number of Participants With Arterial Thromboembolic Events, Venous Thromboembolic Events, Left Ventricular Systolic Dysfunction, and Peripheral Neuropathy","time_frame":"Approximately 4.5 years","description":"All AEs were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3 as Grade 1 (mild), Graded 2 (moderate), Grade 3 (severe), Grade 4 (very severe, life threatening, or disabling), and Grade 5 (death related to AE). Venous Thromboembolic Events (VTEs) included all Grade 4 or of more severity of deep vein thrombosis, pulmonary embolus; Arterial Thromboembolic Events (ATEs) Included new or worsening angina pectoris, myocardial infarction, stroke, transient ischemic attack, peripheral arterial ischemia of any NCI CTCAE grade; Left Ventricular Systolic Dysfunction (LVSD) included congestive heart failure) of NCI CTCAE Grade 2 or of more severity; Peripheral Neuropathy (PN) included sensory and/or motor events of Grade 3 or of more severity."}]}
{"nct_id":"NCT00658398","start_date":"2008-05-31","phase":"Phase 3","enrollment":601,"brief_title":"The BREVALCO Study, Effect of an Interactive Computer Program to Prevent Alcohol Misuse","official_title":"Effect of an Interactive Computer Program to Prevent Alcohol Misuse. A Multicentre Randomized Controlled Trial. The BREVALCO Study.","primary_completion_date":"2012-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-04-30","last_update":"2015-05-20","description":"The purpose of this study is to evaluate the effect of a brief computer program to prevent alcohol misuse for patients consulting in an emergency department and screened for alcohol misuse.","other_id":"P060252","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  age >=18\r\n\r\n          -  patients consulting in an emergency department\r\n\r\n          -  screened for alcohol misuse or dependence (i.e. for women: AUDIT score>5 or\r\n             consumption of more than 14 alcohol drinks per week For men: AUDIT score>8 or\r\n             consumption of more than 7 alcohol drinks per week)\r\n\r\n          -  informed and signed consent form\r\n\r\n          -  clinical exam performed\r\n\r\n          -  having social protection\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  vital risk\r\n\r\n          -  patients having mental disorder,\r\n\r\n          -  patient unable to answer the questions and to participate in the computer program\r\n             because of their clinical condition\r\n\r\n          -  patients no understanding French languages\r\n\r\n          -  patient already being treated for alcohol disorder\r\n\r\n          -  patients asking for a specific treatment for their alcohol disorder\r\n\r\n          -  patients unable to answer to the follow-up visits\r\n      ","sponsor":"Assistance Publique - Hpitaux de Paris","sponsor_type":"Other","conditions":"AOD Misuse","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Interactive Computer Program to prevent alcohol misuse.","description":"Interactive Computer Program with questionnaires, video and informations"}],"outcomes":[{"outcome_type":"primary","measure":"The mean number of alcohol drinks by day in the previous week, at 12months.","time_frame":"12 months"},{"outcome_type":"secondary","measure":"the AUDIT score (0-40) at 12 months,","time_frame":"12 months"},{"outcome_type":"secondary","measure":"the DSM-IV-TR criteria of alcohol abuse or dependence at 12 months","time_frame":"12 months"},{"outcome_type":"secondary","measure":"the mean number of drunkenness or alcohol intoxications with behaviour problems per day in the previous week at 12 months,","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Three numerical scales of social satisfaction (0 to 10) based on health, family life or relationship, occupation or daily activity at 12 months,","time_frame":"12 months"},{"outcome_type":"secondary","measure":"the percentage of consultations at an ED at 12 months,","time_frame":"12 months"},{"outcome_type":"secondary","measure":"the percentage of consultations at hospital at 12 months,","time_frame":"12 months"},{"outcome_type":"secondary","measure":"the rate of acceptance of a long-term follow-up","time_frame":"12 months"},{"outcome_type":"secondary","measure":"the rate of suicide attempts.","time_frame":"12 months"}]}
{"nct_id":"NCT00666757","start_date":"2008-05-31","phase":"Phase 4","enrollment":750,"brief_title":"A Study Comparing Duloxetine to Other Antidepressants in the Treatment of Severe Depression","official_title":"TRY FIRST: A 12-Week, Randomized, Open-Label Trial of Duloxetine Versus Generic SSRIs in the Treatment of a Severe Depressive Episode","primary_completion_date":"2009-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-03-31","last_update":"2010-06-15","description":"The purpose of this study is to compare duloxetine with other antidepressants in the treatment of severe depression.","other_id":"11715","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion criteria:\r\n\r\n          -  At least 18 years of age\r\n\r\n          -  Have major depression and are currently in a severe depressive episode\r\n\r\n          -  Have a degree of understanding such that patient can communicate with the investigator\r\n             and study staff\r\n\r\n          -  All females must test negative for pregnancy\r\n\r\n          -  Females of childbearing potential must use reliable method of birth control during the\r\n             study and for 1 month after taking the last dose of study drug\r\n\r\n        Exclusion criteria:\r\n\r\n          -  Have not responded to duloxetine for depression in the past\r\n\r\n          -  Have a history of bipolar disorder, a psychotic disorder (such as schizophrenia), a\r\n             cognitive disorder (such as moderate or severe dementia), or obsessive-compulsive\r\n             disorder (OCD)\r\n\r\n          -  Are at significant risk for suicide\r\n\r\n          -  Have not responded to 2 or more adequate trials of antidepressant medications during\r\n             the current depressive episode\r\n\r\n          -  Have a serious, unstable medical condition\r\n\r\n          -  Have a current or recent history of substance abuse or dependence\r\n\r\n          -  Have had electroconvulsive therapy (ECT), transcranial magnetic stimulation (rTMS), or\r\n             vagus nerve stimulation (VNS) in the past year\r\n\r\n          -  Have started psychotherapy within 6 weeks prior to study entry\r\n\r\n          -  Have a serious medical illness or clinically significant laboratory abnormality that\r\n             is not stabilized or is anticipated, in the judgment of the investigator, to require\r\n             hospitalization or use of an excluded medication during the course of the study\r\n      ","sponsor":"Eli Lilly and Company","sponsor_type":"Industry","conditions":"Depression","interventions":[{"intervention_type":"Drug","name":"Drug: duloxetine","description":"30-120 milligrams (mgs) orally daily for 12 weeks"},{"intervention_type":"Drug","name":"Drug: fluoxetine","description":"20-80 mgs orally daily for 12 weeks"},{"intervention_type":"Drug","name":"Drug: citalopram","description":"20-40 mgs orally daily for 12 weeks"},{"intervention_type":"Drug","name":"Drug: paroxetine","description":"20-50 mgs orally daily for 12 weeks"},{"intervention_type":"Drug","name":"Drug: sertraline","description":"50-200 mgs orally daily for 12 weeks"}],"outcomes":[{"outcome_type":"secondary","measure":"Change From Baseline in Diastolic Blood Pressure at Week-12 Endpoint","time_frame":"Baseline, 12 Weeks","description":"Mean change from baseline to endpoint in diastolic blood pressure"},{"outcome_type":"secondary","measure":"Change From Baseline in Pulse Rate at Week-12 Endpoint","time_frame":"Baseline, 12 Weeks","description":"Mean change from baseline to endpoint in pulse rate"},{"outcome_type":"secondary","measure":"Change From Baseline in Weight at Week-12 Endpoint","time_frame":"Baseline, 12 Weeks","description":"Mean change from baseline to endpoint in weight"},{"outcome_type":"primary","measure":"Probability of Remission [16-item Quick Inventory of Depressive Symptomatology (QIDS-SR) Score Less Than or Equal to 5 at 12-Week Endpoint]","time_frame":"12 weeks","description":"Visitwise probability of participants per treatment meeting remission criteria (QIDS-SR total score [TS]<\/=5 at week 12 endpoint) were estimated using a pseudolikelihood-based mixed-models repeated measures analysis for a categorical outcome, model included fixed, categorical effects of treatment group (duloxetine vs. SSRIs), visit, treatment group-by-visit & continuous, fixed covariate of baseline QIDS-SR TS, and random effect of participant. Primary analysis contrasted remission probability at week 12 endpoint between treatment groups."},{"outcome_type":"secondary","measure":"Change From Baseline in QIDS-SR Total Score at 12-Week Endpoint (Mood Measure)","time_frame":"Baseline, 12 weeks","description":"The QIDS-SR is a 16-item, participant-rated short form of the Inventory of Depressive Symptomatology that assesses 9 domains: sad mood, concentration, self-outlook, suicidal ideation, involvement, energy/fatigability, sleep disturbance, appetite/weight increase/decrease and psychomotor agitation/retardation. Scores range from 0 (none) to 27 (very severe). The QIDS-SR total score was used to derive the mean change from baseline to endpoint depression."},{"outcome_type":"secondary","measure":"Probability of Remission [17-item Hamilton Depression Rating Scale (HAMD-17) (Mood Measure) Less Than or Equal to 7 at 12-Week Endpoint]","time_frame":"12 weeks","description":"Visitwise percentages of participants meeting remission criteria HAMD-17 total score [TS] <\/=7 at week 12 endpoint) were estimated using a categorical, pseudolike-lihood-based repeated measures approach, & included fixed, categorical effects of treatment group (duloxetine vs. SSRIs), visit, treatment group-by-visit interaction, & continuous, fixed covariate of baseline HAMD-17 TS. Primary analysis will be contrast of remission rates at week 12 endpoint between treatment groups, & represents estimated remission rates for each treatment group had all participants completed 12 weeks of therapy."},{"outcome_type":"secondary","measure":"Probability of Response [QIDS-SR Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint]","time_frame":"Baseline, 12-Weeks","description":"Visitwise percentages of participants meeting response criteria (50% reduction from baseline QIDS-SR total score at 12-week endpoint) were estimated using a categorical, pseudolikelihood-based repeated measures approach, & included fixed, categorical effects of treatment group, visit, treatment group-by-visit interaction, & continuous, fixed covariate of baseline QIDS-SR. The primary analysis will be the contrast of response rates at week 12 endpoint between treatment groups, and represents estimated response rates for each treatment group had all participants completed 12 weeks of therapy."},{"outcome_type":"secondary","measure":"Probability of Response [HAMD-17 Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint]","time_frame":"Baseline, 12-Weeks","description":"Visitwise percentages of participants meeting response criteria 50% reduction from baseline in HAMD-17 total score at 12-Week endpoint) were estimated using a categorical, pseudolike-lihood-based repeated measures approach, & included fixed, categorical effects of treatment group, visit, treatment group-by-visit interaction, & continuous, fixed covariate of baseline HAMD-17 TS. Primary analysis will be the contrast of response rates at week 12 endpoint between treatment groups, & represents estimated response rates for each treatment group had all participants completed 12 weeks of therapy."},{"outcome_type":"secondary","measure":"Change From Baseline in HAMD-17 Total Score at 12-Week Endpoint (Mood Measure)","time_frame":"Baseline, 12 Weeks","description":"The HAMD-17 is a rater-administered assessment of depression severity and improvement, with total score ranges from 0 (not at all depressed) to 52 (most severely depressed)."},{"outcome_type":"secondary","measure":"Change From Baseline in HAMD-17 Anxiety/Somatization Subscale Score at 12-Week Endpoint (Mood Measure)","time_frame":"Baseline, 12 Weeks","description":"HAMD-17 subscale consists of items 10, 11, 12, 13, 15, and 17 evaluates agitation, and severity of psychic and somatic manifestations of anxiety. Total subscale scores range from 0 (normal) to 18 (severe). Mean change from baseline to endpoint."},{"outcome_type":"secondary","measure":"Change From Baseline in HAMD-17 Maier Subscale Score at 12-Week Endpoint (Mood Measure)","time_frame":"Baseline, 12 weeks","description":"HAMD-17 Maier Subscale consists of Items 1, 2, 7, 8, 9, 10 and represents the \"core\" symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe)."},{"outcome_type":"secondary","measure":"Change From Baseline in HAMD-17 Bech Subscale Score at 12-Week Endpoint (Mood Measure)","time_frame":"Baseline, 12 Weeks","description":"HAMD-17 Bech subscale consists of items 1, 2, 7, 8, 10, and 13 used to evaluate core symptoms of Major Depressive Disorder (MDD). Total subscale scores range from 0 (normal) to 22 (severe)."},{"outcome_type":"secondary","measure":"Change From Baseline in HAMD-17 Retardation Subscale Score at 12-Week Endpoint (Mood Measure)","time_frame":"Baseline, 12 Weeks","description":"The HAMD-17 Retardation subscale consists of Items 1, 7, 8, 14 and evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation. Total subscale scores range from 0 (normal) to 14 (severe)."},{"outcome_type":"secondary","measure":"Change From Baseline in HAMD-17 Sleep Subscale Score at 12-Week Endpoint (Mood Measure)","time_frame":"Baseline, 12 Weeks","description":"The HAMD-17 Sleep Subscale consists of Items 4, 5, 6 and evaluates initial, middle, and late insomnia. Total subscale scores range from 0 (no difficulty) to 6 (difficulty)."},{"outcome_type":"secondary","measure":"Change From Baseline in Brief Pain Inventory (BPI) Average 24-hour Pain Score, in Particpants With a Baseline BPI Average 24-hour Pain Score of 3 or Greater, at 12-Week Endpoint (Pain Measure)","time_frame":"Baseline, 12 Weeks","description":"The BPI is a self-reported scale measuring pain severity and pain-specific interference on function on a scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The BPI average 24-hour pain measure was used to derive the overall mean change from baseline to endpoint, in those participants who had a BPI average 24-hour pain score of 3 or greater at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in BPI Average 24 Hour Pain Score at 12-Week Endpoint (Pain Measure)","time_frame":"Baseline, 12 weeks","description":"The BPI is a self-reported scale measuring pain severity and pain-specific interference on function, with scores ranging from 0 (does not interfere) to 10 (completely interferes). The BPI average 24-hour pain measure was used to derive the overall mean change from baseline to endpoint."},{"outcome_type":"secondary","measure":"Change From Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score at 12-Week Endpoint (Functional Outcome Measure)","time_frame":"Baseline, 12 weeks","description":"The SDS is a participant-rated anchored visual analog scale to assess disability across the three domains of work/school, social life, and family life, with each item scored from 0 (not at all) to 10 (very severely), with a summarization of the 3 items to evaluate global functioning. The Global Functional Impairment Score is a total score score that ranges from 0 (unimpaired) to 30 (highly impaired), and was used to derived the mean change from baseline to endpoint."},{"outcome_type":"secondary","measure":"Change From Baseline in SDS Work/School Item Score at 12-Week Endpoint (Functional Outcome Measure)","time_frame":"Baseline, 12 Weeks","description":"The SDS is completed by the participant and Item 1 is used to assess the effect of the participant's symptoms on their work/school schedule. Scores range from 0 to 10 with higher values indicating greater disruption in the participant's work/school life."},{"outcome_type":"secondary","measure":"Change From Baseline in Sheehan Disability Scale (SDS) Family/Home Item Score at Week-12 Endpoint (Functional Outcome Measure)","time_frame":"Baseline, 12 Weeks","description":"The SDS is completed by the participant and Item 3 is used to assess the effect of the participant's symptoms on their family life/home responsibilities. Scores range from 0 to 10 with higher values indicating greater disruption in the participant's family life/home responsibilities."},{"outcome_type":"secondary","measure":"Change From Baseline in SDS Social Item Score at 12-Week Endpoint (Functional Outcome Measure)","time_frame":"Baseline, 12 Weeks","description":"The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life."},{"outcome_type":"secondary","measure":"Change From Baseline in Systolic Blood Pressure at Week-12 Endpoint","time_frame":"Baseline, 12 Weeks","description":"Mean change from baseline to endpoint in systolic blood pressure"},{"outcome_type":"other","measure":"Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Dollars of Income Lost Due to Work Presenteeism (WP)Score, at Week-12 Endpoint","time_frame":"Baseline, 12 Weeks","description":"WP score was calculated by taking midpoint of annual before-tax income reported on HPQ. A multiplier of 1.25 produced estimated direct & indirect (i.e. benefits) income. Annual hours expected to work were calculated from expected daily work hours, multiplied by 236 days. Hourly, indirect income was total direct + indirect income, divided by # of expected annual work hours. Indirect hours lost annually for WP=hours expected to be worked annually times WP percent, times hourly rate=dollars earned, and then subtracted from total direct + indirect income=dollars lost annually due to WP."},{"outcome_type":"other","measure":"Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Dollars of Income Lost Due to Work Absenteeism Score at Week-12 Endpoint","time_frame":"Baseline, 12 weeks","description":"Self-administered assessment used to determine a participant's work performance in terms of employment status, absenteeism if employed, productivity while at work, usual occupation, and annual income. Tool assesses the potential impact of change in depressive symptoms on work productivity and its associated employer costs. Scale ranges from 0 to 100% of work days in past 30 days. Absenteeism and presenteeism were combined into a measure of total lost work performance by adding absenteeism to the value ([100-absenteeism] × [100-presenteeism]). Mean change baseline to endpoint."},{"outcome_type":"other","measure":"Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Absenteeism at 12-Week Endpoint","time_frame":"Baseline, 12 Weeks","description":"Self-administered assessment used to determine a subject's work performance in terms of employment status, absenteeism if employed, productivity while at work, usual occupation, and annual income. Tool assesses the potential impact of change in depressive symptoms on work productivity and its associated employer costs. Defined on a 0-100 scale for the percentage of work days the respondent missed in the past 30 days. Absolute absenteeism: actual hours worked minus expected hours equals number of missed work days. Mean change baseline to endpoint is reported."},{"outcome_type":"other","measure":"Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Presenteeism Score, at Week-12 Endpoint","time_frame":"Baseline, 12 Weeks","description":"Self-administered assessment used to determine a participant's work performance (employment status, absenteeism if employed, productivity while at work, usual occupation, & annual income). Tool assesses the potential impact of change in depressive symptoms on work productivity & its associated employer costs using a 0-100 scale in which 0 meant doing no work at all on days spent at work and 100 meant performing at the level of a top worker. Absolute presenteeism: difference between \"score for self\" and \"score for average worker in same job\". Mean change baseline to endpoint is reported."}]}
{"nct_id":"NCT00691015","start_date":"2008-05-31","phase":"Phase 2","enrollment":48,"brief_title":"Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer Who Are Undergoing Donor Stem Cell Transplant","official_title":"A Phase II Study of Sirolimus, Tacrolimus and Thymoglobulin, as Graft-versus-Host- Disease Prophylaxis in Patients Undergoing Unrelated Donor Hematopoietic Cell Transplantation","primary_completion_date":"2014-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-04-30","last_update":"2017-06-28","description":"RATIONALE: Giving low doses of chemotherapy, monoclonal antibodies, and radiation therapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus, sirolimus, and antithymocyte globulin before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying the side effects of giving sirolimus together with tacrolimus and antithymocyte globulin and to see how well it works in preventing graft-versus-host disease in patients with hematologic cancer who are undergoing donor stem cell transplant.","other_id":"2007-127","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        DISEASE CHARACTERISTICS:\r\n\r\n          -  Diagnosis of a hematological malignancy, including any of the following:\r\n\r\n               -  Non-Hodgkin lymphoma in complete remission (CR) or partial remission (PR)\r\n\r\n               -  Hodgkin lymphoma in CR or PR\r\n\r\n               -  Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) meeting either\r\n                  of the following criteria:\r\n\r\n                    -  In CR\r\n\r\n                    -  Not in CR and meets the following criteria:\r\n\r\n                         -  Bone marrow blast < 20% within 4 weeks of transplantation\r\n\r\n                         -  Peripheral blood absolute blast count < 500 per microliter on the day\r\n                            of initiating conditioning therapy\r\n\r\n               -  Myelodysplastic syndromes, treated or untreated\r\n\r\n               -  Chronic myeloid leukemia in chronic phase or accelerated phase\r\n\r\n               -  Multiple myeloma in CR or PR\r\n\r\n               -  Chronic lymphocytic leukemia in second or greater CR or PR\r\n\r\n               -  Myelofibrosis or other myeloproliferative disorders meeting the following\r\n                  criteria:\r\n\r\n                    -  Bone marrow blasts < 20% within 4 weeks of transplantation\r\n\r\n                    -  Peripheral blood absolute blast count < 500 per microliter on the day of\r\n                       initiating conditioning therapy\r\n\r\n                    -  Patients with ascites not allowed\r\n\r\n          -  No prior bone marrow or ex vivo engineered or processed graft (i.e., CD34+ enrichment,\r\n             T-cell depletion, etc)\r\n\r\n          -  Scheduled to undergo peripheral blood stem cell transplantation from a suitable\r\n             HLA-matched or -mismatched unrelated donor, as determined by treating physician\r\n\r\n               -  High resolution molecular HLA typing is required for HLA class I and II\r\n\r\n               -  No more than one antigen or allele mismatch\r\n\r\n          -  No documented uncontrolled CNS disease\r\n\r\n        PATIENT CHARACTERISTICS:\r\n\r\n          -  ECOG performance status (PS) 0-2\r\n\r\n          -  Karnofsky PS 60-100%\r\n\r\n          -  Creatinine clearance > 50 mL/min\r\n\r\n          -  Bilirubin < 3 times upper limit of normal (ULN)\r\n\r\n          -  ALT and AST < 3 times ULN\r\n\r\n          -  LVEF > 50%\r\n\r\n          -  FVC, FEV_1, or DLCO > 50% predicted\r\n\r\n               -  Patients on home oxygen not allowed\r\n\r\n          -  Able to cooperate with oral medication intake\r\n\r\n          -  HIV negative\r\n\r\n          -  No active hepatitis B or hepatitis C\r\n\r\n          -  No known contraindication to sirolimus, tacrolimus, or anti-thymocyte globulin\r\n\r\n        PRIOR CONCURRENT THERAPY:\r\n\r\n          -  See Disease Characteristics\r\n      ","sponsor":"Barbara Ann Karmanos Cancer Institute","sponsor_type":"Other","conditions":"Chronic Myeloproliferative Disorders|Leukemia|Lymphoma|Multiple Myeloma and Plasma Cell Neoplasm|Myelodysplastic Syndromes|Myelodysplastic/Myeloproliferative Neoplasms","interventions":[{"intervention_type":"Drug","name":"Drug: carmustine","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: cyclophosphamide","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: cytarabine","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: etoposide","description":"Given IV"},{"intervention_type":"Biological","name":"Biological: rituximab","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: busulfan","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: fludarabine phosphate","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: melphalan","description":"Given IV"},{"intervention_type":"Radiation","name":"Radiation: total body irradiation (TBI)","description":"Given once or twice daily"},{"intervention_type":"Drug","name":"Drug: anti-thymocyte globulin IV","description":"Given IV"}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of Acute Graft-versus-host Disease (GVHD)","time_frame":"Within 100 days after donor peripheral blood stem cell transplantation (PBSCT) as assessed by Glucksberg criteria"},{"outcome_type":"primary","measure":"Severity of Acute Graft-versus-host Disease (GVHD)","time_frame":"Within 100 days after donor peripheral blood stem cell transplantation (PBSCT) as assessed by Glucksberg criteria"},{"outcome_type":"primary","measure":"Safety, as Defined by Serious Adverse Events and Adverse Events Related to Study Treatment.","time_frame":"Within 6 months after PBSCT"},{"outcome_type":"secondary","measure":"Incidence of Chronic GVHD.","time_frame":"Within 2 years after PBSCT"},{"outcome_type":"secondary","measure":"Time to Engraftment (i.e., Absolute Neutrophil Recovery [ANC > 500/mm³] )","time_frame":"post transplant, up to 4 weeks"},{"outcome_type":"secondary","measure":"Overall Survival.","time_frame":"At 2 years after PBSCT"},{"outcome_type":"secondary","measure":"Incidence of Infections, Including Bacterial, Fungal, and Viral Infections (i.e., CMV and EBV Reactivation, Including Post-transplant Lymphoproliferative Disorders)","time_frame":"Within 6 months after PBSCT"},{"outcome_type":"secondary","measure":"Karnofsky Performance Status Performance Status","time_frame":"At 90 days after PBSCT","description":"100 - Normal; no complaints; no evidence of disease. 90 - Able to carry on normal activity; minor signs or symptoms of disease. 80 - Normal activity with effort; some signs or symptoms of disease. 70 - Cares for self; unable to carry on normal activity or to do active work. 60 - Requires occasional assistance, but is able to care for most of their personal needs.\r\n50 - Requires considerable assistance and frequent medical care. 40 - Disabled; requires special care and assistance. 30 - Severely disabled; hospital admission is indicated although death not imminent.\r\n20 - Very sick; hospital admission necessary; active supportive treatment necessary.\r\n10 - Moribund; fatal processes progressing rapidly. 0 - Dead"}]}
{"nct_id":"NCT00677287","start_date":"2008-05-31","phase":"Phase 1/Phase 2","enrollment":14,"brief_title":"Histocompatibility Leukocyte Antigen (HLA)-A*2402 Restricted Peptide Vaccine Therapy in Patients With Colorectal Cancer","official_title":"Phase I/II Study of Multiple-Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*2402 in Combination With Tegafur/Uracil/Folinate in Treating Patients With Refractory Colorectal Cancer","primary_completion_date":"2009-03-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2009-03-31","last_update":"2009-12-29","description":"The purpose of this study is to evaluate the safety and time to progression of HLA-A*2402 restricted epitope peptides RNF43, TOMM34, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in combination with Tegafur/Uracil/Folinate chemotherapy.","other_id":"CRC-A24-I, II","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Advanced or recurrent colorectal cancer\r\n\r\n          -  Resistant against chemotherapy including CPT-11, l-OHP+/- 5-FU +/- bevacizumab or\r\n             difficult to continue the chemotherapy due to intolerable side effect(s)\r\n\r\n          -  ECOG performance status 0-2\r\n\r\n          -  Life expectancy > 3 months\r\n\r\n          -  HLA-A*2402\r\n\r\n          -  Laboratory values as follows\r\n\r\n               -  2000/mm3<WBC<15000/mm3\r\n\r\n               -  Platelet count>100000/mm3\r\n\r\n               -  Bilirubin < 3.0mg/dl\r\n\r\n               -  Asparate transaminase < 150IU/L\r\n\r\n               -  Alanine transaminase < 150IU/L\r\n\r\n               -  Creatinine < 3.0mg/dl\r\n\r\n          -  Able to receive oral Tegafur/Uracil/Folinate therapy\r\n\r\n          -  Able and willing to give valid written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnancy(woman of childbearing potential:Refusal or inability to use effective means\r\n             of contraception)\r\n\r\n          -  Breastfeeding\r\n\r\n          -  Active or uncontrolled infection\r\n\r\n          -  Unhealed external wound\r\n\r\n          -  Concurrent treatment with steroids or immunosuppressing agent\r\n\r\n          -  Prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks\r\n\r\n          -  Uncontrolled brain and/or intraspinal lesion(s)\r\n\r\n          -  History of allergy to Tegafur, Uracil, and/or Folinate\r\n\r\n          -  Decision of unsuitableness by principal investigator or physician-in-charge\r\n      ","sponsor":"Tokyo University","sponsor_type":"Other","conditions":"Colorectal Cancer|Colon Cancer|Rectal Cancer","interventions":[{"intervention_type":"Biological","name":"Biological: RNF43, TOMM34, VEGFR1 and VEGFR2","description":"Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, RNF43 peptide (1mg), TOMM34 peptide (1mg), VEGFR1 peptide (1mg) and VEGFR2 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection in combination with Tegafur/Uracil/Folinate chemotherapy."}],"outcomes":[{"outcome_type":"primary","measure":"safety(Phase I:toxicities as assessed by NCI CTCAE version3) and efficacy(Phase II:Feasibility as evaluated by RECIST)","time_frame":"2 months"},{"outcome_type":"secondary","measure":"To evaluate immunological responses","time_frame":"2 months"}]}
{"nct_id":"NCT01489930","start_date":"2008-05-31","phase":"N/A","enrollment":67,"brief_title":"Effects of Resistance and Endurance Training on Synthesis of Individual Muscle Proteins in Young and Older Adults","official_title":"Effects of Resistance and Endurance Training on Synthesis of Individual Muscle Proteins in Young and Older Adults","primary_completion_date":"2011-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-02-28","last_update":"2011-12-12","description":"Loss of skeletal muscle strength and skeletal muscle mass occurs with of aging. This are-related decline in skeletal muscle mass and skeletal muscle strength is a major underlying factor contributing to many of the metabolic disorders and frailty of the investigators rapidly expanding aging population. Endurance (aerobic) and resistance exercise training programs have been shown to effectively reverse the age-related decline in metabolic and contractile muscle functions. The investigators will measure synthesis rates of individual muscle proteins in 36 each of young (18-30 yrs) and 36 older (> 65 yrs) people to determine their response to 8 weeks each of endurance, resistance, combined endurance and resistance training, or placebo exercise training. Hypotheses. 1. to measure fractional synthesis rates of multiple muscle proteins and identify those that are enhanced by an endurance exercise program 2. to determine whether changes in protein synthesis in response to endurance exercise programs are dependent on age 3. to measure fractional muscle synthesis rates of multiple muscle proteins and to identify those that are enhanced by a resistance exercise program 4. to determine whether changes in protein synthesis in response to resistance exercise programs are dependent on age","other_id":"07-007689","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy\r\n\r\n          -  18 to 30 or >65 years\r\n\r\n          -  Males and Females\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Regular Exercise Program\r\n\r\n          -  Smoking\r\n\r\n          -  Cardiometabolic Disease (diabetes, cardiovascular disease, thyroid disorders)\r\n\r\n          -  Drugs known to impair metabolic function (beta blockers, steroids)\r\n\r\n          -  Allergies to lidocaine\r\n\r\n          -  Physical disability that precludes exercise\r\n      ","sponsor":"Mayo Clinic","sponsor_type":"Other","conditions":"Sarcopenia","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Endurance exercise","description":"Participants will perform 8-weeks of endurance exercise training. Participants will train 5 days per week for 60 min at 65% of VO2 peak."},{"intervention_type":"Behavioral","name":"Behavioral: Resistance exercise","description":"Participants will perform 8-weeks of resistance exercise training. Participants will train 4 days per week for ~60 min. Two days will focus on lower body resistance training and two days will focus on upper body."},{"intervention_type":"Behavioral","name":"Behavioral: Control/Combined training","description":"Participants will perform 8-weeks of no exercise (control), followed by 8-weeks of combined endurance and resistance training. Participants will endurance train 5 days per week for 30 min at 65% of VO2 peak and resistance train 4 days per week for 30 min."}],"outcomes":[{"outcome_type":"primary","measure":"Skeletal Muscle Protein Synthesis","time_frame":"Measured at week 0 (baseline) and week 8","description":"The investigators will determine the change from baseline in skeletal muscle protein synthesis. Measurments will be performed at baseline and following 8 weeks of exercise training."},{"outcome_type":"secondary","measure":"Mitochondrial Function","time_frame":"Measured at week 0 (baseline) and week 8","description":"The investigators will determine the change from baseline in mitochondrial function. Measurments will be performed at baseline and following 8 weeks of exercise training."}]}
{"nct_id":"NCT00682747","start_date":"2008-05-31","phase":"Phase 2","enrollment":13,"brief_title":"Hyperbaric Oxygen for the Treatment of a Dry Mouth Which Occurred After Radiotherapy","official_title":"Randomized Phase II Trial of Hyperbaric Oxygen for the Treatment of Radiation-induced Xerostomia","primary_completion_date":"2011-03-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2011-03-31","last_update":"2016-10-27","description":"The purpose of this study is to determine whether hyperbaric oxygen is effective in the treatment of a dry mouth that occured after radiotherapy for head and neck tumours.","other_id":"KKSH-037","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  complaints of xerostomia (visual analogue scale)\r\n\r\n          -  at least 6 months after radiotherapy of the head and neck region including all\r\n             salivary glands with at least 50 Gy\r\n\r\n          -  objective hyposalivation / xerostomia (at rest < 0,25 ml saliva per minute, stimulated\r\n             < 0,1 ml saliva per minute)\r\n\r\n          -  patient must have given written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  prior radiotherapy was an intensity modulated radiotherapy\r\n\r\n          -  prior hyperbaric oxygen therapy after radiotherapy\r\n\r\n          -  conditions which might be an additional risk for the treatment with hyperbaric oxygen\r\n             such as spontaneous pneumothorax within the last two years, surgery of the eardrum or\r\n             the middle ear, acute infection of the upper airways, not adequately treated epilepsy,\r\n             concurrent radio- or chemotherapy, hereditary spherocytosis, psychosis, lung\r\n             emphysema, asthma, severe COPD, prior surgery of the thorax, pace maker\r\n\r\n          -  myocardial infarction within the last 6 months\r\n\r\n          -  drug therapy which might induce xerostomia\r\n\r\n          -  known intolerance or hypersensitivity to Wrigley's Freident\r\n\r\n          -  pregnancy or breast-feeding women (for women aged less than 60 years a pregnancy test\r\n             is mandatory)\r\n\r\n          -  women of childbearing potential with unclear contraception. The following\r\n             contraceptive methods are recommended: combined oral contraceptives or\r\n             progesterone-only pill, hormone-dispensing or copper intra-uterine system, hormone\r\n             patches, long-acting injections, vaginal ring\r\n\r\n          -  treatment with other investigational drugs or participation in another clinical trial\r\n             within 30 days prior to enrollment\r\n\r\n          -  refusal of cooperation or consent\r\n      ","sponsor":"Thomas Kuhnt","sponsor_type":"Other","conditions":"Radiation-induced Xerostomia","interventions":[{"intervention_type":"Drug","name":"Drug: Hyperbaric oxygen","description":"40 treatments with hyperbaric oxygen once per day, five days per week, 2.4 ATA, 100 % oxygen (10-15 minutes compression with air, 90 min of oxygen breathing - two 10 minutes break for breathing air after each 30 minutes of oxygen, 10 minutes decompression with oxygen"}],"outcomes":[{"outcome_type":"primary","measure":"change of overall salivation (millilitre per minute over 5 minutes measured at rest and after provocation) in percentages","time_frame":"baseline compared with measures on day 28, 56 and 146"},{"outcome_type":"secondary","measure":"Number of Adverse Events in all patients as a Measure of Safety and Tolerability","time_frame":"baseline until 4 weeks after end of study treatment"},{"outcome_type":"secondary","measure":"Xerostomia scores assessed by investigator according to Eisbruch et.al.","time_frame":"baseline compared with measures on day 28, 56 and 146"},{"outcome_type":"secondary","measure":"Improvement of symptoms/discomfort due to xerestomia assessed by the patient on a visual analogue scale","time_frame":"baseline compared with measures on day 28, 56 and 146"},{"outcome_type":"secondary","measure":"quality of life measures (EORTC QLQ-H&N 35)","time_frame":"baseline compared with measures on day 28, 56 and 146"}]}
{"nct_id":"NCT00618098","start_date":"2008-05-31","phase":"Phase 3","enrollment":200,"brief_title":"Study of Octaplex (Human Prothrombin Complex Concentrate) and Fresh Frozen Plasma in Patients Under Vitamin K Therapy Antagonist Needing Urgent Surgery or Invasive Procedures","official_title":"A Randomized, Open-label, Efficacy and Safety Study of Octaplex and Fresh Frozen Plasma (FFP) in Patients Under Vitamin K Antagonist Therapy With the Need for Urgent Surgery or Invasive Procedures","primary_completion_date":"2012-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-08-31","last_update":"2016-10-18","description":"The purpose of this study is to determine whether Octaplex (human prothrombin complex concentrate) can reverse the effects of anticoagulants when compared to the standard treatment of fresh frozen plasma (FFP).","other_id":"LEX-205","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female patients at least 18 years of age.\r\n\r\n          -  Patients receiving oral anticoagulation with coumadin or warfarin derived agents.\r\n\r\n          -  Patients who have need for urgent surgery or an invasive procedure up to 8 hours after\r\n             admission or identification of a patient currently hospitalized, where oral or\r\n             parenteral vitamin K therapy is deemed too slow in its action for reversal of coumadin\r\n             or warfarin anticoagulant effects.\r\n\r\n          -  Patients with an international normalized ratio (INR) of 2.0 or above.\r\n\r\n          -  Patients who have given written informed consent or for whom written informed consent\r\n             has been obtained from the patient's legal representative on their behalf.\r\n\r\n          -  Patients able and willing to comply with the procedures laid out in the study\r\n             protocol. In the case of unconscious and/or incapacitated patients, the willingness of\r\n             the patient's legal representative for the patient to undergo the procedures laid out\r\n             in the study protocol.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with a life expectancy of less than 48 hours (eg, patients with a Glasgow\r\n             Coma Scale (GCS) equal to 3 or a head abbreviated injury score (AIS) of 6, patients\r\n             requiring continuous inotropic or pressor support, patients status post-cardiac\r\n             arrest).\r\n\r\n          -  Patients with a history within the last 6 months of disseminated intravascular\r\n             coagulation (DIC), or hyperfibrinolysis.\r\n\r\n          -  Patients with a known congenital coagulation disorder.\r\n\r\n          -  Patients with known antiphospholipid antibody syndrome or have known lupus\r\n             anticoagulant antibodies.\r\n\r\n          -  Patients with present or past specific factor inhibitor activity.\r\n\r\n          -  Patients with thrombocytopenia of < 80,000 or a history of heparin induced\r\n             thrombocytopenia (HIT).\r\n\r\n          -  Patients having received heparin of any type or any non-coumadin or warfarin\r\n             anticoagulant immediately prior and/or intended to be given within the first 1 hour\r\n             post-infusion.\r\n\r\n          -  Patients who have received vitamin K more than 3 hours prior to the infusion of study\r\n             drug.\r\n\r\n          -  Patients with a history of hypersensitivity to plasma-derived products.\r\n\r\n          -  Pregnant or nursing women.\r\n\r\n          -  Patients participating in another clinical treatment study currently or during the\r\n             past 1 month prior to study inclusion.\r\n\r\n          -  Patients previously enrolled in this study.\r\n      ","sponsor":"Octapharma","sponsor_type":"Industry","conditions":"Reversal of Anticoagulant Treatment","interventions":[{"intervention_type":"Biological","name":"Biological: Octaplex (human prothrombin complex concentrate)","description":"INR is determined 15 minutes after the end of each infusion. Each dose (mL/kg body weight) was calculated as = ln(INR/1.4)/0.52. The maximum dose for initial treatment was not to exceed 5500 IU. If the INR is  1.5 after the initial infusion, additional infusions will be repeated until the INR was < 1.5. Octaplex (500 units, IU) is supplied in vials and was reconstituted with 20 mL of Water for Injection (Ph.Eur.)."},{"intervention_type":"Biological","name":"Biological: Fresh frozen plasma","description":"INR is determined 15 minutes after the end of each infusion. The initial dose is 10 mL/kg for a participant with an initial INR of < 3 and 15 mL/kg for a participant with an initial INR of  3. If the INR is  1.5 after the initial infusion, additional infusions of 5 mL/kg will be repeated until the INR was < 1.5. Fresh frozen plasma is supplied by the blood bank at each study site and will be prepared and handled according to the site's standard practice."}],"outcomes":[{"outcome_type":"primary","measure":"There will be two primary end points in this study. The first primary efficacy endpoint is the correction of INR to < 1.5.","time_frame":"15 minutes after the end of first infusion of OCTAPLEX or FFP"},{"outcome_type":"secondary","measure":"number of intra-operative red blood cell units (RBC) transfused","time_frame":"intra-operative"}]}
{"nct_id":"NCT01073475","start_date":"2008-05-31","enrollment":750000,"brief_title":"Maternal Newborn Health Registry","official_title":"Global Network for Women's and Children's Health Research Maternal Newborn Health Registry","primary_completion_date":"2020-05-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2020-05-31","last_update":"2019-03-04","description":"The primary purpose of this population-based study is to quantify and understand the trends in pregnancy outcomes in defined low-resource geographic areas over time, in order to provide population-based data on stillbirths, neonatal and maternal mortality.","other_id":"CP MNH","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","population":"All pregnant women meeting participant-level criteria and the infant(s) from their\r\n        pregnancy.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Community-level\r\n\r\n               -  Appropriate for long-term registry data collection and the conduct of ongoing\r\n                  Global Network research\r\n\r\n               -  At least 300 deliveries per year\r\n\r\n          -  Participant-level\r\n\r\n               -  Pregnant women intending to deliver within study cluster\r\n\r\n               -  Women who deliver within the study cluster\r\n\r\n               -  Women who reside in the community but are transferred for care at delivery\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Participant-level\r\n\r\n               -  Opt out of consent to include data in the study\r\n      ","sponsor":"NICHD Global Network for Women's and Children's Health","sponsor_type":"Other","conditions":"Pregnancy Outcome Trends in Low-resource Geographic Areas","interventions":[{"intervention_type":"Other","name":"Other: There is no intervention associated with this study.","description":"There is no intervention associated with this study"}],"outcomes":[{"outcome_type":"primary","measure":"Maternal mortality rate","time_frame":"42 days post delivery","description":"Maternal mortality rate by site and cluster"},{"outcome_type":"primary","measure":"Stillbirth rate","time_frame":"Delivery","description":"Stillbirth rate by site and cluster"},{"outcome_type":"primary","measure":"Early neonatal mortality rate","time_frame":"28 days post delivery","description":"ENM by site and by cluster"},{"outcome_type":"secondary","measure":"Cause of maternal death at less than or equal to 42 days","time_frame":"42 days post delivery","description":"Data collected by site and by cluster"},{"outcome_type":"secondary","measure":"Cause of neonatal death at less than or equal to 28 days","time_frame":"28 days post delivery","description":"Data collected by site and by cluster"}]}
{"nct_id":"NCT00679367","start_date":"2008-05-31","phase":"Phase 2","enrollment":16,"brief_title":"Melphalan, Lenalidomide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis","official_title":"A Phase II Trial of MRD (Melphalan, Lenalidomide and Dexamethasone) for Patients With AL Amyloidosis","primary_completion_date":"2015-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-05-31","last_update":"2017-02-20","description":"RATIONALE: Drugs used in chemotherapy, such as melphalan and dexamethasone, work in different ways to stop the growth of abnormal plasma cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop the abnormal plasma cells from growing. Giving melphalan together with lenalidomide and dexamethasone may be an effective treatment for primary systemic amyloidosis. PURPOSE: This phase II trial is studying the side effects and how well giving melphalan together with lenalidomide and dexamethasone works in treating patients with primary systemic amyloidosis.","other_id":"CDR0000595759","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        DISEASE CHARACTERISTICS:\r\n\r\n          -  Diagnosis of primary systemic amyloidosis\r\n\r\n        PATIENT CHARACTERISTICS:\r\n\r\n          -  Not pregnant\r\n\r\n          -  Negative pregnancy test\r\n\r\n          -  Able to tolerate an anticoagulation regimen (e.g., 325 mg of aspirin per day,\r\n             therapeutic warfarin, or low molecular weight heparin)\r\n\r\n        PRIOR CONCURRENT THERAPY:\r\n\r\n          -  Recovered from prior therapy\r\n\r\n               -  Permanent or stable side effects/changes allowed\r\n\r\n          -  Prior chemotherapy, thalidomide, lenalidomide, or steroids for amyloidosis allowed\r\n\r\n          -  More than 4 weeks since prior and no other concurrent cytotoxic chemotherapy or\r\n             radiotherapy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  No secondary or familial amyloidosis\r\n\r\n          -  No multiple myeloma ( 30% plasma cells in bone marrow biopsy or lytic bone lesions)\r\n\r\n          -  No prior cumulative doses of oral melphalan > 200 mg\r\n\r\n          -  No more than one prior course of high-dose melphalan with stem cell transplant\r\n      ","sponsor":"Boston Medical Center","sponsor_type":"Other","conditions":"Multiple Myeloma","interventions":[{"intervention_type":"Drug","name":"Drug: dexamethasone","description":"40 mg once weekly"},{"intervention_type":"Drug","name":"Drug: lenalidomide","description":"10 mg/day D1-21"},{"intervention_type":"Drug","name":"Drug: melphalan","description":"5 mg/m2 D1-4"}],"outcomes":[{"outcome_type":"secondary","measure":"Number of Participants Removed From Study Due to Toxicities","time_frame":"One year","description":"Number of study participants removed from study treatment due to toxicities"},{"outcome_type":"primary","measure":"Number of Participants With Hematologic Response","time_frame":"one year","description":"Complete hematologic response: Absence of detectable monoclonal protein in serum or urine by immunofixation electrophoresis, bone marrow biopsy with less than 5% plasma cells without clonal dominance of kappa or lambda isotype, and normal serum free light chain assay.\r\nPartial hematologic response: Amyloid patients have highly individualized measures of disease burden. For patients with detectable and quantifiable monoclonal marrow plasmacytosis, a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells. For patients with a detectable monoclonal peak on serum or urine protein electrophoresis, a reduction in the peak height of 50% or more. For patients with quantifiable urinary kappa or lambda chain concentration, a 50% reduction in daily light chain excretion (concentration x 24 hour urine volume). For patients with an elevated serum free light chain assay, reduction of 50% or more."},{"outcome_type":"secondary","measure":"Number of Organs Improved or Stable Based on Description Below:","time_frame":"one year","description":"Renal response - > 50% decrease in daily 24 hour proteinuria, without worsening renal insufficiency.\r\nHepatic response - decrease of 2 centimeters or more of the liver span and/or decrease of the alkaline phosphatase by 50% if elevated at baseline.\r\nCardiac response - decrease of 2 millimeters or more in mean left ventricular wall thickness in patients with baseline wall thickness > 11 mm or a decrease in New York Heart Association heart failure class.\r\nAutonomic nervous system response - resolution of orthostatic vital signs and symptoms, and resolution of symptoms of gastric atony or of functional ileus.\r\nGastrointestinal response - a greater than one grade improvement in diarrhea due to biopsy proven amyloid.\r\nPeripheral nervous system response - resolution of clinical signs of peripheral neuropathy."}]}
{"nct_id":"NCT00683787","start_date":"2008-05-31","phase":"Phase 2","enrollment":8,"brief_title":"Docetaxel With or Without Vandetanib in Treating Patients With Metastatic Stomach Cancer or Gastroesophageal Junction Cancer","official_title":"Multicenter Randomized Phase II Trial of Docetaxel With/Without VANDETANIB for Advanced Gastroesophageal Cancer","primary_completion_date":"2009-04-30","study_type":"Interventional","rec_status":"Terminated","completion_date":"2011-03-31","last_update":"2015-01-08","description":"RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether docetaxel is more effective when given together with or without vandetanib. PURPOSE: This randomized phase II trial is studying docetaxel to see how well it works compared with docetaxel given together with vandetanib in treating patients with metastatic stomach cancer or gastroesophageal junction cancer.","other_id":"CDR0000596150","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        DISEASE CHARACTERISTICS:\r\n\r\n          -  Histologically confirmed gastric adenocarcinoma or gastroesophageal junction cancer\r\n\r\n               -  Metastatic disease\r\n\r\n          -  Measurable disease\r\n\r\n          -  No symptomatic CNS metastases\r\n\r\n        PATIENT CHARACTERISTICS:\r\n\r\n        Inclusion criteria:\r\n\r\n          -  ECOG performance status 0-1\r\n\r\n          -  Life expectancy  3 months\r\n\r\n          -  ANC  1,500/L\r\n\r\n          -  Platelet count  100,000/L\r\n\r\n          -  Bilirubin  1.5 times upper limit of normal (ULN)\r\n\r\n          -  Creatinine < 1.5 times ULN OR creatinine clearance  50 mL/min\r\n\r\n          -  Potassium  4.0 mEq/L (supplementation allowed) and  the CTCAE grade 1 upper limit\r\n\r\n          -  Magnesium normal (supplementation allowed) and  the CTCAE grade 1 upper limit\r\n\r\n          -  Calcium normal and corrected serum calcium  the CTCAE grade 1 upper limit\r\n\r\n               -  In cases where the serum calcium is below the normal range, calcium (adjusted for\r\n                  albumin) normal OR ionized calcium normal\r\n\r\n          -  ALT and AST  2.5 times ULN\r\n\r\n          -  Alkaline phosphatase  2.5 times ULN\r\n\r\n          -  Not pregnant or nursing\r\n\r\n          -  Negative pregnancy test\r\n\r\n          -  Fertile patients must use effective contraception during and for up to 12 weeks after\r\n             completion of study therapy\r\n\r\n          -  Atrial fibrillation allowed if controlled by medication\r\n\r\n          -  LVEF  45% by MUGA or ECHO\r\n\r\n        Exclusion criteria:\r\n\r\n          -  Evidence of severe or uncontrolled systemic disease\r\n\r\n          -  Any concurrent condition which makes it undesirable for the patient to participate in\r\n             the trial or which would jeopardize study compliance, in the Investigator's opinion\r\n\r\n          -  Uncontrolled infection\r\n\r\n          -  Coagulopathy (including warfarin or anti-coagulant related) or bleeding disorder\r\n\r\n          -  Peripheral neuropathy  grade 2\r\n\r\n          -  Clinically significant cardiac event, including myocardial infarction or New York\r\n             Heart Association class II-IV heart disease within the past 3 months\r\n\r\n          -  Presence of cardiac disease that, in the opinion of the Investigator, increases the\r\n             risk of ventricular arrhythmia\r\n\r\n          -  History of arrhythmia (i.e., multifocal premature ventricular contractions, bigeminy,\r\n             trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) which is\r\n             symptomatic or requires treatment (CTCAE grade 3) OR asymptomatic sustained\r\n             ventricular tachycardia\r\n\r\n          -  History of QTc prolongation as a result of other medication that required\r\n             discontinuation of that medication\r\n\r\n          -  Congenital long QT syndrome or a first degree relative with unexplained sudden death\r\n             under 40 years of age\r\n\r\n          -  Presence of left bundle branch block\r\n\r\n          -  QTc with Bazett's correction that is unmeasurable or  480 msec on screening ECG\r\n\r\n               -  If a patient has QTc  480 msec on screening ECG, the screen ECG may be repeated\r\n                  twice (at least 24 hours apart)\r\n\r\n               -  The average OTc from the three screening ECGs must be < 480 msec in order for the\r\n                  patient to be eligible for the study\r\n\r\n          -  Hypertension not controlled by medical therapy (systolic blood pressure [BP] > 160 mm\r\n             Hg or diastolic BP > 100 mm Hg)\r\n\r\n          -  Currently active diarrhea ( grade 2) that may affect the ability of the patient to\r\n             absorb vandetanib\r\n\r\n          -  Previous or current malignancies of other histologies within the past 5 years, with\r\n             the exception of cervical carcinoma in situ and adequately treated basal cell or\r\n             squamous cell carcinoma of the skin\r\n\r\n        PRIOR CONCURRENT THERAPY:\r\n\r\n          -  Recovered from all prior therapy\r\n\r\n          -  At least 4 weeks since prior chemotherapy or radiotherapy\r\n\r\n          -  No more than one prior chemotherapy regimen for metastatic disease\r\n\r\n               -  Prior adjuvant therapy, including chemoradiotherapy, allowed\r\n\r\n          -  At least 2 weeks since prior palliative radiotherapy\r\n\r\n               -  Up to 3750 cGy palliative radiotherapy to the stomach allowed\r\n\r\n          -  No prior therapy with docetaxel\r\n\r\n          -  More than 30 days since prior investigational agents\r\n\r\n          -  More than 4 weeks since prior and no concurrent or planned participation in another\r\n             experimental drug study\r\n\r\n          -  More than 4 weeks since prior major surgery and recovered\r\n\r\n          -  More than 2 weeks since prior and no concurrent medication that may cause QTc\r\n             prolongation or induce Torsades de Pointes\r\n\r\n          -  No concurrent amiodarone\r\n\r\n          -  No concurrent potent inducers of CYP3A4 function (e.g., rifampicin, rifabutin,\r\n             phenytoin, carbamazepine, barbiturates, or Hypericum perforatum [St. John wort])\r\n\r\n          -  No prior enrollment or randomization to treatment in the present study\r\n      ","sponsor":"Roswell Park Cancer Institute","sponsor_type":"Other","conditions":"Gastric Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: docetaxel","description":"Given IV once every 3 weeks"},{"intervention_type":"Drug","name":"Drug: vandetanib","description":"Oral vandetanib once daily"}],"outcomes":[{"outcome_type":"primary","measure":"Overall Response Rate","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Progression-free Survival","time_frame":"3 years"},{"outcome_type":"secondary","measure":"Overall Survival","time_frame":"3 years"},{"outcome_type":"secondary","measure":"Toxicity","time_frame":"1 year"}]}
{"nct_id":"NCT00682097","start_date":"2008-05-31","phase":"Phase 1","enrollment":55,"brief_title":"A Multiple Ascending Dose Study of RO4998452 in Patients With Type 2 Diabetes Mellitus.","official_title":"A Randomized, Double-Blind, Multiple-Ascending-Dose, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO4998452 Following Oral Administrations in Patients With Type 2 Diabetes Mellitus","primary_completion_date":"2009-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-03-31","last_update":"2016-11-02","description":"This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of RO4998452 compared to placebo in patients with type 2 diabetes mellitus. Successive cohorts of patients will be randomized to receive either active drug, at escalating doses, or placebo. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.","other_id":"BP21549","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  adult patients, 18-65 years of age;\r\n\r\n          -  type 2 diabetes;\r\n\r\n          -  either treated by diet and exercise alone or with metformin.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  type 1 diabetes mellitus;\r\n\r\n          -  uncontrolled hypertension;\r\n\r\n          -  clinically severe diabetic complications.\r\n      ","sponsor":"Hoffmann-La Roche","sponsor_type":"Industry","conditions":"Diabetes Mellitus Type 2","interventions":[{"intervention_type":"Drug","name":"Drug: RO4998452","description":"Escalating oral doses"},{"intervention_type":"Drug","name":"Drug: placebo","description":"Oral doses"}],"outcomes":[{"outcome_type":"primary","measure":"AEs, laboratory parameters, vital signs.","time_frame":"Throughout study"},{"outcome_type":"primary","measure":"AUC0-24h, Cmax","time_frame":"Days 1 and 14"},{"outcome_type":"secondary","measure":"Parameters of glucose metabolism","time_frame":"Throughout study"}]}
{"nct_id":"NCT00612235","start_date":"2008-04-30","enrollment":80,"brief_title":"Premenstrual Dysphoric Disorder and Antiepileptic Drugs","official_title":"Comparison of Different Antiepileptic Drug Monotherapies for the Occurrence of Premenstrual Dysphoric Disorder Among Women With Epilepsy","primary_completion_date":"2010-06-30","study_type":"Observational","rec_status":"Completed","completion_date":"2010-06-30","last_update":"2018-10-26","description":"This study is being done to determine if there are differences in mood during the menstrual cycle among women with epilepsy who take various different antiepileptic drugs and women without epilepsy.","other_id":"2007P000357","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"Female","minimum_age":18,"maximum_age":45,"population":"Three regional epilepsy centers","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Women with epilepsy, 18-45 years of age. Women will be on one of 4 established ( 3\r\n             months) AED monotherapies: LTG, CBZ, PHT or LEV and with documented therapeutic range\r\n             serum AED level during the year prior to enrollment.\r\n\r\n          -  Normal Control women, 18-45 years of age, in good general health by history\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Concomitant use of prescribed or OTC reproductive hormones\r\n\r\n          -  Concomitant use of antidepressant and anxiolytic medications such as SSRIs, bupropion,\r\n             tricyclics, benzodiazepines\r\n      ","sponsor":"Beth Israel Deaconess Medical Center","sponsor_type":"Other","conditions":"Epilepsy","interventions":[{"intervention_type":"Drug","name":"Drug: Lamotrigine","description":"Subjects had at least 3 months on a stable dosage of lamotrigine monotherapy."},{"intervention_type":"Drug","name":"Drug: Levetiracetam","description":"Subjects had at least 3 months on a stable dosage of levetiracetam monotherapy."},{"intervention_type":"Drug","name":"Drug: Carbamazepine","description":"Subjects had at least 3 months on a stable dosage of carbamazepine monotherapy."},{"intervention_type":"Other","name":"Other: No Intervention","description":"No intervention was given"}],"outcomes":[{"outcome_type":"primary","measure":"To Determine if the Frequency of Premenstrual Dysphoric Disorder Differs Among Various Antiepileptic Drug Monotherapies.","time_frame":"Assessment of PMDD Designation after two consecutive menstrual cycles","description":"Proportion of women who meet the Endicott Daily Record of Severity of Problems (DRSP) criteria for PMDD for two consecutive menstrual cycles in women with epilepsy and the control group (no epilepsy). To meet PMDD designation, women must have reached the PMDD criteria for both menstrual cycles. The less stringent threshold for PMDD designation referred to (1) having more severe symptoms during the premenstrual phase than during the midfollicular phase regardless of whether the midfollicular symptom scores exceeded the Endicott cutoff and (2) meeting the other three Endicott criteria"},{"outcome_type":"primary","measure":"Proportion of Women With PMDD in WWE and the Control Group","time_frame":"Assessment of PMDD Designation after two consecutive menstrual cycles","description":"Proportion of women who meet the Endicott Daily Record of Severity of Problems (DRSP) criteria for PMDD for two consecutive menstrual cycles in women with epilepsy and the control group (no epilepsy). To meet PMDD designation, women must have reached the PMDD criteria for both menstrual cycles. The less stringent threshold for PMDD designation referred to (1) having more severe symptoms during the premenstrual phase than during the midfollicular phase regardless of whether the midfollicular symptom scores exceeded the Endicott cutoff and (2) meeting the other three Endicott criteria."}]}
{"nct_id":"NCT00858806","start_date":"2008-04-30","phase":"Phase 2","enrollment":78,"brief_title":"Intermittent Imatinib Treatment in Chronic Myeloid Leukemia and Philadelphia Chromosome (Ph+CML) Patients Who Achieved a Complete Cytogenetic Response (CCgR) on Standard Imatinib Therapy","official_title":"Phase II Explorative Study of Intermittent Imatinib (IM) Treatment (INTERIM) in Elderly Patients With Ph+ Chronic Myeloid Leukemia (CML) Who Achieved a Stable Complete Cytogenetic Response (CCgR) With Standard IM Therapy","primary_completion_date":"2010-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-12-31","last_update":"2014-12-03","description":"Standard therapy with Imatinib (IM) significantly prolongs the survival of Ph+CML patients who obtain a complete cytogenetic response (CCgR). Elderly patients (i.e., at least 65 years) have similar cytogenetic responses and survival, but they usually show a low compliance. The aim of the study is to evaluate the percentage of elderly patients who maintain a CCgR with intermittent imatinib therapy with respect to standard daily administration.","other_id":"2007-005102-42","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patients with confirmed diagnosis of Ph+ CML in CP\r\n\r\n          2. Age  65 years old\r\n\r\n          3. Stable CCgR after at least 2 years of treatment with standard (daily administration)\r\n             IM therapy documented by 2 consecutive cytogenetic analysis over the last 12 month\r\n\r\n          4. Karnofsky performance status >50%\r\n\r\n          5. Written informed consent prior to any study procedures being performed.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients with Ph+ CML in accelerated/blastic phase (AP/BP), or in late CP, previously\r\n             treated (i.e. IFN alpha+/- low dose Ara-C, Hydroxyurea, allogeneic stem cell\r\n             transplantation, etc etc.)\r\n\r\n          2. Age < 65 years old\r\n\r\n          3. No stable CCgR after at least 2 years of treatment with standard (daily\r\n             administration) IM therapy documented by 2 consecutive cytogenetic analysis over the\r\n             last 12 month\r\n\r\n          4. Karnofsky performance status <50%\r\n\r\n          5. No written informed consent prior to any study procedures being performed.\r\n      ","sponsor":"Universit degli Studi di Brescia","sponsor_type":"Other","conditions":"Chronic Myeloid Leukemia","interventions":[{"intervention_type":"Drug","name":"Drug: Imatinib","description":"Intermittent Imatinib administration.\r\n1 week on / 1 week off for the 1st month(weeks 1-4)\r\n2 weeks on / 2 weeks off for the 2nd and the 3rd month (weeks 5-12)\r\n1 month on / 1 month off from the 4th month thereafter (weeks 13 on)"}],"outcomes":[{"outcome_type":"primary","measure":"The proportion of patients who remain in CCgR with INTERIM given for one year.","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Variation of BCR-ABL transcript level","time_frame":"1 year"}]}
{"nct_id":"NCT00662831","start_date":"2008-04-30","phase":"Phase 2/Phase 3","enrollment":276,"brief_title":"Study Of The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients","official_title":"A 6 Month, Prospective, Randomized, Double Blind, Placebo-Controlled, Parallel Group, Multiple Center Trial To Evaluate The Efficacy And Safety Of Fragmin In The Treatment Of Chronic Neuroischaemic Foot Ulcers In Diabetic Patients","primary_completion_date":"2010-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-10-31","last_update":"2018-12-19","description":"The purpose of the study isto see the effect of Fragmin on the healing of diabetic foot ulcers by determining the number of subjects with 50% reduction in ulcer surface area including intact skin healing.","other_id":"A6301083","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female subjects 18 years of age with type 1 or type 2 diabetes.\r\n\r\n          -  Subjects with peripheral occlusive arterial disease (PAOD) and a neuropathy disability\r\n             score (NDS) of >3\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subjects who have undergone vascular reconstruction or angioplasty less than 1 month\r\n             prior to randomization. Subjects with an ulcer grading of 0 or 3 and staging of A, B\r\n             or D according to the University of Texas wound classification system.\r\n\r\n          -  Subjects with a known bleeding disorder or evidence of active bleeding.\r\n      ","sponsor":"Pfizer","sponsor_type":"Industry","conditions":"Diabetic Foot Ulcer","interventions":[{"intervention_type":"Drug","name":"Drug: Fragmin/ Dalteparin Sodium","description":"Pre-filled syringes containing a single dose of 5000 IU Fragmin/ Dalteparin Sodium."},{"intervention_type":"Drug","name":"Drug: Placebo for Fragmin/ Dalteparin Sodium","description":"Pre-filled syringes containing a single dose of placebo for 5000 IU Fragmin/ Dalteparin Sodium."}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Including Intact Skin Healing","time_frame":"Week 24 [end of treatment (EOT)] or early termination","description":"University of Texas (UT) system assesses ulcer depth, wound infection and clinical signs of lower-extremity ischemia. UT Wound Classification (1C/2C) was based on grade (0= healed site to 3= penetrating wound to bone or joint) and stage (A= clean wounds to D= ischaemic infected wounds) of wounds. Participants were evaluated at 4 stratums: Stratum 1: Toe pressure>30 mm of mercury (mmHg) and UT grade and stage 1C. Stratum 2: Toe pressure<=30 mmHg and UT grade and stage 1C. Stratum 3: Toe pressure>30 mmHg and UT grade and stage 2C. Stratum 4: Toe pressure<=30 mmHg and UT grade and stage 2C."},{"outcome_type":"secondary","measure":"Number of Participants With Intact Skin Healing","time_frame":"Week 24 (EOT) or early termination","description":"Intact skin healing was defined as 100 percent reduction in ulcer surface area with full epithelialisation. UT system assesses ulcer depth, wound infection and clinical signs of lower-extremity ischemia. Participants were evaluated at 4 stratums: Stratum 1: Toe pressure>30 mm of mercury (mmHg) and UT grade and stage 1C. Stratum 2: Toe pressure<=30 mmHg and UT grade and stage 1C. Stratum 3: Toe pressure>30 mmHg and UT grade and stage 2C. Stratum 4: Toe pressure<=30 mmHg and UT grade and stage 2C."},{"outcome_type":"secondary","measure":"Number of Participants Who Underwent Any Amputation","time_frame":"Week 24 (EOT) or early termination","description":"Any amputation included both major and minor amputations. A major amputation was defined as above the ankle and was reported as below-the-knee and above-the-knee amputations. A minor amputation was defined as below the ankle amputation."},{"outcome_type":"secondary","measure":"Number of Participants Who Underwent Major and Minor Amputation","time_frame":"Week 24 (EOT) or early termination","description":"A major amputation was defined as above the ankle and was reported as below-the-knee and above-the-knee amputations. A minor amputation was defined as below the ankle amputation."},{"outcome_type":"secondary","measure":"Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Excluding Intact Skin Healing","time_frame":"Week 24 (EOT) or early termination","description":"University of Texas (UT) system assesses ulcer depth, wound infection and clinical signs of lower-extremity ischemia. UT Wound Classification (1C/2C) was based on grade (0= healed site to 3= penetrating wound to bone or joint) and stage (A= clean wounds to D= ischaemic infected wounds) of wounds. Participants were evaluated at 4 stratums: Stratum 1: Toe pressure>30 mm of mercury (mmHg) and UT grade and stage 1C. Stratum 2: Toe pressure<=30 mmHg and UT grade and stage 1C. Stratum 3: Toe pressure>30 mmHg and UT grade and stage 2C. Stratum 4: Toe pressure<=30 mmHg and UT grade and stage 2C."},{"outcome_type":"secondary","measure":"Number of Participants Who Died","time_frame":"Week 24 (EOT) or early termination"},{"outcome_type":"secondary","measure":"Number of Participants With Major Cardiovascular Disease Events (MCVE)","time_frame":"Week 24 (EOT) or early termination","description":"Major cardiovascular events were defined as death due to vascular cause; non-fatal myocardial infarction (MI) excluding procedure related to MI; coronary revascularization procedures not related to MIs; hospitalization for unstable angina or non-fatal stroke."},{"outcome_type":"secondary","measure":"Time to Intact Skin Healing","time_frame":"Week 24 (EOT) or early termination","description":"Median time taken to achieve intact skin healing which was defined as 100 percent reduction in ulcer surface area with full epithelialisation."},{"outcome_type":"secondary","measure":"Median Time to First Amputation","time_frame":"Week 24 (EOT) or early termination"},{"outcome_type":"secondary","measure":"Euro Quality of Life-5 Dimensions (EQ-5D)- Utility Score","time_frame":"Baseline and Week 24 (EOT or early termination)","description":"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. It assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, \"confined to bed\"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."},{"outcome_type":"secondary","measure":"Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)","time_frame":"Baseline and Week 24 (EOT or early termination)","description":"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state."},{"outcome_type":"secondary","measure":"36-Item Short-Form Health Survey (SF-36) Score","time_frame":"Baseline and Week 24 (EOT or early termination)","description":"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning)."},{"outcome_type":"secondary","measure":"11-point Likert Pain Scale","time_frame":"Baseline and Week 24 (EOT or early termination)","description":"The 11 point Likert pain scale which used a 0 (no pain) to 10 (worst possible pain) point rating system was used to assess participant's pain score. No distinction was made between neuropathy and inflammatory (nociceptive) pain."},{"outcome_type":"secondary","measure":"Transcutaneous Local Tissue Oxygenation (pO2)","time_frame":"Baseline and Week 24 (EOT or early termination)","description":"Transcutaneous pO2 was assessed at the dorsum of the foot in the first intermetatarsal space using an appropriately calibrated instrument. The skin oxygen partial pressure was determined by measuring the oxygen reduction current by means of a measuring cell."},{"outcome_type":"other","measure":"Number of All Hemorrhages","time_frame":"Week 24 (EOT) or early termination","description":"Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin more than or equal to 20 gram (g)/litre (L) (2 g/ decilitre [dL]), clinically overt bleeding leading to transfusion of more than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular). Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding."},{"outcome_type":"other","measure":"Number of Major and Minor Hemorrhages","time_frame":"Week 24 (EOT) or early termination","description":"Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin more than or equal to 20 gram (g)/litre (L) (2 g/ decilitre [dL]), clinically overt bleeding leading to transfusion of more than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular). Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding."},{"outcome_type":"other","measure":"Number of Clinically Relevant Minor Hemorrhages and Trivial Hemorrhages","time_frame":"Week 24 (EOT) or early termination","description":"Clinically relevant minor (non-major) bleeding was defined as any bleeding compromising hemodynamics, leading to hospitalization, subcutaneous haematoma more than 25 cm^2, intramuscular haematoma, epistaxis lasting for more than 5 minutes, spontaneous gingival bleeding, macroscopic hematuria and gastrointestinal hemorrhage (including at least 1 episode of melaena or hematemesis), rectal blood loss, hemoptysis, and any other bleeding with clinical consequences. Trivial bleeding was defined as all minor bleeding that did not meet the definition of clinically relevant minor bleeding."}]}
{"nct_id":"NCT00681993","start_date":"2008-04-30","phase":"N/A","enrollment":35,"brief_title":"Trial of Partial Breast Irradiation With Various Concurrent Chemotherapy Regimens","official_title":"\"A Feasibility Trial of Partial Breast Irradiation With Various Concurrent Chemotherapy Regimens (PBIC)\"","primary_completion_date":"2012-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-03-04","last_update":"2019-01-22","description":"Breast conserving therapy, (BCT), which consists of wide local excision of the tumor followed by 6 weeks of whole breast irradiation, (WBI), is integral to the management of breast cancer. Evidence now suggests that WBI may not be necessary and treatment to the involved area only, partial breast irradiation, (PBI), may suffice. PBI can be achieved by interstitial or intracavitary brachytherapy, intra-op, or post op external beam radiation therapy. The feasibility, toxicity and efficacy of PBI are currently being studied in both the U.S. and Europe. Review of smaller studies suggests that PBI will prove to be comparable to WBI. Chemotherapy combined with radiation has been shown to increase local control in BCT when compared to radiation alone. However there is little data on how sequencing or timing of these therapies with respect to one another affect outcome. As a result there is no consensus about the optimal combination. There are real and potential benefits to concurrent chemo-radiation therapy. Concurrent therapy 1) allows both treatments to start closer to surgery, theoretically maximizing the benefits of each modality; 2) shortens the overall treatment program; and 3) may also improve local control via chemo-sensitization of residual cancer cells. However, concurrent chemotherapy and WBI have been associated with prohibitive skin toxicity. Since less breast tissue is treated with PBI, this skin toxicity may no longer be prohibitive. We have shown in J0381 that PBI and concurrent dose dense AC is safe. As a follow-up, we propose a phase I/II trial addressing the toxicity and efficacy associated with PBI delivered concurrently with various chemotherapy regimens.","other_id":"J0805","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Eligibility Criteria:\r\n\r\n        Each of the criteria in the following section must be met in order for a patient to be\r\n        considered eligible for registration.\r\n\r\n          -  Patient must be older than 18 years of age\r\n\r\n          -  Patients must have histologically confirmed (by routine H&E staining) adenocarcinoma\r\n             of the breast, with the primary tumor < 4 cm and 0 - 3 positive axillary lymph nodes\r\n             (pathologic T1-2, pathologic N0 -N1, M0). Patients with squamous carcinomas or\r\n             sarcomas of the breast cancer are NOT eligible.\r\n\r\n          -  Patient must have a history and physical within six weeks prior to the start of any\r\n             protocol therapy.\r\n\r\n          -  Patient must have had a bilateral mammogram prior to surgery.\r\n\r\n          -  Patients must have undergone a segmental mastectomy (SM) with a level I and ll\r\n             axillary dissection or sentinel lymph node biopsy. Surgical margins at time of SM must\r\n             be negative (> or = 2 mm) for both invasive carcinoma and for non-invasive ductal\r\n             carcinoma. Patients who have post-operative margins which are negative but less than\r\n             2mm will be considered eligible if the surgeon states that the margin in question\r\n             could not be improved.\r\n\r\n          -  Patient must have a Medical Oncology consult and be recommended to receive one of the\r\n             following regimens: Cyclophosphamide and Doxorubicin (AC); Taxotere, Doxorubicin and\r\n             Cyclophosphamide (TAC); Taxotere and Cyclophosphamide (TC) or Taxotere, Carboplatin\r\n             and Trastuzumab (TCH) prior to registration. The use of additional chemotherapy,\r\n             hormonal therapy or Trastuzumab after the initial regimen is at the discretion of the\r\n             medical oncologist.\r\n\r\n          -  Patients must be registered such that radiation therapy begins no sooner than 7 days\r\n             prior to, but no later than 7 days after, day 1 of cycle 1 (C1D1). Patient must start\r\n             chemotherapy and radiation less than 14 weeks from the last breast surgical procedure.\r\n\r\n          -  Patients must NOT have received any neo adjuvant chemo or hormonal therapy for the\r\n             current cancer.\r\n\r\n          -  Patients must have a performance status 0 or 1 by ECOG criteria\r\n\r\n          -  Patients must not have received prior radiation therapy to the involved breast at any\r\n             time for any reason.\r\n\r\n          -  Any patient with active local-regional disease prior to registration is not eligible.\r\n\r\n          -  No other prior malignancy is allowed except for adequately treated basal cell or\r\n             squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the\r\n             patient has been disease-free for 5 years.\r\n\r\n          -  Patients must not be pregnant due to the potential for fetal harm as a result of this\r\n             treatment regimen. Women of child-bearing potential must use effective non hormonal\r\n             contraception while undergoing radiation therapy. Women of child-bearing potential\r\n             must also have a negative pregnancy test within six weeks prior to start of protocol\r\n             therapy.\r\n\r\n          -  Patients must not have a serious medical or psychiatric illness which prevents\r\n             informed consent or compliance with treatment.\r\n\r\n          -  All patients must be informed of the investigational nature of this study and given\r\n             written informed consent in accordance with institutional and federal guidelines.\r\n      ","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","sponsor_type":"Other","conditions":"Breast Cancer","interventions":[{"intervention_type":"Other","name":"Other: Standard Dose Dense Doxorubucin and Cyclophosphamide","description":"4 cycles of Standard Dose-Dense Doxorubucin and Cyclophosphamide and concurrent radiation therapy at a dose of 270 cGy per fraction for 15 fractions to a total dose of 40.5 Gy. Treatments will be given Monday through Friday for three weeks. Radiation therapy may start 7 days before, but no later than 7 days after, day 1 of cycle 1 of chemotherapy (C1D1)."},{"intervention_type":"Other","name":"Other: Standard Doxorubucin and Cyclophosphamide","description":"4 cycles of Standard Dose Doxorubucin and Cyclophosphamide and concurrent radiation therapy at a dose of 270 cGy per fraction for 15 fractions to a total dose of 40.5 Gy. Treatments will be given Monday through Friday for three weeks. Radiation therapy may start 7 days before, but no later than 7 days after, day 1 of cycle 1 of chemotherapy (C1D1)."},{"intervention_type":"Other","name":"Other: Standard Docetaxel, Carboplatin, and Herceptin","description":"6 cycles of Standard Docetaxel, Carboplatin and Herceptin chemotherapy with concurrent radiation therapy at a dose of 270 cGy per fraction for 15 fractions to a total dose of 40.5 Gy. Treatments will be given Monday through Friday for three weeks. Radiation therapy may start 7 days before, but no later than 7 days after, day 1 of cycle 1 of chemotherapy (C1D1)."},{"intervention_type":"Other","name":"Other: Standard Docetaxel, Doxorubucin and Cyclophosphamide","description":"3 cycles of Standard Docetaxel, Doxorubucin and Cyclophosphamide chemotherapy with concurrent radiation therapy at a dose of 270 cGy per fraction for 15 fractions to a total dose of 40.5 Gy. Treatments will be given Monday through Friday for three weeks. Radiation therapy may start 7 days before, but no later than 7 days after, day 1 of cycle 1 of chemotherapy (C1D1)."},{"intervention_type":"Other","name":"Other: Standard Docetaxel and Cyclophosphamide","description":"4 cycles of Standard Docetaxel and Cyclophosphamide chemotherapy with concurrent radiation therapy at a dose of 270 cGy per fraction for 15 fractions to a total dose of 40.5 Gy. Treatments will be given Monday through Friday for three weeks. Radiation therapy may start 7 days before, but no later than 7 days after, day 1 of cycle 1 of chemotherapy (C1D1)."}],"outcomes":[{"outcome_type":"primary","measure":"Acute skin toxicities of partial breast irradiation concurrent with chemotherapy (PBIC)","time_frame":"up to 5 years post-intervention","description":"Acute Skin toxicity will be scored on a scale ranging from 0-4, where a higher score reflects more severe toxicity:\r\n0= no change; 1= follicular, fain or dull erythema/epilation/dry/desquamation/decreased swelling; 2= tender or bright erythemal patchy moist desquamation/moderate edema; 3= confluent moist desquamation other than skin folds, pitting edema; 4= ulceration, hemorrhage, necrosis."},{"outcome_type":"primary","measure":"Late skin toxicities of PBIC","time_frame":"up to 5 years post-intervention","description":"Late Skin toxicity will be scored on a scale ranging from 0-4, where a higher score reflects more severe toxicity:\r\n0= none; 1= slight atrophy, pigmentation change, some hair loss; 2= patchy atrophy, moderate telangiectasias, total hair loss; 3= marked atrophy, gross telangiectasias; 4= ulceration"},{"outcome_type":"primary","measure":"Subcutaneous tissue toxicities of PBIC","time_frame":"up to 5 years post-intervention","description":"Subcutaneous tissue toxicity will be scored on a scale ranging from 0-4, where a higher score reflects more severe toxicity:\r\n0= none; 1= slight induration (fibrosis) and loss of subcutaneous fat; 2= moderate fibrosis but asymptomatic; slight field contracture; <10% linear reduction; 3= severe induration and loss subcutaneous tissue; field contracture >10% linear reduction; 4= necrosis"},{"outcome_type":"secondary","measure":"Cosmetic effect of PBIC","time_frame":"up to 5 years post-intervention","description":"Number of participants with Poor, Fair, Good, or Excellent cosmetic effect after PBIC. Cosmetic effect will be graded by the investigator and participant as specified by the grading criteria in the Study Protocol (grading criteria description too large for this field)."},{"outcome_type":"secondary","measure":"Local control rate of patients treated with PBIC.","time_frame":"up to 5 years post-intervention"}]}
{"nct_id":"NCT00674180","start_date":"2008-04-30","enrollment":588,"brief_title":"Data Analysis of a Managed Care Weight Reduction Trial","official_title":"Data Analysis of a Managed Care Weight Reduction Trial","primary_completion_date":"2008-04-30","study_type":"Observational","rec_status":"Completed","completion_date":"2010-01-31","last_update":"2020-01-10","description":"This study will involve secondary data analysis for a study done by Wylie-Rosett et al. in 2001 that evaluated the costs and effects of incremental components of a weight-loss program. Data analysis will involve cross-sectional and predictive analyses and may include: regression analyses to determine predictors of weight loss and cardiovascular risk, correlations between weight reduction strategies and biological indices, and interactions between biomarkers of inflammation and traditional cardiovascular risk factors. This data will also be available for economic modeling.","other_id":"2008-833","observational_model":"Other","time_perspective":"Other","sampling_method":"Non-Probability Sample","gender":"All","population":"Participants were recruited from an HMO's patient population and from New Hyde Park, NY.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  BMI of more than 25 (or a BMI of 24 or more plus 1 cardiovascular risk factor), and\r\n             the willingness to follow the study protocol, which included a refundable $100 deposit\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Intention to move beyond commuting distance in the next 12 months,\r\n\r\n          -  Medical conditions that would interfere with study participation,\r\n\r\n          -  Unwillingness to follow the study protocol.\r\n      ","sponsor":"Albert Einstein College of Medicine","sponsor_type":"Other","conditions":"Overweight|Obesity","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Workbook","description":"The workbook developed as a do-it-yourself program in which participants completed self-help sheets that guided them to sections of the workbook most salient to their needs."},{"intervention_type":"Behavioral","name":"Behavioral: Computer Intervention","description":"The computer intervention was provided using a network system that included a file server plus 5 multimedia computers with touch screens. The expert software program was written to guide participants in using the workbook and tail behavioral goals based on their prior computer use and the answers they provided on baseline questionnaires. The three primary paths in the computer addressed nutrition, fitness, and psychobehavioral content."},{"intervention_type":"Behavioral","name":"Behavioral: Staff Consultation","description":"The staff consultation component included 6 closed-group workshop sessions and up to 18 telephone or face-to-face consultations with a registered dietician and/or a cognitive behavioral therapist. The workshop curriculum focused on specific activities and assignments in the workbook, and it encouraged use of the computer to identify problems and issues."}],"outcomes":[{"outcome_type":"primary","measure":"weight loss","time_frame":"1 year"},{"outcome_type":"secondary","measure":"diabetes and cardiovascular risk","time_frame":"1 year"}]}
{"nct_id":"NCT00532181","start_date":"2008-04-30","phase":"Early Phase 1","brief_title":"Micro-Health Insurance in Cambodia","official_title":"A Randomized Control Trial of Micro-Health Insurance in Cambodia","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2011-12-31","last_update":"2007-09-20","description":"People who buy insurance are sicker and/or more risk averse than those who don't. Also, Micro-health insurance increases utilization of public health care facilities and protects against asset sales.","other_id":"CPHS Protocol 2007-3-48","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Must be in a village where the health insurance program is being offered.\r\n      ","sponsor":"University of California, Berkeley","sponsor_type":"Other","conditions":"Health Insurance Sale|Health Utilization|Asset Sales, Investment and Saving Behaviors","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Savings Behavior and Consumer's Approach to Risk"}],"outcomes":[{"outcome_type":"primary","measure":"Better Understand Health Utilization Behavior in Cambodia"},{"outcome_type":"secondary","measure":"Better Understand asset sales, investment and saving behaviors"}]}
{"nct_id":"NCT01219426","start_date":"2008-03-31","brief_title":"A Transversal Study for the French Validation of Two Assessment Tools of Gambling Related Cognitions.","official_title":"A Transversal Study for the French Validation of Two Assessment Tools of Gambling Related Cognitions.","primary_completion_date":"2008-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2008-12-31","last_update":"2011-05-20","description":"This study is divided into two stages. In the first stage, students from the University of Nantes completed the two assessment tools of gambling related cognitions (GABS : Gambling Attitudes and Beliefs Survey ; GRCS : Gambling Related Cognitions Scale), and a reference tool for gambling problem severity (SOGS : South Oaks Gambling Screen). In the second stage, consecutive pathological gamblers seeking treatment at the University Hospital of Nantes completed the three questionnaires. Only questionnaires from participants who reported gambling at least one time in the past year were kept for analyses.Responses of students gamblers and pathological gamblers presenting for treatment have been compiled for analysis.The main objective of the study is to validate the French adaptations of the GABS and the GRCS, and to explore their psychometric properties and structures.","other_id":"08/3-F","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"To be more than 18 years old (the legal age to gamble in France)","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  To be more than 18 years old (the legal age to gamble in France)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  None\r\n      ","sponsor":"Nantes University Hospital","sponsor_type":"Other","conditions":"Gambling","interventions":[{"intervention_type":"Other","name":"Other: Filling of three questionnaires","description":"The only intervention of the study was the completion of the three questionnaires, and of a mini-questionnaire assessing gender, age, and gambling activities."}],"outcomes":{}}
{"nct_id":"NCT01196754","start_date":"2008-03-31","phase":"N/A","enrollment":12,"brief_title":"Pharmacokinetic of Sevoflurane During a 48h Sedation in Intensive Care Unit With AnaConDa","official_title":"Pharmacokinetic of Sevoflurane During a 48h Sedation in ICU With AnaConDa","primary_completion_date":"2009-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-05-31","last_update":"2010-09-08","description":"This is a prospective clinical monocentric study in ICU with sedated ventilated patients with sevoflurane during 48 h with the AnaConda system, establishing pharmacokinetic model of sevoflurane.","other_id":"CHU-0079","primary_purpose":"Screening","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adult patients ventilated more than 48 h\r\n\r\n          -  Stable respiratory and hemodynamic conditions\r\n\r\n          -  Consent of patients or family\r\n\r\n          -  Arterial line\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Acute kidney injury\r\n\r\n          -  Obesity\r\n\r\n          -  Sevoflurane anaphylaxia\r\n      ","sponsor":"University Hospital, Clermont-Ferrand","sponsor_type":"Other","conditions":"Sedation","interventions":[{"intervention_type":"Other","name":"Other: sevoflurane"}],"outcomes":[{"outcome_type":"primary","measure":"Determination of plasmatic concentrations of sévoflurane at different times of a 48h sedation of sévoflurane.","time_frame":"during 48 hours"},{"outcome_type":"secondary","measure":"Determination of plasmatic concentrations of HFIP and fluoride at different times of a 48h sedation of sévoflurane. Determination of a pharmacokinetic model of sévoflurane.","time_frame":"during 48 hours"}]}
{"nct_id":"NCT00667277","start_date":"2008-03-31","phase":"Phase 2","enrollment":13,"brief_title":"Phase II Study of Bevacizumab (Avastin) in Myelofibrosis","official_title":"Phase II Study of Bevacizumab (Avastin) in Myelofibrosis","primary_completion_date":"2010-03-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2010-03-31","last_update":"2014-08-22","description":"Myelofibrosis is the gradual replacement of bone marrow (place where most new blood cells are produced) by fibrous tissue which reduces the body's ability to produce new blood cells and results in the development of chronic anemia (low red blood cell count). One of the main distinctions of myelofibrosis is \"extramedullary hematopoiesis\", the migration or traveling of the blood-forming cells out of the bones to other parts of the body, such as the liver or spleen, resulting in an enlarged spleen and liver. There is not a standard treatment for myelofibrosis, therefore there is no medication that is specifically used in the treatment of myelofibrosis. Bevacizumab (Avastin) targets and stops a growth factor in the body that helps produce the type of fibrous tissue that is gradually replacing the bone marrow in the bones. The purpose of this study is to find out how safe and effective bevacizumab is in treating myelofibrosis. The investigators also wish to find out important biologic characteristics or features of myelofibrosis (how it works and operates) during the time of study participation through an additional correlative biomarker study (MPD-RC #107). The purpose of the biomarker study is to understand the causes of MPD and to develop improved methods for the diagnosis and treatment of these diseases, while the main study is trying to find out how well bevacizumab will work in treating the disease.","other_id":"GCO 07-0548-00103","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosis of primary myelofibrosis, essential thrombocythemia related myelofibrosis,\r\n             and polycythemia vera related myelofibrosis requiring therapy, including those\r\n             previously treated and relapsed or refractory, or, if newly diagnosed, with\r\n             intermediate or high risk according to Lille scoring system\r\n\r\n          -  Patients not willing to undergo, not a candidate for, or not having a donor for a bone\r\n             marrow transplant.\r\n\r\n          -  Signed informed consent: Patients must have signed consents for both the bevacizumab\r\n             protocol and for the mandatory biomarker MDP-RC 107 protocol to be eligible to\r\n             participate.\r\n\r\n          -  Patients must have been off any IM-directed therapy for 2 weeks prior to entering this\r\n             study and have recovered from the toxic effects (grade 0-1) of that therapy.\r\n\r\n          -  Serum bilirubin levels less than or equal to 2 times the upper limit of the normal\r\n             range for the laboratory (ULN). Higher levels are acceptable if these can be\r\n             attributed by treating physician to active hemolysis or ineffective erythropoiesis due\r\n             to myelofibrosis;\r\n\r\n          -  Serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) levels\r\n             less than or equal to 2x ULN.\r\n\r\n          -  Serum creatinine levels less than or equal to 1.5 x ULN.\r\n\r\n          -  Women of childbearing potential must have a negative serum or urine pregnancy test\r\n             prior to bevacizumab treatment and should be advised to avoid becoming pregnant. Men\r\n             must be advised to not father a child while receiving treatment with bevacizumab. Both\r\n             women of childbearing potential and men must practice effective methods of\r\n             contraception (those generally accepted as standard of care measures). Women of child\r\n             bearing potential are women who are not menopausal for 12 months or who have not\r\n             undergone previous surgical sterilization.\r\n\r\n          -  Age > 18 years.\r\n\r\n          -  LVEF >50% by MUGA or ECHO (only in patients with prior exposure to anthracyclines).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Nursing and pregnant females. Should a woman become pregnant or suspect she is\r\n             pregnant while participating in this study, she should inform her treating physician\r\n             immediately.\r\n\r\n          -  Inadequately controlled hypertension (defined as systolic blood pressure >140 and/or\r\n             diastolic blood pressure >90 mmHg on antihypertensive medications) within 4 weeks\r\n             prior to entering this study\r\n\r\n          -  Any prior history of hypertensive crisis or hypertensive encephalopathy\r\n\r\n          -  New York Heart Association (NYHA) Grade II or greater congestive heart failure\r\n\r\n          -  Unstable angina\r\n\r\n          -  History of myocardial infarction within 6 months\r\n\r\n          -  History of stroke or transient ischemic attack within 6 months\r\n\r\n          -  History of Budd-Chiari Syndrome or portal vein thrombosis.\r\n\r\n          -  Significant vascular disease (e.g., aortic aneurysm, aortic dissection)\r\n\r\n          -  Symptomatic peripheral vascular disease\r\n\r\n          -  Evidence of bleeding diathesis or clinically significant coagulopathy\r\n\r\n          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days,\r\n             or anticipation of the need for major surgical procedure during the course of the\r\n             study\r\n\r\n          -  Core biopsy or other minor surgical procedure, excluding placement of a vascular\r\n             access device or bone marrow biopsy, within 7 days prior to study enrollment\r\n\r\n          -  Proteinuria at screening as demonstrated by either\r\n\r\n               -  Urine protein:creatinine (UPC) ratio greater than or equal to 1.0 at screening OR\r\n\r\n               -  Urinalysis with proteinuria  2+ (patients discovered to have 2+ proteinuria on\r\n                  dipstick urinalysis at baseline should undergo a 24 hour urine collection and\r\n                  must demonstrate  1g of protein in 24 hours to be eligible).\r\n\r\n          -  History of abdominal fistula, gastrointestinal perforation, peptic ulcer, or\r\n             intra-abdominal abscess within 6 months\r\n\r\n          -  Ongoing serious, non-healing wound, ulcer, or bone fracture\r\n\r\n          -  Known hypersensitivity to any component of bevacizumab\r\n\r\n          -  Patients with a history of DVT and/or a CNS thrombotic or hemorrhagic event within the\r\n             past 6 months.\r\n\r\n          -  Patients on anticoagulation therapy for a variety of conditions such as prosthetic\r\n             heart valves or chronic atrial fibrillation.\r\n      ","sponsor":"Ronald Hoffman","sponsor_type":"Other","conditions":"Myelofibrosis","interventions":[{"intervention_type":"Drug","name":"Drug: bevacizumab (Avastin)","description":"15 mg/kg of bevacizumab by IV infusion once every 3 weeks (1 cycle) for 12 weeks (4 cycles)"}],"outcomes":[{"outcome_type":"primary","measure":"Reason for Therapy Discontinuation","time_frame":"2 years","description":"Patient outcomes for myelofibrosis patients treated on a single agent bevacizumab.\r\nThe two subjects who withdrew consent prior to initiation of therapy are included in the \"patient refusal\" category."},{"outcome_type":"secondary","measure":"Number of Cycles","time_frame":"2 years","description":"Number of cycles of bevacizumab received. Patients received bevacizumab as a single agent at a dose of 15 mg/kg intravenously on Day 1 of a 21-day cycle."}]}
{"nct_id":"NCT00649584","start_date":"2008-03-31","phase":"Phase 1","enrollment":44,"brief_title":"A Phase I Dose Escalation Study of SGN-35 Alone and in Combination With Gemcitabine for CD30-Positive Malignancies","official_title":"A Phase I Dose Escalation Study of Weekly SGN-35 Monotherapy and in Combination With Gemcitabine in Patients With Relapsed/Refractory CD30-positive Hematologic Malignancies","primary_completion_date":"2010-02-28","study_type":"Interventional","rec_status":"Terminated","completion_date":"2010-02-28","last_update":"2014-12-18","description":"This study will examine the safety profile of SGN-35 alone and in combination with gemcitabine. The study will test increasing doses of SGN-35 given weekly to small groups of patients.","other_id":"SG035-0002","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":12,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically confirmed CD30-positive hematologic malignancy.\r\n\r\n          -  Patients with HL must have failed systemic chemotherapy.\r\n\r\n          -  Patients with other CD30-positive malignancies (including ALCL) must be beyond first\r\n             remission or refractory to front line chemotherapy.\r\n\r\n          -  Patients must have measurable disease of at least 1.5 cm as documented by radiographic\r\n             technique.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Current diagnosis of primary cutaneous ALCL (systemic ALCL eligible).\r\n\r\n          -  History of allogeneic stem cell transplant.\r\n\r\n          -  Patients who have had previous treatment with any anti-CD30 antibody.\r\n      ","sponsor":"Seagen Inc.","sponsor_type":"Industry","conditions":"Disease, Hodgkin|Lymphoma, Large-Cell, Anaplastic|Lymphoma, Non-Hodgkin","interventions":[{"intervention_type":"Drug","name":"Drug: SGN-35","description":"IV; 0.4 up to 1.8 mg/kg weekly 3 out of 4 weeks; minimum of two 28-day cycles"},{"intervention_type":"Drug","name":"Drug: gemcitabine","description":"IV; 1000 mg/m2 weekly 3 out of 4 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of adverse events and laboratory abnormalities","time_frame":"1 month after last dose"},{"outcome_type":"secondary","measure":"PK profile","time_frame":"2 months after last dose"},{"outcome_type":"secondary","measure":"Immunogenicity (anti-SGN-35 antibodies)","time_frame":"1 month after last dose"},{"outcome_type":"secondary","measure":"Anti-tumor activity","time_frame":"1 month after last dose"}]}
{"nct_id":"NCT00735501","start_date":"2008-03-31","enrollment":314,"brief_title":"Observational Study to Observe the Safety of Levemir Treatment in Patients With Type 2 Diabetes","official_title":"Safety of Levemir (Insulin Detemir) Treatment in Patients With Type 2 Diabetes","primary_completion_date":"2010-05-31","study_type":"Observational","rec_status":"Completed","completion_date":"2010-05-31","last_update":"2014-10-29","description":"This observational study is conducted in Europe. The study aims to observe the incidence of serious adverse drug reactions in subjects with type 2 diabetes during Levemir treatment.","other_id":"NN304-1938","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"Patients aged 18 or above, with type 2 diabetes, who together with their physician, have\r\n        decided to switch to Levemir from human basal insulin treatment","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Any patient with type 2 diabetes\r\n\r\n          -  Currently treated with basal human insulin therapy (basal only or in combination with\r\n             oral glucose lowering drugs or other insulin)\r\n\r\n          -  Selection of patients will be at the discretion of the treating physician after the\r\n             decision to prescribe one of the study products to the patient\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Known or suspected allergy to study product(s) or related products.\r\n\r\n          -  Pregnancy or breastfeeding or intention of becoming pregnant within the next 6 months\r\n      ","sponsor":"Novo Nordisk A/S","sponsor_type":"Industry","conditions":"Diabetes|Diabetes Mellitus, Type 2","interventions":[{"intervention_type":"Drug","name":"Drug: insulin detemir","description":"Start dose and frequency as well as dose alterations to be determined by the physician according to normal clinical evaluation"}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of serious adverse drug reactions, including major hypoglycaemic events","time_frame":"After 26 weeks"},{"outcome_type":"secondary","measure":"Number of all hypoglycaemic events","time_frame":"at 12 weeks and 26 weeks"},{"outcome_type":"secondary","measure":"Number of all adverse drug reactions","time_frame":"after 12 and 26 weeks"},{"outcome_type":"secondary","measure":"HbA1c","time_frame":"at 12 and 26 weeks"},{"outcome_type":"secondary","measure":"Variability in fasting plasma glucose (FPG) values and average FPG levels at visits","time_frame":"at 12 and 26 weeks"},{"outcome_type":"secondary","measure":"Weight changes","time_frame":"at 12 and 26 weeks"}]}
{"nct_id":"NCT00635726","start_date":"2008-02-29","phase":"Phase 2","enrollment":41,"brief_title":"Methotrexate, Vinblastine, Doxorubicin and Cisplatin (MVAC) Followed by Gemcitabine Plus Cisplatin (GEM+CDDP) in Locally Advanced or Metastatic Bladder Cancer","official_title":"Sequential High Dose MVAC (Methotrexate, Vinblastine, Doxorubicin and Cisplatin), Followed by Gemcitabine Plus Cisplatin in Treating Patients With Locally Advanced or Metastatic Bladder Cancer","primary_completion_date":"2013-02-28","study_type":"Interventional","rec_status":"Terminated","completion_date":"2013-02-28","last_update":"2015-10-08","description":"This phase II trial will study the effectiveness and toxicity of sequential high dose MVAC followed by gemcitabine and cisplatin, as first line treatment in patients with locally advanced or metastatic bladder cancer.","other_id":"CT/07.16","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically or cytologically confirmed transitional cell carcinoma of the urinary\r\n             bladder.\r\n\r\n          -  Metastatic or locally advanced disease.\r\n\r\n          -  No prior chemotherapy.\r\n\r\n          -  Performance status (World Health Organization) 0-2.\r\n\r\n          -  Measurable or evaluable disease.\r\n\r\n          -  Measurable disease is defined as at least 1 unidimensional measurable lesion\r\n\r\n             20 mm by conventional techniques or 1 bidimensionally measurable lesion  20 X 10 mm.\r\n             Lesions that are smaller or uni- or bidimensionally unmeasurable are considered as\r\n             evaluable disease.\r\n\r\n          -  Adequate liver (bilirubin  1.5 Upper Normal Limit, serum glutamate-pyruvate\r\n             aminotransferase/serum glutamic pyruvic transaminase  2 Upper Normal Limit, ALP  2.5\r\n             Upper Normal Limit), renal (creatinine  1.5 Upper Normal Limit) and bone marrow\r\n             (absolute neutrophil count  1,500/mm3, platelet count  100,000/mm3) function.\r\n\r\n          -  Life expectancy > 3 months.\r\n\r\n          -  Patients must be able to understand the nature of this study and give written informed\r\n             consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of serious cardiac disease (unstable angina, severe congestive heart failure,\r\n             myocardial infarction within the previous 6 months, ventricular arrhythmias).\r\n\r\n          -  Second primary malignancy, except for non-melanoma skin cancer and in situ cervical\r\n             cancer.\r\n\r\n          -  Active infection.\r\n\r\n          -  Uncontrolled inflammation.\r\n\r\n          -  Pregnant or lactating women.\r\n\r\n          -  Psychiatric illness or social situation that would preclude study compliance.\r\n      ","sponsor":"Hellenic Oncology Research Group","sponsor_type":"Other","conditions":"Bladder Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Methotrexate","description":"Methotrexate intravenous (IV) 30 mgr/m2 on day 1 every 2 weeks for 6 courses"},{"intervention_type":"Drug","name":"Drug: Vinblastine","description":"Vinblastine IV 3 mgr/m2 on day 1 every 2 weeks for 6 courses"},{"intervention_type":"Drug","name":"Drug: Doxorubicin","description":"Doxorubicin IV 30 mgr/m2 on day 2 every 2 weeks for 6 courses"},{"intervention_type":"Drug","name":"Drug: Cisplatin","description":"Cisplatin IV 70 mgr/m2 on day 2 every 2 weeks for 6 courses"},{"intervention_type":"Drug","name":"Drug: Cisplatin","description":"Cisplatin IV 70 mgr/m2 on day 1 every 3 weeks for 4 courses"},{"intervention_type":"Drug","name":"Drug: Gemcitabine","description":"Gemcitabine 1000 mgr/m2 on days 1 and 8 every 3 weeks for 4 courses"}],"outcomes":[{"outcome_type":"primary","measure":"Overall response rate","time_frame":"Objective responses confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) (on 3rd and 6th cycle)"},{"outcome_type":"secondary","measure":"Time to tumor progression","time_frame":"1-year"},{"outcome_type":"secondary","measure":"Overall survival","time_frame":"1-year"},{"outcome_type":"secondary","measure":"Toxicity profile","time_frame":"Toxicity assessment on each chemotherapy cycle"}]}
{"nct_id":"NCT00125658","start_date":"2008-02-29","phase":"N/A","enrollment":14,"brief_title":"Mechanisms of Upper-Extremity Motor Recovery in Post-stroke Hemiparesis","official_title":"Mechanisms of Upper-Extremity Motor Recovery in Post-stroke Hemiparesis","primary_completion_date":"2009-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-09-30","last_update":"2017-06-23","description":"The results of this study will provide sound, scientific evidence of physiologic mechanisms responsible for upper-extremity weakness; evidence of the processes involved in neuromuscular adaptation; and will elucidate the relationship between impairment and motor disability in post-stroke hemiparesis.","other_id":"B3964-R","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Clinical diagnosis of cerebrovascular accident\r\n\r\n          -  Single event\r\n\r\n          -  Unilateral hemiplegia\r\n\r\n          -  Between 6 months and 18 months post-event\r\n\r\n          -  Impairment of upper-extremity function\r\n\r\n          -  Ability to produce partial range of motion out of plane of gravity at shoulder, elbow,\r\n             and wrist\r\n\r\n          -  At least 10 degrees of wrist motion (any 10 degrees), and finger flexion/extension in\r\n             2 fingers\r\n\r\n          -  Cognitive ability to follow 3-step commands\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Unstable or uncontrolled blood pressure\r\n\r\n          -  Uncontrolled seizures\r\n\r\n          -  Flaccid hemiplegia\r\n\r\n          -  Severe cognitive impairment\r\n      ","sponsor":"VA Office of Research and Development","sponsor_type":"U.S. Fed","conditions":"Cerebrovascular Accident","interventions":[{"intervention_type":"Other","name":"Other: Control","description":"Following an initial testing session, you will complete a 5 week no training period. At the end of this period you will then participate in a 20 week therapy program - 10 weeks of Functional Task Practice (FTP) followed by 10 weeks of Power training (dynamic resistance exercise). Each 10 week block has 30 therapy sessions for a total of 60 sessions, each lasting approximately 1-1/2 hours. Follow up evaluations will be scheduled at 6 months and 12 months after completion of the entire 20 week therapy program."},{"intervention_type":"Other","name":"Other: Experimental","description":"Following an initial testing session, you will complete a 5 week no training period. At the end of this period you will then participate in a 20 week therapy program - 10 weeks of Power training (dynamic resistance exercise) followed by 10 weeks of Functional Task Practice (FTP). Each 10 week block has 30 therapy sessions for a total of 60 sessions, each lasting approximately 1-1/2 hours. Follow up evaluations will be scheduled at 6 months and 12 months after completion of the entire 20 week therapy program."}],"outcomes":[{"outcome_type":"primary","measure":"Change in Trunk Displacement","time_frame":"baseline, 10 weeks, 20 weeks","description":"Distance (in cm) of trunk lean while performing reach-to-grasp. This information is obtained from kinematics/3D motion capture and is used to inform regarding compensatory use of the trunk as compared to active motion of the shoulder, elbow, wrist, and hand, during reach-to-grasp. Change scores are expressed relative to baseline."},{"outcome_type":"primary","measure":"Change in Shoulder Flexion","time_frame":"baseline, 10 weeks, 20 weeks","description":"joint range of motion obtained using kinematics / motion capture. Change scores expressed relative to baseline."},{"outcome_type":"primary","measure":"Change in Elbow Extension Range of Motion","time_frame":"baseline, 10 weeks, 20 weeks","description":"joint range of motion obtained using kinematics / motion capture. Change scores are expressed relative to baseline."},{"outcome_type":"primary","measure":"Upper-extremity Fugl-Meyer Motor Assessment","time_frame":"baseline, 10 weeks, 20 weeks","description":"The Fugl-Meyer Motor Assessment is a standardized scale used to measure the magnitude of motor impairment (severity) following stroke. There are separate sub-scales for the upper and lower extremities. Here we used the upper-extremity component; the full range of the scale is 0 - 66 points. Higher scores approaching 66 represent better, and lower scores approaching 0 worse, motor function. There is a significant ceiling effect with the FMA, thus a score of 66 points does not mean an individual with stroke has fully recovered. Data are change scores expressed relative to baseline."},{"outcome_type":"secondary","measure":"Movement Speed","time_frame":"baseline, 10 weeks, 20 weeks","description":"peak velocity of movement (cm/s) during reach-to-grasp, obtained using kinematics/motion capture. Data are change scores expressed relative to baseline."},{"outcome_type":"secondary","measure":"Movement Accuracy (Reach Path Ratio, RPR)","time_frame":"baseline, 10 weeks, 20 weeks","description":"Measure is derived from kinematics/motion analysis. RPR = ratio of actual reach trajectory relative to an idealized straight line. Data are change scores, expressed relative to baseline."},{"outcome_type":"secondary","measure":"Movement Smoothness","time_frame":"baseline, 10 weeks, 20 weeks","description":"Movement smoothness is determined by assessing the number of sub movements (i.e., starts and stops) that can be identified during performance of a task. Here the task was reach-to-grasp. Sub movement are identified from kinematics/3D motion analysis. Sub-movements represent discontinuities or \"jerky\" movements. For example, skilled reaching is smooth and may reveal a single movement unit; in contrast, unskilled movements will reveal multiple movement units (i.e., starts and stops). As a performer practices and learns the movement, the number of sub movements is reduced. Sub movements can also present in persons with pathology. The unit of sub movements is whole numbers, or counts, of the sub movements. Data are change scores, expressed relative to baseline."}]}
{"nct_id":"NCT01021527","start_date":"2008-02-29","phase":"Phase 1","enrollment":12,"brief_title":"A Study to Assess the Effects of Exenatide on Insulin Secretion Rates Using a Graded Infusion of Intravenous Glucose (0000-099)(COMPLETED)","official_title":"A Randomized, 4-Period Study to Assess the Effects of Exenatide on Insulin Secretion Rates Using a Graded Infusion of Intravenous Glucose","primary_completion_date":"2008-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-04-30","last_update":"2015-04-28","description":"A four-period study to evaluate if the grade glucose infusion procedure will be able to detect an increase in beta-cell glucose sensitivity from exenatide compared to no treatment in healthy subjects.","other_id":"0000-099","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subject is in good health\r\n\r\n          -  Subject is a non-smoker\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subject has irritable bowel disease\r\n\r\n          -  Subject has a history of cancer\r\n\r\n          -  Subject has a history of hypertension requiring treatment\r\n\r\n          -  Subject is unable to refrain from the use of any prescription or non-prescription\r\n             medication\r\n\r\n          -  Subject consumes excessive amounts of alcohol or caffeine\r\n\r\n          -  Subject has had major surgery, donated blood or participated in another\r\n             investigational study in the past 4 weeks\r\n      ","sponsor":"Merck Sharp & Dohme Corp.","sponsor_type":"Industry","conditions":"Healthy","interventions":[{"intervention_type":"Other","name":"Other: Comparator: Treatment A","description":"No Treatment"},{"intervention_type":"Drug","name":"Drug: Comparator: Treatment B","description":"single dose administration of exenatide 5ug by subcutaneous injection"},{"intervention_type":"Drug","name":"Drug: Comparator: Treatment C","description":"single dose administration of exenatide 10ug by subcutaneous injection"},{"intervention_type":"Procedure","name":"Procedure: Comparator: graded glucose infusion","description":"A stepwise graded infusion of glucose (20% dextrose [D20]) with a stable rate of infusion maintained for 40 minutes for each of 5 steps, with steps at 2,4,6,8 and 12 mg/kg/min. Infusion will be performed during each of the 4 treatment periods."}],"outcomes":[{"outcome_type":"primary","measure":"beta-cell glucose sensitivity (slope of the relationship between insulin secretion rate and glucose)","time_frame":"0-160 minutes after start of infusion"},{"outcome_type":"secondary","measure":"safety and tolerability of a graded glucose infusion procedure measured by the number of clinical adverse experiences","time_frame":"11 weeks"}]}
{"nct_id":"NCT00917657","start_date":"2008-02-29","phase":"N/A","enrollment":36,"brief_title":"Photorefractive Keratectomy (PRK) for Hyperopia After Radial Keratotomy","official_title":"Corneal Wavefront-Guided PRK With Adjunctive Mitomycin-C for the Treatment of Hyperopia After Radial Keratotomy","primary_completion_date":"2009-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-06-30","last_update":"2009-06-10","description":"To assess the efficacy, predictability, stability and safety of corneal wavefront-guided photorefractive keratectomy (PRK) for correcting hyperopia and astigmatism after radial keratotomy (RK).","other_id":"1183/07","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":30,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Hyperopia or hyperopic astigmatism with spherical equivalent of up to + 9,25 D and\r\n             astigmatism of up to - 4,5 D;\r\n\r\n          -  Uncorrected Visual Acuity of 20/40 or worse;\r\n\r\n          -  Best-Corrected Visual Acuity of 20/60 or better.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Systemic or ocular conditions that could bias results\r\n\r\n          -  Previous photorefractive surgery\r\n      ","sponsor":"University of Sao Paulo","sponsor_type":"Other","conditions":"Hyperopia","interventions":[{"intervention_type":"Procedure","name":"Procedure: Photorefractive keratectomy"}],"outcomes":{}}
{"nct_id":"NCT00800111","start_date":"2008-02-29","phase":"N/A","enrollment":2593,"brief_title":"Study of Endothelial Keratoplasty Outcomes","official_title":"Open-enrollment, Prospective Study of Endothelial Keratoplasty Outcomes","primary_completion_date":"2018-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-02-28","last_update":"2019-01-23","description":"Endothelial keratoplasty is a cornea-sparing transplant technique that replaces only the diseased endothelial cell layer of the patient's cornea. This technique offers many advantages compared with traditional full-thickness cornea transplants. Patients experience minimal change in glasses prescription and usually recover useful vision within weeks. Visual fluctuations are minimal during the healing process. The patient's cornea remains structurally intact and is more resistant to injury. Endothelial keratoplasty is undergoing rapid and widespread adoption. Between 2005 and 2007, the number of corneas placed by US eye banks for endothelial keratoplasty increased ten-fold (2007 Eye Bank Association of America Annual Report). However, the procedure is less than 10 years old, and little is known about long term outcomes. Endothelial keratoplasty candidates at our center are invited to participate in an open enrollment, prospective study of the long-term outcomes of this procedure.","other_id":"CRFA2008-01","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female aged 18 or older\r\n\r\n          -  Scheduled to undergo endothelial keratoplasty\r\n\r\n          -  Able to provide written informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Age less than 18 years\r\n      ","sponsor":"Cornea Research Foundation of America","sponsor_type":"Other","conditions":"Fuchs' Endothelial Corneal Dystrophy|Bullous Keratopathy|Iridocorneal Endothelial Syndrome|Posterior Polymorphous Dystrophy","interventions":[{"intervention_type":"Procedure","name":"Procedure: endothelial keratoplasty","description":"Endothelial keratoplasty is surgical replacement of the corneal endothelial cell layer (the cell layer lining the inner surface of the cornea)."}],"outcomes":[{"outcome_type":"primary","measure":"Visual acuity","time_frame":"1, 3, 6, and 12 months and annually"},{"outcome_type":"secondary","measure":"Endothelial cell density","time_frame":"6 months, 12 months and annually"},{"outcome_type":"secondary","measure":"Intraocular pressure","time_frame":"1, 3, 6, 12 months and annually"},{"outcome_type":"secondary","measure":"Manifest refraction","time_frame":"1, 3, 6, 12 months and annually"},{"outcome_type":"secondary","measure":"corneal pachymetry","time_frame":"1, 3, 6, 12 months and annually"}]}
{"nct_id":"NCT00600015","start_date":"2008-02-29","phase":"Phase 2","enrollment":166,"brief_title":"Sorafenib/Erlotinib Versus Erlotinib Alone in Previously Treated Advanced Non-Small-Cell Lung Cancer (NSCLC)","official_title":"A Randomized Double-Blind Placebo-Controlled Phase II Trial of Sorafenib and Erlotinib or Erlotinib Alone in Previously Treated Advanced Non-Small Cell Lung Cancer","primary_completion_date":"2009-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-02-28","last_update":"2012-09-21","description":"This trial will investigate the use of the newer targeted agents erlotinib and sorafenib in patients with stage IIIB or stage IV NSCLC who have received 1-2 prior chemotherapy regimens. Patients will be randomized to receive erlotinib (150 mg/day) and sorafenib (400 mg twice daily), or erlotinib (150 mg/day) and a placebo.","other_id":"SCRI LUN 160","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically confirmed locally advanced or metastatic NSCLC (unresectable stage IIIB\r\n             or stage IV). Eligible histologies include adenocarcinoma and squamous cell carcinoma.\r\n             Patients with recurrent disease after treatment for localized NSCLC are also eligible.\r\n             Cytologic specimens obtained by brushings, washings, or needle aspiration are\r\n             acceptable.\r\n\r\n          -  At least one lesion that can be accurately measured in at least one dimension (longest\r\n             diameter to be recorded) as >= 20 mm with conventional techniques, or as >= 10 mm with\r\n             spiral computerized tomography (CT) scan according to the Response Evaluation Criteria\r\n             in Solid Tumors (RECIST).\r\n\r\n          -  Failure of at least one, and no more than two prior cytotoxic chemotherapy regimens\r\n             for advanced disease (either due to progressive disease or toxicity).\r\n\r\n          -  Recovery from any toxic effects of prior therapy to <= grade 1.\r\n\r\n          -  Completion of radiation therapy at least 28 days prior to the start of study treatment\r\n             (not including palliative local radiation). Previously irradiated lesions in the\r\n             advanced setting cannot be included as target lesions unless clear tumor progression\r\n             has been observed since the end of radiation.\r\n\r\n          -  An ECOG performance status of 0-2.\r\n\r\n          -  Absolute neutrophil count (ANC) >= 1,500, platelets >= 75,000.\r\n\r\n          -  Hemoglobin >= 9 g/dL (within 7 days prior to study treatment).\r\n\r\n          -  International normalized ratio (INR) <= 1.5 or prothrombin time (PT)/partial\r\n             thromboplastin time (PTT) within normal limits (WNL) of the institution\r\n\r\n          -  Serum creatinine <= 1.5 x institutional upper limit of normal (ULN) within 7 days\r\n             prior to study treatment.\r\n\r\n          -  Transaminases <= 3 x institutional ULN\r\n\r\n          -  Agreement of female patients of childbearing potential and male patients who have\r\n             partners of childbearing potential to use an effective form of contraception to\r\n             prevent pregnancy during treatment, and for a minimum of 90 days thereafter.\r\n\r\n          -  Patients who have treated brain metastases >= 4 weeks out (with surgery and/or\r\n             radiation therapy) and no evidence of CNS progression.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Past or current history of neoplasm (other than the entry diagnosis), with the\r\n             exception of treated non-melanoma skin cancer or carcinoma in-situ of the cervix, or\r\n             other cancers cured by local therapy alone, and a disease-free survival (DFS) >= 3\r\n             years.\r\n\r\n          -  Patients who have mixed tumors with small-cell elements are ineligible.\r\n\r\n          -  Pregnancy or lactation.\r\n\r\n          -  Prior treatment with EGFR TKIs or VEGFR TKIs for NSCLC. [NOTE: prior cetuximab and/or\r\n             bevacizumab use is permitted].\r\n\r\n          -  Significant cardiac disease within 90 days of starting study treatment\r\n\r\n          -  Myocardial infarction within 6 months prior to initiation of study treatment.\r\n\r\n          -  Cardiomegaly on chest imaging or ventricular hypertrophy on electrocardiogram (ECG)\r\n\r\n          -  Poorly controlled hypertension\r\n\r\n          -  Unstable angina (anginal symptoms at rest).\r\n\r\n          -  Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.\r\n\r\n          -  Presence of cardiac disease that, in the opinion of the investigator, increases the\r\n             risk of ventricular arrhythmia.\r\n\r\n          -  A serious underlying medical condition that would impair the ability of the patient to\r\n             receive protocol treatment.\r\n\r\n          -  A major surgical procedure, open biopsy, or significant traumatic injury within 28\r\n             days of beginning treatment, or anticipation of the need for major surgery during the\r\n             course of the study.\r\n\r\n          -  Stroke or transient ischemic attack (TIA) within the past 6 months.\r\n\r\n          -  Any prior history of hypertensive crisis or hypertensive encephalopathy.\r\n\r\n          -  Pulmonary hemorrhage/bleeding event >= grade 2 within 28 days of study treatment.\r\n\r\n          -  Any other non-pulmonary hemorrhage/bleeding event >= grade 3 within 28 days of study\r\n             treatment.\r\n\r\n          -  Evidence or history of bleeding diathesis or coagulopathy.\r\n\r\n          -  Serious non-healing wound, ulcer, or bone fracture.\r\n      ","sponsor":"SCRI Development Innovations, LLC","sponsor_type":"Other","conditions":"Non-Small Cell Lung Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Erlotinib + Sorafenib","description":"Patients who are randomized to Cohort A will take sorafenib 400 mg (2 x 200-mg tablets) orally twice a day, and erlotinib 150 mg orally once a day."},{"intervention_type":"Drug","name":"Drug: Erlotinib + Placebo","description":"Patients who are randomized to Cohort B will take erlotinib 150 mg orally once a day and placebo orally twice a day."}],"outcomes":[{"outcome_type":"primary","measure":"Overall Objective Response Rate (ORR)","time_frame":"18 months"},{"outcome_type":"primary","measure":"Progression Free Survival (PFS)","time_frame":"18 months"},{"outcome_type":"secondary","measure":"Disease Control Rate (DCR)","time_frame":"18 months"},{"outcome_type":"secondary","measure":"Duration of Response","time_frame":"18 months"},{"outcome_type":"secondary","measure":"6-month PFS","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Overall Survival (OS)","time_frame":"18 months"}]}
{"nct_id":"NCT00929825","start_date":"2008-02-29","phase":"Phase 1","enrollment":0,"brief_title":"Therapies for Salivary Flux Stimulation in Patients Transplanted With Hematopoietic Stem Cells","official_title":"Effects of Mechanical and Electrical Sialogogues in Stimulation of the Flow and Biochemical Composition of Saliva in Patients Transplanted With Hematopoietic Stem Cells","primary_completion_date":"2011-06-30","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2011-08-31","last_update":"2016-08-10","description":"The transplantation of hematopoietic stem cells (THSC) is a therapeutic modality developed for the treatment of various diseases such as leukemia, bone marrow aplasia, lymphomas, multiple myeloma, among others. Most patients who undergo the THSC usually have oral manifestations as a result of immunosuppression achieved by chemotherapy and/or radiotherapy. The most common complications are the reduction of salivary flow, mucositis and graft-versus-host disease (GVHD). These conditions can be very debilitating and interfere with medical therapy, leading to systemic complications, affecting the prognosis and increasing the length of hospitalization of the patient and the costs of treatment. To date, there is no protocol that prevents the reduction of salivary flow and minimizes the occurrence of mucositis and GVHD in these patients. This study aims to verify the effectiveness of treatment with two sialogogues (Hyperboloid and TENS [transcutaneous electrical stimulation]) to restore the flow and biochemical composition of saliva in patients undergoing THSC myeloablative and non-myeloablative conditionating regime.","other_id":"0520","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":16,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients submitted to THSC at Clinical Hospital of Federal University who underwent a\r\n             myeloablative or a non-myeloablative conditioning regime\r\n\r\n          -  Age over 16 years\r\n\r\n          -  Oral mucosa intact on the first day of conditioning\r\n\r\n          -  Ability to cooperate with treatment\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Cases with no clinical follow up\r\n\r\n          -  Patients who refuse to participate\r\n\r\n          -  Patients with no ability to cooperate with treatment\r\n      ","sponsor":"Federal University of Minas Gerais","sponsor_type":"Other","conditions":"Mucositis","interventions":[{"intervention_type":"Device","name":"Device: mechanical stimulation (Elastomers)","description":"The instrument of mastication, sialogogue should be used 4 times a day for 10 minutes each time always after meals"},{"intervention_type":"Procedure","name":"Procedure: TENS","description":"transcutaneous electrical stimulation"}],"outcomes":[{"outcome_type":"primary","measure":"Salivary flux","time_frame":"7 days"}]}
{"nct_id":"NCT00598130","start_date":"2008-02-29","phase":"Phase 2","enrollment":30,"brief_title":"Safety and Hemostatic Efficacy of Fibrin Fleece in Partial Nephrectomy","official_title":"A Prospective, Randomized, Single-Blind, Standard Care Controlled, Multi-Center, Phase II Study Evaluating the Safety and Hemostatic Efficacy of Fibrin Fleece in Partial Nephrectomy","primary_completion_date":"2008-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-02-28","last_update":"2009-11-06","description":"This is a prospective, randomized, single blind, standard care- controlled study, which will include a total of 30 patients divided into two treatment arms: First are: patents who will be treated in accordance with standard of care. Second arm: patients for which the Fibrin Fleece will be applied directly on the active bleeding site.","other_id":"FL-PN-002-IS","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients undergoing elective open partial nephrectomy\r\n\r\n          -  Patients must be willing to participate in the study, and provide written informed\r\n             consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with a tumor diameter greater than 4 cm\r\n\r\n          -  Any additional surgical intervention other than partial nephrectomy\r\n\r\n          -  Patients with only one functional kidney\r\n\r\n          -  Patients with known intolerance to blood products or other components of the product\r\n      ","sponsor":"OMRIX Biopharmaceuticals","sponsor_type":"Industry","conditions":"Hemostatic Techniques|Nephrectomy","interventions":[{"intervention_type":"Biological","name":"Biological: Fleece","description":"Fibrin Patch"}],"outcomes":[{"outcome_type":"primary","measure":"Proportion of successes at 10 minutes following randomization","time_frame":"10 minutes"},{"outcome_type":"secondary","measure":"Proportion of successes at 5 minutes following randomization","time_frame":"5 minutes"}]}
{"nct_id":"NCT00605176","start_date":"2008-01-31","phase":"Phase 3","enrollment":479,"brief_title":"Safety and Effectiveness Study of Imiquimod Creams for Treatment of Actinic Keratoses (AKs)","official_title":"A Phase 3, Randomized, Double-blinded, Placebo-controlled, Multicenter, Efficacy and Safety Study of Four Weeks of Treatment With Imiquimod Creams for Actinic Keratoses","primary_completion_date":"2008-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-07-31","last_update":"2010-06-29","description":"The purpose of this study is to determine whether imiquimod creams are effective in treating Actinic Keratoses when applied to the face or balding scalp. Actinic keratosis (AK) is a skin condition that shows up on skin routinely exposed to the sun, such as the face, scalp, shoulders, chest, back, arms, and hands. The active ingredient contained in the study cream for this study is the same as that of the approved product Aldara, which has been shown to be safe and effective for the treatment of AKs.","other_id":"GW01-0702 / 0704","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  In good general health\r\n\r\n          -  Have 5 to 20 AKs on the face or balding scalp\r\n\r\n          -  Negative urine pregnancy test (for women who are able to become pregnant)\r\n\r\n          -  Willing to make frequent visits to the study center during treatment and follow-up\r\n             periods.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Women who are pregnant, lactating or planning to become pregnant during the study.\r\n\r\n          -  Have had a medical event within 90 days of the first visit (such as; stroke, heart\r\n             attack).\r\n\r\n          -  Have any skin condition in the treatment area that may be made worse by treatment with\r\n             imiquimod (e.g., rosacea, psoriasis, atopic dermatitis, eczema).\r\n\r\n          -  Have received specific treatments/medications in the treatment area(s) within the\r\n             designated time period prior to study treatment initiation.\r\n      ","sponsor":"Graceway Pharmaceuticals, LLC","sponsor_type":"Industry","conditions":"Actinic Keratoses","interventions":[{"intervention_type":"Drug","name":"Drug: imiquimod cream","description":"cream, 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment."},{"intervention_type":"Drug","name":"Drug: imiquimod cream","description":"cream, 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"cream, 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment."}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants With Complete Clearance of AK Lesions","time_frame":"End of Study the Week 14 visit","description":"Subject status with respect to complete clearance of AK lesions at End of Study (EOS), ie, the Week 14 visit. Complete clearance was defined as the absence of clinically visible or palpable AK lesions in the treatment area. All lesions within the identified treatment area were included in the count, even if the lesion was a new lesion or 'subclinical' lesion that had not been identified at Baseline."},{"outcome_type":"secondary","measure":"Number of Participants With Partial Clearance of AK Lesions","time_frame":"End of Study the Week 14 visit","description":"Subject status with respect to partial clearance of AK lesions at end of study (EOS), defined as at least a 75% reduction in the number of AK lesions in the treatment area compared with Baseline."},{"outcome_type":"secondary","measure":"Percent Change From Baseline in AK Lesion Count","time_frame":"From baseline to End of Study the Week 14 visit","description":"Percent change from Baseline to end of study (EOS) in investigator counts of AK lesions."},{"outcome_type":"secondary","measure":"Local Skin Reactions","time_frame":"At all visits - from Baseline to End of study (Week 14)","description":"Six local skin reaction (LSR) signs were predefined and were assessed for presence and intensity at each study visit. These included: Erythema, Edema, Weeping/Exudate, Flaking/Scaling/Dryness, Scabbing/Crusting and Erosion/Ulceration. The LSRs were scored as 0=none, 1=mild, 2=moderate, 3=severe. Mean scores were summated over time (14 weeks) to yield a mean LSR AUC (area under the curve)"}]}
{"nct_id":"NCT00670527","start_date":"2008-01-31","phase":"N/A","enrollment":205,"brief_title":"[18F] Fluorocholine FCH Positron Emission Tomography (PET)/Computed Tomography (CT) for Detection of Prostate Cancer Lymph Nodes Metastases","official_title":"Evaluation of [18F] Fluorocholine PET/CT for Detection of Regional Lymph Node Metastases From Prostate Cancer","primary_completion_date":"2013-02-28","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2013-04-30","last_update":"2012-10-08","description":"The objective of this trial is to assess the value of 18F-choline PET/CT for the detection of regional lymph node metastases from prostate cancer. In addition, the investigators want to evaluate whether 18F-choline PET/CT can replace lymphadenectomy for the staging of prostate cancer.","other_id":"PROPET, Project nr. 104.","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"Triple","sampling_method":"","gender":"Male","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with a biopsy confirmed prostate cancer who awaits curative treatment and\r\n             have\r\n\r\n          -  An elevated level of prostate-specific antigen PSA>10 ng/mL (nanogram per milliliter)\r\n             or/and\r\n\r\n          -  A Gleason score > 6 or/and\r\n\r\n          -  A TNM staging of T3\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who withdraw their informed consent.\r\n\r\n          -  Patients who have a bone scan indicates metastatic prostate cancer.\r\n\r\n          -  Patients who have a TNM stage is T4\r\n\r\n        In the case we detect a patient having an obvious other major illness e.g. lung cancer, the\r\n        patient is referred to relevant treatment. Depending on the illness the might be excluded\r\n        from the study.\r\n      ","sponsor":"Odense University Hospital","sponsor_type":"Other","conditions":"Prostate Cancer","interventions":[{"intervention_type":"Procedure","name":"Procedure: [18F] Fluorocholine PET/CT","description":"The patients fast 6 hours before the [18F]Fluorocholine PET/CT scan. [18F]Fluorocholine will be used as tracer with a dosage of 4 MBq per kg bodyweight. PET/CT imaging will be performed after 15 and 60 after the intravenous injection of the tracer. The patient will receive 2 full body FCH PET/CT. The CT scan is with contrast.\r\nThe radiation exposure from the CT scan is 9 mSv and from the PET scan it is 3 mSv, giving a total of 12 mSv, which equals 4 times the yearly background radiation in Denmark."}],"outcomes":[{"outcome_type":"primary","measure":"The primary target variable \"metastasizes to regional lymph nodes\" (yes/no) will be used to estimate the diagnostic usefulness of FCH PET/CT in terms of sensitivity, specificity, positive and negative predictive values.","time_frame":"The [18F] Fluorocholin PET/CT and the lymphadenectomi is done within 1 month"}]}
{"nct_id":"NCT00538200","start_date":"2008-01-31","phase":"N/A","enrollment":85,"brief_title":"Chronic Obstructive Pulmonary Disease (COPD) Nutrition Support Trial","official_title":"A Randomised Trial of Oral Nutritional Supplements Versus Dietary Advice on Clinical Outcomes in Patients With COPD","primary_completion_date":"2011-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-09-30","last_update":"2014-12-08","description":"The purpose of this study is to determine the best form of dietary intervention to undernourished individuals with COPD. The research aims to test the null hypothesis that there is no difference between oral nutritional supplements and dietary advice.","other_id":"ELIA002","allocation":"Randomized","intervention_model":"Parallel Assignment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female\r\n\r\n          -  Age >18 years\r\n\r\n          -  At risk of malnutrition\r\n\r\n          -  Competent to provide written informed consent and able to answer questions\r\n\r\n          -  Able to eat and drink\r\n\r\n          -  Willingness to take part in the trial and to follow the trial protocol\r\n\r\n          -  FEV1 <80% predicted and FEV1/FVC <0.7\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Requirement for tube or parenteral nutrition\r\n\r\n          -  Galactosemia\r\n\r\n          -  Receiving current oral nutritional supplementation\r\n\r\n          -  Palliative care\r\n\r\n          -  Chronic renal disease requiring dialysis\r\n\r\n          -  Liver failure\r\n\r\n          -  Malignancy\r\n\r\n          -  Participation in other studies\r\n\r\n          -  Bronchiectasis\r\n\r\n          -  Those already under the care of a dietitian\r\n      ","sponsor":"University of Southampton","sponsor_type":"Other","conditions":"Malnutrition","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Oral Nutritional Supplements (Fortisip)","description":"These products are classified as non-medicinal, borderline substances, foods for special medical purposes. A range of commercially available liquid oral nutritional supplements (Fortisip) will be offered daily for a 3 month period."},{"intervention_type":"Other","name":"Other: Dietary Advice","description":"Standard dietary advice"}],"outcomes":[{"outcome_type":"primary","measure":"The primary outcome measure is Quality of Life","time_frame":"6 months"}]}
{"nct_id":"NCT00618384","start_date":"2008-01-31","phase":"Phase 2","enrollment":43,"brief_title":"TACE and Sorafenib for Advanced Hepatocellular Carcinoma (HCC)","official_title":"Phase II Study Evaluating Transarterial Chemoembolization (TACE) in Combination With Sorafenib for the Treatment of Advanced Hepatocellular Carcinoma (HCC)","primary_completion_date":"2011-05-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2011-08-31","last_update":"2012-06-07","description":"For patients with advanced HCC not suitable for resection or liver transplantation but without extrahepatic manifestations, local therapy with TACE is regarded as standard treatment. The present study is planned to evaluate the combination of TACE and sorafenib. A combination of TACE with a multitarget inhibitor like sorafenib may further improve the outcome of patients with HCC.","other_id":"SOCRATES-072","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  with histologically confirmed HCC not suitable for resection or liver transplantation\r\n\r\n          -  Patients with measurable disease according to RECIST\r\n\r\n          -  Performance status ECOG 0-2\r\n\r\n          -  Normal organ and bone marrow function (defined)\r\n\r\n          -  Women of childbearing potential must have performed a negative serum pregnancy test\r\n\r\n          -  male or female patients must use an approved contraceptive method during treatment and\r\n             for 3 months after end of treatment after the end of treatment with study medication\r\n\r\n          -  Written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patient is eligible for liver resection or liver transplantation\r\n\r\n          -  Extrahepatic tumor manifestation\r\n\r\n          -  Thrombosis of the portal vein\r\n\r\n          -  > 8 points according to Child Pugh classification\r\n\r\n          -  Prior TACE or RFTA or any other local ablative treatment\r\n\r\n          -  Prior systemic anticancer chemotherapy or radiotherapy for HCC\r\n\r\n          -  Total bilirubin > 4.5 mg/dl\r\n\r\n          -  Life expectancy of less than 12 weeks\r\n\r\n          -  Esophageal varices grade III without prophylactic band ligation\r\n\r\n          -  Cardiac diseases (defined)\r\n\r\n          -  Uncontrolled hypertension\r\n\r\n          -  Known or suspected hyperthyroid state\r\n\r\n          -  Known brain metastasis\r\n\r\n          -  Patients with seizure disorder requiring medication\r\n\r\n          -  History of organ allograft\r\n\r\n          -  Active clinically serious infections > CTCAE grade 2\r\n\r\n          -  Thrombotic or embolic events\r\n\r\n          -  Hemorrhage/bleeding event (defined)\r\n\r\n          -  Acute variceal bleeding\r\n\r\n          -  Therapeutic anticoagulation with vitamin K antagonists (defined)\r\n\r\n          -  Known or suspected allergies to sorafenib, doxorubicin or lipiodol or any agent given\r\n             in the course of this trial\r\n\r\n          -  Contraindications to the use of sorafenib, doxorubicin or lipiodol\r\n\r\n          -  Previous cancer distinct in primary site or histology from HCC (defined)\r\n\r\n          -  substance abuse\r\n\r\n          -  Participation in another clinical trial with any investigational study drug\r\n\r\n          -  Lactating women\r\n\r\n          -  Incapability to give valid informed consent\r\n      ","sponsor":"Heinrich-Heine University, Duesseldorf","sponsor_type":"Other","conditions":"Hepatocellular Carcinoma","interventions":[{"intervention_type":"Drug","name":"Drug: Sorafenib","description":"patients get transarterial chemoembolization (TACE) will get film-coated tablets of Sorafenib (2 x 400 mg/day) until progressive disease"}],"outcomes":[{"outcome_type":"primary","measure":"determination of time to progression (TTP)","time_frame":"every 30 days after administration"},{"outcome_type":"secondary","measure":"adverse events","time_frame":"3-week-periods"}]}
{"nct_id":"NCT01778296","start_date":"2008-01-31","phase":"N/A","enrollment":12,"brief_title":"Repair of Soft Tissue Defect of the Finger Using the Heterodigital Neurocutaneous Island Flap","primary_completion_date":"2012-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-10-31","last_update":"2013-11-18","description":"The dorsum of the finger is a reliable flap donor site in reconstructive hand surgery because of its similar quality to the original. The dorsal digital island flap can be used for repairing the defect of adjacent finger, but the limited length of the pedicle precludes its use for a more distal defect. The heterodigital neurocutaneous island flap of the dorsal branch of the digital nerve can be used as an alternative to resolve this problem.","other_id":"HBTS1301283","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":15,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  the soft tissue defects involving the middle phalanx, the proximal interphalangeal\r\n             joint, or both;\r\n\r\n          -  a defect greater than or equal to 2 cm in length;\r\n\r\n          -  a patient between 15 and 60 years of age.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  concomitant injuries to the dorsal skin of the middle phalanx of adjacent finger that\r\n             precluded its use as donor site;\r\n\r\n          -  injuries to the course of donor nerve branch;\r\n\r\n          -  a defect less than 1.5 cm in length;\r\n\r\n          -  a fingertip or pulp defect;\r\n\r\n          -  a soft tissue defect of the thumb.\r\n      ","sponsor":"The Second Hospital of Tangshan","sponsor_type":"Other","conditions":"Sensory Reconstruction of the Volar Aspect of the Finger|The Heterodigital Neurocutaneous Island Flap","interventions":[{"intervention_type":"Device","name":"Device: the neurocutaneous island flap","description":"The neurocutaneous island flap of the dorsal branch of the digital nerve can be used for repair the defects of the proximal and middle phalanxes of adjacent fingers."}],"outcomes":[{"outcome_type":"primary","measure":"Discriminatory Sensation of the Flap","time_frame":"18 months to 24 months","description":"Discriminatory sensation of the flap is evaluated with the Static 2-point Discrimination Test. The test determines the minimal distance at which a subject can sense the presence of two needles. The modified American Society for Surgery of the Hand guidelines were used to stratify Discriminator measurements (excellent <6 mm; good 6-10 mm; fair 11-15 mm; poor >15 mm. The test point is at the center of the flap. Each area was tested 3 times with a Discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers were considered proof of perception before proceeding to another lower value. We stop at 4mm as a limit of 2PD and considered this normal. These assessments take place at a single time point at the final follow-up."},{"outcome_type":"secondary","measure":"Cold Intolerance","time_frame":"18 months to 24 months","description":"We access the cold intolerance of the injured and donor fingers using the self-administered Cold Intolerance Severity Score questionnaire10 that is rated into mild, moderate, severe, and extreme (0-25, 26-50, 51-75 and 76-100)."}]}
{"nct_id":"NCT00768573","start_date":"2008-01-31","enrollment":4,"brief_title":"Taste Test of a New Formulation of Sildenafil (Revatio)","official_title":"A Single-Blind Study In Healthy Adult Volunteers To Investigate The Palatability Of Different Oral Suspension Formulations Of Revatio","primary_completion_date":"2008-01-31","study_type":"Observational","rec_status":"Completed","completion_date":"2008-01-31","last_update":"2021-02-01","description":"taste of formulation","other_id":"A1481257","observational_model":"Other","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":75,"population":"Healthy volunteers","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of hypersensitivity to test compounds or excipients.\r\n      ","sponsor":"Pfizer's Upjohn has merged with Mylan to form Viatris Inc.","sponsor_type":"Industry","conditions":"None Volunteer","interventions":[{"intervention_type":"Drug","name":"Drug: sildenafil","description":"Oral suspension of sildenafil."}],"outcomes":[{"outcome_type":"primary","measure":"palatability (aroma, flavour texture and mouth feel)","time_frame":"Duration of study."}]}
{"nct_id":"NCT00594139","start_date":"2008-01-31","phase":"Phase 2","enrollment":0,"brief_title":"Autologous Neo-Bladder Construct in Non-Neurogenic Overactive Bladder and Urge Predominant Incontinence","official_title":"An Open Label Multi-center Study of Augmentation Cystoplasty Using an Autologous Neo-Bladder Construct in Subjects With Non-Neurogenic Overactive Bladder and Urge Predominant Incontinence","primary_completion_date":"2008-01-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2008-01-31","last_update":"2018-06-08","description":"Subjects with non-neurogenic over-active bladder will be enrolled. The hypothesis is that augmentation cystoplasty using an autologous neo-bladder construct will increase functional capacity and thereby reduce the number of micturition episodes per day in subjects with non-neurogenic over active bladder and urge predominant incontinence.","other_id":"TNG-CL006","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  History of non-neurogenic overactive bladder for at least 12 months prior to study\r\n             entry\r\n\r\n          -  Intolerance to medical therapy or persistence of symptoms despite medical therapy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subjects with stress incontinence or mixed incontinence where the predominant\r\n             component is stress incontinence\r\n\r\n          -  Use of Botulinum Toxin A injections into the bladder within the previous 6 months\r\n\r\n          -  Presence of a neuromodulator\r\n\r\n          -  Using catheterization as a way to control incontinence\r\n\r\n          -  History of bladder cancer\r\n      ","sponsor":"Tengion","sponsor_type":"Industry","conditions":"Overactive Bladder","interventions":[{"intervention_type":"Biological","name":"Biological: Autologous neobladder construct","description":"provision of an autologous neo-bladder construct"}],"outcomes":[{"outcome_type":"primary","measure":"Mean number of micturitions per day","time_frame":"12 months"},{"outcome_type":"primary","measure":"Overall safety","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Mean voided volumes, mean number of incontinent episodes, mean number of micturitions, cystometric capacity, detrusor pressure, end filling pressure and complaince","time_frame":"periodically within first 12 months as well as during long term follow up out to 5 years"}]}
{"nct_id":"NCT02094144","start_date":"2008-01-31","phase":"N/A","enrollment":126,"brief_title":"Health Benefits of a 6-month Brisk Walking Program in Sedentary Postmenopausal Women","official_title":"Health Benefits of a 6-month Brisk Walking Program in Sedentary Postmenopausal Women : a Randomized Controlled Trial","primary_completion_date":"2010-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-03-31","last_update":"2014-03-21","description":"Community-dwelling women aged 55 or over are recruited at public meetings aimed at promoting physical activity in postmenopausal women. Women are eligible and enrolled in the study if they have no significant disease affecting lower limb function and if they have a sedentary lifestyle. All study participants provide written informed consent to participate to the study. Women are then randomized either to the control group (women have to maintain their lifestyle) or to the exercise group : 40 minutes of brisk walking 3d/wk for 6 months (two supervised sessions and one session performed one their own per week with a detailed program). The intensity of the program is adapted to the heart rate work and gradually increases over the 6-month program. The objective of the study is to determine the health benefits of brisk on walking ability, diet, muscle strength, balance, blood pressure, bone density, body weight, lean and fat mass, depression symptoms, behavioral, emotional responses, sleep quality, and biological indicators of health.","other_id":"8189","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  postmenopausal women aged 55 or older\r\n\r\n          -  women were asked to provide a medical certificate of no contraindication to performing\r\n             the 6MWD.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  rheumatoid arthritis, osteoarthritis, ischemic heart disease, previous joint\r\n             replacement surgery or cerebrovascular disease affecting lower limb function,\r\n             malignant tumors, any pain or medication known to alter physical performance (e.g.,\r\n             corticosteroids, estrogens, statins, or anti-estrogen drugs)\r\n\r\n          -  score value above 9.4 at the Physical Activity Questionnaire for the Elderly\r\n\r\n          -  a 6MWD greater than 105% of the predicted 6MWD based on Troosters' reference equation\r\n      ","sponsor":"University Hospital, Montpellier","sponsor_type":"Other","conditions":"Sedentary Lifestyle|Postmenopausal Women","interventions":[{"intervention_type":"Other","name":"Other: Brisk walking program","description":"The intervention consists on achieve 40 minutes of brisk walking 3d/wk for 6 months (two supervised sessions and one session performed one their own per week with a detailed program). The intensity of the program is adapted to the heart rate work and gradually increases over the 6-month program"},{"intervention_type":"Other","name":"Other: physical activity habit","description":"The Intervention consists on maintain the lifestyle and especially their physical activity habits during 6 months"}],"outcomes":[{"outcome_type":"secondary","measure":"Effect of the brisk walking program on body composition","time_frame":"6 months","description":"Assesment of lean body mass and fat body mass"},{"outcome_type":"secondary","measure":"Effect of the brisk walking program on depression symptoms","time_frame":"6 months","description":"assessment with specific scale"},{"outcome_type":"secondary","measure":"Effect of the brisk walking program on muscle strength","time_frame":"6 months"},{"outcome_type":"primary","measure":"6 minute-walking distance (6MDWS)","time_frame":"6 months","description":"6MWD was performed following ATS guidelines"},{"outcome_type":"secondary","measure":"Effect of the brisk walking program on biological parameters","time_frame":"6 months","description":"measure of PTH, calcitriol (1,25 OHD)"},{"outcome_type":"secondary","measure":"Effect of the brisk walking program on sleep quality","time_frame":"6 months","description":"Assessment with specific scale"}]}
{"nct_id":"NCT01184768","start_date":"2008-01-31","enrollment":3509,"brief_title":"HBA1c and Diagnosis of Type 2 Diabetes","official_title":"HBA1c and Diagnosis of Type 2 Diabetes","primary_completion_date":"2010-10-31","study_type":"Observational","rec_status":"Completed","completion_date":"2010-11-30","last_update":"2011-07-20","description":"Following the 6th Tromso study subjects with HbA1c > 5.7 plus a subsample of subjects with lower hba1c values will be invited to an oral glucose tolerance test to see the predictive value of HBA1c in the diagnosis of type 2 diabetes.","other_id":"UIT-ENDO-2010-2","observational_model":"Cohort","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":20,"maximum_age":80,"population":"random sample of subjects living in Tromso and who participated in the 6 th Troms study","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  participated in the 6 Tromso study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  type 2 diabetes\r\n      ","sponsor":"University of Tromso","sponsor_type":"Other","conditions":"Type 2 Diabetes","interventions":{},"outcomes":[{"outcome_type":"secondary","measure":"Effect of vitamin D status on glucose tolerance","time_frame":"Up to 2 years after participation in the 6th Tromso study"},{"outcome_type":"primary","measure":"Number of subjects with new diagnosis of type 2 diabetes","time_frame":"Up to 2 years after participation in the 6th Tromso study"},{"outcome_type":"secondary","measure":"Number of subjects with new diagnosis of impaired glucose tolerance","time_frame":"Up to 2 years after participation in the 6th Tromso study"},{"outcome_type":"secondary","measure":"Number of subjects with new diagnosis of impaired fasting glucose","time_frame":"Up to 2 years after participation in the 6th Tromso study"}]}
{"nct_id":"NCT01174524","start_date":"2008-01-31","phase":"Phase 4","enrollment":100,"brief_title":"Improvement of Quality of Life in Patients Using Low-dose Pills in the Different Phases of Menacme","official_title":"Improvement of Quality of Life in Patients Using Low-dose Pills in the Different Phases of Menacme","primary_completion_date":"2008-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-11-30","last_update":"2010-08-03","description":"The purpose of this study is to determine whether low-dose contraceptive pills are effective in the improvement of quality of life in patients in the different phases of menacme.","other_id":"MedleyHGF","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":15,"maximum_age":46,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Fertile women with indication of use of contraceptive pills\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Fertile women with any surgical contraceptive method\r\n\r\n          -  Women in menopause\r\n\r\n          -  Diseases the forbidden the use of the drug\r\n      ","sponsor":"Hospital Geral de Fortaleza","sponsor_type":"Other","conditions":"Quality of Life|Menopause|Contraception","interventions":[{"intervention_type":"Drug","name":"Drug: gestoden 60 mcg","description":"gestoden 60 mcg, once a day, administered in 24/4 regimen."},{"intervention_type":"Drug","name":"Drug: ethinylestradiol 15 mcg","description":"ethinylestradiol 15 mcg, once a day, administered in 24/4 regimen"}],"outcomes":[{"outcome_type":"secondary","measure":"Quality of life in differents phases of menacme","time_frame":"eleven months"},{"outcome_type":"primary","measure":"Quality of life","time_frame":"eleven months"}]}
{"nct_id":"NCT00613119","start_date":"2008-01-31","enrollment":108,"brief_title":"PET Evaluation of Brain Peripheral Benzodiazepine Receptors Using [11C]PBR28 in Frontotemporal Dementia","official_title":"PET Evaluation of Brain Peripheral Benzodiazepine Receptors Using [11C]PBR28 in Neurological Disorders","study_type":"Observational","rec_status":"Completed","completion_date":"2017-07-13","last_update":"2019-12-16","description":"This study will use positron emission tomography (PET) imaging to measure a receptor in the brain that is involved in inflammation. Certain neurological disorders, possibly including frontotemporal dementia (FTD), are associated with increased inflammation in the brain. This study may help elucidate the relationship between FTD and inflammation. Patients with FTD and healthy volunteers who are 35 years of age or older may be eligible for this study. Candidates are screened with a medical history, physical examination, electrocardiogram, and blood and urine tests. Participants undergo the following procedures: - Whole body PET scan: PET uses small amounts of a radioactive chemical called a tracer that labels active areas of the brain so the activity can be seen with a special camera. The tracer used in this study is [11C]PBR28. Before starting the scan, a catheter (plastic tube) is placed in a vein in the arm to inject the tracer. Pictures are taken for 1 hour. This short scan is done to determine if [11C]PBR28 binds to the subject s receptors, since a number of people do not have binding. Subjects who have binding continue with brain PET and MRI scans, described below. - Brain PET imaging: Before starting the scan, a catheter is placed in a vein in the arm to inject the tracer,<TAB> and another catheter is placed in an artery in the wrist to obtain blood samples during the scan. The subject lies on the scanner bed. A special mask is fitted to the head and attached to the bed to help keep the person s head still during the scan so the images will be clear. An 8-minute transmission scan is done just before the tracer is injected to provide measures of the brain that are helpful in calculating information from subsequent scans. After the tracer is injected, pictures are taken for about 2.5 hours, while the subject lies still on the scanner bed. - Blood and urine tests are done the day of and the day following each PET scan. - Magnetic resonance imaging (MRI): An MRI scan is done within 1 year (before or after) of the PET scan. This procedure uses a magnetic field and radio waves to produce images of the brain. The subject lies on a table that is moved into the scanner (a tube-like device), wearing earplugs to muffle the noise of the machine during the scanning process. The test takes about 1 hour....","other_id":"080066","time_perspective":"Prospective","sampling_method":"","gender":"All","minimum_age":35,"population":"","criteria":"\n        -  INCLUSION CRITERIA:\r\n\r\n          -  Patients with a diagnosis of Alzheimer disease or frontotemporal dementia (FTD). FTD\r\n             patients with or without motor involvement may be included. FTD patients with either\r\n             the frontal variant (also known as the behavioral variant) or the language variant of\r\n             FTD may be included. AD and FTD patients must either meet capacity criteria to consent\r\n             to research, or be able to assign a surrogate decision-maker who is able to consent to\r\n             research on the subject s behalf.\r\n\r\n          -  TLE patients must have clinically documented partial seizures with consistent EEG\r\n             evidence as defined by the 1981 International Classification of Epileptic Seizures,\r\n             refractory to standard antiepileptic treatment for at least one year. This criterion\r\n             will be established by preliminary screening in the NINDS Clinical Epilepsy Section\r\n             outpatient clinic, and if necessary, inpatient video-EEG monitoring.\r\n\r\n          -  Healthy volunteers.\r\n\r\n        EXCLUSION CRITERIA:\r\n\r\n          -  Current psychiatric disease, substance abuse or severe systemic disease based on\r\n             history and physical exam.\r\n\r\n          -  Laboratory tests with clinically significant abnormalities.\r\n\r\n          -  Prior participation in other research protocols or clinical care in the last year such\r\n             that radiation exposure, including that from this protocol, would exceed the\r\n             guidelines set by the Radiation Safety Committee (RSC).\r\n\r\n          -  Pregnancy or breast feeding.\r\n\r\n          -  Positive result on urine screen for illicit drugs.\r\n\r\n          -  Subjects who cannot lie on their back for extended periods of time.\r\n\r\n          -  History of neurological disease other than FTD or AD or TLE.\r\n\r\n          -  TLE patients:\r\n\r\n               1. with a known treatable seizure etiology such as neoplastic or infectious disease\r\n\r\n               2. with an MRI finding consistent with a brain tumor, trauma or arterial-venous\r\n                  malformations\r\n\r\n               3. with seizure activity within 24 hours prior to the study.\r\n\r\n               4. not capable of giving an informed consent.\r\n\r\n          -  Presence of ferromagnetic metal in the body or heart pacemaker.\r\n      ","sponsor":"National Institute of Mental Health (NIMH)","sponsor_type":"NIH","conditions":"Frontotemporal Lobar Degeneration|Dementia","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Outcome measures will be the amount of [11C]PBR28 binding in the brain in FTD patients and in healthy controls."},{"outcome_type":"secondary","measure":"We will quantify the radioligand's brain uptake, washout, plasma clearance, and distribution volume using compartmental modeling."}]}
{"nct_id":"NCT00743886","start_date":"2008-01-31","phase":"Phase 2/Phase 3","enrollment":50,"brief_title":"Influence of Plasma Rich in Growth Factors (PRGF) on Healing of Medial Collateral Ligament (MCL) Tear","official_title":"Influence of PRGF on Healing of MCL Tear - Randomized-Double-Blind-Placebo Control Trail","primary_completion_date":"2009-02-28","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2009-03-31","last_update":"2011-07-12","description":"To evaluate the influence of Plasma Rich in Growth Factors (PRGF) on the healing process of medial collateral ligament (MCL) tear.","other_id":"5000","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  age 18-40 years old\r\n\r\n          -  diagnosed MCL tear grade 2/3\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  pregnancy\r\n\r\n          -  mental or physical disabilities\r\n      ","sponsor":"Meir Medical Center","sponsor_type":"Other","conditions":"MCL Tear","interventions":[{"intervention_type":"Biological","name":"Biological: Plasma Rich in Growth Factors (PRGF)","description":"injection onto injured area in ligament dose: 3-6mg"},{"intervention_type":"Drug","name":"Drug: saline","description":"injection of 6 cc of saline into injured area"}],"outcomes":[{"outcome_type":"primary","measure":"time and efficiency of healing","time_frame":"1 year"}]}
{"nct_id":"NCT01419158","start_date":"2008-01-31","enrollment":3457,"brief_title":"Prevalence of Alpha-1 Antitrypsin Deficiency in Chronic Obstructive Pulmonary Disease (COPD)","official_title":"Targeted Detection of Alpha-1 Antitrypsin Deficiency in Patients Referred for Pulmonary Function Testing","primary_completion_date":"2010-01-31","study_type":"Observational","rec_status":"Completed","completion_date":"2010-01-31","last_update":"2012-01-19","description":"Alpha-1 antitrypsin deficiency (AATD) is considered a rare genetic cause of chronic obstructive pulmonary disease (COPD) and liver disease. Recent data has suggested that AATD is not as rare as originally thought and undetected AATD may account for COPD in some patients. This study was designed to evaluate the frequency of undetected AATD in a population reporting to academic pulmonary function testing facilities who meet criteria for the diagnosis of COPD. All individuals meeting GOLD criteria for COPD will be consented and offered free testing for AATD. The results will help identify the percent of those with COPD who have undetected AATD.","other_id":"PFT-001","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Individuals reporting for pulmonary function testing who meet criteria for the diagnosis of\r\n        chronic obstructive pulmonary disease","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male and female adults at least 18 years of age able to understand and consent to the\r\n             procedures of this protocol.\r\n\r\n          -  All races and ethnicities will be considered for this study.\r\n\r\n          -  Post-bronchodilator values for pulmonary function tests on the day of enrollment with\r\n             an FEV1 < 80% of predicted and FEV1/FVC < 70% (at least GOLD stage II).\r\n\r\n          -  Subjects who have been tested for Alpha-1 in the past but do not know their genotype\r\n             or phenotype may be included in this study.\r\n\r\n        Note: For the inclusion criteria the investigators will use the patient's GOLD status,\r\n        based on percent predicted (FEV1 < 80% of predicted); however, after sending the absolute\r\n        value of FEV1 to the Data Coordinating Center (DCC) the DCC will calculate the percent\r\n        predicted using a standardized formula (NHANES III). For sites that do not use this\r\n        predicted formula, the results obtained at the DCC may differ from those used for subject\r\n        enrollment. (For example, a subject found to have an FEV1 of <80% at the study site could\r\n        have an FEV1 > 80% when the DCC recalculates it). Enrollment will be based on the percent\r\n        predicted at each study site. If necessary, the data from this small number of outliers\r\n        will be analyzed separately.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subjects in whom post-bronchodilator spirometry is not performed.\r\n\r\n          -  Subjects whose ordering physician has specifically requested that his patients not be\r\n             considered for enrollment.\r\n\r\n          -  Patients who have been tested for Alpha-1 in the past and know their genotype or\r\n             phenotype.\r\n      ","sponsor":"Alpha-1 Foundation","sponsor_type":"Other","conditions":"Alpha-1 Antitrypsin Deficiency|Chronic Obstructive Pulmonary Disease","interventions":{},"outcomes":{}}
{"nct_id":"NCT00646724","start_date":"2008-01-31","phase":"Phase 1/Phase 2","enrollment":30,"brief_title":"Cotransplantation of Islet and Mesenchymal Stem Cell in Type 1 Diabetic Patients","official_title":"Cotransplantation of Islet and Mesenchymal Stem Cell in Type 1 Diabetic Patients","primary_completion_date":"2012-01-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2014-01-31","last_update":"2011-06-16","description":"The study evaluates the safety and efficacy of Cotransplantation of Islet and Mesenchymal Stem Cell in Type 1 Diabetic Patients. The researchers hypothesize that additional Mesenchymal Stem Cell infusion can benefit the promising clinical islet transplantation through the following mechanisms: protection of islet from inflammatory damage, immunological modulation, engraftment promotion, thus decrease or eliminate the need of exogenous insulin and improve -cell function.","other_id":"fuzhough0712","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male and female patients age 18 to 60 years of age\r\n\r\n          -  Ability to provide written informed consent\r\n\r\n          -  Manifest signs and symptoms that are severe enough to be incapacitating\r\n\r\n          -  Patients with poor diabetes control (HbA1c > 7% but < 12%)\r\n\r\n          -  Progressive diabetic complications\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  age < 18 years or > 60 years\r\n\r\n          -  diabetic history < 5 years\r\n\r\n          -  BMI > 27\r\n\r\n          -  body weight > 80 kg\r\n\r\n          -  exogenous insulin requirement > 1 unit/kg/day\r\n\r\n          -  severe anemia (male < 8 g/dl, female < 7 g/dl)\r\n\r\n          -  low white blood cell count (< 3000/dl)\r\n\r\n          -  liver dysfunction\r\n\r\n          -  Active infection including hepatitis B, hepatitis C, HIV, or TB\r\n\r\n          -  panel reactive antibody > 20%\r\n\r\n          -  Any medical condition that, in the opinion of the investigator, will interfere with\r\n             the safe completion of the trial\r\n      ","sponsor":"Fuzhou General Hospital","sponsor_type":"Other","conditions":"Type 1 Diabetes Mellitus","interventions":[{"intervention_type":"Biological","name":"Biological: cotransplantation of islet and mesenchymal stem cell","description":"islet of allograft and MSCs of autograft"}],"outcomes":[{"outcome_type":"primary","measure":"Exogenous insulin requirement","time_frame":"5"},{"outcome_type":"primary","measure":"Hemoglobin A1c","time_frame":"5"},{"outcome_type":"primary","measure":"Glucose and C-peptide levels","time_frame":"5"},{"outcome_type":"secondary","measure":"liver function","time_frame":"5"},{"outcome_type":"secondary","measure":"kidney function","time_frame":"5"},{"outcome_type":"secondary","measure":"Portal vein Ultrasound","time_frame":"1"},{"outcome_type":"secondary","measure":"autoantibodies","time_frame":"5"},{"outcome_type":"secondary","measure":"Complete Blood Count","time_frame":"5"}]}
{"nct_id":"NCT00683644","start_date":"2008-01-31","phase":"Phase 2","enrollment":116,"brief_title":"Zinc to Treat Tinnitus in the Elderly","official_title":"Zinc to Treat Tinnitus in the Elderly: A Randomized Placebo Controlled Crossover Trial.","primary_completion_date":"2011-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-12-31","last_update":"2017-12-13","description":"There is widespread belief and some evidence to indicate that zinc can successfully treat tinnitus. Zinc deficiency is more likely to occur in the elderly . The primary objective of this study is to establish the effectiveness of zinc for the treatment of tinnitus in individuals 60 years of age and older. Subjects will be randomly assigned to either receive zinc daily or a placebo. After 4 months and a 1-month wash-out, the subjects will be crossed over to the other group.","other_id":"200603807","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  60 years of age or older\r\n\r\n          -  Tinnitus for 6 months or more\r\n\r\n          -  Normal copper levels\r\n\r\n          -  Be generally healthy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Have a treatable otological disorder\r\n\r\n          -  Involved in litigation\r\n\r\n          -  Have or are suspected of having a serious psychiatric problem\r\n\r\n          -  Involved in other treatments for tinnitus\r\n\r\n          -  Are taking drugs which might interact with zinc and result in tinnitus\r\n\r\n          -  Have copper deficiency\r\n\r\n          -  Have Zinc levels above normal\r\n\r\n          -  Are cognitively impaired.\r\n      ","sponsor":"University of Iowa","sponsor_type":"Other","conditions":"Tinnitus","interventions":[{"intervention_type":"Drug","name":"Drug: Zinc","description":"Zinc taken once daily"},{"intervention_type":"Drug","name":"Drug: Placebo oral capsule","description":"Placebo capsules taken once daily"}],"outcomes":[{"outcome_type":"primary","measure":"Change From Baseline in Tinnitus Reaction on the Tinnitus Handicap Questionnaire Scores (0-100) at 4 Months","time_frame":"baseline - 4 months","description":"Validated questionnaire of tinnitus reactions. Scale 0 (no tinnitus reaction)- 100 (worst tinnitus reaction). Our primary outcome was the difference scores between Tinnitus Handicap Questionnaire (THQ) on baseline and end of treatment on zinc and placebo treatment. As stated by Newman et al., the test-retest variability was 20%, and difference scores greater than this should be considered a significant reduction. Therefore, changes on the difference scores of 20 or greater were considered as a statistically significant and therefore clinically meaningful improvement for THQ. The minimum score is zero and the maximum is 100. 0 is better and 100 is worse. This applies to all outcome measures."},{"outcome_type":"secondary","measure":"Changes on Baseline Tinnitus Magnitude on Tinnitus Loudness Rating Scores (0-100) at 4 Months Treatment","time_frame":"baseline and 4 months","description":"Participants should rate their tinnitus loudness on a scale of 0 (no perception of tinnitus) to 100 (highest degree of tinnitus perception)."},{"outcome_type":"secondary","measure":"Changes on Baseline Tinnitus Reactions on Tinnitus Annoyance Rating Scores (0-100) at 4 Months Treatment","time_frame":"baseline and 4 months","description":"Tinnitus annoyance rate on a scale of 0 (no annoyance) to 100 (maximum degree of annoyance)"}]}
{"nct_id":"NCT02062047","start_date":"2007-12-31","phase":"Phase 4","enrollment":60,"brief_title":"Full-mouth and Partial-mouth Scaling and Root Planing in Type 2 Diabetic Subjects","official_title":"Full-mouth and Partial-mouth Scaling and Root Planing in Type 2 Diabetic Subjects: Clinical, Immunological and Microbiological Outcomes","primary_completion_date":"2010-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-04-30","last_update":"2014-02-13","description":"The aim of this study will be to evaluate: 1- the effect of full-mouth (FM) scaling and root (SRP) planing in 24 hours associated with or without extensive application of chlorhexidine (CLX) on clinical, microbiological, glycemic and immunological parameters in diabetic subjects with chronic periodontitis at 3, 6 and 12 months post-therapy. The hypothesis is that FMSRP associated with CLX use will provide the best clinical, microbiological, glycemic and immunological outcomes for the treatment of diabetic subjects with periodontitis. Sixty diabetic subjects with chronic periodontitis will be divided in the following therapeutic groups (n=20 subjects per group): FMSRP+CLX group - FMSRP in a maximum of 24 hours, application and irrigation of chlorhexidine 2% gel, rinsing chlorhexidine 0.12% solution during 60 days; FMSRP + placebo group - FMSRP in a maximum of 24 hours, application and irrigation of placebo, rinsing placebo solution during 60 days; Partial-mouth (PM) SRP group: SRP in 4-6 sessions in a maximum of 2 weeks. The following clinical parameters will be evaluated at 3, 6 and 12 months post-therapy: plaque accumulation, gingival bleeding, probing depth, clinical attachment level, bleeding on probing and suppuration. At these same periods, glycated hemoglobin levels will be obtained from all subjects. In addition, six subgingival biofilm samples per subject will be analyzed by checkerboard DNA-DNA hybridization for 40 bacterial species at baseline, 3, 6 and 12 post-therapy. Finally, gingival crevicular fluid samples from two shallow and two deep sites will be evaluated for the levels of cyto/chemokines by ELISA. Data will be submitted to appropriate statistical analysis.","other_id":"SISNEP/277","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":30,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Clinical diagnosis of type 2 diabetes mellitus\r\n\r\n          -  Clinical diagnosis of generalized chronic periodontitis\r\n\r\n          -  > 30 years old\r\n\r\n          -  At least 15 teeth excluding third molars and teeth indicated to exodontia\r\n\r\n          -  More than 30% of the sites with probing depth and clinical attachment level  4 mm at\r\n             baseline\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnancy\r\n\r\n          -  Lactation\r\n\r\n          -  Current smoking\r\n\r\n          -  Smoking within the past 5 years\r\n\r\n          -  Periodontal or/and antibiotic therapies in the previous 6 months\r\n\r\n          -  Regular use of mouthrinses containing antimicrobials in the preceding 2 months\r\n\r\n          -  Other systemic condition that could affect the progression of periodontal disease\r\n\r\n          -  Long-term use of anti-inflammatory and immunosuppressive medications\r\n\r\n          -  Presence of periapical pathology\r\n\r\n          -  Use of orthodontic appliances\r\n\r\n          -  Multiple systemic complications of DM.\r\n      ","sponsor":"University of Guarulhos","sponsor_type":"Other","conditions":"Periodontitis|Diabetes","interventions":[{"intervention_type":"Procedure","name":"Procedure: FMSRP","description":"FMSRP in a maximum of 24 hours."},{"intervention_type":"Drug","name":"Drug: Chlorhexidine","description":"Application and irrigation of chlorhexidine, rinsing chlorhexidine solution during 60 days"},{"intervention_type":"Procedure","name":"Procedure: PMSRP","description":"Scaling and root planing in 4-6 sessions in a maximum of 2 weeks"},{"intervention_type":"Other","name":"Other: Placebo","description":"Application and irrigation of placebo, rinsing placebo solution during 60 days"}],"outcomes":[{"outcome_type":"secondary","measure":"Changes in the levels of IL-23 in gingival crevicular fluid","time_frame":"From baseline to 12 months"},{"outcome_type":"secondary","measure":"Changes in the levels of IL-4 in gingival crevicular fluid","time_frame":"From baseline to 12 months"},{"outcome_type":"secondary","measure":"Changes in levels of receptor activator of NF-κß ligand (RANKL) in gingival crevicular fluid","time_frame":"From baseline to 12 months"},{"outcome_type":"secondary","measure":"Changes in the levels of osteoprotegerin (OPG) in gingival crevicular fluid","time_frame":"From baseline to 12 months"},{"outcome_type":"primary","measure":"Changes in clinical attachment level (CAL) in sites with initial PD ≥7mm from baseline to 12 months.","time_frame":"From baseline to 12 months"},{"outcome_type":"secondary","measure":"Changes in percentage of sites with probing depth ≥5mm","time_frame":"From baseline to 12 months"},{"outcome_type":"secondary","measure":"Changes in serum levels of glycemic hemoglobin","time_frame":"From baseline to 12 months"},{"outcome_type":"secondary","measure":"Changes in the counts of pathogenic bacterial species","time_frame":"From baseline to 12 months"},{"outcome_type":"secondary","measure":"Changes in the levels of tumor necrosis factor-α in gingival crevicular fluid","time_frame":"From baseline to 12 months"},{"outcome_type":"secondary","measure":"Changes in the levels of plaque accumulation","time_frame":"From baseline to 12 months"},{"outcome_type":"secondary","measure":"Changes in the mean percentage of sites with bleeding on probing","time_frame":"From baseline to 12 months"},{"outcome_type":"secondary","measure":"Changes in the full-mouth probing depth","time_frame":"From baseline to 12 months"},{"outcome_type":"secondary","measure":"Changes in the serum levels of fasting plasma glucose","time_frame":"From baseline to 12 months"},{"outcome_type":"secondary","measure":"Changes in the proportions of pathogenic bacterial species","time_frame":"From baseline to 12 months"},{"outcome_type":"secondary","measure":"Changes in the levels of interferon (IFN)-γ in gingival crevicular fluid","time_frame":"From baseline to 12 months"},{"outcome_type":"secondary","measure":"Changes in the levels of interleukin (IL)-17 in gingival crevicular fluid","time_frame":"From baseline to 12 months"}]}
{"nct_id":"NCT02015429","start_date":"2007-12-31","phase":"N/A","enrollment":15,"brief_title":"Effect of Yellow Pea Protein and Fibre Added to a High-carb Meal on Glycemic Response and Food Intake","primary_completion_date":"2008-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-12-31","last_update":"2013-12-19","description":"The investigators hypothesized that consuming isolated yellow pea fibre or protein, alone to together, as part of a high-carbohydrate pasta meal, would reduce the blood glucose response to the meal compared to a meal without yellow pea components and reduce food intake at a meal served 2 hours later.","other_id":"Pea_Fractionation_mixed_meal","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Basic Science","masking_description":"Single","sampling_method":"","gender":"Male","minimum_age":20,"maximum_age":30,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Non-smoking\r\n\r\n          -  No metabolic disease\r\n\r\n          -  BMI 20 - 25 kg/m^2\r\n\r\n          -  male\r\n\r\n          -  age 20-30\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Intolerance to treatments\r\n\r\n          -  on appetite-modifying medications\r\n\r\n          -  restrictive eating\r\n\r\n          -  smoking\r\n\r\n          -  over or underweight\r\n\r\n          -  breakfast-skipping\r\n      ","sponsor":"University of Toronto","sponsor_type":"Other","conditions":"Obesity|Diabetes","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Pasta meal with added fractions or control with no fractions"}],"outcomes":[{"outcome_type":"primary","measure":"Ad libitum food intake at second pizza meal","time_frame":"135 mins after completion of treatment, 20 mins to eat pizza meal.","description":"Food intake measured via electronic scale in g, then converted to kcal using the caloric density."},{"outcome_type":"primary","measure":"Blood glucose","time_frame":"between 0 and 215 mins, every 15-30 mins","description":"Blood glucose measured via hand-held glucometer and finger prick."},{"outcome_type":"secondary","measure":"Subjective appetite","time_frame":"0 to 215 minutes","description":"Measured via Visual Analog Scales (VAS)"},{"outcome_type":"other","measure":"Palatability of treatments","time_frame":"following treatment consumption at 15 mins","description":"Measured by VAS to ensure palatability is not confounding other outcomes."}]}
{"nct_id":"NCT00545948","start_date":"2007-12-31","phase":"Phase 2","enrollment":31,"brief_title":"Adjuvant Cisplatin With Either Genomic-Guided Vinorelbine or Pemetrexed for Early Stage Non-Small-Cell Lung Cancer","official_title":"Phase II Prospective Study Evaluating the Role of Directed Cisplatin Based Chemo With Either Vinorelbine or Pemetrexed for the Adj Tx of Early Stage NSCLC in Patients Using Genomic Expression Profiles of Chemo Sensitivity to Guide Therapy","primary_completion_date":"2012-01-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2012-01-31","last_update":"2014-07-21","description":"This study assigned subjects to either cisplatin/vinorelbine or cisplatin/pemetrexed chemotherapy using a genomic based expression profile to determine chemotherapy sensitivity in completely resected early stage non-squamous non-small-cell lung cancer (NSCLC). The vinorelbine-sensitive tumors group received Vinorelbine followed by cisplatin, while the pemetrexed-sensitive tumors group received pemetrexed followed by cisplatin. The primary objective of this trial was to determine whether genomic-based adjuvant chemotherapy treatment increased the 2-year progression-free survival rate in completely resected patients with NSCLC compared to historic controls. Secondary objectives included: 1) estimation of the percentage of completely resected NSCLC tumors that can be adequately analyzed and used to direct specific adjuvant chemotherapy; 2) estimation of the proportion of patients who are assigned to treatment with vinorelbine and pemetrexed; 3) evaluation of drug sensitivity patterns of cisplatin and pemetrexed in both treatment arms; 4) description of the overall median survival experience of treated patients; and 5) assessment of patient understanding and perceptions of participating in a clinical trial evaluating cancer genomics for adjuvant treatment of early stage lung cancer.","other_id":"Pro00000657","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Patients are eligible to be included in the study only if they meet all of the following\r\n        criteria:\r\n\r\n          1. Patients with completely resected stage IB (> 4 cm), II, or IIIA Non-Squamous NSCLC.\r\n             Patient must be enrolled and begin therapy within 4 to 12 weeks from the date of\r\n             complete surgical resection.\r\n\r\n          2. Fresh tissue must be available for genomics expression profiling.\r\n\r\n          3. ECOG performance status of 0 or 1.\r\n\r\n          4. NO prior chemotherapy, radiation therapy, or biologic/targeted therapy within the last\r\n             5 years. Prior therapy with low dose methotrexate or similar medications is allowed if\r\n             therapy used to treat non-malignant conditions.\r\n\r\n          5. Age  18 years.\r\n\r\n          6. No previous or concomitant malignancy in the past 5 years other than\r\n             curatively-treated carcinoma in situ of the cervix, or basal cell or squamous cell\r\n             carcinoma of the skin.\r\n\r\n          7. No other serious medical or psychiatric illness.\r\n\r\n          8. Signed informed consent.\r\n\r\n          9. Required laboratory data within one week of enrollment:\r\n\r\n               -  ANC or AGC  1500 per uL;\r\n\r\n               -  Platelets  100,000 per uL;\r\n\r\n               -  Total bilirubin  1.5 mg/dL;\r\n\r\n               -  Creatinine  2 mg/dL; creatinine clearance  45 mL/min;\r\n\r\n               -  SGOT/SGPT  1.5x ULN.\r\n\r\n         10. Females of child-bearing potential (not surgically sterilized and between menarche and\r\n             1 year post menopause) must test negative for pregnancy within 7 days prior to or at\r\n             the time of enrollment based on a serum pregnancy test. Both sexually active males and\r\n             females of reproductive potential must agree to use a reliable method of birth\r\n             control, as determined by the patient and their health care team, during the study and\r\n             for 3 months following the last dose of study drug.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Patients will be excluded from the study if they meet any of the following criteria:\r\n\r\n          1. Treatment within the last 30 days with a drug that has not received regulatory\r\n             approval for any indication at the time of study entry.\r\n\r\n          2. Concurrent administration of any other anti-tumor therapy (see #4 inclusion for\r\n             exceptions).\r\n\r\n          3. Inability to comply with protocol or study procedures.\r\n\r\n          4. Active infection requiring IV antibiotics, antifungal or antiviral agents, that in the\r\n             opinion of the investigator would compromise the patient's ability to tolerate\r\n             therapy.\r\n\r\n          5. Major surgery (other than definitive lung cancer surgery) within two weeks of study or\r\n             other serious concomitant systemic disorders that, in the opinion of the investigator,\r\n             would compromise the safety of the patient or compromise the patient's ability to\r\n             complete the study.\r\n\r\n          6. Myocardial infarction having occurred less than 6 months before inclusion, any known\r\n             uncontrolled arrhythmia, symptomatic angina pectoris, active ischemia, or cardiac\r\n             failure not controlled by medications.\r\n\r\n          7. Contraindication to corticosteroids.\r\n\r\n          8. Inability or unwillingness to take folic acid or vitamin B12 supplementation.\r\n\r\n          9. Unwillingness to stop taking herbal supplements while on study.\r\n\r\n         10. Presence of clinically significant third-space fluid collections (for example, ascites\r\n             or pleural effusions) that cannot be controlled by drainage or other procedures prior\r\n             to study entry and throughout study enrollment as the distribution of pemetrexed in\r\n             this fluid space is not fully understood.\r\n\r\n         11. Inability to discontinue administration of aspirin at a dose > 1300 mg/day or other\r\n             long acting, non-steroidal anti-inflammatory agents for 2 days before, the day of, and\r\n             2 days after the dose of pemetrexed (5 days prior for long-acting agents such as\r\n             piroxicam). Moderate dose ibuprofen may be continued.\r\n\r\n         12. Female patients that are pregnant or breast-feeding.\r\n      ","sponsor":"Duke University","sponsor_type":"Other","conditions":"Carcinoma, Non-Small-Cell Lung","interventions":[{"intervention_type":"Drug","name":"Drug: Vinorelbine followed by Cisplatin","description":"Vinorelbine 25 mg/m2 IV over 6-10 minutes on days 1 and 8, followed by Cisplatin 75 mg/m2 IV over 60 minutes on day 1 (every 21 days x 4 cycles)."},{"intervention_type":"Drug","name":"Drug: Pemetrexed followed by Cisplatin","description":"Pemetrexed 500 mg/m2 IV infusion over approximately 10 minutes on day 1, followed by Cisplatin 75 mg/m2 IV over 60 min on day 1 (every 21 days x 4 cycles)"}],"outcomes":[{"outcome_type":"primary","measure":"2-Year Progression-Free Survival Rate in Patients With Completely Resected Stage IB, II, or IIIA NSCLC","time_frame":"2 years","description":"Progression-free survival time was defined as the time from initiation of study treatment to the first date of disease progression or death as a result of any cause. Progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time was censored at the date of the last follow-up visit for patients who were still alive and have not progressed. The two-year progression free survival rate is a percentage, representing the fraction of treated patients who, after two years, are disease free or alive."},{"outcome_type":"secondary","measure":"Percentage of Patients With Completely Resected NSCLC Tumors That Can Be Analyzed and Used to Direct Adjuvant Chemotherapy","time_frame":"4 years","description":"The percentage of patients with completely resected NSCLC tumors who had successful genomic analysis and assigned to treatment among patients. All 31 patients enrolled in the study had completely resected tumors. These tumors included a mixture of squamous and non-squamous histologies as indicated the original protocol. However, an amendment dated January 25, 2010 limited eligibility to patients with non-squamous disease. Given that only 5 patients were accrued into the study after this amendment, results reported will consider all histologies."},{"outcome_type":"secondary","measure":"2-Year Overall Survival in Patients Treated for NSCLC","time_frame":"2 years","description":"Overall survival time was defined as the time from initiation of study treatment to the date of death as a result of any cause. Time was censored at the date of the last follow-up visit for patients who were still alive. The two-year overall survival rate is a percentage, representing the fraction of treated patients who, after two years, are alive"},{"outcome_type":"secondary","measure":"Patient Understanding and Perceptions of Participating in a Clinical Trial Evaluating Cancer Genomics for Adjuvant Treatment of Early Stage Lung Cancer","time_frame":"Baseline","description":"Do to space limitations, see the Detailed Description in the study protocol for the wording of the questions used in the Patient Expectations Questionnaire."},{"outcome_type":"secondary","measure":"Compare Drug Sensitivity Patterns of Cisplatin and Pemetrexed in Both Treatment Arms","time_frame":"2 years","description":"Using genomics-based prediction models previously developed separately for cisplatin and pemetrexed, the probability that each patient was sensitive or would respond to treatment was computed. Quartiles describe the patterns of drug sensitivity probabilities. The 1st, 2nd, and 3rd quartiles are the sensitivity levels at which 25%, 50%, and 75% of patients have lower sensitivity. There is lack of integrity regarding the available data due to irreproducible genomic signatures. Therefore the results of this outcome are not presented."}]}
{"nct_id":"NCT00622232","start_date":"2007-12-31","phase":"Phase 2","enrollment":40,"brief_title":"A Rollover Study for Subjects Who Completed Participation in the VRX496-USA-05-002 Trial","official_title":"A Rollover Study to Evaluate Safety and Therapeutic Effect of Re-infusing Subjects Who Completed Participation in the VRX496-USA-05-002 Trial With Autologous T Cells Transduced With VRX496","primary_completion_date":"2009-01-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2023-06-30","last_update":"2011-06-08","description":"The objective of this study is to determine the long term safety and tolerability of an additional infusion of 10 billion VRX496 gene-modified CD4 T cells with a focus on evaluating additional therapeutic benefits with respect to viral load and CD4 counts.","other_id":"VRX496-USA-05-002-Rollover","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Ability and willingness to give written informed consent in accordance with\r\n             institutional and federal guidelines and to comply with the investigational nature of\r\n             the study and the related requirements.\r\n\r\n          -  Subjects who have successfully completed participation in the VRX496-USA-05-002 trial.\r\n\r\n          -  Subjects who initiated or changed to a new ARV regimen more than 3 months prior to\r\n             Entry Assessment are eligible.\r\n\r\n          -  Subjects that who (1) if on ARVs and are willing to continue on the current therapy\r\n             unchanged, or (2) if not on ARV willing to remain off ARVs for the duration of the\r\n             trial i.e. 9 months. However, if there is clinical need to start or change ARV\r\n             therapy, then it is permitted to do so.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  CD4 counts decreased by 25% from baseline in main study.\r\n\r\n          -  Viral load increased by  1.0 log from baseline in main study or  200,000.\r\n\r\n          -  Female subjects who are of reproductive potential who have a positive serum B HCG at\r\n             the Entry Assessment visit or are not willing to use a reliable method of barrier\r\n             contraception.\r\n\r\n          -  Are breast-feeding.\r\n\r\n          -  Subjects who are actively using injection drugs or other substance abuse (such as\r\n             extensive alcohol or narcotic use).\r\n\r\n          -  Any medical condition(s) which, in the opinion of the investigator, would interfere\r\n             with the subject's ability to participate in or adhere to the requirements of this\r\n             protocol\r\n\r\n          -  Active HIV-related or non HIV-related illness\r\n\r\n          -  Subjects who do not have additional cell product available\r\n      ","sponsor":"VIRxSYS Corporation","sponsor_type":"Industry","conditions":"HIV Infections","interventions":[{"intervention_type":"Genetic","name":"Genetic: VRX496-transduced autologous CD4 T cells","description":"The cell dose will consist of approximately 10 billion VRX496-transduced autologous CD4 T cells provided as a single bolus infusion."}],"outcomes":[{"outcome_type":"primary","measure":"To evaluate the safety and tolerability of an additional infusion of VRX496 CD4+ T cells in subjects who previously received VRX496 CD4 T cells under protocol VRX496-USA-05-002.","time_frame":"9 months"},{"outcome_type":"primary","measure":"To evaluate the change in log10 HIV-1 RNA level","time_frame":"9 months"},{"outcome_type":"primary","measure":"To evaluate the change between main study baseline CD4 counts and Month 9 post reinfusion","time_frame":"9 months"},{"outcome_type":"secondary","measure":"Changes in immune function as determined by ICS and TCR vβ Repertoire profile.","time_frame":"9 months"}]}
{"nct_id":"NCT00533897","start_date":"2007-11-30","phase":"Phase 3","enrollment":270,"brief_title":"Phase IIIB Subcutaneous Missed Dose Study","official_title":"A Phase IIIb, Multi-Center, Randomized, Withdrawal Study to Evaluate the Immunogenicity and Safety of Subcutaneous Administered Abatacept in Adults With Active Rheumatoid Arthritis","primary_completion_date":"2008-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-02-28","last_update":"2015-04-23","description":"The purpose of the study is to determine whether subcutaneous abatacept administered to patients with rheumatoid arthritis is associated with increased immunogenicity or increased safety events upon withdrawal and reintroduction.","other_id":"IM101-167","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Clinical diagnosis of Rheumatoid Arthritis\r\n\r\n          -  Disease Activity Score (DAS)28-C-Reactive Protein (CRP) score  3.2 and 5.1\r\n\r\n          -  On background methotrexate at least 3 months (10mg weekly)\r\n\r\n          -  Must be able to self injection or allow a care giver to do it for them\r\n\r\n          -  Discontinue all Biologics and Disease-Modifying Anti-rheumatic Drugs (DMARDs) except\r\n             for methotrexate\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Participants who had prior exposure to abatacept or CTLA-4 Ig\r\n\r\n          -  Received treatment with rituximab.\r\n\r\n          -  Participants who have received treatment with leflunomide within 1 year of screening\r\n\r\n          -  Participants who have received treatment with immunoadsorption columns (such as\r\n             Prosorba columns), mycophenolate mofetil (Cellcept), cyclosporine A or other\r\n             calcineurin inhibitors, or D-Penicillamine.\r\n      ","sponsor":"Bristol-Myers Squibb","sponsor_type":"Industry","conditions":"Rheumatoid Arthritis","interventions":[{"intervention_type":"Drug","name":"Drug: Abatacept","description":"Solution in pre-filled syringes, Subcutaneously, 125 mg, Weekly, (Short Term (3 periods - 12 weeks each; Long Term)"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Solution in pre-filled syringes, Subcutaneously, 0 mg, Weekly, Period II 12 weeks (Short Term)"}],"outcomes":[{"outcome_type":"primary","measure":"Double-blind Withdrawal (DBW) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Antibody Responses by Enzyme-Linked Immunosorbent Assay (ELISA) at Day 169","time_frame":"Day 169","description":"Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using an enzyme-linked immunosorbent assay (ELISA). Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody."},{"outcome_type":"primary","measure":"Re-introduction (RI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Day 253, by DBW Period Groups","time_frame":"Day 253 (short term)","description":"Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody."},{"outcome_type":"secondary","measure":"RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Day 253, by DBW Period Placebo Group","time_frame":"Day 253 (short term)","description":"Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody."},{"outcome_type":"secondary","measure":"Lead-in (LI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time","time_frame":"For on-treatment visits: Day 1-Day 85, includes ≤21 Days after last dose or up to 1st dose of DBW Period. For follow-up post visits for participants who discontinued drug in LI: Day 22 after last dose of drug to Day 85 after last dose of drug","description":"Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody."},{"outcome_type":"secondary","measure":"LI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by Electrochemiluminescence (ECL) Over Time","time_frame":"For on-treatment visits: Day 1-Day 85, includes ≤21 Days after last dose or up to 1st dose of DBW Period. For follow-up post visits for participants who discontinued drug in LI: Day 22 after last dose of drug to Day 85 after last dose of drug","description":"ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNC) Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing or negative."},{"outcome_type":"secondary","measure":"DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time","time_frame":"Days 86-169, includes ≤21 Days after last dose or up to 1st dose of RI Period","description":"Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody. Samples were obtained during treatment (TRT) visits."},{"outcome_type":"secondary","measure":"DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Post Visits","time_frame":"Day 22 after last dose of drug to Day 85 after last dose of drug","description":"Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody."},{"outcome_type":"secondary","measure":"DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ECL Over Time","time_frame":"Days 86-169, includes ≤21 Days after last dose or up to 1st dose of RI Period","description":"ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNC) Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing or negative."},{"outcome_type":"secondary","measure":"DBW Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ECL At Post Visits","time_frame":"Day 22 after last dose of drug to Day 85 after last dose of drug","description":"ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNC) Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing or negative."},{"outcome_type":"secondary","measure":"RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA Over Time by DBW Treatment Group","time_frame":"For on-treatment visits: Days 170-253, includes ≤21 Days after last dose or up to 1st dose of LTE Period. For follow-up post visits for participants who discontinued drug in RI: Day 22 after last dose of drug to Day 85 after last dose of drug","description":"Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody."},{"outcome_type":"secondary","measure":"DBW Period; Percentage of Participants With Rheumatoid Arthritis (RA) Flare Over Time","time_frame":"Days 85, 113, 141, and 169","description":"A participant had an RA flare if at least 2 of the following criteria were met:\r\nDoubling of tender and swollen joint count from Day 78\r\nIncrease in DAS28-CRP score ≥ 1.2 from Day 78\r\nPrematurely discontinued from Double-blind Withdrawal Period (Period 2) and continued to Re-introduction Period (Period 3)"},{"outcome_type":"secondary","measure":"RI Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ECL Over Time by DBW Treatment Group","time_frame":"For on-treatment visits: Days 170-253, includes ≤21 Days after last dose or up to 1st dose of LTE Period. For follow-up post visits for participants who discontinued drug in RI: Day 22 after last dose of drug to Day 85 after last dose of drug","description":"ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNC) Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing or negative."},{"outcome_type":"secondary","measure":"Short Term (ST); Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 ELISA Antibody Responses by DBW Treatment Groups","time_frame":"For on-TRT visits: Days 1-253 (ST). For follow-up post visits for participants who discontinued drug in the ST: Day 22 after last dose of ST drug to Day 85 after last dose of ST drug","description":"Serum samples from Abatacept-treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody. ST was defined as the LI Period, the DBW Period, and the RI Period (Days 1-253)."},{"outcome_type":"secondary","measure":"Short Term: Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 ECL Antibody Responses by DBW Treatment Groups","time_frame":"For on-TRT visits: Days 1-253 (ST). For follow-up post visits for participants who discontinued drug in the ST: Day 22 after last dose of ST drug to Day 85 after last dose of ST drug","description":"ECL screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNC) Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing or negative."},{"outcome_type":"secondary","measure":"Short Term: Mean Change in Disease Activity Score (DAS) 28 (Using C-Reactive Protein [CRP]) From Baseline Over Time by DBW Treatment Groups","time_frame":"Days 1 (Baseline),15, 29, 57, 78, 85, 113, 141, 169, 197, 225, and 253 (short term)","description":"The DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline."},{"outcome_type":"secondary","measure":"Short Term: Percentage of Participants Achieving Clinically Meaningful Improvement (CMI) in DAS 28 (CRP), Low Disease Activity (LDAS), or Clinical Remission Over Time by DBW Treatment Groups","time_frame":"Days 85, 169, and 253 (short term)","description":"DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline."},{"outcome_type":"secondary","measure":"Short Term; Mean Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline Over Time by DBW Treatment Groups","time_frame":"Days 1 (Baseline),15, 29, 57, 78, 85, 113, 141, 169, 197, 225, and 253 (short term)","description":"The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index."},{"outcome_type":"secondary","measure":"Short Term; Percentage of Participants With HAQ-DI Response Over Time by DBW Treatment Groups","time_frame":"Days 1 (Baseline),15, 29, 57, 78, 85, 113, 141, 169, 197, 225, and 253 (short term)","description":"The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index."},{"outcome_type":"secondary","measure":"LI; Mean Change in DAS 28 (CRP) From Baseline Over Time","time_frame":"Days 1 (Baseline), 15, 29, 57, 78, 85","description":"DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline."},{"outcome_type":"secondary","measure":"LI; Percentage of Participants With Clinically Meaningful Improvement in DAS (CRP) Over Time","time_frame":"Days 15, 29, 57, 78, 85","description":"DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline."},{"outcome_type":"secondary","measure":"DBW Period; Mean Change in DAS 28 (CRP) From DBW Period Baseline (Day 85) Over Time","time_frame":"Days 85 (Period 2 Baseline), 113, 141, and 169","description":"DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline."},{"outcome_type":"secondary","measure":"RI Period; Mean Change in DAS 28 (CRP) From RI Period Baseline (Day 169) Over Time","time_frame":"Days 169 (Period III Baseline), 197, 225, and 253","description":"DAS28 is a continuous disease measure composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, the level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. DAS28 has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Clinically meaningful improvement= decrease in DAS28 score of ≥1.2 from baseline."},{"outcome_type":"secondary","measure":"LI; Number of Participants With Deaths, Serious Adverse Events (SAEs), SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, or AEs Leading to Discontinuation","time_frame":"From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier","description":"AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event."},{"outcome_type":"secondary","measure":"LI Period; Number of Participants With AEs of Special Interest","time_frame":"From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier","description":"AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections and opportunistic infections; autoimmune disorders; malignancies; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion), peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion),local injection site reaction (pre-specified AEs occurring at the site of SC injection)and systemic injection site reactions (pre-specified systemic AEs such as hypersensitivity reactions occurring within 24 hours of SC injection)"},{"outcome_type":"secondary","measure":"LI; Number of Participants With Hematology Values Meeting the Marked Abnormality (MA) Criteria","time_frame":"From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier","description":"Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 cells/ microliter (uL); eosinophils: >0.750 * 10^3 cells/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 cells/uL/ >7.50 * 10^3 cells/uL."},{"outcome_type":"secondary","measure":"LI; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria","time_frame":"From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier","description":"Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL"},{"outcome_type":"secondary","measure":"LI; Number of Participants With Electrolyte Values Meeting the Marked Abnormality Criteria","time_frame":"From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier","description":"Marked abnormality criteria: Sodium (Na): <0.95*LLN/ >1.05*ULN, or if BL<LLN then use <0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; (Cl): <0.9* LLN/>1.1* ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use <0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN"},{"outcome_type":"secondary","measure":"LI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria","time_frame":"From Day 1 through Day 85, up to 56 days post last dose in Lead-in Period or up to first dose in next period, whichever occurred earlier","description":"MA criteria: serum glucose (Glu): <65 mg/dL/>220 mg/dL;fasting serum Glu: <0.8* LLN/>1.5*upper limits of normal (ULN),or if BL< lower limits of normal (LLN) then use 0.8*BL or > upper limits of normal (ULN),or if BL>ULN then use >2.0*BL or <LLN;total protein: <0.9*LLN/>1.1*ULN,or if BL<LLN then use <0.9*BL or >ULN,or if BL>UNL then use >1.1*BL or <LLN; albumin: <0.9*LLN,or if BL<LLN then use <0.75 BL;uric acid: >1.5*ULN,or if BL>ULN then use >2*BL. Urinalysis: Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells (RBCs), White Blood Cells (WBCs):Use ≥2 when BL value missing or when pre-dose=0 or 0.5; use ≥3 when pre-dose=1, use ≥4 when pre-dose=2 or 3"},{"outcome_type":"secondary","measure":"LI Period; Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)","time_frame":"Days 1, 15, 29, 57, 78, and 85","description":"Blood pressure was taken in participants while seated and measured in millimeters of mercury (mmHg). Pressures were assessed at screening, at baseline on Day 1 prior to infusion of IV abatacept, at 30 and 60 minutes after IV infusion of abatacept on Day 1, and at all office visits prior to SC injection of abatacept. Vital signs were also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely."},{"outcome_type":"secondary","measure":"LI Period; Mean Heart Rate (HR)","time_frame":"Days 1, 15, 29, 57, 78, and 85","description":"Heart rate was taken in participants while seated and measured in beats per minute (bpm). Heart rate was assessed at screening, at baseline on Day 1 prior to infusion of IV abatacept, at 30 and 60 minutes after IV infusion of abatacept on Day 1, and at all office visits prior to SC injection of abatacept. Heart rate was also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely."},{"outcome_type":"secondary","measure":"LI Period; Mean Temperature (T)","time_frame":"Days 1, 15, 29, 57, 78, and 85","description":"Temperature was taken in participants while seated and measured in degrees celsius. Temperature was assessed at screening, at baseline on Day 1 prior to infusion of IV abatacept, at 30 and 60 minutes after IV infusion of abatacept on Day 1, and at all office visits prior to SC injection of abatacept. Temperature was also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely."},{"outcome_type":"secondary","measure":"DBW; Number of Participants With Death, Serious SAEs, Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation","time_frame":"From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier","description":"AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event."},{"outcome_type":"secondary","measure":"DBW; Number of Participants With AEs of Special Interest","time_frame":"From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier","description":"AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections and opportunistic infections; autoimmune disorders; malignancies; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion), peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion),local injection site reaction (pre-specified AEs occurring at the site of SC injection)and systemic injection site reactions (pre-specified systemic AEs such as hypersensitivity reactions occurring within 24 hours of SC injection)"},{"outcome_type":"secondary","measure":"DBW; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria","time_frame":"From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier","description":"Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 cells/uL; eosinophils: >0.750 * 10^3 cells/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 cells/uL/ >7.50 * 10^3 cells/uL."},{"outcome_type":"secondary","measure":"DBW; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria","time_frame":"From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier","description":"Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL"},{"outcome_type":"secondary","measure":"DBW; Number of Participants With Electrolytes Values Meeting the Marked Abnormality Criteria","time_frame":"From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier","description":"Marked abnormality criteria: Sodium (Na): <0.95*LLN/ >1.05*ULN, or if BL<LLN then use <0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; (Cl): <0.9* LLN/>1.1* ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use <0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN"},{"outcome_type":"secondary","measure":"DBW; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria","time_frame":"From Day 85 through Day 169, up to 56 days post last dose in DBW Period or up to first dose in RI Period, whichever occurred earlier","description":"MA criteria: serum glucose (Glu): <65 mg/dL/>220 mg/dL;fasting serum Glu: <0.8* LLN/>1.5*ULN,or if BL<LLN then use 0.8*BL or >ULN,or if BL>ULN then use >2.0*BL or <LLN;total protein: <0.9*LLN/>1.1*ULN,or if BL<LLN then use <0.9*BL or >UNL,or if BL>UNL then use >1.1*BL or <LLN; albumin: <0.9*LLN,or if BL<LLN then use <0.75 BL;uric acid: >1.5*ULN,or if BL>ULN then use >2*BL. Urinalysis (Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or when pre-dose=0 or 0.5; use ≥3 when pre-dose=1, use ≥4 when pre-dose=2 or 3"},{"outcome_type":"secondary","measure":"DBW; Mean Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During Double Blind Period","time_frame":"Days 113, 141, and 169","description":"Blood pressures were taken in participants while seated, just prior to study drug injection, and measured in millimeters of mercury (mmHg)."},{"outcome_type":"secondary","measure":"DBW Period; Mean Heart Rate (HR) During Period 2","time_frame":"Days 113, 141, and 169","description":"Heart Rate was taken in participants while seated, just prior to study drug injection, and measured in beats per minute (bpm)"},{"outcome_type":"secondary","measure":"DBW Period; Mean Temperature (T) During Period II","time_frame":"Days 113, 141, and 169","description":"Participants were seated and temperature taken just prior to study drug injection."},{"outcome_type":"secondary","measure":"RI; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation","time_frame":"From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier.","description":"AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event."},{"outcome_type":"secondary","measure":"RI; Number of Participants With AEs of Special Interest","time_frame":"From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier.","description":"AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections and opportunistic infections; autoimmune disorders; malignancies; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion), peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion),local injection site reaction (pre-specified AEs occurring at the site of SC injection)and systemic injection site reactions (pre-specified systemic AEs such as hypersensitivity reactions occurring within 24 hours of SC injection)"},{"outcome_type":"secondary","measure":"RI; Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria","time_frame":"From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier.","description":"Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 cells/uL; eosinophils: >0.750 * 10^3 cells/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 cells/uL/ >7.50 * 10^3 cells/uL."},{"outcome_type":"secondary","measure":"RI; Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria","time_frame":"From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier.","description":"Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL"},{"outcome_type":"secondary","measure":"RI; Number of Participants With Electrolytes Values Meeting the Marked Abnormality Criteria","time_frame":"From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier.","description":"Marked abnormality criteria: Sodium (Na): <0.95*LLN/ >1.05*ULN, or if BL<LLN then use <0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; (Cl): <0.9* LLN/>1.1* ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use <0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN"},{"outcome_type":"secondary","measure":"RI; Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria","time_frame":"From Day 169 through Day 253, up to 56 days post last dose in RI Period or up to first dose in LTE, whichever occurred earlier.","description":"MA criteria: serum glucose (Glu): <65 mg/dL/>220 mg/dL;fasting serum Glu: <0.8* LLN/>1.5*ULN,or if BL<LLN then use 0.8*BL or >ULN,or if BL>ULN then use >2.0*BL or <LLN;total protein: <0.9*LLN/>1.1*ULN,or if BL<LLN then use <0.9*BL or >UNL,or if BL>UNL then use >1.1*BL or <LLN; albumin: <0.9*LLN,or if BL<LLN then use <0.75 BL;uric acid: >1.5*ULN,or if BL>ULN then use >2*BL. Urinalysis (Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or when pre-dose=0 or 0.5; use ≥3 when pre-dose=1, use ≥4 when pre-dose=2 or 3"},{"outcome_type":"secondary","measure":"RI Period; Mean Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During Period III","time_frame":"Days 169, 197, 225, and 253"},{"outcome_type":"secondary","measure":"RI Period; Mean Heart Rate (HR) During Period III","time_frame":"Days 169, 197, 225, and 253"},{"outcome_type":"secondary","measure":"RI Period; Mean Temperature (T) During Period III","time_frame":"Days 169, 197, 225, and 253"},{"outcome_type":"secondary","measure":"Short Term; Abatacept Serum Concentration by Immunogenicity Status as Measured by ELISA by RI Treatment Groups","time_frame":"Day 197 through Day 253","description":"Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmin=minimum observed plasma concentration of single-dose abatacept. Cmin for each participant was listed by study visit and immunogenicity status (seropositive vs. seronegative) was determined by ELISA."},{"outcome_type":"secondary","measure":"Short Term; Abatacept Serum Concentration by Immunogenicity Status as Measured by ECL by RI Treatment Groups","time_frame":"Day 197 through Day 253","description":"Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmin=minimum observed plasma concentration of single-dose abatacept. Cmin for each participant was listed by study visit and immunogenicity status (seropositive vs. seronegative) was determined by ECL."},{"outcome_type":"secondary","measure":"ST; Number of Participants Positive for Anti-nuclear Antibody (ANA), Anti-double Stranded DNA Antibody (dsDNA), or Rheumatoid Factor (RF) at Day 253 According to Baseline Status (Negative at Baseline or Positive at Baseline) by DBW Treatment Groups","time_frame":"Baseline, Day 253","description":"Venous blood was collected and tested for anti-nuclear antibodies, anti-dsDNA antibodies, and rheumatoid factor. ANA were detected by means of immunofluorescent antibodies. An anti-DNA radioimmunoassay was used for detection of anti-dsDNA antibodies (Diagnostic Products Corporation). RF was measured by an immunoturbidimetric assay (Roche Tina-Quant). Determinations of antibody or RF status were made at baseline and Day 253."},{"outcome_type":"secondary","measure":"LTE: DAS28-CRP Mean Change From Baseline (Day 1) Over Time - All Participants Treated in LTE","time_frame":"For Period 1 non-responders: as of Study Day 85 and up to Day 1821. For ST completers: as of Study Day 253 and up to Day 1821.","description":"DAS28=continuous disease measure composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28, level of serum reactant protein CRP, and participant global assessment of disease activity measured on a visual analogue scale. DAS28-CRP has numeric thresholds defining high disease activity (> 5.1), low disease activity (≤ 3.2) and remission (< 2.6). Last day of ST is Day 85 for Period I Nonresponders and Day 253 for ST Completers . Data are not available(NA) for the period from Day 113 to Day 253 for Period 1 non-responders. Note: Day 85 and Day 337 assessments for the Period I Nonresponder cohort in fact represent consecutive assessments with an interval of approximately 1 month. For Period I nonresponder, study days do not represent treatment days. Study Day 337 for a Period I nonresponder actually corresponds to that participant's Treatment Day 169."},{"outcome_type":"secondary","measure":"LTE: Percent of Participants Who Achieved Clinical Remission in the Long Term Extension - All Participants Treated in LTE","time_frame":"For Period I non-responders: as of Study Day 85 and up to Study Day 1821. For ST completers: as of Study Day 253 and up to Study Day 1821","description":"DAS28=continuous disease measure composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28, level of serum reactant protein CRP, and participant global assessment of disease activity measured on a visual analogue scale. Clinical remission=DAS28-CRP score<2.6. Percent=Number of participants meeting remission divided by number of participants evaluated. Last day of ST is Day 85 for Period I Nonresponders and Day 253 for ST Completers . Data are not available (NA) for the period from Day 113 to Day 253 for Period 1 non-responders. Note: Day 85 and Day 337 assessments for the Period I Nonresponder cohort in fact represent consecutive assessments with an interval of approximately 1 month. For Period I nonresponder, study days do not represent treatment days. Study Day 337 for a Period I nonresponder actually corresponds to that participant's Treatment Day 169."},{"outcome_type":"secondary","measure":"LTE: Percent of Participants With Low Disease Activity in Long Term Extension: All Participants Treated in LTE","time_frame":"For Period 1 non-responders: as of Study Day 85 and up to Day 1821. For ST completers: as of Study Day 253 and up to Day 1821.","description":"DAS28:continuous disease measure composite of 4 variables: number of tender joints out of 28 joints, number of swollen joints out of 28 joints, level of the serum reactant protein CRP, and participant global assessment of disease activity measure on a visual analogue scale. Low disease activity score: ≤ 3.2. Percent=Number of participants with Low Disease Activity divided by number of participants evaluated. Last day of ST is Day 85 for Period I Nonresponders and Day 253 for ST Completers . Data are not available(NA) for the period from Day 113 to Day 253 for Period 1 non-responders. Note: Day 85 and Day 337 assessments for the Period I Nonresponder cohort in fact represent consecutive assessments with an interval of approximately 1 month. For Period I nonresponder, study days do not represent treatment days. Study Day 337 for a Period I nonresponder actually corresponds to that participant's Treatment Day 169."},{"outcome_type":"secondary","measure":"LTE: Percent of Participants With HAQ Response Over Time - All Participants Treated in LTE","time_frame":"Study Days 1 (Baseline),15, 29, 57, 78, 85, 253, 337, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1345, 1457, 1541,1625,1709,1821,1905,1989, 2073","description":"The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index (DI) was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ DI. Percent=number of participants with HAQ response divided by number of participants in the analysis. Since Period I Non-responders proceeded directly to the LTE at the end of Period I (Day 85), study days do not represent treatment days."},{"outcome_type":"secondary","measure":"LTE: Overall Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses (ECL Method) for On-Treatment Visits, Post Last Dose Visits, and Overall Study - All Participants Treated in LTE","time_frame":"Days 337, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1457, 1625, 1821, 1989 and 28, 56, 85, 168 days post last dose in LTE","description":"Serum samples from Abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using electrochemiluminescence (ECL). The percent of participants with a positive abatacept induced immunogenicity response against cytotoxic T-lymphocyte antigen 4 (CTLA4) and possibly immunoglobulin (Ig), or against Ig and/or Junction Region was calculated by number of participants with a positive response divided by number of participants evaluated. Overall for on-treatment includes treatment visits on Days 337, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1177, 1261, 1457, 1625, 1821, and 1989."},{"outcome_type":"secondary","measure":"LTE: Number of Participants With Death, Related SAEs, SAEs Leading to Discontinuation, Related AEs, or AEs Leading to Discontinuation During Long Term Extension (LTE)","time_frame":"For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014), up to 56 days post last dose. For ST completers: as of Day 253 and up to completion of LTE (FEB 2014) up to 56 days post last dose.","description":"AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. SAEs include hospitalizations for elective surgical procedures.All deaths reported during the LTE including those that occurred > 56 days after the last dose. Related AE or SAE defined as AE or SAE with Certain, Probable, Possible, or Missing relationship to study medication. All participants who completed the ST period could enter the open label LTE on Day 253; LI Period 1 non-responders could directly enter the LTE."},{"outcome_type":"secondary","measure":"LTE: Number of Participants With AEs of Special Interest During LTE","time_frame":"For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014) up to 56 days post last dose. For ST completers: as of Day 253 and up to completion of LTE (FEB 2014) up to 56 days post last dose.","description":"AEs of special interest in LTE are those AEs that may be associated with the use of immunomodulatory drugs, including all infections and opportunistic infections; autoimmune disorders; malignancies, local injection site reaction (pre-specified AEs occurring at the site of SC injection) and systemic injection site reactions (pre-specified systemic AEs such as hypersensitivity reactions occurring within 24 hours of SC injection)"},{"outcome_type":"secondary","measure":"LTE: Number of Participants With Hematology Values Meeting the Marked Abnormality Criteria During LTE","time_frame":"For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014). For ST completers: as of Day 253 and up to completion of LTE (FEB 2014). Data included up to 56 days post last dose.","description":"Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 cells/uL; eosinophils: >0.750 * 10^3 cells/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 cells/uL/ >7.50 * 10^3 cells/uL."},{"outcome_type":"secondary","measure":"LTE: Number of Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria During LTE","time_frame":"For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014). For ST completers: as of Day 253 and up to completion of LTE (FEB 2014). Data included up to 56 days post last dose.","description":"Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL"},{"outcome_type":"secondary","measure":"LTE: Number of Participants With Electrolyte Values Meeting the Marked Abnormality Criteria During LTE","time_frame":"For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014). For ST completers: as of Day 253 and up to completion of LTE (FEB 2014). Data included up to 56 days post last dose.","description":"Marked abnormality criteria: Sodium (Na): <0.95*LLN/ >1.05*ULN, or if BL<LLN then use <0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; (Cl): <0.9* LLN/>1.1* ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use <0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN"},{"outcome_type":"secondary","measure":"LTE: Number of Participants With Other Chemistry and Urinalysis Values Meeting the Marked Abnormality Criteria During LTE","time_frame":"For Period I non-responders: as of Day 85 and up to completion of LTE (FEB 2014). For ST completers: as of Day 253 and up to completion of LTE (FEB 2014). Data included up to 56 days post last dose.","description":"MA criteria: serum glucose (Glu): <65 mg/dL/>220 mg/dL;fasting serum Glu: <0.8* LLN/>1.5*ULN,or if BL<LLN then use 0.8*BL or >ULN,or if BL>ULN then use >2.0*BL or <LLN;total protein: <0.9*LLN/>1.1*ULN,or if BL<LLN then use <0.9*BL or >UNL,or if BL>UNL then use >1.1*BL or <LLN; albumin: <0.9*LLN,or if BL<LLN then use <0.75 BL;uric acid: >1.5*ULN,or if BL>ULN then use >2*BL. Urinalysis (Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or when pre-dose=0 or 0.5; use ≥3 when pre-dose=1, use ≥4 when pre-dose=2 or 3"},{"outcome_type":"secondary","measure":"LTE: Mean Seated Systolic Blood Pressure (SBP) During LTE","time_frame":"Days 337, 365, 449, 533, 617, 729,813, 897,981, 1093, 1177,1261,1345, 1457,1541,1625,1709,1821,1905,1989,2073","description":"During LTE, blood pressure was taken in participants while seated, measured in millimeters of mercury (mmHg) and were assessed at all office visits prior to SC injection of abatacept. Vital signs were also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely."},{"outcome_type":"secondary","measure":"LTE: Mean Seated Diastolic Blood Pressure (DBP) During LTE","time_frame":"Days 337, 365, 449, 533, 617, 729,813, 897,981, 1093, 1177,1261, 1345, 1457,1541,1625,1709,1821,1905,1989,2073","description":"During LTE, blood pressure was taken in participants while seated, measured in millimeters of mercury (mmHg) and were assessed at all office visits prior to SC injection of abatacept. Vital signs were also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely."},{"outcome_type":"secondary","measure":"LTE: Mean Heart Rate (HR) During LTE","time_frame":"Days 337, 365, 449, 533, 617, 729,813, 897,981, 1093, 1177,1261, 1345, 1457,1541,1625,1709,1821,1905,1989,2073","description":"During LTE, heart rate was taken in participants while seated, measured in beats per minute (bpm) and was assessed at all office visits prior to SC injection of abatacept. Heart rate was also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely."},{"outcome_type":"secondary","measure":"LTE: Mean Temperature (T) During LTE","time_frame":"Days 337, 365, 449,533, 617, 729,813, 897,981, 1093, 1177,1261, 1345, 1457,1541,1625,1709,1821,1905,1989,2073","description":"During LTE, temperature was taken in participants while seated, measured in degrees celsius and was assessed at all office visits prior to SC injection of abatacept. Temperature was also assessed 7 days after the last injection of abatacept for participants who were withdrawn prematurely."}]}
{"nct_id":"NCT00573651","start_date":"2007-11-30","phase":"Phase 4","enrollment":43,"brief_title":"Safety and Efficacy of Gardasil in Females With Juvenile Idiopathic Arthritis (JIA)/Seronegative Arthritis","official_title":"Pilot Study of the Safety and Efficacy of Quadrivalent Human Papillomavirus Vaccine (Gardasil) in Female Subjects With Juvenile Idiopathic Arthritis (JIA)/ Seronegative Arthritis","primary_completion_date":"2020-12-11","study_type":"Interventional","rec_status":"Completed","completion_date":"2020-12-11","last_update":"2020-12-17","description":"The purpose of this research study is to see if patients with juvenile idiopathic arthritis or seronegative arthritis (and related conditions) mount protective immune responses to the human papillomavirus (HPV) vaccine called Gardasil. The researchers also want to monitor for any increase in disease activity following receipt of the vaccine.","other_id":"Gardasil in JIA","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Other","masking_description":"Single","intervention_model_description":"Open label vaccination study Gardasil vaccine (4 component).","sampling_method":"","gender":"Female","minimum_age":9,"maximum_age":26,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Female patients, age 9-26 years, with polyarticular JIA, pauciarticular JIA, and\r\n             sero-negative arthritis.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnancy\r\n\r\n          -  Known allergy/sensitivity or any hypersensitivity to yeast or components of study drug\r\n             or their formulation\r\n\r\n          -  Systemic onset JIA with active systemic symptoms (systemic onset JIA with\r\n             polyarticular features but no fever or rash may be included).\r\n\r\n          -  Prior vaccination against HPV\r\n\r\n          -  Known HPV infection\r\n\r\n          -  Current or history of cervical cancer or cervical intraepithelial neoplasia (CIN).\r\n\r\n        Males are excluded from this study because Gardasil is currently approved only for\r\n        females.\r\n      ","sponsor":"University Hospitals Cleveland Medical Center","sponsor_type":"Other","conditions":"Arthritis","interventions":[{"intervention_type":"Other","name":"Other: Blood Draws for Serum Titers","description":"All study subjects are receiving the Gardasil vaccine as part of their clinical care. The Gardasil vaccine is not given because of study participation. The study observes outcomes related to this clinical care. Study intervention consists of some blood samples taken to measure antibody and RNA titers. Other study specific procedures performed include Questionnaires and observational data."}],"outcomes":[{"outcome_type":"primary","measure":"Serum GMTs at 7 months","time_frame":"7 months","description":"dichotomized as negative or positive"},{"outcome_type":"secondary","measure":"Disease flare","time_frame":"2 years","description":"increased arthritis requiring addition of steroids, intensification of NSAIDs or new DMARD or biological DMARD"},{"outcome_type":"secondary","measure":"Peds QL","time_frame":"2 years","description":"worsening of >30% from the prior visit"},{"outcome_type":"secondary","measure":"Measure serum GMT","time_frame":"12 months","description":"dichotomized as negative or positive"},{"outcome_type":"secondary","measure":"Measure serum GMT","time_frame":"24 months"}]}
{"nct_id":"NCT00521794","start_date":"2007-11-30","enrollment":28,"brief_title":"Characteristics of Andersen-Tawil Syndrome","official_title":"Andersen-Tawil Syndrome: Genotype-Phenotype Correlation and Longitudinal Study","primary_completion_date":"2012-10-31","study_type":"Observational","rec_status":"Completed","completion_date":"2012-10-31","last_update":"2013-01-16","description":"Andersen-Tawil Syndrome (ATS) is a rare, genetic disorder that causes episodes of muscle weakness, potentially life-threatening changes in heart rhythm, and developmental abnormalities. Disease symptoms can vary, the cause of some ATS cases remains unknown, and no specific treatment has been identified. The purpose of this multi-site study is to better characterize ATS, establish whether symptoms change over time, and determine if symptoms are related to a mutation in the KCNJ2 gene.","other_id":"RDCRN 5301","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":10,"population":"Individuals with a clinically confirmed diagnosis of Andersen-Tawil Syndrome (ATS) enrolled\r\n        across seven sites in the United States, England, Italy and Canada","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Clinically confirmed diagnosis of ATS as defined by at least two of the following\r\n             three criteria:\r\n\r\n               1. Presence of clear-cut episodes of transient muscle weakness with or without a\r\n                  fixed deficit, typically following exertion or prolonged rest OR atypical history\r\n                  with otherwise typical exam findings (absent reflexes with normal sensation\r\n                  during an episode) OR unexplained hypokalemia between episodes OR abnormal\r\n                  long-exercise nerve conduction study\r\n\r\n               2. Heart conduction defects: prolonged QTc interval on 12-lead electrocardiogram OR\r\n                  ventricular ectopy, including uniform or multifocal PVCs, polymorphic VT, or\r\n                  bidirectional VT\r\n\r\n               3. Presence of two or more of the following physical features: low set ears,\r\n                  hypertelorism, small mandible, clinodactyly, syndactyly, micromelia of hands or\r\n                  feet --OR--\r\n\r\n          -  Meets one of the above three criteria and has at least one family member with two of\r\n             the criteria --OR--\r\n\r\n          -  Does not meet the above three criteria, but possesses a mutation in the KCNJ2 gene\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Less than 10 years of age\r\n      ","sponsor":"University of Rochester","sponsor_type":"Other","conditions":"Andersen-Tawil Syndrome|Andersen Syndrome","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Collect prospective standardized data from participants to help better define the clinical phenotype of ATS.","time_frame":"2 years"}]}
{"nct_id":"NCT01301651","start_date":"2007-11-30","phase":"Phase 1","enrollment":42,"brief_title":"Effects of Virtual Reality Training in Patients With Parkinson's Disease","official_title":"Effects of Virtual Reality Augmented Balance Training for Postural Control in Patients With Parkinson's Disease","primary_completion_date":"2008-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-12-31","last_update":"2011-10-17","description":"Background and Objective: Postural instability is common in patient with Parkinson's disease (PD). The purpose of this study was to investigate the effects of virtual reality (VR) balance training on sensory and cognitive domains of postural control. Setting: Balance Performance Laboratory. Participants: A total of 42 patients (Hoehn and Yahr stage II-III) were recruited and assigned into three groups randomly. Intervention: Participants in the virtual reality (VR) group and conventional balance training (CB) group received a 6 weeks balance training program. The control group (CG) did not receive any training. Outcome Measures: The sensory organization tests (SOT) of computerized dynamic posturography with single and dual tasks (i.e. with backward subtraction of number) were examined pre-, post-training and follow-up. The equilibrium score (ES) and sensory ratio were measured. The verbal reaction time (VRT) was recorded. Results: (1) Only VR significantly increased ES of SOT-6 (i.e., vestibular function at visual and somatosensory conflicting condition) post-training more than CG post-training in either single or dual task. (2) Only CB training significantly increased SOT-5 (i.e., vestibular function without visual conflict) and vestibular sensory ratio (i.e., SOT-5/SOT-1) more than CG post-training in either single or dual task. (3) (3) Neither VR nor CB training reduced VRT significantly under six sensory conditions at post-training and follow-up. Conclusion: Both VR training and CB training can improve sensory organization for postural control by enhancing utilization of vestibular information, but VR could enhance vestibular function with conflicting proprioceptive and visual information under single and dual tasks in patients with mild to moderate PD.","other_id":"200712039R","allocation":"Randomized","intervention_model":"Factorial Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":50,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        (1) idiopathic Parkinson's disease, (2) intact cognition (Mini-Mental State Examination;\r\n        MMSE>24), 22 (3) Hoehn and Yahr (H-Y) stage II-III diagnosed by neurologists, (4) not\r\n        participated in any balance or gait training previously, (5) able to follow simple command\r\n        and had no uncontrolled chronic condition.-\r\n\r\n        Exclusion Criteria:\r\n\r\n        (1) history of other neurological, cardiovascular and orthopedic diseases affecting\r\n        postural stability, (2) on-off motor fluctuation and dyskinesia above grade 3 by the\r\n        Unified Parkinson' Disease Scale (UPDRS)\r\n      ","sponsor":"National Taiwan University Hospital","sponsor_type":"Other","conditions":"Parkinson's Disease","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: balance training","description":"30 minute each time, 2 times per week for 6 weeks."}],"outcomes":[{"outcome_type":"primary","measure":"The equilibrium score (ES) and sensory ratio were measured. The verbal reaction time (VRT) was recorded.","time_frame":"6 weeks"}]}
{"nct_id":"NCT00735189","start_date":"2007-11-30","phase":"Phase 4","enrollment":96,"brief_title":"Does Anticoagulant Control Change Following Referral Back to the Primary Care Physician?","official_title":"Does Anticoagulant Control Change Following Referral Back to the Primary Care Physician? A Prospective Randomized Trial","primary_completion_date":"2010-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-04-30","last_update":"2010-06-24","description":"Warfarin is a medication typically referred to as a blood thinner and is used to prevent the formation of blood clots, and hence prevent life-threatening events such as strokes and clots on the lungs (known as pulmonary emboli). This therapy is only safe and effective if the degree of blood thinning is kept within a narrow window - if the blood is \"too thick\" clots may form but if the blood is \"too thin\" the risk of bleeding increases. Complicating the control of warfarin is that different people require different amounts of it to have an appropriate degree of blood thinning, and once this amount is determined for a patient, it may be changed by factors that are encountered on a daily basis (i.e., diet, acute and chronic diseases, alcohol, medications, etc.). As such, regular monitoring is necessary to confer the benefits of this medication. Our Anticoagulation Management Service (AMS) has demonstrated really good control of blood thinning therapy by working with patients to inform them of the rationale for this medicine, the factors having the ability to impact its control, and encouraging the patient to be involved in their care (via provision of tools to document test results, one-on-one education and access to our program at any time with questions, etc.) Currently, our AMS has to limit the volume of patients seen due to resource limitations. As such, it is imperative that we investigate alternate strategies to manage these patients. Paramount, however, is that any long-term strategy must not confer inferior control of warfarin. The purpose of this study is to determine if the impact of AMS Care is sustained following the transfer of anticoagulation management to the family doctor. Operationally, the results of this study will guide future management of patients. If control of warfarin therapy declines with family doctor management, alternate strategies, such as patient self-management, will need to be investigated in a larger scale trial.","other_id":"epicore ams1","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Health Services Research","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  current patient of the Anticoagulation Management Service\r\n\r\n          -  anticipated need for long term anticoagulation\r\n\r\n          -  have a regular primary care physician\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  previous failure of warfarin therapy (a bleed or clot despite therapeutic\r\n             anticoagulation\r\n\r\n          -  have a planned procedure (surgery) mandating discontinuation of warfarin\r\n\r\n          -  are taking warfarin for a mechanical valve indication\r\n      ","sponsor":"University of Alberta","sponsor_type":"Other","conditions":"Warfarin","interventions":[{"intervention_type":"Other","name":"Other: anticoagulation clinic care","description":"Patient receives care from the outpatient anticoagulation management service"},{"intervention_type":"Other","name":"Other: usual care","description":"patient receives usual anticoagulation care from their regular primary care physician"}],"outcomes":[{"outcome_type":"primary","measure":"Adequacy of anticoagulation control (proportion of time in the therapeutic anticoagulation range +/- 0.5 INR unit) by the Rosendaal method.","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Time within expanded therapeutic range (+/- 0.7 INR unit) by the Rosendaal method","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Rates of thrombosis between groups","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Rates of major hemorrhage between groups","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Patient satisfaction via postal survey","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Rate of crossover from primary care physician group back to anticoagulation management service","time_frame":"6 months"}]}
{"nct_id":"NCT00553267","start_date":"2007-11-30","phase":"Phase 3","enrollment":947,"brief_title":"Telmisartan/Amlodipine (80/10) vs. Telmisartan/Amlodipine (40/10) vs. amlodipine10 in Resistant Hypertension","official_title":"An Eight-week Randomised, Double-blind Study to Compare the Fixed-dose Combination of Telmisartan 40mg + Amlodipine 10mg Versus Telmisartan 80mg + Amlodipine 10mg Versus Amlodipine 10mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Amlodipine 10mg Monotherapy","primary_completion_date":"2008-10-31","study_type":"Interventional","rec_status":"Completed","last_update":"2014-02-13","description":"The primary objective of this trial is to demonstrate that the fixed dose combination of telmisartan 40mg + amlodipine 10mg (T40/A10) or the fixed dose combination of telmisartan 80mg + amlodipine 10mg (T80/A10) is superior in reducing blood pressure at eight weeks compared with amlodipine 10mg monotherapy (A10) in patients who fail to respond to six weeks treatment with A10.","other_id":"1235.6","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  diagnosis of essential hypertension and blood pressure not adequately controlled\r\n             before informed consent (inadequate control defined as seated diastolic blood pressure\r\n             (DBP) >= 95 mmHg if on existing antihypertensive treatment or seated DBP >= 100 mmHg\r\n             if treatment-nave).\r\n\r\n          -  failure to respond to six weeks treatment with amlodipine 10mg. (Failure to respond\r\n             defined as seated DBP >= 90 mmHg.)\r\n\r\n          -  able to stop any current antihypertensive therapy without unacceptable risk to the\r\n             patient.\r\n\r\n          -  willing and able to provide written informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  pregnancy, breast-feeding, unwilling to use effective contraception (if female of\r\n             child-bearing potential).\r\n\r\n          -  known or suspected secondary hypertension.\r\n\r\n          -  mean seated systolic blood pressure (SBP) >=200 mmHg and/or mean seated DBP >= 120\r\n             mmHg during run-in treatment or mean seated SBP >= 180 mmHg and/or mean seated DBP >=\r\n             120 mmHg at the randomisation visit or at any time during randomised treatment.\r\n\r\n          -  any clinically significant hepatic impairment or severe renal impairment bilateral\r\n             renal artery stenosis or renal artery stenosis in a solitary kidney or post post-renal\r\n             transplant.\r\n\r\n          -  clinically relevant hyperkalaemia.\r\n\r\n          -  uncorrected volume or sodium depletion.\r\n\r\n          -  primary aldosteronism.\r\n\r\n          -  hereditary fructose or lactose intolerance.\r\n\r\n          -  symptomatic congestive heart failure.\r\n\r\n          -  patients who have previously experienced symptoms characteristic of angioedema during\r\n             treatment with ACE inhibitors or ARBs.\r\n\r\n          -  history of drug or alcohol dependency within the six months prior to signing consent.\r\n\r\n          -  concurrent participation in another clinical trial or any investigational therapy\r\n             within thirty days prior to signing consent.\r\n\r\n          -  hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the\r\n             aortic or mitral valve.\r\n\r\n          -  known allergic hypersensitivity to any component of the formulations under\r\n             investigation. (Includes known hypersensitivity to telmisartan or other ARBs or\r\n             amlodipine or other dihydropyridine CCBs.)\r\n\r\n          -  non-compliance with study medication (defined as less than 80% or more than 120%)\r\n             during the open-label run-in treatment period.\r\n\r\n          -  current treatment with any antihypertensive agents, whether or not prescribed for this\r\n             indication, that cannot be safely stopped (investigators decision) by the start of\r\n             the run-in period.\r\n\r\n          -  chronic administration of any medication known to affect blood pressure, other than\r\n             the trial medication.\r\n\r\n          -  any other clinical condition which, in the opinion of the investigator, would not\r\n             allow safe completion of the protocol and safe administration of telmisartan and\r\n             amlodipine.\r\n      ","sponsor":"Boehringer Ingelheim","sponsor_type":"Industry","conditions":"Hypertension","interventions":[{"intervention_type":"Drug","name":"Drug: fixed dose combination of telmisartan+amlodipine"},{"intervention_type":"Drug","name":"Drug: amlodipine"}],"outcomes":[{"outcome_type":"primary","measure":"Change From Baseline in Trough Seated Diastolic Blood Pressure","time_frame":"Baseline and end of study (8 weeks or last value on treatment)","description":"Change from baseline to the end of study in trough DBP"},{"outcome_type":"secondary","measure":"Change From Baseline in Trough Seated Systolic Blood Pressure","time_frame":"Baseline and end of study (8 weeks or last value on treatment)","description":"Change from baseline to the end of study in trough SBP"},{"outcome_type":"secondary","measure":"Trough Seated Diastolic Blood Pressure Control (Defined as < 90mmHg)","time_frame":"End of study (8 weeks or last value on treatment)","description":"The number of patients who reach the target DBP of <90mmHg"},{"outcome_type":"secondary","measure":"Trough Seated Diastolic Blood Pressure <80 mmHg","time_frame":"End of study (8 weeks or last value on treatment)","description":"The number of patients who reach the target DBP of <80mmHg"},{"outcome_type":"secondary","measure":"Trough Seated DBP Response","time_frame":"End of study (8 weeks or last value on treatment)","description":"The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg"},{"outcome_type":"secondary","measure":"Trough Seated SBP Control","time_frame":"End of study (8 weeks or last value on treatment)","description":"The number of patients who reach the target SBP of <140mmHg"},{"outcome_type":"secondary","measure":"Trough Seated SBP Response","time_frame":"End of study (8 weeks or last value on treatment)","description":"The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg"},{"outcome_type":"secondary","measure":"Trough Seated BP Normality Classes","time_frame":"End of study (8 weeks or last value on treatment)","description":"The number of patients who reach predefined BP categories"},{"outcome_type":"secondary","measure":"Oedema Incidence Rate","time_frame":"During randomised treatment period","description":"The number of patients who experienced at least one case of oedema or worsening of oedema for the first time (expressed as number of patients/100 patient-years)"},{"outcome_type":"secondary","measure":"Peripheral Oedema Incidence Rate","time_frame":"During randomised treatment period","description":"The number of cases of peripheral oedema (expressed as number of cases/100 patient-years)"}]}
{"nct_id":"NCT00908648","start_date":"2007-11-30","phase":"N/A","enrollment":206,"brief_title":"The Use of Narrow Band Imaging in Screening Colonoscopy","official_title":"The Impact of Narrow Band Imaging in Screening Colonoscopy: a Randomized Controlled Trial.","primary_completion_date":"2008-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-04-30","last_update":"2021-04-26","description":"Narrow band imaging (NBI) is an imaging technique that allows a better definition of capillary pattern and improves the contrast between adenomas and the surrounding mucosa. Conflicting data exist on the ability of NBI in to improve detection of colonic neoplasm; the impact of NBI is being tested in several screening scenarios. The investigators evaluated whether the routine use of NBI, compared to white light (WL), during the withdrawal phase of screening colonoscopy improved adenoma detection.","other_id":"NBI-01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":50,"maximum_age":69,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  50-69 year-old asymptomatic subjects at average-risk of CRC\r\n\r\n          -  positive FOBT participating in a national mass-screening program and referred for\r\n             colonoscopy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  ongoing anticoagulation therapy\r\n\r\n          -  inadequate bowel cleansing\r\n\r\n          -  incomplete colonoscopy\r\n\r\n          -  refusing to participate\r\n      ","sponsor":"Valduce Hospital","sponsor_type":"Other","conditions":"Colonoscopy","interventions":[{"intervention_type":"Procedure","name":"Procedure: Narrow Band Imaging","description":"Narrow Band Imaging"}],"outcomes":[{"outcome_type":"primary","measure":"Adenoma Detection","time_frame":"duration of colonoscopy procedure","description":"Detection of adenoma, defined as the number of patients with > 1 adenoma, under White Light or NBI visualization"},{"outcome_type":"secondary","measure":"Detection of Flat and/or Depressed Adenomas","time_frame":"duration of colonoscopy procedure","description":"number of patients with at least 1 flat and/or depressed adenoma"}]}
{"nct_id":"NCT00803816","start_date":"2007-11-30","phase":"Phase 2","enrollment":12,"brief_title":"Everolimus for the Treatment of Uveitis Unresponsive to Cyclosporine A","official_title":"Everolimus for the Treatment of Uveitis Unresponsive to Cyclosporine A","primary_completion_date":"2010-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-12-31","last_update":"2015-05-27","description":"Study efficacy of everolimus on course of uveitis: - obtain quiescence of inflammation after start of treatment - duration to obtain quiescence of inflammation - number of patients with quiescence of inflammation","other_id":"2006-004876-10","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  endogenous intermediate or posterior uveitis\r\n\r\n          -  no quiesence in previous 3 months under systemic and topical steroids or systemic\r\n             cyclosporine A\r\n\r\n          -  indication for steroid sparing therapy\r\n\r\n          -  uveitis related vision threating complications\r\n\r\n          -  negative pregnancy test\r\n\r\n          -  effective contraception\r\n\r\n        Exclusion Criteria:\r\n\r\n        Ophthalmic parameters:\r\n\r\n          -  silicone oil in anterior chamber of both eyes para- or intraocular corticosteroid\r\n             injections within previous 8 weeks\r\n\r\n          -  opacities of optic media that obscure visualization of anterior or posterior eye\r\n             segments\r\n\r\n        General parameters:\r\n\r\n          -  requirement for combined immunosuppression for systemic immune-mediated disease\r\n             contraindication against everolimus or cyclosporine A\r\n\r\n          -  positive tuberculine test (GT 10\r\n\r\n          -  currently immunosuppressive therapy with immunosuppressive drug other than\r\n             cyclosporine\r\n\r\n          -  poor compliance\r\n\r\n          -  known intolerance to medication\r\n      ","sponsor":"Carsten Heinz","sponsor_type":"Other","conditions":"Uveitis","interventions":[{"intervention_type":"Drug","name":"Drug: everolimus","description":"everolimus 1.0 - 2.5mg oral daily dosage"}],"outcomes":[{"outcome_type":"primary","measure":"Inactivity of uveitis","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Reoccurence of uveitis","time_frame":"2 years"}]}
{"nct_id":"NCT00952146","start_date":"2007-11-30","phase":"N/A","enrollment":30,"brief_title":"Transgastric Peritoneoscopy and Appendectomy","official_title":"Transgastric Diagnostic Peritoneoscopy (Laparoscopy) and Appendectomy - A Pilot Study","primary_completion_date":"2010-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2010-12-31","last_update":"2009-08-06","description":"This study is a feasibility study. Patients with acute abdominal pain who are planning to undergo a diagnostic laparoscopy are asked to participate in the study. The aim of the study is to evaluate if transgastric peritoneoscopy is feasible.","other_id":"South Alvsborg Hospital","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patient with acute abdominal pain\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patient under 18\r\n\r\n          -  Patient who cannot understand information in Swedish\r\n\r\n          -  Patients previously operated in upper part of the abdomen\r\n      ","sponsor":"Sodra Alvsborgs Hospital","sponsor_type":"Other","conditions":"Abdominal Pain","interventions":[{"intervention_type":"Procedure","name":"Procedure: Transgastric peritoneoscopy (NOTES)","description":"Under general anesthesia an endoscope will be passed through the gastric wall into the peritoneal cavity to examine the peritoneal cavity. At the withdrawal of the endoscope, the gastric access in the stomach wall will be closed with T-tags."}],"outcomes":[{"outcome_type":"primary","measure":"To test the feasibility of transgastric peritoneoscopy","time_frame":"When discharged from hospital, 1 month post-op and one year"}]}
{"nct_id":"NCT00623649","start_date":"2007-11-30","phase":"Phase 1","enrollment":42,"brief_title":"Safety,Tolerability and Pharmacokinetics of Multiple Ascending Doses of VCH 916 in Subjects With Chronic Hep C Infection","official_title":"A Phase 1B, Multicentre, Randomized, Double-Blinded, and PLacebo-Controlled Study of the Antiviral Activity, Safety, Tolerability, and PK of Multiple Ascending Doses of VCH-916 in the Treatment Naive or Experienced Subjects With Chronic Hep C-Infection.","primary_completion_date":"2008-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-10-31","last_update":"2014-04-04","description":"The purpose of this study is to determine whether a 3-day course of therapy with orally administered VCH-916 given at different dosages can effectively reduce the amount of circulating virus (i.e., viral load) in patients with early-stage chronic hepatitis C-infection. This study will also evaluate the safety and tolerability of treatment with VCH-916. Blood samples will also be taken to measure the levels of VCH-916 present in plasma at various time points during the treatment period.","other_id":"VCH 916-103","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Males and females 18 to 60 years of age\r\n\r\n          -  No evidence of cirrhosis or have liver fibrosis corresponding to Metavir Stages 0 to 3\r\n\r\n          -  Subject's liver disease is stable with ALT values < 5 X ULN\r\n\r\n          -  Serologic evidence of detectable plasma HCV-RNA of  100,000 IU/ml at screening\r\n\r\n          -  Documented HCV Genotype 1 chronic hepatitis C.\r\n\r\n          -  Judged to be in good health on the basis of medical history and physical examination\r\n\r\n          -  All other hematology and clinical chemistry must be within normal limits or show no\r\n             clinically significant abnormalities.\r\n\r\n          -  Be treatment-nave or experienced.\r\n\r\n          -  For female subjects, must not be pregnant or breastfeeding and must be postmenopausal,\r\n             surgically sterile, abstinent, or using two proven methods of birth control.\r\n\r\n          -  Sexually active male subjects, must be practicing acceptable methods of contraception\r\n             during the treatment period\r\n\r\n          -  Female subjects of childbearing potential must have a negative serum -HCG pregnancy\r\n             test at screening and a negative urine pregnancy test on Day 1 before the first dose\r\n             of study drugs.\r\n\r\n          -  Agree not to participate in other clinical trials for the duration of his/her\r\n             participation in this clinical trial.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Be participating in any other clinical studies or have participated in another\r\n             clinical trial within the last 30 days before study drug administration, or\r\n             participation in more than 2 drug studies in the last 12 months (exclusive of the\r\n             current study).\r\n\r\n          -  Be actively taking hard illicit drugs within 12 months prior to the screening visit or\r\n             alcohol.\r\n\r\n          -  Have a Child-Pugh score > than 5.\r\n\r\n          -  Have evidence of liver cirrhosis including histological evidence of hepatic cirrhosis\r\n             on any liver biopsy.\r\n\r\n          -  Have any cause of liver disease other than chronic hepatitis C-infection\r\n\r\n          -  Active or malignant disease or suspicion or history of malignant disease within five\r\n             previous years (except for adequately treated basal cell carcinoma).\r\n\r\n          -  Have clinically significant electrocardiogram abnormalities and/or cardiovascular\r\n             dysfunction within the previous 6 months\r\n\r\n          -  Have significant renal, pulmonary, gastrointestinal absorption, or neurological\r\n             diseases, or neoplasia.\r\n\r\n          -  Have a history of psychiatric disorders determined by the investigator to\r\n             contraindicate therapy.\r\n\r\n          -  Have uncontrolled Type 1 or Type II diabetes.\r\n\r\n          -  Antinuclear antibody titer 1:320.\r\n\r\n          -  Coinfection with hepatitis B and/or HIV 1 or HIV 2.\r\n      ","sponsor":"Vertex Pharmaceuticals Incorporated","sponsor_type":"Industry","conditions":"HCV Infection","interventions":[{"intervention_type":"Drug","name":"Drug: VCH 916","description":"Dose escalation study with a full review of all safety data following each cohort."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Dose escalation study with a full review of all safety data following each cohort."}],"outcomes":[{"outcome_type":"primary","measure":"The primary objective of this trial is to assess the antiviral activity, safety, and tolerability of VCH-916 monotherapy in adult subjects with chronic HCV-infection.","time_frame":"Day 1 to Day 17 visits"},{"outcome_type":"secondary","measure":"To evaluate the pharmacokinetic (PK) profile of VCH-916 in HCV-infected adults.","time_frame":"Day 1 visit"},{"outcome_type":"secondary","measure":"To establish the relationship between VCH-916 plasma levels and corresponding HCV RNA reduction with the administered dosages of VCH-916 in adults.","time_frame":"Day 1 to Day 4 visits"},{"outcome_type":"secondary","measure":"To study the kinetics of plasma HCV RNA following treatment for up to three(3) days with VCH-916.","time_frame":"Day 1 to Day 4 visits"}]}
{"nct_id":"NCT00557258","start_date":"2007-11-30","enrollment":14956,"brief_title":"Cross-Sectional Study: Prevalence of Restless Legs Syndrome in Patients With Unpleasant Sensations of the Legs","official_title":"Prevalence of Restless Legs Syndrome in Patients With Unpleasant Sensations of the Legs","primary_completion_date":"2007-11-30","study_type":"Observational","rec_status":"Completed","last_update":"2009-02-13","description":"The proposed study is a Cross-sectional epidemiological study, performed in 330 primary care practices in Germany. The study will be conducted on a fixed day in November 2007. Primary care surgeries throughout Germany will be asked to take part. The study material will be delivered to the surgery by a member of sales-force who will also explain the study conduct to the physician/staff. Physicians who want to take part in the study will send a signed contract to BI. Physicians will be trained to diagnose RLS. All patients attending the participating surgeries on a fixed day will be invited to participate in the study. The patients will be handed a questionnaire to fill out while waiting for their appointment. No patient-related data apart from gender and year of birth will be recorded on the questionnaire and it will be ensured that no re-identification of patients is possible. Therefore, no written informed consent will be obtained from the participants. The patient questionnaire will consist of the following items: A screening questionnaire for RLS (according to Stiasny-Kolster et. al., data on file) Additional questions concerning the impact of the patients leg problems on daily life. The practice staff will then collect the questionnaire. All patients who have answered question 1 (asking for unpleasant sensations of the legs) with Yes will subsequently be assessed for the diagnosis by the physician. The physician fills out a second questionnaire, covering the following items: Diagnosis (cause of leg problems) Concomitant diagnoses and therapies If the diagnosis of RLS was made: consequences (therapy)? Was the diagnosis of RLS pre-known? All completed questionnaires will be sent to data management by the surgery within 2 working days.","other_id":"248.652","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients attending one of the participating primary care surgeries on a fixed day\r\n\r\n          -  Male or female patients of any age\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who only attend the practice to get a prescription and are not seen by the\r\n             doctor on that day.\r\n\r\n          -  Patients who are not able to understand the questionnaire due to mental impairment or\r\n             language problems.\r\n\r\n          -  Children and adolescents under the age of 18 years\r\n      ","sponsor":"Boehringer Ingelheim","sponsor_type":"Industry","conditions":"Restless Legs Syndrome","interventions":{},"outcomes":{}}
{"nct_id":"NCT01318070","start_date":"2007-11-30","phase":"Phase 2/Phase 3","enrollment":339,"brief_title":"Efficacy and Safety of Alogliptin Used Combination With Thiazolidine in Participants With Type 2 Diabetes in Japan","official_title":"A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of SYR-322 When Used in Combination With Thiazolidine in Subjects With Type 2 Diabetes in Japan","primary_completion_date":"2008-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-10-31","last_update":"2012-02-03","description":"The purpose of this study was to evaluate the efficacy and safety of alogliptin, once daily (QD) combined with a thiazolidine taken QD in type 2 diabetic patients with uncontrolled blood glucose.","other_id":"SYR-322/CCT-004","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":33,"maximum_age":88,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Had been taking pioglitazone at a stable dose (15 mg/day or 30 mg/day) for at least 16\r\n             weeks prior to the start of the treatment period (Week 0).\r\n\r\n          2. Had glycosylated hemoglobin (HbA1c) of 6.5% or more and below 10.0% at 14 weeks after\r\n             the start of the observation period (Week -2).\r\n\r\n          3. Had HbA1c difference within 10.0%* at 10 weeks after the start of the observation\r\n             period (Week -6) and 14 weeks after the start of the observation period (Week -2) from\r\n             10 weeks after the start of the observation period (Week -6) (*rounded off to the\r\n             first decimal place).\r\n\r\n          4. Was receiving specific diet and exercise (if any) therapies during the observation\r\n             period.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Had taken a diabetic medications other than pioglitazone within 16 weeks before the\r\n             start of the treatment period (Week 0).\r\n\r\n          2. Had a history or symptoms of cardiac failure.\r\n      ","sponsor":"Takeda","sponsor_type":"Industry","conditions":"Type 2 Diabetes Mellitus","interventions":[{"intervention_type":"Drug","name":"Drug: Alogliptin and pioglitazone","description":"Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks."},{"intervention_type":"Drug","name":"Drug: Alogliptin and pioglitazone","description":"Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks."},{"intervention_type":"Drug","name":"Drug: Pioglitazone","description":"Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks."}],"outcomes":[{"outcome_type":"primary","measure":"Change From Baseline in Glycosylated Hemoglobin (Week 12).","time_frame":"Baseline and Week 12.","description":"The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and glycosylated hemoglobin collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Glycosylated Hemoglobin (Week 2).","time_frame":"Baseline and Week 2.","description":"The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 2 and glycosylated hemoglobin collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Glycosylated Hemoglobin (Week 4).","time_frame":"Baseline and Week 4.","description":"The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and glycosylated hemoglobin collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Glycosylated Hemoglobin (Week 8).","time_frame":"Baseline and Week 8.","description":"The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Fasting Plasma Glucose (Week 2).","time_frame":"Baseline and Week 2.","description":"The change between the value of fasting plasma glucose collected at week 2 and glycosylated hemoglobin collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Fasting Plasma Glucose (Week 4).","time_frame":"Baseline and Week 4.","description":"The change between the value of fasting plasma glucose collected at week 4 and glycosylated hemoglobin collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Fasting Plasma Glucose (Week 8).","time_frame":"Baseline and Week 8.","description":"The change between the value of fasting plasma glucose collected at week 8 and glycosylated hemoglobin collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Fasting Plasma Glucose (Week 12).","time_frame":"Baseline and Week 12.","description":"The change between the value of fasting plasma glucose collected at week 12 or final visit and glycosylated hemoglobin collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).","time_frame":"Baseline and Week 12.","description":"The change between the value of blood glucose measured by the meal tolerance test collected at week 12 or final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and 2 hours after the start of the meal."}]}
{"nct_id":"NCT01228786","start_date":"2007-10-31","enrollment":50,"brief_title":"Regulation of Vitamin D Receptor (VDR),Calcium Sensing Receptor (CaSR), Cyclin D1,Ki67 and Proliferating Cell Nuclear Antigen (PCNA) in Primary Hyperparathyroidism","official_title":"Transcriptional and Translational Regulation of Vitamin D Receptor (VDR) and Calcium Sensing Receptor (CaSR) in Patients With Sporadic Primary Hyperparathyroidism","primary_completion_date":"2012-12-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2013-06-30","last_update":"2012-07-20","description":"The present study is designed to examine the expression of VDR, CaSR, PTH, Cyclin D1, Ki67 and PCNA and to find out its relationship with clinical parameters in parathyroid adenomas. Examination of the contribution of genes expression can elucidate the critical link between proliferation and functional abnormalities in parathyroid adenomas. Alternative to DNA and RNA, protein expression can provide a better understanding of this disease.","other_id":"BHADADA-PGI","observational_model":"Case-Control","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","population":"Patients with Primery Hyperparathyroidism (PHPT)","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with surgically verified sporadic PHPT\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with hyperplasia, renal failure and multiple endocrine neoplasia\r\n      ","sponsor":"Postgraduate Institute of Medical Education and Research","sponsor_type":"Other","conditions":"Primary Hyperparathyroidism (PHPT)","interventions":{},"outcomes":{}}
{"nct_id":"NCT00920179","start_date":"2007-10-31","enrollment":30,"brief_title":"Confocal Microscopy and Lacrimal Gland in Sjogren's Syndrome","official_title":"The Application of In Vivo Confocal Scanning Laser Microscopy in the Evaluation of the Secretory Glands in Patients With Sjgren's Syndrome","primary_completion_date":"2010-12-31","study_type":"Observational","rec_status":"Unknown status","last_update":"2009-06-15","description":"Traditional methodological clinical and instrumental diagnostics of the lacrimal gland for the study of glandular architecture and functions are limited and include analysis of tear constituents, evaluation of apparent diffusion coefficients in magnetic resonance imaging and histopathological evaluation of lacrimal gland biopsy specimens. Confocal microscopy is a new emerging technology which is useful as a supplementary diagnostic tool for in vivo assessment of anterior-segment disorders.The use of in vivo confocal microscopy in a comparative study of the microscopic morphology of the salivary/lacrimal glands have not been reported up to date. In this study, we employ laser scanning confocal microscopy to evaluate the morphological changes of the salivary/lacrimal glands in patients with primary Sjgren's syndrome and compare the results with those of healthy control subjects.","other_id":"21071965","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":20,"maximum_age":80,"population":"Patients with primary SS and healthy controls","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  The Sjgren's syndrome diagnosis was made according to the revised American-European\r\n             consensus criteria.\r\n\r\n          -  Briefly, the patients had to have ocular and oral symptoms of dryness,\r\n\r\n          -  clinically diagnosed dry eye and dry mouth disease,\r\n\r\n          -  serum rheumatoid factor and antinuclear antibody levels 1:160,\r\n\r\n          -  positive serology for anti SS-A or anti SS-B antibodies,\r\n\r\n          -  labial salivary gland inflammatory infiltration focus score 2 and consents for\r\n             lacrimal gland biopsy to be included into this study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with any history of ocular surgery including punctal occlusion,\r\n\r\n          -  other ocular or systemic disease\r\n\r\n          -  or a history of topical/ systemic drug use or contact lens wear or\r\n\r\n          -  other systemic disorders that would cause dry eyes or that would alter the ocular\r\n             surface.\r\n      ","sponsor":"Keio University","sponsor_type":"Other","conditions":"Primary Sjogren's Syndrome","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Inflammatory cell density","time_frame":"1.5 years"}]}
{"nct_id":"NCT00607152","start_date":"2007-10-31","phase":"Phase 3","enrollment":10,"brief_title":"Rasburicase (Fasturtec) Registration Trial","official_title":"A Multi-center, Randomized, Open-label, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Rasburicase (Fasturtec) in the Prevention and Treatment of Hyperuricemia in Patients With Hematological Malignancies","primary_completion_date":"2009-01-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2009-01-31","last_update":"2014-05-08","description":"Primary: To compare the efficacy of Rasburicase versus allopurinol in controlling tumor lysis-related hyperuricemia in Chinese patients with leukemia or lymphoma. Secondary: To compare the efficacy and safety of Rasburicase versus allopurinol in Chinese patients stratified according to disease (leukemia or lymphoma ).","other_id":"RASBU_L_00351","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  At high risk of malignancy and/or chemotherapy-induced hyperuricemia\r\n\r\n          -  Performance status less than 3 on ECOG scale or more than 30% KPS scale\r\n\r\n          -  Uric acid concentrations  8.0mg/dL\r\n\r\n          -  Suffering from non-Hodgkin's lymphoma Stage more than III, or acute lymphoblastic\r\n             leukemia with peripheral with blood cell count more than 25,000/mm3, or any lymphoma\r\n             or leukemia\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Treatment with an investigational drug at any time during the 14-day study period\r\n             (except for agents that are permitted by the Sponsor)\r\n\r\n          -  Pregnancy or lactation\r\n\r\n          -  Prior treatment with Uricozyme or Rasburicase\r\n\r\n          -  Scheduled to receive asparaginase either 24 hours after the first dose of rasburicase\r\n\r\n          -  Treatment with Allopurinol within the seven days preceding study Day 1\r\n\r\n          -  History of significant atopic allergy problems or documented history of asthma\r\n\r\n          -  History of severe reaction to allopurinol\r\n\r\n          -  Known history of glucose-6-phosphate dehydrogenase deficiency.\r\n\r\n        The above information is not intended to contain all considerations relevant to a patient's\r\n        potential participation in a clinical trial.\r\n      ","sponsor":"Sanofi","sponsor_type":"Industry","conditions":"Hyperuricemia","interventions":[{"intervention_type":"Drug","name":"Drug: Rasburicase","description":"0.20mg/kg per day IV"},{"intervention_type":"Drug","name":"Drug: Allopurinol","description":"100mg tablets"}],"outcomes":[{"outcome_type":"primary","measure":"Mean plasma uric acid AUC0-96","time_frame":"0hour, 4hour, 12 hour and q12h thereafter"},{"outcome_type":"primary","measure":"Median duration of therapy until control of plasma uric acid values to <8.0 mg/dL (only in patients hyperuricemic immediately prior to dosing)","time_frame":"From administration of drug up to end of study"},{"outcome_type":"primary","measure":"Biochemistry, hematology, vital signs, physical examination, and adverse events","time_frame":"From administration of drug up to end of study"},{"outcome_type":"primary","measure":"Proportion of patients developing hypertension requiring therapy","time_frame":"From administration of drug up to end of study"},{"outcome_type":"primary","measure":"Assays for circulating antibodies","time_frame":"From administration of drug up to end of study"},{"outcome_type":"secondary","measure":"Percentage reduction of plasma uric acid concentrations at T4h","time_frame":"From administration of drug up to end of study"},{"outcome_type":"secondary","measure":"Mean plasma uric acid concentrations","time_frame":"At various timepoints"},{"outcome_type":"secondary","measure":"Median duration of therapy until control of plasma uric acid values to <8.0 mg/dL","time_frame":"From administration of drug up to end of study"}]}
{"nct_id":"NCT00484471","start_date":"2007-10-31","phase":"Phase 4","enrollment":127,"brief_title":"ABLE: Abilify in Bipolar Disorder for Long-term Effectiveness","official_title":"A Double Blind, Randomized, Placebo Controlled Trial of Aripiprazole Plus Valproate in the Short-Term and Long-Term Treatment of Bipolar Disorder","primary_completion_date":"2011-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-11-30","last_update":"2012-11-28","description":"To compare combination treatment of aripiprazole plus valproate versus valproate alone in the prevention of relapse in bipolar I disorder patients with symptomatic remission after 5-6 weeks open-label acute treatment with aripiprazole plus valproate for manic or mixed episode, with or without psychotic features.","other_id":"031-OTB-0701","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Subjects able to give informed consent, and/or consent obtained from a legally\r\n             acceptable representative (as required by IRB/IEC) prior to the initiation of any\r\n             protocol required procedures;\r\n\r\n          2. Subjects with Bipolar I Disorder, manic or mixed episode, with or without psychotic\r\n             features, as defined by DSM-IV-TR and confirmed by the M.I.N.I.;\r\n\r\n          3. Subjects who are able to understand the nature of the study and follow protocol\r\n             requirements including the prescribed dosage regimens, capsule/tablet ingestion,\r\n             discontinuation of prohibited concomitant medications, and who can be reliably rated\r\n             on assessment scales;\r\n\r\n          4. Subjects willing to discontinue all medication starting from the signing of the\r\n             informed consent and during the study phases (allowed exceptions noted in Section\r\n             6.4.2);\r\n\r\n          5. Men or women aged  18 and  65 years;\r\n\r\n          6. Subjects with YMRS total score  20 (to be assessed prior entry into open-label acute\r\n             treatment phase);\r\n\r\n          7. YMRS total score  12 for 2 consecutive visits (to be assessed at Week 5 and/or Week6\r\n             prior entry into double-blind treatment phase).\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for\r\n             the entire study period and for up to four weeks after completion of the study.\r\n             Acceptable methods include oral, injectable or implanted contraceptives, intrauterine\r\n             devices or barrier methods such as condoms, diaphragm, and spermicides;\r\n\r\n          2. Women who are pregnant or breast-feeding;\r\n\r\n          3. Subjects presenting clinically with a current DSM-IV-TR diagnosis of delirium,\r\n             dementia, amnestic or other cognitive disorders, or a psychotic disorder (e.g.,\r\n             schizophrenia or schizoaffective disorder). Also, subjects with borderline, paranoid,\r\n             histrionic, schizotypal, schizoid, or antisocial personality disorder;\r\n\r\n          4. Subjects with a current Axis I (DSM-IV-TR) diagnosis of Bipolar II Disorder, rapid\r\n             cyclers (experiencing four or more manic or depressive episodes per year), Bipolar\r\n             Disorder NOS, or any other primary psychiatric disorder other than Bipolar I Disorder;\r\n\r\n          5. Subjects with documented evidence of first manic episode;\r\n\r\n          6. Subjects considered treatment refractory for manic symptoms; (Note: if a subject has\r\n             failed  2 antimanic treatments, e.g., antipsychotic, lithium, valproate or\r\n             carbamazepine at therapeutic dose and duration, exclusive of the current episode,\r\n             obtain permission from the Otsuka medical monitor to include the subject)\r\n\r\n          7. Subjects previously nonresponsive to aripiprazole for manic symptoms;\r\n\r\n          8. Subjects with a significant risk of committing suicide based on history, mental status\r\n             exam, or investigator's judgment;\r\n\r\n          9. Subjects who have met DSM-IV-TR criteria for substance abuse within the past three\r\n             months, or substance dependence* within the past 6 months, including benzodiazepines;\r\n             (* exceptional for subjects with substance dependence on nicotine or caffeine);\r\n\r\n         10. Subjects with thyroid pathology (e.g., hypothyroidism or hyperthyroidism) unless\r\n             condition has been stabilized with medications for at least the past three months;\r\n             (Note: Subjects with an abnormal thyroid function test may be retested prior to the\r\n             start of study medication. Subjects with an abnormal thyroid function test at\r\n             screening will not be eligible for the study, unless permission is obtained from\r\n             Otsuka);\r\n\r\n         11. Subjects who have a history or evidence of a medical condition that would expose them\r\n             to an undue risk of a significant adverse event or interfere with assessments of\r\n             safety or efficacy during the course of the trial, including but not limited to\r\n             hepatic, renal, respiratory, cardiovascular, endocrine (e.g., Addison's Disease),\r\n             immune, neurologic, or hematologic disease as determined by the clinical judgment of\r\n             the investigator;\r\n\r\n         12. Subjects with a significant history of seizure disorder (e.g., epilepsy);\r\n\r\n         13. The following laboratory tests results, vital signs, and ECG findings are\r\n             exclusionary:\r\n\r\n               -  Platelets  75000/mm3\r\n\r\n               -  Hemoglobin  9g/dL\r\n\r\n               -  Neutrophils, absolute  1000/ mm3\r\n\r\n               -  SGOT (AST) > 3x Upper Limit of Normal\r\n\r\n               -  SGPT (ALT) > 3x Upper Limit of Normal\r\n\r\n               -  Creatinine  2 mg/dL\r\n\r\n               -  QTc > 475 msec\r\n\r\n         14. Subjects with a recent antipsychotic use who have a CPK  550 IU (Otsuka should be\r\n             contacted to discuss any elevated CPK levels);\r\n\r\n         15. Subjects who are known to be allergic, intolerant, or unresponsive to valproate or to\r\n             aripiprazole;\r\n\r\n         16. Subjects with a history of neuroleptic malignant syndrome from antipsychotic agents;\r\n\r\n         17. Subjects likely to require prohibited concomitant therapy during the study as\r\n             indicated in Section 6.4 of the protocol;\r\n\r\n         18. Recent treatment of their most recent manic or mixed acute episode with a long acting\r\n             antipsychotic in which the last dose was less than one full cycle plus one week prior\r\n             to entering Phase 2 (haloperidol decanoate treatment within the past five weeks,\r\n             fluphenazine decanoate treatment within the past three weeks or Risperdal ConstaTM\r\n             treatment within the past three weeks);\r\n\r\n         19. Subjects likely to require the initiation of intensive individual psychotherapy during\r\n             the course of the study (Note: Group and supportive therapy is allowed, if part of the\r\n             subject's ongoing treatment. Individual psychotherapy is allowed if the subject has\r\n             consistently received psychotherapy for at least 3 months prior to the study and will\r\n             continue during the study);\r\n\r\n         20. ECT treatment within the current episode or within two months prior to the study;\r\n\r\n         21. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for\r\n             treatment of either a psychiatric or physical (e.g., infectious disease) illness must\r\n             not be enrolled into this study.\r\n      ","sponsor":"Korea Otsuka International Asia Arab","sponsor_type":"Industry","conditions":"Bipolar Disorder","interventions":[{"intervention_type":"Drug","name":"Drug: aripiprazole","description":"15-30 mg/day aripiprazole, 22 weeks"},{"intervention_type":"Drug","name":"Drug: valproate","description":"sufficient dose as determined by investigator to maintain the therapeutic level."},{"intervention_type":"Drug","name":"Drug: placebo","description":"placebo to aripiprazole, 22 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Time to relapse in double-blind treatment phase","time_frame":"throughout the study"},{"outcome_type":"secondary","measure":"Mean change from baseline to all time point in YMRS total score;","time_frame":"throughout the study"},{"outcome_type":"secondary","measure":"Mean change from baseline to all time points in MADRS total score","time_frame":"throughout the study"},{"outcome_type":"secondary","measure":"Response rate (≥ 50% improvement in YMRS total score) at all time points","time_frame":"throughout the study"}]}
{"nct_id":"NCT01727752","start_date":"2007-10-31","phase":"N/A","enrollment":386,"brief_title":"A Randomized Controlled Trial Comparing Surgical Decompression With an Interlaminar Implant in Patients With Intermittent Neurogenic Claudication Caused by Lumbar Stenosis","official_title":"A Randomized Controlled Trial Comparing Surgical Decompression With an Interlaminar Implant in Patients With Intermittent Neurogenic Claudication Caused by Lumbar Stenosis","primary_completion_date":"2015-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-06-30","last_update":"2016-03-31","description":"A Randomized, Blinded Comparison of Surgical Intervention with the Coflex Interspinous Implant versus Surgical Decompression for Patients with Intermittent Neurogenic Claudication caused by Lumbar Stenosis","other_id":"NTR1307","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":40,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  signed informed consent\r\n\r\n          -  is 40 to 85 years old at time of surgery\r\n\r\n          -  has INC, as noted by leg/buttock/groin pain with or without back pain.\r\n             Leg/buttock/groin pain needs to be strongly relieved when flexed such as when sitting\r\n             in a chair\r\n\r\n          -  has received at least three months of conservative care therapy which may have\r\n             included, but is not limited to, physical therapy, bracing, systemic and/or injected\r\n             medications\r\n\r\n          -  has a regular indication for surgical intervention of INC\r\n\r\n          -  has a narrowed lumbar spinal canal, nerve root canal or intervertebral foramen at one\r\n             or two levels confirmed by MRI\r\n\r\n          -  is physically and mentally willing and able to comply with, or has a caregiver who is\r\n             willing and able to comply with, the post-operative evaluations.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  has cauda equina syndrome defined as neural compression causing neurogenic bowel\r\n             (rectal incontinence) or bladder dysfunction (bladder retention or incontinence)\r\n\r\n          -  has Paget's disease, severe osteoporosis or metastasis to the vertebrae\r\n\r\n          -  has significant scoliosis (Cobb angle > 25 degrees)\r\n\r\n          -  has a Body Mass Index (BMI) > 40 kg/m2\r\n\r\n          -  has had any surgery of the lumbar spine\r\n\r\n          -  has degenerative spondylolisthesis > grade 1 (on a scale 1 to 4) at the affected level\r\n\r\n          -  has significant instability of the lumbar spine\r\n\r\n          -  has severe comorbid conditions that will increase the risk to the patient or interfere\r\n             with the evaluability of this study\r\n\r\n          -  has a fused segment at the indicated level.\r\n\r\n          -  has a herniated disk on the level of interest\r\n      ","sponsor":"Paradigm Spine","sponsor_type":"Industry","conditions":"Intermittent Neurogenic Claudication (INC) as a Result of Spinal Stenosis","interventions":[{"intervention_type":"Procedure","name":"Procedure: Decompression"}],"outcomes":[{"outcome_type":"primary","measure":"Zurich Claudication Questionnaire (ZCQ)","time_frame":"5 years","description":"ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis."},{"outcome_type":"secondary","measure":"EuroQOL (EQ-5D)","time_frame":"5 years","description":"The EuroQol (EQ-5D) will be used for the cost utility analysis at the end of the investigation."},{"outcome_type":"secondary","measure":"MRDQ","time_frame":"5 years","description":"The 23-points MRDQ is the most widely used patient-assessed measure of health outcome for low back pain."},{"outcome_type":"secondary","measure":"SF-36","time_frame":"5 years","description":"The SF-36 questionnaire relates to the analysis of the general functional status and Quality of Life of patients."},{"outcome_type":"secondary","measure":"McGill Pain Questionnaire","time_frame":"5 years","description":"The McGill questionnaire measures the quality aspect of pain, next to the intensity of pain."},{"outcome_type":"secondary","measure":"VAS Leg Pain","time_frame":"5 years","description":"Improvement of the Visual Analog Scale (VAS) for leg pain (on the 100 mm scale) compared to control group"},{"outcome_type":"secondary","measure":"Re-operations, revisions, and major complications","time_frame":"5 years","description":"Assessment of revisions, removals, re-operations, and major device-related complications."},{"outcome_type":"secondary","measure":"Radiographic Assessment","time_frame":"12 months","description":"Radiographic Assessment of coflex and control group"}]}
{"nct_id":"NCT00541710","start_date":"2007-10-31","phase":"Phase 2/Phase 3","enrollment":120,"brief_title":"Effect of Genistein in Women With Metabolic Syndrome","official_title":"Genistein Use in Postmenopausal Women With Metabolic Syndrome","primary_completion_date":"2011-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-09-30","last_update":"2012-09-14","description":"The purpose of this study is to determine whether the phytoestrogen genistein is effective in improving bone condition in pre-menopausal and post-menopausal women suffering for osteopenia. Since, during the study the investigators realized that at least 70% of post-menopausal recruited women suffered for metabolic syndrome (MS), we have added only in these women, as secondary outcome measures, the evaluation of markers of cardiovascular risk.","other_id":"RODA-12254","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"Female","minimum_age":45,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Post-menopausal satus\r\n\r\n        The presence of three or more of the five following criteria:\r\n\r\n        waist circumference 88 cm; Triglycerides 150 mg/dl or on drug treatment for elevated\r\n        triglycerides; high-density-lipoprotein (HDL) cholesterol <50 mg/dl or on drug treatment\r\n        for reduced HDL-C; Fasting glucose 100 mg/dl or on drug treatment for elevated glucose;\r\n        Blood pressure 130/85 mmHg or on antihypertensive drug treatment in a subject with a\r\n        history of hypertension.\r\n\r\n        Exclusion Criteria:\r\n\r\n        clinical or laboratory evidence of confounding systemic diseases (e.g., chronic renal or\r\n        hepatic failure, chronic inflammatory diseases) cardiovascular disease (CVD) defined as\r\n        documented myocardial infarction, ischaemic heart disease, coronary heart bypass, coronary\r\n        angioplasty, cerebral thromboembolism, and peripheral amputations, or by Minnesota codes\r\n        11-3, 41-4, 51-3 at a standard ECG performed in the 12 months preceding the study;\r\n        coagulopathy; use of oral or transdermal estrogen, progestin, androgens, selective estrogen\r\n        receptor modulators, or other steroids; treatment in the preceding six months with\r\n        polyunsaturated n-3 fatty acids supplements, non steroidal anti-inflammatory drugs (NSAIDs)\r\n        or steroids, that would interfere with evaluation of the study medication; smoking habit of\r\n        more than 2 cigarettes daily.\r\n      ","sponsor":"University of Messina","sponsor_type":"Other","conditions":"Metabolic Syndrome","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: genistein","description":"pills of 27 mg, twice per day for 12 months"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: placebo","description":"sugar pills twice per day for 12 months"}],"outcomes":[{"outcome_type":"secondary","measure":"body mass index","time_frame":"baseline, 6 months and 12 months","description":"The body mass index (BMI) is calculated by dividing the weight measured in kilograms by the square of the height measured in metres [i.e. BMI = Weight (kg)/ Height (m)]2."},{"outcome_type":"secondary","measure":"Blood pressure","time_frame":"basal, 6 and 12 months","description":"Three seated blood pressure measurements were taken on the right arm with a sphygmomanometer after the participant had been resting for at least 5 min. Blood pressure values were based on the average of the second and third measurements."},{"outcome_type":"secondary","measure":"Inflammatory markers","time_frame":"basal, 6 and 12 months","description":"Serum visfatin, adiponectin, and homocysteine were measured by using an immunoenzymatic assay was measured by using an immunoenzymatic assay."},{"outcome_type":"primary","measure":"markers of bone reabsorption: CTX (C-telopeptide of type I collagen ) and of bone formation: bone ALP (Alkaline phosphatase), plus calcaneus ultrasonography variation values","time_frame":"baseline and six months for markers of bone reabsorption, while baseline and 12 months for evaluation of calcaneus ultrasonography variation values"},{"outcome_type":"primary","measure":"homeostasis model assessment for insulin resistance (HOMA-IR)","time_frame":"change from baseline at 6 and 12 months","description":"HOMA-IR was calculated using the following formula: fasting glucose (mg/dl) X fasting insulin (uIU/ml)/22.5."},{"outcome_type":"secondary","measure":"Metabolic variables","time_frame":"basal, 6 and 12 months","description":"Fasting glucose and insulin were measured in serum collected after an overnight fast using routine methods. Total cholesterol, High Density Lipoprotein-Cholesterol (HDL-C), and triglycerides were measured by using a routine enzymatic method, and the Low-Density Lipoprotein Cholesterol (LDL-C) level was calculated by using the Friedewald formula: [Total cholesterol (mg/dL) - High Density Lipoprotein-Cholesterol (HDL-C) (mg/dL) - triglycerides (mg/dL)/5]."},{"outcome_type":"secondary","measure":"Adverse events","time_frame":"basal, 6 and 12 months","description":"Participants were asked about symptoms at clinic visits every 6 months. Standard clinical evaluations and laboratory analyses, including hematologic, renal, and liver function tests, were done every 6 months. Endometrial thickness was evaluated by using ultrasonography at baseline, 6 months, and 1 year. The endometrial thickness was measured in the sagittal plane from 1 basal layer to the other. If the endometrial thickness was 8 mm or greater or if uterine bleeding occurred, hysteroscopy and endometrial biopsy were performed. All unfavorable and unintended clinical effects were considered adverse effects and were evaluated for severity, duration, seriousness, and relation to the study drug and outcome."}]}
{"nct_id":"NCT00847743","start_date":"2007-10-31","phase":"N/A","enrollment":12,"brief_title":"Study on Whether Tart Cherry Juice Can Reduce Oxidative Stress and Inflammation","official_title":"Effects of Tart Cherry Juice on Oxidative Stress and Inflammation in Older Men and Women","primary_completion_date":"2008-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-04-30","last_update":"2009-02-19","description":"Oxidative stress has been linked to many diseases associated with aging, including coronary heart disease and Alzheimer's disease. Antioxidants and special proteins in the body work together to help prevent damage by free radicals. Some studies have indicated that as people age, they are less able to fight off oxidative stress and have increased levels of inflammation. Tart cherries are known to be rich in antioxidants and plant-nutrients. The product we are using in this study is an all-natural tart cherry juice, mixed with apple juice concentrate and containing no additives and no preservatives. We hope to learn whether antioxidant supplementation, such as tart cherry juice, can measurably decrease oxidative damage and inflammation associated with aging.","other_id":"KLRI-2007-03","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":55,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  men and women, ages 55-80y, in good health, with >8 years of education\r\n\r\n          -  non-smoker\r\n\r\n          -  able to give informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  use of anti-oxidant supplements, in excess of a standard multi-vitamins\r\n\r\n          -  current hormone replacement therapy\r\n\r\n          -  any history of significant chronic disease\r\n\r\n          -  uncontrolled hypertension\r\n\r\n          -  body mass index (BMI) > 30 kg/m2\r\n\r\n          -  high physical activity level, as determined by questions on the screening\r\n             questionnaire\r\n\r\n          -  use of anti-inflammatory medication\r\n      ","sponsor":"Kronos Longevity Research Institute","sponsor_type":"Other","conditions":"Oxidative Stress|Antioxidant Capacity|Inflammation","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Tart Cherry Juice","description":"8 fl.oz. twice per day"}],"outcomes":[{"outcome_type":"primary","measure":"plasma F2-isoprostane response to a forearm ischemia-reperfusion challenge."},{"outcome_type":"secondary","measure":"Urinary markers of oxidative damage."}]}
{"nct_id":"NCT00528840","start_date":"2007-10-31","phase":"Phase 3","enrollment":201,"brief_title":"Safety and Efficacy Study of AA4500 (XIAFLEX, Proposed Name) in the Treatment of Advanced Dupuytren's Disease","official_title":"A Phase 3, Open-Label Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Advanced Dupuytren's Disease","primary_completion_date":"2008-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-10-31","last_update":"2017-12-02","description":"This was a Phase 3, 9-month, open-label study conducted in the United States. Subjects with a diagnosis of advanced Dupuytren's disease in a metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint that resulted in a fixed flexion deformity of at least one finger, other than the thumb, that was at least 20 as measured by finger goniometry and was suitable for evaluation and injection were enrolled. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 (NCT00528606) and AUX-CC-859 (NCT00533273)) and 7 non-pivotal studies were evaluated.","other_id":"AUX-CC-856","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subjects with a diagnosis of advanced Dupuytren's disease, with a fixed flexion\r\n             deformity of at least one finger, other than the thumb, that had a contracture at\r\n             least 20, but not greater than 100 for MP (80 for PIP) joints, caused by a palpable\r\n             cord.\r\n\r\n          -  Had a positive \"table top test,\" defined as the inability to simultaneously place the\r\n             affected finger(s) and palm flat against a table top.\r\n\r\n          -  Were nave to AA4500 treatment or had received one or two injections of AA4500 for the\r\n             treatment of advanced Dupuytren's disease in Auxilium Studies AUX-CC-851, AUX-CC-853,\r\n             or AUX-CC-855.\r\n\r\n          -  Were judged to be in good health.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Had a chronic muscular, neurological, or neuromuscular disorder that affected the\r\n             hands.\r\n\r\n          -  Had received treatment for advanced Dupuytren's disease within 90 days of enrollment\r\n             on the joint selected for the initial injection of AA4500, including surgery\r\n             (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of\r\n             verapamil and/or interferon.\r\n\r\n          -  Had a known recent history of stroke, bleeding, a disease process that affected the\r\n             hands, or other medical condition, which in the investigator's opinion, would make the\r\n             subject unsuitable for enrollment in the study.\r\n      ","sponsor":"Endo Pharmaceuticals","sponsor_type":"Industry","conditions":"Advanced Dupuytren's Disease","interventions":[{"intervention_type":"Biological","name":"Biological: collagenase clostridium histolyticum","description":"Up to five injections of AA4500 into cord(s) of the affected hand(s). Each injection was separated by at least 30 days."}],"outcomes":[{"outcome_type":"primary","measure":"Reduction in Contracture to 5° or Less","time_frame":"Within 30 days after the last injection","description":"The Primary Outcome Measure is the percentage of joints that were successfully treated where \"successfully treated\" was defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection"},{"outcome_type":"secondary","measure":"Clinical Improvement After the Last Injection","time_frame":"Baseline; within 30 days after last injection","description":"Clinical Improvement is defined as >=50% percent reduction from baseline in degree of contracture within 30 days after injection."},{"outcome_type":"secondary","measure":"Percent Reduction From Baseline Contracture After the Last Injection","time_frame":"Baseline, within 30 days after last injection","description":"Percent change in degree of contracture measured as 100*(baseline contracture -last available post-injection contracture)/baseline contracture)"},{"outcome_type":"secondary","measure":"Change From Baseline Range of Motion After the Last Injection","time_frame":"Baseline, 30 days after last injection","description":"Change in degree of range of motion measured as last available post-injection range of motion - baseline range of motion."},{"outcome_type":"secondary","measure":"Time to Reach Clinical Success","time_frame":"First evaluation visit on which clinical success is achieved through the Day 30 evaluation","description":"Clinical success is defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection, displayed in post-injection timepoint categories."},{"outcome_type":"secondary","measure":"Clinical Success After the First Injection","time_frame":"Within 30 days after first injection","description":"Clinical Success is defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection."},{"outcome_type":"secondary","measure":"Clinical Improvement After the First Injection","time_frame":"Baseline; within 30 days after first injection","description":"Clinical Improvement is defined as >=50% reduction from baseline in the degree of contracture within 30 days after the first injection"},{"outcome_type":"secondary","measure":"Percent Reduction From Baseline Contracture After the First Injection","time_frame":"Baseline; within 30 days after first injection","description":"Percent change in degree of contracture is measured as 100* (baseline contracture- last available post-injection contracture)/baseline contracture."},{"outcome_type":"secondary","measure":"Change From Baseline Range of Motion After the First Injection","time_frame":"Baseline; within 30 days after first injection","description":"Change in degree of range of motion measured as last available post-injection range of motion-baseline range of motion."}]}
{"nct_id":"NCT00584051","start_date":"2007-10-31","enrollment":90,"brief_title":"Examination of the Role of Atrial Natriuretic Peptide Polymorphisms in Allergic Rhinitis and Asthma Severity","official_title":"The Purpose of This Study is to Examine the Role of Atrial Natriuretic Peptide Polymorphisms in Allergic Rhinitis and Asthma Severity","primary_completion_date":"2009-10-31","study_type":"Observational","rec_status":"Terminated","completion_date":"2009-10-31","last_update":"2018-10-04","description":"Asthma is an inflammatory condition of the airways in the lungs that results in obstruction of airflow in those with the condition. The disease continues to be a major worldwide health care problem and its prevalence continues to increase annually. In 2005, 20 million people were diagnosed with asthma. The disease causes significant morbidity and accounts for 5,000 deaths annually. Between 1980 and 1994 the prevalence of asthma increased 74% in the United States and, in children under age 5, the prevalence increased by 160%. The allergic etiology of airway inflammation associated with asthma is established. Bronchial washings of asthmatic subjects are most often characterized by eosinophils, mast cells, and cytokines that are associated with the Th2 (allergic) phenotype. Similarly, IgE plays a pivotal role in airway inflammation of asthmatic subjects when allergens that cross-link IgE bound to mast cells in the airways cause the release of histamine and other inflammatory mediators. The association of asthma and the IgE mediated allergic phenotype is well established and up to 70% of asthmatics also suffer from allergic disease. Adequately treated asthma often has minimal impact of quality of life but diagnosis and proper treatment is often delayed, resulting in increased missed school days, emergency room visits, and otherwise preventable degradation in quality of life. It would therefore be highly useful to identify a biomarker that can be used to assist in the diagnosis of asthma or to identify subjects at higher risk of developing allergic disease or asthma in the future. Efforts at identifying a genetic marker for the early diagnosis of asthma have been unsuccessful, mainly due to the complexity of the pathogenesis of the disease. Atrial natriuretic factor is a pro-hormone precursor for 4 natriuretic peptide hormones including atrial natriuretic peptide (ANP). ANP's effects on the cardiovascular system are well characterized. Less well understood is the role these hormones play in immune regulation. Recent studies have demonstrated a role for ANP in the regulation of immune function: ANP induces release of histamine from mast cells and macrophages, stimulates migration of neutrophils, enhances the cytotoxic activity of natural killer (NK) cells, and stimulates TNF- production. Human dendritic cells express ANP receptors (GC-a) which polarize CD4+ cells towards a Th2 phenotype. Since allergic rhinitis and asthma are associated with a Th2 phenotype, it is possible that elevated levels of ANP can be used to predict asthma severity or to predict future predilection to atopic disease. There are a number of ANP gene polymorphisms that have been studied and found to be associated with renal disease, heart disease, hypertension and diabetes. Several studies have investigated the potential role of these polymorphisms in cardiovascular disease and have found association between polymorphisms of the ANP gene and left ventricular remodeling, hypertension, renal disease, diabetes, and increased risk of ischemic stroke. To our knowledge, no studies evaluating the role of ANP polymorphisms in allergic disease have been performed. The goal of this research proposal is to evaluate whether ANP levels can be utilized to assist in diagnosis of asthma and in the prediction of asthma severity. Additionally, we will investigate the potential effect of polymorphisms in the ANP gene on asthma severity and thus serve as a useful genetic marker to predict future risk of atopy and asthma.","other_id":"PURCELL","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":40,"population":"The study will include three groups; an asthma group, an allergic rhinitis group, and a\r\n        healthy control group. Participants will be between 18-40 years of age and will meet\r\n        inclusion/exclusion criteria outlined below. The study will continue for a total of 1 year.\r\n        Study subjects will keep a diary of symptoms using a validated asthma subjective\r\n        questionnaire (Juniper). Serum levels of atrial natriuretic peptide and serum IgE, will be\r\n        obtained at the initial visit and then at regular intervals depending on the study group\r\n        (table 1).","criteria":"\n        Inclusion Criteria:\r\n\r\n        Inclusion criteria for asthma group\r\n\r\n          1. Subjects between 18-40 years of age\r\n\r\n          2. History of asthma diagnosed by a physician\r\n\r\n          3. Have a physician documented diagnosis of allergic disease based on detection of\r\n             sensitivity by either skin prick testing or RAST,\r\n\r\n          4. Have a decreased FEV1 with 12% improvement in FEV1 documented within 12 weeks\r\n\r\n        Inclusion criteria for allergic rhinitis group\r\n\r\n          1. Subjects between ages of 18-40\r\n\r\n          2. Have a physician documented history of allergic rhinitis based on prior skin prick\r\n             testing or a positive RAST test.\r\n\r\n        Inclusion criteria for control group\r\n\r\n          1. Subjects between 18-40 years of age\r\n\r\n          2. FEV1 greater than 80% predicted\r\n\r\n          3. No history of wheezing or allergies\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Use of systemic corticosteroids 4 weeks prior to initial visit\r\n\r\n          2. Use of antihistamines 7 days prior to initial visit\r\n\r\n          3. Respiratory infection 2 weeks prior to initial visit\r\n\r\n          4. History of Xolair use or immunotherapy\r\n\r\n          5. Current smoking, alcohol, or substance abuse\r\n\r\n          6. Patients with primary immunodeficiency\r\n\r\n          7. Patients currently on immunosuppressive therapy\r\n\r\n          8. Unable to perform pulmonary function testing\r\n\r\n          9. History of congestive heart failure\r\n\r\n         10. Current cancer diagnosis or undergoing cancer therapy\r\n      ","sponsor":"University of South Florida","sponsor_type":"Other","conditions":"Asthma|Allergic Rhinitis","interventions":{},"outcomes":[{"outcome_type":"secondary","measure":"To determine whether polymorphisms in the ANP gene contribute to the pathogenesis of the allergic condition or asthma.","time_frame":"1YEAR"},{"outcome_type":"primary","measure":"To determine if an overproduction of ANP is associated with atopy and asthma.","time_frame":"1 YEAR"}]}
{"nct_id":"NCT00636480","start_date":"2007-10-31","phase":"Phase 3","enrollment":60,"brief_title":"Preoperative Skin Preparation Evaluation","official_title":"Preoperative Skin Preparation Evaluation of One Test Product With a Positive and a Negative Control","primary_completion_date":"2008-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-03-31","last_update":"2021-05-03","description":"Determine the antimicrobial properties of a proposed new product and an already approved product and a placebo (no drug). Study will be conducted using methods dictated by the FDA.","other_id":"070921-103","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Other","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":16,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Free of dermatoses, cuts, lesions, or other skin disorders on or around the test\r\n             sites; no exposure to topical or systemic antimicrobials, antibiotics, or steroids\r\n             (other than contraceptives, for the fourteen (14) day pre-test conditioning period and\r\n             must agree to abstain from these materials until completion of the study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Exposure of test sites to antimicrobial agents, medicated soaps, medicated shampoos,\r\n             or medicated lotions,\r\n\r\n          -  Use of biocide-treated pools or hot tubs, use of tanning beds, or sunbathing during\r\n             the fourteen(14) day pre-test conditioning period or during the test period;\r\n\r\n          -  Exposure of the test sites to strong detergent, solvents, or other irritants during\r\n             the fourteen (14) day pre-test conditioning period or during the test period;\r\n\r\n          -  Use of systemic or topical antibiotic medications, steroid medications other than\r\n             contraceptives, or any other product known to affect the normal microbial flora of the\r\n             skin during the fourteen ()14) day pre-test conditioning period or during the test\r\n             period;\r\n\r\n          -  Know of allergies to vinyl, latex (rubber), alcohols, metals, inks, or tape adhesives,\r\n             or to common antibacterial agents found in soaps, lotions, or ointments, particularly\r\n             chlorhexidine gluconate, and/or isopropyl alcohol;\r\n\r\n          -  A medical diagnosis of a physical condition, such as a current or recent severe\r\n             illness, asthma, diabetes, hepatitis, an organ transplant, any immunocompromised\r\n             conditions such as AIDS (or HIV positive), mitral valve prolapse, or a requirement to\r\n             take antibiotics prior to dental procedures;\r\n\r\n          -  Pregnancy, plans to become pregnant within the pre-test and test periods of the study,\r\n             or nursing a child;\r\n\r\n          -  Any active skin rashes or breaks in the skin of the test sites;\r\n\r\n          -  A currently active skin disease or inflammatory skin condition, including contact\r\n             dermatitis; showering or bathing within the seventy-two (72) hour period prior to\r\n             sampling; participation in another clinical study in the past thirty (30) days or\r\n             current participation in another clinical study;\r\n\r\n          -  Any medical condition or use of any medications, that, in the opinion of the Study\r\n             Director, should preclude participation;\r\n\r\n          -  Unwillingness to fulfill the performance requirements of the study.\r\n      ","sponsor":"CareFusion","sponsor_type":"Industry","conditions":"Topical Antisepsis","interventions":[{"intervention_type":"Drug","name":"Drug: Chlorhexidine gluconate","description":"Chlorhexidine gluconate (2% w/v) in an aqueous base, 26 ml applicator. Active drug contains alcohol and the placebo contains no drug. Administered topically."},{"intervention_type":"Drug","name":"Drug: ChloraPrep One Step","description":"Administer topically"},{"intervention_type":"Drug","name":"Drug: Sterile saline","description":"0.9% NaCl solution"}],"outcomes":[{"outcome_type":"primary","measure":"3.0 log10 reduction in CFU/cm2 on inguinal sites, and 2.0 log10 reduction in CFU/cm2 on abdominal sites","time_frame":"10 minutes and 6 hours after application of test solutions"}]}
{"nct_id":"NCT00555412","start_date":"2007-10-31","phase":"Phase 1","enrollment":40,"brief_title":"Staccato Loxapine Multidose PK","official_title":"Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Staccato Loxapine for Inhalation in Subjects on Chronic, Stable Antipsychotic Regimens","primary_completion_date":"2007-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-12-31","last_update":"2017-03-15","description":"The objectives of this trial are to assess the safety, tolerability, and pharmacokinetics of multiple inhaled doses of Staccato Loxapine.","other_id":"AMDC-004-102","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria include:\r\n\r\n          1. Male and female subjects between the ages of 18 to 65 years, inclusive.\r\n\r\n          2. Subjects who are on stable, oral, chronic (>2 mos) antipsychotic medication regimen\r\n             and who are able to tolerate the rapid oral dose taper and substitution regimen.\r\n\r\n        Exclusion Criteria include:\r\n\r\n          1. Subjects who are currently treated with injectable depot neuroleptics within one dose\r\n             interval must be excluded.\r\n\r\n          2. Subjects who have received loxapine or amoxapine within the last 30 days must be\r\n             excluded.\r\n\r\n          3. Subjects with a history of allergy or intolerance to dibenzoxazepines (loxapine and\r\n             amoxapine) must be excluded.\r\n\r\n          4. Subjects with a history of movement disorders including Parkinson's disease or a\r\n             history of neuroleptic malignant syndrome must be excluded.\r\n\r\n          5. Subjects who have a history within the past year of drug or alcohol dependence or\r\n             abuse as defined by DSM-4 must be excluded.\r\n      ","sponsor":"Alexza Pharmaceuticals, Inc.","sponsor_type":"Industry","conditions":"Volunteers on Chronic, Stable Antipsychotic Regimens","interventions":[{"intervention_type":"Drug","name":"Drug: A - 10 mg loxapine q 4 h x 3 (30 mg total)","description":"loxapine aerosol inhalation high dose regimen (30 mg total)"},{"intervention_type":"Drug","name":"Drug: B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total)","description":"loxapine aerosol inhalation middle dose regimen (20 mg total)"},{"intervention_type":"Drug","name":"Drug: C - 5 mg loxapine q 4 h x 3 (15 mg total)","description":"loxapine aerosol inhalation low dose regimen (15 mg total)"},{"intervention_type":"Drug","name":"Drug: D - inhaled placebo q 4 h x 3","description":"placebo aerosol inhalation (0 mg total)"}],"outcomes":[{"outcome_type":"primary","measure":"PK parameters: tmax, Cmax, AUClast, AUCinf, ke, t1/2 and clearance will be estimated for each subject and for the population using noncompartmental methods.","time_frame":"48 hours"},{"outcome_type":"secondary","measure":"Plasma concentration-time (PK) profiles will be produced for each subject and a mean PK profile for subjects completing for each dose group","time_frame":"24 hours"},{"outcome_type":"secondary","measure":"Tolerability will be assessed based on treatment emergent adverse events, vital signs, ECG and a visual-analog sedation scale.","time_frame":"24 hours"}]}
{"nct_id":"NCT00525681","start_date":"2007-09-30","phase":"Phase 4","enrollment":18,"brief_title":"Interaction Between Rimonabant and Cyclosporine and Tacrolimus","official_title":"The Effect of Rimonabant Treatment on Cardiovascular Risk Factors in Renal Transplant Recipients -- Pilot Safety Study","primary_completion_date":"2008-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-05-31","last_update":"2014-12-03","description":"The major cause of premature death in renal transplant recipients is cardio-vascular disease. In addition, obesity is becoming a major problem in this patient population. Rimonabant does not only seem to have weight reducing properties but also weight reduction independent effects on insulin sensitivity and endothelial function, two important cardio-vascular risk factors. Rimonabant therefore is an interesting drug for the treatment of transplanted patients. Present data also indicate that rimonabant does not interact with essential immunosuppressive drugs (CsA and Tac) indicating that it most probably is safe to administer to this patient population. However this needs to be investigated in a proper manner.","other_id":"RIMONA-PILOT","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Renal transplant recipient with stable renal function (less than 20% deviation in\r\n             serum creatinine the last 2 months).\r\n\r\n          -  Renal transplant recipient currently on CsA or Tac and prednisolone based\r\n             immunosuppression.\r\n\r\n          -  BMI > 30 kg/m2 or >27 kg/m2 in combination with one or more cardio-vascular risk\r\n             factors.\r\n\r\n          -  > 18 years of age.\r\n\r\n          -  Male patient, or female patient without childbearing potential (surgically sterilized\r\n             or postmenopausal) or, if female of childbearing potential, is not lactating, has a\r\n             negative pregnancy test at screening and is willing to utilize an effective method of\r\n             contraception throughout the study period and for 90 Days following discontinuation of\r\n             the Study Drugs.\r\n\r\n          -  Signed informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Diabetes mellitus\r\n\r\n          -  Severe liver disease.\r\n\r\n          -  Depressive-, anxiety- or sleeping disorders.\r\n\r\n          -  Estimated GFR < 25 ml/min.\r\n\r\n          -  Epilepsy.\r\n\r\n          -  Skin disorders that may influence laser Doppler flowmetry investigations.\r\n\r\n          -  Pregnant or nursing mothers.\r\n\r\n          -  Concomitant treatment with CYP3A4 inhibitors (www.cyp450.no) with interaction\r\n             potential according to the investigator.\r\n      ","sponsor":"University of Oslo School of Pharmacy","sponsor_type":"Other","conditions":"Renal Transplantation","interventions":[{"intervention_type":"Drug","name":"Drug: cyclosporine A","description":"Cyclosporine is dosed twice daily and is individualized as per center practice and kept stable during the study."},{"intervention_type":"Drug","name":"Drug: tacrolimus","description":"Dosing of tacrolimus is given twice daily and individualized as per center practice."}],"outcomes":[{"outcome_type":"primary","measure":"Effect of rimonabant on cylosporine/tacrolimus bioavailablility","time_frame":"2 months"},{"outcome_type":"secondary","measure":"Effect of rimonabant on insulin sensitivity","time_frame":"2 months"}]}
{"nct_id":"NCT00509249","start_date":"2007-09-30","phase":"Phase 2","enrollment":18,"brief_title":"Aflibercept in Treating Patients With Myelodysplastic Syndromes","official_title":"A Phase II Study of VEGF Trap (NSC 724770) in Patients With MDS","primary_completion_date":"2010-12-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2010-12-31","last_update":"2015-01-08","description":"This phase II trial is studying how well aflibercept works in treating patients with myelodysplastic syndromes. Aflibercept may be able to carry cancer-killing substances directly to myelodysplastic syndrome cells. It may also stop the growth of cancer cells by blocking blood flow to the cancer","other_id":"NCI-2009-00180","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients must have histologically or cytologically confirmed myelodysplastic syndromes\r\n             (MDS), including any of the following:\r\n\r\n               -  Secondary MDS\r\n\r\n               -  MDS/myeloproliferative disorders (MPD) (e.g., chronic myelomonocytic leukemia or\r\n                  atypical chronic myeloid leukemia)\r\n\r\n               -  IPSS scores of 0.5 or greater ( INT-1) OR transfusion dependent despite use of\r\n                  growth factors\r\n\r\n               -  No more than 20% blasts in the marrow\r\n\r\n               -  Patients who have not responded after 3 courses of hypomethylating agents\r\n                  (azacitidine or decitabine) OR; who are unable to tolerate hypomethylating agents\r\n                  OR who refused to receive hypomethylating agents are eligible for this study\r\n\r\n          -  ECOG performance status  2 (Karnofsky  60%)\r\n\r\n          -  Total bilirubin  1.5 x upper limit of normal (ULN)\r\n\r\n          -  AST/ALT  2.5 x ULN\r\n\r\n          -  Creatinine  1.5 x ULN OR creatinine clearance  60 mL/min\r\n\r\n          -  Urine protein:creatinine ratio < 1 OR urine protein < 500 mg by 24-hour urine\r\n             collection\r\n\r\n          -  PT INR  1.5\r\n\r\n          -  Patients with PT INR > 1.5 on full-dose anticoagulants (e.g., warfarin) are eligible\r\n             provided both of the following criteria are met:\r\n\r\n               -  Patient has an in-range INR (usually between 2 and 3) and is on a stable dose of\r\n                  oral anticoagulant or low molecular weight heparin\r\n\r\n               -  Patient has no active bleeding or pathological condition that carries a high risk\r\n                  of bleeding (e.g., tumor involving major vessels or known varices)\r\n\r\n          -  Not pregnant or nursing\r\n\r\n          -  Fertile patients must use effective contraception during and for at least 6 months\r\n             after completion of study treatment\r\n\r\n          -  Prior DNA-demethylating agent therapy or lenalidomide therapy allowed\r\n\r\n          -  Prior treatment with other molecular agents, such as thalidomide, valproic acid, or\r\n             imatinib mesylate allowed\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Evidence of active malignancies other than squamous cell or basal cell carcinoma of\r\n             the skin\r\n\r\n          -  Known hypersensitivity to Chinese hamster ovary cell products or other recombinant\r\n             human antibodies\r\n\r\n          -  History of allergic reactions attributed to compounds of similar chemical or biologic\r\n             composition to agents used in the study\r\n\r\n          -  Serious or non-healing wound, ulcer, or bone fracture\r\n\r\n          -  History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess\r\n             within the past 28 days\r\n\r\n          -  Significant traumatic injury within the past 28 days\r\n\r\n          -  Clinically significant cardiovascular disease, including any of the following:\r\n\r\n               -  History of cerebrovascular accident (CVA) within the past 6 months\r\n\r\n               -  Uncontrolled hypertension, defined as blood pressure > 150/100 mm Hg or systolic\r\n                  BP > 180 mm Hg if diastolic blood pressure < 90 mm Hg (on at least 2 repeated\r\n                  determinations on separate days) within the past 3 months\r\n\r\n               -  Myocardial infarction or unstable angina within the past 6 months\r\n\r\n               -  New York Heart Association class III or IV congestive heart failure, serious\r\n                  cardiac arrhythmia requiring medication, or unstable angina pectoris within the\r\n                  past 6 months\r\n\r\n          -  Clinically significant peripheral vascular disease within the past 6 months\r\n\r\n          -  Pulmonary embolism, deep vein thrombosis (DVT), or other thromboembolic event within\r\n             the past 6 months\r\n\r\n          -  Evidence of bleeding diathesis or coagulopathy\r\n\r\n          -  Concurrent uncontrolled illness including, but not limited to, ongoing or active\r\n             infection or psychiatric illness/social situation that would limit compliance with\r\n             study requirements\r\n\r\n          -  Prior cytotoxic chemotherapy for MDS\r\n\r\n          -  Molecular therapy or immunosuppressive agents (including steroids) within the past 3\r\n             weeks\r\n\r\n          -  Other prior antiangiogenesis agents\r\n\r\n          -  Coronary artery bypass graft (CABG) within the past 6 months\r\n\r\n          -  Valproic acid should be discontinued at least 24 hours before aflibercept\r\n             administration, unless needed for seizure control\r\n\r\n          -  Major surgical procedure or open biopsy within the past 28 days\r\n\r\n          -  Core biopsy (other than bone marrow biopsy) within the past 7 days\r\n\r\n          -  Anticipation of need for major surgical procedures during the course of the study\r\n\r\n          -  Patients may not be receiving any other investigational agents\r\n      ","sponsor":"National Cancer Institute (NCI)","sponsor_type":"NIH","conditions":"Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative|Chronic Myelomonocytic Leukemia|de Novo Myelodysplastic Syndromes|Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable|Previously Treated Myelodysplastic Syndromes|Secondary Myelodysplastic Syndromes","interventions":[{"intervention_type":"Other","name":"Other: laboratory biomarker analysis","description":"Correlative studies"},{"intervention_type":"Biological","name":"Biological: ziv-aflibercept","description":"Given IV"},{"intervention_type":"Other","name":"Other: pharmacological study","description":"Correlative studies"}],"outcomes":[{"outcome_type":"primary","measure":"Hematological Response Rate","time_frame":"Up to 3 years","description":"Complete Response (CR): repeat bone marrow (BM) shows <5% myeloblasts, and peripheral blood values lasting ≥ 2 months of hemoglobin (hgb) (>110 g/L), neutrophils (≥1.0x10^9/L), platelets (≥100x10^9/L), blasts (0%) and no dysplasia. Partial Response (PR): same as CR for peripheral blood except BM shows blasts decrease by ≥ 50% but still > 5% or a less advanced FAB classification from pretreatment. Hematological response=CR+PR."}]}
{"nct_id":"NCT00532441","start_date":"2007-09-30","phase":"Phase 2","enrollment":25,"brief_title":"Erlotinib in Combination With Docetaxel in Advanced Hepatocellular and Biliary Tract Carcinomas","official_title":"Phase II Trial of Erlotinib in Combination With Docetaxel in Advanced Hepatocellular and Biliary Tract Carcinomas: Hoosier Oncology Group GI06-101","primary_completion_date":"2010-08-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2010-08-31","last_update":"2016-02-12","description":"An unmet medical need exists for the successful therapy of patients with advanced hepatocellular and biliary tract malignances, with few and short lived disease responses to chemotherapy for both advanced stage hepatic and biliary carcinomas. Pre-clinical data shows cooperative antitumor activity between an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor and taxanes. The efficacy of erlotinib in combination with docetaxel will be assessed in this trial.","other_id":"GI06-101","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histological or cytological proof of hepatocellular or biliary tract carcinomas, not\r\n             amenable to curative resection or transplantation.\r\n\r\n          -  Prior cancer treatment completed at least 30 days prior to being registered for\r\n             protocol therapy and recovered from the acute toxicity effects of the regimen.\r\n\r\n          -  Patients may have had radiofrequency ablation, cryosurgery or embolization, but must\r\n             have documented progressive disease with the involved lesion, or at least one\r\n             previously untreated lesion.\r\n\r\n          -  Patients may have had  2 prior chemotherapy regimens.\r\n\r\n          -  Prior radiation therapy allowed to < 25% of the bone marrow at least 30 days prior to\r\n             being registered for protocol therapy.\r\n\r\n          -  Patients with biliary obstruction must have percutaneous transhepatic drainage or\r\n             endoscopic stent placement prior to starting study treatment.\r\n\r\n          -  Patients with a history of malignancy are eligible provided they have been curatively\r\n             treated and demonstrate no evidence for recurrence of that cancer.\r\n\r\n          -  Peripheral neuropathy  grade 1.\r\n\r\n          -  Patients must agree to abstain from frozen or fresh grapefruit or grapefruit juice for\r\n             5 days prior to, and during treatment.\r\n\r\n          -  Patients must be willing to use an effective method of contraception (hormonal or\r\n             barrier method of birth control; abstinence) while on treatment and for a 12 week\r\n             period thereafter.\r\n\r\n          -  Females of childbearing potential must have a negative pregnancy test within 7 days\r\n             prior to being registered for protocol therapy.\r\n\r\n          -  Written informed consent and HIPAA authorization for release of personal health\r\n             information.\r\n\r\n          -  Age  18 years at time of consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  No previous treatment with EGFR inhibitors.\r\n\r\n          -  No treatment with any investigational agent within 30 days prior to being registered\r\n             for protocol therapy.\r\n\r\n          -  No symptomatic brain metastasis. A subject with prior brain metastasis may be\r\n             considered if they have completed their treatment for brain metastasis, no longer\r\n             require corticosteroids, and are asymptomatic.\r\n\r\n          -  No Child-Pugh B or C liver cirrhosis.\r\n\r\n          -  No active corneal erosions or history of abnormal corneal sensitivity test.\r\n\r\n          -  No history of aneurysm or arteriovenous malformation.\r\n\r\n          -  No hemorrhage/bleeding event > CTCAE Grade 3 within 30 days prior to begin registered\r\n             for protocol therapy.\r\n\r\n          -  No clinically significant infections as judged by the treating investigator.\r\n\r\n          -  No condition that impairs patient's ability to swallow whole pills.\r\n\r\n          -  No history of hypersensitivity to docetaxel or other drugs formulated with polysorbate\r\n             80.\r\n\r\n          -  Females must not be breastfeeding.\r\n\r\n          -  Patients who cannot avoid the following medications will be ineligible for the trial:\r\n             midazolam, anti-mycotic agents (ketoconazole and related compounds), macrolide\r\n             antibiotics (erythromycin and related compounds), nifedipine, phenobarbital,\r\n             phenytoin, carbamazepine, and rifampin (induction) and anti-retrovirals (including\r\n             ritonavir, saquinavir).\r\n      ","sponsor":"Gabi Chiorean, MD","sponsor_type":"Other","conditions":"Hepatocellular Carcinoma","interventions":[{"intervention_type":"Drug","name":"Drug: Erlotinib","description":"Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28"},{"intervention_type":"Drug","name":"Drug: Docetaxel","description":"Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15"}],"outcomes":[{"outcome_type":"primary","measure":"16 Weeks Progression-free Survival","time_frame":"Start of treatment until disease progression per RECIST criteria up to 16 weeks","description":"To determine the rate of progression-free survival (PFS) at 16 weeks for the combination therapy of erlotinib and docetaxel for subjects in the Biliary stratum, per RECIST criteria. Progressive disease is defined as at least a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum recorded since the treatment started or the appearance of one or more new lesions."},{"outcome_type":"secondary","measure":"Response Rate","time_frame":"18 months","description":"Determine the Response Rate Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0)"},{"outcome_type":"secondary","measure":"Overall Survival","time_frame":"18 Months","description":"Determine Overall Survival"}]}
{"nct_id":"NCT00407459","start_date":"2007-09-30","phase":"Phase 2","enrollment":77,"brief_title":"Phase II Study of Bevacizumab, Pemetrexed and Carboplatin as First-Line Therapy in Malignant Pleural Mesothelioma","official_title":"Phase II Study of the Combination of Bevacizumab Plus Pemetrexed and Carboplatin as First-line Therapy in Patients With Malignant Pleural Mesothelioma","primary_completion_date":"2010-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-11-30","last_update":"2011-09-02","description":"The primary objective is to assess antitumor activity of the combination of bevacizumab, pemetrexed and carboplatin, in terms of time to progression.","other_id":"ONC-2006-003","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically proven malignant pleural mesothelioma, inoperable, non previously\r\n             treated with chemotherapy including intracavitary administration\r\n\r\n          -  PS 0-1\r\n\r\n          -  Measurable and/or evaluable lesions according to RECIST criteria\r\n\r\n          -  Adequate organ function\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Uncontrolled hypertension\r\n\r\n          -  Evidence of bleeding diathesis or coagulopathy\r\n\r\n          -  Pregnancy or breast-feeding\r\n      ","sponsor":"Armando Santoro, MD","sponsor_type":"Other","conditions":"Mesothelioma","interventions":[{"intervention_type":"Drug","name":"Drug: Bevacizumab, Pemetrexed, Carboplatin","description":"Bevacizumab: 15 mg/kg intravenous infusion over 30 to 90 minutes, following chemotherapy, on Day 1 every 3 weeks\r\nPemetrexed: 500 mg/m2 intravenous infusion over 10 minutes on Day 1 every 3 weeks\r\nCarboplatin: AUC 5 intravenous infusion over 1 hour on Day 1 every 3 weeks"}],"outcomes":[{"outcome_type":"secondary","measure":"Response rate (RR) assessed according to modified RECIST criteria for Malignant Pleural Mesothelioma.","time_frame":"Two months after the end of enrollment"},{"outcome_type":"primary","measure":"Time to progression (TTP) from first day of treatment until first observation of disease progression or death due to any cause or the last date the patient was known to be progression free or alive.","time_frame":"At the end of study"},{"outcome_type":"secondary","measure":"Overall survival (OS) computed as the time between the first day of treatment and the date of death or the last date the patient was known to be alive.","time_frame":"At the end of study"}]}
{"nct_id":"NCT00544596","start_date":"2007-09-30","phase":"Phase 1","enrollment":27,"brief_title":"R-(-)-Gossypol Acetic Acid, Cisplatin, and Etoposide in Treating Patients With Advanced Solid Tumors or Extensive Stage Small Cell Lung Cancer","official_title":"A Phase 1 Study of R-(-)-Gossypol (AT-101) in Combination With Cisplatin and Etoposide in Patients With Advanced Solid Tumors and Extensive-Stage Small Cell Lung Cancer","primary_completion_date":"2013-07-31","study_type":"Interventional","rec_status":"Completed","last_update":"2014-04-02","description":"This phase I trial is studying the side effects and best dose of R-(-)-gossypol acetic acid when given together with cisplatin and etoposide in treating patients with advanced solid tumors or extensive stage small cell lung cancer. R-(-)-gossypol acetic acid may stop the growth of cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving R-(-)-gossypol acetic acid together with combination chemotherapy may help kill more tumor cells.","other_id":"NCI-2009-00273","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  In the dose-escalation cohorts: patients must have histologically confirmed malignancy\r\n             that is metastatic or unresectable and for which standard curative or palliative\r\n             measures do not exist or are no longer effective; in the MTD expansion cohort:\r\n             patients must have histologically or cytologically confirmed extensive-stage small\r\n             cell lung cancer\r\n\r\n          -  Patients must not have received prior therapy that inhibits the B-cell lymphoma 2\r\n             (Bcl-2) family\r\n\r\n          -  Patients with small cell lung cancer may have received prior prophylactic cranial\r\n             irradiation\r\n\r\n          -  Prior whole brain radiotherapy allowed for patients with brain metastases provided\r\n             they have stable/improved lesions for at least 1 month following treatment, no\r\n             neurological symptoms and not require corticosteroids; an magnetic resonance imaging\r\n             (MRI) of the brain or computed tomography (CT) scan of the head must be performed at\r\n             baseline if patient has a history of brain metastases\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)\r\n\r\n          -  Life expectancy of greater than 12 weeks\r\n\r\n          -  Leukocytes >= 3,000/mcL\r\n\r\n          -  Absolute neutrophil count >= 1,500/mcL\r\n\r\n          -  Platelets >= 100,000/mcL\r\n\r\n          -  Total bilirubin < 1.5 mg/dL\r\n\r\n          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase\r\n             [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT])\r\n             =< 2.5 x institutional upper limit of normal\r\n\r\n          -  Serum creatinine < 1.5 x institutional upper limit of normal OR\r\n\r\n          -  Creatinine clearance >= 45 mL/min/1.73 m^2, as calculated by Cockroft-Gault formula,\r\n             for patients with creatinine levels above institutional normal; a 24 hour urine\r\n             collection and creatinine clearance can be measured if indicated\r\n\r\n          -  The effects of AT-101 on the developing human fetus are unknown; for this reason and\r\n             because other therapeutic agents used in this trial are known to be teratogenic, women\r\n             of child-bearing potential and men must agree to use adequate contraception (hormonal\r\n             or barrier method of birth control; abstinence) prior to study entry, for the duration\r\n             of study participation, and for at least one month following the last dose of AT-101;\r\n             should a woman become pregnant or suspect she is pregnant while participating in this\r\n             study, she should inform her treating physician immediately\r\n\r\n          -  Patients should display the ability to understand and the willingness to sign a\r\n             written informed consent document\r\n\r\n          -  Female patients of child bearing potential must not be pregnant\r\n\r\n          -  Patients must have measurable or evaluable disease\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients without small cell lung cancer who have had chemotherapy, radiotherapy or\r\n             hormonal therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to\r\n             entering the study or those who have not recovered (=< grade 1) from clinically\r\n             significant adverse events due to agents administered more than 4 weeks earlier; prior\r\n             treatment with a platinum-based chemotherapy regimen in combination with thoracic\r\n             radiation therapy is allowed for patients with ES-SCLC provided that recurrence of the\r\n             SCLC occurred more than 6 months from definitive therapy for limited-stage small cell\r\n             lung cancer; no other prior chemotherapy is allowed for the patients with ES-SCLC\r\n\r\n          -  Failure to recover fully (as judged by the investigator) from prior surgical\r\n             procedures\r\n\r\n          -  Concurrent treatment with an investigational agent other than the investigational\r\n             agent(s) used in this study OR treatment within 4 weeks of study entry with any\r\n             investigational agent(s) or device(s)\r\n\r\n          -  Any prior use of racemic gossypol or AT-101\r\n\r\n          -  History of allergic reactions attributed to compounds of similar chemical or biologic\r\n             composition to AT-101 or other agents used in study\r\n\r\n          -  Requirement for routine use of hematopoietic growth factors (including granulocyte\r\n             colony stimulating factor, granulocyte macrophage colony stimulating factor, or\r\n             interleukin-11) or platelet transfusions to maintain absolute neutrophil counts or\r\n             platelets counts above the required thresholds for study entry; if patient requires\r\n             routine use of erythropoietin, eligibility at investigator discretion\r\n\r\n          -  Any condition (e.g., gastrointestinal tract disease resulting in an inability to take\r\n             oral medication or a requirement for IV alimentation, prior surgical procedures\r\n             affecting absorption, or active peptic ulcer disease) that impairs their ability to\r\n             swallow and retain AT-101 tablets\r\n\r\n          -  Patients with malabsorption syndrome, disease significantly affecting gastrointestinal\r\n             function, or resection of the stomach or small bowel are excluded; subjects with\r\n             ulcerative colitis, inflammatory bowel disease, or a partial or complete small bowel\r\n             obstruction are also excluded\r\n\r\n          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active\r\n             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac\r\n             arrhythmia, or psychiatric illness/social situations that would limit compliance with\r\n             study requirements\r\n\r\n          -  Pregnant women are excluded from this study because the effects of AT-101 on the\r\n             developing human fetus are unknown, but could potentially include teratogenic or\r\n             abortifacient effects; because there is an unknown but potential risk for adverse\r\n             events in nursing infants secondary to treatment of the mother with AT-101,\r\n             breastfeeding should be discontinued if the mother is treated with AT-101; these\r\n             potential risks may also apply to other agents used in this study\r\n\r\n          -  Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral\r\n             therapy are ineligible because of the potential for pharmacokinetic interactions with\r\n             AT-101 or other agents used in this study; in addition, these patients are at\r\n             increased risk of lethal infections when treated with marrow-suppressive therapy;\r\n             appropriate studies will be undertaken in patients receiving combination\r\n             antiretroviral therapy when indicated\r\n\r\n          -  Patients with > grade 2 symptomatic hypercalcemia (based on investigator discretion)\r\n      ","sponsor":"National Cancer Institute (NCI)","sponsor_type":"NIH","conditions":"Extensive Stage Small Cell Lung Cancer|Unspecified Adult Solid Tumor, Protocol Specific","interventions":[{"intervention_type":"Drug","name":"Drug: R-(-)-gossypol acetic acid","description":"Given orally"},{"intervention_type":"Drug","name":"Drug: cisplatin","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: etoposide","description":"Given IV"}],"outcomes":[{"outcome_type":"primary","measure":"Toxicity and tolerability of R-(-)-gossypol acetic acid in combination with cisplatin and etoposide in terms of types and severities by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0","time_frame":"Assessed up to 30 days after completion of study treatment","description":"The 95% confidence interval will be obtained."},{"outcome_type":"primary","measure":"Response as assessed by RECIST criteria","time_frame":"Assessed up to 30 days after completion of study treatment","description":"Responses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease. A 95% confidence interval of the overall response rate will be constructed."},{"outcome_type":"secondary","measure":"Pharmacokinetics of R-(-)-gossypol acetic acid in combination with cisplatin and etoposide","time_frame":"Days 1 and 2 of courses 1 and 2","description":"Summarized by dose level with simple summary statistics: means, medians, ranges, and standard deviations."}]}
{"nct_id":"NCT00654797","start_date":"2007-09-30","phase":"Phase 2","enrollment":200,"brief_title":"Improving Blood Glucose Control With a Computerized Decision Support Tool: Phase 2","official_title":"Clinical Process Improvement With A Bedside Computerized Insulin Therapy Protocol For Blood Glucose Control (eProtocol-insulin) in Adult And Pediatric Intensive Care Unit Patients-Second Phase (Phase-2): Distribution and Implementation of Validated eProtocol-insulin in Nave ICUs","primary_completion_date":"2017-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2018-12-31","last_update":"2015-02-26","description":"The Purpose of this study is to: 1. Introduce the refined, validated, and safe computerized bedside decision support tool for blood glucose management in critically ill adult and pediatric ICU patients that was studied in Phase 1 into a second group of nave ICUs, none of which participated in eProtocol-insulin development, refinement or validation 2. Monitor how often low blood sugar levels occur during use of the bedside tool. 3. Determine how the computerized tool effects the workload of the ICU nurses.","other_id":"N01-HC-45210-2","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":0.08333,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Pediatric ICU: Proposed indications by pediatric clinicians at participating ICUs for\r\n             glucose control in their ICUs would include patients who require mechanical\r\n             ventilation for greater than 24 hours and/or require a vasoactive infusion (e.g.\r\n             dopamine >3 mg/kg/min, dobutamine, epinephrine, or vasopressin).\r\n\r\n          2. Adult ICUs: Proposed indications by clinicians in participating ICUs for glucose\r\n             control in participating adult ICUs include critically ill patients with an\r\n             anticipated ICU length of stay of 3 or more days.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Pregnancy (negative pregnancy test required for females of child-bearing age)\r\n\r\n          2. Age less than one month\r\n\r\n          3. Inborn errors of metabolism that the clinician suspects will affect glucose\r\n             homeostasis\r\n\r\n          4. Acute or chronic liver disease with any documented episode of blood or plasma glucose\r\n             <60 mg/dl within the 24 hours prior to study entry\r\n\r\n          5. Diabetic Ketoacidosis (critically ill patients with insulin dependent diabetes not in\r\n             ketoacidosis will be eligible if attending physicians intend to use intravenous\r\n             insulin as part of ordinary care)\r\n\r\n          6. Severe chronic liver disease (Child-Pugh score >10)\r\n      ","sponsor":"Intermountain Health Care, Inc.","sponsor_type":"Other","conditions":"Critically Ill|Hyperglycemia","interventions":[{"intervention_type":"Procedure","name":"Procedure: glucose control with computer generated recommendations","description":"Insulin dosing will be recommended by the computer tools based on subject glucose values. Bedside clinicians will have the ablity to accept or reject the suggested dose."}],"outcomes":[{"outcome_type":"primary","measure":"The primary outcome variable for feasibility during Phase-2 will be the acceptability of the eProtocol-insulin instructions (compliance of bedside clinicians with instructions). Proportion of glucose values < 40 mg/dl.","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Proportion of glucose determinations between 70 and 110 mg/dl (3.9-6.1 mMol/L) (efficacy)","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Time to reach the 80-110 mg/dl target","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Nursing perception of workload in comparison to ordinary care (efficacy and feasibility)","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Proportion of glucose values 41-60 mg/dl","time_frame":"1 year"}]}
{"nct_id":"NCT01017003","start_date":"2007-09-30","phase":"Phase 1","enrollment":14,"brief_title":"Pharmacokinetic Study With Colchicine in Healthy Volunteers","official_title":"An Open Label, Two Period, Sequential, Single Dose and Multiple Dose Pharmacokinetic Study With 0.6mg Colchicine Tablets in Healthy Volunteers","primary_completion_date":"2007-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-12-31","last_update":"2009-11-20","description":"This open label, single group, sequential dose study will compare the single dose pharmacokinetics of colchicine 0.6 mg given orally to colchicine pharmacokinetics after 10 days of a standard prophylactic dose (0.6 mg every 12 hours) in healthy volunteers.","other_id":"MPC-004-07-1004","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Completion of the screening process within 28 days prior to Period I dosing\r\n\r\n          -  Healthy non-smoking, non-obese adult men and women volunteers between the ages of 18\r\n             to 45 years of age, weighing at least 110 with a body mass index of 18-30kg/m2\r\n\r\n          -  Women must be postmenopausal, surgically sterile, commit to abstinence from\r\n             heterosexual sexual contact or use two methods of contraception.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnant or lactating\r\n\r\n          -  Use of any investigational drug within 28 days prior to Period I dosing.\r\n\r\n          -  Presence or history of a clinically significant disorder involving the cardiovascular,\r\n             respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or\r\n             neurologic system(s) or psychiatric disease as determined by the clinical\r\n             investigator(s)\r\n\r\n          -  Positive screen for human immunodeficiency virus (HIV), hepatitis B surface antigen\r\n             (HbsAg), or hepatitis C virus (HCV)\r\n\r\n          -  Clinical laboratory test values outside the accepted reference range and when\r\n             confirmed on re-examination.\r\n\r\n          -  Any clinically significant illness during the 4 weeks prior to Period I dosing (as\r\n             determined by the clinical investigators)\r\n\r\n          -  Use of any systemic prescription medication in the 14 days prior to Period I dosing\r\n\r\n          -  History of any allergy(s) including allergy to colchicine or related drugs.\r\n\r\n          -  History of drug or alcohol addiction or abuse within the past year or a positive drug\r\n             abuse screen\r\n\r\n          -  Currently or recent (within 6 months) use of tobacco products prior to dose\r\n             administration\r\n\r\n          -  Donation of greater than 150 mL of blood within 28 days or plasma within 14 days prior\r\n             to period I dosing\r\n      ","sponsor":"Mutual Pharmaceutical Company, Inc.","sponsor_type":"Industry","conditions":"Pharmacokinetics","interventions":[{"intervention_type":"Drug","name":"Drug: colchicine tablets","description":"0.6mg colchicine tablet"},{"intervention_type":"Drug","name":"Drug: colchicine tablets","description":"0.6mg q12 hours for 10 days"}],"outcomes":[{"outcome_type":"primary","measure":"Maximum Serum Concentration (Cmax)","time_frame":"Pharmacokinetic samples collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing","description":"maximum serum concentration measured after a single oral dose in fasted healthy adults and after a single oral dose in fasted healthy adults at steady state for comparison of the two conditions"},{"outcome_type":"primary","measure":"Area Under the Concentration Versus Time Curve From Time Zero to the Time of the Last Measured Level.","time_frame":"0.0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 36, 48, 72, and 96 hours after dosing","description":"Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (t), calculated using the linear trapezoidal rule."},{"outcome_type":"primary","measure":"Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC 0-inf)","time_frame":"0.0, 0.5, 1,1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing","description":"The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant."}]}
{"nct_id":"NCT00538928","start_date":"2007-09-30","phase":"N/A","enrollment":120,"brief_title":"Extrapulmonary Interventional Ventilatory Support in Severe Acute Respiratory Distress Syndrome (ARDS)","official_title":"Extrapulmonary Interventional Ventilatory Support for Lung Protection in Severe Acute Respiratory Distress - a Prospective Randomized Multi Centre Study","primary_completion_date":"2011-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-01-31","last_update":"2011-03-02","description":"A prospective, randomized study will be performed investigating the effects of a pumpless extracorporeal interventional lung assist [iLA] on the implementation of a lung-protective ventilatory strategy in patients with acute respiratory distress syndrome [ARDS] with a PaO2/FiO2 ratio < 200. The duration of ventilation, intensive care and hospital stay and in-hospital mortality will be investigated.","other_id":"KKS 4012-001-07","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  The trial subjects are patients aged 18 years or older who have developed severe ARDS.\r\n             Following the American-European Consensus Conference on ARDS, severe ARDS is defined\r\n             as an oxygenation index (PaO2/FIO2) < 200 mmHg. These parameters must be present for a\r\n             duration of at least 2 hours.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  age < 18 years\r\n\r\n          -  decompensated heart insufficiency\r\n\r\n          -  acute coronary syndrome\r\n\r\n          -  severe chronic obstructive pulmonary disease\r\n\r\n          -  advanced tumour conditions with life expectancy < 6 months\r\n\r\n          -  chronic dialysis treatment\r\n\r\n          -  lung transplant patients\r\n\r\n          -  proven Heparin-induced thrombocytopenia (HIT)\r\n\r\n          -  morbid obesity (BMI >) 40\r\n\r\n          -  Child Class B and C cirrhosis of the liver, acute fulminant hepatic failure\r\n\r\n          -  severe peripheral arterial occlusive disease (pAVK III - IV), absence of limb doppler\r\n             pulse\r\n\r\n          -  brain injury (GCS < 9 + CT pathology)\r\n      ","sponsor":"University of Regensburg","sponsor_type":"Other","conditions":"Acute Respiratory Distress Syndrome","interventions":[{"intervention_type":"Other","name":"Other: lung protective ventilation","description":"tidal volume 6 ml/kg ideal body weight"}],"outcomes":[{"outcome_type":"primary","measure":"Ventilator free days within 28 days after enrollment","time_frame":"28 days"},{"outcome_type":"secondary","measure":"hospital mortality, organ-failure free days, pulmonary gas exchange","time_frame":"28 days - 60 days"}]}
{"nct_id":"NCT00600145","start_date":"2007-09-30","phase":"N/A","enrollment":0,"brief_title":"Dose Response of Mirtazapine to Methamphetamine Induced Interest, Mood Elevation and Reward","official_title":"Dose Response of Mirtazapine to Methamphetamine Induced Interest, Mood Elevation and Reward","primary_completion_date":"2009-12-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2010-07-31","last_update":"2011-04-27","description":"The primary purpose of this study is to determine if Mirtazapine will produce a decrease in interest in the drug, a decrease in mood elevation, and/or a decrease in reward when given before methamphetamine compared to placebo. Participants will be screened with a psychiatric interview, medical history and physical, laboratory tests, drug of abuse screen and, if female, a urine pregnancy test. They will be provided written informed consent. They will be studied in a within-subjects examination of the subjective mood responses of mirtazapine and methamphetamine. Interactions between methamphetamine and mirtazapine will be assessed by pharmacokinetic studies. Each participant will be introduced to rating scales and cognitive tasks described below. Participants will remain in the research unit for 5 hours on each day that they receive study medication or placebo. They will spend five days in total on the research unit, one day separated by at least one day; then in two day blocks separated by at least one day from another two day block. A venous catheter will be placed for blood draws. Blood pressures and heart rates will be recorded and assessed. Participants will be randomized and double blinded to receive either placebo or mirtazapine orally two hours prior to the administration of randomized and double blinded methamphetamine or placebo in order to have the peak effects of the drugs overlap. VAS-mood, ARCI, GRS, POMS and POMS-E, neurocognitive tasks Trails A and B and Symbol digits modalities test will be administered prior to the mirtazapine or placebo dose, and repeated after the administration of methamphetamine or placebo. After the administration of methamphetamine or placebo, vital signs will be assessed every 15 minutes and the measures will be repeated until 120 minutes have passed from the initial dose of methamphetamine or placebo. Blood will be drawn at one, three and four hour marks for pharmacokinetic testing. This will be repeated on each testing day.","other_id":"13222","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18 -45 years old\r\n\r\n          -  healthy human volunteers\r\n\r\n          -  no history of pre-existing physical (including cardiovascular) illness\r\n\r\n          -  no history of drug abuse or dependence (defined below)\r\n\r\n          -  ability to read and write\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  pregnant\r\n\r\n          -  any psychotropic medication\r\n\r\n          -  criteria for active substance abuse or dependence based on the DSM-IV: For substance\r\n             abuse: A maladaptive pattern of substance use leading to clinically significant\r\n             impairment or distress, as manifested by one (or more) of the following, occurring\r\n             within a 12-month period:\r\n\r\n               1. recurrent substance use resulting in a failure to fulfill major role obligations\r\n                  at work, school, home (e.g., repeated absences or poor work performance related\r\n                  to substance use; substance-related absences, suspensions, or expulsions from\r\n                  school; neglect of children or household)\r\n\r\n               2. recurrent substance use in situations in which it is physically hazardous (e.g.,\r\n                  driving an automobile or operating a machine when impaired by substance use)\r\n\r\n               3. recurrent substance-related legal problems (e.g., arrests for substance-related\r\n                  disorderly conduct)\r\n\r\n               4. continued substance use despite having persistent or recurrent social or\r\n                  interpersonal problems caused or exacerbated by the effects of the substance\r\n                  (e.g., arguments with spouse about consequences of intoxication, physical fights)\r\n\r\n          -  The symptoms have never met the criteria for Substance Dependence for this class of\r\n             substances.\r\n\r\n          -  For substance dependence: A maladaptive pattern of substance use, leading to\r\n             clinically significant impairment or distress, as manifested by three (or more) of the\r\n             following, occurring at any time in the same 12-month period:\r\n\r\n               1. tolerance, as defined by either of the following:\r\n\r\n                    1. a need for markedly increased amounts of the substance to achieve\r\n                       intoxication or desired effect\r\n\r\n                    2. markedly diminished effect with continued use of the same amount of\r\n                       substance\r\n\r\n               2. withdrawal, as manifested by either of the following:\r\n\r\n                    1. the characteristic withdrawal syndrome for the substance\r\n\r\n                    2. the same (or a closely related) substance is taken to relieve or avoid\r\n                       withdrawal symptoms\r\n\r\n               3. the substance is often taken in larger amounts or over a longer period than was\r\n                  intended\r\n\r\n               4. there is a persistent desire or unsuccessful efforts to cut down or control\r\n                  substance use\r\n\r\n               5. a great deal of time is spent in activities to obtain the substance, use the\r\n                  substance, or recover from its effects\r\n\r\n               6. important social, occupational or recreational activities are given up or reduced\r\n                  because of substance use\r\n\r\n               7. the substance use is continued despite knowledge of having a persistent or\r\n                  recurrent physical or psychological problem that is likely to have been caused or\r\n                  exacerbated by the substance (e.g., continued drinking despite recognition that\r\n                  an ulcer was made worse by alcohol consumption) on any stimulant medication\r\n                  including:\r\n\r\n                    -  Amphetamine (Adderall, Adderall XR)\r\n\r\n                    -  Dextroamphetamine (Dexedrine)\r\n\r\n                    -  Methamphetamine (Desoxyn)\r\n\r\n                    -  Dexmethylphenidate (Focalin, Focalin XR)\r\n\r\n                    -  Diethylpropion (Tenuate, Tenuate Dospan)\r\n\r\n                    -  Methylphenidate (Metadate CD, Ritalin LA, Methylin, Ritalin, Metadate\r\n                       ER, Ritalin SR, Methylin ER, Daytrana, Concerta)\r\n\r\n                    -  Pemoline (Cylert)\r\n\r\n                    -  Benzphetamine (Didrex)\r\n\r\n                    -  Phendimetrazine (Adipost, Bontril, Melfiat, Prelu-2, X-Trozine LA,\r\n                       Bontril PDM, Obezine, Obezine caplets) \r\n\r\n                    -  Phentermine (Ionamin, Phentride, Teramine, Adipex-P)\r\n\r\n                    -  Sibutramine (Meridia)\r\n\r\n                    -  Caffeine (No Doz, Quick-Pep, Vivarin, Caffedrine,Caffeine and sodium\r\n                       benzoate inj, Cafcit)\r\n\r\n                    -  Doxapram (Dopram)\r\n\r\n                    -  Modafinil (Provigil)\r\n\r\n                    -  Cocaine\r\n\r\n                    -  MDMA (Ecstasy)\r\n\r\n                    -  MDA\r\n\r\n          -  history of hypertension (BP > 140/90 mm Hg) or systolic hypotension (BP <90/75 mm Hg).\r\n\r\n          -  Subjects with resting pulse rate >90/min.\r\n\r\n          -  any active medical illness\r\n\r\n          -  Subjects known to have clinically significant medical conditions, as determined by\r\n             complete physical examination, or, a past or current history of the following\r\n             conditions (including but not limited to):\r\n\r\n          -  cerebrovascular accident or transient ischemic attack;\r\n\r\n          -  ischemic heart disease or myocardial infarction;\r\n\r\n          -  symptomatic coronary artery disease or peripheral vascular disease;\r\n\r\n          -  malignancy or history of malignancy within the past 5 years (except basal cell\r\n             carcinoma);\r\n\r\n          -  renal disease and/or impaired renal function as defined by subjects with a creatinine\r\n             clearance of 60 ml/min/24hrs;\r\n\r\n          -  diseases of the gastrointestinal system including active liver disease or current\r\n             active hepatitis;\r\n\r\n          -  subjects with AST and/or ALT >2 times the upper limit of the normal range and/or an\r\n             increased serum bilirubin >2 times the upper limit of normal at screening;\r\n\r\n          -  pulmonary disorders\r\n\r\n          -  endocrinological disorders including thyroid disorders;\r\n\r\n          -  gross neurological disorders including subjects with seizure disorders and subjects\r\n             with progressive or degenerative neurological disorders (e.g., multiple sclerosis)\r\n      ","sponsor":"University of Virginia","sponsor_type":"Other","conditions":"Amphetamine Dependence","interventions":[{"intervention_type":"Drug","name":"Drug: Mirtazapine","description":"15 mg Mirtazapine is administered followed 2 hours later by 20 mg of methamphetamine / placebo (administered at each testing visit)"},{"intervention_type":"Other","name":"Other: Placebo","description":"Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"extent to which mirtazapine reduces methamphetamine induced mood elevation, reward, and interest","time_frame":"At each study visit"}]}
{"nct_id":"NCT00553085","start_date":"2007-09-30","enrollment":141,"brief_title":"Anxiety Disorders in Children - Association With Neurodevelopmental Delay/Disorder","official_title":"Anxiety Disorders in Children - Association With Neurodevelopmental Delay/Disorder and Temperament/Personality. A Clinical Case-control Study","primary_completion_date":"2009-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2014-03-31","last_update":"2014-06-20","description":"The main objective of the study is to examine the relationship between anxiety disorders and neurodevelopmental disorder/delay in children aged 7- 13 years.","other_id":"1.2006.2943","observational_model":"Case-Control","time_perspective":"Cross-Sectional","sampling_method":"Probability Sample","gender":"All","minimum_age":7,"maximum_age":13,"population":"Consecutive patient sampling","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Clinical diagnosis of anxiety disorder or ADHD or no diagnosis\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Clinical diagnosis of PDD\r\n\r\n          -  mental retardation\r\n\r\n          -  children whose both parents do not speak Norwegian\r\n      ","sponsor":"Regionsenter for barn og unges psykiske helse","sponsor_type":"Other","conditions":"Anxiety Disorders","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Diagnosis of anxiety disorder","time_frame":"5 years"},{"outcome_type":"secondary","measure":"Children's global assessment scale (CGAS)","time_frame":"5 years","description":"The CGAS represents an assessment of the child's overall severity of disturbance with scores ranging from 1 (lowest functioning) to 100 (excellent functioning)"}]}
{"nct_id":"NCT01498939","start_date":"2007-08-31","phase":"Phase 1","enrollment":20,"brief_title":"Pharmacokinetics of Insulin Detemir in Healthy Chinese Male Subjects","official_title":"A Single Centre, Randomised, Double-blind, Three-period Cross-over Trial to Investigate the 24-hour Pharmacokinetics After Single Dose of Insulin Detemir in Healthy Chinese Male Subjects","primary_completion_date":"2007-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-09-30","last_update":"2016-10-28","description":"This trial is conducted in Asia. The aim of this trial is to investigate the pharmacokinetics after a single dose of insulin detemir in healthy Chinese male subjects.","other_id":"NN304-1889","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Body mass index (BMI) between 18 and 25 kg/m^2 (both inclusive)\r\n\r\n          -  Fasting plasma glucose maximum 6 mmol/L\r\n\r\n          -  Non-smoker\r\n\r\n          -  Considered generally healthy upon completion of medical history, physical examination\r\n             and laboratory assessments, as judged by the Investigator\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Known or suspected allergy to trial product(s) or related products\r\n\r\n          -  Previous participation in this trial. Participation is defined as randomisation\r\n\r\n          -  Receipt of any investigational drug within the last three months prior to this trial\r\n\r\n          -  History of alcohol or drug abuse\r\n      ","sponsor":"Novo Nordisk A/S","sponsor_type":"Industry","conditions":"Diabetes|Healthy","interventions":[{"intervention_type":"Drug","name":"Drug: insulin detemir","description":"Each subject will be randomly allocated to an insulin detemir dosing sequence. Three doses of insulin detemir (0.2, 0.4 or 0.8 U/kg) will be administered on three inconsecutive days with a wash-out period between each dosing. Injected subcutaneously (s.c., under the skin)"}],"outcomes":[{"outcome_type":"secondary","measure":"Insulin detemir clearance"},{"outcome_type":"secondary","measure":"Adverse events"},{"outcome_type":"secondary","measure":"Area under the insulin detemir concentration curve"},{"outcome_type":"secondary","measure":"Maximum serum insulin detemir concentration"},{"outcome_type":"secondary","measure":"Time to maximum serum insulin detemir concentration"},{"outcome_type":"secondary","measure":"Mean residence time (MRT)"},{"outcome_type":"primary","measure":"Area under the insulin detemir concentration curve","time_frame":"from time zero to 24 hour"},{"outcome_type":"secondary","measure":"Terminal half-life"}]}
{"nct_id":"NCT00805909","start_date":"2007-08-31","phase":"Phase 1/Phase 2","enrollment":12,"brief_title":"NI-0401 in Patients With Acute Renal Allograft Rejection","official_title":"A Phase IIa, Open-Label, Dose-Titration, Multicenter Study to Assess the Safety and Preliminary Efficacy of NI-0401 in Patients With Acute Cellular Renal Allograft Rejection","primary_completion_date":"2009-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-01-31","last_update":"2009-06-09","description":"The purpose of the study is to determine the safety and tolerability of NI-0401 and whether NI-0401 can reverse BpACR.","other_id":"NI-0401-02","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Main inclusion Criteria:\r\n\r\n          -  evidence of cellular rejection in a renal biopsy according to Bannff 97 criteria\r\n\r\n          -  rise in Serum Creatinine concentration by >20% compared to baseline value\r\n\r\n        Main Exclusion Criteria:\r\n\r\n          -  previous therapy with anti-CD3 mAB(OKT3) or anti-lymphocytes polyclonal antibodies\r\n             (ATG, Atgam)\r\n\r\n          -  patients with cardiac insufficiency or fluid overload\r\n\r\n          -  severe HLA sensitization (>50% panel reactive antibodies prior transplantation)\r\n\r\n          -  defined concomitant disease\r\n      ","sponsor":"NovImmune SA","sponsor_type":"Industry","conditions":"Acute Renal Transplant Rejection","interventions":[{"intervention_type":"Drug","name":"Drug: NI-0401","description":"5 daily infusions with escalating doses of NI-0401"}],"outcomes":[{"outcome_type":"primary","measure":"Nature,frequency,intensity,causality and seriousness of adverse events","time_frame":"Studay day 1 to week 6"}]}
{"nct_id":"NCT00447863","start_date":"2007-08-31","phase":"Phase 1","enrollment":0,"brief_title":"Study Evaluating the Bioequivalence of Levonorgestrel/Ethinyl Estradiol Combinations in Cycling Women","official_title":"An Open-Label, Single-Dose, Randomized, 2-Period, Crossover, Bioequivalence Study to Compare Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg in 2 Dosage Forms With Different Dissolution Characteristics in Healthy, Cycling Women","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2007-08-31","last_update":"2021-08-20","description":"Levonorgestrel/ethinyl estradiol (LNG/EE) is an investigational drug that is being developed as an oral contraceptive (birth control pill). The purpose of this trial is to compare different preparations of LNG/EE by assessing the way they are absorbed into the blood.","other_id":"0858A2-109","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":35,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Women aged 18 to 35 years.\r\n\r\n          -  Healthy as determined by the investigator on the basis of medical history and\r\n             screening evaluations.\r\n\r\n          -  Must have a history of normal menstrual cycles (24 to 34 days) for the 3-month period\r\n             preceding entry into the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any surgical or medical condition that may interfere with the absorption,\r\n             distribution, metabolism, or excretion of the test article.\r\n\r\n          -  Presence, history, or family history of thrombophlebitis, thrombosis, or\r\n             thromboembolitic disorders, deep vein thrombosis, pulmonary embolism, or known\r\n             coagulopathy.\r\n\r\n          -  Bethesda system report of low-grade squamous intraepithelial lesion or greater for a\r\n             cervical cytologic smear obtained within the last 3 months.\r\n      ","sponsor":"Wyeth is now a wholly owned subsidiary of Pfizer","sponsor_type":"Industry","conditions":"Contraception","interventions":[{"intervention_type":"Drug","name":"Drug: Levonorgestrel/Ethinyl Estradiol"}],"outcomes":[{"outcome_type":"primary","measure":"To assess the bioequivalence of 2 batches of LNG/EE tablets with different dissolution characteristics"},{"outcome_type":"secondary","measure":"To obtain additional safety and tolerability data concerning LNG/EE in healthy, cycling women"}]}
{"nct_id":"NCT00528853","start_date":"2007-08-31","enrollment":10,"brief_title":"Correlation of Lung Biopsy, BAL, and High Resolution CT Scan in Lung Transplantation","official_title":"Correlation of Lung Biopsy, BAL, and High Resolution CT Scan in Lung Transplantation. Can We Help Diagnose Acute Rejection and Better Predict Bronchiolitis Obliterans?","primary_completion_date":"2009-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2009-12-31","last_update":"2016-08-19","description":"A major source of graft failure and dysfunction in lung transplantation is known to be bronchiolitis obliterans (BO)and its clinical correlate called bronchiolitis obliterans syndrome(BOS). In fact, BOS is the leading cause of death in lung recipients beyond one year post transplant. Currently, our ability to assess lung injury after transplant is less than ideal. The purpose of this study is to use new computerized tomography(CT) technology, specifically , 64 bit acquisition, to detect and predict the onset of lung injuries, with the hope of finding better therapies that currently exist.","other_id":"15660A","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":65,"population":"Lung transplant patients meeting inclusion criteria will be recruited from the lung\r\n        transplant clinic.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Lung transplant patients who are at least 18 years of age.\r\n\r\n          -  All patients must be able to give written informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Lung transplant patients who are unable to undergo a CT Scan.\r\n\r\n          -  Lung transplant patients who are unable to give informed consent.\r\n      ","sponsor":"University of Chicago","sponsor_type":"Other","conditions":"Bronchiolitis Obliterans Syndrome","interventions":{},"outcomes":{}}
{"nct_id":"NCT00529152","start_date":"2007-08-31","phase":"Phase 3","enrollment":100,"brief_title":"Safety and Efficacy of Ferriprox (Deferiprone) Oral Solution in Iron Overloaded Pediatric Patients","official_title":"A 24-Week, Open Label, Uncontrolled Study of the Safety and Efficacy of Ferriprox (Deferiprone) Oral Solution in Iron Overloaded Pediatric Patients With Transfusion-Dependent Anemia","primary_completion_date":"2008-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-07-31","last_update":"2009-09-02","description":"- The primary objective is to assess the safety of Ferriprox oral solution for the treatment of iron overload in pediatric patients with transfusion-dependent anemia. - The secondary objective is to assess the efficacy of Ferriprox oral solution in reducing iron overload in pediatric patients with transfusion-dependent anemia.","other_id":"LA30-0307","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","maximum_age":10,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients who are  10 years of age.\r\n\r\n          -  Patients who have a confirmed diagnosis of transfusion-dependent anemia, other than\r\n             Blackfan-Diamond anemia, and have chronic iron overload requiring chelation therapy.\r\n\r\n          -  Patients who are in a chronic transfusion program, and who have received at least\r\n             eight (8) red blood cell transfusions per year for a minimum of one year.\r\n\r\n          -  Patients who are iron overloaded as assessed by serum ferritin concentration greater\r\n             than 1000 g/L.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who have a diagnosis of Blackfan-Diamond anemia.\r\n\r\n          -  Patients who have experienced neutropenia/agranulocytosis (absolute neutrophil count\r\n             (ANC) < 1.5 x 109/L) or thrombocytopenia (platelet count < 50.0 x 109/L).\r\n\r\n          -  Patients who have had previous treatment with Ferriprox and presented serious adverse\r\n             reaction or intolerance requiring withdrawal of Ferriprox.\r\n\r\n          -  Patients with evidence of abnormal liver function (ALT level > 3 times the upper limit\r\n             of normal; entry may be delayed until values return to normal).\r\n\r\n          -  Patients with evidence of renal failure, characterized by serum creatinine level > 2\r\n             times the upper limit of normal; entry may be delayed until values return to normal.\r\n      ","sponsor":"ApoPharma","sponsor_type":"Industry","conditions":"Iron Overload","interventions":[{"intervention_type":"Drug","name":"Drug: Deferiprone","description":"Ferriprox (deferiprone) oral solution will be given orally at a total daily dose of 75 mg/kg body weight or 100 mg/kg body weight, divided into 3 doses, for 24 weeks."}],"outcomes":[{"outcome_type":"primary","measure":"Occurrence of Adverse Events","time_frame":"24 Weeks","description":"Number of Adverse Events over 24 weeks"},{"outcome_type":"secondary","measure":"Change in Serum Ferritin Concentration From Baseline.","time_frame":"Baseline and 24 weeks","description":"The change in serum ferritin concentration from baseline to week 24 was measured and analyzed for all participants in the study"}]}
{"nct_id":"NCT00513409","start_date":"2007-08-22","phase":"Phase 2","enrollment":163,"brief_title":"Assess Reacto- and Immunogenicity of Pneumococcal Conjugate Vaccine When Given as Booster or a 2 Dose Catch up Schedule","official_title":"Phase II, Observer-blind Follow-up Study to Assess reacto-and Immunogenicity of GSK Biologicals' Pneumococcal Conjugate Vaccine (GSK1024850A), When Given as Booster in Primed Children or as 2-dose Catch-up in Unprimed Children.","primary_completion_date":"2008-02-20","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-08-28","last_update":"2018-12-19","description":"This is a booster study in 2 groups of healthy children less than 3 years old to measure the reactogenicity, safety and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine, when given as a booster or as a two-dose catch-up vaccination. This protocol posting deals with objectives and outcome measures of the booster phase. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00338351).","other_id":"110031","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":1.5,"maximum_age":1.75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female between, and including, 18-21 months of age at the time of vaccination.\r\n\r\n          -  Subjects who previously participated in the primary study and received 3 doses of\r\n             study or control vaccines during the primary study.\r\n\r\n          -  Subjects for whom the investigator believes that their parents/guardians can and will\r\n             comply with the requirements of the protocol.\r\n\r\n          -  Written informed consent obtained from the parent or guardian of the subject.\r\n\r\n          -  Free of obvious health problems as established by medical history and clinical\r\n             examination before entering into the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Use of any investigational or non-registered drug or vaccine other than the study\r\n             vaccine(s) within 30 days preceding the booster doses of study vaccines, or planned\r\n             use during the study period (active phase and extended safety follow-up).\r\n\r\n          -  Planned administration/ administration of a vaccine not foreseen by the study protocol\r\n             during the period starting one month (30 days) before the booster doses of vaccine(s)\r\n             and during the active phase of the study (up to the follow-up visit (Visit 3)).\r\n\r\n          -  History of allergic disease or reactions likely to be exacerbated by any component of\r\n             the vaccines.\r\n\r\n          -  History of seizures (subjects who have had a single, uncomplicated febrile convulsion\r\n             in the past can be included) or progressive neurological disease.\r\n\r\n          -  Acute disease at the time of enrolment.\r\n\r\n          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other\r\n             immune-modifying drugs within 6 months prior to the booster doses of study vaccines.\r\n\r\n          -  Any confirmed or suspected immunosuppressive or immunodeficient condition based on\r\n             medical history and physical examination.\r\n\r\n          -  A family history of congenital or hereditary immunodeficiency.\r\n\r\n          -  Major congenital defects or serious chronic illness.\r\n\r\n          -  Administration of immunoglobulins and/or any blood products within the last 3 months\r\n             prior to booster or follow-up vaccination or planned administration during the active\r\n             phase of the study.\r\n      ","sponsor":"GlaxoSmithKline","sponsor_type":"Industry","conditions":"Infections, Streptococcal","interventions":[{"intervention_type":"Biological","name":"Biological: Synflorix","description":"Intramuscular injection, 1 or 2 doses"},{"intervention_type":"Biological","name":"Biological: Infanrix Hexa","description":"1 Intramuscular injection"},{"intervention_type":"Biological","name":"Biological: Havrix","description":"1 Intramuscular injection"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited)","time_frame":"Within 4 days after the administration of any study vaccine dose","description":"Grade 3 symptoms are symptoms which prevent normal, everyday activities (e.g. in a young child such symptom would prevent attendance at school/ kindergarten/ a day-care center and would cause the parents/guardians to seek medical advice)."},{"outcome_type":"secondary","measure":"Number of Subjects Reporting Solicited Local Symptoms","time_frame":"Within 4 days after the administration of any study vaccine dose","description":"Solicited local symptoms assessed include pain, redness and swelling."},{"outcome_type":"secondary","measure":"Number of Subjects Reporting Solicited General Symptoms","time_frame":"Within 4 days after the administration of any study vaccine dose","description":"Solicited general symptoms assessed include drowsiness, fever, irritability and loss of appetite.\r\nFever was defined as rectal temperature ≥ 38 degrees Celsius."},{"outcome_type":"secondary","measure":"Number of Subjects Reporting Unsolicited Adverse Events","time_frame":"Within 31 days after the administration of any study vaccine dose","description":"An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product."},{"outcome_type":"secondary","measure":"Number of Subjects Reporting Serious Adverse Events During the Active Phase of the Study","time_frame":"Throughout the active phase of the study ( from the beginning of the booster phase up to 1 month after the second booster dose)","description":"A serious adverse event (SAE) is any untoward medical occurrence that:\r\nresults in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."},{"outcome_type":"secondary","measure":"Number of Subjects Reporting Serious Adverse Events Throughout the Entire Study Period","time_frame":"Throughout the entire study period (from the beginning of the booster phase up to the end of the 6-month extended safety follow-up)","description":"An SAE is any untoward medical occurrence that:\r\nresults in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."},{"outcome_type":"secondary","measure":"Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value","time_frame":"Before (pre) and one month after (post) the administration of Dose 2","description":"Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (μg/mL).\r\nThe vaccine pneumococcal serotypes assessed include 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F."},{"outcome_type":"secondary","measure":"Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value","time_frame":"Before (pre) and one month after (post) the administration of Dose 2","description":"Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was ≥ 8\r\nThe vaccine pneumococcal serotypes assessed include 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F."},{"outcome_type":"secondary","measure":"Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value","time_frame":"Before (pre) and one month after (post) the administration of Dose 2","description":"Anti-protein D antibody cut-off value assessed was ≥ 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL)."},{"outcome_type":"secondary","measure":"Anti-hepatitis A Virus Antibodies Concentration","time_frame":"Before (pre) and one month after (post) the administration of Dose 2","description":"Concentration of anti-hepatitis A antibodies given as geometric mean concentration (GMC) in milli-international units per milliliter (mIU/mL)."},{"outcome_type":"secondary","measure":"Number of Subjects With Anti-hepatitis A Antibody Concentrations Above the Cut-off Value","time_frame":"Before (pre) and one month after (post) the administration of Dose 2","description":"Anti-hepatitis A antibodies cut-off value assessed was ≥ 15 mIU/mL."}]}
{"nct_id":"NCT00593554","start_date":"2007-08-07","phase":"Phase 2","enrollment":9,"brief_title":"Phase 2 Haplotype Mismatched HSCT in Patients With Hematological Malignancies","official_title":"A Phase II Trial of Haplotype Mismatched Hematopoietic Stem Cell Transplantation Using Highly Purified CD34 Cells in Patients With Hematological Malignancies","primary_completion_date":"2016-08-27","study_type":"Interventional","rec_status":"Terminated","completion_date":"2017-07-28","last_update":"2018-04-10","description":"The purpose of this study is to determine if haplotype-mismatched HSCT is associated with an improvement in treatment-related mortality (TRM) rate at 6 months.","other_id":"0704-19 IUCRO-0184","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients must have histologically documented AML, ALL, MDS, CML, Acute myeloid\r\n             leukemia (AML) with one or more of the following criteria\r\n\r\n               -  CR 1 with poor risk features\r\n\r\n               -  CR 2, or higher order CR\r\n\r\n          -  Acute lymphoblastic leukemia (ALL) with one of the following criteria\r\n\r\n               -  CR 1 with poor risk features\r\n\r\n               -  CR 2, or higher order CR\r\n\r\n          -  Myelodysplasia, RAEB I\r\n\r\n          -  Donor has been identified\r\n\r\n          -  Age  65 years.\r\n\r\n          -  Performance Status 0-1.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients relapsing <6 months after autologous SCT are not eligible.\r\n\r\n          -  Patients with active infections requiring oral or intravenous antibiotics are not\r\n             eligible for enrollment until resolution of infection.\r\n\r\n          -  Non-pregnant and non-nursing\r\n      ","sponsor":"Sherif S. Farag","sponsor_type":"Other","conditions":"Acute Myeloid Leukemia|Acute Lymphoblastic Leukemia|Myelodysplasia|Chronic Myeloid Leukemia","interventions":[{"intervention_type":"Biological","name":"Biological: Rabbit ATG","description":"2.5 mg/kg/d on Day -5 to -2"},{"intervention_type":"Radiation","name":"Radiation: Total Body Irradiation","description":"8 Gy on Day -9"},{"intervention_type":"Drug","name":"Drug: Thiotepa","description":"5 mg/kg/d on Day -8 to -7"},{"intervention_type":"Drug","name":"Drug: Fludarabine","description":"40 mg/m2/d on Day -6 to -3"},{"intervention_type":"Drug","name":"Drug: Palifermin","description":"60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2"}],"outcomes":[{"outcome_type":"primary","measure":"Treatment-related Mortality (TRM) Rate at 6 Months After Transplantation","time_frame":"thru 6 months after transplant","description":"To determine if haplotype-mismatched HSCT is associated with a ≤40% treatment-related mortality (TRM) rate at 6 months after transplantation; a TRM ≥60% being considered unacceptable. The percent of patients with the exact 95% confidence interval who had treatment-related mortality within 6 months of their transplant is presented."},{"outcome_type":"secondary","measure":"Regimen-related Toxicity","time_frame":"Up to 1 year","description":"The number of unique patients who had adverse events that were possibly/probably/definitely related to treatment/regimen."},{"outcome_type":"secondary","measure":"Time to Neutrophil Engraftment","time_frame":"Transplant (Day 0) up to 1 year","description":"Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophil is defined as the time from transplant until absolute neutrophil count (ANC) > 500 uL for 3 consecutive days. The median and 95% confidence intervals will be provided."},{"outcome_type":"secondary","measure":"Time to Platelet Engraftment","time_frame":"Transplant (Day 0) up to 1 year","description":"Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive days after transplantation during which the platelet count is at least 20 x109/l without transfusion support. Only patients who achieved engraftment of platelets will be included in the analysis. The median and 95% confidence intervals will be provided."},{"outcome_type":"secondary","measure":"Acute Graft vs. Host Disease (GvHD)","time_frame":"Up to 1 year","description":"Number of unique patients who had acute Graft vs. Host Disease (GvHD) diagnosed while on the study."},{"outcome_type":"secondary","measure":"Chronic Graft vs. Host Disease (GvHD)","time_frame":"Up to 1 year","description":"Number of unique patients who had chronic Graft vs. Host Disease (GvHD) diagnosed while on the study."},{"outcome_type":"secondary","measure":"Frequency of Infection","time_frame":"Day 0 through 1 year post transplantation","description":"Number of unique patients with bacterial and/or viral infections reported."}]}
{"nct_id":"NCT00493519","start_date":"2007-07-31","phase":"N/A","enrollment":75,"brief_title":"Cephalic Phase in Anorexia Nervosa,Bulimia Nervosa and Obese Binge Eaters","official_title":"Cephalic Phase in Anorexia Nervosa,Bulimia Nervosa and Obese Binge Eaters","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2007-12-31","last_update":"2007-07-06","description":"The objective of this trial is to examine the cephalic phase insulin response (CPIR) and pancreatic polypeptide (PP) release as indicators of the cephalic phase occurrence and magnitude to palatable food stimulus in anorectic and bulimic subgroups as compared to healthy controls","other_id":"TASMC-07-NV-219-CTIL","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        75 patients will be divided into the following 4 subgroups;\r\n\r\n          1. . 15 patients with anorexia nervosa.\r\n\r\n          2. . 15 patients with bulimia nervosa (purging type).\r\n\r\n          3. . 15 patients with binge eating disorder and obesity.\r\n\r\n          4. . 15 obese patients without eating disorder\r\n\r\n          5. . 15 Non-eating disordered normal weight patients.\r\n\r\n        Non diabetic and non-pregnant patients above 18 years of age without gastrointestinal\r\n        diseases and without medications which can affect gastrointestinal motility and appetite.\r\n      ","sponsor":"Tel-Aviv Sourasky Medical Center","sponsor_type":"Other","conditions":"Anorexia Nervosa|Bulimia Nervosa","interventions":[{"intervention_type":"Procedure","name":"Procedure: chocolate cake"}],"outcomes":[{"outcome_type":"primary","measure":"VAS, EDI, Blood test for glucose, insulin, PP, shame feed procedure","time_frame":"1 year"}]}
{"nct_id":"NCT00498745","start_date":"2007-07-31","phase":"Phase 1","enrollment":36,"brief_title":"Study Comparing 2 New Formulations of HKI-272 in Healthy Adult Subjects","official_title":"A Single Dose Bioavailability Study of 2 New Formulations of HKI-272 (240 mg) Compared With a Reference Capsule and an Oral Solution in Healthy Adult Subjects","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-09-30","last_update":"2012-05-14","description":"To evaluate the comparative bioavailability of 2 new tablet formulations of HKI-272 with a reference capsule and an oral solution in healthy subjects.","other_id":"3144A1-1109","allocation":"Randomized","intervention_model":"Crossover Assignment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":50,"population":"","criteria":"\n        Criteria:\r\n\r\n          -  Healthy male and female subjects aged 18 to 50 years.\r\n\r\n          -  Women of nonchildbearing potential (WONCBP)\r\n      ","sponsor":"Puma Biotechnology, Inc.","sponsor_type":"Industry","conditions":"Healthy","interventions":[{"intervention_type":"Drug","name":"Drug: neratinib","description":"HKI-272"}],"outcomes":[{"outcome_type":"primary","measure":"The data from this study along with in vitro data will be used to explore in vitro/in vivo correlation for HKI-272 to support formulation development."}]}
{"nct_id":"NCT00941889","start_date":"2007-07-31","phase":"N/A","enrollment":32,"brief_title":"The Effect of HPV Vaccination on Recurrence Rates in HIV Patients With Condylomata","official_title":"The Effect of Human Papillomavirus Vaccination on Recurrence Rates in HIV Positive Patients Treated for Anal Condylomata","primary_completion_date":"2011-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-07-31","last_update":"2016-07-25","description":"The primary objective of this pilot study is to evaluate the effect of the HPV vaccine Gardasil on anal condylomata recurrence and persistence rates in HIV positive patients.","other_id":"HRPO 07-0648","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18 years of age;\r\n\r\n          -  HIV positive status;\r\n\r\n          -  CD4 > 200 and viral RNA < 400 on anti-retroviral therapy (HAART) or CD4 > 350 if not\r\n             on HARRT;\r\n\r\n          -  the presence of anal warts that require surgical excision/ablation.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  CD4 < 200 and/or viral RNA > 400 on HAART or CD4 < 350 and not on HAART ;\r\n\r\n          -  low burden of anal warts that would not require surgical excision/ablation;\r\n\r\n          -  previous vaccinations against HPV or allergic reactions to any vaccine component;\r\n\r\n          -  patients who are currently pregnant;\r\n\r\n          -  patients with a previous diagnosis of anal cancer;\r\n\r\n          -  patients who are incarcerated;\r\n\r\n          -  patients who have taken immunomodulators (i.e. interferon, interleukin,\r\n             corticosteroids, etc.) within the last 90 days;\r\n\r\n          -  patients who have had an opportunistic infection in the last 90 days or who have\r\n             another intercurrent illness that precludes their safe enrollment in this study;\r\n\r\n          -  patients who, in the judgment of the investigators, are unlikely to adhere to the\r\n             protocol, either because of a substance abuse or psychiatric diagnosis, or other\r\n             factors that would affect compliance;\r\n\r\n          -  failure to strictly comply with the vaccination schedule.\r\n      ","sponsor":"Washington University School of Medicine","sponsor_type":"Other","conditions":"HIV Positive|Anal Condylomata|Anal Warts|HIV Infections","interventions":[{"intervention_type":"Drug","name":"Drug: Saline","description":"0.5 ml"},{"intervention_type":"Drug","name":"Drug: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine","description":"0.5mL intramuscular injection of Gardasil (quadrivalent HPV vaccine) in their upper extremity initially and again at two months and six months after enrollment."}],"outcomes":[{"outcome_type":"primary","measure":"The Primary Endpoint of This Study is Persistence and Recurrence of Anal Warts as Compared Between the Experimental and Control Groups.","time_frame":"Follow up evaluation after treatment at 1, 3, 6, 9. 12, 15, 18 months after initial treatment","description":"Persistence of anal warts will be measured by the presence of any lesions at one month follow-up after surgery. Recurrence of anal warts will be measured by the development of new lesions after one month of follow-up."}]}
{"nct_id":"NCT00786331","start_date":"2007-07-31","phase":"Phase 2","enrollment":230,"brief_title":"Pemetrexed +/- Carboplatin as Second Line Treatment in NSCLC","official_title":"Randomized Phase II Study of Pemetrexed Versus Pemetrexed and Carboplatin as Second Line Chemotherapy in Advanced Non-small-cell Lung Cancer (NSCLC).","primary_completion_date":"2009-07-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2009-12-31","last_update":"2009-08-03","description":"The aim of this study is to compare time to progression between the combination pemetrexed-carboplatin and pemetrexed alone in previously treated patients with locally advanced or metastatic NSCLC.","other_id":"GOIRC 02/2006","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  written informed consent\r\n\r\n          -  Histologically or cytologically confirmed non-small-cell lung cancer\r\n\r\n          -  Unresectable stage IIIB, stage IV and unresectable local relapse or metastatic\r\n             disease, with evidence of disease progression after first line chemotherapy which\r\n             should have included a platinum agent.\r\n\r\n          -  ECOG performance status lower than or equal to 2\r\n\r\n          -  Adequate hematological, hepatic and renal functions\r\n\r\n          -  Life expectancy greater than or equal to 12 weeks\r\n\r\n          -  Prior treatment with only 1 chemotherapy regimen for the treatment of advanced disease\r\n             which should have included a platinum agent\r\n\r\n          -  At baseline, presence of at least one measurable target lesion as per RECIST criteria\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior treatment with pemetrexed.\r\n\r\n          -  Patients who are pregnant or lactating\r\n\r\n          -  Patients with any underlying medical condition that might be aggravated by treatment\r\n             or which cannot be controlled.\r\n\r\n          -  Symptomatic brain metastases\r\n\r\n          -  History of another malignancy within the past five years except basal cell carcinoma\r\n             of the skin or carcinoma in situ of the cervix.\r\n\r\n          -  Concomitant treatment with any other anticancer drug.\r\n      ","sponsor":"Gruppo Oncologico Italiano di Ricerca Clinica","sponsor_type":"Other","conditions":"Advanced Non-Small Cell Lung Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Pemetrexed","description":"Pemetrexed 500 mg/m2 i.v. over approximately 10 minutes on day 1 of a 21 days cycle"},{"intervention_type":"Drug","name":"Drug: Pemetrexed plus carboplatin","description":"Pemetrexed 500 mg/m2 i.v. over approximately 10 minutes on day 1 and Carboplatin AUC 5 i.v. over approximately 30 minutes on day 1 (beginning approximately 30 minutes after the end of the pemetrexed infusion) of a 21 days cycle"}],"outcomes":[{"outcome_type":"primary","measure":"To compare time to progression between the combination pemetrexed-carboplatin and pemetrexed alone in previously treated patients with locally advanced or metastatic NSCLC","time_frame":"36 months"},{"outcome_type":"secondary","measure":"To assess differences in terms of response rate between the combination pemetrexed-carboplatin and pemetrexed alone.","time_frame":"3 months"},{"outcome_type":"secondary","measure":"To assess differences in terms of duration of response between the combination pemetrexed-carboplatin and pemetrexed alone.","time_frame":"36 months"},{"outcome_type":"secondary","measure":"To assess differences in terms of toxicity between the combination pemetrexed-carboplatin and pemetrexed alone.","time_frame":"3 months"},{"outcome_type":"secondary","measure":"To assess differences in terms of survival between the combination pemetrexed-carboplatin and pemetrexed alone.","time_frame":"36 months"}]}
{"nct_id":"NCT00670332","start_date":"2007-07-31","enrollment":773,"brief_title":"Prognostic Assessment of Contrast Echocardiography (PACE Study)","official_title":"Prognostic Assessment of Contrast Echocardiography (PACE Study): An Observational Follow-up Study of Patients With Chest Pain Evaluated With AI-700 Contrast Echocardiography","study_type":"Observational","rec_status":"Terminated","last_update":"2008-05-01","description":"This study will demonstrate whether patients with prognostically-significant myocardial abnormalities detected with AI-700 contrast ECHO have a rate of cardiac death or MI that is higher than that of patients with normal AI-700 contrast ECHO.","other_id":"AI-700-36","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":80,"population":"This observational study will enroll up to 773 patients who participated in either\r\n        AI-700-32 or AI-700-33 and who were evaluated with AI-700 contrast ECHO at rest and at\r\n        pharmacologic-induced stress. Approximately 28 international study centers will\r\n        participate. At the time of AI-700 contrast ECHO (defined as the index date), the patients\r\n        were to have had a recent history of chest pain and were to meet all eligibility criteria.\r\n        Chest pain (angina) was defined as either:\r\n\r\n          -  typical chest pain: 1) substernal chest discomfort with a characteristic quality and\r\n             duration that is 2) provoked by exertion or emotional stress and 3) relieved by rest\r\n             or nitroglycerin, or\r\n\r\n          -  atypical chest pain (angina) that meets 2 of the 3 typical chest pain characteristics.","criteria":"\n        Eligible patients were enrolled in either AI-700-32 or AI-700-33.\r\n      ","sponsor":"Acusphere","sponsor_type":"Industry","conditions":"Coronary Artery Disease","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"The primary outcome variable is the time to first occurrence of the composite outcome (death or confirmed non fatal MI).","time_frame":"The time between AI 700 ECHO and outcomes data collection will be ≥12 months with an expected average follow-up period of 24 months"},{"outcome_type":"secondary","measure":"Certain secondary analyses will include revascularizations and CHF.","time_frame":"The time between AI 700 ECHO and outcomes data collection will be ≥12 months with an expected average follow-up period of 24 months"}]}
{"nct_id":"NCT02170532","start_date":"2007-07-31","phase":"Phase 4","enrollment":10,"brief_title":"Aerosolized Beta-Agonist Isomers in Asthma","official_title":"Aerosolized Beta-Agonist Isomers in Asthma","primary_completion_date":"2009-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-07-31","last_update":"2014-08-13","description":"Dr. MacIntyre and his colleagues are studying inhaled medications in asthma. There are two new medications that have been approved by the United States Food and Drug Administration (FDA): levalbuterol and formoterol. Both of these drugs are similar to standard asthma bronchodilator drugs but offer theoretical advantages in terms of fewer side effects. There are also newer devices to deliver these medications into the lungs: breath actuated nebulizers (BANs) and non-static chambers (Aerochamber-max) that can be used with metered dose inhalers (MDIs or \"puffers\"). The purpose of this study is to deliver these new medications using several different devices and measuring lung function, heart rate, and sensations of breathlessness.","other_id":"Pro00013822","allocation":"Non-Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  stable mild to moderate persistent asthma as defined by the National Asthma Education\r\n             and Prevention Program\r\n\r\n          -  greater than 18 years of age\r\n\r\n          -  requiring bronchodilator therapy either routinely or on a as needed (PRN)basis\r\n\r\n          -  stable with respect to respiratory disease and at least four weeks removed from the\r\n             most recent acute exacerbation of the disease\r\n\r\n          -  patients may or may not be on inhaled corticosteroids\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  no unstable cardiovascular symptoms\r\n\r\n          -  no unstable angina\r\n\r\n          -  must be at least four weeks removed from an acute coronary syndrome\r\n      ","sponsor":"Duke University","sponsor_type":"Other","conditions":"Asthma","interventions":[{"intervention_type":"Drug","name":"Drug: levalbuterol","description":"0.5 ml. levalbuterol"},{"intervention_type":"Drug","name":"Drug: saline","description":"0.5ml saline"},{"intervention_type":"Other","name":"Other: levalbuterol MDI"},{"intervention_type":"Device","name":"Device: breath actuated nebulizer"},{"intervention_type":"Device","name":"Device: aerochamber max"},{"intervention_type":"Drug","name":"Drug: ipratroprium"}],"outcomes":[{"outcome_type":"primary","measure":"Change in Maximum Forced Expiratory Volume at One Second (FEV1)","time_frame":"Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment"},{"outcome_type":"secondary","measure":"Change in 8 Hour Area-under-the-curve FEV1","time_frame":"0 to 8 hours post dose"},{"outcome_type":"secondary","measure":"Change in Heart Rate","time_frame":"Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment"},{"outcome_type":"secondary","measure":"Change in Tremor Assessment Measured by a Scale","time_frame":"Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment","description":"Tremor assessment will be made on outstretched hands (0 = none, 1+ = fine tremor, barely perceptible, 2+ = obvious tremor)."},{"outcome_type":"secondary","measure":"Change in Dyspnea Response as Measured by the University of California, San Diego (UCSD) Dyspnea Scale","time_frame":"Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment"}]}
{"nct_id":"NCT00987922","start_date":"2007-07-31","phase":"Phase 2","enrollment":36,"brief_title":"Mild Hypothermia in Acute Ischemic Stroke","official_title":"Mild Hypothermia in Acute Ischemic Stroke After Thrombolytic Therapy: a Prospective,Open,Randomized,Single-center,Safety and Feasibility Study","primary_completion_date":"2011-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-09-30","last_update":"2011-09-20","description":"Hypothesis: Mild hypothermia using non-invasive temperature management system in a stroke unit is safe and feasible in spontaneously breathing, alteplase-thrombolyzed patients with acute ischemic stroke.","other_id":"FI-HUCH-220424","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Acute ischemic hemispheric stroke treated with Actilyse(tPA)-thrombolysis according to\r\n             Meilahti protocol\r\n\r\n          -  NIHSS 7-20 (after thrombolysis) or a significant paresis of arm or leg (NIHSS 3, no\r\n             movement against gravity) or a significant dysphasia (NIHSS 2-3) despite of the total\r\n             NIHSS score\r\n\r\n          -  Symptom onset within 6 hour\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Platelet count < 75,000/mm3\r\n\r\n          -  Known coagulopathy (INR spontaneously >1.5)\r\n\r\n          -  Hemodynamical unstability\r\n\r\n          -  Recent history of angina pectoris or acute myocardial infarction\r\n\r\n          -  Sepsis within 72 hours\r\n\r\n          -  Pregnancy\r\n\r\n          -  Pre-existing neurological disability with modified Rankin Scale Score>2\r\n\r\n          -  Known allergy or intolerance to buspirone, dexmedetomidine, meperidine\r\n\r\n          -  Intracranial hemorrhage in brain CT scan\r\n\r\n          -  Intracranial mass lesion (i.e., abscess, tumor, or infection)\r\n\r\n          -  Participation in an other therapy trial within last 3 months\r\n\r\n          -  Hypothermia- treatment cannot be initiated within 6 hours of symptom onset\r\n\r\n          -  Protocol violation in thrombolytic therapy\r\n\r\n          -  Any condition where researchers assume that the patient is not suitable (must be\r\n             reasoned)\r\n      ","sponsor":"University of Helsinki","sponsor_type":"Other","conditions":"Brain Ischemia","interventions":[{"intervention_type":"Device","name":"Device: Hypothermia","description":"Hypothermia to core temperature of 35C for 12 hours, rewarming rate 0.2C until the patient reaches 36.8C"}],"outcomes":[{"outcome_type":"primary","measure":"The proportion of patients maintaining temperature below 36.0°C 80% of the 12-hour hypothermia period.","time_frame":"12 hours"},{"outcome_type":"secondary","measure":"The incidence of intracerebral hemorrhage, infections, hemodynamically significant cardiac arrhythmias, severe disturbance of electrolytes and fluid balance, thrombocytopenia, and serious adverse events","time_frame":"14 days"},{"outcome_type":"secondary","measure":"All-cause mortality during acute phase (7 days), 1 month, and 3 month follow-up; and readmission to hospital for any reason within 3-months.","time_frame":"3 months"},{"outcome_type":"secondary","measure":"The proportion of modified Rankin Scale-responders (mRS 0-2), Barthel Index, NIHSS, Glasgow Outcome Scale","time_frame":"3 months"},{"outcome_type":"secondary","measure":"Neuropsychological tests","time_frame":"3 months"},{"outcome_type":"secondary","measure":"Size of infarction in MRI, and grading of the possible hemorrhagic transformation according to SITS scale (MRI includes scout images, DWI, T1, T2, FLAIR, T2*, and MR angiography)","time_frame":"3-7 days"}]}
{"nct_id":"NCT00488969","start_date":"2007-07-31","phase":"Phase 2","enrollment":17,"brief_title":"Effectiveness of Controlled-Release Morphine for Chronic Neuropathic Pain After Spinal Cord Injury","official_title":"Effectiveness of Controlled-Release Morphine for Chronic Neuropathic Pain After Spinal Cord Injury","primary_completion_date":"2013-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-07-31","last_update":"2016-03-22","description":"We would like to learn if a medicine called \"modified-release morphine sulfate\" (Avinza) helps reduce Spinal Cord Injury (SCI)-related pain that has lasted a long time. \"Modified-release\" means that the medicine in the capsules is slowly released to the body, instead of being released all at once. Avinza is approved by the Food and Drug Administration for the treatment of pain, but we do not know how effective Avinza is in reducing SCI-related pain.","other_id":"H133N060027","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age 18 - 65\r\n\r\n          -  Diagnosis of traumatic spinal cord injury\r\n\r\n          -  Neuropathic pain (pain related to the nervous system) rated at least 4 on a 11-point\r\n             numeric rating scale at the time of screening\r\n\r\n          -  Pain classified as at level radicular pain (ALRP), at level central pain (ALCP) or\r\n             below level central pain (BLCP).\r\n\r\n          -  Pain that is present regularly for at least 3 months prior to enrollment, in spite of\r\n             medication or other pain treatment. This pain can be paroxysmal in nature (attacks of\r\n             pain).\r\n\r\n          -  Ability to understand instructions and reliably provide pain assessments\r\n\r\n          -  Willingness to stop current opioid medications, if any\r\n\r\n          -  If a female with childbearing potential, using an approved method of birth control\r\n             (intrauterine device (IUD), barrier protection, a contraceptive implantation system or\r\n             injection (Norplant or Depo-Provera), oral contraceptive pills, or celibacy)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  A known sensitivity to opioids\r\n\r\n          -  A history of substance or alcohol abuse within the past 2 years\r\n\r\n          -  A need for elective surgery involving preoperative or postoperative analgesics or\r\n             anesthetics during the study period\r\n\r\n          -  Other chronic pain that cannot be differentiated from ALCP, ALRP, or BLCP\r\n\r\n          -  A history of active cancer, excluding basal carcinoma of the skin, in the past 3 years\r\n\r\n          -  Serum creatinine levels >= 2.5 mg/dl or hepatic (liver) dysfunction with serum ALT,\r\n             AST, GGT, or total bilirubin >= 3 times the upper limit of normal\r\n\r\n          -  Participation in any drug study in the last three months\r\n\r\n          -  Currently pregnant or breastfeeding\r\n      ","sponsor":"Icahn School of Medicine at Mount Sinai","sponsor_type":"Other","conditions":"Neuropathic Pain|Spinal Cord Injury","interventions":[{"intervention_type":"Drug","name":"Drug: Modified-release morphine","description":"During the first three weeks of each treatment (drug or placebo), the dose will be escalated toward a maximally tolerated dose or a dose sufficient to eliminate pain (up to a ceiling dose of 120 mg), whichever is reached first. During the entire fourth and fifth week of each period, subjects will receive their maximally tolerated dose of study medication. During the sixth and seventh weeks, they will undergo a seven-day dose tapering and a seven-day complete washout of the study drug."},{"intervention_type":"Drug","name":"Drug: Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"Pain severity","time_frame":"Average of daily ratings over 14 days","description":"Pain severity rated using a 0-10 Numeric Rating Scale (NRS)"},{"outcome_type":"secondary","measure":"Short McGill Pain Questionnaire (modified) (SF-McGill)","time_frame":"up to 14 weeks"},{"outcome_type":"secondary","measure":"Opioids cognitive effects scale","time_frame":"up to 14 weeks"},{"outcome_type":"secondary","measure":"Patient Generated Index for activity (PGI)","time_frame":"up to 14 weeks"},{"outcome_type":"secondary","measure":"Daily number of attacks of paroxysmal pain","time_frame":"up to 14 weeks"},{"outcome_type":"secondary","measure":"Quantitative sensory testing","time_frame":"up to 14 weeks","description":"Allodynia, hyperalgesia, and temporal summation (determined using quantitative sensory testing)"},{"outcome_type":"secondary","measure":"Subject global impression of change","time_frame":"up to 14 weeks"},{"outcome_type":"secondary","measure":"Short-Form 36 (SF-36)","time_frame":"up to 14 weeks"},{"outcome_type":"secondary","measure":"Positive And Negative Affect Schedule (PANAS)","time_frame":"up to 14 weeks"},{"outcome_type":"secondary","measure":"Brief Patient Health Questionnaire (PHQ-9)","time_frame":"up to 14 weeks"},{"outcome_type":"secondary","measure":"Multidimensional Pain Inventory Life Interference subscale (MPI-LIS)","time_frame":"up to 14 weeks"}]}
{"nct_id":"NCT00507416","start_date":"2007-06-30","phase":"Phase 3","enrollment":502,"brief_title":"Velcade,Thalidomide, and Dexamethasone Versus Velcade and Dexamethasone Versus Velcade, Melphalan, and Prednisone","official_title":"Randomized Phase 3b Study of Three Treatment Regimens in Subjects With Previously Untreated Multiple Myeloma Who Are Not Considered Candidates for High-Dose Chemotherapy and Autologous Stem Cell Transplantation: VELCADE, Thalidomide, and Dexamethasone Versus VELCADE and Dexamethasone Versus VELCADE, Melphalan, and Prednisone","primary_completion_date":"2013-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-03-31","last_update":"2014-05-01","description":"This is a randomized, open label, multicenter clinical trial to compare the efficacy and safety of Velcade (bortezomib) and dexamethasone versus Velcade, thalidomide, and dexamethasone versus Velcade, melphalan, and prednisone in patients with previously untreated multiple myeloma not considered candidates for high-dose chemotherapy and autologous stem cell transplantation.","other_id":"C05009","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female 18 years of age or older\r\n\r\n          -  Not a candidate for high-dose chemotherapy and stem cell transplantation (HDT/SCT) due\r\n             to age, presence of important comorbid condition(s) likely to have a negative impact\r\n             on tolerability of HDT-SCT, or subject preference.\r\n\r\n          -  A Karnofsky Performance Status score of 50%\r\n\r\n          -  Symptomatic multiple myeloma or asymptomatic multiple myeloma with related organ or\r\n             tissue damage.\r\n\r\n          -  Asymptomatic multiple myeloma-related organ or tissue damage can include presence of\r\n             an asymptomatic lytic bone lesion or plasmacytoma, the presence of anemia (hemoglobin\r\n             <10 g/dL), renal function impairment (serum creatinine > upper limit of normal [ULN])\r\n             or hypercalcemia (serum calcium >ULN).\r\n\r\n          -  Must have measurable disease requiring systemic therapy. Measurable disease is defined\r\n             by at least 1 of the following criteria:\r\n\r\n               -  Quantifiable serum M-protein value (>1 g/dL of immunoglobulin (Ig)G or IgM\r\n                  M-protein, >0.5g/dL of IgA M-protein, >0.5 g/dL of IgD M-protein)\r\n\r\n               -  Urine light-chain excretion 200 mg/24 hours\r\n\r\n          -  Voluntary written informed consent must be given before performance of any study\r\n             related procedure not part of normal medical care, with the understanding that consent\r\n             may be withdrawn by the participant at any time without prejudice to future medical\r\n             care.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Diagnosis of smoldering multiple myeloma or monoclonal gammopathy of undetermined\r\n             significance (MGUS). Smoldering multiple myeloma is defined as asymptomatic multiple\r\n             myeloma with absence of lytic bone lesions. MGUS is defined by presence of serum\r\n             monoclonal protein <3 g/dL; absence of lytic bone lesions, anemia, hypercalcemia, and\r\n             renal insufficiency related to the monoclonal protein; and (if determined) proportion\r\n             of plasma cells in the bone marrow of 10% or less.\r\n\r\n          -  Diagnosis of Waldenstrm's disease or other conditions in which immunoglobulin M (IgM)\r\n             M-protein is present in the absence of a clonal plasma cell infiltration or lytic bone\r\n             lesions.\r\n\r\n          -  Previously or currently treated with any systemic therapy for multiple myeloma. Prior\r\n             treatment of hypercalcemia or spinal cord compression with corticosteroids or\r\n             radiation therapy, respectively, does not disqualify the subject (the dose of\r\n             corticosteroids should not exceed the equivalent of 160 mg of dexamethasone in 2-week\r\n             period).\r\n\r\n          -  Radiation therapy within 2 weeks before randomization. Enrollment of patients who\r\n             require concurrent radiotherapy (which must be localized in its field size) should be\r\n             deferred until the radiotherapy is completed and 2 weeks have elapsed since the last\r\n             date of therapy.\r\n\r\n          -  Major surgery within 30 days before randomization (Kyphoplasty is not considered major\r\n             surgery)\r\n\r\n          -  History of allergy to any of the study medications, their analogues, or excipients in\r\n             the various formulations\r\n\r\n          -  Grade 2 peripheral neuropathy on clinical examination within 21 days before\r\n             enrollment.\r\n\r\n          -  Any of the following clinical laboratory values within 21 days prior to enrollment:\r\n\r\n               -  Absolute neutrophil count (ANC) <1000 cells/mm^3\r\n\r\n               -  Platelets <100,000  10^9/L, or <70  10^9/L if thrombocytopenia is considered by\r\n                  the investigator to be due to myeloma infiltration of bone marrow\r\n\r\n               -  Aspartate aminotransferase [serum glutamic oxaloacetic transaminase] (AST [SGOT])\r\n                  or alanine aminotransferase [serum glutamic-pyruvic transaminase] (ALT [SGPT])\r\n                  >2 the upper limit of normal (ULN)\r\n\r\n               -  Serum creatinine >2 mg/dL (>176.8 mol/L); if the rise in creatinine is related\r\n                  to myeloma and there has been demonstrated a response to hydration, the subject\r\n                  may be enrolled.\r\n\r\n          -  Myocardial infarction within 6 months prior to enrollment or New York Hospital\r\n             Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled\r\n             ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or\r\n             significant conduction system abnormalities in the opinion of the investigator. Prior\r\n             to study entry, any abnormality on electrocardiogram at screening must be determined\r\n             and documented by the investigator as not medically relevant.\r\n\r\n          -  Any condition, including laboratory abnormalities, that in the opinion of the\r\n             Investigator places the patient at unacceptable risk if he/she were to participate in\r\n             the study. This includes but is not limited to serious medical conditions or\r\n             psychiatric illness likely to interfere with participation in this clinical study.\r\n\r\n          -  Prior malignancy except for adequately treated basal cell or squamous cell skin\r\n             cancer, in situ cervical cancer, in situ breast cancer, in situ prostate cancer, or\r\n             other cancer for which the patient has been disease-free for at least 3 years.\r\n\r\n          -  Female who is pregnant or breastfeeding. Female participants of childbearing potential\r\n             must have a negative pregnancy test with a sensitivity of at least 50 mIU/mL during\r\n             Screening.\r\n\r\n          -  Use of any investigational drugs within 30 days before randomization.\r\n      ","sponsor":"Millennium Pharmaceuticals, Inc.","sponsor_type":"Industry","conditions":"Multiple Myeloma","interventions":[{"intervention_type":"Drug","name":"Drug: Bortezomib","description":"Bortezomib bolus intravenous (IV) injection"},{"intervention_type":"Drug","name":"Drug: Dexamethasone","description":"Dexamethasone for oral administration"},{"intervention_type":"Drug","name":"Drug: Melphalan","description":"Melphalan for oral administration"},{"intervention_type":"Drug","name":"Drug: Prednisone","description":"Prednisone for oral administration"},{"intervention_type":"Drug","name":"Drug: Thalidomide","description":"Thalidomide for oral administration"}],"outcomes":[{"outcome_type":"primary","measure":"Progression Free Survival (PFS)","time_frame":"From randomization until disease progression. Median follow-up time was 43 months.","description":"PFS is defined as the time from randomization to disease progression or death, whichever occurs first. Participants who did not progress and were still alive at the cut-off date were censored at the date of last contact. Response was assessed by the Investigator using the International Myeloma Working Group (IMWG) uniform response criteria.\r\nProgressive disease requires 1 of the following:\r\nIncrease of ≥ 25% from nadir in:\r\nSerum M-component (absolute increase ≥ 0.5 g/dl)\r\nUrine M-component (absolute increase ≥ 200 mg/24 hours)\r\nIn patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/dl)\r\nBone marrow plasma cell percentage (absolute % ≥ 10%)\r\nDevelopment of new or increase in the size of existing bone lesions or soft tissue plasmacytomas.\r\nDevelopment of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease"},{"outcome_type":"secondary","measure":"Percentage of Participants With an Overall Response","time_frame":"Response assessed every other cycle for up to 13 cycles (49 weeks).","description":"Overall response defined as a best overall response of complete response (CR), very good partial response (VGPR) or partial response (PR), assessed by the Investigator using the IMWG uniform response criteria.\r\nCR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow.\r\nVGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours (h).\r\nPR requires 1 of the following:\r\n≥50% reduction of serum M-protein and 24-h urinary M-protein by ≥ 90% or to <200 mg/24 h, or\r\nIf M-protein not measurable, a ≥50% decrease in the difference between involved and uninvolved FLC levels, or\r\nIf FLC not measurable, a ≥ 50% reduction in plasma cells, provided baseline bone marrow plasma cell percentage was ≥30%.\r\nIf present at baseline, a ≥50% reduction in the size of soft tissue plasmacytomas is also required."},{"outcome_type":"secondary","measure":"Percentage of Participants With a Complete Response","time_frame":"Response assessed every other cycle, for up to 13 cycles (49 weeks).","description":"Participants with a best overall response of complete response, defined as negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow. Response was assessed by the Investigator using the IMWG uniform response criteria."},{"outcome_type":"secondary","measure":"Percentage of Participants With a Complete Response or a Very Good Partial Response","time_frame":"Response assessed every other cycle for up to 13 cycles (49 weeks).","description":"Complete response is defined by negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow.\r\nVery good partial response is defined by serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours.\r\nResponse was assessed by the Investigator using the IMWG uniform response criteria."},{"outcome_type":"secondary","measure":"Duration of Response","time_frame":"From first documented response until disease progression. Median follow-up time was 43 months.","description":"Duration of response is defined in participants with an overall response as the time between first documentation of response and disease progression. Responders without disease progression were censored at the last clinical assessment of response."},{"outcome_type":"secondary","measure":"Overall Survival","time_frame":"From randomization until death. Median follow-up time was 43 months.","description":"Overall survival is defined as the time between randomization and death. Participants still alive at the cutoff date or lost to follow-up were censored at the date of last contact."},{"outcome_type":"secondary","measure":"Time to Alternative Therapy","time_frame":"From randomization until alternative therapy. Median follow-up time was 43 months.","description":"Time to alternative therapy is defined as the time between randomization and alternative therapy. Participants who did not receive alternative therapy were censored at the time of last contact."},{"outcome_type":"secondary","measure":"Change From Baseline in EORTC QLQ-C30 - Global Health Status","time_frame":"Baseline and Day 1 of Cycles 3, 5, 7, 9, 11 and 13","description":"The European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).\r\nThe EORTC QLQ-C30 Global Health Status/QOL Scale is scored between 0 and 100, where higher scores indicate better Global Health Status/QOL. Negative changes from baseline indicate deterioration in QOL or functioning and positive changes indicate improvement."}]}
{"nct_id":"NCT01173588","start_date":"2007-06-30","phase":"Phase 3","enrollment":174,"brief_title":"Effect of Yogurt Added With Bifidobacteria and Soluble Fiber on Bowel Function.","official_title":"Effect of Yogurt Added With Bifidobacteria and Soluble Fiber on Bowel Function: A Randomized, Double-blind, Longitudinal Controlled Study in Mexican Adult.","primary_completion_date":"2007-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-02-29","last_update":"2010-08-02","description":"The aim of this study was to evaluate the effect of the consumption of yogurt added with bifidobacteria and soluble fiber on gastrointestinal function of healthy adults. A product as herein described is expected to improve gastrointestinal function and maintain the intestinal microflora balance of healthy subjects and perhaps of patients with altered bowel functions.","other_id":"PEE-001-2007","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  age between 18 and 55 years,\r\n\r\n          -  be free of known gastrointestinal diseases,\r\n\r\n          -  desist of consuming prebiotic and/or probiotic-containing foods or dietary supplements\r\n             during the entire duration of the study,\r\n\r\n          -  agree to avoid any medication that produced changes in gastrointestinal function,\r\n             diarrhea or constipation until completion of the study,\r\n\r\n          -  be willing to complete all necessary study questionnaires,\r\n\r\n          -  accept voluntary participation and sign a written informed consent before inclusion in\r\n             the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  subjects receiving any kind of treatment that may had altered bowel function;\r\n\r\n          -  intake of laxatives,\r\n\r\n          -  a concomitant sever gastrointestinal disease;\r\n\r\n          -  that were consuming probiotics and/or prebiotics-containing foods or dietary\r\n             supplements within the two previous weeks;\r\n\r\n          -  subjects were also excluded if they had received any antimicrobial medication during\r\n             the previous 2 months.\r\n      ","sponsor":"Instituto Lala","sponsor_type":"Industry","conditions":"Inflammatory Bowel Diseases","interventions":[{"intervention_type":"Other","name":"Other: yogurt added with bifidobacteria and soluble fiber (YBF)","description":"Yogurt in YBF was added with 1.5 g inulin/100 g and 5 x 107 CFU of bifidobacterium/mL"}],"outcomes":[{"outcome_type":"primary","measure":"Stools Frequency","time_frame":"0, 1, 2, 3, 4, 5 weeks","description":"Stools frequency was reported daily as follows: 0: zero 1= once, 2= twice, 3=three times, 4= four or more times"},{"outcome_type":"secondary","measure":"Consistency of stools","time_frame":"0, 1, 2, 3, 4, 5 weeks","description":"Consistency of stools was scored according to the following scale: 1= watery and liquid, 2= soft and unformed, 3= soft and formed, and 4= hard and dry."},{"outcome_type":"secondary","measure":"Difficulty of defecation","time_frame":"0,1,2,3,4,5","description":"Difficulty of defecation was evaluated as 1= very easy, 2= easy, 3= hard, 4= very hard."},{"outcome_type":"secondary","measure":"Abdominal distension","time_frame":"0,1,2,3,4,5","description":"Abdominal distension was evaluated as 1= no symptoms, 2= slight symptoms that did not influence daily activities, 3= moderate symptoms that could influence daily activities, 4= severe symptoms that affected daily activities."},{"outcome_type":"secondary","measure":"Flatulence","time_frame":"0,1,2,3,4,5","description":"Flatulence was evaluated as 1= no symptoms, 2= slight symptoms that did not influence daily activities, 3= moderate symptoms that could influence daily activities, 4= severe symptoms that affected daily activities."},{"outcome_type":"secondary","measure":"Abdominal pain","time_frame":"0,1,2,3,4,5 weeks","description":"Abdominal pain was evaluated as 1= no symptoms, 2= slight symptoms that did not influence daily activities, 3= moderate symptoms that could influence daily activities, 4= severe symptoms that affected daily activities."}]}
{"nct_id":"NCT00566761","start_date":"2007-06-30","phase":"Phase 4","enrollment":10,"brief_title":"Treatment of Bevacizumab and Triamcinolone in Treatment or Macular Edema Secondary to CRVO","official_title":"Combined Treatment of Intravitreous Bevacizumab and Triamcinolone for the Treatment or Macular Edema Secondary to Central Retinal Vein Occlusion","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2008-03-31","last_update":"2007-12-04","description":"Treatment of macular edema secondary to central retinal vein occlusion is more effective with combined therapy of bevacizumab and triamcinolone than bevacizumab alone.","other_id":"MECRVO","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Macular edema secondary to central retinal vein occlusion\r\n\r\n          -  BCVA worse than 20/40\r\n\r\n          -  Central macular >250 mc with OCT\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Diabetic retinopathy or other retinopathy\r\n\r\n          -  Media opacity that does not allow following\r\n\r\n          -  steroid responder\r\n\r\n          -  diagnosed glaucoma or IOP > 21 mmHg\r\n      ","sponsor":"Asociacin para Evitar la Ceguera en Mxico","sponsor_type":"Other","conditions":"Macular Edema|Central Retinal Vein Occlusion","interventions":[{"intervention_type":"Drug","name":"Drug: bevacizumab and triamcinolone","description":"three applications monthly administrated of bevacizumab 2.5mg for group 1 and bevacizumab 2.5 mg + triamcinolone 4mg first dose followed by two of bevacizumab alone for the group 2"}],"outcomes":[{"outcome_type":"primary","measure":"Changes in Best corrected visual acuity and macular edema measured with OCT","time_frame":"Follow up to 3 , 6 and 12 months"},{"outcome_type":"secondary","measure":"Report treatment complications","time_frame":"12 month"}]}
{"nct_id":"NCT00524680","start_date":"2007-06-30","phase":"Phase 2","enrollment":148,"brief_title":"Vitamin D in Treating Patients With Prostate Cancer","official_title":"Study of Serum 25(OH) D3 Level Variability in Response to Different Doses of Oral Vitamin D Supplementation in Prostate Cancer Patients","primary_completion_date":"2011-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-03-31","last_update":"2015-11-01","description":"RATIONALE: Vitamin D may be effective in treating patients with prostate cancer. PURPOSE: This randomized phase II trial is studying how well 4 different doses of vitamin D works in treating patients with prostate cancer.","other_id":"CDR0000562742","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":120,"population":"","criteria":"\n        DISEASE CHARACTERISTICS:\r\n\r\n          -  Histologically confirmed adenocarcinoma of the prostate\r\n\r\n          -  25(OH) D3 level < 80 ng/mL\r\n\r\n        PATIENT CHARACTERISTICS:\r\n\r\n        Inclusion criteria:\r\n\r\n          -  ECOG performance status 0-2\r\n\r\n          -  Creatinine  2.0 mg/dL\r\n\r\n          -  Corrected serum calcium  10.5 mg/dL\r\n\r\n        Exclusion criteria:\r\n\r\n          -  History of malabsorption syndrome (e.g., pancreatic insufficiency, celiac disease, or\r\n             tropical sprue)\r\n\r\n          -  Hypersensitivity to cholecalciferol or one of its components\r\n\r\n        PRIOR CONCURRENT THERAPY:\r\n\r\n          -  No other concurrent vitamin D supplementation\r\n      ","sponsor":"Roswell Park Cancer Institute","sponsor_type":"Other","conditions":"Prostate Cancer","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: cholecalciferol","description":"Given orally"}],"outcomes":[{"outcome_type":"primary","measure":"Pattern of Response of Serum 25(OH) D3 Levels","time_frame":"Baseline, at 1, 3, 6 months","description":"Change from Baseline in Serum 25(OH) D3 Levels at 1, 3, and 6 Months at dose levels 4000, 6000, 8000 and 10000 IU. Statistical analysis was done using one sample t-test."},{"outcome_type":"secondary","measure":"Pattern of Response of Parathormone","time_frame":"Baseline, at 1, 3, 6 months","description":"Change from Baseline in PTH Levels at 1, 3, and 6 Months at dose levels 4000, 6000, 8000 and 10000 IU. Statistical analysis was done using one sample t-test."},{"outcome_type":"secondary","measure":"Toxicity","time_frame":"Baseline, at 1, 3 and 6 months","description":"Number of treated patients that had serious adverse events."},{"outcome_type":"secondary","measure":"Occurrence of Infections, Deep Vein Thrombosis, Vascular Events, and Falls","time_frame":"Baseline, at 1, 3 ,6 months","description":"Number of participant with occurrence of infections, deep venous thrombosis, vascular events and falls"}]}
{"nct_id":"NCT00472628","start_date":"2007-05-31","enrollment":0,"brief_title":"Multi-marker INDex for the Risk Assessment of Sepsis in the Emergency departmenT (MINDSET)","official_title":"Multi-marker Index for the Risk Assessment of Sepsis in the Emergency Department","study_type":"Observational","rec_status":"Withdrawn","completion_date":"2007-08-31","last_update":"2015-07-21","description":"The purpose of the study is to procure blood samples from patients 18 years of age who present to the Emergency Department (ED) with at least two of the diagnostic criteria for sepsis. Samples obtained upon enrollment will be used for future testing of the Triage Sepsis Panel and other biomarkers.","other_id":"BSTE-0501 - CLOSED","time_perspective":"Prospective","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female 18 years of age or older\r\n\r\n          -  Presenting to the emergency department (ED) for evaluation and who can be enrolled\r\n             within 6 hours of initial ED evaluation\r\n\r\n          -  Exhibiting two or more of any diagnostic criteria for sepsis\r\n\r\n          -  Willing and able to comply with study procedures, including follow-up telephone\r\n             contact (or in-house assessment) on Study Days 3, 14, and 28\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Age < 18 years\r\n\r\n          -  Participation in any interventional clinical study within the previous 30 days\r\n\r\n          -  Status-post cardiac arrest (within the past month)\r\n\r\n          -  Moribund or with active \"Do Not Resuscitate\" or \"Comfort Care Only\" status\r\n\r\n          -  Prisoners or other institutionalized or vulnerable individuals\r\n\r\n          -  Already a hospital in-patient\r\n\r\n          -  Unwilling or unlikely to comply with study procedures or to be reachable by telephone\r\n             (or in person) for Day 3, 14, and 28 status assessments if discharged\r\n      ","sponsor":"Biosite","sponsor_type":"Other","conditions":"Sepsis","interventions":[{"intervention_type":"Procedure","name":"Procedure: Blood samples collected"}],"outcomes":{}}
{"nct_id":"NCT00496314","start_date":"2007-05-31","enrollment":30,"brief_title":"Physician's Comfort Level and Satisfaction Study With The e2TM Collector Compared to the Spatula/CytoBrush Technique","official_title":"Clinical Study Assessing Physician's Comfort Level and Satisfaction When Using The e2TM Cervical Cell Collector Compared to the Standard Spatula/CytoBrush Technique","study_type":"Observational","rec_status":"Terminated","completion_date":"2008-01-31","last_update":"2008-06-17","description":"A study which assesses the physician's comfort level and satisfaction when using the e2TM Collector compared to the Spatula/SytoBrush technique.","other_id":"12-20-06","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Every Physician who will participate in the two CytoCore prospective studies assessing\r\n             the safety and efficacy of the e2TM Collector\r\n\r\n          -  Each physician will have used the Collector 15 - 25 times\r\n\r\n          -  Each physician will have signed the Consent form prior to using the Collector for the\r\n             first time.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  None (commensurate with the above inclusion conditions.)\r\n      ","sponsor":"CytoCore, Inc.","sponsor_type":"Industry","conditions":"Cervical Cell Collection","interventions":[{"intervention_type":"Device","name":"Device: e2TM Cervical Cell Collector"}],"outcomes":[{"outcome_type":"primary","measure":"Physician comfort level and satisfaction when using the e2TM Collector compared to the standard spatula/cytobrush.","time_frame":"Each physician will be surveyed after first and last use of the e2TM collector as well as three more times spaced at near regular intervals in between."}]}
{"nct_id":"NCT00776685","start_date":"2007-05-31","phase":"Phase 2/Phase 3","enrollment":3190,"brief_title":"Adventure: Teacher Delivered Personality-targeted Interventions for Substance Misuse","official_title":"Cognitive Behavioral Interventions That Target Personality Risk for Substance Abuse and Mental Illness: Delivery by Educational Professionals","primary_completion_date":"2010-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-05-31","last_update":"2011-06-27","description":"Several personality factors have been shown to be associated with risk for alcohol and substance misuse, and differentiate substance abusers based on clinical profile, treatment response and susceptibility to other forms of mental illness. Personality-targeted interventions have been found to have significant preventative effects on onset and growth of drinking, binge-drinking and drinking problems in adolescents attending mainstream schools (Conrod, Castellanos & Mackie, 2008). The interventions concurrently reduced personality-specific emotional and behavioural problems (Castellanos & Conrod, 2006), and prevented the onset and escalation of drug-use over a two-year period (Conrod, Castellanos-Ryan & Strang, 2010). This cluster randomised controlled trial aims to examine whether these results can be replicated when interventions are delivered by trained educational professionals. In addition, the trial will evaluate the broader impact of the programme on cigarette smoking, school attendance, academic achievement and school-wide behaviours.","other_id":"Adventure","allocation":"Randomized","intervention_model":"Factorial Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":13,"maximum_age":16,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Secondary school student\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  None\r\n      ","sponsor":"King's College London","sponsor_type":"Other","conditions":"Alcohol Abuse|Drug Abuse|Depression|Panic Disorder|Conduct Disorder","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Personality-targeted interventions","description":"Motivational and cognitive behavioural interventions targeting four personality profiles. 2 90 minute group sessions with personality-matched peers facilitated by a trained teacher and co-facilitator"}],"outcomes":[{"outcome_type":"primary","measure":"Binge drinking frequency","time_frame":"2 years","description":"Frequency in the past 6 months that subject reported drinking 5 or more alcoholic beverages (4 or more for girls) on one drinking occasion."},{"outcome_type":"primary","measure":"Drinking frequency","time_frame":"2 years","description":"Past six months frequency of drinking"},{"outcome_type":"primary","measure":"drinking quantity","time_frame":"2 years","description":"Average number of alcoholic beverages consumed on a typical drinking occasion in the past six months"},{"outcome_type":"primary","measure":"Drinking problems","time_frame":"2 years","description":"number of drinking problems reported on an abbreviated version of the Rutger's Alcohol Problem Index."},{"outcome_type":"primary","measure":"illicit drug use events","time_frame":"2 years","description":"Time to onset of illicit drug use"},{"outcome_type":"secondary","measure":"Emotional and behavioural problems, targeted and school-wide effects","time_frame":"2 years","description":"Psychiatric symptoms (depression, panic anxiety, antisocial behaviours), coping skills, motives for drinking, school attendance and attainment, in-class behaviours assessed using the Strengths and Difficulties Questionnaire and the Brief Symptom Inventory."}]}
{"nct_id":"NCT00134576","start_date":"2007-05-31","phase":"N/A","enrollment":150,"brief_title":"Automated Assessment of Mental Health in the Workplace","official_title":"Automated Assessment of Mental Health in the Workplace","primary_completion_date":"2008-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-01-31","last_update":"2010-06-03","description":"The purpose of this study is to design, refine, and test for the effectiveness of a computer-based telephone system (Telephone-Linked Communications for Detection of Mental Health Disorders in the Workplace; TLC-Detect) that will screen workers for mental health distress; educate them about seeking treatment; and follow up with them over a 6 month period.","other_id":"R01DP000116","allocation":"Randomized","intervention_model":"Factorial Assignment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Employment with benefits at Boston Medical Center, Boston University, or Florida Power\r\n             and Light Company\r\n\r\n          -  Ability to speak and understand conversational English\r\n\r\n          -  > 18 years of age\r\n\r\n          -  Access to a touch-tone telephone\r\n\r\n          -  Screen positive for the World Health Organization (WHO)-5 Well-Being Index\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Being under treatment (medication or therapy) for a mental health disorder\r\n\r\n          -  Taking medication for a serious/major medical disorder that interferes with normal\r\n             life\r\n\r\n          -  Taking medication prescribed for mental health treatment on a daily basis\r\n\r\n          -  Diagnosed with schizophrenia\r\n\r\n          -  Planning to go on leave for over 6 months\r\n      ","sponsor":"Boston Medical Center","sponsor_type":"Other","conditions":"Mental Disorders","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Computer Assisted Education for Behavioral Change","description":"TLC-Detect will provide subjects in the intervention group with information about each diagnosed mental health disorder. TLC-Detect will then give the Treatment Module and will tell the intervention subjects that it will call back in one month for a follow-up or the next week if a subject is comorbid with other disorders."}],"outcomes":[{"outcome_type":"primary","measure":"Absenteeism and presentism (functionality at work), measured every three months for 6 months","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Treatment status, timing of measurement depends upon symptom severity","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Health status measured every three months for 6 months","time_frame":"6 months"}]}
{"nct_id":"NCT00475293","start_date":"2007-05-31","phase":"Phase 2","enrollment":85,"brief_title":"Panitumumab in Combination With Irinotecan Chemotherapy as 2nd-line Therapy in Subjects With mCRC","official_title":"A Phase 2 Clinical Trial of Panitumumab in Combination With Irinotecan Chemotherapy as 2nd-line Therapy in Subjects With Metastatic Colorectal Cancer","primary_completion_date":"2010-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-03-31","last_update":"2013-09-13","description":"The purpose of this study is to assess the objective response rate (ORR) when panitumumab is administered in combination with irinotecan as 2nd-line therapy in subjects with previously treated metastatic colorectal cancer (mCRC).","other_id":"TTD-06-04","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Man or woman > 18 years of age\r\n\r\n          -  Competent to comprehend, sign, and date an IEC-approved informed consent form\r\n\r\n          -  Histologically or cytologically-confirmed metastatic adenocarcinoma of the colon or\r\n             rectum.\r\n\r\n          -  Radiographically documented disease progression per modified RECIST criteria either\r\n             while receiving or  6 months after the last dose of prior first-line chemotherapy for\r\n             mCRC\r\n\r\n          -  At least 1 uni-dimensionally measurable lesion of at least 20 mm per modified RECIST\r\n             criteria.\r\n\r\n          -  If subject has prior history of cancer other than colorectal carcinoma, basal cell\r\n             carcinoma, or cervical carcinoma in situ, then subject must not have had treatment or\r\n             active disease within 5 years.\r\n\r\n          -  Prior radiotherapy is acceptable.\r\n\r\n          -  One and only one prior chemotherapy regimen for mCRC consisting of first-line\r\n             fluoropyrimidine-based chemotherapy.\r\n\r\n          -  ECOG performance status of 0, 1 or 2\r\n\r\n          -  Life expectancy  3 months\r\n\r\n          -  Hematologic function:ANC > 1.5 x 109/L, Platelet count > 100 x 109/L, Hemoglobin > 10\r\n             g/dL\r\n\r\n          -  Renal function: Creatinine < 1.5 mg/dL\r\n\r\n          -  Hepatic function: AST and ALT < 3 x ULN (if liver metastases < 5 x ULN)\r\n\r\n          -  Bilirubin < 2 x ULN\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  No more than one prior chemotherapy regimen for mCRC consisting of first-line\r\n             fluoropyrimidine-based chemotherapy. (Prior adjuvant fluoropyrimidine-based\r\n             chemotherapy is allowed)\r\n\r\n          -  Prior systemic therapy for the treatment of metastatic colorectal carcinoma with the\r\n             exception of adjuvant fluoropyrimidine-based chemotherapy given at least 6 months\r\n             prior to enrolment.\r\n\r\n          -  Systemic chemotherapy, hormonal therapy, immunotherapy or experimental or approved\r\n             proteins/antibodies (eg, bevacizumab)  30 days before inclusion\r\n\r\n          -  Unresolved toxicities from prior systemic therapy that, in the opinion of the\r\n             investigator, does not qualify the patient for inclusion\r\n\r\n          -  Central nervous system/brain metastases\r\n\r\n          -  Significant cardiovascular disease including unstable angina or myocardial infarction\r\n             within 6 months before initiating study treatment or a history of ventricular\r\n             arrhythmia\r\n\r\n          -  Prior anti-EGFr antibody therapy (eg, cetuximab) or treatment small molecule EGFr\r\n             tyrosine kinase inhibitors (eg, erlotinib)\r\n\r\n          -  History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial\r\n             pneumonitis or pulmonary fibrosis on baseline chest CT scan\r\n\r\n          -  Treatment for systemic infection within 14 days before initiating study treatment\r\n\r\n          -  Radiotherapy  14 days prior to inclusion. Patients must have recovered from all\r\n             radiotherapy-related toxicities\r\n\r\n          -  Active inflammatory bowel disease or other bowel disease causing chronic diarrhoea\r\n             (defined as > 4 loose stools per day)\r\n\r\n          -  History of Gilbert's syndrome or dihydropyrimidine deficiency\r\n\r\n          -  History of any medical condition that may increase the risks associated with study\r\n             participation or may interfere with the interpretation of the study results\r\n\r\n          -  Known positive test for human immunodeficiency virus infection, hepatitis C virus,\r\n             chronic active hepatitis B infection\r\n\r\n          -  subject allergic to the ingredients of the study medication or to Staphylococcus\r\n             protein A\r\n\r\n          -  Any co-morbid disease that would increase risk of toxicity\r\n\r\n          -  Any kind of disorder that compromises the ability of the subject to give written\r\n             informed consent and/or comply with the study procedures\r\n\r\n          -  Any investigational agent within 30 days before enrolment\r\n\r\n          -  Must not have had a major surgical procedure within 28 days of randomization\r\n\r\n          -  Subject who is pregnant or breast feeding\r\n\r\n          -  Woman or man of childbearing potential not consenting to use adequate contraceptive\r\n             precautions i.e. double barrier contraceptive methods\r\n\r\n          -  Subject unwilling or unable to comply with study requirements\r\n      ","sponsor":"Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)","sponsor_type":"Other","conditions":"Metastatic Colorectal Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Panitumumab and CPT-11","description":"Panitumumab will be administered by IV infusion on day 1 of each cycle just prior to the administration of chemotherapy. The starting panitumumab dose is 9 mg/kg\r\nIrinotecan: 350 or 300 mg/m2. day 1\r\nOne treatment cycle is defined as the 21 day period following the commencement of treatment with panitumumab + irinotecan plus additional time, as needed, for the resolution of irinotecan-related toxicities"}],"outcomes":[{"outcome_type":"primary","measure":"objective response rate","time_frame":"2007-2010"},{"outcome_type":"secondary","measure":"disease control rate, duration of response, time to response, progression-free survival, time to progression,time to treatment failure,duration of stable disease","time_frame":"2007-2010"},{"outcome_type":"secondary","measure":"adverse events","time_frame":"2007-2010"}]}
{"nct_id":"NCT00493870","start_date":"2007-05-29","phase":"Phase 3","enrollment":1296,"brief_title":"TAC Versus TC for Adjuvant Breast Cancer","official_title":"Phase III Trial of TC Versus TAC in HER2-Negative Early Stage Breast Cancer Patients","primary_completion_date":"2015-05-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2019-05-31","last_update":"2018-10-01","description":"The purpose of this research study is to find out what effects (good and bad) TC or TAC has on early stage HER2- breast cancer.","other_id":"06090","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        A woman will be eligible for inclusion in this study if she meets all of the following\r\n        criteria:\r\n\r\n          -  Age >18 to <70 years old.\r\n\r\n          -  Has known ER and PR status\r\n\r\n          -  Has HER2 nonamplified disease, confirmed by FISH\r\n\r\n          -  Has known menopausal status (see Section 7.3 for criteria)\r\n\r\n          -  Has operable, histologically confirmed, Stage I, IIA, IIB, or IIIA, IIIB, or IIIC\r\n             invasive carcinoma of the breast. Bilateral synchronous breast cancer is allowable\r\n             provided that 1 primary meets the inclusion criteria.\r\n\r\n          -  Meets 1 of the 3 following criteria:\r\n\r\n               -  T1-3N1-3M0 if ER positive or negative\r\n\r\n               -  T2-3N0M0 if ER positive or negative\r\n\r\n               -  T1N0M0 if ER and PR negative\r\n\r\n          -  Has complete surgical resection of the primary breast tumor: either lumpectomy or\r\n             mastectomy with sentinel lymph node biopsy or axillary dissection, with clear margins\r\n             for both invasive and ductal carcinoma in situ (DCIS)\r\n\r\n          -  Has had no prior chemotherapy unless >5 years ago\r\n\r\n          -  Has an ECOG Performance Status (PS) 0-1\r\n\r\n          -  Has laboratory values of: See protocol for specific details\r\n\r\n          -  Has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) and alkaline\r\n             phosphatase (ALP) within the ranges shown below. In determining eligibility the more\r\n             abnormal of the 2 values (AST or ALT) should be used. See protocol for specific\r\n             details\r\n\r\n          -  Has normal cardiac function as evidenced by a LVEF >50%, but WNL by institutional\r\n             standard by multiple gated acquisition (MUGA) scan. An echocardiogram (ECHO) may be\r\n             used if MUGA is not available, but the same modality must be used consistently\r\n             throughout the study to evaluate LVEF. Ejection fraction as determined by ECHO must be\r\n             WNL by institutional standard.\r\n\r\n          -  Has no evidence of metastatic disease outside of breast by physical examination and\r\n             chest x-ray. Other scans if done as needed by the patient (eg, bone scan; abdominal,\r\n             chest CT; PET or PET/CT; ultrasound; or MRI should indicate no evidence of metastatic\r\n             disease\r\n\r\n          -  Has had baseline bilateral mammography\r\n\r\n          -  It has been <84 days since the date of definitive surgery (eg, mastectomy or, in the\r\n             case of a breast-sparing procedure, axillary dissection) with adequate wound healing,\r\n             as determined by the Treating Physician\r\n\r\n          -  Has a negative serum pregnancy test within 7 calendar days prior to registration\r\n             (female patients of childbearing potential [not surgically sterilized and between\r\n             menarche and 1 year postmenopause])\r\n\r\n          -  If fertile, patient has agreed to use an acceptable method of birth control (barrier\r\n             contraceptive only) to avoid pregnancy for the duration of the study and for a period\r\n             of 3 months thereafter\r\n\r\n          -  Has adequate tumor specimen available for FISH analysis of TOP2A status (See Appendix\r\n             VI).\r\n\r\n          -  Has signed a Patient Informed Consent Form\r\n\r\n          -  Has signed a Patient Authorization Form\r\n\r\n        Exclusion Criteria:\r\n\r\n        A woman will be excluded from this study if she meets any of the following criteria:\r\n\r\n          -  Has any evidence of metastatic disease following surgical resection of the primary\r\n             tumor including: positive surgical margins, staging work-up, or physical examination\r\n             suspicious for malignant disease\r\n\r\n          -  Has T4 disease (ie, patients with fixed tumors, peau d'orange skin changes, skin\r\n             ulcerations, or inflammatory changes)\r\n\r\n          -  Has Stage IV breast cancer (M1 disease on TNM staging system)\r\n\r\n          -  Has a history of severe hypersensitivity reaction to drugs formulated with polysorbate\r\n             80\r\n\r\n          -  Has had neoadjuvant chemotherapy for this breast cancer\r\n\r\n          -  Has ever had a myocardial infarction (MI) or has a history of heart failure,\r\n             uncontrolled angina, severe uncontrolled arrhythmias, pericardial disease, or\r\n             electrocardiographic evidence of acute ischemic changes\r\n\r\n          -  Is receiving concurrent immunotherapy, hormonal therapy (eg, tamoxifen, hormone\r\n             replacement therapy), or radiation therapy. Must discontinue prior to registering on\r\n             the study.\r\n\r\n          -  Is receiving concurrent investigational therapy or has received such therapy within\r\n             the past 30 calendar days\r\n\r\n          -  Has peripheral neuropathy >Grade 1\r\n\r\n          -  Has had a major organ allograft or condition requiring chronic immunosuppression (ie,\r\n             kidney, liver, lung, heart, bone marrow transplant, or autoimmune diseases). Patients\r\n             who have received corneal transplants or cadaver skin or bone transplants are\r\n             eligible.\r\n\r\n          -  Has a serious uncontrolled intercurrent medical or psychiatric illness, including\r\n             serious viral (including clinically defined AIDS), bacterial or fungal infection; or\r\n             history of uncontrolled seizures, or diabetes, or CNS disorders deemed by the Treating\r\n             Physician to be clinically significant, precluding informed consent\r\n\r\n          -  Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is\r\n             known to be HIV positive\r\n\r\n          -  Has a history of other malignancy within the last 5 years (except cured basal cell\r\n             carcinoma of skin, carcinoma in situ of uterine cervix, DCIS, which could affect the\r\n             diagnosis or assessment of any of the study drugs\r\n\r\n          -  In an obese patient to whom the Treating Physician would not be comfortable\r\n             administering full doses of study drugs as calculated by the BSA. Obese patients will\r\n             be treated based on actual body weight. Obese patients treated with full doses based\r\n             on actual BSA are eligible.\r\n\r\n          -  Is pregnant or breastfeeding\r\n\r\n          -  Is deemed unable to comply with requirements of study\r\n      ","sponsor":"US Oncology Research","sponsor_type":"Industry","conditions":"Breast Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Docetaxel","description":"Docetaxel 75 mg/m2 IV over 1 hour on Day 1 followed by cyclophosphamide"},{"intervention_type":"Drug","name":"Drug: Doxorubicin","description":" Doxorubicin 50 mg/m2 IV push over 5-15 minutes via sidearm through a running IV line on Day 1, followed by cyclophosphamide 500 mg/m2 IV over 15-30 minutes on Day 1, followed by docetaxel 75 mg/m2 IV over 1 hour on Day 1. Administer pegfilgrastim 6 mg SC on Day 2 (or filgrastim 5 mcg/kg SC per standard of care)."},{"intervention_type":"Drug","name":"Drug: Cyclophosphamide","description":"600 mg/m2 IV over 15-30 minutes on Day 1."}],"outcomes":[{"outcome_type":"primary","measure":"to compare the 3-year DFS of adjuvant TC versus TAC as treatment for early stage HER2-negative breast cancer.","time_frame":"3-year"}]}
{"nct_id":"NCT00508404","start_date":"2007-05-09","phase":"Phase 2","enrollment":154,"brief_title":"Panitumumab Plus FOLFIRI in First-line Treatment of Metastatic Colorectal Cancer","official_title":"A Single Arm Multicentre Phase II Study of Panitumumab in Combination With Irinotecan/5-fluorouracil/Leucovorin in Patients With Metastatic Colorectal Cancer","primary_completion_date":"2009-06-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-06-12","last_update":"2019-11-19","description":"To estimate the effect of KRAS mutation status (Wild-type versus Mutant) on objective response rate and other measures of efficacy for patients treated with panitumumab in combination with a chemotherapy regimen of irinotecan, 5-fluorouracil, and leucovorin (FOLFIRI) as first-line therapy for metastatic colorectal cancer (mCRC).","other_id":"20060314","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosed with histologically- or cytologically-confirmed metastatic adenocarcinoma of\r\n             the colon and/or rectum.\r\n\r\n          -  Measurable disease according to modified RECIST guidelines.\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.\r\n\r\n          -  Paraffin-embedded tissue or unstained tumour slides from primary or metastatic tumour\r\n             available for central lab analysis.\r\n\r\n          -  Adequate haematologic, renal, hepatic and metabolic function.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Central nervous system metastases.\r\n\r\n          -  Prior systemic therapy for the treatment of metastatic colorectal carcinoma with the\r\n             exception of adjuvant fluoropyrimidine-based chemotherapy given at least six months\r\n             prior to initiating study treatment.\r\n\r\n          -  Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (e.g. cetuximab)\r\n             or treatment with small molecule EGFr tyrosine kinase inhibitors (e.g. erlotinib).\r\n\r\n          -  Prior radiotherapy within 14 days prior to screening, and for which all signs of early\r\n             radiological toxicity have not abated.\r\n\r\n          -  Significant cardiovascular disease including unstable angina or myocardial infarction\r\n             within six months before initiating study treatment or a history of ventricular\r\n             arrhythmia.\r\n\r\n          -  History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial\r\n             pneumonitis or pulmonary fibrosis on baseline chest computed tomography (CT scan.\r\n\r\n          -  Active inflammatory bowel disease or other bowel disease causing chronic diarrhoea\r\n             (defined as > 4 loose stools per day).\r\n\r\n          -  History of Gilbert's syndrome or dihydropyrimidine deficiency.\r\n\r\n          -  Known positive test for human immunodeficiency virus infection, hepatitis C virus,\r\n             chronic active hepatitis B infection.\r\n\r\n          -  Any investigational agent within 30 days before initiation of study treatment.\r\n\r\n          -  Must not have had a major surgical procedure within 28 days prior to initiation of\r\n             study treatment.\r\n\r\n          -  Subject who is pregnant or breast-feeding.\r\n\r\n          -  Woman or man of childbearing potential not consenting to use adequate contraceptive\r\n             precautions during the course of the study and for six months after the last study\r\n             drug administration for women, and one month for men.\r\n\r\n               -  Other protocol specified criteria and specific details may apply.\r\n      ","sponsor":"Amgen","sponsor_type":"Industry","conditions":"Metastatic Colorectal Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Panitumumab","description":"Administered by intravenous infusion"},{"intervention_type":"Drug","name":"Drug: FOLFIRI","description":"FOLFIRI chemotherapy was initiated on Day 1 of each treatment cycle at the following starting doses: irinotecan 180 mg/m, leucovorin 400 mg/m, 5-fluorouracil bolus 400 mg/m, 5-fluorouracil infusion 2400 mg/m."}],"outcomes":[{"outcome_type":"secondary","measure":"Progression-free Survival","time_frame":"From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.","description":"Progression-free survival is the time from the date of enrollment to the date of first observed progression or death, whichever comes first. Participants who were alive and did not progress by the analysis data cut-off date were censored at the last evaluable disease assessment date. Progression-free survival was analyzed using Kaplan-Meier methods."},{"outcome_type":"primary","measure":"Objective Response Rate","time_frame":"Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks","description":"Objective response rate is defined as the percentage of participants with a best response of complete response or partial response. Disease assessments are based on investigator review of scans using modified Response Evaluation Criteria in Solid Tumors (RECIST) V1.0 criteria. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Participants with no post-baseline assessment were considered non-responders.\r\nComplete Response (CR): disappearance of all target and non-target lesions and no new lesions.\r\nPartial Response (PR): At least a 30% decrease in the size of target lesions with no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions but persistence of 1 or more non-target lesions not qualifying for either CR or progressive disease (PD) and no new lesions."},{"outcome_type":"secondary","measure":"Objective Response by 17 Weeks","time_frame":"Up to Week 17","description":"The percentage of participants with a best response of complete response or partial response by Week 17. Disease assessments are based on investigator review of scans using modified RECIST V1.0 criteria. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Participants with no post-baseline assessment were considered non-responders."},{"outcome_type":"secondary","measure":"Disease Control Rate","time_frame":"Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks","description":"The percentage of participants whose best response was either a complete or partial response or stable disease, based on modified RECIST v1.0 criteria as assessed by the Investigator.\r\nStable diease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD of target lesions and no progression of existing non-target lesions and no new lesions, or, the persistence of 1 or more non-target lesions not qualifying for either CR or PD if no target lesions were identified at Baseline."},{"outcome_type":"secondary","measure":"Duration of Response","time_frame":"Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks.","description":"Duration of response was calculated only for those participants who had a confirmed complete or partial response, and is defined as the time from first confirmed response to first observed progression. For participants who responded and did not progress by the analysis data cut-off date, duration of response was censored at their last evaluable disease assessment date. Duration of response was analyzed using the Kaplan-Meier method."},{"outcome_type":"secondary","measure":"Time to Initial Objective Response","time_frame":"Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks.","description":"Time to response is the time from the date of enrollment to the date of first confirmed complete or partial response. Participants with a best response of stable disease at the analysis data cut-off date were censored at their last assessment of SD and participants with all other categories of best response were censored at the maximum observed time to a first confirmed response among all responders. Time to initial objective response was analyzed using Kaplan-Meier methods."},{"outcome_type":"secondary","measure":"Time to Disease Progression","time_frame":"From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.","description":"Time to progression is the time from the enrollment date to the date of first observed progression. For participants who had not progressed by the analysis data cutoff date, time to progressive disease was censored at their last evaluable disease assessment date. Time to disease progression was analyzed using Kaplan-Meier methods."},{"outcome_type":"secondary","measure":"Duration of Stable Disease","time_frame":"Tumor response was assessed at Week 8 and every 8 weeks to Week 48 and 3 monthly thereafter until disease progression; median follow-up time was 34 weeks.","description":"Duration of stable disease was calculated only for participants with a best response of stable disease and is defined as the time from enrollment to first observed PD. For participants who did not progress by the analysis data cut-off date, duration of SD was censored at their last evaluable disease assessment date. Duration of stable disease was estimated using Kaplan-Meier methods."},{"outcome_type":"secondary","measure":"Time to Treatment Failure","time_frame":"From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.","description":"Time to treatment failure is defined as the time from enrollment to the date the decision was made to end the treatment phase for any reason. For participants who remained in the treatment phase at the analysis data cut-off date, time to treatment failure was censored at the date of their last on-study assessment. Time to treatment failure was analyzed using Kaplan-Meier methods."},{"outcome_type":"secondary","measure":"Time to Disease Relapse Following Surgical Intervention","time_frame":"From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.","description":"Calculated only for those participants who underwent surgical intervention, and defined as the time from the date of first post-intervention radiographic disease assessment to the date of first observed PD. Participants with no post-intervention disease assessment had their time to relapse set to zero and censored in the analysis. Participants that had evidence of progression / recurrence at their first post-intervention disease assessment had a time to relapse of zero. For participants who had not progressed by the analysis data cut-off date, time to relapse was censored at the date of their last evaluable disease assessment. Time to relapse was analyzed using Kaplan-Meier metjhods."},{"outcome_type":"secondary","measure":"Resection Rate","time_frame":"From enrollment until the data cut-off date of 18 June 2009; median follow-up time was 34 weeks.","description":"The percentage of participants who underwent a surgical procedure that resulted in partial reduction or complete eradication of all metastatic disease."}]}
{"nct_id":"NCT00474942","start_date":"2007-04-30","enrollment":130,"brief_title":"Natural History of Apparent Mineralocorticoid Excess Syndrome","official_title":"Apparent Mineralocorticoid Excess Syndrome Natural History Clinical Protocol","primary_completion_date":"2013-11-30","study_type":"Observational","rec_status":"Completed","completion_date":"2013-11-30","last_update":"2015-12-11","description":"Apparent mineralocorticoid excess (AME) is a rare inherited disease that can cause severe high blood pressure and low blood potassium in children and adults. It is caused by abnormal hormone metabolism and can be fatal. This study will focus on the genetic basis, natural history, disease progression, and survival of people with AME.","other_id":"GCO 04-0474","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","population":"Individuals with apparent mineralocorticoid excess plus their family members","criteria":"\n        Inclusion Criteria for Participants with AME:\r\n\r\n          -  High blood pressure characterized by low plasma renin and serum aldosterone levels\r\n\r\n          -  Elevated urinary cortisol/cortisone metabolite ratio ([THF + 5aTHF]/THE)\r\n\r\n          -  Molecular genetic diagnosis of AME with two mutations of the HSD11B2 gene\r\n\r\n        Inclusion Criteria for Family Members without Genetic Diagnosis of AME:\r\n\r\n          -  Carrier of the HSD11B2 mutation that the AME participant has\r\n\r\n        Exclusion Criteria for All Participants:\r\n\r\n          -  Any other illness or condition that might interfere with study participation\r\n      ","sponsor":"Icahn School of Medicine at Mount Sinai","sponsor_type":"Other","conditions":"Apparent Mineralocorticoid Excess Syndrome","interventions":{},"outcomes":{}}
{"nct_id":"NCT01116960","start_date":"2007-04-30","enrollment":100,"brief_title":"How do Attitude About Pay for Performance Differ Among Different Anesthesia Care Provider and Over Time","official_title":"How do Attitute About Pay for Performance Differ Among Different Anesthesia Care Provider and Over Time","primary_completion_date":"2010-03-31","study_type":"Observational","rec_status":"Completed","completion_date":"2010-03-31","last_update":"2017-05-04","description":"The investigators hypothesize that common objections to P4P relate to potential loss of autonomy or concerns about adverse effects on patient care.","other_id":"13878","observational_model":"Other","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":24,"maximum_age":80,"population":"anesthesia care providers","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  All anesthesia care providers in the department\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  locum faculty members and CRNAs\r\n      ","sponsor":"University of Oklahoma","sponsor_type":"Other","conditions":"Attitude","interventions":{},"outcomes":{}}
{"nct_id":"NCT00523991","start_date":"2007-04-30","phase":"Phase 4","enrollment":457,"brief_title":"Trial Comparing Tiotropium Inhalation Capsules vs Placebo in Chronic Obstructive Pulmonary Disease (COPD).","official_title":"A 24 Week, Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of 18 MCG of Tiotropium Inhalation Capsules Administered by HandiHaler Once-daily Plus PRN Albuterol (Salbutamol) vs. Placebo Plus PRN Albuterol (Salbutamol) in Chronic Obstructive Pulmonary Disease Subjects Naive to Maintenance Therapy","primary_completion_date":"2010-07-31","study_type":"Interventional","rec_status":"Completed","last_update":"2014-05-20","description":"A 24 week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 18mcg of tiotropium inhalation capsules administered by Handihaler once daily plus Pro Re Nata (PRN) albuterol (salbutamol) vs. placebo plus PRN albuterol (salbutamol) in chronic obstructive pulmonary disease subjects naive to maintenance therapy.","other_id":"205.365","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":40,"maximum_age":80,"population":"","criteria":"\n        Inclusion criteria:\r\n\r\n        All subjects must have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD)\r\n        according to Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guideline\r\n        criteria:\r\n\r\n        post-bronchodilator Forced Expiratory Volume in one Second/Forced Vital Capacity (FEV1/FVC)\r\n        ratio < 70% (visit 1).\r\n\r\n        Subjects must be GOLD Stage II and have a post-bronchodilator FEV1 >50% and < 80% of\r\n        predicted normal (visit 1). Subjects must be current or ex-smokers with a smoking history\r\n        of >=10 pack years.\r\n\r\n        Subjects must have a Medical Research Council (MRC) dyspnea score >= 2.\r\n\r\n        Exclusion criteria:\r\n\r\n        Subjects who have been treated with maintenance medications for chronic respiratory disease\r\n        within six months prior to screening.\r\n\r\n        Subjects with significant diseases other than COPD. Subjects on chronic systemic\r\n        corticosteroids.\r\n\r\n        Subjects with any upper and/or lower respiratory tract infection or COPD exacerbation in\r\n        the 6 weeks prior to the initial visit 1 or during the screening period prior to visit 3\r\n        Subjects with a recent (past 6 months) myocardial infarction, any unstable or life\r\n        threatening cardiac arrhythmia requiring intervention or change in drug therapy during the\r\n        last year; or who have been hospitalized for cardiac failure during the past year.\r\n      ","sponsor":"Boehringer Ingelheim","sponsor_type":"Industry","conditions":"Pulmonary Disease, Chronic Obstructive","interventions":[{"intervention_type":"Drug","name":"Drug: tiotropium","description":"Oral inhalation once daily of 18mcg tiotropium via handihaler"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Oral inhalation once daily of placebo matching tiotropium via handihaler"}],"outcomes":[{"outcome_type":"secondary","measure":"Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 180 Minutes)","time_frame":"baseline, week 8, 180 minutes","description":"Change from baseline in forced expiratory volume in 1 second (at week 8, 180 minutes)"},{"outcome_type":"primary","measure":"Change From Baseline in Lung Function as Measured by the Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0-3h (AUC0-3h)","time_frame":"baseline, week 24","description":"Change = Week 24 Value - Baseline Value"},{"outcome_type":"secondary","measure":"Trough Forced Expiratory Volume in 1 Second (FEV1)(Baseline)","time_frame":"Baseline","description":"Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication."},{"outcome_type":"secondary","measure":"Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 8)","time_frame":"Baseline, week 8","description":"Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication."},{"outcome_type":"secondary","measure":"Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 16)","time_frame":"Baseline, week 16","description":"Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication."},{"outcome_type":"secondary","measure":"Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 24)","time_frame":"Baseline, week 24","description":"Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication."},{"outcome_type":"secondary","measure":"Peak Forced Expiratory Volume in 1 Second (Baseline)","time_frame":"Baseline","description":"Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1."},{"outcome_type":"secondary","measure":"Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 8)","time_frame":"Baseline, week 8","description":"Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit."},{"outcome_type":"secondary","measure":"Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16)","time_frame":"Baseline, week 16","description":"Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit."},{"outcome_type":"secondary","measure":"Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24)","time_frame":"Baseline, week 24","description":"Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit."},{"outcome_type":"secondary","measure":"Forced Expiratory Volume in 1 Second (Baseline, Pre-dose)","time_frame":"Baseline","description":"Forced expiratory volume in 1 second (baseline, pre-dose)"},{"outcome_type":"secondary","measure":"Forced Expiratory Volume in 1 Second (Baseline, 30 Minutes)","time_frame":"baseline, 30 minutes","description":"Forced expiratory volume in 1 second (baseline, 30 minutes)"},{"outcome_type":"secondary","measure":"Forced Expiratory Volume in 1 Second (Baseline, 60 Minutes)","time_frame":"baseline, 60 minutes","description":"Forced expiratory volume in 1 second (baseline, 60 minutes)"},{"outcome_type":"secondary","measure":"Forced Expiratory Volume in 1 Second (Baseline, 120 Minutes)","time_frame":"Baseline, 120 minutes","description":"Forced expiratory volume in 1 second (baseline, 120 minutes)"},{"outcome_type":"secondary","measure":"Forced Expiratory Volume in 1 Second (Baseline, 180 Minutes)","time_frame":"Baseline, 180 minutes","description":"Forced expiratory volume in 1 second (baseline, 180 minutes)"},{"outcome_type":"secondary","measure":"Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, Pre-dose)","time_frame":"baseline, week 8, pre-dose","description":"Change from baseline in forced expiratory volume in 1 second (at week 8, pre-dose)"},{"outcome_type":"secondary","measure":"Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 30 Minutes)","time_frame":"Baseline, week 8, 30 minutes","description":"Change from baseline in forced expiratory volume in 1 second (at week 8, 30 minutes)"},{"outcome_type":"secondary","measure":"Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 60 Minutes)","time_frame":"baseline, week 8, 60 minutes","description":"Change from baseline in forced expiratory volume in 1 second (at week 8, 60 minutes)"},{"outcome_type":"secondary","measure":"Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 120 Minutes)","time_frame":"baseline, week 8, 120 minutes","description":"Change from baseline in forced expiratory volume in 1 second (at week 8, 120 minutes)"},{"outcome_type":"secondary","measure":"Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 16, Pre-dose)","time_frame":"baseline, week 16, pre-dose","description":"Change from baseline in forced expiratory volume in 1 second (at week 16, pre-dose)"},{"outcome_type":"secondary","measure":"Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 30 Minutes)","time_frame":"Baseline, week 16, 30 minutes","description":"Change from baseline in peak forced expiratory volume in 1 second (at week 16, 30 minutes)"},{"outcome_type":"secondary","measure":"Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 60 Minutes)","time_frame":"baseline, week 16, 60 minutes","description":"Change from baseline in peak forced expiratory volume in 1 second (at week 16, 60 minutes)"},{"outcome_type":"secondary","measure":"Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 120 Minutes)","time_frame":"baseline, week 16, 120 minutes","description":"Change from baseline in peak forced expiratory volume in 1 second (at week 16, 120 minutes)"},{"outcome_type":"secondary","measure":"Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 180 Minutes)","time_frame":"baseline, week 16, 180 minutes","description":"Change from baseline in peak forced expiratory volume in 1 second (at week 16, 180 minutes)"},{"outcome_type":"secondary","measure":"Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, Pre-dose)","time_frame":"baseline, week 24, pre-dose","description":"Change from baseline in peak forced expiratory volume in 1 second (at week 24, pre-dose)"},{"outcome_type":"secondary","measure":"Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 30 Minutes)","time_frame":"baseline, week 24, 30 minutes","description":"Change from baseline in peak forced expiratory volume in 1 second (at week 24, 30 minutes)"},{"outcome_type":"secondary","measure":"Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 60 Minutes)","time_frame":"baseline, week 24, 60 minutes","description":"Change from baseline in peak forced expiratory volume in 1 second (at week 24, 60 minutes)"},{"outcome_type":"secondary","measure":"Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 120 Minutes)","time_frame":"baseline, week 24, 120 minutes","description":"Change from baseline in peak forced expiratory volume in 1 second (at week 24, 120 minutes)"},{"outcome_type":"secondary","measure":"Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 180 Minutes)","time_frame":"baseline, week 24, 180 minutes","description":"Change from baseline in peak forced expiratory volume in 1 second (at week 24, 180 minutes)"},{"outcome_type":"secondary","measure":"FVC AUC0-3 at Baseline","time_frame":"baseline","description":"Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h)"},{"outcome_type":"secondary","measure":"FVC AUC0-3 at Week 8 Minus Baseline","time_frame":"baseline, week 8","description":"Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) (week 8)"},{"outcome_type":"secondary","measure":"FVC AUC0-3 at Week 16 Minus Baseline","time_frame":"baseline, week 16","description":"Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h)(week 16)"},{"outcome_type":"secondary","measure":"FVC AUC0-3 at Week 24 Minus Baseline","time_frame":"baseline, week 24","description":"Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) (week 24)"},{"outcome_type":"secondary","measure":"Trough Forced Vital Capacity (Baseline)","time_frame":"baseline","description":"Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication."},{"outcome_type":"secondary","measure":"Change From Baseline in Trough Forced Vital Capacity (at Week 8)","time_frame":"baseline, week 8","description":"Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication."},{"outcome_type":"secondary","measure":"Change From Baseline in Trough Forced Vital Capacity (at Week 16)","time_frame":"baseline, week 16","description":"Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication."},{"outcome_type":"secondary","measure":"Change From Baseline in Trough Forced Vital Capacity (at Week 24)","time_frame":"baseline, week 24","description":"Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication."},{"outcome_type":"secondary","measure":"Peak Forced Vital Capacity (FVC) (Baseline)","time_frame":"baseline","description":"Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1."},{"outcome_type":"secondary","measure":"Change From Baseline in Peak Forced Vital Capacity (at Week 8)","time_frame":"baseline, week 8","description":"Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit."},{"outcome_type":"secondary","measure":"Change From Baseline in Peak Forced Vital Capacity (at Week 16)","time_frame":"baseline, week 16","description":"Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit."},{"outcome_type":"secondary","measure":"Change From Baseline in Peak Forced Vital Capacity (at Week 24)","time_frame":"baseline, week 24","description":"Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit."},{"outcome_type":"secondary","measure":"Forced Vital Capacity (Baseline, Pre-dose)","time_frame":"baseline","description":"Forced vital capacity (baseline, pre-dose)"},{"outcome_type":"secondary","measure":"Forced Vital Capacity (Baseline, 30 Minutes)","time_frame":"baseline, 30 minutes","description":"Forced vital capacity (baseline, 30 minutes)"},{"outcome_type":"secondary","measure":"Forced Vital Capacity (Baseline, 60 Minutes)","time_frame":"baseline, 60 minutes","description":"Forced vital capacity (baseline, 60 minutes)"},{"outcome_type":"secondary","measure":"Forced Vital Capacity (Baseline, 120 Minutes)","time_frame":"baseline, 120 minutes","description":"Forced vital capacity (baseline, 120 minutes)"},{"outcome_type":"secondary","measure":"Forced Vital Capacity (Baseline, 180 Minutes)","time_frame":"baseline, 180 minutes","description":"Forced vital capacity (baseline, 180 minutes)"},{"outcome_type":"secondary","measure":"Change From Baseline in Forced Vital Capacity (Week 8, Pre-dose)","time_frame":"baseline, week 8, pre-dose","description":"Change from baseline in forced vital capacity (week 8, pre-dose)"},{"outcome_type":"secondary","measure":"Change From Baseline in Forced Vital Capacity (Week 8, 30 Minutes)","time_frame":"baseline, week 8, 30 minutes","description":"Change from baseline in forced vital capacity (week 8, 30 minutes)"},{"outcome_type":"secondary","measure":"Change From Baseline in Forced Vital Capacity (Week 8, 60 Minutes)","time_frame":"baseline, week 8, 60 minutes","description":"Change from baseline in forced vital capacity (week 8, 60 minutes)"},{"outcome_type":"secondary","measure":"Change From Baseline in Forced Vital Capacity (Week 8, 120 Minutes)","time_frame":"baseline, week 8, 120 minutes","description":"Change from baseline in forced vital capacity (week 8, 120 minutes)"},{"outcome_type":"secondary","measure":"Change From Baseline in Forced Vital Capacity (Week 8, 180 Minutes)","time_frame":"baseline, week 8, 180 minutes","description":"Change from baseline in forced vital capacity (week 8, 180 minutes)"},{"outcome_type":"secondary","measure":"Change From Baseline in Forced Vital Capacity (Week 16, Pre-dose)","time_frame":"baseline, week 16, pre-dose","description":"Change from baseline in forced vital capacity (week 16, pre-dose)"},{"outcome_type":"secondary","measure":"Change From Baseline in Forced Vital Capacity (Week 16, 30 Minutes)","time_frame":"baseline, week 16, 30 minutes","description":"Change from baseline in forced vital capacity (week 16, 30 minutes)"},{"outcome_type":"secondary","measure":"Change From Baseline in Forced Vital Capacity (Week 16, 60 Minutes)","time_frame":"baseline, week 16, 60 minutes","description":"Change from baseline in forced vital capacity (week 16, 60 minutes)"},{"outcome_type":"secondary","measure":"Change From Baseline in Forced Vital Capacity (Week 16, 120 Minutes)","time_frame":"baseline, week 16, 120 minutes","description":"Change from baseline in forced vital capacity (week 16, 120 minutes)"},{"outcome_type":"secondary","measure":"Change From Baseline in Forced Vital Capacity (Week 16, 180 Minutes)","time_frame":"baseline, week 16, 180 minutes","description":"Change from baseline in forced vital capacity (week 16, 180 minutes)"},{"outcome_type":"secondary","measure":"Change From Baseline in Forced Vital Capacity (Week 24, Pre-dose)","time_frame":"baseline, week 24, pre-dose","description":"Change from baseline in forced vital capacity (week 24, pre-dose)"},{"outcome_type":"secondary","measure":"Change From Baseline in Forced Vital Capacity (Week 24, 30 Minutes)","time_frame":"baseline, week 24, 30 minutes","description":"Change from baseline in forced vital capacity (week 24, 30 minutes)"},{"outcome_type":"secondary","measure":"Change From Baseline in Forced Vital Capacity (Week 24, 60 Minutes)","time_frame":"baseline, week 24, 60 minutes","description":"Change from baseline in forced vital capacity (week 24, 60 minutes)"},{"outcome_type":"secondary","measure":"Change From Baseline in Forced Vital Capacity (Week 24, 120 Minutes)","time_frame":"baseline, week 24, 120 minutes","description":"Change from baseline in forced vital capacity (week 24, 120 minutes)"},{"outcome_type":"secondary","measure":"Change From Baseline in Forced Vital Capacity (Week 24, 180 Minutes)","time_frame":"baseline, week 24, 180 minutes","description":"Change from baseline in forced vital capacity (week 24, 180 minutes)"},{"outcome_type":"secondary","measure":"Albuterol Use p.r.n. (Baseline)","time_frame":"baseline","description":"Number of days that participants used albuterol prn per week"},{"outcome_type":"secondary","measure":"Change From Baseline in Albuterol Use p.r.n. - (Week 4)","time_frame":"baseline, week 4","description":"Difference in number of days that participants used albuterol prn per week between week 4 and baseline"},{"outcome_type":"secondary","measure":"Change From Baseline in Albuterol Use p.r.n. - (Week 8)","time_frame":"baseline, week 8","description":"Difference in number of days that participants used albuterol prn per week between week 8 and baseline"},{"outcome_type":"secondary","measure":"Change From Baseline in Albuterol Use p.r.n. -(Week 12)","time_frame":"baseline, week 12","description":"Difference in number of days that participants used albuterol prn per week between week 12 and baseline"},{"outcome_type":"secondary","measure":"Change From Baseline in Albuterol Use p.r.n. - (Week 16)","time_frame":"baseline, week 16","description":"Difference in number of days that participants used albuterol prn per week between week 16 and baseline"},{"outcome_type":"secondary","measure":"Change From Baseline in Albuterol Use p.r.n. -(Week 20)","time_frame":"baseline, week 20","description":"Difference in number of days that participants used albuterol prn per week between week 20 and baseline"},{"outcome_type":"secondary","measure":"Change From Baseline in Albuterol Use p.r.n. - (Week 24)","time_frame":"baseline, week 24","description":"Difference in number of days that participants used albuterol prn per week between week 24 and baseline"},{"outcome_type":"secondary","measure":"Number of Participants With Categorical Scores on Physician's Global Assessment (Baseline)","time_frame":"baseline","description":"The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered.\r\nRange: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent."},{"outcome_type":"secondary","measure":"Number of Participants With Categorical Scores on Physician's Global Assessment (Week 12)","time_frame":"week 12","description":"The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered.\r\nRange: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent."},{"outcome_type":"secondary","measure":"Number of Participants With Categorical Scores on Physician's Global Assessment (Week 24)","time_frame":"week 24","description":"The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered.\r\nRange: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent."},{"outcome_type":"secondary","measure":"Number of Participants With Categorical Scores on Patient's Global Assessment (Baseline)","time_frame":"baseline","description":"The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities.\r\nRange: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent."},{"outcome_type":"secondary","measure":"Number of Participants With Categorical Scores on Patient's Global Assessment (Week 12)","time_frame":"week 12","description":"The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities.\r\nRange: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent."},{"outcome_type":"secondary","measure":"Number of Participants With Categorical Scores on Patient's Global Assessment (Week 24)","time_frame":"week 24","description":"The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities.\r\nRange: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent."},{"outcome_type":"secondary","measure":"Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Baseline)","time_frame":"baseline","description":"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.\r\nAbsenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment."},{"outcome_type":"secondary","measure":"Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 4)","time_frame":"baseline, week 4","description":"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 8)","time_frame":"baseline, week 8","description":"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 12)","time_frame":"baseline, week 12","description":"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 16)","time_frame":"baseline, week 16","description":"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 20)","time_frame":"baseline, week 20","description":"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 24)","time_frame":"baseline, week 24","description":"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline."},{"outcome_type":"secondary","measure":"Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health","time_frame":"baseline","description":"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.\r\nAbsenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment."},{"outcome_type":"secondary","measure":"Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 4)","time_frame":"baseline, week 4","description":"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 8)","time_frame":"baseline, week 8","description":"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 12)","time_frame":"baseline, week 12","description":"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 16)","time_frame":"baseline, week 16","description":"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 20)","time_frame":"baseline, week 20","description":"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 24)","time_frame":"baseline, week 24","description":"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline."},{"outcome_type":"secondary","measure":"Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Baseline)","time_frame":"baseline","description":"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.\r\nAbsenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment."},{"outcome_type":"secondary","measure":"Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 4)","time_frame":"baseline, week 4","description":"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 8)","time_frame":"baseline, week 8","description":"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 12)","time_frame":"baseline, week 12","description":"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 16)","time_frame":"baseline, week 16","description":"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 20)","time_frame":"baseline, week 20","description":"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 24)","time_frame":"baseline, week 24","description":"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline."},{"outcome_type":"secondary","measure":"Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Baseline)","time_frame":"baseline","description":"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.\r\nAbsenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment."},{"outcome_type":"secondary","measure":"Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 4)","time_frame":"baseline, week 4","description":"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 8)","time_frame":"baseline, week 8","description":"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 12)","time_frame":"baseline, week 12","description":"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 16)","time_frame":"baseline, week 16","description":"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 20)","time_frame":"baseline, week 20","description":"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 24)","time_frame":"baseline, week 24","description":"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline."},{"outcome_type":"secondary","measure":"Physical Activity (Light Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day","time_frame":"baseline","description":"Light intensity is less than three metabolic equivalents.\r\nMetabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.\r\nln in measure value unit means natural logarithm."},{"outcome_type":"secondary","measure":"Change From Baseline in Physical Activity (Light Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day","time_frame":"baseline, week 4","description":"Light intensity is less than three metabolic equivalents\r\nMetabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.\r\nln in measure value unit means natural logarithm"},{"outcome_type":"secondary","measure":"Change From Baseline in Physical Activity (Light Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day","time_frame":"baseline, week 8","description":"Light intensity is less than three metabolic equivalents\r\nMetabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.\r\nln in measure value unit means natural logarithm"},{"outcome_type":"secondary","measure":"Change From Baseline in Physical Activity (Light Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day","time_frame":"baseline, week 12","description":"Light intensity defined as less than three metabolic equivalents.\r\nMetabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.\r\nln in measure value unit means natural logarithm"},{"outcome_type":"secondary","measure":"Change From Baseline in Physical Activity (Light Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day","time_frame":"baseline, week 16","description":"Light intensity is less than three metabolic equivalents\r\nMetabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.\r\nln in measure value unit means natural logarithm"},{"outcome_type":"secondary","measure":"Change From Baseline in Physical Activity (Light Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day","time_frame":"baseline, week 20","description":"Light intensity is less than three metabolic equivalents\r\nMetabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.\r\nln in measure value unit means natural logarithm"},{"outcome_type":"secondary","measure":"Change From Baseline in Physical Activity (Light Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day","time_frame":"baseline, week 24","description":"Light intensity is less than three metabolic equivalents\r\nMetabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.\r\nln in measure value unit means natural logarithm"},{"outcome_type":"secondary","measure":"Physical Activity (Moderate or Higher Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day","time_frame":"baseline","description":"Moderate or higher intensity is greater than or equal to three metabolic equivalents\r\nMetabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.\r\nln in measure value unit means natural logarithm"},{"outcome_type":"secondary","measure":"Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day","time_frame":"baseline, week 4","description":"Moderate or higher intensity is greater than or equal to three metabolic equivalents\r\nMetabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.\r\nln in measure value unit means natural logarithm"},{"outcome_type":"secondary","measure":"Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day","time_frame":"baseline, week 8","description":"Moderate or higher intensity is greater than or equal to three metabolic equivalents\r\nMetabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.\r\nln in measure value unit means natural logarithm"},{"outcome_type":"secondary","measure":"Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day","time_frame":"baseline, week 12","description":"Moderate or higher intensity is greater than or equal to three metabolic equivalents\r\nMetabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.\r\nln in measure value unit means natural logarithm"},{"outcome_type":"secondary","measure":"Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day","time_frame":"baseline, week 16","description":"Moderate or higher intensity is greater than or equal to three metabolic equivalents\r\nMetabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.\r\nln in measure value unit means natural logarithm"},{"outcome_type":"secondary","measure":"Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day","time_frame":"baseline, week 20","description":"Moderate or higher intensity is greater than or equal to three metabolic equivalents\r\nMetabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.\r\nln in measure value unit means natural logarithm"},{"outcome_type":"secondary","measure":"Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day","time_frame":"baseline, week 24","description":"Moderate or higher intensity is greater than or equal to three metabolic equivalents\r\nMetabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.\r\nln in measure value unit means natural logarithm"},{"outcome_type":"secondary","measure":"Number of Participants With Healthy Lifestyle (Baseline)","time_frame":"baseline","description":"Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no"},{"outcome_type":"secondary","measure":"Number of Participants With Healthy Lifestyle (Week 4)","time_frame":"week 4","description":"Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no"},{"outcome_type":"secondary","measure":"Number of Participants With Healthy Lifestyle (Week 8)","time_frame":"week 8","description":"Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no"},{"outcome_type":"secondary","measure":"Number of Participants With Healthy Lifestyle (Week 12)","time_frame":"week 12","description":"Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no"},{"outcome_type":"secondary","measure":"Number of Participants With Healthy Lifestyle (Week 16)","time_frame":"week 16","description":"Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no"},{"outcome_type":"secondary","measure":"Number of Participants With Healthy Lifestyle (Week 20)","time_frame":"week 20","description":"Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no"},{"outcome_type":"secondary","measure":"Number of Participants With Healthy Lifestyle (Week 24)","time_frame":"week 24","description":"Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no"},{"outcome_type":"secondary","measure":"Active Energy Expenditure (Baseline)","time_frame":"baseline","description":"The amount of energy (kcal/day) that a person uses while physically active."},{"outcome_type":"secondary","measure":"Change From Baseline in Active Energy Expenditure (Week 4)","time_frame":"baseline, week 4","description":"The amount of energy (kcal/day) that a person uses while physically active."},{"outcome_type":"secondary","measure":"Change From Baseline in Active Energy Expenditure (Week 8)","time_frame":"baseline, week 8","description":"The amount of energy (kcal/day) that a person uses while physically active."},{"outcome_type":"secondary","measure":"Change From Baseline in Active Energy Expenditure (Week 12)","time_frame":"baseline, week 12","description":"The amount of energy (kcal/day) that a person uses while physically active."},{"outcome_type":"secondary","measure":"Change From Baseline in Active Energy Expenditure (Week 16)","time_frame":"baseline, week 16","description":"The amount of energy (kcal/day) that a person uses while physically active."},{"outcome_type":"secondary","measure":"Change From Baseline in Active Energy Expenditure (Week 20)","time_frame":"baseline, week 20","description":"The amount of energy (kcal/day) that a person uses while physically active."},{"outcome_type":"secondary","measure":"Change From Baseline in Active Energy Expenditure (Week 24)","time_frame":"baseline, week 24","description":"The amount of energy (kcal/day) that a person uses while physically active."},{"outcome_type":"secondary","measure":"Number of Steps Per Day (Baseline)","time_frame":"baseline","description":"Number of steps per day (baseline)"},{"outcome_type":"secondary","measure":"Change From Baseline in Number of Steps Per Day (Week 4)","time_frame":"baseline, week 4","description":"Change from baseline in number of steps per day (week 4)"},{"outcome_type":"secondary","measure":"Change From Baseline in Number of Steps Per Day(Week 8)","time_frame":"baseline, week 8","description":"Change from baseline in number of steps per day (week 8)"},{"outcome_type":"secondary","measure":"Change From Baseline in Number of Steps Per Day (Week 12)","time_frame":"baseline, week 12","description":"Change from baseline in Number of steps per day (week 12)"},{"outcome_type":"secondary","measure":"Change From Baseline in Number of Steps Per Day (Week 16)","time_frame":"baseline, week 16","description":"Change from baseline in number of steps per day (week 16)"},{"outcome_type":"secondary","measure":"Change From Baseline in Number of Steps Per Day (Week 20)","time_frame":"baseline, week 20","description":"Change from baseline in number of steps per day (week 20)"},{"outcome_type":"secondary","measure":"Change From Baseline in Number of Steps Per Day (Week 24)","time_frame":"baseline, week 24","description":"Change from baseline in number of steps per day (week 24)"}]}
{"nct_id":"NCT00446784","start_date":"2007-04-30","phase":"Phase 1","enrollment":20,"brief_title":"Study Of The Safety Of CE 224,545 And Methotrexate In Patients With Rheumatoid Arthritis","official_title":"A Phase 1, Double Blind Study Of The Safety And Pharmacokinetics Of Multiple Doses Of CE 224,535 In Subjects With Rheumatoid Arthritis Receiving Methotrexate","primary_completion_date":"2007-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-08-31","last_update":"2011-05-23","description":"CE 224,535 is being developed for the treatment of rheumatoid arthritis. The purpose of this study is to evaluate the safety and tolerability of CE 224,535 after 4 weeks of treatment in subjects with rheumatoid arthritis already receiving methotrexate","other_id":"A6341006","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adults patients with rheumatoid arthritis\r\n\r\n          -  Patients who have received stable weekly doses of oral methotrexate (5 to 25 mg/week\r\n             administered as a single dose) for a minimum of 28 days (4 weeks/4 doses)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of chronic infectious disease such as genitourinary, pulmonary or sinus\r\n             infections.\r\n\r\n          -  Any current or known malignancy or history of malignancy within the previous 5 years\r\n\r\n          -  Pregnant or lactating women; women of child-bearing potential who are unwilling to\r\n             unable to use an acceptable method of birth control during the study\r\n      ","sponsor":"Pfizer","sponsor_type":"Industry","conditions":"Arthritis, Rheumatoid","interventions":[{"intervention_type":"Drug","name":"Drug: CE-224,535"},{"intervention_type":"Drug","name":"Drug: Methotrexate"}],"outcomes":[{"outcome_type":"primary","measure":"Incidence and severity of adverse events throughout the study"},{"outcome_type":"secondary","measure":"Pharmacokinetics of CE 224,535 on Days 7 and 8"},{"outcome_type":"secondary","measure":"Pharmacokinetics of Methotrexate on Days 1 and 8"}]}
{"nct_id":"NCT00467220","start_date":"2007-04-30","phase":"N/A","enrollment":24,"brief_title":"Effect of Daily Calorie or Alternate-day Calorie Reductions on Risk for Cardiovascular Disease and Cancer","official_title":"Effect of Daily Calorie Restriction or Alternate-day Reductions in Calorie Intake on Risk for Cardiovascular Disease and Cancer","primary_completion_date":"2015-12-17","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-12-17","last_update":"2020-01-22","description":"The purpose of this study is to examine and compare the effects of alternate-day reductions in calorie intake or daily calorie restriction on the risk for cardiovascular disease and cancer.","other_id":"H3049-30095-01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":35,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male and female; body mass index (BMI) between 20-30 kg/m2;\r\n\r\n          -  Age between 35-65 years; sedentary (light exercise less than 1h per week) or\r\n             moderately active (1 to 2h per week);\r\n\r\n          -  Weight stable for >3 months prior to the beginning of the study;\r\n\r\n          -  Able to give written informed consent;\r\n\r\n          -  Female subjects must be post-menopausal for at least 2 years and can not be on hormone\r\n             replacement therapy (HRT).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Diabetic;\r\n\r\n          -  History of cardiovascular disease, i.e. myocardial infarction or stroke;\r\n\r\n          -  History of cancer;\r\n\r\n          -  Taking glucose lowering medication;\r\n\r\n          -  Taking weight loss medication\r\n      ","sponsor":"University of California, San Francisco","sponsor_type":"Other","conditions":"Moderately Overweight Individuals","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: calorie restriction","description":"Subjects in the \"calorie restriction\" arm and the \"alternate day fasting\" arm will be asked to follow a menu plan, for three months, that includes some level of calorie restriction."}],"outcomes":[{"outcome_type":"primary","measure":"Adipose tissue dynamics","time_frame":"12 weeks","description":"Parameters measured will include adipose tissue dynamics (triglyceride turnover, lipolysis, de novo lipogenesis, adipose cell proliferation), adipose tissue morphology (cell size and number), adipose tissue hormone levels (adiponectin, leptin), skin turnover (keratin dynamics), T-lymphocyte proliferation, as well as plasma lipid and lipoprotein, homocysteine, and C-reactive protein levels."}]}
{"nct_id":"NCT00403013","start_date":"2007-04-30","phase":"N/A","enrollment":64,"brief_title":"Plexus Anesthesia in Lateral, Head-Down Position for Elective Surgery of the Shoulder","official_title":"Axillary Plexus Block for Perioperative Analgesia in Patients Scheduled for Elective Surgery of the Shoulder: Influence of Lateral, Head-Down Position","primary_completion_date":"2008-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-06-30","last_update":"2009-07-07","description":"The purpose of this study is to determine whether the axillary plexus block performed in lateral, head down position is effective in the perioperative analgesia in patients scheduled for elective surgery of the shoulder.","other_id":"01-AnIt-06","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  patients scheduled for elective surgery of the shoulder\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  lateral, head down position not possible\r\n      ","sponsor":"University Hospital Muenster","sponsor_type":"Other","conditions":"Shoulder Surgery","interventions":[{"intervention_type":"Procedure","name":"Procedure: Positioning and anesthesia","description":"Positioning during axillary plexus block"}],"outcomes":[{"outcome_type":"primary","measure":"Visual Analog Scale (VAS) score","time_frame":"8 hours after start of axillary plexus block"},{"outcome_type":"primary","measure":"VAS Score","time_frame":"24 hours after start of axillary plexus block"},{"outcome_type":"secondary","measure":"Opioid consumption","time_frame":"intraoperatively"},{"outcome_type":"secondary","measure":"Patient comfort","time_frame":"six months after surgery"},{"outcome_type":"secondary","measure":"Opioid consumption","time_frame":"during hospital stay"}]}
{"nct_id":"NCT00447499","start_date":"2007-04-30","phase":"Phase 3","enrollment":59,"brief_title":"Assessment of the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel","official_title":"A Multi Center Open Label Study to Assess the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel","primary_completion_date":"2008-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-12-31","last_update":"2020-11-20","description":"The purpose of this study is to determine whether subjects with acromegaly (or their partners) are able to self administer Somatuline Autogel at home.","other_id":"MS315","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  The subject must give signed informed consent before any study-related activities.\r\n\r\n          -  The partner, if applicable, must give signed informed consent before administration of\r\n             Somatuline Autogel.\r\n\r\n          -  The subject must be able to understand the protocol requirements.\r\n\r\n          -  The subject must have a clinical diagnosis of acromegaly due to pituitary tumor.\r\n\r\n          -  The subject must be treated with a long-acting somatostatin analogue with or without a\r\n             dopamine agonist and have been on the current medical regimen for at least 3 months\r\n             prior to screening and have IGF-1 levels no higher than 10% above the upper limit of\r\n             the normal range for age and gender at the screening visit or be somatostatin analogue\r\n             nave (if the subject is treated with a dopamine agonist he/she must have been on the\r\n             current dose for at least 3 months prior to screening).\r\n\r\n          -  Subjects who are treated with a dopamine agonist have to stay on their current dose\r\n             for the duration of the study.\r\n\r\n          -  Switch subjects must have had their last pre-study routine clinical treatment with\r\n             Sandostatin LAR between 28 and 35 days before Visit 2 (enrollment).\r\n\r\n          -  The subject must be able to store the study medication in a refrigerator in his/her\r\n             own or his/her partner's home.\r\n\r\n          -  The subject must be 18 years of age.\r\n\r\n          -  Female subjects of childbearing potential must use adequate contraception.\r\n\r\n          -  Female subjects of childbearing potential who are taking oral contraceptives must\r\n             agree to stay on their current contraceptive dose for the duration of the study.\r\n\r\n          -  The partner, if applicable, must be 18 years of age.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  The subject has had pituitary surgery (adenomectomy) within 3 months prior to\r\n             screening.\r\n\r\n          -  The subject has received pituitary radiotherapy within 3 years prior to screening.\r\n\r\n          -  The subject has received a GH receptor antagonist within 6 months prior to screening.\r\n\r\n          -  The subject is currently on a higher dose of Sandostatin LAR than 30mg q28d\r\n\r\n          -  The subject is pregnant or breastfeeding.\r\n\r\n          -  The subject has clinically significant renal or hepatic abnormalities.\r\n\r\n          -  The subject has a symptomatic, untreated biliary lithiasis.\r\n\r\n          -  The subject has uncontrolled diabetes or thyroid disease.\r\n\r\n          -  The subject has a known hypersensitivity to any of the test materials or related\r\n             compounds.\r\n\r\n          -  The subject is unable or unwilling to comply with the protocol.\r\n\r\n          -  The subject has received any investigational drug within 30 days prior to screening.\r\n\r\n          -  The subject has participated in a medical device study within 30 days prior to\r\n             screening.\r\n\r\n          -  The subject has previously participated in this study.\r\n      ","sponsor":"Ipsen","sponsor_type":"Industry","conditions":"Acromegaly","interventions":[{"intervention_type":"Drug","name":"Drug: Somatuline Autogel (lanreotide acetate)","description":"Injections"},{"intervention_type":"Behavioral","name":"Behavioral: Home administration","description":"Questionnaire"}],"outcomes":[{"outcome_type":"primary","measure":"The Percentage of Subjects or Their Partners That Are Competent to Self-administer Somatuline Autogel at the End of the Study, (Week 24/Early Termination), as Assessed by the Competence Questionnaire Score.","time_frame":"24 weeks","description":"The primary efficacy endpoint was the percentage of patients (Switch and other) or their partners who were competent to self-administer lanreotide at the end of the study (Week 24/Early Termination), as assessed by the Assessment of Competence Questionnaire (0 = 'No' and 1 = 'Yes')."},{"outcome_type":"secondary","measure":"Percentage of Switch Subjects Who Find Self-administration of Somatuline Autogel Convenient as Assessed by the Subject Convenience Questionnaire Score.","time_frame":"24 weeks","description":"Experienced Convenience of Somatuline® Autogel® Injections was assessed by the subject as: Very convenient; somewhat convenient; neither convenient nor inconvenient; Neither convenient nor inconvenient; Somewhat inconvenient; very inconvenient."},{"outcome_type":"secondary","measure":"Percentage of Switch Subjects That Have IGF-1 Levels Within the Normal Range for Age and Gender at the End of the Study","time_frame":"24 weeks","description":"Blood sample was collected while subject is in a fasting state or non-fasting state for measuring the level of IGF-1."},{"outcome_type":"secondary","measure":"Percentage of Switch Subjects That Have Glucose Suppressed GH Levels ≤ 2.5 ng/ml at the End of the Study, Week 24/Termination.","time_frame":"24 Weeks","description":"Blood samples taken before and 60 and 120 min after glucose load from fasting patient."},{"outcome_type":"secondary","measure":"Change of GH Concentration Levels From Basaeline to Week 24 in Switch Patients","time_frame":"24 Weeks","description":"Blood samples taken before and 60 and 120 min after glucose load from fasting patient."},{"outcome_type":"secondary","measure":"Total Symptom Questionnaire Score at Week 24/Termination","time_frame":"24 Weeks","description":"Acromegaly symptoms are sweating, snoring, joint pain, headache and fatigue. Each symptom was scored as -2 = 'always', -1 = 'most of the time', 0 = 'sometimes', 1 = 'rarely and 2 = 'never'. The total score was used to evaluate symptom control in each patient at Week 0 and Week 24/Termination. The total worst score is -10 and best score is 10."},{"outcome_type":"secondary","measure":"Total Health Care Professional Convenience Questionnaire Score at Week 24/Termination","time_frame":"24 weeks","description":"Healthcare professional convenience questionnaires are: Confident the Subject Properly Administering the Injection; Subject Complained About Pain When Administering the Injection; Subject Appreciated the Option of Self-Injection at Home. Each Healthcare professional convenience questionnaire was scored -2, -1, 0, 1 and 2; from most negative to most positive response. A total score across all questions was calculated and was used to evaluate the convenience. The worst total score is -6 and best total score is 6."}]}
{"nct_id":"NCT00456560","start_date":"2007-04-30","phase":"Phase 1","enrollment":30,"brief_title":"AV650 Drug-Drug Interaction Study","official_title":"A Phase I, Randomized, Two-Period, Single-Center Study to Assess the Effect of CYP2D6 and CYP2C19 Inhibitors on a Single Oral Dose of AV650 (300 mg) in Healthy Subjects","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-05-31","last_update":"2007-09-17","description":"The purpose of this study is to evaluate the effects that paroxetine and fluvoxamine have on the way the body distributes, breakdowns and eliminates AV650. In addition, information about any side effects that may occur will also be collected.","other_id":"AV650-019","allocation":"Randomized","intervention_model":"Parallel Assignment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  BMI between 18.5 to 29.9 kg/m2\r\n\r\n          -  In good health, determined by no clinically significant findings from medical history,\r\n             12-lead ECG, and vital signs\r\n\r\n          -  Clinical laboratory evaluations within the reference range for the test laboratory\r\n\r\n          -  Negative test for selected drugs of abuse at Screening\r\n\r\n          -  Negative HBsAg and HIV antibody screens\r\n\r\n          -  Females of childbearing potential must be surgically sterile, post-menopausal for at\r\n             least one year, or using and effective method of contraception; females of child\r\n             bearing potential must have a negative serum pregnancy test at Screening and Day -1\r\n\r\n          -  Males must be either sterile or agree to use an approved method of contraception\r\n\r\n          -  Able to comprehend and willing to sign an Informed Consent Form\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History or clinical manifestations of significant metabolic, hepatic, renal,\r\n             hematological, pulmonary, cardiovascular, endocrine, gastrointestinal, urological,\r\n             neurological, psychiatric disorders, or cancer\r\n\r\n          -  History of inflammatory arthritis\r\n\r\n          -  History of symptomatic hypotension\r\n\r\n          -  History of severe physical injury, direct impact trauma, or neurological trauma within\r\n             6 months\r\n\r\n          -  History of seizure disorders\r\n\r\n          -  History of bipolar or major depressive disorder\r\n\r\n          -  History of hypersensitivity or allergies to any drug compound\r\n\r\n          -  Known intolerance to benzodiazepines\r\n\r\n          -  Known intolerance to active and/or inactive ingredients in fluvoxamine or paroxetine\r\n\r\n          -  History of stomach or intestinal surgery or resection, except that appendectomy,\r\n             hernia repair, and/or cholecystectomy will be allowed\r\n\r\n          -  History or presence of an abnormal ECG\r\n\r\n          -  History of alcoholism, drug abuse, or drug addiction\r\n\r\n          -  Use of any nicotine-containing or nicotine-replacement products within 6 months of Day\r\n             -1\r\n\r\n          -  Participation in any other investigational study drug trial within 90 days of Day -1\r\n\r\n          -  Use of any prescription medications/products within 3 months of Day 1 unless deemed\r\n             acceptable by the PI\r\n\r\n          -  Received any vaccination or immunization within 1 month of Day -1\r\n\r\n          -  Use of any over-the-counter, non-prescription preparations within 7 days of Day -1\r\n\r\n          -  Use of alcohol-containing, grapefruit-containing, or caffeine-containing foods or\r\n             beverages with 72 hours of Day -1\r\n\r\n          -  Poor peripheral venous access\r\n\r\n          -  Donation of blood within 3 months of Day -1 or of plasma within 2 weeks of Screening\r\n\r\n          -  Receipt of blood products within 2 months of Day 1\r\n\r\n          -  Female subjects who are pregnant or nursing\r\n\r\n          -  Any acute or chronic condition that, in the opinion of the PI, would limit the\r\n             subject's ability to complete and/or participate in this clinical study\r\n      ","sponsor":"Avigen","sponsor_type":"Industry","conditions":"Healthy","interventions":[{"intervention_type":"Drug","name":"Drug: AV650"},{"intervention_type":"Drug","name":"Drug: Fluvoxamine"},{"intervention_type":"Drug","name":"Drug: Paroxetine"}],"outcomes":[{"outcome_type":"primary","measure":"Pharmacokinetics of AV650"},{"outcome_type":"secondary","measure":"Safety and tolerability of AV650"},{"outcome_type":"secondary","measure":"Genetic contribution, if any, to AV650 metabolism"}]}
{"nct_id":"NCT00598299","start_date":"2007-04-30","enrollment":100,"brief_title":"Comparison of the Effects on Promoting Corneal Epithelial Wound Healing Between Human Auto-Serum and Cord Blood Serum","official_title":"Department of Ophthalmology, National Taiwan University Hospital","study_type":"Observational","rec_status":"Completed","completion_date":"2008-04-30","last_update":"2008-11-04","description":"Human serum eye drops have been successfully used in the treatment of severe ocular surface disorders and the enhancement of corneal wound healing. Umbilical cord serum is also proven to be effective in treatment of dry eye and persistent corneal epithelial defects. However, there are limited studies comparing the corneal epithelial wound healing promoting effects between these two blood derived products. The purpose of this study is to test the corneal epithelial wound healing promoting effects between auto serum and human cord blood serum. Primary cultured bovine corneal epithelial cells were used as the model to investigate wound healing, cell proliferation and migration by means of scratch corneal wound healing assay evaluation, MTS assay and Boyden chamber migration assay in response to human serum and umbilical cord serum. The concentrations of EGF, TGF-1, and fibronectin were also compared between human serum and umbilical cord serum with ELISA kits.","other_id":"20072037R","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":60,"population":"heahty adult volunteers and donated cord blood","criteria":"\n        Inclusion Criteria:\r\n\r\n        healthy volunteers\r\n\r\n        Exclusion Criteria:\r\n\r\n        unhealthy volunteers\r\n      ","sponsor":"National Taiwan University Hospital","sponsor_type":"Other","conditions":"Eye Injuries","interventions":[{"intervention_type":"Procedure","name":"Procedure: venous puncture","description":"venous puncture"},{"intervention_type":"Other","name":"Other: obtain serum from perripheral blood or cord blood","description":"obtain serum from perripheral blood or cord blood"}],"outcomes":{}}
{"nct_id":"NCT00539942","start_date":"2007-04-30","phase":"Phase 3","enrollment":7,"brief_title":"Study of Arixtra (Fondaparinux Sodium) to Prevent Blood Clots in Women Undergoing Abdominopelvic Surgery for Likely Gynecologic Malignancy","official_title":"Extended Deep Venous Thrombosis Prophylaxis in Gynecologic Oncology Surgery With Intermittent Compression Devices (ICD) With or Without Postoperative Arixtra (Fondaparinux Sodium): A Randomized Controlled Trial","primary_completion_date":"2010-06-30","study_type":"Interventional","rec_status":"Terminated","completion_date":"2010-06-30","last_update":"2017-03-27","description":"This is a randomized trial to compare intermittent compression devices with or without post-operative Arixtra (fondaparinux sodium) in women undergoing major abdominal surgery for known or presumed gynecologic malignancies. This trial seeks to determine if there is a difference in the rate of deep venous thrombosis between these two groups.","other_id":"F070727009","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":19,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  All patients undergoing open laparotomy (non-laparoscopic) gynecologic surgery.\r\n\r\n          -  Patients must be competent to self-administer injections, or must have caregivers or\r\n             nurses who can perform injections\r\n\r\n          -  Patients must have signed an approved informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with medical history which requires chronic anticoagulation (i.e. previous\r\n             DVT, pulmonary embolism, atrial fibrillation, heart valve replacement)\r\n\r\n          -  Patients with contraindications to anticoagulation (generalized bleeding disorders,\r\n             peptic ulcer disease, hemorrhagic stroke, etc)\r\n\r\n          -  Contraindications to placement of ICDs (history of lower extremity venous stasis\r\n             ulcers)\r\n\r\n          -  Patients receiving low molecular weight heparin or unfractionated heparin for\r\n             prophylaxis post-operatively\r\n\r\n          -  Patients who are unable to receive injections as an outpatient and/or unable to\r\n             undergo a doppler ultrasound of the lower extremities\r\n\r\n          -  Renal insufficiency (creatinine clearance < 30 mL/min)\r\n\r\n          -  Patients who have a body weight < 50 kg\r\n\r\n          -  Hypersensitivity to low molecular weight heparin\r\n\r\n          -  Patients who are pregnant or have a positive pregnancy test.\r\n\r\n          -  Patients receiving continuous (indwelling) epidural.\r\n      ","sponsor":"University of Alabama at Birmingham","sponsor_type":"Other","conditions":"Venous Thrombosis","interventions":[{"intervention_type":"Drug","name":"Drug: Arixtra (fondaparinux sodium)","description":"Treatment will consist of daily injections of pharmacy prepared syringes of Arixtra (fondaparinux sodium) 2.5mg. Treatment will continue for 21 consecutive days to end on post-operative day 22."},{"intervention_type":"Device","name":"Device: Intermittent compression devices (ICD)","description":"All patients will receive intermittent compression devices (ICD's) during the patient's entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial."}],"outcomes":[{"outcome_type":"secondary","measure":"Incidence of Untoward Effects With Arixtra","time_frame":"21 days","description":"Adverse events will be evaluated to determine untoward effects."},{"outcome_type":"primary","measure":"Comparison of Deep Venous Thromboembolism (DVT) Using Intermittent Compression Devices With and Without Arixtra","time_frame":"21 days","description":"Deep venous thromboembolism (DVT) rates are determined from lower extremity doppler ultrasound measurements."}]}
{"nct_id":"NCT01097161","start_date":"2007-04-30","phase":"N/A","enrollment":4,"brief_title":"Stuttering and Apraxia of Speech: the Efficacy of an Intervention Program","official_title":"The Speech Prosody of People With Stuttering and Developmental Apraxia: the Efficacy of an Intervention Program","primary_completion_date":"2007-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-06-30","last_update":"2010-04-02","description":"Subjects' utterances were submitted to acoustic analysis before and after the intervention program applied on prosodic basis.","other_id":"SHA 0097/06","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Clinical diagnosis of stuttering\r\n\r\n          -  Clinical diagnosis of apraxia of speech\r\n\r\n          -  18 years of age or older\r\n\r\n          -  Portuguese native language\r\n\r\n          -  Agreement by the participant to enroll on 20 therapy sessions scheduled in a 3 month\r\n             period\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of major medical illness unrelated to primary diagnosis of developmental\r\n             stuttering and developmental apraxia of speech\r\n\r\n          -  Significant abnormalities on general physical and neurological examination unrelated\r\n             to primary diagnosis\r\n      ","sponsor":"Federal University of Minas Gerais","sponsor_type":"Other","conditions":"Stuttering|Developmental Apraxia of Speech","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: speech therapy with the assistance of an acoustical analysis program","description":"Two weekly speech sessions realized on individual basis for three months period"}],"outcomes":{}}
{"nct_id":"NCT00955747","start_date":"2007-04-30","phase":"Phase 3","enrollment":494,"brief_title":"Naturlose (D-Tagatose) Efficacy Evaluation Trial","official_title":"Effects of Naturlose (Tagatose) on Glycemic Control and Safety of Naturlose Over One Year in Subjects With Type 2 Diabetes Under Diet Control and Exercise","primary_completion_date":"2010-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-10-31","last_update":"2014-11-19","description":"The purpose of this trial was to evaluate the effectiveness and safety of Naturlose (Tagatose) for glycemic control in people with Type 2 diabetes who were not taking other medications for the condition and who were under diet control and exercise. The study lasted approximately one year. HbA1c was monitored every 2 months after entry into the study. Safety and tolerance for tagatose were assessed every 2 months throughout the study. A total of 14 visits were made to the study site.","other_id":"70971-004","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Type 2 diabetics in accordance with WHO.\r\n\r\n          -  Male and female patients, between 18 and 75 years of age.\r\n\r\n          -  Diabetic patients who are not on medication for the disease. Patients may be treated\r\n             with diet and exercise.\r\n\r\n          -  Normal blood creatine clearance and normal liver function test results.\r\n\r\n          -  BMI less than or equal to 45kg/m2.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Treatment with sulfonylurea (e.g., Glyburide, Glipizide, Glimepiride, Chlorpropamide,\r\n             Tolazamide, Acetohexamide, or Tolbutamide), TZDs, metformin, acarbose, Byetta,\r\n             insulin, and any antidiabetic medications within the prior 3 months.\r\n\r\n          -  Therapy with beta-blockers or thiazide diuretics within the prior 3 months.\r\n\r\n          -  Pregnancy, breastfeeding, or intention of becoming pregnant or judged to be using\r\n             inadequate contraceptive measure.\r\n\r\n          -  Documented gastrointestinal disease, or taking of medications likely to alter gut\r\n             motility or absorption.\r\n\r\n          -  Receiving any investigational drug within 30 days of the baseline visit.\r\n      ","sponsor":"Robert Lodder","sponsor_type":"Industry","conditions":"Type 2 Diabetes","interventions":[{"intervention_type":"Drug","name":"Drug: Tagatose","description":"powder; 15 grams three times daily; one year"},{"intervention_type":"Drug","name":"Drug: Sugar Substitute Splenda","description":"1.5 g powder tid"}],"outcomes":[{"outcome_type":"primary","measure":"Change in Hemoglobin A1C Level From Baseline","time_frame":"1 year from baseline","description":"The primary efficacy variable will be the change in HbA1c level from baseline. Changes from baseline in HbA1c level at each visit will be assessed with the use of linear model(ANCOVA) to adjust for any baseline difference, as well as the stratification factor."}]}
{"nct_id":"NCT00460538","start_date":"2007-04-30","phase":"Phase 4","enrollment":48,"brief_title":"Efficacy and Safety of Lectranal in Treatment of Seasonal Allergic Rhinitis Symptoms","official_title":"Efficacy and Safety of Lectranal in Treatment of Seasonal Allergic Rhinitis Symptoms","primary_completion_date":"2007-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-11-30","last_update":"2010-04-05","description":"The purpose of the study is to determine weather Lectranal is effective in treatment of seasonal allergic rhinitis symptoms.","other_id":"MIL-002","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  history of seasonal allergic rhinitis symptoms to pollen\r\n\r\n          -  positive skin prick test to pollen\r\n\r\n          -  negative history of seasonal allergic asthma\r\n\r\n          -  male or female older than 18\r\n\r\n          -  female participants must use appropriate contraception\r\n\r\n          -  able to comply to study procedures\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  pregnancy\r\n\r\n          -  alcohol or drug abuse\r\n\r\n          -  subject receiving antihistamines , immunotherapy or on hyposensibilisation\r\n      ","sponsor":"Milsing d.o.o.","sponsor_type":"Other","conditions":"Seasonal Allergic Rhinitis","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Lectranal","description":"Dosage form: capsule\r\n1: Dosage: 2 capsule Frequency and duration: 2 times daily over the 6 weeks"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: placebo","description":"Dosage form: capsule 2: Dosage: 2 capsules Frequency and duration: 2 times daily over the 6 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"changes in SARS (seasonal allergic rhinitis symptoms)","time_frame":"6 weeks"},{"outcome_type":"primary","measure":"changes in Mini RQLQ (mini rhinoconjunctivitis quality of life questionnaire)","time_frame":"6 weeks"},{"outcome_type":"primary","measure":"changes in specific IgE","time_frame":"6 weeks"},{"outcome_type":"primary","measure":"changes in specific IgG","time_frame":"6 weeks"},{"outcome_type":"secondary","measure":"Prick test change","time_frame":"6 weeks"},{"outcome_type":"secondary","measure":"change in eosinophilia in nasal secretion","time_frame":"6 weeks"}]}
{"nct_id":"NCT00472290","start_date":"2007-04-01","phase":"N/A","enrollment":72,"brief_title":"Evaluating the Safety of Long Term Dosing of Romiplostim (Formerly AMG 531) in Thrombocytopenic Subjects With Myelodysplastic Syndromes (MDS)","official_title":"An Open Label Extension Study Evaluating the Safety of Long Term Dosing of Romiplostim in Thrombocytopenic Subjects With Myelodysplastic Syndromes (MDS)","primary_completion_date":"2011-07-18","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-12-26","last_update":"2017-12-29","description":"This is an open label extension study of romiplostim for treatment of thrombocytopenia (platelet count  50 x 10^9/L) in MDS subjects. The study is designed to assess the long-term safety of treatment with romiplostim, as measured by incidence of overall adverse events, the incidence of bleeding events, the utilization of platelet transfusions, and the duration of platelet response. The study will further describe the time to disease progression to acute myeloid leukemia (AML) and survival.","other_id":"20060197","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria\r\n\r\n          -  Subject completed a romiplostim study for the treatment of thrombocytopenia in\r\n             subjects with MDS\r\n\r\n          -  Subject has an Eastern Cooperative Oncology (ECOG) performance status of 0 to 2\r\n\r\n          -  Subject had a platelet count  50 x 10^9/L since the final dose of investigational\r\n             product in the parent study\r\n\r\n          -  Subject or his/her legally acceptable representative provided written informed consent\r\n             before any study-specific procedures were initiated\r\n\r\n        Exclusion Criteria\r\n\r\n          -  Subject has been diagnosed with AML or has a blast count  10% by peripheral blood or\r\n             bone marrow biopsy\r\n\r\n          -  Subject has a prior history of leukemia\r\n\r\n          -  Subject has a prior history of bone marrow or stem cell transplantation\r\n\r\n          -  Subject has a prior malignancy (other than in situ cervical cancer, controlled\r\n             prostate cancer, or basal cell cancer of the skin) unless treated with curative intent\r\n             and without evidence of disease for  3 years before randomization\r\n\r\n          -  Subject has active or uncontrolled infections\r\n\r\n          -  Subject has unstable angina, congestive heart failure [New York Heart Association\r\n             (NYHA) > class II], uncontrolled hypertension (diastolic > 100 mmHg), uncontrolled\r\n             cardiac arrhythmia, or recent (within 1 year) myocardial infarction\r\n\r\n          -  Subject has a history of arterial thrombosis (eg, stroke or transient ischemic attack)\r\n             in the past year\r\n\r\n          -  Subject has a history of venous thrombosis that currently requires anti-coagulation\r\n             therapy\r\n\r\n          -  Subject received interleukin (IL)-11 within 4 weeks of screening\r\n\r\n          -  Subject previously received a thrombopoietic growth factor (other than romiplostim)\r\n\r\n          -  Subject has a known hypersensitivity to any recombinant E coli-derived product (eg,\r\n             Infergen, Neupogen, Somatropin, Actimmune)\r\n\r\n          -  Subject is currently enrolled in investigational device or drug study(ies), has not\r\n             yet completed at least 4 weeks since ending investigational device or drug study(ies)\r\n             (other than parent romiplostim study), or subject is receiving other investigational\r\n             agent(s)/device(s)\r\n\r\n          -  Subject is of child-bearing potential and is evidently pregnant (eg, positive human\r\n             chorionic gonadotropin [HCG] test) or is breast feeding\r\n\r\n          -  Subject is not using adequate contraceptive precautions\r\n\r\n          -  Subject has any kind of disorder that compromises his/her ability to give written\r\n             informed consent (and does not have a legally acceptable representative) or is unable\r\n             to comply with study procedures\r\n      ","sponsor":"Amgen","sponsor_type":"Industry","conditions":"Hematology|MDS|Myelodysplastic Syndromes|Thrombocytopenia","interventions":[{"intervention_type":"Drug","name":"Drug: Romiplostim (formerly AMG 531)","description":"Subjects will begin the study at an initial dose of 750 g.\r\nExcept for:\r\nSubject whose doses were escalated to doses higher than 750 g AMG 531 weekly, and maintained a response per IWG guidelines for platelet response.\r\nSubjects who were stable at a lower dose of AMG 531 on the previous study. Doses will be adjusted throughout the study based on individual subject's platelet count."}],"outcomes":[{"outcome_type":"primary","measure":"Overall Summary of Adverse Events","time_frame":"During treatment period from first dose of IP to End of Study visit, on Average 56 Weeks ."},{"outcome_type":"primary","measure":"Incidence of Antibody (AB) Formation","time_frame":"During treatment period from first dose of IP to End of Study visit, on Average 56 Weeks."},{"outcome_type":"secondary","measure":"Weekly Bleeding Events Per 100 Subject Years","time_frame":"During the treatment period. The average duration of romiplostim exposure is 56 weeks.","description":"During the time since the first dose of IP to the end of the treatment period. A single bleeding event was defined as each individual bleeding episode that originated from a specific organ system (eg, gastrointestinal system or central nervous system). A bleeding event that continued for more than 7 days was counted as separate events every eighth day."},{"outcome_type":"secondary","measure":"Platelet Transfusion Events Per 100 Subject Years","time_frame":"During the treatment period. The average duration of romiplostim exposure is 56 weeks.","description":"During the time since the first dose of IP to the end of the treatment period. A discrete platelet transfusion event was defined as any number of platelet transfusions administered within a 3-day period. Platelet transfusions administered more than 3 days apart were counted as separate platelet transfusion events."},{"outcome_type":"secondary","measure":"Weeks With Platelet Response Per Year","time_frame":"During the treatment period. The average duration of romiplostim exposure is 56 weeks.","description":"During the time since the first dose of IP to the end of the treatment period. Platelet response was based on the modified IWG 2006 criteria (Cheson et al, 2006) and was defined as, in the absence of platelet transfusion: an absolute increase in platelet count of ≥ 30 x 10^9/L for a subject starting with a platelet count of ≥ 20 x 10^9/L; or an increase in platelet count from < 20 x 10^9/L to ≥ 20 x 10^9/L and by at least 100% in a subject that started with a platelet count < 20 x 10^9/L."},{"outcome_type":"secondary","measure":"Time to First Platelet Response","time_frame":"During treatment period. The average duration of romiplostim exposure is 56 weeks.","description":"Time since first dose of IP to the first platelet response. Platelet response was based on the modified IWG 2006 criteria (Cheson et al, 2006) and was defined as, in the absence of platelet transfusion: an absolute increase in platelet count of ≥ 30 x 10^9/L for a subject starting with a platelet count of ≥ 20 x 10^9/L; or an increase in platelet count from < 20 x 10^9/L to ≥ 20 x 10^9/L and by at least 100% in a subject that started with a platelet count < 20 x 10^9/L."},{"outcome_type":"secondary","measure":"Duration of Platelet Response","time_frame":"During treatment period. The average duration of romiplostim exposure is 56 weeks.","description":"Platelet response was based on the modified IWG 2006 criteria (Cheson et al, 2006) and was defined as, in the absence of platelet transfusion: an absolute increase in platelet count of ≥ 30 x 10^9/L for a subject starting with a platelet count of ≥ 20 x 10^9/L; or an increase in platelet count from < 20 x 10^9/L to ≥ 20 x 10^9/L and by at least 100% in a subject that started with a platelet count < 20 x 10^9/L."}]}
{"nct_id":"NCT00458081","start_date":"2007-03-31","phase":"Phase 3","enrollment":174,"brief_title":"Evaluation of the Rimonabant Impact on the Regression of Asymptomatic Damage Caused by Cardiovascular Risk Factors","official_title":"A 12-month Multicentre, Randomised, Double-blind, Placebo-controlled Study With Two Parallel Groups to Assess the Effects of Rimonabant 20 mg in Patients With Abdominal Obesity and Microalbuminuria, With Type 2 Diabetes Mellitus or Dyslipidaemia With or Without Other Cardiometabolic Risk Factors.","primary_completion_date":"2009-01-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2009-01-31","last_update":"2010-12-10","description":"Primary objective: - To assess the effect on microalbuminuria levels of treatment with rimonabant 20 mg versus a placebo during a 12 month period. Secondary objectives: - Percentage of patients in both arms of the study whose levels of microalbuminuria decrease, stabilise, increase towards macroalbuminuria or are unchanged after 12 months of treatment with rimonabant or placebo. - To assess the effect of treatment with rimonabant 20 mg versus placebo over a 12 month period on: - Weight and waist circumference. - Glycaemia profile: fasting glycaemia, fasting insulinaemia and HbA1c. - Lipid and lipoprotein profile: triglycerides, total cholesterol, HDL-C, LDL-C, apolipoproteins A1 and B. - Inflammatory markers - Adipocytokines. - Blood pressure. - Glomerular filtration rate. - To assess the quality of life by means of questionnaire filled in. - Safety parameters","other_id":"RIMON_L_01031","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":30,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Body Mass Index > 27 kg/m2 and < 40 kg/m2.\r\n\r\n          -  Waist circumference > 102 cm in men and > 88 cm in women.\r\n\r\n          -  Microalbuminuria >= 20 mg/g creatinine and < 300 mg/g creatinine in at least two of\r\n             three morning urine samples taken on 3 separate days prior to the baseline visit.\r\n\r\n          -  Type 2 diabetes and/or dyslipidaemia.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Breastfeeding or pregnant women or who expect to become pregnant.\r\n\r\n          -  Non-use of approved methods of contraception in women of child-bearing potential.\r\n\r\n          -  History of very low calorie diet in the 3 months prior to the screening visit (<1200\r\n             kcal/day).\r\n\r\n          -  Change in weight > 5 kg in the 3 months prior to the screening visit.\r\n\r\n          -  History of surgery for weight loss (such as vertical banded gastroplasty, gastric\r\n             by-pass, etc.)\r\n\r\n          -  History of bulimia or anorexia nervosa according to DSM-IV definition.\r\n\r\n          -  Any clinically significant endocrine disorder, in the opinion of the investigator,\r\n             especially known alterations in the blood concentration of TSH and free T4.\r\n\r\n          -  Type 1 Diabetes\r\n\r\n          -  Triglyceridaemia > 400 mg/dl (4.52 mmol/l)\r\n\r\n          -  Severe renal dysfunction\r\n\r\n          -  Chronic Hepatitis or clinically known significant liver disease or ALT and/or AST > 3x\r\n             the upper limit of the normal range at the screening visit.\r\n\r\n          -  Hypertension at the screening visit.\r\n\r\n          -  Presence of any condition (medical, including clinically significant abnormal\r\n             laboratory tests, physiological, social or geographical) actual or anticipated that\r\n             the investigator feels would compromise the patient's safety or limit his/her\r\n             successful participation to the study.\r\n\r\n          -  History of abuse of alcohol or other substances (except smoking).\r\n\r\n          -  Hypersensitivity or intolerance to the active ingredient or any of the excipients,\r\n             such as lactose.\r\n\r\n        Concomitant medication prior to the screening visit\r\n\r\n          -  Administration of any treatment undergoing clinical investigation (drug or medical\r\n             device) in the 30 days prior to the screening visit.\r\n\r\n          -  Previous treatment with rimonabant.\r\n\r\n          -  Administration of any of the following products in the 3 months prior to the screening\r\n             visit\r\n\r\n               -  Anti-obesity drugs (such as, sibutramine or orlistat).\r\n\r\n               -  Other weight loss drugs (phentermine,amphetamines).\r\n\r\n               -  Weight loss herbal preparations.\r\n\r\n               -  Nicotinic acid, fibrates, bile acid sequestrants or Omega 3 drugs (e.g. Omacor).\r\n\r\n               -  Prolonged use (more than a week) of systemic corticosteroids or neuroleptics\r\n\r\n               -  Antidepressants (including bupropion)\r\n\r\n               -  Insulin, thiazolidinediones, -glucosidase inhibitors, meglitinides or any group\r\n                  of antidiabetic drugs (except combination of biguanides and sulfonylureas)\r\n\r\n          -  In type 2 diabetes patients, start of or change in treatment with sulfonylureas and/or\r\n             metformin, in the 4 weeks prior to the screening visit.\r\n\r\n          -  Start of or change in treatment with antihypertensive drugs in the 12 weeks prior to\r\n             the screening visit.\r\n\r\n          -  Start of or change in treatment with statins and/or ezetimibe in the 8 weeks prior to\r\n             the screening visit.\r\n\r\n        The above information is not intended to contain all considerations relevant to a patient's\r\n        potential participation in a clinical trial.\r\n      ","sponsor":"Sanofi","sponsor_type":"Industry","conditions":"Obesity|Microalbuminuria|Diabetes Mellitus, Type 2|Dyslipidemia","interventions":[{"intervention_type":"Drug","name":"Drug: Rimonabant","description":"20 mg once per day + slightly reduced calorie diet"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"placebo once per day + slightly reduced calorie diet"}],"outcomes":[{"outcome_type":"primary","measure":"Relative change in the microalbuminuria level.","time_frame":"between baseline visit and Month 12"},{"outcome_type":"secondary","measure":"Percentage of patients whose albuminuria levels decrease, stabilise, are progressing towards macroalbuminuria, are unaltered.","time_frame":"between baseline visit and Month 12"},{"outcome_type":"secondary","measure":"Relative change and absolute change of Weight, Waist circumference, Body mass index (weight and height), Specific lipid parameters, Glycaemia control parameters, Proinflammatory markers, Adipocytokines, Glomerular filtration rate, Blood pressure","time_frame":"between baseline visit and Month 12"},{"outcome_type":"secondary","measure":"Evaluation of the Quality of Life (questionnaire IWQOL).","time_frame":"at baseline visit and at 3, 6 and 12 months visit"},{"outcome_type":"secondary","measure":"Safety (including neuropsychiatric events) and Laboratory assessments.","time_frame":"at each visit and at baseline, 3, 6 and 12 month visits"}]}
{"nct_id":"NCT00693628","start_date":"2007-03-31","phase":"N/A","enrollment":4,"brief_title":"Effects of Shrinker Use on Healing and Volume","official_title":"Effects of Shrinker Use on Healing and Volume for Transtibial Amputees","primary_completion_date":"2012-01-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2012-01-31","last_update":"2017-06-05","description":"We expect subjects in the interventional groups, who wear shrinkers, to heal more quickly than control subjects who wear no shrinkers. We also expect them to experience greater reduction in residual limb volume during the early stages of postoperative care leading up to prosthetic fitting, fewer healing complications, reduced time to the prosthetic fitting, increased time to the first prosthetic socket replacement, and fewer socket replacements by the end of the \"transition to stable phase\".","other_id":"13310","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Recently undergone primary transtibial amputation\r\n\r\n          -  Patients between ages of 18 and 100 years of age\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Undergone previous amputations above the Symes level\r\n      ","sponsor":"University of Oklahoma","sponsor_type":"Other","conditions":"Transtibial Amputation","interventions":[{"intervention_type":"Device","name":"Device: compression shrinker","description":"Two levels of compression: 20-30 mmHg or 30-40 mmHg shrinker"}],"outcomes":[{"outcome_type":"primary","measure":"Reduction in Time to Healing","time_frame":"1 year","description":"time to healing in each group"}]}
{"nct_id":"NCT01800812","start_date":"2007-03-31","phase":"Phase 1","enrollment":27,"brief_title":"Effects of OM-174 in Adult Patients With Solid Tumors","official_title":"Phase One Study With Direct Individual Benefit: Effects of OM-174 in Adult Patients With Solid Tumors.","primary_completion_date":"2008-01-31","study_type":"Interventional","rec_status":"Completed","last_update":"2013-02-28","description":"Methods Patients received OM-174 twice weekly for a total of 5, 10 or 15 injections of either 600, 800 or 1000 g/m. Pharmacokinetic analysis and cytokine dosages were performed. Natural Killer cells activity and toll-like receptors 4 polymorphism analysis were also performed.","other_id":"BARDOU PHRC R 2002","allocation":"Non-Randomized","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patient with a histologically proven solid tumor, refractory to conventional treatment\r\n             or for which no such treatment existed.\r\n\r\n          -  At least one month since the last chemotherapy\r\n\r\n          -  Life expectancy above 3 months\r\n\r\n          -  Written informed consent\r\n\r\n          -  Age above 18\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patient's refusal\r\n\r\n          -  Infection\r\n\r\n          -  Brain metastasis\r\n\r\n          -  Autoimmune disease\r\n\r\n          -  Regular use of steroids\r\n\r\n          -  Patient included in another protocol\r\n\r\n          -  Chemotherapy or radiotherapy less than 6 weeks ago\r\n\r\n          -  Immunotherapy less than 8 weeks ago\r\n      ","sponsor":"Centre Hospitalier Universitaire Dijon","sponsor_type":"Other","conditions":"Solid Tumors","interventions":[{"intervention_type":"Biological","name":"Biological: Injections of OM-174"}],"outcomes":[{"outcome_type":"primary","measure":"The occurrence of any adverse event","time_frame":"up to 8 weeks"}]}
{"nct_id":"NCT00447655","start_date":"2007-03-31","phase":"Phase 1/Phase 2","enrollment":400,"brief_title":"Improving Outcomes Following Limb Loss: PALS Plus","official_title":"Improving Outcomes Following Limb Loss: PALS Plus","primary_completion_date":"2009-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-08-31","last_update":"2017-12-13","description":"Limb loss can result from a variety of etiologies including diabetes, trauma and cancer. Following limb loss, individuals are at elevated risk for activity limitations and participation restrictions with significant impact on health and quality of life. Intervention: Working with the Amputee Coalition of America we have developed, evaluated, and established the effectiveness of a self-management program (PALS) to improve health and outcomes following limb loss. Literature suggests that the access to, and effectiveness and utilization of, this class of interventions may be enhanced by the concerted use of early intervention, peer mentorship, motivational interviewing and provider training. Objectives: Our goal is to evaluate the effectiveness of an enhanced, early self-management intervention- PALS Plus. The specific aims are:1) evaluate the effectiveness of the PALS Plus intervention in improving outcomes for persons with limb loss; (2) evaluate the effectiveness of the PALS Plus intervention in maximizing utilization of self-management interventions for persons with limb loss. A cohort of 200 patients will be enrolled prior to implementation of the intervention and will serve as the control group. Subsequently, a second cohort of 200 patients will be enrolled and receive the PALS Plus intervention and will serve as the intervention group. Assessment will be at baseline, treatment completion and six month follow-up. Outcomes: Primary outcome measures are: pain, depressed mood, and positive mood. Secondary outcome measures are: function, participation and bothersomeness of limitations. The investigation will also provide unique and valuable information regarding patients' acceptance and use of peer visitation and self-management following limb loss. Relevance: By establishing the utility and effectiveness of the enhanced self-management intervention, there is the potential to improve the health, activity, participation and quality of life for individuals with disabilities. The intervention addresses the areas of activity and participation in such a way that it can be implemented in local health care facilities working in combination with a national consumer based organization - the Amputee Coalition of America.","other_id":"CDC R01DD000153","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adults (aged 18-85 years) of both sexes and all races admitted to one of the seven\r\n             participating acute care hospitals or rehabilitation facilities for an amputation\r\n             procedure and/or treatment immediately following an amputation procedure, including\r\n             traumatic amputations as well as amputations due to complications for diabetes\r\n             mellitus, peripheral vascular disease, and malignancy.\r\n\r\n          -  Women and minority patients will be represented in the trial according to the gender\r\n             and race/ethnic prevalence of patients receiving treatment at the designated hospital\r\n             and rehabilitation centers.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Criteria for exclusion from the study will include:\r\n\r\n          -  Age less than 18 or over 85 years; and\r\n\r\n          -  Inability to communicate in written or spoken English.\r\n      ","sponsor":"Johns Hopkins University","sponsor_type":"Other","conditions":"Amputation","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Self-management and peer support"}],"outcomes":[{"outcome_type":"primary","measure":"Primary outcome measures are: pain, depressed mood, and positive mood."},{"outcome_type":"secondary","measure":"Secondary outcome measures are: function, participation and bothersomeness of limitations"}]}
{"nct_id":"NCT00457067","start_date":"2007-03-27","phase":"Phase 1","enrollment":5,"brief_title":"Injected Ranibizumab to Treat Macular Telangiectasia With New Blood Vessel Formation","official_title":"Pilot Study of Intravitreal Injection of Ranibizumab for Macular Telangiectasia With Neovascularization","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-10-24","last_update":"2017-07-02","description":"This study will examine whether the drug ranibizumab is an effective treatment for macular telangiectasia, a condition in which existing blood vessels near the macula (the back part of the eye responsible for sharp central vision) become dilated and twisted, and new abnormal blood vessels may form under the retina. Both the existing dilated vessels, as well the new subretinal vessels can leak fluid and blood, distort the retina, and affect vision. This study will see if ranibizumab can slow or stop the leakage and growth of new vessels forming under the retina. Patients 18 years of age and older who have macular telangiectasia in both eyes and new blood vessel formation under the retina in at least one eye may be eligible for this study. Visual acuity must be 20/40 or worse. Participants receive at least four injections of ranibizumab into the eye over a 12-week period. After the fourth injection, additional injections may be given every 4 weeks for up to 1 year if the doctor determines that they may be of benefit. In addition to ranibizumab treatment, patients undergo the following procedures: - Medical history and physical examination. - Eye examination, including dilation of the pupils and measurement of the fluid pressure in the eye. - Fluorescein angiogram: A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. Photographs of the retina are taken with a special camera that flashes a blue light into the eye. The photos show whether any dye has leaked from the vessels into the retina. - Indocyanine green angiography: This procedure identifies feeder vessels that may be supplying the abnormal blood vessels. The test is similar to fluorescein angiography, but uses a green dye and flashes an invisible light. - Autofluorescence imaging: This test examines how well the retina functions. The back of the eye is photographed with a bright light. - Optical coherence tomography: This test measures retinal thickness. A light shined into the eye produces cross-sectional pictures of the retina. The measurements are repeated during the study to determine if retinal thickening is getting better or worse, or staying the same. - Stereoscopic color fundus photography: The pupils are dilated and special photographs of the inside of the eye are taken to evaluate the retina and measure changes that occur over time. The camera flashes a bright light into the eye for each picture. - Follow-up visits: The doctor evaluates the effects of the study treatment before and after each injection. Patients are contacted by phone 3 days after each injection to check on any treatment side effects. A final follow-up visit is scheduled 8 weeks after the last treatment.","other_id":"070095","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        -  INCLUSION CRITERIA:\r\n\r\n               1. Participant must understand and sign the informed consent.\r\n\r\n               2. Participant must be at least 18 years of age.\r\n\r\n               3. Participant must have macular telangiectasia in both eyes.\r\n\r\n               4. Participant must have neovascularization in the study eye.\r\n\r\n               5. Participant must have vision loss of 20/40 or worse.\r\n\r\n               6. Participant must have clear ocular media and adequate papillary dilation to\r\n                  permit good quality stereoscopic fundus photography.\r\n\r\n               7. All women of childbearing potential must have a negative urine pregnancy test at\r\n                  baseline, and be willing to undergo testing immediately prior to each injection\r\n                  and monthly for at least 2 months following the last dose of ranibizumab.\r\n\r\n               8. Women of child-bearing potential who are sexually active and men who are sexually\r\n                  active are required to use two forms of birth control during the course of the\r\n                  study.\r\n\r\n        EXCLUSION CRITERIA:\r\n\r\n          1. History (within past 5 years) or evidence of severe cardiac disease (apparent in\r\n             electrocardiogram abnormalities, clinical history of unstable angina, acute coronary\r\n             syndrome, myocardial infarction, revascularization procedure within 6 months prior to\r\n             baseline, atrial or ventricular tachyarrythmias requiring ongoing treatment).\r\n\r\n          2. History of stroke within 12 months of study entry.\r\n\r\n          3. History within the past five years of a chronic ocular or periocular infection\r\n             (including any history of ocular herpes zoster).\r\n\r\n          4. Current acute ocular or periocular infection.\r\n\r\n          5. Any major surgical procedure within one month of study entry.\r\n\r\n          6. Known serious allergies to fluorescein dye.\r\n\r\n          7. Previous participation in a clinical trial (for either eye) involving anti-angiogenic\r\n             drugs (pegaptanib, ranibizumab, bevacizumab, anecortave acetate, Protein Kinase C\r\n             inhibitors, etc.).\r\n\r\n          8. Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or\r\n             device implantation) in the study eye.\r\n\r\n          9. History of vitrectomy surgery in the study eye.\r\n\r\n         10. History of glaucoma filtering surgery in the study eye.\r\n\r\n         11. History of corneal transplant in the study eye.\r\n      ","sponsor":"National Eye Institute (NEI)","sponsor_type":"NIH","conditions":"Telangiectasia","interventions":[{"intervention_type":"Drug","name":"Drug: Ranibizumab"}],"outcomes":{}}
{"nct_id":"NCT00454350","start_date":"2007-02-28","phase":"Phase 4","enrollment":12,"brief_title":"A Phase 4 Pharmacokinetic Study of Hectorol Injection and Zemplar Injection in CKD Subjects on Hemodialysis","official_title":"A Randomized , Open-Label, Cross-over, Pharmacokinetic Study of Doxercalciferol and Paricalcitol Following Multiple Intravenous Injections in Chronic Kidney Disease Subjects on Hemodialysis","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-07-31","last_update":"2015-05-05","description":"This study will measure serum levels of the active Vitamin D compound that circulates in hemodialysis subjects treated with either doxercalciferol injection (Hectorol) or Zemplar (paricalcitol injection).","other_id":"HECT00106","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  The subject must be receiving hemodialysis three times per week for a minimum of three\r\n             months.\r\n\r\n          -  The subject must be receiving intravenous doxercalciferol or paricalcitol at each\r\n             dialysis session (three times weekly) for a minimum of 12 weeks prior to Screening.\r\n\r\n          -  At Screening Visit the subject's laboratory measurements must be within the following\r\n             ranges: Serum iPTH measurement between 150-800 pg/mL; Corrected calcium measurement \r\n             10.5 mg/dL; Serum phosphorus measurement  7 mg/dL\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any ongoing use of over the counter or prescription vitamin D preparations except\r\n             doxercalciferol or paricalcitol injection or multivitamins.\r\n\r\n          -  History of heparin-induced thrombocytopenia.\r\n      ","sponsor":"Genzyme, a Sanofi Company","sponsor_type":"Industry","conditions":"Secondary Hyperparathyroidism","interventions":[{"intervention_type":"Drug","name":"Drug: Hectorol (doxercalciferol injection)"},{"intervention_type":"Drug","name":"Drug: Zemplar (Paricalcitol injection)"}],"outcomes":[{"outcome_type":"primary","measure":"Pharmacokinetic Study","time_frame":"44 hour interval"}]}
{"nct_id":"NCT00810420","start_date":"2007-02-28","brief_title":"EEG-Changes During Insulininduced Hypoglycemia in Type 1 Diabetes","official_title":"EEG-Changes During Insulininduced Hypoglycemia in Type 1 Diabetes","primary_completion_date":"2007-10-31","study_type":"Observational","rec_status":"Completed","completion_date":"2008-04-30","last_update":"2008-12-18","description":"The aim of this study is based on recent pilot studies carried out at Odense University Hospital showing that the acute changes in electroencephalographic (EEG) signals (i.e. electrical activity inthe brain) elicited by insulin-induced hypoglycemia in patients with type 1 diabetes can be reliable detected by real-time processing of these EEG signals using mathematical algorithms and state of the art noise and artifact reduction. These preliminary results also showed that the hypoglycemia-induced EEG changes are detectable 15-30 min before deterioration in cognitive function impedes an adequate response to warning. We hypothesize that these observations apply to the majority of patients with type 1 diabetes, and therefore, that it is possible to develop an automated device to detect hypoglycemic episodes by continuous real-time monitoring and processing of EEG signals. To test our hypothesis, the specific aims of the present proposal are: 1. Detection of hypoglycemia-induced EEG changes using subcutaneous electrodes 2. Ambulatory EEG monitoring using subcutaneous electrodes","other_id":"Hyposafe-hypo-01","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"Twenty adult patients with type 1 diabetes will be participating in the study.","criteria":"\n        Inclusion Criteria\r\n\r\n          -  18-60 year old subjects\r\n\r\n          -  Type 1 diabetics with complete or partial hypoglycemia unawareness.\r\n\r\n          -  Ability to comprehend and a willingness to sign an informed consent form\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Neurological or psychiatric disease.\r\n\r\n          -  Current use of neuroactive medication or recreational drugs.\r\n\r\n          -  Pregnancy.\r\n\r\n          -  Patients with known heart disease, former myocardial infarction or cardiac arrhythmia\r\n\r\n          -  Patients with known epilepsy or in treatment with anti-epileptic drugs for all\r\n             purposes\r\n\r\n          -  Patients treated with drugs that are known to influence the EEG, including\r\n             benzodiazepines and other anxiolytics, anti-depressants and beta-blocking agents\r\n\r\n          -  Patients that are judged incapable of understanding the patient information or who are\r\n             not capable of carrying through the investigation\r\n\r\n          -  Cancer of any kind\r\n      ","sponsor":"UNEEG Medical A/S","sponsor_type":"Industry","conditions":"Hypoglycemia|Type 1 Diabetes","interventions":{},"outcomes":{}}
{"nct_id":"NCT00923897","start_date":"2007-02-28","phase":"Phase 2","enrollment":40,"brief_title":"Palliative Radiotherapy (RT) for Liver Metastases (Mets) and Hepatocellular Carcinoma (HCC)(COLD 4)","official_title":"Phase II Trial of Palliative Radiotherapy for Locally Advanced Hepatocellular Carcinoma and Hepatic Metastases","primary_completion_date":"2018-09-26","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-09-26","last_update":"2019-06-18","description":"Palliative radiotherapy is radiation treatment given to help reduce pain or discomfort, or other symptoms related to cancer. This is used commonly for cancer that has spread to the bones and brain, and for many other primary cancers that are too advanced to be cured, including lung cancer, pancreatic cancer and head and neck cancer. The benefits of palliative radiotherapy for advanced liver cancer have not been well studied. This study is designed to help to see whether palliative radiation therapy is effective in controlling pain, discomfort or other symptoms related to liver cancer, and how this therapy Phase II Trial of Palliative Radiotherapy for Locally Advanced Hepatocellular Carcinoma and Hepatic Metastases might affect the quality of life of patients receiving such therapy. This information will help the doctors understand if there are specific conditions under which radiation therapy is more effective and worthwhile, and how it may affect the quality of life for patients who have locally advanced hepatocellular carcinoma and hepatic metastasis.","other_id":"UHN REB 07-0020-CE","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with hepatocellular carcinoma or hepatic metastases from a solid malignancy,\r\n             unsuitable for radical therapy (including resection, transplant, conformal high dose\r\n             radiotherapy), confirmed by biopsy or imaging\r\n\r\n          -  Symptoms of hepatic pain, discomfort, nausea, or fatigue requiring palliation\r\n\r\n          -  KPS>60\r\n\r\n          -  Expected survival of greater than 3 months\r\n\r\n          -  Platelet count > 25 bil/L, Hemoglobin > 70 g/L, INR<3, Bilirubin<100 umol/L, AST < 350\r\n             U/L or ALT< 400 U/L\r\n\r\n          -  Have signed an informed consent form approved by the Research Ethics Board (REB) at\r\n             Princess Margaret Hospital\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Chemotherapy or novel drug within the past 2 weeks\r\n\r\n          -  TACE(transarterial chemoembolization)within the past 1 month\r\n\r\n          -  Plan for active treatment of the hepatocellular carcinoma or hepatic metastases,\r\n             including TACE or RFA or ETOH injection\r\n      ","sponsor":"University Health Network, Toronto","sponsor_type":"Other","conditions":"Hepatocellular Carcinoma|Hepatic Metastasis","interventions":[{"intervention_type":"Radiation","name":"Radiation: Palliative RT","description":"Prior to receiving radiation treatment, it is recommended that you take medications to reduce the chance of nausea related to therapy. The treatment will take approximately 30 minutes."}],"outcomes":[{"outcome_type":"primary","measure":"To determine the change in index symptom(s) using an 11 point numerical rating scale for patients with locally advanced hepatocellular cancer or hepatic metastases treated with 8Gy","time_frame":"5 years"},{"outcome_type":"secondary","measure":"Determine the change in EORTC QLQ-C30 & FACT-Hep for patients with locally advanced HCC/hepatic metastases treated w/h 8Gy and assess the toxicity of treatment using CTC AE v3.0 toxicity score","time_frame":"5 years"},{"outcome_type":"secondary","measure":"To measure changes in serum cytokines and proteomics following radiotherapy.","time_frame":"5 years"},{"outcome_type":"secondary","measure":"To determine the feasibility of Cone Beam CT for simulation and treatment and optimize image quality offline.","time_frame":"5 years"},{"outcome_type":"secondary","measure":"To determine serum marker and radiographic response with 8Gy","time_frame":"5 years"}]}
{"nct_id":"NCT00527111","start_date":"2007-02-28","phase":"Phase 2","enrollment":139,"brief_title":"Pre-op Rectal ChemoRad +/- Cetuximab","official_title":"A Randomized Phase II Trial of Pre-operative Chemoradiotherapy With or Without Cetuximab (ERBITUX(R)) in Locally-advanced Adenocarcinoma of the Rectum","primary_completion_date":"2015-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-01-31","last_update":"2016-11-03","description":"The purpose of this research study is to find out what effects (good and bad) cetuximab has on rectal cancer.","other_id":"05102","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Note: Please see Section 8.1 for the necessary \"Prestudy Assessments\".\r\n\r\n        A patient will be eligible for inclusion in this study if s/he meets all of the following\r\n        criteria:\r\n\r\n          -  Has a histologically confirmed diagnosis of newly diagnosed adenocarcinoma of the\r\n             rectum (tumor within 15 cm of the anal verge). Location of tumor (lower 1/3rd vs.\r\n             middle or upper 1/3rd) and pre-treatment nodal status (N0 vs. N1 or N2) will be\r\n             recorded in the eCRF. Patients with only non-measurable disease are eligible as long\r\n             as they meet the other disease requirements in this criterion as well as all other\r\n             eligibility criteria.\r\n\r\n          -  Has tumor that is locally advanced (T3/T4 or lymph node positive) by preoperative\r\n             assessment with CT or MRI imaging or transrectal ultrasonography.\r\n\r\n          -  Has no evidence of distant metastases by radiographic staging\r\n\r\n          -  Has an ECOG Performance Status (PS) 0-1\r\n\r\n          -  Is greater than 18 years of age\r\n\r\n          -  Has adequate marrow and organ system function as assessed by the following lab values:\r\n\r\n        White blood cell (WBC) count See protocol for specific details Absolute neutrophil count\r\n        (ANC) See protocol for specific details Hemoglobin See protocol for specific details Total\r\n        bilirubin See protocol for specific details AST and ALT See protocol for specific details\r\n        Serum creatinine See protocol for specific details Platelet count See protocol for specific\r\n        details\r\n\r\n          -  Sexually active women of childbearing potential must use an effective method of birth\r\n             control during the course of the study, in a manner such that risk of failure is\r\n             minimized.\r\n\r\n        Prior to study enrollment, women of childbearing potential (WOCBP) must be advised of the\r\n        importance of avoiding pregnancy during trial participation and the potential risk factors\r\n        for an unintentional pregnancy. In addition, men enrolled on this study should understand\r\n        the risks to any sexual partner of childbearing potential and should practice an effective\r\n        method of birth control.\r\n\r\n        All WOCBP MUST have a negative pregnancy test within 3 weeks prior to registration\r\n        (confirmed within 7 days prior to first receiving investigational product). If the\r\n        pregnancy test is positive, the patient must not receive investigational product and must\r\n        not be enrolled in the study.\r\n\r\n        In addition, all WOCBP should be instructed to contact the Investigator immediately if they\r\n        suspect they might be pregnant (eg, missed or late menstrual period) at any time during\r\n        study participation.\r\n\r\n        The Investigator must immediately notify BMS in the event of a confirmed pregnancy in a\r\n        patient participating in the study.\r\n\r\n          -  Has signed a Patient Informed Consent Form\r\n\r\n          -  Has signed a Patient Authorization Form\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  A patient will be excluded from this study if s/he meets any of the following\r\n             criteria:\r\n\r\n          -  Has another disease similar to one being studied (ie, colon cancer)\r\n\r\n          -  Has evidence of distant metastases by radiographic staging\r\n\r\n          -  Has had prior treatment for the current disease\r\n\r\n          -  Has had prior stem cell or bone marrow transplant or any organ transplant with the\r\n             exception of corneal transplant or cadaver bone graft\r\n\r\n          -  Has a history of hypersensitivity to any of study treatments\r\n\r\n          -  Has had a prior severe infusion reaction to a monoclonal antibody\r\n\r\n          -  Has received prior therapy, at any time, which specifically and directly targets the\r\n             EGFR pathway\r\n\r\n          -  Has a significant history of uncontrolled cardiac disease; ie, uncontrolled\r\n             hypertension, unstable angina, recent myocardial infarction (within prior 6 months),\r\n             uncontrolled congestive heart failure, or cardiomyopathy with decreased ejection\r\n             fraction\r\n\r\n          -  Has evidence of CNS involvement (CNS imaging is not required for study enrollment\r\n             unless clinically suspected CNS disease is present.)\r\n\r\n          -  Has a serious uncontrolled intercurrent medical or psychiatric illness, including\r\n             serious infection or Gilbert's Syndrome\r\n\r\n          -  Has a history of other malignancy within the last 5 years (except cured basal cell\r\n             carcinoma of skin and carcinoma in situ of uterine cervix), which could affect the\r\n             diagnosis or assessment of any of the study drugs. Patients, who have received prior\r\n             radiotherapy to any regional site other than the pelvis, as long as all other\r\n             inclusion criteria are met, could be considered for enrollment after discussion with\r\n             Dr. McCollum.\r\n\r\n          -  Is a pregnant or nursing woman\r\n\r\n          -  Is unable to comply with requirements of study\r\n      ","sponsor":"US Oncology Research","sponsor_type":"Industry","conditions":"Rectal Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Cetuximab"},{"intervention_type":"Drug","name":"Drug: 5-fluorouracil"},{"intervention_type":"Radiation","name":"Radiation: Pelvic irradiation"}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of Pathologic Response Rate (pCR) With 95% Confidence Interval.","time_frame":"5 years","description":"A pathologic complete response (pCR) is defined as no pathologic evidence of invasive disease at the primary site in the bowel wall or in examined mesorectal tissue and/or lymph nodes."},{"outcome_type":"secondary","measure":"To Determine Objective Response Rate (ORR) Based on RECIST Local Recurrence-free Survival in These Patient Groups; Overall and Recurrence-free Survival in These Cohorts.","time_frame":"5 years","description":"Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD."},{"outcome_type":"secondary","measure":"5- Year Overall Survival (OS) Rate","time_frame":"5 years","description":"Overall survival is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the date of last contact."},{"outcome_type":"secondary","measure":"Recurrence-free Survival (RFS) Rate at 5 Years","time_frame":"5 years","description":"RFS is measured from the date of randomization to the date of first documented disease recurrence or date of death, whichever comes first. If a patient neither recurrences nor dies, this patient will be censored at the date of last contact."},{"outcome_type":"secondary","measure":"KRAS Mutation Rate","time_frame":"5 years","description":"Percentage of Participants with KRAS mutation."}]}
{"nct_id":"NCT00396682","start_date":"2007-02-28","phase":"Phase 3","enrollment":12,"brief_title":"Elimination of CD4+CD25+ Regulatory T Cells in Patients With Hepatocellular Carcinoma","official_title":"Elimination of CD4+CD25+ Regulatory T Cells in Patients With Advanced HCC After Treatment With Cyclophosphamide","primary_completion_date":"2008-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-12-31","last_update":"2009-02-04","description":"It has been shown that patients with advanced HCC have an increased frequency of CD4+CD25+ regulatory T cells. These cells might suppress tumor-specific immune responses. Cyclophosphamide has been shown to reduce the frequency of CD4+CD25+ regulatory T cells. The aim of this study is to test if the treatment with cyclophosphamide leads to a decrease in the frequency of CD4+CD25+ regulatory T cells and to increase tumor specific immune responses in patients with advanced HCC.","other_id":"HAN-HCC-002","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  adequate WBC\r\n\r\n          -  adequate liver and kidney function\r\n\r\n          -  no immunodeficiency\r\n\r\n          -  ECOG < 2\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  advanced liver cirrhosis\r\n\r\n          -  severe cardiopulmonary diseases\r\n      ","sponsor":"Hannover Medical School","sponsor_type":"Other","conditions":"Advanced HCC","interventions":[{"intervention_type":"Drug","name":"Drug: Cyclophosphamide","description":"150 - 250 - 350 mg"}],"outcomes":[{"outcome_type":"primary","measure":"Frequency of CD4+CD25+regulatory T cells","time_frame":"within 8 weeks"},{"outcome_type":"primary","measure":"Tumor specific immune responses","time_frame":"within 12 weeks"},{"outcome_type":"secondary","measure":"Toxicity","time_frame":"within 8 weeks"},{"outcome_type":"secondary","measure":"Function and Phenotype of CD4+CD25+ regulatory T cells","time_frame":"within 12 weeks"},{"outcome_type":"secondary","measure":"Tumor response","time_frame":"within 12 weeks"},{"outcome_type":"secondary","measure":"Survival","time_frame":"6 months"}]}
{"nct_id":"NCT00468572","start_date":"2007-02-28","phase":"N/A","enrollment":120,"brief_title":"Using Affectionate Communication as a Response to Acute Stress","official_title":"Affectionate Communication as a Mechanism for Responding to Acute Stress","primary_completion_date":"2007-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-12-31","last_update":"2012-01-10","description":"This study will examine the effects of tending to significant social relationships on managing and reducing stress.","other_id":"R03MH075757","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Basic Science","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  English-speaking\r\n\r\n          -  Weigh at least 110 pounds\r\n\r\n          -  Moderate to no anxiety about having blood drawn\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Hypertension or diabetes\r\n\r\n          -  Current or recent pregnancy\r\n\r\n          -  Colorblindness\r\n\r\n          -  History of cancer\r\n\r\n          -  Current use of alpha blockers, beta blockers, or steroids\r\n      ","sponsor":"Arizona State University","sponsor_type":"Other","conditions":"Stress","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Affectionate Writing","description":"Participants assigned to the experimental group will spend 20 minutes writing an affectionate letter to a loved one. Levels of cortisol will be measured using saliva samples from each participant during the writing session. Levels of oxytocin, a hormone known to transmit signals within the brain and often associated with bonding and building trusting relationships, will be measured from blood samples taken during the writing session as well."},{"intervention_type":"Behavioral","name":"Behavioral: Meaningless Writing","description":"Participants assigned to the control group will spend 20 minutes writing about meaningless topics. Participants will undergo the same testing during the writing session as the experimental group."}],"outcomes":[{"outcome_type":"primary","measure":"Oxytocin levels","time_frame":"Measured at Hour 2"},{"outcome_type":"primary","measure":"Cortisol levels","time_frame":"Measured at Hour 2"},{"outcome_type":"secondary","measure":"Self-reported stress level","time_frame":"Measured at Hour 2"}]}
{"nct_id":"NCT00669643","start_date":"2007-02-28","phase":"Phase 4","enrollment":859,"brief_title":"Uniform Multidrug Therapy Regimen for Leprosy Patients","official_title":"Independent Study to Establish the Efficacy of the Six Doses Uniform MDT Regimen (U-MDT) for Leprosy Patients","primary_completion_date":"2012-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-12-31","last_update":"2017-06-01","description":"The purpose of this randomized trial is to verify if leprosy patients, despite of their classification, can be treated with the same regimen without compromising patient cure and acceptability of the treatment. At present, patients classified as multibacillary leprosy are treated for 12 months with three drugs, and patients classified as paucibacillary leprosy are treated for 6 months with two drugs. The study is going to test a unified regimen for paucibacillary and multibacillary patients by treating leprosy patients with three drugs for 6 doses.","other_id":"CNPq / DECIT 403293/2005-7","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":6,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  All newly diagnosed leprosy cases with characteristic skin lesions, with or without\r\n             systemic symptoms or confirmed by histopathological study previously untreated PB and\r\n             MB leprosy patients.\r\n\r\n          -  Never treated or patient treated more than five years ago\r\n\r\n        Exclusion Criteria:\r\n\r\n        Safety concerns:\r\n\r\n          -  History of intolerance to one of the medications\r\n\r\n        Lack of suitability for the trial:\r\n\r\n          -  Absence of leprosy skin lesions\r\n\r\n          -  Pure neural leprosy (PNL)\r\n\r\n          -  Patient previously (defaulters and relapse) treated for leprosy less than 5 years ago\r\n\r\n          -  Association with other serious diseases such as HIV/AIDS, Tuberculosis, Malaria,\r\n             American Cutaneous leishmaniasis, Visceral Leishmaniasis, Lymphoma, Leukaemia,\r\n             Immunosuppression, etc.\r\n\r\n        Administrative reasons\r\n\r\n          -  Patients who are not permanent residents of the area or who are unable to come to the\r\n             clinic every month during their treatment and in the first half year (the intensive\r\n             follow-up period) after their treatment.\r\n\r\n          -  Patients who do not give informed consent or are not capable to give informed consent\r\n             due to mental impairment.\r\n\r\n          -  Patients with overt signs of AIDS because it is unlikely that we can follow them up\r\n             for the whole study period. As we will not be testing patients for HIV positivity,\r\n             HIV-infected leprosy patients can be included in the study.\r\n      ","sponsor":"University of Brasilia","sponsor_type":"Other","conditions":"Leprosy","interventions":[{"intervention_type":"Drug","name":"Drug: PB 6 doses - Rifampicin and Dapsone","description":"Adult: 6 doses;\r\n1 monthly supervised dose: 600 mg Rifampicin + 100 mg Dapsone; 27 days: p/day - 100 mg Dapsone;\r\nChildren: 6 doses;\r\n1 monthly supervised dose: 450 mg Rifampicin + 50 mg Dapsone; 27 days: p/day - 50 mg Dapsone"},{"intervention_type":"Drug","name":"Drug: PB 6 doses - Rifampicin, Clofazimine and Dapsone","description":"Adult: 6 doses;\r\n1 monthly supervised dose: 600 mg Rifampicin + 300 mg Clofazimine + 100 mg Dapsone; 27 days: p/day - 100 mg Dapsone + 50 mg Clofazimine;\r\nChildren: 6 doses;\r\n1 monthly supervised dose: Rifampicin 450 mg + 150 mg Clofazimine + 50 mg Dapsone; 27 days: p/day - 50 mg Dapsone + 25 mg Clofazimine"},{"intervention_type":"Drug","name":"Drug: MB 12 doses - Rifampicin, Clofazimine and Dapsone","description":"Adult: 12 doses;\r\n1 monthly supervised dose: 600 mg Rifampicin + 300 mg Clofazimine + 100 mg Dapsone; 27 days: p/day - 100 mg Dapsone + 50 mg Clofazimine;\r\nChildren: 12 doses;\r\n1 monthly supervised dose: Rifampicin 450 mg + 150 mg Clofazimine + 50 mg Dapsone; 27 days: p/day - 50 mg Dapsone + 25 mg Clofazimine"},{"intervention_type":"Drug","name":"Drug: MB 6 doses - Rifampicin, Clofazimine and Dapsone","description":"Adult: 6 doses\r\n1 monthly supervised dose: 600 mg Rifampicin + 300 mg Clofazimine + 100 mg Dapsone; 27 days: p/day - 100 mg Dapsone + 50 mg Clofazimine\r\nChildren: 6 doses\r\n1 monthly supervised dose: Rifampicin 450 mg + 150 mg Clofazimine + 50 mg Dapsone; 27 days: p/day - 50 mg Dapsone + 25 mg Clofazimine"}],"outcomes":[{"outcome_type":"primary","measure":"Relapse","time_frame":"5 years"},{"outcome_type":"secondary","measure":"Type I Reaction - Reversal Reactions","time_frame":"6 years"},{"outcome_type":"secondary","measure":"Type II Reaction - Erythema nodosum leprosum","time_frame":"6 years"},{"outcome_type":"secondary","measure":"Neurological damage","time_frame":"6 years"},{"outcome_type":"secondary","measure":"Neuritis","time_frame":"6 years"}]}
{"nct_id":"NCT00448786","start_date":"2007-02-28","phase":"Phase 1","enrollment":49,"brief_title":"Effect of Different Doses of AMG 706 on the Gallbladder in Advanced Solid Tumors","official_title":"An Open-Label, Randomized, Phase 1b Study Evaluating the Effect of Different Doses of AMG 706 on the Gallbladder in Subjects With Advanced Solid Tumors","primary_completion_date":"2008-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-03-31","last_update":"2011-01-21","description":"The study involves the use of three different dosing regimens of AMG 706 in patients with advanced solid tumors to see how the drug affects the gallbladder size and function. The study will be conducted in 11 sites in the US and Australia. A total of 48 patients will be enrolled in the study with the possibility of enrolling 8 more in each treatment arm.","other_id":"20060443","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically confirmed advanced metastatic solid tumor\r\n\r\n          -  Ineligible to receive or progressed on standard of care therapies\r\n\r\n          -  Measurable or non-measurable disease per modified RECIST\r\n\r\n          -  Gallbladder must be in situ on screening ultrasound\r\n\r\n          -  ECOG Performance Status of 0 to 2\r\n\r\n          -  Life expectancy of 6 months or more as determined by the investigator\r\n\r\n          -  Adequate organ and hematologic function as evidenced by laboratory studies prior to\r\n             randomization\r\n\r\n          -  Men and women 18 years or older\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Uncontrolled CNS metastases\r\n\r\n          -  Known history of prior cholecystitis, prior biliary procedure or prior or ongoing\r\n             biliary disease\r\n\r\n          -  Radiation therapy within 14 days prior to randomization\r\n\r\n          -  Peripheral neuropathy > Grade 1 per CTC AE v.3\r\n\r\n          -  Currently or previously treated with AMG 706 or other VEGF inhibitors such as SU11248\r\n             (sunitinib), PTK787 (vatalanib), AZD2171, BAY 43-9006 (sorafenib), ZD6474 (vandetanib)\r\n\r\n          -  Previous treatment with bevacizumab is allowed if at least 6 weeks have elapsed from\r\n             the last dose of bevacizumab to the date of randomization\r\n\r\n          -  Any anti-coagulant therapy within 7 days prior to randomization; low dose heparin and\r\n             warfarin for prophylaxis against central venous catheter thrombosis is allowed\r\n\r\n          -  Less than 30 days have elapsed since participation in an investigational drug/device\r\n             study or currently receiving investigational treatments\r\n\r\n          -  History of arterial or venous thrombosis within 1 year prior to randomization\r\n\r\n          -  History of bleeding diathesis or bleeding within 14 days of randomization\r\n\r\n          -  MI, CVA, TIA, PTCA/stent, CHF, Grade 2 or greater PVD, uncontrolled arrhythmias or\r\n             unstable angina within one year prior to randomization\r\n\r\n          -  Uncontrolled HTN defined by a resting BP of >150/90 mmHg\r\n\r\n          -  Surgery: major surgical procedure within 4 weeks or 28 days prior to randomization;\r\n             minor surgical procedure, placement of access device or fine needle aspiration within\r\n             7 days of randomization; planned elective surgery while on study\r\n\r\n          -  Non-healing or open wound, ulcer or fracture\r\n\r\n          -  Known ongoing or active infection\r\n\r\n          -  Known (+) for HIV, Hep C or Hep B surface antigen\r\n\r\n          -  Known chronic hepatitis\r\n\r\n          -  Known history of allergy or hypersensitivity to AMG 706 or any of its components\r\n\r\n          -  Pregnant, ie, (+) b-HCG; breastfeeding\r\n      ","sponsor":"Amgen","sponsor_type":"Industry","conditions":"Solid Tumors","interventions":[{"intervention_type":"Drug","name":"Drug: AMG 706","description":"Arm B - AMG 706 75 mg BID 2-weeks on and 1-week off"},{"intervention_type":"Drug","name":"Drug: AMG 706","description":"Arm C - 75 mg BID 5-days on, 2-days off"},{"intervention_type":"Drug","name":"Drug: AMG 706","description":"AMG 706 125 mg daily continuously (Arm A)"}],"outcomes":[{"outcome_type":"primary","measure":"Average change from baseline in gallbladder size (volume by ultrasound)","time_frame":"Anticipated 8 months of treatment with AMG 706"},{"outcome_type":"primary","measure":"Average change from baseline in gallbladder function (ejection fraction)","time_frame":"Subject treatment with AMG 706 anticipated to be 8 months"},{"outcome_type":"secondary","measure":"Average changes from baseline in gallbladder size (volume by CT scan)","time_frame":"Subject treatment with AMG 706 anticipated to be 8 months"},{"outcome_type":"secondary","measure":"Maximum change from baseline in gallbladder size (volume) and function (ejection fraction)","time_frame":"Subject treatment with AMG 706 anticipated to be 8 months"},{"outcome_type":"secondary","measure":"Change in gallbladder size (volume) and function (ejection fraction) between the last on-treatment measurement and the last available off-treatment measurement","time_frame":"Subject treatment with AMG 706 anticipated to be 8 months"},{"outcome_type":"secondary","measure":"Objective response in subjects with measurable disease at baseline","time_frame":"Subject treatment with AMG 706 anticipated to be 8 months"},{"outcome_type":"secondary","measure":"Pharmacokinetics of AMG 706 monotherapy","time_frame":"Subject treatment with AMG 706 anticipated to be 8 months"},{"outcome_type":"secondary","measure":"Subject incidence of treatment-emergent adverse events (including all, serious, grade 3, grade 4 and treatment-related","time_frame":"Subject treatment with AMG 706 anticipated to be 8 months"},{"outcome_type":"secondary","measure":"Other selected gallbladder characteristics such as size, area, wall thickness, ductal size, presence of stones, pericholecystic fluid and sludge","time_frame":"Subject treatment with AMG 706 anticipated to be 8 months"}]}
{"nct_id":"NCT00254644","start_date":"2007-02-28","enrollment":32,"brief_title":"Morphofunctional Imaging and Developmental Dyslexia","official_title":"Morphofunctional Imaging and Developmental Dyslexia","primary_completion_date":"2008-02-29","study_type":"Observational","rec_status":"Completed","completion_date":"2008-02-29","last_update":"2017-01-16","description":"Developmental dyslexia is a frequent learning disability. The aim of this study is to analyze cortical thickness and phonological treatment in right handed adults with developmental dyslexia. They are compared to control adults paired with age and laterality. To study phonological treatment, the researchers used functional magnetic resonance imaging (fMRI) with a rime judgement task and silent word generation.","other_id":"PHRR04-CH/DYS","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"Male","minimum_age":18,"maximum_age":35,"population":"This is a prospective study including 15 right-handed male subjects, aged 18 to 35 years,\r\n        carrying a developmental dyslexia and 15 control subjects handed the same sex. We chose to\r\n        include only male subjects to obtain a homogeneous population and to avoid the problem of a\r\n        functional organization differs according to gender.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Developmental dyslexia according to Critchley.\r\n\r\n          -  Normal performance intelligence quotient (PIQ)\r\n\r\n          -  Age: 18-35 years\r\n\r\n          -  Sex: Male\r\n\r\n          -  Right handed\r\n\r\n          -  No hearing deficit.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  No head injury\r\n\r\n          -  No attention deficit hyperactivity disorder (ADHD)\r\n      ","sponsor":"University Hospital, Tours","sponsor_type":"Other","conditions":"Developmental Dyslexia","interventions":[{"intervention_type":"Procedure","name":"Procedure: Morphological and functional MRI","description":"one time"}],"outcomes":[{"outcome_type":"primary","measure":"Cortical thickness","time_frame":"2 years","description":"The average cortical thickness maps of healthy subjects and dyslexic will be compared hemisphere by hemisphere. This will identify whether there are cortical areas including cortical thickness differed significantly between normal and dyslexic.ts of different ages"},{"outcome_type":"secondary","measure":"Average cortical thickness","time_frame":"2 years","description":"For each group, cortical thickness maps of average left and right hemispheres are compared. This will identify whether there is an asymmetry left / right in terms of cortical thickness in normal subjects and dyslexic."}]}
{"nct_id":"NCT00449384","start_date":"2007-02-28","enrollment":59,"brief_title":"SIB-Norwegian Version, Validation and Reliability Study","official_title":"Severe Impairment Study - Norwegian Version. A Validation and Reliability Study.","study_type":"Observational","rec_status":"Completed","completion_date":"2007-05-31","last_update":"2007-07-03","description":"The purpose of this study is to validate and to test interrater reliability for the Norwgian version of Severe Impairment Battery (SIB).","other_id":"F06002","observational_model":"Defined Population","time_perspective":"Other","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Dementia, mild to severe.\r\n\r\n          -  Nursing Home resident\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  No ability to write or read.\r\n\r\n          -  Physical handicapped, unable to use hands.\r\n      ","sponsor":"Sykehuset Innlandet HF","sponsor_type":"Other","conditions":"Dementia|Diagnostic Tests, Routine","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Diagnostic Screening"}],"outcomes":{}}
{"nct_id":"NCT00456651","start_date":"2007-02-28","phase":"N/A","enrollment":40,"brief_title":"Sleep Apnea-Hypopnea Syndrome and the Pathogenesis of Obesity","official_title":"Sleep Apnea-Hypopnea Syndrome and the Pathogenesis of Obesity","study_type":"Interventional","rec_status":"Unknown status","last_update":"2007-04-05","description":"The hypothesis of the study is the following: Patients with sleep apnea-hypopnea syndrome have different pattern in the secretion of hormones. The chronic sleep disorganization that suffer patients with sleep apnea-hypopnea syndrome (SAHS) may affect the central mechanisms that regulate nutritive behavior and energetic balance, causing an alteration in the secretion of hormones that favour the appearance and/or development of obesity.","other_id":"IB570/05","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":25,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Apnea-Hypopnea Index > 15\r\n\r\n          -  Body Mass Index < 27 or > 30 Kg/m2\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Presence of any chronic disease\r\n\r\n          -  Drug addiction and/or alcoholism\r\n\r\n          -  Refusal to sign informed consent\r\n      ","sponsor":"Sociedad Espaola de Neumologa y Ciruga Torcica","sponsor_type":"Other","conditions":"Sleep Apnea|Obesity","interventions":[{"intervention_type":"Device","name":"Device: CPAP (Continuous Positive Airway Pressure)"}],"outcomes":[{"outcome_type":"primary","measure":"OBJECTIVES: To compare the plasmatic profiles of different hormones"},{"outcome_type":"primary","measure":"and neuropeptides, related with weight control, metabolism and intake"},{"outcome_type":"primary","measure":"in patients with SAHS as well as in selected control subjects according"},{"outcome_type":"primary","measure":"to weight."},{"outcome_type":"secondary","measure":"CPAP (Continuous Positive Airway Pressure) effect on studied variables"}]}
{"nct_id":"NCT00584675","start_date":"2007-02-28","phase":"N/A","enrollment":0,"brief_title":"Nasopharyngeal 24 Hour pH Monitoring in Health Adult Volunteers","official_title":"Nasopharyngeal 24 Hour pH Monitoring in Health Adult Volunteers","primary_completion_date":"2008-01-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2008-02-29","last_update":"2015-06-19","description":"Involves a 24-hour pH probe study using the Dx-pH Measurement System on patients who do not have symptoms of laryngopharyngeal reflux or gastroesophageal reflux disease to establish normal values for the Dx-pH Measurement System.","other_id":"200714988-1","allocation":"N/A","intervention_model":"Single Group Assignment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18 years of age or older\r\n\r\n          -  no symptoms of laryngopharyngeal reflux or gastroesophageal reflux disease\r\n\r\n          -  score less than 10 on Reflux Symptom Index\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  age less than 18\r\n\r\n          -  known lidocaine allergy\r\n\r\n          -  history of heartburn, regurgitation, chronic cough, voice changes, globus pharyngeus,\r\n             excessive throat clearing, or swallowing problems\r\n\r\n          -  score 10 or greater on Reflux Symptom Index\r\n\r\n          -  current or past antacid use or other antireflux therapy\r\n\r\n          -  history of antireflux surgery\r\n\r\n          -  pregnancy\r\n\r\n          -  current anticoagulation therapy (warfarin, heparin, aspirin, clopidogrel bisulfate)\r\n\r\n          -  special/vulnerable populations (children, mentally handicapped, pregnant women,\r\n             fetuses, prisoners, cognitive impairment, life-threatening disease, social or economic\r\n             disadvantage)\r\n      ","sponsor":"University of California, Davis","sponsor_type":"Other","conditions":"Gastroesophageal Reflux Disease","interventions":[{"intervention_type":"Device","name":"Device: Dx-pH Measurement Probe","description":"Dx-pH Measurement Probe measures gaseous pH values in the nasopharynx and oropharynx over a period of 24 hours."}],"outcomes":[{"outcome_type":"primary","measure":"To develop a range of normal values in adults without symptoms of laryngopharyngeal reflux.","time_frame":"At completion of study"}]}
{"nct_id":"NCT00413699","start_date":"2007-02-05","phase":"Phase 3","enrollment":4488,"brief_title":"Long-Term Effectiveness And Safety Of CP-690,550 For The Treatment Of Rheumatoid Arthritis","official_title":"A Long-term, Open-label Follow-up Study Of Tofacitinib (Cp-690,550) For Treatment Of Rheumatoid Arthritis","primary_completion_date":"2016-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-10-26","last_update":"2018-10-30","description":"The purpose of this study is to determine the long-term effectiveness and safety of CP-690,550 for the treatment of rheumatoid arthritis. Subjects are eligible for this study only after participating in another \"qualifying\" study of CP-690,550 A sub-study will be conducted within the A3921024 study, this study will evaluate the immune response to pneumococcal and influenza vaccines in patients receiving CP-690,550","other_id":"A3921024","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subjects who have participated in a randomized \"qualifying\" study of CP-690,550 for\r\n             the treatment of rheumatoid arthritis\r\n\r\n        Vaccine sub-study visit\r\n\r\n          -  Subjects actively participating in Study A3921024 must have completed at least 3\r\n             months of continuous 10 mg BID CP-690,550 treatment in A3921024 as defined by >80%\r\n             compliance with prescribed dose consumption of CP-690,550 over the previous 3 months.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Serious medical conditions that would make treatment with CP-690,550 potentially\r\n             unsafe\r\n\r\n        Vaccine sub-study visit\r\n\r\n          1. Any documented influenza or pneumococcal infection within the last 3 months prior to\r\n             randomization in this study\r\n\r\n          2. Received any vaccine within 1 month prior to randomization in this study\r\n\r\n          3. Received an influenza vaccine within 6 months or a pneumococcal vaccine within 5 years\r\n             of randomization in this study.\r\n      ","sponsor":"Pfizer","sponsor_type":"Industry","conditions":"Arthritis, Rheumatoid","interventions":[{"intervention_type":"Drug","name":"Drug: CP-690,550","description":"5 mg PO BID open label; may increase to 10 mg PO BID to provide greater control of RA if no related AEs are present. May be off study drug temporarily for up to 28 days for mild to moderate AEs."},{"intervention_type":"Drug","name":"Drug: CP-690,550","description":"10 mg PO BID open label; may decrease to 5 mg PO BID for mild to moderate AEs. May be off study drug temporarily for up to 28 days for mild to moderate AEs."}],"outcomes":[{"outcome_type":"primary","measure":"Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports","time_frame":"Includes laboratory test abnormality data for all visits and adverse event data up to 999 days after last dose of study drug","description":"Treatment-emergent non serious AEs by System Organ Class (SOC) (all causalities) and Laboratory Test Abnormalities (without regard to baseline) The stated number of participants analyzed was the total number of participants in each group (AEs). The actual number of participants analyzed for each laboratory parameter varied, and is provided for each.\r\nAbs=absolute; ALT=alanine aminotransferase; AST=aspartate aminotransferase; ESR=erythrocyte sedimentation rate; GGT=gamma glutamyl transferase; hgb=hemoglobin; HDL=high density lipids; LDL=low density lipids; LLN=lower limit of normal; qual=qualitative; Tot=total; ULN=upper limit of normal; WBC=white blood cell"},{"outcome_type":"primary","measure":"Extension Period: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs)","time_frame":"Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months)","description":"An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events."},{"outcome_type":"primary","measure":"Extension Period: Number of Participants With Laboratory Test Abnormalities","time_frame":"Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months)","description":"Criteria for laboratory abnormalities: hemoglobin (Hg), hematocrit, red blood cell (RBC), high density lipoprotein (HDL) cholesterol:<0.8*lower limit of normal (LLN), platelet<0.5*LLN/>1.75*upper limit of normal (ULN), white blood cell (WBC)<0.6*LLN/>1.5*ULN, lymphocyte, neutrophil, protein, albumin <0.8*LLN/>1.2*ULN, basophil, eosinophil, monocyte, low density lipoprotein (LDL) cholesterol: >1.2*ULN; bilirubin>1.5*ULN, aspartate amino transferase(AT), alanine AT, gammaglutamyl transferase, alkaline phosphatase:>3.0*ULN; blood urea nitrogen, creatinine, cholesterol, triglyceride:>1.3*ULN; sodium <0.95*LLN/>1.05*ULN, potassium, chloride, calcium, bicarbonate: <0.9*LLN/>1.1*ULN; glucose<0.6*LLN/>1.5*ULN; Urine (specific gravity<1.003/>1.030, pH<4.5/>8, glucose, ketone, protein, blood/Hg(>=1; RBC, WBC>=20; creatinine kinase>2*ULN)."},{"outcome_type":"primary","measure":"Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis","time_frame":"Includes AEs for every visit and up to 999 days after last dose of study drug","description":"Treatment-emergent AEs by SOC (all causalities) - all participants, by time. Data presented for Post Month 96 includes data up to and including Month 114."},{"outcome_type":"primary","measure":"Extension Period: Percentage of Participants With Adverse Events and Who Discontinued Treatment Due to Adverse Events to Assess Long-term Safety and Tolerability of Tofacitinib","time_frame":"Baseline (Day 1 at Entry of Extension Period) up to Month 6 of Extension Period; Month 6 of Extension Period to Month 12 of Extension Period","description":"Long term safety and tolerability of Tofacitinib was measured as following: percentage (%) of participants with AEs, percentage of participants who discontinued due to AEs. An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship."},{"outcome_type":"secondary","measure":"Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses","time_frame":"Every visit until study completion","description":"The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented. ACR20 is defined as a 20% improvement from baseline in tender/painful joint count and swollen joint count, and at least 3 of the following 5 variables: Subject's Global Assessment of Arthritis, Physician's Global Assessment of Arthritis, Subject's Assessment of Arthritis Pain, Health Assessment Questionnaire - Disability Index, C-Reactive Protein (CRP). ACR50 is a 50% improvement and ACR70 a 70% improvement in these variables."},{"outcome_type":"secondary","measure":"Extension Period: Percentage of Participants With American College of Rheumatology (ACR) 20, 50, and 70 Responses","time_frame":"Month 3, 6, 9 and 12 of Extension Period","description":"ACR20=20 percent (%) improvement from baseline (Month 0 at entry of Initial Period) in tender/painful joint count and swollen joint count, and in at least 3 of 5 variables: participant's global assessment of arthritis (PtGA), physician's global assessment of arthritis (PGA), participant's assessment of arthritis pain (PtA), HAQ-DI, C-reactive protein. ACR50 is a 50% improvement and ACR70 is a 70% improvement in these variables. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PtA: participant assessed arthritis pain by 100 millimeter (mm) visual analogue scale, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability."},{"outcome_type":"secondary","measure":"Initial Period: Area Under American College of Rheumatology (ACR) n Curve","time_frame":"Not applicable as no data were collected for this endpoint.","description":"No data were collected for this endpoint because it was removed from the protocol in a previous amendment."},{"outcome_type":"secondary","measure":"Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR])","time_frame":"Every visit until study completion","description":"Descriptive statistics for DAS28-3 (CRP) and DAS28-4 (ESR). The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.\r\nDAS28 is a composite score, calculated using a mathematical formula, and is derived from the number of tender/painful joints (out of 28), number of swollen joints (out of 28), and a blood marker of inflammation (ESR or CRP). DAS28-4 also includes a score of general health in the formula.\r\nThe score range is from 0 to 9.4, with a higher score indicating more disease activity. A score of >5.1 indicates active disease, a score of ≤3.2 indicates low disease activity, and a score of <2.6 indicates disease remission."},{"outcome_type":"secondary","measure":"Extension Period: Change From Baseline in Disease Activity Score (DAS) 28-3 C-Reactive Protein (CRP)(DAS28-3 CRP) and DAS28-4 Erythrocyte Sedimentation Rate (ESR)(DAS28-4 ESR) at Month 3, 6, 9 and 12","time_frame":"Baseline (Month 0 at the entry of Initial period); Month 3, 6, 9 and 12 of Extension Period","description":"DAS28 is composite score, calculated using mathematical formula, derived from: 1) tender/painful joints count, out of 28 joints (TJC28), 2) swollen joints count, out of 28 joints (SJC28), 3) blood marker of inflammation (ESR [millimeter per hour] or CRP [milligram per liter]). DAS28-4 also include score of general health (GH). GH is general health or participants' global assessment of disease activity on 100 mm visual analog scale (GH score: 0 mm [very well] to 100 mm [extremely bad], higher scores = worse health condition). DAS28-3(CRP) = (0.56*sqrt[TJC28] + 0.28*sqrt[SJC28] + 0.36*ln[CRP+1]) *1.10 + 1.15) and DAS28-4(ESR) = (0.56*sqrt[TJC28] + 0.28*sqrt[SJC28] + 0.70*ln[ESR] + 0.014*GH), where sqrt = square root, ln = natural logarithm. DAS28-4 ESR and DAS28-3 CRP: score ranges from 0 (none) to 9.4 (extreme disease activity), with a higher score indicating more disease activity. Score of <=3.2 indicate low disease activity and score of <2.6 indicate disease remission."},{"outcome_type":"secondary","measure":"Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2","time_frame":"Every visit until study completion","description":"Percent participants with DAS28-4 (ESR) <2.6 and ≤3.2 and percent participants with DAS28-3 (CRP) <2.6 and ≤3.2. The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.\r\nDAS28 is a composite score, calculated using a mathematical formula, and is derived from the number of tender/painful joints (out of 28), number of swollen joints (out of 28), and a blood marker of inflammation (ESR or CRP). DAS28-4 also includes a score of general health in the formula.\r\nThe score range is from 0 to 9.4, with a higher score indicating more disease activity. A score of >5.1 indicates active disease, a score of ≤3.2 indicates low disease activity, and a score of <2.6 indicates disease remission."},{"outcome_type":"secondary","measure":"Extension Period: Percentage of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) Less Than (<) 2.6 and Less Than or (<=) 3.2","time_frame":"Baseline (Day 1 at the entry of Extension period); Month 3, 6, 9 and 12 of Extension Period","description":"DAS28 is composite score, calculated using mathematical formula, derived from: 1) tender/painful joints count, out of 28 joints (TJC28), 2) swollen joints count, out of 28 joints (SJC28), 3) blood marker of inflammation (ESR [millimeter per hour] or CRP [milligram per liter]). DAS28-4 also include score of GH. GH is general health or participants' global assessment of disease activity on 100 mm visual analog scale (GH score: 0 mm [very well] to 100 mm [extremely bad], higher scores = worse health condition). DAS28-3(CRP) = (0.56*sqrt[TJC28] + 0.28*sqrt[SJC28] + 0.36*ln[CRP+1]) *1.10 + 1.15) and DAS28-4(ESR) = (0.56*sqrt[TJC28] + 0.28*sqrt[SJC28] + 0.70*ln[ESR] + 0.014*GH), where sqrt = square root, ln = natural logarithm. DAS28-4 ESR and DAS28-3 CRP: score range is from 0 (none) to 9.4 (extreme disease activity), with a higher score indicating more disease activity. Score of <=3.2 indicate low disease activity and score of <2.6 indicate disease remission."},{"outcome_type":"secondary","measure":"Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score","time_frame":"Every visit until study completion","description":"Change from baseline by visit. HAQ-DI scores range from 0 to 3, where lower score implies less disease. A reduction from baseline in score indicates an improvement in condition. A clinically meaningful decrease from baseline is defined as a decrease of at least 0.22 units. The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented."},{"outcome_type":"secondary","measure":"Extension Period: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 3, 6, 9 and 12","time_frame":"Baseline (Month 0 at the entry of Initial Period); Month 3, 6, 9, and 12 of Extension Period","description":"HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 categories of daily living activities: dressing/grooming; arising; eating; walking; reach; grip; hygiene; and other activities. Each activity category consisted of 2-3 questionnaire. Each questionnaire was scored on a 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity that required assistance from another individual or required the use of an assistive device was adjusted to a score of 2 to represent a more limited functional status. Overall score was computed as the sum of total scores divided by the number of questionnaire answered. Total possible HAQ-DI score range: 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities."},{"outcome_type":"secondary","measure":"Initial Period: Short-Form-36 Health Survey (SF-36) Score","time_frame":"Every visit until study completion","description":"Change from Baseline for Physical Component and Mental Component Scores by visit. SF-36 is a health status measure of 8 general health domains, each scored on a 0 to 100 scale: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These domains can be summarized as physical and mental component scores. The domain scores were \"normed\" and the resulting component scores treated as Z-scores with a scale of negative to positive infinity. A higher score implies less disease. The greater the change from baseline, the greater the improvement. The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented."},{"outcome_type":"secondary","measure":"Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU)","time_frame":"Every visit until study completion","description":"Change from Baseline Scores for each: FACIT Fatigue Scale (score range 0 to 52, higher score indicates higher quality of life and an increase from baseline score indicates improvement), EuroQol EQ 5D (index values derived from a measure of central tendency and a measure of dispersion, an increase from baseline indicates improvement, score range 0 to 1), Work Limitations (WL) Physical Demands (covers ability to perform job tasks that involve bodily strength, a decrease from baseline indicates improvement, score range 0 to 100, higher scores indicating greater limitation), and RA Healthcare Resource Utilization Work Performance in Past 3 Months on Days Bothered by RA (assesses healthcare use over previous 3 months, a decrease from baseline indicates improvement, score range 0 to 10).\r\nThe stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented."},{"outcome_type":"secondary","measure":"Initial Period: Preservation of Joint Structure in Participants Who Had Baseline Radiographs Obtained in Their Qualifying Index Study","time_frame":"Every 6 months until study completion","description":"Modified Total Sharp Score per visit. Baseline score was the last available assessment from the index study. The Modified Total Sharp Score measures disease progression; increased scores indicate disease progression. Score range 0 (normal) to 448 (worst possible total score). The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed on each occasion varied, and is provided for each visit presented.\r\nTSS=Total Sharp Score"},{"outcome_type":"secondary","measure":"Vaccine Sub-study. Percent Achieving a Satisfactory Humoral Response to the Pneumococcal Vaccine as Defined by ≥ 2-fold Increase in Antibody Concentrations","time_frame":"From vaccine sub-study visit 2 (baseline) to sub-study visit 4","description":"Number (%) of participants achieving a satisfactory humoral response to the pneumococcal vaccine as defined by ≥2-fold increase in antibody concentration from vaccine sub-study visit 2 (vaccination baseline) in ≥6 of 12 anti-pneumococcal antigens (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) The number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.\r\n95% CI is based on Clopper-Pearson exact method for response rate."},{"outcome_type":"secondary","measure":"Vaccine Sub-study. Percent Achieving a Satisfactory Humoral Response to the Seasonal Influenza Vaccine as Defined by ≥ 4-fold Increase in Antibody Titers","time_frame":"From vaccine sub-study visit 2 (baseline) to sub-study visit 4","description":"Number of participants achieving a satisfactory humoral response to the seasonal influenza vaccine as defined by ≥4-fold increase in antibody titers from visit 2 (vaccination baseline) in ≥2 of 3 influenza antigens (HAI B, HAI H1N1, and HAI H3N2) The number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.\r\n95% CI is based on Clopper-Pearson exact method for response rate."},{"outcome_type":"secondary","measure":"Vaccine Sub-study. Percentage of Participants Achieving Protective Antibody Titers to the Seasonal Influenza Vaccine as Measured by a Hemagglutination Inhibition (HI) Assay Titer of ≥ 1:40 in ≥ 2 of 3 Influenza Antigens at Vaccine Sub-study Visit 3 and 4","time_frame":"From vaccine sub-study visit 2 (baseline) to sub-study visit 4","description":"Number (%) of participants achieving protective antibody titers to the seasonal influenza vaccine as measured by an HAI assay titer of ≥1:40 in ≥2 of 3 influenza antigens measured at vaccine sub-study visits 3 and 4.\r\nThe number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.\r\n95% CI is based on Clopper-Pearson exact method for response rate."},{"outcome_type":"secondary","measure":"Vaccine Sub-study. Percentage of Participants Who Respond to Each of the 12 Pneumococcal Antigens as Defined by ≥ 2-fold Increase in Antibody Concentrations From Vaccine Sub-study Visit 2 (Vaccination Baseline) Measured at Vaccine Sub-study Visit 4","time_frame":"From vaccine sub-study visit 2 (baseline) to sub-study visit 4","description":"Number (%) of participants achieving a satisfactory humoral response to the pneumococcal vaccine as defined by ≥2-fold increase in antibody concentration from vaccine sub-study visit 2 (vaccination baseline) in ≥6 of 12 anti-pneumococcal antigens (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) The number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.\r\n95% CI is based on Clopper-Pearson exact method for response rate."},{"outcome_type":"secondary","measure":"Vaccine Sub-study. Percentage of Participants Who Respond to Each of the 3 Influenza Antigens as Defined by ≥ 4-fold Increase in Antibody Titers From Vaccine Sub-study Visit 2 (Vaccination Baseline) Measured at Vaccine Sub-study Visit 4","time_frame":"From vaccine sub-study visit 2 (baseline) to sub-study visit 4","description":"Number (%) of participants achieving a satisfactory humoral response to the seasonal influenza vaccine defined as ≥4-fold increase in antibody titers from visit 2 (vaccination baseline) in ≥2 of 3 influenza antigens (HAI B, HAI H1N1, and HAI H3N2).\r\nThe number of participants was the number with a determinate antibody titer to the given vaccine antigen within the population.\r\n95% CI is based on Clopper-Pearson exact method for response rate."},{"outcome_type":"secondary","measure":"Vaccine Sub-study. Fold Increase of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Vaccine Sub-study Visit 2) at Vaccine Sub-study Visit 4","time_frame":"From vaccine sub-study visit 2 (baseline) to sub-study visit 4","description":"Geometric Mean Fold Increase From Baseline of Pneumococcal Antigens Measured at Visit 4.\r\nn was the number of participants with valid and determinate assay results for the specified serotype at the given visit.\r\nThe stated number of participants analyzed was the total number of participants. The actual number of participants analyzed for some serotypes varied, and is provided where it differed from the total number of participants.\r\nConfidence Intervals (CIs) were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations."},{"outcome_type":"secondary","measure":"Vaccine Sub-study. Fold Increase of Anti-influenza Antibody Levels to Each of the 3 Influenza Antigens Above Vaccination Baseline Values (Vaccine Sub-study Visit 2) at Vaccine Sub-study Visit 4","time_frame":"From vaccine sub-study visit 2 (baseline) to sub-study visit 4","description":"Geometric Mean Fold Increase From Baseline of Influenza Antigens Measured at Visit 4.\r\nn was the number of participants with valid and determinate assay results for the specified HAI strain at the given visit.\r\nConfidence Intervals (CIs) were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers."},{"outcome_type":"secondary","measure":"Vaccine Sub-study. Concentrations of Anti-pneumococcal Antibodies at Vaccine Sub-study Visit 3 and 4","time_frame":"From vaccine sub-study visit 2 (baseline) to sub-study visit 4","description":"Mean pneumococcal concentrations (ug/mL) at vaccine baseline (visit 2) and post-vaccination visits (visits 3 and 4) by serotype. The stated number of participants analyzed was the total number of participants in each group. The actual number of participants analyzed for each serotype varied, and is provided for each individually.\r\nug/mL=micrograms per milliliter"},{"outcome_type":"secondary","measure":"Vaccine Sub-study. Titers of Anti-influenza Antibodies at Vaccine Sub-study Visit 3 and 4","time_frame":"From vaccine sub-study visit 2 (baseline) to sub-study visit 4","description":"Mean influenza antibody titers at visits 3 and 4."}]}
{"nct_id":"NCT01677325","start_date":"2007-01-31","phase":"Phase 1","enrollment":40,"brief_title":"The Clinical Trail Of NAFLD Treated By Traditional Chinese Medicine","official_title":"The Clinical Trail Of NAFLD Treated By Traditional Chinese Medicine","primary_completion_date":"2007-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-01-31","last_update":"2012-09-05","description":"To investigate in subjects with non-alcoholic fatty liver disease the direct effects of a Chinese herb formula.","other_id":"2006-65","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  subjects with NAFLD(nonalcoholic fatty liver disease) (criteria of Society of\r\n             Hepatology, Chinese Medical Association, 2002.10),\r\n\r\n          -  aged 18-65\r\n\r\n          -  alcohol consumption less than 40g/week;\r\n\r\n          -  liver/spleen (L/S) ratio no more than 1 by CT scan.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  ALT more than twice the upper end of the normal range\r\n\r\n          -  viral hepatitis\r\n\r\n          -  total parenteral alimentation or secondary liver disease such as hepatocirrhosis,\r\n             autoimmune hepatitis, metabolic liver disease or drug induced liver disease\r\n\r\n          -  severe cardiovascular or renal dysfunction\r\n\r\n          -  Subjects with diabetes (fasting glucose more than or equal to 7.0mmol/L or\r\n             postprandial glucose more than or equal to 11.1mmol/L)\r\n\r\n          -  Subjects treated with statins\r\n      ","sponsor":"Fudan University","sponsor_type":"Other","conditions":"NAFLD( Non-alcoholic Fatty Liver Disease )","interventions":[{"intervention_type":"Drug","name":"Drug: Chinese herb (YiQiSanJu)","description":"Chinese herb formula:Huangqi,huanglian,yinchen,ect"}],"outcomes":[{"outcome_type":"other","measure":"electrocardiography","time_frame":"12 weeks","description":"automatic electrocardiograph machine"},{"outcome_type":"other","measure":"chest x-ray check","time_frame":"12 weeks","description":"diagnostic X-ray apparatus"},{"outcome_type":"primary","measure":"The CT ratio of liver/spleen","time_frame":"12 weeks","description":"CT imaging has been used to assess hepatic steatosis and has been validated in relation to liver biopsy .The ratio of liver to spleen (L/S ratio) for CT attenuation values is an index, with a L/S ratio<1 considered to represent fatty liver ."},{"outcome_type":"secondary","measure":"BMI(Body Mass Index )","time_frame":"12 weeks","description":"Body Mass Index,(weight/height^2)"},{"outcome_type":"secondary","measure":"liver function","time_frame":"12 weeks","description":"Liver function enzymes- alanine aminotransferase (ALT,U/L), aspartate aminotransferase (AST,U/L) and γ-glutamyltransferase (GGT,U/L) and total bilirubin (TBI,μmol/L), albumin/globin (A/G)(Automatic biochemical analyzer)"},{"outcome_type":"secondary","measure":"lipid profile","time_frame":"12 weeks","description":"Plasma lipids including triglyceride (TG,mmol/L), total cholesterol, low-density lipoprotein (LDL.mmol/L), high-density lipoprotein (HDL,mmol/L), apolipoprotein A (ApoA,mmol/L), apolipoprotein B (ApoB,mmol/L) and lipoprotein (a) (Lp(a),mmol/L). (Automatic biochemical analyzer)"},{"outcome_type":"secondary","measure":"NEFA(nonesterified fatty acid)","time_frame":"12 weeks","description":"Insulin sensitivity of lipolysis using NEFA concentrations(μmol/L).(Enzyme-linked immunosorbent assay)"},{"outcome_type":"secondary","measure":"HOMA index","time_frame":"12 weeks","description":"HOMA index(FBG*INSULIN/22.5)"},{"outcome_type":"secondary","measure":"adiponectin","time_frame":"12 weeks","description":"adiponectin(pg/ml,Enzyme-linked immunosorbent assay)"},{"outcome_type":"secondary","measure":"IL-6(interleukin 6)","time_frame":"12 weeks","description":"interleukin 6(pg/ml,Enzyme-linked immunosorbent assay)"},{"outcome_type":"secondary","measure":"hs-CRP (C-reactive protein)","time_frame":"12 weeks","description":"high sensitivity C-reactive protein(mg/L,Enzyme-linked immunosorbent assay)"},{"outcome_type":"secondary","measure":"TNFα( tumor necrosis factor-α)","time_frame":"12 weeks","description":"tumor necrosis factor-α(ng/L,Enzyme-linked immunosorbent assay)"},{"outcome_type":"secondary","measure":"leptin","time_frame":"12 weeks","description":"leptin(ng/ml,Enzyme-linked immunosorbent assay)"},{"outcome_type":"other","measure":"renal function","time_frame":"12 weeks","description":"creatinine(umol/L) ,usea nitrogen(mmol/l) and uric acid(umol/L)(Automatic biochemical analyzer)"},{"outcome_type":"other","measure":"Routine blood","time_frame":"12 weeks","description":"automatic blood analyzer. White Blood Cell Count:/L; Red Blood Cell Count:/L; Hemoglobin:g/L; Platelets:/L; neutrophilic granulocyte:％."},{"outcome_type":"other","measure":"Routine urine examination","time_frame":"12 weeks","description":"automatic urine analyzer. Color,odor,specific gravity,pH,Protein(g/L),Glucose(+-)."},{"outcome_type":"other","measure":"Routine stool examination","time_frame":"12 weeks","description":"automatic stool analyzer. Color, white blood cell(/Visual Fields), red blood cell(/Visual Fields), bacteria(/Visual Fields),occult blood(+-)"}]}
{"nct_id":"NCT00571961","start_date":"2007-01-31","phase":"N/A","enrollment":12,"brief_title":"Pharmacokinetic Interactions Between Buprenorphine and Kaletra (Lopinavir/Ritonavir)","official_title":"Pharmacokinetic Interactions Between Buprenorphine and Kaletra (Lopinavir/Ritonavir)","primary_completion_date":"2008-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-08-31","last_update":"2012-11-21","description":"The main purpose of this protocol is to study the effect of an HIV medication, Kaletra (lopinavir/ritonavir), on buprenorphine in non-HIV infected people who have been receiving the same dose of buprenorphine for at least 3 weeks. Study Hypothesis: Kaletra (lopinavir/ritonavir) will increase buprenorphine plasma levels without any significant clinical effect on the subject or need for dose adjustment.","other_id":"0511000791","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Chronic BUP users enrolled in BUP program, receiving BUP for at least 3 months and on\r\n             a stable BUP dose for at least 3 weeks.\r\n\r\n          -  Acceptable medical history, physical examination, 12 lead electrocardiogram, and\r\n             clinical laboratory evaluations consistent with BUP maintenance\r\n\r\n          -  Subjects who meet the criteria of opiate dependence, are enrolled in long-term BUP\r\n             maintenance therapy, and have been on a stable dose of BUP for at least 3 weeks.\r\n\r\n          -  Body weight >60 kg for males and >40 kg for females\r\n\r\n          -  Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive. BMI = weight (kg)/ [height (m)]2.\r\n\r\n          -  Male or females, ages 18 to 65 years.\r\n\r\n          -  Women of childbearing potential (WOCBP) must not be nursing, pregnant and on adequate\r\n             non-hormonal contraception to avoid pregnancy. WOCBP must have a negative serum or\r\n             urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within\r\n             24 hours prior to the start of Study Day 1.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Sex and Reproductive Status Exceptions\r\n\r\n          -  WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for\r\n             the entire study period and for up to 4 weeks before and after the study.\r\n\r\n          -  WOCBP using a prohibited contraceptive method (oral, injectable, or implantable\r\n             hormonal agents)\r\n\r\n          -  Women who are pregnant or breastfeeding\r\n\r\n          -  Women with a positive pregnancy test on enrollment or prior to study drug\r\n             administration.\r\n\r\n        Medical History and Concurrent Diseases\r\n\r\n          -  History or current evidence of any significant acute or chronic medical illness that,\r\n             within the investigator's discretion, would interfere with the conduct or\r\n             interpretation of the study.\r\n\r\n          -  History of nephrolithiasis\r\n\r\n          -  History of acute or chronic pancreatitis.\r\n\r\n          -  History of uncontrolled chronic medical illness which could adversely affect the\r\n             subject's adherence to study protocol or affect patient safety in the opinion of the\r\n             investigator\r\n\r\n          -  Use of any medication thought to significantly alter the metabolism of Kaletra,\r\n             Buprenorphine or naloxone.\r\n\r\n          -  History of any hemolytic disorders (including drug-induced hemolysis).\r\n\r\n          -  Proven or suspected acute hepatitis at the time of study entry.\r\n\r\n          -  Current or recent (within 3 months) gastrointestinal disease which would interfere\r\n             with the conduct or interpretation of the study.\r\n\r\n          -  Any major surgery within 4 weeks of enrollment. Minor surgical procedures requiring\r\n             local anesthesia are exceptions.\r\n\r\n          -  Any gastrointestinal surgery that could impact upon the absorption of study drug.\r\n\r\n          -  Donation of blood or plasma to a blood bank or in a clinical study (except a screening\r\n             visit) within 4 weeks of enrollment.\r\n\r\n          -  Blood transfusion within 4 weeks of enrollment.\r\n\r\n          -  Inability to tolerate oral medication.\r\n\r\n          -  Inability to tolerate venipuncture and/or absence of secure venous access.\r\n\r\n          -  Inability to refrain from smoking during in-patient period\r\n\r\n          -  Known or suspected HIV infection (subjects who are found to be positive upon screen\r\n             for HIV will be excluded).\r\n\r\n          -  Known active drug or alcohol abuse, which in the opinion of the investigator makes\r\n             study participation to completion unlikely.\r\n\r\n          -  Any other sound medical, psychiatric and/or social reason as determined by the\r\n             Investigator.\r\n\r\n        Physical and Laboratory Test Findings\r\n\r\n          -  Evidence of organ dysfunction or any clinically relevant deviations from the norms\r\n             observed in a buprenorphine treated population in physical examination, vital signs,\r\n             ECG or clinical laboratory determinations.\r\n\r\n          -  Ingestion of alcohol within 24 hours prior to the dose of study medication\r\n\r\n          -  Positive breathalyzer alcohol test, or positive urine screen for barbiturates,\r\n             benzodiazepines, amphetamines or opiates other than buprenorphine.\r\n\r\n          -  Positive blood screen for HIV antibody.\r\n\r\n          -  QTc interval >450 msec for males or >470 msec for females.\r\n\r\n          -  Second or third-degree AV block.\r\n\r\n          -  Creatinine clearance(as estimated by method of Cockcroft and Gault) less than 80\r\n             mL/min.\r\n\r\n          -  CLcr=0.85(females only)x(140-age)x weight(kg)\r\n\r\n          -  serum creatinine(mg/dL)x 72\r\n\r\n          -  Subjects with bilirubin >2 mg/dL, serum albumin <2.5 g/dL and ascites, AST and ALT >3\r\n             times ULN, hemoglobin <9 g/dL, and platelet count <75,000/mm3.\r\n\r\n          -  Positive serum or urine for HCG.\r\n      ","sponsor":"Yale University","sponsor_type":"Other","conditions":"HIV Infections","interventions":[{"intervention_type":"Drug","name":"Drug: Kaletra (lopinavir/ritonavir)","description":"4 tablets, once a day (800 mg/dose) on Days 2 through 14 of this study"},{"intervention_type":"Drug","name":"Drug: buprenorphine","description":"Buprenorphine will be obtained through prescription at the subject's drug treatment program."},{"intervention_type":"Other","name":"Other: Clinical evaluations/Blood draws","description":"Physical examinations, vital sign measurements, 12-lead electrocardiogram (ECG), clinical laboratory evaluations (blood chemistry and blood counts), PK blood draws."}],"outcomes":[{"outcome_type":"primary","measure":"Buprenorphine Area Under the Curve With LPV/r (ng/mL*hr)","time_frame":"15 days","description":"Pharmacokinetic parameters were determined by use of non compartmental methods. The area under the plasma concentration versus time curve was determined by use of the trapezoidal rule and measured over a 24-hr time period."}]}
{"nct_id":"NCT00425490","start_date":"2007-01-31","phase":"Phase 3","enrollment":30,"brief_title":"Effect of Januvia on Beta Cell Function in Patients With Diabetes Mellitus","official_title":"Phase III Study on the Effect of Sitagliptin on Maximal Beta Cell Stimulation","primary_completion_date":"2009-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-07-31","last_update":"2009-09-23","description":"The study is designed to investigate the effect of 18 weeks treatment with Sitagliptin 100 mg/day on the insulin secretion capacity of beta cells. Patients who meet the study enrollment criteria will undergo 2 experiments (see description below); a graded hyperglycemic technique and a meal test, prior to randomization and after a 12-wk double-blind study period. The treatment effect will shed light on the magnitude of the beta cell capacity to increase its mass and function.","other_id":"SHEBA-06-4373-OC-CTIL","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion criteria:\r\n\r\n          -  Patient has T2DM diagnosed within the past 5 years\r\n\r\n          -  Patient is >18 and <65 years of age\r\n\r\n          -  Patient is not pregnant, breast feeding and unlikely to conceive\r\n\r\n          -  Patient understands the study procedures, and agrees to participate in the study by\r\n             giving written informed consent\r\n\r\n          -  Patient meets one of the following criteria:\r\n\r\n               1. Patient is currently not on an AHA and has a Visit 1 HbA1c 6.5% and 10%. OR\r\n\r\n               2. Patient is currently on AHA monotherapy or low dose (i.e. 50% maximum labeled\r\n                  dose of each agent) oral combination therapy and has a Screening/Visit 1 HbA1c\r\n                  6.5% and 9.5%.\r\n\r\n          -  At visit 2, patient has a HbA1c of 6.5% and 10%\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patient has type 1 diabetes mellitus\r\n\r\n          -  Patient required insulin therapy within 12 weeks of Visit 1. Note: patients who\r\n             received a brief period of insulin treatment (e.g., several days during a\r\n             hospitalization) and who are no longer requiring insulin treatment may participate\r\n\r\n          -  Patient is currently or within 12 weeks of Visit 1 taking a TZD agent as monotherapy\r\n             or in combination\r\n\r\n          -  Patient is currently or within 12 weeks of Visit 1 taking Byetta.\r\n\r\n          -  Patient is on corticosteroids\r\n\r\n          -  Patient has a history of malignancy 5 years prior to signing informed consent, or >5\r\n             years without documentation of remission/cure Exception: Adequately treated basal cell\r\n             or squamous cell skin cancer or in situ cervical cancer. Melanoma, leukemia, lymphoma\r\n             and myeloproliferative disorders of any duration are excluded -Patient is on\r\n             chemotherapy\r\n\r\n          -  Patient received another investigational drug in the last 12 weeks.\r\n\r\n          -  Patients with concomitant liver disease and or AST > 3 fold upper limit of normal\r\n\r\n          -  Patients with kidney disease or CR>1.4 mg/dl\r\n\r\n          -  Patients with anemia ( Hb <11 gr in male 10 gr in female)\r\n\r\n          -  Patient with active vascular disease (coronary, peripheral or cerebrovascular)\r\n\r\n          -  Patient has poorly controlled hypertension defined as systolic blood pressure >160 mm\r\n             Hg or diastolic >95 mm Hg\r\n\r\n          -  Proliferative retinopathy\r\n      ","sponsor":"Sheba Medical Center","sponsor_type":"Other","conditions":"Diabetes Mellitus Type 2","interventions":[{"intervention_type":"Drug","name":"Drug: sitagliptin"}],"outcomes":[{"outcome_type":"primary","measure":"FPG,"},{"outcome_type":"primary","measure":"HbA1c,"},{"outcome_type":"primary","measure":"β-cell Function Parameters(Φs, Φd, Φb, Φ, Φob, T), Insulin Secretion Rate (determined from C-peptide deconvolution), 1st and 2nd phase insulin secretion, Insulin response after arginine injection, Insulin sensitivity index, glucose, insulin,"},{"outcome_type":"primary","measure":"C-peptide total and incremental area under the curve."}]}
{"nct_id":"NCT00596570","start_date":"2007-01-31","enrollment":996,"brief_title":"Management of Patients With Atrial Fibrillation Undergoing Coronary Artery Stenting","official_title":"Management of Patients With Atrial Fibrillation Undergoing Coronary Artery Stenting: A Multicenter, Prospective Registry","study_type":"Observational","rec_status":"Completed","completion_date":"2010-02-28","last_update":"2010-06-30","description":"Treatment of patients suffering from atrial fibrillation pose problems when percutaneous coronary intervention with stent implantation (PCI-S) is performed. In the absence of solid evidence-based data, no definite recommendations for the management of this patient subset are currently given in the guidelines on percutaneous coronary intervention issued by the most prominent Cardiology Associations. The management of the antithrombotic treatment before invasive cardiac procedures is also incompletely defined. In this study we aim to determine in patients with atrial fibrillation undergoing PCI-S: 1. the contemporary antithrombotic management; 2. the relative safety and efficacy of the various post-PCI antithrombotic regimens; 3. the safety and efficacy of drug-eluting stents (DES), bare-metal stents (BMS), and bioactive stents (BAS); 4. the safety of various periprocedural antithrombotic strategies including glycoprotein IIb/IIIa inhibitors and bivalirudin; 5. safety and efficacy of radial vs femoral approach.","other_id":"12007","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","population":"Patients with atrial fibrillation undergoing PCI-S.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with atrial fibrillation who undergo PCI.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Because of the observational design, no exclusion criteria are provided.\r\n      ","sponsor":"University of Turku","sponsor_type":"Other","conditions":"Atrial Fibrillation|Oral Anticoagulation|Percutaneous Coronary Intervention","interventions":[{"intervention_type":"Procedure","name":"Procedure: PCI","description":"Percutaneous coronary interventiom"}],"outcomes":[{"outcome_type":"primary","measure":"major hemorrhagic and thrombotic/thromboembolic complications including cardiac death","time_frame":"one year"}]}
{"nct_id":"NCT00753610","start_date":"2007-01-31","enrollment":30,"brief_title":"Endothelial Progenitor Cells in Cervical Cancer Patients Receiving Chemoradiation","official_title":"Effect of Concurrent Chemoradiation on Circulating Endothelial Progenitor Cells in Cervical Cancer","primary_completion_date":"2018-12-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2019-12-31","last_update":"2018-08-17","description":"Invasive carcinoma of the uterine cervix remains the most common invasive cancer in women in many countries. Concurrent chemoradiotherapy (CCRT) is now recommended as a standard treatment for locally advanced and high-risk cervical carcinoma. However, CCRT achieves a better control of cervical cancer accompanied by greater morbidity. To avoid unnecessary over-treatment, the optimization of CCRT is of critical importance. Herein, the development of a surrogate marker for monitoring treatment efficacy as well as toxicity is pivotal to optimize CCRT. Circulating endothelial progenitor cells (EPC), derived from bone marrow, can be used as a marker for optimizing and monitoring the anti-angiogenesis therapy including angiogenesis inhibitors and metronomic chemotherapy. Preclinical models indicated that the source of apoptotic circulating endothelial cells (CEC) was most likely the tumor vasculature. In breast cancer patients, apoptotic CEC were demonstrated to be a surrogate marker for efficacy of metronomic therapy. In this grant, we intent to monitor the levels of circulating EPC/CEC in locally advanced cervical cancer patients before, during and after CCRT.","other_id":"MMH-I-S-354","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"Female","minimum_age":20,"maximum_age":80,"population":"Cervical cancer stage Ib - IVA","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Receiving chemoradiation\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Stage IVB\r\n      ","sponsor":"Mackay Memorial Hospital","sponsor_type":"Other","conditions":"Cervical Cancer","interventions":{},"outcomes":{}}
{"nct_id":"NCT00772174","start_date":"2007-01-31","phase":"Phase 3","enrollment":418,"brief_title":"Efficacy and Safety Study of Pioglitazone Combined With Metformin on Metabolic Syndrome in Subjects With Type 2 Diabetes","official_title":"Double-blind, Randomized, Multicenter, Parallel-Group Study to Evaluate the Effects of Pioglitazone on Metabolic Syndrome in Patients With Type 2 Diabetes Treated With Metformin","primary_completion_date":"2008-02-29","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-02-29","last_update":"2010-07-05","description":"The purpose of this study was to determine the efficacy of pioglitazone taken with metformin on high-density lipoprotein cholesterol in subjects with Type 2 Diabetes.","other_id":"IT-PIO-108","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":35,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosis of Type 2 Diabetes Mellitus.\r\n\r\n          -  Has glycosylated hemoglobin levels between 6.0% and 8.0%.\r\n\r\n          -  Treatment with metformin (2,000 to 3,000 mg daily) for at least 3 months.\r\n\r\n          -  Has reduced high-density lipoprotein cholesterol levels less than 40 mg/dl in males\r\n             and less than 50 mg/dl in females, irrespective of treatment with statins.\r\n\r\n          -  Has central obesity defined as a waist circumference greater than or equal to 94 cm\r\n             for men and greater than or equal to 80 cm for females.\r\n\r\n          -  Females of childbearing potential who are sexually active must agree to use adequate\r\n             contraception, and can neither be pregnant nor lactating from Screening throughout the\r\n             duration of the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Has a diagnosis of Type 1 Diabetes Mellitus.\r\n\r\n          -  Required to take or intends to continue taking any disallowed medication, any\r\n             prescription medication, herbal treatment or over-the counter medication that may\r\n             interfere with evaluation of the study medication, including:\r\n\r\n               -  other oral antidiabetic drugs than metformin or with insulin in the 3 months\r\n                  preceding study entry.\r\n\r\n               -  Fibrates\r\n\r\n               -  Rifampicin\r\n\r\n          -  Has any disease with malabsorption.\r\n\r\n          -  Has acute or chronic pancreatitis.\r\n\r\n          -  Has familial polyposis coli.\r\n\r\n          -  Has a medical history of myocardial infarction, transient ischemic attacks or stroke\r\n             in the past 6 months.\r\n\r\n          -  Has heart failure as defined by the New York Heart Association classification I-IV.\r\n\r\n          -  Has significant liver impairment, with an alanine aminotransferase level greater than\r\n             2.5 the upper limit of normal range.\r\n\r\n          -  Has significant renal impairment, with a serum creatinine level greater than 1.5 mg/dl\r\n             for men and greater than 1.2 mg/dl for women.\r\n\r\n          -  Has anemia of any etiology (defined as hemoglobin levels less than 10.5 g/dL) or any\r\n             other hematologic disease.\r\n\r\n          -  Has a diagnosis or suspicion of neoplastic disease.\r\n\r\n          -  History of chronic alcohol or drug abuse.\r\n\r\n          -  Known allergy, sensitivity or intolerance to the study drugs and their formulation\r\n             ingredients.\r\n\r\n          -  Participation in another trial in the 3 months preceding study entry.\r\n      ","sponsor":"Takeda","sponsor_type":"Industry","conditions":"Diabetes Mellitus","interventions":[{"intervention_type":"Drug","name":"Drug: Pioglitazone and Metformin","description":"Pioglitazone 15 mg, tablets, orally, two-times daily and metformin stable dose, orally, three-times daily for 4 weeks; then increased to pioglitazone 15 mg, tablets, orally, three-times daily and metformin stable dose, orally, three-times daily for up to 20 weeks."},{"intervention_type":"Drug","name":"Drug: Metformin","description":"Pioglitazone placebo-matching tablets, orally, two-times daily and metformin stable dose, orally, three-times daily for 4 weeks; then increased to pioglitazone placebo-matching tablets, orally, three-times daily and metformin stable dose, orally, three-times daily for up to 20 weeks."}],"outcomes":[{"outcome_type":"secondary","measure":"The change from Baseline in Individual Metabolic Parameters (insulin sensitivity and beta-cell function, inflammatory cytokines, adipokines, endothelial functionality).","time_frame":"Weeks: 8 and 24."},{"outcome_type":"secondary","measure":"Adverse Events.","time_frame":"At all Visits."},{"outcome_type":"secondary","measure":"The change from Baseline in Laboratory Parameters (hematology, chemistry and urinalysis).","time_frame":"Weeks: 8 and 24."},{"outcome_type":"primary","measure":"Increase in High-Density Lipoprotein cholesterol levels.","time_frame":"Final Visit."},{"outcome_type":"secondary","measure":"The change from Baseline in Metabolic Syndrome, as defined by the International Diabetes Federation (aggregate waist circumference, fasting plasma glucose, triglycerides and high-density lipoprotein cholesterol).","time_frame":"Weeks: 8 and 24."},{"outcome_type":"secondary","measure":"The change from Baseline in Metabolic Syndrome, as defined by the International Diabetes Federation (blood pressure).","time_frame":"At all Visits."}]}
{"nct_id":"NCT00432952","start_date":"2007-01-31","phase":"N/A","enrollment":6,"brief_title":"Acute Single Meal Effects of Trout on Cardiovascular Risk Markers and Plasma Proteome","primary_completion_date":"2007-03-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2009-01-31","last_update":"2008-08-13","description":"The acute effects of farmed rainbow trout, fed by various feeds versus a control meal with poultry meat on cardiovascular risk markers and plasma protein expression are investigated. The hypotheses of the study are that if the feed are changed from a marine origin to primarily a vegetable origin the content of long chain n-3 poly unsaturated fatty acids (n-3 PUFA) will decrease in the meat and thus possibly result in a decreased effect on health. Furthermore, the feed of the trouts are also expected to give rise to differences in the human plasma protein profile and fatty acid composition after consumption, which could be associated with physiological effects.","other_id":"M186","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"Male","minimum_age":40,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Non regular smokers\r\n\r\n          -  Body Mass Index (18.5-30 kg/m2)\r\n\r\n          -  Able to eat fish\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Exercise >10 h/week\r\n\r\n          -  Chronical diseases (eg. cardiovascular and diabetes)\r\n\r\n          -  Regular medication\r\n\r\n          -  Fish oil supplementation\r\n\r\n          -  Blood donation 2 month prior or during participation\r\n\r\n          -  Above maximum recommended alcohol intake\r\n\r\n          -  Blood pressure >160/100 mm Hg\r\n      ","sponsor":"University of Copenhagen","sponsor_type":"Other","conditions":"Cardiovascular Diseases|Metabolic Syndrome","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Intake of rainbow trout from different feeding conditions versus a control poultry meal"}],"outcomes":[{"outcome_type":"primary","measure":"plasma protein expression"},{"outcome_type":"primary","measure":"Blood Pressure"},{"outcome_type":"primary","measure":"Pulse Wave Analysis"},{"outcome_type":"primary","measure":"Pulse wave Velocity"},{"outcome_type":"secondary","measure":"Plasma Triglycerides"}]}
{"nct_id":"NCT00417846","start_date":"2007-01-31","enrollment":98,"brief_title":"Age-related Macular Degeneration: Detection of Onset of New Choroidal Neovascularization (AMD DOC Study)","official_title":"Age-related Macular Degeneration: Detection of Onset of New Choroidal Neovascularization (AMD DOC Study)","primary_completion_date":"2009-08-31","study_type":"Observational","rec_status":"Completed","completion_date":"2009-08-31","last_update":"2009-10-05","description":"The purpose of this study is to determine the sensitivity of the optical coherence tomography (OCT) test in detecting neovascular AMD in eyes at high risk for CNV development. In order to test this hypothesis, we are conducting a multi-center clinical study at four participating clinical centers. A total of 227 participants will be enrolled. Participants will be followed-up for a period of two years, or until CNV develops in the study eye for which treatment is recommended, to determine the occurrence of CNV. The fundamental design principles of the study are simplicity and parsimony.","other_id":"NA_00006147","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":50,"population":"Participants will have neovascular AMD in the fellow eye and non-neovascular AMD in the\r\n        candidate study eye to be eligible for this study. Additional inclusion and exclusion\r\n        criteria are listed below.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Ability to provide written informed consent and comply with study assessments for the\r\n             full duration of the study\r\n\r\n          -  Age 50 years or greater\r\n\r\n          -  Best corrected visual acuity letter score = 65 or greater (approximate Snellen\r\n             equivalent of 20/50 or better in the candidate study eye)\r\n\r\n          -  Neovascular AMD in the fellow eye and no CNV in the candidate study eye (absence of\r\n             CNV confirmed by FA which will be graded in a masked fashion by the AMD DOC Study\r\n             Reading Center)\r\n\r\n          -  Candidate study eye must have evidence of at least one large druse ( 125m) and focal\r\n             hyperpigmentation within 3600m of the fovea and visible on color fundus photography,\r\n             red-free photograph, or fluorescein angiography\r\n\r\n          -  Participant must have media clear enough in the candidate study eye to permit fundus\r\n             photography, fluorescein angiography, and optical coherence tomography and absence of\r\n             any fluorescein allergies\r\n\r\n          -  Results of the baseline PHP and supervised Amsler grid will not affect eligibility of\r\n             the participant. Subjects can be eligible for further follow-up even if they have\r\n             positive PHP and Amsler grid\r\n\r\n          -  Eligible participants who have a positive PHP or supervised Amsler grid for that eye\r\n             at the initial screening visit should have a second PHP or supervised Amsler grid\r\n             screening visit within 2 weeks in order to repeat the PHP or Amsler test or the\r\n             participant may repeat the PHP or Amsler grid that day before pupillary dilation.\r\n             Participants with a 2nd positive PHP or supervised Amsler grid are still eligible for\r\n             further follow-up\r\n\r\n          -  All tests (supervised Amsler grid, PHP, OCT, FA) must be performed within 2 weeks of\r\n             each other\r\n\r\n          -  Participants with non-foveal geographic atrophy in the candidate study eye are still\r\n             eligible for enrollment in the study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Known allergy to fluorescein angiography or allergic reaction during screening\r\n\r\n          -  Advanced AMD with CNV in both eyes confirmed on FA graded by the AMD DOC Study Reading\r\n             Center\r\n\r\n          -  Foveal geographic atrophy in the study eye\r\n\r\n          -  Positive OCT test for the candidate study eye, as read by the AMD DOC Study Reading\r\n             Center, for subretinal fluid, intraretinal edema, or retinal thickening that falls\r\n             within the top 1% of the normative data base for the Stratus OCT\r\n\r\n          -  Significant media opacity that precludes reasonable quality retinal imaging including\r\n             color fundus photographs, fluorescein angiography, or OCT in the candidate study eye\r\n             to assess the presence of CNV\r\n\r\n          -  Evidence of macular disease (e.g., pattern dystrophy, diabetic macular edema,\r\n             vitreomacular traction) other than AMD in the study eye\r\n\r\n          -  Previous surgical or laser treatment to the macula of the study eye\r\n\r\n          -  Diabetic retinopathy\r\n      ","sponsor":"Johns Hopkins University","sponsor_type":"Other","conditions":"Maculopathy, Age-Related|Choroidal Neovascularization","interventions":{},"outcomes":{}}
{"nct_id":"NCT01656382","start_date":"2007-01-31","phase":"Phase 4","enrollment":0,"brief_title":"Safety, Efficacy, and Pharmacokinetics of Amphotericin B Lipid Complex","official_title":"Safety, Efficacy, and Pharmacokinetics of Amphotericin B Lipid Complex at 10 mg/kg/d for 7 Days or 5.0 mg/kg/d for 14 Days as Induction Therapy for Disseminated Cryptococcosis in Patients With HIV","primary_completion_date":"2010-01-31","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2010-01-31","last_update":"2021-02-17","description":"The purpose of this study is to determine if initial therapy with ABLC at 10/mg/kg/d for 7 days are at least effective as ABLC at 5.0 mg/kg/d X 14 days as induction treatment of patients with disseminated cryptococcosis and HIV.","other_id":"2006-273","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Diagnosis of cryptococcal meningitis based on any of the following:\r\n\r\n               -  Cerebrospinal fluid positive for C. neoformans\r\n\r\n               -  Cerebrospinal fluid positive for cryptococcal antigen\r\n\r\n          2. Male or female 18 years of age or older.\r\n\r\n          3. All female patients must be non-lactating and have a negative serum pregnancy test at\r\n             time of screening. Females of childbearing potential must be using a medically\r\n             acceptable method of contraception and agree to continue its use during the study\r\n             period, or must be one year postmenopausal, or have been surgically sterilized.\r\n\r\n          4. Willing and able to give a signed informed consent, or have a legally authorized\r\n             representative who is willing or able to give consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. A history or evidence of hypersensitivity to AmB or any of its metabolites.\r\n\r\n          2. A history or evidence of any psychiatric, neurological metabolic, or other chronic\r\n             condition, which in the investigator's opinion, would make the patient unsuitable for\r\n             the study or interfere with the evaluation of ABLC.\r\n\r\n          3. Inability to comply with the procedures of the study.\r\n\r\n          4. Patients who have received greater than 72 hours of therapy with another systemic\r\n             antifungal agent within 2 weeks prior to enrollment\r\n\r\n          5. Patients with any of the following abnormal laboratory values\r\n\r\n               -  Baseline creatinine clearance of less than 50.\r\n\r\n               -  Bilirubin of greater than 5 times the upper limit of normal\r\n\r\n               -  AST or ALT of greater than 10 times the upper limit of normal\r\n\r\n          6. Life expectancy of less than 72 hours\r\n      ","sponsor":"Medstar Health Research Institute","sponsor_type":"Other","conditions":"Invasive Cryptococcosis","interventions":[{"intervention_type":"Drug","name":"Drug: ABLC"}],"outcomes":[{"outcome_type":"primary","measure":"Survival"},{"outcome_type":"primary","measure":"Time to Sterilization of CSF"},{"outcome_type":"secondary","measure":"Infusion related and renal toxicity"}]}
{"nct_id":"NCT00431132","start_date":"2007-01-31","phase":"Phase 3","enrollment":336,"brief_title":"Endometrial Safety of a Low Dose of Vagifem in Postmenopausal Women With Atrophic Vaginitis","official_title":"A 12 Month, Open-label, Multi-center Trial to Investigate the Endometrial Safety of Vagifem Low Dose (10ug 17beta-estradiol Vaginal Tablet) in Postmenopausal Women With Atrophic Vaginitis Symptoms","primary_completion_date":"2008-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-11-30","last_update":"2017-03-15","description":"This trial is conducted in Europe. The purpose of this study is to evaluate endometrial safety of intravaginal estradiol (Vagifem) in healthy postmenopausal women having atropic vaginitis.","other_id":"VAG-1748","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Postmenopausal women whose last menstruation was at least two years prior to the time\r\n             of screening\r\n\r\n          -  At least 1 urogenital symptom (vaginal dryness, vaginal and/or vulvar\r\n             irritation/itching, vaginal soreness, dysuria, dyspareunia and vaginal bleeding\r\n             associated with sexual activity\r\n\r\n          -  Generally healthy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Exposure to exogenous sex steroid hormones (estrogen and/or progestin hormone\r\n             replacement therapy) within past 3 months\r\n      ","sponsor":"Novo Nordisk A/S","sponsor_type":"Industry","conditions":"Menopause|Postmenopausal Vaginal Atrophy","interventions":[{"intervention_type":"Drug","name":"Drug: estradiol, 10 mcg","description":"Tablets, administered intravaginally twice weekly"}],"outcomes":[{"outcome_type":"secondary","measure":"Transvaginal Ultrasound: Endometrial Thickness","time_frame":"Week 0, week 52","description":"Transvaginal ultrasounds were performed at Baseline (Week 0) and Week 52, or at the time of withdrawal in the case of a subject's premature discontinuation. Endometrial thickness, measured (double layer) in mm, were lesser than 4 mm for entry into the trial."},{"outcome_type":"primary","measure":"Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies","time_frame":"Week 52","description":"The endometrial hyperplasia rate was calculated based on the number of patients with endometrial hyperplasia/endometrial carcinoma divided by the total number of subjects with interpretable biopsies at Week 52."}]}
{"nct_id":"NCT00458679","start_date":"2006-12-31","phase":"Phase 1","enrollment":6,"brief_title":"Treatment of B-Chronic Lymphocytic Leukemia (B-CLL) With Autologous CD40 Ligand and IL-2-Expressing Tumor Cells","official_title":"Prolonged Immunization With Autologous CD40 Ligand and IL-2-Expressing Tumor Cells for Treatment of B-Chronic Lymphocytic Leukemia (B-CLL)","primary_completion_date":"2008-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-08-31","last_update":"2014-02-03","description":"We would like patients to be in a research study to determine the safety and effectiveness of special cells that may make their own immune system fight their cancer. To do this, we will put a special gene into cancer cells that have been taken from the patients body. This will be done in the laboratory. This gene will make the cells produce interleukin 2 (IL-2), which is a natural substance that may help their immune system kill cancer cells. Additionally, we will stimulate the cancer cells with normal embryonic fibroblasts (cells that develop into normal connective tissues in the body) so that they will make another natural protein called CD40 ligand (CD40L). Studies of cancers in animals suggest IL-2 performs better when mixed with CD40L. Some of these cells will then be put back into the patients body with the goal that they will act like a vaccine and stimulate their immune system to attack the CLL cells. Studies of cancers in animals and in cancer cells that are grown in laboratories suggest that combining substances like IL-2 and CD40L with cancer cells help the body recognize and kill cancer cells. We have already conducted a study similar to this in patients with CLL. In that study, the subjects received about three months of injections (shots). In those subjects we saw some changes in the subject's immune system that might indicate that the modified cells were helping their immune system fight the cancer. However, in most of the subjects this change in the immune system went away after the injections were stopped. In this study we want to see if we can make the change in the immune system last longer by giving more injections over a longer period of time. We hope that this might produce a better response directed at the CLL cells. We will also be looking at the effect on cells called cancer stem cells which grow into the CLL cells we see in the blood. Specifically, this study will allow subjects to receive the injections for up to one year.","other_id":"19747-PRIMAL","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        INCLUSION CRITERIA:\r\n\r\n        Eligibility for blast collection:\r\n\r\n          -  Patients are eligible for administration of their vaccine if they present with B-CLL\r\n             (not in Richter's transformation) with measurable disease.\r\n\r\n          -  Procurement consent signed and faxed to Research Coordinator\r\n\r\n          -  Eligibility for Vaccine Administration (protocol entry)\r\n\r\n          -  Manipulated B-CLL cells available (at least 12 injections)\r\n\r\n          -  Patients are eligible for administration of their vaccine if they present with B-CLL\r\n             (not in Richter's transformation) with measurable disease\r\n\r\n          -  Patients must have a life expectancy of at least 10 weeks.\r\n\r\n          -  Patients must have ECOG performance status of 0-2 as below:\r\n\r\n               -  Grade 0: Up and about, no restriction\r\n\r\n               -  Grade 1: Ambulatory, no strenuous activity\r\n\r\n               -  Grade 2: Ambulatory, capable of self-care appropriate for age. Up and about > 50%\r\n                  of time, but unable to carry out any physical activities or attend school.\r\n\r\n               -  Grade 3: Limited self-care only. Up and about < 50% of time\r\n\r\n               -  Grade 4: Disabled, no self-care. Bedridden or confined to chair\r\n\r\n          -  Patients must have recovered from the toxic effects of all prior chemotherapy before\r\n             entering this study, and must have an absolute neutrophil count (ANC) of greater than\r\n             or equal to 500/uL, absolute lymphocyte count (ALC) greater than or equal to 200/uL,\r\n             hemoglobin greater than or equal to 8 g/dL and platelet count greater than or equal to\r\n             50,000/uL.\r\n\r\n          -  Patients must be willing to practice appropriate birth control methods during the\r\n             study and for 3 months after the study is concluded. This includes total abstinence,\r\n             oral contraceptives, an intrauterine device, contraceptive implants under the skin,\r\n             contraceptive injections (Depo-Provera [Registered]). Contraceptive foam with a condom\r\n             is allowed. The male partner should use a condom.\r\n\r\n          -  Patients must have adequate liver function (total bilirubin less than or equal to 1.5\r\n             mg/dl, SGOT less than or equal to 3 times normal, normal prothrombin time).\r\n\r\n          -  Patients must have adequate renal function (creatinine less than 3 times normal for\r\n             age or creatinine clearance greater than 80 mg/min/1.73m^2).\r\n\r\n          -  Patients must sign an informed consent indicating that they are aware this is a\r\n             research study and have been told of its possible benefits and toxic side-effects.\r\n             Patients will be given a copy of the consent form.\r\n\r\n          -  Patient must not have received treatment with other investigational agents within the\r\n             last 4 weeks.\r\n\r\n        EXCLUSION CRITERIA:\r\n\r\n          -  Infected at time of protocol entry, or receiving antibiotics (other than prophylactic\r\n             trimethoprim sulfamethoxazole).\r\n\r\n          -  HIV positive\r\n\r\n          -  Pregnant or lactating\r\n\r\n          -  Suffering from an autoimmune disease (including active graft-versus-host disease-GvHD,\r\n             refractory immune thrombocytopenia-ITP or refractory autoimmune hemolytic anemia-AIHA)\r\n\r\n          -  Receiving immunosuppressive drugs\r\n\r\n          -  Patients without adequate cardiac function (congestive heart failure, significant\r\n             arrhythmia)\r\n      ","sponsor":"Baylor College of Medicine","sponsor_type":"Other","conditions":"Chronic Lymphocytic Leukemia (CLL)","interventions":[{"intervention_type":"Biological","name":"Biological: CD40 LIGAND AND IL-2-EXPRESSING TUMOR CELLS VACCINE","description":"Patients will receive a fixed dose (2 x 10^7) of IL-2 secreting B-cells together with (2 x 10^7)hCD40L expressing B-cells. They will receive 18 deltoid injections over 52 weeks."}],"outcomes":[{"outcome_type":"primary","measure":"To measure adverse events of patients receiving prolonged immunization with an autologous B-CLL vaccine expressing CD40L and IL2","time_frame":"10 weeks"},{"outcome_type":"secondary","measure":"Measurement of MHC-restricted or unrestricted anti-tumor immune responses","time_frame":"2 years"}]}
{"nct_id":"NCT00606567","start_date":"2006-12-31","phase":"N/A","enrollment":151,"brief_title":"A Randomized Trial of Remote Monitoring of Implantable Cardioverter Defibrillators Versus Quarterly Device Interrogations in Clinic","official_title":"A Randomized Trial of Remote Monitoring of Implantable Cardioverter Defibrillators Versus Quarterly Device Interrogations in Clinic","primary_completion_date":"2008-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-05-31","last_update":"2014-07-14","description":"The purpose of this study is to determine if remote monitoring of implantable cardioverter defibrillators (ICD), compared with quarterly device interrogations in clinic, will improve patients' outcomes and satisfaction and will reduce health care costs.","other_id":"Pro00010068","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18 years of age or older\r\n\r\n          -  Must have an ICD with or without CRT for an approved indication\r\n\r\n          -  Must be planning to have their devices followed-up at Duke\r\n\r\n          -  Must have a telephone (land line)\r\n\r\n          -  Willing and able to provide informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  18 years of age or younger\r\n\r\n          -  No telephone with land line\r\n\r\n          -  Unable to provide informed consent.\r\n      ","sponsor":"Duke University","sponsor_type":"Other","conditions":"Tachycardia, Ventricular|Ventricular Fibrillation","interventions":[{"intervention_type":"Other","name":"Other: Methods for monitoring patients with ICD's","description":"Intervention comparing 2 different methods of monitoring patients with ICDs; at home monitoring vs. quarterly monitoring in the clinic."}],"outcomes":[{"outcome_type":"primary","measure":"Re-hospitalization and ED visits for cardiac causes, unscheduled clinic visits for device-related issues, medications, patient logs, patients' level of satisfaction with their device care at baseline, 6 months, and 12 months.","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Health-related quality of life at baseline, 6 months, and 12 months. Health utilization costs incurred during the study period.","time_frame":"12 months"}]}
{"nct_id":"NCT00606476","start_date":"2006-12-31","phase":"Phase 2","enrollment":194,"brief_title":"AAB-001 (Bapineuzumab) Open-Label, Long-Term Extension Study in Patients With Mild to Moderate Alzheimer's Disease","official_title":"A Phase II, Multicenter, Open-Label, Long-Term Treatment Study to Determine the Safety, Tolerability, and Efficacy of Bapineuzumab (AAB-001) in Patients With Alzheimer's Disease Who Participated in Study AAB-001-201 or AAB-001-102","primary_completion_date":"2012-09-30","study_type":"Interventional","rec_status":"Terminated","completion_date":"2012-09-30","last_update":"2013-11-25","description":"This is a multicenter, open-label, long-term extension study in male and female patients with mild to moderate Alzheimer's Disease (AD) who must have completed one of the following studies: AAB-001-201 or AAB-001-102. All patients enrolled in Study AAB-001-251 will receive infusions of AAB-001 (bapineuzumab), including patients randomized to placebo in Study 201 and 102. Approximately 30 study sites in the US will be involved. Each patient's participation may vary from 3 months up to 84 months depending on the date of enrollment in this study. AAB-001 (bapineuzumab) is a humanized monoclonal antibody, which binds to and potentially clears beta amyloid peptide, and is designed to provide antibodies to beta amyloid directly to the patient.","other_id":"AAB-001-251","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        A subject must meet ALL of the following criteria to be considered for enrollment into this\r\n        study:\r\n\r\n          1. Signed and dated written informed consent obtained from the subject and/or the\r\n             subject's caregiver in accordance with the local regulations.\r\n\r\n          2. Subjects must have completed Study 201 Visit 22 (Week 78), or Study 102 Visit 11 (Week\r\n             16).\r\n\r\n          3. Magnetic resonance imaging scan of sufficient quality for the Radiologist to evaluate\r\n             subject safety from Study 201 Visit 21 (Week 71), or Study 251 Screening Visit for\r\n             subjects from Study 102.\r\n\r\n          4. Lives at home with appropriate caregiver capable of accompanying the subject on all\r\n             clinic visits, or community dwelling with caregiver capable of accompanying the\r\n             subject on all clinic visits and visiting with the subject approximately five times\r\n             per week for the duration of the study.\r\n\r\n          5. In the opinion of the investigator, the subject and the caregiver will be compliant.\r\n\r\n        Exclusion Criteria:\r\n\r\n        ANY one of the following will exclude a subject from being enrolled into the study:\r\n\r\n          1. Significant neurological disease other than AD that may affect cognition.\r\n\r\n          2. Screening visit brain MRI scan (ie, Study 201 Visit 21 (Week 71), or for Study 102,\r\n             the Study 251 Screening Visit) indicative of any other significant abnormality\r\n             including but not limited to multiple microhemorrhages or evidence of a single prior\r\n             hemorrhage >1 cm3, multiple lacunar infarcts or evidence of a single prior infarct >1\r\n             cm3, evidence of a cerebral contusion, encephalomalacia, arachnoid cysts, or brain\r\n             tumors (eg, meningioma) unless approved by the medical monitor.\r\n\r\n          3. Current presence of a clinically significant major psychiatric disorder according to\r\n             the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth\r\n             Edition (DSM IV) or any clinically significant symptom that could affect the subject's\r\n             ability to participate in the study.\r\n\r\n          4. Current clinically significant systemic illness that is likely to result in\r\n             deterioration of the subject's condition or affect the subject's safety during the\r\n             study.\r\n\r\n          5. History of clinically evident stroke or history of clinically significant carotid or\r\n             vertebrobasilar stenosis or plaque.\r\n\r\n          6. History of seizures, excluding febrile seizures in childhood.\r\n\r\n          7. Weight greater than 120 kg (264 lbs).\r\n\r\n          8. History or evidence of any clinically significant autoimmune disease or disorder of\r\n             the immune system.\r\n\r\n          9. Clinically significant infection within the last 30 days (eg, chronic persistent or\r\n             acute infection).\r\n\r\n         10. Treatment with immunosuppressive medications (eg, systemic corticosteroids) within the\r\n             last 90 days (topical and nasal corticosteroids and inhaled corticosteroids for asthma\r\n             are permitted) or chemotherapeutic agents for malignancy within the last three years.\r\n\r\n         11. Myocardial infarction within the last two years.\r\n\r\n         12. History of cancer within the last five years, with the exception of basal cell\r\n             carcinoma, and nonmetastatic squamous cell carcinoma of the skin.\r\n\r\n         13. Other clinically significant abnormality on screening (ie, Study 201 Visit 22 [Week\r\n             78], or Study 102 Visit 11 [Week 16]) physical, neurological, laboratory, or ECG\r\n             examination (eg, atrial fibrillation) that could compromise the study or be\r\n             detrimental to the subject.\r\n\r\n         14. Hemoglobin less than 11 g/dL at screening (ie, Study 201 Visit 22 [Week 78], or Study\r\n             102 Visit 11 [Week16]).\r\n\r\n         15. Smoking more than 20 cigarettes per day.\r\n\r\n         16. History of alcohol or drug dependence or abuse within the last two years.\r\n\r\n         17. Current use of anticonvulsant for seizures, anti-Parkinson's, anticoagulant (excluding\r\n             the use of aspirin 325 mg/day or less), or narcotic medications.\r\n\r\n         18. Any prior experimental treatment with AN1792 or other experimental immunotherapeutic\r\n             or vaccine for AD (other than bapineuzumab).\r\n\r\n         19. Any known hypersensitivity to any of the excipients contained in the study drug\r\n             formulation.\r\n\r\n         20. Women of childbearing potential.\r\n\r\n         21. Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants,\r\n             cerebrospinal fluid (CSF) shunts, metal fragments or foreign objects in the eyes,\r\n             skin, or body that would contraindicate a brain MRI scan (unless otherwise approved by\r\n             the Sponsor and/or its designees).\r\n      ","sponsor":"JANSSEN Alzheimer Immunotherapy Research & Development, LLC","sponsor_type":"Industry","conditions":"Alzheimer's Disease","interventions":[{"intervention_type":"Drug","name":"Drug: Bapineuzumab (AAB-001)","description":"IV q13w"}],"outcomes":[{"outcome_type":"primary","measure":"To assess the safety and tolerability of long-term treatment of bapineuzumab in subjects with AD.","time_frame":"3-84 months","description":"The incidence and severity of treatment-emergent adverse events (TEAEs);\r\nClinically important changes in safety assessment results (including, as appropriate, vital signs, weight, clinical laboratory tests, electrocardiograms [ECGs], brain magnetic resonance imaging [MRIs], physical and neurological examinations, and infusion site assessments)."},{"outcome_type":"secondary","measure":"To evaluate the efficacy of long-term treatment of bapineuzumab in subjects with AD.","time_frame":"3-84 months","description":"Change from Visit 2 (Pre-Day 1) and Visit 22 (Week 78) of Study AAB-001-201 for the following scales:\r\nAlzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog)\r\nDisability Assessment for Dementia (DAD)\r\nMini Mental State Examination (MMSE)\r\nChange from Study AAB-001-251Visit 1 (Day 1) for the following scales:\r\nDependence Scale\r\nResource Utilization in Dementia (RUD) Lite\r\nChange from Study 251 Screening Visit for the following scales for subjects entering from Study AAB-001-102 (US):\r\nADAS-Cog\r\nDAD\r\nMMSE"}]}
{"nct_id":"NCT01069627","start_date":"2006-12-31","phase":"Phase 2","enrollment":20,"brief_title":"A Study of Avastin (Bevacizumab) in Combination With Fotemustine in Patients With Metastatic Melanoma","official_title":"An Open-label Study to Assess the Anti-tumor Activity of Avastin in Combination With Fotemustine as First-line Therapy in Patients With Metastatic Melanoma","primary_completion_date":"2009-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-07-31","last_update":"2018-12-06","description":"This study will investigate the efficacy and safety of bevacizumab + fotemustine in patients with stage IV melanoma, previously untreated with chemo- or immunotherapy for metastatic disease. Patients will receive Avastin (15mg/kg intravenously[IV]) on Day 1 of every 3 week cycle, in combination with fotemustine (100mg/m IV) on Days 1, 8 and 15, followed by 4 weeks rest, followed by 100mg/m IV every 3 weeks for 4-6 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.","other_id":"ML19309","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  cutaneous malignant melanoma;\r\n\r\n          -  advanced, inoperable stage IV melanoma;\r\n\r\n          -  measurable and/or evaluable sites of metastases.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  prior chemotherapy and/or IFN/IL2 based immunotherapy for metastatic disease;\r\n\r\n          -  prior malignancies within past 5 years, with the exception of cured non-melanoma skin\r\n             cancer, or in situ cancer of cervix;\r\n\r\n          -  clinically significant cardiovascular disease;\r\n\r\n          -  ongoing treatment with aspirin (>325mg/day) or other medications known to predispose\r\n             to gastrointestinal ulceration.\r\n      ","sponsor":"Hoffmann-La Roche","sponsor_type":"Industry","conditions":"Malignant Melanoma","interventions":[{"intervention_type":"Drug","name":"Drug: bevacizumab [Avastin]","description":"15 mg/kg intravenously on day 1 of every 3 week cycle"},{"intervention_type":"Drug","name":"Drug: fotemustine","description":"100 mg/m intravenously on Days 1, 8, and 15, followed by 4 weeks of rest, then every 21 days up to 4 to 6 cycles"}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of Participants With Complete Response (CR) or Partial Response (PR)","time_frame":"Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months","description":"The percentage of participants with an objective response, defined as achieving CR or PR, as evaluated by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target), PR: at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD."},{"outcome_type":"primary","measure":"Percentage of Participants With Clinical Benefit of CR, PR, or Stable Disease (SD)","time_frame":"Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months","description":"The percentage of participants with an objective response of CR, PR, or SD, as evaluated by RECIST criteria. CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target), PR: at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD. SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for pregressive disease (PD). The clinical benefit was finally assessed by computing absolute frequencies and percentages participants with best overall tumor response equal to CR, PR, or SD."},{"outcome_type":"secondary","measure":"Time to Progression (TTP) - Percentage of Participants With an Event","time_frame":"Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months","description":"TTP was defined as the time in days from the date of first study treatment until the date of tumor progression or death. Failure events were defined as occurrence of death or progression of disease. Data for participants who were alive without tumor progression at the end of the study were censured at the end of the observation period."},{"outcome_type":"secondary","measure":"TTP - Time to Event","time_frame":"Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months","description":"TTP was defined as the time in days from the of first study treatment until the date of tumor progression or death. Failure events were defined as occurrence of death or progression of disease. Data for participants who were alive without tumor progression at the end of the study were censored at the end of the observation period. Median TTP was estimated using the Kaplan-Meier method."},{"outcome_type":"secondary","measure":"Duration of CR - Percentage of Participants With an Event","time_frame":"Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months","description":"Evaluated only for participants whose best overall response was CR. The start date was the date of first documented CR and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up."},{"outcome_type":"secondary","measure":"Duration of CR - Time to Event","time_frame":"Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months","description":"The start date was the date of first documented CR and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up. Median duration of CR was estimated using the Kaplan-Meier method."},{"outcome_type":"secondary","measure":"Duration of Overall Response of CR or PR - Percentage of Participants With an Event","time_frame":"Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months","description":"The start date was the date of first documented CR or PR and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up."},{"outcome_type":"secondary","measure":"Duration of Overall Response of CR or PR - Time to Event","time_frame":"Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months","description":"The start date was the date of first documented CR or PR and the end date was defined as the date of first documented progression of disease. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up. Median duration of CR or PR was estimated using the Kaplan-Meier method."},{"outcome_type":"secondary","measure":"Duration of Stable Disease - Percentage of Participants With an Event","time_frame":"Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months","description":"Stable disease was defined as achieving CR, PR, or SD. The start date was the date of first documented CR, PR, or SD and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up."},{"outcome_type":"secondary","measure":"Duration of Stable Disease - Time to Event","time_frame":"Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months","description":"Stable disease was defined as achieving CR, PR, or SD. The start date was the date of first documented CR, PR, or SD and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up. Median duration of CR, PR, or SD was estimated using the Kaplan-Meier method."},{"outcome_type":"secondary","measure":"Overall Survival (OS) - Percentage of Participants With an Event","time_frame":"Baseline, every 3 weeks to end-of-treatment, every 3 months during follow-up, to death or end-of-study (maximum of 36 months)","description":"OS was defined as the time from the starting day of the therapy up to death or the last date the participant was known to be alive."},{"outcome_type":"secondary","measure":"OS - Time to Event","time_frame":"Baseline, every 3 weeks to end-of-treatment, every 3 months during follow-up, to death or end-of-study (maximum of 36 months)","description":"The time from the starting day of the therapy up to death or the last date the participant was known to be alive. Median OS was estimated using the Kaplan-Meier method."},{"outcome_type":"secondary","measure":"Time to Treatment Failure (TTF) - Percentage of Participants With an Event","time_frame":"Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months","description":"The time from date of start of treatment to the earliest among date of progression, date of death due to any cause, or date of discontinuation due to reason other than 'Protocol Violation' or 'Administrative Problem'. For the participants who did not experience treatment failure, TTF was censored at last adequate tumour assessment."},{"outcome_type":"secondary","measure":"TTF - Time to Event","time_frame":"Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months","description":"The time from date of start of treatment to the earliest among date of progression, date of death due to any cause, or date of discontinuation due to reason other than 'Protocol Violation' or 'Administrative Problem'. For the participants who did not experience treatment failure, TTF was censored at last adequate tumour assessment. Median TTF was estimated using the Kaplan-Meier method."},{"outcome_type":"secondary","measure":"Time to CR - Percentage of Participants With an Event","time_frame":"Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months","description":"The time between date of start of treatment until first documented CR. This analysis included all responders. Participants who did not achieve a confirmed CR were censored at last adequate tumour assessment date or at maximum follow-up."},{"outcome_type":"secondary","measure":"Time to CR - Time To Event","time_frame":"Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months","description":"The time between date of start of treatment until first documented CR. This analysis included all responders. Participants who did not achieve a confirmed CR were censored at last adequate tumour assessment date or at maximum follow-up. Mean time to CR was estimated using the Kaplan-Meier method."},{"outcome_type":"secondary","measure":"Time to Overall Response of CR or PR - Percentage of Participants With an Event","time_frame":"Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months","description":"The time between date of start of treatment until first documented response of CR or PR. This analysis included all responders. Participants who did not achieve a confirmed CR or PR were censored at last adequate tumour assessment date or at maximum follow-up."},{"outcome_type":"secondary","measure":"Time to Overall Response of CR or PR - Time to Event","time_frame":"Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months","description":"The time between date of start of treatment until first documented response of CR or PR. This analysis included all responders. Participants who did not achieve a confirmed CR or PR were censored at last adequate tumor assessment date or at maximum follow-up. Mean time to CR or PR was estimated using the Kaplan-Meier method."}]}
{"nct_id":"NCT00847158","start_date":"2006-12-31","phase":"N/A","enrollment":36,"brief_title":"A Clinical Trial of Phacoemulsification Versus Phacoemulsification & the iStent Implantation in POAG Patients","official_title":"A Randomized, Double-Masked Clinical Trial of Phacoemulsification Compared With Phacoemulsification and Micro-Bypass Stent Implantation in Patients With POAG","primary_completion_date":"2008-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-03-31","last_update":"2009-02-19","description":"This was a prospective, double-masked, 15-month clinical trial comparing efficacy of phacoemulsification alone to combined phacoemulsification and implantation of the iStent trabecular micro-bypass stent in patients with primary open-angle glaucoma.","other_id":"iStent Washout study","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  a previous diagnosis of POAG\r\n\r\n          -  an IOP of > 18 mm Hg at three separate visits if on one medication, or subjects on at\r\n             least two medications with uncontrolled IOP on three separate visits.\r\n\r\n          -  all patients were deemed likely to follow surgeon instructions and were able to give\r\n             informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  any glaucoma diagnosis other than POAG\r\n\r\n          -  the presence of peripheral anterior synechiae (PAS)\r\n\r\n          -  a cloudy cornea likely to inhibit gonioscopic view of the angle\r\n\r\n          -  any previous ocular surgery\r\n\r\n          -  history of trauma or ocular surface disease\r\n\r\n          -  the presence of peripheral anterior synechiae (PAS)\r\n\r\n          -  a cloudy cornea likely to inhibit gonioscopic view of the angle\r\n      ","sponsor":"University of Turin, Italy","sponsor_type":"Other","conditions":"Primary Open Angle Glaucoma and Cataracts","interventions":[{"intervention_type":"Procedure","name":"Procedure: phacoemulsification alone","description":"phacoemulsification alone"},{"intervention_type":"Device","name":"Device: iStent Trabecular Micro-Bypass Stent","description":"phacoemulsification and implantation of the iStent trabecular micro-bypass stent"}],"outcomes":[{"outcome_type":"primary","measure":"Primary outcomes included IOP and reduction in medication use.","time_frame":"15 month"}]}
{"nct_id":"NCT00415168","start_date":"2006-12-31","phase":"Phase 2","enrollment":53,"brief_title":"Pemetrexed Plus Cisplatin as First-Line Treatment in Stage IV or Recurrence of Gastric Cancer","official_title":"Phase 2 Study of ALIMTA (Pemetrexed) Plus Cisplatin as First-Line Treatment of Gastric Cancer","primary_completion_date":"2009-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-07-31","last_update":"2010-08-17","description":"Study H3E-MW- S108 is a multicenter, single arm, open-label Phase 2 study to determine the response rate of pemetrexed plus cisplatin in patients with Stage IV gastric cancer, not amenable to curative surgery, or recurrence after prior surgery, who have had no prior chemotherapy. It was planned to enroll approximately 50 patients who qualified for tumor response population.","other_id":"10874","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically confirmed diagnosis of adenocarcinoma of the gastric. Stage IV disease,\r\n             not amenable to curative surgery, or disease recurrence after prior surgery.\r\n\r\n          -  Disease status must be that of measurable disease with presence of at least one\r\n             measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST)\r\n             criteria.\r\n\r\n          -  In bidimensionally measurable lesions the longest diameter should be selected for\r\n             measurement.\r\n\r\n          -  Tumor lesions in areas of prior radiation therapy may be included only if they were\r\n             clearly progressing.\r\n\r\n          -  If only a single lesion is present in a patient who had prior therapy for gastric\r\n             adenocarcinoma, the neoplastic nature of the lesion should be confirmed by cytology\r\n             and/or histology.\r\n\r\n          -  Ultrasound and clinical examination are not allowed for assessment of measurable\r\n             disease.\r\n\r\n          -  Elevation of tumor markers, pleural or pericardial effusion, ascites, bone lesions,\r\n             cystic lesions, or carcinomatous lymphangitis pulmonis/cutis is defined as not being\r\n             measurable.\r\n\r\n          -  Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Scale.\r\n\r\n          -  Estimated life expectancy of at least 12 weeks.\r\n\r\n          -  No prior chemotherapy or radiotherapy.\r\n\r\n          -  Patient compliance and geographic proximity that allow adequate follow-up.\r\n\r\n        Adequate organ function including the following:\r\n\r\n          -  Bone marrow: absolute neutrophil count 1.5 x 10 to the ninth power/liter (L),\r\n             platelets 100 x 10 to the ninth power/L, hemoglobin >=9 grams per deciliter (g/dL).\r\n\r\n          -  Hepatic: bilirubin <=1.5 x upper limit of normal (ULN); alkaline phosphatase,\r\n             aspartate transaminase and alanine transaminase <=3.0 x ULN.\r\n\r\n          -  Renal: Calculated creatinine clearance >=45 milliliters (ml)/minute.\r\n\r\n          -  Men or women, age 18 to 70 years.\r\n\r\n          -  For women: Must be surgically sterile, post-menopausal, or compliant with a medically\r\n             approved contraceptive regimen during and for 3 months after the treatment period;\r\n             must have a negative serum or urine pregnancy test within 7 days before study\r\n             enrollment and must not be breast-feeding.\r\n\r\n          -  For men: Must be surgically sterile, or compliant with a contraceptive regimen during\r\n             and for 3 months after the treatment period.\r\n\r\n          -  Signed informed consent from patient.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Have received treatment within the last 30 days with a drug that has not received\r\n             regulatory approval for any indication at the time of study entry.\r\n\r\n          -  Concurrent administration of any other tumor therapy.\r\n\r\n          -  Active infection.\r\n\r\n          -  Serious concomitant disorders that would compromise the safety of the patient or\r\n             compromise the patient's ability to complete the study, at the discretion of the\r\n             investigator.\r\n\r\n          -  Pregnancy.\r\n\r\n          -  Breast-feeding.\r\n\r\n          -  History of significant neurological or mental disorder, including seizures or\r\n             dementia.\r\n\r\n          -  Have had a prior malignancy other than gastric cancer, carcinoma in situ of the\r\n             cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and\r\n             definitively treated at least 5 years previously with no subsequent evidence of\r\n             recurrence.\r\n\r\n          -  Patients with a history of low grade (Gleason score less than or equal to 6) localized\r\n             prostate cancer will be eligible even if diagnosed less than 5 years previously.\r\n\r\n          -  Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs 2 days\r\n             before, the day of, and 2 days after the dose of pemetrexed plus cisplatin.\r\n\r\n          -  If a patient is taking a nonsteroidal anti-inflammatory drug (NSAID) or salicylate\r\n             with a long half-life it should not be taken 5 days before, the day of, and 2 days\r\n             after the dose of pemetrexed plus cisplatin.\r\n\r\n          -  Clinically significant ascites or pleural effusion that is apparent at clinical\r\n             examination and cannot be controlled by drainage or other procedures prior to study\r\n             enrollment. NOTE: Small effusions noted on computed tomography (CT) scan do not\r\n             exclude the patient from study enrollment.\r\n\r\n          -  Inability or unwillingness to take folic acid, vitamin B12 supplementation, or\r\n             dexamethasone.\r\n\r\n          -  Known or suspected brain metastasis. Patients who have clinical signs or symptoms that\r\n             are suspicious of brain metastasis must have a pretreatment CT or magnetic resonance\r\n             imaging (MRI) of the brain. A patient with documented brain metastasis, at the time of\r\n             consideration for study entry or in the past, will be excluded from entering in the\r\n             study.\r\n      ","sponsor":"Eli Lilly and Company","sponsor_type":"Industry","conditions":"Gastric Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: pemetrexed","description":"700 milligrams/meters squared (mg/m2), intravenous (IV), every 21 days x 6 cycles"},{"intervention_type":"Drug","name":"Drug: cisplatin","description":"75 mg/m2, IV, every 21 days x 6 cycles"}],"outcomes":[{"outcome_type":"secondary","measure":"Number of Participants Who Died During the Study","time_frame":"During study drug therapy up to six or eight 21-day cycles or treatment; maximum duration of study follow-up was 17.4 months"},{"outcome_type":"primary","measure":"Percentage of Participants With Objective Response (Objective Response Rate)","time_frame":"Baseline to time of response up to six or eight 21-day cycles of treatment","description":"Tumor responder is defined as participants exhibiting a best overall study response of complete response (CR; disappearance of all target lesions) or partial response (PR; 30% decrease in sum of longest diameter of target lesions). Non-responders are those who did not meet the above criteria."},{"outcome_type":"secondary","measure":"Duration of Response","time_frame":"Time of response to progressive disease up to six or eight 21-day cycles of treatment; maximum duration of study follow-up was 17.4 months","description":"Measured from the time of first documentation of CR or PR (whichever status is first recorded) until the date of time to disease progression."},{"outcome_type":"secondary","measure":"Progression Free Survival (PFS)","time_frame":"Baseline to measured progressive disease or death up to six or eight 21-day cycles of treatment; maximum duration of study follow-up was 17.4 months","description":"Defined as time from baseline to the date of disease progression or death on study, whichever occurs first. The PFS 1 definition from the United States Food and Drug Administration (FDA) draft guidance on clinical endpoints was used (FDA 2005)."},{"outcome_type":"secondary","measure":"Overall Survival","time_frame":"Baseline to date of death from any cause up to six or eight 21-day cycles of treatment; maximum duration of study follow-up was 17.4 months","description":"Defined as the time from baseline to date of death due to any cause. Survival time is censored at the date of last contact for patients who are still alive or lost to follow up."},{"outcome_type":"secondary","measure":"Number of Participants With Pharmacology Toxicity - Grade 3 or 4 Laboratory Toxicity Possibly Related to Study Therapy","time_frame":"Baseline through six or eight 21-day cycles of treatment, up to 30 days after study drug discontinuation","description":"Common toxicity criteria (CTC) Grade 3 (severe) or 4 (life-threatening or disabling) laboratory toxicity possibly related to study therapy. A grading (severity) scale is provided for each event term. Grades range from 0 (none) to 5 (death)."},{"outcome_type":"secondary","measure":"Number of Participants With Pharmacology Toxicity - Grade 3 or 4 Non-Laboratory Toxicity Possibly Related to Study Therapy","time_frame":"Baseline through six or eight 21-day cycles of treatment, up to 30 days after study drug discontinuation","description":"Common toxicity criteria (CTC) Grade 3 (severe) or 4 (life-threatening or disabling) non-laboratory toxicity possibly related to study therapy. A grading (severity) scale is provided for each event term. Grades range from 0 (none) to 5 (death)."}]}
{"nct_id":"NCT00430495","start_date":"2006-12-31","phase":"Phase 2","enrollment":256,"brief_title":"A Phase 2 Dose-finding Study of Atacicept in Subjects With Rheumatoid Arthritis (AUGUST I)","official_title":"A Randomized, Double-blind, Placebo-controlled, Multicentre, Phase II Dose-finding Study of Atacicept Given Subcutaneously in Subjects With Rheumatoid Arthritis and Inadequate Response to TNFa Antagonist Therapy","primary_completion_date":"2009-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-09-30","last_update":"2016-02-17","description":"This was a double-blind, placebo-controlled, parallel-arm, multicentre, prospective dose-finding trial of the safety and efficacy of atacicept in subjects with active rheumatoid arthritis who had failed a three month therapeutic trial with a tumor necrosis factor alpha (TNFa) antagonist due to lack of efficacy.","other_id":"27298","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Rheumatoid arthritis (RA) satisfying American College of Rheumatology (ACR) diagnostic\r\n             criteria with a disease history of at least one year\r\n\r\n          2. Male or female greater than or equal to (>=)18-years of age at time of informed\r\n             consent\r\n\r\n          3. Active RA as defined by:\r\n\r\n               -  >=8 swollen joints (66-joint count),\r\n\r\n               -  >=8 tender joints (68-joint count), and\r\n\r\n               -  C-reactive protein (CRP) >=10 milligram per liter (mg/L) (central laboratory)\r\n                  and/or erythrocyte sedimentation rate (ESR) >= to 28 millimeter per hour (mm/h)\r\n\r\n          4. Failure of at least one TNFa antagonist therapy (previously or at the time of\r\n             screening) as specified in the protocol\r\n\r\n          5. Other protocol defined inclusion criteria could apply\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Any condition, including laboratory findings or findings in the medical history or\r\n             pre-trial assessments, that in the opinion of the Investigator constitutes a risk or a\r\n             contraindication for the subject's participation in the trial or that could interfere\r\n             with the trial objectives, conduct or evaluation\r\n\r\n          2. Treatment with biologics aiming at B cell modulation such as rituximab or belimumab\r\n             within 2 years before study Day 1\r\n\r\n          3. Any previous treatment with anakinra (Kineret), abatacept (Orencia) or tocilizumab\r\n             within 3 months before study Day 1\r\n\r\n          4. Use of etanercept (Enbrel) within 28 days before study Day 1, or of infliximab\r\n             (Remicade) or adalimumab (Humira) within 60 days before study Day 1\r\n\r\n          5. Participation in any interventional clinical trial with an unapproved investigational\r\n             therapy within the 3 months before the start of this study (or within 5 half-lives of\r\n             the investigated compound before study Day 1, whichever is longer)\r\n\r\n          6. Other protocol defined exclusion criteria could apply\r\n      ","sponsor":"EMD Serono","sponsor_type":"Industry","conditions":"Rheumatoid Arthritis","interventions":[{"intervention_type":"Drug","name":"Drug: Atacicept","description":"Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks."},{"intervention_type":"Drug","name":"Drug: Atacicept","description":"Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks."},{"intervention_type":"Drug","name":"Drug: Atacicept","description":"Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks."},{"intervention_type":"Drug","name":"Drug: Placebo matched to atacicept","description":"Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks."}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of Participants Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP) at Week 26","time_frame":"Week 26","description":"ACR20-CRP response is defined as greater than or equal to (>=) 20 percent (%) improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=20% improvement in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP)."},{"outcome_type":"secondary","measure":"Percentage of Participants Achieving American College of Rheumatology 50 Response Based on CRP (ACR50-CRP) at Week 26","time_frame":"Week 26","description":"ACR50-CRP response is defined as >=50% improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=50% improvement in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP)."},{"outcome_type":"secondary","measure":"Percentage of Participants Achieving American College of Rheumatology 70 Response Based on CRP (ACR70-CRP) at Week 26","time_frame":"Week 26","description":"ACR70-CRP response is defined as >=70% improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=70% improvement in at least 3 of the following 5 measures: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP)."},{"outcome_type":"secondary","measure":"Percentage of Participants Achieving Disease Activity Score in 28 Joints (DAS28) Based on CRP (DAS28-CRP) of Less Than or Equal to (<=) 3.2 at Week 26","time_frame":"Week 26","description":"DAS28-CRP incorporates non-graded joint counts for tenderness and swelling based on a total of 28 joints, CRP as a marker of inflammation, and a general health assessment using a 100-millimeter (mm) visual analog scale (the participant's global assessment of disease activity). DAS28 ranges between 0 and 10 representing current disease activity. A value above 5.1 represents high disease activity, a value below 3.2 represents low disease activity, and a value below 2.6 represents remission."},{"outcome_type":"secondary","measure":"Percentage of Participants Achieving Disease Activity Score in 28 Joints (DAS28) Based on CRP (DAS28-CRP) of <=2.6 at Week 26","time_frame":"Week 26","description":"DAS28-CRP incorporates non-graded joint counts for tenderness and swelling based on a total of 28 joints, CRP as a marker of inflammation, and a general health assessment using a 100 mm visual analog scale (the participant's global assessment of disease activity). DAS28 ranges between 0 and 10 representing current disease activity. A value above 5.1 represents high disease activity, a value below 3.2 represents low disease activity, and a value below 2.6 represents remission."},{"outcome_type":"secondary","measure":"Percentage of Participants Achieving Improvement in Health Assessment Questionnaire Disability Index (HAQ-DI) of at Least 0.3 From Baseline at Week 26","time_frame":"Week 26","description":"The HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range is 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Percentage of participants achieving improvement in HAQ-DI of at least 0.3 from baseline at Week 26 was reported."},{"outcome_type":"secondary","measure":"Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Week 26","time_frame":"Week 26","description":"The EULAR response criteria evaluate change in DAS28 scores represented as \"good response\", \"moderate response\", or \"no response\" considering both the current DAS28 score and the observed improvement from baseline. Participants were considered to have \"good\" or \"moderate\" EULAR response if at the time of assessment, their DAS28 score was <=5.1 and the improvement from baseline in their DAS28 score was greater than (>) 0.6; or if at the time of assessment, their DAS28 score was >5.1 and improvement from baseline in their DAS28 score was >1.2."},{"outcome_type":"secondary","measure":"Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)","time_frame":"Baseline up to Week 38","description":"An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect."}]}
{"nct_id":"NCT00418665","start_date":"2006-12-31","phase":"Phase 2","enrollment":39,"brief_title":"A Safety and Efficacy Study to Evaluate AMG 531 Treatment in Subject With Myelodysplastic Syndrome Receiving Revlimid","official_title":"A Randomized, Double Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) Receiving Lenalidomide.","primary_completion_date":"2009-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-10-31","last_update":"2011-01-24","description":"This is a dose and schedule finding study of AMG 531 designed to assess the activity of AMG 531 to reduce the rate of clinically significant bleeding and blood transfusions in subjects with myelodysplastic syndrome (MDS) receiving lenalidomide. Subjects with MDS that are planned to receive at least four cycles of lenalidomide for treatment of their disease are appropriate to screen for this study. All subjects meeting the eligibility criteria will receive lenalidomide 10 mg capsule by mouth daily every day of each 28-day cycle. Subjects will receive AMG 531 or placebo once a week by subcutaneous injection for 16 weeks.","other_id":"20060102","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosis of MDS by bone marrow biopsy based on the World Health Organization (WHO)\r\n             classification\r\n\r\n          -  Low or Intermediate-1 risk category MDS using the IPSS\r\n\r\n          -  Planned to receive lenalidomide 10 mg capsule by mouth daily for all 28 days of each\r\n             cycle for at least 4 cycles\r\n\r\n          -  Eastern Cooperative Oncology (ECOG) performance status of 0-2\r\n\r\n          -  Subjects must be at least 18 years of age or older\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior exposure to >3 cycles of lenalidomide\r\n\r\n          -  Exposure to lenalidomide within the last 30 days\r\n\r\n          -  Prior history of leukemia or aplastic anemia\r\n\r\n          -  Prior history of stem cell transplantation\r\n\r\n          -  Prior malignancy (other than in situ cervical cancer or basal cell cancer of the skin)\r\n             unless treated with curative intent and without evidence of disease for 3 years before\r\n             randomization\r\n\r\n          -  Active or uncontrolled infections\r\n\r\n          -  Unstable angina, congestive heart failure [NYHA > class II], uncontrolled hypertension\r\n             [diastolic > 100 mmHg], uncontrolled cardiac arrhythmia, or recent (within 1 year)\r\n             myocardial infarction\r\n\r\n          -  History of arterial thrombosis ( eg, stroke or transient ischemic attack) in the past\r\n             year\r\n\r\n          -  History of venous thrombosis in the past year\r\n\r\n          -  Received IL-11 within 4 weeks of screening\r\n\r\n          -  Less than 4 weeks since receipt of any investigational drug or device\r\n\r\n          -  Have previously received any other thrombopoietic growth factor\r\n\r\n          -  Pregnant or breast feeding\r\n\r\n          -  Subjects of reproductive potential who are not using adequate contraceptive\r\n             precautions, in the judgment of the investigator\r\n\r\n          -  Known hypersensitivity to any recombinant E coli-derived product\r\n      ","sponsor":"Amgen","sponsor_type":"Industry","conditions":"Myelodysplastic Syndromes|Thrombocytopenia","interventions":[{"intervention_type":"Biological","name":"Biological: AMG 531","description":"AMG 531 will be administered by subcutaneous injection at a dose of 500 or 750 g."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Subjects in the control group will receive placebo via subcutaneous injection."}],"outcomes":[{"outcome_type":"primary","measure":"Occurrence of a Clinically Significant Thrombocytopenic Event","time_frame":"Treatment period through interim follow-up visit (up to 16 weeks)","description":"Occurrence of one or more clinically significant thrombocytopenic events, defined as either Common Terminology Criteria for Adverse Events (CTCAE) v. 3 grade 3 or 4 thrombocytopenia starting from week 3 of cycle 1 or receipt of platelet transfusions starting from week 1 of cycle 1 and continuing through the end of treatment visit."},{"outcome_type":"secondary","measure":"Lenalidomide Dose Reduction and Delay Due to Thrombocytopenia","time_frame":"Treatment period (up to 16 weeks)","description":"Occurrence of lenalidomide dose reduction and delay due to thrombocytopenia"},{"outcome_type":"secondary","measure":"Achieving an Overall Response (Complete Response (CR) or Partial Response (PR)) Determined by the Investigator Based on Modified International Working Group 2006 Response Criteria Guidelines","time_frame":"Treatment period and post-treatment follow-up (up to 21 weeks)","description":"CR = decrease in bone marrow blast (≤5%) and improvement in peripheral blood counts (Hgb ≥ 11 g/dL, platelets ≥ 100x10^9/L, neutrophils ≥ 1x10^9/L, peripheral blasts=0%). PR = improvement in peripheral blood counts plus a decrease in bone marrow blasts ≥50% but not ≤5, or decrease in International Prognostic Scoring System score."},{"outcome_type":"secondary","measure":"Platelet Transfusion","time_frame":"Treatment period (up to 16 weeks)","description":"Occurrence of one or more platelet transfusions during the treatment period"}]}
{"nct_id":"NCT00853879","start_date":"2006-12-31","phase":"N/A","enrollment":150,"brief_title":"An Exploratory, Randomized, Blinded, Placebo-Controlled Trial of Folic Acid and L-methylfolate in Parkinson's Disease","official_title":"An Exploratory, Randomized, Blinded, Placebo-Controlled Trial of Folic Acid and L-methylfolate in Parkinson's Disease","primary_completion_date":"2010-06-30","study_type":"Interventional","rec_status":"Terminated","completion_date":"2010-06-30","last_update":"2015-05-15","description":"This study is being conducted to assess the impact of folate and L-methylfolate on the progression of Parkinson's. The investigators are specifically looking for the effect of these nutritional supplements in Parkinson's patients who have an antibody that effects their body's utilization of folate. An antibody is a protein produced by the body's immune system to recognize foreign substances. Normally, people do not have an antibody that prevents folate from working properly in the brain but it appears that some people may have such an antibody. Folate is an important vitamin that takes part in many critical cell functions so an antibody that prevented it from entering the brain properly could cause or worsen certain neurological disorders like Parkinson's. The results of this preliminary study will help determine whether it is reasonable to proceed with further study of any of these supplements for the treatment of Parkinson's. Patients interested in participating will have a blood test to see if they have folate antibodies. Patients with the antibody will be eligible to further participate in the study. The investigators will measure the effects of folate and L-methylfolate on Parkinson's disease by measuring the change in your Parkinson's disease symptoms over three months of treatment. The investigators will also be looking at the blood of some individuals who do not have Parkinson's. This is called a control group and will allow us to compare how common the folate antibody is in the general population compared with the Parkinson's population.","other_id":"GCRC 0143","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":30,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  PD subjects:\r\n\r\n               -  Diagnosis of Parkinson's based upon the presence of 2 or more of the cardinal\r\n                  clinical features of the disease as determined by a movement disorders\r\n                  specialist.\r\n\r\n               -  Age > 30.\r\n\r\n               -  Able to provide informed consent.\r\n\r\n               -  All anti-Parkinson's medications will be permitted but all evaluations will be\r\n                  done in the medication OFF state (at least 12 hours following the last dose of\r\n                  medication).\r\n\r\n          -  Healthy Controls *Age > 30\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  PD Subjects:\r\n\r\n               -  Age < 30.\r\n\r\n               -  Presence of concomitant active neurological disorders as deemed significant by\r\n                  the investigator.\r\n\r\n               -  History of clinically significant diabetes, vascular disease, renal, thyroid or\r\n                  hepatic dysfunction or of Leber's optic neuropathy as determined by the\r\n                  investigator.\r\n\r\n               -  History of significant medical illness as determined by the investigators.\r\n\r\n               -  The following medications will be excluded: thiazide diuretics, azathioprine,\r\n                  phenytoin, phenobarbital, primidone, sulfa-containing medications, cimetidine,\r\n                  anti-tuberculosis medications, methotrexate, chemotherapeutic agents and oral\r\n                  contraceptives.\r\n\r\n               -  Subjects taking vitamin supplementation in excess of one daily standard\r\n                  multivitamin.\r\n\r\n               -  Pregnancy (excluded not for perceived risk but because most pregnant women are\r\n                  taking supplemental folate).\r\n\r\n          -  Healthy Controls:\r\n\r\n               -  Age < 30\r\n\r\n               -  Any known active neurological condition deemed significant by the investigator.\r\n\r\n               -  History of significant, active renal or hepatic dysfunction as determined by the\r\n                  investigator.\r\n\r\n               -  History of significant active medical illness as determined by the investigators.\r\n\r\n               -  The following medications will be excluded: thiazide diuretics, azathioprine,\r\n                  phenytoin, phenobarbital, primidone, sulfa-containing medications, cimetidine,\r\n                  anti-tuberculosis medications, methotrexate, chemotherapeutic agents and oral\r\n                  contraceptives.\r\n\r\n               -  Subjects taking vitamin supplementation in excess of one standard daily\r\n                  multivitamin.\r\n\r\n               -  Pregnancy (most pregnant women are taking folate).\r\n      ","sponsor":"Northwell Health","sponsor_type":"Other","conditions":"Parkinson's Disease","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Folic Acid, Vitamin B6, Vitamin B12","description":"Intervention #1. A combination of the following vitamin supplements: 2.5mg of folate, 25mg of vitamin B6 and 2mg of vitamin B12. This combination will be described as \"triple therapy with folate.\""},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: B6, B12, L-methylfolate","description":"Intervention #2. A combination of the following vitamin supplements: 2.8mg of L-methylfolate, 25 mg of vitamin B6 and 2mg of vitamin B12."},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: B6, B12, Placebo","description":"Intervention #3. A combination of the following vitamin supplements: 25mg of vitamin B6 and 2mg of vitamin B12 without supplementary folate or L-methylfolate. This combination will be described as \"triple therapy with placebo\""}],"outcomes":[{"outcome_type":"primary","measure":"This study is being conducted to assess the impact of folate and L-methylfolate on the progression of Parkinson's. The primary endpoint variable will be the change in UPDRS from baseline to 3 months (\"change score\").","time_frame":"3 years"},{"outcome_type":"secondary","measure":"Secondary endpoints will be Folate receptor autoantibody levels and plasma Hcy levels","time_frame":"3 years"}]}
{"nct_id":"NCT00386451","start_date":"2006-11-30","phase":"N/A","enrollment":60,"brief_title":"Comparing a Closing System Without a Needle With Positive Pressure to a Heparin Lock With Positive Pressure","official_title":"Prospective Study Which Compares the Use of a Closing System Without a Needle and With Positive Pressure to a Heparin Lock With Positive Pressure for Patients With a Catheter for Chemotherapy","primary_completion_date":"2007-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-07-31","last_update":"2009-04-27","description":"A prospective randomized study to compare 2 groups: - heparine lock with positive pressure - lock without a needle with positive pressure","other_id":"2006/331","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Oncological patients who require intravenous chemotherapy\r\n      ","sponsor":"University Hospital, Ghent","sponsor_type":"Other","conditions":"Neoplasms","interventions":[{"intervention_type":"Device","name":"Device: Catheter locking systems"}],"outcomes":[{"outcome_type":"primary","measure":"Clinical evaluation"}]}
{"nct_id":"NCT00468078","start_date":"2006-11-30","phase":"Phase 3","enrollment":78,"brief_title":"Efficacy and Safety of F-18 FPCIT PET in Parkinson's Disease and Essential Tremor Patients","official_title":"The Single Center, Phase III Clinical Trial to Evaluate the Efficacy and the Safety of [18F]FPCIT Positron Emission Tomography in Parkinson's Disease and Essential Tremor Patients","primary_completion_date":"2007-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-10-31","last_update":"2016-01-13","description":"The purpose of this study is to determine whether F-18 FPCIT is effective and safe radiopharmaceutical for the objective diagnosis of Parkinson's disease.","other_id":"FPCITKR001","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Parkinson's disease\r\n\r\n          -  Male or female with age over 40 years\r\n\r\n          -  Clinical diagnosis of Parkinson's disease\r\n\r\n          -  Ability to give informed consent\r\n\r\n        Essential tremor\r\n\r\n          -  Male or female with age over 40 years\r\n\r\n          -  Clinical diagnosis of Essential tremor\r\n\r\n          -  Ability to give informed consent\r\n\r\n        Healthy volunteers\r\n\r\n          -  Male or female with age over 40 years\r\n\r\n          -  No any symptoms or sign suggesting Parkinson's disease or essential tremor\r\n\r\n          -  Ability to give informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n        Parkinson's disease and essential tremor\r\n\r\n          -  Current pregnancy and breast feeding\r\n\r\n          -  Current or past medical history of cardiac and neuropsychiatric disease\r\n\r\n          -  Clinical evidence of dementia\r\n\r\n          -  Inability to hold antiparkinsonian medication\r\n\r\n          -  History of surgical therapy for tremor\r\n\r\n          -  Severe or unstable medical or psychiatric condition\r\n\r\n          -  Medication affecting CNS in last 6 months(e.g. CNS stimulants, sympathomimetics)\r\n\r\n          -  Prior participation in other research protocol within 30 days\r\n\r\n        Healthy volunteers\r\n\r\n          -  Current pregnancy and breast feeding\r\n\r\n          -  Current or past medical history of cardiac and neuropsychiatric disease\r\n\r\n          -  Severe or unstable medical or psychiatric condition\r\n\r\n          -  Drug abuse or medication affecting CNS (e.g. CNS stimulants, sympathomimetics) within\r\n             6 months\r\n\r\n          -  Prior participation in other research protocol within 30 days\r\n      ","sponsor":"Asan Medical Center","sponsor_type":"Other","conditions":"Parkinson's Disease","interventions":[{"intervention_type":"Procedure","name":"Procedure: PET/CT","description":"10min acquisition, 90min after injection of F-18 FPCIT"},{"intervention_type":"Drug","name":"Drug: F-18 FPCIT","description":"5mCi, intravenous injection"}],"outcomes":[{"outcome_type":"primary","measure":"diagnostic sensitivity and specificity, and acute complication","time_frame":"1 month"},{"outcome_type":"secondary","measure":"correlation of specific striatal uptake to non specific uptake ratio of F-18 FPCIT and clinical sererity (H&Y stage)","time_frame":"10 days"}]}
{"nct_id":"NCT00951561","start_date":"2006-11-30","phase":"N/A","enrollment":115,"brief_title":"A Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen","official_title":"A Randomized Four-Way Crossover Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen","primary_completion_date":"2009-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-09-30","last_update":"2011-06-16","description":"The purpose of this study is to compare the Vipon tampon with ibuprofen in relieving pain in women with dysmenorrhea. Subjects completed a total of 4 treatment intervals; each subject was randomized to use the VIPON as their treatment for two intervals and Ibuprofen as their treatment for two intervals.","other_id":"AWP01-01","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Females ages >= 18 years\r\n\r\n          -  4 consecutive monthly menstrual cycles\r\n\r\n          -  Self-assessment of dysmenorrhea\r\n\r\n          -  Non-pregnant status\r\n\r\n          -  Agrees to use adequate birth control during the trial\r\n\r\n          -  Consents to use tampons through the test of cure assessment\r\n\r\n          -  Provides informed consent for participating in the trial\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prohibited use of pain medication 4 hours prior to treatment and during the first 2\r\n             hours after treatment with study medication\r\n\r\n          -  Positive pregnancy test\r\n\r\n          -  Unwilling or unable to comply with protocol\r\n\r\n          -  Allergic to ibuprofen\r\n      ","sponsor":"Another Way Products","sponsor_type":"Industry","conditions":"Dysmenorrhea","interventions":[{"intervention_type":"Device","name":"Device: Vipon","description":"The Vipon is a tampon with a small motor unit within, which produces vibratory stimulation, used during menstruation to provide pain relief for women with dysmenorrhea."},{"intervention_type":"Drug","name":"Drug: Ibuprofen","description":"400 mg daily"}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of Intervention Uses That Resulted in at Least 1 Point Decrease in Pain and Requiring no Rescue Medication Using the Modified Melzack-McGill Scale Using a Mixed Model","time_frame":"1 month, 2 months, 3 months, 4 months","description":"Modified Melzack-McGill Scale measures general pain (0=none, 1-3=mild, 4-6=moderate, 7-9=severe, 10=worst pain) Total Number of Uses Analyzed is a sum of the Number of Uses collected at each time point."}]}
{"nct_id":"NCT00414323","start_date":"2006-11-30","phase":"Phase 1","enrollment":35,"brief_title":"Evaluation of the Effects of Duloxetine on Norepinephrine","official_title":"Evaluation of the Effects of Duloxetine on Norepinephrine Transporter Inhibition in Healthy Subjects","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-05-31","last_update":"2007-06-12","description":"The purpose of this study is to evaluate how taking duloxetine 60mg every day affects the transfer of two normal body chemicals, 3,4-dihydroxyphenylglycol (DHPG) and norepinephrine (NE), across cells in blood and cerebrospinal fluid.","other_id":"9547","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Healthy subjects between the ages of 18-65 years are nonsmokers or are willing to refrain\r\n        from smoking and are not taking concomitant medications which may inhibit or induce CYP1A2\r\n        or CYPD6 or is an MAOI.\r\n      ","sponsor":"Eli Lilly and Company","sponsor_type":"Industry","conditions":"Major Depressive Disorder","interventions":[{"intervention_type":"Drug","name":"Drug: Duloxetine"},{"intervention_type":"Drug","name":"Drug: Escitalopram"},{"intervention_type":"Drug","name":"Drug: Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"Concentrations of DHPG and NE in plasma (in sitting and standing positions), urine, and CSF after multiple daily doses (steady state)."},{"outcome_type":"secondary","measure":"Effect of duloxetine versus escitalopram on ex vivo reuptake inhibition of NE and F-hydroxytryptamine (5-HT) in serum and relationship to exposure."},{"outcome_type":"secondary","measure":"Effect of duloxetine versus escitalopram on heart rate variability."},{"outcome_type":"secondary","measure":"Ratio of duloxetine exposure in plasma to CSF at steady state."},{"outcome_type":"secondary","measure":"Relationship between DHPG and NE concentrations and duloxetine exposure in CSF and plasma."}]}
{"nct_id":"NCT01122992","start_date":"2006-11-30","phase":"N/A","enrollment":30,"brief_title":"Prospective Evaluation of Limbal Relaxing Incision (LRI) in Conjunction With Phacoemulsification Surgery for Astigmatic Correction in Chinese Eyes","official_title":"Prospective Evaluation of Limbal Relaxing Incision (LRI) in Conjunction With Phacoemulsification Surgery for Astigmatic Correction in Chinese Eyes","primary_completion_date":"2010-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2010-12-31","last_update":"2010-05-13","description":"The main purpose of this study is to evaluate the use of limbal relaxing incision (LRI) for astigmatic correction. LRI is a procedure where a pair of incisions is made in the peripheral part of the cornea so as to alter its shape and improve the focusing power of the eye.","other_id":"R489/38/2006","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":21,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Study subjects should be at least 21 years old, and not older than 60 years old\r\n\r\n          -  Only Chinese patients will be eligible for this study\r\n\r\n          -  Presence of a pre-existing regular astigmatism ranging between -1.00 to -3.00D\r\n\r\n          -  Informed consent obtained for both phacoemulsification surgery and LRI procedure\r\n\r\n          -  Study subject is agreeable to comply with the postoperative follow-up regime stated\r\n\r\n          -  Absence of any exclusion criteria\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Presence of irregular astigmatism\r\n\r\n          -  Pre-existing pterygium\r\n\r\n          -  Previous corneal / anterior segment surgery\r\n\r\n          -  Pre-existing corneal scar\r\n\r\n          -  Pre-existing corneal pathology eg keratoconus, Fuch's endothelial dystrophy, PUK, etc\r\n\r\n          -  Pre-existing glaucoma\r\n      ","sponsor":"Singapore National Eye Centre","sponsor_type":"Other","conditions":"Corneal Astigmatism","interventions":[{"intervention_type":"Procedure","name":"Procedure: Limbal relaxing incision"}],"outcomes":[{"outcome_type":"primary","measure":"Amount of surgically induced astigmatism at three months postop","time_frame":"at three months postop"},{"outcome_type":"secondary","measure":"Depth of LRI achieved at one month postop","time_frame":"at one month postop"},{"outcome_type":"secondary","measure":"Unaided visual acuity at three months postop","time_frame":"at three months postop"}]}
{"nct_id":"NCT00403520","start_date":"2006-11-30","phase":"Phase 4","enrollment":240,"brief_title":"Hippocampus Study: Comparative Effect of Donepezil 10mg/d and Placebo on Clinical and Radiological Markers","official_title":"Assessment of the Comparative Effect of Donepezil 10mg/d and Placebo on Clinical and Radiological Markers in Patients With Mild Cognitive Disorders","primary_completion_date":"2008-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-08-31","last_update":"2014-07-14","description":"The purpose of this study is to demonstrate that donepezil slows the progression of Alzheimer's disease (AD) using magnetic resonance imaging (MRI) of the brain to measure the volume of the hippocampus in patients with pre-dementia Alzheimer's disease.","other_id":"E2020-E033-415","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":50,"population":"","criteria":"\n        Inclusion Criteria (Baseline Visit (\"V0\"):\r\n\r\n        1.Men or Women 50 years old or more. 2. Patients with mild cognitive impairment (MCI) with\r\n        progressive hippocampal amnestic syndrome, isolated or associated to other cognitive\r\n        disorders defined by the Free and cued selective reminding test ( FCSRT ) with Free Recall\r\n        < or = 17 OR Total Recall < 40 , according to the Grober and Buschke procedure, modified\r\n        according to the results of PREAL study 3.Clinical Dementia Rating (CDR) = 0.5 4. General\r\n        cognition and functional performance sufficiently preserved such that a diagnosis of\r\n        Possible or Probable Alzheimer's Disease based on Diagnostic and Statistical Manual of\r\n        Mental Disorders DSM-IV criteria) cannot be made by the site physician at the time of the\r\n        screening visit. This evidence must be fully documented in the subject's study file before\r\n        the Randomization visit.\r\n\r\n        5. Outpatient with an informant person: person from his/her close circle having a regular\r\n        weekly contact with the patient and accepting to answer to assessment questionnaires.\r\n\r\n        6. Visual, hearing capacities (authorized equipment) and oral or written expression,\r\n        sufficient for the correct performance of the tests (according to the physician's opinion).\r\n\r\n        7. Patient and informant person having signed the written informed consent form.\r\n\r\n        Exclusion Criteria (Baseline Visit (\"V0\"):\r\n\r\n          1. Patients with a contraindication to MRI:\r\n\r\n               -  Pacemaker, cardiac defibrillator or neurostimulator wearers\r\n\r\n               -  Wearers of implanted material activated by an electric, magnetic or mechanical\r\n                  system\r\n\r\n               -  Wearers of haemostatic clips of intracerebral aneurysms or carotid arteries\r\n\r\n               -  Wearers of cochlear implants\r\n\r\n               -  Patients with an intraocular metallic foreign body\r\n\r\n               -  Claustrophobic patients\r\n\r\n               -  Any other contra-indication to MRI\r\n\r\n          2. Patients with an evolutive psychiatric pathology and/or unstable according to DSM-IV,\r\n             particularly:\r\n\r\n               -  Major depressive episode during the previous 2 years or recurrent depression or\r\n                  bipolar disorders according to the DSM-IV and/or score >= 12 according to the\r\n                  17-items depressive Hamilton's Scale\r\n\r\n               -  Patients presenting early hallucinations or cognitive fluctuations\r\n\r\n          3. Patients with neurological disorders:\r\n\r\n               -  Partial complex epilepsy\r\n\r\n               -  Dementia of any origin\r\n\r\n               -  Patients with Parkinson's disease\r\n\r\n          4. Any patient with a history of an intercurrent lesion found in brain imaging studies.\r\n\r\n          5. Patient presenting a major repercussion on the autonomy, assessed by Instrumental\r\n             Activities of Daily Living (IADL) Lawton score higher or equal to 2 in at least 2\r\n             items or higher than 2 in at least 1 item, confirmed by an informant person.\r\n\r\n          6. Patient having less than 14 words at the identification phase of the FCSRT (Free and\r\n             Cued Selective Reminding Test)\r\n\r\n          7. Known vitamin B12 or folates deficiency (except if replacement treatment of stable\r\n             posology since at least 6 months before selection) or known syphilis.\r\n\r\n          8. Abnormal Thyroid function (T3, T4, ultrasensitive thyroid stimulating hormone (TSH).\r\n             Euthyroid patients treated with stable doses for at least 3 months could be included.\r\n\r\n          9. Insulin dependent diabetes or diabetes not controlled by a regimen and/or oral\r\n             antidiabetics, obstructive pulmonary disease, unstable asthma, recent hematological\r\n             and/or oncological disorders (2 years).\r\n\r\n         10. Gastrointestinal, renal, hepatic, endocrine or cardiovascular clinically significant\r\n             disease. Atrioventricular block of 2nd or 3rd degree on ECG.\r\n\r\n         11. Patient with bradycardia < or = 50 beats per minute.\r\n\r\n         12. Patient with unstable hypertension (systolic blood pressure > 160 mmHg and /or\r\n             diastolic blood pressure > 95 mmHg) assessed by the investigator, the patient being\r\n             treated or not by antihypertensive drugs.\r\n\r\n         13. Patient previously treated with central cholinesterase inhibitors or memantine\r\n             whatever the duration of the treatment and the date of prescription\r\n\r\n         14. Patient treated by a non-authorized drug during the study\r\n\r\n         15. Known or suspected history (5 years) of alcoholism, or abusive drug use.\r\n\r\n         16. Patients with known hypersensitivity to donepezil chlorhydrate, to piperidine\r\n             derivatives or to one of the excipients of the drug.\r\n\r\n         17. Patients having participated in a clinical trial during the previous 3 months.\r\n\r\n        Inclusion criteria (Visit 1):\r\n\r\n          1. Patients with mild cognitive impairment (MCI) with progressive hippocampal amnestic\r\n             syndrome, isolated or associated to other cognitive disorders\r\n\r\n          2. General cognition and functional performance sufficiently preserved such that a\r\n             diagnosis of Possible or Probable Alzheimer's Disease based on clinical and\r\n             neuro-imaging findings (NINCDS-ADRDA or DSM-IV criteria) cannot be made by the site\r\n             physician at the time of the screening visit. This evidence must be fully documented\r\n             in the subject's study file.\r\n\r\n          3. Outpatient with an informant person: person from his/her close circle having a regular\r\n             weekly contact with the patient and accepting to answer to assessment questionnaires\r\n\r\n          4. Patients having performed an electrocardiogram (ECG) within the previous 6 months\r\n\r\n          5. Visual, hearing capacities (authorized equipment) and oral or written expression,\r\n             sufficient for the correct performance of the tests (according to the physician's\r\n             opinion)\r\n\r\n          6. Clinical laboratory values must be within normal limits, or if abnormal, judged\r\n             clinically insignificant by the investigator (not likely to cause cognitive impairment\r\n             or medical instability)\r\n\r\n          7. Clinical Dementia Rating (CDR - sum of the boxes) = 0.5\r\n\r\n        Exclusion criteria (Visit 1):\r\n\r\n          1. Patients with an evolutive psychiatric pathology and/or unstable according to DSM-IV,\r\n             particularly:\r\n\r\n               -  Major depressive episode ongoing or recurrent depression or bipolar disorders\r\n                  according to the DSM-IV and/or score >or = 12 according to the 17-items\r\n                  depressive Hamilton's Scale\r\n\r\n               -  Patients presenting early hallucinations or cognitive fluctuations\r\n\r\n          2. Any patient presenting with an intercurrent lesion in MRI performed at screening must\r\n             be excluded from the study, apart from minor non-progressive lesions not altering\r\n             brain morphology\r\n\r\n          3. Patients with neurological disorders :\r\n\r\n               -  Partial complex epilepsy\r\n\r\n               -  Dementia of any origin\r\n\r\n               -  Patients with Parkinson's disease\r\n\r\n          4. Patient with One or more MRI Exclusion criteria :\r\n\r\n               -  Stroke sequelae\r\n\r\n               -  More than one ischemic lacuna\r\n\r\n               -  Age related white matter changes on Flair images >Fazekas and Schmidt grade 2\r\n\r\n               -  Active ischemic lesion on Diffusion weighted Images (DWI)\r\n\r\n          5. Patient presenting a major repercussion on the autonomy, assessed by IADL Lawton score\r\n             higher or equal to 2 in at least 2 items or higher than 2 in at least 1 item,\r\n             confirmed by an informant person.\r\n\r\n          6. Known vitamin B12 or folates deficiency (except if replacement treatment of stable\r\n             posology since at least 6 months before selection) or known syphilis.\r\n\r\n          7. Abnormal Thyroid function (T3, T4, free thyroxine index, TSH). Euthyroid patients\r\n             treated with stable doses for at least 3 months could be included.\r\n\r\n          8. Insulin dependent diabetes or diabetes not controlled by a regimen and/or oral\r\n             antidiabetics, obstructive pulmonary disease, unstable asthma, recent hematological\r\n             and/or oncological disorders (<= 2 years).\r\n\r\n          9. Gastrointestinal, renal, hepatic, endocrine or cardiovascular clinically significant\r\n             disease. Atrioventricular block of 2nd or 3rd degree on ECG.\r\n\r\n         10. Patients with bradycardia <= 50.\r\n\r\n         11. Patients with unstable hypertension (systolic blood pressure > 160 mmHg and/or\r\n             diastolic blood pressure > 95mmHg) assessed by the investigator, the patient being\r\n             treated or not by anti hypertensive drugs.\r\n\r\n         12. Patient previously treated with central cholinesterase inhibitors or memantine\r\n             whatever the duration of the treatment and the date of prescription\r\n\r\n         13. Patient treated by a non-authorized drug during the study\r\n\r\n         14. Known or suspected history (<= 5 years) of alcoholism, or abusive drug use.\r\n\r\n         15. Patients with known hypersensitivity to donepezil chlorhydrate, to piperidine\r\n             derivatives or to one of the excipients of the drug.\r\n\r\n         16. Patients having participated in a clinical trial during the previous 3 months.\r\n\r\n         17. Patient treated by a non-authorized drug during the study.\r\n      ","sponsor":"Eisai Inc.","sponsor_type":"Industry","conditions":"Alzheimer's Disease","interventions":[{"intervention_type":"Drug","name":"Drug: Experimental 1","description":"Drug: Donepezil Hydrochloride 10 mg orally for 12 months"},{"intervention_type":"Drug","name":"Drug: Placebo Comparator","description":"Drug: Placebo Matching placebo orally for 12 months"}],"outcomes":[{"outcome_type":"primary","measure":"Evolution of the volume of the Hippocampi, measured by magnetic resonance imaging (MRI), between D0 and final visit (12 months ).","time_frame":"( Day 0 to 12 months or in case of premature withdrawal after 6 months period"},{"outcome_type":"secondary","measure":"Evolution of the neuropsychological scores between Day 0 and final visit.","time_frame":"Day 0 to 12 during treatment and at 18 months follow up","description":"Outcome Measure Description: Patients will perform neuropsychological and independence tests including (16 items free recall/cued recall test using the Grober-Buschke method, Mini-Mental State Examination (MMSE), Clinical Dementia Rating (CDR) sum of the boxes and Instrumental Activities of Daily Living (IADL), and will be evaluated using the Hamilton Scale."}]}
{"nct_id":"NCT00397176","start_date":"2006-11-30","phase":"Phase 1","enrollment":32,"brief_title":"Study Evaluating Safety, Tolerability, and PK of DVS SR in Healthy Japanese Women","official_title":"Ascending, Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of DVS SR Administered Orally to Healthy Japanese Female Subjects","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-02-28","last_update":"2007-12-28","description":"Safety, tolerability, and pharmacokinetics (PK) of desvenlafaxine succinate sustained release (DVS SR) in healthy Japanese female subjects.","other_id":"3151A2-1200","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"Female","minimum_age":20,"maximum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy, first-generation (born in Japan, living in the US for less than 5 years)\r\n\r\n          -  Japanese female subjects\r\n      ","sponsor":"Wyeth is now a wholly owned subsidiary of Pfizer","sponsor_type":"Industry","conditions":"Vasomotor Symptoms","interventions":[{"intervention_type":"Drug","name":"Drug: desvenlafaxine succinate sustained release (DVS SR)"}],"outcomes":[{"outcome_type":"primary","measure":"Safety, Tolerability, PK"}]}
{"nct_id":"NCT00392145","start_date":"2006-11-30","phase":"Phase 4","enrollment":226,"brief_title":"Emergency Department Rapid Intravenous Rehydration (RIVR) for Pediatric Gastroenteritis","official_title":"Emergency Department Rapid Intravenous Rehydration (RIVR) for Pediatric Gastroenteritis: A Randomized Controlled Trial","primary_completion_date":"2010-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-05-31","last_update":"2018-04-17","description":"This study will look at children with dehydration secondary to gastroenteritis requiring IV rehydration and determine whether the proportion rehydrated after two hours is greater in the children who receive rapid intravenous rehydration (RIVR) or in the children who receive standard IV rehydration.","other_id":"1000008579","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":0.24658,"maximum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Acute gastroenteritis as determined by the supervising physician.\r\n\r\n          -  Age greater than 90 days\r\n\r\n          -  Dehydrated and unable to consume sufficient oral fluids to overcome their dehydration\r\n             state\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Weight less than 5 kg or greater than 33 kg\r\n\r\n          -  Underlying disease which may limit the amount of IV fluids given,including but not\r\n             limited to: hypoalbuminemic states, renal insufficiency, heart disease requiring\r\n             pharmacotherapy or lesions that may predispose to congestive heart failure,\r\n             hypertension, chronic lung disease (excluding asthma), diabetes mellitus, severe\r\n             anemia, and chronic inflammatory disease\r\n\r\n          -  Clinical suspicion by the attending physician of myocarditis or previously undiagnosed\r\n             cardiac or renal disease.\r\n\r\n          -  History of abdominal surgery or concern regarding an acute surgical abdomen\r\n\r\n          -  Significant head, chest or abdominal trauma within the preceding 7 days\r\n\r\n          -  Bilious or bloody vomitus\r\n\r\n          -  Evidence of hemodynamic compromise (BP < 80 + 2 * age (yrs)) requiring > 20 mL/kg 0.9%\r\n             normal saline to be administered in the 1st hour\r\n\r\n          -  Bedside glucose < 2.8 mmol/L (see Section 8.3)\r\n\r\n          -  Unable to provide a telephone number or unavailable for follow-up\r\n\r\n          -  Previously enrolled in this trial\r\n      ","sponsor":"The Hospital for Sick Children","sponsor_type":"Other","conditions":"Gastroenteritis|Dehydration","interventions":[{"intervention_type":"Drug","name":"Drug: Standard IV rehydration","description":"A 20 mL/kg 0.9% normal saline bolus (maximum 999 mL) will be administered over 1 hour. This will be followed by D5-0.9% normal saline at a maintenance rate (maximum 55 mL/hr)."},{"intervention_type":"Drug","name":"Drug: Rapid intravenous rehydration (RIVR)","description":"A 60 mL/kg 0.9% normal saline bolus (maximum 999 mL) over 1 hour will be administered. This will be followed by D5-0.9% normal saline at a maintenance rate (maximum 55 mL/hr)."}],"outcomes":[{"outcome_type":"secondary","measure":"Attending physician discharge comfort level","time_frame":"Two and four hours following initiation of IV rehydration"},{"outcome_type":"primary","measure":"Rehydration criteria defined by: dehydration score ≤ 1, normal capillary refill time, normal skin turgor, normal respiratory rate","time_frame":"2 hours following the initiation of IV rehydration"},{"outcome_type":"secondary","measure":"Hospitalization","time_frame":"72 hours"},{"outcome_type":"secondary","measure":"Ability to tolerate oral rehydration","time_frame":"Measured per 2 hour time period after consuming 5 mL/kg of liquid"},{"outcome_type":"secondary","measure":"Repeat ED visit","time_frame":"72 hours"},{"outcome_type":"secondary","measure":"Time (in minutes) from initiation of IV rehydration until disposition determination","time_frame":"Determined by outcome"}]}
{"nct_id":"NCT00392548","start_date":"2006-10-31","enrollment":130,"brief_title":"URINARY VEGF Levels in GBM Patients on Radiation Treatment Protocol","official_title":"Urinary VEGF and MMP Levels in Patients Receiving Radiation Therapy for Glioblastoma Multiforme: Prospective Determination of a Predictive Value for Recurrence","study_type":"Observational","rec_status":"Unknown status","completion_date":"2006-10-31","last_update":"2006-10-26","description":"Study of the urinary vascular endothelial growth factor (VEGF) levels in patients with glioblastoma, receiving standard therapy. Hypothesis: that urinary VEGF levels can serve as a predictor of treatment response and survival.","other_id":"RTOG0611","observational_model":"Defined Population","time_perspective":"Prospective","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patient must be enrolled on an RTOG GBM study that prescribes 6000 cGy of radiation\r\n             therapy.\r\n\r\n          -  Patient must meet the eligibility requirements for the RTOG treatment study. (If the\r\n             patient is deemed retrospectively ineligible for the RTOG treatment study, the patient\r\n             will likewise be ineligible for this study.)\r\n\r\n          -  Patient must sign a study-specific informed consent for RTOG 0611 prior to study\r\n             entry.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patient not able to receive 6000 cGy of radiation therapy.\r\n      ","sponsor":"Tel-Aviv Sourasky Medical Center","sponsor_type":"Other","conditions":"Glioblastoma","interventions":{},"outcomes":{}}
{"nct_id":"NCT00389038","start_date":"2006-10-31","phase":"Phase 3","enrollment":132,"brief_title":"Pediatric Chronic Headache Trial","official_title":"Drug and Non-Drug Treatment of Pediatric Chronic Headache","primary_completion_date":"2012-08-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2012-09-30","last_update":"2011-04-25","description":"The purpose of this trial is to evaluate the efficacy of combined behavioral and pharmacological treatment on chronic daily headache in children ages 10 to 17.","other_id":"R01NS050536","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":10,"maximum_age":17,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  diagnosis of chronic daily headache based on definition of 15 or more headache days\r\n             per month measured by a prospective daily headache diary\r\n\r\n          -  females or males between the ages of 10-17\r\n\r\n          -  PedMIDAS Disability Score > 20, indicating at least moderate disruption in daily\r\n             activities\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  medication overuse as defined in the ICHD-II criteria (NSAID or other simple analgesic\r\n             on  15 days/ month for >3 months; triptan intake in any formulation  10 days/month\r\n             on a regular basis of  3 months)\r\n\r\n          -  current treatment with amitriptyline\r\n\r\n          -  no other current prophylactic antimigraine medication within a period equivalent to <\r\n             5 half-lives of that medication before entering the screening phase\r\n\r\n          -  other chronic pain condition such as juvenile primary fibromyalgia syndrome, complex\r\n             regional pain syndrome-II\r\n\r\n          -  abnormal findings on EKG\r\n\r\n          -  current or past history of severe orthostatic intolerance or severe levels of\r\n             orthostatic dysregulation (orthostatic hypotension or postural orthostatic tachycardia\r\n             syndrome)\r\n\r\n          -  significant documented developmental delay or impairments such as autism, cerebral\r\n             palsy or mental retardation\r\n\r\n          -  present or lifetime psychiatric diagnosis that meets DSM-IV criteria for bipolar\r\n             disorder, major depressive disorder or psychosis\r\n\r\n          -  PedMIDAS Disability Score of > 140, indicating need for multi-systemic therapies to\r\n             address very significant level of disability\r\n\r\n          -  youth who are pregnant, or those females who are sexually active and not using a\r\n             medically accepted form of contraception (barrier or hormonal methods) or do not agree\r\n             to be abstinent during the study\r\n\r\n          -  disallowed medications/products: opioids, antipsychotics, antimanics, barbiturates,\r\n             benzodiazepines, muscle relaxants, sedatives, tramadol\r\n      ","sponsor":"Children's Hospital Medical Center, Cincinnati","sponsor_type":"Other","conditions":"Headache","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Coping Skills Training","description":"Behavioral Treatment 1 (coping skills training)--Behavioral Treatment session 1 and 2: Doses are one session a week for 8 weeks, followed by one session a month for 2 months, followed by 1 session every three months for 1 year."},{"intervention_type":"Behavioral","name":"Behavioral: Headache Education","description":"Behavioral Treatment 2 (headache education)"},{"intervention_type":"Drug","name":"Drug: Amitriptyline","description":"Amitriptyline: up to 1 mg/kg capsule taken once daily at bedtime. Taken up to Week 20. After Week 20 medications and doses may change with standard care."}],"outcomes":[{"outcome_type":"primary","measure":"Headache diaries assess headache frequency.","time_frame":"Completed one month prior to first visit, then weekly up to Week 20, then one month prior to Month 3, 6, 9, and 12 Follow-Up Visits."},{"outcome_type":"secondary","measure":"The Child Depression Inventory.","time_frame":"Completed at Baseline, Week 20, and Months 3, 6, 9, and 12."},{"outcome_type":"secondary","measure":"The PedsQL measures the impact of chronic illness and quality of life.","time_frame":"Completed at Baseline, Week 20, and Months 3, 6, 9, and 12."},{"outcome_type":"secondary","measure":"Pediatric Migraine Disability Assessment (PedMIDAS) evaluates the impact of headaches on life activities.","time_frame":"Completed at Baseline, Week 20, and Months 3, 6, 9, and 12."}]}
{"nct_id":"NCT02313766","start_date":"2006-10-31","phase":"N/A","enrollment":150,"brief_title":"Preoxygenation With Positive Inspiratory Pressure During Induction of Anesthesia","official_title":"Randomized Controlled Trial on Preoxygenation Through Spontaneous Breathing or Non Invasive Positive Pressure Ventilation With and Without Positive End Expiratory Pressure","primary_completion_date":"2007-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-01-31","last_update":"2016-04-14","description":"Adults patients scheduled for elective surgery were randomly allocated to receive preoxygenation with spontaneous breathing, positive pressure ventilation (positive inspiratory pressure: 12 cmH2O) without PEEP, and with PEEP (positive inspiratory pressure: 12 cmH2O, PEEP: 6 cmH2O). Preoxygenation time was measured from face mask positioning to FEO2=90% (FEO2 : expired fraction of O2). After endotracheal tube placement the time until SpO2=93% (SpO2 : peripheral oxygen saturation) was measured during monitored apnoea. Patient's discomfort was recorded (visual analogue scale).","other_id":"2005-39","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  American Society of Anesthesiologists (ASA) physical status I and II\r\n\r\n          -  Scheduled surgery with general anaesthesia and oro-tracheal intubation\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  rapid sequence induction\r\n\r\n          -  anticipated difficult mask ventilation\r\n\r\n          -  anticipated difficult intubation\r\n\r\n          -  refusal to participate to the study and to sign informed consent\r\n      ","sponsor":"University Hospital, Caen","sponsor_type":"Other","conditions":"Anesthesia","interventions":[{"intervention_type":"Other","name":"Other: PPV : positive pressure ventilation","description":"Inspiratory pressure support ventilation (12 cmH2O) without PEEP"},{"intervention_type":"Other","name":"Other: PEEP : PPV + PEEP","description":"Inspiratory pressure support ventilation (12 cmH2O) with PEEP (6 cmH2O)"}],"outcomes":[{"outcome_type":"primary","measure":"Time for Preoxygenationfrom Face Mask Positioning to FEO2=90%","time_frame":"up to 5 min","description":"Time measured form face mask positioning until FEO2 reached 90% on the gas monitor"},{"outcome_type":"secondary","measure":"Time Until SpO2=93%","time_frame":"up to 10 min","description":"time until SpO2=93% after endotracheal tube placement has been confirmed"},{"outcome_type":"secondary","measure":"Discomfort of the Preoxygenation Phase Self Reported by the Patient","time_frame":"Before PACU leaving","description":"discomfort of the preoxygenation phase evaluated on a visual analogue scale (0 no discomfort - 100 maximal discomfort) just before PACU leaving"}]}
{"nct_id":"NCT00886210","start_date":"2006-10-31","phase":"N/A","enrollment":100,"brief_title":"Clinical Impact of Routine Abdominal Drainage After Laparoscopic Cholecystectomy","official_title":"Clinical Impact of Routine Abdominal Drainage After Laparoscopic Cholecystectomy. A Prospective Randomized Study","primary_completion_date":"2008-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-03-31","last_update":"2009-04-22","description":"Patients and methods: 100 patients were included in this study. They divided into two groups, group (A) with drain and group (B) without drain. The investigators recorded the effect of drainage on, postoperative pain (Po-P) using visual analogue scale VAS at 6, 24, 48 hours and 1 week postoperative nausea/vomiting at 6, 24, 48 hours postoperative, abdominal collection, hospital stay, chest complication, and postoperative body temperature.","other_id":"abdominal drainage","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":21,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  patients with gallbladder stones and laparoscopic cholecystectomy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  patients above 80 years old\r\n\r\n          -  patients with acute cholecystitis\r\n\r\n          -  patients with history of upper laparotomy\r\n\r\n          -  patients with a hemorrhagic tendency due to cirrhosis\r\n\r\n          -  patients refused to give informed consent and patients who were converted to open\r\n             cholecystectomy\r\n      ","sponsor":"Mansoura University","sponsor_type":"Other","conditions":"Abdominal Drainage|Laparoscopic Cholecystectomy|Gall Stones","interventions":[{"intervention_type":"Procedure","name":"Procedure: LC without drain","description":"Under general anesthesia, and same antibiotics (3rd generation cephalosporin). Surgery was performed using conventional four ports umbilical port, port below xiphoid and two ports below right costal margin. Pneumoperitonum at pressure 12 mmHg. In group no drain at the end of operation."},{"intervention_type":"Procedure","name":"Procedure: intra abdominal drain","description":"Under general anesthesia, and same antibiotics (3rd generation cephalosporin). Surgery was performed using conventional four ports umbilical port, port below xiphoid and two ports below right costal margin. Pneumoperitonum at pressure 12 mmHg. In group A nelton catheter (no 20) inserted at the end of operation."}],"outcomes":[{"outcome_type":"primary","measure":"pain, nausea and vomiting","time_frame":"30 days postoperative"}]}
{"nct_id":"NCT00362765","start_date":"2006-10-31","phase":"Phase 2/Phase 3","enrollment":8,"brief_title":"Fenofibrate and Metformin Insulin Sensitivity in Type 2 Diabetics Study","official_title":"Assessment of Insulin Sensitivity in Type 2 Diabetics Treated With Metformin, Fenofibrate and Their Combination.","study_type":"Interventional","rec_status":"Terminated","completion_date":"2007-07-31","last_update":"2008-08-13","description":"Double-blind, randomized placebo-controlled study in type 2 diabetes and dyslipidemic patients.Patients will be randomized to one of four treatment arms for 16 weeks: placebo, fenofibrate, metformin, or metformin and fenofibrate combination.","other_id":"C LF23-0121 05 03","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":40,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with type 2 diabetes mellitus and dyslipidemia.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Type 1 diabetes.\r\n      ","sponsor":"Solvay Pharmaceuticals","sponsor_type":"Industry","conditions":"Type 2 Diabetes|Dyslipidemia","interventions":[{"intervention_type":"Drug","name":"Drug: Fenofibrate","description":"160 mg"},{"intervention_type":"Drug","name":"Drug: Metformin","description":"2000 mg"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"Endogenous Glucose Production (EGP) and Glucose Disposal Rate (GDR) by two-step hyperinsulinemic euglycemic clamp (HEC)","time_frame":"16 weeks"},{"outcome_type":"secondary","measure":"Gluconeogenesis, Glycogenolysis, Skeletal muscle and liver fat content, Abdominal fat content, Body energy expenditure and respiratory quotient, Lipids and glycemic parameters","time_frame":"16 weeks"}]}
{"nct_id":"NCT00390884","start_date":"2006-10-31","phase":"Phase 4","enrollment":173,"brief_title":"Safety and Immunogenicity of Fluzone Vaccine in Children Who Received 2 Doses of the 2005-2006 Fluzone Formulation.","official_title":"Safety and Immunogenicity of Fluzone Influenza Virus Vaccine (2006-2007 Formulation) Among Healthy Children Immunized in Fall 2005 With Fluzone Vaccine or Placebo","primary_completion_date":"2007-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-09-30","last_update":"2016-04-14","description":"To compare the groups with respect to influenza immune responses following Dose 1 of Fluzone vaccine (2006-2007 formulation).","other_id":"GRC29","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":0.91667,"maximum_age":1.16667,"population":"","criteria":"\n        Inclusion Criteria :\r\n\r\n          -  Previously enrolled in study GRC28 and received 2 vaccinations of the assigned lot.\r\n\r\n          -  Considered to be in good health on the basis of reported medical history and\r\n             history-directed physical evaluation.\r\n\r\n          -  Available for the duration of the study.\r\n\r\n          -  Parent/legal representative willing and able to provide informed consent.\r\n\r\n          -  Parent/legal representative able to attend all scheduled visits and comply with all\r\n             trial procedures.\r\n\r\n          -  Parent/legal representative willing to permit venipuncture for purposes of collecting\r\n             a blood sample.\r\n\r\n        Exclusion Criteria :\r\n\r\n          -  Receipt of any vaccine within the past 7 days (subjects may be deferred until after\r\n             the seven days has passed.)\r\n\r\n          -  Reported allergy to egg proteins, chicken proteins or any other constituent of the\r\n             vaccine.\r\n\r\n          -  Ever received any influenza vaccine, other than at Visits 1 and 2 of study GRC28, or\r\n             known to have ever been diagnosed with laboratory-confirmed influenza.\r\n\r\n          -  An acute illness with fever (rectal temperature  100.4F [38.0C]) in the 72 hours\r\n             preceding enrollment in the trial (defer enrollment).\r\n\r\n          -  Known bleeding disorder.\r\n\r\n          -  Participation in any other interventional clinical trial within 30 days prior to\r\n             enrollment, or planned participation in another interventional clinical trial prior to\r\n             termination of the subject's participation in the study.\r\n\r\n          -  Known or suspected impairment of immunologic function or receipt of immunosuppressive\r\n             therapy or immunoglobulin since birth.\r\n\r\n          -  Personal or immediate family history of congenital immune deficiency.\r\n\r\n          -  Developmental delay, neurologic disorder, or seizure disorder.\r\n\r\n          -  Chronic medical, congenital, or developmental disorder that, in the opinion of the\r\n             investigator, could interfere with trial conduct or completion.\r\n\r\n          -  Known Human Immunodeficiency Virus (HIV)-positive mother or Hepatitis B surface\r\n             antigen (HBsAg)-positive mother.\r\n\r\n          -  Known HIV, Hepatitis B, or Hepatitis C infection.\r\n\r\n          -  Administration of immune globulin or other blood products within the last three\r\n             months, or injected or oral corticosteroids or other immunomodulator therapy within\r\n             six weeks of the study vaccine. Individuals on a tapering dose schedule of oral\r\n             steroids lasting < 7 days may be included in the trial as long as they have not\r\n             received more than one course within the last two weeks prior to enrollment.\r\n\r\n          -  Prior personal history of Guillain-Barr syndrome.\r\n\r\n          -  Any condition that, in the opinion of the investigator, would pose a health risk to\r\n             the subject or interfere with the evaluation of the vaccine.\r\n      ","sponsor":"Sanofi Pasteur, a Sanofi Company","sponsor_type":"Industry","conditions":"Influenza","interventions":[{"intervention_type":"Biological","name":"Biological: Influenza Virus Vaccine, Fluzone","description":"0.25 mL, Intramuscular"},{"intervention_type":"Biological","name":"Biological: Influenza Virus Vaccine, Fluzone","description":"0.25 mL, Intramuscular"}],"outcomes":[{"outcome_type":"secondary","measure":"Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone®","time_frame":"Day 28 Post-vaccination","description":"Antibodies against Influenza virus in Fluzone® Vaccine determined by the Hemagglutination inhibition (HAI) assay method."},{"outcome_type":"primary","measure":"Percentage of Seroprotected Participants Post-vaccination With Fluzone®","time_frame":"Day 28 Post-vaccination","description":"Seroprotection was defined as a Post-vaccination Hemagglutination Inhibition titer of greater than or equal to 1:40."},{"outcome_type":"other","measure":"Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone®","time_frame":"Days 0-7 Post-vaccination","description":"Solicited injection site: tenderness, erythema, and swelling; Solicited systemic reactions: fever, vomiting, abnormal crying, drowsiness, appetite loss, and irritability, after each vaccination"}]}
{"nct_id":"NCT02535741","start_date":"2006-10-31","phase":"N/A","enrollment":168,"brief_title":"Clinical Outcome Study for the Triathlon Cruciate Retaining (CR) Total Knee","official_title":"Clinical Outcome Study for the Triathlon CR Total Knee","primary_completion_date":"2013-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-05-31","last_update":"2018-06-26","description":"An open label, post-market, non-randomised, historical controlled, multi-centre study of the outcomes of the Triathlon Cruciate Retaining (CR) Total Knee System.","other_id":"K-S-016","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":21,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patients willing to sign the Ethic Commission approved, study specific Informed\r\n             Patient Consent Form.\r\n\r\n          2. Patients willing and able to comply with scheduled postoperative clinical and\r\n             radiographic evaluations and rehabilitation.\r\n\r\n          3. Male or non-pregnant female between the ages of 21-80 years of age at the time of\r\n             surgery.\r\n\r\n          4. Patients requiring a primary total knee replacement.\r\n\r\n          5. Patients with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or\r\n             avascular necrosis (AVN).\r\n\r\n          6. Patients with intact collateral ligaments.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients with inflammatory arthritis.\r\n\r\n          2. Patients that are morbidly obese, body mass index (BMI) > 40.\r\n\r\n          3. Patients with a history of total / unicompartmental reconstruction of the affected\r\n             joint.\r\n\r\n          4. Patients that have had a high tibial osteotomy or femoral osteotomy.\r\n\r\n          5. Patients with neuromuscular or neurosensory deficiency, which would limit the ability\r\n             to assess the performance of the device.\r\n\r\n          6. Patients with a systemic or metabolic disorder leading to progressive bone\r\n             deterioration.\r\n\r\n          7. Patients that are immunologically compromised, or receiving chronic steroids (>30 days\r\n             duration).\r\n\r\n          8. Patients bone stock is compromised by disease or infection which cannot provide\r\n             adequate support and/or fixation to the prosthesis.\r\n\r\n          9. Patients with a knee fusion to the affected joint.\r\n\r\n         10. Patients with an active or suspected latent infection in or about the knee joint.\r\n\r\n         11. Patients with a history of total joint replacement on the opposite knee within less\r\n             than 1 year.\r\n\r\n         12. Patients requiring bilateral total knee replacement.\r\n      ","sponsor":"Stryker European Operations BV","sponsor_type":"Industry","conditions":"Total Knee Arthroplasty","interventions":[{"intervention_type":"Device","name":"Device: Triathlon CR Total Knee System","description":"Primary total knee replacement"}],"outcomes":[{"outcome_type":"primary","measure":"Mean Triathlon CR Active Range of Motion (ROM)","time_frame":"2 years follow-up","description":"Comparison of the active ROM values for patients receiving the Triathlon CR Total Knee System with historical active ROM values of the Scorpio CR Total Knee System, a control group by literature review at 2 years post Total Knee Arthroplasty. See Chaudhary R, et al 2008 JBJS included for historical control data."},{"outcome_type":"secondary","measure":"Investigation of Patient Outcome With Radiographic Analysis","time_frame":"Pre-operative, 3 months, 1, 2 and 5 years follow-up","description":"Plain radiographs will be obtained for assessment of fixation of the device."},{"outcome_type":"secondary","measure":"Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)","time_frame":"Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up","description":"The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, Range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as \"excellent,\" \"good,\" \"fair,\" or \"poor,\" a higher value represents a better outcome."},{"outcome_type":"secondary","measure":"Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire","time_frame":"Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up","description":"The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical (PSC) and mental status component (MCS) score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state."},{"outcome_type":"secondary","measure":"Investigation of Clinical Performance and Patient Outcome With the Western Ontario McMaster Osteoarthritis Index (WOMAC) Patient Questionnaire","time_frame":"Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up","description":"The WOMAC collects information specific to osteoarthritis outcomes. The questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and physical findings. Pain is scored from 0 to 100 for each set of factors, with 0 indicating no pain and 100 indicating extreme pain. Total WOMAC scores range from 0 to 300. Lower values represent better outcomes."}]}
{"nct_id":"NCT00321711","start_date":"2006-10-01","phase":"Phase 2","enrollment":69,"brief_title":"Determination of Safe and Effective Dose of Romiplostim (AMG 531) in Subjects With Myelodysplastic Syndrome (MDS)Receiving Hypomethylating Agents","official_title":"A Randomized, Double Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of Romiplostim (AMG 531) Treatment of Subjects With Low or Intermediate Risk Myelodysplastic Syndrome (MDS) Receiving Hypomethylating Agents","primary_completion_date":"2009-10-19","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-10-19","last_update":"2018-10-17","description":"The purpose of this study is to evaluate the effect of Romiplostim (AMG 531) on the incidence of clinically significant thrombocytopenic events (grade 3 or 4 and/or receipt of platelet transfusions) in subjects with low or intermediate risk Myelodysplastic Syndrome (MDS) receiving hypomethylating agents. It is hypothesized that Romiplostim administration, at the appropriate dose and schedule, will result in reduction in the incidence of clinically significant thrombocytopenic events in low or intermediate risk MDS subjects receiving hypomethylating agents.","other_id":"20050232","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria: - Diagnosis of MDS by bone marrow biopsy based on the World Health\r\n        Organization (WHO) classification - Low, Intermediate-1 or Intermediate-2 risk category MDS\r\n        using the IPSS (International Prognostic Scoring System) - Planned to receive either\r\n        azacytidine 75 mg/m2 by subcutaneous administration each day for 7 days or decitabine 20\r\n        mg/m2 by intravenous administration each day for 5 days for at least 4 cycles Exclusion\r\n        Criteria:\r\n\r\n          -  Prior exposure to >3 cycles hypomethylating agents\r\n\r\n          -  Prior history of leukemia or aplastic anemia\r\n\r\n          -  Prior history of bone marrow transplantation\r\n\r\n          -  Prior malignancy (other than in situ cervical cancer or basal cell cancer of the skin)\r\n             unless treated with curative intent and without evidence of disease for  3 years\r\n             before randomization\r\n\r\n          -  Active or uncontrolled infections\r\n\r\n          -  Unstable angina, congestive heart failure [NYHA (New York Heart Association) > class\r\n             II], uncontrolled hypertension [diastolic > 100 mmHg], uncontrolled cardiac\r\n             arrhythmia, or recent (within 1 year) myocardial infarction\r\n\r\n          -  History of arterial thrombosis ( eg, stroke or transient ischemic attack) in the past\r\n             year\r\n\r\n          -  History of venous thrombosis that currently requires anti-coagulation therapy\r\n\r\n          -  Received IL-11 within 4 weeks of screening\r\n\r\n          -  Less than 4 weeks since receipt of any therapeutic drug or device that is not FDA\r\n             approved for any indication\r\n\r\n          -  Have previously received any other thrombopoietic growth factor\r\n      ","sponsor":"Amgen","sponsor_type":"Industry","conditions":"MDS|Myelodysplastic Syndromes|Thrombocytopenia","interventions":[{"intervention_type":"Drug","name":"Drug: Placebo","description":"Subjects in the control group will receive a placebo subcutaneous injection on a weekly basis during the 4 cycle treatment period."},{"intervention_type":"Biological","name":"Biological: AMG 531 (Romiplostim)","description":"AMG 531 (Romiplostim) will be administered weekly by subcutaneous injection at a dose of 500 or 750 g during Part A and 750 g during Part B for the 4 cycle treatment period, depending on randomization."},{"intervention_type":"Drug","name":"Drug: Azacitidine","description":"hypomethylating agent"},{"intervention_type":"Drug","name":"Drug: Decitabine","description":"hypomethylating agent"}],"outcomes":[{"outcome_type":"primary","measure":"Occurrence of a Clinically Significant Thrombocytopenic Event","time_frame":"Treatment period (up to 20 weeks)","description":"Occurrence of a clinically significant thrombocytopenic event within the participant, defined as any platelet count obtained from day 15 of cycle 1 through the end of the interim follow-up visit that was less than 50 x 10^9/L or receipt of platelet transfusions at any time through the interim follow-up visit."},{"outcome_type":"secondary","measure":"Hypomethylating Agent Dose Reduction and Delay Due to Thrombocytopenia","time_frame":"Treatment period (up to 20 weeks)","description":"Occurrence of hypomethylating agent dose reduction and delay due to thrombocytopenia"},{"outcome_type":"secondary","measure":"Achieving an Overall Response (Complete or Partial Response, CR or PR) at the End of the Treatment Period","time_frame":"Treatment period (up to 20 weeks)","description":"CR = decrease in bone marrow blast (≤5%) and improvement in peripheral blood counts (Hgb ≥ 11 g/dL, platelets ≥ 100x10^9/L, neutrophils ≥ 1x10^9/L, peripheral blasts=0%). PR = improvement in peripheral blood counts plus a decrease in bone marrow blasts ≥50% but not ≤5, or decrease in International Prognostic Scoring System score."},{"outcome_type":"secondary","measure":"Platelet Transfusion","time_frame":"Study day 1 through the interim follow-up visit (up to 20 weeks)","description":"Occurrence of one or more platelet transfusions from study day 1 through the interim follow-up visit (16 weeks)"}]}
{"nct_id":"NCT00395460","start_date":"2006-09-30","phase":"Phase 3","enrollment":147,"brief_title":"Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Brain or Spine Diseases in Chinese Patients","official_title":"A Single-blind, Multicenter, Randomized, Phase III Study of the Efficacy and Safety of Gadavist (1.0 M) in Comparison With Magnevist (0.5 M) as Contrast Agent for Enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) Lesions in Chinese Patients","primary_completion_date":"2007-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-04-30","last_update":"2015-06-08","description":"The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of brain or spine diseases in patients of Chinese origin.","other_id":"91536","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Diagnostic","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Chinese origin, with known or suspected brain or spine diseases\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnancy\r\n\r\n          -  Lactation\r\n\r\n          -  Conditions interfering with MRI\r\n\r\n          -  Allergy to any contrast agent or any drugs\r\n\r\n          -  Participation in other trial\r\n\r\n          -  Require emergency treatment\r\n\r\n          -  Severely impaired liver and kidney functions\r\n      ","sponsor":"Bayer","sponsor_type":"Industry","conditions":"Central Nervous System Diseases","interventions":[{"intervention_type":"Drug","name":"Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)","description":"1,0M, intra venous injection at a dose of 0,1 ml/kg BW (= 0,1 mmol Gd/kg BW)"},{"intervention_type":"Drug","name":"Drug: Magnevist","description":"0,5M, intra venous injection at a dose of 0,2 ml/kg BW (= 0,1 mmol Gd/kg BW)"}],"outcomes":[{"outcome_type":"primary","measure":"Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast Magnetic Resonance Imaging (MRI) Scan of Central Nervous System (CNS) Lesions","time_frame":"Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)","description":"CNR = (signal intensity [SI] lesion - SI normal tissue) / standard deviation (SD) background. SI lesion is the signal intensity in the lesion, SI normal tissue is the signal intensity in the normal tissue, and SD background is the standard deviation of the background noise. The signal intensity (SI) on the pre-contrast and on the post-contrast MR scans was to be measured in the enhanced lesion, normal tissue and background."},{"outcome_type":"secondary","measure":"Change in Number of Detected Lesions From Pre- to Post-contrast MRI Scan","time_frame":"Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)","description":"The number of lesions in the magnetic resonance scans was recorded before and after injection of contrast agent for the investigators and all 3 blinded readers (reader 2, reader 3 and reader 4)."},{"outcome_type":"secondary","measure":"Change in Diagnostic Confidence From Pre- to Post-contrast Magnetic Resonance Imaging by Treatment","time_frame":"Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)","description":"The change in diagnostic confidence was assessed based on post-contrast compared to pre-contrast scans as \"improved\", \"unchanged\" or \"worsened\" for the investigators and all 3 blinded readers (reader 2, reader 3 and reader 4)."},{"outcome_type":"secondary","measure":"Change in Lesion Contrast Enhancement From Pre- to Post-contrast MRI","time_frame":"Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)","description":"The degree of contrast enhancement was recorded on a 4-point scale as follows: 1 = No: lesion is not enhanced. 2 = Moderate: lesion is weakly enhanced. 3 = Good: lesion is clearly enhanced. 4 = Excellent: lesion is clearly and brightly enhanced. In case of more than one lesion, the lesion with maximum enhancement was to be assessed. The change in lesion contrast enhancement was assessed based on post-contrast in comparison to pre-contrast scans for the investigators and all 3 blinded readers (reader 2, reader 3 and reader 4)."},{"outcome_type":"secondary","measure":"Change in Lesion Delineation Between Pre- and Post-contrast MRI Scan of CNS Lesions","time_frame":"Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)","description":"Lesion delineation was recorded on a 4-point scale as follows: 1 = None: no or unclear delineation of the boundary between lesion and surrounding tissue; 2 = Moderate: some aspects of border delineation covered; 3 = Good: almost clear delineation, but not complete on relevant slices; 4 = Excellent: sharp and complete delineation. In case of more than one lesion, the lesion with maximum enhancement was assessed. Change in lesion delineation was assessed based on post-contrast in comparison to pre-contrast scans for investigators and all 3 blinded readers (reader 2, reader 3 and reader 4)."},{"outcome_type":"other","measure":"Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast MRI Scan of CNS Lesions in Participants With Malignant Brain Tumor(s) / Brain Metastases","time_frame":"Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)","description":"CNR = (SI lesion - SI normal tissue) / SD background. SI lesion is the signal intensity in the lesion, SI normal tissue is the signal intensity in the normal tissue, and SD background is the standard deviation of the background noise. The signal intensity (SI) on the pre-contrast and on the post-contrast MR scans was to be measured in the enhanced lesion, normal tissue and background."},{"outcome_type":"other","measure":"Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast MRI Scan of Participants With CNS Lesions Other Than Primary Malignant Brain Tumor(s) / Brain Metastases","time_frame":"Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)","description":"CNR = (SI lesion - SI normal tissue) / SD background. SI lesion is the signal intensity in the lesion, SI normal tissue is the signal intensity in the normal tissue, and SD background is the standard deviation of the background noise. The signal intensity (SI) on the pre-contrast and on the post-contrast MR scans was to be measured in the enhanced lesion, normal tissue and background."},{"outcome_type":"other","measure":"Change in Number of Detected Lesions From Pre- to Post-contrast MRI Scan of CNS Lesions in Participants With Malignant Brain Tumor(s) / Brain Metastases","time_frame":"Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)","description":"Investigators and blinded readers (reader 2, 3 and 4) were to record the number of lesions in the magnetic resonance scans before and after injection of contrast agent."},{"outcome_type":"other","measure":"Change in Number of Detected Lesions From Pre- to Post-contrast MRI Scan of Participants With CNS Lesions Other Than Primary Malignant Brain Tumor(s) / Brain Metastases","time_frame":"Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)","description":"Investigators and blinded readers (reader 2, 3 and 4= were to record the number of lesions in the magnetic resonance scans before and after injection of contrast agent."}]}
{"nct_id":"NCT00380588","start_date":"2006-09-30","phase":"Phase 2","enrollment":84,"brief_title":"Randomized Phase 2 Study With Gemcitabine Alone and Combination Therapy for Patients With Advanced Biliary Tract Cancer","official_title":"A Randomized Study of Gemcitabine/Cisplatin Versus Single-Agent Gemcitabine in Patients With Biliary Tract Cancer","primary_completion_date":"2008-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-10-31","last_update":"2009-11-20","description":"To investigate efficacy and safety of gemcitabine combined with cisplatin and of gemcitabine alone by comparison in patients with advanced biliary tract cancer","other_id":"10298","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histological or cytological diagnosis of biliary tract cancer\r\n\r\n          -  Measurable disease must be at least one lesion\r\n\r\n          -  Chemotherapy-nave\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\r\n\r\n          -  Estimated life expectancy no less than 3 months\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  radiological or clinical evidence of pulmonary fibrosis or interstitial pneumonia\r\n      ","sponsor":"Eli Lilly and Company","sponsor_type":"Industry","conditions":"Biliary Tract Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: gemcitabine","description":"1000 milligrams per square meter (mg/m2), intravenous (IV)"},{"intervention_type":"Drug","name":"Drug: cisplatin","description":"25 milligrams per square meter (mg/m2), intravenous (IV)"}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of Patients Alive at 1 Year (1-Year Survival Rate)","time_frame":"1 year","description":"Percentage of patients alive at 1 year."},{"outcome_type":"secondary","measure":"Tumor Response","time_frame":"baseline to measured progressive disease (up to 2 years)","description":"Response Evaluation Criteria In Solid Tumors - define when cancer patients improve (\"respond\"), stay the same (\"stabilize\"), or worsen (\"progression\") during treatments. Complete response (CR) = disappearance of all target lesions; Partial Response (PR) = 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD) = small changes that do not meet above criteria."},{"outcome_type":"secondary","measure":"Progression Free Survival","time_frame":"baseline to measured progressive disease (up to 2 years)","description":"The period from study entry until disease progression, death or date of last contact."},{"outcome_type":"other","measure":"Survival Time","time_frame":"baseline to date of death due to any cause (up to 2 years)","description":"Data of patients lost to follow-up were censored at the last date of confirmation of their survival."}]}
{"nct_id":"NCT01156805","start_date":"2006-09-30","phase":"N/A","enrollment":509,"brief_title":"Assessment of an School-based Intervention in Eating Habits and Physical Activity in Schoolchildren: the AVall Study","official_title":"Assessment of an School-based Intervention in Eating Habits and Physical Activity in Schoolchildren: the AVall Study.","primary_completion_date":"2008-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-09-30","last_update":"2020-08-17","description":"The objective of the study is to evaluate the efficacy of an intervention on food habits and physical activity in school-age children.","other_id":"AVALL","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":5,"maximum_age":6,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Children born in 2000 who attended schools in Granollers City\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Schoolchildren who need special diet for metabolic or digestive disorder, physical\r\n             activity incapacity, no family acceptance or attendance to school was discontinued\r\n      ","sponsor":"Hospital de Granollers","sponsor_type":"Other","conditions":"Obesity|Food Habits|Physical Activity","interventions":[{"intervention_type":"Other","name":"Other: Educational program","description":"The intervention consisted of the promotion of healthy eating habits and physical activity by means of the educational methodology Investigation, Vision, Action and Change (IVAC). At the beginning and at the end of 1st phase of the study (2006 and 2008) the weight and height of each child was measured in situ, while the families were given a self-report physical activity questionnaire and the Krece Plus quick test"}],"outcomes":[{"outcome_type":"primary","measure":"Anthropometric Variables","time_frame":"every two years","description":"BMI progression in the intervention and the control group. Secondary outcomes measured in this study were changes in eating habits and in physical activity."},{"outcome_type":"secondary","measure":"Height","time_frame":"every two years"},{"outcome_type":"secondary","measure":"Father's Height","time_frame":"every two years"},{"outcome_type":"secondary","measure":"Mother's Height","time_frame":"every two years"}]}
{"nct_id":"NCT00383526","start_date":"2006-09-30","phase":"Phase 3","enrollment":3707,"brief_title":"Study of Inactivated, Split-Virion Influenza Vaccine Compared With the Reference Vaccine Vaxigrip in the Elderly","primary_completion_date":"2009-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-09-30","last_update":"2014-01-14","description":"Vaccination against influenza is a high priority for the elderly population who present the highest morbidity and mortality rate. However, due to their weak antibody response an improvement of the immune response to influenza vaccination remains an unmet medical need. The purpose of an investigational influenza vaccine candidate administered by an alternate route is to improve immune responses to the vaccine in the elderly population, which could provide additional reductions in influenza-associated morbidity and mortality in this population. Primary Objective: To demonstrate that the investigational vaccine induces a better immunogenicity than the reference vaccine in terms of seroprotection rate after the first vaccination. Secondary Objectives: Immunogenicity: To describe the antibody persistence induced by both vaccines at 3, 6, and 12 months after the first vaccination in a subset of subjects. To describe the immunogenicity of the investigational vaccine after each vaccination using parameters defined in the European Medicines Agency (EMEA) Note for Guidance (CPMP/BWP/214/96) specific to elderly subjects. Safety: To demonstrate the tolerance of the investigational vaccine after the first vaccination, in terms of pre-defined solicited systemic reactions. To describe the safety profile after each vaccination. To describe the effect of repetitive injections on the safety profile.","other_id":"GID17","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Aged over 60 years on the day of inclusion.\r\n\r\n          -  Informed Consent Form signed.\r\n\r\n          -  Able to attend all scheduled visits and to comply with all trial procedures.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Systemic hypersensitivity to egg proteins, chick proteins, or any of the vaccine\r\n             components, in particular, neomycin, formaldehyde, and octoxinol 9, or history of a\r\n             life-threatening reaction to the trial vaccine or a vaccine containing the same\r\n             substances.\r\n\r\n          -  Febrile illness (oral temperature  37.5C or rectal equivalent temperature  38.0C)\r\n             on the day of inclusion.\r\n\r\n          -  Participation in another clinical trial in the four weeks preceding the first trial\r\n             vaccination.\r\n\r\n          -  Planned participation in another clinical trial during the present trial period.\r\n\r\n          -  Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer\r\n             chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic\r\n             corticosteroids therapy.\r\n\r\n          -  Unstable chronic illness (defined as illness requiring hospitalization or a clinically\r\n             significant change in medication in the 12 weeks prior to inclusion) at a stage that\r\n             could interfere with trial conduct or completion.\r\n\r\n          -  Current abuse of alcohol or drug addiction that may interfere with the subject's\r\n             ability to comply with trial procedures.\r\n\r\n          -  Blood or blood-derived products received in the past 3 months.\r\n\r\n          -  Any vaccination in the 4 weeks preceding the first trial vaccination.\r\n\r\n          -  Vaccination planned in the 4 weeks following the first trial vaccination.\r\n\r\n          -  Previous vaccination against influenza (in the previous 6 months) with the trial\r\n             vaccine or another vaccine.\r\n\r\n          -  Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.\r\n\r\n          -  Subject deprived of freedom by an administrative or court order, or in an emergency\r\n             setting, or hospitalized without his/her consent.\r\n      ","sponsor":"Sanofi Pasteur, a Sanofi Company","sponsor_type":"Industry","conditions":"Orthomyxoviridae Infection|Influenza|Myxovirus Infection","interventions":[{"intervention_type":"Biological","name":"Biological: Inactivated, split-virion influenza vaccine","description":"Vaccine"},{"intervention_type":"Biological","name":"Biological: Inactivated, split-virion influenza vaccine","description":"Vaccine"}],"outcomes":[{"outcome_type":"primary","measure":"To provide information concerning the immunogenicity of Inactivated, Split-Virion Influenza vaccine","time_frame":"21 days post-vaccination"},{"outcome_type":"secondary","measure":"To provide information concerning the safety of Inactivated, Split-Virion Influenza vaccine","time_frame":"Entire study period"}]}
{"nct_id":"NCT02182323","start_date":"2006-09-30","phase":"Phase 1","enrollment":74,"brief_title":"Safety, Tolerance, and Pharmacokinetics of Single Oral Doses of BI 201335 NA and Bioavailability in Healthy Male Subjects","official_title":"Safety, Tolerance, and Pharmacokinetics of Single Oral Doses of 4 mg, 16 mg, 48 mg, 120 mg, 240 mg, 480 mg, 800 mg, and 1200 mg BI 201335 NA (PEG 400/TRIS/Meglumine/Water Solution) in Healthy Male Subjects, in a Randomised Single Blind, Placebo Controlled Rising Dose Study, Followed With an Open-label Intra-subject Two-stage Crossover Pilot Bioavailability Comparison of 480 mg BI 201335 NA in a PEG 400/TRIS/Meglumine/Water Solution Coadministered With Food","primary_completion_date":"2006-12-31","study_type":"Interventional","rec_status":"Completed","last_update":"2014-07-18","description":"The objective of this study was to investigate the safety, tolerability, and pharmacokinetics of BI 201335 NA following administration of single rising doses from 4 mg to 1200 mg. In addition, the food effect on the bioavailability of BI 201335 NA (480 mg) was investigated.","other_id":"1220.3","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy males according to the following criteria: Based upon a complete medical\r\n             history, including the physical examination, vital signs (Blood Pressure (BP), Pulse\r\n             Rate (PR)), 12-lead ECG (electrocardiogram), clinical laboratory tests\r\n\r\n          -  Age 18 and Age 50 years\r\n\r\n          -  BMI 18.5 and BMI 29.9 kg/m2 (Body Mass Index)\r\n\r\n          -  Signed and dated written informed consent prior to admission to the study in\r\n             accordance with GCP (Good Clinical Practice) and the local legislation\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any finding of the medical examination (including BP, PR and ECG) deviating from\r\n             normal and of clinical relevance\r\n\r\n          -  Any evidence of a clinically relevant concomitant disease\r\n\r\n          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,\r\n             immunological or hormonal disorders\r\n\r\n          -  Prior history of jaundice\r\n\r\n          -  Surgery of the gastrointestinal tract (except appendectomy)\r\n\r\n          -  Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or\r\n             neurological disorders\r\n\r\n          -  History of relevant orthostatic hypotension, fainting spells or blackouts\r\n\r\n          -  Chronic or relevant acute infections\r\n\r\n          -  History of relevant allergy/hypersensitivity (including allergy to drug or its\r\n             excipients)\r\n\r\n          -  Intake of drugs with a long half-life (> 24 hours) within at least one month or less\r\n             than 10 half-lives of the respective drug prior to administration or during the trial\r\n\r\n          -  Use of drugs which might reasonably influence the results of the trial or that prolong\r\n             the QT/QTc interval based on the knowledge at the time of protocol preparation within\r\n             10 days prior to administration or during the trial\r\n\r\n          -  Participation in another trial with an investigational drug within two months prior to\r\n             administration or during the trial\r\n\r\n          -  Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)\r\n\r\n          -  Inability to refrain from smoking alcohol and on trial days\r\n\r\n          -  Alcohol abuse (more than 60 g/day)\r\n\r\n          -  Drug abuse\r\n\r\n          -  Blood donation (more than 100 mL within four weeks prior to administration or during\r\n             the trial)\r\n\r\n          -  Excessive physical activities (within one week prior to administration or during the\r\n             trial)\r\n\r\n          -  Any laboratory value outside the reference range that is of clinical relevance\r\n\r\n          -  Inability to comply with dietary regimen of trial site\r\n\r\n          -  A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a\r\n             QTc interval >450 ms)\r\n\r\n          -  A history of additional risk factors for TdP (torsade de pointes) (e.g., heart\r\n             failure, hypokalemia, family history of Long QT Syndrome)\r\n      ","sponsor":"Boehringer Ingelheim","sponsor_type":"Industry","conditions":"Healthy","interventions":[{"intervention_type":"Drug","name":"Drug: BI 201335 NA"},{"intervention_type":"Drug","name":"Drug: Placebo solution"}],"outcomes":[{"outcome_type":"primary","measure":"Number of patients with abnormal findings in physical examination","time_frame":"up to 12 days"},{"outcome_type":"primary","measure":"Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate)","time_frame":"up to 12 days"},{"outcome_type":"primary","measure":"Number of patients with abnormal findings in 12-lead ECG (electrocardiogram)","time_frame":"up to 12 days"},{"outcome_type":"primary","measure":"Number of patients with abnormal changes in laboratory tests (haematology, clinical chemistry and urinalysis)","time_frame":"up to 12 days"},{"outcome_type":"primary","measure":"Number of patients with adverse events","time_frame":"up to 12 days"},{"outcome_type":"primary","measure":"Assessment of tolerability by investigator on a 4-point scale","time_frame":"within 7 days after last trial procedure"},{"outcome_type":"secondary","measure":"Cmax (maximum concentration of the analyte in plasma)","time_frame":"Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60, 72, 84, 96 hours post-dose"},{"outcome_type":"secondary","measure":"tmax (time from dosing to maximum concentration)","time_frame":"Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60, 72, 84, 96 hours post-dose"},{"outcome_type":"secondary","measure":"AUC0-infinity (area under the concentration time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)","time_frame":"Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60, 72, 84, 96 hours post-dose"},{"outcome_type":"secondary","measure":"AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)","time_frame":"Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60, 72, 84, 96 hours post-dose"},{"outcome_type":"secondary","measure":"λz (terminal elimination rate constant in plasma)","time_frame":"Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60, 72, 84, 96 hours post-dose"},{"outcome_type":"secondary","measure":"t1/2 (terminal half-life of the analyte in plasma)","time_frame":"Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60, 72, 84, 96 hours post-dose"},{"outcome_type":"secondary","measure":"MRTpo (Mean residence time of the analyte in the body after oral administration)","time_frame":"Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60, 72, 84, 96 hours post-dose"},{"outcome_type":"secondary","measure":"CL/F (apparent clearance of the analyte in the plasma after oral administration)","time_frame":"Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60, 72, 84, 96 hours post-dose"},{"outcome_type":"secondary","measure":"Vz/F (apparent volume of distribution during the terminal phase λz following an oral dose)","time_frame":"Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48, 60, 72, 84, 96 hours post-dose"},{"outcome_type":"secondary","measure":"Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2)","time_frame":"Pre-dose and 0-4, 4-12, 12-24, 24-48 hours post-dose in the single rising dose phase"},{"outcome_type":"secondary","measure":"fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)","time_frame":"Pre-dose and 0-4, 4-12, 12-24, 24-48 hours post-dose in the single rising dose phase"},{"outcome_type":"secondary","measure":"CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)","time_frame":"Pre-dose and 0-4, 4-12, 12-24, 24-48 hours post-dose in the single rising dose phase"}]}
{"nct_id":"NCT01233895","start_date":"2006-09-30","phase":"Phase 1","enrollment":26,"brief_title":"Study of AVE1642 Anti-IGF1R Monoclonal Antibody in Patients With Advanced Multiple Myeloma","official_title":"Open Label Study of the Anti Insulin-like Growth Factor 1 Receptor (IGF-1R) Monoclonal Antibody, AVE1642, as Single Agent (Dose Escalation, Part 1) and in Combination With Velcade (Combination, Part 2) in Patients With Recurrent, Refractory Multiple Myeloma (MM)","primary_completion_date":"2008-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-09-30","last_update":"2010-11-03","description":"Primary Objectives: Study Part 1: Determine the selected dose of AVE1642 administered every 3 weeks based on pharmacokinetic (PK) (Clearance of AVE1642), pharmacodynamic (PD) (insulin-like growth factor 1 [IGF-1] serum level) parameters, and eventual dose limiting toxicities (DLTs) in patients with recurrent, refractory multiple myeloma (MM). Study Part 2: Assess the safety of the combination of the selected dose of AVE1642 with the recommended dose of Velcade. Secondary Objectives : Study Part 1: - To assess the safety profile: type, incidence and intensity of drug related adverse events (AEs) - To assess the biological activity of AVE1642 (saturation of the receptors and down-regulation) on malignant plasma cells and on peripheral blood mononuclear cells (PBMC) and granulocytes - To assess the biological activity of AVE1642 on the signalization pathway of the IGF-1 system (phosphorylated akt [pAkt], phosphorylated erk [pErk]) on malignant plasma cells when technically possible - To define PK profile of AVE1642, and its PD effects on serum IGF 1, GF 2 and IGFBP-3 - To assess clinical efficacy (complete response [CR], partial response [PR], minimal response [MR] and stabilization) based on the European group for Blood and Marrow Transplantation (EBMT) criteria, when possible - To assess potential immunogenicity by detection of human antihumanized antibodies (HAHA) anti-AVE1642 Study Part 2: - To detect any PK or PD interaction between AVE1642 and Velcade - To assess clinical efficacy (CR, PR, MR, no change [NC]) according to EBMT criteria when appropriate - To assess biological activity of AVE1642 in combination with Velcade on malignant plasma cells collected from bone marrow aspirates: saturation and down-regulation of the insulin-like growth factor 1 receptor (IGF-1R) and activity on the signalization pathway of the IGF-1 system (pAkt, pErk) when feasible - To detect immunogenicity reaction (HAHA) - To characterize PK and PD profile of a low dose (0.5 mg/kg) of AVE1642 expected to be non biologically active","other_id":"TED6420","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Multiple myeloma confirmed by bone marrow aspirate or biopsy\r\n\r\n          -  Patient had to have relapsed and/or refractory multiple myeloma after at least 1\r\n             standard therapy, and have demonstrated disease progression\r\n\r\n          -  Previous exposure to Velcade was allowed, provided no DLTs of Grade 3 or above had\r\n             been observed during previous treatment (for Part 2 of the study only)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior therapy with any IGF-1 system targeting compound\r\n\r\n          -  History of allogenic stem cell transplantation in case of concomitant\r\n             immunosuppressive therapy within 6 months before study entry. Patients having\r\n             undergone autologous stem cell transplantation(s) may have been included in the study\r\n\r\n          -  History of organ transplant and any patient receiving long term systemic\r\n             immunosuppressive therapy\r\n\r\n        The above information is not intended to contain all considerations relevant to a patient's\r\n        potential participation in a clinical trial.\r\n      ","sponsor":"Sanofi","sponsor_type":"Industry","conditions":"Multiple Myeloma","interventions":[{"intervention_type":"Drug","name":"Drug: AVE1642","description":"For Part 1, AVE1642 was administered on Day 1 and then every three weeks intra-venously with the dose escalation step starting at 3 mg/kg/infusion with a classical dose escalation schema of 3+3. For Part 2, AVE1642 was administered at doses ranging from 0.5 mg/kg to 12 mg/kg"},{"intervention_type":"Drug","name":"Drug: Velcade","description":"For Part 2 ONLY, fixed dose of 1.3 mg/m administered on Days 1, 4, 8, and 11."}],"outcomes":[{"outcome_type":"primary","measure":"definition of the Selected Dose (SD)","time_frame":"2 years","description":"Selected Dose will be based on the AVE1642 clearance /IGF-1 plateaus and on safety (less than 33% of pts with dose limiting toxicity (DLT)when administered as single agent in a first part of the study. The safety and pharmacokinetics of the regimen in combination with bortezomib will be assessed in the second part of the study"},{"outcome_type":"secondary","measure":"Assess the efficacy (complete, partial, minimal responses and stabilizations)","time_frame":"2 years","description":"According to the European Group for Blood and Marrow Transplantation (EBMT) criteria when appropriate (e.g. baseline M Protein, % Plasma Cells in Bone Marrow,skeletal disease status and at least one evaluable post-baseline assessment)"},{"outcome_type":"secondary","measure":"Pharmacokinetic drug interaction between AVE1642 and Velcade (part 2)","time_frame":"Day 22"}]}
{"nct_id":"NCT00822549","start_date":"2006-09-30","enrollment":438,"brief_title":"Pharmacokinetic, Pharmacodynamic and Pharmacogenetic of Morphine After Surgery","official_title":"Assessment of the Pharmacokinetic, Pharmacodynamic, Pharmacogenetic Relationships of Morphine and Metabolites After Severe Postoperative Pain in Adults","primary_completion_date":"2010-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2010-12-31","last_update":"2012-12-11","description":"The main objective of this study is to improve our knowledge on the pharmacodynamic, pharmacokinetic, and pharmacogenetic relationships of morphine administered to relief severe postoperative pain. The analysis will encompass the efficacy (acute during titration and subacute during the first 24 hours) and adverse effects of morphine. Our purpose is also to better characterize the age- and sex-related differences which probably markedly differ between the two periods (acute vs sub acute).","other_id":"AOR 05038","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients undergoing major orthopaedic surgery with severe postoperative pain. All the\r\n        patients included in the study received intravenous morphine","criteria":"\n        Inclusion criteria :\r\n\r\n          -  scheduled major orthopedic surgery\r\n\r\n          -  spine, hip or knee surgery\r\n\r\n          -  Body weight between 50 and 100 kg\r\n\r\n          -  Caucasians\r\n\r\n          -  ASA status 1 to 3\r\n\r\n          -  no cognitive dysfunction\r\n\r\n        Exclusion criteria :\r\n\r\n          -  allergy or contraindication to morphine\r\n\r\n          -  renal impairment (Cr Cl < 30 ml/min)\r\n\r\n          -  severe hepatic impairment\r\n\r\n          -  surgery performed under regional anaesthesia\r\n\r\n          -  preoperative treatment including strong or weak opioids\r\n\r\n          -  pregnancy, patients under 18 years, addiction\r\n      ","sponsor":"Assistance Publique - Hpitaux de Paris","sponsor_type":"Other","conditions":"Orthopaedic Surgery","interventions":[{"intervention_type":"Drug","name":"Drug: intravenous morphine titration","description":"intravenous morphine titration"}],"outcomes":[{"outcome_type":"primary","measure":"To improve our knowledge on the pharmacodynamic, pharmacokinetic and pharmacogenetic relationships of morphine administered after severe postoperative pain.","time_frame":"during the study"},{"outcome_type":"secondary","measure":"- Relationships between morphine consumption, clinical events (efficacy or adverse effects) and morphine (and metabolites) blood concentrations. Immediate postoperative period (PACU)","time_frame":"Immediate postoperative period (PACU)"},{"outcome_type":"secondary","measure":"- Relationships between clinical events (pain relief, failure in pain relief, adverse effects) and genetic polymorphism.","time_frame":"Immediate postoperative period (PACU)"},{"outcome_type":"secondary","measure":"- Relationships between sub-acute clinical events and PK/PG profile. (on the wards at 24 hours after surgery)","time_frame":"on the wards at 24 hours after surgery"},{"outcome_type":"secondary","measure":"To better characterize the age- and sex-related differences which differ between acute and sub-acute periods.","time_frame":"during the study"}]}
{"nct_id":"NCT00626067","start_date":"2006-09-30","phase":"Phase 4","enrollment":45,"brief_title":"Study of Patient Use and Perception of the Travatan Dosing Aid","official_title":"Pilot Study of Patient Acceptance and Impact of the New Travatan Compliance Monitoring Dispenser (Travatan Dosing Aid)","primary_completion_date":"2007-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-02-28","last_update":"2016-11-10","description":"The primary objective of this study is to determine the opinions of patients who are given the Travatan Compliance Monitoring Dispenser to use to dispense their Travatan glaucoma drops.","other_id":"IRB #06-762E","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Supportive Care","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Open angle glaucoma or ocular hypertension\r\n\r\n          -  Presently using Travatan eye drops\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Allergy to prostaglandin\r\n      ","sponsor":"Wills Eye","sponsor_type":"Other","conditions":"Glaucoma","interventions":[{"intervention_type":"Device","name":"Device: Fully functional monitoring device","description":"Pt received fully functional monitoring dispenser for use with their Travatan eye drops"},{"intervention_type":"Device","name":"Device: Partially functional monitoring device","description":"Patient received a particually functional Travatan Compliance Monitoring Dispenser"},{"intervention_type":"Device","name":"Device: Non-functional monitoring device","description":"Patient received a non functioning Travatan Compliance Monitoring Dispenser"}],"outcomes":[{"outcome_type":"primary","measure":"Assess patients' opinions regarding new Travatan Compliance Monitoring Dispenser","time_frame":"6 weeks"},{"outcome_type":"secondary","measure":"Pilot study of the impact of physician monitoring of compliance on patient compliance","time_frame":"6 weeks"}]}
{"nct_id":"NCT00452010","start_date":"2006-09-30","phase":"Phase 4","enrollment":236,"brief_title":"Pain Reducing Effect of Transcutaneous Electrical Nerve Stimulation in Patients With Chronic Low Back Pain or Lumbo-radiculalgia","official_title":"Pain Reducing Effect of Transcutaneous Electrical Nerve Stimulation (TENS) in Patients With Chronic Low Back Pain or Chronic Lumbo-radiculalgia and Followed in Pain Treatment Centers","primary_completion_date":"2008-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-09-30","last_update":"2012-07-04","description":"Prior studies showed contradictory results about the best type of TENS in chronic pain pathology. Therefore we want to evaluate the efficacy assessment of TENS on patients with chronic low back pain or chronic lumbo-radiculalgia. The functional ability score is evaluated by the Roland scale at 6 weeks.","other_id":"0601001","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Stable chronic low back pain or stable chronic lumbo-radiculalgia\r\n\r\n          -  Patients with a pain score at least superior or equal to 4\r\n\r\n          -  Patients followed in pain clinics\r\n\r\n          -  Written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior ambulatory TENS practice\r\n\r\n          -  Lumbo-radiculalgia pathology surgery within 3 months before inclusion\r\n\r\n          -  Acute low back pain or bilateral lumbo-radiculalgia\r\n\r\n          -  Acute radiculalgia\r\n\r\n          -  Surgery planned within 6 months\r\n\r\n          -  Pacemaker\r\n\r\n          -  Symptomatic low back pain\r\n      ","sponsor":"Centre Hospitalier Universitaire de Saint Etienne","sponsor_type":"Other","conditions":"Chronic Low Back Pain|Chronic Lumbo-radiculalgia","interventions":[{"intervention_type":"Device","name":"Device: CEFAR PRIMO TENS Class IIA (active)","description":"Active TENS. 4 sessions per day during 3 months."},{"intervention_type":"Device","name":"Device: CEFAR PRIMO TENS Class IIA (no active)","description":"Placebo TENS. 4 sessions per day during 3 months."}],"outcomes":[{"outcome_type":"primary","measure":"functional ability","time_frame":"Week 6"},{"outcome_type":"secondary","measure":"pain relief","time_frame":"Week 6 and Month 3"},{"outcome_type":"secondary","measure":"functional repercussions by Roland scale","time_frame":"Month 3"},{"outcome_type":"secondary","measure":"functional repercussions by Dallas scale","time_frame":"Month 3"},{"outcome_type":"secondary","measure":"quality of life","time_frame":"Day 1 and Month 3"},{"outcome_type":"secondary","measure":"global satisfaction of cares","time_frame":"Month 3"},{"outcome_type":"secondary","measure":"medical consumption","time_frame":"From Day 1 to Month 3"},{"outcome_type":"secondary","measure":"TENS observance","time_frame":"from Day 1 to Month 3"}]}
{"nct_id":"NCT00701038","start_date":"2006-08-31","phase":"N/A","enrollment":54,"brief_title":"Diagnosis and Treatment of Sleep Apnea in the Acute Exacerbation of Heart Failure","official_title":"The Role of Diagnosis and Treatment of Sleep Apnea in the Acute Exacerbation of Heart Failure","primary_completion_date":"2008-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-08-31","last_update":"2013-02-04","description":"Congestive heart failure affects 2.3 percent of the population (approximately 4,900,000) with an incidence of 10 per 1,000 of the population after the age of 65 (1). The admission rate for patients with heart failure is on the rise, so is the mortality associated with it and its national annual bill, now exceeding $21 billion (1). Obstructive Sleep Apnea (OSA) is present in 11-37 percent of patients with heart failure (2,3), and tends to increase in severity when the heart failure is less controlled (4, 5). Therefore, the actual prevalence of OSA in patients hospitalized with acute heart failure is likely higher. There is now evidence that treatment of OSA with nasal Continuous Positive Pressure (nCPAP) in outpatients with stable heart failure improves left ventricular ejection fraction, and quality of life (6), and confers a reduction in fatal and non-fatal cardiovascular events (7). However, there has not been any evaluation of the role of diagnosis and treatment of OSA in patients hospitalized with acute heart failure. This uncertainty about the true prevalence and role of OSA in exacerbations of heart failure, and the role of its treatment in the acute setting may explain why aggressive diagnostic and therapeutic strategy for OSA in patients admitted to the hospital with acute heart failure is not part of the standard clinical practice in acute care centers. Given the rising admission rate, and mortality associated with heart failure, an evaluation of the role of OSA and its treatment in this patient population is highly significant.","other_id":"2005H0186","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":21,"maximum_age":80,"population":"","criteria":"\n        .Inclusion Criteria:\r\n\r\n          -  Able to provide an informed consent\r\n\r\n          -  Speaks English\r\n\r\n          -  Older than 21\r\n\r\n          -  Heart Failure\r\n\r\n          -  Positive for OSA\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  CSA\r\n\r\n          -  Already on CPAP\r\n\r\n          -  Hemodynamic instability\r\n\r\n          -  Acute respiratory failure\r\n\r\n          -  Neurological defect\r\n\r\n          -  Dialysis\r\n      ","sponsor":"Rami Khayat","sponsor_type":"Other","conditions":"Sleep Apnea|Heart Failure","interventions":[{"intervention_type":"Device","name":"Device: auto adjusting bi-level positive airway pressure device","description":"auto adjusting bi-level positive airway pressure device is provided for treatment of obstructive sleep apnea."}],"outcomes":[{"outcome_type":"primary","measure":"Left Ventricular Ejection Fraction Improvement","time_frame":"baseline and again after three nights in hospital","description":"Left ventricular function was assessed using doppler ultrasound. Positive increase in left ventricular function from baseline to 3 nights post treatment indicates potential beneficial impact of treatment on heart function."}]}
{"nct_id":"NCT00282217","start_date":"2006-08-31","phase":"Phase 4","enrollment":100,"brief_title":"Study Evaluating Sirolimus in the Treatment of Kidney Transplant","official_title":"Sirolimus in the Treatment of Histological Defined Chronic Allograft Nephropathy","study_type":"Interventional","rec_status":"Completed","last_update":"2007-03-22","description":"The aim of this study is to test whether withdrawal of calcineurin inhibitors, followed by treatment with sirolimus, may improve renal function in renal transplant recipients with chronic allograft nephropathy.","other_id":"101467","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Renal transplantation\r\n\r\n          -  Biopsy-confirmed chronic rejection\r\n\r\n          -  Treatment with mofetil mycophenolate among cyclosporine or tacrolimus\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Transplant of any organ other than the kidney\r\n\r\n          -  Current important infection\r\n\r\n          -  Acute rejection within 12 weeks prior to inclusion\r\n      ","sponsor":"Wyeth is now a wholly owned subsidiary of Pfizer","sponsor_type":"Industry","conditions":"Kidney Failure|Kidney Diseases","interventions":[{"intervention_type":"Drug","name":"Drug: Sirolimus"}],"outcomes":[{"outcome_type":"primary","measure":"Renal function at 12 months; Comparison between slopes of glomerular filtration rate (GFR) of one year before versus one year after start on sirolimus"},{"outcome_type":"secondary","measure":"Histological parameters at 12 months"},{"outcome_type":"secondary","measure":"Cumulative incidence of biopsy-confirmed acute rejection at 12 months"},{"outcome_type":"secondary","measure":"Effect at 12 months on proteinuria, blood pressure, hyperlipidemia, and proteinuria"}]}
{"nct_id":"NCT00372944","start_date":"2006-08-31","phase":"Phase 2","enrollment":70,"brief_title":"AZD6244 vs. Capecitabine (Xeloda) in Patients With Advanced or Metastatic Pancreatic Cancer, Who Have Failed First Line Gemcitabine Therapy","official_title":"A Phase II, Open, Randomised Study to Assess the Efficacy and Safety of AZD6244 vs. Capecitabine (Xeloda) in Patients With Advanced or Metastatic Pancreatic Cancer, Who Have Failed First Line Gemcitabine Therapy","primary_completion_date":"2008-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-10-31","last_update":"2014-08-13","description":"The purpose of this study is to assess the efficacy and safety of AZD6244 (ARRY-142886)versus capecitabine in patients with advanced or metastatic pancreatic cancer who have failed first-line therapy with gemcitabine. Following baseline assessments, a minimum of 64 patients in approximately 5-6 centers from the US will be treated with either AZD6244 or capecitabine. Treatment will be continued for as long as the patients receive clinical benefit. The status of all patients will be checked (whether they are still taking treatment or not) approximately 3 months after the last patient has entered the study.","other_id":"D1532C00008","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Confirmed with pancreatic cancer\r\n\r\n          -  Have failed first line gemcitabine therapy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Previous therapy with EGFR inhibitor, MEK inhibitor or capecitabine.\r\n\r\n          -  Any recent surgery, unhealed surgical incision or severe condition such as\r\n             uncontrolled cardiac disease or chronic gastrointestinal diseases.\r\n      ","sponsor":"AstraZeneca","sponsor_type":"Industry","conditions":"Pancreatic Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: AZD6244","description":"oral capsule"},{"intervention_type":"Drug","name":"Drug: capecitabine","description":"oral tablet"}],"outcomes":[{"outcome_type":"primary","measure":"Median time to death (TTD)","time_frame":"Data cut off for this analysis was 5th April 2008.","description":"The TTD (days) was calculated as the interval from date of randomisation to date of patient death (from any cause). Patients who had not died at the time of the final analysis were censored at the last date the patient was known to be alive. Median TTD in days is presented here."},{"outcome_type":"secondary","measure":"Progression event count","time_frame":"The mandatory tumour assessment visit (MTAV) occurred on 27th February 2008 (+/-3days)","description":"The number of patients with a progression event occurring on or before MTAV where an event is defined as Objective and/or clinical disease progression as measured using RECIST criteria, or death from any cause"},{"outcome_type":"secondary","measure":"To assess the safety and tolerability of AZD6244 in the treatment of advanced or metastatic pancreatic cancer by review of adverse events (AEs) and laboratory parameters.","time_frame":"Review of AEs for duration of study, from First Subject in August 2006 to Last Subject Last visit October 2008"}]}
{"nct_id":"NCT00374530","start_date":"2006-08-31","phase":"N/A","enrollment":12,"brief_title":"Headache Inducing Characteristics and Possible Changes in Cerebral Blood Flow After Administration of PGE2","official_title":"Headache Inducing Characteristics and Possible Changes in Cerebral Blood Flow After Administration of PGE2","study_type":"Interventional","rec_status":"Completed","last_update":"2007-08-01","description":"Before, during and after intravenous administration of PGE2 we score/measure headache, rCBF, blood flow in the middle cerebral artery and diameter of superficial temporal artery and correlate that to known pathophysiology of headache to see if PGE2 is involved in headache pathophysiology.","other_id":"KA-20060026","allocation":"Randomized","intervention_model":"Crossover Assignment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy volunteers\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Primary Headache, headache on the day of the investigation, hypertension, hypotension,\r\n             pregnant/nursing, daily intake of medication (except oral contraceptives),\r\n             Cardiovascular or CNS disease, drug/alcohol abuse, psychiatric disease\r\n      ","sponsor":"Danish Headache Center","sponsor_type":"Other","conditions":"Headache|Migraine","interventions":[{"intervention_type":"Drug","name":"Drug: PGE2"}],"outcomes":[{"outcome_type":"primary","measure":"Headache"},{"outcome_type":"secondary","measure":"rCBF, blood flow, diameter of STA/RA, HR, BP"}]}
{"nct_id":"NCT00369915","start_date":"2006-08-31","phase":"Phase 2","enrollment":17,"brief_title":"The Antidepressant Efficacy of the Anticholinergic Scopolamine","official_title":"The Antidepressant Efficacy of the Anticholinergic Scopolamine","primary_completion_date":"2013-01-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2013-01-31","last_update":"2016-11-10","description":"A previous study showed that the intravenous administration of scopolamine produces antidepressant effects. This study is designed to determine if other routes of administration of scopolamine produce antidepressant effects.","other_id":"060234","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":55,"population":"","criteria":"\n        -  INCLUSION CRITERIA:\r\n\r\n        Two groups of subjects will be recruited for studies under this protocol: unipolar\r\n        depressives and bipolar depressives. Subjects with unipolar or bipolar depression appear to\r\n        exhibit abnormal cholinergic function during the depressed phase, and no differences are\r\n        hypothesized to exist between MDD and BD depressives herein. However, while BD subjects are\r\n        more difficult to recruit, the evidence for cholinergic abnormalities has been particularly\r\n        compelling for BD. Moreover, observations from our pilot study suggest that scopolamine\r\n        will improve symptoms in both MDD and BD, a particularly persuasive observation given BD\r\n        notoriously has been difficult to treat. Thus, the magnitude of this serious clinical\r\n        problem justifies the inclusion of BD subjects. Therefore both groups will be recruited.\r\n        However, BD Type I subjects will be included only if they are currently stable on lithium\r\n        or valproate to reduce the risks associated with possible precipitation of mania.\r\n\r\n        The presence of inclusion and exclusion criteria will be established using both an\r\n        unstructured clinical interview with a psychiatrist and the Structured Clinical Interview\r\n        for DSM-IV (SCID). Family history of mental illness will be obtained from the subject using\r\n        the Family Interview of Genetic Studies. We will recruit 24 subjects per group.\r\n\r\n        DEPRESSED SAMPLES: Subjects (ages 18-55) currently suffering from a major depressive\r\n        episode falling into one of the following subgroups:\r\n\r\n          1. . MAJOR DEPRESSIVE DISORDER (MDD): Subjects will be selected with primary MDD and are\r\n             currently depressed as defined by DSM-IV criteria for recurrent MDD and current MADRS\r\n             score in the moderately-to-severely depressed range (greater than or equal to 20). The\r\n             duration of the index episode is greater than or equal to four weeks.\r\n\r\n          2. . BIPOLAR DISORDER TYPE II (BD): Subjects will be selected who meet DSM-IV criteria\r\n             for bipolar disorder Type I or II and are currently depressed, with MADRS score in the\r\n             moderately-to-severely depressed range (greater than or equal to 20). The duration of\r\n             the index episode is greater than or equal to four weeks.\r\n\r\n        EXCLUSION CRITERIA:\r\n\r\n        Subjects will be recruited who are drug-naive or who have not received psychotropic drugs\r\n        for at least 3 weeks (8 weeks for fluoxetine) prior to screening. Subjects also will be\r\n        excluded if they have: a) serious suicidal ideation or behavior, or current delusions or\r\n        hallucinations, b) inability to provide informed consent, c) serious, unstable illnesses\r\n        including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including\r\n        ischemic heart disease, endocrinologic, neurologic, immunologic, or hematologic disease, d)\r\n        a history of drug or alcohol abuse within 6 months or alcohol or drug dependence in the\r\n        last five years (DSM IV criteria), e) not using a medically accepted means of contraception\r\n        and are a woman of childbearing potential, f) current pregnancy (documented by pregnancy\r\n        testing prior to each brain scan to avoid exposing a fetus to radiation or to a research\r\n        MRI scan that is not medically necessary), g) current breast feeding, h) history of\r\n        ulcerative colitis or toxic megacolon, i) vision and/or hearing problems severe enough to\r\n        interfere with testing, j) electrocardiographic evidence of ischemia, arrhythmia,\r\n        conduction defect, or myocardial infarction, k) current blood pressure of greater than 160\r\n        mm Hg or less than 90 mm Hg systolic, or greater than 90 mm Hg diastolic, l) clinically\r\n        significant cerebrovascular or cardiovascular disease, hypertension, congestive heart\r\n        disease, angina pectoris, clinic evidence of cerebrovascular disease, gross neurological\r\n        impairment, hyperthyroidism, known hypersensitivity or idiosyncracy to anticholinergic\r\n        agents (e.g. skin rashes), glaucoma, renal or hepatic impairment, m) current nicotine use\r\n        or nicotine dependence within last six months (due to the effects of nicotine on the\r\n        cholinergic system) n) narrow angle glaucoma (due to the possibility of exacerbation of\r\n        this condition by scopolamine) o) age greater than 55 years (to reduce the biological\r\n        heterogeneity encompassed by the MDD and BD criteria, since subjects with a late age-at\r\n        onset for depression have a far greater likelihood of having MRI correlates of\r\n        cerebrovascular disease than age-matched, healthy controls or age-matched, early-onset\r\n        depressives), p) exposure within two weeks to medications likely to affect mood or\r\n        cognition or likely to interact with scopolamine (e.g. narcotics or anti-cholinergic\r\n        agents)- as verified by history and urine drug screen, q) HIV positive status, r) history\r\n        of gastric or intestinal obstructions, s) history of urinary retention or bladder\r\n        obstruction. During the course of this study, participants will be unable to take some\r\n        medications, including antidepressant or antianxiety agents, sleep aids, diphenhydramine\r\n        (e.g. Benedryl) or cough/cold preparations that contain diphenhydramine or antihistamines.\r\n        A detailed list of allowed and not allowed medications is provided in Appendix B in the\r\n        protocol.\r\n\r\n        We are not excluding comorbid anxiety disorders. Exclusion of patients with comorbid\r\n        anxiety disorders would affect the generalizability of our findings since a substantial\r\n        percentage of patients with major depression have these comorbid diagnoses. Instead, we\r\n        will exclude patients with this comorbid diagnosis only if it is believed to be of clinical\r\n        significance. Allowing participation by patients with histories of comorbid anxiety\r\n        disorders broadens the inclusion criteria to more closely approximate patients seen in real\r\n        world settings.\r\n      ","sponsor":"National Institute of Mental Health (NIMH)","sponsor_type":"NIH","conditions":"Unipolar Depression|Bipolar Depression","interventions":[{"intervention_type":"Drug","name":"Drug: Scopolamine"},{"intervention_type":"Drug","name":"Drug: Scopolamine"}],"outcomes":[{"outcome_type":"primary","measure":"Change in Depression Severity","time_frame":"Outcome measures obtained at each of 12 sessions","description":"The Montgomery-Asberg Depression Rating Scale (MADRS) has a range of scores from 0 to 60 where the highest values indicate the most depression."},{"outcome_type":"secondary","measure":"Hamilton Anxiety Rating Scale","time_frame":"Each of 12 sessions.","description":"The Hamilton Anxiety Rating Scale (HARS) has a range of scores from 0 to 56 where the highest values indicate the most anxiety."}]}
{"nct_id":"NCT00425386","start_date":"2006-08-31","phase":"Phase 2","enrollment":60,"brief_title":"Sunitinib and Erlotinib in Treating Patients With Unresectable or Metastatic Kidney Cancer","official_title":"A Dose Escalation Phase II Study of Sunitinib Plus Erlotinib in Advanced Renal Carcinoma","primary_completion_date":"2010-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2014-03-31","last_update":"2017-05-03","description":"RATIONALE: Sunitinib and erlotinib may stop the growth of tumor cell by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib together with erlotinib may kill more tumor cells. PURPOSE: This phase II trial is studying the best dose of erlotinib when given together with sunitinib and to see how well they work in treating patients with unresectable or metastatic kidney cancer.","other_id":"CDR0000526204","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        DISEASE CHARACTERISTICS:\r\n\r\n          -  Histologically confirmed renal cell carcinoma with a component of clear cell or\r\n             papillary carcinoma\r\n\r\n               -  Unresectable or metastatic disease (radiologically or clinically confirmed)\r\n\r\n          -  Measurable disease ( 1 site)\r\n\r\n          -  No known brain metastasis that has not been adequately treated with radiotherapy\r\n             and/or surgery\r\n\r\n        PATIENT CHARACTERISTICS:\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2\r\n\r\n          -  Absolute neutrophil count  1,500/mm\r\n\r\n          -  Platelet count  100,000/mm\r\n\r\n          -  No grade 3 hemorrhage within the past 4 weeks\r\n\r\n          -  Bilirubin  1.5 times upper limit of normal (ULN)\r\n\r\n          -  Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT)  2.5 times ULN (<\r\n             5 times ULN if due to underlying disease)\r\n\r\n          -  No chronic liver disease (i.e., chronic active hepatitis or cirrhosis)\r\n\r\n          -  Creatinine  1.5 times ULN\r\n\r\n          -  None of the following cardiovascular conditions within the past 12 months:\r\n\r\n               -  Myocardial infarction\r\n\r\n               -  Severe/unstable angina\r\n\r\n               -  Coronary/peripheral artery bypass graft\r\n\r\n               -  Symptomatic congestive heart failure\r\n\r\n               -  Cerebrovascular accident or transient ischemic attack\r\n\r\n               -  Pulmonary embolism\r\n\r\n               -  Ongoing cardiac dysrhythmia  grade 2\r\n\r\n               -  Atrial fibrillation of any grade\r\n\r\n               -  Prolongation of the corrected QT (QTc) interval to > 450 msec for males or to >\r\n                  470 msec for females\r\n\r\n          -  Left Ventricular Ejection Fraction (LVEF) normal by Multigated Acquisition (MUGA) or\r\n             echocardiogram\r\n\r\n          -  No hypertension uncontrolled with medical therapy\r\n\r\n          -  No other active malignancy within the past 5 years except basal cell skin cancer or\r\n             cervical carcinoma in situ\r\n\r\n          -  No uncontrolled adrenal insufficiency\r\n\r\n          -  No uncontrolled hypothyroidism\r\n\r\n          -  Not pregnant or nursing\r\n\r\n          -  Negative pregnancy test\r\n\r\n          -  Fertile patients must use effective contraception during and for 3 months after\r\n             completion of study treatment\r\n\r\n          -  No severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic\r\n             renal disease, or active uncontrolled infection)\r\n\r\n          -  No impaired gastrointestinal (GI) function or GI disease that may significantly alter\r\n             the absorption of study drugs\r\n\r\n          -  No other severe acute or chronic medical or psychiatric condition or laboratory\r\n             abnormality that would preclude study participation\r\n\r\n        PRIOR CONCURRENT THERAPY:\r\n\r\n          -  See Disease Characteristics\r\n\r\n          -  More than 4 weeks since prior major surgery\r\n\r\n          -  More than 4 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas or\r\n             mitomycin C)\r\n\r\n          -  More than 4 weeks since prior radiotherapy\r\n\r\n          -  No prior radiotherapy to > 25% of the bone marrow\r\n\r\n          -  More than 28 days since prior investigational agents\r\n\r\n          -  No prior sunitinib malate\r\n\r\n          -  No prior anti-epidermal growth factor receptor therapy (e.g., erlotinib hydrochloride,\r\n             panitumumab, cetuximab, or gefitinib)\r\n\r\n          -  No concurrent therapeutic warfarin\r\n\r\n               -  Low-dose oral warfarin  2 mg daily for deep vein thrombosis prophylaxis is\r\n                  allowed after the maximum tolerated dose of erlotinib hydrochloride is determined\r\n\r\n          -  No concurrent Hypericum perforatum (St. John's wort)\r\n\r\n          -  No concurrent chemotherapy or biologic therapy\r\n\r\n          -  No other concurrent anticancer therapy\r\n\r\n          -  No other concurrent investigational agents\r\n      ","sponsor":"OHSU Knight Cancer Institute","sponsor_type":"Other","conditions":"Kidney Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: erlotinib hydrochloride","description":"Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;\r\n100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;\r\n150 mg/day, continuous daily"},{"intervention_type":"Drug","name":"Drug: sunitinib malate","description":"Will be administered at 50 mg daily, 4 weeks on, 2 weeks off"},{"intervention_type":"Procedure","name":"Procedure: biopsy","description":"Paraffin block (or unstained slides) of the primary tumor and/or metastatic lesions (as available) and a plasma sample for future correlative studies will be collected. A paraffin block (or at least 10 unstained slides, each of 10 micromillimeter thickness) from the original paraffin-embedded biopsy material taken at the diagnosis will be stored at 4 degrees Celsius."}],"outcomes":[{"outcome_type":"primary","measure":"Maximum Tolerated Dose (MTD) of Erlotinib Hydrochloride When Used in Combination With Sunitinib.","time_frame":"Participants assessed for DLTs weekly during the first cycle of treatment and every 3 weeks in subsequent cycles until at least one DLT occurs in 33% or more of participants at that dose; participants assessed for the duration of the study, up to 7 years","description":"The MTD is defined as the dose that produces dose limiting toxicity (DLT) in 33% of the patients."},{"outcome_type":"primary","measure":"Progression-free Survival at 8 Months","time_frame":"8 months after initiating treatment with sunitinib in combination with erlotinib in patients with metastatic or unresectable clear cell or papillary carcinoma of the kidney","description":"Defined as the proportion of patients who are progression free (CR, PR and SD) at 8 months after initiating treatment with sunitinib in combination with erlotinib in patients with metastatic or unresectable clear cell or papillary carcinoma of the kidney. Complete Response (CR)= disappearance of all target lesions, Partial Response (PR)= At least a 30% decrease in the sum of the longest diameter of target lesions, and Stable Disease (SD)= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (20% increase in the sum)."},{"outcome_type":"secondary","measure":"To Determine the Safety of Sunitinib in Combination With Erlotinib","time_frame":"For the duration of the study, up to 7 years"},{"outcome_type":"secondary","measure":"Median Time to Progression","time_frame":"For the duration of the study, up to 7 years","description":"The Kaplan-Meier method will be used to estimate the median time to progression."},{"outcome_type":"secondary","measure":"Proportion of Patients Whose Best Overall Response is Complete Response, Partial Response, Stable Disease, or Progressive Disease","time_frame":"From the start of treatment until the criteria for response is met."},{"outcome_type":"secondary","measure":"Maximum Percent Change in Tumor Measurement","time_frame":"Baseline through end of study, up to 7 years","description":"The maximum percent change in Tumor Measurement is the greatest percent change in longest diameter (LD) for the target lesions from the baseline LD. For patients with no change in LD, the maximum percent change is the lowest increase in LD from the baseline LD."}]}
{"nct_id":"NCT00398983","start_date":"2006-08-31","phase":"Phase 2/Phase 3","enrollment":50,"brief_title":"Randomized Study of Decitabine in Maintenance Therapy of Acute Myeloid Leukemia (AML)","official_title":"Randomized Study of Decitabine Versus Observation or Continued Standard Chemotherapy as Maintenance Therapy for Adults With Unfavorable Risk AML in First Complete Remission (CR) or Adults With Relapsed AML in Second or Greater CR","primary_completion_date":"2012-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-05-31","last_update":"2013-03-04","description":"The goal of this clinical study is to find out whether continued therapy with decitabine after achieving a remission in acute myeloid leukemia (AML) patients can help prolong the remission and prevent relapse of the disease.","other_id":"2006-0358","allocation":"Randomized","intervention_model":"Factorial Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adult patients (greater than 18 years) with acute myelogenous leukemia (AML) by World\r\n             Health Organization (WHO) criteria (greater than 20% blasts) and unfavorable risk\r\n             cytogenetics (including intermediate and poor risk categories) in first CR or complete\r\n             remission without full platelet recovery (CRp)\r\n\r\n          -  Adult patients (greater than 18 years) in second or subsequent Complete Response (CR)\r\n             (or CRp)\r\n\r\n          -  Patients in first CR (or CRp) may have received any induction chemotherapy regimen;\r\n             they may have received post-remission consolidation therapy (except for transplant)\r\n             prior to inclusion in this protocol\r\n\r\n          -  Patients in 2nd or subsequent CR (or CRp) may have received any appropriate salvage\r\n             regimen before achieving CR and may have received further therapy before inclusion\r\n\r\n          -  Performance status of 0, 1, or 2\r\n\r\n          -  Adequate organ function with creatinine less than or equal to 2.0 mg/dL, bilirubin\r\n             less than or equal to 3.5 mg/dL and aspartate aminotransferase (AST or SGOT) and\r\n             alanine aminotransferase (ALT or SGPT) less than or equal to 3 times institutional\r\n             upper limit of normal\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnant or lactating; women of child-bearing potential (WOCBP) must have negative\r\n             pregnancy test. WOCBP defined as not post-menopausal for 12 months or no previous\r\n             surgical sterilization\r\n\r\n          -  Known to be HIV+\r\n\r\n          -  Active and uncontrolled disease/infection as judged by the treating physician\r\n\r\n          -  Unable or unwilling to sign the consent form\r\n\r\n          -  No other investigational therapy within the past 14 days\r\n      ","sponsor":"M.D. Anderson Cancer Center","sponsor_type":"Other","conditions":"Acute Myelogenous Leukemia","interventions":[{"intervention_type":"Drug","name":"Drug: Decitabine","description":"20 mg/m^2 IV over 1 hour daily for 5 days"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants With Relapse-Free Response at 1 Year","time_frame":"Baseline to 1 year","description":"Relapse free response defined an absence of relapse at one year of follow up."}]}
{"nct_id":"NCT00394940","start_date":"2006-07-31","enrollment":2085,"brief_title":"Identifying Inflammatory Biomarkers of Chronic Obstructive Pulmonary Disease","official_title":"Serum Inflammatory Biomarkers as Predictors of COPD Morbidity and Mortality","primary_completion_date":"2013-01-31","study_type":"Observational","rec_status":"Completed","completion_date":"2013-01-31","last_update":"2017-12-06","description":"Chronic obstructive pulmonary disease (COPD) is a condition that is characterized by airway obstruction due to inflammation. Levels of inflammatory proteins may be linked to when and to what extent COPD develops. This study will use data collected during the Tucson Epidemiological Study of Airway Obstructive Disease (TESAOD) and its 33-year follow-up to determine the relationship between inflammatory protein expression and COPD.","other_id":"1349","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","population":"Sample of the general population that was enrolled in 1972","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Enrolled in the Tucson Epidemiological Study of Airway Obstructive Disease (TESAOD)\r\n      ","sponsor":"University of Arizona","sponsor_type":"Other","conditions":"Chronic Obstructive Pulmonary Disease","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"COPD development defined as FEV1/FVC < 70%","time_frame":"up to 50 years"},{"outcome_type":"secondary","measure":"COPD progression defined based on decline of lung function","time_frame":"up to 50 years"},{"outcome_type":"secondary","measure":"Mortality","time_frame":"up to 50 years"}]}
{"nct_id":"NCT00954577","start_date":"2006-07-31","enrollment":1000,"brief_title":"Reduce Obesity and Diabetes","official_title":"The Pathogenesis of Type 2 Diabetes in Children and Utility of a School-based Intervention to Reduce Obesity and Diabetes in Children","primary_completion_date":"2012-05-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2012-06-30","last_update":"2009-08-07","description":"This study examines risk factors for type 2 diabetes in children representing multiple discrete ethnic groups. It also examines the short term effects of school-based health education supervised exercise on metabolic risk factors for type 2 diabetes mellitus in children. The investigators hypothesize that exercise and health education will significantly improve insulin sensitivity in all children, especially in children who are already insulin resistant, thereby lowering the risk that they will go on to develop type 2 diabetes mellitus. The specific hypotheses being tested are: 1. Insulin resistance will be most evident in overweight children while an impaired ability of the pancreas to release insulin will be most evident in children with a family history of type 2 diabetes mellitus. 2. Exercise will significantly improve insulin resistance (as measured by the fasting glucose/insulin ratio) with little effect on insulin secretory capacity in children. 3. Participation in a school-based health, nutrition, and exercise education program will have long term beneficial effects on health related behaviors and on insulin resistance in all children, regardless of their level of diabetes risk.","other_id":"amdecroad","observational_model":"Case-Crossover","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":10,"maximum_age":15,"population":"Children in 6th-8th grade.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Children in 6th-8th grade\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Diabetes\r\n\r\n          -  Exercise induced asthma\r\n\r\n          -  Pregnancy\r\n\r\n          -  Any chronic medication that interferes with glucose homeostasis\r\n      ","sponsor":"Academy for Medical Development and Collaboration, New York","sponsor_type":"Other","conditions":"Type 2 Diabetes|Pediatric Obesity|Dyslipidemia","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Nutrition, health, and exercise education","description":"The classroom intervention is part of the routine science curriculum and consists of 14 sessions taught by the investigators. Topics covered include the development of type 2 diabetes, nutrition education, exercise education, and overall healthy lifestyle education (both at home and in school). The intervention is offered in each year to all grades and to all students, regardless of whether or not they are enrolled in the study. The exercise intervention is optional and consists of 2-3 sessions per week of aerobic exercise (dancing) taught by pediatric trainers and offered in lieu of regular gym classes."}],"outcomes":[{"outcome_type":"primary","measure":"Reduction in diabetes risk factors including insulin secretory capacity, insulin sensitivity, body fat content, dyslipidemia, and circulating concentrations of pro-inflammatory cytokines.","time_frame":"In December and May of each school year"},{"outcome_type":"secondary","measure":"Improvement in self-esteem and in health-related behaviors.","time_frame":"December and May of each school year"}]}
{"nct_id":"NCT00372203","start_date":"2006-07-31","phase":"Phase 2","enrollment":200,"brief_title":"Endobronchial Ultrasound vs Mediastinoscopy in NSCLC","official_title":"Prospective Controlled Trial of Mediastinoscopy Compared With Endobronchial Ultrasound Guided Transbronchial Needle Aspiration for Assessment of the Mediastinum in Lung Cancer.","primary_completion_date":"2010-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-03-31","last_update":"2017-05-04","description":"Proper staging of Lung cancer is of paramount concern when determining a treatment regime. Currently the assessment of surgical candidacy is performed with the staging process, mainly the mediastinoscopy. A mediastinoscopy has the ability to access samples of the paratracheal lymph node stations (Levels 2R, 2L, 3, 4R, 4L), as well as the anterior subcarinal lymph node station (Level 7). In comparison, the EBUS-TBNA technique is a real-time procedure that has the potential to access the same paratracheal and subcarinal lymph node stations associated with the mediastinoscopy, but also extending out to the hilar lymph nodes (Levels 10 and 11). Because of the possibility of extended sampling range and a reduction in procedural invasiveness, EBUS-TBNA may represent a more efficient patient centered alternative to mediastinoscopy in the staging of lung cancer patients. Additionally, patients who are have lymph nodes in the N2 region frequently undergo chemotherapy and/or radiotherapy prior to surgery. Assessment of the lymph nodes after chemo/radiation is done using CT scans, as re-mediastinoscopy is a technically difficult procedure. These patients may benefit from EBUS-TBNA.","other_id":"06-0085-A","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        A) Age 18 years or older B) Patients with confirmed or suspected non-small cell lung cancer\r\n        who require a mediastinoscopy as part of their staging investigations of the mediastinum to\r\n        determine suitability for lung cancer resection will be considered for the trial.\r\n\r\n        C) Patients with undiagnosed enlarged lymph nodes in the mediastinum suspicious for lung\r\n        cancer in which a tissue diagnosis is required.\r\n\r\n        Exclusion Criteria:\r\n\r\n        A) Patients who are deemed on clinical grounds not to be medically fit for a bronchoscopy\r\n        or a mediastinoscopy or who are not suitable for definitive surgical resection by\r\n        thoracotomy will be excluded.\r\n\r\n        B) Patients who have verified stage IV disease or who are not appropriate for lung cancer\r\n        resection by virtue of direct invasion of mediastinal structures or large parts of the\r\n        chest wall.\r\n\r\n        C) Known small cell lung cancer. D) Patients where there is a high clinical suspicion of\r\n        lymphoma. E) Inability to give informed consent.\r\n      ","sponsor":"University Health Network, Toronto","sponsor_type":"Other","conditions":"Non-small Cell Lung Cancer","interventions":[{"intervention_type":"Procedure","name":"Procedure: Endobronchial Ultrasound Guided Transthoracic Needle Biopsy","description":"Endobronchial Ultrasound Guided Transthoracic Needle Biopsy of mediastinal lymph nodes at the time of the mediastinoscopy."}],"outcomes":[{"outcome_type":"primary","measure":"Sensitivity","time_frame":"1 day"}]}
{"nct_id":"NCT00310583","start_date":"2006-07-31","phase":"Phase 4","enrollment":120,"brief_title":"Effects of Pregabalin on Mechanical Hyperalgesia","official_title":"Effects of Pregabalin on Mechanical Hyperalgesia - EPOM","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2008-04-30","last_update":"2007-04-05","description":"The aim of this randomized placebo-controlled study is to evaluate the effects of analgetics for neuropathic pain on mechanical hyperalgesia as a kind of evoked pain. Therefore the number of responders and non-responders on pregabalin will be evaluated in respect of mechanical hyperalgesia (stimulus-response-function (SRF) on static punctual stimuli evoking pain determined via pinprick). The hypothesis is that in the placebo group the amount of non-responders is increased.","other_id":"2005-000411-10","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Recruitment:\r\n\r\n          -  Age above 18 years;\r\n\r\n          -  Neuropathic pain of at least 4/10 for at least 6 months;\r\n\r\n          -  Mechanical hyperalgesia;\r\n\r\n          -  One of the following diagnoses: peripheral nerve lesion, plexus lesion, radicular\r\n             lesion, spinal lesion, polyneuropathy, postzosteric neuralgia;\r\n\r\n          -  No nerve block or other interventional treatment for at least 4 weeks;\r\n\r\n          -  Constant medication for at least 4 weeks;\r\n\r\n          -  Signed informed consent;\r\n\r\n          -  WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L\r\n             or equivalent units of HCG) within 72 hours prior to the start of study medication;\r\n\r\n          -  Women of childbearing potential (WOCBP) must be using an adequate method of\r\n             contraception to avoid pregnancy throughout the study and for up to 4 weeks after the\r\n             study in such a manner that the risk of pregnancy is minimized.\r\n\r\n        Enrolment open titration:\r\n\r\n          -  All principal inclusion criteria at recruitment\r\n\r\n          -  Relevant mechanical hyperalgesia: SRF affected/control at least 2.0 with a minimal SRF\r\n             of 0.8.\r\n\r\n        Enrolment double-blind phase:\r\n\r\n          -  At least 30% reduction in mechanical hyperalgesia (SRF) in the open titration;\r\n\r\n          -  WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L\r\n             or equivalent units of HCG) within 72 hours prior to the start of study medication;\r\n\r\n          -  Women of childbearing potential (WOCBP) must be using an adequate method of\r\n             contraception to avoid pregnancy throughout the study and for up to 4 weeks after the\r\n             study (see above recruitment).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Anaphylaxis on the active component or any other component of Lyrica or the placebo\r\n             (Lyrica: pregabalin, lactose-monohydrate, corn starch, talcum; capsule shells:\r\n             gelatine, titanium dioxide (E 171), natriumdodecylsulfat, high dispersive\r\n             siliciumdioxide, purified water; ink: shellac, black iron(II,III)-oxide (E 172),\r\n             propyleneglycol, kaliumhydroxide; additionally in placebo: microcrystalline cellulose,\r\n             sucrose octaacetate, magnesium stearate)\r\n\r\n          -  Intake of gabapentin or pregabalin within the last 4 weeks prior to recruitment\r\n\r\n          -  Any surgery within the last two months or any scheduled surgery within the study\r\n             period (20 weeks);\r\n\r\n          -  Concurrent unstable disease involving any system, e.g. advanced carcinoma, acute\r\n             myocardial infarction, renal failure, or any other condition that in the opinion of\r\n             the Investigator would deem the patient unsuitable for the study;\r\n\r\n          -  History of cerebral vascular or other cerebral disease;\r\n\r\n          -  Concurrent chronic or acute pain of other origin (osteoarthritis), which is not\r\n             treated effectively\r\n\r\n          -  Concurrent severe mental deficit, e.g. psychiatric disorders as defined by DSM IV\r\n             including schizophrenia, mood disorders, organic brain syndrome, psychotic/delusional\r\n             disorders, serious psychosis;\r\n\r\n          -  Concurrent serious neurological disease, e.g. dementia, multiple sclerosis, or any\r\n             other disease that would have impact on the ability of the patient to give their\r\n             consent for the participation in the study or influences the pain perception;\r\n\r\n          -  Concurrent atrioventricular block second degree or higher\r\n\r\n          -  Concurrent renal failure (CLcr < 30 ml/min)\r\n\r\n          -  Concurrent hereditary galactose-intolerance\r\n\r\n          -  Concurrent lapp-lactase insufficiency\r\n\r\n          -  Concurrent glucose-galactose-malabsorption\r\n\r\n          -  Concurrent sub-optimal stabilized Diabetes Mellitus (Hb1Ac > 12%)\r\n\r\n          -  Clinical apparent overdosage of opioids or psychopharmaca\r\n\r\n          -  Recent history (6 months) or current evidence of alcohol or drug abuse;\r\n\r\n          -  Participation in any other investigational drug or therapy study within the previous\r\n             90 days;\r\n\r\n          -  Women who are pregnant or breastfeeding;\r\n\r\n          -  Women with a positive pregnancy test on enrollment or prior to study drug\r\n             administration;\r\n\r\n          -  Women of childbearing potential who are unwilling or unable to use an acceptable\r\n             method to avoid pregnancy for the entire study period and for up to 4 weeks after the\r\n             study. Women practicing abstinence should use a reliable method of contraception\r\n             (except birth control pills) if they choose to become sexually active during the\r\n             study.\r\n      ","sponsor":"Professional Associations Clinic Bergmannsheil","sponsor_type":"Other","conditions":"Tactile Hyperalgesia|Neuropathic Pain","interventions":[{"intervention_type":"Drug","name":"Drug: Pregabalin"}],"outcomes":[{"outcome_type":"primary","measure":"number of responders and non-responders in respect of mechanical hyperalgesia (stimulus-response-function (SRF) on static punctual stimuli evoking pain determined via pinprick)"},{"outcome_type":"secondary","measure":"Degree of mechanical hyperalgesia"},{"outcome_type":"secondary","measure":"Ongoing pain (numerical rating scale)"},{"outcome_type":"secondary","measure":"Neuropathic Pain Symptom Inventory score"},{"outcome_type":"secondary","measure":"Additional QST (qualitative sensory testing) variable CDT = cold detection threshold,"},{"outcome_type":"secondary","measure":"Additional QST (qualitative sensory testing) variable HDT = heat detection threshold"},{"outcome_type":"secondary","measure":"Additional QST (qualitative sensory testing) variable TSL = thermal sensory limen"},{"outcome_type":"secondary","measure":"Additional QST (qualitative sensory testing) variable PHS = number of paradoxical heat sensations during the TSL Procedure"},{"outcome_type":"secondary","measure":"Additional QST (qualitative sensory testing) variable CPT = cold pain threshold"},{"outcome_type":"secondary","measure":"Additional QST (qualitative sensory testing) variable HPT = heat pain threshold"},{"outcome_type":"secondary","measure":"Additional QST (qualitative sensory testing) variable MDT = mechanical detection threshold"},{"outcome_type":"secondary","measure":"Additional QST (qualitative sensory testing) variable MPT = mechanical pain threshold"},{"outcome_type":"secondary","measure":"Additional QST (qualitative sensory testing) variable ALL = dynamic mechanical allodynia"},{"outcome_type":"secondary","measure":"Additional QST (qualitative sensory testing) variable WUR = windup ratio"},{"outcome_type":"secondary","measure":"Additional QST (qualitative sensory testing) variable VDT = vibration detection threshold"},{"outcome_type":"secondary","measure":"Additional QST (qualitative sensory testing) variable PPT = pressure pain threshold)"}]}
{"nct_id":"NCT00353002","start_date":"2006-07-31","phase":"N/A","enrollment":0,"brief_title":"A Comparison of Amethocaine Cream vs. Liposomal Lidocaine Cream for Venipuncture in Children.","official_title":"A Comparison of Amethocaine Creams Versus Liposomal Lidocaine Cream as Pain Reliever Prior to Venipuncture in Children at the Paediatric Emergency Department.","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2006-12-31","last_update":"2017-08-28","description":"All patients undergoing venepuncture or venous cannulation in pediatric emergency department will be treated with either Amethocaine, or Liposomal Lidocaine (4%) cream at the site of cannulation in order to determine the efficacy of these creams in controlling pain during procedures and to determine the success rate of these procedures.","other_id":"R-06-266","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":5,"maximum_age":12,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  All children age who are visiting the paediatric emergency department and need for IV\r\n             cannulation or blood workup as part of their management. The need for IV placement or\r\n             blood drawing will be based on the clinical evaluation of the child by experienced\r\n             triage nursing personnel.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Lack of parental agreement\r\n\r\n          -  Broken skin\r\n\r\n          -  Known sensitivity to Amethocaine or Liposomal Lidocaine cream.\r\n\r\n          -  Children with critical illness requiring immediate cannulation (e.g., sepsis, severe\r\n             dehydration, Trauma)\r\n\r\n          -  Children who are already receiving opioid analgesia or topical anesthesia.\r\n\r\n          -  Children who have already participated in the study.\r\n      ","sponsor":"Lawson Health Research Institute","sponsor_type":"Other","conditions":"Pain","interventions":[{"intervention_type":"Drug","name":"Drug: Ametop (4% Amethocaine cream )"},{"intervention_type":"Drug","name":"Drug: Maxilene (4% Liposomal Lidocaine)"}],"outcomes":[{"outcome_type":"primary","measure":"Facial pain scale score of child during procedure","time_frame":"Immediate"},{"outcome_type":"secondary","measure":"Compare local and systemic side effects of both creams","time_frame":"Within hour of procedure"}]}
{"nct_id":"NCT00362882","start_date":"2006-07-31","phase":"Phase 2","enrollment":81,"brief_title":"Docetaxel and Bortezomib in Treating Patients With Progressive or Recurrent Non-Small Cell Lung Cancer","official_title":"Randomized Phase II Trial of Sequential Versus Concurrent Docetaxel and PS-341 (NSC 681239) in Previously Treated Non-Small Cell Lung Cancer (NSCLC)","primary_completion_date":"2010-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-07-31","last_update":"2017-12-05","description":"This trial is studying two different schedules of docetaxel and bortezomib to compare how well they work in treating patients with progressive or recurrent non-small cell lung cancer. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving docetaxel together with bortezomib may kill more tumor cells","other_id":"NCI-2009-00123","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":120,"population":"","criteria":"\n        Criteria:\r\n\r\n          -  No other prior malignancy except adequately treated basal cell or squamous cell skin\r\n             cancer, in situ cervical cancer, adequately treated stage I or II cancer for which the\r\n             patient is currently in complete remission, or any other cancer for which the patient\r\n             has been disease-free for 5 years.\r\n\r\n          -  Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).\r\n\r\n          -  Progressive or recurrent NSCLC after treatment with 1 prior platinum-based\r\n             chemotherapy regimen for metastatic disease. Prior neoadjuvant/adjuvant chemotherapy\r\n             and/or concurrent chemoradiation for early-stage disease allowed.\r\n\r\n          -  At least 4 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas)\r\n             and recovered.\r\n\r\n          -  No prior docetaxel or bortezomib\r\n\r\n          -  Prior epidermal growth factor receptor inhibitor therapy allowed.\r\n\r\n          -  Prior paclitaxel allowed\r\n\r\n          -  At least 4 weeks since prior major surgery and recovered.\r\n\r\n          -  At least 2 weeks since prior and no concurrent enzyme-inducing anticonvulsants.\r\n\r\n          -  No concurrent hormonal therapy, biologic therapy, or radiotherapy to measurable\r\n             lesions. Concurrent palliative radiotherapy to small-field nonindicator lesions (e.g.,\r\n             painful bony metastases) allowed.\r\n\r\n          -  Measurable disease* with >= 1 unidimensionally objectively measurable lesion,\r\n             including any of the following:\r\n\r\n          -  Lung mass (measurable on chest x-ray, tomograms, or CT scan)\r\n\r\n          -  Enlarged lymph nodes\r\n\r\n          -  Liver metastasis (measurable as a discrete focal lesion on radionuclide or CT scan, or\r\n             ultrasound)\r\n\r\n          -  Metastatic abdominal mass (measurable on CT scan with >= 1 perpendicular diameter \r\n             the distance between cuts)\r\n\r\n          -  Measurable disease must be outside the previous radiation field or a new lesion must\r\n             be present.\r\n\r\n          -  Life expectancy >= 12 weeks\r\n\r\n          -  Progressive disease within a previously radiated field allowed.\r\n\r\n          -  [Note: *Measurable disease DOES NOT include bone metastases or non-focal liver\r\n             metastases].\r\n\r\n          -  No symptomatic or untreated brain metastasis requiring steroids. Asymptomatic,\r\n             previously treated (surgical resection or radiotherapy) brain metastasis allowed\r\n             provided they are neurologically stable and >= 4 weeks since prior steroids.\r\n\r\n          -  Creatinine clearance >= 50 mL/min\r\n\r\n          -  Creatinine =< 1.6 mg/dL\r\n\r\n          -  Bilirubin normal\r\n\r\n          -  AST =< 2 times upper limit of normal\r\n\r\n          -  Not pregnant or nursing\r\n\r\n          -  Negative pregnancy test\r\n\r\n          -  Fertile patients must use effective contraception\r\n\r\n          -  No peripheral neuropathy >= grade 2\r\n\r\n          -  Absolute granulocyte count >= 1,500/mm\r\n\r\n          -  Platelet count >= 100,000/mm\r\n\r\n          -  Cutaneous nodule\r\n\r\n          -  ECOG performance status 0-1\r\n\r\n          -  At least 4 weeks since prior radiotherapy and recovered.\r\n      ","sponsor":"National Cancer Institute (NCI)","sponsor_type":"NIH","conditions":"Non-small Cell Lung Cancer|Recurrent Non-small Cell Lung Cancer|Stage IV Non-small Cell Lung Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: docetaxel","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: bortezomib","description":"Given IV"},{"intervention_type":"Other","name":"Other: laboratory biomarker analysis","description":"correlative study"},{"intervention_type":"Other","name":"Other: immunoenzyme technique","description":"correlative study"},{"intervention_type":"Other","name":"Other: immunohistochemistry staining method","description":"correlative study"},{"intervention_type":"Other","name":"Other: pharmacological study","description":"correlative study"}],"outcomes":[{"outcome_type":"secondary","measure":"Progression-free Survival @ 6 Months","time_frame":"6 months","description":"Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."},{"outcome_type":"primary","measure":"Overall Response Rate","time_frame":"Up to 4 years","description":"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR"},{"outcome_type":"secondary","measure":"Overall Survival","time_frame":"From first day of treatment to time of death due to any cause, up to 4 years","description":"Will be estimated using the product-limit method of Kaplan and Meier."},{"outcome_type":"secondary","measure":"Disease Control Rate","time_frame":"Up to 4 years","description":"Disease control rate was defined as the rate of partial response (PR) plus stable disease (SD; for at least 2 cycles)."}]}
{"nct_id":"NCT00366379","start_date":"2006-07-31","phase":"Phase 2","enrollment":127,"brief_title":"A Dose-Titration Study of GK Activator (2) in Patients With Type 2 Diabetes.","official_title":"An Open Label Study to Determine the Effect on Fasting Glucose Levels, and Safety, of Increasing Doses of GK Activator (2) in Patients With Type 2 Diabetes Not Optimally Controlled With One Previous Oral Antihyperglycemic Agent.","primary_completion_date":"2007-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-06-30","last_update":"2016-11-02","description":"This study will assess the efficacy, safety and tolerability of increasing doses of GK Activator (2) in patients with type 2 diabetes whose condition has not been optimally controlled with one previous oral antihyperglycemic agent. After a 2 week washout from their previous antidiabetic therapy, patients will receive GK Activator (2) orally, twice a day for 12 weeks, at increasing doses of 25mg bid to 200mg bid; doses will be titrated to achieve a target fasting glucose level (FPG) of <100mg/dL. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.","other_id":"BC19800","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  adult patients, 18-75 years of age;\r\n\r\n          -  type 2 diabetes mellitus treated with one oral antihyperglycemic agent for >=3 months\r\n             prior to screening.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  type 1 diabetes mellitus;\r\n\r\n          -  treatment with insulin, PPAR agonists or systemic corticosteroids during the 3 months\r\n             prior to screening;\r\n\r\n          -  women who are pregnant, breast-feeding or not using adequate contraceptive methods.\r\n      ","sponsor":"Hoffmann-La Roche","sponsor_type":"Industry","conditions":"Diabetes Mellitus Type 2","interventions":[{"intervention_type":"Drug","name":"Drug: GK Activator (2)","description":"25-200mg po bid for 20 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of patients at each dose who achieve FPG <100mg/dL.","time_frame":"Throughout study"},{"outcome_type":"secondary","measure":"Mean change in HbA1c and FPG from baseline to endpoint; absolute/relative changes in lipid profile.","time_frame":"At intervals throughout study"},{"outcome_type":"secondary","measure":"AEs, laboratory parameters.","time_frame":"Throughout study"}]}
{"nct_id":"NCT00717171","start_date":"2006-07-31","phase":"Phase 4","enrollment":100,"brief_title":"Efficacy of the SurgiStim3 Electrical Stimulation Device in Persons Undergoing Anterior Cruciate Ligament Repair","official_title":"Efficacy of the SurgiStim3 Electrical Stimulation Device in Persons Undergoing Anterior Cruciate Ligament Repair","primary_completion_date":"2009-06-30","study_type":"Interventional","rec_status":"Terminated","completion_date":"2009-06-30","last_update":"2009-01-12","description":"The purpose of this study is to determine whether a functional electrical stimulation device, the SurgiStim3, decreases pain, pain medications and/or edema in patients undergoing anterior cruciate ligament repair.","other_id":"S060501-ACL","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":64,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Agree to provide informed consent to be included within this ACL study\r\n\r\n          -  Demonstrate a continued willingness to be compliant with the parameters established\r\n             under the study;\r\n\r\n          -  Have no history of drug or alcohol abuse in the last 2 years;\r\n\r\n          -  Be either a male or female adult between the ages of 18 and 64;\r\n\r\n          -  Be undergoing a surgical repair of the anterior cruciate ligament (ACL) using either a\r\n             hamstring, patella tendon, Achilles tendon, or allograft procedure; and\r\n\r\n          -  Understand that there is no financial remuneration for participation in the study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnant women\r\n\r\n          -  Insulin dependent diabetic patients\r\n\r\n          -  Patients with a demand type pacemaker\r\n\r\n          -  Patients who have a malignant tumor (other than basal cell epithelioma)\r\n\r\n          -  Patients with a known history of alcohol or drug abuse in the last 2 years\r\n\r\n          -  Patients who will not agree to provide informed consent to be included within this ACL\r\n             study\r\n\r\n          -  Patients who demonstrate a continued unwillingness to be compliant with the parameters\r\n             established under this study.\r\n\r\n          -  \"Poor healers\" as identified by the patient's medical history\r\n\r\n          -  Patients who have a history of sensitivity to surgical tape, electrode adhesives, etc.\r\n\r\n          -  Patients with a known history of RSD (reflex sympathetic dystrophy)\r\n\r\n          -  Patients with a history of chronic pain (on opiates or high dosage of NSAIDS for 3\r\n             months or greater)\r\n\r\n          -  Patients who have previously undergone an ACL reconstruction on the same knee\r\n\r\n          -  Patients with clinically varicose veins (clinically significant or symptomatic)\r\n\r\n          -  Patients whose history shows an abuse of diuretics or anti-inflammatory medications\r\n\r\n          -  Patients who will undergo multiple ligament surgery (i.e., ACL plus PCL, MCL, and/or\r\n             LCL)\r\n      ","sponsor":"VQ OrthoCare","sponsor_type":"Industry","conditions":"Anterior Cruciate Ligament","interventions":[{"intervention_type":"Device","name":"Device: SurgiStim3","description":"Electrical stimulation device that provides interferential, high voltage pulsed current and neuromuscular waveforms in sequence. The device runs continuously for the first 2 days following surgery, then runs 3 times a day for 1 hour on days 3 through 42."},{"intervention_type":"Device","name":"Device: SurgiStim3","description":"The placebo device is programmed to run for the same amount of time, at the same schedule, using the same waveforms as the functional device over the course of the 42 days. The placebo device, however, will only increase to 80% of the patient-set amplitude after a one minute set-up period and will only turn on for 6 seconds of every minute (3s ramp up, 1s on time, 2s ramp down)."}],"outcomes":[{"outcome_type":"primary","measure":"pain","time_frame":"post-op days 1, 3, 5, 7, 14, 21, 28, 35, 42"},{"outcome_type":"secondary","measure":"pain medications","time_frame":"post-op days 1, 3, 5, 7, 14, 21, 28, 35, 42"},{"outcome_type":"secondary","measure":"edema","time_frame":"post-op days 7, 14, 21, 28, 35, 42"}]}
{"nct_id":"NCT00352794","start_date":"2006-07-07","phase":"Phase 2","enrollment":40,"brief_title":"Lenalidomide for Patients With Myelofibrosis (MF)","official_title":"Evaluation of Lenalidomide (CC-5013) and Prednisone as a Therapy for Patients With Myelofibrosis (MF)","primary_completion_date":"2018-03-08","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-03-08","last_update":"2019-07-23","description":"The goal of this clinical research study is to learn if lenalidomide in combination with prednisone can help to control myelofibrosis. The safety of lenalidomide and prednisone for the treatment of myelofibrosis will also be studied.","other_id":"2005-0206","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Diagnosis of myelofibrosis requiring therapy, including those previously treated and\r\n             relapsed or refractory, or if newly diagnosed, with intermediate or high risk\r\n             according to Lille scoring system (risk factors are: Hb < 10 g/dl, White blood count\r\n             (WBC) < 4 or > 30 x 109/L; risk group: 0 factor(s) = low, 1 factor(s) = intermediate,\r\n             2 factor(s) = high) or with symptomatic splenomegaly\r\n\r\n          2. Understanding and voluntary signing an Institutional Review Board (IRB)-approved\r\n             informed consent form.\r\n\r\n          3. Age >/= 18 years at the time of signing the informed consent.\r\n\r\n          4. Disease-free of prior malignancies for >/= 2-years with exception of basal cell or\r\n             squamous cell carcinoma of the skin, or carcinoma \"in situ\" of the cervix or breast.\r\n\r\n          5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.\r\n\r\n          6. Patients must have adequate organ function as demonstrated by the following: Total\r\n             bilirubin <\/= 2.0 mg/dL (unless higher due to MF); Serum creatinine <\/= 2.0 mg/dL\r\n             (unless higher due to MF); Absolute neutrophil count >/= 1 x 10^9/L; Alanine\r\n             transaminase (ALT) <\/= 3 x upper limit of normal (unless higher due to MF).\r\n\r\n          7. Females of childbearing potential (FCBP) must have a negative serum or urine\r\n             pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to\r\n             and again within 24 hours of starting lenalidomide and must either commit to continued\r\n             abstinence from heterosexual intercourse or begin TWO acceptable methods of birth\r\n             control, one highly effective method and one additional effective method AT THE SAME\r\n             TIME, at least 4 weeks before she starts taking lenalidomide. FCBP must also agree to\r\n             ongoing pregnancy testing.\r\n\r\n          8. Continuation of 7. Men must agree to use a condom during sexual contact with a female\r\n             of child bearing potential even if they have had a successful vasectomy. All patients\r\n             must be counseled at a minimum of every 28 days about pregnancy precautions and risks\r\n             of fetal exposure. See Appendix J: Risks of Fetal Exposure, Pregnancy Testing\r\n             Guidelines and Acceptable Birth Control Methods\r\n\r\n          9. footnote to no 7.  A female of childbearing potential is a sexually mature woman who:\r\n             1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been\r\n             naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at\r\n             any time in the preceding 24 consecutive months).\r\n\r\n         10. All study participants must be registered into the mandatory RevAssist program, and\r\n             be willing and able to comply with the requirements of RevAssist.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Use of any other standard (e.g. hydroxyurea, anagrelide, growth factors) or\r\n             experimental drug or therapy within 28 days of starting lenalidomide and/or lack of\r\n             recovery from all toxicity from previous therapy to grade 1 or better.\r\n\r\n          2. Known prior clinically relevant hypersensitivity reaction to thalidomide, including\r\n             the development of erythema nodosum if characterized by a desquamating rash.\r\n\r\n          3. Prior therapy with lenalidomide.\r\n\r\n          4. Any serious medical condition, laboratory abnormality, or psychiatric illness that\r\n             would prevent the subject from signing the informed consent form.\r\n\r\n          5. Suspected Pregnancy. Pregnant or lactating females.\r\n\r\n          6. Any condition, including the presence of laboratory abnormalities, which places the\r\n             subject at unacceptable risk if he/she were to participate in the study or confounds\r\n             the ability to interpret data from the study.\r\n\r\n          7. Known positive for HIV or infectious hepatitis, type A, B or C.\r\n\r\n          8. Known prior clinically relevant hypersensitivity to prednisone.\r\n\r\n          9. Participants with a heart rate (HR) of less than or equal to 50, as a HR less than 50\r\n             indicates underlying cardiac abnormalities.\r\n\r\n         10. Participants with prior history of thromboembolic disease (i.e.-deep venous thrombosis\r\n             (DVT) or pulmonary embolism (PE)) within the last six months, as Lenalidomide has\r\n             demonstrated a significantly increased risk of DVT or PE.\r\n      ","sponsor":"M.D. Anderson Cancer Center","sponsor_type":"Other","conditions":"Myelofibrosis","interventions":[{"intervention_type":"Drug","name":"Drug: Lenalidomide","description":"Oral 10 mg daily/days 1-21 of 28 day cycle"},{"intervention_type":"Drug","name":"Drug: Prednisone","description":"Starting dose oral 30 mg/day during cycle 1, 15 mg/day during cycle 2, and 15 mg every other day during cycle 3, and then it will be discontinued."}],"outcomes":[{"outcome_type":"primary","measure":"Number of Patients With Objective Response (Complete and Partial Response + Hematological Improvement)","time_frame":"6 months","description":"Time to response defined as the time from start of therapy until the response criteria are fulfilled. Response duration defined as the time from response until relapse (progressive disease) or death."}]}
{"nct_id":"NCT00333034","start_date":"2006-06-30","phase":"Phase 3","enrollment":120,"brief_title":"Study Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly in Subjects With Psoriasis","official_title":"A Multicenter, Parallel, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly in Subjects With Moderate to Severe Plaque Psoriasis","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-05-31","last_update":"2007-12-06","description":"The primary objective is to assess the efficacy and safety of etanercept 50 mg administered once weekly in subjects with psoriasis over 12 weeks.","other_id":"0881A6-318","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria: -Adults greater than or equal to 18 years of age with clinically stable\r\n        plaque psoriasis involving greater than or equal to 10% of the body surface and a minimum\r\n        Psoriasis Area and Severity Index (PASI) score of 10 at screening. -Failure to respond to,\r\n        or have a contraindication to, or intolerant to at least 1 of the following systemic or\r\n        phototherapies at an adequate dose of sufficient duration: Methotrexate (MTX), Acitretin,\r\n        Cyclosporine, Ultraviolet A (UVA), Ultraviolet B (UVB), Psoralen and Ultraviolet A (PUVA),\r\n        Fumarate Exclusion Criteria: -Previous treatment with etanercept, antibody to TNF or other\r\n        TNF inhibitors. -Active guttate, erythrodermic, or pustular psoriasis at the time of the\r\n        screening or baseline.&#xd;\r\n      ","sponsor":"Wyeth is now a wholly owned subsidiary of Pfizer","sponsor_type":"Industry","conditions":"Psoriasis","interventions":[{"intervention_type":"Drug","name":"Drug: Etanercept"}],"outcomes":[{"outcome_type":"primary","measure":"The primary efficacy endpoint is the PASI 75 response at week 12. PASI 75 is defined as a 75% or greater improvement in PASI score from baseline."},{"outcome_type":"secondary","measure":"The secondary efficacy endpoints will include but not limited to: PASI 50, PASI 75 (at visit other than week 12, PASI 90, PASI score PGA of 0 or 1 (clear or minimal, Patient global assessment of psoriasis, DLQI,"},{"outcome_type":"secondary","measure":"EQ5D, FACIT-F."}]}
{"nct_id":"NCT00354445","start_date":"2006-06-30","phase":"Phase 4","enrollment":1000,"brief_title":"A Clinical Trial to Explore the Safety and Efficacy of Injections of Macugen When Given Every 6 Weeks in Subjects With AMD","official_title":"A Phase IV, Open Label, Multi-Center, Study of Maintenance Intravitreous Injections of Macugen (Pegaptanib Sodium) Given Every 6 Weeks for 48 Weeks in Subjects With Subfoveal Neovascular Age-Related Macular Degeneration (AMD) Initially Treated With a Modality Resulting in Maculopathy Improvement","study_type":"Interventional","rec_status":"Unknown status","last_update":"2007-01-15","description":"The purpose of this study is to explore the safety and efficacy of Macugen given as maintenance therapy in patients who have had initial success with another AMD treatment. Patients must have 1, but not more than 3 prior treatments for Neovascular AMD.","other_id":"EOP1023","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subfoveal CNV secondary to AMD\r\n\r\n          -  At least 1 but not more than 3 prior treatments for AMD\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subfoveal scar or subfoveal atrophy\r\n\r\n          -  Significant media opacities, including cataract, which might interfere with visual\r\n             acuity\r\n      ","sponsor":"Eyetech Pharmaceuticals","sponsor_type":"Industry","conditions":"Age-Related Macular Degeneration (AMD)","interventions":[{"intervention_type":"Drug","name":"Drug: pegaptanib sodium (Macugen)"}],"outcomes":{}}
{"nct_id":"NCT00332241","start_date":"2006-06-30","phase":"Phase 3","enrollment":98,"brief_title":"Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)","official_title":"A Multicenter Double-Blind, Randomized, Placebo-Controlled, Flexible-Dosed, Parallel-Group Study of Aripiprazole Flexibly Dosed in the Treatment of Children and Adolescents With Autistic Disorder (AD)","primary_completion_date":"2008-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-04-30","last_update":"2013-12-02","description":"This study will compare the effectiveness (how well the drug works) of aripiprazole, flexibly dosed with a placebo, in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).","other_id":"CN138-178","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":6,"maximum_age":17,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Meets current Diagnostic and Statistical Manual for Mental Disorders-Fourth Edition\r\n             (DSM-IV) diagnostic criteria for AD and demonstrates serious behavioral problems.\r\n             Diagnosis confirmed by Autism Diagnostic Interview- Revised (ADI-R)\r\n\r\n          -  CGI score > = 4 AND and Aberrant Behavior Checklist (ABC) Irritability/Agitation\r\n             subscale score > = 18 at screening and baseline (randomization)\r\n\r\n          -  Mental age of at least 18 months\r\n\r\n          -  Male or female 6 to 17 years of age, inclusive, at the time of randomization\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients considered treatment resistant to neuroleptic medication based on lack of\r\n             therapeutic response to 2 different neuroleptics after treatment of at least 3 weeks\r\n             each.\r\n\r\n          -  Patients previously treated and not responding to aripiprazole treatment\r\n\r\n          -  The patient is currently diagnosed with another disorder on the autism spectrum,\r\n             including PDD-NOS, Asperger's Disorder, Rett's Disorder, Fragile-X Syndrome or\r\n             Childhood Disintegrative Disorder\r\n\r\n          -  Current diagnosis of bipolar disorder, psychosis, or schizophrenia, or major\r\n             depression\r\n\r\n          -  A seizure in the past year\r\n\r\n          -  History of severe head trauma or stroke\r\n\r\n          -  Patients undergoing non-pharmacologic therapies (e.g., psychotherapy, behavioral\r\n             modification) must have started at least 2 months prior to the initial screening visit\r\n             and must remain in a consistent treatment program for the duration of the study.\r\n      ","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","sponsor_type":"Industry","conditions":"Autistic Disorder","interventions":[{"intervention_type":"Drug","name":"Drug: Aripiprazole","description":"Tablets, Oral, 5, 10, or 15 mg, once daily, 8 weeks"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Tablets, Oral, once daily, 8 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score","time_frame":"Week 8","description":"The ABC is a 58-item informant-based assessment of problem behaviors in children/adolescents with mental retardation. Items are rated on a 4-point scale (0=no problem, 3=severe problem), and resolve into 5 domain subscales. A decrease in score indicates improvement."},{"outcome_type":"secondary","measure":"Mean Clinical Global Impressions Improvement Scale (CGI-I) Score","time_frame":"Week 8","description":"The CGI scale is a clinician-rated global assessment of a patient's improvement over time. Baseline assessment rated a patient's condition on a 7-point scale (1=no symptoms, 7=very severe symptoms). Subsequent assessed improvement relative to baseline symptoms on a 7-point CGI-I item scale (1=very much improved, 7=very much worse)."},{"outcome_type":"secondary","measure":"Number of Participants With Response at Week 8","time_frame":"Week 8","description":"Response defined as a ≥ 25% reduction from baseline to endpoint in the ABC Irritability Subscale score and a CGI-I score of 1 or 2 at endpoint"},{"outcome_type":"secondary","measure":"Mean Change (Week 8 - Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only)","time_frame":"Week 8","description":"CY-BOCS=10-item assessment of obsessive-compulsive symptoms in patients <18 years. 5 items pertaining to compulsions rate symptoms (time spent, interference with functioning, distress, resistance, control) on a 5-point scale (0=no symptoms/minimum severity, 4=extreme symptoms/maximum severity). A decrease in value indicates improvement."},{"outcome_type":"secondary","measure":"Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores","time_frame":"Week 8","description":"Mean change (Week 8 - baseline) in the other ABC subscale scores (lethargy/social withdrawal; stereotypic behavior; hyperactivity/ noncompliance; inappropriate speech). A decrease in value indicates improvement"},{"outcome_type":"secondary","measure":"Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S)","time_frame":"Week 8","description":"A CGI-S assessment (a 7-point scale to evaluate the severity of symptoms) was performed at baseline (1=no symptoms; 7=very severe symptoms). The patient's improvement relative to the symptoms at baseline on were assessed on a 7-point CGI-I (1=very much improved; 7=very much worse). A decrease in value indicates improvement."},{"outcome_type":"secondary","measure":"Summary of Safety","time_frame":"continuous throughout the study","description":"Deaths, Adverse Events (AEs), Serious AEs (SAEs), Treatment-Emergent AEs and AEs leading to discontinuation"},{"outcome_type":"secondary","measure":"Change From Baseline in Body Weight","time_frame":"Week 8","description":"Adjusted mean change (Week 8 - baseline) in body weight"}]}
{"nct_id":"NCT00689715","start_date":"2006-06-30","phase":"Phase 2/Phase 3","enrollment":50,"brief_title":"Long Term Outcomes After EUS-guided Ablation for Cystic Tumors of the Pancreas","official_title":"Long Term Outcomes After EUS-guided Ablation for Cystic Tumors of the Pancreas","primary_completion_date":"2016-08-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2016-08-31","last_update":"2016-07-26","description":"Cystic lesions of the pancreas are defined as round, fluid-filled structures within the pancreas detected by radiologic imaging. With widespread use of cross-sectional imaging modalities for various indications, such lesions are now detected in nearly 20% of abdominal imagings, with the majority discovered incidentally. These lesions encompass a wide spectrum of histopathologic entities and biologic behavior, ranging from benign to malignant. Substantial morphologic overlap restricts the accuracy in diagnosing specific type of cystic lesion in spite of recent advances in diagnostic modalities. It is a challenging issue to differentiate each cystic lesion and make a management plan since cystic lesions that are relatively common and asymptomatic may possess malignant potential. Although inflammatory pseudocysts were thought to account for 80-90% of cystic lesions of the pancreas, with cystic tumors accounting for the remaining,10 the latter may occur much more frequently than traditionally estimated. To date, surgical resection is generally recommended for malignant and potentially malignant lesions. However, surgical resection of the pancreas still carries substantial morbidity and sometimes mortality, especially for the cystic lesion located in the head portion. Therefore, management should be individualized by risk-benefit analysis for each patient. Recently, a pilot study of EUS-guided ethanol lavage for cystic tumors of the pancreas reported that complete resolution was achieved in only one-third of patients even though epithelial lining ablation was demonstrated in all resected specimens. Therefore, more effective treatment modalities or ablation agents are required to improve treatment responses. Intratumoral or intraperitoneal injection of chemotherapeutic agent has been used for endobronchial lesions of lung cancer, brain tumors and advanced ovarian cancer.13-16 EUS-guided injection of antitumor material has been reported in advanced pancreatic cancer. Although local injection of chemotherapeutic agents into pancreatic cystic tumors has not yet been reported, it is reasonable to suggest that such an approach may have an additive effect on ablation of the epithelial lining of cystic tumor when combined with ethanol lavage. Paclitaxel, a widely used chemotherapeutic agent, inhibits cell processes that are dependent on microtubule turnover. Due to its highly hydrophobic nature,19 paclitaxel is expected to exert its effect longer when instilled within a closed cavity such as a cyst. The hydrophobic and viscous nature of paclitaxel may reduce the possibility of it leaking through a puncture site and causing complications. The present study evaluated safety, feasibility and response following EUS-guided ethanol lavage with paclitaxel injection (EUS-EP) for treating cystic tumors of the pancreas.","other_id":"AMC0183","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  uni- or oligo-locular cystic tumors\r\n\r\n          -  indeterminate cystic tumors for which EUS-guided fine needle aspiration (FNA) was\r\n             required to obtain additional information\r\n\r\n          -  cystic tumors that increased in size during the observation period\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  cystic tumors which had the typical morphology of serous cystadenomas (i.e., honeycomb\r\n             appearance) and pseudocysts (i.e., parenchymal changes)\r\n\r\n          -  evidence of communication between the cystic lesion and the main pancreatic duct\r\n             according to endoscopic retrograde pancreatograms\r\n\r\n          -  overt carcinomas with peripancreatic invasion\r\n\r\n          -  patients with a bleeding tendency (prothrombin time > 1.5 international normalized\r\n             ratio [INR] or platelet count < 50,000/L).\r\n      ","sponsor":"Asan Medical Center","sponsor_type":"Other","conditions":"Cystic Tumors of the Pancreas","interventions":[{"intervention_type":"Procedure","name":"Procedure: Endoscopic ultrasonography-guided ethanol lavage with paclitaxel injection","description":"A curvilinear-array echoendoscope and a 22 gauge needle were then used for cyst fluid aspiration, ethanol lavage and paclitaxel injection. The maximum possible volume of cyst fluid was aspirated, and the needle tip was carefully maintained inside the cyst to avoid parenchymal injury. Ethanol was injected into the collapsed cyst until the original shape was restored, and a lavage was then performed for 3-5 minutes. Pure ethanol (99%) was used for all patients except the first 2 in whom 88% ethanol was used. After reaspiration of the injected ethanol, the cyst cavity was injected with a solution containing 3 mg/mL paclitaxel and the needle then carefully retracted. The high viscosity of paclitaxel necessitated dilution in 0.9% normal saline for administration via a 22G needle. The volume of the paclitaxel solution administered was the same as the volume of the cyst fluid aspirated."}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of adverse events Treatment response by change of calculated cyst volume","time_frame":"early (< 7 days) and late (> 7days) adverse events"},{"outcome_type":"primary","measure":"recurrence during follow up","time_frame":"any recurrence of cyst after complete resolution during at least 3 years follow up"},{"outcome_type":"secondary","measure":"treatment response","time_frame":"1 year"},{"outcome_type":"secondary","measure":"predictive factors for complete resolution","time_frame":"1 year"}]}
{"nct_id":"NCT02038712","start_date":"2006-06-30","phase":"N/A","enrollment":93,"brief_title":"fMRI and Ghlrein in Obesity and Binge Eating Disorder","official_title":"fMRI and Ghlrein in Obesity and Binge Eating Disorder","primary_completion_date":"2008-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-09-30","last_update":"2014-01-16","description":"Binge Eating Disorder (BED) may be associated with he development of obesity. However, the pathogenesis of BED is currently unclear, thus making the development of treatment and prevention strategies for BED difficult. Differences in the mechanisms regulating food intake may go some way to reveal potential mechanisms for BED.The purpose of this study is to investigate the responses of key gut-derived hormones that are associated with the regulation of food intake and functional brain activity to food cues using fMRI in BED patients and weight matched controls.","other_id":"06-164","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age 18-65 years\r\n\r\n          -  BMI 30-50 kg/m2\r\n\r\n          -  Weight stable (<5% change in body weight during past 3 months)\r\n\r\n          -  Right handed\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Smokers\r\n\r\n          -  Regular use of medications\r\n\r\n          -  Current or intended participation in a weight-loss program (diet or exercise)\r\n\r\n          -  Females who are pregnant or lactating\r\n      ","sponsor":"New York Obesity and Nutrition Research Center","sponsor_type":"Other","conditions":"Obesity|Binge Eating Disorder","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Fed Condition","description":"Subjects will consume a 600mL 600kcal liquid test meal"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Fasted condition","description":"Subjects will consume 600mL plain water."},{"intervention_type":"Procedure","name":"Procedure: Blood samples","description":"Blood samples will be collected at -15, 0, 10, 30, 60, 90, 120 min"},{"intervention_type":"Behavioral","name":"Behavioral: Subjective appetite ratings","description":"Appetite ratings will be collected at -15, 0, 10, 30, 60, 90, 120 min."},{"intervention_type":"Procedure","name":"Procedure: fMRI scan","description":"Blood Oxygen Dependent (BOLD) signal response to pictures and words of food and non-food items will be measured using functional magnetic resonance imaging (fMRI)."}],"outcomes":[{"outcome_type":"primary","measure":"fMRI responses to food cues","time_frame":"45 min","description":"Blood oxygen dependent signal (BOLD) response in exposure to auditory and visual food cues will be measured during a fMRI scan and the difference between responses in the fed condition compared with those in the fasted condition."},{"outcome_type":"secondary","measure":"Gut hormone responses","time_frame":"120 min","description":"Blood samples will be collected at -15, 0, 10, 30, 60, 90, 120 min following the ingestion of the liquid test meal and analyzed to determine the gut hormone responses."},{"outcome_type":"secondary","measure":"Subjective appetite ratings","time_frame":"120 min","description":"Subjective ratings of appetite will be collected using a visual analogue scale (VAS) at -15, 0, 10, 30, 60, 90, 120 min following the liquid test meal"}]}
{"nct_id":"NCT00827099","start_date":"2006-06-30","phase":"Phase 2","enrollment":5,"brief_title":"Umbilical Cord Blood (UCB) Transplant, Fludarabine, Melphalan, and Anti-thymocyte Globulin (ATG) in Treating Patients With Hematologic Cancer","official_title":"Transplantation of Two Partially Matched Umbilical Cord Blood Units Following Reduced Intensity Conditioning to Enhance Engraftment and Limit Transplant-Related Mortality in Adults With Hematologic Malignancies","primary_completion_date":"2009-11-30","study_type":"Interventional","rec_status":"Terminated","completion_date":"2009-11-30","last_update":"2012-03-23","description":"RATIONALE: Giving low doses of chemotherapy before a donor umbilical cord blood transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and mycophenolate mofetil after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving umbilical cord blood transplant together with fludarabine, melphalan, and antithymocyte globulin works in treating patients with hematologic cancer.","other_id":"CDR0000632453","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        DISEASE CHARACTERISTICS:\r\n\r\n          -  Diagnosis of hematologic malignancy for which a reduced-intensity allogeneic stem cell\r\n             transplantation is deemed clinically appropriate, including any of the following:\r\n\r\n               -  Chronic myelogenous leukemia, meeting one of the following criteria:\r\n\r\n                    -  In first chronic phase AND failed imatinib mesylate therapy, defined as\r\n                       failure to obtain a hematologic remission by 3 months or major cytogenetic\r\n                       response (Ph+ cells < 35%) by 12 months, or demonstrated clonal evolution or\r\n                       disease progression while on therapy\r\n\r\n                    -  In accelerated phase with < 15% blasts\r\n\r\n                    -  In blast crisis that has entered into a second chronic phase following\r\n                       induction chemotherapy\r\n\r\n               -  Acute myelogenous leukemia, meeting one of the following criteria:\r\n\r\n                    -  In second or subsequent completion remission*\r\n\r\n                    -  Failed primary induction chemotherapy, but subsequently entered into a\r\n                       complete remission* with  2 subsequent re-induction chemotherapy\r\n                       treatment(s)\r\n\r\n                    -  In first complete remission* with poor-risk cytogenetics NOTE: *Complete\r\n                       remission is defined as < 5% blasts in bone marrow, no definitive evidence\r\n                       of disease by morphology, flow cytometry, or genetic studies, and no\r\n                       circulating blasts. Neutrophil and platelet count recovery will not be\r\n                       required.\r\n\r\n               -  Acute lymphoblastic leukemia, meeting one of the following criteria:\r\n\r\n                    -  In second or subsequent complete remission\r\n\r\n                    -  In first complete remission AND t(9;22)\r\n\r\n               -  Myelodysplastic syndromes, meeting the following criteria:\r\n\r\n                    -  High-risk disease, defined as International Prognostic Scoring System score\r\n                       of  1.5\r\n\r\n                    -  Less than 10% blasts at the time of study enrollment\r\n\r\n               -  Chronic myelomonocytic leukemia\r\n\r\n                    -  Less than 10% blasts at the time of study enrollment\r\n\r\n               -  Myeloid metaplasia with myelofibrosis with poor-risk features, meeting one of the\r\n                  following criteria:\r\n\r\n                    -  Age < 55 years AND a Lille score of 1\r\n\r\n                    -  Lille score of 2\r\n\r\n                    -  Hemoglobin < 10 g/dL AND abnormal karyotype\r\n\r\n               -  Chronic lymphocytic leukemia/prolymphocytic leukemia, meeting all of the\r\n                  following criteria:\r\n\r\n                    -  Rai stage I-IV disease\r\n\r\n                    -  Failed  1 prior chemotherapy regimen, including fludarabine, or autologous\r\n                       stem cell transplantation\r\n\r\n                    -  Chemosensitive or stable, non-bulky disease prior to transplant\r\n\r\n                    -  Received  3 prior chemotherapy regimens (monoclonal antibody therapy and\r\n                       involved-field radiotherapy are not considered prior regimens)\r\n\r\n               -  Low-grade B-cell non-Hodgkin lymphoma (NHL) (small lymphocytic lymphoma,\r\n                  follicular center [grade 1 or 2] lymphoma, or marginal zone lymphoma), meeting\r\n                  all of the following criteria:\r\n\r\n                    -  Failed  1 prior chemotherapy regimen or autologous stem cell\r\n                       transplantation\r\n\r\n                    -  Chemosensitive or stable, non-bulky disease prior to transplant\r\n\r\n                    -  Received  3 prior chemotherapy regimens (monoclonal antibody therapy and\r\n                       involved-field radiotherapy are not considered prior regimens)\r\n\r\n               -  Intermediate-grade B-cell or T-cell NHL or mantle cell NHL, meeting all of the\r\n                  following criteria:\r\n\r\n                    -  Failed to achieve remission or recurred after either conventional\r\n                       chemotherapy or autologous stem cell transplantation\r\n\r\n                    -  Chemosensitive, non-bulky disease prior to transplant\r\n\r\n               -  Hodgkin lymphoma, meeting all of the following criteria:\r\n\r\n                    -  Relapsed after prior autologous stem cell transplantation or after  2\r\n                       combination chemotherapy regimens AND ineligible for autologous peripheral\r\n                       blood stem cell transplantation\r\n\r\n                    -  Chemosensitive, non-bulky disease prior to transplant\r\n\r\n               -  Multiple myeloma, meeting one of the following criteria:\r\n\r\n                    -  Relapsed after autologous stem cell transplantation\r\n\r\n                    -  Relapsed after conventional therapies AND not a candidate for autologous\r\n                       stem cell transplantation\r\n\r\n          -  No HLA-matched related or unrelated donor available\r\n\r\n          -  Has two umbilical cord blood units available that are matched at  4/6 HLA A, B, and\r\n             DRB1 with the patient and with each other (HLA C and DQ will not be used in the match\r\n             strategy)\r\n\r\n               -  Total combined nucleated cell dose from the 2 umbilical cord blood units must be\r\n                  > 3.7 x 10^7 nucleated cells/kg (pre-freeze dose) NOTE: A new classification\r\n                  scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology\r\n                  of \"indolent\" or \"aggressive\" lymphoma will replace the former terminology of\r\n                  \"low\", \"intermediate\", or \"high\" grade lymphoma. However, this protocol uses the\r\n                  former terminology.\r\n\r\n        PATIENT CHARACTERISTICS:\r\n\r\n          -  Karnofsky performance status 80-100%\r\n\r\n          -  Adapted, weighted Charlson Comorbidity Index < 3\r\n\r\n          -  Serum creatinine  2.0 mg/dL\r\n\r\n          -  AST or ALT < 3 times upper limit of normal (ULN)\r\n\r\n          -  Bilirubin < 1.5 times ULN\r\n\r\n          -  Not pregnant or nursing\r\n\r\n          -  LVEF  40%\r\n\r\n          -  DLCO > 50%\r\n\r\n          -  No hypoxia at rest with oxygen saturation < 92% on room air (corrected with\r\n             bronchodilator therapy)\r\n\r\n          -  No active opportunistic infection (e.g., fungal pneumonia, tuberculosis, or viral\r\n             infection)\r\n\r\n          -  No active hepatitis B or C infection that, in the opinion of a gastroenterologist or\r\n             the transplant committee, places the patient at moderate- to high-risk for developing\r\n             severe hepatic disease\r\n\r\n          -  No HIV infection\r\n\r\n        PRIOR CONCURRENT THERAPY:\r\n\r\n          -  See Disease Characteristics\r\n      ","sponsor":"Northside Hospital, Inc.","sponsor_type":"Other","conditions":"Myeloproliferative Disorders|Leukemia|Lymphoma|Multiple Myeloma and Plasma Cell Neoplasm|Myelodysplastic Syndromes","interventions":[{"intervention_type":"Biological","name":"Biological: anti-thymocyte globulin","description":"anti-thymocyte globulin"},{"intervention_type":"Drug","name":"Drug: fludarabine phosphate","description":"fludarabine phosphate"},{"intervention_type":"Drug","name":"Drug: Melphalan","description":"melphalan"},{"intervention_type":"Drug","name":"Drug: mycophenolate mofetil","description":"mycophenolate mofetil"},{"intervention_type":"Drug","name":"Drug: tacrolimus","description":"tacrolimus"},{"intervention_type":"Procedure","name":"Procedure: umbilical cord blood transplantation","description":"umbilical cord blood transplantation"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants With 100 Day Transplant-related Mortality (TRM)","time_frame":"100 days","description":"100 Day TRM is death within 100 days from transplant related complications"},{"outcome_type":"secondary","measure":"Number of Patients That Engrafted Blood Counts by 30 Days After Transplant","time_frame":"Day 30","description":"Number of patients whose Absolute Neutrophil Count (ANC) recovered to >500 x10^3/uL for at least 3 consecutive days after transplant"},{"outcome_type":"secondary","measure":"Percentage of Donor and Host Chimerism of Each Cord Blood Unit","time_frame":"day 30, day 60, day 90","description":"Evaluate the percentages of donor and host chimerism at multiple times post-transplant including Day 30, Day 60, Day 90 and monthly thereafter if the patient is not considered to have full chimerism."},{"outcome_type":"secondary","measure":"Number of Patients Who Experience Acute and Chronic Graft-vs-host Disease After Transplant.","time_frame":"Day 30","description":"Patients will be evaluated regularly for the development of graft versus host disease both acute & chronic."},{"outcome_type":"secondary","measure":"Number of Patients Who Experience Disease Relapse Post-transplant","time_frame":"Day 100, 6 months, 1 year, 18 months, 24 months","description":"Patients will have routine restaging to assess disease response at Day 100, 6 months, 1 year, 18 months and 24 months. If disease relapse is suspected, the patient will be evaluated at that time."},{"outcome_type":"secondary","measure":"Number of Patients Who Survive Following Treatment on This Protocol","time_frame":"Through Death","description":"Patients will be followed until death"}]}
{"nct_id":"NCT01741961","start_date":"2006-06-30","enrollment":214,"brief_title":"Long Term Outcome After Ahmed Glaucoma Valve","official_title":"4-year Follow-up After Ahmed Glaucoma Valve Implantation for Lowering Intraocular Pressure in Different Types of Glaucoma","primary_completion_date":"2012-10-31","study_type":"Observational","rec_status":"Completed","completion_date":"2012-10-31","last_update":"2012-12-05","description":"Long term results after Ahmed glaucoma valve implantation for uncontrolled glaucoma are retrospectively examined.","other_id":"Ahmed-LTO","observational_model":"Case-Control","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients suffering from uncontrolled glaucoma, most often after multiple ocular surgery.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients suffering from medically uncontrolled glaucoma\r\n\r\n          -  Informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  healthy subjects\r\n\r\n          -  under 18 years\r\n      ","sponsor":"Technische Universitt Dresden","sponsor_type":"Other","conditions":"Glaucoma","interventions":[{"intervention_type":"Procedure","name":"Procedure: Ahmed valve","description":"The flexible plate 7 (FP7) model (New World Medical) was implanted in patients with uncontrolled glaucoma."}],"outcomes":[{"outcome_type":"primary","measure":"intraocular pressure reduction","time_frame":"4 years","description":"The reduction of intraocular pressure after Ahmed glaucoma valve implantation is observed over a period of 4 years."},{"outcome_type":"secondary","measure":"development of visual acuity","time_frame":"4 years","description":"The development of visual acuity after Ahmed glaucoma valve implantation is being examined over a period of 4 years."},{"outcome_type":"other","measure":"reduction of glaucoma medication","time_frame":"4 years","description":"The number of glaucoma medication after Ahmed glaucoma valve implantation are being examined over a period of 4 years."},{"outcome_type":"other","measure":"postoperative complications","time_frame":"4 years","description":"Possible postoperative complications after Ahmed glaucoma valve implantation are being examined over a period of 4 years."},{"outcome_type":"other","measure":"need for revision operation","time_frame":"4 years","description":"The need for revision operations after Ahmed glaucoma valve implantation is being examined over a period of 4 years."}]}
{"nct_id":"NCT00461032","start_date":"2006-06-30","phase":"Phase 3","enrollment":1162,"brief_title":"Montelukast Back to School Asthma Study (0476-340)","official_title":"A Multicenter, Randomized, Double-blind, Placebo-Controlled Parallel Group 8-week Study to Evaluate the Efficacy and Safety of Chewable Montelukast When Initiated at the Start of the School Year in Pediatric Patients With Chronic Asthma","primary_completion_date":"2006-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2006-11-30","last_update":"2017-03-03","description":"This study, in children with chronic asthma, evaluates the number of days of worsening asthma during 8 weeks of treatment with montelukast after treatment is started for the first day of school.","other_id":"0476-340","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":6,"maximum_age":14,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male and female non-smoking Participants, ages 6 to 14 years, with chronic asthma,\r\n             history of at least one asthma exacerbation associated with a cold within the past\r\n             year and a documented history of asthma that required treatment with any asthma\r\n             medication within 6 months prior to Visit 1\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Participant cannot have any other acute or chronic pulmonary disorder, or\r\n             hospitalization for asthma more than three times within one year prior to signing\r\n             informed consent\r\n      ","sponsor":"Merck Sharp & Dohme Corp.","sponsor_type":"Industry","conditions":"Asthma","interventions":[{"intervention_type":"Drug","name":"Drug: montelukast","description":"montelukast 5 mg tablet Once a day (QD) for 8 weeks"},{"intervention_type":"Drug","name":"Drug: Comparator: Placebo","description":"Placebo to montelukast QD for 8 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants","time_frame":"8 Week treatment period initiated at the beginning of a school year","description":"A day of worsening asthma is a day with: increase from baseline in β-agonist use (> 70% and a min increase of 2 puffs); > 50% increase from baseline in daytime symptoms score; awake \"all night\"; increase from baseline in inhaled corticosteroid use ≥ 100% or oral corticosteroid rescue for worsening asthma; or unanticipated healthcare utilization."},{"outcome_type":"secondary","measure":"Number of Participants With the Occurrence of One or More Health Care Utilizations (as Measured on Daily Diaries)","time_frame":"8 Week treatment period initiated at the beginning of a school year","description":"Health care utilization is defined as unanticipated asthma care in an office or clinic, emergent or hospital setting."},{"outcome_type":"secondary","measure":"Percentage of Days With Increased β-agonist Use by >70% and a Minimum Increase of 2 Puffs From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants","time_frame":"8 Week treatment period initiated at the beginning of a school year"},{"outcome_type":"secondary","measure":"Percentage of Days With Increased Daytime Asthma Symptom Score by >50% From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants","time_frame":"8 Week treatment period initiated at the beginning of a school year","description":"Daytime asthma symptom score was calculated as the sum of the responses (0 (best) to 5 (worst)) to three daytime symptom questions."}]}
{"nct_id":"NCT00301561","start_date":"2006-05-31","phase":"Phase 3","enrollment":459,"brief_title":"Antiretroviral Treatment Simplified Follow-up Management Assessment (ANRS 12110 STRATALL)","official_title":"Expanded Access to Antiretroviral Therapy in Africa: Assessment of the Patients' Management in District Hospitals With a Simplified Follow-up Approach (ANRS 12110 STRATALL)","primary_completion_date":"2010-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-10-31","last_update":"2016-07-22","description":"Access to antiretroviral therapy (ART) is still limited in Africa (11% of patients in immediate need in June 2005). Face to the scope of the need and the constraints (unavailability and cost of viral load and CD4 cell count, lack of physicians), WHO has developed a follow-up approach based on a simplified monitoring. However, this \"simplified\" approach which represents a major stake for the expanded access to ART has been little evaluated against the gold standard approach.","other_id":"ANRS 12110 STRATALL","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Men or women aged at least 18 years\r\n\r\n          -  Living in the health district of the hospital attended\r\n\r\n          -  Confirmed HIV-1 group M infection\r\n\r\n          -  Meeting one of the following criteria:\r\n\r\n               -  Stage III or IV (WHO classification)\r\n\r\n               -  Stage II (WHO classification) and total lymphocytes count  1200/mm3\r\n\r\n          -  Patient agreeing on monthly follow-up and treatment for 24 months\r\n\r\n          -  Signed informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  HIV-1 group O or N, or HIV-2 infection\r\n\r\n          -  HIV-1 primary infection\r\n\r\n          -  Progressive tuberculosis in treatment and total lymphocytes count > 1200/mm3\r\n\r\n          -  Progressive tumor or malignant lymphoma (except cutaneous or mucous Kaposi sarcoma)\r\n\r\n          -  Progressive psychiatric disorder\r\n\r\n          -  Hepatocellular disorder\r\n\r\n          -  History of antiretroviral therapy\r\n\r\n          -  Pregnancy\r\n      ","sponsor":"French National Agency for Research on AIDS and Viral Hepatitis","sponsor_type":"Other","conditions":"HIV Infections|AIDS","interventions":[{"intervention_type":"Procedure","name":"Procedure: Simplified follow-up approach of ARV treatment","description":"Simplify treatment follow-up :\r\nsome clinical consultations will be performed by nurses under the physicians' responsibility ;\r\nthe CD4 cell count and HIV-1 viral load will not be available for the management of patients ;\r\nthe biologic assessment for tolerability will be limited"},{"intervention_type":"Procedure","name":"Procedure: Standard follow-up approach of ARV treatment","description":"Standard treatment follow-up :\r\nall clinical consultations will be performed by physicians ;\r\nthe CD4 cell count and HIV-1 viral load will be available for the patients management routinely ;\r\nthe biologic assessment for tolerability will be available as needed"}],"outcomes":[{"outcome_type":"secondary","measure":"Impact on patients' daily life","time_frame":"Through out the trial"},{"outcome_type":"secondary","measure":"Cost-effectiveness ratio","time_frame":"24 months"},{"outcome_type":"secondary","measure":"Percentage of patients with drug resistance","time_frame":"12 and 24 months"},{"outcome_type":"secondary","measure":"Acceptability by the patients and health professionals of both approaches","time_frame":"12 and 24 months"},{"outcome_type":"primary","measure":"Increase in the CD4 cell count measured with a FACSCount apparatus after 24 months of antiretroviral therapy","time_frame":"24 months"},{"outcome_type":"secondary","measure":"Percentage of patients with viral load below 400 copies/ml and 50 copies/ml, respectively (Abbott RealTime HIV-1)","time_frame":"12 and 24 months"},{"outcome_type":"secondary","measure":"Survival probability","time_frame":"Through out the trial"},{"outcome_type":"secondary","measure":"Probability of treatment interruption","time_frame":"Through out the trial"},{"outcome_type":"secondary","measure":"Probability of patients lost to follow-up","time_frame":"Through out the trial"},{"outcome_type":"secondary","measure":"Incidence of side effects","time_frame":"Through out the trial"},{"outcome_type":"secondary","measure":"Incidence of clinical events (WHO stage III or IV)","time_frame":"Through out the trial"},{"outcome_type":"secondary","measure":"Percentage of adherence","time_frame":"12 and 24 months"}]}
{"nct_id":"NCT00484900","start_date":"2006-05-31","phase":"Phase 3","enrollment":1390,"brief_title":"Multi-Centre Trial Comparing Three Artemisinin-Based Combination Treatments on P. Falciparum Malaria","official_title":"Open Randomized Multi-Centre Trial, Comparing Artesunate-Sulfamethoxypyrazine-Pyrimethamine FDC Over 3 Days, Artesunate-Sulfamethoxypyrazine-Pyrimethamine FDC Over 48 Hours and Artemether-Lumefantrine FDC Over 3 Days on P. Falciparum Malaria","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-05-31","last_update":"2008-03-26","description":"The purpose of this open randomised multi-centre clinical trial is to test the hypothesis that three pills of the fixed dose combination artesunate/sulfamethoxypyrazine/pyrimethamine, administered over 24 hours is not inferior in efficacy to the same drug administered over 48 hours and that the fixed dose combination artesunate/sulfamethoxypyrazine/pyrimethamine As/SMP fdc, independently of the duration of its dose interval, is not inferior in efficacy to 6 - 24 pills (number of pills administered to respectively children and adults)of the 60 hours treatment of artemether/lumefantrine for the treatment of uncomplicated P. falciparum malaria.","other_id":"2005/57/01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":0.5,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  age at least 6 months,\r\n\r\n          -  weight at least 5 kg,\r\n\r\n          -  residing in one of the four countries (Mali, Cameroon, Sudan, Rwanda),\r\n\r\n          -  able to receive oral treatment,\r\n\r\n          -  having an axillary body temperature of more than 37,5 degrees Celsius or history of\r\n             fever within the proceeding 24 hours,\r\n\r\n          -  suffering from a mono specific P. falciparum infection with a parasite density between\r\n             2000 and 200000 asexual forms per micro litre of blood.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  presence of severe or complicated malaria (WHO 2000),\r\n\r\n          -  severe concomitant pathology or one that needs a medical follow-up incompatible with\r\n             the study,\r\n\r\n          -  allergic to one of the drugs involved in this study,\r\n\r\n          -  pregnant (reported pregnancy, detected clinically or with the  HCG test),\r\n\r\n          -  use of one of the anti-malaria drugs involved in this study during 28 days preceding\r\n             inclusion.\r\n      ","sponsor":"Dafra Pharma","sponsor_type":"Industry","conditions":"Plasmodium Falciparum Malaria","interventions":[{"intervention_type":"Drug","name":"Drug: Co-Arinate FDC"},{"intervention_type":"Drug","name":"Drug: Coartem"}],"outcomes":[{"outcome_type":"primary","measure":"PCR corrected Adequate Clinical and Parasitological Response","time_frame":"on day 28 (follow-up period)"},{"outcome_type":"primary","measure":"Early treatment failure","time_frame":"between day 0 and day 3"},{"outcome_type":"primary","measure":"Late clinical failure","time_frame":"between day 4 and day 28"},{"outcome_type":"primary","measure":"Late parasitological failure","time_frame":"between day 7 and day 28"},{"outcome_type":"secondary","measure":"Parasitic clearance","time_frame":"28 day follow-up period"},{"outcome_type":"secondary","measure":"Fever clearance","time_frame":"28 day follow-up period"},{"outcome_type":"secondary","measure":"Parasitological re-infection","time_frame":"28 day follow-up period"},{"outcome_type":"secondary","measure":"Gametocyte carriage","time_frame":"28 day follow-up period"},{"outcome_type":"secondary","measure":"Safety - Adverse events","time_frame":"28 day follow-up period"},{"outcome_type":"secondary","measure":"Haemoglobin levels","time_frame":"28 day follow-up period"},{"outcome_type":"secondary","measure":"Clinical and biological tolerance (Haemogram + Lever tests)","time_frame":"28 day follow-up period"}]}
{"nct_id":"NCT00374751","start_date":"2006-05-31","phase":"Phase 1/Phase 2","enrollment":29,"brief_title":"Effect of Samarium on the Relief of Pain Due to Vertebral Metastases","official_title":"Phase I/II Study of the Use of Vertebral Intracavitary Cement and Samarium (VICS) for Painful Vertebral Metastases","primary_completion_date":"2014-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-01-31","last_update":"2019-08-26","description":"Cancer cells may spread from the primary site to the vertebrae resulting in their deformity. The standard treatment for this case is removal of the cancer deposits in the vertebra and filling the induced cavity with a cement like substance. The investigators are studying the effects (good or bad) of adding samarium (a radioactive substance) to the cement that is injected into the induced cavity.","other_id":"NYM-354","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  The patient must be 18 years of age or older\r\n\r\n          -  The patient must have histologically proven malignancy in the primary site (breast,\r\n             prostate, or lung)\r\n\r\n          -  The patient must have a radiographic evidence of bone metastasis, and this must have\r\n             been performed within 8 weeks prior to enrollment in the study. Acceptable studies\r\n             include plain radiographs, radionuclide bone scans, computed tomography scans,\r\n             magnetic resonance imaging, and PET-CT scans.\r\n\r\n          -  The patient must have an intact anterior wall of spinal canal\r\n\r\n          -  The patient must have significant pain (score 6 or above,)which appears to be related\r\n             to the radiographically documented metastatic vertebra(e) in concern, as measured by\r\n             the \"Visual Analog Scale\"\r\n\r\n          -  The patient must be surgically and medically accepted for vertebroplasty/kyphoplasty\r\n             operation\r\n\r\n          -  Karnofsky Performance status >40\r\n\r\n          -  Expected life expectancy of 6 months or greater, as estimated by the physician in\r\n             charge.\r\n\r\n          -  The patient must sign a study specific informed consent prior to enrollment\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Epidural soft tissue component\r\n\r\n          -  Patients with vertebral metastases and with clinical or radiographic evidence of\r\n             spinal cord or cauda equina impingement (effacement) or compression\r\n\r\n          -  Inability to undergo anesthesia\r\n\r\n          -  Hematologic primary malignancies Patients received systemic radiotherapy (89SR or\r\n             153SM)within 30 days prior to enrollmen\r\n      ","sponsor":"New York Presbyterian Brooklyn Methodist Hospital","sponsor_type":"Other","conditions":"Cancer|Metastasis|Pain","interventions":[{"intervention_type":"Drug","name":"Drug: Samarium (153SM)","description":"The Samarium is introduced into the vertebral cavity using a 2-way valve by the radiation oncologist. The cement is then introduced via the same 2-way valve into the vertebral cavity by the neurosurgeon."}],"outcomes":[{"outcome_type":"primary","measure":"To determine the effect of intravertebral injection of Samarium on the relief of pain","time_frame":"6 months","description":"Measuring the pain by the Visual Analogue Scale"}]}
{"nct_id":"NCT00322478","start_date":"2006-04-30","phase":"Phase 2/Phase 3","enrollment":432,"brief_title":"Diabetes Technology Study of Real-Time Glucose Alerts in the Team Management of Diabetes","official_title":"Non-Significant Risk Investigational Device Study of the Wireless GlucoMON Glucose Meter Accessory and Real-time Blood Glucose Alerts as an Enabling Technology for People Who Team Manage Diabetes","primary_completion_date":"2015-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-10-31","last_update":"2015-11-03","description":"Many people with diabetes have a desire to share blood glucose data with other members of their team. Using a unique wireless glucose meter device, real-time wireless alerts may be automatically sent to a specific team of interested caregivers whom the patient selects. Additionally, trending reports can be automatically delivered to any number of authorized patient caregivers to facilitate more frequent review of glycemic control. This study is recruiting patients from throughout the USA including Hawaii and Alaska.","other_id":"DIRB1-2006-1","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Informed Consent/Assent Form Completion including signature(s) required prior to final\r\n             enrollment\r\n\r\n          -  Previously diagnosed with diabetes (any type)\r\n\r\n          -  Participant must be willing to subsidize a portion of the cost of the research by\r\n             agreeing to a participant fee\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Since the study device depends on nationwide wireless network coverage, only those\r\n             patients who reside within the wireless network coverage area will be allowed to\r\n             participate in this study. The Investigator will confirm adequate coverage based on\r\n             zip code prior to enrollment.\r\n      ","sponsor":"Diabetech","sponsor_type":"Industry","conditions":"Diabetes Mellitus, Type 1","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Automated informatics driven education and social networking","description":"The patient uses a self-contained wireless accessory to a standard blood glucose meter. This device manages the meter to ensure accurate time stamps and transmits the data to a centralized data management system. The system is then configured to assess the data and take automated steps to derive relevant diabetes education and/or send reports to a registered and authorized team."},{"intervention_type":"Behavioral","name":"Behavioral: Blood Glucose Notifications to Remote Caregivers","description":"When children with type 1 diabetes are at school they will connect their blood glucose meter to the GlucoMON appliance. The data from the meter is then transmitted to the central system followed by the most recent blood sugar being sent to the primary caregiver's email address(es) as a plain text message. The investigator is interested to better understand the behaviors that accompany the expectation of the message and actions taken subsequent to receipt of the message by the patient-centric team."},{"intervention_type":"Behavioral","name":"Behavioral: Frequency of Pattern Management","description":"The behavioral intervention being studied involves the assessment of frequency of self-care in relation to the primary and secondary outcomes including overall blood sugar control and patient satisfaction."}],"outcomes":[{"outcome_type":"primary","measure":"Blood Sugar Control","time_frame":"Daily and Quarterly"},{"outcome_type":"primary","measure":"Patient Satisfaction","time_frame":"Quarterly"},{"outcome_type":"secondary","measure":"A1c","time_frame":"Quarterly"},{"outcome_type":"secondary","measure":"Self-Test Frequency of SMBG","time_frame":"Daily"},{"outcome_type":"secondary","measure":"Standard Deviation of A1c and SMBG","time_frame":"Daily via MAGE if eligible for analysis"}]}
{"nct_id":"NCT00344045","start_date":"2006-04-30","phase":"Phase 4","enrollment":86,"brief_title":"Study to Evaluate The Analgesic Efficacy and Safety of Intravenous Paracetamol in Subjects With Postoperative Pain After Total Hip Arthroplasty","official_title":"A Phase IV, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Analgesic Efficacy And Safety of IV Paracetamol Versus Placebo in Subjects With Postoperative Pain After Total Hip Arthroplasty","primary_completion_date":"2008-02-29","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-02-29","last_update":"2015-11-04","description":"The main purpose is to evaluate the analgesic efficacy of 1g of intravenous (Iv) paracetamol versus i.v. placebo, administered every 6h, as measured by the reduction of the 24-hour cumulative dose of the opioid tramadol in the treatment of postoperative pain following total hip arthroplasty.","other_id":"CN145-010","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Spinal anesth\r\n\r\n          -  BMI 10-35\r\n\r\n          -  No pain conditions/concom med may alter pain quantif.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Other add. surgery\r\n\r\n          -  Liver/Renal function altered\r\n\r\n          -  coagulation alterations\r\n\r\n          -  Respir / Cardiac insufficiency\r\n\r\n          -  Agents affecting microsomal syst\r\n      ","sponsor":"Bristol-Myers Squibb","sponsor_type":"Industry","conditions":"Pain","interventions":[{"intervention_type":"Drug","name":"Drug: Placebo","description":"IV Solution, Intravenous, 100 mL (0 mg/mL), 4 times at 6-hour intervals, 24 hours"},{"intervention_type":"Drug","name":"Drug: Paracetamol","description":"IV Solution, Intravenous, 100 mL (10 mg/mL), 4 times at 6-hour intervals, 24 hours"}],"outcomes":[{"outcome_type":"primary","measure":"24-hour cumulative dose of tramadol","time_frame":"24 hours, defining TO as the start time of the first dose of study drug"},{"outcome_type":"secondary","measure":"Sum of tramadol and Boluses number, Time from study drug start to tramadol start, total opioid use, Pain intensity scores/diff. from baseline, Global efficacy evaluation, Number of AE, Sedation level, Nausea/Vomiting, Antiemetic needs.","time_frame":"24 hours, defining TO as the start time of the first dose of study drug"}]}
{"nct_id":"NCT00371735","start_date":"2006-04-30","phase":"Phase 3","enrollment":900,"brief_title":"Chlorproguanil-Dapsone-Artesunate (CDA) Versus Chlorproguanil-Dapsone (LAPDAP) For Uncomplicated Malaria","official_title":"A Multi-centre, Randomised, Double-blind Study to Compare the Efficacy and Safety of Chlorproguanil-dapsone-artesunate Versus Chlorproguanil-dapsone in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Children, Adolescents and Adults in Africa.","primary_completion_date":"2007-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-05-31","last_update":"2016-12-05","description":"CDA is a combination of chlorproguanil, dapsone and artesunate, being developed in a public-private partnership with the Medicines for Malaria Venture (MMV), World Health Organisation (WHO-TDR) and academic partners from the London School of Hygiene and Tropical Medicine, University of Liverpool and the Liverpool School of Tropical Medicine as a treatment for acute uncomplicated P. falciparum malaria. The combination of chlorproguanil HCl (CPG) and dapsone (DDS) as chlorproguanil-dapsone has already been shown to be efficacious against P.falciparum in adults and children in Sub-Sahara Africa. The addition of artesunate to LAPDAP has been demonstrated to increase the parasite kill rate as demonstrated in the phase II study, and reduce the chance of any parasites escaping treatment over the 3-day course. The addition of artesunate is also anticipated to have the population benefit of protection against the development of resistant strains of P.falciparum, although it will not be possible to demonstrate this in a clinical trial. One further population benefit of the artemisinin drugs are their ability to suppress the sexual forms of the parasite (gametocytes), which should reduce infectivity after antimalarial treatment and potentially lower transmission rates with widespread use, including the spread of any parasites resistant to the partner drug. The aims of this phase III study are to compare the efficacy of a fixed ratio combination tablet of CDA to chlorproguanil-dapsone, and collect supporting safety data. This will be a multi-centre, double-blind, double-dummy, randomised trial, in children, adolescents and adults, with chlorproguanil-dapsone as a comparator.","other_id":"CDA 714703/006","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":1,"population":"","criteria":"\n        Inclusion criteria:\r\n\r\n          -  Acute, uncomplicated P.falciparum malaria, microscopically confirmed infection.\r\n\r\n          -  Temperature at screening of 37.5oC or over or confirmed history of fever within\r\n             previous 24-hours.\r\n\r\n          -  Weight 7.5kg or over , no upper weight limit.\r\n\r\n          -  Screening haemoglobin (Hb) of 7g/dl, or more or haematocrit of 25% or over(if Hb not\r\n             available at screening).\r\n\r\n          -  Willingness to comply with the study visits and procedures, as outlined in the\r\n             informed consent form.\r\n\r\n          -  Written or oral witnessed consent obtained from subject, parent or guardian.\r\n\r\n          -  Assent is given by a child aged 12 to <18years, in addition to the consent of their\r\n             parent or guardian.\r\n\r\n        Exclusion criteria:\r\n\r\n          -  Features of severe/complicated falciparum malaria.\r\n\r\n          -  Hypersensitivity to active substances (chlorproguanil, dapsone, artesunate), or\r\n             excipients of the investigational products.\r\n\r\n          -  Known allergy to biguanides, sulphones, sulphonamides or artemisinin derived products.\r\n\r\n          -  Known history of G6PD deficiency.\r\n\r\n          -  Infants with a history of hyperbilirubinaemia during the neonatal period.\r\n\r\n          -  Evidence of any concomitant infection at the time of presentation (including P. vivax,\r\n             P. ovale and P. malariae).\r\n\r\n          -  Use of concomitant medications that may induce haemolysis or haemolytic anaemia from\r\n             the WHO (World Health Organization) list of essential drugs.\r\n\r\n          -  Any other underlying disease that may compromise the diagnosis and the evaluation of\r\n             the response to the study medication (including clinical symptoms of\r\n             immunosuppression, tuberculosis, bacterial infection; cardiac or pulmonary disease).\r\n\r\n          -  Malnutrition, defined as a child whose weight-for-height is below -3 standard\r\n             deviations or less than 70% of the median of the NCHS/WHO normalised reference values\r\n\r\n          -  Treatment within the past three months with mefloquine or\r\n             mefloquine-sulphadoxine-pyrimethamine; twenty-eight days with\r\n             sulphadoxine/pyrimethamine, sulfalene/pyrimethamine, lumefantrine or\r\n             artemether/lumefantrine, amodiaquine, atovaquone or atovaquone/proguanil,\r\n             halofantrine; 14-days with chlorproguanil/dapsone, or 7-days with quinine (full\r\n             course), proguanil, artemisinin, tetracycline doxycycline or clindamycin.\r\n\r\n          -  Positive sulphadoxine/pyrimethamine urine screen for 'unknown' antimalarial drug use\r\n             in prior 28-days.\r\n\r\n          -  Use of an investigational drug within 30 days or 5 half-lives whichever is the longer.\r\n\r\n          -  Previous participation in this study.\r\n\r\n          -  Female subjects of child-bearing potential who have had a positive pregnancy test at\r\n             enrolment, or do not give their consent to take a pregnancy test.\r\n\r\n          -  Female subjects who will be breast-feeding an infant for the duration of the study.\r\n      ","sponsor":"GlaxoSmithKline","sponsor_type":"Industry","conditions":"Malaria, Falciparum","interventions":[{"intervention_type":"Drug","name":"Drug: chlorproguanil-dapsone-artesunate"},{"intervention_type":"Drug","name":"Drug: chlorproguanil-dapsone"}],"outcomes":[{"outcome_type":"primary","measure":"Parasitological cure rate, PCR-corrected, at day 28, in the per-protocol population. Parasitological cure rate is defined as the clearance of the initial malaria infection by day 7 and remaining free of this infection to the day of assessment."},{"outcome_type":"secondary","measure":"The proportion of subjects with parasites remaining at 24 hours post-first dose by treatment group. Parasitological cure rate, PCR-corrected, at day 14, by treatment group."}]}
{"nct_id":"NCT00312741","start_date":"2006-04-30","enrollment":250,"brief_title":"Usefulness of Microbiological Tests in Community-Acquired Pneumonia","official_title":"Prospective Study on Benefits Derived From Microbiological Tests in Community-Acquired Pneumonia","study_type":"Observational","rec_status":"Unknown status","completion_date":"2008-05-31","last_update":"2009-02-27","description":"The hypothesis is that community-acquired pneumonia is usually a monomicrobial infection. Therefore, early detection of the etiology allows to select the most active, narrow-spectrum, and cheap, and less toxic antibiotic agent.","other_id":"pneumonia1","time_perspective":"Prospective","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age: 18 years and above\r\n\r\n          -  Clinical and radiological diagnosis of community-acquired pneumonia\r\n\r\n          -  Informed consent of patient\r\n\r\n          -  Hospital admission\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior hospital admission (less than 15 days)\r\n\r\n          -  Alternative diagnosis at the discharge\r\n\r\n          -  Immunosuppression (HIV infection, immunosuppressive therapies, neutropenia)\r\n\r\n          -  Risk factors for unusual etiologies\r\n\r\n          -  Patient is pregnant\r\n      ","sponsor":"Hospital Arnau de Vilanova","sponsor_type":"Other","conditions":"Community-Acquired Pneumonia","interventions":[{"intervention_type":"Procedure","name":"Procedure: empirical versus microbiological guided treatment"}],"outcomes":[{"outcome_type":"primary","measure":"Clinical and economic consequences obtained with the antibiotic selection in basis to early mcrobiological results"},{"outcome_type":"secondary","measure":"Importance of polimicrobial etiology in community-acquired pneumonia"},{"outcome_type":"secondary","measure":"Practice usefulness of urinary antigen detection tests in pneumonia"}]}
{"nct_id":"NCT00316550","start_date":"2006-04-30","phase":"Phase 1","enrollment":24,"brief_title":"Pilot Study to Assess the Effects of AV608 on Irritable Bowel Syndrome","official_title":"A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Pilot Study to Assess the Effects of AV608 on Central Processing of Visceral Stimuli in Subjects With Irritable Bowel Syndrome","primary_completion_date":"2007-06-30","study_type":"Interventional","rec_status":"Terminated","completion_date":"2007-09-30","last_update":"2008-02-25","description":"The purpose of this study is to assess the effects of AV608, a neurokinin 1 (NK-1) antagonist, in subjects with Irritable Bowel Syndrome.","other_id":"AV608-107","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Female, 18 to 65 years of age, inclusive\r\n\r\n          -  Current diagnosis of Irritable Bowel Syndrome (IBS)\r\n\r\n          -  Subjects 50 years of age or older must have had a barium enema and flexible\r\n             sigmoidoscopy or a colonoscopy and provide a record of this test\r\n\r\n          -  Willing to participate in this study as evidenced by a signed, written informed\r\n             consent form (ICF)\r\n\r\n          -  If female and of child-bearing potential, willing to avoid pregnancy and practice\r\n             adequate birth control from the time of study enrollment through at least 30 days\r\n             after the final dose of study medication\r\n\r\n          -  If female, negative pregnancy test results\r\n\r\n          -  Right handed\r\n\r\n          -  Ambulatory outpatient\r\n\r\n          -  Agrees to refrain from blood donation during the course of the study\r\n\r\n          -  Written and oral fluency in the English language\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Evidence of structural abnormality of the gastrointestinal tract or GI\r\n             diseases/conditions\r\n\r\n          -  Current evidence or diagnosis of peptic ulcer\r\n\r\n          -  Endoscopic bowel evaluation with evidence of cancer, inflammatory bowel disease, or\r\n             other structural disease\r\n\r\n          -  History of abdominal surgery such as adhesion lysis or any gastrointestinal surgery\r\n\r\n          -  History of gastroesophageal reflux disease not controlled by a stable dose of\r\n             medication\r\n\r\n          -  Any evidence of or treatment of malignancy within the previous 5 years\r\n\r\n          -  Clinical evidence of any disease that may interfere with participation in the study\r\n\r\n          -  Existence of surgical or medical conditions which interfere with the absorption,\r\n             distribution, metabolism and excretion of the study drug\r\n\r\n          -  Symptoms of a significant clinical illness within the 2 weeks prior to Screening\r\n\r\n          -  Type 1 diabetes mellitus, insulin-dependent Type 2 diabetes mellitus, and thyroid\r\n             disorders or other endocrine disorders that are not well controlled by appropriate\r\n             therapy\r\n\r\n          -  A QTc interval of greater than or equal to 450 msec at Screening\r\n\r\n          -  Presence of a psychotic disorder, bipolar disorder, alcohol or substance dependence\r\n             (other than nicotine dependence) or eating disorder within the previous year according\r\n             to DSM-IV-TR criteria\r\n\r\n          -  Seizure disorder\r\n\r\n          -  Subjects who have previously participated in a clinical trial for AV608 (previously\r\n             known as NKP608 and CGP608)\r\n\r\n          -  Positive drug test result at Screening\r\n\r\n          -  Use of investigational drugs, products or devices within 30 days prior to Screening\r\n\r\n          -  Planned use of certain drugs during the study that affect the central nervous system,\r\n             gastrointestinal motility, autonomic activity or pain sensation\r\n\r\n          -  Use of pimozide, terfenadine, astemizole, or cisapride during the study\r\n\r\n          -  Presence of moderate or severe allergy\r\n\r\n          -  Regular intake of more than 2 units of alcohol per day\r\n\r\n          -  Pregnant or breast feeding\r\n\r\n          -  Subjects with morbid obesity\r\n\r\n          -  Subjects with metal implants or large tattoo\r\n\r\n          -  Any clinically significant abnormalities on the Screening physical examination, ECG or\r\n             laboratory tests\r\n\r\n          -  Members of the investigative staff or their immediate family members\r\n\r\n          -  Any other condition that the investigator believes would jeopardize the safety or\r\n             rights of the subject or would render the subject unable to comply with the study\r\n             protocol\r\n\r\n          -  Regular use of more than 10 cigarettes per day\r\n      ","sponsor":"Avera Pharmaceuticals","sponsor_type":"Industry","conditions":"Irritable Bowel Syndrome (IBS)","interventions":[{"intervention_type":"Drug","name":"Drug: AV608"}],"outcomes":[{"outcome_type":"primary","measure":"The primary efficacy endpoint is the effect of AV608 on regional brain responses as measured by fMRI during conditioned and unconditioned visceral pain due to rectal distension."},{"outcome_type":"secondary","measure":"The effect of AV608 on regional brain responses to emotional visceral cues as measured by fMRI and the visceral pain threshold during rectal distension will be evaluated as secondary efficacy endpoints."}]}
{"nct_id":"NCT00585754","start_date":"2006-04-30","phase":"Phase 1","enrollment":75,"brief_title":"Guanfacine to Reduce Stress-Induced Cocaine/Alcohol Craving and Relapse","official_title":"Guanfacine to Reduce Stress-Induced Cocaine/Alcohol Craving and Relapse","primary_completion_date":"2016-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2016-06-30","last_update":"2016-11-30","description":"This study aims to test the preliminary efficacy of 3.0 mg of guanfacine (GFC) daily versus placebo in cocaine and/or alcohol dependent individuals. This proposal is a laboratory and treatment outcome study to examine the effects of guanfacine on brief exposure to stress, drug cues and neutral situations on cocaine/alcohol craving, mood and neurobiological reactivity in a sample of cocaine and/or alcohol dependent individuals. Guanfacine will be beneficial for reduction in stress and drug cue induced craving and related arousal. In a sample of 60 cocaine and/or alcohol dependent men and women, we propose to examine (a) differences in measures of cocaine craving, emotion state, hypothalamic-pituitary-adrenal (HPA) activation, physiological arousal and plasma catecholamine response to stress imagery and to drug cue imagery as compared to neutral imagery; (b) reduction in cocaine/alcohol abstinence symptoms; and (c) improvement in cocaine and alcohol treatment outcomes as measured by increasing abstinence, reduction in cocaine/alcohol use and increased treatment attendance. Hypothesis 1: Guanfacine will decrease stress-induced cocaine craving, negative emotions and related arousal in the laboratory as compared to placebo. Hypothesis 2a: As compared to the PLA group, the GFC group will show significant reductions in protracted withdrawal symptoms as measured by the CSSA/CIWA during the 9-week treatment period. Hypothesis 2b: As compared to the PLA group, a higher percentage of the GFC patients will remain abstinent during the 9-week treatment period with a higher percent of negative cocaine urines and alcohol-free days. Hypothesis 2c: The GFC group will show greater adherence to treatment as measured by the days in treatment as compared to the Pla group.","other_id":"0512000886","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female individuals, ages 18 and above, meeting current DSM-IV criteria for\r\n             cocaine and/or alcohol dependence.\r\n\r\n          -  COCAINE SAMPLE: meet current DSM-IV criteria for cocaine dependence; documented\r\n             positive urine toxicology screen for cocaine at intake\r\n\r\n          -  ALCOHOLIC SAMPLE: meet current DSM-IV criteria for alcohol dependence\r\n\r\n          -  Subject has voluntarily given informed consent and signed the informed consent\r\n             document.\r\n\r\n          -  Able to read English and complete study evaluations.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Meet current criteria for dependence on another psychoactive substance, excluding\r\n             nicotine and caffeine;\r\n\r\n          -  Any current use of opiates or past history of opiate abuse/dependence;\r\n\r\n          -  Current use of any psychoactive drugs, including anxiolytics, antidepressants,\r\n             naltrexone or antabuse;\r\n\r\n          -  Any psychotic disorder or current Axis I psychiatric symptoms requiring specific\r\n             attention, including need for psychiatric medications for current major depression and\r\n             anxiety disorders\r\n\r\n          -  Significant underlying medical conditions such as cerebral, renal, thyroid or cardiac\r\n             pathology which in the opinion of study physician would preclude patient from fully\r\n             cooperating or be of potential harm during the course of the study;\r\n\r\n          -  Abstinent from cocaine for more than two weeks prior to admission.\r\n\r\n          -  Hypotensive individuals with sitting blood pressure below 90/50 mmHG.\r\n      ","sponsor":"Yale University","sponsor_type":"Other","conditions":"Cocaine Dependent|Alcohol Dependent","interventions":[{"intervention_type":"Drug","name":"Drug: Guanfacine","description":"1.5mg BID"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"placebo"}],"outcomes":[{"outcome_type":"primary","measure":"stress-induced cocaine craving and negative emotions","time_frame":"5 years"},{"outcome_type":"secondary","measure":"Drug and alcohol use","time_frame":"over ninety days"}]}
{"nct_id":"NCT00297531","start_date":"2006-04-30","phase":"Phase 4","enrollment":120,"brief_title":"Study of Scaling and Root Planing With PerioWave Versus Scaling and Root Planing Alone in Chronic Periodontitis","official_title":"Photodynamic Disinfection in Combination With Scaling and Root Planing in the Treatment of Chronic Periodontitis","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2007-10-31","last_update":"2007-05-21","description":"This study is to determine whether scaling and root planing (SRP) followed by photodynamic disinfection results in improved outcomes that persist over time in adults with chronic periodontitis when compared with subjects with SRP alone.","other_id":"ORL-0605-4","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Adult male or female over the age of 18\r\n\r\n          2. Having been diagnosed with chronic periodontitis\r\n\r\n          3. >18 fully erupted teeth\r\n\r\n          4. Has had no periodontal instrumentation in the four months prior to initiation of study\r\n             treatment\r\n\r\n          5. Subject has at least 4 sites with pocket depth of 6-9 mm in at least two quadrants of\r\n             the mouth.\r\n\r\n          6. Subject is willing and able to return for treatment and evaluation procedures\r\n             scheduled throughout the course of this clinical study\r\n\r\n          7. The subject is capable of giving informed consent\r\n\r\n          8. Subject is willing to sign a consent form\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Is pregnant or nursing or who plans to become pregnant in the next 4 months\r\n\r\n          2. Having significant liver disease by subject report\r\n\r\n          3. Having an active malignancy of any type by subject report\r\n\r\n          4. Having chronic disease or diminished mental capacity that would mitigate the ability\r\n             to comply with the protocol\r\n\r\n          5. Having any significant disease (either acute or chronic) or who is taking medication\r\n             with concomitant oral manifestations that in the opinion of the investigator would\r\n             interfere with evaluation of safety or efficacy of PerioWave\r\n\r\n          6. Having an active periapical abscess or periodontal abscess or a history of acute\r\n             necrotizing ulcerative gingivitis\r\n\r\n          7. Treatment with antibiotics within the 1-month period prior to beginning the study or\r\n             any systemic condition which requires antibiotic coverage for routine periodontal\r\n             procedures (e.g. heart conditions, joint replacements, etc) by report of the subject\r\n\r\n          8. Known allergy to methylene blue\r\n\r\n          9. Has glucose-6-phosphate dehydrogenase (G6PD) deficiency by subject report\r\n\r\n         10. Currently uses anti-coagulant therapy at therapeutic doses\r\n\r\n         11. Currently uses photosensitizing medications\r\n\r\n         12. Participated in investigational treatment in the last 30 days or expectation for using\r\n             a separate investigational treatment during the time of the study\r\n      ","sponsor":"Ondine Research Laboratories","sponsor_type":"Industry","conditions":"Periodontitis","interventions":[{"intervention_type":"Device","name":"Device: PerioWave"},{"intervention_type":"Procedure","name":"Procedure: Scaling and Root Planing"}],"outcomes":[{"outcome_type":"primary","measure":"Increase in clinical attachment level","time_frame":"6, 12 weeks"},{"outcome_type":"secondary","measure":"Decrease in periodontal pocket depth","time_frame":"6, 12 weeks"},{"outcome_type":"secondary","measure":"Reduction in bleeding on probing","time_frame":"6, 12 weeks"}]}
{"nct_id":"NCT02624141","start_date":"2006-04-30","phase":"Phase 4","enrollment":10,"brief_title":"A Study of Recormon (Epoetin Beta) in Anemic Patients With Non-Myeloid Malignancy","official_title":"Open Multicentric Study to Assess the Hematopoyetic Response in Terms of Increase of Hemoglobin Levels, of Patients With Anemia Reklated to Malignant Tumors, Treated With Erythropoietin B (Recormon) Using the Pre-Filled Syringe With 30,000 IU, as Well as to Quantify Teh Risk Factors of Anemia and Its Impact on Quality of Life Related to Treatment","primary_completion_date":"2009-12-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2009-12-31","last_update":"2016-11-02","description":"This study will examine the efficacy, safety, and effect on hemoglobin levels, of once weekly epoetin beta subcutaneous injections (30,000 International Units [IU]) in anemic patients with solid tumors. The anticipated study duration is 4 months, and the target sample size is 40 individuals.","other_id":"ML18054","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adult patients with a non-myeloid malignancy\r\n\r\n          -  Anemia\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Transfusion of red blood cells within 2 months of study drug\r\n\r\n          -  Treatment-resistant hypertension\r\n\r\n          -  Acute or chronic bleeding (requiring therapy) within 3 months of study drug\r\n      ","sponsor":"Hoffmann-La Roche","sponsor_type":"Industry","conditions":"Anemia","interventions":[{"intervention_type":"Drug","name":"Drug: Epoetin Beta","description":"Dosage at Initiation: Subcutaneous injection of 30000 IU administered once a week. Dosage could be increased to 30000 IU twice a week or 60000 IU once a week after 4 weeks if a blood transfusion was required or hemoglobin level did not increase by at least 0.5 grams per deciliter (g/dL) versus baseline."}],"outcomes":[{"outcome_type":"primary","measure":"Hemoglobin Levels at 16 Weeks","time_frame":"16 Weeks"},{"outcome_type":"secondary","measure":"Serum Iron Levels","time_frame":"16 Weeks"},{"outcome_type":"secondary","measure":"Quality of Life According to Functional Assessment of Cancer Therapy - Anemia (FACT-An) Instrument","time_frame":"Up to 4 months"},{"outcome_type":"secondary","measure":"Tolerability - Incidence of Adverse Events","time_frame":"Up to 4 months"},{"outcome_type":"secondary","measure":"Serum Transferrin Levels","time_frame":"16 Weeks"},{"outcome_type":"secondary","measure":"Percentage of Participants With A Positive Response","time_frame":"16 Weeks"},{"outcome_type":"secondary","measure":"Time To Global Response","time_frame":"Up to 4 months"},{"outcome_type":"secondary","measure":"Quality of Life In Relation to Anemia Grade","time_frame":"Up to 4 months"},{"outcome_type":"secondary","measure":"Serum Ferritin Levels","time_frame":"16 Weeks"}]}
{"nct_id":"NCT00441909","start_date":"2006-04-30","phase":"Phase 1","enrollment":60,"brief_title":"Phase I Study of Safety and Persistence of UC-781 Vaginal Microbicide","official_title":"Phase I Study of the Safety and Persistence of 0.1% UC-781 Vaginal Gel in HIV-1 Seronegative Women","primary_completion_date":"2008-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-04-30","last_update":"2009-03-05","description":"Vaginal microbicides are compounds that may protect women from HIV and other sexually transmitted infections (STIs). This study will determine the safety of the microbicide UC-781 by comparing the effects of keeping the microbicide in the vagina for different lengths of time.","other_id":"U19AI051661","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria for Screening Visit:\r\n\r\n          -  HIV uninfected\r\n\r\n          -  General good health\r\n\r\n          -  Normal Pap smear within 12 months prior to screen or obtained at screening visit\r\n\r\n          -  Anatomy that lends itself easily to visualization of the cervix\r\n\r\n          -  Sexual abstinence (including vaginal, oral, and rectal) from Visit 1 to the completion\r\n             of Visit 4\r\n\r\n          -  Agree to use condoms provided by the study between Visits 4 and 5\r\n\r\n          -  Agree to abstain from the use of intravaginal products or vaginal penetration\r\n             throughout the study\r\n\r\n          -  Willing to use acceptable forms of contraception until the completion of study\r\n\r\n          -  Willing to participate in all study-related assessments and follow all study-related\r\n             procedures\r\n\r\n        Inclusion Criteria for Study Entry:\r\n\r\n          -  Meet all inclusion criteria for the screening visit at Study Entry\r\n\r\n          -  Willing to stay in the Magee-Womens Hospital Clinical Research Center (MWH CRC) for up\r\n             to 9 hours after gel insertion\r\n\r\n        Exclusion Criteria for Screening Visit:\r\n\r\n          -  Menopause (at least 12 months without menses in absence of long-acting progestin use)\r\n\r\n          -  Hysterectomy\r\n\r\n          -  Latex allergy\r\n\r\n          -  Use of a diaphragm, NuvaRing, or spermicide for contraception\r\n\r\n          -  Diagnosed urogenital infection or suspected infection 21 days prior to study\r\n             screening. More information on this criterion can be found in the protocol.\r\n\r\n          -  Menses or other vaginal bleeding anticipated in the 17 days postscreening\r\n\r\n          -  Antibiotic or antifungal therapy (vaginal or systemic) 14 days prior to study\r\n             screening\r\n\r\n          -  Injected nontherapeutic drugs 12 months prior to study screening\r\n\r\n          -  Systemic immunosuppressive drug use 60 days prior to study screening\r\n\r\n          -  Participation in drug, spermicide, and/or microbicide study 30 days prior to study\r\n             screening\r\n\r\n          -  Any condition that, in the opinion of the investigator, would interfere with the study\r\n\r\n          -  Intravaginal use of any device or product (except tampons) 7 days prior to study\r\n             screening\r\n\r\n          -  Surgical procedure involving the pelvis in the 90 days prior to enrollment (e.g.,\r\n             dilation and curettage or evacuation, cervical biopsy, cryosurgery,any other surgery\r\n             involving pelvic organs or area)\r\n\r\n          -  Abnormal pelvic exam finding that, in the opinion of the investigator would complicate\r\n             interpretation of the colposcopy\r\n\r\n          -  Pregnancy, or within 90 days of last pregnancy\r\n\r\n          -  Breastfeeding\r\n\r\n        Exclusion Criteria for Study Entry:\r\n\r\n          -  Meets any of the exclusion criteria of the screening visit\r\n\r\n          -  Diagnosed or suspected reproductive tract infection or urinary tract infection. More\r\n             information on this criterion can be found in the protocol.\r\n\r\n          -  Menses or other vaginal bleeding anticipated in the 8 days following study entry\r\n\r\n          -  Injected nontherapeutic drugs between study screening and study entry\r\n\r\n          -  Certain abnormal laboratory values\r\n      ","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","sponsor_type":"NIH","conditions":"HIV Infections","interventions":[{"intervention_type":"Drug","name":"Drug: UC-781","description":"0.1% UC-781 Vaginal Gel"},{"intervention_type":"Drug","name":"Drug: UC-781 placebo","description":"Vaginal Gel Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"Local and systemic safety of a one-time dose of UC-781 0.1 % gel for vaginal use at different durations of exposure in HIV uninfected women","time_frame":"Throughout study"},{"outcome_type":"secondary","measure":"Persistence of UC-781 0.1% gel following a single application","time_frame":"At 0, 2, 4, or 8 hours post application"},{"outcome_type":"secondary","measure":"Systemic absorption of UC-781 following a single application of 0.1% UC-781 gel","time_frame":"At 0, 2, 4, or 8 hours post application"},{"outcome_type":"secondary","measure":"In vitro anti-HIV activity of cervicovaginal lavage fluid","time_frame":"Throughout study"},{"outcome_type":"secondary","measure":"Product acceptability","time_frame":"Throughout study"},{"outcome_type":"secondary","measure":"Measurement of vaginal flora characteristics","time_frame":"Throughout study"},{"outcome_type":"secondary","measure":"Changes in vaginal flora characteristics after a timed, single exposure","time_frame":"Throughout study"}]}
{"nct_id":"NCT00735566","start_date":"2006-04-30","enrollment":240,"brief_title":"Antiangiogenic Factors in Gastric Cancer","official_title":"The Role of Endogenous Antiangiogenic Factors in Gastric Cancer Progression","primary_completion_date":"2008-07-31","study_type":"Observational","rec_status":"Completed","completion_date":"2012-01-31","last_update":"2012-10-18","description":"Endogenous antiangiogenic factors are related with gastric cancer progression.","other_id":"NCCCTS 04-105","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":20,"maximum_age":80,"population":"Eligible patients will undergo subtotal or total gastrectomy with D2 lymph node dissection","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologic diagnosis of gastric adenocarcinoma\r\n\r\n          -  No other forms of cancer therapy, such as chemotherapy or radiotherapy for at least 3\r\n             weeks before the enrollment in study\r\n\r\n          -  Performance status of 0, 1, 2 on the ECOG criteria\r\n\r\n          -  ASA class I, II\r\n\r\n          -  Patient compliance that allow adequate follow up\r\n\r\n          -  Informed consent from patient or patient's relative.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Second primary malignancy\r\n\r\n          -  EMR (Endoscopic mucosal resection) indication\r\n\r\n          -  Laparoscopic gastrectomy\r\n\r\n          -  Radiologic or clinical evidence of metastasis\r\n      ","sponsor":"National Cancer Center, Korea","sponsor_type":"Other","conditions":"Gastric Cancer","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Relationship between antiangiogenic factor and tumor, node, metastasis","time_frame":"One year"},{"outcome_type":"secondary","measure":"Overall survival, treatment failure","time_frame":"5 years"}]}
{"nct_id":"NCT00314366","start_date":"2006-04-30","phase":"Phase 1","enrollment":21,"brief_title":"Intramyocardial Injection of Autologous Aldehyde Dehydrogenase-Bright Stem Cells for Therapeutic Angiogenesis (FOCUS Br)","official_title":"Phase IB Randomized Controlled Double-Blind Trial of Intramyocardial Injection of Autologous Aldehyde Dehydrogenase-Bright Stem Cells Under Electromechanical Guidance for Therapeutic Angiogenesis","primary_completion_date":"2009-08-31","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2024-03-31","last_update":"2021-04-01","description":"Recent studies have suggested that it may be possible to grow new blood vessels (angiogenesis) to supply the heart muscle that is currently not getting enough blood. One theory is that a certain type of stem cell, aldehyde dehydrogenase bright stem cells, may stimulate the growth of new vessels. After a bone marrow procedure, the special cells are separated and then injected back into the heart around the area of damage with a special guidance and injection system. Once a patient meets all inclusion criteria and no exclusion criteria, he/she will be consented to the study and extensive baseline testing will be completed at St. Luke's Episcopal Hospital in Houston, Texas. Once all baseline criteria are met, the patient has his/her own bone marrow harvested and later injected, if randomized to receive active treatment. The day after the bone marrow harvest, the patient is taken to the cardiac catheterization lab where NOGA mapping is performed and the processed cells or placebo are injected under electromechanical guidance into the affected areas of the left ventricle. The patient is usually discharged home the next day and returns for follow-up at weeks 1 and 4, and months 3 and 6, and at one year unless there is a crossover and then he/she begins baseline again at 6 months and follow-up for one more year. Follow-up testing, including quality of life and NOGA mapping, is done at the time of injection, as well as at 6 months.","other_id":"UT-H-GEN-05-0599","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Canadian cardiovascular (CV) Class II-IV angina and/or congestive heart failure (CHF)\r\n             symptoms\r\n\r\n          -  Ejection fraction less than or equal to 45%\r\n\r\n          -  Reversible perfusion defect on single photon emission computed tomography (SPECT)\r\n\r\n          -  Coronary artery disease (CAD) unable to be corrected by surgery (bypass) or\r\n             intervention (stent)\r\n\r\n          -  Able to walk on treadmill\r\n\r\n          -  Hemodynamically stable\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Age less than 18 or greater than 70\r\n\r\n          -  Atrial fibrillation\r\n\r\n          -  Severe valve disease\r\n\r\n          -  History of cancer in last 5 years\r\n\r\n          -  HIV positive; hepatitis B or C positive.\r\n\r\n          -  Left ventricular wall thickness less than 8 mm\r\n\r\n          -  Recent heart attack within the last 30 days\r\n      ","sponsor":"Texas Heart Institute","sponsor_type":"Other","conditions":"Coronary Artery Disease","interventions":[{"intervention_type":"Biological","name":"Biological: Stem Cell Therapy","description":"Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."},{"intervention_type":"Other","name":"Other: Control (plasma)","description":"Placebo patients receive an injection of plasma (control) containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."}],"outcomes":[{"outcome_type":"secondary","measure":"Left Ventricular End-Diastolic Volume (LVEDV)","time_frame":"baseline and 6 months","description":"Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Left Ventricular End-Diastolic Volume (LVEDV)which is the volume of blood inside the left ventricle when the heart has completed its filling cycle. The volume of the left ventricle is measured during contraction and relaxation. Normal heart volume inside the left ventricle is about 140 milliliters."},{"outcome_type":"primary","measure":"Safety of Aldehyde Dehydrogenase Bright Stem Cells Versus the Control Group as Measured by Combined Early and Late Adverse Events","time_frame":"Baseline and 6 months","description":"Safety of cell injections was assessed by reviewing adverse events at 2 time points: Baseline (periprocedural period up to 2 weeks post-procedure) and at 6 months post-procedure. Major adverse events were adjudicated (hospitalization, arrhythmia, exacerbation of congestive HF [CHF], acute coronary syndrome, myocardial infarction, stroke, or death)."},{"outcome_type":"secondary","measure":"New York Heart Association (NYHA) Classification","time_frame":"Baseline and 6 months","description":"Clinical and functional assessment in endstage ischemic cardiomyopathy patients using New York Heart Association (NYHA)Classification and indicates extent of heart failure based on limitations in physical activity.\r\nClass I- No symptoms/limitation in ordinary physical activity (shortness of breath when walking, etc) Class II-Mild symptoms/slight limitation during ordinary activity Class III- Marked limitation in activity due to symptoms, even during less-than-ordinary activity Class IV- Severe limitations in activity/experiences symptoms while at rest (bedbound)"},{"outcome_type":"secondary","measure":"Canadian Cardiovascular (CCS) Angina Score","time_frame":"Baseline and 6 months","description":"Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Canadian Cardiovascular (CCS) Angina Score which indicates discomfort from angina (chest pain).\r\nClass I- Angina only during strenuous or prolonged activity Class II- Slight limitation, with angina only during vigorous physical activity Class III- Symptoms with everyday living activities (moderate limitation) Class IV- Inability to perform any activity without angina or angina at rest (severe limitation)"},{"outcome_type":"secondary","measure":"Echocardiography (EF)Percent (%)","time_frame":"Baseline and 6 months","description":"Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography measures ejection fraction(EF)as a percentage(%) of blood leaving the heart with each beat or contraction. It can provide information concerning structural characteristics and blood flow in the heart and blood vessels. A normal heart pumps 50-75% of the blood with each contraction."},{"outcome_type":"secondary","measure":"Left Ventricular End-Systolic Volume (LVESV) (ml)","time_frame":"baseline and 6 months","description":"Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Left Ventricular End-Systolic Volume (LVESV) when the blood moves from the ventricles to the atria during the contraction cycle. Measured as volume in milliliters (ml). Normal is approximately 60- 65 milliliters."},{"outcome_type":"secondary","measure":"Echocardiography Wall Motion Score Index (WMSI)","time_frame":"baseline and 6 months","description":"Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography Wall Motion Score Index (WMSI) as defined by the American Heart Association which allows detection of abnormalities in the heart wall or blood flowing through the heart. Using this model, the left ventricle is divided into 17 segments. Normal contracting Left Ventricle has WMSI of 1. Larger WMSI indicates higher degree of abnormalities (2 for hypokinetic, 3 for akinetic, 4 for dyskinetic, and 5 for aneurysmal). WMSI was calculated as the sum of scores divided by the total number of segments."},{"outcome_type":"secondary","measure":"Myocardial Oxygen Consumption (MVO2)","time_frame":"baseline and 6 months","description":"Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Myocardial Oxygen Consumption (MVO2)which is the amount of oxygen used by the heart muscle and is indicative of heart muscle function. Normal value is 15.5 Volume %. Measured as milliliters (ml) oxygen per kilogram (kg) body weight per minute."},{"outcome_type":"secondary","measure":"Echocardiography (EF) Percent (%)","time_frame":"baseline and 6 months","description":"Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography measures ejection fraction(EF)as a percentage(%) of blood leaving the heart with each beat or contraction. It can provide information concerning structural characteristics and blood flow in the heart and blood vessels. A normal heart pumps 50-75% of the blood with each contraction."},{"outcome_type":"secondary","measure":"Total Severity Score (Stress)","time_frame":"baseline and 6 months","description":"For the stress test, cardiac SPECT polar mapping (gated dual-isotope) is used to evaluate perfusion, compared against a database with a statistically significant number of polar maps of healthy hearts based on gender, data acquisition method, stress vs rest and type of data (i.e. perfusion, wall motion or wall thickening) using a clinically validated software package (J Nucl Med Technol 2006; 34:3-17). The basal and mid-ventricle heart wall is mapped by cylindrical sampling and apex mapped by spheric, cylindric and radial sampling.\r\nTotal severity score during stress is the sum of blackout pixels in the blackout polar map of myocardial perfusion during stress using cardiac SPECT imaging (adding scores in different views), weighted by the number of SDs below the mean.\r\nTotal severity score varies from 0 (normal) to several thousands although the upper limit is not well defined. A score greater than 1000 indicates poor perfusion."},{"outcome_type":"secondary","measure":"Total Severity Score (Rest)","time_frame":"baseline and 6 months","description":"For the total severity score at rest, cardiac SPECT polar mapping (gated dual-isotope) is used to evaluate myocardial cardiac perfusion, compared against a database with a statistically significant number of polar maps of healthy hearts and compared based on gender, data acquisition method, stress vs rest and type of data (i.e. perfusion, wall motion or wall thickening) using a clinically validated software package (J Nucl Med Technol 2006; 34:3-17). The basal and mid-ventricle heart wall is mapped by cylindrical sampling and apex mapped by spheric, cylindric and radial sampling at rest.\r\nTotal severity score at rest is the sum of blackout pixels in the rest blackout polar map of myocardial perfusion cardiac SPECT imaging (adding scores in different views), weighted by the number of SDs below the mean.\r\nTotal severity score varies from 0 (normal) to several thousands although the upper limit is not well defined. A score greater than 1000 indicates poor perfusion."},{"outcome_type":"secondary","measure":"Total Severity Score (Reversible)","time_frame":"baseline and 6 months","description":"For the severity test, cardiac SPECT polar mapping (gated dual-isotope) is used to evaluate myocardial cardiac perfusion, compared against a database with a statistically significant number of polar maps of healthy hearts and compared based on gender, data acquisition method, stress vs rest and type of data (i.e. perfusion, wall motion or wall thickening) using clinically validated software package (J Nucl Med Technol 2006; 34:3-17). The basal and mid-ventricle heart wall is mapped by cylindrical sampling and apex mapped by spheric, cylindric and radial sampling at rest/stress.\r\nTotal severity score is the sum of blackout pixels in rest/stress blackout polar map of myocardial perfusion cardiac SPECT imaging (adding scores in different views), weighted by number of SDs below mean. Total severity score reversible is total severity scores at rest subtracted from those during stress. The severity score varies from 0 (normal) to > 1000 (poor perfusion) but upper limit is not well defined."}]}
{"nct_id":"NCT00456573","start_date":"2006-04-30","phase":"N/A","enrollment":40,"brief_title":"Cytokine Profiles in Children With Obstructive Sleep Apnea","official_title":"Local and Systemic Cytokine Profiles in Children With Obstructive Sleep Apnea and Controls","primary_completion_date":"2008-09-30","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2008-12-31","last_update":"2008-06-03","description":"The purpose of this study is to compare the cytokine profile of tonsillar and peripheral blood mononuclear cells in patients with obstructive sleep apnea (OSA) and to compare the blood mononuclear cell cytokine secretion profile between patients with obstructive sleep apnea and controls without apnea.","other_id":"002 (14437B)","intervention_model":"Parallel Assignment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":1.5,"maximum_age":12,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  OSA documented by polysomnography and clinical symptoms.\r\n\r\n          -  Patients with no symptoms of OSA and negative sleep questionnaire.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Significant systemic disease except mild asthma\r\n      ","sponsor":"University of Chicago","sponsor_type":"Other","conditions":"Obstructive Sleep Apnea Syndrome","interventions":[{"intervention_type":"Procedure","name":"Procedure: tonsillectomy","description":"medically indicated tonsillectomy in subjects with and without OAS"}],"outcomes":[{"outcome_type":"primary","measure":"levels of cytokines released from PBMCs of OAS subjects and controls","time_frame":"just prior to surgery"},{"outcome_type":"secondary","measure":"cytokine level comparison between PBMCs and tonsillar lymphocytes within OAS groups","time_frame":"at time of surgery"}]}
{"nct_id":"NCT00695825","start_date":"2006-04-01","phase":"N/A","enrollment":30,"brief_title":"Effects the Glycemic Index on Metabolic Risk Markers","official_title":"Postprandial Effects of a Low vs. a High Glycemic Index Food Product on Metabolic Risk Markers in Lean and Obese Subjects","primary_completion_date":"2006-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-12-31","last_update":"2018-04-26","description":"Recent population studies have shown that the glycemic index (GI) of food products is positively associated with the risk of developing type 2 diabetes and cardiovascular disease (CVD). In the pathogenesis of type 2 diabetes and CVD, inflammatory processes play a pivotal role. In a previous intervention study (11 weeks), however, we found no effects of lower-GI vs. higher-GI diets on fasting inflammatory markers in subjects with increased risk of developing the metabolic syndrome. People, however, spent most of their time in the postprandial period. Therefore, there is a need to study the postprandial effects of low-GI vs. high-GI diets. In addition, it needs to be emphasized the GI is derived from studies in lean subjects, while especially overweight and obese people suffer from metabolic aberrations related to the development of type 2 diabetes and CVD. AIM: To investigate in obese subjects the postprandial effects of a low-GI vs. high-GI food product on metabolic risk markers. A second research objective is to compare these effects with those in lean subjects.","other_id":"073101","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  healthy and obese men\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  smoking\r\n      ","sponsor":"Maastricht University Medical Center","sponsor_type":"Other","conditions":"Metabolic Syndrome X","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Low GI+high GI","description":"Consumption of low GI food product on day 1 Consumption of high GI food product on day 2"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: High GI+low GI","description":"Consumption of high GI food product on day 1 Consumption of low GI food product on day 2"}],"outcomes":[{"outcome_type":"primary","measure":"inflammation markers","time_frame":"postprandial effect"},{"outcome_type":"secondary","measure":"glucose response","time_frame":"postprandial"}]}
{"nct_id":"NCT00443196","start_date":"2006-03-31","phase":"Phase 2/Phase 3","enrollment":150,"brief_title":"Testing Drug Sensitivity of Ovarian, Fallopian and Primary Peritoneal Adenocarcinomas","official_title":"Application of the Microculture Kinetic (MiCK) Assay for Apoptosis to Testing Drug Sensitivity of Ovarian, Fallopian and Primary Peritoneal Adenocarcinomas","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-09-30","last_update":"2018-03-12","description":"2.0 Study Objectives: 2.1 To evaluate the ability of the MiCK assay to predict the outcome of chemotherapy of cancer patients for first-line treatment. 2.2 To evaluate the ability of the MiCK assay to guide chemotherapy of cancer patients in a third-line, refractory treatment setting (exclusive of anti-VEGF)","other_id":"WIRB 20060042","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with pathological diagnoses of ovarian, fallopian and primary peritoneal\r\n             adenocarcinomas.\r\n\r\n          -  Patients with de novo malignancies and no previous chemotherapy\r\n\r\n          -  Patients with advanced refractory malignancies who received no more than 2 standard\r\n             chemotherapy treatment protocols.\r\n\r\n          -  Patients of any age group.\r\n\r\n          -  Patients must have tumor which is accessible and agree to undergo biopsies, or\r\n             drainage of effusions.\r\n\r\n          -  Patients for whom chemotherapy is a treatment option.\r\n\r\n          -  Explanations: We anticipate that newly diagnosed patients will be mostly used to\r\n             evaluate the ability of the MiCK assay to predict the outcome of the chemotherapy\r\n             (Objective #2.1) and to establish criteria correlating numerical response in the MiCK\r\n             assay with probability of the clinically established complete remission. The patients\r\n             with refractory malignancies will be mostly used to evaluate the ability of the MiCK\r\n             assay to guide cancer chemotherapy (Objective #2.2). Patients will be seen and managed\r\n             as outpatients or inpatients, depending on a clinical standard of the institution\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with symptomatic/uncontrolled parenchimal brain metastasis and not accessible\r\n             tumors.\r\n\r\n          -  Patients with meningeal metastasis.\r\n\r\n          -  Patients for whom chemotherapy clinically is not indicated.\r\n\r\n          -  Pregnancy. During the course of the study, all patients of childbearing potential\r\n             should be instructed to contact the treating physician if they suspect they might have\r\n             conceived a child; for females, a missing or late menstrual period should be reported\r\n             to the treating physician. If pregnancy is confirmed by a pregnancy test, the patient\r\n             must not receive study medication and must not be enrolled into the study or, if\r\n             already enrolled, must be withdrawn from the study. If a male patient is suspected of\r\n             having fathered a child while on the study drugs, the pregnant female partner must be\r\n             notified and counseled regarding the risk to the fetus. Pregnancy during the course of\r\n             this study will be reported to the Principal Investigator as a serious adverse event.\r\n             Women of child bearing potential are defined to include any female who has experienced\r\n             menarche and has not undergone successful surgical sterilization (hysterectomy,\r\n             bilateral tubal ligation, or bilateral oophorectomy) or is not post-menopausal\r\n             (defined as amenorrhea for more than 12 consecutive months); these includes also\r\n             females using oral, implanted, or injectable contraceptive hormones, mechanical\r\n             devices, or barrier methods to prevent pregnancy.\r\n      ","sponsor":"Pierian Biosciences","sponsor_type":"Industry","conditions":"Adenocarcinoma|Ovarian Neoplasms|Fallopian Tube Neoplasms|Peritoneal Neoplasms","interventions":[{"intervention_type":"Procedure","name":"Procedure: MiCK Assay","description":"Physician determined treatment"}],"outcomes":[{"outcome_type":"primary","measure":"Complete Response, No Response","time_frame":"9 months"}]}
{"nct_id":"NCT00462137","start_date":"2006-03-31","enrollment":8,"brief_title":"The Influence of Hypnotic Medications on Sleep Arousal and Its Effect on Gastroesophageal Reflux","official_title":"The Influence of Hypnotic Medications on Sleep Arousal and Its Effect on Gastroesophageal Reflux","primary_completion_date":"2008-03-31","study_type":"Observational","rec_status":"Completed","completion_date":"2008-03-31","last_update":"2019-08-05","description":"This is a continuation of a study that has already been completed in the division of gastroenterology (GI) looking at the effects of sleep medication zolpidem (Ambien) on subjects with Gastroesophageal reflux disease (GERD). That study looked at 16 subjects, 8 who had been diagnosed with GERD and 8 who did not have GERD (IRB Control #04S.41). All subjects previously had a PH probe completed in the division of GI at Thomas Jefferson University. An additional 8 subjects with GERD will be recruited to obtain more data to add to the previous study results. These subjects will undergo 2 sleep studies, one in which they will be given Ambien and one in which they will not.","other_id":"06U.101","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"subjects who have esophageal reflux","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subjects must have had a pH probe test at Thomas Jefferson University between July\r\n             2004 and January 2006 with findings consistent with GERD.\r\n\r\n          -  Male or female over the age of 18\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Hypersensitivity to zolpidem or any of its components\r\n\r\n          -  Pregnancy\r\n\r\n          -  History of depression or hypnotic/substance abuse\r\n\r\n          -  Prior esophagus or stomach surgery\r\n\r\n          -  GI tract motility disorder\r\n\r\n          -  Any sleep disorder or contraindications to the use of hypnotic medications.\r\n      ","sponsor":"Thomas Jefferson University","sponsor_type":"Other","conditions":"Gastroesophageal Reflux","interventions":[{"intervention_type":"Procedure","name":"Procedure: Sleep Studies"}],"outcomes":[{"outcome_type":"primary","measure":"Do hypnotic medications effect sleep arousal due to gi reflux?","time_frame":"48 hours"}]}
{"nct_id":"NCT00259506","start_date":"2006-03-31","phase":"N/A","enrollment":405,"brief_title":"Implementation and Evaluation of \"Mindfulness-Based Cognitive Therapy\" in a Health Care Region in Flanders: a Randomized Clinical Trial","official_title":"Implementation and Evaluation of \"Mindfulness-Based Cognitive Therapy\" in a Health Care Region in Flanders: a Randomized Clinical Trial","primary_completion_date":"2008-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-07-31","last_update":"2009-06-03","description":"Research project regarding the possibility to implement and the efficacy of a non-drug, psychotherapeutic intervention (MBCT), in preventing relapse/recurrence of depression.","other_id":"2005/195","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age: 18 years and above\r\n\r\n          -  place of residence in accordance with a well-defined region (pilot study)\r\n\r\n          -  given informed consent\r\n\r\n          -  diagnosis of recurrent depression (DSM-IV-TR)\r\n\r\n          -  at least 3 depressive episodes in the anamnesis (depression: either primary or\r\n             secondary diagnosis)\r\n\r\n          -  last depressive episode at least 8 weeks ago (DSM-IV-TR)\r\n\r\n          -  absence of a present depressive episode\r\n\r\n          -  history of treatment by an antidepressant medication\r\n\r\n          -  HRSD-score <14 at baseline assessment (Hamilton Rating Scale for Depression, HRSD-17)\r\n\r\n          -  absence of exclusion criteria\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  based on DSM-IV-TR: current diagnosis of any of the following psychiatric disorders:\r\n             lifetime mood disorder, chronic depression, dysthymia, current substance abuse,\r\n             obsessive-compulsive disorder, bipolar disorder, acute psychosis, cognitive disorder,\r\n             organic mental disorder, pervasive developmental disorder, mental retardation, primary\r\n             diagnosis of axis-II-disorder, at risk for suicide\r\n\r\n          -  Extended experience with zen- or vipassana meditation (or mindfulness) in the past or\r\n\r\n          -  more than 1 hour practice of zen- or vipassana meditation (or mindfulness) per week\r\n             during the last 8 weeks\r\n\r\n          -  other meditation practices except for MBCT during the training\r\n\r\n          -  more than 1 psychiatric consultation per 3-4 weeks during the training and follow-up\r\n\r\n          -  intensive psychotherapy during the training and follow-up\r\n\r\n          -  schizophrenia or schizoaffective disorder in the anamnesis\r\n\r\n          -  physical problems which make it difficult to participate in the programme\r\n      ","sponsor":"University Hospital, Ghent","sponsor_type":"Other","conditions":"Recurrent Depression","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)"}],"outcomes":[{"outcome_type":"primary","measure":"Feasibility to implement MBCT in a Flemish region"},{"outcome_type":"primary","measure":"Relapse/recurrence of depression after approximately 12 months"},{"outcome_type":"secondary","measure":"Health status"},{"outcome_type":"secondary","measure":"Quality of life"},{"outcome_type":"secondary","measure":"Coping"},{"outcome_type":"secondary","measure":"Fear"},{"outcome_type":"secondary","measure":"Rumination"}]}
{"nct_id":"NCT00524121","start_date":"2006-03-31","phase":"Phase 2","enrollment":22,"brief_title":"Erlotinib and Radiation Therapy in Treating Older Patients With Stage I, Stage II, Stage III, or Stage IV Esophageal Cancer","official_title":"Phase II Study of Erlotinib (Tarceva) and Radiotherapy for Elderly Patients With Esophageal Carcinoma","primary_completion_date":"2010-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-10-31","last_update":"2016-04-14","description":"RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving erlotinib together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving erlotinib together with radiation therapy works in treating older patients with stage I, stage II, stage III, or stage IV esophageal cancer.","other_id":"CDR0000563268","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":65,"maximum_age":120,"population":"","criteria":"\n        DISEASE CHARACTERISTICS:\r\n\r\n          -  Biopsy-proven primary squamous cell carcinoma or adenocarcinoma of the esophagus or\r\n             gastroesophageal (GE) junction\r\n\r\n               -  GE junction tumors with 50% or more tumor located in the esophagus determined by\r\n                  radiologic or endoscopic evaluation\r\n\r\n               -  Stage I-IVA disease determined by CT scan or MRI of the chest and abdomen\r\n\r\n                    -  Stage IVB disease allowed if metastases to distant regional lymph nodes\r\n                       (celiac or cervical) only and no other sites\r\n\r\n          -  Not a surgical candidate and ineligible for chemotherapy due to any of the following:\r\n\r\n               -  Neuropathy\r\n\r\n               -  Cardiac disease\r\n\r\n               -  Performance status 2\r\n\r\n               -  General overall condition felt by the investigator to be a contraindication to\r\n                  platinum-based therapy\r\n\r\n          -  Bronchoscopy with biopsy and cytology required if primary esophageal cancer is < 26 cm\r\n             from incisors\r\n\r\n          -  No evidence of clinically active interstitial lung disease (patients who are\r\n             asymptomatic with chronic, stable, radiographic lung changes allowed)\r\n\r\n        PATIENT CHARACTERISTICS:\r\n\r\n          -  ECOG performance status 0-2\r\n\r\n          -  Life expectancy > 4 months\r\n\r\n          -  WBC  3,000/mm\r\n\r\n          -  ANC  1,500/mm\r\n\r\n          -  Platelet count > 100,000/mm\r\n\r\n          -  Bilirubin  1.3 mg/dL\r\n\r\n          -  ALT and AST  2.5 times upper limit of normal (ULN)\r\n\r\n          -  Alkaline phosphatase  2.5 times ULN\r\n\r\n          -  No prior malignancies except basal cell or squamous cell skin cancer, in situ cervical\r\n             cancer, or superficial transitional cell bladder cancer, unless diagnosed and/or\r\n             treated > 2 years prior to current study and are without evidence of recurrence\r\n\r\n          -  No history of allergy to erlotinib or any of its excipients\r\n\r\n          -  No serious, uncontrolled, concurrent infection\r\n\r\n          -  No clinically serious, uncontrolled medical conditions that the investigator feels\r\n             might compromise study participation\r\n\r\n          -  No lack of physical integrity of the upper gastrointestinal tract or malabsorption\r\n             syndrome\r\n\r\n          -  No unwillingness to participate or inability to comply with the protocol for the\r\n             duration of the study\r\n\r\n        PRIOR CONCURRENT THERAPY:\r\n\r\n          -  No prior chemotherapy or radiotherapy for this tumor\r\n\r\n          -  No prior resection or attempted resection of esophageal cancer\r\n\r\n          -  No prior anti-epidermal growth factor receptor therapy (unless given in an adjuvant\r\n             setting and completed at least 12 months earlier)\r\n\r\n          -  No participation in any investigational drug study within the past 4 weeks\r\n\r\n          -  No HIV-positive patients receiving antiretroviral therapy\r\n\r\n          -  No concurrent CYP3A4/5 inducers or inhibitors\r\n      ","sponsor":"Roswell Park Cancer Institute","sponsor_type":"Other","conditions":"Esophageal Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: erlotinib hydrochloride","description":"Oral"},{"intervention_type":"Other","name":"Other: immunohistochemistry staining method","description":"Correlative Study"},{"intervention_type":"Radiation","name":"Radiation: radiation therapy","description":"Radiation Treatment"}],"outcomes":[{"outcome_type":"secondary","measure":"Response by Epidermal Growth Factor Receptor (EGFR) Expression","time_frame":"Radiologic evaluation every 3 months, up to 5 years"},{"outcome_type":"secondary","measure":"Response by Phosphor Epidermal Growth Factor Receptor (pEGFR) Expression","time_frame":"Radiologic evaluation every 3 months, up to 5 years"},{"outcome_type":"secondary","measure":"Response by EGFR Mutation Status","time_frame":"Radiologic evaluation every 3 months, up to 5 years"},{"outcome_type":"primary","measure":"Overall Survival","time_frame":"5 years"},{"outcome_type":"secondary","measure":"Complete Response","time_frame":"4-8 weeks after completion of radiation.","description":"Response assessment by CT scans and upper endoscopy performed between 4-8 weeks after completion of radiation.\r\nComplete Response (CR) is defined as absence of viable tumor in endoscopic evaluation post chemoradiation, with four-quadrant biopsies taken at 1 cm intervals throughout length of original tumor."},{"outcome_type":"secondary","measure":"Progresssion-Free Survival","time_frame":"Every 3 months, up to 5 years","description":"Progression is defined as at least a 20% increase in the sum of long distance of target lesions taking as reference the smallest sum long distance recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions."},{"outcome_type":"secondary","measure":"Effect of Study Therapy on Overall Quality of Life as Assessed by FACT-E Scale","time_frame":"Baseline and Week 3","description":"Functional Assessment of Cancer Therapy-Esophagus (FACT-E) is a health-related quality of life instrument validated in esophageal cancer patients. All of the scales and single-item measures range in score from 0 to 4. The ranges of average quality of life scores was from 0 to 4 and was adjusted as lower scores indicate better outcomes"},{"outcome_type":"secondary","measure":"Correlation of Smoking Status With Overall Survival","time_frame":"5 years"}]}
{"nct_id":"NCT00346359","start_date":"2006-03-31","phase":"Phase 2","enrollment":40,"brief_title":"Fludarabine and Busulfan Followed by Donor Peripheral Stem Cell Transplant and Antithymocyte Globulin, Tacrolimus, and Methotrexate in Treating Patients With Myeloid Cancer","official_title":"Conditioning For Hematopoietic Cell Transplantation With Fludarabine Plus Targeted IV Busulfan and GVHD Prophylaxis With Thymoglobulin, Tacrolimus and Methotrexate in Patients With Myeloid Malignancies","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-11-30","last_update":"2010-05-14","description":"RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor peripheral stem cell transplant helps stop the growth of abnormal and cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining abnormal or cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving antithymocyte globulin, tacrolimus, and methotrexate before or after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving fludarabine together with busulfan followed by donor peripheral stem cell transplant and antithymocyte globulin, tacrolimus, and methotrexate works in treating patients with myeloid cancer.","other_id":"2041.00","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","maximum_age":65,"population":"","criteria":"\n        DISEASE CHARACTERISTICS:\r\n\r\n          -  Diagnosis of 1 of the following myeloid malignancies:\r\n\r\n               -  Chronic myelogenous leukemia meeting 1 of the following criteria:\r\n\r\n                    -  Chronic phase\r\n\r\n                    -  Accelerated phase\r\n\r\n                    -  Treated blast phase\r\n\r\n               -  Acute myeloid leukemia meeting 1 of the following criteria:\r\n\r\n                    -  In remission\r\n\r\n                    -  In early relapse, defined as < 10% marrow blasts\r\n\r\n               -  Myelodysplastic syndromes, including all risk groups\r\n\r\n               -  Other myeloproliferative disorders\r\n\r\n          -  HLA-A, -B, -C, -DRB1, and -DQB1 matched related or unrelated donor available\r\n\r\n        PATIENT CHARACTERISTICS:\r\n\r\n          -  No other disease that would severely limit life expectancy\r\n\r\n          -  AST  2 times normal\r\n\r\n          -  Creatinine  2 times normal OR creatinine clearance  60 mL/min\r\n\r\n          -  No cardiac insufficiency requiring treatment\r\n\r\n          -  No symptomatic coronary artery disease\r\n\r\n          -  PO_2  70 mm Hg AND DLCO  70% of predicted OR PO _2  80 mm Hg AND DLCO  60% of\r\n             predicted\r\n\r\n          -  HIV negative\r\n\r\n          -  Not pregnant or nursing\r\n\r\n          -  Fertile patients must use effective contraception\r\n\r\n        PRIOR CONCURRENT THERAPY:\r\n\r\n          -  No post-transplantation growth factor during methotrexate administration\r\n      ","sponsor":"Fred Hutchinson Cancer Research Center","sponsor_type":"Other","conditions":"Chronic Myeloproliferative Disorders|Graft Versus Host Disease|Leukemia|Myelodysplastic Syndromes|Myelodysplastic/Myeloproliferative Diseases","interventions":[{"intervention_type":"Drug","name":"Drug: methotrexate"},{"intervention_type":"Drug","name":"Drug: tacrolimus"},{"intervention_type":"Biological","name":"Biological: anti-thymocyte globulin"},{"intervention_type":"Drug","name":"Drug: busulfan"},{"intervention_type":"Drug","name":"Drug: fludarabine phosphate"},{"intervention_type":"Procedure","name":"Procedure: allogeneic hematopoietic stem cell transplantation"},{"intervention_type":"Procedure","name":"Procedure: peripheral blood stem cell transplantation"}],"outcomes":[{"outcome_type":"primary","measure":"Incidence and severity of acute graft-versus-host disease (GVHD)"},{"outcome_type":"primary","measure":"Incidence of donor engraftment"},{"outcome_type":"secondary","measure":"Pharmacokinetics of IV busulfan including interdose variability and evaluation of a limited sampling strategy"},{"outcome_type":"secondary","measure":"Pharmacokinetics of antithymocyte globulin"},{"outcome_type":"secondary","measure":"Pharmacokinetics of fludarabine phosphate and its effect on lymphocytes"},{"outcome_type":"secondary","measure":"Incidence of specific toxic effects ≥ grade 3"},{"outcome_type":"secondary","measure":"Incidence and severity of chronic GVHD"},{"outcome_type":"secondary","measure":"Incidence of nonrelapsing mortality at 100 days and at 1 year after transplantation"},{"outcome_type":"secondary","measure":"Incidence of relapse"},{"outcome_type":"secondary","measure":"Relapse-free survival"},{"outcome_type":"secondary","measure":"Incidence of Epstein-Barr virus activation and post-transplantation lymphoproliferative disease"}]}
{"nct_id":"NCT00736086","start_date":"2006-03-31","enrollment":165,"brief_title":"RISE: A Clinical Evaluation of the StarClose Vascular Closure System","official_title":"A Post-Market, Prospective, Multi-Center, Study to Evaluate Safety and Efficacy of the StarClose Vascular Closure System in Patients Who Are Ambulated Early Post-Diagnostic Catheterization","primary_completion_date":"2006-11-30","study_type":"Observational","rec_status":"Completed","completion_date":"2006-12-31","last_update":"2008-08-15","description":"To evaluate early ambulation in patients who receive the StarClose VCS post-percutaneous diagnostic procedure.","other_id":"AVD-640-0057","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":85,"population":"Subjects who are ambulated early post-percutaneous, cardiac or peripheral vascular,\r\n        diagnostic catheterization procedure","criteria":"\n        Inclusion:\r\n\r\n          -  Subject must be 18-85.\r\n\r\n          -  Subject must be an acceptable candidate for an elective,non-emergent diagnostic\r\n             procedure performed percutaneously via the common femoral artery through either a 5F\r\n             or 6F procedural sheath.\r\n\r\n          -  Subject is an acceptable candidate for emergent vascular surgery.\r\n\r\n          -  Subject agrees to follow-up evaluations to assess for complications related to femoral\r\n             access site.\r\n\r\n          -  If among the 50 ultrasound sub-study Subjects enrolled,Subject agrees to have an\r\n             ultrasound of femoral artery performed post-procedure during the 30  7 days follow-up\r\n             visit.\r\n\r\n          -  Subject or legal representative has been informed of the nature of the study and\r\n             agrees to provisions and has provided written informed consent as approved by the\r\n             Institutional Review Board of respective clinical site.\r\n\r\n        Exclusion:\r\n\r\n          -  History of bleeding diathesis or coagulopathy including hemophilia, von Willebrand's\r\n             disease, and/or a current, known platelet count <100,000 cells/mm3, or baseline INR >\r\n             1.7.\r\n\r\n          -  Body Mass Index (BMI)  35 kg/m2.\r\n\r\n          -  Presence of significant anemia (Hgb < 10 g/dL, Hct < 30%).\r\n\r\n          -  Advanced Subject refusal of blood transfusions, should transfusion become necessary.\r\n\r\n          -  Participation in another trial of an investigational drug or device that has not yet\r\n             completed follow-up requirements.\r\n\r\n          -  Pregnant or lactating female.\r\n\r\n          -  Clinically severe peripheral vascular disease in the ipsilateral limb, defined as\r\n             severe claudication (walking < 100 feet), weak or absent pulses, or lower extremity\r\n             vascular graft.\r\n\r\n          -  History of ipsilateral femoral arterial puncture within previous three months or\r\n             history of vascular closure device deployment in ipsilateral femoral artery at any\r\n             time.\r\n\r\n          -  Subject has unilateral or bilateral lower extremity amputation(s).\r\n\r\n          -  Subject is unable to routinely walk at least 20 feet without assistance.\r\n\r\n          -  Subject has an active systemic or cutaneous infection or inflammation.\r\n\r\n          -  Subject has a pre-existing severe non-cardiac systemic disease or illness with a life\r\n             expectancy of < 30 days.\r\n\r\n          -  Subject has already participated in this Study.\r\n\r\n          -  Subject has known allergy to nitinol.\r\n\r\n        Access Site Exclusion-(*Evaluated via Limited Femoral Angiogram)\r\n\r\n          -  Pseudoaneurysm or AV fistula present in ipsilateral femoral artery prior to arterial\r\n             closure.*\r\n\r\n          -  Puncture distal to the common femoral artery bifurcation or above the inguinal\r\n             ligament which is typically defined by the inferior border of the inferior epigastric\r\n             artery on sheath angiogram or the upper third of the femoral head by plain\r\n             fluoroscopy.*\r\n\r\n          -  The arterial lumen diameter at the arteriotomy site is < 5mm by visual estimate.*\r\n\r\n          -  Angiographic evidence of calcified lesions at the arteriotomy site.*\r\n\r\n          -  Difficulty inserting the introducer sheath at the start of the catheterization\r\n             procedure due to vessel scarring or tortuosity, or anterior/posterior wall femoral\r\n             artery punctures or greater than 2 ipsilateral arterial puncture attempts at the time\r\n             of the percutaneous procedure.\r\n\r\n          -  Known iliac or femoral stenosis >50% or previous bypass surgery or stent placement in\r\n             the vicinity of the puncture site.\r\n\r\n          -  Planned percutaneous procedure (diagnostic or intervention) in ipsilateral femoral\r\n             artery prior to the 30-day follow-up evaluation.\r\n\r\n          -  Subject has intra-procedural bleeding around the access site.\r\n\r\n          -  Presence or previous use of an intra-aortic balloon pump through the existing arterial\r\n             puncture site.\r\n\r\n        Procedural Exclusion:\r\n\r\n          -  Low molecular weight heparin administration within 8 hours of enrollment.\r\n\r\n          -  For cases where anticoagulants are used, ACT level > 350 seconds at time of\r\n             enrollment.\r\n\r\n          -  Subject is determined to require treatment that will extend hospitalization (e.g.\r\n             ---Subject is undergoing CABG surgery or staged PTCA).\r\n\r\n          -  Persistent hypertension (SBP >180 or DBP >110 mm Hg) unresponsive to medical -therapy\r\n             at time of enrollment.\r\n\r\n          -  Placement of an ipsilateral femoral venous sheath during procedure.\r\n\r\n          -  Presence of clinically significant hematoma (> 6 cm) in ipsilateral femoral artery\r\n             prior to arterial closure.\r\n\r\n          -  Placement of introducer sheath < 5F or > 6F during procedure.\r\n      ","sponsor":"Abbott Medical Devices","sponsor_type":"Industry","conditions":"Peripheral Vascular Disease|Cardiovascular Disease","interventions":[{"intervention_type":"Device","name":"Device: Vessel Closure (StarClose)"}],"outcomes":{}}
{"nct_id":"NCT00306592","start_date":"2006-03-31","phase":"Phase 3","enrollment":404,"brief_title":"Natalizumab Re-Initiation of Dosing","official_title":"An Open-Label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801, C-1802, or C-1803 and a Dosing Suspension Safety Evaluation","primary_completion_date":"2007-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-02-29","last_update":"2017-03-21","description":"The primary objectives of this study are to further evaluate the safety of natalizumab (Tysabri) monotherapy by evaluating the risk of hypersensitivity and immunogenicity following re-exposure to natalizumab, and to confirm the safety of switching to natalizumab from interferon beta (IFN-), glatiramer acetate (GA), or other multiple sclerosis (MS) therapies.","other_id":"101-MS-322","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  MS subjects who completed Study C-1801 (NCT00027300), C-1802 (NCT00030966), or C-1803\r\n             (NCT00097760) and completed a Dosing Suspension Safety Evaluation (neurological\r\n             examination and magnetic resonance imaging [MRI] scan)\r\n\r\n          -  Considered by the investigator to be free of signs and symptoms suggestive of\r\n             progressive multifocal leukoencephalopathy (PML) based on medical history, physical\r\n             examination, or laboratory testing (results from the Dosing Suspension Safety\r\n             Evaluation from Study C-1808 [NCT000276172] may be used)\r\n\r\n          -  Other protocol-defined inclusion criteria may apply\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Considered by the investigator to be immunocompromised, based on medical history,\r\n             physical examination, or laboratory testing (results from the Dosing Suspension Safety\r\n             Evaluation from Study C-1808 may be used), or due to prior immunosuppressive treatment\r\n\r\n          -  History of persistent anti-natalizumab antibodies, based upon testing from prior\r\n             natalizumab studies\r\n\r\n          -  Other protocol-defined exclusion criteria may apply\r\n      ","sponsor":"Biogen","sponsor_type":"Industry","conditions":"Multiple Sclerosis, Relapsing-Remitting","interventions":[{"intervention_type":"Biological","name":"Biological: BG00002 (natalizumab)"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious AEs (SAEs)","time_frame":"Baseline through Week 48","description":"AEs: any sign, symptom, or diagnosis/disease that is unfavorable or unintended, that is new, or if pre-existing, worsens in participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. SAEs: an event that results in death; an event that, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); an outcome that results in a congenital anomaly/birth defect diagnosed in a child of a participant; an event that requires or prolongs inpatient hospitalization; an event that results in persistent or significant disability/incapacity. Any other medically important event that, in the opinion of the investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. Treatment-emergent AEs: events in participants who had received at least 1 dose of study drug, regardless of relationship to study drug."},{"outcome_type":"primary","measure":"Number of Participants With Hypersensitivity-related Adverse Events","time_frame":"Baseline through Week 48","description":"For purposes of this analysis, the terms 'hypersensitivity' and 'drug hypersensitivity' were categorized by their temporal relationship to study drug infusion (within 2 hours of the start of the infusion), and were considered equivalent. Hypersensitivity reactions are defined as infusion reactions with the following preferred terms: hypersensitivity not otherwise specified (NOS), anaphylactic reaction, anaphylactoid reaction, dermatitis allergic, drug hypersensitivity, urticaria NOS, vasoconstriction, urticaria generalised, hypersensitivity, urticaria."},{"outcome_type":"primary","measure":"Number of Participants With Antibodies to Natalizumab","time_frame":"Baseline (Week 0), Week 4, Week 24 (test was repeated after 8 weeks if positive, to confirm persistence)","description":"'Positive with unknown persistence' is defined as a positive result (≥0.5 micrograms/mL) at one timepoint only with no confirmatory re-test available at least 42 days later. 'Transient positive' is defined as a positive at one timepoint but negative upon re-test at least 42 days later. 'Persistent positive' is defined as positive at 2 or more timepoints separated by at least 42 days. The threshold for classifying a sample as 'antibody positive' was set at the lowest level of reactivity that had a measurable impact on drug serum concentrations."}]}
{"nct_id":"NCT00297752","start_date":"2006-03-31","phase":"Phase 4","enrollment":154,"brief_title":"Treatment of Facial Burns With Flammacerium Compared to Flammazine and the Impact of Facial Burns on Psychosocial Wellbeing","official_title":"A Randomised Multicentre Clinical Trial on the Efficacy of Flammacerium in the Treatment of Facial Burns and the Impact of Facial Burns on Psychosocial Wellbeing","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-12-31","last_update":"2020-02-17","description":"The face is involved in 40-50% of patients with burns admitted to the Dutch Burn Centres. Scarring of the face as a consequence of burns will often have a detrimental effect on function and aesthetics, and may cause negative effects on psychosocial wellbeing. What the best treatment is for facial burns, minimising scarring, is unclear. Besides that, there is little empirical evidence regarding the impact of facial scarring on psychosocial wellbeing. In clinical practice good results are felt to be achieved by treatment of facial burns with flammacerium. To substantiate the perceived advantages of flammacerium, its efficacy is compared to flammazine, a current alternative of care. The efficacy of treatment will be assessed in a prospective randomised multicentre clinical trial. Efficacy will be analysed in terms of number of patients requiring surgery and functional and aesthetic outcome. Apart from medical outcome, this study offers the opportunity to study psychosocial problems associated with facial defects. It is still an unresolved question whether facial scarring causes more or different psychosocial problems. Therefore, self-esteem and quality of life will be examined over time, in relation to depression, posttraumatic stress symptoms and other factors, such as coping style and social support. By evaluating the efficacy of different treatment strategies, we aim to optimise the standard of care of facial burns. Furthermore, this study wants to shed more light on the psychosocial impact of facial injury. With these results psychosocial professionals will be able to focus on persons at risk and to be better able to meet a patient's personal needs.","other_id":"WO/PO.109","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  patients of 18 years of age or older, competent or temporarily incompetent, who are\r\n             admitted to one of the three dedicated Dutch Burn Centres with burn injuries involving\r\n             the face\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  patients not seen within 24 hours postburn\r\n\r\n          -  patients with mental or cognitive deficits that may interfere with providing informed\r\n             consent\r\n\r\n          -  patients with poor Dutch proficiency\r\n\r\n          -  patients with chemical burns\r\n      ","sponsor":"Association of Dutch Burn Centres","sponsor_type":"Other","conditions":"Burns","interventions":[{"intervention_type":"Drug","name":"Drug: ceriumnitrate silversulfadiazine (flammacerium)","description":"treatment of patients with facial burns with CE-SSD"},{"intervention_type":"Drug","name":"Drug: silversulfadiazine (flammazine)","description":"treatment of patients with facial burns with SSD"}],"outcomes":[{"outcome_type":"primary","measure":"Regarding the efficacy of treatment","time_frame":"3 weeks","description":"time to wound healing"},{"outcome_type":"primary","measure":"* number of patients requiring surgical excision of their facial burns","time_frame":"6 weeks","description":"number of patients requiring surgical treatment for healing of facial burns"},{"outcome_type":"primary","measure":"Regarding psychosocial impact:","time_frame":"3 months","description":"discrepancy between patient and observer scar assessment"},{"outcome_type":"primary","measure":"* quality of life and self esteem","time_frame":"6 months post burn","description":"measurement of self esteem related to scar quality"},{"outcome_type":"secondary","measure":"● quality of scar (patient and observer)","time_frame":"12 months post burn","description":"scar assessment by patient and observer scar scale"},{"outcome_type":"secondary","measure":"● scar elasticity, vascularisation and pigmentation,","time_frame":"12 months post burn","description":"scar assessment by cutometer and dermaspectrometer"},{"outcome_type":"secondary","measure":"● hypertrophic surface area","time_frame":"12 months post burn","description":"scar thickness area"},{"outcome_type":"secondary","measure":"● functional and/or anatomic impairments,","time_frame":"12 months post burn","description":"descriptive analysis"},{"outcome_type":"secondary","measure":"● mimic function","time_frame":"12 months post burn","description":"physical examination"}]}
{"nct_id":"NCT00286494","start_date":"2006-02-28","phase":"Phase 3","enrollment":493,"brief_title":"Study of Alogliptin Combined With Pioglitazone in Subjects With Type 2 Diabetes Mellitus","official_title":"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of SYR110322 (SYR-322) When Used in Combination With Pioglitazone in Subjects With Type 2 Diabetes Mellitus","primary_completion_date":"2007-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-08-31","last_update":"2012-02-03","description":"The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), combined with pioglitazone in adults with type 2 diabetes mellitus","other_id":"SYR-322-TZD-009","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria\r\n\r\n          -  Diagnosis of type 2 diabetes mellitus currently treated with a thiazolidinedione\r\n             either alone or in combination with metformin or a sulfonylurea but who are\r\n             experiencing inadequate glycemic control. The subject should have received the\r\n             thiazolidinedione therapy (rosiglitazone or pioglitazone) either alone or in\r\n             combination with metformin or a sulfonylurea for at least the 3 months prior to\r\n             Screening and must have been on a stable dose for all their antidiabetic treatments\r\n             for at least the month prior to Screening.\r\n\r\n          -  No treatment with antidiabetic agents other than a thiazolidinedione alone or in\r\n             combination with either metformin or a sulfonylurea within the 3 months prior to\r\n             Screening. (Exception: if a subject has received other antidiabetic therapy for less\r\n             than 7 days within the 3 months prior to Screening.)\r\n\r\n          -  Body mass index greater than or equal to 23 kg/m2 and less than or equal to 45 kg/m2\r\n\r\n          -  Fasting C-peptide concentration greater than or equal to 0.8 ng per mL. (If this\r\n             screening criterion is not met, the subject still qualifies if C-peptide is greater\r\n             than or equal to 1.5 ng per mL after a challenge test.)\r\n\r\n          -  Glycosylated hemoglobin concentration between 7.0% and 10.0%, inclusive.\r\n\r\n          -  If regular use of other, non-excluded medications, must be on a stable dose for at\r\n             least the 4 weeks prior to Screening. However, as needed use of prescription or\r\n             over-the-counter medications is allowed at the discretion of the investigator.\r\n\r\n          -  Systolic blood pressure less than or equal to 180 mm Hg and diastolic pressure less\r\n             than or equal to 110 mm Hg.\r\n\r\n          -  Hemoglobin greater than or equal to 12 g per dL for males and greater than or equal\r\n             to10 g per dL for females.\r\n\r\n          -  Alanine aminotransferase less than or equal to 2.5 times the upper limit of normal.\r\n\r\n          -  Serum creatinine less than or equal to 2.0 mg per dL.\r\n\r\n          -  Thyroid-stimulating hormone level less than or equal to the upper limit of the normal\r\n             range and the subject is clinically euthyroid.\r\n\r\n          -  Neither pregnant nor lactating.\r\n\r\n          -  Female subjects of childbearing potential must be practicing adequate contraception.\r\n             Adequate contraception must be practiced for the duration of participation in the\r\n             study.\r\n\r\n          -  Able and willing to monitor their own blood glucose concentrations with a home glucose\r\n             monitor.\r\n\r\n          -  No major illness or debility that in the investigator's opinion prohibits the subject\r\n             from completing the study.\r\n\r\n          -  Able and willing to provide written informed consent.\r\n\r\n        Exclusion Criteria\r\n\r\n          -  Urine albumin to creatinine ratio of greater than 1000 g per mg at Screening. If\r\n             elevated, the subject may be rescreened within 1 week.\r\n\r\n          -  History of cancer, other than squamous cell or basal cell carcinoma of the skin, that\r\n             has not been in full remission for at least 5 years prior to Screening. (A history of\r\n             treated cervical intraepithelial neoplasia I or cervical intraepithelial neoplasia II\r\n             is allowed.)\r\n\r\n          -  History of laser treatment for proliferative diabetic retinopathy within the 6 months\r\n             prior to Screening.\r\n\r\n          -  History of treated diabetic gastric paresis.\r\n\r\n          -  New York Heart Association Class III or IV heart failure regardless of therapy.\r\n             Currently treated subjects who are stable at Class I or II are candidates for the\r\n             study.\r\n\r\n          -  History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or\r\n             myocardial infarction within the 6 months prior to Screening\r\n\r\n          -  History of any hemoglobinopathy that may affect determination of glycosylated\r\n             hemoglobin.\r\n\r\n          -  History of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.\r\n\r\n          -  History of a psychiatric disorder that will affect the subject's ability to\r\n             participate in the study.\r\n\r\n          -  History of angioedema in association with use of angiotensin-converting enzyme\r\n             inhibitors or angiotensin-II receptor inhibitors.\r\n\r\n          -  History of alcohol or substance abuse within the 2 years prior to Screening.\r\n\r\n          -  Receipt of any investigational drug within the 30 days prior to Screening or a history\r\n             of receipt of an investigational antidiabetic drug within the 3 months prior to\r\n             Screening.\r\n\r\n          -  Prior treatment in an investigational study of alogliptin.\r\n\r\n          -  Excluded Medications:\r\n\r\n               -  Treatment with antidiabetic agents other than a thiazolidinedione alone or in\r\n                  combination with either metformin or a sulfonylurea is not allowed within the 3\r\n                  months prior to Screening and through the completion of the\r\n                  end-of-treatment/early termination procedures.\r\n\r\n               -  Treatment with weight-loss drugs, any investigational antidiabetics, or oral or\r\n                  systemically injected glucocorticoids is not allowed from 3 months prior to\r\n                  randomization through the completion of the end-of-treatment/early termination\r\n                  procedures. Inhaled corticosteroids are allowed.\r\n\r\n        Subjects must not take any medications, including over-the-counter products, without first\r\n        consulting with the investigator.\r\n      ","sponsor":"Takeda","sponsor_type":"Industry","conditions":"Diabetes Mellitus","interventions":[{"intervention_type":"Drug","name":"Drug: Alogliptin and pioglitazone","description":"Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks"},{"intervention_type":"Drug","name":"Drug: Alogliptin and pioglitazone","description":"Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks"},{"intervention_type":"Drug","name":"Drug: Pioglitazone","description":"Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks"}],"outcomes":[{"outcome_type":"secondary","measure":"Change From Baseline in Fasting Plasma Glucose (Week 4).","time_frame":"Baseline and Week 4.","description":"The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline."},{"outcome_type":"primary","measure":"Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.","time_frame":"Baseline and Week 26.","description":"The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 26 or final visit and glycosylated hemoglobin collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Glycosylated Hemoglobin (Week 4).","time_frame":"Baseline and Week 4.","description":"The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and Glycosylated Hemoglobin collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Glycosylated Hemoglobin (Week 8).","time_frame":"Baseline and Week 8.","description":"The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and Glycosylated Hemoglobin collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Glycosylated Hemoglobin (Week 12).","time_frame":"Baseline and Week 12.","description":"The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and Glycosylated Hemoglobin collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Glycosylated Hemoglobin (Week 16).","time_frame":"Baseline and Week 16.","description":"The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and Glycosylated Hemoglobin collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Glycosylated Hemoglobin (Week 20).","time_frame":"Baseline and Week 20.","description":"The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and Glycosylated Hemoglobin collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Fasting Plasma Glucose (Week 1).","time_frame":"Baseline and Week 1.","description":"The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Fasting Plasma Glucose (Week 2).","time_frame":"Baseline and Week 2.","description":"The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Fasting Plasma Glucose (Week 8).","time_frame":"Baseline and Week 8.","description":"The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Fasting Plasma Glucose (Week 12).","time_frame":"Baseline and Week 12.","description":"The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Fasting Plasma Glucose (Week 16).","time_frame":"Baseline and Week 16.","description":"The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Fasting Plasma Glucose (Week 20).","time_frame":"Baseline and Week 20.","description":"The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Fasting Plasma Glucose (Week 26).","time_frame":"Baseline and Week 26.","description":"The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline."},{"outcome_type":"secondary","measure":"Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).","time_frame":"26 Weeks.","description":"The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during the 26 week study."},{"outcome_type":"secondary","measure":"Number of Participants Requiring Rescue.","time_frame":"26 Weeks.","description":"The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study."},{"outcome_type":"secondary","measure":"Change From Baseline in Fasting Proinsulin (Week 4).","time_frame":"Baseline and Week 4.","description":"The change between the value of fasting proinsulin collected at week 4 and fasting proinsulin collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Fasting Proinsulin (Week 8).","time_frame":"Baseline and Week 8.","description":"The change between the value of fasting proinsulin collected at week 8 and fasting proinsulin collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Fasting Proinsulin (Week 12).","time_frame":"Baseline and Week 12.","description":"The change between the value of fasting proinsulin collected at week 12 and fasting proinsulin collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Fasting Proinsulin (Week 16).","time_frame":"Baseline and Week 16.","description":"The change between the value of fasting proinsulin collected at week 16 and fasting proinsulin collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Fasting Proinsulin (Week 20).","time_frame":"Baseline and Week 20.","description":"The change between the value of fasting proinsulin collected at week 20 and fasting proinsulin collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Fasting Proinsulin (Week 26).","time_frame":"Baseline and Week 26.","description":"The change between the value of fasting proinsulin collected at week 26 or final visit and fasting proinsulin collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Insulin (Week 4).","time_frame":"Baseline and Week 4.","description":"The change between the value of insulin collected at week 4 and insulin collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Insulin (Week 8).","time_frame":"Baseline and Week 8.","description":"The change between the value of insulin collected at week 8 and insulin collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Insulin (Week 12).","time_frame":"Baseline and Week 12.","description":"The change between the value of insulin collected at week 12 and insulin collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Insulin (Week 16).","time_frame":"Baseline and Week 16.","description":"The change between the value of insulin collected at week 16 and insulin collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Insulin (Week 20).","time_frame":"Baseline and Week 20.","description":"The change between the value of insulin collected at week 20 and insulin collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Insulin (Week 26).","time_frame":"Baseline and Week 26.","description":"The change between the value of insulin collected at week 26 and insulin collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Proinsulin/Insulin Ratio (Week 4).","time_frame":"Baseline and Week 4.","description":"The change between the ratio value of proinsulin and insulin collected at week 4 and the ratio value of proinsulin and insulin collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Proinsulin/Insulin Ratio (Week 8).","time_frame":"Baseline and Week 8.","description":"The change between the ratio value of proinsulin and insulin collected at week 8 and the ratio value of proinsulin and insulin collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Proinsulin/Insulin Ratio (Week 12).","time_frame":"Baseline and Week 12.","description":"The change between the ratio value of proinsulin and insulin collected at week 12 and the ratio value of proinsulin and insulin collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Proinsulin/Insulin Ratio (Week 16).","time_frame":"Baseline and Week 16.","description":"The change between the ratio value of proinsulin and insulin collected at week 16 and the ratio value of proinsulin and insulin collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Proinsulin/Insulin Ratio (Week 20).","time_frame":"Baseline and Week 20.","description":"The change between the ratio value of proinsulin and insulin collected at week 20 and the ratio value of proinsulin and insulin collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Proinsulin/Insulin Ratio (Week 26).","time_frame":"Baseline and Week 26.","description":"The change between the ratio value of proinsulin and insulin collected at week 26 or final visit and the ratio value of proinsulin and insulin collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in C-peptide (Week 4).","time_frame":"Baseline and Week 4.","description":"The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in C-peptide (Week 8).","time_frame":"Baseline and Week 8.","description":"The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in C-peptide (Week 12).","time_frame":"Baseline and Week 12.","description":"The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in C-peptide (Week 16).","time_frame":"Baseline and Week 16.","description":"The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in C-peptide (Week 20).","time_frame":"Baseline and Week 20.","description":"The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in C-peptide (Week 26).","time_frame":"Baseline and Week 26.","description":"The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline."},{"outcome_type":"secondary","measure":"Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.","time_frame":"Baseline and Week 26.","description":"The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5% during the 26 week study."},{"outcome_type":"secondary","measure":"Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.","time_frame":"Baseline and Week 26.","description":"The number of participants with a value for the percentage of glycosylated hemoglobin less (the percentage of hemoglobin that is bound to glucose) than or equal to 7.0% during the 26 week study."},{"outcome_type":"secondary","measure":"Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.","time_frame":"Baseline and Week 26.","description":"The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.5% during the 26 week study."},{"outcome_type":"secondary","measure":"Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.","time_frame":"Baseline and Week 26.","description":"The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5% during the 26 week study."},{"outcome_type":"secondary","measure":"Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.","time_frame":"Baseline and Week 26.","description":"The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.0% during the 26 week study."},{"outcome_type":"secondary","measure":"Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.","time_frame":"Baseline and Week 26.","description":"The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.5% during the 26 week study."},{"outcome_type":"secondary","measure":"Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.","time_frame":"Baseline and Week 26.","description":"The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 2.0% during the 26 week study."},{"outcome_type":"secondary","measure":"Change From Baseline in Body Weight (Week 8).","time_frame":"Baseline and Week 8.","description":"The change between Body Weight measured at week 8 and Body Weight measured at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Body Weight (Week 12).","time_frame":"Baseline and Week 12.","description":"The change between Body Weight measured at week 12 and Body Weight measured at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Body Weight (Week 20).","time_frame":"Baseline and Week 20.","description":"The change between Body Weight measured at week 20 and Body Weight measured at baseline."},{"outcome_type":"secondary","measure":"Change From Baseline in Body Weight (Week 26).","time_frame":"Baseline and Week 26.","description":"The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline."}]}
{"nct_id":"NCT00517621","start_date":"2006-02-28","phase":"Phase 2","enrollment":100,"brief_title":"Use of FACT-GOG/NTX Questionnaire in Peripheral Neurotoxicity & Validation of a French Version of This Questionnaire","official_title":"A Multicenter Prospective Phase II Study Evaluating Peripheral Neurotoxicity by Using FACT-GOG/NTX Questionnaire in Patients With Ovarian Cancer in Relapse Treated by Paclitaxel +/- EPO. Validation of a French Version of This Questionnaire","primary_completion_date":"2010-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-10-31","last_update":"2011-02-25","description":"validation of a french version of FACT-GOG/NTX and using this questionnaire to evaluate the incidence of the peripheral neurotoxicity in patients treated for ovarian cancer with paclitaxel associated or not with EPO.","other_id":"ETAMINE","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Femal patient aged > 18 years\r\n\r\n          -  Histologically proven diagnosis of cancer of the ovary, the fallopian tube or\r\n             peritoneal\r\n\r\n          -  patients whose disease progresses or relapses\r\n\r\n          -  patients having received at least a line of platinum-based chemotherapy\r\n\r\n          -  patients whose treatment of relapse is envisaged to comprise paclitaxel\r\n\r\n          -  patients who will receive EPO for treatment of their anaemia\r\n\r\n          -  ECOG performans status < 2\r\n\r\n          -  life expectancy > 16 weeks\r\n\r\n          -  patient who has clearly given her consent by signing on informed consent form prior to\r\n             participation\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  peripheral neuropathy grade > 2\r\n\r\n          -  history of ischemic cardiopathy, congestive heart failure (NYHA>2), arrhythmia,\r\n             hypertension or significant valvulopathy\r\n\r\n          -  abnormal biological values\r\n\r\n          -  A therapy or a serious disease which could involve a risk for the patient or interfere\r\n             with the aims of the study\r\n\r\n          -  patient who is pregnant, breast feeding or using inadequate contraception\r\n\r\n          -  concomitant therapy by a potentially neurotoxic drug\r\n\r\n          -  concomitant inclusion in another therapeutic trial which could interfere with the aims\r\n             of the study\r\n\r\n          -  patient who for familial, sociological, geographical or psychological condition could\r\n             not be followed correctly\r\n      ","sponsor":"ARCAGY/ GINECO GROUP","sponsor_type":"Other","conditions":"Ovarian Cancer|Fallopian Tube Cancer|Peritoneal Neoplasms","interventions":[{"intervention_type":"Drug","name":"Drug: Paclitaxel"},{"intervention_type":"Drug","name":"Drug: EPO"}],"outcomes":[{"outcome_type":"primary","measure":"Validation of a french version of FACT-GOG/NTX of peripheral neurotoxicity questionnaire"},{"outcome_type":"secondary","measure":"- incidence and severity of the peripheral neurotoxicity according to whether the patients are treated or not by EPO"},{"outcome_type":"secondary","measure":"- variation of the rate of haemoglobin during chemotherapy"},{"outcome_type":"secondary","measure":"- Incidence of the thrombo-embolic events according to whether the patients are treated or not by EPO"}]}
{"nct_id":"NCT00569569","start_date":"2006-02-28","phase":"Phase 2/Phase 3","enrollment":20,"brief_title":"Retaane in Age-Related Macular Degeneration","official_title":"Retaane in Age-Related Macular Degeneration","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-03-31","last_update":"2007-12-07","description":"The treatment of fibrotic choroidal neovascular lesions with presence of residual peripheral activity in age related macular degeneration currently presents a great challenge. With visual loss threatening, there are only very few therapeutic options. While these patients are neither suitable for laser therapy nor for photodynamic therapy with Verteporfin, antiangiogenic drugs applied intravitreally are now available. Some patients however reject this therapeutic option because of potential complications such as endophthalmitis and the frequency of necessary injections. 20 patients who rejected intravitreal therapy were treated with Anecortave acetate (Retaane) which was applied as a juxtascleral depot injection.","other_id":"RFC012007","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":90,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  rejection of intravitreal injections\r\n\r\n          -  presence of fibrotic choroidal neovascular lesions with presence of residual\r\n             peripheral activity in age related macular degeneration\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  conditions precluding judgement of the fundus\r\n      ","sponsor":"Rudolf Foundation Clinic","sponsor_type":"Other","conditions":"Age Related Macular Degeneration","interventions":[{"intervention_type":"Drug","name":"Drug: juxtascleral depot injection of Retaane","description":"juxtascleral depot injection of Retaane"}],"outcomes":[{"outcome_type":"primary","measure":"Increase in VA","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Decrease in Macula Edema","time_frame":"6 months"}]}
{"nct_id":"NCT00283049","start_date":"2006-02-28","phase":"Phase 4","enrollment":390,"brief_title":"Insulin Glargine Injection Treatment in Place of Thiazolidinedione (TZD), Sulfonylurea, or Metformin in Triple Agent Therapy for Type 2 Diabetes Mellitus (T2DM) Adult Subjects With Unsatisfactory Control","official_title":"Safety and Efficacy of Insulin Glargine Injection [rDNA Origin] Treatment in Place of the TZD or the Sulfonylurea or Metformin in Triple Agent Therapy for T2DM Adult Subjects With Unsatisfactory Control","primary_completion_date":"2008-11-30","study_type":"Interventional","rec_status":"Terminated","completion_date":"2008-11-30","last_update":"2011-01-13","description":"The purpose of this study is to compare the change in hemoglobin A1c (HbA1c) from baseline to Week 12 between the 3 treatment arms.","other_id":"HOE901_4052","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":79,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Subjects meeting all of the following criteria will be considered for enrollment into the\r\n        study:\r\n\r\n          1. 18 to 79 years of age, inclusive\r\n\r\n          2. Diagnosis of type 2 diabetes mellitus\r\n\r\n          3. Continuous treatment with therapeutic dosages of a thiazolidinedione (rosiglitazone or\r\n             pioglitazone), metformin, and a sulfonylurea daily prior to entering the study\r\n\r\n          4. Screening HbA1c  7.0%\r\n\r\n          5. Fasting C-peptide concentration  0.27 ng/ml\r\n\r\n          6. Negative glutamic acid decarboxylase (GAD) antibodies\r\n\r\n          7. Demonstrated ability and willingness to perform self-monitoring blood glucose (SMBG)\r\n             using a plasma-referenced glucose meter and to maintain an electronic diary\r\n\r\n          8. Demonstrated ability and willingness to use an electronic diary to record SMBG\r\n             results, insulin doses, and hypoglycemic events.\r\n\r\n          9. Signed, informed consent and Health Insurance Portability and Accountability Act\r\n             (HIPAA) documentation\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Stroke, myocardial infarction, coronary artery bypass graft, percutaneous transluminal\r\n             coronary angioplasty, or angina pectoris, within the last 12 months\r\n\r\n          2. Cardiac status New York Heart Association (NYHA) III-IV\r\n\r\n          3. Impaired renal function as shown by, but not limited to, serum creatinine  1.5 mg/dL\r\n             for males, or  1.4 mg/dL for females\r\n\r\n          4. Chronic use of insulin: (more than 3 weeks of continuous use) in the past 12 months\r\n\r\n          5. Acute infection\r\n\r\n          6. Clinically significant peripheral edema\r\n\r\n          7. Acute or chronic history of metabolic acidosis, including diabetic ketoacidosis\r\n\r\n          8. Clinical evidence of active liver disease, or serum alanine aminotransferase (ALT) or\r\n             aspartate aminotransferase (AST) 2.5 times the upper limit of the normal range\r\n\r\n          9. History of hypoglycemia unawareness\r\n\r\n         10. Pregnancy or lactation\r\n\r\n         11. Known hypersensitivity to insulin glargine or any of the components of Lantus\r\n\r\n         12. Known hypersensitivity to insulin glulisine or any of the components of Apidra\r\n\r\n         13. Any malignancy within the last 5 years, with the exception of adequately treated basal\r\n             or squamous cell carcinoma of the skin or adequately treated cervical carcinoma in\r\n             situ\r\n\r\n         14. Current addiction or current alcohol abuse, or history of substance or alcohol abuse\r\n             within the last 2 years\r\n\r\n         15. Diagnosis of dementia\r\n\r\n         16. Subject is the investigator or any sub-investigator, research assistant, pharmacist,\r\n             study coordinator, other staff or relative thereof directly involved in the conduct of\r\n             the protocol\r\n\r\n         17. Mental condition rendering the subject unable to understand the nature, scope, and\r\n             possible consequences of the study. Subject unlikely to comply with protocol, e.g.,\r\n             uncooperative attitude, inability to return for follow-up visits, and unlikelihood of\r\n             completing the study\r\n\r\n         18. subject is currently taking or was treated with the following medications 3 months\r\n             prior to screening: Byetta(exenatide), Starlix(nateglinide),Prandin (repaglinide),\r\n             Januvia(sitagliptin), Janumet(metformin + sitagliptin)\r\n\r\n         19. Any disease or condition that in the opinion of the investigator and/or sponsor may\r\n             interfere with the completion of the study\r\n      ","sponsor":"Sanofi","sponsor_type":"Industry","conditions":"Diabetes Mellitus, Type 2","interventions":[{"intervention_type":"Drug","name":"Drug: Insulin Glargine","description":"Insulin glargine administered subcutaneously once daily."},{"intervention_type":"Drug","name":"Drug: Insulin Glulisine","description":"Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)"}],"outcomes":[{"outcome_type":"primary","measure":"Change in Hemoglobin A1c (HbA1c) From Baseline to Week 12","time_frame":"12 weeks from Baseline"},{"outcome_type":"secondary","measure":"Change From Baseline to Individual Time Points in HbA1c, Insulin Doses, and Total Insulin Dosage","time_frame":"60 weeks from Baseline"},{"outcome_type":"secondary","measure":"Percentage of Subjects Achieving an HbA1C Less Than (<) 7.0% and Less Than (<) 6.5%","time_frame":"60 weeks from Baseline"},{"outcome_type":"secondary","measure":"Change From Baseline to Study Time Points in 7-point Blood Glucose (BG) Profile (Before Meals, 2 Hours After Meals, at Bedtime)","time_frame":"60 weeks from Baseline"},{"outcome_type":"secondary","measure":"Change From Baseline to End of Study and to Individual Time Points in Components of Lipid Profile (Total Cholesterol, High-density Lipoprotein Cholesterol [HDL], Low-density Lipoprotein Cholesterol [LDL], Triglycerides, LDL Subfractions)","time_frame":"60 weeks from Baseline"},{"outcome_type":"secondary","measure":"Occurrences of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia, and Serious Hypoglycemia","time_frame":"60 weeks from Baseline","description":"Symptomatic hypoglycemia (BG<70 mg/dL, BG<50 mg/dL): including 1 or more symptoms: headache, dizziness, general feeling of weakness, drowsiness, confusion, pallor, irritability, trembling, sweating, rapid heartbeat & a cold, clammy feeling.\r\nMild-to-moderate hypoglycemia: SMBG ≥ 36 mg/dL but <70 mg/dL\r\nSevere hypoglycemia: assistance of another party is required & either:\r\nSMBG of <36 mg/dL, or\r\nwith prompt response to treatment with oral carbohydrates, IV glucose or glucagon.\r\nSerious hypoglycemia:\r\nHypoglycemia with coma/loss of consciousness Or Hypoglycemia seizure/convulsion."},{"outcome_type":"secondary","measure":"Rate of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia and Serious Hypoglycemia","time_frame":"60 Weeks from Baseline","description":"Symptomatic hypoglycemia (BG<70 mg/dL, BG<50 mg/dL): including 1 or more symptoms: headache, dizziness, general feeling of weakness, drowsiness, confusion, pallor, irritability, trembling, sweating, rapid heartbeat & a cold, clammy feeling.\r\nMild-to-moderate hypoglycemia: SMBG ≥ 36 mg/dL but <70 mg/dL\r\nSevere hypoglycemia: assistance of another party is required & either:\r\nSMBG of <36 mg/dL, or\r\nwith prompt response to treatment with oral carbohydrates, IV glucose or glucagon.\r\nSerious hypoglycemia:\r\nHypoglycemia with coma/loss of consciousness Or Hypoglycemia seizure/convulsion."}]}
{"nct_id":"NCT02691637","start_date":"2006-02-28","enrollment":1500,"brief_title":"Effect of H. Pylori Eradication on the Reversibility of Atrophic Gastritis and Intestinal Metaplasia in Korean Patients","official_title":"Effect of Helicobacter Pylori Eradication on the Reversibility of Atrophic Gastritis and Intestinal Metaplasia in Korean Patients.","primary_completion_date":"2022-12-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2022-12-31","last_update":"2021-03-23","description":"Helicobacter pylori (H. pylori) infection has been associated with a development of atrophic gastritis and intestinal metaplasia. H. pylori related atrophic gastritis and intestinal metaplasia have been regarded as pre-malignant lesion. However, the role of H. pylori eradication treatment in the reversibility of atrophic gastritis and intestinal metaplasia has not been clearly defined. The aim of the present study was to investigate the relationship between H. pylori eradication and the reversibility of atrophic gastritis and intestinal metaplasia in Korean patients.","other_id":"B-0602/030-001","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"Patients who have H. pylori related gastrointestinal disease and/or Patients who do not\r\n        have H. pylori related gastrointestinal disease. But, want H. pylori eradication","criteria":"\n        Inclusion Criteria:\r\n\r\n        - Patients who diagnosis of H. pylori infection\r\n\r\n          -  Patients presenting with H. pylori related gastrointestinal disease and/or\r\n\r\n          -  Patients do not have H. pylori related gastrointestinal disease. But, want H. pylori\r\n             eradication\r\n\r\n        Exclusion Criteria:\r\n\r\n        - Age under 18 years Previous eradication treatment for H. pylori Patients who took any\r\n        drug which could influence the study results such as proton pump inhibitor, antibiotics\r\n        within 4 weeks History of gastrectomy Advanced gastric cancer or other malignancy Abnormal\r\n        liver function or liver cirrhosis Abnormal renal function or chronic kidney disease Other\r\n        severe concurrent diseases Previous allergic reactions to the study drugs Pregnant or\r\n        lactating women\r\n      ","sponsor":"Seoul National University Bundang Hospital","sponsor_type":"Other","conditions":"Helicobacter Pylori Infection|Atrophic Gastritis|Intestinal Metaplasia","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"The improvement of Atrophic Gastritis and Intestinal metaplasia score","time_frame":"per 1 year","description":"The improvement of Atrophic Gastritis and Intestinal metaplasia was defined as improvement of score compared with baseline.\r\nThe histological features of the gastric mucosa were recorded using updated Sydney system scores, that is, 0 = none, 1 = mild, 2 = moderate, and 3 = marked.(Am J Surg Pathol 1996;20:1161-81.) Outcome measure will be done annually (per 1 year), final follow-up is 2019"}]}
{"nct_id":"NCT00707902","start_date":"2006-02-28","phase":"Phase 3","enrollment":154,"brief_title":"Clinical Trial for Assessment of Safety and Efficacy of a Echinacea/Sage Spray Compared to a Chlorhexidine/Lidocaine Spray in the Treatment of Acute Sore Throats","official_title":"Multicentric Randomized Double Blind Double Dummy Placebo Controlled Clinical Trial for Assessment of Safety and Efficacy of a Echinacea/Sage Spray in Comparison to a Chlorhexidine/Lidocaine Spray in the Treatment of Acute Sore Throats","study_type":"Interventional","rec_status":"Completed","completion_date":"2006-08-31","last_update":"2008-07-01","description":"The aim of the study is to show non-inferiority of an echinacea/sage spray compared to a chlorhexidine/lidocaine-spray in the treatment of acute sore throat during five days of treatment. Main outcome parameter is the non-inferiority in number of responders between the two treatment groups. A responder is defined as a reduction by 50% of the total baseline score taken prior to treatment start. The symptoms are assessed with a symptom score.","other_id":"920'073","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":12,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age > 12 years;\r\n\r\n          -  Acute pharyngitis or tonsillitis with symptoms of throat pain and inflammation of the\r\n             pharynx and/or tonsils;\r\n\r\n          -  Onset of sore throat less than 72 hours before inclusion ;\r\n\r\n          -  A Tonsillopharyngitis Severity Score 6;\r\n\r\n          -  Written informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Analgesics <12 hours;\r\n\r\n          -  Antibiotics <24 hours; t\r\n\r\n          -  Topical throat pain medication <4 hours;\r\n\r\n          -  Systemic corticosteroids within the last month;\r\n\r\n          -  Symptoms of primary bacterial pharyngitis or secondary bacterial infection;\r\n\r\n          -  Serious illness such as tumors; allergy to one of the ingredients; pregnancy or\r\n             lactation;\r\n\r\n          -  Hypersensitivity to ibuprofen;\r\n\r\n          -  Participation in another clinical trial in the previous 30 days.\r\n      ","sponsor":"A. Vogel AG","sponsor_type":"Industry","conditions":"Pharyngitis","interventions":[{"intervention_type":"Drug","name":"Drug: chlorhexidine/lidocaine"},{"intervention_type":"Drug","name":"Drug: echinacea/sage"}],"outcomes":[{"outcome_type":"primary","measure":"comparison of responder of the two treatment groups after the first, second, and third days. A responder is defined as a reduction by 50% of the total baseline score taken prior to treatment start.","time_frame":"first three days of treatment"},{"outcome_type":"secondary","measure":"Comparison of response rates after 4th and 5th days of treatment; VAS throat pain; amount rescue medication used; global assessment efficacy Frequency of adverse events, global assessment of tolerability","time_frame":"five days of treatment"}]}
{"nct_id":"NCT00277823","start_date":"2006-02-28","phase":"Phase 3","enrollment":480,"brief_title":"Study Evaluating Desvenlafaxine Sustained-Release (DVS-SR) in Adult Outpatients With Major Depressive Disorder","official_title":"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Fixed Doses (50 mg, 100 mg) of Desvenlafaxine Sustained-Release Tablets in Adult Outpatients With Major Depressive Disorder","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-01-31","last_update":"2007-12-28","description":"The purpose of this study is to compare the antidepressant efficacy, safety, and tolerability of DVS-SR in subjects receiving daily doses of 50 mg or 100 mg of DVS-SR versus subjects receiving placebo.","other_id":"3151A1-332","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Clinical diagnosis of major depressive disorder\r\n\r\n          -  Must be able to swallow tablets\r\n\r\n          -  Must be at least 18 years of age.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Clinical diagnosis of other psychiatric disorders\r\n\r\n          -  Significant risk of suicide\r\n\r\n          -  Unstable medical conditions.\r\n      ","sponsor":"Wyeth is now a wholly owned subsidiary of Pfizer","sponsor_type":"Industry","conditions":"Major Depressive Disorder","interventions":[{"intervention_type":"Drug","name":"Drug: DVS-SR 50 mg"},{"intervention_type":"Drug","name":"Drug: DVS-SR 100 mg"},{"intervention_type":"Drug","name":"Drug: Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"The primary objective is to compare the antidepressant efficacy, safety, and tolerability of DVS-SR in subjects receiving daily doses of 50 mg or 100 mg of DVS SR versus subjects receiving placebo."},{"outcome_type":"secondary","measure":"Additional objectives include testing both general and functional quality-of-life outcomes and satisfaction with therapy reported by the subject."}]}
{"nct_id":"NCT00283985","start_date":"2006-02-28","phase":"Phase 2","enrollment":40,"brief_title":"Association of L-asparaginase-Methotrexate-Dexamethasone for Nasal and Nasal-type Natural Killer (NK)-T-cell Lymphoma","official_title":"Phase II Study of an Association of L-asparaginase-Methotrexate-Dexamethasone for Relapsing and/or Refractory Nasal and Nasal-type NK-T-cell Lymphoma","primary_completion_date":"2012-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-06-30","last_update":"2013-02-28","description":"Nasal/nasal type NK-T-cell lymphoma is a rare and severe type of non-Hodgkin's lymphoma (NHL) more frequent in Asia than in western countries. When localised, radiotherapy seems to be the best treatment. When radiotherapy cannot be used because of dissemination or relapse, chemotherapy protocols used for other types of NHL give poor results and survival is poor. Recently papers from China and Japan reported the efficacy of a drug: l-asparaginase, usually used to treat acute lymphoblastic leukemia. In vitro a selective apoptosis of NK-cell tumours by l-asparaginase was shown on tumour cell lines and samples. The investigators propose a phase II protocol for patients with refractory or relapsing nasal/nasal type NK-T-cell lymphoma using a regimen combining l-asparaginase, methotrexate and dexamethasone. Biological studies will be conducted trying to find factors which could predict responses to this chemotherapy. Since january 2009, the study concerns all patients with nasal/nasal type NK-T-cell lymphoma who have not received asparaginase before.","other_id":"I05009","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Patients with relapsing/refractory T-NK/NK lymphoma:\r\n\r\n          -  Ages 18 years and above\r\n\r\n          -  Patients must have a diagnosis of NK-cell (or T-NK) non-Hodgkin's lymphoma, nasal or\r\n             nasal-type.\r\n\r\n          -  Stage I, II, III, or IV disease\r\n\r\n          -  Creatinine less than 3 x upper limit of normal (ULN)\r\n\r\n          -  Able to give informed consent\r\n\r\n          -  No prior treatment with asparaginase\r\n\r\n        Patients with T-NK/NK lymphoma (de novo patients ):\r\n\r\n          -  Ages 18 years and above\r\n\r\n          -  Patients must have a diagnosis of NK-cell (or T-NK) non-Hodgkin's lymphoma, nasal or\r\n             nasal-type.\r\n\r\n          -  Stage I, II, III, or IV disease\r\n\r\n          -  Creatinine less than 3 x upper limit of normal (ULN)\r\n\r\n          -  Able to give informed consent\r\n\r\n          -  no prior chemotherapy or radiotherapy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who are pregnant or nursing\r\n\r\n          -  Any factor which might limit the patient's ability to provide informed consent\r\n\r\n          -  Liver insufficiency\r\n\r\n          -  Evolutive thrombosis\r\n      ","sponsor":"University Hospital, Limoges","sponsor_type":"Other","conditions":"Lymphoma, Non-Hodgkin","interventions":[{"intervention_type":"Drug","name":"Drug: Kidrolase","description":"6000 u/ m2 IM at J2, J4 and J6 and J8. 3 to 6 cycles."},{"intervention_type":"Drug","name":"Drug: Methotrexate","description":"3 gr/m2 at J1"},{"intervention_type":"Drug","name":"Drug: Dexamethasone","description":"40 mg/ per os at J1, J2 and J4."},{"intervention_type":"Drug","name":"Drug: Erwinase","description":"In case of allergy to Kidrolase\r\n20000 u/m2 en IM at J2, J4, J6 et J8. 3 to 6 cycles"}],"outcomes":[{"outcome_type":"primary","measure":"Efficacy of chemotherapy","time_frame":"3 month, 6 month, 9 month, 12 month, 18 month, 24 month"}]}
{"nct_id":"NCT00280631","start_date":"2006-02-28","phase":"Phase 1/Phase 2","enrollment":49,"brief_title":"Study of TLK199 Tablets in Myelodysplastic Syndrome (MDS)","official_title":"Phase 1-2a Dose-Ranging Study of TLK199 Tablets in Myelodysplastic Syndrome (MDS)","primary_completion_date":"2008-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-06-30","last_update":"2012-05-31","description":"The purpose of this study is to determine the safety and efficacy of TLK199 Tablets in patients with Myelodysplastic Syndrome (MDS)","other_id":"TLK199.1101","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically confirmed diagnosis of MDS\r\n\r\n          -  Documented significant cytopenia for at least 2 months\r\n\r\n          -  Adequate liver and kidney function\r\n\r\n          -  Ineligible for stem cell bone marrow transplantation\r\n\r\n          -  At least 18 years of age\r\n\r\n          -  Discontinuation of growth factors (e.g., G-CSF) within 3 weeks of study entry\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior bone marrow transplant\r\n\r\n          -  Failure to recover from any prior surgery or any major surgery within 4 weeks of study\r\n             entry\r\n\r\n          -  Pregnant or lactating women\r\n\r\n          -  Other investigational drugs within 14 days of study entry\r\n\r\n          -  Chemotherapy, radiotherapy or immunotherapy within 14 days of study entry\r\n      ","sponsor":"Telik","sponsor_type":"Industry","conditions":"Myelodysplastic Syndrome (MDS)","interventions":[{"intervention_type":"Drug","name":"Drug: Ezatiostat Hydrochlorine","description":"Oral Tablets in 2 Divided Doses, Dose Escalation From 200 mg Per Day to 6000 mg Per Day on Days 1-7 of each 21 Day Cycle."}],"outcomes":[{"outcome_type":"primary","measure":"Maximum Tolerated Dose or Optimal Biologic Dose","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Safety Pharmacokinetic Parameters, Hematologic Response Parameters","time_frame":"6 months"}]}
{"nct_id":"NCT00365144","start_date":"2006-02-28","phase":"Phase 2","enrollment":36,"brief_title":"Bevacizumab and Erlotinib in Treating Patients With Metastatic Pancreatic Cancer That Did Not Respond to Previous Treatment With Gemcitabine","official_title":"A Phase II Trial of Bevacizumab Plus Erlotinib for Patients With Metastatic Gemcitabine-Refractory Pancreatic Cancer","primary_completion_date":"2009-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-03-31","last_update":"2018-01-19","description":"RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of pancreatic cancer by blocking blood flow to the tumor. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving bevacizumab together with erlotinib may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving bevacizumab together with erlotinib works in treating patients with metastatic pancreatic cancer that did not respond to previous treatment with gemcitabine.","other_id":"054511","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":120,"population":"","criteria":"\n        DISEASE CHARACTERISTICS:\r\n\r\n          -  Histologically or cytologically confirmed adenocarcinoma of the pancreas\r\n\r\n          -  Documented extrapancreatic metastases\r\n\r\n               -  Radiographically measurable disease not required\r\n\r\n          -  Gemcitabine hydrochloride-refractory disease\r\n\r\n               -  Has undergone 1-3 prior therapies for locally advanced or metastatic disease with\r\n                   1 regimen containing gemcitabine hydrochloride (alone or in combination with\r\n                  other agents)\r\n\r\n                    -  Treatment given in the adjuvant setting (radiotherapy and/or chemotherapy,\r\n                       given either concurrently or systemically) does not count as prior therapy\r\n                       as long as progressive disease occurs > 6 months after completion of\r\n                       treatment\r\n\r\n          -  No central nervous system (CNS) or brain metastases\r\n\r\n        PATIENT CHARACTERISTICS:\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1\r\n\r\n          -  Absolute neutrophil count  1,500/mm\r\n\r\n          -  Platelet count  100,000/mm\r\n\r\n          -  International Normalized Ratio (INR)  1.5 (except in patients receiving full-dose\r\n             warfarin)\r\n\r\n          -  Bilirubin  2.0 mg/dL\r\n\r\n          -  Creatinine  2.0 mg/dL\r\n\r\n          -  AST or ALT  2.5 times upper limit of normal (ULN) (5 times ULN if documented liver\r\n             metastases)\r\n\r\n          -  Hemoglobin  9 g/dL (transfusion or epoetin alfa allowed)\r\n\r\n          -  No contact lense use during and for 14 days after completion of study treatment\r\n\r\n          -  Not pregnant or nursing\r\n\r\n          -  Negative pregnancy test\r\n\r\n          -  Fertile patients must use effective contraception during and for  6 months after\r\n             completion of study treatment\r\n\r\n          -  No history of other disease, metabolic dysfunction, or physical examination or\r\n             clinical laboratory finding that contraindicates use of an investigational drug or\r\n             precludes study compliance\r\n\r\n          -  No history of serious systemic disease, including any of the following:\r\n\r\n               -  Myocardial infarction within the past 6 months\r\n\r\n               -  Stroke within the past 6 months\r\n\r\n               -  Uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg on medication)\r\n\r\n               -  Unstable angina\r\n\r\n               -  New York Heart Association class II-IV congestive heart failure\r\n\r\n               -  Unstable symptomatic arrhythmia requiring medication\r\n\r\n                    -  Chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal\r\n                       supraventricular tachycardia) allowed\r\n\r\n               -  Peripheral vascular disease  grade 2\r\n\r\n          -  No significant traumatic injury within the past 28 days\r\n\r\n          -  No proteinuria (defined as urine protein:creatinine ratio  1.0 at screening)\r\n\r\n          -  No clinically significant impairment of renal function\r\n\r\n          -  No serious, nonhealing wound, ulcer, or bone fracture\r\n\r\n          -  No evidence of bleeding diathesis or coagulopathy\r\n\r\n          -  No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal\r\n             abscess within the past 6 months\r\n\r\n        PRIOR CONCURRENT THERAPY:\r\n\r\n          -  More than 28 days since prior major surgery or open biopsy\r\n\r\n          -  More than 7 days since prior fine-needle aspiration or core biopsy\r\n\r\n          -  No prior antiangiogenesis agent (e.g., bevacizumab or an oral vascular endothelial\r\n             growth factor receptor small molecule inhibitor) given together with an agent that\r\n             disrupts epidermal growth factor receptor signaling (e.g., cetuximab or erlotinib\r\n             hydrochloride) for locally advanced or metastatic pancreatic cancer\r\n\r\n               -  Prior treatment with either one of the above alone allowed\r\n\r\n          -  More than 4 weeks since prior and no concurrent participation in another clinical\r\n             trial\r\n\r\n          -  No other concurrent antineoplastic or antitumor agents, including chemotherapy,\r\n             radiotherapy, immunotherapy, or hormonal anticancer therapy\r\n\r\n          -  No concurrent major surgery\r\n\r\n          -  No other concurrent investigational agents\r\n      ","sponsor":"University of California, San Francisco","sponsor_type":"Other","conditions":"Pancreatic Cancer","interventions":[{"intervention_type":"Biological","name":"Biological: bevacizumab"},{"intervention_type":"Drug","name":"Drug: erlotinib hydrochloride"},{"intervention_type":"Other","name":"Other: laboratory biomarker analysis"}],"outcomes":[{"outcome_type":"primary","measure":"Overall Survival Rate at 6 Months","time_frame":"6 months","description":"Number of participants alive at 6 months"},{"outcome_type":"primary","measure":"Safety and Toxicity","time_frame":"21 weeks","description":"Treatment associated toxicities. Adverse event assessments were performed on day 1 of each treatment cycle and at the end of treatment; the longest duration of treatment was 7 cycles (x 3 weeks)"},{"outcome_type":"secondary","measure":"Objective Response as Measured by RECIST Criteria","time_frame":"21 weeks","description":"Participants experiencing objecting response, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."},{"outcome_type":"secondary","measure":"Time to Tumor Progression","time_frame":"from initial therapy to the first objective documentation of tumor progression","description":"Time to tumor progression (TTP) was defined as the time from initial therapy to the first objective documentation of tumor progression (for patients with measurable disease) or to the data of death, if death was ascribed to progression of disease."},{"outcome_type":"secondary","measure":"Proportion of Patients With ≥ 25% Decline in Serum CA19-9 Biomarker","time_frame":"21 weeks"}]}
{"nct_id":"NCT00453791","start_date":"2006-02-07","phase":"Phase 1","enrollment":31,"brief_title":"The Safety and Tolerability of GW805858 in Healthy Volunteers and Mild Asthmatics","official_title":"A Randomised, Single and Repeat Dose, Double-blind, Placebo Controlled Study to Assess the Safety and Tolerability of GW805858 in Healthy Volunteers and Mild Asthmatics","primary_completion_date":"2006-04-10","study_type":"Interventional","rec_status":"Terminated","completion_date":"2006-04-10","last_update":"2017-09-29","description":"This study will be the First Time in Human Study (FTIH) aiming to assess the safety and tolerability of GW805858 for both single and repeat dose. The study also aims to assess safety and tolerability in mild asthmatic subjects as well as healthy volunteers.","other_id":"SF2105450","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Men or women of non-child bearing potential, aged between 18 and 60 years of age\r\n             inclusive.\r\n\r\n          -  Body weight = 50 kg (110 lbs) for men and = 45 kg for women and Body Mass Index (BMI)\r\n             within the range 19.0-30.0 kg/m2 inclusive.\r\n\r\n          -  The subject is a current non-smoker who has not used any tobacco products in the last\r\n             year.\r\n\r\n          -  A signed and dated written informed consent is obtained for the subject.\r\n\r\n          -  The subject is able to understand and comply with protocol requirements and\r\n             timetables, instructions and protocol-stated restrictions.\r\n\r\n          -  If asthmatic, the subject must be a clinically stable asthmatic.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  The subject has a history of allergy to ingredients within the inhaler.\r\n\r\n          -  The subject has received an investigational drug or participated in any other research\r\n             trial within 30 days, prior to the first dose of current study medication.\r\n\r\n          -  The subject has used prescription or non-prescription drugs, including vitamins,\r\n             herbal and dietary supplements (including St John's Wort) within 14 days prior to the\r\n             first dose of study medication.\r\n\r\n          -  The subject has an average weekly alcohol intake of greater than 21 units if male or\r\n             14 units if female.\r\n\r\n          -  The subject has any history of breathing problems (e.g. history of asthmatic\r\n             symptoms).\r\n\r\n          -  The subject is infected with the hepatitis B, hepatitis C, or HIV virus.\r\n\r\n          -  The subject has had a respiratory tract infection or worsening of asthma within 4\r\n             weeks of the start of the study.\r\n\r\n          -  The subject has a past or present disease, which as judged by the Investigator, may\r\n             affect the outcome of this study.\r\n\r\n          -  The subject has a history of life-threatening asthma, defined as an asthma episode\r\n             that required intubation and/or was associated with hypercapnea, respiratory arrest or\r\n             hypoxia seizures.\r\n\r\n          -  The subject has taken inhaled, nasal or dermal steroids within 4 weeks or oral\r\n             steroids within 8 weeks of the start of the study.\r\n\r\n          -  The subject is unable to abstain from other drugs that may interfere with the conduct\r\n             of the study.\r\n\r\n          -  The subject has ongoing rhinitis that requires treatment.\r\n      ","sponsor":"GlaxoSmithKline","sponsor_type":"Industry","conditions":"Asthma","interventions":[{"intervention_type":"Drug","name":"Drug: GW805858","description":"GW805858 MDI will be given with dose of 150 micrograms per metered actuation and 120 actuations per inhaler. GW805858 MDI comprises a solution of GW805858 in a liquefied hydrofluoroalkane propellant (1,1,1,2-tetrafluoroethane) which is contained in an aluminium alloy can, internally coated with a specified fluoropolymer, fitted with a metering valve."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo MDI will be given to the subjects."}],"outcomes":[{"outcome_type":"primary","measure":"Safety and tolerability parameters will be compared between active and placebo treatment groups using summary statistics. No formal statistical analyses of the safety and tolerability data will be performed.","time_frame":"Up to 18 weeks"},{"outcome_type":"secondary","measure":"Derived GW805858 and GW288967 PK parameters will be compared between active and placebo treatment groups using summary statistics.","time_frame":"Pre-dose, 5,20,30,45,60,90 minutes, 2,3,4,6,8,10,12,12.5,13,14, 24 hours Post-dose on Days 1 and 28."}]}
{"nct_id":"NCT00276159","start_date":"2006-01-31","phase":"Phase 2","enrollment":6,"brief_title":"Study of Immune Response Modifier in the Treatment of Hematologic Malignancies","official_title":"Phase II Study of 852A Administered Subcutaneously in Patients With Hematologic Malignancies Not Responding to Standard Treatment","primary_completion_date":"2008-11-30","study_type":"Interventional","rec_status":"Terminated","completion_date":"2008-11-30","last_update":"2019-09-04","description":"The purpose of this study is to evaluate the anti-tumor activity of 852A when used to treat certain hematologic malignancies not responding to standard treatment.","other_id":"05US02IMP-852A","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","population":"","criteria":"\n        Subjects are eligible for the study if they meet all of the following\r\n\r\n        Inclusion Criteria:\r\n\r\n          -  Diagnosis of one of the following hematologic malignancies not responding to at least\r\n             2 standard treatment regimens. Any criteria for persistent or recurrent disease\r\n             acceptable, i.e. 5% blasts for acute leukemia.\r\n\r\n               -  acute lymphoblastic leukemia (ALL)\r\n\r\n               -  acute myeloid leukemia (AML)\r\n\r\n               -  non-Hodgkin's lymphoma (NHL)\r\n\r\n               -  Hodgkin's lymphoma (HL)\r\n\r\n               -  multiple myeloma (MM)\r\n\r\n               -  chronic lymphocytic leukemia (CLL)\r\n\r\n          -  Performance status - Karnofsky > 50% for patients > 10 years of age or Lansky >50% for\r\n             patients < 10 year of age\r\n\r\n          -  Normal organ function within 14 days of study entry\r\n\r\n          -  If female and of childbearing potential, are willing to use adequate contraception\r\n             (hormonal, barrier method, abstinence) prior to study entry and for the duration of\r\n             study participation. A female is considered to be of childbearing potential unless she\r\n             has had her uterus removed, had a double oophorectomy, or has been amenorrheic for at\r\n             least 6 months after chemotherapy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Had/have the following prior/concurrent therapy:\r\n\r\n               -  Systemic corticosteroids (oral or injectable) within 7 days of first dose of 852A\r\n                  (topical or inhaled steroids are allowed)\r\n\r\n               -  Investigational drugs/agents within 14 days of first dose of 852A\r\n\r\n               -  Immunosuppressive therapy, including cytotoxic agents within 14 days of first\r\n                  dose of 852A (nitrosoureas within 30 days of first dose)\r\n\r\n               -  Drugs known to induce QT interval prolongation and/or induce Torsades De Pointes\r\n                  unless best available drug required to treat life-threatening conditions\r\n\r\n               -  Radiotherapy within 4 weeks of the first dose of 852A\r\n\r\n               -  Hematopoietic cell transplantation 4 weeks of first dose of 852A\r\n\r\n          -  Active infection or fever > 38.5C within 3 days of first dose of 852A\r\n\r\n          -  Cardiac ischemia, cardiac arrhythmias or congestive heart failure uncontrolled by\r\n             medication\r\n\r\n          -  History of, or clinical evidence of, a condition which, in the opinion of the\r\n             investigator, could confound the results of the study or put the subject at undue risk\r\n\r\n          -  Uncontrolled intercurrent or chronic illness\r\n\r\n          -  Active autoimmune disease requiring immunosuppressive therapy within 30 days\r\n\r\n          -  Active hepatitis B or C with evidence of ongoing viral replication\r\n\r\n          -  Hyperthyroidism\r\n\r\n          -  Uncontrolled seizure disorder\r\n\r\n          -  Active coagulation disorder not controlled with medication\r\n\r\n          -  Pregnant or lactating\r\n\r\n          -  Concurrent malignancy (if in remission, at least 5 years disease free) except for\r\n             localized (in-situ) disease, basal carcinomas and cutaneous squamous cell carcinomas\r\n             adequately treated\r\n\r\n          -  Proven active central nervous system (CNS) disease\r\n\r\n          -  Human Immunodeficiency Virus (HIV) positive\r\n\r\n          -  Congenital long QT syndrome or abnormal baseline QTc interval (> 450 msec in males and\r\n             > 470 msec in females) after Bazett's correction (QTc msec = QT msec / square root of\r\n             the RR interval in seconds) on screening electrocardiogram (ECG).\r\n      ","sponsor":"Masonic Cancer Center, University of Minnesota","sponsor_type":"Other","conditions":"Acute Lymphoblastic Leukemia|Acute Myeloid Leukemia|Non-Hodgkin's Lymphoma|Hodgkin's Lymphoma|Multiple Myeloma|Chronic Lymphocytic Leukemia","interventions":[{"intervention_type":"Drug","name":"Drug: 852A","description":"Subcutaneous injection 0.6 mg/m2 2 times/week/12 weeks, may increase by 0.2 mg/m2 up to 1.2 mg/m2."}],"outcomes":[{"outcome_type":"primary","measure":"Number of Patients With 852A Response Using Modified Response Evaluation Criteria in Solid Tumors","time_frame":"Up to Week 12","description":"Stable disease in Non-Hogkin's Lymphoma = disease that does not satisfy complete (complete regression), partial (> or = 50% reduction) or progressive disease (increase of 25%) by at least a 4-week period. Since Acute Myelogenous Leukemia is not a solid tumor, Complete Response (CR) = <5% blasts with hematopoietic recovery (absolute neutrophil count >500) at 4 weeks."},{"outcome_type":"secondary","measure":"Number of Patients Who Received Steroids","time_frame":"Up to Week 12","description":"Number of patients who received steroids allowing successful continuation of therapy."},{"outcome_type":"secondary","measure":"Measure of Immune Activation With Correlative Laboratory Studies","time_frame":"Up to Week 12"},{"outcome_type":"secondary","measure":"Peak Concentrations of 852A","time_frame":"Up to Week 12","description":"Measurement of peak concentrations of 852A to correlate the side effects of tolerability in patients."}]}
{"nct_id":"NCT01300754","start_date":"2006-01-31","phase":"Phase 1/Phase 2","enrollment":54,"brief_title":"Effectiveness of Dextrose Injection for Osgood-Schlatter Disease","official_title":"Phase 2 Study of Dextrose Injection for Sport-Limiting Osgood Schlatter Disease in Adolescents.","primary_completion_date":"2009-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-09-30","last_update":"2011-02-23","description":"Objective: To examine the potential of dextrose injection versus lidocaine injection versus supervised usual care to change pain/function/activity levels in adolescent athletes with Osgood-Schlatter Disease (OSD).","other_id":"UNRosario","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":9,"maximum_age":17,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age:9-15 year old girls and 10-17 year old boys\r\n\r\n          -  Pain Location: Anterior knee.\r\n\r\n          -  Sport Type: Jumping or kicking sport.\r\n\r\n          -  Team Member with Coach: Member of and organized team with a coach.\r\n\r\n          -  Imitation of exact pain and precise location to the tibial tuberosity with a single\r\n             leg squat.\r\n\r\n          -  At least 2 months of formal and gently progressive hamstring stretching, quads\r\n             strengthening, and gradual sports reintroduction.\r\n\r\n          -  Pain with sport at least 3 months.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patellofemoral crepitus\r\n\r\n          -  Patellar origin tenderness\r\n      ","sponsor":"Universidad Nacional de Rosario","sponsor_type":"Other","conditions":"Osgood-Schlatter Disease","interventions":[{"intervention_type":"Procedure","name":"Procedure: Dextrose Injection","description":"12.5 Dextrose in 1% Lidocaine injected monthly for 3 months with a 27 gauge needle on painful areas of the tibial tuberosity, under the patellar tendon."},{"intervention_type":"Procedure","name":"Procedure: Lidocaine Injection","description":"1% Lidocaine injected monthly for 3 months with a 27 gauge needle on painful areas of the tibial tuberosity, under the patellar tendon."},{"intervention_type":"Other","name":"Other: Usual Care","description":"Therapist supervised exercises that are standard of care for Osgood-Schatter Disease as well as relative rest and gradual resumption of pain-limited sport."}],"outcomes":{}}
{"nct_id":"NCT00724399","start_date":"2006-01-31","enrollment":1418,"brief_title":"Preventive Health Practices in Women","official_title":"Preventive Health Practices in Women","primary_completion_date":"2015-05-31","study_type":"Observational","rec_status":"Completed","completion_date":"2015-05-31","last_update":"2016-12-16","description":"The purpose of this study is to evaluate women's level of knowledge and health practices regarding cardiovascular health and identify barriers to appropriate health practice.","other_id":"HUM00010173","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"Female","population":"Prospective survey study on women who attend screening mammography and routine/annual\r\n        gynecology visits to assess baseline knowledge regarding CVD.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Women attending screening mammography and gynecology visit.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patient refusal to participate (assessed by non-submission of the completed survey).\r\n      ","sponsor":"University of Michigan","sponsor_type":"Other","conditions":"Cardiovascular Disease","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Survey on womens health Issues.","description":"Cardiovascular health."}],"outcomes":[{"outcome_type":"primary","measure":"To validate findings in a population of women undergoing screening mammography and annual gynecology visit to identify current state of knowledge regarding cardiovascular risk in women.","time_frame":"To be determined later"}]}
{"nct_id":"NCT00956683","start_date":"2006-01-31","phase":"N/A","enrollment":106,"brief_title":"Dual Endpoint Nerve Stimulation Versus Ultrasound in Infraclavicular Block for Hand Surgery","official_title":"A Randomized Controlled Study Comparing Dual Endpoint Nerve Stimulation With Ultrasound-guided Infraclavicular Block for Hand Surgery.","primary_completion_date":"2008-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-12-31","last_update":"2009-08-11","description":"Current best practice for performance of infraclavicular block dictates the use of a dual-endpoint nerve stimulation technique that still only results in a 79% success rate. Use of an ultrasound-guided technique has the potential to significantly improve success. A randomized, controlled study to evaluate this area remains to be performed and is required to demonstrate to anesthesiologists that an ultrasound-guided approach should supersede nerve stimulation as the technique of choice for infraclavicular block.","other_id":"2004-006","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients undergoing elective upper limb surgery at or below the elbow.\r\n\r\n          -  Patients aged >18 and <80 years\r\n\r\n          -  ASA I-III\r\n\r\n          -  BMI<35\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Inability to read, write or speak English. (This is necessary because subjects will\r\n             have to follow detailed instructions to allow testing of motor and sensory function.\r\n             It is not feasible to have an interpreter present in the block room during performance\r\n             of these procedures)\r\n\r\n          -  Contraindication to brachial plexus block\r\n\r\n          -  Existing neurological deficit in the area to be blocked\r\n\r\n          -  Known loco-regional malignancy or infection\r\n\r\n          -  Coagulopathy\r\n\r\n          -  Allergy to local anesthetic agents.\r\n\r\n          -  Chest or shoulder deformities\r\n\r\n          -  Severe respiratory disease\r\n\r\n          -  Healed but dislocated clavicle fracture\r\n      ","sponsor":"University Health Network, Toronto","sponsor_type":"Other","conditions":"Hand Surgery","interventions":[{"intervention_type":"Procedure","name":"Procedure: Ultrasound Guided Infraclavicular Nerve Block","description":"Use of Ultrasound to help guide needle placement and local anesthetic injection during infraclavicular nerve block."},{"intervention_type":"Procedure","name":"Procedure: Dual-Endpoint nerve stimulation","description":"Use of dual-endpoint nerve stimulation to guide needle placement and local anesthetic injection during infraclavicular nerve block."}],"outcomes":[{"outcome_type":"primary","measure":"To compare ultrasound-guided infraclavicular block with conventional dual-endpoint nerve stimulator guided infraclavicular block with regards to block success, ease of nerve localization, speed of onset, duration of block and complications."}]}
{"nct_id":"NCT00282932","start_date":"2006-01-31","phase":"Phase 4","enrollment":600,"brief_title":"Detrol LA In Men With Overactive Bladder.","official_title":"A Randomized, Double Blind, Placebo Controlled Detrol LA \"Add-On\" To Alpha-Blocker Study In Men With Persistent Overactive Bladder Symptoms Of Urinary Frequency And Urgency With/Without Urgency Incontinence After Previous Monotherapy With Alpha Blocker.","primary_completion_date":"2007-05-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-05-14","last_update":"2021-01-27","description":"An interventional active/placebo double blinded parallel randomized controlled study in which at 12 weeks of treatment, the primary endpoint of patient perception of bladder condition is measured along with associated safety and other secondary endpoints like bladder diary endpoints, quality of life and patient treatment satisfaction. Patients included in the study must have symptoms of OAB (frequency of at least 8 per day and Urgency of at least 1 episode per day confirmed by bladder diary). Patients are not eligible to enroll in the study if they have/had significant hepatic or renal disease, history of radiation treatment.","other_id":"A6121127","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"Male","minimum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Symptoms of OAB (frequency more than 8 per day and Urgency more than 1 episode per day\r\n             confirmed by bladder diary)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Significant hepatic or renal disease, history of radiation treatment\r\n      ","sponsor":"Pfizer's Upjohn has merged with Mylan to form Viatris Inc.","sponsor_type":"Industry","conditions":"Overactive Bladder (OAB)","interventions":[{"intervention_type":"Drug","name":"Drug: Detrol LA"}],"outcomes":[{"outcome_type":"secondary","measure":"f)On sexual QoL as assessed by the ICIQ-MLUTSsex Questionnaire , g)On patient satisfaction with medication as assessed by the Overactive Bladder Treatment Satisfaction Questionnaires (OAB-s), h)On nocturia bothersome measure as assessed by the Nocturia"},{"outcome_type":"primary","measure":"Patient Perception of Bladder Condition at 12 weeks of treatment"},{"outcome_type":"secondary","measure":"1)To evaluate the additional benefit of 'Add-On' tolterodine L-tartrate ER (Detrol LA?), vs. placebo, to alpha-blocker therapy in men with persistent OAB symptoms of urinary frequency and urgency with/without urgency incontinence: a)On OAB symptoms as"},{"outcome_type":"secondary","measure":"assessed by 5-day voiding bladder diaries including Urinary Sensation Scale, b)On symptoms as assessed by the International Prostate Symptom Score (IPSS), c)On patient perception of treatment benefit as assessed by the Patient Perception of Treatment"},{"outcome_type":"secondary","measure":"Benefit Questionnaire (PPTB) , d)On patient perception of bladder condition as assessed by the change in the PPBC after 4 weeks of treatment, e)On bothersome quality of life (QoL) symptoms as assessed by the Overactive Bladder Questionnaire (OAB-q),"},{"outcome_type":"secondary","measure":"Quality-of-Life Questionnaire, 2)To evaluate the safety and tolerability of 'Add-On' tolterodine L-tartrate ER (Detrol LA?), vs. placebo, to alpha-blocker therapy in men with persistent OAB symptoms of urinary frequency and urgency with/without urgency"},{"outcome_type":"secondary","measure":"incontinence."}]}
{"nct_id":"NCT00726609","start_date":"2006-01-31","enrollment":214,"brief_title":"Post-marketing Surveillance Study of Invasive Mycosis With Posaconazole (Study P04641)","official_title":"Post-marketing Surveillance (PMS) Management of Invasive Mycosis With Posaconazole","primary_completion_date":"2008-07-31","study_type":"Observational","rec_status":"Completed","completion_date":"2008-07-31","last_update":"2015-03-05","description":"The purpose of this postmarketing surveillance study is to collect an extensive body of data in a large patient population in every day life to investigate the safety and efficacy of NOXAFIL (posaconazole) in the treatment of invasive fungal disease.","other_id":"P04641","observational_model":"Case-Only","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"Subjects with invasive fungal infection refractory to first-line treatment or unable to\r\n        tolerate it were selected at hospitals in Germany.\r\n\r\n        Following the enlargement of the marketing authorization for posaconazole, subjects at risk\r\n        for invasive fungal infection were also enrolled.","criteria":"\n        Inclusion Criteria:\r\n\r\n        Adult subjects with:\r\n\r\n          -  Invasive aspergillosis refractory to, or intolerant of, amphotericin B or\r\n             itraconazole,\r\n\r\n          -  Fusariosis refractory to, or intolerant of, amphotericin B,\r\n\r\n          -  Chromoblastomycosis and mycetoma refractory to, or intolerant of, itraconazole,\r\n\r\n          -  Coccidiomycosis refractory to, or intolerant of, amphotericin B, itraconazole or\r\n             fluconazole.\r\n\r\n          -  Subjects receiving remission-induction chemotherapy for acute myelogenous leukemia\r\n             (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia\r\n             and who are at high risk for developing invasive fungal infections.\r\n\r\n          -  Hematopoietic stem-cell transplant (HSCT) recipients who are undergoing high-dose\r\n             immunosuppressive therapy for Graft-versus-host disease and who are at high risk for\r\n             developing invasive fungal infections.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Comedication of the participant with ergotamine, dihydroergotamine, terfenadine,\r\n             astemizole, cisapride, pimozide, halofantrine, or chinidine.\r\n      ","sponsor":"Merck Sharp & Dohme Corp.","sponsor_type":"Industry","conditions":"Mycoses","interventions":[{"intervention_type":"Drug","name":"Drug: Posaconazole","description":"The usual dose of NOXAFIL is 400 mg twice daily (10 mL) at meals or with 240 mL of a food supplement. For patients unable to take meals or food supplements, NOXAFIL is administered at a dose of 200 mg (5 mL) four times daily."}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants Reporting Adverse Drug Reactions.","time_frame":"Before starting treatment with posaconazole, during treatment, and until 100 days after treatment.","description":"The severity of an Adverse Drug Reaction is determined on the basis of the following definitions:\r\nMild: The abnormality, symptom or event is noticed but well tolerated.\r\nModerate: Symptoms impair normal activities and may require intervention.\r\nSevere: Clinical status is significantly impaired, normal activity is no longer possible, intervention is required."}]}
{"nct_id":"NCT00380380","start_date":"2006-01-31","phase":"Phase 3","enrollment":18,"brief_title":"A Study to Assess the Acute Effects of Vildagliptin on Gastric Emptying in Patients With Type 2 Diabetes.","official_title":"A Randomized, Single-blind, Placebo Controlled, Cross-over Study to Evaluate the Acute Effects of Vildagliptin on Gastric Emptying in Patients With Type 2 Diabetes.","primary_completion_date":"2006-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2006-11-30","last_update":"2017-02-23","description":"Please note this study is not being conducted in the United States. The purpose of this study is to assess the acute effects of vildagliptin, an unapproved drug, in reducing post-meal glucose levels by delaying gastric emptying.","other_id":"CLAF237A2378","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":30,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Must be able to complete a 1-week wash-out of current anti-diabetic medications\r\n\r\n          -  Cannot take any medications which may alter gastric motility except for cardiac\r\n             medication at a stable dose\r\n\r\n          -  Blood glucose criteria must be met\r\n\r\n          -  BMI <40\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of type 1 diabetes, diabetes resulting from pancreatic injury, or secondary\r\n             forms of diabetes\r\n\r\n          -  Need for insulin within 3 months or patients on thiazolidinediones\r\n\r\n          -  Significant concommitant disease or complications of diabetes\r\n\r\n          -  Patients with any history of gastrointestinal surgery or positive gastrointestinal\r\n             symptons\r\n\r\n          -  Abnormal liver function tests as defined by the protocol\r\n\r\n          -  Other protocol-defined inclusion/exclusion criteria may apply\r\n      ","sponsor":"Novartis","sponsor_type":"Industry","conditions":"Diabetes Mellitus, Type 2","interventions":[{"intervention_type":"Drug","name":"Drug: Vildagliptin"}],"outcomes":[{"outcome_type":"primary","measure":"Evaluate the effects of acute effects of vildagliptin on gastric emptying"},{"outcome_type":"secondary","measure":"Effect on steady state levels of active GLP-1 and GIP"},{"outcome_type":"secondary","measure":"Change in fasting and postprandial glucose levels."},{"outcome_type":"secondary","measure":"Change in glucagon secretion"},{"outcome_type":"secondary","measure":"Change in postprandial glucose kinetics"},{"outcome_type":"secondary","measure":"Effect on gastric peristalsis"},{"outcome_type":"secondary","measure":"Effect on satiety"}]}
{"nct_id":"NCT00307684","start_date":"2006-01-31","phase":"Phase 3","enrollment":155,"brief_title":"Open Label, Multicentre Extension Study of Protocol 42603ATT3002 to Evaluate Safety of Prolonged Release OROS Methlyphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD)","official_title":"An Open International Multicentre Long-Term Follow Up Study to Evaluate Safety of Prolonged Release OROS Methlyphenidate in Adults With Attention Deficit Hyperactivity Disorder","primary_completion_date":"2008-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-07-31","last_update":"2014-04-21","description":"Trial 42603ATT3004 is an open-label extension study to clinical trial 42603ATT3002 (NCT00246220). In trial 42603ATT3002 the efficacy and safety of OROS methylphenidate was assessed in adult subjects with Attention Deficit Hyperactivity Disease (ADHD). ADHD is a developmental disorder beginning in childhood and characterized by developmentally inappropriate inattention, hyperactivity and impulsiveness. Data on the number of adult patients with ADHD is limited, but it is estimated that approximately 50% of children with ADHD will have symptoms also in adhulthood. The drug tested in this trial is OROS methylphenidate. The active ingredient is methylphenidate and the tablet is designed to release the active ingredient gradually to ensure an effect, which lasts up to 12 hours. Trial 42603ATT3002 consisted of a 5-week period, where subjects were assigned to either receive placebo (empty drug) or one out of three different dosages of OROS methylphenidate. This 5-week period was followed by a 7-week period, where patients received OROS methylphenidate at their optimal dose. In study 42603ATT3004, subjects who complete 42603ATT3002 are followed for a period of at least 52 weeks to evaluate safety and tolerability of OROS methylphenidate in patients who are treated with OROS methylphenidate over a long period of time. Amendment: At the end of the open-label period of the present study 42603ATT3004, patients are enrolled into a double-blind placebo-controlled period, which lasts an additional 4 weeks. The purpose of this double-blind placebo-controlled period is to evaluate the maintenance of effect under continued treatment with OROS methlyphenidate in comparison to treatment cessation in those patients, who are randomized into the placebo-group.","other_id":"CR011068","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patient has completed study CR002479 (42603ATT3002), according to protocol\r\n\r\n          -  Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental\r\n             Diseases, Fourth Edition (DSM-IV)1 and confirmed by the Conners' Adult ADHD Diagnostic\r\n             Interview for DSM IV (CAADID)\r\n\r\n          -  Healthy on the basis of physical examination, medical history\r\n\r\n          -  Patient is able to comply with the study visit schedule and willing and able to\r\n             complete the protocol-specified assessments\r\n\r\n          -  Amendment (double-blind placebo-controlled period): written informed consent\r\n\r\n          -  patient must have completed at least 52 weeks of open-label treatment and must have\r\n             been on a stable daily dose of (PR) OROS methlyphenidate prior to inclusion to this\r\n             phase\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patient is known to be a non-responder to methylphenidate, or patient has a child\r\n             known to be a non-responder to methylphenidate\r\n\r\n          -  Allergy or hypersensitivty to methlyphenidate\r\n\r\n          -  Any clinically unstable psychiatric condition including but not limited to the\r\n             following: acute mood disorder, bipolar disorder, acute obsessive-compulsive disorder\r\n             (OCD), Anti-social personality disorder, borderline personality disorder\r\n\r\n          -  Use of other anti-depressants (unless patient has been on a stable dosage during the\r\n             42603ATT3002 trial, in which case treatment may continue as long as dosage remains\r\n             unchanged for the duration of the study) or mood stabilisers (e.g. anti-epileptics,\r\n             lithium)\r\n\r\n          -  Any medication likely to interfere with safe administration of methylphenidate, or any\r\n             conditions that are contraindicated for use of methlyphenidate\r\n      ","sponsor":"Janssen-Cilag International NV","sponsor_type":"Industry","conditions":"Attention Deficit Disorder With Hyperactivity","interventions":[{"intervention_type":"Drug","name":"Drug: double blind placebo","description":"matching placebo tablets once daily for 4 weeks"},{"intervention_type":"Drug","name":"Drug: double blind PR OROS methylphenidate","description":"18, 36, 54,72 or 90 mg/day once daily for 4 weeks"},{"intervention_type":"Drug","name":"Drug: open label PR OROS methylphenidate","description":"Flexible dosage MPH (18 to 90 mg/day) for 72 weeks (108 weeks for Germany)"}],"outcomes":[{"outcome_type":"primary","measure":"Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs)","time_frame":"Treatment duration for OL extended from 52 wks to 72 wks (International Amendment 2) or 108 wks in Germany. Treatment duration for double-blind (DB) randomized withdrawal: 4 weeks","description":"To evaluate the long term safety and tolerability of PR OROS MPH (18, 36, 54, 72 and 90 mg/day) in adults with Attention Deficit Hyperactivity Disorder (ADHD)"},{"outcome_type":"primary","measure":"Change From DB Baseline in Conners' Adult ADHD Rating Scale (CAARS) Total Score at DB Endpoint","time_frame":"DB baseline, DB endpoint","description":"To evaluate maintenance of treatment effects of PR OROS MPH vs. placebo as measured on CAARS.\r\nCAARS assesses ADHD symptoms and behaviors in adults. best value: 0 worst value: 54\r\nEndpoint: last available post-baseline assessment."},{"outcome_type":"secondary","measure":"Change From OL Baseline to OL Endpoint in Conners' Adult ADHD Rating Scale (CAARS) Total and Subscale Scores","time_frame":"OL baseline, OL endpoint","description":"Long term efficacy of PR OROS MPH as assessed by investigator-rated CAARS total score, hyperactivity/impulsivity subscale score and inattention subscale score.\r\nSubscale scores: best value: 0, worst value: 27"},{"outcome_type":"secondary","measure":"Change From OL Baseline in Clinical Global Impression Scale (CGI-S) Score at OL Endpoint","time_frame":"OL baseline, OL endpoint","description":"Assessment of the long term effect on overall functioning measured by CGI-S best score: 1 worst score: 7"},{"outcome_type":"secondary","measure":"Change From OL Baseline in Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score at OL Endpoint","time_frame":"OL baseline, OL endpoint","description":"Quality of life measured by Q-LES-Q best score: 100 worst score: 0"},{"outcome_type":"secondary","measure":"Change From DB Baseline to DB Endpoint in CGI-S Score","time_frame":"DB baseline, DB endpoint","description":"evaluation of treatment effects as rated by the investigator on the CGI-S scale. CGI-S is used to rate the severity of a subject's illness on a 7- point scale ranging from 1 (not ill) to 7 (extremely severe)."},{"outcome_type":"secondary","measure":"Change From DB Baseline to DB Endpoint in CAARS Self Rated Scale (CAARS-S:S) Total Score","time_frame":"DB baseline, DB endpoint","description":"Evaluation of treatment effects as rated by the subjects on the CAARS-S:S. best score: 0 worst score: 104"}]}
{"nct_id":"NCT00497939","start_date":"2006-01-31","phase":"N/A","enrollment":40,"brief_title":"The Effectiveness of Saw Palmetto and Sanmiaoshan on Benign Prostatic Hyperplasia in Chinese Patients","official_title":"The Effectiveness of Saw Palmetto and Sanmiaoshan on International Prostate Symptom Score and Peak Urinary Flow Rate of Chinese Patients With Benign Prostatic Hyperplasia","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2008-03-31","last_update":"2010-07-07","description":"The purpose of this study is to assess the effect of saw palmetto and sanmiaoshan, on top of alpha blocker, on urinary flow rate and BPH symptoms in patients with BPH.","other_id":"CRE-2005.310-T","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"Male","minimum_age":50,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age between 50 and 80 years old\r\n\r\n          -  Clinically diagnosed to have BPH:\r\n\r\n               -  Suffered from lower urinary tract symptoms with IPSS>=8\r\n\r\n               -  Detectable prostatic enlargement determined by DRE\r\n\r\n               -  Urinary flow between 5 and 15ml/second in a total void volume >=150mL\r\n\r\n               -  Serum PSA level less than 4ng/ml or in between 4-10 ng/ml with percent free PSA\r\n                  >25% or>=4 with cancer excluded by biopsy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Acute retention of urine\r\n\r\n          -  Congestive heart failure, unstable angina, arrhythmia, myocardial infraction\r\n\r\n          -  Prostatic surgery\r\n\r\n          -  Prostatic malignancy\r\n\r\n          -  Gastrointestinal disease\r\n\r\n          -  Renal impairment with serum creatinine >140 umol/l\r\n\r\n          -  Hepatic disorder\r\n      ","sponsor":"Hospital Authority, Hong Kong","sponsor_type":"Other","conditions":"Prostatic Hyperplasia|Adrenergic Alpha-Antagonists","interventions":[{"intervention_type":"Drug","name":"Drug: Saw palmetto and sanmiaoshan capsule"}],"outcomes":[{"outcome_type":"primary","measure":"Differences in IPSS between the study medication and placebo groups","time_frame":"At study enrolment, after six month of study medication or placebo administration, at the end of washout period and after six month of alternative drug treatment"},{"outcome_type":"primary","measure":"Differences in Qmax between the study medication and placebo groups","time_frame":"At study enrolment, after six month of study medication or placebo administration, at the end of washout period and after six month of alternative drug treatment"},{"outcome_type":"secondary","measure":"Differences in IPSS and Qmax at baseline and at the end of treatment drug / placebo treatment","time_frame":"From study enrolment/ after washout period to the end of study medication / placebo administration"},{"outcome_type":"secondary","measure":"Mean urinary flow rate, post-void residual volume, prostate volume, PSA and GHQ score between study medication group and placebo group","time_frame":"At study enrolment, after six month of study medication or placebo administration, at the end of washout period and after six month of alternative drug treatment"},{"outcome_type":"secondary","measure":"Mean urinary flow rate, post-void residual volume, prostate volume, PSA and GHQ score between study medication group and baseline, and placebo group and baseline","time_frame":"From study enrolment/ after washout period to the end of study medication / placebo administration"}]}
{"nct_id":"NCT02959242","start_date":"2006-01-31","enrollment":10000,"brief_title":"Dresden Glaucoma and Treatment Study (DGTS)","official_title":"Dresden Glaucoma and Treatment Study: Analysis to Assure the Quality of Follow-up and Therapy of Glaucoma Patients in a Tertiary University Hospital Glaucoma Service.","primary_completion_date":"2026-12-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2026-12-31","last_update":"2021-02-23","description":"To assure the quality of follow-up and treatment, data of glaucoma patients are stored and evaluated after anonymisation.","other_id":"DGTS","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","population":"Glaucoma patients attending a tertiary University Hospital glaucoma Service.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  manifest glaucoma, ocular Hypertension, glaucoma suspect\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  under 18 years of age, corneal diseases\r\n      ","sponsor":"Technische Universitt Dresden","sponsor_type":"Other","conditions":"Glaucoma|Glaucoma, Open-Angle|Glaucoma, Angle-Closure|Glaucoma, Low Tension","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Follow-up intervals","time_frame":"20 years","description":"To find the best follow-up intervals for glaucoma patients."},{"outcome_type":"secondary","measure":"Assessment of treatment quality","time_frame":"20 years","description":"What is the best treatment option for the individual patient?"},{"outcome_type":"secondary","measure":"Assessment of intraocular pressure-lowering efficacy and number of participants with treatment-related adverse events as assessed by CTCAE v4.0 of glaucoma laser therapy","time_frame":"20 years","description":"Diurnal intraocular pressure, best corrected visual acuity, visual fields"},{"outcome_type":"secondary","measure":"Assessment of intraocular pressure-lowering efficacy and number of participants with treatment-related adverse events as assessed by CTCAE v4.0 of glaucoma laser therapy of glaucoma surgery","time_frame":"20 years","description":"Diurnal intraocular pressure, best corrected visual acuity, visual fields"}]}
{"nct_id":"NCT00355810","start_date":"2006-01-31","phase":"N/A","enrollment":19,"brief_title":"Probiotics for Irritable Bowel Syndrome","official_title":"Lactobacillus Plantarum MF 1298 vs Placebo for Irritable Bowel Syndrome.","primary_completion_date":"2006-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2006-12-31","last_update":"2016-07-19","description":"This randomised, double blind, cross-over study compares the effect (symptoms, fecal bacterial growth, gas production) of three weeks' treatment with lactobacillus plantarum MF 1298 with placebo in patients with irritable bowel syndrome. The results are related to dietary habits, food intolerance and food allergy.","other_id":"REK 4.2005.2284","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Irritable bowel syndrome according to the Rome II criteria\r\n\r\n          -  regular symptoms\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Use of probiotics last three weeks\r\n\r\n          -  pregnancy\r\n\r\n          -  lactation\r\n\r\n          -  co-existing other gastrointestinal disorders\r\n\r\n          -  use of laxatives and antibiotics within last 5 weeks.\r\n      ","sponsor":"Norwegian University of Science and Technology","sponsor_type":"Other","conditions":"Functional Gastrointestinal Disorders|Irritable Bowel Syndrome","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: placebo followed by Lactobacillus plantarum MF 1298","description":"placebo during 3 weeks, washout period 4 weeks, Lactobacillus plantarum MF1298 during 3 weeks"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Lactobacillus plantarum MF1298 followed by placebo","description":"Lactobacillus plantarum MF1298 during 3 weeks, washout period 4 weeks, placebo during 3 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Satisfactory relief of abdominal symptoms","time_frame":"11 weeks","description":"relief of symptoms recorded on diary cards"},{"outcome_type":"secondary","measure":"Graded measurement of abdominal symptoms","time_frame":"11 weeks","description":"IBS sum score"},{"outcome_type":"secondary","measure":"Fecal bacterial count","time_frame":"11 weeks"},{"outcome_type":"secondary","measure":"Abdominal gas","time_frame":"11 weeks"},{"outcome_type":"secondary","measure":"Immunological parameters","time_frame":"11 weeks"}]}
{"nct_id":"NCT00989222","start_date":"2006-01-31","phase":"N/A","enrollment":63,"brief_title":"Volar Plating or External Fixation of Dorsally Displaced Fractures of the Distal Radius?","official_title":"Volar Plating or External Fixation of Dorsally Displaced Fractures of the Distal Radius? A Prospective Randomized Study","primary_completion_date":"2009-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-06-30","last_update":"2009-10-05","description":"Promising results have been reported after volar locked plating of unstable dorsally displaced fractures of the distal radius. It offers stable fixation and early mobilization. The investigators' aim is to test if volar locked plating results in better patient-perceived, objective functional and radiological outcomes compared to the less invasive external fixation that has been the standard operation for decades.","other_id":"2005/4:8","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  An acute unilateral Colles' fracture (AO class A and C1) with a dorsal angulation of\r\n             more than 20 degrees or radial shortening of 4 mm or more, AND\r\n\r\n          -  Patient aged 20-70 years with no previous fracture of either wrist.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Bilateral fractures,\r\n\r\n          -  Other current injury to the upper extremities,\r\n\r\n          -  Dementia, OR\r\n\r\n          -  Severe comminution or too small distal fragment to allow plating.\r\n      ","sponsor":"Danderyd Hospital","sponsor_type":"Other","conditions":"Radius Fractures","interventions":[{"intervention_type":"Procedure","name":"Procedure: closed reduction and external fixation","description":"Fixation of an unstable dorsally displaced fracture of the distal radius with bridging external fixation"},{"intervention_type":"Procedure","name":"Procedure: Internal fixation with a volar locked plate","description":"Open reduction and fixation of a unstable dorsally displaced fracture of the distal radius with a volar locked plate"}],"outcomes":[{"outcome_type":"primary","measure":"PRWE (patient rated wrist evaluation) score","time_frame":"3,6 and 12 months"},{"outcome_type":"secondary","measure":"Objective function (range of movement and grip strength)","time_frame":"3,6 and 12 months"}]}
{"nct_id":"NCT00136604","start_date":"2006-01-22","phase":"Phase 3","enrollment":617,"brief_title":"Response to GSK Biologicals' Tritanrix-HepB/Hib-MenAC Vacc (4th Dose) at 15-24m & Mencevax ACWY at 24-30m","official_title":"Assess Immunogenicity, Safety & Reactogenicity of a 4th Dose of GSK Biologicals' Tritanrix-HepB/Hib-MenAC at 15-24 m & of a Dose of Mencevax ACWY at 24-30 m in Subjects Primed With 3 Doses of Tritanrix-HepB/Hib-MenAC","primary_completion_date":"2006-04-23","study_type":"Interventional","rec_status":"Completed","completion_date":"2006-04-23","last_update":"2020-02-20","description":"The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of DTPw-HBV/Hib-MenAC compared to DTPw-HBV/Hib given to healthy subjects at 15 to 24 months of age primed with 3 doses of Tritanrix-HepB/Hib-MenAC in study 100480. Antibody persistence will be evaluated at 24 to 30 months. Immunogenicity, safety and reactogenicity of a dose of Mencevax ACWY given at 24 to 30 months will also be evaluated when given to subjects not boosted with a MenA conjugate and/or MenC containing vaccine.","other_id":"104727 (Booster - 15-24 mths)","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":1.16986,"maximum_age":2,"population":"","criteria":"\n        Inclusion criteria:\r\n\r\n          -  Healthy male or female between and including 15 and 24 months of age\r\n\r\n          -  Having participated in the primary vaccination study DTPW-HBV=HIB-MENAC-TT-003 (eTrack\r\n             No. 100480)\r\n\r\n        Exclusion criteria:\r\n\r\n          -  Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus\r\n             influenzae type b (Hib) and/or meningococcal serogroups A and/or C disease not\r\n             foreseen in the protocol, after the date of the study conclusion visit of the primary\r\n             vaccination study DTPW-HBV=HIB-MENAC-TT-003 (eTrack No. 100480).\r\n\r\n          -  History of or known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib\r\n             and/or meningococcal serogroup A or C disease.\r\n\r\n          -  Any confirmed or suspected immunosuppressive or immunodeficient condition.\r\n\r\n          -  A family history of congenital or hereditary immunodeficiency.\r\n\r\n          -  Major congenital defects or serious chronic illness.\r\n\r\n          -  History of any neurologic disorders or seizures including febrile seizures (at least\r\n             two events) in infancy.\r\n      ","sponsor":"GlaxoSmithKline","sponsor_type":"Industry","conditions":"Whole Cell Pertussis|Haemophilus Influenzae Type b|Hepatitis B|Diphtheria|Tetanus|Diphtheria-Tetanus-Pertussis-Hepatitis B-Haemophilus Influenzae Type b-Neisseria Meningitidis Vaccin","interventions":[{"intervention_type":"Biological","name":"Biological: Tritanrix-HepB/Hib-MenAC","description":"Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b meningococcal AC-tetanus toxoid conjugate Vaccine"},{"intervention_type":"Biological","name":"Biological: Mencevax ACWY","description":"GSK Biologicals' Meningococcal serogroups A, C, W135 and Y polysaccharide vaccine"},{"intervention_type":"Biological","name":"Biological: Tritanrix-HepB/Hiberix","description":"Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B Vaccine, Haemophilus influenzae type b conjugate vaccine"},{"intervention_type":"Biological","name":"Biological: Meningitec","description":"Wyeth's MenC CRM197 conjugated vaccine, Meningitec"}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of Subjects With Meningococcal C Serum Bactericidal Assay (SBA-MenC) Antibody Titers Above the Cut-off Value","time_frame":"One month Post-Booster vaccination at 15-24 months of age","description":"Pre-defined assay cut-off value for assessed titers was greater than or equal to (≥) 1:128."},{"outcome_type":"primary","measure":"Percentage of Subjects With SBA-MenA Antibody Titers Above the Cut-off Value","time_frame":"One Month Post-Booster vaccination at 15-24 months of age","description":"Pre-defined assay cut-off value for assessed titers was greater than or equal to (≥) 1:128. Note: For the MenA antibodies with assay on SBA, additional testing were done using a serogroup A strain 3125 (L10 immunotype)."},{"outcome_type":"primary","measure":"Percentage of Seroprotected (SPR) Subjects With Anti-Polyribosyl Ribitol Phosphate Anti-(PRP) Antibody Concentrations Above the Cut-off Value","time_frame":"One Month Post-Booster vaccination at 15-24 months of age","description":"Antibody concentrations cut-off value was ≥ 1 microgram per milliliter (µg/mL)."},{"outcome_type":"secondary","measure":"Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values","time_frame":"Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age","description":"Antibody concentrations cut-off values were ≥ 0.15 and ≥ 1 micrograms per milliliter (µg/mL)."},{"outcome_type":"secondary","measure":"Anti-PRP Antibody Concentrations","time_frame":"Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age","description":"Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL)."},{"outcome_type":"secondary","measure":"Percentage of Subjects With SBA-MenC Antibody Titers Above the Cut-off Values","time_frame":"Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age","description":"Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:8 and ≥ 1:128."},{"outcome_type":"secondary","measure":"Anti-SBA-MenC Antibody Titers","time_frame":"Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age","description":"Antibody titers were presented as geometric mean titers (GMTs)."},{"outcome_type":"secondary","measure":"Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values","time_frame":"Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age","description":"Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:8 and (≥) 1:128. Note: For the MenA antibodies with assay on SBA, additional testing were done using a serogroup A strain 3125 (L10 immunotype)."},{"outcome_type":"secondary","measure":"Anti-rSBA-MenA Antibody Titers","time_frame":"Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age","description":"Antibody titers were presented as geometric mean titers (GMTs)."},{"outcome_type":"secondary","measure":"Percentage of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above the Predefined Cut-off Values","time_frame":"Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age","description":"Antibody concentrations cut-off values were ≥ 0.3 and ≥ 2 micrograms per milliliter (µg/mL)."},{"outcome_type":"secondary","measure":"Anti-PSC Antibody Concentrations","time_frame":"Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age","description":"Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in micrograms/milliliter (µg/ml)."},{"outcome_type":"secondary","measure":"Percentage of Subjects With Anti-polysaccharide A (Anti-PSA) Antibody Concentrations Above the Predefined Cut-off Values","time_frame":"Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age","description":"Antibody concentrations cut-off values were ≥ 0.3 and ≥ 2 micrograms per milliliter (µg/mL)."},{"outcome_type":"secondary","measure":"Anti-PSA Antibody Concentrations","time_frame":"Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age","description":"Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) ad expressed in micrograms per milliliter ()."},{"outcome_type":"secondary","measure":"Percentage of Seroprotected (SPR) Subjects With Anti-diphtheria Toxoid (Anti-DT) Antibody Concentrations Above the Predefined Cut-off Values","time_frame":"One month after (POST) the Booster vaccination at 15-24 months of age","description":"Antibody concentrations cut-off values were ≥ 0.1 international units per milliliter (IU/mL) as assessed by enzyme-linked immunosorbent assay (ELISA) or ≥ 0.016 IU/ml as assessed by Vero cell neutralization test if concentrations were < 0.1 IU/ml when assessed by ELISA."},{"outcome_type":"secondary","measure":"Anti-D Antibody Concentrations","time_frame":"Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age","description":"Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in international units per milliliter (IU/mL)."},{"outcome_type":"secondary","measure":"Percentage of Seroprotected (SPR) Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Above the Predefined Cut-off Values","time_frame":"Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age","description":"Antibody concentrations cut-off value was ≥ 0.1 international units per milliliter (IU/mL)."},{"outcome_type":"secondary","measure":"Anti-TT Antibody Concentrations","time_frame":"Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age","description":"Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in international units per milliliter (IU/mL)."},{"outcome_type":"secondary","measure":"Percentage of Seroprotected (SPR) Subjects With Anti-Bordetella Pertussis Toxoid (Anti-BPT) Antibody Concentrations Above the Predefined Cut-off Value","time_frame":"One month Post-Booster vaccination","description":"Antibody concentrations cut-off value was ≥ 15 ELISA units per milliliter (EL.U/mL)."},{"outcome_type":"secondary","measure":"Anti-BPT Antibody Concentrations","time_frame":"Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age","description":"Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL)."},{"outcome_type":"secondary","measure":"Percentage of Seroprotected (SPR) Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above the Predefined Cut-off Value","time_frame":"Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age","description":"Antibody concentrations cut-off value was ≥ 10 international units per milliliter (IU/mL)."},{"outcome_type":"secondary","measure":"Anti-HBs Antibody Concentrations","time_frame":"Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age","description":"Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL)."},{"outcome_type":"secondary","measure":"Number of Subjects With Any and Grade 3 Solicited Local Symptoms","time_frame":"During the 4-day (Day 0 to Day 3) post-vaccination period","description":"Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site."},{"outcome_type":"secondary","measure":"Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms","time_frame":"During the 4-day (Days 0-3) post-vaccination period","description":"Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, fever [defined as axillary temperature equal to or above 38.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination."},{"outcome_type":"secondary","measure":"Number of Subjects With Any Unsolicited Adverse Events (AEs)","time_frame":"During the 31-day (Days 0-30) post-vaccination period","description":"An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination."},{"outcome_type":"secondary","measure":"Number of Subjects With Serious Adverse Events (SAEs)","time_frame":"Up to one month Post-Booster vaccination","description":"Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity."}]}
{"nct_id":"NCT00261846","start_date":"2006-01-18","phase":"Phase 2","enrollment":571,"brief_title":"Study Evaluating SKI-606 (Bosutinib) In Philadelphia Chromosome Positive Leukemias","official_title":"A Phase 1/2 Study Of Bosutinib (Ski-606) In Philadelphia Chromosome Positive Leukemias","primary_completion_date":"2009-09-25","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-08-06","last_update":"2017-07-27","description":"This is an open-label, continuous daily dosing, two-part safety and efficacy study of SKI-606 (bosutinib) in Philadelphia chromosome positive leukemias (Ph+). Part 1 is a dose-escalation study in chronic phase Chronic Myelogenous Leukemia (CML) subjects to establish the maximum tolerated dose (MTD) in this subject population. Part 2 has begun after the completion of Part 1 and after a dose has been established for the compound in chronic phase subjects. Part 2 is a study of the the efficacy of 500mg daily oral SKI-606 (bosutinib) in patients with all phases of Ph+ CML and Ph+ Acute Lymphocytic Leukemia (ALL). The protocol will test the hypotheses that oral daily dosing of bosutinib at 500 mg will attain (1) Major Cytogenetic Response (MCyR) in chronic phase CML patients and (2) Overall Hematological Response (OHR) in advanced leukemia patients. Each phase of the disease will be evaluated as a separate cohort.","other_id":"3160A4-200","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Ph+ CML or Ph+ ALL who are primarily refractory to full-dose imatinib (600 mg), have\r\n             disease progression/relapse while on full-dose imatinib, or are intolerant of any dose\r\n             of imatinib.\r\n\r\n          -  At least 3 months post stem cell transplantation\r\n\r\n          -  Able to take daily oral capsules/tablets reliably\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subjects with Philadelphia chromosome, and bcr-abl negative CML\r\n\r\n          -  Overt leptomeningeal leukemia\r\n\r\n          -  Subjects without evidence of leukemia in bone marrow (extramedullary disease only)\r\n      ","sponsor":"Pfizer","sponsor_type":"Industry","conditions":"Chronic Myeloid Leukemia","interventions":[{"intervention_type":"Drug","name":"Drug: Bosutinib","description":"Part 1, starting dose 400 mg oral, daily dosing in the dose-escalation component.\r\nPart 2, 500 mg oral, continuous, daily dosing."}],"outcomes":[{"outcome_type":"primary","measure":"Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 1","time_frame":"0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1"},{"outcome_type":"primary","measure":"Plasma Decay Half-Life (t1/2) - Part 1","time_frame":"0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1","description":"Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.\r\nNA = not estimable."},{"outcome_type":"primary","measure":"Maximum Tolerated Dose (MTD)","time_frame":"Part 1 Baseline up to Day 28","description":"MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced DLT. DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1).\r\nNA = not estimable."},{"outcome_type":"primary","measure":"Number of Participants With Dose Limiting Toxicity (DLT)","time_frame":"Part 1 Baseline up to Day 28","description":"DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1)."},{"outcome_type":"primary","measure":"Maximum Observed Plasma Concentration (Cmax) - Part 1","time_frame":"0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1"},{"outcome_type":"primary","measure":"Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC(0-48)] - Part 1","time_frame":"0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1","description":"AUC(0-48)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-48)."},{"outcome_type":"primary","measure":"Area Under the Concentration-Time Curve (AUC) - Part 1","time_frame":"0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1","description":"AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.\r\nNA = not estimable."},{"outcome_type":"primary","measure":"Apparent Oral Clearance (CL/F) - Part 1","time_frame":"0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1","description":"Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.\r\nNA = not estimable."},{"outcome_type":"primary","measure":"Apparent Volume of Distribution (Vz/F) - Part 1","time_frame":"0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1","description":"Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed."},{"outcome_type":"primary","measure":"Maximum Observed Plasma Concentration at Steady State (Cmax,ss) - Part 1","time_frame":"0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15","description":"Maximum plasma concentration over 24 hours at steady state (ss), on Day 15."},{"outcome_type":"primary","measure":"Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax,ss) - Part 1","time_frame":"0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15","description":"Time to reach maximum observed plasma concentration over 24 hours at steady state (ss), on Day 15."},{"outcome_type":"primary","measure":"Plasma Decay Half-Life at Steady State (t1/2,ss) - Part 1","time_frame":"0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15","description":"Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Plasma decay half-life over 24 hours at steady state (ss), on Day 15 was calculated."},{"outcome_type":"primary","measure":"Area Under the Concentration-Time Curve at Steady State (AUCss) - Part 1","time_frame":"0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15","description":"AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. AUC over 24 hours at steady state (ss), on Day 15 was calculated."},{"outcome_type":"primary","measure":"Apparent Oral Clearance at Steady State (CL/F,ss) - Part 1","time_frame":"0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15","description":"Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Apparent oral clearence over 24 hours at steady state (ss), on Day 15 was calculated."},{"outcome_type":"primary","measure":"Accumulation Ratio (R)","time_frame":"0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 1 and Day 15","description":"R=accumulation ratio (AUCss on Day 15/AUC0-24 on Day 1)"},{"outcome_type":"primary","measure":"Percentage of Participants With MCyR at Week 24 in Chronic Phase Second-line Imatinib Resistant CML Population - Part 2","time_frame":"Week 24","description":"CyR is based on the prevalence of Ph+ cells. Major cytogenetic response was categorized as either CCyR or partial CyR (PCyR). CCyR was achieved when there was 0 percent (%) Ph+ cells from at least 20 metaphases from conventional bone marrow cytogenetics or less than (<) 1% positive cells from at least 200 cells analyzed from fluorescent in situ hybridization (FISH). PCyR was achieved when 1 to 35% Ph+ cells were present."},{"outcome_type":"secondary","measure":"Percentage of Participants With Major Cytogenetic Response (MCyR) - Part 1","time_frame":"Weeks 12, 24, 36, 48 and the end of active treatment phase of Part 1 (Week 52)","description":"Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells. Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was 0% Ph+ cells from at least 20 metaphases from conventional bone marrow cytogenetics or <1% positive cells from at least 200 cells analyzed from FISH. PCyR was achieved when 1 to 35% Ph+ cells were present."},{"outcome_type":"secondary","measure":"Phosphorylation Inhibition of Breakpoint Cluster Region-Abelson Kinase (Bcr-Abl) - Part 1","time_frame":"Baseline, Weeks 4, 8, 12, 24, 36, 48 and the end of the active treatment phase of Part 1 (Week 52)","description":"bcr-Abl is a protein resulting from the transcription of the Philadelphia chromosome following 9:22 chromosomal translocation, and phosphorylation inhibition of which correlates with inhibition of tumor cell growth."},{"outcome_type":"secondary","measure":"Phosphorylation Inhibition of Crk Like (CrkL) Protein at Baseline - Part 1","time_frame":"0 (pre-dose) on Day 1 (Baseline)","description":"CrkL is a protein, phosphorylation of which has been shown to correlate with CML cell growth; and conversely inhibition of their phosphorylation correlates with inhibition of tumor cell growth. Phosphorylation of CrkL was monitored in whole blood cells, as well as in the cluster of differentiation 3 (CD3+) (T cell), CD19+ (B cell) and CD34+ (blast cell) compartments by using fluorescent activated cell sorter (FACS) flow cytometry."},{"outcome_type":"secondary","measure":"Progression Free Survival (PFS) - Part 2","time_frame":"Years 1, 2, 3, 4, and 5 (CP2L only)","description":"PFS was based on Kaplan-Meier method. Disease progression was determined by the investigator as the reason for treatment discontinuation and death was due to any cause within 30 days of last dose. Duration in months = (date of PD/death or last valid cytogenetic/hematologic assessment if censored - first dose date)/30.4.\r\nNA = not estimable. One year = 12 months"},{"outcome_type":"secondary","measure":"Percent Change From Baseline in Phosphorylation Inhibition of Crk Like Protein (CrkL) at Day 1, 8 and 15 - Part 1","time_frame":"6 hours post-dose on Day 1, 0 (pre-dose), 6 hours post-dose on Day 8, 15","description":"CrkL is a protein, phosphorylation of which has been shown to correlate with CML cell growth; and conversely inhibition of their phosphorylation correlates with inhibition of tumor cell growth. Phosphorylation of CrkL was monitored in whole blood cells, as well as in the CD3+ (T cell), CD19+ (B cell) and CD34+ (blast cell) compartments by using FACS flow cytometry.\r\nNA = not estimable."},{"outcome_type":"secondary","measure":"Percentage of Participants With Major Cytogenetic Response (MCyR) in Chronic Phase Second-line and Chronic Phase Third-line CML Population - Part 2","time_frame":"Week 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 4 (CP3L) or Year 5 (CP2L)","description":"CyR is based on the prevalence of Ph+ cells. MCyR was categorized as either CCyR or PCyR. CCyR was achieved when there was 0% Ph+ cells from at least 20 metaphases from conventional bone marrow cytogenetics or <1% positive cells from at least 200 cells analyzed from FISH. PCyR was achieved when 1 to 35% Ph+ cells were present."},{"outcome_type":"secondary","measure":"Kaplan-Meier Estimate of Retaining an Attained/Maintained Major Cytogenetic Response (MCyR) at Year 5 in Chronic Phase Second-line CML - Part 2","time_frame":"From first MCyR to loss of MCyR or censoring, assessed every 12 weeks up to 2 years and then every 24 weeks thereafter up to Year 5","description":"MCyR was categorized as either CCyR or PCyR. CCyR was achieved when there was 0% Ph+ cells from at least 20 metaphases from conventional bone marrow cytogenetics or <1% positive cells from at least 200 cells analyzed from FISH. PCyR was achieved when 1 to 35% Ph+ cells were present. The Kaplan-Meier probability of retaining an attained/maintained MCyR at Year 5 is reported. Median durations were not reached as of the minimum follow-up. Duration of response in weeks =(date of confirmed loss of first attained response or last valid cytogenetic assessment for those censored - date of first attained response)/7."},{"outcome_type":"secondary","measure":"Time to Achieve Major Cytogenetic Response (MCyR) in Chronic Phase Second-line CML for Responders Only - Part 2","time_frame":"Week 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 5","description":"MCyR was categorized as either CCyR or PCyR. CCyR was achieved when there was 0% Ph+ cells from at least 20 metaphases from conventional bone marrow cytogenetics or <1% positive cells from at least 200 cells analyzed from FISH. PCyR was achieved when 1 to 35% Ph+ cells were present. Time to MCyR was the interval from the date of first dose of study medication until the first date of achieving a given response.\r\nTime to response in weeks equals (=) (event date minus (-) first dose date plus (+) 1)divided (/)7, where the event date is the non-missing date of the first attained response for responders only."},{"outcome_type":"secondary","measure":"Kaplan-Meier Estimate of Maintaining Complete Hematologic Response (CHR) at Year 4 (CP3L and ADV) or Year 5 (CP2L) - Part 2","time_frame":"From date of first confirmed CHR to loss of CHR or censoring, assessed at Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 4 (CP3L and ADV) or Year 5 (CP2L)","description":"Hematologic response: if participants met all of the following criteria of CHR: White Blood Cells equal to or less than (≤) institutional upper limit of normal, no peripheral blood blasts or promyelocytes, myelocytes+metamyelocytes <5% in blood, absolute neutrophil count greater than or equal to (≥) 1.0×10^9 per liter (/L) , platelets ≥100×10^9/L & <450×10^9/L, <20% basophils in blood & no extramedually involvement (including hepato- or splenomegaly), ≤5% BM blasts (ADV only & applicable to CP if BM aspirate was performed). The duration of CHR was defined as the interval from the first date of response until the first date of confirmed loss of response. Duration of response in weeks =(date of confirmed loss of attained response or last valid hematologic assessment for those censored - date of first confirmed response)/7. The Kaplan-Meier estimate of maintaining CHR at the end of minimum follow-up is presented (CP2L: Year 5; CP3L & ADV: Year 4). NA = not estimable.\r\nNA = not estimable."},{"outcome_type":"secondary","measure":"Duration of Complete Hematologic Response (CHR) - Part 2","time_frame":"From date of first confirmed CHR to loss of CHR or censoring, assessed at Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 4 (CP3L and ADV) or Year 5 (CP2L)","description":"Hematologic response: if participants met all of the following criteria of CHR: White Blood Cells equal to or less than (≤) institutional upper limit of normal, no peripheral blood blasts or promyelocytes, myelocytes+metamyelocytes less than (<)5% in blood, absolute neutrophil count greater than or equal to (≥) 1.0×10^9 per liter (/L) , platelets <450×10^9/L, platelets ≥100×10^9/L, <20% basophils in blood and no extramedually involvement (including hepato- or splenomegaly), ≤5% BM blasts (required for ADV only and applicable to CP if BM aspirate was performed). The duration of CHR was defined as the interval from the first date of response until the first date of confirmed loss of response. Duration of response in weeks =(date of confirmed loss of attained response or last valid hematologic assessment for those censored - date of first confirmed response)/7.\r\nNA = not estimable."},{"outcome_type":"secondary","measure":"Time to Achieve Complete Hematologic Response (CHR) for Responders Only - Part 2","time_frame":"Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 4 (CP3L and ADV) or Year 5 (CP2L)","description":"The time to CHR was measured from the date of first dosing to the first date of response. Time to response in weeks = (event date - first dose date plus 1)/7, where the event date is the non-missing date of the first attained response for responders only."},{"outcome_type":"secondary","measure":"Cumulative Incidence of Progression/Death - Part 2","time_frame":"Years 1, 2, 3, 4, and 5 (CP2L only)","description":"The cumulative incidence of on-treatment progression or death adjusting for the competing risk of treatment discontinuation without the event. Disease progression was determined by the investigator as the reason for treatment discontinuation and death was due to any cause within 30 days of last dose. Duration in months = (date of PD/death or last valid cytogenetic/hematologic assessment if censored - first dose date)/30.4. 95% confidence intervals were calculated using Gray's method.\r\nNA = not estimable. One year = 12 months."},{"outcome_type":"secondary","measure":"Kaplan-Meier Estimate of Overall Survival (OS) - Part 2","time_frame":"Years 1, 2, 3, 4, and 5 (CP2L only)","description":"OS was based on Kaplan-Meier method. Survival was defined as the time period from the date of first dose of bosutinib to the date of death or date of last contact for those censored.\r\nNA = not estimable. One year = 12 months."},{"outcome_type":"secondary","measure":"Overall Survival (OS) - Part 2","time_frame":"Years 1, 2, 3, 4, and 5 (CP2L only)","description":"OS was based on Kaplan-Meier method. Survival was defined as the time period from the date of first dose of bosutinib to the date of death or date of last contact for those censored.\r\nNA = not estimable. One year = 12 months."},{"outcome_type":"secondary","measure":"Percentage of Participants With Confirmed Complete Hematologic Response (CHR) - Part 2","time_frame":"Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 4 (CP3L and ADV) or Year 5 (CP2L)","description":"Hematologic response: if participants met all of the following criteria of CHR: White Blood Cells ≤ institutional upper limit of normal, no peripheral blood blasts or promyelocytes, myelocytes+metamyelocytes <5% in blood, absolute neutrophil count ≥ 1.0×10^9/L , platelets <450×10^9/L, platelets ≥100×10^9/L, <20% basophils in blood and no extramedually involvement (including hepato- or splenomegaly), ≤5% BM blasts (required for ADV only and applicable to CP if BM aspirate was performed)."},{"outcome_type":"secondary","measure":"Percentage of Participants With Overall Hematologic Response (OHR) by Week 48 in Advanced Leukemia Population - Part 2","time_frame":"Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 1 year","description":"OHR included CHR, no evidence of leukemia (≤5% bone marrow blasts, no peripheral blood blasts or promyelocytes, <5% myelocytes + metamyelocytes in blood, white blood cells ≤ institutional upper limit of normal, 450x10^9/L > platelets > 20x10^9/L, absolute neutrophil count ≥0.5x10^9/L, <20% basophils in blood, no extramedullary involvement [including liver or spleen]), minor hematologic response (acute lymphoblastic leukemia [ALL] patients only, defined as <15% blasts in marrow & blood, <30% blasts + promyelocytes in marrow & blood, <20% basophils in peripheral blood & no extramedullary disease other than spleen & liver) or return to chronic phase (AP/BP participants, defined as <15% blasts in both peripheral blood &bone marrow, <30% blasts + promyelocytes in both peripheral blood & bone marrow, <20% basophils in both peripheral blood & bone marrow, no extramedullary Involvement other than liver or spleen). Participants had to meet at least 1 criterion."},{"outcome_type":"secondary","measure":"Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)","time_frame":"Baseline up to follow up visit (30 days after last dose of study treatment)","description":"An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state."},{"outcome_type":"secondary","measure":"Duration of Potentially Clinically Important (PCI) Adverse Events (AEs)","time_frame":"Baseline up to follow-up visit (30 days after last dose of study treatment)","description":"An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. The event did not necessarily have a causal relationship with the treatment. PCI AEs included anemia, alanine aminotranferase (ALT), aspartate aminotransferase (AST), cardiac, diarrhea, edema, effusion, gastrointestinal, hemorrhage, hypersensitivity, hypertension, infection, liver, myelosuppression, nausea, neutropenia, rash, renal, thrombocytopenia, vomiting, and vascular events. Duration of AE was calculated as (stop date minus start date) plus 1 for non-missing and non-partial dates.\r\nNA = not estimable."},{"outcome_type":"secondary","measure":"Percentage of Participants With Change From Baseline in Laboratory Tests Results","time_frame":"Week 1, 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter","description":"Laboratory assessments included urinalysis, complete blood count (CBC), prothrombin time/partial prothromboplastin time (PT/PPT), international normalized ratio (INR), blood chemistry and serum pregnancy test (β-HCG). Parameters of special interest included liver function tests and those related to myelosuppression. Potentially clinically important (PCI) laboratory values were defined as National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0) grade 3 or higher. Maximum CTCAE grade, and only participants who shifted to Grade 3/4 on-treatment, are reported."},{"outcome_type":"secondary","measure":"Percentage of Participants With On-treatment PCI Change From Baseline in Electrocardiogram (ECG) Findings","time_frame":"Baseline, 0 (pre-dose), 2, 4, 6 hours on Day 1, 0 (pre-dose), 2, 4, 6, 20-23 hours on Day 21, and end of treatment visit","description":"Criteria for PCI changes in ECG (12-lead) were defined as: no sinus rhythm; PR interval >=220 msec and increase of >=20 msec; QRS interval >=120 msec; QT interval corrected using the Fridericia formula (QTcF) and QT interval corrected using the Bazett formula (QTcB) >500 msec or increase of >60 msec; heart rate <=45 beats per minute (bpm) or >=120 bpm or decrease/increase of >=15 bpm."},{"outcome_type":"secondary","measure":"Number of Participants With Change From Baseline in Findings of Chest X-ray","time_frame":"Baseline, Week 8, and end of treatment","description":"Number of participants whose chest X-ray results changed (worsened or improved) from the Baseline."},{"outcome_type":"secondary","measure":"Number of Participants Who Received Concomitant Medications for Management of Adverse Events (AEs)","time_frame":"Baseline and Weeks 1, 2, 3, 4, 8, 12, then every 12 weeks thereafter until end of treatment, for a mean duration of 28 months","description":"Number of participants taking any non-study medications which were administered from Study Day 1 to 30 days after last dose of study treatment as a management of an AE are reported."},{"outcome_type":"secondary","measure":"Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS)","time_frame":"Baseline, Week 1, 2, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter","description":"ECOG-PS measured on-therapy (time between first dose and last dose date with a 30-day lag) assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction;1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work;2=ambulatory (>50% of waking hrs), capable of all self care, unable to carry out any work activities;3=capable of only limited self care, confined to bed/chair >50% of waking hrs;4=completely disabled, cannot carry on any self care, totally confined to bed/chair;5=dead."},{"outcome_type":"secondary","measure":"Percentage of Participants With Change From Baseline in Physical Examinations and Vital Signs","time_frame":"Screening, Baseline, and end of treatment","description":"Percentage of participants with PCI physical examinations and vital signs is reported during therapy and at post therapy. Criteria for PCI change in vital signs: heart rate value of <40 beats per min and value >150 beats per min, systolic blood pressure (SBP) of <80 or >210 millimeter of mercury (mmHg), diastolic blood pressure (DBP) of <40 or >130 mmHg, temperature <32 or >40 degree centigrade, respiratory rate (Resp) of <10 or >50 breaths/min and criteria for PCI change in physical examination: >=10% increase or decrease of body weight in kilogram (kg)."},{"outcome_type":"secondary","measure":"Percentage of Participants With Change From Baseline in Physical Examinations and Vital Signs and Number of Participants With PCI Values","time_frame":"Post-therapy","description":"Percentage of participants with PCI physical examinations and vital signs is reported during therapy and at post therapy. Criteria for PCI change in vital signs: heart rate value of <40 beats per min and value >150 beats per min, SBP of <80 or >210 mmHg, DBP of <40 or >130 mmHg, temperature <32 or >40 degree centigrade, Resp of <10 or >50 breaths/min and criteria for PCI change in physical examination: >=10% increase or decrease of body weight in kg. No Ph+ ALL participants were analyzed post-therapy (N=0). Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results."}]}
{"nct_id":"NCT00276185","start_date":"2005-12-31","phase":"Phase 3","enrollment":180,"brief_title":"HEMITOX : Effect of Botulinum Toxin Injections on Motor and Functional Ability of Upper Limb in Adults at Earlier Phases of Spastic Hemiplegia After Stroke","official_title":"Effect of Botulinum Toxin Injections on Motor and Functional Ability of Upper Limb in Adults at Earlier Phases of Spastic Hemiplegia After Stroke","primary_completion_date":"2009-01-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2009-12-31","last_update":"2011-01-19","description":"Botulinum toxin produced beneficial effects in spasticity in the hemiplegic upper limb. This study will test if botulinum toxin injections at earlier phases (<or = 3 months) in spasticity improve functional and motor tests compared with late injections (>or = 6 months).","other_id":"CHU63-0003","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Minimum age 18\r\n\r\n          -  Spastic hemiplegia after ischemic stroke (carotid occlusion) within the past 3 months.\r\n\r\n          -  Antispasticity medication stabilized for the last 30 days\r\n\r\n          -  Severe cognitive impairment such that patient is unable to provide scale assessment.\r\n\r\n          -  Significant spasticity impeding improvement by re-education for 2 months or less\r\n\r\n          -  Lack of muscular retraction defined by a minimal range of articular motion as :\r\n\r\n               -  finger : complete extension and rolling up\r\n\r\n               -  wrist : extension 40/flexion : 45\r\n\r\n               -  elbow : extension - 10/flexion : 120\r\n\r\n               -  shoulder : Enjalbert score 2 or more\r\n\r\n          -  Antagonist muscles (to spasticity) activity score 1 or more\r\n\r\n          -  Social Security benefits\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Ischemic stroke thought to be due to basilar or vertebral vessel occlusion\r\n\r\n          -  Known motor neuron or neuromuscular junction disease, disorders in which pain limits\r\n             the ability to inject muscles (algodystrophy)\r\n\r\n          -  Absence of mobility in proximal part of upper limb that does not predict a functional\r\n             gain\r\n\r\n          -  Minor stroke with non-disabling deficit or rapidly improving motor symptoms\r\n\r\n          -  other serious illness, e.g. severe hepatic, cardiac, or renal failure ; acute\r\n             myocardial infarction ; or a complex disease that may confound treatment assessment\r\n\r\n          -  Treatment of spasticity by previous administration of botulinum toxin, if known\r\n\r\n          -  Known allergy to botulinum toxin\r\n\r\n          -  Currently participating in other research studies\r\n      ","sponsor":"University Hospital, Clermont-Ferrand","sponsor_type":"Other","conditions":"Hemiplegia","interventions":[{"intervention_type":"Drug","name":"Drug: Time delay treatment of botulinum toxin"}],"outcomes":[{"outcome_type":"primary","measure":"Deficiency, incapacity, handicap : Frenchay Arm test(post stroke arm function); Enjalbert test;"},{"outcome_type":"primary","measure":"Box and blocks test"},{"outcome_type":"primary","measure":"Enjalbert test"},{"outcome_type":"primary","measure":"Modified Ashworth scale (upper limb)"},{"outcome_type":"primary","measure":"Functional Independence Measure"},{"outcome_type":"primary","measure":"Fugl-Meyer upper limb test"},{"outcome_type":"primary","measure":"Clinical Global Impression (CGI)"},{"outcome_type":"primary","measure":"36-Item Short Form (SF-36) quality of life"},{"outcome_type":"secondary","measure":"Range of pain"},{"outcome_type":"secondary","measure":"Individual functional kinesitherapy"}]}
{"nct_id":"NCT00258869","start_date":"2005-12-31","enrollment":1200,"brief_title":"Observational Study of Sepsis and Pneumonia to Develop Diagnostic Tests","official_title":"Plasma Protein Biomarker Based Diagnostics of Outcome in Sepsis & CAP","primary_completion_date":"2010-07-31","study_type":"Observational","rec_status":"Unknown status","completion_date":"2010-07-31","last_update":"2010-11-09","description":"We propose to develop novel diagnostic tests for severe sepsis and community acquired pneumonia (CAP). This program, entitled Community Acquired Pneumonia & Sepsis Outcome Diagnostics (CAPSOD), is a multidisciplinary collaboration involving investigators at six organizations: NCGR; Duke University Medical Center, Durham, NC; Henry Ford Hospital, Detroit, MI; Eli Lilly and Company, Indianapolis, IN; Indiana Centers for Applied Protein Sciences, Indianapolis, IN; and ProSanos Corp., La Jolla, CA. In the United States, Community Acquired Pneumonia is the sixth leading cause of death and the number one cause of death from infectious diseases. Of the 5.6 million annual cases of CAP, 1.1 million require hospitalization for intensive therapy. Sepsis, commonly known as blood poisoning or bloodstream infection, is the tenth leading cause of death in the US and the number one cause of death in non-cardiac intensive care units. Incidence of sepsis is increasing by 9% each year and mortality rates vary between 25 and 50%. Cost to the US healthcare system exceeds $20 billion each year. In patients with suspected sepsis or early CAP, rapid identification of patients who will develop severe sepsis or CAP is critical for effective management and positive outcome. The CAPSOD study is designed to identify novel tests for early diagnosis of severe sepsis and CAP. When performed in patients at the earliest stages of disease, these tests will have prognostic value, rapidly identifying those who will have poor outcomes or complicated courses. CAPSOD will prospectively enroll patients with sepsis and CAP at Duke University Medical Center and Henry Ford Hospital. The study will use advanced bioinformatic, metabolomic, proteomic and mRNA sequencing technologies to identify specific protein changes, or biomarkers, in patient blood samples that predict outcome in sepsis and CAP. Development of biomarker-based tests will permit patient selection for appropriate disposition, such as the intensive care unit, and use of intensive medical therapies, thereby reducing mortality and increasing effectiveness of resource allocation.","other_id":"0001","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":6,"population":"Emergency department patients > 6 years of age","criteria":"\n        Inclusion Criteria:\r\n\r\n        1. Patient has known or acute infection or suspected infection AND patient must meet at\r\n        least 2 of the following 4 criteria to be enrolled\r\n\r\n          1. A core temperature of >= 38C (100.4F) or <= 36C (96.8F)\r\n\r\n          2. Patients > 18 years of age, Heart rate of >= 90 beats/min Patients 13-18 years of age,\r\n             Heart rate of >= 110 beats/min Patients 6-12 years of age, Heart rate of >= 130\r\n             beats/min\r\n\r\n          3. Patients > 18 years of age, Respiratory rate of >= 20 breaths/min Patients 13-18 years\r\n             of age, Respiratory rate of >= 14 breaths/min Patients 6-12 years of age, Respiratory\r\n             rate of >= 18 breaths/min OR PaCO2 of <= 32 mm Hg OR Use of Mechanical Ventilation for\r\n             an acute respiratory process\r\n\r\n          4. Patients > 18 years of age, White cell count >= 12,000/mm3 or <= 4,000/mm3 Patients\r\n             13-18 years of age, White cell count >= 11,000/mm3 or <= 4,500/mm3 Patients 6-12 years\r\n             of age, White cell count >= 13,500/mm3 or <= 4,500/mm3 OR A differential count showing\r\n             > 10% immature neutrophils\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patient is less than 6 years of age.\r\n\r\n          2. Patient is not expected to survive 28 days because of uncorrectable medical condition\r\n             (apart from pneumonia or sepsis), such as poorly controlled neoplasm or other\r\n             end-stage disease, or patient has active DNR order\r\n\r\n          3. Human immunodeficiency virus (HIV) infection with a last known CD4 count of <50 mm3\r\n\r\n          4. Acute presence of a cerebral vascular event, active gastrointestinal hemorrhage,\r\n             seizure (acute episode), drug overdose, burn injury, trauma\r\n\r\n          5. Patient is pregnant\r\n      ","sponsor":"National Center for Genome Resources","sponsor_type":"Other","conditions":"Sepsis|Septicemia|Sepsis Syndrome|Shock, Septic|Community Acquired Pneumonia","interventions":{},"outcomes":[{"outcome_type":"secondary","measure":"Time to coagulation SOFA score","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Time to liver SOFA score","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Time to CVS SOFA score","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Time to Renal SOFA score","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Time to ALI","time_frame":"Days"},{"outcome_type":"secondary","measure":"DIC score >5 (modified ISTH scoring system)","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Time to DIC score > 5","time_frame":"Days"},{"outcome_type":"secondary","measure":"Development of ALI","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Development of ARDS","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Cryptic shock (ScvO2<65 or Lactate >2.5 and MAP >65 mmHg [>18 years of age] or SBP >90 [<18 years of age])","time_frame":"Day 5"},{"outcome_type":"secondary","measure":"Cryptic shock (ScvO2<65 or Lactate >2.5 and MAP >65 mmHg [>18 years of age] or SBP >90 [<18 years of age])","time_frame":"Day 7"},{"outcome_type":"secondary","measure":"Liver SOFA score","time_frame":"28 days"},{"outcome_type":"secondary","measure":"CVS SOFA score","time_frame":"28 dadys"},{"outcome_type":"secondary","measure":"Time to respiratory SOFA Score","time_frame":"28 days"},{"outcome_type":"primary","measure":"Death","time_frame":"Day 3"},{"outcome_type":"primary","measure":"Septic Shock","time_frame":"Day 3"},{"outcome_type":"primary","measure":"Severe Sepsis","time_frame":"Day 3"},{"outcome_type":"secondary","measure":"Time to death","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Death","time_frame":"Day 5"},{"outcome_type":"secondary","measure":"Death","time_frame":"Day 7"},{"outcome_type":"secondary","measure":"Death","time_frame":"Day 28"},{"outcome_type":"secondary","measure":"Time to severe sepsis","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Severe sepsis","time_frame":"Day 5"},{"outcome_type":"secondary","measure":"Severe sepsis","time_frame":"Day 7"},{"outcome_type":"secondary","measure":"Severe sepsis","time_frame":"Day 28"},{"outcome_type":"secondary","measure":"Time to septic shock","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Septic Shock","time_frame":"Day 5"},{"outcome_type":"secondary","measure":"Septic Shock","time_frame":"Day 7"},{"outcome_type":"secondary","measure":"Septic shock","time_frame":"Day 28"},{"outcome_type":"secondary","measure":"Cryptic shock (ScvO2<65 or Lactate >2.5 and MAP >65 mmHg [>18 years of age] or SBP >90 [<18 years of age])","time_frame":"Day 3"},{"outcome_type":"secondary","measure":"Time to Cryptic shock (ScvO2<65 or Lactate >2.5 and MAP >65 mmHg [>18 years of age] or SBP >90 [<18 years of age])","time_frame":"Day 28"},{"outcome_type":"secondary","measure":"Cryptic shock (ScvO2<65 or Lactate >2.5 and MAP >65 mmHg [>18 years of age] or SBP >90 [<18 years of age])","time_frame":"Day 28"},{"outcome_type":"secondary","measure":"Hospitalization","time_frame":"24 hours"},{"outcome_type":"secondary","measure":"Length of hospital stay","time_frame":"Days"},{"outcome_type":"secondary","measure":"ICU admission","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Length of ICU admission","time_frame":"Days"},{"outcome_type":"secondary","measure":"Disposition","time_frame":"28 day"},{"outcome_type":"secondary","measure":"Renal dysfunction","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Respiratory dysfunction","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Hematology dysfunction","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Metabolic dysfunction","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Renal SOFA score","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Lung SOFA score","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Coagulation SOFA score","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Time to ARDS","time_frame":"Days"},{"outcome_type":"secondary","measure":"Ventilator","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Ventilator days","time_frame":"Days"},{"outcome_type":"secondary","measure":"MELD score","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Effect of early goal directed therapy on primary and secondary end-points","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Effect of Activated Protein C on primary and secondary end-points","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Effect of stress-dose corticosteroids on primary and secondary end-points","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Effect of intensive glycemic control on primary and secondary end-points","time_frame":"28 days"},{"outcome_type":"secondary","measure":"APACHE II score","time_frame":"enrollment"},{"outcome_type":"secondary","measure":"APACHE II score","time_frame":"24 hours"},{"outcome_type":"secondary","measure":"PRISM III score","time_frame":"enrollment"},{"outcome_type":"secondary","measure":"PRISM III score","time_frame":"24 hours"},{"outcome_type":"secondary","measure":"SOFA score","time_frame":"enrollment"},{"outcome_type":"secondary","measure":"SOFA score","time_frame":"24 hours"},{"outcome_type":"secondary","measure":"CAP mortality","time_frame":"Day 3"},{"outcome_type":"secondary","measure":"CAP and severe sepsis","time_frame":"Day 3"},{"outcome_type":"secondary","measure":"CAP and septic shock","time_frame":"Day 3"},{"outcome_type":"secondary","measure":"Severe CAP (ATS criteria)","time_frame":"Day 3"},{"outcome_type":"secondary","measure":"Severe CAP (BTS criteria)","time_frame":"Day 3"},{"outcome_type":"secondary","measure":"Pneumococcal sepsis","time_frame":"Day 7"},{"outcome_type":"secondary","measure":"Staphylococcus aureus sepsis","time_frame":"Day 7"},{"outcome_type":"secondary","measure":"Gram negative rod sepsis","time_frame":"Day 7"},{"outcome_type":"secondary","measure":"Fungal sepsis","time_frame":"Day 7"},{"outcome_type":"secondary","measure":"SeptiFast result","time_frame":"Enrollment"},{"outcome_type":"secondary","measure":"SeptiFast result","time_frame":"24 hours"},{"outcome_type":"secondary","measure":"Microbiologic culture result","time_frame":"Day 28"},{"outcome_type":"secondary","measure":"Urinary legionella antigen","time_frame":"7 days"},{"outcome_type":"secondary","measure":"Microbiologic culture","time_frame":"7 days"},{"outcome_type":"secondary","measure":"CAP, time to death","time_frame":"days"},{"outcome_type":"secondary","measure":"CAP, mortality","time_frame":"Day 5"},{"outcome_type":"secondary","measure":"CAP, mortality","time_frame":"Day 7"},{"outcome_type":"secondary","measure":"CAP, mortality","time_frame":"Day 28"},{"outcome_type":"secondary","measure":"CAP, time to severe sepsis","time_frame":"Days"},{"outcome_type":"secondary","measure":"CAP, severe sepsis","time_frame":"Day 5"},{"outcome_type":"secondary","measure":"CAP, severe sepsis","time_frame":"Day 7"},{"outcome_type":"secondary","measure":"CAP, severe sepsis","time_frame":"Day 28"},{"outcome_type":"secondary","measure":"CAP, time to septic shock","time_frame":"days"},{"outcome_type":"secondary","measure":"CAP, septic shock","time_frame":"Day 5"},{"outcome_type":"secondary","measure":"CAP, septic shock","time_frame":"Day 7"},{"outcome_type":"secondary","measure":"CAP, septic shock","time_frame":"Day 28"},{"outcome_type":"secondary","measure":"Time to severe CAP (ATS and BTS criteria)","time_frame":"Days"},{"outcome_type":"secondary","measure":"Severe CAP (ATS and BTS criteria)","time_frame":"Day 5"},{"outcome_type":"secondary","measure":"Severe CAP (ATS and BTS criteria)","time_frame":"Day 7"},{"outcome_type":"secondary","measure":"Severe CAP (ATS and BTS criteria)","time_frame":"Day 28"},{"outcome_type":"secondary","measure":"CAP, mechanical ventilation","time_frame":"28 days"},{"outcome_type":"secondary","measure":"CAP, time to mechanical ventilation","time_frame":"Days"},{"outcome_type":"secondary","measure":"CAP, length of mechanical ventilation","time_frame":"Days"},{"outcome_type":"secondary","measure":"CAP, SOFA respiratory score > 2","time_frame":"28 days"},{"outcome_type":"secondary","measure":"CAP, respiratory component of severe sepsis criteria","time_frame":"28 days"},{"outcome_type":"secondary","measure":"CAP, hospitalized","time_frame":"24 hours"},{"outcome_type":"secondary","measure":"CAP, length of hospitalization","time_frame":"Days"},{"outcome_type":"secondary","measure":"CAP, ICU admission","time_frame":"28 days"},{"outcome_type":"secondary","measure":"CAP, length of ICU stay","time_frame":"Days"},{"outcome_type":"secondary","measure":"CAP, Disposition","time_frame":"28 days"},{"outcome_type":"secondary","measure":"CAP, ALI","time_frame":"28 days"},{"outcome_type":"secondary","measure":"CAP, ARDS","time_frame":"28 days"},{"outcome_type":"secondary","measure":"CAP, time to ARDS","time_frame":"days"},{"outcome_type":"secondary","measure":"CAP, time to ALI","time_frame":"Days"},{"outcome_type":"secondary","measure":"CAP, PORT score","time_frame":"enrollment"},{"outcome_type":"secondary","measure":"CAP, PORT score","time_frame":"24 hours"}]}
{"nct_id":"NCT00267683","start_date":"2005-12-31","phase":"Phase 3","enrollment":9,"brief_title":"Efficacy and Safety of Insulin Aspart Versus Glibenclamide in Type 2 Diabetes","official_title":"A Clinical Trial to Study the Efficacy and Safety of Insulin Aspart Three Times Per Day Compared to Glibenclamide Once or Twice Daily in Type 2 Diabetes by Comparison of Ability to Control Blood Glucose","primary_completion_date":"2006-04-30","study_type":"Interventional","rec_status":"Terminated","completion_date":"2006-04-30","last_update":"2016-03-04","description":"This trial is conducted in Japan. This is a clinical trial to study the efficacy and safety of thrice daily Insulin Aspart compared to Glibenclamide in type 2 diabetic patients.","other_id":"ANA-1667","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Type 2 diabetes\r\n\r\n          -  Diet therapy for at least 12 weeks, or diet therapy and oral hypoglycaemic agent(s)\r\n             other than SU agents for at least 12 weeks\r\n\r\n          -  No previous treatment with insulin and/or SU agents\r\n\r\n          -  HbA1c between 7.5% and 10.0%\r\n\r\n          -  Body Mass Index (BMI) below 30.0 kg/m2\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Proliferative retinopathy or maculopathy requiring acute treatment\r\n\r\n          -  Impaired hepatic function\r\n\r\n          -  Impaired renal function\r\n\r\n          -  Cardiac diseases\r\n\r\n          -  Uncontrolled hypertension\r\n\r\n          -  Known hypoglycaemia unawareness or recurrent major hypoglycaemia\r\n\r\n          -  Current treatment with systemic corticosteroids\r\n      ","sponsor":"Novo Nordisk A/S","sponsor_type":"Industry","conditions":"Diabetes|Diabetes Mellitus, Type 2","interventions":[{"intervention_type":"Drug","name":"Drug: insulin aspart"},{"intervention_type":"Drug","name":"Drug: glibenclamide"}],"outcomes":[{"outcome_type":"primary","measure":"HbA1c","time_frame":"after 24 weeks of treatment"},{"outcome_type":"secondary","measure":"Plasma glucose levels"},{"outcome_type":"secondary","measure":"Percentage of subjects achieving the treatment target of HbA1c value < 6.5%"}]}
{"nct_id":"NCT00261313","start_date":"2005-12-31","phase":"Phase 2","enrollment":80,"brief_title":"ACCELERATE: Doxorubicin and Cyclophosphamide Followed by Paclitaxel With Pegfilgrastim and Darbepoetin Alfa Support for the Treatment of Women With Breast Cancer","official_title":"An Open Label Phase 2 Study of Doxorubicin and Cyclophosphamide Followed by Paclitaxel Delivered Every 14 Days With Pegfilgrastim and Darbepoetin Alfa Support for the Adjuvant Treatment of Women With Breast Cancer","primary_completion_date":"2007-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-12-31","last_update":"2010-02-26","description":"This is a study of dose dense doxorubicin/cyclophosphamide (AC) followed by paclitaxel (Taxol; T) with pegfilgrastim (Neulasta) and darbepoetin alfa support in the adjuvant breast cancer setting.","other_id":"20040137","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Breast cancer diagnosis node-positive or high risk node negative\r\n\r\n          -  Estrogen receptor (ER) negative or ER positive (stage IIA, IIB or IIIA) disease.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Metastatic breast cancer\r\n\r\n          -  Clinically significant cardiac disease\r\n      ","sponsor":"Amgen","sponsor_type":"Industry","conditions":"Breast Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Neulasta","description":"6mg Neulasta to be given approximately 24 hours afer each cycle of chemotherapy"},{"intervention_type":"Drug","name":"Drug: Aranesp","description":"If Hb drops below 110, 300mcg Aranesp will be administered."}],"outcomes":[{"outcome_type":"primary","measure":"The proportion of subjects experiencing any delay in any cycle of chemotherapy over the course of the study","time_frame":"3 months"},{"outcome_type":"secondary","measure":"Febrile neutropenic events and adverse event profile will be assessed","time_frame":"4 months"},{"outcome_type":"secondary","measure":"To assess chemotherapy and subject dose delays and reductions which are specific and/or non specific to haematological toxicities","time_frame":"3 months"},{"outcome_type":"secondary","measure":"Frequency of red blood cell (RBC) transfusions","time_frame":"3 months"}]}
{"nct_id":"NCT00337493","start_date":"2005-12-31","phase":"Phase 4","enrollment":155,"brief_title":"Pharmacogenetic Study of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients.","official_title":"A Study to Investigate the Impact of Pharmacogenetics on CellCept Use, in Patients Participating in a Study in Renal Transplantation","primary_completion_date":"2008-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-01-31","last_update":"2012-09-17","description":"This study will determine which, if any, allelic variants of mycophenolic acid (MPA) metabolizing enzymes, drug transporters and drug targets are associated with the observed variation in pharmacokinetic and pharmacodynamic outcomes observed with CellCept usage. Patients participating in study ML17225 will be eligible for this pharmacogenetic investigation, and will have one additional blood sample taken during the study. The anticipated time on study treatment in study ML17225 is 1-2 years, and the target sample size is 500+ individuals.","other_id":"ML19199","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":13,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  patients participating in study ML17225.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  N/A.\r\n      ","sponsor":"Hoffmann-La Roche","sponsor_type":"Industry","conditions":"Kidney Transplantation","interventions":[{"intervention_type":"Drug","name":"Drug: mycophenolate mofetil [CellCept]","description":"Concentration-controlled"},{"intervention_type":"Drug","name":"Drug: mycophenolate mofetil [CellCept]","description":"1g po bid"},{"intervention_type":"Drug","name":"Drug: Cyclosporine or tacrolimus","description":"Reduced"},{"intervention_type":"Drug","name":"Drug: Cyclosporine or tacrolimus","description":"Standard, as prescribed"}],"outcomes":[{"outcome_type":"secondary","measure":"Viral kinetics","time_frame":"Throughout study"},{"outcome_type":"primary","measure":"Correlation of allelic variants of MPA metabolizing genes, membrane transporter genes and target genes with AUC, transplant rejection, GER and drug side effects.","time_frame":"Throughout study"}]}
{"nct_id":"NCT00263523","start_date":"2005-12-05","phase":"Phase 1","enrollment":15,"brief_title":"PET Imaging of Brain 5-HT(1A) Receptors Using [(11)C](-)-RWAY","official_title":"PET Imaging of Brain 5-HT1A Receptors Using [11C](-)-RWAY","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-08-15","last_update":"2017-07-02","description":"This study will use positron emission tomography (PET) and magnetic resonance imaging (MRI) to measure a serotonin receptor subtype in the brain called 5-HT(1A). This receptor is a target for drug therapy to treat anxiety and depression. The study will see if a newly developed radioligand (radioactive substance used in PET scanning to study the receptor systems of the brain) called [(11)C](-)-RWAY is more effective than other radioligands currently used in brain receptor research. Healthy subjects 18-40 years of age may be eligible for this study. Candidates are screened with a physical examination, electrocardiogram, and blood and urine tests. Participants undergo PET and MRI scanning as follows: PET scan PET uses small amounts of a radioactive chemical called a tracer (in this case, [(11)C](-)-RWAY) that \"labels\" active areas of the brain. For the procedure, the subject lies on the scanner bed. A special mask is fitted to the subject's head and attached to the bed to help keep the head still during the scan so the images will be clear. A brief scan is done just before the tracer is injected to provide measures of the brain that will help in the precise calculation of information from subsequent scans. Then, the tracer is injected through a catheter (plastic tube) placed in the arm and pictures are taken for about 2 hours, while the subject lies still on the scanner bed. Subjects return to the clinic for blood and urine tests 24 hours after the scan. MRI The MRI scan is done within 1 year of the PET scan. MRI uses a magnetic field and radio waves to produce images of body tissues and organs-in this case, the brain. The subject lies on a table that is moved into the scanner (a tube-like device), wearing earplugs to muffle the noise of the machine during the scanning process. The space in the scanner is confining and may cause some people to be somewhat anxious. An intercom system allows the subject to speak with the staff member performing the study at all times during the procedure, and the procedure can be stopped at any time.","other_id":"060042","primary_purpose":"Treatment","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        -  INCLUSION CRITERIA:\r\n\r\n        All subjects must be healthy and aged 18-65 years.\r\n\r\n        EXCLUSION CRITERIA:\r\n\r\n        Current psychiatric illness, substance abuse or severe systemic disease based on history\r\n        and physical exam.\r\n\r\n        Any existing physical exam and ECG within one year will be reviewed and if none already\r\n        exists in the chart, these will be obtained and reviewed.\r\n\r\n        Laboratory tests with clinically significant abnormalities.\r\n\r\n        Prior participation in other research protocols or clinical care in the last year such that\r\n        radiation exposure would exceed the annual limits.\r\n\r\n        Pregnancy and breast feeding.\r\n\r\n        Claustrophobia.\r\n\r\n        Presence of ferromagnetic metal in the body or heart pacemaker.\r\n\r\n        Positive HIV test.\r\n\r\n        A history of brain disease.\r\n      ","sponsor":"National Institute of Mental Health (NIMH)","sponsor_type":"NIH","conditions":"Healthy Volunteers","interventions":[{"intervention_type":"Drug","name":"Drug: [11C] (-)-RWAY"}],"outcomes":{}}
{"nct_id":"NCT00420264","start_date":"2005-11-30","phase":"N/A","enrollment":21,"brief_title":"ThermaChoice III Under Local Sedation in the Office Setting","official_title":"Feasibility of Using Gynecare Thermachoice III in the Office Setting Without Conscious Sedation","primary_completion_date":"2008-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-05-31","last_update":"2013-08-14","description":"Investigational study to determine if an endometrial ablation for heavy uterine bleeding, can be tolerated in the office setting without the use of intravenous medication.","other_id":"ThermaChoice III","allocation":"N/A","intervention_model":"Single Group Assignment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":30,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Heavy uterine bleeding\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Uterine or cervical cancer\r\n\r\n          -  Unable to tolerate office hysteroscopy\r\n\r\n          -  Uterine fibroid tumors that distort endometrial cavity\r\n\r\n          -  Uterine cavity greater than 12 cm\r\n\r\n          -  Patients with hyperplasia or premalignant changes of the endometrium\r\n\r\n          -  Active genital or urinary tract infections\r\n\r\n          -  Intrauterine device\r\n\r\n          -  Pregnant or want to become pregnant\r\n      ","sponsor":"Female Pelvic Medicine & Urogynecology Institute of Michigan","sponsor_type":"Other","conditions":"Heavy Uterine Bleeding","interventions":[{"intervention_type":"Device","name":"Device: Uterine Ablation","description":"Uterine Ablation in the office setting to see if the procedure is tolerated w/o sedation"}],"outcomes":[{"outcome_type":"primary","measure":"Tolerability of Uterine Ablation in the office setting","time_frame":"30 days"}]}
{"nct_id":"NCT00322556","start_date":"2005-11-30","phase":"Phase 3","enrollment":55,"brief_title":"Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)","official_title":"A Multicenter Extension Study on the Safety and Efficacy of IgPro10 in Patients With Primary Immunodeficiency (PID)","primary_completion_date":"2008-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-04-30","last_update":"2012-10-26","description":"The objectives of this trial are the assessment of safety and efficacy of IgPro10 in patients with PID, and the assessment of tolerability of high infusion rates. To demonstrate safety, the number of infusions temporally associated with AEs, the rate, severity and relationship of all AEs and the vital sign changes during each infusion will be evaluated.","other_id":"ZLB05_006CR","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":4,"maximum_age":71,"population":"","criteria":"\n        Key Inclusion Criteria:\r\n\r\n        Patients with CVID (Common Variable Immunodeficiency) or XLA (X-linked agammaglobulinemia)\r\n        who:\r\n\r\n        Participated in the Phase III clinical study with intravenous IgPro10 (study number\r\n        ZLB03_002CR) at 3- or 4- weekly intervals for 12 months (referred to as 'old' subjects)\r\n\r\n        OR\r\n\r\n        Were  6 years of age, were on other stable intravenous immunoglobulin therapy (200-800 mg\r\n        IgG per kg body weight) at 3- or 4-week intervals for at least 6 months, AND were\r\n        interested in participating in the Phase III clinical study with subcutaneous IgPro20\r\n        (study number ZLB04_009CR) (referred to as 'new' subjects)\r\n\r\n        Written informed consent\r\n\r\n        Key Exclusion Criteria:\r\n\r\n        Diagnosis of epilepsia\r\n\r\n        Insulin dependent diabetes\r\n\r\n        Administration of steroids (daily  0.15 mg prednisone equivalent/kg/day) or other\r\n        immunosuppressive drugs\r\n\r\n        History of cardiac insufficiency (NYHA III/IV), cardiomyopathy, congestive heart failure,\r\n        severe hypertension\r\n      ","sponsor":"CSL Behring","sponsor_type":"Industry","conditions":"Agammaglobulinemia|IgG Deficiency|Common Variable Immunodeficiency","interventions":[{"intervention_type":"Drug","name":"Drug: Immunoglobulins Intravenous (Human)","description":"Liquid formulation; treatment schedule every 3 or 4 weeks using an individualized regimen with a dose of 0.2 - 0.8 g IgG per kg bw"}],"outcomes":[{"outcome_type":"secondary","measure":"Number of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Illness.","time_frame":"For the duration of the study, up to approximately 29 months."},{"outcome_type":"secondary","measure":"Number of Days of Hospitalization.","time_frame":"For the duration of the study, up to approximately 29 months"},{"outcome_type":"primary","measure":"The Proportion of Infusions With One or More Temporally-associated Adverse Events (AEs).","time_frame":"During each infusion, and within 48 or 72 hours after the end of each infusion.","description":"AEs were considered temporally-associated AEs if they occurred during the infusion or in the period from the start of the infusion until either 48 or 72 hours after the end of the infusion."},{"outcome_type":"primary","measure":"Influence of Infusion Rate on Temporally-Associated AEs","time_frame":"Within 72 hours after each infusion","description":"The total and most frequent (1% or more) number of infusions for which subjects experienced temporally-associated AEs occurring within 72 hours of infusion, by infusion rate (≤ 4 mg/kg/min, ≤ 8 mg/kg/min, and > 8 and ≤ 12 mg/kg/min).\r\nAEs were considered to be temporally-associated AEs if they occurred in the period from the start of the infusion until 72 hours after the end of the infusion."},{"outcome_type":"primary","measure":"Rate of AEs by Severity and Relationship","time_frame":"For the duration of the study, up to approximately 29 months","description":"The AE rate was the number of AEs over the number of infusions administered.\r\nMild AEs: Did not interfere with daily activities; Moderate AEs: Interfered with routine daily activities; Severe AEs: Impossible to perform routine daily activities.\r\nAt least possibly related AEs included possibly related AEs, probably related AEs, and related AEs."},{"outcome_type":"primary","measure":"Number of Subjects With Clinically Significant Changes in Vital Signs.","time_frame":"Before, during, and after each infusion.","description":"Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature."},{"outcome_type":"secondary","measure":"Annualized Rate of Acute Serious Bacterial Infections.","time_frame":"For the duration of the study, up to approximately 29 months","description":"The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.\r\nAcute serious bacterial infections included pneumonia, bacteremia / septicemia, osteomyelitis / septic arthritis, bacterial meningitis, and visceral abscess."},{"outcome_type":"secondary","measure":"Annualized Rate of Any Infection.","time_frame":"For the duration of the study, up to approximately 29 months.","description":"The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.\r\nInfections were classified as all AEs with the system organ class \"infections and infestations\" and AEs with the preferred term \"conjunctivitis\"."},{"outcome_type":"secondary","measure":"Trough Levels of Total Immunoglobulin (IgG) Serum Concentrations.","time_frame":"Prior to each infusion; every 3 or 4 weeks depending upon the dosing schedule.","description":"Mean IgG trough concentration. For this analysis, each subject's values were first aggregated to their median and the median values were then analyzed."}]}
{"nct_id":"NCT02587663","start_date":"2005-11-20","phase":"N/A","enrollment":300,"brief_title":"Extent of Breast Cancer and the Role of Pre-Operative Sonography and MRI","official_title":"Sonography Compared With MRI in Pre-Operative Evaluation of Patients With Breast Cancer to Determine Extent of Breast Disease","primary_completion_date":"2011-11-20","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-11-20","last_update":"2019-05-16","description":"This clinical trial studies mammography and targeted ultrasound with or without whole-breast ultrasound or contrast-enhanced magnetic resonance imaging (MRI) in finding out the extent of disease before surgery in patients with newly diagnosed breast cancer. New diagnostic imaging procedures, such as whole-breast ultrasound or contrast-enhanced MRI, may help find out how far breast cancer has spread. It is not yet known whether mammography and targeted ultrasound are more effective with or without whole-breast ultrasound or contrast-enhanced MRI in finding out how far breast cancer has spread.","other_id":"1B-05-5","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Competent to provide informed consent\r\n\r\n          -  Pathologically proven invasive breast cancer or ductal carcinoma in situ (DCIS)\r\n             originally identified clinically or mammographically and diagnosed by percutaneous\r\n             core biopsy\r\n\r\n          -  Eligible for breast conserving surgery followed by radiation therapy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Women with surgical excisional biopsy that diagnosed the breast cancer\r\n\r\n          -  Women with clinical or mammographic findings where breast conserving surgery is not an\r\n             option\r\n\r\n          -  Women that clinically or mammographically have breast cancers that are fixed to skin\r\n\r\n          -  Women receiving neoadjuvant chemotherapy prior to surgery\r\n\r\n          -  Women having contraindications to contrast-enhanced (CE)-MRI examination (e.g.,\r\n             claustrophobia and allergy to gadolinium)\r\n      ","sponsor":"University of Southern California","sponsor_type":"Other","conditions":"Ductal Breast Carcinoma In Situ|Stage IA Breast Cancer|Stage IB Breast Cancer|Stage II Breast Cancer","interventions":[{"intervention_type":"Procedure","name":"Procedure: Contrast-enhanced Magnetic Resonance Imaging","description":"Undergo bilateral breast contrast enhanced MRI"},{"intervention_type":"Procedure","name":"Procedure: Mammography","description":"Undergo bilateral mammography"},{"intervention_type":"Procedure","name":"Procedure: Therapeutic Conventional Surgery","description":"Undergo breast conserving surgery"},{"intervention_type":"Procedure","name":"Procedure: Ultrasonography","description":"Undergo bilateral whole-breast ultrasound"},{"intervention_type":"Procedure","name":"Procedure: Ultrasonography","description":"Undergo targeted breast ultrasound"},{"intervention_type":"Other","name":"Other: Gadolinium","description":"Contrast agent used in MRI"}],"outcomes":[{"outcome_type":"primary","measure":"Difference between the longest diameter of the index lesion as determined by imaging versus as determined by the pathologist","time_frame":"Up to 4 weeks","description":"Every attempt will be made to identify a transformation for the difference in the lengths of the largest diameters. If none are found, then the data will be summarized with histograms, medians, quartiles, and ranges. If a transformation is found, means, standard deviations, and 95% confidence intervals will be reported instead of the median and quartiles. Differences between three imaging methods will be compared using a paired t-test (or paired rank sum test)."},{"outcome_type":"secondary","measure":"Number of patients identified with invasive breast cancer in women who have dense or no dense breasts as determined by the 3 imaging arms","time_frame":"Up to 4 weeks","description":"The analyses above will be rerun, stratifying by breast density: the differences in the modalities will be estimated for women with dense breasts and without, and the differences between the two groups of women will also be estimated. Dense will be defined as dense parenchyma involving more than 50% of breast volume."}]}
{"nct_id":"NCT00134030","start_date":"2005-11-14","phase":"Phase 3","enrollment":1164,"brief_title":"Combination Chemotherapy, PEG-Interferon Alfa-2b, and Surgery in Treating Patients With Osteosarcoma","official_title":"A Randomized Trial of the European and American Osteosarcoma Study Group to Optimize Treatment Strategies for Resectable Osteosarcoma Based on Histological Response to Pre-operative Chemotherapy","primary_completion_date":"2015-01-31","study_type":"Interventional","rec_status":"Unknown status","last_update":"2018-06-08","description":"This randomized phase III trial is studying combination chemotherapy followed by surgery and two different combination chemotherapy regimens with or without PEG-interferon alfa-2b to compare how well they work in treating patients with osteosarcoma. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Biological therapies, such as PEG-interferon alfa-2b, may interfere with the growth of tumor cells. Giving combination chemotherapy before surgery may shrink the tumor so it can be removed. Giving combination chemotherapy together with PEG-interferon alfa-2b after surgery may kill any remaining tumor cells. It is not yet known whether giving combination therapy together with PEG-interferon alfa-2b is more effective than two different combination chemotherapy regimens alone after surgery in treating osteosarcoma.","other_id":"AOST0331","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":5,"maximum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically confirmed high-grade osteosarcoma, including second malignancies\r\n\r\n               -  Localized or metastatic disease\r\n\r\n               -  The primary tumor must be located in the limbs or axial skeleton, including any\r\n                  of the following sites*:\r\n\r\n                    -  Long bone of upper limb\r\n\r\n                    -  Short bone of upper limb\r\n\r\n                    -  Long bone of lower limb\r\n\r\n                    -  Short bone of lower limb\r\n\r\n                    -  Vertebral column\r\n\r\n                    -  Ribs, sternum, clavicle, or scapula\r\n\r\n                    -  Pelvic bones, sacrum, or coccyx\r\n\r\n          -  Tumor (primary, metastatic, or both) resectable OR is expected to become resectable\r\n             after neoadjuvant induction chemotherapy\r\n\r\n          -  Suitable for neoadjuvant chemotherapy\r\n\r\n          -  Performance status - Lansky 50-100% (for patients under 16 years of age)\r\n\r\n          -  Performance status - Karnofsky 50-100%*\r\n\r\n          -  Performance status - WHO or ECOG 0-2*\r\n\r\n          -  Platelet count ? 100,000/mm?\r\n\r\n          -  Neutrophil count ? 1,500/mm?\r\n\r\n          -  WBC ? 3,000/mm?\r\n\r\n          -  Bilirubin ? 1.5 times upper limit of normal\r\n\r\n          -  Creatinine clearance ? 70 mL/min\r\n\r\n          -  Creatinine based on age as follows:\r\n\r\n               -  No greater than 1.0 mg/dL (for patients 5 to 10 years of age)\r\n\r\n               -  No greater than 1.2 mg/dL (for patients 11 to 15 years of age)\r\n\r\n               -  No greater than 1.5 mg/dL (for patients over 15 years of age)\r\n\r\n          -  Ejection fraction ? 50% by radionuclide angiogram\r\n\r\n          -  Shortening fraction ? 28% by echocardiogram\r\n\r\n          -  Not pregnant or nursing\r\n\r\n          -  Negative pregnancy test\r\n\r\n          -  Fertile patients must use effective contraception\r\n\r\n          -  No known HIV positivity\r\n\r\n          -  No prior chemotherapy for any disease\r\n\r\n          -  Prior radiotherapy for another malignancy allowed\r\n\r\n          -  No prior treatment for osteosarcoma\r\n      ","sponsor":"Children's Oncology Group","sponsor_type":"Other","conditions":"Localized Osteosarcoma|Metastatic Osteosarcoma","interventions":[{"intervention_type":"Drug","name":"Drug: Cisplatin","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: Doxorubicin Hydrochloride","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: Etoposide","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: Ifosfamide","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: Methotrexate","description":"Given IV"},{"intervention_type":"Biological","name":"Biological: Peginterferon Alfa-2b","description":"Given subcutaneously"},{"intervention_type":"Other","name":"Other: Quality-of-Life Assessment","description":"Ancillary studies"},{"intervention_type":"Other","name":"Other: Questionnaire Administration","description":"Ancillary studies"},{"intervention_type":"Procedure","name":"Procedure: Therapeutic Conventional Surgery","description":"Undergo amputation or limb salvage surgery"}],"outcomes":[{"outcome_type":"primary","measure":"Event-free survival","time_frame":"From date of randomization to date of the event, assessed up to 10 years","description":"Will be assessed using the logrank test and expressed using hazard ratios with appropriate confidence intervals."},{"outcome_type":"secondary","measure":"Overall survival","time_frame":"From date of randomization to date of death, assessed up to 10 years","description":"Will be assessed using the logrank test and expressed using hazard ratios with appropriate confidence intervals."},{"outcome_type":"secondary","measure":"Toxicity as measured by CTCAE v3.0","time_frame":"Up to 10 years","description":"Proportions of patients experiencing grade 3 and 4 toxicities will be compared using chi-square tests or Fisher's exact tests where appropriate."},{"outcome_type":"secondary","measure":"Quality of life","time_frame":"Up to 3 years"}]}
{"nct_id":"NCT00287404","start_date":"2005-10-31","enrollment":30,"brief_title":"Measuring Cholesterol in the Fasting and Postmeal State in Patients With Type 2 Diabetes","official_title":"A Comparison of NMR and Chemical Lipid Analysis in the Fasting and Postprandial State in Patients With Type 2 Diabetes","study_type":"Observational","rec_status":"Completed","completion_date":"2006-09-30","last_update":"2007-12-28","description":"Many patients with type 2 diabetes have difficulty attaining cholesterol goals, partly due to the recommendations for fasting measurements that may not be practical in the typical clinical setting. Focus toward therapy is shifting toward non-fasting assessments but little is known about the usefulness of this approach in diabetes, where postmeal cholesterol levels are more abnormal. This is an observational study examining fasting and postmeal lipids (cholesterol) in patients with type 2 diabetes using standard means and NMR.","other_id":"GCRC-2395","time_perspective":"Prospective","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age 20-75\r\n\r\n          -  male or female\r\n\r\n          -  Type 2 diabetes\r\n\r\n          -  Hemoglobin A1C less than 9 at last measurement (within 3 months)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnancy\r\n\r\n          -  Non-English speaking.\r\n\r\n          -  Inability to fast for 12 hours\r\n\r\n          -  Hypoglycemia requiring assistance in the previous 6 months\r\n\r\n          -  Unwilling to consume the standardized meal\r\n      ","sponsor":"University of North Carolina","sponsor_type":"Other","conditions":"Type 2 Diabetes","interventions":{},"outcomes":{}}
{"nct_id":"NCT00238108","start_date":"2005-10-31","phase":"Phase 2","enrollment":16,"brief_title":"Melatonin Supplements for Improving Sleep in Individuals With Hypertension","official_title":"Melatonin Supplementation in Hypertensive Patients","primary_completion_date":"2010-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-08-31","last_update":"2017-11-14","description":"This study will evaluate the effectiveness of treatment with melatonin supplements in improving sleep in individuals with high blood pressure who are taking beta-blockers.","other_id":"R21AT002713","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":35,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosed with uncomplicated hypertension\r\n\r\n          -  Currently being treated with Atenolol (a beta-blocker)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of medical illness other than essential hypertension\r\n\r\n          -  Personal or family history of psychiatric illness\r\n\r\n          -  Current use of any medication other than anti-hypertensive drugs\r\n\r\n          -  Any recent travel across time zones\r\n\r\n          -  History of working various shifts on an irregular basis\r\n      ","sponsor":"Brigham and Women's Hospital","sponsor_type":"Other","conditions":"Sleep Disorders|Hypertension","interventions":[{"intervention_type":"Drug","name":"Drug: Melatonin","description":"2,5 mg melatonin, by mouth, 1 per day, for 3-4 weeks"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"Sleep Quality","time_frame":"Measurement after 3 weeks of supplementation","description":"Sleep efficiency as measured by polysomnography (total time asleep as a percentage of the 8-hour sleep opportunity)"},{"outcome_type":"secondary","measure":"Change in Systolic Blood Pressure","time_frame":"Measurement after 3 weeks of supplementation compared to baseline","description":"Systolic blood pressure as measured by 24-h ambulatory blood pressure monitoring"}]}
{"nct_id":"NCT02239146","start_date":"2005-10-31","phase":"Phase 1","enrollment":43,"brief_title":"Safety of rFXIII in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary Bypass","official_title":"A Multi-Centre, Randomised, Double-Blind, Placebo Controlled, Dose Escalation Trial on Safety and Pharmacokinetics of Recombinant Factor XIII (rFXIII) in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary Bypass","primary_completion_date":"2008-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-01-31","last_update":"2017-01-11","description":"This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate the safety of escalating single doses of rFXIII (recombinant factor XIII, catridecacog) administered following first time myocardial revascularization requiring cardiopulmonary bypass (CPB).","other_id":"F13CARD-1660","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":35,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subject is undergoing his/her first myocardial revascularization\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Previous participation (randomisation and dosing) in this trial\r\n\r\n          -  Subject has a history of cerebrovascular event (including thrombotic or haemorrhagic\r\n             stroke or transient ischaemic attack (TIA)) and/or extra-myocardial thromboembolic\r\n             events, e.g., deep vein thrombosis (DVT) or pulmonary embolus (PE)\r\n\r\n          -  Subject required a pre-operative (within 30 days) transfusion of any blood and/or\r\n             blood product\r\n\r\n          -  Subject has a current atrial fibrillation or history of atrial fibrillation\r\n      ","sponsor":"Novo Nordisk A/S","sponsor_type":"Industry","conditions":"Acquired Bleeding Disorder|Cardiac Surgery Requiring Cardiopulmonary Bypass","interventions":[{"intervention_type":"Drug","name":"Drug: catridecacog","description":"Single doses of rFXIII administered intravenously (i.v.) to eight subjects in each of the four dose groups (11.9, 25, 35 and 50 IU/kg)."},{"intervention_type":"Drug","name":"Drug: placebo","description":"Single doses of placebo administered intravenously (i.v.) to two subjects in each of the four dose groups (11.9, 25, 35 and 50 IU/kg)."}],"outcomes":[{"outcome_type":"primary","measure":"Incidence and severity of adverse events","time_frame":"From dosing up to 5-7 weeks ± 3 days after trial product administration"},{"outcome_type":"secondary","measure":"Incidence and magnitude of laboratory abnormalities following administration of rFXIII","time_frame":"From dosing up to 5-7 weeks ± 3 days after trial product administration"},{"outcome_type":"secondary","measure":"Incidence of antibodies to FXIII-A subunit","time_frame":"From dosing up to 5-7 weeks ± 3 days after trial product administration"},{"outcome_type":"secondary","measure":"Incidence of anti-yeast antibodies","time_frame":"From dosing up to 5-7 weeks ± 3 days after trial product administration"}]}
{"nct_id":"NCT00598624","start_date":"2005-09-30","phase":"Phase 2","enrollment":175,"brief_title":"Clinical Trial to Evaluate the Safety and Efficacy of Treosulfan Based Conditioning Prior to Allogeneic Haematopoietic Stem Cell Transplantation (HSCT)","official_title":"Clinical Phase II Trial to Evaluate the Safety and Efficacy of Treosulfan Based Conditioning Prior to Allogeneic Haematopoietic Stem Cell Transplantation in Patients With Haematological Malignancies","primary_completion_date":"2009-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2010-12-31","last_update":"2009-08-11","description":"This is a multicentric, non-randomized, non-controlled open-label phase II trial to evaluate the safety and efficacy of treosulfan in a combination regimen with fludarabine as conditioning therapy prior to allogeneic stem cell transplantation (SCT) in patients with haematological malignancies. The aim is to demonstrate a clinical benefit compared with historical data on intravenous busulfan (BusulfexTM, BusilvexTM), the only drug so far registered in the indication conditioning before allogeneic stem cell transplantation.","other_id":"2005-005182-11","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":69,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patients with haematological malignancies, according to WHO classification, such as:\r\n\r\n               -  acute myeloid leukaemia -AML- in CR1 except \"low-risk cases\" defined by t(15;17),\r\n                  t(8;21), inv 16 or normal cytogenetics at diagnosis with FLT3-ITD negative and\r\n                  NPM-1 positive, with no high risk clinical criteria\r\n\r\n               -  any AML beyond CR1\r\n\r\n               -  acute lymphoblast leukaemia -ALL- in CR1 only if at \"high risk\" defined by\r\n                  cytogenetics as t(9;22), t(4;11) or for persistence of minimal residual disease\r\n                  (MRD)\r\n\r\n               -  any ALL beyond CR1\r\n\r\n               -  chronic myeloid leukaemia -CML- in chronic phase (CP) or accelerated phase (AP)\r\n                  intolerant/not responsive to TK-inhibitors\r\n\r\n               -  myeloproliferative disorders -MPD-\r\n\r\n               -  myelodysplastic syndrome -MDS- with intermediate or high risk International\r\n                  Prognostic Scoring System (IPSS)\r\n\r\n               -  diffuse large cell lymphoma -DLCL- with a chemosensitive relapse or beyond CR1\r\n\r\n               -  lymphoblastic and Burkitt lymphoma with a chemosensitive relapse or beyond CR1\r\n\r\n               -  mantle cell lymphoma -MCL- with a chemosensitive relapse or beyond CR1\r\n\r\n               -  follicular lymphoma -FCL- with a chemosensitive relapse or beyond CR2\r\n\r\n               -  Hodgkin lymphoma -HD- with a chemosensitive relapse or beyond CR1\r\n\r\n               -  chronic lymphocytic leukaemia -CLL- at \"poor risk\" in CR1 or with a\r\n                  chemosensitive relapse\r\n\r\n               -  CLL relapsing after high dose chemotherapy\r\n\r\n               -  T-cell non Hodgkin lymphoma -T-NHL- in CR1 or beyond\r\n\r\n               -  multiple myeloma -MM- at high risk for cytogenetics or ISS stage 3 in CR1\r\n                  following high dose chemotherapy\r\n\r\n               -  MM at any relapse/progression except refractory disease\r\n\r\n          2. Availability of an HLA-identical sibling donor (MRD) or HLA-identical unrelated donor\r\n             (MUD)\r\n\r\n               -  HLA-identity defined by the following markers: A, B, DRB1, DQB1 or a single or\r\n                  double Cord Blood unit (CB) with at least a 4 out of 6 HLA-matching by the\r\n                  following markers: A, B and DRB.\r\n\r\n             A) identity between the 2 CB units and the recipient;\r\n\r\n             B) Two identical CB units with one or two mismatches with the recipient;\r\n\r\n             C) Two CB units with one mismatch between them and two mismatches with the recipient.\r\n             We will prefer mismatches either for class I or for class II antigens; we will avoid\r\n             mismatches concerning both classes I and II together.\r\n\r\n          3. Target graft size (unmanipulated, preferably not cryopreserved)\r\n\r\n               -  bone marrow: 2 to 10 x 106 CD34+ cells/kg BW recipient or > 2 x 108 nucleated\r\n                  cells/kg BW recipient or\r\n\r\n               -  peripheral blood: 4 to 10 x 106 CD34+ cells/kg BW recipient\r\n\r\n          4. Age > 18 and < 70 years\r\n\r\n          5. Karnofsky Index > 80 %\r\n\r\n          6. Adequate contraception in female patients of child-bearing potential\r\n\r\n          7. Written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Secondary malignancies\r\n\r\n          2. Previous allogeneic transplantation\r\n\r\n          3. Hematopoietic cell transplantation-specific comorbidity index > 4 (HCT-CI Sorror et\r\n             al, Appendix M)\r\n\r\n          4. Known and manifested malignant involvement of the CNS\r\n\r\n          5. Active infectious disease\r\n\r\n          6. HIV- positivity or active hepatitis infection\r\n\r\n          7. Impaired liver function (Bilirubin > upper normal limit; Transaminases > 3.0 x upper\r\n             normal limit)\r\n\r\n          8. Impaired renal function (Creatinine-clearance < 60 ml/min; Serum Creatinine > 1.5 x\r\n             upper normal limit).\r\n\r\n          9. Pleural effusion or ascites > 1.0 L\r\n\r\n         10. Pregnancy or lactation\r\n\r\n         11. Known hypersensitivity to treosulfan and/or fludarabine\r\n\r\n         12. Participation in another experimental drug trial within 4 weeks before day -6\r\n\r\n         13. Non-co-operative behaviour or non-compliance\r\n\r\n         14. Psychiatric diseases or conditions that might impair the ability to give informed\r\n             consent\r\n      ","sponsor":"IRCCS San Raffaele","sponsor_type":"Other","conditions":"Leukemia|Chronic Myeloid Leukemia|Myelodysplastic Syndrome|Diffuse Large Cell Lymphoma|Hodgkin Lymphoma|Chronic Lymphocytic Leukemia|Multiple Myeloma","interventions":[{"intervention_type":"Drug","name":"Drug: Treosulfan IV","description":"Treosulfan i.v.: 14 g/m/d from day -6 to day -4"}],"outcomes":[{"outcome_type":"primary","measure":"Efficacy: Evaluation of engraftment","time_frame":"28 days"},{"outcome_type":"primary","measure":"Safety: Evaluation of the incidence of CTC grade 3 and 4 adverse events","time_frame":"between day -6 and day +28"},{"outcome_type":"secondary","measure":"Efficacy: Evaluation of disease free survival (DFS)","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Efficacy: Evaluation of overall survival (OS)","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Efficacy: Evaluation of relapse incidence (RI)","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Efficacy: Documentation of donor chimerism","time_frame":"on day +28, +56 and +100"},{"outcome_type":"secondary","measure":"Safety: Evaluation of incidence of non-relapse mortality (NRM)","time_frame":"on day +28 and day +100"},{"outcome_type":"secondary","measure":"Safety: cumulative incidence of NRM","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Safety: Evaluation of cumulative incidence and severity of acute and chronic graft vs. host disease (GvHD)","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Safety: EBV reactivation","time_frame":"1 year"}]}
{"nct_id":"NCT00433719","start_date":"2005-09-30","phase":"N/A","enrollment":253,"brief_title":"Immediate Versus Deferred Antiretroviral Therapy for HIV-Associated Tuberculous Meningitis","official_title":"Randomised Controlled Trial of Immediate Versus Deferred Antiretroviral Therapy for HIV-Associated Tuberculous Meningitis","primary_completion_date":"2008-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2008-12-31","last_update":"2008-08-07","description":"The optimal time to initiate antiretroviral therapy (ART) in HIV-associated tuberculous meningitis (TBM) unknown. There are concerns that immediate ART may worsen rather than improve outcome, because drug interactiond and toxicities or development of an intracerebral immune reconstitution inflammatory syndrome (IRIS). Conversely, delaying ART may result in increased HIV-related deaths. To answer this question, we are conducting a randomised, double-blind placebo-controlled trial comparing immediate and deferred ART in HIV-infected patients presenting with TBM, to assess effect on survival.","other_id":"OXTREC 023-04","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":15,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  age 15 years or older\r\n\r\n          -  HIV antibody positive\r\n\r\n          -  clinical diagnosis of TB meningitis\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  positive CSF Gram or India ink stain\r\n\r\n          -  known or suspected pregnancy\r\n\r\n          -  antituberculous treatment 8 - 30 days immediately prior to recruitment\r\n\r\n          -  previous antiretroviral therapy\r\n\r\n          -  laboratory contraindications to antiretroviral or antituberculous therapy\r\n\r\n          -  lack of consent.\r\n      ","sponsor":"University of Oxford","sponsor_type":"Other","conditions":"HIV Infections|Tuberculous Meningitis","interventions":[{"intervention_type":"Drug","name":"Drug: Combivir and efavirenz","description":"Arm 1: Combivir and efavirenz for 12 months Arm 2: Placebo for 2 months then Combivir and efavirenz for 10 months"}],"outcomes":[{"outcome_type":"primary","measure":"Mortality","time_frame":"9 months"},{"outcome_type":"secondary","measure":"Mortality","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Fever clearance time"},{"outcome_type":"secondary","measure":"Coma clearance time"},{"outcome_type":"secondary","measure":"CD4 count","time_frame":"12 months"},{"outcome_type":"secondary","measure":"plasma HIV RNA","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Grade 3 or 4 adverse event","time_frame":"Any"},{"outcome_type":"secondary","measure":"Neurological disability","time_frame":"12 months"}]}
{"nct_id":"NCT00200538","start_date":"2005-09-30","phase":"Phase 2","enrollment":52,"brief_title":"Efficacy and Tolerability of Memantine in Frontotemporal Dementia (FTD) Patients","official_title":"Double-blind, Parallel Group, Placebo-controlled Trial of the Efficacy and Tolerability of Memantine (20 mg) in Frontotemporal Dementia (FTD) Patients","study_type":"Interventional","rec_status":"Completed","last_update":"2013-05-03","description":"The purpose of this trial is to assess the efficacy and tolerability of memantine (anti-excitotoxic, neuroprotective treatment currently used in Alzheimer's disease [AD]) in frontotemporal dementia patients after a one-year treatment.","other_id":"BRD 05/1-E","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":45,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with FTD based on the criteria defined by the Lund and Manchester groups'\r\n             consensus statement (revised in 1998), whose disease has been progressing during the\r\n             last year.\r\n\r\n          -  MMSE score of 19 or higher\r\n\r\n          -  Men and women aged 45 to 75 years\r\n\r\n          -  Without speech, visuospatial, or episodic memory impairments\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Age > 76 years\r\n\r\n          -  Illiterate or misunderstanding patients\r\n\r\n          -  Patients with cancer, heart disease, lung disease, kidney disease (creatinine > 200\r\n             mg/dL), or epilepsy\r\n      ","sponsor":"Nantes University Hospital","sponsor_type":"Other","conditions":"Dementia","interventions":[{"intervention_type":"Drug","name":"Drug: memantine"}],"outcomes":{}}
{"nct_id":"NCT00228631","start_date":"2005-09-30","enrollment":7,"brief_title":"Analysis of T-Cell Immune Reconstitution Following Allogeneic Hematopoietic BMT for Severe SCD","official_title":"Analysis of T-Cell Immune Reconstitution Following Allogeneic Hematopoietic Stem Cell Transplantation for Severe Sickle Cell Disease (ImmuneReconstSCD)","primary_completion_date":"2011-08-31","study_type":"Observational","rec_status":"Completed","completion_date":"2012-07-31","last_update":"2014-05-26","description":"In this study, patient blood samples from NMA transplants will be provided by Pittsburgh, and samples from myeloablative transplants will be provided by Atlanta (comparative controls). Samples would be obtained pre- and post-BMT from the recipient at a total of 7 timepoints, and from the donor at one timepoint.","other_id":"IRB00021821","observational_model":"Cohort","sampling_method":"Probability Sample","gender":"All","minimum_age":0.5,"maximum_age":21,"population":"At in-patient or out-patient transplant clinic (All sickle cell disease bone marrow\r\n        transplant patients will be offered participation)","criteria":"\n        Inclusion Criteria:\r\n\r\n        Undergoing allogeneic bone marrow transplantation for sickle cell disease.\r\n\r\n        Exclusion Criteria:\r\n\r\n        -\r\n      ","sponsor":"Emory University","sponsor_type":"Other","conditions":"Sickle Cell Disease","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"To determine the rate of T cell immune reconstitution in children with sickle cell disease","time_frame":"1 year after accrual closed"}]}
{"nct_id":"NCT00197873","start_date":"2005-09-30","phase":"N/A","enrollment":84,"brief_title":"Lactobacillus Rhamnosus in Prevention of Chemotherapy-related Diarrhoea","official_title":"Randomized, Double Blind, Placebo Controlled, Cross-over Phase II Study on the Effects of Lactobacillus Rhamnosus GG Supplementation in Patients on 1st Line XELOXA Treatment for Metastatic Colorectal Cancer","primary_completion_date":"2018-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2018-12-31","last_update":"2018-02-22","description":"Chemotherapy may cause diarrhoea, which may be associated with treatment delay and infections. The purpose of the study is to investigate whether oral supplementation with lactobacilli will alleviate chemotherapy related diarrhoea. Patients diagnosed with advanced colorectal cancer and who will receive chemotherapy will be randomly assigned to receive either lactobacilli or placebo during chemotherapy. The study is a prospective, multicenter, randomized, double-blind, placebo-controlled study. The primary outcome measure is frequency of moderate/severe diarrhoea. The study will also address safety and tolerability of chemotherapy, response to chemotherapy, and serum growth factor levels.","other_id":"ML18581","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Prevention","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with histologically confirmed diagnosis of CRC, chemotherapy nave for\r\n             metastatic disease (prior adjuvant chemotherapy for CRC allowed), who are scheduled to\r\n             start capecitabine treatment as first line chemotherapy for metastatic disease\r\n\r\n          -  Age 18 or older\r\n\r\n          -  Measurable or non-measurable metastatic disease\r\n\r\n          -  Performance status ECOG performance status 0-2\r\n\r\n          -  Life expectancy greater than 3 months\r\n\r\n          -  Thrombocytes 100,000/L or greater, neutrophils 1.500/l or greater, Aspartate amino\r\n             transferase/Alanine amino transferase <= 2.5 x Upper limit of normal (ULN) (< 5 x ULN\r\n             if liver metastases present), Alkaline phosphatase <=2.5 x ULN (< 5 x ULN if liver\r\n             metastases present), Serum bilirubin <= 1.5 x ULN, Serum Creatinine <= 1.5 x ULN,\r\n             Urine dipstick of proteinuria <2+ (or U-Prot <100mg/dl). Patients discovered to have\r\n             2+ or greater proteinuria on dipstick urinalysis at baseline, must undergo a 24-hour\r\n             urine collection and must have <= 1 g of protein/24 hr\r\n\r\n          -  Women of childbearing potential must have a negative serum pregnancy test done prior\r\n             to the administration of bevacizumab. Patient and their partner should prevent\r\n             pregnancy (oral contraceptives, intrauterine contraceptive device, barrier method of\r\n             contraception in conjunction with spermicidal jelly or surgically sterile) up to at\r\n             least 6 months after last treatment completion or the last drug dose, whatever happens\r\n             first\r\n\r\n          -  Signed written informed consent according to ICH/GCP and the local regulations\r\n             (approved by the Independent Ethics Committee [IEC]) will be obtained prior to any\r\n             study specific screening procedures\r\n\r\n          -  Patient must be able to comply with the protocol\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior treatment with first-line chemotherapy for metastatic CRC\r\n\r\n          -  Adjuvant treatment with bevacizumab within 12 months\r\n\r\n          -  Acute or chronic diarrhea or colostomy\r\n\r\n          -  Major surgical procedure, open biopsy or significant traumatic injury within 28 days\r\n             prior to Day 0 (Patients must have recovered from any major surgery)\r\n\r\n          -  Near future planned radiotherapy for underlying disease (prior completed radiotherapy\r\n             treatment allowed)\r\n\r\n          -  Clinical or radiological evidence of CNS metastases\r\n\r\n          -  Past or current history within the last 5 years of malignancies except for the\r\n             indication under this study and curatively treated Basal and squamous cell carcinoma\r\n             of the skin or In-situ carcinoma of the cervix\r\n\r\n          -  Serious non-healing wound or ulcer\r\n\r\n          -  Evidence of bleeding diathesis or coagulopathy\r\n\r\n          -  Uncontrolled hypertension\r\n\r\n          -  Clinically significant (i.e. active) cardiovascular disease for example\r\n             cerebrovascular accidents ( 6 months), myocardial infarction ( 6 months), unstable\r\n             angina, New York Heart Association (NYHA) grade II or greater congestive heart\r\n             failure, serious cardiac arrhythmia requiring medication\r\n\r\n          -  Treatment with any investigational drug (including IMMP, EGFR inhibitors) or\r\n             participation in another investigational study within 30 days prior to enrolment\r\n\r\n          -  Evidence of other disease, metabolic dysfunction, physical examination finding, or\r\n             clinical laboratory finding giving reasonable suspicion of a disease or condition that\r\n             contraindicates the treatment or patient at high risk from treatment complications\r\n\r\n          -  Ongoing treatment with aspirin (> 325 mg/day), continuous high dose NSAIDS or other\r\n             medications known to predispose to gastrointestinal ulceration\r\n\r\n          -  Pregnancy (positive serum pregnancy test) and lactation\r\n\r\n          -  Any other serious or uncontrolled illness which, in the opinion of the investigator,\r\n             makes it undesirable for the patient to enter the trial\r\n      ","sponsor":"University of Helsinki","sponsor_type":"Other","conditions":"Colorectal Cancer","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Lactobacillus Rhamnosus supplementation","description":"Lactophilus supplementation is administered during chemotherapy."},{"intervention_type":"Other","name":"Other: Placebo administration.","description":"Placebo is administered during chemotherapy."}],"outcomes":[{"outcome_type":"primary","measure":"Effect on the treatment-related grade 2 to 4 diarrhoea","time_frame":"18 weeks","description":"Numbers of bowel movements per day."},{"outcome_type":"secondary","measure":"Effect on treatment related toxicity other than diarrhea","time_frame":"18 weeks","description":"Adverse effects detected in the study groups."},{"outcome_type":"secondary","measure":"Association between supplementation and response","time_frame":"18 weeks","description":"Response rate assessed with imaging."},{"outcome_type":"secondary","measure":"Effect on resectability of liver metastases","time_frame":"1 year","description":"Numbers of liver resections carried out."}]}
{"nct_id":"NCT00418977","start_date":"2005-09-30","phase":"N/A","enrollment":59,"brief_title":"Comparing the Effectiveness of Two Therapies to Treat Signs of Anorexia Nervosa in Adolescents","official_title":"Early Identification and Treatment of Anorexia Nervosa","primary_completion_date":"2011-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-08-31","last_update":"2015-12-23","description":"This study will compare the effectiveness of two therapies to treat early signs of anorexia nervosa in adolescents.","other_id":"GCO 04-0978","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":10,"maximum_age":17,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Living with family or guardian\r\n\r\n          -  Medically stable for outpatient treatment\r\n\r\n          -  Meets two to three criteria for anorexia nervosa\r\n\r\n          -  Receiving a stable dose of psychotropic medication (if applicable)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Meets DSM-IV criteria for anorexia nervosa\r\n\r\n          -  Current psychotic illness, alcohol or drug dependence, or medical or physical\r\n             conditions known to influence eating, weight, or menstrual status\r\n\r\n          -  Previous participation in study treatment\r\n\r\n          -  Unable to withdraw from current psychological treatment\r\n      ","sponsor":"Icahn School of Medicine at Mount Sinai","sponsor_type":"Other","conditions":"Eating Disorders","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Family-Based Therapy (\"Maudsley Method\")","description":"The goal of FBT is to resolve the eating disorder and return the patient to healthy psychosocial and physiological development through active family involvement across three treatment phases. In Phase I, therapy is focused on the disordered eating. The therapist primarily makes careful, persistent requests for united parental action toward re-feeding and/or regulating eating habits and directs the discussion so as to create and reinforce a strong parental alliance around their efforts at feeding their child. In Phase II, the goal is to gradually transfer control over eating back to the participant, with the parents still maintaining general oversight and responsibility for continued progression toward healthy habits. In Phase III, the central goal is establishment of a healthy child or adolescent relationship with the parents where disordered eating is not the basis of interaction."},{"intervention_type":"Behavioral","name":"Behavioral: Individual Supportive Psychotherapy","description":"The goal of ISP is for the patient to understand and address the psychological issues underlying the origin and maintenance of the eating disorder. This work is done directly with the child/adolescent. In this treatment, eating disorders are seen as complicated (e.g., they tend to mask other underlying difficulties). In Phase I, the aims are to establish a sound therapeutic relationship, obtain a comprehensive description of the eating problem and its development, identify underlying problems that might be responsible for the disordered eating, and inform the patient about the dangers of eating disorders. Phase II encourages participants to explore underlying emotional problems, facilitates self-disclosure and expression of feelings, and fosters independence. Phase III focuses on how other underlying issues might affect future adjustment."}],"outcomes":[{"outcome_type":"secondary","measure":"BMI","time_frame":"up to 1 year","description":"body mass index. This variable informs the calculation of the outcome variable of BMI Z-score."},{"outcome_type":"secondary","measure":"BMI Percentile","time_frame":"up to 1 year","description":"Body Mass Index (BMI) percentile. This is not a primary outcome variable."},{"outcome_type":"primary","measure":"Body Mass Index (BMI) Z-score","time_frame":"up to 1 year","description":"Z-score was calculated using the Baylor College of Medicine Children's Nutrition Research Center's online BMI calculator"},{"outcome_type":"secondary","measure":"Height","time_frame":"up to 1 year","description":"This variable informs the calculation of the outcome variable of BMI Z-score."},{"outcome_type":"secondary","measure":"Weight","time_frame":"up to 1 year","description":"This variable informs the calculation of the outcome variable of BMI Z-score."}]}
{"nct_id":"NCT00904969","start_date":"2005-09-30","phase":"N/A","enrollment":55,"brief_title":"A Pre-Market Study of the American Medical Systems (AMS) Transobturator Male Sling System for the Treatment of Male Stress Urinary Incontinence","official_title":"A Pre-Market Study of the AMS Transobturator Male Sling System for the Treatment of Male Stress Urinary Incontinence","primary_completion_date":"2009-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-11-30","last_update":"2018-01-30","description":"The purpose of this study is to obtain surgical technique data for use in physician education and training and to collect early clinical outcomes data for future publication.","other_id":"AMS051","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. The subject has agreed to be implanted with the AMS Male Transobturator Sling System.\r\n\r\n          2. The subject is willing and able to give valid informed consent.\r\n\r\n          3. The subject is > 40 years of age.\r\n\r\n          4. The subject has confirmed stress urinary incontinence for at least 6 months and uses\r\n             no more than 8 pads per day for incontinence management.\r\n\r\n          5. The subject has any of the following: an observable degree of incontinence during\r\n             stress related activities, more than one pad is used in a 24 hour period, has more\r\n             than two episodes of incontinence per day.\r\n\r\n          6. Internal sphincter contractility confirmed by endoscopic view.\r\n\r\n          7. The subject's primary etiology is TUR, TURP, radical prostatectomy, open\r\n             prostatectomy, or suprapubic prostatectomy\r\n\r\n          8. Pre-existing urological conditions, other than incontinence have been treated and are\r\n             under control.\r\n\r\n          9. The subject is willing and able to return for follow-up evaluations and questionnaire\r\n             completion according to the study protocol.\r\n\r\n         10. The subject is a good surgical candidate.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. The subject has a neurogenic bladder condition that is not treatable or controllable\r\n             by pharmacological or alternative methods.\r\n\r\n          2. The subject has an atonic bladder.\r\n\r\n          3. The subject has a post-void residual > 75 cc.\r\n\r\n          4. The subject has detrusor-external sphincter dyssynergia.\r\n\r\n          5. The subject has a urinary tract infection (UTI).\r\n\r\n          6. The subject was treated with pelvic radiation within the last 6 months.\r\n\r\n          7. The subject currently has an inflatable penile prosthesis.\r\n\r\n          8. The subject self-catheterizes.\r\n\r\n          9. The subject has symptomatic or unstable bladder neck stricture disease.\r\n\r\n         10. The subject has a history of urethral strictures that may require repetitive\r\n             instrumentation.\r\n\r\n         11. The subject has previously had a urethral Sling System, an AMS Sphincter 800, or any\r\n             implanted device for the treatment of urinary incontinence (not including bulking\r\n             agents).\r\n\r\n         12. The subject has a history of connective tissue or autoimmune conditions.\r\n\r\n         13. The subject has a compromised immune system.\r\n\r\n         14. The subject has renal insufficiency, and upper and/or lower urinary tract relative\r\n             obstruction.\r\n\r\n         15. The subject's reading level is judged inadequate for reading and understanding the\r\n             quality of life questionnaires and other study materials.\r\n      ","sponsor":"American Medical Systems","sponsor_type":"Industry","conditions":"Urinary Incontinence, Stress","interventions":[{"intervention_type":"Device","name":"Device: The AMS Male Transobturator Sling System","description":"The AMS Male Transobturator Sling System was developed to treat urinary stress incontinence in men resulting from intrinsic sphincter deficiency (ISD) secondary to radical prostatectomy. The Male Transobturator Sling System procedure is minimally invasive and consists of using two single-use needle passers and passing them through two small incisions over the obturator foramen. The needles are pushed in an arc through the tissue and exited at a perineal incision. Once the passers are through the perineal incision, the Sling System mesh arms are attached to the needles which are then pulled back through the needle track to their points of origin over the obturator foramen. The Sling System is subsequently tensioned and all incisions are closed."},{"intervention_type":"Device","name":"Device: AdVance Male Sling","description":"A transobturator sling for the treatment of post-prostatectomy incontinence"}],"outcomes":[{"outcome_type":"secondary","measure":"Procedural and Device Complication Rates","time_frame":"Procedure to 24 Months Post implant","description":"Percentage of participants with serious and non-serious adverse events."},{"outcome_type":"primary","measure":"Procedural Endpoint: Procedure Time From First Incision to Closing.","time_frame":"During Procedure, Approximately 60 Minutes","description":"Characterize procedure time from first incision to closing."},{"outcome_type":"primary","measure":"Procedural Endpoint: Type of Anesthesia Used","time_frame":"During Procedure, Approximately 60 Minutes","description":"Describe the type of anesthesia used."},{"outcome_type":"primary","measure":"Procedural Endpoint: Rate of Foley Catheter Use - Intraoperative","time_frame":"During Procedure, Approximately 60 Minutes","description":"Number of participants requiring the use of a foley catheter intra-operatively."},{"outcome_type":"primary","measure":"Procedural Endpoint: Rate of Foley Catheter Use - Post-operative","time_frame":"post-operative to discharge","description":"Number of participants requiring the use of a foley catheter who were able to void prior to discharge."},{"outcome_type":"primary","measure":"Procedural Endpoint: Rate of Foley Catheter Use - Post-discharge","time_frame":"post discharge","description":"Number of participants requiring the use of a foley catheter post-discharge following Bladder Management instructions."},{"outcome_type":"primary","measure":"Procedural Endpoint: Descriptive Procedural Parameters - Use of Tack Sutures","time_frame":"During Procedure, Approximately 60 Minutes","description":"Characterize procedural parameters including the use of tack sutures."},{"outcome_type":"primary","measure":"Procedural Endpoint: Descriptive Procedural Parameters - Muscle Dissection","time_frame":"During Procedure, Approximately 60 Minutes","description":"Characterize procedural parameters, including muscle dissection across all participants."},{"outcome_type":"primary","measure":"Procedural Endpoint: Descriptive Procedural Parameters - Movement of Urethral Bulb While Tensioning","time_frame":"During Procedure, Approximately 60 Minutes","description":"Characterize procedural parameters, including the movement of urethral bulb while tensioning in all participants."},{"outcome_type":"primary","measure":"Device Success as Defined as Successful Placement of the Device in Desired Position Peri-operatively","time_frame":"During Procedure, Approximately 60 Minutes","description":"Summarize device success as defined as a successful placement of the device in a desired position, peri-operatively, in participants."},{"outcome_type":"secondary","measure":"Subject Satisfaction Endpoint: 1-Hour Pad Weight","time_frame":"Baseline to 24 month","description":"Summarize subject satisfaction of 1-hour pad weight for participants."},{"outcome_type":"secondary","measure":"Subject Satisfaction Endpoint: 24-Hour Pad Weight","time_frame":"Baseline to 24 month","description":"Summarize subject satisfaction with 24-hour pad weight across participants."},{"outcome_type":"secondary","measure":"Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (1 Hour Pad Weight Test)","time_frame":"Baseline to 24 month","description":"Summarize the percent of subjects that have a decrease of pad weight of 25%, 50%, or 75% at follow-up (1-hour pad weight test used)."},{"outcome_type":"secondary","measure":"Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (24 Hour Pad Weight Test)","time_frame":"Baseline to 24 Month","description":"Summarize the percent of subjects that have a decrease of pad weight of 25%, 50%, or 75% at follow-up (24-hour pad weight test used)."},{"outcome_type":"secondary","measure":"Subject Satisfaction Endpoint: Pads Per Day Use","time_frame":"Baseline to 24 Months","description":"Summarize the subject satisfaction using pads per day use collected in follow-up in participants."},{"outcome_type":"secondary","measure":"Subject Satisfaction Endpoint: Quality of Life I-QOL Scores","time_frame":"Baseline to 24 Months","description":"The Incontinence Quality of Life (I-QOL) questionnaire contains 22 items, each with a 5-point Likert-type response scale, evaluating a subject's quality of life with respect to his urinary problems or incontinence. A possible total score can be 0-100, with a higher score meaning less problems."},{"outcome_type":"secondary","measure":"Subject Satisfaction Endpoint: Quality of Life International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF) Scores","time_frame":"Baseline to 24 Months","description":"The ICIQ-SF questionnaire evaluates the impact of urinary incontinence on quality of life through four questions that evaluate the frequency, severity and impact of urinary incontinence. A set of eight self-diagnosis items related to the causes or situations of urinary incontinence experienced by the subject are also assessed. Scores may range from 0 to 21. Improvement in the subject's quality of life from baseline to follow-up is indicated by a decrease in the ICIQ-SF score."},{"outcome_type":"secondary","measure":"Subject Satisfaction Endpoint: Quality of Life UCLA (University of California Los Angeles) / RAND (RAND Corporation) Scores","time_frame":"Baseline to 24 Months","description":"Improvement in the subject's quality of life from baseline to follow-up is indicated by an increase in the UCLA/RAND urinary function score. Scores may range from 0 to 100."},{"outcome_type":"secondary","measure":"Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status","time_frame":"6 Weeks post implant to 24 Months","description":"Physician evaluation of subject's incontinence status at 6 weeks and subsequent follow-up evaluations"}]}
{"nct_id":"NCT00251433","start_date":"2005-09-26","phase":"Phase 1","enrollment":53,"brief_title":"GW572016 With Docetaxel and Trastuzumab for the Treatment Of Untreated ErbB2 Over-Expressing Metastatic Breast Cancer","official_title":"An Open-label, Multicenter, Phase I/II Dose Escalation Study of Oral GW572016 in Combination With Docetaxel (Taxotere) Plus Trastuzumab (Herceptin) in Subjects Previously Untreated for ErbB2-overexpressing Metastatic Breast Cancer","primary_completion_date":"2010-06-10","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2021-12-31","last_update":"2021-01-08","description":"This study was designed to be two-part study (Phase I/Phase II). Part I was designed to find the optimal (best) doses of GW572016, docetaxel, and trastuzumab when given together, Part II was designed to evaluate the tumor response rate (shrinkage or lack of growth) in patients receiving all three drugs compared to patients receiving only docetaxel and trastuzumab. However, the phase II part was cancelled before it started. Participants were only enrolled in the phase I part and NOT the phase II part.","other_id":"EGF100161","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subjects must be 18 years of age.\r\n\r\n        Criteria for female subjects:\r\n\r\n          -  Non-child-bearing potential (i.e., women with functioning ovaries who have a current\r\n             documented tubal ligation or hysterectomy, or women who are post- menopausal);\r\n\r\n          -  Child-bearing potential (i.e., women with functioning ovaries and no documented\r\n             impairment of oviductal or uterine function that would cause sterility.) This category\r\n             includes women with oligomenorrhoea (severe), women who are perimenopausal, and young\r\n             women who have begun to menstruate. These subjects must have a negative serum\r\n             pregnancy test at screening and agree to one of the following:\r\n\r\n          -  Complete abstinence from intercourse from 2 weeks prior to administration of the first\r\n             dose of study medication until 28 days after the final dose of study medication; or\r\n\r\n          -  Consistent and correct use of one of the following acceptable methods of birth\r\n             control:\r\n\r\n          -  male partner who is sterile prior to the female subject's entry into the study and is\r\n             the sole sexual partner for that female subject; implants of levonorgestrel;\r\n             injectable progestogen; any intrauterine device (IUD) with a documented failure rate\r\n             of less than 1% per year; oral contraceptives (either combined or progestogen only);\r\n             or barrier methods, including diaphragm or condom with a spermicide.\r\n\r\n          -  Subjects must have an ECOG Performance Status of 0 to 1.\r\n\r\n          -  Subjects must have histologically- or cytologically-confirmed invasive breast cancer\r\n             with Stage IV disease.\r\n\r\n          -  Subjects must have measurable lesion(s) according to RECIST criteria for phase II,\r\n             however for phase I subjects evaluable disease will be allowed (including patients\r\n             with bone lesion only disease).\r\n\r\n          -  Prior to enrolment in the Phase I part of the study, subjects must have documentation\r\n             of ErbB2 over-expression via IHC3+ or FISH+ testing. Prior to enrolment in the Phase\r\n             II part of the study, subjects must have ErbB2 over-expression confirmed by a central\r\n             laboratory,\r\n\r\n          -  Subjects with stable CNS metastases or leptomeningeal involvement are eligible only if\r\n             they are not taking oral steroids or enzyme-inducing anticonvulsants. Subjects with\r\n             CNS only disease will not be allowed.\r\n\r\n          -  Subjects that received prior radiotherapy must have completed radiotherapy treatment\r\n             at least 4 weeks before enrolment and recovered from all treatment-related toxicities.\r\n\r\n          -  Subjects must have new or archived tumour tissue available prior to study entry to\r\n             evaluate levels of relevant biomarkers.\r\n\r\n          -  Subjects must have a cardiac ejection fraction within the institutional range of\r\n             normal as measured by Multigated Acquisition (MUGA) scan or echocardiogram (ECHO).\r\n\r\n          -  Subjects must have adequate haematological, hepatic, and renal function. Haemoglobin\r\n             9gm/dL Absolute granulocyte count 1500/mm (1.5 x 10^9/L) Platelets 75,000/mm (75\r\n             x 10^9/L) Total bilirubin 1.5mg/dL Both ALT and AST 1.5 times the upper limit of the\r\n             normal range (ULN) and alkaline phosphatase 2.5 times the ULN (See Taxotere Data\r\n             Sheet) Serum creatinine  2.0mg/dL or calculated creatinine clearance (CrCl) 40mL/min\r\n             according to the formula of Cockcroft and Gault\r\n\r\n          -  Subjects who received a taxane as part of adjuvant or neoadjuvant therapy are eligible\r\n             if they had progression of their disease more than 6 months after completion of\r\n             treatment.\r\n\r\n          -  Subjects who received prior ErbB inhibitors in the adjuvant setting will be allowed,\r\n             but a disease-free interval of at least 6 months must be demonstrated after the end of\r\n             therapy.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subject has peripheral neuropathy of grade 2 or higher;\r\n\r\n          -  Subject has had prior systemic therapy (except one line of hormonal therapy) for\r\n             metastatic disease. Also, any subjects with prior chemotherapy in the adjuvant or\r\n             neoadjuvant setting with anthracycline or anthracenedione-containing regimens with\r\n             cumulative doses of 360mg/m of doxorubicin, 720mg/m of epirubicin, or 72mg/m of\r\n             mitoxantrone;\r\n\r\n          -  Subjects with prior systemic investigational drugs within the past 30 days or topical\r\n             investigational drugs within the past 7 days;\r\n\r\n          -  Subjects with uncontrolled or symptomatic angina, arrhythmias, or congestive heart\r\n             failure;\r\n\r\n          -  Subjects with a known immediate or delayed hypersensitivity or untoward reaction to\r\n             docetaxel, trastuzumab, or other related compounds, or to drugs chemically related to\r\n             lapatinib. These include other aminoquinazolines, such as gefitinib (Iressa),\r\n             erlotinib (Tarceva), or other chemically-related compounds.\r\n\r\n          -  Subjects taking any prohibited medications\r\n\r\n          -  Subject neither affiliated with, nor beneficiary of a social security category (For\r\n             France only)\r\n      ","sponsor":"Novartis Pharmaceuticals","sponsor_type":"Industry","conditions":"Neoplasms, Breast","interventions":[{"intervention_type":"Drug","name":"Drug: lapatinib, docetaxel, trastuzumab","description":"The phase I part of the study will include cohorts of 3 patients to investigate doses of lapatinib (750mg, 1000mg, 1250mg, 1500mg) with 75mg/m2 3- weekly docetaxel plus standard weekly doses of trastuzumab with prophylactic use of growth factors in all patients. Further cohorts may be explored with prophylactic use of growth factors at the doses stipulated in the phase I dose escalation schema"},{"intervention_type":"Drug","name":"Drug: Docetaxel, trastuzumab","description":"For Phase II, subjects will be pre-stratified for Eastern Cooperative Oncology Group (ECOG) performance (0 vs. 1; see Appendix 4 ) and site of disease (visceral vs. non-visceral). Subjects will then be randomised in a 2:1 ratio to receive either the triplet regimen or the docetaxel and trastuzumab combination."}],"outcomes":[{"outcome_type":"primary","measure":"Phase I: Optimal doses and toleration of the three drugs administered together.","time_frame":"3 weeks"},{"outcome_type":"primary","measure":"Phase II: The primary efficacy endpoint is objective tumour response rate as measured by radiological imaging, photography, and/or physical examination performed every other cycle and recorded according to RECIST criteria.","time_frame":"3 weeks"},{"outcome_type":"secondary","measure":"Phase I and II Tumor response rate; Time to tumor response; Length of response; Time to progression of cancer; Overall survival.","time_frame":"6 weeks"},{"outcome_type":"secondary","measure":"PK endpoints: Cmin and Cmax; Concentrations of alpha-1 acid glycoprotein and albumin.","time_frame":"6 weeks"},{"outcome_type":"secondary","measure":"Safety and tolerability endpoints will consist of evaluation of AEs and changes from baseline in laboratory values.","time_frame":"6 weeks"},{"outcome_type":"secondary","measure":"Relevant biomarkers, including ErbB1, ErbB2, ErbB3, ErbB4, AKT, and potentially other biomarkers downstream from the ErbB1 and ErbB2 receptors, will be determined from tumour tissue.","time_frame":"6 weeks"},{"outcome_type":"secondary","measure":"Serum concentrations of ErbB1 and ErbB2 ECD will be correlated to tumour response.","time_frame":"6 weeks"}]}
{"nct_id":"NCT00254982","start_date":"2005-08-31","phase":"Phase 3","enrollment":593,"brief_title":"Infliximab in High Need Versus Low Need Psoriasis Patients: The IHELP Study (Study P04320)(COMPLETED)","official_title":"An Open-Label Study to Determine Equivalence in Efficacy, Organ Safety and Systemic Tolerability Between Infliximab in GROUP I (\"High Need\") and GROUP II (\"Low Need\") Patients Suffering From Chronic Plaque Psoriasis (Psoriasis Vulgaris)","primary_completion_date":"2006-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2006-09-30","last_update":"2015-10-12","description":"This is an open-label, multicenter, parallel-group comparison study of the efficacy, safety, and tolerability of infliximab therapy in adult patients suffering from chronic plaque psoriasis (psoriasis vulgaris). Patients will be assigned to GROUP I (\"high need\") or GROUP II (\"low-need\") by the investigator according to their previous psoriasis treatment.","other_id":"P04320","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Written informed consent by the patient for study participation, prior to protocol\r\n             specific procedures.\r\n\r\n          -  Patients who are 18 years of age or older at time of enrollment, may be male or female\r\n             and of any race.\r\n\r\n          -  Diagnosis of plaque-type psoriasis (psoriasis vulgaris) at least 6 months prior to\r\n             screening.\r\n\r\n          -  Plaque-type psoriasis covering at least 10% of total body surface area.\r\n\r\n          -  Psoriasis Area and Severity Index (PASI)-Score of 12 or greater.\r\n\r\n          -  GROUP I (\"high need\") patients: adult patients with moderate to severe plaque\r\n             psoriasis who are either not controlled by, or are intolerant to or have\r\n             contraindications to at least two currently available systemic therapies (e.g.\r\n             photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters,\r\n             efalizumab, etanercept). GROUP II (\"low need\") patients: adult patients with moderate\r\n             to severe plaque psoriasis who have undergone pre-treatment with no more than one\r\n             currently available systemic therapy (e.g. photochemotherapy, cyclosporine,\r\n             methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). A patient\r\n             showing contraindications towards two systemic treatments, who has never been\r\n             pretreated with a systemic therapy will be assigned to GROUP II (\"low need\").\r\n\r\n          -  Patients must have had a chest x-ray (preferably posteroanterior and lateral) within 3\r\n             months prior to first infusion with no evidence of malignancy, infection (e.g.\r\n             tuberculosis) or fibrosis.\r\n\r\n          -  Laboratory test results: liver enzymes (aspartate aminotransferase (AST), alanine\r\n             aminotransferase (ALT), gamma glutamyl transferase (GGT) and alkaline phosphatase)\r\n             must be within 1.5 times the upper limit of normal range (ULN), total bilirubin <=1.0\r\n             ULN, serum creatinine <1.5 mg/dL (must be available at Baseline).\r\n\r\n          -  Patients must agree to avoid prolonged sun exposure or other ultraviolet light sources\r\n             during the study.\r\n\r\n          -  Women of child-bearing potential must agree to use a medically accepted method of\r\n             contraception prior to screening, while receiving protocol-specified medication, and\r\n             for six months after stopping the medication. Acceptable methods of contraception\r\n             include abstinence, condoms (male or female) with or without a spermicidal agent,\r\n             diaphragm or cervical cap with spermicide, medically prescribed intrauterine device\r\n             (IUD), oral or injectable hormonal contraceptive, and surgical sterilization (e.g.\r\n             hysterectomy or tubal ligation).\r\n\r\n          -  Women of child-bearing potential must have a negative serum pregnancy test (beta-human\r\n             chorionic gonadotropin [hCG]) at Screening (must be available at Baseline).\r\n\r\n          -  Baseline PASI-Score of 12 or greater.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients suffering from active or latent tuberculosis. Prior to the start of treatment\r\n             with infliximab tuberculosis needs to be excluded following the recommendations\r\n             published by the German Paul Ehrlich Institute.\r\n\r\n          -  Patients who have had or have a serious infection (e.g. abscess, pneumonia or\r\n             pyelonephritis) or who have been hospitalized or received treatment with intravenous\r\n             antibiotics during the previous 2 months.\r\n\r\n          -  Patients who are known to be infected with human immunodeficiency virus, hepatitis B\r\n             or C virus, prior or current opportunistic infections (within the last six months,\r\n             Herpes zoster within the last 2 months).\r\n\r\n          -  Patients suffering from congestive heart failure including medically controlled\r\n             asymptomatic patients.\r\n\r\n          -  History of demyelinating disease or symptoms suggestive of multiple sclerosis or optic\r\n             neuritis.\r\n\r\n          -  Patients who have current signs and symptoms or history of systemic lupus\r\n             erythematosus.\r\n\r\n          -  Patients suffering from non-plaque psoriasis, e.g. erythrodermic, guttate or pustular\r\n             forms. The presence of psoriasis-arthritis is no exclusion criterion.\r\n\r\n          -  Patients suffering from current drug induced psoriasis (e.g. a new onset of psoriasis\r\n             or an exacerbation of psoriasis from beta-blockers or calcium-channel-blockers). If\r\n             the patient takes one of those substances on a regular basis, it should be on a stable\r\n             dose for at least three weeks prior to Baseline.\r\n\r\n          -  Patients suffering from severe, progressive or uncontrolled renal, hepatic,\r\n             hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral\r\n             or psychiatric diseases, that, in the opinion of the investigator, would interfere\r\n             with the study evaluations or safe or optimal participation in the study.\r\n\r\n          -  Any known malignancy during the last five years (except basal cell carcinoma), any\r\n             history of lymphoproliferative disease.\r\n\r\n          -  Patients who have received any systemic psoriasis therapy (e.g. immunosuppressant) or\r\n             lithium within 28 days or baseline visit.\r\n\r\n          -  Patients pretreated with etanercept or efalizumab within 28 days of Baseline.\r\n\r\n          -  Patients previously treated with infliximab.\r\n\r\n          -  Patients who have used topical treatments that could affect PASI evaluation (e.g.\r\n             corticosteroids, anthralin, topical vitamin D derivates) within 2 weeks of baseline\r\n             visit, except special areas like head or hands.\r\n\r\n          -  Patients who have used any investigational drug within 3 months of Baseline.\r\n\r\n          -  Patients with allergy/sensitivity to study drug or its excipients.\r\n\r\n          -  Women who are breast-feeding, pregnant, or intend to become pregnant.\r\n\r\n          -  Patients with any clinically significant condition or situation, other than the\r\n             condition being studied.\r\n\r\n          -  Patients who are participating in any other clinical study.\r\n\r\n          -  Patients who are part of the staff personnel directly involved with this study.\r\n\r\n          -  Patients who are a family member of the investigational study staff.\r\n\r\n          -  Patients who have used any investigational drug within 3 months before Baseline.\r\n\r\n          -  Patients who have received any systemic psoriasis therapy (e.g. immunosuppressants) or\r\n             lithium within 28 days of baseline visit.\r\n      ","sponsor":"Merck Sharp & Dohme Corp.","sponsor_type":"Industry","conditions":"Psoriasis","interventions":[{"intervention_type":"Biological","name":"Biological: Infliximab","description":"Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14."}],"outcomes":[{"outcome_type":"primary","measure":"Proportion of Participants Achieving a Greater Than or Equal to 75% Improvement in Psoriasis Area and Severity Index (PASI75) Score","time_frame":"Baseline and Week 22","description":"PASI75 response is defined as participants who achieved at least a 75% improvement in PASI score from Baseline to Week 22. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their responses to therapy. The PASI produces a numeric score that can range from 0 to 72 (the higher the number, the worse the disease)."}]}
{"nct_id":"NCT00135655","start_date":"2005-08-31","phase":"Phase 2","enrollment":0,"brief_title":"A Study of Denufosol Tetrasodium Intravitreal Injection in Subjects With Post Cataract Extraction Macular Edema","official_title":"A Randomized, Double-Masked, Parallel, Group, Multi-Center, Dose Ranging Pilot Study of Denufosol Tetrasodium (INS37217) Intravitreal Injection in Subjects With Post Cataract Extraction Macular Edema","study_type":"Interventional","rec_status":"Withdrawn","last_update":"2013-05-21","description":"The purpose of this study is to investigate the safety and tolerability of three dose strengths of the study drug in subjects with post cataract extraction macular edema.","other_id":"06-104","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Have persistent post cataract extraction macular edema whose condition is stable\r\n\r\n          -  Have no change in medication regimen of immunosuppressive or anti-inflammatory agents;\r\n             steroidal or non-steroidal agents for a specified period of time prior to\r\n             randomization\r\n\r\n          -  Have at least one eligible eye to be treated in the study\r\n\r\n          -  Have an optical coherence tomography (OCT) scan with a qualifying retinal thickness in\r\n             the study eye\r\n\r\n          -  Have macular edema confirmed by fluorescein angiography\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Have proliferative vitreoretinopathy greater than grade B in either eye\r\n\r\n          -  Have ocular disorders in the study eye that may confound interpretation of study\r\n             results\r\n\r\n          -  Have ophthalmic disorders in the study eye that may influence final visual acuity\r\n             and/or fluorescein angiography interpretation\r\n\r\n          -  Have had cataract surgery in the study eye in the past 2 months, YAG laser capsulotomy\r\n             within the past 1 month, or any other intraocular surgery within the past 90 days\r\n\r\n          -  Have uncontrollable elevated intraocular pressure (IOP) or advanced glaucoma\r\n\r\n          -  Have had any periocular or intravitreal injection of corticosteroids in the study eye\r\n             within 3 months\r\n\r\n          -  Have had any ocular implant device for the delivery of therapeutic agents\r\n\r\n          -  Be taking any excluded medications that could obscure or confound study results\r\n      ","sponsor":"Merck Sharp & Dohme Corp.","sponsor_type":"Industry","conditions":"Macular Edema, Cystoid","interventions":[{"intervention_type":"Drug","name":"Drug: denufosol tetrasodium (INS37217) Intravitreal Injection"}],"outcomes":[{"outcome_type":"primary","measure":"safety"},{"outcome_type":"primary","measure":"tolerability"},{"outcome_type":"primary","measure":"retinal thickness"},{"outcome_type":"primary","measure":"visual acuity"}]}
{"nct_id":"NCT00138385","start_date":"2005-08-31","phase":"Phase 4","enrollment":40,"brief_title":"Comparison of Inactivated and Live, Attenuated Influenza Vaccine in Children 5-9 Years of Age-Year 3 Amendment","official_title":"A Randomized Comparison of the Immune Response to Either Inactivated or Live, Attenuated Influenza Vaccine in Children 5-9 Years of Age","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-06-30","last_update":"2010-08-27","description":"The purpose of this study is to evaluate how young children's bodies learn to fight against flu infection and to see how vaccines may help to fight against the flu. This is a Phase 4, single-center, randomized study of the immune responses of 40 children, ages 5-9, given one of two licensed influenza vaccines (either inactivated vaccine given in an arm muscle or live, attenuated vaccine inhaled through the nose). Study procedures will include up to 3 blood samples. Participants will complete a diary to document any side effects experienced following the vaccination. Participants will return to the clinic for a visit on Day 7-9 and again 4-6 weeks following vaccination. Participants that have not been previously vaccinated will receive a 2nd dose of vaccine. A follow up telephone call will occur 8-10 weeks following vaccination. Total study participation will be up to 75 days.","other_id":"04-079","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":5,"maximum_age":9,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy children aged 5-9 years of age.\r\n\r\n          -  Parents willing to sign informed consent.\r\n\r\n          -  Availability for follow-up for the planned duration of the study at least 4 weeks\r\n             after last immunization.\r\n\r\n          -  Acceptable medical history by screening evaluation and brief clinical assessment.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of immunodeficiency.\r\n\r\n          -  Known or suspected impairment of immunologic function including, but not limited to,\r\n             clinically significant liver disease; diabetes mellitus; moderate to severe kidney\r\n             impairment.\r\n\r\n          -  Household contact with immunodeficiency due to disease, medication or radiation.\r\n\r\n          -  Child receiving aspirin therapy or aspirin-containing therapy.\r\n\r\n          -  History of Guillain-Barr syndrome.\r\n\r\n          -  Malignancy, other than squamous cell or basal cell skin cancer.\r\n\r\n          -  Autoimmune disease.\r\n\r\n          -  History of asthma or reactive airways disease.\r\n\r\n          -  Chronic cardiovascular and pulmonary disorder.\r\n\r\n          -  Chronic metabolic diseases (including diabetes), renal dysfunction or\r\n             hemoglobinopathies requiring regular medical follow-up or hospitalization during the\r\n             preceding year.\r\n\r\n          -  Use of immunosuppressive medication. Corticosteroid nasal sprays are permissible.\r\n\r\n          -  Medical or psychiatric condition or occupational responsibilities that preclude\r\n             subject compliance with the protocol.\r\n\r\n          -  Inactivated vaccine 14 days prior to vaccination.\r\n\r\n          -  Live, attenuated vaccines within 60 days of study.\r\n\r\n          -  Use of investigational agents within 30 days prior to study.\r\n\r\n          -  Receipt of blood products or immunoglobulin in the past 6 months.\r\n\r\n          -  Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment.\r\n\r\n          -  Acute febrile illness on the day of vaccination.\r\n\r\n          -  Known allergies to any component of the vaccine, including thimerosal.\r\n\r\n          -  History of allergy to eggs or egg products.\r\n\r\n          -  Any condition that, in the opinion of the investigator, might interfere with study\r\n             objectives.\r\n      ","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","sponsor_type":"NIH","conditions":"Influenza","interventions":[{"intervention_type":"Biological","name":"Biological: FluMist"},{"intervention_type":"Biological","name":"Biological: Fluzone"}],"outcomes":{}}
{"nct_id":"NCT00262899","start_date":"2005-08-31","phase":"Phase 3","enrollment":331,"brief_title":"Genetic Counseling or Usual Care in Helping Women With Newly Diagnosed Ductal Carcinoma In Situ or Stage I, Stage II, or Stage IIIA Breast Cancer Make Treatment Decisions","official_title":"Genetic Counseling for Newly Diagnosed Breast Cancer Patients","primary_completion_date":"2010-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-07-31","last_update":"2013-01-07","description":"RATIONALE: Genetics education and counseling may help patients make treatment decisions. It is not yet known how genetic counseling or usual care influence patient treatment decisions for breast cancer. PURPOSE: This randomized clinical trial is studying how well genetic counseling works compared to usual care in helping patients with newly diagnosed ductal carcinoma in situ, stage I, stage II, or stage IIIA breast cancer make treatment decisions.","other_id":"CDR0000450155","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        DISEASE CHARACTERISTICS:\r\n\r\n          -  Newly diagnosed breast cancer, meeting 1 of the following criteria:\r\n\r\n               -  Stage 0 disease (ductal carcinoma in situ only)\r\n\r\n               -  Stage I-IIIA disease\r\n\r\n          -  Must meet 1 of the following criteria:\r\n\r\n               -  Diagnosis before 50 years of age\r\n\r\n               -  Diagnosis after 50 years of age AND has 1 of the following:\r\n\r\n                    -  First or second degree relative diagnosed with breast cancer before 50 years\r\n                       of age\r\n\r\n                    -  First or second degree relative diagnosed with ovarian cancer at any age\r\n\r\n                    -  First or second degree relative diagnosed with male breast cancer at any age\r\n\r\n          -  Must not have initiated definitive treatment for breast cancer\r\n\r\n          -  No bilateral, metastatic, or inflammatory breast cancer\r\n\r\n          -  No prior BRCA1/2 counseling or testing\r\n\r\n          -  No prior diagnosis of metastatic cancer of any type\r\n\r\n          -  Hormone receptor status:\r\n\r\n               -  Not specified\r\n\r\n        PATIENT CHARACTERISTICS:\r\n\r\n        Sex\r\n\r\n          -  Female\r\n\r\n        Menopausal status\r\n\r\n          -  Not specified\r\n\r\n        Performance status\r\n\r\n          -  Not specified\r\n\r\n        Life expectancy\r\n\r\n          -  Not specified\r\n\r\n        Hematopoietic\r\n\r\n          -  Not specified\r\n\r\n        Hepatic\r\n\r\n          -  Not specified\r\n\r\n        Renal\r\n\r\n          -  Not specified\r\n\r\n        PRIOR CONCURRENT THERAPY:\r\n\r\n        Surgery\r\n\r\n          -  No prior bilateral mastectomy for breast cancer\r\n\r\n        Other\r\n\r\n          -  No concurrent treatment for cancer\r\n      ","sponsor":"Georgetown University","sponsor_type":"Other","conditions":"Breast Cancer|Psychosocial Effects of Cancer and Its Treatment","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: counseling intervention"},{"intervention_type":"Other","name":"Other: educational intervention"},{"intervention_type":"Procedure","name":"Procedure: psychosocial assessment and care"}],"outcomes":[{"outcome_type":"primary","measure":"Definitive surgery choice as measured by self-reported and medical record verification at 6 months after randomization","time_frame":"1, 6, and 12 months"},{"outcome_type":"primary","measure":"Quality of life as measured by functional assessment of cancer therapy for breast cancer (FACT-B) at 1, 6, and 12 months after randomization","time_frame":"1, 6, and 12 months"},{"outcome_type":"primary","measure":"Distress as measured by Impact of Events Scale Brief Symptom Inventory at 1, 6, and 12 months after randomization","time_frame":"1, 6, and 12 months"},{"outcome_type":"primary","measure":"Knowledge as assessed by Genetic Testing Knowledge Measure at 1 month after randomization","time_frame":"1 month"},{"outcome_type":"primary","measure":"Decision outcomes as assessed by Decisional Conflict Scale Satisfaction with Decision Scale at 1 and 6 months after randomization","time_frame":"1 and 6 months"},{"outcome_type":"secondary","measure":"Cost effectiveness as measured by quality adjusted life years saved at 12 months after randomization","time_frame":"12 months"}]}
{"nct_id":"NCT00305370","start_date":"2005-08-31","phase":"Phase 4","enrollment":20,"brief_title":"Aripiprazole Associated With Methylphenidate in Children and Adolescents With Bipolar Disorder and ADHD","official_title":"Aripiprazole Associated With Methylphenidate in Children and Adolescents With Bipolar Disorder and ADHD: A Randomized Cross-Over Placebo Controlled Trial","primary_completion_date":"2008-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-03-31","last_update":"2008-08-07","description":"There is a scarcity of clinical trials assessing the effects of medications in children with bipolar disorder. This study aims to assess the efficacy of Aripiprazole associated with Methylphenidate (MPH)for the treatment of children and adolescents with bipolar disorder comorbid with ADHD who improve in maniac symptoms while receiving aripiprazole but did not have an adequate response in ADHD symptoms. The study design is a 4-week randomized, double blind, cross-over group trial. Patients were randomized to aripiprazole + MPH or aripiprazole + placebo. The main hypothesis is: Aripiprazole + MPH will significantly reduce ADHD scores compared to aripiprazole + placebo.","other_id":"GPPG03-325b","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":8,"maximum_age":17,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age: 8 -17\r\n\r\n          -  BD type I or II comorbid with ADHD\r\n\r\n          -  Reduction of maniac symptoms (30% reduction in the YMRS scores and/or CGI scores \r\n             2)while using aripiprazole during a previous study (NCT00116259)without improvement of\r\n             ADHD symptoms (reduction in ADHD symptoms < 30% in the SNAP-IV). Those receiving\r\n             placebo in the previous protocol will receive a 6- week open label treatment with\r\n             aripiprazole. The same threshold for reducing maniac symptoms and absence of response\r\n             in ADHD symptoms will be used.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  IQ < 70\r\n\r\n          -  Pregnancy or absence of a contraceptive method in fertile girls\r\n\r\n          -  Diagnoses: pervasive development disorder, schizophrenia, drug abuse or dependency\r\n\r\n          -  Risk of suicide or homicide\r\n\r\n          -  Clinical condition that might interfere in the study\r\n\r\n          -  Known sensibility to aripiprazole\r\n      ","sponsor":"Federal University of Rio Grande do Sul","sponsor_type":"Other","conditions":"Bipolar Disorder|Attention Deficit Hyperactivity Disorder","interventions":[{"intervention_type":"Drug","name":"Drug: Aripiprazole"}],"outcomes":[{"outcome_type":"primary","measure":"Scores in the SNAP-IV (ADHD)"},{"outcome_type":"primary","measure":"Scores in the Young Mania Rating Scale (BD)"},{"outcome_type":"primary","measure":"Weight"},{"outcome_type":"secondary","measure":"Scores in CGI"},{"outcome_type":"secondary","measure":"Scores in the CMRS-P"},{"outcome_type":"secondary","measure":"Scores in the CDRS"},{"outcome_type":"secondary","measure":"Scores in the Kutcher Adolescent Depression Scale"},{"outcome_type":"secondary","measure":"Scores of quality of life (YQOL-R)"},{"outcome_type":"secondary","measure":"Report of side events"}]}
{"nct_id":"NCT02537990","start_date":"2005-08-31","enrollment":1200,"brief_title":"MDS-CAN: A Prospective National MDS Clinical Database and Local Tissue Bank","official_title":"MDS-CAN: A Prospective National MDS Clinical Database and Local Tissue Bank","primary_completion_date":"2020-02-29","study_type":"Observational [Patient Registry]","rec_status":"Unknown status","completion_date":"2020-02-29","last_update":"2016-11-16","description":"The purposes of this study are: 1. To identify and quantify the health utilities and quality of life experienced by patients who have been diagnosed with MDS and what are their predictors. 2. Measure the effects of patient related factors like frailty and comorbidity on quality of life and overall survival or toxicity to therapy. 3. Assess how quality of life changes over time and what are its predictors. This will be valuable information that may guide therapy, transfusion practices, etc., as MDS is a chronic, incurable disease that is often progressive.","other_id":"MDS Database","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":19,"population":"Primary care clinic, referrals from community physicians.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  New diagnosis of a Myelodysplastic syndrome\r\n\r\n          -  New diagnosis of CMML-1/CMML-2 and MDS/MPN\r\n\r\n          -  New diagnosis of low blast AML (blasts 20-30%) as defined by the WHO classification\r\n             (Vardiman, 2002)\r\n\r\n          -  Greater than 18 years of age at the time of diagnosis\r\n\r\n          -  Able to read, write and speak English or French (non-English or French speaking\r\n             patients may participate if appropriate translation is used)\r\n\r\n          -  Able to consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients whose diagnostic bone marrow exceed 2 years prior signing consent\r\n\r\n          -  Subjects with AML and bone marrow blast of 31% or more at the time of signing consent\r\n\r\n          -  Prior allogenic cell transplant\r\n      ","sponsor":"Sunnybrook Health Sciences Centre","sponsor_type":"Other","conditions":"Myelodysplastic Syndrome (MDS)","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"quality of life","time_frame":"every 6 months up to 6 years"}]}
{"nct_id":"NCT00566683","start_date":"2005-07-31","phase":"N/A","enrollment":194,"brief_title":"Comparison Between Nurse-Administered Propofol Sedation and Diazemuls / Pethidine in Outpatient Colonoscopy","official_title":"Nurse-Administered Propofol Sedation by PCA Pump Versus Diazemuls / Pethidine in Outpatient Colonoscopy: A Randomized Controlled Study","study_type":"Interventional","rec_status":"Completed","completion_date":"2006-06-30","last_update":"2007-12-03","description":"Colonoscopy is a common endoscopic procedure as an investigation of colorectal pathology. Different modalities of pain control have been described in the past. Propofol is a perfect drug for endoscopic procedure since it has the characteristic of fast onset, short half-life and early recovery. Its unfamiliarity and its potential cardiovascular and respiratory side effect make it unpopular to endoscopists. Recent reports showed propofol is safe in bolus titration by nurse in Caucasian in all endoscopic procedures. Our previous pilot study showed nurse administered propofol sedation (NAPS) is effective and safe and highly acceptable by Chinese patients. Here we conduct a randomized controlled study to compare the effectiveness of NAPS versus traditional sedation.","other_id":"CRE-2005.010-T","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age 18-65 undergoing elective outpatient colonoscopy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  American Society of Anesthesiologist Class III or above\r\n\r\n          -  History of difficult endotracheal intubation\r\n\r\n          -  Known allergy to propofol, eggs or soy products, opioid, benzodiazepines\r\n\r\n          -  previous colectomy\r\n      ","sponsor":"North District Hospital","sponsor_type":"Other","conditions":"Colonoscopy","interventions":[{"intervention_type":"Drug","name":"Drug: diazemuls, pethidine","description":"5mg Diazemuls and 25mg Pethidine one min. before procedure followed by bolus doses of 2.5mg Diazemuls / 12.5mg Pethidine at the discretion of endoscopists Maximal dose of 0.2mg/kg Diazemuls and 1mg/kg Pethidine"},{"intervention_type":"Drug","name":"Drug: Propofol and Alfentanil","description":"Loading dose of 40-60mg or 0.8mg/kg Propofol one min. before procedure Propofol 200mg + Alfentanil 0.5mg, 1.5ml per bolus (bolus dose of 14.3mg Propofol + 35ug Alfentanil) via PCA pump No maximal dose Zero lockout time"}],"outcomes":[{"outcome_type":"primary","measure":"Pain","time_frame":"after recovery"},{"outcome_type":"secondary","measure":"sedation","time_frame":"thorughout the procedure"}]}
{"nct_id":"NCT00172809","start_date":"2005-07-31","phase":"Phase 4","enrollment":50,"brief_title":"Interferon Treatment for Patients With Chronic Hepatitis C and End Stage Renal Disease","official_title":"A Pilot Study in Comparing the Efficacy and Safety of Peginterferon Alfa-2a and Interferon Alfa-2a in Treating Patients With End Stage Renal Disease and Chronic Hepatitis C","primary_completion_date":"2006-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-01-31","last_update":"2008-03-06","description":"The treatment response with conventional interferon alpha alone in patients with end stage renal disease and chronic hepatitis C is about 33-39%. However, the drop-out rate is 17-29.6%. Pegylated interferon alpha, a newly developed form of interferon with superior pharmacokinetic profiles, has not been used to treatment these patients. We expect the better treatment response treated with peginterferon alpha than conventional interferon. In addition, we also observe the safety of the two drugs during the study. The goal of the study is to compare the efficacy and safety of the two different treatment regimens in patients with chronic hepatitis C and end stage renal disease.","other_id":"940209","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age between 18 to 65 years old\r\n\r\n          -  Creatinine clearance (Ccr) < 10 ml/min/1.73 m2\r\n\r\n          -  Receiving regular hemodialysis\r\n\r\n          -  Anti-HCV (Abbott HCV EIA 2.0, Abbott Diagnostic, Chicago, IL) positive > 6 months\r\n\r\n          -  Detectable serum HCV-RNA (Cobas Amplicor HCV Monitor v2.0, Roche Molecular Systems,\r\n             Pleasanton, CA) with dynamic range 600~<500,000 IU/ml\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Neutropenia (neutrophil count, <1,500/mm3)\r\n\r\n          -  Thrombocytopenia (platelet <90,000/ mm3)\r\n\r\n          -  Co-infection with HBV or HIV\r\n\r\n          -  Chronic alcohol abuse (daily consumption > 20 g/day)\r\n\r\n          -  Decompensated liver disease (Child classification B or C)\r\n\r\n          -  Neoplastic disease\r\n\r\n          -  An organ transplant\r\n\r\n          -  Immunosuppressive therapy\r\n\r\n          -  Poorly controlled autoimmune diseases, pulmonary diseases, cardiac diseases,\r\n             psychiatric diseases, neurological diseases, diabetes mellitus\r\n\r\n          -  Evidence of drug abuse\r\n\r\n          -  Unwilling to have contraception\r\n      ","sponsor":"National Taiwan University Hospital","sponsor_type":"Other","conditions":"Chronic Hepatitis C|End Stage Renal Disease","interventions":[{"intervention_type":"Drug","name":"Drug: Peginterferon alfa-2a","description":"Peginterferon alfa-2a 135 ug/week for 24 weeks"},{"intervention_type":"Drug","name":"Drug: Interferon alfa-2a","description":"Interferon alfa-2a 3 MU tiw for 24 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Sustained histological response and sustained virological response 6 months after the completion of the intervention","time_frame":"1 year"},{"outcome_type":"secondary","measure":"The overall tolerance of the two different regimens and the comparison of the rates of side effects","time_frame":"1 year"}]}
{"nct_id":"NCT02170571","start_date":"2005-07-31","phase":"Phase 1","enrollment":24,"brief_title":"Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Dabigatran Etexilate in Patients With Moderate Hepatic Impairment Compared to Subjects With Normal Hepatic Function","official_title":"Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of 150 mg Dabigatran Etexilate p.o. in Patients With Moderate Hepatic Impairment Compared to Subjects With Normal Hepatic Function in a Monocentric, Open, Parallel-group Design","primary_completion_date":"2005-12-31","study_type":"Interventional","rec_status":"Completed","last_update":"2014-06-23","description":"Assessment of the effect of moderate liver impairment (Child-Pugh classification B) on the pharmacokinetics and pharmacodynamics of dabigatran after oral administration of dabigatran etexilate. Determination of safety and tolerability of dabigatran upon administration to hepatically impaired patients and healthy subjects (matched pairs)","other_id":"1160.51","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy age-, weight-, and sex-matched subjects determined by results of screening\r\n             with normal hepatic function (group 1)\r\n\r\n          -  Hepatically impaired subjects determined by results of screening classified as\r\n             Child-Pugh B (group 2)\r\n\r\n          -  Signed written informed consent in accordance with Good Clinical Practice (GCP) and\r\n             local legislation\r\n\r\n          -  Age >=18 and <=75 years\r\n\r\n          -  BMI >=18.0 and <=32 kg/m2, at least 45 kg for females\r\n\r\n          -  Creatinine clearance >80 mL/min according to Cockcroft & Gault\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Healthy subjects (Group 1) who met any of the following criteria should not be entered\r\n             into this trial:\r\n\r\n               -  Any finding of the medical examination (including blood pressure, pulse rate, and\r\n                  electrocardiogram) deviating from normal and of clinical relevance\r\n\r\n               -  Clinically relevant gastrointestinal, hepatic, renal, respiratory,\r\n                  cardiovascular, metabolic, immunologic or hormonal disorders\r\n\r\n               -  Surgery of gastrointestinal tract (except appendectomy, cholecystectomy,\r\n                  herniotomy)\r\n\r\n               -  Clinically relevant diseases of the central nervous system\r\n\r\n               -  Relevant history of orthostatic hypotension, fainting spells or blackouts\r\n\r\n               -  Evidence of blood dyscrasia, haemorrhagic diathesis, severe thrombocytopenia,\r\n                  cerebrovascular haemorrhage, bleeding tendencies associated with active\r\n                  ulceration or overt bleeding of gastrointestinal, respiratory or genitourinary\r\n                  tract or any disease or condition with haemorrhagic tendencies (e.g. cerebral\r\n                  aneurysm, dissecting aorta, central nervous system (CNS) trauma, retinopathy,\r\n                  nephrolithiasis)\r\n\r\n               -  Recent or contemplated diagnostic or therapeutic procedures with potential for\r\n                  uncontrollable bleeding (e.g. spinal puncture, lumbar block anaesthesia, surgery\r\n                  of CNS or eye or surgery resulting in large open surfaces) within 14 days before\r\n                  or after drug administration of this clinical trial\r\n\r\n               -  Chronic or relevant acute infections\r\n\r\n               -  History of allergy/hypersensitivity (including drug allergy), which is deemed\r\n                  relevant to the trial as judged by the investigator\r\n\r\n               -  For women with childbearing potential: no reliable contraception (accepted\r\n                  methods are intra-uterine device, hormonal contraceptives, bilateral tubal\r\n                  ligation, hysterectomy, condoms) or pregnancy (known or detected by a positive\r\n                  pregnancy test) or breast feeding period\r\n\r\n               -  Intake of drugs with a long half-life (> 24 hours) (< 1 month prior to\r\n                  administration or during the trial)\r\n\r\n               -  Use of any drugs, within 14 days prior to administration or during the trial\r\n\r\n               -  Participation in another trial with an investigational drug (< 2 months prior to\r\n                  administration or during trial)\r\n\r\n               -  Drug abuse\r\n\r\n               -  Blood donation or loss > 400 ml, < 1 month prior to administration or during the\r\n                  trial\r\n\r\n               -  Excessive physical activities < 5 days prior to administration of study drug or\r\n                  during the trial\r\n\r\n               -  Clinically relevant laboratory abnormalities\r\n\r\n               -  Veins unsuited for i.v. puncture and administration of prolonged infusions on\r\n                  either arm (e.g. veins which are difficult to locate, access or puncture, veins\r\n                  with a tendency to rupture during or after puncture, etc.)\r\n\r\n          -  Hepatically impaired subjects (Group 2) who met any of the following criteria should\r\n             not be entered into this trial:\r\n\r\n               -  Moderate and severe concurrent renal function impairment (e.g., due to\r\n                  hepato-renal syndrome)\r\n\r\n               -  Clinically relevant gastrointestinal, respiratory, cardiovascular, metabolic,\r\n                  immunologic or hormonal disorders\r\n\r\n               -  Surgery of gastrointestinal tract (except appendectomy, cholecystectomy,\r\n                  herniotomy)\r\n\r\n               -  Clinically relevant diseases of the central nervous system\r\n\r\n               -  Relevant history of orthostatic hypotension, fainting spells or blackouts\r\n\r\n               -  Evidence of blood dyscrasia, haemorrhagic diathesis, severe thrombocytopenia,\r\n                  cerebrovascular haemorrhage, bleeding tendencies associated with active\r\n                  ulceration or overt bleeding of gastrointestinal, respiratory or genitourinary\r\n                  tract or any disease or condition with haemorrhagic tendencies (e.g. cerebral\r\n                  aneurysm, dissecting aorta, CNS trauma, retinopathy, nephrolithiasis) considered\r\n                  by the investigator or one of the coinvestigators to be clinically relevant\r\n\r\n               -  Recent or contemplated diagnostic or therapeutic procedures with potential for\r\n                  uncontrollable bleeding (e.g. spinal puncture, lumbar block anaesthesia, surgery\r\n                  of CNS or eye or surgery resulting in large open surfaces) within 14 days before\r\n                  or after drug administration of this clinical trial\r\n\r\n               -  History of allergy/hypersensitivity (including drug allergy) which is deemed\r\n                  relevant to the trial as judged by the investigator\r\n\r\n               -  For women with childbearing potential: no reliable contraception (accepted\r\n                  methods are intra-uterine device, hormonal contraceptives, bilateral tubal\r\n                  ligation, hysterectomy, condoms) or pregnancy (known or detected by a positive\r\n                  pregnancy test) or breast feeding period\r\n\r\n               -  Use of any drugs which have an influence on the blood clotting within 14 days\r\n                  prior to administration or during the trial\r\n\r\n               -  Participation in another trial with an investigational drug (< 2 months prior to\r\n                  administration or during trial)\r\n\r\n               -  Blood donation or loss > 400 ml, < 1 month prior to administration or during the\r\n                  trial\r\n\r\n               -  Excessive physical activities < 5 days prior to administration of study drug or\r\n                  during the trial\r\n\r\n               -  Clinically relevant laboratory abnormalities (except for liver function tests\r\n                  according to Child-Pugh classification), constellation of blood clotting\r\n                  parameters according to the judgment of the investigator\r\n\r\n               -  Veins unsuited for i.v. puncture and administration of prolonged infusions on\r\n                  either arm (e.g. veins which are difficult to locate, access or puncture, veins\r\n                  with a tendency to rupture during or after puncture, etc.)\r\n      ","sponsor":"Boehringer Ingelheim","sponsor_type":"Industry","conditions":"Hepatic Insufficiency","interventions":[{"intervention_type":"Drug","name":"Drug: Dabigatran etexilate"}],"outcomes":[{"outcome_type":"primary","measure":"AUC0-infinity (area under the concentration time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)","time_frame":"pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours"},{"outcome_type":"primary","measure":"Cmax (maximum concentration of the analyte in plasma)","time_frame":"pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours"},{"outcome_type":"primary","measure":"CL/F (apparent clearance of the analyte in the plasma after extravascular administration)","time_frame":"pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h"},{"outcome_type":"primary","measure":"concentration-response relationship of dabigatran assessed by analysis of activated partial thromboplastin time (aPTT), ecarin clotting time (ECT) , prothrombin time (PT) expressed as international normalised ratio (INR), and thrombin time (TT)","time_frame":"pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h"},{"outcome_type":"secondary","measure":"AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)","time_frame":"pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h"},{"outcome_type":"secondary","measure":"AUCt1-t2 (Area under the concentration time curve of the analyte in plasma over the time interval t1 to t2)","time_frame":"pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h"},{"outcome_type":"secondary","measure":"tmax (time from dosing to the maximum concentration of the analyte in plasma)","time_frame":"pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h"},{"outcome_type":"secondary","measure":"λz ( terminal rate constant in plasma)","time_frame":"pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h"},{"outcome_type":"secondary","measure":"t1/2 ( terminal half-life of the analyte in plasma)","time_frame":"pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h"},{"outcome_type":"secondary","measure":"MRTpo (mean residence time of the analyte in the body after oral administration)","time_frame":"pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h"},{"outcome_type":"secondary","measure":"Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)","time_frame":"pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h"},{"outcome_type":"secondary","measure":"Ae0-72 (amount of analyte that is eliminated in urine from the time interval 0 to 72 h)","time_frame":"pre-dose over 12 h from day -1 till day 1 and post-dose from day 1 till day 4 in fractions of 0 - 12, 12 - 24, 24 - 48 and 48 - 72 h"},{"outcome_type":"secondary","measure":"fe0-72 (fraction of administered drug excreted unchanged in urine from time point 0 to 72 h)","time_frame":"pre-dose over 12 h from day -1 till day 1 and post-dose from day 1 till day 4 in fractions of 0 - 12, 12 - 24, 24 - 48 and 48 - 72 h"},{"outcome_type":"secondary","measure":"CLR,0-72 (renal clearance of the analyte in plasma from the time point 0 h until the time point 72 h)","time_frame":"pre-dose over 12 h from day -1 till day 1 and post-dose from day 1 till day 4 in fractions of 0 - 12, 12 - 24, 24 - 48 and 48 - 72 h"},{"outcome_type":"secondary","measure":"Plasma protein binding of dabigatran","time_frame":"before drug administration"},{"outcome_type":"secondary","measure":"Change in pulse rate","time_frame":"up to day 4"},{"outcome_type":"secondary","measure":"Change in systolic and diastolic blood pressure","time_frame":"up to day 4"},{"outcome_type":"secondary","measure":"Change in ECG","time_frame":"up to day 4"},{"outcome_type":"secondary","measure":"Occurrence of adverse events","time_frame":"up to Day 4"},{"outcome_type":"secondary","measure":"Assessment of tolerability by investigator on a four-point scale","time_frame":"up to day 4"}]}
{"nct_id":"NCT02149602","start_date":"2005-07-31","enrollment":120,"brief_title":"A Phase II Study of Parotid-gland Sparing IMRT in Patients With Midline Tumour of the Head and Neck","official_title":"A Phase II Study of Parotid-gland Sparing Intensity-modulated Radiotherapy in Patients With Midline Tumour of the Head and Neck","primary_completion_date":"2011-11-30","study_type":"Observational","rec_status":"Completed","completion_date":"2014-01-31","last_update":"2014-05-29","description":"This study is a phase II trial designed to test the feasibility of delivering IMRT to head and neck cancer patients with tumours arising in the midline (oropharynx and hypopharynx), and to assess possible improvement in reducing the incidence of xerostomia with bilateral superficial lobe parotid sparing IMRT.","other_id":"CCR 2588","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Midline pharyngeal squamous cell cancers (excluding nasopharyngeal cancers)","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  histologically confirmed locally advanced HNSCC arising from the oropharynx or\r\n             hypopharynx with high risk of bilateral parapharyngeal space involvement\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients <18 years old or with a previous malignancy other than non-melanomatous skin\r\n             cancer\r\n      ","sponsor":"Royal Marsden NHS Foundation Trust","sponsor_type":"Other","conditions":"Oropharyngeal Squamous Cell Cancer|Hypopharyngeal Squamous Cell Cancer","interventions":[{"intervention_type":"Radiation","name":"Radiation: Intensity modulated radiotherapy","description":"Bilateral superficial lobe parotid sparing intensity modulated radiotherapy"}],"outcomes":[{"outcome_type":"primary","measure":"The proportion of patients reporting grade 2 or more xerostomia using subjective measure on the LENTSOMA late toxicity scoring scale one year after treatment.","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Acute radiation toxicity","time_frame":"0-3 months"},{"outcome_type":"secondary","measure":"Late radiation toxicity","time_frame":"3-24 months"},{"outcome_type":"secondary","measure":"Survival outcomes for entire cohort and according to HPV status where available : Local control, Loco regional control, Loco-regional progression-free survival (LRPFS), Disease free survival, Overall survival.","time_frame":"24 months"}]}
{"nct_id":"NCT00392782","start_date":"2005-07-31","phase":"Phase 2","enrollment":24,"brief_title":"Donor Stem Cell Transplant in Treating Patients With Myeloid Cancer or Other Disease","official_title":"A Multicenter, Prospective Trial to Evaluate the Role of NK Cell KIR Epitope Mismatch on Mortality and Disease Relapse in T-Cell Depleted Hematopoietic Stem Cell Transplantation From HLA-C Mismatched, Unrelated Donors for Myeloid Malignancies","primary_completion_date":"2011-05-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2011-05-31","last_update":"2017-12-28","description":"RATIONALE: Giving total-body irradiation and chemotherapy, such as fludarabine and thiotepa, before a donor stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving antithymocyte globulin and removing the T cells from the donor cells before transplant may stop this from happening. PURPOSE: This phase II trial is studying how well a donor stem cell transplant works in treating patients with myeloid cancer or other disease.","other_id":"2004UC035","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Primary acute myeloid leukemia (AML)\r\n\r\n               -  First complete remission (CR) with high risk features as defined by: failure to\r\n                  achieve remission by day 21 after induction chemotherapy, or the presence of\r\n                  chromosomal abnormalities involving any of the following: -5/de (5q), -7/del(7q),\r\n                  inversion 3q, abnormalities of 11q23, 20q, 21q, del(9q), translocation 6;9,\r\n                  translocation 9;22, abnormalities of 17p, or complex karyotype with > or = 3\r\n                  abnormalities. Complete remission is defined as < 5% blasts in the marrow.\r\n\r\n               -  Second CR or subsequent in remission\r\n\r\n               -  Refractory or relapsed disease with absolute peripheral blood blasts < 2000/mcL\r\n\r\n          -  Secondary AML in remission or relapse\r\n\r\n          -  Chronic myelogenous leukemia (CML) in accelerated or blast phase\r\n\r\n               -  Accelerated phase is defined by any one of the following:\r\n\r\n                    -  Blasts 10% to 19% of peripheral blood white cells or bone marrow cells\r\n\r\n                    -  Peripheral blood basophils at least 20%\r\n\r\n                    -  Persistent thrombocytopenia (<100 x 10^9/L) unrelated to therapy, or\r\n                       persistent thrombocytosis (>1000 x 10^9/L) unresponsive to therapy\r\n\r\n                    -  Increasing spleen size and increasing white blood cell (WBC) count\r\n                       unresponsive to therapy\r\n\r\n                    -  Cytogenetic evidence of clonal evolution (i.e., the appearance of an\r\n                       additional genetic abnormality that was not present in the initial specimen\r\n                       at the time of diagnosis of chronic phase CML)\r\n\r\n                    -  Resistance to tyrosine kinase inhibitors (imatinib or other) defined as no\r\n                       complete cytogenetic response even if the above criteria are not met.\r\n\r\n               -  Blast phase is defined by either of the following:\r\n\r\n                    -  Blasts 20% or more of peripheral blood white cells or bone marrow cells\r\n\r\n                    -  Extramedullary blast proliferation\r\n\r\n                    -  Large foci or clusters of blasts in bone marrow biopsy\r\n\r\n          -  Primary myelodysplastic syndrome (MDS) with an IPSS score >1\r\n\r\n          -  Secondary MDS with any international prostate symptom score (IPSS)\r\n\r\n          -  Age 60 years\r\n\r\n          -  Co-Morbidity score 0-2\r\n\r\n          -  At least 35 days following start of preceding leukemia induction therapy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients for whom a suitable HLA genotypically identical sibling or fully matched\r\n             HLA-A, -B, -C, and -DRB1 unrelated donor is available.\r\n\r\n          -  Patients greater than 60 years of age.\r\n\r\n          -  Hypersensitivity to thymoglobulin.\r\n\r\n          -  Symptomatic uncontrolled coronary artery disease or congestive heart failure.\r\n\r\n          -  Hepatic disease with transaminases or bilirubin > 2 times upper limit of normal (ULN)\r\n             except for isolated hyperbilirubinemia attributed to Gilbert's syndrome.\r\n\r\n          -  Severe hypoxemia with room air - Partial Pressure of Oxygen in Arterial Blood - (PAO2)\r\n             < 70, supplemental oxygen-dependence, or carbon monoxide diffusing capacity (DLCO) <\r\n             50% predicted.\r\n\r\n          -  Impaired renal function with creatinine > 2 times upper limit of normal (ULN) or\r\n             creatinine clearance measured by 24-hour urine collection < 50% normal for age,\r\n             gender, and weight.\r\n\r\n          -  Patients with central nervous system (CNS) involvement with disease refractory to\r\n             intrathecal chemotherapy.\r\n\r\n          -  Patients who are human immunodeficiency virus (HIV) seropositive.\r\n\r\n          -  Patients who are pregnant or breast-feeding.\r\n\r\n          -  Patients with active infections that are untreated, or failing to respond to\r\n             appropriate therapy.\r\n\r\n          -  Karnofsky performance status < 50%.\r\n\r\n          -  Prior allogeneic or autologous bone marrow, peripheral blood stem cell, or umbilical\r\n             cord blood transplant.\r\n\r\n          -  Inability to provide informed consent.\r\n\r\n          -  Co-morbidity score >2\r\n\r\n          -  Less than 35 days from start of previous leukemia induction therapy\r\n      ","sponsor":"Masonic Cancer Center, University of Minnesota","sponsor_type":"Other","conditions":"Leukemia|Myelodysplastic Syndromes","interventions":[{"intervention_type":"Biological","name":"Biological: anti-thymocyte globulin","description":"Rabbit thymoglobulin will be given intravenously at a dose of 2.5 mg/kg on days -5,-4, -3, and -2. The first dose of thymoglobulin will be given over six (6) hours and subsequent doses over four (4) or more hours as tolerated or, per institutional anti-thymocyte globulin (ATG) administration guidelines."},{"intervention_type":"Drug","name":"Drug: fludarabine phosphate","description":"Fludarabine 40 mg/m^2/day intravenously (IV) over 30-60 minutes on days -7,-6,-5,-4,-3 (total dose 200 mg/m^2)."},{"intervention_type":"Drug","name":"Drug: thiotepa","description":"Thiotepa 5 mg/kg/day intravenously (IV) over 4 hours on days -8, -7 (total dose 10 mg/kg)."},{"intervention_type":"Procedure","name":"Procedure: peripheral blood stem cell transplantation","description":"Peripheral Blood Stem Cell (PBSC) Infusion. All patients will receive granulocyte colony-stimulating factor (G-CSF)-mobilized PBSC on day 0 (or day+1 when available) following CD34 cell selection for ex vivo T cell removal. PBSC is infused via a central venous catheter using blood infusion tubing."},{"intervention_type":"Radiation","name":"Radiation: total-body irradiation","description":"The total-body irradiation (TBI) will be given in 2 fractions of 400 cGy each administered on day -10 and -9 via anterior and posterior fields for a total dose of 800 cGy."}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of Disease-free Survival","time_frame":"1 Year","description":"Number of patients alive and without disease at 1 year after transplant."},{"outcome_type":"secondary","measure":"Incidence of Disease Relapse","time_frame":"1 Year","description":"Number of patients with disease at 1 year."},{"outcome_type":"secondary","measure":"Incidence of Grade II-IV Acute Graft-vs-host Disease (GVHD)","time_frame":"Day 100","description":"Number of patients with grade II-IV acute graft-versus-host disease at Day 100 post transplant. Graft-versus-host disease (GVHD) is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as \"foreign\" and mount an immunologic attack. Grade I=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening."},{"outcome_type":"secondary","measure":"Incidence of Chronic Graft-versus-host Disease (GVHD)","time_frame":"1 Year","description":"Number of patients with chronic graft-versus-host disease at 1 year post transplant. Graft-versus-host disease (GVHD) is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as \"foreign\" and mount an immunologic attack. Grade I=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening. Chronic GVHD is an extension of acute GVHD."},{"outcome_type":"secondary","measure":"Incidence of Graft Failure","time_frame":"Day 100","description":"Number of patients with graft failure is defined by lack of neutrophil engraftment by 100 days after transplant in patients surviving a minimum of 14 days."},{"outcome_type":"secondary","measure":"Transplant-related Mortality","time_frame":"1 Year","description":"Number of patients with treatment related death at 1 year post transplant."},{"outcome_type":"secondary","measure":"Overall Survival","time_frame":"1 Year","description":"Number of patients who were deceased at 1 year post transplant."}]}
{"nct_id":"NCT00265304","start_date":"2005-07-31","phase":"Phase 2","enrollment":550,"brief_title":"A Long-Term Safety Study of IDEA-033 in Comparison to Oral Naproxen for the Treatment of Osteoarthritis of the Knee","official_title":"A Double-Blind, Long-Term Evaluation of the Safety of IDEA-033 in Comparison to Oral Naproxen for the Treatment of the Signs and Symptoms of Osteoarthritis of the Knee","primary_completion_date":"2007-07-31","study_type":"Interventional","rec_status":"Completed","last_update":"2009-03-20","description":"The purpose of this study is to evaluate the long-term safety of IDEA-033 (an anti-inflammatory pain-relieving drug applied to the skin) in comparison to naproxen (an anti-inflammatory pain-relieving drug taken by mouth) for the treatment of osteoarthritis of both knees.","other_id":"CL-033-III-05","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients who completed Study 17-007 or discontinued from Study 17-007 due to lack of\r\n             efficacy\r\n\r\n          -  Patients who did not complete or discontinue from Study 17-007 must have\r\n             osteoarthritis of both knees for a minimum of six months\r\n\r\n          -  Have moderate pain in the most involved knee when not taking non-steroidal\r\n             anti-inflammatory drugs (NSAIDs)\r\n\r\n          -  Must have used an oral NSAID on at least three days per week for the last three\r\n             months, or 25 of the 30 days before screening\r\n\r\n          -  Demonstrate x-ray evidence of osteoarthritis in the most involved knee during the last\r\n             six months\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any patient currently receiving physical therapy to either knee or having a history of\r\n             allergy, hypersensitivity or contraindication to ketoprofen, naproxen, or\r\n             acetaminophen, an NSAID idiosyncrasy, or any other medical condition that would\r\n             compromise the ability of the subject to complete the required assessments and visits\r\n\r\n          -  For patients who did not participate in Study 17-007: having Grade 1 or Grade 4\r\n             severity of the most involved knee based on x-ray criteria\r\n\r\n          -  Received intra-articular injections or arthroscopy of the most involved knee during\r\n             three months before screening visit\r\n\r\n          -  Have a large bulging effusion, or have inflammation of the most involved knee that\r\n             could be related to gout, pseudogout-induced synovitis, or infection\r\n\r\n          -  Have a history of partial or total knee replacement in either knee, or have a history\r\n             of gout, pseudo-gout induced synovitis, or infection of the more severe knee\r\n      ","sponsor":"IDEA AG","sponsor_type":"Industry","conditions":"Osteoarthritis, Knee","interventions":[{"intervention_type":"Drug","name":"Drug: Ketoprofen"}],"outcomes":[{"outcome_type":"primary","measure":"Adverse events; Dermal-irritation scores; Changes in routine clinical laboratory tests and vital signs obtained at each visit."},{"outcome_type":"secondary","measure":"Change from baseline (Week 12 for patients who completed 17-007, baseline for those who did not) and mean value per visit for WOMAC pain, stiffness, and physical function scores; Subject Global Assessment of Response to Therapy."}]}
{"nct_id":"NCT01687556","start_date":"2005-07-31","phase":"N/A","enrollment":35,"brief_title":"EGCG Improves Acne by Modulating Molecular Targets","official_title":"Epigallocatechin-3-Gallate Improves Acne in Humans by Modulating Intracellular Molecular Targets and Inhibiting P. Acnes","primary_completion_date":"2006-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2006-06-30","last_update":"2012-09-19","description":"Epigallocatechin-3-gallate (EGCG) may improve acne vulgaris - major polyphenolic constituent in green tea - known as potent anti-carcinogenic, anti-inflammatory, anti-proliferative, and antimicrobial activities - lipid-lowering and antiandrogenic properties was reported - EGCG can improve acne vulgaris via one of the above mentioned actions.","other_id":"04-2005-043-0","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":15,"maximum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  age of at least 15 years\r\n\r\n          -  clinical diagnosis of mild to moderate acne vulgaris\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  known pregnancy or lactation\r\n\r\n          -  any medical illness that might influence the results of the study,\r\n\r\n          -  a previous history of oral acne medication or surgical procedures including laser\r\n             treatment within 6 month and topical medication within 4 weeks of study enrollment.\r\n      ","sponsor":"Seoul National University Hospital","sponsor_type":"Other","conditions":"Acne Vulgaris","interventions":[{"intervention_type":"Other","name":"Other: topical EGCG application on acne","description":"two times application of topical EGCG on acne lesion"}],"outcomes":[{"outcome_type":"primary","measure":"Assessment of acne severity","time_frame":"8 week after baseline","description":"Lesion counts of non-inflammatory lesions (closed comedone, open comedone) and severity measured by Reeds revised scale"},{"outcome_type":"secondary","measure":"2-mm punch biopsy of acne lesion on the EGCG-treated sides","time_frame":"8 week after baseline"},{"outcome_type":"secondary","measure":"Standardized clinical photographs","time_frame":"8 week after baseline"}]}
{"nct_id":"NCT00210327","start_date":"2005-07-31","phase":"Phase 2","enrollment":33,"brief_title":"VELCADE in MALT Lymphoma Pretreated With Prior Systemic Therapy","official_title":"Phase II Study of VELCADE in Patients With Extranodal Marginal Zone B-cell Lymphoma of MALT-type Pretreated With Prior Systemic Therapy Regimen (X05142)","primary_completion_date":"2008-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-04-30","last_update":"2009-07-22","description":"The primary objective of this study is to assess the antitumor activity (in terms of overall response rate - ORR - i.e. sum of complete and partial responses)of bortezomib in pretreated MALT lymphomas with one prior sistemic therapy regimen","other_id":"IELSG25A","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. histologically proven d MALT lymphoma at any extranodal site\r\n\r\n          2. any stage (Ann Arbor I-IV)\r\n\r\n          3. relapsed or refractory disease pretreated with prior chemotherapy regimens +/-\r\n             anti-CD20 immunotherapy or prior anti-CD20 immunotherapy (any number of prior lines of\r\n             therapy)\r\n\r\n          4. no evidence of histologic transformation to a high grade lymphoma\r\n\r\n          5. measurable or evaluable disease\r\n\r\n          6. age > 18 years\r\n\r\n          7. full recovery from previous therapy, with life expectancy of at least 6 months\r\n\r\n          8. ECOG performance status 0-2\r\n\r\n          9. for primary gastric localized H. pylori-positive disease at diagnosis:\r\n\r\n               1. persistent disease 1 year after documented H. pylori infection eradication\r\n\r\n               2. clinical, endoscopic (or histologic) evidence of progression at any time after H.\r\n                  pylori infection eradication\r\n\r\n         10. no prior chemotherapy, immunotherapy or radiotherapy in the last 6 weeks\r\n\r\n         11. no corticosteroids during the last 4 weeks, unless prednisone chronically administered\r\n             at a dose <20 mg/day for indications other than lymphoma or lymphoma-related symptoms\r\n\r\n         12. adequate renal function (calculated or measured creatinine clearance >30 mL/minute),\r\n             liver function (ASAT/ALAT <2,5 upper normal, total bilirubin <2,5x upper normal) and\r\n             bone marrow function\r\n\r\n         13. no evidence of active opportunistic infections\r\n\r\n         14. no known HIV infection\r\n\r\n         15. no active HBV and/or HCV infection\r\n\r\n         16. no serious medical illness likely to interfere with participation in this clinical\r\n             study\r\n\r\n         17. voluntary written informed consent before performance of any study-related procedure\r\n\r\n         18. female subject is either post-menopausal or surgically sterilized or willing to use an\r\n             acceptable method of birth control (ie, a hormonal contraceptive, intra-uterine\r\n             device, diaphragm with spermicide, condom with spermicide, or abstinence) for the\r\n             duration of the study. Male subject agrees to use an acceptable method for\r\n             contraception for the duration of the study\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia\r\n             type 1(CIN1) or localized non-melanomatous skin cancer\r\n\r\n          2. other investigational drugs within 14 days before enrollment\r\n\r\n          3. evidence of symptomatic central nervous system (CNS) disease\r\n\r\n          4. severe impairment of bone marrow function (ANC <1.0x109/L, PLT <30x109/L within 14\r\n             days before enrollment), unless due to lymphoma involvement\r\n\r\n          5. evidence of  grade 2 peripheral neuropathy within 14 days before enrollment\r\n\r\n          6. known hypersensitivity to bortezomib, boron or mannitol\r\n\r\n          7. pregnant or lactating status, confirmation that the subject is not pregnant must be\r\n             established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy\r\n             test result obtained during screening. Pregnancy testing is not required for\r\n             post-menopausal or surgically sterilized women\r\n\r\n          8. any psychological, familial, sociological or geographical condition potentially\r\n             hampering compliance with the study protocol and follow-up schedule; those conditions\r\n             should be discussed with the patient before registration in the trial\r\n      ","sponsor":"International Extranodal Lymphoma Study Group (IELSG)","sponsor_type":"Other","conditions":"Lymphoma, Mucosa-Associated Lymphoid Tissue","interventions":[{"intervention_type":"Drug","name":"Drug: Bortezomib (drug)"}],"outcomes":[{"outcome_type":"primary","measure":"Antitumor activity, in terms of overall response rate (ORR) i.e. sum of complete and partial responses"},{"outcome_type":"secondary","measure":"Safety, as acute and long-term toxicity"},{"outcome_type":"secondary","measure":"Response duration (RD) (time to relapse or progression) in responders"},{"outcome_type":"secondary","measure":"Progression-free survival (PFS) (time to disease progression or death from lymphoma) in all patients"}]}
{"nct_id":"NCT00225017","start_date":"2005-06-30","phase":"Phase 3","enrollment":50,"brief_title":"Switch to Atazanavir and Brachial Artery Reactivity (SABAR) Study","official_title":"Switch to Atazanavir and Brachial Artery Reactivity (SABAR) Study: Endothelial Function in HIV-Infected Subjects Switched to an Atazanavir Regimen","primary_completion_date":"2008-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-06-30","last_update":"2012-08-02","description":"The purpose of this study is to evaluate the change in brachial artery reactivity in HIV-infected subjects with elevated lipid levels who are switched to an atazanavir containing antiretroviral regimen","other_id":"SABAR","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  HIV infection\r\n\r\n          -  HIV-1 RNA < 500 copies/ml\r\n\r\n          -  Fasting LDL cholesterol >130 mg/dl OR fasting triglycerides >200 mg/dl\r\n\r\n          -  CD4 count >100 cells/mm\r\n\r\n          -  Stable antiretroviral regimen for at least 12 weeks prior to study entry that includes\r\n             a protease inhibitor (PI) with or without ritonavir boosting\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of heart disease, uncontrolled hypertension, peripheral vascular disease\r\n\r\n          -  Current non-nucleoside reverse transcriptase inhibitor (NNRTI) in the PI-containing\r\n             regimen within 4 weeks\r\n\r\n          -  Prior or current use of atazanavir\r\n\r\n          -  Initiation of treatment with lipid-lowering drugs within 4 weeks prior to study entry\r\n      ","sponsor":"Northwestern University","sponsor_type":"Other","conditions":"HIV Infection|Hyperlipidemia","interventions":[{"intervention_type":"Drug","name":"Drug: Atazanavir","description":"atazanavir 400 mg once daily"},{"intervention_type":"Drug","name":"Drug: current antiretroviral regimen","description":"Continue current antiretroviral regimen for 24 weeks, single or RTV-boosted PI plus > 2 NRTIs"}],"outcomes":[{"outcome_type":"primary","measure":"Percentage Change in Brachial Artery Flow Mediated (FMD) Vasodilation Between Arms From Baseline to Week 24","time_frame":"Baseline to week 24","description":"Brachial artery reactivity assessed by noninvasively measuring brachial artery diameter and flow velocities in response to overinflated blood pressure cuff (Flow mediated dilation (FMD))in subjects switching to atazanavir and in subjects continuing on a stable antiretroviral regimen"},{"outcome_type":"secondary","measure":"Change in Total Cholesterol Levels From Baseline to Week 24","time_frame":"Baseline to 24 weeks","description":"Total cholesterol level changes within and between arms"},{"outcome_type":"secondary","measure":"Changes in LDL Particle Number From Baseline to Week 24","time_frame":"Baseline to 24 weeks","description":"Change in LDL particle number"}]}
{"nct_id":"NCT00106665","start_date":"2005-06-30","enrollment":170,"brief_title":"New Onset Weakness in Critically Ill Patients and the Risk of Death and Recurrent ICU Admission","official_title":"Intensive Care Unit(ICU)-Acquired Paresis and the Risk for Mortality and Recurrent ICU Admission (Weakness and ICU Readmission Evaluation-WIRE)","primary_completion_date":"2007-07-31","study_type":"Observational","rec_status":"Completed","completion_date":"2007-07-31","last_update":"2016-01-18","description":"This study seeks to define the morbidity of critical care polyneuropathy and to confirm that this diagnosis is, in fact, independently associated with increased mortality. Secondary information regarding the reasons for ICU readmission in patients with weakness may help in formulating cogent discharge strategies for these patients. Measurement of weakness using handgrip strength may provide a useful surrogate marker for weakness that may be more easily and uniformly applied. Primary hypothesis: - The development of ICU-associated weakness is independently associated with excess attributable mortality. Secondary hypothesis: - The development of ICU-associated weakness is associated with an increased need for ICU readmission. - Readmission to the ICU will be a result of the development of recurrent respiratory failure or insufficiency - Handgrip strength testing will detect ICU-associated weakness with an equivalent sensitivity as the comprehensive bedside muscle strength exam.","other_id":"2004H0255","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"Critically ill patients requireing mechanical ventilation","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adult (age > or = 18) patients admitted to the Medical ICU\r\n\r\n          -  Respiratory failure requiring mechanical ventilation > or = 5 days\r\n\r\n          -  Reasonable expectation for a subsequent return of mental status\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patient's family, physician, or both not in favor of aggressive treatment of patient\r\n             or presence of an advanced directive to withhold life-sustaining treatment\r\n\r\n          -  Pregnancy\r\n\r\n          -  Admitted to ICU from outside hospital\r\n\r\n          -  New or pre-existing diagnosis causing current neuromuscular weakness\r\n\r\n          -  Profound and uncorrectable hypokalemia or hypophosphatemia [K < 2.5 or P < 1.0\r\n             throughout enrollment window]\r\n\r\n          -  Inability to assess muscle strength in more than six muscle groups in at least two\r\n             extremities [Bilateral amputation (BKA or AKA), severe burns, skin lesions or\r\n             dressings limiting ability of examiner to access and forcibly resist movement of the\r\n             patients extremities]\r\n\r\n          -  Inability to communicate or follow commands of the examiner [persistent coma, severe\r\n             MRDD (mental retardation and developmental disabilities) or continuing necessary\r\n             medication use that impairs consciousness (i.e. narcotics), non-English speaker]\r\n\r\n          -  Concurrent enrollment in another clinical trial involving steroids > 20 mg/day\r\n             prednisone equivalent for > 3 days, neuromuscular blockade for > 24 hours or any\r\n             aminoglycosides.\r\n\r\n          -  Prisoner or other subject where legal surrogate decision maker is in question\r\n      ","sponsor":"Naeem Ali, MD","sponsor_type":"Other","conditions":"Muscle Weakness|Critical Illness","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Hospital mortality","time_frame":"during hospitalization"},{"outcome_type":"secondary","measure":"recurrent respiratory failure","time_frame":"hospitalization"}]}
{"nct_id":"NCT00246233","start_date":"2005-06-30","phase":"Phase 3","enrollment":145,"brief_title":"CONCERTA (Methylphenidate Hydrochloride) as add-on Therapy in the Treatment of Adult Major Depressive Disorder.","official_title":"A Double-blind, Placebo-controlled, Randomized Trial to Evaluate the Safety, Tolerability and Efficacy of CONCERTA (Methylphenidate Hydrochloride) Augmentation of SSRI/SNRI Monotherapy in Adult Patients With Major Depressive Disorder.","study_type":"Interventional","rec_status":"Completed","completion_date":"2006-04-30","last_update":"2011-05-17","description":"The purpose of this study is to evaluate the effects of the addition of CONCERTA (methylphenidate hydrochloride, a central nervous system (CNS) stimulant) or placebo in adult outpatients with Major Depressive Disorder who are currently being treated with oral antidepressant medication (selective serotonin reuptake inhibitors or selective norepinephine reuptake inhibitors). The general symptoms of depression will be evaluated, as measured by the Montgomery Asberg Depression Rating Score (MADRS) on fatigue, energy, and overall severity of illness. The safety and tolerability of the CONCERTA and antidepressant combination therapy will also be assessed.","other_id":"CR006073","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Currently having a Major Depressive Disorder episode without psychotic features\r\n\r\n          -  Has had an inadequate response to at least one but not more than 3 antidepressants\r\n             given for 4 weeks\r\n\r\n          -  Is currently treated with an antidepressant for the past 4 weeks\r\n\r\n          -  Has a Montgomery Asberg Depression Rating Scale (MADRS) total score greater than or\r\n             equal to 20, lassitude score of greater than or equal to 2 and a suicidal thought\r\n             score less than 4\r\n\r\n          -  Has a Clinical Global Impression of Severity (CGI-S) score greater than or equal to 4\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Has a current diagnosis of schizophrenia, bipolar disorder, dementia, psychosis,\r\n             obsessive-compulsive disorder, post-traumatic stress disorder, panic disorder,\r\n             Attention Deficit Hyperactivity Disorder (ADHD), anorexia nervosa and/or bulimia\r\n             nervosa, or a history of ADHD, anorexia nervosa and/or bulimia nervosa\r\n\r\n          -  Agitated during the current depressive episode\r\n\r\n          -  Has significant abnormal personality traits, which could interfere with function\r\n\r\n          -  Has a history of substance abuse and or dependence within 6 months prior to screening\r\n      ","sponsor":"Janssen-Ortho Inc., Canada","sponsor_type":"Industry","conditions":"Depressive Disorder, Major","interventions":[{"intervention_type":"Drug","name":"Drug: methylphenidate"}],"outcomes":[{"outcome_type":"primary","measure":"Change in total Montgomery Asberg Depression Rating Scale (MADRS) score between the two groups from baseline to the final visit."},{"outcome_type":"secondary","measure":"Safety and tolerability of study drug based on adverse events and clinical laboratory tests, ECG, vital signs and physical examination, finding changes from baseline to the final visit."}]}
{"nct_id":"NCT00249080","start_date":"2005-06-30","enrollment":182,"brief_title":"Magnetic Resonance Imaging (MRI) of Brain Iron in Neurodegenerative Disease","official_title":"High Field MRI of Brain Iron in Neurodegenerative Disease","study_type":"Observational","rec_status":"Completed","completion_date":"2007-08-31","last_update":"2009-08-24","description":"Neurodegenerative diseases, such as Alzheimer's disease, Parkinson's disease, and multiple sclerosis are recognized as a major health concern at the present time. There is information in magnetic resonance imaging (MRI) studies regarding the role of brain iron in normal brain aging that may be enhanced with the use of better scanning equipment and procedures, and by correlating this information with clinical data. This research study aims to develop and evaluate a number of techniques that can potentially improve the effectiveness of three tesla (3T) magnetic resonance imaging of neurodegenerative brain disorders.","other_id":"AMC-IRB-1599","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Approximately equal numbers of subjects with clinically diagnosed Alzheimer's disease,\r\n        multiple sclerosis, Parkinson's disease and normal controls (age and gender matched).","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18 years or older\r\n\r\n          -  Healthy person without memory complaints OR person diagnosed with a neurodegenerative\r\n             disease (ie, Alzheimer's disease, Parkinson's disease, multiple sclerosis)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  MR contraindication such as metal in body (ie, pacemaker, implant, shrapnel, etc.)\r\n\r\n          -  Pregnant\r\n\r\n          -  Claustrophobic anxieties\r\n      ","sponsor":"Albany Medical College","sponsor_type":"Other","conditions":"Neurodegenerative Diseases|Mild Cognitive Impairment","interventions":{},"outcomes":{}}
{"nct_id":"NCT00460291","start_date":"2005-06-30","phase":"N/A","enrollment":50,"brief_title":"Pilot Study to Asses the Function and Patency of Polyester-Coated Composite Bypasses From Autologous Varicose Veins","official_title":"Pilot Study to Asses the Function and Patency of Polyester-Coated Composite Bypasses From Autologous Varicose Veins","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2008-12-31","last_update":"2007-10-03","description":"If patients need to undergo bypass surgery, either an autologous vein can be used as bypass or, if there are no suitable veins are available, a prosthetic graft can be implanted. Varicose veins normally are judged not to be suitable as bypass. The ProVena vein support, made from polyester, is considered to strengthen varicose veins so that they they become suitable as bypass. Thereby, the advantages of an autologous bypass and the stability of polyester material can be combined. Patients that take part in the trial recieve an autologus bypass with a varicose vein, coated with ProVena. They are followed up at 3 and 6 months after implantation of a ProVena-coated bypass via duplex-sonography to assess the graft patency.","other_id":"ProVena","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  aged > 18 years 18 Jahre.\r\n\r\n          -  informed consent has been given and patients is complient to protocol\r\n\r\n          -  patient needs femoro-distal bypass surgery\r\n\r\n          -  only varicose ektatic veins are available\r\n\r\n          -  Bypass diameter > 5mm proximal and > 4mm distal.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  aged < 18 years\r\n\r\n          -  patient unable to take part in the follow-up\r\n\r\n          -  known sensibility to polyester\r\n\r\n          -  patient not expected to survive the next 12 months due to significant comorbidities\r\n\r\n          -  HIV-infection\r\n\r\n          -  Patient suffering from a floriding infection at the time of inclusion\r\n\r\n          -  infection or colonisation with MRSA\r\n\r\n          -  pregnancy\r\n\r\n          -  use of immunosuppresive drugs\r\n      ","sponsor":"Johann Wolfgang Goethe University Hospital","sponsor_type":"Other","conditions":"Peripheral Arterial Disease|Peripheral Bypass Surgery|Bypass From Autologous Varicose Vein|External Graft Support","interventions":[{"intervention_type":"Device","name":"Device: Implantation of the ProVena vein graft during bypass surgery"}],"outcomes":[{"outcome_type":"primary","measure":"infection rate"},{"outcome_type":"primary","measure":"primary patency"},{"outcome_type":"primary","measure":"primary assisted patency"},{"outcome_type":"primary","measure":"secondary patency"},{"outcome_type":"secondary","measure":"occurrence of complications"},{"outcome_type":"secondary","measure":"occurence of stenoses"},{"outcome_type":"secondary","measure":"time needed for preparation of the bypass vein"},{"outcome_type":"secondary","measure":"technical success"}]}
{"nct_id":"NCT00134069","start_date":"2005-06-30","phase":"Phase 1","enrollment":48,"brief_title":"Sorafenib, Cetuximab, and Irinotecan in Treating Patients With Advanced or Metastatic Colorectal Cancer","official_title":"Phase I/II Clinical, Pharmacological, and Biological Study of BAY 43-9006 in Combination With Cetuximab and Irinotecan in Patients With Advanced Colorectal Cancer","primary_completion_date":"2010-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-12-31","last_update":"2014-04-16","description":"This phase I/II trial is studying the side effects and best dose of sorafenib when given together with cetuximab and irinotecan and to see how well they work in treating patients with advanced or metastatic colorectal cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Sorafenib and cetuximab may also stop tumor growth by blocking blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan, work in different ways to kill tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with cetuximab and irinotecan may kill more tumor cells","other_id":"NCI-2009-00110","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically or cytologically confirmed colorectal cancer (advanced or metastatic\r\n             disease not amenable to potential curative resection)\r\n\r\n          -  Archival tumor (blocks and/or slides) must be available for patients who decline tumor\r\n             biopsies\r\n\r\n          -  Tumor must be amenable to sequential biopsies for patients willing to undergo tumor\r\n             biopsy\r\n\r\n          -  Must have evidence of disease progression after first-line chemotherapy for advanced\r\n             disease\r\n\r\n          -  Previously irradiated lesions are not considered measurable disease\r\n\r\n          -  Measurable disease, defined as >= 1 unidimensionally measurable target lesion >= 20 mm\r\n             by conventional techniques OR >= 10 mm by spiral CT scan\r\n\r\n          -  No known brain metastases\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) 0-2 OR Karnofsky 60-100%\r\n\r\n          -  Life expectancy of more than 12 weeks\r\n\r\n          -  white blood cell count (WBC) >= 3,000/mm^3\r\n\r\n          -  Bilirubin normal\r\n\r\n          -  Creatinine normal OR creatinine clearance >= 60 mL/min\r\n\r\n          -  No hypertension\r\n\r\n          -  No symptomatic congestive heart failure\r\n\r\n          -  No unstable angina pectoris\r\n\r\n          -  No cardiac arrhythmia\r\n\r\n          -  Not pregnant or nursing\r\n\r\n          -  Able to swallow oral medication\r\n\r\n          -  Willing to undergo 2 sequential tumor and skin biopsies\r\n\r\n          -  No ongoing or active infection\r\n\r\n          -  No history of allergic reaction attributed to compounds of similar chemical or\r\n             biologic composition to study drugs\r\n\r\n          -  No psychiatric illness or social situation that would preclude study compliance\r\n\r\n          -  No other uncontrolled illness\r\n\r\n          -  No prior cetuximab\r\n\r\n          -  No concurrent prophylactic filgrastim (G-CSF), sargramostim (GM-CSF) or epoetin alfa\r\n\r\n          -  At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and\r\n             recovered\r\n\r\n          -  No other concurrent chemotherapy\r\n\r\n          -  More than 4 weeks since prior radiotherapy and recovered\r\n\r\n          -  No prior sorafenib\r\n\r\n          -  No other prior therapy targeted against MAPK\r\n\r\n          -  More than 14 days since prior and no concurrent administration of the following\r\n             cytochrome P450 3A4 (CYP3A4) inducers:\r\n\r\n               -  Rifampin\r\n\r\n               -  Rifabutin\r\n\r\n               -  Hypericum perforatum (St. John's wort)\r\n\r\n               -  Phenytoin\r\n\r\n               -  Carbamazepine\r\n\r\n               -  Phenobarbital\r\n\r\n          -  More than 7 days since prior and no concurrent administration of the following CYP3A4\r\n             inhibitors:\r\n\r\n               -  Amiodarone\r\n\r\n               -  Clarithromycin\r\n\r\n               -  Diltiazem\r\n\r\n               -  Erythromycin\r\n\r\n               -  Grapefruit juice\r\n\r\n               -  Indinavir\r\n\r\n               -  Saquinavir\r\n\r\n               -  Lopinavir in combination with ritonavir\r\n\r\n               -  Fosamprenavir\r\n\r\n               -  Ritonavir\r\n\r\n               -  Atazanavir\r\n\r\n               -  Nelfinavir\r\n\r\n               -  Itraconazole\r\n\r\n               -  Ketoconazole\r\n\r\n               -  Nefazodone\r\n\r\n          -  No concurrent combination antiretroviral therapy for HIV-positive patients\r\n\r\n          -  No other concurrent investigational agents\r\n\r\n          -  No other concurrent anticancer therapy\r\n\r\n          -  Negative pregnancy test\r\n\r\n          -  Fertile patients must use effective contraception\r\n\r\n          -  Absolute neutrophil count >=1,500/mm^3\r\n\r\n          -  Platelet count  100,000/mm^3\r\n\r\n          -  No evidence of bleeding diathesis\r\n\r\n          -  Aspartate aminotransferase (AST) and Alanine Aminotransferase (ALT)  2.5 times upper\r\n             limit of normal\r\n      ","sponsor":"National Cancer Institute (NCI)","sponsor_type":"NIH","conditions":"Recurrent Colon Cancer|Recurrent Rectal Cancer|Stage III Colon Cancer|Stage III Rectal Cancer|Stage IV Colon Cancer|Stage IV Rectal Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: sorafenib tosylate","description":"Given orally"},{"intervention_type":"Drug","name":"Drug: cetuximab","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: irinotecan hydrochloride","description":"Given IV"}],"outcomes":[{"outcome_type":"primary","measure":"Toxicity spectrum and dose-limiting toxicities of sorafenib in combination with cetuximab and irinotecan as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v 3.0","time_frame":"Up to 30 days"},{"outcome_type":"primary","measure":"Recommended dose for phase II evaluation of the combination of sorafenib, cetuximab and irinotecan","time_frame":"56 days"},{"outcome_type":"primary","measure":"Clinical activity of the combination of sorafenib, cetuximab and irinotecan in terms of radiological response","time_frame":"Up to 30 days"},{"outcome_type":"primary","measure":"Pharmacokinetics of sorafenib, cetuximab, and irinotecan when given in combination or when given in combination with cetuximab alone and with cetuximab and irinotecan","time_frame":"Up to 30 days"},{"outcome_type":"primary","measure":"Pharmacodynamics of the combination of irinotecan when given in combination with sorafenib and cetuximab in tumor tissues","time_frame":"Up to 30 days"}]}
{"nct_id":"NCT00570856","start_date":"2005-06-30","phase":"Phase 4","enrollment":60,"brief_title":"Trial of Folic Acid Effect on Hcy and cIMT After Kidney Tx","official_title":"Clinical Trial of Effectiveness of Folic Acid Therapy on Homocysteine Level and Carotid Intima-Media Thickness After Kidney Transplantation","study_type":"Interventional","rec_status":"Terminated","completion_date":"2006-03-31","last_update":"2007-12-19","description":"To see the effect of Folic acid supplementation after kidney transplantation on plasma total homocysteine level and carotid intimal-media thickness","other_id":"110","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Diagnostic","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":25,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  having hyperhomocysteinemia(tHcy>12.5 mol/L in men and 11.5 mol/L in women )\r\n\r\n          -  No evident history of CVD 4. no evidence of cigarette smoking\r\n\r\n          -  not participating in other clinical studies on evaluation of cardiac diseases and\r\n\r\n          -  not taking any lipid lowering treatment\r\n\r\n          -  not being pregnant or breast feeding a baby(women)\r\n\r\n          -  Having HIV or viral hepatitis infections.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  unstable condition of the transplanted kidney (Cr> 3 mg/dl, BUN > 50 mg/dl)\r\n\r\n          -  Cyclosporine (CsA) intoxication\r\n\r\n          -  New onset of any severe disease ( such as MI, stroke, DM, etc.).\r\n      ","sponsor":"Shahid Beheshti University of Medical Sciences","sponsor_type":"Other","conditions":"Kidney Transplantation","interventions":[{"intervention_type":"Drug","name":"Drug: Folic acid","description":"Folic acid 5 mg/day"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo similar to the folic acid tablets, 1/day"}],"outcomes":[{"outcome_type":"primary","measure":"plasma level of total homocysteine (tHcy)","time_frame":"6 months"},{"outcome_type":"secondary","measure":"carotid intima-media thickness (cIMT)","time_frame":"6 months"}]}
{"nct_id":"NCT00114335","start_date":"2005-05-31","enrollment":352,"brief_title":"Epidemiologic Data of Patients in a Teaching Hospital","official_title":"Prevalence of Impaired Renal Function in Medical Inpatients","study_type":"Observational","rec_status":"Completed","completion_date":"2005-07-31","last_update":"2008-10-10","description":"This small cross-sectional epidemiological study is designed to evaluate the prevalence of the following parameters in hospitalized patients in a tertiary teaching hospital (medical department only): - kidney insufficiency - obesity - use of unfractionated heparins / low molecular weight heparins - other drugs effecting the hemostatic system","other_id":"LMWHplus_1","observational_model":"Cohort","time_perspective":"Cross-Sectional","sampling_method":"Probability Sample","gender":"All","population":"All patients hospitalized at the defined days (two days) at Kantonsspital Luzern,\r\n        Department of Medicine","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  All patients hospitalized at the defined days (two days) at Kantonsspital Luzern,\r\n             Department of Medicine\r\n      ","sponsor":"Luzerner Kantonsspital","sponsor_type":"Other","conditions":"Kidney Diseases|Obesity","interventions":{},"outcomes":{}}
{"nct_id":"NCT00250653","start_date":"2005-05-31","phase":"Phase 3","enrollment":365,"brief_title":"A Fifty-two-week Study to Evaluate the Safety of Saredutant in Adult and Elderly Patients With Depression","official_title":"A Fifty-two-week, Multicenter, Open-label Study Evaluating the Long-term Safety and Tolerability of Saredutant in Adult and Elderly Patients With Major Depressive Disorder","primary_completion_date":"2007-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-04-30","last_update":"2012-02-17","description":"The purpose of the study is to evaluate the long-term safety of saredutant (or SR48968C) in adult and elderly patients with depression.The primary objective is to evaluate the long-term safety and tolerability of a 100 mg dose of saredutant in adult and elderly patients with depression. The secondary objective is to evaluate blood levels of saredutant.","other_id":"LTS5577","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female patients.\r\n\r\n          -  At least 18 years of age.\r\n\r\n          -  Inpatients or outpatients.\r\n\r\n          -  Written informed consent from the patient and/or legally authorized representative.\r\n\r\n          -  Able to comply with the protocol and follow written and verbal instructions.\r\n\r\n          -  Subjects of childbearing potential must have a confirmed negative serum b-hCG test\r\n             prior to entry into Segment B and must employ an acceptable method of birth control\r\n             (e.g., oral, depot, or implanted contraceptive method, IUDs, sterilization, barrier\r\n             methods in conjunction with spermicide).\r\n\r\n          -  Diagnosis of major depressive disorder, as defined by Diagnostic and Statistical\r\n             Manual of Mental Disorders, 4th edition, Text Revision criteria and confirmed by the\r\n             semi-structured Mini International Neuropsychiatric Interview (MINI), recurrent\r\n             episode for at least one month prior to the entry.\r\n\r\n          -  Minimum total score of 18 on the Hamilton Depression Rating Scale (HAM-D).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients whose current depressive episode is diagnosed with psychotic features,\r\n             catatonic features, seasonal pattern or post-partum onset.\r\n\r\n          -  The duration of the current depressive episode is greater than 2 years.\r\n\r\n          -  Patients who are currently suicidal or have a history of a suicide attempt within 3\r\n             years prior to entry.\r\n\r\n          -  Patients whose current depressive episode is secondary to a general medical disorder.\r\n\r\n          -  Patients with a history or presence of bipolar disorders or psychotic disorders\r\n             according to the D and L criteria of the MINI.\r\n\r\n          -  Patients with alcohol dependence or abuse or substance dependence or abuse in the past\r\n             12 months except nicotine or caffeine dependence.\r\n\r\n          -  Patients with a history of failure to respond to treatment with paroxetine or other\r\n             antidepressant medications.\r\n\r\n          -  Patients who have used the following prior to entry into Segment B: fluoxetine within\r\n             28 days, any monoamine oxidase inhibitor within 21 days, any other antidepressant,\r\n             anxiolytic, sedative-hypnotic, or mood-stabilizer (lithium, anticonvulsants) within 7\r\n             days except permitted concomitant medications.\r\n\r\n          -  Females who are pregnant or breast-feeding.\r\n\r\n          -  Severe or unstable cardiovascular, renal, hepatic, respiratory, hematological,\r\n             endocrinological, neurological, or other somatic disease that might interfere with the\r\n             evaluation of study medication.\r\n\r\n          -  History of seizures other than a single childhood febrile seizure.\r\n\r\n          -  ECG abnormalities of potential clinical significance including a QT interval with\r\n             Bazett's correction of 500 msec or more at entry.\r\n\r\n          -  Use of known inducers or potent inhibitors of CYP3A4 within 7 days of entry.\r\n\r\n          -  Use of drugs with known risk for Torsade de Pointes within 7 days of entry into\r\n             Segment B.\r\n\r\n          -  Participation in a clinical trial of an experimental therapy within 30 days prior to\r\n             entry or prior participation in a clinical trial of saredutant.\r\n\r\n          -  Patients with a positive HbsAg or anti-HCV antibody test at screening.\r\n\r\n          -  Patients with any of the following at screening: ALT >2 times the upper limit of the\r\n             normal range (XULN), AST >2XULN, GGT >3XULN, total or conjugated bilirubin >ULN\r\n\r\n          -  Elderly patients with a Mini-Mental State Examination total of score of <25.\r\n      ","sponsor":"Sanofi","sponsor_type":"Industry","conditions":"Depressive Disorder","interventions":[{"intervention_type":"Drug","name":"Drug: Saredutant succinate (SR48968C)"}],"outcomes":[{"outcome_type":"primary","measure":"The primary outcome is the proportion of patients experiencing at least one treatment-emergent adverse event."},{"outcome_type":"secondary","measure":"The main secondary outcomes are incidences of potentially clinically significant abnormalities and the changes from baseline in the values for clinical laboratories, vital signs, and electrocardiogram parameters."}]}
{"nct_id":"NCT00509782","start_date":"2005-05-31","phase":"Phase 1","enrollment":47,"brief_title":"Phase I Trial of ZIO-101 in Patients With Solid Tumors","official_title":"Phase I Trial of ZIO-101 in Patients With Solid Tumors","primary_completion_date":"2008-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-04-30","last_update":"2012-08-01","description":"Primary Objectives: 1. To determine the toxicities and maximum tolerated dose (MTD) of ZIO-101 when administered intravenously once a day for 5 consecutive days every 4 weeks in subjects with advanced solid tumors. 2. To determine the pharmacokinetic profile of ZIO-101 when administered intravenously once a day for 5 consecutive days every 4 weeks. Secondary Objective: 1. To determine the anti-tumor effects of ZIO-101.","other_id":"2004-0909","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patients with histological confirmation solid malignancy refractory to conventional\r\n             standard therapies for their condition.\r\n\r\n          2. Eligible subjects MUST have at least one measurable lesion as defined by RECIST\r\n             guidelines. If the measurable disease is restricted to a solitary lesion, its\r\n             neoplastic nature should be confirmed by cytology/histology. Measurable lesions MUST\r\n             not have been in a previously irradiated field or injected with biological agents.\r\n\r\n          3. Pediatric patients will be eligible at the discretion of the primary investigator.\r\n\r\n          4. ECOG performance status score <\/= 2.\r\n\r\n          5. Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically\r\n             sterile) must use acceptable contraceptive methods (abstinence, intrauterine device\r\n             [IUD], oral contraceptive or double barrier device), and must have a negative blood or\r\n             urine pregnancy test within 1 week before beginning treatment. Sexually active men\r\n             must also use acceptable contraceptive methods.\r\n\r\n          6. Patients must provide written informed consent prior to treatment.\r\n\r\n          7. At least four weeks from completion of prior therapy to day 1 of study drug.\r\n\r\n          8. Baseline toxicity assessment less than or equal to grade 1 except treatment induced\r\n             alopecia (NCI Common Terminology Criteria for Adverse Events [CTCAE] version 3.0).\r\n\r\n          9. Evidence of adequate multi-organ functional status as reflected by the following\r\n             clinical laboratory values: - Serum creatinine <\/= 2 times the upper normal limit OR a\r\n             calculated creatinine clearance <\/= 50 cc/min. - Total bilirubin <\/= 2 times the upper\r\n             normal limit. - Alanine aminotransferase (ALT), OR aspartate aminotransferase (AST)\r\n             <\/= 3 times the upper limit of normal.\r\n\r\n         10. Granulocytes in peripheral blood greater than or equal to 1 x 10(9) per liter,\r\n             hemoglobin greater than or equal to 8.5 g/dL, and platelets greater than or equal to\r\n             50,000 cells/microL.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Uncontrolled systemic infection (documented with microbiological studies).\r\n\r\n          2. Active heart disease as defined by an acute myocardial infarction within the previous\r\n             6 months before starting therapy, stable or unstable angina, clinically significant\r\n             arrhythmia requiring medical management, OR New York Heart Association Classification\r\n             of Functional Activities. Class 3: Patient has marked limitation in activities due to\r\n             symptoms, even during less-than-ordinary activity and is comfortable only at rest OR\r\n             Class 4: Severe limitations. Patient experiences symptoms even while at rest.\r\n\r\n          3. Concomitant therapy for solid cancer.\r\n\r\n          4. Pregnant subjects and those who are breast-feeding.\r\n\r\n          5. History of an invasive second primary malignancy diagnosed within the previous 3 years\r\n             except for Stage I Endometrial/Cervical Carcinoma or Prostate Carcinoma treated\r\n             surgically, and non-melanoma skin cancer.\r\n\r\n          6. Documented personal or family history of prolonged QT syndrome.\r\n\r\n          7. 12 lead electrocardiogram with a corrected QT interval >/= 460 milliseconds.\r\n\r\n          8. History of confusion or dementia.\r\n\r\n          9. History of seizure disorder.\r\n      ","sponsor":"M.D. Anderson Cancer Center","sponsor_type":"Other","conditions":"Solid Tumors","interventions":[{"intervention_type":"Drug","name":"Drug: ZIO-101","description":"Starting Dose 78 mg/m^2 intravenously daily for 5 consecutive days repeated every 4 weeks."}],"outcomes":[{"outcome_type":"primary","measure":"Maximum tolerated dose (MTD)","time_frame":"Daily for 5 consecutive days repeated every 4 weeks for 1 cycle; evaluation of 4-6 dose escalations to determine an MTD"}]}
{"nct_id":"NCT00412321","start_date":"2005-05-31","phase":"Phase 1","enrollment":67,"brief_title":"A Safety and Efficacy Study of CNTO 328 in Patients With B-Cell Non-Hodgkin's Lymphoma, Multiple Myeloma, or Castleman's Disease","official_title":"A Phase 1 Study of Multiple Intravenous Administrations of a Chimeric Antibody Against Interleukin-6 (CNTO 328) in Subjects With B-Cell Non-Hodgkin's Lymphoma, Multiple Myeloma, or Castleman's Disease","primary_completion_date":"2011-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-04-30","last_update":"2014-07-01","description":"The purpose of this study is to evaluate of the study of different CNTO 328 doses and schedules and to see if CNTO 328 has any effect on Non-hodgkin's Lymphoma, Multiple Myeloma or Castleman's disease.","other_id":"CR008566","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosed with B-cell non-Hodgkin's lymphoma, multiple myeloma, or Castleman's Disease\r\n             which has progressed on or after standard therapy or for which there is no effective\r\n             standard therapy, or which is not suitable for standard therapy\r\n\r\n          -  Detectable serum C-Reactive Protein\r\n\r\n          -  At least 4 weeks since prior systemic therapy, radiotherapy, or surgery\r\n\r\n          -  Must meet protocol lab criteria (adequate bone marrow, liver and renal function) to be\r\n             assessed at patient's first visit to the study center\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Received any investigational drug within 30 days or 5 half-lives of the\r\n             investigational drug, whichever is longer\r\n\r\n          -  History of receiving murine or human-murine recombination products, such as G250,\r\n             BE-8, and other monoclonal antibodies. (Note: Prior rituximab treatment is not an\r\n             exclusion criterion)\r\n\r\n          -  Serious concurrent illness or significant cardiac disease characterized by significant\r\n             ischemic coronary disease or congestive heart failure\r\n\r\n          -  Known human immunodeficiency virus seropositivity, acquired immunodeficiency syndome,\r\n             hepatitis C or active hepatitis B infection. For Cohort 7, known human herpesvirus-8\r\n             seropositivity\r\n\r\n          -  Presence of a transplanted solid organ (with the exception of a corneal transplant\r\n             more than 3 months prior to screening) or having received an allogeneic bone marrow\r\n             transplant or an allogeneic peripheral blood stem cell transplant\r\n      ","sponsor":"Centocor, Inc.","sponsor_type":"Industry","conditions":"Lymphoma, Non-Hodgkin|Multiple Myeloma|Giant Lymph Node Hyperplasia","interventions":[{"intervention_type":"Drug","name":"Drug: CNTO 328","description":"Patients will receive administrations of CNTO 328 with dose ranging from 3 mg/kg to 12 mg/kg weekly, every 2 or 3 weeks till Day 43 in cohorts 1 to 6. After cohort 6, if the clinical response is found to be suboptimal, the patients will receive 9 mg/kg or 12 mg/kg every 3 weeks in cohorts 7a. Participants in Cohort 7a who will experience intolerable toxicity after escalating to or receiving 12 mg/kg every 3 weeks will have the option of reverting to a dose of 9 mg/kg every 3 weeks if the investigator felt it was clinically indicated. In cohort 7b participants will receive 12 mg/kg CNTO 328 every 3 weeks."}],"outcomes":[{"outcome_type":"primary","measure":"Number of Patients With Adverse Events as a Measure of Safety and Tolerability","time_frame":"Up to 3 years after the last administration of study medication","description":"Number of Patients with adverse events will be reported."},{"outcome_type":"primary","measure":"Serum Concentration of CNTO 328","time_frame":"Up to Day 71","description":"Serum Concentration of CNTO 328 will be reported."},{"outcome_type":"secondary","measure":"Pharmacodynamics of CNTO 328","time_frame":"Up to Day 71","description":"Pharmacodynamic parameters C-reactive protein, interleukin-6 (IL-6), soluble IL-6 receptor [GP80], soluble GP130, TNFα, ΙL-8, IL-10, soluble IL-2 receptor (sIL-2R), IFNγ, serum amyloid A (SAA), N-telopeptide (NTx), C-telopeptide (CTx), hepcidin-25, VEGF, and fibroblast growth factor will be assessed."},{"outcome_type":"secondary","measure":"Plasma antibodies to CNTO 328","time_frame":"Up to Week 24","description":"Plasma antibodies to CNTO 328 will be used to evaluate the immunogenicity of CNTO 328."},{"outcome_type":"secondary","measure":"Number of participants with Castleman's disease who achieved tumor response","time_frame":"Screening phase (4 weeks before administration of study medication), Day 36, and Day 57","description":"Evaluation of tumor response for subjects with Castleman's disease were performed by central review according to the standard criteria, developed by an NCI-sponsored international working group (Cheson et al, 1999)."},{"outcome_type":"secondary","measure":"Number of participants with multiple myeloma who achieved disease response","time_frame":"Screening phase (4 weeks before administration of study medication), Day 36, and Day 57","description":"Evaluation of disease response for subjects with Multiple Myeloma were performed by the investigators according to the response criteria developed by an international group of multiple myeloma and bone marrow transplant experts (Blade et al, 1998)."},{"outcome_type":"secondary","measure":"Number of participants with B-cell non-Hodgkin's lymphoma and multiple myeloma who achieved clinical benefit (CB)","time_frame":"Up to Day 71","description":"CB will assess pain (by Pain intensity [PI] and 7-items assessing how much pain interfered with daily activities), performance status (by Karnofsky performance status which quantifies participant's well-being and activities of daily life), and weight change. PI score will be assessed by 4 questions (Q) rated on 11-point numerical rating scale ranging from \"0=no pain\" to \"10=higher severity of pain\". Each participant will be classified as either CB responder (i.e., if +ve for at least 1 of 3 primary CB measures and stable for other 2) or Non-responder (If a participant is stable on all 3 primary measures OR if -ve for any 1 of 3 primary measures)."},{"outcome_type":"secondary","measure":"Number of participants with Castleman's disease who achieved clinical benefit","time_frame":"Up to Day 71","description":"CB assessments for participant with Castleman's disease consist of the following 6 measures: hemoglobin, fatigue, anorexia, fever, weight, and size of largest lymph node. Each participant will be classified as either improved, stable, or worsening for each of the measures. If a participant has improved for at least 1 of the 6 measures and is at least stable for the remaining measures, participant will be considered to be a responder for CB. If a participant has worsening for at least 1 of the 6 measures, participant will be considered as having progression for CB. Any other participant will be considered to be stable for CB. Any \"improved\" or \"stable\" assessment of the lymph node parameter for CB must be confirmed by radiographic imaging. If a participant shows progression for CB at 2 consecutive assessments the participant must discontinue study treatment."},{"outcome_type":"secondary","measure":"Number of participants with B-cell non-Hodgkin's lymphoma who achieved disease response","time_frame":"Screening phase (4 weeks before administration of study medication), Day 36, and Day 57","description":"Evaluation of disease response for subjects with B-cell non-Hodgkin's lymphoma were performed by the investigators according to the standard criteria, developed by an NCI-sponsored international working group (Cheson et al, 1999)."}]}
{"nct_id":"NCT00076232","start_date":"2005-04-30","phase":"Phase 3","enrollment":3682,"brief_title":"A Study of Acyclovir to Help Prevent HIV Infection in People With Genital Herpes","official_title":"A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Acyclovir for the Reduction of HIV Acquisition Among High-Risk HSV-2 Seropositive, HIV Seronegative Individuals","primary_completion_date":"2007-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-11-30","last_update":"2010-12-30","description":"Genital herpes (HSV-2) is the most common cause of genital sores worldwide, and the presence of genital sores is a significant risk factor for becoming infected with HIV. This study will test the effectiveness of twice-daily dosing of acyclovir, a commonly prescribed anti-herpes drug, in preventing HIV infection in HSV-2 infected women who sleep with men (WSM) and men who sleep with men (MSM). Study hypothesis: Given that genital herpes is a significant risk factor to HIV acquisition, twice-daily HSV-2 suppressive therapy - 400 mg of acyclovir - will prevent HIV infection among high risk, HSV-2 seropositive WSM and MSM.","other_id":"HPTN 039","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria For All Participants:\r\n\r\n          -  HIV-uninfected\r\n\r\n          -  HSV-2 infected\r\n\r\n          -  Plans to stay in the area for the duration of study participation\r\n\r\n          -  Willing and able to provide consent, undergo clinical evaluations, take study drugs,\r\n             adhere to follow-up schedule, and provide adequate locator information\r\n\r\n        Inclusion Criteria for MSM:\r\n\r\n          -  At least 1 episode of anal intercourse with another man within 6 months of study entry\r\n\r\n        Inclusion Criteria for WSM:\r\n\r\n          -  At least 1 episode of unprotected vaginal sex within 6 months of study entry\r\n\r\n        Exclusion Criteria For All Participants:\r\n\r\n          -  Current enrollment in another HIV vaccine or prevention trial\r\n\r\n          -  History of adverse reaction to acyclovir\r\n\r\n          -  Current or planned use of famiciclovir, valacyclovir, or acyclovir for genital HSV.\r\n             Use of short-course antiviral therapy for herpes zoster after enrollment is allowed.\r\n\r\n          -  Known plans for travel away from study site for more than 2 months\r\n\r\n        Exclusion Criteria for MSM:\r\n\r\n          -  In a mutually monogamous relationship with an HIV uninfected partner throughout the\r\n             past 2 years\r\n\r\n          -  Reported sex at birth as female\r\n\r\n        Exclusion Criteria for WSM:\r\n\r\n          -  Pregnancy at screening or enrollment\r\n      ","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","sponsor_type":"NIH","conditions":"HIV Infections|HIV Seronegativity|Herpes Genitalis","interventions":[{"intervention_type":"Drug","name":"Drug: Acyclovir","description":"400 mg tablet taken orally twice daily"},{"intervention_type":"Drug","name":"Drug: Acyclovir placebo","description":"Oral tablet taken twice daily"}],"outcomes":[{"outcome_type":"primary","measure":"Serologically confirmed HIV infection","time_frame":"Throughout study"},{"outcome_type":"secondary","measure":"Occurrence and frequency of genital ulcers","time_frame":"Throughout study"},{"outcome_type":"secondary","measure":"Proportion of doses missed by study participants assigned to twice-daily acyclovir and twice-daily placebo","time_frame":"Throughout study"}]}
{"nct_id":"NCT00214786","start_date":"2005-04-30","phase":"Phase 1","enrollment":4,"brief_title":"Pancreatic Islet Cell Transplantation","official_title":"Pancreatic Islet Cell Transplantation - A Novel Approach to Immunosuppression and Validation of Remote Site Islet Cell Processing, Islet Cell Culture and Two-Layer Preservation","primary_completion_date":"2007-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-07-31","last_update":"2017-06-14","description":"The purpose of this study is to assess a novel approach to immunosuppression in allogenic pancreatic islet cell transplant recipients. In addition, the study aims to assess remote site islet processing with culture for pancreatic islet cell transplantation in human subjects.","other_id":"003-040","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patient has been fully informed and has signed an Institutional Review Board (IRB)\r\n             approved informed consent form and is willing and able to follow study procedures for\r\n             the full 2 years\r\n\r\n          2. Patient is expected to receive an islet cell transplant (up to 3 infusions) for type I\r\n             diabetes mellitus\r\n\r\n               -  Type I diabetes of more than 5 years duration\r\n\r\n               -  Age between 18 and 65\r\n\r\n               -  Unstable diabetes mellitus control, as defined by glucose measurements above 200\r\n                  mg/dL and/or below 80 mg/dL despite adequate medical care\r\n\r\n               -  Hypoglycemia unawareness, as defined by episodes of loss of cognitive function\r\n\r\n               -  Incapacitating signs and symptoms, as defined by the referring physician\r\n\r\n               -  Poor control of HbA1c > 8%\r\n\r\n               -  Psychogenically able to comply, in the opinion of the investigator\r\n\r\n          3. Female patients of childbearing potential must have a negative urine or serum\r\n             pregnancy test upon hospitalization or within 7 days prior to enrollment and have\r\n             agreed to utilize effective birth control throughout the study as well as for 6 weeks\r\n             following study completion.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Patients meeting any of the following criteria will be excluded from study participation.\r\n\r\n          1. Patient has previously received or is receiving an organ or bone marrow transplant\r\n\r\n          2. Patient has a known hypersensitivity to Tacrolimus, sirolimus, daclizumab, or CellCept\r\n\r\n          3. Patient is pregnant or lactating\r\n\r\n          4. Patient has participated in a blinded trial or participated in a trial involving a\r\n             non-marketed (investigational) drug within 3 months of enrollment\r\n\r\n          5. Patient has participated in a trial involving a marketed drug or an infusion device\r\n             within 30 days of the start of the trial\r\n\r\n          6. Glomerular filtration rate (GLOFIL) < 60 mL/min\r\n\r\n          7. Serum Creatinine > 1.6 mg/dL consistently\r\n\r\n          8. Body mass index > 30\r\n\r\n          9. Autoimmune thyroiditis\r\n\r\n         10. Malignancy other than basal cell carcinoma or squamous cell carcinoma\r\n\r\n         11. Radiographic evidence of pulmonary infection\r\n\r\n         12. Evidence of liver disease\r\n\r\n         13. Portal hypertension\r\n\r\n         14. Active infections\r\n\r\n         15. Hypercoagulable states (history of recurrent venous thrombosis, defined thrombophilia)\r\n\r\n         16. Bleeding / coagulation disorders\r\n\r\n         17. Basal insulin C-Peptide > 0.3 ng/dL\r\n\r\n         18. Insulin C-peptide > 0.3 ng/dL during stimulation test\r\n\r\n         19. HbA1c > 12%\r\n\r\n         20. Insulin requirement > 1 IU/kg/day\r\n\r\n         21. Seropositivity for Human immunodeficiency virus (HIV), hepatitis B virus (HBV),\r\n             hepatitis C virus (HCV), Human T-cell leukemia virus-1 (HTLV-1)\r\n\r\n         22. Abnormal Pap smear in the last two months, active gynecological infection\r\n\r\n         23. Positive exercise or chemical tolerance test\r\n\r\n         24. Steroid dependence\r\n\r\n         25. Substance/alcohol abuse\r\n\r\n         26. Untreated proliferating diabetic retinopathy aa) Purified protein derivative (PPD)\r\n             conversion or positive PPD without isonicotinic acid hydrazide (INH) bb) No Primary\r\n             care physician or primary care physician less than 6 months cc) Smoking in the last 6\r\n             months dd) Abnormal Complete Blood Count (CBC) / Hemoglobin < 12 g/dL ee)\r\n             Macroalbuminuria > 300 mg/24 hours ff) History of thyroid disease other than\r\n             autoimmune disease gg) Untreated hyperlipidemia - Total Cholesterol (TC) > 240 mg/dL,\r\n             Triglycerides (TGC) > 200 mg/dL, Low Density Lipoprotein (LDL) > 140 mg/dL hh)\r\n             Untreated hyponatremia, hypokalemia, hypercalcemia, hypocalcemia ii) Iodine contrast\r\n             allergy jj) Prostate Specific Antigen (PSA) > 4 kk) Panel Reactive Antibody (PRA) >\r\n             20% ll) Active peptic ulcer disease/gallstones/hemangioma mm) Abnormal mammogram\r\n      ","sponsor":"Baylor Research Institute","sponsor_type":"Other","conditions":"Type 1 Diabetes","interventions":[{"intervention_type":"Biological","name":"Biological: Islet cell transplantation","description":"Allogenic islet transplantation"}],"outcomes":[{"outcome_type":"secondary","measure":"Incidence of Hypoglycemic Episodes","time_frame":"12 months after transplantation","description":"Blood glucose <70 mg/dl, number of times reported per month"},{"outcome_type":"secondary","measure":"The Number of Islet Cell Infusions Needed to Achieve Insulin Independence","time_frame":"12 months after transplantation"},{"outcome_type":"secondary","measure":"Change of Insulin Requirements in Patients Who Did Not Become Insulin Independent","time_frame":"12 months after transplantation","description":"Percentage of insulin requirement at month 12 against that at baseline in the patients who did not achieve insulin independence. The percentage less than 100% indicates that subjects reduced insulin requirements 12 months after islet transplantation when compared with those at pre-transplant, while the parentage more than 100% represents that patients needed higher amount of exogenous insulin 12 months after islet transplantation."},{"outcome_type":"secondary","measure":"Islet Cell Mass Obtained After Remote Site Processing","time_frame":"At transplantation","description":"The sum of Islet mass obtained after transport using the two-layer preservation method, remote site processing and islet culture. Islet mass as defined by Islet Equivalent per kilogram recipient body weight."},{"outcome_type":"primary","measure":"Achievement of Insulin Independence at 12-month Post Transplant","time_frame":"12 months post transplant","description":"To assess the number of patients who achieve insulin independence at 12-month after islet cell transplantation"},{"outcome_type":"secondary","measure":"Presence or Absence of Hypoglycemic Unawareness","time_frame":"12 months after transplantation","description":"Number of patients who achieved absence of hypoglycemic unawareness"},{"outcome_type":"secondary","measure":"Renal Function","time_frame":"12 months after transplantation","description":"Glomerular filtration rate measured by sodium iothalamate I-125 injection (GLOFIL)"},{"outcome_type":"secondary","measure":"Morbidity Related to the Immunosuppression Regimen","time_frame":"12 months after transplantation","description":"Number of participants who experienced serious adverse events related to immunosuppression regimen"},{"outcome_type":"secondary","measure":"Morbidity Related to the Islet Cell Infusion","time_frame":"12months after transplantation","description":"Number of participants who experienced serious adverse events related to islet cell infusion"},{"outcome_type":"secondary","measure":"The Quality of Life of the Recipients Measured With the RAND 36-item Short Form Health Survey","time_frame":"12 months after transplantation","description":"Averaged score in subscales of 'physical functioning', 'Role limitations due to emotional problems', 'energy/fatigue', 'emotional well-being', 'social functioning', 'pain' and 'general health' in the RAND 36-item short form health survey (SF-36). Full scale range is 0-100 for all subscales with 100 as the best outcome and 0 as the worst outcome."}]}
{"nct_id":"NCT00160589","start_date":"2005-04-30","phase":"Phase 4","enrollment":729,"brief_title":"LEADER (LEvocetirizine And DEsloratadine in Allergic Rhinitis)","official_title":"A Multicentre, Double-blind, Parallel, Randomized, Placebo-controlled Study : Evaluation of the Efficacy and Safety of Levocetirizine 5 mg and Desloratadine 5 mg Administered Orally as Capsules Once Daily, in the Morning, Over 2 Weeks in Patients Suffering From Allergic Rhinitis (AR)","primary_completion_date":"2005-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2005-09-30","last_update":"2013-12-16","description":"Two weeks study to evaluate the efficacy and safety of Levocetirizine and Desloratadine in patients suffering from Allergic Rhinitis (AR)","other_id":"A00401","allocation":"Randomized","intervention_model":"Parallel Assignment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  At least 2-year history of Allergic Rhinitis that became symptomatic during the annual\r\n             grass pollen season.\r\n\r\n          -  A skin test for grass pollens positive:\r\n\r\n          -  Have rhinitis symptoms of such severity that the mean T4SS over the baseline period\r\n             must be 6.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Have an associated asthma requiring corticosteroid treatment,\r\n\r\n          -  Have an atopic dermatitis or an urticaria requiring an antihistamine treatment or the\r\n             administration of oral or topical corticosteroids,\r\n      ","sponsor":"UCB Pharma","sponsor_type":"Industry","conditions":"Rhinitis, Allergic, Perennial","interventions":[{"intervention_type":"Drug","name":"Drug: Levocetirizine"}],"outcomes":[{"outcome_type":"primary","measure":"Mean change from baseline of T4SS (four symptoms score) over two weeks of treatment"},{"outcome_type":"secondary","measure":"Clinical efficacy over the first and over two weeks of treatment measured by symptoms (scored and individuals); Onset of action; Safety"}]}
{"nct_id":"NCT00240604","start_date":"2005-04-30","phase":"Phase 3","enrollment":100,"brief_title":"Prevention of Corticosteroid-induced Glucose Intolerance","official_title":"Treatment With Rosiglitazone for the Prevention of Glucose Intolerance in Patients Treated With Corticosteroids","primary_completion_date":"2013-12-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2015-10-31","last_update":"2011-09-14","description":"Glucose intolerance is frequent and serious complication of corticosteroid therapy. the aim of the study is to examine the hypothesis that co treatment with rosiglitazone can prevent glucose intolerance in patients treated with corticosteroids.","other_id":"7-29.10.04-HMO-CTIL","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  corticosteroid treatment\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  congestive heart failure pedal edema\r\n      ","sponsor":"Hadassah Medical Organization","sponsor_type":"Other","conditions":"Glucose Intolerance","interventions":[{"intervention_type":"Drug","name":"Drug: Rosiglitazone","description":"4 mg rosiglitazone per day"}],"outcomes":[{"outcome_type":"primary","measure":"plasma glucose concentration","time_frame":"6 months"}]}
{"nct_id":"NCT00116272","start_date":"2005-04-30","enrollment":830,"brief_title":"Organization of Teratology Information Services (OTIS) Autoimmune Diseases in Pregnancy Project","official_title":"OTIS Autoimmune Diseases in Pregnancy Project","primary_completion_date":"2014-06-30","study_type":"Observational","rec_status":"Completed","completion_date":"2014-06-30","last_update":"2015-09-21","description":"The purpose of the study is to evaluate the effect of etanercept when used in the first trimester of pregnancy with respect to major structural birth defects of newborns. This is an observational study only - no investigational product is used.","other_id":"20040246","observational_model":"Cohort","sampling_method":"Non-Probability Sample","gender":"All","population":"Cohort 1: Exposure Cohort (300 subjects) Cohort 2: Matched diseased control Cohort (300\r\n        subjects) Cohort 3: Non-diseased Control Cohort (300 subjects)","criteria":"\n        Cohort 1 Inclusion Criteria: Eligible subjects will be currently pregnant women residing in\r\n        the US or Canada who have had any exposure to etanercept for treatment of Rheumatoid\r\n        Arthritis (RA), Juvenile RA, Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsoA) or\r\n        Psoriasis (PsO) at any time during the first trimester of pregnancy which is defined as the\r\n        period between first day of the last menstrual period (i.e., within two weeks of\r\n        conception) up to and including the 12th week after the first day of the last menstrual\r\n        period (LMP) - Eligible subjects must have documentation of an exposure to etanercept\r\n        during the first trimester of pregnancy.\r\n\r\n        Cohort 2 Inclusion Criteria: Eligible subjects will be currently pregnant women residing in\r\n        the US or Canada who have not taken etanercept or any TNF antagonist for treatment of RA,\r\n        JRA, AS, PsoA or PsO at any time in the current pregnancy or within two months prior to the\r\n        first day of the last menstrual period (LMP).\r\n\r\n        Cohort 3 Inclusion Criteria: Eligible subjects will be pregnant women who were residing in\r\n        the US or Canada who had not been diagnosed with RA, JRA, AS, PsoA or PsO and had not been\r\n        exposed to a known human teratogen during the index pregnancy.\r\n      ","sponsor":"Amgen","sponsor_type":"Industry","conditions":"Pregnancy","interventions":[{"intervention_type":"Drug","name":"Drug: Etanercept","description":"Pregnant women previously exposed to etanercept during the first trimester. Etanercept was not administered in this non-interventional study."}],"outcomes":[{"outcome_type":"secondary","measure":"Percentage of Infants at One Year of Age With Small for Gestational Age Head Circumference","time_frame":"1 year after birth","description":"Postnatal growth deficiency defined as ≤ 10th centile for chronological age. Age adjusted for gestational age at delivery if child was less than 12 months of age at postnatal measurement, unadjusted if ≥ 12 months of age at postnatal measurement."},{"outcome_type":"secondary","measure":"Percentage of Infants With Reported Serious or Opportunistic Infections Through One Year","time_frame":"From birth to 1 year"},{"outcome_type":"secondary","measure":"Percentage of Infants Diagnosed With Any Malignancy Through One Year of Age","time_frame":"From birth to 1 year"},{"outcome_type":"primary","measure":"Percentage of Infants With Major Birth Defects in Pregnancies Ending With Live-born Infants","time_frame":"From birth through 1 year of age","description":"A major structural defect is defined as a defect which has either cosmetic or functional significance to the child (e.g., a cleft lip). The Registry used the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system, with some specified modifications that are appropriate for cohort studies as opposed to case-control studies."},{"outcome_type":"primary","measure":"Percentage of Infants With Major Birth Defects in All Pregnancies","time_frame":"From birth through 1 year of age","description":"A major structural defect is defined as a defect which has either cosmetic or functional significance to the child (e.g., a cleft lip). The Registry used the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system, with some specified modifications that are appropriate for cohort studies as opposed to case-control studies."},{"outcome_type":"secondary","measure":"Percentage of Infants With Any 3 or More Minor Birth Defects","time_frame":"From birth through 1 year of age","description":"A minor structural defect is defined as a defect which occurs in less than 4 percent of the population but which has neither cosmetic nor functional significance to the child (e.g., complete 2,3 syndactyly of the toes). The Registry used the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system, with some specified modifications that are appropriate for cohort studies as opposed to case-control studies."},{"outcome_type":"secondary","measure":"Percentage of Infants With a Specific Pattern of Any 3 or More Minor Birth Defects","time_frame":"From birth through 1 year of age","description":"A minor structural defect is defined as a defect which occurs in less than 4 percent of the population but which has neither cosmetic nor functional significance to the child (e.g., complete 2,3 syndactyly of the toes). A pattern is defined as at least the same 3 specific minor malformations occurring in at least two infants in the exposed group."},{"outcome_type":"secondary","measure":"Percentage of Pregnancies Ending in Spontaneous Abortion","time_frame":"9 months","description":"Computed using Kaplan-Meier estimate at 20 weeks gestation, accounting for left truncation due to varying time in gestation at enrollment. In multiple pregnancies ending in at least 1 live-born infant, the live birth outcome is included in the analysis. In multiples ending in no live birth outcomes, the spontaneous abortion is counted as 1 event."},{"outcome_type":"secondary","measure":"Percentage of Participants With Pre-term Delivery","time_frame":"9 months","description":"A pretem delivery is defined as prior to 37 weeks gestation. Computed using Kaplan-Meier estimate at 37 weeks' gestation, accounting for left truncation due to varying time in gestation at enrollment. Multiple births are excluded."},{"outcome_type":"secondary","measure":"Gestational Age at Delivery (GAD) of Live Births","time_frame":"At birth"},{"outcome_type":"secondary","measure":"Birth Weight Among Full Term Infants","time_frame":"At birth"},{"outcome_type":"secondary","measure":"Birth Length Among Full Term Infants","time_frame":"At birth"},{"outcome_type":"secondary","measure":"Birth Head Circumference Among Full Term Infants","time_frame":"At birth"},{"outcome_type":"secondary","measure":"Percentage of Infants With Small for Gestational Age Birth Weight","time_frame":"At birth","description":"Small for gestational age is defined as ≤ 10th percentile for sex and gestational age using National Center for Health Statistics (NCHS) / Center for Disease Control (CDC) growth curves."},{"outcome_type":"secondary","measure":"Percentage of Infants With Small for Gestational Age Birth Length","time_frame":"At birth","description":"Small for gestational age is defined as ≤ 10th percentile for sex and gestational age using National Center for Health Statistics (NCHS) / Center for Disease Control (CDC) growth curves."},{"outcome_type":"secondary","measure":"Percentage of Infants With Small for Gestational Age Birth Head Circumference","time_frame":"At birth","description":"Small for gestational age is defined as ≤ 10th percentile for sex and gestational age using National Center for Health Statistics (NCHS) / Center for Disease Control (CDC) growth curves."},{"outcome_type":"secondary","measure":"Postnatal Weight Percentile at One Year","time_frame":"1 year after birth"},{"outcome_type":"secondary","measure":"Postnatal Length Percentile at One Year","time_frame":"1 year after birth"},{"outcome_type":"secondary","measure":"Postnatal Head Circumference Percentile at One Year","time_frame":"1 year after birth"},{"outcome_type":"secondary","measure":"Percentage of Infants at One Year of Age With Small for Gestational Age Weight","time_frame":"1 year after birth","description":"Postnatal growth deficiency defined as ≤ 10th centile for chronological age. Age adjusted for gestational age at delivery if child was less than 12 months of age at postnatal measurement, unadjusted if ≥ 12 months of age at postnatal measurement."},{"outcome_type":"secondary","measure":"Percentage of Infants at One Year of Age With Small for Gestational Age Length","time_frame":"1 year after birth","description":"Postnatal growth deficiency defined as ≤ 10th centile for chronological age. Age adjusted for gestational age at delivery if child was less than 12 months of age at postnatal measurement, unadjusted if ≥ 12 months of age at postnatal measurement."},{"outcome_type":"secondary","measure":"Percentage of Infants With Abnormal Results on Ages and Stages Questionnaire (ASQ)","time_frame":"1 year after birth","description":"The ASQ-3 evaluates 5 domains of development: communication, gross motor, fine motor, problem solving, and personal-social. Each domain has a set of 6 items and parents rate the most appropriate answer for the presence of each skill: \"Yes,\" \"Sometimes,\" \"Not Yet,\" with point values of 10, 5, or 0, respectively. Each domain question set is totaled independently and compared against statistically derived cutoffs that are set at 2 standard deviations below the mean. The percentage of infants below the cut-off or close to the cutoff (borderline) is reported."}]}
{"nct_id":"NCT00734383","start_date":"2005-04-30","phase":"Phase 2/Phase 3","enrollment":137,"brief_title":"Propofol Cardioprotection for Type II Diabetics","official_title":"PRO-TECT II: Propofol Cardioprotection for Type II Diabetics","primary_completion_date":"2012-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-06-30","last_update":"2012-07-13","description":"The purpose of this study is to determine if an intravenous anesthetic with antioxidant properties will protect the heart of diabetic patients from injury while undergoing coronary bypass surgery.","other_id":"H04-70456","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":19,"maximum_age":29,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patients with and without Type II Diabetes Mellitus\r\n\r\n          2. Hemodynamically Stable\r\n\r\n          3. Non urgent Coronary Bypass Grafting utilizing Cardiopulmonary Bypass\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Age less than 18 or greater than 80 years of age\r\n\r\n          2. refuse informed consent\r\n\r\n          3. Co-existing valvular heart disease\r\n\r\n          4. Acute or evolving myocardial infarction\r\n\r\n          5. hypersensitivity to propofol or formulation component\r\n\r\n          6. Use of NSAIDs, Vitamins C or E within 5 to 7 days of surgery\r\n      ","sponsor":"University of British Columbia","sponsor_type":"Other","conditions":"Myocardial Injury","interventions":[{"intervention_type":"Drug","name":"Drug: Propofol","description":"Propofol cardioprotection : Ten minutes prior to initiation of CPB, we will stop delivery of isoflurane, inject 1 mg/kg iv and then continuously infuse propofol at 120g/kg/min IV until 15 min after release of the aortic cross clamp (reperfusion)."},{"intervention_type":"Drug","name":"Drug: Propofol","description":"Volatile Anesthetic preconditioning : Anesthesia will be maintained using an inspired concentration of isoflurane between 0.5-2% before, during, and after CPB, without administration of propofol. For ten minutes prior to the initiation of CPB we will deliver Isoflurane 2.5% end tidal then resume maintenance anesthesia as described."}],"outcomes":[{"outcome_type":"primary","measure":"Perioperative Plasma 15 f2t isoprostane, a biologically active marker of oxidative stress","time_frame":"24 hours post operation"},{"outcome_type":"secondary","measure":"Perioperative (includes coronary sinus levels) plasma antioxidant concentration; ET-1, TNF alpha, Troponin I, peroxynitrite; gene and protein expression of eNOS and iNOS; hemodynamics","time_frame":"24 hours post operation"}]}
{"nct_id":"NCT00137787","start_date":"2005-04-30","phase":"Phase 3","enrollment":51,"brief_title":"Comparing Ciprofloxacin (CPFX) With Cefepime (CFPM) in Febrile Neutropenic Patients With Hematologic Diseases","official_title":"Randomized Controlled Trial Comparing Ciprofloxacin With Cefepime in Febrile Neutropenic Patients With Hematologic Diseases","primary_completion_date":"2009-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-05-31","last_update":"2018-06-26","description":"The aim of this study is to investigate whether intravenous ciprofloxacin is as effective as cefepime for the initial treatment of febrile neutropenia developed in patients with hematologic diseases.","other_id":"C-SHOT 0402","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":15,"maximum_age":79,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Hematologic disease\r\n\r\n          -  Ages between 15 and 79 years\r\n\r\n          -  Axillary temperature of 38.0 C or greater on one occasion or of 37.5 to 37.9 C lasting\r\n             for more than 1 hour\r\n\r\n          -  Absolute neutrophil count of less than 500/microL\r\n\r\n          -  T-Bil level less than 2.0 times the upper limit of normal\r\n\r\n          -  Cre level less than 1.5 times the upper limit of normal\r\n\r\n          -  Written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Past history of allergic reaction to the study drug\r\n\r\n          -  Positive for HIV antibody\r\n\r\n          -  Pregnant or lactating women\r\n\r\n          -  Family history of auditory disturbance\r\n\r\n          -  Having received systemic antibacterial therapy within 14 days\r\n\r\n          -  Receiving systemic antifungal or antiviral therapy except fluconazole or acyclovir for\r\n             cases undergoing transplantation\r\n\r\n          -  No recovery of neutrophil count of 1,000/microL or higher from the previous febrile\r\n             episode\r\n\r\n          -  On treatment with ketoprofen\r\n\r\n          -  On treatment with sodium valproate\r\n\r\n          -  Septic shock\r\n      ","sponsor":"Center for Supporting Hematology-Oncology Trials","sponsor_type":"Other","conditions":"Febrile Neutropenia","interventions":[{"intervention_type":"Drug","name":"Drug: ciprofloxacin"},{"intervention_type":"Drug","name":"Drug: cefepime"}],"outcomes":[{"outcome_type":"primary","measure":"Treatment efficacy","time_frame":"At 7 days after initiating therapy"},{"outcome_type":"secondary","measure":"Treatment efficacy","time_frame":"At 21 days"},{"outcome_type":"secondary","measure":"Toxicity","time_frame":"During the follow-up period"}]}
{"nct_id":"NCT00244218","start_date":"2005-04-30","phase":"Phase 1","enrollment":57,"brief_title":"Response to Phenylketonuria to Tetrahydrobiopterin (BH4)","official_title":"Response to Phenylketonuria to Tetrahydrobiopterin (BH4)","primary_completion_date":"2009-03-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2015-01-31","last_update":"2021-09-21","description":"The purpose of this study is to determine whether tetrahydrobiopterin (BH4)is effective in treating patients with PKU.","other_id":"01-269","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":10,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subject and/or parent or guardian must be capable of understanding and providing\r\n             written informed consent\r\n\r\n          -  Subjects must have Phenylketonuria (PKU)or hyperphenylalaninemia (HPA), defined as\r\n             baseline blood Phe levels of >600 umol/L\r\n\r\n          -  Subjects must be at least 10 years of age, and may be of either gender and any ethnic\r\n             group\r\n\r\n          -  Female subjects of childbearing potential must agree to use adequate birth control or\r\n             refrain from sexual activity throughout study participation\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Female subjects who are pregnant or breastfeeding\r\n\r\n          -  Subjects who have concurrent diseases or conditions that require medication or\r\n             treatment\r\n\r\n          -  Subjects who require concomitant treatment with any drug known to inhibit folate\r\n             synthesis\r\n\r\n          -  Subjects who have been treated with any investigational drug within 30 days\r\n      ","sponsor":"The University of Texas Medical Branch, Galveston","sponsor_type":"Other","conditions":"Phenylketonuria","interventions":[{"intervention_type":"Drug","name":"Drug: tetrahydrobiopterin (BH4)","description":"Either placebo or tetrahydrobiopterin (BH4) , 10mg/kg/day will be given for three months. Then the patient will be given three additional months of open label BH4 at the same rate."}],"outcomes":[{"outcome_type":"primary","measure":"Blood Phe level decrease by 30%","time_frame":"9 months"}]}
{"nct_id":"NCT00295971","start_date":"2005-04-30","phase":"Phase 1","enrollment":21,"brief_title":"Donor Stem Cell Transplant in Treating Young Patients With Myelodysplastic Syndrome, Leukemia, Bone Marrow Failure Syndrome, or Severe Immunodeficiency Disease","official_title":"Stem Cell Enriched, T Cell Depleted Haplocompatible Peripheral Blood Transplantation for Children With Myelodysplastic Disease, Leukemia, Marrow Failure Syndromes, or Severe Immunodeficiency Diseases","primary_completion_date":"2011-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-12-31","last_update":"2012-11-12","description":"RATIONALE: Giving chemotherapy and total body irradiation before a donor bone marrow transplant or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving antithymocyte globulin and removing the T cells from the donor cells before transplant may stop this from happening. PURPOSE: This phase I trial is studying the side effects and best dose of donor T cells and antithymocyte globulin when given together with chemotherapy and total-body irradiation in treating young patients who are undergoing T-cell depleted donor stem cell transplant for myelodysplastic syndrome, leukemia, bone marrow failure syndrome, or severe immunodeficiency disease.","other_id":"CDR0000462168","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":1,"maximum_age":17,"population":"","criteria":"\n        DISEASE CHARACTERISTICS:\r\n\r\n          -  Diagnosis of one of the following:\r\n\r\n               -  Acute lymphoblastic leukemia in  2nd remission or delayed remission induction\r\n\r\n               -  High-risk myelodysplastic syndromes\r\n\r\n                    -  Refractory anemia with excess blasts (RAEB)\r\n\r\n                    -  RAEB in transformation\r\n\r\n               -  Chronic myelogenous leukemia in second chronic phase\r\n\r\n                    -  No accelerated phase (> 5% blasts in marrow)\r\n\r\n               -  Juvenile myelomonocytic leukemia\r\n\r\n               -  Acute nonlymphoblastic leukemia in > 1st remission or induction failure and < 30%\r\n                  blasts in marrow\r\n\r\n               -  Severe aplastic anemia, defined as absolute neutrophil count < 500/mm^3 and\r\n                  platelet and/or red blood cell transfusion dependent\r\n\r\n                    -  Unresponsive to immunosuppressive therapy\r\n\r\n                    -  No Fanconi's anemia\r\n\r\n               -  Congenital marrow aplasias unresponsive to cytokines and transfusion dependent\r\n\r\n               -  Inherited immunodeficiency disease involving neutrophils or lymphocytes,\r\n                  including any of the following:\r\n\r\n                    -  Chediak-Higashi disease\r\n\r\n                    -  Wiskott-Aldrich syndrome\r\n\r\n                    -  Combined immunodeficiency disease (Nezelof's)\r\n\r\n                    -  Hyper IgM syndrome\r\n\r\n          -  No relapsed disease\r\n\r\n          -  Haplocompatible related donor, including parent, cousin, aunt, uncle, grandparent,\r\n             half-sibling, or sibling ( 12 years of age), available\r\n\r\n               -  2 or 3 HLA antigen mismatch\r\n\r\n               -  At least a 3 HLA antigen genotypic match\r\n\r\n               -  No closely matched related or unrelated donor available in sufficient time to do\r\n                  the transplant\r\n\r\n        PATIENT CHARACTERISTICS:\r\n\r\n          -  No active hepatitis or cytomegalovirus infection\r\n\r\n          -  Cardiac ejection fraction  30%\r\n\r\n          -  Creatinine clearance  70 mL/min\r\n\r\n          -  DLCO  70% of predicted\r\n\r\n          -  No active infection\r\n\r\n          -  No HIV positivity\r\n\r\n        PRIOR CONCURRENT THERAPY:\r\n\r\n          -  See Disease Characteristics\r\n      ","sponsor":"University of California, San Francisco","sponsor_type":"Other","conditions":"Congenital Amegakaryocytic Thrombocytopenia|Leukemia|Myelodysplastic Syndromes|Severe Congenital Neutropenia","interventions":[{"intervention_type":"Biological","name":"Biological: anti-thymocyte globulin"},{"intervention_type":"Biological","name":"Biological: therapeutic allogeneic lymphocytes"},{"intervention_type":"Drug","name":"Drug: fludarabine phosphate"},{"intervention_type":"Drug","name":"Drug: thiotepa"},{"intervention_type":"Procedure","name":"Procedure: allogeneic bone marrow transplantation"},{"intervention_type":"Procedure","name":"Procedure: allogeneic hematopoietic stem cell transplantation"},{"intervention_type":"Procedure","name":"Procedure: in vitro-treated peripheral blood stem cell transplantation"},{"intervention_type":"Radiation","name":"Radiation: total-body irradiation"}],"outcomes":[{"outcome_type":"primary","measure":"Engraftment at 4 weeks post bone marrow transplantation through 100 days","time_frame":"100 days"},{"outcome_type":"secondary","measure":"Survival assessed monthly for 6 months, every 3 months for 2 years, every 6 months for 1 year, and then yearly for 5 years post transplantation","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Disease-free survival and infection assessed monthly for 6 months, every 3 months for 2 years, every 6 months for 1 year, and then yearly for 5 years post transplantation","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Graft-versus-host disease assessed monthly for 6 months, every 3 months for 2 years, every 6 months for 1 year, and then yearly for 5 years post transplantation","time_frame":"2 years"},{"outcome_type":"secondary","measure":"CD4 count in blood < 100/mm³ at 12 weeks","time_frame":"12 weeks"}]}
{"nct_id":"NCT00178464","start_date":"2005-03-31","phase":"Phase 1","enrollment":11,"brief_title":"Aspirin Prophylaxis in Sickle Cell Disease","official_title":"Aspirin Prophylaxis in Sickle Cell Disease","primary_completion_date":"2009-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-11-30","last_update":"2017-11-06","description":"Neurologic complications secondary to cerebrovascular damage are prevalent in children with sickle cell disease. These patients experience both clinically overt cerebrovascular accidents and \"silent infarctions\" demonstrated by magnetic resonance imaging (MRI). They are also at risk for neurocognitive abnormalities.We hypothesize that daily, low-dose aspirin therapy will safely diminish the incidence and progression of cognitive deficits as well as the predisposition to overt and silent stroke in children with homozygous sickle cell disease (Hgb SS) or hemoglobin S Beta Zero Thalassemia (Hgb SB-0 Thal). In order to optimize the design of a future trial to test this hypothesis, we propose a pilot study to test the safety and tolerability of aspirin in young children with sickle cell disease.","other_id":"09661","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":2,"maximum_age":7,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  1. Children ages 2 - 7.99 years with a diagnosis of Hb SS or Hb S0 thalassemia,\r\n             documented by hemoglobin electrophoresis and a complete blood count (CBC). 2.\r\n             Influenza vaccination during the previous year or intended before the upcoming flu\r\n             season. 3. Evidence of past infection with, or immunization against, varicella. 4.\r\n             Negative pregnancy tests in girls of childbearing potential. 5. Informed consent\r\n             signed by the parent or legal guardian.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  1. Prior history of overt stroke or cerebral hemorrhage. 2. Known history of allergic\r\n             reaction to aspirin. 3. History of Reye's syndrome 4. Diagnosis of G-6-PD deficiency\r\n             or von Willebrand's disease 5. Prolongation of the bleeding time or abnormal closure\r\n             time, prothrombin time (PT), or partial thromboplastin time (PTT). 6. Active\r\n             gastrointestinal (GI) bleeding or a history of GI bleeding. 7. Hepatic disease (AST or\r\n             ALT >2x upper limit of normal, Direct bilirubin > 1.5 mg/dL) or renal disease\r\n             (creatinine >2x upper limit of normal or 2 mg/dl, whichever is smaller). The exclusion\r\n             criteria laboratory study ranges have been specified as greater than 2 times the upper\r\n             limit of normal. 8. Hypertension (BP >95% for age and height). 9. Current treatment\r\n             with chronic transfusion therapy. 10. Evidence of hemorrhage on MRI. 11. A mean TCD\r\n             velocity > 200 cm/sec. in the middle cerebral artery (MCA) or internal carotid artery\r\n             (ICA). 12. Evidence of Moyamoya syndrome on MRA. 13. Evidence of pregnancy. 14.\r\n             Evidence of an inability to comply with testing procedures. 15. Inability to provide\r\n             informed consent.\r\n      ","sponsor":"University of Rochester","sponsor_type":"Other","conditions":"Sickle Cell Disease","interventions":[{"intervention_type":"Drug","name":"Drug: aspirin","description":"81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months."}],"outcomes":[{"outcome_type":"primary","measure":"Number of Adverse Events","time_frame":"12 months","description":"Occurrence of individual adverse events and relationship to aspirin"},{"outcome_type":"secondary","measure":"# of Subjects Recruited Over Time, Screening Failures, Withdrawal Rates;Compliance (Pill Counts & Labs);Changes in Performance on Neurocognitive Tests; Changes in MRI/MRA; Changes in TCD;Incidences of Stroke, Acute Chest Crises, and Pain Crises","time_frame":"12 months"},{"outcome_type":"primary","measure":"Number of Serious Adverse Events","time_frame":"12 months","description":"Occurrence of individual serious adverse events and relationship to aspirin"}]}
{"nct_id":"NCT00108134","start_date":"2005-03-31","phase":"Phase 2","enrollment":60,"brief_title":"Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Superficial Basal Cell Carcinoma","official_title":"A Multi-Center, Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Study to Determine the Safety of PEP005 0.0025%, 0.01% and 0.05% Gel With Two Treatment Schedules, Day 1 & 2 or Day 1 & 8 Applications to Superficial Basal Cell Carcinoma","primary_completion_date":"2006-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2006-03-31","last_update":"2008-12-24","description":"The purpose of this study is to determine whether topical application of PEP005 is safe for the treatment of superficial basal cell carcinoma.","other_id":"PEP005-003","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female patients at least 18 years of age\r\n\r\n          -  One sBCC on the arm, shoulder, chest, face, neck, abdomen, leg, back or scalp suitable\r\n             for surgical excision\r\n\r\n          -  Histological confirmation of sBCC based on the central dermatopathologist's evaluation\r\n             of the punch biopsy\r\n\r\n          -  Longest pre- and post-biopsy diameter of the sBCC lesion between 4 mm and 15 mm\r\n\r\n          -  Maximum thickness of 4 mm of the sBCC lesion\r\n\r\n          -  Laboratory values within the reference ranges as defined by the central laboratory or\r\n             \"out of range\" test results that are clinically acceptable to the Investigator\r\n\r\n          -  Ability to follow study instructions and likely to complete all study requirements\r\n\r\n          -  Written informed consent\r\n\r\n          -  Male patients with a female partner of childbearing potential must use an approved\r\n             form of contraception during the study and for 4 weeks after the last visit\r\n\r\n          -  Agreement from the patient to allow photographs of all selected lesions (including the\r\n             face) to be taken and used as part of the study data package\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Location of the outside margin of the anticipated treatment area of the sBCC selected\r\n             for treatment:\r\n\r\n               1. within 10 cm of a malignant lesion that will require treatment during the study\r\n\r\n               2. within 5 cm of an incompletely healed wound\r\n\r\n               3. within 2 cm of a pre-malignant lesion (e.g. actinic keratosis lesion)\r\n\r\n               4. within 2 cm of the open eyelid margins\r\n\r\n               5. within 1 cm of a scar or an area previously treated with surgical excision\r\n\r\n               6. on the lips\r\n\r\n               7. on the breast\r\n\r\n               8. on the hand or foot\r\n\r\n               9. in a skin crease\r\n\r\n          -  sBCC lesion selected for treatment requiring Mohs micrographic surgery\r\n\r\n          -  Presence of known or suspected metastatic disease\r\n\r\n          -  Histological evidence of actinic keratoses or nBCC in the screening visit biopsy\r\n             sample\r\n\r\n          -  Histological evidence of BCC with micro-nodular features or squamous metaplasia,\r\n             sclerosing BCC (i.e. desmoplastic or morphoeic), or BCC with perineural involvement in\r\n             the screening visit biopsy sample\r\n\r\n          -  History of recurrence of the sBCC lesion\r\n\r\n          -  History or evidence of skin diseases which would interfere with evaluation of the\r\n             treatment area (e.g. eczema, unstable psoriasis, xeroderma pigmentosa)\r\n\r\n          -  Known sensitivity to any of the ingredients in the study medication\r\n\r\n          -  A cosmetic or therapeutic procedure (e.g. use of liquid nitrogen, surgical excision,\r\n             curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing)\r\n             within 10 cm of the selected sBCC lesion during the 3 months prior to study entry or\r\n             anticipated treatment within 10 cm of the selected lesion during the study\r\n\r\n          -  Treatment with 5-fluorouracil, imiquimod, diclofenac or photodynamic therapy:\r\n\r\n               1. of lesions located within 10 cm of the selected sBCC lesion during the 3 months\r\n                  prior to study entry or\r\n\r\n               2. anywhere during the 4 weeks prior to study entry or anticipated treatment during\r\n                  the study\r\n\r\n          -  Use of acid-containing products (e.g. salicylic acids or fruit acids, such as alpha\r\n             and beta hydroxy acids and glycolic acids), topical retinoids or light chemical peels\r\n             within 10 cm of the selected sBCC lesion during the 3 months prior to study entry or\r\n             anticipated treatment in this same area during the study\r\n\r\n          -  Treatment with immuno-modulators (e.g. cyclosporine, prednisone, methotrexate,\r\n             infliximab or other biological agents), cytotoxic drugs (e.g. vinblastine,\r\n             cyclophosphamide, azathioprine, chlorambucil, methotrexate), or interferon/interferon\r\n             inducers during the 4 weeks prior to study entry or anticipated treatment during the\r\n             study\r\n\r\n          -  Treatment with psoralen plus UVA or use of UVB therapy during the 6 months prior to\r\n             study entry or anticipated treatment during the study\r\n\r\n          -  Use of systemic retinoids (e.g. isotretinoin, acitretin) during the 6 months prior to\r\n             study entry or anticipated treatment during the study\r\n\r\n          -  Anticipated excessive or prolonged exposure to ultraviolet light (e.g. sunlight,\r\n             tanning beds) or use of topical salves, creams or ointments to the selected lesion\r\n             during the study\r\n\r\n          -  Anticipated need for hospitalization or non-dermatological surgery during the study\r\n\r\n          -  Concurrent disease that suppresses the immune system (e.g. HIV) or uncontrolled\r\n             systemic disease (e.g. uncontrolled hypertension, poorly controlled diabetes)\r\n\r\n          -  Current evidence of chronic alcohol or drug abuse\r\n\r\n          -  Current enrolment in an investigational drug or device study or participation in such\r\n             a study within 30 days of entry into this study\r\n\r\n          -  Diagnosis of xeroderma pigmentosa or Gorlin Syndrome (i.e. Basal Cell Nevus Syndrome)\r\n\r\n          -  A condition or situation which in the Investigator's opinion may put the patient at\r\n             significant risk, may confound the study results, or may interfere significantly with\r\n             the patient's participation in the study\r\n\r\n          -  Females of child bearing potential (a female is considered of childbearing potential\r\n             unless she is postmenopausal, i.e., no menses for at least 12 consecutive months, or\r\n             is without a uterus)\r\n      ","sponsor":"Peplin","sponsor_type":"Industry","conditions":"Basal Cell Carcinoma","interventions":[{"intervention_type":"Drug","name":"Drug: PEP005"}],"outcomes":[{"outcome_type":"primary","measure":"Safety"},{"outcome_type":"secondary","measure":"Efficacy"}]}
{"nct_id":"NCT01000558","start_date":"2005-03-31","enrollment":939,"brief_title":"SWOG-8947 Collecting and Storing Blood Samples From Patients With Previously Untreated Non-Hodgkin Lymphoma","official_title":"Central Lymphoma Serum Repository Protocol","primary_completion_date":"2011-07-31","study_type":"Observational","rec_status":"Completed","completion_date":"2011-07-31","last_update":"2013-05-20","description":"RATIONALE: Collecting and storing samples of blood from patients with cancer to test in the laboratory may help the study of cancer in the future. PURPOSE: This research study is collecting and storing blood samples from patients with previously untreated non-Hodgkin lymphoma.","other_id":"CDR0000390329","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients consenting to 8947 banking of blood and serum","criteria":"\n        DISEASE CHARACTERISTICS:\r\n\r\n          -  Diagnosis of non-Hodgkin lymphoma\r\n\r\n               -  Previously untreated disease\r\n\r\n               -  Patients must meet the eligibility criteria and be registered to a currently\r\n                  active Southwest Oncology Group-coordinated treatment protocol for previously\r\n                  untreated non-Hodgkin lymphoma\r\n\r\n        PATIENT CHARACTERISTICS:\r\n\r\n          -  Not specified\r\n\r\n        PRIOR CONCURRENT THERAPY:\r\n\r\n          -  See Disease Characteristics\r\n      ","sponsor":"Southwest Oncology Group","sponsor_type":"Other","conditions":"Lymphoma","interventions":[{"intervention_type":"Other","name":"Other: biologic sample preservation procedure"}],"outcomes":[{"outcome_type":"primary","measure":"Establishment of a Centralized Lymphoma Serum Repository for the Southwest Oncology Group","time_frame":"July 2011"}]}
{"nct_id":"NCT00592670","start_date":"2005-03-31","phase":"N/A","enrollment":48,"brief_title":"Hypoglycemia Associated Autonomic Failure in Type 1 DM","official_title":"Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 6","primary_completion_date":"2007-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-10-31","last_update":"2014-12-11","description":"It is unclear what effect selective serotonin reuptake inhibitors (SSRIs) have on hypoglycemia. Thus, the American Hospital Formulary Service recommends careful monitoring of blood glucose levels in all patients with diabetes initiating or discontinuing SSRIs (Katz et al., 1996). Because of the increased prevalence of depression in those with diabetes, it is critical to discover what affect the antidepressant therapy may have on counterregulatory responses to hypoglycemia. This study hypothesizes that chronic administration of SSRIs may result in a blunted counterregulatory response to hypoglycemia, thereby leaving individuals more susceptible to hypoglycemia.","other_id":"IRB#040912-HAAF-T1DM-Q6","allocation":"Randomized","intervention_model":"Parallel Assignment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  16 (8 males, 8 females) healthy volunteers aged 18-45 yr\r\n\r\n          -  34 (17 males, 17 females) type 1 diabetes volunteers aged 18-45 yr\r\n\r\n          -  Body mass index 21-30 kg  m-2\r\n\r\n          -  Normal bedside autonomic function\r\n\r\n          -  Normal results of routine blood test to screen for hepatic, renal, and hematological\r\n             abnormalities\r\n\r\n          -  Female volunteers of childbearing potential: negative HCG pregnancy test\r\n\r\n          -  Volunteers over 40 years old: normal heart tracing recorded while resting and walking\r\n             on the treadmill\r\n\r\n          -  For those with type 1 diabetes: HbA1c > 7.0%\r\n\r\n          -  For those with type 1 diabetes: had diabetes for 2-15 years\r\n\r\n          -  For those with type 1 diabetes: no clinical evidence of diabetic tissue complications\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior history of poor health: any current or prior disease condition that alters\r\n             carbohydrate metabolism and prior cardiac events and/or evidence for cardiac disease\r\n\r\n          -  Hemoglobin of less than 12 g/dl\r\n\r\n          -  Abnormal results following screening tests\r\n\r\n          -  Pregnancy\r\n\r\n          -  Subjects with any indication of depression, anxiety, bipolar, panic, or eating\r\n             disorders\r\n\r\n          -  Subjects with a past medical history or family history of mania or bipolar disorders\r\n\r\n          -  Subjects unable to give voluntary informed consent\r\n\r\n          -  Subjects with a recent medical illness\r\n\r\n          -  Subjects with known liver or kidney disease\r\n\r\n          -  Subjects taking steroids\r\n\r\n          -  Subjects taking beta blockers\r\n\r\n          -  Subjects on anticoagulant drugs, anemic, or with known bleeding diseases\r\n      ","sponsor":"Vanderbilt University","sponsor_type":"Other","conditions":"Type 1 Diabetes","interventions":[{"intervention_type":"Drug","name":"Drug: Fluoxetine","description":"20 mg fluoxetine orally one per day for 1 week, 40 mg fluoxetine orally once per day for one week, 80 mg Fluoxetine orally for remaining 4 weeks of treatment"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"20 mg placebo pill taken orally once per day for one week, 40 mg placebo pill taken orally one per day for one week, 80 mg placebo pill taken orally once per day for remaining 4 weeks."}],"outcomes":[{"outcome_type":"primary","measure":"Catecholamine measures","time_frame":"6 weeks"}]}
{"nct_id":"NCT00349193","start_date":"2005-03-31","phase":"Phase 2","enrollment":306,"brief_title":"A Study to Evaluate the Effectiveness, Tolerability and Safety of Laquinimod","official_title":"A Multinational, Multicenter Randomized Double-Blind, Parallel-Group, Placebo-Controlled Study, to Evaluate the Efficacy, Tolerability and Safety of Two Doses of, Oral Laquinimod in Relapsing Remitting (R-R) Multiple Sclerosis (MS) Subjects","primary_completion_date":"2006-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2006-08-31","last_update":"2011-04-08","description":"Teva is developing laquinimod tablets as a new oral treatment for MS. Laquinimod has immunomodulating properties. In a previous clinical study laquinimod showed evidence of biological activity by reducing the number of acute brain lesions. The duration of the current study is 36 weeks.","other_id":"LAQ/5062","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Willing and able to give written informed consent\r\n\r\n          2. Confirmed MS diagnosis as defined by the McDonald criteria\r\n\r\n          3. R-R MS disease course.\r\n\r\n          4. At least one gadolinium-enhanced lesion on screening MRI\r\n\r\n          5. Women of child-bearing potential must practice a reliable method of birth control.\r\n\r\n          6. Must understand the requirements of the study and agree to comply with the study\r\n             protocol.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Subjects who suffer from any form of progressive MS.\r\n\r\n          2. Any condition which the investigator feels may interfere with participation in the\r\n             study.\r\n\r\n          3. Subjects with a clinically significant or unstable medical or surgical condition that\r\n             would preclude safe and complete study participation,\r\n\r\n          4. Subjects who received any investigational medication, immunosuppressives or cytotoxic\r\n             agents within 6 months prior to screening\r\n\r\n          5. Previous treatment with immunomodulators within two months prior to screening\r\n      ","sponsor":"Teva Pharmaceutical Industries","sponsor_type":"Industry","conditions":"Relapsing Remitting Multiple Sclerosis","interventions":[{"intervention_type":"Drug","name":"Drug: laquinimod 0.3","description":"laquinimod 0.3mg"},{"intervention_type":"Drug","name":"Drug: laquinimod 0.6","description":"laquinimod 0.6mg"},{"intervention_type":"Other","name":"Other: Placebo","description":"Blinded Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"Reduction of brain lesions in the last 4 months of the study","time_frame":"36 weeks"},{"outcome_type":"secondary","measure":"Relapse rate","time_frame":"36 weeks"}]}
{"nct_id":"NCT00601887","start_date":"2005-03-31","phase":"N/A","enrollment":48,"brief_title":"Bioequivalency Study of Meloxicam Tablets Under Fed Conditions","official_title":"A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of 15 mg Meloxicam Tablets Under Fed Conditions","primary_completion_date":"2005-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2005-04-30","last_update":"2018-01-23","description":"The objective of this study was the bioequivalence of a Roxane Laboratories' Meloxicam tablets, 15 mg, to Mobic Tablets, 15 mg (Boehringer Ingelheim) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.","other_id":"MELO-T15-PVFD-1","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  No clinically significant abnormal findings on the physical examination, medical\r\n             history, or clinical laboratory results during screening.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Positive test for HIV, Hepatitis B, or Hepatitis C.\r\n\r\n          -  Treatment with known enzyme altering drugs.\r\n\r\n          -  History of allergic or adverse response to Meloxicam or any comparable or similar\r\n             product.\r\n      ","sponsor":"Roxane Laboratories","sponsor_type":"Industry","conditions":"Inflammation","interventions":[{"intervention_type":"Drug","name":"Drug: Meloxicam"}],"outcomes":[{"outcome_type":"primary","measure":"Bioequivalence","time_frame":"Baseline, Two period, Fourteen day washout"}]}
{"nct_id":"NCT00496808","start_date":"2005-03-31","phase":"N/A","enrollment":69,"brief_title":"Neoadjuvant Herceptin for Ductal Carcinoma In Situ of the Breast","official_title":"Neoadjuvant Herceptin for Ductal Carcinoma In Situ of the Breast","primary_completion_date":"2010-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-11-30","last_update":"2020-09-23","description":"Primary Objectives: - To determine the effect of a single dose of Herceptin (trastuzumab) on the proliferation rate of Her-2/neu over-expressing ductal carcinoma in situ (DCIS) - To evaluate the effect of a single dose of Herceptin on the apoptotic index of Her-2/neu over-expressing DCIS","other_id":"2004-0701","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. All patients with histologic confirmation of DCIS (TisN0M0) that is Her-2/neu 3+\r\n             positive by immunohistochemistry (IHC) and/or positive for Her-2 gene amplification by\r\n             fluorescence in situ hybridization (FISH) will be eligible for the study.\r\n\r\n          2. Patients must sign informed consent indicating that they are aware of the\r\n             investigational nature of the study, in keeping with institutional policy.\r\n\r\n          3. Those patients with history of other contralateral non-invasive and invasive breast\r\n             and non-breast malignancies are eligible to participate unless they have previously\r\n             received a doxorubicin dose of more than 400 mg/m2.\r\n\r\n          4. All patients should have adequate bone marrow function, as defined by peripheral\r\n             granulocyte count of > 1,500/mm3, and platelet count > 100,000 mm3. Patients must have\r\n             adequate liver function, with bilirubin within normal laboratory values. In addition,\r\n             patients should have adequate renal function, defined as serum creatinine < 2.0 mg/dl.\r\n\r\n          5. Patients with intact primary tumors will be eligible for this study. Patients who have\r\n             had their diagnostic biopsy at an outside facility but still have measurable disease\r\n             on presentation will be eligible.\r\n\r\n          6. Patients with history of cardiac arrhythmia will be eligible for study after being\r\n             seen by cardiology and deemed good candidates for participation.\r\n\r\n          7. Women of child bearing potential must have a negative urine or serum pregnancy test.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients with a current known invasive breast cancer are not eligible for this study.\r\n\r\n          2. All patients who are Her-2/neu negative will be ineligible for the study.\r\n\r\n          3. Patients with history of congestive heart failure will be excluded.\r\n      ","sponsor":"M.D. Anderson Cancer Center","sponsor_type":"Other","conditions":"Ductal Carcinoma In Situ","interventions":[{"intervention_type":"Drug","name":"Drug: Herceptin (Trastuzumab)","description":"8 mg/kg IV Over 90 Minutes"}],"outcomes":[{"outcome_type":"primary","measure":"Percent Change in Proliferation as Measured by Ki-67","time_frame":"Before and after single dose of Herceptin approximately 21 days before surgery for ductal carcinoma in situ (DCIS), up to 4 weeks","description":"Percent Change in Proliferation as measured by Ki-67 (% nuclei stained). Comparison of proliferation rates of Her-2/neu overexpressing cells before and after treatment with Herceptin per Participant where absolute change defined as difference of increase/decrease. Proliferation rate evaluated by immunohistochemistry using paraffin-embedded sections and monoclonal antibody for ki-67."},{"outcome_type":"primary","measure":"Number of Participants Achieving Documented Change in Proliferation","time_frame":"Before and after single dose of Herceptin approximately 21 days before DCIS surgery, up to 4 weeks","description":"Proliferation rate and apoptotic index measured on core biopsy specimen and resection specimen from each participants. To compare Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and CD4+ T-cell response in each participant observed at pre- and post-treatment times, paired analysis was performed using Student's t-test. Nonparametric Wilcoxon rank sum test was used to compare data between groups."},{"outcome_type":"secondary","measure":"Mean Percent of Ki-67","time_frame":"Before and after single dose of Herceptin approximately 21 days before DCIS surgery, up to 4 weeks","description":"Mean percent of Ki-67 (% nuclei stained) at immunohistochemical staining performed for biomarkers. Tissue sections from diagnostic core biopsy tissue that contains DCIS before treatment and from corresponding tissues that contain DCIS from the surgical resection obtained after a single dose of Herceptin."}]}
{"nct_id":"NCT00299507","start_date":"2005-03-31","phase":"Phase 3","enrollment":240,"brief_title":"Anecortave Acetate in Patients With Exudative Age-related Macular Degeneration (AMD)","official_title":"Anecortave Acetate 15 mg Administered Every 3 Months Versus Anecortave Acetate 15 mg Administered Every 6 Months Versus Anecortave Acetate 30 mg Administered Every 6 Months in Patients With Exudative Age-Related Macular Degeneration (AMD)","primary_completion_date":"2008-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-04-30","last_update":"2012-11-28","description":"The purpose of this study was to evaluate the effect of the dose concentration and administration frequency of Anecortave Acetate (AA) on visual acuity (VA) and lesion size when administered by posterior juxtascleral depot (PJD) every 3 months (AA 15 mg) or 6 months (AA 15 mg, AA 30 mg) in patients with exudative age-related macular degeneration (AMD).","other_id":"C-04-59","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Clinical diagnosis of exudative AMD and a primary or recurrent (after laser\r\n             photocoagulation) subfoveal choroidal neovascularization (CNV) lesion.\r\n\r\n          -  Other protocol-defined inclusion criteria may apply.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Less than 50 years of age.\r\n\r\n          -  Other protocol-defined exclusion criteria may apply.\r\n      ","sponsor":"Alcon Research","sponsor_type":"Industry","conditions":"Macular Degeneration","interventions":[{"intervention_type":"Drug","name":"Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL","description":"One 0.5 mL posterior juxtascleral depot injection at 3 or 6 month intervals"},{"intervention_type":"Drug","name":"Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL","description":"One 0.5 mL posterior juxtascleral depot injection at 6 month intervals"},{"intervention_type":"Other","name":"Other: Anecortave Acetate Vehicle","description":"One 0.5 mL sham injection at 6 month intervals"}],"outcomes":[{"outcome_type":"primary","measure":"Mean change in best-corrected visual acuity (BCVA) at Month 12 from baseline","time_frame":"Month 12"},{"outcome_type":"secondary","measure":"Mean change in lesion growth at Month 12 from baseline","time_frame":"Month 12"}]}
{"nct_id":"NCT00169416","start_date":"2005-03-31","phase":"Phase 3","enrollment":43,"brief_title":"Evaluation Of Valaciclovir In Patients With Chickenpox","official_title":"Clinical Evaluation of Valaciclovir Hydrochloride: 256U87 in Patients With Chickenpox - Open Uncontrolled Study.","primary_completion_date":"2005-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2005-08-31","last_update":"2015-04-15","description":"This study will assess the safety and efficacy, and the pharmacokinetics of aciclovir and valaciclovir in children with chickenpox following oral administration of valaciclovir, for the purpose of seeking approval of valaciclovir HCl for the treatment of chickenpox.","other_id":"HS2101951","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":1,"maximum_age":11,"population":"","criteria":"\n        Inclusion criteria:\r\n\r\n          -  Subjects aged 1 year to less than 12 years with a clinical diagnosis of chickenpox\r\n             within 48 hours of the onset of the rash.\r\n\r\n        Exclusion criteria:\r\n\r\n          -  History of hypersensitivity reactions.\r\n\r\n          -  Impaired hepatic or renal function.\r\n\r\n          -  Gastrointestinal dysfunction.\r\n\r\n          -  Serious underlying disease.\r\n\r\n          -  Weigh over 40kg.\r\n\r\n          -  Vaccinated for chickenpox.\r\n      ","sponsor":"GlaxoSmithKline","sponsor_type":"Industry","conditions":"Varicella","interventions":[{"intervention_type":"Drug","name":"Drug: valaciclovir HCl granules"}],"outcomes":[{"outcome_type":"primary","measure":"Plasma aciclovir concentrations approximately 1 - 2 hours post-dose, and/or 1, 2, 4 and 6 hours following administration of the valaciclovir HCl granules 25mg/kg -dose."},{"outcome_type":"secondary","measure":"Plasma valaciclovir concentrations approximately 1 - 2 hours post-dose, and/or 1, 2, 4 and 6 hours following administration of the valaciclovir HCl granules 25mg/kg -dose."}]}
{"nct_id":"NCT00223054","start_date":"2005-03-31","enrollment":200,"brief_title":"Polymorphism of the Cytochrome P450-system in Renal Transplants","official_title":"Polymorphism of the Cytochrome P450-system and the MDR-system in Renal Transplants Receiving the Immunosuppressive Drugs Tacrolimus, Sirolimus, Everolimus or Cyclosporine A","primary_completion_date":"2006-06-30","study_type":"Observational","rec_status":"Completed","completion_date":"2006-10-31","last_update":"2011-08-04","description":"In this study the researchers want to investigate genetic polymorphisms of cytochrome 450 enzymes and the multiple drug resistance (MDR) gene in renal transplant patients to look for differences in dosing of immunosuppressive drugs (tacrolimus, sirolimus, everolimus, cyclosporine A). All patients who receive one of these drugs can be included and drug blood trough levels, dosing and genetics are compared.","other_id":"004","time_perspective":"Retrospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"maximum_age":70,"population":"Patinets after kidney transplantation","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Renal transplant patients receiving one or more of the following drugs:\r\n\r\n               -  tacrolimus\r\n\r\n               -  sirolimus\r\n\r\n               -  everolimus\r\n\r\n               -  cyclosporin A\r\n\r\n               -  fluvastatin\r\n\r\n          -  Informed consent given by the patient\r\n      ","sponsor":"University Hospital Schleswig-Holstein","sponsor_type":"Other","conditions":"Function of Renal Transplant","interventions":[{"intervention_type":"Drug","name":"Drug: tacrolimus","description":"retrospective analyze of drug levels in comparison to polymorphism"},{"intervention_type":"Drug","name":"Drug: sirolimus","description":"retrospective of drug blood trough levels in comparison to polymorphism of enzymes of drug metabolism"},{"intervention_type":"Drug","name":"Drug: everolimus","description":"retrospective of drug blood trough levels in comparison to polymorphism of enzymes of drug metabolism"},{"intervention_type":"Drug","name":"Drug: cyclosporin A","description":"retrospective of drug blood trough levels in comparison to polymorphism of enzymes of drug metabolism"}],"outcomes":{}}
{"nct_id":"NCT00215111","start_date":"2005-03-31","phase":"N/A","enrollment":102,"brief_title":"Role of Carbohydrate Modification in Weight Management Among Obese Children","official_title":"Role of Carbohydrate Modification in Weight Management Among Obese Children","primary_completion_date":"2008-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-06-30","last_update":"2015-02-05","description":"The purpose of this study is to test the hypothesis that a low-carbohydrate diet and a low-glycemic load diet will improve body mass index and result in more body fat loss than a control diet among overweight children ages 7 to 12. In addition this study is also designed to test the safety of diets with modified carbohydrate content as compared to a conventional weight management diet among younger overweight children.","other_id":"02819-8","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":7,"maximum_age":12,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age 7-12 years\r\n\r\n          -  Body mass index >95th percentile and BMI z-score no greater than 2.65\r\n\r\n          -  Normal fasting blood glucose of less than 100 mg/dL\r\n\r\n          -  Age-appropriate cognitive and behavioral skills\r\n\r\n          -  Absence of developmental or physical disabilities\r\n\r\n          -  Capability to function independently in group exercise sessions\r\n\r\n          -  Commitment of parent/guardian to attend scheduled meetings for 12-month period\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Active cardiac, pulmonary, renal, liver, or gastrointestinal disease (pancreatitis,\r\n             cholelithiasis, inflammatory bowel disease), diabetes, untreated thyroid disease,\r\n             hypertension, hyperlipidemia\r\n\r\n          -  Chronic infections\r\n\r\n          -  Uncompensated or labile mental illness\r\n\r\n          -  Chronic or intermittent use of corticosteroids\r\n\r\n          -  Specific medications that may alter lipid, glucose, bone metabolism or appetite\r\n      ","sponsor":"Children's Hospital Medical Center, Cincinnati","sponsor_type":"Other","conditions":"Childhood Obesity","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Low carbohydrate, reduced glycemic load, and a control diet"}],"outcomes":[{"outcome_type":"primary","measure":"The outcomes listed below will be obtained at baseline,3-month,","time_frame":"3 month"},{"outcome_type":"primary","measure":"6-month and 12-month assessments unless otherwise noted,body weight,","time_frame":"6-month and 12-month"},{"outcome_type":"primary","measure":"height,body mass index,waist circumference,percent body fat,","time_frame":"baseline, 3-month, 6-month and 12-month"},{"outcome_type":"primary","measure":"adipose mass,lean body mass,bone mineral density,fasting lipid profile,","time_frame":"baseline, 3-month, 6-month and 12-month"},{"outcome_type":"primary","measure":"fasting insulin,fasting glucose,2-hour glucose (baseline and 3-month assessment),","time_frame":"baseline, 3-month, 6-month and 12-month"},{"outcome_type":"secondary","measure":"physical activity (3-day physical activity records and pedometer readings)","time_frame":"3-month, 6-month and 12-month"},{"outcome_type":"secondary","measure":"compliance with behavioral intervention (frequency rewards were earned)","time_frame":"weekly"},{"outcome_type":"secondary","measure":"attendance at group and individual sessions during initial 3-month intervention","time_frame":"3-month, 6-month and 12-month"},{"outcome_type":"secondary","measure":"Sexual Maturity Rating","time_frame":"baseline"},{"outcome_type":"secondary","measure":"Hunger/Satiety assessment (Three-Factor Eating Questionnaire)","time_frame":"baseline, 3-month, 6-month and 12-month"},{"outcome_type":"secondary","measure":"Parent/guardian perception of success for each diet assignment prior to their child being randomized to a diet group","time_frame":"baseline"}]}
{"nct_id":"NCT00133926","start_date":"2005-03-31","phase":"Phase 2","enrollment":1094,"brief_title":"Prevention of Pre-Term Birth by Treatment of Periodontal Disease","official_title":"Prevention of Pre-Term Birth by Treatment of Periodontal Disease During Pregnancy - The Smile Study","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2008-06-30","last_update":"2007-04-05","description":"The aim of the study is to investigate, in an Australian population of pregnant women, whether the treatment of periodontal disease during pregnancy prevents pre-term birth and other complications of pregnancy. Dental screening and periodontal treatment protocols have been based on standard techniques employed by hygienists that can be readily applied to the general obstetric population.","other_id":"353577","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":16,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Pregnant women, with single pregnancies, between 12 and 20 weeks gestation\r\n\r\n          -  Periodontal disease defined as periodontal pocketing at a threshold of 4mm or more at\r\n             10% or more of sites\r\n\r\n          -  Agree to receive periodontal treatment\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Unable to attend for treatment\r\n\r\n          -  Less than 16 years of age\r\n\r\n          -  Have a fetus with an abnormality that predisposes the pregnancy to pre-term birth\r\n\r\n          -  Multiple pregnancy\r\n\r\n          -  Cardiac disease that would require antibiotic therapy\r\n\r\n          -  Have fewer than 20 teeth\r\n\r\n          -  Present for antenatal care after 20 weeks gestation\r\n\r\n          -  Unable to understand the implications of participation in the trial\r\n\r\n          -  Currently receiving periodontal treatment\r\n      ","sponsor":"King Edward Memorial Hospital","sponsor_type":"Other","conditions":"Periodontal Diseases|Premature Birth|Pre-Eclampsia","interventions":[{"intervention_type":"Procedure","name":"Procedure: Treatment of periodontal disease"}],"outcomes":[{"outcome_type":"primary","measure":"Rate of pre-term birth"},{"outcome_type":"secondary","measure":"Rate of fetal growth restriction"},{"outcome_type":"secondary","measure":"Rate of pre-eclampsia"},{"outcome_type":"secondary","measure":"Rate of complications of pre-term birth"}]}
{"nct_id":"NCT00173875","start_date":"2005-03-31","phase":"Phase 2","enrollment":108,"brief_title":"Iressa as a First-Line Treatment in Chemonaive Patients With Inoperable Non-Small Cell Lung Cancer","official_title":"A Phase II Study to Evaluate the Efficacy and Safety of Iressa as a First-Line Treatment in Chemonaive Patients With Inoperable Non-Small Cell Lung Cancer (NSCLC)","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-07-31","last_update":"2007-07-30","description":"The purpose of this study is to assess the overall response rate to Iressa as a first-line treatment in chemonaive patients with inoperable Non-Small Cell Lung Cancer (NSCLC)","other_id":"940107","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically or cytologically confirmed stage IIIB/IV NSCLC\r\n\r\n          -  No immediate need for palliative radiotherapy and No prior chemotherapy\r\n\r\n          -  age > 20 Y/O\r\n\r\n          -  ECOG PS: 0 - 2\r\n\r\n          -  ANC >2000\r\n\r\n          -  PLT >100k\r\n\r\n          -  Hb > 10\r\n\r\n          -  total bilirubin < 2.0 mg/dL\r\n\r\n          -  serum creatinine < 2 mg/dl\r\n\r\n          -  SGPT and SGOT < 2.5 ULN, alkaline phosphatase < 5 ULN\r\n\r\n          -  life expectancy >6mos.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  If the patients have brain metastases or receive radiotherapy, the disease must be\r\n             stable for more than 6 weeks after the last dose of radiotherapy\r\n\r\n          -  2nd malignancies\r\n\r\n          -  Unable to swallow tablets\r\n\r\n          -  Patients (M/F) with reproductive potential not implementing adequate contraceptive\r\n             measurements\r\n\r\n          -  Pregnant or lactating patients\r\n\r\n          -  Participation in other clinical trials within 30 days of study entry\r\n\r\n          -  Major systemic disease which in the investigator's opinion might confound the clinical\r\n             trial\r\n      ","sponsor":"National Taiwan University Hospital","sponsor_type":"Other","conditions":"Non-Small Cell Lung Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Iressa"}],"outcomes":[{"outcome_type":"primary","measure":"The primary objective of this study is to assess the overall response rate to Iressa as a first-line treatment in chemonaive patients with inoperable Non-Small Cell Lung Cancer","time_frame":"2005~2007"},{"outcome_type":"secondary","measure":"To evaluate 1) Individual response rate 2) Time to progression 3) Overall survival (OS) at year1 4) Progression free survival (PFS) at year1 5) Toxicity","time_frame":"2005~2007"}]}
{"nct_id":"NCT01326338","start_date":"2005-03-31","phase":"Phase 3","enrollment":100,"brief_title":"Nitazoxanide for the Treatment of Prolonged Diarrhea in Children","official_title":"Multi-Center, Double-Blind, Placebo-Controlled Study of Nitazoxanide Suspension in the Treatment of Prolonged Diarrhea in Children","primary_completion_date":"2006-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2006-05-31","last_update":"2011-03-30","description":"The purpose of this study was to determine the efficacy of nitazoxanide suspension compared to placebo in treating prolonged diarrhea in children.","other_id":"RM02-3019","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":1,"maximum_age":11,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with diarrhea 3 days but <30 days duration.\r\n\r\n          -  No visible blood in stool.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Use of any antibacterial, antiparasitic or antiviral drugs within 5 days of\r\n             enrollment.\r\n\r\n          -  Females who are pregnant, suspected of being pregnant or breastfeeding.\r\n\r\n          -  Serious systemic disorders incompatible with the study.\r\n\r\n          -  History of hypersensitivity to nitazoxanide.\r\n\r\n          -  Patients in whom the possibility of receiving placebo and not being able to receive\r\n             immediately an effective treatment will be incompatible with the severity of the\r\n             patient's illness according to the investigator's judgment.\r\n\r\n          -  Patients known to have or suspected of having AIDS or other immune deficiencies.\r\n      ","sponsor":"Romark Laboratories L.C.","sponsor_type":"Industry","conditions":"Diarrhea","interventions":[{"intervention_type":"Drug","name":"Drug: Nitazoxanide","description":"Nitazoxanide Oral Suspension 100 mg/5 ml for patients aged 1-3 years twice daily for 3 days or Nitazoxanide Oral Suspension 200 mg/10 ml for patients aged 4-11 years twice daily for 3 days"}],"outcomes":[{"outcome_type":"primary","measure":"Time from first dose to resolution of symptoms","time_frame":"Up to 17 days","description":"Resolution of symptoms defined as resolution of all gastrointestinal symptoms associated with prolonged diarrhea at enrollment including abdominal pain or tenderness, distention, etc. with the patient not requiring anti-motility or other palliative treatment. Symptom resolution must be maintained for at least 72 hours to be considered valid."}]}
{"nct_id":"NCT00281073","start_date":"2005-03-31","phase":"Phase 1/Phase 2","enrollment":95,"brief_title":"Intra-Cardiac Echocardiography Guided Cardioversion(ICE-CHIP) Study","official_title":"A Sequential Phase I - Phase II Pilot Study to Compare Cardiac Imaging Capabilities of ICE With TEE Followed by a Randomized Comparison of ICE Guided Cardioversion With Conventional Cardioversion Strategy in Patients With Atrial Fibrillation","primary_completion_date":"2008-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-07-31","last_update":"2011-05-11","description":"This is a sequential phase 1 and phase 2 study to evaluate the efficacy of intracardiac echocardiography to detect septal and left atrial pathology as compared to transesophageal echocardiography (Phase 1) and its value in a management strategy for immediate cardioversion during cardiac catheterization procedures in patients with atrial fibrillation as compared to a conventional strategy delaying cardioversion till full anticoagulation is established for a three weeks (Phase 2). Phase 1 will enroll 100 patients at 12 centers; these patients will be undergoing clinically indicated TEE & cardiac catheterization procedures. After review of Phase 1 results by an independent DSMB & the investigators that establish efficacy of ICE, Phase 2 will be initiated. Phase 2 will enroll 300 patients in 15 centers; these patients with atrial fibrillation will be undergoing clinically indicated cardiac catheterization procedures and have a clinical indication for cardioversion. Patients will be randomized to ICE guided cardioversion strategy or a conventional strategy employing three weeks of full anticoagulation before cardioversion. ICE imaging will be used to identify a low risk group for immediate cardioversion. A composite primary study endpoint that will include mortality and major morbidity including stroke and bleeding complications will be used. This study will examines two hypotheses in AF patients undergoing invasive cardiac procedures: Hypothesis 1: That ICE has comparable efficacy to TEE in visualization of left atrial pathology or septal defects that can predispose patients to stroke. This will be evaluated during the Phase I component of the study. Hypothesis 2: That ICE can identify low risk patients in whom immediate cardioversion during the procedure is safe and comparably effective to electrical cardioversion performed based on a conventional strategy of a minimum of 3 weeks of preceding anticoagulation therapy. Low risk patients are expected to have an acceptably low incidence rate of stroke, transient ischemic attack (TIA), peripheral embolism, and major hemorrhagic events following electrical cardioversion. This will be evaluated during the Phase II component of the study, after the Phase I objective is achieved.","other_id":"2004-01","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Inclusion Criteria for the Phase I Component\r\n\r\n          1. Patients with spontaneous AF\r\n\r\n          2. Patients with or without structural Heart Disease.\r\n\r\n          3. Men or Women aged 18 years or older.\r\n\r\n          4. Patients undergoing an invasive catheterization procedure including right heart\r\n             catheterization.\r\n\r\n          5. Patients who give an informed consent for participation in the study.\r\n\r\n          6. Patients who have undergone a trans-thoracic echocardiogram within the last 14 days\r\n             showing absence of intracardiac thrombi.\r\n\r\n          7. Patients who have undergone a trans-esophageal echocardiogram within the last 48\r\n             hours.\r\n\r\n        Inclusion Criteria for the Phase II Component\r\n\r\n          1. Patients with spontaneous AF\r\n\r\n          2. Patients with or without structural Heart Disease.\r\n\r\n          3. Men or Women aged 18 years or older.\r\n\r\n          4. Patients undergoing an invasive catheterization procedure including right heart\r\n             catheterization.\r\n\r\n          5. Patients who give an informed consent for participation in the study.\r\n\r\n          6. Patients who have undergone a trans-thoracic echocardiogram within the last 14 days\r\n             showing absence of intracardiac thrombi.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Exclusion Criteria for the Phase I Component\r\n\r\n          1. Patients in whom placement of an ICE catheter for adequate atrial visualization is\r\n             technically not feasible.\r\n\r\n          2. Women of child bearing potential, in whom pregnancy cannot be excluded.\r\n\r\n          3. Patients with any medical condition or social circumstance, which in the opinion of\r\n             the investigator, would make the patient's successful completion of the study doubtful\r\n\r\n        Exclusion Criteria for the Phase II Component 1. Patients anticoagulated for > 7 days. 2.\r\n        Patients who have had a cardioembolic event within the last 1-month. 3. Patients requiring\r\n        urgent cardioversion due to hemodynamic instability. 4. Patients in whom placement of an\r\n        ICE catheter for adequate atrial visualization is technically not feasible. 5. Patients\r\n        with contraindications for Warfarin. 6. Women of child bearing potential, in whom pregnancy\r\n        cannot be excluded. 7. Patients who need anticoagulation withdrawn due to an elective\r\n        procedure 8. Patients with any medical condition or social circumstance, which in the\r\n        opinion of the investigator would make the patient's successful completion of the study\r\n        doubtful.\r\n\r\n        -\r\n      ","sponsor":"EP MedSystems","sponsor_type":"Industry","conditions":"Atrial Fibrillation","interventions":[{"intervention_type":"Device","name":"Device: Intra-Cardiac Echocardiography guided Cardioversion","description":"Intracardiac Echo and TEE"},{"intervention_type":"Device","name":"Device: Intracardiac Echo","description":"Intracardiac Echo Viewmate"},{"intervention_type":"Device","name":"Device: ICE","description":"ICE or TEE"}],"outcomes":[{"outcome_type":"primary","measure":"Prevalence of thrombi or spontaneous contrast detected by ICE or TEE","time_frame":"intraoperative","description":"Prevalence of thrombi or spontaneous contrast detected by ICE"}]}
{"nct_id":"NCT00129155","start_date":"2005-02-28","phase":"Phase 2","enrollment":30,"brief_title":"MiniMUD Study - Unrelated Reduced Intensity Conditioning With Treosulfan for Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies","official_title":"Unrelated Reduced Intensity Conditioning With Treosulfan for Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies","study_type":"Interventional","rec_status":"Unknown status","last_update":"2007-10-04","description":"In this study, treosulfan is evaluated for conditioning in allogenic stem cell transplantation. The procedure and the follow-up are the same as in standard allogenic transplant. The donor is unrelated (identical HLA). The graft is haematological peripheral blood stem cell. The conditioning with reduced intensity is: fludarabine (from day -6 to day -2), treosulfan (from day -6 to day -4) and thymoglobuline (from day -2 to day -1).","other_id":"2003.332","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  AGE: >= 18 years and <= 65 years\r\n\r\n          -  Patients with a too high transplant-related mortality (TRM) after standard\r\n             transplantation (multiple myeloma, chronic lymphoid leukemia, non Hodgkin's lymphoma,\r\n             myelodysplasia)\r\n\r\n          -  Patients with visceral contra-indication for standard transplantation:\r\n\r\n               -  cardiac: myocardiopathy; forced expiratory volume (FEV) < 50%;\r\n\r\n               -  respiratory: abnormal carbon monoxide diffusing capacity (DLCO);\r\n\r\n               -  renal: creatinine clearance < 50ml/min;\r\n\r\n               -  hepatic: transaminases and bilirubin > 2 upper normal limit;\r\n\r\n               -  infectious: controlled fungal infection.\r\n\r\n          -  Karnofsky score >= 70%\r\n\r\n          -  Unrelated donor HLA identical (ABC, DRB1; DQB1)\r\n\r\n          -  Signed informed consent\r\n\r\n        Diagnosis :\r\n\r\n        Chronic myelogenous leukemia (CML):\r\n\r\n          -  In first chronic phase, resistant to interferon with or without aracytine or\r\n             refractory or resistant to Glivec\r\n\r\n          -  In complete response (CR) or in 2nd partial response (PR) after being in blastic phase\r\n\r\n        Multiple myeloma (MM):\r\n\r\n          -  Relapse after autograft if the therapeutic response was evaluated to 50%\r\n\r\n        Non-Hodgkin's lymphoma (NHL):\r\n\r\n          -  Mantle cell lymphoma after first relapse but in case of chemosensitivity  50% except\r\n             for high grade lymphoma\r\n\r\n          -  In 2nd CR or PR chemosensitive in response  50% after autograft\r\n\r\n        Chronic lymphocytic leukemia (CLL):\r\n\r\n          -  In 2nd CR or PR or in response  50% after autograft or in 2nd relapse after 2 lines\r\n             of treatment but in case of chemosensitivity  50%\r\n\r\n        Acute myeloid leukemia (AML):\r\n\r\n          -  In 2nd CR or in 1st CR for high risk criteria [high risk criteria defined by: LAM 7;\r\n             leukocytes > 30,000/mm3; chromosomal abnormalities: t(6,9); abnormalities of 11q23,\r\n             17p, 11q, 20q, 21q, -5, del(5q), -7/del7q, del 9q et inv 3q]\r\n\r\n        Acute lymphoblastic leukemia (ALL):\r\n\r\n          -  In 2nd CR or in 1st CR if high risk criteria patients who are defined by chromosomal\r\n             abnormalities t(9,22); t(1,19); t(4,11); abnormalities of 11q23\r\n\r\n        Myelodysplastic syndromes (MDS):\r\n\r\n          -  Patients without prior chemotherapy, with intermediate or high International\r\n             Prognostic Scoring System (IPSS) score and blast cells < 1% in bone marrow (BM)\r\n\r\n          -  CR or PR after chemotherapy for patients with 20 to 30% of blast cells in BM\r\n\r\n          -  Secondary AML patients with a response to chemotherapy (< 30% blasts in BM and < 5% of\r\n             blast cells in blood)\r\n\r\n        For all:\r\n\r\n          -  Adequate contraception in female patients of child bearing potential\r\n      ","sponsor":"Hospices Civils de Lyon","sponsor_type":"Other","conditions":"Hematological Malignancies|Allogeneic Transplantation","interventions":[{"intervention_type":"Drug","name":"Drug: treosulfan"}],"outcomes":[{"outcome_type":"primary","measure":"Overall survival at 1 year"},{"outcome_type":"secondary","measure":"Engraftment evaluation"},{"outcome_type":"secondary","measure":"Acute and chronic graft-versus-host disease incidence and severity"},{"outcome_type":"secondary","measure":"Response rate and survival without progression"},{"outcome_type":"secondary","measure":"Evaluation of conditioning and transplant toxicity"},{"outcome_type":"secondary","measure":"Chimerism evaluation"}]}
{"nct_id":"NCT00538746","start_date":"2005-02-28","phase":"N/A","brief_title":"Effect of Increased Muscular Work During Different Weaning Strategies in Critically Ill Patients","study_type":"Interventional","rec_status":"Unknown status","last_update":"2007-10-03","description":"Most patients admitted to intensive care units require mechanical ventilation. Weaning from assisted/controlled ventilation begins when we recognize that the patient has recovered adeguately from acute respiratory failure. If weaning is delayed, costs are increased, as are the risks of nosocomial pneumonia, cardiac-associated morbility, and death. On the other hand, weaning too soon often results in reintubation, which is associated with complications similar to those of prolonged ventilation. The aim of this trial is to establish an evidence-based approach to weaning and to determine when a patient is ready to be weaned from mechanical ventilation, and what is the best weaning technique.","other_id":"1500","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age higher than 18 yrs\r\n\r\n          2. PaO2/FiO2 greater or equal than 150 with PEEP equal or lower than 10, and minute\r\n             ventilation lower than 15 l/min\r\n\r\n          3. Temperature lower than 38,5C\r\n\r\n          4. Stable hemodynamics: HR 60-125 b/min, SBP 90-160 mmHg without or with dopamine lower\r\n             than 10 gamma/Kg/min or dobutamine lower than 10 gamma/Kg/min, no acute arrythmias\r\n\r\n          5. Hb higher than 8 g/dl\r\n\r\n          6. GCS higher or equal than 9\r\n\r\n          7. The attending physician has to agree that the patient is in stable conditions and\r\n             ready to be weaned from the ventilator\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. presence of chronic neuromuscular diseases\r\n\r\n          2. need of surgical intervention within the next 72 hours\r\n\r\n          3. difficult tracheal intubation\r\n\r\n          4. tracheostomized patients\r\n      ","sponsor":"Universit degli Studi dell'Insubria","sponsor_type":"Other","conditions":"Acute Respiratory Failure","interventions":[{"intervention_type":"Device","name":"Device: BIPAP"},{"intervention_type":"Device","name":"Device: PSV"},{"intervention_type":"Device","name":"Device: PSV + CPAP"}],"outcomes":[{"outcome_type":"primary","measure":"1. Days of intubation 2. Days of mechanical ventilation","time_frame":"28 days"},{"outcome_type":"secondary","measure":"1. The day of eventual tracheostomy 2. Organ Failure 3. The mortality at 28° day 4. Outcome at 6 months","time_frame":"1 year"}]}
{"nct_id":"NCT00228969","start_date":"2005-02-28","phase":"Phase 2","brief_title":"Safety and Efficacy of 333369 in the Treatment of Partial Epilepsy","primary_completion_date":"2006-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2006-05-31","last_update":"2012-08-02","description":"The primary objective of this study is to evaluate the efficacy, safety, and tolerability of 4 daily doses of RWJ-333369 as adjunctive treatment of refractory partial epilepsy in subjects who are between 18 and 70 years of age, inclusive","other_id":"333369-EPY-2003","primary_purpose":"Treatment","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":79,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Age 18-70 years old,\r\n\r\n          2. Diagnosis of epilepsy for at least 1 year,\r\n\r\n          3. Presenting, on average, at least 3 partial onset seizures per month,\r\n\r\n          4. Currently treated with a stable dose (i.e., for at least 4 weeks) of no more than 3\r\n             anti-epileptic drugs (AEDs),\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Have experienced status epilepticus in the past 3 months,\r\n\r\n          2. Have any serious diseases,\r\n\r\n          3. History of major psychiatric disorders within the past 2 years.\r\n\r\n          4. Have received an experimental drug/device within the past 30 days\r\n\r\n          5. Are pregnant or breastfeeding.\r\n      ","sponsor":"SK Life Science, Inc.","sponsor_type":"Industry","conditions":"Refractory Epilepsy","interventions":[{"intervention_type":"Drug","name":"Drug: RWJ-333369"}],"outcomes":{}}
{"nct_id":"NCT00291928","start_date":"2005-02-28","phase":"Phase 2","enrollment":201,"brief_title":"HuMax-CD20 in Active Rheumatoid Arthritis, Phase I/II","official_title":"A Double-blind, Randomized, Placebo Controlled, Dose Escalation, Multi-centerphase I/II Trial of HuMax-CD20, a Fully Human Monoclonal Anti-CD20antibody, in Patients With Active Rheumatoid Arthritis Who Have Previously Failedone or More Disease Modifying Anti-rheumatic Drugs","primary_completion_date":"2007-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-09-30","last_update":"2012-11-12","description":"The purpose of this trial is primarily to investigate the safety profile of HuMax-CD20 in patients with active RA. Furthermore, the trial is designed to identify the dose levels to be used in future trials (based on evaluations of safety, pharmacokinetics and ACR and DAS responses).","other_id":"112657","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age  18 years\r\n\r\n          -  Active rheumatoid arthritis according to the American College of Rheumatology of at\r\n             least six months duration with six or more swollen and six or more tender joints (of\r\n             28 joints) and Erythrocyte Sedimentation Rate (ESR)  22 mm/h and/or C-Reactive\r\n             Protein (CRP)  10 mg/L (1 mg/dL).\r\n\r\n          -  Treatment failure to one or more DMARDs.\r\n\r\n          -  Treatment with methotrexate (7.5-25 mg/wk) for at least 12 weeks and at a stable dose\r\n             for at least 4 weeks prior to planned start of trial treatment.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Use of DMARDs other than methotrexate.\r\n\r\n          -  Current or previous (within four weeks of screening) participation in any other\r\n             clinical trial.\r\n\r\n          -  Previous exposure to other biological products within 4 weeks prior to planned start\r\n             of trial treatment, and/or exposure to anti-CD20 antibodies within two years before\r\n             screening for this trial.\r\n\r\n          -  Any use of cyclophosphamide, nitrogen mustard, chlorambucil or other alkylating agents\r\n             within five years before screening for this trial.\r\n\r\n          -  Active autoimmune disease (other than RA and RA-associated secondary diseases)\r\n             requiring immunosuppressive therapy.\r\n\r\n          -  Past or current malignancy, except for resected cervical carcinoma Stage 1B or less,\r\n             non-invasive basal cell and squamous cell skin carcinoma, malignant melanoma with a\r\n             complete response of a duration of > 10 years, or other cancer diagnoses with a\r\n             complete response of a duration of > 5 years.\r\n\r\n          -  Chronic or current infectious disease including known or suspected positive serology\r\n             for HIV, hepatitis B, or hepatitis C.\r\n\r\n          -  Clinically significant cardiac disease, or history of significant cerebrovascular\r\n             disease.\r\n\r\n          -  Significant concurrent, uncontrolled medical condition including, but not limited to:\r\n             renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological,\r\n             cerebral, or psychiatric disease.\r\n\r\n          -  Breast feeding women, women with a positive pregnancy test at screening, or women of\r\n             childbearing potential not willing to use adequate contraception during the trial.\r\n      ","sponsor":"GlaxoSmithKline","sponsor_type":"Industry","conditions":"Arthritis, Rheumatoid","interventions":[{"intervention_type":"Drug","name":"Drug: Part A","description":"Part A Cohort 1: HuMax-CD20 300 mg at Days 0 and 14 or Placebo at Days 0 and 14 Cohort 2: HuMax-CD20 700 mg at Days 0 and 14 or Placebo at Days 0 and 14 Cohort 3: HuMax-CD20 1000 mg at Days 0 and 14 or Placebo at Days 0 and 14"},{"intervention_type":"Drug","name":"Drug: Part B","description":"Part B Group 1: HuMax-CD20 300 mg at Days 0 and 14 Group 2: HuMax-CD20 700 mg at Days 0 and 14 Group 3: HuMax-CD20 1000 mg at Days 0 and 14 Group 4: Placebo at Days 0 and 14"}],"outcomes":[{"outcome_type":"primary","measure":"To evaluate the safety of HuMax-CD20 in patients with active rheumatoid arthritis","time_frame":"24 weeks"},{"outcome_type":"primary","measure":"To evaluate the efficacy of HuMax-CD20 in patients with active rheumatoid arthritis using the American College of Rheumatology (ACR) Response Assessment and Disease Activity Score (DAS) at 12 to 24 weeks after initiation of treatment","time_frame":"24 weeks"},{"outcome_type":"secondary","measure":"To evaluate the efficacy of HuMax-CD20 in patients with active rheumatoid arthritis by measuring the degree and duration of B-cell depletion","time_frame":"24 weeks"},{"outcome_type":"secondary","measure":"To determine the pharmacokinetic profile of HuMax-CD20 in patients with active rheumatoid arthritis","time_frame":"24 weeks"},{"outcome_type":"secondary","measure":"To determine host immune response, Human Anti Human Antibodies (HAHA), against HuMax-CD20","time_frame":"24 weeks"},{"outcome_type":"secondary","measure":"To evaluate the efficacy of HuMax-CD20 in patients with active rheumatoid arthritis using the American College of Rheumatology (ACR) Response Assessment and Disease Activity Score (DAS) at 36 & 48 weeks after initiation of treatment","time_frame":"48 weeks"},{"outcome_type":"secondary","measure":"To evaluate if Fc-receptor polymorphism influences the safety and efficacy of HuMax-CD20 in patients with active rheumatoid arthritis","time_frame":"24 weeks"}]}
{"nct_id":"NCT00612989","start_date":"2005-02-28","phase":"Phase 1","enrollment":42,"brief_title":"Ph I 5-day Temozolomide + O6-BG in Treatment of Pts w Recurrent / Progressive GBM","official_title":"Phase I Trial of a 5-day Regimen of Temodar Plus O6-Benzylguanine (O6-BG) in the Treatment of Patients With Recurrent / Progressive Glioblastoma Multiforme","primary_completion_date":"2007-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-07-31","last_update":"2014-07-16","description":"Primary objectives To determine maxi tolerated dose of Temodar in combo w O6-benzylguanine administered for 5 consecutive days in pts w progressive/recurrent GBM To characterize toxicity associated w Temodar in combo w O6-BG administered for 5 consecutive days in pts w progressive/recurrent GBM To determine Neulasta-supported MTD defined as the MTD of Temodar in combo with O6-BG administered for 5 days while receiving Neulasta once per treatment cycle between days 7 & 14 in pts w progressive/recurrent GBM To obtain preliminary response rates of Temodar in combo w O6-BG administered for 5 consecutive days in pts w progressive/recurrent GBM","other_id":"Pro00004058","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Pts have histologically proven supratentorial GBM\r\n\r\n          -  Pts have recurrent/progressive MG. If pt received stereotactic radiosurgery /\r\n             brachytherapy as part of their prior therapy, then histologic confirmation of\r\n             recurrence/metabolic imaging consistent w recurrent tumor is recommended but not\r\n             mandated\r\n\r\n          -  There must be measurable disease on contrast-enhanced magnetic resonance imaging study\r\n             / CT scan performed <2wks of study drug administration\r\n\r\n          -  Interval of >12 wks between completion of XRT & enrollment on protocol\r\n\r\n          -  Interval of >4 wks between prior chemo & enrollment on protocol unless there is\r\n             unequivocal evidence of tumor progression\r\n\r\n          -  Interval of >2 wks between prior surgical resection & enrollment on protocol unless\r\n             there is unequivocal evidence of tumor progression\r\n\r\n          -  Age >18 yrs\r\n\r\n          -  KPS >70 percent\r\n\r\n          -  Following baseline study will be required <1wk of study drug administration: serum\r\n             creatinine < 1.5 x ULN & Hematologic Status\r\n\r\n          -  Following baseline studies will be required <1wk of study drug administration:\r\n             absolute neutrophil count >2000 cells/microliter; platelet count >125,000\r\n             cells/microliter\r\n\r\n          -  Following baseline studies will be required <1 wk of study drug administration: serum\r\n             SGOT & total bilirubin < 2.5 x ULN\r\n\r\n          -  Signed informed consent, approved by IRB, will be obtained prior to initiating\r\n             treatment\r\n\r\n          -  Pts w Reproductive Potential: Pts must agree to practice effective birth control\r\n             measures while on study & for 2 months after completing therapy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnant/breast feeding women/ women/men w reproductive potential not practicing\r\n             adequate contraception. Therapy may be associated w potential toxicity to fetus/child\r\n             that exceeds mini risks necessary to meet health needs of mother\r\n\r\n          -  Prior treatment w O6-BG + Temozolomide in combo\r\n\r\n          -  Active infection requiring intravenous antibiotics\r\n\r\n          -  Known diagnosis of HIV infection\r\n\r\n          -  Pts w history of another primary malignancy that is currently clinically\r\n             significant/currently requires active intervention\r\n\r\n          -  Pts unwilling/unable to comply w protocol due to serious medical/psychiatric condition\r\n\r\n          -  Pts who have received investigational drugs <2 wks prior to start on study drug/have\r\n             not recovered from side effects of such therapy.\r\n      ","sponsor":"Duke University","sponsor_type":"Other","conditions":"Glioblastoma|Gliosarcoma","interventions":[{"intervention_type":"Drug","name":"Drug: Temodar and O6-Benzylguanine","description":"O6-BG 120mg/m2 administered intravenously over 1 hr followed by continuous infusion of O6-BG at 30 mg/m2/day for 5 consecutive days. Every 48 hrs repeat dose of 120 mg/m2 over 1 hr administered for total of 3 doses.\r\nTemodar administered orally, in fasting state within 60 minutes of end of 1st 1-hr infusion of O6-BG & then every 24 hrs during continuous infusion of O6-BG. Temodar administered on day 1 of treatment cycle & every 24 hrs thereafter for 5 days with treatment cycles repeated every 28 days.\r\nPts must fast for minimum of 1 hr prior to administration of each dose of Temodar & continue fasting 2 hrs after administration of each Temodar dose."}],"outcomes":[{"outcome_type":"primary","measure":"Dose limiting toxicity","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Progression-free survival","time_frame":"6 months"}]}
{"nct_id":"NCT00238485","start_date":"2005-01-31","phase":"Phase 3","enrollment":251,"brief_title":"An Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine 750-2000 mg/d in the Treatment of Manic Episodes of Bipolar I Disorder","official_title":"A 52-week, Open Label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine 750 - 2000 mg/d in the Treatment of Manic Episodes of Bipolar I Disorder.","primary_completion_date":"2007-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-07-31","last_update":"2017-03-28","description":"This extension study is designed to investigate the long-term safety and tolerability of licarbazepine 750-2000 mg/d over 52 weeks in patients who completed the 6-week double-blind study CLIC477D2302.","other_id":"CLIC477D2302E1","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  written informed consent provided prior to participation in the extension study.\r\n\r\n          -  successful completion of the study CLIC477D2302\r\n\r\n          -  willingness and ability to comply with all study requirements\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  premature discontinuation from the study CLIC477D2302\r\n\r\n          -  failure to comply with the study CLIC477D2302 protocol\r\n      ","sponsor":"Novartis","sponsor_type":"Industry","conditions":"Bipolar I Disorder","interventions":[{"intervention_type":"Drug","name":"Drug: Licarbazepine"}],"outcomes":[{"outcome_type":"primary","measure":"Safety and tolerability of licarbazepine with respect to adverse events, serious adverse events, changes in laboratory values, ECGs and vital signs."}]}
{"nct_id":"NCT00173966","start_date":"2005-01-31","enrollment":40,"brief_title":"A Case Control Study to Investigate the Possible Association Between Atrial Fibrillation and Endothelium Dysfunction by Using Flow-Mediated Vasodilation Method","study_type":"Observational","rec_status":"Unknown status","last_update":"2005-09-15","description":"Endothelial function is closely related to the hemostasis , vascular tone, and organ perfusion in cardiovascular system, and its dysfunction would cause overactivation of the coagulative system to induce thrombus formation. So we study the relationship between the endothelial function and atrial fibrillation.","other_id":"9361701155","observational_model":"Defined Population","time_perspective":"Other","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Lone AF patients and normal controls\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  DM, hypertension, hyperlipidemia, smoking, pregnancy,\r\n      ","sponsor":"National Taiwan University Hospital","sponsor_type":"Other","conditions":"Atrial Fibrillation|Endothelial Function","interventions":{},"outcomes":{}}
{"nct_id":"NCT00618176","start_date":"2005-01-31","phase":"Phase 4","enrollment":198,"brief_title":"Three Generic Nevirapine-Based Antiretroviral Treatments in Chinese Patients:Multicentric Observation Cohort","primary_completion_date":"2006-09-30","study_type":"Interventional","rec_status":"Completed","last_update":"2008-03-24","description":"The purpose of this study is to determine whether the three generic nevirapine-based antiretroviral regimens are effective in the treatment of Acquired immune deficiency syndrome .","other_id":"2004BA719A10","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18 years or older\r\n\r\n          -  the subjects were HIV-seropositive by standard serum enzyme-linked immunosorbent assay\r\n             (ELISA) tests and also by Western blot analysis\r\n\r\n          -  the subjects were antiretroviral drug-nave\r\n\r\n          -  a baseline CD4+ T-cell count from 100 to 350 cells/mm3 and a baseline plasma viral\r\n             load over 500copies/ml\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  pregnancy or breastfeeding\r\n\r\n          -  anticipated nonadherence\r\n\r\n          -  AIDS-defining illness within 2 weeks of entry\r\n\r\n          -  white blood cell count less than 2.0109/L, absolute neutrophil count less than\r\n             1.0109/L, hemoglobin level less than 90g/l, platelet count less than 0.751012/L\r\n\r\n          -  transaminase and alkaline phosphatase level more than 3 times the upper limit of the\r\n             normal range, bilirubin level more than 2.5times the upper limit of the normal range,\r\n             serum creatinine level more than 1.5 times the upper limit of the normal range\r\n      ","sponsor":"Peking Union Medical College","sponsor_type":"Other","conditions":"HIV Infections","interventions":[{"intervention_type":"Drug","name":"Drug: Zidovudine (AZT)+ Didanosine (ddI)+ Nevirapine (NVP)","description":"Zidovudine (AZT) 300mg bid Didanosine (ddI) 200mg bid (W>60Kg)125mg bid (W<60Kg) Nevirapine (NVP) 200mg bid"},{"intervention_type":"Drug","name":"Drug: Stavudine (d4T), Lamivudine (3TC), Nevirapine (NVP)","description":"Stavudine (d4T) 30mg bid (W>60Kg)20mg bid (W<60Kg) Lamivudine (3TC)300mg qd Nevirapine (NVP)200mg bid"},{"intervention_type":"Drug","name":"Drug: Zidovudine (AZT), Lamivudine (3TC), Nevirapine (NVP)","description":"Zidovudine (AZT) 300mg bid Lamivudine (3TC) 300mg qd Nevirapine (NVP) 200mg bid"}],"outcomes":{}}
{"nct_id":"NCT01497912","start_date":"2005-01-31","phase":"Phase 4","enrollment":20,"brief_title":"Treatment Effects of Atorvastatin on Hemostasis and Skin Microcirculation in Patients With Type 1 Diabetes","primary_completion_date":"2009-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-01-31","last_update":"2011-12-23","description":"Patients with type 1 diabetes are at increased risk of vascular complications both in the micro- and macrocirculation. Hyperglycemia plays a major role in the development of these vascular complications, but other factors such increased platelet adhesion and aggregation, elevated levels of plasma fibrinogen, altered fibrin network structure, increased thrombin generation, dyslipidemia and endothelial dysfunction may contribute. Lipid-lowering therapy with statins is effective in prevention of cardiovascular events in individuals at increased risk. Statins seem to exert beneficial effects on hemostasis and vasculature that are independent of their lipid-lowering properties. The aim of the present study was to investigated the effects of intensive LDL-cholesterol-lowering therapy with atorvastatin on fibrin network permeability (primary variable) and other aspects of hemostasis in patients with type 1 diabetes and dyslipidemia. Furthermore, the effects of atorvastatin therapy on skin microvascular function was also investigated.","other_id":"Dnr 04-681/2","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":30,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  type 1 diabetes\r\n\r\n          -  level of plasma LDL-cholesterol >2.5mmol/L and/or total cholesterol >4.5mmol/L\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of macrovascular events\r\n      ","sponsor":"Karolinska Institutet","sponsor_type":"Other","conditions":"Type 1 Diabetes Mellitus|Dyslipidemia","interventions":[{"intervention_type":"Drug","name":"Drug: Atorvastatin","description":"Atorvastatin 80mg once daily for 8 weeks"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo tablet once daily for 8 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Fibrin network permeability","time_frame":"8 weeks"},{"outcome_type":"secondary","measure":"platelet and endothelial microparticles","time_frame":"8 weeks"},{"outcome_type":"secondary","measure":"skin microvascular reactivity","time_frame":"8 weeks"}]}
{"nct_id":"NCT00214929","start_date":"2004-12-31","phase":"Phase 4","brief_title":"Home Treatment of Pulmonary Embolism","official_title":"Cooperative Investigation Plan for Home Treatment of Pulmonary Embolism","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2005-08-31","last_update":"2005-12-09","description":"The best management in selected patients of pulmonary Embolism (PE) should be at home. The efficacy and safety treatments at home versus at hospital should be similar and quality of life should be better. Our purpose is to demostrate that Low weight molecular heparin (LWMH) at home for PE is at least as effective and safe at home as at hospital","other_id":"PIO30192","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  The consecutive outpatients subjects diagnosed of PE at 10 different Spanish\r\n             hospitals.\r\n\r\n          -  A score of 2 or under in our prediction rule (risk score for short-term)\r\n\r\n          -  Signed written Informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  A score over 2 in our prediction rule\r\n\r\n          -  Patients with a PE requiring thrombolysis or surgical thrombectomy\r\n\r\n          -  Patients with right ventricular dyskinesia in echocardiography at 48 hours from\r\n             heparin therapy. (It is not necessary echocardiography for the model of discharge at 5\r\n             days)\r\n\r\n          -  Troponin level over 0,1 g/L\r\n\r\n          -  Patiens requiring oxygen therapy or under 93% in oxygen saturation level.\r\n\r\n          -  Patients requiring intravenous analgesic therapy\r\n\r\n          -  Patients with some medical or surgical conditions requiring to stay at hospital\r\n\r\n          -  Patients with advanced chronic cardiovascular diseases (dyspnea III-IV NYHA)\r\n\r\n          -  Patients with advanced chronic respiratory diseases (several COPD criteria of GOLD\r\n             with FEV1< 50%)\r\n\r\n          -  Documented congenital or acquired bleeding tendency /disorder (s)\r\n\r\n          -  Documented current ulceration or angiodysplastic gastrointestinal disease\r\n\r\n          -  Hemorrhagic stroke or recent (< 3 months prior to randomization) brain, spinal, or\r\n             ophthalmological surgery.\r\n\r\n          -  Recent surgery < 3 days\r\n\r\n          -  Pregnancy\r\n\r\n          -  Several Obesity (CMI over 30)\r\n\r\n          -  Patients could not complete the treatment at home.\r\n\r\n          -  Exclusion criteria related to study procedures\r\n\r\n          -  Life expectancy < 3 months\r\n      ","sponsor":"Carlos III Health Institute","sponsor_type":"Other","conditions":"Pulmonary Embolism","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: treatment at home"}],"outcomes":[{"outcome_type":"primary","measure":"-Thromboembolic recurrences"},{"outcome_type":"primary","measure":"-Bleeding Complications"},{"outcome_type":"primary","measure":"-Deaths"},{"outcome_type":"secondary","measure":"-Quality of life"}]}
{"nct_id":"NCT00189501","start_date":"2004-12-31","enrollment":1000,"brief_title":"A Multi-Center, Observational Registry of Subjects With Secondary Hyperparathyroidism (HPT) and Chronic Kidney Disease (CKD)","official_title":"A Multi-Center, Observational Registry of Subjects With Secondary Hyperparathyroidism (HPT) and Chronic Kidney Disease (CKD)","study_type":"Observational","rec_status":"Completed","last_update":"2007-12-28","description":"Objectives include description of current practices; assessment over time of K/DOQI goals, clinical outcomes, health resource utilization(HRU) and patient reported outcomes (PRO) and the impact of Sensipar on these parameters","other_id":"20040159","time_perspective":"Prospective","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  3 month history of Stage 4 or Stage 5 CKD\r\n\r\n          -  A PTH value within 3 months of enrollment\r\n\r\n          -  If relevant, completion of Sensipar study prior to enrolling in Registry Exclusion\r\n             Criteria:\r\n\r\n          -  Females who are pregnant or breast feeding\r\n      ","sponsor":"Amgen","sponsor_type":"Industry","conditions":"Nephrology","interventions":[{"intervention_type":"Drug","name":"Drug: Sensipar"}],"outcomes":{}}
{"nct_id":"NCT00104416","start_date":"2004-12-31","phase":"Phase 3","enrollment":153,"brief_title":"Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Primary Generalized Tonic-Clonic Seizures (PGTC) Seizures","official_title":"A Multicenter, Double-blind, Randomized, Parallel-group Evaluation of LAMICTAL Extended-Release Adjunctive Therapy in Patients With Primary Generalized Tonic-Clonic Seizures","primary_completion_date":"2008-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-07-31","last_update":"2017-01-02","description":"This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine) extended-release with placebo in the treatment of Primary Generalized Tonic-Clonic (PGTC) seizures. LAMICTAL extended-release is an investigational drug. Placebo tablets look like LAMICTAL extended-release tablets but do not contain active medication. In this study, LAMICTAL extended-release or placebo tablets will be added to current seizure treatments.","other_id":"LAM100036","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":13,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Is 13 years of age (male or female).\r\n\r\n          -  Has a confident diagnosis of epilepsy with PGTC seizures for more than 24 weeks prior\r\n             to the Baseline Phase.\r\n\r\n          -  Has electroencephalogram (EEG) evidence of either spike-and-wave discharges consistent\r\n             with PGTC, or at least 2 EEGs with no indication of focal abnormalities. The EEG may\r\n             be historical or prospective. Investigators may use a historical EEG as long as there\r\n             is appropriate documentation.\r\n\r\n          -  Has a documented history of PGTC seizures with or without other generalized seizure\r\n             type(s) with no focal onset, and at least 1 PGTC seizure during the eight consecutive\r\n             weeks (i.e., 56 consecutive days) prior to starting the 8-week Baseline Phase.\r\n\r\n          -  Has at least 3 PGTC seizures occurring anytime during an 8-week (i.e., 56 days)\r\n             prospective Baseline Phase.\r\n\r\n               -  NOTE: When a historical baseline is used, the same time period cannot count for\r\n                  documentation of inclusion criteria 4 and 5. Additionally, innumerable seizure\r\n                  activity will not count towards the number of seizures required for\r\n                  randomization.\r\n\r\n               -  NOTE: With authorization from GSK, a maximum of four weeks (i.e., 28 days) of\r\n                  historical seizure data may replace up to four weeks (i.e., 28 days) of the\r\n                  prospective Baseline Phase for subjects providing reliable documentation of the\r\n                  following:\r\n\r\n                    1. complete daily seizure diary that includes the number of seizures\r\n                       experienced each day along with the exact classification of each seizure\r\n                       type for consecutive days prior to the prospective Baseline Phase\r\n\r\n                    2. stability of prescribed dosages of background antiepileptic drugs (AEDs)\r\n\r\n                    3. compliance with background AEDs.\r\n\r\n               -  All subjects permitted to use historical seizure data must complete a minimum of\r\n                  four weeks (i.e., 28 days) of the prospective Baseline Phase. The historical\r\n                  Baseline Phase and the prospective Baseline Phase must equal 56 consecutive days.\r\n\r\n          -  Is currently treated with a stable regimen of one or two AED(s) for at least four\r\n             weeks prior to starting the Baseline Phase (historical or prospective).\r\n\r\n               -  NOTE: Benzodiazepines used chronically will be considered to be concurrent AEDs.\r\n\r\n               -  NOTE: Subjects with surgically implanted vagal nerve stimulators (VNS) will be\r\n                  allowed to enter the study provided that all of the following conditions are met:\r\n\r\n                    1. VNS has been in place for at least 24 weeks prior to the Baseline Phase.\r\n\r\n                    2. The settings must remain the same for at least 28 days prior to the Baseline\r\n                       Phase.\r\n\r\n                    3. The settings must remain the same during the Baseline, Escalation,\r\n                       Maintenance and Transition Phases.\r\n\r\n                    4. The battery is expected to last for the duration of the study.\r\n\r\n                    5. VNS is counted as a \"concurrent AED.\"\r\n\r\n          -  Is able and willing to maintain an accurate and complete daily written seizure diary,\r\n             or has a parent/caregiver who is able and willing to maintain an accurate and complete\r\n             daily written seizure diary for the entire duration of the study.\r\n\r\n          -  Is able to comply with dosing of study drugs, background AEDs and all study\r\n             procedures.\r\n\r\n          -  Has given written informed consent, or has a parent/legally authorized representative\r\n             who has given written informed consent, prior to the performance of any study\r\n             assessments.\r\n\r\n          -  If female, and of childbearing potential, must be using an acceptable form of birth\r\n             control, to include one of the following:\r\n\r\n               1. Complete abstinence from intercourse for two weeks before exposure to the study\r\n                  drug, throughout the clinical trial, and for a period after the trial to account\r\n                  for elimination of the drug (a minimum of 3 weeks).\r\n\r\n               2. Consistent and correct use of one of the following methods of birth control:\r\n\r\n                    -  Male partner who is sterile prior to the female subject's entry into the\r\n                       study and is the sole sexual partner for that female subject\r\n\r\n                    -  Implants of levonorgestrel\r\n\r\n                    -  Injectable progestogen\r\n\r\n                    -  Oral contraceptive (either combined, with at least 50mcg estrogen for women\r\n                       on enzyme-induced AEDs, or progestogen only)\r\n\r\n                    -  Any intrauterine device (IUD) with a documented failure rate of less than 1%\r\n                       per year\r\n\r\n                    -  Double barrier method consisting of spermicide plus a mechanical barrier\r\n                       (e.g., spermicide plus a male condom or a female diaphragm).\r\n\r\n                    -  NOTE: Women who have had a hysterectomy, tubal ligation, or are\r\n                       post-menopausal are considered to be of non-childbearing potential.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Has a history of partial seizures or interictal expression of partial seizures as\r\n             evidenced by EEG NOTE: EEG may be historical or prospective.\r\n\r\n          -  Has had status epilepticus within the 24 weeks prior to, or during, the Baseline\r\n             Phase.\r\n\r\n          -  Is taking three or more background AEDs chronically.\r\n\r\n          -  Has Lennox-Gastaut syndrome.\r\n\r\n          -  Is currently using or has previously used lamotrigine.\r\n\r\n          -  Is currently taking felbamate.\r\n\r\n          -  Is abusing alcohol and/or other substance(s).\r\n\r\n          -  Has taken an investigational drug within the previous 30 days or plans to take an\r\n             investigational drug anytime during the study.\r\n\r\n          -  Is receiving chronic treatment with any medication that could influence seizure\r\n             control. NOTE: Use of benzodiazepines is allowed.\r\n\r\n          -  Is currently following the ketogenic diet.\r\n\r\n          -  Is planning surgery to control seizures during the study.\r\n\r\n          -  Is suffering from acute or progressive neurological disease, severe psychiatric\r\n             disease, or severe mental abnormality that are likely to interfere with the objectives\r\n             of the study.\r\n\r\n          -  Has any clinically significant cardiac, renal, hepatic condition, or a condition that\r\n             affects the absorption, distribution, metabolism or excretion of drugs.\r\n\r\n          -  Is pregnant, breastfeeding, or planning to become pregnant during the study or within\r\n             the three weeks after the last dose of study drug.\r\n      ","sponsor":"GlaxoSmithKline","sponsor_type":"Industry","conditions":"Epilepsy, Tonic-Clonic","interventions":[{"intervention_type":"Drug","name":"Drug: lamotrigine (LAMICTAL) extended-release","description":"Primary experimental dosage form"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo control"}],"outcomes":[{"outcome_type":"primary","measure":"Percent Change From Baseline in Weekly Primary Generalized Tonic-clonic (PGTC) Seizure Frequency During the Entire Double-Blind Treatment Phase","time_frame":"Baseline through end of Double-Blind Treatment Phase (up to Week 19)","description":"Percent change from baseline is calculated as the number of seizures by week during the Double-Blind Treatment Phase (Treatment Week 1 up to Week 19) compared to the number of seizures per week during the Baseline Phase (Baseline Week 1 up to Week 8). A positive number equals a reduction in seizure frequency. PGTC seizures are more commonly known as gran mal seizures."},{"outcome_type":"secondary","measure":"Number of Participants With >=25%, >=50%, >=75%, or 100% Reduction in PGTC Seizure Frequency During the Entire Double-Blind (DB)Treatment Phase (TP), the Escalation Phase, the Maintenance Phase, and the Last 8 Weeks of the Maintenance Phase","time_frame":"Entire DB Treatment Phase (Treatment Week 1 up to Week 19), Escalation Phase (Treatment Week 1 up to Week 7), Maintenance Phase (Treatment Week 8 up to Week 19), and the last 8 weeks of the Maintenance Phase (Treatment Week 12 up to Week 19)","description":"Change in seizure frequency was calculated as the average seizure frequency during each of the following: the Entire DB Treatment Phase (Treatment Week 1 up to Week 19); the Escalation Phase (Treatment Week 1 up to Week 7); the Maintenance Phase (Treatment Week 8 up to Week 19); and the last 8 weeks of the Maintenance Phase (Treatment Week 12 up to Week 19), minus the seizure frequency at Baseline."},{"outcome_type":"secondary","measure":"Percent Change From Baseline in PGTC Seizure Frequency During the Escalation Phase, the Maintenance Phase, and During the Last 8 Weeks of the Maintenance Phase of the Double-Blind Treatment Phase","time_frame":"Escalation Phase (Treatment Week 1 up to Week 7), Maintenance Phase (Treatment Week 8 up to Week 19), and the last 8 weeks of the Maintenance Phase (Week 12 up to Week 19)","description":"Percent change from baseline is calculated as the number of seizures by week during the Escalation Phase (Treatment Week 1 up to Week 7), the Maintenance Phase (Treatment Week 8 up to Week 19), and during the last 8 weeks of the Maintenance Phase (Treatment Week 12 up to Week 19) compared to the number of seizures per week during the Baseline Phase (Baseline Week 1 up to Week 8). A positive number equals a reduction in seizure frequency."},{"outcome_type":"secondary","measure":"Number of Participants With the Indicated Time to >=50% Reduction in Seizure Frequency in the Double-Blind Treatment Phase","time_frame":"Baseline through end of Double-Blind Treatment Phase (up to Week 19)","description":"50% reduction in seizure frequency is defined as the time at which a participant first achieved and maintained a >=50% reduction in seizure frequency following exposure to at least 1 week of study drug."},{"outcome_type":"secondary","measure":"Change From Baseline in Body Weight at Week 19 of the Double-Blind Treatment Phase","time_frame":"Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)","description":"Change from baseline in body weight is calculated as the Week 19 (or last on-study measurement in Double-Blind Treatment Phase) value minus the Baseline value."},{"outcome_type":"secondary","measure":"Number of Participants With Improved Clinical Status on the Investigator's Global Assessment in the Double-Blind Treatment Phase","time_frame":"Week 19 (or last on-study assessment in Double-Blind Treatment Phase)","description":"The investigators rated the participants' overall clinical status based on 7 clinical factors and an overall factor: seizure frequency, duration, and intensity; adverse experiences; social, intellectual, and motor functioning. Using a 7-point scale (marked deterioration [1], moderate deterioration [2], mild deterioration [3], no change [4], mild improvement [5], moderate improvement [6], or marked improvement [7]), the investigators assessed the participants' status compared to their condition prior to initiating study medication."},{"outcome_type":"secondary","measure":"Number of Participants With Improved Satisfaction With Seizure Control on the Subject Satisfaction Questionnaire in the Double-Blind Treatment Phase","time_frame":"Week 19 (or last on-study assessment in Double-Blind Treatment Phase)","description":"Participants were asked to rate their satisfaction with their seizure control compared to their seizure control prior to initiating study drug on a 7 point scale: marked deterioration (1), moderate deterioration (2), mild deterioration (3), no change (4), mild improvement (5), moderate improvement (6), or marked improvement (7)."},{"outcome_type":"secondary","measure":"Percent Change From Baseline in Weekly PGTC Seizure Frequency During the Entire Continuation Phase (CP), the Transition Phase, the Open-Label Phase, and the Last 8 Weeks of the Open-Label Phase","time_frame":"Entire CP (CP Week 1 up to Week 52), the Transition Phase (CP Week 1 up to Week 7), the Open-Label Phase (CP Week 8 up to Week 52), and the last 8 weeks of the Open-Label Phase (CP Week 45 up to Week 52)","description":"Percent change from baseline is calculated as the number of seizures by week during the entire CP (CP Week 1 up to Week 52), the Transition Phase (CP Week 1 up to Week 7), the Open-Label Phase (CP Week 8 up to Week 52), and the last 8 weeks of the Open-Label Phase (CP Week 45 up to Week 52) minus the number of seizures per week during the Baseline Phase (Baseline Week 1 through Week 8). A positive number equals a reduction in seizure frequency."},{"outcome_type":"secondary","measure":"Number of Participants With >=25%, >=50%, >=75%, or 100% Reduction or >=50% Increase From Baseline in Weekly PGTC Seizure Frequency for the Entire Continuation Phase, the Transition Phase, the Open-Label (OL) Phase, and the Last 8 Weeks of the OL Phase.","time_frame":"Entire CP (CP Week 1 up to Week 52), the Transition Phase (CP Week 1 up to Week 7), the Open-Label Phase (CP Week 8 up to Week 52), and the last 8 weeks of the Open-Label Phase (CP Week 45 up to Week 52)","description":"Change in seizure frequency was calculated as the average seizure frequency during each of the following: the Entire CP (CP Week 1 up to Week 52); the Transition Phase (CP Week 1 up to Week 7); the Open-Label (OL) Phase (CP Week 8 up to Week 52); and the last 8 weeks of the Open Label Phase (CP Week 45 up to Week 52) minus the seizure frequency at Baseline. W, Week."},{"outcome_type":"secondary","measure":"Mean Change From Baseline in the Profile of Mood State (POMS) Mood Disturbance Total Score at Week 19 of the Double-Blind Treatment Phase","time_frame":"Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)","description":"The POMS is a self-administered 65-item questionnaire that evaluates the participants' perception of their mood state in 6 areas: tension-anxiety, depression-dejection, anger-hostility, vigor-activity, fatigue-inertia, and confusion-bewilderment. Items are rated on a 5-point Likert scale from 0 (not at all) to 4 (extremely), with higher scores indicating a more negative mood state. A total score (from 0 to 24) is obtained by summing the scores of the six domains."},{"outcome_type":"secondary","measure":"Mean Change From Baseline in the Center for Epidemiological Studies-Depression Scale (CES-D) Total Score at Week 19 of the Double-Blind Treatment Phase","time_frame":"Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)","description":"The 20-item CES-D questionnaire is self-administered and asks respondents to report the frequency to which the 20 events were experienced over the past week. A 4-point Likert scale is used and ranges from rarely or none of the time (0) to most or all of the time (3). The total score, a sum across the 20 items (ranging from 0 to 60), determines the extent to which a participant may be experiencing depression. Higher scores indicate a higher severity of depression."},{"outcome_type":"secondary","measure":"Mean Change From Baseline in the Neurological Disorders Depression Inventory-Epilepsy (NDDI-E) 6-Item Total Score at Week 19 of the Double-Blind Treatment Phase","time_frame":"Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)","description":"The NDDI-E is a self-reported questionnaire composed of 46 brief phrases/words to identify mood disorders across the spectrum of depression. It was developed to capture depressive moods that are co-morbid with the disease of epilepsy or its treatment as well as to measure the depressive state of the participant. All phrases are measured on a 4-point Likert scale of Never (1) to Always/often (4) and refer to the participants' mood over the past week. Scoring is comprised of a total mood score calculated by summing the scores of 6 specific items (from 6=never to 24=always or often)."},{"outcome_type":"secondary","measure":"Mean Change From Baseline in the Quality of Life in Epilepsy-31-P (QOLIE-31P) Overall Score at Week 19 of the Double-Blind Treatment Phase","time_frame":"Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)","description":"The QOLIE-31 is a 31-item questionnaire that evaluates the participants' perception of his or her quality of life in 7 domains: seizure worry, emotional well being, energy/fatigue, cognitive functioning, medication effects, social functioning, and overall quality of life. Each domain (with scores ranging from 0 to 100) is summed and divided by the total number of questions that were answered. The overall score is derived by weighting and then summing up the seven domain scores."},{"outcome_type":"secondary","measure":"Mean Change From Baseline in the Adverse Experience Profile (AEP) Total Score at Week 19 of the Double-Blind Treatment Phase","time_frame":"Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)","description":"The AEP is a list of 19 items covering many possible side effects attributable to drug treatment. The participants respond by assessing how much each event has been a problem for them over the past 4 weeks (1=Never a Problem to 4=Always a Problem). Each individual item can be examined; an overall adverse events score is calculated as the sum of the scores across the 19 items. The AEP total score ranges from 19 to 76, with a higher score indicating a higher degree of adverse event severity."},{"outcome_type":"secondary","measure":"Mean Change From Baseline in the Seizure Severity Questionnaire (SSQ) Global Bother Score at Week 19 Double-Blind Treatment Phase","time_frame":"Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)","description":"The SSQ is a self-reported instrument developed to assess the severity of seizures and seizure symptoms. The scale consists of 10 major clinical features/symptoms of seizures that the participants rate on a 7-point Likert scale (ranging from very mild/helpful/no bother at all [1] to very severe/no help/bothersome [7]). The Global Bother Domain is the primary score used for the analysis of the SSQ and has scores ranging from 1 to 7."},{"outcome_type":"secondary","measure":"Mean Change From Baseline in the Epworth Sleepiness Scale (ESS) 8-Item Total Score at Week 19 of the Double-Blind Treatment Phase","time_frame":"Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)","description":"The ESS is an 8-item, self-administered questionnaire that measures excessive daytime sleepiness in adults. The instrument captures information on the extent to which the participant would be likely, or not, to fall asleep in certain situations. The stimulus question is: How likely are you to doze off or fall asleep in the following situations, in contrast to feeling just tired? Questions are answered on a 4-point scale (would never doze [0] to high chance of dozing [3]). The total score ranges from 0 to 24, where a higher score indicates a higher chance of dozing."},{"outcome_type":"secondary","measure":"Serum Concentrations and Population (POP) Pharmacokinetic Parameters for Lamotrigine","time_frame":"Blood samples drawn at Treatment Weeks 11, 15, and 19 (or last on-study measurement in Double-Blind Treatment Phase)","description":"Serum samples for participants on lamotrigine were analyzed with a validated analytical method based on solid phase extraction of serum followed by High-Performance Liquid Chromatography (HPLC) Mass Spectrometry (MS)/MS analysis. The lower limit of quantification (LLQ) for serum lamotrigine was 4 nanograms (ng)/milliliter (mL), using a 50 microliter (µL) aliquot of human serum with a higher limit of quantification (HLQ) of 4,000 ng/mL. PK data cannot be reported, as PK data from several different studies have been combined into one POP/PK analysis and cannot be separated by study."}]}
{"nct_id":"NCT00456027","start_date":"2004-12-31","phase":"Phase 2","enrollment":160,"brief_title":"Safety of Diamyd in Patients With LADA (Latent Autoimmune Diabetes in Adult)","official_title":"A Placebo-Controlled Study to Investigate the Impact of Diamyd on the Diabetes Status of Patients With LADA (Latent Autoimmune Diabetes in Adult)","primary_completion_date":"2008-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-04-30","last_update":"2011-06-10","description":"This is a study to investigate the safety of 20ug Diamyd (rhGAD65 formulated in Alhydrogel), administered subcutaneously four weeks apart in patients with Latent Autoimmune Diabetes in Adult (LADA).","other_id":"D/P2/04/2","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":30,"maximum_age":70,"population":"","criteria":"\n        Key Inclusion Criteria:\r\n\r\n          -  Male and female patients between 30-70 years of age diagnosed with type 2 diabetes\r\n             within 5 years\r\n\r\n          -  Presence of GAD65 antibodies\r\n\r\n          -  Detectable C-peptide level\r\n\r\n          -  Patients requiring treatment with diet and/or oral hypoglycaemic agents (OHA)\r\n\r\n          -  Written informed Consent\r\n\r\n        Key Exclusion Criteria:\r\n\r\n          -  Treatment with insulin\r\n\r\n          -  Intolerance to OHA\r\n\r\n          -  Secondary diabetes mellitus\r\n\r\n          -  History of certain diseases or conditions (e.g. anaemia, epilepsy, head trauma,\r\n             neurological disease, alcohol or drug abuse, HIV, hepatitis)\r\n\r\n          -  Treatment with any vaccine within one month prior to first Diamyd dose or planned\r\n             treatment with vaccine up to 2 months after the second Diamyd dose\r\n\r\n          -  Participation in other clinical trials with a new chemical entity within the previous\r\n             3 months\r\n\r\n          -  Pregnancy (or planned pregnancy within one year after 2nd administration)\r\n\r\n          -  Presence of associated serious disease or condition which in the opinion of the\r\n             investigator makes the patient non-eligible for the study\r\n\r\n          -  Significant illness other than diabetes within 2 weeks prior to first dosing\r\n\r\n          -  Unwillingness to comply with the provisions of the protocol\r\n\r\n          -  Clinically significant history of acute reaction to drugs in the past\r\n\r\n          -  Treatment with immunosuppressants\r\n      ","sponsor":"Diamyd Therapeutics AB","sponsor_type":"Industry","conditions":"Latent Autoimmune Diabetes in Adult (LADA)","interventions":[{"intervention_type":"Drug","name":"Drug: rhGAD65 formulated in Alhydrogel (Diamyd)","description":"20 micrograms of rhGAD65 formulated in Alhydrogel administered subcutaneously twice 4 weeks apart"}],"outcomes":[{"outcome_type":"primary","measure":"The development over time of safety variables, i.e. injection site discomfort, vital signs, laboratory values and AEs/SAEs as well as development of diabetes status, i.e. HbA1c, C-peptide, blood glucose and insulin requirement.","time_frame":"30 months"}]}
{"nct_id":"NCT00750477","start_date":"2004-12-31","phase":"N/A","enrollment":67,"brief_title":"Efficacy & Safety Study Evaluating Natural Eggshell Membrane (NEM) in the Treatment of Osteoarthritis","official_title":"A Multi-Center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effectiveness and Safety of Natural Eggshell Membrane (NEM) in the Treatment of Pain & Stiffness Associated With Moderate Osteoarthritis of the Knee","primary_completion_date":"2006-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2006-05-31","last_update":"2016-02-15","description":"The purpose of this study is to evaluate the effectiveness of Natural Eggshell Membrane (NEM) for the relief of pain and stiffness associated with moderate osteoarthritis of the knee and to compare the effectiveness of NEM to placebo.","other_id":"CLN # C0504","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  known symptomatic osteoarthritis of the knee\r\n\r\n          -  patients must have been diagnosed with functional Grades I-III of osteoarthritis\r\n             according to the modified criteria of the American College of Rheumatology\r\n\r\n          -  must also have had persistent knee pain associated with osteoarthritis with a baseline\r\n             score of at least 30 mm on the Patient's Assessment of Arthritis Pain - Visual Analog\r\n             Scale\r\n\r\n          -  required to suspend all current pain relief medications. Subjects that were currently\r\n             taking analgesic medications were eligible to participate in the study following a 14\r\n             day washout period for NSAIDs, a 7 day washout for narcotics, and a 90 day washout for\r\n             injected steroids. Subjects currently taking glucosamine, chondroitin sulfate or MSM\r\n             were only eligible after a 3-month washout period.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  are currently receiving remission-inducing drugs such as methotrexate or\r\n             immunosuppressive medications or had received them within the past 3 months\r\n\r\n          -  had a confounding inflammatory disease or condition (rheumatoid arthritis, gout,\r\n             pseudo gout, Paget's disease, chronic pain syndrome, etc.) that would interfere with\r\n             assessment of pain associated with the index knee\r\n\r\n          -  body weight 250 pounds or greater\r\n\r\n          -  having a known allergy to eggs or egg products\r\n\r\n          -  pregnant or breastfeeding women\r\n\r\n          -  Subjects previously enrolled in a study to evaluate pain relief within the past 6\r\n             months or currently involved in any other research study involving an investigational\r\n             product (drug, device, or biologic) or a new application of an approved product,\r\n             within 30 days of screening\r\n      ","sponsor":"ESM Technologies, LLC","sponsor_type":"Industry","conditions":"Osteoarthritis","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: NEM","description":"see Treatment Arms"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Placebo","description":"Placebo comparator containing inactives"}],"outcomes":[{"outcome_type":"primary","measure":"The primary endpoint of the study was measurement of the effectiveness of NEM® in relieving pain, stiffness, and discomfort associated with moderate OA of the knee and to compare its effectiveness to placebo.","time_frame":"10, 30, & 60 Days"},{"outcome_type":"secondary","measure":"Secondary objectives of the study were to evaluate tolerability and any adverse reactions associated with supplementation with NEM®.","time_frame":"10, 30, & 60 Days"}]}
{"nct_id":"NCT00494988","start_date":"2004-12-31","phase":"Phase 4","enrollment":33,"brief_title":"Self-control Trial to Evaluate the Remission Rate in Newly Diagnosed Type 2 Diabetes Patients After Treatment With Insulin Aspart","official_title":"Self-control Trial to Evaluate the Remission Rate and Safety in Newly Diagnosed Type 2 Diabetes Patients After Short-term Intensive Insulin Aspart and Insulin NPH Treatment","primary_completion_date":"2006-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2006-04-30","last_update":"2016-03-04","description":"This trial is conducted in Asia. The aim of this trial is evaluate the remission rate in newly diagnosed subjects with type 2 diabetes after short-term intensive treatment with insulin aspart and insulin NPH.","other_id":"ANA-1635","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Type 2 diabetes newly diagnosed within 6-12 months\r\n\r\n          -  FBG: 11.1-17.0 mmol/L\r\n\r\n          -  Body mass index (BMI) larger than 25.0 kg/m2\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Known or suspected allergy to trial product(s) or related products\r\n\r\n          -  Recurrent major hypoglycaemia as judged by the Investigator\r\n      ","sponsor":"Novo Nordisk A/S","sponsor_type":"Industry","conditions":"Diabetes|Diabetes Mellitus, Type 2","interventions":[{"intervention_type":"Drug","name":"Drug: insulin NPH"},{"intervention_type":"Drug","name":"Drug: insulin aspart"}],"outcomes":[{"outcome_type":"primary","measure":"Remission rate","time_frame":"after 24 weeks"},{"outcome_type":"secondary","measure":"blood glucose profiles"},{"outcome_type":"secondary","measure":"HbA1c"}]}
{"nct_id":"NCT00200655","start_date":"2004-12-31","phase":"Phase 3","enrollment":40,"brief_title":"Safety and Efficacy of Pravastatin in Relapsing-remitting Multiple Sclerosis","official_title":"Safety and Efficacy of Pravastatin in Relapsing-remitting MS: a Double Blind Placebo Controlled Study","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-11-30","last_update":"2016-04-28","description":"Therapeutic strategies for multiple sclerosis (MS) are essentially based on the use of immunomodulatory agents such as interferon b and glatirmere acetate, but their efficacy is quite limited, they are not well tolerated and they have a very high cost. Recent works showed an immunomodulatory effects of HMG-CoA reductase inhibitors (the so-called \"statins\"). In experimental allergic encephalopathy, a murine model of MS, statins inhibit the onset and progression of the disease through a shift from Th1 towards Th2 cytokine production. Other in vitro studies suggest the ability of statins to inhibit the lymphocyte migration through the blood brain barrier. Furthermore, in an open labeled human study in MS, statin regimen was associated with a decreased lesional activity assessed by MRI. Statins are well tolerated drugs, used for many years, with a low cost and with a putative efficacy in MS. The investigators suggest to test the pravastatin safety and efficacy on MRI criteria in a double-blind, placebo-controlled study in 40 patients with a relapsing-remitting MS.","other_id":"BRD/03/10-I-1","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Relapsing remitting MS with diagnosis defined by the McDonald criteria (McDonald et\r\n             al., 2001) with no current disease modifying therapy (interferon, copaxone or\r\n             immunosuppressant drugs) since at least 3 months and an EDSS score < 5.\r\n\r\n          -  At least one gadolinium positive lesion on the MRI of the selection phase is needed.\r\n\r\n          -  No current statin therapy.\r\n\r\n          -  Normal renal and hepatic biological tests.\r\n\r\n          -  No current pregnancy\r\n      ","sponsor":"Nantes University Hospital","sponsor_type":"Other","conditions":"Relapsing-remitting Multiple Sclerosis","interventions":[{"intervention_type":"Drug","name":"Drug: Pravastatin"},{"intervention_type":"Drug","name":"Drug: Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"Number of gadolinium positive lesions at month 6 in each group.","time_frame":"at month 6 in each group"},{"outcome_type":"secondary","measure":"Cumulated number of gadolinium positive lesions in each group after 6 months of follow-up","time_frame":"after 6 months of follow-up"},{"outcome_type":"secondary","measure":"Number of new T2 lesions"}]}
{"nct_id":"NCT00102648","start_date":"2004-12-21","phase":"Phase 1","enrollment":35,"brief_title":"Lonafarnib and Temozolomide in Treating Patients With Glioblastoma Multiforme That Is Recurrent or Did Not Respond to Previous Treatment With Temozolomide","official_title":"Phase I/Ib Study of Sarasar and Temodar in Patients With Recurrent or Temodar-Refractory Glioblastoma Multiforme","primary_completion_date":"2022-12-01","study_type":"Interventional","rec_status":"Active, not recruiting","completion_date":"2022-12-01","last_update":"2020-06-16","description":"This phase I trial studies the side effects and best dose of lonafarnib when given together with temozolomide and to see how well they work in treating patients with glioblastoma multiforme that is has come back or did not respond to previous treatment with temozolomide. Lonafarnib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving lonafarnib together with temozolomide may kill more tumor cells.","other_id":"2004-0424","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with histologically proven supratentorial glioblastoma multiforme (GBM) or\r\n             gliosarcoma\r\n\r\n          -  Patients must have shown unequivocal evidence for tumor recurrence or progression by\r\n             magnetic resonance imaging (MRI) scan after radiation therapy; the scan done prior to\r\n             study entry documenting progression will be reviewed by the treating physician to\r\n             document tumor volume changes to provide a gross assessment of growth rate\r\n\r\n          -  Patients may have had as many as 2 prior chemotherapy regimens for recurrent or\r\n             progressive tumor; patients must have had prior treatment with Temodar but may not\r\n             have had prior treatment with farnesyl transferase inhibitors (Sarasar or Zarnestra);\r\n             patients in phase 1b expansion are required to have received a minimum of two cycles\r\n             of adjuvant temozolomide (TMZ)\r\n\r\n          -  All patients must sign an informed consent indicating that they are aware of the\r\n             investigational nature of this study in keeping with the policies of this hospital\r\n\r\n          -  Patients must have shown unequivocal evidence for tumor progression by MRI or computed\r\n             tomography (CT) scan; a scan should be performed within 14 days prior to registration\r\n             and on a steroid dose that has been stable or decreasing for at least 5 days; if the\r\n             steroid dose is increased between the date of imaging and registration a new baseline\r\n             magnetic resonance (MR)/CT is required; the same type of scan, i.e., MRI or CT must be\r\n             used throughout the period of protocol treatment for tumor measurement\r\n\r\n          -  Patients (pts) having had recent resection of recurrent or progressive tumor are\r\n             eligible as long as:\r\n\r\n               -  Patients must be status post surgical resection at least 2 weeks prior to study\r\n                  enrollment, have recovered from surgery, have adequate early wound healing and a\r\n                  Karnofsky performance status of > or = 60\r\n\r\n               -  Residual disease following resection of recurrent tumor is not mandated for\r\n                  eligibility into the study; a CT/MRI should be done within 96 hours (hrs) post-op\r\n                  or at least 4 weeks (wks) post-op (within 14 days of registration); if the\r\n                  steroid dose is increased between the scan date and registration, a new baseline\r\n                  MRI/CT is required on a stable steroid dose for 5 days\r\n\r\n          -  Patients must have a Karnofsky performance status of >= 60\r\n\r\n          -  Patients must have recovered from the toxic effects of prior therapy: 4 weeks from\r\n             prior cytotoxic therapy and/or at least two weeks from vincristine, 6 weeks from\r\n             nitrosoureas, 3 weeks from procarbazine administration, and 1 week for non-cytotoxic\r\n             agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc.\r\n             (radiosensitizer does not count); any questions related to the definition of\r\n             non-cytotoxic agents should be directed to the study chair\r\n\r\n          -  Absolute neutrophil count (ANC) >= 1,500/mm^3\r\n\r\n          -  Platelet count of >= 100,000/mm^3\r\n\r\n          -  Serum glutamic pyruvate transaminase (SGPT) < 2.5 times normal\r\n\r\n          -  Alkaline phosphatase < 2.5 times normal\r\n\r\n          -  Bilirubin < 1.5 mg\r\n\r\n          -  Blood urea nitrogen (BUN) < 1.5 times institutional normal\r\n\r\n          -  Creatinine < 1.5 times institutional normal\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients must not be taking primidone, carbamazepine, phenobarbital or phenytoin\r\n             anticonvulsants; patients changing from these anticonvulsants to other allowable drugs\r\n             that are not enzyme inducing antiepileptic drugs (EIAEDs) must be off the drugs listed\r\n             above for at least 72 hours prior the initiation of treatment\r\n\r\n          -  Patients with a history of any other cancer (except non-melanoma skin cancer or\r\n             carcinoma in-situ of the cervix), are ineligible unless in complete remission and off\r\n             of all therapy for that disease for a minimum of 3 years\r\n\r\n          -  Patients must not have:\r\n\r\n               -  Uncontrolled active infection\r\n\r\n               -  Disease that will obscure toxicity or dangerously alter drug metabolism\r\n\r\n               -  Serious intercurrent medical illness\r\n\r\n               -  Prior recurrence with a farnesyl transferase inhibitor\r\n\r\n               -  Oral contraceptives and other hormonal methods (Depo-Provera) of birth control\r\n      ","sponsor":"M.D. Anderson Cancer Center","sponsor_type":"Other","conditions":"Malignant Supratentorial Neoplasm|Recurrent Glioblastoma|Recurrent Gliosarcoma","interventions":[{"intervention_type":"Drug","name":"Drug: Lonafarnib","description":"Given PO"},{"intervention_type":"Drug","name":"Drug: Temozolomide","description":"Given PO"}],"outcomes":[{"outcome_type":"primary","measure":"Maximum tolerated dose (MTD) of lonafarnib when given with temozolomide, defined as the dose at which fewer than one-third of patients experience dose-limiting toxicity (DLT)","time_frame":"28 days"},{"outcome_type":"primary","measure":"Tolerability of regimen in patients with disease progression or recurrence during or after recent completion of treatment with temozolomide","time_frame":"Up to 11 years"},{"outcome_type":"secondary","measure":"Progression free survival (PFS)","time_frame":"6 months","description":"In the historical dataset, the proportion of patients remaining alive and free from progression at 6 months was 15% (95% confidence interval for ranged from 10% to 19%). We will set p0 to 15% and we will set p1 to 30% (looking for a doubling of the 6-month PFS rate). Based on these design parameters, a two-stage design would require that at least 4 of the initial 19 patients are without progression at 6 months."},{"outcome_type":"secondary","measure":"Objective response","time_frame":"Up to 11 years"},{"outcome_type":"secondary","measure":"Overall survival","time_frame":"Up to 11 years"},{"outcome_type":"secondary","measure":"Treatment-related toxicities","time_frame":"Up to 11 years","description":"Treatment-related toxicity data will be collected and described."}]}
{"nct_id":"NCT03413761","start_date":"2004-12-18","enrollment":1771,"brief_title":"Antioxidant Supplements, Genetics and Chemotherapy Outcomes","official_title":"Antioxidant Supplements, Genetics and Chemotherapy Outcomes","primary_completion_date":"2013-11-12","study_type":"Observational","rec_status":"Completed","completion_date":"2013-11-12","last_update":"2018-01-29","description":"This study will investigate the null hypothesis that use of antioxidant supplements during adjuvant chemotherapy will have no impact on toxicities and disease-free, as well as overall, survival, and also evaluate the role of polymorphisms in genes related to oxidative stress in relation to treatment outcomes.","other_id":"EPR 43304","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"Woman from SWOG trial S0221 with node-positive or high-risk node-negative breast cancer.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically confirmed diagnosis of operable Stage 1, II, or III invasive breast\r\n             cancer with known estrogen or progesterone receptor status\r\n\r\n          -  high risk by meeting at least one of the following criteria:\r\n\r\n               1. tumor >= 2 cm in greatest diameter\r\n\r\n               2. one or more axillary or intramammary nodes are involved by metastatic breast\r\n                  cancer\r\n\r\n          -  had either a modified radical mastectomy or local excision of all tumors plus axillary\r\n             node dissection or sentinel node resection\r\n\r\n          -  not received prior chemotherapy or radiation therapy for the current malignancy\r\n\r\n          -  no history of congestive heart failure or angina pectoris\r\n\r\n          -  normal creatinine and bilirubin, alkaline phosphatase and SGOT or SGPT 2 x the\r\n             institutional upper limits of normal\r\n\r\n          -  ANC greater than or equal to 1,200 ul and platelet count of greater than or equal\r\n             100,000 U1\r\n\r\n          -  No previous malignancies\r\n\r\n          -  Age 18 or greater\r\n\r\n          -  Performance status of 0 -2 by Zubrod criteria\r\n\r\n          -  HIV negative (if known)\r\n      ","sponsor":"Roswell Park Cancer Institute","sponsor_type":"Other","conditions":"Node Positive Breast Cancer|Node Negative Breast Cancer","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Epidemiologic Questionnaire","time_frame":"At baseline interview","description":"Self administered questionnaire to evaluate use of antioxidant supplements in relation to toxicity"},{"outcome_type":"primary","measure":"Evaluate if variants in genes are associate with treatment related toxicities","time_frame":"Prior to treatment","description":"Polymorphisms will be determined by sequencing as described in detail on the National Cancer Institute'sSNP500Cancer database"},{"outcome_type":"primary","measure":"Evaluate if variants in genes are associate with treatment related toxicities","time_frame":"Year 5","description":"Polymorphisms will be determined by sequencing as described in detail on the National Cancer Institute'sSNP500Cancer database"},{"outcome_type":"primary","measure":"Epidemiologic Questionnaire","time_frame":"every 6 months for 5 years","description":"Self administered questionnaire to evaluate use of antioxidant supplements in relation to disease free survival"}]}
{"nct_id":"NCT01155232","start_date":"2004-11-30","enrollment":100,"brief_title":"Effects of Teriparatide (PTH) on Bone in Men and Women With Osteoporosis","official_title":"Effect of 24 Months of Teriparatide Therapy on Bone Microarchitecture and Bone Volume in Men and Women With Osteoporosis","primary_completion_date":"2021-01-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2022-01-31","last_update":"2020-09-30","description":"Teriparatide (PTH) is the only bone formation therapy that has been approved for the treatment of postmenopausal osteoporosis in Canada. Osteoporosis is currently diagnosed using a bone mineral density (BMD) scan, which measures the amount of mineral (calcium etc) in bones (the higher the amount of mineral, the lower the fracture risk). Although BMD is linked to bone strength and is used to measure fracture risk, it does not give information on bone structure (called bone geometry) which can also tell us a great deal about fracture risks. Clinical trials have shown that teriparatide increases BMD at the lumbar spine and total hip, while BMD at the forearm may decrease after 20 months of therapy. However, bone biopsies of the pelvis done on people taking teriparatide show improvement of bone geometry (ie bone thickness and increased trabeculae (small interconnecting rods of bone), suggesting that a change in bone geometry at the wrist may be occurring as well. Currently, there is a new technology, high resolution pQCT (HR-pQCT) that can assess bone geometry without a biopsy. Since bone strength is affected both by BMD and bone structure (as well as other material properties), our group is interested in examining changes in bone geometry at the radius and tibia in men and women with osteoporosis who receives 24 months of teriparatide therapy. The investigators believe that this new approach of measuring bone strength will help us better understand the mechanisms of therapeutic efficacy of teriparatide. In addition, measuring indices of bone strength such as the material composition (bone mineral content or BMD) and structural properties of bone (size and shape, and microarchitecture) may provide more data about the mechanisms of how teriparatide treatment can decrease fracture risk. In the end, this data will benefit and improve patient care by allowing us to show patients and their providers that whether BMD increases, decreases or stay the same, there are changes in their bone geometric structure with teriparatide therapy that increases bone strength.","other_id":"PTH 04-0655AE","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","population":"community dwelling men and women with osteoporosis who have been prescribed teriparatide\r\n        for severe osteoporosis. (Teriparatide is not supplied as part of this study)","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  History of fragility fracture OR\r\n\r\n          -  High risk for fractures OR\r\n\r\n          -  Very low BMD (T-score  -2.5) OR\r\n\r\n          -  Failed or intolerant to bisphosphonates\r\n\r\n          -  Baseline serum levels of calcium, urate, ALP, PTH, creatinine and 25- hydroxyvitamin D\r\n             [25(OH)D] must be within acceptable normal limits\r\n\r\n          -  Ability to obtain teriparatide (not supplied by study sponsor)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of skeletal irradiation\r\n\r\n          -  Those at increased risk for osteosarcoma\r\n\r\n          -  Diagnosis of Paget's disease\r\n\r\n          -  History of primary hyperparathyroidism\r\n\r\n          -  Significant renal impairment\r\n\r\n          -  Vitamin D deficiency\r\n\r\n          -  On steroids or have other causes of secondary osteoporosis\r\n      ","sponsor":"University Health Network, Toronto","sponsor_type":"Other","conditions":"Osteoporosis","interventions":[{"intervention_type":"Drug","name":"Drug: Teriparatide","description":"Forteo (teriparatide)pen daily for 24 months"}],"outcomes":[{"outcome_type":"primary","measure":"Change in cortical thickness at the radius and tibia as measured by high-resolution quantitative computer tomography (HR-pQCT)","time_frame":"0-24 months"}]}
{"nct_id":"NCT00283283","start_date":"2004-11-30","phase":"Phase 2","enrollment":1316,"brief_title":"Comparison of Full-dose Flu Vaccine to Half-dose Flu Vaccine","official_title":"Clinical Study to Compare the Immune Response of Half Dose Trivalent Inactivated Influenza Vaccine (TIV) to Full Dose","primary_completion_date":"2004-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2006-05-31","last_update":"2021-02-12","description":"This study compared full-dose Flu vaccine to half-dose Flu-vaccine during the 2004-2005 flu season.","other_id":"A-13205","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":64,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Able to understand and comply with all study procedures including availability for all\r\n             study visits and follow up surveys within 6 months following study enrollment.\r\n\r\n          -  DEERS eligible beneficiaries eligible for influenza vaccination and able to give\r\n             informed consent.\r\n\r\n          -  Age 18-49\r\n\r\n               -  Patients presenting to travel clinic with no exclusion criteria;\r\n\r\n               -  Household contacts and out-of-home caretakers of infants from 6-23 months of age;\r\n\r\n               -  Hospital and/or employees providing service to the public who are not eligible\r\n                  for the post-October 5th recommendations for priority immunization;\r\n\r\n               -  DOD employees eligible for influenza vaccination prior to October 5th but\r\n                  excluded in the post October 5th guidelines;\r\n\r\n               -  People living in dormitories or under other crowded conditions, to prevent\r\n                  outbreaks;\r\n\r\n          -  Ages 50-64 years of age who are not eligible for the post-October 5th recommendations\r\n             for priority immunization and with no standard of care contraindications to\r\n             vaccination.\r\n\r\n          -  Eligible in the Department of Defense for influenza vaccination\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  all children aged < 18 years (includes children aged 6 months-18 years on chronic\r\n             aspirin therapy);\r\n\r\n          -  adults aged >65 years;\r\n\r\n          -  persons aged 2-64 years with underlying chronic medical conditions:\r\n\r\n               -  includes persons with chronic cardiac or pulmonary disease, diabetes mellitus,\r\n                  hemoglobinopathy, or immunosuppressive illness;\r\n\r\n               -  any acute or chronic condition that, in the opinion of the investigator, would\r\n                  render vaccination unsafe or interfere with the evaluation of response.\r\n\r\n          -  use of experimental vaccines or medications within 30 days of study entry;\r\n\r\n          -  receipt of parenteral immunoglobulin within 60 days of study entry;\r\n\r\n          -  all women who will be pregnant during the influenza season;\r\n\r\n          -  residents of nursing homes and long-term care facilities;\r\n\r\n          -  health-care workers involved in direct patient care and included in DOD priority 1;\r\n             and;\r\n\r\n          -  military recruits;\r\n\r\n          -  out-of-home caregivers and household contacts of children aged <6 months.\r\n\r\n          -  Anyone with clinical contraindications for receiving the inactivated influenza vaccine\r\n             such as a history of severe allergic reaction to prior influenza vaccinations, severe\r\n             allergy to egg and/or egg proteins and gelatin.\r\n\r\n          -  DOD Priority 1: Deployed or deploying (with orders) service members and others\r\n             designated as critical to national defense.\r\n\r\n          -  DOD Priority 2: Medically high risk in accordance with ACIP guidelines (includes\r\n             health-care workers with direct patient contact)\r\n\r\n          -  Any acute or chronic condition that, in the opinion of the investigator or her\r\n             provider designee would render vaccination unsafe or interfere with the evaluation of\r\n             the response.\r\n      ","sponsor":"U.S. Army Medical Research and Development Command","sponsor_type":"U.S. Fed","conditions":"Influenza","interventions":[{"intervention_type":"Biological","name":"Biological: Fluzone (Aventis Pasteur inactivated influenza vaccine)","description":"A/H1N1, A/New Caledonia/20/99; A/H3N2, A/Fujian/411/2002; B, B/Shanghai/361/2002"}],"outcomes":[{"outcome_type":"primary","measure":"Immune Response: Age 18-49","time_frame":"21 days post-vaccincation","description":"Immune response as measured by viral strain specific hemaggluttination inhibition (HAI) antibody levels for subjects ages 18-49"},{"outcome_type":"primary","measure":"Immune Response: Age 50-64","time_frame":"21 days post-vaccincation","description":"Immune response as measured by viral strain specific hemaggluttination inhibition (HAI) antibody levels for subjects ages 50-64"},{"outcome_type":"secondary","measure":"Medical Events: Unsolicited Adverse Events","time_frame":"3 - 6 months following vaccination","description":"Assessed through following subjects' recording of oral body temperature, completion of a 21-day symptom diary; subjects' completion of longer-term follow-up surveys to track respiratory symptoms; and a review of the Defense Medical Surveillance System (DMSS) hospitalization and outpatient medical visits database in order to track ICD-9 codes relevant to flu-like illness."},{"outcome_type":"other","measure":"Race/Ethnicity Baseline Measure","time_frame":"Enrollment Day","description":"Race/ethnicity data was only collected by age and cannot be separated out by dose as per the other Baseline Measures"}]}
{"nct_id":"NCT00180882","start_date":"2004-10-31","phase":"Phase 3","enrollment":260,"brief_title":"LMBA02 Protocol for Patients With a Burkitt Lymphoma","study_type":"Interventional","rec_status":"Unknown status","last_update":"2006-09-11","description":"To explore in a multicenter international prospective randomized study (phase III) whether rituximab combined with the standard French LMB chemotherapy scheme results in a higher rate of EFS than the LMB chemotherapy scheme alone in patients older than 18 years with Burkitt lymphoma or ALL 3.","other_id":"LMBA02","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age : 18 years or older\r\n\r\n          -  Histologically or cytologically proven Burkitt lymphoma according to the WHO\r\n             classification\r\n\r\n          -  WHO performance < 3\r\n\r\n          -  Informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Known HIV positive infection\r\n\r\n          -  Positive serology for HCV and HBV (except after vaccination)\r\n\r\n          -  Patients previously treated for lymphoma\r\n\r\n          -  cardiac disease that contradict anthracycline chemotherapy\r\n\r\n          -  Psychological or psychiatric condition who contradict steroids therapy\r\n\r\n          -  Patients with serious renal failure unrelated to the lymphoma (serum creatinin level\r\n             higher than 150 mmole/L)\r\n\r\n          -  Cirrhosis or severe hepatic failure unrelated to the lymphoma\r\n\r\n          -  Previous malignant disease except basal cell skin carcinoma or in situ uterine cervix\r\n             carcinoma\r\n\r\n          -  Any psychological, familial, sociological or geographical condition potentially\r\n             hampering compliance with the study protocol and follow-up schedule\r\n\r\n          -  Primary organ transplant or other immunosuppressive conditions Pregnancy\r\n      ","sponsor":"Gustave Roussy, Cancer Campus, Grand Paris","sponsor_type":"Other","conditions":"Burkitt Lymphoma","interventions":[{"intervention_type":"Drug","name":"Drug: rituximab"}],"outcomes":[{"outcome_type":"primary","measure":"Event free survival from date of first randomization"},{"outcome_type":"secondary","measure":"Complete and partial response rate, overall survival, toxicity"}]}
{"nct_id":"NCT00192023","start_date":"2004-10-31","phase":"Phase 3","enrollment":139,"brief_title":"An Italian Study of the Efficacy of Atomoxetine in the Treatment of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD) and Comorbid Oppositional Defiant Disorder (ODD).","official_title":"An Italian Randomised, Double-blind Placebo Controlled Study of the Efficacy of Atomoxetine Hydrochloride in the Treatment of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder and Comorbid Oppositional Defiant Disorder","primary_completion_date":"2006-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-05-31","last_update":"2010-01-18","description":"The study is a phase IIIb multicentre, randomised, placebo controlled, trial in paediatric patients with Attention-Deficit/Hyperactivity (ADHD) and Oppositional Defiant Disorder (ODD). The primary aim of the study is to evaluate the efficacy of atomoxetine in improving ADHD and ODD symptoms in patients non responders to a previous psychological intervention with parent support. Moreover, the potential role of atomoxetine in treating other psychiatric comorbid conditions associated with ADHD and ODD will be assessed.","other_id":"8856","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":6,"maximum_age":15,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Child or adolescent patients, male or female outpatients, who are at least 6 years of\r\n             age, but must not yet have reached their 16th birthday prior to Visit 1, when informed\r\n             consent is obtained.\r\n\r\n          -  Patients must meet Diagnostic and Statistical Manual of Mental Disorders Fourth\r\n             Edition (DSM-IV) diagnostic criteria for ADHD (any subtype) and ODD and score at least\r\n             1.5 standard deviations above the age norm for their diagnostic subtype using\r\n             published norms for the Swanson, Nolan and Pelham Questionnaire:\r\n             Attention-Deficit/Hyperactivity Disorder (SNAP-IV ADHD) Subscale score at both Visit 1\r\n             and 2.\r\n\r\n          -  They must also have a SNAP-IV ODD subscale score of at least 15 at both Visit 1 and\r\n             Visit 2.\r\n\r\n          -  Other comorbid conditions, are allowed but the diagnosis of ADHD and ODD must be the\r\n             patient's primary diagnosis.\r\n\r\n          -  Patients must be of normal intelligence in the judgment of the investigator (that is,\r\n             without a general impairment of intelligence and likely, in the investigator's\r\n             judgement, to achieve a score of greater than or equal to 70 on an Intelligence\r\n             Quotient (IQ) test). The administration of a formal IQ test is not an entry\r\n             requirement for the study. Specific learning disabilities are not considered general\r\n             impairment of intelligence.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who weigh less than 20 kilograms (kg) at study entry (Visit 1).\r\n\r\n          -  Patients who have a documented history of Bipolar I or II disorder, any history of\r\n             psychosis or pervasive development disorder.\r\n\r\n          -  Patients with a history of any seizure disorder (other than febrile seizures) or\r\n             patients who have taken (or are currently taking) anticonvulsants for seizure control\r\n             are not eligible to participate.\r\n\r\n          -  Patients at serious suicidal risk as assessed by the investigator.\r\n\r\n          -  Patients who, in the investigator's judgment, are likely to need psychotropic\r\n             medications apart from the drug under the study, including health-food supplements\r\n             that the investigator feels have central nervous system activity (for example, St.\r\n             John's Wort, melatonin).\r\n      ","sponsor":"Eli Lilly and Company","sponsor_type":"Industry","conditions":"Attention Deficit Hyperactivity Disorder|Oppositional Defiant Disorder","interventions":[{"intervention_type":"Drug","name":"Drug: atomoxetine 0.5 mg/kg/day","description":"atomoxetine 0.5 milligrams per kilogram per day (mg/kg/day) daily (QD), by mouth (PO)"},{"intervention_type":"Drug","name":"Drug: placebo"},{"intervention_type":"Drug","name":"Drug: atomoxetine 1.2 mg/kg/day","description":"atomoxetine 1.2 mg/kg/day QD, PO"},{"intervention_type":"Drug","name":"Drug: atomoxetine 1.2-1.4 mg/kg/day","description":"atomoxetine 1.2 - 1.4 mg/kg/day QD, PO"}],"outcomes":[{"outcome_type":"primary","measure":"Change From Baseline to 8 Week Endpoint in Swanson, Nolan and Pelham Questionnaire (SNAP-IV): Attention-Deficit/Hyperactivity Disorder (ADHD) Subscale","time_frame":"Visit 8 (baseline) and Visit 14 (8 weeks)","description":"Items from the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for ADHD are included for the two subsets of symptoms: inattention (items #1-#9) and hyperactivity/impulsivity (items #11-#19). The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total subscale scores range from 0 to 54."},{"outcome_type":"secondary","measure":"Change From Baseline to 8 Week Endpoint in Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder (ADHD) - Severity","time_frame":"Visit 8 (baseline) and Visit 14 (8 weeks)","description":"Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients."},{"outcome_type":"secondary","measure":"Change From Baseline to 8 Week Endpoint in SNAP-IV Oppositional Subscale","time_frame":"Visit 8 (baseline) and Visit 14 (8 weeks)","description":"Items are included from the DSM-IV criteria for Oppositional Defiant Disorder (items #21-#28). The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total subscale scores range from 0 to 24."},{"outcome_type":"secondary","measure":"Change From Baseline to 8 Week Endpoint in Screen for Child Anxiety Related Emotional Disorders (SCARED) Total Score","time_frame":"Visit 8 (baseline) and Visit 14 (8 weeks)","description":"The scale measures symptoms of DSM-IV linked anxiety disorders in children. Contains 41 items. Individual item scores range from 0 (not true or hardly ever true) to 2 (very true or often true). Therefore, the overall score ranges from 0 to 82. Higher scores are more indicative of greater anxiety."},{"outcome_type":"secondary","measure":"Change From Baseline to 8 Week Endpoint in Children's Depression Rating Scale-Revised","time_frame":"Visit 8 (baseline) and Visit 14 (8 weeks)","description":"Measures presence and severity of depression. Consists of 17 items scored on a 1-5 or 1-7 scale. A rating of 1 indicates normal, thus the minimum score is 17. The maximum score is 113. In general, scores below 20 indicate an absence of depression; scores of 20 or 30 indicate borderline depression; scores of 40 to 60 indicate moderate depression."},{"outcome_type":"secondary","measure":"Change From Baseline to 8 Week Endpoint in Conners' Parent Rating Scale-Revised: Short Form Subscale Scores","time_frame":"Visit 8 (baseline) and Visit 14 (8 weeks)","description":"A 27-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the parent to assess problem behaviors related to ADHD. Subscales: Oppositional, Cognitive Problems, Hyperactivity, and ADHD Index. Subscale total scores range from 0 to 18 for all subscales except ADHD Index which ranges from 0 to 36."},{"outcome_type":"secondary","measure":"Change From Baseline to 8 Week Endpoint in Child Health and Illness Profile - Child Edition (CHIP-CE): Parent Rated Form","time_frame":"Visit 8 (baseline) and Visit 14 (8 weeks)","description":"Parent-rated assessment of a child's health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, 'how good is your child at making friends?' 1=never, 5=always). Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Standard scores are expressed in standard deviation units. T-score=[(score-4.2382)*10/0.32835] + 50. Higher scores mean improvement."},{"outcome_type":"secondary","measure":"Change From Baseline to 8 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form Subscale Scores","time_frame":"Visit 8 (baseline) and Visit 14 (8 weeks)","description":"A 28-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the teacher to assess problem behaviors related to ADHD. Subscale total scores range from 0 to 15 for Oppositional and Cognitive Problems, 0 to 21 for Hyperactivity, and 0 to 36 for ADHD Index."},{"outcome_type":"other","measure":"Open-Label Phase Serious Adverse Events","time_frame":"Baseline (Visit 14) though 1.5 years (Visit 20) or until atomoxetine received marketing approval","description":"Number of participants with serious adverse events during the open-label phase of the trial, which was for 1.5 years or until atomoxetine received marketing approval."},{"outcome_type":"other","measure":"Open-Label Phase Nonserious Adverse Events","time_frame":"Baseline (Visit 14) though 1.5 years (Visit 20) or until atomoxetine received marketing approval","description":"Number of participants with nonserious adverse events during the open-label phase of the trial, which was for 1.5 years or until atomoxetine received marketing approval."}]}
{"nct_id":"NCT01163773","start_date":"2004-10-31","phase":"N/A","enrollment":29,"brief_title":"Milk Consumption and the Metabolic Syndrome in Menopausal Women","official_title":"Milk Consumption and the Metabolic Syndrome in Menopausal Women","primary_completion_date":"2005-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2006-06-30","last_update":"2010-07-16","description":"Cardiovascular disease (CVD) represents the first cause of mortality in industrialized countries such as Canada and the United States. In that regard, it is being increasingly recognized that a significant proportion of CVD events may be attributable to the presence of a cluster of metabolic and physiological perturbations defined as the metabolic syndrome (MetS). The National Cholesterol Education Program- Adult Treatment Panel III (NCEP-ATP III) has recently proposed a clinical definition to identify individuals with the MetS. This definition is based on the presence of at least three of the following five characteristics: 1- abdominal obesity, 2- hypertriglyceridemia, 3- reduced plasma HDL-C levels, 4- high blood pressure, 5- high fasting blood glucose levels. Recent data have suggested that the MetS based on this definition was associated with a 2 to 5 fold increase in the risk of CVD in men as well as in women. These are alarming figures since it has been suggested that as much as 35 to 45% of female aged > 65 years in the US may have the MetS. It is therefore imperative to develop new preventive strategies that will be efficacious in attenuating the impact of the MetS on the progressing rates of CVD in women. In that context, there is accumulating evidence to suggest that milk and dairy products may beneficially modify several components of the MetS. However, most of the available data to date are based on observational studies or interventional studies with minimal nutritional control. Thus, metabolically controlled studies that document the impact of milk consumption on cardiovascular risk factors associated with the MetS in women defined a priori as having the MetS are utterly lacking. The purpose of this study was to investigate the impact of milk consumption on features of the MetS in menopausal women presenting one or more features of the MetS.","other_id":"INAF-2004-039","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":45,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Menopausal women (absence of menses > 12 months and FSH > 40 IU/ml), aged between 45\r\n             and 65 years\r\n\r\n          -  Presenting 1 or more features of the MetS based on the NCEP-ATP III definition\r\n\r\n          -  Average consumption of milk/dairy products fewer than 2 portions/d ( 1.9)\r\n\r\n          -  Stable body weight (+/- 2 kg) for 6 months before the beginning of the study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Previous history of cardiovascular disease, type 2 diabetes and monogenic dyslipidemia\r\n\r\n          -  Subjects taking medications for hyperlipidemia, hypertension or hormonal replacement\r\n             therapy\r\n\r\n          -  Endocrine disorders\r\n\r\n          -  Smoking\r\n\r\n          -  Food allergies, milk aversion or intolerant to lactose\r\n\r\n          -  Women with extreme nutritional habits such as vegetarism or alcohol consumption > 2\r\n             drinks/day\r\n      ","sponsor":"Laval University","sponsor_type":"Other","conditions":"Cardiovascular Disease","interventions":[{"intervention_type":"Other","name":"Other: MILK","description":"Consumption of the 2 experimental diets\r\nMilk diet\r\nControl diet"}],"outcomes":[{"outcome_type":"primary","measure":"Plasma TG levels (MetS criteria)","time_frame":"At the beginning and the end of the two 6-week diets"},{"outcome_type":"primary","measure":"HDL-C levels (MetS criteria)","time_frame":"At the beginning and the end of the two 6-week diets"},{"outcome_type":"primary","measure":"Systolic and diastolic blood pressure (MetS criteria)","time_frame":"At the beginning and the end of the two 6-week diets"},{"outcome_type":"primary","measure":"Fasting blood glucose (MetS criteria)","time_frame":"At the beginning and the end of the two 6-week diets"},{"outcome_type":"secondary","measure":"Anthropometric measures (waist and hip circumferences)","time_frame":"At the beginning and the end of the two 6-week diets"},{"outcome_type":"secondary","measure":"LDL and HDL particle size","time_frame":"At the beginning and the end of the two 6-week diets"},{"outcome_type":"secondary","measure":"Markers of the oxidative stress (i.e. oxLDL and 8-iso-PGF2a levels)","time_frame":"At the beginning and the end of the two 6-week diets"},{"outcome_type":"secondary","measure":"Markers of a pro-inflammatory state (i.e. C-reactive protein and IL-6 levels)","time_frame":"At the beginning and the end of the two 6-week diets"},{"outcome_type":"secondary","measure":"Surrogates of cholesterol absorption and synthesis","time_frame":"At the beginning and the end of the two 6-week diets"}]}
{"nct_id":"NCT00234143","start_date":"2004-10-31","phase":"Phase 2/Phase 3","enrollment":360,"brief_title":"Erythropoietin (EPO) and Granulocyte-Colony Stimulating Factor (G-CSF) for Low-Risk Myelodysplastic Syndromes (MDS)","official_title":"A Randomised Controlled Trial of Prolonged Treatment With Darbepoetin Alpha With or Without Recombinant Human Granulocyte Colony Stimulating Factor (G-CSF) Versus Best Supportive Care in Patients With Low-Risk Myelodysplastic Syndromes","study_type":"Interventional","rec_status":"Unknown status","last_update":"2009-03-12","description":"Myelodysplastic syndromes (MDS) are acquired clonal disorders of the bone marrow. The clinical consequences of MDS are bone marrow failure and a predisposition to develop acute myeloid leukaemia (AML). Patients with 'low risk MDS' have less than 10% myeloblasts in the marrow and include the World Health Organization (WHO) subtypes refractory anaemia (RA), refractory anaemia with ring sideroblasts (RARS) and refractory anaemia with excess blasts-I (RAEB-I). This group of patients has a relatively low risk of leukaemic transformation and the major clinical problem is the manifestation of bone marrow failure. Up to 80% of these patients become red cell transfusion dependent. To date, the only curative therapy is allogeneic stem cell transplantation. Unfortunately, a median age at diagnosis of > 65 years excludes this type of therapy for most patients with MDS. The aim of treatment is, therefore, supportive therapy. Long term red cell transfusion therapy carries the problems of acute transfusion reactions: iron overload, alloantibody formation, poor venous access and the risk of transfusion transmitted infection. With time, such patients require increasing frequency of transfusion and obtain decreased length of benefit from transfusion. The quality of life of such patients is significantly reduced. Alternative therapies, therefore, aimed at promoting more effective haemopoiesis and reducing the need for red cell transfusion may improve quality of life, reduce the use of expensive resources such as red cells and iron chelation, and perhaps enhance survival. Combined darbepoetin alfa (Aranesp) plus G-CSF (Neupogen; filgrastim) in low risk MDS is better than best supportive care, with respect to haemoglobin and quality of life. The study will assess: - the costs of this approach - long-term outcomes - clinical/laboratory parameters allowing early cessation of therapy in patients destined not to respond","other_id":"04/Q1907/94","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  A confirmed diagnosis of MDS - WHO type:\r\n\r\n               -  refractory anaemia (RA)\r\n\r\n               -  hypoplastic RA ineligible for or failed immunosuppressive therapy (ALG,\r\n                  cyclosporine)\r\n\r\n               -  refractory anaemia with ring sideroblasts (RARS)\r\n\r\n               -  refractory cytopenia with multilineage dysplasia\r\n\r\n               -  myelodysplastic syndrome unclassifiable\r\n\r\n          -  IPSS low or Int-1, but with BM blasts <5%\r\n\r\n          -  A haemoglobin concentration of < 10g/dl and/or red cell transfusion dependence\r\n\r\n          -  Written informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  MDS with bone marrow blasts 5%\r\n\r\n          -  Myelodysplastic syndrome associated with del(5q)(q31-33) syndrome\r\n\r\n          -  Chronic myelomonocytic leukaemia (monocytes >1.0x109/l)\r\n\r\n          -  therapy-related MDS\r\n\r\n          -  Splenomegaly, with spleen  5 cm from left costal margin\r\n\r\n          -  Platelets <30x109/l\r\n\r\n          -  Uncorrected haematinic deficiency\r\n\r\n          -  Age less than 18 years\r\n\r\n          -  Woman who are pregnant or lactating\r\n\r\n          -  Women of child bearing age unless using reliable contraception\r\n\r\n          -  Life expectancy < 6 months\r\n\r\n          -  Uncontrolled hypertension, previous venous thromboembolism, or uncontrolled cardiac or\r\n             pulmonary disease\r\n\r\n          -  Previous adverse events to the study medications or its components\r\n\r\n          -  Patients who have had previous therapy with EPO  G-CSF within 4 weeks of study entry\r\n\r\n          -  Patients currently receiving experimental therapy, e.g. with thalidomide, or who are\r\n             participating in another clinical trial\r\n\r\n          -  Medical or psychiatric illness, which makes the patient unsuitable or unable to give,\r\n             informed consent.\r\n      ","sponsor":"St. Bartholomew's Hospital","sponsor_type":"Other","conditions":"Myelodysplastic Syndromes","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Darbepoetin and Filgrastim","description":"Aranesp and Neupogen G-CSF (Neupogen) 300 mcg s.c. twice a week, 3-4 days apart and EPO (Aranesp) 500 mcg s.c. once every 2 weeks until week 24, titrate depending of response"},{"intervention_type":"Drug","name":"Drug: Darbepoetin","description":"Aranesp EPO (Aranesp) 500 mcg s.c. once every 2 weeks until 24 weeks, titrate depending of response"}],"outcomes":[{"outcome_type":"primary","measure":"Quality of life (Functional Assessment of Cancer Therapy-Anemia [FACT-An] and EuroQOL-5D [EQ-5D])","time_frame":"at week 0, 12, 24, 36 and 52"},{"outcome_type":"secondary","measure":"Overall erythroid response (major and minor) at 6 months as defined by the Cheson criteria","time_frame":"week 24"},{"outcome_type":"secondary","measure":"Overall erythroid response (major and minor) at 2 and 12 months as defined by the Cheson criteria","time_frame":"week 8 and 52"},{"outcome_type":"secondary","measure":"Incidence of disease progression (i.e. to RAEB or AML) and overall survival","time_frame":"every 4 weeks until week 24 and at week 36 and 52"},{"outcome_type":"secondary","measure":"Multivariate analysis of prospective laboratory variables in order to generate a prognostic model","time_frame":"every 4 weeks until week 24 and at week 36 and 52"},{"outcome_type":"secondary","measure":"Economic costs of managing anaemia in both arms of the study","time_frame":"every 4 weeks until week 24 and at week 36 and 52"}]}
{"nct_id":"NCT00715403","start_date":"2004-10-31","phase":"Phase 1","enrollment":41,"brief_title":"A Phase I/II Open Label Extension Study of BIBF 1120 Administered Orally Once or Twice Daily to Establish Safety, Pharmacokinetics and Efficacy in Patients With Advanced Solid Tumours and Clinical Benefit From Previous Therapy With BIBF 1120","official_title":"Extension Study to Establish Safety, Pharmacokinetics and Efficacy of BIBF 1120 in Patients With Previous Clinical Benefit From BIBF 1120","primary_completion_date":"2009-09-30","study_type":"Interventional","rec_status":"Completed","last_update":"2014-12-02","description":"The primary objective of this trial is to evaluate the long-term safety of BIBF 1120 in terms of incidence and intensity of Adverse Events and changes in safety laboratory parameters. Secondary objectives are the collection of further safety data (vital signs), efficacy data and the determination of pharmacokinetic characteristics during long-term therapy with BIBF 1120.","other_id":"1199.16","primary_purpose":"Treatment","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Male or female patients with advanced solid tumours who have completed a previous\r\n             study with BIBF 1120. The patients should not have progression of their underlying\r\n             tumour disease unless there is evidence for significant clinical benefit (e.g. symptom\r\n             improvement) from treatment with BIBF 1120.\r\n\r\n          2. Age 18 years or older\r\n\r\n          3. Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score <= 2\r\n\r\n          4. Patients must have given written informed consent (which must be consistent with\r\n             ICH-GCP and local legislation)\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Time elapsed from last administration of BIBF 1120 in the previous trial to start of\r\n             treatment in the present trial exceeds four weeks\r\n\r\n          2. Presence of drug related toxicity > grade 2 CTC from previous therapy with BIBF 1120\r\n             or presence of drug related continuous toxicity of grade 2 for seven or more\r\n             consecutive days which would preclude ongoing chronic therapy with BIBF 1120\r\n\r\n          3. Active ulcers (gastro-intestinal tract, skin)\r\n\r\n          4. Major injuries and surgery within the past three weeks with incomplete wound healing\r\n\r\n          5. Hypersensitivity to BIBF 1120 or the excipients of the trial drug\r\n\r\n          6. Known secondary malignancy requiring therapy\r\n\r\n          7. Active infectious disease\r\n\r\n          8. Significant cardiovascular diseases (i.e. uncontrolled severe hypertension, unstable\r\n             angina pectoris, history of myocardial infarction, congestive heart failure > NYHA II)\r\n\r\n          9. Gastrointestinal disorders anticipated to interfere with the resorption of the study\r\n             drug\r\n\r\n         10. Brain metastases requiring therapy\r\n\r\n         11. Absolute neutrophil count less than 1,500/mm3\r\n\r\n         12. Platelet count less than 100,000/mm3\r\n\r\n         13. Bilirubin greater than 1.5 mg/dl (> 26 mol/L)\r\n\r\n         14. Aspartate amino transferase (AST) and/or alanine amino transferase (ALT) greater than\r\n             2.5 times the upper limit of normal (if related to liver metastases greater than five\r\n             times the upper limit of normal)\r\n\r\n         15. Serum creatinine greater than 2 mg/dl (> 176 mol/L)\r\n\r\n         16. Concomitant non-oncological diseases which are considered relevant for the evaluation\r\n             of the safety of the trial drug\r\n\r\n         17. Chemo-, radio-, or immunotherapy within the past four weeks prior to treatment with\r\n             the trial drug\r\n\r\n         18. Patients who are sexually active and unwilling to use a medically acceptable method of\r\n             contraception\r\n\r\n         19. Pregnancy or lactation\r\n\r\n         20. Treatment with other investigational drugs or participation in another clinical trial\r\n             within the past four weeks before start of therapy (visit 2) or concomitantly with\r\n             this trial (except for a previous study with BIBF 1120)\r\n\r\n         21. Patients unable to comply with the protocol\r\n\r\n         22. Active alcohol or drug abuse\r\n      ","sponsor":"Boehringer Ingelheim","sponsor_type":"Industry","conditions":"Neoplasms","interventions":[{"intervention_type":"Drug","name":"Drug: BIBF 1120"}],"outcomes":[{"outcome_type":"primary","measure":"Difference From Baseline for Liver Enzymes","time_frame":"From signing the informed consent until end of treatment, up to 991 days","description":"Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25."},{"outcome_type":"primary","measure":"Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1","time_frame":"From signing the informed consent until final follow-up, up to 991 days","description":"All patients who had grade 1 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE)."},{"outcome_type":"primary","measure":"Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2","time_frame":"From signing the informed consent until final follow-up, up to 991 days","description":"All patients who had grade 2 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE)."},{"outcome_type":"primary","measure":"Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3","time_frame":"From signing the informed consent until final follow-up, up to 991 days","description":"All patients who had grade 3 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE)."},{"outcome_type":"primary","measure":"Incidence and Intensity of Adverse Events With Highest CTCAE Grade 4","time_frame":"From signing the informed consent until final follow-up, up to 991 days","description":"All patients who had grade 4 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE)."},{"outcome_type":"primary","measure":"Incidence and Intensity of Adverse Events With Highest CTCAE Grade 5","time_frame":"From signing the informed consent until final follow-up, up to 991 days","description":"All patients who had grade 5 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE)."},{"outcome_type":"primary","measure":"Difference From Baseline for Bilirubin, Creatinine and Glucose","time_frame":"From signing the informed consent until end of treatment, up to 991 days","description":"Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25."},{"outcome_type":"primary","measure":"Difference From Baseline for Haemoglobin","time_frame":"From baseline until end of treatment, up to 991 days","description":"Difference from baseline for Haemoglobin (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25."},{"outcome_type":"primary","measure":"Difference From Baseline for Haematology and Differentials Parameters","time_frame":"From signing the informed consent until end of treatment, up to 991 days","description":"Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25."},{"outcome_type":"primary","measure":"Difference From Baseline for Coagulation Parameters","time_frame":"From signing the informed consent until end of treatment, up to 991 days","description":"Difference from baseline (normalized value) in coagulation parameters Prothrombin time, international normalised ratio (PT-INR) and partial thromboplastin time. Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25."},{"outcome_type":"primary","measure":"Difference From Baseline for Electrolytes","time_frame":"From signing the informed consent until end of treatment, up to 991 days","description":"Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25."},{"outcome_type":"secondary","measure":"Clinically Relevant Abnormalities for Vital Signs","time_frame":"From baseline until final follow-up, up to 991 days","description":"Clinically relevant abnormalities for Vital Signs (systolic blood pressure, diastolic blood pressure, and pulse rate). New abnormal findings or worsening of baseline conditions were reported as Adverse Events."},{"outcome_type":"secondary","measure":"Pre-dose Concentration of Nintedanib in Plasma at Steady-state (Cpre,ss)","time_frame":"Just before drug administration every 28±7 days after day 29","description":"Cpre,ss represents the pre-dose concentration of Nintedanib in Plasma at steady-state at day 29"},{"outcome_type":"secondary","measure":"Unconfirmed Best Overall Response","time_frame":"Baseline until end of treatment, up to 991 days","description":"Unconfirmed best overall response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0).\r\nPD = Progressive disease."},{"outcome_type":"secondary","measure":"Unconfirmed Best Objective Response","time_frame":"Baseline until end of treatment, up to 991 days","description":"Unconfirmed best objective response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0)"},{"outcome_type":"secondary","measure":"Clinical Benefit","time_frame":"Baseline until end of treatment, up to 991 days","description":"Clinical benefit was defined as the absence of disease progression (no PD or nonevaluable clinically progressive disease) determined by RECIST (version 1.0)."},{"outcome_type":"secondary","measure":"Confirmed Objective Response","time_frame":"Baseline until end of treatment, up to 991 days","description":"Confirmed objective response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0)"},{"outcome_type":"secondary","measure":"Progression Free Survival","time_frame":"First drug administration (in previous trial) until end of treatment, up to 1230 days","description":"Percentage of participants that experienced progression free survival (PFS), assessed by RECIST (Response Evaluation Criteria In Solid Tumours) (version 1.0), by day 1230. Progression was defined as progressive disease (PD) or non-evaluable clinically progressive disease.\r\nPFS was defined for patients without PD at screening as the time from first treatment with the trial drug in the previous trial until onset of PD or death, whatever comes earlier.\r\nPatients with PD could enter the trial if they showed signs of clinical benefit. For patients with PD at screening, the RECIST assessment at screening was used as a new baseline value and PFS was the time from first treatment with the trial drug in this trial until the onset of progressive disease in this trial or death, whatever comes first."}]}
{"nct_id":"NCT00087490","start_date":"2004-10-31","phase":"Phase 4","enrollment":1077,"brief_title":"Skin Structure Infections With Suspected or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)","official_title":"Linezolid in the Treatment of Subjects With Complicated Skin and Soft Tissue Infections Proven to be Due to Methicillin-Resistant Staphylococcus Aureus","primary_completion_date":"2007-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-07-31","last_update":"2012-08-08","description":"To determine if linezolid is superior to vancomycin in the treatment of complicated skin and soft tissue infections due to MRSA in adult subjects","other_id":"A5951002","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male and female subjects with signs or symptoms consistent with infection, and if\r\n             available, laboratory findings consistent with staphylococcal infection (e.g., Gram\r\n             stain and culture results).\r\n\r\n          -  Signs and symptoms consistent with infection\r\n\r\n          -  Infection suspected to be due to Methicillin Resistant Staphylococcus Aureus\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subjects who were treated with a previous antibiotic (systemic or topical) with MRSA\r\n             activity (other than linezolid or vancomycin) for more than 24 hours and treatment\r\n             extended into the 72 hour period prior to the first dose of study drug, unless\r\n             documented to be a treatment failure (72 hours of treatment and not responding).\r\n\r\n          -  Subjects with uncomplicated skin or superficial skin structure infection such as\r\n             superficial/simple cellulitis, impetiginous lesion, furuncle, or simple abscess that\r\n             only need surgical drainage for cure.\r\n\r\n          -  Subjects excluded with necrotizing fasciitis, gas gangrene, osteomyelitis\r\n      ","sponsor":"Pfizer","sponsor_type":"Industry","conditions":"Skin/Soft Tissue Infections|Methicillin Resistant Staphylococcus Aureus (MRSA)","interventions":[{"intervention_type":"Drug","name":"Drug: linezolid"},{"intervention_type":"Drug","name":"Drug: vancomycin"}],"outcomes":[{"outcome_type":"primary","measure":"Clinical Outcome in Participants With Baseline Methicillin-Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for Per-Protocol (PP) Population","time_frame":"EOS (6 to 28 days after the last dose of study drug)","description":"Clinical response (CR) was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At EOS, CR was evaluated as \"success\" (cure: resolution of clinical signs or (/) symptoms of infection when compared to baseline); \"failure\": persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; \"unknown\": extenuating circumstances precluding classification to 1 of above. \"Unknown\" was excluded from present analysis."},{"outcome_type":"secondary","measure":"Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population","time_frame":"EOT (within 72 hours of last dose of study drug)","description":"CR evaluated at EOT visit as \"success\" (cure: resolution of clinical sign/symptoms of infection when compared with baseline; and improvement: 2/more improvement in clinical sign/symptoms of infection when compared with baseline); \"failure\": persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; \"unknown\": extenuating circumstances precluding classification to 1 of above. \"Unknown\": excluded from present analysis."},{"outcome_type":"secondary","measure":"Clinical Outcome in Participants With Baseline MRSA at EOS for Modified-Intent to Treat (mITT) Population","time_frame":"EOS (6 to 28 days after the last dose of study drug)","description":"CR was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At EOS, CR was evaluated as \"success\" (cure: resolution of clinical signs/symptoms of infection when compared to baseline); \"failure\": persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; \"unknown\": extenuating circumstances precluding classification to 1 of above. \"Unknown\" was excluded from present analysis."},{"outcome_type":"secondary","measure":"Clinical Outcome in Participants With Baseline MRSA at EOT for mITT Population","time_frame":"EOT (within 72 hours of last dose of study drug)","description":"CR evaluated at EOT visit as \"success\" (cure: resolution of clinical sign/symptoms of infection when compared with baseline; and improvement: 2/more improvement in clinical sign/symptoms of infection when compared with baseline); \"failure\": persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; \"unknown\": extenuating circumstances precluding classification to 1 of above. \"Unknown\": excluded from present analysis."},{"outcome_type":"secondary","measure":"Microbiological Outcome in Participants With Baseline MRSA at EOS for PP Population","time_frame":"EOS (6 to 28 days after the last dose of study drug)","description":"Microbiological outcome dichotomized to \"success\" (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and \"failure\" (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture; recurrence: presence of isolate at EOS, that was eradicated at EOT)."},{"outcome_type":"secondary","measure":"Microbiological Outcome in Participants With Baseline MRSA at EOT for PP Population","time_frame":"EOT (within 72 hours of last dose of study drug)","description":"Microbiological outcome dichotomized to \"success\" (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and \"failure\" (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture)."},{"outcome_type":"secondary","measure":"Microbiological Outcome in Participants With Baseline MRSA at EOS for mITT Population","time_frame":"EOS (6 to 28 days after the last dose of study drug)","description":"Microbiological outcome dichotomized to \"success\" (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and \"failure\" (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture; recurrence: presence of isolate at EOS, that was eradicated at EOT)."},{"outcome_type":"secondary","measure":"Microbiological Outcome in Participants With Baseline MRSA at EOT for mITT Population","time_frame":"EOT (within 72 hours of last dose of study drug)","description":"Microbiological outcome dichotomized to \"success\" (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and \"failure\" (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture)."},{"outcome_type":"secondary","measure":"Number of Participants With Clinical Signs and Symptoms at EOT and EOS for PP Population","time_frame":"EOT (within 72 hours of last dose of study drug), EOS (6 to 28 days after the last dose of study drug)","description":"Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms of an active skin or soft tissue infection caused by suspected MRSA included purulent discharge, nonpurulent discharge, erythema, swelling, induration, tenderness, pain and local skin warmth. It was recorded by the sponsor using wound parameter score ranging from 0 to 3; \"0= none, 1= mild, 2= moderate and 3= severe\"."},{"outcome_type":"secondary","measure":"Number of Participants With Clinical Signs and Symptoms at EOT and EOS for mITT Population","time_frame":"EOT (within 72 hours of last dose of study drug), EOS (6 to 28 days after the last dose of study drug)","description":"Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms of an active skin or soft tissue infection caused by suspected MRSA included purulent discharge, nonpurulent discharge, erythema, swelling, induration, tenderness, pain and local skin warmth. It was recorded using wound parameter score ranging from 0 to 3; \"0= none, 1= mild, 2= moderate and 3= severe\"."},{"outcome_type":"secondary","measure":"Duration of Hospital Stay for PP Population","time_frame":"Baseline up to EOS (6 to 28 days after the last dose of study drug)","description":"Duration of Hospital Stay was defined as the number of days the participant was cared as an inpatient in the hospital during the maximum 34 days of the study period. The number of days in the hospital was counted from start of study medication to date of discharge or last date known to be in the hospital (for missing discharge dates and participants who died) or Day 34 for participants who continued hospitalization beyond EOS period."},{"outcome_type":"secondary","measure":"Duration of Hospital Stay for mITT Population","time_frame":"Baseline up to EOS (6 to 28 days after the last dose of study drug)","description":"Duration of Hospital Stay was defined as the number of days the participant was cared as an inpatient in the hospital during the maximum 34 days of the study period. The number of days in the hospital was counted from start of study medication to date of discharge or last date known to be in the hospital (for missing discharge dates and participants who died) or Day 34 for participants who continued hospitalization beyond EOS period."},{"outcome_type":"secondary","measure":"Duration of Intravenous Therapy for PP Population","time_frame":"Baseline up to EOS (6 to 28 days after the last dose of study drug)","description":"Duration of intravenous antibiotic treatment was measured as the number of days intravenous doses of study medication was administered, before and after discharge."},{"outcome_type":"secondary","measure":"Duration of Intravenous Therapy for mITT Population","time_frame":"Baseline up to EOS (6 to 28 days after the last dose of study drug)","description":"Duration of intravenous antibiotic treatment was measured as the number of days intravenous doses of study medication was administered, before and after discharge."},{"outcome_type":"secondary","measure":"Number of Participants Using Medical Resources","time_frame":"Baseline up to EOS (6 to 28 days after the last dose of study drug)","description":"Medical resources utilization included a daily log of the participants' location in the hospital and outside of the hospital (non-hospital location), adjusted duration of stay (difference between duration of stay and the duration of discharge delay) and daily log of study drug dosing."}]}
{"nct_id":"NCT00435643","start_date":"2004-10-31","phase":"N/A","enrollment":45,"brief_title":"Influence of nCPAP on Metabolic Consequences Associated With OSAS","official_title":"Improvement in Hypothalamic-Pituitary-Adrenal Axis Function After Continuous Positive Airway Pressure Therapy in Obstructive Sleep Apnea Syndrome","study_type":"Interventional","rec_status":"Completed","completion_date":"2006-03-31","last_update":"2007-11-20","description":"Context: Obstructive sleep apnea syndrome (OSAS) is associated with cardiovascular morbidity. Recurrent episodes of occlusion of upper airways during sleep result in hormonal changes that may predispose to high cardiovascular risk.These risks can rapidly be reduced by effective nasal continuous positive airway pressure (nCPAP) therapy Objective: To evaluate hypothalamic pituitary adrenal axis, insulin resistance, blood pressure values and adipokines in severe obese patients with and without OSAS and to determine if continuous positive airway pressure therapy (nCPAP) influenced responses.","other_id":"12383","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Basic Science","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Aged from 18 to 65 years\r\n\r\n          -  Body mass index between 35-60 who were submitted to polysomnography\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of smoking\r\n\r\n          -  Sleep apnea treatment\r\n\r\n          -  Cardiovascular disease\r\n\r\n          -  Malignancies tumor\r\n\r\n          -  Thyroid disorders\r\n\r\n          -  Depression\r\n\r\n          -  Subjects with known diabetes mellitus on medications\r\n\r\n          -  Chronic renal or hepatic failure\r\n\r\n          -  On hormonal replacement therapy, as well as use of medication that could potentially\r\n             affect steroid hormone or cytokines secretion (alcohol, psychotropics, steroids,\r\n             sympathomimetics, beta-blockers).\r\n      ","sponsor":"Federal University of So Paulo","sponsor_type":"Other","conditions":"Obstructive Sleep Apnea Syndrome|Obesity","interventions":[{"intervention_type":"Procedure","name":"Procedure: nasal continuous positive airway pressure","description":"After an average interval of three months, 10 patients with severe OSAS (AHI of more than 30 events per hour of sleep) treated with a mean nCPAP pressure of 11.2  0.7 cm of H2O were reassessed and all mentioned measurements above were repeated"}],"outcomes":[{"outcome_type":"primary","measure":"To explore the interactive mechanisms of HPA axis, sympathetic nervous system activation, inflammatory cytokines, insulin resistance and hypertension in patients with and without sleep apnea, excluding the interference of the degree of fat accumulation.","time_frame":"one day"},{"outcome_type":"secondary","measure":"To evaluate low-dose dexamethasone-induced cortisol suppression and circadian rhythm of cortisol secretion in severe obese patients with sleep apnea in response to treatment with continuous positive airway pressure.","time_frame":"three months"}]}
{"nct_id":"NCT00287118","start_date":"2004-10-27","phase":"Phase 4","enrollment":189,"brief_title":"A Multicentre, Open Label Phase IIIb/IV Study of Subcutaneously Administered Raptiva in the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis","official_title":"A Multicentre, Open Label Phase IIIb/IV Study of Subcutaneously Administered Raptiva in the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis","primary_completion_date":"2006-05-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2006-05-30","last_update":"2018-04-03","description":"An open-label, multi-center study to establish psoriasis control of moderate to severe plaque psoriasis with Raptiva therapy administered subcutaneously for 24 weeks.","other_id":"25161","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":17,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  A) In the opinion of the investigator, candidate for systemic therapy for psoriasis\r\n             could include:\r\n\r\n          -  Patients with moderate to severe plaque psoriasis defined by Psoriasis Area and\r\n             Severity Index (PASI) less than (>) 10 and body surface area (BSA) greater than (>) 10\r\n\r\n          -  Patients with the following may also be deemed to require systemic therapy in the\r\n             judgement of the physician:\r\n\r\n          -  Severe psychosocial disability (in the judgement of the physician), or\r\n\r\n          -  Nail psoriasis, or\r\n\r\n          -  Scalp psoriasis, or\r\n\r\n          -  Palmar plantar psoriasis etc OR\r\n\r\n          -  B) Subjects who have completed the CLEAR study investigational medicinal product (IMP)\r\n             24011 (NCT00256139) and who wish to continue Raptiva (efalizumab) therapy.\r\n\r\n          -  Body weight of 120 kg\r\n\r\n          -  18 to 75 years old\r\n\r\n          -  For women of childbearing potential and for men whose partner can become pregnant, use\r\n             of an acceptable method of contraception to prevent pregnancy and agreement to\r\n             continue to practice an acceptable method of contraception for the duration of their\r\n             participation in the study up to 3 months after the last dose of Raptiva\r\n\r\n          -  Willingness to hold sun exposure reasonably constant and to avoid use of tanning\r\n             booths or other ultraviolet (UV) light sources during the study\r\n\r\n          -  Agreement to participate in the study\r\n\r\n          -  Signed informed consent\r\n\r\n          -  Discontinuation of any systemic psoriasis treatment prior to commencement of the study\r\n             drug. No washout period is required for these agents prior to starting study and\r\n             receiving first dose of study drug (Raptiva)\r\n\r\n          -  Discontinuation of all biologic agents (other than Raptiva) 3 months prior to\r\n             receiving first dose of study drug (Raptiva)\r\n\r\n          -  Discontinuation of Psoralen-ultraviolet light A (PUVA), Ultraviolet light B (UVB)\r\n             treatment 28 days prior to commencement of receiving first dose of study drug.\r\n\r\n          -  Discontinuation of any investigational drug or treatment 3 months prior to study Day 0\r\n             or as per washout requirements from previous protocol\r\n\r\n          -  No vaccinations (e.g., tetanus, booster, influenza vaccine) at least 14 days prior to\r\n             first dose of study drug\r\n\r\n          -  Treatment regimens of b-blockers, Angiotensin-converting enzyme (ACE) inhibitors,\r\n             antimalarial drugs, quinidine, interferon, or lithium stable for at least 28 days\r\n             prior to first dose of study drug\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis\r\n\r\n          -  Active rebound of psoriasis during or following discontinuation of the previous\r\n             Raptiva treatment( PASI >125% from baseline and/or new predominant morphology of\r\n             psoriasis) when reason was adverse event or lack of efficacy of Raptiva. If it was due\r\n             to another non drug reason (vaccination, or infection) then the patient can be\r\n             included in this study.\r\n\r\n          -  History of severe allergic or anaphylactic reactions to humanised monoclonal\r\n             antibodies\r\n\r\n          -  History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial\r\n             infection\r\n\r\n          -  History of opportunistic infections (e.g., systemic fungal infections, parasites)\r\n\r\n          -  Seropositivity for human immunodeficiency virus (HIV). Patients will undergo mandatory\r\n             testing at screening. Patients who are positive for HIV will be excluded.\r\n\r\n          -  Pregnancy or lactation\r\n\r\n          -  White blood cell (WBC) count <4000 per Liter (L) or >14,000/L\r\n\r\n          -  Patient with a history of clinically significant thrombocytopenia, bleeding disorders\r\n             or a platelet count < 00,000 cells/L\r\n\r\n          -  Seropositivity for hepatitis B or C virus Patients will undergo testing at screening.\r\n             Patients who are positive for hepatitis B antigen or hepatitis C antibody will be\r\n             excluded.\r\n\r\n          -  Hepatic enzymes >3 times the upper limit of normal\r\n\r\n          -  History of active tuberculosis (TB) or currently undergoing treatment for TB within\r\n             one year prior to study Day 0. Chest X-ray (within 3 months prior to Study Day 0) is\r\n             required for high-risk patients. Patients with a positive chest X-ray will be\r\n             excluded.\r\n\r\n          -  Presence of malignancy within the past 5 years, including lymphoproliferative\r\n             disorders. Patients with a history of fully resolved basal cell or squamous cell skin\r\n             cancer may be enrolled.\r\n\r\n          -  Diagnosis of hepatic cirrhosis, regardless of cause or severity\r\n\r\n          -  Serum creatinine >2 times the upper limit of normal\r\n\r\n          -  Hospital admission for cardiac disease, stroke, or pulmonary disease within the last\r\n             year\r\n\r\n          -  History of substance abuse within the last 5 years\r\n\r\n          -  Any medical condition that, in the judgment of the investigator, would jeopardize the\r\n             patient's safety following exposure to study drug\r\n      ","sponsor":"Merck KGaA, Darmstadt, Germany","sponsor_type":"Industry","conditions":"Candidates for Systemic Therapy for Psoriasis|Psoriasis","interventions":[{"intervention_type":"Drug","name":"Drug: Efalizumab","description":"Subjects will receive a conditioning dose of 0.7 milligram per kilogram (mg/kg) efalizumab subcutaneously on study Day 0 followed by 1.0 mg/kg efalizumab subcutaneously once a week for 23 weeks."}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of Subjects With Physician's Global Assessment (PGA) Ratings of \"Excellent\" or \"Cleared\" at Week 24","time_frame":"Week 24","description":"The PGA rating was used to assess the global response of all psoriatic lesions by comparing subject's present condition to baseline photographs or body diagrams. The response was classified as Cleared: 100% improvement of all clinical signs and symptoms compared to baseline; Excellent: 75% to 99% improvement of all signs and symptoms compared to baseline; Good: 50% to 74% improvement of signs and symptoms compared to baseline; Fair: 25% to 49% improvement of signs and symptoms compared to baseline; Slight: 1% to 24% improvement of signs and symptoms compared to baseline; Unchanged: Clinical signs and symptoms unchanged from baseline and Worse: Clinical signs and symptoms deteriorated from baseline."}]}
{"nct_id":"NCT00946387","start_date":"2004-09-30","phase":"Phase 1","enrollment":26,"brief_title":"To Demonstrate the Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Fasting Conditions","official_title":"A Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Fasting Conditions","primary_completion_date":"2004-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2004-09-30","last_update":"2017-03-28","description":"To demonstrate the relative bioavailability study of Ondansetron HCl 24 mg tablets under fasting conditions.","other_id":"B043712","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":22,"maximum_age":58,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  No clinically significant abnormal finding on physical exam, medical history, or\r\n             clinical laboratory results on screening.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Positive test results for HIV or hepatitis B or C.\r\n\r\n          -  Treatment for drug or alcohol dependence.\r\n      ","sponsor":"Sandoz","sponsor_type":"Industry","conditions":"Nausea|Vomiting","interventions":[{"intervention_type":"Drug","name":"Drug: Ondansetron HCl 24 mg Tablets (Sandoz, Inc.)"},{"intervention_type":"Drug","name":"Drug: Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline)"}],"outcomes":[{"outcome_type":"primary","measure":"Bioequivalence based on AUC and Cmax","time_frame":"9 days"}]}
{"nct_id":"NCT00159679","start_date":"2004-09-30","phase":"Phase 4","enrollment":167,"brief_title":"Pregabalin in the Treatment of Pain Due to Diabetic Peripheral Neuropathy","official_title":"A 13 Week, Double-Blind, Placebo-Controlled Phase 4 Trial of Pregabalin (CI-1008, 600 mg/Day) for Relief of Pain in Subjects With Painful Diabetic Peripheral Neuropathy","study_type":"Interventional","rec_status":"Completed","completion_date":"2005-10-31","last_update":"2021-01-25","description":"The purposes of this study are to: 1) find out if pregabalin relieves pain in subjects with painful diabetic peripheral neuropathy; 2) find out if pregabalin is safe at a dose of 600 mg/day (taken twice a day); and 3) find out if changes in nerve function happen during the study.","other_id":"A0081060","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adults with Type 1 or 2 diabetes\r\n\r\n          -  Patients must have pain in their lower legs or feet due to painful diabetic neuropathy\r\n             that has lasted for at least 3 months\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients must not be in poor or unstable health.\r\n      ","sponsor":"Pfizer's Upjohn has merged with Mylan to form Viatris Inc.","sponsor_type":"Industry","conditions":"Diabetic Neuropathy, Painful","interventions":[{"intervention_type":"Drug","name":"Drug: Pregabalin"}],"outcomes":[{"outcome_type":"primary","measure":"Nerve conduction measurements; Pain scores from patient diaries"},{"outcome_type":"secondary","measure":"Proportion of patients with at least a 50% reduction in pain scores; Short-Form McGill Pain Questionnaire; Sleep interference scores from patient diaries; Clinical Global Impression of Change; Patient Global Impression of Change"}]}
{"nct_id":"NCT01415375","start_date":"2004-09-30","phase":"Phase 2/Phase 3","enrollment":490,"brief_title":"Prostate Cancer Education in African American Men","official_title":"Prostate Cancer Education in African American Men","primary_completion_date":"2007-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-07-31","last_update":"2015-04-17","description":"This study evaluates the efficacy of a tailored telephone intervention to promote informed decision making about prostate cancer testing among predominantly immigrant black men.","other_id":"R01CA104223","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Screening","masking_description":"Single","sampling_method":"","gender":"Male","minimum_age":45,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  45 to 70 year old\r\n\r\n          -  African descent\r\n\r\n          -  accessible by telephone\r\n\r\n          -  have primary care physician\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prostate cancer test in 12 months prior to enrollment\r\n\r\n          -  History of prostate cancer\r\n      ","sponsor":"Temple University","sponsor_type":"Other","conditions":"Prostate Cancer Screening Decision","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Prostate Cancer Screening Education","description":"tailored telephone education on prostate cancer testing"},{"intervention_type":"Behavioral","name":"Behavioral: Fruit and Vegetable Intake Education","description":"tailored telephone education about fruit and vegetable consumption"}],"outcomes":[{"outcome_type":"primary","measure":"congruence between prostate cancer testing intention and behavior","time_frame":"1 and 2 years post randomization","description":"Congruence between men's stated intentions to get tested and their actual testing behavior, validated by medical claims at 1 and 2 year follow-up. Intention-behavior agreement was coded as congruent (1), whereas disagreement was coded as incongruent (0)."},{"outcome_type":"primary","measure":"Knowledge about prostate cancer and prostate cancer tests","time_frame":"baseline and 8 months post randomization","description":"12 item knowledge index with questions on testing, risk factors and epidemiology, and treatment effectiveness and side effects. Percent correct was used as the outcome measure."},{"outcome_type":"primary","measure":"Decisional conflict","time_frame":"8 months post randomization","description":"Used a modified version of the 16 item Decisional Conflict Scale with the 3 level response category suggested for low literacy populations."},{"outcome_type":"primary","measure":"Verified doctor visit to discuss prostate cancer testing","time_frame":"2 years post randomization","description":"Visit with physician to talk about prostate cancer testing, with visit verified through medical claims records"},{"outcome_type":"secondary","measure":"State anxiety","time_frame":"baseline and 8 months post-randomization","description":"Used a 7 item subscale of the Hospital Anxiety and Depression Scale."}]}
{"nct_id":"NCT00232531","start_date":"2004-09-30","phase":"N/A","enrollment":70,"brief_title":"Oxford Niaspan Study: Effects of Niaspan on Atherosclerosis and Endothelial Function","official_title":"Cardiovascular Magnetic Resonance Evaluation of the Effects of Niaspan on Regression of Atherosclerosis and Restoration of Endothelial Function","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2009-02-28","last_update":"2007-01-29","description":"AIM 1 will test the hypothesis that elevation of high-density lipoprotein (HDL) through treatment with Niaspan will accelerate the regression of atherosclerotic plaque in patients with established atherosclerosis. The investigators will therefore study patients with atherosclerosis in the aorta and carotid artery. Plaque quantification will be with magnetic resonance imaging (MRI). AIM 2 will assess the ability of Niaspan to improve endothelial function in patients with coronary artery disease and type II diabetes mellitus, who typically have low high-density lipoprotein cholesterol (HDL-C), and high risk of cardiovascular events.","other_id":"04.OXA.020","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Aim 1: Carotid or peripheral arterial disease and HDL <1mmol/L\r\n\r\n          -  Aim 2: Coronary artery disease, type II diabetes and HDL <1mmol/L\r\n\r\n        Exclusion Criteria:\r\n\r\n        The following will constitute exclusion criteria:\r\n\r\n          -  Inability to provide informed consent,\r\n\r\n          -  Known intolerance of a study drug,\r\n\r\n          -  Use of niacin or a fibrate at time of screening,\r\n\r\n          -  AST or ALT elevated above normal range at time of screening\r\n\r\n          -  Use of oral nitrates or nicorandil\r\n\r\n          -  Uncontrolled or newly diagnosed diabetes mellitus\r\n\r\n          -  Symptomatic heart failure or heart failure requiring treatment with diuretics\r\n\r\n          -  Fasting triglycerides > 500mg/dL [5.65mmol/L]\r\n\r\n          -  Patients with acute coronary syndromes, active peptic ulcer disease,\r\n\r\n          -  Active gout,\r\n\r\n          -  Standard exclusions for MRI will apply, i.e. pacemakers, implantable defibrillators,\r\n             metal implants or embedded metallic fragments of any kind.\r\n      ","sponsor":"University of Oxford","sponsor_type":"Other","conditions":"Atherosclerosis","interventions":[{"intervention_type":"Drug","name":"Drug: Niaspan"}],"outcomes":[{"outcome_type":"primary","measure":"Regression of artheriosclerotic plaque measured using functional magnetic resonance imaging."}]}
{"nct_id":"NCT00271089","start_date":"2004-08-31","phase":"N/A","enrollment":40,"brief_title":"Blood Cell Collection for Future Use in Individuals With Fanconi Anemia","official_title":"Collection of Hematopoietic Cells From Patients With Fanconi Anemia (FA) for Future Autologous Reinfusion and Research","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-10-31","last_update":"2016-07-12","description":"Fanconi anemia (FA) is a disease that affects an individual's bone marrow. It is caused by a defective gene in the CD34+ cells, which are responsible for producing various types of blood cells. Individuals with FA may experience fatigue, bleeding, and increased infections. The purpose of this study is to collect and purify blood cells from individuals with FA and store them for future therapeutic use.","other_id":"378","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":1,"maximum_age":35,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosis of FA\r\n\r\n          -  Normal bone marrow cytogenetics within 3 months of study entry\r\n\r\n          -  Absolute neutrophil count (ANC) level greater than 750\r\n\r\n          -  Hemoglobin level greater than 8 without transfusion\r\n\r\n          -  Platelet level greater than 30,000 without transfusion\r\n\r\n          -  Must weigh at least 7.5 kg\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Myloid or lymphoid leukemia\r\n\r\n          -  Cytogenic abnormalities\r\n\r\n          -  HIV infected\r\n\r\n          -  Neoplastic or non-neoplastic disease of any major organ system that would compromise\r\n             the ability to withstand the collection procedure\r\n\r\n          -  Uncontrolled infection\r\n\r\n          -  Unable to tolerate general anesthesia\r\n\r\n          -  Known adverse reaction to E. Coli\r\n\r\n          -  Pregnant or breastfeeding\r\n      ","sponsor":"National Heart, Lung, and Blood Institute (NHLBI)","sponsor_type":"NIH","conditions":"Fanconi Anemia","interventions":[{"intervention_type":"Procedure","name":"Procedure: PBSC Collection"},{"intervention_type":"Procedure","name":"Procedure: Bone Marrow Harvest"},{"intervention_type":"Device","name":"Device: CliniMacs Cell Selection System"}],"outcomes":[{"outcome_type":"primary","measure":"CD34+ cell collection"}]}
{"nct_id":"NCT00797901","start_date":"2004-08-31","phase":"N/A","enrollment":179,"brief_title":"Depression Treatment in General Medical Settings","official_title":"Depression Treatment in General Medical Settings","primary_completion_date":"2008-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-04-30","last_update":"2014-08-28","description":"The purpose of this study was to examine the effect of a new disease management model for depression, the Collaborative Depression Management Program (CDMP), designed to improve clinical outcomes and increase depression treatment in general medical settings.","other_id":"S06GM008224","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  patients ages 18 or older that meet the clinical criteria for major depression.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  pregnancy, planning a pregnancy, breastfeeding or less than 3 months post-partum\r\n\r\n          -  severe cognitive impairment\r\n\r\n          -  ongoing psychiatric treatment\r\n\r\n          -  do not plan to use the study clinic as a main source of medical care during the next\r\n             six months\r\n\r\n          -  a history of bipolar disorder or psychosis\r\n\r\n          -  those clinically judged to have a high acute suicidal risk\r\n\r\n          -  unstable or life-threatening medical condition\r\n      ","sponsor":"University of Puerto Rico","sponsor_type":"Other","conditions":"Major Depression","interventions":[{"intervention_type":"Other","name":"Other: Collaborative Care"}],"outcomes":[{"outcome_type":"primary","measure":"Depression","time_frame":"2 months"},{"outcome_type":"primary","measure":"Health-Related Functional Impairment","time_frame":"2 months"},{"outcome_type":"primary","measure":"Quality of Life","time_frame":"2 months"},{"outcome_type":"secondary","measure":"Satisfaction with Care","time_frame":"2 months"},{"outcome_type":"secondary","measure":"Barriers to Treatment","time_frame":"2 months"}]}
{"nct_id":"NCT00873028","start_date":"2004-08-31","phase":"Phase 3","enrollment":20,"brief_title":"Evaluation of Inspiratory Muscle Strength Early After Coronary Artery Bypass","official_title":"Inspiratory Muscle Strength as a Determinant of Functional Capacity Early After Coronary Artery Bypass Graft Surgery","primary_completion_date":"2006-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2006-01-31","last_update":"2009-04-01","description":"The purpose of this study is to evaluate the effects of a 6-day postoperative in hospital cardiopulmonary rehabilitation program on inspiratory muscle strength and its potential association with improved functional capacity after coronary artery bypass grafting surgery.","other_id":"P1CRh","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":21,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Previous history of more than one vessel coronary artery disease\r\n\r\n          -  Lifelong abstinence from tobacco\r\n\r\n          -  Formal indication for CABG\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients older than 75 years of age\r\n\r\n          -  Chronic renal failure (dialysis for more than 3 months)\r\n\r\n          -  Unstable angina in the 48 hours prior to CABG\r\n\r\n          -  Moderate or severe valve disease\r\n\r\n          -  Complex cardiac arrhythmia's\r\n\r\n          -  Stroke\r\n\r\n          -  Inability to exercise the lower limbs\r\n\r\n          -  Previous pulmonary disease (forced vital capacity [FVC] < 80% of predicted and/or\r\n             forced expiratory volume in 1 s [FEV1] < 70% of predicted)\r\n\r\n          -  Previous history of asthma.\r\n      ","sponsor":"Hospital de Clinicas de Porto Alegre","sponsor_type":"Other","conditions":"Coronary Artery Disease","interventions":[{"intervention_type":"Other","name":"Other: In Hospital Cardiopulmonary Rehabilitation","description":"The program consisted of bronchial hygiene characterized by detachment and removal of secretions and respiratory exercises which were applied in the respiratory muscles in order to strengthen and increase the resistance. Patients were instructed to maintain diaphragmatic breathing, at a rate of 12 to 18 breaths per minute during EPAP mask use, and the expiratory pressure was increased progressively in the following fashion: 3-8 cm H2O during 3-12 minutes. Also, they performed flexion/extension of hip and knee, active free exercises for upper limbs, ambulation exercise and ascent/descend of stairs"}],"outcomes":[{"outcome_type":"primary","measure":"Maximal inspiratory and expiratory pressure were measured (before, 7 and 30 days after surgery).","time_frame":"From 1 day before surgery up to 30 days after surgery (CABG)"},{"outcome_type":"secondary","measure":"Six-minute walk test (6MWT) was performed 7 days after surgery, and maximal cardiopulmonary exercise testing (CPET) was performed 30 days after CABG.","time_frame":"From 7 days after surgery up to 30 days after surgery (CABG)"}]}
{"nct_id":"NCT00402155","start_date":"2004-07-31","enrollment":100,"brief_title":"Visual Discomfort and Reading","official_title":"Visual Discomfort and Reading","study_type":"Observational","rec_status":"Completed","completion_date":"2008-12-31","last_update":"2009-11-13","description":"Reading can be an uncomfortable and difficult task for some people. Symptoms include unpleasant somatic and perceptual effects, such as eye-strain, headache, and blurred text, despite normal visual acuity. This condition has been called Visual Discomfort, but little is known about the symptoms and frequency of reading problems associated with this disorder. Several studies have proposed that Visual Discomfort is caused by increased noise in the visual system due to spreading cortical activation across different spatial frequency channels. This study examines the prevalence and severity of visual discomfort in a college student population and tests the noisy visual system hypothesis.","other_id":"SCCO2-2218","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":17,"maximum_age":30,"population":"Subjects will be chosen from the student population and Claremont McKenna College.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  normal College age subjects with low visual discomfort scores on the Conlon visual\r\n             discomfort survey.\r\n\r\n          -  normal College age subjects with high visual discomfort scores on the Conlon visual\r\n             discomfort survey.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  English as a second language, uncorrected visual defects, reading disabilities,\r\n             medical conditions that might cause uncomfortable visual symptoms, strabismus,\r\n             stereopsis less than 70 seconds of arc, any ocular pathology, color vision deficiency,\r\n             IQ less than 90.\r\n      ","sponsor":"Southern California College of Optometry at Marshall B. Ketchum University","sponsor_type":"Other","conditions":"Visual Fatigue","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Stress on visual discomfort","description":"Effects of visual discomfort are measured by contrast sensitivity, ERGs, and accommodative stability."}],"outcomes":{}}
{"nct_id":"NCT00591708","start_date":"2004-07-31","phase":"N/A","enrollment":34,"brief_title":"Calcium Metabolism in Asian Adolescents","official_title":"Calcium Metabolism in Asian Adolescents","primary_completion_date":"2005-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2005-08-31","last_update":"2018-05-09","description":"Maximizing calcium retention by the skeleton within the genetic potential is a key strategy to prevent osteoporosis. It has been shown that calcium retention varies between blacks and whites and between gender within race. This study is designed to study the relationship between calcium intakes and calcium retention in Asian adolescent girls and boys. It is hypothesized that calcium intakes which maximize calcium retention will be lower in Asians than for whites studies under the same conditions. In addition it is thought that the differences between races in the physiological mechanisms involved in calcium metabolism will result in a lower calcium intake required to observe a plateau in calcium retention. This is turn could be translated into lower calcium requirements in Asians relative to Caucasians for achieving optimal peak bone mass.","other_id":"AR40553","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Prevention","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":11,"maximum_age":15,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  healthy teens of Asian descent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  malabsorptive disorders\r\n\r\n          -  anemia\r\n\r\n          -  smoking, illegal drugs\r\n\r\n          -  oral contraceptives\r\n\r\n          -  pregnancy\r\n\r\n          -  drugs that influence calcium metabolism\r\n\r\n          -  body weight for height greater than 85 percentile\r\n      ","sponsor":"Purdue University","sponsor_type":"Other","conditions":"Bone Mineralization|Adolescent Development","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Beverage containing calcium citrate malate","description":"Beverages containing a lower amount of calcium (0-400 mg/d) will be supplemented to a basal diet containing 600 mg/d Ca. The controlled diet will be consumed for 21 consecutive days."},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: Beverage fortified with calcium citrate malate","description":"Beverages containing a higher amount of calcium (500-1300 mg/d) will be supplemented to a basal diet containing 600 mg/d Ca. The controlled diet will be consumed for 21 consecutive days."}],"outcomes":[{"outcome_type":"primary","measure":"Calcium retention (mg/d)","time_frame":"Metabolic balance will be determined over a two week period on a controlled diet after equilibration for one week on the same diet."},{"outcome_type":"secondary","measure":"Serial serum biochemistry profiles (PTH, 1,25 dihydroxy-vitamin D, calcium)","time_frame":"Six serial measurements in 10 hours after ingestion of a calcium load representing one third of the daily consumption"}]}
{"nct_id":"NCT00210782","start_date":"2004-06-30","phase":"Phase 3","enrollment":262,"brief_title":"A Comparison of the Effectiveness and Safety of Topiramate and Phenytoin in Patients With New Onset Epilepsy Requiring Rapid Initiation of Antiepileptic Drug Treatment","official_title":"A Double-blind Trial Comparing the Efficacy, Tolerability and Safety of Monotherapy Topiramate Versus Phenytoin in Subjects With Seizures Indicative of New Onset Epilepsy","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-08-31","last_update":"2011-06-10","description":"The purpose of this study is to compare the effectiveness and safety of two treatment regimens, topiramate as compared to phenytoin, in preventing seizures in patients with new-onset epilepsy who require rapid initiation of antiepileptic drug therapy. Reasons for requiring rapid initiation of treatment, rather than slowly increasing an antiepileptic drug to an effective dose, may include severe or frequent seizures, or high risk to the patient of recurrent seizures.","other_id":"CR004663","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":12,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Seizures indicative of new-onset epilepsy (or epilepsy relapse) of untreated epilepsy\r\n\r\n          -  at least one but not more than 20 unprovoked seizures within past 3 months\r\n\r\n          -  weighing more than 110 pounds\r\n\r\n          -  considered to be a good candidate for rapid initiation of anti-seizure medication\r\n\r\n          -  able to swallow a tablet whole (without crushing it).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Not having taken anti-seizure medications within the past 30 days\r\n\r\n          -  no provoking factors for seizures (presence of alcohol withdrawal, drug intoxication,\r\n             acute meningitis or encephalitis, acute head injury or stroke, acute hypoxic/ischemic\r\n             encephalopathy, or brain tumor)\r\n\r\n          -  no presence of active liver disease or serious kidney disease\r\n\r\n          -  not pregnant or breast-feeding\r\n\r\n          -  not using birth control.\r\n      ","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","sponsor_type":"Industry","conditions":"Epilepsy","interventions":[{"intervention_type":"Drug","name":"Drug: topiramate, phenytoin"}],"outcomes":[{"outcome_type":"primary","measure":"The primary outcome parameter is the time to first seizure during the double blind phase of the study. The statistical evaluation will analyze if there is a significant difference in the proportion of patients being seizure free between both medications."},{"outcome_type":"secondary","measure":"Effect of sex, age, baseline weight, baseline seizure type, and duration since first diagnosis of epilepsy on the time to seizure."}]}
{"nct_id":"NCT00917241","start_date":"2004-06-30","phase":"Phase 4","enrollment":218,"brief_title":"Prevention Relapse of Graves' Disease by Intrathyroid Injection of Dexamethasone","official_title":"Prevention Relapse of Graves' Disease by Treatment With Intrathyroid Injection of Dexamethasone","primary_completion_date":"2008-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-03-31","last_update":"2013-05-06","description":"Antithyroid drugs are widely used in treatment of Graves' disease (GD), but after therapy withdrawal, relapse rate is very high. The aim this trail is to evaluate the effects of intrathyroid injection of dexamethasone combined with antithyroid drugs on patients with newly diagnosed GD.","other_id":"NanjingMU","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Newly diagnosed of Graves' Disease\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnancy\r\n\r\n          -  Allergy to ATD, Alanine aminotransferase (ALT) or asparate aminotransferase (AST)\r\n             above 2 times of upper normal range\r\n\r\n          -  Non-compliance because of psychiatric or other serious diseases, or unwillingness to\r\n             participate in the study.\r\n      ","sponsor":"Xiao-Ming Mao","sponsor_type":"Other","conditions":"Graves' Disease","interventions":[{"intervention_type":"Drug","name":"Drug: MMI combined with IID","description":"MMI titration regimen for 18 months,initial dosage of MMI was 20 mg/d,which combined with IID for 3 months.Dexamethasone was injected into the two side of thyroid, the dose of dexamethasone was 5 mg by every side, twice a week. The treatment strategy was changed to once a week at the second month and twice a month at the third month, the dose of dexamethasone was the same as the first month."},{"intervention_type":"Drug","name":"Drug: MMI","description":"MMI treatment with titration regimen for 18 months, initial dosage was 20 mg/d."}],"outcomes":[{"outcome_type":"primary","measure":"relapse of hyperthyroidism","time_frame":"4.5 year"}]}
{"nct_id":"NCT00194610","start_date":"2004-05-31","phase":"Phase 4","enrollment":20,"brief_title":"Botox as a Treatment for Interstitial Cystitis in Women","official_title":"Botox (Botulinum Toxin A) as a Treatment for Interstitial Cystitis in Women: A Randomized Placebo Controlled Trial","primary_completion_date":"2009-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-09-30","last_update":"2012-10-12","description":"Patients with interstitial cystitis have been well documented to have pelvic floor muscle tenderness as well as pain on bladder distension. Some investigators have even suggested that pelvic floor muscle pain is primarily the cause of bladder problems. Botulinum toxin A causes muscle relaxation by inhibiting the acetylcholine release at the neuromuscular junction. It has been shown that this mechanism relieves pain in a number of muscle spasm-related syndromes. Because, at present, there is little effective therapy available for patients with interstitial cystitis, the researchers want to determine if botulinum toxin A will relieve bladder and pelvic pain in these patients.","other_id":"25398-D","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Women ages 18 and older\r\n\r\n          -  Diagnosis of interstitial cystitis\r\n\r\n          -  Subject has severity/stage of disease: at least 12 voids/day with the presence of\r\n             pelvic pain\r\n\r\n          -  Ability to follow study instructions and likely to complete all required visits.\r\n\r\n          -  Negative urine pregnancy test on the day of treatment prior to the administration of\r\n             study medication (for females of childbearing potential; if applicable)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Use of any medications that might interfere with neuromuscular function\r\n\r\n          -  Any medical condition that may put the subject at increased risk with exposure to\r\n             Botox including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic\r\n             lateral sclerosis, or any other disorder that might interfere with neuromuscular\r\n             function\r\n\r\n          -  Females who are pregnant, breast-feeding, or planning a pregnancy during the study or\r\n             who think that they may be pregnant at the start of the study, or females of\r\n             childbearing potential who are unable or unwilling to use a reliable form of\r\n             contraception during the study\r\n\r\n          -  Known allergy or sensitivity to any of the components in the study medication\r\n\r\n          -  Concurrent participation in another investigational drug or device study, or\r\n             participation in the 30 days immediately prior to study enrollment.\r\n\r\n          -  Stress incontinence\r\n\r\n          -  Urinary tract infection at time of enrollment\r\n\r\n          -  Overtly psychotic or suicidal\r\n\r\n          -  Pain from another source in the genital tract such as kidney stones or neoplasm\r\n\r\n          -  Having had radiation therapy\r\n\r\n          -  History of genitourinary tuberculosis\r\n\r\n          -  Neurological abnormalities such as stroke, brain tumors, spinal cord injury and\r\n             Parkinson's or Alzheimer's disease\r\n\r\n          -  Currently taking antibiotics\r\n      ","sponsor":"University of Washington","sponsor_type":"Other","conditions":"Painful Bladder Syndrome|Interstitial Cystitis","interventions":[{"intervention_type":"Drug","name":"Drug: Botox","description":"Botox 25 international units per injection injected in two places in the bladder neck, with option to inject two other tender points with 25 units each"},{"intervention_type":"Other","name":"Other: normal saline","description":"Normal saline injected into the bladder neck via the perineum, 1 cc each given at positions 3 o'clock and 9 o'clock"}],"outcomes":[{"outcome_type":"primary","measure":"Chronic Prostatitis Symptom Index (CPSI-F)","time_frame":"3 months","description":"CPSI-F was adapted from the CPSI, in order to document the location of pain, with working pertinent to female anatomy. The CPSI-F was scored on a range of 0-83 (0-61 in the pain domain, 0-10 in the urination domain, 0-6 in the impact of symptoms domain, and 0-6 in the quality of life domain), with higher scores denoting worse symptoms."}]}
{"nct_id":"NCT00182208","start_date":"2004-05-31","phase":"Phase 3","enrollment":32,"brief_title":"Evaluation of a Venous-Return Assist Device (Venowave) to Treat Post-Thrombotic Syndrome: A Randomized Controlled Trial","official_title":"Evaluation of a Venous-Return Assist Device (Venowave) to Treat Post-Thrombotic Syndrome: A Randomized Controlled Trial","primary_completion_date":"2005-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2005-12-31","last_update":"2008-07-22","description":"The purpose of this study is to determine whether daily use of a lower limb venous-return assist device, \"Venowave', improves leg symptoms, ability to perform activities of daily living, and quality of life in subjects with severe PTS.","other_id":"CTMG-2005-VENOPTS","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Past History of objectively documented deep vein thrombosis\r\n\r\n          -  Daily leg swelling with discomfort (i.e. report at least one of the following\r\n             symptoms: heavy legs, aching legs and/or throbbing) for a minimum of 6 months\r\n\r\n          -  Over 18 years of age (and of either gender).\r\n\r\n          -  Villalta score of greater than 14(i.e.severe post phlebitic syndrome)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Episode of objectively documented deep vein thrombosis occurred less than 6 months\r\n             before recruitment\r\n\r\n          -  Subjects report that their symptoms have been unstable (worsening, improving or\r\n             variable over the previous month).\r\n\r\n          -  Active venous ulceration\r\n\r\n          -  Baseline leg circumference greater than 50 cm (cuff will not fit subject)\r\n\r\n          -  Symptomatic peripheral arterial disease Peripheral neuropathy\r\n      ","sponsor":"Hamilton Health Sciences Corporation","sponsor_type":"Other","conditions":"Postphlebitic Syndrome","interventions":[{"intervention_type":"Device","name":"Device: Veno-device (Venowave)"}],"outcomes":[{"outcome_type":"primary","measure":"Clinical Success measured with the Global Rating Instrument"},{"outcome_type":"secondary","measure":"PTS-CCS questionnaire"},{"outcome_type":"secondary","measure":"Villalta Scale"},{"outcome_type":"secondary","measure":"Veines Quality of Life Questionnaire"}]}
{"nct_id":"NCT00079027","start_date":"2004-04-30","phase":"Phase 3","enrollment":280,"brief_title":"Doxorubicin By Infusion or Chemoembolization in Treating Patients With Advanced Unresectable Hepatocellular Carcinoma (Liver Cancer)","official_title":"A Randomized Clinical Trial Evaluating the Benefits of Doxorubicin Chemoembolization Versus Systemic Doxorubicin in Patients With Unresectable, Advanced Hepatocellular Carcinoma","study_type":"Interventional","rec_status":"Unknown status","last_update":"2013-12-18","description":"RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping the cells from dividing. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor. It is not yet known whether doxorubicin is more effective with or without chemoembolization in treating unresectable hepatocellular carcinoma (liver cancer). PURPOSE: This randomized phase III trial is studying doxorubicin given by infusion to see how well it works compared to doxorubicin given by chemoembolization in treating patients with advanced liver cancer than cannot be removed by surgery.","other_id":"CDR0000353298","allocation":"Randomized","primary_purpose":"Treatment","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        DISEASE CHARACTERISTICS:\r\n\r\n          -  Histologically or cytologically confirmed hepatocellular carcinoma (HCC)\r\n\r\n               -  Advanced, unresectable disease\r\n\r\n          -  No clinically significant ascites\r\n\r\n          -  No modified Child-Pugh class C liver disease\r\n\r\n          -  No main portal vein occlusion/involvement\r\n\r\n          -  No extrahepatic tumor of any kind\r\n\r\n        PATIENT CHARACTERISTICS:\r\n\r\n        Age\r\n\r\n          -  18 and over (16 and over for patients residing in Scotland)\r\n\r\n        Performance status\r\n\r\n          -  ECOG 0-2\r\n\r\n        Life expectancy\r\n\r\n          -  More than 3 months\r\n\r\n        Hematopoietic\r\n\r\n          -  Absolute neutrophil count  1,500/mm^3\r\n\r\n          -  Hemoglobin  8.5 g/dL\r\n\r\n          -  Platelet count  100,000/mm^3\r\n\r\n        Hepatic\r\n\r\n          -  Bilirubin < 5.0 mg/dL\r\n\r\n          -  Transaminases < 2.5 times upper limit of normal (ULN)\r\n\r\n          -  INR < 1.5\r\n\r\n        Renal\r\n\r\n          -  Creatinine < 2 times ULN\r\n\r\n        Cardiovascular\r\n\r\n          -  No New York Heart Association class III or IV cardiac disease\r\n\r\n          -  No acute angina\r\n\r\n          -  No significant peripheral vascular disease\r\n\r\n          -  No thrombosis of main portal vein\r\n\r\n          -  LVEF  50%\r\n\r\n        Other\r\n\r\n          -  Not pregnant or nursing\r\n\r\n          -  Fertile patients must use effective contraception\r\n\r\n          -  No other concurrent serious medical condition\r\n\r\n          -  No serious infection\r\n\r\n          -  No psychological, familial, sociological, or geographical factors that would preclude\r\n             study compliance\r\n\r\n          -  No other malignancy within the past 5 years except carcinoma in situ of the cervix or\r\n             non-melanoma skin cancer\r\n\r\n        PRIOR CONCURRENT THERAPY:\r\n\r\n        Biologic therapy\r\n\r\n          -  No prior biologic therapy for advanced unresectable HCC\r\n\r\n        Chemotherapy\r\n\r\n          -  No prior systemic or regional chemotherapy\r\n\r\n          -  No prior chemotherapy for advanced unresectable HCC\r\n\r\n          -  No other concurrent anticancer chemotherapy\r\n\r\n        Endocrine therapy\r\n\r\n          -  No prior hormonal therapy for advanced unresectable HCC\r\n\r\n        Radiotherapy\r\n\r\n          -  No prior radiotherapy for advanced unresectable HCC\r\n\r\n          -  No other concurrent anticancer radiotherapy\r\n\r\n        Surgery\r\n\r\n          -  More than 7 days since prior major surgery\r\n\r\n          -  More than 3 days since prior laparoscopy\r\n\r\n        Other\r\n\r\n          -  More than 4 weeks since prior investigational agents\r\n\r\n          -  More than 6 weeks since prior ablative therapy and must have radiological evidence of\r\n             progression if ablated site is the only site of disease\r\n\r\n          -  No other concurrent investigational agents\r\n      ","sponsor":"University Hospital Birmingham","sponsor_type":"Other","conditions":"Liver Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: doxorubicin hydrochloride"},{"intervention_type":"Procedure","name":"Procedure: hepatic artery embolization"}],"outcomes":[{"outcome_type":"primary","measure":"Overall survival"},{"outcome_type":"secondary","measure":"Overall response"},{"outcome_type":"secondary","measure":"Quality of life as assessed by EORTC QOL QLQ-30 and EORTC QLQ HCC18 at baseline and 10 and 24 weeks"},{"outcome_type":"secondary","measure":"Time to progression as assessed by RECIST criteria"},{"outcome_type":"secondary","measure":"Toxicity"},{"outcome_type":"secondary","measure":"Health economics"},{"outcome_type":"secondary","measure":"Proteomic and immunological analysis"}]}
{"nct_id":"NCT00179101","start_date":"2004-04-30","enrollment":42,"brief_title":"Effect of Deep Brain Stimulation on Depression and Quality of Life in Parkinson's Patients","official_title":"Effect of Deep Brain Stimulation on Depression and Quality of Life in Parkinson's Patients","study_type":"Observational","rec_status":"Completed","completion_date":"2005-11-30","last_update":"2006-08-15","description":"We will evaluate the effect of deep brain stimulation on the depression and quality of life in Parkinson's disease. We aim to compare depression pre-operatively and post-operatively in Parkinson's patients with deep brain stimulation to Parkinson's patients evaluated and approved for deep brain stimulation but who did not complete surgery. We will also compare quality of life measures between patients with and without deep brain stimulation.","other_id":"040251","observational_model":"Defined Population","time_perspective":"Other","sampling_method":"","gender":"All","minimum_age":50,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients diagnosed with idiopathic Parkinson's disease.\r\n\r\n          -  Patients who have received neuropsychological testing in preparation for possible deep\r\n             brain stimulation.\r\n\r\n          -  Patients are within the age of 50 and 85.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Parkinson's patients not approved for deep brain stimulation on the basis of\r\n             neuropsychological testing.\r\n\r\n          -  Patients who received deep brain stimulation less than a year ago.\r\n\r\n          -  Patients who do not consent to the study procedures.\r\n      ","sponsor":"Vanderbilt University","sponsor_type":"Other","conditions":"Parkinson's Disease","interventions":[{"intervention_type":"Procedure","name":"Procedure: Deep Brain Stimulation"}],"outcomes":{}}
{"nct_id":"NCT00123773","start_date":"2004-04-30","phase":"Phase 2","enrollment":1075,"brief_title":"Study of F-Fluorodeoxyglucose (FluGlucoScan) in Patients With Known or Suspected Cancers of Low Incidence","official_title":"A Phase II Study of F-Fluorodeoxyglucose (FluGlucoScan) in Patients With Known or Suspected Cancers of Low Incidence","primary_completion_date":"2008-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-12-31","last_update":"2016-02-26","description":"Positron Emission Tomography (PET) is a specialised nuclear medicine procedure that uses positron emitting radiolabeled tracer molecules to measure biological activity. The most common of these radiolabeled tracers is 18F-fluorodeoxyglucose (18F-FDG), which is used to determine abnormal glucose metabolism in tumours and other sites. It has general applications in all areas where abnormal glucose metabolism may be present including in circumstances such as differentiating the tumour from scar tissue; evaluating the presence of the tumour in light of rising tumour markers and normal morphological imaging techniques; and assessing response to therapy where other techniques are deemed to be unhelpful. The Cross Cancer Institute has recently been funded to establish a PET centre, and this study will evaluate the effectiveness, value and safety of PET scanning in a number of uncommon cancers in the Canadian health care environment.","other_id":"SP-14-0038/DX-FDG-003/21386","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":15,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female. (If female of child bearing potential and outside of the window of 10\r\n             days since the last menstrual period, a negative serum or urine pregnancy test is\r\n             required.)\r\n\r\n          -  Known or suspected primary or metastatic tumours of myeloma, sarcoma, testicular\r\n             carcinoma (seminomatous and non-seminomatous germ cell tumours), endometrial\r\n             carcinoma, renal cell carcinoma, pancreatic adenocarcinoma, malignant mesothelioma,\r\n             gastric carcinoma and cholangiocarcinoma.\r\n\r\n          -  Age equal to or greater than 15 years\r\n\r\n          -  Able and willing to follow instructions and comply with the protocol\r\n\r\n          -  Provide written informed consent prior to participation in this study\r\n\r\n          -  Karnofsky Performance Scale score 60-100\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Nursing or pregnant females\r\n\r\n          -  Having had surgery or radiotherapy within 10 days of the planned imaging study\r\n\r\n          -  Presence of a severe infection\r\n\r\n          -  Age less than 15 years\r\n\r\n          -  Blood glucose greater than 10mmol/L\r\n      ","sponsor":"AHS Cancer Control Alberta","sponsor_type":"Other","conditions":"Sarcoma|Multiple Myeloma|Testicular Neoplasms|Ovarian Neoplasms|Kidney Neoplasms","interventions":[{"intervention_type":"Procedure","name":"Procedure: Positron Emission Tomography"}],"outcomes":[{"outcome_type":"primary","measure":"To confirm the diagnostic effectiveness of 18F-FDG in patients with known or suspected carcinoma"},{"outcome_type":"secondary","measure":"To determine the clinical relevance of PET scans within these patient groups"}]}
{"nct_id":"NCT00084877","start_date":"2004-03-31","phase":"Phase 1","enrollment":36,"brief_title":"Irinotecan and 3-AP in Treating Patients With Metastatic or Unresectable Solid Tumors","official_title":"A Phase I Study of Triapine in Combination With Irinotecan in Refractory Tumors","primary_completion_date":"2008-07-31","study_type":"Interventional","rec_status":"Completed","last_update":"2013-05-16","description":"This phase I trial is studying the side effects and best dose of irinotecan and 3-AP in treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy such as irinotecan work in different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may stop the growth of tumor cells by blocking the enzymes necessary for their growth and may help irinotecan kill more tumor cells by making them more sensitive to the drug.","other_id":"NCI-2013-00013","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients must have histologically confirmed malignancy that is metastatic or\r\n             unresectable and for which standard curative or palliative chemotherapy measures do\r\n             not exist or are no longer effective\r\n\r\n          -  Patients must not have previously received irinotecan\r\n\r\n          -  Patients must not have received radiation to > 25% of bone marrow\r\n\r\n          -  ECOG performance status =< 2\r\n\r\n          -  Life expectancy of greater than 12 weeks\r\n\r\n          -  Leukocytes >= 3,000/l\r\n\r\n          -  Absolute neutrophil count >= 1,500/l\r\n\r\n          -  Platelets >= 100,000/l\r\n\r\n          -  Total bilirubin within normal institutional limits\r\n\r\n          -  AST(SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal\r\n\r\n          -  Creatinine =< 1.5 mg/dl OR creatinine clearance >= 50 mL/min/1.73 m^2 for patients\r\n             with creatinine levels above institutional normal\r\n\r\n          -  Patients must have measurable or evaluable disease\r\n\r\n          -  Patients must have baseline screening for G6PD (glucose-6-phosphate dehydrogenase)\r\n             deficiency; G6PD must be no lower than the lower limit of normal prior to starting\r\n             study treatment; patients who are above the upper limit of normal may enroll in the\r\n             trial\r\n\r\n          -  The effects of Triapine on the developing human fetus are unknown; for this reason\r\n             and because heterocyclic carboxaldehyde thiosemicarbazones as well as other\r\n             therapeutic agents used in this trial are known to be teratogenic, women of\r\n             child-bearing potential and men must agree to use adequate contraception (hormonal or\r\n             barrier method of birth control; abstinence) prior to study entry and for the duration\r\n             of study participation; should a woman become pregnant or suspect she is pregnant\r\n             while participating in this study, she should inform her treating physician\r\n             immediately\r\n\r\n          -  Ability to understand and the willingness to sign a written informed consent document\r\n\r\n          -  Patients must have a baseline screening test for UGT1A1; the UGT1A1 cannot be the 7/7\r\n             genotype; patients who have any other combinations (6/6, 6/7, 5/7, etc.) may enroll in\r\n             the trial\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for\r\n             nitrosoureas or mitomycin C) prior to entering the study\r\n\r\n          -  Patients who have not recovered from adverse events due to agents administered more\r\n             than 4 weeks earlier; patients with grade 1 adverse events from prior therapies are\r\n             eligible at the investigator's discretion\r\n\r\n          -  Patients may not be receiving any other investigational agents\r\n\r\n          -  History of allergic reactions attributed to compounds of similar chemical or biologic\r\n             composition to Triapine or other agents used in study\r\n\r\n          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active\r\n             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac\r\n             arrhythmia, or psychiatric illness/social situations that would limit compliance with\r\n             study requirements\r\n\r\n          -  Pregnant women are excluded from this study because Triapine is a heterocyclic\r\n             carboxaldehyde thiosemicarbazone with the potential for teratogenic or abortifacient\r\n             effects; because there is an unknown but potential risk for adverse events in nursing\r\n             infants secondary to treatment of the mother with Triapine, breastfeeding should be\r\n             discontinued if the mother is treated with Triapine; these potential risks may also\r\n             apply to other agents used in this study\r\n\r\n          -  Patients with immune deficiency are at increased risk of lethal infections when\r\n             treated with marrow-suppressive therapy; therefore, HIV-positive patients receiving\r\n             combination anti-retroviral therapy are excluded from the study because of possible\r\n             pharmacokinetic interactions with Triapine or other agents administered during the\r\n             study; appropriate studies will be undertaken in patients receiving combination\r\n             anti-retroviral therapy when indicated\r\n\r\n          -  Patients with known G6PD deficiency are excluded\r\n\r\n          -  Patients with a history of myocardial infarction or severe pulmonary disease requiring\r\n             oxygen are excluded\r\n\r\n          -  Because of the potential for enzyme-inducing anticonvulsant agents (EIACAs) to alter\r\n             the metabolism and pharmacokinetics of irinotecan, patients who are taking EIACAs are\r\n             excluded\r\n\r\n          -  Metastatic brain or meningeal tumors unless the subject is > 6 months from definitive\r\n             therapy, had a negative imaging study within 4 weeks of study entry and is clinically\r\n             stable with respect to the tumor at the time of study entry; also the patient must not\r\n             be undergoing acute steroid therapy or taper\r\n\r\n          -  Patients with UGT1A1 7/7 genotype are excluded\r\n      ","sponsor":"National Cancer Institute (NCI)","sponsor_type":"NIH","conditions":"Unspecified Adult Solid Tumor, Protocol Specific","interventions":[{"intervention_type":"Drug","name":"Drug: triapine","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: irinotecan hydrochloride","description":"Given IV"},{"intervention_type":"Other","name":"Other: laboratory biomarker analysis","description":"Correlative studies"},{"intervention_type":"Other","name":"Other: pharmacological study","description":"Correlative studies"}],"outcomes":[{"outcome_type":"primary","measure":"Number and severity of toxicity incidents categorized via CTC standard toxicity grading","time_frame":"Up to 4 years","description":"Hematologic toxicity measures of thrombocytopenia, neutropenia and leukopenia will be assessed using the continuous variables as the outcome measures (primarily nadir and percent change from baseline values). Nonhematologic toxicities such as diarrhea and stomatitis will be evaluated via the ordinal CTC standard toxicity grading only. Frequency distributions and other descriptive measures will form the basis of the analysis of these variables."},{"outcome_type":"secondary","measure":"Number of responses","time_frame":"Up to 4 years","description":"Responses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease."}]}
{"nct_id":"NCT00153738","start_date":"2004-03-31","phase":"N/A","enrollment":72,"brief_title":"Phytosterol Supplementation and Cardiovascular Risk","official_title":"Effectiveness of Phytosterol Supplementation on Select Indices of Cardiovascular Risk","study_type":"Interventional","rec_status":"Completed","completion_date":"2005-08-31","last_update":"2014-03-13","description":"This study examined the effects of 2.6 g/d of phytosterol ingestion on LDL cholesterol metabolism. It is expected that this dose will significantly reduce LDL cholesterol after 12 weeks of supplementation.","other_id":"CI0129","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  mild hypercholesteremia, sign informed consent, not donate blood, maintain diet and\r\n             exercise habits\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  BMI <18.5 or >34.9, recent blood donation, serious or life-threatening disease\r\n      ","sponsor":"The Cooper Institute","sponsor_type":"Other","conditions":"Hypercholesteremia","interventions":[{"intervention_type":"Drug","name":"Drug: phytosterol"}],"outcomes":[{"outcome_type":"primary","measure":"Ingestion of the supplement will result in reduced LDL cholesterol."}]}
{"nct_id":"NCT00253422","start_date":"2004-03-31","phase":"Phase 3","enrollment":750,"brief_title":"Fulvestrant With or Without Anastrozole or Exemestane Alone in Treating Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer","official_title":"A Partially-Blind Phase III Randomized Trial of Fulvestrant (Faslodex) With or Without Concomitant Anastrozole (Arimidex) Compared With Exemestane in Postmenopausal Women With ER+ve Locally Advanced/Metastatic Breast Cancer Following Progression on Non-Steroidal Aromatase Inhibitors","primary_completion_date":"2016-05-31","study_type":"Interventional","rec_status":"Unknown status","last_update":"2011-05-17","description":"RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant, anastrozole, or exemestane may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes. It is not yet known whether giving fulvestrant together with anastrozole is more effective than giving fulvestrant together with a placebo or exemestane alone in treating breast cancer. PURPOSE: This randomized phase III trial is studying fulvestrant and anastrozole to see how well they work compared to fulvestrant and a placebo or exemestane alone in treating postmenopausal women with locally advanced or metastatic breast cancer.","other_id":"CDR0000448616","allocation":"Randomized","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"Female","population":"","criteria":"\n        DISEASE CHARACTERISTICS:\r\n\r\n          -  Histologically or cytologically confirmed adenocarcinoma of the breast\r\n\r\n               -  Locally advanced or metastatic disease\r\n\r\n          -  Metastatic disease must be measurable or evaluable\r\n\r\n               -  Patients with bone only metastases are eligible provided there is an evaluable\r\n                  site of bone metastasis that can be followed by x-ray, MRI, or CT scan\r\n\r\n          -  Relapsed or progressed during prior treatment with single-agent nonsteroidal aromatase\r\n             inhibitor (NSAI)*, meeting either of the following criteria:\r\n\r\n               -  NSAI given as adjuvant therapy that lasted  12 months\r\n\r\n               -  Achieved an objective complete response, partial response, or stable disease that\r\n                  lasted  6 months after prior first-line therapy with NSAI for locally advanced\r\n                  or metastatic disease\r\n\r\n                    -  Chemotherapy as part of the first-line therapy given before initiation of\r\n                       NSAI allowed NOTE: *Patients are required to continue to take NSAI until\r\n                       beginning of study treatment.\r\n\r\n          -  No rapidly progressive visceral disease (i.e., lymphangitis carcinomatosa or diffuse\r\n             hepatic involvement)\r\n\r\n          -  Hormone receptor status:\r\n\r\n               -  Estrogen receptor (ER) and/or progesterone receptor positive tumor\r\n\r\n               -  No ER-unknown disease\r\n\r\n        PATIENT CHARACTERISTICS:\r\n\r\n        Sex\r\n\r\n          -  Female\r\n\r\n        Menopausal status\r\n\r\n          -  Postmenopausal, as defined by 1 of the following criteria:\r\n\r\n               -  Age 60 and over\r\n\r\n               -  Age 45 to 59 AND  12 months since last menstrual period with no prior\r\n                  hysterectomy\r\n\r\n               -  Any age with prior bilateral oophorectomy\r\n\r\n        Performance status\r\n\r\n          -  WHO 0-2\r\n\r\n        Life expectancy\r\n\r\n          -  More than 3 months\r\n\r\n        Hematopoietic\r\n\r\n          -  Neutrophil count  1,500/mm^3\r\n\r\n          -  Platelet count  100,000/mm^3\r\n\r\n               -  No thrombocytopenia\r\n\r\n          -  Hemoglobin  10 g/dL\r\n\r\n        Hepatic\r\n\r\n          -  AST and ALT  2.5 times upper limit of normal (ULN)\r\n\r\n          -  Alkaline phosphatase  5 times ULN (unless due to bone metastases)\r\n\r\n          -  No liver disease\r\n\r\n        Renal\r\n\r\n          -  Creatinine < 1.97 mg/dL\r\n\r\n        Other\r\n\r\n          -  No other malignancy within the past 5 years except adequately treated basal cell or\r\n             squamous cell skin cancer or carcinoma in situ of the cervix\r\n\r\n        PRIOR CONCURRENT THERAPY:\r\n\r\n        Chemotherapy\r\n\r\n          -  See Disease Characteristics\r\n\r\n          -  Prior neoadjuvant or adjuvant chemotherapy allowed\r\n\r\n        Endocrine therapy\r\n\r\n          -  See Disease Characteristics\r\n\r\n          -  Prior tamoxifen as neoadjuvant or adjuvant therapy allowed\r\n\r\n          -  No systemic corticosteroids that lasted > 15 days within the past 4 weeks\r\n\r\n        Other\r\n\r\n          -  More than 4 weeks since prior investigational drugs\r\n\r\n          -  Concurrent bisphosphonates for bone metastases allowed provided bisphosphonate therapy\r\n             has been established for  6 months\r\n\r\n               -  Concurrent initiation of bisphosphonate allowed provided patient has soft tissue\r\n                  or visceral metastases as the measurable or evaluable target lesion\r\n\r\n          -  No concurrent anticoagulant therapy\r\n\r\n          -  No concurrent unlicensed noncancer investigational agents\r\n      ","sponsor":"Institute of Cancer Research, United Kingdom","sponsor_type":"Other","conditions":"Breast Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: anastrozole"},{"intervention_type":"Drug","name":"Drug: exemestane"},{"intervention_type":"Drug","name":"Drug: fulvestrant"}],"outcomes":[{"outcome_type":"secondary","measure":"Duration of clinical benefit"},{"outcome_type":"secondary","measure":"Time to treatment failure"},{"outcome_type":"secondary","measure":"Overall survival"},{"outcome_type":"secondary","measure":"Tolerability"},{"outcome_type":"primary","measure":"Progression-free survival"},{"outcome_type":"secondary","measure":"Objective complete response (CR) and partial response (PR) rate"},{"outcome_type":"secondary","measure":"Duration of response"},{"outcome_type":"secondary","measure":"Clinical benefit (i.e., 6-month CR, PR, and stable disease) rate"}]}
{"nct_id":"NCT00280813","start_date":"2004-03-31","phase":"N/A","enrollment":54,"brief_title":"Alcohol Use Disorders in Schizophrenia","official_title":"Treatment of Alcohol Use Disorders in Schizophrenia","primary_completion_date":"2007-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-05-31","last_update":"2020-04-06","description":"The purpose of the study is to evaluate a new treatment to help patients who have problems because of their use of alcohol. The treatment is called Behavioral Treatment for Alcohol Abuse in Schizophrenia (BTAAS).We are interested in determining whether BTAAS is more effective in reducing use than a supportive control treatment.","other_id":"21942","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":22,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  DSM-IV diagnosis of schizophrenia or schizoaffective disorder OR other severe disorder\r\n             including bipolar disorder, major depression, or severe anxiety disorder (by\r\n             definition, the patient has worked 25% or less of the past year; and/or the patient\r\n             received payment for mental disability)\r\n\r\n          -  Current (last month) Alcohol Abuse or Dependence or Alcohol Abuse or Dependence\r\n             criteria met within the last 3 months as determined by the Structured Clinical\r\n             Interview for DSM-IV.\r\n\r\n          -  Ability to provide informed consent\r\n\r\n          -  Stable housing\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Current neurological disorder or cognitive impairment due to head injury or loss of\r\n             consciousness that would impact ability to effectively participate in the intervention\r\n\r\n          -  Mental retardation as indicated by chart review\r\n\r\n          -  inability to effectively participate in the baseline assessments due to intoxication\r\n             or psychiatric symptoms on two successive appointments\r\n\r\n          -  patient is homeless.\r\n\r\n          -  Inability to attend scheduled treatment sessions on a regular basis for any reason, or\r\n             to appropriately participate in research activities due to behavioral or psychiatric\r\n             problems.\r\n      ","sponsor":"University of Maryland, Baltimore","sponsor_type":"Other","conditions":"Schizophrenia|Mood Disorders|Alcohol Abuse|Alcohol Dependence","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Supportive Treatment in Addiction Recovery (STAR)"}],"outcomes":[{"outcome_type":"primary","measure":"Symptom ratings, addiction severity, quality of life, social functioning & motivation to change: baseline and post-treatment.","time_frame":"1 year"},{"outcome_type":"secondary","measure":"Saliva test & Urinalysis: baseline, post-treatment and at each treatment session.","time_frame":"1 year"}]}
{"nct_id":"NCT00800215","start_date":"2004-03-31","phase":"Phase 2","enrollment":60,"brief_title":"A Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous SPM 927","official_title":"A Multicenter, Double-blind, Double-dummy, Randomized Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous SPM 927 as Replacement for Oral SPM 927 in Subjects With Partial Seizures With or Without Secondary Generalization","primary_completion_date":"2004-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2004-11-30","last_update":"2015-05-27","description":"The purpose of this trial was to evaluate the safety and tolerability of SPM 927 when given as iv infusions compared with oral administration of the same dose strengths in subjects who were receiving oral SPM 927 for partial seizures with or without secondary generalization. Trial procedures will include medical history update, physical/ neurological exams, ECGs, blood /urine sample collections and seizure diary completion. Subjects completing the trial will return to the OLE trial to resume dosing with oral SPM 927.","other_id":"SP616","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subject with partial seizures with or without secondary generalization\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Subject had previously received iv SPM 927\r\n\r\n          -  Subject met the withdrawal criteria for the open-label extension trial with SPM 927 or\r\n             was experiencing an ongoing serious adverse event.\r\n      ","sponsor":"UCB Pharma","sponsor_type":"Industry","conditions":"Epilepsy","interventions":[{"intervention_type":"Drug","name":"Drug: iv SPM 927 and oral placebo tablet","description":"60-minute infusion iv SPM 927 and oral placebo tablet"},{"intervention_type":"Drug","name":"Drug: oral SPM 927 tablet and iv placebo","description":"60-minute infusion placebo and oral SPM 927 tablet"},{"intervention_type":"Drug","name":"Drug: iv SPM 927 and oral placebo tablet","description":"30-minute infusion iv SPM 927 and oral placebo tablet"},{"intervention_type":"Drug","name":"Drug: oral SPM 927 tablet and iv placebo","description":"30-minute infusion placebo and oral SPM 927 tablet"}],"outcomes":[{"outcome_type":"primary","measure":"Adverse events, Vital signs, electrocardiograms,Physical examination, neurological examination","time_frame":"2 Days"},{"outcome_type":"secondary","measure":"Seizure counts","time_frame":"2 days"}]}
{"nct_id":"NCT00231647","start_date":"2004-02-29","phase":"Phase 2","enrollment":113,"brief_title":"A Study on Efficacy and Safety of Topiramate OROS Controlled-Release in Obese, Type 2 Diabetic Subjects Managed With Diet or Metformin","official_title":"A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study to Assess the Efficacy and Safety of Topiramate OROS Controlled-Release in the Treatment of Obese, Type 2 Diabetic Subjects Managed With Diet or Metformin","study_type":"Interventional","rec_status":"Completed","completion_date":"2004-10-31","last_update":"2011-06-08","description":"The purpose of this study is to evaluate the effectiveness and safety of a topiramate controlled-release formulation in the treatment of obese, type 2 diabetic patients managed with diet alone or combined with metformin.","other_id":"CR002674","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Body Mass Index (BMI) >= 27 kg/m^2 and <50 kg/m^2\r\n\r\n          -  Diagnosis of type 2 diabetes, managed with either diet alone or combined with\r\n             monotherapy treatment with metformin\r\n\r\n          -  Stable weight for at least 2 months\r\n\r\n          -  Female patients must be postmenopausal for at least 1 year, surgically incapable of\r\n             childbearing, practicing abstinence, or practicing an acceptable method of\r\n             contraception (requires negative pregnancy test).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Contraindication or hypersensitivity to topiramate\r\n\r\n          -  Exposure to any other experimental drug or device within past 90 days\r\n\r\n          -  Established diagnosis of Type 1 diabetes\r\n\r\n          -  History of severe or recurrent hypoglycemic episodes prior to study entry\r\n\r\n          -  Taking oral antidiabetic medications other than metformin\r\n\r\n          -  Treatment with insulin within 4 months\r\n\r\n          -  Significant liver, kidney or cardiovascular diseases.\r\n      ","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","sponsor_type":"Industry","conditions":"Obesity|Diabetes Mellitus, Type 2|Diabetes Mellitus, Adult-Onset","interventions":[{"intervention_type":"Drug","name":"Drug: topiramate"}],"outcomes":[{"outcome_type":"primary","measure":"Percent change in body weight from baseline to Week 16."},{"outcome_type":"secondary","measure":"Changes in body weight, body mass index,anthropometric measurements (waste and hip circumference and their ratio),fasting blood glucose and lipid profile from baseline to Week 16; safety evaluations including incidence of adverse events during the study."}]}
{"nct_id":"NCT00274404","start_date":"2004-02-29","phase":"Phase 1/Phase 2","enrollment":20,"brief_title":"Controlled Trial of Valacyclovir in Infectious Mononucleosis","official_title":"Randomized Study Assessing the Antiviral Activity and Safety of Valacyclovir in Primary Infectious Mononucleosis","primary_completion_date":"2005-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2005-09-30","last_update":"2011-10-27","description":"The hypothesis is that an antiviral drug (valacyclovir) will reduce the amount of Epstein-Barr virus (EBV) in the mouths of university students with infectious mononucleosis (mono) while being a safe drug. Because EBV is the cause of mono, it is expected that reduction of the amount of virus could result in faster recovery from the disease.","other_id":"0311M53430","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Clinical diagnosis of infectious mononucleosis with onset no more the 7 days before\r\n             enrollment; willingness to sign informed consent\r\n\r\n          -  Willingness to provide blood and oral washing samples at regular intervals\r\n\r\n          -  Females must have a negative urine pregnancy test and agree to use effective\r\n             contraception (barrier or hormonal) for the first 30 days of the study if assigned to\r\n             valacyclovir\r\n\r\n          -  Corticosteroids are permitted only if prescribed by the subject's primary physisican\r\n             for treatment of this acute disease\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Previous history of mono\r\n\r\n          -  Pregnant or breast feeding\r\n\r\n          -  End-stage renal or liver disease\r\n\r\n          -  Immunosuppressed due to underlying medical disease and/or immunomodulating medications\r\n             prior to enrollment\r\n\r\n          -  Onset of present illness >7 days ago\r\n      ","sponsor":"University of Minnesota","sponsor_type":"Other","conditions":"Infectious Mononucleosis","interventions":[{"intervention_type":"Drug","name":"Drug: valacyclovir"}],"outcomes":[{"outcome_type":"primary","measure":"Proportion of subjects who have at least a 100-fold (2log10) drop in the amount of EBV in their oral washes during the 14-day treatment period"},{"outcome_type":"secondary","measure":"Evaluate the safety and tolerability of valacyclovir"},{"outcome_type":"secondary","measure":"Evaluate the quantity of EBV in the oral washings"},{"outcome_type":"secondary","measure":"Correlate severity of illness with the amount of virus in the oral and blood compartments"},{"outcome_type":"secondary","measure":"Evaluate the areas under the viral load - time curves"}]}
{"nct_id":"NCT00077883","start_date":"2004-02-29","phase":"Phase 1/Phase 2","enrollment":50,"brief_title":"TLK286 (Telcyta) in Combination With Cisplatin for Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)","official_title":"Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Cisplatin as First-Line Therapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer","primary_completion_date":"2007-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-03-31","last_update":"2011-07-25","description":"The purpose of this trial is to study the efficacy and safety of the combination of TLK286 with cisplatin as first-line therapy for patients with locally advanced or metastatic non-small cell lung cancer.","other_id":"TLK286.2021","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18 years of age or older\r\n\r\n          -  Histologically confirmed non-small cell lung cancer\r\n\r\n          -  Stage IV or IIIB\r\n\r\n          -  Measurable disease by RECIST\r\n\r\n          -  ECOG performance status of 0-1\r\n\r\n          -  Adequate liver and renal function\r\n\r\n          -  Adequate bone marrow reserve\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of bone marrow transplantation or stem cell support\r\n\r\n          -  Pregnant or lactating women\r\n      ","sponsor":"Telik","sponsor_type":"Industry","conditions":"Non-small Cell Lung Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: TLK286, cisplatin","description":"TLK286 administered once every 3 weeks ( 2 days) at two dose-ranging levels (750 mg/m) and 1,000 mg/) in combination with two dose levels of cisplatin (75 mg/m and 100 mg/m) of cisplatin once every 3 weeks ( 2 days)."}],"outcomes":[{"outcome_type":"primary","measure":"Primary Objectives of the Study","time_frame":"Every 3 weeks","description":"To determine the safety of TLK286 in combination with cisplatin in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)\r\nTo determine the MTD of TLK286 in combination with cisplatin in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)"}]}
{"nct_id":"NCT00077454","start_date":"2004-02-29","phase":"Phase 1","enrollment":95,"brief_title":"Erlotinib and Temozolomide in Treating Young Patients With Recurrent or Refractory Solid Tumors","official_title":"A Phase I Study of Single Agent OSI-774 (Tarceva) (NSC# 718781, IND# 63383) Followed by OSI-774 With Temozolomide for Patients With Selected Recurrent/Refractory Solid Tumors, Including Brain Tumors","primary_completion_date":"2007-09-30","study_type":"Interventional","rec_status":"Completed","last_update":"2013-06-05","description":"This phase I trial is studying the side effects and best dose of erlotinib when given with temozolomide in treating young patients with recurrent or refractory solid tumors. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving erlotinib with temozolomide may kill more tumor cells.","other_id":"NCI-2012-01808","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","maximum_age":21,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  One of the following histologically confirmed solid tumors:\r\n\r\n               -  Brain tumors\r\n\r\n               -  Osteogenic sarcoma\r\n\r\n               -  Rhabdomyosarcoma\r\n\r\n               -  Soft tissue sarcoma (excluding Ewing's sarcoma)\r\n\r\n               -  Neuroblastoma\r\n\r\n               -  Germ cell tumors\r\n\r\n          -  Recurrent or refractory disease\r\n\r\n          -  No known curative therapy exists\r\n\r\n          -  Performance status - Karnofsky 50-100% (for patients age 11 to 21)\r\n\r\n          -  Performance status - Lansky 50-100% (for patients age 10 and under)\r\n\r\n          -  At least 8 weeks\r\n\r\n          -  Absolute neutrophil count > 1,000/mm^3\r\n\r\n          -  Platelet count > 100,000/mm^3 (transfusion independent*)\r\n\r\n          -  Hemoglobin > 8.0 g/dL (transfusion allowed)\r\n\r\n          -  Bilirubin < 1.5 times upper limit of normal (ULN)\r\n\r\n          -  ALT < 2.5 times ULN\r\n\r\n          -  Albumin  2 g/dL\r\n\r\n          -  Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min\r\n\r\n          -  Creatinine based on age as follows:\r\n\r\n               -   0.8 mg/dL for patients age 5 and under\r\n\r\n               -   1.0 mg/dL for patients 6 to 10\r\n\r\n               -   1.2 mg/dL for patients 11 to 15\r\n\r\n               -   1.5 mg/dL for patients age 15 to 21\r\n\r\n          -  Not pregnant or nursing\r\n\r\n          -  Negative pregnancy test\r\n\r\n          -  Fertile patients must use effective contraception\r\n\r\n          -  Able to swallow tablets (for patients in part 2 only)\r\n\r\n          -  No uncontrolled infection\r\n\r\n          -  Recovered from all prior immunotherapy\r\n\r\n          -  At least 7 days since prior biologic therapy\r\n\r\n          -  At least 3 months since prior stem cell transplantation and no evidence of active\r\n             graft-versus-host disease\r\n\r\n          -  More than 1 week since prior growth factors\r\n\r\n          -  No concurrent prophylactic growth factor therapy\r\n\r\n          -  No concurrent immunotherapy\r\n\r\n          -  No concurrent biologic therapy\r\n\r\n          -  More than 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas)\r\n             and recovered\r\n\r\n          -  No other concurrent chemotherapy\r\n\r\n          -  No concurrent systemic corticosteroids except for treatment of increased intracranial\r\n             pressure or symptomatic tumor edema in patients with CNS tumors\r\n\r\n               -  No concurrent steroids as an antiemetic\r\n\r\n          -  Concurrent dexamethasone for patients with CNS tumors allowed provided patient has\r\n             been on a stable or decreasing dose for at least 1 week before study entry\r\n\r\n          -  Recovered from all prior radiotherapy\r\n\r\n          -  At least 2 weeks since prior local palliative radiotherapy (small port)\r\n\r\n          -  At least 6 weeks since prior substantial bone marrow irradiation\r\n\r\n          -  At least 6 months since prior craniospinal radiotherapy\r\n\r\n          -  At least 6 months since prior radiotherapy to 50% or more of the pelvis\r\n\r\n          -  At least 8 weeks since prior standard-fraction radiotherapy for patients with\r\n             recurrent brain tumors unless there is biopsy proof of recurrent tumor\r\n\r\n          -  Prior radiosurgery within the past 9 months allowed provided there is documentation of\r\n             progressive disease by biopsy, positron-emission tomography (PET) scan, or MR\r\n             spectroscopy\r\n\r\n          -  No concurrent radiotherapy\r\n\r\n          -  More than 1 week since prior CYP3A4 inhibitors\r\n\r\n          -  More than 4 weeks since prior CYP3A4 inducers\r\n\r\n          -  More than 5 days since prior proton-pump inhibitors\r\n\r\n          -  More than 2 days since prior H_2 blockers\r\n\r\n          -  No prior erlotinib\r\n\r\n          -  No concurrent enzyme-inducing anticonvulsants\r\n\r\n          -  No concurrent proton-pump inhibitors\r\n\r\n          -  No concurrent H2 blockers\r\n\r\n          -  No other concurrent investigational agents\r\n\r\n          -  Concurrent antacids allowed provided the antacid is not administered 2 hours before,\r\n             during, and 2 hours after erlotinib administration\r\n      ","sponsor":"National Cancer Institute (NCI)","sponsor_type":"NIH","conditions":"Previously Treated Childhood Rhabdomyosarcoma|Recurrent Childhood Brain Tumor|Recurrent Childhood Cerebellar Astrocytoma|Recurrent Childhood Cerebral Astrocytoma|Recurrent Childhood Ependymoma|Recurrent Childhood Malignant Germ Cell Tumor|Recurrent Childhood Medulloblastoma|Recurrent Childhood Rhabdomyosarcoma|Recurrent Childhood Soft Tissue Sarcoma|Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor|Recurrent Neuroblastoma|Recurrent Osteosarcoma","interventions":[{"intervention_type":"Drug","name":"Drug: erlotinib hydrochloride","description":"Given orally (PO)"},{"intervention_type":"Drug","name":"Drug: temozolomide","description":"Given PO"},{"intervention_type":"Other","name":"Other: pharmacological study","description":"Correlative studies"},{"intervention_type":"Other","name":"Other: laboratory biomarker analysis","description":"Correlative studies"}],"outcomes":[{"outcome_type":"primary","measure":"Dose-limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0","time_frame":"56 days (2 courses)"},{"outcome_type":"primary","measure":"Maximum-tolerated dose (MTD) based on the incidence of DLT as assessed by NCI CTCAE version 3.0","time_frame":"56 days (2 courses)"},{"outcome_type":"primary","measure":"Pharmacokinetics of erlotinib hydrochloride","time_frame":"At baseline and at 0.5, 1, 2, 4, 6, 8, and 24 hours of course 1"}]}
{"nct_id":"NCT00581919","start_date":"2004-02-29","phase":"Phase 2","enrollment":32,"brief_title":"Ph 2 Bortezomib, Dexamethasone, + Doxorubicin With ALCAR for Previously Treated Multiple Myeloma","official_title":"Phase II Trial of Bortezomib, Low Dose Dexamethasone, and Doxorubicin With Acetyl-L-Carnitine for Neuroprotection in Patients With Previously Treated Multiple Myeloma","primary_completion_date":"2010-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-07-31","last_update":"2019-12-13","description":"Patients will receive Bortezomib, Dexamethasone, and Doxorubicin in 21 day cycles a total of 4 to 8 times (based on response to the treatment). Patients will also receive acetyl-L-carnitine (ALCAR) daily.","other_id":"HO04402","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with previously treated multiple myeloma with measurable serum or urine\r\n             monoclonal protein.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with previous doxorubicin treatment totaling 220 mg/m2 or more\r\n\r\n          -  LVEF less than 45%\r\n\r\n          -  Patients with >grade II sensory neuropathy at baseline as assessed by the PI will be\r\n             excluded\r\n\r\n          -  No history of seizures as ALCAR may lower the seizure threshold\r\n\r\n          -  Known HIV infection\r\n\r\n          -  Current pregnancy.\r\n      ","sponsor":"University of Wisconsin, Madison","sponsor_type":"Other","conditions":"Multiple Myeloma","interventions":[{"intervention_type":"Drug","name":"Drug: Bort, Dex, and Dox with ALCAR","description":"Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long"}],"outcomes":[{"outcome_type":"primary","measure":"Confirmed Anti-tumor Response Rate (Complete Response and Partial Response) to the Combination of Bortezomib, Dexamethasone, Doxorubicin, and ALCAR","time_frame":"Every 21 days, up to 24 weeks","description":"Anti-tumor responses were analyzed descriptively and summarized in tabular format. Ninety percent confidence intervals for the percentage of subjects with a confirmed anti-tumor response were constructed using the method proposed by Duffy-Santner.\r\nComplete response defined as: no evidence of M-protein on immunofixation of serum and/or urine AND less than 5% plasma cells in the bone marrow biopsy.\r\nPartial response defined as: 50 to 99% decrease in M-protein on serum and/or urine protein electrophoresis."},{"outcome_type":"secondary","measure":"Overall Survival","time_frame":"From date of randomization until the date of death from any cause, assessed up to 7 years"},{"outcome_type":"secondary","measure":"Progression-free Survival","time_frame":"From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 years.","description":"Progression is defined as any of the following: 1) 25% or greater increase in M-protein as measured by serum or urine protein electrophoresis. There must be an absolute minimum increase of 0.5 g/dl in serum M spike or 0.2 gram of specific urinary light chains to constitute progression, 2) 25% or greater increase in the percentage or plasma cells in the bone marrow biopsy, or 3) new bone lesions or an increase in the size of old lesions on x-ray."}]}
{"nct_id":"NCT00429195","start_date":"2004-02-29","phase":"N/A","enrollment":480,"brief_title":"The Effect of Dietary Fat Modification on Risk Factors Associated With the Metabolic Syndrome","official_title":"LIPGENE Dietary Intervention Study","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-01-31","last_update":"2013-01-21","description":"The LIPGENE Human Dietary Intervention Study, multi-centre, trans -European, single-blinded, randomised, controlled trial with two principal aims. Firstly to determine the relative efficacy of reducing dietary SFA consumption, by altering quality of dietary fat and reducing the quantity of dietary fat, on metabolic and molecular risk factors of the metabolic syndrome. Secondly to determine if common genetic polymorphisms affect an individual's responsiveness to dietary therapy.","other_id":"LIPGENE Dietary Intervention","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":35,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Gender: males and females (not pregnant or lactating).\r\n\r\n          -  Body Mass Index (BMI) 20-40 kg/m2\r\n\r\n          -  Total cholesterol concentration equal to or < 8.0 mmol/l.\r\n\r\n          -  Medications / nutritional supplements allowed, on condition that the subjects adhere\r\n             to the same regimen during the intervention: anti-hypertensive medication (including\r\n             beta-blockers), oral contraceptives, hormone replacement therapy, multi-vitamin\r\n             supplements, other non-fatty acid based nutritional supplements (e.g. garlic,\r\n             anti-oxidants, etc).\r\n\r\n          -  Smokers and non-smokers.\r\n\r\n          -  Regular consumers of alcohol, which is not excessive as defined by elevated liver\r\n             enzymes (AST and ALT).\r\n\r\n          -  Ethnicity: Intention to include white Europeans.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Diabetes or other endocrine disorders.\r\n\r\n          -  Chronic inflammatory conditions.\r\n\r\n          -  Kidney or liver dysfunction.\r\n\r\n          -  Iron deficiency anaemia (haemoglobin < 12g/dl men, < 11g/dl women)\r\n\r\n          -  Prescribed hypolipidaemic medication\r\n\r\n          -  Prescribed anti-inflammatory medication\r\n\r\n          -  Fatty acid supplements including fish oils, evening primrose oil, etc.\r\n\r\n          -  Consumers of high doses of antioxidant vitamins (A, C, E, beta-carotene).\r\n\r\n          -  Red rice yeast (Monascus purpureus) supplement usage.\r\n\r\n          -  High consumers of oily fish (> 2 serving of oily fish per week of herring, mackerel,\r\n             kippers, pilchards, sardines, salmon, trout, tuna (fresh), crabmeat or marlin). One\r\n             portion is defined as a small herring or mackerel, one can of salmon or sardines or\r\n             one salmon or tuna steak. Tinned tuna is permitted as it contains only minor amounts\r\n             of long chain n-3 PUFAs.\r\n\r\n          -  Highly trained or endurance athletes or those who participate in more than 3 periods\r\n             of intense exercise per week.\r\n\r\n          -  Volunteers planning to start a special diet or loose weight (e.g. the Slimfast Plan,\r\n             Atkins Diet etc).\r\n\r\n          -  Weight change equal or >3kg within the last 3 months.\r\n\r\n          -  Alcohol or drug abuse (based on clinical judgement).\r\n\r\n          -  Pregnant / lactating females / women planning a pregnancy in the next 12 months. Women\r\n             who become pregnant during the dietary intervention period should be removed from the\r\n             study.\r\n      ","sponsor":"University College Dublin","sponsor_type":"Other","conditions":"Metabolic Syndrome","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Dietary Fatty Acid Modification"}],"outcomes":[{"outcome_type":"primary","measure":"IVGTT"},{"outcome_type":"primary","measure":"Lipoprotein metabolism"},{"outcome_type":"primary","measure":"Cytokine profiles"},{"outcome_type":"primary","measure":"Coagulation"},{"outcome_type":"primary","measure":"Fibrinolysis"},{"outcome_type":"primary","measure":"Oxidative status"}]}
{"nct_id":"NCT00202670","start_date":"2004-01-31","enrollment":220,"brief_title":"Diagnosis of Coronary Artery Disease in High Risk Diabetic Patients","official_title":"Diagnosis of Coronary Artery Disease in High Risk Diabetic Patients :Comparison Between Stress Echocardiography and Stress Scintigraphy in the Detection of Silent Myocardial Ischemia","primary_completion_date":"2010-05-31","study_type":"Observational","rec_status":"Terminated","completion_date":"2010-06-30","last_update":"2010-10-20","description":"The aim of this study is to determine in high risk diabetics if the positive predictive value of stress echocardiography is superior to the positive predictive value of stress scintigraphy in the diagnosis of coronary stenosis > 50%.","other_id":"2003-04","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"high risk diabetic patients","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  type 2 diabetic patients in women> 60 yo or men > 55 yo, with high risk of coronary\r\n             artery disease (EF < 40%, ECG abnormalities, renal failure , 2 others risk factors of\r\n             atherosclerosis)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  previous documented CAD acute coronary syndrome\r\n      ","sponsor":"Socit Franaise de Cardiologie","sponsor_type":"Other","conditions":"Diabetes Mellitus","interventions":{},"outcomes":{}}
{"nct_id":"NCT00315770","start_date":"2004-01-31","phase":"Phase 1","enrollment":320,"brief_title":"Health of Young European Families and Fish Consumption","official_title":"Health of Young European Families and Fish Consumption","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2020-04-30","last_update":"2018-08-10","description":"This is a controlled, randomized, intervention trial (CRIT) with 20-40 year old overweight individuals (n = 320) across Europe in order to distinguish between biologically active components of seafood, i.e., seafood proteins and n-3 lipids, regarding their effects on risk factors for metabolic syndrome, bone health, and weight management.","other_id":"FQS-506359","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Body mass index (BMI) of 27.5 to 32.5 kg/m2\r\n\r\n          -  Ages 20-40 years\r\n\r\n          -  Waist circumference of equal or more than 94 cm and 80 cm for men and women,\r\n             respectively\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Weight change due to weight loss diet within 3 months before the start of the study\r\n\r\n          -  Use of supplements giving n-3 fatty acids\r\n\r\n          -  Calcium or vitamin D during the last three months\r\n\r\n          -  Drug treatment for diabetes mellitus\r\n\r\n          -  Hypertension or hyperlipidemia\r\n\r\n          -  Women's pregnancy or lactation\r\n      ","sponsor":"Landspitali University Hospital","sponsor_type":"Other","conditions":"Overweight|Metabolic Syndrome X|Bone Resorption","interventions":[{"intervention_type":"Procedure","name":"Procedure: weight loss diets for young adults"}],"outcomes":[{"outcome_type":"primary","measure":"Weight loss"},{"outcome_type":"primary","measure":"Anthropometry"},{"outcome_type":"secondary","measure":"Blood lipid profile (total high-density lipoprotein [HDL]- and low-density lipoprotein (LDL)-cholesterol, triacylglycerol)"},{"outcome_type":"secondary","measure":"Fatty acid composition of red blood cells"},{"outcome_type":"secondary","measure":"Fasting plasma glucose and fasting insulin"},{"outcome_type":"secondary","measure":"C-reactive protein"},{"outcome_type":"secondary","measure":"Prostaglandins"},{"outcome_type":"secondary","measure":"Interleukins"},{"outcome_type":"secondary","measure":"Intercellular adhesion molecules"},{"outcome_type":"secondary","measure":"Vascular cell adhesion molecules"},{"outcome_type":"secondary","measure":"Antioxidants/pro-oxidants"},{"outcome_type":"secondary","measure":"Serum ghrelin"},{"outcome_type":"secondary","measure":"Leptin"},{"outcome_type":"secondary","measure":"Quantitative insulin-sensitivity check index (QUICKI)"},{"outcome_type":"secondary","measure":"Adiponectin"},{"outcome_type":"secondary","measure":"Plasminogen activator inhibitor (PAI-1)"},{"outcome_type":"secondary","measure":"Cortisol"},{"outcome_type":"secondary","measure":"Glutathione (GSH) reductase"},{"outcome_type":"secondary","measure":"Malondialdehyde"},{"outcome_type":"secondary","measure":"Bone specific alkaline phosphatase"},{"outcome_type":"secondary","measure":"Osteocalcin"},{"outcome_type":"secondary","measure":"Parathyroid hormone (PTH)"},{"outcome_type":"secondary","measure":"25-hydroxyvitamin D3 [25(OH) D3]"},{"outcome_type":"secondary","measure":"Creatinine"},{"outcome_type":"secondary","measure":"Pyridinoline (Pyr) and deoxypyridinoline (Dpyr)"},{"outcome_type":"secondary","measure":"Visual analogue scale for satiety"}]}
{"nct_id":"NCT00803166","start_date":"2004-01-31","enrollment":60,"brief_title":"Randomized Study to Compare the Bioavailability of Three Halobetasol Propionate 0.05% Topical Creams","official_title":"Bioequivalence of Three Halobetasol Propionate 0.05% Topical Creams","primary_completion_date":"2004-01-31","study_type":"Observational","rec_status":"Completed","completion_date":"2004-01-31","last_update":"2012-03-16","description":"The purpose of this study was to compare the relative vasoconstrictive effects of two test and one reference Halobetasol Propionate 0.05% Cream in healthy, female subjects.","other_id":"10316926","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"Female","minimum_age":18,"maximum_age":50,"population":"Healthy Community Volunteers","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Non-tobacco using female subjects, 18 to 50 years of age\r\n\r\n          -  Demonstrated blanching response to Reference Drug\r\n\r\n          -  Body Mass Index (BMI) of 30 or less\r\n\r\n          -  Good health as determined by lack of clinically significant abnormalities in medical\r\n             history and clinical assessment, as judged by the Investigator\r\n\r\n          -  Signed and dated informed consent form which meets all criteria of current FDA\r\n             regulations\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of allergy to systemic or topical corticosteroids\r\n\r\n          -  Presence of any skin condition or coloration that would interfere with the placement\r\n             of test sites or the response or assessment of skin blanching\r\n\r\n          -  Presence of medical condition requiring regular treatment with prescription drugs\r\n\r\n          -  Drug or alcohol addiction requiring treatment in the past 12 months prior to dosing\r\n\r\n          -  Use of any tobacco products in the 30 days prior to study dosing\r\n\r\n          -  Use of any dermatological drug therapy on the flexor surface of the forearms within 30\r\n             days of dosing\r\n\r\n          -  Receipt of any drugs as part of a research study within 30 days prior to study dosing\r\n\r\n          -  Pregnant or lactating\r\n      ","sponsor":"Perrigo Company","sponsor_type":"Industry","conditions":"Healthy","interventions":[{"intervention_type":"Drug","name":"Drug: Halobetasol Propionate 0.05% Cream-Reference Product","description":"Small amount applied and evaluated over the course of three days"},{"intervention_type":"Drug","name":"Drug: Halobetasol Propionate 0.05% Cream-Test product 1","description":"Small amount applied and evaluated over the course of three days"},{"intervention_type":"Drug","name":"Drug: Halobetasol Propionate 0.05% Cream-Test Product 2","description":"Small amount applied and evaluated over the course of three days"}],"outcomes":[{"outcome_type":"primary","measure":"Vasoconstriction will be measured by the degree of skin blanching observed after treatment removal using a ChromaMeter","time_frame":"Over the course of three days"}]}
{"nct_id":"NCT00099411","start_date":"2004-01-31","enrollment":124,"brief_title":"Heart Muscle Viability and Remodeling in Individuals Post-Heart Attack","official_title":"Myocardial Viability and Remodeling in the Occluded Artery Trial (OAT)-Ancillary to OAT","primary_completion_date":"2007-06-30","study_type":"Observational","rec_status":"Completed","completion_date":"2007-06-30","last_update":"2017-04-27","description":"The purpose of this study is to assess the effect of heart muscle viability on left ventricular (LV) remodeling after a heart attack; to explore the relationships between retained viability of the area of tissue death (infarct zone), LV remodeling, response to the Occluded Artery Trial (OAT) intervention, and response to late percutaneous coronary intervention of the infarct related artery (IRA).","other_id":"1279","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","maximum_age":100,"population":"People who have experienced a heart attack 3 to 28 days prior to study entry.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Has experienced a heart attack 3 to 28 days prior to study entry\r\n\r\n          -  Has an occluded IRA at catheterization\r\n      ","sponsor":"Tufts Medical Center","sponsor_type":"Other","conditions":"Cardiovascular Diseases|Coronary Disease|Myocardial Infarction|Heart Diseases|Heart Failure, Congestive","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"The primary end point of LV remodeling was assessed by change in LV EDV from baseline to 1 year.","time_frame":"1 year","description":"The primary end point of LV remodeling was assessed by change in LV EDV from baseline to 1 year."}]}
{"nct_id":"NCT00234871","start_date":"2004-01-31","phase":"Phase 4","enrollment":357,"brief_title":"Tarka vs. Lotrel in Hypertensive, Diabetic Subjects With Renal Disease (TANDEM)","official_title":"A Phase IV, Randomized, Open-Label, Active Controlled Study to Compare the Effects of Tarka and Lotrel on Albuminuria in Hypertensive, Type 2 Diabetic Subjects With Diabetic Nephropathy","primary_completion_date":"2005-03-31","study_type":"Interventional","rec_status":"Completed","last_update":"2008-07-15","description":"The primary objective of this study is to determine if trandolapril/verapamil (Tarka) is superior to amlodipine/benazepril (Lotrel) in reduction of albuminuria in hypertensive subjects with Type 2 diabetes mellitus (DM) and diabetic nephropathy","other_id":"M03-599","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diabetes\r\n\r\n          -  Hypertension\r\n\r\n          -  Albuminuria\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Type 1 DM.\r\n\r\n          -  Subject has severe hepatic dysfunction at Screening as determined by liver function\r\n             tests:\r\n\r\n               -  Bilirubin > 2.0 mg/dL.\r\n\r\n               -  ALT and/or AST > 3 times the upper limit of normal.\r\n\r\n               -  Subject has poorly controlled diabetes, based on HbA1c > 10% at Screening.\r\n\r\n          -  Subject has non-diabetic renal disease.\r\n\r\n          -  Subject has a hypersensitivity to ACE inhibitor, CCB, torsemide or sulfonylureas.\r\n      ","sponsor":"Abbott","sponsor_type":"Industry","conditions":"Hypertension|Diabetes|Proteinuria","interventions":[{"intervention_type":"Drug","name":"Drug: trandolapril/verapamil","description":"2/180 mg QD with forced titration after 4 weeks to 4/240 mg QD"},{"intervention_type":"Drug","name":"Drug: Lotrel (amlodipine/benazepril)","description":"5/10 mg QD with forced titration after 4 weeks to 10/20 mg QD"}],"outcomes":[{"outcome_type":"primary","measure":"Changes in urinary albumin:creatinine ratio","time_frame":"36 weeks"},{"outcome_type":"secondary","measure":"Changes in blood pressure (BP), BP control, ABPM, proteinuria, GFR lipid parameters, glycemic control, quality of life, CRP, oxidative stress markers, clinical safety labs and adverse events.","time_frame":"36 weeks"}]}
{"nct_id":"NCT00473538","start_date":"2004-01-31","phase":"Phase 4","enrollment":40,"brief_title":"Structured Exercise Training Program Versus Hypocaloric Hyperproteic Diet in Obese Anovulatory Infertile Patients With PCOS","official_title":"Effects of Structured Exercise Program Versus Hypocaloric Hyperproteic Diet on the Reproductive Function in Obese Anovulatory Infertile Patients With Polycystic Ovary Syndrome: a 24-Week Prospective Study.","study_type":"Interventional","rec_status":"Completed","completion_date":"2006-08-31","last_update":"2007-11-14","description":"Lifestyle modifications are successfully employed in polycystic ovarian syndrome (PCOS) improving menstrual cycles and fertility. Unfortunately, the compliance over the time is very low. Recently, we have showed a high adherence to structured exercise training (SET) program in women with PCOS. The current study will be aimed to compare the efficacy of the SET program with a diet program on the reproductive function in obese anovulatory infertile PCOS patients.","other_id":"01/2004","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":35,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  PCOS\r\n\r\n          -  Anovulatory infertility\r\n\r\n          -  Obesity (BMI >30)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Age <18 or >35 years\r\n\r\n          -  Neoplastic, metabolic, hepatic, renal, and cardiovascular disorders or other\r\n             concurrent medical illnesses\r\n\r\n          -  Hypothyroidism, hyperprolactinemia, Cushing's syndrome, and non-classical congenital\r\n             adrenal hyperplasia\r\n\r\n          -  Current or previous (within the last six months) use of oral contraceptives,\r\n             glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and\r\n             anti-obesity drugs or other drugs know to affect sex hormone levels, carbohydrate\r\n             metabolism, or appetite\r\n\r\n          -  Organic pelvic diseases, previous pelvic surgery, suspected peritoneal factor\r\n             infertility, tubal or male factor infertility or sub-fertility\r\n      ","sponsor":"University Magna Graecia","sponsor_type":"Other","conditions":"Polycystic Ovary Syndrome|Anovulation|Infertility","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Structured exercise training"},{"intervention_type":"Behavioral","name":"Behavioral: Hypocaloric hyperproteic diet"}],"outcomes":[{"outcome_type":"primary","measure":"Pregnancy rate","time_frame":"six months"},{"outcome_type":"secondary","measure":"Menstrual frequency","time_frame":"six months"},{"outcome_type":"secondary","measure":"Abortion rate","time_frame":"six months"},{"outcome_type":"secondary","measure":"Compliance","time_frame":"six months"}]}
{"nct_id":"NCT00078637","start_date":"2004-01-31","phase":"Phase 1","enrollment":37,"brief_title":"Dosing and Safety Study of E7820 in Patients With a Malignant Solid Tumor or Lymphoma","official_title":"Phase I and Pharmacokinetic Study of E7820 After Oral Administration to Patients With Malignancy","primary_completion_date":"2006-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-02-28","last_update":"2014-12-23","description":"This is a first-in-man, open-label, non-randomized, multiple dose, multiple cycle, dose escalation study to determine the MTD, safety, PK, and pharmacodynamics of E7820 in patients with a malignant solid tumor or lymphoma.","other_id":"E7820-A001-102","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients must have a histologically or cytologically confirmed malignant solid tumor\r\n             or lymphoma. Malignancy must be advanced and require systemic therapy. Malignancy must\r\n             be one for which no standard therapy is available or the patient must not be a\r\n             candidate for standard therapy.\r\n\r\n          -  Patients must have a Karnofsky Performance Status of >= 70%,\r\n\r\n          -  Patients must have a life expectancy of >= 3 months,\r\n\r\n          -  Patients must be aged >= 18 years,\r\n\r\n          -  Patients must have adequate renal function as evidenced by serum creatinine <= 1.5\r\n             mg/dL or creatinine clearance >= 60 mL/minute/1.73m2,\r\n\r\n          -  Patients must have adequate bone marrow function as evidenced by ANC >= 1,500 mm3 and\r\n             platelets >= 100,000 mm3, must have adequate liver function as evidenced by bilirubin\r\n             <= 1.5 mg/dL and alanine transaminase (ALAT) and aspartate transaminase (ASAT) <= 2.5\r\n             times the upper limits of normal (ULN) (unless related to liver metastases in which\r\n             case <= 5 x ULN),\r\n\r\n          -  Patients must be willing and able to comply with the study protocol for the duration\r\n             of the study, and\r\n\r\n          -  Patients must give written informed consent prior to any study-specific screening\r\n             procedures with the understanding that the patient may withdraw consent at any time\r\n             without prejudice.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who have a history of previous hypersensitivity to sulfonamide derivatives,\r\n             Patients who have received chemotherapy within 4 weeks (6 weeks if nitrosoureas were\r\n             received) of commencing study treatment,\r\n\r\n          -  Patients who have had radiation to >= 25% of their bone marrow (e.g., pelvic\r\n             radiation) within 4 weeks of E7820 treatment,\r\n\r\n          -  Patients who have not recovered from any clinically significant chemotherapy or\r\n             radiotherapy related toxicity at study entry.\r\n\r\n          -  Patients who have received investigational drugs or other antineoplastic therapy\r\n             within 28 days of E7820 treatment,\r\n\r\n          -  Patients who have had major surgery within 4 weeks of study drug administration,\r\n\r\n          -  Women who are pregnant or breast-feeding. -- Women of childbearing potential with\r\n             either a positive pregnancy test at screening or no pregnancy test. Women of\r\n             childbearing potential unless (1) surgically sterile or (2) using adequate measures of\r\n             contraception in the opinion of the Investigator (postmenopausal women must be\r\n             amenorrheic for at least 12 months to be considered of non-childbearing potential),\r\n\r\n          -  Fertile men and fertile women who are not willing to use contraception or fertile men\r\n             or fertile women with a partner who is not willing to use contraception,\r\n\r\n          -  Patients with active central nervous system (CNS) metastases (i.e., evidence of\r\n             progressive clinical symptoms, edema requiring corticosteroids, or tumors exhibiting\r\n             growth on sequential MRI or CT scans),\r\n\r\n          -  Patients who are known to be positive for hepatitis B surface antigen, hepatitis B\r\n             core antibody, hepatitis C antibody, or human immunodeficiency virus,\r\n\r\n          -  Patients with severe uncontrolled intercurrent illness/infection (excluding\r\n             malignancies),\r\n\r\n          -  Patients with a history of unstable ischemic disease,\r\n\r\n          -  Patients with a history of clinically significant thrombosis,\r\n\r\n          -  Patients receiving antithrombotic (including aspirin) or therapeutic anticoagulant\r\n             therapy (prior to study entry, patients receiving these types of drugs must have been\r\n             off therapy for at least 7 days),\r\n\r\n          -  Patients with a history of documented vascular headache with neurological changes,\r\n\r\n          -  Patients < 30% of ideal weight for height and age according to the Metropolitan Life\r\n             Insurance Company Statistical Bulletin, or\r\n\r\n          -  Patients with significant disease, or any condition, which in the Investigator's\r\n             opinion would exclude the patient from the study, or\r\n\r\n          -  Patients who have pulmonary disease that puts them at risk of hemoptysis.\r\n      ","sponsor":"Eisai Inc.","sponsor_type":"Industry","conditions":"Neoplasms|Lymphoma, Malignant","interventions":[{"intervention_type":"Drug","name":"Drug: E7820"}],"outcomes":{}}
{"nct_id":"NCT00149227","start_date":"2004-01-31","phase":"Phase 4","enrollment":3031,"brief_title":"Add-on Effects of Valsartan on Morbi- Mortality (KYOTO HEART Study)","official_title":"Add-on Effects of Valsartan on Morbi- Mortality in High Risk Hypertension","primary_completion_date":"2009-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-01-31","last_update":"2012-12-12","description":"The KYOTO HEART Study is to assess the add-on effect of valsartan, an Angiotensin-Receptor Blocker, on top of the conventional treatment in high risk patients in Japan with hypertension in terms of the morbidity and mortality.","other_id":"KHS2004","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":79,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Clinical diagnosis of hypertension\r\n\r\n          -  Clinical diagnosis of one or more risk factors, such as diabetes, smoking habit, lipid\r\n             metabolism abnormality, history of ischemic heart disease (IHD) or cerebrovascular\r\n             disease, obesity (BMI>25), chronic heart failure (NYHA II-III), and electrocardiogram\r\n             (ECG) abnormality (LVH)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who have already been administered ARB\r\n\r\n          -  Patients with IHD within 6 months after percutaneous coronary intervention(PCI), and\r\n             who are stable but are going to implement PCI or coronary artery bypass grafting(CABG)\r\n\r\n          -  Severe/malignant/secondary hypertensive patients\r\n\r\n          -  Pregnant women and women of childbearing potential\r\n\r\n          -  History of heart failure, unstable angina, myocardial infarction, PTCA, or CABG within\r\n             the preceding 6 months\r\n\r\n          -  Arrhythmia needed to be treated or accompanied with symptoms, second or third degree\r\n             AV block\r\n\r\n          -  Severe renal impairment (Serum creatinine >3.0 mg/dl)\r\n\r\n          -  Severe hepatic impairment (Hepatic failure, Cirrhosis, etc.)\r\n      ","sponsor":"Kyoto Prefectural University of Medicine","sponsor_type":"Other","conditions":"Hypertension|Ischemic Heart Disease|Congestive Heart Failure|Stroke","interventions":[{"intervention_type":"Drug","name":"Drug: Valsartan","description":"Valsartan add-on arm: valsartan 40-160 mg per day, and an additional antihypertensive drugs other than ARB and ACEI are administered if necessary."},{"intervention_type":"Drug","name":"Drug: Non-ARB","description":"'Non-ARB' was defined conventional anti-hypertensive treatment except for ACEIs and ARBs"}],"outcomes":[{"outcome_type":"primary","measure":"New Onset or Recurrence of Stroke","time_frame":"five years","description":"Stroke events included brain hemorrhage, infarction, and TIA. They required hospitalization with neurological symptoms and were diagnosed by CT and/or MRI. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical significance with a two-tailed 5% statistical significant level."},{"outcome_type":"primary","measure":"New Onset or Recurrence of Transient Ischemic Attack","time_frame":"five years","description":"Transient ischemic attack (TIA) was defined as hospitalization with sudden onset of neurological deficit persisting for less than 24 hrs, and without abnormal findings using by CT and/or MRI. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical significance with a two-tailed 5% statistical significant level."},{"outcome_type":"primary","measure":"New Onset or Recurrence of Acute Myocardial Infarction","time_frame":"five years","description":"Acute myocardial infarction was diagnosed with hospitalization, ECG- change, and biomarkers for myocardial infarction. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical significance with a two-tailed 5% statistical significant level."},{"outcome_type":"primary","measure":"Hospitalization Due to the New Onset, Recurrence or Worsening of Heart Failure and Additional Concomitant Use of Other Anti-heart Failure Agents or Increase of Dosage","time_frame":"five years","description":"Heart failure event was defined as requiring hospitalization and clinical symptoms together with left ventricular dysfunction by echocardiography according to the guidelines of the AHA/ACC. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical significance with a two-tailed 5% statistical significant level."},{"outcome_type":"primary","measure":"Hospitalization Due to the New Onset, Occurrence or Worsening of Angina Pectoris and Additional Concomitant Use of Other Anti-anginal Agents or Increase of Dosage","time_frame":"five years","description":"Angina pectoris event required hospitalization and was diagnosed by both ECG changes corresponding with chest symptoms and coronary angiography showing 75% stenosis according to AHA/ACC guidelines. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical significance with a two-tailed 5% statistical significant level."},{"outcome_type":"primary","measure":"Operation of PCI or Bypass Operation","time_frame":"five years"},{"outcome_type":"primary","measure":"New Onset of Acute Dissecting Aneurysm of the Aorta","time_frame":"five years","description":"Dissecting aneurysm of the aorta required hospitalization and was diagnosed by imaging technique, CT and/or MRI. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical significance with a two-tailed 5% statistical significant level."},{"outcome_type":"primary","measure":"New Onset, Recurrence or Worsening of Arteriosclerosis Obliterans","time_frame":"five years","description":"Arteriosclerosis obliterans (ASO) event was diagnosed with symptoms and CT / MRI imaging. The first of any of these events to occur in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical significance with a two-tailed 5% statistical significant level."},{"outcome_type":"primary","measure":"Transition to Dialysis, Doubling of Plasma Cr Levels","time_frame":"five years","description":"The first of any events, \"transition to dialysis\" or \"doubling of plasma Cr levels compared to the entry\", occurring in a specific patient was classified as an event to be counted in the primary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical significance with a two-tailed 5% statistical significant level."},{"outcome_type":"secondary","measure":"All Cause Mortality","time_frame":"five years"},{"outcome_type":"secondary","measure":"Worsening of Cardiac Function","time_frame":"five years"},{"outcome_type":"secondary","measure":"New Onset or Worsening of Arrhythmias","time_frame":"five years"},{"outcome_type":"secondary","measure":"New Onset or Worsening of Diabetes Mellitus or IGT","time_frame":"five years","description":"Diabetes mellitus was defined as fasting plasma glucose >=126 mg/dl, causal blood glucose >= 200 mg /dl, HbA1C >= 6.5%, and/or plasma glucose 2hr after 75g glucose load >= 200 mg/dl. The first of these events, \"new onset diabetes\" or \"worsening diabetes following IGT\", occurring in a specific patient was classified as an event to be counted in the secondary endpoint by the Endpoint Committee. We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical significance with a two-tailed 5% statistical significant level."},{"outcome_type":"secondary","measure":"Uncontrolled Blood Pressure, Etc.","time_frame":"five years"}]}
{"nct_id":"NCT00120185","start_date":"2003-12-31","phase":"Phase 2","enrollment":130,"brief_title":"Efficacy of Using Interleukin-2 in Antiretroviral Nave HIV Patients (ANRS119)","official_title":"Study of the Immunological Efficacy of Using Subcutaneous Interleukin-2 (IL-2) in Antiretroviral Nave HIV-1-Infected Subjects With a CD4 Cell Count Above 300/mm3. ANRS 119 Trial INTERSTART","primary_completion_date":"2006-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2006-11-30","last_update":"2011-12-22","description":"Interleukin-2 (IL-2) increases the number of CD4 cells in HIV-1 infected patients under highly active antiretroviral therapy (HAART) with a CD4 cell count over 200/mm3, but its activity in patients without antiretroviral therapy is unknown. This study will test the efficacy and safety of IL-2 in nave patients with a CD4 count between 300 and 500/m3.","other_id":"2004-003897-27","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adult patients with proven HIV-1-infection\r\n\r\n          -  No prior exposition to antiretrovirals\r\n\r\n          -  CD4 cell count between 300 and 500/mm3\r\n\r\n          -  Signed written inform consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnancy\r\n      ","sponsor":"French National Agency for Research on AIDS and Viral Hepatitis","sponsor_type":"Other","conditions":"HIV Infections","interventions":[{"intervention_type":"Drug","name":"Drug: Interleukin-2"}],"outcomes":[{"outcome_type":"primary","measure":"Proportion of patients reaching an absolute CD4 count below 300/mm3 at W96"},{"outcome_type":"secondary","measure":"Group B or C events (1993 CDC classification of HIV infection)"},{"outcome_type":"secondary","measure":"Initiation of antiretroviral therapy"},{"outcome_type":"secondary","measure":"Evolution of the CD4 count during the study"},{"outcome_type":"secondary","measure":"Time to the first visit with a CD4 count below 300/mm3"},{"outcome_type":"secondary","measure":"Tolerance of IL-2"},{"outcome_type":"secondary","measure":"Evolution of the plasma HIV RNA load"},{"outcome_type":"secondary","measure":"Evolution of the HIV DNA level in PBMCs"},{"outcome_type":"secondary","measure":"Quality of life at W96"},{"outcome_type":"secondary","measure":"Assessment of lipodystrophy at W96"},{"outcome_type":"secondary","measure":"Immunological substudies (CD4 homeostasis, anti HIV cellular immune responses) at W96"}]}
{"nct_id":"NCT00175292","start_date":"2003-12-31","phase":"Phase 3","enrollment":120,"brief_title":"A Randomized Controlled Trial of VSL#3 for the Prevention of Endoscopic Recurrence Following Surgery for Crohn's Disease.","official_title":"A Randomized and Placebo-Controlled Double-Blind Multicentre Study to Determine the Efficacy and Safety of VSL#3 Probiotic Food Supplement Mixture in Prevention of Endoscopic Recurrence in Crohn's Disease Patients With Ileocolonic Surgical Resection and Small Intestine to Colon Anastomosis.","study_type":"Interventional","rec_status":"Completed","last_update":"2008-05-14","description":"This randomized placebo-controlled double-blind, multi-centre trial will determine the efficacy of the probiotic VSL#3 in the prevention of Crohn's disease development following surgical resection and re-anastomosis. A total of 120 patients will be randomly assigned in a 1:1 ratio to receive VSL#3 or placebo for 90 days. Patients who respond to study treatment, as defined by the absence of a severe endoscopic recurrence at day 90, will be offered open-label VSL#3 for an additional 9 months.","other_id":"VSL-FED-01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":16,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Subjects 16 years of age or older\r\n\r\n          2. Diagnosis of Crohn's disease\r\n\r\n          3. Resection of ileocolonic Crohn's disease and small bowel to colonic anastomosis within\r\n             30 days of randomization\r\n\r\n          4. Able to provide informed written consent\r\n\r\n          5. Women of child-bearing potential with a negative serum pregnancy test, and/or use of\r\n             effective contraception\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Use of perioperative steroids in tapering doses and anti-diarrheal agents\r\n\r\n          2. Treatment with a TNF-antagonist in the 8 weeks prior to resection\r\n\r\n          3. Clinically significant Crohn's disease elsewhere in the GI tract\r\n\r\n          4. Clinically documented short bowel syndrome\r\n\r\n          5. Serious disease other than Crohn's disease\r\n\r\n          6. Impaired liver or renal function\r\n\r\n          7. History of cancer with less than 2 years disease-free state\r\n\r\n          8. Abnormal Laboratory values\r\n\r\n          9. Alcohol or drug abuse\r\n\r\n         10. Some psychiatric conditions\r\n\r\n         11. Patients using other study medications\r\n\r\n         12. Patients who are unable to attend study visits or comply with study procedures\r\n\r\n         13. Positive pregnancy test\r\n      ","sponsor":"University of Alberta","sponsor_type":"Other","conditions":"Crohn's Disease|Inflammatory Bowel Disease","interventions":[{"intervention_type":"Drug","name":"Drug: Probiotic - VSL#3"}],"outcomes":[{"outcome_type":"primary","measure":"Prevention of severe endoscopic recurrence of Crohn's disease."},{"outcome_type":"secondary","measure":"Endoscopic recurrence at 90 days and 360 days"},{"outcome_type":"secondary","measure":"Crohn's Disease Activity Index (CDAI)"},{"outcome_type":"secondary","measure":"Quality of life"},{"outcome_type":"secondary","measure":"Safety and tolerance of VSL#3"}]}
{"nct_id":"NCT00168961","start_date":"2003-12-31","phase":"Phase 4","brief_title":"Enteral Nutrition in Liver Cirrhosis","primary_completion_date":"2006-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-06-30","last_update":"2010-05-07","description":"Malnutrition is frequently occurring in patients with liver cirrhosis and is associated with a poorer outcome, as it determines life quality and affects both morbidity and mortality. Long term prognosis after liver transplantation also depends on the nutritional status. Therefore, the early diagnosis and intervention for malnutrition is an important issue in the clinical management of liver cirrhosis. However, oral intake has been shown to be insufficient due to disease related anorexia or concomitant drowsiness and confusion. Specific aims: To investigate the effect of early nutritional intervention via tube feeding on nutritional status, functional status (hand grip strength and peak flow), life quality and disease related complications such as intestinal permeability, and oxidative stress, as well as liver function.","other_id":"EE1","allocation":"Randomized","intervention_model":"Parallel Assignment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Liver cirrhosis (Child B or Child C)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Malignant comorbidity\r\n\r\n          -  Encephalopathy\r\n      ","sponsor":"Charite University, Berlin, Germany","sponsor_type":"Other","conditions":"Liver Cirrhosis","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: High Protein Energy, Fresenius-Kabi (nutritional intervention)"}],"outcomes":{}}
{"nct_id":"NCT00447707","start_date":"2003-12-31","phase":"N/A","enrollment":497,"brief_title":"Positive Choice: Prevention for Positive Health","official_title":"Positive Choice: Prevention for Positive Health","study_type":"Interventional","rec_status":"Completed","completion_date":"2006-09-30","last_update":"2017-01-12","description":"This is a randomized, controlled trial of Positive Choice, an interactive multimedia computer program, to determine whether it can detect and reduce risky behaviors among HIV-positive adults. The behaviors of interest are: unprotected anal or vaginal intercourse, illicit drug use, risky alcohol drinking, and failure to disclose HIV status to sex partners. The Positive Choice program is integrated into the routine operations of outpatient HIV clinics, where participating patients complete an in-depth risk assessment (computerized health questionnaire) before a regularly scheduled medical appointment. Participants assigned to the intervention arm receive brief, interactive risk-reduction counseling by an actor-portrayed Video Doctor and an educational worksheet. Their health care provider receives as summary cueing sheet, alerting them to the patient's risky behavior and readiness to change. Control participants complete the computerized risk assessment and receive the clinic's usual care. Three months after a baseline visit, intervention and control group patients are invited back to complete an additional risk assessment. The intervention group also receives a \"booster\" intervention. Six months after baseline, both groups complete a final risk assessment.","other_id":"R01DA015016","allocation":"Randomized","intervention_model":"Parallel Assignment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  18 years or older,\r\n\r\n          -  HIV-positive 3 months or longer,\r\n\r\n          -  English speaking; and\r\n\r\n          -  Receiving medical care at a participating clinic.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Less than 18 years old,\r\n\r\n          -  HIV-positive less than 3 months,\r\n\r\n          -  Non-English speaking; and\r\n\r\n          -  Not receiving medical care at a participating clinic.\r\n      ","sponsor":"National Institute on Drug Abuse (NIDA)","sponsor_type":"NIH","conditions":"HIV Infections|Sexual Risk Behavior|Substance Use Risks","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Positive Choice"}],"outcomes":[{"outcome_type":"primary","measure":"Elimination of risky drinking, illicit alcohol use, unprotected sex, and non-disclosure of HIV status to sex partners."},{"outcome_type":"secondary","measure":"Measures of change in risky alcohol use, illicit drug use, unprotected sex, and non-disclosure of HIV status to sex partners."}]}
{"nct_id":"NCT00113048","start_date":"2003-12-31","phase":"Phase 1","enrollment":24,"brief_title":"Subcutaneously Administered CAMPATH in CD52 Expressing Hematologic Malignancies","official_title":"A Phase I Study of Subcutaneously Administered CAMPATH in CD52 Expressing Hematologic Malignancies","study_type":"Interventional","rec_status":"Terminated","completion_date":"2005-09-30","last_update":"2014-02-05","description":"This phase I study will involve escalating doses of CAMPATH until the goal dose for the cohort is tolerated. The CAMPATH goal dose will be administered to the patient subcutaneously (SQ) 3 times per week for up to 12 weeks.","other_id":"CAM111","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with relapsed or refractory hematologic malignancy. The anticipated patient\r\n             population are patients with chronic lymphocytic leukemia (CLL), non-Hodgkin's\r\n             lymphoma or myeloma\r\n\r\n          -  Patients with a history of a hematologic malignancy that has previously been shown by\r\n             flow cytometry or immunophenotyping analysis to express CD52\r\n\r\n          -  Any chemotherapy, major surgery or irradiation must have been completed at least four\r\n             (4) weeks before enrollment in this study (6 weeks for mitomycin-C or nitrosourea)\r\n\r\n          -  Patients have recovered from the acute side effects due to prior therapy\r\n\r\n          -  Life expectancy of > 3 months\r\n\r\n          -  World Health Organization (WHO) Performance Status 0-2\r\n\r\n          -  18 years of age or older\r\n\r\n          -  Adequate organ function as defined in the protocol\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior therapy with CAMPATH\r\n\r\n          -  Use of an investigational agent within two (2) weeks prior to study enrollment\r\n\r\n          -  History of anaphylaxis following exposure to humanized monoclonal antibodies\r\n\r\n          -  Known human immunodeficiency virus (HIV) positive\r\n\r\n          -  Prior autologous bone marrow or stem cell transplant if within six (6) months of study\r\n             entry\r\n\r\n          -  A history or prior allogenic bone marrow transplant or organ transplant\r\n\r\n          -  Known, symptomatic central nervous system (CNS) involvement with lymphoma\r\n\r\n          -  Pregnant or lactating women\r\n\r\n          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active\r\n             infection (excluding skin infection, lower urinary tract infection, or oral\r\n             infection), symptomatic congestive heart failure, unstable angina pectoris, cardiac\r\n             arrhythmia, or psychiatric illness/social situations that would limit compliance with\r\n             study requirements\r\n      ","sponsor":"Genzyme, a Sanofi Company","sponsor_type":"Industry","conditions":"Hematologic Malignancies","interventions":[{"intervention_type":"Drug","name":"Drug: CAMPATH (alemtuzumab)"}],"outcomes":{}}
{"nct_id":"NCT00170833","start_date":"2003-11-30","phase":"Phase 3","enrollment":80,"brief_title":"Safety, Tolerability and Efficacy of Everolimus With Lower Versus Higher Levels of Tacrolimus in de Novo Renal Transplant Patients","official_title":"A Prospective, Multicenter, Open Label, Randomized Study of the Safety, Tolerability and Efficacy of Everolimus (RAD001) With Basiliximab, Corticosteroids and Lower Levels Versus Higher Levels of Tacrolimus in de Novo Renal Transplant Recipients","primary_completion_date":"2005-11-30","study_type":"Interventional","rec_status":"Completed","last_update":"2011-11-02","description":"This study will assess the safety and efficacy of everolimus with basiliximab, corticosteroids and lower levels versus higher levels of tacrolimus in de novo renal transplant recipients.","other_id":"CRAD001AUS09","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female patients between 18 and 65 years of age\r\n\r\n          -  Male or female patients who are primary cadaveric, living unrelated or non-HLA\r\n             identical living related donor renal transplant recipients\r\n\r\n          -  The renal cold ischemic time (CIT) must be < 30 hours\r\n\r\n          -  The age of the donor must be between 10 and 59 years and not meet UNOS expanded donor\r\n             criteria\r\n\r\n        Exclusion criteria\r\n\r\n          -  Patients meeting any of the following criteria at baseline will be excluded from study\r\n             participation.\r\n\r\n          -  Patients who have previously received an organ transplant\r\n\r\n          -  Patients who are recipients of a multiple organ transplants\r\n\r\n          -  Recipients of non heart-beating donor organs\r\n\r\n        Other protocol define inclusion/exclusion criteria may apply. Patients who are recipients\r\n        of A-B-O incompatible transplants or T-cell crossmatch positive transplants Patients with\r\n        current panel reactive T-cell antibodies (PRA) titers of 50% or more (when the test is\r\n        performed with dithiothreitol treated patient's serum) Patients who are known to have a\r\n        positive hepatitis C serology, who are human immunodeficiency virus (HIV) or Hepatitis B\r\n        surface antigen positive. Laboratory results obtained within 6 months prior to first dose\r\n        of everolimus are acceptable. Recipients of organs from donors who test positive for\r\n        Hepatitis B surface antigen or Hepatitis C are excluded Presence of cardiac disease ( Old\r\n        New York Heart Association Classification Grade 3, elevated creatine phosphokinase\r\n        myocardial binding isoenzyme (CPK-MB)or any cardiac disease considered to be unsafe for the\r\n        study by the investigator) 10.Presence of severe hypercholesterolemia ( 350 mg/dL, 9.1\r\n        mmoL/dL) or hypertriglyceridemia ( 500mg/dL, 5.6 mmoL/L). Patients with controlled\r\n        hyperlipidemia are acceptable 11.White blood cell (WBC) count 4500/mm3, or platelet count\r\n        100,000/mm3 12.Evidence of liver injury as indicated by an abnormal liver profile (AST,\r\n        ALT, alkaline phosphatase or total bilirubin 3 times ULN) before transplantation\r\n        13.Presence of any severe allergy requiring acute (within 4 weeks of baseline) or chronic\r\n        treatment, or hypersensitivity to drugs similar to everolimus (e.g., macrolides) 14.The use\r\n        of any investigational drug within 4 weeks of the baseline period 15.Patients who have been\r\n        treated with non-protocol immunosuppressive drug or treatment within 1 month prior to first\r\n        dose of everolimus 16.Patients with severe systemic infections 17.Existence of any surgical\r\n        or medical condition, other than the current transplant, which in the opinion of the\r\n        investigator, preclude enrollment in this trial 18.Malignancy (current or history within\r\n        last 5 years) except for successfully treated localized basal or squamous cell carcinoma of\r\n        the skin 19.Patients with any medical condition requiring long-term anticoagulation, such\r\n        as heparin, low molecular weight heparin, or warfarin, after transplantation (Low dose\r\n        aspirin, clopidogrel, or cilostazol treatment is allowed) 20.Abnormal physical or\r\n        laboratory findings of clinical significance within 2 weeks prior to first dose of\r\n        everolimus which at investigators discretion would interfere with the objectives of the\r\n        study 21.Breast feeding women 22.Patients with symptoms of significant somatic or mental\r\n        illness. Unresolved history of drug or alcohol abuse 23.Inability to cooperate or\r\n        communicate with the investigator 24.Donors that meet the UNOS expanded donor criteria\r\n      ","sponsor":"Novartis Pharmaceuticals","sponsor_type":"Industry","conditions":"Renal Transplantation","interventions":[{"intervention_type":"Drug","name":"Drug: Everolimus"}],"outcomes":[{"outcome_type":"primary","measure":"renal function as measured by serum creatinine at 6 months post-transplant"},{"outcome_type":"secondary","measure":"Renal function as measured by calculated creatinine clearance and calculated glomerular filtration rate at 6 months"},{"outcome_type":"secondary","measure":"Occurrence of biopsy-proven acute rejection at 6 months post-transplant"},{"outcome_type":"secondary","measure":"Combined and individual incidence of biopsy-proven acute rejection episodes, graft loss, and death at 6 months"},{"outcome_type":"secondary","measure":"Incidence of adverse events and serious adverse events"},{"outcome_type":"secondary","measure":"Incidence of New Onset Diabetes post-transplant at 3 and 6 months"}]}
{"nct_id":"NCT00485914","start_date":"2003-10-31","phase":"N/A","enrollment":89,"brief_title":"Work Interventions to Improve Employment Outcomes for Persons With Rheumatoid Arthritis and Osteoarthritis","official_title":"Worksite Vocational Rehabilitation Intervention to Improve Employment Outcomes for Persons With Arthritis?","primary_completion_date":"2009-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-09-30","last_update":"2016-10-04","description":"To determine if worksite based functional evaluation/intervention provided by occupational therapists improves employment outcomes for persons with arthritis.","other_id":"H133B031120-Project 3","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Rheumatoid arthritis or osteoarthritis diagnosed by a rheumatologist\r\n\r\n          -  Competitively employed; full or part time\r\n\r\n          -  Reporting arthritis-related employment difficulties\r\n\r\n          -  Agree to participate in a work site evaluation\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Systemic complications of RA (e.g., vasculitis)\r\n\r\n          -  Organic Brain Syndrome\r\n\r\n          -  Uncontrolled psychiatric disorders\r\n\r\n          -  Uncontrolled medical conditions (e.g., active cancer)\r\n      ","sponsor":"University of Missouri-Columbia","sponsor_type":"Other","conditions":"Osteoarthritis|Rheumatoid Arthritis","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: On-site work evaluation","description":"Researchers will measure the effects of worksite assessment through an on-site work evaluation by an occupational therapist on a person's job satisfaction, capacity to perform work duties, income, health status, and psychological well-being. The scope of the information will be through one-to-one contact and an individualized work plan. The strategies will include recommendations for work behaviors, ergonomic and body mechanics considerations, and modifications for job tasks, equipment, and space."},{"intervention_type":"Behavioral","name":"Behavioral: Educational material","description":"Researchers will measure the effects of worksite assessment through educational materials on a person's job satisfaction, capacity to perform work duties, income, health status, and psychological well-being. The scope of the information will be through educational materials to develop strategies to compensate. The strategies will include recommendations for work behaviors, ergonomic and body mechanics considerations, and modifications for job tasks, equipment, and space."}],"outcomes":[{"outcome_type":"primary","measure":"Arthritis Impact Measurement Scale-2, Brief Symptom Inventory, Job Satisfaction Survey, Occupational Data information, Work History, Employment Status, Financial Information","time_frame":"Scores at baseline, 3, 6, 12, 24 months"}]}
{"nct_id":"NCT00269308","start_date":"2003-10-31","phase":"Phase 2","enrollment":241,"brief_title":"Chiropractic and Exercise for Seniors With Neck Pain","official_title":"Randomized Clinical Trial of Chiropractic Manual Therapy Plus Home Exercise, Supervised Exercise Plus Home Exercise and Home Exercise Alone For Individual 65 and Over With Chronic Mechanical Neck Pain","primary_completion_date":"2008-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-04-30","last_update":"2011-08-23","description":"The purpose of this randomized clinical trial is to assess the relative effectiveness of three conservative treatment approaches for seniors with chronic neck pain: 1) chiropractic manual treatment plus home exercise, 2) supervised exercise plus home exercise and 3) home exercise alone.","other_id":"R18HP01425","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Chronic neck pain (Defined as current episode more than 12 weeks duration.)\r\n\r\n          -  Quebec Task Force classifications 1, 2, 3 and 4. This includes patients with neck\r\n             pain, stiffness or tenderness, with or without musculoskeletal and neurological signs.\r\n\r\n          -  65 years of age and older\r\n\r\n          -  Independent ambulation\r\n\r\n          -  Community dwelling (residency outside nursing home)\r\n\r\n          -  Score of 20 or more on Folstein Mini-Mental State Examination\r\n\r\n          -  Stable prescription medication plan (no changes in prescription medications that\r\n             affect musculoskeletal pain in previous month)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Referred neck pain from local joint lesions of the upper extremities or from visceral\r\n             diseases\r\n\r\n          -  Significant infectious disease\r\n\r\n          -  Ongoing treatment for neck pain by other health care providers\r\n\r\n          -  Mean neck pain score of less than 20 percentage points\r\n\r\n          -  Contraindications to exercise Determined by history or by referral to supplementary\r\n             diagnostic tests (i.e., uncontrolled arrhythmias, third degree heart block, recent ECG\r\n             changes, unstable angina, acute myocardial infarction, acute congestive heart failure,\r\n             cardiomyopathy, valvular heart disease, poorly controlled blood pressure, uncontrolled\r\n             metabolic disease)\r\n\r\n          -  Contraindications to spinal manipulation (i.e. Progressive neurological deficits,\r\n             blood clotting disorders, severe osteoporosis, infectious and non-infectious\r\n             inflammatory or destructive tissue changes of the spine)\r\n      ","sponsor":"Northwestern Health Sciences University","sponsor_type":"Other","conditions":"Neck Pain","interventions":[{"intervention_type":"Procedure","name":"Procedure: Chiropractic Manual treatment + home exercise ( procedure+behavior)","description":"The number of treatments will be determined by the individual chiropractor. Chiropractic manual treatment will be limited to gentle spinal manipulation and mobilization with light soft tissue massage as indicated to facilitate the manual therapy.\r\nPatients will attend 4, 1-hour small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about neck pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active"},{"intervention_type":"Procedure","name":"Procedure: Supervised rehabilitative exercise + home exercise","description":"The rehabilitative exercise program will consist of 20, 1 hour small-group sessions. It is a modification of exercise protocols used in previous studies by the investigators and others and incorporates recommendations of leading rehabilitative exercise specialists. The program will include exercises that reduce joint stiffness and relax elastic structures resulting in lower joint loads during movements.\r\nPatients will attend 4, 1-hour small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about neck pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active"},{"intervention_type":"Behavioral","name":"Behavioral: Home exercise","description":"Patients will attend 4, 1-hour small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about neck pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active."}],"outcomes":[{"outcome_type":"primary","measure":"Patient-rated pain (0-10 scale, 11 box)","time_frame":"short term = 12 weeks; long term = 52 weeks"},{"outcome_type":"secondary","measure":"General Health","time_frame":"short term = 12 weeks; long term = 52 weeks"},{"outcome_type":"secondary","measure":"Disability","time_frame":"short term = 12 weeks; long term = 52 weeks"},{"outcome_type":"secondary","measure":"Improvement","time_frame":"short term = 12 weeks; long term = 52 weeks"},{"outcome_type":"secondary","measure":"Satisfaction","time_frame":"short term = 12 weeks; long term = 52 weeks"},{"outcome_type":"secondary","measure":"Medication use","time_frame":"short term = 12 weeks; long term = 52 weeks"},{"outcome_type":"secondary","measure":"Biomechanical tests: Cervical spine motion, Strength and Endurance, Functional Ability, Observed Pain Behavior","time_frame":"short term = 12 weeks"}]}
{"nct_id":"NCT00071760","start_date":"2003-10-31","phase":"Phase 2","enrollment":75,"brief_title":"Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects","official_title":"A 48 Week, Phase II, Open-label, 2-cohort, Multicenter Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Antiviral Activity of GW433908 and GW433908/RTV When Administered to HIV-1 Infected Protease Inhibitor (PI) Naive and PI-experienced Pediatric Subjects Aged 4 Weeks to <2 Years.","primary_completion_date":"2011-07-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2021-06-30","last_update":"2017-01-13","description":"This is a 48-week study to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen including FDA approved HIV drugs in HIV-infected pediatric subjects, ages 4 weeks to < 2 years old.","other_id":"APV20002","allocation":"Non-Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","maximum_age":2,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female 4 weeks to <2 years of age. Cohort 1 (6 months - <2 years): Subjects\r\n             must be <2 years of age at the Week 2 visit therefore the maximum age at screening is\r\n             22 months.\r\n\r\n        Cohort 2 (4 weeks - <6 months): Subjects must be <6 months of age at the Week 2 visit,\r\n        therefore the maximum age at screening is 4 months for entry into this cohort.\r\n\r\n          -  Parent or legal guardian is willing and able to provide written informed consent for\r\n             the subject to participate in the trial.\r\n\r\n          -  Screening plasma HIV-1 RNA level >=400copies/mL.\r\n\r\n          -  Subjects who, in the investigator's opinion, and following viral resistance testing if\r\n             conducted, are able to construct an active Nucleoside Reverse Transcriptase Inhibitor\r\n             (NRTI) backbone regimen consisting of 2 NRTIs.\r\n\r\n          -  Subjects must meet one of the following criteria:\r\n\r\n        Therapy-nave or PI-nave subjects (defined as having received less than one week of any\r\n        PI).\r\n\r\n        PI-experienced subjects defined as having prior experience with no more than three PIs.\r\n        Prior RTV-boosted PI therapy will be considered as only one PI as long as the RTV dose was\r\n        lower than that recommended for use of RTV as an antiretroviral agent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior history of having received APV.\r\n\r\n          -  Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) therapy within 14 days prior to\r\n             study drug administration (single or multiple dose) or anticipated need for concurrent\r\n             NNRTI therapy during the study period.\r\n\r\n          -  PI therapy within 5 days prior to study drug administration (applicable only for\r\n             subjects undergoing single dose visits)\r\n\r\n          -  Subjects and/or parents/legal guardians who, in the investigator's opinion, are not\r\n             able to comply with the requirements of the study.\r\n\r\n          -  Subject is in the initial acute phase of a Centers for Disease Control and Prevention\r\n             (CDC) Clinical Category C event or infection (per 1994 classification) at Baseline.\r\n             Subject may be enrolled provided they are receiving treatment for the infections, such\r\n             treatment not being contraindicated with FPV, and subjects are clinically improving at\r\n             the Baseline visit.\r\n\r\n          -  Presence of a malabsorption syndrome or other gastrointestinal dysfunction which might\r\n             interfere with drug absorption or render the subject unable to take oral medication.\r\n\r\n          -  Presence of any serious medical condition (e.g., hemoglobinopathy, chronic anemia,\r\n             diabetes, cardiac dysfunction, hepatitis, or clinically relevant pancreatitis) which,\r\n             in the opinion of the investigator, might compromise the safety of the subject.\r\n\r\n          -  Any acute laboratory abnormality at screen which, in the opinion of the investigator,\r\n             should preclude the subject's participation in the study of an investigational\r\n             compound. If subjects are found to have an acute Grade 4 laboratory abnormality at\r\n             screening, this test may be repeated once within the screening window. Any verified\r\n             Grade 4 laboratory abnormality would exclude a subject from study participation.\r\n\r\n          -  Grade 3 or higher (>10x ULN) serum aminotransferase levels (alanine aminotransferase,\r\n             ALT and/or aspartate aminotransferase, AST) within 28 days prior to study drug\r\n             administration and / or clinically relevant hepatitis within the previous 6 months.\r\n\r\n          -  Treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days\r\n             of study drug administration or an anticipated need for such treatment within the\r\n             study period.\r\n\r\n          -  Treatment with immunomodulating agents (e.g., systemic corticosteroids, interleukins,\r\n             interferons) or any agent with known anti-HIV activity (e.g., hydroxyurea or\r\n             foscarnet) within 28 days of study drug administration.\r\n\r\n          -  Treatment with any of the following medications within 28 days prior to receiving\r\n             study medication or the anticipated need during the study:\r\n\r\n        Amiodarone, astemizole, bepridil, bupropion, cisapride, clorazepate, clozapine, diazepam,\r\n        dihydroergotamine, encainide, ergonovine, ergotamine, estazolam, flecainide, flurazepam,\r\n        lovastatin, meperidine, methylergonovine, midazolam, pimozide, piroxicam, propafenone,\r\n        propoxyphene, quinidine, simvastatin, terfenadine, and triazolam (these drugs have been\r\n        excluded for safety reasons).\r\n\r\n        Carbamazepine, dexamethasone, phenobarbital, primidone, rifampin, St Johns Wort, (these\r\n        drugs have been excluded because they have the potential to decrease plasma protease\r\n        inhibitor concentrations).\r\n\r\n          -  Treatment with other investigational drugs/therapies within 28 days prior to receiving\r\n             study medication (note: treatments available through a Treatment IND or other\r\n             expanded-access mechanism will be evaluated on a case-by-case basis in consultation\r\n             with the sponsor).\r\n\r\n          -  History of drug or other allergy which, in the opinion of the investigator,\r\n             contraindicates participation in the trial or known hypersensitivity to any study\r\n             medications (e.g. documented hypersensitivity to a nucleoside analogue).\r\n      ","sponsor":"ViiV Healthcare","sponsor_type":"Industry","conditions":"Infection, Human Immunodeficiency Virus","interventions":[{"intervention_type":"Drug","name":"Drug: GW433908","description":"Fosamprenavir suspension bid"},{"intervention_type":"Drug","name":"Drug: ritonavir","description":"Ritonavir solution bid"}],"outcomes":[{"outcome_type":"primary","measure":"Plasma Amprenavir (APV) AUC (0-tau[τ])","time_frame":"Week 48","description":"Plasma samples were assayed for APV concentrations using a validated assay. The GlaxoSmithKline (GSK) Department of Clinical Pharmacology Modeling and Simulation conducted pharmacokinetic (PK) analysis of the plasma APV concentration-time data using a model-independent approach. As a measure of total drug exposure, the area under the plasma-concentration-versus-time curve over the dosing interval at steady-state (AUC[0-τ]), where \"τ\" is the length of the dosing interval, was calculated by the linear up/log down trapezoidal method. hours, hr."},{"outcome_type":"primary","measure":"Plasma APV Cmax","time_frame":"Week 48","description":"The maximum concentration at steady state (Cmax) was measured."},{"outcome_type":"primary","measure":"Plasma APV Cτ","time_frame":"Week 48","description":"The plasma concentration at the end of the dosing interval at steady state (Cτ) was measured."},{"outcome_type":"primary","measure":"Plasma APV CL/F Following Dosing Expressed in mL/Min/kg","time_frame":"Week 48","description":"Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated using the formulation: APV Dose in mg/kg units divided by AUC(0-τ). For FPV, doses were expressed in APV molar equivalents (50 mg of FPV = 43.2 mg of APV). Normalizing CL/F for bodyweight allows for comparison of CL/F across populations."},{"outcome_type":"primary","measure":"Plasma APV CL/F Following Dosing Expressed in mL/Min","time_frame":"Week 48","description":"Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose/AUC(0-τ). For FPV, doses were expressed in APV molar equivalents (50 mg of FPV = 43.2 mg of APV)."},{"outcome_type":"primary","measure":"Plasma Unbound APV Cτ","time_frame":"Week 48","description":"Participants who are <2 years old may have reduced protein binding; therefore, plasma unbound APV concentrations were measured to determine dosing recommendations at acceptable dosing volumes. Unbound or \"free\" APV is the fraction of drug that is not bound to protein. Cτ is the plasma concentration at the end of the dosing interval at steady state."},{"outcome_type":"primary","measure":"Plasma Unbound APV Percent Protein Binding (%Cτ)","time_frame":"Week 48","description":"Participants who are <2 years old may have reduced protein binding; therefore, plasma unbound APV concentrations were measured to determine dosing recommendations at acceptable dosing volumes. APV %Cτ unbound is the percentage of the total APV Cτ that is unbound."},{"outcome_type":"primary","measure":"Median Change From Baseline in Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Weeks 4, 12, 24, 36, and 48","time_frame":"Baseline (Day 1) and Weeks 4, 12, 24, 36, and 48","description":"Blood samples of the participants were collected for the evaluation of ALT and AST. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in ALT and AST was calculated as the value at the indicated time point minus the value at Baseline."},{"outcome_type":"primary","measure":"Median Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Triglyceride (TG), Potassium, and Sodium at Weeks 4, 12, 24, 36, and 48","time_frame":"Baseline (Day 1) and Weeks 4, 12, 24, 36, and 48","description":"Blood samples of all participants were generally collected under non-fasting conditions (given the age of participants) for the evaluation of cholesterol, serum glucose, HDL cholesterol, LDL cholesterol, triglyceride, potassium, and sodium. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in cholesterol, serum glucose, HDL cholesterol, LDL cholesterol, triglyceride, potassium, and sodium was calculated as the value at the indicated time point minus the value at Baseline."},{"outcome_type":"primary","measure":"Median Change From Baseline in Serum Lipase at Weeks 4, 12, 24, and 48","time_frame":"Baseline (Day 1) and Weeks 4, 12, 24, and 48","description":"Blood samples of all participants were collected for the evaluation of serum lipase. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in serum lipase was calculated as the value at the indicated time point minus the value at Baseline."},{"outcome_type":"primary","measure":"Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Laboratory Abnormalities","time_frame":"Baseline (Day 1) until Week 48","description":"TE toxicities were presented for each laboratory parameter. A toxicity was considered TE if it was greater than the Baseline grade, and if it was observed on/after the date of the first dose of study drug (SD), and on/before the date of the last dose of SD. Neutropenia is a decrease (d) in the number of Ns, d/increase (I) in glucose is hypo (Hp)/hyper (Hy)glycemia, in potassium is Hp/Hykalemia, and in sodium is Hp/Hynatremia. Per the Division of AIDS Table for Grading the Severity of Adult and Pediatric AEs, Grade 3=severe; Grade 4=potentially life-threatening."},{"outcome_type":"primary","measure":"Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Adverse Events (AE)","time_frame":"Baseline (Day 1) until Week 48","description":"An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE is considered TE if it has an onset date on or after the date of the first dose of study drug, and on or before the date of the final dose of study drug. As per the Division of AIDS Table for Grading the Severity of Adult and Pediatric AEs, Grade 3=severe; Grade 4=potentially life-threatening."},{"outcome_type":"primary","measure":"Number of Participants Who Permanently Discontinued the Treatment Due to an AE","time_frame":"Baseline (Day 1) until Week 48","description":"An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product."},{"outcome_type":"secondary","measure":"Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 4, 12, 24, 36, and 48 (MSD=F)","time_frame":"Baseline and Weeks 4, 12, 24, 36, and 48","description":"Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the Missing, Switch, or Discontinuation=Failure (MSD=F) analysis, participants who had missing data at or had discontinued the study prior to a certain time point or had changed their background antiretroviral regimen are classified as non-responders."},{"outcome_type":"secondary","measure":"Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 4, 12, 24, 36, and 48 (Observed Analysis)","time_frame":"Baseline and Weeks 4, 12, 24, 36, and 48","description":"Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA copies."},{"outcome_type":"secondary","measure":"Median Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 4, 12, 24, 36, and 48 (Observed Analysis)","time_frame":"Baseline and Weeks 4, 12, 24, 36, and 48","description":"Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA copies. Change from Baseline in plasma HIV-1 RNA was calculated as the value at the indicated time point minus the value at Baseline."},{"outcome_type":"secondary","measure":"Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 4, 12, 24, 36, and 48 (MSD=F Analysis)","time_frame":"Baseline and Weeks 4, 12, 24, 36, and 48","description":"Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA copies. In the MSD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point or had changed their background antiretroviral regimen are classified as non-responders."},{"outcome_type":"secondary","measure":"Median Percent Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 4, 12, 24, 36, and 48","time_frame":"Baseline and Weeks 4, 12, 24, 36, and 48","description":"Blood samples of participants were collected for the measurement of the percentage of total lymphocytes that are CD4+ cells. Observed analysis was used for the summary of proportion endpoints using viral load data. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. A CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV."},{"outcome_type":"secondary","measure":"Median Percent Change From Baseline in CD4+ Cell Count at Weeks 4, 12, 24, 36, and 48","time_frame":"Baseline and Weeks 4, 12, 24, 36, and 48","description":"Blood samples of participants were collected for the measurement of the percentage of total lymphocytes that are CD4+ cells. Observed analysis was used for the summary of proportion endpoints using viral load data. Change from Baseline in percentage was calculated as the value at indicated time points minus the value at Baseline."},{"outcome_type":"secondary","measure":"Number of Participants With the Indicated Virological Outcome at Week 48","time_frame":"Week 48","description":"Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations. PI-exp = PI-experienced. Virologic success was defined as plasma HIV-1 RNA <400 copies/mL. Virologic failure: (1) HIV-1 RNA >=400 copies/mL, (2) change of background antiretroviral treatment (ART), (3) discontinued study due to lack of efficacy, (4) discontinued study with last HIV-1 >=400 copies/mL. No virologic data at Week 48 window: (a) discontinued study due to an adverse event or death, (b) discontinued study due to other reasons (withdrew consent, loss to follow-up, moved, etc.)."},{"outcome_type":"secondary","measure":"Plasma Ritonavir (RTV) AUC (0-τ)","time_frame":"Week 48","description":"Plasma samples were assayed for RTV concentrations using a validated assay. The GSK Department of Clinical Pharmacology Modeling and Simulation conducted PK analysis of the plasma RTV concentration-time data using a model-independent approach. As a measure of total drug exposure, the area under the plasma-concentration-versus-time curve over the dosing interval at steady-state (AUC[0-τ]), where τ is the length of the dosing interval, was calculated by the linear up/log down trapezoidal method."},{"outcome_type":"secondary","measure":"Plasma RTV Cmax","time_frame":"Week 48","description":"The maximum concentration at steady state (Cmax) was measured."},{"outcome_type":"secondary","measure":"Plasma RTV Cτ","time_frame":"Week 48","description":"The plasma concentration at the end of the dosing interval at steady state (Cτ) was measured."},{"outcome_type":"secondary","measure":"Plasma RTV CL/F Expressed in mL/Min/kg","time_frame":"Week 48","description":"Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose in mg/kg units divided by AUC(0-τ). Normalizing CL/F for bodyweight allows for comparison of CL/F across populations."},{"outcome_type":"secondary","measure":"Plasma RTV CL/F Expressed in mL/Min","time_frame":"Week 48","description":"Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose in mg/kg units divided by AUC(0-τ)."},{"outcome_type":"secondary","measure":"Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease","time_frame":"Baseline through Week 48","description":"A blood sample was drawn for par. failing to respond to therapy, and the mutations present in the virus were identified. For each par., the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDS Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. Par. are grouped by study arm and prior therapy experience."},{"outcome_type":"secondary","measure":"Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS)","time_frame":"Baseline through Week 48","description":"A blood sample was drawn for par. failing to respond to therapy, and changes in DS for HIV isolated from the par. for each drug used in the study were assessed. The changes in DS detected by phenotypic assay in virus from the sample collected at the time of failure was compared with DS in the virus from the blood sample at baseline. Par. are grouped by study arm and prior therapy experience. DS is the state of HIV being susceptible to the antiretroviral agent (the virus can be inhibited by the drug). Reduced DS (i.e., HIV is resistant to the antiretroviral agent) can lead to treatment failure."},{"outcome_type":"secondary","measure":"Number of Participants Reporting Perfect Adherence Over the 3 Days and Last Weekend Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by the Study Coordinator Using the Adherence Questionnaire","time_frame":"Weeks 2, 12, 24, and 48","description":"A separate questionnaire were administered for FPV and RTV. Items 1-4 of the Adherence Questionnaire measured a participant's adherence with FPV or RTV during the last 3 days and the weekend prior to the indicated study visits. Question 5 queried about the number of doses of FPV or RTV missed since the participant's last study visit. Perfect adherence was defined as not missing any doses of FPV or RTV since the last study visit."},{"outcome_type":"secondary","measure":"Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4","time_frame":"Weeks 2, 24, and 48/premature study discontinuation","description":"P/G perceptions of FPV/RTV BID were assessed using a P/G Perception of Study Medication questionnaire administered during Weeks 2, 24, and 48/premature study discontinuation. Questions 1 to 4 ask directly about the P/G's assessment of 1=color, 2=texture/consistency, 3=odor, and 4=general satisfaction. Questions 5 to 10 ask about the P/G's perception of the child's assessment of the oral suspension. Data are reported as the number of participants with the indicated response by question, response category (1-3=dislike, 4=neutral, 5-7=like), and timing of visit."},{"outcome_type":"secondary","measure":"Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10","time_frame":"Weeks (W) 2, 24, and 48/premature study discontinuation","description":"Parent/guardian perceptions of FPV/RTV BID was assessed using a Parent/Guardian Perception of Study Medication questionnaire. Questions 1 to 4 ask directly about the parent/guardian's assessment of the color, texture/consistency, odor, and general satisfaction. Questions 5 to 10 ask about the parent/guardian's perception of the child's assessment of the oral suspension (Items: 5=reaction to new medicine [med.]; 6=taste; 7=acceptance; 8=swallowing; 9=willingness compared to other med.; 10=overall liking. Data for items 6/10 are reported in response categories: 1-3=dislike; 4=neutral; 5-7=like."},{"outcome_type":"secondary","measure":"Correlation Between Steady-state Plasma APV PK Parameters to Changes in Plasma HIV-1 RNA Concentrations, CD4+ Percentages, and/or the Occurrence of Adverse Events","time_frame":"Week 48","description":"No formal analysis has been performed or is planned to correlate plasma APV PK with efficacy and safety outcomes."},{"outcome_type":"secondary","measure":"Plasma FPV AUC (0-τ)","time_frame":"Week 48","description":"The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated."},{"outcome_type":"secondary","measure":"Plasma FPV Cmax and Cτ","time_frame":"Week 48","description":"The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated."},{"outcome_type":"secondary","measure":"Plasma FPV CL/F Expressed in mL/Min/kg","time_frame":"Week 48","description":"The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated."},{"outcome_type":"secondary","measure":"Plasma FPV CL/F Expressed in mL/Min","time_frame":"Week 48","description":"The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated."}]}
{"nct_id":"NCT00247715","start_date":"2003-10-31","phase":"N/A","enrollment":664,"brief_title":"Comparison of a \"Step-Up\" Versus a \"Step-Down\" Treatment Strategy for Patients With New Onset Dyspepsia in General Practice (The DIAMOND-Study)","official_title":"Comparison of an Antacid/H2-Receptor Antagonist/Proton Pump Inhibitor Versus a Proton Pump Inhibitor/H2-Receptor Antagonist/Antacid Treatment Strategy for Patients With New Onset Dyspepsia in General Practice (The DIAMOND-Study)","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-01-31","last_update":"2007-08-29","description":"The purpose of this study was to determine which treatment strategy, the step-up or the step-down treatment strategy, is the most cost-effective treatment for patients with new onset dyspepsia in primary care.","other_id":"945-03-052","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Presence of a new episode of dyspepsia, defined as episodic or persistent symptoms\r\n             including abdominal pain or discomfort and which are, in the opinion of the general\r\n             practitioner, referable to the upper gastrointestinal tract.\r\n\r\n          -  Over 18 years of age\r\n\r\n          -  Informed consent (written) given.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Use of prescribed acid suppressive medication during 3 months before consult\r\n\r\n          -  Investigated by upper gastrointestinal endoscopy one year before inclusion\r\n\r\n          -  Malignancy\r\n\r\n          -  Contraindication to the study medication\r\n\r\n          -  Pregnancy\r\n\r\n          -  Alarming symptoms like weight loss, bleeding, and disturbed food passage\r\n\r\n          -  Patients with insufficient comprehension of the Dutch language\r\n      ","sponsor":"Radboud University","sponsor_type":"Other","conditions":"Dyspepsia|Gastrointestinal Diseases","interventions":[{"intervention_type":"Drug","name":"Drug: algeldrate/magnesium oxide"},{"intervention_type":"Drug","name":"Drug: ranitidine"},{"intervention_type":"Drug","name":"Drug: pantoprazole"}],"outcomes":[{"outcome_type":"primary","measure":"Cost-efficacy","time_frame":"6 months"},{"outcome_type":"secondary","measure":"Severity of gastrointestinal symptoms","time_frame":"2 weeks, after each treatment steps, and 6 months"},{"outcome_type":"secondary","measure":"Quality of life","time_frame":"2 weeks, after each treatment step, and 6 months"},{"outcome_type":"secondary","measure":"Genetic and psychosocial determinants","time_frame":"baseline and 6 months"},{"outcome_type":"secondary","measure":"Patient compliance after treatment","time_frame":"0 to 6 months"}]}
{"nct_id":"NCT00693823","start_date":"2003-09-30","phase":"N/A","enrollment":86,"brief_title":"Comparison of Prosthetic Femoropopliteal Bypass Versus Viabahn Endoprosthesis for Treatment of Symptomatic Femoral Artery Occlusive Disease","official_title":"A Prospective Randomized Comparison of Prosthetic Femoropopliteal Bypass Versus Viabahn Endoprosthesis for Treatment of Symptomatic Superficial Femoral Artery Occlusion","primary_completion_date":"2007-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-01-31","last_update":"2008-06-09","description":"This study is a comparison of two different ways to treat blockage in the artery of the thigh. The first is an older way with incisions in the groin and just above the knee. A plastic tube is then inserted to make a bypass from the groin to the knee. The second treatment offered is through a needle hole in the groin. A thin plastic tube covering a metal stent is inserted into the artery and released to bypass the blockage from inside the artery. No incisions are needed. Patients are enrolled and then selected for one treatment method or another by chance. The patients will be followed for two years to see how the two different treatment methods work compared to each other.","other_id":"003-179, Viabahn #1","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:Patients that had atherosclerotic stenotic or occlusive lesions of the\r\n        superficial femoral artery with no significant aorto-iliac disease. The infra-popliteal\r\n        segment had to be patent with at least single vessel run-off to the ankle. Patients had to\r\n        be acceptable surgical candidates in the event they were randomized to the surgical arm.\r\n\r\n        -\r\n\r\n        Exclusion Criteria:Non-operative candidate,Contraindication to IV contrast use, Planned\r\n        surgery with venous conduit, previously stented segment of the superficial femoral artery,\r\n        poorly compliant patient.\r\n\r\n        -\r\n      ","sponsor":"Texas Vascular Associates","sponsor_type":"Other","conditions":"Atherosclerosis|Lower Extremity Ischemia|Claudication|Rest Pain","interventions":[{"intervention_type":"Procedure","name":"Procedure: Femoral-popliteal Bypass","description":"Surgical placement of a prosthetic graft in the thigh from the groin to the knee"},{"intervention_type":"Device","name":"Device: Angioplasty and stent placement with Viabahn covered stent-graft(W.L. Gore & Associates, Flagstff, Arizona) of superficial femoral artery","description":"Placement of an ePTFE covered stent graft within the superficial femoral artery in the thigh through a needle hole percutaneously"}],"outcomes":[{"outcome_type":"primary","measure":"Primary artery/graft patency","time_frame":"24 months"},{"outcome_type":"primary","measure":"Limb Salvage","time_frame":"24 months"},{"outcome_type":"primary","measure":"Improvement in symptoms of lower extremity Ischemia","time_frame":"24 Months"},{"outcome_type":"secondary","measure":"Secondary artery/graft patency","time_frame":"24 months"}]}
{"nct_id":"NCT00136344","start_date":"2003-09-30","phase":"N/A","enrollment":35000,"brief_title":"Study of Antibiotic Prophylaxis for Endophthalmitis Following Cataract Surgery","official_title":"Antibiotic Prophylaxis for Cataract Surgery Version 7e January 22 2003","study_type":"Interventional","rec_status":"Completed","completion_date":"2006-05-31","last_update":"2016-02-12","description":"Cataract is the most important cause of visual impairment and decreased mobility in the elderly. While surgery is usually successful, it is also responsible for permanent loss of vision in up to 0.1% of patients due to severe post-operative infection (endophthalmitis). Because of this risk, surgery is typically performed on one eye at a time leaving the patient with a monocular cataract causing considerable visual impairment with reduction in mobility and quality of life. A second operation is required which often takes place up to one year later. It is not known at present whether the post-operative complication of endophthalmitis can be prevented by perioperative use of antibiotics. This randomised study (masked and placebo-controlled for topical levofloxacin and unmasked for intracameral injection of cefuroxime) sets out to test in 4 groups, each of 8,750 cataract surgery patients, if either topical antibiotic (levofloxacin) perioperatively or an intraocular (intracameral) injection of antibiotic (cefuroxime) at the end of phacoemulsification cataract surgery or the combination provides effective prophylaxis of post-operative infection (endophthalmitis) compared to controls in whom perioperative antibiotics are not used. The result will provide a scientific basis for prophylaxis of infection (endophthalmitis) following cataract surgery in Europe as well as an accurate figure for the incidence of endophthalmitis following phacoemulsification cataract surgery in Europe for the first time.","other_id":"MREC Ref. no. 02/5/46","allocation":"Randomized","intervention_model":"Factorial Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  All patients, including diabetics, undergoing routine cataract surgery in each unit\r\n             taking part in the study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients who do not wish to take part in the trial\r\n\r\n          -  Patients allergic to penicillins and cephalosporins.\r\n\r\n          -  Long-term nursing home patients\r\n\r\n          -  Patients with only one eye\r\n\r\n          -  Pregnancy.\r\n\r\n          -  Children less than 18 years old.\r\n\r\n          -  All severely 'at-risk' groups for infection including:\r\n\r\n               -  Severe atopic keratoconjunctivitis;\r\n\r\n               -  Severe active blepharitis;\r\n\r\n               -  Ocular cicatricial pemphigoid.\r\n\r\n          -  Patients with complicated cataracts such as traumatic or subluxated\r\n\r\n          -  Patients having combined operations with cataract surgery such as trabeculectomy or a\r\n             corneal graft.\r\n\r\n          -  Patients known to be allergic to povidone iodine (very rare) or any other known\r\n             hypersensitivity to any components of the study medications.\r\n\r\n          -  Patients who are incapacitated mentally and incapable of giving consent.\r\n\r\n          -  Patients with severe thyroid disease\r\n\r\n          -  Open infection anywhere, infection of lacrimal drainage channels or infection around\r\n             the eye\r\n      ","sponsor":"City, University of London","sponsor_type":"Other","conditions":"Endophthalmitis","interventions":[{"intervention_type":"Drug","name":"Drug: Cefuroxime"},{"intervention_type":"Drug","name":"Drug: Levofloxacin"}],"outcomes":[{"outcome_type":"primary","measure":"Prevention of post-operative endophthalmitis following phacoemulsification cataract surgery in Europe due to use of perioperative antibiotics"},{"outcome_type":"primary","measure":"Incidence of endophthalmitis in Europe following phacoemulsification cataract surgery"},{"outcome_type":"secondary","measure":"Effect of risk factors on the presentation of endophthalmitis in Europe following phacoemulsification cataract surgery"}]}
{"nct_id":"NCT00504660","start_date":"2003-09-30","phase":"Phase 2","enrollment":75,"brief_title":"6-TG, Capecitabine and Celecoxib Plus TMZ or CCNU for Anaplastic Glioma Patients","official_title":"Combination of 6-Thioguanine, Capecitabine, Celecoxib and Temozolomide or CCNU for Recurrent Anaplastic Glioma and Glioblastoma Multiforme","primary_completion_date":"2010-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-08-31","last_update":"2012-01-11","description":"The goal of this clinical research study is to learn if the combination of 6-Thioguanine, Xeloda (capecitabine), and Celebrex (celecoxib) with Temodar (temozolomide) or Lomustine (CCNU) is effective in the treatment of recurrent or progressive anaplastic glioma or glioblastoma multiforme in patients who have failed previous treatments. The safety of these combination treatment will also be studied. Objectives: 1.1 To determine the efficacy, as measured by 12 month progression-free survival, of TEMOZOLOMIDE or CCNU with 6-THIOGUANINE followed by CAPECITABINE and CELECOXIB in the treatment of patients with recurrent and/or progressive anaplastic gliomas or glioblastoma multiforme. 1.2 To determine the long-term toxicity of TEMOZOLOMIDE or CCNU with 6-THIOGUANINE followed by CAPECITABINE and CELECOXIB in recurrent anaplastic glioma or glioblastoma multiforme patients treated in this manner. 1.3 To determine the clinical relevance of genetic subtyping tumors as a predictor of response to this chemotherapy and long term survival","other_id":"2003-0600","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":12,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. All patients must sign an informed consent indicating that they are aware of the\r\n             investigational nature of this study in keeping with the policies of this hospital.\r\n\r\n          2. Patients with histologically proven supratentorial anaplastic oligodendrogliomas,\r\n             anaplastic mixed oligoastrocytomas anaplastic astrocytomas or glioblastoma multiforme.\r\n\r\n          3. Patients must have unequivocal evidence for tumor recurrence or progression by MRI\r\n             scan performed within 14 days prior to enrollment or documented recurrence by tumor\r\n             resection. Patients must have received radiation therapy previously.\r\n\r\n          4. Patients having undergone recent resection of recurrent or progressive tumor will be\r\n             eligible as long as all the following conditions are met: a) Patients have recovered\r\n             from the effects of surgery; b) Extent of residual disease (if present) has been\r\n             documented by MRI performed no later than 72 hours after surgery or, if not possible,\r\n             at least 4 weeks post-operative. Radiographic evidence of residual disease is not\r\n             mandated for enrollment.\r\n\r\n          5. The baseline on-study MRI is performed within 14 days of enrollment and on a steroid\r\n             dosage that has been stable. If the steroid dose is increased between the date of\r\n             imaging and the initiation of chemotherapy, a new baseline MRI is required on stable\r\n             steroids for 7 days.\r\n\r\n          6. Patients must be equal to or greater than 12 years old.\r\n\r\n          7. Patients must have a Karnofsky performance status of equal to or greater than 60\r\n             (Karnofsky Performance Scale; Appendix D).\r\n\r\n          8. Patients must have recovered from the toxic effects of prior therapy: 4 weeks from\r\n             prior cytotoxic therapy and/or at least two weeks from vincristine, 6 weeks from\r\n             nitrosoureas, 3 weeks from procarbazine administration, and 1 week for non-cytotoxic\r\n             agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc.\r\n             (radiosensitizer does not count). Any questions related to the definition of\r\n             non-cytotoxic agents should be directed to the Study Chair.\r\n\r\n          9. Patients must have adequate bone marrow function (ANC equal or greater than 1,500/mm3\r\n             and platelet count of equal or greater than 100,000/mm3), adequate liver function\r\n             (SGPT and alkaline phosphatase <2 times normal, bilirubin <1.5 mg%), and adequate\r\n             renal function (BUN and creatinine <1.5 times institutional normal) prior to starting\r\n             therapy.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients with a history of any other cancer (except non-melanoma skin cancer or\r\n             carcinoma in-situ of the cervix), unless in complete remission and off of all therapy\r\n             for that disease for a minimum of 3 years (1 year for localized prostate carcinoma\r\n             treated by prostatectomy or irradiation) are ineligible.\r\n\r\n          2. Patients of childbearing potential must not be pregnant or become pregnant.\r\n\r\n          3. Patients must not have: a) active infection; b) disease that will obscure toxicity or\r\n             dangerously alter drug metabolism; c) serious intercurrent medical illness; d) acute\r\n             or chronic pulmonary disease, pulmonary embolus, hypertension, diabetes, metabolic\r\n             syndrome, stroke, heart disease,myocardial infarction, angina, coronary angioplasty,\r\n             congestive heart failure, or coronary bypass surgery; e) allergies to sulfa drugs; f)\r\n             severe psychiatric illness; g) uncontrolled hypertension (i.e. ->135/>85 mm Hg) on\r\n             three repeated measurements during the 6 weeks prior to enrollment on the study\r\n\r\n          4. Patients must not have (continued): h) family history of premature coronary disease\r\n             (i.e. - onset < 55 years of age); i) uncontrolled hypercholesteremia [low-density\r\n             lipoprotein cholesterol (LDL-C >130]. Hypercholesteremia must be controlled for at\r\n             least 3 months prior to enrollment on study; j) history of systemic lupus\r\n             erythematous, family history of protein S or C deficiencies, prior heparin-induced\r\n             thrombocytopenia, Factor V Leiden deficiencies or high homocysteine levels; k) any\r\n             indications for ASA deficiency\r\n\r\n          5. Patients must not have had prior treatment with Capecitabine, 5-FU or a combination of\r\n             Temozolomide with CCNU (Lomustine) or BCNU (Carmustine). Patients who received only\r\n             Temozolomide during radiation therapy and did not receive adjuvant chemotherapy with\r\n             Temozolomide and/or those who received Gliadel (BCNU) wafers at surgery without\r\n             adjuvant chemotherapy with BCNU or CCNU are eligible if 6 months has passed since the\r\n             treatment(s).\r\n      ","sponsor":"M.D. Anderson Cancer Center","sponsor_type":"Other","conditions":"Anaplastic Glioma of Brain|Glioblastoma Multiforme|Brain Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Capecitabine","description":"Arms 1,3 = 825 mg/m^2 By Mouth (PO) Every 12 Hours on Day 14-27; Arms 2,3 = 825 mg/m^2 PO Every 12 Hours on Day 11-24."},{"intervention_type":"Drug","name":"Drug: Celecoxib (Celebrex)","description":"Arms 1,3 = 400 mg PO Every 12 Hours On Day 14-27; Arms 2,3 = 400 mg PO Every 12 Hours On Day 11-24."},{"intervention_type":"Drug","name":"Drug: Temozolomide","description":"Arms 1,3 = 150 mg/m^2 PO Daily On Day 4-8."},{"intervention_type":"Drug","name":"Drug: Lomustine","description":"Arms 2,3 = 100 mg/m^2 PO on Day 4."},{"intervention_type":"Drug","name":"Drug: 6-Thioguanine","description":"Arms 1,2,3 = 80 mg/m^2 PO Every 6 Hours on Day 1-3."}],"outcomes":[{"outcome_type":"primary","measure":"12 Month-progression-free Survival for Participants With Anaplastic Tumors","time_frame":"12 months","description":"Progression-free Survival (PFS) at 12 months measured as percentage of participants that are alive and progression-free at 12 months (anaplastic tumors). A combination of neurological examination and MRI brain scan used to define overall response or progression."},{"outcome_type":"primary","measure":"6 Month Progression-free Survival for Participants With Glioblastoma","time_frame":"6 months","description":"Progression-free Survival (PFS) at 6 months measured as percentage of participants that are alive and progression-free at 6 months (glioblastoma multiforme). A combination of neurological examination and MRI brain scan used to define overall response or progression."}]}
{"nct_id":"NCT00177892","start_date":"2003-09-30","phase":"N/A","enrollment":76,"brief_title":"Obstructive Sleep Apnea (OSA) and Metabolic Syndrome: Role of Oxidative Stress","official_title":"OSA and Metabolic Syndrome: Role of Oxidative Stress","primary_completion_date":"2008-08-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2008-08-31","last_update":"2008-03-03","description":"The purpose of this study is to define the mechanism(s) through which Obstructive Sleep Apnea/Hypopnea (OSAH) promotes abnormal metabolic processes which characterize the metabolic syndrome. The investigators hypothesize that the sleep fragmentation and intermittent sleep hypoxia which occur in OSAH patients promote oxidative stress and inflammation which in turn lead to insulin resistance, dyslipidemia, abnormal vascular reactivity and other processes which are consistent with the metabolic syndrome.","other_id":"AG0089","allocation":"Non-Randomized","intervention_model":"Crossover Assignment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Nonsmoker for at least 6 months\r\n\r\n          -  No history of movement disorder during sleep, or circadian rhythm disorder\r\n\r\n          -  No excessive daytime sleepiness\r\n\r\n          -  No history of chronic insomnia, mood or affective disorders or other psychiatric\r\n             disorders\r\n\r\n          -  Participants maintain a regular sleep-wake pattern with an estimated sleep time\r\n             between 6.5 and 10 hours per night\r\n\r\n          -  Ability and willingness to avoid meat with its juice (gravy), cured or smoked foods\r\n             and green leafy vegetables, fruit and fruit juices, food products or vitamin\r\n             supplements containing vitamin C and E supplements for at least 1 day prior to and\r\n             during the study periods\r\n\r\n          -  Consumption of less than 1 alcoholic beverage per day\r\n\r\n          -  Ability to understand the study and sign the informed consent\r\n\r\n          -  Not currently pregnant\r\n\r\n          -  Live within 45 miles of the study site\r\n\r\n          -  No uncontrolled hypertension (blood pressure greater than 150/100)\r\n\r\n          -  Willingness to avoid caffeinated beverages and food during the study protocol period\r\n\r\n        Participants With Sleep Apnea:\r\n\r\n          -  Diagnosis of severe Obstructive Sleep Apnea and Hypopnea (OSAH) (RDI greater than 25)\r\n             and initiation of positive airway pressure therapy more than 1 month before enrollment\r\n\r\n          -  Must have had an adequate clinical titration of positive airway pressure therapy\r\n\r\n          -  On positive airway pressure for at least 1 month with adherence of more than 5 hours\r\n             of use per day with no history of snoring, no excessive daytime sleepiness and no\r\n             reported observed apnea episodes on positive airway pressure\r\n\r\n          -  Willing to sleep with and without positive airway pressure therapy as required by the\r\n             study protocol\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History or physical examination evidence of active coronary artery disease, heart\r\n             failure, cardiomyopathy, syncope, potentially life-threatening arrhythmia, stroke,\r\n             transient ischemic attack, neurologic impairment, renal, hepatic or thyroid disease\r\n             (unless on stable thyroid replacement medication); history of diabetes mellitus;\r\n             history of cancer within the past 10 years (other than basal cell carcinoma), venous\r\n             thrombosis, or collagen-vascular disease or other condition that the investigators\r\n             believe may be exacerbated by participation in the stud\r\n\r\n          -  History of awakening with angina pectoris\r\n\r\n          -  Currently taking medication for mood or affective disorders or that affect heme\r\n             metabolism, autonomic nervous system or sleep architecture, or prescribed nitrates or\r\n             corticosteroids\r\n\r\n          -  Physician-diagnosed Alzheimer's or non-Alzheimer's dementia\r\n\r\n          -  Previous surgery for sleep apnea\r\n\r\n          -  Hematocrit less than 32\r\n\r\n          -  Use of a hearing aid in one or both ears\r\n\r\n          -  History of a bleeding disorder, abnormal bleeding, or known adverse reaction to\r\n             heparin\r\n\r\n          -  Inability to obtain venous blood or a low likelihood of obtaining venous access as\r\n             required in this protocol\r\n\r\n          -  History of migraine of a nature, frequency, and severity that, in the investigators'\r\n             judgement, may be precipitated by participation in the protocol\r\n\r\n          -  Presence of a potentially life-threatening dysrhythmia on the clinical diagnostic PSG\r\n\r\n          -  History of motor vehicle accident due to falling asleep; not currently employed as a\r\n             driver in the transportation industry or an airplane pilot\r\n\r\n          -  Lipid-lowering agents for participants without a history of sleep apnea\r\n\r\n          -  Individuals on positive airway pressure therapy for sleep apnea must not have lost\r\n             more than 10 pounds of weight since starting this treatment\r\n      ","sponsor":"National Institute on Aging (NIA)","sponsor_type":"NIH","conditions":"Obstructive Sleep Apnea|Metabolic Syndrome X","interventions":[{"intervention_type":"Procedure","name":"Procedure: sleep disruption","description":"experimentally-induced Sleep Fragmentation"},{"intervention_type":"Procedure","name":"Procedure: sleep with and without positive pressure","description":"OSAH patients with and without chronic positive airway pressure therapy"}],"outcomes":[{"outcome_type":"primary","measure":"circulating and exhaled biomarkers of oxidative stress and pro-inflammatory cytokines, insulin resistance, lipid profile, plasma cortisol, and heart period variability (a reflection of sympathovagal tone)","time_frame":"before and after 2 consecutive nights"}]}
{"nct_id":"NCT01789229","start_date":"2003-09-30","enrollment":10000,"brief_title":"Establishment of a Tumor Bank for Tissue Samples","official_title":"Establishment of a Tissue Sample Bank in the Field of Gynaecological Oncology","primary_completion_date":"2025-01-31","study_type":"Observational","rec_status":"Recruiting","completion_date":"2025-01-31","last_update":"2021-08-31","description":"Establishment of a tumor bank, consisting of tissue samples of tumor patients (benign and malign tumors) and healthy people as controls. The tissue samples will be collected systematically together with the corresponding clinical data. The biological samples, the clinical date together with prospective experimental date constitute the entity of the tissue tumor bank. This tumor bank for tissue samples, together with our tumorbank for blood samples (NCT01763125) combined constitute the entity \"Tumorbank\".","other_id":"EK 260/2003","observational_model":"Case-Control","time_perspective":"Other","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Male and female patients/people. Minimum age 18 years Characteristics: Recruited at the\r\n        Medical University Vienna or at one of the facilities cooperating with the Vienna Med.\r\n        University","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male/Female\r\n\r\n          -  Age 18 to 90 years max.\r\n\r\n          -  Just one current known malignant disease or just one current inflammatory disease\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Inflammatory disease and malignant disease\r\n\r\n          -  multiple malignancies\r\n\r\n          -  multiple diseases\r\n\r\n          -  underage\r\n      ","sponsor":"Medical University of Vienna","sponsor_type":"Other","conditions":"Ovarian Neoplasms|Breast Neoplasms|Colorectal Neoplasms|Neoplasms of the Female Genitalia|Lung Neoplasms|Endocrine Gland Neoplasms","interventions":[{"intervention_type":"Other","name":"Other: Tumor tissue collection","description":"Tissue sample is collected during therapeutic intervention by a medical doctor/surgeon.\r\nFrozen tissue sections are first transferred to Dept.of Pathology. Pathologist samples required tissue to obtain enough evidence for analysis/diagnosis.\r\nRest tumor material with or without malignant cells is tranferred to the lab for Molecular Oncology of Prof.Zeillinger."},{"intervention_type":"Other","name":"Other: Sampling of ascites and pleural effusion","description":"Samples of malignant ascites and/or malignant pleural effusion is only collected during therapeutic intervention from patients at inpatient care."},{"intervention_type":"Other","name":"Other: Collecting urine samples","description":"Patient is asked to give a urine sample. Urine is collected in urine beaker."},{"intervention_type":"Other","name":"Other: Collecting saliva sample","description":"Saliva sample is collected by spatula from the mouth cavity of the patient."},{"intervention_type":"Other","name":"Other: Collecting sputum","description":"Patient is asked to produce sputum into a 50ml lab tube."},{"intervention_type":"Other","name":"Other: Collecting stool samples","description":"Stool samples are collected prior to bowel preparation for colonoscopy. Device for sampling is provided to the patient."},{"intervention_type":"Other","name":"Other: Lavage/Irrigation","description":"Irrigation liquid is collected during routine therapeutic or diagnostic procedure, e.g. lavage of the uterine cavity and fallopian tubes of women scheduled for surgery."}],"outcomes":[{"outcome_type":"primary","measure":"Establishment of blood/tissue bank consisting of oncological samples from cancer patients and benign and healthy controls.","time_frame":"14 years"}]}
{"nct_id":"NCT00703651","start_date":"2003-09-30","phase":"Phase 2","enrollment":1150,"brief_title":"Study of Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route Versus Vaxigrip in Adults","official_title":"Immunogenicity of Two Dosages of Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route in Comparison With Intramuscular Vaccination With Vaxigrip in Adults","primary_completion_date":"2006-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2006-07-31","last_update":"2014-01-13","description":"This is a follow-up of a previous dose-ranging study aimed at investigating 2 doses of the trivalent inactivated split virion influenza vaccine when administered by intradermal route with that of the current pharmaceutical presentation administered by intramuscular route. Primary Objective: To assess the immunogenicity of two pharmaceutical presentations of the trivalent inactivated split virion influenza vaccine 21 days after a single injection in subjects aged 18 to 57 years. Secondary Objective: To evaluate the safety profile during the 21-day period following each vaccination in each study group","other_id":"GID02","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":57,"population":"","criteria":"\n        Inclusion Criteria :\r\n\r\n          -  Subject aged between 18 and 57 years (i.e., less than 60 at the last vaccination)\r\n\r\n          -  For woman of child-bearing potential, negative urine pregnancy test at V#01\r\n\r\n          -  Use of effective contraception prior to and during the trial\r\n\r\n          -  Subject available during the trial period\r\n\r\n          -  Subject able to read and understand the informed consent form\r\n\r\n          -  Informed consent form signed and dated by the subject prior to any protocol-required\r\n             intervention (and Visit 05 and Visit 07, respectively).\r\n\r\n        Exclusion Criteria :\r\n\r\n          -  Self-reported allergy to egg proteins, chick proteins, or any of the constituents of\r\n             the vaccine, in particular, neomycin, formaldehyde, and octoxinol 9\r\n\r\n          -  Acute febrile disease within the 72 hours preceding V#01, or axillary temperature\r\n             >37.5C the day of inclusion, prior to vaccination (>37.0C Czech Republic)\r\n\r\n          -  Subject with an aggravation of existing chronic illness (heart disease, respiratory\r\n             disease, etc.)\r\n\r\n          -  Vaccination against influenza within the 6 months preceding V#01\r\n\r\n          -  Any vaccination within the 28 days preceding V#01 or scheduled between V#01 and V#02\r\n\r\n          -  Breast-feeding\r\n\r\n          -  Immunosuppressive therapy including long term systemic corticotherapy (20 mg/day of\r\n             prednisolone or equivalent for >2 weeks) or cancer therapy within the month preceding\r\n             V#01 or ongoing\r\n\r\n          -  Immunoglobulin injection within the 3 months preceding V#01\r\n\r\n          -  Subject taking part or planned to take part in another clinical trial (3 months before\r\n             and through the trial duration)\r\n\r\n          -  Subject having received extracted pituitary hormones\r\n\r\n          -  Subjects who participated in the GID01 study (Lithuanian centers)\r\n      ","sponsor":"Sanofi Pasteur, a Sanofi Company","sponsor_type":"Industry","conditions":"Influenza|Orthomyxoviridae Infection|Myxovirus Infection","interventions":[{"intervention_type":"Biological","name":"Biological: Inactivated, split-virion influenza vaccine","description":"0.1 mL, ID. 1 injection/year for 3 years"},{"intervention_type":"Biological","name":"Biological: Inactivated, split-virion influenza vaccine","description":"0.1 mL, ID. 1 injection/year for 3 years."},{"intervention_type":"Biological","name":"Biological: Inactivated, split-virion influenza vaccine","description":"0.5 mL, IM. 1 injection/year for 3 years"}],"outcomes":[{"outcome_type":"primary","measure":"To provide information concerning the immunogenicity of Inactivated, Split-Virion Influenza Vaccine.","time_frame":"21days post-vaccination"},{"outcome_type":"primary","measure":"To provide information concerning the safety of Inactivated, Split-Virion Influenza Vaccine","time_frame":"21 days post-vaccination and entire study duration"}]}
{"nct_id":"NCT00100776","start_date":"2003-09-30","phase":"Phase 4","enrollment":600,"brief_title":"Efficacy of High Dose Olanzapine for the Treatment of Schizophrenia and Schizoaffective Disorder","official_title":"Efficacy of High Dose Olanzapine in a Controlled Fixed Dose-Response Trial for the Treatment of Schizophrenia and Schizoaffective Disorder","study_type":"Interventional","rec_status":"Completed","completion_date":"2005-11-30","last_update":"2007-01-26","description":"The purposes of this study are to assess the efficacy, safety, and side effects among doses approved by the Food and Drug Administration and higher (not FDA approved) doses of olanzapine in patients with schizophrenia or schizoaffective disorder.","other_id":"8333","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  You must be 18 to 60 years old\r\n\r\n          -  You must have been diagnosed with schizophrenia or schizoaffective disorder\r\n\r\n          -  You must be able to visit the doctor's office 8 times over a 9 week period\r\n\r\n          -  You must agree to participate with all tests and examinations that are required for\r\n             this study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  You are a woman and are pregnant or breastfeeding\r\n\r\n          -  You presently have an acute or unstable medical illness\r\n\r\n          -  You have a history of an allergic reaction to olanzapine\r\n\r\n          -  You are taking medications that are not permitted in this study. Your physician will\r\n             discuss these with you\r\n\r\n          -  You have taken part in another clinical research trial within the last 30 days or you\r\n             have received treatment with a drug in the last 30 days that has not received\r\n             regulatory approval.\r\n      ","sponsor":"Eli Lilly and Company","sponsor_type":"Industry","conditions":"Schizophrenia|Schizoaffective Disorder","interventions":[{"intervention_type":"Drug","name":"Drug: Olanzapine"}],"outcomes":[{"outcome_type":"secondary","measure":"To assess the dose response efficacy of olanzapine in improving psychopathology of schizophrenia as measured by a mean change from baseline on the PANSS subscores and Clinical Global Impression-Severity(CGI-S) Scale as well as by the absolute score"},{"outcome_type":"secondary","measure":"of CGI-I (Improvement) Scale"},{"outcome_type":"primary","measure":"The primary objective of this study is to assess the fixed dose response relationship for efficacy between standard and higher doses of olanzapine (10, 20, and 40 mg/day) in patients with schizophrenia or schizoaffective disorder."},{"outcome_type":"secondary","measure":"To assess the efficacy of olanzapine doses between treatment arms (e.g. 10 mg/day versus 40 mg/day ) in improving the psychopathology of schizophrenia as measured by mean changed from baseline on the PANSS total and subscores and Clinical Global"},{"outcome_type":"secondary","measure":"Impression-Severity (CGI-S) Scale as well as by absolute score of CGI-I (Improvement) Scale"},{"outcome_type":"secondary","measure":"To assess the efficacy of olanzapine doses as measured by efficacy scales in patients who have successfully completed the 2 week titration period"},{"outcome_type":"secondary","measure":"To assess the efficacy of olanzapine doses within the standard range of 10 and 20 mg/day versus high dose 40 mg/day in improving the psychopathology of schizophrenia as measured by mean change from baseline on the PANSS total"},{"outcome_type":"secondary","measure":"To assess the response rate of olanzapine doses in improving the psychopathology of schizophrenia. Clinical response is defined as an improvement (reduction) of =>20% from baseline in the PANSS total score"},{"outcome_type":"secondary","measure":"To compare the time to response among all olanzapine treatment arms. Clinical response is defined as an improvement (reduction) of =>20% from baseline in the PANSS total score. In addition, the cumulative frequency distribution of differential"},{"outcome_type":"secondary","measure":"rates of response reduction in PANSS total score will be assessed at 8 weeks"},{"outcome_type":"secondary","measure":"To compare the dose response efficacy between all olanzapine treatment arms in improving depressive symptoms as measured by a mean change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS)"},{"outcome_type":"secondary","measure":"To assess the efficacy between all olanzapine treatment arms in improving patients' overall level of functioning and health-related quality of life as measured by the Global assessment of Functioning (GAF) and the Heinrich Carpenter"},{"outcome_type":"secondary","measure":"Quality of Life Scale (QLS)"},{"outcome_type":"secondary","measure":"To analyze steady-state olanzapine plasma concentrations following 10, 20, and 40 mg daily dosing and examine the associations between state plasma levels, efficacy, and safety measures"},{"outcome_type":"secondary","measure":"To assess the safety between treatment arms and the safety dose-response relationship between the olanzapine treatment groups as determined by:"},{"outcome_type":"secondary","measure":"Treatment-emergent adverse events,"},{"outcome_type":"secondary","measure":"ECG"},{"outcome_type":"secondary","measure":"Vital signs and fasting laboratory analytes (clinical chemistry, hematology, lipid panel, and prolactin)"},{"outcome_type":"secondary","measure":"Appetite as measured by the Eating Behavior Assessment"},{"outcome_type":"secondary","measure":"Extrapyramidal symptoms as measured by the Modified Simpson-Angus Scale, The Barnes Akathisia Rating Scale, and the Abnormal Involuntary Movement Scale (AIMS)"}]}
{"nct_id":"NCT01057797","start_date":"2003-09-30","phase":"Phase 2","enrollment":208,"brief_title":"Nurse Managed Upper Body Strength Training in Chronic Obstructive Pulmonary Disease (COPD)","official_title":"Nurse Managed Upper Body Strength Training in COPD","primary_completion_date":"2009-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-01-31","last_update":"2010-01-27","description":"This is a four month exercise training program for people with chronic obstructive pulmonary disease (COPD)with a 12 month follow-up.","other_id":"NR08037","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  FEV1/FVC < 70 and FEV1 < 80%\r\n\r\n          -  > or = 45 years of age\r\n\r\n          -  Currently in stable clinical condition [free of respiratory tract infections for at\r\n             least two months prior to enrollment, no recent change in the color, consistency, or\r\n             quantity of sputum, afebrile and no recent change in medical therapy]\r\n\r\n          -  Taking appropriate medications according to the GOLD standards\r\n\r\n          -  Experience dyspnea with the use of their arms.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Evidence of restrictive lung disease or asthma\r\n\r\n          -  Acute respiratory infection\r\n\r\n          -  Taking oral corticosteroids on a regular basis\r\n\r\n          -  >3 exacerbations in the previous year\r\n\r\n          -  Evidence of significant depression (Hospital Anxiety Depression Scale >10)\r\n\r\n          -  Presence of a potentially debilitating disease such as cancer, congestive heart\r\n             failure, kidney disease, liver failure or cirrhosis, evidence of alcohol or drug\r\n             abuse, diabetes requiring insulin therapy, musculoskeletal or degenerative nerve\r\n             disease, etc.\r\n\r\n          -  Presence of a condition that would make it potentially unsafe to exercise, including a\r\n             history of a recent myocardial infarction, unstable angina pectoris, uncontrolled\r\n             cardiac arrhythmias causing symptoms or hemodynamic compromise, severe symptomatic\r\n             aortic stenosis, uncontrolled symptomatic heart failure, uncontrolled metabolic\r\n             disease, abnormal response to exercise test\r\n\r\n          -  Currently participating in pulmonary rehabilitation.\r\n      ","sponsor":"University of Illinois at Chicago","sponsor_type":"Other","conditions":"Chronic Obstructive Pulmonary Disease","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Exercise-specific self-efficacy","description":"Subjects in the experimental group will participate in a self-efficacy enhancing intervention designed to maximize (a) exercise-specific SE-UB strength training (b) self-efficacy for overcoming barriers to exercise and (c) SE-UB physical activities. The intervention incorporates strategies to maximize the primary sources of efficacy information: (a) mastery accomplishments, (b) social modeling, (c) social persuasion, (d) interpretation of physiological and affective symptoms."},{"intervention_type":"Behavioral","name":"Behavioral: Gentle chair exercise","description":"Gentle armchair fitness exercises will be used as a sham treatment to control for the attention that subjects receive in the two strength training groups. The armchair fitness exercises will be conducted in small groups (n=8-10 per group). Armchair exercises will include stretching of all major joints with an emphasis on the arms and shoulders, massage of muscles that can be reached from the armchair (scalp, neck, shoulders, lower back, abdomen and thighs) and imagery to promote relaxation. Each session will include: 5 minutes of slow stretching, 20 minutes of faster paced exercises, 5 minutes of slower paced stretches, followed by 5-10 minutes of massage and imagery for relaxation."},{"intervention_type":"Behavioral","name":"Behavioral: upper body strength training","description":"16 weeks of lab-based upper body strength training using 8: modified lateral pull down, shoulder shrug, upright row, overhead pull down, front raise, front pull down, triceps extension, biceps curl. Training load and volume will be increased progressing from 70% to 80% of the maximum strength training and from 2 sets of 8-10 repetitions progressing to 3 sets. Each week subjects will train twice in the lab and once at home. Home exercises will include 1 set of 15-20 repetitions: biceps curl, triceps extension, front raises, lateral raises, overhead press, chest press and one-arm dumbbell row."}],"outcomes":[{"outcome_type":"primary","measure":"Upper body strength","time_frame":"before training, after training, 6 months post training, 12 months post training"},{"outcome_type":"primary","measure":"Dyspnea","time_frame":"before training, after training, 6 months post training, 12 months post training"},{"outcome_type":"primary","measure":"Functional performance","time_frame":"before training, after training, 6 months post training, 12 months post training"},{"outcome_type":"secondary","measure":"Exercise adherence","time_frame":"before training, after training"}]}
{"nct_id":"NCT00243451","start_date":"2003-09-30","enrollment":34,"brief_title":"Early Detection of Mild Cognitive Impairment in Individual Patients","official_title":"Early Detection of Mild Cognitive Impairment in Individual Patients","primary_completion_date":"2011-07-31","study_type":"Observational","rec_status":"Completed","completion_date":"2011-07-31","last_update":"2011-09-07","description":"Our central hypothesis is that the early metabolic lesions of MCI can be reliably detected in individual subjects by objective analysis of [18]F-fluorodeoxyglucose (FDG) positron-emission tomography (PET) brain images, earlier and more accurately than by subjective clinician rating.","other_id":"LSUHSC H04-049","observational_model":"Case-Control","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":55,"maximum_age":85,"population":"Subjects must have a diagnosis of MCI or mild AD.","criteria":"\n        MCI Inclusion Criteria (patients):\r\n\r\n        MCI criteria met:\r\n\r\n          1. Memory complaint, preferably corroborated by an informant.\r\n\r\n          2. Objective memory impairment (based on cognitive test scores).\r\n\r\n          3. Normal general cognitive function.\r\n\r\n          4. Intact ADL.\r\n\r\n          5. Not demented.\r\n\r\n               -  At least 10 years of education, or GED, or equivalent.\r\n\r\n               -  Patients with ApoE4 positive homozygous or heterozygous status and/or\r\n                  first-degree relative with probable AD are preferred, but patients who meet all\r\n                  other criteria including well-defined MCI criteria will be accepted.\r\n\r\n               -  Age: 55-85\r\n\r\n               -  Have normal or clinically unimportant physical exam, beyond those consistent with\r\n                  a diagnosis of MCI.\r\n\r\n               -  Able to give informed consent, or assent and informed consent from a legal\r\n                  representative.\r\n\r\n               -  Centrally acting medications will be closely tracked, patients on any such\r\n                  medications will be PET-scanned only after a 24-hour washout, with meds restarted\r\n                  immediately after the scan.\r\n\r\n               -  Because depression and depressive pseudodementia are often prodromal to cognitive\r\n                  decline, these diagnoses will not be exclusive.\r\n\r\n               -  MRI findings must be normal or unremarkable for the age of the patient. Examples\r\n                  of abnormal (exclusory) findings are occult lacunar infarct, arteriovenous\r\n                  malformation) Examples of non-exclusory findings include mild atrophy, mild to\r\n                  moderate periventricular white matter changes. Other MRI findings will be\r\n                  evaluated in consultation with coinvestigator neuroradiologists and clinical\r\n                  judgment will be used to determine if the subject can continue in the study.\r\n\r\n        MCI Exclusion Criteria (patients):\r\n\r\n          -  Other neuropsychiatric diagnoses (e.g., stroke, head trauma, any psychotic disorder,\r\n             Parkinson's) other than MCI.\r\n\r\n          -  Major medical illness (e.g., diabetes, severe or uncontrolled hypertension),\r\n             especially potential secondary causes of cognitive decline (e.g., hypothyroidism).\r\n\r\n          -  Disease, combination of disease, or presentation that, in the clinician's judgment,\r\n             could introduce intolerable variance into the PET brain scan image (example: coronary\r\n             artery disease, hypercholesterolemia, on 5 medications, HTN 2 yrs controlled with\r\n             meds, random glucose of 125, but no Dx of DM, Hx of ?TIA).\r\n\r\n          -  Current substance or alcohol dependence or history of same, and no alcohol or\r\n             substance abuse within the last eight weeks.\r\n\r\n        Mild Alzheimer's Disease (AD) Inclusion criteria (patients):\r\n\r\n          1. You must have a Mini Mental State Examination score of greater than 20.\r\n\r\n          2. You must have one or more of these signs and symptoms of mild AD:\r\n\r\n        Cognitive impairment manifested as memory problems, problems with language, difficulty\r\n        carrying out motor activities, difficulty naming things, and/or problems planning or\r\n        organizing, all of which impair function and are worsening over time.\r\n\r\n          -  You must have at least 10 years of education, or a GED, or its equivalent.\r\n\r\n          -  We will be drawing blood to determine your ApoE genotype. ApoE4 is a risk factor for\r\n             Alzheimer's disease. We will share these results with you, if you desire to know the\r\n             results. ApoE4 is only a risk factor. That means it is possible to get Alzheimer's\r\n             without being ApoE4 positive, and it is possible to be ApoE4 positive and not get\r\n             Alzheimer's. If you are positive for the ApoE4 genetic marker, you can be included. If\r\n             you do NOT have the ApoE4 genetic marker, then you must have all other criteria.\r\n\r\n          -  Age: 55-85.\r\n\r\n          -  Normal or clinically unimportant physical exam, beyond those consistent with a\r\n             diagnosis of mild AD.\r\n\r\n          -  Able to give informed consent, or assent and informed consent from a legal\r\n             representative. You will be assessed for capacity and assent/consent obtained as\r\n             appropriate based on the Consensus Recommendations for Research Consent for\r\n             Cognitively Impaired Adults (2004, Alzheimer's Disease Association Disorder, 18\r\n             (3):171-175).\r\n\r\n          -  If you take medications that have an effect on the brain, they will be closely\r\n             monitored. You will be PET-scanned only after a 24-hour washout of this medication(s),\r\n             but this medication(s) will be restarted immediately after the scan.\r\n\r\n        Mild Alzheimer's Disease (AD) Exclusion Criteria:\r\n\r\n          -  Any problems related to the brain or mental disorders (e.g., stroke, head trauma, any\r\n             psychotic disorder, Parkinson's) other than mild AD. Some mood disorders will be\r\n             acceptable because depression is often a precursor to mild AD.\r\n\r\n          -  You will get an MRI of your brain taken on the second visit, and a radiologist will\r\n             read it. If there are any abnormal findings, you will be told, and these findings will\r\n             be forwarded to your medical doctor. These findings may or may not result in your\r\n             exclusion from the study.\r\n\r\n          -  Any major medical illness (e.g., diabetes, severe or uncontrolled hypertension),\r\n             especially potential secondary causes of cognitive decline (e.g., hypothyroidism).\r\n\r\n          -  Any disease, combination of disease, or presentation that, in the clinician's\r\n             judgment, could introduce intolerable variance into the PET brain scan image.\r\n\r\n          -  Current diagnosis of substance or alcohol dependence or a history of same, and no\r\n             alcohol or substance abuse within the last eight weeks.\r\n\r\n        MCI Inclusion criteria (controls)\r\n\r\n          -  Normal cognitive screening exam.\r\n\r\n          -  Age: 55-85.\r\n\r\n          -  At least 10 years of education or GED, or equivalent.\r\n\r\n          -  Socioeconomic status, age, and sex matched. Able to give informed consent, or assent\r\n             and informed consent from a legal representative.\r\n\r\n          -  Centrally acting medications will be closely tracked, patients on any such medications\r\n             will be PET-scanned only after a 24-hour washout, with meds restarted immediately\r\n             after the scan.\r\n\r\n        MCI Exclusion criteria (controls)\r\n\r\n          -  First-degree relative with dementia or clinically relevant memory problems.\r\n\r\n          -  Neuropsychiatric diagnoses (e.g., stroke, head trauma, depression, any psychoses).\r\n\r\n          -  Major medical illness (e.g., diabetes, severe /uncontrolled hypertension,\r\n             hypothyroidism).\r\n\r\n          -  Current substance or alcohol dependence or history of same, and no alcohol or\r\n             substance abuse within the last eight weeks.\r\n\r\n          -  MRI findings must be normal or unremarkable for the age of the patient. Examples of\r\n             abnormal (exclusory) findings are occult lacunar infarct, arteriovenous malformation)\r\n             Examples of non-exclusory findings include mild atrophy, mild to moderate\r\n             periventricular white matter changes. Other MRI findings will be evaluated in\r\n             consultation with coinvestigator neuroradiologists and clinical judgment will be used\r\n             to determine if the subject can continue in the study.\r\n\r\n               -  Disease, combination of disease, or presentation that, in the clinician's\r\n                  judgment, could introduce intolerable variance into the PET brain scan image\r\n                  (example: coronary artery disease, hypercholesterolemia, on 5 medications, HTN 2\r\n                  yrs controlled with meds, random glucose of 125, but no Dx of DM, Hx of ?TIA).\r\n\r\n        Dropout criteria (all):\r\n\r\n        Subjects that begin the study and are not able to finish the study will be tracked. Ongoing\r\n        criteria for termination from the study will include:\r\n\r\n          -  Adverse events intolerable to the patient that prevent continued involvement in the\r\n             study.\r\n\r\n          -  New onset medical disorder of such significance as to prohibit further involvement.\r\n\r\n          -  Initiation or recurrence of alcohol or substance abuse/dependence.\r\n\r\n          -  Subject withdraws consent for any reason.\r\n      ","sponsor":"Louisiana State University Health Sciences Center Shreveport","sponsor_type":"Other","conditions":"Mild Cognitive Impairment|Mild Alzheimer's Disease","interventions":[{"intervention_type":"Other","name":"Other: PET scan & fMRI","description":"Subjects will be screened and if applicable for the study will be scheduled for an MRI. At the third visit they will complete the PET scan. They will return at 6, 12, 24, and 36 months and complete another PET scan at the last visit."}],"outcomes":[{"outcome_type":"primary","measure":"Determine if the Cognitive Decline Index will discriminate subtle lesions earlier than the standard analysis of the Nuclear Medicine physician.","time_frame":"within the next 3 years"},{"outcome_type":"secondary","measure":"Determine if sensitivity, specificity, receiver-operator characteristics, and predictive value of our method are appropriate for translation into a clinically useful tool.","time_frame":"within the next three years"}]}
{"nct_id":"NCT00836901","start_date":"2003-09-30","phase":"Phase 1","enrollment":52,"brief_title":"Amoxicillin-Clavulanic Acid 400 mg-57 mg Chewable Tablets Under Non-Fasting Conditions","official_title":"Randomized, 2-Way Crossover, Bioequivalence Study of Amoxicillin-Clavulanic Acid 400 mg-57 mg Chewable Tablets and AUGMENTIN 400 mg-57 mg Chewable Tablets Administered as 1 x 400 mg-57 mg Chewable Tablet in Healthy Subjects Under Fed Conditions","primary_completion_date":"2003-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2003-09-30","last_update":"2009-08-18","description":"The objective of this study is to compare the rate and extent of absorption of amoxicillin-clavulanic acid 400 mg-57 mg chewable tablets (test) versus Augmentin (reference) administered as 1 x 400 mg-57 mg chewable tablet under fed conditions.","other_id":"30074","allocation":"Randomized","intervention_model":"Crossover Assignment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria\r\n\r\n          -  Subjects will be females and/or males, non-smokers, 18 years of age and older.\r\n\r\n        Exclusion Criteria\r\n\r\n          -  Clinically significant illnesses within 4 weeks of the administration of study\r\n             medication.\r\n\r\n          -  Clinically significant surgery within 4 weeks prior to the administration of the study\r\n             medication.\r\n\r\n          -  Any clinically significant abnormality found during medical screening.\r\n\r\n          -  Any reason which, in the opinion of the medical subinvestigator, would prevent the\r\n             subject from participating in the study.\r\n\r\n          -  Abnormal laboratory tests judged clinically significant.\r\n\r\n          -  Positive urine drug screen at screening.\r\n\r\n          -  Positive testing for hepatitis B, hepatitis C or HIV at screening.\r\n\r\n          -  ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood\r\n             pressure lower than 90 or over 140 mmHg, or diastolic blood pressure lower than 50 or\r\n             over 90; or heart rate less than 50 bpm) at screening.\r\n\r\n          -  Subjects with BMI 30.0.\r\n\r\n          -  History of significant alcohol abuse within six months of the screening visit or any\r\n             indication of the regular use of more than two units of alcohol per day (1 Unit = 150\r\n             mL of wine or 360 mL of beer or 45 mL of alcohol 40%).\r\n\r\n          -  History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana)\r\n             within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine\r\n             (PCP) and crack) within 1 year of the screening visit.\r\n\r\n          -  Any food allergy, intolerance, restriction or special diet that, in the opinion of the\r\n             medical subinvestigator, contraindicates the subject's participation in this study.\r\n\r\n          -  History of allergic or hypersensitivity reactions to amoxicillin or clavulanic acid or\r\n             other related drugs (e.g. penicillin, cephalosporins, cephamycins).\r\n\r\n          -  Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of\r\n             inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin;\r\n             examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin,\r\n             ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine, valproic acid) use\r\n             of an investigational drug or participation on an investigation study within 30 days\r\n             prior to the administration of the study medication.\r\n\r\n          -  Clinically significant history or presence of any clinically significant\r\n             gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases),\r\n             unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney\r\n             disease, or other conditions known to interfere with the absorption, distribution,\r\n             metabolism, or excretion of the drug.\r\n\r\n          -  Any clinically significant history or presence of clinically significant neurological,\r\n             endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or\r\n             metabolic disease.\r\n\r\n          -  Any food allergy, intolerance, restriction or special diet that could, in the opinion\r\n             of the Medical Subinvestigator, contraindicate the subject's participation in this\r\n             study.\r\n\r\n          -  Use of prescription medication within 14 days prior to administration of study\r\n             medication or over-the-counter products )including natural products, vitamins, garlic\r\n             as a supplement) within 7 days prior to administration of study medication, except for\r\n             topical products without systemic absorption.\r\n\r\n          -  Subjects who have had a depot injection or an implant of any drug 3 months prior to\r\n             administration of study medication.\r\n\r\n          -  Donation of plasma (500 mL) within 7 days. Donation or loss of whole blood prior to\r\n             administration of the study medication as follows:\r\n\r\n               -  less than 300 mL of whole blood within 30 days, or\r\n\r\n               -  300 mL to 500 mL of whole blood within 45 days, or\r\n\r\n               -  more than 500 mL of whole blood within 56 days.\r\n\r\n          -  Positive alcohol breath test at screening.\r\n\r\n          -  Subjects who have used tobacco in any form within the 90 days preceding study drug\r\n             administration.\r\n\r\n          -  Intolerance to venipunctures.\r\n\r\n          -  Subjects with a clinically significant history of tuberculosis, epilepsy, asthma,\r\n             diabetes, psychosis, or glaucoma will not be eligible for this study.\r\n\r\n          -  Any history of known Augmentin-associated cholestatic jaundice/hepatic dysfunction\r\n\r\n          -  Any known active mononucleosis\r\n\r\n          -  Subjects with dentures or braces.\r\n\r\n        Additional exclusion criteria for female subjects only:\r\n\r\n          -  Breast feeding subjects.\r\n\r\n          -  Positive urine pregnancy test at screening (performed on all females).\r\n      ","sponsor":"Teva Pharmaceuticals USA","sponsor_type":"Industry","conditions":"Healthy","interventions":[{"intervention_type":"Drug","name":"Drug: amoxicillin-clavulanic acid","description":"400 mg-57 mg chewable tablet"},{"intervention_type":"Drug","name":"Drug: Augmentin","description":"400 mg-57 mg chewable tablet"}],"outcomes":[{"outcome_type":"primary","measure":"AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Clavunlanic Acid","time_frame":"Blood samples collected over 10 hour period","description":"Bioequivalence based on AUC0-inf"},{"outcome_type":"primary","measure":"Cmax (Maximum Observed Concentration) - Amoxicillin","time_frame":"Blood samples collected over 10 hour period","description":"Bioequivalence based on Cmax"},{"outcome_type":"primary","measure":"AUC0-inf - [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Amoxicillin","time_frame":"Blood samples collected over 10 hour period","description":"Bioequivalence based on AUC0-inf"},{"outcome_type":"primary","measure":"AUC0-t - [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Amoxicillin","time_frame":"Blood samples collected over 10 hour period","description":"Bioequivalence based on AUC0-t"},{"outcome_type":"primary","measure":"Cmax (Maximum Observed Concentration) - Clavulanic Acid","time_frame":"Blood samples were collected over 10 hour period","description":"Bioequivalence based on Cmax"},{"outcome_type":"primary","measure":"AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Clavulanic Acid","time_frame":"Blood samples collected over 10 hour period","description":"Bioequivalence based on AUC0-t"}]}
{"nct_id":"NCT00092378","start_date":"2003-09-01","phase":"Phase 3","enrollment":251,"brief_title":"A Study of Two Approved Drugs in the Treatment of Post-Bunionectomy Surgery Pain (0966-234)(COMPLETED)","official_title":"A Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled, Parallel-Group Study of Rofecoxib and Diclofenac Sodium in the Treatment of Post-Bunionectomy Surgery Pain","primary_completion_date":"2003-12-01","study_type":"Interventional","rec_status":"Completed","completion_date":"2003-12-01","last_update":"2017-05-09","description":"This purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following bunionectomy surgery.","other_id":"0966-234","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Bunion removal\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any known allergies to the study design\r\n      ","sponsor":"Merck Sharp & Dohme Corp.","sponsor_type":"Industry","conditions":"Postoperative Pain","interventions":[{"intervention_type":"Drug","name":"Drug: MK0966, rofecoxib"},{"intervention_type":"Drug","name":"Drug: Comparator: diclofenac sodium, placebo"}],"outcomes":[{"outcome_type":"primary","measure":"Overall analgesic effect over 8 hours"},{"outcome_type":"secondary","measure":"Time to onset of analgesic effect."},{"outcome_type":"secondary","measure":"The use of supplemental analgesia on Days 2-3."},{"outcome_type":"secondary","measure":"Peak analgesic effect on Day 1."},{"outcome_type":"secondary","measure":"Overall safety and tolerability."},{"outcome_type":"secondary","measure":"The analgesic effect on Days 2-3."}]}
{"nct_id":"NCT00071968","start_date":"2003-08-31","phase":"Phase 2","enrollment":15,"brief_title":"Neoadjuvant CCI-779 Followed By Radical Prostatectomy in Treating Patients With Newly Diagnosed Prostate Cancer Who Have a High Risk of Relapse","official_title":"An Open-Label Study Of Exploratory Pharmacogenomics And Pharmacologic Effects Of Neoadjuvant Oral CCI-779 In Newly Diagnosed Prostate Cancer Patients Undergoing Radical Prostatectomy Who Have A High Risk Of Relapse","primary_completion_date":"2006-05-31","study_type":"Interventional","rec_status":"Completed","last_update":"2013-01-08","description":"RATIONALE: Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving CCI-779 before surgery may shrink the tumor so that it can be removed. PURPOSE: This randomized phase II trial is studying how well CCI-779 works in treating patients who are undergoing radical prostatectomy for newly diagnosed prostate cancer at high risk of relapse.","other_id":"CDR0000331979","allocation":"Randomized","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":18,"population":"","criteria":"\n        DISEASE CHARACTERISTICS:\r\n\r\n          -  Histologically confirmed adenocarcinoma of the prostate\r\n\r\n               -  Diagnosis based on a minimum of 6 core biopsy samples\r\n\r\n               -  Clinically confirmed organ-confined disease\r\n\r\n          -  Candidate for radical prostatectomy\r\n\r\n          -  No evidence of metastatic disease by CT scan and bone scan\r\n\r\n          -  High risk of relapse based on either of the following criteria:\r\n\r\n               -  Any one of the following:\r\n\r\n                    -  Stage T2C or higher\r\n\r\n                    -  Gleason score greater than 7\r\n\r\n                    -  Prostate-specific antigen (PSA) greater than 20 ng/mL OR\r\n\r\n               -  Any two of the following:\r\n\r\n                    -  Gleason score at least 7\r\n\r\n                    -  PSA 10-20 ng/mL\r\n\r\n                    -  Greater than 50% of total biopsy cores with cancer involvement\r\n\r\n        PATIENT CHARACTERISTICS:\r\n\r\n        Age\r\n\r\n          -  18 and over\r\n\r\n        Performance status\r\n\r\n          -  ECOG 0-1\r\n\r\n        Life expectancy\r\n\r\n          -  Not specified\r\n\r\n        Hematopoietic\r\n\r\n          -  No active bleeding\r\n\r\n          -  Absolute neutrophil count at least 1,500/mm^3\r\n\r\n          -  Platelet count at least 100,000/mm^3\r\n\r\n          -  Hemoglobin at least 10 g/dL\r\n\r\n        Hepatic\r\n\r\n          -  No acute or chronic hepatitis B\r\n\r\n               -  Hepatitis B surface antigen negative\r\n\r\n          -  No acute or chronic hepatitis C\r\n\r\n               -  No antibodies to hepatitis C\r\n\r\n          -  Bilirubin no greater than 1.5 times upper limit of normal (ULN)\r\n\r\n          -  AST and ALT no greater than 2 times ULN\r\n\r\n        Renal\r\n\r\n          -  No ongoing urinary tract infection necessitating rapid or emergent surgical resection\r\n\r\n          -  Creatinine no greater than 1.5 times ULN\r\n\r\n        Cardiovascular\r\n\r\n          -  No unstable angina\r\n\r\n          -  No myocardial infarction within the past 6 months\r\n\r\n          -  No life-threatening ventricular arrhythmia requiring ongoing maintenance therapy\r\n\r\n        Pulmonary\r\n\r\n          -  No known pulmonary hypertension\r\n\r\n          -  No pneumonitis\r\n\r\n        Other\r\n\r\n          -  Fertile patients must use effective contraception during and for 12 weeks after study\r\n             participation\r\n\r\n          -  HIV negative\r\n\r\n          -  No other severe immunocompromised states\r\n\r\n          -  No active infection requiring antibiotic therapy\r\n\r\n          -  No serious concurrent illness\r\n\r\n          -  No other major illness that would substantially increase the risk associated with\r\n             study participation\r\n\r\n          -  No other malignancy within the past 5 years except basal cell or squamous cell skin\r\n             cancer\r\n\r\n        PRIOR CONCURRENT THERAPY:\r\n\r\n        Biologic therapy\r\n\r\n          -  No concurrent immunotherapy\r\n\r\n        Chemotherapy\r\n\r\n          -  No prior chemotherapy\r\n\r\n          -  No other concurrent chemotherapy\r\n\r\n        Endocrine therapy\r\n\r\n          -  More than 3 weeks since prior IV corticosteroids\r\n\r\n          -  No concurrent systemic corticosteroids\r\n\r\n          -  No prior or concurrent hormonal therapy for underlying malignancy\r\n\r\n        Radiotherapy\r\n\r\n          -  No prior or concurrent radiotherapy\r\n\r\n        Surgery\r\n\r\n          -  More than 3 months since prior major surgery\r\n\r\n        Other\r\n\r\n          -  More than 1 month since prior experimental drugs\r\n\r\n          -  More than 3 weeks since prior immunosuppressive agents\r\n\r\n          -  No concurrent immunosuppressive therapies\r\n\r\n          -  No other concurrent investigational agents\r\n\r\n          -  No concurrent enzyme-inducing anticonvulsants (e.g., phenobarbital, phenytoin, or\r\n             carbamazepine)\r\n\r\n          -  No concurrent ketoconazole, diltiazem, rifampin, terfenadine, cisapride, astemizole,\r\n             pimozide, or Hypericum perforatum (St. John's wort)\r\n\r\n          -  No concurrent grapefruit or grapefruit juice\r\n      ","sponsor":"Jonsson Comprehensive Cancer Center","sponsor_type":"Other","conditions":"Prostate Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: temsirolimus"},{"intervention_type":"Procedure","name":"Procedure: conventional surgery"},{"intervention_type":"Procedure","name":"Procedure: neoadjuvant therapy"}],"outcomes":[{"outcome_type":"primary","measure":"Phosphorylation state of proteins"},{"outcome_type":"primary","measure":"p70S6 kinase activity"},{"outcome_type":"primary","measure":"Phosphorylation state of mTOR pathway proteins"},{"outcome_type":"primary","measure":"Global and targeted gene expression patterns in peripheral blood mononuclear cells"},{"outcome_type":"secondary","measure":"Global and targeted gene expression patterns"},{"outcome_type":"secondary","measure":"Pharmacodynamics and pharmacogenomic surrogate markers"},{"outcome_type":"secondary","measure":"Antitumor effects"},{"outcome_type":"secondary","measure":"Pharmacokinetics"},{"outcome_type":"secondary","measure":"Correlation of phosphatase and tensin homolog gene status with pharmacodynamic and pharmacogenomic effects"},{"outcome_type":"secondary","measure":"Protein expression patterns in the plasma"}]}
{"nct_id":"NCT00913250","start_date":"2003-08-31","phase":"Phase 1","enrollment":96,"brief_title":"A Bioequivalence Study of Serum Free Avonex and Serum Containing Avonex in Healthy Volunteers","official_title":"A Randomized, Single-Blind, Crossover Study in Healthy Volunteers to Demonstrate the Bioequivalence of AVONEX (Interferon Beta-1a) Solutions for Injection Produced by a Serum-Containing Manufacturing Process and by a Serum-Free Manufacturing Process","study_type":"Interventional","rec_status":"Completed","completion_date":"2003-10-31","last_update":"2009-06-04","description":"Demonstrate the bioequivalence of a serum-free solution to a serum containing solution of Avonex.","other_id":"C-869","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Basic Science","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy Volunteers\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of severe allergic or anaphylactic reactions\r\n\r\n          -  History of hypersensitivity to acetaminophen (paracetamol), ibuprofen, or codeine.\r\n\r\n          -  Known allergy to dry natural rubber\r\n\r\n          -  History of seizure disorder or unexplained blackouts\r\n\r\n          -  History of any clinically significant (as determined by the Investigator) cardiac,\r\n             endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary,\r\n             neurologic, dermatologic, psychiatric, renal, and/or other major disease\r\n\r\n        Other inclusion and exclusion criteria apply as per protocol\r\n      ","sponsor":"Biogen","sponsor_type":"Industry","conditions":"Multiple Sclerosis","interventions":[{"intervention_type":"Drug","name":"Drug: Serum containing Avonex","description":"60mcg IM dose of serum containing Avonex on Day 1, followed by 60mcg IM dose of serum free Avonex on Day 15"},{"intervention_type":"Drug","name":"Drug: Serum Free Avonex","description":"60mcg IM dose of serum free Avonex on Day 1, followed by 60mcg IM dose of serum containing Avonex on Day 15."}],"outcomes":[{"outcome_type":"primary","measure":"To demonstrate the bioequivalence of a serum-free Avonex and a serum-containing AVONEX® when given intramuscularly (IM) to healthy volunteers.","time_frame":"Study duration is 72 days"}]}
{"nct_id":"NCT00191178","start_date":"2003-08-31","phase":"Phase 4","enrollment":60,"brief_title":"Effects of Insulin in Perceived Mood Symptoms in Patients With Type 2 Diabetes","official_title":"Pilot Study Investigating the Effects of Insulin Lispro Low Mixture Therapy Compared With Insulin Glargine on Perceived Mood Symptoms in Patients With Type 2 Diabetes Mellitus","study_type":"Interventional","rec_status":"Completed","completion_date":"2005-07-31","last_update":"2010-10-13","description":"This study investigates the influence of two different insulin regimens, twice-daily insulin lispro low mix (LM) and once-daily insulin glargine, on perceived physical, mood, and cognitive symptoms as well as cognitive-motor task performance in patients with type 2 diabetes.","other_id":"4957","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":21,"maximum_age":79,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosed as having type 2 diabetes mellitus, as defined by the World Health\r\n             Organization\r\n\r\n          -  Are being treated with metformin therapy alone, metformin therapy plus once-daily\r\n             insulin, or metformin plus one or more other oral antihyperglycemic agents at the time\r\n             of study entry\r\n\r\n          -  Female patients not breastfeeding and female patients of childbearing potential must\r\n             test negative for pregnancy at time of study entry based on a urine pregnancy test and\r\n             do not intend to become pregnant during the study and agree to use a reliable form of\r\n             birth control during the study\r\n\r\n          -  Hemoglobin A1c greater than or equal to 7.0% and less than or equal to 10% within 3\r\n             months prior to visit 1\r\n\r\n          -  Have given informed consent to participate in the study in accordance with local\r\n             regulations\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Are investigator site personnel directly affiliated with the study, or are immediate\r\n             family of investigator site personnel directly affiliated with the study.\r\n\r\n          -  Have received treatment within the last 30 days with a drug that has not received\r\n             regulatory approval for any indication at the time of study entry\r\n\r\n          -  Have previously been diagnosed with clinical depression or have been treated with a\r\n             central nervous system stimulant, antidepressant, antipsychotic, or anxiolytic agent\r\n             within 30 days prior to study entry\r\n\r\n          -  Have a known allergy to insulin lispro low mixture, insulin glargine, metformin\r\n             hydrochloride, or excipients contained in these products\r\n\r\n          -  Have known hypersensitivity or contraindication to metformin hydrochloride\r\n      ","sponsor":"Eli Lilly and Company","sponsor_type":"Industry","conditions":"Type 2 Diabetes","interventions":[{"intervention_type":"Drug","name":"Drug: insulin lispro protamine suspension:insulin lispro rDNA origin low mix"},{"intervention_type":"Drug","name":"Drug: insulin glargine"}],"outcomes":[{"outcome_type":"primary","measure":"Compare twice-daily insulin lispro Low Mix therapy and once-daily insulin glargine therapy with respect to perceived mood on patient-rated questionnaires following chronic treatment administration in patients with type 2 diabetes"},{"outcome_type":"primary","measure":"Instruments used/tests performed:hand held computers to rate a series of 13 symptoms;hand held computers to administer a series of cognitive-motor performance tests;blood glucose testing"},{"outcome_type":"secondary","measure":"Compare insulin lispro Low Mix therapy and insulin glargine therapy with respect to:scores (collective and specific) on patient-rated mood, physical, and cognitive symptoms;scores on specific cognitive-motor performance tests"},{"outcome_type":"secondary","measure":"physical energy level as reflected by subjective symptoms, self-report of activity level, and physical motion as reflected by a pedometer worn at the waist"},{"outcome_type":"secondary","measure":"specific measures of depression, according to the Beck Depression Inventory-II"},{"outcome_type":"secondary","measure":"blood glucose rate of change;eight-point self-monitored blood glucose profile;episodes of hypoglycemia, including episodes of severe hypoglycemia"}]}
{"nct_id":"NCT00194246","start_date":"2003-08-31","enrollment":29,"brief_title":"Cognitive Function and Cue-Reactivity Study","official_title":"Cognitive Performance and Food Reactivity During High and Low Carbohydrate Obesity Treatment","primary_completion_date":"2010-03-31","study_type":"Observational","rec_status":"Completed","completion_date":"2010-03-31","last_update":"2013-07-01","description":"We are interested in testing differences in cognitive function and food reactivity at various time points in individuals following low and high carbohydrate diets. We wish to achieve an understanding of these time-specific differences using repeated measures analysis of variance (ANOVA), with diet condition (low vs. high carbohydrate) as a between subject factor and time as a within-subject factor.","other_id":"R01AT001103-01","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":65,"population":"all participants who took part in the Safety and Efficacy of Low and High Carbohydrate\r\n        Diets study","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Body mass index between 30 and 40\r\n\r\n          -  Live and work within 1 hour of the study site\r\n\r\n          -  Stable psychological status\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of heart disease, heart attack, or stroke\r\n\r\n          -  Blood pressure > 140/90 mmHG\r\n\r\n          -  Abnormal cholesterol levels\r\n\r\n          -  Significant psychiatric illness\r\n\r\n          -  Any medication that affects weight or metabolic rate\r\n\r\n          -  Presence or history of a chronic disease that is known to affect appetite, food\r\n             intake, or metabolism (i.e. diabetes, thyroid disease or cancer).\r\n\r\n          -  Currently using antidepressants, steroids, tobacco or illegal drugs\r\n\r\n          -  Pregnant, breastfeeding, or planning pregnancy\r\n\r\n          -  10 lb change in weight within 6 months of study entry\r\n\r\n          -  History of malignant arrhythmias or cerebrovascular, renal, or hepatic disease\r\n\r\n          -  History of protein wasting diseases or gout\r\n\r\n          -  Severe arthritis\r\n\r\n          -  Osteoporosis\r\n\r\n          -  Certain types of hormone replacement therapy\r\n\r\n          -  Currently following a vegetarian diet\r\n      ","sponsor":"Temple University","sponsor_type":"Other","conditions":"Cognitive Performance|Food Cravings","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"the relationships between cognitive and physiological reactivity to food and non-food cues","time_frame":"2 year period"}]}
{"nct_id":"NCT00340756","start_date":"2003-08-06","enrollment":60,"brief_title":"Evaluating Serum Sex Steroid Hormones","official_title":"Reproducibility of Serum Sex Steroid Measurement: A Proof of Performance Study","study_type":"Observational","rec_status":"Completed","completion_date":"2011-02-25","last_update":"2017-07-02","description":"The purpose of this study is to evaluate the reproducibility of measurements of sex hormone levels in serum samples. Researchers will collect blood from 60 healthy adults, including 20 men, 20 premenopausal women, and 20 postmenopausal women. Blood samples will be collected after study participants have fasted overnight.","other_id":"999903274","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":75,"population":"","criteria":"\n        -  INCLUSION CRITERIA:\r\n\r\n        We plan to recruit healthy men aged 50-65 from Westat employees and family and friends of\r\n        Westat employees.\r\n\r\n        One month later we will recruit 20 pre menopausal women (aged 20-40) and 20 post menopausal\r\n        women (aged 55-75).\r\n      ","sponsor":"National Cancer Institute (NCI)","sponsor_type":"NIH","conditions":"Validation","interventions":{},"outcomes":{}}
{"nct_id":"NCT00195364","start_date":"2003-07-31","enrollment":93,"brief_title":"Study Evaluating Etanercept in Patients With Rheumatoid Arthritis Who Completed Trial 0881A1-301-EU in Spain","official_title":"Long-Term Safety Study of Etanercept in Patients With Rheumatoid Arthritis Who Completed Trial 0881A1-301-EU in Spain","primary_completion_date":"2008-10-31","study_type":"Observational","rec_status":"Completed","completion_date":"2008-10-31","last_update":"2009-06-04","description":"The purpose of this study is to evaluate long-term safety of etanercept in patients with rheumatoid arthritis who successfully have completed open-label safety study 0881A1-301-EU","other_id":"0881A1-301, 101492","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"Patients with rheumatoid arthritis who completed trial 0881A1-301-EU in Spain who fulfill\r\n        inclusion/exclusion criteria, treated in rheumatology units","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  To have completed 0881A1-301-EU study in Spain\r\n\r\n          -  Clinical diagnosis by ACR revised criteria of rheumatoid arthritis.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Hypersensibility to etanercept or any of its components\r\n\r\n          -  Significant concurrent medical disease\r\n      ","sponsor":"Wyeth is now a wholly owned subsidiary of Pfizer","sponsor_type":"Industry","conditions":"Rheumatoid Arthritis|Inflammation","interventions":[{"intervention_type":"Drug","name":"Drug: Etanercept"}],"outcomes":{}}
{"nct_id":"NCT00616343","start_date":"2003-06-30","phase":"N/A","enrollment":9,"brief_title":"Zonisamide in the Treatment of Essential Tremor","official_title":"Pilot Study of Zonisamide in the Treatment of Essential Tremor","primary_completion_date":"2012-10-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2012-12-31","last_update":"2014-07-17","description":"The purpose of this study is to determine if Zonisamide is effective in reducing tremors in patients with Essential Tremor.","other_id":"OSR#53157","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Diagnosis of Essential Tremor based on the Tremor Investigational Group criteria for\r\n             definite or probable Essential Tremor.\r\n\r\n          2. Age: 18 years or over.\r\n\r\n          3. Willingness and ability to comply with the study requirements and give informed\r\n             consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Known history of psychiatric disorder, major depression, dementia, aplastic anemia, or\r\n             Stevens-Johnson syndrome.\r\n\r\n          2. Known alcohol or substance abuse in previous 12 months.\r\n\r\n          3. Positive pregnancy test.\r\n\r\n          4. Unwillingness to use adequate contraceptive methods if of childbearing potential.\r\n\r\n          5. Known allergy to sulfonamides.\r\n\r\n          6. Laboratory abnormalities prior to onset of trial.\r\n      ","sponsor":"Loma Linda University","sponsor_type":"Other","conditions":"Essential Tremor","interventions":[{"intervention_type":"Drug","name":"Drug: Zonisamide","description":"100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks."}],"outcomes":[{"outcome_type":"primary","measure":"Tremor Severity","time_frame":"4 weeks","description":"PI has left the institution and we are unable to accurately assess the data from the remaining records."}]}
{"nct_id":"NCT00064493","start_date":"2003-06-30","brief_title":"Modeling DNA Diversity in Reverse Cholesterol Transport","primary_completion_date":"2008-05-31","study_type":"Observational","rec_status":"Completed","completion_date":"2008-05-31","last_update":"2008-07-02","description":"To identify genetic variation in reverse cholesterol transport (RCT) and its role in cardiovascular disease and atherosclerosis.","other_id":"1223","sampling_method":"","gender":"All","population":"","criteria":"\n        No eligibility criteria\r\n      ","sponsor":"National Heart, Lung, and Blood Institute (NHLBI)","sponsor_type":"NIH","conditions":"Cardiovascular Diseases|Heart Diseases|Atherosclerosis","interventions":{},"outcomes":{}}
{"nct_id":"NCT00995306","start_date":"2003-06-30","phase":"Phase 3","enrollment":695,"brief_title":"Evaluating the Safety and Efficacy Civamide in Osteoarthritis (OA) of the Knee(s)","official_title":"A Double-Blind, Randomized, Controlled, Parallel-Group, Multicenter Study Evaluating the Safety and Efficacy of Civamide Cream 0.075% as a Treatment in Subjects With Osteoarthritis of the Knee","primary_completion_date":"2004-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2004-06-30","last_update":"2011-06-10","description":"To evaluate the safety and efficacy of Civamide Cream 0.075% as a treatment of the signs and symptoms associated with osteoarthritis of the knee.","other_id":"WL-1001-05-01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Quadruple","sampling_method":"","gender":"All","minimum_age":40,"maximum_age":76,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Subject voluntarily agrees to participate in this study and signs an IRB-approved\r\n             informed consent prior to entry into the Screening Period (Day -3).\r\n\r\n          2. Subject has OA pain of the Target Knee with a WOMAC Pain Subscale baseline value of >\r\n             9 at the Baseline/Randomization Period (Maximum score is 20 for 5 questions with 0 =\r\n             none; 4 = extreme.\r\n\r\n          3. Subject must have a Functional Capacity Classification of I-III.\r\n\r\n          4. Subject has taken a stable dose of NSAIDs or COX-2 inhibitor agents for OA pain for at\r\n             least 22 of the previous 28 days and for each of the 2 days prior to the Screening\r\n             Period (Day -3) and for at least each of the 2 days prior to the\r\n             Baseline/Randomization Period (Day 1). Subject must also, agree and be expected to\r\n             remain on this stable daily dose throughout the study.\r\n\r\n          5. Subject is between 40-75 years of age.\r\n\r\n          6. Diagnosis of OA is present for at least 6 months according to the ACR criteria for OA\r\n             of the knee.\r\n\r\n          7. Radiographic evidence of OA of the Target Knee (within the last 3 years) with a\r\n             Kellgren-Lawrence scale of 2 or 3.\r\n\r\n          8. Subject is generally in good health.\r\n\r\n          9. Subject is expected to be compliant with study procedures.\r\n\r\n         10. Females of child-bearing potential must have a negative urine pregnancy test at\r\n             Screening.\r\n\r\n         11. Female subjects of child-bearing potential agree to use an approved form of\r\n             contraception and must be on the same contraceptive method and dosage schedule during\r\n             the entire study.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Presence of tendonitis, bursitis, partial or complete joint replacement of Target\r\n             Knee.\r\n\r\n          2. Presence of active skin disease, erythema, infection, wound or irritation near the\r\n             treatment area of the Target Knee.\r\n\r\n          3. Subject has history of frequent headache or other painful conditions (other than OA)\r\n             that is expected to require any use of systemic opiates or derivatives, or more than\r\n             twice a week additional administration of different oral NSAIDs or COX-2 inhibitors\r\n             (see Section 6.1, Table 2).\r\n\r\n          4. Subject experiences regular significant pain due to osteoarthritis or other conditions\r\n             in the non-target knee or other joints while on stable doses of their current\r\n             analgesic therapy.\r\n\r\n          5. Subject has an anticipated need for any surgical or other invasive procedure that will\r\n             be performed on the Target Knee or other part of the body during the course of the\r\n             study.\r\n\r\n          6. OA secondary to local joint disorders (e.g., mechanical disorder, internal derangement\r\n             of the knee), systemic metabolic disease, endocrine disorders, bony dysplasia, calcium\r\n             crystal deposition disease, neuropathic arthropathy, frostbite, congenital\r\n             abnormalities.\r\n\r\n          7. Subject has history and/or diagnosis of rheumatoid arthritis, fibromyalgia, connective\r\n             tissue disease, psoriatic arthritis, erosive inflammatory OA, diffuse idiopathic\r\n             skeletal hyperostosis, severe neurologic or vascular disease.\r\n\r\n          8. Subject has active (redness, swelling, fever, etc.) gout/pseudogout within 6 months\r\n             prior to screening.\r\n\r\n          9. Subject has Type I or Type II diabetes with peripheral neuropathies.\r\n\r\n         10. Subject is extremely obese with BMI  39.\r\n\r\n         11. Subject has had trauma to or surgery on the Target Knee within 1 year of\r\n             Screening/Baseline.\r\n\r\n         12. Subject has an underlying clinical condition, including previous malignancies that in\r\n             the Investigator's judgment, is unstable.\r\n\r\n         13. Subject has known allergy or hypersensitivity to capsicum, civamide, or\r\n             capsaicin-containing products or any constituent of the cream formulation.\r\n\r\n         14. Subject has a history of substance abuse within the past 12 months.\r\n\r\n         15. Subject has participated in previous clinical study with Civamide Cream.\r\n\r\n         16. Use of restricted medications (See Medication/Treatment Table, Section 5.1.2).\r\n      ","sponsor":"Winston Laboratories","sponsor_type":"Industry","conditions":"Osteoarthritis of the Knee","interventions":[{"intervention_type":"Drug","name":"Drug: Civamide (Zucapsaicin)","description":"Civamide Cream 0.075%, TID for 12 weeks\r\nCivamide Cream 0.01%, TID for 12 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain"},{"outcome_type":"primary","measure":"WOMAC Physical Function"},{"outcome_type":"primary","measure":"Subject's Global Evaluation"}]}
{"nct_id":"NCT00066391","start_date":"2003-06-30","phase":"Phase 2","brief_title":"Irinotecan and Cisplatin in Treating Patients With Locally Advanced or Metastatic Penile Cancer","official_title":"Phase II Study of Irinotecan (CPT 11) and Cisplatin (CDDP) in Metastatic or Locally Advanced Penile Carcinoma","primary_completion_date":"2006-01-31","study_type":"Interventional","rec_status":"Completed","last_update":"2012-09-24","description":"RATIONALE: Drugs used in chemotherapy such as irinotecan and cisplatin use different ways to stop tumor cells from dividing so they stop growing or die. Combining irinotecan with cisplatin may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining irinotecan with cisplatin in treating patients who have locally advanced or metastatic penile cancer.","other_id":"EORTC-30992","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","maximum_age":75,"population":"","criteria":"\n        DISEASE CHARACTERISTICS:\r\n\r\n          -  Histologically confirmed penile squamous cell carcinoma\r\n\r\n               -  Locally advanced or metastatic disease\r\n\r\n                    -  T3, N1-2 OR T4, N3, M1\r\n\r\n          -  Measurable disease outside of any previously irradiated field\r\n\r\n          -  No clinical signs of brain metastases\r\n\r\n        PATIENT CHARACTERISTICS:\r\n\r\n        Age\r\n\r\n          -  75 and under\r\n\r\n        Performance status\r\n\r\n          -  WHO 0-2\r\n\r\n        Life expectancy\r\n\r\n          -  Not specified\r\n\r\n        Hematopoietic\r\n\r\n          -  Absolute neutrophil count at least 2,000/mm^3\r\n\r\n          -  Platelet count at least 100,000/mm^3\r\n\r\n        Hepatic\r\n\r\n          -  Bilirubin no greater than 1.5 times upper limit of normal (ULN)\r\n\r\n          -  Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN in the presence of\r\n             liver metastases)\r\n\r\n          -  Transaminases no greater than 2.5 times ULN (5 times ULN in the presence of liver\r\n             metastases)\r\n\r\n        Renal\r\n\r\n          -  Glomerular filtration rate at least 60 mL/min\r\n\r\n        Gastrointestinal\r\n\r\n          -  No chronic diarrhea\r\n\r\n          -  No unresolved bowel obstruction\r\n\r\n          -  No chronic inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)\r\n\r\n        Other\r\n\r\n          -  No other prior or concurrent malignancy except adequately treated skin cancer\r\n\r\n          -  No psychological, familial, sociological, or geographical condition that would\r\n             preclude study compliance and follow-up\r\n\r\n        PRIOR CONCURRENT THERAPY:\r\n\r\n        Biologic therapy\r\n\r\n          -  Not specified\r\n\r\n        Chemotherapy\r\n\r\n          -  No prior chemotherapy\r\n\r\n        Endocrine therapy\r\n\r\n          -  Not specified\r\n\r\n        Radiotherapy\r\n\r\n          -  See Disease Characteristics\r\n\r\n          -  More than 4 weeks since prior radiotherapy\r\n\r\n          -  No concurrent radiotherapy for pain control\r\n\r\n        Surgery\r\n\r\n          -  Not specified\r\n\r\n        Other\r\n\r\n          -  No other concurrent experimental or anticancer therapy\r\n      ","sponsor":"European Organisation for Research and Treatment of Cancer - EORTC","sponsor_type":"Other","conditions":"Penile Cancer","interventions":[{"intervention_type":"Procedure","name":"Procedure: neoadjuvant therapy"},{"intervention_type":"Drug","name":"Drug: cisplatin"},{"intervention_type":"Drug","name":"Drug: irinotecan hydrochloride"}],"outcomes":[{"outcome_type":"primary","measure":"Objective response rate measured by RECIST at 8 weeks after completion of study treatment"},{"outcome_type":"secondary","measure":"Duration of response as measured by Kaplan-Meier every 8 weeks until progression, and then every 3 months thereafter"},{"outcome_type":"secondary","measure":"Toxicity as measured by NCI-CTC v2.0 every 8 weeks until progression"}]}
{"nct_id":"NCT00631800","start_date":"2003-05-31","phase":"Phase 2","enrollment":88,"brief_title":"Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity Study in VLBW Neonates of BSYX-A110","official_title":"Phase II Randomized, Double Blind, Placebo Controlled, Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity Study in VLBW Neonates of BSYX-A110, for the Prevention of Staphylococcal Infection","primary_completion_date":"2004-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2004-11-30","last_update":"2008-03-10","description":"The purpose of this study is to evaluate the safety (including tolerability), pharmacokinetics, pharmacodynamics and clinical activity of BSYX-A110 administered in a 3-dose regimen on Study Days 0, 7, and 14.","other_id":"MAB-N003","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"All","maximum_age":120,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Patients must meet all of the following criteria at the time of first infusion (Day 0):\r\n\r\n          1. 48-120 hours of age, inclusive\r\n\r\n          2. Birth weight of 700-1300 grams\r\n\r\n          3. Inpatient in a Neonatal Intensive Care Unit\r\n\r\n          4. Written informed consent obtained from the parent(s) or legal guardian\r\n\r\n        Multiple gestations:\r\n\r\n          1. Siblings from multiple gestations may be enrolled if they each meet the entry criteria\r\n\r\n          2. No more than 4 subjects in any birth weight cohort may be siblings\r\n\r\n        Exclusion Criteria:\r\n\r\n        Patients may have none of the following at the first dose:\r\n\r\n          1. Survival not expected for at least 1 week after infusion\r\n\r\n          2. Clinically overt systemic infection, as determined by history, physical examination,\r\n             and positive culture from a normally sterile site. (Infuse only when infant clinically\r\n             stable and cultures negative for 48 hours. If being evaluated for sepsis, decision to\r\n             infuse may be deferred as allowed by protocol infusion window. Infusions outside of\r\n             protocol window must be approved by Sponsor.)\r\n\r\n          3. Severe congenital anomalies or genetic disorders that are likely to be fatal or that\r\n             may interfere with drug distribution or metabolism, as determined by history and/or\r\n             physical examination, and including but not limited to:\r\n\r\n             i. Trisomy 13 ii. Trisomy 18 iii. Hypoplastic Left Heart Syndrome iv. Omphalocele v.\r\n             Gastroschesis vi. Holoprosencephaly\r\n\r\n          4. Known or suspected hepatic or renal insufficiency\r\n\r\n          5. Clinically uncontrolled seizures\r\n\r\n          6. Immunodeficiency other than due to prematurity\r\n\r\n          7. A history of standard immune globulin administration prior to first study drug\r\n             infusion (excluding Hepatitis B Immune Globulin, HBIG)\r\n\r\n          8. Any history, in the infant subject or its mother, of a hypersensitivity or severe\r\n             vasomotor reaction to immunoglobulin G, or blood products\r\n\r\n          9. Currently receiving, recently received, or planned to receive other investigational\r\n             agents that could interfere with conduct or results of this study; including\r\n             enrollment in another investigational study for a product under an IRB-approved\r\n             protocol\r\n\r\n         10. Expectation that the patient will not be able to be followed for the duration of the\r\n             study\r\n\r\n         11. Mother with serology positive for hepatitis B surface antigen\r\n      ","sponsor":"Biosynexus Incorporated","sponsor_type":"Industry","conditions":"Staphylococcal Sepsis","interventions":[{"intervention_type":"Drug","name":"Drug: Pagibaximab (formerly BSYX-A110)","description":"Pagibaximab at 60, 90 mg/kg intravenously at Days 0, 7, 14"}],"outcomes":[{"outcome_type":"primary","measure":"Safety and pharmacokinetics","time_frame":"0 - 56 days"},{"outcome_type":"secondary","measure":"Pharmacodynamics, sepsis/bloodstream infection","time_frame":"0 - 56 days"}]}
{"nct_id":"NCT00062660","start_date":"2003-05-31","brief_title":"Tipranavir in Patients With Progressive, Systemic HIV-1 Disease Who Have Failed or Are Intolerant to Currently Approved Treatments for HIV Infection","official_title":"An Open Label Safety Study to Evaluate the Safety of Tipranavir Plus Ritonavir When Used in Combination With Other Agents for the Treatment of Patients With HIV Infection Who Have Failed and/or Are Intolerant to Combination Antiretroviral Therapy and Have Limited Treatment Options","primary_completion_date":"2014-04-30","study_type":"Expanded Access","rec_status":"Approved for marketing","completion_date":"2014-04-30","last_update":"2016-11-30","description":"To provide early access to tipranavir and evaluate the safety and tolerance of tipranavir combined with low dose of ritonavir in patients with progressive, HIV-1 disease who have failed or are intolerant to currently approved treatments for HIV infection, who are unable to participate in another tipranavir controlled clinical trial and have an urgent need for anti-HIV treatment.","other_id":"1182.58","sampling_method":"","gender":"All","minimum_age":2,"population":"","criteria":"\n        Inclusion criteria:\r\n\r\n        Patients aho have a positive serology HIV antibody test confirmed by Western blot, p24\r\n        antigen assay, HIV-1 RNA or HIV culture and are highly pre-treated and virus resistant to\r\n        multiple protease inhibitors.\r\n      ","sponsor":"Boehringer Ingelheim","sponsor_type":"Industry","conditions":"HIV Infections","interventions":[{"intervention_type":"Drug","name":"Drug: Tipranavir","description":"Tipranavir 250 mg soft elastic capsules"}],"outcomes":{}}
{"nct_id":"NCT00063947","start_date":"2003-05-31","phase":"Phase 1","enrollment":28,"brief_title":"Erlotinib, Gemcitabine, and Radiation Therapy in Treating Patients With Locally Advanced Unresectable Pancreatic Cancer","official_title":"A Phase I Study of OSI-774 in Combination With Gemcitabine and Radiation in Locally Advanced, Non-Operable Pancreatic Cancer","primary_completion_date":"2009-02-28","study_type":"Interventional","rec_status":"Completed","last_update":"2013-06-04","description":"This phase I trial is studying the side effects and best dose of erlotinib when given together with gemcitabine and radiation therapy in treating patients with locally advanced unresectable pancreatic cancer. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining erlotinib with gemcitabine may make the tumor cells more sensitive to radiation therapy and may kill more tumor cells.","other_id":"NCI-2012-01439","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically or cytologically confirmed adenocarcinoma of the pancreas\r\n\r\n               -  Locally advanced, unresectable disease, defined by all of the following:\r\n\r\n                    -  Obvious encasement of the celiac, hepatic, or superior mesenteric artery\r\n\r\n                    -  Encasement of the portal or superior mesenteric vein not amenable to\r\n                       surgical resection\r\n\r\n                    -  Extrapancreatic extension with or without regional lymph node involvement\r\n\r\n                    -  No evidence of distant metastatic disease by staging laparoscopy*\r\n\r\n               -  Locally recurrent disease after prior curative surgery allowed provided the\r\n                  following are true:\r\n\r\n                    -  No prior chemotherapy or radiotherapy\r\n\r\n                    -  No evidence of distant metastatic disease by staging laparoscopy*\r\n\r\n          -  No islet cell pancreatic cancer or lymphoma or sarcoma of the pancreas\r\n\r\n          -  Measurable or evaluable disease\r\n\r\n               -  Primary pancreatic tumor is considered evaluable and not measurable disease\r\n\r\n               -  Lymph node mass considered measurable disease\r\n\r\n          -  No known brain metastases\r\n\r\n          -  Performance status - ECOG 0-2\r\n\r\n          -  More than 12 weeks\r\n\r\n          -  WBC  3,000/mm^3\r\n\r\n          -  Absolute neutrophil count  1,500/mm^3\r\n\r\n          -  Platelet count  100,000/mm^3\r\n\r\n          -  Bilirubin  1.5 mg/dL\r\n\r\n          -  AST and ALT  2.5 times upper limit of normal\r\n\r\n          -  Creatinine  2.0 mg/dL\r\n\r\n          -  Creatinine clearance  60 mL/min\r\n\r\n          -  No symptomatic congestive heart failure\r\n\r\n          -  No unstable angina pectoris\r\n\r\n          -  No cardiac arrhythmia\r\n\r\n          -  No abnormalities of the cornea based on history (e.g., dry eye syndrome or Sjgren's\r\n             syndrome)\r\n\r\n          -  No congenital abnormality (e.g., Fuch's dystrophy)\r\n\r\n          -  No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)\r\n\r\n          -  No abnormal corneal sensitivity test (Schirmer test or similar tear production test)\r\n\r\n          -  No Crohn's disease or inflammatory bowel disease that would preclude undergoing\r\n             external beam radiotherapy\r\n\r\n          -  Able to tolerate oral medication\r\n\r\n          -  No requirement for IV alimentation\r\n\r\n          -  Not pregnant or nursing\r\n\r\n          -  Negative pregnancy test\r\n\r\n          -  Fertile patients must use effective contraception\r\n\r\n          -  No ongoing or active infection\r\n\r\n          -  No other concurrent uncontrolled illness\r\n\r\n          -  No psychiatric illness or social situation that would preclude study compliance\r\n\r\n          -  See Disease Characteristics\r\n\r\n          -  No prior gemcitabine\r\n\r\n          -  See Disease Characteristics\r\n\r\n          -  See Disease Characteristics\r\n\r\n          -  No prior epidermal growth factor receptor-targeting therapy\r\n\r\n          -  No prior therapy for pancreatic cancer (except surgery)\r\n\r\n          -  No concurrent commercial or other investigational agents or therapies intended to\r\n             treat the malignancy\r\n\r\n          -  No concurrent combination antiretroviral therapy for HIV-positive patients\r\n      ","sponsor":"National Cancer Institute (NCI)","sponsor_type":"NIH","conditions":"Adenocarcinoma of the Pancreas|Recurrent Pancreatic Cancer|Stage II Pancreatic Cancer|Stage III Pancreatic Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: erlotinib hydrochloride","description":"Given orally"},{"intervention_type":"Drug","name":"Drug: gemcitabine hydrochloride","description":"Given IV"},{"intervention_type":"Radiation","name":"Radiation: radiation therapy","description":"Undergo radiotherapy"},{"intervention_type":"Other","name":"Other: laboratory biomarker analysis","description":"Correlative studies"}],"outcomes":[{"outcome_type":"primary","measure":"Maximum-tolerated dose (MTD) of erlotinib hydrochloride based on the incidence of dose-limiting toxicity (DLT) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0","time_frame":"7.5 weeks"},{"outcome_type":"secondary","measure":"Toxicity as assessed by CTCAE version 3.0","time_frame":"7.5 weeks"},{"outcome_type":"secondary","measure":"Response rate according to Response Evaluation Criteria in Solid Tumors (RECIST)","time_frame":"Up to 6 years","description":"Kaplan-Meier methods will be utilized to estimate the response duration."},{"outcome_type":"secondary","measure":"Progression-free survival as assessed by RECIST","time_frame":"From the time of study enrollment until progression of disease is documented, assessed up to 6 years","description":"Kaplan-Meier methods will be utilized to estimate the progression-free survival."},{"outcome_type":"secondary","measure":"Overall survival","time_frame":"From the time of study enrollment until the date of death, assessed up to 6 years"}]}
{"nct_id":"NCT00046904","start_date":"2003-05-31","phase":"Phase 3","brief_title":"Etanercept in Treating Cancer-Related Cachexia and Anorexia in Patients With Advanced Cancer","official_title":"Phase III Placebo-Controlled, Randomized, Double-Blind Comparison Of Etanercept (Enbrel) Versus Placebo For The Treatment Of Cancer-Associated Weight Loss And Anorexia","primary_completion_date":"2007-09-30","study_type":"Interventional","rec_status":"Completed","last_update":"2011-05-05","description":"RATIONALE: Etanercept is a substance that is being studied as a treatment for cachexia (weight loss) and anorexia (lack of appetite) in patients who have cancer. It is not yet known whether etanercept is effective in improving cancer-related cachexia and anorexia. PURPOSE: Randomized phase III trial to determine the effectiveness of etanercept in treating cancer-related cachexia and anorexia in patients who have advanced cancer.","other_id":"CDR0000257027","allocation":"Randomized","primary_purpose":"Supportive Care","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        DISEASE CHARACTERISTICS:\r\n\r\n          -  Histologically or cytologically confirmed malignancy except brain cancer\r\n\r\n               -  If the patient has multiple primaries or an unknown primary, the currently active\r\n                  cancer cannot be brain cancer\r\n\r\n          -  Disease considered incurable with available therapies\r\n\r\n          -  No clinical evidence of ascites\r\n\r\n          -  Weight loss of at least 5 pounds (2.3 kg) within the past 2 months (excluding\r\n             perioperative weight loss) and/or estimated caloric intake of less than 20 cal/kg\r\n             daily\r\n\r\n          -  Weight gain determined by physician to be beneficial\r\n\r\n          -  Patient perceives weight loss as a problem\r\n\r\n        PATIENT CHARACTERISTICS:\r\n\r\n        Age\r\n\r\n          -  18 and over\r\n\r\n        Performance status\r\n\r\n          -  ECOG 0-2\r\n\r\n        Life expectancy\r\n\r\n          -  More than 3 months\r\n\r\n        Hematopoietic\r\n\r\n          -  Not specified\r\n\r\n        Hepatic\r\n\r\n          -  Not specified\r\n\r\n        Renal\r\n\r\n          -  Not specified\r\n\r\n        Cardiovascular\r\n\r\n          -  No poorly controlled congestive heart failure\r\n\r\n          -  No poorly controlled hypertension\r\n\r\n          -  No pacemaker, implanted defibrillator, stents, or metal suture material in the heart\r\n             or great vessels (for patients participating in the BIA translational portion of the\r\n             study)\r\n\r\n        Gastrointestinal\r\n\r\n          -  No known mechanical obstruction of the alimentary tract\r\n\r\n          -  No malabsorption\r\n\r\n          -  No intractable vomiting (more than 5 episodes/week)\r\n\r\n          -  Not concurrently receiving tube feedings or parenteral nutrition\r\n\r\n        Other\r\n\r\n          -  Able to reliably administer subcutaneous medication twice weekly\r\n\r\n          -  Alert and mentally competent\r\n\r\n          -  Not pregnant or nursing\r\n\r\n          -  Negative pregnancy test\r\n\r\n          -  Fertile patients must use effective contraception\r\n\r\n        PRIOR CONCURRENT THERAPY:\r\n\r\n        Biologic therapy\r\n\r\n          -  More than 1 month since prior infliximab\r\n\r\n          -  No concurrent live vaccination\r\n\r\n        Chemotherapy\r\n\r\n          -  Concurrent chemotherapy allowed\r\n\r\n        Endocrine therapy\r\n\r\n          -  At least 1 month since prior adrenal steroids\r\n\r\n          -  No concurrent adrenal steroids (inhalant, topical, or optical steroids allowed)\r\n\r\n               -  Concurrent short-term dexamethasone for chemotherapy-induced emesis is allowed\r\n\r\n        Radiotherapy\r\n\r\n          -  Concurrent radiotherapy allowed\r\n\r\n        Surgery\r\n\r\n          -  Not specified\r\n\r\n        Other\r\n\r\n          -  More than 1 month since prior etanercept\r\n\r\n          -  No concurrent evaluation with another device that injects an electrical current into\r\n             the body (for patients participating in the bioelectrical impendance analysis [BIA]\r\n             translational portion of the study)\r\n      ","sponsor":"Mayo Clinic","sponsor_type":"Other","conditions":"Anorexia|Cachexia|Unspecified Adult Solid Tumor, Protocol Specific","interventions":[{"intervention_type":"Biological","name":"Biological: etanercept"}],"outcomes":[{"outcome_type":"primary","measure":"Comparison of weight gain and rate of weight change"},{"outcome_type":"secondary","measure":"Differences in appetite"},{"outcome_type":"secondary","measure":"Overall survival"},{"outcome_type":"secondary","measure":"Incidence of treatment-related toxicity"},{"outcome_type":"secondary","measure":"Comparison of quality of life (QOL) as assessed by the QOL UNISCALE and the Functional Assessment of Cancer Therapy-Anorexia/cachexia (FACT-An) scale at baseline, weekly for one month, and then monthly during study treatment"}]}
{"nct_id":"NCT00114595","start_date":"2003-04-30","phase":"Phase 4","enrollment":84,"brief_title":"Ethyl-Eicosapentaenoic Acid and Tardive Dyskinesia","official_title":"A Double-Blind, Randomised, Parallel-Group Comparison of Ethyl-Eicosapentaenoic Acid (Ethyl-EPA) Versus Placebo as Add-on Medication in Patients With Established Tardive Dyskinesia","study_type":"Interventional","rec_status":"Completed","completion_date":"2005-03-31","last_update":"2005-06-24","description":"Tardive dyskinesia is a common complication of conventional antipsychotic treatment in subjects with schizophrenia. This study investigates whether the addition of the omega-3 fatty acid, ethyl-eicosapentaenoic acid (EPA) to usual treatment improves movement disorder in 84 schizophrenia subjects with established tardive dyskinesia. The initial double-blinded, randomised trial duration is 12 weeks, followed by further 46 weeks of open-label treatment.","other_id":"2002/M044","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Male or female aged 18 to 60 yrs\r\n\r\n          -  Meeting Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV)\r\n             criteria for TD.\r\n\r\n          -  Meeting DSM-IV criteria for schizophrenia or schizo-affective disorder.\r\n\r\n          -  CGI severity of TD score >3.\r\n\r\n          -  Patients from whom informed, written consent is obtained.\r\n\r\n          -  Patients who have been on a fixed dose of antipsychotic medication for at least 6\r\n             weeks prior to trial entry.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Significant neurological disorder other than TD\r\n\r\n          -  Substance abuse\r\n\r\n          -  Significant other medical illness\r\n\r\n          -  Psychiatric disorder not stabilised\r\n\r\n          -  Patients currently receiving clozapine\r\n\r\n          -  Pregnancy or lactation\r\n      ","sponsor":"University of Stellenbosch","sponsor_type":"Other","conditions":"Dyskinesia|Schizophrenia","interventions":[{"intervention_type":"Drug","name":"Drug: eicosapentaenoic acid"}],"outcomes":[{"outcome_type":"primary","measure":"Change in Extrapyramidal Symptom Rating Scale (ESRS) dyskinesia score from baseline to week 12."},{"outcome_type":"secondary","measure":"Change in ESRS for parkinsonism, dystonia, akathisia, and total scores from baseline to week 12"},{"outcome_type":"secondary","measure":"The proportion of subjects in each group who achieve a 30% reduction in ESRS total scores at week 12"},{"outcome_type":"secondary","measure":"Time to remission (defined as a 30% reduction in ESRS total scores)"},{"outcome_type":"secondary","measure":"The proportion of patients achieving a CGI Severity of TD score of < 3 at 12 weeks"},{"outcome_type":"secondary","measure":"Change in Positive and Negative Syndrome Scale (PANSS) total, positive, negative and general psychopathology scores from baseline to week 12"}]}
{"nct_id":"NCT00207441","start_date":"2003-04-30","phase":"N/A","enrollment":416,"brief_title":"Comparing ASHC and CDSMP Outcomes In Arthritis","official_title":"Comparing ASHC and CDSMP Outcomes In Arthritis","primary_completion_date":"2004-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2006-08-31","last_update":"2011-03-24","description":"The arthritis-specific Arthritis Self Help Course (ASHC) and the more generic Chronic Disease Self Management Program (CDSMP) teach generalizable skills for managing arthritis and other chronic diseases. In some locations it may be more feasible to combine efforts and offer the generic course rather than the arthritis-specific program. However anecdotal evidence has questioned whether people with arthritis obtain as much benefit from the more generic course as they do the arthritis-specific course. The primary purpose of this research studies is to compare health outcomes among people with arthritis who participate in either ASHC or the CDSMP. The North Carolina project is focusing primarily on African Americans from 6 rural counties in North Carolina. The results of this research will be used to guide Arthritis program recommendations on the use of ASHC and CDSMP to improve the quality of life for people with arthritis.","other_id":"CDC-NCCDPHP-S2233-22/33","allocation":"Randomized","intervention_model":"Parallel Assignment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        African american adults with arthritis Caucasian adults with arthritis\r\n\r\n        Exclusion Criteria:\r\n\r\n        -\r\n      ","sponsor":"Centers for Disease Control and Prevention","sponsor_type":"U.S. Fed","conditions":"Arthritis","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Arthritis Self management program"},{"intervention_type":"Behavioral","name":"Behavioral: Chronic Disease Self Management Program"}],"outcomes":[{"outcome_type":"secondary","measure":"Self efficacy for arthritis management, measured at 4 and 12 months","time_frame":"4 months, 12 months"},{"outcome_type":"primary","measure":"Health related quality of life, measured at 4 and 12 months,","time_frame":"4 months, 12 months"},{"outcome_type":"primary","measure":"Health care utilization measured at 4 and 12 months","time_frame":"4 months, 12 months"},{"outcome_type":"secondary","measure":"Self management behaviors measured at 4 and 12 months","time_frame":"4 months, 12 months"}]}
{"nct_id":"NCT00871455","start_date":"2003-04-30","phase":"N/A","enrollment":20,"brief_title":"Effect of Low-Dose Baclofen Administration on the GH-IGF1 Axis Study","official_title":"Effect of Low-Dose Baclofen Administration on the GH-IGF1 Axis Study","primary_completion_date":"2007-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-12-31","last_update":"2012-04-02","description":"Insulin-like growth factor I (IGF-I) is used as a measure of the body's ability to produce growth hormone. Growth hormone is important for muscle tissue as well as many other tissues in the body. Growth hormone (GH) and IGF-I have been shown to be reduced in many persons with SCI. Baclofen is a FDA approved drug that is used to treat spasticity. Persons receiving long-term baclofen therapy have been demonstrated to have increased growth hormone and IGF-I levels. IGF-I levels will be determined before and after treatment with baclofen. In this study, the investigators will determine the minimum dose of baclofen at which improvements in GH and IGF-1 levels occur.","other_id":"B4162C-7","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients with chronic SCI (injury greater than 6 months) who have been screened and\r\n             found to have depressed plasma IGF-1 levels and who are not taking baclofen.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Acute illness of any etiology,\r\n\r\n          -  Patients with chronic renal, liver, lung, or cardiac disease,\r\n\r\n          -  Patients receiving any of the following medications: narcotics, or L-DOPA, and\r\n\r\n          -  Alcoholics.\r\n      ","sponsor":"US Department of Veterans Affairs","sponsor_type":"U.S. Fed","conditions":"Spinal Cord Injury","interventions":[{"intervention_type":"Drug","name":"Drug: Baclofen","description":"Subjects will receive 20 mg baclofen for 8 weeks, followed by 40 mg baclofen for 8 weeks."}],"outcomes":[{"outcome_type":"primary","measure":"Determine the threshold dose 20 or 40 mg/d of baclofen and the dose-response curve of the medication for its effect to raise plasma IGF-1 levels","time_frame":"20-week (5 months) in which subjects are asked to report for 12 visits after starting baclofen therapy"},{"outcome_type":"secondary","measure":"Assessment of the adverse side effects, if any, of low dose baclofen therapy","time_frame":"20-week (5 months) in which subjects are asked to report for 12 visits after starting baclofen therapy"}]}
{"nct_id":"NCT00057239","start_date":"2003-03-31","phase":"Phase 2","enrollment":546,"brief_title":"An 8 Week Depression Study In Adults Diagnosed With Major Depressive Disorder","official_title":"A Multi-Center, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Evaluating the Efficacy, Safety and Tolerability of Two Doses (20mg and 60mg) of a Once-Daily Oral Formulation of GW353162 in Subjects With Major Depressive Disorder for a Treatment Period of Eight Weeks","primary_completion_date":"2004-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2004-05-31","last_update":"2010-10-04","description":"A Placebo Controlled Study Evaluating Efficacy, Safety and Tolerability of Radafaxine in Patients with Major Depressive Disorder (MDD)","other_id":"OHB20001","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":64,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosis of Major Depressive Disorder (MDD)\r\n\r\n          -  Duration of current depressive episode 12 weeks - 24 months\r\n\r\n          -  Patients can read and write at a level sufficient to provide a signed consent\r\n\r\n          -  If female, patients must be practicing an acceptable method of birth control\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients have other psychiatric disorders that would affect patient's response to\r\n             treatment\r\n\r\n          -  Patients have not responded to two or more adequate courses of antidepressant therapy\r\n\r\n          -  Patients cannot be currently abusing illicit drugs or alcohol\r\n\r\n          -  Patients are not currently receiving psychotherapy\r\n\r\n          -  Patients have received electroconvulsive therapy within 6 months prior to screening\r\n\r\n          -  Patients are pregnant or lactating\r\n      ","sponsor":"GlaxoSmithKline","sponsor_type":"Industry","conditions":"Major Depressive Disorder (MDD)","interventions":[{"intervention_type":"Drug","name":"Drug: Radafaxine"}],"outcomes":[{"outcome_type":"primary","measure":"Change in the Montgomery-Asberg Depression Rating Scale (MADRS) score after 8 weeks of treatment","time_frame":"8 Weeks"},{"outcome_type":"secondary","measure":"Change in the MADRS score at other timepoints; change in Clinical Global Impression; percentage of remitters and responders based on the MADRS; change in disability, motivation, energy and pain;incidence of adverse events over course of study.","time_frame":"8 Weeks"}]}
{"nct_id":"NCT00500578","start_date":"2003-02-28","phase":"Phase 4","enrollment":51,"brief_title":"Intermittent Use of Aerosolized Ribavirin for Treatment of RSV","official_title":"A Randomized Study Evaluating Two Different Schedules of Aerosolized Ribavirin For Treatment of RSV Upper Respiratory Infections in Patients With Hematological Malignancies","primary_completion_date":"2009-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-01-31","last_update":"2012-08-01","description":"Primary Objectives: 1. To determine whether aerosolized ribavirin is effective when given at an intermittent dose over 3 hours every 8 hours for therapy of RSV upper respiratory tract infection (URI) and whether it can prevent progression to pneumonia. 2. To determine the effect of this regimen on persistence of viral shedding.","other_id":"ID03-0010","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":5,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Patients with these underlying malignancies will be eligible for this study:\r\n             Autologous BMT patients, Allogeneic BMT patients, and patients with hematological\r\n             malignancy.\r\n\r\n          2. Patients must be at least 5 years of age.\r\n\r\n          3. Only patients with infection limited to the URT will be eligible for entry on study\r\n\r\n          4. Patients will be eligible for entry on study if a nasopharyngeal wash or throat swab\r\n             specimen is positive by rapid RSV antigen testing or by a positive culture for RSV.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients with evidence of RSV LRTI as documented by a positive rapid RSV antigen\r\n             testing or by a positive culture for RSV from a nasopharyngeal wash or throat swab AND\r\n             new infiltrates on chest radiograph and/or abnormal blood gas determination\r\n\r\n          2. Patients with hypersensitivity to ribavirin or its components\r\n\r\n          3. Pregnant women. Participants must practice birth control during the study if they are\r\n             sexually active. If the participant is pregnant, she may not be enrolled on this\r\n             study. Mothers should refrain from breast-feeding during the study to avoid injury to\r\n             their children.\r\n\r\n          4. Patients with positive RSV by rapid testing or culture in bronchoalveolar lavage\r\n             regardless of the chest radiographic results.\r\n      ","sponsor":"M.D. Anderson Cancer Center","sponsor_type":"Other","conditions":"Hematological Malignancies","interventions":[{"intervention_type":"Drug","name":"Drug: Ribavirin","description":"Arm 1 = 6 Grams Over 18 hours Every 24 Hours"},{"intervention_type":"Drug","name":"Drug: Ribavirin","description":"Arm 2 = 2 Grams Over 3 Hours Every 8 Hours."}],"outcomes":[{"outcome_type":"primary","measure":"Occurrences of Pneumonia","time_frame":"6 Years","description":"Treatment failure defined as progression to pneumonia within 7 days of initial treatment with aerosolized ribavirin. Patients considered as a failure or to have an unfavorable response if there develop signs and symptoms of pneumonia during therapy either evidenced by chest-xray or clinically, meaning they did reach the primary endpoint."}]}
{"nct_id":"NCT00116623","start_date":"2003-02-28","phase":"Phase 4","brief_title":"Magnesium Sulfate Versus Indomethacin for Preterm Labor","primary_completion_date":"2006-02-28","study_type":"Interventional","rec_status":"Terminated","completion_date":"2006-02-28","last_update":"2016-08-15","description":"The purpose of this study is to investigate the efficacy of Indomethacin compared to Magnesium Sulfate (MgSO4) in reducing neonatal morbidity through a prospective double blind randomized clinical trial. The specific aim of the project is to test the hypothesis that Indomethacin, compared to MgSO4, will decrease the proportion of neonates diagnosed with major complications or death.","other_id":"704914","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"Female","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Initial episode of preterm labor for enrollment\r\n\r\n          -  The diagnosis of preterm labor\r\n\r\n          -  Gestational age between 24 and 32 weeks\r\n\r\n          -  Singleton or twin gestation\r\n\r\n          -  The ability to understand the requirements of the study\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Cervical dilation >5 cms\r\n\r\n          -  Suspected chorioamnionitis\r\n\r\n          -  Fetal distress\r\n\r\n          -  Vaginal bleeding\r\n\r\n          -  Severe pre-eclampsia\r\n\r\n          -  History of gastrointestinal bleeding\r\n\r\n          -  Abnormal renal function\r\n\r\n          -  Suspicion of fetal malformation by ultrasound\r\n\r\n          -  Known allergy to, or intolerance of, Magnesium sulfate and/or Indomethacin\r\n\r\n          -  Documented rupture of amniotic membranes\r\n\r\n          -  Multiple gestations of triplets or more.\r\n      ","sponsor":"University of Pennsylvania","sponsor_type":"Other","conditions":"Labor, Premature","interventions":[{"intervention_type":"Drug","name":"Drug: Indomethacin"},{"intervention_type":"Drug","name":"Drug: Magnesium sulfate"}],"outcomes":{}}
{"nct_id":"NCT00502411","start_date":"2003-01-31","phase":"Phase 1","enrollment":4,"brief_title":"Post-Operative Chemoradiation for Extremity & Trunk Soft Tissue Sarcoma","official_title":"A Phase I Study of Post-Operative Concurrent Chemoradiation for Extremity and Trunk Soft Tissue Sarcoma","primary_completion_date":"2015-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-04-30","last_update":"2015-11-18","description":"The goal of this clinical research study is to learn if the combination of radiation therapy plus low dose doxorubicin chemotherapy given after surgery is effective in the treatment of sarcoma. The safety of this treatment will also be studied.","other_id":"ID02-336","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. All patients with cytological or histological proof of large (> 5 cm), completely\r\n             resected soft tissue sarcoma of the extremity or trunk (AJCC Stage IB, IIA, IIC, and\r\n             III) will be eligible. Patients with stage IV sarcoma who are considered for primary\r\n             tumor treatment with surgery and postoperative radiation are also eligible.\r\n\r\n          2. Patients who have undergone pre-referral surgical resection or excisional biopsy with\r\n             no measurable residual disease on appropriate radiological imaging will be eligible.\r\n             The adequacy of the surgical resection will be evaluated at MDACC and re-excision will\r\n             be performed as necessary. Negative surgical resection margins are desirable; positive\r\n             margins, however, are allowable if re-excision would result in functional deficit.\r\n\r\n          3. Patients may have received prior doxorubicin-based systemic chemotherapy up to a total\r\n             doxorubicin dose of 450 mg/m2. Inclusion of patients with a prior history of\r\n             malignancy will be at the discretion of the Study Chairman.\r\n\r\n          4. Patients must have a Karnofsky P.S. of > 70 or a Zubrod P.S. of 0 or 1.\r\n\r\n          5. Absolute neutrophil count must be > 1,500 cells/mm; platelet count > 100,000\r\n             platelets/ml; serum creatinine < 1.8 mg/dl, serum glutamate oxaloacetate transaminase\r\n             (SGOT)/serum glutamate pyruvate transaminase (SGPT) < 3 x normal, total bilirubin <\r\n             1.5 mg/dl. For patients with cumulative doxorubicin 400 - 450 mg/m2, EF > 50%.\r\n\r\n          6. EKG (within 6 weeks of the planned start of treatment).\r\n\r\n          7. Echocardiogram or multiple gated acquisition scan (MUGA) (if prior doxorubicin\r\n             treatment or history of either myocardial infarction or congestive heart failure).\r\n\r\n          8. Patients must have no uncontrolled co-existing medical conditions.\r\n\r\n          9. Women of childbearing potential must not be pregnant or breast feeding and must\r\n             practice adequate contraception.\r\n\r\n         10. All patients must sign an informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n        1) Patients with a history of prior radiotherapy in the area of the primary tumor or those\r\n        in whom the anticipated radiation field would include the perineum, scrotum, or vaginal\r\n        introitus will not be eligible.\r\n      ","sponsor":"M.D. Anderson Cancer Center","sponsor_type":"Other","conditions":"Soft Tissue Sarcoma","interventions":[{"intervention_type":"Drug","name":"Drug: Doxorubicin","description":"17.5 mg/m^2 IV bolus infusion, followed by continuous IV infusion on days 1-4."},{"intervention_type":"Radiation","name":"Radiation: Radiation Therapy","description":"Radiation treatments 5 days a week for 6 - 6 1/2 weeks. 60 Gy in 6 weeks (negative resection margin) to 66 Gy in 6.5 weeks (positive resection margin)."}],"outcomes":[{"outcome_type":"primary","measure":"Toxicity of Radiation Therapy Plus Low Dose Doxorubicin in Participants with Extremity and Trunk Sarcoma","time_frame":"6 weeks after the start of Doxorubicin","description":"Toxicity defined by acute local toxicity to skin and subcutaneous tissues and delayed wound healing. Toxicity defined as (1) grade 3 or 4 myelosuppression with fever or (2) grade 3 or 4 desquamation, or (3) both (1) and (2), scored within 6 weeks from the start of doxorubicin treatment."}]}
{"nct_id":"NCT00357149","start_date":"2003-01-31","phase":"Phase 2","enrollment":101,"brief_title":"Neoadjuvant Docetaxel Plus Cisplatin and 5-fluorouracil (TPF) Followed by Concomitant Chemoradiotherapy and Chemoradiotherapy Alone in Locally Advanced Squamous Cell Carcinoma of the Head and Neck Patients (SCCHNS)","official_title":"Randomized Phase II Trial of Neoadjuvant Docetaxel Plus Cisplatin and 5-fluorouracil Followed by Concomitant Chemoradiotherapy and Chemoradiotherapy Alone in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck.","primary_completion_date":"2008-02-29","study_type":"Interventional","rec_status":"Completed","last_update":"2009-12-07","description":"To evaluate the rate of clinical complete response 6-8 weeks after treatment with docetaxel plus cisplatin and 5-fluorouracil followed by chemoradiotherapy and after chemoradiotherapy alone in patients with locally advanced squamous cell carcinoma of the head and neck.","other_id":"XRP6976F_2501","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion criteria:\r\n\r\n          -  Histologically or cytologically proven squamous cell carcinoma of the head and neck.\r\n\r\n          -  Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx. Although they are\r\n             admittedly of squamous cell types, the following tumors will be excluded because of\r\n             theY responsiveness to chemotherapy: tumors of the nasal and paranasal cavities,\r\n             larynx and of the nasopharynx.\r\n\r\n          -  Stage III or IV disease without evidence of distant metastases verified by chest X Ray\r\n             and/or lung CT scan, abdominal ultrasound, or CT (liver function test abnormalities);\r\n             bone scan in case of local symptoms.\r\n\r\n          -  At least one measurable lesion.\r\n\r\n          -  Tumor considered inoperable after evaluation by a multidisciplinary team (i.e. a\r\n             surgeon, a medical oncologist and a radiation oncologist).\r\n\r\n          -  No previous chemotherapy or radiotherapy for any reason and no previous surgery for\r\n             squamous cell carcinoma of the head and neck patients (other than biopsy) are allowed\r\n             at time of study entry.\r\n\r\n          -  Karnofsky performance status  70.\r\n\r\n          -  No active alcohol addiction.\r\n\r\n          -  Adequate bone marrow, hepatic and renal functions\r\n\r\n          -  Patients must be available for treatment and follow-up.\r\n\r\n        Exclusion criteria\r\n\r\n          -  Pregnant or lactating women or women of childbearing potential not using adequate\r\n             contraception.\r\n\r\n          -  Previous or current malignancies at other sites, with the exception of adequately\r\n             treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the\r\n             skin, or other cancer curatively treated by surgery and with no evidence of disease\r\n             for at least 5 years.\r\n\r\n          -  Symptomatic peripheral neuropathy  grade 2\r\n\r\n          -  Symptomatic altered hearing  grade 2\r\n\r\n          -  Other serious illnesses or medical conditions including:a) Unstable cardiac disease\r\n             despite treatment, myocardial infarction within 6 months prior to study entry.b)\r\n             History of significant neurologic or psychiatric disorders including dementia or\r\n             seizures.c) Active uncontrolled infection.d) Active peptic ulcer.e) Hypercalcemia.f)\r\n             Chronic obstructive pulmonary disease requiring hospitalization during the year\r\n             preceding study entry\r\n\r\n          -  History of hypersensitivity reaction to polysorbate 80\r\n\r\n          -  Patients requiring intravenous alimentation.\r\n\r\n          -  Patients who experienced a weight loss of more than 20% of their body weight in the 3\r\n             months preceding study entry.\r\n\r\n          -  Concomitant treatment with any other anticancer therapy.\r\n\r\n          -  Participation in a therapeutic clinical trial within 30 days of study entry\r\n\r\n        The above information is not intended to contain all considerations relevant to a patient's\r\n        potential participation in a clinical trial.\r\n      ","sponsor":"Sanofi","sponsor_type":"Industry","conditions":"Head and Neck Neoplasms","interventions":[{"intervention_type":"Drug","name":"Drug: Docetaxel, cisplatin and 5-FU treatment followed by concomitant cisplatin, 5-FU and radiotherapy"},{"intervention_type":"Drug","name":"Drug: Concomitant cisplatin, 5-FU and radiotherapy"}],"outcomes":[{"outcome_type":"primary","measure":"Rate of radiologic Complete Response (CR) evaluated 6-8 weeks after the completion of treatment","time_frame":"from end of treatment until 6-8 weeks"},{"outcome_type":"secondary","measure":"Duration of response","time_frame":"from the date of first documented tumor response to the date of first documented tumor progression"},{"outcome_type":"secondary","measure":"Time to disease progression","time_frame":"From the date of the treatment start to the date of first documented progression of disease"},{"outcome_type":"secondary","measure":"Time to treatment failure","time_frame":"from the date of treatment start to the date of diagnosis of progression, withdrawal from study treatment for any reason, administration of other antitumor treatment, or death for any cause"},{"outcome_type":"secondary","measure":"Median length of overall survival","time_frame":"time interval from the date of treatment to the date of death"}]}
{"nct_id":"NCT00755651","start_date":"2003-01-31","phase":"N/A","enrollment":180,"brief_title":"Studies on the H Pipelle, a New Device for Endometrial Sampling at Hysteroscopy","official_title":"Studies on the H Pipelle, a New Device for Endometrial Sampling at Hysteroscopy","primary_completion_date":"2007-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-05-31","last_update":"2008-09-19","description":"The investigators have developed a novel instrument for taking endometrial biopsies at no touch (vaginoscopic) hysterectomy which avoids the need to instrument the vagina with speculums and tenaculums, and also avoids the possible need for cervical dilatation. The investigators wish to study the ease of use and efficacy of the new device compared with traditional techniques of endometrial sampling at hysteroscopy.","other_id":"REC 6056","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":20,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Indication to carry out diagnostic hysteroscopy\r\n\r\n          -  Agrees and is suitable for outpatient/office hysteroscopy\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Failed outpatient/office hysteroscopy\r\n      ","sponsor":"Royal Free Hampstead NHS Trust","sponsor_type":"Other","conditions":"Abnormal Uterine Bleeding","interventions":[{"intervention_type":"Procedure","name":"Procedure: Endometrial biopsy","description":"Endometrial biopsy taken on completion of office/outpatient diagnostic hysteroscopy"}],"outcomes":[{"outcome_type":"primary","measure":"Discomfort","time_frame":"End of procedure"},{"outcome_type":"secondary","measure":"Procedure time, biopsy adequacy","time_frame":"End of procedure"}]}
{"nct_id":"NCT00055952","start_date":"2003-01-31","phase":"Phase 2","brief_title":"Exatecan Mesylate in Treating Patients With Ewing's Sarcoma, Primitive Neuroectodermal Tumor, or Desmoplastic Small Round Cell Tumor","official_title":"A Phase II Study Of Intravenous DX-8951f (EXATECAN MESYLATE) Administered Daily For Five Days Every Three Weeks To Pediatric And Young Adult Patients With Ewing's Sarcoma (ES), Primitive Neuroectodermal Tumor (PNET), Or Desmoplastic Small Round Cell Tumor (DSRCT)","primary_completion_date":"2006-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2006-04-30","last_update":"2012-05-16","description":"RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of exatecan mesylate in treating patients who have relapsed or refractory Ewing's sarcoma or peripheral primitive neuroectodermal tumor or desmoplastic small round cell tumor.","other_id":"CDR0000271889","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","population":"","criteria":"\n        DISEASE CHARACTERISTICS:\r\n\r\n          -  One of the following histologically confirmed diagnoses:\r\n\r\n               -  Relapsed or refractory Ewing's sarcoma or primitive neuroectodermal tumor\r\n\r\n               -  Desmoplastic small round cell tumor\r\n\r\n          -  Measurable disease\r\n\r\n               -  The following are not considered measurable disease:\r\n\r\n                    -  Ascites\r\n\r\n                    -  Pleural effusion\r\n\r\n                    -  Lytic bone lesions\r\n\r\n          -  No symptomatic brain metastases\r\n\r\n        PATIENT CHARACTERISTICS:\r\n\r\n        Age\r\n\r\n          -  Any age\r\n\r\n        Performance status\r\n\r\n          -  ECOG 0-2 (over 10 years of age)\r\n\r\n          -  Lansky 60-100% (10 years of age and under)\r\n\r\n        Life expectancy\r\n\r\n          -  At least 12 weeks\r\n\r\n        Hematopoietic\r\n\r\n          -  Absolute neutrophil count at least 750/mm^3\r\n\r\n          -  Platelet count at least 75,000/mm^3\r\n\r\n          -  Hemoglobin at least 8.5 g/dL\r\n\r\n        Hepatic\r\n\r\n          -  Bilirubin no greater than 2.0 mg/dL\r\n\r\n          -  AST or ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver\r\n             metastases are present)\r\n\r\n          -  Albumin at least 2.8 g/dL\r\n\r\n        Renal\r\n\r\n          -  Creatinine less than 1.5 times ULN\r\n\r\n        Other\r\n\r\n          -  Not pregnant or nursing\r\n\r\n          -  Negative pregnancy test\r\n\r\n          -  Fertile patients must use effective contraception\r\n\r\n          -  No active serious infection\r\n\r\n          -  No other malignancy within the past 5 years except nonmelanoma skin cancer or\r\n             carcinoma in situ of the cervix\r\n\r\n          -  No overt psychosis or mental disability that would preclude informed consent\r\n\r\n          -  No other life-threatening illness within the past 6 months\r\n\r\n        PRIOR CONCURRENT THERAPY:\r\n\r\n        Biologic therapy\r\n\r\n          -  At least 3 months since prior autologous bone marrow or stem cell transplantation\r\n\r\n          -  No concurrent biologic therapy\r\n\r\n        Chemotherapy\r\n\r\n          -  Recovered from prior systemic chemotherapy\r\n\r\n          -  Prior topoisomerase I inhibitor therapy allowed\r\n\r\n          -  No other concurrent chemotherapy\r\n\r\n        Endocrine therapy\r\n\r\n          -  Not specified\r\n\r\n        Radiotherapy\r\n\r\n          -  More than 4 weeks since prior cranial, spinal, or whole pelvis radiotherapy\r\n\r\n          -  More than 4 weeks since prior radiotherapy to 25% of bone marrow reserve\r\n\r\n          -  No concurrent radiotherapy\r\n\r\n        Surgery\r\n\r\n          -  At least 4 weeks since prior major surgery and recovered\r\n\r\n          -  No concurrent surgery\r\n\r\n        Other\r\n\r\n          -  More than 28 days since prior investigational drugs (including analgesics or\r\n             antiemetics)\r\n\r\n          -  No more than 2 prior treatment regimens for this disease\r\n\r\n          -  No other investigational drugs during and for 28 days after study therapy\r\n\r\n          -  No other concurrent anticancer therapy\r\n\r\n          -  No concurrent grapefruit or grapefruit juice\r\n      ","sponsor":"Daiichi Sankyo, Inc.","sponsor_type":"Industry","conditions":"Sarcoma","interventions":[{"intervention_type":"Drug","name":"Drug: exatecan mesylate"}],"outcomes":{}}
{"nct_id":"NCT00679679","start_date":"2003-01-31","phase":"Phase 4","enrollment":30,"brief_title":"Metformin and Lifestyle Intervention in Women With Polycystic Ovary Syndrome","official_title":"Clinical Metabolic and Endocrine Parameters in Response to Metformin and Lifestyle Intervention in Women With Polycystic Ovary Syndrome: A Phase 4 Randomized, Double- Blind and Placebo Control Trial","primary_completion_date":"2005-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2005-12-31","last_update":"2008-05-19","description":"Polycystic ovary syndrome is a frequent cause of abnormal menses and infertility. It has also been related to cardiovascular disease. The objective of this trial is to evaluate the clinical and metabolic efficacy of metformin plus life style modifications in women with polycystic ovary syndrome compared with life style modifications and placebo","other_id":"Fux-1","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":35,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Women in reproductive age\r\n\r\n          -  With polycystic ovary syndrome defined by hyperandrogenism (elevated serum\r\n             testosterone concentrations), and oligomenorrhea (cycles of 35 days or longer), or\r\n             amenorrhea (no menses in the last 6 months) after negative screening pregnancy test\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnancy\r\n\r\n          -  Cushing' s syndrome\r\n\r\n          -  Late onset congenital adrenal hyperplasia\r\n\r\n          -  Androgen-secreting tumors\r\n\r\n          -  Uncontrolled thyroid disease\r\n\r\n          -  Hyperprolactinemia\r\n\r\n          -  Diabetes any\r\n\r\n          -  Cardiovascular diseases (Ischaemic heart disease, uncontrolled hypertension, heart\r\n             failure)\r\n\r\n          -  Acute or chronic infections at baseline\r\n\r\n          -  Renal disease\r\n\r\n          -  Liver disease\r\n\r\n          -  Had taken any medications for at least 3 months before enrolment in the study.\r\n      ","sponsor":"Hospital Privado de Cordoba, Argentina","sponsor_type":"Other","conditions":"Polycystic Ovary Syndrome","interventions":[{"intervention_type":"Drug","name":"Drug: Metformin","description":"Metformin 750 mg BID for 4 months"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Diet counseling and exercise"}],"outcomes":[{"outcome_type":"primary","measure":"Body mass index,Normalization of menses,Pregnancy,Hirsutism,Waist to hip ratio, Testosterone, Androstenedione, DHEAS,Progesterone, FSH, LH,Glucose, OGTT,Insulinemia,Total HDL and LDL Cholesterol, Triglycerides,Uric acid, Prostate specific antigen","time_frame":"4 months"}]}
{"nct_id":"NCT00353093","start_date":"2003-01-31","phase":"N/A","enrollment":2000,"brief_title":"The ERASMUS Study: Limited vs Extended US for DVT Diagnosis","official_title":"Limited Versus Extended Ultrasonography for the Diagnosis of Clinically Symptomatic Deep Vein Thrombosis of the Lower Extremities. A Randomized Study","study_type":"Interventional","rec_status":"Completed","completion_date":"2005-07-31","last_update":"2006-10-20","description":"Currently, patients with suspected deep vein thrombosis (DVT) of the lower extremities receive the ultrasound investigation of their deep vein system, either by limited ultrasonography (ultrasonography confined to the proximal veins, repeating the test after one week in patients with positive D-dimer) or by extended ultrasonography (ultrasonography extented to the entire deep vein system of the legs). No study has directly compared the two strategies to assess their accuracy and safety. We plan to compare the accuracy and safety of the two strategies in a prospective randomized study addressing more than 2000 consecutive outpatients presenting with the clinical suspicion of DVT.","other_id":"07/01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  outpatients with clinically suspected deep vein thrombosis of the lower extremities\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  history of previous venous thromboembolism\r\n\r\n          -  clinical suspicion of pulmonary embolism\r\n\r\n          -  life expectancy shorter than 3 months\r\n\r\n          -  therapeutic doses of unfractionated heparin, low molecular weight heparin or oral\r\n             anticoagulants for more than 48 hours\r\n\r\n          -  another indication for anticoagulant treatment\r\n\r\n          -  pregnancy\r\n\r\n          -  age less than 18 years\r\n\r\n          -  inaccessibility to follow-up\r\n\r\n          -  refused participation in the study\r\n      ","sponsor":"University of Padova","sponsor_type":"Other","conditions":"Deep Vein Thrombosis of the Lower Extremities","interventions":[{"intervention_type":"Procedure","name":"Procedure: Ultrasonography of the deep vein system of the legs"}],"outcomes":[{"outcome_type":"primary","measure":"To assess(1) the prevalence and location of venous thrombosis"},{"outcome_type":"primary","measure":"as shown by the initial diagnostic workup; (2) the rate of"},{"outcome_type":"primary","measure":"symptomatic venous thromboembolic events (including proximal"},{"outcome_type":"primary","measure":"vein thrombosis, isolated thrombosis of the tibial or peroneal"},{"outcome_type":"primary","measure":"veins in either leg, and pulmonary embolism) during three months"},{"outcome_type":"primary","measure":"of follow up in patients with an initially normal diagnostic workup."}]}
{"nct_id":"NCT01867099","start_date":"2002-12-31","enrollment":445,"brief_title":"Ten-year Outcomes After AF Ablation","official_title":"Long-term Outcome After Initially Successful Catheter Ablation of Atrial Fibrillation by Pulmonary Vein Isolation: a Ten-Year Cohort Study","primary_completion_date":"2012-12-31","study_type":"Observational [Patient Registry]","rec_status":"Completed","completion_date":"2012-12-31","last_update":"2014-12-16","description":"Ablation of atrial fibrillation (AF) using pulmonary vein isolation is employed when patients do not respond favorably to medical therapy. Successful procedures are accomplished in the majority of patients, but the outcome after many years of follow-up after ablation is unknown.","other_id":"Valley 12.0032","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":85,"population":"Patients who underwent PVI ablation for drug refractory AF over a 10 year period and were\r\n        free of AF for one year after last ablation procedure","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Prior AF ablation procedure\r\n\r\n          -  No AF for one year post ablation\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Geographic inaccessibility\r\n\r\n          -  Longstanding persistent AF\r\n\r\n          -  Recurrent AF within one year of ablation\r\n\r\n          -  Prior AF ablation\r\n      ","sponsor":"Valley Health System","sponsor_type":"Other","conditions":"Atrial Fibrillation","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Atrial fibrillation or flutter > 30 secs","time_frame":"More than one year after successful primary ablation or redo procedure within 6 mos"}]}
{"nct_id":"NCT00117624","start_date":"2002-12-31","phase":"Phase 3","brief_title":"A Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With a Non-Myeloid Malignancy","official_title":"A Randomized, Double-Blind, Study of Front-Loading Darbepoetin Alfa Compared With Standard Weekly Administration for the Treatment of Anemia in Subjects With a Non-Myeloid Malignancy and Receiving Multicycle Chemotherapy","study_type":"Interventional","rec_status":"Completed","completion_date":"2003-12-31","last_update":"2007-12-28","description":"The purpose of this study is to compare the efficacy of darbepoetin alfa administered using a front-loading approach with subjects receiving standard weekly dosing in the treatment of anemia in subjects with a non-myeloid malignancy and receiving multicycle chemotherapy.","other_id":"20020118","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria: - Non-myeloid malignancy - At least 12 additional weeks of cyclic\r\n        cytotoxic chemotherapy anticipated regardless of schedule - ECOG 0-2 - Cancer and/or\r\n        chemotherapy-associated anemia Exclusion Criteria: - Known history of seizure disorder -\r\n        Known primary hematologic disorder, which could cause anemia, other than a non-myeloid\r\n        malignancy - Unstable or uncontrolled disease/condition, related to or affecting cardiac\r\n        function - Clinically significant inflammatory disease - Inadequate renal and/or liver\r\n        function\r\n      ","sponsor":"Amgen","sponsor_type":"Industry","conditions":"Anemia","interventions":[{"intervention_type":"Drug","name":"Drug: darbepoetin alfa"}],"outcomes":[{"outcome_type":"primary","measure":"RBC transfusion during the treatment phase"},{"outcome_type":"secondary","measure":"The time to hemoglobin response during the treatment phase"},{"outcome_type":"secondary","measure":"The FACT-Fatigue score profile over time"},{"outcome_type":"secondary","measure":"The change in hemoglobin"},{"outcome_type":"secondary","measure":"Incidence and severity of adverse events"}]}
{"nct_id":"NCT00087880","start_date":"2002-12-31","phase":"Phase 2","enrollment":407,"brief_title":"Maintaining Abstinence in Chronic Cigarette Smokers - 1","official_title":"Maintaining Abstinence in Chronic Cigarette Smokers","primary_completion_date":"2005-01-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2009-09-30","last_update":"2017-01-12","description":"The purpose of this study is to evaluate the extended pharmacological and psychological treatment for chronic cigarette smokers.","other_id":"NIDA-15732-1","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Subjects (N=400) will be men and women (50%) over the age of 18 who smoke at least 10\r\n        cigarettes per day and answers yes to the question \"Do you smoke within 30 minutes of\r\n        arising?\"\r\n\r\n        Inclusion Criteria:\r\n\r\n        -Subjects are age 18 and over, currently smoking 10 or more cigarettes per day, and report\r\n        a smoking history of at least 5 years in response to the question \"How long have you been a\r\n        regular smoker?\"\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of seizure or head injury resulting in unconsciousness\r\n\r\n          -  Any condition that might predispose to seizures (brain tumor or stroke)\r\n\r\n          -  A current or history of anorexia nervosa or bulimia\r\n\r\n          -  Any disease acutely life-threatening or so severe that the patient is judged unable to\r\n             comply with the protocol\r\n\r\n          -  Use of a protease inhibitor of MAO inhibitor within the last two week\r\n\r\n          -  Current use of psychiatric drugs that would interfere with interpretation of study\r\n             results, including antidepressants\r\n\r\n          -  Treatment for alcohol dependence during the last year, or evidence of alcohol abuse so\r\n             severe that the patient is judged potentially unable to comply with the protocol\r\n\r\n          -  Patients who know they are leaving the Bay Area within the study period and\r\n             non-English speakers will be excluded\r\n\r\n          -  Suicidal or homicidal ideation\r\n\r\n          -  Current major depression\r\n\r\n          -  History of bipolar disorder\r\n\r\n          -  Recent (within twelve months) myocardial infarction\r\n\r\n          -  Any other medical condition that would contraindicate use of NRT or bupropion\r\n\r\n          -  Physical limitation so severe that participation in a program of moderate exercise is\r\n             not possible\r\n\r\n          -  Pregnancy or lactation\r\n      ","sponsor":"National Institute on Drug Abuse (NIDA)","sponsor_type":"NIH","conditions":"Tobacco Use Disorder","interventions":[{"intervention_type":"Drug","name":"Drug: Bupropion and NRT","description":"All participants receive standard 12 week treatment of NRT, bupropion and five group counseling sessions. At week 11, subjects are randomly assigned to one of five treatment groups (1) Bupropion/Low Contact; (2) Placebo/Low Contact; (3) Bupropion/Relapse Prevention; (4) Placebo/Relapse Prevention; (5) No Further Treatment. Data is collected at Week 0, and at weeks 12, 24, 52, 64, and 104."}],"outcomes":[{"outcome_type":"primary","measure":"Smoking Behavior","time_frame":"2"}]}
{"nct_id":"NCT01000519","start_date":"2002-12-31","phase":"N/A","enrollment":60,"brief_title":"Effects of Different Mode of Exercise Training on Type 2 Diabetes","official_title":"Differential Effects of Aerobic Versus Progressive Resistance Training on Metabolic Profile and Fitness in Older Adults With Diabetes Mellitus - a Randomized Controlled Trial","primary_completion_date":"2006-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2006-06-30","last_update":"2017-02-10","description":"Randomized study on the comparison between aerobic training versus progressive resistance training over a 2 months period for older adults with type 2 diabetes. The hypothesis is that progressive resistance training is just as effective as aerobic training on Hba1c and could be an alternative training for those older diabetic patients who cannot participate in aerobic exercise.","other_id":"NMRC/0728/2003","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":50,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  aged 50 years and above,\r\n\r\n          -  Hba1c between 8 to 10 % in the past one month,\r\n\r\n          -  sedentary,\r\n\r\n          -  able to continuously walk for at least 20 minutes and climbed one flight of stairs\r\n             unaided without stopping were eligible for participation.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  uncontrolled diabetes mellitus with Hba1c more than 10% or if escalation of treatment\r\n             of glycemic control or dyslipidemia was likely to be necessary over the 2 months\r\n             training period period,\r\n\r\n          -  congestive cardiac failure, unstable angina or acute myocardial infarction within the\r\n             last one year,\r\n\r\n          -  proliferative diabetic retinopathy,\r\n\r\n          -  uncontrolled hypertension,\r\n\r\n          -  advanced arthritis likely to limit mobility or participation in prescribed exercises,\r\n\r\n          -  respiratory conditions such as asthma and chronic obstructive lung disease,\r\n\r\n          -  significant proteinuria or chronic renal insufficiency,\r\n\r\n          -  received drugs for the treatment of obesity or very low caloric diet (VLCD, less than\r\n             1000 kcal/ day),\r\n\r\n          -  renal disease and\r\n\r\n          -  inability to monitor glucose level or comply with exercise program.\r\n      ","sponsor":"Singapore General Hospital","sponsor_type":"Other","conditions":"Diabetes Mellitus, Type 2","interventions":[{"intervention_type":"Other","name":"Other: Aerobic Training","description":"18 sessions over 2 months period. Each session consist of 50 minutes of aerobic training at 65-70 % of maximum predicted heart rate"},{"intervention_type":"Other","name":"Other: Progressive resistance training","description":"18 sessions completed in 2 months. each session consists of 50 minutes of resistance training which is made up of 3 sets of 10 repetitions of nine resistive exercises using machines and free weights at 65-70% of 1-repetitive maximum."}],"outcomes":[{"outcome_type":"primary","measure":"Hemoglobin A, Glycosylated (Hba1c). Measuring unit: percentage","time_frame":"2 months","description":"Blood was drawn from each subject who fasted at least 10 hours overnight. Hba1c (%) was measured using high performance liquid chromatography (HPLC Variant II Bio Rad Laboratories, Munich, Germany). Change in Hba1c before and after intervention were looked at."},{"outcome_type":"secondary","measure":"Peak volume of oxygen consumed (VO2peak) or fitness level. Measuring unit: ml/kg/min","time_frame":"2 months","description":"Modified Bruce protocol on a treadmill using Cosmed K4B2 machine to measure"},{"outcome_type":"secondary","measure":"Anthropometric measurements","time_frame":"2 months","description":"weight (kilogram), height (metres), body mass index (BMI), waist circumference (centimeters) and body fat (percentage). Measurements to be taken before and after intervention."},{"outcome_type":"secondary","measure":"Cholesterol","time_frame":"2 months","description":"Blood was drawn from each subject who fasted at least 10 hours overnight. Total cholesterol and triglycerides (TG) were measured using enzymatic colorimetric methods with cholesterol oxidase-peroxidase amino phenazone phenol and glycerol-3-phospahte oxidase-peroxidase amino phenazone phenol. High-density lipoprotein cholesterol (HDL-C) was measured using homogenous enzymatic colorimetric assay. Low-density lipoprotein cholesterol (LDL-C) was calculated using the Friedewald formula."}]}
{"nct_id":"NCT00341367","start_date":"2002-12-10","enrollment":320,"brief_title":"Blood Sample Donations to Study the Role of Genes in Pain","official_title":"Genetic Risk of Chronic Pain After Acute Sciatica","study_type":"Observational","rec_status":"Completed","completion_date":"2010-03-11","last_update":"2017-07-02","description":"This study attempts to identify genes that may increase or decrease the likelihood of sciatic pain (shooting pain down the leg) persisting 1 year after treatment of a herniated spinal disc. Many proteins in the nerves, spinal cord, and brain are involved in processing pain. These proteins vary slightly in different people. Animal studies have shown that rats and mice with certain types of proteins experience chronic pain after sciatic injury while those with other types do not. Better information about the role of genes in pain processing may lead to a test for the risk of chronic pain for specific individuals and more effective treatment approaches. This study will include people who participated in the Maine Lumbar Pain Study of the natural history of spinal pain. The Maine study included patients treated for sciatic pain caused by a herniated disc. In this study, patients who did not improve with medical treatment were referred for surgery to remove the disc. Of those referred for surgery, 275 elected to have the operation, and 232 did not. One year after surgical consultation, leg pain was reduced in 81 percent of patients who underwent surgery. Of those who declined surgery, 56 percent improved after 1 year. This study will look for genetic differences in the non-surgical group that might reveal differences among those who improved and those who did not. Participants will provide a blood sample (approximately 2 tablespoons) for genetic testing. They will also provide information on the ethnic background of their parents and grandparents. Different gene variants occur in different ethnic groups, so information on ethnic background will help researchers know what gene variants to look for. Participants will complete a questionnaire about their smoking history, because the same protein in the brain that responds to nicotine may also play a part in decreasing or increasing pain. Also, some surgeons believe that smoking can interfere with spinal bone healing. Information from this study will help resolve this question. ...","other_id":"999903070","sampling_method":"","gender":"All","population":"","criteria":"\n        -  INCLUSION CRITERIA:\r\n\r\n        Presented to Maine orthopedic or neurosurgeon approximately 10 years ago with complaint of\r\n        sciatica and was enrolled in Maine Lumbar Spine Study.\r\n\r\n        Outcome dataset includes ratings of low back and leg pain at baseline and at least one\r\n        followup evaluation.\r\n      ","sponsor":"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","sponsor_type":"NIH","conditions":"Pain","interventions":{},"outcomes":{}}
{"nct_id":"NCT00035919","start_date":"2002-11-30","phase":"Phase 1/Phase 2","enrollment":0,"brief_title":"Safety and Efficacy of Targeted Gene Transfer in Colorectal Cancer Metastatic to Liver","official_title":"Tumor Site Specific Phase I Evaluation of Safety of Hepatic Arterial Infusion of a Matrix-Targeted Retroviral Vector Bearing a Dominant Negative Cyclin G1 Construct as Intervention for Colorectal Carcinoma Metastatic to Liver","study_type":"Interventional","rec_status":"Withdrawn","completion_date":"2003-10-31","last_update":"2014-05-22","description":"This is a Phase I safety study of a gene transfer drug for colorectal cancer that has spread to the liver. The main purpose of this study is to determine if it is safe to give this new intervention to persons with cancer, but we will also look for indications that the drug is effective. Although the findings in animals that have cancer are encouraging, this is the first time humans will receive this experimental gene transfer drug. A gene called cyclin G1 has been shown to play a very important part in cancer growth. In animal experiments, a genetically modified virus (or vector)carrying a modified cyclin G1 gene caused the cancerous tumors to grow much slower or even die. In this safety study, the drug will be injected through the liver artery to get it near the cancer that has spread to the liver. The way the gene gets into the cancer cells is by using a targeted vector that concentrates in the area of the cancer to improve the delivery of the killing gene into cancer cells. The vector we are using is a virus that has been changed so that the infectious genes have been removed and instead carries the modified cyclin G1 gene.","other_id":"3C-01-2","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria: Patients will be considered candidates for the proposed protocol if the\r\n        patients have failed standard chemotherapy regimens (5-FU, LV and CPT-11), in the judgment\r\n        of the principal investigator, and meet the following criteria:\r\n\r\n          1. Histologically or cytologically confirmed colorectal carcinoma metastatic to liver,\r\n             which is unresectable based on the judgment of the patient's surgeon) and is\r\n             radiologically measurable.\r\n\r\n          2. Adequate hepatic function: Total bilirubin < 2.0 mg/dL (upper limit included); AST/ALT\r\n             < 2x institutional norm; alkaline phosphatase < 3x upper limit of institutional norm,\r\n             albumin > 3.0 mg/dL. There must be no substantial ascites. PT and PTT must be within\r\n             normal limits.\r\n\r\n          3. Performance status must be 0-1 (SWOG 0-1) with a life expectancy of at least 3 months.\r\n\r\n          4. Absolute granulocyte count > 1000/uL, and platelet count > 100,000/uL.\r\n\r\n          5. Calculated creatinine clearance > 60ml/hour.\r\n\r\n          6. There must be no plans for the patient to receive further cancer therapy from the date\r\n             of enrollment until the completion of the 12 week follow-up visit.\r\n\r\n          7. Installation of a functional hepatic arterial infusion (HAI) with satisfactory\r\n             positioning of the catheter in a primary branch of the hepatic artery, placed within\r\n             the prior 6 months to three weeks. If the patient does not presently have a hepatic\r\n             artery infusion pump in place, a pump can be placed for them so that they might\r\n             qualify to participate in the intervention and follow-up phases of this clinical\r\n             trial.\r\n\r\n          8. Age > 18 years, in order to protect children or minors from the potential risks of a\r\n             new drug that has not yet been tested in adults.\r\n\r\n          9. The ability to understand and the willingness to sign a written informed -consent\r\n             document.\r\n\r\n        Exclusion Criteria\r\n\r\n          1. Prior malignancy, except for non-melanoma skin cancer, stage I breast cancer, CIS of\r\n             cervix from which the patient has been disease free for 5 years.\r\n\r\n          2. Woman who are pregnant or nursing\r\n\r\n          3. Fertile patients unless they agree to use barrier contraception (condoms and\r\n             spermicide jelly) during the vector infusion period and for six weeks after infusion.\r\n\r\n          4. Patients with medical, psychiatric, or social conditions that would compromise\r\n             successful adherence to this protocol.\r\n\r\n          5. Patients with indwelling biliary stents or a recent history of cholangitis, hepatitis,\r\n             presence of disseminated intravascular coagulopathy, or HIV infection. Patients must\r\n             not have a history of recent myocardial infarction (within one year) or evidence of\r\n             congestive heart failure.\r\n\r\n          6. Patients with a history of bleeding varices in the prior 3 months.\r\n\r\n          7. Patients who have received any other antitumor treatment (chemotherapy, radiation,\r\n             immunotherapy) within 4 weeks of study entry or who have not recovered from previous\r\n             therapy or within 6 weeks for mitomycin C and nitrosureas.\r\n      ","sponsor":"University of Southern California","sponsor_type":"Other","conditions":"Colorectal Neoplasms","interventions":[{"intervention_type":"Genetic","name":"Genetic: Mx-dnG1 Retroviral Vector"}],"outcomes":[{"outcome_type":"primary","measure":"dose-limiting toxicity and maximum tolerated dose"},{"outcome_type":"secondary","measure":"objective tumor response by CT scan or MRI"}]}
{"nct_id":"NCT00521976","start_date":"2002-11-30","enrollment":871,"brief_title":"Risk Markers in the Acute Coronary Syndromes","official_title":"An Investigation of Activated Factor XII (Fxlla) as a Prognostic Marker.","primary_completion_date":"2005-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2005-12-31","last_update":"2015-06-15","description":"The main aim of this trial is to assess the long-term prognostic value of different types of Factor XIIa in an unselected, single center series of 871 chest pain patients admitted to the emergency unit, employing blood samples collected at admission. The second purpose of this study is to assess the incremental prognostic value of B-type natriuretic peptide (BNP) and high-sensitive C-reactive protein (hsCRP). A third purpose of this study is to evaluate the prognostic impact of the Omega-3 Index which is a measure of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) relative to other fatty acids in the erythrocyte membrane.","other_id":"NSD9253","observational_model":"Cohort","time_perspective":"Prospective","sampling_method":"Probability Sample","gender":"All","minimum_age":18,"population":"871 men and women admitted with chest pain and potential acute cornary syndrome (ACS) at\r\n        the Stavanger University Hospital between November 2002 and October 2003.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  adults > 18 years able to give informed consent\r\n\r\n          -  a history of chest pain or other symptoms suggestive of an ACS leading to admission at\r\n             the emergency unit\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  < 18 years of age\r\n\r\n          -  Unwillingness or incapacity to provide informed consent\r\n\r\n          -  Prior admission resulting in inclusion in the present study\r\n      ","sponsor":"Helse Stavanger HF","sponsor_type":"Other","conditions":"Chest Pain|Coronary Artery Disease|Unstable Angina Pectoris|Myocardial Infarction","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Total Mortality.","time_frame":"24 months."},{"outcome_type":"secondary","measure":"Recurrent Troponin-T (TnT) Positive Events","time_frame":"24 months.","description":"Recurrent Troponin-T (TnT) positive events; Symptoms of coronary ischemia associated with TnT >0.05 ng/mL with a pattern of gradual rise and fall in TnT"}]}
{"nct_id":"NCT00602381","start_date":"2002-11-30","phase":"N/A","enrollment":30,"brief_title":"Bioequivalency Study of 450 mg Lithium Carbonate Under Fasting Conditions","official_title":"A Single Dose, Three-Treatment, Three-Period, Six-Sequence Crossover Bioequivalency Study of 450 mg Lithium Carbonate Extended Release Tablets Under Fasting Conditions","primary_completion_date":"2002-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2002-11-30","last_update":"2018-01-23","description":"The objective of this study was to assess the bioequivalence of two Roxane lithium carbonate 450 mg extended release tablet formulations compared to GlaxoSmithKline's Eskalith CR 450 mg extended release tablet under fasting conditions using a single-dose, randomized, three-treatment, three-period, six-sequence crossover design.","other_id":"LITH-08","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":25,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  No clinically significant abnormal findings on the physical examination, medical\r\n             history, or clinical laboratory results during screening.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Participation in a clinicl trial within 30 days prior to study initiation.\r\n\r\n          -  Positive test for HIV, Hepatitis B, or Hepatitis C.\r\n\r\n          -  Treatment with known enzyme altering drugs.\r\n      ","sponsor":"Roxane Laboratories","sponsor_type":"Industry","conditions":"Bipolar Disorder","interventions":[{"intervention_type":"Drug","name":"Drug: Lithium"}],"outcomes":[{"outcome_type":"primary","measure":"Bioequivalence","time_frame":"Baseline, Three period, Fourteen day washout"}]}
{"nct_id":"NCT00052416","start_date":"2002-10-31","phase":"Phase 1","brief_title":"Thalidomide in Treating Patients With Asymptomatic, Indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia","official_title":"Thalidomide in Indolent Non-Hodgkin's Lymphoma: A Feasibility Study","study_type":"Interventional","rec_status":"Completed","completion_date":"2003-01-31","last_update":"2013-06-26","description":"RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. PURPOSE: Phase I trial to determine the effectiveness of thalidomide in treating patients who have asymptomatic, indolent non-Hodgkin's lymphoma or chronic lymphocytic leukemia.","other_id":"BIDMC-W-01-0384-FB","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        DISEASE CHARACTERISTICS:\r\n\r\n          -  Histologically confirmed indolent lymphoma or leukemia of one of the following\r\n             subtypes:\r\n\r\n               -  Chronic lymphocytic leukemia\r\n\r\n               -  Follicular center lymphoma (grade I or II)\r\n\r\n               -  Lymphoplasmacytic lymphoma\r\n\r\n               -  Marginal zone lymphoma (nodal, extranodal, or splenic)\r\n\r\n               -  Small lymphocytic lymphoma\r\n\r\n               -  Waldenstrom's macroglobulinemia\r\n\r\n          -  Any stage of disease allowed\r\n\r\n          -  No hairy cell leukemia\r\n\r\n          -  No T-cell lymphomas\r\n\r\n          -  No prior treatment for lymphoma/leukemia\r\n\r\n          -  Considered appropriate for expectant management\r\n\r\n               -  Must not require cytotoxic therapy\r\n\r\n        PATIENT CHARACTERISTICS:\r\n\r\n        Age\r\n\r\n          -  18 and over\r\n\r\n        Performance status\r\n\r\n          -  ECOG 0-1\r\n\r\n        Life expectancy\r\n\r\n          -  Not specified\r\n\r\n        Hematopoietic\r\n\r\n          -  Absolute neutrophil count at least 1,500/mm^3\r\n\r\n          -  Hemoglobin greater than 10.0 g/dL\r\n\r\n          -  Platelet count greater than 75,000/mm^3\r\n\r\n        Hepatic\r\n\r\n          -  Bilirubin no greater than 2 times normal\r\n\r\n          -  AST and ALT no greater than 2 times normal\r\n\r\n        Renal\r\n\r\n          -  Creatinine no greater than 2.0 mg/dL\r\n\r\n        Cardiovascular\r\n\r\n          -  No uncontrolled congestive heart failure\r\n\r\n          -  No New York Heart Association class III or IV heart disease\r\n\r\n          -  No unstable coronary artery disease\r\n\r\n          -  No myocardial infarction in the past 6 months\r\n\r\n          -  No serious or uncontrolled arrhythmias\r\n\r\n          -  No history of thromboembolic disease\r\n\r\n        Pulmonary\r\n\r\n          -  No asthma or chronic obstructive pulmonary disease requiring the use of home oxygen or\r\n             frequent oral steroids (prednisone greater than 20 mg per day for 5 days within the\r\n             past 3 months)\r\n\r\n        Other\r\n\r\n          -  HIV negative\r\n\r\n          -  Not pregnant or nursing\r\n\r\n          -  Negative pregnancy test\r\n\r\n          -  Not planning to become pregnant in the next 2 years\r\n\r\n          -  Fertile female patients must use 1 highly effective method and 1 additional effective\r\n             method of contraception for 1 month prior to, during, and for 1 month after study\r\n             participation\r\n\r\n          -  Male patients must use effective barrier contraception during and for 1 month after\r\n             study participation\r\n\r\n          -  Willing and able to participate in the S.T.E.P.S. (System for Thalidomide Education\r\n             and Prescribing Safety) program\r\n\r\n          -  No contraindications to meeting the requirements of the S.T.E.P.S. program\r\n\r\n          -  No other prior malignancy except curatively treated non-melanoma skin cancer or\r\n             carcinoma in situ of the cervix\r\n\r\n          -  No peripheral neuropathy\r\n\r\n          -  No poorly controlled diabetes defined by either of the following:\r\n\r\n               -  Glycosylated hemoglobin greater than 8.0 g/dL\r\n\r\n               -  Known end organ disease (i.e., nephropathy, retinopathy, or neuropathy)\r\n\r\n          -  No other concurrent illness that would preclude study therapy\r\n\r\n        PRIOR CONCURRENT THERAPY:\r\n\r\n        Biologic therapy\r\n\r\n          -  Not specified\r\n\r\n        Chemotherapy\r\n\r\n          -  See Disease Characteristics\r\n\r\n        Endocrine therapy\r\n\r\n          -  Not specified\r\n\r\n        Radiotherapy\r\n\r\n          -  Not specified\r\n\r\n        Surgery\r\n\r\n          -  Not specified\r\n      ","sponsor":"Beth Israel Deaconess Medical Center","sponsor_type":"Other","conditions":"Leukemia|Lymphoma","interventions":[{"intervention_type":"Drug","name":"Drug: thalidomide"}],"outcomes":{}}
{"nct_id":"NCT00069472","start_date":"2002-10-31","enrollment":1062,"brief_title":"Genetic Registry for Rheumatoid Arthritis","official_title":"Genetics of Rheumatoid Arthritis Registry","primary_completion_date":"2015-08-31","study_type":"Observational","rec_status":"Completed","completion_date":"2015-08-31","last_update":"2015-09-10","description":"Many genes are thought to contribute to rheumatoid arthritis (RA). This study will attempt to identify genes that may contribute to RA.","other_id":"NIAMS-107","observational_model":"Family-Based","time_perspective":"Cross-Sectional","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Persons with RA who have two living biological parents. Parents can be affected or\r\n        unaffected with RA. We call the family units \"trios\".","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Adult onset RA\r\n\r\n          -  Diagnosis of RA made between 18 and 60 years old\r\n\r\n          -  Both parents alive and willing to participate\r\n\r\n          -  Parents may have diagnosis of RA (affected) or be unaffected\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Inflammatory bowel disease\r\n\r\n          -  Lupus\r\n\r\n          -  Psoriatic arthritis\r\n      ","sponsor":"Northwell Health","sponsor_type":"Other","conditions":"Rheumatoid Arthritis","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Genetic Association with risk for rheumatoid arthritis","time_frame":"10 years","description":"The project aims to identify risk alleles for rheumatoid arthritis using association methods in trio families, combined with data from singleton cases and multiplex families"}]}
{"nct_id":"NCT00764153","start_date":"2002-10-31","phase":"N/A","enrollment":222,"brief_title":"Hemiarthroplasty or Internal Fixation for Displaced Femoral Neck Fractures - 5 Years Follow up","official_title":"Hemiarthroplasty or Internal Fixation for Displaced Femoral Neck Fractures - 5 Years Follow up","primary_completion_date":"2011-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-12-31","last_update":"2014-10-23","description":"An estimated 1.6 million patients sustain a hip fracture every year, about half of these are intracapsular femoral neck fractures. A femoral neck fracture is a life changing event for any patient, and the risk of disability, increased dependence and death is substantial. The main treatment options for displaced femoral neck fractures are internal fixation and arthroplasty. It is established that there are more complications and reoperations after internal fixation, and better short term clinical results with arthroplasty, but knowledge about long term results is lacking.","other_id":"12-2005-OS-2","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Displaced femoral neck fracture\r\n\r\n          -  Age 60 or above\r\n\r\n          -  Able to walk (any aids allowed)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Anesthesiologically unfit for arthroplasty surgery\r\n\r\n          -  Previous symptomatic hip pathology (i.e. arthritis)\r\n\r\n          -  Pathological fracture\r\n\r\n          -  Delay of more than 96 hours from injury to treatment\r\n\r\n          -  Not living in hospital area\r\n      ","sponsor":"Ullevaal University Hospital","sponsor_type":"Other","conditions":"Femoral Neck Fractures","interventions":[{"intervention_type":"Procedure","name":"Procedure: Bipolar hemiarthroplasty","description":"Lateral approach. FWB."},{"intervention_type":"Procedure","name":"Procedure: Internal fixation","description":"Fluoroscopic Control. Percutaneous. FWB. Two parallel screws (Olmed)"}],"outcomes":[{"outcome_type":"primary","measure":"Harris Hip Score","time_frame":"5-6 years"},{"outcome_type":"secondary","measure":"Eq-5d","time_frame":"5-6 years"},{"outcome_type":"secondary","measure":"Barthel Index","time_frame":"5-6 years"},{"outcome_type":"secondary","measure":"Reoperations and complications","time_frame":"5-6 years"}]}
{"nct_id":"NCT00096343","start_date":"2002-10-31","phase":"Phase 2","enrollment":31,"brief_title":"Paclitaxel and Carboplatin in Treating Women Who Are Undergoing Surgery for Newly Diagnosed, Locally Advanced Breast Cancer","official_title":"A Phase II Trial of Pre-Operative Taxol and Carboplatin in Women With Newly Diagnosed Locally Advanced Operable Breast Cancer","primary_completion_date":"2005-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2005-03-31","last_update":"2018-12-04","description":"RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy before surgery may shrink the tumor so that it can be removed. Combining paclitaxel with carboplatin may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin works in treating women who are undergoing surgery for newly diagnosed, locally advanced breast cancer.","other_id":"CDR0000377728","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":120,"population":"","criteria":"\n        DISEASE CHARACTERISTICS:\r\n\r\n          -  Histologically confirmed invasive ductal carcinoma or invasive lobular carcinoma of\r\n             the breast meeting the following stage criteria:\r\n\r\n               -  T2, T3, or T4a-c\r\n\r\n               -  N0-2\r\n\r\n               -  M0\r\n\r\n          -  Inflammatory breast cancer (stage IIIB) allowed\r\n\r\n          -  Measurable disease by mammogram or ultrasound\r\n\r\n          -  Hormone receptor status:\r\n\r\n               -  Not specified\r\n\r\n        PATIENT CHARACTERISTICS:\r\n\r\n        Age\r\n\r\n          -  18 and over\r\n\r\n        Sex\r\n\r\n          -  Female\r\n\r\n        Menopausal status\r\n\r\n          -  Not specified\r\n\r\n        Performance status\r\n\r\n          -  ECOG 0-1\r\n\r\n        Life expectancy\r\n\r\n          -  Not specified\r\n\r\n        Hematopoietic\r\n\r\n          -  Absolute neutrophil count  1,500/mm^3\r\n\r\n          -  Platelet count  100,000/mm^3\r\n\r\n          -  Hemoglobin  10 g/dL\r\n\r\n        Hepatic\r\n\r\n          -  AST and ALT  1.5 times upper limit of normal (ULN)\r\n\r\n        Renal\r\n\r\n          -  Creatinine  1.2 times ULN OR\r\n\r\n          -  Creatinine clearance  50 mL/min\r\n\r\n        Other\r\n\r\n          -  Not pregnant or nursing\r\n\r\n          -  Negative pregnancy test\r\n\r\n          -  Fertile patients must use effective contraception\r\n\r\n          -  No comorbid medical condition that would preclude study participation\r\n\r\n          -  No comorbid infection that would preclude study participation\r\n\r\n          -  No clinically significant peripheral neuropathy (> grade 1)\r\n\r\n          -  No prior significant allergic reaction to drugs containing Cremophor, such as\r\n             teniposide, cyclosporine, or vitamin K\r\n\r\n          -  No dementia or altered mental status that would prohibit understanding of informed\r\n             consent\r\n\r\n          -  No other primary malignancy except non-melanoma skin cancer or carcinoma in situ of\r\n             the cervix\r\n\r\n        PRIOR CONCURRENT THERAPY:\r\n\r\n        Biologic therapy\r\n\r\n          -  No concurrent prophylactic growth factors\r\n\r\n        Chemotherapy\r\n\r\n          -  No prior chemotherapy\r\n\r\n        Endocrine therapy\r\n\r\n          -  Not specified\r\n\r\n        Radiotherapy\r\n\r\n          -  Not specified\r\n\r\n        Surgery\r\n\r\n          -  At least 3 weeks since prior surgery\r\n\r\n        Other\r\n\r\n          -  No other concurrent anticancer drugs\r\n      ","sponsor":"University of Alabama at Birmingham","sponsor_type":"Other","conditions":"Breast Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: carboplatin"},{"intervention_type":"Drug","name":"Drug: paclitaxel"}],"outcomes":[{"outcome_type":"primary","measure":"Determine the clinical and pathological response in women with newly diagnosed, locally advanced operable breast cancer treated with neoadjuvant chemotherapy comprising paclitaxel and carboplatin","time_frame":"baseline to 18 months"},{"outcome_type":"secondary","measure":"Evaluate specific biomarkers for prognostic value and as markers for response/resistance in patients treated with this regimen","time_frame":"baseline through 18 months"},{"outcome_type":"secondary","measure":"Determine the tolerability and toxicity of this regimen in these patients.","time_frame":"baseline to 18 months"}]}
{"nct_id":"NCT00642876","start_date":"2002-10-31","phase":"N/A","enrollment":541,"brief_title":"PRESTIGE Cervical Disc Study","official_title":"Investigation of the PRESTIGE Cervical Disc Device at a Single Level for Symptomatic Cervical Disc Disease","primary_completion_date":"2006-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2013-05-31","last_update":"2013-08-02","description":"The purpose of this clinical investigation is to evaluate the safety and effectiveness of the ACD in the single level surgical treatment of patients with symptomatic cervical degenerative disc disease. The primary follow-up information obtained from this clinical investigation are used to support a PMA application for the ACD.","other_id":"PRESTIGE","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        All patients participating in this study must meet all of the following inclusion criteria:\r\n\r\n          1. Cervical degenerative disc disease defined as:\r\n\r\n             intractable radiculopathy and/or myelopathy with at least one of the following items\r\n             producing symptomatic nerve root and/or spinal cord compression which is documented by\r\n             patient history (e.g., neck and/or arm pain], functional deficit, and/or neurological\r\n             deficit, and radiographic studies (e.g., CT, MRI, x-rays, etc).\r\n\r\n               1. herniated disc;\r\n\r\n               2. osteophyte formation;\r\n\r\n          2. One cervical level requiring surgical treatment;\r\n\r\n          3. C3-C4 disc to C6-C7 disc level of involvement;\r\n\r\n          4. Unresponsive to non-operative treatment for approximately six weeks or has the\r\n             presence of progressive symptoms or signs of nerve root/spinal cord compression in the\r\n             face of continued non-operative management;\r\n\r\n          5. No previous surgical intervention at the involved level or any subsequent,\r\n             planned/staged surgical procedure at the involved or adjacent level(s);\r\n\r\n          6. Is at least 18 years of age, inclusive, at the time of surgery;\r\n\r\n          7. Preoperative Neck Disability Index score > or = 30;\r\n\r\n          8. Has a preoperative neck pain score of > 20 based on the Preoperative Neck and Arm Pain\r\n             Questionnaire.\r\n\r\n          9. If of child-bearing potential, patient is not pregnant at the time of surgery;\r\n\r\n         10. Is willing to comply with the study plan and sign the Patient Informed Consent Form.\r\n\r\n        Exclusion Criteria:\r\n\r\n        A patient meeting any of the following criteria is to be excluded from the study:\r\n\r\n          1. Has a cervical spinal condition other than symptomatic cervical disc disease requiring\r\n             surgical treatment at the involved level;\r\n\r\n          2. Documented or diagnosed cervical instability defined by dynamic (flexion/extension)\r\n             radiographs showing:\r\n\r\n               1. Sagittal plane translation > 3.5 mm or;\r\n\r\n               2. Sagittal plane angulation > 20.\r\n\r\n          3. More than one cervical level requiring surgical treatment;\r\n\r\n          4. Has a fused level adjacent to the level to be treated;\r\n\r\n          5. Has severe pathology of the facet joints of the involved vertebral bodies;\r\n\r\n          6. Previous surgical intervention at the involved level;\r\n\r\n          7. Has been previously diagnosed with osteopenia or osteomalacia;\r\n\r\n          8. Has any of the following that may be associated with a diagnosis of osteoporosis (if\r\n             Yes to any of the below risk factors, a DEXA Scan will be required to determine\r\n             eligibility):\r\n\r\n               1. Postmenopausal Non-Black female over 60 years of age and weighs less than 140\r\n                  pounds.\r\n\r\n               2. Postmenopausal female that has sustained a non-traumatic hip, spine, or wrist\r\n                  fracture.\r\n\r\n               3. Male over the age of 70.\r\n\r\n               4. Male over the age of 60 that has sustained a non-traumatic hip or spine fracture.\r\n\r\n             If the level of BMD is a T score of -3.5 or a T score of -2.5 with vertebral crush\r\n             fracture, then the patient is excluded from the study.\r\n\r\n          9. Has presence of spinal metastases;\r\n\r\n         10. Has overt or active bacterial infection, either local or systemic;\r\n\r\n         11. Has severe insulin dependent diabetes;\r\n\r\n         12. Has chronic or acute renal failure or prior history of renal disease;\r\n\r\n         13. Has fever (temperature > 101 F oral) at the time of surgery;\r\n\r\n         14. Has a documented allergy or intolerance to stainless steel, titanium, or a titanium\r\n             alloy;\r\n\r\n         15. Is mentally incompetent. (If questionable, obtain psychiatric consult);\r\n\r\n         16. Is a prisoner;\r\n\r\n         17. Is pregnant;\r\n\r\n         18. Is an alcohol and/or drug abuser as defined by currently undergoing treatment for\r\n             alcohol and/or drug abuse;\r\n\r\n         19. Has received drugs which may interfere with bone metabolism within two weeks prior to\r\n             the planned date of spinal surgery (e.g., steroids or methotrexate), excluding routine\r\n             perioperative anti-inflammatory drugs;\r\n\r\n         20. Has a history of an endocrine or metabolic disorder known to affect osteogenesis\r\n             (e.g., Paget's Disease, renal osteodystrophy, Ehlers-Danlos Syndrome, or osteogenesis\r\n             imperfecta);\r\n\r\n         21. Has a condition that requires postoperative medications that interfere with the\r\n             stability of the implant or fusion, such as steroids. (This does not include low dose\r\n             aspirin for prophylactic anticoagulation and routine perioperative anti-inflammatory\r\n             drugs);\r\n\r\n         22. Has received treatment with an investigational therapy within 28 days prior to\r\n             implantation surgery or such treatment is planned during the16 weeks following\r\n             Artificial Cervical Disc implantation.\r\n      ","sponsor":"Medtronic Spinal and Biologics","sponsor_type":"Industry","conditions":"Degenerative Cervical Disc Disease","interventions":[{"intervention_type":"Device","name":"Device: Allograft Fusion and ATLANTIS Cervical Plate System","description":"The patients that received the control treatment underwent a single level anterior cervical fusion procedure involving allograft bone and the ATLANTIS Cervical Plate System."},{"intervention_type":"Device","name":"Device: PRESTIGE Cervical Disc","description":"The PRESTIGE Cervical Disc is a stainless steel device that was inserted into the intervertebral disc space. The device is composed of two metal plates that interface via a ball and socket mechanism permitting segmental spinal motion."}],"outcomes":[{"outcome_type":"primary","measure":"The primary endpoint is overall success, which consists of NDI score, neuro status success, with/without FSU disc ht success, no serious AE classified as \"implant/surgical procedure associated\", and no secondary surgical procedure classified as failure","time_frame":"24 months"},{"outcome_type":"secondary","measure":"The secondary outcomes are radiographic success, medical outcomes SF-36 patient survey (MCS & PCS) success, neck pain status, arm pain status, patient satisfaction, patient global perceived effect, gait assessment, foraminal compression test","time_frame":"24 months"}]}
{"nct_id":"NCT00414713","start_date":"2002-10-31","phase":"Phase 4","enrollment":860,"brief_title":"Transfusion Requirements in Gastrointestinal (GI) Bleeding","official_title":"Randomized and Controlled Clinical Trial of Transfusional Requirements in Patients With Acute Gastrointestinal Bleeding.","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2007-12-31","last_update":"2010-12-29","description":"Recently it has been suggested that a restrictive transfusion of units of Red Cells (URC) may improve the outcome of ICU patients with anemia. Furthermore, it has been suggested that the transfusion of URC may be deleterious for the hemostatic process of bleeding lesions, which suggest that a restrictive transfusion may be valuable in patients which gastrointestinal bleeding. Transfusion of URC may also increase portal pressure which may be detrimental to control acute portal hypertensive bleeding. The aim of the present study is to assess whether a restrictive transfusions may improve the outcome of patients with acute nonvariceal gastrointestinal bleeding, and also whether such a restrictive strategy may improve the outcome of bleeding episodes related with portal hypertension. The study will be carried out with a prospective, randomized and controlled design comparing the restrictive transfusion strategy with the usual nonrestrictive transfusional strategy. Overall 860 patients will be included; 430 in each group. The main outcome measure will be survival. All deaths occurred within the 30 days after admission, will be considered. Secondary outcomes will include rebleeding and complications related to treatment, and related to the bleeding episode itself. Portal pressure will be measured to assess the influence of the transfusions strategy on fluctuations of this parameter, and the relationship with the clinical course of bleeding episode. The study will be performed at the Bleeding Unit of our hospital during a period of 3 years.","other_id":"EC/02/102/1729 HCSCSP","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  All patients with acute upper GI hemorrhage who do not have any criterion of\r\n             exclusion.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  < 18 years old.\r\n\r\n          -  Pregnancy.\r\n\r\n          -  Negative of the patient to receive transfusions.\r\n\r\n          -  Negative of the patient to participate in the study.\r\n\r\n          -  Patients with therapeutic restrictions (as terminally ill patients).\r\n\r\n          -  Previous recent surgery requiring transfusion.\r\n\r\n          -  Recent (less than 90 days) or unstable acute myocardic ischemia. Peripheral\r\n             vasculopathy with secondary.\r\n\r\n          -  To have been included in this same study in the 30 previous days.\r\n      ","sponsor":"Fundaci Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau","sponsor_type":"Other","conditions":"Upper Gastrointestinal Bleeding|Cirrhosis|Portal Hypertension","interventions":[{"intervention_type":"Procedure","name":"Procedure: red blood cell transfusion","description":"red blood cell transfusion"}],"outcomes":[{"outcome_type":"primary","measure":"Mortality at the 45th day","time_frame":"45 days"},{"outcome_type":"secondary","measure":"Mortality at the 7th and 45th day","time_frame":"45 days"},{"outcome_type":"secondary","measure":"Rebleeding","time_frame":"45 days"},{"outcome_type":"secondary","measure":"Transfusion requirements","time_frame":"45 days"},{"outcome_type":"secondary","measure":"Liquids requirements","time_frame":"45 days"},{"outcome_type":"secondary","measure":"Portal pressure changes","time_frame":"7 days"},{"outcome_type":"secondary","measure":"Complications","time_frame":"45 days"}]}
{"nct_id":"NCT00114543","start_date":"2002-09-30","phase":"Phase 3","enrollment":1974,"brief_title":"Trial of Aggressive Versus Conservative Phototherapy in Infants <1,000 Grams Birth Weight","official_title":"A Randomized Trial of Aggressive or Conservative Phototherapy for Extremely Low Birth Weight Infants","primary_completion_date":"2005-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-11-30","last_update":"2019-03-22","description":"This multi-center, randomized clinical trial compared different bilirubin levels as thresholds for timing of phototherapy in extremely low birth weight infants. The primary hypothesis was that there would be no difference in death or neurodevelopmental impairment at 18-22 months corrected age in infants treated by either aggressive or conservative threshold limits. 1,978 infants were enrolled.","other_id":"NICHD-NRN-0029","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","maximum_age":36,"population":"","criteria":"\n        Inclusion criteria:\r\n\r\n          -  501-1000 grams birth weight\r\n\r\n          -  12-36 hours postnatal age\r\n\r\n        Exclusion criteria:\r\n\r\n          -  Terminal condition (pH <6.8 for >2 hours OR persistent bradycardia, heart rate <100\r\n             bpm, associated with hypoxia for >2 hours]\r\n\r\n          -  Prior use of phototherapy\r\n\r\n          -  Major congenital anomaly\r\n\r\n          -  Hydrops fetalis or severe hemolytic disease diagnosed in-utero\r\n\r\n          -  Overt congenital nonbacterial infection\r\n\r\n          -  Parental refusal or inability to provide consent\r\n\r\n          -  Attending physician refusal\r\n\r\n          -  Parents who are considered unlikely to return for follow-up evaluation\r\n      ","sponsor":"NICHD Neonatal Research Network","sponsor_type":"Other","conditions":"Hyperbilirubinemia, Neonatal|Jaundice, Neonatal|Infant, Newborn|Infant, Low Birth Weight|Infant, Small for Gestational Age|Infant, Premature","interventions":[{"intervention_type":"Procedure","name":"Procedure: Aggressive Phototherapy 501-750g","description":"Phototherapy started, stopped, and/or restarted when total serum bilirubin levels reach 5 mg/dl during days of life 1-14."},{"intervention_type":"Procedure","name":"Procedure: Aggressive Phototherapy 751-1000g","description":"Phototherapy started, stopped, and/or restarted when total serum bilirubin levels reach 5 mg/dl during days of life 1-7, and started, stopped, and/or restarted when levels reach 7 mg/dl during days of life 8-14."},{"intervention_type":"Procedure","name":"Procedure: Conservative Phototherapy 501-750g","description":"Phototherapy started, stopped, and/or restarted when total serum bilirubin levels reach 8.0 mg/dl during days of life 1-14."},{"intervention_type":"Procedure","name":"Procedure: Conservative Phototherapy 751-1000g","description":"Phototherapy started, stopped, and/or restarted when total serum bilirubin levels reach 10.0 mg/dl during days of life 1-14."}],"outcomes":[{"outcome_type":"primary","measure":"Death or neurodevelopmental impairment (MDI <70; PDI <70; cerebral palsy; blindness; or severe hearing loss)","time_frame":"0-22 months corrected age"},{"outcome_type":"secondary","measure":"Patent ductus arteriosus requiring drug or surgical treatment","time_frame":"36 weeks post conceptual age"},{"outcome_type":"secondary","measure":"Retinopathy of prematurity","time_frame":"36 weeks post conceptual age"},{"outcome_type":"secondary","measure":"Bronchopulmonary dysplasia (BPD)","time_frame":"36 weeks post conceptual age"},{"outcome_type":"secondary","measure":"Ventilator settings and FiO2 at 36 weeks","time_frame":"36 weeks post conceptual age"},{"outcome_type":"secondary","measure":"Necrotizing enterocolitis (NEC)","time_frame":"120 days old or at discharge"},{"outcome_type":"secondary","measure":"Intraventricular hemorrhage (IVH) by grade","time_frame":"120 days old or at discharge"},{"outcome_type":"secondary","measure":"Periventricular leukomalacia","time_frame":"120 days old or at discharge"},{"outcome_type":"secondary","measure":"Sepsis","time_frame":"120 days old or at discharge"},{"outcome_type":"secondary","measure":"Hearing assessments","time_frame":"120 days old or at discharge"}]}
{"nct_id":"NCT00042848","start_date":"2002-08-31","phase":"Phase 3","enrollment":837,"brief_title":"Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer","official_title":"Phase III Randomized, Placebo-Controlled, Double-Blind Trial Of The Effect Of Modafinil On Fatigue In Cancer Patients Receiving Chemotherapy","primary_completion_date":"2007-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-10-31","last_update":"2015-10-15","description":"RATIONALE: Modafinil may be effective in relieving fatigue in patients with cancer who are undergoing chemotherapy. The effectiveness of modafinil in relieving chemotherapy-related fatigue is not yet known. PURPOSE: This randomized phase III trial is studying the effectiveness of modafinil in treating fatigue in patients who are receiving chemotherapy for cancer.","other_id":"CDR0000069477","allocation":"Randomized","primary_purpose":"Supportive Care","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":120,"population":"","criteria":"\n        DISEASE CHARACTERISTICS:\r\n\r\n          -  Diagnosis of cancer\r\n\r\n          -  Concurrently receiving or has previously received chemotherapy and is scheduled for at\r\n             least 3 additional courses of chemotherapy\r\n\r\n               -  Each course of chemotherapy must be at least 2 weeks in duration\r\n\r\n               -  No concurrent radiotherapy or interferon therapy\r\n\r\n          -  Brief Fatigue Inventory question #3 \"fatigue worst\" score of 2 or greater 1 week after\r\n             first chemotherapy course\r\n\r\n        PATIENT CHARACTERISTICS:\r\n\r\n        Age\r\n\r\n          -  18 and over\r\n\r\n        Performance status\r\n\r\n          -  Not specified\r\n\r\n        Life expectancy\r\n\r\n          -  At least 6 months\r\n\r\n        Hematopoietic\r\n\r\n          -  Not specified\r\n\r\n        Hepatic\r\n\r\n          -  No uncontrolled anemia\r\n\r\n        Renal\r\n\r\n          -  Not specified\r\n\r\n        Cardiovascular\r\n\r\n          -  No history of clinically significant cardiac disease, including any of the following:\r\n\r\n               -  Unstable angina\r\n\r\n               -  Left ventricular hypertrophy\r\n\r\n               -  Ischemic echocardiogram changes\r\n\r\n               -  Chest pain\r\n\r\n               -  Arrhythmia\r\n\r\n               -  Other clinically significant manifestations of mitral valve prolapse in\r\n                  association with use of central nervous system stimulants (e.g., caffeine,\r\n                  amphetamines, or methylphenidate)\r\n\r\n          -  No uncontrolled hypertension\r\n\r\n        Gastrointestinal\r\n\r\n          -  Able to swallow medication\r\n\r\n          -  No narrowing (pathological or iatrogenic) or obstruction of the gastrointestinal tract\r\n\r\n        Other\r\n\r\n          -  No severe headaches\r\n\r\n          -  No glaucoma\r\n\r\n          -  No seizure disorder\r\n\r\n          -  No narcolepsy\r\n\r\n          -  No psychotic disorder\r\n\r\n          -  No Tourette's syndrome\r\n\r\n          -  No alcohol or drug abuse\r\n\r\n          -  Not pregnant or nursing\r\n\r\n          -  Fertile patients must use effective barrier contraception during and for at least 1\r\n             full menstrual cycle after study completion\r\n\r\n        PRIOR CONCURRENT THERAPY:\r\n\r\n        Biologic therapy\r\n\r\n          -  See Disease Characteristics\r\n\r\n        Chemotherapy\r\n\r\n          -  See Disease Characteristics\r\n\r\n        Endocrine therapy\r\n\r\n          -  No concurrent chronic corticosteroids\r\n\r\n        Radiotherapy\r\n\r\n          -  See Disease Characteristics\r\n\r\n        Surgery\r\n\r\n          -  Not specified\r\n\r\n        Other\r\n\r\n          -  No prior modafinil\r\n\r\n          -  At least 30 days since prior regular use of psychostimulants (e.g., amphetamines,\r\n             methylphenidate, or pemoline) or monoamine oxidase inhibitors (MAOIs)\r\n\r\n          -  No concurrent alcohol\r\n\r\n          -  Concurrent acetaminophen with codeine or hydrocodone bitartrate allowed\r\n\r\n          -  Concurrent phenytoin allowed\r\n\r\n          -  Concurrent warfarin for anticoagulation and low-dose warfarin (1 mg by mouth daily)\r\n             for maintenance of venous access devices allowed\r\n      ","sponsor":"Gary Morrow","sponsor_type":"Other","conditions":"Fatigue|Unspecified Adult Solid Tumor, Protocol Specific","interventions":[{"intervention_type":"Drug","name":"Drug: modafinil"}],"outcomes":[{"outcome_type":"primary","measure":"Efficacy to reduce fatigue during chemotherapy as assessed by the Brief Fatigue Inventory at course 4"},{"outcome_type":"secondary","measure":"Relationship between depression and fatigue during chemotherapy as assessed by Fatigue Symptom Checklist, Profile of Mood States, Fatigue Severity Scale, Epworth Sleepiness Scale, Center for Epidemiologic Studies-Depression, and Mini-Mac at course 4"}]}
{"nct_id":"NCT01275053","start_date":"2002-07-31","phase":"Phase 1","enrollment":12,"brief_title":"In Vivo Leptin Signaling in Humans After Acute Leptin Administration","official_title":"In Vivo Leptin Signaling in Humans After Acute Leptin Administration","primary_completion_date":"2013-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2017-01-31","last_update":"2017-10-17","description":"The purpose of this research study is to help us to better understand how leptin regulates blood sugar levels. Leptin is a recently discovered hormone, which is made in fat cells. Leptin is secreted by fat and acts as a signal to the brain to decrease appetite and influences how the body regulates blood sugar levels. A synthetic form of leptin (A-100), an investigational drug and has not yet been approved by the Food and Drug Administration (FDA), will be administered to participants in this study. The expected duration of your participation is 3 study visits, which will be spread over 3-4 weeks. This study involves having fat and muscle biopsies after receiving leptin under local anesthesia in the General Clinical Research Center (GCRC), surgical unit, and/or Endocrinology exam room at the Beth Israel Deaconess Medical Center.","other_id":"2002P000097","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  For this pilot study we propose to enroll men and women, ages 18-65 years, with body\r\n             mass index (BMI) ranges meeting lean and obese criteria, and less than or equal to 45\r\n             kg/m2. Obese diabetics will also be included.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  We will exclude subjects who require special diet prior to biopsy. We will exclude\r\n             subjects with a history of any illness, other than obesity and diabetes. Subjects\r\n             taking any medications that are known to influence glucose metabolism such as\r\n             glucocorticoids will also be excluded. Subjects who have a known history of\r\n             anaphylaxis or anaphylactoid-like reactions or who have a known hypersensitivity to E.\r\n             coli-derived proteins or anesthetic agents such as Lidocaine or Novocaine will be\r\n             excluded from the study. Women who are breast feeding, pregnant, or wanting to become\r\n             pregnant during the month following the study may not participate in this study. Women\r\n             participating in this study must use a contraceptive method to prevent pregnancy\r\n             (birth control pills, hormonal implants, intrauterine device (IUD), diaphragm with\r\n             intravaginal spermicide, cervical cap, male or female condom). If a woman suspects\r\n             that she has become pregnant during the study or within one month of completing study,\r\n             or if she does not use one of the contraceptive methods recommended by the\r\n             investigator, she will be instructed to notify the study staff immediately. Subjects\r\n             with a history of bleeding dyscrasia, poor wound healing or any medical condition\r\n             precluding supine position will be excluded from the study.\r\n      ","sponsor":"Beth Israel Deaconess Medical Center","sponsor_type":"Other","conditions":"Lean|Obese|Obese Diabetics","interventions":[{"intervention_type":"Drug","name":"Drug: leptin","description":"0.01mg/kg"}],"outcomes":[{"outcome_type":"primary","measure":"Leptin Signaling","time_frame":"Baseline and 30 minutes","description":"Leptin signaling is assessed before and 30 minutes after in vivo metreleptin administration.\r\nThe primary outcome was p-STAT3/STAT3 in biopsies (fat tissue) before and 30 minutes after in vivo metreleptin administration.\r\nThe p-STAT3/STAT3 before metreleptin administration was given the value 1, and the p-STAT3/STAT3 30 minutes after in vivo metreleptin administration was given the value showing the fold change compared to p-STAT3/STAT3 before metreleptin administration."}]}
{"nct_id":"NCT00598585","start_date":"2002-07-31","phase":"Phase 4","enrollment":12,"brief_title":"Use of Sildenafil (Viagra) to Alter Fatigue, Functional Status and Impaired Cerebral Blood Flow in Patients With CFS","official_title":"Phase 4 Study of the Use of Sildenafil (Viagra) to Alter Fatigue, Functional Status and Impaired Cerebral Blood Flow in Patients With Chronic Fatigue Syndrome.","primary_completion_date":"2010-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-12-31","last_update":"2017-06-27","description":"Use of Viagra to Alter Symptoms in Patients with Chronic Fatigue Syndrome (CFS)","other_id":"02-04-378-07","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":49,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients meeting the CDC definition of CFS.\r\n\r\n          -  All races, ethnicities, socio-economic status (SES), and gender\r\n\r\n          -  Age greater than 18 (because of concerns about radioactivity, we and the Cedars-Sinai\r\n             and Harbor-UCLA IRBs have decided not to enroll subjects below the age of 18).\r\n\r\n          -  Age less than 50. Because of concern of sildenafil exacerbating coronary artery\r\n             disease, we will only enroll patients younger than 50.\r\n\r\n          -  Able to provide informed consent.\r\n\r\n          -  Willingness to be off all medicines and supplements for 3 weeks prior to the study.\r\n\r\n          -  Patients with psychiatric disorders (see below) will be included, if they could be off\r\n             their medications, and if their psychiatric diagnosis clearly occurred after their\r\n             fatigue symptoms began.\r\n\r\n          -  Patients with concurrent fibromyalgia will be allowed to participate if the meet\r\n             diagnostic criteria for CFS.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Disabilities that would prevent them from participating in the study.\r\n\r\n          -  Current use of prescription medicines (starting at 3 weeks prior to the study) and\r\n             supplements (starting at 1 weeks prior to the study) except acetaminophen or aspirin.\r\n             This includes herbal supplements and vitamins.\r\n\r\n          -  Existing medical illnesses, such as heart disease, hypertension, cancer,\r\n             rheumatological diseases, endocrinopathies or hormone replacement therapy, seizure\r\n             disorders, severe obesity (BMI > 32 kg/m2),\r\n\r\n          -  Severe psychiatric disorders including bipolar disorder, schizophrenia, dementia and\r\n             previous or current diagnosis of alcohol or substance abuse within the past year.\r\n             Patients with depression of such severity as to warrant treatment with\r\n             anti-depressants will be excluded.\r\n\r\n          -  Current abuse of illicit drugs or heavy ethanol use.\r\n\r\n          -  Pregnant women will be excluded because of radioactivity exposure from the SPECT\r\n             scans.\r\n\r\n          -  Abnormal EKG\r\n\r\n          -  Abnormal CBC, blood chemistries, thyroid function tests, and HIV, ANA, RF and ESR\r\n             tests.\r\n      ","sponsor":"Charles Drew University of Medicine and Science","sponsor_type":"Other","conditions":"Chronic Fatigue Syndrome","interventions":[{"intervention_type":"Drug","name":"Drug: Sildenafil (Viagra)","description":"25 mg tid of either Sildenafil(Viagra) for first week. 50 mg tid of either Sildenafil (Viagra) for second week. 100 mg tid of either Sildenafil (Viagra) 3rd,4th, 5th and 6th week of study participation."},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Placebo pills 3X/day for 6 weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Change in Fatigue Impact Scale at 6 Weeks","time_frame":"6 weeks","description":"change in fatigue impact scale there are 42 questions. Each question can be answered from 0 (no problem) to 4 (extreme problem), so a higher score indicates more severe fatigue impact. minimum score=0, maximum score =148 values are calculated at baseline and 6 months and the score at 6 months compared to baseline months is calculated"}]}
{"nct_id":"NCT00827736","start_date":"2002-06-30","phase":"Phase 4","enrollment":73,"brief_title":"Comparison of Treatment Success of Botox Injection in the Internal Sphincter Versus Isosorbidedinitrate Ointment in Patients With an Anal Fissure","official_title":"Botulin Toxin Versus Isosorbidedinitrate Ointment in Treatment Anal Fissure; A Prospective, Blinded, Randomized Trial","primary_completion_date":"2006-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2006-03-31","last_update":"2009-01-23","description":"The standard treatment of anal fissure in the netherlands (ISDN ointment) is being compared to a relatively new treatment (injection of Botox in the internal anal sphincter). The study hypothesis is that after 4 months, Botox has healed more patients than ISDN. The comparison is done blinded for the surgeon and the patient.","other_id":"00.058","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Triple","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  all consecutive patients over the age of 18 with a chronic anal fissure presenting to\r\n             our surgical outpatient clinic\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  pregnancy\r\n\r\n          -  previous anal surgery\r\n\r\n          -  Crohn's disease\r\n\r\n          -  systemic causes of an anal fissure\r\n      ","sponsor":"Onze Lieve Vrouwe Gasthuis","sponsor_type":"Other","conditions":"Anal Fissure","interventions":[{"intervention_type":"Procedure","name":"Procedure: Botox","description":"injection of 10U of BT (Botox; Allergan, Irvine, California, USA) in the IAS on each side of the anterior midline."},{"intervention_type":"Drug","name":"Drug: ISDN ointment","description":"application of ISDN 1% ointment 6 times a day"},{"intervention_type":"Drug","name":"Drug: Placebo","description":"Injection of placebo into internal anal sphincter (ISDN ointment arm)\r\nApplied to the anoderm six times a day (Botox injection arm)"}],"outcomes":[{"outcome_type":"primary","measure":"macroscopic healing of the fissure","time_frame":"4 months"},{"outcome_type":"secondary","measure":"complications","time_frame":"12 months"},{"outcome_type":"secondary","measure":"fissure recurrence","time_frame":"12 months"},{"outcome_type":"secondary","measure":"fissure related pain","time_frame":"12 months"},{"outcome_type":"secondary","measure":"costs","time_frame":"12 months"}]}
{"nct_id":"NCT00921076","start_date":"2002-06-30","phase":"Phase 4","enrollment":200,"brief_title":"Gait Analysis of Ankle Arthroplasty and Arthrodesis","official_title":"Gait Analysis of Patients Undergoing Total Ankle Arthroplasty, Ankle Arthrodesis, Tibiotalocalcaneal or Pantalar Fusion.","primary_completion_date":"2014-01-31","study_type":"Interventional","rec_status":"Unknown status","last_update":"2012-12-13","description":"Surgical options for managing hindfoot arthritis include: joint fusion, total ankle joint replacement or osteotomies (realignment) of bones. Fusion of arthritic hindfoot joints has been the accepted method of managing hindfoot arthritis for over a century. Recently, total ankle replacement has evolved as a treatment option for patients with end stage ankle arthritis. A comparison of gait for patients before and after hindfoot fusion or total ankle replacement will give further information about the outcome of this treatment. The principal aim of this project is to assess the effect of total ankle replacement or hindfoot fusion on gait. We are also interested in the outcome of the surgery and its effect on your symptoms (eg. pain and mobility). The results of this study will aid researchers in assessing this new treatment modality. Your involvement in this study is critical for the researchers to further analyze this new form of treatment and your time and involvement is appreciated.","other_id":"SMH 02-035","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":40,"maximum_age":85,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Symptomatic Ankle Arthritis\r\n\r\n          2. Skeletal maturity\r\n\r\n          3. Able to give informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Avascular Necrosis of Talus\r\n\r\n          2. Obesity (BMI >30)\r\n\r\n          3. Prior Ankle fusion or arthroplasty\r\n\r\n          4. Active or prior infection within 12 months\r\n\r\n          5. Medical condition precluding major surgery\r\n\r\n          6. Severe ipsilateral mid or hind foot deformity\r\n\r\n          7. Severe osteoporotic or osteopenic bone\r\n\r\n          8. Neuromuscular impairment\r\n\r\n          9. Age less than 40 years old\r\n\r\n         10. Cognitive or psychiatric impairment prohibiting accurate follow-up\r\n\r\n         11. Pregnancy\r\n\r\n         12. Workers compensation board patients\r\n      ","sponsor":"Unity Health Toronto","sponsor_type":"Other","conditions":"Ankle Arthritis","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Gait Analysis","description":"A computerized motion analysis system to observe the effect of ankle arthroplasty versus ankle arthrodesis on the kinematic behaviour of the foot and ankle during gait."}],"outcomes":[{"outcome_type":"primary","measure":"The primary outcome measure will be micro motion, consisting of component migration and rotation relative to the talus and distal tibia. This will be measured utilizing RSA with bi-planar stereo X-rays taken at several intervals: before weight bearing is","time_frame":"12 months"}]}
{"nct_id":"NCT00274560","start_date":"2002-05-31","phase":"Phase 3","enrollment":653,"brief_title":"A Multiple Dose Comparison of Tiotropium Inhalation Capsules and Salmeterol Inhalation Aerosol.","official_title":"A Multiple Dose Comparison of Tiotropium Inhalation Capsules and Salmeterol Inhalation Aerosol in a 12 Week, Randomized, Double-Blind, Double-Dummy Parallel Group Study in Patients With Chronic Obstructive Pulmonary Disease (COPD).","primary_completion_date":"2003-03-31","study_type":"Interventional","rec_status":"Completed","last_update":"2013-11-11","description":"The objective of the study was to evaluate the degree of improvement in lung function in patients with chronic obstructive pulmonary disease (COPD) after treatment with tiotropium inhalation capsules compared to salmeterol inhalation aerosol .","other_id":"205.264","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":40,"population":"","criteria":"","sponsor":"Boehringer Ingelheim","sponsor_type":"Industry","conditions":"Pulmonary Disease, Chronic Obstructive","interventions":[{"intervention_type":"Drug","name":"Drug: Tiotropium"},{"intervention_type":"Drug","name":"Drug: Salmeterol"}],"outcomes":[{"outcome_type":"primary","measure":"FEV1 area under the curve for the time period of 0 to 12 hours (FEV1 AUC0-12)","time_frame":"12 weeks"},{"outcome_type":"primary","measure":"peak FEV1","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"Trough FEV1: Trough FEV1 was the FEV1 measured prior to dosing","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"Trough and peak FVC and FVC AUC0-12 measured at the same times as FEV1 on each test day","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"Individual FEV1 and FVC measurements at each timepoint","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"Number (%) of patients with at least one exacerbation of COPD","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"time to first exacerbation","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"number of exacerbations","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"number of exacerbation days","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"Average daily occasions of rescue medication [albuterol (salbutamol)] use each week","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"All adverse events","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"Pulse rate measured in conjunction with spirometry","time_frame":"12 weeks"},{"outcome_type":"secondary","measure":"Blood pressure (seated) measured in conjunction with spirometry","time_frame":"12 weeks"}]}
{"nct_id":"NCT00212082","start_date":"2002-04-30","phase":"Phase 2","enrollment":100,"brief_title":"Gene Expression Profiles in Predicting Chemotherapy Response in Breast Cancer","official_title":"Gene Expression Profiles of Breast Cancer Treated With Sequential Adriamycin and Docetaxel in Relation to Tumor Responses","study_type":"Interventional","rec_status":"Completed","last_update":"2008-06-12","description":"We hypothesize that changes in tumor gene expression profiles vary in response to different sequences and types of chemotherapy, and that gene expression changes will correlate with tumor response. We are also looking to correlate drug pharmacokinetics and treatment toxicity with genotype of drug metabolizing enzymes and tranporters.Patients with metastatic breast cancer and who have measurable primary breast tumor will be randomized to one of two alternating sequences of adriamycin and docetaxel. Serial tumor biopsies and plasma samples will be obtained for gene expression and proteomic studies to identify biomarkers that will predict for chemotherapy response.","other_id":"HO B17/02","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Female, age > 18 years.\r\n\r\n          -  Histologic or cytologic diagnosis of breast carcinoma.\r\n\r\n          -  Stage II to IV breast cancer with measurable primary breast tumor, defined as palpable\r\n             tumor with both diameters 2.0cm or greater as measured by caliper.\r\n\r\n          -  Patients must not have received prior chemotherapy or hormonal therapy for the\r\n             treatment of breast cancer.\r\n\r\n          -  Karnofsky performance status of 70 or higher.\r\n\r\n          -  Estimated life expectancy of at least 12 weeks.\r\n\r\n          -  Adequate organ function including the following:\r\n\r\n             - Bone marrow: White blood cells (WBC) >= 3.5 x 109/L Absolute neutrophil (segmented\r\n             and bands) count (ANC) >= 1.5 x 109/L Platelets >= 100 x 109/L Haemoglobin >= 9g/dL\r\n\r\n             - Hepatic: Bilirubin <= 1.5 x upper limit of normal (ULN), ALT or AST <= 2.5x ULN, (or\r\n             <=5 X with liver metastases) Alkaline phosphatase <= 2.5x ULN.\r\n\r\n             - Renal: creatinine <= 1.5x ULN\r\n\r\n               -  Cardiac:\r\n\r\n               -  Adequate cardiac function\r\n\r\n          -  Signed informed consent from patient or legal representative.\r\n\r\n          -  Patients with reproductive potential must use an approved contraceptive method if\r\n             appropriate (eg, intrauterine device, birth control pills, or barrier device) during\r\n             and for three months after the study. Females with childbearing potential must have a\r\n             negative serum pregnancy test within 7 days prior to study enrollment.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior treatment for locally advanced or metastatic breast cancer.\r\n\r\n          -  Treatment within the last 30 days with any investigational drug.\r\n\r\n          -  Concurrent administration of any other tumor therapy, including cytotoxic\r\n             chemotherapy, hormonal therapy, and immunotherapy.\r\n\r\n          -  Active infection that in the opinion of the investigator would compromise the\r\n             patient's ability to tolerate therapy.\r\n\r\n          -  Pregnancy.\r\n\r\n          -  Breast feeding.\r\n\r\n          -  Serious concomitant disorders that would compromise the safety of the patient or\r\n             compromise the patient's ability to complete the study, at the discretion of the\r\n             investigator.\r\n\r\n          -  Poorly controlled diabetes mellitus.\r\n\r\n          -  Second primary malignancy that is clinically detectable at the time of consideration\r\n             for study enrollment.\r\n\r\n          -  Symptomatic brain metastasis.\r\n\r\n          -  History of significant neurological or mental disorder, including seizures or\r\n             dementia.\r\n\r\n          -  Peripheral neuropathy of >= CTC grade 2.\r\n\r\n          -  History of hypersensitivity to drugs formulated in Tween 80, the vehicle used for\r\n             commercial docetaxel formulations.\r\n      ","sponsor":"National University Hospital, Singapore","sponsor_type":"Other","conditions":"Metastatic Breast Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: doxorubicin, docetaxel"}],"outcomes":[{"outcome_type":"primary","measure":"1. Evaluate the impact of adriamycin and docetaxel on tumor gene expression profiles."},{"outcome_type":"primary","measure":"2. Correlate overall tumor response with tumor gene expression profiles."},{"outcome_type":"secondary","measure":"To correlate adriamycin and docetaxel pharmacokinetics with:"},{"outcome_type":"secondary","measure":"1. Genetic polymorphisms of MDR-1, Cyp3A and GSTs."},{"outcome_type":"secondary","measure":"2. Drug toxicity and tumor response."}]}
{"nct_id":"NCT00044525","start_date":"2002-04-30","phase":"Phase 2","enrollment":82,"brief_title":"Evaluation of BAY59-8862 in Taxane-Resistant Metastatic Breast Cancer Patients","official_title":"An Uncontrolled Phase II Study Evaluating the Efficacy and Safety of Intravenous BAY59-8862 in Patients With Taxane-Resistant Metastatic Breast Cancer","primary_completion_date":"2004-02-29","study_type":"Interventional","rec_status":"Completed","completion_date":"2004-02-29","last_update":"2014-12-23","description":"Breast cancer is the most common form of cancer among women in developing countries, accounting for approximately one-fifth of all female cancers in the United States. Although mortality rates are declining in some countries, it remains the leading cause of death in women aged 40-55 years. The median survival for women with metastatic breast cancer is 2-3 years but there is significant variability in this population. The primary goals of treatment in patients with metastatic breast cancer are improvement or maintenance of quality of life and prolongation of survival. The taxanes, paclitaxel and docetaxel, were incorporated into the treatment of metastatic breast cancer in the 1990's. The usefulness of the taxanes is limited by the development of tumor resistance to these agents. This phase II trial with BAY59-8862 will be conducted to determine the anti-tumor efficacy of BAY59-8862 in taxane-resistant metastatic breast cancer.","other_id":"10654","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Female patients with a proven diagnosis of metastatic breast cancer\r\n\r\n          -  Measurable disease as defined by the presence of at least one measurable lesion\r\n\r\n          -  Patients must have received at least 3 weeks of continuous therapy with Taxane\r\n\r\n          -  patient must subsequently develop progressive disease either during treatment or\r\n             within 6 months after treatment\r\n\r\n          -  Patients who failed on hormone therapy\r\n\r\n          -  Life expectancy of at least 12 weeks.\r\n\r\n          -  Adequate bone marrow, liver and kidney function\r\n\r\n          -  Patients with active brain metastases may be included\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Excluded medical conditions like: pre-existing neuropathy, active heart diseases or\r\n             ischemia; surgery within 4 weeks of study entry; serious infections; HIV infection;\r\n             chronic hepatitis B or C; patients with brain metastases must be without a seizure;\r\n             hypersensitivity to taxanes; organ transplants; some previous cancers\r\n\r\n          -  Excluded therapies and medications, previous and concomitant such as: anticancer\r\n             chemotherapy or immunotherapy during the study or within 4 weeks prior to study entry;\r\n             more than two prior anticancer chemotherapy regimens; radiotherapy during study or\r\n             within 4 weeks prior to study entry; bone marrow transplant\r\n\r\n          -  Others: pregnant or breast-feeding patients; women enrolled in this trial must use\r\n             adequate barrier birth control measures during the course of the trial; substance\r\n             abuse, medical, psychological or social conditions that may interfere with the\r\n             patient's participation.\r\n      ","sponsor":"Bayer","sponsor_type":"Industry","conditions":"Breast Neoplasms|Breast Cancer, Metastatic","interventions":[{"intervention_type":"Drug","name":"Drug: BAY59-8862 (Cytotoxic Taxane)","description":"1 h intravenous infusion every 3 weeks"}],"outcomes":{}}
{"nct_id":"NCT00052208","start_date":"2002-03-31","phase":"Phase 1/Phase 2","enrollment":158,"brief_title":"Gefitinib and Radiation Therapy in Treating Patients With Glioblastoma Multiforme","official_title":"A Phase I/II Study of an Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI), ZD 1839 (Iressa), [NSC #715055] With Radiation Therapy in Glioblastoma Multiforme","primary_completion_date":"2005-06-30","study_type":"Interventional","rec_status":"Completed","last_update":"2020-10-30","description":"This phase I/II trial studies the side effects and best dose of gefitinib when given together with radiation therapy and to see how well it works in treating patients with glioblastoma multiforme. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x rays to kill tumor cells. Giving gefitinib together with radiation therapy may be an effective treatment for glioblastoma multiforme.","other_id":"NCI-2013-00849","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histopathologically confirmed glioblastoma multiforme (with areas of necrosis)\r\n\r\n          -  Diagnosis must be made by surgical biopsy or excision\r\n\r\n          -  The tumor must be supratentorial in location\r\n\r\n          -  The patient must have recovered from the effects of surgery, post-operative infection,\r\n             or other complications before study entry\r\n\r\n          -  Radiotherapy must begin =< five weeks after surgery, and Iressa (gefitinib) must begin\r\n             one week prior to radiotherapy\r\n\r\n          -  Patients must have an estimated survival of at least 8 weeks\r\n\r\n          -  Zubrod performance status of 0-1\r\n\r\n          -  A diagnostic contrast-enhanced magnetic resonance imaging (MRI) or computed tomography\r\n             (CT) scan must be performed preoperatively and postoperatively prior to the initiation\r\n             of radiotherapy; preoperative and postoperative scans must be the same type\r\n\r\n          -  Patients diagnosed only by stereotactic biopsy do not require the postoperative scan\r\n\r\n          -  Patients unable to undergo magnetic resonance (MR) imaging because of non-compatible\r\n             devices can be enrolled, provided pre and postoperative CT scans are obtained and are\r\n             of sufficient quality\r\n\r\n          -  Hemoglobin >= 10 grams\r\n\r\n          -  Absolute neutrophil count >= 1500 (ANC) per mm^3\r\n\r\n          -  Platelets >= 100,000 per mm^3\r\n\r\n          -  Blood urea nitrogen (BUN) =< 25 mg\r\n\r\n          -  Creatinine =< 1.5 mg\r\n\r\n          -  Bilirubin =< 2.0 mg\r\n\r\n          -  Serum glutamate pyruvate transaminase (SGPT) or serum glutamic oxaloacetic\r\n             transaminase (SGOT) =< 2 x normal range\r\n\r\n          -  Patients must consent to submission of their tissue/serum\r\n\r\n          -  The patient must sign a study-specific informed consent prior to study entry; if the\r\n             patient's mental status precludes his/her giving informed consent, written informed\r\n             consent may be given by the responsible family member\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Recurrent or multifocal malignant gliomas\r\n\r\n          -  Metastases detected below the tentorium or beyond the cranial vault\r\n\r\n          -  Major medical illnesses or psychiatric impairments which, in the investigator's\r\n             opinion, will prevent administration or completion of protocol therapy\r\n\r\n          -  Previous radiotherapy to the head or neck (except for T1 glottic cancer), resulting in\r\n             overlap of radiation fields\r\n\r\n          -  Active connective tissue disorders, such as lupus or scleroderma which, in the opinion\r\n             of the treating physician, may put the patient at high risk for radiation toxicity\r\n\r\n          -  Previous malignancies, except for non-melanomatous skin cancers and carcinoma in situ\r\n             of the uterine cervix or bladder, unless disease-free for >= 3 years\r\n\r\n          -  Prior chemotherapy or radiosensitizers for cancers of the head and neck region\r\n\r\n          -  Patients with known acquired immune deficiency (AIDS); patients with AIDS require\r\n             complex therapeutic regimens; the pharmacokinetic interactions of these regimens with\r\n             ZD 1839 are unknown and therefore, pose a safety risk related to excess toxicity or\r\n             interference with anti-viral effectiveness\r\n\r\n          -  Patients with known multiple sclerosis, as these patients may have decreased tolerance\r\n             for radiation therapy to the brain\r\n\r\n          -  Pregnant or lactating women, due to possible adverse effects on the developing fetus\r\n             or infant due to study drug\r\n\r\n          -  Patients treated on any other clinical protocols within 30 days prior to study entry\r\n             or during participation in the study\r\n      ","sponsor":"National Cancer Institute (NCI)","sponsor_type":"NIH","conditions":"Adult Giant Cell Glioblastoma|Adult Glioblastoma|Adult Gliosarcoma","interventions":[{"intervention_type":"Drug","name":"Drug: gefitinib","description":"Given PO"},{"intervention_type":"Radiation","name":"Radiation: radiation therapy","description":"Undergo radiation therapy"},{"intervention_type":"Other","name":"Other: laboratory biomarker analysis","description":"Correlative studies"}],"outcomes":[{"outcome_type":"primary","measure":"Maximum tolerated dose of gefitinib defined as the dose at which no patients develop acute grade 5 toxicity and less than 30% of patients developed acute dose limiting toxicity graded by the National Cancer Institute Common Toxicity Criteria v2.0","time_frame":"Within 90 days from the start of radiotherapy treatment"},{"outcome_type":"primary","measure":"Rate of late toxicities associated with gefitinib and standard cranial radiation, graded according to the NCI CTC v2.0","time_frame":"Up to 10 years"},{"outcome_type":"primary","measure":"Overall survival, by EGFR status","time_frame":"Up to 10 years"},{"outcome_type":"secondary","measure":"Progression-free survival","time_frame":"Up to 10 years"}]}
{"nct_id":"NCT00119119","start_date":"2002-02-28","phase":"Phase 3","enrollment":100,"brief_title":"Efficacy and Safety of Pentoxyphilline and Tocopherol on the Fibrosis in Patients With Chronic Hepatitis C","official_title":"Efficacy and Safety of the Association With Pentoxyphilline and Tocopherol on the Fibrosis in Patients With Chronic Hepatitis C","study_type":"Interventional","rec_status":"Terminated","completion_date":"2006-12-31","last_update":"2007-01-12","description":"The fibrosis of liver is a complication of chronic hepatitis C. There is actually no established treatment for fibrosis of the liver. Pentoxyphilline and tocopherol may have an activity on fibrosis. The aim of the study is to analyse the efficacy and the safety of the combination with pentoxyphilline and tocopherol (12 months) on liver fibrosis, in patients with chronic hepatitis C, who are non-long-term responders, or with intolerance or contra-indication to interferon-alfa and ribavirin.","other_id":"ANRSHC10 PENTO","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age between 18 and 75 years\r\n\r\n          -  Chronic hepatitis C defined by positive HCV Ab and HCV RNA and histological proven\r\n             injuries\r\n\r\n          -  Liver biopsy with a size over or equal to 15mm, performed within 3 years of enrolment,\r\n             with a Metavir score of activity from 0 to 2 and fibrosis score of 2 or 3.\r\n\r\n          -  Non long term responders or patients with contra-indication or intolerance to\r\n             interferon alfa or ribavirin\r\n\r\n          -  No anti-viral treatment during the trial\r\n\r\n          -  Signed written informed consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Alcohol consumption over or equal to 40 g/d\r\n\r\n          -  Allergy to tocopherol or pentoxyphilline\r\n\r\n          -  Treatment with platelet anti-aggregates, anti-vitamin K, theophylline, armophylline\r\n\r\n          -  Treatment with tocopherol or pentoxyphilline since the last liver biopsy\r\n\r\n          -  Pregnancy, breast feeding, lack of contraception\r\n\r\n          -  Decompensated cirrhosis, organ graft, chronic renal insufficiency\r\n\r\n          -  BMI over 27\r\n\r\n          -  Diabetes type I or II\r\n\r\n          -  Other etiology of liver disease (HBV, HIV, hemochromatosis, alfa-1 antitrypsin\r\n             deficiency, Wilson's disease, auto-immune hepatitis, drug-related hepatitis)\r\n      ","sponsor":"French National Agency for Research on AIDS and Viral Hepatitis","sponsor_type":"Other","conditions":"Hepatitis C, Chronic|Liver Fibrosis","interventions":[{"intervention_type":"Drug","name":"Drug: pentoxyphilline"},{"intervention_type":"Drug","name":"Drug: tocopherol"}],"outcomes":[{"outcome_type":"primary","measure":"Variation of the percentage of liver fibrosis evaluated with morphometric analysis between the liver biopsies performed at the end and before the trial (defined as significant if over 5 percent)."},{"outcome_type":"secondary","measure":"Variation of fibrosis Metavir score between the two biopsies"},{"outcome_type":"secondary","measure":"Variation of activity Metavir score between the two biopsies"},{"outcome_type":"secondary","measure":"Variation of liver markers of fibrosis : hyaluronate, N-terminal peptide of procollagen III, TNF-alfa and fibrotest"},{"outcome_type":"secondary","measure":"Variation of ALT"}]}
{"nct_id":"NCT00345917","start_date":"2002-02-28","phase":"Phase 2","enrollment":10,"brief_title":"Safety Study in Retinal Transplantation for Retinitis Pigmentosa.","official_title":"Safety Study in Retinal Transplantation for Retinitis Pigmentosa.","primary_completion_date":"2012-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2012-03-31","last_update":"2012-04-11","description":"The long-term goal is to show that retinal transplantation can help to prevent blindness and to restore eyesight in patients with the inherited disease retinitis pigmentosa.","other_id":"20050137","allocation":"Non-Randomized","intervention_model":"Factorial Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":21,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  The subject must have decreased central visual acuity of 20/200 or worse in one eye by\r\n             ETDRS vision testing for a duration of at least one year in the operated eye and have\r\n             the diagnosis of retinitis pigmentosa; vision in the nonoperated eye must be better\r\n             than the operated eye. Vision in the operated eye cannot be better than 20/200.\r\n\r\n          -  Subject is older than 21 years of age\r\n\r\n          -  Patient is willing to return for follow-up visits\r\n\r\n          -  Patient has signed informed consent for retinal transplantation\r\n\r\n          -  Patient has undergone microperimetry and Goldmann visual field testing.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patient having a central visual acuity of better than 20/200 in one eye by ETDRS or\r\n             vision worse than 20/200 in one eye by ETDRS for a duration of less than one year\r\n\r\n          -  Unwilling to sign an informed consent\r\n\r\n          -  Patient under 21 years of age\r\n\r\n          -  Patient having medical problems that are contraindicatory for short-term anesthesia\r\n\r\n          -  Patient unwilling to return for follow-up visits\r\n\r\n          -  The patient has been determined to be pregnant by patient history or by pregnancy\r\n             testing in women of childbearing potential\r\n\r\n          -  A tear of the retinal pigment epithelium\r\n\r\n          -  Any significant ocular disease that has compromised or could compromise vision in the\r\n             study eye and confound analysis of the primary outcome\r\n\r\n          -  Inability to obtain photographs to document fundus condition, including difficulty\r\n             with venous access\r\n\r\n          -  Participating in another ophthalmic clinical trial or use of any other investigational\r\n             new drugs within 12 weeks before the start of study treatment\r\n\r\n          -  Intraocular surgery within the last two months or capsulotomy within the last month in\r\n             the study eye\r\n\r\n          -  Patient who has a history of uveitis, Coat's disease, diabetic retinopathy, glaucoma,\r\n             or a cataract that prevents visualization of the posterior pole\r\n      ","sponsor":"Radtke, Norman D., M.D.","sponsor_type":"Other","conditions":"Retinitis Pigmentosa.","interventions":[{"intervention_type":"Device","name":"Device: Retinal transplantation instrument"},{"intervention_type":"Device","name":"Device: Fetal tissue."}],"outcomes":[{"outcome_type":"primary","measure":"Snellen"},{"outcome_type":"primary","measure":"Visual acuity"},{"outcome_type":"primary","measure":"Microperimetry"},{"outcome_type":"primary","measure":"Goldmann visual field"},{"outcome_type":"primary","measure":"Optical coherent tomography"},{"outcome_type":"primary","measure":"Fluorescein angiography"},{"outcome_type":"secondary","measure":"No rejection of transplant."}]}
{"nct_id":"NCT00628667","start_date":"2002-02-28","phase":"Phase 4","enrollment":120,"brief_title":"Chronic Posterior Laryngitis With Suspected Laryngopharyngeal Reflux","official_title":"A Multicenter, Double -Blind, Placebo-controlled Study to Evaluate the Effects of Esomeprazole 40mg Bid on the Signs and Symptoms of Chronic Posterior Laryngitis With Suspected Laryngopharyngeal Reflux","primary_completion_date":"2003-03-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2003-03-31","last_update":"2011-01-25","description":"This study looks at how effective acid suppression therapy is on symptoms associated with chronic posterior laryngitis (CPL) in patients with documented pharyngeal acid reflux.","other_id":"SH-NEE-0002","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  One or more of the following symptoms present for at least 3 consecutive months:\r\n             throat clearing, cough, globus, sore throat, or hoarseness.\r\n\r\n          -  Patients must complete a run-in diary card, and this will be looked at to ensure met\r\n             the inclusion criteria.\r\n\r\n          -  Must have a total score of 5 or more on the Chronic Posterior Laryngitis Index (CPLI)\r\n             grading system.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  A number of diseases / conditions would preclude a patient from taking part in the\r\n             study, as listed in the protocol.\r\n\r\n          -  If the patient is on certain medications this will also preclude them from taking\r\n             part.\r\n      ","sponsor":"AstraZeneca","sponsor_type":"Industry","conditions":"Chronic Posterior Laryngitis (CPL)","interventions":[{"intervention_type":"Drug","name":"Drug: Esomeprazole","description":"40mg orally twice daily"},{"intervention_type":"Drug","name":"Drug: Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"Daily diary cards and investigator symptom assessment to evaluate the efficacy of acid suppression therapy on symptoms associated with chronic posterior laryngitis (CPL) in patients without documented pharyngeal acid","time_frame":"Dialy diary cards, investigator assessments, laryngoscopy at week 16"},{"outcome_type":"secondary","measure":"Daily diary cards and investigator symptom assessment throughout to evaluate the efficacy of acid suppression therapy on resolution of signs of CPL at weeks 8 and 16 in patients without documented pharyngeal acid reflux.","time_frame":"Dialy diary cards, investigator assessments, laryngoscopy at weeks 8 and 16"},{"outcome_type":"secondary","measure":"Quality of life Questionnaire","time_frame":"Quality of life questionnaire completed at screening and week 16"},{"outcome_type":"secondary","measure":"To evaluate the safety and tolerability by collecting an ongoing record of adverse events.","time_frame":"Ongoing to week 16."}]}
{"nct_id":"NCT00438126","start_date":"2002-01-31","phase":"N/A","enrollment":200,"brief_title":"Family-Centered Diabetes Project - Sharing Wisdom","study_type":"Interventional","rec_status":"Completed","completion_date":"2006-05-31","last_update":"2010-03-02","description":"This is a randomized trial of an educational intervention to reduce the risk of diabetes among urban American Indian women","other_id":"DK47096 (completed)","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  American Indian women\r\n\r\n          -  Aged 18-40 years\r\n\r\n          -  Living in Albuquerque area\r\n\r\n          -  Not having diabetes\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Pregnancy\r\n\r\n          -  Planning to become pregnant within 2 years\r\n\r\n          -  Diagnosed with diabetes fasting blood glucose > 126 planning to move out of town in\r\n             next 2 years\r\n      ","sponsor":"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","sponsor_type":"NIH","conditions":"Prediabetes|Metabolic Syndrome|Overweight|Obesity","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: A lifestyle educational program"}],"outcomes":[{"outcome_type":"primary","measure":"decreased dietary fat intake"},{"outcome_type":"primary","measure":"increased vegetable consumption"},{"outcome_type":"primary","measure":"increased self-reported leisure physical activity"},{"outcome_type":"secondary","measure":"fasting glucose"},{"outcome_type":"secondary","measure":"HOMA"},{"outcome_type":"secondary","measure":"serum free insulin"},{"outcome_type":"secondary","measure":"Body Mass Index"},{"outcome_type":"secondary","measure":"waist circumference"},{"outcome_type":"secondary","measure":"decreased dietary intake of total sugar"},{"outcome_type":"secondary","measure":"decreased time watching television"},{"outcome_type":"secondary","measure":"resting blood pressure"}]}
{"nct_id":"NCT00366561","start_date":"2002-01-31","enrollment":810,"brief_title":"Neonates With Neurological Complications","official_title":"Retrospective Review of Neonates With Neurological Complications Following Cardiac Surgery","primary_completion_date":"2010-04-30","study_type":"Observational","rec_status":"Completed","completion_date":"2010-04-30","last_update":"2014-12-02","description":"The purpose of this retrospective study is to identify all neonates (newborns < 30 days of age) from January 1, 2002 through June 20, 2006 at Children's Healthcare of Atlanta who have suffered neurological complications following cardiac surgery. This retrospective study is important to identify the incidence, care and follow-up of neurological complications at this institution","other_id":"06-139","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","maximum_age":0.08219,"population":"All neonates (newborns < 30 days of age) from January 1, 2002 through June 20, 2006 at\r\n        Children's Healthcare of Atlanta who have suffered neurological complications following\r\n        cardiac surgery.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Children's Healthcare of Atlanta patients\r\n\r\n          -  January 1, 2002 through June 20, 2006\r\n\r\n          -  < 30 days of age\r\n\r\n          -  neurological complications following cardiac surgery\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Those who do not meet inclusion criteria\r\n      ","sponsor":"Children's Healthcare of Atlanta","sponsor_type":"Other","conditions":"Congenital Disorders","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"The purpose of this study was to examine short term outcomes following cardiac surgery in premature neonates.","time_frame":"6 years","description":"In congenital cardiac defects where there was a choice of palliation vs complete anatomic repair, premature neonates underwent palliative procedures more frequently than term neonates. Premature neonates spent more days of mechanical ventilation compared to their term counterparts. Importantly, there was no difference in mortality between the two groups."}]}
{"nct_id":"NCT00157599","start_date":"2002-01-31","phase":"N/A","enrollment":500,"brief_title":"MDA D-Dimer / Recurrent DVT Study","official_title":"A Cohort Study Evaluating the Safety of a Diagnostic Strategy Involving D-Dimer and Compression Ultrasonography in Patients With Suspected Recurrent Deep Vein Thrombosis","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-03-31","last_update":"2011-07-26","description":"To determine whether treatment and further investigation can be safely withheld in patients who present with suspected recurrent deep vein thrombosis (DVT) and have either a (i) negative D-Dimer or (ii) a positive D-Dimer with normal serial compression ultrasound.","other_id":"CTMG-2002-MDA","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Age 18 or older\r\n\r\n          -  Currently suspected for recurrent DVT\r\n\r\n          -  Has a prior history of objectively documented DVT or PE\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Comorbid condition limiting survival to less than 3 months\r\n\r\n          -  History of hypersensitivity to contrast medium\r\n\r\n          -  Renal dysfunction with a creatinine of > 150 mcmol/L\r\n\r\n          -  Treatment with full-dose therapeutic unfractionated or low molecular weight heparin\r\n             that was initiated 24 hours or more prior to eligibility assessment\r\n\r\n          -  Pregnancy or lactation\r\n\r\n          -  Symptomatic for pulmonary embolism\r\n\r\n          -  Absence of symptoms within five days prior to presentation\r\n\r\n          -  Participation in another trial precluding the use of the diagnostic algorithm in this\r\n             study\r\n\r\n          -  Geographically inaccessible for follow-up\r\n\r\n          -  Compression ultrasound, venogram, IPG, or D-dimer performed PRIOR to assessment\r\n      ","sponsor":"McMaster University","sponsor_type":"Other","conditions":"Deep Vein Thrombosis","interventions":[{"intervention_type":"Procedure","name":"Procedure: various diagnostic measures for DVT (e.g., CUS)"}],"outcomes":[{"outcome_type":"primary","measure":"Suspected DVT during follow-up"},{"outcome_type":"primary","measure":"Suspected PE during follow-up"}]}
{"nct_id":"NCT00505505","start_date":"2002-01-31","phase":"Phase 4","enrollment":800,"brief_title":"Intensive Insulin Therapy for Strict Glycemic Control in Neurosurgical Patients: Safety and Efficacy","official_title":"Effects of Intensive Insulin Therapy on Mortality, Morbidity and Long Term Neurologic Outcome in Neurosurgical Intensive Care Patients","study_type":"Interventional","rec_status":"Unknown status","last_update":"2008-08-07","description":"Strict glycemic control improves mortality and morbidity of patients admitted to the postoperative intensive care unit (ICU). The investigators would like to know if this therapy could improve the long term neurologic and cognitive outcomes of patients treated for acute subarachnoid hemorrhage with either a surgical or intravascular approach.","other_id":"1781964","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Subarachnoid hemorrhage\r\n\r\n          -  Traumatic brain injury\r\n\r\n          -  Intracranial hemorrhage\r\n      ","sponsor":"University of Roma La Sapienza","sponsor_type":"Other","conditions":"Subarachnoid Hemorrhage|Traumatic Brain Injury|Intracranial Hemorrhage","interventions":[{"intervention_type":"Drug","name":"Drug: Insulin (Actrapid)","description":"50 UI Actrapid diluted in 50 ml of saline"}],"outcomes":[{"outcome_type":"primary","measure":"Episodes of hypoglycemia"},{"outcome_type":"secondary","measure":"Infection rate","time_frame":"during the study"},{"outcome_type":"secondary","measure":"Vasospasm rate","time_frame":"during the study"},{"outcome_type":"secondary","measure":"Mortality","time_frame":"6 months follow up"},{"outcome_type":"secondary","measure":"Neurologic status","time_frame":"6 months follow up"}]}
{"nct_id":"NCT00180024","start_date":"2002-01-31","phase":"N/A","brief_title":"Characterization of Vascular Effects of Angiotensin II in Dorsal Human Hand Veins.","study_type":"Interventional","rec_status":"Completed","completion_date":"2005-09-30","last_update":"2005-09-16","description":"The hypothesis is tested that stimulation with angiotensin II after blockade of the AT1-receptor results in venodilation in human healthy subjects in vivo.","other_id":"IKPD 01-02","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Educational/Counseling/Training","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  healthy subjects\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  any relevant disease\r\n      ","sponsor":"Technische Universitt Dresden","sponsor_type":"Other","conditions":"Healthy Subjects","interventions":[{"intervention_type":"Drug","name":"Drug: irbesartan (drug)"}],"outcomes":{}}
{"nct_id":"NCT00339443","start_date":"2001-11-06","enrollment":120,"brief_title":"Calibration of Urine pH Strips for NCI Case-Control Studies on Bladder Cancer and Comparison of DNA Yields From Buccal Cells Collected Through Two Different Methods","official_title":"Calibration of Urine pH Strips for NCI Case-Control Studies on Bladder Cancer and Comparison of DNA Yields From Buccal Cells Collected Through Two Different Methods","study_type":"Observational","rec_status":"Completed","completion_date":"2010-05-19","last_update":"2017-07-02","description":"We propose to conduct a pilot study among 30 volunteers from the Division of Cancer Epidemiology and Genetics (DCEG) in order to: (1) select the urine pH strip that most closely correlates with urine pH measured by pH meter for the New England Bladder Cancer Study, (2) calibrate the urine pH strip that was used for the Spanish Bladder Cancer Study against pH measured by a pH meter, and (3) compare the DNA yields from buccal cells obtained from two different methods: mouthwash vs toothbrush-rinse method. Information collected from this pilot study will be used to select and optimize the sample collection protocols in the New England Bladder Cancer Study. At the time of enrollment, study participants will be asked to provide information on age, gender, height, weight, consumption of antacids and calcium supplements, and whether they ate, drank or brushed their teeth in the last hour previous to the buccal cells ample collection. In addition, they will have to measure their urine pH with four different pH strips twice a day (early morning and before dinner) for a week and record the measurements in a diary. During the same week, they will be asked to collect two spot urine samples each day from Monday to Thursday (early morning and before dinner), and one more on Friday morning, and bring them into work in a cooler. Also, they will be asked to collect a continuous 24-hour urine sample during one of the three first days of the week. Urine samples will e picked up by lab personnel from BioReliance, and pH will be measured at their laboratory with the four pH strips again and with a pH meter. Buccal cells sample collection will be completed during the first and the last day of the urine sample collection period. The first day, study participants will be asked to provide a water rinse sample after brushing the inside of their cheeks with a toothbrush, and a week later they will be asked to provide a mouth wash sample consisting of two consecutive rinses with Scope mouthwash. All samples and questionnaire data will be unlinked from personal identifiers after the sample collection is completed. Participants will be compensated with $100 for the inconvenience of participating in this complex study and for their time.","other_id":"999902040","sampling_method":"","gender":"All","population":"","criteria":"\n        -  INCLUSION CRITERIA:\r\n\r\n        Members of the DCEG staff.\r\n      ","sponsor":"National Cancer Institute (NCI)","sponsor_type":"NIH","conditions":"Calibration","interventions":{},"outcomes":{}}
{"nct_id":"NCT00025883","start_date":"2001-10-31","phase":"Phase 2","enrollment":103,"brief_title":"Leptin to Treat Lipodystrophy","official_title":"Long-Term Efficacy of Leptin Replacement in Treatment of Lipodystrophy","primary_completion_date":"2015-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2015-02-28","last_update":"2016-08-16","description":"This study will evaluate the safety and effectiveness of leptin replacement therapy in patients with lipodystrophy (also called lipoatrophy). Patients have a total or partial loss of fat cells. They also lack the hormone leptin, which is produced by fat cells. The leptin deficiency usually causes high blood lipid (fat) levels and insulin resistance that may lead to diabetes. Patients may have hormone imbalances, fertility problems, large appetite, and liver disease due to fat accumulation. Patients age greater than or equal to 6 months with significant lipodystrophy may be eligible for this study. Participants will be admitted to the NIH Clinical Center for 10 days for the following studies before beginning 12 months of leptin therapy: - Insulin tolerance test - Ultrasound of the liver and, if abnormalities are found, possibly liver biopsies. - Fasting blood tests - Resting metabolic rate - Magnetic resonance imaging of the liver and other organs, and of muscle and fat. - Pelvic ultrasound in women to detect ovarian cysts. - Estimation of body fat - Oral glucose tolerance test - Intravenous glucose tolerance test - Appetite level and food intake - Hormone function tests - Questionnaires to assess activity and mood - 24-hour urine collections Additional studies may include blood tests for genetic studies of lipodystrophy, a muscle biopsy to study muscle proteins involved in regulating energy expenditure before and after leptin replacement, and examination of a surgical specimen (if available) to study molecules that may be involved in energy storage and use. When the above tests are completed, leptin therapy begins. The drug is injected under the skin twice a day for 4 months and then once a day, if feasible. The dose is increased at the 1- and 2-month visits. Follow-up visits at 1, 2, 4, 6, 8 and 12 months after therapy starts include a physical examination, blood tests and a meeting with a dietitian. At the end of 12 months, all baseline studies described above are repeated. Patients record their symptoms weekly throughout the study. Those with diabetes measure their blood glucose levels daily before each meal and at bedtime.","other_id":"020022","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":0.5,"population":"","criteria":"\n        -  INCLUSION CRITERIA:\r\n\r\n        All ethnic groups.\r\n\r\n        Males and females.\r\n\r\n          -  Age greater than or equal to 6 months.\r\n\r\n          -  Clinically significant lipodystrophy, identified by the study physician during the\r\n             physical examination as an absence of fat outside the range of normal variation and/or\r\n             identified as a disfiguring factor by the patient.\r\n\r\n        Circulating leptin levels less than 12.0 ng/ml in females and less than 8.0 ng/ml in males\r\n        as measured by Linco assay on a specimen obtained after an overnight fast. In children ages\r\n        6 months 5 years, a circulating leptin level of less than 6 ng/mL will be used. Leptin\r\n        samples will be run through Millipore Laboratories, who use the Linco Assay, which has been\r\n        the assay previously used to measure leptin levels throughout this study period.\r\n\r\n        Presence of at least one of the following metabolic abnormalities:\r\n\r\n          1. Presence of diabetes as defined by the 2007 ADA criteria\r\n\r\n               1. Fasting plasma glucose greater than or equal to 126 mg/dL, or\r\n\r\n               2. 2 hour plasma glucose greater than or equal to 200 mg/dL following a 75 gram\r\n                  (1.75gm/kg) oral glucose load, or\r\n\r\n               3. Diabetic symptoms with a random plasma glucose greater than or equal to 200 mg/dl\r\n\r\n          2. Fasting insulin greater than 30 micro units/ml.\r\n\r\n          3. Fasting hypertriglyceridemia greater than 200 mg/dL or postprandially elevated\r\n             triglycerides greater than 500 mg/dL when fasting is clinically not indicated (e.g. in\r\n             infants)\r\n\r\n             -Persons with impaired decision-making capacity and who may be unable to provide\r\n             informed consent may participate in this study per the discretion of the Principal\r\n             Investigator.\r\n\r\n             EXCLUSION CRITERIA:\r\n\r\n             Pregnant women, women in their reproductive years who do not use an effective method\r\n             of birth control, and women currently nursing or lactating within 6 weeks of having\r\n             completed nursing.\r\n\r\n             Exclusions for underlying diseases likely to increase side effects or hinder objective\r\n             data collection:\r\n\r\n               -  Known infectious liver disease\r\n\r\n               -  Known HIV infection\r\n\r\n               -  Current alcohol or substance abuse\r\n\r\n               -  Psychiatric disorder impeding competence or compliance\r\n\r\n               -  Active tuberculosis\r\n\r\n               -  Use of anorexiogenic drugs\r\n\r\n               -  Other condition(s) which in the opinion of the clinical investigators would\r\n                  impede completion of the study\r\n\r\n               -  Subjects who have known hypersensitivity to E. Coli derived proteins.\r\n\r\n               -  Subjects with acquired lipodystrophy and a hematologic abnormality such as\r\n                  neutropenia and/or lymphadenopathy\r\n      ","sponsor":"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","sponsor_type":"NIH","conditions":"Lipodystrophy","interventions":[{"intervention_type":"Drug","name":"Drug: Metreleptin","description":"Drug treatment"}],"outcomes":[{"outcome_type":"primary","measure":"Percentage of Glycosylated Hemoglobin at Baseline, 6 Months, and 12 Months on Treatment With Metreleptin","time_frame":"Baseline, 6 months, 12 months","description":"Percentage of glycosylated hemoglobin at Baseline, 6 months, and 12 months on treatment with metreleptin"},{"outcome_type":"primary","measure":"Triglycerides at Baseline, 6 Months, and 12 Months on Treatment With Metreleptin","time_frame":"Baseline, 6 months, 12 months"}]}
{"nct_id":"NCT00028782","start_date":"2001-10-31","phase":"N/A","enrollment":80,"brief_title":"EF5 in Detecting Oxygen Level and Blood Vessels in Tumor Cells of Patients Undergoing Photodynamic Therapy for Intraperitoneal or Pleural Cancer","official_title":"The Detection of Tumor Hypoxia and Vascularity in Patients Undergoing Intraperitoneal Photodynamic Therapy","primary_completion_date":"2007-09-30","study_type":"Interventional","rec_status":"Terminated","last_update":"2013-01-16","description":"This phase II trial is studying how well EF5 works in detecting oxygen level and blood vessels in tumor cells of patients who are undergoing photodynamic therapy for intraperitoneal or pleural cancer. Diagnostic procedures using EF5 to detect oxygen level and blood vessels in tumor cells may help to improve the way photodynamic therapy is given","other_id":"NCI-2012-02438","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically confirmed intraperitoneal or pleural malignancy\r\n\r\n          -  Currently enrolled on 1 of 3 photodynamic therapy trials (UPCC-2997, UPCC-4997, or\r\n             UPCC-05503)\r\n\r\n               -  Plan to undergo surgery for treatment on one of these protocols\r\n\r\n          -  Patients with suspected recurrent disease undergoing surgery for diagnosis and\r\n             debulking allowed if frozen section shows malignant disease\r\n\r\n          -  No active extra-abdominal metastatic disease and/or intrahepatic involvement secondary\r\n             to metastatic carcinoma\r\n\r\n          -  No borderline tumors of low malignant potential\r\n\r\n          -  No abdominal disease that cannot be debulked to less than 5 mm residual disease in\r\n             maximal dimension\r\n\r\n          -  Performance status - ECOG 0-2\r\n\r\n          -  WBC at least 2,000/mm^3\r\n\r\n          -  Platelet count greater than 100,000/mm^3\r\n\r\n          -  Bilirubin less than 1.5 mg/dL\r\n\r\n          -  No severe liver disease\r\n\r\n          -  No cirrhosis\r\n\r\n          -  No grade III or IV elevations in liver function studies\r\n\r\n          -  Creatinine no greater than upper limit of normal\r\n\r\n          -  Creatinine clearance at least 60 mL/min\r\n\r\n          -  Not pregnant or nursing\r\n\r\n          -  Negative pregnancy test\r\n\r\n          -  Fertile patients must use effective contraception during and for 1 month after\r\n             completion of study treatment\r\n\r\n          -  Weight no more than 130 kg\r\n\r\n          -  HIV negative\r\n\r\n          -  Able to tolerate anesthesia or major surgery\r\n\r\n          -  No grade III or IV peripheral neuropathy\r\n\r\n          -  No regional enteritis or ulcerative colitis\r\n\r\n          -  No contraindication for anesthesia or major surgery\r\n\r\n          -  Prior combination chemotherapy for malignancy allowed\r\n\r\n          -  No concurrent chemotherapy except for recurrent or persistent disease\r\n\r\n          -  No concurrent radiotherapy except for recurrent or persistent disease\r\n\r\n          -  Prior surgery for malignancy allowed\r\n      ","sponsor":"National Cancer Institute (NCI)","sponsor_type":"NIH","conditions":"Advanced Malignant Mesothelioma|Localized Malignant Mesothelioma|Malignant Ascites|Primary Peritoneal Cavity Cancer|Recurrent Malignant Mesothelioma","interventions":[{"intervention_type":"Drug","name":"Drug: etanidazole","description":"Given IV"},{"intervention_type":"Procedure","name":"Procedure: therapeutic conventional surgery","description":"Undergo surgery"},{"intervention_type":"Other","name":"Other: laboratory biomarker analysis","description":"Correlative studies"}],"outcomes":[{"outcome_type":"primary","measure":"Level of hypoxia in tumor nodules","time_frame":"At the completion of surgery","description":"Exploratory techniques will be used to describe patterns of EF5 binding as well as MVD within and among patients."},{"outcome_type":"primary","measure":"Inter- and intra-patient variability of hypoxia by EF5 binding","time_frame":"At the completion of surgery","description":"Inter- and intra-subject variability can be estimated using summary statistics (standard deviations, or the range of data)."},{"outcome_type":"primary","measure":"Levels of microvascular density by PECAM/CD31 staining","time_frame":"At the completion of surgery","description":"Distributions of the four EF5 binding variables and MVD will be examined graphically we anticipate that certain variables may have a Poisson distribution."},{"outcome_type":"primary","measure":"Relationships among levels of hypoxia, microvascular density, and photosensitizer levels","time_frame":"At the completion of surgery"},{"outcome_type":"primary","measure":"Associations between hypoxia and photosensitizer levels in tumor nodules with clinical outcome periodically until disease recurrence","time_frame":"Not Provided"},{"outcome_type":"secondary","measure":"Toxicity of EF5 administration","time_frame":"Up to 45 days after EF5 infusion","description":"All observed toxicities will be graded, tabled for each stratum (IP study) and for the entire study and summarized by frequencies and percentages."}]}
{"nct_id":"NCT00028561","start_date":"2001-10-31","phase":"Phase 1","enrollment":45,"brief_title":"BMS-247550 Plus Carboplatin in Treating Patients With Recurrent or Refractory Solid Tumors","official_title":"A Phase I Study of Epothilone B Analog BMS 247550 in Combination With Carboplatin in Recurrent and/or Refractory Solid Tumors","primary_completion_date":"2007-02-28","study_type":"Interventional","rec_status":"Terminated","last_update":"2013-01-17","description":"This phase I trial is studying the side effects and best dose of BMS-247550 when given together with carboplatin in treating patients with recurrent or refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells","other_id":"NCI-2012-02726","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically or cytologically confirmed metastatic or unresectable solid tumor for\r\n             which standard curative or palliative measures do not exist or are no longer effective\r\n\r\n          -  Measurable or evaluable disease\r\n\r\n          -  Lesion accessible for core or excisional biopsy if being treated at the maximum\r\n             tolerated dose (MTD)\r\n\r\n               -  No biliary tract dilation if radiologically guided biopsy of the liver is planned\r\n\r\n               -  No requirement for core biopsy of lung lesion that is not pleural based\r\n\r\n               -  No requirement for laparotomy or thoracotomy solely for biopsy\r\n\r\n               -  No medical condition that would preclude biopsy\r\n\r\n          -  No known brain metastases\r\n\r\n          -  Performance status - ECOG 0-2\r\n\r\n          -  Performance status - ECOG 0-1 if being treated at the MTD\r\n\r\n          -  More than 3 months\r\n\r\n          -  Absolute neutrophil count at least 1,500/mm^3\r\n\r\n          -  Platelet count at least 100,000/mm^3\r\n\r\n          -  No prior bleeding disorder or unexplained bleeding if being treated at the MTD\r\n\r\n          -  Bilirubin no greater than 1.5 mg/dL\r\n\r\n          -  AST/ALT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver\r\n             metastases present)\r\n\r\n          -  PT/PTT normal\r\n\r\n          -  Creatinine no greater than 1.5 times ULN\r\n\r\n          -  Creatinine clearance at least 60 mL/min\r\n\r\n          -  No symptomatic congestive heart failure\r\n\r\n          -  No unstable angina pectoris\r\n\r\n          -  No cardiac arrhythmia\r\n\r\n          -  Not pregnant or nursing\r\n\r\n          -  Negative pregnancy test\r\n\r\n          -  Fertile patients must use effective contraception\r\n\r\n          -  No other concurrent uncontrolled illness that would preclude study participation\r\n\r\n          -  No ongoing or active infection\r\n\r\n          -  No grade 2 or greater neuropathy (sensory or motor)\r\n\r\n          -  No prior severe allergic reaction attributable to compounds containing Cremophor EL or\r\n             platinum agents\r\n\r\n          -  No psychiatric illness or social situation that would preclude study compliance\r\n\r\n          -  No medical condition that would preclude study if being treated at the MTD\r\n\r\n          -  At least 4 week since prior immunotherapy\r\n\r\n          -  At least 24 hours since prior growth factors\r\n\r\n          -  At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)\r\n\r\n          -  No more than 3 prior chemotherapy regimens\r\n\r\n          -  No prior epothilone agents\r\n\r\n          -  At least 1 week since prior hormonal therapy directed at malignancy\r\n\r\n          -  Concurrent hormone replacement therapy allowed\r\n\r\n          -  At least 4 weeks since prior wide-field radiotherapy involving 30% or more of bone\r\n             marrow\r\n\r\n          -  See Disease Characteristics\r\n\r\n          -  At least 4 weeks since prior investigational agents\r\n\r\n          -  No prior or concurrent St. John's Wort\r\n\r\n          -  No concurrent combination anti-retroviral therapy for HIV-positive patients\r\n\r\n          -  No other concurrent investigational agents\r\n\r\n          -  No concurrent heparin or other anticoagulants if being treated at the MTD\r\n\r\n          -  No concurrent inhibitors of cytochrome P450 3AP (CYP3A4)\r\n      ","sponsor":"National Cancer Institute (NCI)","sponsor_type":"NIH","conditions":"Unspecified Adult Solid Tumor, Protocol Specific","interventions":[{"intervention_type":"Drug","name":"Drug: ixabepilone","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: carboplatin","description":"Given IV"},{"intervention_type":"Other","name":"Other: laboratory biomarker analysis","description":"Correlative studies"},{"intervention_type":"Other","name":"Other: pharmacological study","description":"Correlative studies"}],"outcomes":[{"outcome_type":"primary","measure":"MTD of ixabepilone defined as the first dosage tier below the MAD in which =< 1/6 patients experiences a DLT","time_frame":"28 days"},{"outcome_type":"secondary","measure":"Pharmacokinetics of ixabepilone and carboplatin","time_frame":"Week 1"}]}
{"nct_id":"NCT00170573","start_date":"2001-10-31","phase":"Phase 2","enrollment":82,"brief_title":"Caelyx Biweekly in Heavily Pretreated Patients With Relapsed Ovarian Cancer","primary_completion_date":"2009-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-08-31","last_update":"2016-03-25","description":"Pegylated liposomal doxorubicin (PLD) formulation has been approved for the treatment of recurrent ovarian cancer (ROC). Toxic skin reactions were reported as being the dose-limiting toxicity and have an impact on patients' quality of life (QoL). The primary aim of this study was to optimise the toxicity profile by choosing a biweekly schedule of PLD Furthermore, QoL was investigated. Secondary objective of this study was to evaluate the response rates of this new regimen.","other_id":"32005000","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients  18 years of age\r\n\r\n          -  recurrent ovarian, peritoneal, or tubal cancer and prior treatment with platinum- and\r\n             paclitaxel were eligible to this trial.\r\n\r\n          -  Eastern Cooperative Oncology Group (ECOG) performance status less than 3.\r\n\r\n          -  renal function (serum creatinine 1.25 times the upper limit of normal, glomerular\r\n             filtration rate greater than 60 ml/min)\r\n\r\n          -  liver function (AST/ ALT three times the upper limit of normal, bilirubin\r\n             concentrations 1.25 the upper limit of normal)\r\n\r\n          -  bone marrow function (neutrophil count greater than 1.5 x 109/l, and a platelet count\r\n             greater than 100 x 109/l).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  patients with more than 4 chemotherapies in medical history\r\n\r\n          -  severe cardiac disease\r\n      ","sponsor":"North Eastern German Society of Gynaecological Oncology","sponsor_type":"Other","conditions":"Ovarian Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Caelyx","description":"Caelyx 40 mg/ m2biweekly"}],"outcomes":[{"outcome_type":"primary","measure":"Toxicity","time_frame":"Toxicity"},{"outcome_type":"secondary","measure":"Overall survival","time_frame":"Overall survival"}]}
{"nct_id":"NCT00065858","start_date":"2001-09-30","phase":"Phase 2/Phase 3","enrollment":975,"brief_title":"Effectiveness of BufferGel as a Vaginal Contraceptive","official_title":"A Randomized, Controlled Trial of the Efficacy, Safety, and Acceptability of BufferGel","study_type":"Interventional","rec_status":"Completed","completion_date":"2005-04-30","last_update":"2016-08-19","description":"BufferGel is a new contraceptive gel designed to be used with a diaphragm. In addition to preventing pregnancy, BufferGel may also prevent some types of sexually transmitted diseases (STDs). This study will compare BufferGel to Gynol II, a currently available contraceptive gel.","other_id":"CCN003","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"Female","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria\r\n\r\n          -  General good health\r\n\r\n          -  Sexually active, at risk for pregnancy, and desiring contraception\r\n\r\n          -  Low-risk for HIV or STD infection\r\n\r\n          -  Single sexual partner who is at low-risk for HIV or STD infection for 6 months prior\r\n             to study entry\r\n\r\n          -  Expect to have same sexual partner for duration of the study\r\n\r\n          -  Normal cyclic menses with a usual length of 21 to 35 days\r\n\r\n          -  Documented history of at least two spontaneous, normal menstrual cycles since\r\n             delivery, abortion, or after discontinuing hormonal contraception/hormonal therapy\r\n\r\n          -  Willing to accept a risk of pregnancy\r\n\r\n          -  Willing to engage in an average of 1 to 2 acts of heterosexual vaginal intercourse per\r\n             week for a period of 6 months\r\n\r\n          -  Willing to be fitted with a diaphragm and use the diaphragm with test product during\r\n             all acts of heterosexual vaginal intercourse for the duration of the study\r\n\r\n          -  Willing to only use the test product with diaphragm as the sole method of\r\n             contraception over the course of the study (with the exception of emergency\r\n             contraceptive pills when indicated)\r\n\r\n          -  Capable of using the product and diaphragm properly\r\n\r\n          -  Willing to keep a diary to record coital information, product use information,\r\n             information about the use of other vaginal products, and sign and symptom data for\r\n             self and partner\r\n\r\n          -  Agree not to participate in any other clinical trials during the course of the study\r\n\r\n          -  Written informed consent to participate in the trial\r\n\r\n        Participant's Sexual Partner Must Not Be/Have\r\n\r\n          -  Infertile\r\n\r\n          -  Treated for Chlamydia trachomatis or Neisseria gonorrhoeae in the 6 months prior to\r\n             study entry\r\n\r\n          -  HIV infected\r\n\r\n          -  More than one sexual partner in the 4 months prior to study entry\r\n\r\n          -  Engaged in homosexual intercourse\r\n\r\n          -  Shared injection drug needles in the 6 months prior to study entry\r\n\r\n          -  Allergy or sensitivity to spermicides or products containing Nonoxynol 9 or latex\r\n\r\n        Exclusion Criteria\r\n\r\n          -  Pregnant or desire to become pregnant during the course of the study\r\n\r\n          -  History of infertility or conditions that may lead to infertility\r\n\r\n          -  Allergy or sensitivity to spermicides or products containing Nonoxynol 9 or latex\r\n\r\n          -  History of toxic shock syndrome (TSS)\r\n\r\n          -  Two or more urinary tract infections (UTIs) in the 12 months prior to study entry\r\n\r\n          -  Current suspected or diagnosed urinary tract infection or vaginitis\r\n\r\n          -  Contraindications to pregnancy (medical condition or chronic use of medications\r\n             contraindicated for pregnancy)\r\n\r\n          -  Treated with antibiotics for pelvic inflammatory disease (PID) without a subsequent\r\n             intrauterine pregnancy\r\n\r\n          -  More than one sexual partner in the 4 months prior to study entry\r\n\r\n          -  Shared injection drug needles in the 6 months prior to study entry\r\n\r\n          -  HIV infected or suspected HIV infection\r\n\r\n          -  Genital herpes simplex virus (HSV) infection with the first occurrence (initial\r\n             episode) within 3 months prior to study entry or have clinical evidence of HSV on exam\r\n\r\n          -  Sexually transmitted diseases (STDs) in the 3 months prior to study entry\r\n\r\n          -  Lactating or breastfeeding\r\n\r\n          -  Abnormal vaginal bleeding or spotting in the month prior to study entry\r\n\r\n          -  Lower abdominal or pelvic pain in the month prior to study entry\r\n\r\n          -  Abnormal finding on pelvic examination which, in the view of the study investigator,\r\n             precludes participation in study\r\n\r\n          -  Vaginal or cervical irritation, including vaginal or cervical epithelial disruption,\r\n             ulceration, bleeding, petechiae, sloughing, or areas of obvious erythema\r\n\r\n          -  Vaginal or cervical biopsy or surgery in the 3 months prior to study entry\r\n\r\n          -  Vaginal or systemic antibiotics, antivirals, or antifungals in the 14 days prior to\r\n             study entry\r\n\r\n          -  Depo-Provera injection in the 10 months prior to study\r\n\r\n          -  Vaginal or cervical abnormality that would interfere with the proper placement and\r\n             retention of test product and diaphragm\r\n\r\n          -  Abnormal Pap smear in the 12 months prior to study entry\r\n\r\n          -  Consume (on average) greater than 2 to 3 alcoholic beverages per day\r\n\r\n          -  Drug abuse (recreational, prescription, or OTC) in the 12 months prior to study entry\r\n\r\n          -  Investigational drug or device use in the month prior to study entry\r\n\r\n          -  Previously participated in or completed this study\r\n      ","sponsor":"Health Decisions","sponsor_type":"Other","conditions":"Pregnancy","interventions":[{"intervention_type":"Drug","name":"Drug: BufferGel"}],"outcomes":{}}
{"nct_id":"NCT00505739","start_date":"2001-09-30","phase":"Phase 2","enrollment":13,"brief_title":"Mifepristone for Patients With Endometrial Cancer and LGESS","official_title":"Phase II Study of Mifepristone (RU-486) in the Treatment of PR Positive Advanced/Recurrent Endometrioid Adenocarcinoma and Low Grade Endometrial Stromal Sarcoma (LGESS)","primary_completion_date":"2007-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2008-05-31","last_update":"2012-07-30","description":"Primary Objectives: 1. To determine the antitumor activity of Mifepristone (RU-486) in patients with advanced or recurrent endometrioid adenocarcinoma or low grade endometrial stromal sarcoma (LGESS). 2. To evaluate the quantitative and qualitative toxicities of Mifepristone in this patient population. 3. To evaluate at a tissue level the effect of Mifepristone on estrogen and progesterone receptors post treatment and to evaluate other markers that may reflect effects of Mifepristone on cancer cell growth. 4. To evaluate the effect of the agent and dosing schedule on the patient's quality of life.","other_id":"ID01-212","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Histologic diagnosis of advanced/recurrent endometrioid adenocarcinoma or low grade\r\n             endometrial stromal sarcoma (LGESS) not amenable to curative surgery or radiotherapy.\r\n\r\n          2. Patients should have previously undergone radical surgery (minimum of total abdominal\r\n             hysterectomy and bilateral salpingoophorectomy) definitive radiation therapy, or not\r\n             be candidates for such procedures.\r\n\r\n          3. The primary (including archived specimens) or recurrent tumor must be PR positive.\r\n             Hormone receptor positivity is defined as PR positivity in >/+10% cells by\r\n             immunohistochemistry.\r\n\r\n          4. Prior radiotherapy must have been completed at least 2 weeks prior to the initiation\r\n             of Mifepristone and patients must have recovered from the acute side effects of such\r\n             treatment.\r\n\r\n          5. Performance status < Zubrod 2.\r\n\r\n          6. Estimated life expectancy of at least 12 weeks.\r\n\r\n          7. Prior chemotherapy for recurrent or metastatic endometrial cancer is permitted.\r\n\r\n          8. Patients must have measurable disease as defined by the presence of bidimensionally\r\n             measurable lesions with clearly defined margins on x-ray, scan (CT or MRI) or physical\r\n             exam.\r\n\r\n          9. Adequate bone marrow reserve: granulocyte count > 1.5 x 109/L, hemoglobin > 9 g/dL\r\n             (transfusion-independent) and platelets > 100,000 K/UL.\r\n\r\n         10. Adequate liver and renal function as defined as: total bilirubin value < 1.5 mg/dL;\r\n             SGPT < 2x the upper limit of normal or < 5x the upper limit of normal when liver\r\n             metastases are present; serum creatinine value of < 1.8 mg/dL. All qualifying\r\n             laboratory parameters must be determined within one week of first treatment.\r\n\r\n         11. Patient compliance and geographic proximity that allows adequate follow-up.\r\n\r\n         12. Signed informed consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Patients with serous or clear cell carcinomas of the endometrium.\r\n\r\n          2. Patients whose tumor is known to be PR negative.\r\n\r\n          3. Uncontrolled hypercalcemia.\r\n\r\n          4. Patients taking phenytoin, phenobarbital or carbamazepine.\r\n\r\n          5. Known predisposition to thromboembolic disorder, which in the investigator's judgment\r\n             would put the patient at unacceptable risk for thromboembolic complications.\r\n\r\n          6. Patients who have received treatment for brain metastases may be enrolled provided\r\n             they have remained stable for at least 6 months after surgery or radiation.\r\n\r\n          7. Women taking estrogen, progestin or antiprogestins. Patients taking these drugs must\r\n             have discontinued their use at least 3 weeks prior to beginning treatment with\r\n             Mifepristone.\r\n\r\n          8. History of other malignancy (except adequately treated non-melanomatous carcinoma of\r\n             the skin or cervical carcinoma in situ) unless in complete remission and off all\r\n             therapy for that disease for a minimum of 5 years.\r\n\r\n          9. Use of any chemotherapy or investigational agent within 3 weeks prior to taking study\r\n             drug.\r\n\r\n         10. Concurrent serious infection.\r\n\r\n         11. Patients with serious intercurrent medical illness.\r\n\r\n         12. Serious concomitant systemic disorders incompatible with the study (at the discretion\r\n             of the investigator).\r\n\r\n         13. Patients whom absorption of drugs is likely to be impaired due to either concomitant\r\n             medications or prior surgery.\r\n\r\n         14. Overt psychosis or mental disability or otherwise incompetent to give informed\r\n             consent.\r\n      ","sponsor":"M.D. Anderson Cancer Center","sponsor_type":"Other","conditions":"Endometrial Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: Mifepristone","description":"200 mg by mouth (PO) Daily x 4 Weeks"}],"outcomes":[{"outcome_type":"primary","measure":"Number of Patients with Overall Response","time_frame":"With each 4 week cycle, follow up 2 years","description":"Overall Response = Complete and Partial Responses"}]}
{"nct_id":"NCT00978718","start_date":"2001-08-31","phase":"Phase 3","enrollment":700,"brief_title":"Selenium in Preventing Prostate Cancer","official_title":"Phase III Trial of Selenium for Prostate Cancer Prevention","primary_completion_date":"2004-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2004-06-30","last_update":"2012-08-15","description":"RATIONALE: Selenium supplements may stop or delay the development of prostate cancer in patients at high risk of prostate cancer. It is not yet known which dose of selenium may be more effective in preventing prostate cancer. PURPOSE: This randomized phase III trial is studying how well selenium works in preventing prostate cancer.","other_id":"01-0506-01","allocation":"Randomized","primary_purpose":"Prevention","masking_description":"Double","sampling_method":"","gender":"Male","maximum_age":79,"population":"","criteria":"\n        DISEASE CHARACTERISTICS:\r\n\r\n          -  Clinical indicators consistent with the community standards of medical care that would\r\n             justify a biopsy of the prostate for the diagnosis of cancer, including  1 of the\r\n             following:\r\n\r\n               -  PSA level above the absolute value of 4 ng/mL or above a published age-ethnic\r\n                  adjusted PSA level appropriate for the community\r\n\r\n               -  Rising PSA that should represent a clinically significant PSA velocity (e.g., an\r\n                  estimated annual change in the PSA velocity  0.75 ng/mL)\r\n\r\n               -  Abnormal digital rectal examination of the prostate that identifies a clinically\r\n                  significant change in the prostate (e.g., a prostate nodule or a change in the\r\n                  firmness of the prostate)\r\n\r\n               -  Documentation of the clinical assessment that justified the prostate biopsy that\r\n                  allows classification of the patient to high-risk groups\r\n\r\n          -  Prostate biopsy negative for cancer within the past 12 months\r\n\r\n          -  Prostate biopsy negative for high-grade prostatic intraepithelial neoplasia (PIN)\r\n\r\n               -  PIN allowed provided it is grade 1\r\n\r\n        PATIENT CHARACTERISTICS:\r\n\r\n          -  Creatinine < 2 times upper limit of normal (ULN)\r\n\r\n          -  Bilirubin < 2 times ULN\r\n\r\n          -  SGOT and SGPT < 2 times ULN\r\n\r\n          -  Alkaline phosphatase < 2 times ULN\r\n\r\n          -  No history of a prior malignancy except for the following:\r\n\r\n               -  Adequately treated basal cell or squamous cell carcinoma\r\n\r\n               -  Adequately treated (i.e., complete surgical removal with negative margins) stage\r\n                  I cancer from which the patient is currently in complete remission\r\n\r\n               -  Any other cancer from which the patient has been disease-free for 5 years\r\n\r\n        PRIOR CONCURRENT THERAPY:\r\n\r\n          -  See Disease Characteristics\r\n\r\n          -  No prior systemic chemotherapy or radiotherapy\r\n\r\n          -  At least 90 days since prior and no other concurrent selenium > 55 g/day as a dietary\r\n             supplement (including multivitamin supplements)\r\n\r\n          -  More than 30 days since prior and no concurrent participation in any other clinical\r\n             trial involving a medical, surgical, nutritional, or life-style intervention (e.g.,\r\n             dietary modifications, exercise)\r\n      ","sponsor":"University of Arizona","sponsor_type":"Other","conditions":"Prostate Cancer","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: high-selenium baker's yeast","description":"Given orally"},{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: selenium","description":"Given orally"},{"intervention_type":"Other","name":"Other: placebo","description":"Given orally"}],"outcomes":[{"outcome_type":"primary","measure":"Incidence of biopsy-proven prostate cancer"},{"outcome_type":"secondary","measure":"Rate of rise in serum PSA levels"},{"outcome_type":"secondary","measure":"Evidence of prostate cancer progression as assessed by levels of the serum markers alkaline phosphatase and Chromogranin A"}]}
{"nct_id":"NCT00484627","start_date":"2001-08-31","phase":"Phase 2","enrollment":43,"brief_title":"Effects of Creatine and Resistance Exercise Training in People With HIV Infection","official_title":"Ergogenic Effects of Creatine Supplementation in HIV Infection","study_type":"Interventional","rec_status":"Completed","completion_date":"2003-10-31","last_update":"2007-06-11","description":"This study was designed determine whether use of creatine monohydrate, a dietary supplement, can increase skeletal muscle mass and strength and improve the response to progressive resistance exercise training in people with HIV infection.","other_id":"R01AT000491-01","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Clinically stable, sedentary HIV-positive adults who are on optimized antiretroviral\r\n             regimens and plan to remain so during the study.\r\n\r\n          -  Men and women on hormone replacement therapy and women using hormonal contraceptives\r\n             must have been on stable regimens for the preceding 6 months and plan to continue on\r\n             such treatment throughout the study period.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Serum creatinine > 1.5 mg/dl or clinical evidence of renal disease or prior kidney\r\n             transplant\r\n\r\n          -  Creatine kinase (CK) > 1.5 times the upper limit of normal (ULN)\r\n\r\n          -  Hemoglobin < 8.5 g/dl\r\n\r\n          -  AST, ALT, or LDH > 5 X ULN\r\n\r\n          -  Uncontrolled diarrhea (> 6 stools per day)\r\n\r\n          -  Impaired oral intake\r\n\r\n          -  Persistent nausea or vomiting\r\n\r\n          -  Untreated hypogonadism\r\n\r\n          -  Pharmacologic use of growth hormone, testosterone, oxandrolone, nandrolone decanoate,\r\n             oxymetholone, or other oral, injectable, or transdermal anabolic steroids,\r\n             androstenedione, or dehydroepiandrosterone (DHEA) within the preceding 6 months\r\n             (subjects with documented hypogonadism on stable testosterone replacement, defined as\r\n             a dose < 300 mg q2 weeks for the preceding 6 months, will be allowed to enroll)\r\n\r\n          -  Use of glucocorticoids, megestrol acetate, creatine monohydrate, cytokine inhibitors\r\n             (thalidomide, pentoxifylline, ketotifen), drugs known to adversely affect renal\r\n             function, cytokines, parenteral or tube feeding, or initiation of treatment for a\r\n             systemic infection within 30 days prior to enrollment\r\n\r\n          -  History of angina, coronary heart disease, or congestive heart failure\r\n\r\n          -  Current pregnancy or lactation or plans to become pregnant.\r\n\r\n          -  Because vegetarians are known to have lower intramuscular concentrations of creatine\r\n             and therefore may experience a much greater relative increase in muscle creatine\r\n             levels, we will exclude such individuals from this study.\r\n      ","sponsor":"National Center for Complementary and Integrative Health (NCCIH)","sponsor_type":"NIH","conditions":"HIV Infections","interventions":[{"intervention_type":"Procedure","name":"Procedure: Use of creatine monohydrate (a dietary supplement)"},{"intervention_type":"Behavioral","name":"Behavioral: Progressive resistance exercise training"}],"outcomes":[{"outcome_type":"primary","measure":"Muscle strength","time_frame":"14 weeks"},{"outcome_type":"secondary","measure":"Muscle size","time_frame":"14 weeks"},{"outcome_type":"secondary","measure":"Muscle energetics","time_frame":"14 weeks"},{"outcome_type":"secondary","measure":"Body composition","time_frame":"14 weeks"},{"outcome_type":"secondary","measure":"Biochemistries","time_frame":"14 weeks"},{"outcome_type":"secondary","measure":"Safety","time_frame":"Throughout the study"}]}
{"nct_id":"NCT00054951","start_date":"2001-06-30","phase":"Phase 1/Phase 2","enrollment":30,"brief_title":"Safety and Efficacy of Doxorubicin Adsorbed to Magnetic Beads","official_title":"A Phase I/II, Open Label, Multicenter, Single-Arm, Safety and Efficacy Study of Doxorubicin Hydrochloride Adsorbed to Magnetic Targeted Carriers (MTC-DOX) Administered by Intrahepatic Delivery (Via Hepatic Artery Catheterization) for the Treatment of Patients With Unresectable Hepatocellular Carcinoma.","study_type":"Interventional","rec_status":"Unknown status","last_update":"2005-06-24","description":"MTC-DOX is Doxorubicin or DOX, a chemotherapy drug, that is adsorbed, or made to \"stick,\" to magnetic beads (MTCs). MTCs are tiny, microscopic particles of iron and carbon. When DOX is added to MTCs, DOX attaches to the carbon part of the MTCs. MTC-DOX is directed to and deposited in the area of a tumor, where it is thought that it then \"leaks\" through the blood vessel walls. Once in the surrounding tissues, it is thought that Doxorubicin becomes \"free from\" the magnetic beads and will then be able to act against the tumor cells. The iron component of the particle has magnetic properties making it possible to direct MTC-DOX to specific tumor sites in the liver by placing a magnet on the body surface. It is hoped that MTC-DOX used with the magnet may target the chemotherapy directly to liver tumors and provide a treatment to patients with liver cancer. Patients enrolled in the study will be administered MTC-DOX through a hepatic artery catheter inserted under radiological guidance. During and following injection of the MTC-DOX, the drug will be localized to the hepatic tumor site by use of an external magnet. Dose may be divided in order to localize MTC-DOX to all lesions. The MTC-DOX intrahepatic infusions will be repeated every three weeks until tumor progression, complete remission, unacceptable toxicity, or a maximum of six treatment cycles. The purpose of this Phase 1/2 study is to evaluate time to disease progression following administration of MTC-DOX.","other_id":"MTC-DOX-006","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Patients may be enrolled into this protocol only if all of the following inclusion criteria\r\n        are met:\r\n\r\n          -  Patient has unresectable hepatocellular carcinoma diagnosed by CT scan and meets\r\n             criteria described in Section 23.\r\n\r\n          -  Total combined cross-sectional area of all hepatic tumors as determined by CT scan is\r\n             between 4 and 150 cm2.\r\n\r\n          -  The center of the tumor(s) mass must be less than or equal to 14 cm from the anterior\r\n             lateral abdominal wall as determined by cross-sectional imaging at baseline. This is\r\n             required for optimal placement of the magnet. If more than one tumor mass is present,\r\n             all of the tumor masses must meet this criterion.\r\n\r\n          -  Patient is ambulatory with a Karnofsky performance status score greater than or equal\r\n             to 60 and an estimated life expectancy of greater than or equal to 3 months.\r\n\r\n          -  Patient is between 18 and 80 years old.\r\n\r\n          -  Patient is judged by the investigator to have the initiative and means to be compliant\r\n             with the protocol and be within geographical proximity to allow follow-up.\r\n\r\n          -  Patient or legal representative has the ability to give informed written consent prior\r\n             to initiation of therapy.\r\n\r\n          -  If patient is female and of childbearing potential, she must have a negative b-HCG\r\n             prior to receiving treatment.\r\n\r\n          -  Patient must agree to use an effective method of contraception (e.g., birth control\r\n             pills, condoms, intrauterine device, diaphragm, Norplant, Depo-Provera).\r\n\r\n        Patients will be excluded from enrollment if any of the following apply:\r\n\r\n          -  Patient has a history of cancer other than hepatocellular (excluding resected basal\r\n             cell carcinoma; or curatively resected stage 1 or less cervical cancer if disease free\r\n             for 5 years or more).\r\n\r\n          -  Patient has had prior radiation therapy within the last 6 months or chemotherapy\r\n             within the last 4 weeks.\r\n\r\n          -  Patients with diffuse hepatocellular carcinoma or disease that precludes delivery of\r\n             the drug to the tumor via a vessel that feeds the tumor.\r\n\r\n          -  Patient has another active medical condition(s) or organ disease(s) that may either\r\n             compromise patient safety or interfere with the safety and/or outcome (e.g., survival)\r\n             evaluation of the study drugs. While this exclusion is not limited to the following\r\n             abnormalities, if any of the following laboratory abnormalities are present, the\r\n             patient should be excluded:\r\n\r\n        WBC < 3,500/uL Platelets < 40,000/ul Hemoglobin < 9.5 gm/dL Total bilirubin > 2.5 mg/dL ALT\r\n        or AST > or equal to 5 x upper limit of normal Serum Creatinine > 2.0 mg/dL INR > or equal\r\n        to 2.0\r\n\r\n          -  Patient has cardiac dysfunction with a left ventricular ejection fraction < 40%.\r\n\r\n          -  Patient or physician plans concomitant chemotherapy, radiation therapy, hormonal\r\n             and/or biological treatment for cancer including immunotherapy (excluding megace, oral\r\n             contraceptives or post menopausal estrogen replacement therapy) while on study.\r\n\r\n          -  Patients with an indwelling cardiac pacemaker, cerebral aneurysm clips, or any other\r\n             indwelling device or appliance that could be adversely affected by the use of the\r\n             external magnet.\r\n\r\n          -  Patients with documented evidence of hemachromatosis or hemosiderosis.\r\n\r\n          -  Patients with CT or Ultrasound evidence of main or first branch portal vein invasion\r\n             or thrombosis.\r\n\r\n          -  Prior orthotopic hepatic transplant.\r\n\r\n          -  Patient has received previous treatment with doxorubicin, idarubicin, and/or other\r\n             anthracyclines or anthracenes.\r\n\r\n          -  Patient has a known allergy to doxorubicin, MTC-DOX or any of their components.\r\n\r\n          -  Patient has been treated with any investigational drug, investigational biologic, or\r\n             investigational therapeutic device within 30 days of initiating study treatment.\r\n      ","sponsor":"FeRx","sponsor_type":"Industry","conditions":"Hepatocellular Carcinoma","interventions":[{"intervention_type":"Drug","name":"Drug: MTC-DOX for Injection"}],"outcomes":{}}
{"nct_id":"NCT00037960","start_date":"2001-06-30","phase":"Phase 2","brief_title":"Automated Constraint-Induced Therapy for Restoring Movement After Stroke","official_title":"Automated Constraint-Induced Therapy for Restoring Movement After Stroke","study_type":"Interventional","rec_status":"Completed","completion_date":"2004-06-30","last_update":"2009-01-21","description":"We propose to develop and evaluate a workstation that significantly enhances the application of Constraint-Induced (CI) Therapy by automating and instrumenting several of the tasks currently used in the shaping training. The motivation for development of such a device is as follows: 1) Patients could receive CI therapy at home without the need for constant supervision from a therapist. Many veterans do not have the resources to travel to their local VAMC for the two or three week period required for the treatment. A home-based device would expand the pool of veterans who could receive CI therapy. 2) For subjects who were able to receive CI therapy in the clinic, this device would facilitate an effective post-treatment home-practice program. 3) Currently, patients are treated on a one-on-one basis in the clinic. This device could allow one therapist to treat 3 or 4 patients at one time, thereby substantially reducing the cost of the therapy. 4) This workstation would provide clear and comprehensive quantification of the progress of the treatment. This could indicate on which tasks the patient was progressing most and least rapidly, and would therefore enable effective modifications of the treatment plan while treatment was in progress. The hypothesis is that the positive outcomes of CI therapy can be achieved, and possibly enhanced, if the shaping training component is performed in a workstation that guides, motivates and records exercise of the more-affected limb. In the first 18 months, the workstation will be designed and fabricated. To expedite the design, we will rely on simple modifications to \"off the shelf\" components. In the last 18 months, a controlled, randomized, clinical trial will compare the effectiveness of automated CI therapy programs with standard CI therapy. The standard CI therapy group would receive shaping training in a clinical setting, one-on-one with a therapist. The clinic-based automated CI therapy group would perform the shaping training in the workstation, in a clinical setting and with minimal supervision. The home-based automated CI therapy group would perform the shaping training at home in the workstation, and with no direct supervision. All other aspects of the three treatment programs will be identical. At the end of this 3-year project, a device will have been designed, built and evaluated that could significantly enhance the application of CI therapy for chronic stroke patients.","other_id":"B2480T","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Stroke patients\r\n      ","sponsor":"US Department of Veterans Affairs","sponsor_type":"U.S. Fed","conditions":"Cerebrovascular Accident","interventions":[{"intervention_type":"Procedure","name":"Procedure: Constrained Induced Therapy"}],"outcomes":{}}
{"nct_id":"NCT00037687","start_date":"2001-04-30","phase":"Phase 3","enrollment":2500,"brief_title":"Safety and Efficacy of Recombinant Human Platelet-Activating Factor Acetylhydrolase for the Treatment of Severe Sepsis","official_title":"A Phase 3 Study to Demonstrate the Safety and Efficacy of Recombinant Platelet-Activating Factor Acetylhydrolase (rPAF-AH, Pafase) for Reducing 28 Day All Cause Mortality in Patients With Severe Sepsis","study_type":"Interventional","rec_status":"Terminated","completion_date":"2004-12-31","last_update":"2005-06-24","description":"The objective of this study is to demonstrate that rPAF-AH is safe and reduces 28 day all cause mortality in patients with severe sepsis.","other_id":"BAR03","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion criteria\r\n\r\n          -  Clinical diagnosis of severe sepsis\r\n\r\n          -  At least 18 years old\r\n\r\n          -  Patient or legally authorized representative able to provide informed consent\r\n\r\n        Exclusion criteria\r\n\r\n          -  Severe lung injury (acute respiratory distress syndrome)\r\n\r\n          -  Immunocompromised\r\n\r\n          -  Severe liver disease\r\n\r\n          -  Inflammation of the pancreas, organ rejection, or burns to more than 30% of body\r\n\r\n          -  Enrolled in another clinical trial\r\n\r\n          -  Already participated in this or other rPAF-AH study\r\n\r\n          -  There is not a commitment to aggressive treatment\r\n\r\n          -  Has a disease with life expectancy less than 6 months\r\n      ","sponsor":"ICOS Corporation","sponsor_type":"Industry","conditions":"Sepsis","interventions":[{"intervention_type":"Drug","name":"Drug: rPAF-AH"}],"outcomes":{}}
{"nct_id":"NCT00006462","start_date":"2001-04-30","phase":"Phase 2","enrollment":32,"brief_title":"Gemcitabine in Treating Children With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia","official_title":"A Phase II Study of Gemcitabine (NSC #613327) in Children With Relapsed Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia","primary_completion_date":"2003-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2006-09-30","last_update":"2014-02-20","description":"RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating children who have relapsed or refractory acute lymphoblastic leukemia or acute myelogenous leukemia.","other_id":"ADVL0022","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","maximum_age":21,"population":"","criteria":"\n        DISEASE CHARACTERISTICS:\r\n\r\n          -  Diagnosis of relapsed acute lymphoblastic leukemia or acute myelogenous leukemia\r\n\r\n               -  M3 marrow (at least 25% blasts in bone marrow aspirate)\r\n\r\n               -  Refractory to conventional therapy\r\n\r\n        PATIENT CHARACTERISTICS:\r\n\r\n        Age:\r\n\r\n          -  21 and under at diagnosis\r\n\r\n        Performance status:\r\n\r\n          -  ECOG 0-2 OR\r\n\r\n          -  Zubrod 0-2\r\n\r\n        Life expectancy:\r\n\r\n          -  At least 2 months\r\n\r\n        Hematopoietic:\r\n\r\n          -  Not specified\r\n\r\n        Hepatic:\r\n\r\n          -  Bilirubin normal\r\n\r\n          -  SGOT or SGPT no greater than 2.5 times upper limit of normal\r\n\r\n        Renal:\r\n\r\n          -  Creatinine normal OR\r\n\r\n          -  Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min\r\n\r\n        Other:\r\n\r\n          -  Not pregnant or nursing\r\n\r\n          -  Negative pregnancy test\r\n\r\n          -  Fertile patients must use effective contraception\r\n\r\n        PRIOR CONCURRENT THERAPY:\r\n\r\n        Biologic therapy:\r\n\r\n          -  No concurrent immunomodulating agents\r\n\r\n        Chemotherapy:\r\n\r\n          -  At least 2 weeks since prior chemotherapy\r\n\r\n          -  No other concurrent chemotherapy for cancer\r\n\r\n        Endocrine therapy:\r\n\r\n          -  No concurrent corticosteroids except for treatment of adrenal crises with suppressed\r\n             pituitary/adrenal response\r\n\r\n          -  Concurrent low-dose hydrocortisone (less than 100 mg/m2) allowed for allergic\r\n             reactions to amphotericin or transfusions\r\n\r\n        Radiotherapy:\r\n\r\n          -  Concurrent radiotherapy to localized painful lesions allowed\r\n\r\n        Surgery:\r\n\r\n          -  Not specified\r\n\r\n        Other:\r\n\r\n          -  Recovered from any prior therapy\r\n      ","sponsor":"Children's Oncology Group","sponsor_type":"Other","conditions":"Leukemia","interventions":[{"intervention_type":"Drug","name":"Drug: gemcitabine hydrochloride"}],"outcomes":[{"outcome_type":"primary","measure":"Determine the response rate to Gemcitabine","description":"To determine the response rate to Gemcitabine administered as 10 mg/m2/min x 360 minutes weekly for 3 weeks in patients with relapsed acute lymphoblastic and acute myelogenous leukemia."}]}
{"nct_id":"NCT00017472","start_date":"2001-04-30","phase":"Phase 1","enrollment":35,"brief_title":"Monoclonal Antibody Therapy in Treating Patients With Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma, Acute Lymphoblastic Leukemia, or Acute Myeloid Leukemia","official_title":"Phase I Study of Thrice Weekly Hu1D10*in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Acute Leukemia","primary_completion_date":"2006-04-30","study_type":"Interventional","rec_status":"Completed","last_update":"2013-06-04","description":"Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have chronic lymphocytic leukemia, lymphocytic lymphoma, acute lymphoblastic leukemia, or acute myeloid leukemia.","other_id":"NCI-2012-01405","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  One of the following diagnoses:\r\n\r\n               -  Histologically confirmed chronic lymphocytic leukemia (CLL) or non-contiguous\r\n                  stage II or stage III-IV small lymphocytic lymphoma (SLL)\r\n\r\n                    -  Previously treated with at least 1 form of chemotherapy or immunotherapy\r\n\r\n               -  Histologically confirmed acute lymphoblastic leukemia (enrolled after the maximum\r\n                  tolerated dose (MTD) is determined)\r\n\r\n                    -  Must have failed 1 prior therapy\r\n\r\n                    -  Ineligible for allogeneic stem cell transplantation\r\n\r\n               -  Histologically confirmed acute myeloid leukemia (enrolled after the MTD is\r\n                  determined)\r\n\r\n                    -  Primary refractory or relapsed (within the past year) disease\r\n\r\n                    -  Ineligible for potential curative therapy\r\n\r\n          -  Express Hu1D10 antigen\r\n\r\n               -  Greater than 2 times the mean fluorescence intensity of the control by flow\r\n                  cytometry (blood or bone marrow cells) OR\r\n\r\n               -  Positive by immunohistochemical staining (lymph node)\r\n\r\n          -  Presenting with one of the following indications for treatment unless early bone\r\n             marrow transplantation is planned (CLL or SLL patients only):\r\n\r\n               -  Disease-related progressive symptoms\r\n\r\n               -  Progressively worsening anemia or thrombocytopenia\r\n\r\n               -  Progressively worsening lymphadenopathy\r\n\r\n               -  Massive splenomegaly or hypersplenism\r\n\r\n               -  Hyperlymphocytosis (WBC greater than 200,000/mm3) or lymphocyte doubling time\r\n                  less than 12 months\r\n\r\n               -  Marrow failure secondary to marrow infiltration by leukemia or lymphoma\r\n\r\n          -  Performance status - ECOG 0-2\r\n\r\n          -  At least 2 years\r\n\r\n          -  See Disease Characteristics\r\n\r\n          -  Platelet count at least 50,000/mm^3 (without transfusion)\r\n\r\n          -  Bilirubin no greater than 3 mg/dL (unless elevated secondary to tumor)\r\n\r\n          -  Creatinine no greater than 2.0 mg/dL\r\n\r\n          -  No prior decompensated congestive heart failure, unstable angina, or myocardial\r\n             infarction within the past 6 months not corrected by percutaneous transluminal\r\n             coronary angioplasty or surgery\r\n\r\n          -  No active infection requiring oral or IV antibiotics\r\n\r\n          -  No other malignancy that would limit life expectancy\r\n\r\n          -  HIV negative\r\n\r\n          -  Not pregnant or nursing\r\n\r\n          -  Negative pregnancy test\r\n\r\n          -  Fertile patients must use effective contraception during and for 3 months after study\r\n\r\n          -  See Disease Characteristics\r\n\r\n          -  At least 1 month since prior rituximab or alemtuzumab (unless CD20 or CD52 antigen is\r\n             expressed on tumor cells)\r\n\r\n          -  No prior monoclonal antibody Hu1D10\r\n\r\n          -  See Disease Characteristics\r\n      ","sponsor":"National Cancer Institute (NCI)","sponsor_type":"NIH","conditions":"Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue|Nodal Marginal Zone B-cell Lymphoma|Noncontiguous Stage II Marginal Zone Lymphoma|Noncontiguous Stage II Small Lymphocytic Lymphoma|Recurrent Adult Acute Lymphoblastic Leukemia|Recurrent Adult Acute Myeloid Leukemia|Recurrent Marginal Zone Lymphoma|Recurrent Small Lymphocytic Lymphoma|Refractory Chronic Lymphocytic Leukemia|Splenic Marginal Zone Lymphoma|Stage III Marginal Zone Lymphoma|Stage III Small Lymphocytic Lymphoma|Stage IV Marginal Zone Lymphoma|Stage IV Small Lymphocytic Lymphoma","interventions":[{"intervention_type":"Biological","name":"Biological: apolizumab","description":"Given IV"},{"intervention_type":"Other","name":"Other: laboratory biomarker analysis","description":"Correlative studies"},{"intervention_type":"Other","name":"Other: pharmacological study","description":"Correlative studies"}],"outcomes":[{"outcome_type":"secondary","measure":"Cytokine release","time_frame":"Up to 1 year","description":"Descriptive data will be computed and compared using analysis of variance and non-parametric rank equivalents for continuous data and chi-square or Fisher's exact test for discrete data. Nevertheless, low statistical power will greatly limit these analyses."},{"outcome_type":"secondary","measure":"Caspase activation","time_frame":"Up to 1 year","description":"Descriptive data will be computed and compared using analysis of variance and non-parametric rank equivalents for continuous data and chi-square or Fisher's exact test for discrete data. Nevertheless, low statistical power will greatly limit these analyses."},{"outcome_type":"secondary","measure":"Signaling and expression of apoptosis protein","time_frame":"Up to 1 year","description":"Descriptive data will be computed and compared using analysis of variance and non-parametric rank equivalents for continuous data and chi-square or Fisher's exact test for discrete data. Nevertheless, low statistical power will greatly limit these analyses."},{"outcome_type":"primary","measure":"MTD defined as the dose level below which two or more of six patients experience a DLT assessed using NCI CTC version 2.0","time_frame":"Up to 30 days"},{"outcome_type":"secondary","measure":"Evaluation of the degree of apoptosis induced by ex vivo incubation of human CLL cells with Hu1D10","time_frame":"Up to 1 year","description":"Descriptive data will be computed and compared using analysis of variance and non-parametric rank equivalents for continuous data and chi-square or Fisher's exact test for discrete data. Nevertheless, low statistical power will greatly limit these analyses."}]}
{"nct_id":"NCT00017251","start_date":"2001-04-30","phase":"Phase 1","enrollment":12,"brief_title":"Combination Chemotherapy Plus Oblimersen in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer","official_title":"A Phase I Study Of Genasense, A Bcl-2 Antisense Oligonucleotide, Combined With Carboplatin And Etoposide In Patients With Small Cell Lung Cancer","primary_completion_date":"2004-01-31","study_type":"Interventional","rec_status":"Completed","last_update":"2013-01-24","description":"Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may make tumor cells more sensitive to chemotherapy drugs. Phase I trial to study the effectiveness of combination chemotherapy and oblimersen in treating patients who have extensive-stage small cell lung cancer","other_id":"NCI-2012-02387","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically or cytologically confirmed extensive stage small cell lungcancer\r\n\r\n          -  No active CNS disease\r\n\r\n               -  CNS metastasis allowed provided patient completed 1 course of CNS radiotherapy\r\n\r\n          -  Performance status - ECOG 0-2\r\n\r\n          -  Performance status - Karnofsky 60-100%\r\n\r\n          -  More than 2 months\r\n\r\n          -  WBC at least 3,000/mm^3\r\n\r\n          -  Absolute neutrophil count at least 1,500/mm^3\r\n\r\n          -  Platelet count at least 100,000/mm^3\r\n\r\n          -  Bilirubin normal\r\n\r\n          -  AST and ALT no greater than 2.5 times upper limit of normal (ULN)\r\n\r\n          -  PT and PTT no greater than 1.5 times ULN\r\n\r\n          -  Creatinine normal\r\n\r\n          -  Creatinine clearance at least 60 mL/min\r\n\r\n          -  No symptomatic congestive heart failure\r\n\r\n          -  No unstable angina pectoris\r\n\r\n          -  No cardiac arrhythmia\r\n\r\n          -  Not pregnant or nursing\r\n\r\n          -  Negative pregnancy test\r\n\r\n          -  Fertile patients must use effective contraception\r\n\r\n          -  No prior allergic reactions to compounds of similar chemical or biologic composition\r\n             to study agents\r\n\r\n          -  No other uncontrolled concurrent illness\r\n\r\n          -  No ongoing or active infection\r\n\r\n          -  No psychiatric illness or social situation that would preclude study compliance\r\n\r\n          -  See Disease Characteristics\r\n\r\n          -  At least 1 week since prior CNS radiotherapy and recovered\r\n\r\n          -  No prior radiotherapy to more than 25% of skeleton\r\n\r\n          -  No other prior anticancer therapy\r\n\r\n          -  No other concurrent investigational agents\r\n\r\n          -  No other concurrent anticancer therapy\r\n\r\n          -  No concurrent anticoagulation therapy\r\n\r\n          -  No concurrent combination antiretroviral therapy for HIV-positive patients\r\n      ","sponsor":"National Cancer Institute (NCI)","sponsor_type":"NIH","conditions":"Extensive Stage Small Cell Lung Cancer","interventions":[{"intervention_type":"Biological","name":"Biological: oblimersen sodium","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: carboplatin","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: etoposide","description":"Given IV"},{"intervention_type":"Other","name":"Other: pharmacological study","description":"Correlative studies"},{"intervention_type":"Other","name":"Other: laboratory biomarker analysis","description":"Correlative studies"}],"outcomes":[{"outcome_type":"primary","measure":"Feasibility and toxicity of the regimen monitored using the Common Toxicity Criteria Version 2.0","time_frame":"Up to 3 years","description":"Data will be summarized separately for each dose level, by severity, and type of toxicity."},{"outcome_type":"primary","measure":"Maximally tolerated dose of oblimersen sodium","time_frame":"8 days"},{"outcome_type":"secondary","measure":"Potential antitumor activity (responses to therapy)","time_frame":"Up to 3 years","description":"Will be analyzed using simple descriptive statistics only."},{"outcome_type":"secondary","measure":"Whether concomitant carboplatin and etoposide administration alters oblimersen sodium steady state level","time_frame":"Day 6 and 8","description":"Will be analyzed using a paired t-test. If there are outliers or the distribution of changes in oblimersen sodium levels appears to be highly non-normal, the data will be analyzed using the Wilcoxon singed-rank test."}]}
{"nct_id":"NCT00295152","start_date":"2001-04-30","phase":"N/A","enrollment":135,"brief_title":"Effects of Community Occupational Therapy in Older Patients With Dementia and Their Caregivers.","official_title":"Effects of Community Occupational Therapy on the Daily Performance of Older Patients With Mild to Moderate Dementia and on the Sense of Competence of Their Primary Caregivers.","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2005-02-28","last_update":"2011-11-17","description":"The purpose of this study is to determine the effects of community occupational therapy in older patients with mild ot moderate dementia and their primary caregivers.","other_id":"EDO project","allocation":"Randomized","intervention_model":"Factorial Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  aged 65 years or older\r\n\r\n          -  mild to moderate dementia (MMSE 10-24)\r\n\r\n          -  living in the community at maximum of 50 kilometers from the Memory Clinic\r\n\r\n          -  having an informal primary caregiver who was involved in the care for the patient at\r\n             least once a week\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  depression: score > 12 on the Geriatric Depression Scale\r\n\r\n          -  severe behavioral or psychological symptoms in dementia (BPSD) judged by a\r\n             geriatrician\r\n\r\n          -  severe illnesses, judged by a geriatrician\r\n\r\n          -  no OT goals, determined by the researcher or research assistant\r\n\r\n          -  caregivers having severe illnesses\r\n      ","sponsor":"Radboud University","sponsor_type":"Other","conditions":"Community Occupational Therapy|Dementia Patients|Primary Caregivers of Dementia Patients","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: community occupational therapy in dementia"}],"outcomes":[{"outcome_type":"secondary","measure":"1. mastery skills scored on the Mastery Scale"},{"outcome_type":"secondary","measure":"2. general health scores on the GHQ-12"},{"outcome_type":"secondary","measure":"3. quality of life scores on the DQOL"},{"outcome_type":"primary","measure":"1.process skills scores of the patients on the Assessment of Motor and Process Skills (AMPS);"},{"outcome_type":"primary","measure":"2. performance scores in daily activities of the patients on the Interview of Deterioration in Daily Activities in Dementia (IDDD);"},{"outcome_type":"primary","measure":"3. Sense of competence scores of the primary caregivers on the Sense of Competence Questionnaire (SCQ)."},{"outcome_type":"secondary","measure":"Patients:"},{"outcome_type":"secondary","measure":"1. motor skills scores on the AMPS"},{"outcome_type":"secondary","measure":"2. initiative in performing daily activities on the IDDD"},{"outcome_type":"secondary","measure":"3. general health scores on the General Health Questionnaire (GHQ-12)"},{"outcome_type":"secondary","measure":"4.Quality of life scored on the Dementia Quality of Life Instrument (DQOL)"},{"outcome_type":"secondary","measure":"5. Self-perception scores in occupational performance and satisfaction scores with this performance, scored on the Canadian Occupational Performance Measurement (COPM)"},{"outcome_type":"secondary","measure":"6. Mood/depression scored on the Cornell Depression Scale (CDS)"},{"outcome_type":"secondary","measure":"Caregiver:"},{"outcome_type":"secondary","measure":"4. self-perception scores in occupational performance and satisfaction scores on the COPM"},{"outcome_type":"secondary","measure":"5. mood/depression scores on the Center for Epidemiologic Studies Depression Scales (Ces-D)"},{"outcome_type":"secondary","measure":"6. Copings skills scores on the JCS"}]}
{"nct_id":"NCT00319540","start_date":"2001-03-31","phase":"Phase 2","enrollment":155,"brief_title":"RCT of Psychoeducational Program of Depression","official_title":"A Randomized Controlled Trial of a Psychoeducational Group Program for Unipolar Depression in Adults in Norway","study_type":"Interventional","rec_status":"Completed","completion_date":"2002-03-31","last_update":"2006-04-27","description":"The purpose of the study is to test the efficacy of a psychoeducational group program on unipolar depression","other_id":"2906","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:Unipolar depression -\r\n\r\n        Exclusion Criteria:Psychosis, other psychiatric disorders, subclinical depression, suicidal\r\n        ideation, learning disabilities\r\n\r\n        -\r\n      ","sponsor":"Norwegian Institute of Public Health","sponsor_type":"Other","conditions":"Unipolar Depression","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Control with depression course (CWD)"}],"outcomes":[{"outcome_type":"primary","measure":"BeckDepression Inventory : A questionnaire with 23 items to measure symptoms of depression"}]}
{"nct_id":"NCT01977261","start_date":"2001-01-31","phase":"N/A","enrollment":92,"brief_title":"High Tibial Osteotomy for Osteoarthritis of the Knee","official_title":"High Tibial Osteotomy for Osteoarthritis of the Knee: a Randomised Controlled Trial","primary_completion_date":"2004-04-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2004-04-30","last_update":"2013-11-06","description":"A prospective, randomised, controlled trial compared two different techniques of high tibial osteotomy with a lateral closing wedge or a medial opening wedge, stabilised by a Puddu plate. The clinical outcome and radiological results were examined at one year.","other_id":"2001-HTO","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Radiological OA, medial joint pain and varus malalignment\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Symptomatic OA of the lateral compartment, rheumatoid arthritis, ROM <100, collateral\r\n             ligament laxity, history of fracture of previous open operation of the lower limb and\r\n             a flexion contracture > 10 degrees.\r\n      ","sponsor":"Erasmus Medical Center","sponsor_type":"Other","conditions":"Osteoarthritis","interventions":[{"intervention_type":"Procedure","name":"Procedure: Opening-wedge HTO","description":"Opening-wedge high tibial osteotomy fixated with a Puddu plate"},{"intervention_type":"Procedure","name":"Procedure: Closing-wedge HTO","description":"Closing-wedge high tibial osteotomy fixated with two staples"}],"outcomes":[{"outcome_type":"primary","measure":"The achievement of an overcorrection of valgus of 4°.","time_frame":"one year","description":"The achieved correction will be determined on a whole leg radiograph."},{"outcome_type":"secondary","measure":"Severity of pain","time_frame":"one year","description":"Severity of pain will be measured with the visual analogue scale"},{"outcome_type":"secondary","measure":"Knee function","time_frame":"one year","description":"Knee function will be measured with the Hospital for Special Surgery score"},{"outcome_type":"secondary","measure":"Walking distance","time_frame":"one year"},{"outcome_type":"other","measure":"Number of participants with adverse events","time_frame":"one year","description":"Number of participants with adverse events; infection, loss of correction, hardware removal, implant failure, pseudoarthrosis, peroneal nerve injury."}]}
{"nct_id":"NCT00007124","start_date":"2000-12-31","enrollment":15,"brief_title":"Ketogenic Diet in Lafora Disease","official_title":"A Trial of Ketogenic Diet in Lafora Disease","study_type":"Observational","rec_status":"Completed","completion_date":"2002-11-30","last_update":"2008-03-04","description":"This study will examine the effect of a restricted-carbohydrate diet (ketogenic diet) on Lafora disease-a severe neurological disease in which brain cells die because of abnormal accumulation of glucose (a type of sugar). Patients with Lafora disease have rapid neurological deterioration with myoclonus (brief muscle jerks), seizures and mental decline. At present there is no treatment to halt disease progression. Patients 10 years of age and older with relatively advanced Lafora disease may be eligible for this study. Participants will be admitted to the Clinical Center for the first 4 weeks of this 6-month study for baseline testing and to start the ketogenic diet. They will have a complete medical history and physical examination, plus a detailed neurological examination and blood and urine tests. Procedures include: - Magnetic resonance imaging (MRI) brain scans to provide information about brain chemistry - Lumbar puncture (spinal tap) to analyze chemicals in cerebrospinal fluid - Metabolic and endocrinological tests, including a glucose tolerance test, to evaluate the body's response to a large intake of oral glucose - Standard neuropsychological tests - Magnetic resonance spectroscopy of the brain and muscle - Electroencephalography (EEG) to measure brain wave activity - Electromyography (EMG) to measure muscle activity - Evoked potentials (SEP and VEP) to study brain responses to mild electric or visual stimulation. Transcranial magnetic stimulation (magnetic stimulation of the brain) may also be done to study the function of the brain cortex (outer nervous tissue of the brain) and the effects of treatment on brain excitability. The ketogenic diet will begin after the tests are completed. The diet provides mainly fats to fuel the body, plus the recommended amount of protein and minimum carbohydrate. Vitamin and mineral supplements are provided to meet daily requirements. After 2 weeks on the diet, the patient will be discharged from the hospital and seen daily as an outpatient for another 1 to 2 weeks. During this time the patient or caregiver is trained in preparing the ketogenic diet, and then the patient is discharged to home. Throughout the study, disease symptoms will be assessed using standardized rating scales. Blood and urine tests will be done as needed, as will follow-up brain imaging, neuropsychological and neurophysiological evaluations. A skin and/or muscle biopsy may be done at the first clinic visit to grow skin cells in culture and to analyze the skin and muscle under a microscope. The biopsy area is numbed with an anesthetic and a small piece of tissue is removed either with a needle, an instrument similar to a cookie-cutter or a knife. The skin cells may be used for metabolic studies and to obtain DNA for genetic testing. At the end of the study, patients who responded well to the treatment with no significant adverse side effects may continue the diet for another 12 months. They will be followed at 3-month intervals to monitor side effects and treatment response.","other_id":"010042","sampling_method":"","gender":"All","population":"","criteria":"\n        Males and females older than 10 years will be eligible for this study. Younger children may\r\n        not be sufficiently cooperative.\r\n\r\n        Women of child-bearing age must be using adequate contraceptive method for at least one\r\n        month prior to and during participation in the study.\r\n\r\n        All will carry the diagnosis of Lafora disease based on the presence of characteristic\r\n        clinical history and neurological findings.\r\n\r\n        All will have a relatively advanced disease with at least one of the three cardinal\r\n        neurological manifestations: myoclonus, epilepsy and cognitive decline.\r\n\r\n        All patients will have histological or (preferable) genetic confirmation of diagnosis.\r\n\r\n        All patients will also be on stable doses of concomitant medications for at least 2 weeks\r\n        prior to the onset of the study.\r\n\r\n        Patients must not have the presence or history of any medical condition that can reasonably\r\n        be expected to subject the patient to unwarranted risk.\r\n\r\n        Patients must have no clinically significant laboratory abnormality that can reasonably be\r\n        expected to subject the patient to unwarranted risk.\r\n\r\n        Patients must not have contraindications to the use of ketogenic diet: carnitine\r\n        deficiency, organic acidurias, defects in beta-oxidation, clinically significant\r\n        nephrolithiasis, and those who are immunosuppressed .\r\n\r\n        Pregnant women will be excluded. Those not practicing effective means of birth control will\r\n        be excluded since the influence of this investigational therapy on the unborn child and\r\n        reproductive organs is unknown. Urine pregnancy test will be performed on women of\r\n        childbearing age.\r\n\r\n        Forbidden medications:\r\n\r\n        No significant interactions are generally expected between therapy with ketogenic diet and\r\n        other concomitant medications. However, those carbohydrate-containing drug preparations\r\n        which may interfere with the achievement of persistent ketosis, will be avoided as\r\n        possible. Moreover, in case of unexpected hospital visits requiring IV fluids, patients and\r\n        their parents will be asked to advise the treating medical staff on the need to avoid the\r\n        use of dextrose-containing solutions, to minimize risks of iatrogenic seizures.\r\n\r\n        Anticonvulsant medications, in general, do not negatively interact with the ketogenic diet,\r\n        but concomitant use of drugs such as Topiramate (sometimes associated with nephrolithiasis)\r\n        will be avoided as possible.\r\n\r\n        As mentioned earlier, doses of VPA, commonly used in patients with myoclonic epilepsy, will\r\n        be decreased by 25%, as KD may significantly elevate serum plasma levels of VPA.\r\n      ","sponsor":"National Institute of Neurological Disorders and Stroke (NINDS)","sponsor_type":"NIH","conditions":"Lafora Disease","interventions":{},"outcomes":{}}
{"nct_id":"NCT00157820","start_date":"2000-11-30","phase":"N/A","enrollment":354,"brief_title":"DATAS: The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study","official_title":"DATAS: The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study","primary_completion_date":"2005-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2005-10-31","last_update":"2017-04-06","description":"The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study (DATAS) was designed to analyze the ability of dual chamber ICDs, to reduce clinically significant adverse events as compared to single chamber ICD in a non selected population with conventional indication of ICD implantation.","other_id":"SP-DATAS","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Meet the Class I implantation criteria for single chamber implantable cardioverter\r\n             defibrillator according to the guidelines (ACC/AHA).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Permanent atrial fibrillation\r\n\r\n          -  Patients without structural heart disease\r\n\r\n          -  Patient meets implantation criteria for dual-chamber pacing (symptomatic sinus node\r\n             disease, all 2nd Atrio-Ventricular (AV) block [except asymptomatic Mobitz I] and all\r\n             3rd degree AV block ).\r\n\r\n          -  Patient with previous system implanted (ICD or pacemaker).\r\n\r\n          -  Patients with biventricular stimulation or re-synchronization.\r\n\r\n          -  Patient has a mechanical right heart valve.\r\n\r\n          -  Patient has medical conditions that would preclude the testing required by the\r\n             protocol, or limit study participation.\r\n\r\n          -  Patient is unwilling or unable to cooperate or give written informed consent, or the\r\n             patient is a minor and legal guardians refuse to give informed consent.\r\n\r\n          -  Patient is or will be inaccessible for follow-up at the study center.\r\n\r\n          -  Patients who are enrolled or planning to enroll in other clinical trials during the\r\n             clinical study.\r\n      ","sponsor":"Medtronic Bakken Research Center","sponsor_type":"Industry","conditions":"Ventricular Tachycardia|Ventricular Fibrillation|Defibrillators, Implantable","interventions":[{"intervention_type":"Device","name":"Device: Single Chamber Implantable Cardioverter Defibrillator","description":"Single chamber ICD implantation: Medtronic GEM, Medtronic Marquis family of SC ICD"},{"intervention_type":"Device","name":"Device: Dual Chamber implantable cardioverter defibrilator","description":"Dual chamber ICD implantation: Jewel AF & GemIII AT as DC ICDs (DC true and SC sim arms)"}],"outcomes":[{"outcome_type":"primary","measure":"CSAE-score Rate(Clinical Significant Adverse Events Score Rate)","time_frame":"17 months","description":"Main outcome was defined as the CSAE-score during follow-up: CSAE-score rate. We assigned death as the worst outcome during the entire study; and premature cross-over as the main failure of the assigned therapy. So each CSAE was assigned 1 point but (a) death was assigned a score equal to the max number of CSAE in any individual patient in the entire study +1, and (b) premature authorized crossover was given a score equal to the max number of CSAE in any individual patient in that period. Thus, main outcome was defined as the CSAE-score over length of follow-up resulting in a CSAE-score rate."},{"outcome_type":"secondary","measure":"Number of Each of the Components of the CSAE","time_frame":"17 months","description":"The primary endpoint is a composite of 5 pre-determine Clinical Significant Adverse Events (CSAE): (1) all-cause mortality, (2) invasive intervention due to Cardiovascular cause, (3) hospitalization (>24h) or prolongation of hospitalization due to CV, (4) inappropriate shocks: two or more episodes with inappropriate shocks, (5) sustained symptomatic ATs that (a) require urgent termination or (b) lasted more than 48 h leading to therapeutic intervention.\r\nNumber of each of the components of CSAE, counts the number of events for each pre-determined level."}]}
{"nct_id":"NCT00006268","start_date":"2000-10-31","phase":"Phase 1/Phase 2","brief_title":"Immunotoxin Therapy in Treating Patients With Malignant Glioma","official_title":"Interstitial Infusion of IL 13-PE38QQR Cytotoxin in Recurrent Malignant Glioma: Phase I/II Study","study_type":"Interventional","rec_status":"Completed","completion_date":"2005-03-31","last_update":"2013-06-24","description":"RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells. This may be an effective treatment for malignant glioma. PURPOSE: Phase I/II trial to study the effectiveness of immunotoxin therapy in treating patients who have malignant glioma.","other_id":"CDR0000068211","primary_purpose":"Treatment","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        DISEASE CHARACTERISTICS:\r\n\r\n          -  Histologically proven malignant glioma (grade 3 or 4)\r\n\r\n               -  Anaplastic astrocytoma\r\n\r\n               -  Glioblastoma multiforme\r\n\r\n               -  Malignant mixed oligoastrocytoma\r\n\r\n          -  Must have undergone cranial radiotherapy with tumor dose of at least 48 Gy and at\r\n             least 12 weeks prior to study\r\n\r\n          -  Must have undergone supratentorial brain tumor surgery or biopsy\r\n\r\n          -  Must have radiographic evidence of recurrent or progressive supratentorial tumor\r\n             compared with prior study\r\n\r\n               -  Must have solid portion measuring 1.0-5.0 cm in maximum diameter\r\n\r\n               -  Maximum of 1 satellite lesion allowed if separated from the primary mass by less\r\n                  than 3 cm\r\n\r\n               -  No tumor crossing the midline\r\n\r\n               -  No leptomeningeal tumor dissemination\r\n\r\n               -  No impending herniation or spinal cord compression\r\n\r\n          -  No uncontrolled seizures\r\n\r\n        PATIENT CHARACTERISTICS:\r\n\r\n        Age:\r\n\r\n          -  18 and over\r\n\r\n        Performance status:\r\n\r\n          -  Karnofsky 60-100%\r\n\r\n        Life expectancy:\r\n\r\n          -  Not specified\r\n\r\n        Hematopoietic:\r\n\r\n          -  Absolute neutrophil count at least 1,500/mm^3\r\n\r\n          -  Hemoglobin at least 10 g/dL\r\n\r\n          -  Platelet count at least 100,000/mm^3\r\n\r\n        Hepatic:\r\n\r\n          -  PT and PTT no greater than upper limit of normal (ULN)\r\n\r\n          -  SGOT and SGPT no greater than 2.5 times ULN\r\n\r\n          -  Bilirubin no greater than 2.0 mg/dL\r\n\r\n        Renal:\r\n\r\n          -  Not specified\r\n\r\n        Other:\r\n\r\n          -  Not pregnant or nursing\r\n\r\n          -  Negative pregnancy test\r\n\r\n          -  Fertile patients must use effective contraception\r\n\r\n          -  No other malignancy within the past 5 years except curatively treated carcinoma in\r\n             situ or basal cell skin cancer\r\n\r\n        PRIOR CONCURRENT THERAPY:\r\n\r\n        Biologic therapy:\r\n\r\n          -  Not specified\r\n\r\n        Chemotherapy:\r\n\r\n          -  No prior intralesional chemotherapy for malignant glioma\r\n\r\n          -  At least 3 weeks since other prior chemotherapy (6 weeks since prior nitrosoureas) and\r\n             recovered\r\n\r\n          -  No concurrent chemotherapy\r\n\r\n        Endocrine therapy:\r\n\r\n          -  Concurrent corticosteroids allowed, but dose must remain stable or be tapered during\r\n             study\r\n\r\n        Radiotherapy:\r\n\r\n          -  See Disease Characteristics\r\n\r\n          -  No prior focal radiotherapy (e.g., any form of stereotactic radiotherapy or\r\n             brachytherapy) for malignant glioma\r\n\r\n        Surgery:\r\n\r\n          -  See Disease Characteristics\r\n\r\n        Other:\r\n\r\n          -  Recovered from any prior therapy\r\n\r\n          -  No other concurrent investigational agent\r\n      ","sponsor":"New Approaches to Brain Tumor Therapy Consortium","sponsor_type":"Other","conditions":"Brain and Central Nervous System Tumors","interventions":[{"intervention_type":"Biological","name":"Biological: cintredekin besudotox"},{"intervention_type":"Drug","name":"Drug: isolated perfusion"},{"intervention_type":"Procedure","name":"Procedure: conventional surgery"}],"outcomes":{}}
{"nct_id":"NCT00236613","start_date":"2000-09-30","phase":"Phase 2","enrollment":385,"brief_title":"A Study on Efficacy and Safety of Topiramate in the Treatment of Patients With Obesity","official_title":"A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Dose-Response Study to Assess the Efficacy and Safety of Topiramate in the Treatment of Patients With Obesity","study_type":"Interventional","rec_status":"Completed","completion_date":"2001-07-31","last_update":"2010-12-03","description":"The purpose of this study is to compare the safety and effectiveness of topiramate (64mg, 96mg, 192mg, and 384mg daily) with placebo in the treatment of obesity.","other_id":"CR003709","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Body Mass Index (BMI) >=30 and <50\r\n\r\n          -  BMI >= 27 and < 50 if patient has controlled hypertension or abnormal blood lipids\r\n\r\n          -  Stable weight\r\n\r\n          -  Female patients must be postmenopausal for at least 1 year, surgically incapable of\r\n             childbearing, practicing abstinence, or practicing an acceptable method of\r\n             contraception (requires negative pregnancy test)\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Known contraindication, or hypersensitivity to topiramate\r\n\r\n          -  Exposure to any other experimental drug or device within last 30 days\r\n\r\n          -  A diagnosis of diabetes\r\n\r\n          -  History or evidence of clinically significant liver disease, cardiovascular disease,\r\n             uncontrolled hypertension or high thyroid levels\r\n\r\n          -  History of obesity with known cause\r\n\r\n          -  History or family history of kidney stones\r\n\r\n          -  History of weight loss surgery\r\n\r\n          -  History of malignancy within last 5 years\r\n      ","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","sponsor_type":"Industry","conditions":"Obesity","interventions":[{"intervention_type":"Drug","name":"Drug: topiramate"}],"outcomes":[{"outcome_type":"primary","measure":"The percent change in body weight from baseline (at the time of randomization) to Week 24."},{"outcome_type":"secondary","measure":"Changes from baseline to week 24 in total body weight, body mass index, fasting plasma glucose; incidence of adverse events over study."}]}
{"nct_id":"NCT00111592","start_date":"2000-08-31","phase":"N/A","enrollment":208,"brief_title":"Effectiveness of a Treatment Protocol for Lower Urinary Tract Symptoms in General Practice","official_title":"Effectiveness of a Treatment Protocol for Lower Urinary Tract Symptoms in General Practice","study_type":"Interventional","rec_status":"Completed","completion_date":"2004-12-31","last_update":"2016-11-09","description":"Ageing and the availability of medication has led to an increase of elderly male patients being treated for lower urinary tract symptoms (LUTS), or voiding problems (\"prostate problems\"). However, guidelines are vague as to which patients should and which should not be treated, and how. Although several treatment modalities have proven efficacy in selected populations, it is unclear how effective these treatments are in daily practice. This study investigates the hypothesis that a treatment protocol in which clear indications are formulated for all treatment modalities is more effective, as compared to current usual primary care, in reducing both symptoms as related to the quality of voiding in elderly males.","other_id":"MEC 00-007","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":55,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  International Prostate Symptom Score > 7\r\n\r\n          -  Age > 55 years\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Heart failure\r\n\r\n          -  Diabetes type I\r\n\r\n          -  Psychiatric disorder/cognitive dysfunction\r\n\r\n          -  History of prostate surgery\r\n\r\n          -  Active treatment for lower urinary tract symptoms\r\n      ","sponsor":"Maastricht University Medical Center","sponsor_type":"Other","conditions":"Benign Prostatic Hyperplasia|Lower Urinary Tract Symptoms","interventions":[{"intervention_type":"Procedure","name":"Procedure: current usual care","description":"current usual care"},{"intervention_type":"Procedure","name":"Procedure: treatment protocol with clear indications for therapy","description":"treatment protocol with clear indications for therapy"}],"outcomes":[{"outcome_type":"primary","measure":"Degree of lower urinary tract symptoms (International Prostate Symptom Score [IPSS])"},{"outcome_type":"primary","measure":"Maximum urinary flow rate (Qmax)"},{"outcome_type":"secondary","measure":"Bother due to lower urinary tract symptoms (Danish-Prostatic Symptom Score [Dan-PSS])"},{"outcome_type":"secondary","measure":"incidence of acute urinary retention"},{"outcome_type":"secondary","measure":"incidence of urinary tract infections"}]}
{"nct_id":"NCT00261911","start_date":"2000-07-31","phase":"Phase 3","enrollment":498,"brief_title":"A Study of Sibutramine in Overweight Adolescents to Assess Weight Loss and Safety.","official_title":"A 12 Month Study to Assess Safety and Efficacy of Meridia (Sibutramine Hydrochloride Monohydrate) 10 and 15 mg in Obese Adolescents","study_type":"Interventional","rec_status":"Completed","completion_date":"2002-02-28","last_update":"2007-08-31","description":"The purpose of this study is to assess the effectiveness of sibutramine on weight loss, reduction in body size and improvement in metabolic risk factors and safety in obese adolescents.","other_id":"SB238","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":12,"maximum_age":16,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Obese adolescent males and females in good general health with a lower limit of\r\n             inclusion by BMI 2 units above the U.S. weighted mean for the 95th percentile for\r\n             weight based on age and gender to a BMI of 44 kg/m2, ages 12 to 16 years at\r\n             randomization. (Efforts should be directed to obtain a study population comprising 50%\r\n             to 75% females and at least 30% African- Americans across the study. Each site should\r\n             enroll similar numbers of patients at each age within the 12 to 16 year old age\r\n             range.)\r\n\r\n          -  Both the patient and legal guardian/parent must be able to communicate meaningfully\r\n             with the investigator, be legally competent, and provide written informed\r\n             consent/assent.\r\n\r\n          -  All patients must exhibit sufficient comprehension of written materials to be able to\r\n             follow diet and exercise recommendations, and to complete written behavioral\r\n             assessments.\r\n\r\n          -  For females of childbearing potential, a negative pregnancy test will be required\r\n             prior to study inclusion. Female patients, if sexually active, must be using adequate\r\n             contraceptive precautions (i.e., oral contraceptives, approved hormonal implant,\r\n             intrauterine device, diaphragm with spermicide, condom with spermicide). Oral\r\n             contraceptive use is permitted if used for at least 3 months before starting study\r\n             medication.\r\n\r\n          -  A serum pregnancy test, which must be negative, is required of all females.\r\n\r\n          -  The patient must have at the screening and baseline visits a mean systolic blood\r\n             pressure <=130 mm Hg, a diastolic blood pressure <=85 mm Hg, and a pulse rate <=95\r\n             beats per minute. Treated hypertensives are allowed in the study if medication has\r\n             been stable for at least 3 months.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  The patient must not have a history of anorexia nervosa.\r\n\r\n          -  The patient must not have a history of clinically significant cardiac disease,\r\n             congenital heart disease, any clinically significant abnormal cardiac condition, or be\r\n             known to have a clinically significantly abnormal ECG. Specifically excluded\r\n             conditions include coronary artery disease, clinically significant cardiac\r\n             arrhythmias, and congestive heart failure.\r\n\r\n          -  The patient must not have a history of stroke.\r\n\r\n          -  The patient must not have a history of asthma requiring chronic oral corticosteroid\r\n             therapy. A short course (<7 days) of oral corticosteroid medication is permitted for\r\n             an acute exacerbation.\r\n\r\n          -  The patient must not have a history of narrow angle glaucoma.\r\n\r\n          -  The patient must not have a history of gallstones unless status post cholecystectomy.\r\n\r\n          -  The patient must not have a history of seizures with the exception of childhood\r\n             febrile seizure.\r\n\r\n          -  The patient must not have evidence of possible renal dysfunction (creatinine >1.7\r\n             mg/dL) or hepatic dysfunction (ALT >50 IU/L, bilirubin >1.0 mg/dL). Patients must not\r\n             have evidence of active or chronic Hepatitis B or C infection.\r\n\r\n          -  The patient must not be using any of the following medications at any time during the\r\n             study: monoamine oxidase inhibitors (e.g., furazolidone, phenelzine, procarbazine\r\n             hydrochloride, selegiline), antidepressant agents (including the use of antidepressant\r\n             agents for more than 2 weeks during the 90 day period prior to screening), lithium,\r\n             serotonin reuptake inhibitors, certain opioids (dextromethorphan, meperidine,\r\n             pentazocine, and fentanyl), prescribed or over-the-counter weight loss agents,\r\n             centrally acting appetite suppressants, tryptophan, sympathomimetics, serotonergic\r\n             anti-migraine agents (including sumatriptan succinate, dihydroergotamine, etc.) or any\r\n             other medication that, in the opinion of the Investigator, may pose harm to the\r\n             patient, obscure the effects of study medication or interfere with the process of drug\r\n             absorption, distribution, metabolism, or excretion (i.e., enzyme inducers or enzyme\r\n             inhibitors).\r\n\r\n          -  Patients may not be taken off an antidepressant for the purposes of entering this\r\n             study.\r\n\r\n          -  The patient and parent/legal guardian must not have a history of alcohol or drug\r\n             addiction or substance abuse within the previous two years.\r\n\r\n          -  Patients must not be above the 95th percentile for gender and age for the following\r\n             categories at Screening, as assessed by the Child Behavior CheckList: \"thought\r\n             problems\", \"delinquent behavior\", \"aggressive behavior\", or \"attention problems\".\r\n\r\n          -  The patient must not have a t-score of greater than 65 (significantly above average)\r\n             for the total Child Depression Inventory score.\r\n\r\n          -  The patient must not have participated in rigorous, structured weight loss programs\r\n             for more than 2 weeks within the past 6 months prior to screening. Continuing\r\n             participation in less rigorous programs such as Weight Watchers is allowed; however,\r\n             the patients must have been a participant for at least 6 months prior to screening to\r\n             be allowed in the study.\r\n\r\n          -  The patient must not have participated in any investigational drug study within thirty\r\n             (30) days prior to screening.\r\n\r\n          -  The patient must not have used prescription or OTC (or herbal) weight control\r\n             medication for more than two (2) weeks during the 180 day period immediately preceding\r\n             screening. In addition, any such medication is not allowed in the trial.\r\n\r\n          -  The patient must not have previously been a patient/subject in a sibutramine trial or\r\n             have otherwise used sibutramine.\r\n\r\n          -  Pregnancy\r\n\r\n          -  Pathophysiologic or genetic syndromes associated with obesity (Cushing's syndrome,\r\n             Turner's syndrome, Prader-Willi syndrome; etc.)\r\n\r\n          -  Diabetes mellitus (FBG greater than or equal to 126 mg/dL)\r\n\r\n          -  Untreated hypothyroidism (TSH greater than 4.0 mU/L for a second generation test)\r\n\r\n          -  Malignancy\r\n\r\n          -  Patient must not have drug screen positive for recreational drugs.\r\n\r\n          -  Coagulopathies or bleeding disorders\r\n\r\n          -  Gastric bypass or other surgical procedure which has the potential to interfere with\r\n             absorption of study medication, or gastric restrictive surgery.\r\n\r\n          -  Major psychiatric illness in either the patient or patient's legal guardian/parent(s)\r\n             such as bi-polar disorder, ADD, major depression, bulimia, schizophrenia, psychosis;\r\n             etc.\r\n\r\n          -  Failure to maintain a minimum level of academic achievement during the previous 6\r\n             months prior to screening (patients are excluded if receiving multiple failing grades\r\n             in school).\r\n\r\n          -  Any other severe medical or psychiatric disorder that precludes participation.\r\n      ","sponsor":"Abbott","sponsor_type":"Industry","conditions":"Obesity","interventions":[{"intervention_type":"Drug","name":"Drug: sibutramine"}],"outcomes":[{"outcome_type":"secondary","measure":"Percent change from Baseline in BMI","time_frame":"12 months"},{"outcome_type":"primary","measure":"Absolute change in body mass index (BMI) from baseline to endpoint.","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Proportions of subjects achieving >= 5% and >=10% BMI and body weight reduction","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Absolute and percent change from Baseline in waist circumference","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Body composition (DXA)","time_frame":"12 months"},{"outcome_type":"secondary","measure":"Lipid and glycemic variables","time_frame":"12 months"}]}
{"nct_id":"NCT00015821","start_date":"2000-05-31","phase":"Phase 2","enrollment":43,"brief_title":"Thalidomide in Treating Patients With Myelofibrosis","official_title":"A Pilot Study of Thalidomide as an Inhibitor of Angiogenesis in the Treatment of Myelofibrosis With Myeloid Metaplasia (MMM)","primary_completion_date":"2007-12-31","study_type":"Interventional","rec_status":"Completed","last_update":"2013-10-08","description":"Phase II trial to study the effectiveness of thalidomide in treating patients who have myelofibrosis. Thalidomide may stop the growth of myelofibrosis by stopping blood flow to the cancer cells.","other_id":"NCI-2012-01853","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically confirmed myelofibrosis with myeloid metaplasia\r\n\r\n               -  Agnogenic myeloid metaplasia\r\n\r\n               -  Post-polycythemic myeloid metaplasia\r\n\r\n               -  Post-thrombocythemic myeloid metaplasia\r\n\r\n          -  No metastatic carcinoma, lymphoma, myelodysplasia, hairy cell leukemia, mast cell\r\n             disease, acute leukemia (including M7), or acute myelofibrosis\r\n\r\n          -  No chromosomal translocation t(9;22) or bcr/abl gene rearrangement\r\n\r\n          -  Presence of reticulin fibrosis in bone marrow and leukoerythroblastosis and\r\n             dacrocytosis in peripheral blood\r\n\r\n          -  Presence of anemia (hemoglobin less than 10 g/dL), palpable splenomegaly, or\r\n             hepatomegaly\r\n\r\n          -  Performance status - ECOG 0-2\r\n\r\n          -  Absolute neutrophil count greater than 750/mm^3\r\n\r\n          -  Platelet count less than 400,000/mm^3\r\n\r\n          -  WBC less than 50,000/mm^3\r\n\r\n          -  Bilirubin no greater than 2 mg/dL (if total bilirubin elevated, direct bilirubin must\r\n             be normal)\r\n\r\n          -  AST no greater than 3 times upper limit of normal (ULN)\r\n\r\n          -  Alkaline phosphatase no greater than 3 times ULN\r\n\r\n          -  Creatinine no greater than 1.5 mg/dL\r\n\r\n          -  Creatinine clearance at least 60 mL/min\r\n\r\n          -  Not pregnant or nursing\r\n\r\n          -  Negative pregnancy test\r\n\r\n          -  Fertile women must use at least 1 highly active method AND 1 additional effective\r\n             method of contraception for at least 4 weeks before study, during study, and for at\r\n             least 4 weeks after study\r\n\r\n          -  Fertile men must use effective contraception during study and for at least 4 weeks\r\n             after study\r\n\r\n          -  No uncontrolled infection\r\n\r\n          -  No concurrent condition that would preclude study\r\n\r\n          -  No peripheral neuropathy\r\n\r\n          -  At least 1 month since prior interferon, pirfenidone, anagrelide, or epoetin alfa\r\n\r\n          -  At least 1 month since prior hydroxyurea or other chemotherapy\r\n\r\n          -  At least 1 month since prior corticosteroids or androgen derivatives\r\n      ","sponsor":"National Cancer Institute (NCI)","sponsor_type":"NIH","conditions":"Primary Myelofibrosis","interventions":[{"intervention_type":"Drug","name":"Drug: thalidomide","description":"Given PO"},{"intervention_type":"Other","name":"Other: laboratory biomarker analysis","description":"Correlative studies"}],"outcomes":[{"outcome_type":"primary","measure":"Confirmed Response, i.e., an objective status of complete or partial response, recorded on 2 consecutive evaluations at least 4 weeks apart.","time_frame":"Up to 5 years","description":"The proportion of successes will be estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients) and 95% confidence intervals calculated using the Duffy-Santner algorithm for multi-stage designs."},{"outcome_type":"secondary","measure":"Survival","time_frame":"Number of days from registration date to the date of death or last follow-up, assessed up to 5 years","description":"Kaplan-Meier survival curves will be generated to estimate survival."},{"outcome_type":"secondary","measure":"Time to progression","time_frame":"Number of days from registration date to the date of disease progression or last follow-up, assessed up to 5 years","description":"Kaplan-Meier survival curves will be generated to estimate time to progression."},{"outcome_type":"secondary","measure":"Response duration","time_frame":"Number of days from the first date that objective status = complete or partial response was recorded to the date of disease progression or date of death, whichever comes first, assessed up to 5 years","description":"Kaplan-Meier survival curves will be generated to estimate response duration."}]}
{"nct_id":"NCT00005046","start_date":"2000-04-30","phase":"Phase 1","brief_title":"Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian or Primary Peritoneal Cancer","official_title":"A Phase I Open Label Assessment of the Safety and Pharmacokinetics of Intraperitoneal PACLIMER Microspheres (Polilactofate/Paclitaxel) in Patients With Ovarian Cancer","primary_completion_date":"2007-01-31","study_type":"Interventional","rec_status":"Completed","last_update":"2013-05-27","description":"RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of paclitaxel in treating patients who have recurrent or persistent ovarian or primary peritoneal cancer.","other_id":"CDR0000067638","primary_purpose":"Treatment","sampling_method":"","gender":"Female","minimum_age":21,"population":"","criteria":"\n        DISEASE CHARACTERISTICS: Recurrent or persistent ovarian and/or primary peritoneal\r\n        carcinoma Adequate potential intraperitoneal fluid distribution with no gross fluid\r\n        loculations and adhesions that would significantly affect intraperitoneal drug distribution\r\n\r\n        PATIENT CHARACTERISTICS: Age: 21 and over Performance status: GOG 0-2 Life expectancy: At\r\n        least 6 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 WBC at least\r\n        3,000/mm3 Platelet count at least 100,000/mm3 Granulocyte count at least 1,500/mm3 Hepatic:\r\n        Bilirubin no greater than 1.5 times upper limit of normal Renal: Creatinine less than 2.0\r\n        mg/dL Other: No other sufficiently severe medical problems unrelated to malignancy that\r\n        would preclude study compliance or cause exposure to undue risks No prior unmanageable\r\n        reaction to paclitaxel\r\n\r\n        PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks\r\n        since prior myelosuppressive chemotherapy (6 weeks for nitrosourea and mitomycin) and\r\n        recovered Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior\r\n        radiotherapy to major bone marrow containing areas Surgery: Not specified Other: At least 1\r\n        month since other prior investigational agents\r\n      ","sponsor":"Gynecologic Oncology Group","sponsor_type":"Other","conditions":"Ovarian Cancer|Primary Peritoneal Cavity Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: chemotherapy"},{"intervention_type":"Drug","name":"Drug: paclitaxel"}],"outcomes":{}}
{"nct_id":"NCT00005844","start_date":"2000-04-30","phase":"Phase 1","enrollment":26,"brief_title":"Oxaliplatin in Treating Children With Advanced Solid Tumors","official_title":"A Phase I Study of Oxaliplatin in Children With Solid Tumors","primary_completion_date":"2007-09-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-09-30","last_update":"2012-10-23","description":"RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of oxaliplatin in treating children who have advanced solid tumors.","other_id":"CDR0000067860","primary_purpose":"Treatment","sampling_method":"","gender":"All","maximum_age":21,"population":"","criteria":"\n        DISEASE CHARACTERISTICS:\r\n\r\n          -  Histologically confirmed metastatic or unresectable solid tumors that are not amenable\r\n             to standard treatment\r\n\r\n               -  Histological confirmation not required for brain stem tumors\r\n\r\n          -  No known brain metastases\r\n\r\n          -  No leukemia\r\n\r\n        PATIENT CHARACTERISTICS:\r\n\r\n        Age:\r\n\r\n          -  21 and under\r\n\r\n        Performance status:\r\n\r\n          -  ECOG 0-2 OR\r\n\r\n          -  Lansky 50-100%\r\n\r\n        Life expectancy:\r\n\r\n          -  Not specified\r\n\r\n        Hematopoietic:\r\n\r\n          -  Absolute neutrophil count at least 1,000/mm^3 (except with marrow involvement)\r\n\r\n          -  Hemoglobin at least 8 g/dL\r\n\r\n          -  Platelet count at least 100,000/mm^3\r\n\r\n        Hepatic:\r\n\r\n          -  Bilirubin 0.2-1.4 mg/dL\r\n\r\n          -  AST/ALT no greater than 3 times upper limit of normal\r\n\r\n        Renal:\r\n\r\n          -  Creatinine normal for age OR\r\n\r\n          -  Creatinine clearance at least 50 mL/min\r\n\r\n          -  Electrolytes, calcium, and phosphorus normal\r\n\r\n        Cardiovascular:\r\n\r\n          -  No symptomatic congestive heart failure, unstable angina, or cardiac arrhythmia\r\n\r\n        Other:\r\n\r\n          -  Not pregnant or nursing\r\n\r\n          -  Fertile patients must use effective contraception\r\n\r\n          -  HIV negative\r\n\r\n          -  No active graft-vs-host disease (GVHD)\r\n\r\n          -  No allergy to platinum compounds or antiemetics\r\n\r\n          -  No uncontrolled concurrent illness or infection\r\n\r\n          -  No evidence of neuropathy\r\n\r\n          -  Blood sugar normal\r\n\r\n        PRIOR CONCURRENT THERAPY:\r\n\r\n        Biologic therapy:\r\n\r\n          -  At least 1 week since prior hematopoietic growth factors\r\n\r\n          -  At least 3 months since prior stem cell transplantation and recovered\r\n\r\n        Chemotherapy:\r\n\r\n          -  At least 3 weeks since prior chemotherapy (6 weeks for nitrosourea)\r\n\r\n        Endocrine therapy:\r\n\r\n          -  Not specified\r\n\r\n        Radiotherapy:\r\n\r\n          -  At least 6 weeks since prior extensive radiotherapy to significant marrow-containing\r\n             compartment\r\n\r\n          -  At least 6 months since prior craniospinal radiotherapy; total abdominal, pelvic, or\r\n             extensive lung radiotherapy; or mantle and Y-port radiotherapy\r\n\r\n          -  At least 6 months since prior total body irradiation\r\n\r\n        Surgery:\r\n\r\n          -  Not specified\r\n\r\n        Other:\r\n\r\n          -  No concurrent therapy for GVHD\r\n\r\n          -  No other concurrent anticancer investigational or commercial agents\r\n\r\n          -  No other concurrent anticancer therapy\r\n      ","sponsor":"St. Jude Children's Research Hospital","sponsor_type":"Other","conditions":"Unspecified Childhood Solid Tumor, Protocol Specific","interventions":[{"intervention_type":"Drug","name":"Drug: oxaliplatin"}],"outcomes":{}}
{"nct_id":"NCT00006100","start_date":"2000-04-30","phase":"Phase 1","brief_title":"Allogeneic Epstein Barr Virus-Specific Cytotoxic T-Lymphocytes in Treating Patients With Progressive, Relapsed, or Refractory Hodgkin's Lymphoma","official_title":"A Phase I Pilot Trial to Evaluate the Toxicity of Epstein-Barr Virus Specific T-Lymphocytes or Peripheral Blood Mononuclear Cells for the Treatment of Relapsed/Refractory Hodgkin's Disease","study_type":"Interventional","rec_status":"Unknown status","last_update":"2013-12-18","description":"RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Donor white blood cells that are treated in the laboratory with Epstein-Barr virus may be effective treatment for Hodgkin's lymphoma. PURPOSE: Phase I trial to study the effectiveness of allogeneic Epstein-Barr virus-specific cytotoxic T cells in treating patients who have progressive, relapsed, or refractory Hodgkin's lymphoma.","other_id":"CDR0000068109","primary_purpose":"Treatment","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":75,"population":"","criteria":"\n        DISEASE CHARACTERISTICS:\r\n\r\n          -  Histologically proven Hodgkin's lymphoma\r\n\r\n               -  Progressive, relapsed, or refractory disease after prior chemotherapy,\r\n                  radiotherapy, and/or stem cell transplantation\r\n\r\n               -  Epstein Barr virus (EBV) positive by immunohistochemical staining for LMP-1 or 2\r\n                  OR the presence of EBV RNA (EBER)\r\n\r\n          -  Availability of an HLA identical or haploidentical donor for cytotoxic T-lymphocytes,\r\n             meeting the following criteria:\r\n\r\n               -  EBV seropositive\r\n\r\n               -  HIV negative\r\n\r\n               -  HTLV-1 negative\r\n\r\n               -  Hepatitis B surface antigen and hepatitis B core antibody IgM negative\r\n\r\n               -  Hepatitis C antibody negative\r\n\r\n               -  Must share at least 1 HLA haplotype with donor\r\n\r\n        PATIENT CHARACTERISTICS:\r\n\r\n        Age:\r\n\r\n          -  18 to 75\r\n\r\n        Performance status:\r\n\r\n          -  Not specified\r\n\r\n        Life expectancy:\r\n\r\n          -  At least 8 weeks\r\n\r\n        Hematopoietic:\r\n\r\n          -  Not specified\r\n\r\n        Hepatic:\r\n\r\n          -  Bilirubin less than 2.0 mg/dL\r\n\r\n          -  SGOT/SGPT less than 2.5 times normal (unless liver metastases are present)\r\n\r\n               -  If there is liver involvement by disease, an obvious relationship between\r\n                  SGOT/SGPT and disease activity is required\r\n\r\n          -  No hepatic dysfunction causing moribundity\r\n\r\n        Renal:\r\n\r\n          -  Creatinine clearance greater than 50 mL/min\r\n\r\n          -  No renal dysfunction causing moribundity\r\n\r\n        Cardiovascular:\r\n\r\n          -  No cardiac dysfunction causing moribundity\r\n\r\n        Pulmonary:\r\n\r\n          -  No pulmonary dysfunction causing moribundity\r\n\r\n        Other:\r\n\r\n          -  No neurologic dysfunction causing moribundity\r\n\r\n          -  No history of severe transfusion reactions with blood products (including fetal calf\r\n             serum)\r\n\r\n          -  Not pregnant\r\n\r\n        PRIOR CONCURRENT THERAPY:\r\n\r\n        Biologic therapy:\r\n\r\n          -  See Disease Characteristics\r\n\r\n        Chemotherapy:\r\n\r\n          -  See Disease Characteristics\r\n\r\n          -  No concurrent antimetabolites\r\n\r\n        Endocrine therapy:\r\n\r\n          -  Not specified\r\n\r\n        Radiotherapy:\r\n\r\n          -  See Disease Characteristics\r\n\r\n        Surgery:\r\n\r\n          -  Not specified\r\n      ","sponsor":"Milton S. Hershey Medical Center","sponsor_type":"Other","conditions":"Lymphoma","interventions":[{"intervention_type":"Biological","name":"Biological: aldesleukin"},{"intervention_type":"Biological","name":"Biological: allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes"},{"intervention_type":"Drug","name":"Drug: fludarabine phosphate"},{"intervention_type":"Procedure","name":"Procedure: peripheral blood stem cell transplantation"}],"outcomes":{}}
{"nct_id":"NCT00005095","start_date":"2000-03-31","enrollment":6000,"brief_title":"Specimen and Data Study for Ovarian Cancer Early Detection and Prevention","official_title":"Northwestern Ovarian Cancer Early Detection & Prevention Program: A Specimen and Data Study","primary_completion_date":"2020-12-31","study_type":"Observational","rec_status":"Unknown status","last_update":"2016-09-30","description":"RATIONALE: To improve strategies for detection and prevention of early-stage disease. PURPOSE: This research study is collecting specimens and data to develop better methods for early detection and prevention of ovarian cancer among the high risk population and those who have the disease.","other_id":"NU 99G8","time_perspective":"Prospective","sampling_method":"Non-Probability Sample","gender":"Female","minimum_age":18,"maximum_age":80,"population":"Women at high risk of ovarian cancer due to family or personal medical history, or a\r\n        gynecologic abnormality.","criteria":"\n        DISEASE CHARACTERISTICS:\r\n\r\n          -  Meets one of the following criteria:\r\n\r\n               -  Considered to be at increased risk for developing ovarian cancer, as defined by\r\n                  one of the following:\r\n\r\n                    -  Has at least one first-degree relative (mother, sister, or daughter) with\r\n                       ovarian, primary peritoneal, or fallopian tube cancer\r\n\r\n                    -  Has at least two first or second degree relatives diagnosed before age 50\r\n                       with either ovarian, primary peritoneal, fallopian tube, and/or pancreatic\r\n                       cancer who have tested positive for hereditary cancer syndrome that includes\r\n                       an increased risk of gynecologic cancer (e.g., BRCA1/2 or Lynch Syndrome)or\r\n                       have increased risk as deemed by a certified genetic counselor\r\n\r\n                    -  A personal or family history of a hereditary cancer syndrome that includes\r\n                       an increased risk of gynecologic cancer\r\n\r\n                    -  Increased risk as deemed by a certified genetic counselor\r\n\r\n               -  Undergoing surgery for a gynecologic condition, including any of the following:\r\n\r\n                    -  Diagnosis of a reproductive cancer\r\n\r\n                    -  Benign gynecological condition (e.g., uterine leiomyomata, endometriosis,\r\n                       pelvic inflammatory disease, or follicular or corpus luteum ovarian cysts)\r\n\r\n                    -  Highly suspicious adnexal mass\r\n\r\n                    -  Risk-reducing prophylactic oophorectomy\r\n\r\n        PATIENT CHARACTERISTICS:\r\n\r\n        Age\r\n\r\n          -  Between the ages of 18 and 80\r\n      ","sponsor":"Northwestern University","sponsor_type":"Other","conditions":"Cervical Cancer|Endometrial Cancer|Fallopian Tube Cancer|Hereditary Breast/Ovarian Cancer (brca1, brca2)|Ovarian Cancer|Sarcoma|Uterine Leiomyomata|Vaginal Cancer|Vulvar Cancer","interventions":[{"intervention_type":"Other","name":"Other: laboratory biomarker analysis","description":"Subject's blood collected at their follow-up blood draw will be assessed for biomarkers that could lead to a panel for detecting early stage ovarian cancer."},{"intervention_type":"Other","name":"Other: screening questionnaire administration","description":"Questionnaires designed to assess quality of life for women at increased risk of ovarian cancer will be administered to the subjects. Clinical data will also be collected."},{"intervention_type":"Procedure","name":"Procedure: study of high risk factors","description":"Subjects will be assessed for high risk factors."}],"outcomes":[{"outcome_type":"primary","measure":"Identification and development of highly sensitive and specific tumor markers for the detection and management of ovarian cancer and other gynecological malignancies","time_frame":"Outcomes will be assessed at the completion of the study."},{"outcome_type":"secondary","measure":"Identification of new prevention approaches and therapies","time_frame":"Outcomes will be assessed at the completion of the study."},{"outcome_type":"secondary","measure":"Identification of measures to improve the quality of life for women at increased risk for developing the disease and for women diagnosed with ovarian cancer","time_frame":"Outcomes will be assessed at the completion of the study."}]}
{"nct_id":"NCT00820989","start_date":"2000-02-29","phase":"Phase 1","enrollment":116,"brief_title":"Inflammation and the Host Response to Injury (In Healthy Volunteers)","official_title":"Inflammation and the Host Response to Injury (In Healthy Volunteers)","primary_completion_date":"2011-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-02-28","last_update":"2014-05-21","description":"The body's immune response to injury or infection is very complex.Endotoxin is a man-made substance, which causes the body to \"mimic\" sickness (fever,chills, and achiness)for a few hours. This study is designed to determine whether certain proteins, genetics, or heart rate variability change affects the body's response to endotoxin.","other_id":"0220013432","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":40,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Good general health as demonstrated by medical history,physical exam, and laboratory\r\n             tests within 6 weeks of study.\r\n\r\n          -  Written informed consent prior to the performance of any study related procedure.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  History of cancer, rheumatoid arthritis, or immunological, renal, hepatic, endocrine,\r\n             neurologic, heart disease or hypertension\r\n\r\n          -  Recent history of alcohol or drug abuse\r\n\r\n          -  Mental capacity limited to the extent that the subject cannot provide written informed\r\n             consent or information regarding treatment-emergent adverse events and/or tolerance of\r\n             study medication and/or study procedures\r\n\r\n          -  Exposure to any experimental agent or procedure within 30 days of study\r\n\r\n          -  Pregnancy or breast feeding\r\n\r\n          -  Prior exposure to endotoxin in an experimental setting -\r\n      ","sponsor":"Rutgers, The State University of New Jersey","sponsor_type":"Other","conditions":"Immune System","interventions":[{"intervention_type":"Biological","name":"Biological: Endotoxin, Lipopolysaccharide, LPS","description":"Clinical Center Reference Endotoxin, lot 2, sterile saline, 2 ng/kg, bolus IV administration (~5 minutes)"}],"outcomes":[{"outcome_type":"primary","measure":"Physiological, Hematological, Immunological Responses","time_frame":".5-24 hours after Endotoxin administration"}]}
{"nct_id":"NCT00388648","start_date":"2000-01-31","phase":"Phase 4","enrollment":160,"brief_title":"Very Low Protein Diet or Dialysis in Uremic Elderly?","official_title":"Efficacy and Safety of a Very Low Protein Diet in Postponing Dialysis in Elderly: a Prospective Randomized Multicenter Controlled Study","study_type":"Interventional","rec_status":"Completed","completion_date":"2005-07-31","last_update":"2006-10-17","description":"There are no solid data on the real advantage of an early start of dialysis, as suggested by the DOQI guidelines. Uremic patients frequently have a poor nutritional status. However, we cannot distinguish between the detrimental effect on nutrition of too low a residual renal function or too long a period of low protein-diet, per se. However, it appears that a very-low-protein diet (VLPD) supplemented with essential amino acids and keto-analogs of amino acids, and with an adequate quantity of calories, can prevent hypoalbuminemia at the start of dialysis and can slow the progression of chronic renal failure. EDTA and USRDS data suggest that most patients starting dialysis nowadays are elderly, who also have the highest incidence of morbidity and mortality. Moreover, hospitalization rate becomes higher after the start of dialysis compared to the pre-dialysis period. Can an aminoacid-supplemented VLPD, prolonged beyond the GFR limits suggested by DOQI, offer elderly patients better survival and better quality of life than dialysis? The answer can only come from a prospective, randomized trial, in elderly patients, starting at the GFR values suggested by the NKF-DOQI for starting dialysis, comparing outcomes with a vegetarian VLPD supplemented with a mixture of keto-analogs of amino acids and essential amino acids, and with dialysis.","other_id":"NBs2000","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":70,"maximum_age":95,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. males or females >= 70 years of age\r\n\r\n          2. RRF 5-7 ml/min/1.73 m2\r\n\r\n          3. left ventricular ejection fraction >40%\r\n\r\n          4. signed informed written consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. diabetes\r\n\r\n          2. severe cerebral disease\r\n\r\n          3. proteinuria >3 g/24 h\r\n\r\n          4. severe hepatic failure\r\n\r\n          5. active malignancy\r\n\r\n          6. COPD requiring supplementary oxygen\r\n\r\n          7. AIDS, or HIV-positive\r\n      ","sponsor":"Universit degli Studi di Brescia","sponsor_type":"Other","conditions":"Uremia|Elderly (Aged >70)|Dialysis|Low Protein Diet|Survival","interventions":[{"intervention_type":"Drug","name":"Drug: mixture of amino and keto acids"}],"outcomes":[{"outcome_type":"primary","measure":"The primary hypotheses to be tested are whether, at least in the elderly:"},{"outcome_type":"primary","measure":"the supplemented Very Low Protein Diet (VLPD) does not increase the risk of morbidity and mortality,"},{"outcome_type":"primary","measure":"a prolonged period of VLPD can postpone the need for dialysis in elderly patients, and dialysis can start at a RRF lower than usually suggested."},{"outcome_type":"secondary","measure":"the VLPD does not induce malnutrition."}]}
{"nct_id":"NCT02177565","start_date":"2000-01-31","phase":"N/A","enrollment":35,"brief_title":"Autologous Stem Cell Therapy for Fracture Non-union Healing","official_title":"Autologous Stem Cell Therapy for Fracture Non-union Healing","primary_completion_date":"2011-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2011-10-31","last_update":"2020-03-11","description":"Do mesenchymal stem cells accelerate new bone formation in persistent non-unions.","other_id":"RL1 254","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":76,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  An established non-union according to the US Food & Drug Administration criteria14.\r\n\r\n          -  Non-union following fracture of tibia or femur suitable for synthetic bone grafting.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Skeletal immaturity.\r\n\r\n          2. Pregnant or breast-feeding.\r\n\r\n          3. Non-union following pathological fractures.\r\n\r\n          4. Positive to Hepatitis B, Hepatitis-C or HIV.\r\n\r\n          5. Infection during BMSC culture.\r\n      ","sponsor":"Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust","sponsor_type":"Other","conditions":"Non-union of Fractures","interventions":[{"intervention_type":"Biological","name":"Biological: carrier plus in vitro expanded autologous BMSCs","description":"The non-unions of fractures were stabilized with internal or external fixation devices. The non-union site was clearly exposed and decorticated to introduce sub-periosteal bone graft. Depending on the surgical approach, the site was partitioned in either medial/lateral or anterior/posterior sides. The contents of each universal container were mixed individually with a carrier by the surgeon, who was blinded to the contents of the container"}],"outcomes":[{"outcome_type":"primary","measure":"Radiological assessment of new callus and fracture bridging","time_frame":"12 months","description":"The primary outcome measure was formation of new callus and cortical bridging, assessed from pre-operative and multiple post-operative radiographs and CT-scans up to 12 months. These images were divided into early (0-3 months) and late (9-12 months) groups. Non-unions were assessed from anonymized slides by four independent reviewers (two radiologists and two orthopedic surgeons) blinded to the side of cell insertion. Each slide had a pre-operative radiograph for comparison but no indication of time since surgery, and showed a medial/ lateral or an anterior/ posterior view depending on the surgical approach . At first, each reviewer indicated the side with largest callus and most cortical bridging pre-operatively. Then each reviewer examined subsequent radiographs to indicate the side with the largest increase in new callus and cortical bridging."},{"outcome_type":"secondary","measure":"EQ-5D","time_frame":"12 months","description":"Change in EQ-5D index at 1 year was used as secondary outcome measures."}]}
{"nct_id":"NCT00003325","start_date":"1999-12-31","phase":"Phase 3","enrollment":515,"brief_title":"Lymphatic Mapping in Treating Patients With Stage I or Stage II Cancer of the Vulva","official_title":"Intraoperative Lymphatic Mapping in Patients With Stage I and II Squamous Carcinoma of the Vulva","primary_completion_date":"2013-07-31","study_type":"Interventional","rec_status":"Completed","last_update":"2015-05-29","description":"RATIONALE: Lymphatic mapping may improve the ability to detect cancer of the vulva. PURPOSE: This phase III trial is studying how well lymphatic mapping works in treating patients with stage I or stage II cancer of the vulva.","other_id":"GOG-0173","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Female","population":"","criteria":"\n        DISEASE CHARACTERISTICS:\r\n\r\n          -  Histologically confirmed invasive squamous cell carcinoma of the vulva that is greater\r\n             than 1 mm in thickness as measured from the nearest rete peg\r\n\r\n               -  Tumor size must be 2-6 cm\r\n\r\n               -  No recurrent disease\r\n\r\n          -  Prior excision of the primary disease or a history of carcinoma in situ of the vulva\r\n             allowed\r\n\r\n          -  No tumor extending into the urethra, anus, vagina, rectum, or bladder\r\n\r\n          -  No grossly suspicious or inflamed groin nodes on physical exam\r\n\r\n          -  No grossly infected primary tumors\r\n\r\n        PATIENT CHARACTERISTICS:\r\n\r\n        Age:\r\n\r\n          -  Any age\r\n\r\n        Performance status:\r\n\r\n          -  GOG 0-3\r\n\r\n        Life expectancy:\r\n\r\n          -  Not specified\r\n\r\n        Hematopoietic:\r\n\r\n          -  Not specified\r\n\r\n        Hepatic:\r\n\r\n          -  Not specified\r\n\r\n        Renal:\r\n\r\n          -  Not specified\r\n\r\n        Other:\r\n\r\n          -  No other invasive malignancy within the past 5 years except non-melanomatous skin\r\n             cancer\r\n\r\n          -  No known hypersensitivity to phenylethane compounds\r\n\r\n        PRIOR CONCURRENT THERAPY:\r\n\r\n          -  No prior cancer therapy that contraindicates therapy in this study\r\n\r\n        Biologic therapy:\r\n\r\n          -  Not specified\r\n\r\n        Chemotherapy:\r\n\r\n          -  Not specified\r\n\r\n        Endocrine therapy:\r\n\r\n          -  Not specified\r\n\r\n        Radiotherapy:\r\n\r\n          -  Not specified\r\n\r\n        Surgery:\r\n\r\n          -  See Disease Characteristics\r\n\r\n          -  No prior groin dissection\r\n      ","sponsor":"Gynecologic Oncology Group","sponsor_type":"Other","conditions":"Vulvar Cancer","interventions":[{"intervention_type":"Procedure","name":"Procedure: Sentinel lymph node mapping","description":"Sentinel lymph node mapping"}],"outcomes":[{"outcome_type":"primary","measure":"Predictive value of negative sentinel lymph nodes in vulvar cancer patients","time_frame":"at time of surgery"}]}
{"nct_id":"NCT00004293","start_date":"1999-11-30","phase":"Phase 2","enrollment":24,"brief_title":"Phase II Study of Glucocerebrosidase in Patients With Gaucher Disease","study_type":"Interventional","rec_status":"Unknown status","last_update":"2005-06-24","description":"OBJECTIVES: I. Evaluate the efficacy and toxicity of glucocerebrosidase enzyme therapy in patients with Gaucher disease.","other_id":"199/11725","primary_purpose":"Treatment","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        PROTOCOL ENTRY CRITERIA:\r\n\r\n        --Disease Characteristics-- Gaucher disease with glucocerebrosidase deficiency confirmed by\r\n        enzymatic or molecular assay At least 3 organ systems affected, based on the following\r\n        criteria: Anemia Thrombocytopenia Organomegaly Bone deterioration on radiograph Pulmonary\r\n        compromise Symptoms compromise daily activities or risk longevity No neurologic disease\r\n      ","sponsor":"National Center for Research Resources (NCRR)","sponsor_type":"NIH","conditions":"Gaucher's Disease","interventions":[{"intervention_type":"Drug","name":"Drug: glucocerebrosidase"}],"outcomes":{}}
{"nct_id":"NCT00363025","start_date":"1999-11-30","phase":"Phase 3","enrollment":465,"brief_title":"A Randomized Study of Post-Remission Therapy in Elderly Patients With Acute Myelogenous Leukemia.","official_title":"A Randomized Multicenter Study of More Intensive Versus Less Intensive Post-Remission Therapy in Elderly Patients With Acute Myelogenous Leukemia (AML) or Transformed Refractory Anemia With Excess Blasts (RAEB-t).","study_type":"Interventional","rec_status":"Terminated","completion_date":"2006-04-30","last_update":"2008-02-21","description":"In this ALFA-9803 trial in AML patients aged 65 years or more, we randomly compared idarubicin or daunorubicin throughout the study (first randomization) and two different post-remission strategies (second randomization): one single intensive consolidation course similar to induction versus six ambulatory cycles with one dose of idarubicin/daunorubicin (day 1) and 2x60 mg/m2/d cytarabine SC (day 1 to 5) delivered in out-patients on a monthly basis. Primary endpoint was 2-year overall survival (OS). Study hypotheses were equivalence for the idarubicin/daunorubicin comparison and a 15% difference in 2-year OS for the post-remission therapy comparison.","other_id":"ALFA-9803","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        Male or female aged 65 years or more. Patient with previously untreated AML except M3 in\r\n        the FAB classification. Patient with previously untreated transformed refractory anemia\r\n        with excess blasts (RAEB-t).\r\n\r\n        Patients with AML secondary to a previously untreated myelodysplastic syndrome (MDS),\r\n        documented or not, are eligible, as well as those with RAEB-t evolving from a previous\r\n        known MDS.\r\n\r\n        Patients with a Performance Status < 3. Patient who has given his/her written informed\r\n        consent.\r\n\r\n        Exclusion Criteria:\r\n\r\n        Patients with AML3 in the FAB classification. Patients with blast crisis of previously\r\n        known myeloproliferative syndrome. Patients with AML secondary to previous treatment with\r\n        cytotoxic chemotherapy or radiotherapy (therapy-related AML).\r\n\r\n        Patients with another concommitant neoplasia. Patients with leukemic central nervous system\r\n        involvement. Patients with a Grade > 2 uncontrolled infection. Patients with Grade > 2\r\n        visceral contra-indications to treatment with induction chemotherapy (except if\r\n        leukemia-related).\r\n\r\n        Bilirubin > 2 times the normal range of the laboratory. Serum creatinine > 2 times the\r\n        normal range of the laboratory. Patients with cardiac contra-indication to treatment with\r\n        anthracyclines.\r\n      ","sponsor":"Acute Leukemia French Association","sponsor_type":"Other","conditions":"Acute Myeloid Leukemia","interventions":[{"intervention_type":"Procedure","name":"Procedure: Two post-remission strategies"},{"intervention_type":"Drug","name":"Drug: Idarubicin versus daunorubicin"}],"outcomes":[{"outcome_type":"primary","measure":"Overall survival"},{"outcome_type":"secondary","measure":"Complete remission rate"},{"outcome_type":"secondary","measure":"Induction death rate"}]}
{"nct_id":"NCT00019669","start_date":"1999-10-31","phase":"Phase 2","brief_title":"Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma","official_title":"Immunization of Patients With Metastatic Melanoma Using a Recombinant Fowlpox Virus Encoding a GP100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence","study_type":"Interventional","rec_status":"Completed","completion_date":"2007-10-31","last_update":"2013-06-20","description":"RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether combining melanoma vaccine with interleukin-2 is more effective than vaccine therapy alone in treating metastatic melanoma. PURPOSE: Phase II trial to compare the effectiveness of melanoma vaccine and interleukin-2 with that of melanoma vaccine alone in treating patients who have metastatic melanoma that has not responded to previous treatment.","other_id":"CDR0000066961","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":16,"population":"","criteria":"\n        DISEASE CHARACTERISTICS:\r\n\r\n          -  Histologically proven metastatic melanoma that has failed standard treatment\r\n\r\n          -  Measurable disease\r\n\r\n          -  HLA-A-201 positive\r\n\r\n        PATIENT CHARACTERISTICS:\r\n\r\n        Age:\r\n\r\n          -  16 and over\r\n\r\n        Performance status:\r\n\r\n          -  ECOG 0-2\r\n\r\n        Life expectancy:\r\n\r\n          -  More than 3 months\r\n\r\n        Hematopoietic:\r\n\r\n          -  WBC  3,000/mm^3\r\n\r\n          -  Platelet count  90,000/mm^3\r\n\r\n          -  No coagulation disorders\r\n\r\n        Hepatic:\r\n\r\n          -  Bilirubin  1.6 mg/dL (less than 3.0 mg/dL for patients with Gilbert's syndrome)\r\n\r\n          -  AST/ALT < 2 times normal\r\n\r\n          -  Hepatitis B surface antigen negative\r\n\r\n        Renal:\r\n\r\n          -  Creatinine  2.0 mg/dL\r\n\r\n        Cardiovascular:\r\n\r\n          -  No major cardiovascular disease\r\n\r\n          -  No cardiac ischemia by a stress thallium test or other comparable test*\r\n\r\n          -  No myocardial infarction*\r\n\r\n          -  No cardiac arrhythmias* NOTE: *In order to be eligible to receive interleukin-2 (IL-2)\r\n\r\n        Pulmonary:\r\n\r\n          -  No major respiratory disease\r\n\r\n          -  No obstructive or restrictive pulmonary disease* NOTE: *In order to be eligible to\r\n             receive IL-2\r\n\r\n        Immunologic:\r\n\r\n          -  No autoimmune disease\r\n\r\n          -  No known immunodeficiency disease\r\n\r\n          -  No primary or secondary immunodeficiency\r\n\r\n          -  No allergy to eggs\r\n\r\n          -  No active systemic infections\r\n\r\n          -  HIV negative\r\n\r\n        Other:\r\n\r\n          -  Not pregnant\r\n\r\n          -  Negative pregnancy test\r\n\r\n          -  Fertile patients must use effective contraception\r\n\r\n          -  No other active major medical illness* NOTE: *In order to be eligible to receive IL-2\r\n\r\n        PRIOR CONCURRENT THERAPY:\r\n\r\n        Biologic therapy:\r\n\r\n          -  No prior gp100 vaccination\r\n\r\n        Chemotherapy:\r\n\r\n          -  Not specified\r\n\r\n        Endocrine therapy:\r\n\r\n          -  No concurrent steroids\r\n\r\n        Radiotherapy:\r\n\r\n          -  Not specified\r\n\r\n        Surgery:\r\n\r\n          -  Prior surgery for the malignancy allowed\r\n\r\n        Other:\r\n\r\n          -  At least 3 weeks since other prior therapy for the malignancy\r\n      ","sponsor":"National Cancer Institute (NCI)","sponsor_type":"NIH","conditions":"Melanoma (Skin)","interventions":[{"intervention_type":"Biological","name":"Biological: aldesleukin"},{"intervention_type":"Biological","name":"Biological: fowlpox virus vaccine vector"},{"intervention_type":"Biological","name":"Biological: gp100 antigen"}],"outcomes":{}}
{"nct_id":"NCT02173678","start_date":"1999-10-31","phase":"Phase 1","enrollment":12,"brief_title":"Safety and Tolerability of COMBIVENT HFA as Compared to COMBIVENT CFC and Placebo HFA in Healthy Male and Female Subjects","official_title":"A Randomized, Placebo-controlled, Double-blind, 3 Way Cross-over Safety and Tolerability Study of Single and Repetitive Dosing of COMBIVENT HFA Compared to COMBIVENT CFC and Placebo HFA in Healthy Male and Female Subjects (Cumulative Dose: 1600 mcg (HFA) or 1648 mcg (CFC) of Salbutamol Sulfate, 288 mcg of Ipratropium Bromide)","primary_completion_date":"1999-11-30","study_type":"Interventional","rec_status":"Completed","last_update":"2014-07-04","description":"Study to assess the safety and tolerability of COMBIVENT hydrofluoroalkane (HFA) as compared to COMBIVENT chlorofluorocarbons (CFC) and placebo HFA after single and repetitive dosing in healthy male and female subjects","other_id":"1012.24","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":21,"maximum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy males/females\r\n\r\n          -  Age range from 21 to 50 years and be within 20% of their normal weight (Broca-Index)\r\n\r\n          -  All female volunteers must use a safe contraception (i.e. oral contraceptives,\r\n             intrauterine devices; sterilised) and must have a negative urine pregnancy test\r\n\r\n          -  All subjects must have a negative hepatitis B, C and HIV tests as well as a negative\r\n             drug screening\r\n\r\n          -  Prior to admission to the treatment after giving his/her informed consent (in\r\n             accordance with Good Clinical Practice and local legislation) in writing, each subject\r\n             will have his/her medical history taken and will receive a complete medical\r\n             examination (incl. blood pressure and pulse rate measurements) as well as 12-lead ECG\r\n             within 14 days before the first administration of the test drug. Haematopoietic,\r\n             hepatic and renal function tests will be carried out in the laboratory. The subject\r\n             will fast for 12 hours before collection of specimens for all laboratory parameters\r\n\r\n          -  Currently non-smoking (smoke free for >= one year and <=5 pack year smoking history)\r\n\r\n          -  Normal spirometry as evidenced by a baseline FEV1 >= 90% of predicted normal value for\r\n             age, height and sex\r\n\r\n          -  Predicted normal values will be calculated according to European Community for Steel\r\n             and Coal (ECCS)\r\n\r\n          -  Ability to adequately use an inhalation aerosol device\r\n\r\n          -  Ability to perform technically satisfactory pulmonary function tests\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Volunteers will be excluded from the study if the results of the medical examination\r\n             or laboratory test (especially serum glutamate oxaloacetate transaminase (SGOT) >\r\n             2-fold of upper normal range, serum glutamate pyruvate transaminase (SGPT) > 1.5 -\r\n             fold of upper normal range) are judged by the investigator to differ significantly\r\n             from normal clinical values\r\n\r\n          -  Volunteers who have an eosinophil count >= 600/mm. A repeat eosinophil count will not\r\n             be conducted in these subjects\r\n\r\n          -  Volunteers with a serum potassium value >+- 10% outside the normal range\r\n\r\n          -  Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular,\r\n             metabolic immunological or hormonal disorders\r\n\r\n          -  Volunteers with diseases of the central nervous system (such as epilepsy) or with\r\n             psychiatric disorders\r\n\r\n          -  Volunteers with known history of orthostatic hypotension, fainting spells or blackouts\r\n\r\n          -  Volunteers with chronic or relevant acute infections\r\n\r\n          -  Volunteers with upper respiratory tract infection in the past six weeks prior to the\r\n             screening visit or between the screening visit and first test day\r\n\r\n          -  Volunteers with a history of asthma or allergic rhinitis\r\n\r\n          -  Volunteers with history of allergy/hypersensitivity (including drug allergy,\r\n             especially anticholinergics and beta-agonist agents) which is deemed relevant to the\r\n             trial as judged by the investigator\r\n\r\n          -  Volunteers with known narrow-angle glaucoma\r\n\r\n          -  Volunteers with disturbed micturition\r\n\r\n          -  Volunteers who have taken a drug with a long half-life (>= 24 hours) within ten\r\n             half-lives of the respective drug before enrolment in the study\r\n\r\n          -  Volunteers who received any concomitant therapy, including over the counter\r\n             medications (including vitamins, supplements and/or nonsteroidal antiinflammatory\r\n             drugs; excluding oral or depository contraceptives) within one week of the screening\r\n             visit\r\n\r\n          -  Volunteers who have participated in another study with an investigational drug within\r\n             the last two months preceding this study\r\n\r\n          -  Volunteers who drink more than 40g of alcohol per day\r\n\r\n          -  Volunteers who are dependent on drugs\r\n\r\n          -  Volunteers who have donated blood (>= 100 ml ) within the last four weeks\r\n\r\n          -  Volunteers who participated in excessive physical activities (e.g. competitive sports)\r\n             within the last week before the study\r\n\r\n          -  Pregnant or nursing women or women of childbearing potential not using a medically\r\n             approved means of contraception (i.e. contraceptives, intrauterine devices,\r\n             sterilised)\r\n\r\n          -  Volunteers with significant tremor measured on screening visit\r\n\r\n          -  Previous participation in this study\r\n      ","sponsor":"Boehringer Ingelheim","sponsor_type":"Industry","conditions":"Healthy","interventions":[{"intervention_type":"Drug","name":"Drug: COMBIVENT HFA-MDI"},{"intervention_type":"Drug","name":"Drug: COMBIVENT CFC-MDI"},{"intervention_type":"Drug","name":"Drug: Placebo HFA-MDI"}],"outcomes":[{"outcome_type":"primary","measure":"Potential bronchoconstriction, objectively assessed by FEV1 and the occurence of cough, wheeze and shortness of breath","time_frame":"Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation"},{"outcome_type":"primary","measure":"Forced expiratory volume in one second (FEV1)","time_frame":"Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation"},{"outcome_type":"primary","measure":"Peak expiratory flow (PEF)","time_frame":"Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation"},{"outcome_type":"primary","measure":"Forced Vital Capacity (FVC)","time_frame":"Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation"},{"outcome_type":"primary","measure":"Mean maximal expiratory flow over the middle 50% of the FVC (MMEF25/75)","time_frame":"Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation"},{"outcome_type":"primary","measure":"Changes in serum potassium levels","time_frame":"Baseline, 85, 120, 155, 170 , 200, 230, 260 min after first inhalation"},{"outcome_type":"primary","measure":"Occurence of adverse events","time_frame":"up to 30 days"},{"outcome_type":"primary","measure":"Changes in blood pressure","time_frame":"Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation"},{"outcome_type":"primary","measure":"Changes in pulse rate","time_frame":"Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation"},{"outcome_type":"primary","measure":"Changes in respiratory rate","time_frame":"Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation"},{"outcome_type":"primary","measure":"Tremor measurement","time_frame":"Baseline, 15, 50 , 85, 120, 155, 170, 200, 230, 260, 320 min. after first inhalation"},{"outcome_type":"primary","measure":"Changes in electrocardiogram (ECG), QTc interval","time_frame":"Baseline, 85, 120, 155, 170, 200 min after first inhalation (230, 260, 320 min only to be performed if abnormal ECG)"},{"outcome_type":"primary","measure":"Number of subjects with clinically relevant changes from baseline in physical examination","time_frame":"Screening, end-of study-evaluation (within 8 days after the last treatment)"},{"outcome_type":"primary","measure":"Number of subjects with clinically signification changes from baseline in laboratory values","time_frame":"Screening, end-of study-evaluation (within 8 days after the last treatment)"}]}
{"nct_id":"NCT00564837","start_date":"1999-09-30","phase":"N/A","enrollment":145,"brief_title":"Home Vs. Physiotherapy Supervised Rehabilitation After ACL Reconstruction","official_title":"Comparison of Home Vs. Physiotherapy-Supervised Rehabilitation Programs Following Reconstruction of the Anterior Cruciate Ligament (ACL)","primary_completion_date":"2001-02-28","study_type":"Interventional","rec_status":"Completed","completion_date":"2001-02-28","last_update":"2010-01-12","description":"This study was designed to determine whether or not there were any differences in knee range of motion, both statically and during gait, sagittal plane knee laxity, and quadriceps and hamstrings strength in patients three months post-ACL reconstruction with a bone-patellar tendon-bone autograft based on their performance of a primarily home based rehabilitation program or a standard physiotherapy-supervised program.","other_id":"10339","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":16,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. 16 years of age or older\r\n\r\n          2. Surgery at least 6 weeks after injury to allow for a return of full range of motion,\r\n             minimize swelling, and offset strength deficits due to pain/swelling14,28\r\n\r\n          3. ACL reconstruction with a bone-patellar tendon-bone autograft\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Previous or concomitant reconstruction of any knee ligament to either knee\r\n\r\n          2. Ongoing knee abnormality unrelated to the ACL injury (eg, evidence of changes on\r\n             radiographs consistent with osteoarthritis)\r\n\r\n          3. Professional athletes or workers' compensation patients\r\n\r\n          4. Complications during surgery (eg, inadequate graft fixation requiring protocol\r\n             modification)\r\n\r\n          5. Patients without access to local physical therapy services\r\n      ","sponsor":"University of Calgary","sponsor_type":"Other","conditions":"ACL Reconstruction","interventions":[{"intervention_type":"Procedure","name":"Procedure: Home-based rehabilitation program","description":"Home-based rehabilitation program that includes 4 physiotherapy sessions in the first 3 post-op months"},{"intervention_type":"Procedure","name":"Procedure: Physiotherapy-supervised rehabilitation program","description":"Physiotherapy-supervised rehabilitation program that includes 17 scheduled physiotherapy sessions in the first 3 post-op months"}],"outcomes":[{"outcome_type":"primary","measure":"Active assisted knee flexion and passive knee extension range of motion","time_frame":"pre-op, 6 & 12 weeks post-op"},{"outcome_type":"secondary","measure":"Knee flexion and extension range of motion during gait","time_frame":"pre-op, 6 & 12 wks post-op"},{"outcome_type":"secondary","measure":"Sagittal plane laxity of the knee","time_frame":"pre-op, 6 & 12 wks post-op"},{"outcome_type":"secondary","measure":"Isokinetic quadriceps and hamstrings strength","time_frame":"pre-op and 12wks post-op"}]}
{"nct_id":"NCT02024763","start_date":"1999-09-30","phase":"N/A","enrollment":352,"brief_title":"Educational Program and Schoolchildren's Energy Expenditure","official_title":"Effect of an Educational Program on Schoolchildren's Energy Expenditure During Physical Education Classes","primary_completion_date":"2000-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2000-11-30","last_update":"2013-12-31","description":"The aim of this study was to evaluate the impact of a classroom teachers' educational intervention on 1st and 2nd grades children's physical activity level and energy expenditure during physical education classes in elementary public schools, in So Paulo, Brazil.","other_id":"APkit","allocation":"Randomized","intervention_model":"Parallel Assignment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":7,"maximum_age":10,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  children from 7 to 10 years of age, enrolled at 1st or 2nd grades of selected schools\r\n             in Vila Mariana - Sao Paulo.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Not have both observations.\r\n      ","sponsor":"Federal University of So Paulo","sponsor_type":"Other","conditions":"Physical Activity","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: Educational Intervention","description":"Intervention was applied to classroom teachers by the multidisciplinary team of the RRIDA Project. Training lasted six weeks, 12 hours devoted to physical activity and 18 hours to nutritional content. Modules of educational activities to classroom teachers were to be replicated at PE classes to children from 1st and 2nd grades of three exposed schools. The physical activity module was based on a theoretical approach of physical activity benefits and risks for health, children's physical fitness and activity patterns, physical education and change behavior models."}],"outcomes":[{"outcome_type":"primary","measure":"Change in children's Physical Activity Level / Energy Expenditure after an Educational Intervention for classroom teachers.","time_frame":"Children's Physical Activity Level / Energy Expenditure were measured before and after an Educational Intervention to classroom teachers, with a six weeks interval.","description":"From eight elementary Public Schools we randomly selected three to receive an educational intervention for teachers. In order to evaluate intervention results, all the 1st and 2nd grades, from exposed and unexposed schools were nominated to have selected children. In each class, eight children were randomly selected. To assess children's level of physical activity, Physical Education classes were recorded. The videotapes analysis set the level of student's physical activity, teacher's attitude, and the class context. The observation instrument used was SOFIT - System for Observing Fitness Instruction Time. We analyzed and discussed the change in children's Physical Activity Level and Energy Expenditure before and after the Educational Intervention to classroom teachers, with a six weeks interval."}]}
{"nct_id":"NCT00424411","start_date":"1999-09-30","phase":"Phase 3","enrollment":300,"brief_title":"Six Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 2 Diabetes","official_title":"Efficacy and Safety of Inhaled Compared With Subcutaneous Human Insulin Therapy in Subjects With Type 2 Diabetes Mellitus: A Six-Month, Outpatient, Parallel Comparative Trial","study_type":"Interventional","rec_status":"Completed","completion_date":"2000-12-31","last_update":"2007-02-13","description":"To determine, in subjects with Type 2 Diabetes Mellitus: 1. Whether glycemic control can be achieved at least as effectively with an insulin regimen involving pre-meal EXUBERA (inhaled insulin) plus a single bedtime Ultralente injection as with a conventional subcutaneous insulin regimen involving 2 mixed Regular/NPH insulin injections per day. 2. The toleration and safety of EXUBERA (inhaled insulin) therapy and its effects after 6 months, if any, on measures of pulmonary function.","other_id":"217-108","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":35,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Type 2 Diabetes\r\n\r\n          -  Stable insulin regimen of at least 2 injections per day\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Any smoking within the last 6 months. Smoking is not permitted at any time during this\r\n             study.\r\n\r\n          -  Subjects on insulin pump during 2 months prior to screening.\r\n\r\n          -  Subjects with poorly-controlled asthma, clinically significant chronic obstructive\r\n             pulmonary disease, or other significant respiratory disease.\r\n      ","sponsor":"Pfizer","sponsor_type":"Industry","conditions":"Diabetes Mellitus, Type 2","interventions":[{"intervention_type":"Drug","name":"Drug: Inhaled human insulin (EXUBERA)"}],"outcomes":[{"outcome_type":"primary","measure":"Primary outcome is 24 week change in baseline in HbA1c."},{"outcome_type":"secondary","measure":"The secondary endpoints include the following efficacy assessments:"},{"outcome_type":"secondary","measure":"Incidence of hypoglycemia"},{"outcome_type":"secondary","measure":"Proportion of subjects with acceptable glycemic control (e.g., HbA1c<8%)"},{"outcome_type":"secondary","measure":"Change from baseline in fasting lipid profile"},{"outcome_type":"secondary","measure":"Change from baseline in fasting plasma glucose level"},{"outcome_type":"secondary","measure":"Change from baseline in meal glucose response (2-hour postprandial increment in plasma glucose)"},{"outcome_type":"secondary","measure":"Dose of insulin (total dose of injected sustained-duration insulin, and total dose of inhaled or injected Regular insulin during the study)."},{"outcome_type":"secondary","measure":"Change from baseline in body weight"},{"outcome_type":"secondary","measure":"Change from baseline in 24-hour home glucose profile (based on the area under the glucose profile curve calculated by the trapezoid rule with special weights assigned to the pre-breakfast and bedtime assessments)."},{"outcome_type":"secondary","measure":"Patient satisfaction and preference."}]}
{"nct_id":"NCT00004004","start_date":"1999-07-31","phase":"Phase 1/Phase 2","brief_title":"Procarbazine in Treating Patients With Recurrent Brain Tumor","official_title":"A Phase I/II Study of Oral Procarbazine in the Treatment of Recurrent High Grade Astrocytomas","study_type":"Interventional","rec_status":"Completed","completion_date":"2003-08-31","last_update":"2013-06-21","description":"RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I/II trial to study the effectiveness of procarbazine in treating patients who have progressive or recurrent astrocytoma, oligodendroglioma, or glioblastoma multiforme following treatment with radiation therapy.","other_id":"CDR0000067214","primary_purpose":"Treatment","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        DISEASE CHARACTERISTICS:\r\n\r\n          -  Histologically proven malignant glioma of one of the following types:\r\n\r\n               -  Anaplastic astrocytoma\r\n\r\n               -  Anaplastic oligodendroglioma\r\n\r\n               -  Glioblastoma multiforme\r\n\r\n          -  Progressive or recurrent disease after radiotherapy with or without chemotherapy\r\n\r\n          -  Measurable disease by serial MR or CT\r\n\r\n        PATIENT CHARACTERISTICS:\r\n\r\n        Age:\r\n\r\n          -  18 and over\r\n\r\n        Performance status:\r\n\r\n          -  Karnofsky 60-100%\r\n\r\n        Life expectancy:\r\n\r\n          -  Greater than 2 months\r\n\r\n        Hematopoietic:\r\n\r\n          -  Absolute neutrophil count at least 1500/mm^3\r\n\r\n          -  Platelet count at least 100,000/mm^3\r\n\r\n        Hepatic:\r\n\r\n          -  Bilirubin no greater than 1.5 mg/dL\r\n\r\n          -  SGPT/SGOT no greater than 4 times upper limit of normal\r\n\r\n        Renal:\r\n\r\n          -  Creatinine no greater than 1.7 mg/dL\r\n\r\n        Other:\r\n\r\n          -  No serious concurrent infection\r\n\r\n          -  No other illness that would preclude study\r\n\r\n          -  Not pregnant or nursing\r\n\r\n          -  Negative pregnancy test\r\n\r\n          -  Fertile patients must use effective contraception\r\n\r\n          -  No prior malignancy within the past 5 years except curatively treated basal cell skin\r\n             cancer or carcinoma in situ of the cervix\r\n\r\n        PRIOR CONCURRENT THERAPY:\r\n\r\n        Biologic therapy:\r\n\r\n          -  No concurrent filgrastim (G-CSF) during the first course\r\n\r\n        Chemotherapy:\r\n\r\n          -  See Disease Characteristics\r\n\r\n          -  No more than 1 prior chemotherapy regimen\r\n\r\n          -  At least 3 weeks since prior chemotherapy (at least 6 weeks since prior nitrosoureas)\r\n\r\n          -  No more than 2 prior courses of carmustine or lomustine and no greater than 460 mg/m2\r\n             or 220 mg/m2, respectively\r\n\r\n          -  No prior procarbazine\r\n\r\n        Endocrine therapy:\r\n\r\n          -  Not specified\r\n\r\n        Radiotherapy:\r\n\r\n          -  See Disease Characteristics\r\n\r\n          -  At least 3 months since prior radiotherapy\r\n\r\n        Surgery:\r\n\r\n          -  Prior surgery allowed\r\n\r\n        Other:\r\n\r\n          -  Recovered from toxicity of prior therapy\r\n\r\n          -  At least 10 days since prior anticonvulsants for patients in Arm II\r\n\r\n          -  No concurrent investigational agents\r\n\r\n          -  No concurrent ethanol, ephedrine, isoproterenol, epinephrine, tricyclic\r\n             antidepressants, paragyliline, narcotic analgesics, antihistamines, phenothiazines,\r\n             hypotensives, or barbiturates\r\n\r\n          -  At least 14 days since prior antidepressants (e.g., SSRI and/or MAO inhibitor)\r\n\r\n          -  Must avoid foods high in tyramine (i.e., dark beer, wine, yogurt, cheese, bananas)\r\n      ","sponsor":"New Approaches to Brain Tumor Therapy Consortium","sponsor_type":"Other","conditions":"Brain and Central Nervous System Tumors","interventions":[{"intervention_type":"Drug","name":"Drug: procarbazine hydrochloride"}],"outcomes":{}}
{"nct_id":"NCT00507182","start_date":"1999-07-02","phase":"N/A","enrollment":381,"brief_title":"Spectroscopy for Diagnostic Assessment of Oral Mucosal Lesions","official_title":"Fluorescence and Reflectance Spectroscopy for Diagnostic Assessment of Oral Mucosal Lesions","primary_completion_date":"2018-01-12","study_type":"Interventional","rec_status":"Completed","completion_date":"2018-01-12","last_update":"2018-01-19","description":"The goal of this clinical research study is to test a new way to look for cancer and pre-cancerous tissue changes inside the mouth.","other_id":"HNS99-100","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        1. Any person 18 years of age or older with a lesion of the oral mucosa. Persons with\r\n        changes in existing lesions or those who develop new lesions can be re-evaluated, but it is\r\n        not required.\r\n\r\n        Exclusion Criteria:\r\n\r\n        NA\r\n      ","sponsor":"M.D. Anderson Cancer Center","sponsor_type":"Other","conditions":"Oral Cancer","interventions":[{"intervention_type":"Procedure","name":"Procedure: Fluorescence Spectroscopy","description":"1-5 lesions + several normal-looking areas inside the mouth exposed to a beam of light; exposed tissues will emit very small amounts of fluorescence (light) then will be removed."}],"outcomes":[{"outcome_type":"primary","measure":"Classification of Oral Lesions","time_frame":"11 Years","description":"Distinguishing between normal and abnormal sites with four lesion classifications of normal, non-malignant inflammatory, dysplasia, and neoplasia."}]}
{"nct_id":"NCT00205166","start_date":"1999-06-30","phase":"N/A","enrollment":50,"brief_title":"Does Caffeine Affect the Sensitivity of Adenosine Perfusion Scans?","official_title":"Does Caffeine Affect the Sensitivity of Adenosine Perfusion Scans?","primary_completion_date":"2004-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2004-12-31","last_update":"2012-10-29","description":"We are studying the affect of caffeine on the sensitivity of detecting coronary artery disease (blockages in the blood flow to the heart) with adenosine tracer scans. Adenosine is a drug used routinely in patients to relax heart blood vessels in order to assess for the presence of coronary artery disease. Often, if patients have had caffeine, the adenosine scan is not used because of the belief that caffeine may reduce the ability to detect coronary artery disease. We would like to test whether caffeine affects our ability to detect coronary artery disease with adenosine tracer scanning. We will perform an imaging study of the heart with adenosine after you have received caffeine.","other_id":"1999-109","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Diagnostic","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":80,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients who have already completed rest/stress 99mTc sestamibi or 99mTc tetrofosmin\r\n             imaging will be given a form describing this protocol and asked to volunteer for the\r\n             additional scan\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  history of asthma, bronchospastic COPD, or renal failure\r\n      ","sponsor":"University of Wisconsin, Madison","sponsor_type":"Other","conditions":"Coronary Artery Disease","interventions":[{"intervention_type":"Procedure","name":"Procedure: Cardiac SPECT imaging Rest and Stress","description":"adenosine perfusion scintigraphy"},{"intervention_type":"Drug","name":"Drug: Caffeine","description":"Caffeine 400 mg po"},{"intervention_type":"Drug","name":"Drug: Caffeine","description":"Caffeine 200 mg po"}],"outcomes":[{"outcome_type":"primary","measure":"This protocol has a specific aim of determining whether prior caffeine administration affects the sensitivity and specificity of adenosine perfusion scintigraphy for detection of impaired coronary vascular reserve.","time_frame":"Assessment is made at the time of research adenosine perfusion scintigraphy"},{"outcome_type":"secondary","measure":"determination of caffeine levels in patients instructed to hold caffeine prior to adenosine imaging","time_frame":"Assess at time of lab sample results obtained"}]}
{"nct_id":"NCT00004076","start_date":"1999-06-30","phase":"Phase 1","enrollment":30,"brief_title":"PNU 166148 in Treating Patients With Metastatic Solid Tumors","official_title":"A Phase I Study to Evaluate MAG-CPT (PNU 166148) Given as One Single Intravenous Administration Every 4 Weeks in Patients With Advanced Solid Tumors","study_type":"Interventional","rec_status":"Unknown status","last_update":"2013-12-19","description":"RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of PNU 166148 in treating patients who have metastatic solid tumors that have not responded to previous treatment.","other_id":"CDR0000067285","primary_purpose":"Treatment","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        DISEASE CHARACTERISTICS: Histologically proven metastatic, refractory solid tumors for\r\n        which no curative therapy exists No more than 2 prior chemotherapy regimens for metastatic\r\n        disease No prior high dose chemotherapy regimen requiring bone marrow transplantation or\r\n        peripheral blood stem cell transplantation No hematologic malignancies No brain or\r\n        leptomeningeal disease\r\n\r\n        PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life\r\n        expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 2,000/mm3\r\n        Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal (no greater than 1.5 times\r\n        upper limit of normal (ULN) if liver metastases present) SGOT and SGPT normal (no greater\r\n        than 5 times ULN if liver metastases present) Hepatitis B negative Renal: Creatinine less\r\n        than 1.5 mg/dL EDTA clearance greater than 60 mL/min Other: Not pregnant or nursing Fertile\r\n        patients must use effective contraception during and for 6 months after study No severe\r\n        concurrent nonmalignant disease that would preclude protocol therapy HIV negative No AIDS\r\n        related illness No mental incapacity\r\n\r\n        PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 4 weeks\r\n        since prior immunotherapy and recovered No concurrent biological response modifier therapy\r\n        or immunotherapy No concurrent prophylactic growth factors Chemotherapy: See Disease\r\n        Characteristics No prior camptothecins (e.g., irinotecan or topotecan) At least 4 weeks\r\n        since other prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered No\r\n        other concurrent chemotherapy Endocrine therapy: At least 4 weeks since prior hormonal\r\n        therapy and recovered No concurrent corticosteroids used as anticancer therapy No other\r\n        concurrent hormonal therapy Radiotherapy: No prior radiotherapy to greater than 25% of bone\r\n        marrow At least 4 weeks since other prior radiotherapy and recovered No concurrent\r\n        radiotherapy Surgery: Not specified Other: No concurrent investigational drug or\r\n        participation in other clinical study\r\n      ","sponsor":"University of Glasgow","sponsor_type":"Other","conditions":"Unspecified Adult Solid Tumor, Protocol Specific","interventions":[{"intervention_type":"Drug","name":"Drug: mureletecan"}],"outcomes":{}}
{"nct_id":"NCT00001909","start_date":"1999-05-31","phase":"Phase 2","enrollment":40,"brief_title":"Phase II Efficacy Study of Aerosolized Recombinant Human IL-4 Receptor in Asthma","official_title":"Phase II Efficacy Study of Aerosolized Recombinant Human IL-4 Receptor in Asthma","study_type":"Interventional","rec_status":"Completed","completion_date":"2000-05-31","last_update":"2008-03-04","description":"Asthma is a chronic inflammatory disorder of the airways characterized by reversible airflow obstruction. Fourteen million persons (6.4%) in the United States report having asthma, and from 1980 to 1994 the prevalence of self-reported asthma in the United States increased by 75%. A major factor in the pathogenesis of asthma is the development of an allergic inflammatory response to inhaled antigens. Interleukin-4 (IL-4) plays a key role in this response by promoting IgE production, upregulating IgE receptors, upregulating adhesion receptors such as VCAM-1, promoting Th2 cell development and increasing mucus secretion. Soluble recombinantly produced IL-4R (sIL-4R) has been shown to bind and inactivate IL-4, both in vitro and in animal models. As part of a multicenter trial, 20 subjects at the NIH site will receive 0.9 mg., 1.8 mg. sIL-4R or placebo once weekly for 12 weeks in a double blind placebo controlled study. Study drug will be delivered via the AERx aerosol drug delivery device. The primary objective of the study will be to evaluate efficacy as measured by FEV1. Secondary objectives will include changes in FVC, FEF 27-75, peak flow, bronchodilator usage, asthma symptoms, quality of life scores, immunologic and inflammatory markers, pharmacokinetics, safety and immunogenicity. The study population will consist of moderate to severe asthmatics on (Beta)-agonist monotherapy with an FEV1 of 50-80% of predicted. After 12 weeks of study drug, subjects will be followed for an additional 8 weeks.","other_id":"990115","primary_purpose":"Treatment","sampling_method":"","gender":"All","population":"","criteria":"\n        Male or nonpregnant, non-breastfeeding females age 12-85 years.\r\n\r\n        Diagnosis of persistent asthma for greater than 1 year and currently being treated with\r\n        short acting beta-2 agonist only.\r\n\r\n        FEV1 50-80% of predicted (must be demonstrated at Day 10 and Day 0). Patients will be\r\n        stratified into 50-70% or 71-80% cohort at Day 10.\r\n\r\n        Increase of greater than or equal to 15% over baseline FEV1 approximately 15-20 minutes\r\n        after beta-2 agonist inhalation (2-4 puffs of albuterol via MDI or the nebulized\r\n        equivalent) documented at baseline.\r\n\r\n        Positive prick skin test to at least two allergens (defined as wheal 3 mm greater than\r\n        control and erythema greater than control).\r\n\r\n        History of asthma symptoms (wheezing, shortness of breath, cough, chest tightness, or\r\n        nighttime awakening) on least 3 of the last 7 days.\r\n\r\n        Fulfillment of washout criteria by not using any of the medications listed below for the\r\n        specified times prior to Day 0 of the study drug treatment:\r\n\r\n        Parenteral corticosteroids for 4 weeks;\r\n\r\n        Oral corticosteroids for 4 weeks;\r\n\r\n        Inhaled corticosteroids for 4 weeks;\r\n\r\n        Cromolyn sodium (Intal), nedocromil (Tilade) for 4 weeks;\r\n\r\n        Theophylline, zileuton (Zyflo), zafirlukast (Accolate), or montelukast (Singulair) for 4\r\n        weeks;\r\n\r\n        Astemizole (Hismanal) for 12 weeks;\r\n\r\n        Terfenadine (Seldane), or fexofenadine (Allegra) for 6 days;\r\n\r\n        Cetirizine (Zyrtec) for 6 days;\r\n\r\n        Hydroxyzine (Atarax, Vistaril) for 6 days;\r\n\r\n        Azelastine (Astelin) nasal spray for 6 days; and\r\n\r\n        Salmeterol (Serevent) for 9 days.\r\n\r\n        No clinically significant abnormality in chemistry, hematology, urinalysis: serum\r\n        creatinine less than or equal to 1.7 mg/dL; total bilirubin less than or equal to 1.5\r\n        mg/dL; AST (SGOT), ALT (SGPT) less than or equal to 2 times laboratory's upper limit of\r\n        normal.\r\n\r\n        No clinically significant abnormality in EKG within 1 month prior to enrollment.\r\n\r\n        No clinically significant abnormality in CXR (other than changes consistent with asthma)\r\n        within 1 year prior to enrollment.\r\n\r\n        Nonsmoker, for at least 2 years with a smoking history of no more than 10 pack years (e.g.,\r\n        one pack per day for 10 years).\r\n\r\n        Agreement to use medically accepted contraception throughout the study, if sexually active,\r\n        except females who are postmenopausal for greater than or equal to 2 years.\r\n\r\n        Agreement not to donate blood or blood products throughout the study.\r\n\r\n        Demonstrated ability to follow proper technique in the use of the AERx system.\r\n\r\n        A written, signed, and witnessed consent form.\r\n\r\n        No desensitization therapy within 3 months prior to Day 0 of study drug treatment.\r\n\r\n        No use of any investigational or non-approved drug therapy within 30 days prior to Day 0 of\r\n        study drug treatment.\r\n\r\n        No occurrence of acute asthma exacerbation requiring emergency room treatment within 6\r\n        weeks of Day 0 of study drug treatment.\r\n\r\n        No occurrence of acute asthma exacerbation requiring hospitalization within 12 months of\r\n        Day 0 of study drug treatment.\r\n\r\n        No occurrence of respiratory infection which affects asthma within 4 weeks prior to Day 0\r\n        of study drug treatment.\r\n\r\n        No history of endotracheal intubation for asthma-related exacerbation within 15 years prior\r\n        to Day 0 of study drug treatment.\r\n\r\n        No presence of significant medical conditions (including obesity affecting respiratory\r\n        function, congestive heart failure, myocardial infarction, unstable angina, uncontrolled\r\n        hypertension, severe pulmonary disease, history of cancer [other than resected cutaneous\r\n        basal or squamous cell carcinoma], insulin-dependent diabetes, autoimmune disease, or known\r\n        HIV infection).\r\n\r\n        No previous enrollment in a study of soluble IL-4 receptor.\r\n\r\n        No history of alcohol abuse, drug abuse, or psychiatric illness that would interfere with\r\n        ability to comply with protocol requirements or give informed consent.\r\n\r\n        No patients experiencing hypersensitivity to soluble IL-4R.\r\n      ","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","sponsor_type":"NIH","conditions":"Asthma|Hypersensitivity","interventions":[{"intervention_type":"Drug","name":"Drug: Soluble recombinantly produced IL-4R"}],"outcomes":{}}
{"nct_id":"NCT00363116","start_date":"1999-04-30","phase":"Phase 4","enrollment":298,"brief_title":"A Trial of Two Daclizumab Dosing Strategies vs. No Induction Treatment With Tacrolimus, Mycophenolate Mofetil , & Steroids for the Prevention of Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant Recipients","official_title":"An Open-Label, Comparative Trial of Two Daclizumab Dosing Strategies Versus No Induction Treatment in Combination With Tacrolimus, Mycophenolate Mofetil, and Steroids for the Prevention of Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant Recipients","primary_completion_date":"2004-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2004-12-31","last_update":"2013-10-25","description":"The purpose of the study is to determine the safety and efficacy of two dosing regimens of daclizumab in simultaneous kidney/pancreas transplant recipients.","other_id":"ZEN049","allocation":"Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Prevention","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Simultaneous kidney/pancreas transplant recipients\r\n\r\n          -  Insulin dependent Type 1 or 2 diabetes pretransplant\r\n\r\n          -  Recipient age 18-65 years\r\n\r\n          -  Donor age 5-65 years\r\n\r\n          -  Women must have negative serum pregnancy test and practice birth control for study\r\n             duration\r\n\r\n          -  Negative T-cell crossmatch\r\n\r\n          -  Parent (or guardian) is able to understand the consent form and give written informed\r\n             consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Prior treatment with daclizumab\r\n\r\n          -  Known sensitivity or contraindication to tacrolimus, MMF, or steroids\r\n\r\n          -  Patient with significant or active infection\r\n\r\n          -  Patients with a positive lymphocytotoxic crossmatch using donor lymphocytes and\r\n             recipient serum\r\n\r\n          -  Patients whose life expectancy is severely limited by diseases other than renal\r\n             disease\r\n\r\n          -  Ongoing substance abuse, drug or alcohol\r\n\r\n          -  Major ongoing psychiatric illness or recent history of noncompliance\r\n\r\n          -  Insufficient cardiovascular reserve\r\n\r\n          -  Malignancy within last 5 years, excluding nonmelanoma skin cancers\r\n\r\n          -  Serologic evidence of infection with HIV or Hepatitis B surface antigen positive\r\n\r\n          -  Investigational drug within 30 days prior to transplant surgery\r\n\r\n          -  Anti-T cell therapy within 30 days prior to transplant surgery\r\n      ","sponsor":"University of Cincinnati","sponsor_type":"Other","conditions":"Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant Recipients","interventions":[{"intervention_type":"Drug","name":"Drug: Daclizumab","description":"daclizumab 1 mg/kg/dose every 14 days for 5 doses"}],"outcomes":[{"outcome_type":"primary","measure":"To assess the incidence of presumed acute kidney or pancreas rejection, death, and kidney or pancreas graft loss in the first 6 months post transplant."},{"outcome_type":"secondary","measure":"Incidence, timing and severity of fungal infections."},{"outcome_type":"secondary","measure":"Incidence, timing and severity of malignancies."},{"outcome_type":"secondary","measure":"Hospitalizations."}]}
{"nct_id":"NCT00473850","start_date":"1998-12-31","enrollment":2000,"brief_title":"Establishing the Genetic Profile of Multiple Hereditary Exostoses (HME) in Families of BC","official_title":"Establishing the Genetic Profile of Multiple Hereditary Exostoses (HME) in Families of BC","study_type":"Observational","rec_status":"Terminated","completion_date":"2023-03-31","last_update":"2011-04-15","description":"The purpose of this study is to establish the genetic profile of families in British Columbia with HME.","other_id":"H98-70441","observational_model":"Case-Only","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","population":"Benetic profile of families in British Columbia with HME.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Diagnosed with HME\r\n      ","sponsor":"University of British Columbia","sponsor_type":"Other","conditions":"Exostoses, Multiple Hereditary","interventions":{},"outcomes":{}}
{"nct_id":"NCT00003777","start_date":"1998-12-31","phase":"Phase 2","enrollment":35,"brief_title":"Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Recurrent Head and Neck Cancer","official_title":"A Pilot Study of Combined Modality Therapy for Recurrent Head and Neck Carcinoma","study_type":"Interventional","rec_status":"Completed","last_update":"2020-04-16","description":"RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as amifostine may prevent the side effects of radiation therapy. Combining more than one drug and combining radiation therapy and surgery with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining surgery, radiation therapy, and combination chemotherapy in treating patients who have recurrent head and neck cancer that has been treated previously with radiation therapy.","other_id":"CDR0000066906","primary_purpose":"Treatment","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":120,"population":"","criteria":"\n        DISEASE CHARACTERISTICS:\r\n\r\n          -  Histologically confirmed recurrent or new primary squamous cell carcinoma of the head\r\n             and neck occurring in a previously irradiated field\r\n\r\n          -  Pathologic stage of recurrence must be rT3-4 and/or rN2-3\r\n\r\n          -  The following sites are eligible:\r\n\r\n               -  Oral cavity, oropharynx, or hypopharynx: Any rT2-4 and/or clinical rN+\r\n\r\n               -  Larynx: Any rT4, rT3 with perineural invasion, or any rT with clinical rN+\r\n\r\n               -  Any site: Positive margin(s), at least 2 nodes or ECS\r\n\r\n          -  No primary tumor of the nasopharynx\r\n\r\n          -  Must be eligible for or have undergone complete resection which leaves behind no gross\r\n             residual disease\r\n\r\n          -  Must have prior head and neck irradiation of 45-75 Gy\r\n\r\n          -  Lifetime spinal cord radiotherapy dose no greater than 50 Gy\r\n\r\n          -  No ongoing RTOG late morbidity of grade 3 or greater (unless correctable by surgery)\r\n\r\n          -  No active acute radiation mucositis from previous radiotherapy\r\n\r\n        PATIENT CHARACTERISTICS:\r\n\r\n        Age:\r\n\r\n          -  18 and over\r\n\r\n        Performance status:\r\n\r\n          -  Karnofsky 70-100%\r\n\r\n        Life expectancy:\r\n\r\n          -  Not specified\r\n\r\n        Hematopoietic:\r\n\r\n          -  WBC at least 4,000/mm^3\r\n\r\n          -  Hemoglobin at least 9 g/dL (transfusion allowed)\r\n\r\n          -  Platelet count at least 100,000/mm^3\r\n\r\n        Hepatic:\r\n\r\n          -  SGOT or SGPT no greater than 3 times upper limit of normal\r\n\r\n          -  Bilirubin no greater than 2 mg/dL\r\n\r\n        Renal:\r\n\r\n          -  Creatinine no greater than 1.5 mg/dL\r\n\r\n        Cardiovascular:\r\n\r\n          -  No myocardial infarction, unstable angina, coronary heart failure, or uncontrolled\r\n             arrhythmias within past 6 months\r\n\r\n          -  No severe cerebrovascular disease or hypotension not caused by antihypertensive\r\n             medication\r\n\r\n        Other:\r\n\r\n          -  Not pregnant\r\n\r\n          -  Fertile patients must use effective contraception\r\n\r\n          -  No allergy to cisplatin, fluorouracil, or amifostine\r\n\r\n          -  No uncontrolled insulin-dependent diabetes mellitus or other medical condition\r\n             interfering with wound healing\r\n\r\n        PRIOR CONCURRENT THERAPY:\r\n\r\n        Biologic therapy:\r\n\r\n          -  Not specified\r\n\r\n        Chemotherapy:\r\n\r\n          -  No prior chemotherapy for tumor recurrence (except adjuvant chemotherapy)\r\n\r\n        Endocrine therapy:\r\n\r\n          -  Not specified\r\n\r\n        Radiotherapy:\r\n\r\n          -  See Disease Characteristics\r\n\r\n          -  At least 6 months since prior radiotherapy\r\n\r\n          -  Prior radiotherapy treatment records must be available\r\n\r\n        Surgery:\r\n\r\n          -  No prior salvage surgery consisting of partial laryngectomy\r\n      ","sponsor":"Abramson Cancer Center of the University of Pennsylvania","sponsor_type":"Other","conditions":"Head and Neck Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: fluorouracil"},{"intervention_type":"Drug","name":"Drug: amifostine trihydrate"},{"intervention_type":"Drug","name":"Drug: cisplatin"},{"intervention_type":"Procedure","name":"Procedure: surgical procedure"},{"intervention_type":"Radiation","name":"Radiation: radiation therapy"}],"outcomes":{}}
{"nct_id":"NCT02324296","start_date":"1998-12-31","enrollment":46,"brief_title":"PEI REGIMEN: A Therapeutic Option in Small Cell Lung Cancer? A Monoinstitutional Experience of 46 Consecutive Cases","official_title":"PEI REGIMEN: A THERAPEUTIC OPTION IN SMALL CELL LUNG CANCER? A MONOINSTITUTIONAL EXPERIENCE OF 46 CONSECUTIVE CASES","primary_completion_date":"2009-01-31","study_type":"Observational","rec_status":"Completed","completion_date":"2010-12-31","last_update":"2014-12-24","description":"ABSTRACT Objectives Combination chemotherapy is very active in small cell lung cancer (SCLC), although no improvement in overall survival (OS) has been done in the last 25 years , with Cisplatin-Etoposide (PE) still considered the world-wide standard, with an average median survival of about 7-8 months in patients with extended disease (ED). In 1995, a randomized trial of the Hoosier Group in 171 ED patients showed a significant advantage in overall survival in patients treated with PEI (Cisplatin, Etoposide and Ifosfamide), compared to PE. Despite that, PEI regimen has not become a commonly used regimen in SCLC. Materials and Methods Here we present a series of 46 consecutive patients (30 males and 16 females) with SCLC that were treated at our Institution with PEI regimen: Cisplatin 20mg/m2, Etoposide 75mg/m2 and Ifosfamide 1200mg/m2, day 1 to 4, every 3 weeks. Patients received a total of 219 cycles of chemotherapy, with a mean of 4,7 cycles per patient. Median age was 63 (range 59-70); performance status (PS) was 0 in 29 patients (63%), 1 in 13 patients (28%) and 2 in 4 patients (9%).","other_id":"PEI 01","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":75,"population":"All eligible patients had histologically or cytologically proven SCLC, with measurable\r\n        disease defined by RECIST criteria, and received at least one cycle of chemotherapy.\r\n        Patients with central nervous system (CNS) metastases were included in the study.","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  histologically or cytologically proven SCLC\r\n\r\n          -  measurable disease defined by RECIST criteria\r\n\r\n        Exclusion Criteria:\r\n      ","sponsor":"Arcispedale Santa Maria Nuova-IRCCS","sponsor_type":"Other","conditions":"Small Cell Lung Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: ifosfamide","description":"PEI regimen may be a possible therapeutic option, with high activity and an acceptable toxicity profile."}],"outcomes":[{"outcome_type":"primary","measure":"partial response (PR)","time_frame":"1 year"},{"outcome_type":"primary","measure":"complete response (CR)","time_frame":"1 YEAR"},{"outcome_type":"secondary","measure":"Median time to progression (TTP)","time_frame":"1 YEAR"},{"outcome_type":"secondary","measure":"overall survival (OS)","time_frame":"1 YEAR"}]}
{"nct_id":"NCT02018224","start_date":"1998-10-31","phase":"N/A","enrollment":55,"brief_title":"Achilles Tendon Rupture, Comparison Two Different Operative Techniques. Prospective Randomized Controlled Trial. 14 Years Follow-up.","official_title":"Achilles Tendon Rupture, Comparison Two Different Operative Techniques. Prospective Randomized Controlled Trial. 14 Years Follow-up.","primary_completion_date":"2014-03-31","study_type":"Interventional","rec_status":"Completed","last_update":"2014-09-16","description":"The intention is to compare 60 patients with Achilles tendon rupture, who where randomized in 1998-2001 preoperatively to receive end-to-end suturation by the Krackow locking loop technique either without augmentation or with one central down-turned gastrocnemius fascia flap (Silfverskjld). Postoperative care was identical for both groups; A brace allowed free active plantar flexion of the ankle postoperatively, whereas dorsiflexion was restricted to neutral for the first three weeks. Weight bearing was limited for six weeks. To compare these treatments, we use 1998 published Leppilahti-score, Rand-36 quality of life-questionnaire and MRI. Mean follow-up time is 14 years. Hypothesis; Augmentation with a down-turned gastrocnemius fascia flap does not provide better result than would end-to-end suture repair with use of the Krackow locking loop surgical technique in long-term follow up.","other_id":"evo-rad-akilles3","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Total achilles tendon rupture diagnose.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  more than 7 days old rupture, local corticosteroids injection in around the achilles\r\n             tendon, rupture was open/ there where skin problems over achilles tendon area, patient\r\n             lived abroad, if the main author was unavailable, or patient refused to participate.\r\n      ","sponsor":"University of Oulu","sponsor_type":"Other","conditions":"Achilles Tendon Rupture","interventions":[{"intervention_type":"Procedure","name":"Procedure: End-to-end suturation without augmentation","description":"End-to-end suturation without augmentation; Irregular tendon ends were cleaned and repaired by the Krackow technique with two separate 0-gauge absorbable sutures."},{"intervention_type":"Procedure","name":"Procedure: End-to-end suturation with augmentation.","description":"End-to-end suturation with augmentation; End-to-end suturation as above with a 10 mm wide central gastrocnemius aponeurosis flap, as proposed by Silfverskjld."}],"outcomes":[{"outcome_type":"primary","measure":"Subjective results in conservative and operative treatment of Achilles tendon rupture.","time_frame":"14 years","description":"Subjective results consists of Rand-36 questionnaire and part of Leppilahti-scores questionnaire."},{"outcome_type":"primary","measure":"Objective results in operative treatment of Achilles tendon rupture.","time_frame":"14 years","description":"Objective results consists of calf muscle isokinetic strength measurements and MRI-findings."},{"outcome_type":"secondary","measure":"Achilles tendon MRI-findings in operative and conservative treatment of achilles tendon rupture","time_frame":"14 years","description":"We study calf muscle volume, achilles tendon volume, fat degeneration and achilles tendon elongation."}]}
{"nct_id":"NCT01491386","start_date":"1998-08-31","phase":"N/A","enrollment":279,"brief_title":"Pivotal Study of rhBMP-2/ACS/LT-CAGE Device for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease","official_title":"A Clinical Investigation of Recombinant Human Bone Morphogenetic Protein-2 and Absorbable Collagen Sponge With the LT-CAGE Device for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease","primary_completion_date":"2002-10-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2002-10-31","last_update":"2013-08-02","description":"This study is designed to assess the safety and effectiveness of the rhBMP-2/ACS/LT-CAGE device as compared to the LT-CAGE device with autogenous bone in patients with symptomatic degenerative disc disease using an open surgical technique.","other_id":"C-9702","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Has degenerative disc disease as noted by back pain of discogenic origin, with or\r\n             without leg pain, with degeneration of the disc confirmed by patient history (\r\n             e.g.,pain [leg, back, or symptoms in the sciatic nerve distribution], function deficit\r\n             and/or neurological deficit) and radiographic studies ( e.g., CT, MRl, X-Ray, etc.) to\r\n             include one or more of the following:\r\n\r\n               -  instability (defined as angular motion > 5 and/or translation >= 4mm, based on\r\n                  Flex/Ext radiographs);\r\n\r\n               -  osteophyte formation;\r\n\r\n               -  decreased disc height;\r\n\r\n               -  thickening of ligamentous tissue;\r\n\r\n               -  disc degeneration or herniation; and/or\r\n\r\n               -  facet joint degeneration.\r\n\r\n          2. Has preoperative Oswestry score > 35.\r\n\r\n          3. Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification\r\n             (Meyerding HW, 1932.).\r\n\r\n          4. Has single-level symptomatic degenerative involvement from L4 to S1.\r\n\r\n          5. Is at least 18 years of age, inclusive, at the time of surgery.\r\n\r\n          6. Has not responded to non-operative treatment (e.g., bed rest, physical therapy,\r\n             medications, spinal injections, manipulation, and/or TENS) for a period of at least 6\r\n             months.\r\n\r\n          7. If female of child-bearing potential, who is not pregnant or nursing, and who agrees\r\n             to use adequate contraception for 16 weeks following surgery.\r\n\r\n          8. Is willing and able to comply with the study plan and sign the Patient Informed\r\n             Consent Form.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Had previous anterior spinal fusion surgical procedure at the involved level.\r\n\r\n          2. Has posterior spinal instrumentation (which will not be removed) stabilizing the\r\n             involved level or has had a previous posterior lumbar interbody fusion procedure at\r\n             the involved level.\r\n\r\n          3. Has a condition which requires postoperative medications that interfere with fusion,\r\n             such as steroids.\r\n\r\n          4. Has been previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a\r\n             degree that spinal instrumentation would be contraindicated.\r\n\r\n          5. Has presence of active malignancy.\r\n\r\n          6. Has overt or active bacterial infection, either local or systemic.\r\n\r\n          7. ls grossly obese, i.e., weight > 40% over ideal for their age and height.\r\n\r\n          8. Has fever ( temperature > 101 F oral) at the time of surgery.\r\n\r\n          9. Has a documented titanium alloy allergy or intolerance.\r\n\r\n         10. Is mentally incompetent. if questionable, obtain psychiatric consult.\r\n\r\n         11. Has a Waddell Signs of Inorganic Behavior score of 3 or greater.\r\n\r\n         12. Is a prisoner.\r\n\r\n         13. Is an alcohol and/or drug abuser as defined by currently undergoing treatment for\r\n             alcohol and/or drug usage.\r\n\r\n         14. Is a tobacco user at the time of surgery.\r\n\r\n         15. Has received drugs which may interfere with bone metabolism within two weeks prior to\r\n             the planned date of spinal fusion surgery (e.g., steroids or methotrexate).\r\n\r\n         16. Has a history of autoimmune disease (Systemic Lupus Erythematosus or Dermatomyositis).\r\n\r\n         17. Has a history of exposure to injectable collagen implants.\r\n\r\n         18. Has a history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or\r\n             gamma globulins) or collagen.\r\n\r\n         19. Has received treatment with an investigational therapy within 28 days prior to\r\n             implantation surgery or such treatment is planned during the 16 weeks following\r\n             rhBMP-2/ACS implantation.\r\n\r\n         20. Has received any previous exposure to any/all BMP's of either human or animal\r\n             extraction.\r\n\r\n         21. Has a history of allergy to bovine products or a history of anaphylaxis.\r\n\r\n         22. Has history of endocrine or metabolic disorder known to affect osteogenesis (e.g.,\r\n             Paget's disease, renal osteodystrophy, Ehlers- Danlos syndrome, or osteogenesis\r\n             imperfecta).\r\n      ","sponsor":"Medtronic Spinal and Biologics","sponsor_type":"Industry","conditions":"Degenerative Disc Disease","interventions":[{"intervention_type":"Device","name":"Device: rhBMP-2/ACS/LT-CAGE Device","description":"LT-CAGE device with recombinant human bone morphogenetic protein-2 ( rhBMP-2) and the absorbable collagen sponge (ACS)."},{"intervention_type":"Device","name":"Device: Autogenous Bone/LT-CAGE Device","description":"LT-CAGE device with autogenous bone taken from the iliac crest."}],"outcomes":[{"outcome_type":"primary","measure":"Overall success","time_frame":"24 months","description":"A patient will be considered an overall success if all of the following conditions are met:\r\nfusion;\r\npain/disability (Oswestry) improvement;\r\nmaintenance or improvement in neurological status;\r\nno serious adverse event classified as implant associated or implant/surgical procedure associated;\r\nno additional surgical procedure classified as a \"failure.\""},{"outcome_type":"secondary","measure":"Disc Height Measurement","time_frame":"24 months"},{"outcome_type":"secondary","measure":"General Health Status (SF-36)","time_frame":"24 months"},{"outcome_type":"secondary","measure":"Pain Status (Numerical Rating Scale)","time_frame":"24 months"},{"outcome_type":"secondary","measure":"Patient Satisfaction","time_frame":"24 months"},{"outcome_type":"secondary","measure":"Patient Global Perceived Effect","time_frame":"24 months"}]}
{"nct_id":"NCT02265302","start_date":"1998-06-30","phase":"Phase 1","enrollment":95,"brief_title":"Safety, Tolerability, Biological Effects and Pharmacokinetics of BIIL 284 BS in Healthy Males","official_title":"A Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Investigate the Safety, Tolerability, Biological Effects and Preliminary Pharmacokinetics of Increasing Single Oral Doses of BIIL 284 BS (Dose Range: 0.025 mg - 75 mg PSE Solution, 25 mg, 75 mg, 250 mg and 750 mg WIF Tablets) in Healthy Male Volunteers as Well as Food Effects at 75 mg (WIF Tablet)","primary_completion_date":"1998-12-31","study_type":"Interventional","rec_status":"Completed","last_update":"2014-10-15","description":"Study to obtain information about the safety and tolerability of BIIL 248 BS, to find the pharmacologically active dose range for the two formulations PSE 1% and WIF tablets by determination of the surrogate marker CD11b (= Mac-1) and to obtain preliminary pharmacokinetic data as well as first information on food effects after administration of the 75 mg WIF tablet in healthy male volunteers","other_id":"543.1","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"Male","minimum_age":21,"maximum_age":50,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Healthy male subjects as determined by results of screening\r\n\r\n          -  Age  21 and  50 years\r\n\r\n          -  Broca  - 20% and  + 20%\r\n\r\n          -  Signed written informed consent in accordance with Good Clinical Practice and local\r\n             legislation\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Results of the medical examination or laboratory tests that are judged by the clinical\r\n             investigator to differ significantly from normal clinical values\r\n\r\n          -  Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,\r\n             immunological or hormonal disorders\r\n\r\n          -  Diseases of the central nervous system (such as epilepsy) or with psychiatric\r\n             disorders\r\n\r\n          -  Known history of orthostatic hypotension, fainting spells or blackouts\r\n\r\n          -  Chronic or relevant acute infections\r\n\r\n          -  History of allergy/hypersensitivity (including drug allergy) which is deemed relevant\r\n             to the trial as judged by the investigator\r\n\r\n          -  Intake of a drug with a long half-life ( 24 hours) within at least one month or less\r\n             than ten half-lives of the respective drug before enrolment in the study\r\n\r\n          -  Intake of any other drugs which might influence the results of the trial during the\r\n             week previous to the start of the study\r\n\r\n          -  Participation in another study with an investigational drug within the last two months\r\n             preceding this study\r\n\r\n          -  Smokers (> 5 cigarettes or 2 cigars or 2 pipes/day)\r\n\r\n          -  Volunteer who is not able to refrain from smoking on study days\r\n\r\n          -  Alcohol abuse (more than 60 g of alcohol per day)\r\n\r\n          -  Drug abuse\r\n\r\n          -  Excessive physical activities (e.g. competitive sports) within the last week before\r\n             the study\r\n\r\n          -  Blood donation within the last 4 weeks ( 100 ml)\r\n      ","sponsor":"Boehringer Ingelheim","sponsor_type":"Industry","conditions":"Healthy","interventions":[{"intervention_type":"Drug","name":"Drug: BIIL 284 oral solution"},{"intervention_type":"Drug","name":"Drug: BIIL 284 wetability improved formulation (WIF) tablets"},{"intervention_type":"Drug","name":"Drug: Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"Number of subjects with clinically relevant changes in vital signs","time_frame":"up to 8 days after drug administration"},{"outcome_type":"primary","measure":"Number of subjects with clinically relevant changes in electrocardiogram","time_frame":"up to 8 days after drug administration"},{"outcome_type":"primary","measure":"Number of subjects with clinically relevant changes in laboratory parameters","time_frame":"up to 8 days after drug administration"},{"outcome_type":"primary","measure":"Number of subjects with adverse events","time_frame":"up to 8 days after drug administration"},{"outcome_type":"primary","measure":"Determination of surrogate marker cluster of differentiation antigen 11b (CD11b) (=Mac-1)","time_frame":"up to 72 hours after drug administration"},{"outcome_type":"secondary","measure":"Changes in white blood cell count","time_frame":"up to 48 hours after drug administration","description":"determined by flow cytometer"},{"outcome_type":"secondary","measure":"Changes in differential blood cell count","time_frame":"up to 48 hours after drug administration","description":"determined by flow cytometer"},{"outcome_type":"secondary","measure":"Maximum plasma concentration (Cmax)","time_frame":"up to 72 hours after drug administration"},{"outcome_type":"secondary","measure":"Time to reach maximum plasma concentration (tmax)","time_frame":"up to 72 hours after drug administration"},{"outcome_type":"secondary","measure":"Area under the plasma concentration-time curve (AUC) for several time intervals","time_frame":"up to 72 hours after drug administration"},{"outcome_type":"secondary","measure":"Terminal half-life (t1/2)","time_frame":"up to 72 hours after drug administration"},{"outcome_type":"secondary","measure":"Total mean residence time (MRTtot)","time_frame":"up to 72 hours after drug administration"},{"outcome_type":"secondary","measure":"Total clearance after oral administration (CLtot/f)","time_frame":"up to 72 hours after drug administration"},{"outcome_type":"secondary","measure":"Volume of distribution during terminal phase after oral administration (Vz/f)","time_frame":"up to 72 hours after drug administration"}]}
{"nct_id":"NCT00003466","start_date":"1998-03-31","phase":"Phase 2","enrollment":100,"brief_title":"Temozolomide in Treating Patients With Progressive Low-Grade Glioma","official_title":"Phase II Treatment of Adults and Children With Progressive Low Grade Gliomas With Temodal","primary_completion_date":"2005-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2005-07-31","last_update":"2014-07-09","description":"RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with progressive low-grade glioma.","other_id":"1703 (CDR0000066502)","primary_purpose":"Treatment","sampling_method":"","gender":"All","minimum_age":4,"population":"","criteria":"\n        DISEASE CHARACTERISTICS:\r\n\r\n          -  Histologically confirmed progressive, primary, intracranial, supratentorial, low-grade\r\n             glioma including:\r\n\r\n               -  Astrocytoma\r\n\r\n               -  Oligodendroglioma\r\n\r\n               -  Mixed glioma\r\n\r\n               -  Optic pathway glioma*\r\n\r\n               -  Pontine glioma* NOTE: *Biopsy not required\r\n\r\n          -  Patients with optic pathway glioma must also meet the following criteria:\r\n\r\n               -  Progressive loss of vision as defined by doubling of octaves\r\n\r\n               -  Visual acuity loss not explained by other causes\r\n\r\n               -  Increase in proptosis of greater than 3 mm\r\n\r\n               -  Increase in diameter of optic nerve of at least 2 mm on neuroimaging\r\n\r\n               -  Increase in distribution of tumor involving optic tracts or optic radiations as\r\n                  indicated by CT scan or MRI\r\n\r\n        PATIENT CHARACTERISTICS:\r\n\r\n        Age:\r\n\r\n          -  4 and over\r\n\r\n        Performance status:\r\n\r\n          -  Karnofsky 70-100%\r\n\r\n        Life expectancy:\r\n\r\n          -  More than 12 weeks\r\n\r\n        Hematopoietic:\r\n\r\n          -  Absolute neutrophil count at least 1,500/mm^3\r\n\r\n          -  Platelet count at least 100,000/mm^3\r\n\r\n          -  Hemoglobin at least 10 g/dL\r\n\r\n        Hepatic:\r\n\r\n          -  Bilirubin less than 1.5 times upper limit of normal (ULN)\r\n\r\n          -  SGOT and SGPT less than 2.5 times ULN\r\n\r\n          -  Alkaline phosphatase less than 2 times ULN\r\n\r\n        Renal:\r\n\r\n          -  Creatinine less than 1.5 times ULN\r\n\r\n          -  BUN less than 1.5 times ULN\r\n\r\n        Other:\r\n\r\n          -  Must be neurologically stable\r\n\r\n          -  No systemic disease\r\n\r\n          -  No acute infection requiring IV antibiotics\r\n\r\n          -  No frequent vomiting\r\n\r\n          -  No other medical condition that would interfere with oral medication (e.g., partial\r\n             bowel obstruction)\r\n\r\n          -  No other prior or concurrent malignancies except:\r\n\r\n               -  Surgically cured carcinoma in situ of the cervix\r\n\r\n               -  Basal or squamous cell skin cancer\r\n\r\n          -  HIV negative\r\n\r\n          -  No AIDS-related illness\r\n\r\n          -  Not pregnant or nursing\r\n\r\n          -  Fertile patients must use effective contraception\r\n\r\n        PRIOR CONCURRENT THERAPY:\r\n\r\n        Biologic therapy:\r\n\r\n          -  No concurrent biologic therapy (growth factors or epoetin alfa)\r\n\r\n        Chemotherapy:\r\n\r\n          -  At least 6 weeks since prior chemotherapy unless evidence of disease progression\r\n\r\n          -  No other concurrent chemotherapy\r\n\r\n        Endocrine therapy:\r\n\r\n          -  Not specified\r\n\r\n        Radiotherapy:\r\n\r\n          -  At least 6 weeks since prior radiotherapy unless evidence of disease progression\r\n\r\n          -  No concurrent radiotherapy\r\n\r\n        Surgery:\r\n\r\n          -  At least 3 weeks since prior surgery unless evidence of disease progression\r\n\r\n          -  Recovered from all prior surgery\r\n\r\n        Other:\r\n\r\n          -  No other concurrent investigational drugs\r\n      ","sponsor":"Duke University","sponsor_type":"Other","conditions":"Brain and Central Nervous System Tumors","interventions":[{"intervention_type":"Drug","name":"Drug: temozolomide"}],"outcomes":[{"outcome_type":"primary","measure":"Response rate"},{"outcome_type":"primary","measure":"Activity of temozolomide"}]}
{"nct_id":"NCT00003733","start_date":"1997-12-31","phase":"Phase 2","enrollment":40,"brief_title":"Sequential Chemotherapy in Treating Patients With Residual Disease Following Surgery for Stage IIB, Stage III, or Stage IV Ovarian Cancer","official_title":"A Phase II Study of Sequential Carboplatin, Paclitaxel and Hycamtin in Patients With Previously Untreated Advanced Ovarian Cancer","study_type":"Interventional","rec_status":"Unknown status","last_update":"2013-09-20","description":"RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs in different ways may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of sequential chemotherapy in treating patients with residual disease following surgery for stage IIB, stage III, or stage IV ovarian cancer.","other_id":"CDR0000066848","primary_purpose":"Treatment","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        DISEASE CHARACTERISTICS: Histologically confirmed advanced ovarian epithelial carcinoma\r\n        with greater than 1 cm residual disease at completion of initial surgery Stage IIB, IIIA,\r\n        IIIB, IIIC, or IV Measurable disease OR CA 125 greater than 120 units/mL obtained post\r\n        surgery\r\n\r\n        PATIENT CHARACTERISTICS: See General Eligibility Criteria\r\n\r\n        PRIOR CONCURRENT THERAPY: Biological therapy: No prior or concurrent immunotherapy\r\n        Chemotherapy: No prior or concurrent chemotherapy Endocrine: No prior or concurrent\r\n        hormonal therapy Radiotherapy: No prior radiotherapy No concurrent radiotherapy except to\r\n        limited fields (e.g., for palliation of bone pain) Surgery: Diagnostic surgery performed\r\n        less than 12 weeks prior to study No concurrent interval debulking Other: At least 30 days\r\n        or five half-lives since any prior investigational therapy No other concurrent\r\n        investigational therapy --Patients Characteristics-- Age: 18 and over Performance status:\r\n        ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Hemoglobin at least 9.0 g/dL WBC\r\n        at least 4,000/mm3 Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3\r\n        Hepatic: SGOT and/or SGPT no greater than 2.5 times upper limit of normal (ULN) (no greater\r\n        than 5 times ULN if liver metastases present) Alkaline phosphatase no greater than 2.5\r\n        times ULN (no greater than 5 times ULN if liver and/or bone metastases present) Renal:\r\n        Creatine less than 2 times ULN Creatinine clearance at least 50 mL/min Other: No prior\r\n        malignancy except basal cell skin carcinoma or carcinoma in situ of the cervix No\r\n        uncontrolled infection No other concurrent medical conditions that would prevent full\r\n        compliance or expose patient to extreme risk or decreased life expectancy No concurrent\r\n        medical condition for which treament with platinum compounds is contraindicated No history\r\n        of allergy to compounds related to the drugs used in this study No prior motor or sensory\r\n        neurotoxicity grade 2 or worse Not pregnant or nursing Fertile patients must use effective\r\n        contraception\r\n      ","sponsor":"SmithKline Beecham","sponsor_type":"Industry","conditions":"Ovarian Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: carboplatin"},{"intervention_type":"Drug","name":"Drug: paclitaxel"},{"intervention_type":"Drug","name":"Drug: topotecan hydrochloride"}],"outcomes":{}}
{"nct_id":"NCT00001724","start_date":"1997-11-30","phase":"Phase 2","enrollment":100,"brief_title":"Local Flurbiprofen to Treat Pain Following Wisdom Tooth Extraction","official_title":"Evaluation of the Analgesic Effects of Locally Applied Flurbiprofen and Bupivacaine in the Oral Surgery Model","study_type":"Interventional","rec_status":"Completed","completion_date":"2001-11-30","last_update":"2008-03-04","description":"This study will evaluate the effectiveness of the non-steroidal anti-inflammatory drug flurbiprofen (Ansaid (Registered Trademark)) in relieving pain following oral surgery. Flurbiprofen is approved by the Food and Drug Administration for treatment of arthritis pain. Patients 16 years of age and older requiring third molar (wisdom tooth) extraction may be eligible for this study. Patients will undergo oral surgery to remove two lower third molar teeth. Before surgery, they will be given a local anesthetic (lidocaine with epinephrine) injected in the mouth and a sedative (Versed) infused through a catheter (thin plastic tube) placed in an arm vein. At the time of surgery, patients will also be given flurbiprofen or a placebo formulation (look-alike substance with no active ingredient) directly into the extraction site and a capsule that also may contain flurbiprofen or placebo. One in seven patients will receive only placebo. All patients will fill out pain questionnaires and stay in the clinic for up to 6 hours for observation of bleeding and medication side effects. Patients who do not have satisfactory pain relief from the test medicine after surgery may request a standard pain reliever. A small blood sample will be collected during surgery and at 15 minutes, one-half hour and 1, 2, 3, 4, 5, 6, 24 and 48 hours after surgery to measure flurbiprofen blood levels. A total of 33 ml (about 2 tablespoons) of blood will be drawn for these tests. Samples collected on the day of surgery will be drawn from the catheter used to administer the sedative; the 24- and 48-hour samples will be taken by needle from an arm or hand vein. Urine samples will also be collected between 4 and 6 hours after surgery and again at 24 and 48 hours after surgery.","other_id":"980035","primary_purpose":"Treatment","sampling_method":"","gender":"All","population":"","criteria":"\n        Patients of either sex requiring removal of two impacted mandibular third molars (partial\r\n        bony or soft tissue impaction).\r\n\r\n        16 years of age of older.\r\n\r\n        Indicates willingness to undergo oral surgery with local anesthesia and intravenous\r\n        midazolam only.\r\n\r\n        Willing to return for the removal of the remaining maxillary third molars at a second\r\n        appointment.\r\n\r\n        Patients with a history of allergy to flurbiprofen, aspirin, or any NSAID will be excluded.\r\n\r\n        Those with a history of aspirin or NSAID-induced asthma will be excluded.\r\n\r\n        Females of childbearing potential who are not practicing adequate contraception will be\r\n        excluded.\r\n\r\n        Pregnant or nursing females will be excluded.\r\n\r\n        Patients with recent history or present signs of renal, hepatic, endocrine, pulmonary,\r\n        cardiac, gastrointestinal, neurologic, or cerebral function impairment will be excluded.\r\n\r\n        Those with psychiatric disorders will be excluded.\r\n\r\n        Patients who have taken an investigational drug within 30 days of this study will be\r\n        excluded.\r\n\r\n        Those who have taken another analgesic, steroid, opioid, or NSAID within 24 hours prior to\r\n        the study will be excluded.\r\n\r\n        Those with an absence of bilateral local anesthesia during surgery as evidenced by\r\n        anesthesia or paresthesia of the lower lip postoperatively will be excluded.\r\n\r\n        Patients who use drugs which will interact with NSAID such as aspirin, warfarin,\r\n        probenecid, methotrexate, lithium and diuretics will be excluded.\r\n      ","sponsor":"National Institute of Dental and Craniofacial Research (NIDCR)","sponsor_type":"NIH","conditions":"Pain","interventions":[{"intervention_type":"Drug","name":"Drug: Flurbiprofen"}],"outcomes":{}}
{"nct_id":"NCT00198718","start_date":"1997-11-30","phase":"Phase 2","enrollment":28220,"brief_title":"Single-dose Postpartum Vitamin A Supplementation of Mothers and Neonates","official_title":"Vitamin A Supplementation of Breast Feeding Mothers and Their Neonates at Delivery: Impact on Mother to Child Transmission of HIV During Lactation, HIV Infection Among Women During the Postpartum Year, and Infant Mortality.","primary_completion_date":"2001-05-31","study_type":"Interventional","rec_status":"Unknown status","completion_date":"2020-05-31","last_update":"2018-08-08","description":"The ZVITAMBO PROJECT is testing whether giving mothers and infants a single large dose of vitamin A during the immediate post partum period will reduce: 1. Infant Mortality Can oral administration of a single 50,000 IU dose of vitamin A to newborn infants, a single 400,000 IU dose of vitamin A given to their lactating mothers, or supplementation of both the mother and infant during the immediate post partum period reduce infant mortality by at least 30%? 2. Mother to Child HIV transmission during breast feeding Can oral administration of a single large dose of vitamin A given during the immediate post partum period to HIV seropositive lactating women and/or their babies reduce HIV transmission via breast feeding by at least 30%? 3. Sexually transmitted HIV infection of post partum women Can a single 400,000 IU dose of vitamin A given during the immediate post partum period to HIV seronegative women reduce their likelihood of becoming HIV infected during the post partum year by at least 25%? 4. Infant feeding in the context of HIV: An operational research study was initiated mid-way through the trial to determine how UNAIDS Guidelines on infant feeding in the context of HIV could be effectively implemented and to measure the impact of such a program on infant feeding practices and postnatal HIV transmission. Substudies: Random subsamples of maternal and infant blood were evaluated for anemia and iron status to determine the effect of vitamin A on hematopoiesis and serum and breast milk retinol (mothers) and modified relative dose response test (infants) to determine the effect of vitamin A on vitamin A status. A subsample of maternal and infant blood samples were evaluated for the presence of HLA-E, HLA-G, and TAP polymorphisms and their relation to prevalent HIV infection in mothers and risk of mother to child transmission.","other_id":"(CIDA) (R/C Project 690/M3688)","allocation":"Randomized","intervention_model":"Factorial Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  mothers and their neonates delivering at a study recruitment site during the\r\n             recruitment period\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  mother in intensive care unit\r\n\r\n          -  mother not fully conscious\r\n\r\n          -  maternal temperature > 39\r\n\r\n          -  Mother is 'nil per mouth' (NPO)\r\n\r\n          -  Mother is terminally ill as indicated in medical notes\r\n\r\n          -  Infant is NPO\r\n\r\n          -  Infant is terminally ill as indicated in medical notes\r\n\r\n          -  Infant birth weight <1500 g\r\n\r\n          -  Infant is a twin or triplet delivery\r\n\r\n          -  Regular place of residence is outside Harare.\r\n      ","sponsor":"Johns Hopkins Bloomberg School of Public Health","sponsor_type":"Other","conditions":"Vitamin A Deficiency|HIV","interventions":[{"intervention_type":"Drug","name":"Drug: Vitamin A (retinyl palmitate)"}],"outcomes":[{"outcome_type":"primary","measure":"1. HIV infection rate among baseline HIV-negative babies born to HIV-positive mothers at 24 months","time_frame":"By 24 months of age"},{"outcome_type":"primary","measure":"2. Infant mortality rate among all infants, infants born to HIV-negative mothers, and infants born to HIV-positive mothers at 6 months","time_frame":"by 12 months of age"},{"outcome_type":"primary","measure":"3. HIV infection rates among baseline HIV-negative mothers at 24 months","time_frame":"by 24 months postpartum"},{"outcome_type":"secondary","measure":"1. HIV infection or death rate among baseline HIV-negative babies born to HIV-positive mothers at 6, 12, and 18 months","time_frame":"By 24 months of age"},{"outcome_type":"secondary","measure":"2. HIV infection or death rate among 6-wk HIV-negative babies born to HIV-positive mothers at 6, 12, 18, 24 months","time_frame":"by 24 months of age"},{"outcome_type":"secondary","measure":"3. Serum and breast milk retinol concentration among women at 12 months","time_frame":"12 months postpartum"},{"outcome_type":"secondary","measure":"4. Modified relative dose response ratios among infants at 6 wk, and 3, 6, 9, and 12 months.","time_frame":"12 months post partum"},{"outcome_type":"secondary","measure":"5. Viral load among HIV-positive women at 6 wk, and 3, 6, 9, and 12 months.","time_frame":"12 months postpartum"},{"outcome_type":"secondary","measure":"6. Weight for age among infants at 12 months","time_frame":"12 months of age"},{"outcome_type":"secondary","measure":"7. Weight for length among infants at 12 months","time_frame":"12 months of age"},{"outcome_type":"secondary","measure":"8. Length for age among infants at 12 months","time_frame":"12 months of age"}]}
{"nct_id":"NCT00000381","start_date":"1997-06-30","phase":"Phase 3","brief_title":"Fluoxetine for Anxious Children","primary_completion_date":"2003-05-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2003-05-31","last_update":"2014-01-08","description":"The purpose of this study is to see if it is safe and effective to use fluoxetine to treat children and adolescents with Generalized Anxiety Disorder (GAD). Anxiety disorders are one of the most common psychiatric disorders in children and adolescents, and can cause disturbances in the child's school, social, and family lives. Having an anxiety disorder puts a child at risk for depression and drug abuse, and appears to continue into adulthood. There is very little information on anxiety medications for children. Children will be assigned randomly (like tossing a coin) to receive either fluoxetine or an inactive placebo for 12 weeks. Each child will be monitored for symptoms and side effects throughout the study. He/she will have blood tests at Weeks 4, 8, and 12 to measure drug levels in the blood. The study will last for 12 weeks. A child is eligible for this study if he/she: Is 8 to 17 years old and has anxiety disorder. A child will not be eligible for this study if he/she: Has current major depression, panic disorder, or obsessive-compulsive disorder, or abuses alcohol or drugs.","other_id":"R01MH053681","allocation":"Randomized","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":8,"maximum_age":17,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n        -\r\n\r\n        Patients must have:\r\n\r\n        Generalized anxiety disorder.\r\n\r\n        Exclusion Criteria:\r\n\r\n        -\r\n\r\n        Excluded:\r\n\r\n        Patients with current major depression, as well as patients with panic and\r\n        obsessive-compulsive disorder.\r\n\r\n        -\r\n\r\n        Excluded:\r\n\r\n        Current substance abuse.\r\n      ","sponsor":"University of Pittsburgh","sponsor_type":"Other","conditions":"Anxiety Disorders","interventions":[{"intervention_type":"Drug","name":"Drug: Fluoxetine"}],"outcomes":{}}
{"nct_id":"NCT00011258","start_date":"1997-03-31","enrollment":1000,"brief_title":"Paraoxonase and LDL Oxidation in Carotid Artery Disease","official_title":"Paraoxonase and LDL Oxidation in Carotid Artery Disease","study_type":"Observational","rec_status":"Completed","completion_date":"2003-09-30","last_update":"2009-01-21","description":"Atherosclerosis of the carotid arteries is a common cause of stroke. The prevalence and progression of carotid atherosclerosis are believed to be influenced by genetically inherited variations in lipoprotein metabolism. This study investigates the specific role of paraoxonase, an enzyme thought to detoxify atherogenic oxidized low-density lipoprotein. This study compares veterans who have significant carotid atherosclerosis on ultrasound examination with controls without carotid atherosclerosis. Both paraoxonase activity and genotype will be determined and compared between groups. The results may eventually make it possible to screen for a paraoxonase allele that confers high risk of atherosclerosis, and to diminish the risk by early treatment.","other_id":"S006","sampling_method":"","gender":"All","population":"","criteria":"\n        Case: Either had a history of surgical carotid endarterectomy or carotid or CT angiogram\r\n        showing greater than or equal to 80% stenosis in one or more internal carotid artery.\r\n        Control: An ultrasound documenting internal carotid artery stenosis less than 15%\r\n        bilaterally.\r\n      ","sponsor":"US Department of Veterans Affairs","sponsor_type":"U.S. Fed","conditions":"Carotid Stenosis","interventions":[{"intervention_type":"Drug","name":"Drug: Paraoxonase"}],"outcomes":{}}
{"nct_id":"NCT00001610","start_date":"1997-02-28","enrollment":150,"brief_title":"Normal Human Electro-Oculogram","official_title":"Normal Human Electro-Oculogram","study_type":"Observational","rec_status":"Completed","completion_date":"2003-03-31","last_update":"2008-03-04","description":"This study will measure the normal range of the human electro-oculogram (EOG) in people of various age groups. EOGs are recordings of electrical signals generated by the retina (the light-sensitive tissue in the back of the eye) when going from a dark to a bright environment. They provide valuable information about the function of the eye in health and disease. A knowledge of what results are to be expected in tests of normal, healthy eyes will be valuable in assessing EOG results in patients with known or suspected retinal diseases. Normal volunteers from ages 6 to 65 who have healthy eyes and normal eyesight will participate in this study. Candidates will undergo tests to check vision and the health of the eye. Study participants will then have an electro-oculogram. In this test, eye drops are placed in the eye to enlarge the pupils. Two electrodes (small disks that picks up electrical signals) are attached to the left and right of each eye and one to the forehead. (These are similar to electrodes placed on the body during an electrocardiogram (ECG), which measures electrical signals from the heart.) During the EOG recording, the volunteer looks at the inside of a hollow sphere, following with their eyes small red lights that turn on and off. The background light is also turned on or off during the test. Some volunteers may be asked to repeat the EOG at another time. Study participants may also be asked to provide a blood sample for tests to study how the immune cells in the blood respond to proteins found in the retina. The response from normal volunteers will be compared with that of patients with eye diseases like retinitis pigmentosa.","other_id":"970080","sampling_method":"","gender":"All","population":"","criteria":"\n        Subjects must have best corrected visual acuity equal or better than 20/20.\r\n\r\n        Subjects must have normal visual fields.\r\n\r\n        Subjects must have normal color vision.\r\n\r\n        Subjects must have a normal ophthalmological exam.\r\n\r\n        Subjects should not be subjective to or objective evidence of visual loss.\r\n\r\n        Subjects cannot have subjective evidence of abnormal night vision or subjective evidence of\r\n        abnormal light sensitivity.\r\n\r\n        Subjects cannot have a personal history of non-trivial ocular disease.\r\n\r\n        Subjects cannot have a family history of hereditary ocular disease.\r\n\r\n        Subjects cannot have current systemic disease.\r\n\r\n        Subjects cannot currently take neuropharmacological medication.\r\n\r\n        Subjects will not be admitted with an abnormal ophthalmological examination.\r\n\r\n        Subjects will need the ability to cooperate with EOG recording.\r\n      ","sponsor":"National Eye Institute (NEI)","sponsor_type":"NIH","conditions":"Healthy","interventions":{},"outcomes":{}}
{"nct_id":"NCT04514575","start_date":"1997-01-01","enrollment":17000,"brief_title":"Plasma Transfusion in Major Vascular Surgery","official_title":"Plasma Transfusion in Major Vascular Surgery: a Danish Nationwide Registry Study","primary_completion_date":"2018-12-31","study_type":"Observational","rec_status":"Completed","completion_date":"2018-12-31","last_update":"2021-01-28","description":"BACKGROUND - Major blood loss is frequent in open repair of ruptured and intact abdominal aortic aneurysm (AAA) as well as in aorto-bifurcated prosthesis insertion due to aortoiliac occlusive disease. - Major blood loss is associated with death, post-operative complications and coagulopathy. - Data from randomized trials in trauma patients indicate that a high plasma to red blood cell (RBC) transfusion ratio reduces 30-day mortality. - No randomized trial data are available for the AAA population. - Observational data demonstrate, that a high plasma:RBC transfusion ratio associates to a lower 30 day mortality. However, the reports are based on small cohorts of 78-165 patients, short term outcomes and lack information on major adverse events such as cardiac and respiratory. - The Danish Vascular Registry (DVR), covering 1996-2018, contains data on approx. 4,400 ruptured and 8,200 intact (elective/symptomatic) AAA repairs, and 5,400 open aortoiliac repairs due to occlusive disease. Expected total count 1997-2018: 17,000. - The Danish Transfusion Database (DTDB), covering approx. 1997-2018, contains information on units of RBCs, plasma and platelets transfused. A unique patient identification number (CPR) allows merging of all data set. OBJECTIVE To identify whether resuscitation with a high plasma to RBC ratio associates to improves survival in open abdominal aortic surgery as compared to a low plasma to RBC-ratio. PICO - Population: Open abdominal aortic surgery - Intervention: \"High FFP\": FFP to RBC unit ratio of 2:3 to 3:3 (0.7 - 1.0) - Comparison: \"Low FFP\": FFP to RBC unit ratio of 0:3 to 1:3 (0.0 - 0.3) - Outcome: All-cause mortality 90 days following surgery. DATA SOURCES CPR, Danish Civil Registration System. DNPR, Danish National Patient registry. DVR, Danish Vascular registry. DPDB, The Danish national Prescription DataBase.","other_id":"REG-144-2017","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Probability Sample","gender":"All","minimum_age":41,"maximum_age":99,"population":"In Denmark, every citizen is registered with a unique identification number in the Civil\r\n        Registration System. Patients undergoing major open abdominal aortic surgery (above 40 and\r\n        below 100 years of age) registered in the Danish Vascular Registry in the period between\r\n        January 1st 1997 and December 31st 2018 will be identified and linked to national health\r\n        registers by using the unique identification number. The DTDB will provide data on blood\r\n        transfusions. The DNPR will provide data on complications by ICD10 code and on hospital\r\n        admission duration.\r\n\r\n        Data sources CPR, Danish Civil Registration System. DNPR, Danish National Patient registry.\r\n        DVR, Danish Vascular registry. DPDB, The Danish national Prescription DataBase.","criteria":"\n        Inclusion Criteria:\r\n\r\n          1. Open abdominal aortic repair with the insertion of prosthesis for either\r\n\r\n               -  intact (elective or symptomatic) AAA\r\n\r\n               -  ruptured AAA\r\n\r\n               -  aorto-iliac occlusive disease\r\n\r\n          2. Requiring massive transfusion defined as 10 units or more of any blood product(*)\r\n             transfused on the same date (source DTDB)\r\n\r\n        (*) = Allogeneic packed RBCs, FFP, cryoprecipitate, or platelets. Cryoprecipitate will\r\n        account for 4 units of FFP in the FFP:RBC ratio.\r\n\r\n        Exclusion Criteria:\r\n\r\n          1. Surgery time limited to < 50 minutes (DVR)\r\n\r\n          2. No prosthesis inserted (DVR) AND operation date (DVR) equal to the death date (CPR)\r\n\r\n        Excluding patients with surgery time less than 50 minutes or cases where no prosthesis has\r\n        been inserted is expected to minimize survival bias from patients exsanguinating in the\r\n        operation theater before blood products can be delivered. Intentionally, it may also\r\n        exclude cases where surgery was considered futile and halted.\r\n      ","sponsor":"Naestved Hospital","sponsor_type":"Other","conditions":"Aortic Aneurysm, Abdominal|Arterial Occlusive Diseases","interventions":[{"intervention_type":"Biological","name":"Biological: Plasma transfusion","description":"Transfusion of allogeneic fresh frozen plasma or cryoprecipitate"}],"outcomes":[{"outcome_type":"primary","measure":"90-day survival","time_frame":"First 90 days after index surgery","description":"Survival data. Source: CPR"},{"outcome_type":"secondary","measure":"30-day survival","time_frame":"First 30 days after index surgery","description":"Survival data. Source: CPR"},{"outcome_type":"secondary","measure":"1-year survival","time_frame":"1 year after index surgery","description":"Survival data. Source: CPR"},{"outcome_type":"secondary","measure":"Death or any major adverse events at 90-days","time_frame":"First 90 days after index surgery","description":"Dichotomous outcome. Source: DNPR and DVR.\r\nA. Major adverse cardiovascular events \"MACE\" [ICD10-codes]\r\nacute myocardial infarction [DI21.0-23.9, DT817Y2]\r\nstroke [DI60-64.9, DT817Y1]\r\nnon-fatal cardiac arrest [DI460]\r\nB. Major adverse respiratory events\r\nadult respiratory distress syndrome [DJ80]\r\npulmonary edema [DJ81]\r\npulmonary embolism [DI26, DT817D]\r\nC. Major adverse vascular event\r\nbowel ischemia [DK550C-H]\r\nvascular reoperation for deep rebleeding or thrombus or embolus [KPWE, KPWG], lower-limb fasciotomy [KNGM09, KNHM09, KNFM09] or explorative laparotomy [KJAH00]\r\nmajor lower limb amputation [KNE-HQ]\r\nacute limb ischemia requiring intervention\r\nD. Other\r\nrenal replacement therapy [BJFD, DZ992]\r\nAB0-incompatibility reaction [DT803]\r\nRhesus-incompatibility reaction [DT804]\r\nHemorrhage and hematoma complicating a procedure, not elsewhere classified [T810, DT810G, DT810E]"},{"outcome_type":"secondary","measure":"Number of days alive outside hospital within 90 days","time_frame":"Day 90 after index surgery","description":"Count data. Source: DNPR and CPR"}]}
{"nct_id":"NCT00186680","start_date":"1996-09-30","phase":"Phase 1/Phase 2","enrollment":99,"brief_title":"CD34 Selection of the Peripheral Blood Stem Cell Graft for Autologous Transplant","official_title":"Selection of CD34+THY-1 Positive Cells From Peripheral Blood Cells Procured for Autologous Hematopoietic Support Following High Dose Treatment With BCNU, Cyclophosphamide & Cisplatin for Stage IV Breast Cancer & Limited Prior Treatment","primary_completion_date":"2005-06-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2005-06-30","last_update":"2010-03-02","description":"Evaluate the feasibility and safety of autologous transplantation of CD34+Thy-1+ hematopoietic stem cells afer high dose marrow ablative chemotherapy in patients with breast cancer.","other_id":"BMT86","allocation":"Non-Randomized","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":19,"maximum_age":70,"population":"","criteria":"\n        Inclusion Criteria:- stage IV breast cancer\r\n\r\n          -  primary breast cancer does not express CD34+\r\n\r\n          -  adequate organ function\r\n\r\n          -  no evidence of active infection Exclusion Criteria:- chemotherapy within 4 weeks\r\n\r\n          -  CNS disease\r\n      ","sponsor":"Stanford University","sponsor_type":"Other","conditions":"Breast Cancer","interventions":[{"intervention_type":"Procedure","name":"Procedure: high dose chemo then auto hematopoietic cell transplant"}],"outcomes":[{"outcome_type":"primary","measure":"Feasibility and safety"},{"outcome_type":"secondary","measure":"efficiency of mobilization"},{"outcome_type":"secondary","measure":"tumor contamination"}]}
{"nct_id":"NCT00001512","start_date":"1996-09-09","phase":"Phase 1","enrollment":42,"brief_title":"Active Specific Immunotherapy for Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines","official_title":"Active Specific Immunotherapy for Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines","primary_completion_date":"2010-03-05","study_type":"Interventional","rec_status":"Completed","completion_date":"2010-03-05","last_update":"2017-07-02","description":"The idiotype of the immunoglobulin on a given B cell malignancy (Id) can serve as a clonal marker, and a previous pilot study in lymphoma patients has demonstrated that autologous Id protein can be formulated into an immunogenic, tumor specific antigen by conjugation to a carrier protein (KLH) and administration with an emulsion-based adjuvant. The goals of vaccine development in the current study are to develop vaccines: 1) with improved potency and 2) which are more effective at inducing cell-mediated immune responses. The selection of GM-CSF as the immunological \"adjuvant\" is a direct extension of our laboratory studies in small animal models demonstrating that GM-CSF can enhance the potency of the prototype Id-KLH vaccine by augmenting almost exclusively the cellular arm of the immune response. The objectives of this study are: 1) to evaluate cellular and humoral immune responses against the unique idiotype of the patient's lymphoma and 2) to evaluate the ability of the Id vaccine to clear the bone marrow of malignant cells detectable by pathologic examination or molecular examination (polymerase chain reaction amplification of the rearranged bcl-2 oncogene). The goal of this study is to treat previously untreated patients with follicular lymphomas to complete remission or minimal residual disease with ProMACE chemotherapy. Three to six months after completion of chemotherapy, in an effort to reduce the relapse rate (by eradicating microscopic disease resistant to chemotherapy), patients will receive an autologous Id vaccine administered in combination with GM-CSF. Id-KLH (0.5 mg) is administered subcutaneously. GM-CSF is administered subcutaneously locally with the vaccine on the day of vaccination and for the three consecutive days following vaccination as close to the initial vaccination site as possible at one of two doses (patients are randomized to either a high or low dose, 500 or 100 micrograms/m2). We plan to accrue 42 patients. Twenty-nine patients have been enrolled. Sixteen patients have entered and/or completed the vaccination phase. Patients have demonstrated significant lymphoproliferative responses specific for autologous idiotype of a magnitude which is significantly greater than previously observed.","other_id":"960133","primary_purpose":"Treatment","sampling_method":"","gender":"All","minimum_age":18,"population":"","criteria":"\n        -  INCLUSION CRITERIA:\r\n\r\n        Patients must meet all of the following eligibility criteria.\r\n\r\n        Tissue diagnosis of: follicular small cleaved cell, or follicular mixed lymphoma with\r\n        surface IgM, IgG or IgA phenotype with a monoclonal heavy and light chain. Pathology slides\r\n        must be submitted to the NIH Pathology Department for review.\r\n\r\n        Stage III or IV lymphoma.\r\n\r\n        Only previously untreated patients are eligible.\r\n\r\n        Previous treatment with radiation alone (less than TBI) is permissible.\r\n\r\n        A single peripheral lymph node of at least 2 cm size accessible for biopsy/harvest.\r\n\r\n        Karnofsky status greater than or equal to 70 percent.\r\n\r\n        Life expectancy of greater than 1 year.\r\n\r\n        Serum creatinine less than or equal to 1.5 mg per dl unless felt to be secondary to\r\n        lymphoma.\r\n\r\n        Bilirubin less than or equal to 1.5 mg/dl unless felt to be secondary to lymphoma or\r\n        Gilbert's disease. SGOT/SGPT less than or equal to 3.5 times upper limit of normal.\r\n\r\n        Ability to give informed consent. Ability to return to clinic for adequate follow-up for\r\n        the period that the protocol requires.\r\n\r\n        EXCLUSION CRITERIA:\r\n\r\n        Prior total body irradiation.\r\n\r\n        Presence of antibodies to HIV, hepatitis B surface antigen or other active infectious\r\n        process.\r\n\r\n        Pregnancy or lactation. Fertile men and women must plan to use effective contraception. A\r\n        beta-HCG level will be obtained in women of child-bearing potential.\r\n\r\n        Patients with previous or concomitant malignancy, regardless of site, except curatively\r\n        treated squamous or basal cell carcinoma of the skin, or effectively treated carcinoma in\r\n        situ of the cervix.\r\n\r\n        Patients unwilling to give informed consent.\r\n\r\n        Failure to meet any of the inclusion criteria.\r\n\r\n        Any medical or psychiatric condition that in the opinion of the protocol chairman would\r\n        compromise the patient's ability to tolerate this treatment will be excluded from this\r\n        protocol.\r\n\r\n        Patient with CNS lymphoma (current or previously treated) will not be eligible.\r\n      ","sponsor":"National Cancer Institute (NCI)","sponsor_type":"NIH","conditions":"B Cell Lymphoma|Follicular Lymphoma|Lymphoma","interventions":[{"intervention_type":"Drug","name":"Drug: Id-KLH Vaccine"},{"intervention_type":"Drug","name":"Drug: GM-CSF"}],"outcomes":{}}
{"nct_id":"NCT00002798","start_date":"1996-08-31","phase":"Phase 3","enrollment":880,"brief_title":"Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myelogenous Leukemia or Myelodysplastic Syndrome","official_title":"A PHASE III STUDY IN CHILDREN WITH UNTREATED ACUTE MYELOGENOUS LEUKEMIA (AML) OR MYELODYSPLASTIC SYNDROME (MDS)","primary_completion_date":"2006-09-30","study_type":"Interventional","rec_status":"Completed","last_update":"2013-01-16","description":"Randomized phase III trial to compare the effectiveness of different chemotherapy regimens with or without bone marrow transplantation in treating children who have acute myelogenous leukemia or myelodysplastic syndrome. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known which treatment regimen is more effective for acute myelogenous leukemia or myelodysplastic syndrome","other_id":"NCI-2012-01834","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","maximum_age":21,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Histologically confirmed previously untreated acute myeloid leukemia (AML) in patients\r\n             1 month to 21 years of age\r\n\r\n               -  Infants under 1 month with progressive disease eligible\r\n\r\n                    -  Supportive care may be given to confirm that the leukemia is not regressing\r\n                       prior to entry\r\n\r\n               -  No acute promyelocytic leukemia (FAB M3)\r\n\r\n               -  No acute undifferentiated leukemia (FAB M0)\r\n\r\n          -  Histochemical verification of AML required by the following stains:\r\n\r\n               -  Wright or Giemsa\r\n\r\n               -  Peroxidase\r\n\r\n               -  PAS\r\n\r\n               -  Chloroacetate esterase\r\n\r\n               -  Sudan black\r\n\r\n               -  Nonspecific esterase (NSE) with and without fluoride (NaF) inhibition\r\n\r\n               -  Combined NSE/NaF and butyrate inhibition or diagnosis of megakaryoblasticleukemia\r\n                  (FAB M7) should be supported by one of the following:\r\n\r\n                    -  CD41 reactivity\r\n\r\n                    -  Glycoprotein 1b reactivity\r\n\r\n                    -  Factor VIII-related antigen reactivity\r\n\r\n                    -  Platelet peroxidase on electron microscopy\r\n\r\n          -  The following are also eligible:\r\n\r\n               -  Myelodysplastic syndromes, including:\r\n\r\n                    -  Refractory anemia (RA) *\r\n\r\n                    -  RA with ringed sideroblasts (RARS) *\r\n\r\n                    -  RA with excess blasts (RAEB)\r\n\r\n                    -  RAEB in transformation (RAEBt)\r\n\r\n                    -  Chronic myelomonocytic leukemia (CMML)\r\n\r\n               -  AML with monosomy 7\r\n\r\n               -  Granulocytic sarcoma (chloroma) with or without marrow involvement\r\n\r\n               -  Mixed lineage leukemia with 2 morphologically defined populations provided the\r\n                  predominant population is myeloid\r\n\r\n          -  No Downs syndrome\r\n\r\n          -  No juvenile chronic myelogenous leukemia\r\n\r\n          -  No Fanconi's anemia\r\n\r\n          -  No secondary AML\r\n\r\n          -  Performance status - Not specified\r\n\r\n          -  No prior anticancer chemotherapy\r\n\r\n          -  Prior topical or inhaled steroids for nonmalignant conditions allowed\r\n\r\n          -  No prior anticancer radiotherapy\r\n\r\n          -  No prior antileukemic therapy\r\n      ","sponsor":"National Cancer Institute (NCI)","sponsor_type":"NIH","conditions":"Childhood Acute Erythroleukemia (M6)|Childhood Acute Megakaryocytic Leukemia (M7)|Childhood Acute Monoblastic Leukemia (M5a)|Childhood Acute Monocytic Leukemia (M5b)|Childhood Acute Myeloblastic Leukemia With Maturation (M2)|Childhood Acute Myeloblastic Leukemia Without Maturation (M1)|Childhood Acute Myelomonocytic Leukemia (M4)|Childhood Myelodysplastic Syndromes|Chronic Myelomonocytic Leukemia|de Novo Myelodysplastic Syndromes|Refractory Anemia|Refractory Anemia With Excess Blasts|Refractory Anemia With Excess Blasts in Transformation|Refractory Anemia With Ringed Sideroblasts|Secondary Myelodysplastic Syndromes|Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies","interventions":[{"intervention_type":"Drug","name":"Drug: asparaginase"},{"intervention_type":"Drug","name":"Drug: daunorubicin hydrochloride"},{"intervention_type":"Drug","name":"Drug: fludarabine phosphate"},{"intervention_type":"Drug","name":"Drug: therapeutic hydrocortisone"},{"intervention_type":"Procedure","name":"Procedure: allogeneic bone marrow transplantation"},{"intervention_type":"Radiation","name":"Radiation: 3-dimensional conformal radiation therapy"},{"intervention_type":"Biological","name":"Biological: filgrastim","description":"Given SC"},{"intervention_type":"Drug","name":"Drug: cytarabine","description":"Given IV or IT"},{"intervention_type":"Drug","name":"Drug: idarubicin","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: dexamethasone","description":"Given PO"},{"intervention_type":"Drug","name":"Drug: thioguanine","description":"Given PO"},{"intervention_type":"Drug","name":"Drug: etoposide","description":"Given IV"},{"intervention_type":"Drug","name":"Drug: methotrexate","description":"Given IT"},{"intervention_type":"Drug","name":"Drug: cyclophosphamide","description":"Given IV"},{"intervention_type":"Biological","name":"Biological: aldesleukin"},{"intervention_type":"Drug","name":"Drug: busulfan"}],"outcomes":[{"outcome_type":"primary","measure":"Frequency of toxicities, including infectious complications (induction phase)","time_frame":"Up to 42 days"},{"outcome_type":"primary","measure":"Marrow status","time_frame":"At 14 days"},{"outcome_type":"primary","measure":"Proportions of patients achieving remission rate during induction therapy","time_frame":"Up to 42 days"},{"outcome_type":"primary","measure":"Proportion of patients dying or with residual disease during induction therapy","time_frame":"Up to 42 days"},{"outcome_type":"primary","measure":"Time to marrow recovery (induction phase)","time_frame":"Up to 42 days"},{"outcome_type":"primary","measure":"Percent of blasts","time_frame":"At the end of induction therapy"},{"outcome_type":"primary","measure":"Complete remission at the end of consolidation therapy","time_frame":"Up to 5 years"},{"outcome_type":"primary","measure":"Survival following consolidation","time_frame":"Up to 5 years"},{"outcome_type":"primary","measure":"Event-free survival following consolidation","time_frame":"Up to 5 years"},{"outcome_type":"primary","measure":"Overall survival (intensification)","time_frame":"Up to 5 years"},{"outcome_type":"primary","measure":"EFS (intensification)","time_frame":"Up to 5 years"}]}
{"nct_id":"NCT00951340","start_date":"1996-07-31","phase":"Phase 1","enrollment":21,"brief_title":"Desensitization and Cognitive Therapy in General Anxiety.","official_title":"Desensitization and Cognitive Therapy in General Anxiety.","primary_completion_date":"1998-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"1998-12-31","last_update":"2017-09-20","description":"This study will test the feasibility and safety of adding interpersonal and emotional processing techniques to standard cognitive behavioral therapy for generalized anxiety disorder.","other_id":"R01MH039172-02","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Single","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Principal diagnosis of generalized anxiety disorder (GAD), as defined by the DSM-IV\r\n             and agreed on by two diagnostic interviewers\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Concurrent psychosocial therapy or past adequate dosage of CBT\r\n\r\n          -  Medical contributions to anxiety\r\n\r\n          -  Current substance abuse, psychosis, or organic brain syndrome\r\n      ","sponsor":"Penn State University","sponsor_type":"Other","conditions":"Generalized Anxiety Disorder","interventions":[{"intervention_type":"Other","name":"Other: Cognitive behavioral therapy (CBT)","description":"15 weekly therapy sessions, the first hour of which will be devoted to standard CBT techniques"},{"intervention_type":"Behavioral","name":"Behavioral: Emotional processing and interpersonal therapy","description":"15 weekly therapy sessions, the second hour of which will be devoted to interpersonal and emotional processing therapy techniques"},{"intervention_type":"Behavioral","name":"Behavioral: Listening therapy","description":"15 weekly therapy sessions, the second hour of which will be directed by the participant's questions and discussion"}],"outcomes":[{"outcome_type":"primary","measure":"Feasibility of delivering emotional processing and interpersonal therapeutic techniques","time_frame":"Measured at baseline, post-treatment, and after 6, 12, and 24 months"}]}
{"nct_id":"NCT00001547","start_date":"1996-06-30","enrollment":150,"brief_title":"Neuropsychiatric Effects of Interferon-Alpha and Ribavirin","official_title":"A Magnetic Resonance Spectroscopy Study of Neuropsychiatric Effects Associated With Cytokines","study_type":"Observational","rec_status":"Completed","completion_date":"2002-06-30","last_update":"2008-03-04","description":"Use of the drug interferon-alpha (IFN-A), is associated with frequent and well characterized side effects like neurotoxicity. Neurotoxicity can cause symptoms of depression, agitation, anxiety, and/or confusion. The NIDDK is conducting a research study called, \"Combination of Alpha Interferon with Long Term Ribavirin Therapy for Patients with Chronic Hepatitis C\" (98-DK-0003). Patients participating in it are receiving interferon-alpha in addition to an antiviral medication called ribavirin. Researchers at the NIMH intend to study patients to learn more about how different medications can influence mood, thoughts and behavior. The primary purpose of this study is to determine if treatment with IFN-A in combination with ribavirin alters human brain biochemistry as measured by proton magnetic resonance spectroscopy (MRS). MRS uses strong magnetic fields in order to measure biochemical products of metabolism found in the brain. Researchers intend to perform MRS scans before, during, and after patients receive their medications Researchers believe that the combination of IFN-A/Ribavirin will directly affect specific areas of the brain and as a result, some patients will develop specific mood or cognitive symptoms. Patients often must stop taking these medications because of the side effects. This study will not contribute directly to the treatment of patient's Hepatitis C condition. However, the information gathered from this study will help researchers better understand the neuropsychiatric affects associated with interferon alpha and ribavirin therapy.","other_id":"960103","sampling_method":"","gender":"All","population":"","criteria":"\n        Subjects must be at least 18 years of age.\r\n\r\n        Subjects eligible for this study will be those enrolled in NIDDK protocol 98-DK-0003 and\r\n        consequently at increased risk for the development of neuropsychiatric toxicity.\r\n\r\n        Subjects must be able to provide informed consent.\r\n\r\n        No individuals who are critically ill or markedly agitated or confused.\r\n\r\n        No individuals with implanted cardiac pacemakers or autodefibrillators.\r\n\r\n        No individuals with implanted neural pacemakers.\r\n\r\n        No individuals with CNS aneurysmal clips.\r\n\r\n        No individuals with cochlear implants.\r\n\r\n        No individuals with metallic foreign bodies in the eye or CNS.\r\n\r\n        No individuals with any form of implanted wire or metal device which may concentrate\r\n        radiofrequency fields.\r\n\r\n        No pregnant women.\r\n\r\n        No individuals with a history of moderate to severe claustrophobia.\r\n      ","sponsor":"National Institute of Mental Health (NIMH)","sponsor_type":"NIH","conditions":"Mental Disorder","interventions":{},"outcomes":{}}
{"nct_id":"NCT00019110","start_date":"1995-11-30","phase":"Phase 1","brief_title":"Vaccine Therapy in Treating Patients With Advanced or Recurrent Cancer","official_title":"VACCINE THERAPY AND DETECTION OF IMMUNOLOGIC RESPONSES WITH HUMAN PAPILLOMAVIRUS 16 E6 AND E7 PEPTIDES IN PATIENTS WITH METASTATIC OR LOCALLY ADVANCED CERVICAL CANCER","study_type":"Interventional","rec_status":"Completed","last_update":"2015-04-29","description":"RATIONALE: Vaccines made from certain human papillomaviruses may be able to help the body to kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of human papillomavirus vaccine therapy in treating patients who have advanced or recurrent cancer of the cervix, vagina, penis, anus, esophagus, or head and neck.","other_id":"CDR0000064330","primary_purpose":"Treatment","sampling_method":"","gender":"Female","minimum_age":18,"population":"","criteria":"\n        DISEASE CHARACTERISTICS:\r\n\r\n          -  Histologically proven stage III, IV, or recurrent carcinoma of the cervix or other\r\n             tumor that carries human papilloma virus 16 (HPV16) such as other anogenital (vulvar,\r\n             penile, and anal), esophageal, and head and neck cancers\r\n\r\n          -  HLA-A2.1 positive\r\n\r\n          -  Patients with tumors other than cervical cancer must have no other therapeutic options\r\n\r\n          -  Fresh tissue or paraffin block available for HPV genome detection and typing (optional\r\n             for cervical cancer)\r\n\r\n          -  No history of CNS metastases\r\n\r\n        PATIENT CHARACTERISTICS:\r\n\r\n        Age:\r\n\r\n          -  Over 18\r\n\r\n        Performance status:\r\n\r\n          -  ECOG 0-1\r\n\r\n        Life expectancy:\r\n\r\n          -  More than 3 months\r\n\r\n        Hematopoietic:\r\n\r\n          -  WBC at least 2,000/mm^3\r\n\r\n          -  Platelet count at least 100,000/mm^3\r\n\r\n        Hepatic:\r\n\r\n          -  Bilirubin no greater than 2.0 mg/dL\r\n\r\n          -  SGPT no greater than 4 times normal\r\n\r\n        Renal:\r\n\r\n          -  Creatinine no greater than 2.0 mg/dL\r\n\r\n        Cardiovascular:\r\n\r\n          -  No myocardial infarction within the past 6 months\r\n\r\n          -  No New York Heart Association class III or IV heart disease\r\n\r\n        Immunologic:\r\n\r\n          -  No autoimmune disease, e.g.:\r\n\r\n               -  Systemic lupus erythematosus\r\n\r\n               -  Multiple sclerosis\r\n\r\n               -  Ankylosing spondylitis\r\n\r\n               -  HIV negative\r\n\r\n          -  Responsive to 1 of the following skin test antigens:\r\n\r\n               -  Mumps Trichophyton\r\n\r\n               -  Candida Tetanus\r\n\r\n        Other:\r\n\r\n          -  No active infection requiring antibiotics\r\n\r\n          -  No weight loss greater than 20% within the past 6 months\r\n\r\n          -  No other active malignancy except basal cell skin cancer\r\n\r\n          -  Not pregnant or nursing\r\n\r\n          -  Negative pregnancy test\r\n\r\n          -  Fertile patients must use effective contraception\r\n\r\n        PRIOR CONCURRENT THERAPY:\r\n\r\n        Biologic therapy:\r\n\r\n          -  At least 4 weeks since prior immunotherapy and recovered\r\n\r\n        Chemotherapy:\r\n\r\n          -  At least 4 weeks since prior chemotherapy and recovered\r\n\r\n        Endocrine therapy:\r\n\r\n          -  At least 4 weeks since prior steroids and recovered\r\n\r\n        Radiotherapy:\r\n\r\n          -  At least 4 weeks since prior radiotherapy and recovered\r\n\r\n        Surgery:\r\n\r\n          -  Not specified\r\n\r\n        Other:\r\n\r\n          -  Recovered from the toxic effects of prior therapy\r\n      ","sponsor":"National Cancer Institute (NCI)","sponsor_type":"NIH","conditions":"Vulvar Cancer|Anal Cancer|Cervical Cancer|Esophageal Cancer|Head and Neck Cancer|Penile Cancer","interventions":[{"intervention_type":"Biological","name":"Biological: human papillomavirus 16 E7 peptide"},{"intervention_type":"Biological","name":"Biological: synthetic human papillomavirus 16 E6 peptide"}],"outcomes":{}}
{"nct_id":"NCT00003077","start_date":"1995-10-31","phase":"Phase 1/Phase 2","enrollment":63,"brief_title":"Omega-3 Fatty Acids in Treating Patients With Advanced Cancer Who Have Significant Weight Loss","official_title":"Phase I/II Trial of Omega-3 Fatty Acids for Cancer Cachexia","primary_completion_date":"2004-07-31","study_type":"Interventional","rec_status":"Completed","completion_date":"2004-11-30","last_update":"2016-07-13","description":"RATIONALE: Omega-3 fatty acids are used by the body for energy and tissue development and may be an effective treatment for patients with advanced cancer who are unable to maintain their body weight. PURPOSE: Phase I/II trial to study the effectiveness of omega-3 fatty acids in treating patients with advanced cancer who have significant weight loss.","other_id":"CALGB-9473","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Supportive Care","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":120,"population":"","criteria":"\n        DISEASE CHARACTERISTICS:\r\n\r\n          -  Histologically or cytologically proven advanced cancer not amenable to curative\r\n             therapy (solid tumors and hematologic malignancies eligible except primary and\r\n             metastatic brain tumors)\r\n\r\n          -  Cachexia (weight loss at least 2 percent within a one month period)\r\n\r\n        PATIENT CHARACTERISTICS:\r\n\r\n        Age:\r\n\r\n          -  18 and over\r\n\r\n        Performance Status:\r\n\r\n          -  CALBG 0-2\r\n\r\n        Life Expectancy:\r\n\r\n          -  At least 2 months\r\n\r\n        Hematopoietic:\r\n\r\n          -  Granulocytes greater than 1,000/mm3\r\n\r\n          -  Platelet count greater than 75,000/mm3\r\n\r\n          -  Hemoglobin greater than 8 mg/dL\r\n\r\n        Hepatic:\r\n\r\n          -  AST less than 3 times upper limit of normal (ULN)\r\n\r\n          -  Alkaline phosphatase less than 3 times ULN\r\n\r\n          -  Bilirubin less than 1.5 times ULN\r\n\r\n        Renal:\r\n\r\n          -  BUN less than 1.5 times ULN\r\n\r\n          -  Creatinine less than 1.5 times ULN\r\n\r\n        Cardiovascular:\r\n\r\n          -  No congestive heart failure requiring diuretics within less than 6 months\r\n\r\n          -  No uncontrolled or severe cardiovascular disease within less than 6 months\r\n\r\n          -  No myocardial infarction within less than 6 months\r\n\r\n        Other:\r\n\r\n          -  Not pregnant nor contemplating pregnancy during study\r\n\r\n          -  Negative pregnancy test\r\n\r\n          -  No uncontrolled hypercalcemia\r\n\r\n          -  No metabolic disorders (hyperthyroidism)\r\n\r\n          -  No poorly controlled diabetes\r\n\r\n          -  No peripheral edema or ascites requiring diuretics\r\n\r\n          -  No enteric fistulas, with tracheobronchial fistulas or with aspiration\r\n\r\n          -  No esophageal or bowel obstruction that would preclude eating\r\n\r\n          -  Free T4 within normal range\r\n\r\n          -  No serious medical illness\r\n\r\n          -  No psychosis\r\n\r\n          -  No uncontrolled bacterial, viral, or fungal infections\r\n\r\n          -  No active uncontrolled duodenal ulcers\r\n\r\n          -  Above laboratory values required unless bone marrow, liver, kidney, or splenic\r\n             involvement by tumor is documented\r\n\r\n        PRIOR CONCURRENT THERAPY:\r\n\r\n        Biologic therapy:\r\n\r\n          -  Not specified\r\n\r\n        Chemotherapy:\r\n\r\n          -  Prior and concurrent chemotherapy allowed\r\n\r\n        Endocrine therapy:\r\n\r\n          -  No concurrent steroids such as dronabinol or megestrol acetate (except for adrenal\r\n             failure)\r\n\r\n        Radiotherapy:\r\n\r\n          -  No prior or concurrent radiotherapy to abdomen or pelvis\r\n\r\n        Surgery:\r\n\r\n          -  Greater than 3 weeks since major surgery\r\n\r\n          -  Greater than 1 week since minor surgery\r\n\r\n        Other:\r\n\r\n          -  No concurrent diuretics\r\n      ","sponsor":"Alliance for Clinical Trials in Oncology","sponsor_type":"Other","conditions":"Leukemia|Lymphoma|Multiple Myeloma and Plasma Cell Neoplasm","interventions":[{"intervention_type":"Dietary Supplement","name":"Dietary Supplement: omega-3 fatty acid"}],"outcomes":[{"outcome_type":"primary","measure":"survival","time_frame":"up to 4 months"}]}
{"nct_id":"NCT00001457","start_date":"1995-09-30","phase":"Phase 2","enrollment":60,"brief_title":"Lamivudine for Chronic Hepatitis B","official_title":"Lamivudine for Chronic Hepatitis B","study_type":"Interventional","rec_status":"Completed","completion_date":"2005-09-30","last_update":"2008-03-04","description":"Chronic hepatitis B is a disease of the liver caused by the hepatitis B virus. It affects nearly 1 million Americans. Approximately 25% of patients with chronic hepatitis B will develop liver cirrhosis and 5% of patients will develop liver cancer. Presently, two medications have been shown effective in the treatment of hepatitis B: lamivudine and alpha interferon. Alpha interferon (an antiviral drug that acts through the immune system) is given by injection once daily or three times a week for four to six months. Lamivudine (also known as 3-thiacytidine: 3TC) is an antiviral medication given as a pill once a day for twelve months. These treatments have been known to provide long-term improvement in one third of patients receiving them. In previous research, the drug lamivudine was shown to stop the growth of the hepatitis B virus and to lead marked decreases in the levels of hepatitis B virus and to improvements in the disease in 50 to 70% of patients. However, once lamivudine therapy was discontinued the virus returned to levels noted before the therapy began. In those studies lamivudine was given for 3 to 12 months then discontinued. This study will investigate the safety and effectiveness of long-term therapy with lamivudine. This study will select 60 patients diagnosed with hepatitis B. After a thorough medical examination and liver biopsy, subjects will be given lamivudine. The drug will be taken by mouth in tablet form (100 mg) once a day for up to 5 years. Subjects will undergo regular check-ups and after 1 year of therapy be admitted to the Clinical Center for another medical examination and liver biopsy to assess progress. Patients who have benefitted from the therapy will continue taking the medication for up to 5 years. A third liver biopsy will be done during the last year of treatment. The effectiveness of lamivudine will be determined by whether levels of hepatitis B virus decrease in the blood, whether liver enzymes improve, and whether inflammation and scarring decreases in the liver biopsies.","other_id":"950199","primary_purpose":"Treatment","sampling_method":"","gender":"All","population":"","criteria":"\n        INCLUSION CRITERIA\r\n\r\n        Age 18 years or above, male or female.\r\n\r\n        Known presence of HBsAg in serum for at least 6 months.\r\n\r\n        Liver biopsy histology showing chronic hepatitis with or without cirrhosis.\r\n\r\n        Previous therapy with alpha interferon without a lasting effect or intolerance to alpha\r\n        interferon, due to side effects.\r\n\r\n        Written informed consent.\r\n\r\n        Group A: For patients with chronic hepatitis B with atypical serology: absence of HBeAg\r\n        from serum despite elevations in serum aminotransferases, such as that the average levels\r\n        are greater than 55 U/L (approximately 1.3 times the upper limit of the normal range) based\r\n        upon two determinations taken at least one month apart during the 6 months before entry.\r\n\r\n        Group B: For patients with glomerulonephritis: proteinuria of greater than 1 gm per 24\r\n        hours. For patients with polyarteritis, radiological proof of arteritis and involvement of\r\n        at least on organ system outside of the liver.\r\n\r\n        Group C: For patients with chronic delta hepatitis: anti-HDV in serum and HDV antigen in\r\n        liver biopsy or HDV RNA in serum and elevations in serum aminotransferases, such that the\r\n        average levels are greater than 55 U/L based upon two determinations taken at least one\r\n        month apart during the 6 months before entry.\r\n\r\n        Group D: For patients with chronic hepatitis B and typical serology: HBeAg and HBV DNA in\r\n        serum but ineligibility to enter the multicenter trial of lamivudine either because of\r\n        previous receipt of interferon and intolerable side effects, refusal to receive interferon\r\n        again, because of normal serum aminotransferases, or lack of availability of the trial.\r\n\r\n        EXCLUSION CRITERIA\r\n\r\n        Pregnant or if capable of bearing or fathering children must practice adequate\r\n        contraception.\r\n\r\n        Significant systemic illnesses other than liver diseases, including congestive heart\r\n        failure, renal failure, chronic pancreatitis, diabetes mellitus with poor control.\r\n\r\n        Pre-existing bone marrow compromise: hematocrit must be greater than 30%, white blood cell\r\n        count must be greater than 2000 mm(3), platelets must be greater than 70,000 mm(3).\r\n\r\n        Creatinine clearance must be greater than 50 cc/min.\r\n\r\n        A history of clinically apparent pancreatitis or evidence of subclinically pancreatitis as\r\n        shown by serum amylase values twice the upper limits of the normal range and abnormalities\r\n        of the pancreas on computerized tomography or other imaging studies of the abdomen.\r\n\r\n        Irreversibly severe cirrhosis as defined by Child's stage C.\r\n\r\n        Presence of anti-HIV or anti-HCV with HCV RNA in serum.\r\n\r\n        Immunosuppressive therapy requiring use of more than 10 mg of prednisone (or its\r\n        equivalent) per day.\r\n\r\n        Other antiviral therapy for chronic hepatitis B within the previous 3 months.\r\n\r\n        Sensory or motor neuropathy apparent from medical history and physical examination.\r\n      ","sponsor":"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","sponsor_type":"NIH","conditions":"Chronic Hepatitis B|Chronic Hepatitis D|Glomerulonephritis|Polyarteritis Nodosa","interventions":[{"intervention_type":"Drug","name":"Drug: Lamivudine"}],"outcomes":{}}
{"nct_id":"NCT00005529","start_date":"1995-09-30","brief_title":"Self-Scored Cardiovascular Disease Risk Appraisal","study_type":"Observational","rec_status":"Completed","completion_date":"2000-08-31","last_update":"2016-02-18","description":"To develop and test a self-scored cardiovascular disease health risk appraisal.","other_id":"5062","sampling_method":"","gender":"Male","maximum_age":100,"population":"","criteria":"\n        No eligibility criteria\r\n      ","sponsor":"National Heart, Lung, and Blood Institute (NHLBI)","sponsor_type":"NIH","conditions":"Cardiovascular Diseases|Heart Diseases|Coronary Heart Disease Risk Reduction","interventions":{},"outcomes":{}}
{"nct_id":"NCT00004773","start_date":"1995-08-31","enrollment":95,"brief_title":"Study of Cardiac and Paroxysmal Abnormalities in Rett Syndrome","study_type":"Observational","rec_status":"Completed","completion_date":"1997-06-30","last_update":"2005-06-24","description":"OBJECTIVES: I. Evaluate electrocardiographic parameters, including QT and PR intervals and QRS morphology/duration, across clinical stages in patients with Rett syndrome. II. Characterize abnormalities of cardiac conduction and repolarization. III. Assess arrhythmias, heart rate variability, and autonomic nervous system function in these patients using 24-hour Holter monitoring. IV. Record events believed to represent seizures with video, electroencephalogram (EEG), and polygraph monitoring in patients who have more than 1 clinical seizure every 5 days. V. Characterize these events with respect to clinical manifestations, EEG correlates, and other physiologic data. VI. Determine the frequency of seizures vs. events without electrographic correlates in these patients. VII. Determine whether Rett syndrome patients have characteristic or unique types of seizures and/or an epileptic syndrome.","other_id":"199/11798","sampling_method":"","gender":"Female","population":"","criteria":"\n        -  Classical Rett syndrome meeting Rett Syndrome Diagnostic Work Group criteria\r\n\r\n          -  Age-matched girls without neurologic or cardiac problems entered as controls\r\n      ","sponsor":"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","sponsor_type":"NIH","conditions":"Rett Syndrome","interventions":{},"outcomes":{}}
{"nct_id":"NCT00341276","start_date":"1995-07-06","enrollment":7705,"brief_title":"Esophageal Cancer Genetics Studies","official_title":"Esophageal Cancer Genetics Studies","study_type":"Observational","rec_status":"Completed","last_update":"2021-09-02","description":"The overall goal of this project is to understand the role of genetics in the etiology and prevention of upper gastrointestinal cancer, primarily esophageal cancer, but also cancers of the gastric cardia and body. Esophageal cancer is the second most common cause of cancer death in China and the seventh most common cause of cancer death worldwide. Evidence suggests that genetic factors may play an important role in the etiology of this malignancy, and identification of esophageal cancer susceptibility genes may allow screening of populations to identify persons at particularly high risk, who could then be targeted for prevention strategies (e.g., chemoprevention or early detection). There are several lines of evidence supporting the idea that there is genetic susceptibility for esophageal cancer in high-risk Chinese populations, including an association of positive family history with increased risk, evidence of familial aggregation of cases, and segregation analyses suggesting Mendelian inheritance in high-risk families. Several different but complementary approaches will be used to identify esophageal cancer susceptibility genes. (Because of etiologic similarities and for logistic reasons, parallel efforts will be made with gastric cardia and body cancers.) First, a tumor/non-tumor study will be conducted in which a biological specimen bank consisting of samples (tumor, non-tumor, venous blood, finger stick blood, and buccal cells) from several hundred cases of esophageal, gastric cardia, and gastric body cancers will be developed in Taiyuan that can be used for the identification of esophageal (as well as gastric cardia and body) cancer susceptibility genes and potential early genetic markers of these cancers. High-density genome-wide scans with microsatellite markers will be used in a limited number of cases to identify potential hot spots followed by further testing of these hot spots and other candidate markers in additional tumor/non-tumor samples. Premalignant morphologic lesions will also be examined. Second, blood samples for DNA will be collected from approximately 100 healthy individuals from high-risk (Yangcheng County) and low-risk (Beijing) areas to examine potential population differences in polymorphisms for selected genomic markers. Third, a large case-control study with cancers of the esophagus, cardia, and body of stomach will be conducted to evaluate polymorphisms in the candidate markers identified in other components of this project, and to evaluate gene-environment interactions. Finally, a family study will be conducted to evaluate linkage of candidate markers with cancer in families having 2 or more cases with cancers of the esophagus, cardia, and/or body of stomach.","other_id":"999995027","observational_model":"Other","time_perspective":"Other","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"maximum_age":100,"population":"First, several hundred cases of esophageal cancer and gastric cancer (both cardia and body)\r\n        ascertained in Taiyuan at the Shanxi Cancer Hospital. Second, several hundred healthy\r\n        individuals from high-risk (Yangcheng County) and low-risk (Beijing) areas. Third, a large\r\n        case-control study with cases of esophageal cancer and gastric cancer (both cardia and\r\n        body) and neighborhood controls selected from Shanxi Province was conducted. Follow-up of\r\n        cases from the case-control study has been conducted to determine vital status. Fourth, a\r\n        family study is in progress with selection of families having 2 or more cases with\r\n        esophageal cancer or gastric cancer; follow-up of family members and accrual of new\r\n        families is ongoing in Yangcheng county, Shanxi Province. Finally, an endoscopic study has\r\n        been conducted at Shanxi Cancer Hospital to obtain specimens from a morphologic spectrum of\r\n        disease ranging from normal to early invasive esophageal cancer.","criteria":"\n        -  INCLUSION CRITERIA:\r\n\r\n        All patients over the age of 18 presenting to the SCHI with upper GI signs or symptoms\r\n        requiring upper GI endoscopy over a defined calendar period (depending on prevalence of\r\n        premalignant lesions, but estimated to be approximately 3 years) will be potentially\r\n        eligible for participation in this study.\r\n\r\n        Patients are eligible only if they meet one of the following two conditions: (1) a visible\r\n        lesion unlikely to be cancer or (2) no visible lesions on routine endoscopy (without\r\n        mucosal iodine staining) but an unstained (abnormal) lesion following iodine spraying.\r\n\r\n        Invitation for participation will be based solely on the visual appearance of an esophageal\r\n        abnormality without or with mucosal iodine staining, but before histologic confirmation is\r\n        obtained, and will occur during the same clinic visit as the qualifying endoscopic\r\n        examination.\r\n\r\n        EXCLUSION CRITERIA:\r\n\r\n        Patients will not be invited to participate in this study until after they have undergone\r\n        their routine endoscopic evaluation.\r\n      ","sponsor":"National Cancer Institute (NCI)","sponsor_type":"NIH","conditions":"Esophageal Cancer|Gastric (Cardia, Body) Cancer","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Esophageal cancer susceptibility (tumor /nontumor)","time_frame":"ongoing","description":"Obtain tumor and nontumor DNA samples from patients with esophageal cancer and examine markers in these tissues for differences that might suggest genomic loci associated with thedevelopment of (and, potentially, susceptibility to) esophageal cancer"},{"outcome_type":"primary","measure":"Gene frequency and associated risk (high risk / low risk)","time_frame":"ongoing","description":"Obtain DNA from healthy individuals from populations at high-risk and low-risk for esophageal cancer and examine their DNA for differences in gene frequency at selected loci"},{"outcome_type":"primary","measure":"Case-control","time_frame":"ongoing","description":"Obtain nontumor DNA from esophageal cancer cases and controls without cancer and examine candidate markers for differences that might be associated with esophageal cancer susceptibility"},{"outcome_type":"primary","measure":"Linkage of genetic markers","time_frame":"ongoing","description":"Obtain nontumor DNA from esophageal cancer cases and their family members and evaluate candidate markers for genetic linkage"},{"outcome_type":"secondary","measure":"Gene environment interactions (case control)","time_frame":"ongoing","description":"Evaluate potential geneenvironment interactions in the etiology and prevention of esophageal cancer in the case-control study"}]}
{"nct_id":"NCT04477720","start_date":"1995-06-30","enrollment":1000,"brief_title":"Retrospective Analysis of De-identified Deceased HCC Patients","official_title":"HCC Observation Study","primary_completion_date":"2009-05-31","study_type":"Observational","rec_status":"Completed","completion_date":"2009-05-31","last_update":"2020-07-20","description":"De-identified deceased HCC patients who were not surgical candidates were evaluated for their clinical baseline characteristics associated with their survival. Baselines included tumor markers, blood counts and liver function tests and CAT-scan based tumor size and numbers and presence of portal vein thrombosis.","other_id":"BCarr","observational_model":"Cohort","time_perspective":"Retrospective","sampling_method":"Non-Probability Sample","gender":"All","minimum_age":18,"population":"Patients presenting for HCC management","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  biopsy-proven HCC\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  none\r\n      ","sponsor":"Carr, Brian","sponsor_type":"Other","conditions":"Survival","interventions":{},"outcomes":[{"outcome_type":"primary","measure":"Survival","time_frame":"10 years"}]}
{"nct_id":"NCT00004334","start_date":"1994-07-31","enrollment":8,"brief_title":"Study of Depression, Peptides, and Steroids in Cushing's Syndrome","study_type":"Observational","rec_status":"Unknown status","last_update":"2005-06-24","description":"OBJECTIVES: I. Study the relationship between dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis and disorders of mood, vegetative function, and cognition in patients with Cushing's disease. II. Identify subgroups of patients with Cushing's disease who differ in the presence and severity of the depressive syndrome, and uncover HPA axis dysregulation differences among them using corticotropin-releasing hormone, metyrapone, and dexamethasone challenge testing.","other_id":"NCRR-M01RR00042-1781","sampling_method":"","gender":"All","minimum_age":20,"maximum_age":60,"population":"","criteria":"\n        PROTOCOL ENTRY CRITERIA:\r\n\r\n          -  Patients aged 20 to 60 with spontaneous active Cushing's syndrome\r\n\r\n          -  At least 2 weeks since medication with psychoactive effects or influence on cortisol\r\n             metabolism by hepatic hydroxylating enzyme induction\r\n\r\n          -  Antihypertensives allowed for severe hypertension\r\n\r\n          -  No barbiturates\r\n\r\n          -  No phenytoin\r\n      ","sponsor":"National Center for Research Resources (NCRR)","sponsor_type":"NIH","conditions":"Cushing's Syndrome","interventions":{},"outcomes":{}}
{"nct_id":"NCT00002568","start_date":"1994-06-30","phase":"Phase 3","enrollment":470,"brief_title":"Combination Chemotherapy With or Without Surgery in Treating Patients With Stage III Ovarian Epithelial Cancer","official_title":"A PHASE III RANDOMIZED STUDY OF CISPLATIN (NSC #119875) AND TAXOL (PACLITAXEL) (NSC #125973) WITH INTERVAL SECONDARY CYTOREDUCTION VERSUS CISPLATIN AND PACLITAXEL IN PATIENTS WITH SUBOPTIMAL STAGE III & IV EPITHELIAL OVARIAN CARCINOMA","primary_completion_date":"2004-12-31","study_type":"Interventional","rec_status":"Completed","last_update":"2013-07-09","description":"RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug or combining chemotherapy with surgery may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy consisting of paclitaxel and cisplatin with or without surgery in treating patients with stage III ovarian epithelial cancer.","other_id":"CDR0000063600","allocation":"Randomized","primary_purpose":"Treatment","sampling_method":"","gender":"Female","population":"","criteria":"\n        DISEASE CHARACTERISTICS: Histologically confirmed primary ovarian epithelial cancer Stage\r\n        III disease, i.e.: Greater than 1 cm residual intraperitoneal disease following exploratory\r\n        laparotomy with maximum debulking Laparoscopic resection alone insufficient The following\r\n        histologies are eligible: Serous adenocarcinoma Transitional cell carcinoma Mucinous\r\n        adenocarcinoma Undifferentiated carcinoma Clear cell adenocarcinoma Mixed epithelial\r\n        carcinoma Adenocarcinoma Endometrioid tumor Adenocarcinoma NOS Malignant Brenner's tumor No\r\n        unclassified ovarian cancer (i.e., unexplored tumors thought to be of ovarian origin or\r\n        tumors not verified as arising from ovarian stroma) No borderline (grade 0) or \"probably\r\n        malignant\" carcinoma Measurable disease preferred Patients eligible for this protocol are\r\n        also eligible for protocol GOG-136\r\n\r\n        PATIENT CHARACTERISTICS: Age: Any age Performance status: GOG 0-2 Hematopoietic: WBC at\r\n        least 3,000/mm3 Absolute granulocyte count at least 1,500/mm3 Platelet count at least\r\n        100,000/mm3 Hepatic: Bilirubin no more than 1.5 times normal ALT, AST, and GGT no more than\r\n        3 times normal Alkaline phosphatase no more than 3 times normal LDH no more than 3 times\r\n        normal Renal: Creatinine no more than 2.0 mg/dL Cardiovascular: No history of congestive\r\n        heart failure No myocardial infarction within 6 months No unstable angina Other: No\r\n        septicemia or severe infection No acute hepatitis No severe gastrointestinal bleeding No\r\n        second malignancy within 5 years except nonmelanomatous skin cancer Not pregnant or nursing\r\n        Effective contraception required of fertile patients\r\n\r\n        PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior cytotoxic\r\n        chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery:\r\n        See Disease Characteristics No more than 6 weeks since staging surgery\r\n      ","sponsor":"Gynecologic Oncology Group","sponsor_type":"Other","conditions":"Ovarian Cancer","interventions":[{"intervention_type":"Drug","name":"Drug: cisplatin"},{"intervention_type":"Drug","name":"Drug: paclitaxel"},{"intervention_type":"Procedure","name":"Procedure: conventional surgery"}],"outcomes":{}}
{"nct_id":"NCT00701792","start_date":"1994-03-31","phase":"N/A","enrollment":120,"brief_title":"Liver Transplantation Versus Alternative Therapies for Patients With Pugh B Alcoholic Cirrhosis","official_title":"Randomized Trial Comparing Liver Transplantation to Alternative Therapies for Patients With Pugh B Alcoholic Cirrhosis","primary_completion_date":"2006-11-30","study_type":"Interventional","rec_status":"Completed","completion_date":"2006-11-30","last_update":"2008-06-19","description":"Liver transplantation has been universally recognized to improve survival of patients suffering from end-stage (Pugh C) alcoholic cirrhosis. However, for Pugh B patients, the benefit of liver transplantation remains to be demonstrated. The aim of the present study was to compare the outcome of Pugh B patients with alcoholic cirrhosis randomly assigned for immediate liver transplantation (group 1) or standard treatments (group 2).","other_id":"N/1993/04","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":65,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  cirrhosis\r\n\r\n          -  age 18-65yrs\r\n\r\n          -  Pugh B\r\n\r\n          -  written consent\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  HIV, HBV or HCV infection\r\n\r\n          -  hepatocellular carcinoma\r\n\r\n          -  Pugh A or Pugh C cirrhosis\r\n\r\n          -  creatinin >200Mol/L\r\n\r\n          -  sepsis\r\n\r\n          -  psychiatric disorders\r\n\r\n          -  extrahepatic neoplasia\r\n      ","sponsor":"Centre Hospitalier Universitaire de Besancon","sponsor_type":"Other","conditions":"Cirrhosis","interventions":[{"intervention_type":"Procedure","name":"Procedure: liver transplantation","description":"liver transplantation"},{"intervention_type":"Other","name":"Other: standard care for liver disease","description":"standard care for liver disease included therapy for ascitis (spironolactone, furosemide), portal hypertension (oesophageal varices ; propranolol), encephalopathy (lactulose), and bacterial infections whatever their localization (prophylaxis of spontaneous peritonitis with norfloxacin). All medical or instrumental procedures were allowed. Patients undergoing iterative paracentesis, variceal band ligation or sclerotherapy, peritoneojugular shunt (LeVeen), transjugular intrahepatic portosystemic shunt (TIPS) or surgical portocaval anastomosis were considered as receiving \"standard medical therapy\"."}],"outcomes":[{"outcome_type":"primary","measure":"all causes mortality","time_frame":"five years"}]}
{"nct_id":"NCT00004744","start_date":"1993-02-28","phase":"Phase 3","enrollment":76,"brief_title":"Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Multiple Sclerosis","primary_completion_date":"1998-09-30","study_type":"Interventional","rec_status":"Completed","last_update":"2008-09-09","description":"OBJECTIVES: I. Determine whether high-dose intravenous immune globulin (IVIG) is more effective than placebo in restoring neurologic function (muscle strength) in patients with multiple sclerosis. II. Determine the time to recovery following IVIG.","other_id":"199/11660","allocation":"Randomized","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        PROTOCOL ENTRY CRITERIA:\r\n\r\n        --Disease Characteristics--\r\n\r\n          -  Clinically or laboratory-supported definite multiple sclerosis\r\n\r\n          -  Disease relapsing-remitting or relapsing-progressive (i.e., secondary- progressive)\r\n\r\n          -  Targeted neurologic deficit as follows: 25% or more loss of power in at least 1 limb\r\n             Severity -1 or greater on Mayo Clinic rating scale OR Between 3+/5 and 4-/5 on Medical\r\n             Research Clinic muscle power scale\r\n\r\n          -  Documented by Mayo Clinic Department of Neurology as neither progressing nor improving\r\n             for 4 to 18 months prior to entry No clinical evidence of spontaneous or\r\n             corticosteroid-induced improvement\r\n\r\n          -  Able to cooperate with isometric strength testing requirements\r\n\r\n        --Prior/Concurrent Therapy--\r\n\r\n          -  No concurrent experimental drug therapy\r\n\r\n          -  No concurrent intravenous immune globulin At least 3 months since immunosuppressive\r\n             therapy, e.g., corticosteroids and corticotropin\r\n\r\n          -  At least 3 months since plasma exchange\r\n\r\n        --Patient Characteristics--\r\n\r\n          -  Hepatic: No coagulation defect, e.g., hyperviscosity syndrome\r\n\r\n          -  Renal: Creatinine no greater than 1.5 times normal\r\n\r\n          -  Cardiovascular: No unstable or advanced ischemic or cerebrovascular disease, e.g.:\r\n             angina congestive heart failure transient ischemic attack stroke\r\n\r\n          -  Immunologic: No human gamma globulin or albumin sensitivity No hypergammaglobulinemia\r\n             No known antibody deficiency syndrome, especially IgA deficiency\r\n\r\n        Other:\r\n\r\n          -  No condition interfering with neurologic exam, e.g.:\r\n\r\n          -  Major amputation\r\n\r\n          -  Deforming arthritis\r\n\r\n          -  Major psychiatric illness\r\n\r\n          -  Superimposed lower motor neuron deficit\r\n\r\n          -  No intellectual impairment precluding study participation\r\n\r\n          -  No pregnant or nursing women\r\n\r\n          -  Adequate contraception required of fertile patients\r\n      ","sponsor":"National Institute of Neurological Disorders and Stroke (NINDS)","sponsor_type":"NIH","conditions":"Multiple Sclerosis","interventions":[{"intervention_type":"Drug","name":"Drug: immune globulin"}],"outcomes":{}}
{"nct_id":"NCT00913783","start_date":"1992-11-30","phase":"Phase 1","enrollment":36,"brief_title":"To Demonstrate the Relative Bioavailability of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fasted Conditions","official_title":"Comparative, Randomized, 2-way Crossover Bioavailability Study of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules In Health Adult Males Under Fasted Conditions","primary_completion_date":"1992-12-31","study_type":"Interventional","rec_status":"Completed","completion_date":"1992-12-31","last_update":"2017-03-28","description":"To demonstrate the relative bioavailability of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride capsules under fasted conditions.","other_id":"920256","allocation":"Randomized","intervention_model":"Crossover Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"Male","minimum_age":18,"maximum_age":45,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  No clinically significant abnormal finding on physical exam, medical history, or\r\n             clinical laboratory results on screening.\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Positive test results for HIV or hepatitis B or C.\r\n\r\n          -  Treatment for drug or alcohol dependence.\r\n      ","sponsor":"Sandoz","sponsor_type":"Industry","conditions":"Depression","interventions":[{"intervention_type":"Drug","name":"Drug: Clomipramine Hydrochloride 25 mg Capsules (Geneva Pharmaceuticals)"},{"intervention_type":"Drug","name":"Drug: Anafranil Clomipramine Hydrochloride 25 mg Capsules (Basel)"}],"outcomes":[{"outcome_type":"primary","measure":"Bioequivalence based on AUC and Cmax","time_frame":"34 days"}]}
{"nct_id":"NCT00001317","start_date":"1992-05-31","phase":"Phase 4","enrollment":100,"brief_title":"A Phase IV Study of Recombinant Human Gamma Interferon in Patients With Chronic Granulomatous Diseases of Childhood","official_title":"A Phase IV Study of Recombinant Human Gamma Interferon in Patients With Chronic Granulomatous Diseases of Childhood","study_type":"Interventional","rec_status":"Completed","completion_date":"2001-07-31","last_update":"2008-03-04","description":"In a recent double-blinded, placebo-controlled multi-center international study, subcutaneous injections of interferon-gamma administered three times weekly reduced the frequency of serious infections in patients with chronic granulomatous disease. Patients receiving interferon-gamma had fewer hospital stays, shorter in length, than the placebo group. Children less than 10 years of age benefitted most from treatment and had fewer side effects. Based on these data, the FDA licensed interferon-gamma for prophylaxis in CGD patients. We wish to monitor our patients who participated in the original study for possible long-term side effects. Any new patients referred to us who are either on interferon-gamma or considered to be candidates for interferon-gamma will be considered for this protocol. In addition, our patients who were originally accepted under Genentech's compassionate plea protocol will also be monitored under this new protocol. The patients will be evaluated every six months, with blood work and interim medical histories taken.","other_id":"920186","primary_purpose":"Treatment","sampling_method":"","gender":"All","population":"","criteria":"\n        The diagnosis of chronic granulomatous disease as indicated by an unusual pattern of\r\n        infection in the patient or one pedigree relation, confirmed by both of the following\r\n        tests:\r\n\r\n        Abnormal neutrophil NBT slide test (following PMA stimulation) and neutrophil superoxide\r\n        anion production less than or equal to 20 percent normal.\r\n\r\n        Preserved renal function (creatinine less than or equal to 2.0 mg/100 mL; less than or\r\n        equal to 2+ proteinuria).\r\n\r\n        Preserved hepatic function (bilirubin less than or equal to 1.5 mg/100 mL; prothrombin time\r\n        less than or equal to 1.3 x control).\r\n\r\n        Preserved hematologic function (WBC greater than or equal to 3000/mm3; granulocytes greater\r\n        than 1500/mm3; platelets greater than or equal to 100,000/mm3).\r\n\r\n        A minimum life expectancy of three months.\r\n\r\n        Patients seropositive for Hepatitis B surface antigen may be entered but serum specimens\r\n        for rIFN-y antibody should not be collected.\r\n\r\n        Patients must not be pregnant or lactating.\r\n\r\n        Patients of childbearing potential may be entered if using effective contraception.\r\n\r\n        Full recovery from previous serious infections requiring hospitalization and parenteral\r\n        antibiotic therapy. At least two weeks must elapse following the cessation of parenteral\r\n        antibiotic therapy before study admission.\r\n      ","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","sponsor_type":"NIH","conditions":"Chronic Granulomatous Disease","interventions":[{"intervention_type":"Drug","name":"Drug: interferon-gamma"}],"outcomes":{}}
{"nct_id":"NCT00005410","start_date":"1991-06-30","brief_title":"Epidemiology of Coronary Heart Disease in Blacks","study_type":"Observational","rec_status":"Completed","completion_date":"1993-05-31","last_update":"2016-02-18","description":"To conduct an analysis of the epidemiology of coronary heart disease (CHD) in Blacks using data collected from the 'Survival and Ventricular Enlargement (SAVE) Following Myocardial Infarction' study.","other_id":"4328","sampling_method":"","gender":"Male","maximum_age":100,"population":"","criteria":"\n        No eligibility criteria\r\n      ","sponsor":"National Heart, Lung, and Blood Institute (NHLBI)","sponsor_type":"NIH","conditions":"Cardiovascular Diseases|Heart Diseases|Coronary Disease|Myocardial Infarction","interventions":{},"outcomes":{}}
{"nct_id":"NCT00005718","start_date":"1990-04-30","brief_title":"Evaluation of Cholesterol Education for At-Risk Children","study_type":"Observational","rec_status":"Completed","completion_date":"1993-03-31","last_update":"2016-02-18","description":"To evaluate two educational programs that promoted the role of pediatric practices in lowering LDL cholesterol levels in 4-10 year old hypercholesterolemic children through dietary modification.","other_id":"4927","sampling_method":"","gender":"All","minimum_age":4,"maximum_age":10,"population":"","criteria":"\n        No eligibility criteria\r\n      ","sponsor":"National Heart, Lung, and Blood Institute (NHLBI)","sponsor_type":"NIH","conditions":"Cardiovascular Diseases|Heart Diseases|Hypercholesterolemia|Coronary Heart Disease Risk Reduction","interventions":{},"outcomes":{}}
{"nct_id":"NCT00000392","start_date":"1990-01-31","phase":"Phase 2","enrollment":215,"brief_title":"Phase II Study of the Efficacy of Peptide T in HIV-Positive Individuals With Cognitive Impairment.","official_title":"Phase II Study of the Efficacy of Peptide T in HIV-Positive Individuals With Cognitive Impairment.","primary_completion_date":"1996-08-31","study_type":"Interventional","rec_status":"Completed","completion_date":"1996-08-31","last_update":"2017-02-28","description":"To evaluate the chemical efficacy and safety of intranasally administered peptide T on neurocognitive function in HIV seropositive individuals. Previous studies have shown that treatment with peptide T can result in cognitive improvement in HIV-infected patients. Patients are randomized to receive either peptide T or placebo for the first 6 months. All patients then receive open-label peptide T for approximately 6 additional months. Neuropsychologic tests are used to determine drug effects.","other_id":"N01 MH00013","allocation":"Randomized","intervention_model":"Parallel Assignment","primary_purpose":"Treatment","masking_description":"Double","sampling_method":"","gender":"All","minimum_age":18,"maximum_age":60,"population":"","criteria":"\n        Inclusion Criteria:\r\n\r\n          -  Patients must have:\r\n\r\n               1. Cognitive dysfunction on neuropsychological testing.\r\n\r\n               2. HIV antibody positivity.\r\n\r\n               3. Expected survival of 6 months.\r\n\r\n               4. EITHER no use of an antiretroviral within the past 4 weeks OR use of approved\r\n                  regimens of AZT, ddI, or ddC.\r\n\r\n               5. Medically stable EKG and urinalysis.\r\n\r\n               6. Given informed, written consent to participate.\r\n\r\n          -  Allowed:\r\n\r\n               1. Inhaled aerosolized pentamidine for Pneumocystis carinii pneumonia prophylaxis,\r\n                  dapsone, cotrimoxazole, topical antifungal agents, nystatin or ketoconazole,\r\n                  acyclovir.\r\n\r\n               2. Amitriptyline (up to 50 mg/day) or an equivalent dose of another antidepressant\r\n                  for relief of peripheral neuropathy that is expected to remain unchanged\r\n                  throughout the first 6 months of the study.\r\n\r\n          -  Abstinence or agree to use barrier methods of birth control / contraception during the\r\n             study\r\n\r\n          -  Negative pregnancy test within 30 days of study entry\r\n\r\n          -  Bilirubin <= 3\r\n\r\n          -  CD4 (Must be <= 500 cells/mm3 if patient is without non-cognitive HIV-related\r\n             symptoms. CD4 count > 500 cells/mm3 allowed if patient has other (non-cognitive)\r\n             HIV-related symptoms. ( 0 - 100 - 200 - 300 - 400 - 500 - 600 - 700 - 800 plus.)\r\n\r\n          -  Creatinine <= 1.5 mg/dl\r\n\r\n          -  Granulocytes >= 750\r\n\r\n          -  Hemoglobin > 8 g/dl (No more than two transfusions per month permitted.)\r\n\r\n          -  Other Lab Values Prothrombin time > 70 percent of control.\r\n\r\n          -  Platelet Count >= 75000 /mm3\r\n\r\n          -  SGOT(AST) < 5 x ULN (ULN = upper limit of normal).\r\n\r\n        Exclusion Criteria:\r\n\r\n          -  Patients with the following are excluded:\r\n\r\n               1. History of mental retardation or learning disability.\r\n\r\n               2. Evidence of current DSM-III-R Axis I disorder within 3 months prior to study\r\n                  entry or past history of psychotic disorder or bipolar mania.\r\n\r\n               3. History of neurologic disorder not secondary to HIV infection (e.g., head trauma\r\n                  requiring medical observation or hospitalization, seizure disorder).\r\n\r\n          -  Patients with the following symptoms or conditions are excluded:\r\n\r\n               1. Kaposi's sarcoma or other malignancy likely to require chemotherapy during the\r\n                  first 6 months of the study.\r\n\r\n               2. Serious underlying medical problems that may complicate interpretation of the\r\n                  treatment results, including unstable diabetes mellitus, severe arteriosclerotic\r\n                  heart disease, uncontrolled hypertension, or hepatic or renal failure.\r\n\r\n               3. Non-HIV related condition that is likely to interfere with interpretation of\r\n                  neuropsychologic test results.\r\n\r\n               4. Inability to participate in neuropsychologic testing or unable to comply with\r\n                  intranasal study medication administration.\r\n\r\n          -  Excluded within 4 weeks prior to study entry:\r\n\r\n               1. Antiretrovirals except as allowed in the Patient Inclusion Criteria.\r\n\r\n               2. Psychoactive agents (e.g., benzodiazepines, antidepressants, antipsychotics,\r\n                  amphetamines)\r\n\r\n        Excluded within 8 weeks prior to study entry:\r\n\r\n        Long-acting psychoactive agents (e.g., Prozac).\r\n\r\n          -  Active alcohol abuse in the past 3 months, or abuse judged by the investigators as\r\n             likely to interfere with the analyses of neuropsychologic function. Abuse of cocaine,\r\n             marijuana, heroin or other opiates (including methadone), barbiturates, amphetamines\r\n             or other substances within the past 3 months, judged by the investigators as likely to\r\n             interfere with the analyses of neuropsychologic tests.\r\n\r\n          -  Positive pregnancy test within 30 days of study entry\r\n\r\n          -  No abstinence or no agreement to use barrier methods of birth control / contraception\r\n             during the study\r\n      ","sponsor":"National Institute of Mental Health (NIMH)","sponsor_type":"NIH","conditions":"HIV Infections|Cognition Disorders","interventions":[{"intervention_type":"Drug","name":"Drug: Peptide T"},{"intervention_type":"Drug","name":"Drug: Placebo"}],"outcomes":[{"outcome_type":"primary","measure":"Change in Global Neurocognitive Performance z Score From Baseline","time_frame":"Baseline and 6 months","description":"Higher values for change in z-score represent an improvement in Neurocognitive Performance (NP)"},{"outcome_type":"secondary","measure":"Change in Neurocognitive Performance Domain z Scores From Baseline","time_frame":"Baseline and 6 months","description":"Higher values for change in z-score represent an improvement in Neurocognitive Performance (NP)"}]}
{"nct_id":"NCT00005209","start_date":"1987-08-31","brief_title":"Genetic Epidemiology of Coronary Heart Disease","primary_completion_date":"2007-07-31","study_type":"Observational","rec_status":"Completed","completion_date":"2007-07-31","last_update":"2016-07-29","description":"To relate observations at the DNA level to the distribution of coronary heart disease in the population at large.","other_id":"1088","sampling_method":"","gender":"Male","maximum_age":100,"population":"","criteria":"\n        No eligibility criteria\r\n      ","sponsor":"National Heart, Lung, and Blood Institute (NHLBI)","sponsor_type":"NIH","conditions":"Cardiovascular Diseases|Heart Diseases|Coronary Disease","interventions":{},"outcomes":{}}
{"nct_id":"NCT01324063","start_date":"1986-11-30","phase":"Phase 3","enrollment":160,"brief_title":"A Randomized Phase III Study of Intensive Consolidation With High Dose Cytosine Arabinoside in Acute Myelogenous Leukemia (AML-8B)","official_title":"A Randomized Phase III Study of Intensive Consolidation With High Dose Cytosine Arabinoside in Acute Myelogenous Leukemia (AML-8B)","primary_completion_date":"1994-06-30","study_type":"Interventional","rec_status":"Completed","last_update":"2012-07-16","description":"RATIONALE: Patient abstract not available PURPOSE: Patient abstract not available","other_id":"EORTC-06864","allocation":"Randomized","primary_purpose":"Treatment","sampling_method":"","gender":"All","minimum_age":45,"maximum_age":60,"population":"","criteria":"\n        DISEASE CHARACTERISTICS: Newly diagnosed, untreated acute myelogenous leukemia (AML), as\r\n        follows: Any cytological type according to the FAB classification At least 30% blast cells\r\n        in bone marrow smear required Secondary acute leukemia eligible, i.e.: AML cured Hodgkin's\r\n        disease or other malignancy AML following exposure to alkylating agents or radiation The\r\n        following are specifically excluded: Blast crisis of chronic myeloid leukemia Leukemia\r\n        supervening after other myeloproliferative disease Leukemia supervening after overt\r\n        myelodysplastic disorder (e.g., refractory anemia with excess blasts) of more than 6\r\n        months' duration\r\n\r\n        PATIENT CHARACTERISTICS: Age: 45-60 Patients 10-45 are eligible for EORTC-06863 Performance\r\n        status: Not specified Hematopoietic: Not specified Hepatic: No severe concomitant hepatic\r\n        disease Renal: No severe concomitant renal disease Cardiovascular: No severe concomitant\r\n        cardiac disease Other: No severe concomitant neurological disease No other progressive\r\n        malignant disease\r\n\r\n        PRIOR CONCURRENT THERAPY: Biologic therapy: No prior therapy Chemotherapy: No prior\r\n        chemotherapy Endocrine therapy: No more than 7 days of corticosteroids for AML\r\n        Radiotherapy: No prior radiotherapy Surgery: Not applicable\r\n      ","sponsor":"European Organisation for Research and Treatment of Cancer - EORTC","sponsor_type":"Other","conditions":"Leukemia","interventions":[{"intervention_type":"Biological","name":"Biological: sargramostim"},{"intervention_type":"Drug","name":"Drug: amsacrine"},{"intervention_type":"Drug","name":"Drug: cytarabine"},{"intervention_type":"Drug","name":"Drug: daunorubicin hydrochloride"},{"intervention_type":"Procedure","name":"Procedure: quality-of-life assessment"}],"outcomes":[{"outcome_type":"primary","measure":"Disease-free survival and overall survival in patients who achieve complete remission after induction"},{"outcome_type":"primary","measure":"Toxicity"},{"outcome_type":"primary","measure":"Quality of life"},{"outcome_type":"primary","measure":"Improved therapeutic results as measured by activation of leukemic cells into the cell cycle and/or acceleration of hematopoietic recovery"},{"outcome_type":"primary","measure":"Relative efficacy of autologous bone marrow therapy"}]}
{"nct_id":"NCT00000501","start_date":"1981-09-30","phase":"Phase 2","brief_title":"Hypertension Prevention Trial (HPT) Feasibility Study","study_type":"Interventional","rec_status":"Completed","completion_date":"1986-08-31","last_update":"2013-11-26","description":"To test the feasibility and the efficacy of nutritional interventions in the primary prevention of hypertension in individuals predisposed to the development of hypertension; specifically, to test the hypothesis that reduction of weight and/or decreased sodium intake in obese individuals, or decreased sodium intake with or without increased potassium intake (in men and women, regardless of weight) would prevent the elevation of blood pressure and the incidence of hypertension.","other_id":"20","allocation":"Randomized","primary_purpose":"Prevention","sampling_method":"","gender":"All","minimum_age":25,"maximum_age":49,"population":"","criteria":"\n        Men and women, ages 25 to 49. Diastolic blood pressure between 78 and 89 mm Hg. Free of\r\n        major disease. Not on a special diet or antihypertensive medication at entry. Some mild to\r\n        moderately obese subjects.\r\n      ","sponsor":"National Heart, Lung, and Blood Institute (NHLBI)","sponsor_type":"NIH","conditions":"Cardiovascular Diseases|Heart Diseases|Hypertension|Obesity|Vascular Diseases","interventions":[{"intervention_type":"Behavioral","name":"Behavioral: diet, sodium-restricted"},{"intervention_type":"Behavioral","name":"Behavioral: diet, reducing"},{"intervention_type":"Drug","name":"Drug: potassium"}],"outcomes":{}}
{"nct_id":"NCT00001151","start_date":"1976-03-31","phase":"Phase 2","enrollment":6,"brief_title":"Studies With 1,25-Dihydroxycholecalciferol","official_title":"Studies With 1,25-Dihydroxycholecalciferol","primary_completion_date":"2009-10-31","study_type":"Interventional","rec_status":"Terminated","completion_date":"2009-10-31","last_update":"2013-11-25","description":"Vitamin D in the diet undergoes changes in the liver and kidneys to several forms. Patients suffering from disorders with Vitamin D resistance are unable to absorb calcium from food. Patients diagnosed with these disorders will be evaluated and treated with high doses of another form of Vitamin D (1,25-dihydroxyvitamin D3). Patients will be monitored and observed throughout the study to avoid experiencing side effects from the medication.","other_id":"760081","allocation":"N/A","intervention_model":"Single Group Assignment","primary_purpose":"Treatment","masking_description":"None (Open Label)","sampling_method":"","gender":"All","population":"","criteria":"\n        -  INCLUSION CRITERIA:\r\n\r\n        Patients with hereditary resistance to calcitrol.\r\n      ","sponsor":"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","sponsor_type":"NIH","conditions":"Hypocalcemia|Rickets","interventions":[{"intervention_type":"Drug","name":"Drug: 1,25-Dihydroxycholecalciferol","description":"Usual doses of 1,25-dihydroycholecalciferol are 0.25-1 ug per day. All patients in this study received very high doses or 5-20 ug per day."}],"outcomes":[{"outcome_type":"primary","measure":"Number of Participants With Normal Serum Calcium Concentrations","time_frame":"1 year average","description":"Normal calcium concentration 8.2-10.6 mg/dL"}]}